t versus Low Fat Diet|"We propose a randomized controlled clinical trial to evaluate the effectiveness of a low-glycemic load diet versus low-fat diet on insulin sensitivity, body composition, and other hormonal and biochemical measures. The culturally competent and family-based Intervention program has a dietary experimental component (low-glycemic load versus low-fat diet), as well as elements of physical activity, reduction in sedentary behavior and behavior modification. The nutrition training sessions are divided into 12 modules taught over a 12-week course. Care has been taken to make the content and intensity of the low-fat and low-glycemic load programs comparable. Both treatments include 12 weekly sessions, followed by nine monthly, and four 3-monthly sessions.
~Participants are obese (BMI ≥95th percentile for age and sex) Hispanic American children ages 7-14 years."
16242175|NCT01068184|Drug|AZD6553|Single or multiple oral dose
16242176|NCT01068184|Drug|Placebo|single or multiple oral dose
16242177|NCT01068171|Other|type of footwear|comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored
16242178|NCT01068171|Other|collagen dressing with and without silver|silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months
16242179|NCT01068158|Drug|0.5% Ivermectin Cream|Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1.
16242180|NCT01068158|Drug|Placebo control|up to 4 ounces of topical vehicle control to head and scalp on day 1.
16242181|NCT01068145|Drug|SCH 527123|Very low dose SCH 527123, once daily for 7 days
16242182|NCT01068145|Drug|SCH 527123|Low dose SCH 527123, once daily for 7 days
16242183|NCT01068145|Drug|SCH 527123|Medium dose SCH 527123, once daily for 7 days
16242184|NCT01068145|Drug|SCH 527123|High dose SCH 527123, once daily for 7 days
16242185|NCT01068145|Drug|Placebo|Placebo capsules to match SCH 527123, once daily for 7 days
16242186|NCT01068145|Drug|SCH 527123|Low dose capsule SCH 527123, once daily for 14 days
16242187|NCT01068145|Drug|SCH 527123|Medium dose capsule SCH 527123, once daily for 14 days
16242188|NCT01068145|Drug|SCH 527123|High dose capsule SCH 527123, once daily for 14 days
16242189|NCT01068145|Drug|Placebo|Placebo capsules to match SCH 527123, once daily for 14 days
16242190|NCT01068132|Drug|Cetuximab|cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1,
16242191|NCT01068132|Drug|FOLFIRI|irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
16242192|NCT01068119|Procedure|Same-day discharge|Patients identified as clinically stable are discharged home the same day as the PCI procedure with telephone follow-up at 12 hr, 24 hr, 3, 30, 180 and 365 days post procedure.
16242193|NCT01068106|Device|Nobori® (Biodegradable polymer limus-eluting stents)|due randomization biodegradable polymer limus-eluting stents will be implanted
16242194|NCT01068106|Device|Xience-V® (Permanent polymer limus-eluting stent)|due randomization permanent polymer limus-eluting stent will be implanted
16242195|NCT01068093|Drug|Ezetimibe|10mg daily
16242196|NCT01068067|Other|drug (tacrolimus and SchE) and genetics|Patients were genotyped for the polymorphisms that can influence tacrolimus pharmacokinetics before transplantation. After transplantation, initial tacrolimus dosage was based on an algorism guided by pharmacogenetics and SchE.
16242197|NCT01068067|Drug|tacrolimus|After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).
16242198|NCT01068054|Drug|tacrolimus|0.1% ointment,apply bid, 8 weeks
16242199|NCT01068054|Drug|cyclosporins|2% eyclosporine eye drops apply 1 drop to each eye QID
16242200|NCT01068041|Drug|PH3|Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
16242201|NCT01068028|Drug|ORM-12741|Ascending multiple doses to sequential panels
16242202|NCT01068028|Drug|Placebo for ORM-12741|
16242203|NCT01068015|Other|behavior intervention and male circumcision|MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.
16242204|NCT01067989|Drug|Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)|"Cyclophosphamide Tab. 50mg, 1x1/day, continuously.
~Capecitabine Tab. 500mg, 1+2/day, continuously.
~Methotrexate Tab. 2.5mg, 1x2/day, 2 days every week.
~Celecoxib Tab. 200mg, 1x2/day, continuously.
~Pamidronate I.V. 90mg, every 4 weeks; or Zoledronate I.V. 4mg, every 4 weeks)"
16242205|NCT01067976|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight
16242206|NCT01067963|Behavioral|Computer assisted education and motivational interviewing.|9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.
16242207|NCT01067963|Behavioral|Group talks/social chat|9 study contact points. 3 group talk session on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
16242208|NCT01067950|Procedure|Isolated Pancreas Transplant|
16242209|NCT01067950|Drug|Intensive Insulin Therapy|
16242210|NCT01067937|Procedure|appendectomy|Randomisation will apply to the 8 participating centers as follow: During a first survey period of 6 month, the algorithm is not applied; The six following months, 4 randomised centers applied the algorithm, the others being still survey; The six last month, all centers will apply the algorithm
16242211|NCT01067924|Behavioral|Motivational interviewing|Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program. Motivational interviews will occur at the end of the structured program and at 3 months post program completion. Outcomes will be collected at 6 months post-program.
16242212|NCT01067911|Dietary Supplement|Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola|Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
16242213|NCT01067911|Dietary Supplement|In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter|Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
16242214|NCT01067911|Dietary Supplement|In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter|Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
16242215|NCT01067911|Dietary Supplement|In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter|Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
16242216|NCT01067898|Dietary Supplement|vitamin D3 (cholecalciferol)|vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.
16242217|NCT01067898|Other|olive oil|10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
16242218|NCT01067898|Dietary Supplement|calcium carbonate|1000 mg calcium per os every day for one year
16242219|NCT01067885|Device|MARIS-stent (Invatec)|stenting of SFA with Maris nitinol stent/s
16242220|NCT01067859|Drug|Cinaciguat (BAY58-2667)|Infusion of 25 µg/h during 48 hours
16242221|NCT01067859|Drug|Cinaciguat (BAY58-2667)|Infusion of 10 µg/h during 48 hours
16242222|NCT01067859|Drug|Placebo|Infusion of placebo during 48 hours
16242223|NCT01067846|Drug|Seromycin (D-cycloserine, DCS)|250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
16242224|NCT01067846|Drug|Placebo|Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
16242225|NCT01067846|Behavioral|Computerized Cognitive Behavioral Therapy|All participants received Computerized Cognitive Behavioral Therapy sessions 3 times per week for 4 weeks as a drug relapse intervention.
16242226|NCT01067833|Drug|K201 Tablet|oral tablet, x28 days
16242227|NCT01067833|Drug|Placebo Tablet|oral tablet, x28 days
16242228|NCT01067820|Drug|RVX000222|capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 26 weeks
16242229|NCT01067820|Drug|Placebo RVX000222|capsule, administer with food, twice daily 10-12 hrs apart, 26 weeks
16242230|NCT01067807|Drug|25 mg Proellex|25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose
16242231|NCT01067807|Drug|25 mg Proellex|25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose
16242232|NCT01067807|Drug|25 mg Proellex|25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose
16242233|NCT01067807|Drug|50 mg Proellex|50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose
16242234|NCT01067794|Drug|Any platinum-based doublet chemotherapy|Dosage, dosage form, frequency and duration according to daily hospital practice
16242235|NCT01067781|Biological|Heat-Labile Enterotoxin of E. coli (LT)|Travelers' Diarrhea Vaccine System
16242236|NCT01067781|Biological|Placebo|Travelers' Diarrhea Vaccine System
16242237|NCT01067768|Other|Daily review|"Daily nursing review of the urinary catheter´s indication. If the patient meets at least one of the entries to stay with bladder catheter, the nurse will record collection in the format but will not contact the health team. If there aren´t indication in the medical record, she contacts at the attending physician and said: Doctor, I didn´t find record in the history of the indication of the urinary catheter, can we withdraw?. If the physician reported the indication, will be recorded in the format without additional comments.
~The attending physician decides withdraw or no withdraw the urinary catheter"
16242238|NCT01067755|Device|LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation)|LungPoint Virtual Bronchoscopic Navigation is a product that displays images and information to aid bronchoscopists in guiding the bronchoscope and other instruments to a target location in the lung airways.
16242239|NCT01067729|Device|AWBAT Wound Dressing|
16242240|NCT01067729|Device|AWBAT™, Biobrane®|Comparison of burn dressings on randomized body sites using patient as own control
16242241|NCT01067716|Device|STAR S4IR LASIK with VSS-R ablation profile|LASIK treatment targeted for emmetropia
16242242|NCT01067703|Procedure|Remote Ischemic Preconditioning|RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.
16242243|NCT01067703|Procedure|Control/sham procedure (blood pressure cuff)|Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.
16242244|NCT01067690|Drug|Indinavir in association with Vinblastina +/- Bleomicina|Treatment consists in an induction phase where daily Indinavir (800 mg x 2/die, orally) will be combined together with systemic Vinblastine (10 mg intravenously) +/- Bleomycin (15 mg intramuscularly) in cycles administered every 3 weeks. As maximal response will occur, patients will undergo 2 additional Vinblastine +/- Bleomycin (consolidation) cycles upon continuous treatment with Indinavir. This will be followed by a maintenance phase with Indinavir alone (800 mg x 3/die, orally) in responder patients.
16242245|NCT01067677|Drug|Metaclopramide|0.5 mg/kg for rescue after PONV
16242246|NCT01067677|Drug|Ondansetron|0.1 mg/kg (max 4 mg0
16242247|NCT01067677|Drug|diphenhydramine|0.25 mg/kg (max 25 mg)
16242248|NCT01067677|Drug|Saline|equal volume (5 ml)as experimental rescue medications
16242249|NCT01067651|Device|Plaster of Paris (POP) casting using the Ponseti Method|
16242250|NCT01067651|Device|Semi-Rigid Fiberglass softcast using the Ponseti Method|
16242251|NCT01067638|Drug|Tranexamic Acid|1.0g loading dose before skin incision and continuous infusion 200 mg/h during surgery
16242252|NCT01067625|Device|TOGA® System|Formation of restrictive sleeve via transoral gastric stapling for treatment of obesity
16242253|NCT01067599|Other|Low nicotine|Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
16242254|NCT01067599|Other|Medium nicotine|Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
16242255|NCT01067599|Other|High nicotine|Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
16242256|NCT01067547|Drug|Iron Sucrose.|The total dose of iron sucrose given will be individualised by calculating their iron deficit.
16242257|NCT01067547|Drug|Iron sucrose|300mg of iron sucrose is given intravenously. Three infusions, each one week apart is given to patients with iron deficiency without anemia. For those patient with anemia, four infusions would be given.
16242258|NCT01067534|Drug|Salbutamol|Inhaler salbutamol 0,1 mg/dose - 4 doses=0,4 mg
16242259|NCT01067521|Drug|Glatiramer acetate (GA)|GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period.
16242260|NCT01067521|Drug|Placebo|Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.
16242261|NCT01067508|Other|Fiji Water|Participants are asked to drink one liter of this silicon-rich water daily for three months.
16242262|NCT01067495|Behavioral|Cardiac rehabilitation|Participants will participate in a 6-month cardiac rehabilitation exercise program. This program will include aerobic and resistance training, and education sessions on risk factor management.
16242263|NCT01067469|Drug|Standard Dose Bevacizumab|10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
16242264|NCT01067469|Drug|Low Dose Bevacizumab|5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle.
16242265|NCT01067469|Drug|Lomustine|Starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.
16242266|NCT01067456|Radiation|Comprehensive Cardiothoracic CT arm|Subjects in this arm will receive the comprehensive cardiothoracic CT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
16242267|NCT01067443|Drug|Liposomal amphotericin B (AmBisome®) and sodium stibogluconate|AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
16242268|NCT01067443|Drug|Liposomal amphotericin B + miltefosine|AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
16242269|NCT01067443|Drug|Miltefosine|Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
16242270|NCT01067430|Drug|Etoricoxib|Film coated tablet, 90 mg taken once a day for 14 days
16242271|NCT01067430|Drug|Diclofenac|Enteric coated tablet 50 mg given three times a day for 14 days
16242272|NCT01067417|Drug|Hydroxychloroquine|Taken orally 2x200mg capsules once daily for 48 weeks
16242273|NCT01067417|Drug|Placebo|Taken orally 2x200mg capsules once daily for 48 weeks
16242274|NCT01067404|Biological|Trivalent inactivated influenza vaccine|0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV)
16242275|NCT01067391|Drug|tadalafil|20 mg tablet, administered once per study protocol
16242276|NCT01067391|Drug|placebo|placebo tablet administered once per study protocol
16242277|NCT01067378|Other|Peer-led debriefing|
16242278|NCT01067378|Other|Expert instructor debriefing|
16242279|NCT01067365|Drug|Androxal|12.5 mg once daily
16242280|NCT01067365|Drug|Androxal|25 mg once daily
16242281|NCT01067352|Drug|Recombinant human growth hormone (r-hGH)|Recombinant human GH were administered subcutaneously (s.c) at the daily dose of 0.067 mg/kg of body weight to Group A1.
16242282|NCT01067339|Drug|darapladib|darapladib, tablet, 160 mg, by mouth, one time daily, 6 month duration
16242283|NCT01067339|Drug|placebo|placebo, by mouth, once daily for six months
16242284|NCT01067326|Drug|Aliskiren|150 mg Aliskiren once daily for a period of 4 months
16242285|NCT01067326|Drug|Placebo|1 pill per day by mouth for 4 months
16242286|NCT01067313|Device|Dialyzer Ultraflux EMiC2|Dialysate flow rate = 40 ml/kg/h The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.
16242287|NCT01067313|Device|Dialyzer Ultraflux AV1000S|Ultrafiltration flow rate = 40 ml/kg/h The blood flow rate will be adjusted to obtain a filtration fraction of 20%. Reinjection = 100% postdilution. The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.
16242288|NCT01067300|Procedure|Transplantation of unrelated cord blood unit(s)|Myeloablative conditioning regimen includes, according to the patient age, either total body irradiation, fludarabine and cyclophosphamide with a GvHD prophylaxis based on cyclosporine A and mycophenolate, or the association busulfan, cyclophosphamide and anti-thymocyte globulin with GvHD prophylaxis being cyclosporine A and steroids.
16242289|NCT01067287|Drug|CT-011|Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses
16242290|NCT01067287|Biological|Dendritic Cell Fusion Vaccine|One week following each infusion of CT-011
16242291|NCT01067274|Drug|Vesanoid (ATRA)|45 mg/m2/day in two divided doses from D8 to D28
16242292|NCT01067274|Drug|AZACITIDINE (VIDAZA)|75 mg/m2/12h SC from D1 to D5
16242293|NCT01067274|Drug|CYTARABINE|Cytarabine : 60 mg/m2/12h SC from D1 to D5
16242294|NCT01067261|Device|Transcutaneous mechanical nerve stimulation (TMNS)|"Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)
~A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum. A stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used. The treatment will be initiated 1 to 4 weeks before the radical prostatectomy and re-initiated 0 to 14 days after the operation. The treatment will then continue for 6 weeks. The stimulation will be preformed daily by the patients in their own homes."
16242295|NCT01067261|Other|Pelvic floor muscle training|Regular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital.
16242296|NCT01067235|Drug|BF2.649|BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
16242297|NCT01067235|Drug|BF2.649 add on Modafinil|BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
16242298|NCT01067222|Drug|BF2.649|BF2.649 oral capsules at 10 or 20 or 40 mg per day
16242299|NCT01067222|Drug|Modafinil|Modafinil oral capsules at 100 or 200 or 400 mg per day
16242300|NCT01067222|Drug|Placebo|Placebo oral capsules, 4 capsules per day
16242301|NCT01067183|Behavioral|portable biofeedback tool and relaxation breathing technique|The intervention group were trained in relaxation breathing technique and the use of a portable biofeedback tool that informs them of the success of the technique...thus behavioral therapy using a biofeedback device
16242302|NCT01067170|Device|Pneumatic Compression Stockings|Thigh-high pneumatic compression stockings
16242303|NCT01067157|Behavioral|LOGIC|"Experimental group:
~Diet (1200-1800 kcal/d), Exercise: 11 h/wk physical activity, Behavioural therapy (group training, 1-3h/wk individualized personal instructions, 2 h parents work)"
16242304|NCT01067144|Drug|Gabapentin|1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
16242305|NCT01067144|Drug|Lorazepam (active control)|0.5 mg Lorazepam (active control) given pre-operatively in a single dose.
16242306|NCT01067144|Drug|Placebo (inactive)|2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.
16242307|NCT01067131|Biological|PEV7C1|capsule intravaginal application contains antigen coupled to virosomes
16242308|NCT01067131|Biological|PEV7C9|capsule intravaginal application contains excipient only
16242309|NCT01067131|Biological|PEV7B2|reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes
16242310|NCT01067131|Biological|PEV7B1|reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes
16242311|NCT01067118|Drug|LINjeta U-100 Insulin|LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
16242312|NCT01067118|Drug|Humalog U-100|Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors
16242313|NCT01067105|Drug|ciclesonide HFA 160 μg|ciclesonide HFA 160 μg once daily
16242314|NCT01067092|Behavioral|Community Health Worker Intervention|A Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
16242315|NCT01067092|Behavioral|Educational Newsletter|Diabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period. The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
16242316|NCT01067079|Other|No vaccine administered; subjects only have blood sampling for immunogenicity|No vaccine administered; subjects only have blood sampling for
16242317|NCT01067066|Drug|TPI 287|Starting dose cycle 1, 90 mg/m2 by vein (IV) on Days 1, 8, 15 (+/- 1 day)
16242318|NCT01067066|Drug|Temodar (Temozolomide)|Starting dose cycle 1, 85 mg/m^2 by mouth (PO) daily, Day 1 to 5.
16242319|NCT01067053|Drug|bevacizumab, capecitabine, oxaliplatin|"6 cycles (3 weeks each one) of:
~bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle.
~capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
~oxaliplatin: 130/mg/m2(iv),1st day of each cycle.
~After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine"
16242320|NCT01067027|Dietary Supplement|Lactobacillus reuteri|5 drops of study product 30 minutes before feeding.
16242321|NCT01067014|Device|Baxano iO-Flex® System|Decompressive lumbar surgery using Baxano iO-Flex® System
16242322|NCT01066988|Other|ORB Ocular Emulsion|lubricant eye drop
16242323|NCT01066988|Other|SootheXP Emollient (Lubricant) Eye Drops|lubricant eye drop
16242324|NCT01066962|Drug|darunavir/ritonavir QD + raltegravir BID|"darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)
~ritonavir 100 mg, 1 tablet once daily (QD)
~raltegravir 400 mg, 1 tablet twice daily (BID)"
16242325|NCT01066962|Drug|darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)|"darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)
~ritonavir 100 mg, 1 tablet once daily (QD)
~tenofovir/emtricitabine 245/200 mg, fixed dose combination, 1 tablet once daily (QD)"
16242326|NCT01066949|Behavioral|Behavioral self mangement|Seven weekly, hour long group sessions focused on enhancing patient behavioral self management skills.
16242327|NCT01066949|Behavioral|Support and discussion|Seven, weekly hour long group sessions focused on information provision and supportive discussion amongst participants
16242328|NCT01066923|Drug|Daily aspirin (ASA)|Two weeks 82 mg aspirin taken orally prior to exercise protocol
16242329|NCT01066923|Other|Active cooling|Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
16242330|NCT01066923|Drug|Acute aspirin (ASA)|325 mg chewable aspirin administered immediately following exercise
16242331|NCT01066923|Other|Passive cooling|Removing protective garments for passive cooling following exercise
16242332|NCT01066923|Drug|Daily placebo|Placebo comparator for daily aspirin therapy
16242333|NCT01066923|Drug|Acute placebo|Placebo comparator for acute aspirin therapy
16242334|NCT01066910|Behavioral|Behavioral treatment for childhood obesity|Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
16242335|NCT01066910|Behavioral|Behavioral treatment for childhood obesity|Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
16242336|NCT01066897|Drug|Pramipexole|Patients will received increasing dose of pramipexole
16242337|NCT01066884|Drug|erlotinib [Tarceva]|150mg po daily
16242338|NCT01066871|Drug|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) will be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
16242339|NCT01066871|Drug|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) will be administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
16242340|NCT01066871|Drug|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
16242341|NCT01066871|Other|Placebo|Placebo matched to sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 consecutive weeks.
16242342|NCT01066858|Drug|Tenofovir disoproxil fumarate (TDF)|Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE).
16242343|NCT01066845|Drug|tadalafil|prescribed in accordance with usual clinical practice
16242344|NCT01066832|Drug|Paclitaxel|Paclitaxel-coated balloon (3 µg/mm2)
16242345|NCT01066819|Drug|Peginterferon alfa-2a [Pegasys]|Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
16242346|NCT01066819|Drug|Peginterferon alfa-2b [PegIntron®]|Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
16242347|NCT01066806|Behavioral|counseling on increasing calcium intake|The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.
16242348|NCT01066806|Other|observation|observe normal dairy intake
16242349|NCT01066793|Drug|Peginterferon alfa-2a [Pegasys]|Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
16242350|NCT01066793|Drug|Peginterferon alfa-2b [PegIntron®]|Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
16242351|NCT01066780|Device|ClearVoice|ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)
16242352|NCT01066767|Drug|Fexofenadine|Fexofenadine Hydrochloride 180 mg Tablets
16242353|NCT01066754|Drug|Fexofenadine|Fexofenadine Hydrochloride 180 mg Tablets
16242354|NCT01066741|Drug|Homeodent®|Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.
16242355|NCT01066741|Drug|1.4% Sodium Bicarbonate solution|Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing
16242356|NCT01066728|Other|CO2 inhalation|Inhalation of CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days
16242357|NCT01066728|Drug|Theophylline|
16242358|NCT01066715|Drug|XOMA 052|Sterile solution subcutaneously administered monthly for 6 months
16242359|NCT01066715|Drug|Placebo|Sterile solution subcutaneously administered monthly for 6 months
16242360|NCT01066702|Biological|NeoCart|implantation of an cartilagenous tissue implant derived from the patients own cells.
16242361|NCT01066702|Procedure|Microfracture|holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
16242362|NCT01066689|Drug|MabThera|MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
16242363|NCT01066689|Drug|Physiological serum (Sodium Chloride, sodium citrate)|Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
16242364|NCT01066676|Drug|Dexibuprofen|400mg powder for oral suspension, daily dose 800mg
16242365|NCT01066676|Drug|Ibuprofen|400mg, powder for oral suspension, daily dose 1600mg
16242366|NCT01066663|Drug|pyrimethamine|Taken orally once a day
16242367|NCT01066650|Device|Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)|Drug eluting Stent
16242368|NCT01066650|Device|Xience V (Everolimus-eluting stent)|Drug eluting stent
16242369|NCT01066637|Drug|[18F](+/-)NOS|Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis
16242370|NCT01066624|Drug|0.9% Sodium Chloride irrigation solution|Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study
16242371|NCT01066624|Other|Cryotherapy (ice chips)|Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion.
16242372|NCT01066624|Device|Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse|Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
16242373|NCT01066611|Drug|CAL-263|CAL-263 10 mg or placebo once daily for 7 days
16242374|NCT01066611|Drug|Placebo|CAL-263 10 mg or placebo once daily for 7 days
16242375|NCT01066598|Drug|Rituximab|Rituximab 375 mg/m2 IV weekly X 4 doses + Prednisone 1 mg/kg/d
16242376|NCT01066585|Drug|Ivermectin Cream|Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1
16242377|NCT01066585|Drug|vehicle control|Up to 4 ounces of vehicle control applied to the hair and scalp on day 1
16242378|NCT01066572|Drug|Lisinopril|5-10 mg Lisinopril per day for seven days, depending on blood pressure.
16242379|NCT01066572|Drug|Placebo|Matched placebo; identical tablets to Lisinopril.
16242380|NCT01066559|Procedure|High flux polymethylmetacrylate membrane|Patients will be hemodialysed with high flux polymethylmetacrylate membranes
16242381|NCT01066559|Procedure|Polysulfone membrane|Patients be hemodialysed with polysulfone membranes
16242382|NCT01066559|Biological|Hepatitis B serological control|It will be assessed at week 16, week 20 and week 40
16242383|NCT01066559|Biological|Seric sCD40 level|Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
16242384|NCT01066546|Drug|Dimebon tablet for oral administration|10 mg TID for Week 1, followed by 20 mg TID for remainder of study
16242385|NCT01066533|Other|direct pulp capping and covering the exposed pulp|In this arm 16 premolar teeth scheduled for extraction for orthodontic reasons were used.After signed consent was given by patients,local anesthesia was applied before operative procedures. Operative procedures were performed with rubber dam placement and disinfected with 2% chlorhexidine gluconate. Class I occlusal cavities were prepared with ¼ round carbide burs under air-distilled water cooling. At the exposure site hemorrhage was controlled by sterile cotton pellets, saline and 5.25% NaOCl.In this group MTA was mixed on a slab according to manufacture's instructions.Then MTA was carried with a carrier to exposed pulp and it was packed with a slight pressure by moist cotton pellet to completely cover the exposed pulp.The cavities were sealed immediately with Fuji II glass ionomer.The teeth were then followed and extracted(8 teeth after 2 weeks and 8 teeth after 8 weeks)
16242386|NCT01066533|Other|direct pulp capping and covering the exposed pulp|In this arm 16 premolar teeth scheduled for extraction for orthodontic reasons were used.All the procedure was carried the same as the other group.But NEC cement was used as pulp capping material.It was mixed with its liquid to provide a dense creamy mixture and then was applied on exposed pulp.the cavities were immediately sealed with Fuji II glass ionomer.The patients were followed and 8 teeth were extracted after 2 weeks and 8 teeth were extracted after 8 weeks.
16242387|NCT01066520|Drug|Traumeel S ointment|2 g, 3 times daily topical during 14 days
16242388|NCT01066520|Drug|Traumeel S gel|2 g, 3 times daily topical during 14 days
16242389|NCT01066520|Drug|Diclofenac gel|2 g, 3 times daily topical during 14 days
16242390|NCT01066494|Drug|Amonafide + cytarabine|Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7
16242391|NCT01066481|Drug|PF-01913539 5 mg|PF-01913539 5 mg three times daily for 6 months
16242392|NCT01066481|Drug|PF-01913539 5 mg|PF-01913539 5 mg three times daily for 6 months
16242393|NCT01066481|Drug|Placebo|Placebo three times daily for 6 months
16242394|NCT01066468|Drug|Gleevec/Glivec|
16242395|NCT01066442|Drug|BF2.649 (Pitolisant)|1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
16242396|NCT01066429|Drug|Dexamethasone and dose-dense immunochemoterapy|Administration every 14 days of the EDOCH-R scheme.
16242397|NCT01066416|Procedure|Endoscopic Sinus Surgery|
16242398|NCT01066416|Other|medical therapy|Subjects will undergo surgery 6 months after randomization
16242399|NCT01066403|Drug|Pergolide|"0,3 mg pergolide (the first two days begin with 0,05mg, then increase of dose of 0,1mg every 3 days for a maximum of 0,3mg/d, taken orally 3x 0,1mg/day). Then stable dose of 0,3mg for one week.. Subsequently slow (for 8 days) reduction of dosage of 0,1mg every 3 days for 6 days then 0,05mg every day for the last two days.
~Placebo group is identical in appearance and number of placebo capsules, in the same starting and maintenance scheme as for the pergolide group."
16242400|NCT01066390|Biological|TriMix-DC|eligible patients will undergo a leucapheresis for the preparation of autologous TriMix-DC vaccine.4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks.
16242401|NCT01066377|Dietary Supplement|Prebiotic and probiotic mix|The probiotic strain will be Bifidobacterium longum bv. infantis CCUG 52486 (10^8 - 10^9 live bacteria per day), which was originally isolated from healthy elderly subjects, and which has been demonstrated to have particular ecological fitness and anti-pathogenic effects in vitro. A suitable prebiotic (8g/day) will be selected on the basis of ability to promote optimal growth and survival of this probiotic (inulin, fructooligosaccharides [FOS], galactooligosaccharides[GOS] and xylooligosaccharides[XOS] will be tested).
16242402|NCT01066364|Drug|Colesevelam Hcl|3.75 gm/day (six 675 mg tablets)
16242403|NCT01066351|Drug|beta erythropoietin|The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.
16242404|NCT01066351|Drug|placebo|The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
16242405|NCT01066325|Behavioral|Neuro Emotional Technique|"NET is considered an alternative stress-reduction technique. Its aim is to remove neurological abnormalities which have a specified physiopathological pattern. The goal of NET is to normalize the aberrant patterns through a physical correction.
~During the NET procedure, various psychological components of the anxious state are considered: cognitions, emotions, and behaviours. These various components are explored for a physiological reaction in the participant. Once a physiological reaction is found, the practitioner helps the participant identify the specific emotion. The procedure is concluded when the patient no longer feels distress or discomfort. Following the intervention, patients frequently report feeling subjective relief."
16242406|NCT01066325|Other|Stretching Instruction|This arm is the Active Control Arm and will receive two 20-minute sessions of Stretching Instructions. During these instructions, participants will hold stretches for not longer than 5 seconds, which in not likely to have any therapeutic effect.
16242407|NCT01066299|Drug|Syntocinon®|single dose of OXT (24 IU)
16242408|NCT01066299|Drug|inactive nasal spray|single dose (24 IU)
16242409|NCT01066273|Device|P-Stim|The P-Stim is a battery-powered, transcutaneous electrical stimulator that delivers 1 per second bipolar 1 millisecond pulses to three points on the auricle. The device connects via three fine insulated stainless steel wires to three needles (each 0.4 mm diameter, 2 mm long) that have been applied to three different points on the auricle. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours. The battery and electronics are contained in a 6 mm by 2.5 mm pack that has one adhesive surface which is applied to the skin behind the ear. The adhesive is conductive and acts as the return for the device. The battery pack is secured with tape.
16242410|NCT01066260|Dietary Supplement|Probiotic formulation|Twice a day for 24 days
16242411|NCT01066260|Other|Placebo|Twice a day for 24 days
16242412|NCT01066247|Drug|Morphine hydrochloride; Midazolam|intramuscular morphine 10 mg given 30 minutes before spinal blockade performing
16242413|NCT01066247|Drug|Midazolam|intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
16242414|NCT01066234|Radiation|concurrent chemoradiotherapy|weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.
16242415|NCT01066234|Drug|chemotherapy only|four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).
16242416|NCT01066195|Drug|iressa|iressa 250mg per day every day
16242417|NCT01066195|Drug|alimta|alimta 500mg/m2 every 3 weeks
16242418|NCT01066182|Dietary Supplement|DHA (docosahexaenoic acid)|3 x 500 mg capsules per day orally, each capsule providing 200 mg of DHA as a triglyceride. The liquid fill contains DHASCO®-S oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).
16242419|NCT01066182|Dietary Supplement|Sunflower oil capsules|The placebo will consist of 3 x 500 mg capsules per day orally containing high-oleic sunflower oil. The dimensions, taste, appearance and colour will be identical to those of the DHA capsules. The shell of the capsule will be the same as the DHA capsule. The liquid fill contains high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitat and rosemary extract (flavouring).
16242420|NCT01066169|Biological|Foceteria® (Novartis)|This is not an interventional study. In this observational study we monitored the immune response in a cohort of people who were vaccinated during the national vaccination campaign. The vaccine that was used in The Netherlands is the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine. It contains 7,5 µg hemagglutinine and the MF59C.1 adjuvant, which is an oil-in-water emulsion, composed of Squalene 9.75 mg, Polysorbate 80 1.175 mg and Sorbitan trioleate 1.175 mg. This vaccine has been approved for use according to a two dose schedule.
16242421|NCT01066156|Drug|Seroquel|This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
16242422|NCT01066143|Drug|Seroquel XR|Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
16242423|NCT01066130|Behavioral|Intensive individualized psychosocial treatment|Each person was given psychosocial treatment and support by a medical social worker a maximum of one time each week for a period of up to 2 years after inclusion. Treatment was designed by a medical social work on the basis of the individual's personal needs.
16242424|NCT01066130|Behavioral|Minimal treatment arm|Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.
16242425|NCT01066117|Other|PeeRelease gel absorbent pad|A larger gel containing pad was developed, suitable to absorb up to half a liter liquid, it eliminates odors and enables the users to wear ordinary clothes
16242426|NCT01066104|Drug|Xolair placebo|two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
16242427|NCT01066104|Drug|Xolair (omalizumab)|two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
16242428|NCT01066091|Other|Mashed potatoes|Mashed potatoes: Potatoes + Skim milk powder
16242429|NCT01066091|Other|Mashed potatoes + Oleic acid|Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
16242430|NCT01066091|Other|mashed potatoes + Palmitic acid|Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
16242431|NCT01066078|Other|Echocardiography and SonR recording|
16242432|NCT01066052|Drug|r-hGH|Subcutaneous administration.
16242433|NCT01066039|Drug|Bisoprolol|Bisoprolol tablet will be administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure is not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose will be adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose will be reduced to 2.5 mg.
16242434|NCT01066026|Procedure|hyaluronic acid with metallic cannula or standard needle.|"The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices:
~In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit;
~In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit.
~Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula."
16242435|NCT01066026|Drug|Hyaluronic acid injected with the new tool.|hyaluronic acid with metallic cannula.
16242436|NCT01066013|Other|Antimicrobial de-escalation strategy|The antimicrobial de-escalation team will record recommendations for de-escalation in the patient's progress notes for the attending physicians to review and act upon as appropriate. The attending physician will be responsible for making changes to antimicrobial therapy and following up on patient progress as per the usual practice.
16242437|NCT01066000|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
16242438|NCT01065987|Drug|Tizanidine|Tizanidine HCl Tablets 4 mg
16242439|NCT01065974|Behavioral|Behavior Therapy|Weight loss using CBT and continued CBT during weight loss maintenance.
16242440|NCT01065974|Dietary Supplement|Meal Replacements|Weight loss using CBT and meal replacements.
16242441|NCT01065974|Behavioral|Nutritrol|To make widespread nutritional changes to participants personal food environments.
16242442|NCT01065961|Drug|Decadron|Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.
16242443|NCT01065961|Drug|Saline|Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.
16242444|NCT01065948|Device|Subcutaneous glucose monitoring device|monitor interstitial glucose level every 5 min over 4 hours
16242445|NCT01065935|Drug|ALN-RSV01|Administered by nebulization once daily for 5 days
16242446|NCT01065935|Drug|Normal Saline|Administered by nebulization once daily for 5 days
16242447|NCT01065883|Behavioral|community health worker|community health workers will provide education in the home
16242448|NCT01065883|Behavioral|mailed information|information will be mailed to the home on the same schedule as the experimental intervention
16242449|NCT01065870|Drug|Neoadjuvant gemcitabine, capecitabine, and docetaxel|"6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.
~Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.
~Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment."
16242450|NCT01065870|Drug|Gemcitabine, capecitabine, docetaxel followed by radiotherapy|"6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.
~Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.
~Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.
~Radiotherapy should start 2 to 3 weeks after last planned dose of GTX. Gemcitabine at 750mg/M2 days 5, 12, 26, 33 along with capecitabine 1000 mg bid for 5 days darbepoetin 200ug, every 2 weeks if the hemoglobin is less than 10.5 gms/dl while undergoing radiotherapy.
~Pegfiligastrim 6mg at the end of week 2 if the WBC count is less than 2500 cells/cu mm."
16242451|NCT01065857|Drug|Sodium picosulphate, light magnesium oxide and anhydride citric acid.|2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).
16242452|NCT01065857|Drug|Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.|4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).
16242453|NCT01065844|Drug|Nelfinavir|1250 mg Nelfinavir twice daily Monday - Sunday
16242454|NCT01065831|Behavioral|Motivational interviewing (MINT-TLC)|The MINT-TLC lifestyle intervention lead by lay health advisers will be compared to the health education attention control condition (CC). Twenty churches will participate in the study and each church will be randomly assigned to receive either MINT-TLC or CC. They will be compared on blood pressure reduction, physical activity levels, intake of fruits and vegetables, and weight reduction.
16242455|NCT01065818|Drug|Fluoro-L-Thymidine|4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
16242456|NCT01065805|Biological|18F-FLT|"Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient.
~Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient"
16242457|NCT01065779|Drug|FOSAMAX PLUS|Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.
16242458|NCT01065779|Drug|FOSAMAX PLUS D|Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.
16242459|NCT01065766|Drug|Sitagliptin/metformin|Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.
16242460|NCT01065753|Behavioral|Lifestyle Counseling|Diet control with exercise
16242461|NCT01065740|Other|Patient education|
16242462|NCT01065727|Other|mitoxantrone - immunomodulator|mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
16242463|NCT01065727|Other|natalizumab|monthly natalizumab during 3 years
16242464|NCT01065714|Drug|Hydrogel vehicle|Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.)
16242465|NCT01065714|Drug|Eucerin Lotion|Each morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.)
16242466|NCT01065701|Drug|Dexmedetomidine|Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia
16242467|NCT01065688|Procedure|Roux-en Y reconstruction|surgical procedure
16242468|NCT01065688|Procedure|Billroth-I reconstruction|surgical procedure
16242469|NCT01065675|Other|Medication reconciliation completed by a RN, CPhT, or RPh|To determine which patients benefit the most from medication histories obtained by the RN, CPhT, or RPh. Patients will be admitted as inpatients through the ED with medication histories finalized electronically by the RN at the admitting unit.
16242470|NCT01065662|Drug|temsirolimus|Given on days 1, 8, 15 and 22 of each cycle
16242471|NCT01065662|Drug|cediranib|Taken orally daily
16242472|NCT01065649|Drug|Nortriptyline|It will be administered per oral 10 mg a day in the first 7 days and then 25 mg a day in the last 14 days
16242473|NCT01065649|Drug|Placebo arm|Placebo per oral for 21 days, equal to nortriptyline
16242474|NCT01065636|Behavioral|Diet + Resistance Training|Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
16242475|NCT01065636|Behavioral|Diet + Aerobic Training|Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
16242586|NCT01064856|Biological|Placebo|Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.
16242476|NCT01065636|Behavioral|Diet + Resistance/Aerobic Exercise|Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
16242477|NCT01065623|Drug|BAY79-4620|1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities
16242478|NCT01065610|Drug|Oxytocin|
16242479|NCT01065610|Drug|Placebo|
16242480|NCT01065597|Device|Nonconvulsive electrotherapy|An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
16242481|NCT01065571|Dietary Supplement|carrageenan|The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
16242482|NCT01065571|Other|dietary intervention with no-carrageenan diet|The intervention will consist of the no-carrageenan diet.
16242483|NCT01065558|Drug|Ecopipam|Tablets, once daily, for two weeks up to 200 mg/day
16242484|NCT01065545|Drug|Clofarabine|dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)
16242485|NCT01065532|Device|Sequent Please Paclitaxel eluting balloon|Sequent Please Paclitaxel eluting balloon
16242486|NCT01065532|Device|Xience V everolimus eluting stent|Xience V everolimus eluting stent
16242487|NCT01065519|Device|Xience V everolimus eluting stent|Xience V everolimus eluting stent
16242488|NCT01065519|Device|Biolimus A9-eluting Biomatrix stent|Biolimus A9-eluting Biomatrix stent
16242489|NCT01065506|Behavioral|Cognitive Behavioral Treatment|Cognitive Behavioral Treatment
16242490|NCT01065506|Drug|Nicotine Patch|Nicotine Patch
16242491|NCT01065506|Behavioral|Wellness Program|Wellness Program
16242492|NCT01065506|Behavioral|Aerobic Exercise|Aerobic Exercise
16242493|NCT01065493|Other|QuitAdvisorMD Software Algorithm|QuitAdvisorMD, a set of brief clinical assessments, counseling scripts and intervention instruments for smoking cessation in primary care settings
16242494|NCT01065493|Behavioral|Standard Smoking Cessation Counseling|Standard Smoking Cessation Counseling
16242495|NCT01065480|Behavioral|Live teleconference supervision|Participants receive live teleconference supervision during a session with a client on their use of Motivational Interviewing (MI) in the session. MI is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence. Compared with nondirective counselling, it is more focused and goal-directed. The examination and resolution of ambivalence is its central purpose, and the counselor is intentionally directive in pursuing this goal.
16242496|NCT01065480|Behavioral|Taped Review Supervision|Participants audio record a session with a client and receive supervision after the session on their use of Motivational Interviewing during the session.
16242497|NCT01065467|Drug|LBH589|Taken orally three times per week.
16242502|NCT01065441|Biological|AlloStim|Patients meeting eligibility criteria will be primed with at least three and up to nine intradermal AlloStim-TM injections at a frequency of every 2-8 days at doses between 1-4 x 10^7 cells
16242503|NCT01065441|Procedure|Cryoablation|Percutaneous cryoablation of selected tumor lesion under CT or US guidance
16242504|NCT01065441|Biological|AlloStim|intratumoral injection of AlloStim-TM into cryoablated tumor lesion at a dose of 1-6 x 10^7 cells
16242505|NCT01065441|Biological|AlloStim|intravenous AlloStim-TM at doses between 1 x 10^7 to 1 x 10^9 cells
16242506|NCT01065441|Biological|AlloStim|Intraperitoneal AlloStim-TM infusion in patients with peritoneal carcinomatosis and/or ascites
16242507|NCT01065441|Biological|AlloStim|Patients with malignant pleural effusion may receive intrapleural AlloStim-TM infusion at a dose of 5-10 x 10^7 cells.
16242508|NCT01065441|Biological|AlloStim|Patients with palpable tumors may receive alcohol ablation and intratumoral AlloStim-TM
16242509|NCT01065402|Dietary Supplement|PPB-R-203-Based Meal|PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 is resistant starch (RS). Resistant starch can be regarded as a component of dietary fiber. Some forms of RS are present naturally in many foods, and average global consumption is estimated at 3-10 g/day. PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
16242510|NCT01065402|Dietary Supplement|TK9-Based Meal|TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd. TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
16242511|NCT01065389|Behavioral|Progressive Resistance Exercise Training|Progressive Resistance Exercise Training thrice a week for 12 weeks. For first two weeks, 60% of 5 repetition maximum, progressing at 5% of 5 repetition maximum each week reaching upto 110% of 5 Repetition maximum at the end of 12 weeks
16242512|NCT01065389|Behavioral|Unstructured Nonprogressive resistance exercise|Unstructured Resistance Exercise 30 minutes a day, thrice a week for 12 weeks. For 12 weeks, 20% 5 repetition maximum (which will not induce training effect and any physiological responses)and free range of motion exercises with no progression.
16242513|NCT01065376|Procedure|the timing cabergoline administration|received 0.5 mg oral cabergoline per day for 8 days on the day of hCG
16242514|NCT01065376|Procedure|the timing cabergoline administration|received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval
16242515|NCT01065363|Behavioral|standardized exercise program and dietary counseling|Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks
16242587|NCT01064843|Device|Imtec MDI|4 Imtec MDI
16242588|NCT01064830|Drug|topical cyclosporine ophthalmic suspension 0.05%|apply 2 drops to 2 target fingernails under occlusion daily
16242589|NCT01064830|Drug|vehicle|apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks
16242516|NCT01065350|Drug|Propofol|As part of the induction, subjects will be given 2 milligrams per kilogram of body weight (mg/kg) of propofol. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. The clinician and observer will be blinded to the medication and doses being administered during induction given that both syringes, syringes in the propofol and ketofol groups, will look identical (will both appear to be propofol only). The propofol group will also be given an additional 10 mL syringe of propofol due to any patient responding to stimulus after induction. The 10 mL syringe represents 1 mg/kg of propofol. If patient receives both the 20 and 10ml syringe, he or she will receive a total of 3mg/kg of propofol.
16242517|NCT01065350|Drug|Ketamine|As part of the induction, patients will be given 20ml syringe of ketofol which is weight based such that ketamine will represent 0.75mg/kg of the dose and propofol, 1.5mg/kg. The clinician and observer will be blinded to the medication and doses being administered during induction given that both 20ml syringes (propofol group and ketofol group) will look identical (will both appear to be propofol only). Additional 10ml syringe will be given due to any patient responding to stimulus after induction. The 10ml syringe will represent 0.25mg/kg of ketamine and 0.5mg/kg of propofol. If the patient receives both the 20 and 10ml rescue syringe, he or she will receive a total of 1mg/kg of ketamine and 2mg/kg of propofol.
16242518|NCT01065337|Biological|tissue repair cells (TRC)|expanded bone marrow cells enriched in CD90+ mesenchymal stem cells
16242519|NCT01065337|Biological|bone marrow stem cells (BMC)|bone marrow stem cells
16242520|NCT01065311|Behavioral|Mindfulness-based Cognitive Therapy|Mindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions
16242521|NCT01065311|Behavioral|The Cognitive Behavioral Analysis System of Psychotherapy|The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.
16242522|NCT01065311|Biological|Standard psychiatric care|"Antidepressant medication and medical care.
~Standard psychiatric outpatient care:
~All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist"
16242523|NCT01065298|Biological|stem cell transplantation|Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
16242524|NCT01065285|Biological|Evaluation of vaccines against flu|evaluate efficacy and tolerance
16242525|NCT01065272|Drug|Dexamethasone|"0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
~1mg/kg of oral Dexamethasone with cherry flavour is also given in the first day, then 0.6 mg/kg/day for 4 days"
16242526|NCT01065272|Drug|Placebo|"0.5 ml Salbutamol in 2 ml normal saline is given at 0,30,60,120,180 minutes and then every 2 hourly till discharge.
~1mg/kg of oral Placebo is also given in the first day, then 0.6 mg/kg/day for 4 days"
16242527|NCT01065259|Drug|OROS MPH|The dosage began with 18mg Qd. It can be increased with 18mg every week until an optimal response achieved. The maximum dosage was no more than 54mg/d. The optimal dosage will maintain for 4 to 6 weeks
16242528|NCT01065259|Drug|Atomoxetine|The dosage begins with 0.5mg/kg.d. It can increased to 0.8mg/kg.d at the second week, 1.2mg/kg.d at the third week, and 1.4mg/kg.d at the 5th week according to the patients response. The optimal dosage will maintain for 4 to 6 weeks.
16242529|NCT01065246|Drug|catumaxomab|4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab
16242530|NCT01065233|Genetic|DNA extraction|DNA extraction of blood sample for DNAship analysis
16242531|NCT01065220|Drug|Testolactone undecanoate|4ml i.m.
16242532|NCT01065220|Drug|Lynestrenol|2/day
16242533|NCT01065220|Drug|Cyproterone Acetate|50mg per day
16242534|NCT01065220|Drug|Estradiol|100 microgram TTS twice a week
16242535|NCT01065220|Drug|5-alpha reductase inhibitor|1mg daily
16242536|NCT01065207|Biological|blood test at day one|"Epidemiological, clinical, virological, and immunological data will be collected.
~Clinical events as neoplasia will be collected"
16242537|NCT01065194|Drug|Levosimendan|Levosimendan will be infused on an outpatient basis for six hours at a dosage of 0,2 μg/kg/min without a bolus
16242538|NCT01065194|Drug|Placebo|Levosimendan will be infused on an outpatient basis for six hours at a dosage of 0,2 μg/kg/min without a bolus.
16242539|NCT01065142|Procedure|Therapeutic education|Improve therapeutic education efficiency on life quality of heart failure patients in general practice
16242540|NCT01065129|Drug|G-CSF|
16242541|NCT01065129|Drug|Plerixafor|
16242542|NCT01065129|Drug|Azacitidine|
16242543|NCT01065116|Drug|AL Blister-packs with Instruction leaflets|AL Blister packs with instruction leaflets will be dispensed
16242544|NCT01065116|Drug|AL unit dose age specific pre-packs|Age specific colour coded Unit dose pre-packs will be used
16242545|NCT01065103|Procedure|FFR (Fractional Flow Reserve)|Single FFR measurement in non-culprit vessel
16242546|NCT01065077|Drug|Cinaciguat (BAY58-2667)|Infusion of 150 µg/h during 48h
16242547|NCT01065077|Drug|Cinaciguat (BAY58-2667)|Infusion of 100 µg/h during 48h
16242548|NCT01065077|Drug|Cinaciguat (BAY58-2667)|Infusion of 50 µg/h during 48h
16242549|NCT01065077|Drug|Placebo|Infusion of placebo during 48h
16242590|NCT01064817|Drug|PRM-151|PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
16242550|NCT01065064|Procedure|RESTOR IOL|The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery
16242551|NCT01065051|Drug|Riociguat (Adempas, BAY63-2521)|1 mg single oral dose
16242552|NCT01065051|Drug|Placebo|Single oral dose
16242553|NCT01065038|Drug|Anagrelide|
16242554|NCT01065038|Drug|Hydroxyurea|
16242555|NCT01065025|Drug|4SC-205|Repeated ascending oral doses of 4SC-205.
16242556|NCT01065012|Drug|Udenafil 50 mg|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242557|NCT01065012|Drug|Udenafil 100 mg|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242558|NCT01065012|Drug|Udenafil 150 mg|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242559|NCT01065012|Drug|Placebo Matching 50 mg Udenafil|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242560|NCT01065012|Drug|Placebo Matching 100 mg Udenafil|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242561|NCT01065012|Drug|Placebo Matching 150 mg Udenafil|Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
16242562|NCT01064999|Drug|Oxaliplatin|CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
16242563|NCT01064999|Drug|Capecitabine|CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
16242564|NCT01064999|Radiation|Radiotherapy|High intensity group:55Gy Low intensity group:50Gy
16242565|NCT01064999|Procedure|Surgery|Lower anterior resection or abdominoperineal resection
16242566|NCT01064986|Biological|Endotoxin, Lipopolysaccharide, LPS|Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes)
16242567|NCT01064986|Biological|Endotoxin, Lipopolysaccharide, LPS /Epinephrine|Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)
16242568|NCT01064986|Biological|Placebo|Saline vehicle (placebo)
16242569|NCT01064986|Biological|Hydrocortisone|Hydrocortisone
16242570|NCT01064973|Drug|arbaclofen|A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the oral OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID
16242571|NCT01064960|Device|Philips MR-guided HIFU system|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
16242572|NCT01064947|Drug|Retapamulin 1%|Apply a thin layer of Retapamulin 1% to the affected area twice daily. The treated area may be covered with a sterile bandage or gauze dressing if desired.
16242573|NCT01064934|Procedure|Lipid apheresis|Weekly lipid apheresis procedure for lipoprotein(a) lowering
16242574|NCT01064934|Other|Standard care|Standard care for maximum cardiovascular risk reduction (behavioural, exercise, nutrition, drugs, etc.)
16242575|NCT01064921|Drug|vorinostat|The first vorinostat dose level is 100mg, and the second dose will be 200mg, third dose will be 300mg. If the first vorinostat dose level is found to be excessively toxic, the patient will be reduced to -1 dosing level then if still too toxic reduced again to dose level -2. Dose escalation of vorinostat will continue in increments of 100 mg (i.e., 200 mg on dosing days, 300 mg on dosing days). Vorinostat will be given 3 consecutive days per week (e.g. Monday, Tuesday, Wednesday).
16242576|NCT01064921|Drug|cisplatin|Given IV
16242577|NCT01064921|Radiation|radiation therapy|Standard chemoradiation therapy X 7 weeks (Days 7-56), concurrent with oral Vorinostat given three days per week (Mon, Tues, Wed)
16242578|NCT01064921|Procedure|Correlative Studies|Day 35, 2 weeks post radiation therapy completion optional tumor/normal muscosal biopsy and blood draw for correlative studies. At day 153 an optional tumor/normal tissue biopsy and blood draw for correlative studies.
16242579|NCT01064908|Device|OxyMask|Novel vortex oxygen delivery mask
16242580|NCT01064895|Device|Benephit catheter for Targeted Renal Therapy|Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system.
16242581|NCT01064882|Drug|bimatoprost ophthalmic solution 0.005%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
16242582|NCT01064882|Drug|bimatoprost ophthalmic solution 0.015%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
16242583|NCT01064882|Drug|bimatoprost ophthalmic solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
16242584|NCT01064869|Behavioral|Pyscho-behavioural|"A nurse-led programme of intervention will be devised. Patients will attend weekly for a period of 12 weeks. It will have two stages incorporating:
~1. Structured interview to identify demographic information and individual reasons for non-adherence and assessment of readiness to change behaviour
~This will be followed by an individualised package incorporating:
~A structured asthma education programme, to address any gaps in asthma knowledge or requests for information
~Motivational interviewing based on stages of change model to encourage change and adherence
~Psychological therapy involving (a) relaxation therapy (b) cognitive behavioural techniques looking at negative and catastrophic thoughts and (c) panic cycle adapted to respiratory patients"
16242585|NCT01064856|Biological|Adalimumab|Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.
16242591|NCT01064817|Drug|Placebo|Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
16242592|NCT01064804|Drug|PF-04191834|PF-04191834. 100mg Immediate Release Tablets or oral suspension
16242593|NCT01064791|Drug|sotrastaurin (Dose 1) + tacrolimus + standard of care medications|sotrastaurin (100mg bid) + tacrolimus + standard of care medications
16242594|NCT01064791|Drug|sotrastaurin (Dose 2) + tacrolimus + standard of care medications|sotrastaurin (200mg bid) + tacrolimus + standard of care medications
16242595|NCT01064791|Drug|sotrastaurin (Dose 3) + tacrolimus + standard of care medications|sotrastaurin (300mg bid) + tacrolimus + standard of care medications
16242596|NCT01064791|Drug|mycophenolic acid + tacrolimus + standard of care medications|mycophenolic acid (720mg bid) + tacrolimus + standard of care medications
16242597|NCT01064778|Other|Low GI|Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The low GI meal corn-starch as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.
16242598|NCT01064778|Other|High GI|Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The high GI meal contains corn-syrup as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.
16242599|NCT01064752|Drug|Minocycline|100 mg po bid for 8 weeks
16242600|NCT01064739|Dietary Supplement|Fava beans|Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet
16242601|NCT01064739|Other|Fixed Sodium Diet|Fixed sodium low monoamine diet
16242602|NCT01064726|Drug|Ibuprofen|800 mg oral
16242603|NCT01064726|Drug|Fluticasone propionate|200 mcg intra-nasal
16242604|NCT01064726|Drug|Placebo|Placebo
16242605|NCT01064713|Drug|Tesetaxel|"Cohort A: 40 mg by mouth every 21 days.
~Cohort B. 50 mg by mouth every 21 days."
16242606|NCT01064700|Device|Litebook Bright Light Box|Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.
16242607|NCT01064700|Device|Litebook inactivated negation ion generator (the placebo)|Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising
16242608|NCT01064687|Drug|LY2189265|
16242609|NCT01064687|Drug|Exenatide|
16242610|NCT01064687|Drug|Placebo|
16242611|NCT01064687|Drug|Metformin|
16242612|NCT01064687|Drug|Pioglitazone|
16242613|NCT01064674|Other|diagnostic procedure|Cardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy.
16242614|NCT01064661|Dietary Supplement|Single probiotic arm of L-NCFM alone|Single probiotic of L-NCFM alone pills BID (2x10^10 cfu total bacteria per day)
16242615|NCT01064661|Dietary Supplement|Blend probiotic arm of L-NCFM and B-LBi07|Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10^10 cfu total bacteria per day)
16242616|NCT01064648|Drug|Cediranib Maleate|Given orally
16242617|NCT01064648|Drug|Cisplatin|Given IV
16242618|NCT01064648|Other|Laboratory Biomarker Analysis|Correlative studies
16242619|NCT01064648|Drug|Pemetrexed Disodium|Given IV
16242620|NCT01064648|Other|Placebo Administration|Given orally
16242621|NCT01064635|Drug|Letrozole|letrozole for 2-3 years after Tam
16242622|NCT01064635|Drug|Letrozole|Letrozole for 5 years after Tam
16242623|NCT01064622|Drug|vismodegib|Given PO
16242624|NCT01064622|Drug|gemcitabine hydrochloride|Given IV
16242625|NCT01064622|Other|hydrocortisone/placebo|Given PO
16242626|NCT01064609|Procedure|Biopsy by cryoprobes|Transbronchial lung biopsy with cryoprobes.
16242627|NCT01064609|Procedure|Biopsy with conventional forceps|Transbronchial lung biopsy with conventional forceps.
16242628|NCT01064596|Other|blood samples|patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery
16242629|NCT01064583|Other|cocoa|dissolved in water twice-daily intervention
16242630|NCT01064570|Drug|all-trans retinoic acid (ATRA)|
16242631|NCT01064557|Drug|all-trans retinoic acid (ATRA)|
16242632|NCT01064544|Procedure|light therapy with the device: EnergyLight|2 hr of light therapy during each hemodialysis session
16242633|NCT01064531|Device|MIS Femoral Neck Stem implant|
16242634|NCT01064518|Drug|Botulinum Toxin Type A|RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines
16242635|NCT01064518|Drug|Placebo (Dose B)|Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines
16242636|NCT01064505|Drug|QPI-1007 at various doses|Single Intravitreal Injection
16242637|NCT01064492|Drug|PF-04620110|The three treatments are A) a single dose of 5 mg PIC under fasted condition; B) a single dose of 5 mg tablet under fasted condition: and C) a single dose of 5 mg tablet under fed condition.
16242638|NCT01064479|Drug|Carboplatin|Given IV
16242639|NCT01064479|Drug|Cisplatin|Given IV
16242640|NCT01064479|Drug|Docetaxel|Given IV
16242641|NCT01064479|Drug|Erlotinib Hydrochloride|Given PO
16242642|NCT01064479|Other|Laboratory Biomarker Analysis|Optional correlative studies
16242643|NCT01064479|Other|Pharmacological Study|Optional correlative studies
16242644|NCT01064479|Other|Placebo|Given PO
16242645|NCT01064479|Other|Quality-of-Life Assessment|Ancillary studies
16243321|NCT01059188|Drug|cisplatin|50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles
16242646|NCT01064466|Drug|ETOPOSIDE - Usual|Etoposide Injection plus Methotrexate Injection plus Topotecan Injection
16242647|NCT01064466|Drug|ETOPOSIDE - Study|Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule
16242648|NCT01064453|Drug|E2/DRSP (Angeliq, BAY86-4891)|Take one tablet daily, continuously
16242649|NCT01064440|Biological|Low Dose VM202|Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
16242650|NCT01064440|Biological|High Dose VM202|Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 42: 4mg of VM202 (16 injections of 0.5ml of VM202)
16242651|NCT01064440|Other|Placebo|Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
16242652|NCT01064414|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
16242653|NCT01064414|Drug|Placebo|One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
16242654|NCT01064401|Biological|BIIB019 (Daclizumab High Yield Process)|Daclizumab High Yield Process for subcutaneous injection
16242655|NCT01064401|Drug|Interferon beta-1a Placebo|Placebo to interferon beta-1a intramuscular injection
16242656|NCT01064401|Biological|Interferon beta-1a|Interferon beta-1a for intramuscular injection
16242657|NCT01064401|Drug|Daclizumab High Yield Process Placebo|Placebo to Daclizumab High Yield Process subcutaneous injection
16242658|NCT01064388|Drug|AZD9742|IV infusion, 15 days
16242659|NCT01064388|Drug|Placebo|IV infusion, 15 days
16242660|NCT01064375|Biological|tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)|Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation
16242661|NCT01064375|Device|Derma Vax (electroporation device)|Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration
16242662|NCT01064375|Biological|GM-CSF|GM-CSF will be given for 4 consecutive days starting the day before the vaccination as an intradermal/subcutaneous administration of 150 ug of GM-CSF
16242663|NCT01064375|Drug|Cyclophosphamide|One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA
16242664|NCT01064362|Drug|Fondaparinux sodium|Fondaparinux sodium for thromboprophylaxis (ATC: B01AX05)
16242665|NCT01064362|Drug|Low molecular weight heparin (LMWH)|LMWH including: dalteparin, nadroparin, enoxaparin or tinzaparin (ATC:B01AB (excluding B01AB01))
16242666|NCT01064349|Drug|Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer|Trastuzumab or Lapatinib
16242667|NCT01064336|Drug|Eltrombopag|Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura
16242668|NCT01064323|Device|Intermittent pneumatic compression of the lower extremities|IPC will be done for 3 divided hours daily for 4 weeks
16242669|NCT01064310|Drug|pazopanib|oral anti-angiogenic treatment
16242670|NCT01064310|Drug|sunitinib|oral anti-angiogenic treatment
16242671|NCT01064297|Drug|Lamotrigine monotherapy|Lamotrigine monotherapy
16242672|NCT01064297|Drug|Lamotrigine polytherapy including valproate|Lamotrigine polytherapy including valproate
16242673|NCT01064297|Drug|Lamotrigine polytherapy without valproate|Lamotrigine polytherapy without valproate
16242674|NCT01064284|Drug|PLASMA DERIVED Factor VIII|Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding
16242675|NCT01064284|Drug|Recombinant FVIII|Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding
16242676|NCT01064271|Drug|Risperidone|Risperidone Tablets 1 mg
16242677|NCT01064258|Device|CPAP|CPAP at 4 cm H2O
16242678|NCT01064258|Device|autoCPAP|autoCPAP working between 4 and 15 cm H2O
16242679|NCT01064245|Drug|high-dose methacholine challenge test|nebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses
16242680|NCT01064245|Other|mannitol challenge test|inhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg
16242681|NCT01064232|Drug|Risperidone|Risperidone Tablets 1 mg
16242682|NCT01064219|Drug|human chorionic gonadotrophin|intrauterine injection of 100 IU hCG followed by endometrial biopsy .
16242683|NCT01064193|Procedure|biopsy|"The endometrium biopsy will be done as the same time as the GnRH treatment. The biopsy is realised with a Pipette de Cornier® (CDD international, PROMIDED France) following the laboratory protocol:
~Apply antiseptic solution (povidone-iodine, Dakin®) on the cervix and vagina. In most cases, using Pozzi forceps is not necessary.
~Insert carefully the pipelle de Cornier® in the uterus through the cervix.
~Withdraw the piston to create a negative pression
~Move the pipelle de cornier® in and out while twisting. Take care to no remove the pipelle form the uterus (suction lost). Twist the pipelle de Cornier® to cover an angle of 360°. Make several in and out cycle in order to collect a complete sample of the endometrium.
~Withdraw the pipelle de Cornier® when filled with tissue
~Reinsert internal piston to deposit sample in cup filled with a fixative."
16242684|NCT01064193|Procedure|IVF|fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation
16242685|NCT01064180|Drug|Carvedilol|Carvedilol Tablets 25 mg
16242686|NCT01064167|Drug|Tranexamic Acid|In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.
16242687|NCT01064154|Drug|Carvedilol|Carvedilol Tablets 25 mg
16242688|NCT01064141|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus|0.5 mL, Subcutaneous
16242689|NCT01064141|Biological|OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines|0.5 mL, Subcutaneous and 0.5 mL, Intravascular
16242690|NCT01064141|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines|0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
16242691|NCT01064141|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)|0.5 mL Subcutaneous and 0.5 mL Subcutaneous
16242692|NCT01064128|Procedure|conventional laparoscopic hysterectomy|conventional 3 or 4 ports laparoscopic hysterectomy
16242693|NCT01064128|Procedure|SPA laparoscopic hysterectomy|single-port access laparoscopic hysterectomy
16242694|NCT01064115|Drug|Cetirizine Hydrochloride|Cetirizine Hydrochloride Tablets 10 mg
16242695|NCT01064102|Drug|Cetirizine Hydrochloride|Cetirizine Hydrochloride Tablets 10 mg
16242696|NCT01064089|Drug|HSP990|
16242697|NCT01064076|Device|S-ICD System|The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).
16242698|NCT01064063|Device|Vanguard CR|The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.
16242699|NCT01064063|Device|AGC knee|The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
16242700|NCT01064050|Device|silicone trachea-bronchial stent Dumon (Novatech)|Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area
16242701|NCT01064037|Drug|Cinaciguat (BAY58-2667)|Infusion of 150 µg/h during 48h.
16242702|NCT01064037|Drug|Cinaciguat (BAY58-2667)|Infusion of 100 µg/h during 48h
16242703|NCT01064037|Drug|Cinaciguat (BAY58-2667)|Infusion of 50 µg/h during 48h
16242704|NCT01064037|Drug|Placebo|Infusion during 48h
16242705|NCT01064024|Drug|Phenazopyridine Hydrochloride|Tablets, 200 mg, every 8 hours for 48 hours.
16242706|NCT01064024|Drug|Placebo|Tablets, every 8 hours for 48 hours
16242707|NCT01064011|Procedure|Rt-PA thrombolysis|patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.
16242708|NCT01064011|Procedure|endoscopic hematoma evacuation|In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.
16242709|NCT01063998|Other|Urine Marker|Urinary KIM-1 measurements
16242710|NCT01063972|Behavioral|Centralized disease management (CDM)|Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider
16242711|NCT01063972|Behavioral|Counseling (C)|Counseling (C) arm will receive counseling without the care coordination services.
16242712|NCT01063959|Procedure|Laparoscopic Sleeve Gastrectomy|Sleeve Gastrectomy was originally reported as the first step in an alternative two-staged procedure for the super obese patient to decrease morbidity, predominantly private pay.
16242713|NCT01063959|Procedure|Laparoscopic Gastric Bypass|Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.
16242714|NCT01063946|Drug|Ombrabulin (AVE8062)|"Pharmaceutical form:concentrate solution
~Route of administration: intravenous infusion"
16242715|NCT01063933|Drug|Peramivir|Peramivir is a liquid for parenteral administration. Cohort I: Peramivir, 10 mg/kg intravenously (IV) every day (QD) (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Cohort II: Peramivir 12 mg/kg IV QD (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Cohort III: Peramivir 16 mg/kg QD (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Proposed doses for subjects in Cohorts IV, V, VI, and VII are 18, 18, 14 and 12 mg/kg, respectively, IV, QD for 5 days or until hospital discharge, whichever comes first. IV peramivir will be administered over 60 minutes.
16242716|NCT01063920|Drug|LT-NS001|1200 mg b.i.d. p.o. for 12 weeks
16242717|NCT01063920|Drug|Naprosyn®|500 mg b.i.d. p.o. for 12 weeks
16242718|NCT01063907|Drug|KW-2478|Administered Days 1, 4, 8 and 11 of a 21 day cycle
16242719|NCT01063907|Drug|Bortezomib|Administered on Days 1, 4, 8 and 11 of a 21 day cycle
16242720|NCT01063894|Other|breakfast cereal|breakfast cereal and milk
16242721|NCT01063894|Other|water|water
16242722|NCT01063881|Drug|Dapoxetine|Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
16242723|NCT01063868|Drug|Tapentadol extended release (ER)|100, 150, 200, 250 mg twice daily for 52 weeks
16242724|NCT01063868|Drug|Oxycodone controlled release (CR)|20, 30, 40, 50 mg twice daily for 52 weeks
16242725|NCT01063855|Drug|Placebo|Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.
16242726|NCT01063855|Drug|Dapoxetine|30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.
16242727|NCT01063855|Drug|PDE5I (phosphodiesterase-5 inhibitor)|Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.
16242728|NCT01063842|Drug|tramadol hydrochloride /acetaminophen|1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.
16242729|NCT01063842|Drug|tramadol hydrochloride / acetaminophen and placebo|1 tablet of tramadol/acetaminophen in the morning, 1 tablet of placebo in the afternoon and evening for 3 days, then 1 tablet of tramadol/acetaminophen in the morning, evening and 1 tablet of placebo in the afternoon for 4 days, then 1 tablet of tramadol/acetaminophen 3 times daily for next 7 days
16242730|NCT01063829|Drug|60 mg AIC246|Oral administration
16242731|NCT01063829|Drug|120 mg AIC246|Oral administration
16242732|NCT01063829|Drug|240 mg AIC246|Oral administration
16242733|NCT01063829|Other|Placebo|Oral administration
16242734|NCT01063816|Drug|veliparib (ABT-888)|Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.
16242735|NCT01063816|Drug|carboplatin|Carboplatin will be dosed on Day 1 of each cycle, intravenously.
16242736|NCT01063816|Drug|gemcitabine|Dosing on Days 1 and 8 of each Cycle, intravenously.
16242737|NCT01063803|Drug|ATN-103|A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
16242738|NCT01063803|Drug|ATN-103|A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
16242739|NCT01063790|Behavioral|Individualized Education|The intervention consists of written information in the form of a booklet, an individualized face to face education session and two telephone support calls regarding post-discharge pain management, adverse effects of analgesics and common concerns about asking for help with pain.Participants in the intervention group will also receive two telephone support calls. The purpose of the telephone support calls is to readdress the information that patients received in the booklet and to clarify concerns regarding post-operative pain management that were discussed during the individualized education session.
16242740|NCT01063777|Other|A 12 week exercise therapy program and patient education.|"The exercise protocol includes exercises from former studies on comparable patient populations. The intensity of the strength- and flexibility exercises meets the American College of Sports Medicine's (ACSM) recommendations for developing and maintaining muscular fitness in adults.Patients will be required to exercise for 60 minutes, three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) will be registered by the physical therapists.
~All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time."
16242741|NCT01063777|Other|Patient education|All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.
16242742|NCT01063764|Drug|Levetiracetam|"First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted."
16242744|NCT01063738|Dietary Supplement|Amino acid supplement|Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months
16242745|NCT01063738|Other|PEPSE|Enhanced physiotherapy programme of 3 1 hour sessions per week for 6 weeks while in hospital and once discharged home 1 supervised outpatient session of 1 hour and 2 home exercise sessions per week (PEPSE).
16242746|NCT01063738|Other|Intensive Care Unit (ICU) Recovery Manual|Standard self-directed 6 week rehabilitation package
16242747|NCT01063738|Dietary Supplement|Placebo nutritional supplement|Cherry flavoured low calorie and low protein placebo drink
16242748|NCT01063725|Dietary Supplement|Femarelle|A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
16242749|NCT01063725|Other|Placebo|Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
16242750|NCT01063712|Device|Nit-Occlud® PDA-R|"Transcatheter implantation of a PDA Device (Nitinol) The catheterism was done under sedation, using a protocol established by inserting a catheter through a femoral artery and/or vein directed to the heart and great vessels. Invasive measurements are obtained in the descending aorta and pulmonary artery. Once in ductal position, we inject iodinated contrast medium that allows us to observe via X-ray the ductal morphology; obtaining accurate measurements to choose the appropriate device. The device is then inserted via the catheter, closing the ductus.
~The catheterism provides measures of aortic and pulmonary pressure, before, during and after the closure."
16242751|NCT01063699|Procedure|Laparoscopic Kasai operation|the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
16242752|NCT01063686|Device|insemination cervical cap|Primary abdominal ultrasound (US) for amniotic fluid index (AFI), Single vertical pocket, and dimensions of pocket below the presenting part. Speculum vaginal examination. In a sterile manner a cervical cap is adjusted on the cervix. the patient is kept recumbent for 6 hours. A repeat US exam is performed. The cervical cap is removed. After one hour another US is performed.
16242753|NCT01063660|Drug|Treosulfan|14 g/m²/d day -6 to -4
16242754|NCT01063647|Drug|Treosulfan|10 g/m² i.v. infusion, day -6, -5, -4
16242755|NCT01063647|Drug|Treosulfan|12 g/m² i.v. infusion, day -6, -5, -4
16242756|NCT01063647|Drug|Treosulfan|14 g/m² i.v. infusion, day -6, -5, -4
16242757|NCT01063621|Drug|KW-6500|Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks
16242758|NCT01063608|Biological|Anti-H1N1v Vaccine|Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.
16242759|NCT01063595|Biological|Octaplas LG|Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags.
16242760|NCT01063595|Biological|Octaplas SD|Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags.
16242761|NCT01063582|Other|exposure to occupational noise|We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
16242762|NCT01063582|Procedure|cardiovascular valuation|Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
16242763|NCT01063569|Drug|Solu-Cortef (hydrocortisone)|Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
16242764|NCT01063569|Drug|Cortef (hydrocortisone)|Oral treatment 3 times a day. Weight adjusted doses.
16242765|NCT01063556|Drug|donepezil HCl|Subjects will receive donepezil HCL 3 mg without haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg with haemodialysis.
16242766|NCT01063556|Drug|donepezil HCl|Subjects will receive donepezil HCl 3 mg with haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg without haemodialysis.
16242767|NCT01063530|Device|DIammine SIlver fluoride|Application of Diammine SIlver Fluoride in cervical lesions
16242768|NCT01063530|Device|DIstilled water|Application of distilled water in cervical lesions
16242772|NCT01063504|Drug|teriparatide|
16242773|NCT01063491|Procedure|bypass graft angiography|
16242774|NCT01063478|Drug|RAD001 (in addition to standard radiation and chemotherapy)|Standard radiation and chemotherapy (cisplatin and pemetrexed) + RAD001
16242775|NCT01063465|Device|Early weightbearing|Patients in the intervention group are after 2 weeks supposed to remove the cast twice a day and use a special training pedal for 5 weeks (until cast removal).
16242776|NCT01063452|Device|Truvalve|Atkinson Product Design urinary slide valve
16242777|NCT01063452|Other|Control (catheter drainage bag)|urinary catheter drainage bag
16242778|NCT01063439|Drug|Busulfan, Etoposide, Cytarabine, Melphalan|Busulfan 3.2 mg/kg/d for 2 days Etoposide 400 mg/m2/d for 2days Cytarabine 1 g/m2 for 2 days Melphalan 140 mg/m2 for 1 day
16242779|NCT01063426|Drug|High dose Atorvastatin+enoxaparin|High dose atorvastatin 80mg/day for 7days after index surgery (total knee replacement arthroplasty, TKRA). At the same time Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered.
16242780|NCT01063426|Drug|Enoxaparin|Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
16242781|NCT01063400|Other|Observation|monitoring of physical activity for 14 days using physical activity monitoring devices along with activity diary
16242782|NCT01063387|Radiation|Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer|Sema4c positive+ Para-aortic lymph node metastasis Experimental : Radiation: Extended-field Irradiation (EFI) Prophylactic irradiation of supraclavicular lymph node
16242783|NCT01063387|Radiation|Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer|Sema4c positive +Common iliac lymph nodes metastasis Experimental :Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation)
16242784|NCT01063374|Dietary Supplement|low glycemic diet instruction|
16242785|NCT01063374|Dietary Supplement|high cereal fibre diet instruction|
16242786|NCT01063361|Dietary Supplement|Low glycemic index diet with pulses|Subjects will be advised to follow a diabetic diet, using low glycemic index foods, emphasizing pulses.
16242787|NCT01063361|Dietary Supplement|High Cereal Fibre|Subjects will be advised to follow a healthy high fibre diabetic diet.
16242788|NCT01063348|Drug|N-Acetyl Cysteine|Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)
16242789|NCT01063348|Drug|Placebo|Matching placebo capsules taken in same amount of pills as the active medication.
16242790|NCT01063283|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 intravenously over 10 minutes
16242791|NCT01063283|Drug|Carboplatin|Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes
16242792|NCT01063283|Drug|Bevacizumab 7.5 mg/kg|Bevacizumab at 7.5 mg/kg intravenously over 90 minutes
16242793|NCT01063283|Drug|Bevacizumab 15 mg/kg|Bevacizumab at 15 mg/kg intravenously over 90 minutes
16242794|NCT01063270|Drug|Clindamycin & Rifampin|Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks
16242795|NCT01063270|Procedure|Clindamycin + Rifampin along with NdYag Laser treatment|Clindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions.
16242796|NCT01063257|Drug|Clofarabine|"The dosage of Clofarabine will be gradually augmented in a 3+3 design for each following dose level:
~DL1 - 5mg/m2/d, DL2 - 7.5mg/m2/d, DL3 - 10mg/m2/d, DL4 - 12.5mg/m2/d (This dose may not be reached and is an optional dose level in case the MTD is not reached before and depending on further data from the ongoing MDS Phase IIa oral formulation trial).
~The DLa will be the following:
~DL1a - 2.5mg/m2/d, DL2a - 6.5mg/m2/d, DL3a - 8.5mg/m2/d, DL4a - 11.5mg/m2/d (In case of activation of the DL4 step). Dose levels 1a, 2a and 3a will be used for de-escalation."
16242797|NCT01063244|Device|foley balloon only|place foley balloon only in cervix
16242798|NCT01063244|Device|foley balloon with weight attached|foley balloon with 1000cc IV bag attached
16242799|NCT01063231|Device|PillCam™ (Capsule Endoscopy) Colon 2 capsule|Medical Device
16242800|NCT01063218|Other|Emollient - Cetaphil Advanced|Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
16242801|NCT01063205|Drug|Placebo|Placebo administration will be started on day 2 and stopped on day 5. Methylsulonylmethane (MSM) will serve as a placebo for MA.
16242802|NCT01063205|Drug|N-acetylcysteine|Study medication (NAC 1800 mg) will be started on day 2 and stopped on day 5.
16242803|NCT01063205|Drug|N-acetylcysteine|Study medication (NAC 3600 mg) will be started on day 2 and stopped on day 5.
16242804|NCT01063192|Drug|Gemcitabine|Arm 1: Gemcitabine alone on D1,8,15 every 28 days for 3 cycles
16242805|NCT01063192|Drug|Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)|Arm 2: GOFL on D1, 15 every 28 days for 3 cycles(Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr)
16242806|NCT01063179|Drug|Bortezomib, Melphalan, Prednisone, Thalidomide|"Induction therapy:
~9 courses with weekly VELCADE (4 doses) in combination with oral Melphalan 9 mg/m2,oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course and Thalidomide 50 mg/day continuously. The dose of VELCADE is 1.3 mg/m2 administered as a bolus IV injection, on days 1, 8, 15, 22.
~Maintenance therapy:
~Thalidomide 50 mg/day continuously in combination with VELCADE 1.3 mg or maximum dose tolerated/m2/2 weeks. The maintenance will be initiated at the end of the 9th course and will be stopped after progression. The median expected duration of the maintenance treatment is approximately 2 years."
16242807|NCT01063179|Drug|Bortezomib, Melphalan, Prednisone|Induction therapy: 9 courses with weekly VELCADE(4 doses) in combination with oral Melphalan 9 mg/m2 and oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course. No maintenance therapy is scheduled
16242920|NCT01062334|Procedure|Peritoneal Microdialysis, CT-scan, leakage scoring|Peritoneal microdialysis CT-scan before discharge Leakage scoring daily
16242808|NCT01063153|Drug|Osmotic Release Methylphenidate|During a 6 week treatment period, adult subjects with ADHD are prescribed, in an open label fashion, once daily doses of osmotic release methylphenidate to a maximum daily dose of 144 mg. Efficacy and tolerability assessments are completed, in addition to EEG and cognitive testing. Healthy adults without ADHD will not receive medication.
16242809|NCT01063140|Biological|Rabies Vaccine (RabAvert)|The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period.
16242810|NCT01063140|Biological|Rabies Vaccine (Imovax)|The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period.
16242811|NCT01063127|Other|Study on insulin sensitivity after diet or bariatric surgery|Group A: 1 week of low calorie diet before gastric banding a new study 1 week after gastric banding Group B: 1 week of low calorie diet before gastric bypass a new study 1 week after gastric bypass
16242812|NCT01063127|Other|gastric bypass|Group B: 1 week of low calorie diet before gastric bypass a new study 1 week after gastric bypass
16242813|NCT01063114|Radiation|proton beam radiation|Given once a day, 5 days a week (Monday-Friday)
16242814|NCT01063101|Other|Fucoidan (extract of Laminaria japonica)|Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID
16242815|NCT01063101|Other|Placebo|Cellulose filled capsule - oral administration - 5 different dose levels - BID
16242816|NCT01063088|Biological|Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures)|Single 0.5 mL intramuscular injection
16242817|NCT01063075|Drug|Cetuximab|Administered Intravenously
16242818|NCT01063075|Drug|Carboplatin|Administered Intravenously
16242819|NCT01063075|Drug|5 - FU|Administered Intravenously
16242820|NCT01063062|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenous infusion every 4 weeks.
16242821|NCT01063062|Drug|Methotrexate|methotrexate as per standard of care in clinical practice.
16242822|NCT01063049|Drug|Gatorade/Miralax|Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
16242823|NCT01063049|Drug|NuLytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
16242824|NCT01063049|Drug|Bisacodyl|Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.
16242825|NCT01063049|Drug|Placebo|Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
16242826|NCT01063036|Drug|Entecavir|Tablets, Oral, 1 mg, once daily, 96 weeks
16242827|NCT01063036|Drug|Tenofovir|Tablets, Oral, 300 mg, once daily, 96 weeks
16242828|NCT01063023|Drug|Ortho Tri-Cyclen®|Tablets, Oral, 1 Tablet, once daily
16242829|NCT01063023|Drug|BMS-650032|Tablets, Oral, 600 mg, BID
16242830|NCT01063010|Drug|Bevacizumab|Administered intravenously 10 mg/kg over 90 minutes (+ 15 minutes)
16242831|NCT01063010|Drug|Placebo|Placebo administered intravenously for 90 minutes (+ 15 minutes)
16242832|NCT01062984|Procedure|Continuous Venovenous Hemofiltration (CVVH)|The NxStage system will be used for CVVH using the NxStage Cartridge Express dialyzer (polyethersulfone membrane). The blood flow rate will be set at 250 cc/min, and decreased at the discretion of the primary nephrologist's assessment of filter pressures and alarms. Replacement fluid will be delivered pre-filter for CVVH; the target effluent flow rate will be 35ml/kg/hr plus desired ultrafiltration (fluid removal). A maximum of 4.5 L/hr effluent will be prescribed to obese or hypercatabolic patients.
16242833|NCT01062984|Procedure|Continuous Venovenous Hemodialysis (CVVHD)|The NxStage system will be used for CVVH and CVVHD using the NxStage Cartridge Express dialyzer (polyethersulfone membrane). The blood flow rate will be set at 250 cc/min, and decreased at the discretion of the primary nephrologist's assessment of filter pressures and alarms. Replacement fluid dialysate will be infused countercurrent to blood flow the target effluent flow rate will be 35ml/kg/hr plus desired ultrafiltration (fluid removal). A maximum of 4.5 L/hr effluent will be prescribed to obese or hypercatabolic patients.
16242834|NCT01062971|Drug|dorzolamide-timolol-brimonidine|Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.
16242835|NCT01062958|Other|Neevo® (a medical food)|
16242836|NCT01062958|Other|Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)|
16242837|NCT01062945|Drug|Placebo|Matching administration of a placebo pill.
16242838|NCT01062945|Drug|Doxazosin|The dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12.
16242839|NCT01062932|Drug|Cycloserine|Oral administration of cycloserine medication (50 mg administered prior to each exposure treatment) on Day 1, 4, 7, and 10 of the study
16242840|NCT01062932|Drug|Placebo|Oral administration of matching placebo pill on Days 1, 4, 7, and 10
16242841|NCT01062919|Procedure|Epidural analgesia|patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.
16242842|NCT01062919|Procedure|Wound catheter|patients in the epidural analgesia group will receive 0.2%ropivacaine through the wound catheter, normal saline in the epidural catheter and PCA with morphine.
16242843|NCT01062906|Drug|Lidocaine|1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)
16242844|NCT01062906|Drug|Fentanyl|Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)
16242963|NCT01061905|Behavioral|Exercise Equivalent only|Posting of only exercise equivalents (e.g. 45 minutes on a treadmill) for both sugar-sweetened and zero-calorie beverages, prominently on a poster.
16242845|NCT01062893|Other|Sterile normal saline 0 mls|at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.
16242846|NCT01062893|Other|15 mls sterile normal saline|After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.
16242847|NCT01062880|Behavioral|self-guided internet modules|Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.
16242848|NCT01062867|Drug|ORG25435|Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg by intravenous infusion over 1 min Up to 25mg/kg by infusion over 30min
16242849|NCT01062854|Other|Soft earplugs are worn during sleep study|"Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either wears earplugs or no earplugs groups."
16242850|NCT01062841|Behavioral|Targeted Infection Control|"Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
16242851|NCT01062828|Diagnostic Test|Citrulline samples|Citrulline samples will be collected at the time of other lab work twice a week from enrollment until 40 weeks postconceptional age and once a week until 44 weeks postconceptional age (1 month corrected age) OR discharge from NICU(whichever is soonest). In subgroup developing NEC, citrulline samples will be collected twice a week from enrollment until discharge from NICU or death.
16242852|NCT01062815|Dietary Supplement|Parenteral Nutrition|Parenteral Nutrition infused over 20 hours cycled with dextrose solution over 4 hours compared to Parenteral Nutrition infused continuously over 24 hours.
16242853|NCT01062802|Drug|Atorvastatin|Atorvastatin 80mg, once a day for four weeks.
16242854|NCT01062802|Other|Placebo|Placebo given once daily for 4 weeks.
16242855|NCT01062789|Device|Optical breath-hold control system (OBC)|The OBC system was designed to replace the IBC rubber bellows respiration sensor system that we are currently using for CT-guided lung biopsies. Unlike the IBC, the OBC is 1) unaffected by temperature changes, 2) has a linear sensitivity (for easier use and better accuracy), 3) has no pneumatic purge time when setting reference breath-hold level (reducing the chance of an inappropriate reference), 4) has no pneumatic cable that can occasionally interfere and get pinched during procedures, 5) is ambulatory (so patients can more easily familiarize themselves with the device before the procedure), 6) is capable of indicating proper fitting tension, 7) allows for easier binding (wireless pairing with other system components), and 8) is significantly less expensive (and possibly disposable).
16242856|NCT01062776|Biological|Dehydration|Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.
16242857|NCT01062776|Biological|Placebo|No dehydration is induced
16242858|NCT01062763|Drug|spironolactone|25 to 50 mg once daily
16242859|NCT01062763|Drug|placebo|addition of placebo 1 to 2 tablets daily
16242860|NCT01062750|Biological|adipose tissue derived stromal cells dosage|single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization
16242861|NCT01062737|Drug|ASU|
16242862|NCT01062724|Other|Primene 10 % from Baxter|Primene solution will be calculated in g/kg/day and administered in ml/day Active Comparator: Trophamine This group of neonates will be receive the Trophamine amino acid solution from Pisa laboratories and the other arm will be receive a Primene amino acid solution (10 %) from Baxter laboratories. For infants identified, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat and daily enteral intake (ml/kg/d) of breast milk or formula will be record.
16242863|NCT01062711|Dietary Supplement|Whey or soy protein|Whey and casein are isolated milk proteins
16242864|NCT01062698|Drug|Alteplase (rt-PA)/Actilyse|Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.
16242865|NCT01062698|Procedure|Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)|Mechanic thrombectomy
16242866|NCT01062685|Diagnostic Test|Near-infrared spectroscopy assessment|"The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements.
~Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes."
16242867|NCT01062646|Behavioral|Multimodal music therapy|
16242868|NCT01062646|Behavioral|Community treatment as usual|
16242869|NCT01062633|Dietary Supplement|A, erythritol|2,5 g 3 times a day
16242870|NCT01062633|Dietary Supplement|xylitol|2,5 g 3 times a day
16242871|NCT01062633|Dietary Supplement|C, sorbitol|2,5 g 3 times aday
16242872|NCT01062620|Drug|AXL1717|Phase I study with increasing dosage and treatment duration
16242873|NCT01062594|Other|Supervised exercise|Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
16242874|NCT01062594|Other|Role of exercise|Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
16242875|NCT01062594|Other|Supervised exercise program|Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
16242876|NCT01062568|Drug|Adrenocorticotropin|Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
16243096|NCT01060969|Drug|Acetazolamide|Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude
16242877|NCT01062568|Drug|Dexamethasone|Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
16242878|NCT01062555|Drug|Cyclosporine & Cellcept|Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
16242879|NCT01062555|Drug|Prograf & Cellcept|Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
16242880|NCT01062555|Drug|Low Dose CNI (Cyclosporine or FK) and Cellcept|Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
16242881|NCT01062555|Drug|Rapamune and Cellcept|Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
16242882|NCT01062542|Procedure|Blood Draw and Ultrasound|Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately.
16242883|NCT01062529|Drug|Somatostatin|4 h of 150 microgram infusion
16242884|NCT01062516|Drug|esomeprazole 20 mg daily|oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
16242885|NCT01062516|Drug|famotidine 40 mg daily|oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
16242886|NCT01062503|Drug|Zoledronic acid|ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
16242887|NCT01062490|Drug|Treosulfan|14 g/m2/d, day -6 to -4
16242888|NCT01062477|Biological|DTaP//PRP-T Combined Vaccine|0.5 mL, Intramuscular
16242889|NCT01062477|Biological|DTaP//PRP-T Combined Vaccine|0.5 mL, Intramuscular
16242890|NCT01062477|Biological|DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine|0.5 mL, Intramuscular (each vaccine)
16242891|NCT01062451|Drug|Perindopril|8 mg taken orally from days 0 through 7.
16242892|NCT01062451|Drug|Placebo|Placebo treatment daily.
16242893|NCT01062451|Drug|Candesartan|16 mg taken orally from days 0 through 7.
16242894|NCT01062438|Genetic|DNA analysis|
16242895|NCT01062438|Genetic|RNA analysis|
16242896|NCT01062438|Genetic|gene expression analysis|
16242897|NCT01062438|Genetic|gene rearrangement analysis|
16242898|NCT01062438|Genetic|mutation analysis|
16242899|NCT01062438|Other|laboratory biomarker analysis|
16242900|NCT01062425|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-dimensional conformal radiotherapy
16242901|NCT01062425|Drug|Cediranib Maleate|Given PO
16242902|NCT01062425|Radiation|Intensity-Modulated Radiation Therapy|Undergo intensity-modulated radiation therapy
16242903|NCT01062425|Other|Laboratory Biomarker Analysis|Correlative studies
16242904|NCT01062425|Other|Placebo Administration|Given PO
16242905|NCT01062425|Drug|Temozolomide|Given PO
16242906|NCT01062399|Drug|concurrent RAD001 10 mg/day|During radiation: RAD001 10 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
16242907|NCT01062399|Drug|concurrent temozolomide|During radiation: temozolomide 75 mg/m2/day orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42. Dose rounded to the nearest 5 mg.
16242908|NCT01062399|Radiation|Radiation therapy|Intensity Modulated RT (IMRT) allowed. For both IMRT and 3D conformal radiotherapy (3D-CRT) plans, one treatment of 2 Gy given daily 5 days per week for a total of 60 Gy over 6 weeks.
16242909|NCT01062399|Drug|concurrent RAD001 2.5 mg/day|During radiation: RAD001 2.5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
16242910|NCT01062399|Drug|concurrent RAD001 5 mg/day|During radiation: RAD001 5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.
16242911|NCT01062399|Drug|post-radiation RAD001 10 mg/day|Post-radiation: RAD001 10 mg orally daily on days 1-28 of each cycle, for up to 12 cycles, starting 28 days after the completion of radiation therapy (Cycle = 28 days).
16242912|NCT01062399|Drug|post-radiation temozolomide|Post-radiation: temozolomide 150 mg/m2/day - 200 mg/m2/day orally daily on days 1-5 of each cycle, starting 28 days after the completion of radiation therapy for up to 12 cycles (Cycle = 28 days)
16242913|NCT01062373|Dietary Supplement|Supplementation of lactating mothers who has delivered prematurely with DHA|Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)
16242914|NCT01062373|Dietary Supplement|Supplementation of lactating mothers who has delivered prematurely with DHA|Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day)
16242915|NCT01062360|Drug|Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine|Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
16242916|NCT01062360|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
16242917|NCT01062360|Drug|Pseudoephedrine|Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
16242918|NCT01062360|Drug|Placebo|Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
16242919|NCT01062347|Biological|Zinc|
16242921|NCT01062308|Procedure|Taping and Sham Taping|"Taping shoulder with Hospiplast tape.
~Taping the shoulder after acute stroke to prevent shoulder injury and pain.
~Taping the shoulder after acute stroke and compare with sham taping group.
~Treatments:
~Positioning technique
~Handling technique
~Range of motion exercises
~Taping technique"
16242922|NCT01062308|Procedure|Sham Taping|Shoulder Taping for 14 days which will be changed after every 3 days.
16242923|NCT01062295|Device|Siesta-System|
16242924|NCT01062295|Device|Standard headrest|
16242925|NCT01062282|Drug|Iloprost (Ventavis BAYQ6256)|Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis
16242926|NCT01062269|Drug|Cholestyramine|Cholestyramine 4 grams one time dose
16242927|NCT01062269|Drug|Cholestyramine|Cholestyramine 12 grams one dose, one day
16242928|NCT01062269|Drug|Tang|Tang one dose one day
16242929|NCT01062256|Drug|Placebo|One placebo tablet administered orally as a single dose
16242930|NCT01062256|Drug|Guaifenesin|One 400 mg immediate release tablet administered orally as a single dose
16242931|NCT01062256|Other|Buckwheat Honey|10 mL administered orally as a single dose
16242932|NCT01062243|Behavioral|Brain Injury Education|The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation.
16242933|NCT01062230|Drug|Bortezomib (Velcade)|"Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
~Patients will undergo three 21-day cycles."
16242934|NCT01062204|Device|Altrazeal|Sterile, odorless, crystalline white powder consisting of flakes of freeze dried HEMA and HPMA polymers. For application, the powder is distributed to the surface of the wound or burn where it forms a moist, flexible film and adheres to the surface of the wound.
16242935|NCT01062204|Device|Aquacel Ag|Textile fiber made from sodium carboxy-methylcellulose containing 1.2% silver in ionic form.
16242936|NCT01062191|Device|Aquacel AG, typical carboxymethylcellulose dressing|"4 X 4, Aquacel silver sheet"
16242937|NCT01062191|Device|Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing|Wound dressing
16242938|NCT01062178|Drug|Definity|Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.
16242939|NCT01062165|Drug|Caspofungin|Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
16242940|NCT01062152|Drug|Ezatiostat Hydrochloride|Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM & 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
16242941|NCT01062152|Drug|Lenalidomide (Revlimid®)|10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
16242942|NCT01062139|Drug|Xarlin (Levocetirizine)|Combination therapy compared to mono therapy
16242943|NCT01062139|Drug|Cosalin (Petasites hybridus CO2 extract)|Combination therapy compared to mono therapy
16242944|NCT01062113|Drug|Celecoxib|"Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with moderate pain or severe painrated as 45.0 mm or more on the VAS"
16242945|NCT01062113|Drug|Celecoxib|Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
16242946|NCT01062113|Drug|Placebo|Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
16242947|NCT01062100|Device|nuclear breast imaging using MBI Gamma camera|nuclear breast imaging using MBI Gamma camera in addition to MRI
16242948|NCT01062087|Drug|Bupivacaine, Lidocaine|Injection at surgical port site of 0.25% Bupivicaine, 2.5 mg/mL NaCl solution and/or application of Lidocaine HCl jelly 2% aqueous, up to 5 mL
16242949|NCT01062061|Biological|VARIVAX™|Attenuated live varicella vaccine
16242950|NCT01062048|Drug|Sitagliptin|Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label
16242951|NCT01062048|Drug|Sulfonylurea|Sulfonylurea administered in general use according to the local label
16242952|NCT01062048|Biological|Insulin|Insulin administered in general use according to the local label
16242953|NCT01062022|Behavioral|Standard of Care|Families randomized to this arm will receive the standard of care. They will be compared to the families in the FOCUS-CI arm of the study.
16242954|NCT01062022|Behavioral|FOCUS-CI|Families randomized to this arm of the study will be part of a family skill-building/resiliency training program designed to provide information and skills training
16242955|NCT01062009|Drug|Zinc sulfate|Zinc sulfate 200 mcg/ml in Normal Saline
16242956|NCT01061996|Drug|Basiliximab|Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
16242957|NCT01061983|Device|Medtronic Activa Deep Brain Stimulation|In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
16242958|NCT01061970|Drug|Fispemifene|once daily for 4 weeks
16242959|NCT01061931|Procedure|Arctic Front® catheter vs. HD Mesh Ablator® catheter|Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter
16242960|NCT01061918|Device|Tecnis MF|20 patients in the Tecnis MF group.
16242961|NCT01061918|Device|ReSTOR|20 patients in the ReSTOR group.
16242962|NCT01061905|Behavioral|Calorie information|Posting of Calorie information for sugar-sweetened and zero-calorie beverages
16243097|NCT01060956|Other|reporting of two different bacteria in urine culture|reporting of two different bacteria in urine culture
16242964|NCT01061905|Behavioral|Calorie & Exercise equivalent information|Posting of both calorie and exercise equivalents information for both sugar-sweetened and zero-calorie beverages, prominently on a poster.
16242965|NCT01061866|Drug|3-phthalimidoglutarimide (Thalidomide)|Thalidomide at 200 mg dosage bid was administered during a twelve month period.
16242966|NCT01061853|Drug|TOPICAL SIROLIMUS (RAPAMUNE*)|APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
16242967|NCT01061853|Drug|TOPICAL BETAMETHASONE 0.05%|APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months
16242971|NCT01061814|Drug|mipomersen|30 mg (cohort A), 70mg (cohort B) or 200mg (cohort C) subcutaneous (SC) dose of study drug daily for 3 weeks
16242972|NCT01061814|Drug|Placebo|30 mg (cohort A), 70mg (cohort B), or 200mg (cohort C) subcutaneous (SC) dose of study drug daily for 3 weeks
16242973|NCT01061801|Behavioral|Emotional expression|Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver
16242974|NCT01061788|Drug|AMG 479, Everolimus, Panitumumab|"Dose Escalation Cohort #, Subjects, Everolimus, AMG 479
~3-6 subjects, Study drug administered per dose level
~3-6 subjects, Study drug administered per dose level
~Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level
~Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab
~3-6 subjects, Study drug administered per dose level
~3-6 subjects, Study drug administered per dose level
~Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level
~NSCLS Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level"
16242975|NCT01061775|Drug|Exenatide|5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
16242976|NCT01061762|Behavioral|Stick To It|3-counseling session adherence intervention tailored for people with poor literacy skills
16242977|NCT01061762|Behavioral|Standard medication adherence counseling|3 counseling sessions for adherence improvement derived from standard behavioral approaches.
16242978|NCT01061762|Behavioral|Health Counseling|3-session of health improvement counseling to serve as an attention control.
16242979|NCT01061749|Biological|Cixutumumab|Given IV
16242980|NCT01061749|Other|Laboratory Biomarker Analysis|Correlative studies
16242981|NCT01061749|Other|Pharmacological Study|Correlative studies
16242982|NCT01061749|Drug|Selumetinib|Given PO
16242983|NCT01061736|Drug|Sarilumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16242984|NCT01061736|Drug|Placebo (for sarilumab)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16242985|NCT01061736|Drug|Methotrexate|Same weekly dose as received prior to enrollment
16242986|NCT01061736|Drug|Folic Acid|According to local standard
16242987|NCT01061723|Drug|Sarilumab|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16242988|NCT01061723|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16242989|NCT01061710|Drug|varenicline|Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks.
16242990|NCT01061697|Drug|Pregabalin|At week 0, pregabalin 75mgbd will be given for 1 month. If visual analogue scale is not reduced by 50% after 1 month, pregabalin will be increased to 150mgbd for the second month
16242991|NCT01061671|Drug|simvastatin|40 mgms of simvastatin daily
16242992|NCT01061671|Drug|Placebo|Matched placebo pill daily
16242993|NCT01061658|Biological|Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine|Higher dosage of vaccine
16242994|NCT01061658|Biological|Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine|Lower dosage of vaccine
16242995|NCT01061658|Other|Placebo|Placebo
16242996|NCT01061645|Drug|MOC31-PE|Immunotoxines
16242997|NCT01061632|Procedure|High intensity motor control exercise (deadlift)|12 treatment sessions over a 8 week period is planned for the high intensity motor control exercise.
16242998|NCT01061632|Procedure|Low intensity motor control exercise|12 sessions of low intensity motor control exercises over 8 weeks
16242999|NCT01061606|Drug|temsirolimus|Given IV
16243000|NCT01061593|Dietary Supplement|Immunoxel|1 lozenge once per day
16243001|NCT01061593|Other|Placebo|1 lozenge once per day
16243002|NCT01061580|Device|Harvest SmartPReP2 BMAC System|Injection of 10, 15, or 20 cc of BMAC
16243003|NCT01061554|Dietary Supplement|Omega-3 oils from tri-glycerides|Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
16243004|NCT01061554|Dietary Supplement|Omega-3 oils from marine phospholipids|Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids
16243005|NCT01061541|Biological|Tritanrix™-HepB low thio /|One dose as intramuscular injection at 6, 10 and 14 weeks of age.
16243006|NCT01061541|Biological|Hib 2.5|One dose as intramuscular injection at 6, 10 and 14 weeks of age.
16243007|NCT01061541|Biological|Tritanrix™-HepB|One dose as intramuscular injection at 6, 10 and 14 weeks of age.
16243008|NCT01061541|Biological|Hiberix™|One dose as intramuscular injection at 6, 10 and 14 weeks of age.
16243009|NCT01061541|Biological|Unconjugated Hib vaccine (plain PRP)|One dose as intramuscular injection at 10 months of age
16243010|NCT01061528|Drug|Transdermal Nicotine|Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
16243011|NCT01061515|Drug|Intraperitoneal Oxaliplatin|
16243012|NCT01061515|Drug|Bevacizumab|
16243013|NCT01061515|Drug|Capecitabine|
16243322|NCT01059188|Drug|docetaxel|85 mg/m2 day 1 of 21 day cycles, for 3 cycles
16243014|NCT01061502|Device|Procellera (Bioelectric Wound Dressing)|Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed
16243015|NCT01061502|Device|Opsite (Transparent Adhesive Dressing)|Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.
16243016|NCT01061489|Other|auditory discrimination training|10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home
16243017|NCT01061489|Other|physical movement training|10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)
16243018|NCT01061476|Device|Treatment sleep study (Provent™ device used)|The patient's sleep apnea severity is determined on this night while using the Provent™ device. The patient only uses the Provent™ device on this night (single night use only).
16243019|NCT01061476|Other|Baseline sleep study (No device)|The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device.
16243020|NCT01061476|Other|Physiology sleep study (Provent™ on/off)|During this sleep study night, the patient is sleeping with a modified Provent™ device that can be turned on and off to assess changes in airflow during the night (single night use only).Provent™ on/off is bracketed in 10 minute intervals during stable stage 2 sleep.
16243021|NCT01061450|Drug|Simvastatin|80 mg once a day
16243022|NCT01061450|Drug|Placebo|1 pill once a day
16243023|NCT01061437|Drug|PACx14|Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
16243024|NCT01061437|Drug|PACMx5|Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
16243025|NCT01061437|Drug|PAx5/PCMx5|Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)
16243026|NCT01061424|Behavioral|community health worker|community health worker provides home visits for education
16243027|NCT01061424|Behavioral|mailed information|information on asthma is mailed to the home on the same schedule as the other arm
16243028|NCT01061411|Drug|Dalteparin|Given SC
16243029|NCT01061411|Other|Pharmacological Study|Correlative studies
16243030|NCT01061411|Drug|Sunitinib Malate|Given PO
16243031|NCT01061398|Procedure|Cardiac CT Angiography|Patients randomized to CT Arm will undergo 64-slice cardiac CT angiography (single scan) in addition to the stress imaging test ordered by their physician
16243032|NCT01061398|Procedure|Stress Imaging Test (Stress Myocardial Perfusion Study or Stress Echocardiogram)|Stress imaging test as ordered by the subjects provider without option for cardiac CT angiography (no CT arm)
16243033|NCT01061385|Device|ReShape Intragastric Balloon|Placement of ReShape Medical Intragastric Balloon for twenty four weeks
16243034|NCT01061385|Other|Control Arm|Behavioral Modification (Diet and exercise counseling) alone
16243035|NCT01061372|Drug|Placebo|Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
16243036|NCT01061372|Drug|pregabalin|pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
16243037|NCT01061372|Drug|pregabalin|pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
16243038|NCT01061359|Drug|Epirubicin: Observational Study|Observational: Chemotherapy
16243039|NCT01061346|Other|40% Fat Diet, 20% Fructose Beverage|40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein
16243040|NCT01061346|Other|20% Glucose Beverage|40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein
16243041|NCT01061346|Other|20% Glucose Beverage|20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
16243042|NCT01061333|Drug|Nedocromil|Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
16243043|NCT01061333|Drug|Comparator: Montelukast|Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge
16243044|NCT01061333|Drug|Comparator: Mometasone|Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge
16243045|NCT01061333|Drug|Placebo|Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
16243046|NCT01061320|Drug|alpha tocopherol|The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
16243047|NCT01061320|Drug|placebo|The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
16243048|NCT01061307|Dietary Supplement|fortified extruded rice|fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
16243049|NCT01061294|Procedure|Advanced CustomVue™ iLASIK procedure|
16243050|NCT01061294|Device|WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System|
16243051|NCT01061281|Device|Tecnis MF IOL|20 patients enrolled with the Tecnis MF IOL.
16243052|NCT01061281|Device|Crystalens AO IOL|20 patients enrolled with the Crystalens AO
16243053|NCT01061268|Drug|No topical artificial tear|40 patients randomized to not using a topical artificial tear.
16243054|NCT01061268|Drug|Blink® Tears Lubricant Eye Drops|Blink® Tears Lubricant Eye Drops
16243055|NCT01061255|Other|Evaluation of the stress|"Medical Students having to solve a medical problem in ambulatory setting (studied group) vs. in hospitalisation setting (control group).
~Measures: The French version of the Anxiety Spielberger test is administered just before and after each problem solving session.
~Cortisol salivary samples are taken before and after each problem solving session. Salivary cortisol levels have been shown to be correlated to stressful situations and some personality traits but with some difference according to gender."
16243056|NCT01061242|Behavioral|Sleep promoting interventions|MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.
16243057|NCT01061229|Drug|Homeopathic drug C12|Subjects in the intervention group are instructed to take five globules of the trial drug (potency C12), five times per day for a maximum of five days (5×5×5). The study medication is obtained from DHU (Germany), produced according to the Hahnemannian method. Subjects are asked to stop taking the medication, in agreement with their investigator, if they experience any of a predefined set of proving symptoms
16243453|NCT01058083|Drug|Placebo|Placebo, Oral, 0 mg, daily, 28 days
16243058|NCT01061229|Other|Placebo|Placebo consists of pure sucrose globules (DHU, Germany) that are not potentiated nor impregnated with alcohol. The administration scheme is identical in the placebo control group to that of the intervention group.
16243059|NCT01061216|Device|Intradermal insulin delivery: BD Research Catheter Set|1 unit/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered) 2 units/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered)
16243060|NCT01061216|Device|Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set|1 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered) 2 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered)
16243061|NCT01061203|Drug|Grazax|Treatment with 75.000 SQ-T once daily
16243062|NCT01061203|Drug|Placebo|Tablet with no active grass component.
16243063|NCT01061190|Drug|Propranolol|oral application of 160 mg Propranolol for 30 days
16243064|NCT01061177|Drug|Nilotinib|Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.
16243065|NCT01061151|Drug|Zidovudine (ZDV)|300 mg twice daily
16243066|NCT01061151|Drug|Nevirapine (NVP): Antepartum Mothers|200 mg at onset of labor
16243067|NCT01061151|Drug|Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail|200 mg/300 mg x 2 tablets at onset of labor or as soon as possible thereafter; 200 mg/300 mg orally each day after delivery for 7 days or the date of the Week 1 visit (up to 14 days), whichever is later.
16243068|NCT01061151|Drug|Lamivudine-Zidovudine (3TC-ZDV)|150 mg/300 mg twice daily
16243069|NCT01061151|Drug|Lopinavir-ritonavir (LPV-RTV)|400 mg/100 mg twice daily beginning at >= 14 weeks gestation; 600 mg/150 mg twice daily beginning at >= 28 weeks gestation or at next visit (during third trimester) through delivery; 400 mg/100 mg twice daily after delivery up to 14 days postpartum.
16243070|NCT01061151|Drug|Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV])|200 mg/300 mg
16243071|NCT01061151|Drug|Nevirapine (NVP): Infant short-course|Oral suspension (dosing according to birth weight) once a day through 42 days of age or through the week 6 visit, whichever is later.
16243072|NCT01061151|Drug|Nevirapine (NVP): Infant extended|Oral suspension (dosing according to birth weight) once a day from 6 (up to 14) days of age until there was no longer any risk of MTCT or until the end of follow-up (104 weeks), whichever came first.
16243073|NCT01061151|Other|No Intervention|"Women registered before/during labor received the full Antepartum Arm A regimen.
~Women registered after labor, and who received nevirapine outside of the study, received the Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail."
16243074|NCT01061151|Other|Discontinue triple ARVs|ARVs were discontinued. When protocol specified criteria were met, mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).
16243075|NCT01061151|Other|Continue triple ARVs|Mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).
16243076|NCT01061125|Other|TTM and Holter monitor|Standard of care visits recordings reviewed during clinical visits
16243077|NCT01061112|Drug|Flurbiprofen Control - Flurbiprofen Only|A single 50 mg flurbiprofen dose taken at the start of the study period. No other drugs administered during this study period.
16243078|NCT01061112|Drug|Flurbiprofen Inhibition - Flurbiprofen & Fluconazole|A single 50 mg flurbiprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
16243079|NCT01061112|Drug|Ketoprofen Control - Ketoprofen Only|A single 75 mg ketoprofen dose taken at the start of the study period. No other drugs administered during this study period.
16243080|NCT01061112|Drug|Ketoprofen Inhibition - Ketoprofen & Fluconazole|A single 75 mg ketoprofen dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
16243081|NCT01061112|Drug|Tolbutamide Control - Tolbutamide Only|A single 500 mg tolbutamide dose taken at the start of the study period. No other drugs administered during this study period.
16243082|NCT01061112|Drug|Tolbutamide Inhibition - Tolbutamide & Fluconazole|A single 500 mg tolbutamide dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
16243083|NCT01061099|Biological|Mesenchymal Stromal Cells|Both cohorts will receive multiple infusions of ex-vivo expanded MSCs. Stratum A may use previously harvested and cryopreserved bone marrow mononuclear cells from original BMT donor or freshly harvested or cryopreserved bone marrow mononuclear cells obtained from a haploidentical healthy parent or sibling. Stratum B will only receive freshly harvested or cryopreserved bone marrow
16243084|NCT01061073|Drug|Omexel|
16243085|NCT01061073|Drug|spasfon|
16243086|NCT01061060|Drug|Prostaglandin I2|oral
16243087|NCT01061060|Drug|Placebo|oral
16243088|NCT01061047|Drug|Ertapeneme|
16243089|NCT01061034|Drug|aspirin and omeprazole|aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.
16243090|NCT01061021|Behavioral|In The Mix|Five small group + 2 individual counseling intervention designed to addresses HIV transmission risk behavior and HIV treatment adherence in men and women living with HIV/AIDS.
16243091|NCT01061021|Behavioral|Information Support Group|Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.
16243092|NCT01061008|Other|Post operative progressive handgrip exercise|As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
16243093|NCT01061008|Other|Treatment as usual|Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)
16243094|NCT01060982|Device|Ultrasonic ablation device|One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
16243095|NCT01060969|Drug|Tadalafil and acetazolamide|Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.
16243098|NCT01060956|Other|"reporting mixed growth on urine culture"|"reporting mixed growth on urine culture"
16243099|NCT01060943|Device|KOKEN|"atelocollagen filler
~1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year."
16243100|NCT01060943|Device|Atelocollagen Filler|1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year.
16243101|NCT01060930|Drug|Intravenous infusion of L-NMMA and Nor-epinephrine|Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min. Each infusion to run over 15 mins and separated by 45 min to allow return to baseline. Drugs infused in a randomised order. During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.
16243102|NCT01060917|Device|Non-invasive CGMS (continuous glucose monitoring system)|A non-invasive continuous glucose monitoring device measure was applied at the wrist and measure skin glucose as an indirect measure of blood glucose every 10 min.
16243103|NCT01060917|Procedure|Hyperglycemic and hypoglycemic glucose clamp|The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (300 mg/dL) for 1.5 h, and euglycemia (100 mg/dL) for another 1.5 h. A continuous somatostatin infusion was initiated after the 2 h run-in period to suppress endogenous insulin secretion. A glucose solution was infused to increase blood glucose towards the hyperglycemic target level. At the end of the hyperglycemic level the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level. On a second study day a hypoglycemic clamp took place, where blood glucose after the run-in period of 2 h was lowered by means of intravenous insulin administration over a period of appr. 30 min to a hypoglycemic level of 45 mg/dL, where it was kept constant for appr. 30 min, after which blood glucose was raised to euglycemia (100 mg/dL) again by means of an intravenous glucose infusion and was kept there for 1.5 hours. .
16243104|NCT01060917|Device|Non-invasive CGMS (GlucoDay)|The minimally-invasive glucose sensor GlucoDay, was used as a control measure
16243105|NCT01060904|Drug|brentuximab vedotin|0.6-1.2 mg/kg IV every 2 weeks
16243106|NCT01060904|Drug|doxorubicin|25 mg/m2 IV every 2 weeks
16243107|NCT01060904|Drug|vinblastine|6 mg/m2 IV every 2 weeks
16243108|NCT01060904|Drug|dacarbazine|375 mg/m2 IV every 2 weeks
16243109|NCT01060904|Drug|bleomycin|10 units/m2 IV every 2 weeks
16243110|NCT01060904|Drug|brentuximab vedotin|0.9-1.2 mg/kg IV every 2 weeks
16243111|NCT01060891|Drug|colimycin|
16243112|NCT01060878|Drug|PYM50028|IMP
16243113|NCT01060878|Drug|Placebo|Matching placebo comprising identical vehicle to active doses
16243114|NCT01060865|Drug|Aliskiren|150 mg during the first two weeks , 300 mg for another 10 weeks
16243115|NCT01060852|Behavioral|Media Detective|10-lesson elementary school, media literacy education, substance use prevention program. Each lesson takes approximately 45 minutes to teach and was taught every school day for 2 weeks.
16243116|NCT01060839|Behavioral|Single session counseling|For index cases assigned to the counselling arm, a same sex counselor conducted 10-15 minutes individualized sessions. Counselors were specifically trained to deliver partner referral counselling focusing on five issues related to STI prevention and transmission: (1) risk of re-infection if partners are not treated concurrently; (2) risk of developing complications; (3) risk of further spread of infection in the community; (4) the asymptomatic nature of infection; and (5) social obligations and personal coping with an STI.
16243117|NCT01060826|Other|fisiologic serum|250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure
16243118|NCT01060826|Drug|somatostatin, intravenous bolus|250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic
16243119|NCT01060826|Drug|somatostatin|Intravenous bolus 250 micrograms
16243120|NCT01060813|Dietary Supplement|Leucine supplements|leucine supplements
16243121|NCT01060787|Procedure|Fluocinolone Acetonide 0.59 mg|At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
16243122|NCT01060787|Procedure|Fluocinolone Acetonide 2.1 mg|At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
16243123|NCT01060774|Drug|Lidocaine|Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively
16243124|NCT01060774|Drug|Bupivacaine|Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
16243125|NCT01060761|Behavioral|Rehabilitation program|"Patient and their relative receive three supportive, structured conversation with a trained nurse.
~Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities"
16243126|NCT01060748|Biological|ACE527|ACE527 comprises a mixture of three live, attenuated ETEC strains; ACAM2025 (CFA/I+ and LTB+), ACAM2022 (CS5+, CS6+ and LTB+), and ACAM2027 (CS1+, CS2+, CS3+ and LTB+). The vaccine is administered orally as a two-dose regimen, at 9x1010 cfu, on Days 0 and 21, in 200 ml CeraVacx buffer. The required volume of each vaccine strain, supplied as a frozen suspension, is mixed into the buffer solution prior to dosing.
16243127|NCT01060748|Biological|Placebo|Placebo
16243128|NCT01060735|Dietary Supplement|Vitamin D|Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
16243129|NCT01060722|Drug|MOD-4023 (long lasting hGH)|Single subcutaneous dose of MOD-4023
16243130|NCT01060722|Drug|Placebo|Single subcutaneous dose of placebo material
16243131|NCT01060696|Drug|Mefenamic acid or Hyoscine or placebo|Mefenamic acid 500 mg. single oral use 30 minutes before SIS Hyoscine 10 mg. single oral use 30 minutes before SIS Placebo single oral use 30 minutes before SIS
16243132|NCT01060683|Biological|Hemoglobin determination + NaCl 0.9% bolus|
16243133|NCT01060683|Biological|hemoglobin determination + Venofundin bolus|
16243134|NCT01060670|Device|Integra® Dermal Regeneration Template|Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
16243135|NCT01060670|Other|Conventional Wound Therapy|Conventional Wound Therapy
16243136|NCT01060631|Device|BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations|Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
16243137|NCT01060631|Device|BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations|Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study
16243138|NCT01060618|Other|Maraviroc + Trofile ESTA® (diagnose test)|The Trofile ESTA® will be performed in those patients and once the results are obtained (within one month approximately), the patients will be treated with the medication Maraviroc
16243139|NCT01060605|Drug|rapamycin|Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL).
16243140|NCT01060592|Device|EndoFLIP device (FDA Device Listing Number : D091203)|The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.
16243141|NCT01060579|Drug|AR-12286 0.5% ophthalmic solution|q.d. PM
16243142|NCT01060579|Drug|AR-12286 0.25% Ophthalmic solution|q.d. PM
16243143|NCT01060579|Drug|Latanoprost ophthalmic solution|q.d. PM
16243144|NCT01060566|Drug|VX-770|In period 1, subjects will receive a single oral dose of midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10.
16243145|NCT01060566|Drug|VX-770|In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9.
16243146|NCT01060553|Other|Acupuncture treatment|This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment. Due to the very small number of subjects in the wait list control, the ones who completed 6 or 12 weeks of acupuncture after the wait list were combined with the few who completed the initial acupuncture for a pre-post single group analysis. for those who completed both the 6 and 12 week measures, the latest one was selected for analysis
16243147|NCT01060540|Genetic|genetic testing for type 2 diabetes|TCF7L2, PPARG, or KCNJ11
16243148|NCT01060540|Behavioral|Conventional risk counseling|Risk based on lifetime risk, fasting plasma glucose results, and family history.
16243149|NCT01060540|Behavioral|eye disease counseling|addresses risk for age-related macular degeneration, glaucoma, cataracts
16243150|NCT01060514|Drug|Pazopanib|dose escalation, administered orally, daily
16243151|NCT01060514|Drug|Vinorelbine|dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)
16243152|NCT01060501|Drug|Folinic Acid, interferon-alpha|5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)
16243153|NCT01060488|Other|GHRH+Arg, GHRH+Arg, ITT|GHRH+Arg repeatability test (2 tests) + comparison with one IT test
16243154|NCT01060488|Other|ITT, ITT, GHRH+Arg.|IT repeatability test (2 tests) + comparison with one GHRH+Arg test
16243155|NCT01060475|Drug|LIM-0705 and tacrolimus|Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
16243156|NCT01060475|Drug|LIM-0705 and tacrolimus|Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
16243157|NCT01060475|Drug|Placebo LIM-0705 and tacrolimus|Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
16243158|NCT01060475|Drug|Drug LIM-0705 and placebo tacrolimus|Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.
16243159|NCT01060462|Drug|Pts. w/ neutropenic fever associated w/ hematologic malignancy|Itraconazole 200 mg twice daily for 2 days for a total of 4 doses, then 200 mg once daily for 12 days. After 14 days of IV administration, itraconazole oral solution 200 mg twice daily should be continued for a total of 14 days until clinically significant resolution of neutropenia resolves
16243160|NCT01060449|Other|LV stimulus intensity|"The voltage and pulse duration used for programmed LV pacing
~Arm 1: LV lead low output Arm 2: LV lead high output"
16243161|NCT01060436|Device|CPAP or BiPAP machines|Nightly use of CPAP or BiPAP at a pressure recommended by the subject's treating physician
16243162|NCT01060423|Drug|Cetuximab|Starting dose of 400mg/m2, followed by weekly 250mg/m2
16243163|NCT01060423|Drug|Irinotecan|Irinotecan 180 mg/m² to be administered every two weeks
16243164|NCT01060423|Device|Irinotecan eluting BEADS|A minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen).
16243165|NCT01060410|Genetic|Polymorphism Analysis|Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide
16243166|NCT01060410|Drug|Cyclophosphamide|intravenous injection, 0.2g, once every two days
16243167|NCT01060410|Other|Pharmacokinetic analysis|laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma
16243168|NCT01060397|Behavioral|Extended Brief Intervention|Frames motivational interviewing approach
16243169|NCT01060397|Behavioral|Control|Usual care
16243170|NCT01060384|Drug|Lenalidomide|"Dose Cohort -1^ 10mg daily on Days 1-21 every 28 days
~Dose Cohort +1^^ 15mg daily on Days 1-21, every 28 days
~Dose Cohort +2 20 mg daily on Days 1-21, every 28 days
~Dose Cohort #3 25 mg daily on Days 1-21, every 28 days
~^Used only if Dose Cohort +1 requires further reduction
~^^Starting Dose Cohort in Phase I"
16243171|NCT01060384|Drug|ofatumumab|8 weekly infusions of ofatumumab 1000mg.
16243172|NCT01060371|Genetic|All Participants|If you decide to participate in this study, we will collect 1 tablespoon (15 milliliters) of blood during the first/screening visit in order to extract your DNA.
16243173|NCT01060358|Procedure|method (non-surgical) to measure neuromuscular neutral zones|
16243174|NCT01060345|Drug|Polyphenon E|three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
16243175|NCT01060332|Other|Body Constitution Questionnaire|Body Constitution Questionnaire was a tool for the study of objective evaluation of diagnostics of Traditional Chinese Medicine. It has been well developed with good validation and consistency.
16243176|NCT01060293|Drug|High-dose furosemide|High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
16243177|NCT01060293|Drug|Low-dose furosemide|Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
16243178|NCT01060293|Drug|Low-dose furosemide combined with low-dose dopamine|Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours
16243179|NCT01060280|Behavioral|Education on active management|Routine clinical practice plus education on active management.
16243180|NCT01060280|Other|Group GDS physiotherapy|Routine clinical practice (which will be substituted by Group GDS) plus education on active management.
16243181|NCT01060280|Other|Individual GDS physiotherapy|Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.
16243182|NCT01060267|Drug|Erythromycin|The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
16243183|NCT01060267|Drug|Placebo|patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.
16243186|NCT01060241|Other|Internet Intervention|The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
16243187|NCT01060228|Drug|paliperidone ER|1 tablet of 500 mg once daily on Day 1 and Day 15
16243188|NCT01060228|Drug|divalproex sodium ER|2 tablets of 500 mg once daily from Days 5 through 18
16243189|NCT01060215|Procedure|Normal saline|20 cc normal saline injection into the knee joint
16243190|NCT01060202|Drug|No intervention|This is an observational study. Patients receiving bortezomib injection intravenously (into a vein) 1.3 mg/m2 twice a week for 21 days will be observed.
16243191|NCT01060189|Drug|Ulinastatin|
16243192|NCT01060189|Drug|Tranexamic Acid|
16243193|NCT01060189|Drug|Saline Solution|
16243194|NCT01060176|Drug|Tranexamic Acid|
16243195|NCT01060176|Drug|Saline Solution|
16243196|NCT01060163|Drug|Tranexamic Acid|A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery
16243197|NCT01060163|Drug|Saline|Saline served as placebo
16243198|NCT01060150|Drug|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.
16243199|NCT01060137|Drug|fentanyl matrix|Fentanyl transdermal patch 12 - 25mcg/hr
16243200|NCT01060124|Drug|Fentanyl D-trans|Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
16243201|NCT01060111|Drug|Topiramate Standard|Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
16243202|NCT01060111|Drug|Topiramate Slow|Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion.
16243203|NCT01060111|Drug|Propranolol booster|Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
16243204|NCT01060098|Drug|anti-TNF therapy (etanercept or adalimumab)|Biological DMARD
16243205|NCT01060072|Drug|Loteprednol etabonate|Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
16243206|NCT01060072|Drug|Vehicle of Loteprednol Etabonate|Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
16243207|NCT01060059|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16243208|NCT01060059|Drug|basal insulin|subcutaneous injection, dosing according to physician's clinical judgment
16243209|NCT01060033|Device|MR Spectroscopy|
16243210|NCT01060033|Device|Fat-Saturation and Diffusion-Weighted Imaging|
16243211|NCT01060033|Device|Dynamic Contrast Enhancement MRI (MR-DCE)|
16243212|NCT01060033|Device|Diffusion Tensor Imaging (DTI)|
16243213|NCT01060020|Drug|Sildenafil|Single oral dose of 40mg or 80mg of Sildenafil
16243214|NCT01060007|Radiation|External beam radiation|
16243215|NCT01060007|Drug|Oxaliplatin|
16243216|NCT01060007|Drug|Leucovorin|
16243217|NCT01060007|Drug|5-FU|
16243218|NCT01060007|Drug|Capecitabine|
16243219|NCT01059994|Drug|Placebo sildenafil|Oral, daily, 1 week.
16243220|NCT01059994|Drug|Sildenafil|oral, 25mg, daily for 1 week
16243221|NCT01059955|Drug|Dexamethasone Phosphate Ophthalmic Solution (EGP-437)|Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only).
16243222|NCT01059955|Drug|Dexamethasone phosphate ophthalmic solution|Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
16244070|NCT01053611|Drug|propofol + remifentanil 6 ng/ml|
16243223|NCT01059942|Other|mock handoff exposure|Attending and house-staff physicians will analyze six video scenarios using the Hand-off CEX, rating each of the dimensions of hand-off competence for both the senders and receivers of the mock hand-off.
16243224|NCT01059942|Other|Introduction of CEX tool in Actual Hand-offs|We will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs.
16243225|NCT01059929|Drug|Dexmedetomidine|continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
16243226|NCT01059929|Drug|Propofol|continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS
16243227|NCT01059929|Drug|Fentanyl|25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale
16243228|NCT01059929|Drug|Midazolam|0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)
16243229|NCT01059929|Behavioral|Physical and Occupational Therapy|Daily therapy sessions targeting range of motion, strength, and mobility
16243230|NCT01059903|Drug|Rotigotine transdermal patch|Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
16243231|NCT01059890|Drug|cefotaxime|
16243232|NCT01059890|Drug|Metronidazole|
16243233|NCT01059890|Drug|Ciprofloxacin|
16243234|NCT01059890|Drug|Fosfocine|
16243235|NCT01059877|Device|1072nm infrared Photobiomodulation|1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
16243236|NCT01059877|Device|Photobiomodulation SIMULATED|Device mounted and procedure followed but with no stimulation.
16243237|NCT01059864|Drug|CP-690,550|12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
16243238|NCT01059864|Drug|Atorvastatin|Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
16243239|NCT01059864|Drug|CP-690,550|12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
16243240|NCT01059864|Drug|Atorvastatin Placebo|Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
16243241|NCT01059851|Drug|Suvorexant|single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with ~240 mL of water after an 8 hour fast
16243242|NCT01059838|Behavioral|sentence recognition|testing the ability for sentence recognition in quiet and in noise.
16243243|NCT01059825|Drug|Placebo to Ertugliflozin|Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
16243244|NCT01059825|Drug|Ertugliflozin 1 mg|Tablet, 1 mg, once daily for 84 days
16243245|NCT01059825|Drug|Ertugliflozin 5 mg|Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
16243246|NCT01059825|Drug|Ertugliflozin 25 mg|Tablet, 25 mg, once daily for 84 days
16243247|NCT01059825|Drug|Sitagliptin 100 mg|Tablet, 100 mg, once daily for 84 days
16243248|NCT01059825|Drug|Placebo to Sitagliptin|Tablet, matching placebo to 100 mg, once daily for 84 days
16243249|NCT01059825|Drug|Metformin|Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
16243250|NCT01059812|Drug|insulin degludec/insulin aspart|Injected subcutaneously twice daily. Dose was individually adjusted.
16243251|NCT01059812|Drug|biphasic insulin aspart 30|Injected subcutaneously twice daily. Dose was individually adjusted.
16243252|NCT01059799|Drug|insulin degludec|Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
16243253|NCT01059799|Drug|insulin glargine|Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
16243257|NCT01059773|Drug|Ustekinumab|Patients weighting ≤ 100 kg will receive ustekinumab 45 mg at Weeks 0, 4 and 16. Patients who achieve a PASI 75 response at Week 28 and 40 will continue receiving ustekinumab 45 mg at Week 28 and 40. Patients who fail to achieve PASI 75 response at Week 28 will receive ustekinumab 90 mg at Week 28 and 40. Patients who achieve a PASI 75 response at Week 28, but fail to achieve PASI 75 response at Week 40 will receive ustekinumab 90 mg at Week 40. Patients > 100 kg will receive ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40, regardless of achievement of PASI 75 response. Consideration will be given to discontinuing treatment in these patients if they show no response at Week 28.
16243258|NCT01059773|Drug|Methotrexate|Gradual reduction of methotrexate therapy over the 4 week period after Week 0. The methotrexate dose reduction regime will depend on the dose of methotrexate at screening. All patients will stop methotrexate regardless of the final dose after 4 overlapping weeks. The last dose of methotrexate will be given within the 7 day period before the second dose of ustekinumab.
16243259|NCT01059760|Behavioral|Fasting First|28±4 hours of water-only fasting followed by 28±4 hours fed
16243260|NCT01059760|Behavioral|Fed First|28± 4 hours fed followed by 28± 4 hours of fasting
16243261|NCT01059747|Other|no intervention applied|no intervention applied
16243262|NCT01059734|Genetic|DNA analysis|
16243263|NCT01059734|Genetic|RNA analysis|
16243264|NCT01059734|Genetic|mutation analysis|
16243265|NCT01059734|Genetic|polymerase chain reaction|
16243266|NCT01059734|Genetic|polymorphism analysis|
16243267|NCT01059734|Other|laboratory biomarker analysis|
16243268|NCT01059721|Procedure|Medialising insertion of patella tendon|surgical treatment of medialising tibial tuberosity
16243269|NCT01059682|Drug|Dalcetrapib|Dalcetrapib 600 mg orally once daily
16243270|NCT01059682|Drug|Placebo|Placebo orally once daily
16243271|NCT01059669|Other|diagnostic test|
16243272|NCT01059656|Drug|Pazopanib|Administration of pazopanib per os 800mg/ qd during 6 months until stable response according to primary endpoint, with 3 monthly successive examinations, and for a period of study not exceeding 18 months.
16243319|NCT01059253|Other|AdvanStep training program - Turtle Pop|Balance / mobility exercise program using the AdvanStep in a virtual reality context
16243320|NCT01059188|Drug|cetuximab|400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks
16243273|NCT01059643|Drug|LY2523355|Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.
16243274|NCT01059643|Drug|pegfilgrastim|6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.
16243275|NCT01059630|Drug|Obinutuzumab|IV infusion.
16243276|NCT01059630|Drug|Bendamustine|IV infusion.
16243277|NCT01059617|Biological|GSK Biologicals' FluLaval®|Intramuscular injection
16243278|NCT01059617|Biological|Placebo (saline)|Intramuscular injection
16243279|NCT01059617|Biological|GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A|Intramuscular injections
16243280|NCT01059617|Biological|GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A|Intramuscular injections
16243281|NCT01059604|Drug|Sumatriptan|Sumatriptan
16243282|NCT01059604|Drug|Naratriptan|Naratriptan
16243283|NCT01059604|Drug|Sumatriptan-naproxen combination|Sumatriptan-naproxen combination
16243284|NCT01059591|Drug|GSK424887|GSK424887 2mg, 10mg, 50mg, 100mg capsule
16243285|NCT01059591|Drug|Placebo|Placebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule
16243286|NCT01059591|Radiation|PET|Each subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
16243287|NCT01059578|Drug|GSK206136|GSK206136 2mg, 10mg, 50mg, 100mg capsule
16243288|NCT01059578|Drug|PLACEBO|Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule
16243289|NCT01059578|Radiation|PET|Each subject will undergo 3 PET Scans ; one at Baseline and the others following dosing with GSK206136 at approximately 2 hours post-dose and 24 hours post-dose
16243290|NCT01059565|Drug|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer.
16243291|NCT01059565|Drug|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer.
16243292|NCT01059552|Drug|vorinostat|vorinostat once daily for 12 weeks of therapy
16243293|NCT01059539|Drug|Cariprazine|Cariprazine was supplied in capsules.
16243294|NCT01059526|Drug|ecallantide|30 mg SC
16243295|NCT01059500|Device|Pilot Phase|Non-intervention phase to test webtool technical reliability, accurate low PTP, and calibration.
16243296|NCT01059500|Device|Intervention group, receive the numeric PTP estimate|Receive the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications.
16243297|NCT01059500|Device|No Intervention|Standard (no webtool output)
16243298|NCT01059487|Other|Traditional Chinese Medicine|Traditional Chinese Medicine includes acupuncture, herbal, tuina and other accessory techniques
16243299|NCT01059474|Drug|transdermal DMPS|"12 hr urine mercury and creatinine levels will be measured on all volunteers prior to any treatment. The urine will be collected in acid-washed or heavy-metal-free specialty containers. Each volunteer will then receive 120 mg of transdermal DMPS, applied to the bicep area of one arm. The area of application will not exceed 2% body surface area. After dosing, urine will be collected for the next 12 hours (using the same protocol and send-out procedure) and assayed for mercury and creatinine levels.
~Additionally, after dosing, an intravenous catheter will be placed in the arm of each subject for blood draws. Blood samples will be obtained at 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours and 6 hours after application of the DMPS."
16243300|NCT01059461|Drug|Cerebrolysin®|injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
16243301|NCT01059448|Drug|AMG 827|AMG 827 210 mg
16243302|NCT01059435|Drug|Romosozumab|Administered subcutaneously or intravenously
16243303|NCT01059435|Drug|Placebo|Administered subcutaneously or intravenously
16243304|NCT01059422|Drug|Raltegravir; Abacavir/Lamivudine|Raltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily
16243305|NCT01059409|Procedure|Meniscal Allograft|Meniscal Allograft
16243306|NCT01059396|Drug|propranolol|GPVH ≥ 10 mmHg - responders: propranolol.
16243307|NCT01059396|Drug|carvedilol|GPVH ≥ 10 mmHg nonresponders: carvedilol.
16243308|NCT01059396|Drug|placebo|placebo propranolol / carvedilol
16243309|NCT01059383|Drug|VECAM 40/300|1 capsule, orally, once daily at bedtime.
16243310|NCT01059383|Drug|Esomeprazole 20 mg|1 capsule, orally, once daily 30-60 min. before dinner
16243311|NCT01059370|Procedure|bowel emptying|Bowel is emptied using Peristeen® irrigation system one day, by digital stimulation another trial day or filling the bladder with saline water on a third trial day. BP is measured by Finometer Pro®, respiration frequency by BIOPACK and skin conductivity measured by Biopack and nor-epinephrine and epinephrine are measured in plasma three times during each examination.
16243312|NCT01059357|Device|Da Vinci Robotic Transoral Robotic Surgical System|(TORS) Da Vinci Robotic Transoral Robotic Surgical System
16243313|NCT01059344|Drug|Mesalamin|4.8g/day, 800 mg tablets
16243314|NCT01059331|Drug|Pregabalin|150 mg x 2 daily for 2 days
16243315|NCT01059331|Drug|Sugar pill|1 tablet x 2 daily, for 2 days
16243316|NCT01059318|Drug|Everolimus|Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg.
16243317|NCT01059305|Drug|Erlotinib|150 mg daily by mouth before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
16243318|NCT01059266|Drug|PURETHAL Grasses, 20.000 AUM/ml|subcutaneous injections of increasing doses according to the described regimen
16243323|NCT01059188|Radiation|Radiotherapy|44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment
16243324|NCT01059188|Procedure|Surgery|Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.
16243325|NCT01059175|Device|Additional Endocardial or Epicardial LV Lead|Addition of a second left ventricular endocardial or epicardial lead
16243326|NCT01059175|Device|CRT-P or CRT-D|Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
16243327|NCT01059162|Device|Laser Assisted Non-penetrating glaucoma surgery|A layer by Layer ablation of the deep sclera (under the superficial scleral flap) to achieve functional fluid percolation of the inner eye humor without penetration.
16243328|NCT01059149|Device|repetitive transcranial magnetic stimulation|MagPro x100 (MagVenture A/S, DANEMARK)
16243329|NCT01059136|Drug|Spironolactone|Unique 200mg IV dose of Potassium Canrenoate followed by 25 mg daily oral dose of Spironolactone for 6 months
16243330|NCT01059123|Drug|Amoxicillin|50 mg/kg/24H ; Per Os ; 3 times/day 6 days
16243331|NCT01059123|Drug|Amoxicillin|50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14.
16243332|NCT01059110|Drug|Salicylate ointment|cream, one application every night, for 90 days
16243333|NCT01059110|Drug|Imiquimod|cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
16243334|NCT01059110|Drug|5-Fluoro-Uracil|cream, one application every night, during 12 hours, for 90 days
16243335|NCT01059110|Drug|Cryotherapy|2 cycles of 5 seconds after obtention of halo of white
16243336|NCT01059097|Procedure|Pancreaticoduodenectomy|
16243337|NCT01059084|Drug|Valacyclovir|1000 mg tid
16243338|NCT01059071|Drug|DFMO|"Escalating doses of DFMO in a 3 +3 cohort design.
~DFMO at current cohort Dose Level orally each day for 21 day cycles
~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID"
16243339|NCT01059071|Drug|Etoposide|Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
16243340|NCT01059058|Procedure|MI Paste Plus|A trained staff member from the NW PRECEDENT dental/orthodontic office will give 3 tubes of MI Paste Plus (10% CPP-ACP + 900 ppm Fluoride paste) and instructions to the subject for home use. A pea-sized amount for each arch will be applied 2x/day for 8 weeks. Subjects will apply cream topically to the teeth with their finger or a cotton swab, spread around with their tongue, hold for 1-2 minutes, then expectorate.
16243341|NCT01059058|Procedure|PreviDent Fluoride Varnish|A trained staff member from the NW PRECEDENT dental/orthodontic office will provide a SINGLE application of PreviDent fluoride varnish (22,600 ppm Fluoride) to the subject. The total dosage will be 0.5 mL.
16243342|NCT01059058|Procedure|Normal Home Care|Subjects will receive non-prescription fluoride toothpaste (1100 ppm Fluoride) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate.
16243343|NCT01059045|Procedure|cryocontact therapy|cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices
16243344|NCT01059045|Other|Control|No intervention
16243345|NCT01059032|Other|Using a 3 dimentional post processing filter|Using a 3 dimentional post processing filter
16243346|NCT01059019|Dietary Supplement|Omega-3 Fatty Acid Supplements|Twenty patients labeled as group A (Control Group) will not receive the omega-3 supplement. The Control Group will be treated in the same standard professional way as our normal refractive patients, while another 20 patients labeled as group B (Treatment group) will be given omega- 3 supplements 1 capsule 3 x a day for 2 weeks pre op and 1 month post op plus the regular post op medications. From these supplements, this will be equivalent to 750 mg of omega 3 fatty acids (both EPH and DHA), 1000 mg of Flaxseed oil, and about 183 IU of vitamin E per day. Patients will be asking to follow up postoperatively after 2 days, 4 days, 1 week, 3 months and 6 months
16243347|NCT01059006|Procedure|PresbyLASIK|PresbyLASIK essentially involves the creation of a multifocal surface able to correct any visual defect for distance while simultaneously allowing freedom from near spectacle dependency in presbyopic patients.
16243348|NCT01058993|Drug|AMD3100 or plerixafor|The study will examine the hematological effects/safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4. Plerixafor will be administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating doses of AMD 3100, 20 micrograms per kilogram (mcg/kg), 40 micrograms per kilogram (mcg/kg), 80 micrograms per kilogram (mcg/kg), and 240 micrograms per kilogram (mcg/kg) will be examined in the patients at University of Washington General Clinical Research Center for up to 10 days, requiring subjects be available up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If normal blood neutrophil count is achieved and maintained for at least 24 hours prior to highest dose, we will stop at that level.
16243349|NCT01058980|Procedure|Additional ablation until elimination of dormant conduction|Additional RF energy will be delivered at sites of re-conduction on the circular mapping catheter in each PV. Abolition of the dormant conduction will then be assessed by repeated injections of adenosine using the same doses previously used to reveal dormant conduction. Additional ablation as described will be performed until re-injection of adenosine shows no re-conduction in any of the PV.
16243350|NCT01058980|Procedure|No additional ablation|Presence of dormant PV conduction, no additional ablation.
16243351|NCT01058980|Procedure|Registry group|Among those who will be found not to have the presence of dormant conduction, and within each site, three-quarters of the patients will be randomly selected to be included in the registry group.
16243352|NCT01058980|Procedure|Usual medical care|Clinical follow-up will be performed according to the regular follow-up after AF ablation procedures in each of the participating centers. No data will be collected after discharge.One-fourth of the patients will be randomly selected to be included in the usual medical care group.
16243353|NCT01058941|Drug|Lipoic acid and fish oil concentrate|Lipoic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months
16243354|NCT01058941|Drug|Placebo|Placebo LA and placebo oil capsules for 18 months
16243390|NCT01058577|Device|Non-invasive CGMS|A non-invasive continuous glucose monitoring device measured was applied at the wrist and measured skin glucose as an indirect measure of blood glucose every 10 min.
16243355|NCT01058928|Other|Observation of fluid leakage around tracheal tube cuffs|One milliliter of Evans blue diluted in 3.5 mL of saline solution is carefully instilled on the top of the tracheal tube cuff. In the operating room, one hour and five hours after intubation, fiberoptic bronchoscopy was performed to detect the possible presence of blue dye in the trachea. If a blue spot was seen on the trachea caudal to the tube's tip on any occasion, leakage was confirmed and the experiment was finished.
16243356|NCT01058915|Drug|Rosuvastatin 5mg|Rosuvastatin 5mg/day
16243357|NCT01058915|Drug|Rosuvastatin 40mg|Rosuvastatin 40mg/day
16243358|NCT01058902|Drug|Aspirin 75 mg|Aspirin 75 mg
16243359|NCT01058902|Other|no aspirin|nothing
16243360|NCT01058889|Device|Telemedical device|Monitoring of blood glucose,insulin dose, blood pressure, lifestyle factors with the telemedical device. Monitoring of system availability, percentage of data transfer, acceptance.
16243361|NCT01058876|Drug|Deuterated nicotine and cotinine|used as a marker for pharmacokinetic studies
16243362|NCT01058863|Drug|Albuterol Spiromax®|Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
16243363|NCT01058863|Drug|ProAir® HFA|ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
16243364|NCT01058863|Other|Placebo Inhaler|Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
16243365|NCT01058850|Biological|Rindopepimut|250 or 500 mcg; intradermal injection
16243366|NCT01058824|Drug|Lincomycin|Single Dose Hard Gelatin Capsule - oral - 500 mg
16243367|NCT01058824|Drug|Lincomycin|Single Dose Hard Gelatin Capsule - oral - 500 mg
16243368|NCT01058785|Biological|Lucanix|Monthly intradermal injections of four irradiated allogeneic TGF-beta2 antisense gene modified NSCLC cell lines. Patients are randomized to receive either 12,500,000, 25,000,000 or 50,000,000 cells per injection for up to 16 injections.
16243369|NCT01058772|Other|INDUCTION of LABOUR|Induction of labour will be performed by using dinoprostone 2 mg vaginally or dinoprostone 0.5 mg intracervically at 6-8h interval (up to 5 doses) or dinoprostone 10 mg vaginal device. Patients, in which cervical ripening does not occur (Bishop score < 7) after 5 attempts with PGE2, will be offered either oxytocin or Foley catheter induction or C-section, according to local protocols.
16243370|NCT01058759|Drug|Enoxaparin|
16243371|NCT01058759|Other|No Enoxaparin|
16243372|NCT01058746|Other|restrictive perioperative fluid management|Normosol or equivalent solution 0.5 ml/kg/fasted hour IV (8am to time of induction) during induction of Anesthesia. Maintenance IV Normosol or equivalent solution at 6 ml/kg/operative hour. Blood loss to be replaced volume: volume with colloid until transfusion criteria met. Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) at the discretion of the Anesthesiologist to maintain patient hemodynamic stability.
16243373|NCT01058746|Other|Liberal perioperative fluid management|Normosol or equivalent solution 0.5 ml/kg/fasted hr IV (8am to time of induction) of Anesthesia. Maintenance IV Normosol or equiv solution at 6 ml/kg/oper hr. At randomiz to the Liberal arm in the OR, an addit bolus of Normosol or equiv solution 1.5 ml/kg/fasted hr IV (8am to time of induction) will be given to bring the total to Normosol or equiv solution 2ml/kg/fasted hr IV (8am to time of induction). Pt will get an addit bolus of Normosol or equivalent solution 6ml/kg/oper hr. Maintenance IV Normosol or equivalent solution will then commence at 12ml/kg/operative hr with maximum of 1000 ml/operative hr. Blood loss replaced volume: with colloid, until transfusion criteria met (Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) used at the discretion of the Anes to maintain pt hemodynamic stability. Addit fluid boluses of 250ml Normosol or equivalent solution for urine output less than 1ml/kg for 2 hrs.
16243374|NCT01058733|Other|Internet|new clinical decision-supporting system for glucose monitoring, SARS, which could identify glucose data recorded by patients and make some optimal decisions.The SARS engine assigned subjects to one of three levels according to the glucose control status and glucose control method.
16243375|NCT01058720|Dietary Supplement|Vitamin D3|2000 IU orally once daily for 12 weeks
16243376|NCT01058707|Drug|MLN0128|MLN0128 capsules
16243377|NCT01058694|Behavioral|Short Message Services to Support ARV therapy adherence|Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
16243378|NCT01058681|Dietary Supplement|effect of metabolic variations on LH pulsatility|"Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.
~Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.
~PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia."
16243379|NCT01058668|Drug|Cariprazine|Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16243380|NCT01058668|Drug|Placebo|Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
16243381|NCT01058655|Drug|Everolimus|
16243382|NCT01058655|Drug|Tivozanib|
16243383|NCT01058642|Drug|ADL5747|
16243384|NCT01058642|Drug|Placebo|
16243385|NCT01058642|Drug|Pregabalin|
16243386|NCT01058629|Device|SynergEyes A2 Hybrid Contact Lens|SynergEyes A2 is a hybrid contact lens cleared by the US Food and Drug Administration (FDA) for daily wear correction of up to +20.00 and -20.00 in eyes with astigmatism up to 6.00D and for presbyopia.
16243387|NCT01058616|Drug|LTX-315 (Oncopore™)|5 mg/ml-70 mg/ml. Dosing will be done as transdermal injection of a calculated volume at day 1 and 8. Additionally weekly injections up to a maximum of 4 injections.
16243388|NCT01058603|Other|- Conventional culture medium for IVF|Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
16243389|NCT01058603|Other|- Endocell®|Embryos are cultured on ENDOCELL® from Day 2 to Day 5 (Blastocyst stage) One embryo is transferred at Day 5. Supernumerary good quality embryos are frozen.
16243447|NCT01058096|Drug|Cariprazine|Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
16243391|NCT01058577|Procedure|Hyperglycemic glucose clamp|The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (16.7 mmol/L) for at least 2.5h and euglycemia (5 mmol/L) for another 2.5h. A continuous somatostatin infusion was initiated after 1h to suppress endogenous insulin secretion. A glucose solution was infused to increase the blood glucose towards the hyperglycemic target level. At approximately t=3.5h the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level.
16243392|NCT01058551|Device|Implantable Loop Recorder Insertion|Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months
16243393|NCT01058538|Drug|L19IL2|Route: i.v. infusion (60 min) Patients will receive a minimum of 2 cycles of treatment. Each cycle is comprised of treatment on Days 1, 3 and 5 followed by a 16 days rest (1 cycle= 21 days). Patients may receive up to 4 further cycles of treatment (max. of 6 cycles in total). Patients will be initially recruited into the study in cohorts of 3 and the starting dose of L19IL2 will be 5 Mio IU IL2 equivalent. Five steps of dose escalation are planned: 5, 10, 20, 30 and 40 Mio IU IL2 equivalent). After the MTD has been established, the RD will be determined. A further 12 patients (with RCC) will receive the RD dose for a minimum of 2 cycles. For patients in the RD part of the study, patients can switch to maintenance therapy. Maintenance therapy consists of 15 Mio IU IL2 every 2 weeks. The maximum duration of the study for a patient is 12 months.
16243394|NCT01058525|Procedure|median nerve block|median nerve block performed using ultrasound guidance
16243395|NCT01058525|Procedure|median nerve block after hydro-dissection|median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance
16243396|NCT01058512|Drug|NOV-205|"There will be 4 treatment Groups with 10 patients in each group:
~Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days
~Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days
~Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days
~Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days"
16243397|NCT01058499|Behavioral|Mindfulness Based Stress Reduction Program (MBSR)|Traditional eight-week MBSR Program.
16243398|NCT01058486|Behavioral|Self-Management and Motivational Interviewing|"Post hospital discharge, patients will be referred (<2 weeks) to pulmonary rehabilitation (PR) (1-2 sessions per week for 6-8 weeks). PR visits (approximately 1 hour) will include education, strengthening and endurance exercise as the patient tolerates.
~A counselor (RN or RRT) and patient will meet once weekly after PR session. The counselor will assess the patient's self efficacy and knowledge of self-management principles of COPD. Based on the assessment and greatest needs identified by patient, the counselor will work with the participant to collaboratively develop a specific SM plan.Motivational interviewing techniques will be used.
~Following completion of PR, the counselor will contact the patient monthly to provide clinical support on SM of COPD. To ensure consistency of intervention, we will use standardized treatment procedures and phone scripts."
16243399|NCT01058460|Procedure|HPV-cytology co-testing|Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
16243400|NCT01058447|Drug|AZD1981|Oral tablet, 250 mg, single dose
16243401|NCT01058434|Drug|TKI258|
16243402|NCT01058421|Procedure|intensive physical therapy|four week course of daily intensive physical therapy
16243403|NCT01058421|Procedure|control group|four weeks of routine physical therapy
16243404|NCT01058408|Radiation|Intensity modulated radiotherapy|Administered daily 5 days per week
16243405|NCT01058408|Drug|RAD001|Taken orally once a day
16243406|NCT01058408|Drug|cisplatin|Administered intravenously once a week
16243407|NCT01058395|Drug|Minocycline|Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days.
16243408|NCT01058382|Drug|Progesterone Vaginal Suppositories|Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer
16243409|NCT01058382|Drug|Intramuscular Progesterone-in-Oil|Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer
16243410|NCT01058369|Drug|Deferasirox (Novartis Pharma)|Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
16243411|NCT01058343|Biological|IFN-K|3 to 4 IM injections over 3 months
16243412|NCT01058330|Other|Plyometric training program|The intervention is a year long individualized plyometric exercise training program. Examples of plyometric activities include jumping, hopping, running, and throwing. The number of plyometric exercises will increase gradually to prevent over training to a total of five lower extremity exercises and five upper extremity exercises
16243413|NCT01058317|Drug|Propranolol|Propranolol 2mg/kg divided twice daily
16243414|NCT01058304|Other|Group Physical Therapy for Knee OA|The group PT arm will include 6 1 to 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
16243415|NCT01058304|Other|Individual Physical Therapy for Knee OA|The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
16243416|NCT01058291|Drug|KW-6500|Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
16243417|NCT01058291|Drug|KW-6500 Placebo|Twelve weeks subcutaneous injection for the OFF state
16243448|NCT01058096|Drug|Placebo|Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
16243449|NCT01058083|Drug|BMS-770767|Active, Oral, 15 mg, Daily, 28 days
16243450|NCT01058083|Drug|BMS-770767|Active, Oral, 50 mg, Daily, 28 days
16243451|NCT01058083|Drug|BMS-770767|Active, Oral, 150 mg, Daily, 28 days
16243418|NCT01058278|Procedure|Selective Laser trabeculoplasty|The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.
16243419|NCT01058265|Other|Integrative|Integrative Medicine medical evaluation.
16243420|NCT01058265|Other|Standard|Standard general medical evaluation.
16243421|NCT01058252|Combination Product|INVOCell, Letrozole 2.5 mg, recFSH 75 IU|"OVARIAN STIMULATION:
~In previous cycles, cycle length and ovulatory status must be assessed and documented.
~STEP 1: ANOVULATION by ORAL CONTRACEPTION
~Place patients on monophasic low dose of oral contraceptive pills (OCP) such as Marvelon (Organon, 0.03 mg) continuously for 21 days, 22 days but no more.
~Before stopping the oral contraceptive pills, perform an ultrasound to check for the absence of cysts (no cyst > 10 mm).
~Give estradiol (2mg, 3 times a day) for 3 days from D21 or D22 and wait for bleeding.
~STEP 2: STIMULATION and MONITORING Day one of the cycle equals the first day of bleeding (not spotting).
~On Day 3 (D3), start letrozol 2.5mg (AROMEK) for 5 days (D7). LetrozolE can be pushed for 2 more days.
~Start hMG or FSH (75 IU a day) on Day 3 like LetrozolE and continue for 5 to 7 days without increasing the dose. The dose of hMG OR FSH can be increased to 150 IU a day if low responder."
16243422|NCT01058252|Procedure|STEP-3: LH Suppression & Monitoring|"Baseline Day-2 Ultrasound to estimate antral follicles; Follow-up TVS scans on Day- 5,6,7,8 and 9 of the stimulated cycle. Ideally the lead follicle should be 18 mm on or around day 10 of the cycle.
~• When the leading follicle reaches 14 to15 mm (D8 or D9), give Indomethacine (50 mg, 3 times a day) until the evening preceding the egg retrieval. The Indomethacine will prevent a premature ovulation.
~The endometrium should be minimum 8 mm on the day of HCG (IVF-C 5000 IU x 2)
~No need of LH testing, or E2 testsing during the stimulated cycle."
16243423|NCT01058252|Procedure|STEP-4: HCG Timing|"IVF-C (HCG 10000 IU) shall be injected to trigger the ovulation, when any of the following occur:
~E2 level is over 150 pg/ml/per mature follicle (> 15 mm)
~Domminent follicle is greater than 18 mm in mean diameter
~LH Remains as Baseline, OR
~The day when Urinary LH Surge is positive"
16243424|NCT01058252|Procedure|STEP-5: OPU, ET, Cancellation|"Ultrasound guided Ovum Pick-Up is performed 34-36 hours after IVF-C (HCG 10000 IU) injection.
~Embryo Transfer is performed after 48-72 hours of incubation at 4-8 cell stage.
~Maximum of 2 embryos are transferred, using ultrasound guided transfer.
~Cancellation Criteria:
~Poor patient compliance
~Premature Ovulation
~Premature LH Surge
~Endometrium < 7 mm
~Poor Follicular Development
~E2 Level > 2,500 pg/ml"
16243425|NCT01058252|Procedure|INVOCell (Intravaginal Culturing)|Sperm preparation through Swim-Up or Gradient is performed 1 hour prior to the oocyte retrieval; Fill the device without air bubble. Only 100000 motile spermatozoa are added into the device; After follicle aspiration, oocyte(s) are identified in the follicular fluid and immediately placed into the device; The device is closed, placed into a protective outer rigid shell and then positioned into the vaginal cavity for 2 to 3 days; No activity restriction is required for the patient, except baths. After 2 or 3 days of incubation, the retention system and the device are removed from the vagina in sterile environment. The device is opened and the contents are observed in a sterile environment under microscope to find the embryos. The two best quality embryos are loaded into embryo transfer catheter and transferred immediately unto the uterine cavity using aseptic techniques.
16243426|NCT01058239|Drug|bortezomib|Given intravenously on days 1, 4, 8 and 11 of every cycle
16243427|NCT01058239|Drug|rituximab|given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles
16243428|NCT01058226|Biological|Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)|Malaria sporozoite challenge with the wild-type NF54 strain of Plasmodium falciparum delivered by the bite of five infected Anopheles stephensi mosquitoes.
16243429|NCT01058213|Behavioral|Resistance training|Supervised training will be performed on a cable exercise system (Body Solid, Forest Park, IL) using six exercises that involve concentric and eccentric muscle actions: leg press, knee flexion, knee extension, calf raise, hip adduction, hip abduction. Subjects will perform the lower extremity exercises under the direct supervision of an exercise specialist three times per week. Subjects will perform 2 sets of 8-10 repetitions at 70% of their maximum strength for 2 weeks, then will perform 2 sets of 8-10 repetitions at 80% of their maximal strength for 2 weeks, and for the next 4 weeks they will perform 3 sets of 8-10 repetitions at 80% of their maximal strength. Sets will be separated by at least a 2-3 minute rest period for multiple-joint exercises and at least 1-2 minutes for single-joint exercises. A moderate velocity of muscle contraction (~1-2 seconds for concentric and eccentric contraction) will be used.
16243430|NCT01058213|Behavioral|Aerobic training|Cycle ergometry training will be performed in the lab on a stationary cycle ergometer, calibrated with a 4 kg weight (Monark 828E, Varberg, Sweden). Initial work rate will be 50% of peak work rate (PWR) as tolerated and will be evaluated weekly with progressive increases targeted to achieve the highest work rate tolerated for 3-5 minutes{: wks 1-2 50% PWR, wks 3-4 60% PWR, wks 5-6 70% PWR, wks 7-8 80% PWR}. An interval training protocol will be used with subjects performing four work sets of five minutes duration separated by rest intervals of unloaded cycling lasting 2-4 minutes.
16243431|NCT01058200|Device|iCup|new vacuum extractor: sterile disposable plastic cup
16243432|NCT01058200|Device|reference cup|reference cup of the obstetrical ward: metallic cup
16243433|NCT01058174|Drug|micafungin|intravenous infusion
16243434|NCT01058174|Drug|fluconazole|intravenous infusion
16243435|NCT01058174|Drug|liposomal amphotericin B|intravenous infusion
16243436|NCT01058174|Drug|caspofungin|intravenous infusion
16243437|NCT01058161|Other|high-field MRI (3 Teslas)|high-field MRI (3 Teslas)
16243438|NCT01058161|Other|high-field MRI (3 Teslas)|high-field MRI (3 Teslas)
16243439|NCT01058161|Other|high-field MRI (3 Teslas)|high-field MRI (3 Teslas)
16243440|NCT01058161|Other|high-field MRI (3 Teslas)|high-field MRI (3 Teslas)
16243441|NCT01058135|Other|Hi-maize starch (Low dose)|resistant starch
16243442|NCT01058135|Other|Hi-maize starch (High-dose)|resistant starch
16243443|NCT01058135|Other|Control (starch)|rapidly digestible starch
16243444|NCT01058122|Procedure|Collection of adverse drug events|
16243445|NCT01058109|Other|calcium-rich diet|dietary calcium intake of 1500 mg/d
16243446|NCT01058109|Other|Calcium rich diet|dietary intake of 1500 mg/d from food
16243454|NCT01058070|Device|Torax Medical, Inc. LINX Reflux Management System|Implantable device, Magnetic Esophageal Sphincter
16243455|NCT01058057|Drug|atorvastatin|atorvastatin 80mg p.o. daily seven days before PCI
16243456|NCT01058044|Other|"Evaluation of adherence to 3 oral anticancer treatment using a  Medication Event Monitoring System "|"Evaluation of adherence using a  Medication Event Monitoring System  (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy"
16243457|NCT01058031|Behavioral|MBSR|Mindfulness Based Stress Reduction
16243458|NCT01058018|Drug|RVX000222|RVX000222 twice a day for 12 weeks
16243459|NCT01058018|Drug|Placebo|Placebo twice a day for 12 weeks
16243460|NCT01058005|Drug|BG00002 (natalizumab)|300 mg intravenous injection every 4 weeks
16243461|NCT01058005|Drug|interferon beta-1a|44 mcg subcutaneous injection 3 times per week
16243462|NCT01058005|Drug|glatiramer acetate|20 mg subcutaneous injection once daily
16243463|NCT01057979|Behavioral|MET + CM for Exercise|Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Contingency management offers tangible rewards for completing verified exercise.
16243464|NCT01057979|Behavioral|MET + Exercise Contracting|Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Exercise contracting consists of weekly appointment to set specific goals for exercise in the upcoming week.
16243465|NCT01057966|Dietary Supplement|ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)|Single full strength dose capsule taken one time
16243466|NCT01057966|Dietary Supplement|ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)|Single half strength dose capsule taken one time
16243467|NCT01057966|Dietary Supplement|ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)|Single, full strength dose tablet taken one time
16243468|NCT01057953|Genetic|Blood drawn|Blood drawn for patient
16243469|NCT01057940|Procedure|DBE PEJ placement|One time procedure with follow-up telephone call.
16243470|NCT01057927|Drug|OC000459|OC000459 capsules 2x100mg BID for 28 days
16243471|NCT01057927|Drug|Placebo|Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
16243472|NCT01057914|Dietary Supplement|Nutritional supplementation with a liquid formula|The patient consumes 400 kcal from a liquid supplementation formula
16243473|NCT01057914|Other|Dietary advice|The patient receives dietary advice for one hour during the hospital stay.
16243474|NCT01057914|Other|Combination of supplement and dietary advice|The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.
16243475|NCT01057901|Drug|Flibanserin|Flibanserin 100mg administered at bedtime for 24 weeks
16243476|NCT01057901|Drug|Placebo|This is the matched placebo which will be administered two tablets daily at bedtime.
16243477|NCT01057888|Other|Autodialer|Autodialer telephone calls
16243478|NCT01057888|Other|Letters|Mailed reminder letters
16243479|NCT01057875|Other|caffeine|Starbuck's Grande Pike Roast coffee
16243480|NCT01057875|Other|No caffeine|Starbuck's Grande Pike Roast Decaffeinated Coffee
16243481|NCT01057862|Drug|Naltrexone|Targeted dosage of 50mg PO daily
16243482|NCT01057862|Other|Placebo|Sugar pills daily PO
16243483|NCT01057849|Drug|risperidone|3-6 mg per day
16243484|NCT01057849|Drug|olanzapine|5-20 mg per day
16243485|NCT01057849|Drug|Aripiprazole|10-30 mg per day
16243486|NCT01057836|Behavioral|Neck endurance training|
16243487|NCT01057836|Behavioral|Stretching|
16243488|NCT01057810|Drug|Ipilimumab|5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
16243489|NCT01057810|Drug|Placebo|Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
16243490|NCT01057797|Behavioral|Exercise-specific self-efficacy|Subjects in the experimental group will participate in a self-efficacy enhancing intervention designed to maximize (a) exercise-specific SE-UB strength training (b) self-efficacy for overcoming barriers to exercise and (c) SE-UB physical activities. The intervention incorporates strategies to maximize the primary sources of efficacy information: (a) mastery accomplishments, (b) social modeling, (c) social persuasion, (d) interpretation of physiological and affective symptoms.
16243491|NCT01057797|Behavioral|Gentle chair exercise|Gentle armchair fitness exercises will be used as a sham treatment to control for the attention that subjects receive in the two strength training groups. The armchair fitness exercises will be conducted in small groups (n=8-10 per group). Armchair exercises will include stretching of all major joints with an emphasis on the arms and shoulders, massage of muscles that can be reached from the armchair (scalp, neck, shoulders, lower back, abdomen and thighs) and imagery to promote relaxation. Each session will include: 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery for relaxation.
16243492|NCT01057797|Behavioral|upper body strength training|16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl. Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets. Each week subjects will train twice in the lab and once at home. Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.
16243493|NCT01057784|Procedure|Bariatric surgery.|Bariatric Surgery
16243494|NCT01057771|Behavioral|Meditation|Eight weeks of training in mindfulless meditation. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
16243495|NCT01057771|Behavioral|Exercise|Eight weeks of training in moderately strenuous exercise. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
16243496|NCT01057758|Drug|SIMVASTATIN|Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.
16243497|NCT01057758|Drug|PLACEBO|Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU
16243498|NCT01057719|Other|Physiotherapy|Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks
16243499|NCT01057706|Other|chiropractic|spinal manipulation and mobilization
16243500|NCT01057706|Behavioral|exercise|strengthening, stretching, balance
16243501|NCT01057693|Drug|pregabalin (Lyrica)|Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
16243502|NCT01057693|Drug|Placebo|Placebo is supplied as capsules and given 3 times daily.
16243503|NCT01057680|Dietary Supplement|creatine monohydrate|Powder, 0.1 g per day, 12 months
16243504|NCT01057680|Dietary Supplement|sugar placebo|powder, 0.1 g/day, 12 months
16243505|NCT01057667|Drug|RO5024048|1000mg bid po, 24 weeks
16243506|NCT01057667|Drug|Ribavirin [Copegus]|1000mg or 1200mg po daily
16243507|NCT01057667|Drug|peginterferon alfa-2a [Pegasys]|180mcg sc weekly
16243508|NCT01057654|Drug|Pravastatin|Pravastatin 40 mg
16243509|NCT01057654|Drug|Lifibrol|Lifibrol (K12.148; 4-(4'-tert. butylphenyl)-1-(4'-carboxyphenoxy)-2-butanol) given as a 600 mg film-coated tablet
16243510|NCT01057641|Procedure|Spacer|Implantation of a percutaneously implanted interspinous device (spacer)
16243511|NCT01057641|Other|physiotherapy|physiotherapy
16243512|NCT01057628|Drug|ipragliflozin|oral
16243513|NCT01057628|Drug|placebo|oral
16243514|NCT01057615|Dietary Supplement|Fish Oil|10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks
16243515|NCT01057615|Dietary Supplement|Ascorbic Acid|2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks
16243516|NCT01057615|Dietary Supplement|Fish Oil Placebo|10 placebo fish oil (soy bean oil) capsules per day for 3 weeks
16243517|NCT01057615|Dietary Supplement|Ascorbic Acid Placebo|2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
16243518|NCT01057589|Drug|Pemetrexed|"Triplet Combination Therapy: 500 mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles
~Maintenance Therapy: 500mg/m^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity"
16243519|NCT01057589|Drug|Cetuximab|"Triplet Combination Therapy: 400 mg/m^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.
~Maintenance Therapy: 250 mg/m^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity"
16243520|NCT01057589|Drug|Cisplatin|Triplet Combination Therapy: 75mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.
16243521|NCT01057589|Dietary Supplement|Folic Acid|Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.
16243522|NCT01057589|Dietary Supplement|Vitamin B12|Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.
16243523|NCT01057576|Dietary Supplement|An alcoholic extract of Artemisia dracunculus L.|capsule, daily dosing
16243524|NCT01057576|Other|Placebo|capsule, daily dosage
16243525|NCT01057563|Device|drug (paclitaxel)-eluting balloon (DEB)|BMS implantation after lesion predilation with DEB
16243526|NCT01057563|Device|bare-metal stent (BMS)|BMS implantation
16243527|NCT01057563|Device|Drug (paclitaxel)-eluting balloon (DEB)|BMS implantation followed by post-dilation with DEB
16243528|NCT01057550|Procedure|Autologous fascial sling|Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
16243529|NCT01057550|Procedure|TVT|Standard TVT as described by Ulmsten 1996
16243530|NCT01057550|Procedure|Pelvicol|retropubic mid urethral sling made from Pelvicol
16243531|NCT01057537|Drug|polypill|"The polypill will be taken once/day in the form of a hard capsule, to be taken orally. There are two versions of the polypill (Red Heart Pill):
~Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg."
16243532|NCT01057537|Drug|Usual cardiovascular medications|Participants in the 'Usual Care' arm will continue to take the separate, individual medications prescribed by their usual doctor, e.g. aspirin, blood pressure lowering drugs, statins.
16243533|NCT01057524|Device|High Frequency Chest Wall Oscillation (HFCWO)|Airway clearance using the high frequency chest wall oscillator device
16243534|NCT01057524|Other|Usual airway clearance|Airway clearance treatments using the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure, manual techniques or oscillating positive expiratory pressure
16243535|NCT01057511|Drug|Crinone 8%|Crinone 8%, 90mg / p.v. / Qd, 7 days totally.
16243536|NCT01057511|Drug|Progesterone|Progesterone 20mg/ i.m./ Qd, 7 days totally.
16243537|NCT01057498|Drug|RNS60|RNS60, 4ml nebulized twice daily for 15 minutes.
16243538|NCT01057498|Drug|RNS60 - single dose|RNS60, single 4 ml dose nebulized for 15 minutes
16243539|NCT01057485|Procedure|AF ablation and AV node ablation|AF ablation and AV node ablation
16243540|NCT01057485|Procedure|AV node ablation|AV node ablation
16243541|NCT01057459|Other|laboratory biomarker analysis|Correlative studies
16243542|NCT01057433|Drug|Pitavastatin (NK-104)|pitavastatin (NK-104) 4 mg once daily (QD)
16243543|NCT01057433|Drug|Lopinavir/ritonavir|lopinavir/ritonavir 800 mg/200 mg
16243544|NCT01057420|Drug|oxygen inhalation|Inhalation of 80% oxygen via face mask
16243545|NCT01057407|Drug|ASP1585|oral
16243546|NCT01057407|Drug|Sevelamer hydrochloride|oral
16243547|NCT01057394|Device|Endoscopically guided PVI Ablation|Endoscopically Guided Ablation using the EAS-AC
16243548|NCT01057394|Device|RF PVI Ablation|Radiofrequency ablation
16243549|NCT01057381|Drug|Dexmedetomidine 0.75 mcg/kg|Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
16243550|NCT01057381|Drug|Morphine 50 mcg/kg|Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
16243551|NCT01057381|Drug|Morphine 100 mcg/kg|Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
16243552|NCT01057381|Drug|Dexmedetomidine 1 mcg/kg|Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
16243553|NCT01057368|Behavioral|Day of intensive meditation practice|Long-term meditators practice for ~6 hours of meditation at each time point
16243554|NCT01057368|Behavioral|Mindfulness Based Stress Reduction (MBSR)|8-week class designed to enhance well-being through training in mindfulness meditation
16243555|NCT01057368|Behavioral|Health Enhancement Program (HEP)|8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition
16243556|NCT01057355|Procedure|EUS and/or ERCP with ethanol injections of pancreatic cyst|Lavage of cyst with 80% ethanol
16243557|NCT01057342|Drug|carboplatin|AUC 6 i.v. given after paclitaxel as the second treatment on day 1 of each 3-week cycle.
16243558|NCT01057342|Drug|paclitaxel|175 mg/m2 i.v. first treatment on day 1 of each 3-week cycle.
16243559|NCT01057342|Drug|vadimezan|1800 mg/m2 i.v. following the administration of paclitaxel and carboplatin on day 1 of each 3-week cycle
16243560|NCT01057329|Drug|Atomoxetine|mg according to body weight
16243561|NCT01057329|Drug|Duloxetine|30 mg / die
16243562|NCT01057329|Drug|Olanzapine|5mg 1 wwek and 10 mg from second week
16243563|NCT01057329|Drug|Aripiprazole|5 mg from week 1, 10 mg from week 2
16243564|NCT01057316|Device|Formula PTX Stent - Dose 1|Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
16243565|NCT01057316|Device|Formula PTX Stent - Dose 2|Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
16243566|NCT01057316|Device|Formula PTX Stent - Dose 3|Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
16243567|NCT01057303|Genetic|RNA analysis|
16243568|NCT01057303|Genetic|gene expression analysis|
16243569|NCT01057303|Genetic|reverse transcriptase-polymerase chain reaction|
16243570|NCT01057303|Other|laboratory biomarker analysis|
16243571|NCT01057290|Genetic|gene expression analysis|
16243572|NCT01057290|Genetic|protein expression analysis|
16243573|NCT01057290|Other|fluorescence activated cell sorting|
16243574|NCT01057290|Other|immunologic technique|
16243575|NCT01057290|Other|laboratory biomarker analysis|
16243576|NCT01057277|Drug|RAD001(Afinitor)|Rad001 in combination withCisplatin and Concurrent RT
16243577|NCT01057264|Drug|HAI Abraxane|Starting dose: 120 mg/m^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle
16243578|NCT01057264|Drug|Gemcitabine|Starting dose: 600 mg/m^2 by IV on Days 1 and 8 of 21 day cycle
16243579|NCT01057264|Drug|Bevacizumab|10 mg/kg IV on Day 1 of 21 day cycle
16243580|NCT01057264|Drug|Filgrastim|5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.
16243581|NCT01057251|Drug|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
16243582|NCT01057251|Drug|Placebo|5 mg or 20 mg once daily, oral administration
16243583|NCT01057238|Other|Intensive Communication System|Regular family meetings once a week, using a standard protocol
16243584|NCT01057225|Drug|carfilzomib|Given IV
16243585|NCT01057225|Drug|cyclophosphamide|Given orally
16243586|NCT01057225|Drug|thalidomide|Given orally
16243587|NCT01057225|Drug|dexamethasone|Given orally
16243588|NCT01057212|Drug|ixabepilone|Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
16243589|NCT01057212|Drug|bevacizumab|Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks.
16243590|NCT01057199|Genetic|RNA analysis|
16243591|NCT01057199|Genetic|gene expression analysis|
16243592|NCT01057199|Genetic|mutation analysis|
16243593|NCT01057199|Genetic|protein expression analysis|
16243594|NCT01057199|Other|fluorescence activated cell sorting|
16243595|NCT01057199|Other|laboratory biomarker analysis|
16243596|NCT01057186|Dietary Supplement|Alfacalcidol; phosphate.|Individual dosage form and dosage depending on phenotype and underlying cause.
16243597|NCT01057186|Drug|Sevelamer|Pills. Individual dosage depending on clinical symptoms/phenotype.
16243598|NCT01057173|Procedure|Transcatheter Aortic Valve Implantation|Retrograde trans-femoral or trans-subclavian aortic valve implantation with the Medtronic CoreValve System(TM) bio-prosthesis (third generation system, 18 Fr, CE mark approved)
16243599|NCT01057173|Procedure|Surgical Aortic Valve Replacement|Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest
16243600|NCT01057160|Drug|Rizatriptan|use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic
16243601|NCT01057147|Drug|rebamipide 2% ophthalmic suspension|Instill one drop in each eye four times daily for 12 weeks.
16243602|NCT01057147|Drug|placebo eye drops|Instill one drop in each eye four times daily for 12 weeks.
16243603|NCT01057121|Drug|Lenalidomide|Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles. Sequential cohorts were entered at 10 mg/day, 15 mg/day, 20 mg/day and 25 mg/day using a 3+3 design to determine the MTD
16243604|NCT01057108|Other|FOSTRAP Chewing Gum|20 mg BID
16243605|NCT01057108|Other|FOSTRAP Chewing Gum|40 mg BID
16243606|NCT01057108|Other|FOSTRAP Chewing Gum|20 mg TID
16243607|NCT01057108|Other|FOSTRAP Chewing Gum|20 mg TID
16243608|NCT01057108|Other|Placebo chewing gum|
16243609|NCT01057095|Genetic|RNA analysis|
16243610|NCT01057095|Genetic|gene expression analysis|
16243611|NCT01057095|Genetic|reverse transcriptase-polymerase chain reaction|
16243612|NCT01057095|Other|laboratory biomarker analysis|
16243613|NCT01057082|Dietary Supplement|Juven|Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.
16243974|NCT01054313|Drug|Docetaxel (Taxotere)|Starting dose 30 mg/m^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.
16243614|NCT01057082|Dietary Supplement|Juven|Participants in the placebo arm will be asked to consume two packets of an orange-flavored drink mix each day for a period of six months.
16243618|NCT01057056|Other|mind-body intervention|multi-disciplinary mind-body intervention including: breathing techniques, guided imagery, meditation, touch therapy
16243619|NCT01057043|Device|Pulsatile cupping|8 sessions cupping in 4 weeks, administered by a cupping machine. Cupping is administered in each session for 15 minutes with silicon cupping glasses to the knee (osteoarthritis) and the lower back.
16243620|NCT01057030|Drug|BMS-708163|Capsules, Oral, 125 mg, once daily, 14 days
16243621|NCT01057030|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 14 days
16243622|NCT01057017|Biological|intervention|
16243623|NCT01056991|Other|warming mattress|comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
16243624|NCT01056991|Other|warming blanket|
16243625|NCT01056965|Drug|davunetide (AL-108, NAP)|Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with davunetide 15 mg administered intranasally.
16243626|NCT01056965|Drug|Placebo nasal spray|Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with placebo administered intranasally.
16243627|NCT01056952|Procedure|O2stand|Standard low flow oxygen therapy (O2stand). The patients will receive oxygen delivered through a face mask. The FiO2 will be adjusted in order to obtain a SaO2 > 90%. The FiO2 will be determined by a portable oxygen analyzer (MiniOX I; Mine Safety Appliances Co, Pittsburgh, Pa)
16243628|NCT01056952|Procedure|CPAP|o Continuous positive airway pressure (CPAP). CPAP will be set at 7.5 cmH2O. Airway humidification will be achieved by using a heated humidifier (MR640; Fisher & Paykel, Auckland, NZ). The FiO2 will be adjusted in order to obtain a SaO2 > 90%. A facial mask composed of a transparent mask and a soft inflatable will be used
16243629|NCT01056952|Procedure|Optiflow|High flow oxygen nasal therapy (Optiflow). The flow will be set at 40l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SaO2 > 90%
16243630|NCT01056939|Device|Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)|Treatment with neurally adjusted ventilatory assist
16243631|NCT01056939|Device|Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)|Treatment with PC or PRVC ventilation.
16243632|NCT01056926|Behavioral|Quit smoking|Subjects will quit smoking for 2 fMRIs, each abstinence lasting 2 days
16243633|NCT01056926|Drug|Nicotine patch|Subjects will wear a 21mg patch for 2 fMRIs, each condition lasting 2 days. They will take the patch off at night.
16243634|NCT01056926|Drug|Placebo Patch|Subjects will wear a placebo patch for 2 fMRIs, each condition lasting 2 days. They will take the patch off at night.
16243635|NCT01056913|Device|Compression Anastomosis Device|Restoring intestinal continuity using the NITI CAR27 device
16243636|NCT01056913|Other|follow-up colonoscopy|endoscopic exploration of anastomosis after complete healing
16243637|NCT01056900|Procedure|Autologous Chondrocyte Implantation|"Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial)
~Directions and dosage:
~Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected."
16243638|NCT01056874|Drug|Digoxin|Oral Digoxin 0.25 mg single dose
16243639|NCT01056874|Drug|Digoxin|Oral Digoxin 0.25 mg single dose on Day 5
16243640|NCT01056874|Drug|Maraviroc|Oral Maraviroc 300 mg twice daily for 6 days
16243641|NCT01056861|Drug|Botulinum Toxin A|Not exceeding a total dose of 400 units, once every three months.
16243642|NCT01056835|Drug|prostaglandin I2 analogue|
16243643|NCT01056822|Drug|1|Continue with same dose of MMF as patient was taking before randomisation
16243644|NCT01056822|Drug|2|Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours
16243645|NCT01056809|Procedure|Chemotherapy and surgery|Treatment not specified but in accordance with national guidelines
16243646|NCT01056796|Device|CAR™ 27|Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
16243647|NCT01056783|Drug|OC000459|OC000459 100mg, twice daily, tablet
16243648|NCT01056783|Drug|Placebo|Placebo tablets to match OC000459 tablets, twice daily
16243649|NCT01056770|Drug|smallpox vaccine CJ-50300|Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
16243650|NCT01056757|Drug|Ribavirin|1000 mg bid, po, q28days
16243651|NCT01056744|Device|Percutaneous coronary intervention with stent implantation|"Percutaneous coronary intervention with implantation of either:
~- a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group),
~or:
~- a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group)"
16243652|NCT01056731|Drug|Aliskiren and HCTZ|Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
16243653|NCT01056718|Drug|Nebivolol|Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.
16243654|NCT01056705|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
16243655|NCT01056705|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
16243656|NCT01056705|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
16243657|NCT01056705|Biological|Oral Poliomyelitis Vaccine|Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
16243658|NCT01056705|Biological|Inactivated Poliomyelitis Vaccine (Salk strains).|3x0.5ml intramuscular injections, one month apart.
16243659|NCT01056692|Drug|OC000459|Capsules twice daily for 15 days
16243660|NCT01056692|Drug|Placebo|Capsules twice daily for 15 days
16243661|NCT01056679|Drug|Doxorubicine|50mg/m2 day 1 + 15
16243662|NCT01056679|Drug|DTIC|375mg/m2 day 1 + 15
16243663|NCT01056679|Drug|Lenalidomide|day 1 - 21
16243664|NCT01056679|Drug|Vinblastine|6mg/m2 day 1 + 15
16243665|NCT01056666|Device|Conveen Optima is a urisheath to be used together with a collecting bag for urine|Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis
16243666|NCT01056666|Device|absorbent protection|The patient use his usual absorbent protection (same brand), and change it when needed
16243667|NCT01056653|Behavioral|Standard Dose|Two intevention home visits
16243668|NCT01056653|Behavioral|High Dose|Four intervention home visits
16243669|NCT01056653|Behavioral|Comparison Group|One home visit, information only
16243670|NCT01056640|Device|Intel Health Guide|The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
16243671|NCT01056640|Other|Usual Care|The usual care intervention will include appropriate primary care and specialty office practice visits as required.
16243672|NCT01056627|Drug|Divalproex Sodium|Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
16243673|NCT01056614|Drug|fludarabine phosphate|Given IV
16243674|NCT01056614|Drug|busulfan|Given IV
16243675|NCT01056614|Biological|anti-thymocyte globulin|Given IV
16243676|NCT01056614|Drug|tacrolimus|Given IV and orally
16243677|NCT01056614|Drug|methotrexate|Given IV
16243678|NCT01056614|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
16243679|NCT01056614|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplant
16243680|NCT01056614|Other|laboratory biomarker analysis|Correlative studies
16243681|NCT01056601|Drug|Bortezomib|1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period
16243682|NCT01056601|Drug|Panobinostat|20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period
16243683|NCT01056588|Behavioral|CO-Contingent|In this 42 day condition, participants will receive monetary reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking (4ppm).
16243684|NCT01056588|Behavioral|Control condition|In this condition, participants will receive monetary reinforcement for timely breath samples with no contingency for a specific breath CO level
16243685|NCT01056575|Drug|OC000459|OC000459 100mg tablet, twice daily
16243686|NCT01056549|Drug|exenatide|In each study, the subjects will receive s.c. injection of either exenatide or matched placebo, in the Metabolic Testing Center and 2 hours prior to the start of the lipoprotein turnover study. Subjects will be blinded with regard to the treatments.
16243687|NCT01056536|Behavioral|Structured intervention for the prevention of sexually transmitted infections (STI).|The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms.
16243688|NCT01056536|Device|Free condoms|Subjects will be proposed free condoms at the end of the pre-travel consultation.
16243689|NCT01056523|Drug|Ribavirin|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID
16243690|NCT01056523|Drug|Cytarabine arabinoside|Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
16243691|NCT01056510|Drug|bendamustine|90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
16243692|NCT01056510|Drug|chlorambucil|10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles
16243693|NCT01056510|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
16243694|NCT01056497|Drug|alpha lipoic acid|A 2 week treatment period with either oral ALA tablets or placebo tablets, followed by 30 hour hospital stay to infuse lipid or saline and to test insulin sensitivity and insulin secretion. For two weeks prior to each admission to hospital and during each hospital admission subjects will ingest 3 tablets 2 times per day with breakfast and supper, 1800mg per day
16243695|NCT01056484|Behavioral|Mindfulness Based Relapse Prevention for Alcohol Dependence|"All subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. Experimental subjects also receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. The intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the study."
16243696|NCT01056484|Other|"Wait-list control"|'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC.
16243697|NCT01056471|Other|Autologous mesenchymal stem cells from adipose tissue.|Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
16243698|NCT01056471|Other|Autologous mesenchymal stem cells from adipose tissue.|Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
16243699|NCT01056458|Other|auricular acupressure|use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste.
16243700|NCT01056458|Other|sham acupressure|use only tape without ear adhesive beads under the same ways
16243701|NCT01056445|Procedure|valsalva maneuver|valsalva maneuver after carotid stenting
16243702|NCT01056445|Procedure|valsalva maneuver|valsalva maneuver after carotid stenting
16243703|NCT01056419|Procedure|Total Thyroidectomy|Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
16243704|NCT01056419|Drug|Propylthiouracil|150-600 mg in two-three divided doses
16243705|NCT01056406|Behavioral|Nutrition Education|Twice monthly interaction with study nutritionist (a registered dietitian) in the form of face-to-face individual nutrition counseling sessions, telephone and electronic follow-ups, option to attend group nutrition and group exercise classes.
16243706|NCT01056393|Drug|ibalizumab 800mg Q2Weeks|Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg every 2 weeks.
16243707|NCT01056393|Drug|ibalizumab 2000mg Q4Weeks|Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 2000mg every 4 weeks.
16243708|NCT01056380|Drug|Nitazoxanide|Tablet, 500 mg with food twice daily for 5 days
16243709|NCT01056380|Drug|Placebo|Tablet, twice daily with food for 5 days
16243710|NCT01056341|Drug|Propranolol|Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
16243711|NCT01056341|Drug|Placebo|Treatment with placebo for 6 months
16243712|NCT01056328|Device|SJM Irrigated Cardiac Ablation System|Irrigated ablation catheter
16243713|NCT01056328|Device|FDA approved Open Irrigated RF Ablation System|Irrigated ablation catheter
16243714|NCT01056315|Drug|GRT3938Y|Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
16243715|NCT01056315|Drug|Placebo|Overencapsulated tablets of placebo, 16 weeks treatment.
16243716|NCT01056302|Procedure|Surgical repair of mandibular fractures|Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary. Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery. The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface. The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared. Real surgical outcome will be compared to the simulated surgical outcome using the proposed software tool.
16243717|NCT01056289|Drug|Desvenlafaxine Succinate Sustained-Release Formulation 50 mg|DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
16243718|NCT01056289|Drug|Desvenlafaxine Succinate Sustained-Release Formulation 25 mg|DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
16243719|NCT01056289|Drug|Placebo|DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
16243720|NCT01056276|Drug|Bendamustine|Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
16243721|NCT01056276|Drug|Bortezomib|"1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
~Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15"
16243722|NCT01056276|Drug|Dexamethasone|20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15
16243723|NCT01056263|Drug|axitinib: observational study|Non-interventional observational study
16243724|NCT01056250|Procedure|SILS cholangiography|intraoperative
16243725|NCT01056237|Drug|Multi-target therapy|Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
16243726|NCT01056237|Drug|Azathioprine|1.0-2.0mg/kg/d
16243727|NCT01056224|Drug|Remifentanil|A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
16243728|NCT01056211|Procedure|laser treatment|Starlux 300 Lux 1540nm Fractional laser hand piece
16243729|NCT01056211|Procedure|treatment without laser|Starlux 300 Lux 1540nm Fractional laser hand piece
16243730|NCT01056211|Procedure|laser treatment|Starlux 300 Lux 1540nm Fractional laser hand piece
16243731|NCT01056198|Drug|Santyl|2 mm Santyl applied once daily.
16243732|NCT01056198|Procedure|Control|Daily gauze and optional sharp debridement
16243733|NCT01056172|Drug|Peginterferon alfa-2a and Ribavirin|"PegIFN alfa-2a (PEgasys) 180 ug/week
~Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
~Treatment duration: 16 weeks"
16243734|NCT01056172|Drug|Peginterferon alfa-2a and Ribavirin|"PegIFN alfa-2a (PEgasys) 180 ug/week
~Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
~Treatment duration: 24 weeks"
16243735|NCT01056159|Drug|Albuterol dry powder inhaler|Albuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.
16243736|NCT01056159|Drug|Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)|Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.
16243737|NCT01056146|Behavioral|Internet-based Interacting Together Everyday: Recovery After Childhood TBI|Families in I-InTERACT will look through 10 web-sessions (like chapters) and participate in 10 family meetings focusing on education about traumatic brain injury, parenting skills, communication, behavior strategies, and stress management. Meetings will be conducted in their home using a computer hook-up with a trained therapist. Families will also be contacted two times per month by the counselor to discuss individual problems or concerns.
16243738|NCT01056146|Behavioral|Internet Resources Comparison|Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources. The resources are available for families to access as often as they choose.
16243739|NCT01056133|Other|Omega-3 capsules-Fish Oil|Patients will take 2 capsules (1.0 g each) of n-3 PUFA (0.82/0.44 g of EPA/DHA) daily x 12 months. Since n-3 PUFA supplementation can be a potential treatment for NASH and since BMI will be< 30 kg/m2 for all subjects, patients will be told to keep their lifestyle, diet and medication stable (unless medically necessary) for the study duration in order to minimize environmental effect on gene expression.
16243740|NCT01056120|Device|Pro Kinetic Energy bare metal stent|PCI
16243741|NCT01056107|Drug|ROSE-010|The study medication was used in 30 mcg, 100 mcg, and 300 mcg subcutaneous injections daily, depending upon study arm.
16243742|NCT01056107|Drug|Placebo|Placebo subcutaneous injection daily
16243743|NCT01056094|Drug|Lutein|Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week
16243744|NCT01056081|Other|Inspiratory muscle training|"The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).
~The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training."
16243745|NCT01056042|Drug|intramuscular depot medroxyprogesterone acetate|150 mg, Intramuscular, every 3 months
16243746|NCT01056042|Drug|ethinyl estradiol 30 micrograms, gestodene 75 micrograms|one tablet orally, everyday
16243747|NCT01056029|Drug|G-202|Thapsigargin is Pro-drug chemotherapy which will be administered by intravenous infusion over 1 hour on Days, 1, 2 and 3 of each 28 day cycle
16243748|NCT01056016|Other|ADHD Collaborative|This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales.
16243749|NCT01056003|Other|Endoscopy|observational endoscopy in all patients an EGD is planned anyway
16243750|NCT01055990|Biological|split-virion, non-adjuvanted H1N1 vaccine of 15 μg|The influenza A (H1N1) 2009 monovalent, (Split-virion)inactivated vaccine was developed by Shanghai Institute of Biological Products, and the seed virus was prepared from reassortant vaccine virus A/California/7/2009,distributed by the Centers for Disease Control and Prevention in the United States. This strain was recommended by the World Health Organization and obtained from the Chinese Food and Drug Administration.The vaccine adopted the assessment of experts, and formally accessed to the approval document number of production and new drug certificate issued by the Chinese Food and Drug Administration.
16243751|NCT01055990|Other|blood fix|The blood fix with a hemagglutination-inhibition titer of 1:80 or more than was collected from healthy persons who are inoculated with specific H1N1 vaccine
16243752|NCT01055964|Drug|Tacrolimus|
16243753|NCT01055951|Device|Solo MicroPump|30 days treatment days with an optional extension period of up to 6 month of treatment.
16243754|NCT01055938|Drug|Divalproex Sodium|Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
16243755|NCT01055925|Device|modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)|
16243756|NCT01055925|Device|Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing|
16243757|NCT01055912|Drug|Lixivaptan|Capsule. Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. One hundred (100) patients will be randomized to receive lixivaptan 100 mg once daily (QD) for 8 weeks. Fifty (50) placebo patients will receive matching oral placebo for 8 weeks.
16243758|NCT01055912|Drug|Placebo|Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.
16243759|NCT01055899|Biological|REGN88|Single SC Dose
16243760|NCT01055899|Biological|REGN88|Single SC Dose
16243761|NCT01055899|Biological|REGN88|Single SC Dose
16243762|NCT01055886|Drug|nicotine patch|Nicotine patch, 7-21 mg.
16243763|NCT01055886|Drug|placebo patch|placebo patch used from weeks 4-6
16243764|NCT01055873|Biological|A single blood sample (30 mL)|A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood. Cells and plasma were stored and kept frozen for additional biological evaluations
16243765|NCT01055847|Drug|Aztreonam for Inhalation (AI)|Aztreonam for Inhalation
16243766|NCT01055847|Drug|Placebo|Saline Placebo
16243767|NCT01055834|Drug|Eszopiclone 3 mg|"Group A Period I, Group B Period II:
~Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting >=10 hours.
~Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug.
~Group B Period III:
~Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast.
~Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast & the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration."
16243975|NCT01054313|Drug|Sirolimus (Rapamycin)|Starting dose 1 mg daily by mouth 1 time a day.
16243768|NCT01055834|Drug|Eszopiclone 1 mg|"Group A Period II, Group B Period I:
~Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours.
~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
16243769|NCT01055821|Drug|pegylated interferon and ribavirin|48 weeks
16243770|NCT01055821|Biological|TG4040 + SOC|6 injections
16243771|NCT01055821|Biological|TG4040 + SOC|13 injections
16243772|NCT01055808|Drug|Insulins|Individual dose and frequency and duration as determined by the treating physician
16243773|NCT01055795|Drug|Bevacizumab, Everolimus and LBH589|"Dose Escalation Cohort #, Subjects, Bevacizumab, Everolimus, LBH589
~3-6, All study drugs administered per dose level
~3-6, All study drugs administered per dose level
~3-6, All study drugs administered per dose level
~Expanded Cohorts Cohort #, Subjects, Bevacizumab, Everolimus, LBH589 A, B & C; 30, Recommended Phase II Dose for all three compounds"
16243774|NCT01055782|Device|Endoguide|Use of endoguide to facilitate completion of endoscopy
16243775|NCT01055769|Drug|Linezolid|"Linezolid OS 600 MG
~Linezolid Tablet 600 MG"
16243776|NCT01055769|Drug|Linezolid|"Linezolid Tablet 600 MG
~Linezolid OS 600 MG"
16243777|NCT01055756|Drug|Loratadine + Pseudoephedrine sulfate|Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)
16243778|NCT01055743|Procedure|Radical resection|Radical resection of hepatocellular carcinoma
16243779|NCT01055743|Drug|Fluorouracil Implants|Implanted during the surgical treatment
16243780|NCT01055730|Other|Pulmonary rehabilitation|Structured education and supervised exercise program, lasting between 6 and 9 weeks.
16243781|NCT01055717|Other|Avenanthramide-enriched oats|Single dose, 24 hour pharmacokinetic trial
16243782|NCT01055704|Drug|Methylnaltrexone only|0.30 mg/kg subcutaneous injection daily
16243783|NCT01055704|Drug|Codeine only|30 mg taken orally four times daily for 5 days
16243784|NCT01055704|Drug|Methylnaltrexone + codeine|Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days
16243785|NCT01055704|Drug|Placebo + placebo|Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days
16243786|NCT01055691|Drug|Dapagliflozin/Metformin|Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
16243787|NCT01055691|Drug|Dapagliflozin|dapagliflozin tablet 2.5 mg Oral Single dose
16243788|NCT01055691|Drug|Metformin|metformin IR tablet 850 mg Oral Single dose
16243789|NCT01055691|Drug|Dapagliflozin/Metformin|Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
16243790|NCT01055691|Drug|Dapagliflozin|dapagliflozin tablet 5 mg Oral Single dose
16243791|NCT01055691|Drug|Metformin|metformin IR tablet 1000 mg Oral Single dose
16243792|NCT01055678|Drug|EF5|An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.
16243793|NCT01055678|Procedure|Partial or Total Mastectomy|A small tissue sample will be removed from the excised tissue and will be stored for later analysis.
16243794|NCT01055665|Other|cognitive behavior therapy|6 cognitive behavior therapy groups
16243795|NCT01055652|Drug|Dapagliflozin|10mg, oral, once daily
16243796|NCT01055639|Behavioral|In-Person ACT|8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
16243797|NCT01055639|Behavioral|Telehealth ACT|8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
16243798|NCT01055613|Device|Vistakon Investigational Multi-Purpose Solution I|Multi-purpose contact lens care solution.
16243799|NCT01055613|Device|ReNu MultiPlus Multi-Purpose Solution|Multi-purpose contact lens care solution
16243800|NCT01055600|Drug|eltrombopag|Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.
16243801|NCT01055561|Other|Acupuncture|Participators will be stimulated at specific acupuncture points as determined for the disease by the professional acupuncturists, and acupuncture once a day,last for one week.
16243802|NCT01055535|Drug|Microplasmin|125 µg intravitreal injection
16243803|NCT01055522|Drug|Arm 1: L19IL2 + Dacarbazine|"RD of L19IL2 determined in phase IIa. Induction Phase A: Intravenous (IV) infusion of L19IL2 on days 1, 3 and 5 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles.
~Induction Phase B: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles.
~Maintenance: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for a maximum of 1 year after start of treatment.
~DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first"
16243804|NCT01055522|Drug|Arm 3: Dacarbazine|Dacarbazine Dosage: 1,000 mg/m2 DTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first.
16243805|NCT01055522|Drug|ARM 2: L19IL2 + Dacarbazine|"RD of L19IL2 determined in phase IIa. Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for for a maximum of 1 year after start of treatment.
~DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first"
16243806|NCT01055509|Behavioral|Cognitive Adaptation Training|All patients receive treatment as usual. Additionally, patients in the intervention arm receives training concerning solving concrete problems related to the patient's daily life using tools such as schedules, schemes and signs. Additional the patient can receive SMS messages or instructions for the use of schedules in cell-phones to prompt for activities. The intervention is conducted in the patients homes every 14th day in a period of six months.
16243863|NCT01055197|Radiation|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
16243976|NCT01054313|Drug|Prednisone|5 mg by mouth twice a day with prostate cancer.
16243807|NCT01055496|Drug|inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone|"Day 1:
~Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg)
~Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4)
~Days 1-5:
~Prednisone at 40 mg/m2
~Each cycle is 3 weeks, with a maximum of 6 cycles total."
16243808|NCT01055496|Drug|inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone|"Day 1:
~Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5)
~Day 2:
~Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5)
~Days 1-4:
~Dexamethasone at 40 mg
~Each cycle is 3 weeks, with a maximum of 6 cycles total."
16243809|NCT01055483|Drug|panobinostat/LBH589B|
16243810|NCT01055470|Drug|Diclofenac|Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.
16243811|NCT01055470|Drug|Lornoxicam|Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
16243812|NCT01055457|Device|Vistakon Investigational Multi-Purpose Solution II|contact lens care solution
16243813|NCT01055457|Device|ReNu MultiPlus Multi-Purpose Solution|contact lens care solution
16243814|NCT01055444|Drug|Heated lidocaine and tetracaine topical patch|Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
16243815|NCT01055431|Other|Control bread|Control bread
16243816|NCT01055431|Other|Teff Bread|Teff bread
16243817|NCT01055418|Dietary Supplement|Vitamin C|Vitamin C will be administered at a dose of 1000mg. There will be at least a 48 hour wash out period between both conditions (placebo and vitamin C), with the order dicteted by Latin square.
16243818|NCT01055405|Drug|Sildenafil|Sildenafil 20mg TID orally
16243819|NCT01055405|Other|Placebo|Placebo TID orally
16243820|NCT01055392|Drug|Lithium Carbonate|lithium carbonate tablets, 150 mg to 450 mg (target serum lithium level 0.25 mEq/L - 0.5 mEq/L), divided in two doses, two years.
16243821|NCT01055392|Drug|Placebo|Identical placebo tablets were administered twice-a-day for two years.
16243822|NCT01055379|Drug|Rasagiline|1 mg/day for 12 weeks; orally
16243823|NCT01055379|Drug|Placebo|Once daily for 12 weeks; orally
16243824|NCT01055366|Drug|Elazop (Azarga)|Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
16243825|NCT01055340|Drug|Oxyntomodulin (OXM)|Single infusion of OXM 3.0 pmol/kg/min by IV
16243826|NCT01055340|Drug|Comparator: Oxyntomodulin (OXM)|Single infusion of OXM 0.6 pmol/kg/min by IV
16243827|NCT01055340|Drug|Comparator: Placebo [ hemaccel-containing saline]|Single Placebo infusion of hemaccel-containing saline by IV
16243828|NCT01055327|Drug|Lamotrigine monotherapy|Exposure to lamotrigine monotherapy in the first trimester of pregnancy (time period from first day of menstrual period to 12th week of gestation).
16243829|NCT01055327|Drug|No anti-epileptic drug exposure|No exposure to anti-epileptic drugs in the first trimester of pregnancy (time period from first day of menstrual period to 12th week of gestation).
16243830|NCT01055327|Drug|Non lamotrigine anti-epileptic drug monotherapy|Exposure to non lamotrigine monotherapy (with or without valproate) during the first trimester of pregnancy (time period from the first day of the menstrual period to the 12th week of gestation)
16243831|NCT01055314|Biological|Cixutumumab|Given IV
16243832|NCT01055314|Drug|Cyclophosphamide|Given IV
16243833|NCT01055314|Biological|Dactinomycin|Given IV
16243834|NCT01055314|Drug|Doxorubicin Hydrochloride|Given IV
16243835|NCT01055314|Drug|Etoposide|Given IV
16243836|NCT01055314|Drug|Ifosfamide|Given IV
16243837|NCT01055314|Drug|Irinotecan Hydrochloride|Given IV
16243838|NCT01055314|Other|Laboratory Biomarker Analysis|Correlative studies
16243839|NCT01055314|Drug|Temozolomide|Given PO
16243840|NCT01055314|Drug|Vincristine Sulfate Liposome|Given IV
16243841|NCT01055301|Drug|bortezomib|
16243842|NCT01055301|Drug|cisplatin|
16243843|NCT01055301|Drug|cyclophosphamide|
16243844|NCT01055301|Drug|dexamethasone|
16243845|NCT01055301|Drug|doxorubicin hydrochloride|
16243846|NCT01055301|Drug|etoposide|
16243847|NCT01055301|Drug|lenalidomide|
16243848|NCT01055301|Drug|melphalan|
16243849|NCT01055301|Drug|thalidomide|
16243850|NCT01055301|Genetic|gene expression analysis|
16243851|NCT01055301|Genetic|microarray analysis|
16243852|NCT01055301|Other|laboratory biomarker analysis|
16243853|NCT01055301|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|
16243854|NCT01055275|Device|Implantation with a Cook Iliac Branch Graft|Treatment of an aortic, aorto-iliac or iliac aneurysm with a CE-marked Cook Iliac Branch Graft.
16243855|NCT01055262|Device|Heatwrap 1|8 hours continuous topically-applied heat
16243856|NCT01055249|Drug|Ibuprofen, Hydrocortisone|Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
16243857|NCT01055249|Drug|Hydrocortisone|Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
16243858|NCT01055236|Drug|hydroxyzine|75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
16243859|NCT01055223|Drug|TZD only (RSG or PIO or troglitazone)|Drug exposure will be inferred from prescription claims. Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
16243860|NCT01055223|Drug|TZD + spironolactone|"Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
~In order to be eligible for inclusion in this category, the prescription days supply for TZD and spirinolactone must overlap by at least 30 days."
16243861|NCT01055223|Drug|TZD + amiloride|"Subjects who have been exposed to TZD for at least 6 months or at least 12 months will be considered for inclusion.
~In order to be eligible for inclusion in this category, the prescription days supply for TZD and Amiloride must overlap by at least 30 days."
16243862|NCT01055210|Device|Optimisation of VV delay|Programmed VV delay altered on device
16244069|NCT01053611|Drug|propofol + remifentanil 2 ng/ml|
16243864|NCT01055197|Radiation|Radiation Therapy|Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy
16243865|NCT01055184|Biological|2009 H1N1 Virus Vaccine|Single 0.2 mL dose of live monovalent vaccine, delivered through nasal spray
16243866|NCT01055171|Drug|Propranolol|40 mg; Single Administration.
16243867|NCT01055171|Drug|Placebo|40 mg; Single Dose.
16243868|NCT01055158|Behavioral|Telephone-based CBT|A form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes. All sessions begin with a depression rating and agenda setting and end with task assignments and summaries.
16243869|NCT01055158|Behavioral|Enhanced Usual Care|Participants randomized to this condition will be referred to receive in-person psychotherapy. Research study staff will help participants to set up their first appointment with a psychotherapist.
16243870|NCT01055145|Drug|levofloxacin, moxifloxacin|Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months
16243871|NCT01055132|Device|Etafilcon A toric contact lens|contact lens to correct astigmatism
16243872|NCT01055132|Device|Nelfilcon A toric contact lens|contact lens to correct astigmatism
16243873|NCT01055119|Dietary Supplement|Omega-3 fatty acids|duration: 4 month
16243874|NCT01055106|Drug|GW05|vaginal gel once daily regimen A
16243875|NCT01055106|Drug|GW05|vaginal gel once daily regimen B
16243876|NCT01055106|Drug|GW05|vaginal gel once daily regimen C
16243877|NCT01055106|Drug|Metronidazole|vaginal gel 0.75% once daily for 5 days
16243878|NCT01055080|Dietary Supplement|Cow's milk formula|Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life
16243879|NCT01055067|Drug|Tivantinib (ARQ 197)|Capsule, 120 mg, BID (360 mg), approximately 112 days
16243880|NCT01055041|Drug|inhaled budesonide and formeterol plus oral montelukast|1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening
16243881|NCT01055041|Drug|inhaled budesonide and formeterol plus oral doxophylline|1st two weeks -run in period, all participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet doxophylline sustained release(400 mg/day)orally in the morning
16243882|NCT01055041|Drug|Doubling the dose of inhaled budesonide and formeterol|1st two weeks -run in period, all groups participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day
16243883|NCT01055028|Drug|Bevacizumab|15 mg/kg, IV every 21 days x 6 cycles.
16243884|NCT01055028|Drug|Paclitaxel|"Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.
~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
16243885|NCT01055015|Drug|Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)|IR Capsules, flexible dose, every 4 to 6 hours
16243886|NCT01055015|Drug|Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)|One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose.
16243887|NCT01055002|Biological|Blood stage parasite (BSP) inoculum|Inoculum of human red blood cells infected with falciparum malaria administered intravenously on Day 1
16243888|NCT01054989|Biological|Fat/Inflammation effects|Fat infusion (Intralipid) over 6 hours Fat orally (Soy bean oil) single dose LPS infusion for 10 minutes Glycerol infusion over 6 hours
16243889|NCT01054976|Drug|Galantamine|Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.
16243890|NCT01054963|Behavioral|peer mentor training|A quasi-experimental, before and after study design is proposed to obtain data for planning and implementing a larger-scale study. A training workshop for individuals with IA to become peer mentors will increase peer mentors' confidence and skills to provide one-on-one support to individuals with EIA. Using a combination of lectures, experiential learning and question/answer sessions, peer mentors will learn and practice informational, emotional, appraisal support techniques and skills (communication skills, problem-solving strategies, use of decision tools). Training will be conducted face-to-face, in small-group format by research team and others (2 sessions approx. 5 hours each), in a private meeting room at SHSC. Peer mentors will then provide support to individuals newly diagnosed with IA for 12 weeks (once per week) by telephone and /or face-to-face. Peer mentors will receive ongoing support from the research team (telephone, meetings).
16243891|NCT01054950|Behavioral|Counseling|Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.
16243892|NCT01054950|Behavioral|Placebo phone call|Phone call w/ no behavioral counseling
16243893|NCT01054937|Drug|4SC-203|i.v. administration
16243894|NCT01054937|Drug|Placebo|i.v. administration
16243895|NCT01054911|Drug|Sunitinib|All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
16243896|NCT01054911|Procedure|Surgery|Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
16243897|NCT01054898|Behavioral|advocacy intervention|A 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women
16243898|NCT01054898|Behavioral|usual community services|standard care for abused women in the community
16243899|NCT01054885|Drug|FF Inhalation Powder|Inhaled Corticosteroid (ICS)
16243900|NCT01054885|Drug|FF/GW642444 Inhalation Powder|Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
16243901|NCT01054885|Drug|GW642444 Inhalation Powder|Long Acting Beta Agonist(LABA)
16243902|NCT01054885|Drug|Placebo|Placebo
16243903|NCT01054872|Biological|HIV-1 DNA plasmid vaccine|4 mg injection administered as 1 mL intramuscularly via Biojector in deltoid
16243904|NCT01054872|Biological|HIV-1 recombinant Ad5 vaccine|1 x 10^10 particle units (PU) administered as 1 mL intramuscularly by needle and syringe in deltoid
16243905|NCT01054859|Drug|avanafil|200 mg avanafil tablet QD plus 0.5 g/kg alcohol
16243906|NCT01054859|Other|alcohol|0.5 g/kg alcohol
16243907|NCT01054859|Drug|avanafil|200 mg avanafil tablet QD
16243908|NCT01054846|Other|Bicycle helmet from Bell Sports Inc.|As described under the respective arm
16243909|NCT01054846|Other|Bicycle helmet education only|As described under the respective arm
16243910|NCT01054833|Procedure|Needleless mid-urethral sling|The Needleless® sling is intended for use in women as a tension free, sub-urethral slings for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Needleless sling is a macroporous, monofilament, knitted polypropylene featuring 'Pocket Positioning Anchors' which allow sling placement without needle introducers; thus eliminating a complicated aspect of the surgery (TVT/TOT) and reducing the potential for bladder injury or inguinal pain that can occur during transobturator needle passage. The Needleless sling was approved by KFDA, and now is available in worldwide including Korea.
16243911|NCT01054820|Drug|FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%|One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
16243912|NCT01054807|Device|Galyfilcon A Habitual Lens|Comparison of three soft contact lens designs.
16243913|NCT01054807|Device|Galyfilcon A 8.7 BC (Investigational)|Comparison of three soft contact lens designs.
16243914|NCT01054807|Device|Galyfilcon A 8.3 BC (Investigational)|Comparison of three soft contact lens designs
16243915|NCT01054794|Device|Gastric mucosal stimulation|The lead is a sterile, 2mm diameter insulated wire (Temporary Transvenous Pacing Lead 6416-200cm, Medtronic, Minneapolis, MN) with 2 electrodes on the distal end. The mucosal stimulation parameters(Current:10 mA; Frequency: 14Hz; Pulse width: 330 ms; Cycle ON: 0.1 s; Cycle OFF: 5 s) are within the range used for standard permanent implanted GES (Enterra therapy) within the serosa and muscle layers of the stomach, and which has been shown to be safe, without any tissue damage.
16243916|NCT01054781|Drug|Rituximab|1st cycle R+R-CHOP 2-8th cycle R-CHOP
16243917|NCT01054768|Drug|alpha-lipoic acid and acetyl-L-carnitine|none to report
16243918|NCT01054768|Drug|Control|none to report
16243919|NCT01054742|Drug|Standard of Care PegIntron|Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).
16243920|NCT01054742|Drug|Standard of Care Ribavirin|Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.
16243921|NCT01054729|Drug|Sofosbuvir|Sofosbuvir tablet(s) administered orally once daily
16243922|NCT01054729|Drug|Placebo|Placebo to match sofosbuvir administered orally once daily
16243923|NCT01054729|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
16243924|NCT01054729|Drug|RBV|Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
16243925|NCT01054703|Device|Ethmoid Sinus Spacer|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
16243926|NCT01054690|Device|Bactiguard Infection Protection (BIP) Cathter.|
16243927|NCT01054690|Device|Silicone Urinary Catheter|
16243928|NCT01054677|Behavioral|Educational intervention on antibiotic prescribing|Small educational group sessions with nurses and physicians, feedback on prescribing, presentation of guidelines and written materials
16243929|NCT01054651|Drug|Artesunate+Sulfamethoxypyrazine/pyrimethamine|
16243930|NCT01054651|Drug|Praziquantel|
16243931|NCT01054638|Drug|HAART Treatment|"Using pharmacy records, identify all patients with HAART dispensing during baseline & follow-up periods. For combination medications, classify person-time according to individual therapeutic components. HAART exposure classification by 1)any HAART exposure, 2)by HAART class, and 3)by specific nucleoside reverse transcriptase inhibitor exposure. Specific evaluation of fosamprenavir and amprenavir.
~Subdivide person-time according to recent, past & non-use of HAART. Person-time for each patient partitioned into exposure windows of Recent use(From start of dispensing to end of days supplied plus 6 months), Past use(From end of current use to end of follow-up or new HAART dispensing following recent use), & Non-use(Time prior to first dispensing or all time for those who did not receive a dispensing).
~Determine cumulative duration of exposure based on days supplied per dispensing per patient over the baseline & follow-up periods: Non-use, Less than 1 yr, 1-2 yrs, More than 2yrs."
16243932|NCT01054625|Biological|zalutumumab|Zalutumumab is a clear to opalescent liquid. It is intended for intravenous infusion following dilution in sterile, pyrogen free, 0.9% NaCl. Patients will be treated at a specified dose of Zalutumumab over a period of 7 weeks. The dose will be 4mg/kg, 8mg/kg or 16mg/kg depending on when they enter the study. The study will begin with 6 patients on 4mg/kg, then 10 patients on 8mg/kg and lastly 10 patients on 16mg/kg.
16243933|NCT01054612|Other|Tissue Sectioning via Electro Erosion Process|Focused RF energy can be used to produce consecutive thin sections of fresh tissue for immunohistochemical and nucleic acids analysis by electro-dissociation without thermal damage, ultimately allowing high resolution reconstruction of gene and protein expression patterns of large tissue specimens in 3D.
16243934|NCT01054599|Drug|Memantine|All subjects in the treatment group will be placed on memantine. The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The dosing will increase slowly, to minimize the risk of side effects. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
16243935|NCT01054599|Other|Sugar Pill|In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine).
16243971|NCT01054352|Drug|JNJ38224342/placebo|one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo
16243972|NCT01054339|Drug|rAAV1-CB-hAAT|Recombinant adeno-associated virus vector expressing human alpha-1 antitrypsin
16243973|NCT01054326|Other|Exercises|
16243936|NCT01054599|Drug|Memantine|Open label: When the blinded phase is complete (Weeks 1-13), all subjects will receive open-label treatment with memantine (Weeks 14-26). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The dosing will increase slowly, to minimize the risk of side effects. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study. At the conclusion of the study, subjects will discontinue the treatment.
16243937|NCT01054586|Drug|Intervention A Standard dose|HIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of <2.0.
16243938|NCT01054586|Drug|Intervention B Reduced Dose|HIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD).
16243939|NCT01054586|Drug|Intervention C|HIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD.
16243940|NCT01054586|Drug|Intervention D|HIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0.
16243941|NCT01054586|Drug|Intervention E|HIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects.
16243942|NCT01054573|Drug|Telaprevir|750 mg orally every 8 hours (q8h) for 12 weeks
16243943|NCT01054573|Drug|pegylated interferon (Peg-IFN) alfa-2a|180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.
16243944|NCT01054573|Drug|ribavirin (RBV)|1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
16243945|NCT01054560|Device|SOLITAIRE™ Device|The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
16243946|NCT01054560|Device|MERCI® Device|The MERCI® Device is the control device that will be used in the interventional procedure.
16243947|NCT01054547|Drug|Ropivacaine|100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
16243948|NCT01054547|Drug|Ropivacaine|100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.
16243949|NCT01054534|Procedure|Placement of interstim lead|Placement of insterstim lead using US image fusion technology
16243950|NCT01054521|Procedure|Temperature-controlled RF|"The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.
~For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF."
16243951|NCT01054521|Device|Bipolar RF|The bipolar RF probe will be inserted at the same area with TCRF. The energy used will be 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
16243952|NCT01054508|Drug|nicotinic acid/laropiprant|Nicotinic acid/laropiprant (1g/20mg) daily for 4 weeks, then nicotinic acid/laropiprant (2g/40mg) daily for 8 weeks.
16243953|NCT01054495|Drug|Acupuncture|"The acupuncture needles are inserted in PC 6 bilaterally at the acupuncture point Pericardium 6 (PC6) on each forearm (fig 2). According to the cun measurement system of Traditional Chinese Medicine (TCM), the points are located on the palmar surface of anterior forearm at a distance equivalent to the combined width of the women's middle three fingers, proximal to the most prominent wrist crease, and between the tendons of palmaris longus and flexor carpi radialis. We try to keep the depth of the needling to approximately 1,5 cm. At insertion of the acupuncture needle, DeQi is obtained and the needle is then left without any further manipulation/ stimulation (even method) in situ for 15 minutes."
16243954|NCT01054495|Device|Sham acupuncture|A sham acupuncture needle is placed at PC 6 bilaterally and the tactile stimuli of the skin during the procedure should be obtained. The sham acupuncture needle is then left at site for 15 minutes without any further manipulation/stimulation.
16243955|NCT01054495|Device|Laser acupuncture|A laser is placed in a stand, pointing at PC 6 bilaterally, and left at site for 15 minutes without any further manipulation/stimulation.
16243956|NCT01054482|Drug|Pre-operative chemotherapy|Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
16243957|NCT01054482|Other|Pre-operative concurrent chemoradiation therapy|"Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles).
~Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx"
16243958|NCT01054469|Procedure|TAP block placement with placebo|20 ml of normal saline (placebo)
16243959|NCT01054469|Procedure|Placement of block with ropivacaine|20 ml of 0.5% ropivacaine hydrochloride
16243960|NCT01054456|Drug|palonesetron|One dose administered intravenously 30 minutes pre-chemotherapy
16243961|NCT01054443|Drug|Placebo|Tablet
16243962|NCT01054443|Drug|Lusutrombopag|Tablet
16243963|NCT01054430|Drug|avanafil|200 mg avanafil tablets QD
16243964|NCT01054404|Drug|Furosemide|Furosemide 0.3 mg/kg
16243965|NCT01054404|Drug|Placebo|Placebo (up to 5mL)
16243966|NCT01054391|Device|NEC - Neurovascular Embolization Cover|Implantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm
16243967|NCT01054378|Procedure|M-mode ultrasonography|Evaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine
16243968|NCT01054352|Drug|JNJ38224342|multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers
16243969|NCT01054352|Drug|JNJ38224342/placebo|up to four (4) additional cohorts consisting of healthy male volunteers may be added
16243970|NCT01054352|Drug|JNJ38224342/placebo|.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
16243977|NCT01054300|Drug|Ertugliflozin 2 mg single dose|Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
16243978|NCT01054300|Drug|Ertugliflozin 2 mg split into twice daily|Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
16243979|NCT01054300|Drug|Ertugliflozin 4 mg single dose|Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
16243980|NCT01054300|Drug|Ertugliflozin 4 mg split into twice daily|Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
16243981|NCT01054300|Drug|Placebo|Placebo to ertugliflozin administered as a single dose
16243982|NCT01054287|Other|Multifactorial falls prevention program|
16243983|NCT01054287|Other|No falls prevention intervention|
16243984|NCT01054274|Device|novel stent|Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
16243985|NCT01054274|Device|conventional covered stent|Patients undergo placement of a conventional covered stent on day 1.
16243986|NCT01054261|Drug|avanafil|200 mg avanafil tablet QD
16243987|NCT01054248|Drug|dihydroartemisinin-piperaquine|Standard 3 days regimen DHA-piperaquine: (DHA/PPQ 40 mg/320 mg) 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days
16243988|NCT01054248|Drug|Artesunate-mefloquine|Standard three day regimen of artesunate-mefloquine (12/24 mg/kg) given as artesunate 4mg/kg/day and mefloquine 8mg/kg/day on Days 0, 1 and 2.
16243989|NCT01054248|Drug|arthemeter-lumefantrin|Augmented 4 day regimen of artemether lumefantrine 2 doses per day for 4 days. Each dose consists of 5 tablets (20/120 mg of artemether/lumefantrine per tablet).
16243990|NCT01054235|Behavioral|training|The intervention consisted of 1) training township midwives, 2) informing women and men in the community of the importance of prenatal care, 3) providing intervention township hospitals with basic medical instruments used in prenatal care (i.e. blood pressure monitors, weighing scales for mothers and newborns, stethoscopes).
16243991|NCT01054222|Drug|Fesoterodine|Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)
16243992|NCT01054222|Drug|Fesoterodine|Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)
16243993|NCT01054209|Device|Warming with warming mattress|"Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.
~Inditherm Alpha systems, OTM1: 1900mm x 585mm"
16243994|NCT01054196|Drug|lenalidomide|daily dose dependent on dose-escalation schedule
16243995|NCT01054196|Drug|melphalan|100 mg/m2 given Days -2 and -1
16243996|NCT01054183|Device|GlideScope Ranger Intubation|Intubation with GlideScope Ranger Video Laryngoscope
16243997|NCT01054183|Device|Direct Laryngoscopy|Intubations will be done with direct laryngoscopy.
16243998|NCT01054170|Drug|AZD9668|2 x 30 mg oral tablets twice daily (bid) for 12 weeks
16243999|NCT01054170|Drug|Placebo|2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
16244000|NCT01054144|Drug|Lenalidomide|"Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
~Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
~Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
~Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
~Dose Level -4: Discontinue"
16244001|NCT01054144|Drug|Prednisone|"Starting Dose: 100 mg PO days 1-5 every 28 days;
~Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
~Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
~Dose level -3: Discontinue"
16244002|NCT01054144|Drug|Dexamethasone|"Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
~Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
~Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
~Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
~Dose level -3: Discontinue"
16244003|NCT01054131|Behavioral|peer support|A quasi-experimental, before and after study design will obtain data for planning and implementing a larger-scale study. Exposures and outcomes will be measured at baseline, 3 months (immediate post 12-week program) and 6 months (3 months post-program). Ten individuals with EIA will be recruited by brief screening interviews to ensure they meet inclusion criteria. Each pair of peer mentor and EIA participant will meet at SHSC for an initial contact. EIA participants will receive informational, emotional and appraisal support from trained peer mentors by telephone or neutral private location at a time convenient for both parties, at least once a week for 12 weeks.
16244004|NCT01054118|Drug|JNJ-38431055|Liquid suspension of JNJ-38431055 administered as a single dose
16244005|NCT01054118|Drug|Sitagliptin 100 mg|Capsule containing 100 mg of sitagliptin administered as a single dose
16244006|NCT01054118|Drug|JNJ-38431055 + Sitagliptin 100 mg|Liquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose
16244007|NCT01054118|Drug|Placebo|Placebo suspension and placebo capsule administered as single doses
16244008|NCT01054105|Drug|Iloprost|Iloprost inhalation, 2.5 - 5mcg, 6 times per day
16244009|NCT01054092|Drug|ipragliflozin|oral
16244010|NCT01054079|Other|laboratory biomarker analysis|Correlative study
16244011|NCT01054079|Procedure|quality-of-life assessment|Ancillary study
16244012|NCT01054079|Other|questionnaire administration|Ancillary study
16244013|NCT01054079|Drug|cinacalcet hydrochloride|Given PO
16244014|NCT01054066|Behavioral|Chronic Kidney Disease Education|Instituting teaching programs to manage hypertension, diabetes, anemia, proteinuria and cardiovascular disease in patients.
16244015|NCT01054040|Other|Portion plate given to cardiac rehabilitation patients|Patients in the experimental group will be provided with standard care (group and individual nutrition counselling) plus be provided a portion control plate
16244016|NCT01054027|Drug|1% phenylephrine and 0.2% cyclopentolate|given as drops, prior to eye exam
16244017|NCT01054014|Drug|JNJ-40346527/Placebo|Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo
16244018|NCT01054014|Drug|JNJ-40346527/Placebo|JNJ-40346527 once daily oral dose for 14 days (either 50, 150, 300, 500 or 750mg) or Placebo
16244019|NCT01054014|Drug|JNJ-40346527|JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting)
16244020|NCT01054001|Drug|sildenafil 100mg|sildenafil 100mg per oral twice a week
16244021|NCT01053988|Drug|FF/GW642444 Inhalation Powder|Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
16244022|NCT01053988|Drug|FF Inhalation Powder|Inhaled Corticosteroid (ICS)
16244023|NCT01053988|Drug|GW642444 Inhalation Powder|Long Acting Beta Agonist(LABA)
16244024|NCT01053988|Drug|Placebo|Placebo
16244025|NCT01053962|Drug|SP-304 0.3 mg|SP-304 0.3 mg
16244026|NCT01053962|Drug|SP-304 1.0 mg|SP-304 1.0 mg
16244027|NCT01053962|Drug|SP-304 3.0 mg|SP-304 3.0 mg
16244028|NCT01053962|Drug|SP-304 9.0 mg|SP-304 9.0 mg
16244029|NCT01053962|Drug|Placebo|Placebo
16244030|NCT01053949|Drug|Pomalidomide|Pomalidomide 4 mg continuous daily oral route on 21 days per 28 days cycle. The proposed dose of dexamethasone is considered standard, 40mg/day once a week.
16244031|NCT01053949|Drug|Pomalidomide|Pomalidomide 4 mg continuous daily oral route on 28 days of a 28 days cycle The proposed dose of dexamethasone is considered standard, 40mg/day once a week.
16244032|NCT01053936|Drug|Bardoxolone methyl (amorphous dispersion)|Oral, once daily
16244033|NCT01053923|Other|Magnetic Resonance Imaging (MRI)|This study involves three imaging sessions (Magnetic Nuclear Resonance -MRI), with one session before radiation therapy and two sessions during radiation therapy (one at 3 weeks of RT; the other during the last week of RT). Each imaging session will last for approximately 45 to 60 minutes.
16244034|NCT01053910|Drug|Ramipril|tablet of Ramipril once daily
16244035|NCT01053897|Biological|GBT009|Intradermal Injection following surgery
16244036|NCT01053897|Biological|Placebo|Intradermal Injection following surgery
16244037|NCT01053884|Drug|Anidulafungin|"standard dose: 200mg/d on day 1, followed by 100mg/d from day 2 as maintenance dose.
~Prophylaxis will be given until the recovery from neutropenia (ANC > 1,0 G/L without myelosupportive medications) and in cases of active fungal infection until best response, in case of fungemia for at least 2 weeks after the first negative culture."
16244038|NCT01053871|Drug|propofol|conscious sedation using propofol
16244039|NCT01053871|Drug|midazolam with fentanyl|conscious sedation using midazolam with fentanyl
16244040|NCT01053858|Procedure|intravitreal injection|intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
16244041|NCT01053845|Other|Neuropathic pain|to study the working of down inhibitor bundle at patients suffering of neuropathic pain
16244042|NCT01053832|Device|VpS algorithm in EVIA and ENTOVIS pacemakers|For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.
16244043|NCT01053819|Drug|etanercept|Patients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter.
16244044|NCT01053806|Drug|5-Azacytidine and Lenalidomide|Induction:5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days a cycle for 6 cycles and Lenalidomide 10mg/d orally days 6-28 every cycle for 6 cycles Consolidation: 5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days for 6 cycles Maintenance: Lenalidomide 10mg/d orally days 1-21 every cycle of 28 days for 13 cycles.
16244045|NCT01053793|Other|Glycemic response to different varieties of potatoes|the glycemic response top 50g available carbohydrates from 4 potato varieties will be compared to a 50g glucose standard
16244046|NCT01053780|Other|Intercessory Prayer|A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.
16244047|NCT01053780|Behavioral|Intercessory Prayer|A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.
16244048|NCT01053767|Biological|Group B streptococcus (GBS) vaccine|"No vaccine will be administered in this study. Only one study visit is required.
~Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study."
16244049|NCT01053754|Biological|"long synacthen stimulation test"|IM injection of 1 mg of delate synacthen which can be realized in ambulatory conditions
16244050|NCT01053741|Biological|Radiolabeled autologous seminal fluid|Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.
16244051|NCT01053741|Biological|Radiolabeled Normosol-R|Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.
16244052|NCT01053728|Drug|SAR161271|"Pharmaceutical form:Solution for injection
~Route of administration: subcutaneous"
16244053|NCT01053728|Drug|Insulin glargine HOE901|"Pharmaceutical form:Solution for injection
~Route of administration: subcutaneous"
16244054|NCT01053702|Drug|R475|IV
16244055|NCT01053702|Drug|Placebo|Placebo
16244056|NCT01053689|Drug|Glimepiride tablets 1 mg|
16244057|NCT01053676|Drug|Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule|BAY77-1931 Granule TID for 4 days
16244058|NCT01053676|Drug|Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet|BAY77-1931 Chewable tablet TID for 4 days
16244059|NCT01053663|Drug|Tamiflu|10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6
16244060|NCT01053650|Drug|Paracetamol|Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
16244061|NCT01053637|Drug|hydrocodone/acetaminophen|0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
16244062|NCT01053637|Drug|Sugar water|An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug
16244063|NCT01053624|Procedure|Tracheostomy|This protocol has been design to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications
16244064|NCT01053611|Drug|propofol + remifentanil 0 ng/ml|remifentanil 0 ng/ml
16244065|NCT01053611|Drug|propofol + remifentanil 2 ng/ml|
16244066|NCT01053611|Drug|propofol + remifentanil 4 ng/ml|
16244067|NCT01053611|Drug|propofol + remifentanil 6 ng/ml|
16244068|NCT01053611|Drug|propofol + remifentanil 0 ng/ml|
16244071|NCT01053611|Drug|propofol + remifentanil 6 ng/ml|
16244072|NCT01053611|Drug|propofol + remifentanil 0 ng/ml|
16244073|NCT01053611|Drug|propofol + remifentanil 2 ng/ml|
16244074|NCT01053611|Drug|propofol + remifentanil 4 ng/ml|
16244075|NCT01053611|Drug|propofol + remifentanil 6 ng/ml|
16244076|NCT01053585|Drug|Baclofen|Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
16244077|NCT01053585|Drug|Placebo|Placebo single 'dose' 90 minutes prior to study
16244078|NCT01053572|Procedure|Adhesiolysis|Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
16244079|NCT01053559|Drug|certolizumab pegol|400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
16244080|NCT01053546|Behavioral|exercise intervention|The early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
16244081|NCT01053546|Other|questionnaire administration|Ancillary study
16244082|NCT01053546|Procedure|quality-of-life assessment|Ancillary study
16244083|NCT01053533|Drug|Chinese herbal medicines plus western therapy|injections of Chinese herbal medicines and Chinese herbal medicines decoction& supportive therapy and antivirus therapy when necessary
16244084|NCT01053533|Drug|western therapy|supportive therapy and antivirus therapy when necessary
16244085|NCT01053520|Drug|ABT-263|Period 1: Single (oral) dose of 25 mg of Formulation A Period 2: Single (oral) dose of 25 mg of Formulation B1 Period 3: Single (oral) dose of 25 mg of Formulation B2
16244086|NCT01053520|Drug|ABT-263|Period 1: Single (oral) dose of 25 mg of Formulation B1 Period 2: Single (oral) dose of 25 mg of Formulation B2 Period 3: Single (oral) dose of 25 mg of Formulation A
16244087|NCT01053520|Drug|ABT-263|Period 1: Single (oral) dose of 25 mg of Formulation B2 Period 2: Single (oral) dose of 25 mg of Formulation A Period 3: Single (oral) dose of 25 mg of Formulation B1
16244088|NCT01053507|Drug|sumatriptan/naproxen sodium|Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.
16244089|NCT01053507|Drug|Placebo|Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.
16244090|NCT01053494|Procedure|massage therapy|Undergo massage therapy
16244091|NCT01053494|Other|questionnaire administration|Ancillary studies
16244092|NCT01053494|Procedure|quality-of-life assessment|Ancillary studies
16244093|NCT01053494|Other|intervention by caregiver|Undergo massage by caregiver
16244094|NCT01053494|Procedure|standard follow-up care|Undergo standard follow-up care
16244095|NCT01053481|Dietary Supplement|vitamin D|Vitamin D supplement
16244096|NCT01053481|Behavioral|exercise program (rebounding on a trampoline)|40 days at 30 min/d
16244097|NCT01053468|Behavioral|Physical Activity Resource Kit|"The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities.
~Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration)."
16244098|NCT01053468|Behavioral|Standard Materials|Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
16244099|NCT01053455|Device|SiPAP|biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP
16244100|NCT01053442|Dietary Supplement|Porridge fortified with either NaFeEDTA|265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.
16244101|NCT01053442|Dietary Supplement|FeSO4|Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.
16244102|NCT01053429|Drug|ziprasidone|This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
16244103|NCT01053416|Procedure|Yag laser iridotomy|the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt
16244104|NCT01053403|Drug|3,4-methylenedioxymethamphetamine or Placebo|1.5mg/kg MDMA or matched Placebo administered during 2 inpatients stays. There are 2 dosing sessions and all subjects will receive MDMA at least one time.
16244105|NCT01053390|Drug|Somatostatin|Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
16244106|NCT01053390|Drug|epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）|
16244107|NCT01053377|Drug|Tamiflu (verum)|
16244108|NCT01053377|Drug|Tamiflu placebo|
16244109|NCT01053364|Device|NL-Prow interspinous spacer implant|Interspinous spacer implant
16244110|NCT01053338|Drug|Ibuprofen and Diphenhydramine Citrate|Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
16244111|NCT01053325|Drug|Cotrimoxazole prophylaxis|Daily prophylaxis with cotrimoxazole
16244112|NCT01053325|Drug|SP IPT|Intermittent preventive treatment with sulphadoxine-pyrimethamine
16244113|NCT01053312|Drug|[18F] Flutemetamol|All subjects will receive an intravenous (IV) dose of [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels (MBq).
16244114|NCT01053299|Other|open, prospective cohort-study|Specific measurements from the X-ray to assess the hip status 5-12 years from the born.
16244115|NCT01053273|Procedure|Caudal Epidural Injection|Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
16244116|NCT01053273|Procedure|percutaneous adhesiolysis|Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
16244117|NCT01053260|Behavioral|LEARN Program|Participants will receive weekly counseling based on the LEARN Program for Weight Management
16244118|NCT01053260|Behavioral|Contingency Management|Participants can earn chances to win prizes for losing weight and completing activities that promote weight loss.
16244119|NCT01053247|Drug|0416|Topical 0416 test product applied twice daily for 2 weeks
16244120|NCT01053247|Drug|Vehicle of 0416 test product|Vehicle of 0416 test product applied twice daily for 2 weeks
16244121|NCT01053247|Drug|tacrolimus ointment 0.1%|Reference Product for 0416 test product. Apply twice daily for 2 weeks.
16244122|NCT01053234|Dietary Supplement|Standardised meals|
16244123|NCT01053221|Drug|Mycophenolic Acid|Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months
16244124|NCT01053221|Drug|Standard of Care: CNI and MPA|Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months
16244125|NCT01053208|Drug|Ibuprofen and Diphenhydramine Citrate|Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
16244126|NCT01053195|Behavioral|Lifestyle counseling|Non-diabetic high-risk subjects enrolled will be eligible for individual and/or group lifestyle counseling. The intervals of the counseling sessions depend on the glucose levels of the high-risk individuals, every three months for those having prediabetes and every six months for those with normal glucose levels but high risk score.
16244127|NCT01053182|Procedure|Ivor-Lewis Esophagectomy|Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
16244128|NCT01053182|Procedure|Sweet Esophagectomy|Esophagectomy through Left Side Thoracotomy
16244129|NCT01053169|Biological|Beriplex® P/N|Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
16244130|NCT01053169|Biological|Fresh Frozen Plasma (FFP) and Beriplex® P/N|FFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis.
16244131|NCT01053169|Other|Fresh Frozen Plasma|Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
16244132|NCT01053156|Drug|minocycline hydrochloride|Minocycline hydrochloride dosed orally once a day for 3 months.
16244133|NCT01053156|Drug|Placebo|Placebo will be given daily for 3 months.
16244134|NCT01053143|Biological|A/H1N1 pandemic influenza vaccine (non- adjuvanted)|0.5 mL, Intramuscular
16244135|NCT01053130|Procedure|laparoscopic sleeve gastrectomy|laparoscopic sleeve gastrectomy plus dietary and physical activity support
16244136|NCT01053130|Behavioral|weight management program|1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
16244137|NCT01053117|Other|Protocolized approach to convert dialysis catheter to fistula|This group will be assigned an algorithm protocol in efforts to convert the central venous catheter to an arteriovenous fistula. A case manager will be assigned to follow these patients and implement the protocol
16244138|NCT01053091|Behavioral|exercise|The trained subjects will be trained on a bicycle ergometer at about 60-70%of heart rate reserve for 35-55 minutes (that will include 10-min warm-up, 15-35-min main exercise, and 10-min cool-down) per day, 3 days per week for 12 weeks
16244139|NCT01053078|Drug|Naltrexone|1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
16244140|NCT01053078|Other|Placebo|1 month treatment; placebo tablet once daily for 28 days
16244141|NCT01053065|Drug|Atorvastatin - Cholestyramine - Sitosterol|
16244142|NCT01053052|Device|Sonography with FemVue, and HSG|Sono HSG for FDA 510(k) cleared indication for use
16244143|NCT01053039|Drug|Intrathecal Morphine|Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
16244144|NCT01053039|Drug|Intrathecal Saline|The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
16244145|NCT01053026|Drug|olmesartan|(1) Olmesartan treatment or (2) Life modification and exercise training
16244146|NCT01053013|Biological|RENCA macrobeads|
16244147|NCT01053000|Drug|Tazorac|compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment with Tazorac vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
16244148|NCT01052987|Drug|Tranilast|Tranilast tablets, 300 mg, QD
16244149|NCT01052987|Drug|Allopurinol|Allopurinol tablets 300 mg, QD
16244150|NCT01052987|Drug|Combination - Tranilast and Allopurinol|Tranilast, 300 mg QD; Allopurinol 300 mg QD
16244151|NCT01052987|Drug|400 mg Allopurinol|400 mg Allopurinol administered once daily for 7 days
16244152|NCT01052987|Drug|High dose combination|Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days
16244153|NCT01052974|Drug|ropivacaine|"A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection of local anesthetic with the technique of the femoral or iliofascial block.
~Intervention: Analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo."
16244154|NCT01052961|Drug|Oseltamivir|oseltamivir 150 mg bd for 5 days
16244155|NCT01052948|Other|Retrospective study-|
16244156|NCT01052948|Other|Retrospective study-|
16244157|NCT01052948|Other|Retrospective study-|
16244158|NCT01052948|Other|Retrospective study-|
16244159|NCT01052935|Biological|Group B streptococcus (GBS) vaccine|"No vaccine will be administered in this study. Only one study visit is required.
~Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study."
16244160|NCT01052922|Other|3 sample g-SENSA|Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
16244161|NCT01052922|Other|2 sample InSure|Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
16244162|NCT01052922|Other|1 sample OC-Micron|Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
16244163|NCT01052909|Drug|Glimepiride|Glimepiride tablets 1 mg
16244164|NCT01052896|Drug|Gabapentin|300mg po TID
16244165|NCT01052896|Drug|Placebo|Look-alike of gabapentin 300mg given po tid
16244166|NCT01052883|Drug|DRV commercial formulation/ DRV new formulation/ rtv 100mg tab|DRV two 400 mg commercial formulation tablets in the morning of day 3 fasting + rtv 100 mg 1/day on Day 1-5 [Treatment C], then after 7 days off treatment start DRV 800 mg new formulation in the morning of day 3 fasting + rtv 100 mg 1/day on Day 1-5 [Treatment D]
16244167|NCT01052883|Drug|DRV commercial formulation/ DRV new formulation/ rtv 100mg tab|DRV 800 mg new formulation tablet/rtv 100mg tablet in the morning of Day 3 after food+ rtv 100 mg 1/day on Day 1-5 [Treatment B], then after 7 days off treatment start DRV two 400 mg commercial formulation tablets in the morning of day 3 after food + rtv 100 mg 1/day on Day 1-5 [Treatment A]
16244168|NCT01052883|Drug|DRV commercial formulation/ DRV new formulation/ rtv 100mg tab|DRV 800 mg new formulation in the morning of day 3 fasting + rtv 100 mg 1/day on Day 1-5 [Treatment D], then after 7 days off treatment start DRV two 400 mg commercial formulation tablets in the morning of day 3 fasting + rtv 100 mg 1/day on Day 1-5 [Treatment C]
16244169|NCT01052883|Drug|DRV commercial formulation/ DRV new formulation/ rtv 100mg tab|DRV two 400 mg commercial formulation tablets in the morning of day 3 after food + rtv 100 mg 1/day on Day 1-5 [Treatment A], then after 7 days off treatment start DRV 800 mg new formulation tablet in the morning of Day 3 after food + rtv 100 mg 1/day on Day 1-5 [Treatment B]
16244170|NCT01052870|Drug|Finasteride|Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)
16244171|NCT01052857|Procedure|acupuncture|acupuncture application
16244172|NCT01052844|Drug|Placebo|Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
16244173|NCT01052844|Drug|Gabapentin|Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
16244174|NCT01052831|Drug|Naltrexone|50-100 mg qd for 8 weeks
16244175|NCT01052831|Drug|Placebo|50-100 mg qd for 8 weeks
16244176|NCT01052805|Procedure|harvest nerve|harvest nerve from cadaveric donor and patients receiving nerve graft operation
16244177|NCT01052792|Drug|Naproxen Sodium|Naproxen Sodium Tablets 550 mg
16244178|NCT01052779|Drug|Ferumoxytol|IV Ferumoxytol
16244179|NCT01052779|Drug|Iron Sucrose|IV Iron Sucrose
16244180|NCT01052766|Procedure|PET/CT and BH PET/CT|First, fiducial markers will be placed and taped on the patient's lower chest/upper abdomen. This will allow for monitoring of chest motion during breathing. A BH-CT scan will then be acquired with clinical CT scan parameters used in nuclear medicine. A BH-PET scan (acquisition time: 6 min per bed position) will follow the BH-CT scan. BH-PET images will cover the whole thorax, which, on average, corresponds to 1-3 PET FOV's (~15 cm/FOV). Data for these 1-3 bed positions are acquired to cover the entire thorax. There will be no additional radiotracer injection for the BH-PET scan.
16244181|NCT01052727|Procedure|Laparoscopic Cholecystectomy|
16244182|NCT01052714|Behavioral|Lifestyle Balance|Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition
16244183|NCT01052701|Drug|Ribavirin|"Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)
~OR
~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
16244184|NCT01052701|Drug|Ribavirin plus Abacavir (ABC)|"Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
~OR
~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
~Plus
~Daily Abacavir 300 mg orally every 12 hours"
16244185|NCT01052688|Other|Maternal blood draw of 30 to 50ml|Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.
16244186|NCT01052662|Drug|Memantine|30mg/day Memantine orally everyday for 12 weeks
16244187|NCT01052662|Drug|Memantine|15 mg/day Memantine orally everyday for 12 weeks
16244188|NCT01052662|Drug|Placebo|Placebo orally everyday for 12 weeks
16244189|NCT01052649|Other|Blood sampling|
16244190|NCT01052636|Other|Interdisciplinary intervention program|The intervention program developed for this study included three components: geriatric consultation service, rehabilitation program, and discharge-planning service.
16244191|NCT01052623|Drug|Somatropin, Clonidine, L-Arginin-Hydrochloride, Estradiol valerate|1 mg Estradiol valerate with for two days before GH-testing pre pubertal girls older than 8 years and pre pubertal boys older than 10 years. L-Arginin-Hydrochloride in the vein (0.5 g/kg KG maximum dose 30g) over 30 minutes. Clonidine orally (0,075 mg/m2 BSA). Somatropin-NutropinAq subcutaneum,a single one shot (dose 0.03 mg/KG, daily, over five days).
16244192|NCT01052610|Drug|sublingual house dust mites allergen extract|Staloral 300 IR, Stallergenes, France
16244193|NCT01052610|Drug|placebo in sublingual applicator|placebo for Staloral 300 IR, Stallergenes, France
16244194|NCT01052597|Drug|curcumin|Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
16244195|NCT01052584|Drug|Chloroquine- P. vivax|Total of 25mg base per kg over 3 days (10 mg base/kg on Days 1 and 2, and 5 mg base/kg on Day 3)
16244196|NCT01052584|Drug|Artemether-Lumefantrine: P. vivax|administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage
16244197|NCT01052584|Drug|Artemether-lumefantrine: P. falciparum|administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine in a fixed dose combination at a dosage
16244198|NCT01052571|Procedure|lumbar transforaminal epidural injections|with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level
16244199|NCT01052558|Device|iStent Inject (GTS400)|Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
16244200|NCT01052558|Procedure|Cataract Surgery|Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
16244201|NCT01052545|Behavioral|Audit-Feedback|Applied as a post-prescription antimicrobial review based on established guidelines.
16244202|NCT01052519|Other|Goal directed fluid therapy|Fluid will be administered to reach maximal stroke volume during the intraoperative period.
16244203|NCT01052506|Drug|BIIB033|Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)
16244204|NCT01052506|Drug|Placebo|Single dose of placebo comparator (8 cohorts IV, 1 cohort SC)
16244205|NCT01052493|Drug|PP 1420|Single dose of PP 1420, administered subcutaneously at either 2mg, 4mg or 8mg.
16244206|NCT01052493|Drug|Placebo|0.9% saline
16244207|NCT01052480|Biological|Anti-Influenza Immune Plasma|2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
16244208|NCT01052480|Drug|Standard Care|All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.
16244209|NCT01052467|Drug|Xamiol® Gel|Once daily application for about 4 weeks
16244210|NCT01052454|Behavioral|Mindfulness-based stress reduction|Participants in the MBSR arm attend eight weekly classes.
16244211|NCT01052428|Drug|metoprolol succinate (Toprol XL)|Toprol XL 100 mg once a day for 2 years
16244212|NCT01052428|Drug|Placebo|Placebo 100 mg once a day for 2 years
16244213|NCT01052415|Behavioral|Cognitive behavioral sessions|Behavioral: Cognitive-behavioral, small group format sessions delivered in Chinese to service providers and HIV patients.
16244214|NCT01052402|Biological|H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation|Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360
16244215|NCT01052389|Drug|Aripiprazole|Patients allocated to aripiprazole will be prescribed daily oral dose of drug, based on individual response and side-effects. Suggested starting dose will be 10 mg/day and dose range will be 10-30 mg/day.
16244216|NCT01052389|Drug|Olanzapine|Patients allocated to olanzapine will be prescribed daily oral dose of drug, based on individual patients' response and side-effect burden. Suggested starting dose will be 5 mg/day and dose range will be 10-20 mg/day.
16244217|NCT01052389|Drug|Haloperidol|"Patients allocated to haloperidol FGA arm will be prescribed daily oral dose of drug, based on individual patients' response and side-effect burden.
~Suggested starting dose will be 1-3 mg/day and dose range 3-10 mg/day (chlorpromazine equivalents: suggested starting dose 50-100 mg/day; dose range 150-300 mg/day)."
16244218|NCT01052376|Device|Confocal endomicroscopy|
16244219|NCT01052363|Drug|Bevacizumab, CA4P|
16244220|NCT01052337|Drug|anaesthetics: sevofluorane|0.5%of sevofluorane with air
16244221|NCT01052324|Drug|Remifentanil|After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.
16244222|NCT01052311|Drug|Tredaptive (1 g extended release niacin+ 20 mg laropiprant)|Laropiprant (LRP; Merck & Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) once daily for the first 30 days. from day 31 to 90 it will be 2 g of extended-release niacin and 20 mg laropiprant once daily.
16244223|NCT01052311|Drug|Placebo|Placebo tablets once daily
16244224|NCT01052311|Drug|Tredaptive|Tredaptive 1 g [Laropiprant 20 mg(LRP; Merck & Co., Inc, Whitehouse Station, NJ, USA) and 1 g of extended-release niacin]from day 1 to 30 once daily. From day 31 to 90, the same but 2 g instead of 1 g of extended-release niacin.
16244225|NCT01052298|Drug|Ciprofloxacin (Cipro inhale, BAYQ3939)|32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
16244226|NCT01052298|Drug|Ciprofloxacin (Cipro inhale, BAYQ3939)|32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
16244227|NCT01052298|Drug|Ciprofloxacin (Cipro inhale, BAYQ3939)|48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
16244228|NCT01052298|Drug|Placebo|Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.
16244229|NCT01052285|Procedure|Transversus abdominis plane block|UL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline
16244230|NCT01052285|Procedure|Saline|UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose
16244231|NCT01052285|Procedure|Local infiltration|Ilioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose
16244232|NCT01052272|Drug|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
16244233|NCT01052272|Drug|Candesartan cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
16244234|NCT01052272|Drug|Allopurinol|The starting dose of Allopurinol is 300 mg daily.
16244235|NCT01052259|Drug|Deoxyspergualin|100mg/vial as active substance; Deoxyspergualin at 3-5 mg/kg/day by 1-3 iv infusion will be given once a day for 5 to 7 days each cycle every month; Total cycle treatment will be 6.
16244286|NCT01051921|Drug|Pegylated interferon|Pegylated interferon, 180 micrograms in 0.5 ml of solution injected subcutaneously (SQ) once per week, for up to 48 weeks. Packaged in single use syringes.
16244538|NCT01050062|Drug|Telmisartan 80mg|Combination tablet
16244236|NCT01052246|Drug|Fixed combination of clindamycin 1% + benzoyl peroxide 5%|Topical monotherapy with a fixed combination of 1% clindamycin and 5% benzoyl peroxide hydrating gel (Duac® Akne Gel, Stiefel Laboratorium GmbH, Offenbach, Germany). In order to provide standardized condition within the sample, the gel was applied on the whole face regardless of the lesion location. The gel was applied once per day in the evening throughout the observation period and left in place overnight.
16244237|NCT01052246|Device|Pulsed dye laser|"Patients randomized in the experimental group received two additional treatments with a pulsed dye laser using the following parameters:
~Wavelength 585 nm
~Energy fluence 3 J/cm2
~Pulse duration 0.35 msec
~Spot size 7 mm"
16244238|NCT01052233|Procedure|Arthroscopic partial meniscectomy|Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
16244239|NCT01052233|Procedure|Arthroscopy (diagnostic)|Diagnostic arthroscopy of the knee
16244240|NCT01052220|Behavioral|BP education and BP self-regulation|"The intervention will consist of 3 phases: 1) BP education sessions, 2) 12 week intervention and 3) 30 day post intervention follow-up period. The participants in the treatment group will be asked to monitor and record home BP daily, 24 hour fluid intake and complete a salt intake check-lists twice weekly for 12 weeks.
~The PI will visit weekly with the intervention participants in the HD unit. to review BP and fluid logs and salt check lists with the participant to determine if predetermined goals for BP control were attained. When goals related to BP control are met, positive verbal reinforcement will be given to the participant. When goals related to BP control are not met, further exploration and problem solving will be done."
16244241|NCT01052220|Behavioral|Supportive Educative Nursing Intervention|BP Education, BP, salt and fluid monitoring, BP goal-setting, and reinforcement
16244242|NCT01052194|Drug|Placebo|tablet, placebo b.i.d. for 12 weeks
16244243|NCT01052194|Drug|VX-509|tablets, 25mg b.i.d. for 12 weeks
16244244|NCT01052194|Drug|VX-509|tablet, 50 mg b.i.d. for 12 weeks
16244245|NCT01052194|Drug|VX-509|tablet, 100 mg b.i.d. for 12 weeks
16244246|NCT01052194|Drug|VX-509|tablet, 150 mg b.i.d. for 12 weeks
16244247|NCT01052181|Drug|Cholecalciferol|Oral Cholecalciferol sachets 120,000 IU monthly for 1 year
16244248|NCT01052181|Drug|placebo|2 sachets monthly for an year
16244249|NCT01052168|Other|skills training|participants will train using different performance goals (based on different metrics)
16244250|NCT01052155|Other|Urine Drug Testing|LC/MS/MS Laboratory Evaluation
16244251|NCT01052142|Biological|Lipovaxin-MM|Patients will receive three doses of Lipovaxin-MM by intravenous infusion at intervals of four weeks OR patients will receive 4 doses of Lipovaxin-MM by intravenous infusion at weekly intervals
16244252|NCT01052129|Drug|Naproxen sodium|Naproxen Sodium Tablets 550 mg
16244253|NCT01052116|Drug|Soy isoflavone supplement|Oral soy isoflavone supplement (100 mg/day)
16244254|NCT01052116|Drug|Placebo|Placebo
16244255|NCT01052103|Drug|LY2140023|40 milligrams (mg), oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg.
16244256|NCT01052103|Drug|Placebo|Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.
16244257|NCT01052103|Drug|Standard of Care|United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)
16244258|NCT01052090|Drug|PHN121|a size 0 hard gel capsule containing 323.6 mg active ingredient, a complex mixture prepared from 5 commonly practiced botanical traditional Chinese medicines
16244259|NCT01052077|Drug|OPC-34712|Tablets, Oral, 1 - 3 mg OPC-34712
16244260|NCT01052077|Drug|Placebo|Placebo
16244261|NCT01052077|Drug|ADT|
16244262|NCT01052064|Device|Transcranial Magnetic Stimulation|rTMS will be administered in one daily session during 5 consecutive days of 1 Hz, 90% of motor threshold for a total of 1500 stimuli. The stimulation will be focal over left dorsolateral-prefrontal cortex(F3, from the international 10-20 system)
16244263|NCT01052051|Dietary Supplement|Vitamin D3|Vitamin D3 2000 IU/daily
16244264|NCT01052051|Dietary Supplement|Calcium carbonate|Calcium carbonate 1500mg / daily
16244265|NCT01052038|Drug|Placebo administration|Placebo administration
16244266|NCT01052038|Drug|Dexamethasone 0.05mg/kr administration|Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.
16244267|NCT01052038|Drug|Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.
16244268|NCT01052025|Drug|Curcumin|curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
16244269|NCT01052012|Drug|SABER-Bupivacaine|Injectable Extended Release Solution; SABER-Bupivacaine /Once
16244270|NCT01052012|Drug|Bupivacaine HCl|Injectable Solution; Bupivacaine HCl /Once
16244271|NCT01052012|Drug|SABER-Placebo|Injectable Solution; SABER-Placebo/Once
16244272|NCT01051999|Dietary Supplement|Glutamine|Oral glutamine powder
16244273|NCT01051999|Dietary Supplement|L-alanine|L-alanine oral powder
16244274|NCT01051986|Procedure|saphenous vein composite grafting|use saphenous vein as a composite graft connected to the left internal thoracic artery
16244275|NCT01051986|Procedure|right internal thoracic artery composite grafting|right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
16244276|NCT01051973|Behavioral|Cognitive behavior therapy|A 10-week treatment based on exposure to symptoms and related feelings.
16244277|NCT01051973|Behavioral|Stress management|A 10-week stress management treatment including applied relaxation and dietary advice.
16244278|NCT01051960|Drug|Ambrisentan|Ambrisentan 5mg or 10mg once daily
16244279|NCT01051947|Drug|Nebivolol|10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks
16244280|NCT01051947|Drug|Metoprolol|dosage prescribed prior to starting on study
16244281|NCT01051934|Drug|SS1 (dsFv) PE38|
16244282|NCT01051934|Drug|Paclitaxel|
16244283|NCT01051934|Drug|Carboplatin|
16244284|NCT01051934|Drug|Bevacizumab|
16244285|NCT01051921|Drug|CTS-1027|CTS-1027 supplied in 5 and 10 mg tablets, 15 mg taken twice daily, for up to 48 weeks
16244311|NCT01051700|Other|Placebo|Placebo
16244539|NCT01050062|Drug|Telmisartan 40mg|Combination tablet
16244287|NCT01051921|Drug|Ribavirin|Ribavirin, 200 mg capsules taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg for up to 48 weeks.
16244288|NCT01051895|Other|high risk HPV DNA testing|Specimens will be collected with a cervical cytobrush and cervical cells will be resuspended in 2 ml of Preservcyt® (Hologic LP), a liquid cytology preservation media. 75µl of processed sample will be hybridized with 25 µl of probe B mixture. The assay is completed as a standard enzyme immunoassay with the addition of a dioxetane-based chemiluminescent substrate. Specimens will be considered positive for HPV if the ratio of RLUs of the specimen to the mean RLUs of triplicates of positive control (at 1 pg per ml or 5000 copies of HPV genome per test) is at least one.
16244289|NCT01051895|Other|Active comparator: Routine colposcopy|Women will undergo colposcopy, with no standardized protocol; tests are left at the discretion of the treating physician, in order to document routine proactive. We will document all procedures (biopsies, endocervical curettage, cytology, etc) and their outcome.
16244290|NCT01051882|Biological|MSC-NTF cells transplantation (IM)|In early ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia, intramuscularly into patients' clinically unaffected (or only mildly affected) upper arm biceps and triceps muscles according to a pre-designed grid. Intramuscular injections will be by a 26 gauge needle to a 1.5cm depth (ensuring that injection is into muscle and not adipose tissue). The patients will be injected at 24 sites with a total of 24 million cells
16244291|NCT01051882|Biological|MSC-NTF cells transplantation (IT)|In progressive ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia intrathecally(via a standard lumbar puncture)with a total of 60 million cells.
16244292|NCT01051869|Procedure|Simple decompression|"Fracture fixation will be performed through a posterior approach, as this provides excellent visualization of the distal fragments. A triceps split will be used to expose the distal humerus. A midline incision will be made from proximally to distal onto the shaft of the ulna. Equal portions of the triceps muscle will be reflected medially and laterally, with use of sharp dissection to remove the triceps insertion from the olecranon. The ulnar nerve will be identified and protected proximal and distal to the medial epicondyle. Fracture fixation will be performed after anatomic reduction using standard fixation techniques and plate fixation on both the medial and lateral column.
~In the simple ulnar nerve decompression group, no further treatment of the ulnar nerve will be undertaken."
16244293|NCT01051869|Procedure|anterior subcutaneous transposition|In the anterior transposition of the ulnar nerve group, the ulnar nerve will be placed subcutaneously anterior to the medial epicondyle free from any pressure.
16244294|NCT01051856|Device|SEAMGUARD with bioabsorbable staple|In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
16244295|NCT01051856|Procedure|TissueLink with radiofrequency ablation|After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
16244296|NCT01051830|Other|Diabetes interdisciplinary program|Diabetes consulting, rehabilitation program
16244297|NCT01051817|Drug|AIN457|infusion 10 mg/Kg
16244298|NCT01051817|Drug|Placebo|infusion
16244299|NCT01051804|Other|Systane Ultra|Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
16244300|NCT01051804|Other|Optive lubricant Eye Drops|Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
16244301|NCT01051791|Drug|Everolimus 10mg daily|RAD001 is a pill that will be taken orally (by mouth), at a dose of 10 mg, once a day for 28 days.
16244302|NCT01051778|Drug|enoxaparin 40mg plus low dose aspirin|Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initiated. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop enoxaparin or UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID)) is started before conception and continued until 36 weeks gestation.
16244303|NCT01051778|Drug|Heparin calcium5,000 U twice daily plus low dose aspirin|Heparin Calcium 5,000 U twice daily (Cal-Heparine, Amoun Pharmaceutical Co, Egypt) by subcutaneous injection is started when the serum pregnancy test become positive. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID))is started before conception and continued until 36 weeks gestation .
16244304|NCT01051765|Drug|irinotecan/cisplatin|irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks
16244305|NCT01051739|Procedure|Comparison of four visual field testing strategies|We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm.
16244306|NCT01051726|Other|Aromatherapy oil|Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
16244307|NCT01051726|Other|None essential oil|Baby oil
16244308|NCT01051713|Behavioral|Technology Supported|Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
16244309|NCT01051713|Behavioral|Standard|"Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the Keeping Track form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits."
16244310|NCT01051700|Drug|GW786034|Investigational product
16244312|NCT01051687|Drug|Botulinum toxin A|"Dilution of 1 ml of unpreserved saline per 100 U vial of BOTOX (Allergen pharmaceuticals, Irvine, CA). 2 units were injected intradermally every 1 cm2 with a 1ml syringe and 30 gauge needle.
~For each patient with focal vitiligo, one vitiliginous patch - or two patches from different sites- will be treated. The other patches from the contra lateral site will be left untreated and used as control at the follow-up visit. For each patient with segmental vitiligo, half of the lesion will treated. The other half will be left untreated and used as a control at the follow-up visit."
16244313|NCT01051674|Other|High fiber vs. low-carbohydrate diets|High fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women.
16244314|NCT01051661|Biological|GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)|Intramuscular injection, one or two doses
16244315|NCT01051661|Biological|GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)|Intramuscular injection, two doses
16244316|NCT01051661|Biological|Placebo|Intramuscular injection, one dose
16244317|NCT01051648|Drug|Intra ocular injection of triamcinolone acetonide|In all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. It was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. The direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. Triamcinolone was removed as quickly & completely as possible after finishing anterior vitrectomy
16244318|NCT01051635|Drug|LMP 400|Indenoisoquinolines are non-camptothecin inhibitors of topoisomerase 1 with improved characteristics such as better chemical stability, producing stable DNA-top1 cleavage complexes, and exhibiting a preference for unique DNA cleavage sites compared with their camptothecin counterparts.
16244319|NCT01051635|Drug|LMP 776|Indenoisoquinolines are non-camptothecin inhibitors of topoisomerase 1 with improved characteristics such as better chemical stability, producing stable DNA-top1 cleavage complexes, and exhibiting a preference for unique DNA cleavage sites compared with their camptothecin counterparts.
16244320|NCT01051622|Other|Labeling Ceretec|Technetium-99m is used to radiolabel cells of interest i.e PBMC's
16244321|NCT01051609|Other|History and Physical Exam|The physical exam includes vital signs and ECOG performance status.
16244322|NCT01051609|Other|Grip Strength Measurement|A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
16244323|NCT01051609|Behavioral|Surveys|Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.
16244324|NCT01051609|Other|Blood Collection|A set of blood markers will be assayed at baseline, 6 months, and 12 months.
16244325|NCT01051609|Procedure|Ultrasound of Hand/Wrist|An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.
16244326|NCT01051596|Drug|Temozolomide|150mg/m2 Days 1-5 of each 28 day cycle
16244327|NCT01051596|Drug|ABT-888|40mg orally BID Days 1-7 of each 28 day cycle
16244328|NCT01051583|Procedure|Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin|The operative procedure involved retro-bulbar anesthesia, draping the patient in an aseptic manner, introduction of an eye speculum, 30 laser shots over 270 degrees of the circumference of the limbus. For our study we used the Iris Diode laser machine, the G-probe and we adjusted the settings for 2500 millisecond duration and the 3000 milli-joule and reduced the power progressively until just below the energy level that produced a pop.then after applying the laser, we performed a paracentesis with a 27 gauge needle to soften the globe, followed by intravitreal injection of the Avastin from a site 3.5 millimeter posterior to the limbus. The dose we administered was one milligram of bevacizumab (0.04 mL of 25 mg/mL).
16244329|NCT01051570|Drug|carboplatin|AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
16244330|NCT01051570|Drug|RAD 001|5 mg orally starting on Day 2 then continuous
16244331|NCT01051570|Drug|prednisone|5 mg orally twice a day starting on Day 1 then continuous
16244332|NCT01051570|Other|laboratory biomarker analysis|Samples will be collected from archival tissue.
16244333|NCT01051570|Other|pharmacological study|Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2
16244334|NCT01051557|Other|Laboratory Biomarker Analysis|Correlative studies
16244335|NCT01051557|Drug|Perifosine|Given PO
16244336|NCT01051557|Drug|Temsirolimus|Given IV
16244337|NCT01051557|Procedure|Therapeutic Conventional Surgery|Undergo cytoreductive surgery
16244338|NCT01051544|Drug|FVIII Concentrates|Patients will be centrally randomized to receive a von Willebrand factor-free FVIII concentrate (recombinant or plasma-derived, monoclonally-purified). The choice of product brand will be based on physician / patients preferences.
16244339|NCT01051544|Drug|FVIII/VWF concentrates|Patients will be centrally randomized to receive a FVIII/VWF concentrate of 200 IU/Kg by one or two bolus injections daily.The choice of product brand will be based on physician / patients preferences.
16244340|NCT01051531|Drug|Paliperidone palmitate|One intramuscular (IM) injection of paliperidone palmitate 150 mg equivalent (eq.) on Day 1, 100 mg eq. on Day 8, and 75 mg eq. on Day 38. Thereafter, one IM injection of paliperidone palmitate 50, 75, 100, or 150 mg eq. once monthly. Doses may be adjusted every 30 days per the clinician's judgment within the dose range of 50 to 150 mg eq.
16244341|NCT01051518|Device|Medtronic CoreValve System|Transcatheter Aortic Valve
16244342|NCT01051505|Drug|AZD5069|oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
16244343|NCT01051505|Drug|Placebo|oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
16244344|NCT01051479|Drug|C11-Choline|15 mCi 11C-choline will be administered intravenously as a bolus. The whole body emission scans will be acquired immediately following the tracer injection.
16244345|NCT01051466|Drug|Duloxetine|60 milligrams (mg) administered orally daily for 8 weeks then 60-120 mg if non remitter or 60 mg if remitter for 4 additional weeks
16244346|NCT01051440|Drug|Lisdexamfetamine|Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.
16244347|NCT01051440|Drug|Placebo|Subjects will receive placebo matched to lisdexamfetamine.
16244348|NCT01051427|Device|Surgiflo|Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.
16244349|NCT01051427|Device|Nasal catheter|In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.
16244350|NCT01051414|Drug|BMS-790052|Tablets, Oral, 60 mg, daily, 24 weeks
16244351|NCT01051414|Drug|BMS-650032|Tablets, Oral, 1200 mg, daily, 24 weeks
16244352|NCT01051401|Drug|rosuvastatin|Given PO
16244353|NCT01051401|Other|placebo|Given PO
16244354|NCT01051401|Other|survey administration|Correlative study
16244355|NCT01051401|Procedure|management of therapy complications|
16244356|NCT01051388|Drug|Low-dose PPI (Rabeprazole sodium)|PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
16244357|NCT01051388|Drug|High-dose PPI (Rabeprazole sodium)|PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
16244358|NCT01051388|Drug|Non-PPI (Gefarnate)|The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
16244359|NCT01051375|Behavioral|Psychoeducational Workshop and telephone support|The intervention involves completion of a single workshop (delivered by a psychiatrist and adolescent health physician), provision of psycho educational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list.
16244360|NCT01051362|Drug|PLD and Carboplatin|Pegylated liposomal doxorubicin (PLD) 30 mg/m2, followed by Carboplatin AUC (area under the curve) 5, every 21 days for 4 cycles or until progression.
16244361|NCT01051349|Biological|BIIB019 (Daclizumab)|Administered as specified in the treatment arm.
16244362|NCT01051349|Biological|trivalent seasonal influenza vaccine|All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
16244363|NCT01051336|Device|TARIS Placebo|
16244364|NCT01051336|Procedure|Sham Procedure|
16244365|NCT01051323|Drug|methoxy polyethylene glycol-ep [Mircera]|As prescribed by physician
16244366|NCT01051310|Device|Medtronic CoreValve System|Transcatheter Aortic Valve
16244367|NCT01051284|Radiation|Cyberknife radiation and gemcitabine|25 Gray of radiation will be given in 5 fractions using the Cyberknife Gemcitabine 1000 mg/m2 intravenously will be given once a week on days 1, 8, and 15 of every 28-day cycle for 6 cycles
16244368|NCT01051271|Drug|midazolam|midazolam 1.5 mg
16244369|NCT01051258|Device|AeriSeal System|AeriSeal System for Lung Volume Reduction
16244370|NCT01051245|Behavioral|Case manager counseling|Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets.
16244371|NCT01051245|Other|Usual care|Usual care provided by primary care physician and/or specialist according to patients' needs and professional criteria. Includes free access to educational diabetes workshops and educational brochures.
16244372|NCT01051232|Drug|Active|Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
16244373|NCT01051232|Drug|Placebo|Two subjects will receive the placebo under fasting condition.
16244374|NCT01051232|Drug|Active|Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
16244375|NCT01051232|Drug|Placebo|Two subjects will receive the placebo under fasting condition.
16244376|NCT01051232|Drug|Active|Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
16244377|NCT01051232|Drug|Placebo|Two subjects will receive the placebo under fasting condition.
16244378|NCT01051219|Drug|Losartan|50 milligrams to be taken orally, daily
16244379|NCT01051206|Drug|6% hydroxyethyl Stach 130/0.4|After dividing patients medicated with HES 130/0.4(maximum 33ml/kg/day) during surgery and one day after from the surgery with patients medicated with crystalloid only, compare the effect on the volume of bleeding, blood transfusion, and blood coagulation when using IV fluid.
16244380|NCT01051193|Drug|Oxcarbazepine|
16244381|NCT01051180|Procedure|HALO|Ligation of haemorrhoidal arteries
16244382|NCT01051167|Drug|Cetuximab|500 mg /m² cetuximab as an intravenous infusion over 120 minutes on day 1 every 2 weeks
16244383|NCT01051154|Dietary Supplement|Docosahexaenoic acid (DHA)|Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.
16244384|NCT01051154|Dietary Supplement|Placebo|Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.
16244385|NCT01051141|Behavioral|Computer-delivered Brief Intervention (CBI)|"The multimedia, interactive CBI condition will be delivered using touch-screen tablet computers with audio delivered via headphones. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant."
16244386|NCT01051141|Behavioral|Intervener-delivered Brief Intervention (IBI)|"The IBI condition will be delivered by a master's-level clinician with the aid of graphics. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant."
16244387|NCT01051141|Behavioral|Adapted Motivational Enhancement Therapy (AMET)|The AMET session will have a similar general outline (~45 minutes) to the BI in the ED, including a review of participants' goals and values, alcohol use and consequences, decisional balance exercises, and change plan.
16244388|NCT01051128|Device|Prometra Programmable Implantable Pump System|The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer.
16244389|NCT01051115|Drug|Dasatinib|Chemo-refractory CLL patients will be treated with dasatinib monotherapy 100mg daily.Patients with less than a partial response at 4 weeks will receive fludarabine (orally 40mg/daily for 3 days q28) in addition to dasatinib for a maximum of 6 cycles. Patients with at least a partial response will continue dasatinib monotherapy. Patients that receive monotherapy after the initial 28 days and that develop progressive disease will 'cross-over' to the combination treatment.
16244390|NCT01051102|Drug|insulin degludec/insulin aspart|Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
16244391|NCT01051102|Drug|biphasic insulin aspart 30|Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
16244392|NCT01051089|Behavioral|Lifestyle modification|Exercise and diet education
16244393|NCT01051076|Drug|VWF/FVIII concentrates|200 IU/Kg by one or two bolus injections daily. After successful confirmation the dose will be tailed off progressively until discontinuation. Patients will be treated with a VWF/FVIII concentrates according to physician/patients preference.
16244394|NCT01051063|Biological|GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A|Intramuscular injection
16244395|NCT01051050|Behavioral|Mandatory use of surgery wiki|Mandatory participation in the surgery wiki. This will include adding to and reviewing information posted on the wiki. Contribution of an evidence-based review will be required at least once during the study period.
16244396|NCT01051050|Behavioral|Voluntary use of the surgery wiki|Voluntary participation in the surgery wiki. Participants can choose to use the information in the wiki as well as contribute to the wiki.
16244397|NCT01051037|Radiation|Stereotactic Body Radiation|3 fraction of stereotactic body radiation therapy within 10 days.
16244398|NCT01051037|Radiation|Radiofrequency Ablation|Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
16244399|NCT01051024|Dietary Supplement|Diamel|Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
16244400|NCT01051024|Dietary Supplement|Placebo|Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
16244401|NCT01051011|Drug|insulin glargine|initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
16244402|NCT01051011|Drug|metformin|as prescribed
16244403|NCT01051011|Drug|taspoglutide|10mg sc weekly, 24 (-52) weeks
16244404|NCT01051011|Drug|taspoglutide|10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
16244405|NCT01050998|Biological|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.
16244406|NCT01050998|Biological|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.
16244407|NCT01050998|Biological|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.
16244408|NCT01050998|Biological|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.
16244409|NCT01050998|Other|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
16244410|NCT01050985|Drug|Temsirolimus and capecitabine|temsirolimus in escalating doses starting at 15-mg IV on days 1 and 8 of a 14 day cycle capecitabine in escalating doses starting at 1000 mg/m2 by mouth twice a day on days 1-7 of a 14-day cycle
16244411|NCT01050972|Behavioral|Behavioral: Cognitive, Relaxation, Exercise Therapy|Behavioral: Cognitive, Relaxation, Exercise Therapy The intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce hyperfunction of the craniofacial and cervical muscles during the day
16244412|NCT01050959|Device|bion|
16244413|NCT01050946|Biological|Haploidentical/cord transplant|"Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.
~Conditioning Regimens Choice of regimen at the discretion of the treating physician
~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)
~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)
~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
16244414|NCT01050933|Drug|250 ppm carbon monoxide|250 ppm of inhaled carbon monoxide over one hour
16244415|NCT01050920|Biological|Blood collection|
16244416|NCT01050907|Drug|Miltefosine|2.5 mg/kg/day for 28 days
16244417|NCT01050868|Device|Accu-Chek Combo Kit mg DE/de|
16244418|NCT01050855|Drug|RIC: Distal Campath|Campath, Fludarabine, Melphalan, Cyclosporine, Cellcept (MMF)
16244419|NCT01050855|Drug|RIC:Intermediate Campath|Campath, Fludarabine, Melphalan, Cyclosporine, Cellcept (MMF)
16244420|NCT01050855|Drug|RIC: Mini Busulfan|Campath, Fludarabine, Busulfan, Cyclosporine, Cellcept (MMF)
16244421|NCT01050842|Drug|bicalutamide|Given orally
16244422|NCT01050842|Drug|raloxifene|Given orally
16244423|NCT01050842|Procedure|quality-of-life assessment|Ancillary study
16244424|NCT01050829|Drug|Gadobutrol (Gadovist, BAY86-4875)|Single administration at a dose of 0.1 mmol/kg
16244425|NCT01050829|Drug|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Single administration at a dose of 0.1 mmol/kg
16244426|NCT01050816|Procedure|Chondron(autologous chondrocyte) Implantation|"Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial)
~Directions and dosage:
~Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.
~*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation."
16244427|NCT01050803|Behavioral|FDSME group|"In the intervention group, diabetes education sessions which are designed based on the Intervention Mapping will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions."
16244428|NCT01050803|Behavioral|FDSME|"In the intervention group, sessions which are designed based on the Intervention Mapping will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions."
16244429|NCT01050790|Drug|Azacitidine|Subject will receive Vidaza (azacitidine) and Revlimid (lenalidomide) as treatment for their multiple myeloma. The Vidaza will be given for 5 days as an injection. On day 6 they will receive Revlimid taken by mouth every day for 16 days followed by 7 days of rest. The drug cycle will be repeated 0, 1 or 2 more times depending on how their blood counts recover.
16244430|NCT01050777|Drug|Liposomal meglumine antimoniate (Glucantime)|Liposomes containing meglumine antimoniate
16244431|NCT01050777|Drug|Liposomal meglumine antimoniate|Liposomal form of meglumine antimoniate
16244432|NCT01050777|Drug|Liposomal Paromomycin|Liposomal form of 10% Paromomycin
16244433|NCT01050777|Drug|Placebo|Placebo
16244434|NCT01050764|Drug|Regulatory T-cells|"To ameliorate the impaired immune recovery and address the significant relapse incidence in the haploidentical setting. Cells will be selected by a tandem selection process and infused on day +14. These are the enriched but naturally-occurring regulatory T cells. Possible dose cohorts and levels are:
~Cohort 1
~T-reg: 1 x 10e5/kg
~T-con: 3 x10e5/kg
~Cohort 2
~T-reg: 3 x 10e5/kg
~T-con: 1 x 10e6/kg
~Cohort 3
~T-reg: 1 x 10e6/kg
~T-con: 3 x 10e6/kg
~Cohort 4
~T-reg: 3 x 10e6/kg
~T-con: 1 x 10e7/kg"
16244435|NCT01050764|Drug|Conventional T-cells|These are conventional (unselected) donor T-cells. Cell dosage of the infusion will be based on the CD3+ cell content and infused on day +16.
16244436|NCT01050764|Drug|Melphalan|Anti-cancer chemotherapy drug administered IV at 140 mg/m² on Day -8 prior to HSCT (a component of the conditioning regiment prior to infusion of cells)
16244437|NCT01050764|Drug|Thiotepa|Anti-cancer chemotherapy drug administered IV at 10 mg/kg on Day -7 prior to HSCT (a component of the conditioning regiment prior to infusion of cells)
16244438|NCT01050764|Device|Fludarabine|Anti-cancer chemotherapy drug administered IV at 160mg/m² on Days -6; -5; -4; and -3 prior to HSCT (a component of the conditioning regiment prior to infusion of cells
16244439|NCT01050764|Drug|Anti-thymocyte globulin, rabbit|Rabbit-derived antibodies against human T-cells used as transplant rejection prophylaxis. Administered at 6 mg/kg IV on Days -6; -5; -4; and -3 prior to HSCT
16244440|NCT01050764|Drug|CliniMACS CD34 Reagent System|An in vitro medical device system that uses antibodies conjugated to magnetic beads to select and enrich for CD34+ blood stem cells from the allogeneic donor apheresis product prior to HSCT, while removing other cells that can cause GvHD. CD34+ cell dosage will be based on the participant's body weight.
16244441|NCT01050751|Drug|Lersivirine|Oral Lersivirine 750 mg (1 x 750 mg) single dose
16244442|NCT01050751|Drug|Lersivirine|Oral Lersivirine 750 mg (3 x 250 mg) single dose
16244443|NCT01050738|Procedure|Position of catheter|Position of catheter for administration of local anestesia.
16244444|NCT01050712|Drug|Inhaled Carbon Monoxide|Concentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection
16244445|NCT01050712|Drug|Synthetic Air|Patients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection
16244446|NCT01050699|Drug|Dexmedetomidine|Intravenous continuous infusion will be initiated with a (optional) loading dose of 1 mcg/Kg over 10 minutes followed by a maintenance infusion of 0.5 mcg/kg/hour for 24 hours.
16244447|NCT01050699|Drug|Midazolam and Fentanyl|"Midazolam (Versed): Loading dose 2-4 mg IV bolus followed by continuous infusion at 1-7 mg/hour.
~Open label aliquots for pain (Midazolam 1- 4 mg IV bolus.)
~Fentanyl: Loading dose 50-200 mcg IV bolus; Continuous infusion rate 50-300 mcg/hour. Open label aliquots for pain (Fentanyl 50 - 200 mcg IV bolus.)"
16244448|NCT01050686|Procedure|insertion of subcutaneous wound drain|after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted
16244449|NCT01050686|Procedure|no insertion of subcutaneous wound drain|closure of abdominal wall and skin without insertion of subcutaneous wound drain
16244450|NCT01050673|Device|VERSAJET|Hydro-surgery debridement
16244451|NCT01050673|Procedure|Scalpel or blade|Conventional Surgical Debridement
16244452|NCT01050660|Other|Intravenous fat emulsion|An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
16244453|NCT01050660|Other|Restriction of intravenous fat emulsion to 1 gm/kg/d|Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
16244454|NCT01050647|Drug|17-Hydroxyprogesterone Caproate|Weekly injections of 17-hydroxyprogesterone caproate.
16244455|NCT01050647|Other|Caster Oil injections|Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
16244456|NCT01050634|Drug|Aromasin (exemestane)|25mg oral tablet, daily, for >1yr
16244457|NCT01050621|Dietary Supplement|vitamin C (ascorbic acid)|ascorbic acid 1.5 g/kg body weight infused over 90 to 120 minutes two or three times weekly concurrent with standard cytotoxic chemotherapy individually selected for each patient by the treating oncologist on the basis of best current clinical practice
16244458|NCT01050608|Device|Body worn alcohol gel dispenser|Records hand hygiene events of provider and tabulates on the group level.
16244459|NCT01050608|Drug|62% ethanol based hand cleanser|"CDC based guidelines with regard to utilization in the health care environment the nest"
16244460|NCT01050608|Behavioral|Educational component with regard to teaching CDC guidelines|12 minute education prior to deploying device for all providers.
16244461|NCT01050608|Behavioral|Provider and group feedback|Provide feedback with regard to expected hand hygiene goals to providers and reported anonymous group results based on recorded information.
16244462|NCT01050595|Drug|Methylnaltrexone Bromide|The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance <30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.
16244463|NCT01050595|Drug|Placebo-Normal Saline|Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started.
16244464|NCT01050582|Drug|Risperidone|As per local prescribing practices
16244465|NCT01050582|Drug|Other atypical antipsychotic drugs|As per local prescribing practices
16244466|NCT01050569|Drug|Nicotine Patch|21 mg
16244467|NCT01050569|Other|VLNC Cigarette|Cigarette where the tobacco contains <0.1 mg of nicotine yield.
16244468|NCT01050569|Other|VLNC Cigarette Plus Nicotine Patch|21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
16244469|NCT01050556|Other|Placebo|daily, 24 weeks
16244470|NCT01050556|Dietary Supplement|folic acid|400 ug/d for 12 or 24 weeks
16244471|NCT01050556|Dietary Supplement|folic acid|800 µg/d for 12 or 24 weeks
16244472|NCT01050556|Dietary Supplement|creatine|3 mg/d for 12 weeks
16244473|NCT01050556|Dietary Supplement|creatine + folic acid|3 mg creatine/d + 400 µg folic acid/d for 12 weeks
16244474|NCT01050543|Drug|sugammadex|sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion
16244475|NCT01050543|Drug|neostigmine|neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion
16244476|NCT01050530|Drug|OPC-41061|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
16244477|NCT01050530|Drug|Placebo|Once-daily oral administration of placebo after breakfast for 7 days
16244478|NCT01050517|Drug|albendazole + ivermectin + praziquantel|albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)
16244479|NCT01050517|Drug|albendazole + ivermectin + (1 week later) praziquantel|albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)
16244480|NCT01050504|Other|Cytology Specimen Collection Procedure|Correlative studies
16244481|NCT01050504|Other|Laboratory Biomarker Analysis|Correlative studies
16244482|NCT01050491|Drug|sitaxentan|100 mg once a day during one year. Bronchial fibroscopy
16244483|NCT01050491|Drug|placebo|placebo, one per day, during one year. Bronchial fibroscopy
16244484|NCT01050478|Drug|Paliperidone ER|paliperidone ER at 2 dosage levels (6 and 9 mg/day)
16244485|NCT01050478|Drug|Benzodiazepine|Participants may receive the benzodiazepine lorazepam [0-7.5 milligram (mg) per day] as needed for sedation or rescue medication at the investigator's discretion.
16244486|NCT01050465|Other|health information prescription|Patients randomized to the email arm will receive a health information prescription via email on a health care topic following their clinic visit. Patients randomized to the paper arm will receive a health information prescription on paper on a health care topic following their clinic visit.
16244487|NCT01050452|Drug|albendazole|albendazole (400 mg on dose)
16244488|NCT01050452|Drug|mebendazole|mebendazole (500 mg one dose)
16244489|NCT01050452|Drug|ivermectin|ivermectin (200 microgram/kg body weight)
16244490|NCT01050452|Drug|albendazole + ivermectin|albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
16244491|NCT01050452|Drug|mebendazole + ivermectin|mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)
16244492|NCT01050439|Procedure|UDAlloSCT|unrelated matched donor allogeneic stem cell transplantation (UDAlloSCT)
16244493|NCT01050439|Other|Therapy|Full Intensity Therapy (myeloablative) (TBI + Thiotepa + Cyc) OR Reduced Intensity Therapy (Fludarabine, Busulfan, and Alemutuzumab (FBA))
16244494|NCT01050426|Other|UFT, Leucovorin|UFT 300mg/m2/day in 3 equal doses and Leucovorin 90mg/day in 3 divided doses per day given daily on the days of radiotherapy only (30 days in total)
16244495|NCT01050426|Other|UFT/ Leucovorin + Cetuximab + Radiotherapy|UFT 300mg/m2 + LV 90mg/day on days of RT only (30 days in total), Cetuximab 400mg/m2 week 1, thereafter 250mg/m2 weeks 2-6
16244496|NCT01050400|Genetic|Cytochrome P450 2D6 (CYP2D6) genetic screening.|Genetic screening for cytochrome P450 2D6 (CYP2D6) polymorphism will be conducted on genetic information obtained from non-invasive salivary samples.
16244497|NCT01050387|Dietary Supplement|Vitamin D|Vitamin D (either 400 IU vs 1000 IU) given orally each day
16244498|NCT01050374|Drug|albendazole + praziquantel|albendazole (400 mg one dose) + praziquantel (40 mg/kg body weight)
16244499|NCT01050374|Drug|mebendazole + praziquantel|mebendazole (500 mg one dose) + praziquantel (40 mg/kg body weight)
16244500|NCT01050361|Procedure|Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)|Duration lasts the entire operation.
16244501|NCT01050348|Drug|Atorvastatin calcium|Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.
16244502|NCT01050348|Drug|Inactive Placebo|Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
16244503|NCT01050335|Behavioral|Simuvision Simulator|Participants will perform common surgical procedures on the simulator
16244504|NCT01050322|Drug|Lapatinib Vinorelbine|The starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
16244505|NCT01050322|Drug|Lapatinib Capecitabine|The starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
16244506|NCT01050322|Drug|Gemcitabine Lapatinib|The starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
16244507|NCT01050309|Drug|hexaminolevulinate (HAL)|Intravenous dose of HAL 0.4 mg/kg including 100 nCi (3.7 kBq) 14C infused over a one hour period. A vaginal dose HAL 150 mg including 13,9 kBq of 14C HAL will be administered for 7 hours. Following a colon cleaning, 100mg HAL enema including 14,8 kBq of 14C will be instilled for 30 minutes in colon
16244508|NCT01050283|Procedure|Comparator: [18F]-FDG PET/CT and Volumetric CT|Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.
16244509|NCT01050270|Drug|Ondansetron|4mgs iv bolus
16244510|NCT01050270|Drug|acetylcysteine|100 mg/kg over 2 hours then 200mg/kg over 10 hours, followed by glucose 5% for 8 hours
16244511|NCT01050270|Drug|acetylcysteine|150 mg/kg over 15 mins 50 mg/kg over 4 hours 100 mg/kg over 16 hours
16244512|NCT01050257|Drug|Oseltamivir IV|Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
16244513|NCT01050257|Drug|Oseltamivir Oral|Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
16244514|NCT01050244|Dietary Supplement|Whole soybean soymilk powder|
16244515|NCT01050244|Dietary Supplement|Whole milk powder|
16244516|NCT01050231|Device|Functional/ Multi-joints activities|Subjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
16244517|NCT01050231|Device|Individual Joint Training|Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time.
16244518|NCT01050218|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|
16244519|NCT01050205|Behavioral|Current Intervention|"Participants assigned to Current Intervention will receive the intervention described below immediately after randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity.
~GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings."
16244520|NCT01050205|Behavioral|Delayed Intervention|"Participants assigned to Delayed Intervention receive the same intervention as Current Intervention Group, 6 months from randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity.
~GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings."
16244521|NCT01050179|Other|carbon dioxide|sinusoidal carbon dioxide delivery
16244522|NCT01050166|Other|Transplantation of labeled islets|
16244523|NCT01050153|Drug|Dalteparin sodium|Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
16244524|NCT01050153|Drug|Dalteparin sodium/aspirin|Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po.
16244525|NCT01050140|Dietary Supplement|high sugar diet|25% of dietary energy from fructose or glucose
16244526|NCT01050127|Drug|ABT-436|See Arm Description for details.
16244527|NCT01050127|Drug|Placebo|See Arm Description for details.
16244528|NCT01050114|Drug|onaBoNT-A|"onaBoNT-A will be the active formulation. Each vial of onaBoNT-A Purified Neurotoxin Complex, Formulation No. 9060X, contains: 100 units (U) of Clostridium botulinum toxin type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. One U corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. A 0.9% sterile saline (without preservative) for injection will be used as diluent for onaBoNT-A.
~Each treatment session will be administered as 20 injections each of 1 mL (10U/ml), evenly distributed into the bladder."
16244529|NCT01050114|Drug|Oxybutynin ER|Oxybutynin ER in a 10 mg capsule will be taken twice a day for the course of the study.
16244530|NCT01050101|Dietary Supplement|No fiber|"The High GI low fiber meal consists of 0 grams fiber with total kcal of 573 with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein.
~Test meal consists of breakfast meals containing muffins and yogurt beverage/shake."
16244531|NCT01050101|Dietary Supplement|Low GI high fiber viscous meal|"Test meal consists of 12 grams of fiber (9 grams soluble and 3 grams insoluble). The ratio is 80:20 ratio of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose).
~Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake."
16244532|NCT01050101|Dietary Supplement|Low GI high fiber non-viscous|"Test meal consists of 11 grams of fiber (3 grams soluble and 8 grams insoluble). The ratio is 20:80 of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose).
~Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake."
16244533|NCT01050088|Dietary Supplement|sucrose solution|5cc 5% sucrose solution P/O
16244534|NCT01050088|Dietary Supplement|Saline|5cc saline p/o
16244535|NCT01050075|Other|acupuncture therapy|acupuncture therapy
16244536|NCT01050075|Other|questionnaire administration|Ancillary study
16244537|NCT01050075|Other|management of therapy complications|To be determined by the treating physician
16244540|NCT01050062|Drug|Hydrochlorothiazide 12.5mg|Combination tablet
16244541|NCT01050036|Procedure|autologous hematopoietic cell transplantation|"Autologous peripheral blood stem cell (PBSCs) harvesting
~After the second cycle of high-dose ara-C(HDAC) consolidation chemotherapy
~Mobilization: recombinant human G-CSF(Filgrastim) 5mcg/kg s.c. daily starting on 10 days after start of the second cycle of HDAC chemotherapy
~Harvest procedure: peripheral blood mononuclear cells will be collected. Target CD34+ cell dose is over 5x10E6/kg.
~Conditioning regimen for autologous HCT
~Busulfan 3.2 mg/kg/day i.v. daily on days -7 to -5 (for 3 days)
~Etoposide 400mg/m2/day i.v. daily on days -3 to -2 (for 2 days)
~Autologous cell infusion and waiting for engraftment"
16244542|NCT01050023|Device|Provant Device (Wound Therapy System)|Twice daily application of the active Provant device to the wound for twelve (12) weeks.
16244543|NCT01050023|Device|Provant Device - Inactive|Twice daily application of the inactive Provant device to the wound for twelve (12) weeks.
16244544|NCT01050010|Other|MRI|dedicated extremity MRI
16244545|NCT01049984|Drug|Rasagiline|1mg tablet daily for 18 weeks
16244546|NCT01049984|Drug|Placebo|one tablet daily for 18 weeks
16244547|NCT01049971|Device|wound protector|after minilaparotomy, the wound protector is applied
16244548|NCT01049971|Device|no wound protector|use of woven drape instead of wound protector
16244549|NCT01049945|Drug|bendamustine hydrochloride|Given IV
16244550|NCT01049945|Drug|lenalidomide|Given orally
16244551|NCT01049945|Drug|dexamethasone|Given orally or IV
16244552|NCT01049932|Drug|TMC278LA|TMC278LA 600mg injected intramuscularly (i/m)
16244553|NCT01049919|Device|Bone marrow concentration device|Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
16244554|NCT01049919|Procedure|Placebo procedure (sham)|Sham bone marrow aspiration, sham delivery to affected limb
16244555|NCT01049906|Procedure|Placement of nerve block catheter|Placement of nerve block catheter with nerve stimulator and ultrasound
16244556|NCT01049906|Procedure|Placement of nerve block catheter|Placement of nerve block catheter with ultrasound only
16244557|NCT01049893|Drug|Compound AC220|Precomplexed powder in bottle formulation supplied as 135 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.
16244558|NCT01049880|Drug|Gemcitabine with escalating ascorbic acid|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion
~Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL."
16244559|NCT01049867|Procedure|Intracoronary Infusion of CD133+ Cells|Single intracoronary infusion of a suspension consisting of 30 ml saline solution containing at least 1 million CD133+ endothelial precursor cells.
16244560|NCT01049854|Drug|Full Intensity with TBI|Patients will start their pre-conditioning regimen on Day -8. Fractionated TBI will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5, -4, Cyclophosphamide on Days -3, -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.
16244561|NCT01049854|Drug|Full Intensity|Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with stem cell infusion on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.
16244562|NCT01049854|Drug|Reduced Intensity|Patients will start their GVHD prophylaxis with Tacrolimus on Day -9. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.
16244563|NCT01049854|Drug|Reduced Intensity (Fanconi)|Patients will start their pre-conditioning regimen on Day -6. Patients will receive TBI as a single fraction on Day -6. Patients will receive fludarabine and cyclophosphamide on Days - 5, -4, -3, and -2 and antithymocyte globulin (horse) on Days -5, -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.
16244564|NCT01049841|Drug|perifosine + temsirolimus|The patient will take oral tablets of perifosine at a dose and frequency to be determined their height, weight and time when they enter the study as those entering early will be treated with lower dose levels (dosing frequency will vary from once a week to daily). The patient will receive an intravenous injection of temsirolimus once a week at a dose to be determined by their height, weight and time when they enter the study as those entering early will be treated with lower doses. In addition they will be asked to keep a medicine diary.
16244565|NCT01049828|Other|No intervention|No treatment for tinnitus will occur in this study.
16244566|NCT01049815|Drug|sevelamer hydrochloride|800-3200 mg with each meal
16244567|NCT01049815|Drug|Calcium Carbonate|600 mg with each meal, up to 1800 mg a day
16244568|NCT01049802|Device|Repetititve transcranial magnetic stimulation|1 Hz rTMS to contralesional hemisphere in patients with stroke
16244569|NCT01049789|Behavioral|COMB - Combination Cognitive Behavioral Therapy and Medication Management|"Phase I: 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals. Study coordinators and site clinicians will document depression symptoms and treatment regimens for all participants for 24 weeks. Site staff and participants at COMB sites will participate in an exit interview and findings will be used to revise CBT and MM intervention manuals at the end of Phase I.
~Phase II: similar procedures as Phase I; COMB sites will implement the revised CBT and MM manuals. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. All Phase II participants will have 2 follow-up visits at weeks 36 and 48."
16244602|NCT01049542|Drug|Astressin 2B|After an initial saline washout, increasing doses of Astressin 2B (at 0.032, 0.32, 3.2, 32, 320 and 3200 pmol/min) will be infused, for 10 minutes at each dose,intra arterially using forearm venous occlusion plethysmography. Forearm blood flow will be measured with each incremental dose of Astressin 2B.
16244730|NCT01048736|Behavioral|Exercise + Diet|Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss)
16244570|NCT01049789|Behavioral|TAU - Treatment as Usual|"Phase I: Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two.
~Phase II: Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48."
16244571|NCT01049776|Drug|Pazopanib (GW786034)|Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
16244572|NCT01049763|Drug|oseltamivir|oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose
16244573|NCT01049750|Other|type 2 diabetic patients|males; type 2 diabetic patients
16244574|NCT01049724|Other|Tear collection|Tear collection
16244575|NCT01049711|Drug|erythropoietin|
16244576|NCT01049698|Behavioral|Resistance Training|3 d/wk resistance training
16244577|NCT01049698|Behavioral|Resistance Training + Diet|3 d/w resistance training plus 600 kcal/d deficit
16244578|NCT01049685|Drug|First-line Antiretroviral Therapy|"Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
~Efavirenz: 01 capsules day, plus NRTI background"
16244579|NCT01049672|Drug|Alfentanil|Titrated to a maximum dose of 50mg in 24 hours subcutaneously
16244580|NCT01049672|Drug|Diamorphine|Titrated to a maximum dose of 500mg in 24 hours given subcutaneously
16244581|NCT01049659|Behavioral|Neuropsychological test|Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old
16244582|NCT01049646|Drug|Angiotensin II|Infusion of a subpressor dose of angiotensin II will be give, this will be 0.5microG/min/kg. Thereafter thre ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
16244583|NCT01049646|Drug|Saline|Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
16244584|NCT01049633|Biological|Allogeneic Pancreatic Islet Cells|200mL sterile suspension of allogeneic human pancreatic islets
16244585|NCT01049633|Drug|Sirolimus|Dosed to maintain whole blood 24-hr trough levels 10-15ng/mL for first 3 months and 8-12ng/mL thereafter daily. Sirolimus is used to prevent transplant rejection.
16244586|NCT01049633|Biological|Basiliximab|20mg intravenously (IV) 2hrs prior to islet infusion and on Day 4 post-transplant. Basiliximab is used to prevent transplant rejection
16244587|NCT01049633|Drug|Tacrolimus|Initial dose of 0.015mg/kg p.o. daily on Day 1 post transplant, and adjusted to maintain 12-hr trough levels 3-6ng/mL. Tacrolimus lowers the risk of organ rejection
16244588|NCT01049633|Drug|Antibacterial, Antifungal, and Antiviral Prophylaxis|Broad spectrum antimicrobial prophylaxis administered preoperatively
16244589|NCT01049633|Drug|Trimethoprim/sulfamethoxazole|80mg/400mg by mouth once a day starting on Day 1 for duration of the study follow-up. This medication is used to prevent bacterial infections.
16244590|NCT01049633|Drug|Clotrimazole|1 troche by mouth 4 times daily starting two days prior to transplant until 3 months after the transplant. This medication is used to prevent fungal infections.
16244591|NCT01049633|Drug|Valganciclovir|450mg dose by mouth once a day starting two days pre-transplant and increasing to 900 mg once a day by Day 12 and continuing for 14 weeks post-transplant. This medication is used to prevent cytomegalovirus infections.
16244592|NCT01049633|Drug|Heparin|70U/kg body weight of recipient given with islet infusion, followed by 3U/kg/hr for the next 4hrs. From 5th through 48th hr post-transplant heparin will be titrated to achieve and maintain a Partial Thromboplastin Time (PTT) of 50-60 seconds. This medication is used to prevent the formation of blood clots.
16244593|NCT01049633|Drug|Enoxaparin|30mg subcutaneously twice a day from 48 hrs post-transplant through Day 7 post-transplant. This medication is used to prevent the formation of blood clots.
16244594|NCT01049633|Drug|Pentoxifylline|400mg slow release tablet by mouth three times a day beginning 2 days prior to transplant and continue for 7 days post transplant. This medication improves blood flow.
16244595|NCT01049633|Drug|Aspirin|81mg enteric coated aspirin by mouth every night, starting 24hrs post-transplant. This medication prevents blood clots.
16244596|NCT01049620|Drug|RAD001, Capecitabine, Oxaliplatin|"Dose level -1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 5mg po qd D1-21
~Dose level 1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
~Dose level 2 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
~Dose level 3 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
~Dose level 3A : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21
~Dose level 3B : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 10mg po qd D1-21
~Dose level 4 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
~Dose level 5 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21"
16244597|NCT01049607|Procedure|Clamp-Crush technique|The transectional line is marked and the liver capsule is cauterized. The liver parenchyma is then crushed stepwise using a regular Pèan clamp. Vessels and bile ducts are ligated or clipped. Vessels of less than 2mm diameter are coagulated with the irrigated bipolar forceps.
16244598|NCT01049607|Procedure|Stapler hepatectomy|The transectional line is marked and the liver capsule is cauterized. For subsequent transection of the hepatic parenchyma, the liver tissue is fractured with a vascular clamp in a stepwise fashion and subsequently divided with endo GIA vascular staplers.
16244599|NCT01049581|Procedure|aquatic therapy|two hours per week, one hour per time, total 12 weeks
16244600|NCT01049568|Behavioral|Cell Phone Intervention|"Cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator.
~Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization."
16244601|NCT01049555|Other|Actigraphy and video recording signal|Actigraphy and video recording signal during 1 hour
16244689|NCT01049035|Biological|Rotavirus Vaccine|oral
16244690|NCT01049035|Biological|Hepatitis B Vaccine|0.5 mL, IM injection
16244603|NCT01049529|Dietary Supplement|Docosahexaenoic acid|DHA have oil form. Each neonate is receiving 75 mg/kg/day of DHA in 188 uL/kg/day in two doses per day, since two days before surgery and over six days following cardiovascular surgery
16244604|NCT01049529|Dietary Supplement|Placebo|Placebo have oil form. Each neonate is receiving 188uL/kg/day of sunflower oil as placebo in two doses per day, since two days before surgery and over six days following cardiovascular surgery
16244605|NCT01049516|Behavioral|Prolonged Exposure Therapy - Massed|10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.
16244606|NCT01049516|Behavioral|Prolonged Exposure Therapy - Spaced|10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions 1-3 occur in the first two weeks, Sessions 4-5 occur in Weeks 3-4, and Sessions 6-10 occur in Weeks 5-10.
16244607|NCT01049516|Behavioral|Minimal Contact Control|Participants receive minimal contact for 4 weeks after randomization and thereafter are offered PE-Spaced or PE-Massed, according to their preference. Participants receive 10-15 minute phone calls once per week by the study therapist or independent evaluator in order to monitor their status and to provide support as needed.
16244608|NCT01049516|Behavioral|Present-Centered Therapy|10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants
16244609|NCT01049503|Other|Low fluoride and conventional dentifrices with different pH|Comparison of different dentifrice fluoride concentrations and pH on caries control
16244610|NCT01049490|Biological|S-OIV H1N1 vaccine|Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional
16244611|NCT01049477|Other|Music group|The patients randomized to the music group of the study will listen to music 30 minutes in the holding room prior to their c/s. They will then listen to music after their c/s for 30 minutes. They will complete the STAI before and after their c/s.
16244612|NCT01049477|Other|Non music group|Patients randomized to the non music group will complete the STAI before and after their c/s, but not listen to music.
16244613|NCT01049464|Drug|Placebo|5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.
16244614|NCT01049464|Drug|Magnesium sulphate|Magnesium sulphate 2g diluted with 5%D/W into 20 ml solution, intravenous infusion in 10 min then Magnesium sulphate 6g diluted with 5%D/W into 100 ml solution, intravenous infusion in 6 hours.
16244615|NCT01049451|Drug|ACTH|Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.
16244616|NCT01049451|Drug|Methylprednisolone|Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months
16244617|NCT01049438|Drug|nasal mupirocin|twice daily for 10 days
16244618|NCT01049438|Drug|topical 3% hexachlorophene body wash|daily for 10 days
16244619|NCT01049438|Drug|oral anti-MRSA antibiotic|The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient
16244620|NCT01049425|Drug|Epirubicin|4 cycles, intravenous use, day 1 every three weeks
16244621|NCT01049425|Drug|Cyclophosphamide|4 cycles, intravenous infusion, day 1 every three weeks
16244622|NCT01049425|Drug|Docetaxel|4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy
16244623|NCT01049425|Drug|Cyclophosphamide|6 cycles, intravenous infusion, day 1 every 3 weeks
16244624|NCT01049425|Drug|Docetaxel|6 cycles, intravenous infusion, day one every three weeks
16244625|NCT01049412|Drug|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
16244626|NCT01049412|Drug|Insulin glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
16244627|NCT01049399|Drug|tideglusib|800 mg of tideglusib as a powder for oral suspension once daily in fasting conditions for 52 weeks
16244628|NCT01049399|Drug|tideglusib|600 mg of tideglusib as a powder for oral suspension, administered once daily in fasting conditions for 52 weeks
16244629|NCT01049399|Drug|placebo|powder for oral suspension administered once daily in fasting conditions for 52 weeks
16244630|NCT01049386|Other|No intervention|In obese and lean subjects the intestinal absorption will be examined under normal conditions with sugar drink, and when disturbed by a high-fat breakfast.
16244631|NCT01049386|Procedure|Sugar absorption test|On one of the test days the subjects will consume a high-fat breakfast.
16244632|NCT01049373|Drug|HDC|(Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks.
16244633|NCT01049373|Drug|Placebo solution|10 drops, t.i.d, 15 weeks
16244634|NCT01049360|Drug|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
16244635|NCT01049360|Drug|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
16244636|NCT01049360|Drug|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
16244637|NCT01049360|Drug|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
16244638|NCT01049360|Drug|Placebo|Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.
16244639|NCT01049347|Drug|amitriptyline|150 mg oral, daily, single evening dose, 35 days
16244640|NCT01049347|Drug|paroxetine|40 mg oral, single dose, morning, 35 days
16244641|NCT01049334|Drug|Placebo|Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.
16245662|NCT01041781|Drug|celecoxib|Given orally
16244642|NCT01049334|Drug|Flurbiprofen|Participants were instructed to suck one flurbiprofen 8.75 mg lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.
16244643|NCT01049321|Dietary Supplement|DASH diet|
16244644|NCT01049321|Dietary Supplement|a usual diabetic diet|
16244645|NCT01049295|Dietary Supplement|oil fish|Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
16244646|NCT01049295|Other|corn oil pearls|corn oil pearls 3 times a day
16244647|NCT01049282|Biological|Antigen (Ag85B-ESAT-6)|Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
16244648|NCT01049282|Biological|Antigen (Ag85B-ESAT-6) with adjuvant (IC31)|Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
16244649|NCT01049256|Other|carbon dioxide|sinusoidal carbon dioxide administration
16244650|NCT01049243|Drug|Fluocinonide Cream 0.1%|0.1% Cream, One Application, Twice Daily, 14 Days
16244651|NCT01049230|Radiation|Proton Beam radiation|Once a day, 5 days a week (Monday-Friday), for 4-8 weeks
16244652|NCT01049217|Drug|pregabalin|Pregabalin 75 mg-300mg twice daily during the course of the study.
16244653|NCT01049217|Drug|placebo|Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
16244654|NCT01049204|Drug|Maraviroc|Maraviroc 150 mg twice daily for 24 weeks
16244655|NCT01049204|Drug|placebo|Placebo twice daily for 24 weeks
16244656|NCT01049178|Drug|Oral Silymarin|Dose Level 1: 1 capsules (1 cap at 140mg/cap) given three times per day for a total daily dose of 420 mg 28-days post Dose Level 1 Dose Level 2: 3 capsules (3 caps at 140mg/cap = 420 mg) given three times per day for a total daily dose of 1260 mg Day 56 (28-days post Dose Level 2) Dose Level 3: 5 capsules (5 caps at 140mg/cap = 700 mg) given three times per day for a total daily dose of 2100 mg Day 84 (28-days post Dose Level 3) We will evaluate change from baseline at each dose to determine the minimum effective dose.
16244657|NCT01049178|Drug|Oral Silymarin, maintenance dose|The maintenance Silymarin dose will be selected based on the dose escalation study and will be dosed PO three times daily as recommended. Silymarin will be provided as a capsule S. marianum (70-80% silymarin), along with an identical appearance placebo capsule created by our investigational pharmacyAt each visit a questionnaire regarding daily symptoms and disease control, the asthma control test (ACT) will be completed, eNO measured, urine collected, spirometry (lung function) measured, venipuncture performed for blood collection (20 mL), as well as assessment of acceptability, toxicity, and masking.
16244658|NCT01049178|Drug|Placebo|
16244659|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 5 mg, Single dose, 1 day
16244660|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 20 mg, Single dose, 1 day
16244661|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 60 mg, Single dose, 1 day
16244662|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 150 mg, Single dose, 1 day
16244663|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 300 mg, Single dose, 1 day
16244664|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 600 mg, Single Dose, 1 day
16244665|NCT01049165|Drug|[14C] BMS-813160|Oral Solution, Oral, 150 mg, Single Dose, 1 day
16244666|NCT01049165|Drug|Placebo|Oral Solution, Oral, 0 mg, Single Dose, 1 day
16244667|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 1200 mg, Single dose, 1 day
16244668|NCT01049165|Drug|BMS-813160|Oral Solution, Oral, 2000 mg, Single Dose, 1 day
16244669|NCT01049152|Device|Continuous Glucose Monitoring (CGM)|CGM allocated one time for 3 days
16244670|NCT01049139|Behavioral|1-sided messages|Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).
16244671|NCT01049139|Behavioral|2-sided messages|Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument).
16244672|NCT01049126|Other|ChemoFx|Chemoresponse Marker Assay
16244673|NCT01049113|Drug|ON 013105|2-hour intravenous infusion once a week. Starting dose is 17 mg. Maximum dose will be 1525 mg.
16244674|NCT01049100|Procedure|lymphadenectomy|paraaortal and pelvic lymphadenectomy laparoscopic or open
16244675|NCT01049100|Other|Standard Staging|clinical Staging (FIGO) (examination in narcosis, biopsy, cystoscopy, rectoscopy) X-Ray Radiograph of Thorax, Ultrasound of abdomen, CT abdomen / pelvis positive, suspicious lymphnodes--> CT controlled biopsy
16244676|NCT01049087|Radiation|Plasma volume determination (99mTc-albumin)|The test is performed using 5MBq technetium-labeled albumin (99mTc-albumin-Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
16244677|NCT01049087|Radiation|Plasma volume determination (125I-albumin)|The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.
16244678|NCT01049074|Other|Acupuncture Treatment|Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.
16244679|NCT01049074|Other|Sham acupuncture|Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.
16244680|NCT01049061|Drug|MORAb-003|MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose
16244681|NCT01049048|Dietary Supplement|Vitamin D3|2500 IU Vitamin D3
16244682|NCT01049048|Dietary Supplement|Placebo|No (0 IU) vitamin D3 added to cookie.
16244683|NCT01049035|Biological|Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate|0.5 milliliter (mL), Intramuscular (IM) injection
16244684|NCT01049035|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)|0.5 mL, IM injection
16244685|NCT01049035|Biological|M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live|0.5 mL, Subcutaneous (SC) injection
16244686|NCT01049035|Biological|Varicella Virus Vaccine Live|0.5 mL, SC injection
16244687|NCT01049035|Biological|Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)|0.5 mL, IM injection
16244688|NCT01049035|Biological|Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)|0.5 mL, IM injection
16244691|NCT01049022|Drug|Moxifloxacin (Avelox, BAY12-8039)|Single intravenous (IV) infusion of moxifloxacin administered over 60 minutes, at an initial dosage of 5 milligram per kilogram per body weight (mg/kg/BW) with dose escalation to 6 mg/kg in subjects of age 6 years (yrs) to less than or equal to (<=) 14 years.
16244692|NCT01049022|Drug|Moxifloxacin (Avelox, BAY12-8039)|Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 7 mg/kg/BW with dose escalation to 8 mg/kg in subjects of age 2 years to less than (<) 6 years; dose escalation was based on evaluations of the pharmacokinetic (PK) and safety data from the subjects in a preceding cohort.
16244693|NCT01049022|Drug|Moxifloxacin (Avelox, BAY12-8039)|Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 9 mg/kg/BW with dose escalation to 10 mg/kg in subjects of age 3 months to < 2 years; dose escalation was based on evaluations of the PK and safety data from the subjects in a preceding cohort.
16244694|NCT01049009|Drug|Nebivolol|"Subjects will be randomized to either nebivolol or metoprolol xl, and remain on the study drug for 10 weeks. They will then cross over to take 10 weeks of the comparator drug."
16244695|NCT01049009|Drug|Metoprolol XL|"Subjects will be randomized to either nebivolol or metoprolol xl, and remain on the study drug for 10 weeks. They will then cross over to take 10 weeks of the comparator drug."
16244696|NCT01048983|Drug|Armodafinil|Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
16244697|NCT01048983|Drug|Bupropion|Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
16244698|NCT01048983|Drug|Minocycline|Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
16244699|NCT01048983|Drug|Curcumin|Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.
16244700|NCT01048983|Behavioral|Telephone Questionnaire|Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
16244701|NCT01048970|Other|Nutritional Assessment|Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
16244702|NCT01048970|Dietary Supplement|EPA-DHA arm|Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy
16244703|NCT01048957|Behavioral|Real Time Feedback Training|
16244704|NCT01048944|Drug|Bupropion SR|150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
16244705|NCT01048944|Drug|Nicotine Patch|Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
16244706|NCT01048944|Drug|Placebo Patch and Placebo Pill|150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days. The placebo patches were given beginning 1st day cessation: 21 mg size (but actually placebo)/24 days, 14 mg size (actually placebo)/ 14 mg size (actually placebo) 14 days/, 7 mg size (actually placebo)/7 days
16244707|NCT01048931|Procedure|single-port LAVH|single-port LAVH
16244708|NCT01048905|Drug|L-Glutamine|Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
16244709|NCT01048892|Biological|Seneca Valley virus-001|
16244710|NCT01048892|Drug|cyclophosphamide|
16244711|NCT01048892|Other|laboratory biomarker analysis|
16244712|NCT01048892|Other|pharmacological study|
16244713|NCT01048879|Procedure|pharmacokinetic blood sampling|blood samples collected to assess oseltamivir concentrations
16244714|NCT01048879|Procedure|pharmacokinetic blood and dialysate sampling|blood and dialysate samples collected and assayed for oseltamivir concentrations
16244715|NCT01048866|Drug|placebo|Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.
16244716|NCT01048866|Drug|flurbiprofen|Sugar-based, flavoured flurbiprofen 8.75 mg lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.
16244717|NCT01048866|Drug|acetaminophen 650mg|Rescue medication to be taken as needed. Rescue medication was not blinded.
16244718|NCT01048853|Procedure|Conservative Surgery|Removal of the pelvic lymph nodes (pelvic lymphadenectomy)
16244719|NCT01048827|Drug|Busulfan|"1250 uMol*min (AUC to time 6 hrs)^
~1400 uMol*min (AUC to time 6 hrs
~1550 uMol*min (AUC to time 6 hrs)^"
16244720|NCT01048814|Other|ChemoFx|Chemoresponse Marker Assay
16244721|NCT01048801|Device|Rapid diagnostic test|Use of rapid daignostic tests for diagnosis of malaria
16244722|NCT01048801|Other|presumptive malaria treatment|Treatment of malariabased on clinical diagnosis without use of diagnostic test
16244723|NCT01048788|Drug|OPC-41061|OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.
16244724|NCT01048762|Other|physical exercise and dyspnoea counseling|Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.
16244725|NCT01048762|Other|home training|one instruction in home based exercise training
16244726|NCT01048749|Other|aquatic vertical suspension.|Subject is suspended in a warm water deep pool with two pool noodles around the subject and directly under the axilla. Five pound weights are placed on the ankle and the subject maintains this unloaded position for 15 minutes.
16244727|NCT01048749|Other|land-based supine flexion|The subject will lay supine with the legs supported by a foam wedge with hips flexed to 90 degrees and knees flexed to 65 degrees. They will maintain this unloaded position for 15 minutes.
16244728|NCT01048736|Behavioral|Exercise Only|4 d/wk of aerobic exercise
16244729|NCT01048736|Behavioral|Exercise + Diet|Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss).
16244731|NCT01048723|Drug|RAD001|Patients were instructed to take RAD001 in the morning, at the same time each day.
16244733|NCT01048697|Drug|Ethambutol|"All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
16244734|NCT01048684|Drug|Mannitol|Variation of mannitol dose
16244735|NCT01048684|Drug|Mannitol|Variation of mannitol dose
16244736|NCT01048671|Drug|Raltegravir|Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.
16244737|NCT01048671|Drug|ARV (non-raltegravir)|ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.
16244738|NCT01048658|Drug|Sevoflurane|Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
16244739|NCT01048658|Other|No Sevoflurane|Subject only standard of care drug regimens for anesthesia with this procedure.
16244740|NCT01048645|Drug|ATRA|Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
16244741|NCT01048645|Other|PLACEBO|Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
16244742|NCT01048632|Drug|Oxandrolone|2.5 mg oxandrolone tablets.Based upon the patient's body weight, the coordinator, PI or sub-PI will determine the appropriate dose of oxandrolone (0.1 mg/kg/dose twice daily via the buccal mucosa.)
16244743|NCT01048619|Drug|ON 01910.Na|In Part I, the bioavailability and tolerability of ON 01910.Na as single, oral, escalating doses in a fasting state (defined as no less than 30 min before next meal) is studied. Three patients get 70mg dose the 1st week. In the absence of drug-related grade 2 toxicity or higher, doses will escalate in each patient weekly (wk) to 140mg (wk 2), 280mg (wk 3), 560mg (wk 4) and 700mg (wk 5). At end of Part I all patients will be eligible for Part II. Part II proceeds if drug is measured in plasma and DLT not observed at 70mg dose in Part I. The maximum tolerated dose of oral ON 01910.Na administered in a fasting state (defined as no less than 30 min before next meal) twice a day for 14 days will be determined following an adaptive design at doses between 70 and 700mg.
16244744|NCT01048606|Behavioral|Placebo + exercise|"Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)
~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
16244745|NCT01048606|Dietary Supplement|Phytoestrogens without exercise|"Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
16244746|NCT01048606|Other|Phytoestrogens + exercise|"Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.
~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
16244747|NCT01048593|Drug|IBI-10090|Single intraocular injection
16244748|NCT01048580|Drug|Perifosine|Perifosine 50 mg orally once a day (Days 1-21)
16244749|NCT01048580|Drug|Capecitabine|Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)
16244750|NCT01048567|Other|Lactobacillus acidophilus/rhamnosus|2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
16244751|NCT01048567|Other|Placebo|2 capsules three times daily for entire duration of antibiotic therapy.
16244752|NCT01048554|Drug|Temozolomide|Temozolomide 75mg/m2 for six continuous weeks
16244753|NCT01048554|Drug|Bevacizumab|Bevacizumab 10mg/kg every 2 weeks without interruption
16244754|NCT01048541|Device|Test Catheter - SpeediCath Compact Male|Compact catheter for intermittent catheterisation
16244755|NCT01048541|Device|SpeediCath|Catheter for intermittent catheterisation
16244756|NCT01048528|Behavioral|Cognitive Behavioral Stress Management (CBSM)|The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Relaxation techniques include progressive muscle relaxation, guided imagery, autogenics, meditation, and deep breathing. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
16244757|NCT01048515|Drug|Caffeine|Caffeine capsule 6 mg/kg given 1 hour before test
16244758|NCT01048502|Drug|Fenofibrate (Tricor) tablets|One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
16244759|NCT01048502|Drug|Placebo|Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
16244982|NCT01046864|Drug|5-FU|IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity
16244760|NCT01048502|Drug|Lovaza|900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
16244761|NCT01048489|Behavioral|Health education in the high school|"(12- 13 years old): 1.Questionnaire and measuring of carbon monoxide in air. 2.Role Games.3.Build a machine that simulates a cigarette.
~(13-14 years old):1.Questionnaire and measuring of carbon monoxide in air.2. Workshop dealing with current television series broadcast in Spain in which tobacco is constantly present.3.Workshop dedicated to make young people and their families stop smoking.A competition is performed between all the schools in order to reward the bookmark with the best motto asking any close person to stop smoking or thanking them for having quit.
~(14-15 years old):1.Questionnaire and measuring of carbon monoxide in air. 2. Workshop to go into depth about tobacco effects,by searching in the internet, aiming for the creation of an anti-tobacco pressure group in social networks such like Facebook.3.Workshop to create an advertising campaign to encourage non-consumption by mobile messages,use of internet..coinciding with the international day without tobacco."
16244762|NCT01048476|Dietary Supplement|lutein|Dietary Supplement: 20mg Lutein; daily supplementation one year
16244763|NCT01048476|Dietary Supplement|Lutein|Dietary Supplement: 10mg Lutein; daily supplementation one year
16244764|NCT01048476|Dietary Supplement|placebo|Dietary Supplement: placebo; daily supplementation one year
16244765|NCT01048476|Drug|Lutein and zeaxanthin|Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
16244766|NCT01048463|Drug|Nutriall|The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
16244767|NCT01048463|Drug|LDEPA|The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.125g of EPA and 0.125g of olive oil. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
16244768|NCT01048463|Drug|Placebo|The subjects take in 24 pils of gelatin capsule (each contains 0.25g of olive oil, provided by nutritional department of our institute) per day. The treatment lasts for 21d.
16244769|NCT01048463|Drug|HDEPA|The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.25g of EPA. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
16244770|NCT01048463|Drug|Chemotherapy|Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)
16244771|NCT01048450|Radiation|Joint Resection- Keller Procedure|These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
16244772|NCT01048450|Procedure|Joint Fusion|Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
16244773|NCT01048450|Procedure|Hemi-metallic Joint Implant|Those who had a surgical procedure of a hemi-metallic joint implant
16244774|NCT01048437|Behavioral|Transplant education with video|1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
16244775|NCT01048437|Behavioral|Transplant education with speakers|1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor
16244776|NCT01048424|Device|RESPeRATE|"RESPeRATE is a commercially available, walkman-like device manufactured by Intercure, Ltd. that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the FDA for treatment of mild hypertension and has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate."
16244777|NCT01048424|Other|Urinary Incontinence Pamphlet|The urinary incontinence pamphlet will provide information about classification, pathophysiology, and management of urinary incontinence, including management strategies such as timed urination and pelvic muscle exercises.
16244778|NCT01048411|Drug|Naja-comp.|homeopathic remedy
16244779|NCT01048411|Drug|Placebo|s.c. injection of NaCl-solution three times a week
16244780|NCT01048398|Drug|remifentanil|intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
16244781|NCT01048398|Drug|paracetamol|Control group: intravenous paracetamol 1g
16244782|NCT01048385|Dietary Supplement|Coenzyme Q10 concomitant treatment|Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment
16244783|NCT01048385|Dietary Supplement|Placebo|Treated with capsules containing the vehicle (Sesame oil).
16244784|NCT01048359|Behavioral|Brief advice|The American College of Surgeons (ACS) recently mandated standards of care for all level I trauma centers and currently defined standards of care at the collaborating institution requires that assessment and referral are included in treatment as usual. Therefore, our treatment as usual, or BA, consists of an initial interview conducted by study staff, a recommendation to abstain from drug use, provision of educational material supporting that recommendation, referral to hospital or community treatment resources most likely to be beneficial to the patient and information about relevant community health care agencies.
16244785|NCT01048359|Behavioral|Brief Intervention plus Booster|A brief drug use intervention based on motivational interviewing is provided to participants at baseline and a booster session incorporating personalized feedback is provided at one month
16244786|NCT01048359|Behavioral|Brief Intervention|A brief drug use intervention based on motivational interviewing is provided to participants at baseline
16244787|NCT01048346|Behavioral|Individual Placement and Support Model|Psychosocial intervention involving an employment specialist working with participants recruited into the study and assisting with employment.
16244788|NCT01048333|Drug|Formoterol|Formoterol Turbuhaler 9 μg and Placebo Diskus
16244789|NCT01048333|Drug|Salmeterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler
16244790|NCT01048333|Drug|Placebo|Placebo Diskus and Placebo Turbuhaler
16244824|NCT01048099|Drug|Trastuzumab|8 mg/kg IV loading dose, followed by 6 mg /kg IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
16244825|NCT01048099|Drug|Pertuzumab|840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
16244791|NCT01048320|Drug|Gemcitabine|"The starting dose of gemcitabine will be 400 mg/m2 on day 1 of a two-week cycle.
~Gemcitabine is given on day 1 every two weeks according to the dose escalation schedule below:
~Dose level -1 200mg/m2 Dose level 1 400mg/m2 Dose level 2 600mg/m2 Dose level 3 800mg/m2 Dose level 4 1000mg/m2 Dose level 5 1000mg/m2 It is administered as an intravenous infusion, the lyophilized powder being diluted in normal saline, at a fixed dose of 10 mg/m2/minute."
16244792|NCT01048320|Drug|Oxaliplatin|Oxaliplatin is given by intravenous infusion on day 2 every 2 weeks according to the dose escalation schedule below: Dose level -1 - 4 85mg/m2 Dose level 5 100mg/m2 Oxaliplatin should be diluted in 250 to 500 ml of 5% glucose solution to give a concentration not less than 0.2 mg/ml. It must be infused via a central venous line or peripheral vein over 2 hours. In the event of extravasation, administration must be discontinued immediately and the extravasation managed according to local procedures.
16244793|NCT01048320|Drug|Imatinib|"Imatinib is given for 7 days every cycle starting 2 days before the gemcitabine is given, including administration on days 1 and 2 when gemcitabine and oxaliplatin are given, and for 3 days afterwards (i.e. days -2 to +5). It is thus given on a 7 days on and 7 days off intermittent dosing schedule. The dose will be fixed at 400 mg daily in tablet form and taken once daily with food.
~Imatinib should commence either in the morning or lunchtime of day -2 and be taken at the same time daily for seven consecutive days in total."
16244794|NCT01048307|Device|Prontosan wound irrigation solution|"Prontosan® Wound Irrigation Solution (experimental group):
~• Active ingredients (Polihexanide 0.1%, Betaine 0.1%) cleansing the wound bed at dressing change with Prontosan® Wound
~Saline (control group):
~cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
~placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
~fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system)."
16244795|NCT01048294|Device|Original Energy Light,|9000 lux, 30 minutes in the morning
16244796|NCT01048294|Device|Original Energy Light prototype|9000 lux 20 minutes in the morning
16244797|NCT01048294|Device|Original Energy Light prototype|9000 lux 30 minutes in the morning
16244798|NCT01048281|Procedure|Blood draw|
16244799|NCT01048281|Procedure|Tissue tumor biopsy|
16244800|NCT01048268|Drug|glucose-dependent insulinotropic polypeptide|"For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.
~For the following 40 minutes the volunteers will receive 2 pmol/kg body weight"
16244801|NCT01048268|Drug|Placebo|copy GIP infusion rates
16244802|NCT01048255|Drug|VX-765|300mg Oral Tablet, 900mg TID
16244803|NCT01048242|Drug|rozerem|Ramelteon (rozerem) 8mg oral before bedtime
16244804|NCT01048242|Drug|Placebo|placebo
16244805|NCT01048229|Drug|Rasagiline|1 mg rasagiline once daily (plus placebo twice daily)
16244806|NCT01048229|Drug|Pramipexole|pramipexole three times daily (titrated from 0.375 mg/day to 1.5 mg/day)
16244807|NCT01048216|Radiation|radiation therapy|CT based 3D treatment shall be used for all patients. There will be 10 equal fractions delivered over 2 weeks. The prescribed dose and fraction will be individualised according to effective liver volume treated
16244808|NCT01048203|Drug|ABR-215050|1 mg ABR-215050
16244809|NCT01048190|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
16244810|NCT01048190|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
16244811|NCT01048190|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
16244812|NCT01048177|Drug|Bladder instillation with heparin/ lidocaine|9 bladder instillations in 6 weeks
16244813|NCT01048164|Procedure|Massage|Chair Massage
16244814|NCT01048151|Biological|TNFerade™ Biologic|AdGVEGR.TNF.11D
16244815|NCT01048138|Drug|Biperiden Lactate|5mg IV(in the vein)every 6 hours for 10 days
16244816|NCT01048138|Drug|Placebo|5mg IV(in the vein)every 6 hours for 10 days
16244817|NCT01048125|Device|Sympathetic Nerve Activity|Resting Sympathetic Nerve Activity
16244818|NCT01048125|Behavioral|Mental Stress Test (Color Word Test)|"A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure."
16244819|NCT01048125|Drug|The Modified Oxford Technique for Baroreflex Sensitivity|Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride (150 µg). Infusion of nitroprusside will decrease blood pressure approximately 10-15 mmHg below baseline values. Subsequent phenylephrine infusion will increase blood pressure approximately 10-15 mmHg above baseline values. Nitroprusside and phenylephrine have been used extensively to assess baroreflex sensitivity in healthy as well as heart failure populations. Additionally, the dosages being used have been shown to minimize the risk of excessive decreases or increases in blood pressure.
16244820|NCT01048125|Other|Cold Pressor Test|The subject will be asked to place their hand in ice water for 2 minutes. This procedure will be used to cause transient changes in sympathetic nerve activity, heart rate and blood pressure.
16244821|NCT01048125|Device|Echocardiographic evaluation|Transthoracic echocardiography with 2D, color and pulse Doppler will be employed in all of our subjects. Baseline left ventricular function, systolic as well as diastolic, will be quantified.
16244822|NCT01048112|Biological|Campylobacter jejuni strain CG8421|Single oral dose of Campylobacter jejuni strain CG8421 in sodium bicarbonate buffer
16244823|NCT01048099|Procedure|PRO Onc Assay and Treatment|Patients with HER2-negative metastatic breast cancer will be identified, and blood specimens will be obtained from each participant. The PRO Onc Assay will be performed on CTCs isolated from these specimens. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay.
16244981|NCT01046864|Drug|Leucovorin|IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
16244826|NCT01048086|Drug|Retinoic Acid|160 mg, given orally, divided BID on Days 1-4 of each cycle for 4 cycles. Each cycle will be six weeks in duration. Dose will be adjusted to 5.33 mg/kg/day divided BID for children <12 kg.
16244827|NCT01048086|Drug|Placebo|Placebo will be given in the same manner as retinoic acid in capsules that look identical.
16244828|NCT01048060|Procedure|Bone marrow specimen banking|
16244829|NCT01048047|Drug|aliskiren/amlodipine|aliskiren 300 mg /amlodipine 10 mg
16244830|NCT01048034|Drug|Azacitidine|100 mg / m(2) subcutaneously day 1-5 every 4 weeks for 6 cycles. Another three cycles will be given together with epo for those not responding to the first 6 cycles of Azacitidine
16244831|NCT01048034|Drug|Erythropoetin|For those patients not responding to Azacitidine alone, the combination of Azacitidine and erythropoetin 60 000 U / week for 16 weeks will be given.
16244832|NCT01048021|Procedure|Supraclavicular Block|"Baseline values of forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow rates (PEFR) will be measured in both the sitting and supine position. Ultrasound-guided supraclavicular brachial plexus blocks will be performed in the supine position with a Pajunk 22g block needle and nerve stimulator. The patients will receive local anesthetic injection with 15 mL of 0.75% Bupivicaine. A maximum of 3 cc of 5% Dextrose will be utilized as contrast to confirm needle tip placement and fluid spread prior to injection of the local anesthetic.
~At 60 minutes post-injection, FEV1, FVC, and PEFR measurements will be taken in the sitting and supine position."
16244833|NCT01048008|Drug|DM-CHOC-PEN|"DM-CHOC-PEN will be dosed @ 39 mg/M2, escalated in 1-patient cohorts at 40% dosage.
~At the 1st DLT - expand to 3-6 patient cohorts/dose with escalations at 33% increments.
~The MTD will be where 2 DLTs are noted and the study is discontinued."
16244834|NCT01047995|Drug|Raltegravir plus Darunavir/ritonavir|"Phase 1, all subjects (n = 24): Raltegravir 400 mg twice daily for 21 days
~Phase 2 Group 1 (n = 12): Darunavir/ritonavir 800/100 mg once daily plus raltegravir 400 mg twice daily for 14 days
~Phase 3, all subjects (n = 24): Darunavir/ritonavir 800/100 mg once daily for 14 days."
16244835|NCT01047995|Drug|Raltegravir plus Darunavir/ritonavir|"Phase 1, all subjects (n = 24): Raltegravir 400 mg twice daily for 21 days
~Phase 2
~Group 2 (n = 12): Darunavir/ritonavir 800/100 mg once daily plus raltegravir 800 mg once daily for 14 days
~Phase 3, all subjects (n = 24): Darunavir/ritonavir 800/100 mg once daily for 14 days."
16244836|NCT01047982|Dietary Supplement|myo-inositol|myo-inositol 2 grams plus folic acid 400 mcg twice a day
16244837|NCT01047982|Other|folic acid 400 mcg|2 pills a day
16244838|NCT01047969|Drug|Adjuvant Chemotherapy|If after MRI + FDG-PET 8 weeks post CRT the patient shows no visible tumour or further regression adjuvant chemotherapy will be considered.
16244839|NCT01047969|Procedure|Surgery|If after MRI + FDG-PET 8 weeks post CRF no further regression or growth of disease occurs the patient will be referred for surgery.
16244840|NCT01047956|Drug|Methadone; NAC|Methadone NAC
16244841|NCT01047956|Drug|Methadone|Methadone
16244842|NCT01047943|Drug|Topical application of STA-21 ointment for treatment of psoriasis|
16244843|NCT01047930|Behavioral|Exercise|"Each 3-day experimental period will include one of the following conditions:
~Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time;
~Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings;
~No exercise - subject will watch television or read and they will be required to remain sedentary."
16244844|NCT01047917|Behavioral|Meditation DVD|Participants will undergo a one-hour group instruction session in meditation held by Dr. Amit Sood. Participants will then receive a DVD to practice the intervention at home daily for a total of 4 weeks. The DVD will have 3 different programs of 5, 15, and 30 minutes each loaded on it with a menu option to choose one of the programs.
16244845|NCT01047904|Device|Acclarent Iontophoresis System|Administration of local anesthesia using the Acclarent Iontophoresis System
16244846|NCT01047891|Drug|Sorafenib|Topotecan 1,25 mg/m²/d administered as an i.v. infusion over 30 minutes once daily on days 1-5, every 21 days and Sorafenib 400 mg orally twice daily (total daily dose 800 mg) administered
16244847|NCT01047852|Procedure|Noninvasive ventilation|NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula
16244848|NCT01047839|Biological|IC51|0.25 ml, 2 i.m. vaccinations at Day 0 and 28
16244849|NCT01047839|Biological|IC51|0.5 ml, 2 i.m. vaccinations at Day 0 and 28
16244850|NCT01047839|Biological|IC51|0.5 ml, 2 i.m. vaccinations at Day 0 and 28
16244851|NCT01047826|Procedure|Minimally Invasive Plate Osteosynthesis|Fractures well be treated with locked plates using M.I.P.O. Technique
16244852|NCT01047826|Procedure|intramedullary tibial Nailing|Fractures well be fixed using intramedullary nails
16244853|NCT01047800|Behavioral|Counseling|"Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician in First and Final visits. Each session lasts for about 15 minutes with the following content:
~First visit: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
~Final visit : prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions."
16244854|NCT01047787|Other|Polysomnography|examination for sleep disorders
16244855|NCT01047774|Dietary Supplement|Isolated soy protein|30-50g of protein powder daily for 2 weeks.
16244856|NCT01047774|Dietary Supplement|Isolated milk protein|30-50g of protein powder daily for 2 weeks.
16244857|NCT01047761|Other|Exercise|"3 month exercise intervention, three days a week Progressive in duration - up to 1 hour daily; Progressive in intensity
~Multi-modal exercise program includes a) aerobic - walking, b) resistive training with therabands and core exercises, and c) breathing exercises"
16244858|NCT01047748|Drug|intra-fetal digoxin injection|Single transabdominal injection of digoxin 1 mg into the fetus
16244859|NCT01047748|Drug|intra-amniotic digoxin injection|Single transabdominal injection of digoxin 1 mg into the amniotic fluid
16245663|NCT01041781|Drug|gemcitabine hydrochloride|Given IV
16244860|NCT01047735|Procedure|Roux-en-Y Gastric Bypass Surgery|Participants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements.
16244861|NCT01047735|Procedure|Laparoscopic Adjustable Gastric Banding|Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes.
16244862|NCT01047735|Behavioral|Lifestyle Weight Loss Intervention|Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors.
16244863|NCT01047722|Drug|Aspirin ingestion followed by doing a Bleeding Volume Test|Patient drinks a glass of Gatorade containing 325 mg of aspirin, then one hour later a bleeding volume test is performed.
16244864|NCT01047722|Procedure|Gatorade Placebo followed by Bleeding Volume Test.|Patient drinks a glass of Gatorade, then one hour later a bleeding volume test is performed.
16244865|NCT01047709|Device|Positional therapy including the use of a special pillow|Avoidance of supine sleep via a special pillow and other measures.
16244866|NCT01047696|Device|Plancha|locally developed chimney stove
16244867|NCT01047683|Drug|AMR101 (ethyl icosapentate)|AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52)
16244868|NCT01047683|Drug|AMR101 (ethyl icosapentate)|AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52)
16244869|NCT01047683|Drug|Placebo|Placebo 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) for 40 weeks (Weeks 13-52)
16244870|NCT01047683|Drug|Placebo|Placebo 2 capsules/day for 12 weeks (Weeks 1-12)
16244871|NCT01047670|Drug|Hydrocortisone|Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion
16244872|NCT01047657|Behavioral|Low caloric diet plus orlistat and sibutramine|All subjetcs
16244873|NCT01047644|Other|Reduced port-flush schedule|3-month port-flushing
16244874|NCT01047631|Behavioral|Functional circuit training and lifestyle counseling|"Tests are performed at the beginning, and repeated after 12 and 24 weeks:
~Measure general fitness levels such as walking, strength and balance.
~Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
~Blood and urine tests and a heart ultrasound.
~Questionnaires & activity measures.
~Group assignment for 12 weeks:
~-Exercise classes & activity guidance: Twice-weekly class that focuses on exercises that are similar to daily activities, such as walking and carrying objects. Obtain customized information and education to help you exercise and follow a low salt diet.
~Follow-up:
~-Monthly phone calls during the 12 week follow up period."
16244875|NCT01047631|Behavioral|Health education and independent walking|"Tests are performed at the beginning, and repeated after 12 and 24 weeks.
~Measure general fitness levels such as walking, strength and balance.
~Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
~Blood and urine tests and a heart ultrasound.
~Questionnaires & activity measures.
~Group assignment for 12 weeks:
~-Health education and walking: Weekly health education classes covering general topics related to heart failure, like medications, diet and exercise. Receive a pedometer for an at-home walking program.
~Follow-up:
~-No follow up support"
16244876|NCT01047605|Drug|Neurapas balance|6 tablets single dose
16244877|NCT01047605|Drug|Pascoflair 425 mg|3 tablets , single dose
16244878|NCT01047605|Drug|P-Tabletten weiß|3 tablets, single dose
16244879|NCT01047592|Drug|sarcosine|sarcosine, 2 g/d , oral, for 12 weeks
16244880|NCT01047592|Drug|sarcosine+ BE|sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
16244881|NCT01047592|Drug|placebo|placebo,oral, for 12 weeks
16244882|NCT01047579|Drug|Rivastigmine transdermal|
16244883|NCT01047566|Drug|Dronedarone|Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
16244884|NCT01047566|Drug|Beta blocker or calcium antagonist or digoxin|Dose increase of beta blocker or calcium antagonist or digoxin
16244885|NCT01047553|Drug|Formoterol (OT)|9 μg/dose, Inhaled, twice daily for 52 weeks
16244886|NCT01047540|Drug|AIC316|Oral administration
16244887|NCT01047540|Drug|AIC316|Oral administration
16244888|NCT01047540|Drug|AIC316|Oral administration
16244889|NCT01047540|Drug|AIC316|Oral administration
16244890|NCT01047540|Drug|Placebo|Oral administration
16244891|NCT01047527|Drug|Transdermal nicotine patch|Transdermal nicotine, 21mg/day
16244892|NCT01047514|Behavioral|Chronic Disease Self-Management Online Workshop|6 week, online, small group self-management workshop
16244893|NCT01047501|Drug|AMR101 (ethyl icosapentate)|AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
16244894|NCT01047501|Drug|AMR101 (ethyl icosapentate)|AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks
16244895|NCT01047501|Drug|Placebo|Placebo 4 capsules/day for 12 weeks
16244896|NCT01047501|Drug|Placebo|Placebo 2 capsules/day for 12 weeks
16244897|NCT01047488|Drug|Imipramine|Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
16244898|NCT01047488|Drug|Pregabalin|Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
16245664|NCT01041781|Drug|pemetrexed disodium|Given IV
16244899|NCT01047488|Drug|Imipramine, pregabalin|Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
16244900|NCT01047488|Drug|Placebo|Placebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks
16244901|NCT01047475|Drug|MB-6|6# TID with meal
16244902|NCT01047475|Drug|Placebo|6# TID with meal
16244903|NCT01047462|Procedure|Surgery for acute perforated diverticulitis|Primary resection vs laparoscopic lavage
16244904|NCT01047449|Procedure|No-touch SVG harvest vs conventional SVG harvest technique|Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
16244905|NCT01047449|Dietary Supplement|Fish oil supplementation vs placebo|Fish oil supplementation [1g tablets (55% fish oils - EPA:DHA 33%:22%)] taken twice daily for 1 year post-op
16244906|NCT01047436|Drug|Quinine|20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
16244907|NCT01047436|Drug|Artemether|Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
16244908|NCT01047423|Drug|Simvastatin|40mg encapsulated once daily for 12 weeks
16244909|NCT01047423|Drug|Placebo|Encapsulated oral once daily for 12 weeks
16244910|NCT01047410|Other|Exercise intervention|Patients assigned to the exercise intervention participate in a 12 weeks lasting, intensive, standardized and supervised physical training program which consists of a combination of endurance and strength training. After completion of the training program, patients receive an individual sport- and physical activity advice and lifestyle coaching.
16244911|NCT01047410|Other|Exercise intervention and dietary advice|The exercise intervention in this group is identical to the exercise-only group. The nutritional intervention runs throughout the entire 15 month intervention. The nutritional intervention aims to critically discuss pre-transplantation nutritional habits, and to set goals for healthier, better quality nutrition to prevent over eating and weight gain. These goals are set together with the subject to facilitate an autonomy supportive coaching climate.During the dietary consults, special attention goes out to saturated fat intake, whole-wheat and high fibre foods, fruit and vegetable intake, dietary salt consumption, and the use of energy-rich beverages such as soda, dairy drinks and fruit juices.
16244912|NCT01047397|Drug|1278863A|25mg, 50mg, 100mg
16244913|NCT01047397|Drug|Placebo|matching placebo
16244914|NCT01047384|Procedure|acupuncture-moxibustion therapy|
16244915|NCT01047384|Procedure|Regular therapy|
16244916|NCT01047358|Drug|Aromasin|25 mg table QD
16244917|NCT01047358|Drug|Aromasin|25 mg table QD
16244918|NCT01047345|Biological|V503|V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension
16244919|NCT01047345|Biological|Placebo to V503|Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
16244920|NCT01047332|Device|Partially Covered Wallstent|Partially covered wallstent
16244921|NCT01047332|Device|Uncovered Wallstent|Uncovered wallstent
16244922|NCT01047319|Drug|Laquinimod|One capsule containing 0.6 mg laquinimod to be administered orally once daily.
16244923|NCT01047306|Other|assessment|Physical, developmental, neurological, behavioral, and neurocognitive assessments
16244924|NCT01047293|Drug|RAD001|"RAD001 (everolimus) is a novel oral derivative of rapamycin.
~RAD001 is being investigated as an anticancer agent based on its potential to act:
~Directly on the tumor cells by inhibiting tumor cell growth and proliferation
~Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced proliferation of endothelial cells). The role of angiogenesis in the maintenance of solid tumor growth is well established, and the mTOR pathway has been implicated in the regulation of tumor production of proangiogenic factors as well as modulation of VEGFR signaling in endothelial cells."
16244925|NCT01047293|Drug|FOLFOX|FOLFOX regimens combine oxaliplatin and leucovorin with bolus and infusional 5-fluorouracil (5-FU). 1 Oxaliplatin is a DNA cross-linking agent consisting of a platinum ion chelated with1, 2-diaminocyclohexane (DACH) and an oxalate ligand. It undergoes spontaneous activation in aqueous solutions via displacement of the labile oxalate ligand by water. The activated compounds bind with DNA, resulting in inter- and intra-strand platinum-DNA crosslinks. 5-FU is an anti-metabolite that blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, causing thymidine-less cell death in rapidly growing cells. Leucovorin is reduced folic acid that modulates the activity of 5-FU by stabilizing the ternary 5-FdUMP/ thymidylate synthetase complex. Side effects associated with FOLFOX include neuropathy including pharyngo-laryngodysesthesia, diarrhea, nausea, vomiting, and mild myelosuppression.
16244926|NCT01047293|Drug|Bevacizumab|Bevacizumab, a monoclonal antibody directed against VEGF (vascular endothelial growth factor) has been studied in a multitude of Phase I, II, and III clinical trials in more than 5000 patients in multiple tumor types. Phase III data in metastatic cancers
16244927|NCT01047280|Dietary Supplement|Clarinol G-80 ® treatment|dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).
16244928|NCT01047280|Dietary Supplement|Safflower oil|3.5 g/d of safflower oil
16244929|NCT01047280|Dietary Supplement|G-c9, t11|3.5 g/day of c9, t11 CLA
16244930|NCT01047254|Drug|Elontril|flexible dose of Bupropion 150-300 mg
16244931|NCT01047254|Drug|placebo|
16244932|NCT01047241|Drug|Intranasal sufentanil/ketamine|Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
16244933|NCT01047215|Drug|Aripiprazole; Quetiapine|Aripiprazole Quetiapine
16244934|NCT01047202|Biological|Pandemic influenza A/H1N1 vaccine|Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
16244935|NCT01047202|Biological|Pandemic influenza A/H1N1 vaccine|Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
16244936|NCT01047202|Biological|Seasonal trivalent vaccine|Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
16244937|NCT01047189|Drug|clindamycin phosphate 1.2% and tretinoin 0.025%|applied once daily for 12 weeks
16244938|NCT01047189|Drug|clindamycin 1% gel|Topical clindamycin applied each morning for 12 weeks
16244939|NCT01047189|Drug|tretinoin 0.025% cream|Tretinoin 0.025% cream each evening for 12 weeks
16244940|NCT01047137|Behavioral|Psychological Stress Intervention|Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques focusing on relaxation, mindfulness, emotion regulation and acceptance and willingness.
16244941|NCT01047137|Behavioral|General Supportive Therapy|There is no focus on stress intervention.
16244942|NCT01047124|Other|Specialist Mood Disorders Team|The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs.
16244943|NCT01047111|Procedure|Esophagectomy|Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
16244944|NCT01047098|Dietary Supplement|Iron|Iron as iron sulfate
16244945|NCT01047098|Dietary Supplement|Iron|Iron as iron sulfate
16244946|NCT01047098|Dietary Supplement|Placebo|Placebo capsule
16244947|NCT01047085|Procedure|impedance pH measurement|Impedance pH measurement: Impedance-pH is a recently developed technique used to monitor all kinds of reflux (gas, liquid, acides and non-acides), reflux level and the clearance period of the esophagus.
16244948|NCT01047072|Drug|fludarabine phosphate|Given IV
16244949|NCT01047072|Radiation|total-body irradiation|Undergo total-body irradiation
16244950|NCT01047072|Drug|tacrolimus|Given orally
16244951|NCT01047072|Drug|mycophenolate mofetil|Given orally
16244952|NCT01047072|Biological|rituximab|Given IV
16244953|NCT01047072|Drug|cyclophosphamide|Given orally
16244954|NCT01047072|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo transplantation
16244955|NCT01047072|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
16244956|NCT01047059|Drug|Erlotinib, Bevacizumab|Erlotinib 150mg/d d1-d43 p.o. Bevacizumab 15mg/kg b. w. d1, d22, d43 i.v.
16244957|NCT01047059|Drug|Fluoro-D-glucose|Tracer for PET imaging
16244958|NCT01047059|Drug|Fluoro-L-thymidine|FLT-PET tracer for imaging
16244959|NCT01047059|Drug|Gadolinium-DPTA|Contrast agent for DCE-MRI imaging
16244960|NCT01047046|Other|Retrospective chart review|"This study is a retrospective chart review including all patients who received surgical placement of a SNM device with Dr. Noblett from 2001 to the present.
~The following data will be collected from patient charts: age at time of surgery, gravidity/parity, body mass index, pre-existing medical conditions/surgical history, current medications, menopausal status, form and severity of OAB symptoms, other previously or currently used interventions, method of SNM device placement, observed motor/sensory response, percent improvement of symptoms, follow-up OAB symptoms, frequency of InterStim settings adjustments, adverse events, significant changes in health, and incidence/reason for drop out."
16244961|NCT01047033|Behavioral|Health education|30 minutes of a health education module delivered to clients by loan officers during monthly repayment meetings, over the course of 8 months.
16244962|NCT01047033|Other|Microcredit|Small loans administered to clients through the collaborating microcredit organization, to be repaid monthly over the course of six months in the context of monthly loan group meetings.
16244963|NCT01047007|Drug|MK-1775 20 mg|MK-1775 20 mg capsule administered orally on days 1-5 of a 21 day cycle.
16244964|NCT01047007|Drug|5-FU 1000 mg/m^2/day|5-FU 1000 mg/m^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle
16244965|NCT01047007|Drug|CDDP|CDDP 60 mg/m^2 to 100 mg/m^2 administered as an IV infusion on Day 1.
16244966|NCT01047007|Drug|MK-1775 65 mg|MK-1775 65 mg capsule administered orally on days 1-5 of a 21 day cycle.
16244967|NCT01046994|Procedure|biliopancreatic diversion|biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve
16244968|NCT01046994|Drug|antidiabetics|patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice
16244969|NCT01046981|Procedure|Tumescent Antibiotic Delivery of cefazolin with or without metronidazole|TAD of cefazolin with or without metronidazole followed by sequential serum and interstitial fluid samples over 14 to 24 hours for antibiotic concentrations
16244970|NCT01046981|Procedure|Intravenous Antibiotic Delivery|Intravenous antibiotic delivery of cefazolin with or without metronidazole followed by sequential serum sampling for antibiotic concentration of subsequent 12 to 24 hours.
16244971|NCT01046968|Dietary Supplement|Lepticore|300 mg twice daily
16244972|NCT01046955|Drug|Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab|comparison of induction therapies.
16244973|NCT01046942|Drug|Clopidogrel+acetylsalicylic acid|loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery
16244974|NCT01046942|Drug|acetylsalicylic acid|aspirin 75 mg daily, started 6-24 hours after surgery
16244975|NCT01046929|Dietary Supplement|limonene|oral dosing at 2 gram QD
16244976|NCT01046916|Drug|TAK-700|TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule
16244977|NCT01046903|Drug|Fragmin® (Dalteparin Sodium)|Administered per prescribing physician
16244978|NCT01046890|Drug|Echinacea|darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
16244979|NCT01046877|Device|Tympanostomy Tube Delivery System|Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
16244980|NCT01046864|Drug|5-FU|IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity
16244983|NCT01046864|Drug|Irinotecan|IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity
16244984|NCT01046864|Drug|Brivanib|Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity
16244985|NCT01046864|Drug|Brivanib|Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity
16244986|NCT01046864|Drug|Brivanib|Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity
16244987|NCT01046851|Drug|Nopan|Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
16244988|NCT01046851|Drug|Placebo|Placebo in a manner similar to the active comparator
16244989|NCT01046838|Drug|Sildenafil|40 mg three times daily for 9 weeks
16244990|NCT01046838|Drug|Placebo|tablet 3 times daily for 9 weeks
16244991|NCT01046825|Drug|COPAD|Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF
16244992|NCT01046825|Drug|COP, COPD M3, CYM|GROUP B Treatment Details Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3 Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, IT medications, G-CSF, Rituximab Consolidation (2 cycles): Methotrexate, Leucovorin, Cytarabine, IT medications, G-CSF, Rituximab
16244993|NCT01046825|Drug|COP, COPADM8, CYVE|"Treatment: Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3.
~COP Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications, Leucovorin.
~COPADM8 Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, Rituximab, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, Rituximab, G-CSF.
~Maintenance No.1: Vincristine, Prednis(ol)one, Cyclophosphamide, Methotrexate, Leucovorin, Doxorubicin, IT medications, G-CSF.
~Maintenance No.2: Cytarabine, Etoposide, G-CSF, IT Medications. Maintenance No.3: Vincristine, Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF, IT Medications.
~Maintenance No. 4: Cytarabine, Etoposide, G-CSF, IT Medications."
16244994|NCT01046812|Drug|Caphosol|Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.
16244995|NCT01046799|Drug|Entecavir|Entecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis
16244996|NCT01046786|Biological|Umbilical Cord Blood Mononuclear Cell|The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
16244997|NCT01046786|Drug|Methylprednisolone|30 mg/kg methylprednisolone
16244998|NCT01046786|Drug|Lithium|oral lithium, titrated to maintain 0.6-1.0 mM serum level
16244999|NCT01046773|Drug|Cholecalciferol|Children less than 35 kg will receive 2,000 IU oral cholecalciferol daily for 6 months.
16245000|NCT01046773|Drug|Cholecalciferol|Children 35 kg or greater will receive 4,000 IU oral cholecalciferol daily for 6 months.
16245001|NCT01046760|Behavioral|Language Assessment|Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.
16245002|NCT01046747|Procedure|Placement of external fixation pins|The fractures will be treated according to standard of care. If the external fixation is to be used as a staging procedure, then this will be removed and an internal fixation procedure will be performed. The pin sites will be checked daily according to standard of care. All individuals involved in the examination of the pin sites will receive a standardized training in the grading of pin tract infection and loosening. Each pin site will be graded individually by three persons to evaluate internal accuracy of our grading. Pin tract infections will be first graded as yes or no, and then graded according to the Modified Joglekar Classification (Grade 0-4, Grade 0: no erythema, no drainage; Grade 1: erythema, no drainage OR no erythema with serous drainage; Grade 2: erythema, serous drainage; Grade 3: erythema, purulent drainage; Grade 4: gross pin loosening). Pin loosening will be evaluated at the time of pin removal and graded as either yes or no.
16245003|NCT01046721|Drug|Exenatide|single dose of 5 microg Exenatide. Subcutaneous administration
16245004|NCT01046721|Drug|Saline|subcutaneous administration of 0.9% saline solution (0.02 ml)
16245005|NCT01046708|Drug|micronized progesterone|600mg in 3 separate doses per day
16245006|NCT01046695|Device|TENS Unit|TENS is a method of pain relief that uses a battery operated electronic device with cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. The TENS Unit is a low voltage system that will only be used to a level to create alternative to pain sensation and will not create muscle response.
16245007|NCT01046682|Drug|Salsalate|Salsalate 2 grams orally twice a day for 13 weeks. This is the maximum dosage. During the initial 9 days of the study salsalate dose will be titrated to reach this goal dosage.
16245008|NCT01046669|Device|TORAYMYXIN PMX-20R (PMX cartridge)|TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).
16245009|NCT01046669|Other|Standard medical care for septic shock|Standard medical care for septic shock
16245010|NCT01046656|Dietary Supplement|Lactobacillus reuteri (DSM 17938)|5 drops once daily (10(8) CFU) for the entire duration of hospital stay
16245011|NCT01046643|Drug|Estradiol (E2)|One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days; followed by one Progesterone (200mg) once a day, at the same time each day, for 10 days to slough endometrial lining; followed by one Placebo capsule once a day, at the same time each day, for 90 days.
16245012|NCT01046643|Drug|Progesterone (P10) x90|One Progesterone capsule (200mg) once a day, at the same time each day, for 90 days; followed by one Placebo capsule (to mirror Progesterone capsule to slough endometrial lining in Estradiol recipients) once a day, at the same time each day, for 10 days ; followed by one Placebo capsule once a day, at the same time each day, for 90 days.
16245013|NCT01046643|Drug|Progesterone (P10) x10|One Progesterone (200mg) capsule once a day for 10 days, to slough endometrial lining for patients taking Estradiol. Patients taking Progesterone will take an equivalent Placebo capsule during this time period.
16245014|NCT01046630|Drug|AZD6765|single infusion
16245015|NCT01046630|Drug|Ketamine|single infusion
16245016|NCT01046630|Drug|Placebo|single infusion
16245017|NCT01046617|Dietary Supplement|Lactobacillus reuteri (DSM 17938)|5 drops once daily (10(8) CFU) for 21 days
16245018|NCT01046604|Drug|Lovaza group|Patients who are scheduled for mitral valve repair surgery at least 3 weeks removed from the initial consult will be recruited to take 4 capsules of Lovaza (omega 3 fatty acids) daily, for 3 weeks prior to their surgery.
16245019|NCT01046591|Procedure|Polysomnography|Overnight sleep studies will be performed on all children.
16245020|NCT01046578|Drug|Letrozole|20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 12 mm in diameter
16245021|NCT01046578|Drug|Letrozole|20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 18 mm in diameter
16245022|NCT01046578|Drug|Letrozole|20 mg, one tablet a day for one day, starting 24-48 hours after ovulation of the dominant follicle is observed
16245023|NCT01046578|Drug|Letrozole|2.5 mg, one tablet a day for five days, starting 24-48 hours after ovulation of the dominant follicle is observed
16245024|NCT01046578|Drug|Letrozole|2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter
16245025|NCT01046578|Drug|Letrozole|2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter
16245026|NCT01046565|Drug|adapalene cream 0.1%|adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks
16245027|NCT01046565|Drug|adapalene lotion 0.1%|adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
16245028|NCT01046552|Procedure|preoperative ERCP and LC|preoperative ERCP followed by LC
16245029|NCT01046552|Procedure|Intraoperative ERCP and LC|LC and intraoperative ERCP
16245030|NCT01046539|Drug|RDC-0313 + Buprenorphine|1 and 4 mg (1 dose for each) + 8 mg
16245031|NCT01046539|Drug|Placebo|0 mg
16245032|NCT01046500|Dietary Supplement|myo-inositol|2 grams twice a day
16245033|NCT01046500|Drug|Metformin|pill, 250 mg, twice a day
16245034|NCT01046487|Drug|Imatinib mesylate, Cyclophosphamide (Dosing level 1 )|"CYCLE 1 (42 days):
~Day 1 to 14 Imatinib mesylate : 400 mg/day, per os
~Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os
~NEXT CYCLE (28 days):
~Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os"
16245035|NCT01046487|Drug|Imatinib mesylate, Cyclophosphamide (Dosing level 2)|"CYCLE 1 (42 days):
~Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
~Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
~NEXT CYCLE (28 days):
~Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os"
16245036|NCT01046487|Drug|Imatinib mesylate, Cyclophosphamide (Dosing level 3)|"CYCLE 1 (42 days):
~Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
~Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
~NEXT CYCLE (28 days):
~Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os"
16245037|NCT01046487|Procedure|Blood sampling|"ONLY FOR CYCLE 1, at day 15 and day 28 :
~11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)"
16245038|NCT01046474|Behavioral|lifestyle|"Based on beliefs and behaviors of children sections of education will be delivered via classroom activities.
~Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
~Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted."
16245039|NCT01046461|Drug|Ramosetron, Aprepitant, Dexamethasone|"Day 1:
~Aprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy
~Day 2 - 3:
~Aprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning
~Day 4 Dexamethasone 8 mg PO. in the morning"
16245040|NCT01046435|Procedure|metronidazole and amoxicillin|Metronidazole 250 mg three times a day per 7 days
16245041|NCT01046435|Procedure|Two placebos|Two placebos 3 times a day for 7 days
16245042|NCT01046422|Drug|BMS-770767|Capsule, Oral, 15mg, Active, Daily, 28 days
16245043|NCT01046422|Drug|BMS-770767|Capsule, Oral, 50mg, Active, Daily, 28 days
16245044|NCT01046422|Drug|BMS-770767|Capsule, Oral, 150mg, Active, Daily, 28 days
16245045|NCT01046422|Drug|BMS-770767|Capsule, Oral, 50mg BID, Active, Daily, 28 days
16245046|NCT01046422|Drug|Placebo|Capsule, Oral, 0mg, Daily, 28 days
16245047|NCT01046422|Drug|Metformin|Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
16245048|NCT01046409|Other|Measuring collateral flow|Measuring collateral flow using pressure and/or velocity coronary wire
16245049|NCT01046396|Drug|adapalene cream 0.1% and adapalene lotion 0.1%|adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks
16245050|NCT01046396|Drug|adapalene lotion 0.1%|adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
16245051|NCT01046383|Dietary Supplement|IMN1207|20 grams of IMN1207 per day for 40 weeks.
16245052|NCT01046383|Dietary Supplement|Casein|20 grams of Casein per day for 40 weeks
16245053|NCT01046370|Behavioral|Amygdala Retraining Program|Mind-body intervention.
16245054|NCT01046357|Drug|AZD7687|Single oral dose
16245055|NCT01046357|Drug|Placebo|Single oral dose
16245056|NCT01046318|Drug|OPC-262|OPC-262 5 mg will be orally administered once daily fro 52 weeks.
16245057|NCT01046305|Behavioral|Interview & Questionnaires|30 Minute Interview about what it is like to have CML, followed by symptom questionnaire, quality-of-life questionnaire, and demographic questions taking another 10 minutes for all 3 questionnaires.
16245058|NCT01046305|Behavioral|Rating Questionnaire|Questionnaire developed in Part 1 to rate the relevance of symptom items, given to 3-5 physicians, 3-5 nurses, 2-4 patients and their family caregivers, taking about 10 minutes.
16245059|NCT01046305|Behavioral|MDASI-CML Questionnaire|Patient questionnaires about CML symptoms over 1 year, completed in person or using Interactive Voice Response (IVR) system every 2 weeks.
16245060|NCT01046292|Drug|Ginkgo biloba|The participants will be randomly allocated to either the intervention group or the placebo control group at a ratio of 1:1. After six months, GBE will be administered to all participants for another 6 months for free. The daily administered dose (taken with meals in the morning and evening) will consist of either twice-daily 1 capsule of Symfona® forte 120mg GBE or identically appearing placebo.
16245061|NCT01046279|Drug|Bevacizumab|Patients with histological diagnosis of anaplastic astrocytoma (WHO Grad III) or Glioma (WHO Grad IV) assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons
16245062|NCT01046266|Drug|RO5083945|700mg iv weekly
16245063|NCT01046266|Drug|cetuximab|400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses
16245064|NCT01046253|Drug|Lansoprazole|30 mg Delayed-Release Capsules
16245065|NCT01046253|Drug|Prevacid®|30 mg Delayed-Release Capsule
16245066|NCT01046240|Drug|Palonosetron|Palonosetron 3 mg administered SC or IV
16245067|NCT01046227|Biological|Influenza A (H1N1) 2009 monovalent vaccine, inactivated|Serology study before and after Influenza A (2009) monovalent vaccine, inactivated
16245068|NCT01046214|Drug|Bupropion HCl|Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet
16245069|NCT01046214|Drug|Bupropion HCl|Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet
16245070|NCT01046188|Other|Knowledge Questionnaire|Administered before and after teaching intervention
16245071|NCT01046188|Other|Perceived Stress Scale|Administered before and after teaching intervention
16245072|NCT01046188|Other|Satisfaction questionnaire|Administered after the intervention and at study completion
16245073|NCT01046188|Other|Web-based IVF teaching|Web-based IVF teaching
16245074|NCT01046188|Other|Didactic lecture|Didactic lecture
16245075|NCT01046175|Procedure|Air-stacking with a manual resuscitator|Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator
16245076|NCT01046175|Procedure|Air-stacking with ventilator|Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator
16245077|NCT01046162|Drug|Alprazolam|Single tablet
16245078|NCT01046162|Drug|Alprazolam|Single tablet
16245079|NCT01046149|Behavioral|Breathing training|Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
16245080|NCT01046149|Behavioral|Stress management|Cognitive reconstructive strategies for stress management
16245081|NCT01046136|Drug|guaifenesin (Mucinex)|bid 7 days
16245082|NCT01046136|Drug|placebo|bid 7 days
16245083|NCT01046123|Radiation|whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy|Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days.
16245084|NCT01046110|Drug|insulin degludec|Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.
16245085|NCT01046110|Drug|sitagliptin|Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks
16245086|NCT01046097|Biological|Synflorix™|Intramuscular administration of three doses/two doses/one dose of primary vaccination/the booster dose/ catch-up dose(s) of Synflorix according to local prescribing information.
16245087|NCT01046084|Drug|Lansoprazole|30 mg Delayed-Release Capsule
16245088|NCT01046084|Drug|Prevacid®|30 mg Delayed-Release Capsule
16245089|NCT01046071|Procedure|transversus abdominis plane block|UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.
16245090|NCT01046071|Procedure|TAP block placebo|UL-guided TAP block with 20 ml of saline bilaterally, single dose.
16245091|NCT01046058|Drug|TMC435|150 mg (two 75-mg capsules) orally (by mouth) once daily for 7 days
16245092|NCT01046045|Drug|everolimus|everolimus at an initial daily loading dose between 1 and 4 mg dose of everolimus will be adjusted to maintain a trough everolimus level between 5 and 12 ng/mL
16245093|NCT01046032|Drug|Metformin|Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.
16245094|NCT01046032|Drug|Placebo|Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.
16245095|NCT01046006|Drug|Bortezomib, Rituximab, Dexamethasone|"Bortezomib as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1.
~On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each 35-day cycle.
~Dexamethasone IV 40 mg will be given on cycles 2 and 5 on days 1,8,15,22 Rituximab IV will be given on cycles 2 and 5, 375 mg/m2, on days 1,8,15,22 iv"
16245096|NCT01045993|Device|Heat Device|8-Hour Heatwrap
16245097|NCT01045993|Device|Sham Device|Inactive wrap worn for 8 hours
16245098|NCT01045993|Drug|marketed analgesic|2 x 200 mg ibuprofen tablets
16245099|NCT01045993|Drug|Placebo|2 x placebo tablets
16245100|NCT01045980|Drug|Bioimpedance and Vitamin D|Intervention subjects will undergo BIA assessment monthly for 1 year, and then every 3 months until the end of the planned 3-year study. Protocolized interventions to achieve euvolemia will occur based on the BIA result and they include sodium restriction, addition of diuretics, use of icodextrin, and additional rational changes to the PD prescription.
16245101|NCT01045980|Drug|Usual care and placebo|Usual care (not bioimpedance guided volume management) and Placebo
16245102|NCT01045980|Drug|Usual care and Vitamin D|Usual care (not bioimpedance guided volume management) and Vitamin D
16245103|NCT01045980|Device|Bioimpedance and Placebo|Bioimpedance guided volume management and Placebo
16245104|NCT01045967|Drug|Lansoprazole|30 mg delayed-release Capsule
16245105|NCT01045967|Drug|Prevacid®|30 mg delayed-release Capsule
16245106|NCT01045954|Drug|Lispro Insulin and glargine insulin|Continuous glucose sensor will be inserted. Subject will be on an isocaloric diet and CGM downloaded daily. Insulin basal and bolus will be adjusted based upon treatment goals until goals reached
16245107|NCT01045941|Drug|Gemcitabine/Gemzar|Six cycles of Gemcitabine will be given. Each cycle of Gemcitabine comprises of Gemcitabine 1000 mg/m2 as a 30 minute infusion once weekly for 3 weeks with a fourth week off.
16245108|NCT01045941|Procedure|Laparoscopic Distal pancreatectomy|Laparoscopic resection of the distal pancreas
16245109|NCT01045928|Drug|lenalidomide|Given orally
16245110|NCT01045928|Biological|rituximab|Given IV
16245111|NCT01045928|Genetic|polymerase chain reaction|Correlative study
16245112|NCT01045928|Genetic|nucleic acid sequencing|Correlative study
16245113|NCT01045928|Genetic|polymorphism analysis|Correlative study
16245114|NCT01045928|Other|flow cytometry|Correlative study
16245115|NCT01045928|Other|laboratory biomarker analysis|Correlative study
16245116|NCT01045915|Biological|naked DNA coding for protein AMEP|2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer
16245117|NCT01045902|Drug|Avelox (Moxifloxacin, BAY12-8039)|Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
16245118|NCT01045902|Drug|Sulbactam/Ampicillin|Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
16245119|NCT01045889|Other|Rituximab and CHOP regimen + PBSCT|
16245120|NCT01045876|Drug|Dexamethasone|One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
16245121|NCT01045876|Other|Placebo|2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
16245122|NCT01045863|Drug|PF-03382792 Cohort 1|First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
16245123|NCT01045863|Drug|PF-03382792 Cohort 2|Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
16245124|NCT01045863|Drug|PF-03382792|Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
16245125|NCT01045863|Drug|Food Effect cohort|Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.
16245126|NCT01045863|Drug|CSF cohort|Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.
16245127|NCT01045837|Drug|Prednisolone and Gluten free diet|Gluten free diet and Oral Prednisolone in a dose of 1 mg/ kg will be given for a period of 4 weeks, thereafter Gluten free diet alone will be continued
16245128|NCT01045837|Behavioral|Gluten free diet|Only gluten free diet will be given in this group
16245129|NCT01045811|Behavioral|Breathing training|Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
16245130|NCT01045811|Behavioral|Stress management|Cognitive reconstructive strategies for stress management
16245131|NCT01045798|Drug|Caspofungin acetate|70 mg of caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
16245132|NCT01045798|Drug|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
16245133|NCT01045772|Drug|rilonacept|160mg of rilonacept 1x/week
16245134|NCT01045746|Device|Stochastic resonance whole-body vibration A|over four weeks, three times a week with 5 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.
16245135|NCT01045746|Device|Stochastic resonance whole-body vibration b|over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 5 Hz, Noise 4.
16245136|NCT01045733|Device|AcrySof IQ Toric IOL|AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
16245137|NCT01045733|Device|AcrySof IQ Aspheric IOL|AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
16245138|NCT01045733|Procedure|Limbal Relaxing Incision (LRI)|An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.
16245139|NCT01045720|Drug|Suo Quan Wan, Wu Lin San|Suo Quan Wan Wu Lin San Placebo 2/daily
16245140|NCT01045720|Drug|Placebo|Placebo (starch)
16245141|NCT01045707|Drug|insulin degludec/insulin aspart|Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
16245142|NCT01045707|Drug|insulin glargine|Injected s.c. (under the skin) once daily. Dose was individually adjusted.
16245143|NCT01045694|Drug|Botulinum Toxin Type A|One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
16245144|NCT01045694|Drug|Steroid - Triamcinolone Acetonide|Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
16245145|NCT01045694|Drug|Lidocaine|Single injection of 1 - 3 mL of 2% Lidocaine
16245146|NCT01045681|Drug|Bendamustine, Velcade and Dexamethasone|Bendamustine : 70 mg/m2 iv on D1 and 8, for each cycle Velcade : 1.3 mg/m2 iv on D1, 8, 15 and 22, for each cycle Dexamethasone : 20 mg/day po on D1, 8, 15 and 22, given prior to Bendamustine and Velcade
16245147|NCT01045668|Procedure|Radiofrequency Catheter Ablation (RFCA)|RFCA of clinical VT
16245148|NCT01045668|Procedure|Radiofrequency Catheter Ablation (RFCA)|RFCA of clinical VT as well as VT substrates
16245149|NCT01045655|Behavioral|MOMCare|8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
16245150|NCT01045642|Drug|Omeprazole|Omeprazole Magnesium DR Capsules 20 mg
16245151|NCT01045629|Other|Consent form education|Randomly stratified schizophrenic patients group, some receive consent form education, the others not.
16245191|NCT01045291|Device|Cardiac Resynchronization Therapy-Defibrillator (CRT-D)|Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
16245430|NCT01043354|Behavioral|framing effects intervention|6 monthly telephone-delivered counseling sessions based on prospect theory
16245152|NCT01045590|Drug|titration|Patients in the glibenclamide plus placebo treatment group Patients in the glibenclamide plus placebo treatment group who have FPG < 270mg/dL after the glibenclamide 5mg om run-in will continue to receive glibenclamide 5mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of < 7%. If the HbA1c is > 7%, the dose of glibenclamide will be escalated in the following sequence: from 5mg om, to 5mg om, 2.5mg on, to 5mg bd and 7.5mg om, 5mg on, to 7.5mg bd. The maximum total daily dose will not exceed 15 mg. A downward titration of glibenclamide using the above sequence in the reverse order can be used to maintain normoglycemia at any visit. Once the target HbA1c level of < 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is > 7% for 2 subsequent visits, the patient will be withdrawn from the study.
16245153|NCT01045590|Drug|titration|Patients in the glibenclamide + rosiglitazone treatment group who have FPG < 270mg/dL after the glibenclamide 5mg om run-in will receive glibenclamide 5mg om + rosiglitazone 4mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of < 7%. If the HbA1c is > 7%, the dose of glibenclamide will be escalated in a similar fashion as above. The only exception is at visit 5 when the dose of rosiglitazone is increased (see next paragraph). Once the target HbA1c level of < 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is > 7% for 2 subsequent visits, the patient will be withdrawn from the study.
16245154|NCT01045577|Drug|Masitinib|6 mg/kg/day
16245155|NCT01045577|Drug|Masitinib|3 mg/kg/day
16245156|NCT01045577|Drug|Placebo|Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)
16245157|NCT01045564|Biological|GSK influenza virus H5N1 vaccine 1557484A|Three doses of GSK 1557484A administered intramuscularly (IM), the first and third in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm
16245158|NCT01045551|Drug|Apremilast|20mg taken orally twice per day for 12 weeks
16245159|NCT01045538|Drug|Vorinostat, capecitabine, and cisplatin|Vorinostat 200~400mg per day on day1-day14 combined with capecitabine 800-1,000mg/m2/dose, BID on day1-day14, and cisplatin 60-80mg/m2 on day 1
16245160|NCT01045525|Procedure|Phlebotomy|From 300 to 400mL for women; From 350 to 450mL for men
16245161|NCT01045525|Behavioral|Lifestyle and diet advices|2 Booklets with Dietary and physical activity advices
16245162|NCT01045512|Drug|fluvastatin|40-80mg once daily
16245163|NCT01045499|Device|Laparoscopic adjustable gastric banding (Allergan Lap Band)|Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
16245164|NCT01045486|Drug|ATP mixed probiotics|- Patients in Group A will receive ATP mixed probiotics for 6 weeks. And after 4 weeks wash-out period, they will receive placebo for 6 weeks
16245165|NCT01045486|Drug|Placebo|- Patients in Group B will receive placebo for 6 weeks. And after 4 weeks wash-out period, they will receive ATP mixed probiotics for 6 weeks
16245166|NCT01045460|Biological|Activated marrow infiltrating lymphocytes|Administered on Days 3 and 4.
16245167|NCT01045460|Biological|Allogeneic Myeloma Vaccine|Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.
16245168|NCT01045460|Drug|Cyclophosphamide|Administered at 2.5 g/m^2.
16245169|NCT01045460|Biological|Filgrastim|Administered post cyclophosphamide daily until leukapheresis.
16245170|NCT01045460|Procedure|Leukapheresis|Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.
16245171|NCT01045460|Drug|Melphalan|100 mg/m^2/day given on Days -2 and -1.
16245172|NCT01045460|Biological|Autologous stem cell transplant|Infused on Day 0.
16245173|NCT01045447|Drug|insulin degludec/insulin aspart|Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
16245174|NCT01045447|Drug|insulin glargine|Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16245175|NCT01045434|Drug|Omeprazole|Omeprazole Magnesium DR 20 mg Capsules
16245176|NCT01045421|Drug|MLN8237 (Alisertib)|"Phase 1:
~MLN8237 will be administered orally twice a day on a 7-day dosing schedule
~Phase 2:
~MLN8237 will be administered orally at the maximum tolerated dose determined in Phase 1 for 7-days followed by a minimum 14-day rest period."
16245177|NCT01045408|Dietary Supplement|Berry extract|Berry extract for weeks
16245178|NCT01045395|Dietary Supplement|Corn starch|90mg/d
16245179|NCT01045395|Dietary Supplement|Unique Marine Algae Concentrate (UMAC)|90mg/d
16245180|NCT01045395|Dietary Supplement|Golden brown algae|90mg/d
16245181|NCT01045382|Biological|Mesenchymal stem cells|Mesenchymal stem cell injection
16245182|NCT01045382|Other|Isotonic solution|Isotonic solution injection
16245183|NCT01045369|Drug|Kaletra and Intelence Tablets|Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.
16245184|NCT01045343|Other|Integrated diagnositic system|Heart failure will be managed using the integrated diagnostic system which consists of patient tools and a new Heart Failure Clinician's website which displays a new Heart Failure Risk score. This Heart Failure Clinician's website will be reviewed every 2 weeks in addition to scheduled in-office visits every three months.
16245185|NCT01045343|Other|Routine in office visits|Heart failure will be managed with scheduled in-office visits every three months.
16245186|NCT01045330|Behavioral|a modified NTU-HELP|The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
16245187|NCT01045317|Drug|PF-04776548|single intravenous or oral administration of 0.1mg PF-04776548.
16245188|NCT01045304|Drug|Iniparib|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16245189|NCT01045304|Drug|Gemcitabine|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16245190|NCT01045304|Drug|Carboplatin|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16245230|NCT01044927|Other|Standard Therapy|No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.
16245192|NCT01045278|Drug|Pegylated interferon-alfa-2b and ribavirin|Pegylated interferon-alfa-2b 1.5 microg/kg subcutaneously once weekly plus weight based ribavirin 800-1200 mg PO for a variable period depending on their HCV genotype and response to treatment.
16245193|NCT01045265|Other|Seminal plasma pharmacokinetics|Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
16245194|NCT01045239|Device|Micropulse 577 nm yellow diode laser|Laser administered at beginning of study and may be repeated at 16 weeks if needed
16245195|NCT01045239|Device|532 nm green diode laser|Laser administered at beginning of study and may be repeated at 16 weeks if needed
16245196|NCT01045226|Procedure|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy
16245197|NCT01045226|Other|Quality-of-Life assessment|Quality of Life Assessment
16245198|NCT01045226|Other|Questionnaire Administration|Questionnaire Administration
16245199|NCT01045213|Other|Integrated Care|Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.
16245200|NCT01045200|Other|Comparison of follow-up|Comparison of follow-up by nurse or surgeon after rectal cancer surgery
16245201|NCT01045187|Radiation|brachytherapy|Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.
16245202|NCT01045187|Radiation|Xoft Axxent Electronic Brachytherapy System|21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
16245203|NCT01045174|Device|Nebulizer (breath-actuated versus conventional continuous-output)|Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.
16245204|NCT01045161|Drug|Aclidinium bromide|Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.
16245205|NCT01045161|Drug|Placebo|Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment
16245206|NCT01045148|Radiation|CyberKnife Radiosurgery|High Dose 3800 cGy/4 fractions
16245207|NCT01045148|Radiation|CyberKnife Radiosurgery|Moderate Dose 3400 cGy/5 fractions
16245208|NCT01045122|Drug|Propofol|For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained.
16245209|NCT01045122|Drug|Dexmedetomidine|For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr.
16245210|NCT01045109|Dietary Supplement|cholecalciferol|4,000 I.U. softgel daily orally for 48 weeks
16245211|NCT01045109|Dietary Supplement|cholecalciferol|cholecalciferol or vitamin D3 4,000 IU daily for 48 weeks
16245212|NCT01045096|Drug|Dexlansoprazole|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
16245213|NCT01045096|Drug|Dexlansoprazole|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
16245214|NCT01045096|Drug|Dexlansoprazole|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
16245215|NCT01045083|Drug|RO4917523|Oral single dose
16245216|NCT01045083|Drug|escitalopram|Oral single dose
16245217|NCT01045083|Drug|methylphenidate|Oral single dose
16245218|NCT01045083|Drug|placebo|Oral single dose
16245219|NCT01045057|Device|Puncture Set and Flexible Protector|The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.
16245220|NCT01045018|Drug|Placebo|placebo 400 mg
16245221|NCT01045018|Drug|Mesalamine|
16245222|NCT01045018|Drug|Mesalamine|
16245223|NCT01045005|Other|Administration ofOxygen and carbon dioxide|Inhalation of 100% oxygen and 4% carbon dioxide. This is non-harmful/non-toxic and will be given according to protocol previously described in the literature. It will be administered for a maximum of 4 minutes.
16245224|NCT01045005|Other|Administration of Oxygen and carbon dioxide|Inhalation of 100% oxygen and 4% carbon dioxide. This is non-harmful/non-toxic and will be given according to protocol previously described in the literature. It will be administered for a maximum of 4 minutes.
16245225|NCT01044992|Radiation|H215O PET|H215O PET investigations will be performed during two pharmacological conditions: OFF (e.g after 12 hours of usual dopaminergic treatment discontinuation) and ON (after an acute oral levodopa challenge) in all subjects. During each PET there will be two motor conditions: rest (no movement, hand and wrist lying on the joystick) and a right-hand movement, consisting of moving joystick in 4 four different directions avoiding sequence repetition performed at rest and during a right hand movement.
16245226|NCT01044992|Drug|Levodopa|Levodopa: the dosage of levodopa challenge will be equivalent to the first morning dose increased by 100 mg of levodopa whereas the dosage will be 200 mg in healthy subjects.
16245227|NCT01044966|Drug|ITV DepoCyt + Temozolomide|Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous oral dosing), followed by 7 days off in a 28 day cycle as a once daily dosing regimen.
16245228|NCT01044953|Other|shortened winter break|winter break shortened by 3 weeks (from 6.5 to 3.5) within the German Professional Soccer League in season 2009/2010
16245229|NCT01044927|Other|Integrated Care|Comparison of the effect of COPD education, self-management instruction, home monitoring with a Health Buddy Telemonitor, pulse oximeter, pedometer and spirometer, and enhanced communication with a study coordinator (cell phone access)
16245231|NCT01044901|Procedure|MRI, Transthoracic Echocardiography, tonometry, EKG|Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
16245232|NCT01044888|Drug|Heparin|150 U/kg heparin was administered intravenously at the beginning of graft anastomosis and accepted a perioperative ACT value of around 300 s. Ten minutes after the loading dose, the ACT was measured. An ACT of 300 s or greater was considered as adequate. Then follow up ACT measurement was determined after 30 min from the previous ACT measurement. If ACT fell below the target value of 300 s, an additional dose of heparin was administered. If ACT was between 250 and 299 s, additional 2000 U of heparin was administered and if ACT was between 200 and 249 s then additional 3000 U of heparin was injected. Ten minutes after additional heparin injection, ACT was remeasured.
16245233|NCT01044875|Procedure|Pan retinal photocoagulation laser treatment|Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
16245234|NCT01044862|Drug|Letrozole (aromatase inhibitor)|A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
16245235|NCT01044862|Drug|Clomiphene Citrate|CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
16245236|NCT01044862|Drug|Follicle Stimulating Hormone (gonadotropin)|A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
16245237|NCT01044836|Biological|HD203|Injectable form
16245238|NCT01044823|Other|3D and thermal imaging|subjects will be imaged before and after receiving DMARD therapy
16245239|NCT01044810|Drug|Efavirenz-based regimens|Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
16245240|NCT01044771|Drug|change from tenofovir to raltegravir|Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
16245241|NCT01044758|Drug|Levetiracetam 62.5mg|62.5mg twice daily (2 weeks)
16245242|NCT01044758|Drug|Levetiracetam 125mg|125mg twice daily (2 weeks)
16245243|NCT01044758|Drug|Levetiracetam 250mg|250mg twice daily (2 weeks)
16245244|NCT01044758|Drug|Placebo|placebo capsule twice daily (2 weeks)
16245245|NCT01044745|Drug|rituximab|Given IV
16245246|NCT01044745|Drug|mycophenolate mofetil|Given IV or PO
16245247|NCT01044745|Drug|tacrolimus|Given IV
16245248|NCT01044745|Drug|anti-thymocyte globulin|Given IV
16245249|NCT01044745|Procedure|allogeneic hematopoietic stem cell transplantation|Stem cell transplant
16245250|NCT01044745|Other|laboratory biomarker analysis|Correlative studies
16245251|NCT01044745|Biological|graft versus host disease prophylaxis/therapy|Undergo graft versus host disease prophylaxis/therapy
16245252|NCT01044745|Drug|cyclophosphamide|Given PO or IV
16245253|NCT01044745|Drug|fludarabine phosphate|Given IV
16245254|NCT01044745|Drug|busulfan|Given IV
16245255|NCT01044745|Radiation|total-body irradiation|Undergo TBI
16245256|NCT01044745|Biological|graft-versus-tumor induction therapy|Undergo graft-versus-tumor induction therapy
16245257|NCT01044745|Biological|immunosuppressive therapy|Undergo immunosuppressive therapy
16245258|NCT01044732|Device|Third Eye Retroscope|Device used with colonoscope to provide second, retrograde view of the colon
16245259|NCT01044719|Drug|Ceftazidime|Ceftazidime 2g TDS IV
16245260|NCT01044719|Drug|Tobramycin|Tobramycin 7mg/kg/day OD IV
16245261|NCT01044719|Drug|Meropenem|Meropenem 2g TDS IV
16245262|NCT01044706|Drug|Bicalutamide|50 mg Oral Tablet
16245263|NCT01044693|Drug|Placebo|Placebo capsule
16245264|NCT01044693|Drug|Nebivolol 5 mg|Nebivolol 5mg single oral dose
16245265|NCT01044693|Drug|metoprolol tartrate 50 mg|metoprolol tartrate 50 mg single oral dose
16245266|NCT01044693|Drug|Sildenafil25 mg|Sildenafil 25 mg single oral dose
16245267|NCT01044680|Dietary Supplement|NUTRIOSE|17 grams of NUTRIOSE consumed twice daily for 12 weeks
16245268|NCT01044680|Dietary Supplement|Placebo|17 g maltodextrin consumed twice daily for 12 weeks
16245269|NCT01044667|Behavioral|GI and Quality of Life Assessment|
16245270|NCT01044654|Genetic|SB-728-T|Each infusion will be 5-30 billion ZFN modified CD4+ T-cells
16245271|NCT01044628|Device|Concentrator|Patients allocated to the study group will receive oxygen overnight from an electrically-powered oxygen concentrator (NewLife Intensity Oxygen Concentrator, AirSep Corporation, Buffalo, NY, USA), to allow the oxygen saturation to be >90%
16245272|NCT01044628|Device|Sham concentrator|Patients allocated to the control group will receive ambient air delivered overnight through an electrically-powered oxygen concentrator (NewLife Intensity Oxygen Concentrator, Airsep Corporation, Buffalo, NY, USA) rendered ineffective by bypassing the sieve beds. The ineffective concentrators will have the same external appearance as the effective ones, allowing the trial to be double-blinded. We have requested approval by Health Canada in order to proceed with the modifications on the oxygen concentrators. Written permission is pending.
16245273|NCT01044602|Other|Laboratory evaluations, sleep study|Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
16245274|NCT01044602|Other|Best Medical Management|Standard of care.
16245275|NCT01044602|Procedure|Roux-en-Y gastric bypass surgery|Surgical treatment.
16245276|NCT01044589|Device|Biodesign Tissue Repair Graft|Biodesign Tissue Repair Graft reinforcement
16245277|NCT01044589|Other|Overlapping Sphincter Repair|Overlapping Sphincter Repair Alone
16245278|NCT01044563|Behavioral|Breathing training|Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
16245279|NCT01044563|Behavioral|Stress management|Cognitive reconstructive strategies for stress management
16245280|NCT01044550|Procedure|Laparoscopy|Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
16245281|NCT01044550|Other|Clinical follow up|Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.
16245282|NCT01044537|Drug|Placebo|Placebo to match PF-04937319 will be provided.
16245283|NCT01044537|Drug|PF-04937319|The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.
16245284|NCT01044524|Radiation|SLV 334|2000 mg via i.v. solution
16245285|NCT01044511|Behavioral|Home visits|home visits by specialist nurse 2 times and 1 phonecall
16245286|NCT01044511|Behavioral|standard|hotline
16245287|NCT01044498|Drug|Tocilizumab|Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2.
16245288|NCT01044498|Drug|Ortho-Novum® 1/35|Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
16245289|NCT01044485|Drug|lapatinib|escalation dose from 1250 to 1500 mg in association with docetaxel
16245290|NCT01044485|Drug|docetaxel|escalation dose from 75 mg/m2 to 100 mg/m2 in association with lapatinib
16245291|NCT01044459|Drug|Aclidinium Bromide 200 µg|aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
16245292|NCT01044459|Drug|Aclidinium Bromide 400 µg|aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
16245293|NCT01044446|Drug|Icodextrin|one exchange daily
16245294|NCT01044446|Drug|glucose-based peritoneal dialysate|original exchange frequency
16245295|NCT01044433|Drug|lapatinib ditosylate|Given orally
16245296|NCT01044433|Drug|capecitabine|Given orally
16245297|NCT01044420|Drug|mFOLFIRI|mFOLFIRI irinotecan 130-150mg/m2 iv d1 LV 200 mg/m2 iv 2h d1 5-FU 400 mg/m2 IV d1 5-FU 2.4-3 g/m2 CI 46-h repeat every 2 weeks
16245298|NCT01044407|Device|Pacemaker manipulation|Alternation of cardiac output by modulation of heart rate, atrioventricular delay and modulation from biventricular pacing to right ventricular pacing (where applicable)via a cardiac pacemaker
16245299|NCT01044394|Drug|polyethylene glycol (PEG-ELS) and bisacodyl tablets|2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy
16245300|NCT01044381|Drug|Luliconazole Solution, 10%|28 days of daily application
16245301|NCT01044368|Other|Internet Intervention|The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
16245302|NCT01044355|Device|CPAP|6 weeks treatment with fixed CPAP
16245303|NCT01044355|Device|APAP|6 weeks of treatment with auto-titrating positive airway pressure
16245304|NCT01044342|Drug|AZD1446|capsule; single oral dose
16245305|NCT01044342|Drug|AZD1446|capsule, single oral dose
16245306|NCT01044342|Drug|donepezil|capsule, single oral dose
16245307|NCT01044342|Drug|Placebo|capsule, single oral dose
16245308|NCT01044329|Drug|Bevacizumab|Intravitreal, 1.25 mg, 3 times, one month apart.
16245309|NCT01044329|Drug|Triamcinolone Acetonide|Intravitreal, 2 mg, 2 times, two months apart.
16245310|NCT01044316|Biological|Haemophilus influenzae type b (Hib) vaccine|Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.
16245311|NCT01044303|Drug|Myfortic Escalation|Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.
16245312|NCT01044290|Other|Life Completion|Subjects discussed life review, issues of forgiveness and heritage and legacy.
16245313|NCT01044290|Other|Attention Control|Subjects listened to a non-guided relaxation CD
16245314|NCT01044277|Drug|Glutathione supplementation|500 mg, two times daily
16245315|NCT01044277|Drug|Gluthathione peroxidases|125 mg, two times daily
16245316|NCT01044277|Other|Placebo|2 times daily
16245317|NCT01044264|Drug|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|Topical Gel
16245318|NCT01044264|Drug|Placebo|Placebo
16245319|NCT01044251|Drug|Frovatriptan|2.5 mg po bid for 10 days
16245320|NCT01044251|Drug|Placebo|1 tab po bid for 10 days
16245321|NCT01044238|Drug|methylphenidate|18mg/day in week 1; 36mg/day in week 2; 54mg/day in week 3 - participants randomized to either active medication (methylphenidate) or placebo matched to active drug
16245322|NCT01044238|Drug|Methylphenidate|18mg/day for week 1; 36mg/day for week 2; 54mg/day for remainder of study - participants randomized to either active medication (methylphenidate) or placebo
16245323|NCT01044225|Drug|Cetuximab|An initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour.
16245324|NCT01044225|Drug|Cilengitide EMD 121974|A dose of 2000 mg by IV administration 2 weekly.
16245325|NCT01044212|Drug|Docusate|Docusate 100mg BID
16245326|NCT01044212|Drug|Bowel medications|Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
16245327|NCT01044199|Biological|PCEC rabies vaccine given intradermally|PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
16245328|NCT01044199|Biological|PCEC rabies vaccine administered intramuscularly|PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
16245329|NCT01044186|Drug|ICL670|
16245330|NCT01044173|Device|MR scan|axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold
16245331|NCT01044147|Behavioral|VLM-S|Online program for weight loss - standard
16245332|NCT01044147|Behavioral|VLM-M|Online program for weight loss - modulated
16245333|NCT01044147|Behavioral|OGR|Online program for weight loss - resources
16245334|NCT01044134|Behavioral|Dietary counseling|Participants will receive personalized dietary counseling to promote behavior change
16245335|NCT01044121|Other|Mattress Firmness|Current mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device.
16245336|NCT01044108|Drug|NNC 0070-0002-0453|Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
16245337|NCT01044108|Drug|'2-0453|Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
16245338|NCT01044108|Drug|placebo|Placebo will be administered as a comparator at each dose level.
16245339|NCT01044095|Biological|FluMist® live, attenuated, intranasal seasonal influenza vaccine|FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
16245340|NCT01044095|Biological|Fluzone® inactivated influenza virus vaccine|Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
16245341|NCT01044082|Procedure|controlled cord traction|In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs
16245342|NCT01044082|Procedure|Clinical signs of placental separation|Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure
16245343|NCT01044069|Biological|gene-modified T cells targeted|Pts will undergo leukapheresis. The leukapheresis product will be washed & frozen until the GTF is directed to start T cell production by the PI. CD3+ T cells will be isolated from the leukapheresis, & transduced with the 19-28z chimeric receptor & expanded. All relapsed (either MRD+ or morphologic) & refractory pts get re-induction chemo whenever feasible to optimally reduce the tumor burden prior to the T cell infusion. The re-induction chemo regimen will be selected by the treating dr. based on prior therapy, adverse reactions to chemo & highest likelihood to achieve an optimal response. Once pts recover from the toxicities of the re-induction chemo the disease status will be re-evaluated by repeating bone marrow aspirate or biopsy. Pts get conditioning chemo (min 2 weeks from end of re-induction chemo) followed 2-7 days later by the 19-28z+ T cells. Pts will be tx in 2 cohorts with diff doses of T cells according to the amount of disease immediately prior to the T cell infusion.
16245344|NCT01044056|Drug|Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets|LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
16245345|NCT01044056|Drug|norelgestrominum and ethinylestradiol patch oral contraceptive patch|A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
16245346|NCT01044056|Drug|Nuvaring ™ (etonorgestrel/ethinylestradiol)|NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
16245347|NCT01044043|Procedure|clinical examination and quality of life questionnaire|clinical examination and quality of life questionnaire
16245348|NCT01044030|Drug|Xylitol syrup|7.5 mL (5 grams) by mouth three times daily
16245349|NCT01044030|Drug|Placebo|7.5 mL by mouth three times daily
16245350|NCT01044017|Drug|Placebo|single oral dose
16245351|NCT01044017|Drug|RO4998452|single oral doses
16245352|NCT01044004|Drug|Armodafinil|Armodafinil 150 mg/day for 13 weeks
16245353|NCT01044004|Drug|placebo|Placebo 150mg/day for 13 weeks
16245354|NCT01044004|Drug|Armodafinil|Armodafinil 150 mg/day for 13 weeks
16245355|NCT01044004|Drug|placebo|Placebo 150mg/day for 13 weeks
16245356|NCT01043991|Drug|Darbepoetin alfa|
16245357|NCT01043991|Drug|Placebo|
16245358|NCT01043978|Behavioral|Use of baby bottle nipple|Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle
16245359|NCT01043965|Drug|Metformin|Metformin 850mg
16245360|NCT01043952|Drug|Propofol|Propofol is used as an anesthetic drug on all patients, with the dosing depending on patient age, weight, body mass index, general status, the hemodynamic and neurophysiological response to the previously administered dose and the degree of surgical stimulation, and in the Bispectral Index Monitor arm, depending on the BIS values.
16245361|NCT01043952|Drug|Remifentanil|Remifentanil is used as analgesic drug, as a part of the total intravenous anaesthesia, on all patients, with the dosing depending on patient age, weight, body mass index, general status, the hemodynamic and neurophysiological response to the previously administered dose and the degree of surgical stimulation, and in the Bispectral Index Monitor arm, depending on the BIS values.
16245362|NCT01043952|Device|Bispectral Index Monitor|Bispectral Index Monitor (BIS monitor integrated in the IntelliVue Patient monitor MP70, Philips) is used to monitor the depth of anesthesia. The values this monitor reports are used as an aid in evaluating the response of the single patient to the administered anesthetics, and as a guide in adjusting the dosing of anesthetics. We follow the algorithm from: http://www.biseducation.com/assets.aspx?ac=1 (ASA Practice Advisory White Paper)
16245363|NCT01043939|Other|Purple Grape Juice|6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
16245364|NCT01043939|Other|Apple Juice|6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
16245365|NCT01043926|Drug|Suvorexant|single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.
16245366|NCT01043913|Drug|Guarana extract|Guarana extract 50mg q12 hours for 21 days
16245367|NCT01043900|Procedure|repetitive transcranial magnetic stimulation (rTMS)|30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex
16245368|NCT01043887|Drug|ridaforolimus|single oral dose administration 10 mg ridaforolimus
16245369|NCT01043874|Drug|Nilotinib|400 mg BID
16245370|NCT01043848|Procedure|external electric pudendal nerve stimulation|"intervention timing: twice daily for 20 minutes during 3 consecutive months.
~intervention procedure: electrodes will be placed around the penile shaft (in males) or clips will be directly placed on the clitoris (in females).
~intervention device: contic+
~stimulation parameters: 10 Hz, 200μs pulse width, 10mA (or less, if too uncomfortable)."
16245620|NCT01042041|Drug|cisplatin|Given via transarterial/hepatic chemoembolization
16245371|NCT01043835|Procedure|Laparoscopy-assisted gastrectomy|A 10-mm trocar for laparoscope was inserted below the umbilicus. Another 10-mm trocar was introduced in the left preaxillary line 2 cm below the costal margin as a major hand port，and a 5-mm trocar was placed at the contralateral site for traction. A 5-mm trocar was inserted in the left midclavicular line 2 cm above the umbilicus as an accessory port, and a 15-mm trocar also as an accessory port was placed at the contralateral site. The operator stood on the left side of the patient. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction. Dissected stomach and lymph node are collected through additional 5 cm incision at a median superior abdominal incision.
16245372|NCT01043835|Procedure|Open gastrectomy|Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction for all cases.
16245373|NCT01043809|Behavioral|Procter & Gamble school-based handwashing promotion program|Handwashing promotion lesson and materials targeting first grade students
16245374|NCT01043809|Behavioral|expanded school-based handwashing promotion|Procter & Gamble's standard school-based handwashing promotion education and materials targeting first grade students, plus a program enhancement. In China, enhancement consists of a supply of soap for school sinks. In Pakistan, enhancement consists of soap for school sinks, plus enlistment of a peer hygiene champion in each first grade class. In the Philippines, enhancement consists of enlistment of a peer hygiene champion in each first grade class.
16245375|NCT01043796|Other|Insecticide treated nets and wall liners|Participants will be provided a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme. Households where participants reside will be fitted with insecticide treated wall liners.
16245376|NCT01043796|Other|Insecticide treated nets alone|Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme
16245377|NCT01043783|Other|Dietary Adherence|Subjects consumed a specified healthy, balanced, reduced calorie diet and provided timed breath samples.
16245378|NCT01043770|Behavioral|Group lifestyle education|Structured group education programme based on lifestyle changes (dietary and increased physical activity)
16245379|NCT01043757|Behavioral|Financial incentives for increasing physical exercise|Throughout the 12-week intervention, participants will receive step goals. The step goals will increase by 250 steps per week, The intervention will last a total of 12 weeks. After each seven-day week, step goals will increase by an additional 250 steps - thus over the 12 weeks, participants will be asked to increase their daily step count by 3,000. Participants will receive financial incentives to attain these step goals; the incentive schemes differ according to intervention arm.
16245380|NCT01043744|Drug|Artemether-Lumefantrine|"Artemether-lumefantrine (Coartem; Novartis) administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of:
~1 tablet (for patients weighing 5-14 kg)
~2 tablets (for patients weighing 15-24 kg)"
16245381|NCT01043731|Procedure|Laparoscopic transvaginal hybrid anterior resection|Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.
16245382|NCT01043718|Behavioral|More-Intensive|The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.
16245383|NCT01043718|Behavioral|Less-Intensive|The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.
16245384|NCT01043692|Other|Acupuncture|Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly
16245385|NCT01043679|Drug|Utapine|Efficacy and Safety of Utapine
16245386|NCT01043679|Drug|Seroquel|Efficacy and Safety of Seroquel
16245387|NCT01043666|Drug|YM178|oral
16245388|NCT01043666|Drug|Placebo|oral
16245389|NCT01043666|Drug|tolterodine ER|oral
16245390|NCT01043640|Drug|Campath-1H|Administered Days -21, -20 and -19, 0.3 mg/kg subcutaneously (SQ) or intravenously (IV)
16245391|NCT01043640|Drug|Cyclophosphamide|Administered days -10 through -6, 50 mg/kg/day intravenous (IV) over 2 hours - with Mesna continuous infusion or 5 times daily.
16245392|NCT01043640|Drug|Busulfan|Administered every 6 hours: If < or = 12 kg then 1.1 mg/kg/dose intravenous (IV). If > 12 kg then 0.8 mg/kg/dose IV
16245393|NCT01043640|Procedure|Allogeneic stem cell transplantation|Administered > 24 hours after last dose of busulfan.
16245394|NCT01043640|Drug|Cyclosporine A|"2.5 mg/kg/dose intravenous (IV_ beginning on day -3. Frequency of daily dosing will be based on the recipient's body weight:
~If body weight is ≤ 40 kg dosing will be 3 times daily
~If body weight is > 40 kg dosing will be 2 times daily An attempt will be made to maintain a trough cyclosporine level of 250 mg/L to 350 mg/L. Once the patient can tolerate oral medications and has a normal gastrointestinal transit time, CsA will be converted to an oral form at a dose 2 times the current IV dose (maximum 12.5 mg/kg/day as initial oral dose)."
16245429|NCT01043354|Behavioral|stage-matched intervention|6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
16245665|NCT01041781|Other|placebo|Given orally
16245395|NCT01043640|Drug|Mycophenolate Mofetil|15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight: The same dosage is used orally or intravenously. Stop MMF at day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later.
16245396|NCT01043614|Behavioral|PEER group intervention|An exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year
16245397|NCT01043601|Drug|Inhaled PT005|inhaled, twice daily for 1 week duration
16245398|NCT01043601|Drug|Inhaled Placebo|inhaled, twice daily for 1 week duration
16245399|NCT01043601|Drug|Formoterol Fumarate 12 µg (Foradil Aerolizer)|inhaled, twice daily for 1 week duration
16245400|NCT01043588|Procedure|TURP|TransUrethral Resection of the Prostate
16245401|NCT01043588|Procedure|PVP|Photo selective Vaporization of the Prostate
16245402|NCT01043575|Drug|Rifapentine|During the first 8 weeks of therapy for TB participants > 45 kg will receive rifapentine 600 mg orally given 5 per week and for participants < 45 kg participants will receive 450 mg orally given 5 days per week
16245403|NCT01043575|Drug|Rifampin|During the first 8 weeks of therapy participants will receive rifampin at standard doses (e.g. 600 mg) 5 days per week
16245404|NCT01043562|Diagnostic Test|Defibrillator threshold testing|Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricular fibrillation (VF) for all subjects, with a 3-5 minute observation/waiting period between inductions. The initial shock energy was programmed at 9 joules (J) for all patients, with internal rescue shocks at 31J followed by device-specific maximum deliverable energy. The outcome of the initial induction determined the programmed energies for both the initial and internal rescue shocks for the second induction, and likewise for the third induction. All shocks were biphasic and delivered at manufacturers' default tilt, polarity and duration, and all final programmed shock vectors included an active can. External defibrillation pads were in place for delivery of external rescue shock should the internal shocks fail.
16245405|NCT01043562|Other|Observation of post-shock intrinsic cardiac rhythm|Prior to each of the three ventricular fibrillation inductions performed as part of the binary search protocol, post-shock pacing was re-programmed using a pre-determined, stepwise protocol that progressively decreased the lower rate limit. For the purpose of this protocol, post-shock pacing was considered necessary if 1) ≥7 ventricular-paced beats or 2) asystole >4 seconds was observed in the first 20 seconds after defibrillation, or if the systolic blood pressure demonstrated a >10% decrease from pre-induction baseline at follow-up measurement 1 minute post-defibrillation. Rescue ventricular pacing via the programmer was available for all subjects.
16245406|NCT01043549|Device|rTMS|Repetitive transcranial stimulation of the posterior parietal cortex
16245407|NCT01043549|Device|Sham rTMS|Repetitive transcranial stimulation of the posterior parietal cortex
16245408|NCT01043536|Radiation|radiotherapy|patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
16245409|NCT01043536|Drug|temozolomide|patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.
16245410|NCT01043523|Drug|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
16245411|NCT01043510|Drug|insulin degludec|0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
16245412|NCT01043510|Drug|insulin detemir|0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
16245413|NCT01043484|Drug|Bevacizumab + Capecitabine + Radiotherapy|Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)
16245414|NCT01043484|Drug|Capecitabine + Radiotherapy|Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)
16245415|NCT01043471|Other|Chewing gum|Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.
16245416|NCT01043471|Other|Water|Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.
16245417|NCT01043458|Drug|ABT-126|ABT-126 Low Dose & ABT-126 High Dose
16245418|NCT01043458|Drug|Placebo for ABT-126|Matching Placebo for Arms 1 & 2
16245419|NCT01043445|Dietary Supplement|GPR 119 agonist, 2-oleyl glycerol|Emulgation, 50 ml. containing 2g 2OG
16245420|NCT01043445|Dietary Supplement|Oleic acid|Emulgation, 50 ml. containing 1.54g of oleic acid
16245421|NCT01043445|Dietary Supplement|Vehicle|Fifty milliliters of glycerol (Sigma-Aldrich; batch 32296AK, purity 99%) plus 5 ml 96% ethanol
16245422|NCT01043419|Drug|xenon|Inhalational gas; dose allowed max.70 Vol.% in 30 % oxygen; the duration of the treatment will be to 30 minutes
16245423|NCT01043406|Device|Seizure Advisory System|Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.
16245424|NCT01043393|Drug|Desoximetasone 0.25% spray|Desoximetasone spray applied to affected areas twice daily for 28 days
16245425|NCT01043380|Drug|Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]|Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.
16245426|NCT01043380|Drug|Lipitor (Atorvastatin) monotherapy|The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.
16245427|NCT01043367|Dietary Supplement|Deprexil|One 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.
16245428|NCT01043367|Dietary Supplement|Placebo|One Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.
16245621|NCT01042041|Drug|mitomycin C|Given via transarterial/hepatic chemoembolization
16245431|NCT01043354|Behavioral|attention placebo intervention|6 monthly counseling sessions about general health topics
16245432|NCT01043341|Behavioral|educative folder|folder about HPV infection and vaccines
16245433|NCT01043289|Other|Light therapy|During the 5-week treatment period, subjects sit in front of a light box for 60 minutes daily after awakening, at a specified distance that provides the required light intensity.
16245434|NCT01043276|Drug|Treatment A|PF-00258210 220 µg using inhaler A
16245435|NCT01043276|Drug|Treatment B|PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A
16245436|NCT01043276|Drug|Treatment C|PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A
16245437|NCT01043276|Drug|Treatment D|PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A
16245438|NCT01043276|Drug|Treatment E|PF-00258210 220 µg using inhaler B
16245439|NCT01043263|Drug|EN3324 (axomadol)|twice daily dosing
16245440|NCT01043263|Drug|Placebo|twice daily dosing
16245441|NCT01043224|Drug|Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle|Once daily application
16245442|NCT01043211|Drug|Lidocaine Hydrochoride Injection, without epinephrine|A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. Immediately thereafter, lidocaine (1%, 10 mg/ml) will be administered on a standardized 0.3 ml/hr/kg (3 mg/kg/hr, maximum 200 mg/hr = 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the lidocaine infusion will be decreased by 50% to 0.15 ml/hr/kg (1.5 mg/kg/hr, maximum 100 mg/hr = 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
16245443|NCT01043211|Drug|Normal Saline|A standardized 0.2 ml/kg intravenous bolus dose of preservative-free normal saline will be given after anesthetic induction but prior to skin incision. Immediately thereafter, normal saline will be administered on an equal 0.3 ml/hr/kg (maximum 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the normal saline infusion will be decreased by 50% to 0.15 ml/hr/kg (maximum 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
16245444|NCT01043211|Drug|Normal Saline|A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision.
16245445|NCT01043198|Genetic|Clinical examination and blood sampling for biological and genetic analysis|"Clinical examination and precise description of the phenotype (questionnaire)
~Standardized screening with :
~radiological (hands, feet, spine ; and renal ultrasonography)
~biological (hormonal, metabolic, and basic genetic investigations (karyotype, FISH 22q11.2, Fragile X, and other depending on the clinical data))"
16245446|NCT01043185|Drug|AZD3355|30 mg orally in the morning and 30 mg in the evening for 1 day
16245447|NCT01043185|Drug|AZD3355|90 mg orally in the morning and 90 mg in the evening for 1 day
16245448|NCT01043185|Drug|AZD3355|120 mg orally in the morning and 120 mg in the evening for 1 day
16245449|NCT01043185|Drug|AZD3355|240 mg orally in the morning and 240 mg in the evening for 1 day
16245450|NCT01043185|Drug|placebo|Placebo capsules orally in the morning and placebo capsules in the evening for 1 day
16245451|NCT01043172|Drug|Gemcitabine|Gemcitabine : 1000 mg/m2/day D1,8,15 Repeated every 4 weeks 6 cycles
16245452|NCT01043146|Drug|COR-1|single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
16245453|NCT01043146|Drug|placebo|intravenous 0.9 % NaCl
16245454|NCT01043133|Behavioral|social marketing-based medical education intervention|social-marketing based medical education intervention designed to influence medical student use of evidence-based templates. Led by physician instructor.
16245455|NCT01043120|Drug|Barusiban|IV bolus of 20 mg for 1 minute followed by an IV infusion of 19 mg for up to 59 minutes. The maximum total duration of administration was 60 minutes.
16245456|NCT01043120|Drug|Placebo|IV bolus of saline (sodium chloride 0.9%) for 1 minute followed by an IV infusion of saline (sodium chloride 0.9%) for up to 59 minutes. Details on injection volume, infusion rates and doses are tabulated below.
16245457|NCT01043094|Drug|Pitavastatin 4mg|Pitavastatin 4mg single dose
16245458|NCT01043068|Drug|Cancer pain management|Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.
16245459|NCT01043042|Other|No interventions will be used in this study|No interventions will be used in this study
16245460|NCT01043029|Drug|aleglitazar|Aleglitazar 150 mcg po daily for 52 weeks
16245461|NCT01043029|Drug|pioglitazone|Pioglitazone 45 mg po daily for 52 weeks
16245462|NCT01043016|Procedure|Photodynamic therapy|patient undergo Photocyanine Injection via venous infusion followed by photodynamic therapy with 670nm diobe laser 24 hours later
16245463|NCT01043003|Other|educational intervention|Undergo Bilingual Breast Cancer Educational Intervention
16245464|NCT01043003|Procedure|quality-of-life assessment|Ancillary studies
16245465|NCT01043003|Other|Questionnaire Administration|Ancillary studies
16245466|NCT01043003|Other|psychosocial support for caregiver|Support for caregiver
16245467|NCT01043003|Procedure|assessment of therapy complications|Ancillary study
16245468|NCT01043003|Other|informational intervention|Undergo evaluation sessions
16245469|NCT01042990|Other|Adaptive Physical Activity|Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
16245470|NCT01042977|Drug|Dapagliflozin|10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
16245471|NCT01042977|Drug|Placebo|matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
16245472|NCT01042964|Drug|revacept (PR-15)|single intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers.
16245473|NCT01042951|Biological|ShanChol Cholera Vaccine|55 adults (18-45 year old) will be given 2 doses of the bivalent whole-cell cholera vaccine 55 Toddlers(2-5 years) will be given 2 doses of the bivalent whole-cell cholera vaccine 55 Younger children(12-23 months)will be given 2 doses of the bivalent whole-cell cholera vaccine
16245474|NCT01042951|Other|Placebo|55 adults (18-45 year old) will be given 2 doses placebo, 55 Toddlers(2-5 years) will be given 2 doses of placebo, and 55 Younger children(12-23 months)will be given 2 doses of placebo
16245475|NCT01042938|Drug|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks)
16245476|NCT01042938|Drug|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks)
16245477|NCT01042925|Drug|XL147 (SAR245408)|administered orally once daily as tablet(s)
16245478|NCT01042925|Biological|trastuzumab|administered by IV once every 3 weeks
16245479|NCT01042925|Drug|paclitaxel|administered by IV once every week
16245480|NCT01042899|Behavioral|Teen Online Problem Solving (TOPS)|The TOPS program has 10 sessions that provide training in stress management, problem solving, communication, and social skills to all enrolled families, while the remaining 6 sessions address content related to the stressors and burdens of individual families. Each self-guided online session includes real adolescents talking about how TBI affected them, content regarding the skill, video clips showing adolescents and/or families modeling the skill, and exercises giving the family an opportunity to practice the skill. After the completion of the self-guided web pages, the family will meet with the therapist via videoconference; the therapist will review the exercises and help the family implement the problem-solving process with a problem or goal identified by the family.
16245481|NCT01042899|Behavioral|Teen Online Problem Solving--Teen Only (TOPS-TO)|TOPS-TO targets the same skills as TOPS and includes largely the same website and intervention content. However, it differs with respect to the extent of family involvement in the sessions. In TOPS-TO, sessions will be conducted with the child or adolescent alone, rather than with the family as whole. Parents will be given access to the TOPS-TO website content via their own password protected site so they will understand the skills that their child is learning. However, only the adolescent, and not the parents, will participate in the synchronous videoconferences with the therapist.
16245482|NCT01042899|Behavioral|Internet Resources Comparison (IRC)|Families in the IRC group will also receive a computer, printer, and high-speed internet access if they do not currently have these. Additionally, IRC families receive access to a home page of brain injury resources and links (identical to those given on the TOPS and TOPS-TO homepage) but will not be able to access specific session content. This will enable us to equate the groups with respect to access to the information and resources available on the Web.
16245483|NCT01042886|Behavioral|PILI 'Ohana Lifestyle Program|9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
16245484|NCT01042886|Behavioral|Standard Behavioral Weight Loss Maintenance Program|9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.
16245485|NCT01042873|Drug|3 hours intravenous dobutamine|Intravenous dobutamine will be infused during 3 hours. At the first and last 0.5 hors of infusion dose will be increased gradually, while in the middle 2 hours dose will remain constant.
16245486|NCT01042860|Dietary Supplement|Lutein|Lutein supplement, 10 mg daily
16245487|NCT01042860|Dietary Supplement|Placebo|Placebo
16245488|NCT01042834|Other|Air pollution study on healthy volunteers.|"The subjects are examined three times:
~First the volunteers get used to equipments.
~Second and third the volunteers sleep in a pollution or purified air."
16245489|NCT01042821|Procedure|partial rectal wall advancement flap|The flap comprised mucosa, submucosa and circular muscle fibers. It is raised from the dentate line and mobilized 4-6 cm cephaled and advanced to the new dendentate line (1 cm below the dentate line) and sutured with absorbable sutures (vicryl; ethicone 3/0). Also the defect is closed with absorbable sutures.
16245490|NCT01042821|Procedure|mucosal advancement flap|Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening
16245491|NCT01042795|Drug|Sunitinib|Sunitinib 37.5 mg daily X 16 weeks
16245492|NCT01042782|Drug|RAD001 and MitomycinC|"RAD001 tablets daily, 5mg, 7.5 mg or 10 mg (3 cohorts)
~Mitomycin C 5 mg/m2 i.v. every 3 weeks"
16245493|NCT01042769|Drug|Aleglitazar|aleglitazar 150 micrograms po daily
16245494|NCT01042769|Drug|Placebo|placebo control po daily
16245495|NCT01042743|Procedure|robot-assisted surgery|da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
16245496|NCT01042743|Procedure|laparoscopic right-hemicolectomy|Conventional laparoscopic procedures
16245497|NCT01042730|Drug|Pitavastatin 1 mg daily or 4 mg daily|Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.
16245498|NCT01042717|Drug|Plerixafor|Plerixafor administered at 16 hours prior to apheresis
16245499|NCT01042704|Drug|Bendamustine|Bendamustine is given intravenously (into a vein or IV infusion) on days 1 and 2 of each cycle. Each bendamustine infusion will take 60 minutes
16245500|NCT01042704|Drug|Lenalidomide|Lenalidomide is taken orally (by mouth) in the morning on days 1 through 21 of each cycle.
16245501|NCT01042704|Drug|Dexamethasone|Dexamethasone is taken orally (by mouth) on days 1, 8, 15, and 22 of each cycle.
16245502|NCT01042704|Drug|Aspirin|All patients will receive enteric coated aspirin, 325 mg, QD while on study. If patient is unable to tolerate aspirin, patient should receive other types of anti-coagulation like Coumadin or low molecular weight heparin.
16245503|NCT01042704|Drug|Prophylaxis|All patients will receive prophylaxis with either an H-2 blocker or proton pump inhibitor (PPI) while on study medications. Suggested medications included ranitidine 150 mg PC BID or omeprazole 20 mg PO QD or equivalent.
16245504|NCT01042704|Drug|Antibiotic|PCP antibiotic prophylaxis with a Bactrim will be recommended. In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.
16245505|NCT01042704|Other|Biweekly Follow Up|Vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured, and Blood tests to check CBC, Calcium, Electrolytes, serum, creatinine, and BUN. This follow up will take place at the Hillman Cancer Center, or whichever cancer center in which the subject is treated.
16245622|NCT01042041|Procedure|transarterial chemoembolization|
16245623|NCT01042041|Procedure|hepatic artery embolization|
16245506|NCT01042704|Other|Cyclical Follow Up|At the beginning of each treatment cycle subjects will undergo a Physical exam, a Performance status check, Recording of any new symptoms or side effects and any new medications, Blood tests (including blood chemistry, organ function and indicators of disease), Urine test, and pregnancy test (if applicable).
16245507|NCT01042704|Other|Restaging|Every other cycle subjects' disease will be restaged. This will be accomplished by their treatment physician. Re-staging procedures includes a regular office visit, x-ray, and a bone marrow biopsy. Subjects will spend approximately 4 hours at the Hillman Cancer Center or the UPMC Cancer Center location where they are being treated for this re-staging.
16245508|NCT01042704|Other|Post-Treatment Follow Up|"After subjects stop receiving the study drugs, they will be followed every 3 months for the first two years, every 6 months for years 2-5, and annually thereafter. The following procedures, which are considered routine for their cancer care, will be done as part of this follow-up:
~Physical exam
~Performance status (check of ability to perform daily functions)
~Recording of any new symptoms and any new medications being taken
~Blood tests to check blood counts (numbers of red and white blood cells and platelets), blood chemistry (to check organ function), and indicators of disease (immunoglobulins)
~Urine test (24hr urine)
~Women who are able to have children will have a pregnancy test (4 weeks after their last dose of lenalidomide).
~A check of the status of disease (includes bone marrow biopsy, skeletal survey, and blood and urine tests). Bone marrow biopsy will be done at the end of treatment, if subjects have a complete response, and their disease gets worse."
16245509|NCT01042691|Drug|Oxaliplatin|The starting dose of oxaliplatin administered via isolated hepatic perfusion will be the safe tolerated dose of intra-arterial infusion and pharmacokinetics from intravenous studies. The dose will be 5 mg/m2 and will be escalated.
16245510|NCT01042678|Biological|MP0112|Single intravitreal injection of MP0112 in the study eye
16245511|NCT01042665|Drug|latanoprost 0.005%|Active comparator
16245512|NCT01042665|Drug|Placebo|Placebo comparator
16245513|NCT01042652|Drug|Raltegravir|Raltegarvir 400mg bid
16245514|NCT01042639|Behavioral|passive physical activity|extension and flexion range-of-motion exercise against passive resistance of both the upper and lower extremities. Both extension and flexion were performed five times at the wrist, elbow, shoulder, ankle, knee, and hip joints
16245515|NCT01042626|Other|Oral peptones load|Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline
16245516|NCT01042613|Procedure|Cannulation using Accuvein device|If the research participant has been randomized to the AV300 device group A, then intravenous cannulation will be attempted using the AV300 device following manufacturer's instructions by four anesthesiologists.
16245517|NCT01042613|Procedure|Standard Cannulation method|If the research participant has been randomized to the standard treatment group B then cannulation will be attempted in the standard manner. A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.
16245518|NCT01042600|Device|Endotracheal tube insertion|Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)
16245519|NCT01042600|Device|Laryngeal mask airway insertion|Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
16245520|NCT01042587|Other|exposure to bright light|Elders will be engaged in an activity period which will focus their attention in the direction of bright light, thus ensuring viewing the light source for a daily exposure of thirty minutes.
16245521|NCT01042587|Other|low luminosity red light|Low level red light should not entrain circadian rhythm and will serve as a placebo control
16245522|NCT01042574|Drug|Clevidipine butyrate|Cleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG.
16245523|NCT01042561|Dietary Supplement|Vitamin D3|400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
16245524|NCT01042561|Dietary Supplement|vitamin D3 placebo|Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
16245525|NCT01042535|Biological|adenovirus-p53 transduced dendritic cell (DC) vaccine|Given intradermally (ID)
16245526|NCT01042535|Drug|1-methyl-d-tryptophan|Given orally (PO)
16245527|NCT01042535|Other|Laboratory biomarker analysis|Correlative studies
16245528|NCT01042522|Biological|Bleomycin Sulfate|Given IV
16245529|NCT01042522|Drug|Carboplatin|Given IV
16245530|NCT01042522|Drug|Cisplatin|Given IV
16245531|NCT01042522|Drug|Etoposide Phosphate|Given IV
16245532|NCT01042522|Other|Laboratory Biomarker Analysis|Correlative studies
16245533|NCT01042522|Drug|Paclitaxel|Given IV
16245534|NCT01042509|Drug|Alemtuzumab and rituximab|Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25
16245535|NCT01042496|Drug|Lamotrigine|12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.
16245536|NCT01042496|Procedure|1H-MR|Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).
16245537|NCT01042483|Device|LaborPro device|monitoring labor progression by using a new device The LaborPro system (Trig Medical Inc) allows determination of fetal head station and position using ultrasound and position tracking system.
16245538|NCT01042457|Drug|Mycophenolate mofetil|Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
16245539|NCT01042444|Device|GARDEX™|"GARDEX is an embolic protection system to contain and remove embolic material (thrombus/debris) during cardiovascular interventions.
~The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. The GARDEX Embolic Protection System may be used with commercially available 0.014 guide wires."
16245540|NCT01042431|Other|No Intervention|No intervention
16245541|NCT01042418|Other|Effect of breakfasts with whole vs milled rye kernels on appetite|Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
16245542|NCT01042392|Drug|Aliskiren|150 mg Aliskiren as film-coated tablet
16245543|NCT01042392|Drug|Ramipril|Ramipril 5 mg was given in capsule form.
16245544|NCT01042392|Drug|Matching placebo to Aliskiren|The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.
16245545|NCT01042392|Drug|Matching placebo to Ramipril|The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.
16245546|NCT01042379|Drug|Standard Therapy|Paclitaxel: 80 mg/m2 IV during the 12 weekly treatment cycles post randomization; Doxorubicin: 60 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16; Cyclophosphamide: 600 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16
16245547|NCT01042379|Drug|AMG 386 with or without Trastuzumab|Arm is closed.
16245548|NCT01042379|Drug|AMG 479 (Ganitumab) plus Metformin|Arm is closed.
16245549|NCT01042379|Drug|MK-2206 with or without Trastuzumab|Arm is closed.
16245550|NCT01042379|Drug|AMG 386 and Trastuzumab|Arm is closed.
16245551|NCT01042379|Drug|T-DM1 and Pertuzumab|Arm is closed.
16245552|NCT01042379|Drug|Pertuzumab and Trastuzumab|Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
16245553|NCT01042379|Drug|Ganetespib|Arm is closed.
16245554|NCT01042379|Drug|ABT-888|Arm is closed.
16245555|NCT01042379|Drug|Neratinib|Arm is closed.
16245556|NCT01042379|Drug|PLX3397|Arm is closed.
16245557|NCT01042379|Drug|Pembrolizumab - 4 cycle|Arm is closed.
16245558|NCT01042379|Drug|Talazoparib plus Irinotecan|Arm is closed.
16245559|NCT01042379|Drug|Patritumab and Trastuzumab|Arm is closed.
16245560|NCT01042379|Drug|Pembrolizumab - 8 cycle|Arm is closed.
16245561|NCT01042379|Drug|SGN-LIV1A|Arm is closed. SGN-LIV1A: 2.5 mg/kg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16
16245562|NCT01042379|Drug|Durvalumab plus Olaparib|Arm is closed.
16245563|NCT01042379|Drug|SD-101 + Pembrolizumab|Arm is closed. SD-101: IT injection 2 mg/ml (1 ml for T2 tumors, 2 ml for >T3 tumors) weekly x 4, then every 3 weeks x 2 cycles 1,2,3,4,7,10 Pembrolizumab: 200mg IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
16245564|NCT01042379|Drug|Tucatinib plus trastuzumab and pertuzumab|Arm is closed. Tucatinib: 300 mg PO BID 12 weeks CLOSED Tucatinib: 250 mg PO BID 12 weeks CLOSED Tucatinib adaptive: 150mg BID days 1-28, 250mg BID days 29-84 Trastuzumab: 4 mg/kg IV (loading dose) cycle 1; 2 mg/kg (thereafter) cycles 2-12 Pertuzumab: 840 mg IV (loading dose) cycle 1; 420 mg (thereafter) cycles 4, 7 and 10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
16245565|NCT01042379|Drug|Cemiplimab|Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
16245566|NCT01042379|Drug|Cemiplimab plus REGN3767|Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 REGN 3767: 1600 mg q3W X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
16245567|NCT01042379|Drug|Trilaciclib with or without trastuzumab + pertuzumab|"Trilaciclib: 240 mg/m2 IV weekly cycle 1-16 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
~For HER2+:
~Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization"
16245568|NCT01042379|Drug|SYD985 ([vic-]trastuzumab duocarmazine)|SYD985: 1.2 mg/kg IV (q3w x 12 weeks) cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
16245569|NCT01042379|Drug|Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab|"For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle
~For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle"
16245570|NCT01042379|Drug|Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab|"For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle
~For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle"
16245571|NCT01042379|Drug|Amcenestrant|Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks
16245572|NCT01042379|Drug|Amcenestrant + Abemaciclib|Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks
16245573|NCT01042379|Drug|Amcenestrant + Letrozole|Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Letrozole (Femara), 2.5mg QD, p.o., for 24 weeks
16245574|NCT01042366|Biological|Vaccination|Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
16245575|NCT01042353|Procedure|E test|At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method. The final E-test results will be compared with the standard MIC cultures.
16245576|NCT01042353|Procedure|standard culture method|BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures
16245577|NCT01042340|Other|Calogen® - an energy dense oleic acid based formula|A daily dose of 3 x 30 ml of Calogen®, strawberry flavour, distributed at the same time as the pharmaceutical prescriptions, i.e. at 7.00, 14.00 and 20.00.
16245578|NCT01042327|Device|ELISIO dialyzer|3 x week dialysis using ELISIO dialyzer for 12 weeks
16245579|NCT01042327|Device|Fresenius FX100 dialyzer|
16245580|NCT01042314|Drug|Donepezil|Tablets, Oral, 5 mg, Once Daily, Days 1-28
16245581|NCT01042314|Drug|BMS-708163|Capsule, Oral, 125 mg, Once Daily, Days 15-28
16245582|NCT01042301|Other|Blood samplings|
16245583|NCT01042288|Drug|Carboplatin|Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
16245584|NCT01042288|Drug|Pemetrexed|Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
16245585|NCT01042288|Drug|Panitumumab|Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
16245586|NCT01042262|Other|Oxygen|100% Oxygen at a flow of 2 L/min
16245587|NCT01042262|Other|Placebo|No oxygen flow
16245588|NCT01042249|Other|Pelvic Floor Muscle training|12 week training program including home exercises
16245589|NCT01042236|Drug|Fesoterodine|Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
16245590|NCT01042197|Radiation|Broadband UVB|UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
16245591|NCT01042197|Radiation|Broadband UVB|UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
16245592|NCT01042197|Radiation|Broadband UVB|UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
16245593|NCT01042197|Radiation|Broadband UVB|UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
16245594|NCT01042197|Radiation|Broadband UVB|UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
16245595|NCT01042197|Radiation|Broadband UVB|UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
16245596|NCT01042197|Radiation|Broadband UVB|UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
16245597|NCT01042197|Radiation|Broadband UVB|UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
16245598|NCT01042197|Radiation|Broadband UVB|UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
16245599|NCT01042184|Drug|Sequential therapy for 14 days|D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bi
16245600|NCT01042184|Drug|Sequential therapy for 10 days|D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
16245601|NCT01042184|Drug|Triple therapy for 14 days|D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
16245602|NCT01042158|Drug|tadalafil and ambrisentan upfront combination therapy|tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.
16245603|NCT01042145|Drug|Prednisone|2 mgs/kg for 3 days
16245604|NCT01042145|Drug|Dexamethasone|0.6 mgs for one day, then placebo for 2 days
16245605|NCT01042132|Procedure|the effect of delayed intramedullary reaming|in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.
16245606|NCT01042132|Procedure|the reaming of the femoral canal is performed with two different reaming devices|the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
16245607|NCT01042106|Drug|DSP-8658|Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
16245608|NCT01042106|Drug|Placebo|Placebo 2.5, 10, 20, 40 mg orally once daily
16245609|NCT01042093|Drug|Ropivacaine|Ropivacaine 5mg/ml (49.25 ml)
16245610|NCT01042093|Drug|Toradol|Toradol 30mg/ml (1 ml)
16245611|NCT01042093|Drug|Clonidine|Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
16245612|NCT01042093|Drug|Epinephrine|Epinephrine 1 mg/ml (0.5 ml)
16245613|NCT01042080|Device|NAVA|Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes
16245614|NCT01042080|Other|Expiratory trigger (ET)|Varying the cycling criterion according to the percentage of peak inspiratory flow
16245615|NCT01042067|Other|Blood specimens (whole blood, serum, plasma)|The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.
16245616|NCT01042054|Other|Standard optimised recovery protocol.|"Epidural analgesia for the first 48 hours postoperatively.
~Sham wound catheter attached to anterior abdominal wall, for purposes of blinding.
~Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
~Optimised recovery protocol followed throughout."
16245617|NCT01042054|Other|Wound catheter plus patient-controlled analgesia.|"Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively.
~Additional patient-controlled intravenous opiate analgesia available to patient during this time period.
~Sham epidural catheter applied to the patient's back for purposes of blinding.
~Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
~Optimised recovery protocol followed throughout."
16245618|NCT01042041|Drug|sorafenib tosylate|Given orally
16245619|NCT01042041|Drug|doxorubicin hydrochloride|Given via transarterial/hepatic chemoembolization
16245661|NCT01041781|Drug|carboplatin|Given IV
16245624|NCT01042028|Drug|Everolimus, Cetuximab, Irinotecan|Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
16245625|NCT01042028|Drug|Capecitabine, Oxaliplatine|Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
16245626|NCT01042015|Combination Product|Emergency preservation and resuscitation|This involves the induction of profound hypothermia using a flush of ice-cold saline into the aorta. Once hypothermia is achieved, the subject would undergo rapid operative interventions to control bleeding followed by resuscitation/rewarming with cardiopulmonary bypass.
16245627|NCT01042015|Other|Standard resuscitation|Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation.
16245628|NCT01042002|Behavioral|High intensity exercise|High intensity exercise 3xweek for minimum 6 weeks
16245629|NCT01041989|Behavioral|Nutritional guidance|Individual counseling sessions and group meetings will be organized.
16245630|NCT01041989|Behavioral|Exercise|Guided muscle strength training and aerobic exercise.
16245631|NCT01041989|Behavioral|Cognitive training|Cognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.
16245632|NCT01041989|Other|Reduction of vascular risk factors|Monitoring and maintenance of metabolic and vascular risk factors
16245633|NCT01041976|Behavioral|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
16245634|NCT01041976|Behavioral|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
16245635|NCT01041963|Drug|Enalapril|Patients with hypertension will take 20-40mg enalapril per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16245636|NCT01041963|Drug|Enalapril plus Losartan|Patients with hypertension will take 20-40mg enalapril plus 25-50mg losartan per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16245637|NCT01041963|Drug|Placebo|Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16245638|NCT01041950|Procedure|Lumbar drainage|Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
16245639|NCT01041937|Procedure|Cemented Tibia|Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking
16245640|NCT01041937|Procedure|Cementless Tibia|Assessing the clinical outcomes of the different type of fixation
16245641|NCT01041924|Other|Carbon dioxide|2% inhaled CO2 for up to 8 hours.
16245642|NCT01041924|Other|Carbon dioxide|Up to a maximum of 2% CO2, only delivered for a maximum of up to 20 seconds per 60 seconds for 8 hours
16245643|NCT01041911|Drug|Euphorbia tablets|50 mg, tablet, once daily, 14 days
16245644|NCT01041911|Drug|Euphorbia tablets|100 mg, tablet, once daily, 14 days
16245645|NCT01041911|Drug|Euphorbia tablets|200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
16245646|NCT01041911|Drug|Placebo tablets|placebo, tablet, once daily, 14 days
16245647|NCT01041885|Device|INSTRUCT|INSTRUCT PolyActive scaffold implantation
16245648|NCT01041872|Drug|Propofol Astrazeneca plain|Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
16245649|NCT01041872|Drug|Propofol Astrazeneca plus lidocaine|Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
16245650|NCT01041872|Drug|Propofol-lipuro B. Braun plain|Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
16245651|NCT01041872|Drug|Propofol-lipuro B. Braun plus lidocaine|Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
16245652|NCT01041872|Drug|Propofol Fresenius plain|Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
16245653|NCT01041872|Drug|Propofol Fresenius plus lidocaine|Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
16245654|NCT01041859|Drug|Tapentadol extended release (ER)|Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.
16245655|NCT01041859|Drug|Placebo|Form= tablet, route= oral use. Matching placebo twice daily.
16245656|NCT01041846|Drug|No intervention|This is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed.
16245657|NCT01041833|Drug|atRA|atRA group will receive six cycles of 80 mg/m2 of cisplatin and 175 mg/m2 of paclitaxel plus atRA 45 m2/day before one week before treatment and during all the treatment
16245658|NCT01041833|Drug|Placebo|Placebo group will receive six cycles of 80 mg/m2 of cisplatin and 175 mg/m2 of paclitaxel plus placebo before one week before treatment and during all the treatment
16245659|NCT01041820|Behavioral|Exercise|Children will be exposed to a 10-week exercise intervention
16245660|NCT01041807|Drug|amlodipine/losartan|amlodipine/losartan (COZAAR XQ) prescribed according to the current local label
16245666|NCT01041768|Procedure|Bariatric surgery|Biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve; Gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop
16245667|NCT01041755|Drug|L-ornithine-L-aspartate|a) Intravenous infusion of 20 g L-ornithine-L-aspartate (4 ampules of 10 mL each) in 250 mL sodium chloride solution administered daily in 4 hours for 3 consecutive days, plus the placebo b) Water enemas, 1000 mL of water and given as retention enema every 12 hours for 3 consecutive days.
16245668|NCT01041755|Drug|Lactose|a) 20% Lactose enemas, 200 g Lactose diluted with 700 mL of water and given as retention enema every 12 hours for 3 consecutive days, plus intravenous placebo b)250 mL sodium chloride solution, infusion for 4 hours for 3 consecutive days.
16245669|NCT01041742|Procedure|fluid loading|fluid loading will be performed by using 6% hydroxyethyl starch solution , at 10 mL/kg.
16245670|NCT01041729|Drug|Atorvastatin|Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
16245671|NCT01041729|Drug|Standard Medical Treatment|"Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months.
~Standard Medical Treatment."
16245672|NCT01041716|Other|None - Observational study|None - Observational study
16245673|NCT01041690|Drug|Bevacizumab|
16245674|NCT01041677|Drug|R256918|10 mg capsule twice daily
16245675|NCT01041677|Drug|placebo|placebo capsule twice daily
16245676|NCT01041677|Drug|R256918|15 mg capsule twice daily
16245677|NCT01041638|Biological|Aldesleukin|Given IV
16245678|NCT01041638|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16245679|NCT01041638|Biological|Dinutuximab|Given IV
16245680|NCT01041638|Drug|Isotretinoin|Given PO
16245681|NCT01041638|Biological|Sargramostim|Given IV or SC
16245682|NCT01041625|Drug|Apremilast (CC-10004)|Apremilast 20 mg tablet PO administered BID over 12 weeks
16245683|NCT01041612|Device|PTFE Covered ComVi [full covered] Biliary Stent|The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
16245684|NCT01041612|Device|PTFE Covered ComVi [full covered] Biliary Stent|The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
16245685|NCT01041586|Device|BTVA System|Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
16245686|NCT01041573|Biological|IC51 Japanese Encephalitis|6 mcg or 3 mcg im. at day 0 and day 28
16245687|NCT01041573|Biological|Havrix®720|0.5 ml im. at day 0 and month 7
16245688|NCT01041573|Biological|Prevnar|0.5 ml im. at day 0 and day 56 and month 7
16245689|NCT01041534|Other|Survey|Two surveys are sent to patients: Adjustable gastric band (AGB) Health Survey and a quality of life survey (EQ5D)
16245690|NCT01041521|Drug|Lovaza|Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
16245691|NCT01041508|Drug|Clofarabine|Clofarabine will be given as an intravenous infusion over 2 hours on days -6 though -2. The dose of Clofarabine will be assigned at study entry.
16245692|NCT01041508|Radiation|Total Body Irradiation|"Low dose (2 Gy) TBI will be administered from a linear accelerator at ≤ 20 cGy/min on day 0 according to institutional guidelines."
16245693|NCT01041508|Other|Stem Cell Infusion|Patients will be infused with 'unmanipulated' hematopoietic stem cells from a related or unrelated donor on day 0 of the treatment regimen according to institutional practice guidelines.
16245694|NCT01041508|Drug|Cyclosporins|"Cyclosporin (CSP) should be started on day -1 after completion of Clofarabine. CSP levels should be maintained between 300-400 ng/ml.
~Age ≤ 6 years old: 6 mg/kg IV QD. in divided doses (e.g. 2 mg/kg q8hrs). Age > 6 years old: 3 mg/kg IV QD in divided doses (1.5mg/kg q12hrs)"
16245695|NCT01041508|Drug|Mycophenolate mofetil|Mycophenolate mofetil (MMF) will be at 15 mg/kg, based on adjusted body weight, every 8 hours (45 mg/kg/day; max.3g/day) PO, or IV if indicated, from the evening of day 0 (i.e. first dose 4-6 hours following stem cell infusion) to day +40 post-transplant.
16245696|NCT01041495|Drug|cyclobenzaprine ER (AMRIX)|active drug
16245697|NCT01041495|Drug|placebo|matching placebo for AMRIX
16245698|NCT01041482|Drug|sorafenib|sorafenib 400mg twice daily
16245699|NCT01041443|Drug|5-fluoro-2-deoxycytidine|Given IV
16245700|NCT01041443|Drug|tetrahydrouridine|Given IV
16245701|NCT01041443|Other|laboratory biomarker analysis|Correlative studies
16245702|NCT01041443|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16245703|NCT01041443|Genetic|DNA methylation analysis|Correlative studies
16245704|NCT01041430|Other|day surgery group|inguinal hernia repair, discharge from the hospital on the day of surgery
16245705|NCT01041430|Other|inpatient group|inguinal hernia repair, patient admitted overnight to hospital
16245706|NCT01041417|Drug|Granulocyte-Macrophage Stimulating Factor (GM-CSF)|500 micrograms of GM-CSF
16245707|NCT01041417|Drug|Placebo|Saline injection
16245708|NCT01041404|Drug|Trastuzumab|Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression
16245709|NCT01041404|Drug|Fluorouracil|800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles
16245710|NCT01041404|Drug|Cisplatin|80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles
16245711|NCT01041404|Drug|Capecitabine|1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles
16245712|NCT01041391|Procedure|Discectomy-lumbar spine|Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention
16245713|NCT01041378|Drug|dexamethasone|Intravenous dexamethasone (0.5mg/kg) before incision
16245714|NCT01041352|Device|laryngeal mask|LMA Proseal
16245715|NCT01041352|Device|endotracheal tube|Unomedical endotracheal tube
16245716|NCT01041326|Radiation|Radiation|Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
16245795|NCT01040728|Drug|Placebo (for Olodaterol (BI1744)l)|Placebo (olodaterol low and high dose) delivered by Respimat
16245717|NCT01041326|Procedure|Radical Prostatectomy|Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches.
16245718|NCT01041313|Drug|Memantine|7 days prior to surgery, start taking 5mg memantine daily; 4 days prior to surgery, increase dose to 5mg twice daily; 2 days prior to surgery, increase dose to 10mg in the morning, and 5 mg in the evening; on the day of surgery, increase dose to 10mg twice daily, and continue on this dose until 14 days after surgery.
16245719|NCT01041313|Drug|Placebo|7 days prior to surgery, start taking one placebo tablet daily; 4 days prior to surgery, increase dose to one placebo tablet twice daily; 2 days prior to surgery, increase dose to 2 placebo tablets in the morning, and one placebo tablet in the evening; on the day of surgery, increase dose to 2 placebo tablets in the morning and 1 placebo tablet in the evening. On the first day after surgery through 14 days after surgery, take 1 placebo tablet twice daily.
16245720|NCT01041300|Device|Magstim Rapid2 Stimulator|"Duration: Time is takes to find motor thresholds obtained with figure-8 coil using Magstim Rapid2 Stimulator (Estimated at 15 minutes).
~Total Duration of device: 15 minutes"
16245721|NCT01041300|Device|Brainsway Multi-channel Stimulator|"Finding motor thresholds using the figure-8 coil and the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
~Finding motor threshold of leg obtained with Double Cone coil using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
~Finding motor threshold of leg obtained with circular coils using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
~Finding motor threshold of thumb obtained with circular coils on multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
~Finding motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 1 hour).
~Finding specificity of the motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 30 minutes).
~Total Duration with Device: 2 hours and 30 minutes"
16245722|NCT01041287|Drug|Nebivolol|Nebivolol 5 mg PO qday for 2 weeks, titrated up to Nebivolol 10 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Nebivolol 20 mg PO qday if BP is >125/80 for the remaining 8 weeks
16245723|NCT01041287|Drug|Metoprolol succinate|Metoprolol 50 mg PO qday for 2 weeks, titrated up to Metoprolol 100 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Metoprolol 200 mg PO qday if BP is >125/80 for the remaining 8 weeks
16245724|NCT01041274|Drug|Citalopram|40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.
16245725|NCT01041274|Drug|Placebo|Placebo by mouth daily for 12 months.
16245726|NCT01041274|Behavioral|Psychoeducation|16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions
16245727|NCT01041274|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI
16245728|NCT01041274|Radiation|Functional Magnetic Resonance Imaging (fMRI)|3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
16245729|NCT01041261|Dietary Supplement|BariatrX Essentials 360 Treatment|Medical food
16245730|NCT01041248|Drug|Tocilizumab|8mg/kg every 2 weeks i.v.
16245731|NCT01041235|Drug|ATI-1123 (active drug = docetaxel)|Dose escalation starting at 15 mg/m2 given once every 3 weeks via IV
16245732|NCT01041222|Drug|ISIS 333611|5 arms of 12 hour infusion: Arm 1 0.15 mg, Arm 2 0.5 mg, Arm 3 1.5 mg, Arm 4 3.0 mg, matching volume of placebo
16245733|NCT01041209|Behavioral|Strategy based on BPS guided antibiotic use|In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
16245734|NCT01041209|Behavioral|Enforced Guidelines|In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
16245735|NCT01041183|Drug|intravenous ramosetron|0.3 mg IV ramosetron (group I)
16245736|NCT01041183|Drug|oral ramosetron|0.1 mg oral ramosetron (group II)
16245737|NCT01041183|Drug|oral and IV ramosetron|0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).
16245738|NCT01041170|Drug|THC|
16245739|NCT01041170|Drug|Rimonobant|
16245740|NCT01041170|Drug|Rimonabant|
16245741|NCT01041157|Other|Resistance training|Neck muscle trainings effect on botulinum toxin efficiency
16245742|NCT01041144|Behavioral|lifestyle counseling|supporting diabetes patients using Internet communication
16245743|NCT01041092|Drug|raloxifene|Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks.
16245744|NCT01041066|Drug|labetalol|0.4 mg/kg labetalol intravenously 4 min before intubation
16245745|NCT01041066|Drug|nicardipine|20 ㎍/kg nicardipine intravenously 4 min before intubation
16245746|NCT01041040|Drug|gemtuzumab|gemtuzumab ozogamicin (GO) during consolidation for patients with acute myeloid leukemia (AML)
16245747|NCT01041027|Drug|Paclitaxel|Given IV
16245748|NCT01041027|Drug|Carboplatin|Given IV
16245749|NCT01041027|Radiation|Internal Radiation Therapy|Undergo HDR brachytherapy
16245750|NCT01041027|Radiation|External Beam Radiation Therapy|Undergo EBRT
16245751|NCT01041027|Other|Laboratory Biomarker Analysis|Correlative studies
16245752|NCT01041014|Behavioral|Professional medical interpreter|All treatment interpreters were certified bilingual in Spanish and English and had completed (1) at least 40 hours of training in medical terminology, ethics, patient privacy, and basic interpreting skills; and (2) an online course in protection of human subjects.
16245753|NCT01041001|Biological|Cartistem|allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product
16245754|NCT01041001|Procedure|Microfracture treatment|
16245796|NCT01040728|Drug|Placebo (for Tiotropium)|Placebo (Tiotropium 18 mcg) delivered by HandiHaler
16245755|NCT01040975|Behavioral|Web-based intervention targeting MD communication; Summary Report|Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team
16245756|NCT01040949|Behavioral|couple-based counseling for smoking cessation plus self-help smoking cessation guide|Culturally sensitive couple-based counseling for smoking cessation plus self-help smoking cessation guide in Latino men with pregnant partners
16245757|NCT01040949|Behavioral|Guia -a self help smoking cessation guide|A culturally sensitive smoking cessation self help program for Latinos
16245758|NCT01040936|Drug|Atorvastatin|patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year
16245759|NCT01040936|Drug|Atorvastatin|patients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China
16245760|NCT01040923|Device|CardioSond Cardiac Sonospectrographic Analyzer|The CardioSond is a completely noninvasive, FDA 510(k) cleared digital electronic stethoscope designed to detect heart sounds and murmurs using ultrasensitive acoustic technology.
16245761|NCT01040910|Drug|smoking of cannabis|smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
16245762|NCT01040910|Drug|smoking cigarettes with placebo|smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
16245763|NCT01040897|Behavioral|Health Communication and Obesity Prevention|Pediatric residents will be training in effective health communication skills and given a literacy/numeracy sensitive toolkit (GreenLight) to use with parents during all well child visits from 2 months to 18 months.
16245764|NCT01040897|Behavioral|Injury Prevention Arm|Pediatric residents will be trained to address injury prevention using the American Academy of Pediatrics (AAP) TIPP materials.
16245765|NCT01040884|Other|ActiSight Needle Guidance System|ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera
16245766|NCT01040871|Drug|VELCADE|VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
16245767|NCT01040871|Drug|Rituximab|Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
16245768|NCT01040871|Drug|Cyclophosphamide|Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
16245769|NCT01040871|Drug|Doxorubicin|Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
16245770|NCT01040871|Drug|Prednisone|Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
16245771|NCT01040871|Drug|Vincristine|Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
16245772|NCT01040858|Behavioral|Cognitive Strategy Training|Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks.
16245773|NCT01040858|Other|Placebo comparison group|Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study).
16245774|NCT01040845|Drug|Norethindrone/Ethinyl Estradiol|one tablet daily - 1 mg norethindrone/0.035 mg ethinyl estradiol on Days 1 to 21; inert ingredients on Days 22 to 28
16245775|NCT01040845|Drug|Colchicine|0.6mg tablet every 12 hours on Days 8 to 21
16245776|NCT01040845|Drug|Placebo (for Colchicine)|placebo tablet every 12 hours on Days 8 to 21
16245777|NCT01040832|Drug|Cetuximab|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) will be administered in 3-week treatment cycle until disease progression. The total treatment period will be approximately 18 months.
16245778|NCT01040832|Drug|EMD 1201081|EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) will be administered in 3-week treatment cycle until disease progression. Subjects who will discontinue cetuximab due to toxicity in cetuximab monotherapy, could continue to receive EMD 1201081 monotherapy until disease progression. The total treatment period will be approximately 18 months.
16245779|NCT01040819|Drug|Pioglitazone|Patients will receive PIO 15 mg/d for one month, then 55 patients continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. Other non-diabetes drugs should not be changed. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited.
16245780|NCT01040806|Behavioral|Usual care|Patients will receive their usual medical care
16245781|NCT01040806|Behavioral|Health coaching|Peer health coaches will counsel patients with diabetes
16245782|NCT01040793|Drug|Olodaterol (BI 1744)|Comparison of low and high dose on exercise endurance time in COPD patients
16245783|NCT01040793|Drug|Olodaterol (BI 1744)|Comparison of low and high dose on exercise endurance time in COPD patients
16245784|NCT01040793|Drug|Placebo|Comparison of low and high dose and placebo on exercise endurance time in COPD patients
16245785|NCT01040793|Drug|Olodaterol (BI1744)|Comparison of low and high dose on exercise endurance time in COPD patients
16245786|NCT01040793|Drug|Olodaterol (BI 1744) placebo|Placebo that represents olodaterol
16245787|NCT01040780|Drug|Icotinib|125 mg three times daily (375 mg per day) by mouth
16245788|NCT01040780|Drug|Gefitinib|250 mg every 24 hours by mouth
16245789|NCT01040767|Other|Didactic training in basic ultrasound and the EFAST|Physicians in the classroom group (class) listened to traditional lectures, while the web group (web) watched narrated lectures online. All participants completed a pre- and post-test, and a second post-test eight weeks later. Both groups underwent hands-on training after the first post-test.
16245790|NCT01040754|Other|Acupuncture|This study follows a standardized acupuncture protocol for OA knee pain. Approximately 6 acupuncture needles are placed in the skin of the leg for 25 minutes.
16245791|NCT01040741|Other|Non-intervention observational study|Non-intervention observational study
16245792|NCT01040728|Drug|Olodaterol (BI1744) Low|Low dose inhaled orally once daily from Respimat inhaler
16245793|NCT01040728|Drug|Olodaterol (BI1744) High|High dose inhaled orally once daily from Respimat inhaler
16245794|NCT01040728|Drug|Tiotropium 18 mcg|18 mcg inhaled once daily from HandiHaler
16245797|NCT01040715|Biological|TNFa Kinoid|TNFa kinoid
16245798|NCT01040715|Biological|TNF kinoid|IM administration 2 or 3 injections within 28 days
16245799|NCT01040702|Drug|methylphenidate|a single doses of 10-20 mg in each one of two visits
16245800|NCT01040702|Dietary Supplement|sweetener pill|a capsule containing a sweetener pill
16245801|NCT01040689|Drug|Olodaterol (BI1744) Low|Low dose inhaled orally once daily from Respimat inhaler
16245802|NCT01040689|Drug|Placebo (for olodaterol BI1744)|Placebo (olodaterol low and high dose)delivered by Respimat
16245803|NCT01040689|Drug|Placebo (for Tiotropium)|Placebo (Tiotropium 18 mcg) delivered by HandiHaler
16245804|NCT01040689|Drug|Olodaterol (BI1744) High|High dose inhaled orally once daily from Respimat inhaler
16245805|NCT01040689|Drug|Tiotropium 18 mcg|18mcg inhaled once daily from Handihaler
16245806|NCT01040676|Behavioral|Automated Telephone Nutrition Support|See Intervention Group description.
16245807|NCT01040663|Other|Dietary intervention|Subjects will be randomly assigned to receive 1 of 3 diets for 4 weeks.
16245808|NCT01040637|Drug|TD-1211|Dose level 1
16245809|NCT01040637|Drug|TD-1211|Dose level 2
16245810|NCT01040637|Drug|TD-1211|Dose level 3
16245811|NCT01040637|Drug|TD-1211|Dose Level 4
16245812|NCT01040637|Drug|TD-1211|Ascending doses
16245813|NCT01040637|Drug|TD-1211|Ascending doses
16245814|NCT01040637|Drug|TD-1211|Ascending doses
16245815|NCT01040637|Drug|TD-1211|Ascending doses
16245816|NCT01040637|Drug|TD-1211|Ascending doses
16245817|NCT01040637|Drug|Placebo|Ascending doses
16245818|NCT01040624|Radiation|< 15% risk of + LN|Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
16245819|NCT01040624|Radiation|> 15% risk of + LN|Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
16245820|NCT01040611|Behavioral|Music therapy|Patients who fit the inclusion criteria were random assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days.
16245821|NCT01040598|Biological|Omalizumab|Omalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required.
16245822|NCT01040585|Drug|Linezolid|Treatment for VAP as indication approved and as physician criterium.
16245823|NCT01040559|Drug|idarubicin|Transarterial chemoembolization (in the hepatic artery) with idarubicin 5mg or 10 mg or 15 mg or 20 mg or 25 mg injected in a solution of 2ml DC Bead (300 µm-500µm); 1 unique course
16245824|NCT01040546|Behavioral|Individualized education|"We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into individualized health education group, group weight control education and mail-delivered health education group.Obese subjects who were randomly allocated into individualized health education group received consulting services provided by a doctor, nutritionist and fitness expert. The interventions were 12 sessions over 6 months."
16245825|NCT01040546|Behavioral|Grouped education|"We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into individualized health education group, group weight control education and mail-delivered health education group.Obese subjects who were randomly allocated into grouped health education group attended 12 sessions of group intervention over 6 months."
16245826|NCT01040494|Drug|Aliskiren|all eligible patients will be randomized to receive aliskiren 150 mg on top of optimal HF therapy, including ACEI, ARB, beta blockers as considered appropriate by the investigator and in accordance with standard therapy guidelines for 6 months
16245827|NCT01040494|Drug|Placebo|all eligible patients will be randomized to receive placebo on top of optimal HF therapy, including ACEI, ARB, beta blockers as considered appropriate by the investigator and in accordance with standard therapy guidelines for 6 months
16245828|NCT01040468|Procedure|Roux-en-Y Gastric Bypass surgery|Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
16245829|NCT01040468|Procedure|Laparoscopic Adjustable Gastric Banding surgery|Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
16245830|NCT01040468|Behavioral|Intensive Lifestyle Modification|Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day).
16245831|NCT01040455|Drug|Lansoprazole|lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
16245832|NCT01040455|Drug|placebo|placebo once daily for eight weeks
16245833|NCT01040442|Other|vibration stimuli|A single physical therapist performed the intervention using a Novafon SK2‡ vibratory stimulation device at a frequency of 100 Hz and sway amplitude of 2 mm. The participants of the experimental group received vibratory stimulation, applied slowly by sliding the head of the device over the entire plantar region for ten minutes for each foot at every session. During the intervention, the participants remained in the supine position on an examination table.
16245923|NCT01039740|Drug|Mirtazapine|Mirtazapine administration for 6 weeks under therapeutic dose
16246246|NCT01037101|Behavioral|In Vivo Exposure Therapy|Three hours of exposure therapy in a high place
16245834|NCT01040429|Drug|Clonidine|"Day 1-56 (week 1-8): 25 microgram (1 capsula) x 2/day for patients < 35 kg; 50 microgram (2 capsula) x 2/day for patients > 35 kg.
~Day 57-63 (week 9): 25 microgram (1 capsula) x 1/day for patients < 35 kg; 25 microgram (2 capsula) x 2/day for patients > 35 kg."
16245835|NCT01040429|Drug|Lactose capsula|"Day 1-56 (week 1-8): 1 capsula x 2/day for patients < 35 kg; 2 capsula x 2/day for patients > 35 kg.
~Day 57-63 (week 9): 1 capsula x 1/day for patients < 35 kg; 1 capsula x 2/day for patients > 35 kg"
16245836|NCT01040403|Drug|olodaterol (BI 1744) low|olodaterol (BI 1744) low
16245837|NCT01040403|Drug|low tiotropium bromide|low tiotropium bromide
16245838|NCT01040403|Drug|olodaterol (BI 1744) high|olodaterol (BI 1744) high
16245839|NCT01040403|Drug|medium tiotropium bromide|medium tiotropium bromide
16245840|NCT01040403|Drug|high tiotropium bromide|high tiotropium bromide
16245841|NCT01040403|Drug|Placebo|Placebo
16245842|NCT01040403|Device|Respimat|Respimat inhaler
16245843|NCT01040390|Drug|Lappa Arctium|To start with subjects will be prescribed Lappa Arctium in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
16245844|NCT01040351|Procedure|ultrasound guided aspiration of hydrosalpingeal fluid|Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
16245845|NCT01040338|Drug|Nicotine|Participants shall receive an intravenous injection of nicotine during their practice session and one of their PET scans (double-blind). The dose of IV nicotine will be 1mg/70kg and the maximum dose that shall be injected is 1.2mg.
16245846|NCT01040325|Biological|TD Vaccine System|TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
16245847|NCT01040325|Biological|TD Vaccine System|TD Vaccine System Containing Placebo Product
16245848|NCT01040312|Drug|CPT-11|CPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.
16245849|NCT01040312|Drug|Platinum analogues|Platinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs.
16245850|NCT01040299|Device|GangTrainer and tDCS|The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.
16245851|NCT01040299|Device|control group1|The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
16245852|NCT01040299|Other|Control group2|The control group 2 receive a total of 10 treatments with convectional physiotherapy.
16245853|NCT01040286|Drug|Flurbiprofen|2.0 mg
16245854|NCT01040286|Drug|Chlorhexidine|2.5mg
16245855|NCT01040273|Drug|Bupivacaine|
16245856|NCT01040273|Drug|Placebo|
16245857|NCT01040260|Other|Counseling|Smoking cessation counseling
16245858|NCT01040260|Behavioral|Contingency management|Use of tangible rewards for abstinence from smoking
16245859|NCT01040260|Drug|Nicotine patches|Nicotine patches
16245860|NCT01040247|Other|Embryo Transfer|In the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice.
16245861|NCT01040234|Procedure|Bilateral dual TAP block|Bupivacaine 2.5 mg/ml 15 ml per injection. 4 injections per patient according to dual TAP block procedure
16245862|NCT01040221|Drug|Trichuris Suis Ova|TSO will be administered in vials prepared by Coronado Biosciences. Vials will be diluted with a commercial drink and given to subjects to ingest. Subjects will receive a dose of 2500 ova every two weeks for 12 weeks.
16245863|NCT01040208|Drug|flibanserin 50 mg to 100 mg qhs|50 to 100mg qhs
16245864|NCT01040208|Drug|flibanserin 100 mg qhs|100mg qhs
16245865|NCT01040208|Drug|placebo 2 tablets qhs|50 mg placebo
16245866|NCT01040195|Drug|Methotrexate, Hydroxychloroquine|Methotrexate will be prepared as unmarked tablets of 2.5 mg strength each and Hydroxychloroquine as unmarked tablet of 200 mg strength. Patients will be started on Methotrexate/placebo at 10 mg once weekly and increased every week by 2.5 mg to maximum dose of 20 mg per week in the absence of side effects. These patients will also be started on Hydroxychloroquine 200 mg per day or placebo.
16245867|NCT01040195|Drug|Placebo|Identical placebos (for methotrexate and hydroxychloroquine)will be prepared and prescribed in identical fashion as the methotrexate and hydroxychloroquine in the combination DMARD arm.
16245868|NCT01040169|Device|Arginine/Calcium Carbonate|One application
16245869|NCT01040169|Device|Mint Prophy paste - Fluoride free|one application
16245870|NCT01040130|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on exercise endurance time in COPD patients
16245871|NCT01040130|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on exercise endurance time in COPD patients
16245872|NCT01040130|Drug|Placebo|Comparison of low and high dose and placebo on exercise endurance time in COPD patients
16245873|NCT01040130|Drug|Olodaterol (BI 1744)|Comparison of low and high dose
16245874|NCT01040130|Drug|Olodaterol (BI 1744) Placebo|Placebo that represents olodaterol
16245875|NCT01040117|Procedure|Sensory-motor Integration Training|Exercises will be divided into 3 levels. 1 Starting from the patient's most stable and comfortable standing position. 2 Patient will perform a single-step simulation, shifting his/her weight from one foot to the other in a frontal direction. 3 Patient will perform rapid movements, alternating feet in many directions, progressively increasing weight shifting and decreasing the support base amplitude. In the first five sessions exercises will be performed on a stable surface. During the remaining sessions patients will perform exercises on a compliant surface. During the two training periods the patient's visual condition will be progressively changed.
16245922|NCT01039766|Drug|placebo - saline nasal spray|A single intranasal administration of saline will be given to patients up to 6 hours after a traumatic event, with consecutive follow up for 13 months as the control to the oxytocin arm
16245876|NCT01040117|Procedure|Conventional neurorehabilitation treatment|"The treatment will be consist in active joint mobilization, muscle stretching and strengthen and motor coordination exercises. In the first part of each session the active joint mobilization will be carried out while the patient was lying on a carpet in supine, prone. The training will continue with muscle stretching and strengthen exercises performed while patient will be in supine, prone (when possible) and standing.
~Motor coordination exercises will be carried out in supine position while sitting on a bench and in the standing position with a front support or with against a wall. The patient will be required to performed a total of 10 exercises with the following sequence: 6 exercises in supine position, 2 exercises in sitting position and 2 in standing position."
16245877|NCT01040104|Other|Skin sample|Taken from regularly discarded tissue during routine operation
16245878|NCT01040104|Other|Skin biopsy|Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
16245879|NCT01040104|Other|Skin biopsy|Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
16245880|NCT01040104|Other|Blood taking|Blood taking on day 0
16245881|NCT01040104|Other|Blood taking|Blood taking on day 90
16245882|NCT01040091|Drug|Emtricitabine (FTC)|200 mg once a day
16245883|NCT01040091|Drug|Tenofovir disoproxil fumarate (TDF)|300 mg once a day
16245884|NCT01040091|Drug|Efavirenz (EFV)|600 mg once a day
16245885|NCT01040091|Drug|Truvada|200 mg emtricitabine + 300 mg TDF once a day
16245886|NCT01040078|Biological|7.5ug H1N1 Influenza vaccine|0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
16245887|NCT01040078|Biological|15ug H1N1 vaccine|0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
16245888|NCT01040078|Biological|seasonal influenza vaccine|0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
16245889|NCT01040065|Procedure|distal clavicle resection|Presence of tenderness at 2 years after surgery
16245890|NCT01040052|Biological|Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)|0.5 mL, Intramuscular
16245891|NCT01040026|Other|Treatment with in vitro expanded haploidentical NK cells|10 expanded NK-DLI will be applied at fixed intervals and to each patient within 30 days (3 applications per week, Mo/We/Fr) starting with increasing CD56+CD3- NK cell doses at 3 dose levels (1.5x10e6/kg, 1.5x10e7/kg and 1x10e8/kg) and, if safe, continuing with maximally 7 doses of 1x10e8/kg. Maximal cumulative T-cell dose is fixed at <1x10e5/kg
16245892|NCT01040013|Procedure|Laparoscopy|Laparoscopic Left-Colectomy
16245893|NCT01040013|Procedure|left colectomy by laparotomy|PatientS will be operated by laparotomy
16245894|NCT01040000|Drug|NPC-1C/NEO-102|Subjects will receive NPC-1C at a dose of 3.0 mg/kg. NPC-1C will be given intravenously (by vein) over approximately 1-6 hours, once every 2 weeks for 4 doses per course. Courses will be repeated in the absence of disease progression or unacceptable toxicity.
16245895|NCT01039974|Drug|GSK962040|"GSK962040. Planned doses per cohort as follows:
~Cohort 1 planned dose = 10 mg; Cohort 2 to be determined based on data from Cohort 1"
16245896|NCT01039974|Drug|Ketoconazole|400 mg
16245897|NCT01039961|Drug|losmapimod 1 mg|IV infusion
16245898|NCT01039961|Drug|losmapimod|IV infusion (dose to be determined based on PK from first dose)
16245899|NCT01039961|Drug|losmapimod 15 mg|oral, two 7.5 mg tablets
16245900|NCT01039948|Biological|AV-299 + gefitinib|AV-299 is a humanized anti-HGF IgG1 monoclonal antibody directed against free HGF, ligand for c-Met tyrosine kinase receptor.
16245901|NCT01039948|Drug|Gefitinib|Gefitinib is a small molecule (drug) which selectively inhibits epidermal growth factor receptor's (EGFR) tyrosine kinase domain.
16245902|NCT01039909|Drug|Placebo|"For the placebo product, SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
~Eight size 00 Swedish orange opaque hard gelatin capsules containing placebo are stored in a dosing bottle and provided to all participating subjects for oral ingestion."
16245903|NCT01039909|Drug|SRT2104|SRT2104 investigational product is a size 00 Swedish Orange opaque hard gelatin capsule containing 0.25 g of SRT2104, a new chemical entity which is supplied as a micronized, yellowish/amber powder. Eight SRT2104 capsules are stored in a dosing bottle and provided to all participating subjects for oral ingestion.
16245904|NCT01039896|Drug|Period I : SLM0807, Period II : HKB0701 and SLM0807|
16245905|NCT01039896|Drug|Period I : HKB0710 and SLM0807, Period II : SLM0807|
16245906|NCT01039883|Drug|Albaconazole tablet 400mg|Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose
16245907|NCT01039883|Drug|Albaconazole 100mg capsules, then albaconazole 400mg tablet|Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose
16245908|NCT01039870|Procedure|paravertebral block|postoperative pain is controlled with local analgesics delivered via PVB
16245909|NCT01039870|Procedure|thoracic epidural analgesia|postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter
16245910|NCT01039857|Behavioral|Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy|
16245911|NCT01039857|Behavioral|Integrative Neuro-Psychotherapy|Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
16245912|NCT01039844|Drug|LOC-paclitaxel|"Phase I Starting Dose: 100 mg/m^2 IV (intravenously) 1 hour infusion on Day 1, 8, 15, 22 and 29; and repeated every 42 days (6 weeks) per cycle.
~Phase II Starting Dose: Maximum tolerated dose from Phase I."
16245913|NCT01039818|Radiation|Radioiodine|A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
16245914|NCT01039818|Radiation|Radioiodine|A unique dose of 250µCi of ¹³¹I/ml/24-RAIU
16245915|NCT01039805|Drug|GSK962040 (50 mg)|Cohort 1 = 50 mg
16245916|NCT01039805|Drug|Placebo|matching placebo
16245917|NCT01039805|Drug|GSK962040 (75 mg)|Cohort 2 = 75 mg
16245918|NCT01039792|Drug|Methyl B12|75 µg/Kg subcutaneously injected once every 3 days
16245919|NCT01039792|Dietary Supplement|Placebo|placebo
16245920|NCT01039779|Behavioral|Exercise|Exercise will be taught every week over the 6-month intervention period at a subject's residence by instructors.
16245921|NCT01039766|Drug|Oxytocin|A single intranasal administration of 40 IU of oxytocin will be given to patients up to 6 hours after a traumatic event, with consecutive follow up for 13 months.
16245924|NCT01039727|Other|care as usual + 5 specific CDs|care as usual + 5 specific CDs (3 'General pain relief' + 2 'Short relaxations')
16245925|NCT01039727|Other|care as usual + email assistance + AurelisOnLine (AoL) + CDs|care as usual + email assistance (password protected) + AurelisOnLine (AoL) + 5 CDs at the start (same as in arm 2) + more CDs as needed after 1 month
16245926|NCT01039701|Drug|AZD1446|capsules, oral, 3 times daily
16245927|NCT01039701|Drug|Placebo|capsules, oral, 3 times daily, 4 weeks
16245928|NCT01039688|Drug|CP-690,550|Oral tablets administered at a dose of 5 mg BID for 24 months
16245929|NCT01039688|Drug|CP-690,550|Oral tablets administered at a dose of 10 mg BID for 24 months
16245930|NCT01039688|Drug|Disease-modifying antirheumatic drug|Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
16245931|NCT01039675|Drug|500mcg/25mcg once daily|GSK573719/GW642444
16245932|NCT01039675|Drug|Placebo once daily|Inactive, excipients only
16245933|NCT01039662|Dietary Supplement|L-arabinose and indigestible dextrin|
16245934|NCT01039662|Dietary Supplement|Placebo|
16245935|NCT01039636|Drug|FBS0701|Oral FBS0701 for 7 days at one of the following doses: 3 mg/kg/day or 8 mg/kg/day or 16 mg/kg/day or 32 mg/kg/day or 40 mg/kg/day
16245936|NCT01039623|Biological|Pandemrix® (H1N1 pandemic influenza)|vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant.
16245937|NCT01039610|Drug|GSK945237|Dose detailed in Arm description
16245938|NCT01039610|Drug|Placebo|matching placebo tablet
16245939|NCT01039610|Drug|Linezolid|600 mg BID, 14 Days
16245940|NCT01039610|Drug|Moxifloxacin|40 mg single dose
16245941|NCT01039597|Drug|ORE1001|Oral capsules containing 300 mg of the active, study drug
16245942|NCT01039597|Drug|Placebo|placebo capsules
16245943|NCT01039584|Drug|Butoconazole Nitrate Vaginal Cream|vaginal cream
16245944|NCT01039584|Drug|Placebo|vaginal cream
16245945|NCT01039584|Drug|Gynazole 1 vaginal cream|vaginal cream
16245946|NCT01039571|Procedure|double row repair|double row repair for torn rotator cuff were performed to compare with the conventional single row repair
16245947|NCT01039558|Drug|ecabet sodium|Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
16245948|NCT01039558|Drug|lansoprazole|Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
16245949|NCT01039558|Drug|placebo|Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
16245950|NCT01039545|Drug|Diclofenac|Diclofenac retard 75mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary
16245951|NCT01039545|Drug|Norfloxacin|Norfloxacin 400mg twice daily for 3 days, followed by fosfomycin 3g single dose on day 4 if deemed necessary
16245952|NCT01039519|Drug|Ganetespib|Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
16245953|NCT01039506|Drug|CPT-11 based regimens|
16245954|NCT01039467|Device|Medtronic Adapta Dual Chamber Pacemaker|Medtronic Adapta Dual Chamber Pacemaker
16245955|NCT01039454|Drug|GSK598809 Capsules|GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.
16245956|NCT01039454|Drug|GSK598809 Placebo Capsules|Treatment of substance dependence and potentially other impulse control disorders.
16245957|NCT01039441|Procedure|Intraperitoneal instillation of bupivacaine|A mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm.
16245958|NCT01039441|Procedure|CO2 removal by means of a pulmonary recruitment maneuver|CO2 is removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O
16245959|NCT01039441|Procedure|Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver|
16245960|NCT01039441|Other|normal saline|
16245961|NCT01039428|Dietary Supplement|HS219|Chewing for 30 min three time a day far after meal
16245962|NCT01039428|Dietary Supplement|Placebo|Chewing for 30 min three times a day far after meal
16245963|NCT01039389|Drug|Ivabradine|bid administration of 5mg ivabradine (max 7.5mg) aiming to reduce resting heart rate to 60/min
16245964|NCT01039389|Drug|Placebo|bid placebo
16245965|NCT01039376|Biological|Ofatumumab|Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.
16245966|NCT01039376|Other|Observation|Observation/Safety Evaluation
16245967|NCT01039363|Drug|Salvage reinduction chemotherapy including Gemtuzumab ozogamicin, Idarubicin and Cytarabine and Vorinostat|"Salvage reinduction therapy:
~Vorinostat 200mg BID po (D1-14) Gemtuzumab ozogamicin 3 mg/m2 once (D1) Idarubicin 12mg/m2 for 2 days (D2-3) Cytarabine 500mg/m2 bid IV for 5 days (D2-6)
~Maintenance:
~Once achieved CR, then Vorinostat 200mg BID po for 2 weeks, then 1 week's rest (1 cycle) for 11 cycles
~Vorinostat should be stopped at least 2 weeks ahead of starting of consolidation therapy.
~Gemtuzumab will be omitted in a consolidation schedule.
~Allogeneic hematopoietic stem cell transplantation (HSCT) can be performed if HLA-matched sibling or unrelated donor is available. Vorinostat will be stopped 2 weeks prior to starting of conditioning regimen for allogeneic HSCT."
16245968|NCT01039350|Drug|Darbepoetin alfa|Darbepoetin alfa will be initiated at a weekly (QW) subcutaneous dose of 300 mcg over 8 weeks.
16245969|NCT01039337|Other|Hip School|The hip school consists of one initial personal interview, three group sessions, and one follow-up personal interview. The hip school is a patient education programme which involves anatomy/physiology, epidemiology, disease progression and pain, advice on self-help and exercises.
16245970|NCT01039337|Other|Hip School and Manual Treatment|Hip school as above. Patients receive manual treatment twice a week for 6 weeks. Manual treatment consists of joint manipulation and muscle energy techniques to the articular and soft-tissue structures of the hip.
16245971|NCT01039337|Other|Minimal control intervention|As control group, an information leaflet is used with instructions to live as usual during the 6 weeks intervention period. The exercise sheet of the hip school is given to the patients with no further instruction.
16245972|NCT01039324|Other|Reports|Primary care event reports and patient letters
16245973|NCT01039324|Other|Reports and Notices|Primary care event reports, patient letters and care manager notices
16245974|NCT01039324|Other|Usual care|This is the study's control group
16245975|NCT01039311|Device|Optical Coherence Tomography|Obtain OCT images.
16245976|NCT01039298|Procedure|Fluorescence visualization device|The trial will randomize 200 patients - 100 in the control arm (using conventional white light approach).
16245977|NCT01039298|Procedure|Fluorescence visualization device|The trial will randomize 200 patients - 100 in the FV arm (using FV guided the surgery margin)
16245978|NCT01039285|Drug|Curosurf|2.5 ml/kg instilled in the trachea
16245979|NCT01039285|Other|Air|2.5ml/kg of Air will be instilled in the trachea
16245980|NCT01039259|Device|piercings of four different materials|randomly assigned sterile piercings are inserted for two weeks
16245981|NCT01039233|Drug|Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet|
16245982|NCT01039220|Biological|naso-pharyngeal swab|Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.
16245983|NCT01039207|Other|Laboratory Biomarker Analysis|Correlative studies
16245984|NCT01039207|Biological|Rilotumumab|Given IV
16245985|NCT01039194|Drug|galantamine|Capsule, Oral, 8 mg (ER), once daily, Days 1-7
16245986|NCT01039194|Drug|galantamine|Capsule, Oral, 16 mg (ER), once daily, Days 8-24
16245987|NCT01039194|Drug|BMS-708163|Capsule, Oral, 125 mg, once daily, Days 15-24
16245988|NCT01039181|Drug|Calcitriol|12 mcg Calcitriol will be given orally three times per week for 6 months. In this portion of the study, all patients will get the same dose of calcitriol along with the standard chemotherapy (5-fluorouracil-mitomycin C-leucovorin).
16245989|NCT01039168|Behavioral|Workplace dialogue|
16245990|NCT01039168|Other|Care as usual|
16245991|NCT01039155|Drug|Azacitidine|Given IV
16245992|NCT01039155|Other|Laboratory Biomarker Analysis|Correlative studies
16245993|NCT01039155|Drug|Oxaliplatin|Given IV
16245994|NCT01039155|Other|Pharmacological Study|Correlative studies
16245995|NCT01039142|Drug|Acitretin|capsule acitretin in dose of 25 mg, 35 mg or 50 mg/ day for 12 weeks or reduction in PASI score by 75% whichever is earlier
16245996|NCT01039129|Procedure|Endoscopic Cholecystectomy|An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.
16245997|NCT01039129|Procedure|Endoscopic Appendectomy|An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus
16245998|NCT01039129|Procedure|Endoscopic Peritoneoscopy|A diagnostic peritoneoscopy with or without biopsy for any indication
16245999|NCT01039116|Behavioral|High Intensity|High-intensity intervention, Experimental. Participating children were invited to attend a 2 week summer day camp at the beginning of each intervention year, and to attend a weekly, 2 hr interactive session for children. Activities provided hand-on experiences preparing and tasting healthy food alternatives, engaging in a range of physical activities and self-esteem boosting via activities that promoted communication and positive behavioral development.
16246000|NCT01039116|Behavioral|Low Intensity|Low-intensity intervention, Active comparator. Participants were provided with educational materials 4 times yearly.
16246001|NCT01039103|Drug|PEG-liposomal prednisolone sodium phosphate|PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
16246002|NCT01039103|Drug|Methylprednisolone|Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3
16246003|NCT01039090|Drug|Continuous Apomorphine infusion|Continuous Apomorphine infusion during 6 months
16246004|NCT01039090|Drug|Usual dopaminergic per os treatment|No specific change in the dopaminergic per os treatment
16246005|NCT01039077|Procedure|Laparoscopic gastric banding|Laparoscopic gastric banding for the treatment of morbid obesity.
16246006|NCT01039051|Behavioral|Diet and Lifestyle Intervention in Chinese Postpartum Women|For individual postpartum woman, we will set antepartum participatory training courses, provide specially prepared brochures and supporting VCD, set up a specialized counseling hotline and give individual bedside guidance after birth. For their family members, we will invite every postpartum woman's husband and mother to take part in workshops or seminars, making them know some basic knowledge of postpartum care, and persuading them to promote adoption of the diet and lifestyle we advocated by the postpartum woman. For community environment, we will put up posters about basic knowledge of postpartum care in the community bulletin boards for general population educating and mobilize community leaders and heads from and maternal and child health centers for maximum support.
16246007|NCT01039038|Radiation|curietherapy and radiotherapy|boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)
16246008|NCT01039025|Drug|Topotecan|After stem cells are collected, Topotecan 3.5 mg/m^2 intravenously given over 30 minutes on Days 1 - 5.
16246009|NCT01039025|Drug|Cyclophosphamide|After stem cells are collected, Cyclophosphamide 1 g/m^2/day intravenously given over 2 hours on Days 1 - 3.
16246010|NCT01039025|Drug|Melphalan|After stem cells are collected, Melphalan 70 mg/m^2/day intravenously given on Days 4 and 5.
16246011|NCT01039025|Other|Peripheral Blood Stem Cells|On Day 7, some or all of the stem cells will be reinfused.
16246059|NCT01038661|Drug|Cisplatin|"Formulation: concentrated solution for intravenous infusion (IV)
~Route(s) of administration: 1-3-hour IV"
16246012|NCT01039012|Other|Tai Chi|Participants randomized to the Tai Chi group select a Tai Chi school from a pre-screened list of community-based Tai Chi programs and enroll for 9 months. Participants are asked to attend classes twice a week for the first month and once a week for the remaining 8 months. They are also asked to practice at home, or attend more classes for 2-3 additional hours per week. While in the study they are also encouraged to follow the standard care as recommended by their physician.
16246013|NCT01039012|Other|Standard Care|Participant follow the standard care recommended by their physician.
16246014|NCT01038999|Biological|Peripheral blood biological tests|A group and B group will be evaluated three times, at baseline, then every 12 months during 3 years. In case of initiation or changing of antiretroviral therapy, patients will be evaluated once more. Control subjects will be only evaluated at baseline.
16246015|NCT01038986|Biological|CureXcell|The CureXcell™ dosage form consists of an aseptically-processed activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.
16246016|NCT01038960|Behavioral|Exercise training|3 months supervised interval training
16246017|NCT01038947|Biological|Uricase-PEG 20|Intramuscular injection of Uricase-PEG 20 without premedication
16246018|NCT01038934|Procedure|samples collected by buccal cytobrush|
16246019|NCT01038921|Drug|Melatonin|8 mg dose of Melatonin
16246020|NCT01038921|Drug|Placebo|Placebo
16246021|NCT01038908|Other|Isosulfan Blue (Patent Blue Dye V)|"Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
~Pre-incision: SLN is identified
~Inject blue dye into patient's arm
~Complete procedure (SLNB and/or ALND)"
16246022|NCT01038908|Other|Isosulfan Blue (Patent Blue Dye V)|"Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
~Pre-incision: SLN is not identified (No localization)
~Inject blue dye into breast (nothing in arm)
~i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)"
16246023|NCT01038895|Drug|Ramipril|tablet; 10 mg; od; 3 months
16246024|NCT01038895|Drug|Experimental|tablet; 300 mg; od; 3 months
16246025|NCT01038882|Drug|Midazolam|Sedation started by injecting a 4 ml drug bolus with midazolam (0.07-0.1 mg/kg dose). Supplemental doses of midazolam (2 mg) were administrated at an interval of >2 min to maintain conscious sedation
16246026|NCT01038882|Other|Physiological serum|We started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation
16246027|NCT01038869|Drug|Azelaic acid|Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.
16246028|NCT01038856|Drug|Erlotinib|Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib
16246029|NCT01038843|Drug|VA106483|"Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days.
~Placebo: as above"
16246030|NCT01038817|Drug|Duraphat|After prophylactic cleaning of the mouth and teeth, application of fluoride varnish according to the manufacturer's recommendations (up to 0.75 ml per application)
16246031|NCT01038804|Drug|YM155|intravenous infusion
16246032|NCT01038804|Drug|Docetaxel|intravenous infusion
16246033|NCT01038791|Device|heated humidification|temperature 35°
16246034|NCT01038791|Device|heat and moisture exchanger|single patient device
16246035|NCT01038791|Device|usual mechanical ventilation without humidification|mechanical ventilation with usual parameters
16246036|NCT01038778|Biological|Aldesleukin|Given IV
16246037|NCT01038778|Procedure|Computed Tomography|Undergo FDG-PET/CT
16246038|NCT01038778|Drug|Entinostat|Given PO
16246039|NCT01038778|Radiation|Fludeoxyglucose F-18|Undergo FDG-PET/CT
16246040|NCT01038778|Other|Laboratory Biomarker Analysis|Correlative studies
16246041|NCT01038778|Other|Pharmacological Study|Correlative studies
16246042|NCT01038778|Procedure|Positron Emission Tomography|Undergo FDG-PET/CT
16246043|NCT01038765|Behavioral|Mindfulness Based Cognitive Therapy|8-weeks group based intervention of mindfulness and cognitive behavioural techniques
16246044|NCT01038752|Drug|Suramin Drug:Docetaxel Drug: Carboplatin|Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
16246045|NCT01038752|Drug|Placebo Drug: Docetaxel Drug: Carboplatin|Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
16246046|NCT01038739|Drug|Mesalazine|3 g per day
16246047|NCT01038739|Drug|Mesalazine|1.5 g per day
16246048|NCT01038739|Drug|Placebo|0 g per day
16246049|NCT01038726|Other|Exercise Training|Aerobic exercise training program designed by the Cardiac Rehabilitation department
16246050|NCT01038726|Other|Cognitive Training|Based on cognitive training program Brain Fitness®
16246051|NCT01038726|Other|Flexibility Training|Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department
16246052|NCT01038726|Other|Educational Sessions|DVD-based educational programs on history, art, and literature
16246053|NCT01038713|Device|Biliary stent placement|Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
16246054|NCT01038687|Drug|A3309|A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets
16246055|NCT01038687|Drug|placebo|placebo
16246056|NCT01038674|Drug|anti-IL-20|Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
16246057|NCT01038674|Drug|placebo|Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
16246058|NCT01038661|Drug|Docetaxel|"Formulation: concentrated solution for intravenous infusion (IV)
~Route(s) of administration: 1-hour IV"
16246060|NCT01038661|Other|Best supportive care (BSC)|Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
16246061|NCT01038648|Drug|Sitagliptin|100mg/day
16246062|NCT01038648|Other|life style modification at base line|Advice on physical activity, diet and drug adherence.
16246063|NCT01038635|Drug|5-Azacytidine|75 mg/m^2 IV daily x 5 days on days 1 to 5.
16246064|NCT01038635|Drug|Lenalidomide|Starting dose 10 mg orally daily x 5 days on days 6 to 10.
16246065|NCT01038622|Drug|L-arginine|5-day L-arginine treatment
16246066|NCT01038622|Drug|placebo|5-day placebo treatment
16246067|NCT01038609|Drug|Hydrocodone/Acetaminophen Extended Release|
16246068|NCT01038609|Drug|Acetaminophen|
16246069|NCT01038609|Drug|Morphine Extended Release|
16246070|NCT01038609|Drug|Placebo|
16246071|NCT01038583|Drug|100 mg enteric-coated aspirin|100 mg enteric-coated aspirin, taken daily
16246072|NCT01038583|Drug|Placebo|100 mg enteric-coated placebo
16246073|NCT01038570|Drug|Syntocinon®/- Spray|3 sprays corresponding to 24 IU in each nostril
16246074|NCT01038570|Drug|Physiological serum (Sodium chloride)|Sodium chloride 0.9 % (0.3 ml) in each nostril
16246075|NCT01038557|Biological|RBC units|When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
16246076|NCT01038544|Procedure|Endoscopic Ultrasound (EUS)|Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy
16246077|NCT01038544|Procedure|Endobronchial Ultrasound (EBUS)|Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy
16246078|NCT01038531|Other|low-tidal-volume ventilation|goal tidal volume of 6 cc/kg ideal body weight
16246079|NCT01038531|Other|APRV|APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.
16246080|NCT01038505|Drug|Tacrolimus, Myfortic and Sirolimus|Immunosuppressive drugs
16246081|NCT01038492|Behavioral|p16 Methylation and Lung Cancer Education|"patients shown a presentation on p16 methylation and the development of lung cancer, asked to complete a questionnaire on items from presentation, desire to have p16 methylation test, views regarding their health and lung cancer, current smoking habits, and demographic details
~patients given a sputum cup which they are asked to spit into on three consecutive mornings and then return to the lab for processing
~a results letter is mailed to them and then followed up with a phone call at one month to discuss the results as well as any changes in their attitudes or smoking habits
~patients are called again at three months and asked about any changes in their attitudes or smoking habits."
16246082|NCT01038479|Dietary Supplement|Xylitol consumption|Mothers will eat 6 grams of xylitol per day
16246083|NCT01038479|Behavioral|Childsmile preventative programme|Mothers will receive the childsmile preventative programme
16246084|NCT01038453|Dietary Supplement|Cholecalciferol 35 µg per day|"Cholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day.
~In total 2 tablets per day per participant from Baseline to 16 weeks after delivery."
16246085|NCT01038453|Other|placebo tablet|placebo 2 tablet, once a day,
16246086|NCT01038453|Dietary Supplement|Cholecalciferol (Vitamin D3) 70 µg|"Cholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day.
~In total 2 tablets per day per participant from Baseline to 16 weeks after delivery."
16246087|NCT01038440|Dietary Supplement|Safflower Oil|One softgel consumed daily with food
16246088|NCT01038440|Dietary Supplement|EPA|Three different doses of EPA (0.5, 1.5 and 3.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.
16246089|NCT01038440|Dietary Supplement|SDA|Four different doses of SDA (0.5, 1.5, 3.0 and 6.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.
16246090|NCT01038427|Drug|Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)|Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
16246091|NCT01038427|Drug|Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray|Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
16246092|NCT01038427|Drug|Placebo|Placebo nasal spray administered once daily (4 actuations) for 14 days.
16246093|NCT01038414|Behavioral|Extended Duration Behavioral Smoking Cessation Counseling|Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling
16246094|NCT01038401|Procedure|GI endoscopy and GALT biopsies|This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT)
16246095|NCT01038401|Biological|A sample of venous blood will also be collected|These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
16246096|NCT01038388|Drug|Bortezomib|1.3mg/m² given IV or subcutaneously
16246097|NCT01038388|Drug|Lenalidomide|25 mg given PO
16246098|NCT01038388|Drug|Dexamethasone|20 mg given PO
16246099|NCT01038388|Drug|Vorinostat|100, 200, or 300 mg given PO
16246100|NCT01038375|Behavioral|lifestyle counseling, home blood pressure monitoring|monthly telephone counseling over 6 months for intervention group no health provider initiated contact for control group
16246101|NCT01038362|Other|NCEP Step 1 diet plus Almonds|NCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks
16246102|NCT01038362|Other|No Almonds|NCEP Step 1 diet without almonds
16246103|NCT01038349|Other|Avise PG - Diagnostic test|Eligible patients will receive an Avise PG test
16246104|NCT01038336|Behavioral|Multimedia Hearing Loss Prevention Program|Interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
16246105|NCT01038336|Behavioral|Hearing Conservation Brochure|Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
16246194|NCT01037582|Drug|placebo|Subjects will be randomized to receive a single dose of placebo.
16246106|NCT01038323|Other|CBT and milnacipran|"Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week starter pack. Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study."
16246107|NCT01038323|Behavioral|CBT with a placebo|"Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of a placebo. Dosing for the placebo begins with a one week starter pack. Dosage: 12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study."
16246108|NCT01038323|Drug|Educational with milnacipran|"Participants will receive a series of eight telephone sessions of fibromyalgia related education along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week starter pack. Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study."
16246109|NCT01038297|Drug|EXC 001|Intradermal injections of EXC 001 and placebo given on various schedules.
16246110|NCT01038297|Drug|Placebo|Intradermal injections of EXC 001 and placebo given on various schedules.
16246111|NCT01038284|Behavioral|Patient education|Pharmaceutical care of patients with PAH
16246112|NCT01038284|Other|Data collection|Clinical and biological data, treatment, medication errors and ADEs
16246113|NCT01038271|Other|Standard Palliative Care Group|Participant is referred to the Palliative Care Team at any time.
16246114|NCT01038271|Other|Integrated Palliative Care Intervention|Participant meets with the Palliative Care Team within 3 weeks of being randomized
16246115|NCT01038258|Procedure|PET scan after course 1 and surgery after 8 courses|PET scan and surgery
16246116|NCT01038206|Behavioral|Familias Unidas|There will be 8 group sessions and 4 family visits. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents. During family visits, facilitators assist families in practicing skills and restructuring family interactions. The parent group sessions focus on parental investment in the adolescent's worlds (e.g., peer and school worlds), family communication, family support, behavior management/positive parenting, parental monitoring, adolescent substance use, and adolescent unsafe sex and HIV. Consistent with our prior Familias Unidas efficacy studies, all parent group sessions and all family visits will be conducted in Spanish and will take place in the evenings and on Saturdays at the school or at a community site that is preferred by the families.
16246117|NCT01038193|Other|Cognitive assessment|Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.
16246118|NCT01038167|Drug|telaprevir|Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
16246119|NCT01038167|Drug|telaprevir|Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2
16246120|NCT01038167|Drug|cyclosporine|Solution, Oral, 100mg, Day 1 of Period 1
16246121|NCT01038167|Drug|cyclosporine|Solution, Oral, 10mg, Day 1 and Day 8 of Period 2
16246122|NCT01038167|Drug|tacrolimus|Capsule, Oral, 2mg, Day 1 of Period 1
16246123|NCT01038167|Drug|tacrolimus|Capsule, Oral, 0.5mg, Day 8 of Period 2
16246124|NCT01038154|Drug|Pravastatin|Receive one tablet of 40 mg of pravastatin, orally every 24 hours (at breakfast) for 2 years.
16246125|NCT01038141|Procedure|Surgery for advanced haemorrhoidal disease|Milligan Morgan vs Recto Anal Repair
16246126|NCT01038128|Drug|Memantine|Drug: Memantine, 10-40 mg daily
16246127|NCT01038115|Procedure|Atrial fibrillation ablation|Comparison of three different techniques for pulmonary vein isolation
16246128|NCT01038102|Other|PUFA Diet|Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).
16246129|NCT01038102|Other|SFA diet|Diet high in saturated fat (15E%)
16246130|NCT01038089|Dietary Supplement|Resveratrol|Resveratrol
16246131|NCT01038076|Behavioral|MedCHEC Tablet Computer & Adherence Care|Patients answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates patient and provider reports. Patients may be referred to an Adherence Care Manager on the basis of the reports.
16246132|NCT01038063|Drug|Artemether-lumefantrine combination|
16246133|NCT01038050|Drug|Ginkgo Biloba Extract (GBE)|Ginkgo Biloba Extract 40 mg 1# tid per day for 3 months(90 days)
16246134|NCT01038037|Drug|Carboplatin|i.v. day 1: AUC 5 x (GFR + 25) mg q3w
16246135|NCT01038037|Drug|Vinorelbine|i.v. day 1: 30 mg/m2 q3w Orally day 8: 60 mg/m2 q3w
16246136|NCT01038037|Drug|panitumumab|i.v. day 1: 9 mg/kg q3w
16246137|NCT01038024|Dietary Supplement|1 tablet composed of antioxidants and minerals|1 tablet daily
16246138|NCT01038011|Drug|drug treatment|
16246139|NCT01037998|Drug|UFUR and Iressa|Iressa 250 mg daily plus UFUR 1# bid
16246140|NCT01037985|Drug|EXC 001|Multiple intradermal injections of EXC 001 and placebo
16246141|NCT01037985|Drug|Placebo|Multiple intradermal injections of EXC 001 and placebo
16246142|NCT01037972|Behavioral|Conventional physiotherapy|3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity.
16246143|NCT01037972|Behavioral|Whole body vibration|3 times weekly 30 minutes of exercises on a whole body vibration device to strengthen muscular strength and improve muscular balance in the lower extremity.
16246144|NCT01037959|Drug|Norfloxacin|400 mg/day (per os) for 6 months
16246145|NCT01037959|Drug|Placebo|1 pill/day (per os) for 6 months
16246146|NCT01037946|Behavioral|Cognitive behavioral sessions|Behavioral: Cognitive-behavioral, small group format sessions delivered in Thai to People Living with HIV and their caregivers once a week for 13 weeks (n=13 sessions).
16246147|NCT01037933|Other|Humor intervention|"A 45-minute humorous DVD (Bananas Bunch) using a portable DVD player."
16246148|NCT01037933|Other|Non-humor intervention (distraction)|"A 45-minute non-humorous DVD (The A to Z of Steam Railways) using a portable DVD player"
16246149|NCT01037920|Behavioral|Self-affirmation exercise|The intervention exercise asks subjects to reflect on a list of 11 personal values and to circle 2 or 3 items that are most important to them. Subjects are asked then to write a few sentences to describe why they are important.
16246195|NCT01037582|Drug|NN9924 (s.c.)|As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
16246150|NCT01037920|Behavioral|Control|The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.
16246151|NCT01037907|Drug|Pleneva TM BGC20-0134|Placebo or 5 g dose
16246152|NCT01037907|Drug|Placebo|Placebo or 5 g dose
16246153|NCT01037894|Procedure|Acupuncture|Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
16246154|NCT01037894|Procedure|Conventional rehabilitation|In-patient physiotherapy, occupational therapy and speech therapy.
16246155|NCT01037881|Drug|LEO 29102|comparison of different dosages of drug
16246156|NCT01037881|Drug|Elidel®|comparison
16246157|NCT01037868|Other|Supportive SMS text messages|Patients in the intervention group would receive twice daily supportive SMS text messages for 3 months from the treating team which would encourage/motivate them to refrain from drinking alcohol and comply with their medication. They would also receive a fortnightly phone call from an unblinded member of the research/treating team which would only serve the purpose of confirming that they still uses the mobile phone and receive the text messages.
16246158|NCT01037855|Other|Non-intervention observational study|Non-intervention observational study
16246159|NCT01037842|Drug|Mitiglinide|"mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
~for 16 weeks"
16246160|NCT01037842|Drug|Placebo|placebo three times a day added to metformin 500 mg three times a day for 16 weeks
16246161|NCT01037829|Other|Non-intervention observational study|Non-intervention observational study
16246162|NCT01037816|Drug|FS-67 Patch|One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
16246163|NCT01037816|Other|Placebo Patch|One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
16246164|NCT01037790|Drug|PD-0332991|Given orally, 125 mg QD on a 21-day
16246165|NCT01037764|Procedure|alloHCT|"[ alloHCT arm ] Bu-Cy conditioning; Busulfan (Bu) 3.2 mg/kg*/day iv daily on days -7 and -4. Cyclophosphamide (Cy) 60 mg/kg* in D5W 200 mL iv over 1-2 hours daily on days -3 and -2.
~BuFluATG conditioning; Bu 3.2 mg/kg*/day iv daily on days -7 and -6. Fludarabine (Flu) 30 mg/m2/day in D5W 100 ml iv over 30 minutes starting at 4 pm daily on days -7, -6, -5, -4, -3, and -2.
~Anti-thymocyte globulin (ATG, Thymoglobulin, Genzyme Transplant, Cambridge, MA, USA) 1.5 mg/kg/day (for HLA-matched sibling HCT) or 3.0 mg/kg/day (for HLA-matched unrelated donor HCT or HLA-mismatched familial donor HCT) in N/S 500-800 ml (less than 4 mg/ml) iv over 4 hours starting at 8 am daily on days , -3, -2 and -1."
16246166|NCT01037751|Behavioral|Interview|1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.
16246167|NCT01037751|Behavioral|Survey|Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.
16246168|NCT01037738|Procedure|ACL reconstructive surgery and ACS/ Orthokin application|ACL reconstructive surgery and ACS/ Orthokin or Placebo intraarticular application on Day 0,1,6 and 10 postoperatively, regarding the Arm
16246169|NCT01037725|Drug|AZD5847|"Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1.
~Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal"
16246170|NCT01037725|Drug|Placebo to AZD5847|In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1
16246171|NCT01037712|Drug|Valacyclovir (ZELITREX)|2g, 8g/day, 4 a day 23 weeks maximum.
16246172|NCT01037712|Drug|Placebo|placebo
16246173|NCT01037699|Drug|rFSH: Follicle Stimulating Hormone|
16246174|NCT01037699|Drug|rFSH: Follicle Stimulating Hormone|
16246175|NCT01037699|Drug|rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)|
16246176|NCT01037699|Drug|rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)|
16246177|NCT01037686|Radiation|Injection of 15mCi of Tc-ECD and scanning by SPECT camera|All subjects (PD patients with or without DBS and healthy controls) will be injected with 15mCi of Tc-ECD and afterwards will be scanned by an Irix SPECT camera.
16246178|NCT01037686|Behavioral|Semantic verbal fluency task performance|All Subjects (PD patients with or without DBS and healthy controls) before one of the two scans will perform the semantic verbal fluency task during the Tc-ECD uptake for 9 minutes. Before the other scan subjects will be at rest.
16246179|NCT01037686|Device|Turning off the stimulator|For PD patients treated with DBS, the neurologist will turn off the stimulator after the injection of Tc-ECD for ten minutes and then turn it back on.
16246180|NCT01037673|Procedure|Exercise program|A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
16246181|NCT01037673|Procedure|Movement exercises|A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.
16246182|NCT01037660|Drug|Metformin|Metformin 1 gram per day
16246183|NCT01037647|Other|Hyperinsulinemic euglycemic glucose clamp|Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).
16246184|NCT01037634|Drug|Oseltamivir|3 mg/kg given orally for 5 days for seasonal influenza, 7 days for 2009 H1N1 influenza (in Vietnam only), or 10 days for avian influenza, for children whose renal function is greater than or equal to 30 mL/min/1.73m2
16246185|NCT01037621|Drug|Valacyclovir|Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
16246186|NCT01037608|Drug|Sativex(Registered Trademark)|
16246187|NCT01037608|Drug|THC|
16246188|NCT01037595|Drug|turmeric|turmeric 500 md tid orally for 8 weeks
16246189|NCT01037595|Drug|placebo|placebo 3 time orally for 8 weeks
16246190|NCT01037595|Drug|turmeric|500 mg tid orally for 8 weeks
16246191|NCT01037582|Drug|NN9924 (oral)|Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.
16246192|NCT01037582|Drug|placebo|Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
16246193|NCT01037582|Drug|NN9924 (oral)|Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
16246196|NCT01037582|Drug|NN9924 (i.v.)|As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
16246197|NCT01037556|Drug|PR104|Nine pre-defined dose levels for specific subsets of subjects will be administered by IV (in the vein). PR104 will be administered initially as induction therapy followed by administration as consolidation therapy, as is typical of established treatment regimens in AML.
16246198|NCT01037543|Drug|HM10460A or placebo or Neulasta|Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
16246199|NCT01037530|Drug|Ramipril|5 mg/day for 2 weeks then 10 mg/day for 22 weeks
16246200|NCT01037517|Drug|Plerixafor|Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day
16246201|NCT01037517|Other|Observation: Nonintervention|Nonintervention group, no drug will be given, observation only
16246202|NCT01037504|Drug|AZD5423|Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
16246203|NCT01037504|Drug|Placebo|Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.
16246204|NCT01037491|Drug|rabeprazole plus aspirin versus rabeprazole plus clopidogrel|The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.
16246205|NCT01037478|Drug|Resminostat (4SC-201)|oral administration
16246206|NCT01037465|Drug|N-acetylcysteine|N-acetylcysteine
16246207|NCT01037465|Drug|Placebo|Placebo
16246208|NCT01037452|Drug|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg|Tablet
16246209|NCT01037452|Drug|Lansoprazole|Tablet
16246210|NCT01037452|Drug|Calcium carbonate/magnesium hydroxide|Tablet
16246211|NCT01037452|Drug|Placebo|Tablet
16246212|NCT01037439|Device|Adaptive Servo-controlled Ventilation (ASV)|Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed
16246213|NCT01037426|Other|Fill out Questionnaire|"Questionnaire at time of Implantation and 12 months after pacemaker implantation to collect
~History of falls and fractures during the 12 months before pacemaker implantation
~Risk markers for falls based on FRAX risk calculator (age, gender, weight, height, history of previous fracture, family history of hip fracture, current smoking habits, glucocorticosteroid intake, rheumatoid arthritis, secondary osteoporosis, alcohol intake)
~History of falls and fractures during the 12 months after pacemaker implantation
~Medical and Arrhythmia History
~Cardiovascular Events
~Cardiovascular Medication
~Device programming information"
16246214|NCT01037413|Drug|EXC 001|Multiple intradermal injections of EXC 001 and placebo
16246215|NCT01037413|Drug|Placebo|Multiple intradermal injections of EXC 001 and placebo
16246216|NCT01037387|Drug|Control|Current treatment according to the ATS/ERS guidelines
16246217|NCT01037387|Device|NIMV group|Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
16246218|NCT01037374|Other|Preoperative assessment form|(based on the american society of anesthesiologists)components of the form include: neck measurements; neck mobility; mallampati; wilson's test; pre-existing conditions; and predictions of difficult mask ventilation, supraglottic airway, laryngoscopy, intubation, and surgical airway.
16246219|NCT01037348|Drug|ranibizumab 0.5mg|
16246220|NCT01037335|Drug|morphine|Group 1 (control group) was given 10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly. Group 2 (intramuscular morphine) was given 10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly. Group 3 (donor site morphine) was given 5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.
16246221|NCT01037322|Drug|cannabidiol|cannabidiol given in olive oil drops, 5 mg twice daily
16246222|NCT01037322|Drug|placebo in drops|olive oil containing no drug given in drops twice daily
16246223|NCT01037309|Drug|PRO044 SC|Subcutaneous injection, once a week, for five weeks
16246224|NCT01037309|Drug|PRO044 IV|Intravenous injection, once a week, for five weeks
16246225|NCT01037296|Procedure|catheter ablation|ablation procedure performed with Hansen robotic navigation system
16246226|NCT01037296|Procedure|catheter ablation|Ablation will be performed as normal treatment
16246227|NCT01037283|Behavioral|Interpersonal and Social Rhythm Therapy|Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.
16246228|NCT01037244|Drug|Udenafil|Tablets via oral administration before an attempt at sexual intercourse.
16246229|NCT01037244|Drug|Placebo|Tablets via oral administration before an attempt at sexual intercourse.
16246230|NCT01037231|Biological|Oxalobacter formigenes|NLT (not less than) 10^7 CFU oxalobacter formigenes twice daily for 24 weeks
16246231|NCT01037231|Drug|Placebo|placebo
16246232|NCT01037218|Drug|Udenafil|Tablets via oral administration before an attempt at sexual intercourse.
16246233|NCT01037218|Drug|Placebo|Tablets via oral administration before an attempt at sexual intercourse.
16246234|NCT01037205|Drug|DAS181 dry powder, formulation F02|10 mg delivered dose DAS181 in clear HPMC #3 Capsules
16246235|NCT01037205|Drug|Respitose ML006 (DMV-Fonterra)|Lactose monohydrate
16246236|NCT01037192|Drug|vancomycin|vancomycin 30 mg/kg intravenous administered once daily
16246237|NCT01037192|Drug|vancomycin|vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
16246238|NCT01037179|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%|
16246239|NCT01037166|Drug|Entecavir|Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
16246240|NCT01037140|Drug|Cholecalciferol|oral cholecalciferol tablets of 175 micrograms daily for 6 months
16246241|NCT01037140|Drug|placebo|oral placebo tablets similar to active comparator
16246242|NCT01037127|Drug|GSK1120212|Daily oral dosing
16246243|NCT01037114|Procedure|Blood sampling|Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).
16246244|NCT01037114|Biological|Engerix-B|Engerix-B will be administered to subjects who are not seroprotected against hepatitis B.
16246245|NCT01037114|Biological|Havrix|Havrix will be administered to subjects who are seronegative for anti-HAV antibodies.
16246247|NCT01037101|Behavioral|Virtual Reality Exposure Therapy|Three hours of exposure therapy using a virtual reality system
16246248|NCT01037101|Drug|D-Cycloserine|50 mg of DCS administered 30 minutes before the session
16246249|NCT01037101|Drug|Placebo|50 mg placebo administered 30 minutes before the session
16246250|NCT01037088|Drug|Mild dose cannabis|3.53% THC by weight
16246251|NCT01037088|Drug|Low dose cannabis|1.29% THC by weight
16246252|NCT01037088|Drug|Cannabis|0.00% THC by weight
16246253|NCT01037062|Drug|Entecavir|Tablet, P.O. 0.5, 1 mg, once daily
16246254|NCT01037049|Other|Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy|
16246255|NCT01037036|Drug|Latanoprost Punctal Plug Delivery System|To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
16246256|NCT01037036|Drug|Xalatan|Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
16246257|NCT01037023|Drug|Topotecan|patients administrated Topotecan according to the prescribing information
16246258|NCT01036932|Drug|Granulocyte Colony Stimulating Factor|Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
16246259|NCT01036932|Drug|Normal Saline|dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
16246260|NCT01036893|Drug|prucalopride|prucalopride 2 mg oral dosing o.d. for 6 days
16246261|NCT01036854|Drug|EUR-1025|orally, 24 mg, daily for 6 days
16246262|NCT01036854|Drug|EUR-1025|orally, 8 mg, twice daily over 6 consecutive days
16246263|NCT01036854|Drug|EUR-1025|orally, 8 mg, three times a day over 6 consecutive days
16246264|NCT01036854|Drug|EUR-1025|orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
16246265|NCT01036841|Drug|desmopressin tablet|Administration of desmopressine tablet
16246266|NCT01036841|Drug|desmopressin MELT formulation|Administration of desmopressine MELT formulation
16246267|NCT01036802|Drug|Warfarin|Patients on the active treatment arm will receive warfarin to achieve a target international normalized ratio of between 2 and 3
16246268|NCT01036802|Drug|Placebo|
16246269|NCT01036724|Device|Cardiac Mapping|Generating a cardiac map using the study device (CARTO 3) compared to the control device (NAVX[TM]) and measuring the amount of radiation exposure duration for each.
16246270|NCT01036659|Drug|ecallantide - Kallikrein inhibitor that blocks the production of bradykinin|subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.
16246271|NCT01036633|Device|Infrared Thermometer|The infrared thermometer will be used to grade the severity of oral mucositis in patients undergoing antineoplastic chemotherapy for multiple myeloma. The photothermal camera will be used to take intraoral digital images of the mouth.
16246272|NCT01036594|Drug|Ketoconazole|200mg during first week of study (run-in phase), then 400mg po tid
16246273|NCT01036594|Drug|Hydrocortisone|"Hydrocortisone 20mg po qam and 10mg po qpm
~If participant has ≥30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If participant has <30% PSA decline, patient goes off study."
16246274|NCT01036594|Drug|Dexamethasone|"Dexamethasone 0.5mg po bid
~If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression (by RECIST criteria OR by PSAWG criteria) is documented."
16246277|NCT01036529|Device|Precision Spinal Cord Stimulator|Programming settings will be specific to the individual needs in accordance with the labeling
16246278|NCT01036529|Procedure|Back Surgery|Different types of back surgery may be performed
16246279|NCT01036490|Other|Exercise|Exercise training for 12 weeks followed by home exercise for 40 weeks
16246280|NCT01036438|Device|Mepilex Ag|Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
16246281|NCT01036438|Device|Mepilex without Ag|Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
16246282|NCT01036412|Drug|1% Chlorhexidine Gluconate Gel|Following two 2.5 ml 5-minute applications performed in clinic on Day 1, 2 x 5.0 ml syringes of chlorhexidine gel self-administered for one 5-minute application using the custom-made carriers carriers on week 2 (12-14 days from baseline visit study drug administration) and week 4 (12-14 days from Week 2 study drug administration).
16246283|NCT01036412|Behavioral|Surveys|M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire, in addition to a 2nd subjective, study-specific questionnaire administered during visit taking about 5 minutes to complete each assessment.
16246284|NCT01036399|Drug|Lenalidomide|Oral Lenalidomide is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.
16246285|NCT01036360|Other|metabolic chamber|20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each
16246286|NCT01036321|Drug|Purified isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily
16246287|NCT01036321|Drug|Methyl cellulose blend|Placebo - Take 2 capsules daily
16246288|NCT01036308|Dietary Supplement|pure fibre-product|The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
16246289|NCT01036308|Dietary Supplement|reference fibre|The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
16246290|NCT01036282|Behavioral|Computerized Cognitive Skill Training|Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
16246291|NCT01036282|Behavioral|CRT and Social Cognition|Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.
16246292|NCT01036243|Dietary Supplement|test formula 1|hydrolyzed formula with probiotics
16246293|NCT01036243|Dietary Supplement|test formula 2|acidified hydrolyzed formula
16246294|NCT01036243|Dietary Supplement|test formula 3|hydrolyzed formula without probiotics
16246295|NCT01036243|Dietary Supplement|reference formula|standard infant formula
16246296|NCT01036165|Device|RebiSmart™|The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
16246297|NCT01036139|Drug|BF2.649 (pitolisant)|1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
16246298|NCT01036113|Drug|EZN-2208|EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
16246299|NCT01036087|Drug|Panitumumab|2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
16246300|NCT01036087|Drug|Nab-paclitaxel|100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
16246301|NCT01036087|Drug|Carboplatin|AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
16246302|NCT01036087|Drug|5-Fluorouracil|500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
16246303|NCT01036087|Drug|Epirubicin|100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
16246304|NCT01036087|Drug|Cyclophosphamide|500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
16246305|NCT01036061|Drug|GSK618334 Low Dose|GSK618334 low dose
16246306|NCT01036061|Drug|GSK618334 PET subjects|PET subjects
16246307|NCT01036061|Drug|GSK618334 Medium Dose|Medium Dose
16246308|NCT01036061|Drug|GSK618334 High Dose|GSK618334 High Dose
16246309|NCT01036048|Device|drug eluting stent|pts with cabg disease treated with drug eluting stent
16246310|NCT01036048|Device|bare metal stent|pts with cabg disease treated with bare metal stent
16246311|NCT01036035|Drug|Tolterodine|Comparison of different dosages of drug
16246312|NCT01036035|Drug|Pilocarpine|Comparison of different dosages of drug
16246313|NCT01036035|Drug|THVD-201|Comparison of different dosages of drug
16246314|NCT01036035|Drug|THVD-201|Comparison of different dosages of drug
16246315|NCT01036035|Drug|placebo capsule|Comparison of different dosages of drug
16246316|NCT01036022|Drug|GSK1399686|Each dose level of GSK1399686 will be subsequently tested in a cohort of approximately 20 patients, who will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.
16246317|NCT01036009|Other|Withdrawal of immunosuppression and donor lymphocyte infusion|Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
16246318|NCT01035983|Drug|Frovatriptan 2.5 mg|
16246319|NCT01035944|Device|HemCon Dressings and HemCon ChitoGauze; chitosan-based.|Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
16246320|NCT01035944|Device|Gauze and saline dressings.|Control for both settings will be gauze and saline dressings.
16246321|NCT01035905|Device|Nelfilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16246322|NCT01035905|Device|Narafilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16246323|NCT01035879|Drug|MBX-2982|tablets and capsule once daily
16246324|NCT01035879|Drug|MBX-2982|tablets and capsule once daily
16246325|NCT01035879|Drug|MBX-2982|tablets and capsule once daily
16246326|NCT01035879|Drug|Sitagliptin|tablets and capsule once daily
16246327|NCT01035879|Drug|placebo|tablets and capsule once daily
16246328|NCT01035853|Drug|Colistin|Sino-Nasal inhalation, approximately 1 ml / day in each nostril
16246329|NCT01035801|Drug|IN-105|Prandial Oral Insulin
16246330|NCT01035801|Drug|Insulin Lispro Injection|Insulin Lispro Injection
16246331|NCT01035788|Behavioral|Mindfulness Based Cognitive Behavioral Conjoint Therapy|This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses.
16246332|NCT01035788|Behavioral|CBCT for PTSD - Communication Skills|This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD.
16246333|NCT01035775|Procedure|Inspection during insertion|The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
16246334|NCT01035775|Procedure|Inspection during withdrawal|The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum. The instrument will be inserted to the cecum without deliberate inspection.
16246335|NCT01035749|Biological|GSK Biologicals' Influenza investigational vaccine GSK2340274A|One or two doses administered intramuscularly
16246336|NCT01035749|Biological|GSK Biologicals' Influenza investigational vaccine GSK2340273A|Two doses intramuscularly
16246337|NCT01035749|Biological|Placebo (saline)|One dose intramuscularly
16246338|NCT01035671|Drug|alpha-tocopherolquinone (A0001)|28 days of low dose (1.0 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.
16246506|NCT01034254|Biological|saline placebo|Vaccination of pregnant women with saline placebo.
16246339|NCT01035671|Drug|alpha-tocopherolquinone (A0001)|28 days of high dose (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.
16246340|NCT01035671|Drug|placebo|28 days of placebo oral capsules. Treatment taken twice daily with meals.
16246343|NCT01035645|Drug|GSK1070806|"The study drug, GSK1070806, is a humanised monoclonal antibody. Antibodies are proteins that are made by white blood cells during an immune reaction. They circulate in the blood and attach to foreign proteins called antigens in order to destroy or neutralise them.
~Humanised monoclonal antibodies are a type of protein that is genetically engineered to resemble a human protein (humanised). GSK1070806 is designed to block a specific protein that exists in the body called Interleukin-18. Interleukin-18 works within the immune system, i.e. the body's defence system, which helps protect it from disease, bacteria and viruses. Interleukin-18 activates the immune system to fight infections and may also occasionally cause inflammation."
16246344|NCT01035619|Drug|moxidectin|Single Dose Moxidectin 4 mg
16246345|NCT01035606|Behavioral|training in goal-directed attention regulation|training in goal-directed attention regulation
16246346|NCT01035606|Behavioral|brain health education|brain health education workshops
16246347|NCT01035606|Behavioral|computer-assisted training in goal-directed attention regulation|computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
16246348|NCT01035593|Procedure|plasmapheresis and IVIG|Plasmapheresis with either 5% human albumin or FFP replacement, plus IVIG 100mg/kg IV after each PP session, every other day x 5 treatments
16246349|NCT01035593|Drug|recombinant C1 inhibitor|100units/kg IV for seven consecutive days (once daily on PP/IVIG days, twice daily on non-PP/IVIG days).
16246350|NCT01035580|Drug|Curcumin|Curcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg
16246351|NCT01035580|Drug|curcumin|all patients received the drug
16246352|NCT01035567|Procedure|Hybrid revascularization|First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery
16246353|NCT01035567|Procedure|Coronary Artery Bypass Grafting|Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
16246354|NCT01035554|Other|Self-Paced Programmed Instruction (SPPI)|If participants are assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials (PM) from the National Institutes of Health.
16246355|NCT01035554|Other|Home Blood Pressure Monitor|The home blood pressure monitor will allow the participant to measure their blood pressure anytime and anywhere precisely, quickly and easily on their upper arm.
16246356|NCT01035554|Other|Usual Care|Standard care
16246357|NCT01035554|Other|Printed Materials|National Institutes of Health Printed Materials on hypertension
16246358|NCT01035541|Device|PiCCO® Monitoring|Fluid and vasopressor management according to PiCCO measruements
16246359|NCT01035528|Drug|insulin glargine|antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
16246360|NCT01035528|Drug|metformin|use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
16246361|NCT01035515|Drug|Placebo|Single dose oral capsule placebo comparator
16246362|NCT01035515|Drug|BIIB014 50mg|Single dose oral capsule 50mg BIIB014
16246363|NCT01035515|Drug|BIIB014 100mg|Single dose oral capsule 100mg BIIB014
16246364|NCT01035502|Drug|Elacytarabine plus idarubicin|"Elacytarabine 1000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.
~Idarubicin will be administered IV at a fixed dose of 12 mg/ m2/d IV on d 1-3 q3w.
~It is intended that patients receive remission-induction treatment either as two combination courses, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d or one combination course, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d followed by one course elacytarabine 2000 mg/m2/d single therapy."
16246365|NCT01035489|Device|CRT in heart failure; Right ventricular apex v.s. high posterior septum|RV lead is randomized to either apex or high posterior septum
16246366|NCT01035489|Device|CRT in heart failure; Right ventricular apex v.s. high posterior septum|RV lead is randomized to either apex or high posterior septum
16246367|NCT01035476|Behavioral|Data Card Report|Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
16246368|NCT01035463|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous hematopoietic stem cell transplant
16246369|NCT01035463|Drug|Carmustine|Given IV
16246370|NCT01035463|Drug|Cytarabine|Given IV
16246371|NCT01035463|Drug|Etoposide|Given IV
16246372|NCT01035463|Drug|Lenalidomide|Given PO
16246373|NCT01035463|Drug|Melphalan|Given IV
16246374|NCT01035463|Biological|Rituximab|Given IV
16246375|NCT01035450|Device|Everolimus-eluting stent|Everolimus-eluting stent
16246376|NCT01035450|Device|Sirolimus-eluting stent|Sirolimus-eluting stent
16246377|NCT01035437|Drug|HPPH 2-1[1-hexyloxyethyl]-2-devinyl Pyropheophorbide-a)|HPPH in D5W, 4.0 mg/m2 infused over 1 hour
16246378|NCT01035411|Drug|AZD9668|2 x 30 mg batch DLE494
16246379|NCT01035411|Drug|AZD9668|2 x 30 mg batch DLF497
16246380|NCT01035411|Drug|AZD9668|2 x 30 mg tablet variant 1
16246381|NCT01035385|Drug|FOFLOX4|FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles
16246382|NCT01035372|Dietary Supplement|dried plum powder|subjects will have 25% of their diet substituted by dried plum powder
16246383|NCT01035359|Procedure|External fixation|Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)
16246554|NCT01033864|Drug|MMF|1 g per day b.i.d. p.o. for at least 1 month
16246384|NCT01035359|Procedure|Volar plate|Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.
16246385|NCT01035346|Drug|Ibuprofen|Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
16246386|NCT01035346|Drug|Placebo|Single dose of a placebo
16246387|NCT01035333|Drug|Orlistat|60mg capsule three times a day for up to 6 months
16246388|NCT01035320|Drug|Ezetimibe|After a placebo only run-in period patients (two groups) are treated with simvastatin + ezetimibe and simvastatin + placebo in a cross-over trial. Ezetimibe effects on top of simvastatin will be evaluated as the primary aim; simvastatin effects compared to run-in on placebo will be evaluated as a secondary aim.
16246389|NCT01035307|Genetic|gene expression analysis|
16246390|NCT01035307|Genetic|microarray analysis|
16246391|NCT01035307|Genetic|proteomic profiling|
16246392|NCT01035307|Other|laboratory biomarker analysis|
16246393|NCT01035294|Behavioral|mindfulness based intervention (MBI)|Eight, phone delivered, individual mindfulness sessions. Each training session will last 30 minutes (20 minutes for intervention + an additional 10 minutes for questions, answers, and for scheduling the next intervention. Patients will also receive instructions to practice at home every day, at least once a day, for at least 15 minutes. An audio CD containing guided mindfulness exercises will be given to the patient at the beginning of the study, to guide them during their home practice. The CD consists of sequences of different mindfulness techniques, consistent with the techniques learned during each session with the instructor. Each patient will record the minutes of mindfulness practice in a diary to be kept daily.
16246394|NCT01035294|Behavioral|usual care|The UC group will be offered the standard care planned by the hospital, which includes the routine care provided by the electrophysiology team and other health care professionals that the patient may see over the course of the ICD experience. All patients receive a number of printed education materials and participate to support meetings for ICD patients four times a year. Being part of the standard care offered at UMass Memorial Medical Center, these meetings are offered to all patients regardless of their assignment (thus including patients assigned to the MBI arm).
16246395|NCT01035281|Drug|Nabilone, flexible dosing|nabilone at 0.5 - 4 mg/day
16246396|NCT01035268|Procedure|fatty tissue transfer|It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.
16246397|NCT01035255|Drug|LCZ696 200 mg BID|LCZ696 200 mg BID
16246398|NCT01035255|Drug|Enalapril 10 mg BID|Enalapril 10 mg BID
16246399|NCT01035242|Behavioral|"association splitting"|"Association splitting is a cognitive intervention which aims at reducing obsessive thoughts. Association splitting is based on the so called fan effect (Anderson, 1974) and aims at reducing the strength of obsessive cognitions. For this purpose core intrusive thoughts are identified with the patient (such as cancer - illness) and the patient is encouraged to find non-OCD associations that are (semantically or phonologically) related to the OCD cognition (such as cancer - (zodiac) sign, cancer - great crab). To strengthen the novel connections, these associations are elaborated by the use of pictures, music, or smells. By enhancing OC-unrelated associations it is assumed that the influence of OC-related concepts is weakened."
16246400|NCT01035242|Behavioral|cognitive remediation|Computerized cognitive remediation (CogPack training). A fixed sequence is administered, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The difficulty level for each patient is adapted automatically depending on to the subject's performance on prior exercises. At the end of each session, the patient receives individual feedback on his or her performance. To match with association splitting, six sessions are administered. Each session lasts approximately 45-60 minutes.
16246401|NCT01035229|Drug|Everolimus|Everolimus (labeled as RAD001) was formulated as tablets of 2.5 mg strength and blisterpacked in units of 10 tablets.
16246402|NCT01035229|Drug|Everolimus Placebo|Everolimus Placebo matched to the everolimus 2.5 mg tablet strength was blister-packed in units of 10 tablets. Matching placebo tablets were formulated to be indistinguishable from the everolimus tablets. Everolimus placebo was taken as a daily oral dose of 7.5 mg and was defined as the control drug.
16246403|NCT01035229|Other|Best Supportive Care (BSC)|BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions
16246404|NCT01035216|Drug|GNKG168|GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.
16246405|NCT01035203|Behavioral|Exercise|Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
16246406|NCT01035203|Behavioral|Cognitive behavioural therapy|Teaching of techniques to reduce fatigue and to improve stamina
16246407|NCT01035190|Drug|Budesonide|Inhalation, 200 µg/puff
16246408|NCT01035164|Drug|F-18 FEDAA1106 (BAY85-8101)|Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
16246409|NCT01035164|Drug|F-18 FEDAA1106 (BAY85-8101)|Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
16246410|NCT01035164|Drug|F-18 FEDAA1106 (BAY85-8101)|Healthy volunteers for whole body imaging: Single intravenous bolus injection of 185 MBq BAY85-8101, whole body PET for evaluation of effective dose, kinetics of BAY85-8101 in blood
16246411|NCT01035151|Behavioral|Experimental|Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
16246412|NCT01035151|Behavioral|Control|Written Cessation Materials
16246413|NCT01035138|Drug|semagacestat|140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
16246414|NCT01035125|Behavioral|Self-management program|Participants will receive a one week inpatient self-management program
16246415|NCT01035112|Procedure|MRI|
16246416|NCT01035099|Drug|Letrozole|"Letrozole titrated regimen may be started on day 2 of menstrual cycle:
~Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;"
16246417|NCT01035099|Drug|Letrozole|Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle
16246418|NCT01035086|Dietary Supplement|fabricated food|The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After a one-week run-in period, each volunteer had to pass all three periods (arms) in different order with a two-week wash-out period between each.
16246419|NCT01035073|Drug|Duloxetine|30-60 mg daily for 8 weeks
16246420|NCT01035047|Other|Clinical decision unit care, coupled with cardiac MRI|After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
16246421|NCT01035034|Procedure|Hybrid MIDCAB/PCI|"MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.
~Device: Polymer-based Sirolimus-Eluting Stents (SES)."
16246422|NCT01035034|Procedure|PCI with DES|Polymer-based Sirolimus-Eluting Stents (SES)
16246423|NCT01035021|Drug|use of rocuronium when the LMA is inserted|Anesthesia is induced with a propofol and remifentanil in both groups, however rocuronium 0.06 mg/kg is injected only in group R. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. In group N, rocuronium is administered for the operation.
16246424|NCT01035008|Procedure|Endoscopic Ultrasound (EUS)|The investigators will do the standard EUS procedure. If a cyst is seen in the pancreas during EUS, the investigators will administer a special dye called fluorescein through the IV, and then use the new fiber-shaped microscope to take pictures of the lining of the cysts.
16246425|NCT01034995|Drug|SSR125543|"Pharmaceutical form: capsule
~Route of administration: oral"
16246426|NCT01034995|Drug|escitalopram|"Pharmaceutical form: encapsulated tablets
~Route of administration: oral"
16246427|NCT01034995|Drug|placebo|"Pharmaceutical form: capsule
~Route of administration: oral"
16246428|NCT01034982|Drug|AZD9668|20 mg
16246429|NCT01034982|Drug|AZD9668|60 mg
16246430|NCT01034956|Device|hyaluronic acid or calcium hydroxylapatite filler|Intradermal and subdermal injection of facial soft tissue filler within the past 24 months; survey of patients to assess satisfaction and determine the presence of treatment related adverse events.
16246431|NCT01034943|Procedure|External fixation|Operation with external fixation and optional addition of k-wire
16246432|NCT01034943|Procedure|Volar plate|Operation with a Synthes volar two column plate (TCP)
16246433|NCT01034930|Procedure|Insertion of dental implants|Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.
16246434|NCT01034917|Drug|Etravirine 400 mg dissolved in water every 24 hours|Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
16246435|NCT01034917|Drug|Continue with the same antiretroviral regimen|Continue with the same antiretroviral regimen
16246436|NCT01034878|Drug|Sunitinib|Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.
16246437|NCT01034852|Procedure|Totally Thoracoscopic Maze|Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician
16246438|NCT01034787|Drug|CP-675,206|Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of ever 90 cycle for up to 4 cycles or until progression or intolerance of toxicity. Tumor assessments will be done ever 3 months. Additional scans will be done if clinically indicated.
16246439|NCT01034774|Drug|ACHN-490 Injection|ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment.
16246440|NCT01034774|Drug|Placebo (normal saline)|Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
16246441|NCT01034761|Behavioral|Pop-up alert|Pop-up alert in the electronic medical record whenever the provider enters an order for a specified high risk medication from the Beers list.
16246442|NCT01034748|Drug|[14C]PF00299804|Single 45 mg oral dose of radiolabelled PF-00299804
16246443|NCT01034735|Biological|r-hGH liquid (Saizen)|Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL)
16246444|NCT01034735|Biological|r-hGH liquid (Saizen)|Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL)
16246445|NCT01034735|Biological|r-hGH freeze-dried|Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)
16246446|NCT01034683|Drug|lobaplatin , 5-FU ,leucovorin|Participants received 2-hour lobaplatin (30 mg/m2 on day 1) and a 2-hour infusion of leucovorin (LV; 200 mg/m2 on days 1-5) followed by a 4-hour infusion of 5-FU (650 mg/m2 on days 1-5). Treatment was repeated every 21 days.
16246447|NCT01034670|Device|Dual axis endoscopic microscope|This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.
16246448|NCT01034670|Device|wide field fluorescence system|This is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope.
16246449|NCT01034670|Device|CellVizio|Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
16246450|NCT01034670|Drug|fluorescent Peptide|microdosing; Topical through the endoscope
16246451|NCT01034670|Drug|fluorescein|100 mcg topical
16246452|NCT01034670|Drug|indocyanine green|100 mcg topical
16246453|NCT01034657|Drug|LBH589|LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.
16246454|NCT01034657|Drug|Epoetin Alfa|Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.
16246455|NCT01034631|Drug|Everolimus|Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
16246456|NCT01034631|Drug|BNC105P|BNC105P, up to 16 mg/m^2
16246457|NCT01034618|Dietary Supplement|Protein hydrolyzation|
16246458|NCT01034605|Dietary Supplement|PinnoThin|6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose
16246459|NCT01034592|Drug|Lenalidomide|2.5 mg/wk up to 5 mg 3x/wk
16246460|NCT01034579|Other|Blood sampling|Subjects who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.
16246461|NCT01034579|Other|Blood sampling|Subjects who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.
16246462|NCT01034566|Radiation|Proton Beam Radiation Therapy|
16246463|NCT01034553|Drug|Aurora A kinase inhibitor MLN8237|Given orally
16246464|NCT01034553|Drug|bortezomib|Given IV
16246465|NCT01034540|Drug|POM3|4 g/day
16246466|NCT01034540|Drug|Placebo|matching placebo capsule, 4 g/day
16246467|NCT01034527|Other|Neuromuscular Training|Combination of exercises and phases to initiate lateral trunk perturbations that force the athlete to decelerate and control the trunk in order to successfully perform the techniques.
16246468|NCT01034514|Device|Real-time Position Management system|Standard of Care
16246469|NCT01034514|Device|Discovery ST multislice PET/CT scanner|Standard of Care
16246470|NCT01034514|Device|Infinia Hawkeye SPECT/CT gamma camera|Standard of Care
16246471|NCT01034514|Device|Pinnacle3 treatment planning system|Standard of Care
16246472|NCT01034514|Device|SKYLight nuclear camera|Standard of Care
16246473|NCT01034514|Drug|DTPA|1 mCi; inhalation
16246474|NCT01034514|Drug|TECHNETIUM TC 99M MAA|3 mCi; iv
16246475|NCT01034501|Device|sham procedure|non activated laser tip
16246476|NCT01034501|Device|photodynamic therapy|photodynamic therapy 660 nm,40 mW,60 Hz
16246477|NCT01034488|Biological|Suine|5000UI /mL
16246478|NCT01034488|Biological|Suine|5000UI/mL
16246479|NCT01034475|Drug|CPI-613|"This is a Phase I open label trial using a 2-stage dose-escalation scheme (single-patient & traditional stages):
~Single-Patient Dose-Escalation Stage: In the single-patient stage, a single patient will be accrued per dose level. The starting dose will be 420 mg/m². Dose level will be escalated (by doubling the previous dose) if there is no toxicity or if the toxicity is grade 1 or less. If toxicity is >Grade 1, the traditional dose-escalation stage will be triggered.
~Traditional Dose-Escalation: All dose escalations conducted in this Traditional Dose-Escalation stage will be escalated according to the modified Fibonacci Dose-Escalation scheme."
16246480|NCT01034462|Drug|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
16246481|NCT01034462|Drug|Placebo|Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
16246482|NCT01034449|Other|allogeneic transplant|ex vivo amplification of a unit of placental blood for transplantation
16246483|NCT01034436|Dietary Supplement|fatty acid quality and overweight|Duration 12 weeks
16246484|NCT01034423|Dietary Supplement|Omega-3|Capsules with omega-3 fatty acids.
16246485|NCT01034423|Dietary Supplement|sun flower oil|Capsules with sun flower oil.
16246486|NCT01034410|Drug|AS1411|AS1411 40mg/kg/day or AS1411 80mg/kg/day
16246487|NCT01034410|Drug|Cytarabine|Cytarabine 2g/m2 bid Days 4-7
16246488|NCT01034397|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks
16246489|NCT01034397|Drug|placebo|iv every 4 weeks for 24 weeks
16246490|NCT01034397|Drug|non-biological DMARDs|stable dose at investigator's prescription
16246491|NCT01034371|Procedure|Minimally invasive direct coronary artery bypass|MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
16246492|NCT01034371|Procedure|PCI-Drug eluting stents|"PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.
~Device: Polymer-based Sirolimus-Eluting Stents (SES)."
16246493|NCT01034371|Procedure|Off-pump coronary artery bypass|Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
16246494|NCT01034358|Biological|Human Papillomavirus Vaccine|0.5mL intramuscular for 3 doses at 0, 2, and 6 months
16246495|NCT01034345|Drug|Sirolimus|Switch from calcineurin inhibitor maintenance immunosuppression to sirolimus treatment at the doses needed to reach trough blood levels 8-15 ng/mL.
16246496|NCT01034345|Drug|Calcineurin inhibitor|Patients will maintain the same immunosuppressive regimen based on calcineurin inhibitors. No modifications in the treatment will be conducted.
16246497|NCT01034332|Procedure|TP-HDFL,TP-CCRT, Esophagectomy|To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT) in patients with locally advanced esophageal cancer.
16246498|NCT01034319|Behavioral|Diabetes Genetic Counseling|Subjects will be genotyped based on a 37-allele aggregate score and counseled regarding the implications of the results prior to enrollment in a 12-week diabetes prevention program
16246499|NCT01034319|Behavioral|No genetic counseling|These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program
16246500|NCT01034306|Drug|CF101|orally q12h
16246501|NCT01034306|Drug|Placebo control|orally q12 hours
16246502|NCT01034293|Dietary Supplement|low feeding frequency (3x)|3 meals a day
16246503|NCT01034293|Dietary Supplement|High feeding frequency (14x)|14 meals a day
16246504|NCT01034267|Drug|F2695 SR|Drug F2695 SR (flexible dose) to be given orally in capsule form once daily
16246505|NCT01034254|Biological|influenza vaccine|Pregnant women will receive FDA approved influenza vaccine.
16246507|NCT01034241|Dietary Supplement|Control|Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
16246508|NCT01034241|Dietary Supplement|High dairy protein|Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
16246509|NCT01034241|Dietary Supplement|vegetable protein|Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat
16246510|NCT01034241|Dietary Supplement|High GI|Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat
16246511|NCT01034228|Other|ORS + Isoleucine|ORS with Isolelucine for treatment of diarrhoeal in children
16246512|NCT01034228|Other|ORS without Isoleucine|ORS without Isoleucine for the treatment of diarrhoea in children
16246513|NCT01034215|Behavioral|Envision the Rhythms of Life Program|Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered with trainer present in the room.
16246514|NCT01034215|Behavioral|Envision the Rhythms of Life Program/Distance|Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered by videoconference equipment
16246515|NCT01034202|Drug|NNC126-0083|One of five dose levels administered subcutaneously (under the skin)
16246516|NCT01034202|Drug|Norditropin® SimpleXx®|One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
16246517|NCT01034202|Drug|placebo|Placebo comparator
16246518|NCT01034202|Drug|NNC126-0083|One of three dose levels administered subcutaneously (under the skin)
16246519|NCT01034202|Drug|Norditropin® SimpleXx®|One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
16246520|NCT01034189|Drug|Cetuximab|Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).
16246521|NCT01034189|Drug|Paclitaxel|T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.
16246522|NCT01034189|Drug|Cisplatin|P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.
16246523|NCT01034189|Radiation|Radiotherapy|Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.
16246524|NCT01034176|Drug|levofloxacin|500 mg tablet, daily, 30 days
16246525|NCT01034176|Drug|placebo|no dose, tablet, daily, 30 days
16246526|NCT01034163|Drug|Panobinostat|
16246527|NCT01034163|Drug|Placebo|Placebo
16246528|NCT01034150|Device|Relief band (Somatosensory stimulation)|Electrical median nerve stimulation
16246529|NCT01034150|Device|Placebo stimulation|Placebo stimulation
16246530|NCT01034137|Drug|methotrexate|orally weekly in ascending dosages, starting at 10mg/week
16246531|NCT01034137|Drug|placebo MTX|orally weekly
16246532|NCT01034137|Drug|placebo TCZ|iv every 4 weeks
16246533|NCT01034137|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
16246534|NCT01034124|Drug|warfarin, vitamin K, midazolam|warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
16246535|NCT01034111|Drug|Sitagliptin phosphate|Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
16246536|NCT01034111|Drug|Metformin|Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
16246537|NCT01034046|Other|Low Carbohydrate Diet|Low carbohydrate diet (45% carbohydrate, 35% fat and 20% protein diet) administered utilizing meal replacements.
16246538|NCT01034046|Other|Low Fat Diet|Low fat diet (60% carbohydrate, 20% fat and 20% protein diet) administered utilizing meal replacements.
16246539|NCT01034020|Drug|Nicotine|
16246540|NCT01034007|Combination Product|Tissue Engineered Vascular Grafts|Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)
16246541|NCT01033994|Biological|AS902330|10, 30 or 100 µg intra-articular injection per subject in the Single Ascending Dose (SAD) cohorts and 10, 30 or 100 µg intra-articular injection per week for three weeks per subject in the Multiple Ascending Dose (MAD) cohorts.
16246542|NCT01033981|Drug|Sunitinib|Treatment for mRCC as indication approved and physician criterium
16246543|NCT01033968|Procedure|retina photocoagulation|Each patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength
16246544|NCT01033955|Drug|Rosuvastatin|Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
16246545|NCT01033955|Drug|Placebo|identical appearing encapsulated placebo.
16246546|NCT01033942|Drug|coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP|Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
16246547|NCT01033942|Drug|Placebo|Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
16246548|NCT01033942|Behavioral|Many Men, Many Voices (3MV)|Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
16246549|NCT01033929|Biological|rdESAT-6 + rCFP-10 (C-Tb)|rdESAT-6 + rCFP-10 (C-Tb) skin test +/- phenol administered intradermally by the mantoux injection technique. Each patient receives the unpreserved version in one arm and the preserved version in the other arm in double blind manner.
16246550|NCT01033916|Other|LIBERAL|The LIBERAL arm of the study will have a target Blood Glucose level ranging from 121-180 mg/dL. As opposed to the standard of less than 120 mg/dL.
16246551|NCT01033903|Drug|misoprostol|800 micrograms intravaginally ONCE
16246552|NCT01033877|Biological|TdaP vaccine SSI|1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d), 20 microgram pertussis toxoid (aP)
16246553|NCT01033877|Biological|Td vaccine SSI|1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d)
16246555|NCT01033864|Drug|EC-MPS|720 mg b.i.d. p.o. for at least 1 month
16246556|NCT01033864|Drug|Prednisone|5 mg per day p.o.
16246557|NCT01033851|Behavioral|Mindfulness Based Stress Reduction|8 week course
16246558|NCT01033851|Behavioral|Stress Management Education|8 week course
16246559|NCT01033838|Procedure|rectosigmoid resection|
16246560|NCT01033825|Drug|Ciclesonide HFA Nasal Aerosol 320 mcg|Ciclesonide HFA Nasal Aerosol 320 μg once daily
16246561|NCT01033825|Drug|Ciclesonide HFA Nasal Aerosol 160 mcg|Ciclesonide HFA Nasal Aerosol 160 μg once daily
16246562|NCT01033825|Drug|HFA Nasal Aerosol placebo|HFA Nasal Aerosol placebo once daily
16246563|NCT01033825|Drug|Ciclesonide Aqueous Nasal Spray 200 mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
16246564|NCT01033825|Drug|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
16246565|NCT01033825|Drug|Placebo plus Dexamethasone HFA|Dexamethasone capsules 6 mg once daily
16246566|NCT01033825|Drug|Placebo AQ plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mcg capsules once daily
16246567|NCT01033799|Other|Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)|
16246568|NCT01033799|Other|Non fermented dairy product (control)|
16246569|NCT01033773|Drug|Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin|Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications.
16246570|NCT01033773|Behavioral|Diabetes survival skills self-management education|Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.
16246571|NCT01033760|Drug|raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine|raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
16246572|NCT01033760|Drug|darunavir; ritonavir; emtricitabine/tenofovir|darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
16246573|NCT01033747|Drug|Deferasirox|10 mg/kg or 30 mg/kg orally daily
16246574|NCT01033747|Drug|Deferasirox|5 mg/kg or 30 mg/kg orally daily
16246575|NCT01033734|Drug|oseltamivir [Tamiflu]|5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.
16246576|NCT01033721|Drug|Palomid 529|comparison of different dosages of drug
16246577|NCT01033708|Behavioral|narrative exposure therapy|Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
16246578|NCT01033669|Device|CRC-749|There is no drug being used. This is a device.
16246579|NCT01033669|Device|Diskus|There is no drug being used. This is a device.
16246580|NCT01033669|Device|Twisthaler|There is no drug being used. This is a device.
16246581|NCT01033669|Device|Miat Monohaler|There is no drug being used. This is a device.
16246582|NCT01033656|Drug|anakinra|100 mg subcutaneous injection daily
16246583|NCT01033656|Drug|comparators|po drugs, comparators
16246584|NCT01033643|Drug|MK-3614|Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization.
16246585|NCT01033643|Drug|Placebo for MK-3614|Participants were administered dose matched placebo tablets according to randomization.
16246586|NCT01033630|Drug|D&G 2g|Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 2g per Day
16246587|NCT01033630|Drug|D&G 1g|Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 1g per Day
16246588|NCT01033630|Drug|Placebo|Image-matched placebo, made with starch.
16246589|NCT01033617|Procedure|Injection of stem cells at time of coronary artery bypass grafting|Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells,or placebo solution containing plasma and indistinguishable will be injected in the myocardium. A total of 2.0 ml with 10-15 injections will be injected.
16246590|NCT01033604|Procedure|Glyaderm and split skin graft|Full thickness defects treated with Glyaderm and split skin graft.
16246591|NCT01033604|Procedure|Split skin graft alone.|Full thickness defects treated with split skin graft alone.
16246592|NCT01033591|Behavioral|Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment|Three month supervised progressive exercise program with an aerobic (high intensity intervals) and a strength component; and the programme will continue linked with community resources for 9 months
16246593|NCT01033591|Behavioral|Optimized treatment according to the European Society of Cardiology guidelines|Optimized treatment according to the European Society of Cardiology guidelines
16246594|NCT01033578|Other|PVIC, TACE|"PVIC：5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) were continuously infused into portal vein through tube by a infusion pump. Treatment started 2 weeks after the operation and was repeated every 4 weeks for 6 cycles.
~TACE: 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles."
16246595|NCT01033565|Drug|Natrol|5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.
16246596|NCT01033552|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/kg/day IV over 2 hours x 1 day, total dose 50 mg/kg will be administered on Day -6.
16246597|NCT01033552|Drug|Fludarabine|40 mg/m^2/day intravenously on Days -6, -5, -4, -3 and -2.
16246598|NCT01033552|Drug|Anti-thymocyte globulin|30 mg/kg on Days -4, -3 and -2.
16246599|NCT01033552|Drug|Cyclosporine A|Days -3 to 100+ to maintain a level of >200 ng/ml; initial dose 2.5 mg/kg over 2 hours every 8-12 hours for children.
16246600|NCT01033552|Drug|Mycophenolate mofetil|15 mg/kg intravenous twice per day on days -3 through 30.
16246601|NCT01033552|Procedure|Mesenchymal stem cell transplantation|infused via intravenous drip on Day 0
16246602|NCT01033552|Radiation|Total body irradiation|300 cGY on Day -1 administered in a single fraction at a dose rate of 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.
16246603|NCT01033552|Procedure|Bone marrow or umbilical cord blood (UCG) stem cell transplantation|Bone marrow or UCB products will be infused as soon as the product arrives and within 30 minutes. The product is infused via IV drip.
16246604|NCT01033539|Other|Probiotic strain ATCC PTA 4659|Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1*10 10 CFU/bag Low dose of ATCC PTA 4659 1*10 8 CFU/bag
16246605|NCT01033526|Drug|Aspirin (Acetylsalicylic acid, BAYE4465)|1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days
16246606|NCT01033526|Drug|Placebo|1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
16246607|NCT01033500|Drug|Belatacept|Belatacept 10mg/kg on Days 0, 4, 14, 28, 56, and 84 post-transplant, and then 5mg/kg every 4 weeks for the duration of the study.
16246608|NCT01033487|Drug|placebo|oral inhaled formulation, single dose
16246609|NCT01033487|Drug|active comparator|oral inhaled formulation, single dose
16246610|NCT01033487|Drug|Low Dose PF-03635659|oral inhaled formulation, single dose, low dose
16246611|NCT01033487|Drug|Mid Dose PF-03635659|oral inhaled formulation, single dose, mid dose
16246612|NCT01033487|Drug|High Dose PF-03635659|oral inhaled formulation, single dose, high dose
16246613|NCT01033461|Dietary Supplement|calcium and probiotic|the subjects consumed for 4 weeks a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 and a bread enriched with 1 g pentacalcium phosphate per day
16246614|NCT01033461|Dietary Supplement|probiotic|the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks
16246615|NCT01033461|Other|placebo|the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate
16246616|NCT01033448|Drug|COPEGUS|COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
16246617|NCT01033448|Drug|peginterferon alfa-2a [Pegasys]|PEGASYS 180 micrograms sc once weekly for 24 weeks
16246618|NCT01033435|Other|No intervention|
16246619|NCT01033422|Drug|CF101|CF101 1 or 2 mg tablets orally every 12 hours for 16 weeks
16246620|NCT01033422|Drug|Placebo for|Matching placebo tablets orally every 12 hours for 16 weeks
16246621|NCT01033409|Biological|Salmonella Typhi-vectored pneumonia vaccine|Liquid, oral dosage administered once at 10^7 CFU in 10 mL phosphate-buffered saline
16246622|NCT01033409|Biological|Salmonella Typhi-vectored pneumonia vaccine|Liquid, oral dosage administered once at 10^8 CFU in 10 mL phosphate-buffered saline
16246623|NCT01033409|Biological|Salmonella Typhi-vectored pneumonia vaccine|Liquid, oral dosage administered once at 10^9 CFU in 10 mL phosphate-buffered saline
16246624|NCT01033409|Biological|Salmonella Typhi-vectored pneumonia vaccine|Liquid, oral dosage administered once at 10^10 CFU in 10 mL phosphate-buffered saline
16246625|NCT01033396|Drug|PF-03654764|PF-03654764 single dose 5 mg
16246626|NCT01033396|Drug|Allegra|Fexofenadine single dose 60 mg
16246627|NCT01033396|Drug|PF-03654764|PF-03654764 single dose 5 mg
16246628|NCT01033396|Drug|Allegra-D|Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
16246629|NCT01033396|Drug|Placebo|Placebo single dose
16246630|NCT01033383|Dietary Supplement|Placebo|36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).
16246631|NCT01033383|Dietary Supplement|Cranberry Capsule|36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).
16246632|NCT01033370|Drug|clevidipine.|Clevidipine administered per IV infusion, starting dose of 2 mg/h (4 mL/hr) for 3 minutes & titrated to the desired BP lowering effect to SBP goal of < 120 mmHg, max infusion rate may not exceed 32 mg/h (64 mL/hr).
16246633|NCT01033357|Device|Graft, Vascular Wrap|Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
16246634|NCT01033357|Device|Lifespan® ePTFE Vascular Graft Only|Vascular Graft only
16246635|NCT01033344|Biological|Placebo|Intradermal injection 1x8 administrations 2 weeks apart
16246636|NCT01033344|Biological|Cat-PAD|Intradermal injection 1x8 administrations 2 weeks apart
16246637|NCT01033344|Biological|Cat-PAD|Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo
16246638|NCT01033318|Drug|MK1809|single oral doses of MK1809
16246639|NCT01033318|Drug|Comparator: Losartan|single oral doses of 100 mg Losartan
16246640|NCT01033318|Drug|Comparator: Placebo|Placebo to MK1809
16246641|NCT01033305|Drug|CyCol™|Orally, once per day for 4 weeks
16246642|NCT01033305|Drug|Placebo|Orally, once per day for 4 weeks
16246643|NCT01033292|Drug|BSI-201|IV infusion, 5.6 mg/kg
16246644|NCT01033279|Other|Self-monitoring and adjustment of oral anticoagulation|Weekly self-monitoring of oral anticoagulation with a portable coagulometer and predefined adjustment algorithms for 4 months following a training program led and designed by hospital pharmacists
16246645|NCT01033266|Diagnostic Test|CPET|CPET will be done on patients with overlap syndrome before and after clinical CPAP treatment.
16246646|NCT01033253|Behavioral|Health in Motion|Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest.
16246647|NCT01033240|Drug|CS-1008 2 mg/kg|On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
16246720|NCT01032746|Procedure|evaluation of cancer risk factors|
16246721|NCT01032746|Procedure|fecal occult blood test|
16246722|NCT01032746|Procedure|screening colonoscopy|
16246648|NCT01033240|Drug|Sorafenib|On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
16246649|NCT01033240|Drug|CS-1008 6/2 mg/kg|A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.
16246650|NCT01033240|Drug|CS-1008 6/6 mg/kg|A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.
16246651|NCT01033240|Drug|CS-1008 4 mg/kg|On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
16246652|NCT01033240|Drug|CS-1008 6 mg/kg|On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.
16246653|NCT01033227|Drug|sodium nitrite injection, usp|Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).
16246654|NCT01033214|Device|Endovascular repair of TAA in the descending Thoracic Aorta|Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
16246655|NCT01033201|Other|Confocal imaging|At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.
16246656|NCT01033188|Procedure|Single bundle|"Procedure:
~Transarthroscopic technique with medial portal placement of the femoral tunnel. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus. The femoral tunnel is positioned at the anatomic foot print determined by the anatomic landmarks. The graft will be fixed with an Endobutton CL on the femur and with an Biosure PK screw in the tibia with the knee close to extension. Prior to the final fixation, the knee will be taken through flexion and extension movements.The surgery will be carried out by an experienced knee surgeon."
16246657|NCT01033188|Procedure|Double bundle|"Procedure:
~Transarthroscopic technique. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus.Through a medial portal 2 tunnels will be anatomically placed in the foot print on the femur and the two tibial tunnels will be placed using the Smith & Nephew drill guide. The graft will be fixed with 2 Endobuttons on the femur and with 2 Biosure PK screws in the tibia. Prior to the final fixation, the knee will be taken through 20 flexion and extension movements. The PL bundle will be fixed with the knee close to ful extension. The surgery will be carried out by an experienced knee surgeon."
16246658|NCT01033175|Procedure|maximal cardiopulmonary exercise testing|Cardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness).
16246659|NCT01033175|Procedure|peripheral blood samples|Peripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits.
16246660|NCT01033162|Behavioral|Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)|"Half of the participating women will be randomly assigned to use an informative but static website (Basic ICCS), and half will be offered a fully interactive CHESS (Enhanced ICCS + the Basic ICCS). Study outcome data will be gathered from patients, clinicians, and the healthcare system (i.e., from the electronic medical record: EMR) for at least 8 months after study entry. We propose that the Enhanced ICCS relative to the Basic ICCS, will:
~Improve patients' sense of cancer information competence (perceived ability to obtain and use relevant information)
~Reduce patients' negative affect and increase their emotional well being
~Improve patients' sense of social support
~Improve patients' health self-efficacy
~Improve patients' ratings of experience with cancer specialty care services
~Improve patients' health related quality of life (HRQL)
~Improve clinicians' ratings of quality of patient contacts
~Reduce healthcare utilization and costs (obtained via the EMR)"
16246661|NCT01033149|Drug|N-acetylcysteine|N-acetylcysteine, flexible dose 1200-2400mg/day
16246662|NCT01033136|Behavioral|Multiple Channel Exposure Therapy - Veterans|MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.
16246663|NCT01033136|Behavioral|Cognitive Processing Therapy|CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
16246664|NCT01033123|Drug|BSI-201|IV infusion, 5.6 mg/kg
16246665|NCT01033110|Behavioral|Exercise and Nutrition Education|Guided nordic walking training and 12 presentations about diet and health.
16246666|NCT01033097|Drug|DNK333 5 mg|5 mg oral
16246667|NCT01033097|Drug|Placebo to 5 mg|5 mg placebo oral
16246668|NCT01033097|Drug|DNK333 25 mg|25 mg oral
16246669|NCT01033097|Drug|Placebo to 25 mg|25 mg placebo oral
16246670|NCT01033097|Drug|DNK333 100 mg|100 mg oral
16246671|NCT01033097|Drug|Placebo to 100 mg|100 mg placebo oral
16246672|NCT01033097|Drug|Betamethasone 4 mg|4 mg oral
16246673|NCT01033097|Drug|DNK333 1mg|1 mg oral
16246674|NCT01033097|Drug|Placebo to 1mg|1 mg placebo oral
16246675|NCT01033084|Device|transcranial direct current stimulation|Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6.
16246676|NCT01033084|Drug|Sertraline|Patient will receive sertraline 50mg/day.
16246677|NCT01033084|Other|double placebo|double placebo arm (sham stimulation/placebo pill)
16246678|NCT01033071|Drug|Azilsartan medoxomil and chlorthalidone|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
16246679|NCT01033071|Drug|Azilsartan medoxomil and chlorthalidone|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
16246680|NCT01033071|Drug|Olmesartan medoxomil and hydrochlorothiazide|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
16246681|NCT01033058|Drug|atorvastatin|80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI
16246682|NCT01033058|Drug|atorvastatin|No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI
16246683|NCT01033032|Drug|Amrubicin|"Phase I: dose escalating portion with the starting dose of amrubicin at 90mg/m2 IV q21 days. Dose escalations are as follows:
~DL2 - 100mg/m2; DL3 - 110mg/m2; and DL4 - 120mg/m2. All cycles are q21 days
~Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days"
16246684|NCT01033019|Drug|LDE225 0.75%|0.75% cream
16246685|NCT01033019|Drug|Vehicle|matching placebo cream to 0.75% LDE225 cream
16246686|NCT01033006|Procedure|Active Comparator: Arm 1: catheter injection|
16246687|NCT01033006|Procedure|Active Comparator: Arm 2: transarterial injection|
16246688|NCT01033006|Procedure|Active Comparator: Arm 3: catheter and transarterial injection|
16246689|NCT01032993|Dietary Supplement|Coenzyme Q10|300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
16246690|NCT01032993|Other|Placebo|Placebo (three chewable tablets) 2 times daily for 4 weeks
16246691|NCT01032967|Procedure|Esophagectomy|The patients will receive standard open esophagectomy with two-field lymphadenectomy
16246692|NCT01032967|Radiation|Definitive chemoradiation|3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.
16246693|NCT01032954|Drug|Botulinum toxin|"Drug: Botulinum toxin
~Indications for eligibility and total doses that will be applied in each part of the face, at visit 1:
~Upper face:
~Crow's feet wrinkles - 70 units
~Glabella - 50 units
~Forehead - 40 units
~Mid face:
~Lower eyelid - 5 units
~Nasal wrinkles - 20 units
~Malar wrinkles - 10 units
~Lower face:
~Peri-oral wrinkles - 15 units
~Asymmetric smile or gummy smile - 5 units
~Cellulitic chin - 20 units
~Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.
~Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs."
16246694|NCT01032941|Drug|Probiotic|Patients in this group will be given the probiotic VSL#3 2 packets BID for a total of 8 weeks.
16246695|NCT01032928|Behavioral|Respiratory-Swallow Phase training|Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
16246696|NCT01032915|Biological|AIN457|AIN457 300mg s.c weekly for 3 weeks then every 2 weeks
16246697|NCT01032915|Biological|AIN457|AIN457 300mg s.c at baseline and Week 2 then every 4 weeks
16246698|NCT01032915|Biological|AIN457|AIN457 150mg s.c at baseline and Week 2 then every 4 weeks
16246699|NCT01032915|Drug|Placebo|Placebo s.c weekly for 3 weeks then every 2 weeks
16246700|NCT01032902|Device|In Vitro Diagnostic Device|For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
16246701|NCT01032889|Drug|Deoxycholic acid injection|
16246702|NCT01032889|Drug|Placebo|Phosphate buffered saline placebo for injection
16246703|NCT01032876|Procedure|Deep Hypothermic Circulatory Arrest|DHCA will be employed for a maximum of 60 minutes. If more time (>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP).
16246704|NCT01032876|Procedure|Antegrade Cerebral Perfusion|One cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min.
16246705|NCT01032850|Drug|Sorafenib & Capecitabine|Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
16246706|NCT01032837|Drug|Oseltamivir|Oseltamivir capsules for participants ≥ 13 years.
16246707|NCT01032837|Drug|Oseltamivir|Pediatric suspension for participants aged ≤ 12 years.
16246708|NCT01032837|Drug|Placebo|Matching placebo provided as capsules and as a suspension.
16246709|NCT01032824|Behavioral|Individual Telephone Counseling Intervention|10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.
16246710|NCT01032824|Other|Group Arm|10-session didactic telephone group
16246711|NCT01032824|Other|Book Arm|Book only.
16246712|NCT01032798|Drug|mepivacaine|One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.
16246713|NCT01032785|Device|no interventions|no interventions
16246714|NCT01032772|Behavioral|Choices Plus|Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
16246715|NCT01032772|Behavioral|Information|Participants are provided with informational materials about healthy lifestyle and local resources.
16246716|NCT01032759|Drug|Memantine|20 mg, BID
16246717|NCT01032759|Drug|Placebo|BID
16246718|NCT01032746|Other|educational intervention|
16246719|NCT01032746|Other|internet-based intervention|
16246723|NCT01032733|Behavioral|Lifestyle Counseling|In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week.
16246724|NCT01032733|Other|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss (e.g., skin protection).
16246725|NCT01032720|Procedure|Ultrasound|Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
16246726|NCT01032720|Procedure|Sham ultrasound|Knee CS injection will be performed in the same method as the US-guided injection except that the US machine will be turned off. Study patient will be unaware of whether US machine is on or off.
16246727|NCT01032694|Drug|Azithromycin SR|Azithromycin SR, 2.0 g PO x 1 dose for treatment period
16246728|NCT01032694|Drug|Amoxiclav|Amoxiclav 1000 x twice daily, 10 days duration
16246729|NCT01032681|Biological|EMD 521873|"Dose escalation steps:
~Group 1: 0,075mg/kg - 0,15mg/kg - 0,225mg/kg - 0,3mg/kg - 0,45mg/kg - 0,6mg/kg - 0,9mg/kg (-1,8mg/kg - 2,1mg/kg - 2,5mg/kg - 3,0mg/kg)
~Disease control and decision of continuation in patient who benefit from the treatment:
~Every second cycle"
16246730|NCT01032681|Biological|EMD 521873|"Dose escalation steps:
~Group 2: CPA plus 0,6mg/kg - 0,9mg/kg
~Disease control and decision of continuation in patient who benefit from the treatment:
~Every second cycle"
16246731|NCT01032681|Biological|EMD 521873|"Dose escalation steps:
~Group 3: 0,9mg/kg - 1,2mg/kg - 1,5mg/kg (-1,8mg/kg - 2,1mg/kg - 2,5mg/kg - 3,0mg/kg)
~Disease control and decision of continuation in patient who benefit from the treatment:
~Every second cycle"
16246732|NCT01032668|Drug|Clopidogrel|high dose clopidogrel continuing after percutaneous coronary intervention
16246733|NCT01032655|Drug|susceptibility test guided sequential therapy|"susceptibility test driven sequential therapy D1- D7 Nexium ,40mg, bid Amolin, 1gm bid D8-14 Nexium ,, 40mg, bid Flagyl, 500mg, bid
~plus either one of the following
~Klaricid, 500 mg, bid
~Cravit, 250 mg, bid
~Tetracycline, 500 mg, bid"
16246734|NCT01032642|Device|device for hysterosalpingography|a thin catheter originally designed for IUI (sperm processor cat. No. SP/PL/01, Aurangabad, India) connected to a 10 mL syringe filled with urographin 76% (Scherring, Germany) will be introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum will be loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye will be injected slowly and the procedure will be watched on the screen and x-ray films will be taken.
16246735|NCT01032629|Drug|Placebo|One placebo capsule taken orally (by mouth) once daily
16246736|NCT01032629|Drug|Canagliflozin (JNJ-28431754) 100 mg|One 100 mg capsule taken orally (by mouth) once daily
16246737|NCT01032629|Drug|Canagliflozin (JNJ-28431754) 300 mg|One 300 mg capsule taken orally (by mouth) once daily
16246738|NCT01032616|Other|Threonine Experimental: Study Period 1|Enteral and parenteral infusion of threonine isotope
16246739|NCT01032616|Other|Lysine Experimental: Study Period 2|Both intravenous (iv) and intragastric (ig) Lysine isotopes.
16246742|NCT01032590|Behavioral|Internet weight loss intervention|Participants will be advised to login to the website twice a week during the intervention period. They will be prompted to report their weight, to review and update their reasons for weight loss, to indicate their success with implementing each of their weight loss strategies, to rate the perceived effectiveness of each weight loss strategy,and to revise or create new strategies, as needed.
16246743|NCT01032564|Other|The elastography (elasticity imagery)|This diagnosis mean use the ultrasonography to measure the tissues answer under pressure
16246744|NCT01032551|Behavioral|Vascular Access Decision Aid|The intervention group will receive a PtDA addressing vascular access for CA procedures. The PtDA is a brief lay summary that outlines, the purpose of the PtDA, a description of both femoral and radial approaches for CA procedures, what to expect from both approaches, the known risks/benefits of each access site (including a grading of the evidence), and a short assessment of the patients values. The values assessment is included in the PtDA as a means to help guide the patient through the decision making process. This section will ask the patient to explicitly state which features, risks, and benefits of each approach are important to them.
16246745|NCT01032512|Dietary Supplement|SUPPORTAN + GLUTAMINE PLUS|600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)
16246746|NCT01032512|Dietary Supplement|NO PREOPERATIVE NUTRITION SUPPORT|Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure
16246747|NCT01032499|Drug|oxytetracycline, taro elixir|comparison of treatment efficacy between oxytetracycline and taro elixir
16246748|NCT01032499|Drug|Taro Elixir|Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
16246749|NCT01032486|Drug|Rasagiline mesylate|Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily
16246750|NCT01032460|Device|intubate with the macintosh laryngoscope|intubate with the macintosh laryngoscope
16246751|NCT01032460|Device|intubate with the C-MAC laryngoscope|intubate with the C-MAC laryngoscope
16246752|NCT01032460|Device|intubate with the Airtraq device|intubate with the Airtraq device
16246753|NCT01032447|Behavioral|Navigator Support|Standard of Care
16246754|NCT01032434|Drug|sertraline|sertraline: 50-200mg/day
16246755|NCT01032421|Procedure|IVF procedure|
16246756|NCT01032408|Biological|Focetria®|7.5 ug of HA antigen; adjuvanted; monovalent
16246757|NCT01032408|Biological|Begrivac®|15 ug of HA antigen; non-adjuvanted; trivalent
16246758|NCT01032395|Biological|Focetria®|7.5 ug of HA antigen; adjuvanted; monovalent
16246759|NCT01032395|Biological|Fluad®|15 ug of HA antigen; adjuvanted; trivalent
16246760|NCT01032395|Biological|Begrivac®|15 ug of antigen; non-adjuvanted; trivalent
16246761|NCT01032382|Drug|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)|topical application to CL lesions once daily for 20 days
16246762|NCT01032382|Drug|Paromomycin Alone Cream (15% paromomycin topical cream)|topical application to CL lesions once daily for 20 days
16246763|NCT01032369|Other|Nutritional intervention and physical activity|"Nutritional intervention:
~Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up.
~Physical activity:
~All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking)."
16246764|NCT01032369|Other|Nutritional intervention, physical activity and behavioral treatment|"Nutritional intervention:
~Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up.
~Physical activity:
~All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking).
~Behavioral treatment:
~This group will undergo behavioral treatment focusing on self control techniques using the CBT technique (cognitive behavioral therapy) which will be conducted by a clinical psychologist from ONIM in weekly group sessions."
16246765|NCT01032356|Device|Wrist Extension Dynasplint|"Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen"
16246766|NCT01032343|Dietary Supplement|Omega-3 PUFA|One capsule (4g omega-3 PUFA) daily for 3 months
16246767|NCT01032343|Dietary Supplement|Gelatine|One capsule daily for 3 months
16246768|NCT01032330|Device|occlusion treatment|Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
16246769|NCT01032317|Device|Radiofrequency Catheter Ablation|The Biosense Webster EZ Steer ThermoCool NAV Diagnostic / Ablation Deflectable Tip Catheter with Contact Force Sensing Capability is designed to facilitate electrophysiological mapping and transmit radiofrequency current as well as provide a real-time measurement of contact force.
16246770|NCT01032304|Drug|Erdosteine|One 300 mg capsule twice a day
16246771|NCT01032304|Drug|Placebo|One capsule twice a day
16246772|NCT01032291|Drug|cetuximab|Intravenous infusions of cetuximab (400 mg/m^2 Cycle 1 Day 1, thereafter 250 mg/m^2), administered on days 1, 8, 15 and 22 of each 28 day cycle.
16246773|NCT01032291|Drug|lenalidomide|Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
16246774|NCT01032278|Other|Laboratory Biomarker Analysis|Blood drawn for biomarker analysis at baseline, before each chemotherapy visit, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
16246775|NCT01032278|Behavioral|Questionnaires|Symptom questionnaire completion at baseline, beginning of every third cycle of chemotherapy, 6 months after starting chemotherapy, and 12 months after completion of chemotherapy.
16246776|NCT01032265|Behavioral|Web-based treatment with PFMT and elements of CBT|125 women with stress urinary incontinence(SUI) participate in web-based treatment for 3 months. Treatment consists of information, PFMT and uses elements of CBT. It includes regular email contact with urotherapist.
16246777|NCT01032265|Behavioral|Pamphlet treatment|125 women with SUI receive a pamphlet with information and a programme for PFMT.
16246778|NCT01032252|Other|Exercise intervention|"16 week exercise once a week of 60 minutes intervention by trained fall prevention instructors and a home program.
~Intervention includes strength/power training, balance/gait training, behavioral aspects and perceptual and functional training."
16246779|NCT01032239|Drug|intrathecal baclofen|ITB test, implant, 6 months follow-up
16246780|NCT01032213|Drug|Magnesium Sulfate|Group M received 50 mg/kg of magnesium sulphate on 100 ml of isotonic saline over 10 minutes during the anesthesia induction, followed by the 15 mg/kg/h by continuous infusion during the operation
16246781|NCT01032213|Drug|normal saline|Group S received the same volume of isotonic saline as same method.
16246782|NCT01032200|Drug|Armodafinil|Given orally
16246783|NCT01032200|Other|placebo|Given orally
16246784|NCT01032187|Drug|Meglumine antimoniate|20mg/kg/day IV for 20 days
16246785|NCT01032187|Drug|Amphotericin B-deoxycholate|Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
16246786|NCT01032174|Drug|Azithromycin SR|Azithromycin SR, 2.0 g by mouth (PO) x 1
16246787|NCT01032174|Drug|Amoxiclav 1000 mg|Amoxiclav 1000 mg x twice daily, 10 days
16246788|NCT01032148|Drug|LBH589|LBH589 will be administered orally as once daily dose of 20 mg po q M, W, F on a q28 day cycle.
16246789|NCT01032135|Behavioral|Motivational Interviewing|2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
16246790|NCT01032135|Behavioral|Telephone counseling|one telephone counseling session per week for 10 weeks.
16246791|NCT01032135|Behavioral|Cognitive Behavioral Therapy (CBT) Counseling|One CBT session per week, for 10 weeks.
16246792|NCT01032135|Drug|medication management|Prescription for naltrexone
16246793|NCT01032135|Behavioral|Intensive OutPatient Therapy|Return to IOP, group therapy 3 times weekly for about three hours a day.
16246794|NCT01032122|Drug|rituximab|induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
16246795|NCT01032109|Drug|Bevacizumab|A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.
16246796|NCT01032083|Drug|Citalopram|Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.
16246797|NCT01032083|Drug|Placebo|Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.
16246798|NCT01032070|Drug|erlotinib|oral
16246799|NCT01032070|Drug|etoposide|oral
16246800|NCT01032057|Drug|capecitabine|
16246801|NCT01032057|Drug|gemcitabine hydrochloride|
16246802|NCT01032057|Procedure|quality-of-life assessment|
16246803|NCT01032057|Radiation|3-dimensional conformal radiation therapy|
16246804|NCT01032044|Device|Standard endoscopic evaluation|Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
16246889|NCT01031446|Other|laboratory biomarker analysis|Blood collection
16246805|NCT01032044|Device|pCLE guided evaluation|Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.
16246806|NCT01032031|Dietary Supplement|Green tea + vitamin C high dose|One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months
16246807|NCT01032031|Dietary Supplement|Placebo capsule|One capsule daily for 3 months
16246808|NCT01032018|Behavioral|Problem Solving Therapy|Problem Solving Therapy (PST) will be administered by a trained provider. The concepts of PST will be taught to the participant in the first session and reinforced across subsequent sessions. Sessions will last between 30 and 60 minutes each and continue weekly for the duration of the study (6 months).
16246809|NCT01032018|Drug|Sertraline, citalopram, or bupropion|"Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week,with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST-PC after 2-4 weeks and 'restart' step 1.
~Sertraline: 25-150qam Citalopram: 10-40qam Bupropion: 100-450qam"
16246810|NCT01032018|Other|Standard care|Participants will receive standard of care from the current physicians
16246811|NCT01032005|Other|double fortified salt|Refined salt of particle size < 1 mm iodized with potassium iodate (KIO3) at a concentration of 30 µg I/g salt at the factory will be purchased and blended with encapsulated Ferrous Fumarate premix containing 15% iron. Premix to salt ratio of 1 to 150 will be used to arrive at 1000 ppm elemental iron in the final product.
16246812|NCT01031992|Drug|Tranexamic acid first, than placebo|For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
16246813|NCT01031992|Drug|First placebo, than Tranexamic acid.|First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.
16246814|NCT01031979|Drug|Yohimbine|alpha-2 adrenergic receptor antagonist
16246815|NCT01031979|Drug|Placebo|Placebo
16246816|NCT01031966|Biological|MF59 adjuvanted H1N1 influenza monovalent vaccine|One/two single administration
16246817|NCT01031966|Drug|Thymosin alpha 1|1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
16246818|NCT01031966|Drug|Thymosin alpha 1|1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
16246819|NCT01031953|Drug|fosaprepitant dimeglumine|A 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting.
16246820|NCT01031953|Drug|systemic chemotherapy|Patients will receive chemotherapy on Day 1 of their scheduled therapeutic regimen in combination with the pre-defined standard 5-Hydroxytryptamine-3 (5HT3) antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicated
16246821|NCT01031953|Other|survey administration|Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary
16246822|NCT01031953|Procedure|quality-of-life assessment|Patients will also be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero and then after 24 hours
16246823|NCT01031940|Device|macintosh laryngoscope|intubate with the macintosh laryngoscope
16246824|NCT01031940|Device|C-MAC laryngoscope|intubate with the C-MAC laryngoscope
16246825|NCT01031940|Device|Airtraq device|intubate with the Airtraq device
16246826|NCT01031927|Drug|N-methyl glycine|staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day
16246827|NCT01031914|Device|Paced Breathing|The Paced Breathing (PB) feature(when activated) will work to relax the user and help them fall asleep by encouraging them to take deep slow breaths until they reach 10 breaths (or less) per minute. The feature will also detect when the subject has fallen asleep so the Continuous Positive Airway Pressur (CPAP) device will automatically switch from PB mode to regular CPAP mode.
16246828|NCT01031901|Drug|Skincerity|Study subjects will apply a study product containing polyvinylidene fluoride coating alone to either facial angiofibromas or cutaneous neurofibromas
16246829|NCT01031901|Drug|Skincerity plus sirolimus/rapamycin|Study subjects will apply a study product containing polyvinylidene fluoride coating plus 1 mg of sirolimus/rapamycin to either facial angiofibromas or cutaneous neurofibromas
16246830|NCT01031901|Drug|Skinercity plus sirolimus/rapamycin|Study subjects will apply a study product containing polyvinylidene fluoride coating plus 5 mg of sirolimus/rapamycin to either facial angiofibromas or cutaneous neurofibromas
16246831|NCT01031888|Drug|Topical insulin eye drops|Regular insulin injection diluted to 100U/ml After the day of surgery, besides topical steroid, antibiotic and mydriatics, the patient receives topical insulin eye drops every two hours, except from 10pm to 8am, until the epithelial defect is totally closed
16246832|NCT01031888|Drug|Conventional postoperative eye drops|topical steroid, antibiotic and mydriatics
16246833|NCT01031875|Drug|pazopanib hydrochloride|
16246834|NCT01031875|Radiation|fludeoxyglucose F 18|
16246835|NCT01031862|Other|3H-Cholesterol|A single dose of 25-50 μCi 3H free cholesterol -albumin complexes (containing approximately 0.1 - 0.3 mg of cholesterol) will be administered intravenously as a slow bolus injection within 1-2 minutes.
16246836|NCT01031849|Drug|Kaletra|Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
16246837|NCT01031836|Drug|MEDI-545|"Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
~Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses."
16246838|NCT01031836|Drug|MEDI-545|"Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
~Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses"
16246839|NCT01031836|Drug|MEDI-545|"Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
~Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses."
16246840|NCT01031836|Drug|MEDI-545|"Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
~Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses."
16246841|NCT01031836|Drug|MEDI-545|"Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
~Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses"
16246842|NCT01031836|Drug|MEDI-545 600|"Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
~Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses."
16246843|NCT01031823|Behavioral|Multi-Media Social Skills Training Program|All individuals will participate in a twelve week social skills training program designed to enhance the social skills of adolescents with Asperger's Disorder or high-functioning autism. The intervention is comprised of both group therapy and peer generalization.
16246844|NCT01031810|Drug|tranylcypromine|MAO-Inhibitor 60mg-120mg
16246845|NCT01031784|Device|holmium-166 poly lactic acid microspheres|Intra arterial administration of radioactive Holmium 166 microspheres; 600 mg with a specific activity ranging from 1260 MBq per kilo liver weight to 5040 MBq in the highest dose
16246846|NCT01031784|Device|holmium 166 microspheres|intra arterial administration of holmium 166 microsphers in the hepatic artery
16246847|NCT01031758|Other|3H-Cholesterol|A single dose of 25-50 μCi 3H free cholesterol -albumin complexes (containing approximately 0.1 - 0.3 mg of cholesterol) will be administered intravenously as a slow bolus injection within 1-2 minutes.
16246848|NCT01031745|Behavioral|Contingency|Participants are provided a non-monetary incentive for achieving particular tasks between study visits. Tasks include initiation of HAART, timely refill of medications from the government ART centers, suppression of HIV RNA
16246849|NCT01031745|Other|Prize bowl drawings|"Control participants receive counseling and referral, but no incentives for engagement in HIV care. At study visits they are eligible to receive bonuses through prizebowl drawings to offset the inability to earn incentives."
16246850|NCT01031732|Procedure|MIS-2 THA|MIS two-incision THA
16246851|NCT01031732|Procedure|MIS-WJ|MIS-Watson Jones THA
16246852|NCT01031732|Procedure|MIS-AL THA|Transgluteal approach
16246853|NCT01031732|Procedure|MIS-PL THA|Posterolateral approach
16246854|NCT01031719|Biological|adjuvanted A(H1N1) influenza vaccine|7.5 ug of HA antigen; adjuvanted; monovalent
16246855|NCT01031719|Biological|non-adjuvanted A(H1N1) influenza vaccine|15ug of HA antigen, non-adjuvanted; trivalent
16246856|NCT01031719|Biological|non-adjuvanted A(H1N1) influenza vaccine|15 mcg of antigen; non-adjuvanted; trivalent
16246857|NCT01031706|Drug|Hypertonic Saline|inhaled HS (6% NaCl, 4mL) three times a day for 28 days
16246858|NCT01031706|Drug|Placebo|4 ml 0.12% NaCl inhaled three times a day x 28 days
16246859|NCT01031693|Device|Transcranial Magnetic Stimulation|daily sessions for 5 days
16246860|NCT01031680|Drug|Dapagliflozin|10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
16246861|NCT01031680|Drug|Placebo|Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
16246862|NCT01031667|Drug|Cilostazol, Probucol / placebo of probucol|An investigator-initiated, placebo-controlled, randomized, multi-center study. Enrolled patients will be randomized after PCI either to the combination therapy group or to the control group. In the combination therapy group, cilostazol 200 mg and probucol 500 mg will be administered daily, whereas the control group will receive cilostazol 200 mg daily only.
16246863|NCT01031628|Drug|Imatinib mesylate|400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
16246864|NCT01031628|Drug|Imatinib mesylate|600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
16246865|NCT01031628|Drug|Imatinib mesylate|400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
16246866|NCT01031615|Behavioral|Child and Family Traumatic Stress Interv (CFTSI)|4 sessions involving both the target child and a parent/caregiver
16246867|NCT01031615|Behavioral|Psychoeducational Comparison|4 individually focused sessions including psychoeducation and relaxation.
16246868|NCT01031602|Behavioral|Surveys|Surveys -- Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire completed at time of clinic appointment, taking about 20 minutes.
16246869|NCT01031589|Drug|TMC278 (Rilpivirine) LA; Placebo|
16246870|NCT01031550|Drug|isoflurane|isoflurane an anesthetic gas agent administered at specific times at a flow of 2 MAC
16246871|NCT01031550|Drug|propofol|standard of care
16246872|NCT01031537|Biological|FSME-IMMUN 0.5ml Baxter|Vaccine
16246873|NCT01031524|Biological|PfCS102|Antigen of the sporozoite protein
16246874|NCT01031524|Biological|Montanide ISA 720|adjuvant alone
16246875|NCT01031511|Behavioral|Cognitive Behavioural Therapy|16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
16246876|NCT01031511|Other|Social Recreational|16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists
16246877|NCT01031498|Drug|Ondansetron|8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
16246878|NCT01031498|Drug|Palonosetron|"Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy.
~Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy."
16246879|NCT01031485|Dietary Supplement|Milk peptides and plant sterols|
16246880|NCT01031485|Other|Placebo|
16246881|NCT01031472|Drug|GSK2248761 formulation 1|100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal)
16246882|NCT01031472|Drug|GSK2248761 reference formulation|GSK2248761 100mg Gelucire reference capsule with food
16246883|NCT01031472|Drug|GSK2248761 formulation 3|100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal)
16246884|NCT01031472|Drug|GSK2248761 formulation 2 or 4|100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal)
16246885|NCT01031459|Drug|Betaseron (Interferon beta-1b, BAY86-5046)|Telephone survey of all patients.
16246886|NCT01031446|Drug|cisplatin|Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.
16246887|NCT01031446|Drug|everolimus|Taken daily by mouth.
16246888|NCT01031446|Drug|paclitaxel|Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.
16246890|NCT01031420|Drug|single arm dose dense MVAC|standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
16246891|NCT01031394|Other|Frequency of Aerobic/Resistance Training - 3 to 3|comparing group results based upon frequency of exercise
16246892|NCT01031381|Drug|RAD001|RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
16246893|NCT01031381|Drug|bevacizumab|bevacizumab will be administered intravenously (IV) once every 14 days.
16246894|NCT01031368|Drug|cytarabine|Given IV
16246895|NCT01031368|Drug|clofarabine|Given IV
16246896|NCT01031368|Drug|filgrastim|Given SC
16246897|NCT01031368|Biological|Ex-vivo expanded cord blood progenitor cell infusion|Undergo ex vivo-expanded cord blood progenitor cell infusion
16246898|NCT01031368|Other|laboratory biomarker analysis|Correlative studies
16246899|NCT01031355|Drug|Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)|Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
16246900|NCT01031355|Drug|Estradiol Valerate (EV) (BAY86-4980)|Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
16246901|NCT01031355|Drug|Levomefolate Calcium (BAY86-7660)|Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
16246902|NCT01031342|Procedure|Early colonoscopy|Colonoscopy within 12 hours of presentation
16246903|NCT01031342|Procedure|Elective colonoscopy|Colonoscopy 36-60 hours after presentation
16246904|NCT01031329|Procedure|Tympanocenthesis and urine collection|Fluid using needle aspiration is obtained from middle ear fluid. Urine is collected using a urine bag.
16246905|NCT01031316|Other|Nondisclosure of screening echocardiogram results|Subjects will be randomized to nondisclosure of screening echocardiogram results.
16246906|NCT01031316|Other|Disclosure of screening echocardiogram results|Subjects will be randomized to disclosure of screening echocardiogram results.
16246907|NCT01031303|Biological|DTacP-IPV combined vaccine (TETRAXIM™)|0.5 mL, Intramuscular
16246908|NCT01031290|Device|Repetitive Transcranial Magnetic Stimulation|daily sessions for 5 days
16246909|NCT01031225|Drug|STA 9090|STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
16246910|NCT01031212|Drug|ASA404|Administered intravenously over 20 minutes weekly after chemotherapy
16246911|NCT01031212|Drug|Cetuximab|Administered at 400mg/m2 over 120 minutes on day -7 and then 250mg/m2 over 60 minutes weekly thereafter
16246912|NCT01031212|Drug|Carboplatin|Administered at fixed dose of AUC 6 intravenously on day 1 of each 3-week cycle
16246913|NCT01031212|Drug|Paclitaxel|Administered over 3 hours at a fixed dose of 175mg/m2 intravenously on day 1 of each 3-week cycle
16246914|NCT01031199|Drug|F-18 FEDAA1106 (BAY85-8101)|MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
16246915|NCT01031199|Drug|F-18 FEDAA1106 (BAY85-8101)|Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
16246916|NCT01031186|Drug|GSK356278|GSK356278
16246917|NCT01031186|Drug|PLACEBO|PLACEBO
16246918|NCT01031173|Biological|agalsidase alfa|0.2 mg/kg body weight, administered by an intravenous infusion over 40 minutes, every other week.
16246919|NCT01031147|Other|Examination|3D-TOF-MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography
16246920|NCT01031134|Behavioral|Shared Decision Making|Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
16246921|NCT01031134|Other|Usual Care|Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
16246922|NCT01031108|Drug|Placebo|"For the placebo product, SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
~Eight placebo capsules are stored in a dosing bottle and provided to all participating subjects for oral ingestion."
16246923|NCT01031108|Drug|SRT2104|SRT2104 investigational product is a size 00 Swedish Orange opaque hard gelatin capsule containing 0.25 g of SRT2104, a new chemical entity which is supplied as a micronized, yellowish/amber powder. Eight SRT2104 capsules are stored in a dosing bottle and provided to all participating subjects for oral ingestion.
16246924|NCT01031095|Other|coronary intervention|elective coronary intervention
16246925|NCT01031082|Procedure|Middle ear fluid, nasopharyngeal aspirate and urine sample.|Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
16246926|NCT01031069|Biological|GSK Biologicals' HPV vaccine 580299|Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
16246927|NCT01031069|Biological|Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)|Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
16246928|NCT01031056|Procedure|Blood Draw|
16246929|NCT01031056|Procedure|Frozen Tumor Specimens|
16246930|NCT01031043|Drug|Bethanechol|Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled.
16246931|NCT01031030|Drug|cyclophosphamide|
16246932|NCT01031030|Drug|epirubicin hydrochloride|
16246933|NCT01031030|Drug|fluorouracil|
16246934|NCT01031030|Drug|methotrexate|
16246935|NCT01031030|Other|laboratory biomarker analysis|
16246936|NCT01031030|Procedure|adjuvant therapy|
16246937|NCT01031017|Drug|progesterone|ovules, 200mg per vagina, once a day from 18 weeks
16246938|NCT01031017|Drug|placebo|placebo
16246939|NCT01031004|Device|narafilcon B|contact lens
16246940|NCT01031004|Device|etafilcon A|contact lens
16246941|NCT01030978|Behavioral|Bright Bodies Healthy Lifestyle Program|Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod.
16246942|NCT01030978|Behavioral|Control|Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.
16246943|NCT01030965|Drug|GSK573719 125mcg|125mcg once-daily
16246944|NCT01030965|Drug|GSK573719 250mcg|250mcg once-daily
16246945|NCT01030965|Drug|GSK573719 500mcg|500mcg once-daily
16246946|NCT01030965|Drug|Placebo|once-daily
16246947|NCT01030952|Drug|Nateglinide|Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
16246948|NCT01030952|Drug|Acarbose|Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
16246949|NCT01030939|Drug|SB-649868|In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo
16246950|NCT01030926|Drug|insulin degludec|0.4 U/kg body weight injected subcutaneously (under the skin), single dose
16246951|NCT01030926|Drug|insulin glargine|0.4 U/kg body weight injected subcutaneously (under the skin), single dose
16246952|NCT01030900|Biological|campath|campath plus EPOCH and rituximab every 3 weeks for up to 6 cycles
16246953|NCT01030900|Biological|Rituximab|rituximab plus EPOCH and campath every 3 weeks for up to 6 cycles
16246954|NCT01030900|Drug|EPOCH|EPOCH plus rituximab and campath every 3 weeks for up to 6 cycles
16246955|NCT01030887|Behavioral|Exercise programme|Moderate intensity exercise
16246956|NCT01030874|Other|Medication review|Current scheduled and as needed medications will be reviewed. Those medications with potentially hypotensive actions will be identified. There will be a joint review by Provider, Pharmacist, and Research staff of those medications and the patient's current clinical status. Plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).
16246957|NCT01030874|Other|Nutrition/Salt intake|Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to tray, or addition of salty foods/beverages (V8) will be considered as appropriate. Subjects receiving tube feedings will have water flushes replaced with saline flushes. Subjects with a history of congestive heart failure will be liberalized slowly and monitored closely by both the research and treatment team.
16246958|NCT01030874|Other|Education|The research intervention staff will review symptoms of OH with patient/family and explain pathophysiology using a standardized pt information handout (NINDS 2007), subjects will be encouraged to spend maximal time out of bed, and to ambulate on ward as much as possible.
16246959|NCT01030874|Other|Exercise|The patient's PT and/or Provider will review patient function for the ability to perform appropriate exercises and train patients (Ten Harkel, van Lieshout et al. 1994); (Bouvette, McPhee et al. 1996). Research staff will reinforce using these exercises while standing.
16246960|NCT01030874|Other|Drug Recommendations|The protocol permits the study physician to recommend medications for orthostatic hypotension. The patient's clinical team can implement, ignore, or modify these recommendations and only the clinical team can write orders for them. Fludrocortisone may be given 0.05mg at bedtime up to 0.2mg twice a day (Ten Harkel, Van Lieshout et al. 1992). Subjects with a history of congestive heart failure or peripheral edema will be carefully monitored. Sodium chloride tablets may be given starting at 1gm daily and increased to 2 gms twice daily [Mukai 2002; Grubb 2003]. Subjects with a history of congestive heart failure or peripheral edema will be carefully reviewed and monitored closely by the research staff and the treatment team. Midodrine may be given 2.5-5mg daily to three times daily [Low, 1997]. The dose will be started at 2.5mg every morning and then increased to 5mg every morning, then 5mg every morning and afternoon, then 5mg three times a day.
16246961|NCT01030861|Drug|Teplizumab|intravenous infusions
16246962|NCT01030861|Drug|Placebo infusion|Placebo for Teplizumab
16246963|NCT01030848|Device|Total Knee Replacement (LCS rotating platform)|
16246964|NCT01030822|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, administered as a single dose
16246965|NCT01030822|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, 3 doses
16246966|NCT01030809|Other|Treatment Algorithm for Crohn's Disease|Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.
16246967|NCT01030796|Behavioral|Caffeine abstinence|Brief instruction on beginning and maintaining caffeine abstinence.
16246968|NCT01030783|Drug|tivozanib (AV-951)|Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
16246969|NCT01030783|Drug|Sorafenib|Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
16246970|NCT01030770|Drug|Ranibizumab|Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls).
16246971|NCT01030770|Drug|0.9% Sodium Chloride|Single subconjunctival injection of 0.05mls of 0.9% w/v sodium chloride
16246972|NCT01030757|Radiation|Tomotherapy treatment|"A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
~Dose will be prescribed to the isodose line which covers at least 90% of the PTV
~Dose homogeneity +/- 5%"
16246973|NCT01030731|Drug|Ceftobiprole|Ceftobiprole 250mg single dose over 2 hours.
16247122|NCT01029652|Drug|Triamcinolone acetonide 40 mg|Triamcinolone acetonide 40 mg was supplied as a suspension.
16246974|NCT01030718|Drug|dasatinib|Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID
16246975|NCT01030692|Drug|Placebo|The placebo groups will receive the same dosage throughout the study.
16246976|NCT01030692|Drug|Rivastigmine 3 mg|The 3 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-9, and 3 mg in the morning of Day 10.
16246977|NCT01030692|Drug|Huperzine A 0.4 mg|The 0.4 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-9, and 0.2 mg in the morning of day 10.
16246978|NCT01030692|Drug|Rivastigmine 6 mg|The 6 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-5, 3 mg in the morning and evening of Days 6-9, and 3 mg in the morning of Day 10.
16246979|NCT01030692|Drug|Huperzine A 0.8 mg|The 0.8 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-5, 0.4 mg in the morning and evening of Days 6-9, and 0.4 mg in the morning of Day 10.
16246980|NCT01030679|Drug|CKD-501 0.5mg|0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
16246981|NCT01030679|Drug|CKD-501 1mg|1 mg/tablet, orally, 1 tablet once daily for 8 weeks
16246982|NCT01030679|Drug|CKD-501 2mg|2 mg/tablet, orally, 1 tablet once daily for 8 weeks
16246983|NCT01030679|Drug|Placebo|orally, 1 tablet once daily for 8 weeks
16246984|NCT01030666|Drug|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects.
16246985|NCT01030666|Drug|Placebo|The patients of the doxycycline group will take 200 mg placebo once a day for 7 days after regenerative therapy of an infrabony defects.
16246986|NCT01030666|Procedure|modified/simplified papilla preservation flap; scaling|Following an intra-crevicular incision a mucoperiosteal flap was reflected to a height of 5 mm exposing the bony margin of the defect and allowing complete visualization of the infrabony lesion. The flap was designed according to the modified or simplified papilla preservation technique to obtain primary closure of the wound and the membrane respectively. The flap was extended at least one tooth mesially and distally of the defect side. After complete removal of inflammatory granulation tissue, the root surfaces were thoroughly scaled and root planed.
16246987|NCT01030666|Biological|Prefgel/Emdogain|When using EMD the root surfaces facing the infrabony defect were conditioned with EDTA (prefgel; Institut Straumann AG, Basel, Switzerland) for 2 min. first. Then the EDTA was washed out with plenty of saline. After drying the surfaces EMD was applied starting at the bottom of the defect and proceeding coronally.
16246988|NCT01030666|Drug|0.12% chlorhexidine gluconate solution|Furthermore, all patients were advised to rinse with a 0.12% chlorhexidine gluconate solution (ParoEx; Butler, Kriftel, Germany) for 2 min. twice daily for 5-7 weeksafter surgery.
16246989|NCT01030666|Drug|Ibuprofen 400 mg (if necessary)|400 mg ibuprofen qd was prescribed for patient's comfort if necessary.
16246990|NCT01030666|Drug|1% chlorhexidine gluconate gel (if necessary)|If soft tissue dehiscence was noted the patient was advised to use a 1% chlorhexidine gluconate gel (Chlorhexamed 1% Gel; GlaxoSmithKline, Bühl, Germany) twice daily
16246991|NCT01030653|Drug|Voriconazole low dose|Voriconazole 400 mg po x 2 doses (loading dose)then 200 mg po twice daily x 7 doses
16246992|NCT01030653|Drug|Voriconazole high dose|Voriconazole 400 mg po x 2 doses (loading dose)then 300 mg po twice daily x 7 doses
16246993|NCT01030640|Other|placebo|single dose of the drug formulation
16246994|NCT01030640|Biological|tanezumab|single dose of the active drug tanezumab at a dose level of 20 mg
16246995|NCT01030627|Device|Springfusor infusion pump|Women will receive a loading dose and maintenance therapy using an IV infusion administered by the Springfusor® pump. Women will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4 will be administered using the Springfusor® pump. The administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. The pump will be started immediately after the initial bolus and the 4g dose repeated (and syringe replaced) every four hours. Maintenance therapy will be administered for at least 24h. Treatment will be discontinued when clinically indicated. Drug administration will be initiated at the sites and, when necessary, the patient will be transferred, with the Springfusor pump in situ, to the local referral site.
16246996|NCT01030614|Drug|Dexamethasone|intravenous dexamethasone 8 mgr before laparoscopic cholecystectomy or intravenous placebo before laparoscopic cholecystectomy
16246997|NCT01030614|Drug|placebo|One hundred five patients were randomized to receive intravenous placebo before laparoscopic cholecystectomy
16246998|NCT01030601|Drug|Dexamethasone sodium phosphate|0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial
16246999|NCT01030575|Drug|Inositol lower volume|5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes
16247000|NCT01030575|Drug|Inositol mid-level volume|20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes
16247001|NCT01030575|Drug|Inositol high volume|40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes
16247002|NCT01030575|Drug|Placebo low volume|Glucose 5% given in volumes equal to that of the comparator drug
16247003|NCT01030536|Drug|CAT-8015 20 mcg/kg|Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
16247004|NCT01030536|Drug|CAT-8015 30 mcg/kg|Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
16247005|NCT01030536|Drug|CAT-8015 40 mcg/kg|Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
16247006|NCT01030536|Drug|CAT-8015 50 mcg/kg|Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
16247007|NCT01030536|Drug|CAT-8015 60 mcg/kg|Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
16247008|NCT01030523|Device|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
16247009|NCT01030523|Device|ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)|ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
16247010|NCT01030510|Drug|the order of drug administration|In group R, remifentanil was infused first before administrating propofol and rocuronium and in group P, it was administered last after the rocuronium injection. In other words, the order of drug infusion in each group is remifentanil-propofol-rocuronium in group R and propofol-rocuronium-remifentanil in group P, respectively.
16247011|NCT01030471|Behavioral|Family-based cognitive-behavioral treatment|Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.
16247012|NCT01030458|Drug|amlodipine 5/10 mg per day plus valsartan 160 mg/day|Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
16247013|NCT01030458|Drug|hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day|hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
16247014|NCT01030432|Drug|BMS-650032|Tablets, Oral, 200 mg, Twice Daily, 48 weeks
16247015|NCT01030432|Drug|BMS-650032|Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
16247016|NCT01030432|Drug|Placebo|Tablets, Oral, 0 mg, twice daily, 48 weeks
16247017|NCT01030432|Drug|Placebo|Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
16247018|NCT01030432|Drug|Placebo|Tablets, Oral, 0 mg, twice daily 24 weeks
16247019|NCT01030432|Drug|Peginterferon Alfa-2a|Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
16247020|NCT01030432|Drug|Peginterferon Alfa-2a|Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
16247021|NCT01030432|Drug|Ribavirin|Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
16247022|NCT01030432|Drug|Ribavirin|Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
16247023|NCT01030419|Behavioral|Home-based, DVD-delivered physical activity|Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week. Additionally, they will be encouraged to add two days of aerobic activity (e.g. walking) each week.
16247024|NCT01030419|Behavioral|Usual care/Wait list|Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD afer the completion of the 12-month follow-up testing.
16247025|NCT01030406|Drug|40/0mg taken first|8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
16247026|NCT01030406|Drug|80/0mg taken first|8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
16247027|NCT01030406|Drug|40/240mg taken first|8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
16247028|NCT01030406|Drug|80/480mg taken first|8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
16247029|NCT01030406|Drug|0/0mg taken first|Placebo All arms taken with a 48 hour washout between doses
16247030|NCT01030393|Drug|human chorionic gonadotrophin|intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
16247031|NCT01030380|Device|Slendertone Face|Slendertone Face 20 minutes/day, 5 days/week for 12 weeks.
16247032|NCT01030367|Drug|PETN, ISDN|Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
16247033|NCT01030354|Dietary Supplement|Herbalife Meal Replacements|Higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass will improve weight loss in comparison to a standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass
16247034|NCT01030354|Dietary Supplement|Herbalife Meal Replacements|Higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass will improve weight loss in comparison to a standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass.
16247035|NCT01030341|Device|CGMS and insulin pump|Use of continuous glucose monitoring system and insulin pump
16247036|NCT01030328|Drug|Placebo|2 sugar pills by mouth once a day.
16247037|NCT01030328|Drug|TriLipix|135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
16247038|NCT01030315|Drug|HM10760A or placebo|Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
16247039|NCT01030302|Drug|bortezomib|bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
16247040|NCT01030289|Device|real tDCS|transcranial direct current stimulation
16247041|NCT01030289|Device|sham tDCS|transcranial direct current stimulation
16247042|NCT01030276|Other|Bright light therapy|Bright light therapy
16247043|NCT01030276|Other|"Inactive placebo-light"|In this arm, patients will not get any bright-light therapy in a double-blind setting
16247044|NCT01030263|Other|Fluorescence-aided confocal endomicroscopy guided biopsy.|Fluorescence-aided confocal endomicroscopy guided biopsy.
16247045|NCT01030263|Other|Random four-quadrant biopsies.|Random four-quadrant biopsies.
16247046|NCT01030237|Other|FID 114657|1 drop both eyes four times a day for 6 weeks
16247047|NCT01030237|Other|Soothe XP Lubricant Eye Drops|1 drop both eyes four times a day for 6 weeks
16247048|NCT01030224|Drug|AZD9742|Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee
16247049|NCT01030224|Drug|Placebo to match AZD9742|Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)
16247050|NCT01030211|Procedure|Platelet transfusion|4 units of platelets for patients with platelet count <20x10^3/uL
16247051|NCT01030211|Other|Supportive care|Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure
16247052|NCT01030198|Device|RevLite (Laser Treatment)|
16247123|NCT01029652|Drug|Placebo to canakinumab|Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
16247399|NCT01027442|Device|Dental Implants|Dental implants placed via conventional free-hand method
16247053|NCT01030185|Device|NovaShunt's Automated Fluid Shunt implantation|The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.
16247054|NCT01030159|Other|Adult Cancer Patients|Tracking anemia management in Adult Cancer Patients
16247055|NCT01030146|Drug|NeilMed® Sinus Rinse™ System with Isotonic Saline|NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day
16247056|NCT01030133|Device|Operator Role Real TMS|"In two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The operator's performance will control the painfulness delivered to both participants. Each participant will play each role twice."
16247057|NCT01030133|Device|Receiver Role Real TMS|"In two of the four visits, the participant will be assigned to the receiver condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The receiver's performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice."
16247058|NCT01030133|Device|Operator Role Sham TMS|"In two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The operator's performance will control the painfulness delivered to both participants. Each participant will play each role twice."
16247059|NCT01030133|Device|Receiver Role Sham TMS|"In two of the four visits, the participant will be assigned to the receiver condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The receiver's performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice."
16247060|NCT01030133|Device|All Participants Operator Role|All participants in Operator Role (Receiving real or sham TMS)
16247061|NCT01030120|Drug|etanercept|etanercept 50mg BIW S.Q.
16247062|NCT01030120|Drug|placebo|placebo
16247063|NCT01030107|Behavioral|Increase Sleep|Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.
16247064|NCT01030107|Behavioral|Decrease Sleep|Children are asked to decrease their sleep by approximately 1 1/2 hours/night.
16247065|NCT01030094|Drug|Topiramate|This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.
16247066|NCT01030094|Drug|Carbamazepine|This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.
16247067|NCT01030094|Drug|Valproic acid|This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.
16247068|NCT01030094|Drug|Normal control|This is an observational study. Healthy female participants will be observed in Normal control group.
16247069|NCT01030081|Drug|Amlodipine (Norvasc®)|Amlodipine (Norvasc®), tablet, 5 mg
16247070|NCT01030081|Drug|Nifedipine GITS (Adalat® XL 30|Nifedipine GITS (Adalat® XL 30), controlled released tablet, 30 mg
16247071|NCT01030068|Behavioral|Yoga|Yoga twice weekly
16247072|NCT01030068|Behavioral|Wellness|Health and wellness classes twice weekly
16247073|NCT01030068|Other|Smoking cessation therapy|Smoking cessation therapy
16247074|NCT01030055|Drug|TKI258 (dovitinib)|bioavailability (anhydrate capsules) food (monohydrae capsules)
16247075|NCT01030042|Drug|FOLFOX-4|Day 1: OXA will be administered as a 85 mg/m2 iv infusion over 2 hours; Leucovorin as a 100 mg/m2 infusion over 2 hours, 5-FU will be given as a 400 mg/m2 bolus injection, and then as a 600 mg/m2 continuous infusion over 22 hours after the first infusion Day 2: Leucovorin 100 mg/m2 (alone), followed by 5-FU 400 mg/m2 bolus injection, and 5-FU 600 mg/m2 continuous infusion after the first infusion Cycle length is 2 weeks comprising approximately 48 hours of infusion and 12 days of rest. Cycles are to be repeated every second week for a total of either 6 (12 weeks) or 12 cycles (24 weeks).
16247076|NCT01030042|Drug|Irinotecan/Cetuximab|"CET 400 mg/m2 intravenously via infusion pump given over a 120 min time and weekly CET infusions at a maintenance dose of 250 mg/m2 given over a 60 min time.
~IRI 180 mg/m2 iv infusion over 30-90 min. Cycle length is 2 weeks and it is to be repeated until disease progression."
16247077|NCT01030029|Device|electrical auricular acupuncture|Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point [2]. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.
16247078|NCT01030029|Device|P-Stim™ devices were applied without electrical stimulation and acupuncture.|Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.
16247079|NCT01030016|Drug|atenolol|25 mg/day, twice a day for 6 weeks
16247080|NCT01029990|Other|Telephone arm|Midwifes at 72 antenatal care units in West region of Sweden receive lists with names and telephone numbers on women who have no record of screening during two screening rounds (6 - 10 years depending on age). The midwife will make up to ten attempts to reach each woman and is instructed to use no more than 30 minutes on this. If the midwife get in touch with the woman she will encourage participation in regular screening (run by midwives in Sweden) and help the woman to get an appointment.
16247124|NCT01029652|Drug|Placebo to triamcinolone acetonide|Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
16247081|NCT01029990|Other|Self-test arm|Women receive an offer to order a vaginal self test for HPV. The woman can return a coupon in a postage free envelope and she will receive a self testing kit (dry method) within a couple of days. She will return the test in another postage free envelope. A reminder will be sent to women who order a test but do not return it.
16247082|NCT01029964|Behavioral|Individually and in groups|During three year in a clinical setting.
16247083|NCT01029951|Procedure|manipulation|
16247084|NCT01029951|Procedure|Mobilisation|
16247085|NCT01029951|Device|Activator instrument|
16247086|NCT01029938|Procedure|Covered stent|Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
16247087|NCT01029938|Procedure|Coil|Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
16247088|NCT01029925|Drug|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart
16247089|NCT01029912|Device|Electrical stimulator|"6-week intervention
~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.
~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
16247090|NCT01029886|Drug|exenatide once weekly|subcutaneous injection, 2mg, once weekly
16247091|NCT01029886|Drug|liraglutide|subcutaneous injection, forced titration to 1.8mg, once daily
16247092|NCT01029873|Drug|Cisplatin|Intravenous infusions; 2 treatment courses; 2 treatment cycles for each course; 70mg/m2 on day 1 of cycle 1 for each course
16247093|NCT01029873|Biological|ALT-801|"Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses
~Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg)
~Stage 2: dose expansion (dose at MTD)"
16247094|NCT01029847|Drug|Adalimumab|Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
16247095|NCT01029847|Drug|Placebo|"sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6.
~At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines."
16247096|NCT01029834|Behavioral|family based lifestyle and behavioral counseling|16 group meetings
16247097|NCT01029834|Behavioral|counseling focused on the child|16 meetings
16247098|NCT01029821|Drug|Low-Molecular-Weight Heparin|Isolated Ankle Fracture Single planned operation
16247099|NCT01029795|Drug|LY2599506|Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks
16247100|NCT01029795|Drug|Glyburide|Administered po, BID daily prior to morning and evening meals for 12 weeks
16247101|NCT01029795|Drug|Placebo|Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks
16247102|NCT01029782|Drug|IV cefazolin plus oral probenecid and placebo cephalexin|Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
16247103|NCT01029782|Drug|Oral cephalexin and saline IV plus probenecid placebo|Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
16247104|NCT01029769|Drug|Olanzapine or amisulpride|Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding
16247105|NCT01029756|Device|Macintosh Laryngoscope|Device used to gain a direct view of the vocal cords, to enable an endotracheal tube to be passed into the trachea at induction of anaesthesia.
16247106|NCT01029756|Device|Pentax AWS Videolaryngoscope|Self-contained video laryngoscope with an integral colour-viewing screen mounted on the handle. A camera at the tip transmits an indirect image, which obviates the need to obtain a direct view of the vocal cords, when passing an endotracheal tube on induction of anaesthesia.
16247107|NCT01029743|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended
16247108|NCT01029743|Drug|Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)|Daily dose, dosage frequency and duration will be decided by physicians
16247109|NCT01029730|Drug|Bendamustine|Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
16247110|NCT01029730|Drug|Bortezomib|Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
16247111|NCT01029730|Drug|Rituximab|Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
16247112|NCT01029717|Device|Standard polyurethane Central Venous Catheter|Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.
16247113|NCT01029717|Device|Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)|Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
16247114|NCT01029717|Device|Heparin bonded polyurethane CVC|Heparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
16247115|NCT01029704|Drug|EGT0001442|"Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
~Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days."
16247116|NCT01029704|Drug|Placebo capsules to match EGT0001442|"Segment 1: Not applicable.
~Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days."
16247117|NCT01029691|Device|Positive Airway Pressure|Women will use positive airway pressure until delivery
16247118|NCT01029678|Drug|Cisplatin IV|Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
16247119|NCT01029678|Drug|Vinorelbine|Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
16247120|NCT01029678|Radiation|Radiotherapy|66Gy, 33 fractions, 6 week
16247121|NCT01029652|Drug|Canakinumab 150 mg|Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
16247125|NCT01029639|Procedure|Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)|Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
16247126|NCT01029626|Procedure|Endoscopy|Realization of an upper GI endoscopy
16247127|NCT01029613|Drug|Adalimumab|sc. inj. Humira 40 mg every other week from week 0 to 52
16247128|NCT01029600|Procedure|Arthroscopic capsular release|Surgical division of thickened capsule in the shoulder
16247129|NCT01029600|Procedure|Distention with steroid|Intraarticular distention with steroid, saline, contrast and local anaesthetic
16247130|NCT01029587|Drug|Eculizumab|Eculizumab will be administered by intravenous infusion. Eculizumab will be administered at a dose of 1200mg by intravenous (IV) infusion on the day of or on the day prior to kidney transplantation, and at a dose of 900mg IV on post-operative day 1. Subsequently, the post-operative dosing regimen would be comprised of an induction phase of weekly doses of 900mg IV per dose followed by a maintenance phase of every other week dosing of 1200mg IV per dose. The weekly induction dosing regimen would begin on postoperative day 8, and would continue for three doses (specifically, doses of 900mg IV would be given on postoperative days 8, 15, and 22). The maintenance phase of dosing would begin with a dose of 1200mg on postoperative day 29, and would continue for a total of 5 doses (specifically, doses of 1200mg IV would be given on postoperative days 29, 43, 47, 72, and 85). In most cases, eculizumab would be discontinued after the 5th maintenance dose.
16247131|NCT01029574|Other|Platelet rich plasma|Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
16247132|NCT01029561|Device|CPAP|Treatment with Continuous Positive Airway Pressure
16247133|NCT01029561|Behavioral|Diet|Conventional diet treatment that undergo patients in the Bariatric Surgery Program
16247134|NCT01029535|Device|Cross-linked hyaluronic acid gel|Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.
16247135|NCT01029522|Drug|Atorvastatin (Lipilou)|treatment of dyslipidemia administration : PO, qod
16247136|NCT01029522|Drug|Atorvastatin (Lipitor)|treatment of dyslipidemia administration : PO, qod
16247137|NCT01029509|Drug|OPB 31121|Starting dose of 200 mg (two 100 mg tablets) twice a day for 21 days followed by 7 days of rest.
16247138|NCT01029496|Procedure|different time of umbilical cord clamping|"for normal birth(apgar score over 7),include:term ,preterm,normal birth or cesarean section : experimental group1: waiting until the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen.
~control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
~for in case of asphyxia(regardless term or preterm,normal birth or cesarean section born):
~experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing.
~control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table."
16247139|NCT01029483|Other|Low carbohydrate diet|Ad libitum low carbohydrate diet (<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.
16247140|NCT01029483|Other|High-carbohydrate ad libitum intervention|Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired
16247141|NCT01029483|Other|High carbohydrate diet-energy matched intervention|Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at ~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.
16247142|NCT01029470|Drug|Luveris|Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
16247143|NCT01029444|Procedure|Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )|Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment RQ levels and their insulin resistance.
16247144|NCT01029431|Device|AirQ Intubating Laryngeal Airway|After induction of anaesthesia in each child, either a PLMA or an Air-Q® ILA of the weight-appropriate size will be inserted & the evaluation described below will be conducted. The first LMA will then be removed & the other device inserted & assessed. The order in which the LMA devices are inserted will be determined using block randomisation, with random block sizes, after recruitment & before induction of anesthesia. The anesthesiologist will insert the LMAs using the manufacturer's recommended technique, & inflate the cuff to the manufacturer's recommended intracuff pressure of 60 cm H2O. Intracuff pressure will be measured with a digital pressure cuff monitor.
16247145|NCT01029418|Drug|AZD6244 and sorafenib|dose escalation of AZD6244; sorafenib 400mg bd
16247146|NCT01029405|Drug|AN2728|Ointment B, 2% or 0.5% applied once or twice daily
16247147|NCT01029405|Drug|Placebo|Ointment B Vehicle applied once or twice daily
16247148|NCT01029392|Drug|Vitamin D|2000iu once a day
16247149|NCT01029366|Biological|CART-19|Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
16247150|NCT01029353|Procedure|Laparotomy|Initial laparotomy will be performed. Standard procedures will be used, including inspection of the bowel with removal of diseased areas, creation of stoma(s), and other procedures deemed indicated by the surgeon.
16247151|NCT01029353|Procedure|Drainage|Initial drainage will involve placing a Penrose drain in the abdomen.
16247152|NCT01029340|Biological|Recombinant Factor VIII (BAY81-8973)|Single dose of BAY81-8973 crossed over to single dose of Kogenate FS
16247153|NCT01029340|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Single dose of Kogenate FS crossed over to Single dose of BAY81-8973
16247154|NCT01029340|Biological|Recombinant Factor VIII (BAY81-8973)|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
16247155|NCT01029340|Biological|Recombinant Factor VIII (BAY81-8973)|Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
16247156|NCT01029301|Device|Device: EndyMed Pro System for Skin Tightening|"Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed):
~Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening);"
16247157|NCT01029288|Other|Diabetes Medication Choice Decision Aid|Diabetes Medication Choice cards
16247158|NCT01029288|Other|Statin Choice Decision Aid|Statin Choice Cards
16247159|NCT01029288|Other|Usual care for lipid therapy medication|Clinicians will follow their clinic's usual care practice for lipid therapy medication (statin) discussions.
16247160|NCT01029288|Other|Usual care for antihyperglycemic medication|Clinicians will follow their clinic's usual care practice for antihyperglycemic medication discussions.
16247161|NCT01029275|Drug|Pre-treatment with octreotide|Pre-treatment with octreotide
16247162|NCT01029262|Drug|Lenalidomide|One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
16247163|NCT01029262|Other|Placebo|3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
16247164|NCT01029236|Other|Medifast Metabolism-boosting Beverages|Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.
16247165|NCT01029223|Drug|ivabradine|
16247166|NCT01029223|Drug|metoprolol|
16247167|NCT01029223|Drug|placebo|
16247168|NCT01029197|Behavioral|CBT and exposure therapy for PTSD|The CBT intervention will be administered twice weekly in group therapy sessions for 7 weeks, and then twice weekly individual sessions for 4 weeks.
16247169|NCT01029197|Other|Treatment as Usual|Participants in the treatment as usual condition will receive their usual services at the community clinic where they receive mental health and substance abuse services
16247170|NCT01029184|Other|commercialized complete cereals|complete cereals suitable for the weaning period
16247171|NCT01029184|Other|commercialized complete cereals with additional ingredient|complete cereals suitable for weaning period
16247172|NCT01029171|Behavioral|Home-based balance and strength retraining exercise program.|A 12-month home-based balance and strength restraining program delivered by a physical therapist
16247173|NCT01029171|Behavioral|control; usual care|Usual care as prescribed by geriatrician.
16247174|NCT01029158|Drug|Juvista (Avotermin)|250 ng, twice, intradermal injection, standard formulation
16247175|NCT01029158|Drug|RN1006 (Avotermin)|250 ng, intradermal injection, twice
16247176|NCT01029158|Drug|RN1006 (Avotermin)|205 ng, Intradermal injection, once
16247177|NCT01029158|Drug|RN1006 (Avotermin)|500ng, intradermal injection, once
16247178|NCT01029158|Drug|Juvista (Avotermin)|250 ng, intradermal injection, twice
16247179|NCT01029158|Drug|Juvista (Avotermin)|500 ng, intradermal injection, once
16247180|NCT01029158|Drug|Juvista (Avotermin)|500 ng, intradermal injection, once
16247181|NCT01029158|Drug|RN1006 (Avotermin)|500 ng, intradermal injection, twice
16247182|NCT01029158|Drug|Placebo|Placebo
16247183|NCT01029132|Drug|galantamine|8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
16247184|NCT01029106|Procedure|Gynecare TVT Secur|Implant of the Gynecare TVT Secur
16247185|NCT01029093|Other|no intervention, MRI and motor skill test|Two MR Investigations at two different times
16247186|NCT01029080|Other|no interventions|No interventions
16247187|NCT01029067|Behavioral|Metacognitive training|Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level
16247188|NCT01029067|Behavioral|Cognitive Remediation|Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level
16247189|NCT01029054|Drug|carfilzomib, lenalidomide plus dexamethasone|"Phase I: Carfilzomib will be administered at the dosage assigned for the subject's cohort as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
~Dexamethasone 40 mg will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
16247190|NCT01029054|Drug|carfilzomib, lenalidomide plus dexamethasone|"Phase II: Carfilzomib will be administered at the Maximum Tolerated Dose (MTD) established in Phase I as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).
~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.
~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push on Days 1, 8, 15, and 22 as follows: Cycles 1-4: 40 mg; Cycles 5-8: 20 mg; and Cycles 9 and higher: 10 mg."
16247191|NCT01029041|Other|Strengthening Exercises|Exercises that aim the improvement of muscular strength of arms and legs
16247192|NCT01029041|Other|Stretching exercises|Exercises that aim the improvement of muscular flexibility of arms, legs and spine
16247193|NCT01029015|Procedure|cystometry|recording device measuring pressures though catheters placed in bladder and rectum
16247194|NCT01029015|Procedure|polysomnography|recording device measuring sleep activity through electrodes attached to the subject
16247195|NCT01029002|Drug|Vitamin D|Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
16247196|NCT01029002|Other|Placebo|Patients randomized to this arm will receive one placebo pill once weekly.
16247317|NCT01028118|Other|Identifying experience with violence|Asking about life experience with violence and Cognitive Behavior Therapy.
16247197|NCT01028989|Dietary Supplement|Reduced Glycemic Load Diet|"36-40% fat; 40-42% carbohydrate; 18-22% protein
~Glycemic Load <=46 per 1000 calories"
16247198|NCT01028989|Dietary Supplement|Standard Diet|"25-27% fat; 55-57% carbohydrate; 18-22% protein
~Glycemic Load >=77 per 1000 calories"
16247199|NCT01028976|Dietary Supplement|Vitamin C (ascorbic acid)|1000 mg/day (two 500-mg tablets), 8 weeks
16247200|NCT01028976|Dietary Supplement|Placebo tablet|Placebo tablet (two 500-mg tablets), 8 weeks
16247201|NCT01028963|Drug|Placebo|Placebo capsules once daily
16247202|NCT01028963|Drug|pioglitazone|pioglitazone 30 mg tablet once daily
16247203|NCT01028963|Drug|CCX140-B|CCX140-B capsules once daily (Group C)
16247204|NCT01028963|Drug|CCX140-B|CCX140-B capsules once daily (Group D)
16247205|NCT01028950|Drug|YM150|oral
16247206|NCT01028937|Device|Optimal Keratoplasty|Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot
16247207|NCT01028924|Drug|Teduglutide|subcutaneous (SC), single dose
16247208|NCT01028911|Drug|PF-03654746|PF-03654746 capsule of 0.25 mg, 0.5 mg, and 1.0 mg strength. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.
16247209|NCT01028911|Drug|Placebo|"Matching placebo capsules to PF-03654746 with strengths of 0.25 mg, 0.5 mg, and 1.0 mg.
~Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator."
16247210|NCT01028885|Procedure|radiation therapy treatment planning/simulation|
16247211|NCT01028885|Procedure|intensity-modulated radiation therapy|
16247212|NCT01028885|Procedure|image-guided radiation therapy|
16247213|NCT01028885|Procedure|magnetic resonance imaging|
16247214|NCT01028885|Procedure|computed tomography|
16247215|NCT01028872|Device|Intraocular lens|
16247216|NCT01028872|Device|Intraocular lens|
16247217|NCT01028872|Device|Intraocular lens|
16247218|NCT01028859|Drug|CKD-516 inj|5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks
16247221|NCT01028833|Other|Power mobility|Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
16247222|NCT01028820|Drug|Aripiprazole|8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily
16247223|NCT01028807|Other|Early feeding|after 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated.
16247224|NCT01028807|Other|5 day fasting|Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.
16247225|NCT01028794|Biological|autologous bone marrow mononuclear cells|intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)
16247226|NCT01028794|Biological|autologous bone marrow mononuclear cells|intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)
16247227|NCT01028781|Drug|Thalidomide|Pill form, 50mgs with increasing dosage up to a maximum of 250 mg qd based on pain reports, taken once daily for 14-16 weeks with one 6 month follow-up appointment.
16247228|NCT01028768|Drug|Teduglutide|10 mg, one-time subcutaneous
16247229|NCT01028755|Drug|BAY79-4620|BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities
16247230|NCT01028729|Drug|Endostar|7.5mg/m2/day, iv, from day 1 to day 14
16247231|NCT01028729|Drug|Gemcitabine-Cisplatin chemotherapy|Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
16247232|NCT01028716|Drug|Cyclophosphamide|Given IV
16247233|NCT01028716|Biological|Filgrastim|Given IV
16247234|NCT01028716|Drug|Fludarabine Phosphate|Given IV
16247235|NCT01028716|Procedure|Laboratory Biomarker Analysis|Correlative studies
16247236|NCT01028716|Drug|Mycophenolate Mofetil|Given PO
16247237|NCT01028716|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo PBSC
16247238|NCT01028716|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC
16247239|NCT01028716|Drug|Tacrolimus|Given IV or PO
16247240|NCT01028716|Radiation|Total-Body Irradiation|Undergo total-body irradiation (TBI)
16247241|NCT01028716|Drug|Fludarabine|Given IV
16247242|NCT01028690|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475; will be delivered at a dose of 1x108 CFU of each strain. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Will be taken daily throughout the entire study, from the day of inclusion to the final analysis at the end of follow-up after eradication therapy. Will be delivered either in a chewable tablet form
16247243|NCT01028690|Dietary Supplement|Placebo|placebo
16247244|NCT01028677|Drug|intranasal spray with oxytocin|6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
16247245|NCT01028677|Other|nasal spray without oxytocin|6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
16247246|NCT01028664|Device|SENSIMED Triggerfish|2-hour continuous IOP monitoring
16247318|NCT01028105|Other|Preoperative MRSA screening|MRSA preoperative screening and post operative infection rate, 30 days post operative
16247247|NCT01028651|Drug|Treprostinil|"Remodulin is supplied in concentrations of 1, 2.5 , 5, and 10 mg/mL and can be administered as supplied or diluted for intravenous (IV) infusion prior to administration.
~Remodulin is indicated for subcutaneous (SC) or IV use only as a continuous infusion. Remodulin is preferably infused subcutaneously, but can be administered by a central IV line if the SC route is not tolerated. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, the infusion rate should be reduced to 0.625 ng/kg/min."
16247248|NCT01028638|Other|89Zr-bevacizumab PET scan|"A tracer dose of 89Zr-bevacizumab (37 MBq, 5 mg protein dose) is given intravenously at day -3, day 11 and day 39.
~PET scans are made on day 1, day 15 and day 43."
16247249|NCT01028625|Behavioral|Cognitive Behavior Therapy|CBT utilizes a variety of strategies and techniques to modify cognitions and behaviors that contribute to depression such as behavioral activation; identifying and challenging distressing thoughts, beliefs, and attitudes; and systematic problem-solving. In this trial, CBT will be integrated with an intervention aimed at improving heart failure self-care, and with attention to primary caregiver stress. The CBT sessions will usually last about 50 minutes and will be scheduled weekly for up to 6 months, with additional maintenance contacts after that. The frequency of sessions will be tapered prior to 6 months if the participant meets the study criteria for depression remission and has acquired relapse-prevention skills.
16247250|NCT01028625|Other|Heart Failure Self-care Education|Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls.
16247251|NCT01028612|Radiation|thermal ablation with external beam radiation|thermal ablation with external beam radiation
16247252|NCT01028599|Other|Intensive physical exercise|Intensive physical exercise 1 hour three times per week
16247253|NCT01028586|Drug|Safinamide, MAO-B inhibitor|Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
16247254|NCT01028586|Drug|Safinamide, MAO-B inhibitor|Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
16247255|NCT01028586|Drug|Placebo|matching placebo tablets
16247256|NCT01028573|Drug|PEG-ELS (Golytely)|4L consumed evening before colonoscopy
16247257|NCT01028573|Drug|PEG-ELS (Golytely)|2L consumed on the evening before and 2L consumed on the morning of Colonoscopy
16247258|NCT01028573|Drug|Miralax mixed with Gatorade|238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy
16247259|NCT01028573|Drug|Miralax|1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy
16247260|NCT01028560|Biological|Allergen extracts (subcutaneous injections)|Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-2 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety, the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase (year 2-3)
16247261|NCT01028560|Other|Standard of care|standard of care asthma and allergy treatment
16247262|NCT01028547|Drug|dexamethasone|single Bolus dose of dexamethasone 8mg
16247263|NCT01028547|Other|normal saline|2 ml 0.9% saline
16247264|NCT01028534|Drug|Olmesartan and Azelnidipine|"Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months
~Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months
~Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months"
16247265|NCT01028521|Drug|CM3.1-AC100|Solution for sc injection, single ascending doses
16247266|NCT01028521|Drug|Placebo|Solution for sc injection
16247267|NCT01028508|Drug|lithium and Venlafaxine|Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
16247268|NCT01028508|Procedure|ECT|Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
16247269|NCT01028495|Drug|RX-0201 plus Gemcitabine|RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.
16247270|NCT01028482|Drug|Sertraline|"group A- sertraline 50-100 mg/day and weekly psychotherapy for 3 months
~group B- weekly psychotherapy- for 3 months
~group C- sertraline 50-100 mg/day-for 3 months"
16247271|NCT01028482|Drug|placebo|placebo
16247272|NCT01028482|Other|psychotherapy|psychotherapy
16247273|NCT01028469|Device|Artelon MTP Spacer|Metatarsophalangeal hemi-implant
16247274|NCT01028456|Other|Light Therapy|10,000 lux / 30 minutes a day
16247275|NCT01028456|Other|100 lux|Placebo light
16247276|NCT01028443|Drug|Sandimmune|
16247277|NCT01028443|Drug|Artelose|
16247278|NCT01028417|Device|Platinum microcoil|Coil Name: Vortx-18, Diamond Shape, Boston Scientific, Cork, Ireland; Coil Description: 80 mm long, fibre coated 0.018 inch diameter platinum microcoil
16247279|NCT01028404|Drug|NN1952|Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
16247280|NCT01028404|Drug|insulin aspart|As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
16247281|NCT01028404|Drug|placebo|Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
16247282|NCT01028404|Drug|NN1952|Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.
16247283|NCT01028404|Drug|insulin aspart|As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
16247284|NCT01028404|Drug|placebo|Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
16247360|NCT01027806|Drug|Montelukast|1 pill per day for 4 months
16247446|NCT01027013|Drug|rebamipide 2% ophthalmic suspension|Instill one drop in each eye four times daily for 12 weeks.
16247285|NCT01028391|Drug|Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.|Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.
16247286|NCT01028391|Drug|Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.|Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.
16247287|NCT01028391|Drug|Metformin|Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.
16247288|NCT01028378|Device|T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser|
16247289|NCT01028365|Other|No intervention|Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.
16247290|NCT01028352|Drug|Duloxetine|"Patients will be treated with open-label duloxetine:
~30 mg daily x 7 days, then
~60 mg daily x 3 weeks, then
~If a patient believes she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will continue taking 60 mg daily for weeks 5-8
~If a patient does not believe she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will have the option of increasing the dose to 60 mg twice daily for weeks 5-8.
~After completion of 8 weeks of therapy, patients who wish to discontinue therapy will taper off the drug over 1 week (50% decrease for 4 days, then additional 50% decrease for 3 days). Patients may continue therapy off-study at the discretion of their treating physician."
16247291|NCT01028339|Drug|Hypertonic saline|2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch
16247292|NCT01028339|Drug|Mannitol|Mannitol
16247293|NCT01028326|Biological|PCV10 and DTaP|A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.
16247294|NCT01028326|Biological|PCV10 and DTaP|A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 180 and a 0.5 mL dose of DTaP on day 60.
16247295|NCT01028326|Biological|hepatitis A vaccine, DTaP, PCV10|A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.
16247296|NCT01028313|Drug|LBH589|20 mg PO three times weekly
16247297|NCT01028313|Drug|Methylprednisolone|1 mg/kg/day PO continuously
16247298|NCT01028300|Device|ProDisc™-L Total Disc Replacement (TDR)|The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
16247299|NCT01028287|Drug|ACTH|Patients with nephrotic range proteinuria randomized to this group will receive 16 units ACTHargel sub-cutaneously every day.
16247300|NCT01028287|Drug|ACTH|Patients with nephrotic range proteinuria randomized to this group will receive 32 units ACTHargel sub-cutaneously every day.
16247301|NCT01028274|Dietary Supplement|Placebo|Two capsules, twice daily with meals for 12 weeks.
16247302|NCT01028274|Dietary Supplement|Investigational Product 1|Two capsules, twice daily with meals for 12 weeks.
16247303|NCT01028274|Dietary Supplement|Investigational Product 2|Two capsules, twice daily with meals for 12 weeks.
16247304|NCT01028261|Drug|ZGN-433|Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.
16247305|NCT01028248|Drug|Ranibizumab (Lucentis)|0.5mg and 2.0mg dose of Ranibizumab 0.05ml administered intravitreally
16247306|NCT01028222|Drug|Nilotinib|Nilotinib was provided as 200 mg hard gelatin capsules for oral use.
16247307|NCT01028222|Drug|DTIC|DTIC was supplied locally as sterile powder for i.v. infusion.
16247308|NCT01028209|Drug|[18F] PBR06|Subjects will be injected with 5mCi, not to exceed >10% of 5mCI, of [18F]PBR06, followed by PET imaging.
16247309|NCT01028170|Drug|furosemide and hypertonic saline solution|250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
16247310|NCT01028170|Drug|furosemide|80-160 mg furosemide (Given over 5 min IV twice a day)
16247311|NCT01028157|Behavioral|STARS: Sistas Talking About Real Solutions|The intervention consisted of 2, 4-hour workshops. The first workshop focused on enhancing ethnic/gender pride, self-esteem, realizing values/setting goals, healthy/unhealthy relationships, partner violence, HIV/STD knowledge, heightening awareness of HIV susceptibility, safer-sex options/skills. The second workshop covered realistic choices in sexual decision making, consistent/proper condom use, setting limits/boundaries, communication styles, and condom skills negotiation. Participants received 3-hour booster sessions at 6- and 9-months to reinforce materials from the initial intervention. Bi-monthly phone calls and quarterly mailings were used to reinforce workshop material and facilitate retention.
16247312|NCT01028157|Behavioral|General Health & Nutrition|Participants in this condition received a 2 hour group session which consisted of general health information and women's health brochures facilitated by a trained health educator. The control group received bi-monthly phone calls and quarterly mailings for retention purposes only, with no intervention material provided.
16247313|NCT01028144|Behavioral|Physical Activity Program|A 17-week motivational and behavioral skills after-school intervention for increasing moderate to vigorous physical activity in low income and minority adolescents.
16247314|NCT01028144|Behavioral|General Health Program|A 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention.
16247315|NCT01028131|Behavioral|Computer-delivered brief intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
16247316|NCT01028131|Behavioral|Contingency Management|Participants randomized by the computer into this condition will view a 20-minute music and tv videos after completing the brief assessment. The research assistant will then briefly describe the CM process, with a period for questions to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
16247319|NCT01028092|Drug|Anti R-IL2 + Cyclosporine|"anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
~Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
~cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2
~corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
16247320|NCT01028092|Drug|Thymoglobulin + Everolimus|"Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days
~Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
~everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml
~corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
16247321|NCT01028092|Drug|Anti R-IL2 + Cyclosporine then Everolimus|"anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
~Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0
~cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml
~corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
16247322|NCT01028079|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.
16247323|NCT01028079|Drug|Ibuprofen|Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.
16247324|NCT01028079|Drug|Placebo|Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.
16247325|NCT01028066|Other|Traditional|The control group will have access to the nutritionist to clear any doubts about the diet prescribed when went out the hospital and will be invited to attend a meeting nutrition in dialogic character at the end of 1 year to ensure fairness in action.
16247326|NCT01028066|Behavioral|Behavioral|The intervention group will go through 4 meetings of food education, to be held within the institution, with approximately 1 hour long, composed of 3 to 8 patients, who may or may not be accompanied by a relative. The first three meetings will be monthly and the fourth will be 6 months after the last one. Each meeting will be developed within the context of dialogic and participatory education, directed to the adoption of a healthy diet and prevention and control of cardiovascular risk factors. The meetings will follow the order: Investigation, Contextualization, Awareness and Strengthening the nutritional concepts, according to the didactics of educator Paulo Freire.
16247327|NCT01028053|Drug|Flutemetamol (18F) Injection|All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
16247328|NCT01028040|Drug|AZD3043|Intravenous, single dose
16247329|NCT01028040|Drug|AZD3043|Infusion, single dose
16247330|NCT01028027|Drug|Loteprednol and tobramycin|Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
16247331|NCT01028027|Drug|Tobramycin and dexamethasone|Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
16247332|NCT01028014|Drug|Pseudoephedrine|Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks
16247333|NCT01028014|Drug|Tamsulosin|Tamsulosin 0.4mg by mouth daily for 2 weeks
16247334|NCT01028014|Drug|Imipramine|Imipramine 25mg daily by mouth for 2 weeks
16247335|NCT01028014|Drug|Cyclobenzaprine|Cyclobenzaprine 10mg daily by mouth for 2 weeks
16247336|NCT01028014|Drug|Lactose capsule|Lactose capsule 1 by mouth daily for 2 weeks
16247337|NCT01028014|Drug|Solifenacin|Solifenacin 5mg by mouth daily for 2 weeks
16247338|NCT01027975|Procedure|laparoscopic Nissen/laparoscopic Thal|
16247339|NCT01027962|Other|ICBT Program|Intensive Computerized Brain Training.
16247340|NCT01027949|Drug|Oral Treprostinil|Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
16247341|NCT01027923|Drug|Plerixafor|
16247342|NCT01027923|Drug|Mitoxantrone|
16247343|NCT01027923|Drug|Etoposide|
16247344|NCT01027923|Drug|Cytarabine|
16247345|NCT01027910|Drug|PCI-24781|Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle
16247346|NCT01027910|Drug|Doxorubicin|Administered intravenously on Day 4 of each 3 week cycle
16247347|NCT01027910|Drug|GCSF|Administered on Day 5 of each 3 weeks cycle in Arm 1 if determined to be clinically indicated, and in all patients enrolled into Arm 2
16247348|NCT01027897|Drug|Doripenem|Doripenem 1 gm administered over 4 hours X 3 doses
16247349|NCT01027884|Drug|Placebo|Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
16247350|NCT01027884|Drug|Idebenone|Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
16247351|NCT01027871|Drug|LY2605541|subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
16247352|NCT01027871|Drug|insulin glargine|subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
16247353|NCT01027858|Behavioral|Aerobic-based exercise training|Six months of thrice-weekly walking program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).
16247354|NCT01027858|Behavioral|CON (control; usual care)|Nutrition education and usual care as prescribed by neurologist
16247355|NCT01027845|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, 4 doses
16247356|NCT01027845|Biological|DTPa|Subcutaneous injection, 4 doses
16247357|NCT01027832|Drug|Piperacillin/Tazobactam for 7 days|Piperacillin/Tazobactam for 7 days
16247358|NCT01027819|Device|Mobile bearing|Mobile bearing in total knee arthroplasty
16247359|NCT01027819|Device|Fixed bearing|Fixed bearing in total knee arthroplasty
16247361|NCT01027793|Drug|Tretinoin cream 0.005%|Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.
16247362|NCT01027793|Device|Superficial Dermabrasion|Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
16247363|NCT01027780|Behavioral|Mindfulness-Based Stress Reduction|The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing.
16247364|NCT01027767|Device|Molecular Breast Imaging|Molecular Breast Imaging
16247365|NCT01027754|Drug|Varenicline|Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
16247366|NCT01027754|Drug|Placebo|Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
16247367|NCT01027741|Behavioral|Phone Referral|Participants receive phone referral to cancer control and prevention services.
16247368|NCT01027741|Behavioral|Tailored Cancer Communication|Mailed material with messages tailored to participant's age, gender, race/ethnicity, whether he or she has kids in the home, reason for calling 211, and cancer control need.
16247369|NCT01027741|Behavioral|Cancer Control Navigator|A cancer control navigator is assigned to each participant. This navigator helps the participant make and keep cancer control and prevention appointments, as well as providing resources and guidance to help address participant barriers to use of needed cancer control and prevention services. Intervention is phone-based.
16247370|NCT01027728|Drug|CCX 354-C|"Cohort 1: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days;
~Cohort 2: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) twice daily for 14 days; and
~Cohort 3: Eight subjects will be randomized to receive 200 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days."
16247371|NCT01027715|Other|EEG monitoring and treatment of EEG seizures|Seizures will prompt treatment with loading doses of phenobarbital (20mg/kg), fosphenytoin (20mg/kg),and midazolam (0.05mg/kg bolus and .15mg/kg/hr infusion tapered over 48 hours)in that order for persisting seizures.
16247372|NCT01027702|Biological|Infusion of donor lymphocytes|A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
16247373|NCT01027689|Drug|alprazolam commercial immediate release oral tablet|1 mg tablet, single dose
16247374|NCT01027689|Drug|alprazolam test sublingual tablet|1 mg tablet, single dose
16247375|NCT01027676|Drug|Study treatment|Gefitinib 250mg/QD plus vorinostat D1~7 & D15-21 / QD q 4weeks
16247376|NCT01027663|Dietary Supplement|Iron Supplement|Iron supplementation (325 mg of ferrous sulfate) once daily for the 2 month duration of the study.
16247377|NCT01027650|Drug|AGN208397 intravitreal injection|AGN208397 intravitreal injection on Day 1.
16247378|NCT01027650|Drug|dexamethasone intravitreal implant|Dexamethasone 700 ug intravitreal implant on Day 1.
16247379|NCT01027637|Other|5 mm vessel clips|evenly placed vessel clips placed at surgery and tracked by ultrasound
16247380|NCT01027611|Drug|proparacaine HCL 0.5%|
16247381|NCT01027611|Drug|proparacaine HCL 0.5% + 4% lidocaine solution|
16247382|NCT01027611|Drug|3.5% viscous lidocaine gel|
16247383|NCT01027598|Drug|Pazopanib|Pazopanib: 600 mg orally daily
16247384|NCT01027598|Drug|Erlotinib|Erlotinib: 150 mg orally daily
16247385|NCT01027572|Device|Implantable neurostimulation system (Medtronic)|Thalamic stimulation will be performed using an implantable neurostimulation system
16247386|NCT01027559|Drug|Sertraline|Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.
16247387|NCT01027559|Behavioral|Cognitive Behavioral Therapy|Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
16247388|NCT01027546|Drug|Tranexamic Acid|Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision
16247389|NCT01027533|Other|Implantation of a multifocal Intraocular lens|Bilateral implantation of a multifocal IOl
16247390|NCT01027520|Other|application of coban dressing|application of a intraoperative coban dressing with reapplications following dressing removal.
16247391|NCT01027494|Drug|Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension|Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days
16247392|NCT01027481|Drug|Lucentis|intravitreally administration of 0.05 ml Lucentis
16247393|NCT01027468|Drug|Bevacizumab|intraocular bevacizumab injection
16247394|NCT01027455|Device|Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device|Humidified warm carbon dioxide gas insufflation during laparosopic procedure
16247395|NCT01027455|Procedure|Laparoscopic Appendicectomy|Dry and Cold carbon dioxide gas insufflation
16247396|NCT01027455|Procedure|Laparoscopic Appendicectomy|Humidified warm carbon dioxide gas insufflation during laparosopic procedure
16247397|NCT01027442|Device|Mucosa-supported single-type guides|Compute generated Mucosa-supported single-type guides
16247398|NCT01027442|Device|Bone-supported guides|Computer generated, Multiple type Bone-supported guides
16247541|NCT01026415|Drug|midazolam|1 mg IV
16247400|NCT01027429|Drug|procaine penicillin and gentamicin|procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days
16247401|NCT01027429|Drug|amoxicillin and gentamicin|oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days
16247402|NCT01027429|Drug|procaine penicillin, gentamicin, amoxicillin|procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
16247403|NCT01027416|Drug|Tamoxifen|Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
16247404|NCT01027390|Behavioral|physical training exercise|physical exercise training at the work site during work time
16247405|NCT01027377|Drug|rFVIIIFc|Single dose
16247406|NCT01027377|Drug|rFVIIIFc|Single dose
16247407|NCT01027364|Drug|Factor IX (rFIXFc)|
16247408|NCT01027364|Drug|rFIX|
16247409|NCT01027351|Biological|Meningococcal (group B) multicomponent recombinant adsorbed vaccine.|Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.
16247410|NCT01027351|Biological|Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)|Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).
16247411|NCT01027338|Other|Tai chi exercise|
16247412|NCT01027325|Other|Dietary Intervention|Starch digestibility and carbohydrate quantity
16247413|NCT01027299|Device|Biventricular pacing|Optimised temporary biventricular pacing.
16247414|NCT01027286|Device|Vitagel|Vitagel applied just prior to closure during primary total knee arthroplasty
16247415|NCT01027273|Behavioral|Prevent Return of Stroke|Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial.
16247416|NCT01027273|Behavioral|Prevent Return of Stroke|The intervention arm will participate in the intervention shortly after enrolling in the trial. The usual care arm will be offered the intervention after 12 months from enrolling in the trial.
16247417|NCT01027260|Drug|Itopride HCI 50 mg|Variable dosing
16247418|NCT01027260|Drug|Itopride HCI 100 mg|Variable dosing
16247419|NCT01027260|Drug|Placebo|Variable dosing
16247420|NCT01027247|Device|Ologen TM|
16247421|NCT01027234|Drug|AZD8418|Single oral dose
16247422|NCT01027234|Drug|Placebo|single oral dose
16247423|NCT01027221|Radiation|neoadjuvant photon radiation|single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
16247424|NCT01027221|Radiation|neoadjuvant photon radiation|single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
16247425|NCT01027221|Radiation|neoadjuvant photon radiation|single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
16247426|NCT01027208|Drug|Ixabepilone|Lyophilized and solvent, IV, 10-50 mg/m²
16247427|NCT01027195|Device|Bipolar Radiofrequency (Aquamantys 6.0)|
16247428|NCT01027195|Device|Standard Bovie Electrocautery|
16247429|NCT01027182|Drug|Raltegravir|One 400mg tablet on day 1.
16247430|NCT01027169|Drug|safinamide|single dose of 50mg safinamide on Day 1
16247431|NCT01027169|Drug|safinamide|single dose of 50mg safinamide on Day 1
16247432|NCT01027169|Drug|safinamide|single dose of 50mg safinamide on Day 1
16247433|NCT01027156|Behavioral|High Intensity Exercise|In this study, participants will be instructed to sprint maximally for a period of 30 seconds. Following 30s rest, the participants will be instructed to repeat this procedure a further 3 times. This equates to 2 minutes of maximal effort sprinting interspersed with 2 minutes recovery. Participants will be requested to perform this protocol 3 times weekly. Training progression will be implemented by increasing the number of repeats from four repetitions during weeks 1 and 2, to five repetitions during weeks 3 and 4, to six repetitions during weeks 5 and 6. Finally, during week 7 participants will still perform six repetitions but interspersed by only 20 s recovery.
16247434|NCT01027143|Dietary Supplement|omega-3 polyunsaturated fatty acids|ProEPA Xtra 1000mg softgels: 3 softgels twice daily
16247435|NCT01027143|Drug|Omega-3 Fatty Acid|Soybean oil: 3(age 12-25) matched softgel caps twice daily
16247436|NCT01027117|Drug|Revatio|Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
16247437|NCT01027117|Drug|Revatio|Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
16247438|NCT01027117|Drug|Revatio|Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
16247439|NCT01027104|Other|Education|Firearm injury prevention anticipatory guidance curriculum
16247440|NCT01027065|Drug|CYT107+GenHevac+entecavir or tenofovir|4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107 and vaccine) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment
16247441|NCT01027065|Drug|CYT107+ entecavir or tenofovir|4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment
16247442|NCT01027052|Other|Hamburger meat patty with salt|hamburger meat cooked with salt
16247443|NCT01027052|Other|Hamburger meat patty with spice blend|hamburger meat cooked with spice mixture
16247444|NCT01027026|Other|Early discharge|The patients are discharged the same day as coronary angiography.
16247445|NCT01027026|Other|Care as usual. No intervention. (Control group)|The patients are admitted and cared as usual in cardiology ward.
16247447|NCT01027013|Drug|placebo eye drops|Instill one drop in each eye four times daily for 12 weeks.
16247448|NCT01027000|Biological|rituximab|
16247449|NCT01027000|Drug|busulfan|
16247450|NCT01027000|Drug|cyclophosphamide|
16247451|NCT01027000|Drug|fludarabine phosphate|
16247452|NCT01027000|Drug|methotrexate|
16247453|NCT01027000|Drug|sirolimus|
16247454|NCT01027000|Drug|tacrolimus|
16247455|NCT01027000|Procedure|allogeneic stem cell transplant|
16247456|NCT01026987|Drug|G-CSF|Unrelated donors will receive only G-CSF (10 ug/Kg S/C qDay x5-6 days) prior to pheresis (collection of the stem cells). Unrelated donors will only be followed per NMDP guidelines.
16247457|NCT01026987|Drug|AMD3100|
16247458|NCT01026987|Procedure|Leukapheresis|
16247459|NCT01026987|Procedure|Stem Cell Infusion|
16247460|NCT01026974|Biological|rMenB|
16247461|NCT01026974|Biological|rMenB+OMV NZ|
16247462|NCT01026961|Drug|Phenylephrine HCL|Phenylephrine HCL 10mg
16247463|NCT01026961|Drug|Phenylephrine HCL/Acetaminophen/Dimethindene Maleate|Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
16247464|NCT01026948|Drug|Dinoprostone|Propess© vaginal delivery system consists of a non-biodegradable polymeric drug delivery device containing 10 mg Dinoprostone (PGE2) dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours) in women with intact membranes whereas release is higher and more variable in women with premature rupture of membranes.
16247465|NCT01026948|Device|Monica AN 24|AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
16247466|NCT01026935|Device|Open inguinal hernia repair|Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks
16247467|NCT01026909|Drug|Aristospan 20mg|Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
16247468|NCT01026883|Other|Blood draw|A venous blood sample will be taken (15 ml). Blood will be collected in 5 tubes. To avoid hematocrit variations due to the blood draw procedure, the first tube will be discarded. After that, the tourniquet which is used for venipuncture will be removed and 4 EDTA tubes (each 3 ml) will be filled with blood for hematocrit determination, one tube will be sent to the Department of Laboratory Medicine, and the other ones will be processed at the Department of Clinical Pharmacology.
16247469|NCT01026870|Drug|SCH 32088 mometasone furoate (MF) metered-dose inhaler|2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
16247470|NCT01026870|Drug|Placebo metered-dose inhaler BID|2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
16247471|NCT01026857|Drug|Propionyl-L-Carnitine|PLC colon release tablet 1 g/die for 4 weeks
16247472|NCT01026857|Drug|Propionyl-L-Carnitine|PLC colon release tablet 2 g/die for 4 weeks
16247473|NCT01026857|Drug|Placebo|Placebo PLC colon release tablet 2 g/die for 4 weeks
16247474|NCT01026844|Drug|erlotinib|Taken orally once a day
16247475|NCT01026844|Drug|hydroxychloroquine|Taken orally once a day
16247476|NCT01026831|Drug|Preservative-Free Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks
16247477|NCT01026831|Drug|Comparator: timolol|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
16247478|NCT01026818|Drug|Tadalafil|Administered by mouth for 9 months
16247479|NCT01026818|Drug|Placebo|Administered by mouth, daily or on demand for 9 months
16247480|NCT01026805|Device|Interlace Medical 1st Generation Hysteroscopic Morcellator|The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.
16247481|NCT01026792|Drug|Temsirolimus|Given IV
16247482|NCT01026792|Other|Laboratory Biomarker Analysis|Correlative studies
16247483|NCT01026753|Behavioral|Refrigerator Magnet|The refrigerator magnet contains a telephone number for a Provincial Health Contact Centre and a URL for a colorectal cancer Website that patients can access to learn more about colorectal cancer, screening and the fecal occult blood test. Patients can also have their questions answered.
16247484|NCT01026740|Drug|Ceftobiprole|single intravenous (i.v.) infusion, 500 mg ceftobiprole administered over 2 hours.
16247485|NCT01026727|Drug|MPC-4326 plus a 2-3 drug optimized background regimen (OBR)|For treatment arm #1: the MPC-4326 dose will be selected based on the inclusion of raltegravir (i.e., will be limited to 300 mg BID) or inclusion of darunavir (i.e., will be assigned 400 mg BID) in the OBR. If both raltegravir and darunavir are included in the OBR for a subject, the subject will be limited to 300 mg BID
16247486|NCT01026727|Drug|3-4 commercially available antiretroviral drugs|For treatment arm #2: the antiretroviral regimen, dosage and frequency will be selected by the investigator.
16247487|NCT01026714|Drug|flurbiprofen|assessment of flurbiprofen plasmatic and capillary rates
16247488|NCT01026714|Drug|flurbiprofen, rifampicin|assessment of flurbiprofen plasmatic and capillary rates
16247489|NCT01026714|Drug|flurbiprofen + fluconazole|assessment of flurbiprofen plasmatic and capillary rates
16247490|NCT01026701|Drug|bortezomib|injection into a vein 1.3 mg/m2 twice a week for 21 days
16247542|NCT01026415|Drug|ketoconazole|400 mg/day PO
16247543|NCT01026415|Drug|brentuximab vedotin|1.2 mg/kg IV every 21 days
16247597|NCT01026064|Drug|Azithromycin|Zithromax (250 mg oral capsule).
16247598|NCT01026064|Drug|Placebo|Matching placebo
16247599|NCT01026051|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, Melanoma
16247491|NCT01026688|Other|Toolkit|Cardiovascular Disease Toolkit mailed by the Canadian Diabetes Association to family physicians, accompanying the Spring/Summer 2009 edition of the quarterly newsletter, Canadian Diabetes. (Mailed in June 2009.) The Toolkit includes a summary of selected sections of the practice guidelines targeted towards primary care physicians; a synopsis of the key messages pertaining to cardiovascular disease risk; a laminated card with a simplified algorithm for cardiovascular risk assessment and treatment; and a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool.
16247492|NCT01026688|Other|Control|The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed to Control arm physicians with the May 2010 issue of the newsletter.
16247493|NCT01026675|Procedure|50 g oral glucose challenge test - 75 g oral glucose tolerance test|50 g oral glucose challenge test at 6-13 weeks of gestation and 75 g oral glucose tolerance test at 24-28 weeks of gestation.
16247494|NCT01026662|Procedure|Ablation and skin resurfacing|Subjects will receive treatment on the abdomen at different timepoints prior to a scheduled abdominoplasty. Following tissues excision samples of the treated tissue will be taken for analysis.
16247495|NCT01026662|Device|eMatrixCO2|
16247496|NCT01026649|Procedure|Central venous catheterization|Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
16247497|NCT01026649|Procedure|Central venous catheterization|Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
16247498|NCT01026636|Drug|Ceftobiprole|
16247499|NCT01026623|Biological|Cixutumumab|Given IV
16247500|NCT01026623|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16247501|NCT01026623|Drug|Temsirolimus|Given IV
16247502|NCT01026610|Drug|LB80380 90 mg|LB80380 90 mg + placebo tablets, once daily, for 48 weeks
16247503|NCT01026610|Drug|LB80380 150 mg|LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
16247504|NCT01026610|Drug|entecavir 0.5 mg|entecavir 0.5 mg tablet, once daily, for 48 weeks
16247505|NCT01026597|Drug|REGN727|5 IV cohorts (dose 1, 2, 3, 4, and 5)
16247506|NCT01026597|Drug|Placebo|5 IV cohorts (dose 1, 2, 3, 4, and 5)
16247507|NCT01026584|Drug|Aripiprazole|6 week prospective study
16247508|NCT01026558|Drug|Ceftobiprole|Ceftobiprole, 500 mg as single iv infusion over 2 hours
16247509|NCT01026545|Drug|PF-04287881|500 mg once daily for 10 days
16247510|NCT01026545|Drug|Placebo|To match 500 mg dose once daily for 10 days
16247511|NCT01026545|Drug|PF-04287881|750 mg once daily for 10 days
16247512|NCT01026545|Drug|Placebo|To match 750 mg dose once daily for 10 days
16247513|NCT01026545|Drug|PF-04287881|1100 mg once daily for 10 days
16247514|NCT01026545|Drug|Placebo|To match 1100 mg dose once daily for 10 days
16247515|NCT01026545|Drug|PF-04287881|Optional cohort with dose not greater than 1100 mg
16247516|NCT01026545|Drug|Placebo|Optional cohort to match dose not greater than 1100 mg
16247517|NCT01026545|Drug|PF-04287881|750 mg dose once daily for 10 days
16247518|NCT01026545|Drug|Placebo|To match 750 mg dose once daily for 10 days
16247519|NCT01026545|Drug|PF-04287881|1100 mg dose once daily for 10 days
16247520|NCT01026545|Drug|Placebo|To match 1100 mg dose once daily for 10 days
16247521|NCT01026532|Biological|Segmental Allergen Challenge|Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed.
16247522|NCT01026519|Drug|REGN88|Single dose of REGN88 and 43 day follow up.
16247523|NCT01026519|Other|Placebo|Placebo to match REGN88 administration
16247524|NCT01026506|Dietary Supplement|conjugated linoleic acid|3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or placebo oil mixed in yoghurt for 12 weeks
16247525|NCT01026493|Drug|temozolomide 60 mg x 21 days|Temozolomide 60 mg/m2 x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.
16247526|NCT01026493|Drug|temozolomide 75 mg x 21 days|Temozolomide 75 mg/m2 x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.
16247527|NCT01026493|Drug|ABT-888 20 mg x 21 days|20 mg bid x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.
16247528|NCT01026493|Drug|ABT-888 40 mg x 21 days|40 mg bid x 21 days/28-day cycle. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude further therapy
16247529|NCT01026493|Drug|Temozolomide 150 mg x 5 days|150 mg/m2 x 5 days (up to 200 mg/m2 after 2nd cycle)*, with a 28-day cycle; dose reduction to 125 mg/m2 if necessary. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude
16247530|NCT01026493|Drug|ABT-888 40 mg x 5 days|40 mg bid x 5 days/28-day cycle. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude
16247531|NCT01026467|Drug|cisplatin|Given IV
16247532|NCT01026467|Drug|carboplatin|Given IV
16247533|NCT01026467|Other|questionnaire administration|
16247534|NCT01026454|Drug|acyclovir|acyclovir 400 mg orally, twice daily for 12 weeks
16247535|NCT01026454|Drug|valacyclovir|valacyclovir 1.5 g orally, twice daily, for 12 weeks
16247536|NCT01026441|Device|Vela100 (Aesthetic)|6 treatments once a week
16247537|NCT01026428|Drug|Safinamide + Levodopa|Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
16247538|NCT01026428|Other|Placebo + Levodopa|Treatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
16247539|NCT01026415|Drug|brentuximab vedotin|1.8 mg/kg IV every 21 days
16247540|NCT01026415|Drug|rifampin|600 mg/day PO
16247544|NCT01026402|Drug|AZD2014|Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.
16247545|NCT01026389|Drug|Dotarem|DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus
16247546|NCT01026389|Drug|Gadovist|Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus
16247547|NCT01026376|Drug|decitabine|Cycles of 15mg/m2 infusion during 3h, 3 times a day, per 3 days
16247548|NCT01026376|Drug|decitabine|Cycles of 20mg/m2 infusion during 1h, once a day, per 5 days
16247549|NCT01026363|Drug|Ergocalciferol|Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
16247550|NCT01026363|Drug|Calcitriol|0.25 mcg tablet once daily for 14 days
16247551|NCT01026350|Dietary Supplement|colostrum enriched with anti flu antibodies|each volunteer will receive six 1.2 g oral tablets (equivalent to 600 mg of bovine colostrum powder each) once a day for two weeks.
16247552|NCT01026337|Genetic|mutation analysis|Correlative study
16247553|NCT01026337|Other|pharmacological study|Correlative study
16247554|NCT01026337|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16247555|NCT01026337|Drug|sunitinib malate|Given orally
16247556|NCT01026337|Other|immunohistochemistry staining method|Correlative study
16247557|NCT01026337|Other|laboratory biomarker analysis|Correlative study
16247558|NCT01026324|Drug|dinaciclib|Given IV
16247559|NCT01026324|Other|pharmacological study|Correlative studies
16247560|NCT01026324|Other|laboratory biomarker analysis|Correlative studies
16247561|NCT01026311|Drug|Coenzyme q 10|200 mg of Coenzyme q 10
16247562|NCT01026311|Drug|placebo|1 placebo q d during treatment period
16247563|NCT01026298|Other|FDA-Approved Treatment|8 weeks of treatment with Continuous Positive Airway Pressure (CPAP)
16247564|NCT01026285|Drug|Risperidone Long-Acting injectable or oral antipsychotics|According to label
16247565|NCT01026259|Other|Warming of surgical incision|A warming pack (chemical activation) is applied to the dressing over the surgical incision, warming to 38 degrees C, for a period of 90 minutes times 6 treatments. The first treatment occurs in the PACU.
16247566|NCT01026259|Other|Warming dressing without actual warming|The same type of surgical incision dressing is used but no warming treatments are administered.
16247567|NCT01026246|Drug|Placebo|The placebo used will be normal saline (0.9 percent NaCl).
16247568|NCT01026246|Biological|EBA-175 RII-NG Malaria Vaccine|EBA-175 RII-NG malaria vaccine is supplied as a white, translucent, cloudy, nonparticulate liquid suspension in single-dose clear glass vials pre-mixed with Adju-Phos aluminum phosphate adjuvant. Each 2-mL vial of EBA-175 RII-NG vaccine contains: 0.7 mL (0.5 mL per dose) EBA-175 RII-NG, at the required dose concentration, 5 percent sucrose, 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant, sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride), and no preservative.
16247569|NCT01026233|Drug|brentuximab vedotin|1.8 mg/kg IV every 21 days
16247570|NCT01026220|Biological|bleomycin sulfate|Given IV or SC
16247571|NCT01026220|Drug|doxorubicin hydrochloride|Given IV
16247572|NCT01026220|Drug|liposomal vincristine sulfate|Given IV
16247573|NCT01026220|Drug|vinorelbine tartrate|Given IV
16247574|NCT01026220|Drug|cyclophosphamide|Given IV
16247575|NCT01026220|Drug|etoposide phosphate|Given IV
16247576|NCT01026220|Drug|prednisone|Given IV
16247577|NCT01026220|Biological|filgrastim|Given IV or SC
16247578|NCT01026220|Drug|ifosfamide|Given IV
16247579|NCT01026207|Device|Polysomnography|Sleep study polysomnography compared with portable monitoring
16247580|NCT01026194|Drug|Placebo / Teneli (Teneligliptin) + pio (pioglitazone)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
16247581|NCT01026194|Drug|Teneli / Teneli + pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
16247582|NCT01026155|Other|Respiratory muscle training|Respiratory muscle endurance training by means of isocapnic voluntary hyperpnoea
16247583|NCT01026142|Drug|Capecitabine|1000 mg/m2 po twice daily for 14 days every 3 weeks
16247584|NCT01026142|Drug|Capecitabine|1250 mg/m2 po twice daily for 14 days every 3 weeks
16247585|NCT01026142|Drug|Pertuzumab|840 mg iv loading, then 420 mg iv every 3 weeks
16247586|NCT01026142|Drug|Trastuzumab|8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
16247587|NCT01026129|Drug|Remifentanil|Bolus dose of intravenous remifentanil 0,25 mcg/kg given once before emergence of general anesthesia.
16247588|NCT01026129|Drug|Remifentanil|Bolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia.
16247589|NCT01026129|Drug|lidocaine|Bolus dose of intravenous remifentanil 0.5 mck/kg given once before emergence of general anesthesia.
16247590|NCT01026116|Drug|Epirubicin|75 mg/m2 every-3-week for four cycles
16247591|NCT01026116|Drug|Cyclophosphamide|600 mg/m2 every-3-week for four cycles
16247592|NCT01026116|Drug|Paclitaxel|175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
16247593|NCT01026103|Device|Tri Staple Technology stapler|This is a single arm study.
16247594|NCT01026090|Drug|Dronedarone|"Film-coated tablet
~Oral administration under fed conditions (during breakfast and dinner)"
16247595|NCT01026090|Drug|Placebo (for dronedarone)|"film-coated tablet strictly identical in appearance
~Oral administration under fed conditions (during breakfast and dinner)"
16247596|NCT01026064|Other|Cantharidin|Cantharone topical liquid containing 0.7% cantharidin (blistering agent) is applied as 25 µL of 0.1% cantharone solution in acetone
16247600|NCT01026038|Biological|13-valent pneumococcal conjugate vaccine|All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).
16247601|NCT01026025|Device|Duet TRS|This is a single arm study.
16247602|NCT01026012|Drug|regadenoson|Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.
16247603|NCT01025999|Other|No intervention|
16247604|NCT01025960|Procedure|Standard Inspection Colonoscopy|The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
16247605|NCT01025960|Procedure|Dual Inspection Colonoscopy|The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
16247606|NCT01025934|Drug|Bevacizumab|
16247607|NCT01025934|Other|sham|
16247608|NCT01025921|Drug|colistin (Tadim)|500.000 units of inhaled colistin three times daily for 10 days
16247609|NCT01025921|Other|inhaled normal saline|inhalation of 2,5cc Normal Saline via nebulisation
16247610|NCT01025908|Behavioral|Psychotherapy|Cognitive Behavioral Therapy
16247611|NCT01025908|Behavioral|Supportative psychotherapy|Supportative psychotherapy
16247612|NCT01025895|Procedure|acl reconstruction - double bundle technique|
16247613|NCT01025895|Procedure|acle reconstruction - single bundle technique|
16247614|NCT01025882|Drug|gemcitabine hydrochloride|Given IV
16247615|NCT01025882|Radiation|stereotactic body radiation therapy|Given as a single fraction
16247616|NCT01025869|Device|Cinatra™ Corolimus Eluting Coronary Stent System|Stent implantation
16247617|NCT01025856|Other|Rich in MUFA diet -PA|The patients will follow a rich in MUFA diet without a physical activity program.
16247618|NCT01025856|Other|high fiber/low glycemic index diet + pa|patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.
16247619|NCT01025856|Other|Rich in MUFA diet+PA|Patients will follow for two months a rich in MUFA diet with a physical activity program.
16247620|NCT01025856|Other|High fibre/low glycemic index diet-PA|Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
16247621|NCT01025843|Drug|MK-5478|In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.
16247622|NCT01025843|Drug|Comparator: Candesartan cilexetil|Single dose administration of candesartan, 32 mg oral tablet
16247623|NCT01025843|Drug|Comparator: Pbo|Placebo
16247624|NCT01025830|Drug|Triomune|Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day
16247625|NCT01025830|Drug|Zerit/Epivir/Viramune|Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.
16247626|NCT01025817|Drug|Everolimus and tacrolimus|"Everolimus:
~Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
~Dose: 1.5 mg per day
~Frequency: 0.75 mg twice daily
~Tacrolimus:
~Dose adjusted to maintain specific blood levels"
16247627|NCT01025817|Drug|mycophenolate mofetil and tacrolimus|Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels
16247628|NCT01025791|Drug|MK-8266 0.1 mg|Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant. Some participants will receive study drug with food.
16247629|NCT01025791|Drug|MK-8266 1.0 mg|MK-8266 1.0 mg oral capsule. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.
16247630|NCT01025791|Drug|Placebo|Placebo to match MK-8266 0.1 or 1.0 mg. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.
16247631|NCT01025778|Drug|Clofarabine for remission induction|
16247632|NCT01025778|Drug|Etoposide for remission induction|
16247633|NCT01025778|Drug|Cyclophosphamide for remission induction|
16247634|NCT01025778|Drug|Clofarabine in conditioning before transplantation|
16247635|NCT01025778|Drug|Thiotepa in conditioning before transplantation|
16247636|NCT01025778|Drug|Melfalan in conditioning before transplantation|
16247637|NCT01025778|Procedure|Haploidentical transplantation of T-cell depleted graft|
16247638|NCT01025778|Procedure|Donor lymphocyte infusion|
16247639|NCT01025765|Drug|Pioglitazone|Pioglitazone(30mg qd) for 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; < 75 kg, 1000mg).
16247640|NCT01025765|Drug|Acarbose|Acarbose (50 mg/per meal) for 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; < 75 kg, 1000mg).
16247641|NCT01025765|Drug|Metformin|Metformin (500 mg tid) 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; < 75 kg, 1000mg). From week 13, all the subjects will receive pegylated interferon alfa plus ribavirin for 40 weeks.
16247642|NCT01025752|Behavioral|Face to face cognitive behavior therapy|Ten session face to face cognitive behavior therapy for chronic low back pain
16247643|NCT01025752|Behavioral|IVR based cognitive behavioral therapy|Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy
16247644|NCT01025739|Device|EsophyX™ system with SerosaFuse fasteners|The EsophyX™ system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct the gastroesophageal junction through anterior partial fundoplication with tailored delivery of multiple fasteners during a single-device insertion.
16247645|NCT01025726|Behavioral|Police Patrolled Walking plus Social Marketing|Identify walking route, hire walking leaders and police support, maintain route and monitor stray dogs PLUS grass-roots social marketing campaign to promote walking on the route
16247646|NCT01025726|Behavioral|Police Patrolled Walking Program Only|Identify walking route, hire walking leaders and police support, maintain route and monitor stray dogs
16247647|NCT01025726|Behavioral|General Health Education|Host community events for chronic disease education
16247648|NCT01025713|Drug|GS-9411|Inhaled GS-9411
16247649|NCT01025713|Drug|Placebo|Inhaled Placebo
16247650|NCT01025700|Drug|Cesemat|1 mg capsule per day for 21 days
16247651|NCT01025687|Dietary Supplement|water with noncalorie sweetener|
16247652|NCT01025687|Dietary Supplement|water with glucose|
16247653|NCT01025687|Behavioral|TV program showed while feeding|
16247654|NCT01025687|Behavioral|TV program showed while feeding|
16247655|NCT01025674|Behavioral|Positive Action program|Components of the Positive Action program (6 units) use research-supported educational strategies/methods that include active learning, positive classroom management, teacher training, detailed curriculum with almost daily lessons, school-wide climate-change program, and family program of parent support/involvement.
16247656|NCT01025661|Other|Chiropractic care|Clinical examinations and treatments were performed at the outpatient clinic. The patients were assessed and treated by research assistants and the clinical care was supervised by state registered chiropractors. The choice of therapy and modality was pragmatic and based on the analysis of different functions such as mobility, tenderness, muscle tension and tone, and each patient's relative symptoms. Chiropractic care included high-velocity and low-amplitude techniques, soft-tissue or myofascial techniques, and arthrokinematic stabilizing exercises or a combination of these. Patients were treated in 1-2 sessions per week during the trial.
16247657|NCT01025648|Drug|E004 (epinephrine inhalation aerosol), 90 mcg/actuation|E004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period
16247658|NCT01025648|Drug|E004 Placebo|E004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period
16247659|NCT01025648|Drug|E004 (epinephrine inhalation aerosol), 125 mcg|E004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period
16247660|NCT01025648|Drug|E004 (epinephrine inhalation aerosol), 220 mcg|E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period
16247661|NCT01025648|Drug|epinephrine inhalation aerosol, CFC propelled|epinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period
16247662|NCT01025648|Drug|E004 (epinephrine inhalation aerosol), 160 mcg|E004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period
16247663|NCT01025635|Drug|Azelaic acid foam 15%|Applied topically twice daily for 12 weeks
16247664|NCT01025635|Drug|Vehicle foam|Applied topically twice daily for 12 weeks
16247665|NCT01025622|Biological|autologous highly purified CD133+ stem cells (SCs)|Intrahepatic reinfusion in cirrhotic patients
16247666|NCT01025596|Drug|Interleukin-7|4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week
16247667|NCT01025583|Dietary Supplement|hypotonic oral rehydration solution|30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.
16247668|NCT01025583|Dietary Supplement|Hypotonic oral rehydration solution with Zn and prebiotics|30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.
16247669|NCT01025570|Drug|Gemcitabine, Bosutinib|Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily
16247670|NCT01025557|Other|Dietary intervention|Dietary treatments with beverages
16247671|NCT01025544|Biological|Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)|Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
16247672|NCT01025544|Biological|Hiberix (Haemophilus influenzae type b (Hib) vaccine)|Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
16247673|NCT01025518|Other|Resistance training|12 weeks of resistance training in combination with protein and creatine or placebo ingestion
16247674|NCT01025518|Dietary Supplement|Protein and creatine|30 g of protein with each training session, 5 g of creatine pr day
16247675|NCT01025518|Dietary Supplement|Placebo|Maltodextrine
16247676|NCT01025505|Drug|Nilotinib|The dose of NIL is 800 mg daily (400 mg twice daily). It must be adapted according to specific guidelines in case of adverse events (AE). It cannot be increased.
16247677|NCT01025505|Drug|Imatinib|The dose of IM is 600 mg daily (300 mg b.i.d.). It must be adapted according to specific guidelines in case of AE. It cannot be increased.
16247678|NCT01025492|Drug|Trilipix|135 mg po daily
16247679|NCT01025492|Drug|placebo|one tablet po daily
16247680|NCT01025466|Drug|Rivastigmine transdermal patch (Exelon patch), memantine|All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.
16247681|NCT01025466|Drug|Rivastigmine transdermal patch|All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.
16247682|NCT01025453|Drug|Temsirolimus and Sorafenib|Treatment will be with sorafenib 200 mg orally twice a day and temsirolimus 25 mg intravenous weekly. A cycle will be equivalent to 4 weeks of treatment.
16247683|NCT01025440|Device|Continuous Positive Airway Pressure|"Continuous Positive Airway Pressure (CPAP) Dose: A flow (35 L/min) or pressure (btw 4 and 20 cmH20 -individual to each subject) is set on the device.
~Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)
~Duration:"
16247684|NCT01025427|Drug|Raltegravir, tenofovir/emtricitabine|16 controllers will be treated with open-label raltegravir/tenofovir/emtricitabine for 24 weeks.
16247685|NCT01025414|Drug|enteral nutrition|Group A - enteral feeding was started 2 to 4 hours after catheter placement via enteral tube inserted via endoscope below the Treitz's ligament into first intestinal loop (location of the tip) (Nutricial Ltd. Flocare). The initial flow rate was 10 ml/ hour, final 125 ml/ hour. Energy requirements was calculated using following rule: 0.15-0.2 gN/ kg and 130-170 kcal/ gN. Diet: Peptisorb (Nutricia Ltd.) - oligopeptide diet well tolerated by intestines
16247844|NCT01024075|Drug|Saline|8cc of Saline mixed with Sinufoam
16247887|NCT01023646|Other|Fiber|Unrefined Carbohydrate
16247686|NCT01025414|Drug|Parenteral nutrition|Parenteral nutrition was started 2 to 4 hours after venous catheter placement (standard Arrow type, the tip located 5 cm over right vestibule, the location confirmed on chest X-ray) and continued until oral diet covering at least 60% of daily caloric and protein demand. The energy requirements were calculated using following rule: 0.15-0.2 gN/ kg and 130-170 kcal/ gN. Parenteral diets: Aminoplasmal 10%, Lipofundin LCT/MCT 10 and 20%, 40% Glucose, Tracutil (microelements and trace elements), Cernevit (vitamins), electrolytes
16247687|NCT01025401|Device|3-D accelerometric and magnetic sensors|sensors are positioned on the right wrist, the left wrist and on the head.
16247688|NCT01025375|Dietary Supplement|inulin|10gram/day inulin for 13-day treatment
16247689|NCT01025375|Dietary Supplement|inulin|16gram/day inulin for 13-day treatment
16247690|NCT01025375|Dietary Supplement|placebo|16gram/day maltodextrin (placebo) for 13-day treatment
16247691|NCT01025362|Behavioral|Lactation counseling|The Baby-Friendly Community Health Service intervention to improve quality of lactation counseling.
16247692|NCT01025362|Behavioral|Standard care|Child Health Services offered standard care
16247693|NCT01025349|Drug|Bevacizumab, docetaxel, cisplatin|"Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks.
~docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks.
~cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks."
16247694|NCT01025336|Other|Blood draw|Group 1.1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1 Group 1.2- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1
16247695|NCT01025336|Other|Blood draw|Group 1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPNC was administered in the deltoid muscle at year 1
16247696|NCT01025323|Behavioral|Lifestyle modification|DASH diet and exercise advice
16247697|NCT01025323|Behavioral|Lifestyle modification|DASH diet, exercise with systematic instruction by a dietician and/or coordinator
16247698|NCT01025297|Drug|Interleukin-7|3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
16247699|NCT01025284|Drug|LY2523355|Administered intravenously as a 1-hour infusion
16247700|NCT01025284|Drug|Granulocyte colony-stimulating factor (G-CSF)|Administered subcutaneously
16247701|NCT01025271|Drug|Daptomycin|one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight
16247702|NCT01025258|Behavioral|Frequent Scheduled CF clinic visits|Mandatory scheduled visit at the CF clinic every 1-2 months or sooner, if needed, for an evaluation by a a specialized CF team member such as: a pulmonary physician, a gastroenterologist, a dietitian, a clinical pharmacist
16247703|NCT01025258|Behavioral|frequent telephone calls to patients pre and post visits to the clinic|Frequent telephone calls for monitoring, educating and identifying barriers in adherence will be made by a designated CF team member such as the CF nurse or the CF clinical pharmacist.
16247704|NCT01025245|Drug|remifentanil, MgSO4|Patients undergoing thyroidectomy will be randomly assigned to one of three groups. Remifentanil will be infused intraoperatively at 0.05 ㎍/㎏/min (group Ⅰ) or 0.2 ㎍/㎏/min (group Ⅱ & Ⅲ). Patients in group Ⅲ will be received 30 ㎎/㎏ MgSO4 at the induction of general anesthesia followed by a maintenance infusion of 10 ㎎/㎏/hr intraoperatively until skin closure.
16247705|NCT01025232|Drug|Ranibizumab|Intravitreal Injection of 2.0mg formulation
16247706|NCT01025219|Genetic|Collect 10 ml of Saliva for DNA extraction|After signed written informed consent, all patients and controls have clinical and neuropsychological evaluations (DIGS, WURS, BROWN, BIS, SSS and IGT) for phenotypic diagnosis and collection of saliva for DNA extraction and genotyping diagnosis.
16247707|NCT01025206|Biological|BI-505|Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,
16247708|NCT01025193|Drug|Belimumab|Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting.
16247709|NCT01025180|Other|Procalcitonin level|"The duration of antibiotic treatment is based on PCT level:
~< 0.25 ng/ml: antibiotic should be stopped
~0.25 < PCT <0.5: antibiotic prescription is not recommended
~> 0.5 ng/ml: antibiotic should be used"
16247710|NCT01025167|Dietary Supplement|Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)|500 ml per day / treatment period 11-14 weeks
16247711|NCT01025167|Dietary Supplement|Fresubin(R)|500 ml/a nutritionally complete enteral standard feed (isoenergetic)
16247712|NCT01025154|Drug|Clofarabine|Induction Cycle: 20 mg/m^2 IV over approximately 1 hour daily for 5 days (days 1-5)
16247713|NCT01025154|Drug|Idarubicin|Induction Cycle: 10 mg/m^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours
16247714|NCT01025154|Drug|Cytarabine|Induction Cycle: 1 g/m^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.
16247715|NCT01025141|Device|Skeletal anchorage (MINISCREW)|Skeletal anchorage
16247716|NCT01025141|Device|dental anchorage|dental anchorage (reference)
16247717|NCT01025128|Drug|25 OH vitamin D|oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
16247718|NCT01025115|Dietary Supplement|Diamel|Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
16247845|NCT01024062|Drug|Paclitaxel|Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
16247888|NCT01023646|Other|Carbohydrate load|Carbohydrate
16247719|NCT01025115|Dietary Supplement|Placebo|Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
16247720|NCT01025102|Drug|Naropin 0.1% cum sufentanil|20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
16247721|NCT01025089|Drug|Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide|Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients who have completed the neo-adjuvant treatment regimen, who have no evidence of distant progression, and who are medically operable will proceed to surgical resection within 6 weeks of the last infusion.
16247722|NCT01025076|Device|StomaphyX|StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
16247723|NCT01025050|Procedure|Intrastromal Correction of Presbyopia|On all patients an intrastromal pattern consisting of concentric rings will be applied.
16247724|NCT01025037|Device|Conexa Reconstructive Tissue Matrix|Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
16247725|NCT01025024|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16247726|NCT01025011|Device|Fundus photography, cubital blood draw|blood draw from a cubital vein to measure hemoglobin concentration taking a fundus photography with a Nidek AFC-230, no pupil dilation needed
16247727|NCT01024998|Biological|AAV2-sFLT01|2 x 10^8 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.
16247728|NCT01024998|Biological|AAV2-sFLT01|2 x 10^9 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.
16247729|NCT01024998|Biological|AAV2-sFLT01|6 x 10^9 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.
16247730|NCT01024998|Biological|AAV2-sFLT01|2 x 10^10 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.
16247731|NCT01024972|Drug|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
16247732|NCT01024972|Drug|Placebo|equiosmolar volume (5% mannitol) every 6 hours x 7 days
16247733|NCT01024959|Other|PCA3 Assay|Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy
16247734|NCT01024946|Drug|everolimus|Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity of toxicity encountered. One cycle will be considered 28 days. Patients will have CT scans to evaluate for response after cycle 1 and cycle 2, and then every two cycles thereafter.
16247735|NCT01024933|Behavioral|Positive Affect/Self-Affirmation/Motivational Interviewing|The PASA group-intervention will receive small gifts one week prior to their scheduled follow up. The PASA intervention involves reminding participants to think about their proud and positive moments. The motivational interviewing intervention includes assessing the patient's motivation and confidence; elicit barriers and concerns; summarize in a non-threatening manner the 'pros' and 'cons' of patient's concerns, thereby eliciting positive self-motivational statements about the behavior. Follow up will be every two months.
16247736|NCT01024933|Behavioral|Educational and Behavioral|The Education and Behavioral Contract (Control group)will receive an educational workbook and behavioral contract. In addition, each patient will receive a home blood pressure device for self-monitoring, and will be called every two months.
16247737|NCT01024920|Drug|BIBF 1120|VEGF inhibitor
16247738|NCT01024920|Drug|sunitinib|VEGF inhibitor
16247739|NCT01024907|Radiation|proton beam radiation therapy|Undergo radiation
16247740|NCT01024907|Procedure|quality-of-life assessment|Ancillary study
16247741|NCT01024907|Other|questionnaire administration|Ancillary study
16247742|NCT01024894|Drug|Interleukin-7|3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
16247743|NCT01024881|Procedure|neutral shoulder position|neutral shoulder position during infraclavicular subclavian catheterization
16247744|NCT01024881|Procedure|lowered shoulder position|lowered shoulder position during infraclavicular subclavian catheterization
16247745|NCT01024868|Drug|Ropivacaine 0,5%|Injection of ropivacaine 0,5% 20 ml bilaterally before surgery
16247746|NCT01024855|Device|RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)|multi-purpose lens care solution
16247747|NCT01024842|Biological|MVA.HIVconsv low dose|Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu at week 0, 4 and 12.
16247748|NCT01024842|Other|Placebo low dose|Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.
16247749|NCT01024842|Biological|MVA.HIVconsv high dose|Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu at week 0, 4 and 12.
16247750|NCT01024842|Other|Placebo high dose|Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.
16247751|NCT01024829|Radiation|Radiotherapy|Radiotherapy
16247752|NCT01024816|Behavioral|Restorative yoga|"Group yoga sessions: Participants will attend 90 minute yoga group classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. We plan a progressive series of classes, with a subset of poses for each class and then selecting individual poses to focus on in each class.
~Home yoga practice: Participants will be given a video disk (DVD) of the yoga postures at the start of the yoga intervention practice. We will also provide the yoga participants with a written manual with pictures and descriptions of each posture that they will be taught in the group sessions. The participants will be asked to practice the postures taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given a set of yoga props for their use at home. We will ask all participants to keep a log of their home practice sessions"
16247995|NCT01022918|Drug|Temodal/radiotherapy|
16247753|NCT01024816|Behavioral|Stretching|"Group classes: Participants will attend 90 minute group stretching classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. The stretches will address all body parts, including cervical, upper extremity, thoracic, lumbar, pelvic, and lower extremity musculature.
~Home stretching practice: Each participant will receive a written manual with pictures and descriptions of each stretch that they will be learning in group sessions and a DVD with instruction on each of the stretches. The participants will be asked to practice the stretches taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given stretching supplies. We will ask all participants to keep a log of their home practice sessions."
16247754|NCT01024803|Device|"Device name: Retina Implant model Alpha. Surgical implantation of medical device into eye"|"Surgical implantation of medical device named Retina Implant into eye to restore vision partially.
~Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL."
16247755|NCT01024790|Behavioral|Exercise group|24 week group exercise class supplemented with behavioral activation strategies
16247756|NCT01024777|Drug|Cholecalciferol|Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
16247757|NCT01024777|Drug|Cholecalciferol|Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
16247758|NCT01024751|Device|Bausch & Lomb Multi-Purpose Solution|Lens care product for disinfecting lenses on a daily basis.
16247759|NCT01024751|Device|Ciba's Multi-Purpose Solution|Lens care product for disinfecting lenses on a daily basis.
16247760|NCT01024738|Drug|Fluoride|Brush half mouth twice daily for four days.
16247761|NCT01024738|Drug|Triclosan, fluoride|Brush twice daily
16247762|NCT01024738|Drug|Chlorhexidine Gluconate|Rinse mouth twice a day
16247763|NCT01024725|Other|Follow-up|Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
16247764|NCT01024712|Drug|carboplatin|
16247765|NCT01024712|Drug|gefitinib|
16247766|NCT01024712|Drug|paclitaxel|
16247767|NCT01024712|Procedure|quality-of-life assessment|
16247768|NCT01024686|Biological|p52-/p36- GAP Vaccine|Administered by five bites from GAP-infected Anopheles mosquito
16247769|NCT01024686|Biological|p52-p36- GAP Vaccine|Administered by 200 bites from GAP-infected Anopeles mosquito
16247770|NCT01024686|Biological|p52-/p36- GAP Vaccine|Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito
16247771|NCT01024660|Drug|Donepezil|5 mg capsule, orally, once daily, first 14 days of treatment
16247772|NCT01024660|Drug|Donepezil|10 mg, orally, once daily, for remaining 70 days of treatment
16247773|NCT01024660|Drug|Placebo to match Aricept|Placebo capsule, orally, 84 days of treatment
16247774|NCT01024647|Biological|certolizumab pegol|certolizumab pegol 200 mg every 2 weeks
16247775|NCT01024647|Biological|certolizumab pegol|certolizumab pegol 400 mg every 2 weeks
16247776|NCT01024647|Biological|certolizumab pegol|certolizumab pegol 400 mg every 4 weeks
16247777|NCT01024647|Biological|certolizumab pegol|certolizumab pegol 400 mg every 2 weeks
16247778|NCT01024634|Behavioral|Endurance Exercise|8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session
16247779|NCT01024621|Device|Endomicroscope|Pentax EC3870K, Tokyo, Japan
16247780|NCT01024621|Device|Standard endoscopy|Pentax EG-2931 gastroscope
16247781|NCT01024608|Drug|Beclomethasone dipropionate|Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
16247782|NCT01024608|Drug|Placebo Nasal Aerosol|Placebo nasal aerosol administered each morning for two weeks.
16247783|NCT01024582|Procedure|biopsy|before treatment a biopsy will be taken to confirm breast cancer type
16247784|NCT01024582|Procedure|fine-needle aspiration|at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
16247785|NCT01024582|Radiation|accelerated partial breast irradiation|
16247786|NCT01024582|Radiation|image-guided radiation therapy|
16247787|NCT01024569|Behavioral|Wellness Recovery Action Planning (WRAP)|WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.
16247788|NCT01024543|Drug|Angiotensin II|Angiotensin II
16247789|NCT01024543|Drug|Phenylephrine|Phenylephrine
16247790|NCT01024543|Drug|Placebo|
16247791|NCT01024517|Drug|GLPG0259 solution|single oral dose, GLPG0259, 50 mg oral solution
16247792|NCT01024517|Drug|GLPG0259|single oral dose, GLPG0259, 50 mg solid formulation
16247793|NCT01024504|Drug|Oxaliplatin|Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles
16247794|NCT01024504|Drug|Capecitabine|Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles
16247795|NCT01024504|Drug|Bevacizumab|Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
16247796|NCT01024491|Drug|paroxetine|daily dose of paroxetine 15mg for 12 weeks
16247797|NCT01024491|Drug|paroxetine|active daily treatment with paroxetine 20 mg
16247798|NCT01024491|Drug|placebo|active daily treatment with placebo
16247799|NCT01024465|Device|ReShape Duo Balloon|ReShape Duo Balloon
16247800|NCT01024452|Device|DAWN AC|computerized dosing management system for anticoagulation clinics
16247801|NCT01024452|Device|Hamilton Nomogram|simple nomogram for warfarin maintenance dosing
16247846|NCT01024036|Drug|Siltuximab|Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks
16247847|NCT01024036|Drug|Placebo|Placebo will be administered by 1-hour intravenous infusion every 3 weeks
16247848|NCT01024036|Drug|Best Supportive Care (BSC)|BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.
16247943|NCT01023282|Drug|Placebo|Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
16247802|NCT01024439|Procedure|transumbilical single incision laparoscopic appendicectomy|"Patients will undergo transumbilical single incision laparoscopic appendicectomy. A single incision is made on umbilicus within the margin of umbilical skin ring. Peritoneal cavity is entered by open method and the fascia layer can be extended up to 2.5cm in length. A single incision laparoscopic device (Olympus) will be inserted. Conventional laparoscopic instruments will be used. Umbilical fascia will be closed by PDS-1 J-shape needle. Marcain 0.5% should be infiltrated into the fascial layers as well as the skin layers with dosage up to 20ml. The umbilicus is reconstructed by interrupted 3-0 nylon by tacking the skin onto the fascia layers.
~Three non-transparent dressings will be placed as if conventional laparoscopic appendicectomy has been done."
16247803|NCT01024439|Procedure|conventional laparoscopic appendicectomy|"Patients will undergo conventional laparoscopic appendicectomy. A 10-mm subumbilical port will be inserted by open method. Two 5-mm working ports will be inserted under laparoscopic view at patient's left lower quadrant and suprapubic area. Umbilical fascia will be closed by PDS-1 J-shape needle.
~Local anaesthetic agent , Marcain 0.5% should be infiltrated into the fascial layers as well as the skin layers with dosage up to 20ml. All skin wound will be approximated with 3-0 nylon interrupted stitches and covered with non-transparent dressings."
16247804|NCT01024426|Procedure|Enhanced health facility-based care|The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs.
16247805|NCT01024426|Other|Standard care|In the clusters randomized to standard care, standard care will include services typically provided by government-run facilities; we will not provide any additional support to these facilities. Health care will be provided to patients attending these facilities according to the usual standards; in-charges will continue to manage the facilities using their standard approach, no additional training will be provided to the health workers stationed at these facilities; and no support for staffing or supplies will be provided beyond what is supplied by the district and MoH.
16247806|NCT01024413|Drug|erlotinib|study arm.erlotinib 150 mg oral till disease progression
16247807|NCT01024413|Drug|gefitinib|study arm.gefitinib 250 mg oral till disease progression
16247808|NCT01024400|Biological|Non-adjuvanted A(H1N1)v influenza vaccine|15 mcg HA/0.5 ml
16247809|NCT01024387|Drug|AMG 479|
16247810|NCT01024361|Device|CPAP|CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
16247811|NCT01024348|Drug|extended-release tramadol|30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
16247812|NCT01024348|Drug|paracetamol|in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
16247813|NCT01024335|Drug|injectable naltrexone and dronabinol|Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
16247814|NCT01024335|Drug|Naltrexone and placebo|Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
16247815|NCT01024322|Drug|Ciprofloxicine or Vigamox or other.|Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
16247816|NCT01024322|Drug|Nonsteroidal (Acular, Voltaren Xibrom, etc)|Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
16247817|NCT01024322|Drug|Steroid (FML, Pred Forte, Flarex, etc.)|Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.
16247818|NCT01024309|Procedure|Mini-Posterior surgical approach for total hip arthroplasty|Mini-Posterior surgical approach for total hip arthroplasty
16247819|NCT01024309|Procedure|Direct Anterior surgical approach for total hip arthroplasty|Direct Anterior surgical approach for total hip arthroplasty
16247820|NCT01024296|Device|Port Close|Device for applying loop suture to close surgical site
16247821|NCT01024270|Drug|Misoprostol|
16247822|NCT01024257|Radiation|beta-irradiation|
16247823|NCT01024257|Procedure|conjunctival autograft|
16247824|NCT01024244|Drug|Placebo|Administered po BID, prior to morning and evening meals for 12 weeks.
16247825|NCT01024244|Drug|LY2599506|Administered po for 12 weeks
16247826|NCT01024231|Drug|BMS-936558 (MDX1106-04)|
16247827|NCT01024231|Drug|Ipilimumab|
16247828|NCT01024218|Device|NovoFine® needle 8 mm|
16247829|NCT01024218|Device|autocover needle|
16247830|NCT01024205|Drug|sunitinib malate|
16247831|NCT01024205|Other|laboratory biomarker analysis|
16247832|NCT01024205|Procedure|adjuvant therapy|
16247833|NCT01024205|Procedure|neoadjuvant therapy|
16247834|NCT01024205|Procedure|therapeutic conventional surgery|
16247835|NCT01024192|Drug|ZOLPIDEM SL800750|"Pharmaceutical form: Zopidem 12.5 mg tablets
~Route of administration: Oral
~Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)"
16247836|NCT01024179|Device|Polymer-based sirolimus-eluting stent (Partner stent )|Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery
16247837|NCT01024166|Behavioral|Questionnaire and Review Session|Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete. Review session about use of computer system and suggested changes.
16247838|NCT01024166|Behavioral|Questionnaire and Review Session|Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete. Review session about use of computer system and suggested changes.
16247839|NCT01024153|Behavioral|Active video game play|Children will get a Wii video game console and one game at week one and another at week 7. We will monitor their video game play and physical activity during this time.
16247840|NCT01024140|Drug|Escitalopram|Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.
16247841|NCT01024127|Other|Laboratory Biomarker Analysis|Correlative studies
16247842|NCT01024101|Drug|Paclitaxel|Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
16247843|NCT01024075|Drug|Dexamethasone|4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam
16247849|NCT01024023|Device|EWA|Suitable participants randomised to the treatment arm to receive early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed.
16247850|NCT01024010|Drug|Cyclophosphamide|Given IV
16247851|NCT01024010|Other|Laboratory Biomarker Analysis|Correlative studies
16247852|NCT01024010|Biological|Ofatumumab|Given IV
16247853|NCT01024010|Drug|Pentostatin|Given IV
16247854|NCT01023984|Procedure|TEM - Transanal Endoscopic Microsurgery|TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.
16247855|NCT01023984|Procedure|ESD - Endoscopic Submucosal Dissection|an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.
16247856|NCT01023958|Drug|BI 6727, IV infusion|phase II
16247857|NCT01023945|Drug|ASP1941|oral
16247858|NCT01023945|Drug|Placebo|oral
16247859|NCT01023932|Device|Cochlear Implants|
16247860|NCT01023919|Device|Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)|Cypher stent or YinYi stent randomly implanted in coronary artery disease
16247861|NCT01023880|Drug|CEP-18770|CEP-18770 beginning at a dose of 1.5 mg/m2. Patients will receive I.V. administration on days 1, 8, 15 (up to 8 cycles of 28 days each). When the MTD is established, additional patients will be treated at the MTD.
16247862|NCT01023867|Drug|donepezil|from 5mg to 10mg, once a day, 12 months
16247863|NCT01023854|Procedure|Continuous Paravertebral block|"The paravertébral block is a peripheral block which gets an one-sided continuous analgesia by infiltration of the spinal nerves which appear from the intervertebral foramen.
~Its realization consists of a draining in 2-3 cm of the thorny apophyses ( T6-T8). During the perception of the osseous contact (cross-functional process of the vertebra), the needle is redirected in cephalic direction until a loss of resistance corresponding to the passage of the upper costo-cross-functional ligament that is in the entrance to the paravertébral space. A catheter is then inserted into the paravertébral space."
16247864|NCT01023841|Drug|bimatoprost ophthalmic solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
16247865|NCT01023841|Drug|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
16247866|NCT01023815|Drug|everolimus|Everolimus (Certican®) was provided in blisters containing tablets of 0.25 mg and 0.75 mg. Everolimus was initiated within 48 hours after graft reperfusion and it was administered orally.
16247867|NCT01023815|Drug|cyclosporine|Cyclosporine for microemulsion (CsA, Sandimmun® Neoral®) was coadministered with everolimus at the same time of the day. CsA was available in alu-alu blisters containing soft gelatine capsules of 100 mg, 50 mg, 25 mg and 10 mg. Oral solution, as bottles containing 50 mL of solution (100 mg/mL) has been provided and used in case the drug had been administered to patients by nasogastric tube immediately after transplant.
16247868|NCT01023815|Drug|Prednison (continuous steroids)|continuous steroids
16247869|NCT01023789|Device|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
16247870|NCT01023776|Biological|A/California/07/09 live monovalent H1N1 vaccine|0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
16247871|NCT01023763|Other|A structured training program|A structured training program in nursing homes in the intravenous treatment of dehydration and infections.
16247872|NCT01023750|Drug|Fenofibrate|Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.
16247873|NCT01023737|Drug|Hydroxychloroquine|The HCQ study dose levels are defined as 400mg/day, 600mg/day, 800mg/day and 1000mg/day (oral dosing)during the phase I MTD determination. HCQ will be administered starting on Day 2 of Cycle 1 and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
16247874|NCT01023737|Drug|Vorinostat|Oral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
16247875|NCT01023724|Drug|Ketorolac Tromethamine 0.45%|Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.
16247876|NCT01023724|Drug|Bromfenac 0.09%|Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
16247877|NCT01023711|Biological|Inactivated H1N1 vaccine|0.5 ml IM into Deltoid region of arm
16247878|NCT01023711|Biological|Inactivated H1N1 vaccine|0.5 mL IM X 1 dose
16247879|NCT01023698|Procedure|laser photocoagulation|Laser photocoagulation
16247880|NCT01023685|Biological|CAD106|
16247881|NCT01023672|Drug|Armodafinil|150-250 mg armodafinil by mouth daily
16247882|NCT01023659|Drug|bupropion|bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
16247883|NCT01023659|Drug|varenicline|varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
16247884|NCT01023659|Behavioral|motivational emails|brief motivational emails, sent weekly for 12 weeks
16247885|NCT01023646|Other|Carbohydrate + Protein|Light Tuna Packed in water.
16247886|NCT01023646|Other|Carbohydrate + Fat|Butter
16247889|NCT01023633|Drug|Oxaliplatin, LV, 5-FU|"Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles.
~FOLFOX4 regimen:
~OXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W"
16247890|NCT01023620|Drug|Pioglitazone|Participants will take oral Pioglitazone 45 mg daily for 16 weeks.
16247891|NCT01023620|Other|Observation|Participants will be observed for 16 weeks but will not receive drug
16247892|NCT01023607|Drug|Atorvastatin|Atorvastatin 20mg/day
16247893|NCT01023607|Drug|Atorvastatin|Atorvastatin, 60mg/day
16247894|NCT01023607|Drug|Rosuvastatin|Rosuvastatin,10mg/day
16247895|NCT01023594|Procedure|Pancreatic stent|Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.
16247896|NCT01023581|Drug|Alogliptin|Alogliptin tablets.
16247897|NCT01023581|Drug|Metformin|Metformin capsules
16247898|NCT01023581|Drug|Alogliptin Placebo|Alogliptin placebo-matching tablets.
16247899|NCT01023581|Drug|Metformin Placebo|Metformin placebo-matching capsules.
16247900|NCT01023568|Device|Macintosh blade|Intubation with Macintosh blade laryngoscope
16247901|NCT01023568|Device|Glidescope|Intubation with Glidescope laryngoscope.
16247902|NCT01023568|Device|Truview PCD|Intubation with Truview PCD laryngoscope.
16247903|NCT01023555|Other|1cc of blood in a single aerobic culture bottle|The efficacy of using 1cc of blood in a single aerobic bottle for cultures in neonatal bacteremia will will be compared with the traditional 0.5cc of blood in 2 Bottles
16247904|NCT01023542|Drug|delayed, low-dose CNI|immunosuppression
16247905|NCT01023542|Drug|BU-CNI|Immunosuppression
16247906|NCT01023542|Drug|BU-Everolimus|Immunosuppression
16247907|NCT01023529|Radiation|Palliative pelvic soft-tissue radiation (external beam)|3 Gy x 10-13 (range 30 - 39 Gy total)
16247908|NCT01023516|Drug|AZD9668|2 x 30 mg oral tablets bd for 12 weeks
16247909|NCT01023516|Drug|Placebo|2 x matched placebo to oral tablet bd for 12 weeks
16247910|NCT01023490|Drug|Vitamin D|34,5000 IU vitamin D per week
16247911|NCT01023490|Drug|Placebo|Placebo
16247912|NCT01023477|Drug|Chloroquine Standard Dose (500mg/week)|Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.
16247913|NCT01023477|Drug|Chloroquine Low Dose (250mg/week)|Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.
16247914|NCT01023477|Procedure|Breast Biopsy|Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery.
16247915|NCT01023464|Other|FID114657|artificial tears
16247916|NCT01023464|Other|SootheXP Emollient (Lubricant) Eye Drops|artificial tears
16247917|NCT01023438|Other|Strategy for assisted uptitration|Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
16247918|NCT01023438|Other|Usual care|Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided
16247919|NCT01023425|Drug|donepezil|from 5mg to 10mg, once a day, 12 months
16247920|NCT01023412|Dietary Supplement|Immunonutrition|Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
16247921|NCT01023399|Drug|Artesunate + Amodiaquine|Artesunate + Amodiaquine fixed dose combination
16247922|NCT01023386|Drug|YM155|I.V.
16247923|NCT01023373|Drug|Medical treatment|hypotensive drugs, statins and anti-platelets
16247924|NCT01023373|Procedure|PTRS|Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS
16247925|NCT01023373|Device|renal artery stent|Non-drug intervention, percutaneous transluminal renal artery stent angioplasty
16247926|NCT01023373|Device|renal artery stent|Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy
16247927|NCT01023360|Drug|Clopidogrel and proton pump inhibitors|"baseline detection --> clopidogrel 75 mg PO QD for 1 week --> clopidogrel 75 mg plus rabeprazole 20mg PO QD for 1 week --> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --> clopidogrel 75 mg plus pantoprazole 40mg PO QD for 1 week --> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --> clopidogrel 75 mg plus esomeprazole 40mg PO QD for 1 week -->
~1 week washout --> aspirin 100mg PO QD for 1 week"
16247928|NCT01023347|Drug|Paclitaxel (Genexol®)|
16247929|NCT01023347|Drug|Paclitaxel loaded polymeric micelle (Genexol-PM®)|
16247930|NCT01023334|Procedure|MSICS under topical anesthesia with intracameral lidocaine|manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine
16247931|NCT01023334|Procedure|MSICS under topical anesthesia with intracameral balanced salt solution.|manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.
16247932|NCT01023321|Drug|GLPG0555|single ascending doses, oral solution
16247933|NCT01023321|Drug|placebo|single dose, oral solution
16247934|NCT01023321|Drug|GLPG0555|multiple dose, oral solution, 7 or 14 days
16247935|NCT01023321|Drug|placebo|multiple dose, oral solution, 7 or 14 days
16247936|NCT01023308|Drug|Panobinostat|Panobinostat was administered 3x week ( 2 weeks on 1 week off)
16247937|NCT01023308|Drug|Bortezomib|Bortezomib was administered 2 x week ( 2weeks on 1 week off)
16247938|NCT01023308|Drug|Dexamethasone|Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
16247939|NCT01023308|Drug|Placebo|Placebo was administered 3x week ( 2 weeks on 1 week off)
16247940|NCT01023295|Drug|fosbretabulin|single dose, intravenous infusion
16247941|NCT01023295|Drug|Saline|single dose, intravenous infusion
16247942|NCT01023282|Drug|ACR325|Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
16247944|NCT01023269|Device|InterStim Therapy|Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
16247945|NCT01023256|Drug|MOR103|MOR103 0.3 mg/kg or placebo iv x 4 doses
16247946|NCT01023256|Drug|MOR103|MOR103 1.0 mg/kg or placebo iv x 4 doses
16247947|NCT01023256|Drug|MOR103|MOR103 1.5 mg/kg or placebo iv x 4 doses
16247948|NCT01023243|Other|Brochure: Care of the Feet for Those at Risk|Patient education materials and key messages for care of the feet for those patients at risk
16247949|NCT01023243|Other|Quality Survey: foot exam, tobacco and aspirin use|NCQA Patient Survey
16247950|NCT01023230|Drug|DV-601|Six injections of DV-601 administered over a period of 12 weeks.
16247951|NCT01023230|Drug|Entecavir|Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
16247952|NCT01023217|Drug|Adefovir|Adefovir dipivoxil (Hepsera) 10 mg/day orally for 104 weeks
16247953|NCT01023217|Drug|Entecavir|Entecavir 1 mg/day orally
16247954|NCT01023217|Drug|Lamivudine|Lamivudine (Zeffix) 100 mg/day orally
16247955|NCT01023204|Drug|Paclitaxel|Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
16247956|NCT01023191|Procedure|Percutaneous Insertion catheter|Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
16247957|NCT01023191|Procedure|Open insertion Catheter|Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.
16247958|NCT01023178|Drug|17beta Estradiol|Oral pill given daily at increasing doses every 6 months for 18 months.
16247959|NCT01023178|Drug|Conjugated estrogens|Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
16247960|NCT01023178|Drug|17Beta Estradiol - transdermal|Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
16247961|NCT01023178|Drug|Progesterone, micronized|Given starting at 18 months
16247962|NCT01023165|Procedure|Humulin, Humalog, Novolog|Supervising Physician reviews patient activation after intravenous bolus insulin treatment each week and adjusts the amounts of insulin and carbohydrates to be given in the next treatment session based on patient treatment outcomes.
16247963|NCT01023152|Procedure|Automated cuff-inflator|RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.
16247964|NCT01023139|Behavioral|Sibutramine|During phase 1, sibutramine is given to all participants, 10mg po q day. If they do not meet a change in BMI of at least 2.5%,then the dosage may be increased to 15mg po q day. The main intervention in the study during phase 1 and 2is the behavioral modification
16247965|NCT01023126|Behavioral|Group Psychotherapy|Group psychotherapy once a week, under a psychiatrist supervision
16247966|NCT01023113|Procedure|PASCAL laser|PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
16247967|NCT01023113|Procedure|Conventional laser|PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
16247968|NCT01023100|Drug|CP 690,550 oral solutions|flavored and unflavored prototype CP-690,550 formulations
16247969|NCT01023087|Drug|Polymyxin E (Colistin)|Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.
16247970|NCT01023087|Drug|Non-nephrotoxic antibiotics|To be decided by the infectious disease consultant
16247971|NCT01023074|Behavioral|Auditory training|the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.
16247972|NCT01023074|Other|MS: Control Activity|MS group not receiving auditory training, doing control activity
16247973|NCT01023061|Drug|abiraterone acetate|Given PO
16247974|NCT01023061|Drug|prednisone|Given PO
16247975|NCT01023061|Drug|leuprolide acetate|Given via injection
16247976|NCT01023061|Other|laboratory biomarker analysis|Correlative study
16247977|NCT01023061|Radiation|external beam radiation therapy|Undergo radiotherapy
16247978|NCT01023061|Drug|goserelin acetate|Given via injection
16247979|NCT01023048|Other|preimplantation diagnosis|genetic testing on embryos to identify embryos that are affected by a single gene disorder (e.g. cystic fibrosis, Tay-Sachs, sickle cell anemia)
16247980|NCT01023035|Drug|Boceprevir|800 mg given three times a day (TID), orally (PO)
16247981|NCT01023035|Drug|Peginterferon alfa-2b (PEG2b)|1.5 µg/kg/week given subcutaneously (SC)
16247982|NCT01023035|Drug|Ribavirin (RBV)|Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)
16247983|NCT01023035|Drug|Erythropoietin|Initial dose of 40,000 Units given subcutaneously (SC) once weekly (QW), with dose adjustment as necessary to achieve and maintain serum hemoglobin levels of 10-12 g/dL
16247984|NCT01023022|Other|Medtronic CareLink® Network|The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website
16247985|NCT01023009|Procedure|vitrectomy|
16247986|NCT01022996|Drug|Everolimus (RAD001)|Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
16247987|NCT01022983|Drug|Levosimendan|At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
16247988|NCT01022983|Drug|Placebo|ml/kg/hours - same infusion rate as active comparator
16247989|NCT01022970|Drug|QAX576 placebo|
16247990|NCT01022970|Drug|QAX576|
16247991|NCT01022957|Genetic|genetic diagnosis|to determine the long term evolution of Nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation
16247992|NCT01022944|Procedure|With chronic middle ear effusion|Children with chronic middle ear effusion having adenoidectomy.
16247993|NCT01022944|Procedure|Without chronic middle ear effusion|Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.
16247994|NCT01022918|Drug|Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures)|
16247996|NCT01022905|Biological|Adjuvanted influenza A(H1N1) vaccines|Immunization (1-2 doses)
16247997|NCT01022879|Procedure|vitrectomy|
16247998|NCT01022853|Drug|BI 6727|intravenous each 21 days
16247999|NCT01022853|Drug|BIBF 1120|oral continuously
16248000|NCT01022840|Drug|S-Ketamine|drug
16248001|NCT01022840|Other|Placebo Comparison|saline control
16248002|NCT01022827|Other|massage|For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
16248003|NCT01022814|Device|A disposable pad containing sensitive chemical indicators|After a urine/amniotic fluid leaking, liquid meets the diagnostic device and chemical reactions will occur in the test zones and cause a color change.
16248004|NCT01022801|Drug|Entecavir|Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
16248005|NCT01022788|Behavioral|Home-based counselling|
16248006|NCT01022775|Procedure|Dynamic humeral centering|Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
16248007|NCT01022775|Procedure|Nonspecific mobilisation|Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
16248008|NCT01022762|Drug|repaglinide|Individually adjusted dose for 16 weeks
16248009|NCT01022762|Drug|gliclazide|Individually adjusted dose for 16 weeks
16248010|NCT01022749|Drug|Vaccine|MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)
16248011|NCT01022749|Biological|Vaccine anti-H1N1|patients who received the vaccine anti-H1N1
16248012|NCT01022736|Drug|Gabapentin|Subjects will be administered gabapentin (600 mg, orally) 1 hour prior to cardiac bypass surgery, 1 hour following extubation, then every 8 hours for a total of 4 doses.
16248013|NCT01022697|Other|Glucose drink|200 mL each 3 hours up to 8 cm of dilatation
16248014|NCT01022684|Other|Cross section study|This is not intervention study. The purpose of the study is to examine the relationship between various inflammatory markers and PET imaging at the cross section setting
16248015|NCT01022671|Drug|Belotecan|3.0 mg/m2, Day 1, 8, 15 every 4 weeks
16248016|NCT01022658|Drug|Insulin|For diabetes treatment: metformin continued with insulin (according to arms)
16248017|NCT01022645|Device|Mirena (Levonorgestrel IUD)|Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use
16248018|NCT01022645|Device|Paragard (Copper IUD ) or Tubal Ligation|Copper IUD placed to provide contraception for up to 10 years
16248019|NCT01022632|Dietary Supplement|Curcumin|Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks
16248020|NCT01022632|Drug|Fluoxetine|Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks
16248021|NCT01022632|Dietary Supplement|Curcumin and Fluoxetine|Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
16248022|NCT01022606|Other|Arterial sampling|Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
16248023|NCT01022580|Drug|Infasurf surfactant (ONY, Inc.)|Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
16248024|NCT01022580|Drug|Sham (No Treatment)|Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
16248025|NCT01022567|Procedure|Appendicectomy|Standard appendicectomy
16248026|NCT01022567|Drug|Ertapenem|ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.
16248027|NCT01022541|Drug|Capecitabine|"Capecitabine 1700mg/m2/day in two divided doses to be administered orally for 14 days followed by 7 days rest. For 4 courses initially.
~(For patients aged 75+ 1300mg/m2/day in two divided doses or 650mg/m2 twice daily)
~Courses as per detailed description above."
16248028|NCT01022541|Drug|Oxaliplatin|"Oxaliplatin 130mg/m2 diluted in 5% dextrose will be given as an i.v. infusion over 2 hours. This will be administered on day 1 after bevacizumab. For 4 courses.
~(Patients aged 75+ should receive oxaliplatin at a reduced dose i.e. 100mg/m2)
~Courses as per detailed description above."
16248029|NCT01022541|Drug|Bevacizumab|"Bevacizumab at a dose of 7.5 mg/kg, diluted in normal saline, will be administered as an iv infusion over 30 to 90 minutes before the administration of oxaliplatin on day 1 of every cycle.
~The first infusion should be administered over 90 minutes. If well tolerated, the second infusion can be administered over 60 minutes. Provided that this is tolerated subsequent infusions can be administered over 30 minutes. If a patient experiences an infusion related adverse event with the 60 minute infusion, all subsequent infusions will be administered over 90 minutes. If a patient experiences an infusion related reaction with the 30 minute infusion, all subsequent infusions will be administered over 60 minutes
~Courses as per detailed description above."
16248030|NCT01022541|Procedure|Liver metastasectomy|Patients with liver metastases which have become resectable and in whom surgery is still deemed appropriate should proceed to surgery after a 6 week interval from the last administration of capecitabine chemotherapy (at least 8 weeks from last administration of bevacizumab).
16248031|NCT01022528|Drug|Dexamethasone (0.1 mg/kg)|
16248032|NCT01022528|Drug|Dexamethasone (0.2 mg/kg)|
16248033|NCT01022528|Other|Saline|
16248034|NCT01022515|Other|plasma EM66 & CgA levels assessment|After inclusion checking to eliminate the presence of pheochromocytoma / paraganglioma, a blood sample will be drawn to assess plasma EM66 and CgA levels.
16248035|NCT01022515|Other|usual follow up with regular EM66 & Cga levels assessment|"Patients with pheochromocytoma / paraganglioma will be followed-up as the international standards recommend.
~Regularly, blood samples will be drawn for the usual assessment of CgA levels and also EM66 (research purpose) levels."
16248036|NCT01022502|Drug|refined indigo naturalis ointment|The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
16248037|NCT01022502|Drug|crude indigo naturalis ointment|The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
16248038|NCT01022489|Device|Transcranial magnetic stimulation: rTMS|4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
16248039|NCT01022489|Device|Placebo (sham coil) treatment|Sham coil treatment
16248040|NCT01022476|Drug|Raltegravir potassium|one pill of raltegravir 400 mg twice a day
16248041|NCT01022463|Drug|Ivabradine|Ivabradine 5 mg BId for 4 weeks
16248042|NCT01022463|Drug|Atenolol|50 mg od for 4 weeks
16248043|NCT01022437|Other|Geranium Oil with component PN-34|Geranium oil as a topical application to the body that is numb, time to determine how long it takes for the feeling to return, if it does so, and if the return of feeling is maintained by daily topical application of oil over 12 weeks. This including the process of absorption, distribution and localization.
16248044|NCT01022424|Drug|OPC-41061|Repeated oral administration at doses of 15 mg twice daily (morning and evening)
16248045|NCT01022411|Dietary Supplement|Brown rice/White rice|ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks
16248046|NCT01022398|Drug|cholecalciferol/placebo|10,000 IU by mouth weekly for 6 months
16248047|NCT01022385|Dietary Supplement|24-hour low-residual diet|
16248048|NCT01022372|Procedure|Endometrial biopsy|For all the groups
16248049|NCT01022359|Device|TesioCath|Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
16248050|NCT01022359|Device|LifeCath Twin|Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
16248051|NCT01022346|Drug|Placebo|Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
16248052|NCT01022346|Drug|RO5217790|RO5217790 will be administered at a dose of 5*10^7 pfu subcutaneously on Days 1, 8, and 15.
16248053|NCT01022333|Dietary Supplement|Diindolylmethane (DIM)|300 mg per day of DIM for six weeks.
16248054|NCT01022320|Procedure|Lateral Pharyngoplasty|surgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally.
16248055|NCT01022294|Drug|Nitrousoxide-oxygen and atmospheric air|Nitrousoxide-oxygen and atmospheric air
16248056|NCT01022294|Drug|Atmospheric air; nitrousoxide-oxygen|Atmospheric air; nitrousoxide-oxygen
16248057|NCT01022255|Biological|Autologous FL vaccine|1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16)
16248058|NCT01022242|Drug|PXL01|PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
16248059|NCT01022242|Drug|Placebo|Placebo is a physiological sodium chloride solution, which is clear and colourless.
16248060|NCT01022229|Dietary Supplement|Compound Natural Health Product|"15-35 mg zinc citrate
~150-350 mg magnesium lactate
~30-70 mg pyridoxine hydrochloride
~150-350 mg calcium ascorbate
~Doses are weight based. Chewable tablets are taken 2 times/day with food for the duration of the study"
16248061|NCT01022229|Dietary Supplement|Placebo|Placebo
16248062|NCT01022216|Device|Procellera™ Wound Dressing with V.A.C.® Therapy|Dressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT.
16248063|NCT01022216|Device|V.A.C.® Therapy|Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.
16248064|NCT01022203|Behavioral|Structured Approach Therapy|The Structured Approach Therapy intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach Veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication.
16248065|NCT01022203|Other|PTSD Family Education|The PTSD Family Education intervention provides education for Veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included.
16248066|NCT01022190|Drug|Etoricoxib (Arcoxia)|Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
16248067|NCT01022177|Procedure|acupuncture|acupuncture of the eye in traditional chinese schematics
16248068|NCT01022164|Procedure|fibrin glue|
16248069|NCT01022151|Drug|Placebo [group P]|receive intravenous injection of 0.2 mL/kg of saline 0.9%L [group P]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248070|NCT01022151|Drug|0.2 mL/kg of aminophylline 10 mg/mL [group A2]|receive intravenous injection of 0.2 mL/kg of aminophylline 10 mg/mL [group A2]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248071|NCT01022151|Drug|0.2 mL/kg of aminophylline 15 mg/mL [group A3]|receive intravenous injection of 0.2 mL/kg of aminophylline 15 mg/mL [group A3]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248072|NCT01022151|Drug|0.2 mL/kg of aminophylline 20 mg/mL [group A4]|receive intravenous injection of 0.2 mL/kg of aminophylline 20 mg/mL [group A4]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248073|NCT01022151|Drug|0.2 mL/kg of aminophylline 25 mg/mL [group A5]|receive intravenous injection of 0.2 mL/kg of aminophylline 25 mg/mL [group A5]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248074|NCT01022151|Drug|Doxapram 1 mg/kg [group D]|receive intravenous injection of 0.2 mL/kg of doxapram 5 mg/mL [group D]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.
16248075|NCT01022138|Biological|HER2Bi-armed activated T cells|Immediately after pheresis, the lymphocytes are activated with soluble monoclonal anti-CD3 antibody, which cross-links the CD3 receptors on T cells and activates them.
16248076|NCT01022138|Drug|Cyclophosphamide|After recovering from the last cycle of chemotherapy (approx. two-four weeks) patients will be re-staged. If there are no residual chemotherapy related toxicities, they will be given lymphodepleting chemotherapy consisting of one dose of Cyclophosphamide 1.0 gm/m2 on day -7. Appropriate anti-emetics will be given as pre-medications before the dose of Cyclophosphamide
16248077|NCT01022138|Other|Laboratory biomarker analysis|The association between the [18F]-FDG PET/CT assessments (percent changes from baseline in SUVpeak) and immunologic biomarker changes as well as tumor response will be explored.
16248078|NCT01022125|Drug|TMC435|
16248079|NCT01022112|Drug|TA-7284-Low|TA-7284-Low
16248080|NCT01022112|Drug|TA-7284-Low-middle|TA-7284-Low-middle
16248081|NCT01022112|Drug|TA-7284-High-middle|TA-7284-High-middle
16248082|NCT01022112|Drug|TA-7284-High|TA-7284-High
16248083|NCT01022112|Drug|Placebo|Placebo
16248084|NCT01022099|Procedure|Implantation of a Total Knee Arthroplasty|"In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases.
~The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation.
~The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides."
16248085|NCT01022086|Procedure|Cardiac MRI|Cardiac magnetic resonance (CMR) imaging, otherwise called a cardiac (heart) MRI is a safe and standard clinical test that creates detailed images of your heart. It uses a computer to create images of your heart as it is beating, producing both still and moving pictures of your heart and major blood vessels. This test will allow the health professionals to obtain images of your beating heart and to look at the structure and function. Cardiac MRIs can help diagnose and evaluate a number of diseases conditions (such as heart failure, and heart valve disease) and will help doctors decide how to treat or manage patients who have heart problems.
16248086|NCT01022086|Biological|Biomarker Testing|"In addition to undergoing CMR imaging, patients will also have blood tests for two proteins, which serve as markers of heart injury and heart failure. These are called BNP and Troponin. These blood tests are currently used in clinical practice, but their precise role in monitoring heart function in cancer patients has not been well studied. Since the precise cause of Trastuzumab-induced heart damage is currently unknown, it is hoped that these two blood markers will provide valuable insights into how this happens.
~Peripheral venous blood samples will also be drawn at each CMR time-point. TGF β1, amino terminal propeptide of procollagen type I (PINP) and type III (PIIINP) and the carboxy-terminal telopeptide of collagen type 1 (CITP) will be measured by radioimmunoassay."
16248087|NCT01022060|Dietary Supplement|Renalof|One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
16248088|NCT01022060|Dietary Supplement|Placebo|One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
16248089|NCT01022047|Drug|Noex|The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
16248090|NCT01022047|Drug|Budecort Aqua|The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
16248091|NCT01022034|Procedure|sacral rectopexy with sutures or meshes|
16248092|NCT01022034|Procedure|full rectal mobilization from the sacrum without sacral rectopexy|
16248093|NCT01022021|Drug|Rituximab|Day 1 - rituximab, 375 mg/M2 IV (drug dosage is based on body weight)
16248094|NCT01022021|Drug|Bendamustine|Days 2 and 3 bendamustine, 90 mg/M2 IV over 30-60 minutes (drug dosage based on body weight)
16248095|NCT01022008|Device|Osteodistraction techniques|Treatment based on craniofacial osteotomies and osteodistraction techniques.
16248096|NCT01021995|Drug|echinacea|drops, 0.9 ml, tid for 4 months
16248097|NCT01021995|Drug|placebo|drops, 0.9 ml tid for 4 months
16248098|NCT01021969|Other|Fructose|Subjects consume different amounts of fructose, glucose and sucrose in a crossover design
16248099|NCT01021956|Drug|STAKEL|Open-label,safety and exploratory efficacy study in subjects with active CNV followed for 12 weeks.During first stage(dose escalating stage) subjects assigned to group 1 to 4 will receive a single treatment of VTP at one of three light levels and one of two Drug Light Interval (DLI).Second stage(dose confirmation)will be only initiated at a dose level in which an effect has been seen at week 1 and there is a maximum of one Dose Limiting Toxicity (DLT) out of three subject at week 5.
16248100|NCT01021943|Drug|spironolactone|Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
16248101|NCT01021943|Drug|Placebo|Half of the subjects will be assigned to receive placebo for 6 months
16248102|NCT01021930|Device|Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)|Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients
16248103|NCT01021904|Biological|Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)|0.5cc I/M Site deltoid Lt Rt 3-dose regimen: 0, 2, 6 months
16248104|NCT01021891|Drug|Technosphere®/Insulin|
16248105|NCT01021878|Other|icodextrin|glucose sparing dialysis solution
16248106|NCT01021878|Other|Dianeal|glucose based dialysis solution
16248107|NCT01021865|Drug|Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere|"GLP-1 at a rate of 1.2 pmol/kg/min
~Regadenoson as a stress agent 0.4mg IV given during MCE
~Definity:0.6 ml of Definity diluted with 30ml of 0.9% saline infused by SYRINGE Infusion Pump"
16248108|NCT01021852|Drug|MK-6096|MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.
16248109|NCT01021852|Drug|Dose-matched Placebo to MK-6096|Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
16248110|NCT01021839|Procedure|Grafts placement|Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
16248111|NCT01021813|Drug|Suvorexant|Oral tablet (30 mg and 10 mg), administered daily before bedtime
16248112|NCT01021813|Drug|Dose-matched Placebo to Suvorexant|Oral tablet, administered daily before bedtime
16248113|NCT01021800|Biological|MIS|Cell infusion
16248114|NCT01021787|Drug|Titanium dioxide|Topical cream
16248115|NCT01021774|Procedure|Anal fistula treatment|A comparison of collagen plug vs advancement flap surgery
16248116|NCT01021761|Drug|Ketorolac Tromethamine|ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
16248117|NCT01021761|Drug|Bromfenac|Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
16248118|NCT01021761|Drug|nepafenac|drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
16248119|NCT01021748|Drug|MK-2206|Oral tablets
16248120|NCT01021748|Drug|AZD6244|Oral capsules
16248121|NCT01021735|Drug|etanercept or adalimumab|etanercept 50mg/week by s/c injection adalimumab 40mg eow by s/c/ injection
16248122|NCT01021735|Drug|Rituximab|1g x2 by IV infusion repeated every 5 months or more
16248123|NCT01021722|Procedure|modified suture technique|Both internal and external anal sphincter was sutured separately end to end
16248124|NCT01021709|Device|tDCS (Eldith DC-Stimulator (CE certified))|tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm = 35 cm2 & 10 x 10 cm = 100 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
16248125|NCT01021696|Drug|Paracetamol|Paracetamol Max. dose: 3g/d
16248126|NCT01021696|Drug|Morphine|Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d
16248127|NCT01021696|Drug|Buprenorphine plaster|5ųg/h, change each 7.day; max. dose: 10ųg/h
16248128|NCT01021696|Drug|Pregabalin|25mgx1/d; max 300mg/d
16248129|NCT01021683|Drug|Itraconazole|Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered.
16248130|NCT01021670|Drug|Dapoxetine hydrochloride|One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks
16248131|NCT01021670|Other|Alternate care/non-dapoxetine hydrochloride treatment(s)|As prescribed or directed
16248132|NCT01021657|Procedure|trabeculectomies, non penetrating deep sclerectomies|
16248133|NCT01021644|Behavioral|aerobic exercise-training|3 times per week for 6 months
16248134|NCT01021644|Behavioral|stretch exercise|3 times per week for 6 months
16248135|NCT01021631|Other|Red blood cell transfusion|Red blood cell (RBC) transfusion will be given when hematocrit fall below 30% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 30% or higher, no additional transfusion is necessary.
16248136|NCT01021631|Other|Red blood cell transfusion|Red blood cell (RBC) transfusion will be only given when hematocrit fall below 24% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 24% or higher, no additional transfusion is necessary.
16248137|NCT01021618|Drug|Regadenoson|Regadenoson (0.4mg/5 mL) injection during symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
16248138|NCT01021618|Other|Symptom-limited exercise|Dipyridamole (0.56 mg/kg) over 4 minutes followed by symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
16248139|NCT01021605|Device|Hemolung Respiratory Assist System|Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive or invasive ventilation and then the Hemolung RAS. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
16248140|NCT01021592|Drug|bortezomib|Injection into a vein 1.3 mg/m2 twice a week for 21 days
16248141|NCT01021579|Drug|Metformin plus Placebo|PCOS patients(n=42) will be assigned to the placebo (once/day) plus metformin (500mg three times a day, n=42; group 2)
16248142|NCT01021579|Drug|Metfomin plus Simvastatin|
16248143|NCT01021566|Device|Combined hemoperfusion-hemodialysis|Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
16248144|NCT01021566|Drug|Methadone|On admission all patients will undergo a 3-day stabilization period. Then they will begin the 10-day methadone treatment regimen. The starting dose of methadone is determined by the mean daily dose requirement during the stabilization period and the dose will be reduced to zero at a linear rate over the 10 days treatment.
16248145|NCT01021553|Drug|GSK557296|50 mg GSK557296
16248146|NCT01021553|Drug|GSK557296|150 mg GSK557296
16248147|NCT01021553|Drug|placebo|placebo
16248148|NCT01021540|Drug|Repository corticotrophin|Acthar 80 IU SQ once a week and titrated up to twice a week
16248149|NCT01021527|Other|Comparator: Treatment A|No Treatment
16248150|NCT01021527|Drug|Comparator: Treatment B|single dose administration of exenatide 5ug by subcutaneous injection
16248151|NCT01021527|Drug|Comparator: Treatment C|single dose administration of exenatide 10ug by subcutaneous injection
16248152|NCT01021527|Procedure|Comparator: graded glucose infusion|A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
16248153|NCT01021501|Drug|nifedipine controlled release tablets|nifedipine controlled release tablets 60mg/day for at least 4 weeks
16248154|NCT01021488|Drug|Rosuvastatin 20mg/d for 14days|Rosuvastatin 20mg/day for 7days before and 7days after index surgery (total knee replacement arthroplasty, TKRA) Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered at the same time with rosuvastatin.
16248155|NCT01021488|Drug|enoxaparin only|enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
16248156|NCT01021475|Procedure|Visceral Manipulation|Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.
16248157|NCT01021475|Drug|PPIs and/or Domperidone|Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks
16248158|NCT01021462|Procedure|Comparator: graded infusion of intravenous glucose|A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.
16248159|NCT01021436|Drug|Amikacin inhalation solution (BAY41-6551)|Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour
16248160|NCT01021423|Drug|Lenalidomide|15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
16248161|NCT01021423|Other|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
16248162|NCT01021397|Drug|rHPIV3cp45|10^5 TCID50 nasal drops
16248163|NCT01021397|Drug|rHPIV3cp45 placebo|1X-L15 nasal drops
16248164|NCT01021384|Behavioral|Problem Solving Education|Problem Solving Education (PSE) is an evidenced-based empowerment strategy, targeted to mothers of young children to promote family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning.
16248165|NCT01021371|Behavioral|Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs|The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The control group is assigned to usual procedures.
16248166|NCT01021358|Drug|ABT-263|Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
16248167|NCT01021358|Drug|Ketoconazole|Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
16248168|NCT01021332|Drug|tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)|oral
16248169|NCT01021332|Drug|tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)|oral
16248170|NCT01021306|Device|Chiropractic w/Activator & Self Care|This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw.
16248171|NCT01021306|Device|Dental Care & Self Care|Following the dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions made. Interocclusal records will be made with a fast setting silicone using a metal tray. A commercial laboratory will then wax and heat process a clear acrylic resin splint attempting to capture the mandibular cusp tips in the occlusal plan of the splint. The splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. The splint will then be polished and home care instruction provided. Patients will be instructed to wear the splint at night and two hours per day.
16248172|NCT01021306|Other|Sham AMCT|This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient.
16248173|NCT01021306|Other|Self-Care Only Group|Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction.
16248174|NCT01021293|Biological|Poliorix™|3 doses, intramuscular administration
16248175|NCT01021293|Biological|Oral Poliovirus vaccine|3 doses, oral administration
16248176|NCT01021267|Drug|Saw palmetto berry extract|1x daily 1 capsule containing 320mg lipophilic extract
16248177|NCT01021241|Biological|Uricase-PEG 20|Intravenous infusion of Uricase-PEG 20 over one hour; no premedication
16248178|NCT01021215|Drug|Zileuton|1200 mg twice daily given orally (PO) for 6 days
16248179|NCT01021215|Drug|Celecoxib|200 mg twice daily given orally for 6 days
16248180|NCT01021215|Other|laboratory biomarker analysis|Correlative studies
16248181|NCT01021202|Procedure|Percutaneous dilation tracheostomy|Percutaneous dilation tracheostomy using Ciaglia blue rhino system (Cook medical, Limerick, IRELAND). Tracheostomy is conducted by two experienced physicians with (video-)bronchoscopic control and continuous monitoring of ECG, blood pressure, pulse and peripheral oxygen saturation.
16248182|NCT01021189|Drug|AZD1446|Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.
16248183|NCT01021189|Drug|Placebo|Oral solution Dose single and followed by 7-day multiple dosing.
16248184|NCT01021176|Other|Placebo spray|0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered
16248185|NCT01021176|Drug|Diltiazem|0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.
16248186|NCT01021163|Drug|N-acetylcysteine, saline|Inject 100 mg/kg of N-acetylcysteine or the equivalent amount of saline for 15 minutes before the skin incision, then continuously inject 40 mg/kg/day of N-acetylcysteine or the equivalent amount of saline during the next 24 hours.
16248187|NCT01021150|Drug|ombrabulin (AVE8062)|"Pharmaceutical form:injection solution
~Route of administration: intravenous infusion"
16248188|NCT01021150|Drug|cisplatin|"Pharmaceutical form: injection solution
~Route of administration: intravenous infusion"
16248320|NCT01019876|Drug|Cyclophosphamide 40|Cyclophosphamide/Fludarabine/ATG/TBI
16248321|NCT01019876|Drug|Cyclophosphamide 30|Cyclophosphamide /Fludarabine/TMG
16249243|NCT01013532|Drug|Probucol|Probucol 250mg bid
16248189|NCT01021111|Device|Activity Training with Feedback|The feedback system consisted of three small inertial measurement units affixed on the chest, thigh, and shank segment respectively. These units were connected to a computer that recorded the signal from the inertial sensors at 240 Hz during the jump task. Using custom software, the knee flexion angle, trunk lean, and coronal thigh angular velocity were calculated immediately after the subject completed the jump trial. A projector was used to display the results of the jump analysis. It took less than 10 minutes to place this system on a subject and less than five seconds to analyze a jump.
16248190|NCT01021072|Drug|MABp1|0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.
16248191|NCT01021059|Biological|rh IL-15|rh IL-15 daily for 12 days of 42 days cycle. Additional cycles may be given if patient is responding to therapy.
16248192|NCT01021046|Procedure|DALK using GCCT|Deep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue
16248193|NCT01021046|Procedure|DALK using FCT|Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue
16248194|NCT01021020|Drug|Colchicine|0.6mg tablet administered after a fast of at least 10 hours
16248195|NCT01021020|Drug|Colchicine|0.6mg tablet administered after a standardized high-fat, high-calorie breakfast
16248196|NCT01021020|Drug|Colchicine/Probenecid|0.5mg/500mg tablet administered after a fast of at least 10 hours
16248197|NCT01021007|Drug|Iodine|Rinse 2 times per day for 6 weeks
16248198|NCT01021007|Other|water|Use 2 times per day for 6 weeks
16248199|NCT01020994|Drug|LAS41003|Once daily, topically
16248200|NCT01020994|Drug|LAS189962|Once daily, topically
16248201|NCT01020994|Drug|LAS189961|Once daily, topically
16248202|NCT01020968|Biological|Ixmyelocel-T|CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.
16248203|NCT01020968|Other|Vehicle Control|will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.
16248204|NCT01020955|Drug|NutropinAq (GH) and Increlex (IGF-I)|NutropinAq (GH)(0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and Increlex (IGF-I) (15 µg/kg/d for 1 month, 30 µg/kg/d for 5 months)
16248205|NCT01020955|Drug|NutropinAq and placebo|NutropinAq (0.15 mg/d for 1 month, 0.3 mg/d for 5 months) and placebo for 6 months.
16248206|NCT01020942|Procedure|Electroacupuncture stimulation|According to the theory of traditional Chinese medicine, bilateral Neiguan (PC 6) acupoints were chosen and identified according to traditional anatomical localizations. Once insertion of original needles was made at the acupoints, the needle was stimulated electrically with the intensity of 2-6 mA and frequency of 2/30 Hz using the Electronic Acupuncture Treatment Instrument until the patient felt the so-called 'Teh Chi' sensation of heaviness, numbness and swelling. The pretreatment was individualized based on patients sex, age, weight and felt and given 1 time per day for 5 consecutive days before the heart valve replacement surgery．
16248207|NCT01020942|Procedure|No intervention|The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.
16248208|NCT01020929|Device|Blunt Coude|Type of needle tip
16248209|NCT01020929|Device|Quincke|Type of needle tip
16248210|NCT01020929|Device|Trucath|Type of needle tip
16248211|NCT01020916|Procedure|Target temperature 36°C|In hospital target temperature management to achieve a core body temperature of 36°C for 24 hours
16248212|NCT01020916|Procedure|Target Temperature 33°C|In hospital target temperature management to achieve a core body temperature of 33°C for 24 hours
16248213|NCT01020903|Procedure|Aprepitant|40 mg po pre-op
16248214|NCT01020903|Drug|Placebo|Orally, pre-op
16248215|NCT01020877|Drug|Metronidazole|Vaginal Gel, 0.75%
16248216|NCT01020877|Drug|Metronidazole|Vaginal Gel, 0.75%
16248217|NCT01020864|Drug|Cetuximab|Cetuximab 500 mg/m² i.v. day 1, every 2nd week
16248218|NCT01020864|Drug|Carboplatin|Carboplatin AUC = 3 i.v. day 1, every 21nd week
16248219|NCT01020864|Drug|Vinorelbine|Vinorelbine 25 mg/m² i.v. day 1, every 2nd week
16248220|NCT01020851|Behavioral|tailored intervention|6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
16248221|NCT01020851|Behavioral|attention placebo|6 monthly telephone-delivered sessions focusing on general health topics
16248222|NCT01020838|Drug|Florbetaben (BAY94-9172)|Single intravenous injection 1-5ml, 300 MBq (+/- 20%)
16248223|NCT01020825|Drug|ASCs|Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
16248224|NCT01020825|Drug|Fibrin glue|After curettage, the fistulous tract was sealed with fibrin glue.
16248225|NCT01020825|Drug|ASCs|Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
16248226|NCT01020812|Procedure|TACE|Standard of Care
16248227|NCT01020812|Procedure|SBRT|Standard of Care
16248228|NCT01020799|Drug|AZD7268|15 mg, oral, twice daily (BID)
16248229|NCT01020799|Drug|Escitalopram|20 mg, oral, once daily (QD)
16248230|NCT01020799|Drug|Placebo capsules|Placebo capsules to match AZD7268
16248231|NCT01020799|Drug|Placebo tablets|Placebo tablets to match encapsulated escitalopram
16248232|NCT01020786|Drug|Pemetrexed|"Induction Therapy: 500 milligrams per square meter (mg/m^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
~Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
16248233|NCT01020786|Drug|Carboplatin|Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
16248234|NCT01020773|Behavioral|spontaneous breathing trial|
16248235|NCT01020760|Behavioral|Face down posture|Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
16248236|NCT01020747|Drug|Avastin® (bevacizumab)|Bevacizumab injections (~7.5-12.5mg in 0.3 - 0.5 c.c.) into diseased vocal folds in conjunction with 532 nm pulsed-KTP laser photoangiolysis, administered every 6 ±1 weeks, for a total of 5 treatments. No patient will have an injection volume exceed 0.5 cc. for any single treatment. If initial results indicate a benefit, as described below, an extension of the active treatment period will be permitted up to a total treatment duration of 18 months.
16248764|NCT01016912|Drug|BMS-790052|Tablets, Oral, 10 mg, daily, 24-48 weeks
16248237|NCT01020747|Drug|Saline|A sham injection with saline (0.3-0.5 cc) has been administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection.
16248238|NCT01020734|Biological|anti-thymocyte globulin|
16248239|NCT01020734|Drug|busulfan|
16248240|NCT01020734|Drug|cyclophosphamide|
16248241|NCT01020734|Drug|cyclosporine|
16248242|NCT01020734|Drug|fludarabine phosphate|
16248243|NCT01020734|Drug|methotrexate|
16248244|NCT01020734|Procedure|allogeneic hematopoietic stem cell transplantation|
16248245|NCT01020643|Drug|controlled administration of propofol|comparison of propofol sedation
16248246|NCT01020630|Drug|Sunitinib|Sunitinib will be orally administered at 25 mg once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.
16248247|NCT01020630|Drug|Placebo|Placebo will be orally administered once daily (in the morning without regards to meals) for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks.
16248248|NCT01020617|Dietary Supplement|Ls-33|10~10 CFU/day
16248249|NCT01020591|Other|Osteopathic evaluation|evaluation of movement and tissue mobility
16248250|NCT01020591|Other|Osteopathic evaluation with treatment|osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
16248251|NCT01020578|Other|Plasma kinetic study|This study is done with the injection of an artificial lipid nanoemulsion doubly labeled with 14C-cholesteryl oleate and 3H-cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood samples collected in a pre established period of time in 24 hours.
16248252|NCT01020565|Drug|Entecavir|Tablet, P.O., 0.1 OR 0.5 mg, once daily, 52 weeks
16248253|NCT01020552|Other|Provision of PAC job aids and provider training on the use of the job aids|Facility-level intervention applied to all study facilities
16248254|NCT01020539|Drug|Fludarabine|Conditioning Regimen
16248255|NCT01020539|Drug|Busulfan|Conditioning Regimen
16248256|NCT01020539|Drug|GVHD Prophylaxis|Can be FK506 (Tacrolimus/Prograf®), mycophenolate mofetil ((MMF)/Cellcept®), or methotrexate (MTX, amethopterin)
16248257|NCT01020539|Drug|Gemtuzumab Ozogamicin|Dose Escalation
16248258|NCT01020539|Drug|Anti-Thymocyte Globulin|Unrelated Donors only
16248259|NCT01020539|Drug|Isotretinoin|JMML patients only
16248260|NCT01020526|Drug|pregabalin|Oral capsule 75-450 mg/day
16248261|NCT01020474|Drug|placebo|matching placebo capsules twice daily.
16248262|NCT01020474|Drug|pregabalin (Lyrica)|75-450mg/day pregabalin dose optimised at start of study
16248263|NCT01020461|Device|Accuvein|Accuvein will be used to facilitate venous blood sampling
16248264|NCT01020461|Device|Accuvein|Accuvein will be used to facilitate peripheral IV catheter placement
16248265|NCT01020448|Drug|Triptorelin (Decapeptyl®)|One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
16248266|NCT01020435|Other|Spinal Manipulation|The procedure in its broadest definition describes the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, (hence, the rate at which it is applied), as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted).
16248267|NCT01020435|Other|Sham Spinal Manipulation|The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same.
16248268|NCT01020422|Procedure|Reduction mammaplasty|Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
16248269|NCT01020409|Procedure|cardiac surgery with CPB use|cardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
16248270|NCT01020396|Drug|Metronidazole|Vaginal Gel, 0.75%
16248271|NCT01020396|Drug|Metronidazole|Vaginal Gel, 0.75%
16248272|NCT01020357|Drug|Caffeine citrate injection|"Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
~Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
~Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy."
16248273|NCT01020357|Drug|placebo|normal saline
16248274|NCT01020344|Procedure|Lung volume reduction surgery|Lung volume reduction surgery
16248275|NCT01020331|Drug|Memantine|
16248276|NCT01020305|Drug|Temsirolimus|"Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate"
16248277|NCT01020305|Drug|Casodex (bicalutamide)|Casodex (bicalutamide) 50 mg/day PO
16248278|NCT01020279|Drug|Celecoxib, Ketoprofen|"Ketoprofen in Transfersome® gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d.
~Celecoxib, 200 mg, one capsule b.i.d."
16248279|NCT01020279|Drug|Ketoprofen|Placebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Oral placebo, one capsule b.i.d
16248280|NCT01020266|Procedure|non electroacupuncture stimulation|The same procedure as electroacupuncture except stimulation
16248322|NCT01019863|Drug|oxaliplatin|oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles
16248413|NCT01019161|Drug|C14 AZD1152|radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion
16248281|NCT01020266|Procedure|Electroacupuncture pretreatment|According to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery．
16248282|NCT01020253|Drug|alendronate, alfacalcidol|Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
16248283|NCT01020240|Behavioral|Avolition|- avolition for cesarean discomforts
16248284|NCT01020240|Behavioral|Orientation|"avolition of cesarean discomfort
~physiotherapy orientation"
16248285|NCT01020240|Behavioral|Guide|"avolition of cesarean discomfort
~physiotherapy orientation
~guide orientation"
16248286|NCT01020227|Behavioral|Integrative Therapies Intervention|Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement
16248287|NCT01020214|Drug|Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg|
16248288|NCT01020214|Drug|Benicar HCT® Tablets 40 mg/25 mg|
16248289|NCT01020175|Procedure|Bone marrow transplantation|Patients received bone marrow transplantation
16248290|NCT01020175|Procedure|Peripheral blood stem cell transplantation|Patients received filgrastim-mobilized peripheral blood stem cell transplantation
16248291|NCT01020162|Drug|Amitryptiline, gabapentin|For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.
16248292|NCT01020162|Procedure|Resection of the ilioinguinal nerve|In general anaesthesia the nerve was identified and resected as central as possible
16248293|NCT01020149|Other|MR Imaging|MRI is used to evaluate nerve regeneration after traumatic transsection and nerve repair.
16248294|NCT01020136|Drug|AG-013736|single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
16248295|NCT01020136|Drug|AG-013736|single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
16248296|NCT01020123|Drug|AZD1656|Different doses of AZD1656 administered to 5 groups of patients
16248297|NCT01020123|Drug|Placebo|AZD1656 placebo and glipizide placebo administered to 1 group of patients
16248298|NCT01020123|Drug|Glipizide|Glipizide administered to 1 group of patients
16248299|NCT01020071|Procedure|pattern scanning laser iridotomy and iridoplasty|peripheral laser iridotomy and iridoplasty using pattern scanning laser technique
16248300|NCT01020058|Procedure|Mesh repair for primary inguinal hernia|Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
16248301|NCT01020032|Other|"Individual receptive music therapy by U sequence method"|During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60.
16248302|NCT01020019|Drug|Dronabinol|Dronabinol: 20 mg/TID
16248303|NCT01020019|Drug|Placebo|Placebo control
16248304|NCT01020019|Drug|Lofexidine|Lofex: .6 mg/ TID
16248305|NCT01020006|Drug|PCI-27483|"Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care.
~All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are >3.50,a reduced dosage will be calculated."
16248306|NCT01020006|Drug|Gemcitabine|
16248307|NCT01019993|Procedure|conventional OLV followed with IL-HFPPV|The patients' lungs were mechanically ventilated with intermittent positive pressure ventilation using fraction of inspired oxygen (FiO2) of 0.5 in air, tidal volume (VT) of 8 mL/kg, inspiratory to expiratory [I: E] ratio of 1:2.5, zero positive end-expiratory pressure (PEEP), respiratory rate (R.R) was adjusted to achieve an arterial carbon dioxide tension (PaCO2) 35-45 mm Hg and peak inspiratory pressures were limited to 35 cm H2O. After pleurotomy, OLV was initiated with the same ventilatory settings for the dependent lung. After 30 min, the non-dependent collapsed lung was ventilated using HFPPV mode (IL-HFPPV) with another identical ventilator, with an internal circuit of low compliance, using FiO2 of 0.5 in air, VT 3 mL/kg, I: E ratio <0.3 and R.R 60 breaths/min.
16248308|NCT01019980|Drug|Diclofenac potassium|Diclofenac potassium
16248309|NCT01019980|Drug|Acetaminophen|Acetaminophen
16248310|NCT01019941|Drug|CKD-810, Taxotere inj.|Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, CKD-810 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.
16248311|NCT01019941|Drug|CKD-810, Taxotere inj.|Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, Taxotere inj. 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention.
16248312|NCT01019928|Drug|AZD1386|95 mg, oral solution, single dose
16248313|NCT01019928|Drug|Placebo to AZD1386|Placebo, oral solution, single dose
16248314|NCT01019915|Device|CRT|Insertion of CRT in patients with left bundle branch block. Assessment of skeletal muscle and infalmmatory profile
16248315|NCT01019889|Drug|SCRT|4 capsules,three times daily, for 7days or within symptom disappearance
16248316|NCT01019889|Drug|YPS|4 capsules, three times daily, for 7days or within symptom disappearance
16248317|NCT01019889|Drug|Placebo|4 capsules, three times daily, for 7days or within symptom disappearance
16248318|NCT01019876|Drug|Fludarabine|Fludarabine/Busulfan/Alemtuzumab
16248319|NCT01019876|Drug|Cyclophosphamide|Cyclophosphamide/Fludarabine/TMG
16248323|NCT01019850|Drug|Vorinostat|Patients on study will receive vorinostat orally once daily on days 1 to 14 of treatment.This is a single course treatment. The study has a planned dose escalation schedule, the starting dose level is 180 mg/M2.The maximum absolute dose of vorinostat is 400 mg.
16248324|NCT01019850|Radiation|131- I Metaiodobenzylguanidine|Patients will receive 131-I MIBG on day 3 , one hour after vorinostat dosing.Patients will initially receive 8 mCi/kg 131-I MIBG with 180 mg/m2/dose vorinostat. The dose of 131-I MIBG will be escalated in subsequent cohorts to 15 mCi/kg and then to 18 mCi/kg.If the starting dose exceeds the maximum tolerated dose, patients will be treated with a lowering of vorinostat dose initially (150 mg/m2/day . Dose level -1). If this combination still exceeds the maximum tolerated dose, then a dose level using reduced dose 131-I MIBG will be studied (6 mCi/kg. Dose level -2).
16248325|NCT01019850|Procedure|Peripheral Blood Stem Cell Infusion|Stem cell infusion is planned for 2 weeks after MIBG infusion (day 17). However, stem cells may be infused on day 18 or day 19 to avoid weekend or holiday stem cell infusions.The dose for Purged PBSC is a minimum of 2 x 106 viable CD34+ cells/kg and for Unpurged PBSC: a minimum of 2 x 106 viable CD34+ cells/kg must be available. Stem cells must be infused over 15-30 minutes and within 1.5 hours of thawing.Stem cells will be infused following institutional guidelines for prophylaxis of hypersensitivity reactions and monitoring.
16248326|NCT01019850|Drug|Filgrastim|All patients will receive filgrastim following hematopoietic stem cell infusion according to institutional guidelines (section 4.2.3 of protocol).
16248327|NCT01019837|Biological|Focetria (Monovalent MF59-Adjuvanted vaccine)|Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
16248328|NCT01019824|Drug|Ralfinamide|Ralfinamide Oral Tablets, 160 or 320 mg per day
16248329|NCT01019811|Procedure|The innervated sensory cross-finger flap|The innervated sensory cross-finger flap is a modified method for repair fingertip degloving injury
16248330|NCT01019798|Drug|sunitinib, docetaxel, cisplatin|"Sunitinib given 10 days within 14 days of each cycle。
~Sunitinib 25 mg/day with adjust dosage according to patient's condition, but should return to 25 mg when feasible or should withdraw from this study.
~Docetaxel 40-50 mg/m2, cisplatin 50 mg/m2 every 2 weeks.
~Overall 12 cycles (24 weeks)"
16248331|NCT01019785|Dietary Supplement|Ergocalciferol|100 000 U drops is given once
16248332|NCT01019785|Dietary Supplement|Ergocalciferol|500 U drops given once
16248333|NCT01019772|Biological|LBVH0101 (Hib vaccine)|
16248334|NCT01019772|Biological|Hiberix™ Vaccine|
16248335|NCT01019759|Procedure|pulmonary vein isolation|The off-pump beating heart ablation procedure is performed. Using a Microwave (MW) energy ablation tool (Microwave generator by Guidant), epicardial ablation line isolating the pulmonary veins are applied during open heart surgery
16248336|NCT01019746|Drug|propofol|propofol administration
16248337|NCT01019733|Procedure|Intrathecal Autologous Stem Cells|Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 5 times, harvest bone marrow and infused 8 to 10 mL of stem cells (CD34+) by intrathecal via.
16248338|NCT01019707|Drug|Atomoxetine, then Placebo|As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.
16248339|NCT01019707|Drug|Placebo, then Atomoxetine|As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.
16248340|NCT01019694|Drug|Combivent CFC-MDI|36/206 mcg Four times a day (QID)
16248341|NCT01019694|Drug|Combivent Respimat 20/100 mcg|Open label randomized parallel
16248342|NCT01019694|Drug|Atrovent HFA 42 mcg + Albuterol HFA 200 mcg|Open label randomized parallel
16248343|NCT01019681|Biological|Cord blood stem cell injection|"The cord blood stem cells will be simply injected intramuscularly in the leg. 30 minutes prior to stem cell injection the patients will receive Vancomycin 1 gram IVPB x1 as a prophylactic measure. Patients will also receive Ativan 0.5 to 1 mg PO x 1 and Dilaudid 0.5 to 1 mg IV x1 to alleviate the discomfort of the procedure.
~Cells will be injected by means of a 22 gauge sterile spinal needle after topical anesthesia of the injection site. The concentration will be at least 2 x 107 total nucleated cells per ml in phosphate buffered saline (PBS) with 5% human serum albumin (Baxter, Deerfield Illinois)."
16248344|NCT01019668|Drug|Verteporfin PDT, half-dose|half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
16248345|NCT01019668|Drug|verteporfin PDT, half-fluence|half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
16248346|NCT01019655|Drug|Nadroparin calcium|nadroparin calcium (fraxiparin®) 0.3 mL daily during pregnancy and six weeks post partum
16248347|NCT01019642|Drug|cholecalciferol|4,000 IU per day during 6 months. Capsule form.
16248348|NCT01019642|Drug|placebo|no active principles given.
16248349|NCT01019616|Drug|paclitaxel/anthracycline|standard chemotherapy regimen(containing paclitaxel or anthracycline) different from primary chemotherapy(containing anthracycline or paclitaxel)
16248350|NCT01019603|Drug|Tazarotene|Topical Tazarotene foam applied daily for 22 days.
16248351|NCT01019603|Drug|Tazaroc Gel|Topical tazarotene gel applied daily for 22 days.
16248352|NCT01019590|Drug|Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg|
16248353|NCT01019590|Drug|Benicar HCT ® Tablets 40 mg/25 mg|
16248354|NCT01019577|Drug|Ixabepilone|Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles
16248355|NCT01019564|Device|Complete Easy Rub Formula MPS|Multi-purpose solution
16248356|NCT01019564|Device|Aquify MPS|Multi-purpose solution
16248357|NCT01019551|Drug|ART Intensification|Current ART regimen plus raltegravir and maraviroc Raltegravir : 400 mg PO BID for 56 weeks Maraviroc : 150, 300 or 600 mg PO BID depending on concomitant ART treatment, for 56 weeks
16248358|NCT01019551|Biological|Immunomodulation|Starting at Week 8, 1 cycle of 3 injections (1 per week) of recombinant human Interleukin-7 (r-hIL-7 / CYT107) at a 20 µg/kg dose.
16248414|NCT01019135|Behavioral|Cardiac Rehabilitation|comparison of multiple cardiac rehabilitation program models
16249244|NCT01013532|Drug|Aspirin|Aspirin 100mg qd
16248359|NCT01019538|Other|Pre-flight test with supplemental oxygen|The Hypoxia-altitude simulation test, which is established in clinical practice, is compared to the gold standard of hypobaric chamber while giving supplemental gaseous oxygen without and with oxygen conserving device, and with oxygen concentrator.
16248360|NCT01019499|Other|berry products|"effects of berry consumption on cardiovascular indicators
~two portions daily"
16248361|NCT01019499|Other|control products|two portions daily
16248362|NCT01019486|Drug|Regadenoson myocardial perfusion imaging|Myocardial perfusion imaging at rest and following 400mcg Regadenoson IV bolus pharmacologic stress with 30 mCi of Tc-99m sestamibi injected at both but the studies performed 48 hours apart.
16248363|NCT01019486|Drug|Regadenoson MRI myocardial blood flow|CMR assessment of stress myocardial perfusion and blood flow after 400 mcg Regadenoson pharmacologic using gadolinium contrast (gadoteridol) 0.05mmole/kg at stress and rest.
16248364|NCT01019473|Drug|AFQ056|
16248365|NCT01019473|Drug|Placebo|
16248366|NCT01019460|Procedure|Magnetic resonance imaging, computed tomography scanning and capsule endoscopy|All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT.
16248367|NCT01019447|Other|Vicryl Plus|Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)
16248368|NCT01019447|Other|Vicryl|Polyglactin 910 antimicrobial sutures (Vicryl)
16248369|NCT01019434|Drug|temozolomide|TMZ will be given at 75 mg/m2 daily for the whole period of RT including weekends as registered.
16248370|NCT01019434|Drug|temsirolimus|CCI-779 will be given i.v. once every week at 25 mg. Each treatment should be preceded by supportive medication with a histamine H2-receptor antagonist. A first dose of CCI-779, being 25 mg, will be given on day -7 from RT start.
16248371|NCT01019421|Drug|Lu AE58054|Add-on treatment to donepezil
16248372|NCT01019421|Drug|Placebo|Add-on treatment to donepezil
16248373|NCT01019408|Drug|Chloroquine|Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
16248374|NCT01019395|Drug|Daptomycin|"Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion;
~Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion;
~Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion."
16248375|NCT01019382|Drug|Lipidem fish oil infusion + Gemcitabine chemotherapy|500mls intravenous infusion once a week of lipidem in addition to standard starting dose of gemcitabine (1000mg/m2) Dose can be reduced if poorly tolerated
16248376|NCT01019369|Drug|Medroxyprogesterone 17-Acetate|Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
16248377|NCT01019369|Drug|Medroxyprogesterone 17-Acetate|Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
16248378|NCT01019356|Drug|Rosiglitazone|4 mg twice daily for 8 weeks orally
16248379|NCT01019356|Drug|Acarbose|100 mg three times daily for 8 weeks orally
16248380|NCT01019343|Procedure|Transcranial Direct Current Stimulation(tDCS)|Transcranial direct current stimulation involves the application of weak direct currents, delivered between two surface electrodes, placed over the scalp.
16248381|NCT01019343|Device|Eye-tracking Device|The purpose of this device is to assess eye movement. Participants may sit down in front of a computer screen or a real-world environment, stand on a treadmill, or lie down in an MRI scanner. Small infrared cameras attached to the cap or glasses will be positioned in front of their eyes. Eye tracking might be performed alone, or in conjunction with EEG, EMG, fMRI or treadmill. The eye- tracking device is FDA approved and commercially available.
16248382|NCT01019343|Device|Pulsed vibrator|This device would be used in experiments to see if gait can be improved and, if so, what parameters of stimulation are optimal.
16248383|NCT01019343|Other|Gait Trainer Treadmill (GTT)|The Gait Trainer is a specialized rehabilitation treadmill, which operates in both the forward and backwards mode allowing subjects to both train and undergo performance tasks in a relatively safe and expedient manner. The GTT is equipped with a mounted deck with built in sensors which monitors and records subjects gait speed, step length, right to left time distribution, and symmetry in real time in both forward and reverse modes.
16248384|NCT01019343|Other|Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scalesMMSE and MOCA|Scales of motor function, cognitive function and psychiatric function are valuable supplements to clinical assessments of patients, giving quantitative information concerning these different aspects of brain function. Selected scales would be used only when potentially useful in a sub-study where such quantitative information would be correlated with a physiological or imaging result.
16248385|NCT01019343|Device|iMobility|This test uses the iMobility system. iMobility Device is a small device designed to measure movement through sensors (test monitors) worn by a patient via Velcro straps around an ankle or wrist or worn as a pendant around the neck to lie over the sternum. The device is a nonsignificant risk device.The iMobility Device has been used before, in the same format with a similar paradigm, in previous NIH studies.
16248386|NCT01019343|Device|QMAT|The purpose of this study is to assess the ability of the QMAT (quantitative motor assessment tool) to assess slowness of movement associated with Parkinson Disease. The QMAT device is FDA approved and has been used before, in the same format with a similar paradigm, in previous NIH studies.
16248387|NCT01019343|Diagnostic Test|Treadmill Test|Subjects will be fitted in a weight support harness for safety. Sensors will be placed on the subject s shoes and harness. The sensors (VICON system) will be used to record their stride length, position and velocity as they walk on a treadmill. This system is a motion- tracking system that is designed to measure various aspects of a person s gait.
16248388|NCT01019343|Device|Arm Intellistretch Device|The purpose of the Arm Intellistretch device is to objectively quantify wrist tone. It is used for rehabilitation applications in hospitals and office settings. Currently, rigidity is evaluated clinically using a subjective scale, zero to four and is part of the UPDRS. The Arm Intellistretch device is manufactured by Rehabtek, Inc., is FDA approved, and has been determined to be a non- significant risk device by the CNS IRB.
16248411|NCT01019174|Drug|Cyclophosphamide|comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous
16248412|NCT01019161|Drug|AZD1152|100mg Lyophile, 5mL Diluent IV infusion
16248389|NCT01019343|Procedure|Transcranial Sonography (TCS)|Transcranial sonography will be conducted by a physician in the Clinical Center using the Acuson Antares ultrasound machine. This techniques uses ultrasound signals to image the brain. It entails having the subject sit in a chair or lay in a bed while the sonographer places a lubricated 2- inch ultrasound probe over the skin of the temporal area just above the patient s ear. Ultrasound images are then recorded. The procedure is not invasive and will last about 45 minutes.
16248390|NCT01019343|Other|Behavioral tasks|To assess the changes in cerebral physiology in the brain, subjects will be presented sensory stimuli (e.g., primary visual stimulation with flashing lights or checkerboard, auditory with tone or speech, or olfactory stimuli), or will be asked to perform non- exercise motor tasks (e.g., tapping of fingers, squeezing ball, moving joystick), to perform cognitive tasks such as a working memory task (e.g., n-back with or without catch rules, word finding), or to just rest or sleep.
16248391|NCT01019343|Procedure|TMS single/paired pulse|For MEP acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles (see subsection EMG 7.1.3.1 for the details of the procedure).
16248392|NCT01019343|Procedure|MEG|MEG recordings will be performed together with experienced personnel in the NIMH MEG lab in the NMR center in Building 10. For these recording sessions, subjects will sit in a chair or lay down with a helmet placed over the head. The helmet used for MEG does not require the application of conductive gel. Scan times vary from 20 minutes to 2 hours.
16248393|NCT01019343|Procedure|EEG|EEGs will be recorded by, or together with, experienced personnel in the HMCS EEG lab in Building 10, or in the NMR center.
16248394|NCT01019343|Procedure|MRI techniques|MRI sub-studies will be conducted on 3.0 T or 7T units in the NMR Research Center. All volunteers will comply with the yearly requirement of a standard clinical diagnostic MRI scan of the head performed at 3.0T, to be submitted to the Diagnostic Radiology Department of the Clinical Center for interpretation. If the subject does not have a clinical scan performed within 12 month of the exam, a standard clinical MRI will be performed and reviewed before the research MR. The standard examination takes approximately 15 minutes to complete; after that, the research MR scans will be performed. Standard clinical MRI of the head will be repeated on an annual basis and read by the Diagnostic Radiology Department of the Clinical Center.
16248395|NCT01019343|Procedure|Peripheral Nerve Stimulation|Constant-current, 0.1 to 0.5 ms square- wave single pulses of electrical stimulation will be delivered through standard bar electrodes to nerves of the upper limb or of the lower limb. To study somatosensory evoked potentials, for example, the stimulus intensity will be set at just above the motor threshold for evoking a slight limb movement. Location of the electrical stimulation will depend on the specific objective of the sub-study. Peripheral nerve stimulation might be delivered during other types of experiments as well.
16248396|NCT01019343|Procedure|EMG|EMG measures the electrical activity of muscles. For our research purposes, only surface EMG will be used to measure the effects of central and peripheral nervous system stimulation. For surface EMG, electrodes will be coated with a conductive gel and taped to the skin. For motor evoked potential (MEP) acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles.
16248397|NCT01019343|Procedure|Trancutaneous spinal direct current stimulation (tsDCS)|Direct current (DC) stimulation is a non invasive tool used to promote plasticity of the central nervous system. Recently, DC stimulation has been applied to the human spinal cord, and known as transcutaneous spinal direct current stimulation (tsDCS).
16248398|NCT01019330|Other|Allen's test|The Allen's test checks to make sure that radial and ulnar arteries that supply blood to the hand are not blocked. A pulse oximeter is placed on the index finger of the hand. The subject is asked to make a fist for 10 seconds.At this time, pressure is applied over the ulnar and radial arteries as to occlude (block) both of them. The pulse oximeter reading will begin to fall. Radial arterial pressure is then released. If the artery is patent (working), the pulse oximeter reading will begin to rise.
16248399|NCT01019330|Other|Distal pulses|Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.
16248400|NCT01019317|Drug|Cytarabine|0.5 grams/m^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3).
16248401|NCT01019317|Drug|Fludarabine|15 mg/m^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3).
16248402|NCT01019291|Other|Formaldehyde and NO2 (Exposure to indoor pollutants)|Exposure to indoor pollutants (Formaldehyde and NO2) in a randomized way, followed by bronchial challenge test with house dust mite extract.
16248403|NCT01019291|Other|Placebo (Exposure to indoor pollutants)|Exposure to indoor pollutants (placebo) in a randomized way, followed by bronchial challenge test with house dust mite extract.
16248404|NCT01019265|Drug|Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg|Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
16248405|NCT01019252|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
16248406|NCT01019239|Procedure|Laparoscopic Washout|Pneumoperitoneum will be established via a blunt entry 12mm umbilical port. Two 5mm ports will be placed in the suprapubic and right lower quadrants. The peritoneal cavity will be thoroughly examined and stage classified according to Hinchey. Peritoneal lavage will be performed in all four quadrants using at least 4 litres of warmed saline until the drainage is clear. Two non-suction Penrose drains will be placed.
16248407|NCT01019239|Procedure|Hartmann's Procedure/ Primary Resection and Anastomosis|24 Pneumoperitoneum will be established via a blunt entry 12mm umbilical port. Two 5mm ports will be placed in the suprapubic and right lower quadrants to facilitate triangulation of instruments during manipulation and lavage. The peritoneal cavity will be thoroughly examined and stage classified according to Hinchey. . In the absence of faeculant peritonitis, patients will be randomised to undergo Hartmann's procedure or primary resection and anastomosis (depending on standard practice in the individual unit).
16248408|NCT01019213|Other|Septal pacing|Septal lead activated
16248409|NCT01019213|Other|His lead activated|His lead will be activated 80 ms before septal lead
16248410|NCT01019174|Drug|Cyclophosphamide|comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous
16248415|NCT01019109|Device|Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.|PASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.
16248416|NCT01019083|Drug|Placebo|Placebo will be given according to randomization list
16248417|NCT01019083|Drug|Placebo|Placebo will be given according to randomization list
16248418|NCT01019083|Other|Control|Control will be selected from the Arsenic non contaminated Area
16248419|NCT01019083|Drug|Zinc Sulphate|Zinc Sulphate will be given according to randomization list
16248420|NCT01019083|Drug|Albendazole and Secnidazole|Albendazole and Secnidazole will be given according to randomization list
16248421|NCT01019083|Other|Arsenic|Participant will be selected from the Arsenic Contaminated Area
16248422|NCT01019070|Drug|BMS-650032|Capsules, Oral, 200 mg, BID, 7 Days
16248423|NCT01019057|Procedure|ILIF|Interlaminar lumbar instrumented fusion (ILIF™) is a compound surgical solution to spinal stenosis, combining direct neural decompression with an allograft interspinous spacer (ExtenSure® H2) to maintain the segmental distraction, and a spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion.
16248424|NCT01019044|Procedure|Rectal mucosa biopsy|Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction
16248427|NCT01019005|Device|Catheter|Catheter inserted into either perineural tibial nerve or wound
16248428|NCT01018992|Drug|GSK561679|GSK561679, oral administration, 350mg/day, 6 week administration
16248429|NCT01018992|Drug|Placebo|Matching placebo, oral administration, 1 pill/day for 6 weeks
16248430|NCT01018979|Drug|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
16248431|NCT01018979|Drug|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
16248432|NCT01018966|Drug|Ixabepilone|Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
16248433|NCT01018953|Drug|BIM 23A760|BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.
16248434|NCT01018927|Device|Administering three additional MRI images|Three additional MRI images to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration
16248435|NCT01018914|Drug|Prograf|oral
16248436|NCT01018914|Drug|Advagraf|oral
16248437|NCT01018914|Drug|Myfortic|oral
16248438|NCT01018888|Device|Auro KPro (Keratoprosthesis)|Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
16248439|NCT01018862|Drug|Azelastine hydrochloride nasal spray 0.15%|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
16248440|NCT01018862|Drug|Azelastine hydrochloride nasal spray 0.10%|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
16248441|NCT01018862|Drug|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
16248442|NCT01018849|Dietary Supplement|Cholecalciferol|cholecalciferol 150,000 IU by mouth every 2 months for 1 year
16248443|NCT01018849|Dietary Supplement|Placebo|placebo by mouth every 2 months for 1 year
16248444|NCT01018836|Drug|riluzole|The first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians.
16248445|NCT01018836|Radiation|whole-brain radiation therapy|Standard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1.
16248446|NCT01018823|Drug|Ertugliflozin|Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
16248447|NCT01018823|Drug|Placebo to Ertugliflozin|Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
16248448|NCT01018810|Drug|LY2525623 Intravenous|administered intravenously at randomization and every 2 weeks for 6 weeks
16248449|NCT01018810|Drug|LY2525623 Subcutaneous|administered subcutaneously at randomization and every 2 weeks for 6 weeks
16248450|NCT01018810|Drug|Placebo Intravenous|administered intravenously at randomization and every 2 weeks for 6 weeks
16248451|NCT01018810|Drug|Placebo Subcutaneous|administered subcutaneously at randomization and every 2 weeks for 6 weeks
16248452|NCT01018797|Procedure|INTRASTROMAL CORNEAL RING SEGMENT|Corneal tunnels were created by means of mechanical dissection in all eyes. Intrastromal corneal ring segments implantation was indicated because of the existence of reduced best spectacle-corrected visual acuity (BSCVA) or contact lens intolerance.
16248453|NCT01018784|Drug|MORAb-009|MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.
16248454|NCT01018771|Procedure|Actifuse ABX|bone graft to be used in posterolateral instrumented lumbar fusion
16248455|NCT01018771|Procedure|INFUSE, plus Mastergraft granules|bone graft to be used in posterolateral instrumented lumbar fusion
16248456|NCT01018758|Drug|Palonosetron|Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.
16248457|NCT01018745|Drug|BMS-907351 (XL184)|Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent
16248458|NCT01018732|Biological|Novartis Meningococcal (MenACWY-CRM) vaccine|All subjects will have blood draws at Day 1, Day 8, and Day 29.
16248459|NCT01018719|Device|MDCT, ECG, Echocardiography|Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.
16248460|NCT01018693|Drug|VAK694; Alutard Avanz SQ|
16248461|NCT01018693|Drug|VAK694 placebo infusion; Alutard Avanz SQ|
16248462|NCT01018693|Drug|VAK694 placebo infusion; Saline|
16248463|NCT01018680|Drug|Duloxetine|30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks.
16248464|NCT01018680|Drug|Placebo|Taken by mouth, once daily for 10 weeks
16248465|NCT01018654|Behavioral|Standard Cognitive Behavioral Treatment|Standard CBT for Substance Abuse
16248466|NCT01018654|Behavioral|Culturally Adapted Cognitive-Behavioral Treatment|Culturally Adapted CBT for Substance Abuse
16248467|NCT01020708|Drug|mesalamine|4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily
16248468|NCT01020708|Drug|ALTH12-1:4|ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine
16248469|NCT01020708|Drug|ALTH12-2:4|ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine
16248470|NCT01020487|Drug|Paricalcitol|Paricalcitol capsules taken with water.
16248471|NCT01020487|Drug|Placebo|Placebo capsules taken with water
16248472|NCT01020383|Drug|ALX-0081|4 i.v. bolus injections, once every 6 hours; first dose of 6 mg, three subsequent doses of 4 mg
16248473|NCT01020383|Drug|ReoPro®|0.25 mg/kg i.v. bolus injection followed by continuous i.v. infusion of 0.125 µg/kg/min (to a max. of 10 µg/min) for 12 hours
16248474|NCT01020292|Drug|Nelfinavir|
16248475|NCT01020097|Drug|fluorine F18 EF5|Given IV
16248476|NCT01020097|Procedure|immunohistochemistry staining method|Correlative study
16248477|NCT01020097|Procedure|biopsy|Correlative study
16248478|NCT01020097|Procedure|Positron Emission tomography|Undergo scan
16248479|NCT01019512|Other|questionnaire administration|Ancillary studies
16248480|NCT01019512|Other|lymphedema management|
16248481|NCT01019278|Radiation|proton beam radiation therapy|Undergo external proton beam radiation
16248482|NCT01019278|Radiation|radiation therapy treatment planning/simulation|
16248483|NCT01019278|Drug|cisplatin|Given IV
16248484|NCT01019187|Procedure|Quality-of-Life Assessment|Ancillary Studies
16248485|NCT01019187|Other|Questionnaire Administration|Ancillary Studies
16248486|NCT01019187|Other|Placebo|Given orally
16248487|NCT01019187|Procedure|Fatigue Assessment and Management|
16248488|NCT01019187|Procedure|Sleep Disorder Therapy|
16248489|NCT01019187|Drug|Armodafinil|Given orally
16248490|NCT01019187|Procedure|Quality-of-life assessment|Ancillary studies
16248491|NCT01019187|Other|Questionnaire Administration|Ancillary Studies
16248492|NCT01019187|Procedure|Fatigue Assessment and Management|
16248493|NCT01019187|Procedure|Management of Therapy|
16248494|NCT01019187|Procedure|Sleep disorder therapy|
16248495|NCT01019187|Procedure|cognitive assessment|
16248496|NCT01019187|Procedure|Quality of Life assessment|Ancillary Studies
16248497|NCT01019187|Other|Questionnaire Administration|Ancillary studies
16248498|NCT01019187|Other|Placebo|Given orally
16248499|NCT01019187|Procedure|Fatigue assessment and management|
16248500|NCT01019187|Procedure|Management of therapy and complications|
16248501|NCT01019187|Procedure|Sleep disorder therapy|
16248502|NCT01019187|Drug|Armodafinil|Given orally
16248503|NCT01019187|Procedure|Cognitive Assessment|
16248504|NCT01019187|Procedure|Quality of Life Assessment|Quality of Life Assessment
16248505|NCT01019187|Other|Questionnaire Administration|Ancillary Studies
16248506|NCT01019187|Procedure|Fatifue assessment and management|
16248507|NCT01019122|Radiation|Dexa Scan|Dexa scan of left and right distal femur, then lumbar spine, and whole body when possible
16248508|NCT01018901|Other|Survey Administration|Patients complete survey
16248509|NCT01018875|Drug|ABT-288|Subjects will take 4 capsules once daily for 12 weeks.
16248510|NCT01018875|Drug|donepezil|Subjects will take 4 capsules once daily for 12 weeks.
16248511|NCT01018875|Drug|placebo|Subjects will take 4 capsules once daily for 12 weeks.
16248512|NCT01018641|Biological|SA3Ag vaccine|"In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
~In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1."
16248513|NCT01018641|Procedure|Blood draw|Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
16248514|NCT01018641|Procedure|Colonization swab samples|Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
16248515|NCT01018641|Biological|SA3Ag followed by Placebo|"In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
~In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo."
16248516|NCT01018641|Procedure|Blood draw|Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
16248517|NCT01018641|Procedure|Colonization swab samples|Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
16248518|NCT01018641|Biological|Placebo|In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.
16248519|NCT01018641|Procedure|Blood draw|Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
16248520|NCT01018641|Procedure|Colonization swab samples|Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
16248763|NCT01016925|Procedure|tunnelized perineural catheter|the catheter will be tunneled 2-3 cm subcutaneously.
16248521|NCT01018641|Biological|SA3Ag with no booster in stage 2|"In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
~Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
~In stage 2 the subject will receive no vaccine."
16248522|NCT01018641|Procedure|Blood draw|Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
16248523|NCT01018641|Procedure|Colonization swab samples|Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
16248524|NCT01018641|Procedure|Placebo with no booster in stage 2|"In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.
~In stage 2 the subject will receive no vaccine."
16248525|NCT01018641|Procedure|Blood draw|Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
16248526|NCT01018641|Procedure|Colonization swab samples|Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
16248527|NCT01018628|Drug|SRT2379|SRT2379 will be supplied as hard gelatin capsules, with each containing 25 mg or 250 mg of SRT2379 free base equivalent (31 or 310 mg of SRT2379 monosuccinate) without any additive.
16248528|NCT01018628|Drug|Placebo|For placebo product, the SRT2379 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 200) to match the SRT2379 investigational product.
16248529|NCT01018615|Drug|silymarin|capsules, 700 mg, twice daily, 12 days
16248530|NCT01018615|Dietary Supplement|green tea extract (EGCG)|capsules, 196.5 mg, twice daily, 12 days
16248531|NCT01018602|Drug|vildagliptin|100 mg per day over 24 months
16248532|NCT01018602|Drug|inactive pill|1 pill per day over 24 months
16248533|NCT01018589|Other|Cicatrix cream|"We will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations.
~To the patient will be explained the technique of the application."
16248534|NCT01018576|Other|Delayed cord clamping|Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.
16248535|NCT01018563|Drug|MORAb-003|Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.
16248536|NCT01018550|Drug|AMG 853|AMG 853 5 mg (BID)
16248537|NCT01018550|Drug|AMG 853|AMG 853 200 mg (QD)
16248538|NCT01018550|Drug|AMG 853|AMG 853 25 mg (BID)
16248539|NCT01018550|Drug|AMG 853|AMG 853 100 mg (BID)
16248540|NCT01018550|Drug|Placebo|Placebo
16248541|NCT01018524|Procedure|abdominal wall reconstruction|suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
16248542|NCT01018511|Drug|Placebo tamsulosin hydrochloride OCAS 0.4 mg|tablet
16248543|NCT01018511|Drug|Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg|tablet
16248544|NCT01018511|Drug|Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg|tablet
16248545|NCT01018511|Drug|tamsulosin hydrochloride OCAS 0.4 mg|tablet
16248546|NCT01018511|Drug|tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)|tablet
16248547|NCT01018511|Drug|tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)|tablet
16248548|NCT01018498|Behavioral|Restricted FODMAPs diet|Restricted fermentable substrate diet
16248549|NCT01018485|Drug|Botulinum Toxin Type A|Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
16248550|NCT01018472|Dietary Supplement|Bifidobacterium infantis|1 billion organisms twice daily either through a feeding tube or by mouth for 4 months
16248551|NCT01018472|Other|Placebo|A dilute preparation of pregestimil formula (similar in appearance to the probiotic product)
16248552|NCT01018459|Biological|Ad35.CS.01 Circumsporozoite Malaria Vaccine|Ad35.CS.01 appears clear to slightly opalescent with no visible particles. Each 0.75 mL dose of the assigned dosage will be administered via intramuscular injection into the deltoid muscle. Dosages: 10^9 viral particles (vp)/mL, 10^10 vp/mL, 5 x 10^10 vp/mL, and 10^11 vp/mL.
16248553|NCT01018459|Drug|Placebo|Normal saline placebo control delivered via intramuscular injection into the deltoid muscle.
16248554|NCT01018446|Drug|Busulfan|First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
16248555|NCT01018433|Behavioral|T-SIB|Treatment for self-injurious behaviors; study psychotherapy
16248556|NCT01018433|Other|Treatment as usual|Can include other psychotherapy and pharmacotherapy
16248557|NCT01018420|Drug|Colchicine|two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses
16248558|NCT01018420|Drug|Moxifloxacin|400 mg capsule at the 6 hour point
16248559|NCT01018407|Behavioral|Discrete Trial Training|"UCLA model, developed by Lovaas and colleagues (Smith, Groen & Wynn, 2000). Two 30-minute sessions daily (5 hours/week) of 1:1 intervention focusing on imitation, match-to-sample, receptive and expressive language. Using operant conditioning, the therapist works individually with a child in a distraction-free setting and administers approximately 10 trials in a sitting, with breaks between sittings.
~During months 5 and 6, we will provide parents with training in an apprenticeship format one day per week for an hour per day. The clinician will demonstrate a DTT instructional program, then the parent will take a turn implementing it. The clinician and parent will give each other feedback on their implementation of the program."
16248605|NCT01018121|Behavioral|LAUNCH|A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.
16248560|NCT01018407|Behavioral|Interpersonal Developmental Approach|"Focus on teaching joint attention and symbolic play developmentally via floor play milieu teaching approach. Principles applied include following the child's lead and interest in activities, talking about what the child is doing, repeating back what the child says, expanding on what child says, giving corrective feedback, sitting close to the child and making eye-contact, and making environmental adjustments to engage the child (Kasari et al., 2006).
~Parents will be incorporated into the treatment to encourage joint engagement with their child and to focus specifically on joint attention and play skills in their interactions. Each home session will last one hour (once a week) during month 5 and 6 and will involve therapist modeling, and coaching of parent in child-directed activities."
16248561|NCT01018394|Drug|nicotine lozenges|4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
16248562|NCT01018394|Drug|tobacco-free snuff|Tobacco-free snuff used ad lib for a maximum of 12 weeks
16248563|NCT01018381|Procedure|PEIT|"For patients with HCC: Ethanol (99.5%) 3-15 ml/treatment(mean 8ml/treatment) , 2 times/week (mean 6 treatment/patient). For patients with a tumor size under 5 cm in diameter, we applied the formula of M. Ebara: V = 4/3∏ (r+0.5)3 (V: total Ethanol volume, r: radius of tumor).
~Precise treatment was dependent on tumor size, outcomes after first PEIT treatment and time to recurrence of disease."
16248564|NCT01018381|Procedure|TOCE|For patients with HCC: Adriamycine was mixed with lipiodol, Adriamycine 20-60mg/treatment (mean 40mg/treatment),lipiodol 5-20ml/treatment(mean 12ml/treatment), 1-2 months between treatments, 2-5 treatments/patient (mean 3 times/patient), which depended on tumor size, outcomes after first TOCE and time to recurrence of disease.
16248565|NCT01018381|Procedure|TOCE plus PEIT|A combination of transarterial oily chemoembolization and pericutaneous ethanol injection therapy are given for patients with HCC.
16248566|NCT01018381|Procedure|TOCE plus RFA|For patients with HCC: A combination of transarterial oily chemoembolization plus radiofrequency ablation is given. For RFA: On mission 60w/s , 5minutes/circle, 2-4 circles/treatment, 1-2 treatments/week (tumor size under 2cm: 1 treatment; 2-4 cm: 2-3 treatments,over 4 cm: 3-5 treatments)
16248567|NCT01018381|Dietary Supplement|MGN-3|For patients with HCC or hepatitis B, arabinoxylan rice bran food supplement is given. 1 gram per day, every day, for a duration of 12 months. For the MGN-3 group, the interventional therapy was given with MGN-3 simultaneously.
16248568|NCT01018381|Drug|Entecavir|For patients with hepatitis B viral infection, a dose of 0.5mg/day, every day, was given for a duration of 24 months.
16248569|NCT01018368|Drug|VX-770|In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.
16248570|NCT01018368|Drug|Rifampin|In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10
16248571|NCT01018355|Device|Percutaneous device closure of patent foramen ovale|Percutaneous device closure of patent foramen ovale
16248572|NCT01018342|Drug|Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg|
16248573|NCT01018342|Drug|Macrobid® Capsules 100 mg|
16248574|NCT01018329|Procedure|Magnetic Resonance Imaging|
16248575|NCT01018329|Procedure|Diffusion Tensor Imaging|
16248576|NCT01018329|Procedure|Magnetic Resonance Spectroscopic Imaging|
16248577|NCT01018329|Procedure|Dynamic Contract-Enhanced magnetic resonance imaging|
16248578|NCT01018329|Procedure|Diffusion-weighted magnetic resonance imaging|
16248579|NCT01018303|Dietary Supplement|AquADEK|Two AquADEK softgel vitamins on a daily basis x 12 weeks
16248580|NCT01018277|Other|Mobilization (walking)|25 meters twice
16248581|NCT01018264|Drug|solifenacin succinate (VESIcare)|up to 10mg every day orally
16248582|NCT01018264|Drug|placebo|placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
16248583|NCT01018251|Other|3'-deoxy-3'-[18F]fluorothymidine|Given IV
16248584|NCT01018251|Procedure|Positron Emission Tomography/computed tomography|
16248585|NCT01018251|Radiation|FLT-PET/CT|
16248586|NCT01018238|Drug|NNC 0151-0000-0000|Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
16248587|NCT01018238|Drug|placebo|Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
16248588|NCT01018225|Drug|darifenacin|7.5 or 15 mg darifenacin, once a day for 6 weeks
16248589|NCT01018225|Drug|Placebo|Placebo pill, once a day, for six weeks
16248590|NCT01018212|Other|Cicatrix cream|"We will be carried out the topical application of the product (Cicatrix cream) in the lesions auto administration three times a day during four months, being controlled by the specialist in months consultations.
~The dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application."
16248591|NCT01018199|Other|CRP|C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
16248592|NCT01018199|Other|PCT|Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy
16248593|NCT01018186|Drug|Fluticasone Furoate/GW642444|Combination inhaled corticosteroid and long-acting beta2-agonist
16248594|NCT01018186|Drug|Fluticasone propionate|Inhaled corticosteroid
16248595|NCT01018173|Drug|placebo|sc weekly
16248596|NCT01018173|Drug|taspoglutide|10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
16248597|NCT01018160|Drug|Rabeprazole Sodium|10mg - 20mg tablet once or twice daily for 12 weeks
16248598|NCT01018147|Procedure|4-dimensional computed tomography|Undergo 4-D CT imaging
16248599|NCT01018134|Drug|Desoximetasone 0.05% once daily|Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
16248600|NCT01018134|Drug|Desoximetasone 0.05% twice daily|Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
16248601|NCT01018134|Drug|Desoximetasone 0.25% once daily|Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
16248602|NCT01018134|Drug|Desoximetasone 0.25% once daily|Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
16248603|NCT01018134|Drug|Vehicle once daily|Vehicle topical spray administered to affected areas once daily for 28 days
16248604|NCT01018134|Drug|Vehicle twice daily|Vehicle topical spray administered to affected areas twice daily for 28 days
16248649|NCT01017822|Radiation|3-dimensional conformal radiation therapy|
16248606|NCT01018121|Other|Pediatrician Counseling|A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
16248607|NCT01018108|Procedure|Single Photon Emission Computed Tomography|Undergo single photon emission computed tomographt imaging
16248608|NCT01018108|Procedure|Acupuncture Therapy|Undergo acupuncture
16248609|NCT01018108|Other|Questionnaire Administration|Ancillary study
16248610|NCT01018108|Other|Laboratory Biomarker Analysis|Correlative Study
16248611|NCT01018095|Drug|Metronidazole|2 gm single dose versus 7 day 500 mg BID dose
16248612|NCT01018069|Drug|AEG35156|2 hr infusion of 650 mg of AEG35156 on days 1, 2, 3 and 8. Idarubicin 12 mg/m2 over 30 minutes daily on each of days 4, 5 and 6. The dose of cytarabine will be 1.5 g/m2 daily by continuous infusion x 4 days (days 4-7) in patients under age 65 and x 3 days (days 4-6) in patients age 65 and above.
16248613|NCT01018056|Drug|D-serine|The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
16248614|NCT01018056|Drug|Riluzole|The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
16248615|NCT01018056|Drug|Placebo|Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
16248616|NCT01018043|Other|Adult Cancer Patients|Tracking anemia management in Adult Cancer Patients
16248617|NCT01018030|Drug|FFNS 110 mcg QD|Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
16248618|NCT01018030|Drug|FFNS 110 mcg BID|Active Nasal Spray (AM) and Active Nasal Spray (PM)
16248619|NCT01018030|Drug|Placebo Nasal Spray|Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)
16248620|NCT01018017|Drug|Placebo|For placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
16248621|NCT01018017|Drug|SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250mg SRT2104.
16248622|NCT01018004|Other|follow-up care|
16248623|NCT01018004|Other|questionnaire administration|
16248624|NCT01018004|Procedure|quality-of-life assessment|
16248625|NCT01017991|Other|Milk based infant formula with probiotic|formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
16248626|NCT01017991|Other|Milk based infant formula|supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
16248627|NCT01017978|Procedure|MRI Scan of soft tissue tumor|MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.
16248628|NCT01017965|Device|Actimeter + blood pressure monitoring|Patients will receive an actimeter that they will wear for 3 days and an ambulatory blood pressure monitoring device that they will keep for 24 hours.
16248629|NCT01017952|Drug|FF/GW642444 Inhalation Powder|Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
16248630|NCT01017952|Drug|GW642444 Inhalation Powder|Long Acting Beta Agonist(LABA) Inhalation Powder
16248631|NCT01017939|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg tablets administered orally once daily beginning on Cycle 1 Day 1 up to the time of disease progression
16248632|NCT01017939|Drug|Prednisone|Prednisone 5mg tablets administered orally twice daily beginning on Cycle 1 Day 1 up to the time of disease progression
16248633|NCT01017939|Drug|Dextromethorphan hydrobromide|Dextromethorphan hydrobromide 30 mg capsules administered orally on Cycle 1 Day -8 and Cycle 1 Day 8 under fasting conditions
16248634|NCT01017939|Drug|Theophylline|Theophylline 100 mg tablets administered orally on Cycle 1 Day -8 and Cycle 1 Day 8 under fasting conditions
16248635|NCT01017926|Drug|Triazolam|Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
16248636|NCT01017926|Drug|Triazolam|Tablets, 0.25 mg, single-dose, 1 period of 3 three days.
16248637|NCT01017913|Other|TENS|The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.
16248638|NCT01017913|Other|Interferential currents|The IFC was adjusted to a base frequency of 4000 Hz, with a modulation frequency range of 20 Hz, ∆F of 10 Hz and slope of 1/1, in quadripolar mode.
16248639|NCT01017900|Procedure|local excision|surgical excision by orthopaedic surgeon under local anesthesia
16248640|NCT01017887|Device|Airseal access port for laparoscopic surgery|The investigators will utilize this access port that is already approved by the FDA for it's intended use in laparoscopic surgery. The investigators are simply measuring the percentage of carbon dioxide in the peritoneal cavity.
16248641|NCT01017887|Device|Standard Laparoscopy ports|Prospective monitoring of CO2 levels during laparoscopic surgery with standard access ports.
16248642|NCT01017874|Drug|Pemetrexed|500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.
16248643|NCT01017874|Drug|Cisplatin|75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
16248644|NCT01017874|Drug|Gefitinib|250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
16248645|NCT01017874|Drug|Gefitinib|250 milligrams (mg) administered orally once a day, every day of 21-day cycles administered as a monotherapy
16248646|NCT01017822|Biological|conatumumab|
16248647|NCT01017822|Drug|capecitabine|
16248648|NCT01017822|Drug|gemcitabine hydrochloride|
16248650|NCT01017809|Drug|Aprepitant|Cycle 1, day 2 to 17: Emend 80mg once daily in the morning on days 2 through 17 Cycles 2-6 (optional extension arm): same Emend dosing
16248651|NCT01017796|Drug|N-acetylcysteine and ascorbic acid|1200mg acetylcysteine and 2g ascorbic acid in 200 ml 0,9% normal saline at least 2 hours before the start of the index procedure, followed by 1200mg acetylcysteine and 1,5g ascorbic acid the night and the morning after the examination.
16248652|NCT01017783|Behavioral|Dietary substitution A|Substitution of calorie-dense item with lower calorie choice A
16248653|NCT01017783|Behavioral|Dietary Substitution B|Substitution of calorie-dense item with lower calorie option B
16248654|NCT01017783|Behavioral|Healthy Choices|Multiple healthy choices presented with self-selection of choices used
16248655|NCT01017770|Drug|Artesunate-amodiaquine|Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
16248656|NCT01017770|Drug|Artemether-lumefantrine|Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
16248657|NCT01017757|Procedure|High-resolution CT scanning|High-resolution CT scanning
16248658|NCT01017744|Device|Anesthetic Conserving Device|"Ventilation in PSV with the Anesthetic Conserving Device with remifentanil
~Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane"
16248659|NCT01017731|Biological|IMC-1121B|IMC-1121B (Ramucirumab) 10 mg/kg intravenously (IV) over 60 minutes, once every 3 weeks for minimum of 9 weeks.
16248660|NCT01017731|Drug|Moxifloxacin|Administered orally
16248661|NCT01017731|Drug|Diphenhydramine|Administered IV
16248662|NCT01017692|Procedure|MRI|MRI of lumbar spine for subjects presenting with spinal stenosis symptoms
16248663|NCT01017679|Drug|Gefitinib 500mg/Gefitinib 250mg|Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively
16248664|NCT01017666|Drug|BIIB014|BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d
16248665|NCT01017666|Drug|Placebo|Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d
16248666|NCT01017653|Drug|Irinotecan|Irinotecan: for those patients on an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. For those not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.
16248667|NCT01017653|Drug|Panitumumab|Panitumumab, 6 mg/kg, as an intravenous infusion every other week. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.
16248668|NCT01017640|Other|Laboratory Biomarker Analysis|Correlative studies
16248669|NCT01017640|Drug|Mitomycin|Given IV
16248670|NCT01017640|Drug|Veliparib|Given PO
16248671|NCT01017627|Other|Early anemia diagnosis and treatment|Patients returning to the unit are immediately assessed and treated for anemia
16248672|NCT01017627|Other|No change from normal routine|Normal unit policy for labs and anemia treatment
16248673|NCT01017614|Drug|Monofer|"administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained
~administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained"
16248674|NCT01017614|Drug|Iron Sulphate|200 mg daily
16248675|NCT01017601|Biological|Seneca Valley virus-001|Given IV
16248676|NCT01017601|Other|placebo|Given IV
16248677|NCT01017588|Device|PSU lumbar back support|wear PSU back supprt during doing rubber tapper
16248678|NCT01017575|Drug|Daclatasvir|Tablets, Oral, 10 mg, daily, 24-48 weeks
16248679|NCT01017575|Drug|Daclatasvir|Tablets, Oral, 60 mg, daily, 24-48 weeks
16248680|NCT01017575|Drug|Placebo|Tablets, Oral, 0 mg, daily, 48 weeks
16248681|NCT01017575|Drug|Peginterferon alfa-2a|Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
16248682|NCT01017575|Drug|Ribavirin|Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
16248683|NCT01017549|Radiation|Electronic brachytherapy (Axxent System)|3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
16248684|NCT01017536|Biological|AERAS-402|AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
16248685|NCT01017536|Biological|Placebo|Placebo was the identical buffer solution in which AERAS-402 is formulated.
16248686|NCT01017523|Behavioral|Telephone support and behavior change|Diabetes self-management education provided over the telephone either for individual or couples
16248687|NCT01017523|Other|Diabetes self-management education|Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
16248688|NCT01017510|Device|Subcutaneous injection luer syringe|"Right scalp: Luer syringe.
~Left scalp: syringe without a needle.
~All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml.
~The distance between injection locations will be 1 cm."
16248689|NCT01017510|Device|DERMOJET (a syringe without a needle)|"Right scalp: Luer syringe.
~Left scalp: syringe without a needle.
~All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml.
~The distance between injection locations will be 1 cm."
16248690|NCT01017497|Radiation|Stereotactic Radiosurgery|PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;
16248691|NCT01017484|Other|DASH, Control|controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level.
16248692|NCT01017471|Procedure|Limited incision using PSU retractor|carpal tunnel release using limited incision with PSU retractor will be done by orthopaedic hand surgeons
16248693|NCT01017458|Drug|MK0773|Three 25mg oral tablets MK0773 bid, for 12 weeks
16248694|NCT01017458|Drug|Comparator: testosterone enanthate|intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
16248695|NCT01017458|Drug|Comparator: placebo oral tablet|placebo oral tablet bid, for 12 weeks
16248696|NCT01017458|Drug|Comparator: placebo injection|placebo intramuscular injection q14d, for 12 weeks
16248697|NCT01017445|Other|Boonme stick exercise|individual exercise daily
16248698|NCT01017419|Behavioral|Counseling|Informational Counseling provided after hearing aid fitting
16248699|NCT01017406|Device|PSU heel cushion and plantar fascia specific stretching exercise|"Wear heel cushion during daily activity
~Plantar fascia stretching exercise 3 times per day"
16248700|NCT01017393|Drug|Ketamine|
16248701|NCT01017393|Drug|ketamine free|
16248702|NCT01017380|Drug|Celecoxib|celecoxib 400 mg 1 cap before surgery
16248703|NCT01017380|Drug|etoricoxib|120 mg 1 tab before surgery
16248704|NCT01017367|Drug|MDX-1100|MDX-1100 10 mg/kg i.v. over 60 minutes on days 1, 15, 29, 43, 57 and 71
16248705|NCT01017367|Drug|Placebo|Placebo
16248706|NCT01017354|Drug|Hidroferol® (ES)|24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
16248707|NCT01017354|Dietary Supplement|ViDe3 (CH)|60000 vitamin D3 orally and once per month
16248708|NCT01017354|Dietary Supplement|ViDe3 (CH)|24000 Vitamin D3 orally and once per month
16248709|NCT01017341|Device|PSU hip protector|hip protetor
16248710|NCT01017315|Drug|Baby talcum|50 grams apply locally prior cast application
16248711|NCT01017302|Drug|Placebo|Subcutenaous once weekly for 4 weeks
16248712|NCT01017302|Drug|Placebo|Single subcutaneous dose in week 5
16248713|NCT01017302|Drug|RO5095932|Escalating subcutaneous doses once weekly over a 4 weeks period
16248714|NCT01017302|Drug|RO5095932|Single subcutenaous dose in week 5
16248715|NCT01017289|Device|Quantum|Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
16248716|NCT01017276|Drug|ASP1585|oral
16248717|NCT01017263|Drug|Lis-dexamphetamine|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
16248718|NCT01017250|Radiation|Stereotactic Radiosurgery (SRS)|Tumor Volume < 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction
16248719|NCT01017250|Drug|Bevacizumab|Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS
16248720|NCT01017237|Drug|Dexmedetomidine|Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.
16248721|NCT01017237|Drug|Midazolam|Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
16248722|NCT01017237|Drug|Ketamine|Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.
16248723|NCT01017224|Other|18F-FAZA|PET scan
16248724|NCT01017211|Other|auricular acupuncture|"Experimental group to receive ear needles in the Battlefield Acupuncture points.
~Sham group to receive ear needles at points thought to be ineffective but standardized."
16248725|NCT01017198|Drug|BIIB021 and Food|Assessing the effect of food use on BIIB021
16248726|NCT01017198|Drug|BIIB0121 and Antacid|Assessing the effect of antacid use on BIIB021
16248727|NCT01017185|Drug|HF10|
16248728|NCT01017172|Other|serologic testing|Serologic testing will be performed baseline, day 21 and day 42
16248729|NCT01017159|Drug|Subcutaneous immunoglobulin|The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
16248730|NCT01017146|Drug|Tazarotene foam|Tazarotene foam once a day application to the face
16248731|NCT01017146|Drug|Vehicle Foam|Vehicle Foam once a day application to the face
16248732|NCT01017133|Radiation|fludeoxyglucose F 18|Given IV
16248733|NCT01017133|Radiation|Fluorine F 18 EF5|Given IV
16248734|NCT01017133|Procedure|Positron emission tomography|Undergo scan
16248735|NCT01017120|Drug|Tazarotene Foam|Tazarotene foam once a day application to the face
16248736|NCT01017120|Drug|Vehicle Foam|Vehicle Foam once a day application to the face
16248737|NCT01017107|Drug|Activated protein C|24 micrograms/kg/hour intravenously for 96 hours
16248738|NCT01017094|Drug|silversulfadiazine|apply once a day
16248739|NCT01017081|Other|Physiotherapy|Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission
16248740|NCT01017081|Other|Positioning and cough|Non-mandatory request to maintain lateral positioning to improve air exchange and cough
16248741|NCT01017068|Drug|OME|4g/100ml) dose: п gutt tid x 1/52
16248742|NCT01017068|Drug|OME|(2g/100ml) dose: п gutt tid x 1/52
16248743|NCT01017068|Drug|OME|(1g/100ml) dose: п gutt tid x 1/52
16248744|NCT01017068|Drug|OME|(4g/100ml) dose: п gutt tid x 1/52
16248745|NCT01017068|Drug|OME|(2g/100ml) dose: п gutt tid x 1/52
16248746|NCT01017068|Drug|OME|(1g/100ml) dose: п gutt tid x 1/52
16248747|NCT01017055|Other|Voice and Swallowing evaluations|Fiberoptic exam to evaluate vocal cord and swallowing function
16248748|NCT01017042|Drug|colchicine tablets|colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)
16248749|NCT01017029|Drug|Everolimus|
16248750|NCT01017029|Drug|Mycophenolate mofetil + Everolimus|
16248751|NCT01017003|Drug|colchicine tablets|0.6mg colchicine tablet
16248752|NCT01017003|Drug|colchicine tablets|0.6mg q12 hours for 10 days
16248753|NCT01016990|Drug|valproic acid|
16248754|NCT01016990|Genetic|western blotting|
16248755|NCT01016990|Other|laboratory biomarker analysis|
16248756|NCT01016990|Other|pharmacological study|
16248757|NCT01016977|Drug|Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene|Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
16248758|NCT01016977|Drug|clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene|clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
16248759|NCT01016964|Device|HairMax LaserComb 2009 model 12 beam|HairMax LaserComb
16248760|NCT01016964|Device|Sham Device|Sham Device
16248761|NCT01016951|Drug|AZD9164 Turbuhaler®|"Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits.
~The COPD patients will receive a dose of 1000 µg."
16248762|NCT01016951|Drug|Placebo Turbuhaler®|Dry powder for inhalation via Turbuhaler, MAD
16248765|NCT01016912|Drug|BMS-790052|Tablets, Oral, 60 mg, daily, 24-48 weeks
16248766|NCT01016912|Drug|Placebo|Tablets, Oral, 0 mg, daily, 48 weeks
16248767|NCT01016912|Drug|Peginterferon alfa-2b|Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
16248768|NCT01016912|Drug|Ribavirin|Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
16248769|NCT01016899|Radiation|electronic brachytherapy|Post market observational study recording data form patients with skin cancer treated with electronic brachytherapy. Treatment is standard of care, and can vary in dose and fractionation schedule from patient to patient depending on radiation oncologist's judgement for best treatment for the patient.
16248770|NCT01016886|Drug|perindopril OR bisoprolol OR placebo|"perindopril- oral daily titrated does from 2mg up to 8mg
~bisoprolol- oral daily titrated dose from 2.5mg up to 10mg"
16248771|NCT01016873|Device|IRay|Low voltage stereotactic radiotherapy system
16248772|NCT01016860|Drug|OSI-906|OSI-906 will be given orally in tablets for one dose starting on Cycle 1 Day-3 then on Cycle 1 Day 2-4, 8-10 and 15-17. Cycle is 21 days. Subsequent cycles, dosing will start be Day 1-3, 8-10 and 15-17
16248773|NCT01016860|Drug|irinotecan|Irinotecan will be administered IV over 90 minutes on Day 1 and 8 of a 21-day cycle
16248774|NCT01016847|Drug|Montelukast|10 mg Q day
16248775|NCT01016847|Other|Sugar pill|Sugar pill that looks like Montelukast that will be given Q day
16248776|NCT01016834|Device|Sumavel DosePro|Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
16248777|NCT01016834|Drug|Sumatriptan|subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
16248778|NCT01016821|Drug|Oxycodone|Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes
16248779|NCT01016808|Drug|Q8003|Q8003 is a combination of morphine sulfate and oxycodone HCl
16248780|NCT01016808|Drug|Morphine sulfate|One morphine sulfate 12 mg IR capsule q6h
16248781|NCT01016808|Drug|Oxycodone HCl|One oxycodone HCl 8 mg IR Capsule q6h
16248782|NCT01016795|Drug|r-metHuSCF and Filgrastim|Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
16248783|NCT01016795|Drug|r-metHuSCF and Filgrastim|Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
16248784|NCT01016795|Drug|Chemotherapy plus Filgrastim|Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
16248785|NCT01016782|Drug|0444|A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days
16248786|NCT01016769|Drug|Temsirolimus + Weekly Paclitaxel + Carboplatin|"Temsirolimus Per dose escalation scheme Level 1 (15 mg) 2 (20 mg) Level 3 (25 mg) IVPB 30 minutes weekly (3 weeks on, 1 week off) days 1 and 8.
~Paclitaxel 80 mg/m2 IVPB 1 hour weekly (2 weeks on, 1 week off) days 1 and 8. Carboplatin AUC 1.5 IVPB 30 minutes days 1 and 8. On Day 15 of each cycle, patients begin the rest week."
16248787|NCT01016743|Device|repetitive transcranial stimulation (r-TMS)|Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).
16248788|NCT01016730|Drug|Bortezomib|Given IV
16248789|NCT01016730|Other|Laboratory Biomarker Analysis|Correlative studies
16248790|NCT01016730|Other|Questionnaire Administration|Ancillary studies
16248791|NCT01016717|Drug|Omeprazole|All patients will be taking omeprazole (Losec, Abic Inc., Israel) tablets 40 mg QD for 30 days
16248792|NCT01016717|Drug|Pantoprazole|Pantoprazole tablets (Controloc 40, 40 mg/day, Nycomed, Perrigo Inc., Israel). All patients will take pantoprazole tablets 40 mg QD for 30 days
16248793|NCT01016704|Behavioral|Incentive|Participants assigned to the experimental condition are reinforced via monetary incentives for demonstrating superior delivery of an evidence treatment to clients
16248794|NCT01016691|Drug|High Dose Drug Device|device inserted for 4 days
16248795|NCT01016691|Drug|Low Dose Drug Device|device inserted for 4 days
16248796|NCT01016691|Drug|Placebo Device|device inserted for 4 days
16248797|NCT01016691|Drug|bimatoprost 0.03%|one drop in each eye on one day only
16248798|NCT01016678|Drug|Treximet|85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
16248799|NCT01016678|Drug|Placebo|Dummy pill comparator
16248800|NCT01016665|Drug|Anastrozole|Tamoxifen 20mg and anastrozole 1 mg
16248801|NCT01016652|Device|etafilcon A multifocal contact lens|low-add multifocal contact lens
16248802|NCT01016652|Device|etafilcon A Contact Lens|standard sphere contact lens
16248803|NCT01016639|Other|oxaliplatin, capecitabine, radiotherapy|
16248804|NCT01016626|Drug|CKD-4101 tablet|"CKD-4101 tablet 1000 mg
~500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)"
16248805|NCT01016626|Drug|Mycophenolate Mofetil capsule|"Mycophenolate Mofetil capsule 1000 mg
~250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)"
16248806|NCT01016600|Drug|Lenalidomide|
16248807|NCT01016600|Drug|Azacitidine|
16248808|NCT01016574|Device|Support Device for Prone radiation therapy (Giro-Couch)|Boost irradiation is applied to the ipsilateral breast in eight fractions of 2Gy/Fx
16248809|NCT01016561|Radiation|intracavitary balloon brachytherapy|
16248810|NCT01016561|Radiation|external beam radiation therapy|
16248811|NCT01016561|Radiation|intensity-modulated radiation therapy|
16248812|NCT01016561|Radiation|radiation therapy treatment planning/simulation|
16248813|NCT01016561|Radiation|3-dimensional conformal radiation therapy|
16248814|NCT01016561|Drug|Cisplatin|
16248815|NCT01016548|Biological|AS03-adjuvanted H1N1 pandemic influenza vaccine|One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.
16248816|NCT01016522|Dietary Supplement|KetoCal|Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
16248817|NCT01016509|Drug|Insulin|Insulin infusion will be started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. During insulin infusion, oral feeding will be stopped and parenteral nutrition (13±5 Kcal/kg-1/day-1) will be started. After the start of insulin infusion protocol a glycemic control will be provided every hour in order to obtain three consecutive values that were within the goal range. The infusion will be lasted until stable glycemic goal (80-140 mg/dl) at least for 24 h. After glycemic goal will be maintained for 24 h, a parenteral nutrition was stopped and feeding will be started according to European guidelines. Subcutaneous insulin will be initiated at the cessation of the infusion. After discharge from the hospital, insulin will be given as short-acting insulin before meals and long-acting insulin in the evening for 30 days from PCI. The treatment goal will be a fasting blood glucose level of 90-140 mg/dl and a non-fasting level of <180 mg/dl.
16248818|NCT01016509|Drug|Insulin|Continuous insulin infusion of 50 IU Actrapid HM (Novo Nordisk) in 50 ml NaCl (0.9% using a Perfusor-FM pump) will be started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion will be tapered and eventually stopped.The infusion will be lasted until stable glycemic goal (180-200 mg/dl) at least for 24 h. After glycemic goal will be maintained for 24 h, a parenteral nutrition was stopped and feeding will be started according to European guidelines. Subcutaneous insulin will be initiated at the cessation of the infusion. After discharge from the hospital, insulin will be given as short-acting insulin before meals and long-acting insulin in the evening for 30 days from PCI in both group. The treatment goal will be fasting blood glucose and postprandial levels of <200 mg/dl.
16248819|NCT01016496|Other|action observation therapy|15 consecutive sessions of 18 minutes, plus repetition
16248820|NCT01016496|Other|repetition of gestures|15 consecutive session of visual games, plus repetition of gestures
16248821|NCT01016483|Drug|Pimasertib|
16248822|NCT01016483|Drug|Gemcitabine|
16248823|NCT01016483|Drug|Placebo|
16248824|NCT01016470|Dietary Supplement|VIUSID/ALZER|VIUSID/ALZER, 3 per day, oral, one year
16248825|NCT01016470|Dietary Supplement|Placebo|Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
16248826|NCT01016457|Device|Guardian RT|The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.
16248827|NCT01016431|Other|Rate-adaptive pacemaker programming|The ICD will be programmed in a AAI-R mode, with peak atrial stimulation rate set at 85% of maximal predicted heart rate, and ongoing protection VVI backup at 40 bpm
16248828|NCT01016431|Other|VVI at 40 bpm|ICDs will be programmed in VVI mode at 40 bpm
16248829|NCT01016418|Dietary Supplement|Bovine colostrum powder|Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for safety monitoring for an additional 4 weeks.
16248830|NCT01016379|Genetic|DNA analysis|
16248831|NCT01016379|Other|biologic sample preservation procedure|
16248832|NCT01016379|Other|laboratory biomarker analysis|
16248833|NCT01016366|Drug|Lu AA24493|Vials with solution for i.v. injection. 325mcg Lu AA24493 dosed 3 times per week for two weeks. Vials will be supplied in concentrations ready for injection.
16248834|NCT01016366|Drug|Placebo|Vials with solution for i.v. injection. Placebo dosed 3 times per week for two weeks.
16248835|NCT01016353|Device|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
16248836|NCT01016353|Device|BVPT|Barker's Vacuum Packing Technique
16248837|NCT01016340|Drug|MCS|MCS-5 Softgel 5 mg
16248838|NCT01016327|Drug|NMS-1116354|Oral daily administration for 7 consecutive days every 14 days
16248839|NCT01016314|Device|Aspen Spinous Process System|Aspen Spinous Process System is an interspinous process fixation device
16248840|NCT01016314|Device|Pedicle Screw Fixation|Pedicle Screws are used for the fixation of the spine
16248841|NCT01016301|Other|Pharmacist service|Medication Review, medication report
16248842|NCT01016275|Device|Misago (stent placement)|Misago iliac stent
16248843|NCT01016262|Drug|MAX-002|MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.
16248844|NCT01016262|Drug|Placebo|Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
16248845|NCT01016262|Drug|Canasa®|Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
16248846|NCT01016249|Drug|Treatment 1. (5% Hypertonic saline + Epinephrine)|Nebulization of 4ml 5% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
16248847|NCT01016249|Drug|Treatment 3. (3% Hypertonic saline + Epinephrine)|Nebulization of 4ml 3% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
16248848|NCT01016249|Drug|Treatment 2. (Normal saline + Epinephrine)|Nebulization of 4ml 0.9% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
16248849|NCT01016223|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks
16248850|NCT01016223|Drug|placebo|Matched placebo swallowed two puffs twice daily
16248851|NCT01016210|Drug|Leuveris|IV
16248852|NCT01016210|Drug|Leuveris|All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist. Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.
16248853|NCT01016197|Procedure|extensor tendon repair|Surgical repair of extensor tendon with bone anchor and splinting
16248854|NCT01016197|Procedure|Mallet splint for 4 weeks|"The patient will wear a mallet splint for fours weeks and then mobilise their finger."
16248855|NCT01016184|Dietary Supplement|Vitamin D|Oral vitamin D 100,000 IU
16248856|NCT01016184|Dietary Supplement|Placebo|Placebo
16248857|NCT01016158|Drug|Umbilical cord serum eyedrops|20% umbilical cord serum eye drops 3 to 4 times a day
16248858|NCT01016145|Drug|Antipsychotics|Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
16248859|NCT01016145|Drug|Antipsychotics|Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.
16248860|NCT01016132|Device|lotrafilcon A contact lens|Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.
16248861|NCT01016119|Drug|Folrex|Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
16248862|NCT01016119|Drug|Placebo|Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
16248863|NCT01016106|Genetic|Buccal Swab|During a single visit, a subject data collection form will be completed and DNA will be extracted from samples (buccal swabs) and then analyzed at IBT laboratories in Lenexa, Kansas.
16248864|NCT01016093|Drug|Zoledronic acid|Zoledronic acid 4 mg adjusted dose based on renal function IV 15-minute infusion every 3 months for a total of one year ( 4 doses ) beginning as soon as possible after randomization.
16248865|NCT01016093|Drug|Placebo|Placebo
16248866|NCT01016080|Drug|glutathione|250 mg capsules, twice daily, orally
16248867|NCT01016080|Drug|placebo|250 mg capsules, twice daily, orally
16248868|NCT01016067|Device|INFUSE/MASTERGRAFT|INFUSE® (rhBMP-2) on an absorbable collagen sponge (ACS) and MASTERGRAFT® granules with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)
16248869|NCT01016067|Procedure|Autograft bone|Autogenous bone graft with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)
16248870|NCT01016054|Biological|AGS-8M4|IV infusion
16248871|NCT01016054|Drug|Pegylated liposomal doxorubicin (PLD)|IV infusion
16248872|NCT01016054|Drug|gemcitabine|IV infusion
16248873|NCT01016054|Drug|carboplatin|IV infusion
16248874|NCT01016041|Device|everolimus stent|stenting
16248875|NCT01016041|Device|paclitaxel stent|stenting
16248876|NCT01016028|Behavioral|Questionnaire|3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.
16248877|NCT01016028|Behavioral|Sensory Tests|Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.
16248878|NCT01016028|Behavioral|Interview|First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.
16248879|NCT01016015|Biological|Cixutumumab|Given IV
16248880|NCT01016015|Other|Laboratory Biomarker Analysis|Correlative studies
16248881|NCT01016015|Drug|Temsirolimus|Given IV
16248882|NCT01016002|Drug|Temoporfin|"Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min.
~Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan"
16248883|NCT01015989|Other|CARE+ Kenya brief computer risk assessment session|The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. We will repeat the session every 3 months up to 9 months total.
16248884|NCT01015989|Other|CARE+ Kenya computer counseling session|The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. The computer will let patients look at short videos on various HIV medicine and HIV risk reduction topics and will then help patients create a health plan. Patients will get an anonymous print out at the end of the session and can choose to share with health care provider. There are questions about depression, suicide, or domestic violence. If a patient's answers indicate that they may be depressed, suicidal, or currently in an abusive relationship, we will refer them to a health worker at the clinic. We will repeat the session every 3 months up to 9 months total.
16248885|NCT01015976|Procedure|bariatric surgery|Roux en Y bariatric surgery
16248886|NCT01015976|Other|control|No surgery
16248887|NCT01015963|Other|laboratory biomarker analysis|Perform DNA sample analysis
16248888|NCT01015950|Dietary Supplement|Plumpy'Sup|Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
16248889|NCT01015950|Dietary Supplement|Local food supplement|"Local foods (millet flour, cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder (Mix Me) are provide, according to the national Mali CMAM protocol when special processed foods are not available."
16248890|NCT01015950|Dietary Supplement|Misola|Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
16248891|NCT01015950|Dietary Supplement|SCSB|Processed, fortified, corn-soy-milk-based food blend (SCSB for malnourished children, to be supplied by the World Food Program) to provide an additional 500 kcal/day
16248892|NCT01015937|Drug|Turmeric extract|turmeric 500 mg TID for 45 days
16248893|NCT01015937|Drug|Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker|maximum dosage as patient tolerated for 45 days
16248894|NCT01015924|Procedure|plate osteosynthesis|Patients are operated upon within 3 w of the fracture
16248895|NCT01015924|Procedure|ESIN|Elastiv stable intramedullary nailing
16248896|NCT01015911|Drug|SGN-75|SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
16248897|NCT01015898|Radiation|photodynamic therapy|treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
16249000|NCT01015209|Device|Chitosan- N- Acetylcysteine eye drops|Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days
16248898|NCT01015872|Device|CPAP treatment|CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects.
16248899|NCT01015859|Device|Pacing mode|To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing
16248900|NCT01015846|Other|Exercise|Redcord (sling exercise) and traditional exercise
16248901|NCT01015846|Other|Core stability exercise|Traditional core stability exercise
16248902|NCT01015833|Drug|Doxorubicin Hydrochloride|Given IV
16248903|NCT01015833|Other|Laboratory Biomarker Analysis|Correlative studies
16248904|NCT01015833|Other|Pharmacogenomic Study|Correlative studies
16248905|NCT01015833|Drug|Sorafenib Tosylate|Given PO
16248906|NCT01015820|Procedure|EGD with EUS|EUS was performed in order to measure blood flow in duodenum.
16248907|NCT01015820|Device|4D-ELF|During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
16248908|NCT01015807|Drug|Bupivacaine Placebo|2 x 20mL 0.9% NaCl
16248909|NCT01015807|Drug|Clonidine Placebo|2 x 1mL 0.9% NaCl
16248910|NCT01015807|Drug|Bupivacaine|2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
16248911|NCT01015807|Drug|Clonidine|2 x 1ml Clonidine = 150 µg Clonidine
16248912|NCT01015794|Drug|ephedrine hydrochloride|single oral dose, 1mg/kg body weight
16248913|NCT01015794|Drug|ephedrine hydrochloride|single dose of 1 mg/kg body weight
16248914|NCT01015781|Procedure|Progressive Tinnitus Management|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
16248915|NCT01015781|Procedure|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
16248916|NCT01015768|Device|ReNu Multiplus multipurpose disinfecting solution|A new lens (PureVision) soaked 6 hours to overnight in ReNu Multiplus
16248917|NCT01015768|Device|Control|A new lens (PureVision) is soaked for two hours in non-preserved saline
16248918|NCT01015755|Behavioral|combined therapy treatment|mouth care
16248919|NCT01015742|Drug|Stem cell Transplantation|"Busulfan: 3.2 mg/kg IV daily on days -7 to -4
~Cyclophosphamide : 60 mg/m² daily on days -3 to -2
~Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2
~Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90
~Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant."
16248920|NCT01015729|Drug|Esomeprazole/ASA Fixed Combination|Capsule, oral, single dose
16248921|NCT01015729|Drug|Esomeprazole|oral, single dose
16248922|NCT01015729|Drug|ASA|Tablet, oral, single dose
16248923|NCT01015716|Behavioral|Intervention-group|Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
16248924|NCT01015716|Behavioral|Control-group|Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
16248925|NCT01015703|Biological|CoVaccine HT|intramuscular injection, dose escalation
16248926|NCT01015677|Drug|MK-6913|
16248927|NCT01015677|Drug|17-β estradiol|
16248928|NCT01015677|Drug|Placebo to MK-6913|
16248929|NCT01015677|Drug|Placebo to 17-β estradiol|
16248930|NCT01015677|Drug|MK-6913 25 mg|
16248931|NCT01015664|Drug|temsirolimus|10, 15, or 25 mg IV over 30 minutes on Days 1, 8, 15 and 22
16248932|NCT01015664|Drug|cisplatin|75 mg/m2 IV over 60 minutes on day 1
16248933|NCT01015664|Drug|cetuximab|400 mg m2 on Day 1 of Cycle 1, then 250 mg/m2 IV over 60 minutes on Days 1, 8, 15, and 22
16248934|NCT01015651|Drug|remifentanil|anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.
16248935|NCT01015651|Drug|remifentanil|anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.
16248936|NCT01015638|Drug|Clindamycin and BPO 5% gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
16248937|NCT01015638|Drug|Clindamycin phosphate and benzoyl peroxide 2.5% gel.|Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel
16248938|NCT01015625|Procedure|Surgery|lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
16248939|NCT01015625|Procedure|Surgery on Demand|if necessary local therapy on demand
16248940|NCT01015612|Device|Medtronic CoreValve® System|The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
16248941|NCT01015599|Behavioral|HOP'N After-school Program|Daily 30 minutes of physical activity following CATCH guidelines, Daily healthful snack with fruit/vegetables, Weekly nutrition and physical activity education based on social cognitive theory.
16248942|NCT01015586|Drug|Lamotrigine|Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
16248943|NCT01015586|Drug|Placebo|Placebo once daily for 12 weeks
16248944|NCT01015573|Device|magnetic sensor system to measure the movements of finger tapping|
16248945|NCT01015560|Drug|anti-CCR2 monoclonal antibody MLN1202|
16248946|NCT01015560|Genetic|polymorphism analysis|
16248947|NCT01015560|Other|laboratory biomarker analysis|
16248948|NCT01015547|Drug|Infliximab plus methotrexate|IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
16249001|NCT01015196|Drug|Zavedos|
16249002|NCT01015196|Drug|Cerubidine|
16249003|NCT01015183|Drug|Zinc Sulfate|Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy
16248949|NCT01015547|Drug|Combination of DMARDs|IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly, SSZ 40mg/kg up to 2000mg daily, HCQ 5mg/kg daily. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
16248950|NCT01015547|Drug|Methotrexate alone|Oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
16248951|NCT01015534|Drug|Temozolomide|
16248952|NCT01015534|Radiation|Whole brain irradiation|
16248953|NCT01015521|Drug|Aminoflavone Prodrug|Aminoflavone Prodrug administered D1, D8 of 21-day cycle
16248954|NCT01015508|Other|Very Low Energy Diet (VLED)|a VLED (Modifast) for 2 months in order to reduce body weight
16248955|NCT01015508|Other|Weight maintenance|10 months
16248956|NCT01015495|Drug|ranibizumab|0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage
16248957|NCT01015482|Drug|Remifentanil|Remifentanil Infusion
16248958|NCT01015482|Drug|Midazolam|Midazolam Infusion
16248959|NCT01015469|Procedure|Conventional laparoscopic Roux-en-Y gastric bypass|Conventional laparoscopic Roux-en-Y gastric bypass
16248960|NCT01015469|Procedure|conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring|conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)
16248961|NCT01015456|Drug|mycophenolate sodium|per oral, twice daily, for 12 months
16248962|NCT01015456|Drug|cyclophosphamide|intravenous, monthly, for 6 months
16248963|NCT01015443|Biological|Tecemotide|Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 918 microgram (mcg) of tecemotide (L-BLP25) at Week 1, 2, 3, 4, 5, 6, 7, and 8 (primary treatment phase) and then at 6-Week intervals, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinues for any other reason.
16248964|NCT01015443|Drug|Single low dose cyclophosphamide|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first administration of tecemotide.
16248965|NCT01015443|Drug|Placebo|Subjects will receive 8 consecutive weekly subcutaneous vaccinations of tecemotide (L-BLP25) matching placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinues for any other reason.
16248966|NCT01015443|Other|Saline|A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
16248967|NCT01015443|Other|Best Supportive Care (BSC)|The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
16248968|NCT01015430|Drug|Placebo (for RO4917523 ascending doses)|Placebo daily po
16248969|NCT01015430|Drug|Placebo (for RO4917523 fixed dose)|Placebo daily po
16248970|NCT01015430|Drug|RO4917523|RO4917523 ascending doses daily po
16248971|NCT01015430|Drug|RO4917523|RO4917523 fixed dose daily po
16248972|NCT01015417|Drug|Amoxicillin clavulanic acid|Postoperative administration of 2g, 3 times daily, since 5 days, of amoxicillin clavulanic acid (Augmentin or generic) oral form or parenteral form according to clinical patient and by the choice of medical teams
16248973|NCT01015417|Other|No medication|no postoperative antibiotics
16248974|NCT01015404|Drug|Trafermin|Administered to the bone defect during flap operation
16248975|NCT01015391|Drug|T2|1.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops
16248976|NCT01015391|Drug|Azathioprine|2.5mg/kg, PO (per oral) one time a day:until progression or unacceptable toxicity develops the first month:1.5mg/kg,PO,one time a day the second month:2.0mg/kg,PO,one time a day since the third month:2.5mg/kg,PO,one time a day
16248977|NCT01015378|Procedure|laparoscopid sigmoid resection|A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests
16248978|NCT01015365|Procedure|Cementless one-stage surgical revision|A Cementless one-stage surgical revision is to be performed for all included in the cohort.
16248979|NCT01015352|Drug|Azacitidine|Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
16248980|NCT01015352|Drug|Epoetin beta|"Epoetin beta : 60000U weekly SQ injections
~NeoRecormon®"
16248981|NCT01015339|Drug|Paclitaxel|80mg/m2 infusion,d1,d8 every 3 weeks
16248982|NCT01015339|Drug|capecitabine|Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
16248983|NCT01015339|Drug|capecitabine|Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
16248984|NCT01015339|Drug|cisplatin|80mg/m2, day 1 of every 3 weeks
16248985|NCT01015326|Other|Questionnaire|Administered questionnaire
16248986|NCT01015326|Other|Questionnaire|Administered questionnaire
16248987|NCT01015313|Other|intensive sodium management|"dietary sodium restriction
~avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms"
16248988|NCT01015300|Drug|Avastin|Patients will receive Bevacizumab (Avastin) 10mg/kg IV every two weeks for 6 months
16248989|NCT01015287|Drug|Placebo|Administered once orally
16248990|NCT01015287|Drug|Prasugrel|Administered orally
16248991|NCT01015261|Procedure|Bone Marrow Transplantation|Allogenic Bone Marrow Transplantation
16248992|NCT01015261|Procedure|Chemotherapy|"Cyclophosphamide 1200 mg/m2 D15
~Daunorubicin 45 mg/m2 D15-D18
~Vincristine 1 mg/m2 D15, D22
~Dexamethasone 24 mg/d D12-D28"
16248993|NCT01015248|Drug|Rituximab and Bendamustine|Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2
16248994|NCT01015235|Drug|Placebo|Subcutaneous infusion-once over 4 hours
16248995|NCT01015235|Drug|KAI-1678|Subcutaneous infusion-once over 4 hours
16248996|NCT01015235|Drug|Ketorolac Tromethamine|Active comparator, IV infusion, once
16248997|NCT01015222|Drug|Dasatinib|Starting dose of 50 mg daily PO for 28 day cycle
16248998|NCT01015222|Drug|Bevacizumab|Starting dose 5 mg/kg IV Day 1 and 15
16248999|NCT01015222|Drug|Paclitaxel|Starting dose 40 mg/m2 IV Day 1, 8 and 15
16249004|NCT01015183|Drug|Placebo|Placebo: as the same of intervention group
16249005|NCT01015170|Drug|bupropion HCl|150mg BID for up to 8 weeks + counseling
16249006|NCT01015157|Procedure|Roux-en-Y laparoscopic gastric bypass for morbid obesity|Primary bariatric surgery. Standard laparoscopic procedure with linear stapling divising of the stomach (Echelon 60 stapler, GOLD cartridges) with or with Seamguard reinforcement
16249007|NCT01015144|Drug|Tulip|Patients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy.
16249008|NCT01015131|Radiation|18F-FLT-PET/CT Imaging|Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.
16249009|NCT01015118|Drug|Placebo|comparator to BIBF 1120
16249010|NCT01015118|Drug|Paclitaxel|Paclitaxel (standard chemo-therapy)
16249011|NCT01015118|Drug|BIBF 1120|comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
16249012|NCT01015118|Drug|Carboplatin|Carboplatin (standard chemo-therapy)
16249013|NCT01015118|Drug|Paclitaxel|Paclitaxel (standard chemo-therapy)
16249014|NCT01015118|Drug|Carboplatin|Carboplatin (standard chemo-therapy)
16249015|NCT01015105|Other|observation|observation
16249016|NCT01015066|Drug|Buprenorphine/naloxone|Sublingual tablets, 2/0.5mg (ratio buprenorphine:naloxone = 4:1), three times a day for six months (doses may be adjusted based on an individual's response)
16249017|NCT01015066|Drug|Naltrexone|Oral tables, 50 mg/d, once a day for six months
16249018|NCT01015053|Procedure|bilateral ultrasound-guided rectus sheath block|Ultrasound is used to guide the deposition of Ropivacaine 0.2% 1cc/kg in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen.
16249019|NCT01015053|Procedure|Wound infiltration|Ropivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon.
16249020|NCT01015040|Drug|solifenacin succinate suspension|Oral
16249021|NCT01015040|Drug|solifenacin succinate tablet|Oral
16249022|NCT01015027|Biological|REGN668|4 IV Cohorts (Dose 1, 2, 3, & 4)
16249023|NCT01015014|Drug|AN3365|LP, 600 mg vial; reconstituted in Normal Saline
16249024|NCT01015014|Drug|Placebo|0.9% sodium chloride for injection
16249025|NCT01015001|Procedure|Active rTMS x sham (placebo) rTMS|"Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
~The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations."
16249026|NCT01015001|Procedure|sham rTMS|same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
16249027|NCT01015001|Procedure|(1Hz) rTMS applied over the left temporoparietal cortex|20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
16249028|NCT01014988|Drug|zanamivir aqueous solution|Zanamivir aqueous solution 10mg/mL is a clear, colorless, single use, sterile non-preserved preparation containing 10mg of zanamivir in each milliliter, and made isotonic with sodium chloride. It is presented in 20mL clear glass vials closed with rubber stoppers. Each vial contains 200mg of zanamivir.
16249029|NCT01014975|Biological|Plasmin (Human)|Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
16249030|NCT01014975|Biological|Plasmin (Human)|Plasmin (Human), 40 mg, delivered through a catheter into a thrombus
16249031|NCT01014975|Biological|Plasmin (Human)|Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
16249032|NCT01014962|Drug|Albaconozole|Albaconozole 400 mg oral once daily for 5 days
16249033|NCT01014962|Drug|Placebo|Placebo oral once daily for 5 days
16249034|NCT01014962|Drug|Albaconozole|Albaconozole 400 mg every 12 hours for 5 days
16249035|NCT01014962|Drug|Placebo|Placebo oral every 12 hours for 5 days
16249036|NCT01014962|Drug|Albaconozole|Albaconozole 400 mg oral every 8 hours for 5 days
16249037|NCT01014962|Drug|Placebo|Placebo oral every 8 hours for 5 days
16249038|NCT01014949|Other|Coronary microcirculation assessment|"Patients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014 coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine [140 ug/kg/min] to induce steady state maximal hyperemia."
16249039|NCT01014936|Drug|MSC2156119J|
16249040|NCT01014923|Behavioral|Teen driving intervention|Parents of new teen drivers receive guidebook to teach driving skills and safety behaviors; individual instruction on parent-child communication about driving; DVD demonstrating safe driving communication; and, 26-page booklet on driving goals and conversation topics
16249041|NCT01014910|Other|Continuous pulse oximetry monitoring|Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
16249042|NCT01014910|Device|Intermittent pulse oximetry monitoring|Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
16249043|NCT01014897|Device|tDCS|tDCS and sham will be applied in random order during standardized occupational therapy
16249160|NCT01014000|Device|Empirical group|Empirical implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
16249044|NCT01014884|Other|Multidisciplinary team interventions|The multidisciplinary team will determine which intervention should be applied to the participant in the intervention group based on their health risk assessment responses as well as medication review and visual inspection of the home.
16249045|NCT01014884|Other|Multidisciplinary team bimonthly visits either in person or via telephone.|
16249046|NCT01014884|Other|Usual case management and pharmacy management as provided by the health Plan and the pharmacy benefit manager|
16249047|NCT01014871|Drug|Botulinum Toxin Type A - Azzalure|One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
16249048|NCT01014871|Drug|Botulinum Toxin Type A - Vistabel|One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
16249049|NCT01014858|Drug|Donepezil|5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.
16249050|NCT01014845|Biological|hepatitis E vaccine|Intramuscularly given at 0, 1, 6m for three doses.
16249051|NCT01014845|Biological|Hepatitis B vaccine|Intramuscularly given at 0, 1, 6m for three doses.
16249052|NCT01014832|Drug|Intensive insulin therapy|Intensive insulin therapy
16249053|NCT01014806|Biological|Influenza VLP Vaccine|Single dose; 0.5mL
16249054|NCT01014806|Biological|TIV|Trivalent Influenza Vaccine 15ug/strain, commercially licensed
16249055|NCT01014793|Drug|cabergoline|cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal
16249056|NCT01014767|Drug|Carboplatin|"Standard Arm, Cycle 2: 350 mg/m2 IV over 2 hours on day 2 and 3
~All Arms, Cycles 4 & 6: 350 mg/m2 IV over 2 hours on day 2 and 3"
16249057|NCT01014767|Drug|Cisplatin|Cycles 1 & 2: 70 mg/m²/d IV over 6 hours on day 4
16249058|NCT01014767|Drug|Cyclophosphamide|"Standard Arm, Cycle 1: 1 g/m^2 IV over 1 hour on day 2 and 3
~All Arms, Cycles 3 & 5: 1 g/m^2 IV over 1 hour on day 2 and 3"
16249059|NCT01014767|Drug|Dactinomycin|Cycles 1 & 2: 45 µg/kg/day (max. 2 mg), IV on day 1
16249060|NCT01014767|Drug|Doxorubicin|Cycles 1 & 2: 25 mg/m²/day IV over 12 hrs on days 1-3
16249061|NCT01014767|Drug|Etoposide|"Standard Arm (1), Cycles 1 & 2:
~100 mg/m2 IV over 1 hour on days 1-5
~All Arms, Cycles 4-6:
~100 mg/m2 IV over 1 hour on days 1-5"
16249062|NCT01014767|Drug|Irinotecan|"Temozolomide Irinotecan arm (4), Cycles 1 & 2:
~50 mg/m2/day x 5 days as 1 hour IV infusions"
16249063|NCT01014767|Drug|Leucovorin|Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
16249064|NCT01014767|Drug|Methotrexate|5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
16249065|NCT01014767|Drug|Temozolomide|150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.
16249066|NCT01014767|Drug|Vincristine|"Standard Arm (1), Cycles 1 & 2 : 1.5 mg/m^2 IV over 15 minutes on day 5
~Doxorubicin/cisplatin arm (2), Cycles 1 & 2: 1.5 mg/m^2/day (max. 2 mg), i.v. on days 8, 15
~For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5"
16249067|NCT01014741|Drug|Ibutilide|0.25mg IV ibutilide after PV isolation prior to CFE ablation
16249068|NCT01014741|Drug|Placebo|Placebo after PV isolation prior to CFE ablation.
16249069|NCT01014728|Drug|propofol|100-200mcg/kg/min by infusion
16249070|NCT01014728|Drug|sevoflurane|1-3% of sevoflurane (expired)
16249071|NCT01014715|Other|Phase II - Preoperative Radiation followed by Lumpectomy.|Sequential investigative question. All procedures are standard of care
16249072|NCT01014702|Device|LensAR Laser System|Use of laser for capsulotomy and lens fragmentation
16249073|NCT01014702|Device|Conventional phacoemulsification|Use of standard techniques for capsulotomy and lens fragmentation
16249074|NCT01014689|Drug|Adapalene/ BPO gel with Lymecycline capsules|Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
16249075|NCT01014689|Drug|Adapalene/ BPO vehicle gel with Lymecycline capsules|Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
16249076|NCT01014676|Dietary Supplement|Probiotic|
16249077|NCT01014676|Other|Placebo|
16249078|NCT01014663|Behavioral|Traditional Therapeutic Exercise|The therapeutic exercise program will consist of warm-up and stretching, seated and standing range of motion activities, endurance and resistance training, balance training and a cool down. Training will take place for 36 sessions, three times/week for 60-90 minutes per session.
16249079|NCT01014663|Behavioral|Non-Contact Boxing Training|Non-contact boxing training will consist of warm-up and stretching, non-contact boxing training (including punching a focus mitt, speed and heavy punching bags), endurance training activities, strength and resistance training, and a cool down. Training will take place for 36 sessions, three times/week for 60-90 minutes per session.
16249080|NCT01014650|Drug|GLYX-13|single IV or SC dose
16249081|NCT01014650|Drug|IV normal saline|Single IV dose of normal saline
16249082|NCT01014637|Drug|Amorolfine (Antifungal)|Treatment with Amorolfine for 36 weeks
16249083|NCT01014637|Drug|RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)|Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.
16249084|NCT01014624|Drug|Prasugrel|"Prasugrel 10mg tablet administered once daily for 7 days.
~After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."
16249161|NCT01014000|Device|Echocardiography-guided approach|Echocardiography-guided implantation of the left ventricular lead during cardiac resynchronization therapy device implantation
16249162|NCT01013987|Drug|maraviroc|maraviroc: one 150 mg pill twice daily
16251565|NCT00996879|Drug|Midazolam|Syrup, Oral, 5 mg, Single dose, 2 days
16249085|NCT01014624|Drug|Clopidogrel|"Clopidogrel 75 mg tablet administered once daily for 7 days.
~After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."
16249086|NCT01014598|Drug|Cisplatin|Given intra-arterially via isolated lung suffusion
16249087|NCT01014598|Other|Pharmacological Study|Correlative studies
16249088|NCT01014585|Drug|Placebo|Placebo tablets administered orally twice daily
16249089|NCT01014585|Drug|Milnacipran|Milnacipran tablets administered orally twice daily
16249090|NCT01014572|Behavioral|Aerobic Exercise Training|Aerobic exercise training consisting of exercise of choice (walking, eliptical machine, stairstepper, stationary bike, etc.) 4 times per week for 40 minutes at a base pace, and two higher intensity steady state sessions per month.
16249091|NCT01014572|Drug|Alagebrium (generic: ALT-711)|The dosage of our drug, ALT-711, will be one 100 mg caplet by mouth twice per day for 12 months. Total dose per day 200 mg.
16249092|NCT01014572|Behavioral|Tai Chi and/or Yoga Training|Tai Chi or Yoga training includes a series of exercises that improve flexibility, balance and coordination. Training will be supervised by trained instructors. This training will occur 3 times per week.
16249093|NCT01014559|Drug|Oxycodone Naloxone|Oxycodone Naloxone PR Tablet taken twice daily
16249094|NCT01014559|Drug|Oxycodone PR Tablets|Oxycodone PR Tablets taken twice daily
16249095|NCT01014546|Drug|Arsenic Trioxide|Given PO
16249096|NCT01014546|Dietary Supplement|Ascorbic Acid|Given PO
16249097|NCT01014546|Other|Laboratory Biomarker Analysis|Correlative studies
16249098|NCT01014546|Other|Pharmacological Study|Correlative studies
16249099|NCT01014533|Drug|Placebo dispensed to subject.|Placebo for 11 days, (one pill at bedtime on nights 1 and 2, 2 pills at bedtime on nights 3-10, and 1 pill at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared.
16249100|NCT01014533|Drug|Gabapentin dispensed to subject.|After spending 3 baseline nights in the UM Sleep Lab, alcohol dependent subjects are randomized to receive either gabapentin or placebo for 11 days. (1 pill (600 mg) at bedtime on nights 1 and 2, 2 pills (totalling 1200 mg) at bedtime on nights 3-10, and 1 pill (600 mg) at bedtime on night 11, then D/C). On nights 8 - 10 of medication, subjects return to the lab and sleep 3 more nights with the same procedures.
16249101|NCT01014520|Drug|Gabapentin , Amitriptyline|"Capsule, 300 mg, oral, single dose 2 hours before surgery
~Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery"
16249102|NCT01014507|Drug|8 cycles BEACOPPesc plus oral contraceptive|
16249103|NCT01014507|Drug|8 cycles BEACOPPesc plus Goserelin|
16249104|NCT01014494|Device|Adaprev|Class III Medical Device
16249105|NCT01014481|Drug|tenofovir, lamivudine, efavirenz|initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment
16249106|NCT01014468|Drug|Ranibizumab (Intravitreal injection)|Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
16249107|NCT01014468|Drug|Bevacizumab (Intravitreal injection)|Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
16249108|NCT01014455|Behavioral|Informing surgical patients about CO monitoring|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
16249109|NCT01014455|Behavioral|a brief intervention recommending preoperative abstinence from smoking|a brief intervention that recommends fasting but does not mention that CO will be checked
16249110|NCT01014442|Drug|mycophenolate mofetil|1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation
16249111|NCT01014429|Drug|NMS-1286937|Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.
16249112|NCT01014416|Drug|Tolvaptan 15mg or 30mg or 60mg or Placebo|Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day
16249113|NCT01014403|Drug|enoxaparin|Enoxaparin 30 mg sq q 12 hours
16249114|NCT01014403|Drug|placebo|vehicle
16249115|NCT01014390|Device|WallFlex Biliary RX Fully Covered Stent System|Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
16249116|NCT01014377|Device|VascuActive|
16249117|NCT01014364|Drug|hydrocortisone|50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
16249118|NCT01014364|Drug|isotonic saline|intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
16249119|NCT01014351|Drug|Paclitaxel|Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
16249120|NCT01014351|Drug|Carboplatin|Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
16249121|NCT01014351|Drug|Everolimus|Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
16249122|NCT01014338|Drug|Fosinopril|10mg od
16249123|NCT01014338|Other|lactose|placebo
16249124|NCT01014325|Biological|Allergen extract|sublingual application
16249125|NCT01014325|Biological|Placebo|sublingual application
16249163|NCT01013987|Drug|Raltegravir|raltegravir : one 400 mg pill twice daily
16249164|NCT01013987|Drug|Darunavir/ritonavir|"darunavir : two 300 mg pills twice daily with meal
~ritonavir: one 100 mg pill twice daily with meal"
16249165|NCT01013974|Drug|GSK573719 250 μg|Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
16249126|NCT01014312|Behavioral|Depression Care Management (DCM)|Depression Care Management (DCM) includes: 1. Monitoring the course of the depressive disorder; 2. Contacting the referring primary care physician (PCP) and offering information on the patients' current psychiatric status and medical complaints and the treatment recommended by published pharmacotherapy guidelines; 3. Determining the nature and extent of stressors affecting the patients' clinical status and functioning; 4. Psychoeducation concerning depression and depression treatment, working with the patient to select an appropriate treatment based on informed treatment preferences, and emphasizing treatment adherence; and 5. Supportive psychotherapy.
16249127|NCT01014312|Behavioral|Enhanced Care|Primary Care Physicians will be informed by letter from a study psychologist of the participants' depression diagnosis and of suicidal ideation when present. They will have no direct assistance regarding depression treatment, but they will be educated on guideline-based antidepressant treatment recommendations. Moreover, research assistants will use a suicide risk protocol at baseline and at all follow-up assessment periods that mandates immediate contact with PCPs by telephone or beeper in cases with significant risk.
16249128|NCT01014299|Other|Recruitment maneuver|"Assigned interventions:
~No intervention after tracheal intubation (control group)
~Alveolar recruitment maneuver (RM group) immediately after intubation"
16249129|NCT01014273|Procedure|Percutaneous Coronary Intervention|
16249130|NCT01014260|Drug|Placebo|This is a randomized double-blind clinical trial of doxycycline 20 mg bid versus 100mg bid versus placebo, given for 3 months, to be conducted at a single center (JHH).
16249131|NCT01014260|Drug|Doxycycline|Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo
16249132|NCT01014247|Drug|Avelox (Moxifloxacin, BAY12-8039)|Single dose of 400 mg
16249133|NCT01014247|Drug|Placebo|Single dose of matching tablet
16249134|NCT01014234|Drug|Cyclosporins|These patients will undergo maintenance immunosuppressive treatment with cyclosporine + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.
16249135|NCT01014234|Drug|Rapamycin|These patients will undergo maintenance immunosuppressive treatment with rapamycin + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.
16249136|NCT01014221|Other|Acupuncture|acupuncture administered in 8 sessions over 4 weeks
16249137|NCT01014221|Drug|Prednisolone|2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
16249138|NCT01014208|Drug|OFATUMUMAB + DHAP|3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.
16249139|NCT01014208|Drug|RITUXIMAB + DHAP|3 cycles of treatment will be administered. Each cycle will last 21 days. rituximab dose: cycle 1, day 1 - 375 mg/m2; cycle 1, day 8 - 375 mg/m2; cycle 2, day 1 and cycle 3, day 1 - 375 mg/m2. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.
16249140|NCT01014195|Other|Neurocognitive and behavioral evaluation|The primary neurocognitive outcome will be performance on measures of cognitive flexibility and cognitive fluency. Functional behavior will be evaluated via the child or adult version of the Behavior Rating Inventory of Executive Function, using parent respondent for each version. The presence of ADHD and common comorbid conditions (i.e. depression, anxiety) will be determined with structured diagnostic interviews. Quality of life will be re-assessed with the PedQL.
16249141|NCT01014169|Behavioral|Note taking|The mothers in the intervention group will be given a pen and encouraged to take written notes in the notes section of a discharge envelope using their language of preference when receiving standard newborn discharge information.
16249142|NCT01014156|Drug|epoprostenol|titration up to 4 ng/kg/min
16249143|NCT01014143|Drug|Fluoride|Half mouth toothbrushing twice a day for four days.
16249144|NCT01014143|Drug|Chlorhexidine digluconate|Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
16249145|NCT01014143|Drug|Fluoride, triclosan|Half mouth Brushing twice daily
16249146|NCT01014130|Radiation|Hypofractionated radiotherapy (HypoRT)|Highly conformal hypofractionated radiotherapy to a total dose of 54 Gy given in 3 fractions of 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed.
16249147|NCT01014130|Radiation|Conventionally Fractionated Radiotherapy (ConRT)|Standard radiotherapy to a total dose of 60-66 Gy prescribed to an isodose covering the PTV. It will be delivered as 30-33 fractions over a period of six to six and a half weeks. If the use of chemotherapy is the institutional practice for this group of patients, concurrent carboplatin and paclitaxel will be given weekly (paclitaxel (45mg/m2/wk) and carboplatin (AUC=2/wk) for 6 weeks.
16249148|NCT01014117|Drug|Placebo|Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
16249149|NCT01014117|Drug|SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250mg of SRT2104.
16249150|NCT01014104|Drug|Methylprednisolone|Administration of Methylprednisolone
16249151|NCT01014104|Drug|Control|Normal salin injection
16249152|NCT01014091|Biological|GSK pandemic vaccine GSK2340272A|2 intramuscular injections
16249153|NCT01014078|Drug|Azithromycin Ophthalmic Solution, 1%|1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
16249154|NCT01014078|Drug|Placebo|1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
16249155|NCT01014052|Drug|QLT091001|oral QLT091001 administered once daily for 7 days
16249156|NCT01014039|Procedure|Flexible Sigmoidoscopy Screening arm|sigmoidoscopy screening
16249157|NCT01014026|Other|Screening test|Two Vaginal self sampling devices and HPV test
16249158|NCT01014013|Drug|ertapenem sodium (MK0826)|a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)
16249159|NCT01014013|Drug|Comparator: ceftriaxone sodium|a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)
16249166|NCT01013974|Drug|GSK573719 500 μg|Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
16249167|NCT01013974|Drug|GSK573719 1000 μg|Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation.
16249168|NCT01013974|Drug|GSK573719 matching Placebo|Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
16249169|NCT01013961|Biological|alemtuzumab|Given IV
16249170|NCT01013961|Biological|rituximab|Given IV
16249171|NCT01013948|Other|Non-Interventional|Non-Investigational Product (Survey Study)
16249172|NCT01013935|Other|CARE+ Spanish computer counseling session|The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. The computer will let patients look at short videos on various HIV medicine and HIV risk reduction topics and will then help patients create a health plan. Patients will get an anonymous print out at the end of the session and can choose to share with health care provider. There are questions about depression, suicide, or domestic violence. If a patient's answers indicate that they may be depressed, suicidal, or currently in an abusive relationship, we will refer them to a health worker at the clinic. We will repeat the session every 3 months up to 12 months total.
16249173|NCT01013935|Other|CARE+ Spanish brief computer risk assessment session|The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. We will repeat the session every 3 months up to 12 months total.
16249174|NCT01013909|Drug|Bifonazole spray once daily|Application of one dose daily by means of an metered dose
16249175|NCT01013909|Drug|Bifonazole spray twice daily|Application of two dose daily by means of an metered dose
16249176|NCT01013909|Drug|Placebo|Application of one dose daily by means of an metered dose
16249177|NCT01013909|Drug|Placebo|Application of one dose daily by means of an metered dose
16249178|NCT01013909|Drug|Lamisil Once|One application of Lamisil Once
16249179|NCT01013896|Behavioral|Motivational Interviewing|Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
16249180|NCT01013896|Other|Cystic Fibrosis Education|"Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
~The Cystic Fibrosis Education serves as the attention control group."
16249181|NCT01013870|Drug|Atorvastatin|In this Phase II randomized clinical trial of 200 MTBI subjects to evaluate atorvastatin as a neuroprotective agent, subjects will receive either active drug or placebo (1:1 randomization) for 7 days, starting within 24 hours of the brain injury. The dosage for subjects in the treatment group will be weight-based at 1mg/kgm, up to 80 mg, which will be the maximal dose. Subjects will be monitored at 3-4 days after injury by phone, then with follow-up visits at 1 week, 1 month, 3 months.
16249182|NCT01013870|Drug|Placebo|In this Phase II randomized clinical trial of 200 MTBI subjects to evaluate atorvastatin as a neuroprotective agent, subjects will receive either active drug or placebo (1:1 randomization) for 7 days, starting within 24 hours of the brain injury. For the placebo group, subjects will take a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for seven days, started within 24 hours of MTBI, and their outcome will be compared with the group of subjects receiving active drug. Subjects will be monitored at 3-4 days after injury by phone, then with follow-up visits at 1 week, 1 month, 3 months.
16249183|NCT01013857|Behavioral|Health coaching|Calling patients every week to discuss medication adherence
16249184|NCT01013857|Behavioral|Health coaching plus home titration|Calling patients every week and intensifying medications if appropriate based on physician-created algorithm
16249185|NCT01013844|Behavioral|Skin Self Examination Information and ABCDE Rule|Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.
16249186|NCT01013831|Drug|Erlotinib Hydrochloride|Given PO
16249187|NCT01013831|Other|Laboratory Biomarker Analysis|Correlative studies
16249188|NCT01013831|Other|Pharmacological Study|Correlative studies
16249189|NCT01013818|Drug|HGS1029|HGS1029 will be given as a 15-minute IV infusion (in the vein) once weekly for 3 consecutive weeks, followed by 1 week off.
16249190|NCT01013805|Radiation|External Beam Radiotherapy|"Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy.
~Weeks 8-10: as per Weeks 3-5"
16249191|NCT01013805|Drug|Oxaliplatin|"Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU).
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1."
16249192|NCT01013805|Drug|Fluorouracil|"Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.
~Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1"
16249193|NCT01013805|Drug|Leucovorin|Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
16249194|NCT01013805|Procedure|Surgical Resection|Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
16249242|NCT01013532|Drug|Cilostazol|Cilostazol 100mg bid
16249195|NCT01013792|Device|Wound Dressing|Acetate mesh carrier with ointment (water, PEGs)
16249196|NCT01013792|Device|Wound Dressing|Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
16249197|NCT01013779|Drug|Carboplatin|"During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation).
~After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1."
16249198|NCT01013779|Drug|Etoposide|After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
16249199|NCT01013779|Radiation|Radiotherapy|"Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions
~Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions"
16249200|NCT01013766|Drug|GSK1362885|100mg in the AM, 100mg in the PM, 50mg BID
16249201|NCT01013766|Drug|GSK1362885|100mg in the PM, 100mg in the AM, 50mg BID
16249202|NCT01013753|Drug|Placebo|Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler
16249203|NCT01013753|Drug|Olodaterol (BI 1744) high|Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
16249204|NCT01013753|Drug|Olodaterol (BI 1744) medium|Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
16249205|NCT01013753|Drug|Olodaterol (BI 1744) very low|Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
16249206|NCT01013753|Drug|Formoterol 12 mcg|Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups
16249207|NCT01013753|Drug|Olodaterol (BI 1744) low|Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
16249208|NCT01013740|Drug|Vinorelbine|Vinorelbine
16249209|NCT01013740|Drug|Lapatinib|Lapatinib
16249210|NCT01013740|Drug|Capecitabine|Capecitabine
16249211|NCT01013727|Radiation|SPECT : ECD-Tc99m - Neurolite, Bristol-Myers Squibb Medical Imaging|
16249212|NCT01013714|Procedure|Cardiac Sympathetic Denervation (CSD)|Cardiac sympathetic denervation is performed using an endoscopic procedure called VATS (video-assisted thoracoscopic sympathectomy). The surgeon removes the lower half of the stellate ganglia in addition to the thoracic ganglia of T2 - T4 on both the right and left side. The VATS procedure provides a minimally invasive endoscopic approach that is safe and effective. The procedure can be completed in less than 45 minutes on each side.
16249213|NCT01013714|Drug|Routine Care|Anti-arrhythmic medications are continued for the duration of the study unless discontinued or adjusted to due to drug toxicity, intolerance, or ICD shock. All anti-arrhythmic medications (whether in the routine care or surgical arm) can be adjusted at the discretion of the treating physician.
16249214|NCT01013701|Drug|fluticasone furoate|nasal steroid spray
16249215|NCT01013701|Other|placebo|nasal steroid vehicle without drug
16249216|NCT01013688|Procedure|Cardioblate® Surgical Ablation System|Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
16249217|NCT01013675|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in cell cultures
16249218|NCT01013675|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in egg (influvac ®)
16249219|NCT01013662|Procedure|glycemic control|exogenous insulin
16249220|NCT01013649|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-dimensional conformal radiation therapy
16249221|NCT01013649|Drug|Capecitabine|Given PO
16249222|NCT01013649|Drug|Chemotherapy|Given combination chemotherapy
16249223|NCT01013649|Drug|Erlotinib Hydrochloride|Given PO
16249224|NCT01013649|Drug|Fluorouracil|Given IV
16249225|NCT01013649|Drug|Gemcitabine Hydrochloride|Given IV
16249226|NCT01013649|Radiation|Intensity-Modulated Radiation Therapy|Undergo intensity-modulated radiation therapy
16249227|NCT01013649|Other|Laboratory Biomarker Analysis|Correlative studies
16249228|NCT01013649|Other|Quality-of-Life Assessment|Ancillary studies
16249229|NCT01013636|Procedure|Blood sampling|"Anaplasma diagnosis test : serology and PCR
~If presence of Anaplasma infection, proposition of treatment with doxycylin 200 mg once-a-day during 10 days"
16249230|NCT01013623|Procedure|Surgery|surgical resection to remove all known disease
16249231|NCT01013623|Procedure|Surgery plus 2 adjuvant doses of BCG|Patients in the surgical resection + BCG arm will have an additional two visits to receive BCG. The first dose of BCG will be given no earlier than 4 weeks after surgery, and the second BCG dose will follow 2 weeks later. The actual doses are determined by the patient's pre-study tuberculin-reactivity status. Patients with a pre-study PPD induration of ≥10 mm will be given half the normal dose of BCG. Those with PPD induration of ≥20 mm will be given 25% of the normal dose.
16249232|NCT01013623|Other|best medical therapy|Patients randomized to the Best Medical Therapy arm will decide on a course of medical therapy based on what the patient's medical oncologists feels is best for the patient. Best systemic medical therapy may include clinical trials of new agents or standard non-protocol treatments. Patients who progress on the best medical treatment arm may switch to a different medical therapy or, if still appropriate, may receive surgery.
16249233|NCT01013610|Drug|LNK-754|Escalating dose
16249234|NCT01013610|Drug|Placebo|Escalating dose
16249235|NCT01013597|Drug|LBH589|LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
16249236|NCT01013584|Dietary Supplement|cholecalciferol|daily dose
16249237|NCT01013571|Drug|insulin glargine|pre-filled disposable pen, in package of 5.
16249238|NCT01013571|Drug|Apidra (insulin glulisine)|pre-filled disposable pen, in package of 5
16249239|NCT01013558|Drug|Remifentanil|0.15 microgram/kg/min continuous infusion.
16249240|NCT01013558|Drug|saline|continuous infusion
16249241|NCT01013545|Behavioral|JAE Intervention|The overall goal in each session will be for the caregiver-child dyad to be in a state of supported or coordinated joint engagement. In this state the child is aware of the other's activity, and may actively coordinate their attention between an object/toy and the caregiver. The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist.
16249245|NCT01013532|Drug|placebo of cilostazol|same shape and size of active cilostazol
16249246|NCT01013532|Drug|placebo of aspirin|same size and shape of active aspirin 100mg
16249247|NCT01013532|Device|ankle-brachial index (ABI)|measurement of ABI every years during follow up
16249248|NCT01013532|Device|intima-medial thickness (IMT)|ultrasound measured IMT of both common carotid arteries
16249249|NCT01013532|Device|new asymptomatic brain hemorrhage|asymptomatic macrobleedings or microbleedings on GRE images
16249250|NCT01013532|Device|new ischemic lesions on follow-up FLAIR images|any new ischemic lesions
16249251|NCT01013506|Drug|IGF-1R inhibitor OSI-906|Given orally
16249252|NCT01013506|Drug|erlotinib hydrochloride|Given orally
16249253|NCT01013506|Drug|goserelin|Given subcutaneously
16249254|NCT01013506|Drug|letrozole|Given orally
16249255|NCT01013480|Drug|Arbaclofen|A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID
16249256|NCT01013467|Behavioral|"CoCo colour coded blood pressure control"|The patients in the intervention group will receive a colour-coded blood pressure record booklet. The corresponding colour coded areas are divided into three areas of green, yellow and red following a traffic light system. The green area covers blood pressure readings up to a maximum of 140/90 mmHg, the yellow area includes systolic readings over 140 to 180 mm Hg and diastolic readings over 90 to 110 mmHg. The red area covers systolic readings over 180 mmHg and diastolic readings over 110 mmHg.
16249257|NCT01013454|Drug|varenicline free base patch|varenicline transdermal delivery system (6.0 mg payload [drug amount loaded in each patch]) will be applied to the upper back over a single 24 hour period
16249258|NCT01013441|Biological|Infusion of CD3/CD28 stimulated T cells|Receive CD3/CD28 stimulated T cells after fludarabine or alemtuzumab based chemotherapy
16249259|NCT01013428|Other|Ultrasound|Ultrasound will be used to evaluate tendons.
16249260|NCT01013415|Drug|HAART|
16249261|NCT01013415|Biological|T cells|
16249262|NCT01013402|Drug|Human insulin|The test was performed in the morning after an overnight fasting and the patients remained supine during the procedure. Two intravenous lines in both arms were established before the procedure. Venous blood was obtained for serum glucose before regular insulin (0.1 U/kg ) is injected and 30 and 45 minutes thereafter. If adequate hypoglycemia was not achieved at this period, a second dose of regular insulin (0.05U/kg) was injected intravenously. In subjects who had not reached the aimed hypoglycemia levels, the test was performed in another day with a higher initial insulin dosage (0.2U/kg).
16249263|NCT01013402|Drug|Human Insulin|0.1U/kg IV pulse.
16249264|NCT01013389|Procedure|Actifuse ABX|bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion
16249265|NCT01013389|Procedure|INFUSE, plus master granules (MGG)|bone substitute in posterolateral instrumented lumbar fusion with interbody fusion
16249266|NCT01013376|Drug|MC-1101|MC-1101 1.0%
16249267|NCT01013376|Drug|Vehicle|Vehicle
16249268|NCT01013363|Other|iPod Nano digital music player|Digital music player pre-loaded with 10 playlists to be used intra-operatively by the participant randomized to the intervention group.
16249269|NCT01013337|Procedure|acupuncture therapy|
16249270|NCT01013337|Procedure|sham intervention|Placebo acupuncture
16249271|NCT01013324|Drug|XL147 (SAR245408)|dosed as capsules taken orally daily
16249272|NCT01013298|Device|video-guided PCT|extubation and then re-intubation with the ETT-TVT, followed by video monitoring of the PCT procedure via the ETT-TVT
16249273|NCT01013285|Biological|bevacizumab|
16249274|NCT01013285|Drug|temozolomide|
16249275|NCT01013285|Radiation|external beam radiation therapy|
16249276|NCT01013272|Drug|Entecavir|Entecavir 0.5mg orally daily
16249277|NCT01013272|Drug|Lamivudine|Lamivudine 100mg orally, daily
16249278|NCT01013259|Drug|Mutaflor|1 capsule contains 2.5 - 25 billion viable bacteria of the strain E. coli Nissle 1917, 1 capsule daily over the first 4 days, 2 capsules daily until the end of treatment
16249279|NCT01013259|Drug|Placebo|1 placebo capsule matching the experimental treatment, according to the experimental arm
16249280|NCT01013246|Other|1-hour video game play|FIFA 2009, a football video game played on Xbox 360
16249281|NCT01013233|Behavioral|cognitive training|cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.
16249282|NCT01013233|Other|control group|no intervention
16249283|NCT01013220|Other|Depression Product Detailing|"two hour academic detailing of depression management products to employees with responsibility for purchasing health care benefits
~technical assistance in purchasing high quality depression management products"
16249284|NCT01013220|Other|Depression HEDIS detailing|"academic detailing to employees responsible for purchasing health care benefits on how to use HEDIS indicators for depression to assure their depressed employees receive high quality care for the condition
~technical assistance"
16249285|NCT01013207|Device|CPAP Pre Nexus (S9)|This is the patient's own CPAP prior to trialling the Nexus (S9). 4 weeks of data will be downloaded from this device and compared to 4 weeks using Nexus (S9), and 4 weeks usage post trialling Nexus (S9)
16249286|NCT01013207|Device|Nexus (S9)|The patient will use the new Nexus (S9) CPAP for four weeks in place of their usual CPAP every night when they sleep to treat their OSA. Compliance data will be compared between four weeks on this device to the last four weeks on their current device (CPAP Pre S9). After using the Nexus (S9) CPAP for four weeks, participants will return to their current device for four weeks. Data from this post-trial period will be compared with both the Nexus (S9) four weeks, and the four weeks pre Nexus (S9) usage.
16249287|NCT01013207|Device|CPAP Post Nexus (S9)|After trialling the Nexus (S9) for four weeks, patients will return to their usual CPAP. Data from the patient's usual CPAP for four weeks will be compared to data while using the Nexus (S9), and data from the patient's usual device pre trialling S9 (CPAP Pre Nexus)
16249333|NCT01012895|Drug|BMS-790052|Tablets, Oral, 60 mg, once daily, 24 weeks
16249334|NCT01012895|Drug|BMS-650032|Tablets, Oral, 600 mg, twice daily, 24 weeks
16249335|NCT01012895|Drug|BMS-650032|Tablets, Oral, 200mg, twice daily, 24 weeks
16249288|NCT01013194|Other|Human Fetal Liver Cell Transplantation|"Human Fetal Liver Cell Transplantation. Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
~Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.
~Cell infusion: between 5 and 10x10^8 cells. Number of sessions: up to 2."
16249289|NCT01013168|Procedure|Apheresis using the OncoSorb column|device is intended to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α)
16249290|NCT01013155|Drug|perindopril erbumine|8 mg tablet
16249291|NCT01013142|Drug|MN-221 (Dose Group 1)|i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour
16249292|NCT01013142|Drug|MN-221 (Dose Group 2)|i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour
16249293|NCT01013142|Drug|MN-221 (Dose Group 3)|i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
16249294|NCT01013129|Genetic|DNA analysis|saliva samples will be collected from men (probands) who join the study as well as from first degree relatives who join the study
16249295|NCT01013129|Genetic|polymorphism analysis|we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis
16249296|NCT01013129|Other|laboratory biomarker analysis|10ml blood specimen will be obtained and processed (on probands locally-consented and/or those who have an appointment at the VA in Portland, Oregon) to allow for analyses of erythrocyte fatty acids and future nutrient and DNA analyses
16249297|NCT01013129|Other|medical chart review|PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
16249298|NCT01013129|Other|questionnaire administration|probands are asked to complete questionnaires on 1) family history of cancer, 2) diet history over the past year, 3) employment environment and risk factors and/or 4) changes to diet, medications since enrollment in originating case control study
16249299|NCT01013129|Procedure|evaluation of cancer risk factors|pathology reports will be reviewed for probands whose prostate biopsies reveal cancer; these factors will be evaluated for cancer risk factors
16249300|NCT01013129|Procedure|study of high risk factors|prostate biopsy pathology reports will be reviewed for high risk factors
16249301|NCT01013116|Biological|modified allergen extract of house dust mites|subcutaneous injections
16249302|NCT01013116|Biological|placebo|subcutaneous injections
16249303|NCT01013103|Drug|Atorvastatin, high vs low dose|In this arm patients with ischemic heart disease will be recruited. In a double-blind crossover design heart failure patients (n=30) naïve to statins treatment will be randomized to receive oral atorvastatin 10mg/day 1x1(n=15) or oral atorvastatin 40mg/day 1x1 (n=15) for 4 weeks. At the end of 4 weeks a 2-week wash out period will follow and then all patients will switch atorvastatin dose and continue treatment for 4 weeks (e.g all patients that were under atorvastatin 10mg/day will be switched to atorvastatin 40mg/day and vice versa).
16249304|NCT01013103|Drug|Atorvastatin vs Placebo|In this arm, patients undergoing cardiac surgery (CABG, valve replacement or aortic surgery) that are not under statins treatment will be recruited. Patients will be randomized in a double-blind fashion to atorvastatin 40mg/day or placebo for 3 days before surgery date.
16249305|NCT01013090|Drug|Ringer's Lactate|Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
16249306|NCT01013090|Drug|Six percent hydroxyethyl starch|Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
16249307|NCT01013077|Drug|Optive|Use a minimum of 2 drops per day for 1 month.
16249308|NCT01013077|Drug|Soothe|Use a minimum of 2 drops per day for 1 month.
16249309|NCT01013077|Drug|New Emulsion|Use a minimum of 2 drops per day for 1 month.
16249310|NCT01013064|Drug|HM10760A or Placebo|0.04 mcg/kg to 2.0mcg/kg once intravenously
16249311|NCT01013038|Procedure|Thrombus aspiration followed by stent implantation|Export aspiration catheter 6F (Medtronics)
16249312|NCT01013038|Procedure|conventional PCI|balloon angioplasty and/or stent implantation
16249313|NCT01013025|Procedure|Ultrasound or CT or MRI to locate implant|Scanning methods (eg, ultrasound, CT, or MRI) were used to locate the implant.
16249314|NCT01013012|Drug|ramosetron with saline|Group A : saline 1 ml, ramosetron 6μg/kg
16249315|NCT01013012|Drug|ramosetron with dexamethasone|Group B : dexamethasone 4 mg, ramosetron 6μg/kg
16249316|NCT01012999|Drug|sufentanil|Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period
16249317|NCT01012986|Other|Assessment of reading skills|
16249318|NCT01012973|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.
16249319|NCT01012973|Other|Sham treatment|Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
16249320|NCT01012960|Drug|methylnaltrexone|0,15 mg/kg sc ( subcutaneously)once per volunteer
16249321|NCT01012947|Behavioral|Lifestyle Counseling Usual Care|Usual care participants in the group A received no additional services.
16249322|NCT01012947|Behavioral|Lifestyle Counseling Telephone, Bimonth|Participants in the group B received bimonthly telephonic care management based on manual.
16249323|NCT01012947|Behavioral|Lifestyle Counseling Telephone, Month|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
16249324|NCT01012947|Behavioral|Lifestyle Counseling Visit, Bimonth|Participants in the group D received health educator-initiated visit counseling bimonthly.
16249325|NCT01012947|Behavioral|Lifestyle Counseling Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
16249326|NCT01012934|Drug|Alendronate Sodium Tablets, 70 mg|1 x 70 mg, single-dose fasting
16249327|NCT01012934|Drug|Fosamax Tablets, 70 mg|1 x 70 mg, single-dose fasting
16249328|NCT01012921|Device|barrier membrane|The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
16249329|NCT01012921|Device|MembraGel|Device application at surgery
16249330|NCT01012921|Other|Bio-Gide® membrane|Device application at surgery
16249331|NCT01012908|Dietary Supplement|Norzyme - Bergamo|2 - 8 tablets per day.
16249332|NCT01012908|Dietary Supplement|Creon|2 - 8 tablets pet day
16249336|NCT01012895|Drug|BMS-650032|Tablets, Oral, 200 mg, once daily, 24 weeks
16249337|NCT01012895|Drug|Pegylated-interferon alfa-2a|Syringe, Subcutaneous Injection, 180 µg, once weekly
16249338|NCT01012895|Drug|Ribavirin|"Tablets, Oral
~For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg
~Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks"
16249339|NCT01012882|Biological|sublingual immunotherapy with allergen extract|sublingual application
16249340|NCT01012882|Biological|sublingual immunotherapy with placebo|sublingual application
16249341|NCT01012869|Device|everolimus-eluting stent|everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)
16249342|NCT01012856|Behavioral|Cognitive-Behavioral Therapy for Depression|22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions
16249343|NCT01012856|Behavioral|Exposure-Based Cognitive Therapy for Depression|22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions
16249344|NCT01012843|Drug|Amoxicillin-Clavulanate|oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days
16249345|NCT01012843|Drug|Placebo|oral Placebo tablets two times a day for 10 days
16249346|NCT01012830|Drug|Huperzine A|Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.
16249347|NCT01012817|Other|Laboratory Biomarker Analysis|Correlative studies
16249348|NCT01012817|Other|Pharmacogenomic Study|Correlative studies
16249349|NCT01012817|Other|Pharmacological Study|Correlative studies
16249350|NCT01012817|Drug|Topotecan Hydrochloride|Given IV
16249351|NCT01012817|Drug|Veliparib|Given PO
16249352|NCT01012804|Genetic|western blotting|
16249353|NCT01012804|Other|immunohistochemistry staining method|
16249354|NCT01012804|Other|laboratory biomarker analysis|
16249355|NCT01012791|Other|Zumba exercise|Subjects with do Zumba exercise for approximately 60 minutes twice a week for 6 months.
16249356|NCT01012778|Behavioral|Climb Up ADHD and Dyslexia Program|Using a peer mediated multimodal intervention program for ADHD and Dyslexia use Yoga, Meditation, Play therapy administered by (trained) high school volunteers
16249357|NCT01012765|Drug|Indacaterol|Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
16249358|NCT01012765|Drug|Tiotropium|Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
16249359|NCT01012765|Drug|Placebo|Placebo to indacaterol o.d. delivered via SDDPI
16249360|NCT01012752|Biological|modified allergen extract|subcutaneous injections
16249361|NCT01012752|Biological|Placebo|subcutaneous injections
16249362|NCT01012739|Drug|Indacaterol 150 μg via the Concept1 dry-powder inhaler|Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.
16249363|NCT01012739|Drug|Indacaterol 60 μg via the Simoon dry-powder inhaler|Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
16249364|NCT01012739|Drug|Indacaterol 120 μg via the Simoon dry-powder inhaler|Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
16249365|NCT01012739|Drug|Placebo to indacaterol via the Concept1 dry-powder inhaler|Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.
16249366|NCT01012726|Procedure|Colonoscopy|During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
16249367|NCT01012713|Drug|Clobex Spray|Clobex Spray BID for Weeks 1-4 and weeks 9-12
16249368|NCT01012713|Drug|Vectical Ointment|Vectical ointment BID for weeks 5-8 and 9-12
16249369|NCT01012713|Procedure|Excimer Laser|Laser treatment for weeks 1-6 study and as needed for patients with less than PASI-75 response thereafter.
16249370|NCT01012700|Drug|Hiltonol (poly ICLC)|2 mg administered subcutaneously or intranasally to healthy volunteers
16249371|NCT01012687|Drug|perindopril erbumine|8 mg tablet
16249372|NCT01012674|Drug|Dotarem|Each subject will receive one injection of Dotarem 0.2ml/kg
16249373|NCT01012674|Other|TOF MRA|Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)
16249374|NCT01012661|Device|Radiesse® Injectable Dermal Filler Mixed with Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
16249375|NCT01012661|Device|Radiesse® Injectable Dermal Filler without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
16249376|NCT01012648|Drug|Fluid resuscitation|Volume resuscitation
16249377|NCT01012648|Drug|HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution|Volume Resuscitation
16249378|NCT01012635|Other|Hypnosis|Hypnosis Training: Verbal suggestions from an audio recording (via headphones).
16249379|NCT01012635|Other|Meditation|"Meditation: focus on a single word (one) for the entire session."
16249380|NCT01012635|Other|Neurofeedback training|Neurofeedback Training: Two electrodes will be placed on your scalp, and one electrode clipped on your head. There is no risk of electrical shock.
16249381|NCT01012635|Other|Two different levels of tDCS|Direct stimulation of the brain by using a weak electrical current. There is no risk of electrical shock.
16249382|NCT01012622|Drug|Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride|OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
16249383|NCT01012609|Other|cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan|External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
16250075|NCT01007721|Drug|montelukast placebo tablet|1 over-encapsulated montelukast placebo tablet (qd in the morning)
16249384|NCT01012596|Behavioral|Creighton Model System of Natural Family Planning|Participants will learn the Creighton Model, a standardized method of natural family planning, from FertilityCare Practitioners from established FertilityCare Centers. The learning can be done in-person or long distance.
16249385|NCT01012570|Drug|Application of Adalimumab|Adalimumab will be applied according to manufacture's instruction and official guidelines.
16249386|NCT01012557|Biological|Focetria|7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular)x 1
16249387|NCT01012557|Biological|Focetria|3.75 mcg H1N1v half MF59 adjuvant i.m.(intramuscular)x 1
16249388|NCT01012557|Biological|Focetria|15 mcg N1N1v unadjuvanted i.m.(intramuscular) x 1.
16249389|NCT01012557|Biological|Focetria|7.5 mcg H1N1v full MF59 adjuvant i.m.(intramuscular) x 1
16249390|NCT01012544|Drug|Clopidogrel|both arms of the study (patients with a history of stent thrombosis as well as patients who did not suffer from a stent thrombosis) will be given a 600 mg loading dose of clopidogrel
16249391|NCT01012531|Biological|Subcutaneous injections with highly polymerized allergen extract|cluster schedule
16249392|NCT01012531|Biological|Subcutaneous injection with placebo|cluster schedule
16249393|NCT01012518|Device|Standard PCT|The standard technique, performed without video guidance
16249394|NCT01012518|Device|Video-guided PCT|PCT performed with the guidance of a camera-embedded ETT wired to a monitor
16249395|NCT01012505|Other|adding pad with maternal milk in hte incubator|"2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol.
~stopping intervention and for other 2 days recording infants data and taking saliva cortisol"
16249396|NCT01012492|Drug|Abatacept|Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.
16249397|NCT01012479|Drug|Candesartan cilexetil and hydrochlorothiazide|Candesartan cilexetil 16 mg, tablets, orally, once daily for 1 week; increased to candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg combination tablet, orally once daily for 2 weeks; then increased to candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for up to 6 weeks
16249398|NCT01012453|Behavioral|A randomised clinical trial of the effect of classification and individual counselling|The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group.
16249399|NCT01012440|Device|PEM Flex Solo II PET Scanner|Subjects will receive bilateral (both sides) breast and axillary PEM scans.
16249400|NCT01012440|Device|MRI scan|Subjects will receive bilateral (both sides) breast and axillary MRI scans.
16249401|NCT01012427|Procedure|percutaneous cryoablation|All patients will have percutaneous image guided core biopsies of the treatment site and CT or MR imaging at approximately 5-7 months following the cryoablation. They will have repeat imaging every 5-7 months for a period of two years, and if there is evidence of recurrence (ablation zone increase > 5 mm or increased enhancement 15 HU), then repeat biopsy will be obtained. Imaging follow-up past the two year point will be at the discretion of the patient's physicians.
16249402|NCT01012414|Drug|paricalcitol|2 mcg oral paricalcitol daily
16249403|NCT01012414|Drug|placebo|placebo
16249404|NCT01012401|Other|CHESS website for lung cancer patient + internet access if needed|The Comprehensive Health Enhancement Support System (CHESS), a non-commercial, home-based system created by clinical, communication, and decision scientists at the University of Wisconsin, is distinguished by its quality, depth, and ease of use. It employs data on user health status to help users monitor their condition, guide them to tailored information and social support, make and implement important health decisions, and learn coping skills. Our tests and clinical trials demonstrate that an ICCS such as CHESS can be widely accepted and used, improve quality of life, information competence, and in some cases lead to more efficient use of health services. An Internet-based system, CHESS-LC integrates over 14 services to provide tailored cancer information, support, interactive tools, and communication with the clinical team.
16249405|NCT01012388|Device|Radiesse® Injectable Dermal Filler|Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
16249406|NCT01012375|Drug|AZD1446|10 mg capsule, oral dose
16249407|NCT01012375|Drug|AZD1446|80 mg capsule, oral dose
16249408|NCT01012375|Drug|AZD1446|80 mg capsule, oral dose
16249409|NCT01012375|Drug|Placebo|Matching capsule, oral dose
16249410|NCT01012362|Drug|Pazopanib|Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
16249411|NCT01012362|Drug|Ixabepilone|Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle
16249412|NCT01012349|Drug|Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)|1 tablet in an episody of headache
16249413|NCT01012349|Drug|Aspirin - Bayer|1 tablet in an episody of headache (Aspirin 500mg)
16249414|NCT01012336|Drug|Aprepitant/Ramosetron/Dexamethasone|"Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3.
~Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy.
~Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg."
16249415|NCT01012323|Biological|NewGam|The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as minimum trough levels of serum immunoglobulin G (IgG) was above 5 g/L. If serum IgG trough levels dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
16251887|NCT00994500|Drug|vorinostat|Given orally
16249416|NCT01012310|Drug|PF-04531083 or Placebo|Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
16249417|NCT01012310|Drug|PF-04531083 or Placebo|Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
16249418|NCT01012310|Drug|PF-04531083 or Placebo|Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
16249419|NCT01012310|Drug|PF-04531083 or Placebo|A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
16249420|NCT01012297|Biological|Bevacizumab|Given IV
16249421|NCT01012297|Drug|Docetaxel|Given IV
16249422|NCT01012297|Biological|Filgrastim|Given SC
16249423|NCT01012297|Drug|Gemcitabine Hydrochloride|Given IV
16249424|NCT01012297|Biological|Pegfilgrastim|Given SC
16249425|NCT01012297|Other|Placebo|Given IV
16249426|NCT01012284|Drug|TMC207|400 mg (4 tablets of 100 mg) of TMC207 will be administered as a single dose on Day 1 of the treatment period to participants of both the Panels (Panel A and Panel B)
16249427|NCT01012271|Other|MRI|MR arthrography is used to evaluate wrist abnormalities
16249428|NCT01012258|Biological|Cetuximab + concomitant boost radiotherapy|"Cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially
~Once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by
~Twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses are separated by at least a 6-hour interval"
16249429|NCT01012245|Other|no intervention|
16249430|NCT01012232|Drug|20 mL ropivacaine 5 mg/mL|
16249431|NCT01012232|Drug|10 mL ropivacaine 10 mg/mL|
16249432|NCT01012219|Drug|niacin (+) laropiprant|open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
16249433|NCT01012219|Drug|Comparator: aspirin|81 mg oral tablet once daily for 7 days
16249434|NCT01012219|Drug|Comparator: clopidogrel|75 mg oral tablet once daily for 7 days
16249435|NCT01012219|Drug|Comparator: laropiprant|40 mg oral tablet once daily for 7 days
16249436|NCT01012219|Drug|Comparator: placebo|placebo oral tablet once daily for 7 days
16249437|NCT01012206|Behavioral|Intervention regarding food habits and physical activity.|Children in the intervention group participated in an intervention program regarding food habits and physical activity.
16249438|NCT01012193|Drug|cilostazol 100mg bid or clopidogrel 150-mg daily|Adjunctive cilostazol: cilostazol 100-mg bid +clopidogrel 75mg daily+aspirin 200mg daily High-MD clopidogrel: clopidogrel 150mg daly +aspirin 200mg daily
16249439|NCT01012167|Drug|Oxytocin|Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration
16249440|NCT01012167|Drug|Galantamine|Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks
16249441|NCT01012167|Other|Placebo-Oxytocin|Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration
16249442|NCT01012167|Other|Placebo-Galantamine|Placebo tablets twice a day for 6 weeks
16249443|NCT01012154|Device|Endomicroscope|Endomicroscopic images and biopsies are taken at several positions on the tumor.
16249444|NCT01012141|Dietary Supplement|phytochemical|
16249445|NCT01012141|Drug|Docetaxel|
16249446|NCT01012102|Biological|EMD 640744|EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
16249447|NCT01012102|Biological|EMD 640744|EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
16249448|NCT01012102|Biological|EMD 640744|EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
16249449|NCT01012102|Other|Montanide ISA 51 VG|Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
16249450|NCT01012102|Other|Montanide ISA 51 VG|Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
16249451|NCT01012102|Other|Montanide ISA 51 VG|Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)
16249452|NCT01012089|Drug|Daptomycin|Daptomycin IV 5 mg/kg one time dose
16249453|NCT01012076|Behavioral|Active Control vs Experimental Treatment|The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005). The active control involves three 90 minute in-home training sessions. These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field. The active control will follow a standardized treatment manual (Kasari, 2008). This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
16249454|NCT01012063|Drug|iron sucrose, erythropoietin-β|The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.
16249455|NCT01012063|Drug|normal saline|100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
16249456|NCT01012050|Device|NV|Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)
16249457|NCT01012050|Other|NEB group|Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
16249458|NCT01012037|Drug|linagliptin low dose|patient to receive tablets containing low dose linagliptin twice daily
16249459|NCT01012037|Drug|placebo|patient to receive placebo tablet(s) matching linagliptin
16249460|NCT01012037|Drug|linagliptin medium dose|patient to receive a tablet containing medium dose linagliptin once daily
16249461|NCT01012011|Drug|Sorafenib (Nexavar, BAY43-9006)|Daily dose, dosage frequency and duration will be decided by physicians.
16249462|NCT01011998|Drug|Gleevec (imatinib), valproic acid|"Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level.
~Gleevec will be continued at the dose the patient was taking at the time of entry onto the study."
16249463|NCT01011972|Drug|XMT-1107|6 mg XMT-1107 administered by I.V. (in the vein) administered over 90 min, once every 21 days : until progression or unacceptable toxicity develops
16249464|NCT01011959|Biological|REGN88|This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
16249465|NCT01011946|Device|Positron Emission Mammography|Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
16249466|NCT01011933|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16249467|NCT01011933|Drug|Selumetinib|Given PO
16249468|NCT01011920|Drug|Methotrexate|Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
16249469|NCT01011920|Drug|Ara-C|Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
16249470|NCT01011920|Drug|Rituximab|Rituximab 375 mg/m2 conventional infusion on day - 5 & 0 every 3 weeks for a maximum of 4 cycles
16249471|NCT01011920|Drug|Thiotepa|ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 & -4
16249472|NCT01011920|Radiation|radiotherapy|Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
16249473|NCT01011920|Drug|BCNU|BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
16249474|NCT01011920|Other|APBSCT|Autologous peripheral blood stem cell transplant (APBSCT)
16249475|NCT01011907|Drug|varenicline|12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
16249476|NCT01011907|Drug|placebo|12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
16249477|NCT01011894|Drug|lenalidomide|Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg.
16249478|NCT01011881|Other|pleural level of procalcitonin|no intervention
16249479|NCT01011868|Drug|BI 10773 placebo|BI 10773 placebo
16249480|NCT01011868|Drug|BI 10773 low dose|BI 10773 low dose
16249481|NCT01011868|Drug|BI 10773 high dose|BI 10773 high dose
16249482|NCT01011868|Drug|BI 10773 placebo|BI 10773 placebo
16249483|NCT01011855|Device|GEHC IWS 4400 & Giraffe Warmer beds|Clinical care provided first on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with a proportional heater control algorithm.
16249484|NCT01011855|Device|GEHC IWS 4400 & Giraffe Warmer beds|Clinical care provided first on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm.
16249485|NCT01011855|Device|GEHC IWS 4400 & Giraffe Warmer beds|Clinical care is first provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm.
16249486|NCT01011855|Device|GEHC IWS 4400 & Giraffe Warmer beds|Clinical care is first provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm.
16249487|NCT01011855|Device|GEHC IWS 4400 & Giraffe warmer beds|Clinical care is first provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm.
16249488|NCT01011855|Device|GEHC IWS 4400 & Giraffe Warmer beds|Clinical care is first provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm.
16249489|NCT01011842|Procedure|Radiotherapy|Standard of care
16249490|NCT01011842|Procedure|Align RT|Standard of care
16249491|NCT01011829|Drug|Varenicline|Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
16249492|NCT01011829|Drug|Placebo|Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
16249493|NCT01011816|Biological|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
16249494|NCT01011816|Drug|Saline|One injection of up to 4 mL of saline using the Biostat Delivery Device
16250076|NCT01007721|Drug|montelukast placebo tablet|1 over-encapsulated montelukast placebo tablet (qd in the morning)
16249495|NCT01011803|Other|Combined speech therapy tools, measures of swallowing function|All subjects will be assessed using combined speech therapy tools and ordinal measures of swallowing function. The combined speech therapy tools were [diadochokinesis, glottal coup, and the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)]. The ordinal measures of swallowing function included Dysphagia Admission Screening Tool (DAST), Modified Barium Swallow (MBS), and Fiberoptic Endoscopic Evaluation of the Swallow (FEES).
16249496|NCT01011790|Behavioral|Healing Rhythms™ Meditation Program|The Healing Rhythms™ meditation program was chosen as the intervention for this study because it has a long history of use in the consumer market, it provides a dual-mode biofeedback which allows users to visually see their progress, and it provides an attractive and engaging user interface which is enjoyable to use. This is a critical factor as the research cited documents the importance of adherence in achieving optimal outcomes.
16249497|NCT01011777|Drug|MDC|After the biopsy the MDC expansion process takes approximately 21 days after which cells are harvested and cryopreserved for future injection. The MDC product is stored in single use vials, with each vial containing approximately 2.6 x 10^7 total cells. The volume of each vial will be 1.3ml. This study uses a single dose of approximately 2.0 x 10^7 cells administered endoscopically into the external urethral sphincter in 12 injections of 0.1ml each. Six months post-initial MDC injection, group 1 participants with persistent bladder capacity less than 100cc and group 2 participants with persistent urinary incontinence as defined in eligibility criteria may undergo repeat injections of MDC at 6 month intervals for up to a total of 4 injections.
16249498|NCT01011764|Behavioral|SKILLS vs ENGAGE|The investigators plan to contrast 2 different models for social skills groups. Each model involves 16 45-minute bi-weekly sessions, twice a week with a small group of children with ASD. Details of the 2 intervention models are described below.
16249499|NCT01011751|Drug|Cyproterone acetate|Cyproterone acetate tablet-in-capsule.
16249500|NCT01011751|Drug|Medroxyprogesterone acetate|Medroxyprogesterone acetate tablet-in-capsule.
16249501|NCT01011751|Drug|Venlafaxine|Venlafaxine capsule.
16249502|NCT01011751|Drug|Leuprorelin|Leuprorelin injection.
16249503|NCT01011751|Drug|Flutamide|Flutamide tablet
16249504|NCT01011751|Drug|Placebo|Cyproterone acetate, medroxyprogesterone acetate or venlafaxine placebo-matching capsule.
16249505|NCT01011725|Drug|MK 0773|25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
16249506|NCT01011725|Drug|Placebo|Placebo oral tablet b.i.d for 12 weeks
16249507|NCT01011699|Drug|nicotinamide|"Titration phase of nicotinamide (Nicobion) with the aim of phosphatemia control in 4 weeks with stable dose of calcic carbonate;
~Increase of nicotinamide dose of Nicobion 500mg (nicotinamide 500mg), up to 4 tablets daily, as follows:
~0 morning, 1 noon, 0 evening (first week), then, 0 morning, 1 noon, 1 evening (second week), then, 1 morning, 1 noon, 1 evening (third week), then, 1 morning, 2 noon, 1 evening (fourth week)."
16249508|NCT01011699|Drug|sevelamer|"Titration phase with sevelamer (Renagel) with the aim of phosphatemia control before 4 weeks of treatment, with stable dose of calcic carbonate.
~Increase of sevelamer dose up to 12 tablets, as follows:
~0 morning, 2 noon, 2 evening (first week), then, 0 morning, 4 noon, 4 evening (second week), then, 2 morning, 4 noon, 4 evening (third week), then, 4 morning, 4 noon, 4 evening (fourth week)."
16249509|NCT01011699|Drug|cinacalcet|"After 6 months of treatment, patient screening on PTH level:
~For patients with PTH > 300pg/ml, introduction of cinacalcet by level of 30 mg every 3 weeks, up to 180mg daily (administered during the meal and before next dialysis) Cinacalcet increase will be stopped once PTH < 250 pg/ml. Calcic carbonate dose will be increase once calcemia will be < 2.25 mmol/l. If maximum tolerated dose is not sufficient to prevent hypocalcemia < 2.10 mmol/l calcium of dialysis bath wille be increased up to 1.75 mmol/l and calcic carbonate will be decreased.
~A dose adjustment is possible with nicotinamide to obtain a phosphatemia between 1.10 and 1.60 mmol/l."
16249510|NCT01011686|Biological|ANT-SM|autologous adipose-derived stem cell
16249511|NCT01011673|Drug|Metoclopramide|metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
16249512|NCT01011673|Drug|Ketorolac|ketorolac 30mg IVSS
16249513|NCT01011660|Drug|Amlodipine, Telmisartan, Amiloride Compound , Simvastatin|Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
16249514|NCT01011634|Drug|Intravenous moderate sedation versus oral medication|Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)
16249515|NCT01011621|Drug|0.5% prednisolone acetate cream|Small amount applied over the lesion twice a day for 14 days.
16249516|NCT01011621|Drug|0.1% betamethasone valerate cream|Small amount applied over the lesion twice a day for 14 days.
16249517|NCT01011608|Other|Medical Food Supplement|Medical Food Supplement to be given in divided portions in morning, afternoon and evening
16249518|NCT01011608|Other|standard hospital food|standard hospital diet ad. lib.
16249519|NCT01011595|Procedure|Cervical Mediastinoscopy|Surgical Meciastinal Lymph Node Staging
16249520|NCT01011595|Procedure|Endobronchial Ultrasound (EBUS)|Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy
16249521|NCT01011595|Procedure|Endoscopic Ultrasound (EUS)|Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy
16249522|NCT01011556|Drug|Subcutaneous Teriparatide|Administered subcutaneously once daily for 12 months
16249523|NCT01011556|Drug|Transdermal Teriparatide|Administered transdermally, applied once daily for 6 hours over 12 months
16249524|NCT01011543|Procedure|Diagnostic techniques in pulmonary tuberculosis|Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
16249525|NCT01011530|Drug|MLN4924|Patients will be administered MLN4924 via an IV infusion. Each 21-day treatment cycle is composed of 2 weeks intermittent dosing of MLN4924 on Days 1, 4, 8 and 11, followed by a rest period of 10 days. A cohort of patients will receive a reduced first dose on Day 1, approximately half the strength of the dose received on Days 4, 8, 11 and dose will not be administered on Day 4 if the Day 1 dose is not tolerated.(Schedule A ramp-up), or continuous weekly dosing (Days 1, 8, and 15) of MLN4924 (Schedule B)
16249526|NCT01011517|Dietary Supplement|Muscadine grape seed supplement|Nature's Pearl 650 mg, two capsules daily
16249656|NCT01010620|Behavioral|Various Screening psychiatric and medical assessments|Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.
16249527|NCT01011491|Other|Medifast 5 & 1 Plan for weight loss and weight maintenance|Medifast's 5 & 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups.
16249528|NCT01011491|Other|Food-based diet plan for weight loss and weight maintenance|The food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 & 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid.
16249529|NCT01011478|Drug|rosuvastatin|
16249530|NCT01011478|Other|placebo|
16249531|NCT01011465|Drug|intranasal oxytocin|The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after 24 IUs of oxytocin have been administered. Duration of administration is anticipated to be 2-5 minutes
16249532|NCT01011465|Drug|Placebo|Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after the full amount in the spray bottle has been used. Duration of administration is anticipated to be 2-5 minutes
16249533|NCT01011465|Behavioral|Social support|Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. If instructed to bring a same-sex close friend (excluding spouses, participants are joined by their support partners join participants at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
16249534|NCT01011465|Behavioral|No Social Support|Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. They are then instructed to bring a same-sex close friend (excluding spouses) with them, or to come alone. If they come to the laboratory without a friend, they engage in all the laboratory procedures without a friend present.
16249535|NCT01011452|Drug|Montelukast|1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
16249536|NCT01011452|Drug|Placebo|1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
16249537|NCT01011439|Drug|Milciclib Maleate|"150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
~Number of cycles: until disease progression or unacceptable toxicity."
16249538|NCT01011426|Drug|Bisacodyl|5mg po 6 hours postoperatively, repeat in 12 hours if no flatus
16249539|NCT01011426|Drug|placebo|1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus
16249540|NCT01011413|Drug|Efavirenz 600mg|3 x EFV 200 milligram (mg) tablets once daily
16249541|NCT01011413|Drug|Efavirenz 400mg|2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily
16249542|NCT01011387|Procedure|NPWT System|Dressing change 3 times per week
16249543|NCT01011387|Device|NPWT system|3 dressing changes/week for maximum 4 weeks.
16249544|NCT01011374|Drug|ranibizumab (Lucentis)|0.5 mg, administered intravitreally every 4 weeks
16249545|NCT01011348|Dietary Supplement|Coenzyme Q10|100mg/day for three months
16249546|NCT01011348|Dietary Supplement|Coenzyme Q10|300mg/day for three months
16249547|NCT01011348|Dietary Supplement|Placebo|Three month period
16249548|NCT01011335|Biological|Monovalent rAT|10, 25, 50 or 100 μg
16249549|NCT01011335|Biological|Monovalent rLukS-PV|10, 25, 50 or 100 μg
16249550|NCT01011335|Biological|Bivalent rLukS-PV / rAT|10, 25 or 50 μg
16249551|NCT01011335|Biological|Placebo with adjuvant|Placebo with adjuvant
16249552|NCT01011335|Biological|Placebo|Placebo saline
16249553|NCT01011322|Drug|LT-02|Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
16249554|NCT01011322|Drug|placebo|placebo
16249555|NCT01011309|Biological|LEISH-F2 + MPL-SE|10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
16249556|NCT01011309|Drug|Sodium stibogluconate|20 mg/kg/day IV daily for 20 days
16249557|NCT01011296|Drug|PF-04427429|Single 0.2mg dose of intravenous infusion
16249558|NCT01011296|Drug|PF-04427429|Single 1mg dose of intravenous infusion
16249559|NCT01011296|Drug|PF-04427429|Single 3 mg dose of intravenous infusion
16249560|NCT01011283|Drug|decitabine|decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
16249561|NCT01011283|Drug|azacitidine|azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
16249562|NCT01011257|Drug|Asprin|asprin 81mg, 1 tab, twice daily OR aspirin 81mg, 2 tab, once daily
16249563|NCT01011257|Drug|Clopidogrel|clopidogrel 75 mg bid
16249564|NCT01011244|Biological|ADIPOPLUS|"autologous cultured adipose-derived stem cells
~1x10e7 cells/1cm2 depending on surface area of fistula"
16249565|NCT01011231|Procedure|Gamma Knife Radiosurgery|Patient treatments will be planned with the Gamma Plan software. The dose will be prescribed to the isodose surface which encompasses the target volume within a range of 50-60% based on a local maximum of 100%. Radiosurgery dose will be prescribed based on volume within the prescribed isodose surface (not to exceed 18 cc)
16249566|NCT01011218|Behavioral|BBT-I|Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
16249567|NCT01011218|Behavioral|Control|Control behavioral intervention is a sleep hygiene handout completed by participant.
16249568|NCT01011218|Drug|Armodafinil|150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
16249569|NCT01011205|Drug|Advagraf|Capsule
16249570|NCT01011205|Drug|Mycophenolate Mofetil|Solution for infusion
16249571|NCT01011205|Drug|Basiliximab|IV infusion
16249572|NCT01011205|Drug|Corticosteroids|IV bolus
16249738|NCT01010061|Drug|chlorambucil|Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
16249573|NCT01011179|Behavioral|Teens Taking Charge|The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
16249574|NCT01011179|Behavioral|Self-Management|"Adolescents' own best efforts at managing their JIA"
16249575|NCT01011166|Drug|IDX184|IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
16249576|NCT01011166|Drug|Placebo|Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
16249577|NCT01011166|Biological|Peginterferon alfa-2a (Peg-IFN)|Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
16249578|NCT01011166|Drug|Ribavirin (RBV)|RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
16249579|NCT01011140|Behavioral|Survey|10-15 minute online survey to assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.
16249580|NCT01011127|Drug|pravastatin, rosuvastatin|
16249581|NCT01011114|Drug|Cinacalcet|cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
16249582|NCT01011114|Drug|Placebo|cinacalcet, 30 mg daily, titrated to achieve serum phosphorus of 2.5 mg/dl, versus placebo, similarly titrated.
16249583|NCT01011075|Drug|Imatinib mesylate|Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
16249584|NCT01011075|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6
16249585|NCT01011062|Procedure|Hyperinsulinaemia|Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
16249586|NCT01011062|Drug|Losartan|Acute administration of losartan 200mg total prior to clamp
16249587|NCT01011062|Drug|Saline|Infusion of Saline as a volume control intervention
16249588|NCT01011049|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16249589|NCT01011049|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16249590|NCT01011049|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16249591|NCT01011049|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16249592|NCT01011036|Drug|clobazam|test substance
16249593|NCT01011036|Drug|clonazepam|positive control
16249594|NCT01011036|Drug|tolterodine|active placebo
16249595|NCT01011023|Other|Non application of nasogastric tube in the experimental group|Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube
16249596|NCT01011010|Drug|doxorubicin hydrochloride|"TACE (day 18-20): Doxorubicin 50mg and mitomycin C 10mg mixed with lipoidal and injected in proportion to liver volume being treated, followed by embospheres. Administered until there is a pruned tree appearance on angiography. If a second TACE is to be performed it should be performed within 8 weeks of the first procedure."
16249597|NCT01011010|Drug|mitomycin C|"TACE (day 18-20): Doxorubicin 50mg and mitomycin C 10mg mixed with lipoidal and injected in proportion to liver volume being treated, followed by embospheres. Administered until there is a pruned tree appearance on angiography. If a second TACE is to be performed it should be performed within 8 weeks of the first procedure."
16249598|NCT01011010|Drug|sorafenib tosylate|Sorafenib 400mg BID continuously post TACE beginning when LFTs return to entry criterion. Discontinue at time of disease progression (progression in a lobe that has already been embolized, new lesions in an untreated lobe, or evidence of extrahepatic progression).
16249599|NCT01011010|Other|laboratory biomarker analysis|Serum VEGF levels are required: pre TACE (day of procedure, time B), 24 hours post TACE (+/- 6 hours, time C), day 7 post first TACE (± 1 day, time D), day 28 post reinitiation of sorafenib (± 3 days, time E). These levels will not be repeated for patients receiving a second TACE procedure.
16249600|NCT01011010|Other|pharmacological study|Treatment with sorafenib will continue on a daily basis until disease progression (see definition protocol Section 7) or unacceptable toxicity is encountered. At the end of treatment, no further therapies are currently recommended.
16249601|NCT01010997|Device|Foresee Home|using the Foresee home device
16249602|NCT01010984|Device|LC beads loaded with Doxorubicin|During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg
16249603|NCT01010971|Drug|Ciclesonide HFA 160 μg|Ciclesonide HFA Nasal Aerosol 160 μg once daily
16249604|NCT01010971|Drug|Ciclesonide HFA 80 μg|Ciclesonide HFA Nasal Aerosol 80 μg once daily
16249605|NCT01010971|Drug|Placebo|Placebo HFA Nasal Aerosol once daily
16249606|NCT01010958|Drug|Valproic Acid|Subjects should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 - 100 µg/mL).
16249607|NCT01010945|Drug|erlotinib|administered orally
16249608|NCT01010945|Drug|gemcitabine|administered intravenously
16249609|NCT01010945|Drug|nab-paclitaxel|administered intravenously
16249610|NCT01010932|Drug|Dotarem|Each subject will receive one injection of Dotarem 0.2ml/kg
16249611|NCT01010932|Other|TOF MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)
16249612|NCT01010919|Dietary Supplement|Chicory root extract|
16249613|NCT01010906|Drug|Vaniprevir 300 mg|single dose administration of 300 mg oral tablet
16249614|NCT01010906|Drug|Vaniprevir 200 mg|single dose administration of 200 mg oral tablet
16249739|NCT01010048|Drug|progesterone,tamsulosin,propantheline Bromide and nifedipine|clearance rate of stone
16249741|NCT01010022|Drug|6% hydroxyethyl starch 130/0.4|Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
16249615|NCT01010893|Biological|Vaccination with Fluval P and Fluval AB influenza vaccines|Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
16249616|NCT01010893|Biological|Vaccination with Fluval P monovalent influenza vaccine|Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant
16249617|NCT01010880|Drug|BKT140|BKT-140 drug substance is a highly selective CXCR4 antagonist. BKT140 will be injected S.C once at dose of 0.03, 0.1, 0.3, 0.9 mg/kg
16249618|NCT01010867|Drug|Lactobacillus plantarum strains 299 and 299v|"Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.
~Colony forming units (CFU)"
16249619|NCT01010854|Drug|VPA FEC100|oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
16249620|NCT01010841|Dietary Supplement|UltraMealPlus 360 (Medical food)|Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
16249621|NCT01010841|Other|Low-glycemic-load diet|Modified Mediterranean-style low-glycemic-load diet
16249622|NCT01010828|Procedure|Incision technique|Tri-Vector Approach retains the majority of 3 vectors of quadriceps.
16249623|NCT01010828|Procedure|Incision technique|Mini Mid-Vastus Approach
16249624|NCT01010815|Procedure|Colonoscopy biopsy|Colonoscopy biopsy will be performed in rectum, ascending and descending colon at study entry
16249625|NCT01010815|Other|stool collection|Stool will be collected from participants at study entry
16249626|NCT01010815|Procedure|colonoscopy biopsy|colonoscopy biopsy will be conducted in rectum, ascending and descending colon from participants 2 times during study - at active phase and inactive phase
16249627|NCT01010815|Other|stool collection|stool will be collected from participants 2 times during study - at active phase and inactive phase
16249628|NCT01010802|Drug|Erythropoietin human recombinant (EPOrh)|Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks
16249629|NCT01010789|Drug|Armodafinil|flexible dose 150-250mg/day
16249630|NCT01010789|Drug|Armodafinil|150-250mg/day; flexible dose
16249631|NCT01010789|Drug|Matching placebo|Placebo comparator
16249632|NCT01010776|Drug|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
16249633|NCT01010763|Device|Total Hip Arthroplasty|Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
16249634|NCT01010750|Drug|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
16249635|NCT01010750|Drug|Immediate Release Mixed Amphetamine Salts (MAS-IR)|Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
16249636|NCT01010750|Drug|LDX Placebo + MAS-IR Placebo|Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
16249637|NCT01010737|Biological|Multimeric-001 250 mcg|Multimeric-001 (M-001) was administered twice at a dose of 250mcg via the IM route to 10 participants as a primer, followed by TIV boost immunization. in 19-23 days interval between them.
16249638|NCT01010737|Biological|Adjuvanted Multimeric-001 250mcg|Injection of Multimeric-001 250 mcg with Adjuvant Montonide isa 51 VG, 2 doses with interval of 19-23 days between them
16249639|NCT01010737|Biological|Placebo|Placebo injected with PBS (Phosphate Buffered Saline), 2 injections with the interval of 19-23 days between them.
16249640|NCT01010737|Biological|Adjuvant: Montonide isa 51 VG|Injection of Placebo with Adjuvant Montonide isa 51 VG, 2 injections with the interval of 19-23 days between them.
16249641|NCT01010737|Biological|Multimeric-001 500 mcg|Injection of Multimeric-001 with PBS, 2 injections with the interval of 19-23 days between them.
16249642|NCT01010737|Biological|Adjuvanted Multimeric-001 500mcg|Injection of Multimeric-001 500 mcg with Adjuvant Montonide isa 51 VG, 2 doses with the interval of 19-23 days between them
16249643|NCT01010737|Biological|TIV|Injection of the conventional flu vaccine: Vaxigrip to all study participants.
16249644|NCT01010724|Drug|bIAP|
16249645|NCT01010724|Drug|Placebo|
16249646|NCT01010711|Dietary Supplement|Migra 3|powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements
16249647|NCT01010698|Drug|cimetidine (or acyclovir)|cimetidine (or acyclovir) 200mg (single dose)
16249648|NCT01010685|Procedure|Recovery of gallbladder via gastrotomy instead of via the skin|The gallbladder is dissected as for a standard laparoscopic cholecystectomy but is then recovered via a hole in the stomach created and closed endoscopically rather than through the skin as in the standard fashion
16249649|NCT01010672|Drug|Ridaforolimus|Ridaforolimus, oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week. Participants treated until discontinuation criteria, such as progressive disease or unacceptable toxicity, were met.
16249650|NCT01010659|Device|Lacrimal Tube|Lacrimal Tube
16249651|NCT01010646|Drug|IFN alfa-2b XL 27 MUI + Ribavirin|IFN alfa-2b XL 27 MUI administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses
16249652|NCT01010646|Drug|IFN alfa-2b XL 36 MUI + Ribavirin|IFN alfa-2b XL 36 MUI administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses
16249653|NCT01010646|Drug|IFN peg alfa-2b 1.5 µg/kg + Ribavirin|IFN peg alfa-2b 1.5 µg/kg administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses
16249654|NCT01010633|Drug|Vehicle of Loteprednol Etabonate|1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
16249655|NCT01010633|Drug|Loteprednol Etabonate|1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
16249657|NCT01010607|Device|Vibration and Mirror|10 treatments of 30 minutes in which vibration of 50-100 Hz will be administrated to the elbow and wrist muscles together with the use of a mirror. The patient moves his healthy hand in a certain repetitive pattern and watches its reflection on a mirror. Meanwhile he receives vibration in his affected hand in a timing that induces the illusion of movements similar to the movements of his healthy hand, thereby inducing a strong illusion of movement of his affected hand.
16249658|NCT01010607|Device|Mirror therapy|10 sessions of mirror therapy: moving the healthy hand while watching its reflection on a mirror. Meanwhile sham vibration over bone in the affected handwill be given to resemble the conditions of the experimental arm.
16249659|NCT01010607|Device|no mirror, sham vibration|10 sessions in which patient moves his healthy hand and tries to move his affected hand, which is hidden by an opaque board instead of a mirror. Sham vibration is applied to bone instead of muscle, no illusion is generated.
16249660|NCT01010594|Behavioral|dietary treatment|A standard dietary treatment except that they are advised to restrict their fruit intake.
16249661|NCT01010594|Behavioral|dietary treatment|A standard dietary treatment.
16249662|NCT01010581|Drug|SC12267 (4SC-101)|oral administration
16249663|NCT01010581|Drug|Placebo|oral administration
16249664|NCT01010581|Drug|Methotrexate|oral administration
16249665|NCT01010581|Drug|Folic Acid|oral administration
16249666|NCT01010568|Drug|Ofatumumab and Bendamustine|Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
16249667|NCT01010555|Device|lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens
16249668|NCT01010555|Device|balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens
16249669|NCT01010555|Device|senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens
16249670|NCT01010555|Device|enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens
16249671|NCT01010542|Drug|ILV-095 300 mg in a 4 to 1 ratio|Single dose of ILV-095 300 mg
16249672|NCT01010542|Drug|ILV-095 300 mg in a 4 to 1 ratio|Single dose of Placebo
16249673|NCT01010529|Other|occupational therapy|Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.
16249674|NCT01010516|Drug|High-dose rosuvastatin|40 of rosuvastatin daily
16249675|NCT01010516|Drug|Statin plus fenofibrate|Existing statin plus micronised fenofibrate 200 mg daily
16249676|NCT01010516|Drug|Statin plus niacin ER/laropiprant|Existing statin plus extended-release niacin/laropiprant (1 g/day for the first month which will be uptitrated to 2 g/day for the next months)
16249677|NCT01010503|Drug|tocilizumab [RoActemra/Actemra]|tocilizumab 8 mg/kg intravenous infusion once in 4 weeks
16249678|NCT01010490|Procedure|Torsional ultrasound (INFINITI, Alcon, USA)|Comparison of inta-operative efficacy and safety
16249679|NCT01010490|Procedure|Longitudinal U/S (Infiniti system, Alcon, USA)|comparison of efficacy and safety
16249680|NCT01010490|Procedure|Longitudinal U/S (LEGACY 20000, Alcon, USA)|Interrupted energy modality
16249681|NCT01010477|Drug|Nicotine Nasal Spray|minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
16249682|NCT01010477|Behavioral|Behavioral counseling|Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
16249683|NCT01010464|Procedure|Adhesion Reduction Plan|Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane
16249684|NCT01010451|Procedure|Antimicrobial pulpotomy|Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.
16249685|NCT01010451|Procedure|Calcium hydroxide pulpectomy|Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication
16249686|NCT01010425|Drug|ACP-001 (TransCon PEG hGH)|ACP-001, dose-level 1, s.c., single-dose
16249687|NCT01010425|Drug|ACP-001 (TransCon PEG hGH)|ACP-001, dose-level 2, s.c., single-dose
16249688|NCT01010425|Drug|ACP-001 (TransCon PEG hGH)|ACP-001, dose-level 3, s.c., single-dose
16249689|NCT01010425|Drug|ACP-001 (TransCon PEG hGH)|ACP-001, dose-level 4, s.c., single-dose
16249690|NCT01010425|Drug|Placebo|Placebo, s.c., single-dose
16249691|NCT01010425|Drug|Human Growth Hormone|Human Growth Hormone, s.c., daily for 7 days
16249692|NCT01010412|Device|Ultrasound (Sonosite Titan T-shaped ultrasound probe)|Ultrasonography will allow direct visualization of nerves. As local anesthetic is injected, it can be seen surrounding the nerve.
16249693|NCT01010412|Device|Electrical Nerve Stimulation (Stimuplex (B Braun) needle)|
16249694|NCT01010399|Dietary Supplement|Lovaza|Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks
16249695|NCT01010399|Drug|fosamprenavir/ritonavir|Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day
16249696|NCT01010386|Procedure|Atmospheric oxygen tension|Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
16249697|NCT01010386|Procedure|Physiologic oxygen tension|Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
16249698|NCT01010373|Drug|AS101|3 mg/m2 AS101 will be given intravenously (IV) three times per week.
16249699|NCT01010347|Procedure|Volar Splint|A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.
16249700|NCT01010347|Procedure|Cast|A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.
16249740|NCT01010035|Other|Plasma kinetic study|this study is done with the injection of LDL-like nanoemulsion doubly labeled with 14C- cholesteryl oleate and 3H- cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood sample collected in a pre established period of time in 24 hours.
16250077|NCT01007721|Drug|montelukast placebo tablet|1 over-encapsulated montelukast placebo tablet (qd in the morning)
16249701|NCT01010334|Other|standard of care|All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician.
16249702|NCT01010321|Device|confocal microscopy|non-invasive imaging
16249703|NCT01010308|Drug|Nadolol|Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.
16249704|NCT01010295|Drug|doxycycline (tetracycline)|doxycycline 100 mg twice daily for 3 weeks
16249705|NCT01010282|Drug|Glycerin and Polysorbate 80 based artificial tear|1-2 drops in each eye, as needed, but at least twice daily
16249706|NCT01010282|Drug|Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear|1-2 drops in each eye, as needed, but at least twice daily
16249707|NCT01010282|Drug|Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear|1-2 drops in each eye, as needed, but at least twice daily
16249708|NCT01010269|Device|Vanguard Complete Knee|Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
16249709|NCT01010269|Device|Vanguard High Flex RP|Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.
16249710|NCT01010243|Drug|Lenalidomide, Pioglitazone, dexamethasone, treosulfan|"Phase I:lenalidomide dose ( 5 mg or 10 mg or 15 mg) will be determined for phase II on the basis of DLTs in the first 4 weeks for the phase II part.
~Start Phase I part: lenalidomide 10 mg p.o. daily + pioglitazone 60 mg p.o. daily + treosulfan 250 mg p.o. bid + dexamethasone initially 40 mg p.o. d1-4 and d15-18, then 20mg d1 and d15. dexamethasone 1 mg p.o. continuously within the intervals of pulsed dexamethasone therapy"
16249711|NCT01010230|Device|LMHF mechanical stimulation active device|"Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention."
16249712|NCT01010230|Device|LMHF mechanical stimulation placebo device|"Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention."
16249713|NCT01010217|Drug|Cyclophosphamide|50 mg/kg/day intravenous (IV) over 3 hours on Days 3 and 4.
16249714|NCT01010217|Drug|Fludarabine|40 mg/m^2 IV over 1 hour on Days -6, -5, -4, and -3.
16249715|NCT01010217|Drug|Melphalan|140 mg/m^2 IV (or 100 mg/m^2 with reduced intensity Regimen 2) over 30 minutes on Day -8.
16249716|NCT01010217|Drug|Mesna|10 mg/kg IV every 4 hours for a total of 10 doses starting just prior to first dose of Cyclophosphamide on Days 3 and 4.
16249717|NCT01010217|Drug|Rituximab|CD20+ lymphoid malignancies: 375 mg/m2 on Day -13 followed by 1000 mg/m2 on Day -6, +1, and +8.
16249718|NCT01010217|Procedure|Stem Cell Transplantation|Infusion of donor's stem cells by vein on Day 0, may last anywhere from 15 minutes to several hours.
16249719|NCT01010217|Drug|Thiotepa|5 mg/kg Regimen 1 (or 5 mg/kg with reduced intensity Regimen 2) IV over 4 hours on Day -7.
16249720|NCT01010217|Drug|Tacrolimus|0.015 mg/kg by vein or orally daily starting on Day +5 for 3 months
16249721|NCT01010217|Drug|Mycofenolate mofetil|15 mg/kg/dose orally three times a day starting on Day +5 to Day +100 or otherwise indicated
16249722|NCT01010217|Drug|G-CSF|5 mcg/kg/day subcutaneously starting Day 7 once a day daily until neutrophil recovery > 1000/mcl.
16249723|NCT01010204|Drug|Varenicline|Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
16249724|NCT01010204|Drug|Placebo|Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
16249725|NCT01010191|Other|Sugar pill|
16249726|NCT01010178|Drug|Macrolid, Theophylline, Inhaler Corticosteroids|we have no permission to include them in detail because of privacy policy of mentioned journal for publication
16249727|NCT01010152|Drug|Codeine Sulfate|30 mg Tablet
16249728|NCT01010139|Drug|Codeine Sulfate|15 mg, 30 mg and 60 mg Tablet
16249729|NCT01010126|Biological|Bevacizumab|Given IV
16249730|NCT01010126|Drug|Temsirolimus|Given IV
16249731|NCT01010113|Other|Standard infant formula with prebiotics|From 0-6 months of age. As per standard requirement
16249732|NCT01010113|Other|Infant formula with synbiotics|From 0-6 months of age as per standard requirement
16249733|NCT01010100|Drug|Acarbose (Glucobay, BAYG5421)|50 mg TID
16249734|NCT01010100|Drug|Placebo|50 mg TID
16249735|NCT01010087|Drug|Oseltamivir|standard (75 mg bid) or high-dose (225 mg bid) oseltamivir
16249736|NCT01010061|Drug|obinutuzumab|1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
16249737|NCT01010061|Drug|rituximab|375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6.
16249742|NCT01010022|Drug|6% hydroxyethyl starch 70/0.5 (Salinhes®)|Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
16249743|NCT01010009|Dietary Supplement|Trans- resveratrol|All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.
16249744|NCT01010009|Other|Placebo (silica)|All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.
16249745|NCT01009996|Procedure|Kissing DEB|Provisional bare metal stenting followed by kissing drug-eluting balloons
16249746|NCT01009983|Biological|panitumumab|Given IV
16249747|NCT01009983|Drug|paclitaxel|Given IV
16249748|NCT01009983|Drug|carboplatin|Given IV
16249749|NCT01009983|Procedure|laboratory biomarker analysis|Correlative study
16249750|NCT01009983|Procedure|immunohistochemistry staining method|Correlative study
16249751|NCT01009970|Drug|Rituximab|375 mg/m2 day 1
16249752|NCT01009970|Drug|Cyclophosphamide|750 mg/m2 day 2
16249753|NCT01009970|Drug|Vincristine|1,4 mg/m2 (max 2 mg) day 2
16249754|NCT01009970|Drug|Prednisone|40 mg/m2 day 2-6
16249755|NCT01009970|Drug|Doxorubicin|50 mg/m2 day 2
16249756|NCT01009957|Drug|Everolimus|0.75 mg x 2 / day
16249757|NCT01009944|Drug|Lisinopril, Atenolol|once a day for 14 weeks
16249758|NCT01009931|Drug|12-O-tetradecanoylphorbol-13-acetate|The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.
16249759|NCT01009931|Drug|Dexamethasone|Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.
16249760|NCT01009931|Drug|Choline magnesium trisalicylate|"Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.
~Up to 6 cycles."
16249761|NCT01009918|Drug|Coreg CR®|Given orally
16249762|NCT01009918|Drug|lisinopril|Given orally
16249763|NCT01009918|Other|placebo|Given orally
16249764|NCT01009905|Drug|somatropin|Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice
16249765|NCT01009892|Drug|Codeine Sulfate|Tablet
16249766|NCT01009879|Drug|Etanercept|Etanercept 50 mg SQ qweek
16249767|NCT01009866|Biological|MR1-1|Based on preclinical toxicity studies, the starting total drug dose will be 0.5μg (500ng) which represents 1/20th of the MTD in rats. The infusion flow rate will be fixed at 0.5 mL/h from each of two catheters. A total of 96 mLs of drug solution will be delivered over 96 hours. MR1-1KDEL dose escalation will be accomplished by increasing drug concentration allowing flow rate and infusion volume to remain unchanged. Drug dose will be doubled in successive cohorts so long as DLTs are not observed as follows: 25 ng/mL (2.4 μg)(starting dose); 50ng/mL (4.8μg); 100 ng/mL (9.6μg); 200ng/mL (19.2μg); 400 ng/mL (38.4μg); 800 ng/mL (76.8μg); and 1600 ng/mL (153.6μg).
16249768|NCT01009853|Drug|Codeine Sulfate|15 mg tablet
16249769|NCT01009840|Drug|IV busulfan|PK-directed dosing of IV busulfan for 4 days
16249770|NCT01009840|Drug|bortezomib|Single IV bortezomib at a dose of 1.3 mg/m^2.
16249771|NCT01009840|Procedure|Autologous Hematopoietic Stem Cell Transplant (HSCT)|
16249772|NCT01009827|Other|Observation|Participants will have biomedical information extracted from their medical chart, will complete the ACASI questionnaire and have a face-to-face post-ACASI debriefing interview administered. Participants who do not have a documented HIV-1 viral load and/or CD4+ T-cells count from within the previous six months will also have venipuncture performed to obtain a blood sample for these tests to be performed.
16249773|NCT01009814|Drug|BMS-663068|BMS-663068 will be administered as a tablet formulation
16249774|NCT01009814|Drug|Ritonavir|Ritonavir will be administered as a capsule.
16249775|NCT01009801|Drug|doxorubicin-eluting beads|Patients receive oral placebo or everolimus once daily for up to 12 months and undergo TACE comprising doxorubicin-eluting beads as in phase I at the MTD.
16249776|NCT01009801|Drug|everolimus|Patients receive oral everolimus once daily for up to 12 months and undergo TACE comprising doxorubicin-eluting beads as in phase I at the MTD.
16249777|NCT01009801|Other|placebo|Patients receive oral placebo once daily for up to 12 months and undergo TACE comprising doxorubicin-eluting beads as in phase I at the MTD.
16249778|NCT01009788|Drug|ABT-888|Capsules taken orally twice a day on days 1-7 of each 28 day cycle
16249779|NCT01009788|Drug|temozolomide|capsules taken orally once a day on days 1 through 5 of a 28 day cycle
16249780|NCT01009775|Drug|YM155|intravenous infusion
16249781|NCT01009775|Drug|Docetaxel|intravenous infusion
16249782|NCT01009762|Biological|peptide vaccine (AFO-18)|18 Peptides (250 ug of each peptide) in Adjuvant CAF01 (= 625/125 ug DDA/TDB), i.m. injection week 0, 2, 4, 8.
16249783|NCT01009749|Behavioral|Motivational Enhancement System for Adherence (MESA)|MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications.
16249784|NCT01009749|Behavioral|Motivational Enhancement System for Health (MESH)|Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
16249785|NCT01009736|Dietary Supplement|tomato-soy juice|
16249786|NCT01009736|Other|laboratory biomarker analysis|
16249787|NCT01009736|Other|pharmacological study|
16249788|NCT01009736|Procedure|therapeutic conventional surgery|
16249789|NCT01009697|Drug|Codeine Sulfate|15 mg, 30 mg, and 60 mg tablets
16249790|NCT01009671|Drug|ART 44|
16249791|NCT01009671|Drug|ART 50|
16249792|NCT01009658|Dietary Supplement|Monosodium glutamate|Oral intake of 2.0 g of monosodium glutamate on the examination day and 0.6 g of sodium chloride on the other examination day.
16249793|NCT01009658|Dietary Supplement|Sodium chloride|Oral intake of 0.6 g of sodium chloride on the examination day and 2.0 g of monosodium glutamate on the other examination day.
16250167|NCT01007110|Dietary Supplement|DHA|Docosahexaenoic Acid (DHA) from algal oil
16249794|NCT01009645|Behavioral|Fact Only Education Message|Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.
16249795|NCT01009645|Behavioral|Fact and Myth Educational Message|Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.
16249796|NCT01009645|Behavioral|Fact, Myth, Why Educational Message|Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.
16249797|NCT01009645|Behavioral|Control Educational Message|Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.
16249798|NCT01009632|Behavioral|Resonant voice|4-hr of resonant voice exercise
16249799|NCT01009632|Behavioral|Voice rest|4-hr of complete refrain from any voice use
16249800|NCT01009632|Behavioral|Spontaneous speech|
16249801|NCT01009619|Drug|Azithromycin|Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.
16249802|NCT01009619|Drug|Placebo|Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.
16249803|NCT01009606|Other|Usual strategy|Usual strategy
16249804|NCT01009606|Other|Modified strategy|Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation
16249805|NCT01009593|Drug|ABT-869|Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
16249806|NCT01009593|Drug|Sorafenib|Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
16249807|NCT01009580|Drug|insulin degludec/insulin aspart|Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
16249808|NCT01009580|Drug|biphasic insulin aspart 30|Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
16249809|NCT01009567|Drug|Cabergoline|Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
16249810|NCT01009567|Drug|Control|Receive human albumin 20% infusion
16249811|NCT01009554|Device|Potassium Oxylate Mouthwash|Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice
16249812|NCT01009554|Drug|Sodium Fluoride Dentifrice|Brush in usual manner, twice daily, with a sodium fluoride dentifrice
16249813|NCT01009541|Drug|Pregabalin controlled release, 82.5 mg|82.5 mg controlled release tablet administered once daily for three days.
16249814|NCT01009541|Drug|Pregabalin controlled release, 165 mg|165 mg controlled release tablet administered once daily for three days.
16249815|NCT01009541|Drug|Pregabalin controlled release, 330 mg|330 mg controlled release tablet administered once daily for three days.
16249816|NCT01009541|Drug|Pregabalin immediate release, 150 mg|150 mg immediate release capsules administered every 12 hours for three days
16249817|NCT01009528|Device|Electronic feedback system on diabetes care|An electronic feedback system was introduced in randomized primary care clinics providing an overview of quality of care. The intervention ran for 15 months.
16249818|NCT01009515|Drug|Paclitaxel, carboplatin, temozolomide|Combination chemotherapy was administered for up to 6 cycles
16249819|NCT01009502|Drug|sodium stibogluconate|Sodium stibogluconate 900 mg/m2/day will be given on Monday through Friday every other week for the first 16 weeks of the study (on the 1st, 3rd, 5th, 7th, 9th, 11th, 13th and 15th weeks). On the alternate weeks patients will not receive any study treatment.
16249820|NCT01009476|Drug|Galantamine|Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of galantamine (8 mg,16 mg, 24 mg retard capsule) was to be in accordance with the recommendations given in the summary of product characteristics.
16249821|NCT01009476|Drug|Nootropics (ginkgo biloba, nicergoline, piracetam, or others)|Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of nootropics was to be in accordance with the recommendations given in the relevant summary of product characteristics.
16249822|NCT01009463|Drug|FF/GW642444 Inhalation Powder|Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD
16249823|NCT01009463|Drug|GW642444 Inhalation Powder|Long Acting Beta Agonist(LABA) Inhalation Powder via DPI
16249824|NCT01009450|Procedure|LC was done using traditional method|LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch.
16249825|NCT01009450|Procedure|LC was done using harmonic ACE|LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch.
16249826|NCT01009437|Drug|ritonavir|"Phase I: Dose escalation will be used with 3 levels of ritonavir given - 200 mg twice a day (bid), 400 mg bid, and 600 mg bid.
~Phase II: Dose will be maximum tolerated dose from Phase I."
16249827|NCT01009437|Procedure|therapeutic conventional surgery|Tissue collection is from all patients, including the control, phase I and phase II patients.
16249828|NCT01009424|Drug|R7103|escalating inhaled dose
16249829|NCT01009398|Other|Fluoroscopic examination|Localisation of the paravertebral catheter tip and documentation of the spread of contrast dye injected through the catheters by fluoroscopic examination
16249871|NCT01009138|Behavioral|Diabetes-Specific CBT (DS-CBT)|"5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
~Problem Analysis and Definition
~Problem Solving Intervention
~Cognitive Restructuring
~Activation of personal and social Resources
~Goal Definition and Agreement"
16249830|NCT01009385|Procedure|cervical epidural steroid injection|"After aseptic preparation and skin infiltration with 1% lidocaine
~20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level
~identification of the epidural space confirmed by injection of contrast medium under fluoroscope
~injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl).
~Post-procedure, patients were observed for any adverse effects and followed with a neurological examination"
16249831|NCT01009385|Procedure|epidural pressure measurement|"The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view.
~Identification of the epidural space and measurement of EP was performed with a closed measurement system."
16249832|NCT01009372|Behavioral|IPP|Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient
16249833|NCT01009359|Drug|F-18 DPA-714 (BAY85-8102)|Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
16249834|NCT01009359|Drug|F-18 DPA-714 (BAY85-8102)|Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
16249835|NCT01009359|Drug|F-18 DPA-714 (BAY85-8102)|Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood
16249836|NCT01009346|Drug|RAD001|"Dose Level -1 2.5mg/day
~Dose Level 1 5mg/day*
~Dose Level 2 10mg/day
~MTD RAD001"
16249837|NCT01009346|Drug|Cetuximab|250mg/m2/week
16249838|NCT01009346|Drug|Cisplatin|40mg/m2 Day 1, 8 every 28 days
16249839|NCT01009346|Drug|Carboplatin|"Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:
~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
16249840|NCT01009333|Device|InterStim Therapy at rate 5.2 Hz|All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
16249841|NCT01009333|Device|InterStim Therapy at rate 14 Hz|All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
16249842|NCT01009333|Device|InterStim Therapy|All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.
16249843|NCT01009307|Genetic|polymorphism analysis|
16249844|NCT01009307|Other|laboratory biomarker analysis|
16249845|NCT01009307|Other|medical chart review|
16249846|NCT01009294|Drug|Ataluren|Oral powder
16249847|NCT01009294|Drug|Chronic Corticosteroid Therapy|Enrollment was stratified to ensure evaluation of approximately half of the participants were receiving chronic corticosteroid therapy and approximately half of participants were not receiving chronic corticosteroid therapy. Therefore, 3 out of 6 participants were receiving chronic corticosteriod therapy. For the participants receiving chronic corticosteriod therapy, a stable corticosteriod regimen was to be maintained during the study.
16249848|NCT01009281|Drug|AIN457|
16249849|NCT01009268|Procedure|Orthogeriatric intervention|The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.Clinical routines for the orthogeriatric service has been developed during the pilot phase in 2008 and 2009, and are documented in the electronic library of clinical handbooks at Department of Geriatric Medicine.
16249850|NCT01009255|Drug|GSK239512|Histamine H3 Antagonist
16249851|NCT01009255|Drug|Placebo|Placebo to match GSK239512
16249852|NCT01009242|Biological|CDP6038|"Single dose:
~1 mg/kg CDP6038 IV"
16249853|NCT01009242|Biological|CDP6038|"Single dose:
~0.1mg/kg CDP6038 IV"
16249854|NCT01009242|Biological|CDP6038|"Single dose:
~1.0mg/kg CDP6038 SC"
16249855|NCT01009242|Other|Placebo IV|"Single dose:
~Placebo IV"
16249856|NCT01009242|Other|Placebo SC|"Single dose:
~Placebo SC"
16249857|NCT01009242|Drug|CDP 6038 SC|Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo
16249858|NCT01009242|Drug|Methotrexate|Individual stable doses of methotrexate.
16249859|NCT01009229|Dietary Supplement|Low and high salt diets|High salt diet: 150mmol/d Low salt diet: 30mmol/d
16249860|NCT01009216|Drug|ABT-384|Doses will be administered daily for 5 days.
16249861|NCT01009203|Drug|Erlotinib|Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
16249862|NCT01009203|Drug|Temsirolimus|In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of temsirolims to 20 mg intravenously weekly is permitted after the first 28 day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
16249863|NCT01009190|Drug|PF-01367338|Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle
16249864|NCT01009190|Drug|Carboplatin|Standard doses of intravenous Carboplatin administered every 3 weeks
16249865|NCT01009190|Drug|PF-01367338|RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
16249866|NCT01009190|Drug|Carboplatin|Standard doses of intravenous Carboplatin administered every 3 weeks
16249867|NCT01009177|Drug|Bosentan|Bosentan 500 mg bid
16249868|NCT01009177|Drug|Placebo|Placebo
16249869|NCT01009151|Behavioral|Heart Self Care Tracker|Web-based home tele-monitoring system serving congestive heart failure patients at the University of Michigan Health System. The intervention consists of daily reporting via the Internet on parameters specified in clinical protocols, including weight, blood pressure, heart rate and heart failure symptoms. These protocols contain automated trigger mechanisms when certain values are exceeded to alert the provider and the patient for the need to take appropriate remedial action. The system provides links to educational material on heart failure and reminders for self-care measures.
16249870|NCT01009151|Behavioral|Heart Care Self Tracker|Web-based Home Tele-monitoring System
16250069|NCT01007721|Drug|BI 671800 ED 100 mg|4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
16249872|NCT01009138|Behavioral|Standard Diabetes Education|"Standard Diabetes Education Lesson including
~Health Care and specific Topics (e. g. Blood Pressure)
~Social Aspects of Living with Diabetes
~Diabetes Complications
~Sports, Activities and Exercise
~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
16249873|NCT01009125|Other|$2 cash|$2 cash incentive will be included in the mailed survey
16249874|NCT01009125|Other|$5 cash|$5 cash incentive will be included in the mailed survey
16249875|NCT01009112|Behavioral|PTSD + IRT/CBT-I|6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
16249876|NCT01009112|Behavioral|PTSD + Supportive Care Therapy|6 weeks of prolonged exposure + 12 weeks of supportive care therapy
16249877|NCT01009099|Other|breathing retraining|breathing retraining using a metronome
16249878|NCT01009099|Other|exercise training|treadmill exercise training
16249879|NCT01009086|Drug|Placebo|SC injections
16249880|NCT01009086|Drug|Ustekinumab 45 mg|SC injections
16249881|NCT01009086|Drug|Ustekinumab 90 mg|SC injections
16249882|NCT01009073|Drug|ABT-263|"ABT-263 is taken orally.
~Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed."
16249883|NCT01009073|Drug|erlotinib|150 mg of erlotinib is taken orally once daily.
16249884|NCT01009073|Drug|irinotecan (3-week schedule)|"180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle.
~Note - The dose and schedule is subject to change based on the toxicities observed."
16249885|NCT01009073|Drug|irinotecan (weekly schedule)|"75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle.
~Note - The dose and schedule is subject to change based on the toxicities observed."
16249886|NCT01009060|Drug|GSK239512|Histamine H3 Antagonist
16249887|NCT01009060|Drug|Placebo|Placebo to match GSK239512
16249888|NCT01009047|Drug|Paliperidone extended release (ER)|Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
16249889|NCT01009047|Drug|Aripiprazole|Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
16249890|NCT01009034|Other|Measuring semen samples|Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
16249891|NCT01009021|Drug|potassium diclofenac|potassium diclofenac 50 mg, one tablet 45 minutes before laser treatment
16249892|NCT01009008|Device|Patient Activated Controlled Expansion Device|Patient activated controlled expansion for post-mastectomy breast reconstruction
16249893|NCT01008995|Drug|placebo|Subcutaneous injection at Week 0 and 4
16249894|NCT01008995|Drug|ustekinumab|45 mg subcutaneous injection at Week 12 and 16
16249895|NCT01008995|Drug|placebo|Subcutaneous injection at Week 12
16249896|NCT01008995|Drug|ustekinumab|45 mg subcutaneous injection at Week 0, 4 and 16
16249897|NCT01008982|Drug|LimphoStat-B|subjects will receive 10 mg/kg belimumab, in solution for infusion, monthly
16249898|NCT01008969|Other|SPECT-CT imaging|SPECT/CT for 3-dimensional mapping of 99mTc-sulfur nanocolloid in order to identify personalized lymphatic drainage patterns
16249899|NCT01008956|Biological|GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A|Intramuscular injection, one dose
16249900|NCT01008943|Biological|Autologous Muscle Derived Cells|Urethral injection of autologous muscle-derived cells
16249901|NCT01008930|Procedure|HR PEM Scan|PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of body that has, or is suspected to have cancer following routine, standard, positron emission tomography/computed tomography (PET/CT) scan
16249902|NCT01008917|Drug|sorafenib with temsirolimus|Weekly intravenous temsirolimus with daily oral sorafenib
16249903|NCT01008904|Drug|magnesium oxide|Given PO
16249904|NCT01008904|Other|questionnaire administration|Ancillary studies
16249905|NCT01008904|Procedure|quality-of-life assessment|Ancillary studies
16249906|NCT01008878|Behavioral|interdisciplinary intervention|
16249907|NCT01008865|Procedure|Studer Pouch orthotopic urinary diversion|
16249908|NCT01008865|Procedure|T-Pouch orthotopic urinary diversion|
16249909|NCT01008852|Drug|SBI-087|200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
16249910|NCT01008852|Drug|SBI-087|200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
16249911|NCT01008852|Drug|SBI-087|200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
16249912|NCT01008852|Drug|SBI-087|200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
16249913|NCT01008852|Drug|Placebo|Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
16249914|NCT01008826|Dietary Supplement|broccoli sprouts extract|Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice
16249915|NCT01008813|Biological|adjuvanted A(H1N1)v influenza vaccine|Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (3,8 microgram) adjuvanted with AS 03A
16249916|NCT01008813|Biological|non-adjuvanted A(H1N1)v influenza vaccine|Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)
16249917|NCT01008800|Behavioral|Social Communication|The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.
16250168|NCT01007110|Other|Placebo|Placebo capsule
16249918|NCT01008800|Behavioral|Social communication|Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).
16249919|NCT01008787|Behavioral|Training|In-person 8-hour group physical activity training session (either over 1 or 2 days) and receive workbook and pedometer.
16249920|NCT01008787|Behavioral|Questionnaire|Weekly during Weeks 2-7, complete question form given at training course about conversations with study partner, 5 minutes to complete.
16249921|NCT01008787|Behavioral|Interview|Weeks 4 and 8, 30 minute phone interview about mood and physical activity.
16249922|NCT01008787|Behavioral|PA Newsletter|At Weeks 5 and 9, receive a physical activity (PA) newsletter.
16249923|NCT01008774|Device|Paxman Cooling Machine|Scalp cooling procedures
16249924|NCT01008774|Device|Cold Caps|Scalp cooling procedures
16249925|NCT01008761|Drug|Azithromycin|Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)
16249926|NCT01008761|Drug|Suspension Placebo|Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg
16249927|NCT01008748|Drug|Nicotine Replacement Therapy (NRT)|NRT for participants who smoke >10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits.
16249928|NCT01008748|Behavioral|Questionnaire|Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
16249929|NCT01008748|Behavioral|Counseling|Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish.
16249930|NCT01008748|Behavioral|Self-Help Materials|Spanish-language self-help materials currently used by the NCI's Cancer Information Service.
16249931|NCT01008709|Device|Teleflex HemoLock clip|Patients randomized to the Aesculap U-clip device or the HemoLock clip will undergo their respective surgery (robotic prostatectomy and laparoscopic and robotic renal surgery) as per standard protocols. During the surgical procedure, when primary vascular control is warranted the appropriate clip to which the patient has been randomized will be utilized. Immediate assessment of the vascular pedicle will subsequently occur; if hemostasis is not adequate, additional clipping, endomechanical stapling or suture ligation will then be performed as necessary.
16249932|NCT01008709|Device|Aesculap U-clip|Patients randomized to the Aesculap U-clip device or the HemoLock clip will undergo their respective surgery (robotic prostatectomy and laparoscopic and robotic renal surgery) as per standard protocols. During the surgical procedure, when primary vascular control is warranted the appropriate clip to which the patient has been randomized will be utilized. Immediate assessment of the vascular pedicle will subsequently occur; if hemostasis is not adequate, additional clipping, endomechanical stapling or suture ligation will then be performed as necessary.
16249933|NCT01008696|Drug|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.
16249934|NCT01008696|Drug|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.
16249935|NCT01008657|Procedure|Radiofrequency ablation|Percutaneous multipolar radiofrequency ablation.
16249936|NCT01008644|Other|Water|The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
16249937|NCT01008644|Other|Saline 3%|The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min
16249938|NCT01008631|Drug|Sodium thiosulfate|6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
16249939|NCT01008618|Drug|Fentanyl|One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.
16249940|NCT01008618|Drug|Placebo|Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.
16249941|NCT01008605|Other|delivery system|syringe
16249942|NCT01008592|Drug|levocetirizine or placebo|oral administration, single tablet, 5 mg.
16249943|NCT01008566|Biological|Cixutumumab|Given IV
16249944|NCT01008566|Other|Laboratory Biomarker Analysis|Correlative studies
16249945|NCT01008566|Drug|Sorafenib Tosylate|Given orally
16249946|NCT01008553|Drug|Fentanyl|One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.
16249947|NCT01008553|Drug|Placebo|Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.
16249948|NCT01008540|Biological|depistage|Virus isolation from urine, blood, or any suitable sample in case of CMV disease Resistance phenotype to antivirals UL97 and UL54 genes sequencing from blood, urines or any suitable samples for resistance mutations detection and polymorphism study
16249949|NCT01008527|Drug|CP 870,893|Study drug will be administered open-label as an intravenous solution, followed by observation. Study drug will be supplied as a liquid intravenous solution in vials containing 10 mg/mL of CP870,893. CP 870,893 will be administered at a dosage of 0.01, 0.025 or 0.05 mg/kg at 0.24 mg/mL infused via a syringe pump over 15 minutes, or at 0.1 or 0.2 mg/kg/dose as an i.v. infusion in saline at a concentration of 0.24 mg/mL in an IV bag of up to 100 mL over 30 minutes (controlled by a volumetric pump) for not more than 30 minutes, with a 10 cc flush at the end that should be administered at the same rate as the CP 879,893 infusion.
16249950|NCT01008527|Biological|Peptides|NY-ESO-l 157-165 (165V) and gpl002 80-288 (288V) peptides each at a dose of 0.5 mg will be emulsified with Montanide ISA 51 VG and administered to all patients in the study at Weeks 1,3, 5, 7, 9, 11, 17, 21, 25 33, 41, and 53. Peptides will be administered as a total of 6 deep subcutaneous (s.c.) injections into alternating lower extremities one hour after CP 870,893 infusions.
16250070|NCT01007721|Drug|BI 671800 ED placebo|4 capsules of BI 671800 ED placebo (bid in the morning and evening)
16249951|NCT01008527|Biological|Oncovir poly IC:LC|The dosage of poly IC:LC chosen for the current trials has been used safely in over one hundred patients with central nervous system (CNS) malignancies enrolled in nitrates and bone turnover (NABT) trials. The injection of 1000 mcg will be made deeply subcutaneously into the same limb as the peptides/Montanide ISA 51 VG, at least 5 cm. proximal to the peptides vaccination site. Poly IC:LC will be administered to all patients in the study at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25 33, 41, and 53 one hour after CP 870,893 infusion.
16249952|NCT01008514|Procedure|adjuvant therapy|
16249953|NCT01008514|Radiation|accelerated partial breast irradiation|
16249954|NCT01008514|Radiation|intracavitary balloon brachytherapy|
16249955|NCT01008488|Drug|Antibiotic|Antibiotic according to local treatment routine against bowel pathogenesis
16249956|NCT01008475|Drug|EMD 525797 250 mg|EMD 525797 will be administered at a target dose of 250 mg as a 1-hour intravenous infusion for every 2 week until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
16249957|NCT01008475|Drug|EMD 525797 500 mg|"Safety part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
~Randomized part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent."
16249958|NCT01008475|Drug|EMD 525797 750 mg|EMD 525797 will be administered at a target dose of 750 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
16249959|NCT01008475|Drug|EMD 525797 1000 mg|"Safety part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
~Randomized part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent."
16249960|NCT01008475|Drug|Cetuximab|"Safety part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until DLT.
~Randomized part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent."
16249961|NCT01008475|Drug|Irinotecan|"Safety part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
~Randomized part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent."
16249962|NCT01008462|Procedure|Allogeneic Bone Marrow Transplantation|Undergo donor HCT
16249963|NCT01008462|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo donor HCT
16249964|NCT01008462|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC transplant
16249965|NCT01008462|Procedure|Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation|Undergo autologous-donor tandem HCT
16249966|NCT01008462|Drug|Carmustine|Given IV
16249967|NCT01008462|Drug|Cyclophosphamide|Given IV
16249968|NCT01008462|Drug|Cytarabine|Given IV
16249969|NCT01008462|Drug|Etoposide|Given IV
16249970|NCT01008462|Drug|Fludarabine Phosphate|Given IV
16249971|NCT01008462|Other|Laboratory Biomarker Analysis|Correlative study
16249972|NCT01008462|Drug|Melphalan|Given IV
16249973|NCT01008462|Drug|Mycophenolate Mofetil|Given PO
16249974|NCT01008462|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo donor HCT
16249975|NCT01008462|Drug|Tacrolimus|Given IV or PO
16249976|NCT01008462|Radiation|Total-Body Irradiation|Undergo TBI
16249977|NCT01008449|Device|Surgical staples|Surgical staples will be used once for wound closure.
16249978|NCT01008449|Device|Absorbable Surgical Suture|Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.
16249979|NCT01008436|Drug|Omni-stat Celox|Topical administration of 6 gr of Omnistat Celox
16249980|NCT01008436|Drug|Control|Traditional surgical Hemostasis
16249981|NCT01008423|Drug|Budesonide|Budesonide will be administered as per the dose and schedule specified in the respective arm.
16249982|NCT01008423|Drug|Placebo|Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm.
16249983|NCT01008410|Drug|Budesonide|Budesonide will be administered as per the dose and schedule specified in the respective arm.
16249984|NCT01008410|Drug|Placebo|Placebo matching to budesonide will be administered as per the schedule specified in the respective arm.
16249985|NCT01008397|Drug|AHIST NDC#58407-012-01|Oral tablet containing chlorpheniramine tannate 12mg.
16249986|NCT01008384|Dietary Supplement|Vitamin D3|50,000 units taken orally once a week for 8 weeks
16249987|NCT01008345|Drug|ezetimibe|Patients will receive 10 mg/day of ezetimibe for 8 weeks
16249988|NCT01008332|Biological|Toleromune HDM|ToleroMune HDM dose 1x4 administrations 4 weeks apart
16249989|NCT01008332|Biological|Placebo|Placebo comparator, 1x4 administrations 4 weeks apart
16250071|NCT01007721|Drug|BI 671800 ED placebo|4 capsules of BI 671800 ED placebo (bid in the morning and evening)
16250072|NCT01007721|Drug|BI 671800 ED placebo|4 capsules of BI 671800 ED placebo (bid in the morning and evening)
16249990|NCT01008319|Drug|clomiphene citrate|Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.
16249991|NCT01008319|Drug|clomiphene citrate|Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, a blood draw (to test progesterone level) will be done. Increased dose of clomiphene citrate for 5 days starting that day. A repeat transvaginal ultrasound in one week to determine if there is a dominant follicle. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.
16249992|NCT01008293|Drug|VSL#3|VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)
16249993|NCT01008293|Drug|Lactulose|30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.
16249994|NCT01008280|Drug|baclofen|baclofen 10 mg tid
16249995|NCT01008280|Drug|placebo|placebo pill tid
16249996|NCT01008254|Behavioral|Musical prompt|Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 12 months.
16249997|NCT01008254|Behavioral|Delayed musical prompt|Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 6 months.
16249998|NCT01008254|Other|No musical prompt|No intervention.
16249999|NCT01008228|Procedure|exsufflation|exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
16250000|NCT01008228|Procedure|thoracic tube drainage|thoracic tube drainage will be performed with a tube Ch 16 or ch 20
16250001|NCT01008215|Other|Algorithm|Warfarin Dosing algorithm (paper and electronic version)
16250002|NCT01008176|Behavioral|Sleep extension|Habitual sleep duration is extended by 60min/night over a 6-week time period.
16250008|NCT01008137|Biological|H1N1 influenza A Vaccine (PANFLU.1)|H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)
16250009|NCT01008137|Biological|Trivalent Inactivated Influenza Vaccine (ANFLU)|Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)
16250010|NCT01008124|Other|Liberatory Maneuver|3 cycles of the liberatory maneuver initial session.
16250011|NCT01008124|Other|Placebo maneuver|3 cycles placebo maneuver initial session.
16250012|NCT01008111|Drug|Dermabond|On Day 0 patients will undergo bilateral inguinal surgery. One side will be dressed using a standard surgical dressing, while the other will use a combination hydrogen peroxide/baking soda gel placed over the wound and covered with a sealing dressing. The study team will determine which side gets assigned standard surgical dressing by the flip of a coin.
16250013|NCT01008111|Drug|Hydrogen Peroxide Oxygen producing gel|On Day 0 patients will undergo bilateral inguinal surgery. One side will be dressed using a standard surgical dressing, while the other will use a combination hydrogen peroxide/baking soda gel placed over the wound and covered with a sealing dressing. The study team will determine which side gets assigned standard surgical dressing by the flip of a coin.
16250014|NCT01008098|Drug|escitalopram (lexapro)|0 - 4 week: 10 mg escitalopram a day 5 - 8 week: 20 mg escitalopram a day
16250015|NCT01008085|Device|Stentys coronary stent|Self-expanding Nitinol stent
16250016|NCT01008085|Device|Balloon-expandable stent|VISION/Driver
16250017|NCT01008059|Drug|Alfentanil|No drug treatment before alfentanil
16250018|NCT01008046|Drug|combined N-acetyl cysteine -CC|N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles
16250019|NCT01008046|Drug|combined metformin-CC|Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles
16250020|NCT01008033|Drug|IDP-108|Topical application once a day for 48 weeks
16250021|NCT01008033|Drug|Vehicle|Topical application once a day for 48 weeks
16250022|NCT01008020|Dietary Supplement|tea catechin extracts|Tea catechin extracts 540 mg/day, are consumed for 5 months.
16250023|NCT01008007|Dietary Supplement|Viusid|One Viusid bag (4 grams, orally administered) every 8 hours, for 6 days in combination with the conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.
16250024|NCT01008007|Drug|Conventional treatment|Conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.
16250073|NCT01007721|Drug|BI 671800 ED 100 mg|2 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
16250074|NCT01007721|Drug|671800 ED placebo|2 capsules of BI 671800 ED placebo (bid in the morning and evening)
16250025|NCT01007994|Drug|New Medication: Enalapril, Isradipine, Propranolol|"Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added.
~Dosing will be as follows:
~ACEI: Enalapril < 40 kg starting dose 2.5 mg titrate to 5 mg > 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine < 40 kg 2.5 mg > 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol <40 kg starting dose 10 mg titrate to 20 mg >40 kg starting dose 20 mg titrate to 40 mg"
16250026|NCT01007968|Drug|LBH589|
16250027|NCT01007929|Drug|14C-AZD1236|Oral solution 1mg/mL
16250028|NCT01007916|Device|Lotrafilcon B contact lens|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
16250029|NCT01007916|Device|Habitual contact lens|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
16250030|NCT01007903|Behavioral|Tai Chi exercise|12-week tai chi exercise class
16250031|NCT01007890|Other|ChemoFX Assay|Test of an algorithm to predict pathologic response in patients treated with neoadjuvant chemotherapy for breast cancer.
16250032|NCT01008358|Biological|CP 675,206|
16250033|NCT01008189|Behavioral|Self- study comparison group|Caregivers, children and adolescents each received three books about coping with grief following the death of a loved one plus a syllabus to guide reading
16250034|NCT01008189|Behavioral|Family Bereavement Program|12 session groups for caregivers and bereaved children and adolescents plus two individual sessions
16250035|NCT01008163|Drug|YY-351/Placebo|comparison of different dosages of drug
16250036|NCT01008163|Drug|YY-351/Placebo|comparison of different dosages of drug
16250037|NCT01008163|Drug|YY-351|comparison of different dosages of drug
16250038|NCT01008163|Drug|Placebo|comparison of different dosages of drug
16250039|NCT01007942|Drug|everolimus|Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
16250040|NCT01007942|Drug|Placebo|Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
16250041|NCT01007942|Drug|vinorelbine|intravenous vinorelbine (25 mg/m2 weekly)
16250042|NCT01007942|Drug|trastuzumab|intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
16250043|NCT01007877|Other|Red Bull Energy drink|During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.
16250044|NCT01007864|Drug|piribedil|Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.
16250045|NCT01007864|Drug|pramipexole or ropinirole|continuation of pre-study treatment regimen
16250046|NCT01007851|Drug|triptorelin acetate|single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
16250047|NCT01007851|Drug|NaCl %0.9|0.1 ml sterile saline sc injection 3 days after embryo transfer
16250048|NCT01007838|Other|Progressive resistance training programme|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
16250049|NCT01007838|Other|Sham exercise|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
16250050|NCT01007838|Other|Progressive resistance training|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
16250051|NCT01007838|Other|Sham exercise|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
16250052|NCT01007812|Device|Lotrafilcon B contact lens|Silicone hydrogel, toric, soft contact lens
16250053|NCT01007812|Device|Comfilcon A contact lens|Silicone hydrogel, toric, soft contact lens
16250054|NCT01007799|Dietary Supplement|vitamin D placebo|12 weeks of placebo
16250055|NCT01007799|Dietary Supplement|Vitamin D|12 weeks supplementation based on serum vitamin D levels
16250056|NCT01007773|Drug|Precedex|Once this patient is deemed stable on the propofol infusion, the patient will be started on a dexmedetomidine infusion at 0.4 mcg/kg/hr. The dexmedetomidine infusion will be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -1 (maximum rate of 1.5 mcg/kg/hr). In the meantime, once sustained ICP control has been achieved, the initial sedative agent (usually propofol) will be weaned. Dexmedetomidine will be infused for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued. When the patient is ready to come off sedation, the dexmedetomidine will be weaned by 50% every hour over a 4-hour period to off.
16250057|NCT01007773|Drug|Propofol|Propofol will be initiated at 25 mcg/kg/min and titrated to achieve an ICP < 20 mm Hg (up to a maximum of 75 mcg/kg/min). Propofol will be continued for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued.
16250058|NCT01007773|Drug|Fentanyl|Fentanyl will be initiated and titrated to achieve adequate pain control.
16250059|NCT01007773|Drug|Propofol|Propofol will be titrated to an ICP < 20 mm Hg until achievement of sustained ICP control.
16250060|NCT01007760|Other|Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke|acute one time exposure
16250061|NCT01007747|Other|Geranium oil|Daily topical application over neuropathic pain
16250062|NCT01007721|Drug|BI 67100 ED 25 mg|2 capsules of BI 671800 ED 25 mg
16250063|NCT01007721|Drug|BI 671800 ED placebo|2 capsules of BI 671800 ED placebo (bid in the morning and evening)
16250064|NCT01007721|Drug|montelukast placebo tablet|1 over-encapsulated montelukast placebo tablet (qd in the morning)
16250065|NCT01007721|Drug|montelukast placebo tablet|1 over-encapsulated montelukast placebo tablet (qd in the morning)
16250066|NCT01007721|Drug|fluticasone propionate placebo nasal spray|fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
16250067|NCT01007721|Drug|fluticasone propionate placebo nasal spray|fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
16250068|NCT01007721|Drug|fluticasone propionate placebo nasal spray|fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
16251888|NCT00994500|Drug|bortezomib|Given IV
16250078|NCT01007721|Drug|montelukast 10 mg tablet|1 over-encapsulated montelukast 10 mg tablet (qd in the morning)
16250079|NCT01007721|Drug|fluticasone propionate placebo nasal spray|fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
16250080|NCT01007721|Drug|fluticasone propionate nasal spray placebo|fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
16250081|NCT01007721|Drug|Fluticasonepropionate nasal spray 200 mcg|Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)
16250082|NCT01007708|Drug|IDP-108|Topical application once a day for 48 weeks
16250083|NCT01007708|Drug|Vehicle|Topical application once a day for 48 weeks
16250084|NCT01007695|Drug|Valproic Acid|Valproic Acid is FDA approved and indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
16250085|NCT01007682|Other|Show distressing movie and tell half of the two study groups to suppress memories of the movie|A distressing movie is presented to two groups (one group with high and one group with low working memory capacity). For each of the two groups, half of the participants are instructed to suppress thoughts of the movies after viewing it, while the remaining participants are instructed to allow the occurrence of memories of the movie.
16250086|NCT01007669|Behavioral|Physical activity and Health check|Strength training, aerobic capacity training.
16250087|NCT01007669|Behavioral|Health check only|Health check
16250088|NCT01007656|Dietary Supplement|GD Antrodia camphorata|Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days
16250089|NCT01007643|Other|Wii Fit (TM) Interactive Video Game|Use of interactive video game exercise program on a daily basis focusing on quadriceps and hamstring flexibility along with VMO strengthening.
16250090|NCT01007643|Other|Traditional Home Exercise Program|Completion of daily home exercise program for quadriceps and hamstring flexibility and VMO strengthening.
16250091|NCT01007630|Drug|Rasagiline|0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
16250092|NCT01007630|Drug|Placebo|0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
16250093|NCT01007617|Device|LLLT :low level laser therapy|"The patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d.
~Main evaluation criteria: mucositis maximal intensity (WHO scale).
~Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition."
16250094|NCT01007604|Device|Peristaltic pulse PCD|Daily use for two hours
16250095|NCT01007604|Other|Exercise and lifestyle counseling|Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
16250096|NCT01007591|Drug|LEO 80190|Applied once daily
16250097|NCT01007591|Drug|Hydrocortisone|Applied once daily
16250098|NCT01007578|Device|Paclitaxel-coated balloon catheter angioplasty|Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries
16250099|NCT01007565|Procedure|periarticular anesthetics injection|Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure . For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve. A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve.
16250100|NCT01007552|Drug|Gemcitabine, Capecitabine and Bevacizumab|Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days.
16250101|NCT01007539|Dietary Supplement|CDP-choline|The subjects will be given 1g citicoline twice daily for a total of 8 weeks.
16250102|NCT01007539|Dietary Supplement|Placebo (fructose)|The Subjects will be given 2 tablets of placebo twice daily for 8 weeks. They will be taking the same quantity as the CDP-choline group.
16250103|NCT01007526|Other|CCRT followed by VIDL chemotherapy|CCRT followed by VIDL chemotherapy concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation
16250104|NCT01007513|Procedure|Transvaginal ultrasound|A transvaginal ultrasound with an endocavitary probe will be done as required by the medical condition of the patient. The cervical and supracervical factors will be noted.
16250105|NCT01007513|Procedure|Vaginal secretion sampling|Vaginal secretion swab will be collected each time patient will have a transvaginal ultrasound. The sample will be centrifuged, frozen and store to be analysed at the end of the study with multiplex antibody arrays.
16250106|NCT01007500|Drug|Dexamethasone|Experimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.
16250107|NCT01007500|Drug|Ondansetron|Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.
16250108|NCT01007474|Device|Implantable Cardioverter-Defibrillator (ICD)|Medtronic market-released implantable cardioverter-defibrillator
16250109|NCT01007474|Device|Implantable Pacemaker Generator (IPG)|Medtronic market-released implantable pacemaker generator
16250110|NCT01007474|Device|Implantable Loop Recorder (ILR)|Medtronic market-released implantable loop recorder
16250111|NCT01007474|Device|Cardiac Resynchronization Therapy-Defibrillator (CRT-D)|Medtronic market-released cardiac resynchronization therapy defibrillator
16250112|NCT01007474|Device|Implantable devices working as neurostimulators, stents, spinal/bone devices or other applications|Medtronic market-released implantable devices used as neurostimulators, stents, spinal/bone devices or for other applications
16250113|NCT01007461|Drug|Sodium Sulfide (Na2S) for Injection|IK-1001 is Na2S administered as an isotonic solution for intravenous (IV) injection or continuous infusion. IK-1001 will be administered as a 3-hour continuous IV infusion started > 5 minutes but < 20 minutes (approximately) prior to coronary artery reperfusion.
16250114|NCT01007461|Drug|Placebo|0.9% Sodium Chloride (NaCl) will be administered in the same manner as the experimental drug.
16250115|NCT01007448|Drug|Bexarotene|Soft gelatin capsules to be taken orally with at least 6 ounces of water or other fluid either with or immediately following the evening meal (a moderate or full meal) or a nutritionally defined liquid food.
16250116|NCT01007435|Drug|Tocilizumab|Tocilizumab was supplied in vials.
16250117|NCT01007435|Drug|Placebo to tocilizumab|Placebo to tocilizumab was supplied in vials.
16250118|NCT01007435|Drug|Methotrexate|Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.
16250119|NCT01007435|Drug|Placebo to methotrexate|Patients received placebo to methotrexate orally once a week.
16250120|NCT01007422|Behavioral|telephone-based intervention|
16250121|NCT01007422|Other|communication intervention|
16250122|NCT01007422|Other|intervention by caregiver|
16250123|NCT01007422|Other|medical chart review|
16250124|NCT01007422|Other|survey administration|
16250125|NCT01007422|Procedure|end-of-life treatment/management|
16250126|NCT01007422|Procedure|pain therapy|
16250127|NCT01007422|Procedure|psychosocial assessment and care|
16250128|NCT01007409|Drug|Fimasartan|Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast
16250129|NCT01007409|Drug|Fimasartan|Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast
16250130|NCT01007396|Other|1-step tuberculin skin test (TST) and blood sampling|In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.
16250131|NCT01007383|Drug|LEO 27847|First in man
16250132|NCT01007370|Procedure|Tracheal intubation|Tracheal intubation through a supraglottic airway device(LMA-Fastrach).
16250133|NCT01007370|Procedure|Tracheal intubation|Tracheal intubation through a supraglottic airway device(I-gel).
16250134|NCT01007357|Device|Body MR imaging|Body MR imaging will be performed to optimize sequences
16250135|NCT01007344|Dietary Supplement|flaxseed|1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
16250136|NCT01007344|Dietary Supplement|whole wheat flour|1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
16250137|NCT01007331|Behavioral|Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07|10^10 colony forming units pr day of probiotics
16250138|NCT01007318|Procedure|Single port laparoscopic appendectomy|Single port through the transumbilical 2-cm incision
16250139|NCT01007318|Procedure|3 port laparoscopic appendectomy|3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
16250140|NCT01007305|Procedure|Bilateral salpingo-oophorectomy|Removal of both ovaries and fallopian tubes at the time of hysterectomy
16250141|NCT01007305|Procedure|Ovarian conservation|Both ovaries and fallopian tubes not removed at the time of hysterectomy
16250142|NCT01007292|Drug|YM155|intravenous infusion
16250143|NCT01007292|Biological|Rituximab|intravenous infusion
16250144|NCT01007279|Drug|ROSUVASTATIN|40 mg before procedure
16250145|NCT01007266|Behavioral|Assignment of a Lay Patient Partner|
16250146|NCT01007253|Drug|PL nasal spray|2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week
16250147|NCT01007253|Drug|fluticasone furoate (FF)|2 puffs of FF nasal spray in each nostril once a day for 1 week
16250148|NCT01007253|Drug|PL eye drops|1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week
16250149|NCT01007253|Drug|olopatadine (OLO)|1 drop of OLO eye drops in each eye once a day for 1 week
16250150|NCT01007240|Device|polyethylenimine (PEI) nanoparticles.|
16250151|NCT01007227|Other|Lifestyle instruction|Instruction dietetic and exercise therapy
16250152|NCT01007214|Procedure|Prostatectomy|Elective prostatectomy
16250153|NCT01007201|Biological|Influenza A (H1N1) 2009 monovalent vaccine, inactivated|
16250154|NCT01007188|Other|1.5PD almonds|average American diet plus 1.5 oz per day almonds
16250155|NCT01007188|Other|3.0PD almonds|average American diet plus 3.0 oz per day almonds
16250156|NCT01007188|Other|Base (without almonds)|average American diet without almonds
16250157|NCT01007175|Biological|ATN-103 10 mg q4wks|ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
16250158|NCT01007175|Biological|ATN-103 30 mg q4wks|ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.3 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
16250159|NCT01007175|Biological|ATN-103 80 mg q4wks|ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections.
16250160|NCT01007175|Biological|ATN-103 10 mg q8wks|ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
16250161|NCT01007175|Biological|ATN-103 80 mg q8wks|ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections.
16250162|NCT01007149|Drug|omalizumab|Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
16250163|NCT01007149|Drug|Placebo|Placebo was supplied in vials with solution for subcutaneous injection.
16250164|NCT01007136|Device|tDCS|1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
16250165|NCT01007136|Device|Sham tDCS|Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
16250166|NCT01007123|Drug|A3309|A3309 in three different dosage levels or placebo once daily for the duration of the study
16250169|NCT01007097|Drug|TAK-875|TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
16250170|NCT01007097|Drug|TAK-875|TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
16250171|NCT01007097|Drug|TAK-875|TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
16250172|NCT01007097|Drug|TAK-875|TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
16250173|NCT01007097|Drug|TAK-875|TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
16250174|NCT01007097|Drug|Glimepiride|TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.
16250175|NCT01007097|Drug|Placebo|TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
16250176|NCT01007084|Drug|Propranolol|40 mg
16250177|NCT01007084|Drug|Propranolol ER|120 mg twice per day
16250178|NCT01007084|Drug|Sugar pills|sugar pill
16250179|NCT01007071|Drug|Human Growth Hormone (1-134)|Subjects randomized to human growth hormone (1-134) for 16 weeks. In this arm, growth hormone is dosed sc on a daily basis and increased over first 6 weeks (Men: start at 0.2 mg sc/d, increase to 0.6 mg sc/d after 4 weeks. Women, postmenopausal: start at 0.3 mg sc/d, increase to 0.9 mg sc/d after 4 weeks. Women premenopausal or on estrogen: start at 0.6 mg sc/d, increase to 1.3 mg sc/d after 4 weeks.) Dose adjustments based on serum IGF-1 levels at 6 and 12 weeks, with final IGF-1 measurement for efficacy performed at 16 weeks, with goal in range of -0.5 SD to +2SD. An elevated serum IGF-1 value will result in a 20% dose reduction in GH in an active and random placebo patient. Similarly, a low serum IGF-1 will result in a 20% dose increase in an active and random placebo subject.
16250180|NCT01007071|Drug|Placebo|Subjects randomized to placebo
16250181|NCT01007032|Biological|Cixutumumab|Cixutumumab intravenously
16250182|NCT01007019|Drug|YH4808 30mg|YH4808 30mg (single dose)
16250183|NCT01007019|Drug|YH4808 50mg|YH4808 50mg (single dose)
16250184|NCT01007019|Drug|YH4808 100mg|YH4808 100mg (single dose)
16250185|NCT01007019|Drug|YH4808 200mg|YH4808 200mg (single dose)
16250186|NCT01007019|Drug|YH4808|YH4808 400mg (single dose)
16250187|NCT01007019|Drug|YH4808 100mg (repeat dose)|YH4808 100mg (repeat dose)
16250188|NCT01007019|Drug|YH4808 200mg (repeat dose)|YH4808 200mg (repeat dose)
16250189|NCT01007019|Drug|YH4808 600mg|YH4808 600mg
16250190|NCT01007019|Drug|YH4808 800mg (single dose)|YH4808 800mg (single dose)
16250191|NCT01007019|Drug|YH4808 400 mg (repeat doses)|YH4808 400 mg (repeat doses)
16250192|NCT01007019|Drug|Placebo|10 volunteers will be administered matched placebo.
16250193|NCT01007019|Drug|Esomeprazole 40mg|24 volunteers will be administered Esomeprazole 40mg
16250194|NCT01007006|Device|TMRDU|The TMRDU will assist study subjects with taking their medications as prescribed by notifying them when the next dose is due and tracking whether and when it was taken.
16250195|NCT01006993|Device|NeuroFlo catheter|NeuroFlo™ catheter 45 minute treatment
16250196|NCT01006980|Drug|Vemurafenib|960 mg (as 240 mg tables) orally twice daily
16250197|NCT01006980|Drug|Dacarbazine|1000 mg/m2 intravenously every 3 weeks
16250198|NCT01006967|Device|ActiveStep Treadmill|The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
16250199|NCT01006967|Other|Physical Therapy|Standard program of physical therapy for gait and balance
16250200|NCT01006954|Drug|Microdose GnRh|Microflare protocol in poor responders for IVF/ICSI
16250201|NCT01006954|Drug|Flare up|Flare up protocol in poor responders for IVF/ICSI
16250202|NCT01006941|Biological|Trichuris suis ova|2500 ova per dose, orally, every second week, during 12 weeks
16250203|NCT01006928|Other|Questionaire|Questionaire to mothers
16250204|NCT01006915|Procedure|Surgery|Surgical decompression of the common peroneal, tibial, and deep peroneal nerves
16250205|NCT01006889|Drug|Exenatide|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
16250206|NCT01006876|Drug|Coumadin|Continuous oral Coumadin therapy through the catheter ablation procedure
16250207|NCT01006876|Drug|Coumadin|Patients discontinue Coumadin 3-4 days prior to ablation and replace it with heparin until the end of the procedure and bridge low molecular weight heparin (LMWH) with Coumadin 48-72 hours after ablation.
16250208|NCT01006876|Drug|Coumadin|Oral tablets, daily dose, till the therapeutic INR of 2-3 is achieved
16250209|NCT01006863|Drug|Ephedrine|Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing either saline 0.9% solution [group 1 (n=30)], ephedrine 0.7 mg/mL [group 2 (n=30)], ephedrine 1 mg/mL [group 3 (n=30)] or ephedrine 1.5 mg/mL [group 4 (n=30)]or phenylephrine 15 mcg/mL [group 5 (n=30)]. All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo and the ephedrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.
16250210|NCT01006863|Drug|Placebo|Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing either saline 0.9% solution [group 1 (n=30)], ephedrine 0.7 mg/mL [group 2 (n=30)], ephedrine 1 mg/mL [group 3 (n=30)] or ephedrine 1.5 mg/mL [group 4 (n=30)]or phenylephrine 15 mcg/mL [group 5 (n=30)]. All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo and the ephedrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.
16250287|NCT01006252|Drug|Paclitaxel|80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
16250288|NCT01006239|Other|No study intervention|The is no study related intervention.
16250211|NCT01006863|Drug|Phenylephrine|Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing 15 mcg/ml of phenylephrine [group 5 (n=30)] All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo, the ephedrine, and the phenylephrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.
16250212|NCT01006824|Other|Capsule endoscopy|Capsule endoscopy
16250213|NCT01006824|Other|Dedicated small bowel contrast radiography|Dedicated small bowel contrast radiography
16250214|NCT01006811|Dietary Supplement|modified Atkins diet|"Modified Atkins Diet administration
~Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
~Fats (e.g. cream, butter, oils, ghee) encouraged.
~Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
~Clear carbohydrate-fluids not restricted.
~Calcium and multivitamin supplementation will be provided."
16250215|NCT01006811|Other|modified Atkins diet|"Modified Atkins Diet administration
~Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
~Fats (e.g. cream, butter, oils, ghee) encouraged.
~Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
~Clear carbohydrate-fluids not restricted.
~Calcium and multivitamin supplementation will be provided."
16250216|NCT01006798|Other|Placebo|enteric coated capsule containing no vaccine virus
16250217|NCT01006798|Biological|Ad4-H5-Vtn|a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration
16250218|NCT01006798|Biological|Sanofi Pasteur Influenza Virus Vaccine, H5N1|Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
16250219|NCT01006785|Drug|DLBS1425|3 X 150 mg daily for 12 - 16 weeks of treatment
16250220|NCT01006785|Drug|DLBS1425|3 X 300 mg daily for 12 - 16 weeks of treatment
16250221|NCT01006772|Other|Solid Ankle Foot Orthosis|Polypropylene (homopolymer) AFO with carbon fiber reinforcements is provided to experimental group patients as an adjunct therapy to conventional physical therapy.
16250222|NCT01006759|Other|exercise and orientation|guidances for prevention of disability in leprosy with focus on hands, eyes and feet.
16250223|NCT01006746|Other|Remote monitoring by Home Monitoring system|Standard of care completed with remote monitoring for ICD patients follow-up
16250224|NCT01006733|Genetic|Pharmacogenetic|The pharmacogenetic arm estimates therapeutic warfarin dose using cytochrome P 450 2C9 (CYP2C9), vitamin K epoxide reductase complex subunit 1 (VKORC1), and cytochrome P 450 4F2 (CYP4F2) genotype and clinical information. The clinical arm estimates warfarin dose from clinical information alone.
16250225|NCT01006733|Drug|Target INR 1.8|We will randomize patients to a target International Normalized Ratio (INR) of 2.5 or 1.8.
16250226|NCT01006720|Drug|Sugammadex|"Single intravenous injection of either:
~Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)"
16250227|NCT01006720|Drug|Neostigmine|Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
16250228|NCT01006720|Drug|Saline|Saline 0.9% (Saline)
16250229|NCT01006707|Drug|Ondansetron|In this cross-over study, the blinded patient will receive saline placebo in one session and ondansetron in the other. The order is decided with a randomization table. If ondansetron is randomly chosen, an 8mg IV Bolus will be given at the start of the study for 30 minutes by the unblinded investigator.
16250230|NCT01006694|Other|Behavioral Activation + Medication|Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
16250231|NCT01006694|Drug|Guideline Antidepressant Medication|Guideline Antidepressant Medication, following the VN National Mental Health plan.
16250232|NCT01006681|Biological|Focetria (Monovalent MF59-Adjuvanted vaccine)|"7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate
~Intra muscular"
16250233|NCT01006681|Biological|Focetria (Monovalent MF59-Adjuvanted vaccine)|"7.5 mg Hemagglutinin H1/InfluezaA/California/7/2009, 9.75 mg squalene MF59, 1.175 mg polysirate 80, 1.175 mg sorbitan trioleate
~Intramuscular injection"
16250234|NCT01006681|Biological|Focetria (Monovalent MF59-Adjuvanted vaccine)|Monovalent MF59-Adjuvanted vaccine
16250235|NCT01006668|Drug|Administration of sevoflurane|Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
16250236|NCT01006668|Drug|Administration of propofol|Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.
16250237|NCT01006655|Drug|Beclomethasone dipropionate HFA|100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
16250238|NCT01006655|Drug|placebo|inhalation twice a day for one month, preceded and followed by adenosine challenge test
16250239|NCT01006629|Biological|palivizumab|palivizumab 15 mg/kg intramuscularly
16250240|NCT01006616|Drug|Navarixin|Navarixin 10 mg and 30 mg capsules
16250241|NCT01006616|Drug|Placebo|Placebo to navarixin capsules
16250242|NCT01006616|Drug|Rescue medication|Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic
16250243|NCT01006603|Drug|Saxagliptin|5 mg, oral tablet, once daily
16250244|NCT01006603|Drug|Glimepiride|1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
16250245|NCT01006590|Drug|Saxagliptin|5 mg, oral tablet, once daily
16250246|NCT01006590|Drug|Metformin|500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
16250289|NCT01006226|Drug|64Cu-ATSM PET|2 64Cu-ATSM PET scan, one pretreatment and one 19-21 days after the first dose of bevacizumab
16250290|NCT01006213|Behavioral|Motivational intervention|Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group)
16250735|NCT01003366|Device|bevel direction during central venous catheterization|approaching the IJV with the needle bevel facing down
16250247|NCT01006577|Procedure|side-to-end anastomosis|Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon (3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The anastomosis is performed on the antimesenteric aspect of the descending colon. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
16250248|NCT01006577|Procedure|colon j pouch|Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
16250249|NCT01006564|Other|Imaging Investigations (not radiation)|Pre-hormone therapy MRI scans will be performed as an adjunct to the patients' staging MRI scan; post hormone MRI will be done wholly for research purposes.
16250250|NCT01006564|Other|Other|Insertion of gold seeds into prostate for image registration.
16250251|NCT01006551|Drug|Ziprasidone|20mg pills, dosing will be flexible, ranging from 10 to 160 mg divided BID or TID for the duration of the 52 week trial. In very rare cases, if the subject has shown some benefit and no side effects at a dose of 160mg and the treating clinician feels a further dose increase is necessary, the case would need to be presented to all of the other Principal Investigators for special consideration of further dose increases in 20 mg increments to an absolute maximal dose of 220mg.
16250252|NCT01006538|Device|Epimacular Brachytherapy|Strontium-90. The device delivers 24 Gray of beta radiation to the choroidal neovascular membrane (CNV) lesion. Each device is calibrated for a set duration.
16250253|NCT01006538|Drug|Ranibizumab|intravitreal injection of Ranibizumab (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria
16250254|NCT01006525|Drug|zolpidem|placebo or zolpidem (10mg)daily for one year
16250255|NCT01006499|Drug|Pentoxifylline, pentaglobin|Pentaglobin 250mg/kg/d over 4 hour for three days Pentoxyfilline 6mg/kg/h over 4 hour for three days Pentaglobin 250mg/kg/d over 4 hour for three days+Pentoxyfilline 6mg/kg/h over 4 hour for three days Placebo (normal saline 5ml/kg over 4 hour for three days
16250256|NCT01006486|Other|Anticoagulation clinic|Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
16250257|NCT01006486|Other|Standard anticoagulation care|Patients randomized to this arm will be cared by their physician, with standard care. No standardized protocol of the use of coumarins will be established.
16250258|NCT01006473|Other|Exercise training|
16250259|NCT01006460|Drug|Rhodiola rosea, L|3 Capsules twice a day
16250260|NCT01006460|Drug|Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis|3 capsules twice a day
16250261|NCT01006460|Drug|Panax ginseng|3 capsules twice a day
16250262|NCT01006460|Drug|Placebo - dark brown sugar|3 capsules twice a day
16250263|NCT01006447|Behavioral|Instructor contact|
16250264|NCT01006447|Behavioral|Instructor contact|
16250265|NCT01006434|Other|Recording of body weight estimations, approximations and tPA dose|Body weight estimation, patients are weighed, actual tPA dose is recorded
16250266|NCT01006421|Dietary Supplement|GINGKO BILOBA|MEMOREX 60 MG BID
16250267|NCT01006408|Procedure|Low Level Laser|Low Level Laser twice a week for 8 weeks
16250268|NCT01006408|Procedure|Placebo followed by Low Level Laser|Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks
16250269|NCT01006395|Drug|Zoledronic acid|yearly infusion
16250270|NCT01006395|Drug|Placebo|yearly infusion
16250271|NCT01006369|Drug|hydroxychloroquine|hydroxychloroquine 200 mg po BID daily
16250272|NCT01006356|Drug|Hydromorphone HCl OROS|Hydromorphone HCl OROS 8 mg once daily for 2 weeks.
16250273|NCT01006343|Other|Higher Protein (HP)|
16250274|NCT01006343|Other|Lower Protein (LP)|
16250275|NCT01006317|Behavioral|clinical skills training|In addition to financial coverage (CMS) extensive in-service training of clinical skills (CS) to all doctors and MCH workers at the village and township level.
16250276|NCT01006317|Behavioral|health education|In addition to financial coverage extensive in-service training of health education (HE) to all doctors and MCH workers at the village and township level(Anhui, Chongqing and Shaan'xi provinces); In addition to financial coverage extensive in-service training of health education (HE) for Family planning (FP) staff at village level (Anhui).
16250277|NCT01006317|Other|financial|In addition to financial coverage of MCH care within the local reimbursement system (CMS) the coverage of ante- and postnatal care.
16250278|NCT01006304|Drug|JNJ-39439335, Placebo|
16250279|NCT01006291|Drug|insulin degludec|Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
16250280|NCT01006291|Drug|insulin degludec|Injected s.c. (under the skin) once daily. Dose was individually adjusted.
16250281|NCT01006291|Drug|insulin glargine|Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
16250282|NCT01006265|Drug|ACT-128800 Dose 1|ACT-128800 (Dose 1) administered orally once daily
16250283|NCT01006265|Drug|Placebo|Matching placebo administered orally once daily
16250284|NCT01006265|Drug|ACT-128800 Dose 2|ACT-128800 (Dose 2) administered orally once daily
16250285|NCT01006265|Drug|ACT-128800 Dose 3|ACT-128800 (Dose 3) administered orally once daily
16250286|NCT01006252|Drug|Tasisulam-sodium|Administered intravenously on Day 1 of a 28-day cycle, until disease progression.
16251889|NCT00994500|Other|pharmacological study|Correlative studies
16250291|NCT01006187|Drug|Liposomal lidocaine|4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
16250292|NCT01006187|Drug|Vapocoolant spray|medium stream spray on arm for 4-10 seconds prior to injection
16250293|NCT01006187|Other|Rubbing adjacent to the injection site|rubbing adjacent to the injection site before and during injection
16250294|NCT01006187|Other|Distraction|By means of self-selected reading material or video
16250295|NCT01006174|Other|Soybean Oil|Depending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad.
16250296|NCT01006174|Other|Canola Oil|Depending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad.
16250297|NCT01006174|Other|Butter|Depending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad.
16250298|NCT01006161|Drug|SCH 527123|Low dose
16250299|NCT01006161|Drug|SCH 527123|Medium dose
16250300|NCT01006161|Drug|SCH 527123|High dose
16250301|NCT01006161|Drug|SCH 527123|Placebo to match SCH 527123
16250302|NCT01006148|Biological|Allogenix Plus|It is a demineralized bone matrix obtained using cortical or cancellous allograft bone that is treated to remove surface lipids and then dehydrated with ethanol and ethyl esther. It is further processed leaving behind proteins, bone growth factors, and collagen. It is combined with lecithin a which is resistant to breakdown by body fluids. It contains Pro Osteon Implant 500R a naturally derived material made from a non-decorative form of coral, which is subject to a patented thermal process, which converts the coral to hydroxyapatite.
16250303|NCT01006122|Drug|Placebo|Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at 1.0 mg; decrease to 0.5 mg or increase to 2.0 mg based upon the clinicians judgment regarding efficacy and side effects at the 1.0 dose level. The patient will then remain at the determined dose for a 3 week stable dosing period, with a 7 (-2/+ 9) day wash out and then crossover to repeat the same sequence for the second arm of the study.
16250304|NCT01006122|Drug|PF-03654746|Each patient will receive PF-03654746 tablets in a fixed dose titration schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at the 1.0 mg dose; decrease to 0.50 mg or increase to 2.0 mg based upon the clinician's judgement regarding efficacy and side effects at the 1.0 mg dose. The patient will remain at the determined dose for a 3 week stable dosing period.
16250305|NCT01006096|Drug|erlotinib|100mg tablet, once daily for 16 weeks
16250306|NCT01006096|Other|placebo tablet|placebo tablet (lactose), once daily for 16 weeks
16250307|NCT01006070|Procedure|kyphoplasty|surgical kyphoplasty
16250308|NCT01006057|Drug|insulin degludec|Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease
16250309|NCT01006057|Drug|insulin degludec|Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment
16250310|NCT01006057|Drug|insulin degludec|Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment
16250311|NCT01006057|Drug|insulin degludec|Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
16250312|NCT01006057|Drug|insulin degludec|Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment
16250313|NCT01006044|Biological|autologous dendritic cells|Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.
16250314|NCT01006031|Drug|Pegylated interferon alfa-2a and Ribavirin|"Pegylated interferon alfa-2a (360 ug per week) plus oral Ribavirin (800 mg b.i.d.) for 48 or 72 weeks. The treatment will be discontinued for patients who did not achieve a reduction with respect to baseline of at least 0.5 log10 IU/ml in plasma RNA-HCV levels at week 4 or 2 log10 UI/ml at week 12 and will be considered as viral failures.
~Duration: 48 weeks for patients reaching an undetectable plasma RNA_HCV at week12 and 72 weeks for those without a negative viremia at week 12 but a reduction of at least 2 log10 IU/ml in RNA-HCV levels."
16250315|NCT01006018|Drug|Sitagliptin + Pioglitazone PLACEBO|Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
16250316|NCT01006018|Drug|Sitagliptin + Pioglitazone|Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
16250317|NCT01006018|Drug|PLACEBO|Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
16250318|NCT01005992|Procedure|Fractional laser treatment|A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.
16250319|NCT01005992|Procedure|Standard scar management|The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.
16250466|NCT01005251|Drug|lesogaberan (AZD3355)|120 mg, oral, capsules, bid for 4 w
16250467|NCT01005251|Drug|lesogaberan (AZD3355)|180 mg, oral, capsules, bid for 4 w
16250468|NCT01005251|Drug|lesogaberan (AZD3355)|240 mg, oral, capsules, bid for 4 w
16250469|NCT01005251|Drug|Placebo|oral,capsules, bid for 4 w
16250470|NCT01005238|Drug|Lamivudine|
16250471|NCT01005238|Drug|Telbivudine|
16250320|NCT01005979|Drug|Lenalidomide, Rituximab, and Cyclophosphamide|"COHORT 1: Cyclophosphamide 250 mg/m2 day 1, 2 and 3, Rituximab 500 mg/m2 i.v. day 1, Lenalidomide 2.5 mg/day starting day 8-28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
~COHORT 2: Cyclophosphamide 250mg/m2 day 1, 2 and 3. Rituximab 500 mg.m2 i.v. daY Lenalidomide 5 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
~COHORT 3: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 10 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
~COHORT 4: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 15 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
~Patients will receive a total of 6-8 cycles."
16250321|NCT01005966|Drug|Sodium Fluoride Toothpaste|Test product
16250322|NCT01005966|Drug|Amine Fluoride Toothpaste|Test product
16250323|NCT01005966|Drug|Sodium monofluorophosphate/Sodium Fluoride Toothpaste|test product
16250324|NCT01005966|Drug|Placebo|placebo and washout treatment
16250325|NCT01005966|Drug|675 ppmf toothpaste|dose response
16250326|NCT01005940|Device|Mandibular advancement device|Mandibular advancement device made to subject specific specifications
16250327|NCT01005927|Dietary Supplement|Fructooligosaccharide|Zero or 3 g of a fructooligosaccharide will be administered in a beverage containing 300 mg total calcium as well as 15 mg 44Ca (calcium carbonate). Participants will be given one of the above beverages in addition to intravenously receiving 5 mg 43Ca (calcium chloride)in 10 ml saline.
16250328|NCT01005914|Drug|cyclophosphamide|Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
16250329|NCT01005914|Drug|cytarabine|Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4
16250330|NCT01005914|Drug|dexamethasone|Day 1-4; 11-14: 40 mg daily
16250331|NCT01005914|Drug|doxorubicin hydrochloride|Day 4: 50 mg/m2 IV over 2 hours
16250332|NCT01005914|Drug|imatinib mesylate|600 mg/day
16250333|NCT01005914|Drug|methotrexate|Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion
16250334|NCT01005914|Drug|methylprednisolone|Day 1-3: 50mg IV BID
16250335|NCT01005914|Drug|pegaspargase|Day 3/Day4: 2,500 IU/ m2 IV
16250336|NCT01005914|Drug|vincristine sulfate|Day 4 & 11: 2 mg IV
16250337|NCT01005901|Drug|Glycopyrronium bromide|Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)
16250338|NCT01005901|Drug|Placebo|Placebo inhalation capsules were provided for use via a SDDPI
16250339|NCT01005888|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
16250340|NCT01005888|Drug|Placebo (saline)|
16250341|NCT01005875|Drug|Sorafenib|Nexavar in bottles of 120 tables
16250342|NCT01005875|Radiation|Stereotactic Body Radiotherapy (SBRT)|SBRT
16250343|NCT01005862|Biological|PF-04360365|10 mg/kg, single dose administered intravenously
16250344|NCT01005862|Drug|Placebo|Placebo
16250345|NCT01005849|Dietary Supplement|Protecflor|1 Capsule to be taken once a day during the entire study period
16250346|NCT01005849|Dietary Supplement|Placebo|1 Capsule to be taken once a day during the entire study period
16250347|NCT01005836|Behavioral|Cognitive behavioral therapy for youth anxiety|
16250348|NCT01005836|Other|Usual clinic care|
16250349|NCT01005836|Behavioral|Cognitive behavioral treatment for youth depression|
16250350|NCT01005823|Drug|LEO 29102 cream|Twice daily application for 7 days
16250351|NCT01005823|Drug|LEO 29102 placebo cream|LEO 29102 placebo cream
16250352|NCT01005810|Drug|N-Acetylcysteine|1200 mg twice daily for 8 weeks
16250353|NCT01005810|Drug|placebo|2 capsules twice daily for 8 weeks
16250354|NCT01005810|Behavioral|Contingency Management|rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
16250355|NCT01005797|Drug|Panobinostat (LBH589), Sorafenib|Starting dose of sorafenib: 400 mg bid on Day 1-28 of each 28-day cycle; of LBH589: 15 mg on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 of each 28-day cycle. Administered simultaneously.
16250356|NCT01005784|Drug|Cetrorelix (Cetrotide)|flexible antagonist administration according to specified criteria
16250357|NCT01005784|Drug|Cetrorelix (Cetrotide)|fixed antagonist administration on day 6 of ovarian stimulation
16250358|NCT01005771|Drug|GF-001001-00|GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
16250359|NCT01005771|Drug|Placebo|Matching placebo
16250360|NCT01005758|Drug|cyclophosphamide|
16250361|NCT01005758|Drug|cytarabine|
16250362|NCT01005758|Drug|dexamethasone|
16250363|NCT01005758|Drug|doxorubicin hydrochloride|
16250364|NCT01005758|Drug|etoposide phosphate|
16250365|NCT01005758|Drug|hydrocortisone sodium succinate|
16250366|NCT01005758|Drug|imatinib mesylate|
16250367|NCT01005758|Drug|mercaptopurine|
16250368|NCT01005758|Drug|methotrexate|
16250369|NCT01005758|Drug|methylprednisolone|
16250370|NCT01005758|Drug|pegaspargase|
16250371|NCT01005758|Drug|prednisolone|
16250372|NCT01005758|Drug|prednisone|
16250373|NCT01005758|Drug|vincristine sulfate|
16250374|NCT01005758|Other|laboratory biomarker analysis|
16250375|NCT01005758|Radiation|radiation therapy|
16250376|NCT01005745|Procedure|Surgery|Surgery to remove a tumor for growth of TIL
16250377|NCT01005745|Drug|Administration of Lymphodepletion|Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo
16250378|NCT01005745|Other|Adoptive Cell Transfer|T-cell infusion
16250379|NCT01005745|Drug|High Dose IL-2|Beginning approximately 12 - 16 hours after cell infusion.
16250380|NCT01005732|Device|Custom fabricated pressure garments|Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and <5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months
16250381|NCT01005719|Drug|Zegerid|Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.
16250382|NCT01005719|Drug|Prevacid®|Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.
16250566|NCT01004614|Drug|Amlodipine|3rd OD 5 mg tablet single oral dose administered without water
16250383|NCT01005706|Drug|rapamune, mycophenolate mofetil and steroid|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
16250384|NCT01005706|Drug|tacrolimus, sirolimus and steroid|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.
~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
16250385|NCT01005693|Other|questionnaire administration|
16250386|NCT01005693|Procedure|cognitive assessment|
16250387|NCT01005693|Procedure|examination|
16250388|NCT01005693|Procedure|management of therapy complications|
16250389|NCT01005680|Drug|Pemetrexed|500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
16250390|NCT01005680|Drug|Gemcitabine|1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles
16250391|NCT01005680|Drug|Cisplatin|75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
16250392|NCT01005667|Device|BirthTrack|Measurement of cervical dilation and head station
16250393|NCT01005641|Drug|exemestane|25 mg daily
16250394|NCT01005641|Drug|lapatinib|taken orally, daily, at dose recommended after dose finding part of study
16250395|NCT01005628|Drug|bortezomib|Injection into a vein 1.3 mg/m2 twice a week for 21 days
16250396|NCT01005615|Device|Non-FES Upper Extremity Exercise|While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months.
16250397|NCT01005615|Device|RT300-SLSA, from Restorative Therapies, Inc.|They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen
16250398|NCT01005602|Other|Digoxin Dosing per Nomogram|Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis).
16250399|NCT01005602|Drug|Digoxin|All patients included in the trial were treated with digoxin as clinically indicated. The intervention for this study required determining the digoxin dose via a proposed nomogram.
16250400|NCT01005576|Drug|Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan|Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion
16250401|NCT01005563|Other|Beef/Pork|Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein
16250402|NCT01005563|Other|Soy/Legumes|Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.
16250403|NCT01005550|Drug|6 mg of ropivacaine|6 mg of ropivacaine are used for the spinal anaesthesia
16250404|NCT01005550|Drug|8 mg of ropivacaine|8 mg of ropivacaine are used for the spinal anaesthesia
16250405|NCT01005550|Drug|10 mg of ropivacaine|10 mg of ropivacaine for the spinal anaesthesia
16250406|NCT01005550|Drug|12 mg of ropivacaine|12 mg of ropivacaine for the spinal anaesthesia
16250407|NCT01005537|Biological|aldesleukin|Given IV and orally
16250408|NCT01005537|Biological|therapeutic autologous lymphocytes|Given IV
16250409|NCT01005537|Drug|cyclophosphamide|Given IV
16250410|NCT01005511|Device|Grindcare|Active treatment
16250411|NCT01005511|Device|Grindcare - inactive|Placebo treatment
16250412|NCT01005498|Dietary Supplement|Low carbohydrate - high fat diet|The diet has an energy content of 1600 kcal or 1800, with 50% from fat, 20% from carbohydrates and 30% from proteins.
16250413|NCT01005498|Dietary Supplement|High carbohydrate - low fat diet|The diet has an energy content of 1600 or 1800 kcal, with 30% from fat, 55-60% from carbohydrates and 10-15% from proteins.
16250414|NCT01005472|Drug|sunitinib malate|
16250415|NCT01005472|Drug|temozolomide|
16250416|NCT01005459|Drug|Tetracaine|Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
16250417|NCT01005459|Drug|Bupivacaine|Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
16250418|NCT01005446|Device|Encore Reverse Shoulder Prosthesis (RSP®)|The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
16250419|NCT01005433|Drug|Dexmedetomidine|The dexmedetomidine groups (n = 20 for each) will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2, 4, and 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure, when their infusion rate will be decreased by 50% until 20 min after extubation.
16250420|NCT01005433|Drug|Placebo|The placebo group (n = 20) will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, at 30 min before induction of anesthesia. The placebo solution will be looked identical and their infusions will be continued until skin closure, when the infusion rate will be decreased by 50% until 20 min after extubation. The test solution will be prepared by one anesthesiologist before induction of anesthesia.
16250567|NCT01004614|Drug|Amlodipine|2nd OD 5 mg tablet single oral dose administered without water
16251890|NCT00994500|Other|laboratory biomarker analysis|Correlative studies
16250421|NCT01005420|Dietary Supplement|Blueberry Powder|The blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients.
16250422|NCT01005420|Dietary Supplement|Placebo|The blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients.
16250423|NCT01005407|Biological|HEPLISAV and/or Placebo|Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
16250424|NCT01005407|Biological|Engerix-B|Intramuscular (IM) injections on Week 0, Week 4 and Week 24
16250425|NCT01005394|Device|Navigated TMS examination|diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke
16250426|NCT01005381|Dietary Supplement|Small Particle Size Calcium Carbonate Supplement|Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
16250427|NCT01005381|Dietary Supplement|Large Particle Size Calcium Carbonate Supplement|Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
16250428|NCT01005381|Dietary Supplement|Vitamin D|Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
16250429|NCT01005381|Dietary Supplement|Calcium Placebo|"Placebo tablets identical to the large and small particle size calcium carbonate tablets.
~Given twice daily."
16250430|NCT01005368|Genetic|fluorescence in situ hybridization|
16250431|NCT01005368|Genetic|mutation analysis|
16250432|NCT01005368|Genetic|nucleic acid sequencing|
16250433|NCT01005368|Genetic|polymerase chain reaction|
16250434|NCT01005368|Genetic|western blotting|
16250435|NCT01005368|Other|flow cytometry|
16250436|NCT01005368|Other|laboratory biomarker analysis|
16250437|NCT01005355|Biological|IMC-1121B|Cycle 1: Upon completion of enrollment criteria confirmed at screening, the first dose of study medication should be administered within 7 days. The infusion will be planned every 2 weeks or every 3 weeks on the same day of the week of the first infusion. Dose escalation to Cohort 2 may occur in the absence of a dose-limiting toxicity (DLT) in the first three participants treated in Cohort 1 during the initial 6-week dosing period (Cycle 1). The same procedure will be followed for dose escalation from Cohort 2 to Cohort 3. If 1 of 3 participants in any cohort experiences a DLT in the first 6 weeks (Cycle 1), 3 additional participants will be enrolled in that cohort. Dose escalation to the next cohort may occur if less that 2 of 6 participants experience a DLT during Cycle 1.
16250438|NCT01005342|Other|Oat bran|82 g oat bran was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12.6 g total fiber).
16250439|NCT01005342|Other|Spray-dried oat drink|62 g spray-dried oat drink was added to 250 ml blackcurrant beverage with pulp to give 2.7 g soluble fiber (3.3 g total fiber).
16250440|NCT01005342|Other|Rye bran|31 g rye bran was added to 250 ml blackcurrant beverage with pulp to give 1.7 g soluble fiber (12 g total fiber).
16250441|NCT01005342|Other|Sugar beet fiber|19 g sugar beet fiber was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12 g total fiber).
16250442|NCT01005342|Other|Mixture of fiber|38 g spray-dried oat drink, 30 g rye bran and 6 g sugar beet fiber were added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (18 g total fiber).
16250443|NCT01005342|Other|Control|No fiber was added to control meal (250 g black-currant beverage)
16250444|NCT01005329|Biological|Bevacizumab|Given IV
16250445|NCT01005329|Drug|Carboplatin|Given IV
16250446|NCT01005329|Drug|Cisplatin|Given IV
16250447|NCT01005329|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16250448|NCT01005329|Drug|Paclitaxel|Given IV
16250449|NCT01005316|Drug|Induction Therapy|Per standard of care guidelines for immunosuppression at each clinical site.
16250450|NCT01005316|Drug|Tacrolimus|Per standard of care guidelines for immunosuppression at each clinical site.
16250451|NCT01005316|Drug|Mycophenolate Mofetil|Per standard of care guidelines for immunosuppression at each clinical site.
16250452|NCT01005316|Procedure|Intraoperative plasma exchange/pheresis|Per standard of care guidelines for immunosuppression at each clinical site.
16250453|NCT01005316|Procedure|Short-term post-operative plasmapheresis|Per standard of care guidelines for immunosuppression at each clinical site.
16250454|NCT01005316|Drug|Immunoglobulins, Intravenous|Post-transplant course of intravenous immunoglobulin therapy per standard of care guidelines for immunosuppression at each clinical site.
16250455|NCT01005316|Drug|Prednisone|Maintenance corticosteroids per standard of care guidelines for immunosuppression at each clinical site.
16250456|NCT01005303|Drug|Placebo|1 Tablet Daily
16250457|NCT01005303|Drug|Forceval plus 50 micrograms Vitamin D3|Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
16250458|NCT01005290|Drug|Combination pill|A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
16250459|NCT01005290|Drug|Ramipril|A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.
16250460|NCT01005277|Genetic|gene expression analysis|
16250461|NCT01005277|Genetic|microarray analysis|
16250462|NCT01005277|Genetic|polymorphism analysis|
16250463|NCT01005264|Device|non-removable fiberglass|Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus
16250464|NCT01005264|Device|Stabil-D®|Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
16250465|NCT01005251|Drug|lesogaberan (AZD3355)|60 mg, oral, capsules, bid for 4 w
16250472|NCT01005212|Drug|Definity|An intravenous line will be placed and 1.3 mL of the ultrasound contrast agent DEFINITY® will be added to 50 mL sterile saline. Flow will be initiated at 4.0 mL/minute and adjusted for optimal imaging. A maximum of 1.3 mL or one vial of ultrasound contrast will be used per patient per session according to the manufacturer's guidelines.
16250473|NCT01005199|Drug|everolimus|Sorafenib 2 x 400 mg daily plus everolimus 1 x 5 mg daily
16250474|NCT01005199|Drug|sorafenib tosylate|Sorafenib 2 x 400 mg daily
16250475|NCT01005186|Behavioral|Eating habits, diet and exercise|Programme of change to eating habits, diet and exercise
16250476|NCT01005160|Drug|Metformin|CKD-501 0.5mg, metformin 1000mg
16250477|NCT01005160|Drug|CKD-501|CKD-501 0.5mg, metformin 1000mg
16250478|NCT01005147|Drug|tranexamic acid|1 gm every 6 hours for 4 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)
16250479|NCT01005147|Other|Placebo|Will receive placebo treatment as per the tranexamic acid schedule
16250480|NCT01005121|Drug|colchicine|2mg, per-os, once daily for six months
16250481|NCT01005108|Drug|Gabapentin|Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
16250482|NCT01005095|Dietary Supplement|Vitamin D3|Patients will be treated daily with 800 IU of Vitamin D3 by tablets plus a bottle of 75,000 IU vitamin D3 solution every 3 weeks
16250483|NCT01005095|Dietary Supplement|Vitamin D3|Patients will receive 800 IU of vitamin D3 by tablets plus a 3 weekly placebo solution
16250484|NCT01005082|Behavioral|Low salt diet|
16250485|NCT01005082|Behavioral|Water therapy alone|
16250486|NCT01005069|Drug|DLBS-32|DLBS-32 50 mg once daily and lifestyle modification
16250487|NCT01005069|Drug|DLBS-32|DLBS-32 100 mg once daily and lifestyle modification
16250488|NCT01005069|Drug|DLBS-32|DLBS-32 200 mg once daily and lifestyle modification
16250489|NCT01005069|Drug|DLBS-32|DLBS-32 300 mg once daily and lifestyle modification
16250490|NCT01005069|Drug|Placebo capsule|Placebo capsules once daily and lifestyle modification
16250491|NCT01005056|Drug|Ethinylestradiol + Desogestrel|All participants receive Marvelon® according to the approved dosage and administration method.
16250492|NCT01005043|Radiation|heavy ion radiotherapy (C12)|"Desired target of Heavy ion radiotherapy is 60 to 66 Cobalt Gray Equivalent (GyE), whenever possible. It is applied through 1 - 3 isocenter treatment portals. Dose distributions are calculated and dose volume histograms (DVH) are generated. A α/β-ratio of 2 is used for biological plan optimization. Fractionation is planned to be equivalent to 6 x 3 GyE / week. Dosage to organs at risk is minimized. Treatment continues for 20 to 22 days or until one of the following criteria applies:
~Other illness that prevents further administration of treatment, Patient or legal guardian decides to withdraw from the study, or changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator."
16250493|NCT01005030|Other|Blood draw|Blood draw, two tubes, used for isolation of cell-free blood plasma
16250494|NCT01005017|Procedure|Percutaneous Radiofrequent Lesioning|One group receives PRFLSN after a positive trial block with bupivacaine, the other group receives no extra treatment besides optimal medical treatment.
16250495|NCT01005004|Biological|HuCNS-SC cells|intracerebral transplantation
16250496|NCT01004991|Biological|rituximab|375 mg/m2 on Day 8 of each of 6 cycles
16250497|NCT01004991|Drug|cyclophosphamide|750 mg/m2 on Day 8 of each of 6 cycles
16250498|NCT01004991|Drug|vincristine|1.4 mg/m2 on Day 8 of each of 6 cycles
16250499|NCT01004991|Drug|doxorubicin|50 mg/m2 on Day 8 of each of 6 cycles
16250500|NCT01004991|Drug|prednisone|100 mg PO days 8-12 of each of 6 cycles
16250501|NCT01004991|Drug|azacytidine|Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
16250502|NCT01004978|Drug|Cisplatin|Undergo TACE
16250503|NCT01004978|Drug|Doxorubicin Hydrochloride|Undergo TACE
16250504|NCT01004978|Drug|Doxorubicin-Eluting Beads|Undergo TACE
16250505|NCT01004978|Other|Laboratory Biomarker Analysis|Correlative studies
16250506|NCT01004978|Drug|Mitomycin|Undergo TACE
16250507|NCT01004978|Other|Pharmacological Study|Correlative studies
16250508|NCT01004978|Other|Placebo Administration|Given PO
16250509|NCT01004978|Drug|Sorafenib Tosylate|Given PO
16250510|NCT01004965|Other|laboratory biomarker analysis|
16250511|NCT01004952|Behavioral|screening questionnaire|Phase I involves in-home interviews of 25 participants to understand the factors that affect participants' decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing). In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use an electronic narrative diary to record their daily behaviors about UVR protection. They will be asked to carry a interactive voice response (IVR) system for 14 days and they should be in the continental United States.
16250512|NCT01004939|Drug|fondaparinux|fondaparinux
16250513|NCT01004926|Device|Echelon foot|One Echelon foot for each subject, for a period of a month.
16250514|NCT01004900|Procedure|Selective Laser Trabeculoplasty|This is a laser procedure used to treat glaucoma by reducing the pressure in the eye. SLT works by using laser light to stimulate the body's own healing response to lower your eye pressure. Using a special wavelength and energy, the laser affects only pigmented (melanin containing) cells of your eye. SLT improves the flow of fluid in the eye, which in turn lowers your eye pressure.
16250515|NCT01004900|Drug|Travoprost/ Timolol/ Azopt/ Brimonidine|Travoprost (Topical eye drops) administered once daily before sleep
16250516|NCT01004887|Other|diagnostic laboratory biomarker analysis|
16250517|NCT01004874|Drug|Bevacizumab|Bevacizumab (Avastin) at 10 mg/kg every other week during standard radiation therapy (XRT). Following XRT, bevacizumab will remain at 10 mg/kg every other week.
16250518|NCT01004874|Drug|Temozolomide|Daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation therapy (XRT). Following XRT, temozolomide will be dosed at 150 mg/m2 daily the first 5 days of each 28-day cycle.
16250519|NCT01004874|Radiation|Radiation Therapy (XRT)|Standard radiation therapy for approximately 6.5 weeks
16250731|NCT01003418|Biological|Prevenar|Routine infant immunisation vaccine, three doses administered intramuscularly
16250520|NCT01004874|Drug|Topotecan|Following standard radiation therapy, patients will receive topotecan on days 2 through 6 of each 28-day cycle at a dose of 1.5 mg/m2 for patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs) and 2.0 mg/m2 for patients taking EIAEDs.
16250521|NCT01004861|Drug|PLX3397|Capsules administered once or twice daily, continuous dosing
16250522|NCT01004848|Behavioral|Peer-Led Lifestyle Education on Weight Loss|Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes. It consists of 8 sessions (1½ hours each) held over 10-weeks. Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.
16250523|NCT01004822|Drug|CVX-241|0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250524|NCT01004822|Drug|CVX-241|1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250525|NCT01004822|Drug|CVX-241|3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250526|NCT01004822|Drug|CVX-241|6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250527|NCT01004822|Drug|CVX-241|12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250528|NCT01004822|Drug|CVX-241|15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250529|NCT01004822|Drug|CVX-241|18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250530|NCT01004822|Drug|CVX-241|25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
16250531|NCT01004809|Drug|Dutasteride|Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16250532|NCT01004796|Genetic|cytogenetic analysis|
16250533|NCT01004796|Genetic|microarray analysis|
16250534|NCT01004796|Genetic|mutation analysis|
16250535|NCT01004796|Other|immunohistochemistry staining method|
16250536|NCT01004796|Other|immunologic technique|
16250537|NCT01004796|Other|mass spectrometry|
16250538|NCT01004783|Genetic|DNA methylation analysis|
16250539|NCT01004783|Genetic|gene expression analysis|
16250540|NCT01004783|Genetic|loss of heterozygosity analysis|
16250541|NCT01004783|Genetic|microarray analysis|
16250542|NCT01004783|Genetic|mutation analysis|
16250543|NCT01004783|Genetic|polymerase chain reaction|
16250544|NCT01004783|Genetic|reverse transcriptase-polymerase chain reaction|
16250545|NCT01004783|Other|laboratory biomarker analysis|
16250546|NCT01004770|Drug|GE-145 (AN113111) Injection|40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration.
16250547|NCT01004770|Drug|Visipaque (iodixanol) Injection|An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
16250548|NCT01004757|Other|LOGI diet|diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled aerobic exercise for three weeks
16250549|NCT01004757|Other|Low Fat diet|traditional low fat diet based on 55% mixed glycemic index carbohydrates, 20% protein and 25% fat for three weeks followed by LOGI diet for two weeks, always combined with heart rate controlled aerobic exercise
16250550|NCT01004744|Drug|Anastrozole|1mg PO daily for two weeks prior to scheduled surgery
16250551|NCT01004731|Drug|Cetuximab in combination with Carboplatin/Gemcitabine|A loading dose of Cetuximab (400 mg/m2 IV over 120 minutes) will be administered 1 week prior to chemotherapy. Thereafter, Cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each new cycle of therapy, Carboplatin will be infused with Gemcitabine (Days 1 and 8). Patients will be evaluated for a tumor response following every two cycles of therapy. In the absence of progressive disease, patients may continue to receive additional therapy.
16250552|NCT01004718|Radiation|Fludeoxyglucose F18|Undergo FDG PET/CT scans
16250553|NCT01004718|Procedure|Computed Tomography|Undergo FDG PET/CT scans
16250554|NCT01004718|Procedure|Positron emission tomography|Undergo FDG PET/CT scans
16250555|NCT01004705|Drug|Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),|A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
16250556|NCT01004705|Drug|Simvastatin|A once daily oral dose of simvastatin for 12 weeks.
16250557|NCT01004692|Device|Occlusal splints|The splint will be a hard acrylic-resin stabilization appliance to wear in the upper jaw. The OSS does not come in contact with the gums of the patient and does not act as an orthodontic device. The OSS will be used only for the three nights in a row, of the ambulatory-PSG recording with the OSS in situ.
16250558|NCT01004653|Biological|H1N1 influenza A Vaccine (Split virion), Inactivated|100 elders were assigned to receive one dose of 15μg H1N1 influenza A Vaccine (Split virion), Inactivated
16250559|NCT01004640|Genetic|DNA analysis|
16250560|NCT01004640|Genetic|Southern blotting|
16250561|NCT01004640|Genetic|cytogenetic analysis|Correlative studies
16250562|NCT01004640|Genetic|polymerase chain reaction|
16250563|NCT01004627|Procedure|Arterial and venous duplex ultrasound examination|Ultrasound mapping of all blood vessels in the upper limb of interest
16250564|NCT01004614|Drug|Amlodipine|3rd OD 5 mg tablet single oral dose administered with water
16250565|NCT01004614|Drug|Amlodipine|2nd OD 5 mg tablet single oral dose administered with water
16250732|NCT01003405|Drug|KUC-7483|
16250568|NCT01004601|Drug|docetaxel|patients at one university-affiliated hospital received low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)following failure of previous treatment stage IIIb/IV NSCLC.
16250569|NCT01004601|Drug|pemetrexed|patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.
16250570|NCT01004588|Dietary Supplement|Protein drink|total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks
16250571|NCT01004588|Dietary Supplement|placebo drink|subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.
16250572|NCT01004575|Device|implantation of Kaname Cobalt-Chromium coronary stent|implantation of Kaname Cobalt-Chromium coronary stent
16250573|NCT01004562|Other|informational intervention|
16250574|NCT01004536|Device|silicone gel|twice daily application onto designated half of cesarean section wound for 12 weeks
16250575|NCT01004536|Other|no treatment|left untreated during the study period
16250576|NCT01004523|Genetic|fluorescence in situ hybridization|
16250577|NCT01004523|Genetic|loss of heterozygosity analysis|
16250578|NCT01004523|Genetic|polymerase chain reaction|
16250579|NCT01004523|Other|flow cytometry|
16250580|NCT01004523|Other|immunohistochemistry staining method|
16250581|NCT01004510|Drug|zoledronic acid|Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
16250582|NCT01004497|Drug|Dasatinib|After the completion of each induction and consolidation chemotherapy with recovery of leukocyte and platelet counts, dasatinib will be given as an alternative manner: 100 mg by mouth once daily for 4 weeks
16250583|NCT01004497|Drug|Cyclophosphamide|300 mg/m2, IV for 2 hours, every 12 hours x 6 doses, days 1-3
16250584|NCT01004497|Drug|Vincristine|1.4 mg/m2/day (maximum 2 mg/day), IV for 30 minutes, days 4 & 11
16250585|NCT01004497|Drug|Daunorubicin|45 mg/m2/day, IV for 1 hour, days 4 & 11
16250586|NCT01004497|Drug|Dexamethasone|40 mg/day, IV push, days 1-4 & days 11-14
16250587|NCT01004497|Drug|Cytarabine|2 g/m2, IV for 3 hours, every 12 hours x 10 doses, days 1-5
16250588|NCT01004497|Drug|Mitoxantrone|12 mg/m2/day, IV for 30 minutes, days 1-2
16250589|NCT01004484|Other|A probiotic yogurt with inulin|A 4 oz. cup with a probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving), once daily.
16250590|NCT01004484|Other|Acidified dairy snack|A 4 oz. cup of acidified dairy snack, once daily.
16250591|NCT01004458|Behavioral|Cognitive behavioral therapy|The treatment, adopted to reduce hostility and stress behavior, was given during group sessions once a week during six months with two follow-up occasions during the next six months
16250592|NCT01004458|Other|Waiting list|The group served as referents during the trial and received no intervention other than measurements at the same points in time as the intervention group
16250593|NCT01004445|Drug|Amikacin (BAY41-6551)|Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
16250594|NCT01004445|Drug|Amikacin (BAY41-6551)|Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
16250595|NCT01004445|Drug|Placebo|Two aerosol treatments per day (one treatment every 12hr)
16250596|NCT01004432|Drug|Golimumab 50 mg SC|Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
16250597|NCT01004432|Drug|Golimumab 2 mg/kg IV|Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.
16250598|NCT01004432|Drug|Methotrexate (MTX)|Participants will continue taking their current Methotrexate (MTX) treatment regimen.
16250599|NCT01004432|Drug|Placebo SC|Placebo matched to golimumab SC injection every 4 weeks.
16250600|NCT01004432|Drug|Placebo IV|Placebo matched to golimumab intravenous infusion every 8 weeks.
16250601|NCT01004419|Drug|ZD6474 (vandetanib)|vandetanib (100 mg or 200 mg or 300 mg) by mouth once daily for 28 days
16250602|NCT01004419|Drug|Faslodex (Fulvestrant)|Fulvestrant 500 mg intra-muscular injection on Day 1 and 250 mg Day 15 of cycle 1 Cycles 2 and beyond: Fulvestrant 500 mg intra-muscular injection on Day 1, every 28 days.
16250603|NCT01004406|Device|intensive LDL-lowering therapy|The intensive LDL-lowering therapy uses LDL-apheresis in addition to the standard statin therapy. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks
16250604|NCT01004406|Drug|standard statin monotherapy|The standard statin therapy of 40-80mg oral daily dose of Atorvastatin or other equivalent types of statin to lower LDL in blood for both randomized groups.
16250605|NCT01004393|Drug|Methylnaltrexone bromide|Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
16250606|NCT01004380|Drug|Farletuzumab, Carboplatin, and PLD|All subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.
16250607|NCT01004367|Other|Experimental|Environmental- and individual based components carried out in the school.
16250608|NCT01004367|Other|No intervention|No intervention carried out in the school
16250609|NCT01004354|Drug|Ergocalciferols|2000 international units by mouth daily for 8 weeks.
16250610|NCT01004341|Behavioral|Family-based behavioral weight control intervention|Standard behavioral weight control program for children ages 8-12 years old and their parents in a family-based intervention.
16250611|NCT01004328|Other|Intervention 1: Electronic medical record (EMR)-based transitional care intervention|Electronic delivery of enhanced discharge information to the ambulatory physician with plans for follow-up appointment, notice of any new medications, and recommendations for laboratory monitoring
16250612|NCT01004315|Drug|KUC-7483|
16250613|NCT01004315|Drug|Placebo|
16250614|NCT01004315|Drug|Tolterodine|
16250615|NCT01004302|Procedure|ventral capsular/ventral striatal gamma capsulotomy|Comparison of active radiosurgical with sham radiosurgeries
16250616|NCT01004289|Procedure|Postconditioning|Primary angioplasty and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion
16250617|NCT01004289|Procedure|Primary angioplasty and stenting without additional intervention|Primary angioplasty and stenting without additional intervention.
16250618|NCT01004276|Other|New, improved smoking cessation management module|The intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS. This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts.
16250619|NCT01004263|Drug|rizatriptan benzoate|Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack
16250620|NCT01004250|Drug|Pemetrexed|500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity.
16250621|NCT01004250|Drug|Cisplatin|75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles
16250622|NCT01004250|Drug|Bevacizumab|7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity
16250623|NCT01004237|Drug|pravastatin, valsartan, pravastatin+valsartan|pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
16250624|NCT01004224|Drug|BGJ398|
16250625|NCT01004211|Procedure|Narrow band imaging transurethral resection|Transurethral resection of bladder lesion by mean of narrow band imaging
16250626|NCT01004211|Procedure|Standard transurethral resection|Transurethral resection of bladder lesion by mean of standard white light
16250627|NCT01004198|Drug|MP4OX|4.3 g/dL PEG-Hb solution in lactated electrolyte solution
16250628|NCT01004198|Drug|MP4OX|4.3 g/dL PEG-Hb solution in lactated electrolyte solution
16250629|NCT01004198|Drug|Ringers Lactate solution|Ringers Lactate solution for Injection
16250630|NCT01004185|Drug|Asacol 400 mg|17-33kg = 3 Asacol 400mg AM & 2 Asacol 400mg PM; 33-<54kg = 5 Asacol 400 mg AM & 4 Asacol 400mg PM; 54-<90kg = 6 Asacol 400mg AM & PM
16250631|NCT01004185|Drug|Asacol 400 mg|17-<33kg = 2 Asacol 400mg & 1 placebo AM, 1 Asacol 400mg & 1 placebo PM; 33-<54kg = 3 Asacol 400mg & 2 placebo AM, 2 Asacol 400mg & 2 placebo PM; 54-<90kg = 3 Asacol 400mg & 3 placebo AM & PM
16250632|NCT01004172|Drug|carboplatin|
16250633|NCT01004172|Drug|bevacizumab|
16250634|NCT01004172|Drug|herceptin|
16250635|NCT01004159|Drug|cetuximab with irinotecan|Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
16250636|NCT01004146|Procedure|Incentive Spirometry|helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
16250637|NCT01004120|Dietary Supplement|Bimuno|5.5g daily intake
16250638|NCT01004120|Dietary Supplement|Maltodextrin|5.5g daily intake
16250639|NCT01004107|Device|Radiesse Injectable Dermal Filler|Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
16250640|NCT01004094|Behavioral|simple goal setting|This group will set goals only
16250641|NCT01004094|Behavioral|goal setting plus action intentions|This group will set goals and form action intentions (plans)
16250642|NCT01004094|Behavioral|goal setting plus coping intentions|This group will set goals and form coping intentions (plans)
16250643|NCT01004094|Behavioral|goal setting plus action intentions plus coping intentions|This group will set goals and form action intentions and coping intentions
16250644|NCT01004081|Drug|BIIB021|BID orally for 28 days
16250645|NCT01004081|Drug|BIIB021|TIW orally for 28 days
16250646|NCT01004081|Drug|exemestane (Aromasin)|Daily in tablet form for 28 days
16250647|NCT01004068|Other|SET-diet plus clomiphene|Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate
16250648|NCT01004068|Drug|Clomiphene citrate|Clomiphene citrate at 150 mg daily for one cycle
16250649|NCT01004068|Behavioral|Structured exercise program plus hypocaloric diet|SET plus diet
16250650|NCT01004055|Device|Procellera™ Antimicrobial Wound Dressing|Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed
16250651|NCT01004055|Drug|ACTICOAT™ Antimicrobial Barrier Dressing|Dressing changes every 2-3 days, more frequently if needed
16250652|NCT01004055|Drug|Mepilex® Ag Silver Foam Dressing|Dressing changes every 2-3 days, more frequently if needed
16250653|NCT01004042|Drug|Botulinum Toxin Type A|Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
16250654|NCT01004029|Drug|Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL|1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
16250655|NCT01004029|Drug|Vehicle|Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
16250656|NCT01004016|Drug|KPS-0373|
16250657|NCT01004016|Drug|Placebo|
16250658|NCT01004003|Drug|Sorafenib|
16250659|NCT01004003|Drug|BIBF 1120|Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data
16250660|NCT01003990|Drug|Atazanavir|Tablets, Oral, 400 mg, once daily, indefinitely
16250661|NCT01003990|Drug|Atazanavir/Ritonavir|Tablets, Oral, 300/100 mg, once daily, indefinitely
16250662|NCT01003990|Drug|Tenofovir/Emtricitabine|Tablets, Oral, 300/200 mg, once daily, indefinitely
16250663|NCT01003990|Drug|Lopinavir/ritonavir|Tablets, Oral, 400/100 mg, twice daily, indefinitely
16250664|NCT01003964|Drug|Irinotecan, Cisplatin, Gemcitabine, Pemetrexed, Docetaxel|"GP:
~Gemcitabine (1250 mg/m2) IV on day1, 8. Cisplatin (75 mg/m2) IV on day1 every 3 weeks
~IP:
~Irinotecan (65 mg/m2) IV on day 1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks
~2nd or 3rd: Pemetrexed (500 mg/m2) D1 with premedication every 3 weeks Docetaxel (75 mg/m2) D1 with premedication every 3 weeks"
16250665|NCT01003951|Procedure|Acupuncture|"Acupuncture treatments will be given at the Integrative Medicine Outpatient Center, if needed in particular cases, at the MSKCC Breast Center. Each treatment is 30-40 minutes in duration. Each patient will receive two acupuncture treatments each week for four consecutive weeks.
~Before and after each treatment, the circumference of the patient's upper arm, and forearm will be measured in both the affected and unaffected arms. The greater difference between affected and unaffected arms (either the forearm or the upper arm) for each patient will be used for outcome assessment. Photographs of the patient's affected and unaffected arms before and after each treatment will be taken to provide visual documentation of status. The patient's face will not appear in the photographs. Blood draws will be performed from the unaffected arm in serum collection tubes and will be performed within 1 week of starting acupuncture and within 1 week of completion of the 4 week protocol."
16250666|NCT01003938|Drug|Topotecan|
16250667|NCT01003938|Drug|Erlotinib|
16250668|NCT01003925|Behavioral|Standard of care for osteoarthritis treatment|Standard of care educational materials to inform patients about choices for knee pain.
16250669|NCT01003925|Behavioral|Conjoint Analysis for Osteoarthritis|Conjoint Analysis computer software to inform patients about choices for knee pain.
16250670|NCT01003912|Biological|ALD-601|ALD-601 is manufactured by Aldagen from the 20% compartment of the selected umbilical cord blood unit within 24 hrs of planned injection. A dose of ALD-601 that delivers 1 x 105 - 2 x 106 cells/kg of estimated fetal weight at day - 1 is suspended in 300 microliters of dialysis media.
16250671|NCT01003899|Drug|afatinib (BIBW 2992)|afatinib (BIBW 2992) po QD
16250672|NCT01003886|Drug|Doxazosin mesylate GITS|Doxazosin mesylate GITS 4mg to 8mg once daily
16250673|NCT01003873|Biological|Evaluation of the endocannabinoid system|The evaluation of the endocannabinoid system consist in the determination of plasma concentration of the 2 main endocannabinoids (2AG and AEA) before (5 blood samples) and after (5 blood samples) after consumption of a calibrated food. As a comparator, ghrelin will be measured at the same time.
16250674|NCT01003873|Procedure|Biopsy of visceral and peripheral adipose tissue|The endocannabinoids will be also determined in adipose tissue. Biopsy of visceral and peripheral adipose tissue will be done during surgery and peripheral adipose tissue will be done 6 months after surgery.
16250675|NCT01003873|Biological|Evaluation of metabolic parameters|The evaluation of the metabolic status consist in evaluation of body composition (DEXA), determination of visceral adiposity (CT scan) and measurement of plasma lipids, glucose, insulin, leptin, adiponectin.
16250676|NCT01003873|Behavioral|Evolution of behavioral parameters|The behavioral evaluation will de done with different questionnaires: ORWELL 97, HAD scale, Three Factor Eating Questionnaire, Beck Depression inventory, Questionnaire of personality TCI.
16250677|NCT01003873|Behavioral|Dietician consultation|The evaluation of the metabolic status will also be seen by a dietician.
16250678|NCT01003873|Behavioral|Psychologist consultation|The behavioural evaluation will de done with a psychologist consultation
16250679|NCT01003847|Drug|fenofibrate, fatty acid, placebo|fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment
16250680|NCT01003834|Behavioral|Computerized brief intervention|Intervention based on Motivational Interviewing technique
16250681|NCT01003834|Behavioral|Computerized health screening|Behavioral intervention
16250682|NCT01003834|Behavioral|Computerized assessment|Behavioral intervention
16250683|NCT01003834|Behavioral|Therapist-delivered motivational intervention|Behavioral intervention
16250684|NCT01003808|Biological|IMF-001|100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject).
16250685|NCT01003769|Drug|Lenalidomide|Given PO
16250686|NCT01003769|Drug|R-(-)-Gossypol Acetic Acid|Given PO
16250687|NCT01003769|Other|Laboratory Biomarker Analysis|Correlative studies
16250688|NCT01003756|Other|Preoperative neuromuscular exercise|A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
16250689|NCT01003743|Device|endolumenal tissue approximation|
16250690|NCT01003730|Other|Ventilator settings|Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
16250691|NCT01003704|Procedure|Lower extremity amputation|
16250692|NCT01003691|Biological|RN6G|Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
16250693|NCT01003691|Biological|Placebo|Intravenous, multiple dose with experimental dose
16250694|NCT01003678|Drug|Clofarabine|"Dose Escalation Schedule - Level 1: 1 mg daily x 5 days (orally) followed by 23 days off drug.
~Levels 2, 3, 4 and 5 are: 3, 5, 10 and 15 mg daily x 5 days followed by 23 days off drug."
16250695|NCT01003652|Procedure|thyroidectomy|Comparison between two groups of patients. One group is operated on using harmonic Focus for haemostasis compared to a second group of patients operated on with the conventional haemostasis using tie-and-clamp technique
16250696|NCT01003639|Drug|Acetazolamide|Subjects will begin with four 250 mg tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
16250697|NCT01003639|Drug|Placebo|Subjects will begin with four tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
16250698|NCT01003639|Behavioral|Formal weight loss counselling program|Teleconference, web-based from central location, using site visits and subject self-assessment tools
16250733|NCT01003379|Drug|TC-5619|TC-5619-238 will be provided as hard gelatin capsules in strengths of 1mg, 5mg, and 25mg.
16250734|NCT01003379|Drug|Placebo|Placebo will be provided with exactly the same shape, size and appearance.
16250699|NCT01003626|Procedure|Tumor Interstitial Fluid Pressure (IFP) assessments|The tip of a needle will be inserted in a skin lesion (similar to a biopsy needle) for up to 3 tumors. The needle is connected to a machine that reads the pressure inside the tumor. The whole process, including cleaning and numbing the lesion, will take about 3-4 minutes.
16250700|NCT01003626|Device|Transducer-catheter SPC-320 + Amplifier|Transducer-tipped catheter Mikro-Tip SPC-320 and transducer Millar with Power Lab used to assess the interstitial fluid pressure in a malignant melanona nodule
16250701|NCT01003613|Drug|Tranilast, and Tissucol|1.0%, 0.1 ml, subconjunctival route, single dose
16250702|NCT01003613|Other|Beriplast P|0.1 ml to attach graft
16250703|NCT01003600|Behavioral|Questionnaire|The questionnaire will be administered by telephone and will take approximately 20-30 minutes. The questionnaire will elicit survivor responses along five domains: knowledge about diagnosis and treatment, knowledge about ongoing risks and recommended testing, history of health care utilization since the end of treatment, preferences for relevant information about these topics, and employment after the end of cancer treatment.
16250704|NCT01003587|Behavioral|District health information package|"The intervention package consists of:
~A report on disease burden, disease control priorities and health system performance in India
~Condensed fact sheet based on the report
~District health report cards (DRCs) comparing performance on key health indicators with other districts, information on causes of death in each district, and actionable messages to reduce deaths in the district
~Customized speech for district level officials detailing key actions to reduce deaths
~Reminder materials including poster version of the DRCs and video on key points and actionable messages"
16250705|NCT01003574|Behavioral|lifestyle modification and telephone counseling|A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
16250706|NCT01003574|Behavioral|lifestyle modification and telephone counseling|Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.
16250707|NCT01003561|Procedure|spinal anesthesia for surgery|spinal anesthesia (T10) for elective TURP surgery
16250708|NCT01003548|Device|SMART dynamic system of embryo culture|Embryos will be cultured in a dynamic system of microfluidics.
16250709|NCT01003548|Device|Static culture|Embryos cultured in 40 microliters microdrops of G-IVF plus series V
16250710|NCT01003522|Other|Arterial puncture|Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure.
16250711|NCT01003522|Other|Venepuncture|Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists.
16250712|NCT01003522|Procedure|General anaesthetic|Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.
16250713|NCT01003522|Procedure|Inpatient stays|Patients randomised into the stenting arm will be admitted overnight for the procedure
16250714|NCT01003522|Other|Walking test|All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent
16250715|NCT01003522|Other|Spirometry & flow volume loop assessment|All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.
16250716|NCT01003522|Other|Biopsy material|For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics.
16250717|NCT01003509|Procedure|modified shouldice and double|one arm modified shouldice, other one is double repair
16250718|NCT01003496|Behavioral|Treatment as Usual (TAU)|Outpatient substance abuse treatment
16250719|NCT01003496|Behavioral|TAU + Long-Term Recovery Management|Long-Term Recovery Management (LTRM) combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. Patients randomly assigned to LTRM will be asked to participate in group sessions each month for 12 months.
16250720|NCT01003483|Drug|orlistat|Tablet,120mg,three times a day,three months
16250721|NCT01003470|Other|acupuncture|Xing Nao Kai Qiao Acupuncture
16250722|NCT01003470|Behavioral|rehabilitation|Kinesitherapy
16250723|NCT01003470|Other|acupuncture and rehabilitation|Xing Nao Kai Qiao Acupuncture plus Kinesitherapy
16250724|NCT01003457|Other|ultrasonography|transvaginal ultrasonography of bladder wall thickness
16250725|NCT01003444|Procedure|Muscle biopsy|Collection of muscle biopsies of the vastus lateralis will be performed by a consulting specialist. The first muscle biopsy (Day 1, 2 hour) will be obtained from the vastus lateralis muscle of the non-dominant leg. The second biopsy (Day 1, 4 hour) will be obtained from the same vastus lateralis muscle on the same leg approximately 10 centimeters from the first muscle biopsy site.
16250726|NCT01003431|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
16250727|NCT01003431|Biological|Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)|Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
16250728|NCT01003431|Biological|Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)|Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.
16250729|NCT01003418|Biological|GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine|Two doses; intramuscular administration
16250730|NCT01003418|Biological|Infanrix™-IPV/Hib|Routine infant immunisation vaccine, three doses administered intramuscularly
16253471|NCT00983944|Drug|prednisone|Given IV or orally
16250736|NCT01003366|Device|bevel direction during central venous catheterization|approaching the IJV with the needle bevel facing up
16250737|NCT01003353|Behavioral|Maximal strength training|Training will be carried out 3 times a week for 8 weeks. Each session will include a warm up, strength training and warm down. The total time will be approximately 1 hour. The training will consist 2 exercises (leg press and plantarflexion). Participants will train each leg individually with 4 sets of 4 repetitions at 90% of the 1 repetition maximum.
16250738|NCT01003340|Behavioral|Wee Wheezers|The intervention, Wee Wheezers, modified to the needs of the targeted population will include 6 bi-weekly 1 hour educational home visits conducted by Community Health Workers at homes of children with persistent asthma
16250739|NCT01003327|Device|I-gel|intubation with I-gel airway
16250740|NCT01003327|Device|LMA-Unique|LMA-Unique airway is inserted first, then the I-gel
16250741|NCT01003314|Biological|AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine|Group 1A: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM. Group 1B: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later
16250742|NCT01003314|Biological|AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge|Group 2A: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM. Group 2B: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later. Group 2C: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later and subsequent sporozoite malaria challenge 12-28 days post second vaccination
16250743|NCT01003301|Drug|Omalizumab|Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
16250744|NCT01003301|Drug|Placebo|Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
16250745|NCT01003288|Biological|Adjuvanted influenza H1N1split virion vaccine|"Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)
~* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
16250746|NCT01003275|Drug|Paricalcitol|Two 1 mcg soft gels by mouth daily for 8 weeks
16250747|NCT01003275|Drug|Placebo|Two soft gels by mouth daily for 8 weeks
16250748|NCT01003262|Other|Emergency Department Observation Protocol|The EDOSP will consist of cardiac enzyme testing, 12-24 hours of cardiac monitoring, and echocardiogram testing by explicit criteria
16250749|NCT01003262|Other|Unstructured, inpatient evaluation|This is unstructured management by an inpatient medical team.
16250750|NCT01003249|Drug|Baclofen|"Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). After the 3 week washout period, questionnaires, diary, EMG and uroflowmetry will be repeated. Then patients initially assigned to the baclofen group will be assigned to the placebo group, and those assigned to the placebo group will be assigned to the baclofen group.
~Patients would then receive a dose of baclofen 10 mg PO twice daily (or placebo twice daily), and then the dose will be escalated to 80 mg."
16250751|NCT01003249|Drug|Placebo|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen). After the 3 week washout period, questionnaires, diary, EMG and uroflowmetry will be repeated. Then patients initially assigned to the baclofen group will be assigned to the placebo group, and those assigned to the placebo group will be assigned to the baclofen group.
~Patients would then receive a dose of baclofen 10 mg PO twice daily (or placebo twice daily), and then the dose will be escalated to 80 mg."
16250752|NCT01003236|Drug|placebo|140 mg placebo tablets, 3 times per day for 3 months
16250753|NCT01003236|Drug|Milk Thistle extract|1 tablet equal to 140mg silymarin administered 3 times a day for 3 months
16250754|NCT01003223|Other|Computer algorithm management of hyperphosphatemia|The PKM algorithm is a computer based program that calculates Phosphorus intake between dialysis, phosphorus reduction during dialysis treatment and daily oral phosphate binder intake compliance. Based on pre and post dialysis serum phosphorus levels, the algorithm makes recommendations in relation to dialysate calcium, oral phosphate binder use, and dietary counseling.
16250755|NCT01003210|Drug|Hyland's earache drops|3-4 drops in affected ear 3 times a day as needed for up to 5 days
16250756|NCT01003184|Drug|exenatide once weekly|subcutaneous injection, 2mg, once a week
16250757|NCT01003184|Drug|insulin detemir|subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
16250758|NCT01003171|Drug|MCS-2 soft-gel capsule|MCS-2 30 mg/day
16250759|NCT01003158|Drug|AZD8931|Tablet Oral bid
16250760|NCT01003158|Drug|Paclitaxel|IV once weekly for 3 weeks followed by a week off
16250761|NCT01003145|Biological|Influenza A (H1N1) 2009 monovalent vaccine, inactivated|
16250762|NCT01003132|Other|Acceptance and Commitment Therapy|Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
16250763|NCT01003119|Behavioral|Addiction CHESS|Smartphone with ACHESS application loaded onto the phone.
16250764|NCT01003106|Drug|Ranibizumab 0.5mg (monthly)|Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
16250765|NCT01003106|Drug|Ranibizumab 2.0mg (monthly)|
16250766|NCT01003106|Drug|Pro re nata (prn) ranibizumab|
16250767|NCT01003106|Procedure|Pro re nata (prn) Laser photocoagulation|
16250768|NCT01003093|Biological|50 microgram antigen (Ag85B + ESAT-6)|0.5 mL suspension for injection x 2 with 2 months interval
16250769|NCT01003093|Biological|50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a|0.5 mL suspension for injection x 2 with 2 months interval
16250770|NCT01003093|Biological|50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a|0.5 mL suspension for injection x 2 with 2 months interval
16250885|NCT01002183|Drug|Fosmidomycin|450 mg capsules, every 12 hrs for 3 days
16250771|NCT01003080|Device|Aquamantys Device|The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
16250772|NCT01003080|Other|Standard of care treatment for hemostasis during a total knee arthroplasty.|"The active comparator arm will receive the standard-of-care for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device."
16250773|NCT01003067|Device|Mesh implementation|Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
16250774|NCT01003054|Drug|Busulfan|130 mg/m^2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -7 to -4)
16250775|NCT01003054|Drug|Cyclophosphamide|60 mg/kg in 500 ml of normal saline over 4 hours on each of 2 consecutive days (day -3, -2)
16250776|NCT01003054|Drug|Imatinib Mesylate|Starting dose 100 mg/day (mg/d), escalated to maximal dose of 400 mg/d as tolerated, after day 28 when Absolute neutrophil count (ANC) is >1500/mcl and platelets >50,000 /mcl, may be titrated to maintain ANC >1.0 and platelets >50,000 /mcl.
16250777|NCT01003054|Procedure|Autologous Stem Cell Transplantation|Stem Cell Infusion: Unpurged hematopoietic stem cells administered intravenously on day 0.
16250778|NCT01003028|Drug|Remifentanil (Limited) - Target Controlled Infusion system|Limit max plasma concentration to 9.8 ng/ml
16250779|NCT01003028|Drug|Remifentanil (Control) - Target Controlled Infusion system|Use 20 ng/ml as max plasma concentration
16250780|NCT01003015|Drug|BAY73-4506|160 mg BAY73-4506
16250781|NCT01003002|Drug|Levodopa (delivered intravenously)|One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.
16250782|NCT01002989|Device|Doppler Ankle-Brachial Index measurement|Measurement of the Ankle-Brachial Index by Doppler.
16250783|NCT01002989|Device|WatchBP Office Ankle-Brachial Index measurement.|Measurement of Ankle-Brachial Index by WatchBP Office device.
16250784|NCT01002963|Drug|PF-04418948|solution, 30 mg, single
16250785|NCT01002963|Drug|PF-04418948|solution, 100 mg, single
16250786|NCT01002963|Drug|PF-04418948|solution, 300 mg, single
16250787|NCT01002963|Drug|PF-04418948|solution, 1000 mg, single
16250788|NCT01002963|Drug|PF-04418948|solution, 3000 mg, single
16250789|NCT01002963|Drug|PF-04418948|solution, 4500 mg, single
16250790|NCT01002963|Drug|PF-04418948|solution, 6000 mg, single
16250791|NCT01002950|Drug|ACU-4429|ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
16250792|NCT01002950|Drug|Matching placebo|Matching placebo tablets taken orally once daily for 90 days
16250793|NCT01002924|Drug|EC145|EC145 will be administered intravenously at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4.
16250794|NCT01002911|Drug|Cefazolin, Bacitracin, Cefalexin|Single does of Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision, Bacitracin wash, Cefalexin 250-500 mg TID
16250795|NCT01002911|Drug|Cefazolin|Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision
16250796|NCT01002898|Drug|lopinavir/ritonavir soft gel capsule|Ritonavir-boosted lopinavir in soft gel formulation at 400/100 mg and lamivudine at 150 mg were given twice daily.
16250797|NCT01002872|Drug|Lanthanum Carbonate|Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill BID. If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner
16250798|NCT01002872|Drug|Fosrenol|Initial dose of drug will be 1500mg TID
16250799|NCT01002872|Drug|placebo|Initial dose of placebo will be 1 pill three times a day
16250800|NCT01002859|Drug|Sandimmum|Intravenous injection of cyclosporine
16250801|NCT01002859|Drug|Placebo|Intravenous Injection of NaCl solution
16250802|NCT01002846|Procedure|acupuncture|acupuncture group : subject will undergo 20minute sessions twice a week for 8weeks. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted up to 1 cm depth sham acupuncture group : subject will undergo 20 minute. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted under 1 cm slightly.
16250803|NCT01002833|Biological|Exposure to Plasmodium falciparum infected mosquitoes|Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes
16250804|NCT01002820|Drug|ganaxolone|liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
16250805|NCT01002807|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Single Dose
16250806|NCT01002807|Drug|Metformin XR|Tablets, Oral, 1000 mg, Single Dose
16250807|NCT01002807|Drug|Glucophage|Tablets, Oral, 1000 mg, Single Dose
16250808|NCT01002794|Procedure|Arthroscopic partial menisectomy|Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.
16250809|NCT01002794|Other|Supervised neuromuscular and strength training|Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.
16250810|NCT01002781|Drug|Tocilizumab|Tocilizumab, IV, 8 mg/kg, every 2 weeks
16250811|NCT01002768|Drug|insulin degludec|Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
16250812|NCT01002768|Drug|insulin glargine|Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
16250813|NCT01002755|Drug|Lenalidomide|Given PO
16250814|NCT01002755|Biological|Ofatumumab|Given IV
16250815|NCT01002742|Drug|Mycophenolate Mofetil|"Oral dosing should be delivered in 250 mg units. For those < 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period.
~Patients who weight > 60 kg should receive MMF 1 gm PO/IV every 8 hours.
~Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours.
~Patients who weight <40 kg should receive 20 mg/kg IV or PO every 8 hours."
16250886|NCT01002157|Dietary Supplement|Menaquinone-7 (Vitamin K2)|Menaquinone-7 (Vitamin K2)
16250816|NCT01002742|Drug|Placebo|"Oral dosing should be delivered in 250 mg units blinded placebo. For those < 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period.
~Patients who weight > 60 kg should receive placebo 1 gm PO/IV every 8 hours.
~Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours.
~Patients who weight <40 kg should receive 20 mg/kg IV or PO every 8 hours."
16250817|NCT01002729|Other|Patients with a BMI < 30 given Oseltamivir|Patients with a BMI < 30 given Oseltamivir
16250818|NCT01002729|Other|Patients with a BMI > 40 given Oseltamivir|Patients with a BMI > 40 given Oseltamivir
16250819|NCT01002716|Biological|Agrippal S1 (Influenza vaccination)|Single dose of vaccine
16250820|NCT01002703|Drug|Lenalidomide, Bendamustine, Prednisone|During the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine.
16250821|NCT01002690|Drug|Etoricoxib|90 mg/day orally for 10-13 days
16250822|NCT01002677|Behavioral|Advocacy training curriculum|Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
16250823|NCT01002677|Behavioral|Self-directed|Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.
16250824|NCT01002664|Drug|MCS-2|30 mg/day (two 15 mg capsules) Qd for 12 weeks
16250825|NCT01002664|Drug|Placebo|2 soft-gel placebo capsules Qd for 12 weeks
16250826|NCT01002651|Dietary Supplement|wheat bran extract|soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner
16250827|NCT01002651|Dietary Supplement|placebo|soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner
16250828|NCT01002638|Other|TEGADERM®|It consists of the occlusive application of two Tegaderm®, a plastic dressing
16250829|NCT01002638|Procedure|Surgery|It consists of pulp reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy).
16250830|NCT01002625|Drug|PF-04457845 / matched placebo|PF-04457845 4 mg tablet once daily / matched placebo
16250831|NCT01002625|Drug|PF-04457845 / matched placebo|PF-04457845 4 mg tablet once daily / matched placebo
16250832|NCT01002599|Device|Boussignac TM CPAP|Post-operative patients will be fitted with a Boussignac TM CPAP mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period.
16250833|NCT01002599|Device|Venturi Face Mask|Post-operative patients will be fitted with a Venturi face mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period.
16250834|NCT01002586|Other|Wii-Fit intervention|Half hour daily, five days a week, for 8 weeks
16250835|NCT01002586|Other|Walking exercise program|walking exercise program
16250836|NCT01002573|Drug|ibuprofen|Ibuprofen, 10 mg/kg
16250837|NCT01002573|Drug|acetaminophen|Acetaminophen, 10mg/kg
16250838|NCT01002547|Drug|pioglitazone-placebo|This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm following completion of the baseline measurements and continued on placebo for the rest of the clinical trial.
16250839|NCT01002547|Drug|pioglitazone|Pioglitazone will be started on 30 mg/day, titrated to the maximal dose (45 mg/day) at two months and continued at this dose for the rest of the clinical trial.
16250840|NCT01002547|Dietary Supplement|Vitamin E|All participants will receive vitamin E 400 IU orally twice daily.
16250841|NCT01002547|Drug|pioglitazone-placebo|This is a RCT in which all patients will be educated on a -500 kcal/day diet and a healthy lifestyle. Depending on randomization, subjects adjudicated to placebo will be started at the same time as the active (pioglitazone) arm following completion of the baseline measurements and continued on placebo for the rest of the clinical trial.
16250842|NCT01002547|Dietary Supplement|Vitamin E|All participants will receive vitamin E 400 IU orally twice daily.
16250843|NCT01002547|Drug|Vitamin E-placebo|Placebo of vitamin E will be given to arm 3.
16250844|NCT01002534|Drug|Vardenafil|Nasal instillation of Vardenafil
16250845|NCT01002534|Drug|Placebo|Nasal instillation of placebo matching in appearance with the Vardenafil instillation
16250846|NCT01002508|Biological|Influenza vaccine|One dose of influenza vaccine
16250847|NCT01002495|Biological|VM202|Endocardial injections on Day 0.
16250848|NCT01002482|Device|CGAO-based Glucose Control|"Use of a clinical computerized decision-support system named CGAOtm designed to achieve tight glucose control in various ICU settings, and fine-tuned to reduce glucose variability without increasing the incidence of severe hypoglycemia or nurse workload.
~CGAOtm is based on explicit replicable recommendations following each blood glucose measurement for insulin rates and time to next measurement, and reminders, alerts, graphic tools, trends, and individual on-line data aimed at increasing confidence of the nursing staff in the computer protocol and giving care staff a method for controlling the process during the whole ICU stay, according to a human-in-the-loop approach.
~The algorithm used in the CGAOtm software for the calculation of the recommended insulin rates derived from a PID (Proportional-integral-derivative) controller, a generic control loop feedback mechanism widely used in industrial control."
16250849|NCT01002482|Device|Standard-Care Glucose Control|"Patients in the control group will receive conventional insulin therapy using the usual care protocol of each participating centre (already used in the centre before the beginning of the trial and targeting blood glucose levels inferior to 180 mg/dl)."
16250850|NCT01002469|Other|sodium [1-13C] acetate|
16250851|NCT01002456|Other|Level 1: (provide site-specifi information)|provide site-specific information on non-adherence to guideline
16250852|NCT01002456|Other|Level 2 (Provide site- and patient-specific information)|provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
16250853|NCT01002443|Drug|Helicobacter pylori eradication|Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
16250854|NCT01002443|Drug|placebo|Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days
16250887|NCT01002157|Other|Placebo capsules|Capsules containing no Menaquinone-7
16250888|NCT01002144|Other|blood sampling|
16250855|NCT01002430|Biological|VEGF-D gene transfer|Gene transfer will be performed by using endocardial injection system (NOGATM) and an escalating dose of 1x109, 1x1010 and 1x1011 vpu of AdVEGF-D will be injected into 10 sites of the myocardium (0.2 ml per site).
16250856|NCT01002417|Drug|MCS-2 15 mg/day|One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
16250857|NCT01002417|Drug|MCS-2 30 mg/day|Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
16250858|NCT01002417|Drug|Placebo|Two matching placebo soft-gel capsules, oral daily for 12 weeks.
16250859|NCT01002404|Procedure|angled and straight tipped guide wire|Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.
16250860|NCT01002391|Procedure|reduction mammaplasty|Dressing following reduction mammaplasty is removed on the first postoperative day
16250861|NCT01002391|Procedure|reduction mammaplasty|Dressing following reduction mammaplasty is removed on the sixth postoperative day
16250862|NCT01002378|Drug|Regorafenib (Stivarga, BAY73-4506)|A single dose of regorafenib will be administered immediately following a high fat breakfast
16250863|NCT01002378|Drug|Regorafenib (Stivarga, BAY73-4506)|A single dose of regorafenib will be administered immediately following a low fat breakfast
16250864|NCT01002378|Drug|Regorafenib (Stivarga, BAY73-4506)|A single dose of regorafenib will be administered following an overnight fast
16250865|NCT01002365|Other|Oxygen delivery|
16250866|NCT01002365|Other|Oxygen administration|
16250867|NCT01002339|Drug|Tacrolimus with rapid steroid withdrawal|"Basiliximab induction (4 mg i.v., days 0 and 4).
~Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7.
~Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
~Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d."
16250868|NCT01002339|Drug|Tacrolimus with steroids minimization|"Basiliximab induction (4 mg i.v., days 0 an 4)
~Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
~Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
~Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d."
16250869|NCT01002339|Drug|CsA with steroid minimization|"Basiliximab induction (4 mg i.v., days 0 an 4)
~Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
~CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml.
~Mycophenolate mofetil 1 gr b.i.d"
16250870|NCT01002326|Behavioral|Cognitive-Behavioral Therapy|20 sessions of Cognitive-Behavioral Therapy
16250871|NCT01002300|Drug|intranasal oxytocin|Participants will receive 24 IU of oxytocin or placebo (Salinex saline nasal spray) intranasally 30 minutes prior to completing the experimental tasks. Two weeks later participants will return for a second visit and receive the alternate drug (either intranasal oxytocin or Salinex) prior to completing the experimental tasks.
16250872|NCT01002287|Device|SprayShield Adhesion Barrier System|Adhesion Barrier Device
16250873|NCT01002287|Procedure|Good Surgical Technique Alone|Good Surgical Technique Alone
16250874|NCT01002274|Drug|MCS-2|2 soft-gel capsules Qd for 40 weeks
16250875|NCT01002248|Drug|Perifosine|Perifosine will be dosed as one 50 mg pill every day of each cycle.
16250876|NCT01002248|Drug|Perifosine Placebo|Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
16250877|NCT01002248|Drug|Bortezomib|Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
16250878|NCT01002248|Drug|Dexamethasone|Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
16250879|NCT01002235|Biological|VM202|Intramuscular injections in the calf on Day 0 and Day 14.
16250880|NCT01002222|Drug|MCS-2|15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.
16250881|NCT01002209|Procedure|Hyperbaric Oxygen treatment (HBO)|"HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask).
~HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital."
16250882|NCT01002209|Procedure|Sham HBO|"HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital.
~For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min airbrakes will also be included."
16250883|NCT01002196|Behavioral|Stimulus fading procedures|"Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety (stimulus fading and reward).
~2. Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents.
~3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic.
~4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child).
~5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM"
16250884|NCT01002196|Behavioral|Guidance on defocused communication|Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months
16250889|NCT01002131|Device|CBCT|Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings.
16250890|NCT01002118|Drug|Omega-3 Acid Ethyl Esters|1 gram capsules Omega-3 Acid Ethyl Esters for a total of 4 grams (4 capsules) per day for 16 weeks
16250891|NCT01002118|Drug|Placebo|4 capsules each day for 16 weeks
16250892|NCT01002105|Drug|Baclofen|Baclofen 50mg per day for 12 weeks and psychosocial intervention
16250893|NCT01002105|Other|Control group|psychosocial intervention and placebo for 12 weeks
16250894|NCT01002092|Drug|Chemotherapy|Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).
16250895|NCT01002092|Drug|Endostar|In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day
16250896|NCT01002079|Drug|BMS-708163|Capsule, Oral, 125 mg, Once daily, 1 day
16250897|NCT01002079|Drug|Rifampin|Capsule, Oral, 600 mg, Once daily, 7 days
16250898|NCT01002079|Drug|Rifampin|Capsule, Oral, 600 mg, Once daily, 6 days
16250899|NCT01002053|Procedure|Nerve conduction study and Ultrasound of the PTN|Nerve Conduction studies and ultrasound of PTN will be performed to the patient before the operation and 8 weeks postoperatively.
16250900|NCT01002040|Biological|Arepanrix|Group A receives one dose of Arepanrix
16250901|NCT01002040|Biological|Arepanrix|Group B receives 2 doses of Arepanrix 3 weeks apart
16250902|NCT01002027|Behavioral|CBT-Counselling|Intervention entailed six sessions of counselling-CBT delivered either by a trained Nurse, or by a Psychologist. Sessions focussed on: psycho-education about PND, main issues of concern, assessment of symptom severity, problem solving. Behavioural interventions (pleasant activities, anxiety management, relaxation, relationship communication) were used together with cognitive interventions (understanding links between thoughts and feelings, increasing positive thoughts, challenging negative self-talk and unhelpful beliefs).
16250903|NCT01002014|Procedure|Nipple Sparing Mastectomy|Skin sparing mastectomy with preservation of the nipple areolar complex
16250904|NCT01001988|Other|Blood sample|Blood sample for immunogenicity assessment
16250905|NCT01001988|Biological|JE-CV administered in Study JEC02|Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05
16250906|NCT01001975|Drug|Sunscreen Test Code: V53-028|Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
16250907|NCT01001975|Drug|Sunscreen Test Code: V53-030|Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone
16250908|NCT01001975|Drug|Standard SPF 4 Sunscreen|8% Homosalate Standard SPF 4 Sunscreen
16250909|NCT01001962|Drug|empagliflozin|ACTIVE TREATMENT FOR DIABETES
16250910|NCT01001962|Drug|Metformin|ACTIVE TREATMENT FOR DIABETES
16250911|NCT01001949|Dietary Supplement|Wheat Bran Extract|soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner
16250912|NCT01001949|Dietary Supplement|placebo|soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
16250913|NCT01001936|Drug|SKI-606|
16250914|NCT01001923|Drug|REGN475/SAR164877|"Pharmaceutical form: solution
~Route of administration: intravenous infusion over 30 minutes"
16250915|NCT01001923|Drug|Placebo (for REGN475/SAR164877)|"Pharmaceutical form: solution
~Route of administration: intravenous infusion over 30 minutes"
16250919|NCT01001897|Drug|Misoprostol|400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
16250920|NCT01001897|Drug|Placebo|400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
16250921|NCT01001884|Other|caregiver psychoeducational consultation program (CPCP)|6-session caregiver psychoeducational consultation program (CPCP)
16250922|NCT01001871|Dietary Supplement|Sprinkles®|powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months
16250923|NCT01001871|Dietary Supplement|vitamin/mineral fortificant without iron|powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months
16250924|NCT01001858|Other|Diagnosis and monitoring of OSA patients|The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
16250925|NCT01001845|Drug|Milk Thistle extract|1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
16250926|NCT01001845|Drug|vit E|200 mg twice daily for 3 weeks
16250927|NCT01001845|Drug|vit E + Milk Thistle extract|200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks
16250928|NCT01001832|Drug|Intravenous (IV) abatacept|IV vial, 125-mg infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141.
16250929|NCT01001832|Drug|Subcutaneous (SC) abatacept|Solution in prefilled syringes, SC, 125 mg, once weekly, for 169 days and then for 52 weeks
16250930|NCT01001806|Drug|Ketorolac Tromethamine 0.45%|One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
16250931|NCT01001806|Drug|bromfenac 0.09%|One day pre operative 1 drop BID then 3 doses pre op day of surgery
16250932|NCT01001806|Drug|nepafenac 0.1%|One drop BID, 1 day pre operative and then 3 doses the day of surgery
16250933|NCT01001793|Device|Levacor Ventricular Assist Device|Surgical procedure
16250934|NCT01001780|Drug|Pentostatin; Cyclophosphamide; Rituximab|Pentostatin 2mg/m2 IV day+1 (up to 6 cycles) Cyclophosphamide 600mg/m2 IV day+1 (up to 6 cycles) Rituximab 375mg/m2 IV day+1 (up to 6 cycles)
16250935|NCT01001767|Drug|Lovaza|Lovaza one gram twice a day for 24 weeks
16250936|NCT01001767|Drug|Placebo|Placebo
16250937|NCT01001754|Drug|PEG-rIL-29|Weekly SC injections in combination with ribavirin for up to 48 weeks
16250938|NCT01001754|Drug|Peginterferon alfa-2a|Weekly SC injections in combination with ribavirin for up to 48 weeks
16250939|NCT01001754|Drug|Ribavirin|Daily oral administration (400-600 mg BID)
16250979|NCT01001429|Drug|propofol|propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
16250940|NCT01001741|Other|Cell phone text message|We will use cellular text messages to remind patients of impending drug prescription refills and scheduled visits to their healthcare provider.
16250941|NCT01001728|Radiation|Imaging investigations (with radiation)|
16250942|NCT01001715|Drug|REGN475/SAR164877|"Pharmaceutical form: solution
~Route of administration: intravenous infusion over 30 minutes"
16250943|NCT01001715|Drug|Placebo (for REGN475/SAR164877)|"Pharmaceutical form: solution
~Route of administration: intravenous infusion over 30 minutes"
16250944|NCT01001702|Drug|Aripiprazole|Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
16250945|NCT01001689|Behavioral|Nutritional counseling + exercise groups|Two telephone consultations on nutritional topics and twice weekly exercise groups. Access to a password-protected internet site with information on healthy lifestyle during pregnancy. Two evening meetings with information on healthy pregnancy lifestyle.
16250946|NCT01001676|Device|Percutaneous Transluminal Angioplasty (PTA)|Angioplasty with the use of Conventional balloon
16250947|NCT01001676|Device|Paclitaxel Eluting Balloon Angioplasty|Angioplasty with the use of paclitaxel eluting balloon
16250948|NCT01001663|Device|FemoSeal®|Closure device for femoral artery access closure
16250949|NCT01001663|Other|Manual compression|Conventional manual compression
16250950|NCT01001650|Biological|Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)|"Group 1: 4 doses of 7,500 PfSPZ/immunization,
~Group 2: 4 doses of 30,000 PfSPZ/immunization,
~Group 3: 4 doses of 135,000 PfSPZ/immunization, and
~Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization.
~If > 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will receive a fifth and sixth dose."
16250951|NCT01001637|Dietary Supplement|Curcumin Formulation|2000mg or 3000mg daily BID
16250952|NCT01001637|Dietary Supplement|Placebo|Placebo
16250953|NCT01001624|Other|Melanil facial cream|Dosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream.
16250954|NCT01001624|Other|Hydroquinone 2% cream|Dosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream.
16250955|NCT01001611|Drug|CKD-501 0.5mg|0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)
16250956|NCT01001611|Drug|Placebo|Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks
16250957|NCT01001598|Drug|danazol|Dosage is done according to weight; capsules are 50, 100, 200 mg
16250958|NCT01001585|Drug|sevoflurane|During induction, concentration of inspired sevoflurane will begin at .5%, and slowly increased by 0.5% every two minutes, until a Bispectral Index (BIS) of 60 or less is reached, which will take approximately 10 minutes.
16250959|NCT01001572|Drug|Valsartan/amlodipine 160/5 mg|Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
16250960|NCT01001572|Drug|Valsartan 160 mg|Valsartan 160 mg capsule taken orally once daily.
16250961|NCT01001572|Drug|Placebo|1 capsule or tablet taken orally once daily
16250962|NCT01001559|Drug|L-methylfolate|Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily
16250963|NCT01001559|Drug|Selective serotonin reuptake inhibitor (SSRI)|Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
16250964|NCT01001559|Drug|Serotonin and norepinephrine reuptake inhibitor (SNRI)|Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
16250965|NCT01001546|Behavioral|Internet-based|Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
16250966|NCT01001546|Behavioral|Standard Clinic-Based|Veterans randomized to the control condition will have a consult placed to the Durham VA Medical Center (DVAMC) specialty Smoking Cessation Clinic placed on their behalf.
16250967|NCT01001520|Drug|Tolcapone|"Participants will be asked to take study medication each day for both 11-day study medication periods.
~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
16250968|NCT01001520|Drug|Placebo|"Participants will be asked to take study medication each day for both 11-day study medication periods.
~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
16250969|NCT01001507|Procedure|Integrated family planning/HIV care and treatment services|Family planning services will be provided during the patient's HIV care visit.
16250970|NCT01001494|Drug|Aclidinium bromide 200 μg bid|Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
16250971|NCT01001494|Drug|Aclidinium bromide 400 μg bid|Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
16250972|NCT01001494|Drug|Placebo|Placebo twice-daily by inhalation for 24 weeks
16250973|NCT01001481|Other|Risk status for medication adherence|Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia
16250974|NCT01001468|Drug|VB-201|Single daily dose of oral VB-201 20 mg
16250975|NCT01001468|Drug|VB-201|Single daily dose or oral VB-201 80 mg
16250976|NCT01001468|Other|Placebo|Single daily dose of oral placebo
16250977|NCT01001442|Drug|BT062|intravenous administration
16250978|NCT01001429|Drug|Dexmedetomidine infusion|bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
16253472|NCT00983944|Drug|vincristine sulfate|Given IV or orally
16250980|NCT01001403|Drug|Nafamostat|0.2 mg/kg as bolus 1 minute before reperfusion
16250981|NCT01001403|Drug|Normal saline|10 ml of normal saline
16250982|NCT01001390|Device|AFO Device|Ankle Foot Orthoses impact on net oxygen consumption.
16250983|NCT01001377|Drug|Cetuximab|Administered by intravenous infusion
16250984|NCT01001377|Drug|Panitumumab|Administered by intravenous infusion
16250985|NCT01001364|Drug|Formoterol/Budesonide|formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
16250986|NCT01001364|Drug|Foraseq|formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
16250987|NCT01001351|Drug|PRT-201|Applied topically during surgery.
16250988|NCT01001351|Drug|Placebo|Applied topically during surgery
16250989|NCT01001338|Drug|RDEA594|Uricosuric agent for the treatment of gout.
16250990|NCT01001338|Drug|Placebo|Matching Placebo
16250991|NCT01001338|Drug|Allopurinol|Allopurinol
16250992|NCT01001325|Biological|Fluviral influenza vaccine, 2009-2010|0.5 mL intramuscular
16250993|NCT01001325|Biological|Normal saline|0.5 mL intramuscular
16250994|NCT01001312|Other|Daxor Blood Volume Analysis|Radiolabeled albumin for direct measurement of blood volume
16250995|NCT01001312|Other|Clinical volume status assessment|Volume assessment based on history and physical examination
16250996|NCT01001299|Drug|Drug cocktail|Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20
16250997|NCT01001299|Drug|RO5185426|960 mg orally twice daily
16250998|NCT01001286|Behavioral|Questscope Non-Formal Education|"Participation in two-hour classes for three to five days per week. Duration involves 24 months of programming (three, eight-month learning cycles), but this randomized controlled trial will only assess impacts of participation in the first four months.
~Regular presence of trained, supportive adults. Educational topics and class activities determined by the youth as a group with the support of the adult teachers (facilitators)."
16250999|NCT01001273|Other|Hyperinsulinemic Normoglycemic Clamp|The patient receives insulin intravenous infusion at 2ml units/kg/min. Dextrose 20% (D20W ®) will be titrated to maintain blood glucose between 4 - 6 mmol/L (72 - 108 mg/dl).
16251000|NCT01001260|Drug|No ASA|Alternative antiplatelet therapy instead of aspirin
16251001|NCT01001260|Drug|Low dose ASA|Low dose aspirin (81mg) prior to PTCA
16251002|NCT01001260|Drug|325 mg ASA|high dose of aspirin prior to PTCA
16251003|NCT01001247|Drug|TMC278; Omeprazole|
16251004|NCT01001234|Drug|rizatriptan|"For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity).
~Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet."
16251005|NCT01001234|Drug|placebo|For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.
16251006|NCT01001234|Drug|rizatriptan|"For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
~Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet."
16251007|NCT01001234|Drug|placebo|For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
16251008|NCT01001221|Drug|cabazitaxel|"Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion
~Route of administration: Intravenous infusion over 60 minutes
~Dosage:
~Study part 1: 15, 20 or 25 mg/m^2 according to pre-defined dose escalation schedule
~Study part 2: MTD as determined in Study part 1"
16251009|NCT01001221|Drug|gemcitabine|"Pharmaceutical form: According to United States Package Insert (USPI)
~Route of administration: Intravenous infusion over 30 minutes
~Dosage:
~Study part 1: 700, 900 or 1000 mg/m^2 according to pre-defined dose escalation schedule
~Study part 2: MTD as determined in Study part 1."
16251010|NCT01001208|Drug|Methotrexate|Methotrexate tablets over-encapsulated for blinding
16251011|NCT01001208|Drug|Etanercept|1 mL for subcutaneous injection
16251012|NCT01001208|Drug|Placebo|Matching placebo to methotrexate capsules
16251013|NCT01001195|Drug|AGN-210669 ophthalmic solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
16251014|NCT01001195|Drug|AGN-210669 ophthalmic solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
16251015|NCT01001195|Drug|AGN-210669 ophthalmic solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
16251016|NCT01001195|Drug|bimatoprost ophthalmic solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
16251017|NCT01001182|Other|non interventional|non interventional
16251018|NCT01001169|Biological|GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)|Two intramuscular injections
16251019|NCT01001156|Other|Comparison of different breathing muscular training|Three times per week for ten weeks, thirty minutes.
16251020|NCT01001143|Drug|Decitabine|
16251021|NCT01001143|Drug|Bexarotene|
16251022|NCT01001130|Drug|fluticasone furoate group|patients who are administered fluticasone furoate at least once
16251023|NCT01001117|Device|LensAR laser surgery|Use of laser for cataract surgery
16251024|NCT01001117|Device|Phaco-emulsification cataract surgery|Phaco-emulsification cataract surgery
16254200|NCT00978549|Procedure|nausea and vomiting therapy|
16251025|NCT01001104|Drug|LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
16251026|NCT01001104|Drug|Placebo|Administered by SC injection, QW for 12 weeks.
16251027|NCT01001091|Drug|AL-38583 ophthalmic solution|
16251028|NCT01001091|Drug|AL-38583 ophthalmic solution vehicle|Inactive ingredients used as a placebo comparator
16251029|NCT01001091|Drug|Dexamethasone ophthalmic suspension, 0.1%|
16251030|NCT01001078|Device|I-Gel supraglottic airway device|2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.
16251031|NCT01001078|Device|LMA Supreme supraglottic airway device|In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
16251032|NCT01001078|Device|Standard endotracheal tube|In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted
16251033|NCT01001065|Procedure|Vascular ultrasound|RI ist predictive for arteriosclerosis
16251034|NCT01001052|Drug|Colcrys™ (colchicine)|0.6 mg taken by mouth on day 1
16251035|NCT01001026|Biological|Arepanrix|Adults: One dose Arepanrix vaccine given IM (0.5 mL)
16251036|NCT01001026|Biological|Arepanrix|Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
16251037|NCT01001013|Drug|LC15-0444, Pioglitazone|LC15-0444 200 mg (100 mg x 2) qd (12 days once daily) Pioglitazone 30 mg (15 mg x 2) qd (12 days once daily) LC15-0444 200 mg (100 mg x 2) qd + pioglitazone 30 mg (15 mg x 2) qd (12 days once daily)
16251038|NCT01001000|Procedure|Ultrasound (Pressure measurement)|cut-off value for non maturationg fistulas
16251039|NCT01000987|Drug|varenicline|1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.
16251040|NCT01000987|Drug|placebo|placebo
16251041|NCT01000974|Biological|GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)|Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.
16251042|NCT01000974|Biological|ActHIB™|Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
16251043|NCT01000974|Biological|Pentacel™|Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
16251044|NCT01000974|Biological|Pediarix™|Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
16251045|NCT01000974|Biological|Prevnar 13™|Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
16251046|NCT01000974|Biological|Rotarix™|Two oral doses in primary epoch at 2 and 4 months of age
16251047|NCT01000974|Biological|Engerix™-B|Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection
16251048|NCT01000974|Biological|Infanrix™|One dose in the booster epoch at 15-18 months of age as intramuscular injection
16251049|NCT01000961|Drug|Cystagon® (Cysteamine Bitartrate)|"Run-in Period (Weeks 1, 2, 3) and Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:
~Every 6H, supplied in 150 and 50mg capsules/Duration of Treatment: 3 weeks each period used"
16251050|NCT01000961|Drug|Cysteamine Bitartrate Delayed-release Capsules (RP103)|"Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:
~Every 12H, supplied in 75 and 25mg capsules/Duration of Treatment: 3 weeks"
16251051|NCT01000948|Drug|ZD4054|ZD4054 10 mg given orally, once daily in tablet form to all patients in two years or until investigator consider the drug for useless.
16251052|NCT01000935|Other|Platelet Rich Plasma|Patient's blood will be drawn prior to the start of the procedure. The processing disposable (PD) size of 60ml will be used to yield 7 ml of Platelet concentrate volume. Using the lateral portal, the applicator for the PRP will be positioned in between the bone and the repaired rotator cuff without a cannula. The inflow will then be closed and the arthroscopic fluid will be aspirated via the outflow cannula. All other cannulae will be removed, producing a dry subacromial space. The PRP and autologous thrombin will then be transferred to the sterile field and drawn up into a dedicated spray applicator kit (Smartjet) and applied to the site of repair. A dry arthroscopic check will be performed to evaluate the clot formation of the applied solution.
16251053|NCT01000922|Drug|Regular Human Insulin|Individual dose of RHI administered subcutaneously
16251054|NCT01000922|Drug|Lispro|Individual dose of lispro administered subcutaneously
16251055|NCT01000922|Drug|VIAject|Individual dose of VIAject administered subcutaneously
16251056|NCT01000922|Drug|VIAject 50%|Individual dose of VIAject 50% administered subcutaneously
16251057|NCT01000922|Drug|VIAject/Insulin Glargine|VIAject mixed wiht insulin glargine and administered subcutaneously
16251058|NCT01000922|Drug|Insulin Glargine/VIAject|Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously
16251059|NCT01000909|Procedure|Ultrasound (venous pressure measurement)|increased venous pressure is predictive for chronic venous insufficiency
16251060|NCT01000896|Drug|AZD0530|film coated tablet, PO, daily
16251061|NCT01000896|Drug|Carboplatin|intravenous, 3 weeks
16251062|NCT01000896|Drug|paclitaxel|intravenous, 3 weeks
16251063|NCT01000883|Other|biologic sample preservation procedure|approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
16251064|NCT01000883|Other|laboratory biomarker analysis|Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
16251065|NCT01000883|Procedure|biopsy|cancer tissue will be taken from the primary breast cancer site as well as the metastatic tumor sites. Two tubes of whole blood will also be collected.
16251066|NCT01000870|Drug|MNI-513-01|Subjects will be administered a single IV injection of IMP with a total activity amounting to 300MBq (8.1 mCi) +/- 20% of MNI-513 followed by PET imaging.
16251067|NCT01000857|Drug|Paroxetine CR and Paroxetine IR|Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers
16251068|NCT01000831|Biological|adjuvanted Arepanrix|Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
16251069|NCT01000818|Drug|MK0518 (Raltegravir)|400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
16251070|NCT01000818|Drug|famotidine|Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
16251071|NCT01000818|Drug|omeprazole|20 mg oral tablet of omeprazole, once daily for 5 days
16251072|NCT01000805|Drug|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
16251073|NCT01000805|Drug|Placebo|Participants received placebo QD, po for 8 weeks.
16251074|NCT01000792|Drug|Levocetirizine|The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride). 28 film tablets will be dispensed. Oral intake should be performed once daily (administration in the evening).
16251075|NCT01000792|Drug|Levocetirizine|Levocetirizine
16251076|NCT01000779|Drug|Propranolol|upto 320mg/day maximum
16251077|NCT01000779|Device|multi band ligator for esophageal varices|to obliterate esophageal varices
16251078|NCT01000753|Other|Cytology Specimen Collection Procedure|Correlative studies
16251079|NCT01000740|Genetic|EGFR Mutation Test|Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
16251080|NCT01000740|Genetic|Ki-67 protein expression|Ki-67 protein expression in tissue will be analysed by IHC method.
16251081|NCT01000727|Drug|Darapladib 160 mg|Lp-PLA2 inhibitor
16251082|NCT01000727|Drug|Placebo|Placebo administered
16251083|NCT01000727|Other|Standard Therapy|Guideline mandated therapy for individual's condition
16251084|NCT01000714|Drug|Psirelax|
16251085|NCT01000688|Drug|vildagliptin + acarbose|4 week treatment
16251086|NCT01000688|Drug|acarbose + vildagliptin|4 week treatment
16251087|NCT01000662|Radiation|Daily Radiation Therapy|15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
16251088|NCT01000662|Radiation|Weekly Radiation Therapy|15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
16251089|NCT01000649|Drug|FE 202158 1.25|FE 202158 at dose 1.25 ng/kg/min infused.
16251090|NCT01000649|Drug|FE 202158 2.5|FE 202158 at dose 2.5 ng/kg/min infused.
16251091|NCT01000649|Drug|FE 202158 3.75|FE 202158 at dose 3.75 ng/kg/min infused.
16251092|NCT01000649|Other|Placebo|Isotonic saline infused.
16251093|NCT01000636|Procedure|Metvix PDT|"Methyl aminolevulinate cream will be applied for 3 hours on the whole target field.
~The target field will then be exposed to red light using Aktilite 128 lamp."
16251094|NCT01000623|Drug|venlafaxine|Given orally
16251095|NCT01000623|Drug|placebo|Given orally
16251096|NCT01000623|Procedure|hypnotherapy|Practice hypnosis
16251097|NCT01000623|Procedure|mind-body intervention procedure|Practice focused attention
16251098|NCT01000610|Drug|rituximab [MabThera/Rituxan]|1000 mg iv infusion on days 1 and 15
16251099|NCT01000610|Drug|methotrexate|10-25 mg weekly (oral or parenteral)
16251100|NCT01000610|Drug|methylprednisolone|100 mg iv prior to each rituximab infusion
16251101|NCT01000597|Drug|fluticasone furoate|"Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).
~A single intravenous dose of 250mcg FF given over 20 minutes (Day 1)."
16251102|NCT01000584|Biological|Arepanrix, Vaxigrip 2009/2010|Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
16251103|NCT01000584|Biological|Arepanrix, Vaxigrip 2009/2010|Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
16251104|NCT01000558|Other|biologic sample preservation procedure|
16251105|NCT01000545|Drug|Sulodexide|SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
16251106|NCT01000545|Drug|placebo capsules|8 soft-gel capsules per day to be taken orally for 12 months
16251107|NCT01000532|Device|SIELLO JT/T|Implantation of SIELLO and BPPU pacemaker leads
16251108|NCT01000532|Device|Pacemaker therapy|Pacemaker therapy
16251109|NCT01000532|Device|BPPU JT/T|Implantation of SIELLO and BPPU pacemaker leads
16251110|NCT01000519|Other|Aerobic Training|18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate
16251111|NCT01000519|Other|Progressive resistance training|18 sessions completed in 2 months. each session consists of 50 minutes of resistance training which is made up of 3 sets of 10 repetitions of nine resistive exercises using machines and free weights at 65-70% of 1-repetitive maximum.
16251112|NCT01000506|Biological|Mepolizumab 750|Mepolizumab 750mg every four weeks by i.v.
16251113|NCT01000506|Biological|Mepolizumab 250|Mepolizumab 250mg every four weeks by i.v.
16251114|NCT01000506|Biological|Mepolizumab 75|Mepolizumab 75mg every four weeks by i.v.
16251115|NCT01000506|Drug|Placebo saline|Placebo saline every four weeks by i.v.
16251116|NCT01000493|Drug|orvepitant|Neurokinin-1 (NK-1) antagonist
16251117|NCT01000493|Other|Placebo|Inactive placebo to match orvepitant 60 mg dosage form
16251118|NCT01000480|Drug|Pemetrexed|500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles.
16251119|NCT01000480|Drug|Cisplatin|75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles.
16251120|NCT01000480|Radiation|Thoracic Radiotherapy|Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.
16251121|NCT01000467|Drug|probucol|group 3: 250 mg 1 tablet in the morning and evening
16251122|NCT01000467|Drug|probucol|group 1: 250 mg
16254201|NCT00978549|Procedure|pain therapy|
16251123|NCT01000467|Drug|probucol|group 2: 250 mg 2 tablets at once in the morning
16251124|NCT01000441|Drug|infliximab, etanercept, adalimumab|
16251125|NCT01000441|Drug|abatacept, rituximab or tocilizumab|
16251126|NCT01000415|Other|Neoadjuvant chemotherapy followed by surgery|Cisplatin 50 mg/m2 (in the vein)on day 1 of each 23 day cycle plus gemcitabine 1000 mg/m2 (in the vein) on day 1 and day 8, for 3 cycles: until progression or unacceptable toxicity develops.
16251127|NCT01000402|Drug|Psychopharmacotherapy|Lithium (according to response, serum levels, and tolerance) 150-1500mg Valproate (according to response, serum levels, and tolerance) 125-2000mg Risperidone (according to response, and tolerance)0.5-6mg Olanzapine(according to response, and tolerance)2.5-20mg Ziprasidone(according to response, and tolerance)40-160mg Topiramate (according to response, and tolerance)25-300mg Quetiapine (according to response, and tolerance)25-500mg Aripiprazole (according to response, and tolerance)5-20mg Lamotrigine (according to response, and tolerance)25-200mg Fluoxetine (according to response, and tolerance) 1-40mg Sertraline (according to response, and tolerance)25-200mg Methylphenidate (according to weight, response, and tolerance)0.3 -0.7mg/kg/day
16251128|NCT01000389|Device|Grindcare® (Biofeedback)|Active treatment with functional electrical stimulation
16251129|NCT01000376|Drug|Eribulin alone|Group 1 Cycle 1 (28 days): Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
16251130|NCT01000376|Drug|Eribulin plus Ketoconazole|Group 2 Cycle 1 (28 days): Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
16251131|NCT01000350|Drug|Saline|IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
16251132|NCT01000350|Other|Placebo|Placebo x1 lactose tablet
16251133|NCT01000337|Drug|Sevoflurane|Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
16251134|NCT01000337|Drug|Propofol|Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
16251135|NCT01000324|Procedure|Blood sampling|Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).
16251136|NCT01000324|Biological|Engerix-B|Engerix-B will be administered to subjects who are not seroprotected against hepatitis B
16251137|NCT01000324|Biological|Havrix|Havrix will be administered to subjects who are seronegative for anti-HAV antibodies
16251138|NCT01000311|Biological|MenACWY-CRM|One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
16251139|NCT01000311|Biological|DTaP-IPV/Hib|IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
16251140|NCT01000311|Biological|HBV|IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
16251141|NCT01000311|Biological|PCV|IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
16251142|NCT01000311|Biological|MMR|Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
16251143|NCT01000298|Drug|Placebo|liquid placebo medication given twice per day for 7 days
16251144|NCT01000298|Drug|Amoxicillin|liquid amoxicillin given twice per day for 7 days
16251145|NCT01000298|Drug|Cefdinir|liquid cefdinir given twice per day for 7 days
16251146|NCT01000285|Drug|Bortezomib|
16251147|NCT01000285|Drug|Etoposide|
16251148|NCT01000285|Drug|Vincristine|
16251149|NCT01000285|Drug|Doxorubicin|
16251150|NCT01000285|Drug|Prednisone|
16251151|NCT01000285|Drug|Cyclophosphamide|
16251152|NCT01000285|Drug|Raltegravir|
16251153|NCT01000259|Other|Laboratory Biomarker Analysis|Samples are analyzed in laboratory studies
16251154|NCT01000246|Biological|influenza virus vaccine (influvac or vaxigrip)|one i.m. dose of 0.5 mL
16251155|NCT01000233|Dietary Supplement|Phytine (phytate)|300 mg tid * 24 months
16251156|NCT01000233|Dietary Supplement|Placebo|Phytine (Phytate)
16251157|NCT01000220|Drug|Omeprazole|
16251158|NCT01000220|Drug|Placebo|
16251159|NCT01000207|Biological|Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine|High dose group and low dose group of adjuvanted vaccines
16251160|NCT01000194|Dietary Supplement|High fat meal|A high fat milkshake containing 55g of fat
16251161|NCT01000181|Other|PET-CT with CuATSM|PET-CT with CuATSM
16251162|NCT01000168|Other|Treadmill therapy and conventional walking therapy.|"The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.
~The conventional group received traditional walking therapy for the same time period."
16251163|NCT01000155|Drug|vorinostat|
16251164|NCT01000142|Procedure|Osteopathic Manipulative Treatment|Focused osteopathic musculoskeletal exam; paraspinal muscle inhibition and/or soft tissue kneading or stretching; rib raising and or rib mobilization; abdominal diaphragm release technique; abdominal mesenteric/colon release; thoracic inlet release technique; hip flexion/extension range of motion; shoulder range of motion with pectoral traction; cervical paraspinal muscle inhibition and/or soft tissue kneading or stretching; suboccipital release technique; specific OMT of significant somatic dysfunction (variable).
16251165|NCT01000142|Procedure|Light Touch|Focused osteopathic musculoskeletal exam; contact ribs to simulate rib raising and paraspinal muscle inhibition; contact lower rib margin to simulate abdominal diaphragm release; palpate the four quadrants of the abdomen to simulate abdominal mesenteric/colon release; contact shoulders to simulate thoracic inlet release; contact suboccipital region to simulate thoracic inlet release.
16251166|NCT01000129|Other|Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)|Planning CT scan performed by qualified planning radiographers
16251167|NCT01000129|Other|Cone beam CT acquisition|Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.
16251168|NCT01000116|Procedure|Fibrin glue|Tissucol 2 ml
16251169|NCT01000116|Procedure|Tacks|Protacks
16251170|NCT01000103|Device|Real rTMS|Transcranial Magnetic Stimulation, in a low frequency (1 Hz) continuous train of 20 minutes (1200 pulses)
16251171|NCT01000103|Device|Sham rTMS|"two TMS coils will be used: a passive one which is placed flat on top of the actively targeted region which remains unplugged and generates a continuous scalp tactile sensation, and an active one located at a prudential distance from the scalp, which will deliver active pulses and its accompanying sensations"
16251172|NCT01000064|Drug|Vyvanse|30 mg - 70 mg capsules taken every morning for 6 weeks.
16251173|NCT01000064|Procedure|fMRI|Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
16251174|NCT01000064|Drug|Placebo|Placebo capsules taken every morning for 6 weeks.
16251175|NCT01000051|Drug|Eltrombopag|Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.
16251176|NCT01000051|Drug|Placebo|Once a day, orally for 8 weeks.
16251177|NCT01000038|Other|Wii-Fit intervention|Half hour daily, 5 days a week for 8 weeks
16251178|NCT01000038|Other|Walking|Half hour daily, five days a week for 8 weeks
16251179|NCT01000025|Drug|PF-00299804|PF-804 45 mg PO, daily
16251180|NCT01000025|Drug|Placebo|Placebo 45 mg PO, daily
16251181|NCT01000012|Device|Becker 50 Expander/Breast implant|"The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
~The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc."
16251182|NCT01000012|Device|Becker 25 Expander/Breast implant|"The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
~The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc."
16251183|NCT00999999|Procedure|Craniotomy supra- or infratentorial, dural closure|After dural closure with a water-tight suture, randomization is performed. Depending on the randomization outcome, the study drug Tachosil is applied on the dural suture or omitted.
16251184|NCT00999986|Drug|cyclophosphamide|50 mg oral per day for 7 days
16251185|NCT00999973|Drug|Mitomycin C 0.02%|
16251186|NCT00999973|Drug|Placebo|
16251187|NCT00999960|Procedure|Laparoscopic Radical Prostatectomy (without a simulator)|without simulator
16251188|NCT00999960|Procedure|Laparoscopic Radical Prostatectomy (with a simulator)|Learning with a simulator
16251189|NCT00999921|Drug|Tamoxifen|Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
16251190|NCT00999921|Drug|Evening Primrose Oil|Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
16251191|NCT00999908|Drug|Indacaterol 150 μg|Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16251192|NCT00999908|Drug|Tiotropium 18 μg|Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16251193|NCT00999908|Drug|Placebo|Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16251194|NCT00999882|Drug|AZD8055|Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal.
16251195|NCT00999869|Drug|Botulinum toxin type A|Using concentration at 2 units per 0.1 of dilution with normal saline Injection in the first visit and follow up at 1 week, 1,2,3 and 4 months after injection
16251196|NCT00999869|Drug|Triamcinolone acetonide|Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution
16251197|NCT00999856|Device|GOMIS and Photometer|Insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
16251198|NCT00999856|Device|GOMIS and Photometer|An improved insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
16251199|NCT00999856|Device|GOMIS and Photometer|Insert is placed under the conjunctiva. During measurement sessions photometer version 2 will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
16251200|NCT00999856|Device|GOMIS and Photometer|After comparing Photometer Version 1 and Version 2 the better one of them will be used for measurements in Cohort 4. A new insert will be implanted under the conjunctiva.
16251201|NCT00999856|Device|GOMIS and Photometer|The insert version with the best results will be implanted. The photometer that was used in Cohort 4 will be taken again for fluorescence measurements.
16251202|NCT00999843|Drug|Sorafenib|Sorafenib is administered only to the patients with non-progression disease (CR, PR and SD) 4 weeks after the completion of radiotherapy. The dose is 400 mg, p.o., twice a day. Sorafenib is continuously given for 12 months unless intolerable toxicities and/or tumor progression.
16251203|NCT00999830|Drug|IPH2101|One infusion of IPH2101 every 4 weeks
16251204|NCT00999817|Drug|reference [dextromethorphan]|single 30 mg oral dose
16251205|NCT00999817|Drug|test [PF-00299804 + dextromethorphan]|single 45 mg oral dose of PF-00299804 and a single 30 mg oral dose of dextromethorphan
16251206|NCT00999804|Drug|Lapatinib|1000 mg of Lapatinib by mouth daily
16251207|NCT00999804|Drug|Letrozole|Letrozole, 2.5 mg by mouth daily (for hormone receptor positive participants only)
16251208|NCT00999804|Drug|Trastuzumab|6 mg/kg intravenously, every 3 weeks
16251209|NCT00999791|Drug|Bevacizumab|
16251210|NCT00999791|Drug|Diclofenac|
16251211|NCT00999778|Behavioral|Caregiver-Mediated Intervention|1 (two- 1/2 jour sessions weekly) hour of intervention per week for 10 weeks in which parents and their child meet with the interventionist together using the caregiver as a means to facilitate change in their child's development
16251212|NCT00999778|Behavioral|Caregiver-Education Intervention|The caregiver meets 1 time (1 hour each session) a week for 10 weeks with an interventionist - caregiver will receive information on child development and have the opportunity to ask questions and discuss the information vis-a-vis their own child
16251213|NCT00999765|Behavioral|Mindfulness-Based Cognitive Therapy|eight-week (two hours a week) group therapy (8-12 patients per group)
16251214|NCT00999752|Drug|Nebivolol|5mg/day with increase to 10 mg/day to reach blood pressure <140/90
16251215|NCT00999752|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg/day
16251216|NCT00999739|Biological|Prevenar and Pneumo23|Two vaccines: participants will receive via intramuscular in deltoid one dose of conjugated heptavalent vaccine at day 0 (Prevenar, Wyeth-lederle)and one dose of 23valent polysaccharide vaccine (Pneumo23, AventisPasteur)at week4 One vaccine:participants will receive only one dose of 23valent polysaccharide vaccine at day 0.
16251217|NCT00999713|Drug|Calfactant|Endotracheal calfactant, up to 3 doses if subject qualifies
16251218|NCT00999713|Other|Air placebo|Endotracheal air administration
16251219|NCT00999700|Drug|docetaxel - cisplatin - 5-fluorouracil|docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
16251220|NCT00999700|Radiation|radiotherapy|"Conformal radiotherapy or IMRT should be employed.
~Standard radiotherapy:
~Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated."
16251221|NCT00999700|Drug|cetuximab|400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment
16251222|NCT00999700|Drug|cisplatin|Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
16251223|NCT00999700|Radiation|radiotherapy|"Conformal radiotherapy or IMRT should be employed.
~Standard radiotherapy:
~Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated."
16251224|NCT00999687|Drug|Indigo Naturalis Extract in Oil|Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks
16251225|NCT00999687|Other|Olive Oil|Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
16251226|NCT00999674|Other|An exercise program|The study subjects were recruited among those who responded to advertisements in outpatient clinics
16251227|NCT00999648|Other|Myofascial trigger point pressure release (deactivation)|The deactivation of MTP will be performed always by the same physiotherapist researcher using the same technique. Afterwards, a myofascial maneuver is performed in each treated muscle. All patients of the experimental group will be advised to perform complimentary procedures at home during the 10-week period treatment in order to maintain the status of the muscle up to the next session and to avoid losing the obtained result:(1) Stretching of the treated muscles, once a day for 25 seconds each, (2)Superficial heat in each treated muscle, once a day for 20 minutes, (3) Watch the correct postures during daily activities and sleeping.
16251228|NCT00999648|Other|Placebo myofascial trigger point pressure release|The physiotherapist researcher will press in an adjacent nontender muscle fibers of the same muscle that have MTP about 3cm to the right or to the left of each diagnosed MTP, using just a slight pressure on it, not enough for deactivation.
16251229|NCT00999635|Device|Insole|Comparison of custom made and prefabricated insoles designed for the neuropathic diabetic foot, issued for day time wear and followed for a 6 month period
16251230|NCT00999622|Other|laboratory biomarker analysis|
16251231|NCT00999622|Other|questionnaire administration|
16251232|NCT00999609|Biological|AAV2-hRPE65v2,voretigene neparvovec-rzyl|Subretinal administration of gene therapy vector AAV2-hRPE65v2 (1.5E11 vector genomes per eye) to both eyes via surgical procedures on separate days.
16251233|NCT00999583|Drug|EPOETINE ALPHA|5 injections of 40000 UI of EPO
16251234|NCT00999583|Other|Control arm|Usual take care of cardiac arrest
16251235|NCT00999570|Other|Specialty training for knee surgeons|
16251236|NCT00999557|Drug|bimatoprost ophthalmic solution|Applied topically
16251237|NCT00999557|Drug|placebo|Applied topically
16251238|NCT00999544|Drug|Aprepitant 0mg|Aprepitant 0mg, p.o. pretreatment
16251239|NCT00999544|Drug|Aprepitant 40mg|Aprepitant 40mg, p.o. pretreatment
16251240|NCT00999544|Drug|Aprepitant 200mg|Aprepitant 200mg, p.o. pretreatment
16251241|NCT00999544|Drug|Oxycodone 0mg, p.o.|Oxycodone 0mg, p.o.
16251242|NCT00999544|Drug|Oxycodone 20mg, p.o.|Oxycodone 20mg, p.o.
16251243|NCT00999544|Drug|Oxycodone 40mg, p.o.|Oxycodone 40mg, p.o.
16251244|NCT00999544|Drug|Oxycodone 0mg, IN|Oxycodone 0mg, IN
16251245|NCT00999544|Drug|Oxycodone 15mg, IN|Oxycodone 15mg, IN
16251246|NCT00999544|Drug|Oxycodone 30mg, IN|Oxycodone 30mg, IN
16251247|NCT00999531|Drug|GS-9411|Inhaled GS-9411 dissolved in sterile saline
16251248|NCT00999531|Drug|Placebo|Inhaled Placebo, sterile saline
16251249|NCT00999518|Biological|Tanezumab|1 mg dose given subcutaneously twice at an 8-week interval.
16251250|NCT00999518|Biological|Tanezumab|2.5 mg dose given subcutaneously twice at an 8-week interval.
16251251|NCT00999518|Biological|Tanezumab|10 mg dose given subcutaneously twice at an 8-week interval.
16251252|NCT00999518|Biological|Tanezumab|20 mg dose given subcutaneously twice at an 8-week interval.
16251253|NCT00999518|Other|Placebo|Placebo dose given subcutaneously twice at an 8-week interval.
16251254|NCT00999505|Drug|Amantadine|Amantadine 200mg twice a day over 12 weeks
16251255|NCT00999505|Drug|Placebo|Placebo capsules twice a day over 12 weeks
16251256|NCT00999492|Device|Tecnis® Multifocal (TMF)|Aspheric, diffractive multifocal intraocular lenses
16251257|NCT00999479|Drug|Norethindrone acetate and ethinyl estradiol tablets, USP|"Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.
~Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each white tablet also contains the following inactive ingredients: acacia, lactose, magnesium stearate, starch, confectioner's sugar, and talc."
16251258|NCT00999479|Drug|ferrous fumarate (placebo) tablets|Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.
16251259|NCT00999466|Drug|AZD8848|Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.
16251260|NCT00999466|Drug|Placebo|Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.
16251261|NCT00999453|Other|LDL-cholesterol|This is a 2-arm, open label, multi-center, randomized trial comparing aggressive to standard treatment of LDL-cholesterol. After screening, randomization, participants will be seen every 3 months during the follow-up period. An LDL-cholesterol 100 mg/dL is the goal for the standard group and the target for the aggressive group is 70 mg/dL. A lipid lowering algorithm has been developed based on the NCEP-ATP III recommendation which is used as a general guideline, allowing alterations based on the individual participants needs.
16251262|NCT00999440|Drug|Methadone|ECG (QT, QTc, Heart rate), Urine sample (opiates, benzodiazepines, THC, cocaine, amphetamines, methadone-metabolite), Questionnaire PSQI - perceived sleep - self report , Pain indices (severity, duration, cause, etc.) , usage of other medication for pain and other significant disease/disorders, history of drug abuse, age, sex, place of birth and ethnic origin, comorbidity. Follow up after 4weeks, 6months and 1 year will be done. Patients who start with any opiate and then switch to methadone, move to methadone follow up
16251263|NCT00999427|Drug|Povidone-iodine|Povidone-iodine 10% solution. A piece of 10x10 cm gauze soaked in Povidone-iodine 10% solution wrapped around the index finger of the examiner is inserted into the rectum of the subject in arm A. This gauze will be wiped back and forth across the prostate with the finger at least five times from one lateral margin of the prostate gland to the other. The examiner will allow at least 2 minutes to elapse between antisepsis and the insertion of the first needle into the prostate in order to allow the Povidone-iodine to dry.
16251264|NCT00999414|Drug|Carfilzomib|"Carfilzomib (20mg/m2) IV push to be given at maximum rate of 10ml/minute on Days 1 and Day 2 of Cycle 1 only.
~Carfilzomib (27mg/m2) IV bolus to be given at maximum rate of 10ml/minute on Day 8, 9, 15, and 16 of Cycle 1, then through Cycle 2 and beyond if initial dosing with 20mg/m2 tolerated.
~For patients who tolerated 27mg/m2 through cycle 2 Days 1 and 2, Carfilzomib dose may be escalated to 36mg/m2 on days 8, 9, 15 and 16 of cycle 2. If tolerated, subsequent cycles will utilize 36mg/m2."
16251265|NCT00999401|Drug|sapacitabine and seliciclib|sequential or concomitant administration of sapacitabine and seliciclib
16251266|NCT00999375|Behavioral|Education|
16251267|NCT00999375|Behavioral|Problem Solving|
16251268|NCT00999375|Behavioral|Social Learning|
16251269|NCT00999375|Behavioral|Behavior Modification|
16251270|NCT00999349|Drug|Silymarin (LEGALON)|Study group: Silymarin Capsule, 140 mg, 3 times a day + desferrioxamine injection 50 mg/kg, Placebo group:Placebo capsules Similar to Silymarin +desferrioxamine injection 50 mg/kg
16251271|NCT00999349|Drug|Placebo|
16251272|NCT00999336|Drug|Betrixaban|80 mg betrixaban qd for 8 days
16251273|NCT00999323|Device|stent implantation in coronary artery|Percuatenous Coronary Intervention with implanatation of a stent
16251274|NCT00999297|Other|Dihydrocapsiate|Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
16251275|NCT00999297|Other|Dihydrocapsiate|Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
16251276|NCT00999297|Other|Dihydrocapsiate|Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
16251277|NCT00999284|Drug|ZK200775|Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
16251278|NCT00999284|Drug|ZK200775|Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
16251279|NCT00999284|Drug|Sodium Chloride|Intravenous infusion of sodium chloride over a period of 4 hours.
16251280|NCT00999271|Other|Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)|"two different dosages:
~0.8 pmol/kg/min
~1.5 pmol/kg/min for 300 minutes"
16251281|NCT00999258|Drug|sirolimus|"The subjects assigned to the sirolimus conversion group will be initiated on sirolimus 5mg po daily at which time their tacrolimus dose will be decreased by 50%. Sirolimus levels will be checked within a week and adjusted in a linear fashion to achieve a trough goal of 12-15ng/ml in subjects within 1 year post-transplant, and 8-12 ng/ml in subjects more than 1 year post-transplant. Tacrolimus will be continued in these subjects until sirolimus target trough levels are achieved. Thereafter, tacrolimus will be discontinued indefinitely.
~The subjects assigned to the tacrolimus maintenance group (control group) represent our present standard of care."
16251282|NCT00999245|Other|High Demand / Low Infusion|HDLI dosing plan will administer either morphine or hydromorphone using PCA. Dosing will be based on body weight.
16251283|NCT00999245|Other|PCA Dosing Plan|LDHI dosing plan will administer either morphine ot hydromorphone using PCA. Dosing will be based on body weight.
16251284|NCT00999232|Drug|Erythromycin|Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube
16251285|NCT00999232|Drug|Placebo|Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube
16251286|NCT00999219|Drug|FK199B|oral
16251287|NCT00999219|Drug|Zolpidem|oral
16251288|NCT00999206|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in cell cultures
16251289|NCT00999206|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in egg (influvac ®)
16251290|NCT00999206|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in cell cultures
16251291|NCT00999206|Biological|Influenza Vaccine|surface antigen, inactivated, prepared in cell cultures
16251292|NCT00999193|Procedure|locking plate, ORIF|Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
16251395|NCT00998283|Drug|HM10460A 45μg/kg|Subcutaneously administrate at 0 hour on Day 1
16251293|NCT00999193|Procedure|Hemiarthroplasty|Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
16251294|NCT00999193|Other|Conservative treatment|Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.
16251295|NCT00999180|Procedure|Botulinum toxin type A and kinesiotherapy|Stroke, Botulinum Toxin
16251296|NCT00999180|Procedure|Saline and Kinesiotherapy|Saline and Kinesiotherapy
16251297|NCT00999167|Drug|HPN-100|Part B: 6 mL BID for 16 weeks.
16251298|NCT00999167|Drug|Placebo|Part B: same as experimental arm
16251299|NCT00999141|Biological|FS VH S/D 4 s-apr|FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.
16251300|NCT00999128|Drug|GDC-0941|Oral repeating dose
16251301|NCT00999128|Drug|rabeprazole|Oral repeating dose
16251302|NCT00999115|Drug|Expanded allogenic adipose-derived adult stem cells|Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.
16251303|NCT00999102|Drug|Metoprolol|Metoprolol 50 mg, Metoprolol 100 mg,
16251304|NCT00999102|Drug|Nebivolol|Nebivolol 5 mg, Nebivolol 10 mg.
16251305|NCT00999089|Procedure|Conventional Coronary Artery Bypass|Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
16251306|NCT00999089|Procedure|Off-Pump Coronary Artery Bypass|Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
16251307|NCT00999089|Procedure|Pump-Assisted Coronary Artery Bypass|Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation
16251308|NCT00999050|Procedure|Gastric bypass for diabetic patients <35 BMI|The operation is performed under general anesthesia. It is done laparoscopically, meaning that several small openings are made in the abdomen for insertion of long, thin surgical instruments, one with an attached camera. The operation is video monitored. The top of the stomach is divided across, leaving a small pouch for food. The rest of the stomach remains but can receive no food. The gut is divided just past the stomach, and it is attached to the small stomach pouch so that food can get back into the bowel. A second connection is made so that the bile and digestive juices pass into the bowel with the food.
16251309|NCT00999037|Drug|Sevelamer Carbonate|Daily renvela (800 mg tid with meals) x 12 weeks
16251310|NCT00999037|Other|Placebo|1 inert tablet tid x 12 weeks
16251311|NCT00999011|Procedure|once daily mobility activity|in bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking.
16251312|NCT00999011|Procedure|twice daily mobility activity|as with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms
16251313|NCT00998998|Behavioral|Home stimulation|Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
16251314|NCT00998998|Behavioral|Surveillance|Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
16251315|NCT00998998|Dietary Supplement|Iron|Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.
16251316|NCT00998985|Drug|Grazoprevir|10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
16251317|NCT00998985|Drug|Placebo|Placebo tablet, orally, once a day for 7 days
16251318|NCT00998972|Drug|N-acetylcysteine|600 mg intravenous before and 2 hours after cerebral arteriography
16251319|NCT00998959|Behavioral|Mindfulness Based Stress Reduction and Psychoeducation|Participants will receive six individual weekly 50-minute sessions of mindfulness based stress reduction (MBSR) as well as problem solving therapy (PST. PST is a type of therapy that focuses on psychosocial problems and using your skills and resources to function better. MBSR uses exercises in mindfulness to reduce stress.
16251320|NCT00998959|Behavioral|Psychoeducation|Participants will receive six individual weekly 50-minute sessions of psychoeducation. Psychoeducation consists of education on depression, its symptoms, its treatment, and recovery.
16251321|NCT00998946|Drug|Pralatrexate Injection|"Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride).
~Initial dose: 30 mg/m2
~Dose reductions: to 20 mg/m2 weekly per protocol defined criteria.
~Administered on days 1, 8 and 15 of a 4-week (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met."
16251322|NCT00998946|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate."
16251323|NCT00998946|Dietary Supplement|Folic Acid|"1 mg orally
~Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate."
16251324|NCT00998933|Drug|Testosterone gel 1.62%|5 grams applied topically to upper arms/shoulder and abdomen on Day 1
16251325|NCT00998920|Drug|S-equol|oral, BID, 14 days
16251326|NCT00998920|Drug|Placebo|oral, BID, 14 days
16251327|NCT00998907|Device|PDS plus|triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)
16251328|NCT00998907|Device|PDS II|polyglactin 910 suture material for abdominal wall closure
16251329|NCT00998881|Drug|Teneligliptin 20 mg|
16251330|NCT00998881|Drug|Placebo|
16251331|NCT00998855|Behavioral|Exercise|12 wk aerobic or/ resistance exercise program
16251332|NCT00998842|Device|Recom Model 100|Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
16251333|NCT00998842|Device|GE 5000 ECG Monitor System|Wired ECG system
16251396|NCT00998283|Drug|HM10460A 135μg/kg|Subcutaneously administrate at 0 hour on Day 1
16251397|NCT00998283|Drug|HM10460A 350μg/kg|Subcutaneously administrate at 0 hour on Day 1
16251334|NCT00998829|Other|questionnaire|There is no therapeutic intervention in this study. However PASE (Psoriatic Arthritis Screening and Evaluation) and other patient questionnaires will be completed by participants.
16251335|NCT00998816|Drug|Pregabalin|pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.
16251336|NCT00998790|Device|American Medical Systems (AMS) AdVance™ Male Sling System|The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
16251337|NCT00998777|Procedure|Shoulder Strengthening|The intervention program is a 6 week shoulder and scapular stabilizer strengthening program that is performed 3 times per week. The program includes 10 exercises that are performed with Theraband rubber tubing and 2 stretches. The exercises are: shoulder flexion, Ys, Ts, Ws, IR @ 90, ER @ 90, Throwing acceleration, Throwing deceleration, dynamic hug, and low rows. The stretches include the sleeper stretch and the corner stretch.
16251338|NCT00998764|Drug|Bapineuzumab 0.5 mg/kg|I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
16251339|NCT00998751|Drug|oral masitinib|7.5 mg/kg/day
16251340|NCT00998738|Drug|Calcium Gluconate|Given IV
16251341|NCT00998738|Drug|Magnesium Sulfate|Given IV
16251342|NCT00998738|Other|Placebo|Given IV
16251343|NCT00998738|Other|Quality-of-Life Assessment|Ancillary studies
16251344|NCT00998738|Other|Questionnaire Administration|Ancillary studies
16251345|NCT00998738|Drug|Ixabepilone|Given IV
16251346|NCT00998699|Drug|Xoma 052|Sterile solution subcutaneously administered every 4 weeks for 12 weeks
16251347|NCT00998699|Drug|Placebo|Sterile solution subcutaneously administered every 4 weeks for 12 weeks
16251348|NCT00998686|Drug|dutogliptin|400 mg
16251349|NCT00998686|Drug|sitagliptin|100 mg
16251350|NCT00998673|Device|Silica Gel Fiber|Silica Gel Fiber (SGF) applications as required
16251351|NCT00998673|Device|Standard-of-Care|Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings
16251352|NCT00998660|Device|Activa RC|Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
16251353|NCT00998647|Device|modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus|usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids
16251354|NCT00998634|Drug|LITHIUM CARBONATE|Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
16251355|NCT00998621|Other|Adherence questionnaire|Adherence questionnaire
16251356|NCT00998608|Drug|risperidone|risperidone 4mg/d
16251357|NCT00998595|Other|Promotora|The Promotora will deliver education regarding postpartum follow-up and steps to take to decrease the risk for developing type 2 diabetes. The Promotora will clarify misperceptions and answer questions related to risk of developing diabetes and contraception. If the subject has barriers to accessing care with transportation or childcare, she will help the subjects to access existing resources. The Promotora will give the subject her contact information and will also contact the subject to remind her of her appointments and reschedule if she missed an appointment.
16251358|NCT00998582|Drug|Tenofovir disoproxil|Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.
16251359|NCT00998569|Behavioral|Neurocognitive Enhancement|Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.
16251360|NCT00998569|Behavioral|Wait List|Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.
16251361|NCT00998556|Drug|Bromocriptine|Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks. The study medication is taken on top of standard therapy for heart failure.
16251362|NCT00998517|Dietary Supplement|Soy/peanut fortified spread|75kcal/kg/day
16251363|NCT00998517|Dietary Supplement|Milk fortified corn/soy blend|75 kcal/kg/day
16251364|NCT00998517|Dietary Supplement|Supplementary Plumpy®|75 kcal/kg/day
16251365|NCT00998504|Dietary Supplement|resVida|resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.
16251366|NCT00998504|Dietary Supplement|placebo|resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.
16251367|NCT00998478|Other|Activity Knowledge Circuits|The activity knowledge circuits were implemented, where in addition to regular physical education (PE) activity was increased by two hours a week over an 18-week period. Participants briskly walked 3200 m twice weekly during curriculum lessons (60 min). Short tasks, in line with current curriculum, were provided by subject teachers for participants to complete at stations set every 400 or 800 m. Crucially participants continued to follow national curriculum whilst exercising. Tasks designed by teachers lasted no longer than 60 seconds at each station. With the exception of PE, each curriculum subject delivered a total of four intervention lessons. Circuits were performed outdoors on school premises, with an indoor course of equal distance used during adverse weather conditions.
16251368|NCT00998465|Other|24-hour blood pressure|Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
16251369|NCT00998465|Other|Echocardiography|Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
16251370|NCT00998465|Other|Inert gas rebreathing|Cardiac output, stroke volume and total peripheral resistance are tested at rest and during exercise (bicycle ergometer) using non-invasive equipment (inert gas rebreathing - Innocor)
16251371|NCT00998465|Radiation|Dexa-scan|Fat mass and fat free mass is determined with a whole body Dexa scan, and bone mineral density is tested with Dexa-scans of the lumbar spine and proximal femur.
16251372|NCT00998465|Radiation|Plasma volume|The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
16251373|NCT00998465|Radiation|Glomerular filtration rate (GFR)|GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
16251374|NCT00998465|Other|Blood samples|p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
16251375|NCT00998465|Other|Urine analyses|24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
16251376|NCT00998465|Dietary Supplement|Diets with low and high sodium content|Participants are subjected to 5 days of low (90 mmol/day) and high (250 mmol/day) sodium intake in a randomized order before and 1 year after laparoscopic gastric bypass surgery.
16251377|NCT00998452|Behavioral|MOVE*VETS|Receiving 4 tailored newsletters on the study health behavior topics created from the baseline survey. Also 2-4 counseling calls from peer counselors.
16251378|NCT00998439|Device|SeQuent® Please|"6 F, 7 F, or 8 F guiding catheters have to be used
~after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight))
~additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour
~Nitroglycerin (0.2 mg i.c.) prior to first contrast injection
~ISR must be predilated with uncoated balloon
~balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use
~inflation time has to be ≥ 30 sec
~select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 %
~each Paclitaxel-eluting balloon catheter is allowed for single use only
~additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness
~if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug"
16251379|NCT00998439|Device|SeQuent® II|"6 F, 7 F, or 8 F guiding catheters have to be used
~after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight))
~additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour
~Nitroglycerin (0.2 mg i.c.) prior to first contrast injection
~ISR must be predilated with uncoated balloon
~balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use
~inflation time has to be ≥ 30 sec
~select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 %
~each Paclitaxel-eluting balloon catheter is allowed for single use only
~additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness
~if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug"
16251380|NCT00998426|Procedure|glucose monitoring before and after HepaGam B administration|Glucose monitoring before and after HepaGam B administration. Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.
16251381|NCT00998426|Biological|HepaGam B (Hepatitis B Immune Globulin (HBIG))|Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring.
16251382|NCT00998413|Behavioral|Multifaceted intervention|multifaceted family-based, physical exercise, nutrition, and behavioural intervention study for 18 month, in children aged 6-16 years with asthma and overweight/obesity.
16251383|NCT00998400|Behavioral|CBT in combination with WBT and life style modification|CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others. CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
16251384|NCT00998361|Procedure|Allogeneic hemopoietic stem cell transplant|administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell
16251385|NCT00998348|Behavioral|Parenting Program|The parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors. Topics will include stress management, child management, family routines, emotion regulation, and coparenting. In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home. The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11). A complementary child program will be delivered to children while parents are attending the group sessions.
16251386|NCT00998335|Drug|Long-acting bedtime insulin detemir (Levemir)|This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
16251387|NCT00998335|Drug|Insulin detemir and pre-meal insulin aspart.|This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner.
16251388|NCT00998322|Biological|REOLYSIN|1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9 of a 21-day cycle.
16251389|NCT00998322|Drug|Gemcitabine|800 mg/m2 30-min infusion on Days 1 and 8 of a 21-day cycle.
16251390|NCT00998309|Drug|Azithromycin SR|Zithromax SR 2g, taking once for treatment.
16251391|NCT00998296|Drug|BIBW 2992|EGFR inhibitor
16251392|NCT00998296|Drug|BIBF 1120|VEGF inhibitor
16251393|NCT00998283|Drug|HM10460A 5μg/kg|Subcutaneously administrate at 0 hour on Day 1
16251394|NCT00998283|Drug|HM10460A 15μg/kg|Subcutaneously administrate at 0 hour on Day 1
16251398|NCT00998283|Drug|Placebo|Subcutaneously administrate at 0 hour on Day 1
16251399|NCT00998270|Procedure|Autologous bone marrow transplantation|"Autologous transplantation:
~Endoxan (for mobilization) Dose: 2.5 g/m2 IV Time: -11 Duration: 1 day
~G-CSF (Neupogen) Dose: 0.5 micg/kg subcutaneous Time: -6 to -3 Duration: 4 days
~Melphalan Dose: 100 mg/m2 IV Time: -2 and -1 Duration: 2 days"
16251400|NCT00998270|Procedure|Allogeneic bone marrow transplantation|"Allogeneic
~Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days
~Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days"
16251401|NCT00998257|Drug|EE20/DRSP (YAZ, BAY86-5300)|Patients under daily life treatment with YAZ according to local drug information.
16251402|NCT00998244|Other|Diet - very low carb or low fat|Diet comparison in Gastroesophageal Reflux Disease
16251403|NCT00998231|Biological|blood sample|Blood collections and peripheral blood mononuclear cells extraction will be operated after each evaluation and followed by RNA extraction, reverse transcription and gene expression quantification by real-time PCR.
16251404|NCT00998218|Drug|Ranolazine|Ranolazine at 1000 mg BID (or 500 mg BID if the 1000 mg dose was not tolerated) or a comparable placebo for the next 4 weeks
16251405|NCT00998218|Drug|Placebo|Ranolazine at 1000 mg BID (or 500 mg BID if the 1000 mg dose was not tolerated) or a comparable placebo for the next 4 weeks
16251406|NCT00998205|Drug|Dobutamine stress echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micro-grams/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micro-grams/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate.
16251407|NCT00998205|Drug|Atropine bolus|If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
16251408|NCT00998192|Biological|REOLYSIN|3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
16251409|NCT00998192|Drug|Paclitaxel|200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
16251410|NCT00998192|Drug|Carboplatin|6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
16251411|NCT00998179|Device|Acu-TENS|Application of Acu-TENS (with electrical output from the machine)
16251412|NCT00998179|Device|Placebo-TENS|Application of Acu-TENS (without electrical output from the machine)
16251413|NCT00998166|Drug|Pemetrexed, Cisplatin, Bevacizumab|"Pre-hydration for 1-1/2 hours at 250 ml/hour
~Pemetrexed 500 mg/m2 IV over 10 minutes
~Return to hydration for 30 minutes at 250 ml/hour
~Cisplatin 75mg/m2 IV over 60-120 minutes
~Bevacizumab 15mg/kg IV over 90 minutes"
16251414|NCT00998153|Behavioral|Risk Reduction through Family Therapy|Component based intervention based on existing empirically supported treatments
16251415|NCT00998114|Behavioral|Exercise|Aerobic exercise for 30-45 minutes five times a week for six months
16251416|NCT00998101|Drug|cetuximab|400 mg/m2 Cycle 1 day 1 only over 120 minutes 250 mg/m2 Cycle 1 days 8,15 AND on all other cycles days 1,8,15 over 60 minutes
16251417|NCT00998101|Drug|carboplatin|AUC=6 Day 1 of treatment over 30 minutes every 21 days
16251418|NCT00998101|Drug|ixabepilone|30 mg/m2 , Day 1 over 3 hours every 21 days
16251419|NCT00998088|Other|erythropoietin and cell saver|weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion
16251420|NCT00998088|Drug|erythropoietin|weekly 40.000 IU s.c. for 4 weeks pre-operatively
16251421|NCT00998088|Device|OrthoPAT|for intra- and post-operative re-infusion of autologous wound blood
16251422|NCT00998088|Device|Post-operative drain device|For post-operative re-infusion of unwashed wound blood
16251423|NCT00998088|Other|Erythropoietin and OrthoPAT|weekly 40.000 IU s.c. for 4 weeks pre-operatively
16251424|NCT00998088|Other|Erythropoietin and drain device|weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period
16251425|NCT00998088|Device|OrthoPAT|For intra- and post-operative reinfusion of autologous blood
16251426|NCT00998075|Drug|Esomeprazole/ASA Fixed Combination|Capsule, oral, single dose
16251427|NCT00998075|Drug|Esomeprazole - Nexium|Clinical Trial Capsule or MUPS Tablet, oral, single dose
16251428|NCT00998075|Drug|ASA|Tablet, oral, single dose
16251429|NCT00998049|Drug|plerixafor|Plerixafor 160mg/kg/dose by IV on days 5-8
16251430|NCT00998049|Drug|filgrastim|Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
16251431|NCT00998036|Drug|Temsirolimus|"Temsirolimus will be administered intravenously weekly on days one and eight of a three week cycle. Temsirolimus will not be given on week three (usually dosed weekly) for increased tolerability given its possible plasma accumulation during week three. Temsirolimus will be given second over a 30 minute infusion during posthydration.
~Dose escalation will follow the standard 3 by 3 design with three set dosing levels.
~Dose Level 1: Temsirolimus 15mg
~Dose Level 2: Temsirolimus 15mg
~Dose Level 3: Temsirolimus 25mg"
16251432|NCT00998036|Drug|Cisplatin|Cisplatin at 30mg/m2 will be administered intravenously weekly on days one and eight of a three week cycle. Cisplatin will be given first over a 30 minute infusion with prehydration.
16251433|NCT00998036|Drug|Erlotinib|"Erlotinib will be taken by mouth daily starting at 100mg. On days of cisplatin and temsirolimus infusions, erlotinib should be taken at least two hours after the beginning of the temsirolimus infusion.
~Dose escalation will follow the standard 3 by 3 design with three set dosing levels.
~Dose Level 1: Erlotinib 100mg
~Dose Level 2: Erlotinib 150mg
~Dose Level 3: Erlotinib 150mg"
16251434|NCT00998023|Device|Mynx Vascular Closure Device|Comparison of two different vascular closure devices.
16251435|NCT00998023|Device|AngioSeal Vascular Closure Device|Comparison of two different vascular closure devices.
16251436|NCT00998010|Drug|bortezomib + temozolomide+ radiation therapy|Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy.
16251437|NCT00997997|Drug|Moxifloxacin (Avelox, BAY12-8039)|400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information
16251438|NCT00997984|Drug|extended-release guanfacine hydrochloride (SPD503)|dosed in AM
16251439|NCT00997984|Drug|placebo|dosed in the AM or PM
16251440|NCT00997984|Drug|extended-release guanfacine hydrochloride|Dosed in the PM
16251441|NCT00997971|Other|Modilac Rose 1|Infant formula used for non-breastfed children
16251442|NCT00997958|Drug|Mycophenolate mofetil|"Dose escalation increasing successively from 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5.0 grams p.o. bid.
~Each patient will be treated for eight weeks (56 days)."
16251443|NCT00997945|Drug|ZD4054 (Zibotentan)|10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
16251444|NCT00997932|Drug|Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration|Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
16251445|NCT00997919|Drug|MABT5102A|single SC dose
16251446|NCT00997919|Drug|MABT5102A|single IV dose
16251447|NCT00997906|Drug|carboplatin,|Given IV
16251448|NCT00997906|Drug|cisplatin|Given IV
16251449|NCT00997906|Drug|gemcitabine hydrochloride|Given IV
16251450|NCT00997906|Drug|paclitaxel|Given IV
16251451|NCT00997906|Radiation|intensity-modulated radiation therapy|Given once daily 5 days a week for 6½ weeks.
16251452|NCT00997893|Dietary Supplement|Soy Phytoestrogen|Novasoy® pill (55 mg)
16251453|NCT00997893|Drug|Estradiol|Estradiol pill (1 mg)
16251454|NCT00997893|Drug|Medroxyprogesterone Acetate (MPA)|medroxyprogesterone acetate (MPA) (10mg)
16251455|NCT00997893|Drug|Soy Placebo|oral placebo pill (0mg Soy Phytoestrogen)
16251456|NCT00997893|Drug|MPA Placebo|oral placebo pill (0mg MPA)
16251457|NCT00997880|Drug|Rosuvastatin calcium 40mg|Rosuvastatin calcium 40mg
16251458|NCT00997880|Drug|Rosuvastatin calcium10mg|Rosuvastatin 10mg
16251459|NCT00997867|Procedure|Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip|Patients undergoing orthopedic surgery who are getting a perineural catheter will be randomized to one of two groups: catheter tip placed 0-1cm past needle tip or catheter tip placed 5-6cm past needle tip. Patients will be called by research staff the day following surgery to assess their post-surgical pain using a numeric rating scale.
16251460|NCT00997854|Other|Length of time for feed administration|Group 1 will consist of babies fed by bolus method, administered over no more than 30 minutes. Group 2 will be fed by slow infusion by pump over 2 hours.
16251461|NCT00997841|Procedure|Point-of-Care versus conventional coagulation management|Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency
16251462|NCT00997828|Device|everolimus-eluting stent|Xience V stent
16251463|NCT00997828|Procedure|coronary artery bypass graft surgery|coronary artery bypass graft surgery
16251464|NCT00997815|Drug|Botulinum toxin A|Concentration at 2 units per 0.1 of normal saline dilution
16251465|NCT00997815|Drug|Normal saline injection|Using normal saline 2.5 ml injected in control side
16251466|NCT00997802|Device|CT colonography and optical colonoscopy|All patients will undergo CT colonography and optical colonoscopy.
16251467|NCT00997789|Drug|Rebamide|Rebamipide 100 mg Tablet, three times a day
16251468|NCT00997776|Other|progressive resistance exercise|lower extremity strengthening: 3 sets of 8 repetitions at the 8 repetition maximum (8RM)for the hip and knee extensors, hip abductors, plantarflexors twice weekly for 10 weeks.
16251469|NCT00997776|Other|TENS|Transcutaneous electrical nerve stimulation (TENS) to elicit sensory information (comfortable tingling) for 7 minutes to bilateral muscle groups including the gluteal muscles, quadriceps, and gastroc-soleus muscles. TENS administered twice weekly for 10 weeks.
16251470|NCT00997763|Device|XIENCE V|everolimus-eluting stent
16251471|NCT00997763|Device|CYPHER|sirolimus-eluting stent
16251472|NCT00997750|Drug|Lornoxicam|lornoxicam 8mg/day and 12mg/day for 15 days
16251473|NCT00997737|Device|DB, VI and FI|Two modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne.
16251474|NCT00997724|Procedure|a-VATS|In brief, general anesthesia with selective lung ventilation was performed with the use of a double-lumen endotracheal tube. When postoperative mechanical ventilation was necessary, a standard endotracheal tube was substituted for the double-lumen tube. Patients were placed in the lateral decubitus position. Two thoracoports were placed in the sixth or seventh intercostal space (ICS) on the anterior axillary line and in the seventh or eighth ICS on the posterior axillary line; an anterolateral minithoracotomy (7 cm) was made in the fourth ICS for an upper lobectomy or in the fifth ICS for a middle or lower lobectomy.
16251475|NCT00997711|Device|Cypher|Sirolimus-eluting stents
16251476|NCT00997685|Drug|Capecitabine plus oxaliplatin|"Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w,
~4 pre-operative cycles, 4 post-operative cycles"
16251477|NCT00997672|Drug|Lithium Carbonate|Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
16251478|NCT00997672|Drug|Placebo|
16251479|NCT00997659|Dietary Supplement|chromium picolinate|1000 mg per day
16251480|NCT00997620|Drug|Fluticasone furoate Nasal Spray 110 mcg|Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.
16251481|NCT00997620|Drug|Placebo|Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
16251482|NCT00997607|Biological|Ebola vaccine|4 mg of Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
16251483|NCT00997607|Biological|Marburg vaccine|4 mg of Marburg DNA plasmid vaccine, VRC-MARDNA025-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
16251484|NCT00997607|Other|Placebo injection|4 mg of saline injection delivered at Weeks 0, 4, and 8
16251528|NCT00997204|Drug|Icatibant|Single subcutaneous injection of icatibant, 30 mg
16254202|NCT00978549|Procedure|quality-of-life assessment|
16251485|NCT00997594|Procedure|Radiofrequency ablation|Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.
16251486|NCT00997581|Drug|apremilast|apremilast 20 mg taken twice daily by mouth
16251487|NCT00997581|Drug|indomethacin SR|indomethacin SR 75 mg taken twice daily by mouth
16251488|NCT00997568|Device|PET-511BTM|Transesophageal Transducer
16251489|NCT00997555|Procedure|bronchoscopy|Scheduled bronchoscopy.
16251490|NCT00997542|Drug|Allopurinol|
16251491|NCT00997542|Drug|Placebo|
16251492|NCT00997529|Drug|nonmyeloablative stem cell transplant|Conditioning includes cytoxan 60mg/kg/d on Days 6 & 5, total dose 120mg/kg, Fludarabine 25mg/m2/d on days -5 to -1, total dose 125mg/m2. Patients with decreased cardiac or liver function pre-transplant will have their dose of cytoxan reduced by 25% - 45 mg/kg/d for 2 days or total dose of 90mg/kg. Patients will receive G-CSF (5ug/kg) to foster engraftment. PBSC progenitors will be mobilized from donor with G-CSF 5ug/kg 2x daily starting 4 days prior to stem cell collection until a target of 5-10 x106 CD34+ cells/kg is reached. Peripheral blood progenitors will be isolated from leukaphereses obtained on Days 5 & 6 with additional collections dependent on cell yields. Peripheral blood from donors will be given to patients 1 day after cytoreduction & immunosuppression. Immunosuppression will be tapered Day +60 if no signs of GVHD. Patients with residual non-regressing disease or mixed chimerism after day 100, who are off immunosuppression & do not have signs of GVHD, will receive a DLI
16251493|NCT00997516|Procedure|SILS appendectomy|Use of SILSPort to perform laparoscopic appendectomy
16251494|NCT00997516|Procedure|conventional laparoscopic appendectomy|conventional laparoscopic removal of the appendix
16251495|NCT00997503|Device|TAXUS Liberté Paclitaxel-Eluting Coronary Stent|The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.
16251496|NCT00997503|Drug|prasugrel|10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure
16251497|NCT00997503|Drug|placebo|Oral placebo to match both 10mg and 5mg prasugrel tablets.
16251498|NCT00997503|Drug|aspirin|"Oral, as prescribed by physician through end of study.
~."
16251499|NCT00997490|Drug|Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)|3 x 2 tablets/day over 6 weeks
16251500|NCT00997490|Drug|film-coated sugar-pill|3 x 2 tablets / day over 6 weeks
16251501|NCT00997477|Drug|Foradil Combi (Formoterol-budesonide)|
16251502|NCT00997451|Behavioral|Cognitive-behavioral self-management|Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
16251503|NCT00997451|Behavioral|Symptom monitoring|Daily symptom via web diary
16251504|NCT00997438|Dietary Supplement|Lipoic Acid|300 mg Lipoic acid tablets from Vital Nutrients
16251505|NCT00997425|Device|Door cover/Floor cover|"Door cover - a neutral-colored canvas cloth covering the entire interior surface of the monitored door and attached to the door using a combination of Velcro and double-faced tape.
~Floor cover - a 4'X 4' black, rubberized mat with an overlay of very thin strips of 2 white duct tape placed at 2 intervals, nonskid and fastened securely to the floor immediately in front of the interior face of a main exit door."
16251506|NCT00997412|Drug|Mycophenolic acid|180 mg/tablet, 4 tablets twice daily
16251507|NCT00997412|Drug|AZA|1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily
16251508|NCT00997399|Drug|panobinostat (LBH589)|
16251509|NCT00997386|Drug|busulfan, and melphalan, and alemtuzumab|"intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).
~intravenous melphalan 100 mg/m2 on day -3.
~intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1."
16251510|NCT00997373|Drug|Letrozole|2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
16251511|NCT00997360|Drug|PKI-179|
16251512|NCT00997347|Drug|Mifepristone and misoprostol|"200 mg oral mifepristone
~800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone"
16251513|NCT00997334|Drug|Erlotinib|
16251514|NCT00997321|Drug|propofol|propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
16251515|NCT00997321|Drug|Ketamine|ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation
16251516|NCT00997308|Drug|AZD1446|Solution, oral, for 4 weeks
16251517|NCT00997308|Drug|Placebo|
16251518|NCT00997282|Drug|OPC-262 2.5 mg|orally administered once daily for 24 weeks
16251519|NCT00997282|Drug|OPC-262 5 mg|orally administered once daily for 24 weeks
16251520|NCT00997282|Drug|Placebo|orally administered once daily for 24 weeks
16251521|NCT00997269|Dietary Supplement|Co-enzyme Q-10|Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
16251522|NCT00997269|Dietary Supplement|Placebo|Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
16251523|NCT00997256|Drug|Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))|3 x 2 tablets / day over 3 days
16251524|NCT00997256|Drug|film-coated sugar-pill|3 x 2 tablets / day over 3 days
16251525|NCT00997243|Biological|lintuzumab|Cycle 1 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22. Subsequent Cycles (cycles to be repeated every 28 days) 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy. Doses should be given at least 12 days apart. By convention, dosing on days 7 and 22 of each cycle will be encouraged, but due to expected issues of patient convenience (time, travel, etc.), the study requirements are every other week, twice during each cycle, with one dose during AZA treatment.
16251526|NCT00997243|Drug|5-azacytidine|75mg/m2 IV/SC daily on days 1-7.
16251527|NCT00997217|Procedure|remote ischemic preconditioning|remote ischemic preconditioning (4 x 5 min upper limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis or cardiopulmonary bypass)
16251564|NCT00996892|Drug|Pictilisib|Repeated oral dosing.
16251529|NCT00997191|Procedure|Laser photocoagulation|Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
16251530|NCT00997191|Drug|Intravitreal triamcinolone|Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT>275um
16251531|NCT00997191|Drug|Intravitreal bevacizumab|Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT>275um
16251532|NCT00997178|Procedure|Non-surgical periodontal therapy|Non-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse
16251533|NCT00997178|Other|Delayed non-surgical periodontal therapy|Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit
16251534|NCT00997152|Drug|JTT-654|Tablets
16251535|NCT00997152|Drug|JTT-654 Placebo|Tablets
16251536|NCT00997139|Drug|Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)|2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.
16251537|NCT00997126|Drug|Propofol|Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
16251538|NCT00997126|Drug|Alfentanil|Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
16251539|NCT00997113|Drug|propofol|1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
16251540|NCT00997113|Drug|alfentanil|alfentanil 10 ug/kg immediately prior to propofol dose
16251541|NCT00997100|Drug|paquinimod (ABR-215757)|The initial daily dose of ABR-215757 is changed to 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment
16251542|NCT00997087|Drug|Flumazenil|Sublingual daily
16251543|NCT00997074|Drug|ibuprofen|The most common side effect observed during medical abortion using mifepristone together with misoprostol is abdominal pain. The use of ibuprofen was not shown to interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion.
16251544|NCT00997061|Drug|HYCAMTIN|Observing patients on HYCAMTIN and other drugs for SCLC.
16251545|NCT00997048|Procedure|Laying open|Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg
16251546|NCT00997048|Procedure|Sinus excision|Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg
16251547|NCT00997035|Drug|Voriconazole|"1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
16251548|NCT00997035|Drug|Placebo|"1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
16251549|NCT00997022|Drug|Sorafenib|"Dose escalation:
~Dose level 1: 200mg of sorafenib daily
~Dose level 2: 200mg of sorafenib BID (twice daily)
~Dose level 3: 200mg QAM (taken every morning) and 400mg QPM (taken every evening)
~Dose level 4: 400mg BID (twice daily)"
16251550|NCT00997009|Drug|paclitaxel|175 mg/m2 IV day 1, every 21 days
16251551|NCT00997009|Drug|carboplatin|AUC 5 IV day 1 every 21 days
16251552|NCT00997009|Drug|cetuximab|400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly
16251553|NCT00996996|Biological|Tositumomab and Iodine I 131 Tositumomab (Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody)|"Dosimetric Dose: 450 mg of Anti-B1 Antibody infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by 5 mCi (35 mg) of Iodine-131 Anti-B1 Antibody infused over 30 minutes (inclusive of a 10-minute flush).
~Therapeutic Dose: Seven to 14 days after the dosimetric dose, 450 mg of Anti-B1 Antibody infused over 70 minutes (inclusive of a 10-minute flush), immediately followed by the patient-specific milliCurie activity (35 mg) of Iodine-131 Anti-B1 Antibody to deliver a total body dose (TBD) of 75 cGy infused over 30 minutes (inclusive of a 10-minute flush). Obese patients were dosed based upon 137% of their calculated lean body mass."
16251554|NCT00996983|Drug|ziconotide|intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day
16251555|NCT00996957|Biological|ACE-041|Subcutaneous dose of ACE-041 approximately once every 3 weeks for a total of 4 doses. If disease stays the same or gets better, additional study drug may be offered.
16251556|NCT00996944|Drug|Ropinirole immediate release (IR)|"Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime. The maximum available dose is 3 mg/day. For all subjects completing short-term period and entering the long-term treatment period, the open-label treatment will be started from IR 0.25 mg/ day regardless of dose levels during short-term period. The dose will be upward titrated from 0.25 mg/day to 0.5 mg/day and after that in increments of 0.5 mg/day until sufficient efficacy is obtained (targeting much improved or very much improved in the CGI-I) without safety/tolerability problem."
16251557|NCT00996944|Drug|Placebo|Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime.
16251558|NCT00996931|Drug|lenalidomide|2.5 mgs per day orally for 12 weeks
16251559|NCT00996918|Drug|Bapineuzumab 0.5 mg/kg|Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
16251560|NCT00996918|Drug|Bapineuzumab 1.0 m/kg|I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
16251561|NCT00996905|Device|Portable ultrasound machine|Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
16251562|NCT00996905|Device|Portable ultrasound machine|Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
16251563|NCT00996892|Drug|Cobimetinib|Repeated oral dosing.
16251566|NCT00996879|Drug|BMS-791325|Capsules, Oral, 300 mg, Every 12 hours, 8 days
16251567|NCT00996866|Drug|Vitamin D3|Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
16251568|NCT00996866|Drug|placebo|The placebo group will receive sugar pills appearing similar to the vitamin D capsules.
16251569|NCT00996853|Other|Safety follow up|Collection of reactogenicity data from diary cards, reporting of medically-attended adverse events, reporting of serious adverse events and adverse events of special interest, reporting of pregnancy outcomes and fatalities.
16251570|NCT00996840|Drug|SB-681323 Intravenous 3mg|3 mg SB-681323 Intravenous administration infused over 4 hours
16251571|NCT00996840|Drug|SB-681323 Intravenous 7.5 mg|7.5 mg SB-681323 Intravenous administration infused over 24 hours
16251572|NCT00996840|Drug|SB-681323 Intravenous 7.5mg|7.5 mg SB-681323 Intravenous administration infused over 4 hours
16251573|NCT00996840|Drug|SB-681323 Intravenous 10mg|10 mg SB-681323 Intravenous administration infused over 24 hours
16251574|NCT00996840|Other|Placebo|Placebo to match intervention
16251575|NCT00996814|Behavioral|Proactive Ethics Intervention|The ethicist will: 1) meet with the patient or surrogate to assess the case and the decision-making capacity of the patient; 2) make an ethical diagnosis, framing the issues in easily understood ethical terms with the involved parties; 3) recommend the next steps, including measures to improve communication. The ethicist will help to articulate consensus or disagreement and either facilitate implementing the consensus or facilitate ways to address and resolve disagreements; 4) document the consultation in the patient's medical record, identifying the ethical issues identified, the steps taken to address those issues, the options and ethical rationales considered, the outcome and the future plan; 5) follow-up to provide ongoing support and record a follow up progress note in the chart; and 6) participate in evaluation.
16251576|NCT00996801|Drug|MK-5442|MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months
16251577|NCT00996801|Drug|Placebo to MK-5442|Matching placebo to MK-5442 taken orally, once-daily, for 12 months
16251578|NCT00996801|Drug|Alendronate Sodium|Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months
16251579|NCT00996801|Drug|Vitamin D3|Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months
16251580|NCT00996801|Drug|Calcium carbonate|Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months
16251581|NCT00996801|Drug|Placebo to Alendronate|Placebo to alendronate once-weekly for 12 months
16251582|NCT00996788|Drug|Rebamipide|Rebamipide 100 mg tid for 28 days
16251583|NCT00996775|Behavioral|brief alcohol intervention|this intervention consists of brief assessment and feedback
16251584|NCT00996775|Behavioral|standard care|education about harmful effects of alcohol use and NIAAA recommended drinking limits
16251585|NCT00996762|Drug|lapatinib|1250 mg or 1500 mg lapatinib commercial tablet
16251586|NCT00996749|Dietary Supplement|omega-3 fatty acid|Given PO
16251587|NCT00996749|Other|bone scan|Correlative studies
16251588|NCT00996749|Other|dual x-ray absorptometry|Correlative studies
16251589|NCT00996749|Other|laboratory biomarker analysis|Correlative studies
16251590|NCT00996749|Procedure|biopsy|Correlative studies
16251591|NCT00996736|Drug|Natamycin|5% natamycin plus 0.02% preservative, one drop to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until 3 weeks after enrollment.
16251592|NCT00996736|Drug|Voriconazole|1% voriconazole plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
16251593|NCT00996723|Drug|vandetanib and dasatinib|Two oral investigational agents (vandetanib [VEGFR2, RET, and EGFR inhibitor] and dasatinib [bcr-abl, PDGFRA and B, src, lck, yes, and c-kit inhibitor] will be administered during and after local RT, which is the only standard therapy for children with DIPG.
16251594|NCT00996697|Drug|Budesonide/formoterol and tiotropium|Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day
16251595|NCT00996697|Drug|Budesonide/formoterol and placebo|Symbicort 200/6 2puff bid and placebo
16251596|NCT00996684|Drug|Microplasmin|Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.
16251597|NCT00996684|Drug|Placebo control|The placebo control will be the microplasmin vehicle without the microplasmin.
16251598|NCT00996671|Drug|GSK2256098|focal adhesion kinase inhibitor given as a single dose
16251599|NCT00996671|Drug|Placebo|Placebo to be used as comparator for GSK2256098
16251600|NCT00996658|Drug|Placebo|Placebo matching linagliptin tablets once daily
16251601|NCT00996658|Drug|Linagliptin|Linagliptin tablets once daily
16251602|NCT00996645|Other|Worksheet to facilitate goal-setting and action plans|Developed based on goal-setting theory and implementation intentions, the worksheet will be mailed out with the feedback reports and is expected to facilitate improved quality of care in response to feedback reports.
16251603|NCT00996632|Procedure|ultrasonic knife (Ultracision®, Ethicon Endo Surgery)|mastectomy or quadrantectomy and axillary dissection by an ultrasonic knife (Ultracision®, Ethicon Endo Surgery)
16251604|NCT00996632|Procedure|conventional diarthermy knife|mastectomy or quadrantectomy and axillary dissection using conventional diarthermy knife
16251605|NCT00996619|Procedure|An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination|"An optical fiber, inside the work channel of an endoscope, connected to a spectroscope, enables measuring the spectrum of objects seen by the endoscope"
16251606|NCT00996606|Drug|DMARDs|Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol.
16251607|NCT00996606|Drug|Tocilizumab|Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.
16251647|NCT00996307|Biological|MF59-eH1N1_f|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
16251724|NCT00995774|Other|conventional functional training|12 sessions of conventional therapy for the arm and hand from a physical therapist
16251608|NCT00996593|Biological|Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)|Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
16251609|NCT00996580|Drug|DR-103|"One tablet daily.
~Four 91-day cycles of the DR-103 regimen:
~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE."
16251610|NCT00996567|Drug|Cetuximab (Erbitux)|Patients will be treated with standard chemotherapy (4-6 cycles), combined with weekly administration of Cetuximab (Erbitux) until disease progression.
16251611|NCT00996554|Procedure|double layer-suture|Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
16251612|NCT00996554|Procedure|Single-layer suture|Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)
16251613|NCT00996541|Behavioral|STRIVE family intervention|Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.
16251614|NCT00996528|Behavioral|Philani Intervention Program|Offered to pregnant women / mothers through mentor mothers, i.e. mothers in community who are selected because they are doing well. They are trained to conduct home visits, 2 times a months through pregnancy. After childbirth, visits are spaced depending on the perceived need. If the baby is thriving and mother is coping well with health risks, mentor mother will visit once a month.
16251615|NCT00996515|Drug|5-azacytidine, erlotinib|Erlotinib 150 mg PO daily, days 1-8, and 15-22 5-Azacytidine 75 mg/m2/day, IV days 1 and 15
16251616|NCT00996515|Drug|Erlotinib PO and Vidaza IV|Patients enrolled to 1 of 5 cohorts, with varying drug doses and dose scheduling.
16251617|NCT00996502|Drug|Docetaxel|"Phase I:
~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle"
16251618|NCT00996502|Drug|Bevacizumab|15mg/kg of Bevacizumab every 3 weeks
16251619|NCT00996502|Drug|Erlotinib|200 mg of Erlotinib PO daily days 2-16
16251620|NCT00996502|Drug|Prednisone|5 mg of Prednisone PO bid
16251621|NCT00996489|Device|Coaptite®|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
16251622|NCT00996476|Drug|TMC435|One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
16251623|NCT00996476|Drug|PegIFNα-2a|One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
16251624|NCT00996476|Drug|RBV|300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
16251625|NCT00996463|Procedure|Electro-thermo-coagulation|Electro-thermo-coagulation
16251626|NCT00996463|Drug|Sodium Stibogluconate|Intralesional injection of sodium stibogluconate
16251627|NCT00996463|Drug|DAC N-055|Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
16251628|NCT00996437|Drug|Ranibizumab|Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
16251629|NCT00996437|Drug|Saline|Saline injection of 0.5mg at baseline, 4 and 8 weeks
16251630|NCT00996424|Drug|Acetylcysteine|Inhalation with N-Acetylcysteine
16251631|NCT00996424|Drug|normal saline|Inhalation with normal saline solution
16251632|NCT00996411|Drug|Salvinorin A|This is an initial dose ranging study
16251633|NCT00996398|Other|Tepid water immersion|28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus
16251634|NCT00996385|Drug|Velcade (bortezomib) plus Eloxatin (oxaliplatin)|One cycle is defined as an interval of 28 days. A cycle is comprised of four treatments of Velcade (Bortezomib) 1.3 mg/m2 given on days 1, 14, 15, and 18 and two treatments of Eloxatin (Oxaliplatin) 85 mg/m2 on days 4 and 18.
16251635|NCT00996372|Drug|flibanserin|patients will be randomized to flibanserin or placebo in a double-blind manner
16251636|NCT00996372|Drug|placebo|patients will be randomized to flibanserin or placebo in a double-blind manner
16251637|NCT00996359|Biological|Irradiated haploidentical allogeneic lymphocytes|Partially HLA-matched irradiated donor lymphocytes will be infused after total body irradiation.
16251638|NCT00996359|Radiation|total-body irradiation|100 cGy TBI
16251639|NCT00996346|Drug|Irinotecan&Temsirolimus:Arm1, Level 1|Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
16251640|NCT00996346|Drug|Irinotecan&Temsirolimus:Arm 1, Level 2|Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
16251641|NCT00996346|Drug|Irinotecan&Temsirolimus:Arm 2, Level 1|Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
16251642|NCT00996333|Drug|Gemcitabine, Docetaxel, Capecitabine|"1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
16251643|NCT00996320|Other|Reduced work hour schedule|Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.
16251644|NCT00996307|Biological|MF59-eH1N1_f|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
16251645|NCT00996307|Biological|MF59-eH1N1_f|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
16251646|NCT00996307|Biological|MF59-eH1N1_f|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
16251648|NCT00996294|Procedure|biliopancreatic diversion, gastric bypass|biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop
16251649|NCT00996281|Drug|Azilsartan medoxomil and chlorthalidone|Combination tablet.
16251650|NCT00996281|Drug|Olmesartan medoxomil and hydrochlorothiazide|Combination tablet.
16251651|NCT00996268|Drug|GSK2212836|Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.
16251652|NCT00996268|Drug|GSK2212836|Treatment D - low dose of GSK2212836 test formulation, Treatment E - medium dose of GSK2212836 test formulation, Treatment F - high dose of GSK2212836 test formulation, Treatment G - GSK2212836 marketed formulation, or Placebo.
16251653|NCT00996255|Drug|PHA-793887|Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.
16251654|NCT00996242|Drug|L-lysine|6 g/day for four weeks
16251655|NCT00996229|Behavioral|Caloric restriction|20-30% CR for 6 months
16251656|NCT00996229|Dietary Supplement|Omega-3 (fish oil capsules)|2g/day DHA/EPA capsules for 6 months
16251657|NCT00996229|Dietary Supplement|Placebo|Daily corn oil capsules for 6 months
16251658|NCT00996229|Dietary Supplement|Resveratrol|daily resveratrol for 6 months
16251659|NCT00996216|Drug|Eltrombopag|Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
16251660|NCT00996216|Drug|Antiviral therapy|Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
16251661|NCT00996203|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks for 24 weeks
16251662|NCT00996203|Drug|DMARDs (disease-modifying antirheumatic drugs)|stable doses at investigator's prescription
16251663|NCT00996190|Drug|Phenylephrine|phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
16251664|NCT00996177|Drug|IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem|40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
16251665|NCT00996177|Drug|IV Morphine Patient-Controlled Analgesia (IV PCA)|20mg/2hr (240 mg during 24 hours)
16251666|NCT00996164|Drug|Flibanserin|patients will be randomized to flibanserin or placebo in a double-blind manner
16251667|NCT00996164|Drug|Placebo|patients will be randomized to flibanserin or placebo in a double-blind manner
16251668|NCT00996151|Drug|Testosterone MD-Lotion|Single dose Testosterone MD-Lotion 2%
16251669|NCT00996138|Biological|Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine|High dose group and low dose group of adjuvanted vaccines
16251670|NCT00996125|Biological|CervarixTM|Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.
16251671|NCT00996125|Other|Control|Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.
16251672|NCT00996099|Device|Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment|Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery
16251673|NCT00996099|Other|Intensive insulin therapy using standard protocol|Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.
16251674|NCT00996086|Device|CRT device implant|CRT device-recipients
16251675|NCT00996073|Biological|Lumbar Interbody Fusion with Autograft|Single Dose Autograft Surgical Implantation
16251676|NCT00996073|Biological|Lumbar Interbody Fusion with NeoFuse|Single Dose NeoFuse Surgical Implantation
16251677|NCT00996073|Biological|Lumbar Interbody Fusion with NeoFuse|Single Dose NeoFuse Surgical Implantation
16251678|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort -1|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~In this cohort, Hydralazine is administered at 10 mg/day."
16251679|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 0|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 25 mg/day in this cohort."
16251680|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 1|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 50 mg/day in this cohort."
16251681|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 2|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 100 mg/day in this cohort as 25 mg four times per day."
16251682|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 3|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 200 mg/day in this cohort as 50 mg four times per day."
16251683|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 4|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 300 mg/day in this cohort as 75 mg four times per day."
16251722|NCT00995774|Other|conventional functional training|12 sessions of conventional therapy for the arm and hand from a physical therapist
16251723|NCT00995774|Device|robotic therapy|12 sessions of robot therapy for arm and hand function
16254203|NCT00978549|Procedure|standard follow-up care|
16251684|NCT00996060|Drug|Hydralazine and Valproic Acid: Cohort 5|"Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
~Hydralazine is administered at 400 mg/day in this cohort as 100 mg four times per day."
16251685|NCT00996047|Genetic|cytogenetic analysis|
16251686|NCT00996047|Genetic|fluorescence in situ hybridization|
16251687|NCT00996034|Biological|NicVAX|1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
16251688|NCT00996034|Radiation|[123I]5-IA-85380|up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days
16251689|NCT00996034|Drug|Nicotine bitartrate|0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
16251690|NCT00996021|Drug|GSK1349572 250 mg|This is an experimental HIV medication in the integrase inhibitor class.
16251691|NCT00996021|Drug|Placebo Suspension|Placebo is a liquid with no drug in it.
16251692|NCT00996021|Drug|Moxifloxacin 400 mg|This is an FDA approved antibiotic in the fluoroquinolone class.
16251693|NCT00996008|Drug|placebo|0.5 g (w/w) placebo cream applied to each target lesion twice daily
16251694|NCT00996008|Drug|CT 327|0.5 g CT 327 cream will be applied to 2 target lesions twice daily 0.5 g placebo cream will be applied to remaining 2 target lesions twice daily
16251695|NCT00995995|Drug|Rosiglitazone|Rosiglitazone
16251696|NCT00995982|Biological|VRC-FLUDNA056-00VP|
16251697|NCT00995969|Drug|placebo|1.0 g (w/w) placebo cream applied to both target lesions twice daily
16251698|NCT00995969|Drug|CT 327|1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily
16251699|NCT00995930|Drug|ACZ885|ACZ885 150 mg was administered subcutaneously once a month for 12 months.
16251700|NCT00995930|Drug|Placebo|Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
16251701|NCT00995917|Other|Vitamin K acupoint injection|Vitamin K will be injected into an acupuncture point within 2 days of the onset of painful menstrual cramps. Injections of 5 mg/0.5ml of vitamin K1 will be administered in bilateral acupuncture points. A single shot of vitamin K1 is 10mg/ml. Five mg/0.5ml will be drawn twice from one ampule and injected into each bilateral site, for a total dose of 10mg/ml of vitamin K.
16251702|NCT00995917|Other|Saline Injection|Injection of .5ml saline bilaterally into both legs within 2 days of the onset of painful menstrual cramps.
16251703|NCT00995904|Drug|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
16251704|NCT00995904|Drug|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
16251705|NCT00995904|Drug|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
16251706|NCT00995878|Procedure|Focused ultrasound (MRgFUS)|MRgFUS treatment will take place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid or fibroids. No incision is made during this treatment and light sedation is required. There are certain fibroids that may not be treated with this technique and there is no treatment of normal uterine tissue.ough the abdominal wall to destroy the fibroid.
16251707|NCT00995878|Procedure|Uterine artery embolization (UAE)|UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to use very small pellets to block off the blood supply to the entire uterus. Sedation is used. Most fibroids are treated with this technique and normal uterine tissue is also affected.
16251708|NCT00995865|Biological|XRX-001 Inactivated yellow fever vaccine|Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
16251709|NCT00995865|Biological|Placebo|NaCl Injectable 0.9%
16251710|NCT00995852|Device|IBV Implantation|"In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of new air during inspiration"
16251711|NCT00995852|Device|IBV Implantation|"In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of new air during inspiration"
16251712|NCT00995839|Drug|continuous infusion of terlipressin|Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs
16251713|NCT00995839|Drug|Arginine vasopressin|Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs
16251714|NCT00995839|Drug|terlipressin bolus administration|intravenous terlipressin bolus administration at the dose of 0.5 mg
16251715|NCT00995826|Drug|CS-8958|Inhaled CS-8958
16251716|NCT00995826|Other|Placebo|Inhaled placebo
16251717|NCT00995813|Biological|Rotarix|A rotavirus vaccine (Rotarix) will be administered in two doses, 8 weeks apart, in infants between 6 and 14 weeks of age. The standard dosage is 1 mL administered orally or per gastrostomy tube.
16251718|NCT00995800|Drug|Fluticasone propionate / Formoterol fumarate|2 dose strength vs. placebo
16251719|NCT00995787|Drug|AZD1656|Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
16251720|NCT00995787|Drug|Placebo|Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
16251721|NCT00995774|Device|robotic therapy|12 sessions of robot therapy for arm and hand function
16254204|NCT00978549|Radiation|radiation therapy|
16251725|NCT00995761|Drug|Docetaxel and Cisplatin|splitted administration of docetaxel and cisplatin.
16251726|NCT00995735|Procedure|Cholecystectomy|Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
16251727|NCT00995735|Procedure|Appendectomy|Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
16251728|NCT00995722|Drug|Prednisone|Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.
16251729|NCT00995722|Drug|Placebo|Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.
16251730|NCT00995709|Drug|AIN457|
16251731|NCT00995709|Drug|AIN457|
16251732|NCT00995709|Drug|Placebo|
16251733|NCT00995696|Behavioral|PhaST IVR Calls|Participants in this condition receive 7 computer automated IVR calls.
16251734|NCT00995683|Drug|half molar sodium lactate|intravenous infusion of 0.5 ml/kg during 48 hours
16251735|NCT00995683|Drug|isotonic sodium chloride|intravenous infusion of 0.5 ml/kg during 48 hours
16251736|NCT00995670|Drug|5% dextrose|Glucose is infused to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent ischemia/reperfusion injury.
16251737|NCT00995670|Drug|Vitamin C|Vitamin C is intended to restore the impairment of the endothelium caused by the dextrose infusion.
16251738|NCT00995670|Drug|Simvastatin|Simvastatin will be ingested to determine the efficacy of a statin to modulate the forearm response to glucose.
16251739|NCT00995670|Drug|Sevoflurane|Sevoflurane will be given to attenuate or prevent the I/R injury during glucose.
16251740|NCT00995657|Drug|Fluticasone Propionate|Inhaled Fluticasone Propionate 50mcg bid
16251741|NCT00995657|Drug|Fluticasone Propionate|Inhaled Fluticasone Propionate 250mcg bid
16251742|NCT00995631|Procedure|Femoral lipectomy|Standard (non-experimental) suction assisted liposuction surgery
16251743|NCT00995618|Drug|Tranilast|Tranilast tablets, 300 mg, QD
16251744|NCT00995618|Drug|Febuxostat|Febuxostat Tablets, 40 mg, QD
16251745|NCT00995618|Drug|Combination - Tranilast and Febuxostat|Tranilast, 300 mg QD; Febuxostat, 40 mg QD
16251746|NCT00995605|Drug|AMAP102|AMAP102 or Placebo
16251747|NCT00995592|Behavioral|Philani nutrition intervention program (mentor mothers)|Behavioral intervention was offered through mentor mothers. Mentors were mothers in community who were selected by because they were doing well. They were trained to conduct home visits, up to 16 times over one year period, ranging from 20 minutes to 2 hours. Mentor mothers worked to improve health of mother and their child and build social support in neighborhood.
16251748|NCT00995566|Drug|Sitaxentan sodium|Please note that this is a non-interventional study and no drug is actually given as an intervention. Instead, patients prescribed THELIN are being followed under real world circumstances. However at the request of the QA group at CT.gov, we were instructed to add sitaxentan sodium as the intervention type, regardless of the fact that this is a non-interventional study.
16251749|NCT00995553|Behavioral|Cognitive Remediation|This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months.
16251750|NCT00995553|Behavioral|Computer Skills|This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months.
16251751|NCT00995540|Drug|INGAP Peptide|100 mg INGAP Peptide tid subcutaneous injection for 12 weeks
16251752|NCT00995540|Drug|INGAP Peptide|200 mg INGAP Peptide tid subcutaneous injection for 12 weeks
16251753|NCT00995540|Drug|Placebo|Placebo tid subcutaneous injection for 12 weeks
16251754|NCT00995501|Drug|Dexamethasone Sodium Sulfate|8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
16251755|NCT00995501|Drug|Insulin|Insulin to maintain blood glucose 80-110 mg/dl.
16251756|NCT00995501|Drug|anesthesia management|Light anesthesia to maintain BIS about 55
16251757|NCT00995501|Other|Dexamethasone - placebo|8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
16251758|NCT00995501|Other|Insulin - Placebo|Insulin to maintain blood glucose 180-200 mg/dl.
16251759|NCT00995501|Other|Anesthesia management -Placebo|Deep anesthesia to maintain BIS about 35
16251760|NCT00995488|Drug|ABI-007 (Abraxane®)|ABI-007 is a novel albumin-bound paclitaxel combining a protein with a chemotherapeutic agent in the particle form.
16251761|NCT00995475|Drug|Fluticasone propionate|
16251762|NCT00995475|Drug|Placebo|
16251763|NCT00995462|Behavioral|Lifestyle intervention seminars|The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts. A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.
16251764|NCT00995449|Biological|KB003|KB003 IV x5 doses
16251765|NCT00995449|Other|Placebo Comparator|Placebo IV x5 doses
16251766|NCT00995436|Device|Extraoral anchorage|Extra oral anchorage
16251767|NCT00995436|Device|Miniscrews|Intraoral skeletal anchorage using mini screws
16251768|NCT00995436|Device|Nance|Intraoral dental anchorage by using Nance palatal arch on molars
16251769|NCT00995423|Device|CoroflexTM Please|highly flexible CoroflexTM Please-Stent
16251770|NCT00995423|Device|Paclitaxel-eluting stent|Paclitaxel-eluting stent
16251771|NCT00995410|Drug|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily
16251772|NCT00995397|Drug|Dexchlorpheniramine 1% lotion|Small amount applied over the lesion twice a day for 7 days.
16251773|NCT00995397|Drug|Dexchlorpheniramine 1% cream|Small amount applied over the lesion twice a day for 7 days.
16251774|NCT00995384|Procedure|CT Scan|Cardiac CT with special attention to valves in Endocarditis patients.
16254251|NCT00978263|Drug|metformin-based Oral Antidiabetic Drugs|
16251775|NCT00995371|Device|MILD® (Minimally Invasive Lumbar Decompression)|Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
16251776|NCT00995371|Drug|Epidural Steroid Injection|An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.
16251777|NCT00995358|Biological|peptide|Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
16251778|NCT00995345|Drug|KRP-104|Tablet
16251779|NCT00995345|Drug|Placebo|Tablet
16251780|NCT00995332|Drug|Cytarabine, all-trans retinoic acid, valproic acid|ATRA: 22.5 mg/m2 twice daily for 2 weeks every third month Valproic acid: continuous therapy, dosage guided by serum levels Cytarabine: 10 mg/m2 once daily for up to 10 days every third month
16251781|NCT00995306|Drug|Civamide (Zucapsaicin)|"Civamide Cream 0.075%, TID for 12 weeks
~Civamide Cream 0.01%, TID for 12 weeks"
16251782|NCT00995293|Drug|DOCETAXEL|Intravenous
16251783|NCT00995293|Drug|CISPLATIN|Intravenous
16251784|NCT00995293|Drug|5-FLUOROURACIL|Intravenous
16251785|NCT00995280|Device|single lumen needle oocyte retrieval|single lumen needle use during oocyte retrieval
16251786|NCT00995280|Device|double lumen needle oocyte retrieval|double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval
16251787|NCT00995267|Behavioral|parent-child interaction/activities based on Adler's methods|"Description of the Intervention:
~5 joint classroom activities (parents and children together, involving children in food choices/food preparation-sense of belonging/decision making): 1. Healthy breakfasts and 10 o'clock snacks 2. Fats and oils in the diet, cooking methods, setting limits to oily food intake. 3. Fruit and vegetables in the daily diet, adults as role models. 4. Learning about food categories & pyramid, healthy eating and growth. 5. Limiting consumption of sweets and snacks.
~Workshop for Parents: Explaining nutritional needs of children; how to encourage good eating habits, how to deal with children's manipulations, providing tools to elicit change; use of food to attract parental attention; practical tools to deal with their children's eating habits/obesity/refusal to eat/chronic health problems/failure to grow; ways to prevent use of food as an answer to childhood frustrations."
16251788|NCT00995254|Behavioral|SHI counseling|The SHI will be delivered in three different individualized counseling sessions: the initial in person counseling (30-45 minutes), at 1 week in person or telephone counseling (15-30 minutes) and at 1 month in person counseling (15-30 minutes). During the initial counseling, CHWs will emphasize the health hazards of SHS exposure towards young children and its possible illness outcomes. Then subjects will be asked to assess the SHS exposure of children in the household (e.g., estimating the number of hours for SHS exposure on the child per week or day) and the source of SHS. The concept of smoking hygiene and non-smoking household policy will be discussed and any potential barriers ascertained. Furthermore, the CHWs will use the transtheoretical model of Prochaska to assess the stage of readiness of the household member to change smoking behavior existing in the household. Individuals who wish to quit smoking will receive a brief advice on quitting smoking.
16251789|NCT00995241|Drug|Raltegravir|Raltegravir 800 mg / 24 hours.
16251790|NCT00995215|Procedure|Spinal Cord Stimulation|The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.
16251791|NCT00995215|Device|Expiratory Muscle Stimulator|The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
16251792|NCT00995202|Procedure|Standard Monitoring CEA|No specific follow-up of CEA
16251793|NCT00995202|Procedure|Intensive Monitoring CEA|CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
16251794|NCT00995202|Procedure|Standard Monitoring Imagery|Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years
16251795|NCT00995202|Procedure|Intensive Monitoring Imagery|Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal
16251796|NCT00995189|Device|Opti-Free RepleniSH|Contact lens care solution containing polyquaternium-1 (PQT)
16251797|NCT00995189|Device|ReNu MultiPlus|Contact lens care solution containing polyhexamethylene biguanide (PHMB)
16251798|NCT00995189|Device|Contact lenses|Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
16251801|NCT00995137|Biological|NK Cell Infusion|Infusing genetically modified NK cells into research participants who have chemotherapy refractory or relapse B-lineage ALL.
16251802|NCT00995124|Drug|NeutraLice Lotion|Head lice topical application to be applied once for 10 minutes.
16251803|NCT00995124|Drug|NeutraLice Advance Solution|head lice application to be applied once for 10 minutes
16251804|NCT00995124|Drug|Moov Head Lice Solution|Single application for head lice with 10 min application time.
16251805|NCT00995098|Dietary Supplement|early enteral nutrition|Enteral nutrition will be administered within 24 hours of admission through naso-jejunal tube and continue for 7 days after admission. Naso-jejunal tube will be set up by endoscopy. X-ray will be used to place the distal end of the feeding tube and EN would not start until the distal end of the feeding tube has been placed at the remote end of Treitz ligament. Standard enteral nutrition liquid regimen (Nutrison Fibre) will be used. Patients are targeted to receive calories for 25 kcal/kg/day and nitrogen for 0.2g/kg/day.
16251844|NCT00994890|Drug|Tanezumab 10 mg|Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
16251845|NCT00994864|Drug|FOLFOX|One cycle of standard FOLFOX pre-operatively followed by 11 cycles of standard adjuvant FOLFOX chemotherapy.
16251846|NCT00994851|Drug|SENNA+CASSIA|Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
16251806|NCT00995098|Dietary Supplement|Parenteral nutrition|PN administration will start within 12 hours of admission and continue for 7 days after admission. Patients will receive calories for 25 kcal/kg and nitrogen for 0.2g/kg. Twenty percent of the calories will be provided by fat emulsion (LCT/MCT) and the remaining will be provided by dextrose. Nitrogen will be provided by balanced amino acids injection (Novamin). All PN components will be compounded into 3-liters bags under sterile conditions. Nutrition regimen will be administered through subclavian central venous catheter.
16251807|NCT00995085|Drug|Extended Release Metadoxine|one oral 1400mg dose (2 tablets)
16251808|NCT00995072|Drug|nebivolol and metoprolol succinate|Subjects randomized to treatment Arm A will receive nebivolol 5 mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm A will then receive metoprolol succinate 100 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
16251809|NCT00995072|Drug|metoprolol succinate and nebivolol|Subjects randomized to treatment Arm B will receive metoprolol succinate 100mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm B will then receive nebivolol 5 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
16251810|NCT00995059|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo transplantation
16251811|NCT00995059|Procedure|allogeneic bone marrow transplantation|Undergo transplantation
16251812|NCT00995059|Drug|bortezomib|Given IV
16251813|NCT00995059|Drug|melphalan|Given IV
16251814|NCT00995059|Drug|anti-thymocyte globulin|Given IV
16251815|NCT00995059|Drug|sirolimus|Given orally
16251816|NCT00995059|Drug|tacrolimus|Given oral or IV
16251817|NCT00995059|Radiation|total-body irradiation|Undergo total-body irradiation
16251818|NCT00995046|Drug|FVIII|6 months of prophylaxis treatment administered 3 or 4 times weekly according to patient's initial regimen, (standardized Malmö protocol 25 - 40 IU/kg/infusion). Medical visits will occur at 3-month intervals (+ 5 days) until the end of the study. Weekly, telephone calls to the patients (parents) will also be done.
16251819|NCT00995046|Drug|FVIII|"1 month period where thrombin generating capacity will be evaluated, followed by 6 months of individually tailored prophylaxis regimen according to TGT results. Medical visits will occur at 3-month intervals (+ 5 days) until the end of the study. Weekly, telephone calls to the patients (parents) will also be done."
16251820|NCT00995033|Biological|NicVAX vaccine|NicVAX vaccine given 6 times over 6 months
16251821|NCT00995033|Biological|Placebo|Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months
16251822|NCT00995033|Drug|Varenicline|Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)
16251823|NCT00995020|Procedure|Straight Wire Excision of Transformation Zone|Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
16251824|NCT00995020|Procedure|Large Loop Excision of Transformation Zone (cone biopsy)|LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth. The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.
16251825|NCT00995007|Drug|ZD6474 (Vandetanib)|Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
16251826|NCT00995007|Drug|Carboplatin|Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
16251827|NCT00994994|Drug|Tranexamic Acid|50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.
16251828|NCT00994981|Drug|magnesium|Thirty minutes after the beginning of the anhepatic phase, the patients were received a magnesium solution (MgSO4 25 mg•kg-1 mixed in 100 ml of normal saline) over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.
16251829|NCT00994981|Drug|normal saline|Thirty minutes after the beginning of the anhepatic phase, the patients were received 100 ml of normal saline over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.
16251830|NCT00994968|Drug|cyclophosphamide|
16251831|NCT00994968|Drug|docetaxel|
16251832|NCT00994968|Drug|doxorubicin hydrochloride|
16251833|NCT00994968|Drug|tegafur-gimeracil-oteracil potassium|
16251834|NCT00994968|Procedure|neoadjuvant therapy|
16251835|NCT00994968|Procedure|therapeutic conventional surgery|
16251836|NCT00994955|Device|selective retina therapy (SRT)|laser treatment
16251837|NCT00994942|Drug|morphine sulfate|morphine sulfate 30 mg tablet, morphine sulfate 30 mg (10 mg / 5 mL) oral solution, morphine sulfate injection 10 mg (1 mg / mL)
16251838|NCT00994929|Biological|Neumega (Oprelvekin, Interleukin 11, IL-11)|25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
16251839|NCT00994916|Drug|3,4 diaminopyridine|3,4 diaminopyridine up to 80 mg daily in divided doses
16251840|NCT00994903|Drug|Simvastatin|40mg orally, given 3-7 days pre-op and continued till 14 days post-op
16251841|NCT00994903|Drug|Placebo|Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
16251842|NCT00994890|Drug|Tanezumab 2.5 mg|Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
16251843|NCT00994890|Drug|Tanezumab 5 mg|Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
16254252|NCT00978263|Drug|Glargine|
16251847|NCT00994851|Drug|placebo|Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
16251848|NCT00994838|Other|reduced calorie diet|10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
16251849|NCT00994825|Drug|Levosimendan|
16251850|NCT00994825|Drug|placebo|"Soluvit ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%"
16251851|NCT00994812|Drug|metformin|The obese women will be randomized either to metformin (2g/day) or to placebo, and the non-obese either to metformin (1.5g/day) or to placebo. All subjects will be evaluated 1 to 7 days after spontaneous menstruation (oligomenorrheic patients), or at any other convenient time (amenorrheic subjects). After the treatment of 3 months with metformin/placebo alone, another appropriate infertility treatment will be combined with metformin/placebo (clomiphene, ovulation induction, insemination or in vitro fertilization) if no pregnancy has occurred. This treatment will be continued another 6 months' period. If pregnancy occurs, subjects will be re-examined at 7-8 weeks of gestation.
16251852|NCT00994799|Drug|ranibizumab|10mg/ml intravitreal injection
16251853|NCT00994799|Radiation|macular grid-pattern laser|macular grid-pattern laser therapy
16251854|NCT00994786|Drug|pregabalin|pregabalin starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin will be 600 mg/day.
16251855|NCT00994786|Drug|Placebo|Placebo starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin/placebo will be 600 mg/day.
16251856|NCT00994773|Drug|Simvastatin|daily doses for 14 days
16251857|NCT00994773|Drug|Tenofovir|
16251858|NCT00994773|Drug|Entecavir|Entecavir
16251859|NCT00994760|Drug|Instanyl (Intranasal Fentanyl)|This was an observational study. Therefore, the physician decided about dosage according to individual needs.
16251860|NCT00994747|Other|Nutramigen (Flavor and Type of Infant Formula)|Nutramigen, protein hydrolysate formula, fed to infants as sole formula source during specified times during the first 8.5 months of life
16251861|NCT00994747|Other|Enfamil, milk-based formula|Enfamil, milk-based formula, fed as formula source during first 8.5 months of life
16251862|NCT00994734|Drug|Mifepristone|home administration of mifepristone
16251863|NCT00994708|Drug|esomeprazole|
16251864|NCT00994695|Biological|Mencevax ACW Vaccine|Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).
16251865|NCT00994682|Drug|Pioglitazone study drug|30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months
16251866|NCT00994682|Drug|Placebo|An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.
16251867|NCT00994682|Drug|Pioglitazone Open Label|Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design.
16251868|NCT00994656|Device|Masimo multi-wavelength pulse co-oximeter|Subjects will have a finger probe that will measure the pleth variability index. They will also have an arterial line (as standard of care) from which arterial pulse tracings will be obtained.
16251869|NCT00994643|Biological|Rituximab|Given IV
16251870|NCT00994643|Biological|Interleukin-2|Given SC
16251871|NCT00994617|Drug|Losartan and hydrochlorothiazide|Losartan 50 -100mg Hydrochlorothiazide 12.5mg -25mg
16251872|NCT00994617|Drug|Hydrochlorothiazide switched over with Losartan at 8 weeks|Hydrochlorothiazide 12.5-25mg crossed over with Losartan 50-100mg
16251873|NCT00994604|Drug|broccoli sprout extract|consumption of broccoli sprout extract for 2 weeks
16251874|NCT00994591|Drug|Pharmacokinetic dosing|Pharmacokinetic testing involves dosing with deuterated cotinine which has an associated IND#61329.
16251875|NCT00994578|Behavioral|CHESS|Patients randomized to the CHESS intervention will be trained to access the website. After being trained in usage of the site, they will use the available resources as desired without further input from the study team, except for technical support
16251876|NCT00994578|Behavioral|COPE|Participants in the COPE arm will receive training and access to the COPE patient intervention, an interactive web program based on Social Cognitive Theory that includes automated, tailored email reminders and encouragement prior to each of two oncologists visits over a maximum of a 9 month period, and access to the patient's audio-recorded conversations for review.
16251877|NCT00994578|Behavioral|CHESS/COPE|Participants in the CHESS/COPE arm will be given access to the University of Wisconsin CHESS modified specifically for this study. After being trained in usage of the site, they will use the available resources as desired and receive technical support. COPE arm will receive training and access to the COPE patient intervention an interactive web program based on Social Cognitive Theory that includes automated, tailored email reminders and encouragement prior to two oncologists visits over a maximum period of 9 months, and access to the patient's audio-recorded conversations for review.
16251878|NCT00994565|Behavioral|Activity monitoring and distance counseling|The physical activity monitoring and distance counseling concept combines the use of a personal activity monitor with web-based tailored physical activity advice. Users can interactively plan and evaluate their own activity advice based on their actual PA scores and their PA preferences and goals.
16251879|NCT00994552|Other|Pressure support ventilation|Pressure support ventilation
16251880|NCT00994552|Other|Pressure control ventilation|Pressure control ventilation
16251881|NCT00994539|Drug|morphine sulfate|morphine sulfate 15 mg and 30 mg tablets
16251882|NCT00994526|Other|Ham|Ham : 180 g per day during 4 days
16251883|NCT00994526|Other|Ham + calcium|Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
16251884|NCT00994526|Other|Ham + vitamin E|Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days
16251885|NCT00994513|Dietary Supplement|Alpha Lipoic Acid|1200 mg/day
16251886|NCT00994513|Dietary Supplement|Placebo|1200 mg/day
16251891|NCT00994487|Other|High Energy Density Preload|Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles
16251892|NCT00994487|Other|Low Energy Density Preload|Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles.
16251893|NCT00994474|Procedure|Fractional carbon dioxide laser treatment|With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.
16251894|NCT00994474|Procedure|Fractional Er:YAG laser treatment|The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.
16251895|NCT00994461|Drug|Celecoxib|Celecoxib 100mg tablet twice a day with meal for 2 weeks
16251896|NCT00994461|Drug|Loxoprofen|Loxoprofen 60mg tablet three times a day with meal for 2 weeks
16251897|NCT00994461|Drug|Placebo|Placebo tablet three times a day with meal for 2 weeks
16251898|NCT00994448|Drug|Bupropion SR 150mg tabs|Bupropion SR 150mg tabs (Zyban) twice daily
16251899|NCT00994448|Drug|Placebo tablets|One placebo tablet twice daily
16251900|NCT00994422|Drug|Ivermectin cream|Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1.
16251901|NCT00994422|Drug|vehicle control|Up to 4 ounces of vehicle control applied to the hair and scalp on day 1
16251902|NCT00994396|Dietary Supplement|Placebo|Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos.
16251903|NCT00994396|Dietary Supplement|Vitamin D 3 cholecalciferol|4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.
16251904|NCT00994383|Drug|morphine sulfate|morphine sulfate 30 mg tablet, morphine sulfate 15 mg tablet, morphine sulfate controlled release 120 mg
16251905|NCT00994357|Device|Real-time CGM|See previous description.
16251906|NCT00994357|Other|Standard care|See text.
16251907|NCT00994344|Drug|Darunavir/ritonavir|Darunavir/ritonavir 800/100 mg once daily
16251908|NCT00994344|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 400/100 mg twice daily
16251909|NCT00994331|Procedure|Percutaneous coronary intervention|non surgical procedure to open blocked coronary arteries
16251910|NCT00994318|Drug|FCM (Ferric carboxymaltose) high ferritin target|
16251911|NCT00994318|Drug|FCM (Ferric carboxymaltose) low ferritin target|
16251912|NCT00994318|Drug|Oral Iron (Ferrous sulphate)|
16251913|NCT00994305|Drug|N-acetylcysteine|600 mg bid po 0-7 PO
16251914|NCT00994305|Drug|control|No treatment: standard care provided. No N-acetylcysteine administration.
16251915|NCT00994292|Drug|YM150|oral
16251916|NCT00994292|Drug|Placebo|oral
16251919|NCT00994266|Dietary Supplement|Diamel|Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.
16251920|NCT00994266|Dietary Supplement|Placebo|Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.
16251921|NCT00994253|Drug|Aliskiren|Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.
16251922|NCT00994253|Drug|Hydrochlorothiazide|Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily
16251923|NCT00994240|Procedure|Electrodessication & Curettage|Electrodessication & Curettage 1 or 3 cycles
16251924|NCT00994227|Procedure|vitrectomy for macular disease|three-port pars plana vitrectomy was performed in each case using a vitreous cutter surrounded by a coaxial optic fiber connected to a xenon light source (Lausanne set, Oertli, Switzerland-developed at Jules Gonin, Lausanne, by Gonvers and Bovey). Separation of the posterior hyaloid membrane was performed when necessary. Visualization of the fundus was achieved with a special noncontact wide-angle viewing system 37 during vitrectomy and with a planoconcave contact lens for macular peeling. The MEM was peeled in the macular area using an end gripping forceps.
16251925|NCT00994214|Drug|BIM 23A760|Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
16251926|NCT00994201|Other|DCE-MRI, DW-MRI and MRS|"Patients will undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), Diffusion-weighted magnetic resonance imaging (DW-MRI), Magnetic resonance spectroscopy (MRS) prior to the initiation of chemoradiation and before their second cycle of chemotherapy.
~Healthy volunteers will undergo DCE-MRI, DW-MRI and MRS."
16251927|NCT00994188|Procedure|Restored Kidney Transplant Between Family Members|Tumor part of the kidney or ureter and ureteral stricture is surgically removed or repaired and the kidney is restored and transplanted to a family member recipient
16251928|NCT00994175|Drug|Pioglitazone|
16251929|NCT00994175|Drug|Placebo|
16251930|NCT00994162|Device|EZCARE Negative Pressure Wound Therapy System|Vacuum Source and dressing kit that generates negative pressure over the wound.
16251931|NCT00994149|Drug|Diazoxide|10mg/kg/d divide every 8 hours
16251932|NCT00994149|Drug|Ora-plus|placebo, give every 8 hours.
16251933|NCT00994136|Drug|normal saline|Ten milliliters of normal saline will be injected at the end of the intravenous therapy. Injection is performed with the start/stop method and with the positive pressure technique (clamping the catheter while injecting the last milliliters of normal saline)
16251934|NCT00994123|Drug|MM-121|MM-121 (SAR256212) = intravenous solution
16251935|NCT00994123|Drug|Erlotinib|erlotinib = daily oral tablet
16251936|NCT00994110|Drug|Pasireotide (SOM230)|"Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
16251937|NCT00994110|Other|placebo|"Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.
~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
16251938|NCT00994097|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
16251939|NCT00994097|Drug|Cisplatin|Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles
16251940|NCT00994097|Drug|Gemcitabine|Gemcitabine: 1,250 mg/m² intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles
16251941|NCT00994097|Drug|Pemetrexed|Pemetrexed: 500 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles
16251942|NCT00994084|Behavioral|Healthy Kids-Houston program|Children receive 90 minutes of after-school structured physical activities and 30 minutes of nutrition and behavior lessons twice a week during three 6-week sessions at the community centers. The 6-week sessions take place once in the fall, once in early spring and once in late spring.
16251943|NCT00994084|Behavioral|Control|Children do not receive the Healthy Kids-Houston behavior modification program but will participate in the regular after-school enrichment programs offered by the community centers.
16251944|NCT00994071|Drug|Temozolomide|
16251945|NCT00994071|Drug|ABT-888|
16251946|NCT00994058|Device|Electrical Inhibition (EI) Uterine Pacemaker|"An external powered pulse generator, pacemaker for external stimulation of the uterine muscle through the vaginal canal for the therapeutic use of preventing preterm birth.
~Patients with preterm contractions (< 37 weeks gestation) will be monitored for contraction frequency for 20 minutes before, 20 minutes during use of EI and 20 minutes after EI/uterine inhibitor/pacemaker. Device generates a weak electrical current (0-10mA, 0-50 Hz, 0-50mS)."
16251947|NCT00994045|Biological|Fibrinogen concentrate|Fibrinogen concentrate will be administered initially at 2 grammes per hour by continuous infusion. This rate will be adjusted in response to the clinical picture and results of point of care coagulation tests. The infusion will be used intra-operatively.
16251948|NCT00994045|Biological|Fresh Frozen Plasma|
16251949|NCT00994032|Procedure|percutaneous injection of cement into the vertebral body|percutaneous injection of cement into the vertebral body
16251950|NCT00994032|Other|Medical treatment|standard antalgic medical treatment
16251951|NCT00994006|Dietary Supplement|Magnesium oxide|520 mg of elemental magnesium q.d.
16251952|NCT00994006|Dietary Supplement|Magnesium citrate|Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
16251953|NCT00993980|Procedure|qigong|one therapy session once a week during three months, that is 12 therapy sessions altogether
16251954|NCT00993980|Procedure|exercise therapy|one therapy session once a week during three months, that is 12 therapy sessions altogether
16251955|NCT00993967|Drug|idebenone|Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg
16251956|NCT00993954|Procedure|Reduction of Radial Head Subluxation|Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion
16251957|NCT00993941|Procedure|Autologous BMSCs transplantation|10 ml autologous BMSCs(7~8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.
16251958|NCT00993941|Drug|Conserved therapy|Oral or intravenous administration
16251959|NCT00993928|Behavioral|Home-based sleep intervention|Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
16251960|NCT00993915|Drug|Atorvastatin|Atorvastatin, 10- 80 mg, once daily, 6 month treatment
16251961|NCT00993902|Procedure|Intrauterine insemination (single)|Single IUI after 36-38 hours of HCG
16251962|NCT00993902|Procedure|Double intrauterine insemination|Double insemination after 18 and 40 hours of HCG administration.
16251963|NCT00993889|Behavioral|VR during Physical Therapy|Virtual Reality will be performed during a painful physical therapy procedure.
16251964|NCT00993889|Behavioral|VR Background Pain|Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.
16251965|NCT00993889|Behavioral|NO VR|The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.
16251966|NCT00993876|Drug|citalopram|20 to 30 mg per day for 4 weeks
16251967|NCT00993876|Drug|reboxetine|4 to 8 mg per day for 4 weeks
16251968|NCT00993876|Behavioral|interpersonal psychotherapy|
16251969|NCT00993863|Drug|Placebo|single dose
16251970|NCT00993863|Drug|ADL5859 30 mg|single dose
16251971|NCT00993863|Drug|ADL5859 100 mg|single dose
16251972|NCT00993863|Drug|ADL5859 200 mg|single dose
16251973|NCT00993863|Drug|ibuprofen 400 mg|single dose
16251974|NCT00993850|Behavioral|Cognitive behavioral therapy for insomnia|Attending 6-10 treatment sessions in one of our interview rooms. The sessions will be offered on a weekly basis. Each session takes approximately 50 minutes.
16251975|NCT00993850|Other|Bipolar education|Psychoeducation
16251976|NCT00993837|Procedure|thyroidectomy|total thyroidectomy via endoscopic approach and that convert to open procedure
16251977|NCT00993824|Drug|colesevelam HCl|3.75 grams of colesevelam HCl (6 tablets)
16251978|NCT00993824|Drug|placebo|
16251979|NCT00993811|Device|Shang Ring circumcision|novel device for adult male circumcision
16251980|NCT00993798|Drug|SABER-Bupivacaine Treatment 1a|5.0 ml
16251981|NCT00993798|Drug|Placebo SABER-Bupivacaine Treatment 1b|5.0 ml
16251982|NCT00993798|Drug|Bupivacaine HCl Treatment 1c|20.0 ml
16251983|NCT00993798|Drug|SABER-Bupivacaine Treatment 2a|7.5 ml
16251984|NCT00993798|Drug|Placebo SABER-Bupivacaine Treatment 2b|7.5 ml
16251985|NCT00993798|Drug|Bupivacaine HCl Treatment 2c|20.0 ml
16251986|NCT00993785|Device|Costar Coronary Stent Delivery System|
16251987|NCT00993759|Drug|3804-250A|3.2 ml applied topically after hand washing and at least every 3 hours while awake.
16251988|NCT00993746|Drug|Bupivacaine plus lidocaine|Bupivacaine 20 ml plus lidocaine 10 ml
16251989|NCT00993746|Drug|Bupivacaine 30 ml|Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block
16251990|NCT00993733|Procedure|Continuous veno-venous haemodiafiltration|Dialysis procedure administrated to the patients with acute renal failure
16251991|NCT00993720|Drug|Liraglutide|after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.
16251992|NCT00993720|Drug|Liraglutide|after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.
16251993|NCT00993720|Other|continuous insulin therapy|after optimal treatment with insulin, patients continue on insulin for four weeks
16251994|NCT00993707|Drug|CTX-100 (formerly ETX-100) (hyaluronic acid)|"3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.
~Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort."
16251995|NCT00993694|Drug|chemotherapy|
16251996|NCT00993694|Drug|dapsone|
16251997|NCT00993694|Other|medical chart review|
16251998|NCT00993694|Procedure|assessment of therapy complications|
16251999|NCT00993681|Biological|TD Vaccine System|heat labile enterotoxin of E. coli (LT)
16252000|NCT00993681|Biological|TD Vaccine System|placebo
16252001|NCT00993668|Other|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
16252002|NCT00993668|Biological|Certolizumab pegol|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
16252003|NCT00993655|Drug|carboplatin|Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
16252004|NCT00993655|Drug|cisplatin|Cisplatin 75 mg/m2 intraperitoneal day 1
16252005|NCT00993655|Drug|paclitaxel|Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
16252006|NCT00993642|Drug|Panobinostat (LBH589)|Patients will be given five 30mg doses of HDAC inhibitor (LBH) over a period of two weeks. A dose will be taken on Days 1,3,5,8 and 10. Patients will have a diagnostic tumor biopsy prior to drug administration and a diagnostic biopsy within 48 hours (2 days) of the last dose.
16252007|NCT00993629|Drug|pregnenolone|"Administered adjunctively to treatment as usual"
16252008|NCT00993629|Drug|placebo|adjunctive placebo
16252009|NCT00993616|Drug|belinostat|Given IV
16252010|NCT00993616|Drug|carboplatin|Given IV
16252011|NCT00993603|Behavioral|8-month group lifestyle programme|Dietary and lifestyle counselling (11 sessions), weekly exercise programme and 3 fasting blood samples at baseline, 4 and 8 months.
16252012|NCT00993590|Behavioral|M CHESS|Smartphone with access to MCHESS, an asthma control system that provides easy-to-access, just-in-time information and support.
16252013|NCT00993577|Other|Stretching exercises|Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
16252014|NCT00993577|Device|Stretching exercises|Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
16252015|NCT00993577|Device|Exercises|Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
16252016|NCT00993551|Procedure|primary surgery for cleft palate|Surgery completed using the Sommerlad technique
16252017|NCT00993538|Procedure|Blood sampling|
16252018|NCT00993538|Procedure|Bone marrow aspiration|
16252019|NCT00993525|Drug|Intravitreal injection of ranibizumab|0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography
16252020|NCT00993512|Drug|Amphinex (TPCS2a)|intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
16252021|NCT00993512|Drug|Bleomycin|intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
16252022|NCT00993512|Other|Illumination with CeramOptec laser|intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
16252023|NCT00993499|Drug|BIBW 2992|Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs
16252024|NCT00993499|Drug|Sirolimus (rapamycin)|Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.
16252025|NCT00993486|Biological|Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)|Single intravenous infusion
16252026|NCT00993473|Drug|Insulin glargine (HOE901)|"100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U
~Dose: titrated to achieve the following glycemic targets without hypoglycemia:
~Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0 mmol/L), inclusive,
~Bedtime BG between 120 and 180 mg/dL (6.7 to10.0 mmol/L), inclusive,
~Nocturnal BG between 80 and 162 mg/dL (4.4 to 9.0 mmol/L), inclusive; and
~HbA1c <7.5%."
16252027|NCT00993473|Drug|Neutral Protamine Hagedorn (NPH) insulin|"NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U
~Dose: titrated to achieve glycemic targets as described above for insulin glargine"
16252028|NCT00993473|Drug|Insulin lispro|Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator.
16252029|NCT00993447|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous at Day 0, 6 and 12 months
16252030|NCT00993447|Biological|Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis|NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months
16252031|NCT00993434|Behavioral|Booklet on nutrition and physical activity.|Parents will be asked to read the booklet and complete a pre- and post-questionnaire.
16252032|NCT00993434|Behavioral|Safety Booklet|Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.
16252033|NCT00993421|Drug|LY377604|Given daily, orally for 24 weeks
16252034|NCT00993421|Drug|Sibutramine|given daily, orally for 24 weeks
16252035|NCT00993421|Drug|Metoprolol|given daily, orally for 24 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).
16252036|NCT00993421|Drug|Placebo sibutramine|given daily, orally for 24 weeks
16252037|NCT00993421|Drug|Placebo Metoprolol|given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
16252038|NCT00993421|Drug|Placebo LY377604|given daily, orally for 24 weeks
16252039|NCT00993408|Device|ACT-293987 (NS-304)|
16252040|NCT00993395|Behavioral|peer mentor-based disease management|peer mentor-based disease management focused on three domains: medical care, recovery, and social stabilization
16252041|NCT00993382|Drug|Celivarone|"Pharmaceutical form: capsule
~Route of administration: oral"
16252042|NCT00993382|Drug|Amiodarone|"Pharmaceutical form: capsule
~Route of administration: oral"
16252043|NCT00993382|Drug|Matching placebo|"Pharmaceutical form: capsule
~Route of administration: oral
~Matching placebo added to active drug if any for a total of 3 capsules per intake"
16252044|NCT00993369|Other|Holter monitor|Record heart rate for 2 to 6 hours on day of life 1 or 2.
16252045|NCT00993356|Drug|Preoperative lanreotide treatment|Patients received lanreotide for 16 weeks before the surgical resection [starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH > 5 mU/L on GH day curve (GHDC)] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).
16252046|NCT00993356|Procedure|Transsphenoidal surgery|
16252047|NCT00993343|Drug|Sirolimus/tacrolimus|Standard GVHD prophylaxis
16252048|NCT00993343|Drug|cyclosporine/methotrexate|Standard GVHD prophylaxis
16252049|NCT00993317|Drug|Placebo of CDP870|Given every 2 weeks until Week22 (SC)
16252050|NCT00993317|Drug|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)
16252051|NCT00993317|Drug|Methotrexate|"Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.
~The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly."
16252052|NCT00993304|Drug|liraglutide|In the first 3-week period, the treatment will be one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg liraglutide. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of 3 weeks' treatment with placebo. At the end of each of the 2 treatment periods, a high fat meal test will be performed.
16252053|NCT00993304|Drug|placebo|In the first 3-week period, the treatment will be with placebo. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg of liraglutide. At the end of each of the 2 treatment periods, a high fat meal test will be performed.
16252054|NCT00993291|Procedure|Frequency change to 60 Hz|60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
16252055|NCT00993291|Procedure|Frequency change to 130 Hz|130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
16252056|NCT00993278|Dietary Supplement|Low-Carbohydrate (Modified Atkins) Diet|Low-Carbohydrate (Modified Atkins) Diet
16252057|NCT00993278|Dietary Supplement|Low-Fat (Heart Healthy) Diet|Low-Fat (Heart Healthy) Diet
16252058|NCT00993265|Drug|N-Acetylcysteine|2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
16252059|NCT00993265|Drug|Placebo|placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
16252060|NCT00993252|Procedure|CT Scan|CT scan
16252061|NCT00993239|Drug|Birinapant (TL32711)|30 minute intravenous (IV) infusion administered once weekly for three consecutive weeks followed by a one week off (Cycle) repeated every 4 weeks as tolerated
16252062|NCT00993226|Drug|SABER-Bupivacaine Treatment 1a|5.0 ml
16252063|NCT00993226|Drug|Placebo SABER-Bupivacaine Treatment 1b|5.0 ml
16252064|NCT00993226|Drug|Bupivacaine HCl Treatment 1c|40 ml
16252065|NCT00993226|Drug|SABER-Bupivacaine Treatment 2a|7.5 ml
16252066|NCT00993226|Drug|Placebo SABER-Bupivacaine Treatment 2b|7.5 ml
16252067|NCT00993226|Drug|Bupivacaine HCl Treatment 2c|40 ml
16254988|NCT00973271|Drug|435 mg DCCR|435 mg diazoxide choline
16252068|NCT00993213|Procedure|Standard of Care with Liposuction|Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.
16252069|NCT00993213|Other|Standard of Care without Liposuction|Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.
16252070|NCT00993200|Genetic|warfarin pharmacogenetic dosing|Warfarin pharmacogenetic dosing incorporated into a validated clinical algorithm displayed in a computer (PERMIT) management interface
16252071|NCT00993200|Drug|Warfarin|Usual care warfarin dosing
16252072|NCT00993187|Drug|Sitagliptin/Metformin FDC|Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks
16252073|NCT00993187|Drug|Comparator: Glimepiride|Glimepiride tablet orally up to 6 mg daily for 30 Weeks
16252074|NCT00993187|Drug|Matching placebo to Sitagliptin/Metformin FDC|Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks
16252075|NCT00993187|Drug|Matching placebo to glimepiride|Matching placebo to glimepiride tablet orally daily for 30 weeks
16252076|NCT00993174|Procedure|Topical strabismus surgery|Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
16252077|NCT00993174|Procedure|Sub-Tenon's strabismus surgery|Surgery is carried out after sub-Tenon's injection of xylocaine
16252078|NCT00993161|Device|Motriplate|Number of contact couples
16252079|NCT00993161|Device|Motriplate|Number of contact couples
16252080|NCT00993148|Drug|maraviroc|150 mg tab by mouth once daily for 96 weeks
16252081|NCT00993148|Drug|darunavir|800 mg tab by mouth once daily for 96 weeks
16252082|NCT00993148|Drug|ritonavir|100 mg capsule by mouth once daily for 96 weeks
16252083|NCT00993135|Drug|methotrexate|
16252084|NCT00993135|Other|medical chart review|
16252085|NCT00993135|Procedure|assessment of therapy complications|
16252086|NCT00993122|Drug|ribavirin pre-treatment|patients receive ribavirin (10,4 mg/kg/day) and pegylated interferon alfa-2b (1,5 mcg/kg/week).Pre-treatment arm will receive a 8-week monotherapy treatment with only ribavirin (same dosage) and the controlled arm will receive 48 week of standard combined therapy (ribavirin plus pegylated interferon)
16252087|NCT00993109|Drug|Adalat (Nifedipine, BAYA1040)|Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
16252088|NCT00993109|Drug|Diovan (Valsartan)|Valsartan 160 mg OM (Two Valsartan 80mg tablets)
16252089|NCT00993096|Drug|insulin degludec/insulin aspart|Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
16252090|NCT00993096|Drug|insulin degludec/insulin aspart|Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
16252091|NCT00993096|Drug|insulin degludec/insulin aspart|Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
16252092|NCT00993096|Drug|biphasic insulin aspart 30|Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
16252093|NCT00993096|Drug|biphasic insulin aspart 30|Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
16252094|NCT00993096|Drug|biphasic insulin aspart 30|Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
16252095|NCT00993083|Biological|MVA-NP+M1|Intramuscular injection at 1.5 x 10^8 pfu/ml at day 0
16252096|NCT00993070|Drug|Capsaicin|0.025% topical capsaicin applied 4 times per day for 8 weeks
16252097|NCT00993070|Drug|placebo|vehicle gel, applied 4 times per day for 8 weeks
16252098|NCT00993057|Drug|Insulin|Adjustable insulin infusion scale with loading doses
16252099|NCT00993044|Drug|Irinotecan|"Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed on dose level 2"
16252100|NCT00993044|Drug|Vincristine|"Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed on dose level 2"
16252101|NCT00993044|Drug|Temozolomide|"Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed on dose level 2"
16252132|NCT00992836|Biological|Influenza A (H1N1) 2009 monovalent vaccine|Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
16252133|NCT00992823|Drug|iron supplementation|40 doses of 30 mg of ferrous sulfate during a 10-month intervention period
16252134|NCT00992823|Biological|iron supplementation|supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
16252102|NCT00993044|Drug|Bevacizumab|"Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1
~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed on dose level 2"
16252103|NCT00993031|Drug|Lopinavir/ritonavir|LPV 200mg/r 50mg
16252104|NCT00993031|Drug|Efavirenz|600mg
16252105|NCT00993031|Drug|Zidovudine|Zidovudine 300 mg
16252106|NCT00993031|Drug|Lamivudine|Lamivudine 150 mg
16252107|NCT00993018|Drug|JNJ-42160443 (1 mg)|JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
16252108|NCT00993018|Drug|JNJ-42160443 (3 mg)|JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
16252109|NCT00993018|Drug|JNJ-42160443 (10 mg)|JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
16252110|NCT00993018|Drug|Placebo|Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.
16252111|NCT00993005|Other|Cicatrix|Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.
16252112|NCT00993005|Other|Placebo|Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
16252113|NCT00992992|Biological|Tositumomab and Iodine I 131 Tositumomab followed by CHOP|Patients will receive an infusion of unlabeled Tositumomab (450 mg) followed by an infusion of Tositumomab (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Tositumomab (450 mg) followed by an infusion of 35 mg Tositumomab containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,000-149,000 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose. Approximately 13 weeks following the therapeutic dose, CHOP will be administered every 21 days for a total of 6 cycles.
16252114|NCT00992979|Procedure|Therapeutic Massage|Massage therapists with at least 5 years experience will perform the massages. On each of three consecutive days, participants (while fully clothed and in a seated position) will receive a 20-minute back, shoulder, neck and head massage. Subjects will be treated with conventional light pressure Swedish massage techniques which consisted of continuous systematic strokes including kneading and stretching to loosen and rehabilitate the soft tissues of the body and to provide general relaxation. The manual techniques include: effleurage , soothing petrissage , repetitive stroking, rocking , squeezing and mild joint mobilization. As is standard practice in massage therapy delivery, room lights will be dimmed and soft, soothing music played to enhance relaxation during therapy.
16252115|NCT00992979|Procedure|Relaxation Control|On each of three consecutive evenings, subjects in this group will participate in a 20 minute relaxation session. This session will be delivered in the same location and with the same lighting and music as with the therapeutic massage group. Each participant will be asked to choose a comfortable position in a chair and a massage therapist will sit quietly in the room approximately 4 feet behind the participant.
16252116|NCT00992953|Behavioral|Treatment as Usual|10 weeks of therapy and/or psychiatric medication as available
16252117|NCT00992953|Behavioral|Virtual Reality Exposure with Stimulus Control|10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control
16252118|NCT00992940|Procedure|Patient-Controlled Sedation/Analgesia|Patient controls delivery of sedation and analgesia requirements.
16252119|NCT00992940|Procedure|Anesthetist-Controlled Sedation/Analgesia|All sedation and analgesia requirements are determined and delivered by the attending anesthetist.
16252120|NCT00992927|Procedure|Capsule-Preserving Intra-articular Hydraulic Distension|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
16252121|NCT00992927|Procedure|Capsule-Rupturing Intra-articular Hydraulic Distension|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
16252122|NCT00992914|Procedure|Sympathetic nerve block with 1% lidocaine 1-2 ml|Stellate Ganglion Injection
16252123|NCT00992914|Procedure|Superficial subcutaneous injection|Superficial subcutaneous injection with saline
16252124|NCT00992901|Drug|Exendin-(9-39)|A physiological study to evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
16252125|NCT00992901|Drug|Atropine|A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism
16252126|NCT00992901|Drug|GLP-1 and GIP|A physiological study to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
16252127|NCT00992888|Device|Prometheus Liver Dialysis system (Fresenius Medical Care)|6 hour dialysis for 3 consecutive days
16252128|NCT00992875|Behavioral|Mindfulness-Based Stress Reduction|Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities
16252129|NCT00992862|Drug|Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.|
16252130|NCT00992862|Drug|Univasc® 15mg Tablets|
16252131|NCT00992849|Drug|Bevacizumab|Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc
16252135|NCT00992810|Procedure|Lateral-to-Medial Approach|Approach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction.
16252136|NCT00992810|Procedure|Media-to-Lateral Approach|Approach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction.
16252137|NCT00992797|Drug|Cholecalciferol|Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice.
16252138|NCT00992797|Other|Orange juice|Orange juice at randomization day and at week 5.
16252139|NCT00992784|Biological|GSK investigational vaccine 2186877A|Single dose, intramuscular injection
16252140|NCT00992784|Biological|FluarixTM|Single dose, intramuscular injection
16252141|NCT00992771|Drug|varenicline|up to 1mg BID for 8 weeks
16252142|NCT00992771|Drug|placebo|placebo matching varenicline, up to 1mg BID for 8 weeks
16252143|NCT00992758|Biological|Iodine-131 Anti-B1 Antibody|"Dosimetric Dose: 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes.
~Therapeutic Dose: 7-14 days after dosimetric dose, 450 mg Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached."
16252144|NCT00992745|Drug|123-I-MIP-1072|Single 10 mCi intravenous injection
16252145|NCT00992745|Drug|111-In capromab pendetide|Single 5 mCi intravenous injection
16252146|NCT00992745|Drug|123-I-MIP-1072|Single 5 mCi intravenous injection
16252147|NCT00992732|Drug|HQK-1004|1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
16252148|NCT00992732|Drug|Valganciclovir (may substitute with ganciclovir)|900 mg BID oral for 21 days (Days 1-21 of each 21 day cycle). If the subject cannot tolerate or absorb valganciclovir, ganciclovir my be administered instead at 5 mg/kg intravenously BID until the subject can tolerate and absorb valganciclovir.
16252149|NCT00992719|Biological|Inactivated H1N1 Vaccine|H1N1 vaccine [Influenza A (H1N1) 2009 Monovalent Vaccine] is a licensed, inactivated influenza virus vaccine. It will be provided as prefilled single dose syringes containing 0.5 mL. The 0.5 mL prefilled syringe is formulated without preservative. The 15 microgram (mcg) dose will be administered as a single 0.5 mL intramuscular (IM) injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as two 0.5 mL injections in the deltoid muscle of each arm.
16252150|NCT00992706|Drug|antiperspirant cream F511|Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.
16252151|NCT00992706|Drug|pegylated liposomal doxorubicin hydrochloride|According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.
16252152|NCT00992693|Drug|Ribavirin (Virazole) Injection|"The drug is to be administered in a volume of 50-100 ml of normal saline to be infused over 30-40 minutes.
~1) Loading dose: 33 mg/kg (maximum dose 2.64 g)(1 dose) 2) Followed by a dose of 16 mg/kg (max dose 1.28 g) every 6 hours for the first 4 days (15 doses) 3) Followed by a dose of 8 mg/kg (maximum dose 0.64 g) every 8 hours for the subsequent 6 days (18 doses) Ten day course of treatment with follow up between day 28 to day 60."
16252153|NCT00992680|Device|ROX Anastomotic Coupler System (ACS)|The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
16252154|NCT00992667|Drug|Apocynin nebulization|6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.)
16252155|NCT00992654|Drug|Open Label Treatment Access: Maraviroc|Oral dosing twice daily. The dose will depend on the optimized background therapy.
16252156|NCT00992641|Other|Experimental diet|Diet based on Nordic recommendations: rich in whole grain products, berries, fruits and vegetables, recommended fat quality. Realised based on eating habits of each Nordic country.
16252157|NCT00992641|Other|Control diet|Diet based on the information of the current dietary intake and food consumption in Nordic countries.
16252158|NCT00992628|Device|Macintosh (direct vision) laryngoscope|Macintosh (direct vision) laryngoscope
16252159|NCT00992628|Device|GlideScope videolaryngoscope (indirect vision)|GlideScope videolaryngoscope (indirect vision)
16252160|NCT00992615|Procedure|prostate biopsy|prostate cores - 12 or 20
16252161|NCT00992602|Drug|methotrexate|Given IV
16252162|NCT00992602|Drug|liposomal cytarabine|Given IT or via LP
16252163|NCT00992602|Other|quality-of-life assessment|Ancillary studies
16252164|NCT00992602|Other|laboratory biomarker analysis|Correlative studies
16252165|NCT00992589|Drug|Rabeprazole sodium 5 mg|Rabeprazole Sodium 5 mg capsules once daily in the morning.
16252166|NCT00992589|Drug|Rabeprazole sodium 10 mg|Rabeprazole Sodium 10 mg capsules once daily in the morning.
16252167|NCT00992589|Drug|Placebo|Matching placebo capsules once daily in the morning.
16252168|NCT00992576|Drug|Active Hydromorphone PR + Active Naloxone PR|Optimal pain relief and improved bowel function in constipated pain patients
16252169|NCT00992576|Drug|Active Hydromorphone PR + Placebo Naloxone PR|Optimal pain relief and improved bowel function in constipated pain patients
16252170|NCT00992563|Drug|AL-39324 ophthalmic suspension|
16252171|NCT00992563|Drug|Ranibizumab 10 mg/mL|
16252172|NCT00992550|Drug|Cigarette|
16252173|NCT00992550|Drug|Hookah|
16252174|NCT00992537|Drug|insulin degludec|Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
16252175|NCT00992537|Drug|insulin degludec/insulin aspart|Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
16252176|NCT00992537|Drug|insulin aspart|Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
16252259|NCT00991952|Other|laboratory biomarker analysis|Correlative studies
16252421|NCT00990808|Drug|Comparator: atorvastatin|Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
16252177|NCT00992524|Drug|Misoprostol|Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours.
16252178|NCT00992524|Drug|Misoprostol|Vaginal tablets will have 25mcg of misoprostol or placebo.
16252179|NCT00992511|Biological|GSK investigational vaccine GSK2340272A|One intramuscular injection of initial process-manufactured GSK2340272A vaccine
16252180|NCT00992511|Biological|GSK investigational vaccine GSK2340272A|Two intramuscular injections of initial process-manufactured GSK2340272A vaccine
16252181|NCT00992511|Biological|GSK investigational vaccine GSK2340272A|One intramuscular injection of new process-manufactured GSK2340272A vaccine
16252182|NCT00992511|Biological|GSK investigational vaccine GSK2340272A|Two intramuscular injections of new process-manufactured GSK2340272A vaccine
16252183|NCT00992485|Drug|ADIPOPLUS|autologous adipose-derived stem cell
16252186|NCT00992459|Drug|HPN-100|HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4mL) delivers equivalent amount of PBA in 40 tablets of NaPBA.
16252187|NCT00992459|Drug|Buphenyl (NaPBA)|Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.
16252188|NCT00992446|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
16252189|NCT00992446|Drug|Bortezomib|Given IV
16252190|NCT00992446|Drug|Carmustine|Given IV
16252191|NCT00992446|Drug|Cytarabine|Given IV
16252192|NCT00992446|Drug|Etoposide|Given IV
16252193|NCT00992446|Drug|Melphalan|Given IV
16252194|NCT00992446|Drug|Rituximab|Given IV
16252195|NCT00992446|Drug|Vorinostat|Given PO
16252196|NCT00992433|Biological|Inactivated Influenza H1N1 vaccine|Two doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.
16252197|NCT00992407|Drug|Risperidone long acting injectables|Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.
16252198|NCT00992407|Drug|Risperidone tablets|Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.
16252199|NCT00992394|Drug|etanercept|etanercept 50 mg once weekly as requested.
16252200|NCT00992394|Drug|etanercept|etanercept 25 mg or 50 mg as requested.
16252201|NCT00992381|Drug|PN400|500mg Naproxen and 20mg esomeprazole
16252202|NCT00992381|Drug|Naprosyn|500mg Naproxen
16252203|NCT00992368|Procedure|reduction mammaplasty|patients submitted to reduction mammaplasty
16252204|NCT00992355|Drug|Tobramycin 0.3% - Dexamethasone 0.1%|
16252205|NCT00992355|Drug|Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%|
16252206|NCT00992342|Drug|PF-03893787|oral solution, 5 mg, QD for 14 days
16252207|NCT00992342|Drug|PF-03893787|oral solution, 15 mg, QD for 14 days
16252208|NCT00992342|Drug|PF-03893787|oral solution, 50 mg, QD for 14 days
16252209|NCT00992329|Drug|ciprofloxacin|ciprofloxacin 200mg tablet (single dose)
16252210|NCT00992316|Drug|PF-04531083|solution. doses to be selected based upon safety/tolerability/PK at preceeding dose
16252211|NCT00992303|Other|biologic sample preservation procedure|
16252212|NCT00992303|Other|medical chart review|
16252213|NCT00992303|Other|questionnaire administration|
16252214|NCT00992290|Biological|Lactobacillus GG|1 capsule of lactobacillus GG BID compared to placebo BID
16252215|NCT00992290|Biological|Placebo|1 capsule of lactobacillus GG BID compared to placebo BID
16252216|NCT00992277|Procedure|Ablation and skin resurfacing|
16252217|NCT00992264|Behavioral|Message Tone|All participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone.
16252218|NCT00992264|Behavioral|Navigation|Persons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website.
16252219|NCT00992264|Behavioral|Proactive Outreach|Persons receive periodic, proactively delivered email reminders to visit the intervention website.
16252220|NCT00992264|Behavioral|Testimonials|People receive a personally-tailored testimonial as part of their online smoking cessation program.
16252223|NCT00992225|Drug|LY573636-sodium|Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met
16252224|NCT00992212|Biological|Monovalent A/H1N1 influenza vaccine|This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
16252225|NCT00992199|Drug|cisplatin, Fluorouracil|cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
16252226|NCT00992186|Drug|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
16252260|NCT00991939|Drug|Dexamethasone USP Micronized|The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
16252422|NCT00990808|Drug|Comparator: placebo to MK0859|Placebo to MK0859 once daily for 4 weeks.
16252495|NCT00990132|Device|Home mechanical ventilation|Nocturnal non-invasive ventilation
16252227|NCT00992173|Drug|Ultratrace Iobenguane I 131|Subjects will receive an Imaging Dose of 0.1 mCi/kg [3.7 MBq/kg] (a minimum dose of 1.0 mCi [37 MBq] but not to exceed 5.0 mCi [185 MBq]) of Ultratrace iobenguane I 131 to have dosimetry performed and to confirm tumor uptake of the test article prior to receiving each of 2 planned Therapeutic Doses of Ultratrace iobeneguane I 131 . Within 28 days of screening, eligible subjects (as confirmed by the first Imaging dose study)will receive an Ultratrace iobenguane I 131 Therapeutic dose of of 15.0 - 18.0 mCi/kg (max. 666 MBq/kg) followed by imaging 7 days later or upon discharge from radiation isolation. A second Therapeutic Dose (preceded by a repeat Image Dose and dosimetry study)and imaging upon discharge from radiation isolation will be repeated approximately 8 weeks after the first dose.
16252228|NCT00992160|Drug|GW597599|GW597599 15mg tablet
16252229|NCT00992160|Drug|Placebo|Placebo to match GW597599 15mg tablet
16252230|NCT00992147|Drug|Adipocell|autologous cultured adipocytes (ANTG-adip)
16252231|NCT00992134|Drug|Rituximab, Bendamustine, Cytarabine|"Rituximab IV 375 mg/m2 on day 1. Bendamustine IV 70 mg/m2 over a 30-60 minute infusion on day 1 and 2. Cytarabine IV 800 mg/m2, over a 2-hour infusion, 2 hours after Bendamustine, on Day 1, 2, and 3.
~Four to six cycles. Recycle every 28 days."
16252232|NCT00992121|Drug|Bevacizumab|Bevacizumab - 3 infusions of 10mg/kg administered at 2 week intervals - Part I
16252233|NCT00992121|Drug|Pazopanib 2 week|"Pazopanib for first 2 weeks of each 3-week cycles as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1).
~Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons."
16252234|NCT00992121|Drug|Pazopanib 3 week|"Pazopanib throughout each 3-week cycle as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1).
~Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons."
16252235|NCT00992108|Drug|lidocaine|1cc 1%
16252236|NCT00992108|Drug|chemodenervation|botulinum toxin
16252237|NCT00992095|Drug|buprenorphine hydrochloride|single dose 8 mg sublingual tablet
16252238|NCT00992082|Drug|ropivacaine, ketorolac and epinephrine|Spinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
16252239|NCT00992082|Drug|morphine|Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.
16252240|NCT00992069|Drug|Efavirenz (EFV)|Oral dose of 600 mg daily, taken in the evening
16252241|NCT00992069|Drug|TMC207|Single oral dose of 400 mg in the morning
16252242|NCT00992056|Drug|nebivolol|5 mg titrated to 10 mg daily versus matching placebo
16252243|NCT00992056|Drug|Metoprolol|Metoprolol 50 mg titrated to 100 mg
16252244|NCT00992043|Dietary Supplement|creatine|
16252245|NCT00992043|Other|Exercise training|
16252246|NCT00992030|Drug|Rituximab|I.V. infusion weekly x 6 weeks at a dose of 375 mg/m2
16252247|NCT00992030|Radiation|Involved field irradiation|Radiation therapy, limited to initially involved nodal sites, will start within four weeks from the last cycle of ABVD chemotherapy and after complete restaging with TAC total-body and PET total-body. The planned total dose is 30,6 Gy.
16252248|NCT00992017|Biological|Influenza A (H1N1) monovalent vaccine|Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart
16252249|NCT00992004|Dietary Supplement|Arantal® (highly bioavailable turmeric extract)|4 capsules a day, before breakfast
16252250|NCT00991991|Genetic|gene expression analysis|Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
16252251|NCT00991991|Genetic|polymerase chain reaction|Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
16252252|NCT00991991|Genetic|polymorphism analysis|Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
16252253|NCT00991991|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
16252254|NCT00991991|Other|medical chart review|Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases.
16252255|NCT00991978|Other|89Zr-bevacizumab PET|PET-scan with 89Zr-bevacizumab
16252256|NCT00991965|Device|INFUSE® Bone Graft|Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS in the area of the dental implant on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments 6 months after surgery for placement of the appropriate prosthetic, and assessment of osseointegration and stability. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.
16252257|NCT00991952|Drug|alvocidib|Given IV
16252258|NCT00991952|Drug|irinotecan hydrochloride|Given IV
16252261|NCT00991939|Drug|Prednisone|Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
16252262|NCT00991926|Drug|Orlistat|orlistat (Xenical, Roche, UK)120 mg tid
16252263|NCT00991926|Other|normo-caloric diet|Food intake and dietary history were assessed by a skilled dietitian who used a computer-assisted interview (Winfood 1.5, Medimatica srl, Martinsicuro, Italy)
16252264|NCT00991900|Device|Measurement of oxygen saturation of retinal vessels with optical reflectometer|5 repeated measurements on both study days
16252265|NCT00991887|Radiation|Radiation Therapy (XRT)|The dose will be 700 gray (derived unit of ionizing radiation dose in the International System of Units) in a single fraction, using AP-PA fields calculated to midplane. No Less than 6 MV energy photons will be used, and no bolus is placed on the skin. The field covers the entire joint, the antecubital fossa and the olecranon process. A strip of skin at the antecubital area is generally shielded, but is not an absolute requirement for this study.
16252266|NCT00991861|Drug|LAS41007 o.d.|Once daily, topical application
16252267|NCT00991861|Drug|LAS41007 b.i.d.|Twice daily, topical application
16252268|NCT00991861|Drug|LAS106521|Twice daily, topical application
16252269|NCT00991848|Drug|Lidocaine|received 240 mg lidocaine diluted in 125 mL 0.9% saline.
16252270|NCT00991822|Drug|Dorzolamide 2%|
16252271|NCT00991822|Drug|Timolol 0.5%|
16252272|NCT00991809|Drug|Alfentanil|15 mcg/kg IM
16252273|NCT00991809|Drug|Diphenhydramine|25 mg IM
16252274|NCT00991796|Drug|CS-1008|CS-1008 powder for concentrate for solution for infusion. six cycles of combination therapy with 3 weeks equal to one cycle. 10 mg/kg
16252275|NCT00991796|Drug|Placebo|Placebo
16252276|NCT00991796|Drug|Paclitaxel|Paclitaxel concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 175 mg/m2
16252277|NCT00991796|Drug|Carboplatin|Carboplatin concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 6 mg/m2
16252278|NCT00991783|Drug|Digoxin + Fimasartan|Digoxin (7 days), Digoxin + Fimasartan (7 days)
16252279|NCT00991770|Other|Massage Therapy|Two 20 minute chair massages: one before surgery and one after
16252280|NCT00991770|Other|Attention Control|Two 20 minute sessions where the Massage Therapist will talk to the patient about how they are feeling, listen, and provide empathetic support.
16252281|NCT00991757|Drug|carisbamate|Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).
16252282|NCT00991744|Drug|Liposomal cytarabine|Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
16252283|NCT00991744|Drug|Intrathecal triple|Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol
16252284|NCT00991731|Behavioral|Faith-based|The faith-based intervention will include 24 group sessions. Sessions 1 - 16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur monthly. Sessions will be scheduled to last for 90 minutes each. This will include a 30-minute physical activity session (led by a trained exercise leader) and 60 minutes of group discussion (led by a Community Health Worker trained in group facilitation, familiarity with theology and health ministry education, and experience implementing group-based activities in faith settings). Group discussion content will be standardized to ensure consistent delivery. All items will be delivered with biblical references to further guide the participants.
16252285|NCT00991731|Behavioral|Non-faith-based|The non-faith based intervention will include 24 group sessions. Sessions 1 - 16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur monthly. Sessions will be scheduled to last for 90 minutes each. This will include a 30-minute physical activity session (led by a trained exercise leader) and 60 minutes of group discussion (led by a Community Health Worker trained in group facilitation, familiarity with theology and health ministry education, and experience implementing group-based activities in faith settings). Group discussion content will be standardized to ensure consistent delivery. All items will be delivered without biblical references as in the faith-based intervention.
16252286|NCT00991718|Drug|GDC-0449 oral capsules (non-labeled)|150 mg oral capsule
16252287|NCT00991718|Drug|GDC-0449 IV injection (labeled)|10 mcg (in 2 mL) IV dose of 14C-GDC-0449
16252288|NCT00991718|Drug|CDC-0449 oral suspension (labeled)|30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449
16252289|NCT00991705|Drug|Atorvastatin|
16252290|NCT00991705|Drug|Fimasartan|
16252291|NCT00991692|Other|Therapy services (ACQUIREc Therapy)|Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
16252292|NCT00991666|Procedure|blood flow measurement|Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement
16252293|NCT00991653|Procedure|Fasting blood sample.|Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.
16252294|NCT00991640|Behavioral|2-day preceptorship on obesity management|
16252295|NCT00991627|Drug|Bupivacaine|10 mg of a 5 mg/ml hyperbaric solution, intrathecally
16252296|NCT00991627|Drug|Morphine|200 µg of a 100 µg/ml solution, intrathecally
16252297|NCT00991627|Drug|Lactated Ringer's solution|25 ml/min intravenously
16252298|NCT00991627|Drug|Ephedrine, continuous infusion|37.5 mg/h intravenously
16252299|NCT00991627|Drug|Ephedrine, bolus|"6.25 mg IV bolus prn.
~Hypotension defined according to study protocol for each arm."
16252300|NCT00991627|Drug|Atropine|"0.1 mg/kg iv bolus prn
~Bradycardia defined as 50% drop in heart rate from baseline values."
16252301|NCT00991614|Device|EVOLUTION® Duodenal Stent|EVOLUTION® Duodenal Stent
16252302|NCT00991601|Procedure|FNAC (fine needle aspiration cytology)|UL guided biopsy
16252418|NCT00990821|Drug|125 mg Aprepitant|Aprepitant oral tablet, single dose
16252419|NCT00990821|Drug|2 mg Midazolam|Midazolam oral tablet, single dose
16252303|NCT00991588|Procedure|PCL, posterolateral reconstruction|The operative procedures involve either a single- or double-strand PCL graft which is usually harvested from the patient's knee. In cases of multiple ligament procedures, allograft tissues may be used which are obtained from tissue banks certified by the American Associate of Tissue Banks and that have passed FDA inspection. The posterolateral structures, including the fibular collateral ligament (FCL), are reconstructed with one or two grafts, depending upon the severity of damage encountered at surgery.
16252304|NCT00991562|Drug|IMGN901|dose escalation study. dosing on days 1, 8 and 15 every 28 days
16252305|NCT00991549|Behavioral|interdisciplinary intervention or meeting-seminars|one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
16252306|NCT00991523|Dietary Supplement|protein|protein
16252307|NCT00991523|Dietary Supplement|placebo|placebo control
16252308|NCT00991510|Drug|mycophenolate mofetil (Myfenax)|Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.
16252309|NCT00991510|Drug|mycophenolate mofetil (Cellcept)|Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.
16252310|NCT00991497|Device|Compression bandaging|Cotton wool padding will then be placed over the treated vein and secured in place by crepe bandaging. An above-knee TED stocking will be applied on top of this.
16252311|NCT00991471|Behavioral|Interaction with MDRN STAT|Interaction with MDRNSTAT at triage to obtain orders for investigations and/or treatment
16252312|NCT00991471|Behavioral|No MDRNSTAT|Standard management of nurse-only triage for assignment of CTAS
16252313|NCT00991458|Drug|Cyclosporine 0.010% eye drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
16252314|NCT00991458|Drug|Cyclosporine 0.005% eye drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
16252315|NCT00991458|Drug|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
16252316|NCT00991445|Procedure|Minimal Invasive Surgery|After a 8-10 cm skin incision, a medial parapatellar capsule incision is made. The vastus medialis muscle or the rectus tendon are not incised, nor is the patella everted. The patella is merely pushed slightly aside when the bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.
16252317|NCT00991445|Procedure|Conventional exposure|After a 15-20 cm midline skin incision is made, a medial parapatellar capsule incision is made. The incision is carried up through the insertion of the vastus medialis and into the rectus tendon. The patella is everted. The bone cuts are made and the prostheses are cemented in place. Local Infiltration Analgesia is used.
16252318|NCT00991432|Device|INFUSE® Bone Graft|Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS concurrent with space maintenance devices for soft tissue management on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments approximately 6 months after surgery. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.
16252319|NCT00991419|Drug|[18F]AZD4694|[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.
16252320|NCT00991406|Device|FES|Surface stimulation to contract the muscles in the lower extremity
16252321|NCT00991393|Device|INFUSE® Bone Graft|Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS in the area of the dental implant on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments 6 months after surgery for placement of the appropriate prosthetic, and assessment of osseointegration and stability. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.
16252322|NCT00991380|Behavioral|HEALD|A six month, two phase pedometer-based walking program. For weeks one and two of phase I, participants will attend a group-based 60 minute education/supervised walking session. They will be asked to set a daily step goal and to attempt to achieve this on a daily basis over three months. Their steps will be recorded in a step log. For weeks one and two of phase II, participants will learn how to increase the speed of a portion of their daily steps and will learn the concept of low glycemic index and how to set dietary goals related to this concept. They will attend two sixty minute group-based education/supervised walking sessions.
16252323|NCT00991380|Behavioral|Usual Care|Control
16252324|NCT00991367|Other|Cicatrix|Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
16252325|NCT00991367|Other|Placebo|Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
16252326|NCT00991354|Biological|PENNVAX-B|DNA vaccine encoding the Gag, Pol, and Env proteins of HIV
16252327|NCT00991354|Biological|IL-12 DNA plasmids|Adjuvant for HIV vaccines
16252328|NCT00991341|Biological|Red blood cell units stored <= 10 days|Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
16252329|NCT00991341|Biological|Red blood cell units stored >= 21 days|Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
16252420|NCT00990808|Drug|anacetrapib|[Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
16252330|NCT00991328|Procedure|SctO2 < 60 %.|The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.
16252331|NCT00991302|Behavioral|CAP-IT|Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
16252332|NCT00991289|Drug|Nitazoxanide (NTZ)|500 mg twice daily, taken orally with food
16252333|NCT00991289|Drug|Pegylated interferon alfa-2a (PEG)|180 micrograms via subcutaneous injection once weekly
16252334|NCT00991289|Drug|Ribavirin (RBV)|Weight-based dosing; 1,000 mg daily, taken orally, for people weighing less than 75 kg or 1,200 mg for people weighing at least 75 kg.
16252335|NCT00991276|Drug|pregabalin|capsules; 300 mg once-per-day; 4 weeks of treatment
16252336|NCT00991276|Drug|placebo|capsules; 0 mg once-per-day; 4 weeks of treatment
16252337|NCT00991276|Drug|pramipexole|capsules; 0.5 mg once-per-day; 4 weeks of treatment
16252338|NCT00991263|Genetic|gene expression analysis|
16252339|NCT00991263|Genetic|polymerase chain reaction|
16252340|NCT00991263|Other|laboratory biomarker analysis|
16252341|NCT00991250|Biological|SentoClone®|SentoClone® are autologous tumour-reactive lymphocytes which are expanded and infused to the patient, where they have the opportunity to seek out and attack the primary tumour and metastases. The first step is to identify the tumour draining lymph node(s), which is done in parallel to surgical resection of the primary tumour or metastasis. The sentinel and/or metinel node(s), the initial meeting place between tumour antigen and the immune system, are further dissected and collected during the surgery. The lymphocytes are extracted from the collected lymph nodes and expanded in vitro, the lymphocytes are thereafter stimulated with tumour extract and returned to the patient intravenously as an autologous cell transfusion. The administered volume will be 100 ml for cell densities less than 3x106 cells/ml and 200 ml for cell densities of 3x106 cells/ml or more.
16252342|NCT00991250|Drug|Temodal® or Dacarbazine Medac®|"Dacarbazine (5-[3,3-Dimethyl-1-triazenyl]imidazole-4-carboxamide) is a widely used systemic treatment against advanced malignant melanoma. Dacarbazine is a cytostatic agent, which inhibits tumour growth by interfering with DNA-synthesises. The DNA-synthesis is inhibited by alkylation of the DNA molecule; however, it is unclear whether dacarbazine has other cytostatic impacts on cell mechanisms. Dacarbazine is inactive until liver passage, the liver converts dacarbazine to its reactive metabolites MTIC and HMMTIC, which alkylate DNA. Dacarbazine is light sensitive and needs to be administered intravenously.
~A newer analogue to dacarbazine, temozolomide (Temodal®), has been developed for oral administration. Temodal® is administered in capsules and is rapidly absorbed reaching peak concentrations after 20 minutes. Temodal® is converted to MTIC at physiological pH, the same reactive molecule as dacarbazine is metabolized to in the liver."
16252343|NCT00991237|Other|Pulsed Radiofrequency|Pulsed Radiofrequency
16252344|NCT00991224|Biological|WT-gag-TCR modified T cells|Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days.
16252345|NCT00991224|Biological|α/6-gag-TCR modified T cells|Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days.
16252346|NCT00991224|Other|STI or Drug Holiday|Subjects will stop taking antiviral medications for 16 weeks.
16252347|NCT00991211|Drug|Bendamustine|Comparison of Bendamustine + Rituximab with CHOP + Rituximab
16252348|NCT00991211|Drug|Standard chemotherapy CHOP + Ritiximab|Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy
16252349|NCT00991198|Drug|Topical oxygen|0.5% concentration of Topical oxygen
16252350|NCT00991198|Drug|Topical oxygen|0.25% concentration topical oxygen
16252351|NCT00991198|Drug|placebo|no O2
16252352|NCT00991172|Drug|REGN475|Single Subcutaneous injection dose level 1
16252353|NCT00991172|Drug|REGN475|Single subcutaneous injection dose level 2
16252354|NCT00991172|Drug|Placebo Injection|Placebo Subcutaneous injection
16252355|NCT00991159|Biological|RN316|Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.
16252356|NCT00991146|Drug|canakinumab|canakinumab
16252357|NCT00991133|Drug|Clofarabine incorporated into a 5-drug regimen|Clofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine
16252358|NCT00991120|Device|Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)|Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead
16252359|NCT00991107|Drug|HE3286|HE3286 20 mg (10 mg BID) for 28 days
16252360|NCT00991094|Other|Quality-of-Life Assessment|Complete questionnaires
16252361|NCT00991094|Other|Questionnaire Administration|Complete questionnaires
16252362|NCT00991081|Behavioral|Counseling|"Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling
~One week prior to the target quit date (TQD)
~Two weeks post-TQD
~Four weeks post-TQD"
16252363|NCT00991081|Behavioral|Self-help guide|A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
16252364|NCT00991081|Drug|Pharmacotherapy|"8-week course of genetically-tailored pharmacotherapy
~Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
~Participants with the A2 allele (CC) were assigned to receive bupropion"
16252365|NCT00991081|Behavioral|Genetic feedback, verbal|During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
16252366|NCT00991081|Behavioral|Genetic feedback, printed|After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype.
16252367|NCT00991068|Drug|Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch|Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.
16254989|NCT00973271|Drug|135 mg fenofibric acid|135 mg fenofibric acid
16252368|NCT00991055|Drug|Pioglitazone|"A total 16-week randomized, double-blind, controlled study to compare the efficacy and safety of pioglitazone 15mg once daily added to combination metformin plus sulfonylurea with those of placebo combining control group.
~(4-week run in period and 12-week pioglitazone 15mg added to combination therapy of sulfonylurea plus metformin and placebo control group in patients with type 2 diabetes)"
16252369|NCT00991042|Other|blood collect|Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.
16252370|NCT00991029|Drug|Clopidogrel|Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
16252371|NCT00991029|Drug|placebo|Loading dose of 8 tablets followed by one tablet daily for 89 days
16252372|NCT00991016|Drug|PF-04805712|ascending single and multiple doses starting at 30 mg
16252373|NCT00991003|Procedure|Colon capsule endoscopy|The PillCam® Colon Capsule is 11mm x 31mm in size (Figure 1), is equipped with two cameras acquiring pictures from both ends of the capsule at a rate of 4 frames per second (2 pictures per second and camera). The PillCam® Colon Capsule is automatically activated when it is removed from the package. It enters sleeping mode after approximately 10 minutes and starts transmitting again 1 h 45 min later. It has a total operating time of 8 - 10 hours. During the examination the patient wears a sensor array which is attached to the abdominal skin and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the Given Imaging workstation and a video is generated.
16252374|NCT00991003|Procedure|Conventional Colonoscopy|
16252375|NCT00990990|Drug|PNU-100480|100 mg BID for 14 days
16252376|NCT00990990|Drug|Placebo|to match 100 mg BID for 14 days
16252377|NCT00990990|Drug|PNU-100480|300 mg BID for 14 days
16252378|NCT00990990|Drug|Placebo|to match 300 mg BID for 14 days
16252379|NCT00990990|Drug|PNU-100480|600 mg BID for 14 days
16252380|NCT00990990|Drug|Placebo|to match 600 mg BID for 14 days
16252381|NCT00990990|Drug|PNU-100480|1200 mg QD for 14 days
16252382|NCT00990990|Drug|Placebo|to match 1200 mg QD for 14 days
16252383|NCT00990990|Drug|PNU-100480|600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
16252384|NCT00990990|Drug|Placebo|placebo to match 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
16252385|NCT00990990|Drug|PNU-100480|PNU-100480 dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
16252386|NCT00990990|Drug|Placebo|placebo to match dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28
16252387|NCT00990990|Drug|Linezolid|300 mg QD for 4 days (open label)
16252388|NCT00990977|Behavioral|mindfulness based stress reduction (MBSR)|MBSR is an 8-week course covering a total of 24 contact hours where the group of patients meet with an clinical psychologist certified as mindfulness instructor. The group will train the ability of mindfulness by specific awareness improving practises (body-scan) guided meditations and soft yoga. Between group-sessions participants are recommended to practice 45 minutes daily and to go through instructions in MBSR hand-outs. Participants will be given audio-CDs containing instructions and guides to support home practice.
16252389|NCT00990964|Device|Attain Success Lead|Attain Success Lead
16252390|NCT00990951|Drug|Senna alexandrina and associations|"Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub
~1 tablet PO twice a day"
16252391|NCT00990938|Drug|IMO-2125|IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.
16252392|NCT00990938|Drug|Saline|Subcutaneous injection once per week for four weeks
16252393|NCT00990925|Behavioral|Nutritional Lifestyle Modification Group|Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
16252394|NCT00990925|Other|Usual Care|Care as usual
16252395|NCT00990912|Drug|Carboplatin|IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity
16252396|NCT00990912|Drug|Irinotecan|IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
16252397|NCT00990912|Drug|Irinotecan|IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
16252398|NCT00990886|Drug|Placebo|Once daily for 12 weeks
16252399|NCT00990886|Drug|Oxybutynin chloride|15 mg once daily for 12 weeks
16252400|NCT00990873|Genetic|gene expression analysis|
16252401|NCT00990873|Genetic|microarray analysis|
16252402|NCT00990873|Genetic|reverse transcriptase-polymerase chain reaction|
16252403|NCT00990873|Other|laboratory biomarker analysis|
16252404|NCT00990860|Drug|doxorubicin|After identifying the target artery of HCC, doxorubicin will be infused through the target artery of HCC patient with lipiodol emulsion (dependent on the tumor size)
16252405|NCT00990860|Procedure|TACE (Transcatheter arterial chemoembolization)|TACE (Transcatheter arterial chemoembolization)
16252406|NCT00990847|Drug|Procaterol, Salbultamol|
16252407|NCT00990834|Drug|simvastatin|simvastatin 80 mg PO daily for one to eight months.
16252408|NCT00990821|Drug|90 mg MK-0517 (PS80)|MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes
16252409|NCT00990821|Drug|100 mg MK-0517 (PS80)|MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
16252410|NCT00990821|Drug|100 MK-0517 (PS80) + 2 mg midazolam|MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.
16252411|NCT00990821|Drug|115 mg MK-0517 (PS80)|MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
16252412|NCT00990821|Drug|150 mg MK-0517 (PS80)|MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
16252413|NCT00990821|Drug|40 mg MK-0517 (non-PS80)|MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
16252414|NCT00990821|Drug|100 mg MK-0517 (non-PS80)|MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
16252415|NCT00990821|Drug|150 mg MK-0517 (Non-PS80)|MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
16252416|NCT00990821|Drug|Placebo|Placebo matching MK-0517
16252417|NCT00990821|Drug|40 mg Aprepitant|Aprepitant, oral, tablet, single dose
16252423|NCT00990808|Drug|Comparator: placebo to atorvastatin|Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
16252424|NCT00990795|Drug|cyclosporine|Cyclosporine Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team.
16252425|NCT00990795|Drug|saline solution|Placebo Group: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose.
16252426|NCT00990782|Diagnostic Test|PillCam ESO Capsule Endoscope|Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
16252427|NCT00990769|Other|Depth of anesthesia|The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).
16252428|NCT00990756|Drug|PF-03526299|dry powder for inhalation, 1.396 mg, BID for 14 days
16252429|NCT00990756|Drug|PF-03526299|dry powder for inhalation, 4 mg, BID for 14 days
16252430|NCT00990743|Drug|SYL040012|Administration of single and multiple doses of SYL040012 in ophthalmic drops solution
16252431|NCT00990717|Biological|NK-92 cells|"Cells are administered as an intravenous infusion over one hour on days 1, 3 and 5 of each cycle of treatment. Patients can receive up to 6 cycles, which are administered monthly. Cell dosage is as follows:
~Level I: 1x10^9 cells/m^2
~Level II: 3x10^9 cells/m^2
~Level III: 5x10^9 cells/m^2"
16252432|NCT00990704|Drug|paricalcitol|Intravenous administration 3 times a week immediately before completion of dialysis
16252433|NCT00990704|Drug|maxacalcitol|Intravenous administration 3 times a week immediately before completion of dialysis
16252434|NCT00990691|Drug|Administration of a high dose of desipramine|"Administration of a daily dose of desipramine correlated with the patient's weight :
~From 15 to 25 kg : 50 mg ;
~From 26 to 35 kg : 75 mg ;
~From 36 to 45 kg : 100 mg ;
~> 46 kg : 150 mg."
16252435|NCT00990691|Drug|Administration of a low dose of desipramine|"Administration of a daily dose of desipramine correlated with the patient's weight :
~From 15 to 25 kg : 25 mg ;
~From 26 to 35 kg : 50 mg ;
~From 36 to 45 kg : 75 mg ;
~> 46 kg : 100 mg."
16252436|NCT00990691|Drug|Administration of a placebo|Administration of a daily dose of placebo
16252437|NCT00990678|Drug|Rocaltrol|tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily
16252438|NCT00990678|Drug|Vitamin D|tablets, vitamin D3, 30 microgram daily
16252439|NCT00990678|Drug|Calcium|tablets, 400 mg calcium, 3 times daily
16252440|NCT00990665|Device|CRT-D and LV lead (Quartet™ lead and Promote Q® device system)|Promote Q CRT-D and Quartet LV lead
16252441|NCT00990652|Drug|Bortezomib|Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).
16252442|NCT00990652|Drug|Temozolomide|After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days).
16252443|NCT00990639|Drug|candesartan for hepatic fibrosis|"Candesartan group(42 patients): oral candesartan at a daily dose of 8 mgin addition to ursodeoxycholic acid (UDCA, 600 mg/day) for 6 months.
~UDCA group(43 patients): oral ursodeoxycholic acid (UDCA, 600 mg/day) only for 6 months"
16252444|NCT00990613|Drug|Dimebon IR|A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
16252445|NCT00990613|Drug|Dimebon Transdermal|A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
16252446|NCT00990613|Drug|Dimebon Transdermal|A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
16252447|NCT00990613|Drug|Dimebon IR|A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered.
16252448|NCT00990613|Drug|Dimebon Transdermal|A single, to be determined dose of dimebon free base solution will be applied to the back over a 24 hour period. The dose level chosen will be determined based on the pharmacokinetic/safety profile of the 5 mg dose in Cohort 1. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site.
16252449|NCT00990600|Other|reduced number of pills|Switch to a fixed dose combination one pill/daily HAART
16252450|NCT00990587|Drug|Ciclopirox Olamine|Patients will take Ciclopirox Olamine at various doses depending on which dose level they come into the study at. Ciclopirox olamine will be administered orally as an aqueous suspension without food. The starting dose will be 5 mg/m2/day administered as a single dose daily for 5 days (one cycle). Once a MTD has been determined, the new patients that enter into the trial will then take it at that level.
16252451|NCT00990574|Device|Wiley Spinal Catheter|The WSCG (wiley spinal catheter group) will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Participants will receive the medication (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) in sequential doses.
16252452|NCT00990574|Device|Spinal Anesthesia Group (SAG)|"The SAG (spinal anesthesia group) will have their drugs (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) dosed intrathecally as a single shot while still in the sitting position."
16252453|NCT00990561|Drug|Ultravate ointment twice daily + LacHydrin lotion twice daily|Topical corticosteroid
16252454|NCT00990561|Drug|Ultravate ointment once daily + LacHydrin lotion twice daily|Topical corticosteroid
16252455|NCT00990535|Drug|Octreotide-LAR|Octreotide-LAR 30 mg administered every 21 days until progression
16252456|NCT00990522|Procedure|debridement|There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.
16252457|NCT00990509|Drug|Albumin|Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
16252458|NCT00990509|Drug|Placebo|Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
16252459|NCT00990509|Procedure|Brain MRI with and without contrast|"All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
~MRIs will be with and without contrast will be performed at:
~Baseline
~48 hours after enrollment(approximately Day 3)
~96 hours after drug treatment begins (approximately Day 5)"
16252460|NCT00990496|Drug|Fludarabine|30 mg/m2
16252461|NCT00990496|Drug|Cyclophosphamide|600 mg/m2
16252462|NCT00990496|Biological|CMV Specific Cytotoxic T Lymphocytes (CTL)|CTL Infusion (3 - 5 x 10E6 cells/kg)
16252463|NCT00990457|Behavioral|Weight Loss Diets Plus Exercise|"The weight loss diet will be either a low-carbohydrate diet or a low-fat, low-calorie diet. All participants will also be enrolled in a supervised exercise program.
~The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training."
16252464|NCT00990444|Drug|Insulin in Dextran Matrix|Fixed dose capsule with 100 IU of insulin in dextran matrix. Investigational drug or placebo are administered in conjunction with food intake on a background of metformin.
16252465|NCT00990431|Procedure|Fractional carbon dioxide laser treatment|The CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA) employs disposable tips with a diameter of 7 mm and 15 mm, the smaller being used for the peri-orbital region. The laser beam is delivered through multiple deflective and refractive elements and focused to a spot size of approximately 120 µm in diameter at incidence to the skin to deposit an array of laser beams across the surface. Pulse energy varies from 5 to 70 mJ and density from 5 to 70 %. The pulse duration is 10 msec. In the present study, patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %.
16252466|NCT00990431|Procedure|Fractional erbium:YAG laser treatment|The Er:YAG laser used in this study has a fractional handpiece (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany). By means of a microlens array the laser beam is divided into 13 x 13 small spots with 250 µm diameter each, spread over an area of 13 x 13 mm. A coverage of 5 % of the skin is achieved with a single pass. The pulse duration is 400 μsec. In this trial, we performed 4 passes (resulting in coverage of 20 % of the treated skin) with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses) to optimize thermal exposure.
16252467|NCT00990418|Drug|Separated (Two Part) E-TRANS (fentanyl HCl) System; Integrated E-TRANS (fentanyl HCl) System|
16252468|NCT00990405|Drug|Lansoprzole+Amoxicillin+Clarithromycin|Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
16252469|NCT00990392|Drug|Polysporin Triple Therapy ointment|Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
16252470|NCT00990392|Other|Petroleum Jelly|Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.
16252471|NCT00990366|Device|Cook´s biliary stent with an antireflux stent, normal biliary stent|arms are assigned randomly by closed envelope method
16252472|NCT00990340|Device|T-jet® containing TevTropin®|Needle-free delivery method for 14 days before cross-over to other arm
16252473|NCT00990340|Procedure|TevTropin® needle-syringe injection method|comparison of delivery methods for 14 days before cross-over to other arm
16252474|NCT00990327|Drug|Apadenoson SPECT-MPI|Apadenoson single bolus IV injection 100 or 150 ug
16252475|NCT00990327|Drug|Adenosine SPECT-MPI|Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.
16252476|NCT00990314|Drug|Beraprost Sodium Modified Release|
16252477|NCT00990301|Drug|Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.|test drug
16252478|NCT00990301|Drug|Uniretic® 15mg/25mg Tablets|reference drug
16252479|NCT00990288|Drug|Hemostatic Matrix|FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
16252480|NCT00990275|Other|ethanol|subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.
16252481|NCT00990262|Radiation|Cardiac Computed Tomography|"Localization of the heart position in a projectional topographic scan of the chest.
~Determination of contrast agent transit time: 10 ml contrast agent.
~CT coronary angiography: CT scan in spiral acquisition mode with 330 ms rotation time, 32 x 0.6 mm collimation, a pitch of 2.8 mm/rotation, tube voltage of 120 kVp, and maximum tube current of 850 mA. 80 ml of contrast agent, followed by 40 ml saline solution will be injected at a rate of 4 ml/s. The mean breath hold duration for this acquisition is approximately 13 seconds."
16252482|NCT00990249|Drug|Busulfan|Test Dose 32 mg/m^2 by vein over 45 minutes on Day -8; following doses on Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose.
16252483|NCT00990249|Drug|Clofarabine|40 mg/m^2 by vein over 1 hour daily Day -6 through Day -3
16252484|NCT00990249|Drug|Thymoglobulin|0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1; only patients with HLA nonidentical or unrelated donors
16252485|NCT00990249|Procedure|Stem Cell Transplant|Stem cell infusion on Day 0.
16252486|NCT00990236|Drug|Enoxaparin dose adjusted Lovenox based on TEG|Enoxaparin doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID.
16252487|NCT00990236|Drug|Enoxaparin 30 mg BID|Enoxaparin dose of 30 mg twice a day without any adjustments
16252488|NCT00990223|Drug|Eplerenone or Placebo|Eplerenone 100 mg or Placebo, daily for 10 days.
16252489|NCT00990197|Drug|Transdermal nicotine patch|Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours.
16252490|NCT00990184|Drug|Colesevelam|colesevelam HCl 3.75 g once daily orally with the evening meal
16252491|NCT00990184|Other|placebo|tablet (s) orally given with evening meal
16252492|NCT00990158|Drug|Phytonadione (Vitamin K1)|A daily dose of 150 micrograms of vitamin K medication given orally for a total of 7 months
16252493|NCT00990158|Drug|Placebo|A daily dose of matching placebo medication given orally for a total of 7 months
16252494|NCT00990145|Drug|EDP-322|
16252496|NCT00990132|Device|Long term oxygen therapy|LTOT established as per national guidelines
16252497|NCT00990119|Device|Vapotherm High Flow Therapy|use of high flow nasal cannula to support oxygenation and CO2 removal by flushing the nasopharynx with warmed, humidified respiratory gas at flow rates that exceed a patient's inspiratory flow rate
16252498|NCT00990119|Device|Non-invasive positive pressure ventilation|Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress.
16252499|NCT00990106|Drug|prazosin hydrochloride|"Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
16252500|NCT00990106|Drug|placebo|placebo
16252501|NCT00990093|Device|test intermittent catheter|CH 12 hydrophilic coated catheter
16252502|NCT00990093|Device|Intermittent catheterization|CH 12 hydrophilic catheter
16252503|NCT00990080|Biological|Pediacel® and Infanrix™-IPV/Hib|0.5 mL IM at 2,4 and 6 months of age
16252504|NCT00990067|Drug|3,4-Methylenedioxymethamphetamine|125 mg, single dose
16252505|NCT00990067|Drug|Duloxetine|120 mg two doses 12h and 2h before MDMA
16252506|NCT00990067|Drug|Placebo|capsules identical to MDMA or duloxetine
16252507|NCT00990054|Drug|Plerixafor|240 mcg/kg/dose and proceeding to escalating dose levels for determination of the single-dose maximum tolerated dose (MTD) provided that there are no unacceptable dose limiting toxicities
16252508|NCT00990028|Drug|Rosuvastatin|20 mg oral, for 10 days
16252509|NCT00990028|Drug|Placebo|20 mg vehicle
16252510|NCT00990015|Drug|PF-04308515|Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
16252511|NCT00990015|Drug|Placebo|Placebo solution/suspension to match active drug QD at a single dose.
16252512|NCT00989989|Drug|Ranibizumab|Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.
16252513|NCT00989989|Procedure|Laser photocoagulation|Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.
16252514|NCT00989989|Drug|Sham ranibizumab|Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.
16252515|NCT00989989|Procedure|Sham laser photocoagulation|Sham laser treatment administered at day 1.
16252516|NCT00989976|Behavioral|normal sleep times|8.5 h bedtimes
16252517|NCT00989976|Behavioral|bedtime restriction|4.5 h restricted bedtimes
16252518|NCT00989963|Drug|Beraprost Sodium Modified Release|60µg Tablets, twice a day for 12 weeks
16252519|NCT00989950|Drug|Daytrana|Daytrana patch 10-30 mg administered once daily for 9hr
16252520|NCT00989950|Drug|Daytrana|Daytrana 10-30 mg worn once daily for 10 hr wear
16252521|NCT00989950|Drug|Daytrana|Daytrana 10-30 mg worn once daily for 11 hr
16252522|NCT00989950|Drug|Daytrana|Daytrana 10-30 mg worn once daily for 12 hrs
16252523|NCT00989937|Drug|Oxytocin|20 IU BID or 40 IU BID
16252524|NCT00989937|Drug|Placebo|20 IU BID or 40 IU BID
16252525|NCT00989911|Drug|Bosentan|Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
16252526|NCT00989898|Other|Automated closed-loop insulin delivery|Insulin infusion rates via the insulin pump will be dictated by a computer-based control algorithm according to the CGM glucose readings and automatically adjusted on the pump.
16252527|NCT00989885|Other|Questionnaire and polysomnography|Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.
16252528|NCT00989872|Drug|EDP-322|
16252529|NCT00989859|Device|Plethysmographic monitoring|Plethysmographic monitoring
16252530|NCT00989846|Other|biomarker|measuring serum-biomarkers
16252531|NCT00989833|Drug|budesonide|400 yg x 1
16252532|NCT00989833|Drug|terbutaline|0.4 mg as-needed
16252533|NCT00989833|Drug|budesonide/formoterol|160/4.5 yg as-needed
16252534|NCT00989820|Drug|hyperbaric oxygen|30 session inhalation of 100% oxygen in a pressure chamber under 2.4 ATA for 90 minutes a day before surgery and 10 session hyperbaric oxygen therapy (as mentioned before) after surgery
16252535|NCT00989807|Drug|Aztreonam lysine|Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily
16252536|NCT00989794|Device|GelrinC|Applied once during surgery
16252537|NCT00989781|Radiation|3-D Ultrasound|One time pelvic ultrasound
16252538|NCT00989781|Drug|recombinant human chorionic gonadotropin|Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards
16252539|NCT00989781|Drug|Recombinant human follicle stimulating hormone|Recombinant human follicle stimulating hormone will be given iv and blood samples obtained before and 24 hr later.
16252540|NCT00989781|Drug|Adrenocorticotropin|Each subject will receive a 7 hr dose-response infusion of Adrenocorticotropin.
16252541|NCT00989781|Drug|Dexamethasone|Dexamethasone will be given prior to ACTH infusion test.
16252542|NCT00989781|Drug|Glucose|Each subject will undergo 3 oral glcuose tolerance tests.
16252543|NCT00989768|Drug|Botulinum Toxin Type A (Dysport®)|"Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
~-Dysport®: 5 units will be injected in the left or right forehead side."
16252544|NCT00989768|Drug|Botulinum Toxin Type A/Botox®|2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
16252646|NCT00989131|Drug|Paclical®|"250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle.
~Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments."
16252545|NCT00989768|Drug|Botulinum Toxin Type A/Dysport®|"Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
~-Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox."
16252546|NCT00989755|Other|Fax to Quit (F2Q)|Clinics in this group receive electronic and hard copies of all materials necessary for implementing Fax to Quit within their clinics.
16252547|NCT00989742|Drug|Doxycycline|50mg od
16252548|NCT00989742|Drug|Placebo|50mg od
16252549|NCT00989729|Drug|Methylprednisolone|A single preoperative dosage 30 mg/kg Methylprednisolone suspended in physiological saline (100 ml in total) given intravenously as a 30 minute infusion, 2 hours before surgery.
16252550|NCT00989729|Drug|Physiological Saline|A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
16252551|NCT00989716|Drug|Transdermal glyceryl trinitrate patch|5mg per day
16252552|NCT00989716|Drug|Pre-stroke antihypertensives|Continue or stop pre-stroke anti-hypertensives
16252553|NCT00989703|Drug|placebo|oral solution, daily for 14 days
16252554|NCT00989703|Drug|GLPG0259|oral solution
16252555|NCT00989703|Drug|Methotrexate|7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
16252556|NCT00989690|Drug|docetaxel|
16252557|NCT00989690|Drug|erlotinib hydrochloride|
16252558|NCT00989690|Drug|pemetrexed disodium|
16252559|NCT00989690|Genetic|fluorescence in situ hybridization|
16252560|NCT00989690|Genetic|mutation analysis|
16252561|NCT00989690|Genetic|proteomic profiling|
16252562|NCT00989690|Other|immunohistochemistry staining method|
16252563|NCT00989690|Other|laboratory biomarker analysis|
16252564|NCT00989690|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16252565|NCT00989690|Procedure|breath test|
16252566|NCT00989664|Biological|Tositumomab and Iodine I 131 Tositumomab|"Dosimetric Dose: 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by I-131 TST (35 mg of TST, of which 1-2 mg had been labeled with 5 mCi of Iodine-131) infused over 30 minutes (inclusive of a 10-minute flush).
~Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by I-131 TST (35 mg of TST labeled with enough Iodine-131 to administer the specified whole body radiation dose determined for the subject) infused over 30 minutes (inclusive of a 10-minute flush). The desired total body dose was 65 cGy for subjects with a baseline platelet count of 100,001-149,999/mm3 and 75 cGy for patients with a baseline platelet count ≥150,000/mm3. Obese patients received an attenuated dose by not including subject mass over 137% of their calculated lean body mass in their calculated lean body mass in the dose calculation."
16252573|NCT00989625|Drug|This is a pharmacokinetic study (Treximet)|This is a pharmacokinetic study to collect PK samples from subject after single dose.
16252574|NCT00989625|Drug|This is a pharmacokinetic study (Treximet)|This is a pharmacokinetic study to collect PK samples from subject after single dose.
16252575|NCT00989625|Drug|This is a pharmacokinetic study (Treximet)|This is a pharmacokinetic study to collect PK samples from subject after single dose.
16252576|NCT00989612|Biological|Influenza investigational vaccine GSK2340274A|Two intramuscular injections on Day 0 and Day 21, respectively
16252577|NCT00989599|Other|compress of Chamomilla recutita infusion|Patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy were treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day
16252578|NCT00989599|Other|compress of lukewarm water|Patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, in control group, were treated with a compress of lukewarm water for 20 minutes three times per day
16252579|NCT00989586|Biological|milatuzumab|Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36.
16252580|NCT00989586|Biological|veltuzumab|Patient will receive veltuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36.
16252581|NCT00989586|Procedure|Correlative/Special Studies|To correlate Fcγ receptor polymorphisms with response to treatment with the combination of veltuzumab and milatuzumab. Whole blood will be collected pre-treatment on day 1.
16252582|NCT00989586|Procedure|Quantitative T-, B-, and NK cell subsets|Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 pre-treatment on day 1, after induction (week 5, day 1), and prior to the start of therapy on day 1 week 12, day 1 week 36, and then every 4 months for one year.
16252583|NCT00989586|Procedure|Pharmacokinetics|To assess the pharmacokinetics of veltuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Pharmacokinetics will be assessed with blood samples collected at the following time points: immediately pre- and post-infusion on day 1 of weeks 1, 2, 4, 12 and 36. One additional sample will be collected each of weeks 5 through 10 (sample may be collected any day during each of these weeks).
16252584|NCT00989586|Procedure|Pharmacokinetics|To assess the pharmacokinetics of milatuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Pharmacokinetics will be assessed with blood samples collected at the following time points: immediately pre- and post-infusion on day 2 of week 1 and day 1 of weeks 2, 4, 12 and 36. Additional samples will be collected days 3 through 6 of week 1.
16252585|NCT00989586|Procedure|Human Anti-Human Antibodies|To monitor for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA) in patients receiving treatment with veltuzumab and milatuzumab. Patients will be monitored for the development of HAHA at the following timepoints: pre-treatment on day 1 of week 1, pre-treatment on day 1 of week 4, pre-treatment on day 1 of week 12, and pre-treatment on day 1 of week 36.
16252586|NCT00989586|Biological|veltuzumab and milatuzumab|Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36.
16252587|NCT00989573|Drug|Placebo|oral administration of placebo once-daily for 8 weeks
16252588|NCT00989573|Drug|OPC-6535|oral administration of OPC-6535 25 mg once-daily for 8 weeks
16252589|NCT00989573|Drug|OPC-6535|oral administration of OPC-6535 50 mg once-daily for 8 weeks
16252590|NCT00989560|Procedure|endoscopy|patients receive best treatment and care with an additional endoscopy
16252591|NCT00989547|Other|Umbilical Cord Blood VITA 34|Intervention type: Autologous Umbilical Cord Blood Transfusion
16252592|NCT00989534|Behavioral|Fixed restricted bedtimes|Sleep restricted to 5 hours per night for 8 nights
16252593|NCT00989534|Behavioral|Sleep restriction with circadian misalignment|Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep
16252594|NCT00989521|Drug|PUR003|PUR003 for inhalation
16252595|NCT00989521|Drug|Placebo|Normal saline for inhalation
16252596|NCT00989508|Drug|Perhexiline|Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
16252597|NCT00989508|Drug|Placebo marked PEXSIG|Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
16252598|NCT00989495|Device|Brace|Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
16252599|NCT00989482|Behavioral|Computer kiosk Education|computerized patient education; guidelines for physicians
16252600|NCT00989469|Drug|Nexavar (Sorafenib) and irinotecan (Campto)|Sorafenib administrated continuously orally 400 mg twice daily (a daily total dose of 800 mg). Irinotecan 180 mg/m² will be administered IV for 90 minutes every 2 weeks. The first dose of sorafenib will be administered after the first perfusion of irinotecan 180 mg/m² at the first infusion
16252601|NCT00989456|Behavioral|Self management education programme|"The structured patient educational self - management programme consists of 6 weekly sessions à 2 hours. The educational programme will take place prior to one of the two weekly training sessions.
~After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care. During the last month of the intervention year educational self - management will be offered twice and focus on themes that the participants wish to refresh."
16252602|NCT00989456|Behavioral|exercise only|6 week waiting list, followed by two weekly training sessions. After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care.
16252603|NCT00989443|Drug|Cidofovir gel|topical gel applied once a week for 3 weeks
16252604|NCT00989430|Behavioral|Prism Adaptation Treatment|Wearing prism goggles and performing visuomotor tasks during therapy sessions.
16252605|NCT00989417|Other|ACTIVATION of HOME MONITORING|Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
16252606|NCT00989404|Drug|Zanamivir|Rotahaler placebo 10mg BID 5 days
16252607|NCT00989404|Drug|Zanamivir|Rotahaler Zanamivir 10mg BID 5 days
16252608|NCT00989404|Drug|Zanamivir|Diskhaler Zanamivir 10mg BID 5 days
16252609|NCT00989391|Drug|PF-03654764|5mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252610|NCT00989391|Drug|placebo|orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252611|NCT00989391|Drug|PF-03654764|12mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252643|NCT00989170|Behavioral|Family Program for the Prevention of Weight Gain|The Family Workbook is a step-by-step instruction guide for families to use throughout the 6-month period, detailing healthy lifestyle. All handouts, instructions, activities, and a timeline of the program are laid out for families in this workbook.
16252922|NCT00987506|Device|XIENCE V®|Participants with placement of a XIENCE V® EESS
16252612|NCT00989391|Drug|placebo|orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252613|NCT00989391|Drug|PF-03654764|12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252614|NCT00989391|Drug|placebo|oral twice daily on Days 1-9 and once on Day 10. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
16252615|NCT00989378|Behavioral|baseline study|normal bedtimes
16252616|NCT00989365|Other|Aerobic training|Treadmill training
16252617|NCT00989352|Drug|Methotrexate|3g/m² i.v. max. 9 times
16252618|NCT00989352|Drug|Lomustine|110 mg/m² p.o., max. 3 times
16252619|NCT00989352|Drug|Procarbazine|60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
16252620|NCT00989352|Drug|Rituximab|375 mg/m² i.v., max. 10 times
16252621|NCT00989339|Drug|Twenty-four Hour TPN and Saline Infusion|Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
16252622|NCT00989326|Other|Home Monitoring|Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
16252623|NCT00989313|Drug|Lesion count|Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
16252624|NCT00989300|Drug|Treatment A - rabeprazole|20 mg rabeprazole sodium once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing
16252625|NCT00989300|Drug|Treatment B - omeprazole|20 mg omeprazole once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing
16252626|NCT00989300|Other|Treatment C - placebo|placebo once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing
16252627|NCT00989287|Biological|GSK2340272A|Two intramuscular injections in the deltoid region of the non-dominant arm.
16252628|NCT00989287|Biological|GSK2340269A|Two intramuscular injections in the deltoid region of the non-dominant arm.
16252629|NCT00989274|Biological|Vaccine Sanofi A(H1N1) 15 ug & trivalent|Grup 1: day 0: Vaccine trivalent (A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, and B/Brisbane/60/2008-like virus) Vaccine Sanofi A(H1N1) administrated 15 ug. (nonadjuvant); day 28 Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant);
16252630|NCT00989274|Biological|Vaccine Sanofi (H1N1) 15 ug.nonadyuvante|Grup 2: Day 0: Vaccine trivalent(A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, y B/Brisbane/60/2008-like virus); Day 28 Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant); day 56; Vaccine Sanofi A(H1N1) administrated a 15 ug. (nonadjuvant)
16252631|NCT00989274|Biological|Vaccine Sanofi A(H1N1) 7.5 ug|Grup 3: day 0: day 28 Vaccine Sanofi A(H1N1) administrated a 7.5 ug (non adjuvant); day 56; Vaccine Sanofi A(H1N1) administrated a 7.5 ug (nonadjuvant).
16252632|NCT00989261|Drug|Compound AC220|Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.
16252633|NCT00989248|Other|Aerobic and anaerobic capacity use aquatic exercises|Improve aerobic capacity use aquatic exercises in patients with Congestive Heart Failure
16252634|NCT00989235|Drug|Abatacept|IV solution, IV, 10 mg/Kg, Once monthly, 1 year
16252635|NCT00989235|Drug|Abatacept|IV solution, IV, 5 mg/Kg, Once monthly, 1 year
16252636|NCT00989222|Procedure|closed reduction and external fixation|Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
16252637|NCT00989222|Procedure|Internal fixation with a volar locked plate|Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
16252638|NCT00989209|Drug|Botulinum Toxin Type A|All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.
16252639|NCT00989209|Procedure|myofunctional therapy|All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.
16252640|NCT00989196|Biological|Human-cl rhFVIII|50 IU/kg for PK dose
16252641|NCT00989196|Biological|Kogenate FS|50 IU/kg for PK dose
16252642|NCT00989183|Other|Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma|Women undergoing an elective bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma Age range 21-55 years old
16252644|NCT00989170|Behavioral|Control Group|This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.
16252645|NCT00989157|Drug|Duloxetine|Single dose of 60 mg of duloxetine
16252647|NCT00989131|Drug|Taxol®|"175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle.
~Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments."
16252648|NCT00989118|Procedure|Laser treatment of ovarian endometrioma|Laser vaporization of ovarian endometrioma
16252649|NCT00989105|Other|immunohistochemistry staining method|
16252650|NCT00989105|Other|laboratory biomarker analysis|
16252651|NCT00989105|Other|pharmacological study|
16252652|NCT00989105|Procedure|computed tomography|
16252653|NCT00989105|Procedure|magnetic resonance imaging|
16252654|NCT00989105|Procedure|single photon emission computed tomography|
16252655|NCT00989105|Radiation|technetium Tc 99m demobesin-4|
16252656|NCT00989092|Biological|darbepoetin alfa|Administered subcutaneously.
16252657|NCT00989079|Drug|Ertugliflozin|Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.
16252658|NCT00989079|Drug|Placebo to Ertugliflozin|Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution
16252659|NCT00989053|Drug|escitalopram|10 mg/d for a duration of 8 weeks
16252660|NCT00989053|Drug|placebo|1 pill per day for 8 weeks
16252661|NCT00989040|Drug|usual treatment: Versatis|"To explore if the cognition is failed in treated patients suffering of neuropathic postzosteria pain.
~To see if treated patients with patch (Versatis®) have better cognition than treated patients without patch."
16252662|NCT00989027|Drug|Oxytocin|Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
16252663|NCT00989027|Drug|Ergonovine|Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
16252664|NCT00989027|Drug|Carboprost|Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
16252665|NCT00989027|Drug|Oxytocin and Ergonovine|Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
16252666|NCT00989027|Drug|Oxytocin and Carboprost|Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
16252667|NCT00989014|Drug|CD07805/47|0.5% Topical Gel
16252668|NCT00989014|Drug|CD07805/47|0.18% Topical Gel
16252669|NCT00989014|Drug|CD07805/47|0.07% Topical Gel
16252670|NCT00989014|Drug|CD07805/47 placebo|Vehicle Topical Gel
16252671|NCT00989001|Drug|Vernakalant|Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes
16252672|NCT00989001|Drug|Placebo|Injection
16252673|NCT00988988|Drug|AGEE cream|AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled. It will be used immediately after injection and repeated as needed.
16252674|NCT00988988|Drug|1% Steroid Cream|comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.
16252675|NCT00988988|Drug|topical placebo cream with no active ingredients|Cream to be applied immediately after injection and repeated as needed.
16252676|NCT00988975|Procedure|Insertion of pelvicol graft|Pelvicol graft
16252677|NCT00988962|Behavioral|cognitive behavioral training|electronic diaries, compliance checklists, urine screens, individual and group motivational counseling
16252678|NCT00988949|Drug|PF-04455242|Single oral 18 mg dose of PF-04455242.
16252679|NCT00988949|Drug|spiradoline|Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
16252680|NCT00988949|Other|Placebo|Oral placebo.
16252681|NCT00988949|Drug|spiradoline|Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
16252682|NCT00988949|Drug|PF-04455242|Single 30 mg oral dose of PF-04455242.
16252683|NCT00988949|Drug|spiradoline|Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
16252684|NCT00988936|Drug|[F-18]RGD-K5|Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with [F-18]RGD-K5
16252685|NCT00988923|Other|group A: HYPERTHERMIA|All patients were treated for 8 sessions, twice a week, for a total of 4 weeks of treatment. All patients were evaluated at baseline (T0) and after 4 weeks (T1). The first two sessions were sham-treatment for both groups
16252686|NCT00988923|Other|No intervention|the intervention tool was switched in off, only bolus was activated
16252687|NCT00988910|Drug|EE30-DRSP (Yasmin, BAY86-5131)|DRSP-containing combined oral contraceptives according to the normal routine praxis
16252688|NCT00988910|Drug|Other combined oral contraceptives|Other combined oral contraceptives according to the normal routine praxis
16252689|NCT00988897|Drug|OXALIPLATIN (SR96669)|Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
16252690|NCT00988897|Drug|5-FLUOROURACIL (5-FU)|Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
16252691|NCT00988897|Drug|LEUCOVORIN (LV)|Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
16252692|NCT00988897|Drug|BEVACIZUMAB|Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
16252693|NCT00988884|Biological|V503|V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6
16252694|NCT00988884|Biological|Comparator: Menactra™ (Concomitant)|Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
16252695|NCT00988884|Biological|Comparator: Adacel™ (Concomitant)|Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.
16252696|NCT00988884|Biological|Comparator: Menactra™ (Non-Concomitant)|Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
16252697|NCT00988884|Biological|Comparator: Adacel™ (Non-concomitant)|Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
16252698|NCT00988871|Device|PICC, CICC|PICC insertion, CICC (advanced venous access with pulmonary artery catheter) insertion
16252789|NCT00988351|Device|Continuous positive airway pressure|continuous positive airway pressure determined by polysomnography titration
16252699|NCT00988858|Drug|LY2603618|150 milligram per square meter (mg/m^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
16252700|NCT00988858|Drug|Pemetrexed|500 mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression
16252701|NCT00988845|Dietary Supplement|Indole-3-carbinol|200 mg bid po X 8 weeks
16252702|NCT00988832|Biological|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn's disease
16252703|NCT00988806|Drug|Levosimendan|"Patients included in the intervention group receive optimal drug therapy for heart failure symptoms and also infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours every 30 days.
~Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment."
16252704|NCT00988806|Drug|Placebo|"Patients included in the placebo group receive optimal drug therapy for heart failure and also infusion of placebo at the same infusion rate as levosimendan doses of 0.1 mcg / kg / min for 24 hours every 30 days.
~Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment."
16252705|NCT00988793|Procedure|Laparoscopic distal pancreatectomy|Comparison of two different types of surgery, laparoscopic versus distal pancreatectomy
16252706|NCT00988793|Procedure|Open distal pancreatectomy|Comparison of two different types of surgery, open versus laparoscopic distal pancreatectomy.
16252707|NCT00988780|Drug|maraviroc|"Maraviroc 600mg po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.
~Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.
~Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops."
16252708|NCT00988780|Drug|Placebo|"Placebo tablets po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.
~Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.
~Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops."
16252709|NCT00988767|Biological|DNA vaccine|patients received 1ml of DNA vaccine (1mg/ml) at Months 0,2,4,10
16252710|NCT00988754|Behavioral|School children and adolescents as health experts|Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents
16252711|NCT00988741|Drug|ARQ 197|The investigational drug ARQ 197 is supplied as capsules. A dose of 360 mg (3 capsules of 120 mg each) of ARQ 197 will be administered by mouth BID, once in the morning and once in the evening with meals, for a total daily dose of 720 mg. Under Amendment 2, a dose of 240 mg (2 capsules of 120 mg each) of ARQ 197/placebo will be administered by mouth BID, once in the morning and once in the evening with meals, for a total daily dose of 480 mg. A treatment cycle is defined as 4 weeks for both treatment arms. Cycles will be repeated every 4 weeks (28 days) based on toxicity and response.
16252712|NCT00988741|Drug|Placebo|The placebo is provided in a capsule form.
16252713|NCT00988728|Drug|SCH 900435 (Org 25935)|"Oral tablets, containing 8 mg of active substance, two tablets (i.e. 16 mg) to be taken twice daily in the morning after breakfast and in the evening after dinner during 4 weeks.
~Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with SCH 900435 plus 1 capsule with placebo per day)."
16252714|NCT00988728|Drug|Placebo|"Oral capsules and tablets containing excipients only.
~Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner."
16252715|NCT00988728|Drug|Olanzapine|"Oral capsules containing 15 mg of active substance, one capsule to be taken once daily after dinner for four weeks.
~Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with placebo plus 1 capsule with olanzapine per day)."
16252716|NCT00988715|Biological|Pretargeted Radioimmunotherapy|Antibody-streptavidin conjugate and radiolabeled DOTA-biotin, each given IV
16252717|NCT00988715|Drug|Cyclosporine|Given IV
16252718|NCT00988715|Drug|Mycophenolate Mofetil|Given PO
16252719|NCT00988715|Radiation|Total-Body Irradiation|Undergo total-body irradiation
16252720|NCT00988715|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo peripheral blood stem cell transplant
16252721|NCT00988715|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell transplant
16252722|NCT00988715|Drug|Fludarabine Phosphate|Given IV
16252723|NCT00988715|Other|Pharmacological Study|Correlative studies
16252724|NCT00988715|Other|Laboratory Biomarker Analysis|Correlative studies
16252725|NCT00988702|Behavioral|Dan Tian Breathing|Dan Tian Breathing for one month
16252726|NCT00988702|Behavioral|Progressive muscle training|Progressive muscle training for one month
16252727|NCT00988689|Other|Dietary Intervention|soup with or without starch
16252728|NCT00988663|Drug|memantine|patient will receive 5mg daily for 7day then 10 mgm daily
16252729|NCT00988663|Drug|Placebo|will give placebo that looks like memantine
16252730|NCT00988650|Other|isocaloric diet|
16252731|NCT00988650|Other|free living conditions|
16252732|NCT00988637|Drug|Vectical™ Ointment weekdays and Clobex® Spray weekends regimen|Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days
16252733|NCT00988637|Drug|Clobex® Spray morning and Vectical™ Ointment evening regimen|Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
16252734|NCT00988624|Drug|Dimebon IR Tablet|Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
16252735|NCT00988624|Drug|Dimebon MR1|Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
16252736|NCT00988624|Drug|Dimebon MR2|Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
16252737|NCT00988624|Drug|Dimebon MR3|Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
16252738|NCT00988624|Drug|Dimebon MR4|Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
16252739|NCT00988611|Other|Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma|Women undergoing an IVF/ART treatment cycle at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma, age range 18-44 years old
16252740|NCT00988598|Drug|PF-04447943|25 mg of PF-04447943 orally every 12 hours for 7 days
16252741|NCT00988598|Drug|Placebo|25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days
16252742|NCT00988585|Dietary Supplement|EPA 600|EPA 600 mg/day for 6 weeks
16252743|NCT00988585|Dietary Supplement|EPA 1800|1800 mg/day for 6 weeks
16252744|NCT00988585|Dietary Supplement|Olive Oil|600 mg/day for 6 weeks
16252745|NCT00988585|Dietary Supplement|DHA|600 mg/day for 6 weeks
16252746|NCT00988572|Other|Vestibular rehabilitation|The intervention program comprises of vestibular rehabilitation, at group sessions, twice a week for 9 weeks. The program is described in detail in table 1. Vestibular rehabilitation aims to facilitate rearrangement and recruitment of the control capacities of the vestibular system, by letting the patient be exposed to unstable body positions, such as standing on foam and performing head, trunk or eye-movements.
16252747|NCT00988559|Biological|DNA vaccination|vaccination with pNGVL4a-CRT/E7(detox)
16252748|NCT00988559|Device|Gene gun vaccine|8 micrograms (group 1) or 16 micrograms (group 2)
16252749|NCT00988559|Biological|intramuscular vaccination|1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly
16252750|NCT00988559|Biological|intra-lesional vaccine administration|1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally
16252751|NCT00988559|Procedure|therapeutic resection of the lesion|at week 15, all residual lesions will be resected
16252752|NCT00988559|Drug|imiquimod|imiquimod applied to the cervix by the physician
16252753|NCT00988546|Other|Computer based template for exam documentation|exam documentation performed using computer based template
16252754|NCT00988546|Other|Dictation for exam documentation|exam documentation performed using dictation, the standard practice
16252755|NCT00988533|Drug|0.5% Ivermectin Cream|Topical 0.5% ivermectin cream applied to scalp and hair on day 1
16252756|NCT00988520|Drug|Rocuronium bromide|Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
16252757|NCT00988520|Drug|Rocuronium bromide|Intubation dose of 0.6 mg/kg injection
16252758|NCT00988520|Drug|Rocuronium bromide|Intubation dose of 0.9 mg/kg injection
16252759|NCT00988520|Drug|Sevoflurane|0.5-2.0% intravenous maintenance anesthesia
16252760|NCT00988520|Drug|Propofol|4010 mg/kg/hr intravenous maintenance anesthesia
16252761|NCT00988507|Drug|Ferroquine (SSR97193)|"Pharmaceutical form: capsule
~Route of administration: oral"
16252762|NCT00988507|Drug|Placebo|"Pharmaceutical form: capsule
~Route of administration: oral"
16252763|NCT00988507|Drug|artesunate|"Pharmaceutical form: tablets
~Route of administration: oral"
16252764|NCT00988494|Drug|DE-105 ophthalmic solution|Topical ocular application
16252765|NCT00988494|Drug|DE-105 ophthalmic solution|Topical ocular application
16252766|NCT00988494|Drug|Placebo ophthalmic solution|Topical ocular application
16252767|NCT00988481|Drug|Topiramate|Topiramate titrated to 200mg/day over four weeks, for ten weeks
16252768|NCT00988468|Procedure|Manual Therapy|Grade 1 and 2 oscillatory manual mobilization of the tibiofemoral joint at various ranges of motion.
16252769|NCT00988468|Behavioral|Therapeutic Exercise|Subjects will perform 5 minutes of lower extremity cycle ergometer with minimal resistance followed by 10 minutes of resistance exercise to the quadriceps at 3 tibiofemoral positions (0 degrees, 30 degrees and 60 degrees of knee flexion).
16252770|NCT00988468|Behavioral|Video Observation|Subjects will watch a 15 minute video on a health topic unrelated to knee osteoarthritis.
16252771|NCT00988455|Radiation|photodynamic therapy|5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2
16252772|NCT00988442|Behavioral|Enhanced nursing telephone support|Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.
16252773|NCT00988442|Behavioral|Standard care|Usual ACTG site care.
16252774|NCT00988429|Drug|800 mg QD Eslicarbazepine acetate|Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
16252775|NCT00988429|Drug|1200 mg QD Eslicarbazepine acetate|Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
16252776|NCT00988429|Drug|Placebo|Placebo tablet given QD
16252777|NCT00988416|Procedure|PET-CT|Pancreas Protocol PET-CT
16252778|NCT00988403|Dietary Supplement|Fructan - 7.5|Subjects will consume 7.5 grams of fructan
16252779|NCT00988403|Dietary Supplement|Fructan - 10|Subjects will consume 10 grams of fructan
16252780|NCT00988403|Dietary Supplement|Fructan - 12.5|Subjects will consume 12.5 grams of fructan
16252781|NCT00988403|Dietary Supplement|Fructan -- 5 grams|Subjects will consume 5 grams fructan.
16252782|NCT00988390|Behavioral|Cognitive-behavioral, small-group format sessions|The intervention was delivered in either English- or Spanish-speaking groups of 5 to 8 mothers living with HIV twice weekly for 1.5 to 2 hours each over eight weeks (n = 16 sessions).
16252783|NCT00988377|Other|dietary intervention|whey protein 10-40 g
16252784|NCT00988377|Other|water control|Iso-volumetric (300 ml) water control (Crystal Springs, Canada)
16252785|NCT00988364|Drug|Simvastatin|Simvastatin 20mg daily for 3 months.
16252786|NCT00988364|Drug|Vytorin|Vytorin 20/10mg daily for 3 months.
16252787|NCT00988364|Drug|Placebo|Placebo one tablet daily times 3 months.
16252788|NCT00988364|Drug|Ezetimibe|Ezetimibe 10mg daily for 3 months.
16252790|NCT00988351|Device|Auto-adjusting positive airway pressure treatment|Pressure range 4-18 centimeters of water (cm H2O)
16252792|NCT00988325|Drug|Tamiflu|oral repeating dose
16252793|NCT00988312|Biological|autologous idiotype-protein pulsed dendritic cells|Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
16252794|NCT00988299|Other|exercise|exercise sessions at 45% and 60% of maximum effort
16252795|NCT00988286|Procedure|CEP, MEP, TMS|Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).
16252796|NCT00988273|Device|Confocal endomicroscopy|Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the control group will be compared to the diseased group.
16252797|NCT00988273|Device|Confocal endomicroscopy|Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
16252798|NCT00988260|Drug|Ganirelix|Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days
16252799|NCT00988260|Drug|Ganirelix|Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
16252800|NCT00988260|Drug|Ganirelix|Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
16252801|NCT00988247|Drug|Beclomethasone dipropionate|Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site).
16252802|NCT00988247|Drug|Placebo Nasal Aerosol|Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
16252803|NCT00988234|Procedure|SGPP|ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
16252804|NCT00988234|Procedure|SGTPP|ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
16252805|NCT00988234|Procedure|SGLP|ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
16252806|NCT00988234|Procedure|SGTLP|ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
16252807|NCT00988221|Drug|Tocilizumab|Tocilizumab was supplied as a sterile solution in vials.
16252808|NCT00988221|Drug|Placebo|Placebo to tocilizumab was supplied as a sterile solution in vials.
16252809|NCT00988208|Drug|Lenalidomide|25 mg lenalidomide orally once each day on Days 1-14
16252810|NCT00988208|Drug|Docetaxel|75 mg/m2 intravenous docetaxel on Day 1
16252811|NCT00988208|Drug|Prednisone|5 mg prednisone orally twice daily on each day of the treatment cycle
16252812|NCT00988208|Drug|Placebo|Oral placebo once each day on Days 1-14 of the treatment cycle
16252813|NCT00988195|Biological|Pegylated Recombinant Human Arginase I|Week 1 (Single Dose); Weeks 3 - 11 (Weekly Dose x 8 weeks)in 8 escalation doses
16252814|NCT00988195|Drug|Doxorubicin|Weeks 13-24 (once every 3 weeks)
16252815|NCT00988182|Other|dietary intervention|whey protein
16252816|NCT00988182|Other|water control|
16252817|NCT00988169|Drug|oral erlotinib and pulsed doses of oral AT-101|Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investigator at the start of cycle 2. Patients will continue receiving treatment on study until they refuse further therapy, develop evidence of progressive disease, or develop unacceptable toxicity or a medical condition that would, in the judgment of the investigator,
16252818|NCT00988156|Drug|Eslicarbazepine acetate (BIA 2-093)|"Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.
~The recommended target dose of double-blind study treatment will be 20mg/kg/day.
~Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year."
16252819|NCT00988156|Drug|Eslicarbazepine acetate|"Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.
~Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year."
16252820|NCT00988143|Biological|2009-2010 Trivalent Influenza Virus Vaccine|0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.
16252821|NCT00988143|Biological|2008-2009 Trivalent Influenza Virus Vaccine|0.25 mL, Intramuscular; 0.5 mL, Intramuscular.
16252822|NCT00988143|Biological|Quadrivalent Influenza Virus Vaccine|0.5 mL, Intramuscular
16252823|NCT00988130|Other|laboratory biomarker analysis|
16252824|NCT00988130|Other|questionnaire administration|
16252825|NCT00988130|Procedure|assessment of therapy complications|
16252826|NCT00988130|Procedure|high-intensity focused ultrasound ablation|
16252827|NCT00988130|Procedure|quality-of-life assessment|
16252828|NCT00988117|Drug|Rivastigmine Patch 9.5 cm2|Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.
16252829|NCT00988104|Behavioral|Cognitive Behavioral Therapy|CBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques.
16252830|NCT00988104|Behavioral|Supportive Counseling|Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
16252831|NCT00988091|Device|1.2% Sodium Hyaluronate|IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).
16252832|NCT00988091|Device|Buffered Saline|IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.
16252833|NCT00988078|Drug|Placebo|Capsule (without biologic action) administered three times a day for six months
16252834|NCT00988078|Drug|Metformin|Metformin 500mg three times a day for six months
16252835|NCT00988065|Drug|Placebo run-in dose|Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization
16252836|NCT00988065|Drug|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
16252837|NCT00988065|Drug|Sugammadex 16 mg/kg|Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
16252838|NCT00988065|Drug|Placebo|Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
16252839|NCT00988052|Drug|Laquinimod|One capsule containing 0.6 mg laquinimod to be administered orally once daily.
16252840|NCT00988039|Drug|Aluvia + 2NRTIs|"Aluvia (lopinavir/ritonavir 400mg/100mg), twice daily
~The choice of NRTIs will be at the discretion of the managing clinician and based on the local standard of care and drug availability, taking into account patient's previous drug exposure and side effects on first-line therapy."
16252841|NCT00988039|Drug|Aluvia + raltegravir|"Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily
~raltegravir (400mg) twice daily"
16252842|NCT00988039|Drug|Aluvia monotherapy|"Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily
~raltegravir (400mg) twice daily for the first 12 weeks only"
16252843|NCT00988026|Drug|Minocycline vs Lymecycline|Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
16252844|NCT00988013|Radiation|IM-TMI (3Gy)|Patients will receive 3Gy per day for 1 day.
16252845|NCT00988013|Radiation|IM-TMI (6Gy)|Patients will receive 3Gy per day for 2 days.
16252846|NCT00988013|Radiation|IM-TMI (9Gy)|Patients will receive 3Gy per day for 3 days.
16252847|NCT00988013|Radiation|IM-TMI (12Gy)|Patients will receive 3Gy per day for 4 days.
16252848|NCT00988000|Other|telephone consultation|alternative to face to face consultation for new referrals
16252849|NCT00988000|Other|No intervention|no alternative to face to face consultation
16252850|NCT00987987|Procedure|donor lymphocyte infusion|regulatory T cells depletion
16252851|NCT00987974|Drug|rosuvastatin|rosuvastatin 20 mg/day for 3 days.
16252852|NCT00987974|Drug|atorvastatin 3 days|atorvastatin 80 mg/day for 3 days.
16252853|NCT00987974|Drug|placebo|placebo for 3 days.
16252854|NCT00987974|Drug|rosuvastatin 7 days|rosuvastatin 20 mg/day for 7 days
16252855|NCT00987974|Drug|atorvastatin 7 days|atorvastatin 80 mg/day for 7 days.
16252856|NCT00987974|Drug|placebo 7 days|placebo 7 days
16252857|NCT00987961|Behavioral|Linkage|This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
16252858|NCT00987948|Drug|maraviroc (Selzentry)|dosage varies with other medications being taken; will follow package insert guidelines
16252859|NCT00987935|Drug|Sorafenib|400 mg twice daily
16252860|NCT00987935|Drug|BIBF 1120|Twice daily
16252861|NCT00987922|Device|Hypothermia|Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C
16252862|NCT00987909|Biological|Specific allergen immunotherapy (placebo)|Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
16252863|NCT00987909|Biological|Specific allergen immunotherapy|Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
16252864|NCT00987909|Biological|Specific allergen immunotherapy|Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks
16252865|NCT00987909|Biological|Specific allergen immunotherapy|Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks
16252866|NCT00987896|Device|Colonoscopy with Megachannel™ device loaded|Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon
16252867|NCT00987870|Drug|BFH772|
16252868|NCT00987870|Drug|Placebo|
16252869|NCT00987870|Drug|BFH772|
16252870|NCT00987870|Drug|Placebo|
16252871|NCT00987870|Drug|calcipotriol/betamethasone|
16252872|NCT00987857|Procedure|2 yearly endoscopy|2 yearly endoscopy versus endoscopy at need
16252873|NCT00987857|Procedure|comparison of screening methods|2 yearly endoscopy versus endoscopy at need
16252874|NCT00987857|Procedure|diagnostic endoscopic procedure|2 yearly endoscopy versus endoscopy at need
16252875|NCT00987857|Procedure|endoscopic biopsy|2 yearly endoscopy versus endoscopy at need
16252876|NCT00987857|Procedure|endoscopic procedure|2 yearly endoscopy versus endoscopy at need
16252877|NCT00987857|Procedure|quality-of-life assessment|QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
16252878|NCT00987857|Procedure|screening method|All Barretts patients to be screened
16252879|NCT00987844|Drug|Prucalopride|1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months
16252880|NCT00987831|Other|Group B SLE one blood donation|Blood drawing, history, physical examination,medical record review, questionnaires, completion of disease activity measures including SLEDAI,BILAG, CLASI,PGA,PROs,LFA investigational systems, BICLA, SRI
16252881|NCT00987831|Other|Blood drawing only Group C|Blood drawing and Brief medical history to ensure status of healthy control
16252882|NCT00987831|Drug|Group A SLE prospective study|Patients have history and physical exmamination at each visit. Blood is drawn at each visit. At baseline, any background immune suppressant is stopped and patients given depomedrol up to 160 mg IM which can be repeated up to four times in the first two weeks. Patients are seen again at week 2, 4 and monthly until the final flare visit at which time they donate blood, receive appropriate treatments and exit study. Patients may elect to continue in study for up to one year. The following disease activity measures are included: SLEDAI, BILAG, CLASI, PGA, PROs (including lupus PRO and SF-36 ant ptGA), joint counts, exploratory outcome measures,BICLA,SRI
16252883|NCT00987818|Other|Procalcitonin measurement|Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.
16252921|NCT00987532|Behavioral|twice weekly gym lessons|twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
16252884|NCT00987805|Dietary Supplement|Banhasasim-tang|Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study
16252885|NCT00987805|Dietary Supplement|Corn-starch granules|This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.
16252886|NCT00987792|Drug|Moxifloxacin (Avelox, BAY12-8039)|Hospitalized patients receiving Avelox according to local drug information
16252887|NCT00987779|Drug|Gabapentin|Period I: Tablet in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state
16252888|NCT00987779|Drug|Gabapentin|Period I: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Tablet in fasting state(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state
16252889|NCT00987766|Drug|erlotinib hydrochloride|Taken daily by mouth for 6 days every other week.
16252890|NCT00987766|Drug|gemcitabine hydrochloride|Given through a vein in the arm 1 time every other week.
16252891|NCT00987766|Drug|oxaliplatin|Given through a vein in the arm 1 time every other week.
16252892|NCT00987766|Other|laboratory biomarker analysis|Blood and tissue collection.
16252893|NCT00987753|Drug|L-377202|For each cycle, L-377202 will be administered as a 30-minute infusion every 3 weeks. The starting dose will be 20 mg/m2/week. Doses will be doubled until a patient experiences a greater than or equal to Grade 2 toxicity.
16252894|NCT00987740|Device|Hemolung Respiratory Assist System|Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive ventilation and then the Hemolung. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
16252895|NCT00987727|Drug|carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)|One drop in each eye three to six times daily, as needed
16252896|NCT00987727|Drug|sodium hyaluronate 0.18% (VISMED® Multi)|One drop in each eye three to six times daily, as needed
16252897|NCT00987714|Procedure|Protocolized care|Organ Procurement Coordinators will utilize a hemodynamic monitor and algorithm for donor management of cardiac index, pulse pressure variation and mean arterial pressure.
16252898|NCT00987701|Drug|Ringer's Lactate|Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section
16252899|NCT00987701|Drug|Six percent hydroxyethyl starch|Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section
16252900|NCT00987688|Other|Hypothermia|exposure: Early and sustained hypothermia. Hypothermia will initially be induced by infusion of up to 2L ice cold saline. Following a safety assessment the patient will be rapidly cooled to 33C using surface temperature control equipment. They will be maintained at 33C for 72 hours. Rewarming will occur at a rate of 1C/4hrs and will be titrated to intracranial pressure (ICP) control and BP.
16252901|NCT00987675|Other|pharmacological study|
16252902|NCT00987675|Other|questionnaire administration|
16252903|NCT00987675|Procedure|assessment of therapy complications|
16252904|NCT00987675|Procedure|high-intensity focused ultrasound ablation|
16252905|NCT00987675|Procedure|quality-of-life assessment|
16252906|NCT00987662|Drug|Irbesartan|Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg.
16252907|NCT00987662|Drug|Amlodipine|Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg
16252908|NCT00987636|Drug|Zoledronic acid|"intravenously at 28 day intervals beginning with cycle 6 of VAC/VAI consolidation chemotherapy for a total period of nine months.
~Patients < 18 years will receive 0.05 mg/kg BW by IV infusion 30 min-1 h.
~Patients >= 18 years will receive a bodyweight-dependent dose:
~Patients >40kg receive 4 mg by IV infusion 30 min-1h Patients 20-40 kg receive 2 mg by IV infusion 30 min-1h"
16252909|NCT00987636|Drug|Busulfan|intravenously, day -6 to d -3 adults: 0.8 mg/kg body weight (BW) children and adolescents: <9 kg= 1mg/kg BW 9 - <16 kg= 1.2 mg/kg BW 16 - 23 kg= 1.1 mg/kg BW >23 - 34 kg= 0.95 mg/kg BW >34 kg = 0.8 mg/kg BW
16252910|NCT00987636|Drug|Treosulfan|12 g/m² d-5 to d-3
16252911|NCT00987623|Device|nelfilcon A contact lens|Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
16252912|NCT00987623|Device|narafilcon A contact lens|Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.
16252913|NCT00987610|Device|Percutaneous coronary intervention (PCI)|PCI for chronic total occlusion is performed using either arm of guidewire
16252914|NCT00987597|Behavioral|Technique of in-vivo exposure (cigarette) and mental image exposure (craving)|Nicotine replacement
16252915|NCT00987597|Behavioral|conventional follow-up|nicotinic substitutes
16252916|NCT00987558|Drug|Eslicarbazepine acetate|
16252917|NCT00987558|Drug|Simvastatin|
16252918|NCT00987545|Drug|QAX576|QAX576 injection
16252919|NCT00987545|Drug|QAX576 placebo|Placebo to QAX576 injection
16252920|NCT00987532|Behavioral|parent-focused intervention|The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.
16252923|NCT00987493|Biological|rituximab|day 1 at a fixed dose of 375mg/m2
16252924|NCT00987493|Drug|bendamustine hydrochloride|Bendamustine at day 1 and 2 according to the dose escalation in phase I, and at the recommended dose in phase II: 70mg/m2.
16252925|NCT00987493|Drug|lenalidomide|Lenalidomide at days 1-21 according to the dose escalation in phase I, and at the recommended dose in phase II: 10mg
16252926|NCT00987480|Drug|Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.|There are three parts in this transplant study. 1) There will be a pre-transplant - preparation - period to see if patient qualifies for the transplant study. This will be done as an outpatient and lasts 2-4 weeks. Once this is completed, there will be 2) the transplant period itself, during which the patient will be admitted and will be an inpatient. This period usually last for 4-6 weeks. Following that, there will be a 3) post transplant period, during which the patient will be watched carefully and monitored in clinic as an out patient. The post transplant period lasts from three months to one year.
16252927|NCT00987480|Device|CliniMACS device|CD34+ T-cell depleted peripheral blood stem cell transplant
16252928|NCT00987467|Drug|Cyclosporin 0.05% ophthalmic|Cyclosporine 0.05% ophthalmic solution, 1 drop 6 times in both eyes daily for first month, then 1 drop 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator.
16252929|NCT00987454|Drug|Epoetin Alfa|40,000 IU given as subcutaneous injection weekly up to 3 doses
16252930|NCT00987454|Drug|Sodium Chloride 0.9%|1 m/L given as subcutaneous injection weekly up to 3 doses
16252931|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.125% plus sufentanil 0.3 microgram
16252932|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.125% plus sufentanil 0.4 microgram
16252933|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.125% plus sufentanil 0.5 microgram
16252934|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.0625% plus sufentanil 0.4 microgram
16252935|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.1875% plus sufentanil 0.4 microgram
16252936|NCT00987441|Drug|Ropivacaine and sufentanil|Ropivacaine 0.25% plus sufentanil 0.4 microgram
16252937|NCT00987428|Procedure|ultrasonography with or not sphincterotomy|Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
16252938|NCT00987428|Procedure|Usual procedure|The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.
16252939|NCT00987415|Drug|allopurinol|Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
16252940|NCT00987415|Drug|sugar pill|Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
16252941|NCT00987402|Other|Plain soap and water (PSW)|Presence or absence of infection
16252942|NCT00987402|Other|Alcohol-based hand rub (ABHR)|Presence or absence of infection
16252943|NCT00987389|Procedure|Plasma Exchange|Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.
16252944|NCT00987389|Other|No Plasma Exchange|No plasma exchange.
16252945|NCT00987389|Drug|Glucocorticoids [Standard Dose]|During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a standard regimen.
16252946|NCT00987389|Drug|Glucocorticoids [Reduced Dose]|During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a reduced regimen.
16252947|NCT00987376|Device|Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy|C11 Choline, C11 Acetate PET and MRI
16252948|NCT00987363|Other|Intraarterial infusion of autologous bone marrow cells|Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
16252949|NCT00987350|Device|LectraJet|LectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself.
16252950|NCT00987350|Device|TIV by jet injection|Administration of seasonal trivalent influenza vaccine (TIV) by jet injection
16252951|NCT00987350|Biological|Seasonal Trivalent Influenza Vaccine|Licensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe.
16252952|NCT00987337|Drug|Filibuvir|300 mg BID
16252953|NCT00987337|Drug|Filibuvir|600 mg BID
16252954|NCT00987337|Drug|Placebo|BID
16252955|NCT00987324|Device|Taxus stent|Implantation of paclitaxel-eluting stent
16252956|NCT00987324|Device|SeQuent Please|Dilation with SeQuent Please (paclitaxel-eluting balloon)
16252957|NCT00987324|Device|Conventional Balloon Catheter|Ryuijin, Trek
16252958|NCT00987311|Dietary Supplement|1- Dairy drink containing probiotics A|1- Dairy drink containing probiotics A
16252959|NCT00987311|Dietary Supplement|2- Dairy drink containing probiotics B|2- Dairy drink containing probiotics B
16252960|NCT00987311|Dietary Supplement|3- Dairy drink without probiotics (control)|3- Dairy drink without probiotics (control)
16252961|NCT00987298|Device|Visceral fat mass measurement|Total body DXA measurement, Abdominal CT scan
16252962|NCT00987285|Behavioral|CASM +|Computer Assisted Self Management plus Social Support
16252963|NCT00987285|Behavioral|CASM|Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
16252964|NCT00987272|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%|
16252965|NCT00987272|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.1%|
16252966|NCT00987272|Drug|Olopatadine 0.2% Vehicle|Inactive ingredients used as placebo comparator
16252967|NCT00987272|Drug|Olopatadine 0.1% Vehicle|Inactive ingredients used as placebo comparator
16252968|NCT00987246|Drug|Placebo Gel|Topical
16252969|NCT00987246|Drug|LAS41005|Topical
16252971|NCT00987233|Drug|triamcinolone acetonide aqueous nasal spray (Apotex Inc.)|It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
16252972|NCT00987233|Drug|triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)|It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
16252973|NCT00987233|Drug|Placebo|It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
16252974|NCT00987220|Drug|Placebo|Oral
16252975|NCT00987220|Drug|donepezil (Aricept)|5mg oral
16252976|NCT00987207|Drug|cyclosporine A|a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
16252977|NCT00987207|Other|No injection|No cyclosporine A is administered before aortic cross-declamping.
16252978|NCT00987168|Drug|Sandostatine LP|Intramuscular injection of Sandostatine LP, once per month Dosage : 10 mg, 20 mg, 30 mg
16252979|NCT00987155|Device|Ergometry|MetamaxII Cortex ergospirometry system (Cortex Biophysik GmbH, Germany). Arm cycling ergometer (Ergomed 840L, Siemens, GermanyMonark, Sweden), Electrically braked wheelchair ergometer (VP 100, Handisoft France)
16252980|NCT00987142|Drug|CX501|Cultured chimeric skin
16252981|NCT00987142|Device|Occlusive non adherent dressing|Application of an occlusive non adherent dressing in the skin donor site
16252982|NCT00987116|Drug|Prednisone - Azathioprine|"Rapid strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for improvement or minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 0.75 mg/kg/day.
~Classical strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 1.5 mg/kg/2days."
16252983|NCT00987103|Drug|Tacrolimus|Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
16252984|NCT00987090|Biological|Clinic and neuropsychologic evaluation|evaluation at the inclusion and 18 months after
16252985|NCT00987090|Radiation|MRI|intervention at the inclusion and 18 months after
16252986|NCT00987090|Procedure|PET|18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.
16252987|NCT00987090|Biological|Apolipoprotein E genotyping|genotyping at the inclusion
16252988|NCT00987090|Biological|Study of cerebrospinal fluid|intervention at the inclusion
16252989|NCT00987077|Device|Selective Retina Therapy (SRT)|SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).
16252990|NCT00987064|Device|Temperature controlled Laminar Airflow (Protexo)|The intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone.
16252991|NCT00987064|Device|Placebo TLA|TLA treatment with disabled filtration function
16252992|NCT00987051|Procedure|Detection of sentinel node|Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection
16252993|NCT00987038|Drug|PF-04171327 25 mg|One 25 mg tablet administered once a day for 15 days
16252994|NCT00987038|Drug|Midazolam 2 mg|Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15
16252995|NCT00987025|Behavioral|Telehealth|Use of telehealth blood pressure station every week
16252996|NCT00987025|Behavioral|Educational materials|Control
16252997|NCT00987012|Dietary Supplement|Pomegranate juice|Twice daily ingestion of pomegranate juice over 4-5 days
16252998|NCT00987012|Dietary Supplement|Placebo drink|Twice daily ingestion of placebo drink over 4-5 days
16252999|NCT00986999|Drug|rosuvastatin|rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years
16253000|NCT00986986|Drug|extended release niacin|Active arm subjects will start extended release niacin (Niaspan) at 500 mg per night (by mouth once a daily) and titrate to a maximum tolerated dose (not exceeding 1500 mg per night (by mouth once a day) for 12 weeks. Titration will depend on patient tolerability of Niaspan.
16253001|NCT00986973|Drug|Sapropterin|All subjects will receive 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects will be examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects Phe and tyrosine levels will be monitored weekly during the study and subjects will keep 3-day diet records to allow for calculation of Phe intake.
16253002|NCT00986960|Drug|repository corticotropin injection|IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
16253003|NCT00986960|Drug|Saline|I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
16253004|NCT00986947|Drug|IVIg and rituximab|"A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
16253005|NCT00986921|Drug|mifepristone 200 mg|mifepristone would be given the day before the procedure
16253006|NCT00986921|Device|osmotic dilator insertion|osmotic dilators (3-6) would be inserted as usual the day before the procedure
16253394|NCT00984386|Drug|Placebo|Intradermal placebo, 100μl administered once before punch biopsy
16253007|NCT00986895|Drug|HPN-100|HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. HPN-100 is broken down to phenylbuteric acid (PBA). PBA is converted to phenylacetic acid (PAA) that is the active metabolite. Three teaspoons of HPN-100 (~17.4mL) delivers an equivalent amount of PBA to40 tablets of NaPBA.
16253008|NCT00986882|Drug|SAF312A|
16253009|NCT00986882|Drug|Placebo|
16253010|NCT00986882|Drug|Ibuprofen|
16253011|NCT00986869|Procedure|Doppler echocardiogram|All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy
16253012|NCT00986856|Drug|Fucidin® cream|
16253013|NCT00986843|Drug|HM30181AK tablet + Irinotecan tablets|HM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets
16253014|NCT00986830|Device|FinESS Sinus Treatment|
16253015|NCT00986817|Drug|Terlipressin|Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.
16253016|NCT00986817|Drug|Placebo|albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.
16253017|NCT00986804|Drug|Decitabine|
16253018|NCT00986791|Other|GSP-A|6-week Gold Standard Programme (5 meetings in total) consisting a structured education programme, hotline, thiamine and B-vitamins (300 mg daily), Alcohol Withdrawal Prophylaxis and intervention (Benzodiazepines)and controlled Disulfiram support (200 mg x 2 weekly)
16253019|NCT00986778|Drug|Lamivudine|Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
16253020|NCT00986778|Drug|Entecavir|Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
16253021|NCT00986778|Drug|Adefovir|Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
16253022|NCT00986765|Drug|Lovenox® (enoxaparin)|Injectable solution 4000 UI
16253023|NCT00986765|Drug|Aspegic ® (Aspirin)|100 mg/day
16253024|NCT00986752|Device|Stenting (Smart Stent)|Nitinol stent
16253025|NCT00986752|Device|Stenting after PEB (Smart Stent, Invatec)|Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
16253026|NCT00986752|Procedure|Atherectomy (SilverHawk device)|Atherectomy
16253027|NCT00986713|Drug|Amphotericin B|Aerosolized Amphotericin B,2mg/day or 10mg/day
16253028|NCT00986700|Dietary Supplement|late night meal|Three different kinds of late night meal each for 2 days.
16253029|NCT00986674|Biological|cixutumumab|Given IV
16253030|NCT00986674|Drug|carboplatin|Given IV
16253031|NCT00986674|Drug|paclitaxel|Given IV
16253032|NCT00986674|Biological|cetuximab|Given IV
16253033|NCT00986661|Drug|PV-10 (10% rose bengal disodium)|Subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv, or 0.50 mL PV-10 per cc Lv).
16253034|NCT00986609|Biological|MUC-1 peptide vaccine|Given subcutaneously
16253035|NCT00986609|Biological|poly ICLC|Given intramuscularly
16253036|NCT00986609|Biological|MUC1 peptide-poly-ICLC adjuvant vaccine|Receive adjuvant vaccination
16253037|NCT00986609|Other|laboratory biomarker analysis|Correlative studies
16253038|NCT00986609|Other|enzyme-linked immunosorbent assay|Correlative studies
16253039|NCT00986609|Other|flow cytometry|Correlative studies
16253040|NCT00986596|Dietary Supplement|vitamin D3|4000 IU once daily by mouth for 4 months
16253041|NCT00986596|Dietary Supplement|Placebo|microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
16253042|NCT00986583|Drug|Succinylcholine|Succinylcholine will be administered pre-induction over a period of 5 seconds
16253043|NCT00986570|Biological|Botulinum Toxin A|100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
16253044|NCT00986557|Biological|adoptive immunotherapy|
16253045|NCT00986557|Biological|alemtuzumab|
16253046|NCT00986557|Biological|in vitro-treated peripheral blood lymphocyte therapy|
16253047|NCT00986557|Drug|foscarnet sodium|
16253048|NCT00986557|Drug|ganciclovir|
16253049|NCT00986557|Genetic|polymerase chain reaction|
16253050|NCT00986557|Procedure|allogeneic hematopoietic stem cell transplantation|
16253051|NCT00986557|Procedure|infection prophylaxis and management|
16253052|NCT00986557|Procedure|peripheral blood stem cell transplantation|
16253053|NCT00986557|Procedure|standard follow-up care|
16253054|NCT00986557|Radiation|radiation therapy|
16253055|NCT00986544|Procedure|no drain|drain positioned on the skin
16253056|NCT00986544|Procedure|drain positioned|drain positioned in the subhepatic space
16253057|NCT00986544|Procedure|drain not positioned|Drain positioned in the abdominal wall
16253058|NCT00986531|Drug|AZD8529|2 capsules by mouth for 3 days
16253059|NCT00986531|Drug|Placebo to match AZD8529|2 capsules by mouth for 3 days
16253060|NCT00986518|Biological|Adaptive autologous cell immunotherapy|each patient will undergo a blood cytapheresis to collect circulating lymphocytes. Ex-vivo cell sorting procedure will deplete patient's collected lymphocytes from regulatory T cells. Autologous Treg-depleted lymphocytes will be administered to the patient following a 5-day reduced intensity chemo-therapeutic conditioning.
16253061|NCT00986505|Drug|Lidocaine|Intravenous lidocaine once a week
16253062|NCT00986479|Drug|AZD6765|Single IV infusion of 150 mg AZD6765.
16253063|NCT00986479|Drug|Placebo to AZD6765|Single IV infusion of Placebo to AZD6765
16253064|NCT00986466|Dietary Supplement|exercise and vitamin D supplementation|20 µg (800 IU) of vitamin D per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months
16253065|NCT00986466|Dietary Supplement|exercise and vitamin D supplementation|placebo per day for two years supervised training two times a week for 12 months, and once a week during the next 12 months
16253066|NCT00986466|Dietary Supplement|exercise and vitamin D supplementation|20 µg (800 IU) of vitamin D per day for two years no supervised training (maintenance of their current level of physical activity)
16253067|NCT00986466|Dietary Supplement|exercise and vitamin D supplementation|placebo per day for two years no supervised training (maintenance of their current level of physical activity)
16253068|NCT00986453|Device|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
16253069|NCT00986453|Procedure|Traditional Electrosurgery with scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
16253070|NCT00986440|Drug|CS-7017|CS-7017
16253071|NCT00986440|Drug|Placebo|Placebo
16253072|NCT00986427|Drug|Restasis (cyclosporine ophthalmic emulsion) 0.05%|cyclosporine ophthalmic emulsion 0.05%
16253073|NCT00986427|Drug|Refresh® Dry Eye therapy|Emulsion contains glycerin 1% and polysorbate 80
16253074|NCT00986414|Drug|AFQ056|
16253075|NCT00986414|Drug|AFQ056|
16253076|NCT00986414|Drug|AFQ056|
16253077|NCT00986414|Drug|AFQ056|
16253078|NCT00986414|Drug|AFQ056|
16253079|NCT00986414|Drug|Placebo|
16253080|NCT00986401|Drug|Trospium Chloride (Sanctura XR®)|extended release, 60 mg, oral daily
16253081|NCT00986401|Drug|Metformin hydrochloride (Glucophage®)|immediate release, 500mg
16253082|NCT00986375|Behavioral|Intervention Group (IG)|patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
16253083|NCT00986375|Behavioral|Active Control Group (ACG)|Patients in the ACG will get an interactive computerized standard program
16253084|NCT00986362|Drug|Ocriplasmin|175µg ocriplasmin intravitreal injection
16253085|NCT00986362|Drug|Placebo|Placebo intravitreal injection
16253086|NCT00986349|Device|EndoBarrier Liner|52 week treatment of EnoBarrier Liner
16253087|NCT00986336|Drug|topiramate|1-25 mg plus 1-100 mg tablet twice daily for 2 weeks (250 mg/day)
16253088|NCT00986336|Drug|topiramate|2-100 mg tablets twice daily for 2 weeks (400 mg/day)
16253089|NCT00986336|Drug|risperidone|Twice daily, individualized dosing to stabilization at 1-6 mg/day.
16253090|NCT00986336|Drug|topiramate|2-25 mg tablets twice daily for 2 weeks (100 mg/day)
16253091|NCT00986323|Device|Temperature controlled Laminar Airflow (TLA)|Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).
16253092|NCT00986323|Device|Placebo TLA|Placebo TLA (without filtration and TLA function)
16253093|NCT00986310|Drug|Fluoxetine|Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.
16253094|NCT00986310|Drug|Placebo|Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.
16253095|NCT00986297|Radiation|hypofractionated radiation therapy|hypofractionated radiation therapy
16253096|NCT00986284|Drug|gefitinib|Patients with EGFR mutation in exon 19 or 21 will be administrated with gefitinib as neoadjuvant therapy. Then evaluated for response and then operation for operable patients.
16253097|NCT00986271|Procedure|EVLI was determinated by PiCCO plus system.|
16253098|NCT00986258|Drug|Tapentadol Prolonged Release|"Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:
~if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
~if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
~if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.
~Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached."
16253099|NCT00986245|Drug|Ropinirole Prolonged release|Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
16253100|NCT00986232|Biological|Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
16253101|NCT00986232|Biological|Comparator: M-M-R II|A single 0.5 mL subcutaneous injection at Day 0
16253102|NCT00986232|Biological|Comparator: PUVV|A single 0.5 mL subcutaneous injection at Day 0
16253103|NCT00986206|Diagnostic Test|Biomarker LPA and HE4|Non Interventional Trial
16253104|NCT00986193|Procedure|Transapical Aortic Valve Implantation|Insertion of a stent valve using catheter-based technique through a mini thoracotomy
16253105|NCT00986193|Procedure|Conventional Aortic Valve Surgery|Operation using heart-lung machine, with insertion of a biological artificial heart valve
16253106|NCT00986180|Drug|NUCYNTA|50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain
16253107|NCT00986180|Drug|Oxycodone IR|5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain
16253108|NCT00986167|Drug|Quetiapine XR|The daily dose of oral Quetiapine XR at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. The dose will be adjusted within the usual effective dose range of 400 to 800 mg/day, depending on the clinical response and tolerability of the individual patient.
16253109|NCT00986154|Drug|edoxaban tosylate(DU-176b)|edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
16253110|NCT00986154|Drug|low molecular weight heparin/unfractionated heparin|"LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
16253111|NCT00986154|Drug|warfarin|tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
16253112|NCT00986141|Procedure|Surgery|Selective Laser Trabeculoplasty for glaucoma
16253113|NCT00986141|Procedure|Selective Laser Trabeculoplasty|Glaucoma Treatment
16253114|NCT00986128|Drug|topiramate|100 mg tablet twice daily for 3 weeks
16253115|NCT00986128|Drug|topiramate|One 100 mg and one 200 mg tablet twice daily for 3 weeks
16253395|NCT00984360|Drug|Naltrexone|380mg extended-release, given once by intramuscular gluteal injection
16253116|NCT00986115|Drug|Memantine|After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
16253117|NCT00986115|Drug|Placebo|After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
16253118|NCT00986102|Drug|doripenem|500mg vial by injection every 8 hours for 5 to 14 days
16253119|NCT00986076|Drug|Enoxaparin|Enoxaparin 40 mg / 500 ml in Balanced Salt Solution
16253120|NCT00986076|Drug|Balanced Salt Solution|Intraocular infusion of Balanced Salt solution
16253121|NCT00986063|Genetic|Genetic test for NVP induced rash|The genotype statuses that capable of predict the cutaneous side effects from nevirapine
16253122|NCT00986063|Other|3TC/D4T/NVP or 3TC/AZT/NVP|Standard HAART for AIDS patients in Thailand
16253123|NCT00986050|Drug|Abciximab|Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
16253124|NCT00986050|Device|bare metal stent prokinetic, chrono, skylor or bluemedical|bare metal stent in culprit artery in acute myocardial infarction
16253125|NCT00986050|Device|drug eluting stent (sirolimus eluting) - CYPHER stent|stent implantation in culprit artery in acute myocardial infarction
16253126|NCT00986037|Drug|ABT-308|Single IV doses
16253127|NCT00986037|Drug|ABT-308|Multiple SC doses x 3
16253128|NCT00986037|Drug|Placebo|Single IV dose
16253129|NCT00986037|Drug|Placebo|Multiple SC doses x 3
16253130|NCT00986024|Behavioral|aerobic exercise|carried out 3 times per week for 12 weeks
16253131|NCT00986024|Behavioral|strength training|carried out 3 times per week for 12 weeks
16253132|NCT00986011|Other|questionnaire administration|
16253133|NCT00986011|Other|study of socioeconomic and demographic variables|
16253134|NCT00986011|Other|survey administration|
16253135|NCT00986011|Procedure|study of high risk factors|
16253136|NCT00985998|Drug|Nimotuzumab and chemotherapy|"The chemotherapy treament：docetaxel( 75mg/m2/d,every21days,for4~6cycles) and cisplatin(total dose 75mg/m2 on day 2,3,4,every21days,for4~6cycles).
~the nimotuzumab treatment:3 levels (200mg/w,400mg/w,600mg/w,weekly,for12~18 weeks)."
16253137|NCT00985985|Drug|Nicotine|2 mg or 4 mg nicotine lozenge
16253138|NCT00985985|Drug|Placebo|placebo lozenge
16253139|NCT00985972|Behavioral|Physical Activity and Nutrition Education|School-based interventions involving Physical Activity or/and Nutrition Education.
16253140|NCT00985959|Drug|JNJ-26866138 0.7 mg/m2|JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles.
16253141|NCT00985959|Drug|JNJ-26866138 1.0 mg/m2|JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles
16253142|NCT00985959|Drug|JNJ-26866138 1.3 mg/m2|Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.
16253143|NCT00985959|Drug|Melphalan|Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
16253144|NCT00985959|Drug|Prednisolone|Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
16253145|NCT00985946|Drug|panobinostat (LBH589)|Panobinostat will be taken once daily at 20 mg three times a week (every Monday, Wednesday, Friday). It will be taken as long as patients are benefiting from treatment.
16253146|NCT00985933|Drug|AZD8529|6 capsules by mouth 1 time 12 to 24 prior to assessments
16253147|NCT00985933|Drug|Placebo to match AZD8529|6 capsules by mouth 1 time 12 to 24 hours prior to assessments
16253148|NCT00985920|Drug|tranexamic acid|"Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo).
~The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues."
16253149|NCT00985920|Drug|Placebo|"Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo).
~The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues."
16253150|NCT00985907|Drug|Doxil, melphalan, bortezomib|"Doxil®: IV over 30-60 min, Day 1 q28d
~Melphalan: IV over 30 min, Day 1 q28d
~Velcade®: IV bolus, Day 1, 4, 8, 11 q28d
~Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
~Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
~Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
~Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2"
16253151|NCT00985894|Other|Online Teledermatology Care|Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.
16253152|NCT00985894|Other|Conventional in Office Care|Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
16253341|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253153|NCT00985881|Device|Custom prosthetic socket with mechanical vibrators (stochastic resonance)|Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system
16253154|NCT00985881|Device|Conventional prosthetic socket (current clinical practice)|No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.
16253155|NCT00985868|Drug|multikinase inhibitor AT9283|
16253156|NCT00985868|Other|enzyme-linked immunosorbent assay|
16253157|NCT00985868|Other|immunohistochemistry staining method|
16253158|NCT00985868|Other|laboratory biomarker analysis|
16253159|NCT00985868|Other|pharmacological study|
16253160|NCT00985855|Drug|cisplatin, vinorlebine, cetuximab|patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
16253161|NCT00985855|Drug|cisplatine, etoposide, cetuximab|patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
16253162|NCT00985842|Device|Pe-Lite and sleeve suspension socket|Prosthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket.
16253163|NCT00985842|Device|Total Surface bearing a socket with a sleeve suspension but without suction|Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket.
16253164|NCT00985842|Device|Total surface bearing suction socket with a pin lock suspension|Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee.
16253165|NCT00985842|Device|Total surface bearing suction socket with a sleeve suspension|Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension.
16253166|NCT00985842|Device|Vacuum-assisted socket system (Harmony System, Otto Bock)|Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb.
16253167|NCT00985829|Radiation|photodynamic therapy|treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
16253168|NCT00985816|Dietary Supplement|Lactobacillus Reuteri|L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
16253169|NCT00985816|Dietary Supplement|Placebo|Placebo
16253170|NCT00985803|Other|Physical Activity: Cardio training (CT)|"The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test.
~The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling."
16253171|NCT00985803|Other|Physical Activity: Endurance exercise training (ET)|"The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test.
~The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling."
16253172|NCT00985790|Biological|Influenza vaccine GSK2321138A|Intramuscular injection
16253173|NCT00985790|Biological|Fluarix™|Intramuscular injection
16253174|NCT00985777|Drug|Vitamin E δ-Tocotrienol|Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The investigator (or designee) will have records of the number of participants treated within a specific cohort and will determine which treatment cohort to assign newly enrolled participants.
16253175|NCT00985764|Procedure|cesarean delivery|
16253176|NCT00985751|Biological|Pneumococcal vaccine GSK2189242A (formulation 1)|Three doses will be administered intramuscularly, at Month 0, 2 and 6.
16253177|NCT00985751|Biological|Pneumococcal vaccine GSK2189242A (formulation 2)|Three doses will be administered intramuscularly, at Month 0, 2 and 6
16253178|NCT00985751|Biological|Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)|Three doses will be administered intramuscularly, at Month 0, 2 and 6
16253179|NCT00985751|Biological|Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)|Three doses will be administered intramuscularly, at Month 0, 2 and 6
16253180|NCT00985751|Biological|Pneumococcal vaccine GSK1024850A|Three doses will be administered intramuscularly, at Month 0, 2 and 6
16253181|NCT00985738|Drug|Dutasteride|Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.
16253182|NCT00985738|Other|Placebo|The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.
16253183|NCT00985725|Drug|SPD489 (Lisdexamfetamine dimesylate)|Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
16253184|NCT00985725|Drug|Matching placebo|oral, once daily
16253185|NCT00985712|Drug|Insulin Lispro|subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
16253186|NCT00985712|Drug|Huminsulin Regular|subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
16253187|NCT00985712|Device|HumaPen Memoir|subcutaneously, daily for 24 weeks
16253188|NCT00985712|Device|HumaPen Luxura|subcutaneously, daily for 24 weeks
16253189|NCT00985699|Genetic|polymorphism analysis|
16253190|NCT00985699|Other|laboratory biomarker analysis|
16253191|NCT00985699|Other|pharmacogenomic studies|
16253243|NCT00985322|Drug|ACE inhibitor Ramipril|The ACE inhibitor (Ramipril) will be started at 1.25 mg/day and will be up-titrated to 2.5 mg/day, to 5 mg/day, and then to 10 mg/day according to BP control and tolerability.
16253244|NCT00985322|Drug|non-RAS inhibitor antihypertensive therapy|Blood Pressure lowering regimen not including RAS inhibitors
16253392|NCT00984386|Drug|Zesteem|Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
16253192|NCT00985686|Other|LEAP Project|In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles.
16253193|NCT00985673|Biological|GSK2340274A|Two intramuscular injections
16253194|NCT00985673|Biological|GSK2340273A|Two intramuscular injections
16253195|NCT00985673|Biological|Seasonal trivalent influenza vaccine (TIV)|Single intramuscular injection
16253196|NCT00985673|Biological|Saline placebo|Single intramuscular injection
16253197|NCT00985660|Drug|Nisoldipine Extended-release Tablets, 30 mg|1 x 30 mg Tablet under fasting conditions
16253198|NCT00985660|Drug|Sular® Extended Release Tablets, 30 mg|1 x 30 mg Tablet under fasting conditions
16253199|NCT00985647|Drug|Lamivudine (3TC)|"3TC 300mg/150mg participants will receive 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days.
~3TC 150mg/300mg participants will receive 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days."
16253200|NCT00985634|Device|LeGoo|LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon.
16253201|NCT00985634|Device|Control|Vessel loops
16253202|NCT00985621|Biological|tanezumab 10 mg|tanezumab 10 mg one dose at weeks 0 and 8
16253203|NCT00985621|Biological|tanezumab 5 mg|tanezumab 5 mg one dose at weeks 0 and 8
16253204|NCT00985621|Drug|oxycodone|oxycodone CR, 10-40 mg q12h
16253205|NCT00985621|Other|placebo|placebo
16253206|NCT00985608|Drug|Group A: NCA 600 mg+antibiotics|NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
16253207|NCT00985608|Drug|Group B: antibiotic treatment (control)|patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
16253208|NCT00985556|Drug|capecitabine|Given orally
16253209|NCT00985556|Drug|oxaliplatin|Given IV
16253210|NCT00985556|Drug|tegafur-gimeracil-oteracil potassium|Given orally
16253211|NCT00985543|Drug|lopinavir/ritonavir|Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
16253212|NCT00985530|Drug|Tamibarotene|Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle
16253213|NCT00985530|Drug|Arsenic trioxide|Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.
16253214|NCT00985517|Biological|CERE-120: Adeno-Associated Virus Delivery of Neurturin|
16253215|NCT00985517|Procedure|Sham Surgery|
16253216|NCT00985504|Drug|Duloxetine|60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks.
16253217|NCT00985504|Drug|Escitalopram|10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks.
16253218|NCT00985491|Device|Endobarrier Liner|Medical device placed endoscopically in the duodenum
16253219|NCT00985478|Drug|SLV342|25 mg once daily - Maximal Tolerated Dose
16253220|NCT00985478|Drug|placebo|matching placebo
16253221|NCT00985465|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, 1 or 2 doses
16253222|NCT00985452|Other|GlowCaps Connect system|The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.
16253223|NCT00985452|Other|Glow cap system - deactivated|The Glow cap system - deactivated is an electronic medication system, which will track medication adherence.
16253224|NCT00985439|Drug|Diclofenac Test (lower dose)|18-mg Single dose
16253225|NCT00985439|Drug|Diclofenac Test (upper dose)|35-mg Single dose
16253226|NCT00985439|Drug|Celecoxib 400 mg|Capsules 2 x 200 mg Single-dose
16253227|NCT00985439|Drug|Placebo|Capsules 2 Single-dose
16253228|NCT00985426|Biological|HEPLISAV-B|Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
16253229|NCT00985426|Biological|Engerix-B|Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
16253230|NCT00985426|Other|Placebo|Placebo(saline) intramuscular (IM) injection at Week 8
16253231|NCT00985400|Behavioral|Exercise Program|Resistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day
16253232|NCT00985400|Behavioral|Telephone-based intervention|Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.
16253233|NCT00985400|Other|Counseling intervention|Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter.
16253234|NCT00985400|Other|Questionnaire administration|
16253235|NCT00985400|Behavioral|Relaxation Program|Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
16253236|NCT00985387|Drug|Solifenacin|oral
16253237|NCT00985374|Drug|RAD001|5mg or 10mg po daily
16253238|NCT00985374|Drug|RG1507|16mg/kg iv every 3 weeks
16253239|NCT00985361|Dietary Supplement|Vitamin D3 2000 international units daily|Vitamin D3 2000 international unit tablets once daily for 3 months
16253240|NCT00985361|Dietary Supplement|Vitamin C 500mg daily|Vitamin C 500mg tablets once daily for 3 months
16253241|NCT00985348|Drug|Levetiracetam (Keppra)|"Test Drug :
~Levetiracetam dry syrup
~Reference Drug :
~500 mg oral tablets of Levetiracetam. Frequency: Single Dose"
16253242|NCT00985335|Other|Neem Based External Application Cream|Apply externally 3-4 times per day
16253289|NCT00984971|Drug|HEC Placebo|Placebo gel applied rectally
16253245|NCT00985283|Behavioral|Preventive home visit|in-home visit by a trained occupational therapist to assess older adult's living context and occupational performance and to provide recommendations for changes or continuation of behavior or context
16253246|NCT00985283|Behavioral|minimal intervention|provision of information related to services and health promotion for older adults as a low-cost minimal alternative to the intervention
16253247|NCT00985270|Drug|Rifampicin|
16253248|NCT00985270|Drug|Placebo|
16253249|NCT00985257|Device|DIDGET (Investigational Blood Glucose Monitoring System)|Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.
16253250|NCT00985244|Drug|Azithromycin|Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.
16253251|NCT00985244|Drug|Placebo|Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.
16253252|NCT00985231|Device|PureVision Multi-Focal contact lenses|Contact lenses to be worn on a daily wear basis for 2 weeks.
16253253|NCT00985231|Device|SofLens59 contact lens|Contact lenses to be worn on a daily wear basis for 2 weeks.
16253254|NCT00985218|Device|SMART System|microfluidic embryo culture system
16253255|NCT00985218|Device|Culture dish|Standard IVF culture dish
16253256|NCT00985205|Dietary Supplement|Enteral Glutamine|0.5g/kg/day powdered glutamine to be mixed in with water and given via nasogastric or feeding tube q4 hrs or TID or QID if po.
16253257|NCT00985205|Dietary Supplement|Placebo|Maltodextrin mixed with water given via NG or feeding tube Q 4 hours or TID or QID if po.
16253258|NCT00985192|Drug|everolimus|
16253259|NCT00985192|Other|laboratory biomarker analysis|
16253260|NCT00985179|Behavioral|Intervention Group (IG)|Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
16253261|NCT00985166|Biological|ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)|A Single 0.5 mL subcutaneous injection at Day 1
16253262|NCT00985166|Biological|Comparator: M-M-R II|A Single 0.5 mL subcutaneous injection at Day 1
16253263|NCT00985166|Biological|Comparator: Varivax|A Single 0.5 mL subcutaneous injection at Day 1
16253264|NCT00985166|Biological|Comparator: Placebo|A Single 0.5 mL subcutaneous placebo injection at Day 1
16253265|NCT00985153|Biological|Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|A Single 0.5 mL subcutaneous injection at Day 0
16253266|NCT00985153|Biological|Comparator: Varivax|A Single 0.5 mL subcutaneous injection at Day 0
16253267|NCT00985153|Biological|Comparator: M-M-R II|A Single 0.5 mL subcutaneous injection at Day 0
16253268|NCT00985140|Radiation|Total Skin Electron Beam Therapy (TSEBT)|The purpose of the study is to examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gray) in patients who have mycosis fungoides (MF) staged as IB to IIIB.
16253269|NCT00985127|Drug|placebo|administered daily for 21 days
16253270|NCT00985127|Drug|BCX4208|Administered daily for 21 days.
16253271|NCT00985114|Device|EndoBarrier|EndoBarrier implant
16253272|NCT00985114|Behavioral|Diet + Lifestyle Counseling|Multidisciplinary lifestyle and nutritional counseling
16253273|NCT00985088|Biological|GSK2340274A|one or two intramuscular injections
16253274|NCT00985088|Biological|GSK2340273A|one or two intramuscular injections
16253275|NCT00985088|Biological|Saline placebo|One injection
16253276|NCT00985062|Procedure|Mild Ovarian Stimulation Treatment|Administration of a fixed dose of 150 IU/day rFSH s.c. (Puregon® NV Organon, Oss, The Netherlands) from cycle day 5 onwards. As soon as the leading follicle reached a diameter of 14mm, a GnRH-antagonist (Orgalutran®, NV Organon, Oss, The Netherlands) was administered at 0.25 mg/day s.c.. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered.
16253277|NCT00985062|Procedure|Conventional Ovarian Stimulation Treatment|Administration of GnRH agonist Triptorelin (Decapeptyl®, Ferring BV, Hoofddorp, The Netherlands) at 0.1 mg/day s.c., starting on cycle day 21 of the menstrual cycle preceding the actual stimulation cycle. After two weeks of the GnRH regimen, co-treatment with rFSH 225 IU/day s.c. (Puregon®, NV Organon, Oss, The Netherlands) was initiated. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered
16253278|NCT00985036|Procedure|Blood test|an additional vial of blood will be obtained at the time of MRI or at the time of routine blood tests ordered by the medical oncologist. In other words, there will be no extra needle sticks. Just an extra vial of blood will be taken during a routine blood test
16253279|NCT00985023|Procedure|Steel screw fixation of Lisfranc fracture-dislocation.|Stainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
16253280|NCT00985023|Procedure|Absorbable screw fixation of Lisfranc fracture-dislocations.|Bioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.
16253281|NCT00984997|Procedure|Surgery|Segmentectomy or lobectomy with en bloc resection of the involved chest.
16253282|NCT00984997|Radiation|Chest Irradiation|Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.
16253283|NCT00984997|Drug|Cisplatin|50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
16253284|NCT00984997|Drug|Etoposide|given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.
16253285|NCT00984997|Radiation|Prophylactic Cranial Irradiation|25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.
16253286|NCT00984984|Drug|methylprednisolone PO|10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days
16253287|NCT00984984|Drug|methylprednisolone IV|IV Methylprednisolone 1 g in 50 ml NaCl 0,9% (syringe pump 30 mn to 2 h) and 10 capsules of placebo, every day during 3 days
16253288|NCT00984971|Drug|Tenofovir|Topical gel applied rectally
16253290|NCT00984971|Drug|Open label tenofovir tablet|All participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)
16253291|NCT00984958|Device|Bulkamid|injection of Bulkamid in the urethra
16253292|NCT00984958|Device|Bulkamid expectation|expectance
16253293|NCT00984945|Biological|H5 VLP pandemic influenza vaccine 5 µg|0.5 mL, IM, 2 injections 21 days apart
16253294|NCT00984945|Biological|H5 VLP pandemic influenza vaccine 10 µg|0.5 mL, IM, 2 injections 21 days apart
16253295|NCT00984945|Biological|H5 VLP pandemic influenza vaccine 20 µg|0.5 mL, IM, two injections 21 days apart
16253296|NCT00984945|Biological|Placebo|0.5 mL, IM, two injections 21 days apart
16253297|NCT00984932|Drug|Rosuvastatin|40 mg of rosuvastatin daily
16253298|NCT00984919|Other|high performance liquid chromatography|
16253299|NCT00984919|Other|laboratory biomarker analysis|
16253300|NCT00984919|Other|mass spectrometry|
16253301|NCT00984906|Other|Empty inhalers|Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler
16253302|NCT00984893|Drug|zoledronic acid|
16253303|NCT00984893|Drug|Any oral bisphosphonates marketed in Canada|
16253304|NCT00984880|Drug|AZD3043|Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)
16253305|NCT00984867|Drug|Dapagliflozin|10 mg tablet, oral, once daily, 48 weeks
16253306|NCT00984867|Drug|Placebo|Matching placebo tablet
16253307|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 50mM (1.41mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253308|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253309|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253310|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 300mM (8.46mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253311|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253312|NCT00984854|Drug|Juvidex|Intradermal Juvidex, 100μl of 600mM (16.93mg/100μl) administered just prior to wounding and 200μl administered 24 h later
16253313|NCT00984854|Drug|Placebo|Intradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later
16253314|NCT00984841|Other|Tailored letter|
16253315|NCT00984828|Drug|velcade|velcade 1.3mg/m2 D1, 4, 8 and 11
16253316|NCT00984815|Drug|HZT-501|Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
16253317|NCT00984802|Drug|CMX-2043|Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
16253318|NCT00984802|Drug|Placebo control|Vehicle solution for IV administration single dose.
16253319|NCT00984789|Drug|Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)|0.55mg ethinylestradiol and 2.1mg gestodene
16253320|NCT00984789|Drug|Norelgestromin/Ethinylestradiol (EVRA)|0.6mg ethinylestradiol and 6mg norelgestromin
16253321|NCT00984776|Other|Contrast enhanced MRI with Gadofosveset|0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter
16253322|NCT00984763|Biological|AMA1-C1/Alhydrogel® + CPG 7909|A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909)
16253323|NCT00984750|Drug|acetyl-L-carnitine/statin (simvastatin)|"acetyl-L-carnitine: 4 tablets of 500 mg a day
~simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability"
16253324|NCT00984750|Drug|placebo|placebo: 4 tablets of 500 mg a day simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability
16253325|NCT00984737|Drug|Insulin|"Capillary glucose measurements of Group 2 and Group 3 will be performed during hospitalization and will be treated when they are over 180mg/dl.
~Short acting oral anti-diabetic drugs will be given to patients who refuse insulin injection."
16253326|NCT00984724|Behavioral|Standard Treatment (ST)|Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
16253327|NCT00984724|Behavioral|Telephone Counseling|"MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period
~MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period"
16253328|NCT00984724|Behavioral|Quitline|Letter referring participants to a Quitline providing quit smoking services.
16253329|NCT00984724|Behavioral|Nicotine Replacement Therapy (NRT)|300 pieces of nicotine gum issued at baseline visit.
16253330|NCT00984698|Behavioral|Cognitive Behavioral Social Rhythm Group Therapy|12 weeks, 2h structured group therapy
16253331|NCT00984698|Behavioral|Present Centered Group Therapy|12 weeks, 2h relatively unstructured group therapy
16253332|NCT00984659|Drug|Fluticasone propionate/salmeterol combination product|Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks
16253333|NCT00984659|Drug|Salmeterol|Salmeterol 50mcg DISKUS twice a day for 8 weeks
16253334|NCT00984659|Drug|Placebo|Placebo DISKUS twice a day for 8 weeks
16253335|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253336|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253337|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253338|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253339|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253340|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253393|NCT00984386|Drug|Zesteem|Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
16253342|NCT00984646|Drug|Prevascar|Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253343|NCT00984646|Drug|Placebo|Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
16253344|NCT00984633|Drug|Rocuronium bromide (Org 9426)|0.6 mg/kg injection intubation dose
16253345|NCT00984633|Drug|Rocuronium bromide (Org 9426)|0.9 mg/kg injection intubation dose
16253346|NCT00984633|Drug|Sevoflurane|0.5-2.0% intravenous maintenance anesthesia
16253347|NCT00984633|Drug|Propofol|4-10 mg/kg/hr maintenance anesthesia
16253348|NCT00984620|Drug|BI 201335|BI 201335
16253349|NCT00984620|Drug|BI 201335|BI 201335
16253350|NCT00984620|Drug|Pegylated Interferon-alpha (IFN)|Pegylated Interferon-alpha
16253351|NCT00984620|Drug|Ribavirin (RBV)|Ribavirin (RBV)
16253352|NCT00984607|Procedure|barium sulfate tablet|After a standard upper GI evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring. A spot radiograph was obtained once the barium tablet was in the gastric pouch and the dilute liquid barium was passing through the gastric band stoma.
16253353|NCT00984594|Other|Primary injury site|Autograft will be placed in the primary defect site.
16253354|NCT00984594|Other|Backfill site|Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.
16253355|NCT00984581|Drug|Avotermin|Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
16253356|NCT00984581|Drug|Avotermin|Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
16253357|NCT00984581|Drug|Placebo|Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
16253358|NCT00984568|Biological|Infliximab|Infliximab intravenous infusion at a dose of 5 mg/kg.
16253359|NCT00984568|Drug|Prednisolone|Oral prednisolone 40 mg/day or 1 mg/kg/day depending upon participant response.
16253360|NCT00984568|Drug|5-aminosalicylic acid|5-ASA administered orally at a dose of 2 g/day.
16253361|NCT00984568|Drug|Azathioprine|AZA administered orally at a dose of 2.0-2.5 mg/kg/day.
16253362|NCT00984542|Drug|bendamustine hydrochloride|Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
16253363|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding
16253364|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
16253365|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding
16253366|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
16253367|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding
16253368|NCT00984516|Drug|Juvidex|Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
16253369|NCT00984516|Drug|Placebo|Intradermal Placebo, 100μl administered once prior to wounding
16253370|NCT00984516|Drug|Placebo|Intradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
16253371|NCT00984503|Drug|Avotermin|Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding
16253372|NCT00984503|Drug|Placebo|Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding
16253373|NCT00984503|Drug|Avotermin|Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1
16253374|NCT00984503|Drug|Placebo|Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1
16253375|NCT00984490|Drug|metformin hydrochloride|Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery
16253376|NCT00984490|Other|laboratory biomarker analysis|Blood and tissue collection to determine the in situ biologic effect of metformin
16253377|NCT00984477|Drug|AZD5122|A single dose of oral suspension
16253378|NCT00984477|Drug|Placebo|A single dose of oral suspension
16253379|NCT00984477|Drug|AZD5122|A single intravenous infusion
16253380|NCT00984464|Biological|REOLYSIN|3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1,2,3,4 and 5 of a 21-day cycle
16253381|NCT00984464|Drug|Carboplatin|6 AUC mg/ml min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
16253382|NCT00984464|Drug|Paclitaxel|200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
16253383|NCT00984451|Biological|Plasma collection following infection or vaccination with influenza A|High titer influenza A plasma collection for use as therapeutic plasma in influenza treatment studies.
16253384|NCT00984438|Drug|BCNU Wafer|Implantable during surgical resection into the tumor bed
16253385|NCT00984438|Drug|Irinotecan|IV every 2 weeks for up to one year
16253386|NCT00984438|Drug|Bevacizumab|IV every 2 weeks for up to one year
16253387|NCT00984425|Drug|Lapatinib and Sorafenib|Comparison of different dosages of two drug
16253388|NCT00984412|Procedure|Allogeneic hematopoietic stem-cell-transplantation|2 allogeneic BMTs 6 weeks apart
16253390|NCT00984386|Drug|Zesteem|Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
16253391|NCT00984386|Drug|Zesteem|Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
16253396|NCT00984347|Drug|Oxytocin|"For low risk group (women at deliveries 1-5):
~IV oxytocin 10IU/1000ml standard sol. starting at 2MU/MIN and augmenting 2MU every 20 min.
~For high risk group (grandmultiparas [6th delivery and up] or women with a previous cesarean section)
~IV oxytocin 5IU/1000ml standard sol. starting at 1MU/MIN augmenting 1MU every 20 MIN - in accordance with the department's protocol"
16253397|NCT00984347|Procedure|breast pump nipple stimulation|breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest
16253398|NCT00984334|Drug|Naloxone SR 5 mg capsules|
16253399|NCT00984334|Drug|Placebo|
16253400|NCT00984334|Drug|Naloxone SR 10 mg capsules|
16253401|NCT00984334|Drug|Naloxone SR 20mg capsules|
16253402|NCT00984334|Drug|Naloxone SR 2.5 mg capsules|
16253403|NCT00984321|Behavioral|group intervention and questionnaires|Group Session will be 90 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
16253404|NCT00984321|Behavioral|individual phone intervention and questionnaires|Individual phone sessions will be 45 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
16253405|NCT00984321|Behavioral|expressive writing (arm will not be include in the randomization)|"intervention facilitate reappraisal through the exploration of past life events and prior successful ways of coping. Preliminary studies examining the efficacy of this writing intervention have shown its' ability to introduce patients to a new and effective coping method that can be utilized during future stressful cancer and aging related events.67 In the sessions, Wwe will explore past life events and ways of coping through manualized writing sessions."
16253406|NCT00984308|Procedure|CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)|Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
16253407|NCT00984295|Biological|Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|A single 0.5 mL subcutaneous injection at Day 0
16253408|NCT00984295|Biological|Comparator: Tripedia|A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
16253409|NCT00984295|Biological|Comparator: Comvax|A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
16253410|NCT00984295|Biological|Comparator: Varivax|A single 0.5 mL subcutaneous injection at Day 0
16253411|NCT00984295|Biological|Comparator: M-M-R II|A single 0.5 mL subcutaneous injection at Day 0
16253412|NCT00984282|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
16253413|NCT00984282|Drug|Placebo|Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
16253414|NCT00984269|Procedure|Tourniquet Use|Patients undergoing hand/wrist surgery with or without a tourniquet
16253415|NCT00984256|Drug|Atovaquone Proguanil|Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.
16253416|NCT00984256|Other|Procedure - malaria challenge|2) Procedure- Malaria Challenge- Volunteers will be exposed to bites of infectious mosquitoes with the intention of causing malaria infection. Volunteers infected with malaria will undergo approved treatments for malaria.
16253417|NCT00984243|Procedure|PHOTODYNAMIC THERAPY (PDT)|"Photodynamic Procedure:
~Photofrin II will be injected at a dosage of 2 mm/Kg intravenously. Laser treatment will take place 40-50 hours later. An argon-dye or an excimer-dye laser tuned to 620-630 nm will be used.
~It is anticipated that a microlens fiber will be used in almost all cases, but a cylinder-diffusing fiber can be used to treat lesions in segmental bronchi if needed.
~Argon-dye laser: Power settings 200 milliwatt (mW) microlens and 400 mW for cylinder Excimer laser: 4 milliJoules (mJoules)/pulse at 30 hertz for the microlens
~Energy density:
~Argon-dye laser: 200-300 Joules/cm^2 Excimer-dye laser: 100-200 Joules/cm^2"
16253418|NCT00984230|Other|BSF|feeding amount according to individual baby need
16253419|NCT00984230|Other|BSF + Lactoferrin + Probiotics|feeding amount according to individual baby need
16253420|NCT00984230|Other|BSF + Lactoferrin + Probiotics + OS|feeding amount according to individual baby need
16253421|NCT00984217|Radiation|Radiation|Radiation 64-70Gy (2.0 Gy/day, 5 days/week)
16253422|NCT00984217|Drug|Panitumumab|2.5 mg/Kg IV, weekly during RT. 6-7 weeks
16253423|NCT00984204|Device|Therapy Cool Path Duo|All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
16253424|NCT00984191|Radiation|99mTc-MIBI SPECT-CT|99mTc-MIBI SPECT-CT for abnormal cervical lymph node
16253425|NCT00984178|Other|Granulocite Colony Stimulating Factor treatment (G-CSF)|G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days
16253426|NCT00984178|Other|Bone marrow mononuclear cells|Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration
16253427|NCT00984165|Procedure|Single fraction radiation|8-Gy fraction of radiation
16253428|NCT00984165|Biological|Donor Lymphocyte Infusion (DLI)|Unmanipulated Donor Lymphocyte Infusion
16253429|NCT00984165|Procedure|Apheresis|Donors will undergo a 5-liter apheresis procedure on a CS-3000 or equivalent machine.
16253430|NCT00984152|Drug|TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily|TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily
16253431|NCT00984152|Drug|TDF/FTC + Efavirenz (Atripla) Once-Daily|TDF/FTC + Efavirenz (Atripla) Once-Daily
16253432|NCT00984139|Biological|Engerix™-B Kinder|Intramuscular, one dose.
16253433|NCT00984126|Drug|turoctocog alfa|The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
16253434|NCT00984126|Drug|turoctocog alfa|Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
16253435|NCT00984113|Drug|Elinogrel|100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
16253436|NCT00984100|Procedure|NOTES Transvaginal Cholecystectomy|An operation to remove the gallbladder, but instead of removing it via an incision in the abdominal wall, will be removed using an endoscope inserted through an opening in the posterior vagina (which then enters the abdominal cavity).
16253437|NCT00984087|Device|TMS with Neurostar TMS Therapy System|20 sessions with 1680 pulses per session at 10 Hz with a 4-second pulse train, stimulation at 100% motor threshold,
16253438|NCT00984074|Procedure|blood-oxygen-level-dependent functional magnetic resonance imaging|
16253439|NCT00984074|Procedure|diffusion tensor imaging|
16253440|NCT00984074|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16253441|NCT00984074|Procedure|functional magnetic resonance imaging|
16253442|NCT00984074|Radiation|intensity-modulated radiation therapy|
16253443|NCT00984074|Radiation|radiation therapy treatment planning/simulation|
16253444|NCT00984061|Drug|colchicine|0.6mg tablet administered at 9am on Day 1
16253445|NCT00984061|Drug|clarithromycin|250 mg clarithromycin tablet taken on an outpatient basis twice daily at 8am and 8pm for 14 doses (starting with 8pm dose on Day 22 and concluding with 8am dose on Day 29)
16253446|NCT00984061|Drug|colchicine|0.6 mg tablet administered at 9am on Day 29
16253447|NCT00984048|Other|Needle core biopsies of liver metastasis|No investigational products will be administered to subjects as part of this translational research study. A first-line chemotherapy regimen consisting of FOLFOX, XELOX or FOLFIRI +/- bevacizumab will be administered as per the standard of care at each treating institution. Needle core biopsies of liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.
16253448|NCT00984035|Other|urine samples (biomarkers)|Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
16253449|NCT00984035|Other|blood samples (biomarkers)|blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
16253450|NCT00984035|Other|blood sample (DNA)|Blood sample collected for DNA analysis at anytime while on-study.
16253451|NCT00984022|Device|Type of dressing - Iodoform|Dressing for packing a cutaneous abscess
16253452|NCT00984022|Device|Type of dressing - Aquacel|Aquacel dressing
16253453|NCT00984009|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone at 7:15 a.m. on Day 1
16253454|NCT00984009|Other|Grapefruit Juice|240 mL of grapefruit juice ingested twice daily at 7:15 a.m. and 7:15 p.m. on Days 15 to 18.
16253455|NCT00984009|Drug|Colchicine|A single dose of 0.6 mg colchicine administered with grapefruit juice at 7:15 a.m. on Day 18 after an overnight fast of at least 10 hours.
16253456|NCT00983996|Drug|Alendronate Sodium Tablets, 10 mg|10 mg, single-dose fasting
16253457|NCT00983996|Drug|Fosamax Tablets, 10 mg|10 mg, single-dose fasting
16253458|NCT00983983|Dietary Supplement|Oxepa|Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
16253459|NCT00983983|Dietary Supplement|Jevity 1.5|Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
16253460|NCT00983983|Dietary Supplement|Jevity 1.0|Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
16253461|NCT00983970|Behavioral|Interactive video game cycling|"Participants were required to exercise on a Gamebike® (Cat Eye Electronics Ltd, Boulder Col.) interactive video gaming system that was interfaced with a Sony Play Station 2® (Sony computer Entertainment America Inc. Foster, City, CA) and a 42 flat screen television monitor. The Gamebike® has a handlebar mounted game controller allowing the participant to play most Sony Playstation 2- race-based video games. The Gamebike® reads the participant's speed by cycling cadence and the faster the individual pedalled, the faster they moved in the virtual world on screen. Participants were told that they could exercise at any intensity and duration they desired. Participants were asked to come to the lab for two sessions per week for 60 minutes for 10 weeks. Although participants were required to stay in the lab for 60 minutes, they could take breaks or stop when they wanted, and reading materials were available for those who did not or could not cycle for the full 60 minute session."
16253462|NCT00983970|Behavioral|Cycling to Music|Each participant exercised twice weekly for 10 weeks on the Gamebike® but the games and controls were turned off. The Gamebike® was used by both groups to control for any differences between two cycle ergometers such as comfort or usability. However, participants were allowed to listen to music of their choice via radio, CD or personal music device. We incorporated music into the control condition because most youth and young adults exercise to music and this provides a more stringent test of the Gamebike® while improving the ecological validity of the research design. We also wanted to minimize drop-out and felt that expecting overweight/obese adolescents, who often report disliking aerobic exercise, to bike in a lab with no form of distraction would create a less than desirable exercise environment and result in high drop-out rates.
16253463|NCT00983957|Drug|BMS-790052|Tablets, Oral, 60 mg, once daily, 10 days
16253464|NCT00983957|Drug|Ortho Tri-Cyclen®|Tablets, Oral, once daily, 78 days
16253465|NCT00983944|Biological|bleomycin sulfate|Given IV
16253466|NCT00983944|Biological|rituximab|Given IV
16253467|NCT00983944|Drug|EPOCH regimen|Given IV or orally
16253468|NCT00983944|Drug|cyclophosphamide|Given IV or orally
16253469|NCT00983944|Drug|doxorubicin hydrochloride|Given IV or orally
16253470|NCT00983944|Drug|etoposide|Given IV or orally
16253473|NCT00983931|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone at 7:15 a.m. on Day 1 after an overnight fast of at least 10 hours.
16253474|NCT00983931|Drug|Cyclosporine|A single dose of 100 mg cyclosporine administered with colchicine at 7:15 a.m. on Day 15 after an overnight fast of at least 10 hours.
16253475|NCT00983931|Drug|Colchicine|A single dose of 0.6 mg colchicine administered with cyclosporine at 7:15 a.m. on Day 15 after an overnight fast of at least 10 hours.
16253476|NCT00983918|Drug|Desflurane|Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
16253477|NCT00983918|Drug|Sevoflurane|Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
16253478|NCT00983918|Drug|Isoflurane|Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
16253479|NCT00983918|Drug|Propofol|Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion
16253480|NCT00983905|Drug|Theophylline|single doses of 300 mg (80 mg/15 ml elixer) administered alone at 7:45 am on Day 1 and then along with colchicine at 7:45 am on Day 19
16253481|NCT00983905|Drug|Colchicine|one 0.6 mg tablet twice daily at 7:45 am and 7:45 pm on Days 5 to 19
16253482|NCT00983892|Behavioral|Caregiver website|Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
16253483|NCT00983866|Behavioral|Tailored Telephone Counseling|The intervention is comprised of a letter introducing patients to the idea of participating in a clinical trial as a possible treatment option, followed by a telephone call by a nurse educator who describes the clinical trials process and answers any questions patients may have. The nurse educators will use a tailored counseling protocol that will enable them to conduct an assessment of patients' understanding about and interest in clinical trials and tailor messages according to patient health literacy and language. The protocol will consist of both proactive and reactive counseling. The nurse educator will have a general list of topics to cover but will tailor the discussion and information provided to individual patients' questions and desire for particular types of information.
16253484|NCT00983853|Drug|telaprevir or matching placebo|Tablet, Oral, 750 mg, q8h, 12 weeks
16253485|NCT00983853|Drug|telaprevir or matching placebo|Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
16253486|NCT00983853|Biological|peginterferon alfa-2a|Subcutaneous injection, 180 μg, once weekly, 48 weeks
16253487|NCT00983853|Drug|ribavirin (fixed dose)|Tablet, Oral, 800 mg, b.i.d., 48 weeks
16253488|NCT00983853|Drug|ribavirin (weight-based dose)|Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
16253489|NCT00983840|Other|Family Eats|8-session web-based program on healthy eating for African American families
16253490|NCT00983827|Device|Aquatic treadmill training|HydroWorx aquatic therapy pool with an underwater, integrated and adjustable speed treadmill
16253491|NCT00983814|Drug|Droxidopa+Carbidopa|Droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) in combination with carbidopa (25mg or 50mg TID, provided as oral capsules taken TID from Baseline to end of Week 8
16253492|NCT00983814|Drug|Placebo|Placebo matched oral capsules taken TID from Baseline to end of Week 8
16253493|NCT00983801|Drug|Ixabepilone|Vial, Injection, Intravenous (IV), 40 mg/m^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.
16253494|NCT00983788|Drug|Bezafibrate|3 x 200 mg/ day
16253495|NCT00983788|Other|Placebo|Placebo
16253496|NCT00983775|Device|jet injector (SQ pen/Novopen III)|The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
16253497|NCT00983775|Device|jet injector (SQ pen/Novopen III)|The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
16253498|NCT00983749|Device|Full-pressure ECP|A one-hour treatment of ECP at full pressure, which will be applied in a tiered, dose-escalating manner, starting at 200mmHg and increasing up to 300mmHg based on assessments made.
16253499|NCT00983749|Device|Sham-pressure ECP|A one-hour treatment of ECP at an inactive pressure, which will be applied at 75mmHg and kept there for the hour while assessments are made.
16253500|NCT00983736|Drug|Tramadol Hydrochloride|"89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours).
~Subject will take the study drug for about 27 weeks."
16253501|NCT00983736|Drug|Placebo|"89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours).
~Subject will take the study drug for about 27 weeks."
16253502|NCT00983710|Behavioral|PC-PEP - Prostate Cancer Patient Education Program|Men in the intervention group will receive a new patient education intervention to help them manage side-effects related to treatment for localized prostate cancer. The intervention will be delivered by phone and by mail and is targeted to me with low health literacy. The intervention consists of written materials, audio materials, and telephone-based problem-solving education.
16253503|NCT00983710|Behavioral|Usual care|Booklet on coping with localized prostate cancer
16253504|NCT00983697|Procedure|therapeutic conventional surgery|
16253505|NCT00983697|Radiation|fludeoxyglucose F 18|
16253506|NCT00983684|Device|Intrabeam|A dose of 20 Gy at the surface of the applicator or 6 Gy at 1cm (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 30 minutes, depending on the size of the applicator.
16253542|NCT00983424|Drug|Cyclosporins|dose escalation, administered orally twice a day
16253543|NCT00983424|Drug|nab-paclitaxel|100 mg/m2 IV days 1, 8 and 15
16253507|NCT00983684|Radiation|Post-operative radiotherapy|All patients randomised to receive conventional radiotherapy within this trial should be treated in accordance with a pre-specified policy. Dosage should only be applied to the breast; axillary, supra-clavicular and internal mammary nodes should not generally be irradiated by discrete fields.
16253508|NCT00983658|Drug|huMAb OX40L|Intravenous repeating dose
16253509|NCT00983658|Drug|placebo|Intravenous repeating dose
16253510|NCT00983645|Drug|Prograf|Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
16253511|NCT00983645|Drug|Neoral|Cyclosporine (Neoral) starting dose 3mg/kg PO BID
16253512|NCT00983632|Procedure|Selective vagus nerve stimulation|"Stimulus will be combination of quasi-trapezoidal cathodic and rectangular anodic current pulses. Precisely, the resulting current, biphasic and charge balanced combination will be composed of a quasi-trapezoidal cathodic phase with a square leading edge with different intensity ic , a plateau tc of 300 μs, and exponentially decaying phase texp of 500 μs, followed by a wide rectangular anodic phase ta of allow current magnitude ia. Anodic phase ia will be one-tenth of the magnitude in the cathodic phase. However, the width of the anodic phase ta will be dependent upon the charge injected in the cathodic phase: the greater the charge, the wider the anodic phase.
~For details see detailed study description"
16253513|NCT00983632|Device|selective vagus nerve stimulation|electrical vagus stimulation
16253514|NCT00983619|Drug|MEDI-551|MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.
16253515|NCT00983619|Drug|Rituximab|Rituximab will be administered IV on Days 1, 8, 15, and 22 (28- day cycle). The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent.
16253516|NCT00983593|Behavioral|Mind-Body Bridging|16 weeks of weekly Mind-Body Bridging group treatment lasting 60-90 minutes per session.
16253517|NCT00983580|Drug|Aspirin|Given PO
16253518|NCT00983580|Drug|Eflornithine|Given PO
16253519|NCT00983580|Other|Laboratory Biomarker Analysis|Correlative study
16253520|NCT00983580|Other|Placebo|Given PO
16253521|NCT00983580|Other|Telephone-Based Intervention|Ancillary studies
16253522|NCT00983567|Other|teen web|Min web
16253523|NCT00983554|Drug|Anastrazole|Arimidex 1mg daily
16253524|NCT00983554|Drug|Testosterone|Testim 10g daily
16253525|NCT00983554|Drug|Dutasteride|Avodart 2.5mg daily
16253526|NCT00983554|Drug|GnRH antagonist|Acyline 300 µg/kg subcutaneous injections every 2 weeks
16253527|NCT00983541|Drug|Fluorouracil (5-FU)|5-FU Injection,USP (GeneraMedix Inc.) is effective in palliative management of carcinoma (colon, rectum, breast, stomach, pancreas) FDA approved in 1962-NDA (New Drug Application)012209. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy
16253528|NCT00983541|Radiation|Brachytherapy or SBRT (Stereotactic body radiation therapy)|Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).
16253529|NCT00983541|Drug|Gemcitabine|"Pancreatic:Indicated as first line treatment for patients with locally advanced (nonresectable Stage II or III) or metastatic(Stage IV) pancreatic adenocarcinoma.
~Ovarian:Gemzar with carboplatin is indicated for treatment of patients with advanced ovarian cancer relapsed 6 months after plat-based therapy.
~Breast:Gemzar with paclitaxel is indicated for first line treatment of patients with metastatic breast cancer after failed anthracycline-containing adjuvant chemotherapy, unless anthracyclines.
~Non-small cell lung cancer(NSCLC):Gemzar is indicated with cisplatin for first line treatment of patients with inoperable, local advanced (Stage IIIA/IIIB), metastatic (Stage IV) NSCLC."
16253530|NCT00983528|Biological|Alemtuzumab|3mg day 1,10mg day 2, 30mg day 3, 30mg day 5, 30mg day 8, then three times per calendar week thereafter for a total 12- 30mg doses
16253531|NCT00983528|Drug|Clofarabine|"Dose Escalation
~Cycle 1 (30 days or until alemtuzumab completed) Clofarabine 10,20,30 or 40 mg/m2 days 5-9
~Cycle 2 and subsequent cycles (administered no more frequently than every 28 days) 10,20,30 or 40 mg/m2 days 1-5"
16253532|NCT00983515|Drug|Colchicine|A single dose of colchicine 0.6 mg administered alone at 7:00 a.m. on Day 1 after an overnight fast of at least 10 hours.
16253533|NCT00983515|Drug|Ritonavir|One 100 mg ritonavir capsule administered twice daily at 7:00 a.m. and 7:00 p.m. on Days 15 to 18 without regard to meals, then along with colchicine at 7:00 a.m. on Day 19 after an overnight fast of at least 10 hours; final dose of 100 mg ritonavir administered at 7:00 p.m. on Day 19
16253534|NCT00983515|Drug|Colchicine|A single dose of colchicine 0.6 mg administered along with ritonavir at 7:00 a.m. on Day 19
16253535|NCT00983489|Behavioral|video demonstration|video will be shown to mothers
16253536|NCT00983489|Behavioral|counselling|breast feeding counselling
16253537|NCT00983476|Behavioral|in-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
16253538|NCT00983476|Behavioral|web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
16253539|NCT00983450|Other|watching a normal walking clip|the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
16253540|NCT00983450|Other|watching walk backward clip|The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
16253541|NCT00983437|Drug|Armodafinil|
16253582|NCT00983203|Other|Soothe XP Lubricant Eye Drops|1 drop OU
16253544|NCT00983411|Other|Non intentional leaks during non invasive ventilation|During NIV sessions (in awake state for both the 10 healthy and the 10 OHS subjects and during sleep only for the OHS subjects), the investigators will create several levels of non intentional leaks in a random order
16253551|NCT00983385|Drug|Tapentadol PR|Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed a dose of 500 mg of Tapentadol per day.
16253552|NCT00983385|Other|Observation period|Eligibility assessment period to characterize the baseline over a one week period (week -1). Participants continued their previous treatment prior to allocation to tapentadol, if eligible.
16253553|NCT00983385|Drug|Tapentadol PR|Maintenance Period: In this period participants continued Tapentadol Prolonged Release (PR) on the dose established in the Titration and Optimal Dose Period. Tapentadol IR participants were not permitted to exceed a total daily tapentadol dose of 500 mg.
16253554|NCT00983372|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone at 7:15 am on Day 1 after an overnight fast of at least 10 hours.
16253555|NCT00983372|Drug|Diltiazem ER|One 240 mg diltiazem ER capsule administered daily at 7:15 am on Days 15 to 21.
16253556|NCT00983372|Drug|Colchicine|A single dose of 0.6 mg colchicine administered along with diltiazem ER at 7:15 am on Day 21 after an overnight fast of at least 10 hours.
16253557|NCT00983359|Radiation|Radiation Therapy|Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
16253558|NCT00983346|Drug|Bortezomib|"Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.
~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
16253559|NCT00983333|Device|Time to Talk CARDIO website|This interactive web-based training device involves the completion of a brief survey regarding communication experiences between patients and health care professionals. The pattern of responses to the survey generates a personalized set of short instructional videos which demonstrate effective communication skills.
16253560|NCT00983320|Drug|quetiapine|flexible dosage (50 to 300 mg)
16253561|NCT00983320|Drug|placebo|placebo
16253562|NCT00983307|Drug|Erlotinib|Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
16253563|NCT00983307|Radiation|Hypofractionated Radiotherapy|Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
16253564|NCT00983294|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone at 7:30 am on Day 1
16253565|NCT00983294|Drug|Azithromycin|Two 250 mg azithromycin tablets administered at 7:30 am on Day 15, then one 250 mg tablet administered daily at 7:30 am on Days 16 to 19.
16253566|NCT00983294|Drug|Colchicine|A single dose of 0.6 mg colchicine administered with azithromycin at 7:30 am on Day 19.
16253567|NCT00983281|Drug|Hextend|IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.
16253568|NCT00983268|Drug|capecitabine|1000 mg taken by mouth on the days of radiation only.
16253569|NCT00983268|Drug|vorinostat|"Vorinostat will be given by mouth on the day of radiation and then Monday-Friday for two weeks after radiation in these 4 possible doses:
~Vorinostat,at 100 mg
~Vorinostat,at 200 mg
~Vorinostat, at 300 mg
~Vorinostat, at 400 mg"
16253570|NCT00983268|Radiation|Radiotherapy|High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.
16253571|NCT00983268|Procedure|Surgery to remove tumor|Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.
16253572|NCT00983255|Drug|TR-701 FA for injection, 200 mg/vial|TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
16253573|NCT00983255|Drug|TR-701 FA tablets|TR-701 FA will be given once orally as a 200 mg tablet in Part C.
16253574|NCT00983242|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone at 8am on Day 1 after an overnight fast of at least 10 hours.
16253575|NCT00983242|Drug|Verapamil HCl ER|One 240 mg verapamil HCl ER tablet taken at 8am on Days 15-18 without regard to meals and along with colchicine at 8am on Day 19 after an overnight fast of at least 10 hours.
16253576|NCT00983242|Drug|Colchicine|A single dose of 0.6 mg colchicine administered along with verapamil HCL ER at 8 am on Day 19 after an overnight fast of at least 10 hours.
16253577|NCT00983229|Procedure|Tracheal intubation|Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
16253578|NCT00983216|Drug|Colchicine|A single dose of colchicine 0.6 mg administered alone at 7:30 a.m. on Day 1.
16253579|NCT00983216|Drug|Ketoconazole|one 200 mg Ketoconazole tablet administered twice daily at 7:15 a.m. and 7:15 p.m. on Days 15-18 without regard to meals, then along with colchicine at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours; final dose of 200 mg administered at 7:15 p.m. on Day 19
16253580|NCT00983216|Drug|Colchicine|A single dose of colchicine 0.6 mg administered along with ketoconazole at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours
16253581|NCT00983203|Other|FID 114657 ORB Preserved Ocular Emulsion|1 drop OU
16253583|NCT00983190|Device|Left Ventricular Assist Device (HeartMate II)|The HM II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via rigid inlet cannulae and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastamosis. Power and control of the pump are delivered through a percutaneous cable from pump to the belt-worn System Controller. The System Controller will receive power from the Power Base Unit (PBU), or two battery modules that may be worn in shoulder holsters or on the belt
16253584|NCT00983177|Drug|Colchicine|0.5 mg twice daily for 4 months
16253585|NCT00983177|Drug|lactose|lactose capsules twice daily
16253586|NCT00983164|Dietary Supplement|Antioxidant Supplementation|antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
16253587|NCT00983151|Drug|Tramadol Hydrochloride & Placebo|89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours) Subject will take the study drug for about 27 weeks
16253588|NCT00983138|Drug|recombinant asparaginase|10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy
16253589|NCT00983125|Drug|Clonidine|"Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.
~To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour."
16253590|NCT00983112|Drug|Human Fibrinogen and human thrombin (Evicel)|Product to be applied intraoperatively. No further administration will take place after this.
16253591|NCT00983112|Drug|Sodium Chlorure (Physiological saline)|Sterile concentration, local use.
16253592|NCT00983099|Drug|Neramexane|single and multiple dose, tablets, oral
16253593|NCT00983086|Drug|Flavanones of orange juice|The main objective of this study is to evaluate, in healthy volunteers with young children (50 and 65) and slightly overweight according to their usual diet, the effects of single dose (in postprandial period) and made repeated orange juice or orange flavanones purified on vascular function. The selection criteria for age and weight should, within a healthy population to select individuals who exhibit cardiovascular risk factors, and thus for which it should be a priori easier to identify a beneficial effect of dietary factors on the parameters associated with cardiovascular risk.
16253594|NCT00983073|Drug|Tapentadol|"Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day.
~Maintenance Period: Participants continuing on the dose established in the previous period."
16253595|NCT00983060|Drug|NIM811|BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
16253596|NCT00983060|Drug|Placebo BID + SOC|Placebo BID + SOC (PEG IFN and RBV)
16253597|NCT00983047|Drug|Nimotuzumab and Docetaxel|"The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD. No more than 4 cycles chemotherapy was given.
~Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity."
16253598|NCT00983034|Drug|lansoprazole, amoxicillin, clarithromycin|lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days
16253599|NCT00983021|Drug|insulin degludec/liraglutide|Single, simultaneous dose of NN9068, injected s.c. (under the skin)
16253600|NCT00983021|Drug|insulin degludec|Single, simultaneous dose of NN1250, injected s.c. (under the skin)
16253601|NCT00983021|Drug|liraglutide|Single, simultaneous dose of NN2211, injected s.c. (under the skin)
16253602|NCT00983021|Drug|placebo|Single, simultaneous dose of placebo, injected s.c. (under the skin)
16253603|NCT00983008|Behavioral|Protected time and Dedicated time|On Sunday through Thursday nights medical intensive care unit interns will have a 5 hour protected period from 2 to 7 am. During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients. The four hours between 2 and 6 am are entirely protected. 6 AM to 7 AM is dedicated time during which the interns will be expected to start pre-rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties. On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shifts.
16253604|NCT00982995|Drug|Palonosetron|Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
16253605|NCT00982982|Drug|THC and Iomazenil|"Iomazenil: 3.7 μg/kg intravenously over 10 minutes
~Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or joint. It is administered intravenously for 10 minutes."
16253606|NCT00982982|Drug|Placebo (control)|Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
16253607|NCT00982930|Drug|Tobramycin inhalation powder|Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.
16253608|NCT00982917|Behavioral|Stamp-in-Safety Curriculum|30 minute curriculum on playground safety
16253609|NCT00982917|Behavioral|Stamp-in-Safety curriculum|30 minute lesson on playground supervision
16253610|NCT00982904|Drug|Fexinidazole/Placebo|
16253611|NCT00982891|Drug|Opioid (morphine sulphate) in low dose|individualized titration
16253612|NCT00982878|Drug|Maraviroc|150mg twice daily
16253613|NCT00982865|Drug|MSC1936369B|
16253614|NCT00982865|Drug|MSC1936369B|
16253615|NCT00982865|Drug|MSC1936369B|
16253616|NCT00982865|Drug|MSC1936369B|
16253617|NCT00982839|Procedure|Syringe Conditioning|A syringe will be used to inflate the balloon at the end of the probe which is inside of the rectum.
16253618|NCT00982839|Procedure|Barostat Conditioning|A barostat machine will be used to inflate the balloon at the end of the probe which is inside of the rectum.
16253619|NCT00982826|Drug|ABT-072|See Arms information for a detailed description.
16253620|NCT00982826|Drug|Placebo|See Arms information for a detailed description.
16253621|NCT00982813|Other|Periodontal screening|"Periodontal screening in all patients giving birth between 24 and 37 gestational weeks.
~Bacteriological sampling in the periodontal pocketing. Search for specific cytokines in the periodontal pocketing. Professional prophylaxis and oral hygiene instruction."
16253622|NCT00982800|Drug|Gabapentin|200mg 3x/day for 3 days (9 doses total)
16253623|NCT00982800|Drug|Placebo Sugar Pill|
16253624|NCT00982787|Drug|Botanical extract from Passiflora incarnata|"Dosage form: Liquid Passiflora extract
~Dosage: 10ml (equivalent of 2.2 g of dried Passiflora)
~Frequency: Once/Twice a day
~Duration: 11 week intervention period"
16253625|NCT00982774|Biological|LEISH-F2 + MPL-SE vaccine|LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart
16253626|NCT00982748|Behavioral|Pranayama (Yoga Breathing) Techniques|1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.
16253627|NCT00982722|Drug|cholecalciferol and calcium carbonate|cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
16253628|NCT00982722|Drug|calcium carbonate|calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
16253629|NCT00982709|Behavioral|Aerobic vs. Agility Training|High Intensity 4x's per week for 4 weeks with a physical therapist.
16253630|NCT00982696|Biological|Opioid Growth Factor|250ug per kilogram weekly IV infusions
16253631|NCT00982657|Drug|CVX-060 + sunitinib|CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
16253632|NCT00982657|Drug|CVX-060 + sunitinib|CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
16253633|NCT00982657|Drug|CVX-060 + sunitinib|CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
16253634|NCT00982657|Drug|CVX-060 + sunitinib|CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
16253635|NCT00982657|Drug|CVX-060 + sunitinib|CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
16253636|NCT00982657|Drug|Sunitinib|50 mg sunitinib daily (4 out of 6 weeks)
16253637|NCT00982644|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16253638|NCT00982644|Drug|insulin glargine|Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16253639|NCT00982631|Drug|Temsirolimus/PLD|This is a dose escalation study. Patients will start with temsirolimus iv once weekly. After 2 weeks, PLD therapy is added. From then on, PLD is repeated every 4 weeks. One cycle is 28 days. The DLT period is also defined within the first 28 days of combination therapy (thus the first 6 weeks of study participation). The first dose level (DL) is DL 1. Depending on toxicity, intermediate dose levels can be added. If no MTD is found in the sixth cohort, this dose level will be considered as the recommended dose (RD), being the optimal dose for both drugs in this combination. At the MTD dose level, the dose level will be expanded to a total of 12 patients.
16253640|NCT00982618|Drug|Lidocaine|1% Lidocaine 1mg/kg/hr IV drip x 48hr
16253641|NCT00982618|Procedure|Epidural Block|0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
16253642|NCT00982618|Drug|PCA Morphine|PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
16253643|NCT00982605|Procedure|EBUS_TBNA|EBUS during bronchoscopy
16253644|NCT00982592|Drug|oxaliplatin|Given IV
16253645|NCT00982592|Drug|leucovorin calcium|Given IV
16253646|NCT00982592|Drug|fluorouracil|Given IV
16253647|NCT00982592|Other|placebo|Given PO
16253648|NCT00982592|Drug|vismodegib|Given PO
16253649|NCT00982592|Other|laboratory biomarker analysis|Correlative studies
16253650|NCT00982579|Biological|MVA.HIVA|1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
16253651|NCT00982566|Drug|ABT-263|Part 1: Single (oral) dose of 250 mg of Formulation B1 vs. single (oral) dose of 250 mg of Formulation A
16253652|NCT00982566|Drug|ABT-263|Part 1 continued. Single (oral) dose of 250 mg of Formulation B2 vs. single (oral) dose of 250 mg of Formulation A
16253653|NCT00982566|Drug|ABT-263|Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A
16253654|NCT00982566|Drug|ABT-263|Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A
16253655|NCT00982553|Drug|Ribavirin|800mg once daily
16253656|NCT00982553|Drug|Raltegravir|400mg twice daily
16253657|NCT00982540|Drug|caspofungin as preemptive antifungal therapy|70 mg day 1 followed by 50 mg/day IV
16253658|NCT00982527|Drug|Placebo|Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
16253659|NCT00982527|Drug|Fenoldopam|Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.
16253660|NCT00982501|Drug|WS® 1442 900 mg/d|
16253661|NCT00982501|Drug|WS® 1442 1800 mg/d|
16253662|NCT00982501|Behavioral|Nordic walking training 2 x 30 min/week|
16253663|NCT00982501|Behavioral|Nordic walking training 4x45 min/week|
16253664|NCT00982488|Drug|Dasatinib|Dasatinib was supplied as 20- and 50-mg tablets.
16253665|NCT00982488|Drug|Imatinib|Imatinib was supplied as 100- and 400-mg tablets.
16253666|NCT00982475|Procedure|Pulmonary vein isolation with radiofrequency current|Pulmonary vein isolation with radiofrequency current
16253667|NCT00982462|Dietary Supplement|Docosahexaenoic acid (DHA) and arachidonic acid (ARA)|Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.
16253668|NCT00982462|Dietary Supplement|Corn oil placebo|Micro-encapsulated powder containing corn oil as the placebo.
16253669|NCT00982449|Other|FIAU-PET-CT-2|1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU
16253670|NCT00982449|Other|FIAU-PET-CT-4|1-3 days after any chemotherapy that may activate viral TK, 4 mCi, rather than 2 mCi, of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT
16253671|NCT00982436|Drug|Docetaxel/cisplatin|Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles
16253672|NCT00982436|Radiation|Radiotherapy|70 Gy in 35 fractions to gross tumor and lymph node metastases
16253673|NCT00982436|Drug|Carboplatin|Carboplatin AUC 1.5 intravenous weekly during radiotherapy
16253674|NCT00982423|Drug|Furosemide|Subjects received their clinically prescribed dose of furosemide for a 3 week stabilization period, then were assessed for cardiorenal and humoral function. Subjects then had a 50% reduction of the furosemide dose for a 3 week stabilization period, and were assessed for cardiorenal and humoral function again.
16253675|NCT00982410|Behavioral|cognitive-behavioral treatment|cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
16253676|NCT00982410|Behavioral|educational supportive group|A control condition providing social support and education about pain and/or drug use.
16253677|NCT00982397|Device|Protecta VR-ICD|Protecta single-chamber implantable cardioverter defibrillators.
16253678|NCT00982397|Device|Protecta DR-ICD or CRT-D|Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
16253679|NCT00982384|Other|Disease management|Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients
16253680|NCT00982384|Other|Best care|Comprehensive care for COPD patients recommended in clinical guidelines
16253681|NCT00982358|Drug|Valsartan|
16253682|NCT00982358|Other|Placebo|
16253683|NCT00982345|Drug|quetiapine (Seroquel XR)|Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
16253684|NCT00982332|Drug|Betamethasone|betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
16253685|NCT00982332|Drug|isotonic sodium chloride solution (placebo)|4 ml intramuscular
16253686|NCT00982319|Drug|Broccoli sprout extract|100 µmols of sulforaphane (dissolvable)
16253687|NCT00982319|Drug|Mango juice|150 mL of mango juice
16253688|NCT00982306|Behavioral|Brief intervention|20 minute one to one counseling session
16253689|NCT00982293|Device|Resonator device|Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each.
16253690|NCT00982293|Device|Resonator device - sham|"Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be on"
16253691|NCT00982280|Drug|Tapentadol PR|"Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day.
~Maintenance Period: Participants continuing on the dose established in the previous period."
16253692|NCT00982267|Drug|SU014813|Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off
16253693|NCT00982254|Drug|Oral insulin|oral insulin capsule formulation (150 U insulin/200 mg 4-CNAB in one capsule); single dose administration of 300 U insulin (in two capsules) and of 150 U insulin (one capsule) on two separate dosing days.
16253694|NCT00982254|Drug|regular human insulin|subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.
16253695|NCT00982241|Dietary Supplement|water|drinking water / normal dietary fluids for oral intake
16253696|NCT00982228|Drug|insulin degludec|Injected subcutaneously once daily. Dose was individually adjusted.
16253697|NCT00982228|Drug|insulin glargine|Injected subcutaneously once daily. Dose individually adjusted.
16253698|NCT00982228|Drug|insulin aspart|Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
16253699|NCT00982215|Drug|Kinetics of plasma concentrations of paracetamol|Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
16253700|NCT00982215|Drug|Placebo|Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
16253701|NCT00982202|Drug|pioglitazone|15mg tablet daily, increase by one pill at one-week intervals based on reported tolerability; maintain best tolerated dose (1 to 3 tablets daily) for ~18months
16253702|NCT00982202|Drug|Placebo|1 to 3 tablets daily for ~18 months
16253703|NCT00982189|Drug|Pravastatin|Participants randomized to take pravastatin (active) or matching placebo pill once daily
16253704|NCT00982189|Drug|Lisinopril|Participants randomized to take lisinopril (active) or matching placebo pill once daily
16253705|NCT00982176|Other|Brain MRI and cerebral perfusion scintigraphy|"A standard neuropsychological assessment will be performed by a neuropsychologist. The daily life experience study will be performed. Questions will be asked to the patients by a pocket computer (Palm).
~MRI will be performed on a 3 Tesla research MRI. Two Tc-99m-HMPAO SPECT studies will be performed The second SPECT study will be performed after intravenous injection of acetazolamide."
16253706|NCT00982150|Drug|Talampanel|50mg capsules tid
16253707|NCT00982137|Biological|Live attenuated Japanese encephalitis virus; Yellow fever virus|ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.
16253708|NCT00982137|Biological|Yellow fever virus; Live attenuated Japanese encephalitis virus|STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.
16253709|NCT00982137|Biological|Live attenuated Japanese encephalitis virus; Yellow fever virus|ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.
16253710|NCT00982137|Biological|Live attenuated Japanese encephalitis virus; Yellow fever virus|Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
16253711|NCT00982124|Drug|Zoledronic Acid|Each patient is to receive an initial dose of zoledronic acid of 0.0125 mg per kg body weight, then subsequent doses of zoledronic acid at a dose of 0.025 mg per kg body weight once every 12 to 13 weeks for 104 weeks (total of 8 doses).
16253807|NCT00981513|Biological|Saline|One dose
16253715|NCT00982098|Procedure|BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises|After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
16253716|NCT00982072|Drug|tacrolimus|tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
16253717|NCT00982072|Drug|prednisolone|Prednisolone 1mg/kg maximum 60mg od
16253718|NCT00982059|Other|Colonoscopic examination|All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.
16253719|NCT00982046|Device|Opti-Free RepleniSH multi-purpose disinfecting solution|Contact lens solution CE-marked for intended use.
16253720|NCT00982046|Device|ReNu MultiPlus multi-purpose solution|Contact lens solution CE-marked for intended use.
16253721|NCT00982046|Device|Clear Care cleaning and disinfecting system|Contact lens care system CE-marked for intended use.
16253722|NCT00982046|Device|Senofilcon A contact lens (ACUVUE OASYS)|Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
16253723|NCT00982046|Device|Lotrafilcon B contact lens (AIR OPTIX AQUA)|Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
16253724|NCT00982046|Device|Comfilcon A contact lens (Biofinity)|Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
16253725|NCT00982033|Drug|aliskiren|aliskiren 300mg qd versus placebo for 24 weeks.
16253726|NCT00982033|Drug|placebo|placebo qd for 24 weeks
16253727|NCT00982020|Drug|Olanzapine|2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
16253728|NCT00982020|Behavioral|Standard behavioral weight intervention|One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.
16253729|NCT00982020|Behavioral|Intense behavioral weight intervention|Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.
16253730|NCT00982007|Drug|Ferric Carboxymaltose (FCM)|A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
16253731|NCT00982007|Drug|Ferrous Sulfate Tablets|325 mg Ferrous Sulfate tablets taken orally three times a day
16253732|NCT00982007|Drug|IV Iron (standard of care)|IV standard of care (other IV iron) per the Investigator's discretion
16253733|NCT00982007|Drug|Ferric Carboxymaltose (FCM)|A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
16253734|NCT00981994|Behavioral|Decision Support for ARI Management|Use of history and physical examination findings to estimate probability of pneumonia in patients with acute respiratory infections and thereby guide treatment decisions
16253735|NCT00981981|Dietary Supplement|Wheat bran|21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
16253736|NCT00981981|Dietary Supplement|3g high MW|20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight
16253737|NCT00981981|Dietary Supplement|4g medium MW|28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
16253738|NCT00981981|Dietary Supplement|3g medium MW|21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
16253739|NCT00981981|Dietary Supplement|4g low MW|28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
16253740|NCT00981968|Drug|Sitaxentan sodium/Placebo|100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
16253741|NCT00981968|Drug|Sitaxentan sodium/Placebo|100 mg and 200 mg, tablet, single oral dose
16253742|NCT00981955|Dietary Supplement|Caffeine and L-theanine|Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
16253743|NCT00981942|Drug|Imatinib mesylate (Glivec)|400 mg, one tablet daily for 12 or 24 weeks
16253744|NCT00981929|Drug|Tramadol|50 mg single oral dose
16253745|NCT00981929|Drug|Omeprazole, losartan, caffeine|20 mg omeprazole 25 mg losartan 200 mg caffeine
16253746|NCT00981929|Drug|Tramadol, omeprazole, losartan, caffeine|50 mg tramadol 20 mg omeprazole 25 mg losartan 200 mg caffeine
16253747|NCT00981903|Drug|Tinzaparin sodium|Subcutaneous injection 175 U/Kg/day
16253748|NCT00981890|Drug|Sunitinib|Sunitinib is a tablet that is taken by mouth every day. Patients will be treated with Sunitinib alone for 7 days. On the seventh day of taking the drug they will be given SRS. Sunitinib will continue for seven days per week after SRS, and depending on how far along the study is when patients join, they may continue taking the drug for up to 13 weeks after SRS.
16253749|NCT00981877|Drug|GB (Florestor)|S. Boulardii preparation of 1 gram twice daily for 5 days
16253750|NCT00981877|Drug|GRALB|mixed probiotic preparation 1 gram twice daily for 5 days.
16253751|NCT00981877|Drug|GC (placebo)|Placebo 1 gram twice daily for 5 days.
16253752|NCT00981864|Radiation|Concurrent Boost RT|Patient will receive radiation to the tumour bed concurrently with whole breast radiation instead of receiving this treatment sequentially, that is, whole breast RT first then followed by RT directly to the tumour bed.
16253753|NCT00981851|Drug|Tiotropium (Spiriva) + Salbutamol (Ventolin)|1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking
16253808|NCT00981500|Procedure|gastric bypass|Roux-en-Y gastric bypass
16253754|NCT00981851|Drug|placebo|1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking
16253755|NCT00981838|Drug|Rituximab|Rituximab (375 mg/m2) will be given as a single intravenous infusion after reconstitution in normal saline to a concentration of 1 mg/ml given though a 0.22 micron in line filter. The initial infusion rate will be 1 ml/kg/h and will be progressively increased up to 4 ml/kg/h according to drug tolerability. Pre-medication with steroids and/or antihistaminic agents will be done according to per-center's practice.Rituximab administration will be repeated in those patients > 5 B cells/mm3 in the peripheral blood on the day after first Rituximab administration.
16253756|NCT00981825|Drug|Fluoride|Whole mouth brushing for 7 days
16253757|NCT00981825|Drug|Triclosan/Fluoride|Brush whole mouth twice daily for 7 days
16253758|NCT00981812|Procedure|PEM Breast Biopsy|Breast biopsy using PEM guidance and Stereo Navigator software
16253759|NCT00981799|Drug|Nelarabine|Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
16253760|NCT00981799|Drug|Etoposide|100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
16253761|NCT00981799|Drug|Cyclophosphamide|Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
16253762|NCT00981799|Drug|Methotrexate|"Give between day 29 and 36 or when ANC>750 and PLTS>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.
~Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but <2 years of age 10 mg for patients age greater than or equal to 2, but <3 years of age 12 mg for patients greater than or equal to 3, but < 9 years of age 15 mg for patients greater than or equal to >9 years of age"
16253763|NCT00981799|Drug|Filgrastim|5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000/mm3 for two consecutive days.
16253764|NCT00981786|Drug|Brimonidine/timolol fixed combination drops added to travoprost|twice daily administration
16253765|NCT00981786|Drug|Brinzolamide/timolol fixed combination drops added to travoprost|twice daily dosing
16253766|NCT00981773|Drug|Maraviroc|Maraviroc 150 mg bid
16253767|NCT00981773|Drug|Maraviroc|maraviroc 150 mg bid switch 12 weeks later
16253768|NCT00981747|Drug|Sildenafil|Sildenafil 20mg three times per day for 3 months followed by a one month washout prior to next intervention.
16253769|NCT00981747|Drug|Losartan|Losartan 25mg two times a day for 3 months followed by a one month washout prior to next intervention.
16253770|NCT00981747|Drug|Sildenafil and Losartan|Sildenafil 20mg three times per day and Losartan 25mg two times per day followed by a one month washout prior to next intervention.
16253771|NCT00981747|Drug|Placebo Oral Tablet|Placebo pill three times per day for 3 months followed by a one month washout prior to next intervention.
16253772|NCT00981734|Other|Hiking|Three times by a week, thirty minutes, controlling heart frequency between fifty five per cent and seventy five per cent.
16253773|NCT00981721|Drug|cediranib (RECENTIN TM, AZD2171)|20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8
16253774|NCT00981708|Drug|Lenalidomide, Dexamethasone and Cyclophosphamide|"Lenalidomide capsules on days 1 to 21. the dose starts at 5 mg/day up to 25 mg/day.
~Dexamethasone tablets on days 1 to 4. Dose 20 mg per day.
~Cyclophosphamide tablets on days 1 to 10. The dose starts at 50 mg per day up to 100 mg per day.
~The cycle is to be repeated every 28 days (4 weeks)"
16253775|NCT00981695|Biological|MVA.HIVA|1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
16253776|NCT00981682|Drug|SER120|once a day treatment of nocturia
16253777|NCT00981669|Biological|rotavirus vaccine|3 doses with 6 weeks interval
16253778|NCT00981669|Biological|placebo|3 doses with 6 weeks interval
16253779|NCT00981656|Drug|cisplatin|Given IV
16253780|NCT00981656|Drug|fluorouracil|Given IV
16253781|NCT00981656|Drug|mitomycin C|Given IV
16253782|NCT00981643|Behavioral|Meditation instruction and practice|Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
16253783|NCT00981630|Biological|Live attenuated Japanese encephalitis virus|0.5 mL,Subcutaneous
16253784|NCT00981630|Biological|Live attenuated Japanese encephalitis virus|0.5 mL, Subcutaneous
16253785|NCT00981630|Biological|Live attenuated Japanese encephalitis virus|0.5 mL, Subcutaneous
16253786|NCT00981630|Biological|ChimeriVax™ diluent (Placebo)|0.5 mL, Subcutaneous
16253787|NCT00981617|Drug|ALKS33 (RDC-0313) (1 mg)|1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
16253788|NCT00981617|Drug|ALKS33 (RDC-0313) (2.5 mg)|2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
16253789|NCT00981617|Drug|ALKS33 (RDC-0313) (10 mg)|10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
16253790|NCT00981617|Drug|Placebo|Matching placebo taken once daily for 12 weeks
16253791|NCT00981604|Procedure|SILS|Single Incision Laparoscopic Cholecystectomy
16253792|NCT00981604|Procedure|Standard Laparoscopic Cholecystectomy|4 port technique
16253793|NCT00981591|Drug|Iloprost|Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes
16253794|NCT00981591|Drug|Placebo|Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
16253795|NCT00981578|Device|ExAblate 2100|Conformal Bone System
16253796|NCT00981565|Procedure|open carpal tunnel release|surgery to release the carpal tunnel
16253797|NCT00981565|Other|Night-cast|individual night time splinting
16253798|NCT00981552|Radiation|IMRT planning|
16253799|NCT00981552|Radiation|4-Field Radiation Planning|
16253800|NCT00981539|Procedure|enema|"pre operative rectal enema
~one adult bottle to be used rectally the night before surgery"
16253801|NCT00981526|Drug|Telmisartan|"Telmisartan 40mg/day for the first 2 weeks.
~Telmisartan 80mg/day for the next 10 weeks."
16253802|NCT00981526|Drug|Placebo|Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.
16253803|NCT00981526|Drug|Clozapine|Clozapine (plus telmisartan or placebo) for 12 weeks.
16253804|NCT00981526|Drug|Olanzapine|Olanzapine (plus telmisartan or placebo) for 12 weeks.
16253805|NCT00981513|Biological|Trivalent live attenuated seasonal influenza vaccine|One dose
16253806|NCT00981513|Biological|Monovalent live attenuated pandemic influenza vaccine|One dose
16253809|NCT00981500|Procedure|gastric banding|laparoscopic adjustable gastric banding
16253810|NCT00981500|Procedure|sleeve gastrectomy|vertical sleeve gastrectomy
16253811|NCT00981487|Drug|Ondansetron|24 mg one time
16253812|NCT00981487|Drug|Ondansetron|24 mg, on time in the am
16253813|NCT00981474|Drug|blood pressure maintenance based on cerebral blood flow autoregulation measurement|Blood pressure lowered or raised
16253814|NCT00981474|Device|Control group|Institutional standard of care.
16253815|NCT00981461|Device|HairMax LaserComb|Device application 3 times week, for 26 weeks
16253816|NCT00981461|Device|Control Device|Device application 3 times week, for 26 weeks
16253817|NCT00981448|Dietary Supplement|Zinc acetate|50mg of elemental zinc to be administered 2 times daily orally for 14 days.
16253818|NCT00981435|Drug|Prednisolone 1%|Prednisolone 1% to lasered eye 4 times/day for 4.5 days
16253819|NCT00981435|Drug|Ketorolac|Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days
16253820|NCT00981435|Drug|Artificial Tears|Artificial saline tears to lasered eye 4 times/day for 4.5 days
16253821|NCT00981409|Drug|Fondaparinux sodium|The dose of Fondaparinux will be determined based on a subject's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
16253822|NCT00981409|Drug|unfractionated heparin (UFH)|UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.
16253823|NCT00981396|Behavioral|EFT (Emotional Freedom Techniques)|EFT is a brief but efficacious stress-reduction intervention. It combines exposure, cognitive structuring, and somatic stimulation.
16253824|NCT00981396|Behavioral|CBT (Cognitive Behavioral Therapy)|CBT is a behavioral intervention that seeks to challenge and change negative client cognitions about events and life circumstances.
16253825|NCT00981383|Dietary Supplement|Omega-3 Fatty Acid Supplement|3 capsules (3x1g) fish oil-derived concentrated ethyl esters, providing 1.9 g omega-3 fatty acids (1.2 g EPA and 0.6 g DHA, with 0.1 g other omega-3 fatty acids)
16253826|NCT00981383|Other|Placebo|3 capsules (3x1g) of 50/50 soybean/corn oil blend containing less than 0.12 g of omega-3 fatty acids with negligible EPA and DHA
16253827|NCT00981370|Drug|deferasirox|Treatment starting dose of 20mg/kg/day based on subjects baseline LIC (liver iron concentration) and gradually escalate the dose to a maximum of 35 mg/kg/day based upon toxicity. Duration is up to a max of 12 months.
16253828|NCT00981357|Drug|PF-04457845|PF-04457845 4 mg tablet once daily / matched placebo
16253829|NCT00981357|Drug|PF-04457845|PF-04457845 4 mg tablet once daily / matched placebo
16253830|NCT00981357|Drug|Naproxen|Naproxen 500 mg tablet twice daily / matched placebo
16253831|NCT00981357|Drug|Naproxen|Naproxen 500 mg tablet twice daily / matched placebo
16253832|NCT00981344|Other|Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments|We are studying how wheeled mobility performance and the impact of device type on a group of community dwelling Veterans.
16253833|NCT00981331|Procedure|Subtalar joint manipulation|The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
16253834|NCT00981331|Procedure|Sham subtalar joint manipulation|The sham manipulation is conducted by placing the ankle in a non-manipulative position, and the operator simply engages the toggle board to simulate the audible noise of the toggle board dropping. No force or thrust is applied to the ankle.
16253835|NCT00981318|Drug|lopinavir/ritonavir plus maraviroc|lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
16253836|NCT00981305|Drug|Lactate-containing vaginal lubricant|vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
16253837|NCT00981305|Drug|Placebo vaginal lubricant|vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
16253838|NCT00981292|Dietary Supplement|EGCG|Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
16253839|NCT00981292|Dietary Supplement|Placebo|Pharmaceutical grade silica was utilized as placebo
16253840|NCT00981266|Device|Mentor Spectra/Becker 80 Breast Implant|The Mentor Smooth Spectra/Becker 80 Adjustable Breast Implant has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over a period of time via the fill tube by injecting saline through the injection dome. Once filled to the desired volume, the fill tube and injection dome are removed, and the prosthesis remains in position as a breast implant. Its purpose is to provide volume flexibility and projection adjustability.
16253841|NCT00981253|Behavioral|SMT-enhanced Cardiac Rehabilitation|Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.
16253842|NCT00981253|Behavioral|Standard Cardiac Rehabilitation|Supervised exercise, three times per week, for 12 weeks.
16253843|NCT00981240|Drug|SAR103168|"Pharmaceutical form: Concentrate for solution for infusion
~Route of administration: Intravenous infusion"
16253844|NCT00981227|Drug|Eslicarbazepine acetate|Scored tablets
16253845|NCT00981227|Drug|Placebo|oral route
16253846|NCT00981214|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule will be administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule will be allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
16253847|NCT00981201|Drug|Celecoxib|"Months 1-3:
~As of October, 2003, the starting dose for celecoxib will be 400 mg by mouth twice daily. (Note: Prior to October, 2003, the starting dose for celecoxib was 200 mg by mouth twice daily.)"
16253848|NCT00981201|Drug|Celecoxib|"Months 4-6:
~As of October, 2003, the starting dose for celecoxib will be 400 mg by mouth twice daily. (Note: Prior to October, 2003, the starting dose for celecoxib was 200 mg by mouth twice daily.)"
16253849|NCT00981201|Drug|Placebo|"Months 1-3:
~By mouth twice daily."
16253850|NCT00981201|Drug|Placebo|"Months 4-6:
~By mouth twice daily."
16253851|NCT00981175|Biological|Live attenuated Japanese encephalitis virus, then ChimeriVax diluent|ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
16253852|NCT00981175|Biological|ChimeriVax diluent, then Live attenuated Japanese encephalitis virus|ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
16253853|NCT00981162|Drug|sorafenib tosylate|Given PO
16253854|NCT00981162|Drug|everolimus|Given PO
16253855|NCT00981162|Other|laboratory biomarker analysis|Correlative study
16253856|NCT00981162|Other|pharmacogenomic studies|Correlative study
16253857|NCT00981162|Other|pharmacological study|Correlative study
16253858|NCT00981149|Drug|duloxetine|Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period
16253859|NCT00981149|Drug|Placebo|Placebo match duloxetine for 6 week period.
16253860|NCT00981136|Procedure|Single Incision Laparoscopic Appendectomy|A single incision through the umbilicus to remove the appendix
16253861|NCT00981136|Procedure|3 port laparoscopic appendectomy|Standard 3 port laparoscopic appendectomy with intracorporeal stapling
16253862|NCT00981110|Device|AQUAGEL Ag Hydrofiber Wound Dressing|Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure
16253863|NCT00981110|Device|Mepore Self-adhesive absorbent dressing|Standard dressing: medication performed as for frequency and duration according standard procedure
16253864|NCT00981097|Genetic|polymerase chain reaction|determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
16253865|NCT00981097|Other|laboratory biomarker analysis|determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
16253866|NCT00981084|Drug|armodafinil|Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.
16253867|NCT00981058|Biological|Necitumumab|"800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle.
~Continues until progressive disease, toxicity, noncompliance, or withdrawal."
16253868|NCT00981058|Drug|Gemcitabine|"1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
~Continues for a maximum of six cycles."
16253869|NCT00981058|Drug|Cisplatin|"75 mg/m2 IV on Day 1 of every 3 week cycle.
~Continues for a maximum of six cycles."
16253870|NCT00981045|Drug|Ferric Carboxymaltose (FCM)|2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
16253871|NCT00981045|Drug|Iron Sucrose (Venofer)|5 doses of 200 mg for a total cumulative dose of 1000 mg
16253872|NCT00981032|Behavioral|Pre-visit Summary|The intervention is a pre-visit summary given to the patient prior to their appointment. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use.
16253873|NCT00981032|Behavioral|Clinical Decision Sharing Tool|This intervention includes a pre-visit summary and a clinical decision sharing tool. Patients will receive a pre-visit summary prior to their appointment. They will also view a clinical decision sharing tool in conjunction with the physician in the office. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use. The clinical decision sharing tool informs the physician of the patient's heart attack or stroke risk and determines if the patient would benefit from aspirin use.
16253874|NCT00981006|Procedure|human cardiac stem cells|Single intramyocardial Injection of autologous hCSCs : 20 cites of infarcted myocardium Implantation of gelatin hydrogel sheet incorporating bFGF: 200 microgram. CABG surgery.
16253875|NCT00980980|Drug|Chlorhexidine bath and nasal mupirocin|The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
16253876|NCT00980967|Other|Study of predictive factors|Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients
16253877|NCT00980954|Drug|carboplatin|Given IV
16253878|NCT00980954|Drug|cisplatin|Given IV
16253879|NCT00980954|Drug|paclitaxel|Given IV
16253880|NCT00980941|Dietary Supplement|soup with or without starch|
16253881|NCT00980889|Device|Steel|ERCP procedure insertion of Metalic Steel Stent, Wallstent®
16253882|NCT00980889|Device|Nitinol|Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
16253883|NCT00980876|Drug|Cipro HC|Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
16253884|NCT00980876|Drug|Ciprofloxacin HCl and Hydrocortisone|Ciprofloxacin Hydrochloride and Hydrocortisone
16253885|NCT00980863|Behavioral|lifestyle intervention to increase physical activity|
16253886|NCT00980850|Biological|Baxter Novel Influenza A H1N1 Whole Virus Vaccine|Two 0.5 ml doses of vaccine given within 3 weeks interval
16253887|NCT00980850|Biological|GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine|Two 0.25 ml doses of vaccine given within 3 weeks interval
16253888|NCT00980824|Behavioral|Cognitive behavioural therapy|Six sessions brief CBT.
16253889|NCT00980824|Other|Standard treatment|Referral to NHS services appropriate to patient's needs
16253890|NCT00980798|Drug|OROS hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
16253891|NCT00980798|Drug|Placebo|placebo tablet once daily for 16 weeks
16253892|NCT00980785|Drug|Ramipril|Ramipril 5 mg/day
16253893|NCT00980785|Drug|Placebo|Matching Placebo
16253894|NCT00980759|Radiation|EFI|Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)
16253895|NCT00980759|Radiation|Pelvic RT|Only Pelvic Irradiation with chemotherapy(cisplatin)
16253896|NCT00980746|Drug|Eslicarbazepine acetate|Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
16253897|NCT00980746|Drug|Placebo|oral route
16253898|NCT00980733|Dietary Supplement|Fortified Yoghurt|The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
16253899|NCT00980733|Dietary Supplement|Yoghurt|Plain yoghurt same as in intervention group without fortification
16253900|NCT00980707|Drug|Inhaled corticosteroid (fluticasone)|inhaled fluticasone 220 ug/bid
16253901|NCT00980694|Dietary Supplement|ubiquinol|up to 600 mg per day, oral capsules for 8 weeks
16253902|NCT00980681|Drug|Dotarem|Each subject will receive one injection of Dotarem 0.2ml/kg
16253903|NCT00980681|Other|Time of Flight|Each subject will undergo a TOF MRA
16253904|NCT00980655|Biological|13vPnC|"0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5.
~Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose."
16253905|NCT00980655|Biological|23vPS|0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.
16253906|NCT00980642|Device|Draeger double-sensor|The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.
16253907|NCT00980642|Device|Esophageal stethoscope temperature sensor|Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.
16253908|NCT00980642|Device|Foley catheter temperature sensor|Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
16253909|NCT00980629|Drug|M516102|Twice a day
16253910|NCT00980629|Drug|placebo|Twice a day
16253911|NCT00980616|Drug|ropivacaine, physical serum and adrenalin|A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin
16253912|NCT00980603|Drug|docetaxel|docetaxel 75 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops
16253913|NCT00980603|Drug|docetaxel, cisplatin|docetaxel 60 mg/m2 and cisplatin 60 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops
16253914|NCT00980603|Drug|docetaxel, S-1|docetaxel 60 mg/m2 IV on day 1 and S-1 30 mg/m2 bid PO on days 1-14 of each 3 week cycle until progression or unacceptable toxicity develops
16253915|NCT00980590|Device|Airway Scope|Tracheal intubation by Airway Scope
16253916|NCT00980590|Device|Macintosh Laryngoscope|Tracheal intubation by Macintosh Laryngoscope
16253917|NCT00980577|Device|NUUS|Sonosite Micro Maxx
16253918|NCT00980551|Drug|subtenon Carboplatin|Available in 50mg, 150mg, 450 mg, 600mg vials. It is provided as a premixed aqueous solution or lyophilized powder for injection given on day 1/week 10 (cycles 1-3).
16253919|NCT00980551|Drug|Topotecan Hydrochloride|Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. Given intravenously on days 1-5 of each week (cycles 1-6).
16253920|NCT00980551|Drug|Vincristine|Each vial contains vincristine sulfate, 1 mg; mannitol, 100 mg; sterile water for injection; Acetic acid and sodium acetate are added for pH control. Given intravenously on day 1/week 1 (cycles 1-6).
16253921|NCT00980551|Drug|Filgrastim|Supplied as a clear solution in 300 mcg/ml 1 ml or 1.6 ml vials and prefilled syringes containing 300mcg/0.5mL or 480mcg/0.8mL. Given intravenously on day 6 of each week (cycles 1-6).
16253923|NCT00980512|Behavioral|Parent Training|16 weeks of parent training led by trained group facilitator
16253924|NCT00980473|Procedure|Argon Laser Iridoplasty|
16253925|NCT00980473|Drug|Travatan/ Timolol/Azopt|
16253926|NCT00980460|Drug|Cisplatin|Given IV
16253927|NCT00980460|Drug|Dexrazoxane|Given IV
16253928|NCT00980460|Drug|Doxorubicin Hydrochloride|Given IV
16253929|NCT00980460|Drug|Fluorouracil|Given IV
16253930|NCT00980460|Drug|Irinotecan Hydrochloride|Given IV
16253931|NCT00980460|Other|Laboratory Biomarker Analysis|Correlative studies
16253932|NCT00980460|Procedure|Liver Transplantation|Undergo liver transplant
16253933|NCT00980460|Drug|Temsirolimus|Given IV
16253934|NCT00980460|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16253935|NCT00980460|Drug|Vincristine Sulfate|Given IV
16253936|NCT00980447|Biological|UMN-0501|2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
16253937|NCT00980447|Biological|UMN-0501|2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart
16253938|NCT00980447|Biological|UMN-0501|2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart
16253939|NCT00980421|Dietary Supplement|Iron Supplementation|Iron tablet group (12.5 mg/d)+ Placebo Biscuit;Iron(12.5 mg/d)+ Zinc (10 mg/d) tablet group+ Placebo Biscuit; Iron Fortified Biscuit Group (12.5 mg/d)+ Placebo Tablet; Placebo tablet +Placebo Biscuit
16253940|NCT00980408|Drug|Sugar pill|250 mg, one dose, 60 min prior
16253941|NCT00980408|Drug|Sugar pill|250 mg, one dose, 60 min prior
16253942|NCT00980408|Drug|Sugar pill|20 mg, one dose, 8 hours prior
16253943|NCT00980408|Drug|Sugar pill|20 mg, one dose, 8 hours prior
16253944|NCT00980408|Drug|Glutamic Acid|250 mg, one dose, 60 minutes prior
16253945|NCT00980408|Drug|Glutamic Acid|250 mg, one dose, 60 minutes prior
16253946|NCT00980408|Drug|Memantine|20 mg, one dose, 8 hours prior
16253947|NCT00980408|Drug|Memantine|20 mg, one dose, 8 hours prior
16253948|NCT00980395|Drug|rituximab|375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
16253949|NCT00980395|Drug|bortezomib|1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
16253950|NCT00980395|Drug|cladribine|4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
16253951|NCT00980382|Drug|S-1, Docetaxel|"Phase I study
~S-1 (level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14
~Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) iv : Days 1, 8
~Phase II study
~S-1 (80mg/m2/day) q 12 hours po Days 1-14
~Docetaxel (35 mg/m2) iv : Days 1, 8"
16253952|NCT00980356|Drug|Vildagliptin|Patients receive once daily 50 mg Vildagliptin
16253953|NCT00980343|Drug|vismodegib|Given orally
16253954|NCT00980343|Procedure|therapeutic conventional surgery|undergo surgery
16253955|NCT00980343|Other|laboratory biomarker analysis|correlative studies
16253956|NCT00980343|Other|pharmacological study|correlative studies
16253957|NCT00980330|Drug|TMC435|One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
16253958|NCT00980330|Drug|Placebo|One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
16253959|NCT00980330|Drug|Peg-IFN-alfa-2a (P)|180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
16253960|NCT00980330|Drug|Ribavirin (R)|1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
16253961|NCT00980317|Procedure|Restored Kidney Transplant Between Third Parties|Tumor part of the donor kidney is surgically removed and the kidney is restored and transplanted to a third party recipient
16253962|NCT00980304|Drug|Rituximab|
16253963|NCT00980278|Procedure|Sinus lift augmentation and dental implant|transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.
16253964|NCT00980278|Biological|Aastrom BRCs|sinus augmentation, BRC application, dental implant
16253965|NCT00980252|Behavioral|Cognitive Behavioral Therapy|Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions
16253966|NCT00980239|Drug|Irinotecan|Starting dose of 35 mg/m^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
16253967|NCT00980239|Drug|Bevacizumab|10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
16253968|NCT00980239|Drug|Oxaliplatin|Starting dose 60 mg/m^2 by vein over 2 hours on Days 1 and 15 of every cycle.
16253969|NCT00980239|Drug|Cetuximab|500 mg/m^2 by vein on Days 1 and 15 of every cycle. The first time given over 2 hours, all other cycles over 1 hour.
16253970|NCT00980213|Drug|sunitinib|sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months
16253971|NCT00980200|Drug|Dose 4 QD|QD once daily
16253972|NCT00980200|Drug|Dose 3 QD|QD once daily
16253973|NCT00980200|Drug|placebo|placebo
16253974|NCT00980200|Drug|Dose 2 QD|QD once daily
16253975|NCT00980200|Drug|Dose 1 BD|BD twice daily
16253976|NCT00980187|Drug|Hydrochlorothiazide|orally, 25 mg, once a day, with Quinapril 10-40 mg, 6 months
16253977|NCT00980187|Drug|Indapamide|1.5 mg SR, orally, once a day,with Quinapril 10-40 mg, 6 months
16253978|NCT00980174|Drug|60 mg denosumab|60 mg denosumab (SC injection every 6 months)
16253979|NCT00980174|Other|Placebo|Placebo for denosumab (SC injection every 6 months)
16253980|NCT00980148|Drug|Azithromycin|FDA approved, a 1 gm single dose, two 500 mg tablets.
16253981|NCT00980148|Drug|Doxycycline|FDA approved, a 100 mg capsule twice a day for 7 days.
16253982|NCT00980135|Device|Sinecort cream|Application over 29 days
16253983|NCT00980135|Drug|Hydrocortison cream|Application over 29 days
16253984|NCT00980135|Other|Untreated skin|
16253985|NCT00980109|Drug|active oseltamivir|Oseltamivir capsules (75 mg per capsule), one capsule daily by mouth (PO) for 112 days. The dose should be administered at approximately the same time each day.
16253986|NCT00980109|Drug|placebo capsule|Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.
16253987|NCT00980109|Drug|zanamivir for inhalation|Zanamivir for inhalation, (5 mg per inhalation), two inhalations, once daily using a ROTADISK/DISKHALER for 112 days. The dose should be administered at approximately the same time each day.
16253988|NCT00980109|Drug|placebo for inhalation|Placebo (lactose powder), two inhalations, once daily using a ROTADISK/ DISKHALER for 112 days. The dose should be administered at approximately the same time each day.
16253989|NCT00980083|Drug|Saline|
16253990|NCT00980083|Drug|Exendin(9-39)amide|
16253991|NCT00980070|Device|Pediatric Restraint for Lumbar Puncture|Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure.
16253992|NCT00980070|Device|Lumbar Puncture Device|Lumbar Puncture positioner
16253993|NCT00980070|Other|Standard of Care|Lumbar Puncture positioner
16253994|NCT00980057|Device|Adaptive CRT (aCRT)|Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function
16253995|NCT00980057|Device|Echo|Standard BiV pacing with settings optimized using a standardized echocardiographic protocol
16253996|NCT00980044|Drug|Tramadol|Oral Medication
16253997|NCT00980044|Drug|Placebo|Oral Medication
16253998|NCT00980031|Drug|Eplerenone|25mg PO daily (QD)for 6 months
16253999|NCT00980031|Drug|Lactose Tablet|Lactose tablet
16254000|NCT00980018|Drug|Nilotinib|Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
16254001|NCT00980005|Biological|GSK investigational vaccine GSK1557482A|One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
16254002|NCT00980005|Biological|Fluzone®|One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
16254003|NCT00979992|Other|Laboratory Biomarker Analysis|Correlative studies
16254004|NCT00979992|Drug|Sunitinib Malate|Given PO
16254005|NCT00979966|Drug|Temsirolimus|25 mg intravenously, once weekly infusion
16254006|NCT00979966|Drug|Sunitinib|50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
16254007|NCT00979953|Drug|ADL5859|
16254008|NCT00979953|Drug|ADL5747|
16254009|NCT00979953|Drug|Oxycodone CR|
16254010|NCT00979953|Drug|Placebo|
16254011|NCT00979940|Drug|Atorvastatin|Atorvastatin 80mg po given one time before PCI in cath lab.
16254012|NCT00979927|Drug|SPC3649|5 weekly doses
16254013|NCT00979927|Drug|saline|5 weekly doses
16254014|NCT00979914|Other|Patient education programme|The intervention consisted of five group sessions, three hours for each session. The focus was on self-efficacy. Eight to ten patients participated in the programme at the same time.
16254015|NCT00979901|Drug|Comparator: montelukast|10 mg montelukast tablet given once daily at bedtime for 2 weeks
16254016|NCT00979901|Drug|Comparator: loratadine|10 mg loratadine tablet given once daily at bedtime for 2 weeks
16254017|NCT00979901|Drug|Comparator: placebo|placebo tablet given once daily at bedtime for 2 weeks
16254018|NCT00979901|Drug|Comparator: montelukast/loratadine|montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks
16254019|NCT00979888|Other|educational intervention|
16254020|NCT00979888|Other|informational intervention|
16254021|NCT00979888|Other|psychosocial support for caregiver|
16254022|NCT00979888|Other|questionnaire administration|
16254023|NCT00979888|Procedure|dyspnea management|
16254024|NCT00979888|Procedure|management of therapy complications|
16254025|NCT00979875|Drug|Recombinant human hyaluronidase PH20 (rHuPH20)|
16254026|NCT00979875|Drug|Insulin lispro|
16254027|NCT00979875|Drug|Insulin glulisine|
16254028|NCT00979875|Drug|Insulin aspart|
16254029|NCT00979862|Drug|Cediranib Maleate|Given PO
16254030|NCT00979862|Drug|Cilengitide|Given IV
16254031|NCT00979862|Other|Laboratory Biomarker Analysis|Correlative studies
16254032|NCT00979849|Drug|AZD8683|Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.
16254033|NCT00979849|Drug|Placebo|Solution for nebulisation, inhaled
16254034|NCT00979836|Drug|Calcium Dobesilate|500 mg/ three times/day for 6 months (capsules)
16254035|NCT00979823|Other|Early SimCare Diabetes Group|Residents in the early learning program group will participate in the learning cases before undergoing a knowledge and performance assessment. They will complete 18 learning cases, 4 assessment cases, knowledge survey, and a satisfaction survey.
16254036|NCT00979823|Other|Delayed SimCare Diabetes Group|Residents in the delayed learning program group will receive their usual diabetes training through their residency program for 8 months before completing the knowledge and performance assessment, and then will subsequently be offered the learning program. They will receive 4 assessment cases, knowledge survey, and satisfaction survey
16254037|NCT00979810|Drug|18F-FLT PET Scan|The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day.
16254038|NCT00979797|Other|Community-based interventions to promote maternal and child health|Promotion of antenatal and postnatal care and safe delivery Essential Newborn care Community case management, and feeding for children.
16254039|NCT00979784|Behavioral|Better Weight|Standard cognitive behavioral treatment focused on dietary & exercise behavior
16254040|NCT00979784|Behavioral|Better Weight & Better Sleep|Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT
16254041|NCT00979771|Drug|GSK706769|100 mg GSK706769 twice daily orally (BID) for 28 days
16254042|NCT00979771|Drug|Placebo|GSK706769 matched-placebo twice daily orally (BID) for 28 days
16254043|NCT00979758|Drug|Atorvastatin and mononuclear cells transplantation|Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
16254044|NCT00979745|Drug|Afamelanotide|One 16mg subcutaneous implant every 2 months for 9 months.
16254045|NCT00979745|Drug|Placebo|One 16mg subcutaneous implant every 2 months for 9 months.
16254046|NCT00979732|Dietary Supplement|grape seed extract|grape seed extract 150 mg twice a day (BID) in beverage or capsule form
16254047|NCT00979732|Dietary Supplement|grape seed extract placebo|grape seed extract 150 mg twice a day (BID) in beverage or capsule form
16254048|NCT00979719|Behavioral|Intervention Group (IG)|patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
16254049|NCT00979719|Behavioral|Active Control Group (ACG)|Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, W. & Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.)
16254050|NCT00979706|Drug|HAART|"Patients assigned to this arm will receive Trizivir and kaletra. After the first 9 months of HAART, all patients will stop HAART until HIV viral load in plasma became detectable (>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months.
~All patients will be followed-up during 1 year."
16254051|NCT00979706|Drug|HAART + Immunotherapy|"Patients assigned to this arm will receive Trizivir + Kaletra + cyclosporin A during the first two months. This group also will receive GM-CSF plus pegylated-interferon-alpha until HIV viral load in plasma became detectable (>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months. At this moment they will stop HAART.
~All patients will be followed-up during 1 year."
16254052|NCT00979693|Drug|psilocybin|25 mg psilocybin administered orally once during each of the two day-long psychotherapy sessions.
16254053|NCT00979693|Drug|psilocybin|4 mg psilocybin orally administered once during each of two day-long psychotherapy session
16254054|NCT00979680|Radiation|High-Dose radiotherapy|Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.
16254055|NCT00979680|Radiation|Chemo-radiotherapy|Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.
16254056|NCT00979667|Drug|Oseltamivir|75 mg twice daily for 5 days
16254057|NCT00979667|Drug|Zanamivir|10 mg twice daily for 5 days
16254058|NCT00979667|Drug|Placebo of Oseltamivir|twice daily for 5 days
16254059|NCT00979654|Drug|Sifalimumab|All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.
16254060|NCT00979641|Drug|Docetaxel|
16254061|NCT00979628|Drug|sliding scale regular insulin (SSRI)|four-time daily in patients with T2DM admitted to general medicine and surgery wards.
16254062|NCT00979628|Drug|Basal Bolus|glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
16254063|NCT00979628|Drug|Basal Plus|glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
16254064|NCT00979615|Drug|Olopatadine HCL (Patanase) Nasal Spray, 0.6%|2 sprays/ nostril BID
16254065|NCT00979615|Drug|Azelastine HCl (Astelin) Nasal Spray, 137 mcg|2 sprays/ nostril BID
16254066|NCT00979602|Biological|GSK2340274A|One intramuscular injection
16254067|NCT00979602|Biological|GSK2340273A|One intramuscular injection
16254068|NCT00979589|Drug|Clopidogrel|The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.
16254069|NCT00979589|Drug|Placebo of clopidogrel and Asprin|The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.
16254070|NCT00979576|Drug|BIBF 1120 M + Pemetrexed|BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m^2
16254071|NCT00979576|Drug|BIBF 1120 H + Pemetrexed|BIBF 1120 high dose bid+ Pemetrexed 500 mg/m^2
16254072|NCT00979576|Drug|BIBF 1120 RD + Pemetrexed|confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m^2
16254073|NCT00979576|Drug|BIBF 1120 L + Pemetrexed|BIBF 1120 low dose bid+ Pemetrexed 500 mg/m^2
16254074|NCT00979576|Drug|BIBF 1120 Placebo + Pemetrexed|placebo BIBF 1120 bid + Pemetrexed 500 mg/m^2
16254075|NCT00979563|Drug|HM30181AK tablet + Irinotecan tablets|HM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets
16254076|NCT00979550|Drug|Imiquimod|commercially available topical antiviral drug
16254077|NCT00979550|Drug|non-medicated petroleum cream|Over the counter topical cream used to aid the healing process in skin lesions
16254078|NCT00979537|Drug|Nisoldipine Extended-release Tablets, 40 mg|
16254079|NCT00979537|Drug|Sular Tablets, 40 mg|
16254080|NCT00979524|Behavioral|Comprehensive Mental Health Services and Supports|"This study uses a quasi-experimental design to test the efficacy of a comprehensive mental health intervention to improve the mental health and employment outcomes of young adults (18-24) enrolling in the Eastside YO Program. Newly enrolling Eastside YO members will receive an array of mental health education and services based on level of need and serve as this study's intervention group. Newly enrolling Westside YO members will receive usual care services delivered by the staff at the Westside YO Program and serve as this study's comparison group."
16254081|NCT00979511|Other|milk and exercise|"milk fortified with 1000mg calcium or low-calcium milk
~weight-bearing exercise or passive exercise"
16254082|NCT00979472|Drug|Solifenacin|oral
16254083|NCT00979459|Drug|MK-1006 DFC|Each dry filled capsule contains 20 mg MK-1006
16254084|NCT00979459|Drug|MK-1006 FCT|Each film coated tablet contains 40 mg of MK-1006
16254085|NCT00979446|Behavioral|Guided|Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
16254086|NCT00979446|Behavioral|Self-directed|Received study materials but no phone coaching
16254087|NCT00979433|Device|Bubble CPAP|Bubble CPAP will be delivered using Fischer & Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%.
16254088|NCT00979433|Device|Conventional CPAP|Conventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator.
16254089|NCT00979407|Biological|Influenza vaccine GSK2340272A|Two intramuscular injections at Day 0 and Day 21
16254090|NCT00979407|Biological|Influenza vaccine GSK2340274A|Two intramuscular injections at Day 0 and Day 21
16254091|NCT00979381|Biological|influenza vaccine|influenza vaccination
16254092|NCT00979368|Drug|BMS-816336|Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
16254093|NCT00979368|Drug|BMS-816336|Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
16254094|NCT00979368|Drug|BMS-816336|Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
16254095|NCT00979368|Drug|BMS-816336|Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
16254096|NCT00979368|Drug|BMS-816336|Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
16254097|NCT00979368|Drug|Placebo|Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
16254098|NCT00979355|Device|GP-D-SPECT|The D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient.
16254099|NCT00979342|Device|Hysteroscopic Morcellator|The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.
16254100|NCT00979329|Other|Questionnaires|During the study three questionnaires must repeatedly be completed in by the patients: the BDI (PC) a depression scale, the EORTC-QLQ a quality of life assessment and the CIS20r, a fatigue scale and patients must fill in their medication on a list.
16254101|NCT00979316|Drug|BMS-708163|Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
16254102|NCT00979316|Drug|BMS-708163|Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
16254103|NCT00979316|Drug|Placebo|Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
16254104|NCT00979316|Drug|Moxifloxacin|Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
16254105|NCT00979303|Device|Intracardiac echocardiography and 3D navigational system|Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.
16254106|NCT00979264|Behavioral|Intensive quality improvement tools|Personalized performance improvement interventions, including premier site data reports, personalized feedback/teleconferences, comprehensive toolkits, and focused webinars; in addition to other general QI tools typically available through participation in Get With the Guidelines Heart Failure.
16254107|NCT00979251|Drug|Oseltamivir Phosphate|Oseltamivir Phosphate, q8h
16254108|NCT00979251|Drug|ADS-8902|Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
16254109|NCT00979238|Genetic|Gene Transfer|Peripheral vein infusion of scAAV2/8-LP1-hFIXco vector once per participant
16254110|NCT00979238|Drug|scAAV2/8-LP1-hFIXco|Peripheral vein infusion of scAAV2/8-LP1-hFIXco vector once per participant.
16254111|NCT00979225|Other|Medication Management report|Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
16254112|NCT00979225|Other|Care manager email notices|Community-based care managers receive email notices if the patient has not seen his/her primary care provider in the past 6 months, has low adherence to medications, and has no scheduled appointment.
16254113|NCT00979212|Drug|panitumumab|Induction: 2.5 mg/kg, IV, days 1, 8, 15, 22, 29, 36 of radiation therapy before administration of chemotherapy and radiation therapy.
16254114|NCT00979212|Drug|carboplatin|Induction: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, AUC=6, IV, days 1 and 22.
16254115|NCT00979212|Drug|paclitaxel|Induction: 50 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, 200 mg/m2, IV, days 1 and 22.
16254116|NCT00979212|Procedure|surgery|A lobectomy or pneumonectomy performed 4-6 weeks after completion of induction chemoradiation
16254117|NCT00979199|Other|Non invasive cardiac imaging|Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
16254118|NCT00979186|Device|NOTES GEN 1 Toolbox|Articulating Hook Knife, Articulating Snare, Articulating Needle Knife Articulating Graspers, Articulating Biopsy Forceps, Steerable Flex Trocar with Rotary Access Needle, Flexible Bipolar Hemostasis Forceps, Flexible Maryland Dissector, and Tissue Apposition System.
16254119|NCT00979173|Drug|AC480|Subjects will be initiated on AC480 300mg orally BID for 14 (+/-2 days) before surgery. After surgery, subjects will continue to be dosed with AC480 until either disease progression or intolerance, and will be evaluated every other cycle (i.e., every 4 weeks).
16254120|NCT00979160|Drug|Dasatinib|Starting dosage 20mg once daily, that can be escalated up to 100mg once daily. Patient will remain on treatment for 12 months.
16254121|NCT00979147|Procedure|TKA surgery with modular polished tibial baseplate/XLK design|TKA surgery with modular polished tibial baseplate/XLK design
16254122|NCT00979147|Procedure|TKA surgery with the nonmodular APT/GVF design|TKA surgery with the nonmodular APT/GVF design
16254123|NCT00979147|Device|P.F.C.® Sigma Knee System|P.F.C.® Sigma Knee System with modular XLK poly
16254124|NCT00979147|Device|P.F.C.® Sigma Knee System|P.F.C. ® Sigma Knee System with an all-poly GVF tibia
16254125|NCT00979134|Drug|AZD4547|Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
16254126|NCT00979134|Drug|AZD4547|Patients start at a dose of 80 mg twice daily, with no washout
16254127|NCT00979134|Drug|AZD4547|Single dose is followed by washout 5-10 days before multiple dose
16254128|NCT00979121|Drug|Rosuvastatin|Subjects received an initial 40mg loading dose followed by 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital.
16254129|NCT00979121|Drug|Placebo|Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital.
16254130|NCT00979108|Other|Physical therapy rehabilitation|Mechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises.
16254131|NCT00979108|Other|Physical therapy rehabilitation|Subjects will be instructed in use of an over-the-door traction unit utilizing weights up to 20 pounds in sitting. In addition, subjects will be trained in neck and postural exercises.
16254132|NCT00979108|Other|Physical therapy rehabilitation|Subjects will be instructed in neck and postural exercises.
16254133|NCT00979069|Behavioral|Aerobic group|12 weeks of aerobic exercise 3 times a week
16254134|NCT00979056|Drug|Rifaximin|400 mg per day, oral use, maximum duration 28 days
16254135|NCT00979056|Drug|Lactose|Coated Tablet, Oral Use
16254136|NCT00979043|Behavioral|Dietary Weight-loss|The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.
16254137|NCT00979043|Behavioral|Exercise|Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.
16254138|NCT00979017|Drug|Avastin|Avastin, by intravenous infusion, 10 mg/kg every 14 days
16254139|NCT00979017|Drug|Temozolomide|Oral temozolomide at 200 mg/m2 daily for 5 days
16254140|NCT00979017|Drug|Irinotecan|Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)
16254141|NCT00979004|Drug|ICA-105665|Oral tablet. Dose forms of 50 and 100 mg or placebo will be used. A single dose will be administered that can range from placebo or 100 to 600 mg.
16254142|NCT00978978|Drug|Propofol VS. midazolam and fentanyl, endoscopies, liver diseases|"Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists'
~Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists"
16254143|NCT00978965|Genetic|MPA SNP|Functional relevant MPA SNP will be sought in patients DNA isolated from leucocytes
16254144|NCT00978952|Device|Large Diameter Advanta™ V12 Covered Stent|Stent placement
16254145|NCT00978939|Other|Standard Drainage Instructions|Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
16254146|NCT00978939|Other|Aggressive Drainage Instructions|Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
16254147|NCT00978913|Biological|DC vaccine|DC vaccination, one vaccine biweekly
16254148|NCT00978900|Dietary Supplement|Artificial sweeteners; Carbohydrate Sugars|sweetening agent dissolved in tap water, administered via intragastric tube
16254149|NCT00978900|Dietary Supplement|Water|
16254150|NCT00978887|Other|Retorna|Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.
16254151|NCT00978887|Other|Placebo|Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks
16254152|NCT00978874|Radiation|fludeoxyglucose F 18|
16254153|NCT00978874|Radiation|fluorine F 18 EF5|
16254154|NCT00978861|Drug|Hydrogen Peroxide|Whitening product syringe type
16254155|NCT00978835|Behavioral|Tailored telephone-based case management|Telephone calls by a nurse every two months to assess adherence to diet, physical activity, and pill-taking regimens. The nurse will then identify barriers to adherence to these recommendations and use motivational interviewing approaches to offer solutions to the barriers identified. No changes to medication are made.
16254156|NCT00978835|Behavioral|Nurse Education|Didactic, non-interactive education by a nurse on general health topics. Calls are made every two months.
16254157|NCT00978822|Drug|Clevidipine butyrate injectable emulsion|Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
16254158|NCT00978809|Other|Epley maneuver|
16254159|NCT00978809|Other|Semont maneuver|
16254160|NCT00978796|Drug|Sitagliptin|Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
16254161|NCT00978796|Drug|Sugar Pill|Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
16254162|NCT00978783|Device|Passy Muir Valve|The Passy Muir Valve was fixed on the tracheostomy tube
16254163|NCT00978783|Device|Positive end expiratory pressure|5 cm H2O PEEP was adjusted
16254164|NCT00978770|Drug|systemic chemotherapy|
16254165|NCT00978770|Procedure|diffusion-weighted magnetic resonance imaging|
16254166|NCT00978770|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16254167|NCT00978770|Procedure|magnetic resonance spectroscopic imaging|
16254168|NCT00978770|Procedure|neoadjuvant therapy|
16254169|NCT00978757|Drug|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
16254170|NCT00978757|Other|Placebo|saline solution
16254171|NCT00978731|Drug|Dasatinib|"Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules:
~5 days on, 2 days off
~6 days on, 1 day off
~Continuous daily dosing
~Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study"
16254172|NCT00978718|Dietary Supplement|high-selenium baker's yeast|Given orally
16254173|NCT00978718|Dietary Supplement|selenium|Given orally
16254174|NCT00978718|Other|placebo|Given orally
16254175|NCT00978705|Drug|Autologous cultured keratinocyte cell|3x10^7 cell/ vial
16254176|NCT00978692|Device|Toric Orthokeratology lenses|Children wearing toric orthokeratology at night for correcting astigmatism and myopia will be the study group
16254177|NCT00978692|Device|Single-vision spectacles|Children wearing single-vision spectacles in the daytime for correcting the refractive errors will serve as the control group
16254178|NCT00978679|Device|Orthokeratology lenses|Nightly use of orthokeratology lenses to correct the refractive errors
16254179|NCT00978679|Device|Spectacles|Daily use of single vision lenses to correct refractive errors
16254180|NCT00978653|Drug|allopurinol|150 mg once a day
16254181|NCT00978640|Other|fast and exercise|fasting 36 h and exercise 1 h 50% VO2max
16254182|NCT00978640|Other|exercise|exercise 1 h 50% VO2max
16254183|NCT00978627|Drug|insulin degludec/insulin aspart|Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
16254184|NCT00978627|Drug|insulin detemir|Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
16254185|NCT00978627|Drug|insulin aspart|Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
16254186|NCT00978627|Drug|insulin aspart|Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
16254187|NCT00978614|Drug|Neramexane|"Dosage form:
~25 mg immediate release [IR] tablets (=15.9 mg neramexane free base)
~37.5 mg IR tablets (=23.9 mg neramexane free base)"
16254188|NCT00978601|Procedure|Multimodal analgesic protocol during minimally invasive myomectomy|Multimodal and preemptive analgesia using 8 mg of Dexamethasone iv,trocar ports infiltration with 5 mL of a local anesthetic, consisting of 0.26% ropivacaine HCL (7.5 mg/mL) and 0.74% of 0,9 % sodium chloride, before the skin incision. About 10 minutes before the surgery is completed, 4 mg Ondansetron iv and a mixture of 75 mg diclofenac and 600 mg of paracetamol intramuscularly (im) are administered.
16254189|NCT00978588|Drug|6% hydroxyethyl starch 130/0.4 and 5% albumin|Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass
16254190|NCT00978575|Drug|ferricarboxymaltose|Single dose of maximum 1000 mg ferricarboxymaltose intravenous
16254191|NCT00978575|Drug|Ferrosulfate|200mg daily for 12 weeks
16254192|NCT00978575|Drug|Placebo|100 mg isotonic sodium and 2 placebo tablets daily
16254193|NCT00978562|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE-MRI
16254194|NCT00978562|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC-MRI
16254195|NCT00978562|Drug|Ferumoxytol Non-Stoichiometric Magnetite|Given IV
16254196|NCT00978562|Drug|Gadolinium|Given IV
16254197|NCT00978549|Drug|docetaxel|
16254198|NCT00978549|Drug|steroid therapy|
16254199|NCT00978549|Other|questionnaire administration|
16254205|NCT00978536|Other|Cognitive impairment of multiple sclerosis|Patients will get a lumbar puncture in order to measure the biomarkers in the CSF, a neuropsychological exam, an evaluation of the hippocampal volume by MRI and a cerebral scintigraphy.
16254206|NCT00978523|Drug|AR-12: (2-Amino-N-[4-[5-(2 phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] phenyl]-acetamide)|Oral, dose-escalation
16254207|NCT00978497|Drug|placebo|oral BID
16254208|NCT00978497|Drug|ANA598|oral 200mg BID
16254209|NCT00978497|Drug|ANA598|oral 400mg BID
16254210|NCT00978497|Drug|Peginterferon|180 μg dose via subcutaneous injection weekly
16254211|NCT00978497|Drug|Ribavirin|oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
16254212|NCT00978484|Behavioral|Virtual Reality Exposure Therapy - Dynamic|10 weeks of Virtual Reality Exposure using full, immersive VR
16254213|NCT00978484|Behavioral|Augmented Exposure Therapy|Exposure Therapy augmented with a still computer image
16254214|NCT00978471|Drug|Thiotepa|Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.
16254215|NCT00978458|Drug|temozolomide|Given orally
16254216|NCT00978458|Radiation|3-dimensional conformal radiation therapy|Given once daily 5 days a week for 5½ weeks
16254217|NCT00978458|Radiation|intensity-modulated radiation therapy|Given once daily 5 days a week for 5½ weeks
16254218|NCT00978445|Other|vMetrics protocol|use vmetrics protocol and device or use standard in clinic monitoring
16254219|NCT00978432|Drug|RAD001|10 mg/day for Part 1 of the trial
16254220|NCT00978432|Drug|LBH589|40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial
16254221|NCT00978432|Drug|Doublet (RAD001 and LBH589)|RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2.
16254222|NCT00978419|Drug|Rosuvastatin|Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days
16254223|NCT00978419|Drug|Placebo|Placebo administered every day for up to 28 days
16254224|NCT00978393|Drug|liraglutide|High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
16254225|NCT00978393|Drug|liraglutide|Low dose liraglutide treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
16254226|NCT00978393|Drug|liraglutide|Low dose liraglutide treatment (1.8 mg) followed by high placebo treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
16254227|NCT00978393|Drug|liraglutide|High placebo treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
16254228|NCT00978393|Drug|liraglutide|High dose liraglutide treatment (3.0) followed by low placebo treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
16254229|NCT00978393|Drug|liraglutide|Low placebo treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
16254230|NCT00978380|Drug|catridecacog|Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
16254231|NCT00978367|Drug|Avotermin|5 ng or 50 ng/100 ul avotermin applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on day 5 just prior to excision of the wound with a 5 mm surgical ellipse
16254232|NCT00978367|Drug|Avotermin|5 ng or 50 ng/100 ul avotermin applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on days 1 and 2. Dosing is repeated on day 5 (just prior to excision of the wound with a 5 mm surgical ellipse), 6 and 7.
16254233|NCT00978367|Drug|Avotermin|5 ng or 50 ng/100 ul avotermin applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on days 1, 2, 3 and 4. Dosing is repeated on day 5 (just prior to excision of the wound with a 5 mm surgical ellipse), 6, 7, 8 and 9.
16254234|NCT00978367|Drug|Placebo|Placebo applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on day 5 just prior to excision of the wound with a 5 mm surgical ellipse
16254235|NCT00978367|Drug|Placebo|Placebo applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on days 1 and 2. Dosing is repeated on day 5 (just prior to excision of the wound with a 5 mm surgical ellipse), 6 and 7.
16254236|NCT00978367|Drug|Placebo|Placebo applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on days 1, 2, 3 and 4. Dosing is repeated on day 5 (just prior to excision of the wound with a 5 mm surgical ellipse), 6, 7, 8 and 9.
16254237|NCT00978354|Drug|Furosemide|Continuous intravenous infusion of furosemide titrated to urine output
16254238|NCT00978354|Drug|Normal Saline|Continuous intravenous infusion 0.9% normal saline placebo control
16254239|NCT00978341|Drug|Pregabalin|Pregabalin 150mg capsules BID for 7.5 days
16254240|NCT00978341|Drug|Placebo for pregabalin|Placebo capsules BID for 7.5 days
16254241|NCT00978328|Drug|oxycodone immediate release (OXYRX)|Characteristics of pts. receiving prescription medications containing OXYRX
16254242|NCT00978315|Dietary Supplement|Cholecalciferol|Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
16254243|NCT00978315|Dietary Supplement|Miglyol oil|Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
16254244|NCT00978302|Drug|Avotermin|Intradermal injection, 50ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254245|NCT00978302|Drug|Avotermin|Intradermal injection, 100ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254246|NCT00978302|Drug|Avotermin|Intradermal injection, 500ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254247|NCT00978302|Drug|Avotermin|Intradermal injection, 1000ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254248|NCT00978302|Drug|Avotermin|Intradermal injection, 1μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254249|NCT00978302|Drug|Avotermin|Intradermal injection, 10μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
16254250|NCT00978302|Drug|Placebo (vehicle)|Intradermal injection at time of biopsy and again 24 h later
16254253|NCT00978250|Drug|5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)|FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
16254254|NCT00978237|Drug|EFV|one pill QD VO.
16254255|NCT00978237|Drug|LPV/r|2 pills QD VO
16254256|NCT00978224|Dietary Supplement|Viusid|3 Viusid bags (Orally administered) per day, for 60 weeks
16254257|NCT00978224|Dietary Supplement|Placebo|3 Placebo bags (Orally administered) per day, for 60 weeks.
16254258|NCT00978211|Drug|DOTA-TOC Treatment|"Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of
~renal toxicity
~loss of patient transferability or
~denial of further treatment."
16254259|NCT00978198|Drug|ASP1517|oral
16254260|NCT00978198|Drug|Placebo|oral
16254261|NCT00978185|Other|medical chart review|
16254262|NCT00978185|Other|questionnaire administration|
16254263|NCT00978185|Procedure|acupressure therapy|
16254264|NCT00978185|Procedure|quality-of-life assessment|
16254265|NCT00978185|Procedure|sham intervention|
16254266|NCT00978185|Procedure|standard follow-up care|
16254267|NCT00978172|Drug|artesunate and mefloquine|artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally
16254268|NCT00978159|Drug|esomeprazole|esomeprazole 20 mg po for 4 weeks
16254269|NCT00978159|Drug|Famotidine|Famotidine 40 mg po for 4 weeks
16254270|NCT00978146|Drug|Hydroxyurea|Patients will take oral hydroxyurea with a starting dose of 20 mg/kg daily. Patients will remain on hydroxyurea as long as there is a response or stability in tumor size and associated toxicities are manageable. Maximum treatment duration will be one year.
16254271|NCT00978133|Procedure|Dermabond ProPen (2-octylcyanoacrylate)|Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers
16254272|NCT00978133|Procedure|Skin closure with skin staples|Skin closure with skin staples
16254273|NCT00978120|Biological|H1N1 vaccine high dose|30 mcg of unadjuvanted Novartis H1N1 vaccine delivered as two, 15 micrograms (mcg), intramuscular injections. Each 30 mcg dose is administered 21 days apart.
16254274|NCT00978120|Biological|H1N1 vaccine low dose|15 mcg of unadjuvanted Novartis H1N1 vaccine delivered in two intramuscular injections 21 days apart
16254275|NCT00978107|Biological|MVA-FCU1, flucytosine|"TG4023: single IT injection; possibility to re-administer once,
~Percutaneous IT injections, under radiological or ultrasound imaging guidance
~Dose-escalating schedule of administration: 107 pfu (Cohort #1), 108 pfu (Cohort #2) and 4x108 pfu (Cohort #3),
~MTD injected to up to 3 different lesions (Cohort #4)
~5-FC (5-fluorocytosine)/flucytosine
~Dose and dosing schedule:
~Daily starting dose of 200 mg/kg; daily dose will be adjusted after measurement of 5-FC plasma concentration at steady state, which should be kept below 100 mg/L
~Duration: 2 weeks.
~Possible routes of administration:
~PO: 500 mg tablets, qid
~IV: 1% 250 mL vials, 45-minute infusions."
16254276|NCT00978081|Drug|aminolevulinic acid hydrochloride|Patients undergo continuous or fractionated photodynamic therapy.
16254277|NCT00978068|Drug|Lopinavir/Ritonavir (LPV/r)|
16254278|NCT00978068|Drug|Nevirapine (NVP)|NVP will be used for children < 3 years of age
16254279|NCT00978068|Drug|Efavirenz (EFV)|EFV for children ≥3 years of age
16254280|NCT00978068|Drug|2 nucleoside reverse transcriptase inhibitor (NRTI)|The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin < 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.
16254281|NCT00978055|Drug|1: Liothyronine Sodium Tablets|"Liothyronine Sodium Tablets, 50 mcg
~2 x 50 mcg, single-dose, fasting"
16254282|NCT00978055|Drug|2: Cytomel® Tablets|"Cytomel® Tablets, 50 mcg
~2 x 50 mcg, single-dose, fasting"
16254283|NCT00978042|Device|Juvéderm® VOLUMA XC|Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.
16254284|NCT00978029|Drug|Placebo|Placebo sublingual tablet, once daily
16254285|NCT00978029|Biological|SCH 39641|Allergy immunotherapy tablet (sublingual)
16254286|NCT00978029|Biological|SCH 39641|Allergy immunotherapy tablet (sublingual)
16254287|NCT00978016|Drug|arbaclofen placarbil-Cohort 1|After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg QD) for 7 weeks including titration and taper periods
16254288|NCT00978016|Drug|Placebo-Cohort 5|After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
16254289|NCT00978016|Drug|arbaclofen placarbil-Cohort 2|After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 40 mg QD) with for 7 weeks including titration and taper periods
16254290|NCT00978016|Drug|arbaclofen placarbil-Cohort 3|After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg BID) for 7 weeks including titration and taper periods
16254291|NCT00978016|Drug|arbaclofen placarbil-Cohort 4|After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 30 mg BID) for 7 weeks including titration and taper periods
16254292|NCT00978016|Drug|PPI|Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
16255406|NCT00970489|Drug|Placebo|Olive Oil capsules
16254295|NCT00977964|Other|Experimental milk protein infant formula Process A|ad lib for 1-8 days of age until 28 days of age
16254296|NCT00977964|Other|Experimental milk protein infant formula Process B|ad lib from 1-8 days of age until 28 days of age
16254297|NCT00977964|Other|Experimental milk protein infant formula Process C|ad lib from 1-8 days of age to 28 days of age
16254298|NCT00977964|Other|Experimental milk protein infant formula Process D|ad lib from 1-8 days of age until 28 days of age
16254299|NCT00977964|Other|Experimental milk protein infant formula Process E|ad lib from 1-8 days of age until 28 days of age
16254300|NCT00977964|Other|Experimental milk protein infant formula Process F|ad lib from 1-8 days of age until 28 days of age
16254301|NCT00977951|Drug|Intradermal avotermin|50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4
16254302|NCT00977951|Drug|Intradermal avotermin|50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6
16254303|NCT00977951|Drug|Placebo (vehicle)|Placebo administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4
16254304|NCT00977951|Drug|Placebo|50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6
16254305|NCT00977938|Drug|Placebo & Aspirin|
16254306|NCT00977938|Drug|Clopidogrel & Aspirin, Prasugrel & Aspirin|
16254307|NCT00977925|Biological|Fibrin Pad|Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
16254308|NCT00977925|Procedure|Standard of Care|Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.
16254309|NCT00977912|Dietary Supplement|Probiotic supplementation|one capsule containing probiotics per day added to milk
16254310|NCT00977912|Dietary Supplement|Milk containing placebo|one capsule containing placebo per day added to milk
16254311|NCT00977899|Biological|Malaria Transmission-Blocking Pfs25-Pfs25 Conjugate Vaccine|
16254312|NCT00977886|Drug|Placebo|Oral, 10 days
16254313|NCT00977886|Drug|ELB353|Oral, 10 days
16254314|NCT00977873|Dietary Supplement|Cholecalciferol|Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
16254315|NCT00977873|Dietary Supplement|Miglyol oil|Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
16254316|NCT00977860|Radiation|Stereotactic Body Radiation Therapy|36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
16254317|NCT00977847|Other|Electronic Health Portals for collecting Family History data|Comparison of multiple portals for integrating patient generated family history data into the electronic health record.
16254318|NCT00977821|Other|IVF|
16254319|NCT00977821|Other|Oocyte Vitrification|
16254320|NCT00977808|Device|Closed-Loop, Model Predictive Control (MPC)|Subjects used the OmniPod Insulin Management System (Insulet Corp.) and Insulin lispro (Eli Lilly, Indianapolis, IN). MPC algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician. Otherwise, the admission remained the same as in the open-loop admission (i.e. meals, sleep, etc...).
16254321|NCT00977808|Device|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects used their own insulin pumps and Insulin lispro (Eli Lilly, Indianapolis, IN). Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, sleep, etc...).
16254322|NCT00977795|Drug|5-aminolevulinic acid|oral doses in phase 1 study of 10mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg
16254323|NCT00977769|Drug|carbetocin 100 µg|Hemodynamic effect of
16254324|NCT00977769|Drug|oxytocin 5 u|Hemodynamic effect of
16254325|NCT00977769|Drug|placebo (NaCl)|Hemodynamic effect of
16254326|NCT00977756|Drug|Raltegravir (RAL)|400 mg twice daily (BID)
16254327|NCT00977756|Drug|Atazanavir (ATV)|300 mg daily
16254328|NCT00977756|Drug|Ritonavir (RTV)|100 mg daily, dosing by weight in Group I
16254329|NCT00977756|Drug|Tenofovir (TDF)|300 mg daily
16254330|NCT00977756|Drug|Etravirine (ETV)|200 mg BID
16254331|NCT00977756|Drug|Darunavir (DRV)|Dosing by weight
16254332|NCT00977756|Drug|Maraviroc (MVC)|150 mg BID in groups J and K; 600 mg BID in group L
16254333|NCT00977756|Drug|Lopinavir/ritonavir (LPV/r)|Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily
16254334|NCT00977730|Dietary Supplement|Protandim|1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
16254335|NCT00977730|Dietary Supplement|Placebo|1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
16254336|NCT00977704|Device|Restylane and Perlane|
16254337|NCT00977691|Procedure|PBSC Transplant|PBSC transplant
16254338|NCT00977691|Drug|Alemtuzumab|alemtuzumab
16254339|NCT00977691|Drug|Sirolimus|sirolimus
16254340|NCT00977691|Drug|Cyclophosphamide|cyclophosphamide
16254341|NCT00977691|Procedure|Low Dose Irradiation|low dose irradiation
16254342|NCT00977678|Other|open access gastroscopy|access to gastroscopy without preceding appointment
16254343|NCT00977678|Other|Gastroscopy by appointment|Gastroscopy after preceding appointment in a conventional outpatient clinic
16254344|NCT00977665|Drug|rasagiline mesylate|rasagiline 1 mg tablet/day for 48 weeks
16254345|NCT00977665|Drug|placebo|placebo tablet for 48 weeks
16254346|NCT00977652|Procedure|active stimulation|percutaneous posterior tibial nerve stimulation with following parameters: frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold during 3 months
16254347|NCT00977652|Procedure|sham stimulation|Same location with the same device than active stimulation but amplitude of stimulation = 0
16254348|NCT00977639|Procedure|Pathwork TOO test|
16254349|NCT00977626|Drug|Part 1 - AZD2423 or Placebo|AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days
16254350|NCT00977626|Drug|Part 2 - AZD2423|AZD2423 Oral solution, multiple dosing
16254351|NCT00977626|Drug|Part 3 - AZD2423|AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.
16254352|NCT00977613|Behavioral|exercise counseling|motivational counseling to exercise a minimum 18 metabolic hours per week
16254353|NCT00977600|Drug|HPN-100|HPN-100 is a triglyceride that has a similar mechanism of action as Buphenyl. It is a liquid with minimal taste and odor. HPN-100 is broken down to phenylbutyric acid (PBA). PBA is converted to phenyl acetic acid (PAA) that is the active metabolite. Three teaspoons of HPN-100 (~17.4mL) delivers equivalent amount of PBA that 40 tablets of NaPBA do.
16254354|NCT00977600|Drug|Ammonul|
16254355|NCT00977600|Drug|Buphenyl|
16254356|NCT00977587|Drug|Saccharomyces Cerevisiae CNCM I-3856|Saccharomyces cerevisiae CNCM I-3856, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu).subjects will take 1 capsule twice a day
16254357|NCT00977587|Drug|placebo|"Placebo: Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856:
~Calcium phosphate, Dibasic 472.0 mg
~Maltodextrin DE14 112.1 mg
~Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day"
16254358|NCT00977574|Biological|Bevacizumab|Given IV
16254359|NCT00977574|Drug|Carboplatin|Given IV
16254360|NCT00977574|Drug|Ixabepilone|Given IV
16254361|NCT00977574|Other|Laboratory Biomarker Analysis|Correlative studies
16254362|NCT00977574|Drug|Paclitaxel|Given IV
16254363|NCT00977574|Drug|Temsirolimus|Given IV
16254364|NCT00977561|Drug|figitumumab|Figitumumab (20 mg/kg)
16254365|NCT00977561|Drug|Cisplatin (Or Carboplatin)|Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
16254366|NCT00977561|Drug|Etoposide|Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
16254367|NCT00977561|Drug|Cisplatin (Or Carboplatin)|Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
16254368|NCT00977561|Drug|Etoposide|Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
16254369|NCT00977548|Drug|Erlotinib|Participants took erlotinib at least 1 hour before, or 2 hours after they ate a meal or snack. Participants were advised to take erlotinib at around the same time every day.
16254370|NCT00977522|Drug|PF-03463275|30 mg Controlled Release tablet BID for 12 weeks
16254371|NCT00977522|Drug|Placebo|Placebo tablet BID
16254372|NCT00977496|Procedure|Nasal Swab|Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the anterior vestibule of both nares and processed for S aureus cultures and for bacterial DNA extraction.
16254373|NCT00977483|Drug|Thioctic Acid|600mg tablet once daily 4 years double-blind treatment period
16254374|NCT00977483|Drug|Placebo|1 tablet once daily 4 years double-blind treatment period
16254375|NCT00977470|Drug|Erlotinib|150 mg taken orally once daily
16254376|NCT00977470|Drug|Hydroxychloroquine|1000 mg taken orally once daily after erlotinib
16254377|NCT00977457|Genetic|DNA analysis|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254378|NCT00977457|Genetic|DNA methylation analysis|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254379|NCT00977457|Genetic|RNA analysis|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254380|NCT00977457|Genetic|gene expression analysis|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254381|NCT00977457|Genetic|polymerase chain reaction|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254382|NCT00977457|Other|diagnostic laboratory biomarker analysis|Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
16254383|NCT00977457|Procedure|therapeutic conventional surgery|
16254384|NCT00977444|Drug|kondrium|intraarticular injections once month
16254385|NCT00977444|Drug|kondrium f|intraarticular injections once month
16254386|NCT00977444|Drug|methyl prednisolone (corticosteroid)|intraarticular injections once month
16254387|NCT00977431|Drug|Temozolomide|During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)
16254388|NCT00977431|Procedure|Radiotherapy|Day 1 to day 42
16254389|NCT00977431|Drug|BIBW2992|Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT
16254390|NCT00977431|Procedure|Radiotherapy|Day 1 to day 42
16254391|NCT00977431|Drug|BIBW2992|Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT
16254392|NCT00977418|Behavioral|SMART- Strategic Memory and Reasoning Training|Teach people to filter out un necessary or unimportant details to enhance mental efficiency. This training will be done over 12 weeks for 3 hours each week.
16254393|NCT00977418|Other|Physical Exercise|The group with undergo 1 hour of aerobic exercise (at 50-70 % of the participants max oxygen intake) 3 times a week for 12 weeks.
16254394|NCT00977405|Device|Collatamp Gentamicin Implant|Collatamp Gentamicin placed into subcutaneous layer of dirty abdominal wounds
16254395|NCT00977392|Behavioral|compliance monitoring|
16254396|NCT00977392|Other|cervical Papanicolaou test|
16254397|NCT00977392|Other|educational intervention|
16254398|NCT00977392|Other|screening questionnaire administration|
16254399|NCT00977392|Other|survey administration|
16254400|NCT00977392|Procedure|colposcopy|
16254401|NCT00977379|Radiation|WBRT|3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
16254402|NCT00977379|Drug|Capecitabine|825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2.
16254403|NCT00977379|Drug|Standard of Care|The choice of standard of care will be at the discretion of the treating oncologist. The protocol does not specify any particular standard of care treatment.
16254404|NCT00977366|Other|Hydrochloric acid (0.15 molar)|Hydrochloric acid (0.15 molar) will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.
16254405|NCT00977366|Other|Saline|Normal saline will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.
16254406|NCT00977353|Drug|citalopram|20-60 mg/day, oral, for 6 weeks
16254407|NCT00977353|Drug|sarcosine|500-1500 mg/day, oral, for 6 weeks
16254408|NCT00977340|Behavioral|Imagery Rehearsal Treatment|Imagery Rehearsal Therapy
16254409|NCT00977340|Behavioral|confrontation|Confrontation
16254410|NCT00977340|Behavioral|imagination|Imagination
16254411|NCT00977327|Device|Intraoperative MR (PoleStar N-20, Medtronics)|intraoperative imaging for resection control of intraaxial brain lesions
16254412|NCT00977327|Device|Intraoperative Ultrasound (Sonowand, Mison)|intraoperative imaging for resection control of intraaxial brain lesions
16254413|NCT00977314|Device|The Sonitus Bone Conduction Hearing System|Comparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed.
16254414|NCT00977314|Device|SoundBite|
16254415|NCT00977314|Device|SoundBite Hearing System|
16254416|NCT00977301|Drug|fosamprenavir/ritonavir|16 days 700mg/100mg RTV BID
16254417|NCT00977301|Drug|olanzapine|15 mg olanzapine single dose
16254418|NCT00977301|Drug|olanzapine|10 mg olanzapine single dose
16254419|NCT00977288|Drug|anacetrapib|10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
16254420|NCT00977288|Drug|Comparator: atorvastatin|atorvastatin tablet, 10mg, once daily for 8 weeks
16254421|NCT00977288|Drug|Comparator: Placebo|Placebo tablet, once daily for 8 weeks
16254422|NCT00977275|Radiation|Interstitial Implant Brachytherapy|Via tubes placed at the time of wide local excision delivered over 5 days
16254423|NCT00977262|Other|High saturated fat shake|milkshake containing 95 gram of fat, high percentage of saturated fat
16254424|NCT00977262|Other|High monounsaturated fat shake|milkshake containing 95 gram of fat, high percentage of monounsaturated fat
16254425|NCT00977262|Other|High polyunsaturated fat shake|milkshake containing 95 gram of fat, high percentage polyunsaturated fat
16254426|NCT00977249|Behavioral|support and visits|visits at weeks 0,2,4,6,9 and 12 and 12 months
16254427|NCT00977249|Drug|varenicline|
16254428|NCT00977249|Drug|placebo|
16254429|NCT00977236|Device|Orthokeratology lenses|Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years
16254430|NCT00977236|Device|Single-vision spectacle lenses|Daily use of spectacles to correct the refractive error for a period of two years
16254431|NCT00977223|Drug|aprepitant/placebo|Aprepitant, 125 MG at day 1 then 80 MG day 2-7, once a day, per os, at 8 AM during breakfast
16254432|NCT00977210|Drug|OXi4503|OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.
16254433|NCT00977197|Drug|Pregabalin|Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
16254434|NCT00977197|Drug|Placebo|A matching placebo will be administered twice a day
16254435|NCT00977184|Procedure|50 HZ Repetitive TMS|
16254436|NCT00977184|Procedure|Sham rTMS|
16254437|NCT00977171|Drug|Droxidopa|Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
16254438|NCT00977158|Procedure|Throat Swab|Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the throat and processed for bacterial cultures and for bacterial DNA extraction.
16254439|NCT00977145|Biological|A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1|"Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, 15. During cycle two, three vaccines will be administered over a 9-week period on days 24, 43, 64. All participants will receive 12-MP (100 mcg each peptide) plus Peptide-tet (Peptide-tet; 200 mcg) administered in Montanide ISA-51 VG adjuvant. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site.
~Intratumoral Interferon regimen: On day 22, patients will have one or more tumor sites injected with 0.5-2 million IU of IFN-gamma each, with a maximum dose of 2 million IU of IFN-gamma administered per patient. The number of lesions that are injected will be dependent on the availability and size of the lesions."
16254440|NCT00977132|Drug|Valproic aicd|"Treatment with VPA starts at day1, the dose ist slowly increase according to the following scheme
~day morning dose midday dose evening dose contents of 1 tablet
~1+2 0 0 1 500 mg
~3+4 ½ 0 1 500 mg
~5+6 1 0 1 500 mg
~7+8 1 ½ 1 500 mg
~9+10 1 1 1 500 mg
~11+12 1 1 1 500 mg
~In the morning of day 13 trough level of VPA will be checked. The target range will be 50-110 µg/l. The dose of VPA will be adjusted depending on the trough level. In the first eight weeks of therapy weekly controls of VPA levels are required. Thereafter, VPA levels will be checked every four weeks."
16254441|NCT00977132|Drug|Lenalidomide|"5 mg/day, continuous therapy
~Dosing will be in the morning at approximately the same time each day. Capsules may be taken before or after a meal.
~Only one cycle of study drug (28 days) will be supplied to the patient every four weeks"
16254442|NCT00977119|Other|Side-effect questionnaires|Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
16254443|NCT00977119|Other|research blood samples|Blood samples for research on DNA before starting treatment and after 4 cycles of treatment
16254444|NCT00977106|Drug|tocilizumab [RoActemra/Actemra]|single iv infusion 8 mg/kg
16254445|NCT00977106|Drug|placebo|single iv infusion
16254446|NCT00977106|Drug|tocilizumab [RoActemra/Actemra]|iv infusion 8mg/kg every 4 weeks for 11 months
16254447|NCT00977093|Other|Perfusion CMR for detection of coronary artery disease|Perfusion CMR is performed during adenosine infusion for vasodilation (3 minutes of 0.14mg/kg/min IV) and injection of Gd-DTPA-BMA at 0.075mmol/kg IV.
16254448|NCT00977093|Other|Perfusion cardiac magnetic resonance imaging|Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease
16254449|NCT00977080|Drug|Paricalcitol|Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
16254450|NCT00977080|Drug|Cinacalcet|On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)
16254451|NCT00977067|Drug|GDC-0152|Intravenous escalating dose
16254452|NCT00977054|Drug|DFPP + Peg-IFN + RBV|Double filtration plasmapheresis: day 1,2,4,8,9 from the onset of treatment (4 hours for each session) Peginterferon alfa-2a: week 1-48, weekly subcutaneous 180 ug Ribavirin: week 1-48, daily oral 1,000-1,200 mg (body weight < 75 kg, 1,000 mg/day; body weight loss >= 75 kg, 1,200 mg/day)
16254453|NCT00977054|Drug|Peg-IFN + RBV|Peginterferon alfa-2a: week 1-48, weekly subcutaneous 180 ug Ribavirin: week 1-48, daily oral 1,000-1,200 mg (body weight < 75 kg, 1,000 mg/day; body weight loss >= 75 kg, 1,200 mg/day)
16254454|NCT00977041|Behavioral|Neurofeedback|"Electrodes will be placed over the temporal lobes bilaterally and a ground electrode placed on the left earlobe. EEG activity will be amplified using a Procomp 2 or Nexus amplifier, and EEGer software will be used to provide subjects with feedback. Contingencies will be set such that alpha brain activity will be reinforced, and high beta and theta brain activity will be inhibited. Standard NF training procedures will be used, which involve simply asking subjects to relax while looking at the feedback screen and Do whatever is necessary to make and keep the bar wide. This protocol will be repeated for up to 40 60-minute sessions (that will include 30 minutes of NF training), scheduled at least weekly."
16254455|NCT00977028|Drug|Tumescent Local Anesthesia (lidocaine, epinephrine)|Tumescent solution of lidocaine (up to 1 gm per liter) and epinephrine (up to 1 mg per liter)with subcutaneous infiltration of up to 45 mg per kilogram
16254456|NCT00977028|Procedure|Liposuction|Subcutaneous infiltration of tumescent local anesthesia (large volumes of dilute lidocaine and epinephrine) on at least two different occasions, followed by sequential serum samples every two hours for HPLC determination of serum lidocaine concentration and peak serum lidocaine concentration, initially without subsequent liposuction and finally on the last occasion with liposuction
16254457|NCT00977015|Drug|Treatment A|Inhaled, 750/150, single dose
16254458|NCT00977015|Drug|Treatment B|Inhaled, 750/150, single dose
16254459|NCT00977002|Other|Positive Pressure Noninvasive ventilation|Patients randomized to this group are submitted to positive pressure noninvasive ventilation for 12 hours or more. Children younger than one year use nasal prong and older than one year use nasal or facial mask. A blood gas is collected in the moment of intubation and one hour after.
16254460|NCT00977002|Other|Inhalatory O2|Patients randomized to this group are submitted to inhalatory O2 using mask or nasal catheter. A blood gas is collected in the moment of intubation and one hour after.
16254461|NCT00976989|Drug|Pertuzumab|840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.
16254462|NCT00976989|Drug|Trastuzumab|8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.
16254463|NCT00976989|Drug|FEC|5-fluorouracil 500 mg/m^2, epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2.
16254464|NCT00976989|Drug|Docetaxel|75 mg/m^2 for the first dose; 100 mg/m^2 if no dose limiting toxicity occurs.
16254465|NCT00976989|Drug|TCH|Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m^2. All treatments were given every three weeks by the IV route.
16254466|NCT00976976|Drug|docetaxel, capecitabine, cisplatin|Docetaxel 60 mg/m2 IV (day 1) every 21 days capecitabine 1,875 mg/m2/day PO, divided two (day 1-day14) every 21 days Cisplatin 60 mg/m2 IV (day 1) every 21 days
16254467|NCT00976963|Drug|Fosfomycin|3g sachet single dose
16254468|NCT00976963|Drug|TMP/SMX DS|160/800mg BID x 3 days
16254469|NCT00976950|Drug|Tipranavir|
16254470|NCT00976950|Drug|ritonavir|low-dose
16254471|NCT00976937|Drug|Lixisenatide (AVE0010)|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16254472|NCT00976937|Drug|Lixisenatide Placebo|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16254473|NCT00976937|Device|Pen auto-injector|
16254474|NCT00976937|Drug|Sitagliptin|Administered orally once a day in the morning with or without food at approximately the same time each day.
16254475|NCT00976937|Drug|Sitagliptin Placebo|Administered orally once a day in the morning with or without food at approximately the same time each day.
16254476|NCT00976937|Drug|Metformin|Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
16254477|NCT00976924|Device|blood glucose monitor|Blood glucose monitor is used to monitor the blood glucose level of the human-being.
16254478|NCT00976911|Drug|bevacizumab [Avastin]|10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
16254479|NCT00976911|Drug|liposomal doxorubicin|40mg/m2 iv every 4 weeks
16254480|NCT00976911|Drug|paclitaxel|80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
16254481|NCT00976911|Drug|topotecan|4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
16254482|NCT00976898|Radiation|Proton Beam Irradiation|Given once a day, 5 days a week, for 3 weeks
16254483|NCT00976872|Drug|omega-3|"omega-3: 2 pills of Omega950®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA"
16254484|NCT00976872|Drug|placebo|hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil
16254485|NCT00976859|Behavioral|Imagery Modification|Research via internet concerning the frequency of skin exchange and disputation of the collected information; in the guided imagery modification the therapist instructs the patient to imagine the feeling of being contaminated and the process of peeling off their former contaminated skin and the maturing of hundreds of new clean skin cells
16254486|NCT00976859|Behavioral|Waitlist control group|Patients in the wait list control group are treated after a waiting period of five weeks
16254487|NCT00976846|Device|Dialyzer Baxter Xenium XPH 210|High-Flux dialyzer
16254488|NCT00976833|Other|Standardized Rehabilitation|3 component Rehabilitation approach, Passive Range of Motion, Physical Therapy and Progressive Resistance Training
16254489|NCT00976833|Other|Usual Care|Usual Physical Therapy care
16254490|NCT00976820|Biological|GSK2340274A|Two intramuscular injections
16254491|NCT00976820|Biological|GSK2340273A|Two intramuscular injections
16254537|NCT00976456|Drug|Bevacizumab + Pemetrexed + Carboplatin|Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
16254492|NCT00976807|Other|Pulmonary Rehabilitation|"Eight week programme of twice-weekly (sixteen sessions) supervised exercise and education sessions. Exercise will include aerobic cardiovascular and upper and lower limb strengthening exercises. Each session will comprise a warm-up period, followed by individualised exercises, and completed with a cool-down, and last approximately 40minutes.
~Aerobic exercise will be prescribed based on the results of walking tests and include walking, step-ups, cycling, and strength prescription according to the repetition maximum principle. Patients will complete three sets using this weight.
~Furthermore Borg scores will be used within each session to guide and direct exercise intensity. A home exercise programme will also be designed and accompanied by a manual detailing the individual warm-up, exercises and cool-down, and diary sections to record independent activity.
~Each session will also include an education session where relevant."
16254493|NCT00976794|Drug|lithium plus carbamazepine|"Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
~Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability"
16254494|NCT00976794|Drug|lithium plus valproate|"Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
~Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability."
16254495|NCT00976768|Drug|oxaliplatin, 5-fluorouracil|Oxaliplatin 85 mg/㎡ IV, day 1 over 2 hours 5-FU 400 mg/㎡ IV bolus day 1 followed by 5-fluorouracil(FU) 2,400 mg/㎡ and leucovorin (LV) 100 mg/㎡ IV continuous over 46 hours (every 2 weeks)
16254496|NCT00976755|Drug|everolimus|"Everolimus:
~10mg daily"
16254497|NCT00976742|Behavioral|Endurance exercise training|
16254498|NCT00976729|Drug|NOX-E36|single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
16254499|NCT00976729|Drug|NOX-E36|single SC doses, at safe and tolerable dose level
16254500|NCT00976729|Drug|Placebo|
16254501|NCT00976716|Drug|Celecoxib|"Day 1
~The first dose: Celecoxib 400mg
~The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed
~Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)
~- Celecoxib 200mg twice daily"
16254502|NCT00976703|Other|weighted bag|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
16254503|NCT00976703|Other|leg taping|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
16254504|NCT00976690|Drug|Azathioprine OR Mesalazine|Azathioprine : 2mg/kg/day Mesalazine : 4g/day
16254505|NCT00976677|Drug|erlotinib hydrochloride|Given PO
16254506|NCT00976677|Drug|paclitaxel|Given IV
16254507|NCT00976677|Drug|carboplatin|Given IV
16254508|NCT00976677|Biological|bevacizumab|Given IV
16254509|NCT00976664|Device|Shoe orthotic|Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
16254510|NCT00976664|Device|Shoe Orthotic Wait Group|This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.
16254511|NCT00976651|Drug|human menopausal gonadotropin|200 IU per day in the late follicular phase
16254512|NCT00976638|Other|Chromogenic surveillance|All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive
16254513|NCT00976638|Other|Molecular surveillance|All patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated
16254514|NCT00976625|Procedure|Aortic Valve Replacement|Surgical valve replacement of the aorta
16254515|NCT00976612|Drug|Nilotinib|Nilotinib 400mg bid daily
16254516|NCT00976599|Drug|CP-690,550 + methotrexate|CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
16254517|NCT00976599|Drug|Placebo + Methotrexate|Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
16254518|NCT00976573|Biological|bevacizumab|Given IV
16254519|NCT00976573|Drug|carboplatin|Given IV
16254520|NCT00976573|Drug|everolimus|Given orally
16254521|NCT00976573|Drug|paclitaxel|Given IV
16254522|NCT00976560|Drug|GW856553|Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553
16254523|NCT00976560|Other|Placebo|Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.
16254524|NCT00976534|Drug|AZD1386|90 mg, capsules, oral, during 3 weeks
16254525|NCT00976534|Drug|Placebo|capsules, oral, during 3 weeks
16254526|NCT00976521|Drug|Abciximab local infusion|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter
16254527|NCT00976521|Other|No local infusion|Intervention without local infusion
16254528|NCT00976521|Procedure|Thrombus aspiration|Thrombus aspiration
16254529|NCT00976508|Drug|figitumumab|IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
16254530|NCT00976508|Drug|pegvisomant|growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
16254531|NCT00976495|Drug|Dapagliflozin|Tablets, Oral, 10 mg, once daily, 12 weeks
16254532|NCT00976495|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 12 weeks
16254533|NCT00976495|Drug|Hydrochlorothiazide|Tablets, Oral, 25 mg, once daily, 12 weeks
16254534|NCT00976469|Biological|H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)|2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age
16254535|NCT00976469|Biological|Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011|Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)
16254536|NCT00976456|Drug|Bevacizumab + Pemetrexed|Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
16254655|NCT00975637|Drug|Placebo|Placebo SC
16254538|NCT00976443|Drug|BTA|BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
16254539|NCT00976443|Drug|Placebo (normal saline)|Placebo (normal saline), gastric injections of normal saline
16254540|NCT00976430|Procedure|Autologous Bone marrow derived stem cells transplant|Stem cells are derived from the bone marrow of the patient and processed at Reliance life sciences.The stem cells are the stereotactically implanted in the striatum.
16254541|NCT00976404|Biological|DNA + HIV-rAd5 vaccine|4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5)
16254542|NCT00976404|Drug|ART intensification (raltegravir)|raltegravir 400 mg PO BID for 56 weeks
16254543|NCT00976404|Drug|ART intensification (maraviroc)|maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks
16254544|NCT00976391|Biological|albiglutide + insulin glargine|albiglutide in combination with insulin glargine
16254545|NCT00976391|Drug|insulin glargine + preprandial lispro insulin|insulin glargine in combination with preprandial lispro insulin
16254546|NCT00976378|Drug|NOX-A12|single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
16254547|NCT00976378|Drug|NOX-A12|single IV dose, at efficacious dose level
16254548|NCT00976365|Dietary Supplement|THL-P|20ml/bottle, TID, 24weeks
16254549|NCT00976352|Drug|rAAV1-CMV-GAA (study agent) Administration|rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.
16254550|NCT00976352|Other|RMST|After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270.
16254551|NCT00976339|Drug|Cholecalciferol|"Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D.
~Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each."
16254552|NCT00976326|Drug|insulin degludec|The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
16254553|NCT00976313|Procedure|Assessment of urinary micturition after thoracotomy|Post residual urine volume and voided volume will be assessed with Bladder Scan™ BVI 6100 (Bladder scan, Bothell, WA, USA) will be performed the day before surgery and on day 2 after surgery, with epidural analgesia within segments T2-4 to T10 21,22. Bladder sensitivity will be assessed at strong desire to void. On day 2 the bladder will be filled through the transurethral catheter till the patient signalised a strong desire to void, then the catheter will be removed and spontaneous micturition will be attempted. Voided volume and post void residual will be assessed.
16254554|NCT00976313|Other|International Prostate Symptom Score|International Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively
16254555|NCT00976300|Drug|Cyclosporine A|Cyclosporine arm (CyA group) consisted of oral cyclosporine A (CyA) 4-5mg/kg/day (given in two divided doses) for 9 months followed by gradually decreasing dose of cyclosporine (3.75-1.25 mg/kg/day) within the next 9 months. The dosage of concomitant glucocorticoids was driven and tapered according to a single treatment protocol.
16254556|NCT00976300|Drug|Cyclophosphamide|Cyclophosphamide (CPH) therapeutic arm (CPH group) consisted of 8 boluses of intravenous cyclophosphamide (10mg/kg) given within 9 months in subsequently prolonged intervals (2x3weeks, 4x4 weeks, 2x6 weeks) followed by 4-5 oral cyclophosphamide boluses (10mg/d in 6-8 week intervals). The dosage of concomitant glucocorticoids was driven and tapered according to a single treatment protocol.
16254557|NCT00976287|Procedure|Hepatic artery infusion|Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.
16254558|NCT00976287|Procedure|Conserved Therapy|Conserved Therapy
16254559|NCT00976274|Dietary Supplement|Korean red ginseng|5 capsules (300 mg/capsule) three times everyday for 12 weeks
16254560|NCT00976274|Dietary Supplement|starch|5 capsules three times everyday for 12 weeks
16254561|NCT00976261|Drug|GSK1614235|Glucose lowering in Type 2 Diabetes Mellitus
16254562|NCT00976261|Drug|Sitagliptin|Glucose lowering in Type 2 Diabetes Mellitus
16254563|NCT00976261|Other|Placebo|Comparator
16254564|NCT00976248|Drug|RAD001|Taken orally once a day
16254565|NCT00976235|Device|IMT - Implantable Miniature Telescope|Implantation of the telescope prosthesis (performed under the initial study)
16254566|NCT00976222|Drug|intravitreal injection with ranibizumab|0.5 mg in 0.05 ml, monthly, 12 months
16254567|NCT00976209|Drug|Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg|Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.
16254568|NCT00976209|Drug|Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg|Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
16254569|NCT00976183|Drug|Vorinostat|Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
16254570|NCT00976183|Drug|Vorinostat|Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
16254571|NCT00976170|Drug|GC33(RO5137382)|IV administration at 6 escalating dose levels.
16254572|NCT00976170|Drug|Sorafenib|Oral administration at 400mg twice daily or 400mg once daily
16254573|NCT00976157|Procedure|Bronchoscopy BAL|The bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia. The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected. Five aliquots of 20ml sterile saline were instilled and aspirated gently. The first aliquot was discarded and the last 4 aliquots were pooled for analysis. Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture.
16254574|NCT00976144|Drug|GSK573719|GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist or anticholinergic bronchodilator. GW642444 is a potent and selective long-acting beta-2 agonist. Both are in development for once daily monotherapies for the treatment of COPD. In this study, their effects are investigated following individual and concurrent administration.
16254575|NCT00976131|Drug|Coenzyme Q10|"Dose Level 1:
~300mg/d (2 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 300mg/d placebo (2 capsules)taken daily for two weeks prior to Cycle 4 infusion of doxorubicin.
~Dose Level 2:
~600mg/d (4 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 600mg/d placebo (4 capsules) taken daily for two weeks prior to Cycle 4 infusion of doxorubicin.
~Dose Level 3:
~1200mg/d (8 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 1200mg/d placebo (8 capsules) taken daily for two weeks prior to Cycle 4 infusion of doxorubicin."
16254576|NCT00976131|Other|Coenzyme Q10 Placebo|"Dose Level 1:
~300mg/d placebo (2 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 300mg/d (2 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin.
~Dose Level 2:
~600mg/d placebo (4 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 600mg/d (4 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin.
~Dose Level 3:
~1200mg/d placebo (8 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 1200mg/d (8 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin."
16254577|NCT00976118|Drug|masitinib (AB1010)|oral masitinib 3 or 6 mg/kg/day
16254578|NCT00976118|Drug|placebo|matching placebo to masitinib
16254579|NCT00976105|Drug|Zolpidem or placebo - Hypnotic drug given for sleep disorders|The information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B.
16254580|NCT00976105|Drug|GSK1521498 or placebo|The first group will start at a low dose (10 mg GSK1521498 or placebo) for 10 days. The study team will then assess the data gathered from the first cohort and will select the dose that the next cohort will receive for 10 days. There will be up to 4 cohorts.
16254581|NCT00976092|Drug|Prasugrel|60 mg prasugrel as loading dose prior to PPCI
16254582|NCT00976092|Drug|Bivalirudin|IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
16254583|NCT00976092|Drug|Clopidogrel|600 mg clopidogrel as loading dose before PPCI
16254584|NCT00976092|Drug|Heparin|i.v. bolus of 70-100 IU/kg body weight
16254585|NCT00976079|Device|Transcutaneous electrical nerve stimulation (TENS)|Continuous TENS use
16254586|NCT00976079|Device|Placebo TENS|Placebo TENS use
16254587|NCT00976066|Drug|Part A Assessing GSK1521498|"Each participant will receive up to three [11C]carfentanil PET scans and up to two doses of GSK1521498 in total. The doses used will span the expected receptor occupancy range providing these were well tolerated in the first-time in human study.
~Each subject will receive baseline [11C]carfentanil PET and fMRI scans (PET Scan 1 and fMRI Scan 1, respectively), followed by two treatment sessions (Treatment Sessions 1 and 2). Treatment session 1 and 2 are followed by PET scans and an fMRI scan (session 1 only). Sessions will be separated by at least 12 days. PET scans will be timed to coincide with peak brain occupancy. fMRI will begin approximately 30-60 minutes after completion of the PET scan."
16254588|NCT00976066|Drug|Part B Assessing GSK1521498|"The purpose of Part B is to establish the timecourse of receptor occupancy of GSK1521498. Each participant in Part B will receive up to three [11C]carfentanil PET scans and one single oral dose of GSK1521498 expected to provide 50-75% receptor occupancy (selected with reference to data from Part A).
~Each Part B subject will receive baseline [11C]carfentanil PET and fMRI scans (PET Scan 1 and fMRI Scan 1, respectively) followed by a single treatment session. The treatment session will consist of a single oral dose of GSK1521498 followed by two subsequent PET scans (PET Scans 2 and 3) and one fMRI scan (fMRI Scan 2)."
16254589|NCT00976066|Drug|Part C Assessing Naltrexone|A range of doses of naltrexone will be tested in up to 12 participants in an adaptive design. Each Part C participant will receive up to three [11C]carfentanil PET scans and a single oral dose of naltrexone. No dose of naltrexone will exceed 50 mg, the dose usually used therapeutically in the treatment of opiate and alcohol dependence. Each Part C subject will receive baseline [11C]carfentanil PET and fMRI scans (PET Scan 1 and fMRI Scan 1, respectively) followed by a single treatment session. The treatment session will consist of a single oral dose of naltrexone followed by two subsequent PET scans (PET Scans 2 and 3) and one fMRI scan (fMRI Scan 2).
16254590|NCT00976053|Procedure|Myocardial perfusion imaging|Randomization assignment to one of SPECT or PET myocardial perfusion imaging
16254591|NCT00976040|Other|Early antiretroviral therapy|"The intervention is early initiation of antiretroviral therapy after diagnosis of Cryptococcal meningitis.
~In the intervention/experimental arm, triple-drug highly active antiretroviral therapy regimens will be initiated within 7 days of diagnosis of Cryptococcal meningitis."
16254592|NCT00976027|Biological|Trivalent inactivated influenza vaccine High Dose|0.5 mL, Intramuscular
16254593|NCT00976027|Biological|Trivalent inactivated influenza vaccine|0.5 mL, Intramuscular
16254594|NCT00976001|Other|Information, further rehabilitation, additional drugs to prevent recurrent stroke|
16254595|NCT00976001|Other|As the general practitioner wants to do|
16254596|NCT00975988|Drug|TYKERB® tablets|Patients administrated TYKERB® tablets according to the prescribing information
16254597|NCT00975975|Drug|Basiliximab|Basiliximab given 1 time on Day +7 or Day +9.
16254598|NCT00975962|Drug|Actilyse|Actilyse according to guidelines without pretreatment with remote persconditioning
16254599|NCT00975962|Procedure|Thrombolysis + remote perconditioning|The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC.
16254600|NCT00975949|Other|Survey|Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
16254601|NCT00975936|Drug|[14C]-GSK706769|50µg [14C]-GSK706769 containing 250 nCi
16254602|NCT00975936|Drug|Ketoconazole|200 mg Ketoconazole (Q12)
16254656|NCT00975611|Drug|Amantadine Hydrochloride, USP|amantadine tablets 100 mg. BID for 4 weeks
16254603|NCT00975923|Behavioral|Collaborative Group|"In addition to the Tool Kit materials and web site support, facility leaders and managers in this group agreed to participate in a Collaborative to improve critical care. The Collaborative differed from the IHI BTS model in that teams did not come together for face-to-face educational and planning sessions but instead attended web seminars and teleconferences. Between these virtual learning sessions, teams implemented some of the suggested change ideas, measured the results of those changes, and reported back to the larger group. Teams were supported through monthly educational and troubleshooting conference calls, individual coaching by faculty members, and an e-mail listserver designed to stimulate interaction among teams."
16254604|NCT00975923|Behavioral|Tool Kit|Hospitals received a tool kit:evidence-based guidelines, CLABSI/VAP fact sheets, change ideas,quality improvement and teamwork methods, standardized data collection and charting tools. Periodic reminders of their commitment to the Safe Critical Care Initiative and access to web site containing all of the educational seminars, clinical tools, and quality improvement tools. ICUs in this group were on their own to initiate and implement a local hospital quality improvement initiative preventing CLABSI and VAP.
16254605|NCT00975910|Drug|lidocaine|Lidocaine arm: lidocaine (2%) as an intravenous bolus (1.5 mg/kg) during induction followed by an intravenous infusion (2 mg. kg(-1).h(-1)) after induction until at the end of surgery
16254606|NCT00975910|Drug|saline|Saline arm: infused at the same rate as lidocaine
16254607|NCT00975897|Biological|bevacizumab|
16254608|NCT00975897|Biological|cetuximab|
16254609|NCT00975897|Drug|fluorouracil|
16254610|NCT00975897|Drug|irinotecan hydrochloride|
16254611|NCT00975897|Drug|leucovorin calcium|
16254612|NCT00975897|Drug|oxaliplatin|
16254613|NCT00975897|Genetic|RNA analysis|
16254614|NCT00975897|Genetic|cytogenetic analysis|
16254615|NCT00975897|Genetic|fluorescence in situ hybridization|
16254616|NCT00975897|Genetic|gene expression analysis|
16254617|NCT00975897|Genetic|mutation analysis|
16254618|NCT00975897|Genetic|protein expression analysis|
16254619|NCT00975897|Other|diagnostic laboratory biomarker analysis|
16254620|NCT00975897|Other|immunohistochemistry staining method|
16254621|NCT00975897|Other|questionnaire administration|
16254622|NCT00975897|Procedure|cognitive assessment|
16254623|NCT00975884|Biological|GSK investigational vaccine GSK2340272A|Two intramuscular injections
16254624|NCT00975858|Procedure|Coronary Revascularization|revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
16254625|NCT00975845|Other|BioCleanse Tibialis tendon|Outcomes of anterior cruciate replacement will be evaluated
16254626|NCT00975819|Drug|sirolimus|liquid dosing based on trough levels
16254627|NCT00975806|Drug|Lenalidomide|Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
16254628|NCT00975806|Drug|Sunitinib|Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
16254629|NCT00975793|Other|Early Goal Directed Therapy (EGDT)|Randomised allocation of early goal-directed therapy (EGDT). EGDT involves treatment with intravenous fluids, and medications to support the blood pressure and heart following a protocol. A special catheter is inserted to monitor central blood oxygen levels and the standard treatments are given according to the blood oxygen level reading. EGDT is given for 6 hours, then the patient receives standard care.
16254630|NCT00975780|Other|Enhanced Oral Care|oral brushing plus oral chlorhexidine plus upright feeding positioning
16254631|NCT00975780|Other|Usual oral care|Usual oral care and feeding positioning
16254632|NCT00975767|Drug|MGCD265+erlotinib|MGCD265 and erlotinib administered daily
16254633|NCT00975767|Drug|MGCD265+docetaxel|MGCD265 administered daily; docetaxel administered once every 3 weeks
16254634|NCT00975754|Drug|Pulmicort pMDI HFA|Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
16254635|NCT00975754|Drug|Budesonide pMDI HFA|Inhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
16254636|NCT00975754|Drug|Pulmicort Repulses|Suspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
16254637|NCT00975754|Drug|Pulmicort Turbohaler|Inhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
16254638|NCT00975741|Device|OXIMAX|
16254639|NCT00975741|Device|ASMANEX TWISTHALER|
16254640|NCT00975728|Dietary Supplement|Alixir - Pomegranate, apple and Açai drink / Placebo|250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
16254641|NCT00975715|Drug|TRI476|TRI476 oral suspension doses, based on body weight twice daily
16254642|NCT00975715|Drug|Placebo to TRI476|Placebo oral suspension, taken twice daily
16254643|NCT00975715|Drug|Benzodiazepines|Benzodiazepines could be used as needed as rescue medication during the duration of the study.
16254644|NCT00975702|Procedure|RIPC by Inflation of Pneumatic Tourniquet|Pneumatic tourniquets will be placed on both lower extremities in all deceased donor subjects. In the RIPC group the tourniquets will be inflated sequentially for 10 min each followed by deflation, approximately, 30-60 min prior to aortic crossclamping and organ perfusion.
16254645|NCT00975689|Drug|N-Acetyl Cysteine|900mg effervescent tablet; Dosed as 15 mg/kg/day (maximum dose 900 mg per day) for one week, advanced to 30 mg/kg/day (maximum dose 1800 mg per day) for the second week, and then advanced to 60 mg/kg/day (maximum dose 2700 mg) for the remainder of the trial (6 additional weeks).
16254647|NCT00975663|Drug|Tacrolimus and MMF|Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
16254648|NCT00975663|Drug|Tacrolimus and MMF|Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
16254649|NCT00975650|Drug|Nasobol®|Intra-nasal Testosterone (2 syringes), b.i.d.
16254650|NCT00975650|Drug|Androderm® (Positive Control)|QD administration
16254651|NCT00975637|Drug|70 mg SC|70 mg SC
16254652|NCT00975637|Drug|210 mg SC|210 mg SC
16254653|NCT00975637|Drug|140 mg SC|140 mg SC
16254654|NCT00975637|Drug|280 mg SC|280 mg SC
16254657|NCT00975611|Drug|Amantadine Hydrochloride, USP|amantadine 200 mg. tablets BID for 4 weeks
16254658|NCT00975611|Drug|Placebo|tablets BID, for 4 weeks
16254659|NCT00975585|Device|senofilcon A|soft contact lens, 2-week replacement indicated
16254660|NCT00975585|Device|lotrafilcon B|soft contact lens with a 4-week replacement indicated.
16254661|NCT00975572|Biological|split-virion, non-adjuvanted H1N1 vaccine of 30 μg|440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.
16254662|NCT00975572|Biological|Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg|440 participants (110 elders,110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.
16254663|NCT00975572|Biological|Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg|440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.
16254664|NCT00975572|Biological|Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg|330 participants (110 elders, 110 adults, and 110 adolescents) to receive split-virion, adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.
16254665|NCT00975572|Biological|Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg|440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.
16254666|NCT00975572|Biological|Placebo Comparator: Placebo control|110 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21.
16254667|NCT00975546|Other|Sperm washing and testing for HIV contamination|Semen will undergo specialized washing to reduce viral contamination of sperm. The sperm are first separated from leukocytes and other seminal constituents by centrifugation over a stepwise gradient. Motile sperm will be separated from the resulting pellet by a swim-up step in which washed sperm are overlaid with fresh medium into which sperm migrate. The final sperm suspension will be stored while testing for HIV is performed by reverse transcription polymerase chain reaction (RT-PCR)
16254668|NCT00975546|Procedure|Intrauterine Insemination|Intrauterine Insemination (IUI) will be performed on the HIV-negative wife, following standard clinical practice, using washed sperm from her HIV-positive husband after testing the IUI sample for HIV.
16254669|NCT00975533|Device|Tantalus|The TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM.
16254670|NCT00975533|Drug|Insulin|Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
16254671|NCT00975520|Other|Observation|Patients will be observed after surgery until recurrence when they will be offered radiation therapy
16254672|NCT00975520|Radiation|Radiation Therapy|Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local recurrence. The recommended dose prescribed is 48 Gy in 20 fractions over 4 weeks.
16254673|NCT00975507|Biological|Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
16254674|NCT00975507|Biological|Comparator: Placebo|a single 0.5 mL subcutaneous placebo injection at Day 0
16254675|NCT00975507|Biological|Comparator: Varivax|a single 0.5 mL subcutaneous injection of Varivax at Day 0
16254676|NCT00975507|Biological|Comparator: M-M-R II|a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
16254677|NCT00975494|Drug|Sildenafil|
16254678|NCT00975494|Drug|Placebo|
16254679|NCT00975481|Drug|dimebon|Oral tablet; 20 mg dimebon, single dose
16254680|NCT00975481|Drug|dimebon|Oral tablet; 40 mg dimebon, single dose
16254681|NCT00975481|Drug|dimebon|Oral tablet; 60 mg dimebon, single dose
16254682|NCT00975481|Drug|placebo|Oral tablet or capsule; placebo, single dose
16254683|NCT00975481|Drug|alprazolam|Oral capsule; 1 mg alprazolam, single dose
16254684|NCT00975481|Drug|alprazolam|Oral capsule; 3 mg alprazolam, single dose
16254685|NCT00975468|Other|Pressure Controlled vs. Volume Controlled Ventilation during OLV|Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.
16254686|NCT00975442|Other|Eccentric training|A home training program of eccentric training of the wrist extensors to be carried out daily with 3 sets of 15 repetitions. All subjects were instructed to use the forearm band (Epi Forsa 4061, Rehband, Sweden)
16254687|NCT00975442|Device|Forearm band|All subjects were instructed to use the forearm band during all daily activities.
16254688|NCT00975442|Device|Forearm band|All patients were instructed to use a forearm band during all daily activities.
16254689|NCT00975429|Drug|WST11|The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 4mg/kg using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.
16254690|NCT00975429|Drug|WST11|The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 6mg/kg in patients using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm ) and light energy (200J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.
16254691|NCT00975416|Behavioral|Cognitive Behavioral Therapy|Intranasal oxytocin given in the context of cognitive behavioral therapy
16254692|NCT00975416|Drug|Intranasal Oxytocin|Intranasal oxytocin given in the context of cognitive behavioral therapy
16254693|NCT00975416|Drug|Placebo|Placebo given in the context of cognitive behavioral therapy
16254821|NCT00974571|Drug|Comparator: placebo|placebo tablet orally once daily at bedtime for 6 weeks
16254694|NCT00975403|Device|Dead space breathing|Chemical loading by adding a deadspace (600ml) to the breathing circuit during a single cycle exercise test
16254695|NCT00975403|Device|Room air breathing|Sham comparator (vs deadspace) during a single cycle exercise test will entail breathing room air on the same circuit without the rebreathe valves
16254696|NCT00975390|Dietary Supplement|Carbohydrate|1.2 g/kg/h
16254697|NCT00975390|Dietary Supplement|Carbohydrate and protein ingestion|1.2 g/kg/h carbohydrate plus 0.4 g/kg/h protein
16254698|NCT00975390|Dietary Supplement|Carbohydrate and caffeine ingestion|1.2 g/kg/h carbohydrate and 1.67 g/kg/h caffeine
16254699|NCT00975377|Procedure|Hair clipping|Patients randomized to the hair clipping cohort will be clipped using an Allegiance 4413 hair clipper. Hair removal will occur on the day of surgery by one of the preoperative nursing staff, immediately prior to the scheduled operation.
16254700|NCT00975351|Dietary Supplement|13C5-labelled 5-methyltetrahydrofolic acid|"one intravenous bolus dose of no more than 500nmole 13C5-labelled 5-methyltetrahydrofolic acid, followed by multiple blood samplings at regular time intervals. Total 2hr intervention."
16254701|NCT00975338|Other|LIFEspan|Rehabilitation services provided by an inter-disciplinary team of health professionals addressing the transfer of care to adult services and emerging needs related to transition to adulthood. LIFEspan staff are cross-appointed to both a pediatric and an adult hospital through a formally linked model of care.
16254702|NCT00975338|Other|Non-LIFEspan|Standard of care in the absence of a formal partnership between a pediatric and an adult hospital.
16254703|NCT00975325|Drug|Yohimbine|yohimbine 5 mg, one tablet, single dose only
16254704|NCT00975325|Drug|Yohimbine|yohimbine 5 mg, one tablet, single dose only
16254705|NCT00975312|Drug|Triple combination cream|The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand once daily for up 12 weeks.
16254706|NCT00975312|Drug|Tretinoin 0.05%|Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.
16254707|NCT00975299|Drug|BAY86-4367|Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT
16254708|NCT00975299|Drug|BAY86-4367|Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 in blood
16254709|NCT00975286|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16254710|NCT00975286|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16254711|NCT00975286|Drug|Insulin glargine|Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
16254712|NCT00975286|Device|Pen auto-injector|Lantus® SoloStar® OptiClik®
16254713|NCT00975286|Drug|Metformin|Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
16254714|NCT00975286|Drug|Thiazolidinedione (TZD)|TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
16254715|NCT00975273|Behavioral|Capnometry Assisted Respiration Training|Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device.
16254716|NCT00975273|Behavioral|Breathing Awareness|Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.
16254717|NCT00975247|Other|Receiving an educational booklet|Patients who receive an educational booklet will be considered to be receiving an intervention
16254718|NCT00975234|Procedure|Intra-lesion injection of autologous skeletal myoblasts|Intra-lesion injection
16254719|NCT00975234|Procedure|Revascularisation|Revascularisation surgery
16254720|NCT00975221|Drug|Cinacalcet|Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID).
16254721|NCT00975221|Drug|Placebo|Administered orally following the same tiitration regimen as the experimental arm.
16254722|NCT00975195|Drug|tiotropium inhalation|
16254723|NCT00975195|Drug|salmeterol xinafoate|
16254724|NCT00975195|Drug|fluticasone propionate|
16254725|NCT00975195|Drug|placebo matched for fluticasone propionate|
16254726|NCT00975182|Drug|GDC-0941|Oral repeating dose
16254727|NCT00975182|Drug|erlotinib HCl|Oral repeating dose
16254728|NCT00975156|Other|Physical Therapy|Conventional physical therapy
16254729|NCT00975156|Device|Lokomat|Robotic-assisted walking device
16254730|NCT00975143|Drug|CIP-Isotretinoin|0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
16254731|NCT00975143|Drug|Isotretinoin|0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
16254732|NCT00975130|Biological|SC golimumab|Subcutaneous golimumab at a dose of 50 mg administered once monthly.
16254733|NCT00975130|Biological|IV golimumab|Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.
16254734|NCT00975117|Dietary Supplement|Placebo|One Placebo tablet (Orally administered) twice a day, for 12 weeks.
16254735|NCT00975117|Dietary Supplement|Spermotrend|One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
16254736|NCT00975104|Drug|AMG 745 0.3 mg/kg|AMG 745 0.3 mg/kg IV QW
16254737|NCT00975104|Drug|AMG 745 1.0 mg/kg|AMG 745 1.0 mg/kg IV QW
16254738|NCT00975104|Drug|AMG 745 3.0 mg/kg|AMG 745 3.0 mg/kg IV QW
16254739|NCT00975104|Drug|Placebo|Placebo IV QW
16254740|NCT00975091|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
16254741|NCT00975091|Drug|Entecavir|Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
16254822|NCT00974558|Device|handheld fan directed to cheeks|Handheld fan directed to cheeks for 5 minutes
16254823|NCT00974532|Dietary Supplement|High calcium diet 2000 mg/day|High calcium (2000 mg elemental calcium) diet x 9 days
16254742|NCT00975078|Procedure|adrenal insufficiency testing|"On the day getting the baseline data we will perform a low dose cosyntropin test to asses adrenal axis function.
~All participants will then undergo an overnight 0.5mg dexamethasone suppression test. Thereby participants will take 0.5mg of dexamethasone at 11 pm and a fasting blood sample will be collected the next morning at 8 am to measure the serum cortisol level.
~Six days later participants will start taking 0.5mg/kg body-weight prednisone each morning for 14 days.
~On day 1, 3, 7 and 21 after withdrawal of prednisone the participant will undergo a low dose cosyntropin test. The investigators will take a blood sample before and 30 minutes after i.v. administration of 1ug of cosyntropin for the measurement of cortisol."
16254743|NCT00975078|Drug|prednisone|0.5mg/kg body-weight prednisone each morning for 14 days
16254744|NCT00975065|Drug|vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)|vildagliptin 50 mg bid plus metformin 1500mg
16254745|NCT00975065|Drug|metformin 1500mg plus metformin 500mg or 1000mg (Diabex)|metformin 1500mg plus metformin 500mg or 1000mg
16254746|NCT00975052|Drug|sitagliptin phosphate|100 mg sitagliptin daily for two days in one out of four treatment periods
16254747|NCT00975052|Drug|Comparator: metformin|500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.
16254748|NCT00975052|Drug|Comparator: sitagliptin and metformin|100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.
16254749|NCT00975052|Drug|Comparator: placebo|Placebo only on Days 1 and 2 in one of four treatment periods.
16254750|NCT00975039|Drug|WST11|WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2.5 and 5 mg/kg, using 753nm laser light at a fixed power (150 mW/cm) and light energy (200 J/cm). Illumination in the bile duct is performed by inserting a diffusing fiber, with cylindrical uniform light distribution, in a transparent standard ERCP catheter and by positioning, under radioscopy, the illumination tip of the diffusing fiber in front of the lesion.
16254751|NCT00975026|Procedure|Massages ± Stretches|Chair Massage
16254752|NCT00975000|Drug|Cinacalcet|Possible sequential doses are 30, 60, 90, 120, and 180 mg.
16254753|NCT00975000|Drug|Placebo|Administered orally following the same dosing regimen as the experimental arm.
16254754|NCT00974987|Radiation|BNCT(boron neutron capture therapy)|BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.
16254755|NCT00974987|Radiation|XRT(X-ray radiation treatment)|After BNCT, 2Gy irradiation every day for 12 days.
16254756|NCT00974987|Drug|TMZ(temozolomide)|75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.
16254757|NCT00974974|Drug|IPX066|extended-release carbidopa-levodopa capsules
16254758|NCT00974974|Drug|IR CD-LD|immediate-release carbidopa-levodopa tablets
16254759|NCT00974961|Drug|bupivacaine, levobupivacaine|intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once
16254760|NCT00974948|Procedure|EUS-guided celiac plexus neurolysis|Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
16254761|NCT00974935|Drug|Aluminum hydroxide|Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.
16254762|NCT00974935|Biological|STEBVax vaccine|Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.
16254763|NCT00974922|Drug|Aliskiren|150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
16254764|NCT00974922|Dietary Supplement|Cholecalciferol|3000 I.U. once daily for 6 weeks
16254765|NCT00974922|Dietary Supplement|Placebo|Placebo for two weeks
16254766|NCT00974909|Device|Urgent PC neuromodulation system|Urgent PC neuromodulation system
16254767|NCT00974909|Device|Urgent PC neuromodulation system|Urgent PC neuromodulation system (sham)
16254768|NCT00974896|Drug|AMG 479|AMG 479 is a fully human IgG1 monoclonal antibody that inhibits IGF-1R signalling. AMG 479 (6mg/kg or 12mg/kg) will be given IV every 2 weeks in combination with sorafenib (400 mg po BID) or erlotinib (150 mg po QD).
16254769|NCT00974883|Procedure|Ultrasound of temporal and axillary arteries|Standardised assessment of temporal arteries and axillary arteries using high resolution ultrasound to detect halo, stenosis or occlusion
16254770|NCT00974883|Procedure|Temporal artery biopsy|Biopsy of temporal artery from symptomatic side
16254771|NCT00974870|Procedure|needling treatment|Needling treatment applied to half of the face at each study visit
16254772|NCT00974857|Device|BCM|Overhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session.
16254773|NCT00974857|Other|control group|BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
16254774|NCT00974831|Other|Amino Acid Drink Mixture|22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
16254775|NCT00974831|Other|Glucose drink|22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
16254776|NCT00974818|Drug|Mitomycin C (MMC)|Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
16254824|NCT00974532|Dietary Supplement|Low calcium diet, 800 mg/day|Low calcium (800 mg elemental calcium) diet x 9 days
16254990|NCT00973271|Drug|Placebo|Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
16254991|NCT00973271|Drug|atorvastatin|20 mg atorvastatin
16254777|NCT00974818|Biological|Bacillus Calmette-Guerin (BCG)|Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
16254778|NCT00974805|Drug|Seretide 500 Accuhaler|Seretide 500 accuhaler one inhalation BD
16254779|NCT00974792|Biological|pegfilgrastim|
16254780|NCT00974792|Biological|rituximab|
16254781|NCT00974792|Drug|cyclophosphamide|
16254782|NCT00974792|Drug|cytarabine|
16254783|NCT00974792|Drug|doxorubicin hydrochloride|
16254784|NCT00974792|Drug|etoposide phosphate|
16254785|NCT00974792|Drug|ifosfamide|
16254786|NCT00974792|Drug|leucovorin calcium|
16254787|NCT00974792|Drug|methotrexate|
16254788|NCT00974792|Drug|vincristine sulfate|
16254789|NCT00974779|Device|HCO1100 dialyzer|Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks
16254790|NCT00974779|Device|regular dialysis polyamide|Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
16254791|NCT00974766|Drug|Glucocorticoids|Prednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue
16254792|NCT00974766|Drug|Glucocorticoids|Prednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue
16254793|NCT00974753|Drug|Ketorolac 0.5%|Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
16254794|NCT00974753|Other|Saline drops|Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
16254795|NCT00974740|Drug|Atorvastatin|atorvastatin 40 mg (tablet for oral intake) once daily in the evening for 4 weeks, thereafter 80 mg for the remaining treatment period (total treatment period 18 months)
16254796|NCT00974740|Drug|atorvastatin matching placebo|atorvastatin matching placebo tablets once daily in the evening, corresponding to 40 mg atorvastatin for the first 4 weeks (run-in period), and corresponding to 80 mg atorvastatin thereafter (total treatment period 18 months)
16254797|NCT00974727|Other|Garden Fit|8-week summer gardening program. 9am-12pm on Monday, Wednesday, Friday and 9am-12:30pm on Tuesday and Thursday. Activities included gardening (preparing soil for planting, planting seeds and seedlings, mulching, weeding, watering, and harvesting), preparing meals with fresh foods from the garden, and other garden activities and games.
16254798|NCT00974714|Drug|L-arginine|Oral L-arginine 2 g twice a day for 14 weeks
16254799|NCT00974714|Other|placebo|oral placebo 2 g twice a day for 14 weeks
16254800|NCT00974701|Device|PillCam ESO2|The capsule to be tested in this proposed study, PillCam ESO 2 capsule Endoscopy, is an improved version with exactly the same dimensions as the current PillCam ESO capsule, both in length and diameter.
16254801|NCT00974688|Behavioral|Information Intervention|The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child. The information intervention will be comprised of discussions and written information.
16254802|NCT00974688|Behavioral|Demonstration Intervention|The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities. The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.
16254803|NCT00974675|Biological|CAT-354 1mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
16254804|NCT00974675|Biological|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
16254805|NCT00974675|Biological|CAT-354 10mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
16254806|NCT00974675|Other|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
16254807|NCT00974662|Drug|WST11|WST11-mediated VTP will consists of the combination of a single IV administration of WST11 at doses of 5, 7.5 & 10 mg/kg, using 753 nm laser light at a fixed power of 250 mW/cm and escalating fixed energy dose (200 Joules/cm and 300 Joules/cm) locally delivered to the obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope operating channel with visual control, possibly video-transmission assisted. The fiber illuminating diffusion length is fixed (2 cm).
16254808|NCT00974649|Behavioral|self-report questionnaire|validated self-report questionnaires on psychosocial determinants
16254809|NCT00974636|Dietary Supplement|Low Salt Diet|Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day
16254810|NCT00974636|Dietary Supplement|Usual Salt Diet|Usual salt intake (approximately >180-200 mmol/day in the average American diet).
16254811|NCT00974623|Device|Bone graft substitute, autograft or allograft|spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
16254812|NCT00974597|Device|AWBAT™-D and Mepilex® Ag dressings|Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.
16254813|NCT00974584|Drug|GDC-0941|The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n
16254814|NCT00974584|Drug|bevacizumab|Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.
16254815|NCT00974584|Drug|carboplatin|Carboplation IV on Day 1 of every 3-week cycle, at a dose to achieve an area under concentration time curve of 6 milligrams per milliliter*minute (mg/mL*min).\n
16254816|NCT00974584|Drug|cisplatin|Cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of every 3-week cycle.\n
16254817|NCT00974584|Drug|paclitaxel|Paclitaxel 200 mg/m^2 IV on Day 1 of every 3-week cycle.\n\n
16254818|NCT00974584|Drug|pemetrexed|Pemetrexed 500 mg/m^2 IV on Day 1 of every 3-week cycle.
16254819|NCT00974571|Drug|montelukast sodium|montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
16254820|NCT00974571|Drug|Comparator: cetirizine|cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
16254825|NCT00974519|Drug|Fuzheng 3|"Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
~Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days."
16254826|NCT00974519|Drug|Fuzheng 1|"Immunity 1 (Fuzheng 1), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
~Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days."
16254827|NCT00974519|Drug|Placebo|"Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
~Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days."
16254828|NCT00974506|Other|CAM-intervention|Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner
16254829|NCT00974506|Other|Routine care therapy|Routine care therapy by general practitioner
16254830|NCT00974493|Drug|Antibiotics|"The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.
~Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."
16254831|NCT00974480|Other|Redermic|Cosmetic cream formulation 609637 43.
16254832|NCT00974480|Drug|Tretinoin (Rejuva-A)|Tretinoin 0.025% cream.
16254833|NCT00974467|Behavioral|After The Injury website|Parents participate in a web-based prevention intervention, which provides education and tips specific to coping with a child's injury.
16254834|NCT00974467|Other|Control|Usual hospital care provided.
16254835|NCT00974454|Drug|Fuzheng 2|Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
16254836|NCT00974454|Drug|Placebo|Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
16254837|NCT00974441|Drug|Divalproex Sodium|500 mg Extended Release Tablet
16254838|NCT00974441|Drug|Depakote®|500 mg Extended Release Tablet
16254839|NCT00974428|Dietary Supplement|Wobenzym® N|4 tablets TID, 6 weeks
16254840|NCT00974428|Dietary Supplement|Placebo|4 tablets TID
16254841|NCT00974415|Procedure|CO2|CO2 treatment delivered to randomized flank at each study visit
16254842|NCT00974415|Procedure|Sham|Sham treatment to other flank at each study visit
16254843|NCT00974402|Behavioral|Cognitive Behavioral Therapy|The study investigators have developed a 4-session PTSD treatment plan including a behavioral health consultants (BHC) manual and a patient guide for use in primary care. Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. The study will adapt intervention methods for use in the time-constrained primary care environment from Cognitive Behavioral Therapy(ies) that have proven effective for PTSD in specialty mental health care settings. Study participants will receive four 30-minute treatment sessions over six weeks.
16254844|NCT00974389|Biological|bevacizumab|
16254845|NCT00974389|Drug|tegafur-gimeracil-oteracil potassium|
16254846|NCT00974376|Drug|gabapentin 1200mg/day|gabapentin 1200mg/day for 12 weeks
16254847|NCT00974376|Drug|Placebo|1200mg/day of placebo for 12 weeks
16254848|NCT00974376|Behavioral|Manual-guided behavioral counseling|Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
16254849|NCT00974363|Procedure|Blood Sampling|A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
16254850|NCT00974350|Drug|SABER-Bupivacaine|Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
16254851|NCT00974350|Drug|SABER-Bupivacaine|Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
16254852|NCT00974350|Drug|SABER-Placebo|Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
16254853|NCT00974324|Drug|endostar and CHOP|"endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks
~CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone"
16254854|NCT00974311|Drug|Enzalutamide|MDV3100, 160 mg orally per day
16254855|NCT00974311|Drug|Placebo|Placebo comparator
16254856|NCT00974298|Procedure|Total elbow replacement arthroplasty|Total elbow arthroplasty using pressfit technique in which no cement is used.
16254857|NCT00974285|Drug|Fuzheng 1|Immunity 1 (Fuzheng 1), 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
16254858|NCT00974285|Drug|Placebo|Placebo, 8.75g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
16254859|NCT00974272|Drug|Exenatide|Single subcutaneous injection (10 μg)
16254860|NCT00974272|Other|Normal Saline|Single subcutaneous injection
16254861|NCT00974259|Device|Management protocol based on pBrO2 and ICP values.|For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (> 20 mm Hg) or pBrO2 (< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time.
16254862|NCT00974259|Device|Management protocol based on ICP values only.|For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant.
16254863|NCT00974246|Drug|Advair diskus|Advair diskus 50/250 1 inhalation bid for 16 weeks
16254864|NCT00974233|Drug|Bendamustine|90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
16254865|NCT00974233|Drug|Rituximab|375 mg/m2 Day 1 every 28 days for 6 cycles
16254866|NCT00974233|Drug|Lenalidomide|5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
16254867|NCT00974220|Drug|fentanyl|single dose, 50 mcg of nebulized fentanyl citrate
16254868|NCT00974220|Drug|normal saline (placebo)|single dose, 0.9% saline solution
16254869|NCT00974194|Procedure|Single Trocar CCK|CCK using Triport
16254870|NCT00974194|Procedure|Standard CCK|CCK using three or four ports
16254871|NCT00974181|Device|Conor Medsystems COSTAR™ stent (10 µg Paclitaxel)|Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (10 µg Paclitaxel)
16254872|NCT00974181|Device|Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)|Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (30 µg Paclitaxel)
16254873|NCT00974168|Radiation|Cumulative BED ≤ 100|Radiation
16254874|NCT00974168|Radiation|Cumulative BED ≤ 130 Gy2|Radiation
16254875|NCT00974155|Drug|Escitalopram, venlafaxine, lithium|oral application, highest tolerable dose, once daily
16254876|NCT00974155|Drug|Escitalopram, venlafaxine|oral application, highest tolerable dose, once daily
16254877|NCT00974142|Drug|Cyclosporine|Fifteen patients will receive cyclosporine at an initial dosing of 3.0 mg/kg/day.
16254878|NCT00974142|Drug|Placebo|Fifteen patients will receive will receive placebo.
16254879|NCT00974116|Behavioral|MEND Childhood Obesity Program|The number of children who are obese in the UK is steadily increasing with both short and long term consequences for health. The aim of this study is to determine whether the MEND Programme (a new national initiative for the treatment of childhood obesity) is a successful and sustainable treatment for childhood obesity and obesity related health problems.
16254880|NCT00974116|Behavioral|Control Group|No intervention
16254881|NCT00974103|Other|exercise advise|Exercises
16254882|NCT00974103|Other|chiropractic treatment and exercises|Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments
16254883|NCT00974090|Drug|Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
16254884|NCT00974090|Drug|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
16254885|NCT00974077|Behavioral|Mindfulness Based Cognitive Therapy|Group treatment over 8 weeks with training in meditation, stress regulation, shift attention, stay present, in addition with cognitive and behavioral strategies (following Williams et al. Manual 2002)
16254886|NCT00974077|Other|Waiting List Control|Patients receive MBCT with a delay of 6 months.
16254887|NCT00974051|Drug|Terbutaline|Oral (2.5mg) one time administration at 9:00pm
16254888|NCT00974051|Other|20% basal insulin reduction|Basal insulin rate is reduced by 20% the normal (home dose) for six hours.
16254889|NCT00974051|Other|Control|No treatment is given for the study. This arm is for comparison with the two intervention arms.
16254890|NCT00974038|Behavioral|psychotherapy|1) cognitive-behavioral therapy or 2) supportive psychotherapy
16254891|NCT00974025|Dietary Supplement|Vitamin C|High-dose Vitamin C will be administered in 4 age-based dosing groups
16254892|NCT00974025|Dietary Supplement|Placebo|Placebo will be administered twice daily for four weeks
16254893|NCT00974012|Drug|Divalproex Sodium|500 mg ER Tablet
16254894|NCT00974012|Drug|Depakote®|500 mg ER Tablet
16254895|NCT00973999|Drug|Botulinum Toxin|"Each parotid salivary gland will be injected with 75MU of Botulinum Toxin type-A, 0.15mls in total, with 0.09mls into the mass of the gland and another 0.06mls into the adjacent part above the masseter muscle, using a 1ml syringe and a 30 gauge needle.
~Each submandibular salivary gland will be injected with 15MU of Botulinum Toxin A, administering 0.03mls, using a 1ml syringe and a 30 gauge needle."
16254896|NCT00973986|Drug|Atorvastatin|The subjects will receive atorvastatin (20 mg single dose) orally with approximately 240 ml of water. Blood samples(4 mL) will be taken prior to dosing and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24 and 48 h after drug administration.
16254897|NCT00973973|Drug|Placebo|Matching placebo tablets taken orally once a day
16254898|NCT00973973|Drug|Elagolix|Immediate release (IR) tablets taken orally once a day
16254899|NCT00973947|Other|questionnaire administration|
16254900|NCT00973947|Radiation|3-dimensional conformal radiation therapy|
16254901|NCT00973947|Radiation|radiation therapy treatment planning/simulation|
16254902|NCT00973934|Device|Magstim Theta|
16254903|NCT00973934|Device|Thymatron System IV|
16254904|NCT00973908|Drug|VSL#3|Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
16254905|NCT00973908|Drug|Placebo|Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
16254906|NCT00973895|Biological|VRC-FLUDNA057-00-VP|DNA Vaccine Expressing H1 HA from Influenza A/California/04/2009 H1N1 Virus
16254907|NCT00973882|Drug|Carboplatin|Carboplatin AUC4 on day 1 repeated every 3 weeks for a maximum of 6 cycles
16254908|NCT00973882|Drug|Etoposide|Etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles
16254909|NCT00973869|Dietary Supplement|curcumin|
16254910|NCT00973869|Other|high performance liquid chromatography|
16254911|NCT00973869|Other|laboratory biomarker analysis|
16254912|NCT00973869|Other|pharmacological study|
16254913|NCT00973869|Procedure|diagnostic endoscopic procedure|
16254914|NCT00973869|Procedure|therapeutic conventional surgery|
16254915|NCT00973856|Other|PURELL VF481|One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
16254985|NCT00973284|Biological|mannitol and sucrose|Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder
16254916|NCT00973856|Other|Placebo Solution|One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
16254917|NCT00973830|Other|Diabetes Guide and Brief Counseling|If in one of the intervention arms, patients will receive a Diabetes Guide (a patient-friendly guide to help patients make healthy changes to improve their diabetes). The Diabetes Guide includes a brief counseling component, to be conducted with clinic staff (Carve-In) or an outside diabetes educator (Carve-Out).
16254918|NCT00973817|Biological|ELAD plus standard of care treatment|Use of ELAD plus standard of care
16254919|NCT00973817|Other|Standard of care|Standard of care in the treatment of AOCH will be administered
16254920|NCT00973804|Drug|EPOCH-F/R|
16254921|NCT00973804|Drug|FLAG|
16254922|NCT00973804|Drug|Transplant Preparative Regimen (Flu/Cy/Mes)|
16254923|NCT00973804|Drug|GVHD Prophylaxis (tacrolimus and sirolimus)|
16254924|NCT00973804|Procedure|Double Cord Blood Transplantation|
16254925|NCT00973791|Drug|Ringer's Lactate|Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
16254926|NCT00973791|Drug|Six percent hydroxyethyl starch|Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
16254927|NCT00973778|Other|Preoperative Chemoradiotherapy|Patient will receive pre-operative radiotherapy with intensity modulated radiotherapy to primary and any grossly enlarged pelvic nodes 5Gy in 5 fractions over 5 days with concurrent capecitabine 1500mg p.o. bid for 1 week, then undergo surgery.
16254928|NCT00973765|Drug|bactrim|bactrim DS (800/160) 2 pills PO BID x 7 days
16254929|NCT00973765|Drug|placebo|placebo 2 pills po BID x 7 days
16254930|NCT00973752|Drug|Prednisone|Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
16254931|NCT00973752|Drug|Vincristine|Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
16254932|NCT00973752|Drug|Doxorubicin|Intravenously during Induction, CNS, and Consolidation 2 therapy
16254933|NCT00973752|Drug|PEG-asparaginase|Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
16254934|NCT00973752|Drug|Cytarabine|Intrathecally during Induction and CNS therapy
16254935|NCT00973752|Drug|Methotrexate|Intrathecally during Induction, CNS, and Continuation Therapy
16254936|NCT00973752|Drug|Imatinib|Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
16254937|NCT00973752|Drug|Clofarabine|Intravenously during Consolidation 1 Therapy
16254938|NCT00973752|Drug|6 Mercaptopurine|Orally during CNS, Consolidation 2 and Continuation Therapy
16254939|NCT00973739|Drug|Lapatinib|"Lapatinib is dosed according to age. Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.
~Children/adolescents (<18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO (3 tablets twice daily)
~Adults (>=18 years of age): 1,500 mg PO (6 tablets once daily)
~Duration: Up to 12 months, depending on treatment response."
16254940|NCT00973726|Other|Glucose test|Subjects ingest an oral glucose tolerance test.
16254941|NCT00973713|Drug|RAD001|10mg/d
16254942|NCT00973700|Biological|MF59-eH1N1_f|MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
16254943|NCT00973700|Biological|eH1N1_f|Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
16254944|NCT00973687|Drug|Ora Sweet|A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.
16254945|NCT00973687|Drug|Dexamethasone|
16254946|NCT00973674|Drug|Premarin IV|One time dose of Premarin IV
16254947|NCT00973674|Drug|Placebo|One time dose of Placebo
16254948|NCT00973661|Behavioral|Electronic tool set for counseling overweight patients|"Physicians randomized to the electronic tools arm will receive access to a tool set to aid with counseling of overweight patients. This tool set includes the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians randomized to the usual care arm will not receive access to these tools, and will continue to provide their usual care for overweight patients."
16254949|NCT00973635|Other|Web-based education|"Patients of subjects who were required to complete 10 web-based, independent learning modules. Each subject given a course packet which includes 13 required core articles pertaining to handoff skills. Each subject receives immediate feedback to each web-case with correct answers and suggested readings. Each subject given individualized feedback on their scores for summaries, instructions, and sign outs."
16254950|NCT00973622|Device|repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)|All participants will receive 90 10-pulse trains of 1 sec duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.
16254951|NCT00973622|Device|repetitive transcranial magnetic stimulation (rTMS) 20Hz|All participants will receive 45 20-pulse trains of 1 second duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.
16254952|NCT00973622|Device|SHAM repetitive transcranial magnetic stimulation (rTMS)|The look and sound of active rTMS is reproduced with the same coil used in the active conditions. The magnetic field in the sham coil is markedly attenuated at only 5% of stimulator output. The feel of active stimulation will be reproduced by delivering monophasic current pulses to the left, frontalis muscle with a Isolated Stimulator and two carbon rubber electrodes. Smokers will receive Sham rTMS in both the nicotine-satiated and nicotine-withdrawal conditions.
16254953|NCT00973609|Drug|5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab|"Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.
~Following induction treatment regimen (for maintenance treatment): No maintenance treatment."
16254954|NCT00973609|Drug|5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab|"Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.
~Following induction treatment regimen (for maintenance treatment): Fluoropyrimidine + Bevacizumab."
16254986|NCT00973284|Biological|Norwalk virus|Norwalk virus solution
16254987|NCT00973271|Drug|290 mg DCCR|290 mg diazoxide choline
16254955|NCT00973609|Drug|5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab|"Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab.
~Following induction treatment regimen (for maintenance treatment): Bevacizumab monotherapy."
16254956|NCT00973583|Dietary Supplement|vitamin D|vitamin D3 400 IU daily
16254957|NCT00973583|Dietary Supplement|placebo|placebo
16254958|NCT00973570|Behavioral|TABADO program|The intervention takes place in 3 stages: (i) a general information session on tobacco consumption is delivered to all teenagers, both smokers and nonsmokers. (ii) For smokers wishing to join the program, this session is followed by individualized consultations with a team of tobacco addiction physicians. (iii) The volunteers then benefit from a small group approach, consisting of discussion sessions to share experiences, strengthen motivation, and prevent relapse. There will be 4 sessions in total, comprising individual counseling and work in groups spread over 3 months (taking into account the availability of the trainees because of their alternate-week training schedule).
16254959|NCT00973544|Other|Cultures taken from the drain discharge|Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12. When drain is removed cultures of the drain tip are taken. Clinical signs of surgical signs infections will be observed.
16254960|NCT00973531|Device|Autotitrating Positive Airway Pressure (APAP)|Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
16254961|NCT00973531|Device|Traditional Split Titration Polysomnogram|Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
16254962|NCT00973505|Drug|Aromatase Inhibitor(Femara or Arimidex)|Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd
16254963|NCT00973492|Other|functional insulinotherapy class|"The functional insulinotherapy class lasts for 4 days. It is taught by 2 nurses, 2 dieticians and 2 physicians to 6 to 10 patients.
~On day 1, patients describe their difficulties with diabetes. Fast-acting insulin scales are elaborated from preprandial and postprandial blood glucose levels. At dinner, patients start a 24-hour glucose-fasting period to evaluate their need for basal insulin. Meals contain virtually no carbohydrates. Correcting doses of insulin are administered if preprandial glycemia is over 1.50 g/l or postprandial glycemia is over 2 g/l. Blood glucose levels must stay within normal values during the whole 24-hour period.
~Carbohydrate management is taught during meals and every afternoon through workshops about dietetics. Patients also learn how to deal with hypoglycaemia, hyperglycaemia and physical activity.
~A one-day follow-up takes place 3 months later."
16254964|NCT00973479|Drug|Golimumab|Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).
16254965|NCT00973479|Other|Placebo|Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.
16254966|NCT00973479|Drug|methotrexate (MTX)|Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.
16254967|NCT00973453|Drug|PURETHAL Mites 20,000 AUeq/ml|"Group 1: slow regimen (12+2 injections) Initial treatment: incremental weekly dose of 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml Additional maintenance: 2 two-weekly injections 2.0* ml
~*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm."
16254968|NCT00973453|Drug|PURETHAL Mites 20,000 AUeq/ml|"Group 2: intermediate regimen (9+2 injections) Initial treatment: incremental weekly dose of 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml.
~Additional maintenance: 2 two-weekly injections 2.0* ml
~*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm."
16254969|NCT00973453|Drug|PURETHAL Mites 20,000 AUeq/ml|"Group 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 1.2*, 1.6* and 2.0*ml.
~Additional maintenance: 2 two-weekly injections 2.0* ml
~*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm."
16254970|NCT00973414|Drug|Ringer's Lactate|Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section
16254971|NCT00973414|Drug|Six percent hydroxyethyl starch|Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section
16254972|NCT00973401|Other|Insulin pump|Patients receive an insulin pump that optimizes their glucose control.
16254973|NCT00973388|Drug|Telaprevir; Moxifloxacin; Placebo|
16254974|NCT00973362|Device|APTIMA HPV Assay|"The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
16254975|NCT00973362|Device|FDA-Approved HPV DNA Test|A FDA-Approved HPV DNA Test is used as the comparator assay.
16254976|NCT00973349|Biological|MF59-eH1N1_f|8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
16254977|NCT00973336|Drug|Calcium and vitamin D|1000mg calcium per day 800 IE vitamin D per day
16254978|NCT00973323|Drug|Xarelto (Rivaroxaban, BAY59-7939)|2.5mg bid
16254979|NCT00973323|Drug|Xarelto (Rivaroxaban, BAY59-7939)|5mg bid
16254980|NCT00973323|Drug|Xarelto (Rivaroxaban, BAY59-7939)|10mg bid
16254981|NCT00973323|Drug|Warfarin|Dose-adjusted warfarin based on target INR values
16254982|NCT00973310|Other|Radiation Therapy and EGFR-TKI target therapy|Patients with locally advanced NSCLC received oral erlotinib (150 mg, qd) for about 6-7 weeks during the course of radiation therapy (60-70Gy in a fraction dose of 2 Gy, 5 fractions per week)
16254983|NCT00973297|Other|Multidisciplinary falls prevention|Group education on falls risk and mobility and transfers safety; Physical therapy at the subjects' bedside consisting of balance training; Medical assessment - medications use (anxiolytics/hypnotics, neuroleptics, antihypertensives, antiarrhythmics and other vasodilators) with effort to discontinue or reduce dose when possible; orthostatic hypotension - discontinue/reduce dose of related medications; urinary frequency/incontinence - evaluation and treatment; delirium - evaluation and treatment; visual pathology - evaluation and treatment
16254984|NCT00973284|Biological|Norwalk VLP vaccine|Norwalk VLP vaccine dry powder
16254992|NCT00973258|Dietary Supplement|Nutritional Intervention|Each subject in the nutritional intervention group is provided with a commercial liquid formula (Fortisip Multi Fibre, Nutricia), which should be taken every evening for a period of 24 weeks. Subjects are also given one capsule of iron and folate supplement (Sangobion, Merck; consisting of 1 mg folate and 29mg iron), one capsule of Vitamin B6 and vitamin B12 supplement (Neuroforte; consisting of 200mcg B12 and 200mg vit B6) and one tablet of Caltrate with Vitamin D (consisting of 200 IU vitamin D and 600 mg of calcium) for a duration of 24 weeks.
16254993|NCT00973258|Other|Physical Exercise|The exercise intervention group comprises a combination of 2 types of exercise: resistance exercise and in-balance exercise. Key components in both programs are balance and strength, because these are the most prominent domains that should be addressed in at risk frail elderly. The first program is administered in the first 6-week, and then followed by the second program for the next 6-week of intervention period. Both exercise programmes are tailored to the functional needs of the participants, maintaining a moderate intensity that focuses on long-term sustainability and enjoyment.
16254994|NCT00973258|Other|Cognitive Training|"The proposed cognitive training intervention program comprises:
~Reasoning training focusing on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning.
~Memory training focusing on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time.
~Speed training focusing on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors."
16254995|NCT00973258|Other|Combined|Nutritional Intervention + Physical Exercise + Cognitive Training
16254996|NCT00973258|Other|Placebo|Participants will receive their usual diet and placeboes.
16254997|NCT00973245|Drug|Xarelto (Rivaroxaban, BAY59-7939)|10mg od
16254998|NCT00973245|Drug|Xarelto (Rivaroxaban, BAY59-7939)|15mg od
16254999|NCT00973245|Drug|Xarelto (Rivaroxaban, BAY59-7939)|20mg od
16255000|NCT00973245|Drug|Warfarin|Dose-adjusted warfarin based on target INR values
16255001|NCT00973232|Drug|DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)|DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fasting conditions
16255002|NCT00973232|Drug|DDS-06C (650 mg acetaminophen and 75 mg tramadol)|DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fed conditions
16255003|NCT00973232|Drug|Zaldiar®|Zaldiar® (325 mg acetaminophen and 37.5 mg tramadol HCl): two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)
16255004|NCT00973232|Drug|Ultracet®|Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)
16255005|NCT00973232|Drug|Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions|Two tablets of DDS-06C, twice daily at 12-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
16255006|NCT00973232|Drug|Zaldiar®, multiple doses,(fed & fasting):|Two tablets of Zaldiar®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
16255007|NCT00973232|Drug|Ultracet®, multiple doses, (fed & fasting)|Two tablets of Ultracet®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
16255008|NCT00973219|Drug|Peg-Interferon alfa 2a + Adefovir dipivoxil, Peg-Interferon alfa 2a + Tenofovir disoproxil fumarate|Peg-Interferon alfa 2a 180ug/week + Adefovir dipivoxil 10mg/day, Peg-Interferon alfa 2a 180ug/week + Tenofovir disoproxil fumarate 245mg/day
16255009|NCT00973193|Drug|panitumumab|intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days
16255010|NCT00973180|Other|Enhanced Label|A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
16255011|NCT00973167|Device|Low-magnitude high-frequency vibration treatment|Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5 days/week
16255012|NCT00973154|Drug|Prednisone|50mg per day of prednisone orally for 7 days versus placebo
16255013|NCT00973141|Drug|JNJ-42160443|Type=exact number, unit=mg, number=1, form=solution for injection, route=Subcutaneous use. One injection of 1 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
16255014|NCT00973141|Drug|JNJ-42160443|Type=exact number, unit=mg, number=10, form=solution for injection, route=Subcutaneous use. One injection of 10 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
16255015|NCT00973141|Drug|JNJ-42160443|Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
16255016|NCT00973141|Drug|Placebo|Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 4 or 8 weeks for up to 104 weeks.
16255017|NCT00973141|Drug|JNJ-42160443|Type=exact number, unit=mg, number=3, form=solution for injection, route=Subcutaneous use. One injection of 3 mg of JNJ-42160443 every 4 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
16255018|NCT00973141|Drug|JNJ-42160443|Type=exact number, unit=mg, number=6, form=solution for injection, route=Subcutaneous use. One injection of 6 mg of JNJ-42160443 every 8 weeks for up to 104 weeks (JNJ-42160443 at a concentration of 10 mg/mL was provided for use in this study).
16255019|NCT00973128|Drug|GMCSF plus Antimony reduced dose|400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
16255020|NCT00973128|Drug|Meglumine antimoniate|20mg/daily for 20 days
16255021|NCT00973115|Drug|Simvastatin CR|
16255022|NCT00973102|Drug|Premarin IV|One time dose of Premarin IV
16255023|NCT00973102|Drug|Placebo|One time dose of placebo.
16255024|NCT00973089|Other|Incomplete caries removal in primary teeth|Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.
16255025|NCT00973076|Drug|AZD8055|Tablets, orally administered, twice daily
16255026|NCT00973063|Behavioral|Routine sterile gloving|routinely new sterile gloving just before sampling
16255027|NCT00973050|Drug|Bicalutamide|50 mg Tablet
16255028|NCT00973050|Drug|Casodex®|50 mg Tabelt
16255029|NCT00973037|Drug|Tamoxifen|Tamoxifen 20mg qd
16255030|NCT00973024|Drug|JNJ-42160443 3 mg|JNJ-42160443: type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 3 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
16255031|NCT00973024|Drug|JNJ-42160443 1 mg|JNJ-42160443: type=exact number, unit=mg, number= 1, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 1 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
16255032|NCT00973024|Drug|JNJ-42160443 6 mg/3mg|JNJ-42160443: type= exact number, unit= mg, number= 3 and 6, form=solution for injection, route= Subcutaneous use or Placebo: form= solution for injection, route= Subcutaneous injection. 1 inj of 6 mg of JNJ-42160443 on Day 1 followed by 1 inj of 3 mg or matching placebo every 4 wks for up to 104 wks.
16255033|NCT00973024|Drug|JNJ-42160443 10 mg|JNJ-42160443 10 mg: type=exact number, unit=mg, number= 10, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 10 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.
16255034|NCT00973024|Drug|Matching Placebo|Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
16255035|NCT00973011|Drug|FCFD4514S|Intravitreal escalating dose
16255036|NCT00972998|Drug|Phenyephrine|Phenyephrine coated suppositories
16255037|NCT00972985|Drug|modafinil|oral tablet, 100 mg, single acute dose
16255038|NCT00972985|Drug|methylphenidate|oral tablet, 20 mg, single acute dose
16255039|NCT00972985|Drug|lorazepam|oral tablet, 1 mg, single, acute dose
16255040|NCT00972985|Drug|placebo|oral tablet, single acute dose
16255041|NCT00972972|Dietary Supplement|bilberry (European blueberries) and red grape juice|Intervention juice: 50/50 combination of 300 ml bilberry (European blueberries) and red grape juice (Merlot grapes; Vitis Vinifera L.) per day for 9 weeks
16255042|NCT00972972|Dietary Supplement|placebo juice|Placebo juice: 300 ml, similar to the intervention juice as to taste, energy, salt, and carbohydrates
16255043|NCT00972959|Drug|Bortezomib|1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles
16255044|NCT00972959|Drug|Zoledronic Acid|4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months
16255045|NCT00972959|Drug|Dexamethasone|12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles
16255046|NCT00972946|Biological|Administration of autologous Endorem-labelled mononuclear cells intravenously|single dose
16255047|NCT00972946|Drug|Administration of Endorem|single dose, intravenous
16255048|NCT00972933|Drug|ipilimumab|Excisional Biopsy - baseline Induction ipilimumab 10 mg/kg IV day 0, 21 - baseline and week 3 Complete lymph node dissection - week ≥ 6 Maintenance Ipilimumab 10 mg/kg IV - Days 63 (+28 days) and, 84 (+28 days) - (3 weeks apart, starting 2-4 weeks following definitive lymphadenectomy)
16255049|NCT00972920|Procedure|Transversus abdominis plane (TAP) block|Application of local anaesthetic solution (LA) levo-bupivacaine (dose 1mg/kg for each side, concentration 2.5 mg/mL) between internal oblique abdominis muscle and transversus abdominis muscle on both sides.
16255050|NCT00972907|Drug|Nifedipine coated suppositories|12 mg Nifedipine coated suppositories BID
16255051|NCT00972881|Biological|cetuximab|
16255052|NCT00972881|Drug|capecitabine|
16255053|NCT00972881|Drug|irinotecan hydrochloride|
16255054|NCT00972881|Procedure|neoadjuvant therapy|
16255055|NCT00972881|Procedure|therapeutic conventional surgery|
16255056|NCT00972881|Radiation|radiation therapy|
16255057|NCT00972868|Device|A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)|The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period.
16255058|NCT00972855|Drug|Bicalutamide|50 mg Tablet
16255059|NCT00972855|Drug|Casodex®|50 mg Tablet
16255060|NCT00972842|Drug|Vorinostat, Lenalidomide|"Lenalidomide: Dose escalation 10 /15 /20 /25mg/d d1-21 q28d; for 6 treatment cycles
~Vorinostat: 400 mg d1-21 q28d, for 6 treatment cycles"
16255061|NCT00972829|Drug|Rosuvastatin|Rosuvastatin 10 or 20 milligrams once or twice a week
16255062|NCT00972829|Drug|Ezetimibe|Ezetimibe 5 or 10 milligrams
16255063|NCT00972816|Biological|MF59-eH1N1|MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
16255064|NCT00972803|Drug|pistacia Mutica extract|The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
16255065|NCT00972803|Drug|Placebo|The subjects were asked to use a placebo mouthwash twice a day for 4 days.
16255066|NCT00972803|Drug|Chlorhexidine|The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
16255067|NCT00972790|Procedure|Bilateral Scalp Nerve Blocks|Scalp nerve blocks will be performed bilaterally at the end of the surgery under general anaesthesia and before removal of the head holder. Patients will receive scalp nerve blocks with a total of 20 ml of 0.5% bupivacaine + epinephrine 1:200,000 or 20 ml of saline + epinephrine 1:200,000. Solution volume is as follows: 2ml each bilaterally for supraorbital and supratrochlear nerves; 3 ml for the auriculotemporal nerves; 2 ml for the postauricular branches of the greater auricular nerves and for the greater, lesser, and third occipital nerves 3 ml of solution will be infiltrated along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.
16255068|NCT00972777|Drug|Besifloxacin|Besifloxacin 0.6% administered into the study eye two times a day for three days.
16255069|NCT00972777|Drug|Vehicle (Placebo)|Vehicle administered to the study eye two times a day for three days.
16255070|NCT00972738|Drug|montelukast sodium|Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
16255071|NCT00972738|Drug|Comparator: loratadine|Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
16255072|NCT00972738|Drug|Comparator: Placebo|placebo tablet orally once daily at bedtime for 2 weeks
16255073|NCT00972725|Biological|GSK Biologicals' HIV vaccine (732461)|1 dose intramuscular injection
16255074|NCT00972725|Drug|Chloroquine|One dose of 300 mg
16255075|NCT00972712|Drug|Bortezomib and Tipifarnib|"Dose level -1: Bortezomib (0.7 mg/m²; days 1,4,8,11); Tipifarnib (100 mg po BID)
~Dose level 1: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (100 mg po BID)
~Dose level 2: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (200 mg po BID)
~Dose level 3: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (300 mg po BID)
~Dose level 4: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (400 mg po BID)
~Schema B
~Dose level 1: Bortezomib (1.3 mg/m²; Days 1,4,8,11); Tipifarnib (300 mg po BID)
~Dose level 2: Bortezomib (1.3 mg/m²; Days 1,4,8,11); Tipifarnib (400 mg po BID)"
16255076|NCT00972699|Behavioral|Peer support and mentoring|The intervention will be delivered in 4 non consecutive visits during pregnancy and 4 visits post-partum. The sessions will be delivered to mothers living with HIV on the days of their health care appointments either individually or in groups that can accommodate up to 30 mothers living with HIV. The intervention will focus on enhancing the mother-baby relationship through increasing the health of the mother and baby, maintaining the mother's mental health, and reducing HIV transmission.
16255077|NCT00972686|Drug|GSK2126458|GSK2126458 is an experimental treatment for patients with cancer.
16255078|NCT00972673|Drug|Placebo|comparator
16255079|NCT00972673|Drug|GW685698X|Inhaled steroid
16255080|NCT00972660|Biological|Mesenchymal stem cell (MSC)|"Experimental:Mesenchymal stem cell(MSC). Patients with newly diagnosed extensive cGVHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
~Refractory extensive cGVHD: receive primary treatment (prednisone + cyclosporine or tacrolimus, or plus mycophenolate mofetil, or plus methotrexate ) and MSC2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally)."
16255081|NCT00972660|Drug|Prednisone and cyclosporine or primary therapies|"Patients with newly diagnosed extensive cGVHD: prednisone 1mg/kg + cyclosporine or tacrolimus
~Patients with refractory extensive cGVHD: primary treatment (eg.prednisone 1mg/kg + cyclosporine or tacrolimus,or plus mycophenolate mofetil, or methotrexate.)"
16255082|NCT00972647|Procedure|Laser beam guidance|Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging
16255083|NCT00972634|Other|computer-assisted intervention|symptom assessment
16255084|NCT00972634|Other|questionnaire administration|Symptom assessment
16255085|NCT00972634|Procedure|assessment of therapy complications|Symptom assessment
16255086|NCT00972634|Procedure|quality-of-life assessment|Symptom assessment
16255087|NCT00972621|Device|Vitrax II|Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
16255088|NCT00972621|Device|Viscoat|Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..
16255089|NCT00972608|Other|Anatomic Reconstruction and Surgical Planning|Standard of care patient-images will be acquired and used to construct a model of the patient anatomy. The model will then be used to simulate surgical options and allow the surgeon to visually evaluate the optimal approach.
16255090|NCT00972595|Drug|ondansetron clinical trial formulation|Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
16255091|NCT00972595|Drug|ondansetron marketed formulation|Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
16255092|NCT00972582|Dietary Supplement|Leucine Increase|Graded stepwise increases in leucine intakes (50, 250, 500, 750, 1000, 1250 and 1500mg/kg/day)
16255093|NCT00972569|Drug|BNP and PDE-V|low dose BNP 0.025 u/kg/min for 3 hours then 0.005ug/kg/min 45 hours PDE-V 12.5 mg 4 time points
16255094|NCT00972569|Drug|BNP|low dose BNP at 0.025 u/kg/min if tolerated then at 0.005 ug/kg/min for 45 hours
16255095|NCT00972556|Drug|Gray Mineral Trioxide Aggregate (GMTA)|Once hemorrhage from the pulp chamber is under control using direct pressure of a sterile cotton pellet, pulp stumps are covered with a MTA paste, obtained by mixing 0.2g GMTA powder with sterile water in a powder to liquid ratio of 3:1 in weight. The GMTA will be then immediately covered with a zinc-oxide eugenol base (IRM) material.
16255096|NCT00972556|Drug|Diluted (20%) Formocresol (DFC)|After the pulp hemostasis is achieved with direct pressure of a sterile cotton pellet, a sterile cotton pellet dampened with 20% DFC will be placed in contact with the pulp for 5 minutes, followed by the immediate placement of a zinc-oxide eugenol base (IRM) material.
16255097|NCT00972543|Biological|Efalizumab (Raptiva)|"Double-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks.
~Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks."
16255098|NCT00972543|Biological|Placebo|Double-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.
16255099|NCT00972530|Behavioral|immobilisation in a triangular sling|"Intervention group: Immobilisation 48 hours in a triangular sling (mitella)
~Control group: normal activity without restrictions"
16255100|NCT00972517|Biological|GSK investigational vaccine GSK2340272A|Three intramuscular injections
16255101|NCT00972504|Drug|GSK835726 10mg|GSK835726 10mg tablet
16255102|NCT00972504|Drug|GSK1004723 1000mcg|GSK1004723 1000mcg nasal spray solution
16255103|NCT00972504|Drug|Cetirizine 10mg|Cetirizine 10mg active comparator
16255104|NCT00972504|Drug|placebo|placebo to match actives
16255105|NCT00972491|Procedure|Insertion of Laryngeal Mask Airway|The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia
16255113|NCT00972465|Drug|Nimotuzumab and chemotherapy|"Experimental: Nimotuzumab and Irinotecan
~the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression)
~the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)"
16255114|NCT00972452|Behavioral|Exercise|short period of exercise training (5-10 days)
16255115|NCT00972439|Drug|Oral Contraceptive: Ortho-Novum® 1/35|
16255116|NCT00972439|Drug|Oral Contraceptive: Ovcon Fe®|
16255117|NCT00972426|Drug|carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)|Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
16255118|NCT00972413|Radiation|Computed Tomography|In Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
16255119|NCT00972413|Radiation|Computed Tomography|In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
16255120|NCT00972413|Radiation|Computed Tomography|In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.
16255121|NCT00972400|Genetic|protein analysis|
16255122|NCT00972400|Other|laboratory biomarker analysis|
16255123|NCT00972400|Other|mass spectrometry|
16255124|NCT00972400|Other|questionnaire administration|
16255125|NCT00972400|Procedure|assessment of therapy complications|
16255126|NCT00972400|Procedure|cognitive assessment|
16255127|NCT00972400|Procedure|quality-of-life assessment|
16255128|NCT00972387|Dietary Supplement|CHO, CHO-P, CHO-CHO, PLA|The CHO supplement will be administered during trial 1. The CHO-P will be administered during trial 2. The CHO-CHO supplement will be administered during trial 3. The PLA supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
16255129|NCT00972387|Dietary Supplement|CHO-P, CHO-CHO, PLA, CHO|The CHO-P supplement will be administered during trial 1. The CHO-CHO will be administered during trial 2. The PLA supplement will be administered during trial 3. The CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
16255130|NCT00972387|Dietary Supplement|CHO-CHO, PLA, CHO, CHO-P|The CHO-CHO supplement will be administered during trial 1. The PLA will be administered during trial 2. The CHO supplement will be administered during trial 3. The CHO-P supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
16255131|NCT00972387|Dietary Supplement|PLA, CHO, CHO-P, CHO-CHO|The PLA supplement will be administered during trial 1. The CHO will be administered during trial 2. The CHO-P supplement will be administered during trial 3. The CHO-CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
16255132|NCT00972374|Drug|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
16255133|NCT00972374|Drug|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
16255134|NCT00972374|Other|Sham (no implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
16255135|NCT00972348|Other|Online access to a personal health record|Patients in the intervention arm have full access to their online personal health record
16255136|NCT00972348|Other|No access to the PHR|Patients will not be given access to their PHR but will complete online surveys.
16255137|NCT00972335|Drug|Everolimus|This drug will be dosed at 10 mg orally DAILY for the duration of the study.
16255138|NCT00972335|Drug|Bevacizumab|This drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study.
16255139|NCT00972322|Drug|MK-8245|MK-8245 50 mg twice daily for 28 days
16255140|NCT00972322|Drug|Comparator: placebo|matching placebo to MK-8245 twice daily for 28 days
16255143|NCT00972296|Device|Carbon fiber ankle foot orthosis versus cast boot|Relief of ankle pain and normalizing of gait using either device.
16255144|NCT00972283|Drug|insulin degludec|Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.
16255145|NCT00972283|Drug|insulin glargine|Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.
16255146|NCT00972283|Drug|insulin aspart|Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.
16255147|NCT00972270|Device|Impella LP 2.5|Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min.
16255148|NCT00972270|Device|Intra-Aortic Balloon Pump|The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
16255149|NCT00972257|Drug|treatment with dorzolamide/timolol|24-hour IOP control with the two fixed combinations
16255150|NCT00972257|Drug|treatment with brimonidine/timolol|24-hour pressure control with brimonidine/timolol
16255151|NCT00972244|Drug|Dapagliflozin|once daily, 12 weeks
16255152|NCT00972244|Drug|Placebo|once daily, 12 weeks
16255153|NCT00972231|Other|Medical Chart Summary|Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
16255154|NCT00972218|Biological|Adalimumab|Adalimumab subcutaneous injections 40 mg dose every other week for 24 weeks
16255155|NCT00972205|Drug|paclitaxel|Paclitaxel 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days.
16255156|NCT00972205|Drug|CBT-1(Registered Trademark)|CBT-1 500 mg/m^2 oral dose daily for 7 days in divided doses 3 times a day. Cycle days 1-7, repeated every 21 days. no antacids, H2 blocker, or gastric acid inhibiting agents will be administered within 4 hours before or after each daily dose.
16255157|NCT00972205|Radiation|Tc 99m sestamibi|20 mCI baseline scan day 0; 20 mCI scan on 6th day of CBT-1 administered.
16255158|NCT00972192|Behavioral|Inpatient HIV testing|Participants who were randomized to the intervention group received free HIV testing and their results before they were discharged from the hospital.
16255159|NCT00972192|Behavioral|Outpatient HIV testing|Participants randomised to the control arm received referral for testing post-discharge
16255160|NCT00972179|Drug|AMG 157 Placebo|A total of 12 subjects will be receiving multiple doses of AMG 157 placebo. Each subject enrolled in cohorts 1-3 will receive three SC doses; each subject enrolled in cohort 4 will receive six SC doses; each subject enrolled in cohort 5 will receive 12 SC doses; and each subject enrolled in cohort 6 will receive three IV doses throughout the study period of 169 days.
16255161|NCT00972179|Drug|AMG 157|A total of 36 subjects will be receiving multiple doses of AMG 157 (dose escalating by cohort). Each subject enrolled in cohorts 1-3 will receive three SC doses; each subject enrolled in cohort 4 will receive six SC doses; each subject enrolled in cohort 5 will receive 12 SC doses; and each subject enrolled in cohort 6 will receive three IV doses throughout the study period of 169 days.
16255162|NCT00972153|Device|Air Barrier System Device|Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.
16255163|NCT00972153|Device|Sham Air Barrier System device|Device is deployed to the surgery site, but the airflow is not activated. This intervention is used to determine any effects that the presence of the device alone may have.
16255164|NCT00972140|Drug|Formoterol|Formoterol-HFA pMDI 12µg twice daily
16255165|NCT00972140|Drug|Formoterol|Formoterol-DPI 12 µg twice daily
16255166|NCT00972127|Drug|Neramexane|25 mg or 2x25mg tablets
16255167|NCT00972114|Procedure|CABG combined cardiomyoplasty|coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
16255168|NCT00972114|Procedure|CABG combined pedicled omentum graft|Coronary artery bypass graft surgery combined pedicled omentum graft
16255169|NCT00972114|Procedure|CABG alone|Coronary artery bypass graft surgery alone
16255170|NCT00972101|Radiation|Total Body Irradiation (TBI)|3 Gy of radiation on Days -7,-6, -5 and -4.
16255171|NCT00972101|Drug|Melphalan|140 mg/m^2 by vein over 30 minutes as a single dose on Day -8
16255172|NCT00972101|Drug|Thiotepa|10 mg/kg by vein over 4 hours as a single dose on Day -7
16255173|NCT00972101|Drug|Fludarabine|40 mg/m^2 by vein over about 30 minutes 1 time each day on Days -6 through -3.
16255174|NCT00972101|Drug|Rituximab|"Regimen 1:
~375 mg/m^2 may be given by vein over 4 - 6 hours on Day -9 if needed
~Regimen 2:
~375 mg/m^2 may be given by vein over 4 - 6 hours on Day -8 if needed"
16255175|NCT00972101|Drug|Etoposide|60 mg/m^2 by vein over 1-2 hours as a single dose on Day -3.
16255176|NCT00972101|Drug|Anti-thymocyte globulin (ATG)|"Regimen 1:
~1.25 and 1.75 mg/kg by vein over 4-6 hours on the Days -4 and -3.
~Regimen 2:
~0.5, 1.0 and 1.5 mg/kg by vein over 4-6 hours on respective Days -3, -2, and -1."
16255177|NCT00972101|Drug|Mycophenolate Mofetil (MMF)|15 mg/kg pills twice a day starting on day -3, and continued until Day 100+ after transplant (1 gram may be given by vein if necessary).
16255178|NCT00972101|Drug|Tacrolimus|0.03 mg/kg by vein Day -2 as 24 hour continuous infusion for several weeks. After stem cell transplant, tacrolimus given by mouth 2 times a day for up to 6 months.
16255179|NCT00972101|Procedure|Cord Blood Infusion|Cord blood infusion of larger portion through vein using Central Venous Catheter (CVC) on Day 0.
16255180|NCT00972101|Drug|G-CSF|5 mcg/kg day subcutaneously (may round up to the next vial) beginning on day +1 and continuing till absolute neutrophil count is > 2.5 x 10e^9/L.
16255181|NCT00972101|Procedure|Ex vivo expanded T cell Infusion|Infusion by vein of treated cord blood beginning dose of 1 x 10e^5 T cells/kg on Day 14+.
16255182|NCT00972088|Device|capsule endoscopy|The disposable, ingestible PillCam® SB2 Capsule acquires the video images during natural propulsion through the digestive system. The Capsule transmits the acquired images via digital radio frequency communication channel to the Given® Data Recorder unit located outside the body.
16255183|NCT00972075|Drug|melatonin (Circadin)|2 mg prolonged release melatonin tablets once daily 2 hours before going to bed
16255184|NCT00972075|Drug|placebo|one tablet per day 2 hours before going to bed
16255185|NCT00972062|Other|Bach's Rescue Remedy Cream|0.5 ml of cream applied to skin site reactions as needed
16255186|NCT00972062|Other|Placebo Cream|Placebo cream 0.5 ml two times a day as needed
16255187|NCT00972049|Drug|AZD2516|Capsule administered once orally. Specific dose depends on dose panel.
16255188|NCT00972049|Drug|Placebo|Capsule administered once orally
16255189|NCT00972036|Device|SIR-spheres® (Selective Internal Radiation Therapy)|SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.
16255190|NCT00972023|Drug|DHEA|DHEA administration will begin approxiately 14 days prior to surgery.
16255191|NCT00972023|Procedure|Surgical resection|Surgical procedure of the invasive breast cancer
16255192|NCT00971997|Drug|Lispro Mix 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.
16255193|NCT00971984|Other|Medical records summary|Summary of Medical files and laboratory results.
16255194|NCT00971971|Procedure|Dialysis|dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling
16255195|NCT00971971|Procedure|Standard SLED|
16255196|NCT00971958|Procedure|Circumcision|Neonatal circumcision using one of three non-experimental, widely available devices.
16255197|NCT00971958|Device|Mogen Clamp|Mogen clamp is a reusable, one-size stainless steel clamp use for neonatal circumcision.
16255198|NCT00971958|Device|Plastibell|The plastibell is a one-time use device for the circumcision of male neonates, infants and children.
16255407|NCT00970450|Drug|Paracetamol|Paracetamol 1 g i.v. once
16255199|NCT00971958|Device|AccuCirc|AccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life.
16255200|NCT00971945|Drug|Paclitaxel|Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
16255201|NCT00971932|Drug|Cetuximab|The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.
16255202|NCT00971932|Drug|Cisplatin/Carboplatin|Subjects will receive 100 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
16255203|NCT00971932|Drug|5-Fluorouracil|Subjects will receive 1000 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.
16255204|NCT00971919|Other|questionnaire administration|
16255205|NCT00971919|Procedure|assessment of therapy complications|
16255206|NCT00971919|Procedure|psychosocial assessment and care|
16255207|NCT00971919|Procedure|quality-of-life assessment|
16255208|NCT00971906|Biological|Monovalent A/H1N1 influenza vaccine|This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant,or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups
16255209|NCT00971893|Drug|Oral Methylprednisolone Tablets|Oral Methylprednisolone tablets given as per locally approved prescribing information
16255210|NCT00971880|Other|Clinical medical record summary|Summary of immediate and late adverse effects of blood transfusions
16255211|NCT00971867|Drug|Paclitaxel|Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
16255212|NCT00971854|Procedure|Alteration of deep brain stimulator settings|From 130Hz to 60Hz pallidal stimulation
16255213|NCT00971841|Drug|Paclitaxel|
16255214|NCT00971815|Drug|Escitalopram|first week: 10mg/day. Then, treatment with 20mg/day is continued throughout a 3 months period of time.
16255215|NCT00971815|Drug|placebo|1/2 pill pr day first week, then 1 pill pr. day throughout a 3 months treatment period (90-118 ± 7days)
16255216|NCT00971802|Drug|PF-03882845 or Placebo|PF-03882845 20 mg or Placebo, daily for 10 days.
16255217|NCT00971802|Drug|PF-03882845 or Placebo|PF-03882845 60 mg or Placebo, daily for 10 days.
16255218|NCT00971802|Drug|PF-03882845 or Placebo|PF-03882845 120 mg or Placebo, daily for 10 days.
16255219|NCT00971802|Drug|PF-03882845 or Placebo|PF-03882845 185 mg or Placebo, daily for 10 days.
16255220|NCT00971789|Radiation|fludeoxyglucose F 18|Fludeoxyglucose is the radioactive material/compound used as an injection to have a PET scan performed.
16255221|NCT00971789|Drug|sirolimus|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects
16255222|NCT00971789|Other|Clinical Videography|This examination involves testing of cerebellar function that controls movement, balance, and coordination.
16255223|NCT00971776|Device|AB Portable Driver System|Evaluate the safety and performance of the AB Portable Driver System in home environment.
16255224|NCT00971763|Biological|rituximab|
16255225|NCT00971763|Drug|cyclophosphamide|
16255226|NCT00971763|Drug|gemcitabine hydrochloride|
16255227|NCT00971763|Drug|prednisolone|
16255228|NCT00971763|Drug|vincristine sulfate|
16255229|NCT00971737|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|Given intradermally
16255230|NCT00971737|Biological|trastuzumab|Given IV
16255231|NCT00971737|Drug|cyclophosphamide|Given IV
16255232|NCT00971724|Drug|Placebo|Oral administration, once daily, for 15 days
16255233|NCT00971724|Drug|Prednisolone|Oral administration
16255234|NCT00971711|Biological|Probiotic|The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.
16255235|NCT00971685|Drug|Lenalidomide and dexamethasone|RD regimen: Lenalidomide 25 mg/die for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg).
16255236|NCT00971672|Other|Questionnaire filling and laboratory analysis|"A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.
~The laboratory analysis will include complete blood count and serum ferritin analysis."
16255237|NCT00971659|Drug|insulin glargine + exenatide + preexisting metformin|insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin
16255238|NCT00971659|Drug|insulin glargine + sitagliptin + preexisting metformin|insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin
16255239|NCT00971659|Drug|insulin glargine + preexisting metformin|insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
16255240|NCT00971646|Other|Micturition diary|On the micturition diary patients are asked to note every void and drink. With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
16255241|NCT00971646|Other|Hospital Anxiety and Depression scale|This questionnaire is designed to screen for the presence of a mood disorder.
16255242|NCT00971646|Other|EuroQol-5D|This questionnaire grades the health condition of the subject.
16255243|NCT00971646|Other|Self-consciousness questionnaire|The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
16255244|NCT00971633|Drug|Comparator: Treatment A (Zofran, ondansetron)|an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
16255245|NCT00971633|Drug|Comparator: Treatment B (Zofran, ondansetron)|a single 8 mg tablet of Zofran marketed in the U.K., taken PO
16255246|NCT00971633|Drug|Comparator: Treatment C (Zofran, ondansetron)|a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
16255247|NCT00971620|Biological|Botulinum toxin type A|Given as an intralesional injection.
16255248|NCT00971620|Other|Placebo|Given as an intralesional injection
16255249|NCT00971607|Drug|Oxygen + Sevoflurane|Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
16255250|NCT00971607|Drug|Oxygen (placebo)|Control will receive oxygen only.
16255251|NCT00971594|Behavioral|Dietary counseling|1 hour sessions, once per week, with a registered dietitian on the American Heart Association Step I diet with caloric intake for each volunteer adjusted by the dietitian to elicit a WL of ~0.2-0.4 kg/wk
16255252|NCT00971594|Behavioral|AEX|Moderate aerobic exercise (75-80% HRR for 45 min) at the Baltimore GRECC exercise facility using treadmills 3 times per week for 6 months.
16255253|NCT00971581|Drug|FDC KETOPROFEN+OMEPRAZOLE|Ketoprofen + Omeprazole FDC once daily for 4 weeks
16255254|NCT00971542|Biological|Monovalent A/H1N1 influenza vaccine|This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
16255255|NCT00971516|Procedure|Implant placement|dental implant placement
16255256|NCT00971516|Procedure|Implants surgery|dental implant surgery
16255257|NCT00971503|Procedure|autologous bone marrow implantation|Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery
16255258|NCT00971503|Other|Saline injection|Injection of saline solution for 5 days
16255259|NCT00971490|Device|Acu-TENS (Transcutaneous electrical nerve stimulation)|Transcutaneous electrical nerve stimulation applied onto acupuncture point
16255260|NCT00971490|Device|Acu-TENS (Transcutaneous electrical nerve stimulation)|Similar to Group 1 but without electrical stimulation
16255261|NCT00971490|Device|Acu-TENS (Transcutaneous electrical nerve stimulation)|Similar to Group 1 but applied onto non acupuncture point
16255262|NCT00971477|Other|Online Teledermatology Care|Patients randomized to the intervention group will have their scheduled follow-up visits online via a store and forward teledermatology modality.
16255263|NCT00971477|Other|Conventional in Office Care|Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
16255264|NCT00971464|Behavioral|eccentric viewing (EV) training|Eccentric viewing training for 6 weeks, minimum two 10 minutes per day.
16255265|NCT00971464|Device|Closed circuit television (CCTV)|A CCTV is an electro-optical device mainly used for reading.
16255266|NCT00971451|Other|cryotherapy|20 minutes of knee joint cryotherapy - ice bag application
16255267|NCT00971451|Other|TENS|continuous use of TENS during the exercise session
16255268|NCT00971438|Procedure|Diagnostic imaging|Patients with a scoring suggesting an equivocal diagnosis of appendicitis are randomised to diagnostic imaging (CT or US) or repeat examination after inhospital observation
16255269|NCT00971425|Biological|Pandemrix (GSK investigational influenza GSK2340272A vaccine)|2 doses intramuscular injections
16255270|NCT00971425|Biological|Fluarix™|1 dose intramuscular injection
16255271|NCT00971425|Biological|Placebo|1 dose intramuscular injection
16255272|NCT00971399|Drug|ramosetron|ramosetron 0.1mg q.d. SL on D1-5
16255273|NCT00971399|Drug|ondansetron|ondansetron 8mg, b.i.d SL on D1-5
16255274|NCT00971386|Behavioral|Slow breathing|The subjects will be given instructions in slow breathing at a rate of 6 to 10 breaths per minute and asked to practice it for some time. Hemodynamic measurements would be repeated before, during and after the trial of slow breathing. A Noninvasive Cardiac Output Monitor will be used. It uses a technology called impedance to measure cardiac output and other hemodynamic parameters by the passage of electric currents through the thorax. This device uses four electrode stickers applied to the thorax and the neck.
16255275|NCT00971373|Other|Vestagen scrubs|antimicrobial impregnated textile
16255276|NCT00971360|Other|conversion disorder|Proinflammatory cytokine levels in conversion disorder
16255277|NCT00971347|Other|Extra sugar-free chewing gum sticks|90 minutes chewing per day after meals; mid-morning and mid-afternoon; 1 to 2 hours after dinner; and in response to hunger, cravings, preoccupation with eating, or negative feelings in general throughout the day.
16255278|NCT00971347|Behavioral|nutrition brochure|one-time at baseline visit
16255279|NCT00971321|Biological|Pandemic influenza vaccine GSK2340272A|Two primary intramuscular (IM) injections
16255280|NCT00971308|Drug|BMS-824393|Capsule, Oral, 50mg, Once Daily, 3 days
16255281|NCT00971308|Drug|BMS-824393|Capsule, Oral, 100mg, Once Daily, 3 days
16255282|NCT00971308|Drug|BMS-824393|Capsule, Oral, 10mg, Once Daily, 3 days
16255283|NCT00971308|Drug|BMS-824393|Capsule. Oral, 1mg, Once Daily, 3 days
16255284|NCT00971308|Drug|BMS-824393|Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
16255285|NCT00971295|Drug|Metformin|850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
16255286|NCT00971295|Drug|Eslicarbazepine acetate|
16255287|NCT00971282|Drug|adapalen 0.1%|"Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks.
~Visits will be conducted weekly for a maximum of 5 visits."
16255288|NCT00971282|Other|Cetaphil®|"Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks.
~Visits will be conducted weekly for a maximum of 5 visits."
16255289|NCT00971269|Device|Solesta (Nasha/Dx)|Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
16255290|NCT00971243|Drug|MP-513 Lowest Dose and Metformin|MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
16255291|NCT00971243|Drug|MP-513 Low Dose and Metformin|MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
16255292|NCT00971243|Drug|MP-513 Medium Dose and Metformin|MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
16255293|NCT00971243|Drug|MP-513 High Dose and Metformin|MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
16255408|NCT00970450|Drug|Tropisetron|Tropisetron 5 mg i.v. once
16255294|NCT00971243|Drug|Placebo and Metformin|Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
16255295|NCT00971230|Drug|FTC/TDF|emtricitabine/tenofovir disoproxil fumarate
16255296|NCT00971230|Drug|Placebo|Placebo
16255297|NCT00971217|Other|Exercise|Moderate intensity aerobic exercise on the bike/cross trainer/ rower/ treadmill and resistance exercise on the weights machines, twice per week for 10 weeks.
16255298|NCT00971217|Behavioral|Online Cognitive Behavioural Therapy|Participants will be asked to log-on to a website aimed at young men once per week. Participants will be asked to read a vignette or watch a specific video clip, which will be updated each week by the researcher. Participants will be asked to respond to the vignette/video clip on the website. This should take no longer than 10-15 minutes to complete. Different themes (such as those addressed by traditional cognitive behavioural therapy) will be introduced each week. Themes include: relaxation, identifying positive strengths, body image, goal-setting, problem-solving, resilience, self-care behaviour and sources of support.
16255299|NCT00971204|Device|CardioFocus HeartLight Endoscopic Ablation System|PVI ablation
16255300|NCT00971191|Drug|PF-00299804|Brief exposure (5- 11 days) to study drug prior to surgical resection
16255301|NCT00971178|Drug|local dexmedetomidine|Preoperative normal saline infusion and 1mcg/kg dexmedetomidine infiltrated locally to wound at the end of operation.
16255302|NCT00971178|Drug|Peripheral normal saline|Same volume of normal saline as dexmedetomidine is infiltrated and IV infusion.
16255303|NCT00971178|Drug|IV dexmedetomidine|IV dexmedetomidine 1mcg/kg peroperative and normal saline infiltrated to wound at the end of operation
16255304|NCT00971165|Drug|losartan|Oral losartan up to 100 mg daily fo 18 months
16255305|NCT00971165|Drug|Chlorthalidone plus amiloride|Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily, once a day for 18 months
16255306|NCT00971152|Drug|menotropins for injection|comparison of different dosages
16255307|NCT00971152|Drug|urofollitropin for injection|comparison of different dosages
16255308|NCT00971139|Behavioral|Access to an OPPC service|Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors
16255309|NCT00971126|Drug|sorafenib (Nexavar®), thalidomide (Thado®)|"Phase I Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and Escalation dose of Thalidomide at dose Level I: 50 mg/day (50mg, p.o., qd); Level II: 100 mg/day (50mg, p.o., bid); Level III: 150 mg/day (100mg/50mg, p.o., bid); Level IV: 200 mg/day (100mg, p.o., bid).
~Phase II Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and MTD of Thalidomide at phase I study."
16255310|NCT00971113|Dietary Supplement|sc-FOS and Sideritis euboea extract|"dietary supplement: jelly with 5g sc-FOS and 0.3g Sideritis euboea extract per daily portion for 30 days
~placebo food: jelly with no sc-FOS and Sideritis euboea"
16255311|NCT00971100|Biological|Monovalent A/H1N1 influenza vaccine|This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
16255312|NCT00971087|Device|Hologic Selenia Dimensions Digital Breast Tomosynthesis System|Subjects are enrolled from either a screening population or a biopsy population. Both groups are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects recruited in the biopsy population will be imaged on the investigational device prior to their biopsy procedure.
16255313|NCT00971074|Drug|Hylan G-F 20|6 ml intra-articular injection given once. The injection takes approximately 15 seconds.
16255314|NCT00971074|Other|Sham Injection|A needle will be inserted through the knee capsule but no medication will be injected.
16255315|NCT00971061|Device|Ahmed valve implant|184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
16255316|NCT00971061|Device|Molteno single-plate implant (MSPI)|134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
16255317|NCT00971048|Device|HP828-101|Topical test article applied once daily
16255318|NCT00971048|Device|Hydrogel/Hydrocolloid|Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily
16255319|NCT00971035|Drug|lebrikizumab (MILR1444A)|Subcutaneous repeating dose
16255320|NCT00971035|Drug|lebrikizumab (MILR1444A)|Subcutaneous repeating dose
16255321|NCT00971035|Drug|lebrikizumab (MILR1444A)|Subcutaneous repeating dose
16255322|NCT00971035|Drug|placebo|Subcutaneous repeating dose
16255323|NCT00971022|Behavioral|Survey|20 minute survey to determine the relationship between awareness of the discount generic prescription program and utilization of the program.
16255324|NCT00971022|Behavioral|Focus Group|5 - 8 focus groups of 6 - 10 people, lasting approximately 90 minutes
16255325|NCT00971009|Behavioral|OPPC service|Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
16255326|NCT00971009|Behavioral|WebChoice IHCA|The additional features of WebChoice allows patients to monitor their symptoms and health problems from home; provides them with individually tailored, just-in-time information and support to manage their symptoms and illness-related problems between treatments and during rehabilitation; and a forum, or e-group community, for group discussion with other cancer patients.
16255327|NCT00970996|Drug|Temozolomide|250 mg/m^2 by mouth on days 1, 2, and 3 of each 21-day cycle.
16255328|NCT00970996|Drug|Abraxane|100 mg/m^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m^2 given on day 5 of each 21-day cycle.
16255329|NCT00970996|Drug|Cisplatin|20 mg/m^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.
16255330|NCT00970996|Biological|Interleukin-2|9 MIU/m^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.
16255331|NCT00970996|Biological|Interferon alpha 2b|5 MIU/m^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.
16255409|NCT00970450|Drug|Placebo|Saline
16255332|NCT00970983|Procedure|quadrantectomy and axillary dissection|standard quadrantectomy and axillary dissection
16255333|NCT00970983|Procedure|quadrantectomy + sentinel node biopsy|standard quadrantectomy and selective axillary dissection only if sentinel node biopsy is positive
16255334|NCT00970970|Other|89Zr bevacizumab PET scan|Patients will be injected intravenously with 37 MBq, protein dose 5 mg 89Zr-bevacizumab at day 0. PET scans will be done at day 4.
16255335|NCT00970957|Drug|Avastin Intravitreal Injection|Intravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol
16255336|NCT00970957|Drug|Sham Avastin Intravitreal Injection|Intravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...).
16255337|NCT00970944|Drug|Amantadine Hydrochloride|184 patients who remain in VS or MCS 4 - 16 weeks post-TBI will be randomized in a stratified fashion to 4 weeks of amantadine (200 - 400 mg/day) followed by a 2-week washout period. The Disability Rating Scale (DRS) will be the primary dependent variable with the Coma Recovery Scale-Revised (CRS-R) serving as a supplementary measure.
16255338|NCT00970944|Drug|Placebo|Placebo administered twice daily.
16255339|NCT00970931|Drug|Chlorthalidone plus amiloride|Oral Chlorthalidone 12.5 mg plus amiloride 2.5 mg, once a day for 18 months
16255340|NCT00970931|Drug|placebo|Oral placebo once a day, for 18 months
16255341|NCT00970918|Procedure|Measurement of the Carotid Intima Media thickness|one time, radiological procedure on both sides of the neck
16255342|NCT00970918|Biological|Blood sample testing for hs-CRP|one time, blood sample taking
16255343|NCT00970905|Drug|aprepitant|aprepitant 125 mg po (Mondays), 80 mg po (Wednesdays), 80 mg po (Fridays) with doses scheduled 1-2 hours prior to the day's radiation fraction. Aprepitant will not be administered on weekend days. Aprepitant administration will continue until the last day of radiotherapy.
16255344|NCT00970905|Drug|Ondansetron|Ondansetron 8 mg po bid, with the morning dose scheduled 1-2 hours prior to the day's radiation fraction. Ondansetron will not be administered on weekend days. Ondansetron administration will continue until the last day of radiotherapy.
16255345|NCT00970892|Drug|Warfarin dose titration|Dosage
16255346|NCT00970879|Drug|cotrimoxazole|800 mg sulfamethoxazole and 160 mg trimethoprim daily, from 28 weeks of gestation until delivery
16255347|NCT00970879|Drug|mefloquine|mefloquine 15 mg/Kg three times, between 16 and 28 weeks, 24 and 32 weeks, then 28 and 36 weeks of pregnancy
16255348|NCT00970866|Dietary Supplement|Iron and Folic Acid (IFA)|Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals
16255349|NCT00970866|Dietary Supplement|Multiple Micronutrient (MMN) group|Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals
16255350|NCT00970866|Dietary Supplement|Lipid-based Nutrient Supplements (LNS) group|"Pregnant women will receive 20 g of LNS-P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age.
~The LNS products (LNS-P&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration."
16255351|NCT00970853|Behavioral|MOM Program home visiting|Mixed professional home visiting program.
16255352|NCT00970853|Other|Control|Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
16255353|NCT00970840|Dietary Supplement|LNS-20gM or LNS-P&L|Participants consumed a test meal (45 g or 50 g) consisting of LNS-20gM or LNS-P&L mixed with fermented maize porridge, after which they were provided with the respective LNS supplements for use at home daily for 14 d
16255354|NCT00970827|Procedure|remote ischemic postconditioning|Three 5- minute cycles of blood pressure cuff inflation according to the assigned group. The cuff is inflated to 200 mm Hg (and at least 20 mmHg above the systolic blood pressure) for 5 minutes followed by a 5-minute deflation (reperfusion).
16255355|NCT00970814|Behavioral|BBCET|11 BBCET sessions
16255356|NCT00970814|Behavioral|BBCET|11 BBCET Sessions
16255357|NCT00970814|Drug|Levetiracetam XR|500mg - 2000mg Once per day 16 weeks
16255358|NCT00970814|Drug|Sugar Pill|500mg - 2000mg Once per day 16 weeks
16255359|NCT00970788|Behavioral|Video intervention|Video of goals of care
16255360|NCT00970775|Drug|AZD2423|oral solution, single dose
16255361|NCT00970775|Drug|Placebo|oral solution,single dose
16255362|NCT00970762|Drug|Rocuronium 0.6 mg/kg intubating dose|Rocuronium 0.6 mg/kg intubating dose
16255363|NCT00970762|Drug|Rocuronium 0.9 mg/kg intubating dose|0.9 mg/kg intubating dose of rocuronium
16255364|NCT00970762|Drug|Rocuronium 0.1 mg/kg maintenance dose|Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
16255365|NCT00970762|Drug|Rocuronium 0.15 mg/kg maintenance dose|Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
16255366|NCT00970762|Drug|Rocuronium 0.2 mg/kg maintenance|Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
16255367|NCT00970762|Drug|Vecuronium 0.1 mg/kg intubating dose|Vecuronium 0.1 mg/kg intubating dose
16255368|NCT00970762|Drug|Vecuronium 0.025 mg/kg maintenance dose|Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
16255369|NCT00970723|Behavioral|high blood pressure treatment|over one 14 month period: strongly recommended hygiene-dietetic measurements, complete assessment with ambulatory measurement of the blood pressure in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months
16255568|NCT00968981|Drug|GDC-0449|Three times weekly oral repeating dose
16255370|NCT00970723|Behavioral|sleep apnea treatment|over one 14 month period: complete assessment with night polysomnography in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months
16255371|NCT00970723|Behavioral|diabetic macular edema treatment|over one 14 month period: control every 3 months, treatments by laser (focal or grid) are authorized until 9 months, treatments by injections are authorized until 6 months
16255372|NCT00970710|Behavioral|Vaasa Childhood Obesity Primary Prevention Study|Intensified counselling concerning healthy diet and suitable physical activity during pregnancy to mothers in the intervention group continuing in child health care clinic visits with the offspring until child's age of 5 year.
16255373|NCT00970697|Drug|becaplermin gel|the amount of the gel to be applied was determined based on ulcer area at inclusion and remains identical during all the treatment The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Becaplermin gel is packaged into masked 15g-tubes.
16255374|NCT00970697|Drug|Duoderm Hydrogel™|The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Hydrogel dressing is identical in appearance, color, consistency, and odor than becaplermin gel, and packaged in similar masked15g-tubes.
16255375|NCT00970684|Biological|bevacizumab|15 mg/kg on day 1 of a 21-day cycle
16255376|NCT00970684|Drug|docetaxel|75 mg/m2 on day 1
16255377|NCT00970684|Drug|gemcitabine hydrochloride|900 mg/m2 on days 1, and 8,
16255378|NCT00970671|Other|Laser treatment with Purpuric settings|Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
16255379|NCT00970671|Other|Laser treatment with Nonpurpuric settings|Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
16255380|NCT00970671|Other|No treatment|No laser treatment
16255381|NCT00970658|Drug|Salonsip plaster|The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
16255382|NCT00970658|Drug|Sabia plaster|The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
16255383|NCT00970645|Procedure|Mediastinoscopy/thoracoscopy|Mediastinoscopy used to detect/stage lung cancer.
16255384|NCT00970645|Procedure|EBUS/EUS|Minimal invasive technique to stage/detect lung cancer.
16255385|NCT00970632|Drug|Tadalafil 5 mg|Tadalafil 5 mg po QD for 12 weeks
16255386|NCT00970632|Drug|Placebo tablet|Placebo tablet po QD for 12 weeks
16255387|NCT00970632|Drug|Tamsulosin|Tamsulosin 0.4 mg po QD for 12 weeks
16255388|NCT00970632|Drug|Placebo capsule|Placebo capsule po QD for 12 weeks
16255389|NCT00970619|Device|Ekos endowave system thrombolysis|Catheter directed thrombolysis will be performed with an Ekos Endowave ® system (EKOS Corporation, Bothell, WA). The system uses a standard guide wire to position the Intelligent Drug Delivery Catheter across the length of the target clot. The guide wire is introduced through the popliteal vein. Along the guide wire the catheter is positioned. The location of the dispersion catheter is controlled and if necessary adjusted by X-ray. The guide wire is then pulled out and replaced with the Microsonic core (a miniscule high frequency (2MHz) ultrasound transducer). The system automatically monitors and controls the microsonic energy delivery. This system does not fragment the thrombus but only gives a structural change by which a better penetration of the thrombolytic agent is achieved.
16255390|NCT00970606|Drug|Rosuvastatin (crestor)|20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
16255391|NCT00970606|Drug|Placebo|Placebo tablet identical to active therapy. 1 tablet per day
16255392|NCT00970593|Drug|OAP-189|Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation)
16255393|NCT00970593|Drug|placebo comparator|Group 1 & 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days
16255394|NCT00970580|Drug|BIIB022 With Paclitaxel and Carboplatin|Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin
16255395|NCT00970567|Behavioral|Different insulin therapy at different time points|different insulin therapy after positive blood ketones
16255396|NCT00970554|Other|Patching|Patching of the sound eye for 30 minutes a day for 17 weeks.
16255397|NCT00970554|Other|Telescopic magnification|Patching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks.
16255398|NCT00970541|Dietary Supplement|Cinnamon Supplementation|1, 3, or 6g of cinnamon per day for 40 days
16255399|NCT00970541|Dietary Supplement|Placebo (wheat flour)|1, 3, or 6g of placebo per day for 40 days
16255400|NCT00970528|Drug|Acarbose (Glucobay, BAYG5421)|uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin
16255401|NCT00970528|Drug|Voglibose (Basen)|uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin
16255402|NCT00970515|Procedure|Laparoscopic mesh hernia repair|The mesh is intraperitoneal
16255403|NCT00970515|Procedure|Open anterior approach|The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal
16255404|NCT00970502|Drug|erlotinib + celecoxib|In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
16255405|NCT00970489|Drug|Omega -3 fatty acids|10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
16255410|NCT00970437|Behavioral|Cognitive Behavioral Analysis System of Psychotherapy|Duration of intervention per patient: 20 weeks acute treatment (n=24 sessions) followed by 28 weeks of continuation treatment (n=8 sessions) Follow-up per patient: 48 weeks after randomisation
16255411|NCT00970437|Behavioral|System of Supportive Psychotherapy|Duration of intervention per patient: 20 weeks acute treatment (n=24 sessions) followed by 28 weeks of continuation treatment (n=8 sessions) Follow-up per patient: 48 weeks after randomisation
16255412|NCT00970424|Drug|Placebo|placebo, oral tablet administered once daily on background of pioglitazone
16255413|NCT00970424|Drug|Dutogliptin|dutogliptin, oral tablet administered once daily on background of pioglitazone
16255414|NCT00970411|Drug|KRN951|Orally once daily administration
16255415|NCT00970398|Other|Infant formula supplemented with bovine milk Osteopontin|Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.
16255416|NCT00970398|Other|Standard infant formula|Infant formula without supplementation of bovine milk Osteopontin
16255417|NCT00970385|Drug|CHOP21|"CHOP regimen:
~cyclophosphamide 750 mg/m2 intravenously (IV) day 1
~doxorubicin 50 mg/m2 IV day 1
~vincristine 1,4 mg/m2 (maximum 2 mg) day 1
~prednisone 100 mg/m2/D from D1 to D5."
16255418|NCT00970385|Drug|VIP/ABVD|"VIP regimen:
~etoposide 100 mg/m2/D IV from D1 to D3
~ifosfamide 1000 mg/m2/D from D1 to D5
~cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5
~ABVD regimen:
~doxorubicin50 mg/m2/D on D1 and D14
~bleomycin 10 mg/m2/D
~vinblastine 10 mg/m2/D
~dacarbazine 375 mg/m2/D"
16255419|NCT00970385|Radiation|Radiotherapy consolidation|The treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field.
16255420|NCT00970359|Biological|AZD6244|"Within 1 week of starting the study: Low iodine diet
~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
16255421|NCT00970346|Drug|OligoG CF-5/20|Inhaled OligoG CF-5/20 will be given to healthy volunteers with different concentrations to test tolerability of the drug
16255422|NCT00970333|Drug|[18F]-FEPPA|Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not >10% of 5 mCi limit) of [18F]-FEPPA followed by serial PET imaging
16255423|NCT00970320|Other|Pelvic floor muscle training|6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist.
16255424|NCT00970307|Biological|GSK2202083A vaccine|Intramuscular, three doses
16255425|NCT00970307|Biological|10-valent pneumococcal vaccine (GSK 1024850A)|Intramuscular, three doses
16255426|NCT00970307|Biological|Infanrix hexa™|Intramuscular, three doses
16255427|NCT00970307|Biological|Menjugate®|Intramuscular, two doses
16255428|NCT00970294|Behavioral|Health Promotion Program|10 week health promotion program 3-4 times per week
16255429|NCT00970281|Drug|Rapid-Acting Intramuscular Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections
16255430|NCT00970281|Drug|Placebo|Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections
16255431|NCT00970268|Drug|Aclidinium bromide|Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
16255432|NCT00970268|Drug|Aclidinium bromide|Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
16255433|NCT00970255|Procedure|Lingual Frenulum frenotomy|Clipping the lingual frenulum with scissors
16255434|NCT00970255|Procedure|Sham frenotomy|Sham Clipping the lingual frenulum with scissors
16255435|NCT00970229|Drug|[123I]MNI-420|Subjects will be injected with 8mCi, not to exceed 8.8 mCi (not > 10% of 8 mCi limit)of [123I]MNI-420, followed by SPECT imaging.
16255436|NCT00970216|Drug|Telbivudine|Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment
16255437|NCT00970203|Biological|androgen ablation (AA)|Lupron 22.5 mg or Zoladex 10.8 mg
16255438|NCT00970203|Biological|DC1 vaccine|3-5 x 10e6 cells total
16255439|NCT00970177|Biological|Monovalent A/H1N1 influenza vaccine|This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
16255440|NCT00970138|Drug|apatinib tablet|"A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
~B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
~Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent"
16255441|NCT00970125|Behavioral|video|outline of the goals of care
16255442|NCT00970112|Procedure|Open Flap Debridement|Open flap debridement - access flap + scaling and root planning
16255443|NCT00970099|Behavioral|exercise|Patients exercise under supervision on either a treadmill, Stair Master, or LifeCycle apparatus. Exercise frequency, duration, and intensity will be incrementally increased to minimize the risk of injury. During weeks 1-3, you will exercise for 30 minutes 3 days per week at 70- 80 % of your maximum heart rate (MHR); weeks 4-7 will consist of exercising for 40 minutes 4 days per week at 70-80% of your MHR; and weeks 7-12 will consist of exercising for 45 minutes 4 days per week at 80-85% MHR
16255444|NCT00970099|Behavioral|Non exercise|subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist
16255569|NCT00968981|Drug|GDC-0449|Once weekly oral repeating dose
16255570|NCT00968968|Drug|Lapatinib|Oral Lapatinib 1000 mg once daily. Lapatinib was a small molecule, reversible inhibitor targeting HER2 tyrosine kinase receptor.
16255445|NCT00970086|Drug|Bupivacain/levobupivacaine|"Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.
~Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%."
16255446|NCT00970073|Biological|Thymoglobulin 3mg total|1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
16255447|NCT00970073|Biological|Thymoglobulin 4.5mg total|1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
16255448|NCT00970073|Drug|Mycophenolate mofetil|1000 mg PO/IV BID for up to 6 months
16255449|NCT00970073|Drug|tacrolimus 3-8|Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
16255450|NCT00970073|Drug|tacrolimus 8-12|Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
16255451|NCT00970060|Behavioral|Exercise|Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.
16255452|NCT00970021|Dietary Supplement|Intake of 60 ml placebo daily in addition to chemotherapy|The patients will drink 60 ml of placebo daily from start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment is approximately 7 weeks.
16255453|NCT00970021|Dietary Supplement|Intake of 60 ml agaricus daily in addition to chemotherapy|The patients will drink 60 ml of agaricus extract from the start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment: Approximately 7 weeks
16255454|NCT00970008|Other|Massage 30 min 2x/wk x4 wks then 1x/wk x4 wks|Swedish massage session of 30 minutes duration, twice weekly for four weeks followed by once weekly for four weeks over a eight (8) week period. Total intervention = 12 sessions for 360 minutes.
16255455|NCT00970008|Other|Massage 60 min 2x/wk for 4 wks then 1x/wk for 4 wks|Swedish massage session of 60 minutes duration, twice weekly for four weeks followed by once weekly for four weeks over a eight (8) week period. Total intervention = 12 sessions for 720 minutes.
16255456|NCT00970008|Other|Massage 30 min sessions 1x/wk for 8 wks|Swedish massage session of 30 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 240 minutes.
16255457|NCT00970008|Other|Massage 60 min session 1x/wk for 8 wks|Swedish massage session of 60 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 480 minutes
16255458|NCT00969982|Drug|mifepristone+misoprostol|single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
16255459|NCT00969982|Drug|misoprostol+placebo|placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
16255460|NCT00969969|Device|Arthrodesis|arthrodesis using screws and/or a plate
16255461|NCT00969969|Device|Cartiva|Cartiva Synthetic Cartilage Implant
16255462|NCT00969917|Drug|IPI-504|IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
16255463|NCT00969904|Drug|N-acetylcysteine|600 mg TID for 12 weeks
16255464|NCT00969904|Drug|placebo|placebo tablet TID for 12 weeks
16255465|NCT00969891|Other|PK-PD analysis|The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.
16255466|NCT00969878|Drug|TA-CD Vaccination|On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.
16255467|NCT00969878|Other|Placebo Injection|On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.
16255468|NCT00969852|Drug|Sertraline|Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
16255469|NCT00969839|Device|NovaLign Intramedullary Fixation System|Intramedullary fixation of broken humerus
16255470|NCT00969826|Drug|GCPGC, Neulasta, Placebo|A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
16255471|NCT00969813|Drug|CP-690,550|Single 10 mg dose of CP-690,550
16255472|NCT00969813|Drug|CP-690,550|Single 10 mg dose of CP-690,550
16255473|NCT00969813|Drug|CP-690,550|Single 10 mg dose of CP-690,550
16255474|NCT00969800|Device|Cleverin Gel|Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
16255475|NCT00969800|Device|Inactive Cleverin Gel|Seemingly same chlorine dioxide gas-generating device, but no gas is generated.
16255476|NCT00969787|Drug|DWP05195|tablets, oral administration, single and multiple administrations
16255477|NCT00969761|Drug|BI-6727|Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added
16255478|NCT00969761|Drug|BI 6727|low to high dose
16255479|NCT00969735|Device|Pulmonary vein cryoablation|A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.
16255571|NCT00968968|Biological|Trastuzumab|IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab was a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.
16255480|NCT00969735|Device|Pulmonary vein radiofrequency ablation|Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter > 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.
16255481|NCT00969722|Biological|MAb-3F8|
16255482|NCT00969722|Biological|Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)|
16255483|NCT00969722|Biological|13-cis-Retinoic Acid|
16255484|NCT00969709|Drug|Levomilnacipran ER|Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
16255485|NCT00969709|Drug|Levomilnacipran ER|Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
16255486|NCT00969709|Drug|Levomilnacipran ER|Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
16255487|NCT00969709|Drug|Placebo|Matching placebo capsules, oral administration, once daily for 8 weeks.
16255488|NCT00969696|Drug|Placebo|8Mg a day of a sugar pill
16255489|NCT00969696|Drug|Galantamine|8mg of Galantamine
16255490|NCT00969683|Device|Tracheal intubation|Tracheal intubation using a Double lumen tube without a hook
16255491|NCT00969683|Device|Tracheal intubation|Tracheal intubation with a Double lumen tube with a hook
16255492|NCT00969644|Drug|Somatropin|s.c injections once daily 10-30 mícrogram/kg/day
16255493|NCT00969644|Drug|Pegvisomant|s.c. injections once daily (10-15 mg/day)
16255494|NCT00969631|Drug|metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)|metformin HCl 1500 daily for 6-8 weeks then 100 mg CC for 5 days starting from day 3 of menstruation up to 6 cycles.
16255495|NCT00969631|Procedure|Laparoscopic ovarian diathermy (LOD)|Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
16255496|NCT00969618|Drug|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
16255497|NCT00969605|Procedure|Comparison of two different modes for weaning from mechanical ventilation|Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.
16255498|NCT00969592|Drug|insulin glulisine, insulin aspart|single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp
16255499|NCT00969592|Drug|insulin aspart, insulin glulisine|single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp
16255500|NCT00969566|Drug|sitagliptin, metformin|sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.
16255501|NCT00969553|Drug|BI 6727|Dose level 1
16255502|NCT00969540|Device|Active Mattress Cover|Active Mattress Cover
16255503|NCT00969540|Device|Placebo Mattress Cover|Placebo Mattress Cover
16255504|NCT00969527|Dietary Supplement|Oncoxin + Viusid|50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
16255505|NCT00969527|Dietary Supplement|Placebo|50 ml of Placebo (orally administered) twice a day, for 12 weeks.
16255506|NCT00969501|Drug|EUFLEXXA|2.5 mL of EUFLEXXA (per injection) x 3 injections
16255507|NCT00969488|Other|High protein diet|"INTERVENTION is to stimulate the consumption of high protein foods and restrict the consumption of carbohydrates in the experimental group.
~The women in the intervention group will be incentivized to substitute breads and pastas for high protein foods (legumes, milk and its derivatives, eggs, fish, and lean meats)."
16255508|NCT00969475|Device|Lumenis fractional carbon dioxide laser|intra-operative laser resurfacing at time of wound closure
16255509|NCT00969462|Drug|Doxorubicin|measurements of serum Doxorubicin levels
16255510|NCT00969449|Drug|Naproxen Sodium, (BAY H6689)|One dose of Naproxen sodium extended release 660 mg under fasting conditions
16255511|NCT00969449|Drug|Naprelan, (BAY H6689)|One dose of Naprelan 500 mg (2 tablets) under fasting conditions
16255512|NCT00969436|Biological|GSK Biological's investigational MMRV vaccine 208136|Subcutaneous injection
16255513|NCT00969436|Biological|Priorix™|Subcutaneous injection
16255514|NCT00969436|Biological|Varilrix™|Subcutaneous injection
16255515|NCT00969423|Device|5mm videoscope|use of 5mm videoscope
16255516|NCT00969423|Device|10mm videoscope|use of 10mm videoscope
16255517|NCT00969410|Biological|AV-299|AV-299 will be given as an intravenous infusion in dose-escalating doses of 2, 10, and 20 mg/kg once every 2 weeks.
16255518|NCT00969397|Drug|Topical Antiangiogenic|Topical Antiangiogenic
16255519|NCT00969397|Device|Pulsed Dye Laser|Pulsed Dye Laser
16255520|NCT00969384|Behavioral|Active awareness/Lifestyle counseling|"Intervention (active awareness):
~In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided."
16255521|NCT00969371|Device|posterior chamber IOL implantation|
16255522|NCT00969371|Device|Experimental TetraFlex Study IOL|TetraFlex IOL implanted
16255523|NCT00969345|Other|Stretching Exercises|Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.
16255524|NCT00969345|Other|Respiratory Exercises conducted twice a day for 10 minutes|Conducted twice a week, with instructions for home exercises twice a day, and registering each session on a log sheet.
16255525|NCT00969332|Drug|Omegaven|0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday
16255526|NCT00969319|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Patients under daily life treatment receiving Kogenate according to local drug information.
16255527|NCT00969306|Drug|Chloroquine, A-CQ 100|"Administration:
~Orally
~Timing: Once daily
~Tablets of 100 mg
~During or after meals
~In case of missed dose: intake of the missed dose is still possible up until 12 hours before the next dose.
~Patients should always note date and time of intake on the chloroquine monitoring form."
16255528|NCT00969293|Drug|FOV2302 (Ecallantide)|"Single intravitreal injection into the relevant eye.
~Five dose levels will be studied from 5 to 90µg and a maximum of 6 subjects will be included at each dose level.
~Duration of Treatment: Single injection with 3 months follow-up."
16255529|NCT00969280|Device|Standardized Acupuncture|"Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks.
~According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle.
~All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes."
16255530|NCT00969280|Device|Non-acupuncture point shallow penetration acupuncture|"Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks.
~Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes."
16255531|NCT00969267|Other|ear-acupuncture A|with needle stimulation
16255532|NCT00969267|Other|stimulation B|with bread stimulation on ear acupuncture point
16255533|NCT00969267|Other|stimulation C|without needle stimulation
16255534|NCT00969254|Drug|Pílulas de Lussen|"Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
~* Drug A: Pílulas de Lussen®
~** Drug B: placebo."
16255535|NCT00969254|Drug|Pyridium®|"Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
~* Drug A: Pyridium®
~** Drug B: placebo."
16255536|NCT00969228|Biological|Rotarix ™|Two oral doses
16255537|NCT00969228|Biological|Placebo|Two oral doses
16255538|NCT00969215|Device|Lumenis fractional carbon dioxide laser|Laser resurfacing of a burn scar
16255539|NCT00969202|Radiation|Stereotactic Radiosurgery using the Novalis Tx|Five treatments given every other day.
16255540|NCT00969176|Drug|paracetamol|Intravenous paracetamol administration in neonates, loading dose 20 mg/kg, followed by a Gestational age-dependent maintenance dose of 10-20 mg/kg/24 h, divided in 4 doses (each 6h)
16255541|NCT00969163|Drug|testosterone gel|300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
16255542|NCT00969163|Drug|Comparator: placebo|transdermal placebo gel for 6 weeks
16255543|NCT00969150|Drug|Levomilnacipran ER|Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.
16255544|NCT00969150|Drug|Placebo|Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
16255545|NCT00969137|Drug|saline|intravenous saline
16255546|NCT00969137|Drug|Nicotine|Intravenous nicotine
16255547|NCT00969124|Device|Third Eye Retroscope|Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
16255548|NCT00969111|Radiation|IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE|Postop High Risk
16255549|NCT00969111|Radiation|Proton (prostate bed) to 70.2 CGE|Salvage Non-High Risk
16255550|NCT00969111|Radiation|IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE|Salvage High Risk
16255551|NCT00969111|Radiation|Proton to 66.6 CGE|Post-Op Non High Risk
16255552|NCT00969085|Drug|Curcumin (Turmeric)|"Chew then swallow 2 sticks per day for up to 6 months.
~2 sticks = 1 packet of curcumin = 8 grams"
16255553|NCT00969085|Behavioral|Questionnaires|Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit.
16255554|NCT00969085|Other|Photos|Photos of up to 6 selected skin lesion(s) and half-body photos taken on Day 1, Weeks 2, 4, 12, and at end of treatment visit.
16255555|NCT00969072|Drug|GI198745 0.05mg|GI198745 (drug) - benign prostatic hyperplasia
16255556|NCT00969072|Drug|GI198745 0.5mg|GI198745 (drug) - benign prostatic hyperplasia
16255557|NCT00969072|Drug|GI198745 2.5mg|GI198745 (drug) - benign prostatic hyperplasia
16255558|NCT00969059|Drug|GW856553|GW856553 is a film coated white tablet, 9mm round, biconvex, plain faced. It will be administered 7.5mg bid, orally with food at breakfast and dinner.
16255559|NCT00969059|Drug|PLACEBO|Matching Placebo is a film coated white tablet, 9mm round, biconvex, plain faced. It will be administered orally with food at breakfast and dinner.
16255560|NCT00969046|Drug|EPO906 (patupilone)|
16255561|NCT00969033|Drug|CS-1008|CS-1008
16255562|NCT00969033|Drug|irinotecan|irinotecan
16255563|NCT00969020|Procedure|remote rehabilitation support|An information technology solution containing RRS. The way it supports,, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.
16255564|NCT00969007|Behavioral|Lifestyle modification counselling|Patients meet individually every six weeks, a nurse or kinesiologist, and a dietitian (as well as a psychologist, if needed) and every three months an endocrinologist. A unique patient chart is shared by members of the interdisciplinary team, allowing sharing of the information and avoiding repetitions. Individualized behavioural intervention is proposed and focuses on attainable goals and progressive but sustained small changes in nutrition and physical activity. In addition, the participants have access to 24 weekly group seminars, on different aspects of excess weight and modification of lifestyle, to reinforce behaviour and commitment to lifestyle changes. Our approach meets all criteria suggested for clinical intervention in the 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children.
16255565|NCT00968994|Device|The exSALT™ SD7 Wound Dressing|The exSALT™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
16255566|NCT00968994|Device|Xeroform® Petrolatum Dressing|Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
16255567|NCT00968981|Drug|GDC-0449|Daily oral repeating dose
16255572|NCT00968955|Drug|Ropivacaine|Local infiltration with ropivacaine 0,2% (150 ML)
16255573|NCT00968942|Drug|Botulinum Toxin Type A|RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
16255574|NCT00968942|Drug|Placebo|Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
16255575|NCT00968929|Drug|Recombinant Streptokinase|Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours
16255576|NCT00968929|Drug|Urokinase|Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours
16255577|NCT00968916|Drug|ombrabulin (AVE8062)|"Pharmaceutical form: injection solution
~Route of administration: intravenous infusion"
16255578|NCT00968903|Drug|Methylprednisolone|Methylprednisolone 125 mg iv pre-operatively
16255579|NCT00968890|Biological|Pandemrix (Influenza vaccine GSK2340272A)|Intramuscular injection, 2 doses
16255580|NCT00968890|Biological|Fluarix™|Intramuscular injection, 1 dose
16255581|NCT00968890|Biological|Placebo|Intramuscular injection, 1 dose
16255582|NCT00968877|Drug|Cholecalciferol|capsule 40 000 IU (p.o.) once per week, in 8 weeks.
16255583|NCT00968864|Device|CliniMACS® (T cell depletion)|Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells.
16255584|NCT00968851|Drug|EVP-6124|Arms: 1
16255585|NCT00968851|Drug|Placebo|Arm: 3
16255586|NCT00968851|Drug|EVP-6124|Arms: 2
16255587|NCT00968838|Procedure|White Blood Cell Transfusion|"4 Transfusions, each taking approximately 1 hour:
~Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions.
~Patients >50 years of age are randomized to receive either radiated or non radiated transfusions."
16255588|NCT00968825|Drug|Botulinum Toxin Type A|RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines
16255589|NCT00968825|Drug|Placebo|Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines
16255590|NCT00968812|Drug|Glimepiride|Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
16255591|NCT00968812|Drug|Canagliflozin (JNJ-28431754)|Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
16255592|NCT00968812|Drug|Metformin|Metformin will be given orally at the protocol-specified dose for 104 weeks.
16255593|NCT00968799|Procedure|Hyperthermic intraoperative intraperitoneal chemotherapy|Perfusion of the peritoneum with 42°C warm 25 mg/l cisplatin solution.
16255594|NCT00968799|Procedure|Cytoreduction|"Surgical removal of tumor nodules
~including resection of organs infested with tumor"
16255595|NCT00968799|Drug|Cisplatin|Cisplatin is applied as chemotherapy during surgery
16255596|NCT00968786|Device|Home monitoring|automated measuring devices for patients using at home
16255597|NCT00968773|Device|Rebound HRD|Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
16255598|NCT00968773|Device|Standard hernia mesh (VitaMesh)|Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation
16255599|NCT00968760|Procedure|Leukapheresis|"Leukapheresis #1 - For Collecting T Cells
~Leukapheresis #2 - For Collecting Stem Cells, month following #1
~Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete."
16255600|NCT00968760|Procedure|Stem Cell Transplant|Stem cell infusion by vein over 30-45 minutes on Day 0
16255601|NCT00968760|Procedure|CD19-specific T Cell Infusion|T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7.
16255602|NCT00968760|Drug|IL-2|Group 2 or 4, IL-2 dose of 0.3 x 10^6 U/m^2 injected under skin, once a day for up to 14 days; first dose on day of T cell infusion.
16255603|NCT00968760|Drug|Carmustine|300 mg/m^2 IV over 1 hour on Day -6
16255604|NCT00968760|Drug|Etoposide|200 mg/m^2 IV over 3 hours every 12 hours on Days -5 to -2
16255605|NCT00968760|Drug|Cytarabine|200 mg/m^2 by vein over 1 hour every 12 hours on Days -5 to -2.
16255606|NCT00968760|Drug|Melphalan|140 mg/m^2 IV over 30 minutes on Day -1
16255607|NCT00968747|Behavioral|Fasting|Participants will fast for 72 hours and may consume only water and vitamins.
16255608|NCT00968747|Behavioral|Fasting|Participants will fast for 72 hours and may consume only water and vitamins.
16255609|NCT00968747|Behavioral|Diet|Participants will follow a low-calorie diet until they lose 3-5% of their body weight.
16255610|NCT00968747|Dietary Supplement|oral carbohydrate challenge|Participants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both
16255611|NCT00968734|Dietary Supplement|colecalciferol|50.000UI single oral dose
16255612|NCT00968708|Drug|Alogliptin|Alogliptin tablets
16255613|NCT00968708|Drug|Placebo|Alogliptin placebo matching tablets
16255614|NCT00968695|Drug|Albumin|The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.
16255615|NCT00968682|Biological|trastuzumab|
16255616|NCT00968682|Other|laboratory biomarker analysis|
16255617|NCT00968682|Procedure|assessment of therapy complications|
16255618|NCT00968669|Biological|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
16255619|NCT00968669|Biological|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
16255620|NCT00968669|Biological|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
16255621|NCT00968669|Other|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
16255622|NCT00968656|Radiation|PET/CT|Patients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection.
16255660|NCT00968396|Procedure|Stem Cell Transplantation|Co-culture Stem Cell Infusion on Day 0.
16255623|NCT00968656|Other|Laboratory Testing|Blood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions
16255624|NCT00968656|Other|Safety Testing|ECG tracings, and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during, and after the imaging sessions.
16255625|NCT00968656|Other|Immunohistochemistry staining|If available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors
16255626|NCT00968656|Drug|F-18-ISO|Patients receive F-18-ISO-1 i.v.
16255627|NCT00968643|Radiation|radiation therapy|Given in multiple fractions or as a single fraction
16255628|NCT00968630|Other|Laboratory Biomarker Analysis|Correlative studies
16255629|NCT00968630|Procedure|Leukapheresis|Undergo leukapheresis
16255630|NCT00968617|Drug|MK2578|MK2578 1.0 mcg/kg/month
16255631|NCT00968617|Drug|MK2578|MK2578 2.0 mcg/kg/month
16255632|NCT00968617|Drug|MK2578|MK2578 3.6 mcg/kg/month
16255633|NCT00968617|Drug|Comparator: darbepoetin alfa|darbepoetin alfa
16255634|NCT00968604|Genetic|BikDD Nanoparticle|Starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
16255635|NCT00968591|Drug|Everolimus|
16255636|NCT00968578|Drug|Methylprednisolone|Methylprednisolone 125 mg iv pre-operatively
16255637|NCT00968578|Drug|Placebo|Saline iv pre-operatively in equivalent volume (placebo)
16255638|NCT00968565|Drug|sodium citrate|Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit
16255639|NCT00968552|Procedure|Self-expandable stent placement via endoscopy|Self-expandable stent placement via endoscopy
16255640|NCT00968539|Biological|GSK investigational vaccine GSK2340272A|Two intramuscular injections
16255641|NCT00968539|Biological|GSK investigational vaccine GSK2340269A|Two intramuscular injections
16255642|NCT00968526|Biological|GSK investigational vaccine GSK2340272A|One or two intramuscular injections in the deltoid region of the non-dominant or the dominant arm.
16255643|NCT00968513|Behavioral|Brief Intervention|(N=475) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization
16255644|NCT00968513|Behavioral|Extended Treatment|(N=475) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
16255645|NCT00968513|Behavioral|Usual Care|brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
16255646|NCT00968500|Behavioral|Questionnaires/Interviews|"Prior to the interview, the measure of prolonged grief disorder symptoms, the PG-13, will be re-administered to participants as a quality assurance check. We will administer 7 self-report measures, which participants can complete in our office, at home, or via telephone, depending on their preferences. These questionnaires should take approximately 75 to 80 minutes to complete. If you are asked to take part in the in-depth interview and you choose to take part, the interview that will take approximately 60 to 90 minutes to complete, depending on the length of the responses to the questions asked.
~The participant may also be asked if they would be willing to fill out an additional questionnaire about parents' thoughts on the most appropriate timing for raising the topic of a postmortem examination and factors that are important to include in discussions. Despite its importance, autopsy is often not discussed with parents whose child is dying from cancer."
16255647|NCT00968487|Biological|Lyophilized Plasma|Lyophilized Plasma is serves as a source of plasma proteins for subjects who are deficient in plasma proteins. The donor and recipient are the same person, therefore the process is autologous. HemCon's lyophilized plasma originates from FFP from screened individual donors to significantly reduce the risk of bloodborne disease transmission and undesired transfusion-associated reactions. Each single-donor unit is tested (per required of the blood supply) to reduce the risk of transmission of infectious agents and hence, maximize subject safety.
16255648|NCT00968487|Other|Fresh Frozen Plasma|The fluid portion of one unit of human blood that has been centrifuged, separated, and frozen solid at -18 °C (-0.4 °F) (or colder) within 6 hours of collection.
16255649|NCT00968461|Drug|Phenethyl Isothiocyanate (PEITC)|Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle.
16255650|NCT00968448|Behavioral|Respiratory muscle training|Daily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels).
16255651|NCT00968448|Behavioral|Sham training|Sham training with same handheld device. 50 breaths daily on the lowest level
16255652|NCT00968435|Other|bevacizumab, cisplatin, cetuximab, radiation therapy|Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions. A total dose of 70Gy is planned for the primary tumor site over approximately 33 treatment days. Day 1 will refer to the first day of radiation therapy. Concurrent with radiation therapy, patients will receive cisplatin (50 mg/m2 IV on Days 1, 2 and 22, 23) and bevacizumab (15 mg/kg IV on Days 1 and 22). Cetuximab will be administered according to the Bonner regimen (4),with a loading dose approximately 7 days prior to the start of radiation therapy (400 mg/m2 IV once, on approximately Day minus 7), followed by weekly cetuximab infusions (250 mg/m2 IV weekly X 7 infusions) until the completion of radiation therapy.
16255653|NCT00968422|Drug|ABT-384|3 escalating doses will be administered daily for 21 days
16255654|NCT00968422|Drug|Matching placebo to ABT-384|Doses will be administered daily for 21 days
16255655|NCT00968409|Radiation|PET|PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer
16255656|NCT00968409|Other|Laboratory Testing|Blood and urine samples for standard laboratory testing and radioactive counts will be obtained during the imaging sessions. Testing will include: urinalysis, complete blood count, comprehensive metabolic panel, and progesterone levels
16255657|NCT00968409|Other|Safety Testing|ECG tracings and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during and after the imaging sessions.
16255658|NCT00968409|Drug|F18-FFNP|injection of F18-FFNP
16255659|NCT00968396|Procedure|Apheresis|On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.
16255661|NCT00968396|Drug|Melphalan|100 mg/m^2 IV over 30 minutes daily on Days -2 and -1
16255662|NCT00968383|Drug|Beta adrenergic blockers|Participants will receive beta adrenergic blockers.
16255663|NCT00968383|Drug|Platelet inhibitors|Participants will receive platelet inhibitors.
16255664|NCT00968383|Drug|Statins|Participants will receive statins.
16255665|NCT00968383|Drug|ACE inhibitors and/or ARB and/or AA|Participants will receive ACE inhibitors and/or ARB and/or AA
16255666|NCT00968383|Procedure|PCI with stenting|Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
16255667|NCT00968370|Other|Day-care clinic|Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.
16255668|NCT00968370|Other|Hospital Management|Inj. Ceftriaxone and other micronutrients will be given to children at the hospital from admission till discharge.
16255669|NCT00968357|Drug|SCV-07|"SCV-07 dosage will remain the same throughout the study for each cohort. Monotherapy Lead-in Phase Treatment (SCV-07) for 4 weeks. Combination Treatment (SCV-07 and ribavirin) for 4 weeks, following Lead-in Phase. Re-treatment with peg INF and RBV will be offered in the Follow-up to patients who in the opinion of the investigator may benefit from treatment. All patients will have a total of 3 follow-up visits for safety assessments. Women of childbearing potential will be followed up monthly for approximately up to 6 months after the end of treatment visit. If pregnancy occurs within the follow-up period, it needs to be followed through 8 weeks after the end of pregnancy."
16255670|NCT00968344|Dietary Supplement|Leucine|3-4g Leucine added to daily meals
16255671|NCT00968344|Dietary Supplement|Alanine|Powered amino acid
16255672|NCT00968331|Drug|Lenalidomide plus Rituximab|Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.
16255673|NCT00968318|Procedure|Excision of strip of deep fascia|operative technique to excise deep fascia.
16255674|NCT00968292|Device|Experimental prosthetics foot (K3 Promoter)|The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time.
16255675|NCT00968266|Behavioral|Patient-centered group intervention|"Session 1: Group discussion about the personal barriers for medication adherence. Supervisor: Pharmacist. Duration: 90 minutes. Goal: After this session the patient is aware of the benefits and barriers of adherence. The individual barriers to adherence (concerns and practical problems) and necessity beliefs about medication are identified and discussed.
~Session 2: Group based education on benefits of medication and discussing personal concerns about medication, practical barriers and beliefs about the necessity of medication. Supervisor: Pharmacist and rheumatologist. Duration: 90 minutes. Goal: Improving realistic beliefs about medication, stimulating an equal relationship between patient and health professional and motivating patients to be adherent."
16255676|NCT00968253|Drug|Everolimus (RAD001)|Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.
16255677|NCT00968253|Drug|Cyclophosphamide|300 mg/m^2 intravenous (IV) over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2).
16255678|NCT00968253|Drug|Vincristine|2 mg IV on Day 4 and Day 11 ± 2 days.
16255679|NCT00968253|Drug|Doxorubicin|50 mg/m^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.
16255680|NCT00968253|Drug|Dexamethasone|40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.
16255681|NCT00968253|Drug|Mesna|600 mg/m^2 IV continuous infusion daily for 24 hours days 1-3.
16255682|NCT00968253|Drug|Methotrexate|200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours day 1.
16255683|NCT00968253|Drug|Ara-C (Cytarabine)|3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
16255684|NCT00968253|Drug|Methylprednisone|50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.
16255685|NCT00968253|Drug|G-CSF|10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.
16255686|NCT00968240|Drug|Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB|"This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival of patients with relapsed/refractory GBM/AA.
~Day 0: Intraarterial Avastin single dose (starting at 2mg/kg and up to 10mg/kg) after Mannitol to open the blood brain barrier."
16255687|NCT00968227|Biological|Red blood cell transfusion|Transfusion of 1 unit of packed red blood cells over 1 hour.
16255688|NCT00968214|Genetic|polymorphism analysis|
16255689|NCT00968214|Other|laboratory biomarker analysis|
16255690|NCT00968201|Drug|montelukast sodium|one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
16255691|NCT00968201|Drug|Comparator: Placebo|one chewable placebo tablet, once daily at bedtime for 12 weeks
16255692|NCT00968188|Behavioral|Keep It Up!|Online HIV Intervention Prevention Website tailored to Young Men that Have Sex with Men. Website is tailored to be more engaging, includes videos and games.
16255693|NCT00968188|Behavioral|Information only|Medically fact based HIV information delivered online.
16255694|NCT00968175|Procedure|Ultrasound guided celiac plexus neurolysis (CPN)|Initial procedure and rescue procedure if applicable
16255743|NCT00967759|Drug|Bronpheniramine isolated|Oral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
16255818|NCT00967252|Drug|Atorvastatin|Atorvastatin 10 mg daily or equivalent dose in another statin
16255695|NCT00968162|Drug|fludarabine|Conduct a pilot trial using a transplant protocol, in which the standard busulfan, cyclophosphamide and anti-thymocyte globulin conditioning regimen is modified by adding fludarabine, a highly immunosuppressive agent, in order to determine the feasibility of reducing the total dose of cyclophosphamide from its present standard of 200 mg/kg to 90 mg/kg and of busulfan from its present standard of 12.8 mg/kg (IV) to 6.4 mg/kg, using a four step dose de-escalation schema.
16255696|NCT00968149|Drug|montelukast sodium|one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
16255697|NCT00968149|Drug|Comparator: Placebo|one placebo chewable tablet daily at bed time for 2 weeks
16255698|NCT00968110|Drug|omalizumab|Dosing table established for omalizumab
16255699|NCT00968097|Drug|123-I MNI-340|To assess the dynamic uptake and washout of 123-I MNI-340, a potential imaging biomarker for β-amyloid burden in brain
16255700|NCT00968071|Drug|Decitabine|20 mg/m^2 IV over an hour and half daily for 5 days.
16255701|NCT00968071|Drug|Gemtuzumab Ozogamicin|3 mg/m^2 IV on day 5.
16255702|NCT00968058|Procedure|Leak Test Recording|Recording of the Leak Pressure by the Leak Test at 0, 5, 10, 15, 20, 30 min timepoints
16255703|NCT00968045|Drug|Fibrinogen|Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
16255704|NCT00968032|Device|Nit-Occlud® PFO|Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
16255705|NCT00968019|Device|Presillion stent|Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
16255706|NCT00968006|Drug|Sitagliptin|100 mg once daily for 4 weeks
16255707|NCT00967993|Drug|ferric citrate|KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate
16255708|NCT00967980|Procedure|Femoral Nerve Block vs. Psoas Compartment Nerve Block|Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block. Patients randomized to femoral nerve block will receive this block prior to surgery. Patients randomized to psoas compartment nerve block will receive this block prior to surgery. Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
16255709|NCT00967967|Drug|Medication Mometasone furoate and desloratadine|One month treatment with both drugs
16255710|NCT00967954|Drug|antiandrogen therapy|
16255711|NCT00967954|Drug|releasing hormone agonist therapy|
16255712|NCT00967954|Genetic|DNA analysis|
16255713|NCT00967954|Genetic|RNA analysis|
16255714|NCT00967954|Genetic|comparative genomic hybridization|
16255715|NCT00967954|Genetic|gene expression analysis|
16255716|NCT00967954|Other|laboratory biomarker analysis|
16255717|NCT00967954|Procedure|diffusion-weighted magnetic resonance imaging|
16255718|NCT00967954|Procedure|magnetic resonance spectroscopic imaging|
16255719|NCT00967928|Drug|RAD001|RAD001 will be administered orally as 5 mg qod, 5 mg qd, or 10mg qd continuously from study Day 1 until the end of whole pelvic radiation therapy unless the patient develops progression of disease or unacceptable toxicity prior to that.
16255720|NCT00967928|Drug|Cisplatin|Cisplatin will be administered intravenously once weekly at 40mg/m2 for 6 weeks. The preferred administration day is Monday.
16255721|NCT00967928|Radiation|External Beam Whole Pelvis Radiation Therapy|Patients will receive 180 cGy daily fraction Monday through Friday x 25 days (4500 cGy total) using a four field technique throughout the entire treatment with all fields treated each day.
16255722|NCT00967915|Procedure|Frentomy|Frenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth.
16255723|NCT00967915|Other|Sham procedure|Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.
16255724|NCT00967902|Device|coronary stenting|Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs
16255725|NCT00967889|Genetic|gene expression analysis|
16255726|NCT00967889|Genetic|protein analysis|
16255727|NCT00967889|Other|biologic sample preservation procedure|
16255728|NCT00967889|Other|laboratory biomarker analysis|
16255729|NCT00967863|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
16255730|NCT00967863|Radiation|intensity-modulated radiation therapy|Patients undergo radiotherapy
16255731|NCT00967850|Drug|Intravitreal Injection|Intravitreal injection of 1,25 mg in 0,05 ml
16255732|NCT00967850|Drug|Photodynamic Therapy (Visudyne)|Photodynamic therapy on day 1 as described in standard clinical guidelines.
16255733|NCT00967837|Procedure|Pulsatile Intravenous Insulin Therapy|Diabetic pts that meet trial criteria referred by an endocrinologist are given Pulsatile intravenous insulin therapy on a weekly basis. Weekly orders for insulin dosage is based upon pt response to therapy monitored by RQ and insulin resistance.
16255734|NCT00967824|Other|informational intervention|
16255735|NCT00967824|Other|questionnaire administration|
16255736|NCT00967824|Other|survey administration|
16255737|NCT00967811|Drug|Formulation E1 of L-PPDS|Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
16255738|NCT00967811|Drug|Formulation E2 of L-PPDS|Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
16255739|NCT00967798|Drug|Sitagliptin|100 mg of sitagliptin is taken orally each morning with breakfast. Duration is 12 months or conversion to CF diabetes, whichever comes first.
16255741|NCT00967772|Drug|Naftopidil|25mg/ 50 mg/ 75mg dosage tablets
16255742|NCT00967759|Drug|Bronpheniramine and fenilefrine (Decongex Plus)|Oral Solution: Bronpheniramine (2mg/ml) and fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
16255817|NCT00967265|Other|Usual care|Usual care
16255744|NCT00967759|Drug|Fenilefrine isolated|Oral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
16255745|NCT00967746|Drug|Etonogestrel-releasing IUS|Low dose; treatment duration of 6 months with a possible extension to 12 months
16255746|NCT00967746|Drug|Etonogestrel-releasing IUS|Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
16255747|NCT00967746|Drug|Etonogestrel-releasing IUS|High dose; treatment duration of 6 months with a possible extension to 12 months
16255748|NCT00967746|Device|Multiload-cu 375®|Duration of 6 months with a possible extension to 12 months
16255749|NCT00967733|Dietary Supplement|Flaxseed oil-Olive oil|2 or 4 gr per day alpha-linolenic acid pill and olive oil used for cooking
16255750|NCT00967733|Dietary Supplement|Olive oil-olive oil|1 gr olive oil pill and olive oil used for cooking
16255751|NCT00967733|Dietary Supplement|Flaxseed oil-sunflower oil|2 or 4 gr per day alpha linolenic acid pill and sunflower oil used for cooking
16255752|NCT00967733|Dietary Supplement|Olive oil-sunflower oil|1 gr olive oil pill and sunflower oil used for cooking
16255753|NCT00967707|Drug|gabapentin and venlafaxine|"Week 1-6: Gabapentin monotherapy (titration to individual maximum tolerated dose or maximum 800 mg 3 times daily).
~Week 7-12: Venlafaxine 75 mg once daily is added."
16255754|NCT00967707|Drug|gabapentin and donepezil|"Week 1-6: Gabapentin monotherapy (titration to individual maximum tolerated dose or maximum 800 mg 3 times daily).
~Week 7-12: Donepezil 5 mg once daily is added."
16255755|NCT00967694|Drug|Nitrous oxide|Nitrous oxide sedation by inhalation
16255756|NCT00967681|Dietary Supplement|Oncoxin|(caplets 300 mg), three oral caplets per day for 24 weeks
16255757|NCT00967681|Dietary Supplement|Placebo|(caplets 300 mg), three oral caplets per day for 24 weeks
16255758|NCT00967668|Behavioral|Small change approach to improve physical activity and diet|"The Aspire to Lifelong Health (ASPIRE) initial treatment program draws on the strengths of traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week in the program, participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle."
16255759|NCT00967668|Behavioral|MOVE! Usual Care|The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
16255760|NCT00967655|Biological|panitumumab|
16255761|NCT00967655|Drug|capecitabine|
16255762|NCT00967655|Drug|irinotecan hydrochloride|
16255763|NCT00967655|Procedure|neoadjuvant therapy|
16255764|NCT00967655|Procedure|therapeutic conventional surgery|
16255765|NCT00967655|Radiation|radiation therapy|
16255766|NCT00967642|Drug|Intravenous Insulin|continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl
16255767|NCT00967629|Drug|Sevelamer Carbonate|This is a 4 month, prospective, comparative, crossover study. The study will be conducted in 20 patients with stage II, III or stage IV diabetic nephropathy. Patients will be randomized 1:1 to receive either 1,250 mg of calcium carbonate TID with meals (control arm) or Sevelamer Carbonate 1,600 mg (two 800 mg tablets) with meals. Each group of 10 subjects will take the assigned drug for 8 weeks. Following the 8 week treatment period, subjects will discontinue the assigned drug for a one week washout period. Following the washout period, those who were taking calcium carbonate will be crossed over to Sevelamer Carbonate therapy and those who were receiving Sevelamer Carbonate will be crossed over to calcium carbonate for a final 8 week treatment phase.
16255768|NCT00967629|Drug|Calcium Carbonate|This is a 4 month, prospective, comparative, crossover study. The study will be conducted in 20 patients with stage II, III or stage IV diabetic nephropathy. Patients will be randomized 1:1 to receive either 1,250 mg of calcium carbonate TID with meals (control arm) or Sevelamer Carbonate 1,600 mg (two 800 mg tablets) with meals. Each group of 10 subjects will take the assigned drug for 8 weeks. Following the 8 week treatment period, subjects will discontinue the assigned drug for a one week washout period. Following the washout period, those who were taking calcium carbonate will be crossed over to Sevelamer Carbonate therapy and those who were receiving Sevelamer Carbonate will be crossed over to calcium carbonate for a final 8 week treatment phase.
16255769|NCT00967616|Drug|CS7017|CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks.
16255770|NCT00967616|Drug|irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)|"FOLFIRI will be administered IV once every 2 weeks.
~The FOLFIRI regimen consists of:
~Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes
~Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion
~5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)"
16255771|NCT00967603|Drug|sunitinib|oral sunitinib 37.5 mg daily
16255772|NCT00967590|Drug|RO5036505|380mg iv infusion once weekly for 8 weeks
16255773|NCT00967590|Drug|placebo|iv infusion once weekly for 8 weeks
16255774|NCT00967577|Drug|177Lu-J591|70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
16255775|NCT00967564|Other|epidemiologic study|QoL assessment
16255776|NCT00967551|Dietary Supplement|Micronutrient Sprinkles with zinc|Daily dose of 1 packet of sprinkles
16255777|NCT00967551|Dietary Supplement|Micronutrient sprinkles without zinc|I packet of micronutrient sprinkles without zinc
16255778|NCT00967538|Drug|etanercept 50 mg|All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
16255779|NCT00967525|Procedure|cord blood infusion|Receive two cord blood units. One administered by intraosseous infusion and the other by intravenous infusion. The second unit is being given as a safeguard, but will also allow the researchers to directly compare engraftment between intravenously and intraosseously infused cord blood units.
16255780|NCT00967512|Drug|cenersen|solution for injection, intravenous infusion, 0.1 mg/kg/h x 24h x 4 days, and 0.4 mg/kg/h x 3h x 4 days
16255781|NCT00967512|Drug|placebo|solution for injection, intravenous infusion, 0.1 mg/kg/h x 24h x 4 days, and 0.4 mg/kg/h x 3h x 4 days
16255782|NCT00967512|Drug|idarubicin, cytarabine|idarubicin, cytarabine
16255783|NCT00967499|Drug|Ondansetron|"Subjects will receive ondansetron 4 mg intravenously (IV) and will be followed for 72 hours.
~Ondansetron is a selective 5-HT3 receptor antagonist. It is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin and prevention of postoperative nausea and/or vomiting."
16255784|NCT00967499|Drug|Palonosetron|"Subjects will receive palonosetron HCl 0.075 mg IV and will be followed for 72 hours.
~Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, and the prevention of postoperative nausea and vomiting for up to 24 hours following surgery."
16255785|NCT00967486|Procedure|Carotid endarterectomy with routine shount|
16255786|NCT00967486|Procedure|Carotid endarterectomy with selective shunt|
16255787|NCT00967473|Device|ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.|ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye.
16255788|NCT00967460|Behavioral|Lifestyle intervention|Promoting unstructured spontaneous physical in childcare through an adaptation of the built environment and the provision of a supportive social environment
16255789|NCT00967434|Drug|Atorvastatin|atorvastatin 80 mg daily for at least 7 preoperative days atorvastatin 80 mg on day of surgery atorvastatin 80 mg daily for up to 7 postoperative days
16255790|NCT00967434|Drug|Atorvastatin|Daily placebo on the preoperative days atorvastatin 80 mg on day of surgery atorvastatin 80 mg daily for up to 7 postoperative days
16255791|NCT00967434|Drug|Placebo|Daily placebo in preoperative period Placebo on day of surgery Daily placebo for up to 7 postoperative days
16255792|NCT00967421|Drug|ethanol|BAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.
16255793|NCT00967421|Drug|Ethanol|BAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.
16255794|NCT00967421|Other|Placebo drink|Placebo drink containing no alcohol + placebo pill
16255795|NCT00967408|Drug|Escitalopram|Rehabilitative treatment + Oral Escitalopram 5 mg/day for the first week, 10 mg/day from second to fourth week and 20 mg/day until 6th month.
16255796|NCT00967408|Drug|Placebo|Rehabilitative treatment + oral inactive placebo for 6 months
16255797|NCT00967408|Other|Rehabilitative treatment|Rehabilitative treatment
16255798|NCT00967395|Other|Healing|"Healing in our study is given be a healer no-touch, who just has to be present in the room."
16255799|NCT00967395|Other|Sham healing|"Sham Healing in our study is given be a student no-touch, who just has to be present in the room."
16255800|NCT00967382|Drug|dalteparin sodium|"Subject's randomize to treatment arm will receive dalteparin sodium 5,000 IU s.c. daily starting on randomization day until 20 weeks gestational age then;
~dalteparin sodium 5,000 IU s.c. bid from 20 weeks to onset of labour or 37 weeks gestation (discontinued at the discretion of the investigator/obstetrician)
~Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum"
16255801|NCT00967369|Drug|Bortezomib|Given IV
16255802|NCT00967369|Drug|Carboplatin|Given IV
16255803|NCT00967369|Drug|Etoposide|Given IV
16255804|NCT00967369|Drug|Ifosfamide|Given IV
16255805|NCT00967356|Drug|AZD5985|Single dose-The starting dose will be 40 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca predefined upper exposure limits
16255806|NCT00967356|Drug|Placebo|Oral suspension
16255807|NCT00967343|Biological|Donor lymphocyte preparation depleted of host functional alloreactive T-cells|Single intravenous infusion with 2x10E6 T-cells/kg
16255808|NCT00967330|Drug|bevacizumab [Avastin]|10mg/kg iv every 2 weeks
16255809|NCT00967330|Drug|irinotecan|125mg/m2 iv every 2 weeks
16255810|NCT00967330|Drug|temozolomide|75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
16255811|NCT00967317|Drug|Auris-Sedina|"Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases.
~The medication should be used for a maximum of 3 days when they should return to the doctor."
16255812|NCT00967317|Drug|Otosynalar®|Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.
16255813|NCT00967304|Other|"Application of theMen continue and HER DOO2 rule"|"Consecutive patients will have theMen continue and HER DOO2 rule applied by the attending physician between 5 - 12 months after treatment for a first unprovoked objectively proven major VTE.
~Men continue and HER DOO2 rule: all men continue oral anticoagulants and women with 2 or more of the following features after 5-7 months of OAT should continue oral anticoagulants:1) HER - any Hyperpigmentation, Edema and Redness of either lower extremity, 2) Vidas D-dimer ≥250ug/L, 3) Obesity - BMI ≥30 kg/m2 and 4) Older age - Age ≥65 years."
16255814|NCT00967291|Drug|ifosfamide|2,500 mg/mq on days 1-3 every 28 days
16255815|NCT00967291|Drug|mitomycin C|8 mg/mq on day 1 every 28 days
16255816|NCT00967265|Behavioral|Introduction seminar|The seminar will be held over two half days, each lasting 2.5 hours. Up to 30 patients can participate in each seminar. The details of the content of the program will be developed based on study one. The preliminarily plans are to give general information about the community mental health centre, the available treatment options and patients rights by presentations from health personnel and user representatives. At the end of each day, the patients will be divided into small groups mentored by health personnel were they can discuss the presentations and ask questions. In the breaks, literature and other type of information for patients will be on display. All participants will get a folder with details of the program and leaflets from patient organisations and governmental agencies.
16255819|NCT00967252|Drug|Atorvastatin|Atorvastatin 20 mg daily or equivalent dose in another statin
16255820|NCT00967252|Drug|Atorvastatin|Atorvastatin 40 mg daily or equivalent dose in another statin
16255821|NCT00967252|Drug|Atorvastatin|Atorvastatin 80 mg daily or equivalent dose in another statin
16255822|NCT00967252|Other|Control|No statin being taken
16255823|NCT00967239|Genetic|DNA analysis|
16255824|NCT00967239|Genetic|polymorphism analysis|
16255825|NCT00967239|Other|laboratory biomarker analysis|
16255826|NCT00967239|Other|pharmacogenomic studies|
16255827|NCT00967226|Drug|propranolol|propranolol 0.5 mg/kg orally, 4 per day - 4-6 months
16255828|NCT00967226|Drug|Prednisolone|1.0 mg/kg orally, 2 per day 4-6 months
16255829|NCT00967213|Drug|ranibizumab|Lucentis® (ranibizumab) 0.3mg (0.05ml volume) intravitreal injection. Eligible patients will be initially received three session of monthly injection of Lucentis® (week 0, 4, 8). After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks. Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
16255830|NCT00967200|Other|laboratory biomarker analysis|laboratory biomarker analysis
16255831|NCT00967200|Other|pharmacogenomic studies|pharmacogenomic studies
16255832|NCT00967187|Drug|bevirimat dimeglumine|Patients will be treated with MPC-4326 200mg monotherapy for 14 days. Once the Day 15 viral load results become available, patients, who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.
16255833|NCT00967187|Drug|bevirimat dimeglumine|Patients will be treated with MPC-4326, 300 mg monotherapy for 14 days. Once the Day 15 viral load results become available patients who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.
16255834|NCT00967174|Drug|Nicotine Patch|25 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days.
16255835|NCT00967174|Drug|Placebo Patch|Placebo Patch applied on the lower back, according to treatment sequence, daily for 21 days.
16255836|NCT00967174|Drug|SLS Comparator Patch|0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.
16255837|NCT00967161|Procedure|Total Knee Arthroplasty|Total Knee Arthroplasty
16255838|NCT00967161|Procedure|Motion analysis|Motion analysis (Gait/EMG during walking and functional tasks)
16255839|NCT00967148|Drug|Tinzaparin|The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.
16255840|NCT00967135|Drug|Pregabalin|150 mg oral dose of pregabalin twice daily for 5 consecutive days.
16255841|NCT00967135|Drug|Placebo|Matching oral placebo twice daily for 5 consecutive days.
16255842|NCT00967122|Procedure|Band adjustment and specimen collection|Clinical evaluation and sample collection before and after band adjustment
16255843|NCT00967109|Other|Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L|Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L
16255844|NCT00967109|Other|Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L|Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L
16255845|NCT00967096|Drug|Rifaximin|Rifaximin for Bone marrow transplant patients
16255846|NCT00967083|Behavioral|Questionnaires/Interviews|Baseline assessment of distressed caregivers within 4-6 weeks a new visit to the thoracic clinic. Three-month follow-up assessment of caregivers. Qualitative phone interviews with a subsample of 30 caregivers within 3 weeks of follow-up.
16255847|NCT00967070|Drug|Nicotine Patch|25 mg nicotine patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
16255848|NCT00967070|Drug|Placebo Patch|Placebo patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
16255849|NCT00967057|Drug|asparaginase|Given intramuscularly
16255850|NCT00967057|Drug|dexamethasone|Given orally
16255851|NCT00967057|Drug|idarubicin|Given IV
16255852|NCT00967057|Drug|methotrexate|Given intrathecally
16255853|NCT00967057|Drug|mitoxantrone hydrochloride|Given IV
16255854|NCT00967057|Drug|pegaspargase|Given intramuscularly
16255855|NCT00967057|Drug|vincristine sulfate|Given IV
16255856|NCT00967044|Drug|Panobinostat|Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week
16255857|NCT00967044|Drug|Everolimus|Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal.
16255858|NCT00967031|Drug|capecitabine|
16255859|NCT00967031|Drug|lapatinib ditosylate|
16255860|NCT00967031|Other|circulating tumor cell analysis|
16255861|NCT00967031|Other|laboratory biomarker analysis|
16255862|NCT00967018|Drug|Degarelix|
16255863|NCT00967005|Drug|N Acetyl Cysteine|N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
16255864|NCT00967005|Other|Sugar Pill|placebo control
16255865|NCT00966992|Drug|Zoledronic acid|
16255867|NCT00966966|Drug|SAM-531 and gemfibrozil|2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days
16255868|NCT00966953|Drug|Fluoride|Brush twice daily
16255869|NCT00966953|Drug|Triclosan/Fluoride toothpaste|Brush twice daily
16255870|NCT00966953|Drug|Fluoride|Brush twice daily
16255871|NCT00966953|Drug|Fluoride|Brush twice daily
16255872|NCT00966953|Other|antibacterial plant extract|Brush twice daily
16255873|NCT00966940|Drug|Travoprost 0.004% ophthalmic solution (TRAVATAN)|One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
16255874|NCT00966940|Drug|Tafluprost 0.0015% ophthalmic solution|One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
16255875|NCT00966914|Drug|Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel|Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks
16255876|NCT00966914|Drug|Placebo in combination with cisplatin and docetaxel or paclitaxel|Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks
16255877|NCT00966901|Drug|Nicotine Patch|25 mg nicotine patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
16255878|NCT00966901|Drug|Placebo Patch|As a positive control, a placebo patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
16255879|NCT00966901|Drug|No Patch Control|As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
16255880|NCT00966901|Radiation|UVA and UVB irradiation|All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
16255881|NCT00966888|Procedure|standard follow-up care|No intervention
16255882|NCT00966888|Radiation|radiation therapy|Chest wall radiotherapy
16255883|NCT00966875|Biological|LY2439821|Subcutaneous
16255884|NCT00966875|Drug|Placebo|Subcutaneous
16255885|NCT00966862|Other|Other: Dietary Fibers|
16255886|NCT00966849|Other|Conditional Cash Transfer|"Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions:
~An application for a birth certificate must be made for all children under 18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.
~All children under 5 years in the household must be up-to-date with vaccinations.
~All children under 5 years must attend a growth monitoring clinic twice per year.
~All children 6-17 years in the household attended school at least 90% of days in the last month.
~At least one adult from each household attended at least 2 of the 3 most recent parenting skills classes."
16255887|NCT00966849|Other|Unconditional Cash Transfers|Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash.
16255888|NCT00966849|Other|Standard Agricultural Package|A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study.
16255889|NCT00966849|Other|Parenting Skills Classes|2-3 parenting skills classes will be held annually in each study cluster.
16255890|NCT00966836|Drug|Pre-emptive strategy with valganciclovir plus everolimus|Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Everolimus plus cyclosporine and prednisone will be used for maintenance immunosuppression
16255891|NCT00966836|Drug|Prophylaxis with valganciclovir plus mycophenolate|Patients will receive 3 months of oral valganciclovir with mycophenolate and standard cyclosporine and prednisone for maintenance immunosuppression
16255892|NCT00966836|Drug|Prophylaxis with valganciclovir plus everolimus|Patients will receive valganciclovir for 3 months after transplant. Everolimus plus reduced cyclosporine and prednisone will be used for maintenance immunosuppression
16255893|NCT00966836|Drug|Pre-emptive mycophenolate|Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Mycophenolate plus standard cyclosporine and prednisone will be used for maintenance immunosuppression
16255894|NCT00966823|Device|Fetal tracheal obstruction with detachable balloon (device)|"Fetal tracheal obstruction with detachable balloon (device): Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
16255895|NCT00966810|Procedure|Stem cell transplantation|Patients were conditioned with oral busulfan 12mg/kg (days -6 to -4), cyclophosphamide 120mg/kg (days -3,-2), rabbit antithymocytic globulin, (Fresenius, Bad Hamburg, Germany) 25mg/kg (days -5 to -1) and fludarabine 200 mg/kg (days -7 to-3). CD34 cells were positively selected using anti-CD34 antibody conjugated to iron-dextran microbeads using CliniMACS device (Miltenyi Biotech, Bergisch Gladbach, Germany) with an aim to collect > 5.0 x 106 CD34 cells/kg. DLI was administered in escalating dose regimen starting from 3 x 106 cells/kg followed as necessary by 1 x 107 cells/kg, 5 x 107 cells/kg and 1 x 108 cells/kg.
16255896|NCT00966784|Other|Dietary Fibers|
16255897|NCT00966771|Drug|Copper T380 IUD|copper T 380 IUD
16255898|NCT00966771|Drug|Oral levonorgestrel|1.5 mg
16255899|NCT00966758|Procedure|Computed Tomography|1 low dose CT scan is taken
16255900|NCT00966758|Procedure|Single Photon Emission Computed Tomography|1 SPECT scan is taken
16255901|NCT00966745|Drug|milrinone|
16255902|NCT00966745|Drug|placebo|
16255903|NCT00966732|Behavioral|Yoga of Awareness Program|The 8 week yoga program will meet in groups of about 8-10 persons. Each 2-hour session will include gentle stretching, strengthening, and balance poses; meditation exercises; breathing techniques; study of pertinent topics (eg, mind/body stress reactivity), and group discussions (eg, experiences while practicing yoga). Participants will be asked to practice yoga methods at home, guided by a DVD (or audio recordings). The program will be taught by a certified yoga teacher (RYT) who has extensive experience in teaching yoga to medical patients.
16255904|NCT00966719|Other|Lactation Consultant support|Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice.
16255905|NCT00966706|Drug|capecitabine|Given systemically
16255906|NCT00966706|Drug|cisplatin|Given systemically
16255907|NCT00966706|Drug|docetaxel|Given systemically
16255908|NCT00966706|Drug|epirubicin hydrochloride|Given systemically
16255909|NCT00966706|Drug|gemcitabine hydrochloride|Given systemically
16255910|NCT00966693|Drug|Dexamethasone|Given PO
16255911|NCT00966693|Drug|Lenalidomide|Given PO
16255912|NCT00966693|Drug|Thalidomide|Given PO
16255913|NCT00966680|Other|Anesthesia|How long anesthesiologists take to administer general and spinal anesthesia.
16255914|NCT00966654|Drug|Placebo|1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.
16255915|NCT00966654|Drug|GLP-1 (7-36) amide|1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.
16255916|NCT00966641|Drug|Naproxen|Single orally administered dose of 500 mg naproxen
16255917|NCT00966641|Drug|PL 3100|Single orally administered dose of PL 3100 (500 mg naproxen)
16255918|NCT00966628|Drug|Hypertonic sodium lactate|Hypertonic sodium lactate 5 ml/kg BW administered within 15 minutes to restore hemodynamic status. If shock state did not recover with first infusion, study solution infused again at same dose. After recovery from shock state, patients receive maintenance dose at 1 mL/kgBW/hour for 12 hours. After 12 hr. infusion with study fluid, patients receive RL infusion as per standard protocol of DSS management at site.In case of repeated shock within 12 hours, study drugs can be infused again. If patient still not recovered from shock state, the patients will be given HES (Hydroxy-Ethyl Starch) infusion at dose of 20 mL/kgBW/15-30 min with maximum dose of 50 mL/kgBW/24 hours.
16255919|NCT00966628|Drug|Ringer's lactate|Ringer lactate infused at dose 20 mL/kgBW within 15 minutes to restore hemodynamic status. If shock state did not recover with first infusion, study fluid infused again at same dose. After recovery from shock, patient received maintenance dose of RL. In case of repeated shock, patients received HES (Hydroxy-Ethyl Starch) infusion at dose of 20 mL/kgBW/15-30 min with maximum dose of 50 mL/kgBW/24 hours.
16255920|NCT00966615|Other|double-chamber bag Stay-Safe Balance system|2-L exchange; three times a day
16255921|NCT00966615|Other|glucose-based dialysis solution|2-L exchange; three times a day
16255922|NCT00966602|Drug|VX-809|VX-809 capsule, once daily for 14 days
16255923|NCT00966602|Drug|VX-770|VX-770 tablet, once every 12 hours for 14 days
16255924|NCT00966602|Drug|VX-809 & VX-770|VX-809 capsule, once daily, and VX-770 tablets, once every 12 hours, for 14 days
16255925|NCT00966602|Drug|Placebo|Matching Placebo
16255926|NCT00966589|Procedure|laparoscopic hernioplasty (TEP)|Insertion of polypropylene mesh behind pubic bone
16255927|NCT00966576|Drug|Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)|1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks
16255928|NCT00966563|Drug|Mangafodipir|Administered dose: 2 µmol/kg b.w. Administration form: Ready-to-use formulation (solution). Mangafodipir or placebo (0.2 ml/kg b.w.) will be administered as an intravenous (iv.) infusion over 2-5 min prior to reopening of occluded coronary artery during PCI
16255929|NCT00966563|Drug|Placebo|
16255930|NCT00966550|Other|Tomato|Tomato with high carb/fat meal
16255931|NCT00966550|Other|Non-tomato|Non-tomato with high carb/fat meal
16255932|NCT00966524|Procedure|Endotracheal intubation|Pregraduates medical students will be randomized to perform endotracheal intubation with video-guided feedback (experimental arm) or endotracheal intubation using direct visualization feedback (standard technique).
16255933|NCT00966511|Procedure|Lung resection surgery|The study is designed in a way that will not alter the surgeon's decision based on routine assessment of candidates for resection (lobectomy or greater). Namely, the VRI data will be gathered prospectively; however, the analyses using VRI data will be performed retrospectively.
16255934|NCT00966498|Procedure|Peripheral Blood Stem Cell Transplant|Peripheral Blood Stem Cell Transplant
16255935|NCT00966485|Drug|80 mg ASA dosing|
16255936|NCT00966485|Drug|500 mg ASA dosing|
16255937|NCT00966472|Drug|Erlotinib + Rosuvastatin|Patients will receive Erlotinib 150mg po daily. They will also receive Rosuvastatin at escalating dose levels starting at 1mg/kg po daily for 3 weeks, followed by a 1-week rest period. Patients may continue to receive rosuvastatin and erlotinib in the absence of disease progression or unacceptable toxicity.
16255938|NCT00966459|Procedure|Computed Tomography|1 low-dose CT is taken
16255939|NCT00966446|Drug|Unsupervised Decolonization|Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.
16255940|NCT00966446|Drug|Supervised Decolonization|Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. In addition, households are contacted by study stuff via phone or text messages to ensure compliance, to provide reminders to household members to perform the decolonization protocol as well as to answer any question/concerns household members may have.
16255941|NCT00966433|Procedure|Spontaneous ventilation|The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
16255942|NCT00966433|Device|Pressure support Ventilation|The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
16255943|NCT00966433|Device|Pressure control ventilation|The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
16255944|NCT00966420|Device|traction assisted endoscopic mucosa resection|A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.
16255945|NCT00966381|Other|Exercise and weight loss intervention|randomized control trial, stratified by parity
16255946|NCT00966368|Drug|insulin degludec|Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)
16256159|NCT00964639|Drug|Saline|During the surgery infiltration with saline. Thereafter bolus 3 times a day
16255947|NCT00966368|Drug|insulin degludec|Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)
16255948|NCT00966355|Drug|Terlipressin|loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
16255949|NCT00966355|Drug|Somatostatin|loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
16255950|NCT00966355|Drug|Octreotide|loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
16255951|NCT00966342|Drug|Fluviral 2009/10|single dose given IM .05 mL
16255952|NCT00966329|Drug|maraviroc|HAART regimen including 2 NRTI/NtRTIs plus maraviroc
16255953|NCT00966329|Drug|control group|"HAART regimen including 2 NRTI/NtRTIs plus one of the following :
~1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir)
~or ATV/unboosted (in a regimen without tenofovir)
~or 1 NNRTI (nevirapine or efavirenz)."
16255954|NCT00966316|Drug|aspirin，chinese herbs；|aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd
16255955|NCT00966303|Other|Cardiac Rehabilitation with diaphragmatic muscle training|Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.
16255956|NCT00966290|Drug|Anticoagulant (warfarin, acenocoumarol, fluindione)|Anticoagulant clinic based shared-care group
16255957|NCT00966290|Drug|Anticoagulant (warfarin, acenocoumarol, fluindione)|Usual care group
16255958|NCT00966277|Drug|Dalteparin|5000 units subcutaneous, by injection under the skin, daily for 16 weeks
16255959|NCT00966264|Drug|LNG-IUS|LNG-IUS releasing 25 microg of levonorgestrel
16255960|NCT00966264|Procedure|Hysterectomy|operation
16255961|NCT00966251|Drug|CT-011|CT-011
16255962|NCT00966238|Biological|VAX125|STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI).
16255963|NCT00966225|Dietary Supplement|LIP-01|comparison of different dosages of natural health product
16255964|NCT00966212|Behavioral|parent education|Especially for Daughters audio-cd parent education
16255965|NCT00966199|Drug|anti-hypertensive medication|8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication
16255966|NCT00966186|Procedure|Insertion fo ProSeal laryngeal mask airway|Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique
16255967|NCT00966173|Device|SciBase III Electrical Impedance Spectrometer|Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.
16255968|NCT00966160|Drug|Lopinavir/Ritonavir plus Lamivudine/Zidovudine|400 mg lopinavir and 100 mg ritonavir (Kaletra capsules, Abbott Laboratories) twice daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks
16255969|NCT00966160|Drug|Efavirenz plus Lamivudine/Zidovudine|600 mg efavirenz (Sustiva tablets, Bristol-Myers Squibb) once daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks
16255970|NCT00966147|Other|Increasing oxygen delivery .|The target is increasing oxygen delivery above 600ml/min/mr2 by either bolus of iv colloid or a continuous infusion of dopamine, dobutamine or noradrenaline. The fluids and drug administration will be directed and monitored by the lidco system and transesophageal echocardiography.
16255971|NCT00966134|Other|exposure to high altitude|
16255972|NCT00966121|Procedure|endoscopic band ligation|"Perform EBL within 7 days after randomization
~Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment).
~Acid suppression using proton pump inhibitor until eradicated.
~After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months)."
16255973|NCT00966121|Procedure|EBL+Propranolol|"Start with 20 mg b.i.d
~Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min
~After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)"
16255974|NCT00966108|Device|SENSIMED Triggerfish|Ocular Telemetry Sensor for IOP monitoring
16255975|NCT00966082|Procedure|endoscopic band ligation|Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
16255976|NCT00966082|Procedure|endoscopic band ligation+Propranolol|Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
16255977|NCT00966069|Other|Parent collection|Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.
16255978|NCT00966069|Other|Healthcare worker home visit|Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.
16255979|NCT00966056|Drug|Mitomycin C|Cotton wick soaked with 1mg/ml of mitomycin c placed for 2 minutes between the raw surfaces after synechiolysis with surgical blade no.15
16255980|NCT00966056|Device|Teflon nasal septal splint|Teflon internal nasal septal splint placed between the raw surfaces and secured at the anterior end of septum with catgut 3-0 sutures, following synechiolysis with surgical blade no.15. Splint removed at the end of one week
16255981|NCT00966030|Drug|MK0974 tablet|MK0974 280 mg tablet in one of two treatment periods
16255982|NCT00966030|Drug|Comparator: MK0974 liquid filled capsule|MK0974 300 mg liquid filled capsule in one of two treatment periods
16255983|NCT00966004|Drug|YM178|oral
16255984|NCT00966004|Drug|Placebo|oral
16255985|NCT00966004|Drug|tolterodine|oral
16255986|NCT00965991|Drug|metformin|patients received glyburide initial dose of 500 mg PO BID. Increased as necessary to a maximum dose of 2000 mg QD to control blood glucose
16255987|NCT00965991|Drug|Glyburide|Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose
16255988|NCT00965978|Drug|ONO-5920 / YM529|oral
16256070|NCT00965172|Other|Caphosol|Oral rinse of calcium phosphate solution five times daily beginning on day one of chemotherapy.
16255989|NCT00965965|Behavioral|New colorectal cancer screening patient education document|The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.
16255990|NCT00965965|Behavioral|Traditional colorectal cancer screening education document|The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.
16255991|NCT00965926|Drug|YM178|oral
16255992|NCT00965913|Drug|Nicotine Patch|15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
16255993|NCT00965913|Drug|Nicotine Patch Comparator|15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
16255994|NCT00965913|Drug|Placebo Patch|Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days
16255995|NCT00965900|Procedure|Endoscopic band ligation|"Perform EBL within 7 days after randomization
~Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
~Acid suppression using proton pump inhibitor until eradicated.
~After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months)."
16255996|NCT00965900|Drug|Propranolol|"start with 20 mg of propranolol b.i.d
~Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
~After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)"
16255997|NCT00965900|Procedure|EBL+Propranolol|"EBL
~Perform EBL within 7 days after randomization
~Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment)
~Acid suppression using proton pump inhibitor until eradicated.
~After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
~Propranolol
~start with 20 mg b.i.d
~Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min
~After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)"
16255998|NCT00965887|Drug|MK0974 Ethanolate formulation|Single dose MK0974 280 mg tablet in one of two treatment periods
16255999|NCT00965887|Drug|Comparator: MK0974 Hydrate formulation|Single dose MK0974 280 mg tablet in one of two treatment periods
16256000|NCT00965874|Drug|Magnesium Sulfate high dose|9 g infusion once during 30 minutes
16256001|NCT00965874|Drug|Magnesium Sulfate low dose|4.5 g magnesium sulfate infusion
16256002|NCT00965874|Drug|Placebos|serum salin
16256003|NCT00965861|Other|Tissue Registry Study|If a patient consents to allowing the use of their tumor tissue sample(s) for testing/analysis at a future date, their name and information will be stored electronically in a registry that will be managed by SCRI. SCRI may then use the information contained in this registry (such as disease indication, demographic information, etc.) at any time in the future to select tissue samples on which to perform testing/analyses.
16256004|NCT00965848|Drug|Doripenem|Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
16256005|NCT00965822|Other|North American ginseng|3 day, once daily, dosing
16256006|NCT00965822|Other|Placebo|3 day, once daily dosing
16256007|NCT00965809|Drug|Tetrahydrocannabinol|Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
16256008|NCT00965809|Other|Placebo|Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
16256009|NCT00965796|Drug|Lidocaine|Lidocaine 2 mg/kg/h- during surgical procedure Saline
16256010|NCT00965783|Other|Restriction|Time in bed for each subject is restricted by two hours per night for 4 nights
16256011|NCT00965783|Other|Extension|Bedtime is extended by 2 hours per night for 4 nights
16256012|NCT00965770|Device|Intrauterine device (IUD)|Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion
16256013|NCT00965757|Drug|T-614|T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.
16256014|NCT00965757|Drug|Placebo|Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.
16256015|NCT00965744|Device|Vessel sealing system LigaSure|Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.
16256016|NCT00965731|Drug|Erlotinib|Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
16256017|NCT00965731|Drug|Erlotinib|For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
16256018|NCT00965731|Drug|PF-02341066|For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
16256019|NCT00965718|Biological|Activated T lymphocyte|Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
16256020|NCT00965705|Behavioral|Therapy|Individual Therapy and Group Therapy
16256021|NCT00965666|Drug|Etanercept|All qualified subjects receive 24 weekly subcutaneous injections of Etanercept.
16256022|NCT00965653|Drug|folic acid|>/= 5 mg po weekly
16256023|NCT00965653|Drug|methotrexate|7.5 - 25 mg weekly (oral or parenteral)
16256024|NCT00965653|Drug|tocilizumab [RoActemra/Actemra]|162 mg sc weekly (QW)for 12 weeks
16256025|NCT00965653|Drug|tocilizumab [RoActemra/Actemra]|162 mg sc every other week (Q2W) for 12 weeks
16256026|NCT00965640|Drug|Botulinum Toxin - A injections|
16256027|NCT00965614|Other|MCG|Cardiac Arrhythmia,Heart Disease
16256071|NCT00965172|Other|Baking Soda|Oral rinse of baking soda solution as per standard of care five times daily beginning on day one of chemotherapy.
16256028|NCT00965601|Behavioral|Cognitive Behavioral Therapy|Subjects randomized to the Active Arm will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)
16256029|NCT00965588|Biological|UB 311|Single liquid dose by intramuscular route at weeks 0, 4, 12.
16256030|NCT00965575|Drug|Melatonin|Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime for four weeks.
16256031|NCT00965575|Drug|Placebos|Placebo. Taken 30 minutes prior to bedtime for four weeks.
16256032|NCT00965562|Drug|Fluoxetine|Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.
16256033|NCT00965562|Drug|Calcium|1200 mg of calcium to be taken for 5 menstrual cycles.
16256034|NCT00965562|Drug|Placebo|For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.
16256035|NCT00965549|Drug|INSULIN GLARGINE (HOE901)|LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
16256036|NCT00965549|Drug|Insulin aspart|NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®)
16256037|NCT00965549|Drug|Insulin Glulisine|APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
16256038|NCT00965523|Drug|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.
16256039|NCT00965510|Behavioral|care coordination|patients receive care coordination to improve their type II diabetes
16256040|NCT00965497|Drug|escitalopram|After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.
16256041|NCT00965484|Device|New Genotropin Pen|Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen
16256042|NCT00965471|Drug|cipher prescription 1|Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days
16256043|NCT00965471|Drug|cipher prescription 2|Placebo include amidon、bitter principles and diluents bases once daily for 180 days
16256044|NCT00965458|Biological|Alefacept|Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
16256045|NCT00965458|Drug|Placebo|Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
16256046|NCT00965432|Drug|STX107|Single dose of an oral suspension
16256047|NCT00965419|Drug|Edivoxetine|0.1 mg/kg/day or participant specific known stable dose, rollover participants (LNBJ [No NCT number]) and (LNBF [NCT00922636]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
16256048|NCT00965406|Drug|GIK and intensive insulin therapy|GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours. Intravenous intensive insulin therapy is simultaneously administered according to our protocol in the ED
16256049|NCT00965393|Procedure|Forearm vascular study|Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
16256050|NCT00965393|Drug|Placebo|Systemic infusion of placebo (saline)
16256051|NCT00965393|Drug|bradykinin receptor antagonist (HOE-140)|Systemic infusion of bradykinin receptor antagonist (HOE-140)
16256052|NCT00965367|Device|Acustimulation|Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
16256053|NCT00965341|Drug|Testosterone|Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
16256054|NCT00965341|Drug|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
16256055|NCT00965328|Procedure|CVVH 4 to 2 L/h|CVVH is initiated at 4L/h and is converted to 2L/h after 60 min
16256056|NCT00965328|Procedure|CVVH 2 to 4L/h|CVVH is initiated at 2L/h and is converted to 4L/h after 60 min
16256057|NCT00965315|Drug|Rosuvastatin,SFC fenofibrate|"Rosuvastatin 10 mg once daily
~Rosuvastatin 5 mg + SFC fenofibrate 160 mg"
16256058|NCT00965302|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.
16256059|NCT00965302|Behavioral|Intensive medical management|Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
16256060|NCT00965289|Drug|Rituximab|Rituximab infusion on day 1 dose: 375mg/m²
16256061|NCT00965263|Biological|Cocaine vaccine (TA-CD)|TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
16256062|NCT00965250|Drug|IMC-12|20 mg/kg intravenously once every three weeks
16256063|NCT00965237|Device|lotrafilcon B multifocal contact lens|Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
16256064|NCT00965237|Device|lotrafilcon B single vision contact lens|Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
16256065|NCT00965237|Other|Over-reader spectacles|Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
16256066|NCT00965224|Biological|dendritic cell vaccination (active specific immunotherapy)|
16256067|NCT00965211|Device|HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)|a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 1 Hz to the supplementary motor cortex and then a 2 minute recess.each subject would undergo 5 sessions a week for 4 weeks.
16256068|NCT00965185|Drug|atorvastatin|20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.
16256069|NCT00965185|Drug|Placebo|Placebo
16256160|NCT00964626|Drug|cisplatin|
16256072|NCT00965146|Device|Scorpio® CR Total Knee System|All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
16256073|NCT00965133|Other|Endurance training intervention|High intensive interval training of walking / running on treadmill for 1 1/2 - 4 minute,repeated minimum 4 times, at an intensity equalling at least 80% of maximal heart frequency. Performed 2-5 times per week for 4-8 weeks, totally 24 sessions.
16256074|NCT00965120|Procedure|Forearm vascular study|Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
16256075|NCT00965120|Drug|bradykinin receptor antagonist (HOE-140)|Systemic infusion of bradykinin receptor antagonist (HOE-140).
16256076|NCT00965120|Drug|Placebo (saline)|Systemic infusion of placebo (saline).
16256077|NCT00965107|Drug|Thiopental|Thiopental given as a bolus dose of 2,5 mg/kg.
16256078|NCT00965107|Drug|Propofol|Propofol given as a bolus dose of 1 mg/kg.
16256079|NCT00965094|Drug|Everolimus|One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL)
16256080|NCT00965094|Drug|Tacrolimus (FK506)|Capsules 0.5 mg, 1 mg. Dosing according to blood level.
16256081|NCT00965094|Drug|Basiliximab|One vial containing 20 mg lyophilisate. 2 x 20 mg [day 0 (2 hrs prior to Tx) and day 4 post Tx] to be applied as 10 sec. bolus injection, i.v.
16256082|NCT00965094|Drug|Enteric Coated Mycophenolate Sodium (EC-MPS)|One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day)
16256083|NCT00965094|Drug|Corticosteroids|Used according to Israeli standards. A minimum dose of 5mg [prednisone, or equivalent, was used throughout the study period.
16256084|NCT00965081|Drug|Duloxetine|30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
16256085|NCT00965081|Drug|Placebo|QD po at the same time each day for 12 weeks
16256086|NCT00965068|Other|Cholesterol|
16256087|NCT00965055|Drug|Ezetimibe|10 mg
16256088|NCT00965055|Drug|Atorvastatin|"Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy.
~Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients
~Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit.
~Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test
~Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation.
~Visit 6: Final cholesterol panel and conclusion of study period"
16256089|NCT00965042|Drug|Ceftobiprole|ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days
16256090|NCT00965016|Procedure|hypothermia|Core temperature --> 34.9℃ within 30 min --> 33.5℃ within 120min --> 33℃for 24 H Decrease temperature in 0.9℃/hour
16256091|NCT00965003|Procedure|MRI scan|Standard of Care
16256092|NCT00964990|Drug|JNJ-42160443|Type=exact number, unit=mg, number= 1, 3, or 10, form=solution for injection, route=Subcutaneous use. One injection of 1, 3, or 10 mg of JNJ-42160443 every 28 days for up to 52 wks and then every 4, 8, or 12 weeks for up to an additional 52 weeks
16256093|NCT00964990|Drug|Placebo|Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks
16256094|NCT00964977|Radiation|Radiation therapy|Patients receive radiation within 6 weeks after surgery. At primary tumour site and involved lymph node level a total dose of 59.4 Gy in 33 fractions within 45 days is scheduled according to the rules of ICRU report 50.
16256095|NCT00964964|Drug|insulin degludec|Insulin degludec injected s.c. (under the skin) three times weekly
16256096|NCT00964964|Drug|insulin degludec|Insulin degludec injected s.c. (under the skin) once daily for one week
16256097|NCT00964964|Drug|placebo|Placebo injected s.c. (under the skin) four times weekly
16256098|NCT00964951|Biological|AS03|AS03 adjuvant administered with 3.75, 7.5, or 15 mcg Inactivated H1N1 Vaccine.
16256099|NCT00964951|Biological|Inactivated H1N1 Vaccine|Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly as 7.5 or 15 micrograms per dose. All doses of vaccine with or without adjuvant will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm.
16256100|NCT00964938|Device|Quadripolar LV lead (pacing configurations)|Quadripolar LV lead will be used to deliver a combination of pacing configurations
16256101|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 0.025 mg, single dose, one dose
16256102|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 0.1 mg, single dose, one dose
16256103|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 0.25 mg, single dose, one dose
16256104|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 0.5 mg, single dose, one dose
16256105|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 1 mg, single dose, one dose
16256106|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 2 mg, single dose, one dose
16256107|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 3 mg, single dose, one dose
16256108|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 5 mg, single dose, one dose
16256109|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 8 mg, single dose, one dose
16256110|NCT00964912|Drug|Placebo|Oral Solution, Oral, 0 mg, single dose, one dose
16256111|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 3 mg, single dose, one dose
16256112|NCT00964912|Drug|BMS-820836|Oral Solution, Oral, 0.5 mg, single dose, one dose
16256113|NCT00964886|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
16256114|NCT00964886|Drug|desipramine hydrochloride|desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
16256115|NCT00964886|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
16256116|NCT00964886|Drug|benztropine mesylate 0.125 mg daily|benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
16256117|NCT00964886|Drug|desipramine hydrochloride|desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
16256118|NCT00964873|Drug|STA-9090 (ganetespib)|Chemotherapy agent
16256119|NCT00964860|Device|Glide dental floss|Glide waxed dental floss
16256120|NCT00964847|Behavioral|Yoga exercise program|Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study.
16256121|NCT00964847|Behavioral|Blood pressure education/walking program|The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day.
16256122|NCT00964834|Drug|Doxycycline and Valortim|Days 1-5 100mg IV Doxycycline BID over 60 minutes. Day 6 20mg/kg Valortim IV over 60 minutes.
16256123|NCT00964834|Drug|Placebo Antibiotic and Valortim|Days 1-5 20mg/kg IV Normal Saline BID over 60 minutes. Day 6 20mg/kg IV Valortim over 60 minutes.
16256124|NCT00964834|Drug|Placebo Antibiotic and Placebo Valortim|Days 1-5 200mL IV Normal Saline for Placebo Antibiotic BID over 60 minutes. Day 6 20mg/kg IV Normal Saline for Placebo Valortim over 60 minutes.
16256125|NCT00964821|Biological|trivalent influenza vaccine|Patients or normal volunteers who will be vaccinated against the flu.
16256126|NCT00964821|Other|Immunoenzyme technique|This test will determine the level of antibodies in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.
16256127|NCT00964821|Other|Laboratory biomarker analysis|This test will count the number of T cells (the cells that kill the flu virus) in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.
16256128|NCT00964808|Drug|Buprenorphine|Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
16256129|NCT00964808|Drug|Oxycodone|Start: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg * 2 pr. day until time to discharge from the Hospital or latest at day 12.
16256130|NCT00964795|Drug|Intravitreal Aflibercept Injection 2mg|
16256131|NCT00964782|Drug|Sildenafil|oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.
16256132|NCT00964782|Drug|Placebo|Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.
16256133|NCT00964782|Drug|Sildenafil 2|oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).
16256134|NCT00964782|Drug|Placebo 2|Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).
16256135|NCT00964769|Biological|pneumococcal polysaccharide vaccine|single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)
16256136|NCT00964756|Genetic|Ad5.SSTR/TK.RGD|Group 1 Day 1-3 IP 1 x 10 9th vp/d Group 2 Day 1-3 IP 5 x 10 10th vp/d Group 3 Day 1-3 IP 1 x 10 12th vp/d
16256137|NCT00964756|Drug|Ganciclovir (GCV)|GVC Day 5-18 IV 5 mg/kg BID all groups
16256138|NCT00964743|Drug|DepoCyt|Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses.
16256139|NCT00964743|Drug|Sorafenib|Patients received oral sorafenib at 400 mg twice a day
16256140|NCT00964730|Drug|Talampanel|titrated to 50mg three times a day over 9 days and a single dose administered on Day 10
16256141|NCT00964730|Drug|Moxifloxacin|Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10
16256142|NCT00964730|Drug|Placebo|administered three times a day over 9 days and a single dose administered on Day 10
16256143|NCT00964717|Procedure|real chiropractic|real chiropractic manipulation
16256144|NCT00964717|Procedure|Sham Chiropractic|Placebo stimulation using 'activator' thumper
16256145|NCT00964704|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
16256146|NCT00964704|Drug|capecitabine [Xeloda]|added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
16256147|NCT00964704|Drug|docetaxel|background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
16256148|NCT00964704|Drug|trastuzumab [Herceptin]|8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks
16256149|NCT00964691|Drug|Sulphadoxine-pyrimethamine|3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose)
16256150|NCT00964691|Drug|Chloroquine prophylaxis|300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.
16256151|NCT00964678|Drug|Carvedilol|twice daily oral treatment in escalating dose
16256152|NCT00964665|Drug|albinterferon alfa-2b|
16256153|NCT00964665|Drug|albinterferon alfa-2b|
16256154|NCT00964665|Drug|albinterferon alfa-2b|
16256155|NCT00964665|Drug|albinterferon alfa-2b|
16256156|NCT00964665|Drug|Pegasys®|
16256157|NCT00964652|Other|Treadmill walking training with additional body load|"The training program was divided into three phases (A1-B-A2):
~treadmill training with additional body load (A1), control condition (conventional physical therapy) (B). and treadmill training with additional body load again (A2). Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle."
16256158|NCT00964639|Drug|Ropivacaine|During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day
16256161|NCT00964626|Drug|paclitaxel|
16256162|NCT00964600|Procedure|TAP blockade|15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm
16256163|NCT00964587|Behavioral|Education + Problem-Solving Training Self-Study|"Education + Problem-Solving Training Self-Study
~One session of Literacy-Adapted Diabetes and CVD Risk Education
~Instructions and a schedule for use of the Literacy-Adapted Problem-Solving Workbook for self-study will be given to each participant."
16256164|NCT00964587|Behavioral|Education + Group Problem-Solving Training|"Education + Group Problem-Solving Training
~One session of the Literacy-Adapted Diabetes and CVD Risk Education
~Group problem-solving training eight, 90-minute sessions"
16256165|NCT00964587|Behavioral|Education + Individual Problem-Solving Training|"Education + Individual Problem-Solving Training
~One session of the Literacy-Adapted Diabetes and CVD Risk Education
~Individual problem-solving training (eight, 60-minute sessions)"
16256166|NCT00964587|Behavioral|Usual Care|"Packet of print patient education materials about CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA)given at baseline following randomization to Arm 1
~Scripted set of instructions will be given along with a verbal description of the materials and the content provided."
16256167|NCT00964574|Drug|INSULIN GLULISINE (HMR1964)|"Pharmaceutical form:
~APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet
~Route of administration:
~3-4 subcutaneous injections per day"
16256168|NCT00964574|Drug|INSULIN GLARGINE|"Pharmaceutical form:
~LANTUS 100U/ml solution for injection in cartridge
~Route of administration:
~Once daily subcutaneous injection in the evening"
16256169|NCT00964561|Drug|Ciprofloxacin and Valortim|Days 1-3 400mg IV Ciprofloxacin BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.
16256170|NCT00964561|Drug|Placebo Antibiotic and Valortim|Days 1-3 20mg/kg IV Normal Saline BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.
16256171|NCT00964561|Other|Placebo Antibiotic and Placebo Valortim|Days 1-3 200mL IV Normal Saline for Placebo Antibiotic over 60 minutes. Day 4 200mL IV Normal Saline for Placebo Valortim over 60 minutes.
16256172|NCT00964548|Drug|Dantrolene|1.25 mg/kg IV once over 60 min
16256173|NCT00964548|Drug|Dantrolene|2.5 mg/kg IV once over 60 min
16256174|NCT00964535|Drug|budesonide and formoterol 200/6 microg|2 inhalations as a single dose
16256175|NCT00964535|Drug|budesonide and formoterol 200/6 microg|2 inhalations as a single dose
16256176|NCT00964535|Drug|budesonide and formoterol 200/6 microg|2 inhalations as a single dose with the concurrent charcoal blockage
16256177|NCT00964535|Drug|budesonide and formoterol 200/6 microg|2 inhalations as a single dose with the concurrent charcoal blockage
16256178|NCT00964522|Other|Nurse education and care program|Random allocation of the patients in two arms according to the nursing cares. The arm A is the one of standard education and care. They consist of receiving programmed oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle of treatment. Also, the patients will be able to ask for information to the nurses when they need it. Arm B is the one of experimental education and care. They consist of receiving oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle. In addition, the patients assigned to arm B will receive programmed education and care about the chemotherapy by a Oncology nurse before the beginning of the treatment and in each cycle, in a specific nurse consultation.
16256179|NCT00964496|Drug|Thalidomide|Patients were randomly assigned to receive a four-month course of 25 mg of thalidomide (Pharmaceutical Co., Ltd. of Chang-zhou, China). Medications were taken orally four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
16256180|NCT00964496|Drug|Iron|Patients were randomly assigned to receive a four-month course of 100 mg of iron (Pharmaceutical Co., Ltd. of Nanjing, China). Medications were taken orally four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
16256181|NCT00964483|Behavioral|DASH diet|The intervention will consist of a 12-week pilot trial in which participants will be given intervention materials tailored to their community, focusing on DASH. Intervention content will be designed to provide participants with the knowledge and skills to adopt the DASH eating pattern, specifically to increase fruit, vegetable, and low-fat dairy intake, and to decrease saturated fats and sodium. They will follow this diet for 12 weeks.
16256182|NCT00964483|Behavioral|Delayed Intervention|"The participants will receive a guide written by NHLBI entitled, Your Guide to Lowering Blood Pressure."
16256183|NCT00964470|Device|AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings|Dressing, donor site dressings
16256184|NCT00964457|Drug|cetuximab|cetuximab 500mg per meter square every second week
16256185|NCT00964444|Device|Peisner device|The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.
16256186|NCT00964431|Drug|Celecoxib 400 mg|Capsules 2 x 200 mg Single-Dose
16256187|NCT00964431|Drug|Placebo|Capsules 2 Single-Dose
16256188|NCT00964431|Drug|Indomethacin Test (lower dose)|20-mg single dose
16256189|NCT00964431|Drug|Indomethacin Test (upper dose)|40-mg single dose
16256190|NCT00964418|Drug|insulin degludec|0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days
16256191|NCT00964418|Drug|insulin glargine|0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days
16256192|NCT00964405|Drug|GSK233705|Inhaled Long acting muscarinic receptor antagonist
16256193|NCT00964405|Drug|Placebo|Matching placebo
16256194|NCT00964392|Procedure|Atrial fibrillation ablation|Radiofrequency ablation
16256195|NCT00964379|Procedure|intraperitoneal or extraperitoneal colostomy|creation of colostomy
16256196|NCT00964366|Drug|clindamycin and benzoyl peroxide|Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide
16256197|NCT00964366|Drug|Dapsone gel|Twice-daily applications of dapsone gel
16256198|NCT00964353|Drug|Warfarin|Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
16256199|NCT00964340|Drug|Placebo|For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product. The ratio of active to placebo capsules will vary according to the subject's dosing level.
16256200|NCT00964340|Drug|SRT2104|SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of the SRT2104 powder into a size 00 opaque capsule, which is then stored in dosing bottles.
16256202|NCT00964314|Other|music|"Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
~Experimental Group two: Listening western music based on conventional therapy in China.
~Control Group: no music therapy will be done."
16256203|NCT00964301|Other|Telemedicine Education|"Student Asthma Education. Each student will engage in 6 age-appropriate sessions on various aspects of asthma health.
~Caregiver Asthma Education. The primary caregiver will engage in 2 asthma education sessions.
~School Nurse Asthma Education. School nurses will participate in 2 sessions.
~Primary Care Provider (PCP) Communication. The PCP of the intervention group participant will be notified of his/her patient's baseline asthma assessment. They will receive updates summarizing each telemedicine intervention."
16256204|NCT00964301|Other|Usual care|Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.
16256205|NCT00964288|Drug|GSK1014802 low dose|oral tablet
16256206|NCT00964288|Drug|Lidocaine|positive control
16256207|NCT00964288|Drug|GSK1014802 high dose|oral tablet
16256208|NCT00964288|Drug|Placebo|To match GSK drug and positive control
16256209|NCT00964275|Procedure|diagnostic procedure|Standard diagnostic procedures followed
16256210|NCT00964275|Radiation|fludeoxyglucose F 18|PET with flueoxyglucose F 18
16256211|NCT00964262|Drug|SR Exenatide (PT302)|0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
16256212|NCT00964262|Drug|Placebo|Plcacebo of each doasage, single subcutanoeus injection
16256213|NCT00964249|Drug|GW642444|Long acting Beta 2 agonist
16256214|NCT00964249|Drug|Placebo|Matching placebo
16256215|NCT00964236|Drug|Sapropterin|Sapropterin (Kuvan) 20mg/kg/day taken once daily or as otherwise prescribed by physician as standard care.
16256216|NCT00964223|Drug|Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)|Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
16256217|NCT00964223|Drug|benzoyl peroxide and adapalene gel (EPIDUO™ Gel)|Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
16256218|NCT00964210|Drug|Licensed quadrivalent HPV vaccine, Gardasil|The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.
16256219|NCT00964197|Device|FemmeJock|The participant will be fitted with the girdle. The participant will use the girdle for the next 3 months. The girdle is only to be worn during the daytime during times of physical activity. The length of time you choose to wear it during the day is the patients choice. In two weeks the participant will be asked to fill out a 5 question survey in a follow up visit. The participant will be asked to return 3 months after wearing the FemmeJock girdle and to fill out a 5 question survey, as well as to complete a 20 question survey.
16256220|NCT00964184|Drug|Metformin|
16256221|NCT00964184|Behavioral|Lifestyle modification|
16256222|NCT00964171|Drug|efavirenz|
16256223|NCT00964171|Procedure|quality-of-life assessment|
16256224|NCT00964158|Biological|Pandemic influenza vaccine GSK2340272A|Two primary intramuscular (IM) injections and a booster IM injection
16256225|NCT00964132|Drug|NRX194204|Once Daily, Oral
16256226|NCT00964106|Drug|Caffeine|Caffeine dosed at 100 mg as probe for CYP1A2 pathway
16256227|NCT00964106|Drug|Rosiglitazone|Dosed at 4 mg as probe for CYP2C8 pathway
16256228|NCT00964106|Drug|Flurbiprofen|Dosed at 40 mg, probe for CYP2C9 pathway
16256229|NCT00964106|Drug|Omeprazole|Dosed at 20 mg, probe for CYP2C19 pathway
16256230|NCT00964106|Drug|Dextromethorphan|Dosed at 30 mg, probe for CYP2D6 pathway
16256231|NCT00964106|Drug|Midazolam|Dosed at 3 mg for Part 1, Part 2 cohorts B and C and 1 mg for Part 2 Cohort A, probe drug for CYP3A4/5 pathway
16256232|NCT00964106|Drug|Rosuvastatin|Dosed at 10 mg, probe drug for OATP1B1 pathway
16256233|NCT00964106|Drug|Ketoconazole|Dosed at 400 mg once-daily Day 1 through Day 9, inhibitor of CYP3A4
16256234|NCT00964106|Drug|Fluconazole|Dosed at 400 mg x 1 dose on day 1, 200 mg once daily on days 2 through 9, inhibitor of CYP2C9 pathway
16256235|NCT00964106|Drug|Rifampin|Dosed at 600 mg x 1 dose on Day 1 and Day 8, inhibitor of OATP1B1 pathway
16256236|NCT00964106|Drug|Rosiglitazone|Dosed at 15 mg, probe drug for CYP2C8 pathway
16256237|NCT00964093|Device|Silver Alginate|(Algidex ™)
16256238|NCT00964080|Drug|MBP-426/Leucovorin/5-FU|MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered at a dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2.
16256239|NCT00964067|Other|Exercise training|Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.
16256240|NCT00964054|Other|Public Health Dose of Exercise (PHD)|17.5 kcal per kilogram per week
16256241|NCT00964054|Other|Low Dose Exercise (LD)|7.0 kcal per kilogram per week
16256242|NCT00964041|Drug|D-cycloserine|50 mg by mouth weekly, one hour before assessments, for eight weeks.
16256243|NCT00964041|Drug|Placebo|Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.
16256244|NCT00964028|Biological|Infanrix™-IPV/Hib|Intramuscular, three doses
16256245|NCT00964015|Drug|6% Hydroxyethyl Starch 130/0.4|
16256246|NCT00964015|Drug|0.9% Normal Saline|
16256247|NCT00964002|Drug|efavirenz|
16256248|NCT00963989|Device|Penumbra System|The Penumbra System is used to revascularize clotted cerebral blood vessels.
16256249|NCT00963976|Drug|labetalol/hydralazine/enalapril|Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
16256250|NCT00963963|Behavioral|Healthy Futures parent education|Multi-year audio CD parent education
16256251|NCT00963950|Procedure|transvaginal cholecystectomy|Transvaginal approach to gallbladder removal.
16256252|NCT00963950|Procedure|laparoscopic cholecystectomy|laparoscopic cholecystectomy
16256253|NCT00963937|Drug|Sumatriptan 25 mg|One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
16256254|NCT00963937|Drug|Sumatriptan 50 mg|Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
16256255|NCT00963937|Drug|Placebo|Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
16256256|NCT00963924|Drug|D-cycloserine|50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
16256257|NCT00963924|Drug|Placebo|Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
16256258|NCT00963924|Behavioral|Cognitive Remediation|40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
16256259|NCT00963911|Other|Geriatric screening tests|"The G-8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14 and the time taken to complete the test was recorded.
~VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment."
16256260|NCT00963911|Other|Multidimensional geriatric assessment|Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study).
16256261|NCT00963898|Device|Target controlled infusion(TCI), Bispectral index(BIS)|Using TCI and BIS or not
16256262|NCT00963885|Drug|Copegus|1000 or 1200mg po daily for 24 or 48 weeks
16256263|NCT00963885|Drug|Pegasys|180micrograms sc weekly for 24 or 48 weeks
16256264|NCT00963885|Drug|Placebo|po for 12 weeks
16256265|NCT00963885|Drug|Placebo|po for 24 weeks
16256266|NCT00963885|Drug|RO5190591 (Danoprevir)|300mg po q8h for 12 weeks
16256267|NCT00963885|Drug|RO5190591 (Danoprevir)|600mg po q12h for 12 weeks
16256268|NCT00963885|Drug|RO5190591 (Danoprevir)|900mg po q12h for 12 weeks
16256269|NCT00963885|Drug|RO5190591 (Danoprevir)|300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
16256270|NCT00963872|Drug|cyclophosphamide|50 mg/kg intravenously (IV) over 2 hours on Day -6.
16256271|NCT00963872|Drug|fludarabine phosphate|40 mg/m^2 over 1 hour on Days -6 through -2.
16256272|NCT00963872|Radiation|Total body irradiation|200 cGy on Day -1
16256273|NCT00963872|Biological|Umbilical cord blood unit with C3a fragment|On Day 0, the C3a primed UCB unit will be infused intravenously SECOND, within 30 minutes of the completion of the infusion of the unmanipulated UCB unit, through a central line without in-line filtration in a manner identical to the unmanipulated UCB unit.
16256274|NCT00963872|Biological|Unmanipulated UCB Unit|On Day 0, the unmanipulated UCB unit will be infused FIRST through a central line without in-line filtration per institutional guidelines.
16256275|NCT00963859|Procedure|Robotic-assisted laparoscopic surgery|During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.
16256276|NCT00963846|Drug|placebo|matching pill placebo
16256277|NCT00963846|Drug|huperzine 0.2 mg BID|huperzine rising doses up to 0.2 mg BID
16256278|NCT00963846|Drug|huperzine 0.4 mg BID|huperzine rising doses up to 0.4 mg BID
16256279|NCT00963846|Drug|huperzine 0.8 mg BID|huperzine rising doses up to 0.8 mg BID
16256280|NCT00963833|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Patients under daily life treatment receiving Betaferon according to local product information.
16256281|NCT00963820|Drug|Ixazomib citrate|Ixazomib citrate capsules
16256282|NCT00963807|Drug|Cisplatin|Given IV
16256283|NCT00963807|Procedure|CT|Undergo FDG PET/CT, FLT PET/CT and thoracic CT
16256284|NCT00963807|Drug|Docetaxel|Given IV
16256285|NCT00963807|Drug|FDG|Undergo FDG PET/CT
16256286|NCT00963807|Drug|FLT|Undergo FLT PET/CT
16256287|NCT00963807|Procedure|PET/CT|Undergo FDG PET/CT and FLT PET/CT
16256288|NCT00963807|Procedure|Surgery|Undergo surgery
16256289|NCT00963794|Other|Electromagnetic measurement|RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
16256330|NCT00963508|Drug|Permethrin 1% rinse (Nix Crème)|Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.
16256331|NCT00963495|Drug|Clioquinol|Patients will take Clioquniol at escalating doses depending on when they enter into the trial.
16256376|NCT00963092|Genetic|microarray analysis|
16256290|NCT00963781|Device|Medtronic Endeavor Stent|The study population was to consist of 900 consecutive, eligible patients with ischemic heart disease scheduled to undergo elective percutaneous coronary revascularization and amenable to treatment with an Endeavor drug-eluting stent with reference vessel diameter between 2.5 and 4.0 mm. Patients will be assigned to 6 month duration of post-procedure thienopyridine treatment with indefinite aspirin (minimum 81 mg daily) according to protocol. Recruitment was terminated early due to difficulty recruiting patients and difficulty achieving patient compliance with the six month anti-platelet protocol.
16256291|NCT00963781|Drug|Reduced duration (6 months) DAPT|
16256292|NCT00963768|Drug|JNJ 28431754|A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
16256293|NCT00963768|Drug|Placebo|A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
16256294|NCT00963742|Device|Lenstec Softec HD IOL implantation|surgical removal of cataract and implantation of Softec HD PCIOL
16256295|NCT00963729|Drug|cyclophosphamide|Given IV
16256296|NCT00963729|Drug|docetaxel|Given IV
16256297|NCT00963729|Drug|epirubicin hydrochloride|Given IV
16256298|NCT00963729|Drug|fluorouracil|Given IV
16256299|NCT00963729|Drug|letrozole|Given orally
16256300|NCT00963716|Device|Hot biopsy forceps|Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
16256301|NCT00963716|Device|Cold biopsy forceps|Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
16256302|NCT00963703|Drug|Rituximab|Rituximab 1000 mg Intravenously day 1 and day 15
16256303|NCT00963690|Device|CloSys Hemostatic Device (HD)|Deploy CloSys HD to achieve hemostasis
16256304|NCT00963690|Procedure|Standard compression|Use standard compression to achieve hemostasis
16256305|NCT00963677|Procedure|Nasotracheal Intubation through seeing optical stylet (SOS)|Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani
16256306|NCT00963664|Drug|lovastatin|lovastatin tablets, oral administration, daily dose 1.5 mg/kg, divided into three or four essentially equal doses with meals
16256307|NCT00963664|Drug|interferon alfa-2b|interferon alfa-2b for subcutaneous injection, each injection 100,000 international units per kg body mass, three injections weekly
16256308|NCT00963651|Device|Chest tomosynthesis and X-ray|VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)
16256309|NCT00963638|Dietary Supplement|MagTabSR|MagTabSR/placebo 168 mgs BID for 6 six weeks
16256310|NCT00963638|Dietary Supplement|Placebo|MagTabSR/placebo 168 mgs BID for 6 six weeks
16256311|NCT00963625|Procedure|Embryo cryopreservation|Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
16256312|NCT00963625|Procedure|Fresh blastocyst transfer|Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
16256313|NCT00963612|Procedure|BOLD MRI test|Additional MR pulse sequence performed on BOLD MRI is expected to increase the regular scan time by an additional 5-10 minutes. No intravenous contrast is required for BOLD acquisition.
16256314|NCT00963599|Drug|Comparator: montelukast/loratadine|montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
16256315|NCT00963599|Drug|Comparator: montelukast|montelukast 10 mg tablet taken once daily at bed time for 2 weeks
16256316|NCT00963599|Drug|Comparator: loratadine|loratadine 10 mg tablet taken once daily at bed time for 2 weeks
16256317|NCT00963599|Drug|Comparator: placebo|placebo tablet taken once daily at bed time for 2 weeks
16256318|NCT00963573|Drug|Loratadine|loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
16256319|NCT00963573|Drug|Betamethasone|loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
16256320|NCT00963560|Device|ReSTOR +3|Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
16256321|NCT00963560|Device|Crystalens HD|Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
16256322|NCT00963560|Device|Crystalens AO|Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
16256323|NCT00963547|Drug|MK-2206|[Part 1]: MK-2206 tablets will be given starting at a dose of 45 mg QOD and escalated to 60 mg QOD if tolerated, OR starting at a dose of 135 mg QW and escalated to 200 mg QW if tolerated. Dose reduction to 30mg QOD or 90 mg QW may be permitted. The dose of MK2206 will be increased or decreased as required to find the maximum tolerated dose (MTD) of MK2206 for both the QOD and QW dosing schedules in combination with trastuzumab. [Part 2] The Part 2 dosing level and schedule of MK2206 will be chosen from the MTD of either the QOD or QW dosing schedules depending on the toxicity profile and preliminary efficacy.
16256324|NCT00963547|Biological|Trastuzumab|Trastuzumab will be administered as a 90-minute IV infusion at a loading dose of 8 mg/kg followed by 6 mg/kg q3wk.
16256325|NCT00963547|Drug|Lapatinib|Lapatinib tablets will be administered orally QD in doses of 500 mg, 750 mg, or 1000 mg.
16256326|NCT00963534|Drug|lenalidomide, bendamustine, rituximab|"Phase I: Maximally tolerable dose of lenalidomide will be determined, starting with 5 mg per day, and up to maximally 25 mg per day. This treatment is given in combination with bendamustine and rituximab.
~Phase II: Determination of progression free survival with treatment with lenalidomide (dosing determined in phase I) in combination with bendamustine and rituximab."
16256327|NCT00963534|Drug|lenalidomide, bendamustine, rituximab|lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6
16256328|NCT00963521|Biological|therapeutic autologous dendritic cells|
16256329|NCT00963508|Drug|Malathion gel 0.5%|Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
16256332|NCT00963482|Behavioral|Cognitive-behavioural smoking cessation program|It's a cognitive-behavioural intervention for smoking cessation. Originally based on a 6 week program designed for outpatients (Batra & Buchkremer 2004). This program was then specifically tailored for inpatient use with additional information addressing the interaction of smoking and drinking and its consequences.
16256333|NCT00963482|Behavioral|Autogenic training|Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
16256334|NCT00963469|Drug|montelukast sodium|montelukast 10 mg tablet orally once daily in the morning for 4 weeks
16256335|NCT00963469|Drug|Comparator: loratadine|loratadine 10 mg tablet orally once daily in the morning for 4 weeks
16256336|NCT00963469|Drug|Comparator: placebo|placebo tablet orally once daily in the morning for 4 weeks
16256337|NCT00963443|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|2 Sachets of 500 mg Aspirin Complex.
16256338|NCT00963443|Drug|Pseudoephedrine|2 Sachets of 30 mg Pseudoephedrine
16256339|NCT00963443|Drug|Placebo|Matching Placebo
16256340|NCT00963430|Biological|Inactivated H1N1 Vaccine|Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly (IM) as 15 or 30 mcg dose. The 15 mcg dose will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as a single 1.0 mL injection in the deltoid muscle.
16256341|NCT00963417|Other|laboratory biomarker analysis|Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
16256342|NCT00963417|Procedure|dual x-ray absorptiometry|Serial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA).
16256343|NCT00963404|Radiation|Radiation boost|Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.
16256344|NCT00963391|Other|ABHS use|"Centers assigned to the intervention group were provided with ABHS dispensers with a gel solution with ethyl alcohol at 62% as active ingredient (Purell®, GOJO Industries, Dayton, Ohio). A total of 85 dispensers were installed, one dispenser was installed in each center of size less than 14 children, and one per classroom plus an additional one for common areas in centers with more than 28 children. Proper safety measures were followed.
~Standardized ABHS training workshops for staff and children in centers allocated to the intervention were carried out simultaneously with dispenser installation. Thirty minute refresher sessions about ABHS technique were provided to staff and children on a monthly basis, for a total of 8 sessions per center."
16256345|NCT00963365|Drug|AZD6765|Single oral dose and single IV infusion of AZD6765
16256346|NCT00963365|Drug|AZD6765|Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.
16256347|NCT00963339|Device|Foresee Home|Home Monitoring
16256348|NCT00963326|Other|laboratory biomarker analysis|
16256349|NCT00963313|Drug|Adalimumab (HUMIRA®)|Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.
16256350|NCT00963300|Procedure|blood-oxygen-level-dependent functional magnetic resonance imaging|
16256351|NCT00963300|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16256352|NCT00963300|Procedure|magnetic resonance spectroscopic imaging|
16256353|NCT00963300|Procedure|tissue-oxygen-level-dependent functional magnetic resonance imaging|
16256354|NCT00963287|Drug|bascial prescription plus or minus herbs depend on symptoms|Decoction ,two times a day
16256355|NCT00963274|Drug|Bortezomib|Starting dose: 1.3 mg/sq m
16256356|NCT00963274|Drug|Romidepsin|Starting dose: 8 mg/sq m
16256357|NCT00963261|Behavioral|psycho-oncological intervention|stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)
16256358|NCT00963235|Biological|13-valent pneumococcal conjugate vaccine|Three doses of 13vPnC given 6 months apart.
16256359|NCT00963235|Procedure|Blood draw|Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.
16256360|NCT00963222|Drug|vitamin A|1 cap vitamin A 25000 IU/day for 3 month
16256361|NCT00963222|Drug|placebo|1 cap placebo/day for 3 month
16256362|NCT00963209|Drug|tamoxifen citrate|
16256363|NCT00963209|Other|laboratory biomarker analysis|
16256364|NCT00963209|Other|pharmacological study|
16256365|NCT00963196|Dietary Supplement|Omega-3 fatty acid|2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks
16256366|NCT00963196|Drug|Bovine gelatin capsules|Bovine gelatin capsules that appear similar to active drug acting as placebo.
16256367|NCT00963183|Drug|AZD5423|Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
16256368|NCT00963183|Drug|Placebo|Solution for nebulisation, inhaled. Each subject will receive a single-dose.
16256369|NCT00963157|Drug|AS03|AS03 adjuvant administered with 3.75, 7.5, or 15 mcg inactivated H1N1 vaccine.
16256370|NCT00963157|Biological|Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A|Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly as 7.5 or 15 micrograms per dose. All doses of the vaccine with or without adjuvant will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm.
16256371|NCT00963131|Drug|antioxidants tablets|vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
16256372|NCT00963118|Dietary Supplement|plant based nutrition bar|Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
16256373|NCT00963105|Drug|lenalidomide|"Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
~Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
~Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
~Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity"
16256374|NCT00963092|Genetic|DNA analysis|
16256375|NCT00963092|Genetic|RNA analysis|
16256377|NCT00963092|Genetic|protein analysis|
16256378|NCT00963092|Other|cytology specimen collection procedure|
16256379|NCT00963092|Other|laboratory biomarker analysis|
16256380|NCT00963092|Other|questionnaire administration|
16256381|NCT00963079|Procedure|Embryo cryopreservation|Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
16256382|NCT00963079|Procedure|Fresh blastocyst transfer|Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
16256383|NCT00963066|Device|PSV - pressure suppot ventilation|Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.
16256384|NCT00963066|Device|NAVA - Neurally Adjusted Ventilatory Assist|Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.
16256385|NCT00963066|Device|NAVA - EMG|Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).
16256386|NCT00963053|Drug|VA111913 TS and placebo|VA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design
16256387|NCT00963040|Drug|Syntocinon (Oxytocin)|4 actuations in each nostril for a total dose of 32 IU
16256388|NCT00963040|Drug|Sterile water|4 actuations in each nostril
16256389|NCT00963027|Drug|Treprostinil diethanolamine|Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth immediately following breakfast before and after repeated daily dosing with esomeprazole.
16256390|NCT00963027|Drug|Esomeprazole|Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.
16256391|NCT00963001|Drug|Treprostinil diethanolamine|Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.
16256392|NCT00963001|Other|Standardized meals|Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.
16256393|NCT00962988|Drug|Cost-Free Pharmacotherapy Group|"Participants assigned to the cost-free pharmacotherapy group will be provided with a 12-week supply of NRT, or a 12-week supply of bupropion or varenicline.
~Patients smoking 10 cigarettes or less will be prescribed 7mg/24hours for 12 weeks. Those who smoke 11- 20 cigarettes per day will be prescribed 14 mg/24 hours for 8 weeks and then nicotine patch 7mg for 4 weeks. Those smoking ≥ 20 cigarettes per day will be prescribed 21 mg/daily for 6 weeks and then nicotine patch 14mg/daily for 4 weeks and then nicotine patch 7 mg/daily for 2 weeks.
~For patients who are prescribed varenicline, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 0.5mg once/day; Days 4-7: 0.5 mg BID; Day 8-12 weeks 1.0 mg twice daily.
~For patients who are prescribed bupropion, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 150 mg daily (in the morning); Day 4-30: 150 mg BID for 3 months."
16256394|NCT00962988|Other|Prescription Only Group|Participants assigned to the prescription only usual care group will be asked to have their prescription for smoking cessation pharmacotherapy filled at their own cost at their local community pharmacy
16256395|NCT00962975|Drug|peginterferon alfa-2a [Pegasys]|dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks
16256396|NCT00962962|Behavioral|Aerobic Exercise|Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week
16256397|NCT00962962|Behavioral|Aerobic Exercise|Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week
16256398|NCT00962962|Behavioral|Aerobic Exercise|Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week
16256399|NCT00962962|Behavioral|Exercise and Diet|"Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
~Diet - The Clinical Lifestyle Intervention sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight."
16256400|NCT00962949|Drug|Angiotensin II|Angiotensin II infusion for 1 hour
16256401|NCT00962936|Drug|CT-011|CT-011
16256402|NCT00962923|Biological|Allogeneic Mesenchymal Stem Cells (AlloMSC)|Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
16256403|NCT00962910|Other|PFF evidence based pathway|A care pathway, as complex intervention, will be implemented.
16256404|NCT00962897|Procedure|Femoral-popliteal bypass|Surgical bypass of blockage in the thigh
16256405|NCT00962897|Procedure|Stent-graft placement|Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.
16256406|NCT00962884|Device|Inspiratory Threshold Device (Res-Q-Gard ITD)|Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
16256407|NCT00962884|Device|Sham Inspiratory Threshold Device|Breathing through device similar to active device but with the one-way threshold valve removed.
16256408|NCT00962871|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc/week for 2 weeks
16256409|NCT00962871|Drug|tenofovir|300mg po daily for 2 weeks
16256447|NCT00962507|Drug|everolimus|Beginning with 5 mg every other day Monday, Wednesday or Friday for a 28 day cycle. Dose escalation will be determined by the toxicities associated with treatment.
16256410|NCT00962845|Drug|hydroxychloroquine|200 mg twice daily in the first ten patients. If the first ten patients tolerate this dosage schedule (200 mg bid) without significant side effects (Grade 3 or greater gastrointestinal upset, skin toxicity, myopathy or any visual disturbances whatsoever), the second ten patients will be enrolled at a dose of 400 mg bid
16256411|NCT00962832|Drug|Placebo|Placebo was supplied as a sterile liquid solution.
16256412|NCT00962832|Drug|Rontalizumab|Rontalizumab was supplied as a sterile liquid solution.
16256413|NCT00962819|Biological|MMR vaccine|People with no antibodies to either mumps, measles and rubella will be offered the MMR vaccine (they may choose to or choose not to receive the MMR vaccine)
16256414|NCT00962806|Behavioral|Exercise|8 weeks of intensive exercise, 60-90 minutes 3 days each week
16256415|NCT00962806|Behavioral|Lifestyle counseling|Baseline and final visit dietary and activity advice and weekly healthy lifestyle messages
16256416|NCT00962780|Biological|13-valent Pneumococcal Conjugate Vaccine (13vPnC)|13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
16256417|NCT00962780|Biological|23-valent Pneumococcal Polysaccharide Vaccine (23vPS)|23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
16256418|NCT00962780|Procedure|Blood draw|Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
16256419|NCT00962780|Procedure|Blood draw|1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
16256420|NCT00962767|Drug|gemtuzumab ozogamicin|2 IV infusions 6 mg/m2 administered monthly
16256421|NCT00962767|Drug|ATRA plus 6-MP and MTX|6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO
16256422|NCT00962754|Procedure|physician no insight in the fluid balance chart|physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded
16256423|NCT00962741|Drug|Etanercept|Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
16256424|NCT00962728|Device|Inspiratory Threshold Device (Res-Q-Gard ITD)|Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
16256425|NCT00962728|Device|Sham Inspiratory Threshold Device|Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
16256426|NCT00962715|Biological|Influenza Vaccine Trivalent Inactivated (TIV)|15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.
16256427|NCT00962715|Drug|Pegylated interferon (PEGrIFN-α, Pegasys)|180 μg (0.5 ml) before receiving TIV, through a needle under the skin.
16256428|NCT00962715|Drug|Interferon (IFNα, Roferon-A)|3 million units (0.5 ml) before receiving TIV, through a needle under the skin.
16256429|NCT00962702|Device|LAAx TigerPaw System|Exclusion of Left Atrial Appendage
16256430|NCT00962663|Drug|ICA-105665|Subjects randomized to receive ICA -105665 will receive 200 mg BID
16256431|NCT00962663|Drug|Ibuprofen|Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4.
16256432|NCT00962663|Drug|Placebo|"Subjects randomized to receive placebo will receive placebo to ICA
~-105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4."
16256433|NCT00962650|Device|Transgastric diagnostic peritoneoscopy with laparoscopic assistance|Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)
16256434|NCT00962637|Drug|Androxal|12.5 mg once daily
16256435|NCT00962637|Drug|Androxal|25 mg once daily
16256436|NCT00962637|Drug|AndroGel|5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
16256437|NCT00962637|Drug|Placebo|1 capsule daily
16256438|NCT00962624|Drug|meningococcal B vaccine & meningococcal ACYW conjugate vaccine|Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.
16256439|NCT00962611|Drug|Copanlisib (Aliqopa, BAY80-6946)|BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop.
16256440|NCT00962598|Drug|Omega 3 Fatty Acids|The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
16256441|NCT00962598|Dietary Supplement|Corn oil|The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
16256442|NCT00962585|Drug|Placebo|
16256443|NCT00962585|Drug|S-equol|"Eligible patients meeting all study entry criteria were randomly assigned to receive one of the following active treatments for 4 weeks:
~S-equol 10 mg BID (20 mg total daily dose)
~S-equol 50 mg BID (100 mg total daily dose)
~S-equol 150 mg BID (300 mg total daily dose)"
16256444|NCT00962572|Behavioral|Patient management|"Aggressive patient management will be implemented by a corps of patient manager volunteers backed by a transportation, nutrition, and social services network. The social services professionals will work with the volunteers to establish the support needed for each patient. The volunteer managers will in turn constantly monitor that such support is addressing the patient's ability to be treated. Access to sponsored housing will be coordinated. Nutritional support will be coordinated by the Dietary department and will consist of counseling, and supplements when necessary. Provision of supplemental feeding for housed patients will be arranged."
16256445|NCT00962533|Drug|telbivudine|telbivudine, 600mg, oral, daily
16256446|NCT00962533|Drug|telbivudine|telbivudine, 600mg, oral, daily
16256448|NCT00962507|Drug|panobinostat|10 mg every Monday and Thursday of a 28 day cycle. Dose escalation will be determined by the toxicities associated with treatment.
16256449|NCT00962507|Other|laboratory biomarker analysis|Pre-study, day 1 and day 26 samples to evaluation how the study drugs work in vitro (in a test tube).
16256450|NCT00962507|Other|pharmacological study|Pre-study, day 1 and day 26
16256451|NCT00962494|Behavioral|Cancer: Thriving and Surviving Online Workshop|
16256452|NCT00962481|Drug|Bimosiamose|
16256453|NCT00962481|Drug|Placebo|
16256454|NCT00962468|Other|COPD evidence based care pathway|A care pathways, as complex intervention, will be implemented.
16256455|NCT00962455|Other|e-learning & performance feedback|Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
16256456|NCT00962455|Other|usual practice|Usual practice regarding spirometry execution in family practice
16256457|NCT00962442|Drug|N-Acetylcysteine|300 mg/kg for 14 days, intravenously
16256458|NCT00962442|Drug|placebo|Glucosé 5% perfusion for 14 days, intravenously
16256459|NCT00962429|Drug|lipoic acid|Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.
16256460|NCT00962416|Device|Biolimus eluted from an erodable stent coating (Biomatrix)|The Biolimus-eluting stent (Biomatrix) has a corrugated ring design available in six and nine cell models and is laser cut from 316L VM stainless steel hypotube. The nominal dosage of Biolimus A9 goes from 133 to 442 microgram. The producer of the drug is Nippoon Kayaku Co., Ltd Takasaki Plant, 239, Iwahanamachi, Takasaki-shi, Gumma 370-1028 Japan. The biodegradable polymer is polylactic acid, which has become one of the most commonly used biodegradable polymers. Polylactic acid, its co-polymers, and mixtures have been evaluated in the preclinical, and clinical studies, revealing a favorable biocompatability profile. The polymer has been demonstrated to be safe when used as implant of drug release-control polymer for both animals and humans.
16256461|NCT00962416|Device|bare-metal stent (Gazelle)|A bare-metal stent of identical design without surface application of polymer and drug.
16256462|NCT00962403|Behavioral|Yoga treatment|The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions. In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
16256463|NCT00962390|Drug|S-equol|10mg S-equol 50mg S-equol, & 150mg S-equol
16256464|NCT00962390|Drug|Placebo|Placebo
16256465|NCT00962377|Procedure|Endomyocardial biopsy|Right ventricular endomyocardial biopsy in monitoring of asymptomatic heart transplant patients for acute cellular rejection
16256466|NCT00962377|Procedure|AlloMap Molecular Testing|Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.
16256467|NCT00962364|Biological|autologous bone marrow-derived cells|autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
16256468|NCT00962351|Procedure|Total Hip Replacement|
16256469|NCT00962338|Behavioral|Information|Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.
16256470|NCT00962325|Behavioral|Intervention to increase physical activity|This will be a 6-week preoperative intervention to increase structured walking activity. This will be accomplished through weekly individual face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal-setting, stimulus control, etc.
16256471|NCT00962312|Drug|capecitabine|
16256472|NCT00962312|Drug|lapatinib ditosylate|
16256473|NCT00962299|Drug|Beclomethasone|Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months
16256474|NCT00962299|Drug|Placebo|Placebo once a day by metered dose inhaler with spacer for 6 months
16256475|NCT00962286|Drug|Furosemide|"Subjects will receive 300 mg of lithium carbonate at 22.00 the day before the renal function tests.Intravenous catheters will be placed in each upper limb for infusion of clearance markers and blood sampling.A priming dose of inulin (50 mg/kg) and p-aminohippuric acid (8 mg/kg) will be administered. Thereafter, inulin and p-aminohippuric acid will be infused continuously. A 200-300 ml water load will be given during the first 60-min prime.
~Subjects will be started on furosemide p.o. 20 mg every 12 hours, starting on day 1 at 15.00 after the renal function studies. Nine doses will be taken, the last dose on day 4 at 7 am.
~In case the blood pressure does not decrease following 20 mg bid furosemide administration, the study will be repeated after 4 weeks using a dose of 40 mg p.o. bid."
16256476|NCT00962273|Behavioral|Interactive computerized learning resource|"In a series of interactive scenarios, participants can see themselves in stressful work situations that could arise during an influenza pandemic and reflect on effective ways to work out personal and interpersonal difficulties."
16256477|NCT00962273|Behavioral|Didactic computerized learning resource|In a non-interactive format (i.e., a series of audio presentations with accompanying PowerPoint-type slides) participants are given information on how to handle stressful work situations that could arise during an influenza pandemic.
16256478|NCT00962260|Drug|Plant cell expressed recombinant glucocerebrosidase (prGCD)|Intravenous infusion every two weeks at the dose level equal to each patient's previous imiglucerase dose before reduction or discontinuation due to shortage
16256479|NCT00962247|Device|Television reduction device|A TV allowance helps turn off the television when the time limits have been met.
16256480|NCT00962234|Other|Blood draws|Up to 4 blood draws will be required, in the amount of about 10 mL each
16256481|NCT00962234|Biological|Oral administration of stable isotope (deuterium)|1 mg deuterium-labeled water/kg body water (loading dose), and 0.5 mg/kg body water diluted in 1 L of normal water (maintenance dose) to be consumed over the following 16 hours
16256482|NCT00962234|Procedure|Metabolic rate testing|Metabolic rate testing is a painless, non-invasive test that takes about 1h. A metabolic cart is used, which detects the amount of oxygen and carbon dioxide the body uses. Patients will lie down on a bed for 30 minutes with lights dimmed and soft music to help them relax. After 30 minutes, a canopy will be placed over the patient's head and shoulders for 30 minutes for the analysis of breath samples. This test will be performed only once for this study.
16256483|NCT00962221|Procedure|laboratory analysis|laboratory analysis
16256484|NCT00962208|Device|orthokeratology lenses|Nightly use of orthokeratology to correct the refractive error for a period of two years
16256485|NCT00962208|Device|single-vision spectacle lenses|Daily use of spectacles to correct the refractive error for a period of two years
16256486|NCT00962195|Dietary Supplement|purple sweet potato (PSP)-juice|Daily oral intake of 3x 125 ml of PSP-juice or control juice
16256487|NCT00962182|Drug|STAN1|3-4 capsules/day at meals
16256488|NCT00962182|Drug|Placebo enzyme|3-4 capsules/day at meals
16256489|NCT00962182|Drug|STAN1+gluten|3-4 capsules/day at meals plus 500 mg gluten b.i.d
16256490|NCT00962169|Other|Behavioral and managerial|The quality improvement program is a multi-level intervention program to increase adherence to the Dutch physical therapy Guidelines for Low Back Pain. It consists of two program parts, one for practice quality managers and the other for individual therapists. The management part aims to increase commitment amongst practice owners towards high quality of care, including the appropriate use of guidelines, and addresses the structure and the culture of the physical therapy practice. This part of the program is based on the INK management model and the colour model of De Caluwé. The individual part of the intervention is aimed at increasing physical therapists' guideline adherence by raising awareness and improving recording and clinical reasoning. This part of the intervention is based on psychosocial and educational theories and especially on the principles of Self Regulation.
16256491|NCT00962169|Other|Behavioral and IT|The interventions makes use of an improved EPD for physical therapists. Compared to the existing EPDs, the EPD for the present study presents decision information for physical therapists. This decision information is directly based on the recently revised physical therapy guidelines for Low Back Pain and attached to the subsequent steps of clinical reasoning that are inherent to the diagnostic and treatment stages of the usual process of physical therapy care.
16256492|NCT00962156|Drug|6% Hydroxyethyl starch 130/0.4|Infusion for volume expansion in the ICU
16256493|NCT00962156|Drug|Ringers acetate|Infusion for volume expansion in the ICU
16256494|NCT00962143|Device|Achilles repair with OrthADAPT augmentation|Achilles repair with OrthADAPT augmentation
16256495|NCT00962143|Procedure|Achilles repair without OrthADAPT Augmentation|Achilles repair without OrthADAPT Augmentation
16256496|NCT00962130|Device|Continuous glucose monitoring system|one or two monitors will be placed in the tissue to be transferred
16256497|NCT00962104|Drug|Atomoxetine|40-120 milligrams (mg) taken by mouth, once daily for 10 weeks.
16256498|NCT00962104|Drug|Placebo|Taken by mouth, once daily for 10 weeks.
16256499|NCT00962091|Drug|Alisertib|Alisertib OS Alisertib PIC Alisertib PIC
16256500|NCT00962078|Other|continuous endurance training|at 60 percent of peak Watt
16256501|NCT00962078|Other|interval training|at 100 percent of peak Watt
16256502|NCT00962065|Drug|LX4211 Low Dose|A low dose of LX4211; daily oral intake for 28 days
16256503|NCT00962065|Drug|LX4211 High Dose|A high dose of LX4211; daily oral intake for 28 days
16256504|NCT00962065|Drug|Placebo|Matching placebo dosing with daily oral intake for 28 days
16256505|NCT00962039|Drug|Citalopram|Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
16256506|NCT00962039|Drug|Placebo|Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
16256507|NCT00962026|Drug|Rilonacept|Rilonacept given subcutaneously, dose per package labeling, once weekly.
16256508|NCT00962013|Device|Restoration® Modular Revision Hip System|Restoration® Modular Revision System
16256509|NCT00962000|Other|Dialysis Flow Rate Start 600mL/min|ABAB sequence where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
16256510|NCT00962000|Other|Dialysis Flow Rate Start 800mL/min|BABA sequence where B represents three consecutive treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min.
16256511|NCT00961987|Other|Collaborative model|Patients will be referred (if necessary) to an obstetrician who will be co-located in the Maternity Centre and who will be part of the collaborative model of maternity care.
16256512|NCT00961987|Other|Usual care|At present, if Maternity Centre patients require the specialized services of an obstetrician, the current standard of care is to refer them to obstetricians located offsite with no professional ties to the Maternity Centre
16256513|NCT00961974|Behavioral|Care Ambassador Intervention|Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
16256514|NCT00961974|Behavioral|Psychoeducational Intervention|"A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing diabetes burnout."
16256515|NCT00961961|Drug|Lithium / Fluoxetine|Individualized Daily Dosage
16256516|NCT00961961|Drug|Lithium / Placebo|Individualized Daily Dosage
16256517|NCT00961922|Other|Neurofeedback|30 sessions of neurofeedback will be given twice a week at the child's home. It will take about 15 weeks to complete the training.
16256518|NCT00961922|Other|Placebo feedback|Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.
16256519|NCT00961909|Drug|RO5095932|cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
16256520|NCT00961909|Drug|RO5095932|dose titration to target dose, sc once weekly for 6 weeks
16256521|NCT00961909|Drug|metformin|stable dose
16256522|NCT00961909|Drug|placebo|sc once weekly for 4 weeks
16256523|NCT00961896|Drug|Vehicle|Placebo cream
16256524|NCT00961896|Drug|LDE225 0.25%|
16256525|NCT00961896|Drug|LDE225 0.75%|
16256526|NCT00961883|Biological|NYVAC-B|New York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 ^7 PFU
16256527|NCT00961883|Biological|Placebo|Sodium Chloride for injection, delivered intramuscularly
16256528|NCT00961883|Biological|rAd5|Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^10 PFU
16256529|NCT00961883|Biological|rAd5|Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^9 PFU
16256530|NCT00961883|Biological|rAd5|Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^8 PFU
16256531|NCT00961870|Procedure|Forearm vibration|Mechanical loading with forearm vibration will be applied right radius in all groups.
16256532|NCT00961857|Drug|sitagliptin phosphate (+) metformin hydrochloride|place holder - do not post
16256533|NCT00961857|Drug|Comparator: metformin 500 mg|A single dose of metformin 500 mg tablets
16256534|NCT00961857|Drug|Comparator: sitagliptin|A single 50 mg tablet of sitagliptin
16256535|NCT00961857|Drug|Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet|A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
16256536|NCT00961857|Drug|Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet|A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
16256537|NCT00961857|Drug|Comparator: metformin 1000 mg|A single dose of metformin 1000 mg tablets
16256538|NCT00961844|Biological|Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion|
16256539|NCT00961844|Drug|Temozolomide|
16256540|NCT00961831|Drug|F-18 (BAY85-8050)|Cancer patients, injection of BAY 85-8050, PET/CT
16256541|NCT00961831|Drug|F-18 (BAY85-8050)|Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood
16256542|NCT00961805|Behavioral|Dance|Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
16256543|NCT00961805|Other|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
16256544|NCT00961792|Drug|Ethanol|Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
16256545|NCT00961792|Drug|Placebo|Beverage containing 0.0 g/kg alcohol to act as placebo
16256546|NCT00961792|Drug|Diphenhydramine|Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
16256547|NCT00961792|Drug|Caffeine|Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake
16256548|NCT00961779|Drug|NNZ-2566|Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.
16256549|NCT00961779|Drug|Placebo|Normal saline infusion
16256550|NCT00961766|Drug|BG00010 (Neublastin)|Single dose, weight-based IV administration
16256551|NCT00961766|Drug|Placebo|Single dose IV matched placebo
16256552|NCT00961753|Drug|optimized ibuprofen|day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals
16256553|NCT00961753|Drug|Standard Ibuprofen|day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals
16256554|NCT00961740|Behavioral|Cognitive Behavioural Therapy|See summary
16256555|NCT00961740|Other|Waitlist condition|See Summary
16256556|NCT00961727|Other|Bedside Paediatric Early Warning System (Bedside PEWS)|The Bedside PEWS is comprised of 4 components; [1] an expert derived, multi-centre validated severity of illness score, [2] an inter-professionally developed documentation record into which the severity of illness score is embedded, [3] a series of score-matched care recommendations based on the opinions of over 280 paediatric health care professionals, and [4] an educator-developed education-implementation program.
16256557|NCT00961714|Device|OsseoFix Spinal Fracture Reduction System|All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
16256558|NCT00961675|Drug|FST201 (dexamethasone 0.1% with povidone-iodine 1%)|4 gtt BID (twice a day)
16256559|NCT00961675|Drug|Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )|4 gtt BID (twice a day)
16256560|NCT00961662|Drug|D-Tagatose|powder to be dissolved in water prior to dosage.
16256561|NCT00961649|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16256562|NCT00961649|Drug|Brinzolamide ophthalmic suspension, 1%|
16256563|NCT00961649|Drug|Brimonidine tartrate ophthalmic solution, 0.2%|
16256564|NCT00961649|Other|Vehicle|Inactive ingredients used as placebo
16256565|NCT00961636|Drug|ER niacin (+) laropiprant (ERN/LRPT)|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
16256566|NCT00961636|Drug|ER niacin (+) laropiprant (ERN/LRPT)|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.
16256567|NCT00961636|Drug|Extended-release niacin (ERN)|Two 1g tablets ERN (2g total) once daily for 12 weeks.
16256568|NCT00961636|Drug|Placebo to ERN/LRPT|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks
16256569|NCT00961610|Behavioral|Internet peer-support group|"The Internet peer-support groups provided a self-guided space for communication, including an Internet discussion forum, a live chat room and a personal message system. No therapeutic content or information services were offered within the groups.
~All Internet groups were run in a browser-based software platform with access through the website of the Danish Cancer Society (http://www.cancer.dk). All discussions were protected by a password and communication was encrypted.
~The Internet groups in this study were all closed peer-support groups, accessible only by an invitation received by e-mail after registration for the study. The groups were open to access 24 h a day for 13 months from their individual starting date."
16256570|NCT00961597|Procedure|Meniscus repair for red/white tears without PRP|Same operation as experimental, only without the use of platelet rich plasma.
16256571|NCT00961597|Procedure|Meniscus repair with PRP|Meniscus repair with platelet rich plasma using vertical divergent suture techniques.
16256572|NCT00961571|Drug|sunitinib and capecitabine|Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
16256573|NCT00961558|Procedure|Varicocelectomy|Varicocelectomy
16256574|NCT00961532|Drug|DDAVP injection (desmopressin acetate)|0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
16256575|NCT00961506|Procedure|LESS cholecystectomy|LESS cholecystectomy
16256576|NCT00961506|Procedure|Laparoscopic cholecystectomy|laparoscopic cholecystectomy
16256577|NCT00961493|Behavioral|Acceptance based behavioral therapy|16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.
16256578|NCT00961493|Behavioral|Applied relaxation|16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.
16256579|NCT00961480|Drug|sitagliptin phosphate (+) metformin hydrochloride|place holder - do not post
16256580|NCT00961480|Drug|Comparator: metformin 500mg|A single dose of metformin 500 mg tablet
16256581|NCT00961480|Drug|Comparator: sitagliptin|A single dose of 50 mg sitagliptin tablet
16256582|NCT00961480|Drug|Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet|A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
16256583|NCT00961480|Drug|Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet|A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
16256584|NCT00961480|Drug|Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet|A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet
16256585|NCT00961480|Drug|Comparator: metformin 1000 mg|A single dose of metformin 1000 mg tablet
16256586|NCT00961480|Drug|Comparator: metformin 850 mg|A single dose of metformin 850 mg tablet
16256587|NCT00961467|Drug|Revlimid, Melphalan, Prednisone, Thalidomide|Thalidomide was administered at 50 mg/day.
16256588|NCT00961467|Drug|Revlimid, Melphalan, Prednisone, Thalidomide|Thalidomide was administered at 100 mg/day.
16256589|NCT00961454|Device|Photobiomodulation with a super-luminous light emitting diode|The treatment will consist of applying PBM in the form of a super-luminous LED with an output of 250 mW/cm2 at a wavelength of 815 nm with a full width half maximum of 40 nm when applied at 4 mm from the skin. The treatment will consist of the exposure to the light for 4 minutes (total delivered fluence per spot of 60 J/cm2) at each of 4 sites on the forehead that correspond to the 10-20 EEG sites, F3, and F4.
16256590|NCT00961441|Drug|Keppra XR|"Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
~Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days"
16256591|NCT00961415|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3-week cycle
16256592|NCT00961415|Drug|cisplatin|75mg/m2 iv on day 1 of each 3-week cycle
16256593|NCT00961415|Drug|pemetrexed|500mg/m2 iv on day 1 of each 3-week cycle
16256594|NCT00961402|Behavioral|Wellness Control|6-month wellness control
16256595|NCT00961402|Behavioral|Exercise Intervention|6 month exercise intervention
16256596|NCT00961376|Biological|PBMC re-infusion|Autologous PBMC re-infusion
16256597|NCT00961376|Biological|CD25 depletion|Autologous, CD25-depleted PBMC re-infusion
16256598|NCT00961363|Drug|Sitagliptin|sitagliptin 100 mg per day
16256599|NCT00961363|Drug|Placebo|Placebo
16256600|NCT00961350|Drug|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
16256601|NCT00961350|Drug|EC Aspirin 325|The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)
16256602|NCT00961337|Biological|Trivalent inactivated influenza vaccine|one dose
16256603|NCT00961324|Drug|insulin degludec|The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
16256604|NCT00961324|Drug|insulin glargine|The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
16256605|NCT00961311|Procedure|Percutaneous Coronary Intervention|Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
16256606|NCT00961311|Device|Sprinter Legend 1.25mm Balloon Catheter|Balloon Angioplasty
16256607|NCT00961298|Drug|Duloxetine|All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
16256608|NCT00961259|Drug|Fenofibric Acid 35 mg Tablet|1 x 35 mg tablet administered after an overnight fast of at least 10 hours
16256609|NCT00961259|Drug|Fenofibric Acid 35 mg Tablet|3 x 35 mg tablets administered after an overnight fast of at least 10 hours
16256610|NCT00961259|Drug|Fenofibric Acid 105 mg Tablet|105 mg tablet administered after an overnight fast of at least 10 hours
16256611|NCT00961246|Behavioral|general health information|participants received general health information
16256612|NCT00961246|Behavioral|individually-tailored intervention|participants received individually-tailored intervention
16256613|NCT00961233|Drug|inhaled/swallowed budesonide|medication will be nebulized and then swallowed
16256614|NCT00961233|Drug|viscous/swallowed budesonide|viscous suspension of budesonide will be swallowed
16256615|NCT00961220|Drug|Carmustine|Applied topically
16256616|NCT00961220|Other|Laboratory Biomarker Analysis|Correlative studies
16256617|NCT00961220|Drug|O6-Benzylguanine|Given IV
16256618|NCT00961207|Drug|Aliskiren|Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
16256619|NCT00961207|Drug|Aliskiren|Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
16256620|NCT00961194|Drug|Ketamine|"Initial dosage: 250 mg/5 ml
~Three doses of ketamine will be tested:
~0.35 mg/kg
~0.7 mg/kg
~1.4 mg/kg Each patient will receive the indicated dose of oral ketamine or placebo once and if there are not adverse events, he will be able to continue the treatment three times a day, during 7 days (between visit 2 and 3).
~The oral ketamine will be administered in form of syrup."
16256621|NCT00961181|Device|Paclitaxel Releasing Balloon|Percutaneous coronary intervention with paclitaxel releasing balloon
16256622|NCT00961168|Other|Volume Control Ventilation|Mechanical ventilation at a constant tidal volume of 6 mL/kg.
16256623|NCT00961168|Other|Pressure Control Ventilation|Mechanical ventilation at a constant airway pressure of 25-30 cm H2O
16256624|NCT00961155|Drug|cyklezonid|160 mcg once daily
16256625|NCT00961155|Drug|montelukast sodium|5 or 10 mg according to age once daily
16256626|NCT00961155|Drug|placebo|fluticasone placebo twice daily, montelukast placebo once daily
16256627|NCT00961155|Drug|formoterol 12 mcg twice daily|formoterol 12 mcg twice daily will be given to children for 3 months
16256628|NCT00961142|Drug|Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)|Conditioning with Fludarabine 30 mg/m2/24h day-8 to -4, Thiotepa 2x5 mg/kg day -3, Melphalan 60 mg/m2 day -2 to -1 and Thymoglobuline (ATG)1.5mg/kg/day day -9 to -6. PBSC depleted of CD3 and CD19 cells by immunomagnetic depletion on CliniMACS.
16256629|NCT00961116|Drug|Fenofibric Acid (Fibricor™) 105 mg Tablet|1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours
16256630|NCT00961116|Drug|Fenofibrate (Tricor®) 145 mg Tablet|1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours
16256631|NCT00961090|Drug|Aminolevulinic Acid|20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
16256632|NCT00961077|Drug|S-1 (TS-1) and Oxaliplatin (Oxalitin)|"S-1(TS-1) 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours
~every 3 weeks"
16256633|NCT00961064|Drug|Eltrombopag|Eltrombopag will be initiated at 50 mg/day (Asians 25 mg/day) and dose adjusted up to 150mg/day based response and safety
16256634|NCT00961051|Device|Investigational MPS|Multi-purpose solution
16256635|NCT00961051|Device|Opti-Free|Multi-purpose solution
16256636|NCT00961038|Drug|Ciprofloxacin (PulmoSphere, BAYQ3939)|32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
16256637|NCT00961038|Drug|Ciprofloxacin (PulmoSphere, BAYQ3939)|48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
16256638|NCT00961038|Drug|Placebo|Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)
16256639|NCT00961025|Drug|DA-1229|"single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg
~multiple dose study : DA-1229 5,10,20,40mg"
16256640|NCT00961025|Drug|Placebo|placebo
16256641|NCT00961012|Procedure|The Big Squeeze|Trunk release as per MSIP protocol. Standing at the foot of the bed, facing the subject, Experimenter A grasps both ends of the flat sheet to pull the trunk forward and away from the mattress surface. As the trunk release procedure is performed, Experimenter A checks to verify that the laser beam shines through to the opposite wall to confirm that the shoulders have cleared the mattress.
16256642|NCT00960999|Radiation|Single-fraction stereotactic body radiation therapy (SBRT)|34 Gy in 1 fraction to the prescription line at the edge of the planning target volume (PTV). The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.
16256643|NCT00960999|Radiation|Multiple-fraction stereotactic body radiation therapy (SBRT)|48 Gy in four 12 Gy fractions to the prescription line at the edge of the planning target volume (PTV). Treatments are given on 4 consecutive calendar days, but at least 18 hours apart. The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.
16256644|NCT00960986|Drug|Duloxetine hydrochloride|po, QD
16256645|NCT00960973|Drug|Menatetrenone|Menatetrenone 30 mg, 3 times a day for 4 weeks
16256646|NCT00960973|Drug|Placebo|Placebo
16256647|NCT00960960|Drug|Bevacizumab|Bevacizumab will be administered IV at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
16256648|NCT00960960|Drug|Pictilisib|Pictilisib will be administered PO QD on escalating doses.
16256649|NCT00960960|Drug|Letrozole|Letrozole will be administered PO at a dose of 2.5 mg QD for for each 28-day cycle.
16256650|NCT00960960|Drug|Paclitaxel|Paclitaxel will be administered IV at a dose of 90 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle.
16256651|NCT00960960|Drug|Trastuzumab|Trastuzumab will be administered IV at a dose of 2-4 mg/kg on on Days 1, 8, 15, and 22 of each 28-day cycle.
16256652|NCT00960934|Drug|MK-5442|MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.
16256653|NCT00960934|Drug|Placebo|Dose-matched oral placebo to MK-5442
16256654|NCT00960934|Dietary Supplement|Vitamin D3|Vitamin D3, two 400 IU tablets daily throughout the study.
16256655|NCT00960934|Dietary Supplement|Calcium carbonate|Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.
16256656|NCT00960921|Drug|Iron sucrose|An intravenous infusion of 100 mg of iron is administered on days 0, 4, 8, 12, 16 and 20 of the study, giving a total of six iron infusions for each participant in the iron group over the course of the 28-day study period.
16256657|NCT00960921|Drug|Normal saline|An intravenous infusion of 100 ml of normal (0.9 %) saline is administered on days 0, 4, 8, 12, 16 and 20 of the study, giving a total of six saline (placebo) infusions for each participant in the saline group over the course of the 28-day study period.
16256658|NCT00960908|Device|Endeavor Resolute stents|2nd generation ZES
16256659|NCT00960908|Device|Endeavor Sprint stent|1st generation ZES
16256660|NCT00960882|Drug|DMMET-01|1050.6 mg daily for 30 days
16256661|NCT00960869|Drug|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
16256662|NCT00960869|Drug|EC-Aspirin 325 mg|The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)
16256663|NCT00960856|Drug|Fenofibric Acid 105 mg Tablet|One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
16256664|NCT00960856|Drug|Fenofibric Acid 105 mg Tablet|One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
16256665|NCT00960856|Drug|Fenofibric Acid 105 mg Tablet|One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
16256666|NCT00960856|Drug|Fenofibric Acid 105 mg Tablet|One 105 mg tablet administered after an overnight fast of at least 10 hours.
16256667|NCT00960843|Device|Intraband pressure recording system|Intraband pressure will be measured by a pressure recording system.
16256668|NCT00960843|Other|Conventional Adjustment|Band adjustments will be made via conventional standard of care (e.g., volume, hunger).
16256669|NCT00960830|Drug|mirtazapine|mirtazapine 15 mg daily tablets
16256670|NCT00960830|Drug|mirtazapine|15 mg daily
16256671|NCT00960817|Drug|Statin, aspirin|
16256672|NCT00960817|Drug|Dipyridamole|
16256673|NCT00960804|Biological|Tanezumab|IV, 5 mg dose, q 8 weeks, for up to 80 weeks
16256674|NCT00960804|Biological|Tanezumab|IV, 10 mg dose, q 8 weeks, for up to 80 weeks
16256675|NCT00960804|Other|Placebo|IV, q 8 weeks, for up to 80 weeks
16256676|NCT00960791|Device|AZD1656|Oral single dose
16256677|NCT00960778|Drug|nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)|Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.
16256678|NCT00960778|Other|denicotinized cigarettes (Quest 3 cigarettes)|Cigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch.
16256679|NCT00960752|Drug|gp100|1 ml of gp100 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.
16256680|NCT00960752|Drug|R848 gel|Applied to the gp100 vaccine injection site immediately following the injection, allowed to air dry for 30 minutes then covered with gauze dressing.
16256681|NCT00960752|Drug|MAGE-3|1 ml of MAGE-3 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.
16256682|NCT00960739|Drug|Topotecan hydrochloride|The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle)
16256683|NCT00960739|Procedure|Autologous hematopoietic stem cell transplantation|Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG
16256684|NCT00960739|Radiation|iobenguane I 131|444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity
16256685|NCT00960739|Radiation|total-body irradiation|the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)
16256686|NCT00960726|Drug|NOV-002|60 mg delivered daily subcutaneously for up to 12 months.
16256687|NCT00960713|Drug|Rituximab (MABTHERA® or RITUXAN®).|patients can be included in the study whatever the dosage used. Most patients will receive a classical 375 mg/m2 dose every week during four times (J0-J7-J14-J21).
16256688|NCT00960700|Device|Visual Acuity|Assessment of visual acuity
16256689|NCT00960700|Device|Contrast sensitivity|Assessment of contrast sensitivity
16256690|NCT00960700|Device|Reading Speed|Assessment of reading speed
16256691|NCT00960700|Procedure|Eye Health|Examination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure.
16256692|NCT00960687|Drug|Fenofibric Acid (Fibricor™) 105 mg Tablet|1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast.
16256693|NCT00960687|Drug|Fenofibrate (Tricor®) 145 mg Tablet|1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.
16256694|NCT00960674|Procedure|Tactile massage|Gentle massage given for one hour by specially educated massage therapists, usually registered nurses.
16256695|NCT00960674|Behavioral|Relaxation|Relaxation by a CD with relaxation exercises, at least one hour per week for ten weeks
16256696|NCT00960661|Drug|exenatide|subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
16256697|NCT00960661|Drug|insulin lispro|titrated based on pre-meal glucose level; three times a day
16256698|NCT00960661|Drug|Metformin|
16256699|NCT00960661|Drug|Insulin/ Glargine|
16256700|NCT00960648|Device|Xience/Promus|Active prospective registration of patients receiving everolimus-eluting stent
16256701|NCT00960648|Device|Cypher|Retrospective historical controls that received sirolimus-eluting stent
16256702|NCT00960635|Drug|1,25-dihydroxy-vitamin D3 (calcitriol)|
16256703|NCT00960635|Drug|placebo|pill without agent
16256704|NCT00960622|Drug|Truvada|Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
16256705|NCT00960622|Drug|Combivir|Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
16256706|NCT00960622|Drug|Trizivir|Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)
16256707|NCT00960609|Procedure|Ultrasound guided liver resection|
16256708|NCT00960596|Behavioral|Health promotion and health education for smoking habits|We provide the education to intervention group.
16256709|NCT00960583|Other|Exercise program|24 group exercise sessions during 12 weeks
16256710|NCT00960583|Other|Routine follow-up|Advice to stay active
16256711|NCT00960570|Drug|Efavirenz 600 mg|Efavirenz 600 mg administered as a single oral dose on the morning of Day 1.
16256712|NCT00960570|Drug|Efavirenz 600 mg|Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.
16256713|NCT00960570|Drug|Fenofibric Acid|Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.
16256714|NCT00960557|Drug|Combretastatin A1 Diphosphate (OXi4503)|OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.
16256715|NCT00960544|Drug|Capecitabine|Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
16256716|NCT00960531|Biological|ACC-001+ QS21 (3mcg)|ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
16256717|NCT00960531|Biological|ACC-001 (10 mcg) + QS-21|ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
16256718|NCT00960531|Biological|ACC-001+QS-21 (30mcg)|ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
16256719|NCT00960518|Drug|adefovir|adefovir at 10 mg daily for 48 weeks
16256720|NCT00960518|Procedure|TACE|An emulsion that consisted of 50 mg of cisplatin and 10 mL of lipiodol at a volume ratio of 1:1 was injected into the blood supply artery of the tumor under fluoroscopic guidance. The injection could be slowed or discontinued if retrograde flow occurred. Embolization was subsequently performed with granules of gelatin sponge particles.
16256721|NCT00960505|Other|Alternate day fasting|
16256722|NCT00960505|Other|Calorie restriction|
16256723|NCT00960505|Other|Control diet|
16256724|NCT00960492|Drug|XL184|XL184 will be administered daily as a single oral agent supplied as 25- and 100-mg capsules
16256725|NCT00960492|Drug|temozolomide|TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules. The starting dose will be 75 mg/m2/day given daily with concurrent RT for 6 weeks
16256726|NCT00960492|Drug|temozolomide|TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules. The starting dose will be 200 mg/m2/day given for 5 consecutive days and repeated every 28 days.
16256727|NCT00960492|Radiation|Radiation Therapy|Subjects will receive RT consisting of fractionated focal irradiation administered using 1.8-2 Gy/fraction, daily for 5 days/week for 6-7 weeks, for a total dose of up to 60 Gy.
16256728|NCT00960492|Drug|temozolomide|TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules.
16256729|NCT00960479|Drug|Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)|
16256730|NCT00960479|Drug|Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)|
16256731|NCT00960466|Behavioral|Distress Thermometer and Problems List|When using the distress thermometer and problem list (DT&PL), the nurse or radiographer asks the patient to indicate distress over the past week on a visual analogue scale from 0 (no distress) to 10 (high distress). Next, from a list of 42 items, patients identify practical, family, emotional, spiritual or physical problems that have caused distress. The completion of the DT&PL should be a collaborative exercise with patients able to review what is written on the assessment sheet. Potential solutions will be discussed which may involve the following: i) concerns that can be resolved immediately (e.g. providing information, prescribing an analgesic); ii) concerns that require patient actions (e.g. participating in support groups); iii) concerns that require a referral (e.g. mental health specialist, social or pastoral care). The meeting will end with a summary plan of action.
16256732|NCT00960466|Behavioral|Usual psychosocial support|If patients express concerns about psychosocial issues, then clinic staff will discuss these issues, offer advice or make a referral as they see fit. However, no formal time will be set aside to monitor patient distress using the DT, elicit problems using the PL or develop a plan of action based on these tools. Because of the nature of the intervention, both the patient and the therapist will be aware of treatment assignment.
16256733|NCT00960453|Drug|Sitagliptin|"Dosage form: 25mg, 50mg ,100mg
~Amount: 25mg, 50mg, 100mg
~Frequency and duration: once a day, for 4 days, including 5 days washout periods"
16256734|NCT00960440|Drug|CP-690,550|Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
16256735|NCT00960440|Drug|CP-690,550|Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
16256736|NCT00960440|Drug|Placebo|Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
16256737|NCT00960440|Drug|CP-690,550|Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
16256738|NCT00960440|Drug|Placebo|Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
16256739|NCT00960440|Drug|CP-690,550|Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
16256740|NCT00960427|Drug|systemic chemotherapy|
16256741|NCT00960427|Genetic|RNA analysis|
16256742|NCT00960427|Genetic|gene expression analysis|
16256743|NCT00960427|Genetic|reverse transcriptase-polymerase chain reaction|
16256744|NCT00960427|Other|immunohistochemistry staining method|
16256745|NCT00960427|Other|laboratory biomarker analysis|
16256746|NCT00960427|Procedure|endoscopic biopsy|
16256747|NCT00960427|Procedure|neoadjuvant therapy|
16256748|NCT00960427|Procedure|sigmoidoscopy|
16256749|NCT00960427|Radiation|radiation therapy|
16256750|NCT00960414|Behavioral|SHINE|Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
16256751|NCT00960375|Behavioral|BTSCS|BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
16256926|NCT00959244|Other|mass spectrometry|Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
16257108|NCT00958035|Drug|bimatoprost ophthalmic 0.03% solution|Apply one drop of study medication along the upper eyelid margin once daily in the evening
16256752|NCT00960375|Behavioral|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting.
16256753|NCT00960362|Drug|AGS-009|Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
16256754|NCT00960362|Drug|placebo|Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
16256755|NCT00960349|Drug|Cediranib|Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
16256756|NCT00960349|Drug|Cisplatin|Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
16256757|NCT00960349|Drug|S-1|Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
16256758|NCT00960349|Drug|Cisplatin|60mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
16256759|NCT00960349|Drug|Capecitabine|Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
16256760|NCT00960336|Drug|pegylated liposomal doxorubicin hydrochloride|
16256761|NCT00960323|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone in the morning on Day 1.
16256762|NCT00960323|Drug|Atorvastatin|Atorvastatin (1 x 40 mg tablet) administered once daily on Days 15-28.
16256763|NCT00960323|Drug|Colchicine|A single dose of 0.6 mg colchicine administered with a single dose of 40 mg atorvastatin in the morning on Day 28 after an overnight fast.
16256764|NCT00960310|Drug|Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)|
16256765|NCT00960310|Drug|Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)|
16256766|NCT00960297|Drug|Carboplatin|Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
16256767|NCT00960297|Drug|Paclitaxel|Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
16256768|NCT00960297|Drug|Bevacizumab|Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
16256769|NCT00960284|Drug|capecitabine|Given orally
16256770|NCT00960284|Drug|cisplatin|Given IV
16256771|NCT00960284|Drug|epirubicin hydrochloride|Given IV
16256772|NCT00960284|Drug|fluorouracil|Given IV
16256773|NCT00960284|Drug|gemcitabine hydrochloride|Given IV
16256774|NCT00960271|Procedure|EBUS|a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time
16256775|NCT00960258|Drug|Regorafenib (BAY73-4506)|The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg
16256776|NCT00960245|Drug|Nadolol (1 x 80 mg) Tablets (Invamed, Inc)|
16256777|NCT00960245|Drug|Corgard (1 x 80 mg) Tablets (Bristol Laboratories)|
16256778|NCT00960232|Drug|Cholecalciferol|40.000 IU cholecalciferol per week for 6 months
16256779|NCT00960232|Drug|placebo|placebo
16256780|NCT00960219|Drug|D-amino acid oxidase inhibition (DAAOI-1)|1g/day(500mg BID), oral, for 6 weeks
16256781|NCT00960219|Drug|placebo|1# BID, oral, for 6 weeks
16256782|NCT00960206|Device|Trident® Ceramic Insert/Trident® AD HA Acetabular Shell|Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
16256783|NCT00960206|Device|Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell|Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
16256784|NCT00960206|Device|OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell|OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
16256785|NCT00960193|Drug|Colchicine|A single dose of 0.6 mg colchicine administered alone in the morning on Day 1 and a single dose of 0.6 mg colchicine administered with Seville orange juice in the morning on Day 18 after an overnight fast of at least 10 hours.
16256786|NCT00960193|Other|Seville Orange Juice|240 mL of Seville orange juice administered in the morning and evening on Days 15 to 18.
16256787|NCT00960180|Drug|MR1817|
16256788|NCT00960180|Drug|Placebo|
16256789|NCT00960167|Radiation|3DCRT or IMRT|"All enrolled patients will receive 3.5 Gy per fraction (five fractions per week) at the following levels;
~Dose escalation by 7 Gy in 2 fractions to maximum of 63 Gy, as follows:
~Dose Level I: 3.5 Gy for 12 fractions (42 Gy total) Dose Level II: 3.5 Gy for 14 fractions (49 Gy total) Dose Level III: 3.5 Gy for 16 fractions (56 Gy total) Dose Level VI: 3.5 Gy for 18 fractions (63 Gy total)"
16256790|NCT00960154|Device|PEAK PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision
16256791|NCT00960154|Procedure|Traditional Electrosurgery with scalpel|The skin incision will be performed using a standard scalpel; the subcutaneous dissection will be performed with traditional electrosurgery using the Cut and Coagulation modes.
16256792|NCT00960141|Drug|montelukast sodium|montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
16256793|NCT00960141|Drug|Comparator: loratadine|loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
16256794|NCT00960141|Drug|Comparator: placebo|placebo tablet, taken orally once daily at bed time for 2 weeks
16256795|NCT00960128|Drug|somatropin|The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
16256796|NCT00960128|Drug|somatropin|The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.
16257021|NCT00958672|Other|Endoscopic capsule|Endoscopic capsule
16257022|NCT00958659|Other|laboratory biomarker analysis|Correlative studies
16257023|NCT00958646|Other|Osteopathic Manipulation|Standardized rib raising protocol
16257024|NCT00958646|Other|Placebo|Light touch control procedure
16256797|NCT00960115|Biological|Tecemotide (L-BLP25)|After receiving a single low-dose cyclophosphamide, participants will receive weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) will be administered every 6 weeks until progressive disease (PD).
16256798|NCT00960115|Drug|Single low dose cyclophosphamide|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg/m^2) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
16256799|NCT00960115|Biological|Placebo|After receiving single dose of saline, participants will receive weekly subcutaneous vaccinations with placebo that matches with tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo will be administered every 6 weeks until PD.
16256800|NCT00960115|Other|Saline|A single dose of saline (sodium chloride, 9 grams per liter [g/L]) will be administered intravenously, 3 days prior to the start of placebo.
16256801|NCT00960102|Device|cochlear implant|Multichannel Nucleus cochlear implant
16256802|NCT00960102|Device|hearing aid|Phonak hearing aid
16256803|NCT00960089|Device|LIQUICURE|Topical treatment, 1 time/day, 5 days/week
16256804|NCT00960076|Drug|Saxagliptin|5mg oral tablet once daily
16256805|NCT00960076|Drug|Metformin XR|500mg oral tablet once daily
16256806|NCT00960076|Drug|Metformin XR|750mg, 2 tablets once daily
16256807|NCT00960063|Drug|Temozolomide|
16256808|NCT00960063|Drug|Vincristine|
16256809|NCT00960063|Drug|Ifosfamide|
16256810|NCT00960063|Drug|Irinotecan|
16256811|NCT00960063|Biological|Robatumumab|
16256812|NCT00960063|Drug|Doxorubicin|
16256813|NCT00960063|Drug|Cyclophosphamide|
16256814|NCT00960063|Drug|Etoposide|
16256815|NCT00960037|Dietary Supplement|Oral vitamin D3|Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.
16256816|NCT00960037|Dietary Supplement|Placebo equivalent|One capsule daily for 8 weeks
16256817|NCT00960024|Behavioral|Individual Placement and Support-vocational rehabilitation|Individual contact with an employment specialist, who works according to 7 core principles according to SE/IPS. 1) competitive employment as primary goal, 2) rapid job search, 3) eligibility based on client choice, 4) job search based on to client preferences, 5) integration with the mental health care team, 6) availability of time unlimited support at work 7) benefits counseling.
16256818|NCT00960024|Behavioral|Vocational rehabilitation available|The participants are offered vocational rehabilitation available at site
16256819|NCT00960011|Device|PROGRIP|Use of PROGRIP mesh for open inguinal hernia repair
16256820|NCT00960011|Device|POLYPROPYLENE|Use of Polypropylene mesh in open inguinal hernia repair
16256821|NCT00959998|Other|Self-administered Acupressure|
16256822|NCT00959985|Device|Compression Sleeve|Worn for a minimum of 12 hours per day
16256823|NCT00959985|Device|Short-Stretch Compression Bandage|Worn overnight at least 5 nights of the week
16256824|NCT00959972|Drug|Varenicline|Participants randomized to varenicline will be administered 0.5 mg/day for 3 days, 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for an additional 11 weeks.
16256825|NCT00959972|Drug|Transdermal Nicotine Patch|Participants randomized to NRT will apply the patch immediately on the first day and each morning thereafter for 12 weeks. Doses of NRT will be 21 mg/day for the first 6 weeks, 14 mg/day for 4 weeks, then 7 mg/day for 2 weeks.
16256826|NCT00959959|Drug|TOK-001|2 capsules (325 mg each), once per day
16256827|NCT00959959|Drug|TOK-001|4 capsules (325 mg each), once per day
16256828|NCT00959959|Drug|TOK-001|6 capsules (325 mg each), once per day
16256829|NCT00959959|Drug|TOK-001|3 capsules (325 mg each), once per day
16256830|NCT00959959|Drug|TOK-001|3 capsules (325 mg each), once per day with supplement
16256831|NCT00959959|Drug|TOK-001|6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
16256832|NCT00959959|Drug|TOK-001|8 capsules (325 mg each), once per day
16256833|NCT00959959|Drug|TOK-001|8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
16256834|NCT00959946|Drug|Bosutinib|Doses in part 1 include bosutinib 200 mg QD; bosutinib 300 mg QD. Depending on safety bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).
16256835|NCT00959946|Drug|Capecitabine|Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14; capecitabine 625 mg/m2 BID on days 1-14. Depending on safety, capecitabine can also be administered at 1000 mg/m2 BID. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).
16256836|NCT00959933|Drug|Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)|
16256837|NCT00959933|Drug|Rebetol 200 Capsules (Schering Corporation, U.S.A.)|
16256838|NCT00959920|Procedure|Indwelling catheter|Indwelling bladder catheter will remain in place until time of delivery.
16256839|NCT00959920|Procedure|Intermittent straight catheterization|intermittent straight catheterization will be performed on an as needed basis until time of delivery.
16256840|NCT00959907|Drug|BOTULINUM TOXIN TYPE-A|"On Visit 1 (Day 0):
~Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
~Dysport®: 4 units will be injected in the left or right forehead side.
~Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)"
16256841|NCT00959894|Drug|Etravirine (Intelence)|Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
16256842|NCT00959894|Drug|Truvada|Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day
16256843|NCT00959881|Drug|Donepezil plus placebo|5- and 10-mg tablets, single dose
16256844|NCT00959881|Drug|Donepezil|5- and 10-mg tablets, single dose
16256845|NCT00959881|Drug|Begacestat|6 x 50-mg capsules, single dose
16257109|NCT00958035|Drug|vehicle sterile solution (placebo)|Apply one drop of study medication along the upper eyelid margin once daily in the evening
16256846|NCT00959868|Drug|OGX-427|OGX-427 drug product is in 25mg/mL injection in a mannitol-phosphate buffer solution packaged to deliver at least 8mL volume from a 10mL Type I, clear glass vial (ammonium sulfate treated) with Teflon coated bromobutyl rubber stopper and sealed with an aluminum, red, flip-off over seal. The drug product is aseptically compounded and sterilized via sterile filtration prior to aseptic filling.
16256847|NCT00959855|Other|Pulmonary Rehabilitation|Sixteen, two hourly pulmonary rehabilitation sessions over an eight week period. The first hour will consist of an individualized exercise programme based on exercise field tests. The second hour will consist of an educational component. A home exercise programme of inspiratory muscle training (Threshold(R)IMT (respiratory muscle trainer re:HS730EU-001 single patient use) starting between 15% -30% of PiMax and progress weekly to 60% for 30 mins a day/ 5 dats a week with an inspiratory/expiratory ratio of 3:4. Patients will also be encouraged to walk or undertake an home exercise programme based on a Borg score of between 3 and 5 an additional 3 days a week.
16256849|NCT00959829|Other|Music and message|Experimental group: music and message Control group: silence
16256850|NCT00959816|Drug|ABT-614|Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.
16256851|NCT00959803|Drug|PF-04447943|3 mg solution, oral single dose.
16256852|NCT00959803|Drug|PF-04447943|10 mg solution, oral single dose.
16256853|NCT00959803|Drug|PF-04447943|25 mg solution, oral single dose.
16256854|NCT00959803|Drug|Placebo|Solution, oral single dose.
16256855|NCT00959803|Drug|PF-04447943|25 mg solution, oral twice daily for 7 days.
16256856|NCT00959803|Drug|Placebo|Solution, oral twice daily for 7 days.
16256857|NCT00959790|Dietary Supplement|Vegetables|200 or 50 grams of vegetables daily for four weeks
16256858|NCT00959790|Dietary Supplement|energy restriction|Consume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions.
16256859|NCT00959777|Drug|DA-3031|
16256860|NCT00959777|Drug|Filgrastim|
16256861|NCT00959764|Drug|Oral Calcitonin Tablets|Oral Calcitonin tablets along with matching placebo intranasal spray
16256862|NCT00959764|Drug|Intranasal Calcitonin|Intranasal Calcitonin Spray
16256863|NCT00959764|Drug|Placebo tablets and placebo intranasal spray|Oral Placebo Tablets/Intranasal placebo spray
16256864|NCT00959751|Drug|NXN-188|200 mg capsules, 600 mg, PRN
16256865|NCT00959751|Drug|Placebo|200 mg capsules with no active ingredient designed to match the NXN-188 capsules
16256866|NCT00959738|Procedure|Diverting loop ileostomy with rod|Diverting loop ileostomy with rod
16256867|NCT00959738|Procedure|diverting loop ileostomy without rod|diverting loop ileostomy without rod
16256868|NCT00959725|Drug|Infliximab (intravitreal, 2.0mg/0.05ml)|One injection of intravitreal infliximab (2.0mg/0.05ml).
16256869|NCT00959712|Behavioral|ECA Interaction|The technology uses a computer character (Embodied Conversational Agent (ECA)) that simulates face-to-face conversation. The ECA talks to the patient and the patient responds by tapping a touch-screen.
16256870|NCT00959699|Drug|PegIFN-2b|PegIFN-2b (1.5 μg/kg/week subcutaneously)
16256871|NCT00959699|Drug|RBV|Ribavirin (600-1400 mg/day, orally, divided into two daily doses)
16256872|NCT00959699|Drug|Placebo to Boceprevir|Placebo to boceprevir (orally, three times per day)
16256873|NCT00959699|Drug|Boceprevir|Boceprevir (800 mg, orally, three times per day)
16256874|NCT00959686|Drug|Bendamustine|Bendamustine at the dose of 120 mg/m2 IV over 60 minutes on days 1 and 2 every 21 days for 6 cycles
16256875|NCT00959660|Behavioral|Exercise|walking, treadmill and bicycle exercise
16256876|NCT00959660|Dietary Supplement|Dietary Intervention|Subjects will be provided meals and instructions for individual food selections.
16256877|NCT00959660|Behavioral|Diet and exercise|Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.
16256878|NCT00959660|Other|Attention Control|control group- continue their previously randomized life style
16256879|NCT00959647|Drug|Vismodegib|Vismodegib was supplied in capsules.
16256880|NCT00959647|Drug|FOLFOX|FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration.
16256881|NCT00959647|Drug|FOLFIRI|FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration.
16256882|NCT00959647|Drug|Bevacizumab|Bevacizumab was supplied as a solution for intravenous administration.
16256883|NCT00959634|Drug|ABT-126|Dose administered twice daily on Study Days 1-10
16256884|NCT00959634|Drug|Placebo|Dose administered twice daily on Study Days 1-10
16256885|NCT00959621|Drug|Aspirin|ASA 100 mg once daily per os
16256886|NCT00959621|Drug|Klexane|Klexane 40 mg sc once daily (HABENOX 1 and 2), Klexane 40 mg twice daily in HABENOX 3
16256887|NCT00959621|Drug|Klexane and ASA|Klexane 40 mgx 1 sc and ASA 100 mg po
16256888|NCT00959608|Behavioral|Think Health! program|Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).
16256889|NCT00959608|Behavioral|Basic Plus program|15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
16256890|NCT00959595|Drug|EMLA cream|The study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment.
16256891|NCT00959595|Drug|EMLA cream|50g applied according to description of intervention
16257196|NCT00957242|Drug|warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
16257197|NCT00957242|Drug|placebo|Oral placebo (1mg or 2.5mg)
16256892|NCT00959582|Procedure|Comparator: 18-F-FDG PET/CT and Volumetric CT|Patients will receive standard-of-care therapy (carboplatin or cisplatin monotherapy, or a two-drug combination where one is platinum). FDG-PET/CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, and if patients are progression-free at the end of Cycle 6. Volumetric CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, after Cycle 3 of chemotherapy (optional), and if patients are progression-free at the end of Cycle 6 and at 40 weeks after Cycle 1 dosing.
16256893|NCT00959569|Drug|Esmolol|esmolol (1-3 mg/kg) during cardiac surgery
16256894|NCT00959569|Drug|Placebo|normosaline (same ml of the study drug)
16256895|NCT00959556|Other|laboratory biomarker analysis|
16256896|NCT00959543|Other|MRI|MRI and clinical investigation
16256897|NCT00959530|Procedure|lingualized occlusion|occlusal surface arranged by lingualized occlusion
16256898|NCT00959530|Procedure|Full Bilaterally Balanced Articulation|occlusal surface arranged by Full Bilaterally Balanced Articulation
16256899|NCT00959517|Drug|artesunate (AS)|Recommended dosage over 3 days (for all interventions)
16256900|NCT00959517|Drug|sulphadoxine-pyrimethamine (SP)|
16256901|NCT00959517|Drug|Chloroquine (CQ)|
16256902|NCT00959517|Drug|primaquine (PQ)|
16256903|NCT00959478|Behavioral|Educational Tool & Carbon Monoxide Alarm|Based on the recommendations from the expert panel and focus group meetings, Fast Facts about Carbon Monoxide was developed to be an educational tool aimed at helping parents understand the dangers of CO and the need CO alarms in every home. In addition, this tool will help parents select and purchase the correct CO alarm, as well as properly install and maintain the alarm in their home. Each parent assigned to the intervention group will be given a Fast Facts about Carbon Monoxide educational tool and a Kidde Nighthawk Carbon Monoxide Alarm at enrollment.
16256904|NCT00959465|Biological|H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)|Two injections at a 21-day interval (Days 1 and 22)
16256905|NCT00959452|Behavioral|Cognitive behavioural therapy|16 sessions vs 5 sessions of cognitive behavioural therapy
16256906|NCT00959439|Drug|Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)|
16256907|NCT00959439|Drug|Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)|
16256908|NCT00959426|Drug|PF-04620110|Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.
16256909|NCT00959426|Drug|Placebo|Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.
16256910|NCT00959400|Drug|Fentanyl Transdermal|Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days.
16256911|NCT00959387|Drug|Induction TP chemotherapy|3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.
16256912|NCT00959387|Radiation|Chemoradiotherapy (CRT)|Patients were treated with 2-dimensional radiation therapy planning (6MV photon beams). A combination of lateral-opposed portals, anterior and lateral wedged fields was used to treat the primary tumor and the lymph nodes. The primary tumor, macroscopically affected lymph nodes and bilateral cervical plus supraclavicular lymph chains were treated with five fractions of 2Gy per week for 5 weeks (up to a total of 50Gy). Gross tumor volume was defined as the primary gross tumor or involved node, and this measure was based on clinical, radiological and endoscopic examinations. An additional margin of 1.0cm was added to the GTV to create the CTV. A boost of five fractions of 2Gy per week for 2 additional weeks (up to a total dose of 70Gy) was prescribed to the CTV plus a margin of 1.0cm.
16256913|NCT00959374|Device|V-Loc 180/90 Wound Closure Device|Barbed absorbable suture
16256914|NCT00959374|Device|3-0 Monocryl Absorbable Sutures|3-0 Monocryl Absorbable Suture (non-barbed)
16256915|NCT00959361|Behavioral|pharmaceutical care|consultation with the pharmacists and usual care
16256916|NCT00959335|Drug|Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)|
16256917|NCT00959335|Drug|Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)|
16256918|NCT00959322|Device|LenSx 550 Laser System|Femtosecond laser used to create capsulotomy incision.
16256919|NCT00959309|Behavioral|Strategies to decrease screen time in children|"15 minute session about the health impact of screen time in children and strategies to decrease screen time (removing televisions from the child's bedroom, budgeting screen time, providing a contingency plan for time spent not watching TV, encouraging family meal time, and implementing a one week television turn off, where children are encouraged to spend one week without watching TV/videos). Activities for the child include reading a story about television viewing (The Berenstain Bears and Too Much TV), and creating a list of non TV related activities to replace TV time. The intervention group will receive a CPS handout titled 'Promoting Good Television Habits' and a calendar with stickers for the television turn off.
~Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')"
16256920|NCT00959309|Behavioral|Non-Strategical Media Education|Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')
16256921|NCT00959296|Device|Various|Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator.
16256922|NCT00959283|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16256923|NCT00959283|Other|Pharmacological Study|Correlative studies
16256924|NCT00959244|Other|high performance liquid chromatography|Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
16256925|NCT00959244|Other|laboratory biomarker analysis|The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
16256927|NCT00959244|Other|medical chart review|Information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease, body mass index, age at menarche, menopausal status (pre- or peri- menopausal or postmenopausal), age at menopause if applicable, chemotherapy regimen (if applicable), radiation therapy (if applicable), smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy and disease type.
16256928|NCT00959231|Drug|cyclophosphamide|
16256929|NCT00959231|Drug|cyclosporine|
16256930|NCT00959231|Drug|fludarabine phosphate|
16256931|NCT00959231|Drug|mycophenolate mofetil|
16256932|NCT00959231|Other|laboratory biomarker analysis|
16256933|NCT00959231|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16256934|NCT00959231|Procedure|umbilical cord blood transplantation|
16256935|NCT00959231|Radiation|total-body irradiation|
16256936|NCT00959218|Drug|Dronabinol|oral solution, daily dose up to 15 mg, treatment up to 2.5 years
16256937|NCT00959218|Drug|Placebo|oral solution
16256938|NCT00959205|Device|CARTO 3D|CARTO (3D Electroanatomic imaging)
16256939|NCT00959205|Device|Angiography|Conventional fluoroscopically guided activation mapping
16256940|NCT00959192|Biological|ACC-001|IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
16256941|NCT00959192|Other|QS-21|IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
16256942|NCT00959192|Other|QS-21|IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
16256943|NCT00959166|Other|PET scan|PET brain scan
16256944|NCT00959153|Device|LithoSpace Extracorporeal Shockwave Lithotripter|Shockwave therapy to break up kidney stones
16256945|NCT00959140|Device|CD3+ T cell depletion|"The peripheral blood stem cell product is engineered to deliver a dose of 15 to 20 x10^7 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation. Following collection, CD3+ T cells will be enumerated and a portion of the product containing 15 to 20 x10^7 CD 3+ cells/kg will be set aside. The remainder of the product will be depleted of CD3+ T cells.
~Following CD3+ T cell depletion, the CD3+ T cell depleted product will then be combined with the unmanipulated product to provide the specified levels of CD3+ T cells/kg recipient body-weight. The graft is infused into the patient on the same day as selected and within 24 hours of donor aphaeresis."
16256946|NCT00959127|Drug|ARRY-438162 (MEK162), MEK inhibitor; oral|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
16256947|NCT00959114|Biological|ALV003|ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
16256948|NCT00959114|Biological|ALV003 placebo|ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
16256949|NCT00959101|Drug|repaglinide and metformin combination tablet|Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
16256950|NCT00959101|Drug|repaglinide and metformin combination tablet|Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
16256951|NCT00959101|Drug|repaglinide|Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
16256952|NCT00959101|Drug|metformin|Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet
16256953|NCT00959075|Dietary Supplement|Vitamin B1|100 mg Twice a day
16256954|NCT00959075|Dietary Supplement|Placebo|Sugar pill
16256955|NCT00959062|Drug|clonidine|5 mcg/kg (maximum 200 mcg) enterally every 6 hours
16256956|NCT00959062|Drug|placebo|Preparation visually identical to clonidine.
16256957|NCT00959049|Biological|CSL's Influenza Virus Vaccine (Afluria)|0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
16256958|NCT00959049|Biological|Influenza Virus Vaccine (Fluzone)|0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
16256959|NCT00959036|Drug|ATN-103|10 mg every 4 weeks until week 12
16256960|NCT00959036|Drug|ATN-103|10 mg every 8 weeks until week 12
16256961|NCT00959036|Drug|ATN-103|30 mg every 4 weeks until week 12
16256962|NCT00959036|Drug|ATN-103|80 mg every 4 weeks until week 12
16256963|NCT00959036|Drug|ATN-103|80 mg every 8 weeks until week 12
16256964|NCT00959036|Drug|Placebo|Placebo every 4 weeks
16256965|NCT00959036|Drug|Methotrexate|
16256966|NCT00959023|Other|laboratory biomarker analysis|
16256967|NCT00959023|Other|medical chart review|
16256968|NCT00959023|Other|questionnaire administration|
16256969|NCT00959010|Dietary Supplement|omega-3 triglycerides|capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months.
16256970|NCT00959010|Dietary Supplement|Placebo|capsules containing middle chain triglycerides
16256971|NCT00958997|Drug|18F-FP-DTBZ (18F-AV-133)|The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).
16256972|NCT00958997|Biological|Arginine-hydrochloride|A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
16256973|NCT00958971|Drug|TKI258|All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles.
16256974|NCT00958958|Other|multifaceted strategy|"There are multifaceted Interventions Including
~Distribution of educational materials: distribution of published or printed recommendations for clinical care.
~Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
~Reminders
~Practical training"
16257055|NCT00958399|Dietary Supplement|Fiber made from corn starch + soluble fiber|25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
16257147|NCT00957710|Behavioral|Errorless learning|Language testing,20 sessions of language therapy, and 2 neuroimaging sessions for participants with progressive aphasia Language testing and 1 imaging session for healthy controls
16256975|NCT00958932|Behavioral|Speech recognition|The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.
16256976|NCT00958932|Behavioral|Speech recognition|Automated, speech recognition telephone calls
16256977|NCT00958919|Drug|naloxone|10 mg naloxone in 25 ml total volume
16256978|NCT00958919|Drug|normal saline|25 ml
16256979|NCT00958906|Drug|Infliximab (intravitreal, 2.0mg/0.05ml)|One injection of intravitreal infliximab (2.0mg/0.05ml).
16256980|NCT00958893|Drug|25 mg Proellex|one 25 mg capsules
16256981|NCT00958880|Behavioral|Group Cognitive Behavioral Therapy|"5 weeks of group CBT for Social Anxiety. The aim of CBT is to help participants become more comfortable with social situations
~One arm will receive placebo augmented Group Cognitive Behavioral Therapy and the other will receive yohimbine hydrochloride augmented cognitive behavioral therapy."
16256982|NCT00958880|Drug|Yohimbine Hydrochloride|Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions.
16256983|NCT00958880|Drug|Sugar Pill|Participants in the placebo (sugar pill) augmented arm will receive 4 doses of a sugar pill before 4 of the 5 group cognitive behavioral therapy sessions.
16256984|NCT00958867|Behavioral|Exercise program (AT)|Six-month, twice-weekly aerobic training (AT) program
16256985|NCT00958867|Behavioral|Exercise training (RT)|Six-month, twice-weekly resistance training (RT) program
16256986|NCT00958867|Behavioral|Exercise training (S & R; control)|Six-month, twice-weekly stretch & relax (S & R; control) program
16256987|NCT00958854|Drug|cyclophosphamide|
16256988|NCT00958854|Drug|fludarabine phosphate|
16256989|NCT00958854|Drug|thalidomide|
16256990|NCT00958854|Other|laboratory biomarker analysis|
16256991|NCT00958841|Drug|pasireotide LAR|Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.
16256992|NCT00958828|Device|Nelfilcon A contact lens|Spherical, soft contact lens for daily disposable wear
16256993|NCT00958828|Device|Narafilcon A contact lens|Spherical, soft contact lens for daily disposable wear
16256994|NCT00958802|Other|Platelet-rich plasma (PRP)|PRP was extracted from total blood and TGF-b1 was used as indicator
16256995|NCT00958802|Other|Chondrocyte culture with FBS medium|Microtia chondrocyte culture with FBS medium only
16256997|NCT00958776|Drug|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
16256998|NCT00958776|Drug|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
16256999|NCT00958763|Behavioral|Motivational Interviewing, Single - MIS|The Motivational Interviewing Single Arm is delivered individually to participants in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.
16257000|NCT00958763|Behavioral|Motivational Interviewing Group|The Motivational Interviewing Group Arm is delivered to participants in groups in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator and with the group, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.
16257001|NCT00958763|Other|Usual Care Group - UCG|The Usual Care Arm is delivered to participants in three brief time-equivalent health promotion sessions. Each session focuses on health promoting activities such as the importance of diet and exercise, need for physical and mental health assessment and enhanced coping for those afflicted with a history of drug and alcohol addiction. In addition participants receive liver health promotion education. Participants are also provided referrals to alcohol treatment programs in the community and offered the 3 series hepatitis A/B vaccine
16257002|NCT00958750|Drug|minoxidil|the investigators compared two different formulations and concentrations of minoxidil in this study
16257003|NCT00958737|Drug|FOLFOX regimen|Given IV
16257004|NCT00958737|Drug|fluorouracil|Given IV
16257005|NCT00958737|Drug|leucovorin calcium|Given IV
16257006|NCT00958737|Drug|oxaliplatin|Given IV
16257007|NCT00958737|Drug|XELOX regimen|
16257008|NCT00958737|Drug|Capecitabine|oral
16257009|NCT00958724|Drug|Neratinib|
16257010|NCT00958724|Drug|Vinorelbine|
16257011|NCT00958711|Device|Unite Biomatrix|Collagen based, decellularized equine pericardial dressing for skin surface wounds
16257012|NCT00958711|Other|Saline and Gauze|gauze moistened with sterile saline
16257013|NCT00958698|Other|Communication Intervention|Ancillary studies
16257014|NCT00958698|Other|Educational Intervention|Ancillary studies
16257015|NCT00958698|Other|Internet-Based Intervention|Ancillary studies
16257016|NCT00958698|Procedure|Psychosocial Assessment and Care|Ancillary studies
16257017|NCT00958698|Other|Quality-of-Life Assessment|Ancillary studies
16257018|NCT00958698|Other|Questionnaire Administration|Ancillary studies
16257019|NCT00958685|Dietary Supplement|ginger|Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
16257020|NCT00958685|Dietary Supplement|placebo|Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
16257025|NCT00958633|Drug|Escitalopram|"Escitalopram will be prescribed in the dose range 10-30 mg daily.
~In patients randomized to the 8-week group, escitalopram will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit.
~The dose of escitalopram (or matching placebo) may be decreased in 10 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 10-30 mg daily at all time points."
16257026|NCT00958633|Drug|Wellbutrin XL|"Bupropion XL will be prescribed in the dosage range 150-450 mg daily.
~In patients randomized to the 8-week group, bupropion XL will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit.
~The dose of bupropion XL (or matching placebo) may be decreased in 150 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 150-450 mg daily at all time points."
16257027|NCT00958620|Procedure|Shock Wave Therapy|Extracorporal shock-wave therapy
16257028|NCT00958607|Behavioral|Timing it Right Stroke Family Support Person Intervention|Intervention delivered by a stroke support person (SSP) in-person during acute care & by telephone during inpatient rehabilitation and community discharge. SSP provides support, information & guidance and gives caregivers Stroke Family Support guide as a resource. SSP will have 1 contact with the caregiver during acute care and a 2nd contact during the last week of inpatient acute or rehabilitation care. The 1st contact while the caregiver is at home will occur 2-3 weeks after the stroke survivor has been discharged from inpatient care and then every four weeks until the caregiver passes the marker question. SSP will then encourage caregiver to contact them if they have any specific questions. The SSP will make one final contact about 8 weeks later
16257029|NCT00958607|Behavioral|Self-directed program|Participants in this arm of the trial will have family caregivers self-direct their use of the Timing it Right Stroke Family Support guide. The research assistant will instruct the caregivers how to self-manage their support needs by providing instruction on how to use the guide, which has an additional section regarding self-management. Caregivers will also be instructed that the guide is organized according to the phases of a stroke survivors' recovery. They will be instructed to review the information in each chapter as it becomes relevant to their current situation
16257030|NCT00958581|Drug|Tranexamic Acid|For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.
16257031|NCT00958581|Drug|Normal Saline|Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.
16257032|NCT00958581|Drug|Epsilon aminocaproic acid|For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.
16257033|NCT00958568|Drug|Olanzapine and Fluoxetine combination (OFC)|"Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks.
~Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks.
~Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks."
16257034|NCT00958568|Drug|Fluoxetine|25 or 50 mg/day fixed dosing for 27 weeks
16257035|NCT00958542|Procedure|Surgical fusion|Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
16257036|NCT00958529|Dietary Supplement|Inulin Fiber Supplement|Orange juice fortified with 0, 5g, and 10g of 2 inulin products
16257037|NCT00958516|Drug|LEO 29102 cream|LEO 29102 cream in different doses and the cream vehicle
16257038|NCT00958503|Drug|Thiamphenicol|750 and 1500 mg/day;tablets
16257039|NCT00958503|Drug|Placebo|Matched tablets without active ingredient
16257040|NCT00958490|Other|Walking program|4 week physical activity walking program
16257041|NCT00958477|Biological|EMD 525797|Subjects will be administered with 250 milligram (mg), 500 mg, 1000 mg or 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of week 6 were continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject is no longer benefitted from the treatment as per Investigator's discretion.
16257042|NCT00958464|Procedure|MRI|MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate dimeglumine 2- [Gd-DTPA2-] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging.
16257043|NCT00958451|Drug|Paricalcitol|"Patients will receive 1mcg once daily orally if iPTH is less than 500pg/ml;
~Patients will receive 2mcg once daily orally if iPTH is more than 500pg/ml. Duration of administration will be 16 weeks."
16257044|NCT00958451|Drug|Ergocalciferol|"If baseline 25 OHD level is less than 5ng/mml: ergocalciferol 50,000 units once a week orally for 12 weeks, then 50,000 units monthly for total duration of 16 weeks.
~If baseline 25 OHD is between 5 and 15mg/ml: Ergocalciferol 50,000 units once a week orally for 4 weeks, then 50,000 units once a month for total duration of 16 weeks.
~If baseline 25 OHD level is between 16 and 30ng/ml: Ergocalciferol 50,000 units orally once every 4 weeks for 16 weeks."
16257045|NCT00958438|Drug|Placebo|Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
16257046|NCT00958438|Drug|Rilonacept|Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
16257047|NCT00958438|Drug|Rilonacept|Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
16257048|NCT00958425|Device|Hyaluronic acid gel|Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
16257049|NCT00958425|Device|Saline|Normal saline, 0.9 mL, intradermal over 2 cm area, once
16257050|NCT00958412|Drug|Proellex®|one (1) 25 mg capsule daily
16257051|NCT00958399|Dietary Supplement|Placebo|Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
16257052|NCT00958399|Dietary Supplement|Resistant Starch|25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
16257053|NCT00958399|Dietary Supplement|Resistant starch + soluble fiber|25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
16257054|NCT00958399|Dietary Supplement|Fiber made from corn starch|25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
16257056|NCT00958386|Drug|Panitumumab+irinotecan|"Panitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days.
~Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab.
~Each treatment cycle will have a duration of 14 days."
16257057|NCT00958360|Other|Interdisciplinary Low Vision Service|Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
16257058|NCT00958360|Other|Basic Low Vision Service|Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
16257059|NCT00958347|Device|Omnifit HA Hip Stem|Total Hip Replacement with Omnifit HA Hip Stem
16257060|NCT00958334|Drug|Proellex®|25 mg daily (two 12.5 mg capsules)
16257061|NCT00958321|Procedure|computed tomography|
16257062|NCT00958321|Radiation|3-dimensional conformal radiation therapy|
16257063|NCT00958321|Radiation|fludeoxyglucose F 18|
16257064|NCT00958321|Radiation|radiation therapy treatment planning/simulation|
16257065|NCT00958308|Other|BIO-K+ CL-1285®|A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
16257066|NCT00958308|Other|Placebo|Placebo is devoid of microorganisms.
16257067|NCT00958282|Drug|lisdexamfetamine/Behavior Therapy|
16257068|NCT00958282|Other|placebo|
16257069|NCT00958269|Drug|dutogliptin|100 mg QD
16257070|NCT00958269|Drug|dutogliptin|200 mg QD
16257071|NCT00958269|Drug|placebo|
16257072|NCT00958269|Drug|sitagliptin|25 mg QD
16257073|NCT00958269|Drug|sitagliptin|50 mg QD
16257074|NCT00958256|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.
16257075|NCT00958256|Drug|Rituximab|375 mg/m^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.
16257076|NCT00958256|Drug|Cyclophosphamide|300 mg/m^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle
16257077|NCT00958256|Drug|Mesna|600 mg/m^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.
16257078|NCT00958256|Drug|G-CSF|5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.
16257079|NCT00958243|Biological|CSL's 2009 H1N1 Influenza Vaccine (CSL425)|0.5 mL intramuscular injection on Day 0 and Day 21
16257080|NCT00958243|Biological|CSL's 2009 H1N1 Influenza Vaccine (CSL425)|0.25 mL intramuscular injection on Day 0 and Day 21
16257081|NCT00958243|Biological|Placebo|Placebo
16257082|NCT00958230|Device|dCell Vascular Patch|Implantation of a dCell Vascular Patch as part of an Endarterectomy
16257083|NCT00958217|Behavioral|Cognitive Processing Therapy-Modified (CPT-M)|Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills, reduce depression and substance relapse. CPT-M was delivered in individual 1-hour sessions once weekly.
16257084|NCT00958217|Behavioral|Integrated Cognitive Behavioral Therapy (ICBT)|Psychotherapy that focuses on thoughts and behaviors associated with depression with the goal of developing skills to reduce depression symptoms. We have integrated substance relapse prevention skills. ICBT was delivered in individual 1-hour sessions once weekly.
16257085|NCT00958204|Procedure|Light treatment|Light therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks.
16257086|NCT00958204|Procedure|Negative ion therapy|Negative ion therapy: from a negative ion generator with an output of 200 trillion ions per second per cubic centimeter, for 30 minutes per day upon waking in the morning, for 8 weeks
16257087|NCT00958204|Drug|Placebo|Placebo Pill: one oral tablet each day, for 8 weeks.
16257088|NCT00958204|Drug|Fluoxetine|Fluoxetine: 20 mg oral tablet each day, for 8 weeks
16257089|NCT00958191|Device|Trident® X3 Polyethylene Insert|Trident® X3 Polyethylene Insert
16257090|NCT00958178|Drug|Oxygen|Experimental: Low flow Oxygen for 30 seconds then high flow for 3.5 minutes. Active comparator: High flow Oxygen for 4 minutes.
16257091|NCT00958165|Device|CardioFocus EAS-AC|PVI for PAF
16257092|NCT00958152|Drug|VCH-222|Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
16257093|NCT00958152|Drug|VCH-222|Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
16257094|NCT00958152|Drug|VCH-222|Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
16257095|NCT00958152|Drug|telaprevir|Tablet, Oral, 1125 mg, q12h, Days 18-37
16257096|NCT00958139|Other|Permethrin|Permethrin 0.5% treatment of clothing one time
16257097|NCT00958139|Other|Placebo|water sprayed on clothing one time
16257098|NCT00958126|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
16257099|NCT00958126|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
16257100|NCT00958126|Biological|Placebo|Vaccine diluent, thimerosal 0.01% (weight/volume).
16257101|NCT00958100|Drug|tenofovir emtricitabine raltegravir|switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
16257102|NCT00958100|Drug|Lamivudine Abacavir Raltegravir|Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
16257103|NCT00958100|Drug|Abacavir free|Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.
16257104|NCT00958074|Drug|vorinostat|Given PO
16257105|NCT00958074|Other|flow cytometry|correlative study
16257106|NCT00958074|Other|laboratory biomarker analysis|correlative study
16257107|NCT00958048|Device|non-invasive ventilation|CPAP, BiPAP
16257110|NCT00958022|Drug|LBH589 and carboplatin with etoposide|"LBH589 will be given in oral formulation starting at a dose of 10 mg (Dose Level 1) 3x/week (2 days apart, e.g. Mon, Wed, Fri), during 2 weeks out of 3-weekly dosing schedule. After establishing the MTD at a 2 out 3 weeks dosing schedule, a 3 out of 3 weeks dosing schedule will be tested at that dose. This schedule will be adopted in the absence of limiting toxicities. Will be continued weekly after completion of 6 cycles of combo chemotherapy until progression or intolerable toxicities.
~Etoposide: Cycles 1-6: 100 mg/m² IV over 60 mins, Days 1-3 every 21 days for 6 cycles Carboplatin: commercially available as a sterile lyophilized powder available in single dose vials containing 50mg, 150mg, or 450mg of carboplatin. Each vial contains equal parts by weight of carboplatin & mannitol. Commercial supplies will be used for this study. It will be administered as an i.v. infusion over 30 minutes. The dose will be calculated based on patient's body weight at each treatment visit."
16257111|NCT00958009|Device|Rebidose®|The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection
16257112|NCT00957996|Drug|Peramivir|300 mg twice daily
16257113|NCT00957996|Drug|Peramivir|600 mg once daily
16257114|NCT00957983|Drug|BGC20-1531|oral administration followed by Prostaglandin E2 infusion
16257115|NCT00957970|Device|Stemless femoral component|Total hip femoral component anatomically designed for a proximal fit without a stem
16257116|NCT00957970|Device|IPS, Depuy cementless femoral stem|Anatomical proximal fitted cementless stemmed femoral component
16257117|NCT00957944|Drug|rotigotine transdermal patch (Neupro®)|Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
16257118|NCT00957931|Procedure|Bone marrow transplantation|Bone marrow transplantation using matched unrelated donors, reduced intensity conditioning regimen, and co-transplanting mesenchymal stromal cells derived from parental bone marrow.
16257119|NCT00957931|Biological|Mesenchymal Stromal Cells|
16257120|NCT00957918|Drug|nicotine|Oral capsule self administered in escalating doses from 1 mg to 6 mg, 4 times a day. Each dose is is taken for two weeks, except the highest dose, which is taken for 4 weeks. At the end of 10 weeks, the dose is tapered down over 9 days. Subject is continued on study through week 14.
16257121|NCT00957918|Other|placebo comparator|oral capsules containing only excipient will be self-administered with the same regimen as the active drug, 4 times a day, approximately every 6 hours for 10 weeks and nine days. Study is continued through week 14.
16257122|NCT00957905|Drug|Alvocidib Hydrochloride|Given IV
16257123|NCT00957905|Drug|Fluorouracil|Given IV
16257124|NCT00957905|Drug|Leucovorin Calcium|Given IV
16257125|NCT00957905|Drug|Oxaliplatin|Given IV
16257126|NCT00957879|Dietary Supplement|Ergocalciferol|Ergocalciferol 50000 international units by mouth weekly for 12 weeks
16257127|NCT00957879|Dietary Supplement|Calcitriol|Calcitriol 0.5 mcg by mouth daily for 12 weeks
16257128|NCT00957866|Drug|Pegylated Interferons (Peg-IFN) and Ribavirin|A anti-viral regimen with a combination of pegylated Interferons (Peg-IFN) and Ribavirin
16257129|NCT00957853|Drug|Cetuximab|First dose of 400 mg/m^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m^2 on week 2 and 3 (if applicable) given over 1 hour.
16257130|NCT00957853|Drug|IMC-A12|6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).
16257131|NCT00957853|Procedure|Surgical tumor resection|Surgical tumor resection on Day 10.
16257132|NCT00957840|Procedure|NIRS, aEEG, and CSF concentration of biomarkers|NIRS and aEEg will be done twice weekly, and CSF will be analyzed with each reservoir tap
16257133|NCT00957827|Drug|keflex|keflex 500 mg BID 5 days
16257134|NCT00957827|Drug|placebo|placebo BID for five days
16257135|NCT00957814|Behavioral|Nutritional education|Systematic nutritional orientation program
16257136|NCT00957801|Drug|Testosterone injection|100 mg single IM injection
16257137|NCT00957801|Drug|Testosterone gel|Testosterone gel 10 mg. administered topically daily for seven days
16257138|NCT00957801|Drug|Medrol|Medrol 6 day dose pack with an additional 4mg dose on day 7
16257139|NCT00957788|Drug|NST-001|Comparison of different dosages of drug.
16257140|NCT00957775|Behavioral|Usual care|Participants will receive the usual care (e.g., individual therapy, group therapy, family therapy, self-help groups) provided at the treatment site.
16257141|NCT00957775|Behavioral|Computer-delivered ACRA|Participants and willing caregivers will receive a computer-delivered intervention for 12 weeks, based on the Adolescent Community Reinforcement Approach to substance abuse treatment.
16257142|NCT00957762|Other|Body composition|Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC
16257143|NCT00957749|Drug|cPMP|Intravenous solution administered daily. Dose titrated from 80 μg/kg on Days 1-12 to 120 μg/kg on Days 13-34 to 160 μg/kg for days 35-90.
16257144|NCT00957736|Genetic|polymorphism analysis|Will assess the SNPs present in both the donor and to host and correlate the SNPs with outcome based in the NIH consensus criteria for cGVHD. Candidate SNPs will include but are not limited to TGF-β18, mannose binding lectin19, myeloperoxidase, HSP 70, minor histocompatability antigens, KIR, CCL513, NOD2/CARD1512, TNFα11, TNF R II, IL-1010, 11, IL-1317, IL-620, IFN-γ20, IL-1 RA21, IL-2315, and IL-1516. Other candidate genes will be assessed on current review of the literature and candidate SNPs will be added based on their relationship to aGVHD, cGVHD, autoimmune disease, pharmacogenetics, and other immunologic processes. The genes will be assessed for gene frequency using the HapMap and SNP databases prior to statistical analysis.
16257145|NCT00957736|Other|laboratory biomarker analysis|Will assess the SNPs present in both the donor and to host and correlate the SNPs with outcome based in the NIH consensus criteria for cGVHD. Candidate SNPs will include but are not limited to TGF-β18, mannose binding lectin19, myeloperoxidase, HSP 70, minor histocompatability antigens, KIR, CCL513, NOD2/CARD1512, TNFα11, TNF R II, IL-1010, 11, IL-1317, IL-620, IFN-γ20, IL-1 RA21, IL-2315, and IL-1516. Other candidate genes will be assessed on current review of the literature and candidate SNPs will be added based on their relationship to aGVHD, cGVHD, autoimmune disease, pharmacogenetics, and other immunologic processes. The genes will be assessed for gene frequency using the HapMap and SNP databases prior to statistical analysis.
16257146|NCT00957723|Device|Triathlon® CR Total Knee System|The purpose is to evaluate the Triathlon® CR Total Knee System.
16257148|NCT00957684|Drug|eslicarbazepine acetate|once-daily oral tablet
16257149|NCT00957684|Drug|placebo|once daily placebo comparator
16257150|NCT00957671|Drug|Recombinant human growth hormone|200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
16257151|NCT00957658|Device|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem
16257152|NCT00957619|Drug|pentoxyfilline|The total dose of 1 mg/kg/h will be used. At the preoperative day half of the daily dose will be given as a 4-hour short-term infusion within 24 hours before surgery. Afterwards, a continuous intravenous infusion of PTX 1 mg/kg of body weight per hour will be started intra-operatively and will be continued for a total of 72 hours after surgery.
16257153|NCT00957619|Drug|Placebo|This group will be treated with saline solution at the same time points. The infusion volume and infusion rate of saline solution correspond to that of the PTF group.
16257154|NCT00957606|Procedure|blood sampling, DXA-scan, bone scintigraphy|Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times
16257155|NCT00957593|Drug|Oxytocin|Continuation of oxytocin once in active labor
16257156|NCT00957593|Drug|Oxytocin discontinuation|Oxytocin will be stopped once in active labor
16257157|NCT00957580|Drug|Pimasertib|Pimasertib will be administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
16257158|NCT00957580|Drug|Pimasertib|Pimasertib will be administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
16257159|NCT00957580|Drug|Pimasertib|Pimasertib will be administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose escalation will proceed to 75 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
16257160|NCT00957580|Drug|Pimasertib|Pimasertib will be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
16257161|NCT00957580|Drug|Pimasertib|Pimasertib will be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
16257162|NCT00957554|Drug|irbesartan/amlodipine|Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily
16257163|NCT00957554|Drug|irbesartan|Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily
16257164|NCT00957541|Device|Paradym CRT + Physiological Diagnosis (PhD)|All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
16257165|NCT00957528|Drug|Testosterone|Weekly im injections of 100 mg testosterone enanthate.
16257166|NCT00957528|Drug|Placebo|Weekly IM injections of sesame oil.
16257167|NCT00957502|Device|ENTact™ Septal Stapler|1 year aged septal staples
16257168|NCT00957502|Device|ENTact™ Septal Stapler|18 Month Aged Staples
16257169|NCT00957489|Other|Dynamax appliance|
16257170|NCT00957489|Other|Twin-block appliance|
16257171|NCT00957476|Dietary Supplement|Omega-3 Fish Oil|800mg DHA and 1200mg EPA or the equivalent of a placebo PO (by mouth) once a day from enrollment (prior to 16 weeks gestation) until delivery.
16257172|NCT00957437|Drug|AZD1305|Single Oral Dose, ER formulation 1
16257173|NCT00957437|Drug|AZD1305|ER formulation 1, bid for 5 days
16257174|NCT00957437|Drug|AZD1305|Single Oral Dose, ER formulation 2
16257175|NCT00957424|Behavioral|telephone-based intervention|10-15 minute web-based survey on a computer
16257176|NCT00957424|Drug|nicotine replacement therapy|One week supply
16257177|NCT00957424|Other|informational intervention|
16257178|NCT00957424|Other|internet-based intervention|
16257179|NCT00957424|Other|questionnaire administration|Given out week 2, 3 and 4.
16257180|NCT00957411|Biological|cetuximab|Given IV
16257181|NCT00957411|Drug|cisplatin|Given IV
16257182|NCT00957385|Drug|Revlimid|10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops.
16257183|NCT00957372|Drug|eslicarbazepine acetate|oral tablet, 800 mg or 1200 mg once daily
16257184|NCT00957372|Drug|placebo (Part I)|once daily placebo comparator
16257185|NCT00957372|Drug|ESL - Open-label Extension (Part II)|Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day
16257186|NCT00957359|Drug|Psilocybin|Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
16257187|NCT00957359|Drug|Niacin|Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
16257188|NCT00957346|Drug|Mifepristone+misoprostol|single dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
16257189|NCT00957346|Drug|Placebo+Misoprostol|placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
16257190|NCT00957333|Other|ketamine|
16257191|NCT00957320|Drug|Sirolimus|Sirolimus daily po days 1 through 28, Dose level 0: 0.25 mg/m2 po daily Dose level 1: 0.5 mg/m2 po daily Dose level 2: 1 mg/m2 po daily Dose level 3 1.5 mg/m2 po daily Dose level 4 2 mg/m2 po daily
16257192|NCT00957320|Drug|PEG-asparaginase|Subjects will receive PEG-asparaginase at a fixed weekly dose, as per published reports in relapsed childhood ALL.
16257193|NCT00957268|Drug|Alogliptin|Alogliptin tablets
16257194|NCT00957255|Device|OrthoADAPT|soft tissue augmentation device
16257195|NCT00957255|Procedure|Standard of care|Standard of care rotator cuff repair
16257198|NCT00957229|Drug|GDC-0449|capsule, 150 mg, one pill daily, 18 months
16257199|NCT00957216|Drug|Placebo (sugar pill)|placebo: 2 wafers 4 times a day
16257200|NCT00957216|Drug|Coenzyme Q10|300mg wafers; 2 wafers 4 times a day
16257201|NCT00957203|Drug|Istradefylline|Oral istradefylline (KW-6002) 20 or 40 mg once daily
16257202|NCT00957190|Drug|Dorzolamide 20 mg and Timolol 5 mg|Twice daily in the affected eye(s)
16257203|NCT00957177|Drug|Pregabalin|300mg pregabalin orally 1 hour before operation
16257204|NCT00957177|Drug|Placebo|Placebo
16257205|NCT00957164|Behavioral|Brief Prolonged Exposure Protocol|The PTSD treatment used in this study is an adaptation of a brief Prolonged Exposure treatment protocol for PTSD as illustrated in a 2005 paper published by Cigrang, Peterson, and Schobitz 54 in which a 4-session prolonged exposure treatment was used to address PTSD symptoms in three injured soldiers recently exposed to trauma. The authors found a 50+% decrease in PTSD symptoms after these four sessions. The present study will rely upon a similar brief PTSD intervention for treating chronic PTSD among trauma-exposed injured active duty service members. The PTSD intervention will be expanded into five sessions over 5 weeks to include an initial session for assessment and education on the co-morbidity of pain and PTSD. All PTSD treatment will be provided under the direct care or supervision of a Master Trained therapist in Prolonged Exposure.
16257206|NCT00957164|Behavioral|Chronic Pain Management Treatment|Pain treatment will involve five-sessions over 5 weeks of individual treatment protocol based on the existing chronic pain management program through the Clinical Health Psychology Service at Wilford Hall Medical Center. This treatment will involve covering the difference between chronic and acute pain, the role of cognitive, behavioral, and emotional variables in pain progression, and ways to manage these variables to prevent the development of chronic pain.
16257207|NCT00957164|Behavioral|Self-Care|participants randomized to either the Pain-only or PTSD-only groups will receive five sessions of pain- or PTSD-specific treatment followed by five sessions of self-care placebo over 5 weeks. The self-care module will be manualized for reliability and fidelity between providers and will involve 60-minute sessions covering various topics.
16257208|NCT00957151|Drug|Creon|
16257209|NCT00957125|Drug|Epirubicin|75 mg/m2 i.v. infusion, 30 min, cycle day 1, cycles 1-6.
16257210|NCT00957125|Drug|Docetaxel|75 mg/m2 i.v. infusion, 60 min, cycles day 1, cycle 1-6.
16257211|NCT00957125|Drug|Bevacizumab|15 mg/kg, i.v. infusion, 90 min, cycle day 1, cycles 3-6 if PR or SD after cycle 2.
16257212|NCT00957112|Procedure|acupuncture therapy|Patients undergo therapist-acupuncture with or without self-acupuncture
16257213|NCT00957112|Procedure|standard follow-up care|Patients receive standard care
16257214|NCT00957086|Drug|Nimotuzumab|Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.
16257215|NCT00957086|Drug|Placebo|Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.
16257216|NCT00957073|Device|Rheos® system|Implant procedure
16257217|NCT00957060|Drug|GLIMEPIRIDE (HOE490)|Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
16257218|NCT00957060|Drug|SITAGLIPTIN|Pharmaceutical form: 100 mg tablets Route of administration: oral
16257219|NCT00957047|Drug|eslicarbazepine acetate|oral tablets
16257220|NCT00957047|Drug|placebo|once daily placebo comparator
16257221|NCT00957047|Drug|ESL - Part II|Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.
16257222|NCT00957034|Drug|placebo|placebo patch
16257223|NCT00957034|Drug|testosterone|300 or 450 micrograms/day transdermal testosterone patch
16257224|NCT00957021|Device|Triathlon® PS Total Knee System|Triathlon® PS Total Knee system
16257225|NCT00957008|Behavioral|Group weight loss program|Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
16257226|NCT00957008|Other|Group weight loss program plus use of the Senseware Armband|Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning how to use the SenseWear Armband. They will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will receive a weight loss manual in addition to the group sessions and Armband.
16257227|NCT00957008|Device|Use of the senseware armband alone program|Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
16257228|NCT00956982|Drug|Pegylated interferon alpha-2b plus ribavirin|All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively
16257229|NCT00956969|Behavioral|Anger Awareness and Expression|Teaches patients to recognize, experience, and express emotions
16257230|NCT00956969|Behavioral|Relaxation Training|Teaches patients relaxation training
16257231|NCT00956956|Drug|PF-04455242|3, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing.
16257232|NCT00956956|Drug|Placebo|Placebo administered orally Q6 hours for 7 days of dosing.
16257233|NCT00956943|Drug|Nicoderm CQ transdermal nicotine|Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
16257234|NCT00956943|Drug|placebo|placebo patch
16257235|NCT00956930|Radiation|yttrium Y 90 glass microspheres|Patients undergo radioembolization.
16257236|NCT00956930|Drug|Doxorubicin|75mg fixed dose
16257237|NCT00956917|Device|Akern USA EFG|Impedance measurement device
16257238|NCT00956917|Device|RJL Impedance analyzer|Impedance analyzer
16257239|NCT00956904|Device|3-D TRUS navigation software during T-RALP|A new solution for guiding the surgeon in RALP is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot) has been developed. The research is a pilot clinical trial of the TRUS Robot and three-dimensional (3-D) navigation software to test its image-guidance ability of helping the surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of the images.
16257240|NCT00956865|Other|Voucher|Vouchers given to reimburse transportation
16257241|NCT00956865|Other|Telephone Call|Telephone reminder calls
16257242|NCT00956865|Other|Contact|Contact at senior center to encourage follow up
16257243|NCT00956839|Drug|Vitamin D3 (Cholecalciferol)|"Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose
~Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose
~Arm 3 - Oral vitamin D3 500 Units/day for 6 months"
16257244|NCT00956826|Device|Agit Vacuum|With an electrode and a regular vacuum device
16257245|NCT00956813|Dietary Supplement|flaxseed|Given orally
16257246|NCT00956813|Other|placebo|Given orally
16257247|NCT00956800|Other|Accu-Chek 360 software|Study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software.
16257248|NCT00956800|Other|Normal care|Control group will receive 5 routine office visits in one year
16257249|NCT00956787|Drug|AR-67 (20S)-7-t-Butyldimethylsilyl-10-hydroxycamptothecin)|Patients will receive AR-67 at an initial dose of 7.5 mg/m2 IV over 1 hour daily for 5 days. In patients with stable disease, treatment may continue for up to a total of 12 courses of therapy; about 1 to 2 years.
16257250|NCT00956774|Procedure|HSG with acorn-tipped cannula|Use of acorn-tipped cannula for HSG to evaluate tubal patency
16257251|NCT00956774|Procedure|HSG with cervical vacuum cup|cup placed over cervix to create vacuum pressure.
16257252|NCT00956774|Procedure|HSG with balloon catheter|balloon inserted via catheter into cervic for dilation.
16257253|NCT00956761|Biological|Seasonal Influenza Vaccine (MF59C.1)|1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010
16257254|NCT00956748|Drug|Ciprodex|Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.
16257255|NCT00956748|Drug|Ciprodex and 2% NAC|Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.
16257256|NCT00956735|Other|Pistachio|3.0 oz (2 servings) of roasted and salted or unsalted pistachios
16257257|NCT00956722|Drug|Bovine Colostrum Powder|Bovine Colostrum Powder (Biogard)
16257258|NCT00956709|Drug|levobupivacaïne 0,5 %|20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
16257259|NCT00956709|Drug|ropivacaïne 0,5 %|20mL de ropivacaïne 0,5 %
16257260|NCT00956696|Drug|topiramate|oral, daily dose or twice daily dose, total daily dose 25-200mg per day duration: 16 weeks
16257261|NCT00956683|Procedure|Ultrasound Guided Infraclavicular Nerve Block|Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block.
16257262|NCT00956683|Procedure|Dual-Endpoint nerve stimulation|Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block.
16257263|NCT00956670|Other|Quality-of-Life Assessment|Ancillary studies
16257264|NCT00956670|Other|Questionnaire Administration|Ancillary studies
16257265|NCT00956670|Procedure|Study of High Risk Factors|Undergo lymphedema assessment
16257266|NCT00956670|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16257267|NCT00956670|Procedure|Therapeutic Laparoscopic Surgery|Undergo surgery
16257268|NCT00956670|Procedure|Therapeutic Lymphadenectomy|Undergo lymphadenectomy
16257269|NCT00956657|Behavioral|Psychological Intervention Session|One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style.
16257270|NCT00956644|Drug|irbesartan/amlodipine|Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
16257271|NCT00956644|Drug|amlodipine|Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
16257272|NCT00956631|Procedure|Interlaminar Decompression|The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
16257273|NCT00956605|Behavioral|Computer attention training systems for children with ADHD|Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants
16257274|NCT00956592|Device|CMAC video laryngoscope|Intubation utilizing the assistance of video enhancement
16257275|NCT00956592|Device|Macintosh laryngoscope|Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
16257276|NCT00956566|Behavioral|dietary intervention|dietary counseling, group teaching
16257277|NCT00956553|Biological|Cervarix|Three doses of Cervarix at month 0, 1 and 6.
16257278|NCT00956553|Biological|Gardasil|Three doses of Gardasil at month 0, 1 and 6.
16257279|NCT00956540|Procedure|Deflating tracheal cuff|Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.
16257280|NCT00956540|Procedure|Deflating tracheal cuff 2|Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
16257388|NCT00955799|Drug|Neramexane mesylate|Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
16257281|NCT00956527|Behavioral|Modified traditional martial arts training|"Twice weekly hour-long training sessions. Classes will not vary significantly from those classes already taught at the karate school, with the following exceptions: 1) the focus of training will be primarily on the non-combative components of martial arts training, 2) there will be a higher instructor to student ratio, 3) belt advancement will be based not only on mastery of karate techniques, but also on achieving the predetermined goals as described above, and 4) weekly 5-10 minute talks will be delivered by the primary instructor and will consist of concepts relevant to substance abuse treatment (including both issues directly relating to drug use and the common skills deficits seen in at risk youth) and how these issues relate to martial arts concepts."
16257282|NCT00956514|Device|Transcranial Magnetic Stimulation|Neurophysiologic Predictors of Outcome with rTMS Treatment of Major Depressive Disorder
16257283|NCT00956488|Behavioral|Treadmill Exercise|The intervention will consist of 30 minutes of exercise, performed 3 times per week for 8 weeks (24 sessions). Patient will walk on a treadmill with up to 40% of their body weight supported by a body weight support system with an overhead harness. The training session duration will be 60 minutes consisting of six intervals of 5 minutes exercise, interspersed with 6 intervals of 5 minutes rest to avoid overwork weakness and fatigue. Five minute exercise intervals should be sufficient for patients to reach a steady state. Patients will build up their endurance to this training level at their own pace as tolerated. Walking speed will be determined as tolerated by each patient. Exercise intensity will be guided by each patient's own perception of exertion, but not to exceed level 12-13 (mild to moderate) on the modified Borg perceived exertion scale, and by oxygen saturation (Sa O2) ≥ 90% monitor by handheld pulse Oximeter.
16257284|NCT00956475|Behavioral|telephone-based intervention|Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
16257285|NCT00956475|Other|questionnaire administration|Patients are assessed in a telephone interview using a brief demographic and clinical data form. Patients then undergo quality-of-life assessment by the Cancer Patient/Cancer Survivor Version questionnaire via telephone.
16257286|NCT00956475|Procedure|assessment of therapy complications|questionnaire via telephone
16257287|NCT00956475|Procedure|fatigue assessment and management|questionnaire via telephone
16257288|NCT00956475|Procedure|psychosocial assessment and care|questionnaire via telephone
16257289|NCT00956475|Procedure|quality-of-life assessment|questionnaire via telephone
16257290|NCT00956462|Drug|Ketorolac (NSAID) versus Dexamethasone (steroid)|Topical NSAID versus topical steroid after implantation of glaucoma drainage device
16257291|NCT00956449|Biological|Seasonal Influenza Vaccine|1 dose of Influenza Vaccine Surface Antigen, Inactivated
16257292|NCT00956436|Drug|BIIB022|IV Q3W
16257293|NCT00956436|Drug|Sorafenib|Standard dosing of Sorafenib
16257294|NCT00956423|Behavioral|moderate-intensity aerobic and resistance training|Individuals will complete four days of aerobic exercise of moderate intensity (60% of maximal VO2, approximated from heart rate). Duration of aerobic activity will gradually increase from weeks 1 through 4 until 180 min of aerobic exercise at the prescribed intensity is performed each week. Following aerobic exercise on two days per week, moderate-intensity resistance training will be performed using eight different resistance machines. One set of 8-12 repetitions will be performed during weeks 1-4; from week 5-on, 2 sets of 8-12 repetitions will be performed.
16257295|NCT00956423|Behavioral|low-intensity stretching|Individuals will perform supervised whole-body flexibility exercises on two days per week. Two sets of each exercise will be performed, with the duration of each stretch gradually increasing from 15 sec to 30 sec. A total of 15-20 stretches, focusing on whole-body flexibility, will be performed.
16257296|NCT00956410|Biological|CAD106|
16257297|NCT00956397|Drug|Rifaximin|rifaximin 550 mg TID PO x 10 days
16257298|NCT00956397|Procedure|Lactulose Breath Test|Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).
16257299|NCT00956397|Drug|Placebo|placebo TID x 10 days
16257300|NCT00956384|Procedure|One-stage dermal matrix/implant procedure|One-stage breast reconstruction with dermal matrix and implant
16257301|NCT00956384|Procedure|Two-stage tissue expander/implant procedure|Two-stage breast reconstruction with tissue expander and implant
16257302|NCT00956371|Drug|ONO-7746|5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day
16257303|NCT00956371|Drug|ONO-7746|5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day
16257304|NCT00956345|Drug|nonacog beta pegol|Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
16257305|NCT00956345|Drug|nonacog beta pegol|Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
16257306|NCT00956345|Drug|nonacog beta pegol|Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)
16257307|NCT00956332|Biological|MultiGeneAngio|Low-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
16257308|NCT00956332|Biological|MultiGeneAngio|Intermediate-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
16257309|NCT00956319|Drug|Zolpidem MR|oral
16257310|NCT00956319|Drug|Estazolam|oral
16257311|NCT00956306|Drug|Udenafil|100mg Single Oral Dose of Udenafil
16257312|NCT00956293|Drug|Basiliximab|On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.
16257313|NCT00956293|Drug|Enteric Coated Mycophenolic Acid (MPA)|A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible.
16257314|NCT00956293|Drug|RAD001|Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL).
16257315|NCT00956293|Drug|Cyclosporin A (CsA)|Dosage was based according to blood level
16257389|NCT00955799|Drug|Placebo|Double-blind treatment period of 29 weeks placebo
16257316|NCT00956293|Drug|Corticosteroids|Dosage was administered according to local standards and administration was optional as per clinical need and the Investigators' discretion. Steroid withdrawal occurred after week 2 (pre-randomization).
16257317|NCT00956267|Drug|Letrozole|2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
16257318|NCT00956267|Procedure|Laparoscopic ovarian diathermy (LOD)|Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
16257319|NCT00956254|Drug|Fentanyl sublingual spray|Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.
16257320|NCT00956241|Procedure|j-pouch coloanal anastomosis|
16257321|NCT00956241|Procedure|side-to-end coloanal anastomosis|
16257322|NCT00956228|Radiation|radioimmuniguided intenstiy modulated radiotherapy|All patients recieved 75.6 Gy in 42 fractions to the prostate and the region of the prostate which enhanced on prostascint scan was simaltaneously boosted to a total dose of 82 Gy
16257323|NCT00956215|Drug|Aprepitant|80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
16257324|NCT00956215|Drug|Aprepitant placebo|80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.
16257325|NCT00956202|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
16257326|NCT00956202|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)|0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
16257327|NCT00956202|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)|0.5 mL, Intramuscular on Day 0 and day 21
16257328|NCT00956189|Drug|amisulpride|Amisulpride dosage was increased from 200 up to a maximum of 1000 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
16257329|NCT00956189|Drug|aripiprazole|Aripiprazole dosage was increased from 5-7.5 up to a maximum of 30 mg/day and the dosage of their previous antipsychotics can be tapered gradually under stable clinical condition.
16257330|NCT00956176|Drug|Cidofovir|Single dose of 5 mg/kg administered in 100 ml of normal saline solution through a foley catheter to bladder. The catheter will be clamped for 2 hours to keep the drug in bladder.
16257331|NCT00956163|Procedure|magnetic resonance imaging|Undergo whole-body MRI
16257332|NCT00956163|Radiation|fluorine F 18 sodium fluoride|Undergo fluorine F 18 sodium fluoride PET/CT scan
16257333|NCT00956163|Procedure|positron emission tomography|Undergo fluorine F 18 sodium fluoride PET/CT scan
16257334|NCT00956163|Procedure|computed tomography|Undergo fluorine F 18 sodium fluoride PET/CT scan
16257335|NCT00956163|Radiation|technetium Tc 99m methylene diphosphonate|Undergo technetium Tc 99m methylene diphosphonate bone scan
16257336|NCT00956163|Other|laboratory biomarker analysis|Correlative studies
16257337|NCT00956150|Procedure|Lactulose Breath Test|Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).
16257338|NCT00956150|Drug|Rifaximin|Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
16257339|NCT00956150|Drug|Placebo|Placebo TID PO x 10 days
16257340|NCT00956137|Procedure|Ultrasound guidance|ultrasound imaging
16257341|NCT00956137|Procedure|Manual palpation|Manual Palpation of vertebra
16257342|NCT00956111|Biological|split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose|100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
16257343|NCT00956111|Biological|split-virion, adjuvanted H1N1 vaccine of 15 μg per dose|100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
16257344|NCT00956111|Biological|split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose|100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
16257345|NCT00956111|Biological|split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose|100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
16257346|NCT00956111|Biological|whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose|100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart.
16257347|NCT00956111|Biological|whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose|100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine
16257348|NCT00956111|Biological|placebo control|100 adults were assigned to receive 2 doses of placebo 21 days apart.
16257349|NCT00956098|Drug|oltipraz|60mg bid 90mg qd
16257350|NCT00956098|Drug|placebo|
16257351|NCT00956085|Drug|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
16257352|NCT00956072|Drug|imatinib mesylate|Patients receive imatinib mesylate
16257353|NCT00956072|Procedure|therapeutic conventional surgery|Patients undergo surgery
16257354|NCT00956059|Drug|prednisone, FK506, MMF|1.in the initial 3 months，prednisone dosage is 30mg per day；in the following 4~6 months，prednisone dose decreased to 20mg per day，then tapered gradually to 10mg per day；2.the initial dosage of FK506 is 0.2mg/kg/d, twice per day，the maintenance dosage is adjust to the serum concentration of FK506 (is maintained at the level of 6~10μg/L)；3. the initial dosage of MMF is 1.0g, twice per day，then reduce to 0.75 g, twice per day after 3 months
16257355|NCT00956059|Drug|prednisone|In the initial 16~24 weeks，prednisone is given at full dose of 1mg/kg/d，then prednisone is tapered gradually，the whole course of treatment is 52 weeks
16257495|NCT00955071|Other|Exercise: HVLI|high volume, low intensity
16257356|NCT00956046|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
16257357|NCT00956046|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)|0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
16257358|NCT00956046|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)|0.5 mL, Intramuscular on Day 0 and Day 21
16257359|NCT00956020|Biological|Platelet rich fibrin matrix|Single treatment with platelet rich fibrin matrix
16257360|NCT00956007|Biological|cetuximab|Given IV
16257361|NCT00956007|Radiation|intensity-modulated radiation therapy|Patients undergo radiotherapy.
16257362|NCT00955994|Drug|asimadoline|
16257363|NCT00955981|Drug|RDEA594|Uricosuric agent for the treatment of gout
16257364|NCT00955981|Drug|Placebo|Matching placebo
16257365|NCT00955968|Drug|Highly active antiretroviral therapy (HAART)|"A combination of three or more HIV medications belonging to two or more drug classes.
~The preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant."
16257366|NCT00955955|Other|6(S)-5-MTHF(Deplin)|Deplin is a medical food. Patients will take 15 mg/day of deplin.
16257367|NCT00955955|Other|Placebo|Inactive substance
16257368|NCT00955942|Dietary Supplement|flaxseed|Given orally
16257369|NCT00955942|Other|placebo|Given orally
16257370|NCT00955929|Drug|Placebo QHS and sildenafil and questionnaires|Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
16257371|NCT00955929|Drug|Sildenafil and questionnaire|Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
16257372|NCT00955929|Drug|Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires|Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
16257373|NCT00955916|Drug|CLAG Regimen|The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine.
16257374|NCT00955916|Drug|Gleevec®|Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
16257375|NCT00955903|Behavioral|Exercise|Participants will participate in supervised exercise sessions
16257376|NCT00955903|Behavioral|Reduced Calorie Diet|Participants will follow a reduced calorie diet
16257377|NCT00955903|Behavioral|Weight Maintenance Diet|Participants will follow a weight maintenance diet
16257378|NCT00955890|Drug|Dexrazoxane hydrochloride|pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
16257379|NCT00955890|Drug|Dexrazoxane hydrochloride|pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
16257380|NCT00955877|Drug|Extended-release Epidural morphine (EREM) 80|After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
16257381|NCT00955877|Drug|Extended-release Epidural Morphine (EREM) 120|After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
16257382|NCT00955877|Drug|Control: Saline|After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
16257383|NCT00955851|Other|Pre and post vaccination titers|Titers will be obtained pre vaccination and 4 weeks post vaccination
16257384|NCT00955838|Other|Rehabilitation technique|12 therapy session
16257385|NCT00955825|Drug|300 IR|300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
16257386|NCT00955825|Drug|Placebo|Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
16257387|NCT00955812|Drug|OPB-31121|50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.
16257390|NCT00955786|Drug|CX-3543|Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
16257391|NCT00955773|Drug|GSK1120212 plus everolimus|Dose escalation will begin at low doses of GSK1120212 and everolimus, then gradually increase in future cohorts. Dose escalation will continue until a recommended combination dose is identified. The recommended combination dose will be used to treat pancreatic and lung cancer patients in later groups in this study.
16257392|NCT00955760|Drug|Neramexane|Drug-Drug Interaction Study
16257393|NCT00955747|Drug|Tagatose|powder; 15 grams three times daily; one year
16257394|NCT00955747|Drug|Sugar Substitute Splenda|1.5 g powder tid
16257395|NCT00955734|Other|Early motion|One set of patients will begin wrist motion at 1 week after surgery.
16257396|NCT00955734|Other|Immobilization|This set of patients will be casted for 6 weeks after surgery.
16257397|NCT00955721|Drug|Gemcitabine|Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
16257398|NCT00955721|Drug|Oxaliplatin|Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
16257399|NCT00955721|Drug|Sorafenib|Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.
16257400|NCT00955708|Device|ACUITY Spiral Left Ventricular Lead|The implant of the ACUITY Spiral Lead
16257401|NCT00955695|Drug|erlotinib hydrochloride|
16257402|NCT00955695|Drug|gefitinib|
16257403|NCT00955695|Other|questionnaire administration|
16257404|NCT00955695|Procedure|quality-of-life assessment|
16257405|NCT00955695|Radiation|whole-brain radiation therapy|
16257406|NCT00955682|Biological|Meningococcal vaccine GSK134612|One intramuscular dose (Booster)
16257407|NCT00955682|Biological|Meningitec™|One intramuscular dose (Booster)
16257408|NCT00955669|Biological|Symptoms and Objective Examination|5.0*108~5.0*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
16257409|NCT00955643|Other|oxygen|
16257410|NCT00955643|Other|other|
16257411|NCT00955630|Drug|ranibizumab|3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
16257412|NCT00955630|Drug|ranibizumab|prn injections of ranibizumab throughout the study
16257413|NCT00955617|Other|Contrast-enhanced MRA - Imaging examination|Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
16257414|NCT00955604|Drug|Group R+AD Rasagiline + Antidepressant|Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days
16257415|NCT00955604|Drug|Group R Rasagiline|At least 2 months of rasagiline
16257416|NCT00955604|Drug|Group AD Anti-PD + Antidepressant|An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.
16257417|NCT00955591|Other|Papanicolaou test|
16257418|NCT00955578|Procedure|Punch Biopsy|5-6 punch biopsies of affected areas
16257419|NCT00955565|Procedure|Navigated|Subjects receive receive computer assisted placement of the sacroiliac screws. The computer assisted placement will be performed by using the BrainLab Vector Vision®Trauma Navigation Software. Two approaches will be used, the 2D navigation and 3D navigation.
16257420|NCT00955565|Procedure|Conventional|Subjects receive standard fluoroscopic placement of the sacroiliac screw.
16257421|NCT00955552|Drug|Glucosamine sulphate and chondroitin sulphate association|glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
16257422|NCT00955552|Drug|Condroflex (Zodiac)|oral capsule of glucosamine sulphate 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
16257423|NCT00955539|Device|AV-optimization followed by AV- and VV-optimization|Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.
16257424|NCT00955539|Device|AV- and VV-optimization followed by AV-optimization only.|Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months.
16257425|NCT00955526|Drug|Istradefylline|20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
16257426|NCT00955526|Drug|Istradefylline|40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
16257427|NCT00955526|Drug|Placebo|Two placebo tablets once daily for 12 weeks
16257428|NCT00955513|Drug|diclofenac diethylamine gel 2.32%|diclofenac diethylamine gel 2.32% twice a day
16257429|NCT00955513|Drug|diclofenac diethylamine gel 2.32%|diclofenac diethylamine gel 2.32% three times a day
16257430|NCT00955513|Drug|Placebo|Placebo
16257431|NCT00955500|Dietary Supplement|Branched-chain amino acids|30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily
16257432|NCT00955500|Dietary Supplement|Maltodextrin|30 grams of oral maltodextrin daily
16257433|NCT00955487|Drug|Inhaled Nitric Oxide (iNO)|iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
16257434|NCT00955487|Drug|Nitrogen (placebo)|Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
16257435|NCT00955474|Drug|Quetiapine|Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
16257436|NCT00955474|Drug|escitalopram|"Active comparator arm:
~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
16257437|NCT00955474|Drug|Sertraline|"Active comparator arm:
~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
16257438|NCT00955474|Drug|Citalopram|"Active comparator arm:
~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m."
16257439|NCT00955461|Procedure|RevLite laser treatment|Electro-optic Q-Switched Nd: YAG Laser treatment
16257440|NCT00955461|Procedure|Fractionated Laser treatment|
16257441|NCT00955448|Device|SIS mesh (Cook Medical)|Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)
16257442|NCT00955448|Procedure|Anterior prolapse repair|Anterior prolapse repair will be conducted without using mesh reinforcement
16257443|NCT00955435|Other|Non-interventional|Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy per standard treatment. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.
16257444|NCT00955435|Genetic|Protein expression analysis|
16257445|NCT00955435|Genetic|Proteomic profiling|
16257446|NCT00955435|Other|Laboratory biomarker analysis|
16257447|NCT00955409|Biological|ACC-001(3µg) + QS21|Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
16257448|NCT00955409|Biological|ACC-001(10µg) + QS21|Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
16257449|NCT00955409|Biological|ACC-001(30µg) + QS21|Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
16257450|NCT00955396|Drug|GSK1014802|Tablets
16257451|NCT00955396|Drug|Placebo|Tablets
16257452|NCT00955383|Drug|GSK2190915|GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.
16257453|NCT00955383|Drug|Placebo|Matching placebo
16257454|NCT00955357|Drug|Lacosamide|"Oral Lacosamide:
~Subjects Titration Phase (6 Weeks):
~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
~Maintenance Phase (24 Weeks):
~200 mg tablet bid OR 150 mg tablet bid
~Taper Phase (1 - 3 Weeks):
~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
16257455|NCT00955344|Behavioral|eToolbox|Participants randomized to the Web-based intervention will be automatically routed to a URL that will contain the Web-based intervention.
16257456|NCT00955344|Behavioral|no link to eToolbox|Participants randomized to the Practice Improvement Module will not be automatically routed to a URL that will contain the Web-based intervention.
16257457|NCT00955318|Drug|KW-6500|Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state
16257458|NCT00955305|Biological|Bevacizumab|Given IV
16257459|NCT00955305|Drug|Carboplatin|Given IV
16257460|NCT00955305|Biological|Cixutumumab|Given IV
16257461|NCT00955305|Drug|Paclitaxel|Given IV
16257462|NCT00955292|Drug|Quarfloxin|Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks
16257463|NCT00955279|Drug|Placebo|Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
16257464|NCT00955279|Drug|Golimumab|Golimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
16257465|NCT00955279|Drug|Ustekinumab|Ustekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
16257466|NCT00955266|Drug|Calcium Chloride|Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
16257467|NCT00955266|Drug|Placebo|Normal saline, 50cc delivered over 5 minutes
16257468|NCT00955253|Drug|Guanfacine|2mg oral guanfacine (encapsulated)
16257469|NCT00955253|Drug|Placebo|placebo
16257470|NCT00955240|Biological|cetuximab|
16257471|NCT00955240|Drug|cisplatin|
16257472|NCT00955240|Drug|fluorouracil|
16257473|NCT00955240|Other|laboratory biomarker analysis|
16257474|NCT00955240|Radiation|radiation therapy|
16257475|NCT00955227|Dietary Supplement|Flax seed oil (ALA)|2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
16257476|NCT00955227|Drug|Ezetimibe|In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
16257477|NCT00955214|Device|TAXUS Liberté paclitaxel-eluting coronary stent system|diameter is 2.5mm
16257478|NCT00955201|Behavioral|Exercise|Structured aerobic exercise (treadmill).
16257479|NCT00955201|Behavioral|Exercise|Structured isokinetic strength exercise (dynameter).
16257480|NCT00955188|Other|computer-assisted intervention|
16257481|NCT00955188|Other|educational intervention|
16257482|NCT00955188|Other|medical chart review|
16257483|NCT00955175|Radiation|hypofractionated radiation therapy|Given 5 days a week for 20, 22, or 24 fractions
16257484|NCT00955162|Drug|Buprenorphine (Subutex)|Sublingual tablet
16257485|NCT00955162|Drug|Buprenorphine/naloxone (Suboxone)|Sublingual tablet
16257486|NCT00955149|Drug|Erlotinib (Tarceva)|Patients with PSC found to be positive for Trisomy 7 on biliary brushings will be treated with Erlotinib (Tarceva) at a dose of 25 mg or 50 mg by mouth once daily for 6 months.
16257487|NCT00955136|Device|Use of intermittent high MI impulses during echocardiogram|Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area. One vial of MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.
16257488|NCT00955110|Drug|Oxymorphone ER|15mg or 30mg
16257489|NCT00955110|Drug|Oxycodone CR|30mg or 60mg
16257490|NCT00955110|Drug|Placebo|The placebo was a sugar pill.
16257491|NCT00955110|Drug|Hydromorphone|8 mg
16257492|NCT00955097|Drug|Definity®|Definity® injections given both pre-ablation and post-ablation
16257493|NCT00955084|Drug|XL999|XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL
16257494|NCT00955071|Other|Exercise: LVLI|low volume, low intensity
16257496|NCT00955071|Other|Exercise: LVHI|low volume, high intensity
16257497|NCT00955058|Drug|OCP|Daily For 3 months
16257498|NCT00955045|Drug|istradefylline|
16257499|NCT00955032|Device|High-Frequency Repetitive Transcranial Magnetic Stimulation|In patients randomized to receive left prefrontal rTMS, each treatment will consist of 2000 stimuli (50 - 8-second trains of 40 stimuli at 5 Hz). We will administer rTMS trains every 30 seconds for 25 minutes. Stimulus intensity for the first and second trains will be 80 and 90% of MEP threshold, respectively.
16257500|NCT00955032|Device|Sham Repetitive Transcranial Magnetic Stimulation|Patients randomized to receive sham rTMS will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using Magstim Placebo 70 mm figure-of-8 shaped coils which produce discharge noise and vibration similar to a real 70 mm coil without stimulating the cerebral cortex. However, in addition to obvious coil discharge noise, rTMS also causes electrical stimulation of the scalp. We will simulate this experience by attaching surface electrodes underneath the sham coil and in contact with the scalp.
16257501|NCT00955006|Biological|VRC-HIVDNA-016-00-VP|Composed of six DNA plasmids in equal concentrations that encode Gag, Pol, and Nef from clade B (strains HXB2, NL4-3, NY5/BRU) and the HIV-1 Env glycoproteins from clade A (strain 92rw020), clade B (strains HXB2/BaL), and clade C (strain 97ZA012). Vaccine will be administered intramuscularly (IM) in the deltoid via needle-free Biojector.
16257502|NCT00955006|Biological|VRCHIVADV014-00-VP|A mixture of 4 recombinant serotype 5 adenoviral replication deficient vectors, each expressing HIV-1 proteins (clade B Gag-Pol fusion, clade A Env, clade B Env, clade C Env). Administered IM via needle and syringe.
16257503|NCT00954993|Drug|Vaniprevir|Period 1: Vaniprevir 600 mg twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg on Day 4. Period 2: Vaniprevir 300 mg twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg on Day 4. There was at least a 30-day (up to approximately 140-day) washout interval between periods 1 and 2.
16257504|NCT00954967|Behavioral|Lifestyle Counseling|The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.
16257505|NCT00954954|Device|Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)|Comparison of different types of knee prosthesis
16257506|NCT00954954|Device|High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)|Comparison of different types of knee prosthesis
16257507|NCT00954941|Drug|Ondansetron|8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
16257508|NCT00954941|Drug|Aprepitant|125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
16257509|NCT00954915|Biological|teplizumab|Cohorts 1-5: escalating doses of subcutaneously administered teplizumab; cohort 6: intravenous administration of maximum tolerated subcutaneous dose.
16257510|NCT00954902|Dietary Supplement|High Antioxidant Spice Blend|14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.
16257511|NCT00954902|Behavioral|Trier Psychological Stressor|This is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges.
16257512|NCT00954902|Other|Placebo antioxidant concentrate|Placebo capsules
16257513|NCT00954889|Drug|tamsulosin|Treatment: tamsulosin 0.2mg, 2T /day Posology: two 0.2 mg tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)
16257514|NCT00954889|Drug|placebo|(tamsulosin 0.2mg + placebo)/day Posology: two tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)
16257515|NCT00954876|Drug|capecitabine and cetuximab|"Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks
~Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks"
16257516|NCT00954837|Procedure|Fine needle aspiration|Classical needle biopsy techniques will be used, with patients lying on their backs with their necks in hyperextension. An initial ultrasound scan will be used to determine the site or sites at which the needle should be inserted. Following extensive disinfection of the skin of the neck, the needle will be inserted under ultrasound guidance. The needle will be moved gently backwards and forwards and displaced radially in a clockwise direction to recover cellular material by capillarity. In general, several (two or three) passages of the needle are required for a given nodule. It is possible to carry out FNA on up to three nodules in a single session. For each passage, a new, sterile, single-use needle will be used. The insertion of each needle will be preceded by an ultrasound scan.
16257517|NCT00954824|Biological|Endotoxin (LPS)|Single administration low-dose (3 ng/kg) endotoxin (LPS).
16257518|NCT00954811|Drug|300IU rec-LH|luteal alternate doses
16257519|NCT00954811|Drug|progesterone 600mg|luteal support
16257520|NCT00954798|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
16257521|NCT00954798|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
16257522|NCT00954798|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular on Day 0 and Day 21
16257523|NCT00954785|Device|Ankle brace|Sports Stirrup ankle brace (Aircast)
16257524|NCT00954785|Drug|Diclofenac 50 mg tds|In the diclofenac group, each subject will receive 50 mg diclofenac in the morning, at mid-day and in the evening
16257525|NCT00954785|Drug|Etoricoxib 120 mg mane|In the etoricoxib group, each subject will receive 120 mg etoricoxib in the morning, and placebo medication in the evening and at mid-day
16257526|NCT00954759|Procedure|Chiropractic treatment|
16257527|NCT00954759|Procedure|Visit without active treatment|The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not.
16257528|NCT00954733|Other|Arterial blood draw|One arterial blood draw
16257529|NCT00954720|Other|No Intervention|There is no intervention on this trial
16257530|NCT00954707|Drug|Clopidogrel & Aspirin, Prasugrel & Aspirin|This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of thienopyridine treatment in addition to aspirin.
16257531|NCT00954707|Drug|Placebo & Aspirin|This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
16257532|NCT00954694|Device|NuStep fitness apparatus|The NuStep is a mode of exercise that has recently been used in clinical settings to determine appropriate intensity recommendations and energy expenditures. The NuStep exercise implement provides simultaneous upper and lower body movement while in a seated position. The machine stimulates all major muscle groups while putting minimal strain on joints. Ten resistance settings are offered and the device is fully adjustable to accommodate users of varying sizes (NuStep, 2009).
16257533|NCT00954681|Drug|quetiapine|Quetiapine treatment from 25 mg daily to 300 mg twice daily
16257534|NCT00954668|Procedure|immediate angiography and revascularization|immediate angiography < 2 hours after randomization
16257535|NCT00954668|Procedure|early invasive angiography|early invasive angiography 12-72 h after randomization
16257536|NCT00954655|Genetic|mutation analysis|
16257537|NCT00954655|Genetic|polymorphism analysis|
16257538|NCT00954655|Other|laboratory biomarker analysis|
16257539|NCT00954642|Drug|bevacizumab|Intravenous repeating dose
16257540|NCT00954642|Drug|MNRP1685A|Escalating intravenous dose
16257541|NCT00954642|Drug|paclitaxel|Intravenous repeating dose
16257542|NCT00954629|Drug|strontium chloride hexahydrate|Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
16257543|NCT00954629|Drug|Placebo|Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.
16257544|NCT00954603|Drug|quetiapine|25-100 mg
16257545|NCT00954603|Drug|haloperidol|0.5-2 mg
16257546|NCT00954590|Drug|Dimebon (latrepirdine)|20 mg orally three times daily
16257547|NCT00954590|Drug|Placebo|Placebo orally three times daily
16257548|NCT00954577|Behavioral|Nutrition, health, and exercise education|The classroom intervention is part of the routine science curriculum and consists of 14 sessions taught by the investigators. Topics covered include the development of type 2 diabetes, nutrition education, exercise education, and overall healthy lifestyle education (both at home and in school). The intervention is offered in each year to all grades and to all students, regardless of whether or not they are enrolled in the study. The exercise intervention is optional and consists of 2-3 sessions per week of aerobic exercise (dancing) taught by pediatric trainers and offered in lieu of regular gym classes.
16257549|NCT00954564|Other|aromatase inhibition therapy - OBSERVATIONAL ONLY|Observational only - as prescribed
16257550|NCT00954564|Other|medical chart review|Observational only
16257551|NCT00954564|Other|questionnaire administration|Observational only
16257552|NCT00954564|Procedure|assessment of therapy complications|Observational only
16257553|NCT00954538|Drug|[18F]MK-3328|IV dose of ~150 megabecquerel (MBq) [18F]MK-3328
16257554|NCT00954525|Drug|Gemcitabine and Erlotinib|Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
16257555|NCT00954525|Dietary Supplement|Intravenous Vitamin C|50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
16257556|NCT00954512|Drug|Carboplatin|
16257557|NCT00954512|Drug|Epirubicin|
16257558|NCT00954512|Biological|Trastuzumab|
16257559|NCT00954512|Drug|Everolimus|
16257560|NCT00954512|Drug|Gemcitabine|
16257561|NCT00954512|Biological|Robatumumab|In Part 1, robatumumab was to be administered at 10 mg/kg, 15 mg/kg (for Regimens B and C), or 20 mg/kg together with the assigned standard treatment. For Part 2, robatumumab was to be administered at the dose selected during Part 1, based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK) and pharmacodynamic (PD) data.
16257562|NCT00954512|Biological|Cetuximab|
16257563|NCT00954512|Drug|Paclitaxel|
16257564|NCT00954512|Drug|Cisplatin|
16257565|NCT00954512|Drug|5-FU|
16257566|NCT00954512|Drug|Erlotinib|
16257567|NCT00954512|Drug|Irinotecan|
16257568|NCT00954512|Drug|Folinic Acid|
16257569|NCT00954499|Behavioral|Tactile stimulation added to Standard care|"Parent rubs the infant's skin near the injection site just before, during and after the injection.
~Fast injection technique without aspiration.
~Oral sucrose 2 minutes before first injection.
~Parent holds infant close."
16257570|NCT00954499|Behavioral|Standard care|"Fast injection technique without aspiration.
~Oral sucrose 2 minutes before first injection.
~Parent holds infant close."
16257571|NCT00954486|Drug|Epoetin alfa|Epoetin alfa will be administered at 10,000 units/week
16257572|NCT00954473|Other|laboratory biomarker analysis|Correlative studies
16257573|NCT00954460|Drug|velaglucerase alfa|up to 60 U/kg, every other week via intravenous infusion
16257574|NCT00954447|Drug|Placebo|Placebo, identical to Linagliptin tablet
16257575|NCT00954447|Drug|Linagliptin|intended final marketed dose
16257576|NCT00954434|Dietary Supplement|red wine|intake of red wine on a daily basis
16257577|NCT00954421|Device|Deep Brain Stimulation|Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
16257578|NCT00954395|Other|D-dimer|D-dimer is performed at the time of anticoagulation suspension. If above or below age and gender specific cut-offs, anticoagulation is stopped and D- dimer repeated after 15, 30, 60 and 90 days.
16257579|NCT00954369|Drug|[F-18]W372|"The individual doses of [F-18]W372 contain a maximum of 20 mCi for normal volunteers and 10 mCi for high probability AD subjects.
~The single IP dose is administered to the study subject immediately prior to the start of PET imaging."
16257580|NCT00954356|Drug|XPF-001|Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules)
16257581|NCT00954356|Drug|placebo|Single oral administration of 5 x 100 mg Placebo capsules.
16257582|NCT00954343|Procedure|Extracorporeal Shock Wave|
16257583|NCT00954343|Procedure|Extracorporeal Shock Wave|
16257584|NCT00954343|Procedure|Extracorporeal Shock Wave|
16257585|NCT00954343|Procedure|Extracorporeal Shock Wave|
16257586|NCT00954330|Procedure|lateral ligament surgery|. The disrupted FTA or/and FC and superficial retinacular structures were repaired by using absorbable sutures. In case of avulsion from the bone, the ligament was reapproximated with the use of sutures that were passed through 2.0 millimeter drill-holes in the bone.
16257587|NCT00954330|Device|functional treatment|Twenty-six patients randomized to the functional treatment received a functional light-weight orthotic device (Air-Cast ankle brace, Summit, New Jersey) for 3 weeks. Full weight bearing was allowed. The ankle brace allowed dorsi- and plantarflexion but it restricted inversion and eversion of the ankle.
16257588|NCT00954317|Procedure|epidural placed low|epidural placed low
16257589|NCT00954317|Procedure|high epidural|high epidural
16257590|NCT00954304|Drug|HM30181AK 1mg|HM30181AK 1mg tablet
16257591|NCT00954304|Drug|HM30181AK 5mg|HM30181AK 5mg tablet
16257592|NCT00954304|Drug|HM30181AK 15mg|HM30181AK 15mg tablet
16257593|NCT00954304|Drug|HM30181AK 60mg|HM30181AK 60mg tablet
16257594|NCT00954304|Drug|Loperamide 2mg|Loperamide 2mg capsule
16257595|NCT00954278|Drug|sorafenib|sorafenib (400mg or 600mg or 800mg) by mouth twice daily, for 28 days
16257596|NCT00954265|Drug|10000 IU urinary HCG|ovulation triggering
16257597|NCT00954265|Drug|250 mcg recombinant HCG|ovulation triggering
16257598|NCT00954252|Drug|CHF 5074|1x, oral capsule, single dose
16257599|NCT00954252|Drug|placebo|placebo, oral capsule, single dose
16257600|NCT00954252|Drug|CHF 5074|2x, oral capsule, single dose
16257601|NCT00954252|Drug|CHF 5074|4x, oral capsule, single dose
16257602|NCT00954252|Drug|CHF 5074|8x, oral capsule, single dose
16257603|NCT00954252|Drug|CHF 5074|16x, oral capsule, single dose
16257604|NCT00954252|Drug|CHF 5074|24x, oral capsule, single dose
16257605|NCT00954226|Drug|Erlotinib Hydrochloride|Given PO
16257606|NCT00954226|Other|Laboratory Biomarker Analysis|Correlative studies
16257607|NCT00954213|Behavioral|DIR/Floortime parent intervention|Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.
16257608|NCT00954200|Drug|ibuprofen|ibuprofen 10mg/kg syrup, single dose vs placebo
16257609|NCT00954200|Drug|ibuprofen|10mg/kg syrup - single dose
16257610|NCT00954187|Drug|Gabapentin|Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
16257611|NCT00954187|Drug|pregabalin|50 mg PO TID
16257612|NCT00954174|Drug|Carboplatin|Given IV
16257613|NCT00954174|Drug|Ifosfamide|Given IV
16257614|NCT00954174|Drug|Paclitaxel|Given IV
16257615|NCT00954174|Other|Quality-of-Life Assessment|Ancillary studies
16257616|NCT00954161|Other|Helping behaviour curriculum|The objective of the helping behaviour curriculum is to sensitise participants to develop a helping reaction, and to teach participants how to deal with barriers to helping. The helping behaviour curriculum is being taught in 2hours.
16257617|NCT00954161|Other|First aid only curriculum|Two hours training on first aid for alcohol and drug incidents
16257618|NCT00954148|Procedure|PET/CT|5 visits with PET/CT as only testing
16257619|NCT00954148|Procedure|NCCN recommendations for solid tumor post treatment|12-14 visits with exams, blood tests, CTs and PET/CT
16257620|NCT00954135|Drug|letrozolo+cyclophosphamide|Letrozole 2,5 mg/daily + metronomic cyclophosphamide 50 mg/daily for 6 months
16257621|NCT00954135|Drug|letrozolo+sorafenib+cyclophosphamide|"Letrozole (2,5 mg/daily) + metronomic cyclophosphamide (50 mg/daily) + Sorafenib (400 mg/bid/daily) for 6 months"
16257622|NCT00954122|Drug|Quetiapine XR (Seroquel XR)|Tablet, oral, once daily
16257623|NCT00954109|Behavioral|Exercise|daily exercise: supervised treadmill walking or cycle ergometry use
16257624|NCT00954096|Drug|transdermal nicotine patch (7mg)|A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.
16257625|NCT00954083|Behavioral|DIR/Floortime|Developmental, Individual-Difference, Relationship-Bases (DIR) focus more on relationship, social skills, and meaningful, spontaneous use of language and communication and integrated understand of human development
16257626|NCT00954083|Behavioral|Routine care|Routine care
16257627|NCT00954070|Device|Confocal endomicroscope (Pentax Model EC3870K)|The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.
16257628|NCT00954057|Drug|LIPO-102|intraorbital injection
16257629|NCT00954057|Drug|Placebo|intraorbital injection
16257630|NCT00954044|Behavioral|Randomized Exercise Intervention|"The Exercising Together training group will participate in 6 months of supervised, progressive partnered resistance exercise.
~Couples will participate in 2 exercise sessions a week for 6 months."
16257631|NCT00954044|Behavioral|Randomized Exercise Intervention|Couples will continue doing their usual daily activities for 6 months
16257632|NCT00954005|Drug|Therapy with Rituximab, Gemcitabine and Oxaliplatin|Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles
16257633|NCT00953979|Drug|kunxian capsule|The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.
16257634|NCT00953966|Other|Genetically modified potatoes|Starch from genetically modified potatoes
16257635|NCT00953953|Device|Phillips ultrasound system|The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
16257636|NCT00953940|Drug|Isotonic saline|Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery
16258482|NCT00947817|Other|ULTRASONOGRAPHY trans-esophageal and trans-thoracic , blood test and clinic test|
16257637|NCT00953927|Biological|MVA85A/AERAS-485|Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10^8 pfu.
16257638|NCT00953927|Biological|Candida Skin Test Antigen|1 test, administered once as a placebo control.
16257639|NCT00953914|Drug|Pyridostigmine|Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
16257640|NCT00953914|Drug|Placebo|If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
16257641|NCT00953901|Drug|Fresh Frozen Plasma Transfusion|
16257642|NCT00953888|Drug|AZD5069|Single dose of oral solution.
16257643|NCT00953888|Drug|Placebo|Single dose of oral solution.
16257644|NCT00953862|Drug|Atomoxetine|In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant at the optimized level for the final 6 weeks of the trial.
16257645|NCT00953849|Drug|Celecoxib|Celecoxib (400 mg twice daily)
16257646|NCT00953849|Drug|Calcitriol|3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)
16257647|NCT00953849|Drug|Celecoxib plus Calcitriol|3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
16257648|NCT00953810|Other|Educational training regarding heart failure|Like control plus one education training regarding heart failure aspects and management
16257649|NCT00953797|Device|Enhanced External Counterpulsation|A non-invasive method currently used for the treatment of ischemic coronary disease. During EECP therapy three compressive pneumatic cuffs are wrapped around the calves, lower thighs, and upper thighs. The cuffs inflate sequentially during diastole causing retrograde aortic flow, and increased venous return. At end diastole, the cuffs rapidly deflate resulting in unloading of the left ventricle and a decrease in systolic blood pressure.
16257650|NCT00953784|Procedure|standard operating management|As previously described
16257651|NCT00953771|Drug|Danazol|Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
16257652|NCT00953758|Drug|PF-04449913|Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles
16257653|NCT00953745|Drug|Escitalopram|All subjects will begin on escitalopram and placebo for 8 weeks
16257654|NCT00953745|Drug|Aripiprazole|Subjects who fail to respond to Escitalopram will continue on Escitalopram and augment with active Aripiprazole.
16257655|NCT00953745|Drug|Placebo Capsule|All subjects will begin on escitalopram and placebo capsule for 8 weeks.
16257656|NCT00953745|Drug|Placebo Tablet|After 8 weeks, subjects will be given a 2 week supply of escitalopram and placebo tablet.
16257657|NCT00953732|Drug|Lesion count|Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
16257658|NCT00953719|Device|36 mm ceramic head on a ceramic acetabular liner|Total hip replacement with a 36 mm ceramic head on a ceramic liner
16257659|NCT00953719|Device|28 mm ceramic head on a polyethylene acetabular liner|Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
16257660|NCT00953706|Drug|Ivacaftor|Tablet
16257661|NCT00953706|Drug|Placebo|Tablet
16257662|NCT00953693|Procedure|Biopsy|Skin biopsy
16257663|NCT00953680|Drug|losartan potassium (+) hydrochlorothiazide (HCTZ)|Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
16257664|NCT00953680|Drug|losartan potassium|Single dose losartan 100 mg tablet in one of two treatment periods.
16257665|NCT00953680|Drug|hydrochlorothiazide (HCTZ)|Single dose HCTZ 12.5 mg capsule in one of two treatment periods.
16257666|NCT00953667|Drug|Immediate Release Niacin, Extended Release Niacin, Endotoxin|Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
16257667|NCT00953654|Other|Strength Training|6 weeks of strength training exercise sessions involving leg press, leg curl, and leg extension exercises twice weekly at an intensity progressing from 50% to 75% of predicted one-repetition maximum across the 6 weeks of the trial.
16257668|NCT00953654|Other|Endurance Training|Six weeks of lower-body dynamic cycling exercise completed on an electronically-braked cycle ergometer twice weekly. The intervention will be matched to the strength training intervention on total work completed, total time actively engaged in exercise, a focus on leg muscles, and load (intensity) progression across the 6 week training protocol.
16257669|NCT00953641|Drug|Misoprostol|Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure
16257670|NCT00953641|Drug|Placebo|Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy
16257671|NCT00953628|Drug|10000 IU urinary HCG|bolus 10000 units for ovulation triggering
16257672|NCT00953628|Drug|250 mcg recombinant HCG|bolus 250 mcg for ovulation triggering in IVF patients
16257673|NCT00953615|Drug|Thalidomide|Titrate to 400 mg daily for 6 months
16257674|NCT00953602|Other|Genetically modified potato|Genetically modified potato
16257675|NCT00953589|Drug|ribavirin|Ribavirin - oral administration Subjects with body weight < 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight > 105 kg: 1400 mg/day
16257676|NCT00953576|Drug|ketoconazole|
16257677|NCT00953576|Drug|hydrocortisone|
16257678|NCT00953576|Drug|dutasteride|
16257679|NCT00953576|Drug|lapatinib|
16257680|NCT00953563|Device|Unite Biomatrix|collagen based, decellularized equine pericardial dressing for skin surface wounds
16257681|NCT00953550|Drug|Rocuronium-Sugammadex|Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
16257682|NCT00953550|Drug|Succinylcholine|1 mg/kg
16257683|NCT00953537|Drug|capecitabine|
16257684|NCT00953537|Other|laboratory biomarker analysis|
16257685|NCT00953537|Other|pharmacological study|
16257686|NCT00953524|Biological|Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)|0.5 mL, Intramuscular on Day 0 and on Day 21
16257687|NCT00953524|Biological|Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)|0.5 mL, Intramuscular on Day 0 and Day 21
16257688|NCT00953524|Biological|Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)|0.5 mL, Intramuscular on Day 0 and day 21
16257689|NCT00953524|Biological|Normal saline solution (placebo)|0.5 mL, Intramuscular on Day 0 and Day 21
16257690|NCT00953511|Genetic|ERCC1 pathways analysis|The gene polymorphism of ERCC1 rs11615 and the pathways of ERRC1 will be analyzed in endoscopic tumor biopsies as well as in normal tissues prior to therapy. The results will be compared with histopathologic response after neoadjuvant therapy.
16257691|NCT00953498|Drug|pioglitazone|After randomization, patients will be treated by pioglitazone or rosiglitazone
16257692|NCT00953498|Drug|rosiglitazone|treatment with rosiglitazone at a dose between 4mg and 8 mg/day
16257693|NCT00953485|Biological|Allogeneic Mesenchymal Stem Cells (AlloMSC)|Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
16257694|NCT00953472|Drug|brain natriuretic peptide|start 10 mcg/kg (2 participants), 7 mcg/kg (2 participants), 5 mcg/kg (2 participants) and 2 mcg/kg (2 participants)
16257695|NCT00953472|Other|no-added salt diet|instruction to reduce salt for one week prior to study
16257696|NCT00953459|Drug|sunitinib malate|
16257697|NCT00953459|Other|laboratory biomarker analysis|
16257698|NCT00953459|Radiation|fludeoxyglucose F 18|
16257699|NCT00953446|Procedure|Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging|Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment
16257700|NCT00953433|Device|Endoflex tube|Size decided upon gender.
16257701|NCT00953433|Device|Polyvinyl chloride endotracheal tube with a stylet|Size decided upon gender.
16257702|NCT00953420|Drug|Docetaxel|60 mg/m2 IV on Day 1
16257703|NCT00953420|Drug|Carboplatin|Target AUC of 5 (mg/ml x min) on Day 1
16257704|NCT00953420|Drug|Dexamethasone|5 mg/m2/dose (max of 8 mg/dose) po q hs on Day 0, and q am and hs on Day 1
16257705|NCT00953420|Biological|EBV-specific cytotoxic T lymphocytes|1 x 10e8 cells/m2 IV over 1 to 5 min
16257706|NCT00953420|Biological|G-CSF or Peg-GCSF|If needed per dose modification guidelines: Peg-GCSF 0.1 mg/kg ≤ 45 kg; 6 mg for > 45 kg subcutaneous on Day 2 or GCSF 5 mcg/kg/day (max of 600 mcg) subcutaneous to start 24 hours after carboplatin administration until ANC > 2500 cells/ul x 2 days after nadir.
16257707|NCT00953407|Device|Nelfilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16257708|NCT00953407|Device|Narafilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16257709|NCT00953407|Device|Etafilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16257710|NCT00953407|Device|Omafilcon A contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16257711|NCT00953407|Device|Hilafilcon B contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16257712|NCT00953394|Drug|continuous 5 fluouracil infusion plus long-acting octreotide|long-acting octreotide acetate at a dose of 20 mg was administered intramuscularly every 4 weeks. 5fluorouracil was given as a protracted continuous infusion without interruption at a daily dose of 200 mg/m2 of body-surface area through an elastomeric pump connected to a central venous access.
16257713|NCT00953381|Drug|5 mg ilaprazole|One 5-mg ilaprazole tablet (Livzon Pharm Group Inc., China) together with three placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16257714|NCT00953381|Drug|10 mg ilaprazole|Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with two placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16257715|NCT00953381|Drug|20 mg ilaprazole|Four 5-mg ilaprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16257716|NCT00953381|Drug|20 mg omeprazole|One 20-mg omeprazole capsule (AstraZeneca, Losec) together with four placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
16257717|NCT00953368|Procedure|remote ischemic preconditioning|Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis
16257718|NCT00953355|Drug|Folate plus metformin|A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
16257719|NCT00953355|Drug|Placebo plus metformin|A six-month course of metformin (1700 mg daily) plus placebo
16257720|NCT00953342|Behavioral|Aerobic exercise|12 weeks of supervised exercise, 3 x week, 1 hour sessions
16257721|NCT00953342|Behavioral|Usual care|Standard medical care
16257722|NCT00953329|Drug|alefacept|Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.
16257723|NCT00953316|Other|Measure infant's jaw, record all information about car seat testing, and administer questionnaires.|Collect information about car seat testing of infants (until he/she transitions to a car seat), measure the infant's jaw during the first visit using a tape measure 18 different ways by Dr. Rhein or a trained research assistant, and complete a parent questionnaire about car bed use, previous testing of the infant in his/her car seat and information about the infant's home environment such as cigarette smoking, number of other children and daycare arrangements for the infant during the infant's first visit to the clinic. This short questionnaire asks information about car bed use, previous testing of your infant in his/her car seat and information about your home environment such as cigarette smoking, number of other children at your home and daycare arrangements for your infant.
16257724|NCT00953303|Drug|glucocorticoid|One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.
16257725|NCT00953303|Drug|standard care|The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.
16257726|NCT00953290|Device|Cutera Radio Frequency Device|Up to three treatments, one pass, dosage range of 15-60 kJ.
16258483|NCT00947791|Drug|ketamine|a single IV infusion of ketamine, IV 0.5 mg/kg
16257727|NCT00953277|Other|Processed Human Nerve Tissue Scaffold|Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
16257728|NCT00953264|Behavioral|lifestyle|lifestyle intervention, including diet, physical activity and behavioral changes
16257729|NCT00953225|Drug|vitamin D3|4,000 IU daily for one year
16257730|NCT00953225|Drug|Placebo daily for one year|Placebo
16257731|NCT00953212|Drug|beta blockers|metoprolol 25mg by mouth every 6 hours
16257732|NCT00953212|Drug|amiodarone|amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively
16257733|NCT00953212|Drug|ascorbic acid|ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
16257734|NCT00953199|Drug|Lidocaine Hydrochloride|1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
16257735|NCT00953199|Drug|Normal Saline|1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
16257736|NCT00953186|Device|hyperbaric air|air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
16257737|NCT00953186|Device|HBOT|100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
16257738|NCT00953173|Device|LAP-BAND AP® Adjustable Gastric Banding System|The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
16257739|NCT00953160|Device|Cutera Radio Frequency Device|Up to three treatments, one pass, dosage range of 15-60 kJ.
16257740|NCT00953147|Drug|Ciclesonide HFA 80 mcg|Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
16257741|NCT00953147|Drug|Ciclesonide HFA 160 mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
16257742|NCT00953147|Drug|Placebo|Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
16257743|NCT00953134|Dietary Supplement|Ferrous fumarate (iron)|60 mg of ferrous fumarate
16257744|NCT00953134|Dietary Supplement|folic acid|400 mcg folic acid
16257745|NCT00953121|Drug|bevacizumab and CPT-11 and Carboplatin|Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
16257746|NCT00953108|Drug|quetiapine|300 mg per day
16257747|NCT00953108|Drug|escitalopram|escitalopram 10 mg per day
16257748|NCT00953095|Behavioral|Joint Attention Intervention|Intervention in both conditions occurs once a week for 2 hours. Participants will be randomized to 1 of 2 interventions : (1) Caregiver Mediated Model (CMM):focuses on joint attention/engagement and involves individual meetings with the parents and children at their homes. Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input/ coaching from the interventionist) as they implement these techniques with their child. (2) Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services. Parents will receive information on child development each week, and will be able to ask questions and discuss the information. Parents meet in a group (without their children) in a community-based setting to receive the intervention.
16257749|NCT00953056|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|"Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.
~The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses."
16257750|NCT00953056|Biological|Comparator: Placebo|Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
16257751|NCT00953056|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|"Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
~The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses."
16257752|NCT00953056|Biological|Comparator: Placebo|Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
16257753|NCT00953043|Drug|lubiprostone|Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects
16257754|NCT00953043|Drug|Placebo|Placebo medication given for three days
16257755|NCT00953043|Other|Bowel preparation|Polyethylene glycol-based bowel preparation
16257756|NCT00953030|Behavioral|COACH|
16257757|NCT00953030|Behavioral|RealAge|
16257758|NCT00953017|Drug|Miralax (PEG 3350)|Miralax 255gm bottle
16257759|NCT00953017|Drug|Amitiza (Lubiprostone)|Amitiza 24mcg gelcap
16257760|NCT00953017|Drug|Dulcolax (Bisacodyl)|Bisacodyl 5mg tab x2
16257761|NCT00953017|Drug|Golytely (polyethylene glycol)|Golytely 1 gallon
16257762|NCT00953004|Dietary Supplement|fiber drink and fiber bread|fiber drink or fiber bread three times daily
16257763|NCT00952991|Drug|LAF237 = vildagliptin|
16257764|NCT00952978|Drug|10 mg ilaprazole|Two 5-mg ilaprazole tablets(Livzon Pharm Group Inc., China) together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16257765|NCT00952978|Drug|20 mg omeprazole|One 20-mg omeprazole capsule (AstraZeneca, Losec) together with two placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
16257766|NCT00952952|Drug|Mesalamine|
16257767|NCT00952939|Genetic|fluorescence in situ hybridization|At time of surgery
16257768|NCT00952939|Other|laboratory biomarker analysis|At time of surgery
16257769|NCT00952939|Procedure|fine-needle aspiration|At time of surgery
16257770|NCT00952939|Procedure|therapeutic conventional surgery|At time of surgery
16259721|NCT00939367|Drug|'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg|
16257771|NCT00952939|Other|Questionnaires|The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.
16257772|NCT00952913|Drug|Bosutinib|4 x 100-mg oral tablets, single dose
16257773|NCT00952913|Drug|Bosutinib|4 x 100-mg oral tablets, single dose
16257774|NCT00952913|Drug|Lansoprazole|2 x 30-mg oral tablets, single daily doses for 2 days
16257775|NCT00952900|Behavioral|Biobehavioral|6 sessions of Biobehavioral treatment modalities that include relaxation/biofeedback, stress management, and coping skills techniques.
16257776|NCT00952900|Behavioral|Active Coping/Attention Intervention|6 sessions of didactic educational techniques to expose patients to the causes of TMD, as well as introducing them to traditional treatment modalities for intervening with acute TMD problems.
16257777|NCT00952887|Biological|ACE-031|Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.
16257778|NCT00952887|Biological|Placebo|Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.
16257779|NCT00952861|Drug|Doxycycline|200 mg QD in 5 days
16257780|NCT00952861|Drug|Placebo (matching)|Placebo QD i 5 days
16257781|NCT00952848|Other|questionnaire administration|Pain Rating Score
16257782|NCT00952848|Other|Sensory Neuropathy Scale instrument|ECOG Common Toxicity Criteria for Sensory Neuropathy scale
16257783|NCT00952848|Other|Quality of Life instrument|Uniscale 0-100 scale global quality of life
16257784|NCT00952848|Device|MC5-A Scrambler device|Electrical stimulation for 60 minutes
16257785|NCT00952835|Other|regular treatment|regular treatment
16257786|NCT00952822|Biological|Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)|Subjects are randomized to receive an infusion of rAHF-PFM reconstituted in 2 mL sterile water for infusion (SWFI) followed (after a wash-out period) by rAHF-PFM reconstituted in 5 mL SWFI or in 5 mL then 2 mL SWFI(cross-over design). Each subject will receive 2 infusions.
16257787|NCT00952796|Drug|moxifloxacin|moxifloxacin 400mg once daily (IV form, 60minutes)
16257788|NCT00952796|Drug|ampicillin/sulbactam|ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)
16257789|NCT00952783|Drug|Lesion count|Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
16257790|NCT00952770|Procedure|transradial coronary intervention|percutaneous coronary intervention with transradial approach
16257791|NCT00952731|Drug|oral placebo|Oral placebo taken daily for 4-10 weeks.
16257792|NCT00952731|Drug|afimoxifene|2mg/breast applied daily in the form of a gel for 4-10 weeks.
16257793|NCT00952731|Drug|tamoxifen citrate|20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
16257794|NCT00952731|Drug|placebo gel|Placebo gel applied to breasts daily for 4-10 weeks.
16257795|NCT00952718|Other|Inspiratory muscle training|A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks.
16257796|NCT00952705|Biological|Q/LAIV-BFS (MEDI8662)|A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
16257797|NCT00952705|Biological|FluMist/B/Yamagata|FluMist/B/Yamagata - 0.2 mL dose at Day 0
16257798|NCT00952705|Biological|FluMist/B/Victoria|FluMist/B/Victoria - 0.2 mL dose at Day 0
16257799|NCT00952692|Biological|dHER2 + AS15 ASCI|"Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine.
~For each dose of 500µg of dHER2 + AS15 ASCI, two sterile glass vials will be supplied:
~One vial with the lyophilized preparation containing 500 ug of recombinant dHER2 antigen combined with the immunostimulant.
~One vial with liquid adjuvant diluent. The final dHER2 + AS15 ASCI for administration is obtained by reconstitution of the lyophilized preparation with the adjuvant diluents. A dHER2 + AS15 ASCI dose consists of 0.5 ml."
16257800|NCT00952692|Drug|Lapatinib|The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
16257801|NCT00952679|Device|Breast Lesion Localization Needles (interv)|needles to locate sln in CT monitor guided by CT
16257802|NCT00952666|Device|TRUS-RALRP|During surgery, and part of this research study, the ultrasound probe (TRUS) will be placed in the rectum. Then, using the mechanical support arm to hold and adjust the probe we will take ultrasound images during a portion of the robotic LRP surgery. The ultrasound probe will then be removed, and we will complete the LRP surgery as we usually do. We expect this to add approximately 20 minutes to the regular surgery time; the maximum added time will be 30 minutes.
16257803|NCT00952653|Drug|Desvenlafaxine Succinate Sustained Release|50 mg DVS SR tablet days 1-6, period 2 only.
16257804|NCT00952653|Drug|Midazolam|4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
16257805|NCT00952640|Dietary Supplement|vitamin A|high dose vitamin A, 200.000 IU
16257806|NCT00952627|Dietary Supplement|Pycnogenol|50 mg tablet, 200 mg/day, 4 tablets/day
16257807|NCT00952627|Dietary Supplement|Placebo|
16257808|NCT00952614|Device|fluocinolone acetonide (Retisert Implant, Bausch and Lomb)|sustained release device consisting of 0.59 mg of fluocinolone acetonide
16257809|NCT00952601|Dietary Supplement|Modified Atkins diet|Low carbohydrate diet
16257810|NCT00952588|Drug|AZD1152|1200 mg, iv, 7 day infusion
16257811|NCT00952588|Drug|LDAC|20 mg, sc, bd, 10 days
16257812|NCT00952575|Drug|polyclonal anti-D immunoglobulin|single injection of 300 µg
16257813|NCT00952575|Drug|monoclonal anti-D immunoglobulin|Comparison of different dosages of LFB-R593
16257814|NCT00952562|Dietary Supplement|cholecalciferol|Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
16257815|NCT00952562|Dietary Supplement|placebo|Empty capsules, 3 capsules per day for 16 weeks
16257816|NCT00952549|Procedure|Facial Yoga Toning Program|Patients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided.
16257817|NCT00952536|Dietary Supplement|Daily Juice Plus+ with vegetable & fruit & berry capsule|Daily Juice Plus+ with 2 vegetable & 2 fruit & 2 berry capsule
16257818|NCT00952536|Dietary Supplement|Daily Juice Plus+ vegetable & fruit & placebo capsule|Daily Juice Plus+ with vegetable & fruit & placebo capsule
16257819|NCT00952536|Dietary Supplement|Placebo in the form of 6 capsules|Daily Placebo in the form of 6 capsules (control group)
16257820|NCT00952523|Drug|Tretinoin Facial Gel|A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.
16257821|NCT00952523|Drug|Adapalene/Benzoyl Peroxide Facial Gel|A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
16257822|NCT00952497|Drug|Cisplatin, Capecitabine, Telatinib|Subjects will receive: Chemotherapy (capecitabine and cisplatin) and telatinib Capecitabine will be administered (1000 mg/m2) twice daily for 14 days followed by a 7-day rest period. Cisplatin (80 mg/m2) will be given as a 1-3 hour infusion once every 3 weeks. Telatinib (3 tablets) will be administered orally, twice daily as a continuous administration. After a maximum of 6 cycles of cisplatin, subjects continue with capecitabine and telatinib or monotherapy with either study drug,depending on the toxicity experienced by the subject, until disease progression.
16257823|NCT00952484|Biological|asfotase alfa|2 mg/kg subcutaneous injection three times per week for 6 months.
16257824|NCT00952484|Biological|asfotase alfa|3 mg/kg subcutaneous injection three times per week for 6 months.
16257825|NCT00952471|Other|Evidence Based Intervention to order set|The order set was altered to include evidence based care items
16257826|NCT00952458|Device|BIS monitoring|Neuromonitoring of depth of sedation with Bispectral Index
16257827|NCT00952445|Drug|T0903131 Besylate|Once daily, oral
16257828|NCT00952445|Drug|Placebo|Once daily, oral
16257829|NCT00952432|Drug|Carbamazepine|Carbamazepine 200mg, 1/2 tablet, TID for 1 month
16257830|NCT00952432|Procedure|Acupuncture|Acupuncture
16257831|NCT00952419|Biological|Monovalent Subvirion A/H1N1 Influenza vaccine|0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
16257832|NCT00952419|Biological|Monovalent Subvirion A/H1N1 Influenza vaccine|0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
16257833|NCT00952419|Biological|Normal saline solution (placebo)|0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
16257834|NCT00952406|Other|Survey|This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
16257835|NCT00952393|Drug|Pharmacokinetic|Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
16257836|NCT00952380|Drug|dalteparin|dalteparin subcutaneous injection
16257837|NCT00952367|Other|Nasopharyngeal swab|Nasopharyngeal swab
16257838|NCT00952341|Drug|aprepitant|Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
16257839|NCT00952341|Drug|Comparator: Placebo to aprepitant|Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
16257840|NCT00952341|Drug|dexamethasone|Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
16257841|NCT00952341|Drug|granisetron|Day 1: IV granisetron 3 mg prior to administration of cisplatin
16257842|NCT00952341|Drug|dexamethasone|Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
16257843|NCT00952328|Dietary Supplement|Nutramigen infant formula|Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.
16257844|NCT00952315|Device|Cyberwand|Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
16257845|NCT00952315|Device|Stonebreaker|Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
16257846|NCT00952315|Device|Lithoclast Select|Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
16257847|NCT00952302|Drug|Iron sucrose|Single intravenous infusion of iron 200 mg
16257848|NCT00952302|Drug|Normal saline|Single intravenous infusion of normal 0.9% saline 100 mls (as placebo)
16257849|NCT00952302|Procedure|Venesection|Isolvolaemic venesection of total 2 litres of blood - 500 mls each day for 4 days, replaced with normal saline.
16257850|NCT00952302|Drug|Iron sucrose|Two intravenous infusions, each of 200 mg of iron, separated by one day.
16257851|NCT00952302|Drug|Normal saline|Two intravenous infusions of normal 0.9% saline 100 mls (as placebo), separated by one day.
16257852|NCT00952289|Drug|Ruxolitinib|Ruxolitinib phosphate tablets 5 mg administered as oral doses.
16257853|NCT00952289|Drug|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug.
16257854|NCT00952276|Biological|Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant|0.5 mL, Intramuscular on Day 0
16257855|NCT00952276|Biological|Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant|0.5 mL, Intramuscular on Day 0
16257856|NCT00952276|Biological|Monovalent Subvirion A/H1N1 influenza vaccine|0.5 mL, Intramuscular on Day 0
16257857|NCT00952276|Biological|Monovalent Subvirion A/H1N1 influenza vaccine|0.5 mL, Intramuscular on Day 0
16257858|NCT00952276|Biological|Normal saline solution|0.5 mL, Intramuscular on Day 0
16257859|NCT00952263|Biological|MBL-HCV1|Single infusion of MBL-HCV1 at escalating doses as determined by cohort assignment: Cohort 1 @ 1 mg/kg, Cohort 2 @ 3 mg/kg, Cohort 3 @ 10 mg/kg, Cohort 4 @ 30 mg/kg, Cohort 5 @ 50 mg/kg.
16257860|NCT00952250|Behavioral|Targeted Feedback Reports|Sites randomized to this arm will receive specialized feedback summarizing their adherence to the guidelines and suggestions on ways to improve performance.
16257861|NCT00952250|Behavioral|Targeted Feedback Report|Report designed to target areas for local hospital-specific improvement
16257904|NCT00951899|Behavioral|Diet|Subjects were instructed to follow a weight maintenance diet (~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period.
16257862|NCT00952237|Drug|GM-CSF|"GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis.
~G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis."
16257863|NCT00952237|Drug|IL-2|"IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis.
~Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0).
~Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above"
16257864|NCT00952224|Other|magnetic resonance imaging|magnetic resonance imaging is used for prognosis assessment
16257865|NCT00952211|Device|CPAP|CPAP at therapeutic pressure during nighttime
16257866|NCT00952211|Device|CPAP at sub-therapeutic pressure|CPAP delivered at sub-therapeutic pressure at nighttime
16257867|NCT00952198|Drug|ARRY-403, glucokinase activator; oral|multiple dose, escalating
16257868|NCT00952198|Drug|Placebo; oral|matching placebo
16257869|NCT00952185|Other|cytology specimen collection procedure|
16257870|NCT00952185|Other|fluorescent antibody technique|
16257871|NCT00952185|Procedure|assessment of therapy complications|
16257872|NCT00952172|Behavioral|stair stepping exercise|Stair stepping exercise performed at home daily for eight weeks
16257873|NCT00952159|Biological|Monitoring seric concentrations of O-demethyl-tramadol and tramadol|The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.
16257874|NCT00952146|Procedure|Transgastric peritoneoscopy (NOTES)|Under general anesthesia an endoscope will be passed through the gastric wall into the peritoneal cavity to examine the peritoneal cavity. At the withdrawal of the endoscope, the gastric access in the stomach wall will be closed with T-tags.
16257875|NCT00952133|Drug|Palonosetron only|The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.
16257876|NCT00952133|Drug|Palonosetron with Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.
16257877|NCT00952120|Device|GSUC|Gauze-based wall suction negative pressure wound therapy
16257878|NCT00952120|Device|VAC|Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)
16257879|NCT00952107|Device|FLARE imaging system|Testing of operation of imaging system
16257880|NCT00952094|Drug|KRN1493|KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
16257881|NCT00952081|Drug|Clevidipine|Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g. labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
16257882|NCT00952068|Drug|Tramadol Contramid® OAD 200mg|1 Tramadol Contramid® OAD 200mg tablet daily.
16257883|NCT00952042|Other|Heavy slow resistance training|Heel-raises. 12-6RM. each contraction performed slowly. three times weekly for 12 weeks
16257884|NCT00952042|Other|Eccentric resistance training|Eccentric heel-raises. 3 x 15 reps performed twice daily for 12 wks.
16257885|NCT00952029|Biological|bevacizumab|
16257886|NCT00952029|Drug|FOLFIRI regimen|
16257887|NCT00952029|Drug|fluorouracil|
16257888|NCT00952029|Drug|irinotecan hydrochloride|
16257889|NCT00952029|Drug|leucovorin calcium|
16257890|NCT00952016|Drug|Methotrexate|study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.
16257891|NCT00952003|Drug|Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel|
16257892|NCT00951990|Behavioral|Ergometer Cycling|Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed three times a week for a time period of at least three weeks. The resistance of the ergometer was set to a minimum (for example 30 Watts). Physical therapists were informed to pay special attention, that the height of the saddle is set so that the forefoot reaches the pedal with the knee in extension.
16257893|NCT00951990|Behavioral|No ergometer cycling|Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery
16257894|NCT00951964|Drug|Polyphenon E before Placebo|patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
16257895|NCT00951964|Drug|placebo before treatment|patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment
16257896|NCT00951951|Procedure|Anterior Approach|Anterior Minimal Invasive Surgery (AMIS)
16257897|NCT00951951|Procedure|Posterior Approach|
16257898|NCT00951925|Other|Bone Marrow Aspirate Draw|5cc of Bone Marrow Aspirate will be drawn
16257899|NCT00951912|Dietary Supplement|Placebo|10g soy protein isolated per day
16257900|NCT00951912|Dietary Supplement|Daidzein|50mg daidzein +10g soy protein isolated per day
16257901|NCT00951912|Dietary Supplement|Genistein|50mg genistein +10g soy protein isolated per day
16257902|NCT00951899|Drug|Colesevelam|Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.
16257903|NCT00951899|Other|Placebo|Three placebo tablets matching the active drug colesevelam in appearance, taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.
16257905|NCT00951899|Drug|Metformin|Subjects continued to take their pre-study therapeutic doses of metformin (Metformin 500mg tablets taken by mouth twice daily for a total daily dose of 1000 to 2000 mg) through the 12 week study period.
16257906|NCT00951873|Drug|activated recombinant human factor VII, long acting|Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
16257907|NCT00951873|Drug|placebo|Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
16257908|NCT00951873|Drug|activated recombinant human factor VII, long acting|Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).
16257909|NCT00951860|Other|Autonomic Nervous System activity|Autonomic activity measured at birth and at 6, 12, 18 and 24 months is represented by time-domain indices (SDNN index, SDANN, pNN50) and frequency- domain indices(PTOT, VLF, LF, HF, ratio LF / HF, LFnu, HFnu), which reflect the short-term variability (parasympathetic branch) and medium term (ortho and parasympathetic branch) of the vegetative balance. This subtle technical assessment of autonomic functioning has been validated in the literature for two decades
16257910|NCT00951847|Drug|oxcarbazepine 300 mg/5 mL oral suspension|
16257911|NCT00951834|Drug|Epigallocatechin-Gallate|"Epigallocatechin-Gallate (EGCG) - Sunphenon EGCg:
~Months 1-3: 200 mg EGCG/die (200-0-0 mg)
~Months 4-6: 400 mg EGCG/die (200-0-200 mg)
~Months 7-9: 600 mg EGCG/die (400-0-200 mg)
~Months 10-18: 800 mg EGCG/die (400-0-400 mg)"
16257912|NCT00951834|Drug|Placebo|Placebo
16257913|NCT00951821|Behavioral|Concurrent treatment|Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.
16257914|NCT00951821|Behavioral|Adolescent treatment only|Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase
16257915|NCT00951808|Biological|Single blood transfusion|Participants will receive a single transfusion of 7-13cc/kg packed red blood cells (RBCs) while in the hospital.
16257916|NCT00951808|Behavioral|Standard care|Participants will receive standard care for ACS while in the hospital.
16257917|NCT00951782|Device|High frequency TMS|deep TMS HADD coil
16257918|NCT00951782|Device|Sham TMS|sham deep TMS HADD coil
16257919|NCT00951782|Device|Low frequency TMS|Deep TMS - HADD coil
16257920|NCT00951756|Other|High fat diet|High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
16257921|NCT00951743|Drug|Adaptavir (monomeric DAPTA)|"Intranasal (IN) Solution: 20 mL of solution in a 20 mL polyethylene screw top vial to which a metered sprayer is adapted. Each spray releases approximately 0.1 0.12 mL.
~Available strength - 0.01mg/mI (active study medication), or no mDAPTA (placebo study medication), in water containing 0.25% benzyl alcohol as preservative and 250 mM mannitol (GRAS) to achieve isotonicity.
~Individuals in this study will be randomized to receive mDAPTA or placebo and be instructed to administer four metered nasal spray applications two times a day, in the morning, and in the evening, as close to 12 hours after the morning dose as practical. The planned daily dose of mDAPTA is 8 μg/day."
16257922|NCT00951730|Other|Polysomnography|Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.
16257923|NCT00951717|Behavioral|Behavioral education intervention|One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed
16257924|NCT00951691|Behavioral|Enhanced acute medical rehabilitation|"Daily up to 3-hour sessions of enhanced physical and occupational therapies (see Lenze et al, Enhanced Medical Rehabilitation Increases Therapy Intensity and Engagement and Improves Functional Outcomes in Postacute Rehabilitation of Older Adults: A Randomized-Controlled Trial. J American Medical Director's Association, 2012 for details and outcome data."
16257925|NCT00951691|Behavioral|Treatment as usual|Standard treatment with physical and occupational therapies
16257926|NCT00951678|Other|Observational ultrasonography of venous anatomy|The patient will have ultrasound images obtained of the right and left internal jugular veins as a function of the degree of head rotation and of the right and left femoral veins. Our study is an observational study
16257927|NCT00951665|Drug|paclitaxel|Intravenous repeating dose
16257928|NCT00951665|Drug|pertuzumab [Perjeta]|Intravenous repeating dose
16257929|NCT00951665|Drug|trastuzumab emtansine [Kadcyla]|Intravenous escalating dose
16257930|NCT00951665|Drug|paclitaxel|Intravenous escalating dose
16257931|NCT00951665|Drug|trastuzumab emtansine [Kadcyla]|Intravenous repeating dose
16257932|NCT00951652|Behavioral|CBT|
16257933|NCT00951652|Other|Interpersonal and emotional processing therapy|
16257934|NCT00951652|Behavioral|supportive listening|
16257935|NCT00951639|Dietary Supplement|Cassia cinnamon|5g encapsulated ground bark administered once in experimental session
16257936|NCT00951639|Procedure|50 minutes exercise|50 minutes treadmill endurance exercise at 70% of the heart rate reserve (correlated to VO2max)
16257937|NCT00951639|Dietary Supplement|Cellulose Powder|5g encapsulated powder administered during placebo experimental session
16257938|NCT00951626|Behavioral|exercise intervention|"Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge.
~Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge."
16257939|NCT00951626|Behavioral|telephone-based intervention|"Those on the Standard Nursing Intervention Program will receive phone calls from the Intervention Nurse after the first 3 months and then monthly calls up to 12 months post hospital discharge.
~For those on the Usual Care plus Attention Control program, the Intervention Nurse will be available by phone or email within 48 hours of request for 100 days post transplant."
16257940|NCT00951626|Dietary Supplement|dietary intervention|"Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge.
~Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge."
16257941|NCT00951626|Other|educational intervention|"Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge.
~Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge."
16257942|NCT00951626|Other|questionnaire administration|For both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
16257943|NCT00951626|Procedure|allogeneic bone marrow transplantation|Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant.
16257944|NCT00951626|Procedure|allogeneic hematopoietic stem cell transplantation|Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
16257945|NCT00951626|Procedure|assessment of therapy complications|Collected throughout the 12 month study period
16257946|NCT00951626|Procedure|peripheral blood stem cell transplantation|Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
16257947|NCT00951626|Procedure|psychosocial assessment and care|Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge. They will also receive phone calls from the Intervention Nurse after the first 3 months and then monthly calls up to 12 months post hospital discharge.
16257948|NCT00951626|Procedure|quality-of-life assessment|For both groups of participants, questionnaires administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
16257949|NCT00951626|Procedure|standard follow-up care|Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge. Also the Intervention Nurse will be available by phone or email within 48 hours of request for 100 days post transplant.
16257950|NCT00951613|Drug|NK012|30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m^2 (or 18 mg/m^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.
16257951|NCT00951600|Drug|oxcarbazepine 300 mg/5mL oral suspension|
16257952|NCT00951587|Device|PillCam™ (Capsule Endoscopy)|Medical Device
16257953|NCT00951574|Drug|Nadroparin calcium|Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
16257954|NCT00951574|Drug|saline solution (placebo)|Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
16257955|NCT00951561|Device|Vipon|The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea.
16257956|NCT00951561|Drug|Ibuprofen|400 mg daily
16257957|NCT00951548|Dietary Supplement|VSL#3|Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks
16257958|NCT00951548|Dietary Supplement|Placebo|Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks
16257959|NCT00951535|Other|questionnaire administration|
16257960|NCT00951535|Procedure|quality-of-life assessment|
16257961|NCT00951535|Radiation|image-guided radiation therapy|
16257962|NCT00951535|Radiation|intensity-modulated radiation therapy|
16257963|NCT00951535|Radiation|radiation therapy treatment planning/simulation|
16257964|NCT00951522|Drug|GS-9411|Inhaled GS-9411 dissolved in sterile saline
16257965|NCT00951522|Drug|Placebo|Inhaled placebo in sterile saline
16257966|NCT00951509|Other|Power Mobility Road Test (PMRT)|All subjects will underwent the Power Mobility Road Test (PMRT), and the clinicians scored the driving performance within each condition.
16257967|NCT00951496|Biological|Bevacizumab|Given IV
16257968|NCT00951496|Drug|Carboplatin|Given IV
16257969|NCT00951496|Drug|Carboplatin|Given IP
16257970|NCT00951496|Drug|Cisplatin|Given IP
16257971|NCT00951496|Other|Laboratory Biomarker Analysis|Correlative studies
16257972|NCT00951496|Drug|Paclitaxel|Given IV
16257973|NCT00951496|Drug|Paclitaxel|Given IP
16257974|NCT00951496|Other|Quality-of-Life Assessment|Ancillary studies
16257975|NCT00951483|Drug|Quetiapine-XR|Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.
16257976|NCT00951470|Other|Follow -Up Visits|If CDT is declined, participants will have follow-up visits at 1, 3, and 6 months after study interview.
16257977|NCT00951470|Other|Full CDT|"Monday through Friday visits to the clinic for 2 weeks of intensive outpatient therapy. The CDT will be done by the lymphedema therapist. Each session will last about 1 hour.
~During the last 2 treatment visits (Visits 9 and 10), the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months."
16257978|NCT00951470|Other|Modified CDT Program|The participant will come to the clinic for 1-2 training sessions taught by the lymphedema therapist. Each training session will last about 1 hour, and the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months.
16257979|NCT00951457|Drug|Bendamustine|
16257980|NCT00951444|Biological|dalotuzumab|Given IV
16257981|NCT00951444|Drug|carboplatin|Given IV
16257982|NCT00951444|Drug|gemcitabine hydrochloride|Given IV
16257983|NCT00951431|Drug|Esomeprazole|Esomeprazole 20mg daily for 8 weeks
16257984|NCT00951431|Drug|Placebo|Placebo in the form of study drug
16257985|NCT00951405|Drug|activated recombinant human factor VII, long acting|After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
16258484|NCT00947791|Drug|midazolam|a single IV infusion of midazolam, 0.045 mg/kg
16257986|NCT00951405|Drug|activated recombinant human factor VII, long acting|After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
16257987|NCT00951405|Drug|activated recombinant human factor VII, long acting|After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
16257988|NCT00951392|Drug|euglycemic hyperinsulinemic clamp|"Insulin perfusion at 1 mU.kg-1.min-1
~Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l
~Blood tests"
16257989|NCT00951392|Procedure|muscle biopsy|"Gene expression in muscle tissue will be studied with two approaches :
~Candidate gene approach by quantitative RT-PCR : genes involved in the carbohydrates and lipids metabolism including lipid oxidation in muscle (lipid carriers, PPARs), expression of 7 sirtuins isoforms as well as some of their target genes (NFkB, PGC1a)
~Global transcriptome analysis by DNA Chip"
16257990|NCT00951392|Device|indirect calorimetry|energy expenditure measurement
16257991|NCT00951379|Drug|Pioglitazone hydrochloride|Three (3) pioglitazone 15 mg capsules by mouth once daily for 24 weeks (+/- 1 week)
16257992|NCT00951379|Other|placebo|Three (3) pioglitazone placebo capsules by mouth once daily for 24 weeks (+/- 1 week)
16257993|NCT00951379|Other|laboratory biomarker analysis|Correlative studies
16257994|NCT00951366|Other|Patient Registry|The CHILD Clinic Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period.
16257995|NCT00951340|Other|Cognitive behavioral therapy (CBT)|15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
16257996|NCT00951340|Behavioral|Emotional processing and interpersonal therapy|15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques
16257997|NCT00951340|Behavioral|Listening therapy|15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion
16257998|NCT00951301|Drug|mangosteen juice|6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.
16257999|NCT00951301|Drug|placebo juice|6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.
16258000|NCT00951288|Dietary Supplement|Saffron|Saffron 20 mg/day supplementation
16258001|NCT00951288|Dietary Supplement|Placebo|Placebo
16258002|NCT00951275|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 6 months
16258003|NCT00951275|Drug|Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)|As prescribed
16258004|NCT00951262|Behavioral|a life review program|The life review program includes reviewing a life and formalating a life booklet. Reviewing a life consists of three weekly sessions separately addressing illness experience, adulthood life and childhood and adolescence life. Each session lasts about 30 to 60mintues.A booklet with photos documented significant life events will be produced as a gift for the subjects. The edition, photos and contents fo the booklet are determined by the subjects.
16258005|NCT00951249|Behavioral|Referral of Partners|Referral of up to five sexual partners by index participants for enrollment into the study
16258006|NCT00951249|Behavioral|Screening for STIs and counseling|Identification of STIs and treatment or referral for treatment, if applicable
16258007|NCT00951249|Behavioral|Peer health care system navigators|HIV/STI treatment and other medical and social services
16258008|NCT00951249|Behavioral|Enhanced counseling|Counseling and referral for care offered to participants for issues such as substance use and mental health
16258009|NCT00951236|Drug|One cortisone injection|Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
16258010|NCT00951236|Drug|Two cortisone Injections|Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart
16258011|NCT00951223|Drug|Infergen® (Interferon alfacon-1)|Infergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin
16258012|NCT00951210|Biological|PLX-PAD|IM injection
16258013|NCT00951197|Other|Neuroimaging|Three successive MRI acquisitions to measure FA, MTR and T2 parameters.
16258014|NCT00951184|Behavioral|telephone-based intervention|
16258015|NCT00951184|Other|screening questionnaire administration|
16258016|NCT00951184|Other|study of socioeconomic and demographic variables|
16258017|NCT00951184|Procedure|assessment of therapy complications|
16258018|NCT00951184|Procedure|psychosocial assessment and care|
16258019|NCT00951171|Procedure|Intrauterine Insemination|The intervention arm will undergo temporary (15 minutes) cervical occlusion with the eliptosphere intracervical catheter. This catheter is typically used to perform saline infusion ultrasounds to image the uterine cavity in our practice.
16258020|NCT00951171|Procedure|IUI with the standard inseminator|The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
16258021|NCT00951158|Dietary Supplement|Conjugated Linoleic Acid|"This is a open-label dose-titration trial of CLA in patients with advanced, refractory malignancies. The dose a participant receives is dependent upon the cohort to with the patient is assigned.
~CLA will be given as oral soft gels, once daily, with pharmacokinetic sampling and biopsies (pretreatment and on day 15). Doses will be escalated by patient cohorts, using an accelerated titration design (single-patient cohorts) with expansion to conventional cohort sizes (3-6 patients) once either inhibition of S14 expression or clinical toxicity is observed. Subjects with stable or responsive disease and who tolerate treatment may continue on CLA until the time of disease progression."
16258022|NCT00951158|Drug|Conjugated Linoleic Acid|Phase I Dose Escalation Study
16258023|NCT00951132|Drug|rosuvastatin|10mg tablets, once daily in three months
16258024|NCT00951132|Drug|Placebo|tablet, once daily, three months
16258025|NCT00951119|Device|Resperate|device-guided breathing exercises
16258026|NCT00951119|Device|Resperate|breathing device without slowing of breathing frequency
16258027|NCT00951106|Drug|Pyrimethamine/sulfdoxine (Fansidar)|
16258070|NCT00950846|Drug|Cytoxan|(50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 2 hours (can be given over 1 to 4 hours as determined by the treating physician). The total dose to be given over 4 days is 200 mg/kg.
16258028|NCT00951093|Procedure|Gastric bypass|Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.
16258029|NCT00951080|Device|Traditional NPWT System|Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
16258030|NCT00951080|Device|SNaP Wound Care System|Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
16258031|NCT00951067|Other|Exercise, Elevation, and Compression Garment|"Patients will be asked to daily:
~exercise
~elevate arm
~wear an arm compression garment"
16258032|NCT00951067|Device|E0650 PCD with non-sequential waveform|Use of an E0650 PCD with non-sequential waveform for two hours every day.
16258033|NCT00951067|Device|E0651 PCD with sequential, non-gradient waveform|Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
16258034|NCT00951067|Device|E0652 PCD with sequential, gradient waveform|Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
16258035|NCT00951067|Device|E0652 PCD with peristaltic pulse waveform|Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
16258036|NCT00951054|Drug|NK012|30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m^2 (or 18 mg/m^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.
16258037|NCT00951041|Biological|GSK investigational vaccine GSK2340272A|Two intramuscular injections
16258038|NCT00951041|Biological|GSK investigational vaccine GSK2340269A|Two intramuscular injections
16258039|NCT00951028|Behavioral|Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)|12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications
16258040|NCT00951028|Behavioral|Life-steps adherence treatment|Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
16258041|NCT00951028|Behavioral|Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)|12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.
16258042|NCT00951015|Drug|GSK1349572|investigational HIV-1 integrase inhibitor
16258043|NCT00951015|Drug|efavirenz|approved therapy for HIV-1 infection, used as an internal study control
16258044|NCT00951002|Procedure|acellular dermal matrix plug|anal fistula treated with human acellular dermal matrix plug
16258045|NCT00950989|Drug|AMG 827 70 mg|70 mg AMG 827 SC
16258046|NCT00950989|Drug|AMG 827 140 mg|140 mg AMG 827 SC
16258047|NCT00950989|Drug|AMG 827 210 mg|210 mg AMG 827 SC
16258048|NCT00950989|Drug|Placebo|Placebo SC
16258049|NCT00950989|Drug|Stable weekly dose of methotrexate|Methotrexate
16258050|NCT00950976|Other|citrulline|TID for 5 days
16258051|NCT00950976|Other|Lemonade|TID for 5 days
16258052|NCT00950963|Behavioral|Phone Counseling|Patient were contacted on a periodic basis via telephone to address there diabetes care.
16258053|NCT00950963|Other|Standard Clinical Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
16258054|NCT00950950|Drug|Romosozumab|Administered by subcutaneous injection
16258055|NCT00950950|Drug|Placebo|Administered by subcutaneous injection
16258056|NCT00950924|Device|Simultaneous Vision Bifocal Soft Contact Lenses|Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.
16258057|NCT00950924|Device|Single Vision Soft Contact Lenses|Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction.
16258058|NCT00950911|Drug|amg 162|120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
16258059|NCT00950898|Other|decaff|2 mugs of decaffeinated coffee
16258060|NCT00950898|Other|caffcoff|2 mugs of caffeinated coffee
16258061|NCT00950898|Other|caffeine|2 mugs of hot water containing caffeine
16258062|NCT00950898|Other|placebo|2 mugs of hot water
16258063|NCT00950885|Biological|Low Dose Melatonin|Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.
16258064|NCT00950885|Biological|Placebo|Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.
16258065|NCT00950885|Biological|High Dose Melatonin|Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.
16258066|NCT00950872|Device|Duet TRS|Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
16258067|NCT00950859|Drug|GSK1349572 (Cohort I)|50 mg once daily
16258068|NCT00950859|Drug|GSK1349572 (Cohort II)|50 mg twice daily
16258069|NCT00950846|Drug|Busulfan|"Day -9, -8, -7 and -6
~Patients less than or equal to 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses."
16258071|NCT00950846|Drug|Fludarabine|40 mg/m2/day IV over 1 hour for patients greater than 10 kg, or 1.3 mg/kg/day for patients less than or equal to 10 kg.
16258072|NCT00950846|Procedure|Cord Blood Stem Cell Infusion|The cord blood stem cells will be infused on Day 0.
16258073|NCT00950833|Biological|Pneumococcal vaccine GSK1024850A|1 or 2 intramuscular injections
16258074|NCT00950820|Drug|Oxaliplatin, Capecitabine, Panitumumab|"Panitumumab at a dose of 9 mg/kg BW every three weeks will be administered on day 1 of each cycle just prior to administration of chemotherapy.
~The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15."
16258075|NCT00950820|Drug|Oxaliplatin, Capecitabine|The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.
16258076|NCT00950807|Drug|Tiotropium|long-acting muscarinic receptor antagonist; 18mcg once-daily
16258077|NCT00950807|Drug|Placebo|Inactive/ excipients only
16258078|NCT00950807|Drug|GSK573179|GSK573179 investigational drug
16258079|NCT00950794|Drug|Salmeterol(SN408D)|Salmeterol(SN408D)：long-acting Beta2-agonist
16258080|NCT00950794|Drug|Hokunalin (tulobuterol) tape|Hokunalin (tulobuterol) tape:long-acting Beta2-agonist
16258081|NCT00950781|Procedure|ACTH|During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test.
16258082|NCT00950768|Procedure|Autologous transplantation|Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
16258083|NCT00950755|Biological|tositumomab and Iodine I 131 tositumomab (anti-B1 antibody)|For the treatment of 1st or 2nd relapsed indolent B cell lymphomas or B cell lymphomas that have transformed to a more aggressive histology
16258084|NCT00950742|Drug|Trastuzumab|Load: 4mg/kg-maintain:2mg/kg/week
16258085|NCT00950742|Drug|BIBW 2992|Increased dose cohorts from low dose to MTD
16258086|NCT00950729|Procedure|Driving with running shoes|Participant was asked to do all the experiments with their own running shoes
16258087|NCT00950729|Procedure|Plaster cast|The participant was ask to do all the experiments with a plaster cast molded on his right leg
16258088|NCT00950729|Procedure|Driving with Aircast|The participant was ask to do all the experiments with a aircast on his right leg
16258089|NCT00950716|Behavioral|Patient Peer Support and Empowerment|30 mentors are themselves diabetes patients who have good self care and are motivated to support their peers. The mentors will be trained to deliver peer support intervention under supervision by a program manager. The 300 diabetes patients (mentees) randomized to the peer support group are the intervention targets of these 30 mentors. Telephone-Linked-Communication (TLC) system will be a tool of the mentors for education to the mentees. TLC system utilizes an automatic, interactive, computer-controlled telephone system to monitor and promote diabetes self-management.
16258090|NCT00950716|Behavioral|Usual Care|Subjects in Usual CAre will receive standard care with clinicians' usual follow-up and referral with education to diabetes nurses if deemed necessary at in-charge clinicians' discretion.
16258091|NCT00950690|Drug|Xalatan 0.005% eye drops|ophthalmic solution dosed once daily for 3 months
16258092|NCT00950677|Drug|Byetta (exenatide)|exenatide 5 mcg subcutaneously
16258093|NCT00950677|Drug|Symlin (pramlintide)|pramlintide 60 mcg subcutaneously
16258094|NCT00950664|Drug|Dysport® (abobotulinumtoxinA)|Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
16258095|NCT00950664|Drug|Botox® (onabotulinumtoxinA)|Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
16258096|NCT00950651|Drug|Tramadol HCl Contramid® Once A Day|The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
16258097|NCT00950651|Drug|Tramadol HCl Twice a day|The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
16258098|NCT00950638|Drug|ARC1905|intravitreal injection
16258099|NCT00950625|Drug|lignocaine|200 mg of intraperitoneal lignocaine will be given once during surgery
16258100|NCT00950625|Drug|bupevacaine|100 mg of bupevacaine will be given once during laparoscopic cholecystectomy
16258101|NCT00950612|Biological|GSK's investigational vaccine 692342|Intramuscular injection, 2 doses
16258102|NCT00950612|Biological|Placebo|Intramuscular injection, 2 doses
16258103|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, once daily, 12 weeks
16258104|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 5 mg, once daily, 12 weeks
16258105|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 10 mg, once daily, 12 weeks
16258106|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 20 mg, once daily, 12 weeks
16258107|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 40 mg, once daily, 12 weeks
16258108|NCT00950599|Drug|Saxagliptin|Tablets, Oral, 100 mg, once daily, 6 weeks
16258109|NCT00950599|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
16258110|NCT00950586|Drug|GSK1043702|Oral dose in liquid or tablet formulation
16258111|NCT00950586|Drug|Dextromethorphan|30mg Oral dose
16258112|NCT00950586|Drug|Placebo|To match GSK1034702
16258113|NCT00950547|Device|CARDIOPAT|Cell Saver System at bedside for ICU stay
16258114|NCT00950547|Device|Traditional Chest Drains|Chest drains as usual with no possibility to reinfuse lost blood
16258115|NCT00950534|Drug|INSULIN GLARGINE (HOE901)|The dose of insulin glargine will be titrated toward a fasting plasma glucose (FPG) target of 5.5 mmol/L. Treatment with oral antidiabetic drugs (OADs) prescribed before study entry may continue (except Sitagliptin, Acarbose, Rosiglitazone)
16258116|NCT00950534|Drug|Oral Anti Diabetics (OAD)|Patients treated with the usual standard of care (OAD dose titration, addition of a second or third OAD or referral to an endocrinologist) until optimal doses are reached to maintain a FPG of 5.5 mmol/L
16258117|NCT00950521|Procedure|Intercerebral implantation of Autulogous Stem Cells|2-8 millions Stem cell per patients plus convention therapy
16258118|NCT00950521|Drug|convention therapy|antiplatelet
16258119|NCT00950508|Procedure|High volume plasma exchange|3 high volume plasma exchanges over 3 days
16258120|NCT00950508|Procedure|Standard medical treatment|Standard medical treatment
16258121|NCT00950495|Device|Mandibular Advancement Device (MAD)|This oral appliance keeps the mandible and the tongue in a protruded position. This results in an upper respiratory tract widening and/or reduced collapsibility of the upper airway, thereby preventing the upper airway collapse during sleep.
16258122|NCT00950495|Device|nasal CPAP|The CPAP machine delivers a stream of compressed air via a hose to a nose mask, splinting the airway (keeping it open under air pressure) so that unobstructed breathing becomes possible, reducing and/or preventing apneas and hypopneas
16258123|NCT00950495|Device|placebo|as a placebo, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used
16258124|NCT00950482|Procedure|TA|In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
16258125|NCT00950482|Other|AA|In Alternative acupuncture (AA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
16258126|NCT00950482|Other|WC|Waiting Group
16258127|NCT00950456|Biological|H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)|It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.
16258128|NCT00950443|Device|Acoustic reflection method|Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.
16258129|NCT00950443|Device|Acoustic method and breathing/endoscopic evaluation|Endoscopic evaluation done under general anaesthesia.
16258130|NCT00950430|Drug|Pittsburgh Compound B (C-11 PiB)|Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
16258131|NCT00950430|Drug|F-18 FDG|Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
16258132|NCT00950430|Drug|Tau (18-F-AV-1451)|"PIB PET scan, Tau PET scan and/or FDG PET scan
~Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET TAU scan."
16258133|NCT00950417|Drug|Nimotuzumab|
16258134|NCT00950404|Drug|Viagra 50 mg tablet|Commercial tablet, 50 mg, single dose administered with water
16258135|NCT00950404|Drug|Formulation B ODT tablet 50 mg|Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
16258136|NCT00950404|Drug|Formulation C ODT tablet 50 mg|ODT, 50 mg, single dose administered without water
16258137|NCT00950404|Drug|Formulation D ODT tablet 50 mg|ODT, 50 mg, single dose, administered without water
16258138|NCT00950391|Drug|Tacrolimus|Tacrolimus 3 mg/day taken twice daily to maintain blood level of 3-6 ng/ml for duration of 1 year or less
16258139|NCT00950365|Drug|Erlotinib Hydrochloride|Given PO
16258140|NCT00950365|Other|Laboratory Biomarker Analysis|Correlative studies
16258141|NCT00950365|Drug|Pemetrexed Disodium|Given IV
16258142|NCT00950352|Drug|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
16258143|NCT00950352|Drug|Placebo|Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
16258144|NCT00950339|Drug|omeprazole, 20mg twice daily|"Each patient will undergo 3 phases of drug therapy:
~A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
~At the end of each phase- each patient will undergo the following evaluation:
~Platelet reactivity"
16258145|NCT00950339|Drug|famotidine 40mg twice daily|"Each patient will undergo 3 phases of drug therapy:
~A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
~At the end of each phase- each patient will undergo the following evaluation:
~Platelet reactivity"
16258146|NCT00950339|Drug|pantoprazole 40mg once daily|"Each patient will undergo 3 phases of drug therapy:
~A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily).
~At the end of each phase- each patient will undergo the following evaluation:
~Platelet reactivity"
16258147|NCT00950326|Procedure|Physiotherapy|In intervention group B1, patients with osteoarthritis of the hip or knee will receive specific physiotherapy of the affected hip or knee joint three times a week, but without any disease-specific hydrotherapy. Because of the holistic approach of the clinic, however, these patients will still receive hydrotherapy at sites other than the affected joint, for example, alternate cold and warm affusions of the back or an ascending lumbar affusion.
16258185|NCT00950066|Drug|IRBESARTAN (SR47436)|Oral administration of Irbesartan 150mg or 300mg once a day
16258186|NCT00950066|Drug|Amlodipine|Oral administration of Amlodipine 5mg once a day
16258677|NCT00946556|Drug|Placebo|Placebo po od for 2 months
16258148|NCT00950326|Procedure|Affusion|Patients will receive a specific hydrotherapeutic procedure in the form of alternate cold and warm thigh affusions ( pouring on water) which will consist of repeated cold and warm water stimulation of the knee and hip region (daily). Physiotherapy of other regions, such as the back, is permitted but there will be no specific physiotherapy of the hip or knee joint.
16258149|NCT00950326|Procedure|Affusion/ Physiotherapy|Patients with active osteoarthritis of the hip or knee will receive specific, joint-related hydrotherapy in the form of a (daily) alternate cold and warm thigh affusions as well as joint-specific physiotherapy (three times a week).
16258150|NCT00950313|Other|Self Assessment|Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
16258151|NCT00950313|Other|Electronic risk score|Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.
16258152|NCT00950300|Drug|5-Fluorouracil|Participants will receive 5-fluorouracil, 500 milligrams per meter-squared (mg/m^2) via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8.
16258153|NCT00950300|Drug|Cyclophosphamide|Participants will receive cyclophosphamide, 500 mg/m^2 via IV bolus, on Day 1 of every 21-day cycle during Cycles 5 to 8.
16258154|NCT00950300|Drug|Docetaxel|Participants will receive docetaxel, 75 mg/m^2 via IV infusion on Day 1 of every 21-day cycle during Cycles 1 to 4.
16258155|NCT00950300|Drug|Epirubicin|Participants will receive epirubicin, 75 mg/m^2 via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8.
16258156|NCT00950300|Drug|Herceptin IV [trastuzumab]|Herceptin will be administered as 8 mg/kg (loading dose during Cycle 1) and 6 mg/kg (subsequent cycles) via IV infusion on Day 1 of each 21-day cycle for a total of 18 cycles.
16258157|NCT00950300|Drug|Herceptin SC [trastuzumab]|Herceptin will be administered as fixed dose 600 mg SC on Day 1 of each 21-day cycle for a total of 18 cycles.
16258158|NCT00950287|Device|No intervention|The recordings will be performed in neonatal units with the preterm infant remaining in usual condition with limitations of external stimulation during the study period. The usual monitor will remain in function. The intervention of the nurses in case of apnea will not be modified during the study period. The recording will be obtained from derivation of the signal usually recorded by the monitor in use completed in one centre by a polysomnographic recording (Medtronics France SA), in order to test a possible influence of the sleep status on the detection.
16258159|NCT00950274|Drug|CD133+ autologous bone marrow stem cell|Intramyocardial injection of 5 mL CD133+ cells (0.5-5x10e6 cells) suspended in physiological saline + 10% autologous serum intramyocardially during CABG surgery
16258160|NCT00950274|Drug|Placebo|Intramyocardial injection of 5 mL of physiological saline + 10% autologous serum intramyocardially during CABG surgery
16258161|NCT00950261|Radiation|tri-weekly cisplatin|cisplatin 75mg/m2 every 3 weeks, intravenous, 3 cycles
16258162|NCT00950248|Drug|Idebenone|idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
16258163|NCT00950248|Other|placebo|lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
16258164|NCT00950235|Behavioral|Weight Management|Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy
16258165|NCT00950235|Other|Usual Care|Standard nutrition counseling from Health Plan
16258166|NCT00950222|Drug|Imipenem/Amikacin|patients will received as empirical therapy for VAP imipenem associated with amikacin.
16258167|NCT00950209|Dietary Supplement|saline infusion|"In the first step of the protocol, all the patients will have a kinetic study of the TRL-apoB48 in conditions of a saline infusion to measure the basal production and clearance rates of the TRL-apoB48"
16258168|NCT00950209|Other|euglycaemic hyperinsulinic clamp|an euglycaemic hyperinsulinic clamp to maintain plasma glucose around 1g/l
16258169|NCT00950209|Dietary Supplement|infusion of Endolipide and heparin|an infusion with Endolipide 20 % (12,5 ml/h) and heparin (250 U/h) to prevent the suppressive effect of insulin on plasma free fatty acids
16258170|NCT00950209|Other|hyperglycaemic hyperinsulinic clamp|a hyperglycaemic hyperinsulinic clamp to maintain plasma glucose around 2 g/l to prevent the decreasing effect of insulin on plasma glucose.
16258171|NCT00950196|Drug|amantadine sulphate|amantadine 5/mg/kg for 2 month- tapered up during 2 weeks at 1 month possibility to increase dosage to 8 mg/kg or reduce it if there are side effects
16258172|NCT00950183|Device|Iceman® Cold Therapy unit (djOrtho)|postoperative cold therapy
16258173|NCT00950183|Other|Ice|postoperative cold therapy
16258174|NCT00950170|Procedure|Laboratory Tests|Blood draws to determine the level of factor VIII activity before and after dosing at appropriate visits, and blood draws to determine levels of factor VIII inhibitor (antibody to factor VIII).
16258175|NCT00950157|Other|Presentation of information on approval based on a surrogate outcome and levels of caution|"Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question) statements: no open question statement, non-directive open question statement or directive open question statement."
16258176|NCT00950144|Other|medical chart review|
16258177|NCT00950144|Other|questionnaire administration|
16258178|NCT00950144|Other|study of socioeconomic and demographic variables|
16258179|NCT00950144|Procedure|quality-of-life assessment|
16258180|NCT00950131|Other|Presentation of information about drug approval and level of warning|Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning
16258181|NCT00950105|Drug|CPSI-2364 or placebo|Single, oral dose of CPSI-2364 or placebo
16258182|NCT00950092|Device|Numeris-AF Tethered Coagulation System with VisiTrax|Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
16258183|NCT00950079|Drug|Sodium bicarbonate|3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure
16258184|NCT00950079|Drug|saline|0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure
16258187|NCT00950066|Drug|Irbesartan / Amlodipine|Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day
16258188|NCT00950066|Drug|Placebo|Oral administration of a placebo once a day
16258189|NCT00950053|Procedure|Achilles decompression & debridement|Surgical intervention
16258190|NCT00950053|Procedure|Achilles decompression and debridement with FHL transfer|surgical intervention
16258191|NCT00950040|Behavioral|Brief alcohol intervention|The intervention consists of educational information, aspects of motivational interviewing, feedback concerning alcohol use and measures of glycemic control, alcohol use monitoring, and formulation of a change plan.
16258192|NCT00950040|Behavioral|General health education|The intervention will consist of information about several general health behaviors.
16258193|NCT00950027|Drug|povidone iodine|oropharyngeal decontamination every 4 hours
16258194|NCT00950027|Drug|Placebo|oropharyngeal decontamination every 4 hours
16258195|NCT00950014|Other|Presentation of drug efficacy and side effect data|Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
16258196|NCT00950001|Radiation|Stereotactic Radiosurgery|Undergo SRS
16258197|NCT00949988|Drug|Dasatinib and Rituximab|"In Phase I, subjects will be enrolled into a 3+3 dose escalation scheme with two dasatinib cohort doses of 70 mg QD and 100 mg QD to be given continuously during each 28-day cycle. All subjects will also receive rituximab 500 mg/m2 on day 1 of each cycle (375 mg/m2 on day 1 of cycle 1 only). There will be a pre-phase for each dose cohort when subjects will receive single-agent dasatinib from days -7 to -1 to allow for PK and PD assessment. Cohorts will be assessed for dose-limiting toxicities for two cycles before accrual of additional"
16258198|NCT00949975|Drug|AZD9668|2 x 30 mg oral tablets twice daily (bid) for 12 weeks
16258199|NCT00949975|Drug|AZD9668|2 x 10 mg oral tablets twice daily (bid) for 12 weeks
16258200|NCT00949975|Drug|AZD9668|2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
16258201|NCT00949975|Drug|AZD9668 Placebo|2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
16258202|NCT00949962|Drug|antiandrogen therapy|Given systemically
16258203|NCT00949962|Drug|leuprolide acetate|Given subcutaneously
16258204|NCT00949962|Radiation|3-dimensional conformal radiation therapy|Undergo radiotherapy
16258205|NCT00949949|Drug|everolimus|Given PO
16258206|NCT00949949|Drug|gemcitabine hydrochloride|Given IV
16258207|NCT00949949|Drug|cisplatin|Given IV
16258208|NCT00949936|Device|CAdisc™-L (Total Disc Replacement)|
16258209|NCT00949923|Dietary Supplement|tea capsule|3 tea capsules daily for 3 weeks
16258210|NCT00949910|Drug|Erlotinib|Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.
16258211|NCT00949897|Device|Biofoam|Device
16258212|NCT00949897|Other|Iliac Crest Allograft with locked plate|
16258213|NCT00949884|Drug|olmesartan medoxomil|Oral tablets, once daily, at either 20mg or 40mg daily.
16258214|NCT00949884|Drug|Placebo|placebo oral tablets once daily for two weeks
16258215|NCT00949884|Drug|losartan potassium|losartan potassium oral tablet at either 50mg or 100 mg daily dose.
16258216|NCT00949871|Other|communication analysis|
16258217|NCT00949871|Other|questionnaire administration|
16258218|NCT00949871|Procedure|psychosocial assessment and care|
16258219|NCT00949871|Procedure|support group therapy|
16258220|NCT00949845|Drug|Endotoxin|
16258221|NCT00949832|Dietary Supplement|Vitamin D + Calcium|Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months
16258222|NCT00949832|Dietary Supplement|Calcium|Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; Vitamin B complex (used as placebo) 1 tablet monthly for 6 months
16258223|NCT00949832|Dietary Supplement|Vitamin D2|50,000 IU given orally once
16258224|NCT00949832|Dietary Supplement|Vitamin D3|Vitamin D3 50,000 IU given orally once
16258225|NCT00949819|Other|Active surveillance|Serial, long term data collection and active surveillance
16258226|NCT00949806|Drug|BNT (intradermal injection)|"Patients with severe RLS will receive a one-time intradermal administration of BNT into the most symptomatic areas of both legs.
~Injections will be distributed in a grid distribution pattern covering a total of 20 equidistant sites per symptomatic area. Each symptomatic area will receive a maximum 250 units of BNT (12.5 units per injection). The total BNT injected units should not exceed 1000 units per patient."
16258227|NCT00949793|Device|Endomicroscope|Endomicroscopic images are taken at several positions on the tumor.
16258228|NCT00949780|Drug|Chloral Hydrate|
16258229|NCT00949767|Drug|BMS-866949|(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
16258230|NCT00949767|Drug|BMS-866949|(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
16258231|NCT00949767|Drug|BMS-866949|(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
16258232|NCT00949767|Drug|BMS-866949|(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
16258233|NCT00949767|Drug|BMS-866949|(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
16258234|NCT00949767|Drug|BMS-866949|(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
16258235|NCT00949767|Drug|BMS-866949|(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
16258236|NCT00949767|Drug|Placebo|(Matching volume) - Oral Solution, Oral, once 14 days
16258237|NCT00949754|Drug|honeybee venom (Apitoxin (Korea) Apitox (USA))|multiple intradermal injections of 100 ug pure honeybee venom
16258238|NCT00949728|Procedure|Conjunctival autograft using fibrin glue|Conjunctival autograft using fibrin glue in pterygium surgery
16258239|NCT00949715|Device|Medtronic or Vitatron Dual-Chamber Pacemaker|A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
16258240|NCT00949715|Device|Medtronic SelectSecure 3830 Lead|Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
16258241|NCT00949702|Drug|vemurafenib|960 mg b.i.d. continuous oral dosing
16258284|NCT00949377|Drug|Placebo|Normal saline
16258319|NCT00949078|Drug|omalizumab|omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
16258242|NCT00949689|Behavioral|Cognitive Behavioral Therapy for insomnia and depression|Experimental arm: Participants will receive sessions of cognitive behavioral treatment for insomnia followed by sessions of cognitive behavior treatment for depression for a total of about 10-12 therapy sessions Control arm: Participants will receive brief sleep hygiene and time management techniques and cognitive behavior treatment for depression for a total of about 10-12 therapy sessions.
16258243|NCT00949663|Drug|Placebo|Intravenous infusion of 1% human albumin in normal saline
16258244|NCT00949663|Drug|Glucose-dependent Insulinotropic Polypeptide (GIP)|Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
16258245|NCT00949663|Drug|Xenin-25|Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
16258246|NCT00949663|Drug|Glucose-dependent Insulinotropic Polypeptide plus Xenin-25|Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
16258247|NCT00949650|Drug|Pemetrexed|Pemetrexed IV given once every 3 weeks for up to 6 cycles
16258248|NCT00949650|Drug|BIBW 2992|BIBW 2992 once daily until progression
16258249|NCT00949650|Drug|Cisplatin|Cisplatin IV given once every 3 weeks for up to 6 cycles
16258250|NCT00949637|Behavioral|Scouting Nutrition and Activity Program|Intervention group will receive a curriculum based on social cognitive theory, wherein children will be taught skills in a supportive environment to improve their self efficacy and proxy efficacy toward eating healthful meals and being physically active with a parent. Troop leaders and parents will provide support, and help girls to create healthy opportunities in the home environment. Simultaneously, girls will be taught skills to improve the family mealtime environment, to bolster asking skills toward healthy behavior, to self-monitor healthy behavior, and to set goals for healthy behavior.
16258251|NCT00949637|Behavioral|Standard-care attentional control|Control troops complete usual troop meeting activities. Control troops receive equal observation time, equal pretest and posttest assessment, and equal study scrutiny.
16258252|NCT00949624|Drug|CP-868,596|Oral tablet 60 mg BID continuous
16258253|NCT00949624|Drug|Docetaxel|Intravenous 75 mg/m2 every three weeks
16258254|NCT00949624|Drug|CP-868,596|Oral tablet 100 mg BID continuous
16258255|NCT00949624|Drug|Docetaxel|Intravenous 75 mg/m2 every three weeks
16258256|NCT00949624|Drug|CP-868,596|Oral tablet 100 mg BID continuous
16258257|NCT00949624|Drug|Docetaxel|Intravenous 100 mg/m2 every three weeks
16258258|NCT00949624|Drug|CP-868,596|Oral tablet 60 mg BID continuous
16258259|NCT00949624|Drug|AG-013736|Oral tablet 5 mg BID continuous
16258260|NCT00949624|Drug|Docetaxel|Intravenous 75 mg/m2 every three weeks
16258261|NCT00949611|Behavioral|FRAX + Decision Aid|Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications.
16258262|NCT00949611|Behavioral|FRAX estimated fracture risk|The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
16258263|NCT00949598|Drug|letrozole|Given orally
16258264|NCT00949598|Drug|tamoxifen citrate|Given orally
16258265|NCT00949585|Other|Dietary intake of potassium|Comparison of two diets: one contains 100 mmol potassium per day, and the other contains 40 mmol potassium per day
16258266|NCT00949572|Biological|Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads|1 intramuscular dose (0.5 ml) on month 0, 1 and 4 containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms
16258267|NCT00949572|Biological|Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads|1 sublingual application on month 0, 1 and 4 of 0.5 ml containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms
16258268|NCT00949559|Drug|EP-100|as a single agent administered intravenously twice weekly x 3 with 1 week off (total 28 days)
16258269|NCT00949546|Drug|etanercept|etanercept 50 mg sc twice weekly
16258270|NCT00949533|Drug|Oseltamivir|Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days
16258271|NCT00949520|Other|coronary dual source computed tomography (DSCT)|coronary dual source computed tomography during dipyridamole injection
16258272|NCT00949520|Other|myocardial single photon emission computed topography (SPECT)|myocardial single photon emission computed topography during dipyridamole injection
16258273|NCT00949494|Device|Synvisc|intra-articular, 3 weekly injections
16258274|NCT00949481|Other|Pregnancy Test|Free pregnancy test strips will be supplied to family planning clinics
16258275|NCT00949481|Other|Job aid|"A new job-aid will be given to immunization providers that will guide them in assessing a mother's risk for pregnancy (based on LAM criteria), and guide them in making family planning referrals, including when a woman should start to use a family planning method if she wants to prevent pregnancy. The providers in immunization clinics will be asked to make such an assessment each time a woman has her baby vaccinated.
~Additionally, in family planning clinics located in the same facilities as the immunization clinics, family planning providers will be trained to use and provided with the pregnancy checklist (see links for more information on the checklist)"
16258276|NCT00949455|Drug|lapatinib ditosylate|Given orally
16258277|NCT00949455|Other|Placebo|Given orally
16258278|NCT00949442|Drug|Insulin Glargine (HOE901) [Lantus]|100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
16258279|NCT00949442|Drug|Glimepiride|tablets of 1 and 2 mg
16258280|NCT00949442|Drug|human insulin [NPH]|100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
16258281|NCT00949403|Drug|Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate|injection of C-11 Palmitate and C-11 Acetate during PET/CT to determine Liver metabolism
16258282|NCT00949390|Behavioral|Questionnaire|Survey given at appointment time, then dropped in specified box anonymously.
16258283|NCT00949377|Drug|Methylnaltrexone Bromide (MNTX)|The recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg.
16258285|NCT00949364|Drug|Pomalidomide|"Treatment starts with pomalidomide as single agent therapy: 0.5 mg/day. Prednisolone will be started in the absence of PD as randomized either at start of cycle 4 or start of cycle 7 (starting dose: 30 mg/day for 28 days followed by 15 mg/day and 10 mg/day for 28 days), if no response acc. to IWG-MRT (no CR, PR, CI, TI) was achieved.
~If PD: treatment is stopped. Otherwise, continuous treatment at least until end of cycle 12 is intended. For patients responding to the combination treatment (pomalidomide/prednisolone) a concom. treatment after cycle 6 or 9 (depending on the randomization result) with prednisolone in doses equal or below 7.5 mg/day are allowed.
~If a patient may benefit from treatment with pomalidomide the invest. and the PI will discuss the possibility of further treatment including maintenance treatment with pomalidomide on a case-by-case decision (max. duration: 12 cycles)."
16258286|NCT00949351|Drug|Aliskiren 300mg/d|Aliskiren 300mg/d v.s. placebo for 12wk
16258287|NCT00949338|Procedure|pre-procedural preparation|Patients empty their bladders and consume 6 cups or 3 cups of water 30 minutes before undergoing radiotherapy.
16258288|NCT00949325|Drug|temsirolimus plus liposomal doxorubicin|Patients were treated with temsirolimus (Torisel) weekly by IV and with liposomal doxorubicin (Doxil) (standard dose) by IV once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until dose limiting toxicity (DLT) occurred and the maximally tolerated dose (MTD) was identified. The MTD dose was the standard dose of temsirolimus used for the remainder of the study. Dose modifications were based on protocol parameters for toxicities.
16258289|NCT00949312|Genetic|RNA marker analysis of lymph node and primary tumors|
16258290|NCT00949312|Genetic|microarray profiling of primary tumors|
16258291|NCT00949312|Genetic|reverse transcriptase-polymerase chain reaction of lymph node specimens|
16258292|NCT00949312|Other|diagnostic laboratory RNA and DNA biomarker analysis of primary tumors|
16258293|NCT00949312|Procedure|regional lymph node dissection|
16258294|NCT00949312|Other|lymph node staining for H&E and pancytokeratin IHC|
16258295|NCT00949299|Drug|buprenorphine|intradermal injection
16258296|NCT00949273|Procedure|cylindrical abdominoperineal resection|Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
16258297|NCT00949247|Biological|bevacizumab|Bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
16258298|NCT00949247|Biological|trastuzumab|Trastuzumab IV over 30-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
16258299|NCT00949247|Drug|carboplatin|Carboplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
16258300|NCT00949247|Drug|docetaxel|Docetaxel IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
16258301|NCT00949247|Other|laboratory biomarker analysis|Tumor tissue and bone marrow samples may be collected for further laboratory analysis.
16258302|NCT00949234|Drug|tenofovir + emtricitabine, lopinavir/ritonavir|"The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above standard treatment, creating an expanded regimen:
~Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily"
16258303|NCT00949221|Device|monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE|"group 1: continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months;
~group 2: intensive strategy using continuous glucose monitoring for 12 months;
~group 3: intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring)."
16258304|NCT00949195|Other|Measure pulmonary artery pressure change during exercise|Semi-supine echocardiography test
16258305|NCT00949195|Other|Pulmonary pressure response during exercise|Semi-supine echocardiography test
16258306|NCT00949182|Drug|sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C|After Sorafenib Tosylate has been administered the actual HACE procedure is performed using Doxorubicin Hydrochloride or Mitomycin C
16258307|NCT00949182|Other|laboratory biomarker analysis|
16258308|NCT00949156|Procedure|Different surgical approach and techniques being used to treat three subtype of CP|According to the presurgical MRI, with the analysis of the morphological characteristic of three subtype of CP, different surgical approach and intrasurgical skills were used to treat tumors with trying to total remove tumor and avoid the hypothalamus injury.
16258309|NCT00949143|Other|rear axle position|Wheelchair axle position located as far towards the rear of the wheelchair as possible.
16258310|NCT00949143|Other|forward axle position|Wheelchair will have the axle at least 5cm farther forward than the most rear axle position.
16258311|NCT00949130|Drug|NXL103|BID for 7-14 days
16258312|NCT00949130|Drug|Linezolid|BID for 7-14 days
16258313|NCT00949117|Dietary Supplement|Ensure|Given orally
16258314|NCT00949117|Dietary Supplement|PediaSure|Given orally
16258315|NCT00949117|Drug|cyproheptadine hydrochloride|Given orally
16258316|NCT00949104|Drug|Sucrose|1 ml of 24% sucrose was administered 2 minutes prior to the procedure
16258317|NCT00949104|Drug|Double distilled water|1 ml of double distilled water (Placebo) was administered 2 minutes prior to the procedure
16258318|NCT00949091|Drug|TAK-875|"Randomized, multiple ascending-dose sequence over 14 consecutive days to include the following:
~TAK-875 25 mg tablets, orally
~TAK-875 50 mg tablets, orally
~TAK-875 100 mg tablets, orally
~TAK-875 200 mg tablets, orally
~TAK-875 400 mg tablets, orally
~TAK-875 placebo-matching tablets, orally."
16258320|NCT00949065|Biological|intravenous immunoglobulins|0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks
16258321|NCT00949052|Genetic|DNA analysis|
16258322|NCT00949052|Genetic|polymorphism analysis|
16258323|NCT00949052|Other|laboratory biomarker analysis|
16258324|NCT00949052|Other|medical chart review|
16258325|NCT00949052|Other|questionnaire administration|
16258326|NCT00949052|Procedure|assessment of therapy complications|
16258327|NCT00949052|Procedure|evaluation of cancer risk factors|
16258328|NCT00949039|Drug|Isolated pelvis perfusion|injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
16258329|NCT00949039|Radiation|radiotherapy|chemotherapy and/or radiotherapy and/or surgery
16258330|NCT00949039|Procedure|Surgery|
16258331|NCT00949026|Drug|Temsirolimus (Torisel)|Dose de-escalation dependent on microdialysis results
16258332|NCT00949013|Other|immunohistochemistry staining method|
16258333|NCT00949013|Other|laboratory biomarker analysis|
16258334|NCT00949000|Device|ICD Implantation|Implantation of a commercially available AnalyST or AnalyST Accel ICD
16258335|NCT00948987|Drug|Aspirin|325 mg enteric coated single dose p.o.
16258336|NCT00948974|Behavioral|Cognitive Therapy|"Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005)."
16258337|NCT00948974|Behavioral|Acceptance and Commitment Therapy|ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009).
16258338|NCT00948961|Biological|CDX-1401 in combination with Resiquimod and/or Poly-ICLC|CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
16258339|NCT00948961|Biological|CDX-1401|
16258340|NCT00948961|Biological|Resiquimod|
16258341|NCT00948961|Biological|poly-ICLC|
16258342|NCT00948948|Device|Silicone Gel-Filled Mammary Prostheses|"Mentor Gel-Filled Mammary Prostheses are comprised of a shell made of medical grade silicone elastomer. Gel-filled implant devices manufactured by Mentor will be used in this study:
~Gel-filled device which is available in smooth surface and textured surface (Siltex®)
~Becker Expander/Mammary Prosthesis which is available in both the smooth and the textured (Siltex) version
~Both of these devices were originally indicated for both augmentation and reconstruction mammaplasty procedures, however for purposes of this study, indications are for reconstruction only."
16258343|NCT00948935|Drug|Gemcitabine, Irinotecan, Panitumumab|Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
16258344|NCT00948922|Drug|Bortezomib|AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
16258345|NCT00948922|Drug|Melphalan|AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.
16258346|NCT00948922|Procedure|Autologous Stem Cell Transplant|Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
16258347|NCT00948922|Drug|Fludarabine|Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV
16258348|NCT00948922|Procedure|Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. Allogeneic donor stem cells may also be cryopreserved if they cannot be infused fresh.
16258349|NCT00948909|Drug|Placebo|Placebo intervention
16258350|NCT00948909|Drug|ABT-126|Experimental intervention
16258351|NCT00948909|Drug|donepezil|Active comparator intervention
16258352|NCT00948896|Drug|trimethoprim-sulfamethoxazole (TS; TMP/SMX)|daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
16258353|NCT00948896|Drug|sulfadoxine-pyrimethamine (SP)|monthly dosing given as a single dose, 500mg/25mg tabs
16258354|NCT00948896|Drug|dihydroartemisinin-piperaquine (DP)|monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
16258355|NCT00948870|Drug|Shugan decoction|Decoction ,two times a day,one bag of decoction one time
16258356|NCT00948857|Dietary Supplement|Dehydroepiandrosterone|25 mg PO TID
16258357|NCT00948857|Dietary Supplement|Placebo|Blinded placebo
16258358|NCT00948844|Device|Hybrid (3-d accelerometers, and gyroscopes)|A 3 D accelerometer worn on the lower back or leg
16258359|NCT00948831|Biological|Osteocel Plus|biologic
16258360|NCT00948818|Drug|Linaclotide 290 micrograms|Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
16258678|NCT00946543|Radiation|hypofractionated radiation therapy|
16258361|NCT00948818|Drug|Matching placebo|Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
16258362|NCT00948805|Drug|GnRH agonist|3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation
16258363|NCT00948805|Drug|Control|250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation
16258364|NCT00948792|Procedure|Short platelet transfusion|15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes
16258365|NCT00948792|Procedure|Long platelet transfusion|15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.
16258366|NCT00948779|Other|antibiotic education for children in an emergency care unit|Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
16258367|NCT00948779|Other|antibiotic education for children in an emergency care unit|Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
16258368|NCT00948766|Drug|Rivastigmine 4.6 mg/24 h (5 cm^2)|Rivastigmine was supplied in a 5 cm^2 patch which released 4.6 mg/24 h. Patches were changed daily.
16258369|NCT00948766|Drug|Rivastigmine 9.5 mg/24 h (10 cm^2)|Rivastigmine was supplied in a 10 cm^2 patch which released 9.5 mg/24 h. Patches were changed daily.
16258370|NCT00948766|Drug|Rivastigmine 13.3 mg/24 h (15 cm^2)|Rivastigmine was supplied in a 15 cm^2 patch which released 13.3 mg/24 h. Patches were changed daily.
16258371|NCT00948766|Drug|Placebo|Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.
16258372|NCT00948753|Drug|Maraviroc 150 MG|Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
16258373|NCT00948753|Drug|Maraviroc 300 mg|Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
16258374|NCT00948740|Drug|vitamin D (ergocalciferol)|The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks
16258375|NCT00948727|Behavioral|Dose adaptation according to CN activity monitoring|The protocol of the CALCICLO trial consisted in a CsA dose adaptation during the first 100 days following transplantation. This dose adaptation was performed according to both residual CsA blood and CN activity levels only if the safety of vital functions - especially renal, liver, and neurological - was preserved as assessed by clinical evaluations and laboratory analyses such as creatinine clearance higher than 40 ml/min, serum bilirubin lower than 40 µM and absence of neurological signs. According to the protocol, CsA blood levels and CN activity were measured concomitantly at least once a week from day 0 to day 15, twice a week from day 16 to day 35 and then once a week until day 100.
16258376|NCT00948727|Drug|Cyclosporine (CsA)|Cyclosporine (CsA)
16258377|NCT00948714|Behavioral|Peer Coach Phone Calls|Subjects will receive 3 phone calls from a trained peer coach over 6 months.
16258378|NCT00948714|Behavioral|Health Educator Visits|Subjects will meet 2 times with a trained health educator in the practice
16258379|NCT00948714|Other|written materials|Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle
16258380|NCT00948701|Behavioral|Moving Forward Together 2|RTR volunteers from the ACS will be trained to offer a 12-week telephone-based PA program as a supplement to standard 12-week RTR services.
16258381|NCT00948688|Radiation|Radiation therapy|Once per day, 5 days a week for 6 weeks
16258382|NCT00948688|Drug|5-FU|Intravenously over 24 hours, 7 days per week during each week of radiation therapy
16258383|NCT00948688|Drug|Vorinostat|Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
16258388|NCT00948662|Drug|SAM-760|SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
16258389|NCT00948662|Drug|Placebo of SAM-760|SAM-760 matching placebo capsule, single dose, 1 day,
16258390|NCT00948662|Drug|ketoconazole|Ketoconazole oral tablets, 200 mg bid, 14 days
16258391|NCT00948649|Drug|Placebo|Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.
16258392|NCT00948649|Drug|Varenicline|Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily
16258393|NCT00948623|Behavioral|physical activity counseling program|
16258394|NCT00948623|Behavioral|sham counseling program|
16258395|NCT00948610|Drug|Remicade|Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
16258396|NCT00948584|Other|Insulin dose titration system using a SMS|We applied 'Insulin dose titration system in diabetic patients using a short messaging service automatically produced by a knowledge matrix' for 12 weeks in the intervention group. In the control group, a conventional insulin titration schedule was used. The insulin used in this study was Lantus (insulin glargine).
16258397|NCT00948545|Other|Observational study - there is no intervention|Observational study - there is no intervention
16258398|NCT00948532|Biological|biologic, Osteocel Plus|Osteocel® Plus
16258437|NCT00948207|Behavioral|My Own Resources|"miOwnResources is a personalized, password-protected web portal to high quality websites that provide cancer information, cancer research databases for do your own research, social support, and interactive planning tools. miOwnResources also has a page for participants to add their own weblinks."
16258679|NCT00946543|Radiation|intensity-modulated radiation therapy|
16258399|NCT00948519|Device|Laser + ICG|ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments
16258400|NCT00948519|Device|Laser only|same only without ICG
16258401|NCT00948506|Drug|1% topical cidofovir|1% topical cidofovir
16258402|NCT00948506|Drug|3% topical cidofovir|3% topical cidofovir
16258403|NCT00948506|Drug|Placebo|topical placebo
16258404|NCT00948493|Drug|Buccal insulin spray|Oral insulin spray absorbed in buccal mucosa
16258405|NCT00948480|Biological|Autologous tumor cells plus dendritic cells|A series of 8 vaccinations are administered over 6 months
16258406|NCT00948480|Drug|GM-CSF|500 mcg
16258407|NCT00948467|Drug|TAK-733|"The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
~The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days."
16258408|NCT00948441|Drug|25% ethanol|Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.
16258409|NCT00948441|Other|heparin lock|Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours.
16258410|NCT00948428|Drug|imiquimod|5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
16258411|NCT00948428|Drug|Aldara™|5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
16258412|NCT00948428|Drug|Vehicle Cream|Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
16258413|NCT00948415|Behavioral|Evaluation of the Shape Up RI Campaign|The SURI enhanced group will receive the standard Shape Up RI program. In addition, participants will be asked to record and report their daily calorie intake, body weight, minutes of physical activity, and pedometer steps. Participants will receive automated feedback on progress as well as a behavioral lesson delivered online during each week of the program. Participants assigned to the SURI Standard arm will receive the standard Shape Up RI program. The intervention will take place during the 12-week Shape Up RI campaign.
16258414|NCT00948402|Drug|Metformin|metformin 1250 mg three times daily
16258415|NCT00948402|Drug|oral contraceptive|30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
16258416|NCT00948389|Drug|Dasatinib|Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity
16258417|NCT00948389|Drug|Lomustine|Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity
16258418|NCT00948376|Genetic|IFT80 screening|Natural History
16258419|NCT00948363|Other|Kiwi fruits|Daily intake of 3 kiwi fruits for 8 weeks
16258420|NCT00948363|Other|Apple|Daily intake of 1 apple (equivalent in energy) for 8 weeks
16258421|NCT00948350|Procedure|awake intubation|two anesthesia techniques
16258422|NCT00948337|Behavioral|Brochure of Secondary Cancer Screening|One kind of printed educational material
16258423|NCT00948324|Drug|CSII,ALA,MET,RSG|CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.
16258424|NCT00948298|Drug|Vitamin D|Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
16258425|NCT00948298|Drug|Placebo|Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
16258426|NCT00948285|Procedure|MRI|magnetic resonance imaging (MRI)
16258427|NCT00948272|Biological|Purified Vero Rabies Vaccine - Serum Free|0.5 mL, Intramuscular
16258428|NCT00948272|Biological|Purified inactivated rabies vaccine|0.5 mL, Intramuscular
16258429|NCT00948259|Drug|NP031112|unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
16258430|NCT00948259|Drug|Placebo|unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
16258431|NCT00948246|Device|Easyband®|The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.
16258432|NCT00948233|Behavioral|Video Game|Educational anti-tobacco video game played on arcade-type kiosk for three 30-minute sessions, plus CD-ROM disc of game to use as needed, and series of illustrated materials to go along with computer sessions.
16258433|NCT00948233|Behavioral|Pamphlet|Self-help pamphlet about stopping and avoiding tobacco use, provided by the National Institutes of Health.
16258434|NCT00948233|Behavioral|Surveys|Computer surveys taken at 4 points throughout the study.
16258435|NCT00948220|Drug|peginterferon alfa-2a and ribavirin|standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
16258436|NCT00948207|Behavioral|My Living Story|"Components include:
~1. Life Review Interview by phone (questions based on Chochinov, 2002 dignity enhancing interview);
~2) Edited transcript is delivered in a word format on...;
~3) miLivingStory, a personal social network, where participants can manage content, design and layer; invite and manage their fiends and family.
~4) miStory, a life review education website and portal to websites for: cancer information, databases to do your own research, social support, interactive planning tools, and a page to add their own weblinks."
16258680|NCT00946530|Device|Bright light|Participants uses bright light
16258438|NCT00948194|Drug|Nitric Oxide|Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery
16258439|NCT00948168|Drug|exenatide (Byetta)|all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months
16258440|NCT00948155|Drug|Varenicline|Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
16258441|NCT00948142|Drug|CEM-102|600 mg BID oral tablets for 10-14 days
16258442|NCT00948142|Drug|Linezolid|600 mg BID oral tablets
16258443|NCT00948142|Drug|CEM-102|1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
16258444|NCT00948129|Other|Laboratory Biomarker Analysis|Correlative studies
16258445|NCT00948129|Behavioral|Smoking Cessation Intervention|Undergo standard of care smoking cessation intervention
16258446|NCT00948129|Behavioral|Telephone-Based Intervention|Undergo telephone based smoking cessation intervention
16258447|NCT00948129|Other|Tobacco Cessation Counseling|Undergo smoking cessation counseling
16258448|NCT00948103|Drug|Nitrous Oxide|nitrous oxide inhalation during intravesical injection. Dose depends on gender and pain
16258449|NCT00948103|Drug|Oxygen|oxygen
16258450|NCT00948090|Drug|IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)|Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.
16258451|NCT00948077|Drug|Rifater and EMB|"The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention.
~The patients assigned randomly the Arm Treatment A on the fifth day will be switched to the Arm Treatment B on the sixth day. On the other hand, the patients assigned randomly the Arm Treatment B on the fifth day will be switched to the Arm Treatment A on the sixth day. The flow of intervention is drawn as below.
~Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)"
16258452|NCT00948064|Drug|Vorinostat|200 mg by mouth three (3) times per day with food for 5 days (Days 1 - 5)
16258453|NCT00948064|Drug|Azacitidine|75 mg/m^2/day given intravenously over 15 - 30 minutes daily for 5 days (Days 1 - 5)
16258454|NCT00948051|Dietary Supplement|Follow-on formula supplemented with fructo-oligosaccharides|Follow-on formula supplemented with fructo-oligosaccharides
16258455|NCT00948051|Dietary Supplement|Follow-on formula enriched with placebo (maltodextrins)|Follow-on formula enriched with placebo (maltodextrins)
16258456|NCT00948038|Dietary Supplement|Milk|Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day.
16258457|NCT00948038|Dietary Supplement|Soy|Soy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days,
16258458|NCT00948025|Device|Hollow tube nerve conduit, synthetic or biosynthetic|Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
16258459|NCT00948025|Other|Processed Human Nerve Tissue|Implantation of appropriate length of processed human nerve tissue at time of surgery.
16258460|NCT00947986|Other|1% Johnson's Baby Shampoo|nasal irrigation 2x a day for 4 weeks
16258461|NCT00947973|Behavioral|Challenging Horizons Program (CHP) after-school model|Interventions delivered by a counselor 2 days a week as an after-school program. Interventions will strengthen skills in materials organization, homework management, studying, note taking, and socialization.
16258462|NCT00947973|Behavioral|Challenging Horizons Program (CHP) consultation model|Interventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available
16258463|NCT00947960|Drug|Triheptanoin|1-2 grams triheptanoin (drug)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months followed by 1-2 grams vegetable oil (placebo)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months.
16258464|NCT00947960|Other|Vegetable Oil|1-2 grams vegetable oil (placebo)/kilogram body weight divided into 4 equal doses per day taken with meals and a snack for 6 months followed by 1-2 g triheptanoin (drug)/kilogram body weight for 6 months.
16258465|NCT00947947|Behavioral|Tailored Information Program for Safer Sex|Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
16258466|NCT00947934|Device|Deep brain stimulation|Electrodes (Medtronic 3389) will be implanted in a bilateral way , under local anesthesia, at fornix level in its way through the hypothalamus, very visible on the MRI just before its entrance to mammilary bodies. Electrodes will be connected under general anesthesia to the pectoral sub-cutaneous pacemaker. The electric chronic stimulation (180 Hz, 2-3 V, 120 ms) will be begun the day after the operation
16258467|NCT00947921|Procedure|Plasty|Restrictive Annuloplasty
16258468|NCT00947921|Procedure|Prosthesis|Valve replacement
16258469|NCT00947908|Biological|Hymenoptera venom|Patients are treated with hymenoptera (bee or wasp) venom using subcutaneous injections. The initiation of immune therapy consists of a 52-hour-period in which patients are treated with increasing doses of hymenoptera venom. Afterwards, patients are treated with monthly subcutaneous injections with a fixed dose of hymenoptera venom. Blood will be collected directly before and 1 hour after initiation of immune therapy and after 12 months of immune therapy (directly before the next subcutaneous injection of hymenoptera venom).
16258470|NCT00947895|Drug|Methylprednisolone|IV 1000 mg daily for 3 days
16258471|NCT00947895|Drug|ACTH|IM ACTH 80 mg/day for 5 days.
16258472|NCT00947895|Other|IV placebo|IV placebo (saline) daily for 3 days.
16258473|NCT00947895|Other|IM placebo|IM placebo (saline) daily for 5 days.
16258474|NCT00947882|Drug|Placebo|Mannitol 50 mg/mL solution
16258475|NCT00947882|Drug|Degarelix 10 mg|10 mg degarelix, 40 mg/mL solution
16258476|NCT00947882|Drug|Degarelix 20 mg|20 mg degarelix, 40 mg/mL solution
16258477|NCT00947882|Drug|Degarelix 30 mg|30 mg degarelix, 40 mg/mL solution
16258478|NCT00947856|Drug|brentuximab vedotin|Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
16258479|NCT00947843|Drug|aspirin + pregrel (Clopidogrel resinate)|
16258480|NCT00947843|Drug|aspirin + placebo|
16258481|NCT00947843|Drug|aspirin + plavix (Clopidogrel bisulfate)|
16258681|NCT00946530|Device|Control|Participants uses dim light
16258485|NCT00947778|Other|3 sessions of evaluation tests|3 sessions of evaluation tests, each session during 15 days
16258486|NCT00947778|Other|1 training session|20 sessions of 30 minutes by week during 24 semaines
16258487|NCT00947765|Biological|Autologous blood injection|Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique.
16258488|NCT00947765|Drug|Local corticosteroid injection|Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique
16258489|NCT00947752|Drug|Glatiramer Acetate|Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary.
16258490|NCT00947752|Drug|Experimental Glatiramer Acetate|GA 20 mg/0.5 mL
16258491|NCT00947739|Drug|Camptothecin-20-O-Propionate Hydrate (CZ48)|CZ48 will be administered in successive cohorts of 1 patient per participating site until hints of toxicity (grade 2 or worse adverse events related to the drug) are observed. Then cohort of 3+3 patients will be treated. CZ48 will be administered orally daily for 3 weeks followed by a 1 week rest. (1 course = 4 weeks). No pre-medications will be administered. Patients will be asked to drink 2 liters of fluid daily to flush the bladder.
16258492|NCT00947726|Drug|CeraVe|Using OTC cream on foot twice daily for two weeks.
16258493|NCT00947713|Drug|low dose human chorionic gonadotropin|patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
16258494|NCT00947713|Drug|Clomiphen citrate plus HMG|patients will receive Clomiphen Citrate plus HMG
16258495|NCT00947700|Behavioral|Assessment, Monitoring & Intervention|Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.
16258496|NCT00947687|Drug|PUR003|Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days
16258497|NCT00947687|Drug|Placebo|
16258498|NCT00947674|Device|Cellsorba EX|conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
16258499|NCT00947661|Drug|SPARC0912|Eye drops, once daily, 12 weeks
16258500|NCT00947661|Drug|Reference0912|Eye drops, once daily, 12 weeks
16258501|NCT00947648|Other|Raw Fruits & Vegetables|Diet containing fresh fruits and vegetables in addition to cooked food.
16258502|NCT00947648|Other|Cooked Foods|Diet containing only cooked foods.
16258503|NCT00947635|Dietary Supplement|Dietary intervention - supplements|Supplement bar & spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels
16258504|NCT00947622|Device|Transcranial direct current stimulation|Transcranial Direct current stimulation
16258505|NCT00947596|Drug|atropine sulfate|dry powder for inhalation
16258506|NCT00947596|Drug|atropine sulfate|intramuscular injection
16258507|NCT00947583|Biological|Osteocel Plus|biologic
16258508|NCT00947570|Behavioral|Cognitive behavioral therapy for anxiety|10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
16258509|NCT00947557|Drug|Dutogliptin|Dutogliptin oral administration once daily on background of glimepiride with or without metformin
16258510|NCT00947557|Drug|Placebo|Placebo, oral administration once daily on background of glimepiride with or without metformin
16258511|NCT00947544|Drug|HPN-100|HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4mL) delivers equivalent amount of PBA that 40 tablets of NapBA do.
16258512|NCT00947544|Drug|NaPBA|NaPBA tablets for oral administration and NaPBA powder for oral, nasogastric, or gastrostomy tube administration contain the active ingredient sodium phenylbutyrate. NaPBA is a prodrug and is rapidly metabolized to PAA, the metabolically active compound that conjugates with glutamine via acetylation to form PAGN, which is excreted by the kidneys.
16258513|NCT00947531|Drug|Cerebrolysin|
16258514|NCT00947531|Drug|0.9% Saline Solution|
16258515|NCT00947518|Drug|Chlorhexidine|Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
16258516|NCT00947518|Drug|Normal saline|Cleansing the skin (except the face)with baby wipes containing normal saline
16258517|NCT00947505|Device|HairMax LaserComb 2009, 7 Beam|Device application 3 times week (non-consecutive days), for 26 weeks
16258518|NCT00947505|Device|HairMax LaserComb|Device application 3 times week (non-consecutive days), for 26 weeks
16258519|NCT00947492|Biological|Venous blood sample|Venous blood sample twice a year during 3 years
16258520|NCT00947479|Other|continuous positive airway pressure (CPAP)|After being qualified into the study according to the aforementioned inclusion criteria and after giving an informed consent the polysomnography will be performed in all patients during night rest.In all patients eligible to sleep apnea treatment according to apnea/hypopnea index (AHI, number of apneic/hypopneic episodes per 1 h of effective sleep) from diagnostic polysomnography, CPAP treatment will be introduced under polysomnographic surveillance and the same panel of clinical and biochemical parameters will be evaluated.
16258521|NCT00947466|Drug|Buprenorphine|Transdermal patch
16258522|NCT00947453|Drug|montelukast|montelukast 10 mg once daily for 8 weeks
16258523|NCT00947440|Drug|ABT-072|See arm description for more information
16258524|NCT00947427|Drug|canakinumab (anti IL-1beta)|canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
16258525|NCT00947427|Drug|Placebo|Placebo subcutaneous injections
16258526|NCT00947414|Device|Extracorporeal shockwave therapy|Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises
16258527|NCT00947414|Device|Sham extracorporeal shock wave plus gluteal strength exercise|Sham extracorporeal shock wave plus gluteal strength exercise
16258528|NCT00947388|Drug|Bendamustine Hydrochloride|Bendamustine 70 mg/m2 IV Day 8 and 9 every 28 days for 6 courses of therapy
16258529|NCT00947388|Biological|Alemtuzumab|Given subcutaneously (SC)on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
16258530|NCT00947375|Drug|Lamictal TM|First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and Lamictal TM 150-200 mg in day per so for 12 weeks.
16258531|NCT00947375|Drug|Haloperidol Decanoate|Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
16258532|NCT00947362|Other|Electro-thermo-coagulation|
16258533|NCT00947362|Drug|DAC N-055|moist wound treatment plus 0.05 % pharmaceutical chlorite
16258534|NCT00947362|Drug|saline|physiological saline
16258535|NCT00947349|Drug|ribavirin (RBV)|ribavirin (RBV)
16258536|NCT00947349|Drug|pegylated interferon (PegIFN) alfa-2a|pegylated interferon (PegIFN) alfa-2a
16258537|NCT00947349|Drug|pegylated interferon (PegIFN) alfa-2a|pegylated interferon (PegIFN) alfa-2a
16258538|NCT00947349|Drug|ribavirin (RBV)|ribavirin (RBV)
16258539|NCT00947349|Drug|BI 201335 NA low placebo|Placebo
16258540|NCT00947349|Drug|pegylated interferon (PegIFN) alfa-2a|pegylated interferon (PegIFN) alfa-2a
16258541|NCT00947349|Drug|ribavirin (RBV)|ribavirin (RBV)
16258542|NCT00947349|Drug|BI 201335 NA high|BI 201335 NA high
16258543|NCT00947349|Drug|BI 201335 NA low|BI 201335 NA
16258544|NCT00947349|Drug|BI 201335 NA high placebo|placebo
16258545|NCT00947349|Drug|BI 201335 NA high|BI 201335 NA high
16258546|NCT00947349|Drug|Placebo|
16258547|NCT00947336|Drug|Norfloxacin + Synbiotic|Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d.
16258548|NCT00947336|Drug|Norfloxacin + Placebo|Norfloxacin 400 mg once daily with placebo
16258549|NCT00947323|Drug|Simvastatin|simvastatin 20 daily for six months.
16258550|NCT00947323|Drug|Placebo|
16258551|NCT00947310|Device|Standard ICD programming|Standard ICD programming
16258552|NCT00947310|Device|High rate cutoff|Programming of a high rate cutoff
16258553|NCT00947310|Device|Long delay|Programming of a prolonged delay
16258554|NCT00947297|Drug|HPN-100|HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do.
16258555|NCT00947284|Drug|nalbuphine plus naloxone|single dose administered intravenously
16258556|NCT00947284|Drug|nalbuphine plus saline|single dose administered intravenously
16258557|NCT00947284|Drug|naloxone plus saline|single dose administered intravenously
16258558|NCT00947271|Behavioral|DVD 1|The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health
16258559|NCT00947271|Behavioral|DVD 2|The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health
16258560|NCT00947258|Other|Stretching|Participants were divided into 3 groups. The group was referred to stretching 3 weekly for 4 consecutive weeks. Group B went 4 weeks without any intervention and held only one stretch before the re-test. And the group C performed passive knee mobilization. All participants were assessed for goniometry of the knee in flexion and extension and peak torque and power on the isokinetic dynamometer.
16258561|NCT00947245|Drug|BMS-791325|Capsules, Oral, 300 mg, Single Dose, One day
16258562|NCT00947245|Drug|BMS-791325|Capsules, Oral, 900 mg, Single Dose, One day
16258563|NCT00947245|Drug|BMS-791325|Capsules, Oral, ≤1200 mg, Single Dose, One day
16258564|NCT00947245|Drug|BMS-791325|Capsules, Oral, 300 mg, Every 12 hours, 14 days
16258565|NCT00947245|Drug|BMS-791325|Capsules, Oral, 900 mg, once daily 14 days
16258566|NCT00947245|Drug|BMS-791325|Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
16258567|NCT00947245|Drug|Placebo|Capsules, Oral, Single Dose, One day
16258568|NCT00947245|Drug|Placebo|Capsules, Oral, Every 12 hours, 14 days
16258569|NCT00947245|Drug|Placebo|Capsules, Oral, Once Daily, 14 days
16258570|NCT00947245|Drug|Placebo|Capsules, Oral, Every 12 hours or once daily, 14 days
16258571|NCT00947232|Behavioral|Motivational interviewing|Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
16258572|NCT00947232|Behavioral|Education|Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.
16258573|NCT00947219|Device|HairMax LaserComb|Device application 3 times week (non-consecutive days), for 26 weeks
16258574|NCT00947219|Device|Control device|Device is used 3 times a week on non-consecutive days
16258575|NCT00947206|Behavioral|LHWO about CRC|2 LHWO sessions and 2 telephone calls aimed at increasing their CRC screening receipt
16258576|NCT00947206|Behavioral|Nutrition Education + CRC brochure|Bilingual CRC brochure as well as a lecture on healthy nutrition for cardiovascular health and a post-intervention LHWO session on CRC screening.
16258577|NCT00947193|Drug|Ataluren|Oral powder
16258578|NCT00947180|Behavioral|Biofeedback|Electromyographic (EMG) activity was recorded from sensors placed in the anal canal, averaged, and displayed to patients to help them learn to relax the pelvic floor muscles during straining.
16258579|NCT00947180|Other|Electrogalvanic stimulation|Electrical stimulation was applied to pelvic floor muscles through an anal plug. Frequency was 80 pulses per sec, and voltage was slowly increased from 0 to 150-350 volts as tolerated.
16258580|NCT00947180|Behavioral|Digital massage|Using a gloved finger, the therapist pressed on the levator ani as firmly as tolerated and moved the finger from side to side 3-4 times.
16258581|NCT00947167|Drug|pertuzumab|840 mg, 420 mg, iv
16258582|NCT00947167|Drug|erlotinib|150 mg, PO
16258583|NCT00947154|Drug|aripiprazole|aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
16258682|NCT00946517|Other|Questionnaires|Parenting and behavioral questionnaires
16258584|NCT00947141|Drug|ganciclovir (start when CMV PCR >200copies / ml x2)|"Group A: Start ganciclovir when CMV PCR >200copies / ml x 2) . Participants are randomised to either Monitor or Treat. If monitored, treatment will only begin if viral load has increased > 3,000. If treated (and monitored) treat until <200 copies on 2 consecutive occasions.
~Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B"
16258585|NCT00947141|Other|Monitor (Treatment starts when CMV PCR >3,000 copies / ml)|"Group A: CMV viral load between 200-3,000 copies/ml (on 2 occasions). Participants are randomised to either Monitor or Treat. If monitored, treatment will only begin if viral load has increased > 3,000. If treated (and monitored) treat until <200 copies on 2 consecutive occasions.
~Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B"
16258586|NCT00947141|Drug|Stop treatment when 2 levels CMV PCR <3,000 copies / ml|"Group B: Viral load > 3,000 copies/ml. Participants are randomised to treat until < 3,000 copies/ml on 2 occasions or treat until <200 copies/ml on 2 consecutive occasions.
~Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B"
16258587|NCT00947141|Other|Monitor (Treatment stops CMV PCR <200 copies / ml x2)|"Group B: Viral load > 3,000 copies/ml. Participants are randomised to treat until < 3,000 copies/ml on 2 occasions or treat until <200 copies/ml on 2 consecutive occasions.
~Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B"
16258588|NCT00947128|Drug|Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)|
16258589|NCT00947128|Drug|Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)|
16258590|NCT00947115|Procedure|Blood sampling|Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
16258591|NCT00947115|Procedure|Cervico-vaginal secretion (CVS) samples|CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
16258592|NCT00947102|Other|Observation|
16258593|NCT00947089|Device|oxidized regenerated cellulose (Fibrillar SURGICEL)|one gauze made of ORC
16258594|NCT00947089|Device|iodoform gauze|one iodoform gauze
16258595|NCT00947076|Drug|Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)|
16258596|NCT00947076|Drug|Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)|
16258597|NCT00947063|Drug|Promethazine HCl 50 mg Tablets (Sandoz, Inc)|
16258598|NCT00947063|Drug|Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)|
16258599|NCT00947050|Other|dynamic physical exercise|dynamic supine bicycle exercise for 6 minutes
16258600|NCT00947037|Drug|AP-CD/LD|
16258601|NCT00947024|Drug|10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.|
16258602|NCT00947024|Drug|10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.|
16258603|NCT00947024|Drug|10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.|
16258604|NCT00947011|Drug|Placebo|1 tablet 100 mg once a day
16258605|NCT00947011|Drug|Januvia|1 tablet 100 mg once a day
16258606|NCT00946998|Drug|Sertraline|Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d
16258607|NCT00946998|Drug|placebo|Placebo tablet will be identical and matched to sertraline tablet.
16258608|NCT00946985|Drug|paliperidone palmitate|50, 75, 100, or 150 mg eq. monthly injection for 2 years
16258609|NCT00946985|Drug|oral risperidone|2, 4, 6, or 8 mg tabs once daily for two years
16258610|NCT00946972|Drug|JNJ-38431055; Placebo|
16258611|NCT00946959|Procedure|Cardiac surgery|A study-certified cardiothoracic surgeon must deem a patient, who otherwise fulfills all inclusion and exclusion criteria for any cardiac surgery (conventional, off-pump cardiac surgery). The procedure must be performed as soon as possible.
16258612|NCT00946946|Drug|Azathioprine|2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
16258613|NCT00946946|Drug|Mesalazine|4g Mesalazine tablets/day AND azathioprine placebo tablets
16258614|NCT00946946|Drug|Azathioprine placebo|4g Mesalazine tablets/day AND azathioprine placebo tablets
16258615|NCT00946946|Drug|Mesalazine placebo|2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
16258616|NCT00946933|Dietary Supplement|NH4Cl (ammonium chloride)|0.2 g/kg/day of NH4Cl (ammonium chloride)
16258617|NCT00946933|Dietary Supplement|placebo|0.025 g/kg/day of NaCl (sodium chloride)
16258618|NCT00946920|Drug|Degarelix|The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
16258619|NCT00946920|Drug|Goserelin acetate|The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
16258620|NCT00946907|Drug|Aspirin|3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
16258621|NCT00946907|Drug|placebo|3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days
16258622|NCT00946894|Procedure|Total thyroidectomy|Total thyroidectomy
16258623|NCT00946894|Procedure|Dunhill operation|Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
16258624|NCT00946894|Procedure|Bilateral subtotal thyroidectomy|Bilateral subtotal thyroidectomy
16258683|NCT00946504|Drug|Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)|
16258684|NCT00946504|Drug|Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)|
16258685|NCT00946491|Drug|Haloperidol 10 mg Tablets (Cord Laboratories)|
16258686|NCT00946491|Drug|Haldol 10 mg Tablets (McNeil Pharmaceuticals)|
16258981|NCT00944385|Drug|ulinastatin|Administer 30000U/ulinastatin. Comparison of different dosages of drug.
16258625|NCT00946881|Drug|WST 11 -mediated -VTP|The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.
16258626|NCT00946842|Drug|Treatment A|Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
16258627|NCT00946842|Drug|Treatment B|Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
16258628|NCT00946842|Drug|Treatment C|Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
16258629|NCT00946842|Drug|Treatment D|Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
16258630|NCT00946842|Drug|Treatment E|Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
16258631|NCT00946842|Drug|Treatment F|Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58
16258632|NCT00946829|Drug|telmisartan|
16258633|NCT00946816|Behavioral|Nutritional Intervention|Nutritional Intervention
16258634|NCT00946803|Behavioral|Patient-Controlled Cognitive-Behavioral Intervention|Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player to be used at least once per day or more frequently, as needed for pain, fatigue, and sleep disturbance.
16258635|NCT00946790|Drug|Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)|
16258636|NCT00946790|Drug|Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)|
16258637|NCT00946777|Other|Systane® Ultra|Systane® Ultra 1-2 drops, 4 times per day for 30 days
16258638|NCT00946764|Drug|Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)|
16258639|NCT00946764|Drug|Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)|
16258640|NCT00946751|Drug|Levetiracetam Tablets, 750 mg (Sandoz Inc.)|
16258641|NCT00946751|Drug|Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)|
16258642|NCT00946738|Other|Biofeedback|Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.
16258643|NCT00946738|Other|Deep oscillation|Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.
16258644|NCT00946725|Drug|Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)|
16258645|NCT00946725|Drug|Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)|
16258646|NCT00946712|Biological|Bevacizumab|Given IV
16258647|NCT00946712|Drug|Carboplatin|Given IV
16258648|NCT00946712|Biological|Cetuximab|Given IV
16258649|NCT00946712|Other|Laboratory Biomarker Analysis|Correlative studies
16258650|NCT00946712|Drug|Paclitaxel|Given IV
16258651|NCT00946699|Biological|MEDI-551|0.1 mg/kg
16258652|NCT00946699|Biological|Placebo|0.3 mg/kg
16258653|NCT00946699|Biological|MEDI-551|1.0 mg/kg
16258654|NCT00946699|Biological|MEDI-551|3.0 mg/kg
16258655|NCT00946699|Biological|MEDI-551|10.0 mg/kg
16258656|NCT00946699|Other|Placebo|Placebo
16258657|NCT00946686|Drug|Leflunomide 20 mg Tablets (Geneva Pharmaceutical)|
16258658|NCT00946686|Drug|Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)|
16258659|NCT00946673|Drug|Vorinostat|Orally up to 400 mg
16258660|NCT00946673|Procedure|Radiation Therapy|Single fraction stereotactic radiotherapy - Standard of Care
16258661|NCT00946647|Drug|Panobinostat (LBH589)|Panobinostat was supplied by Novartis as immediate-release hard gelatin capsules in strengths of 5 mg, 10 mg, and 20 mg packaged in high density polyethylene bottles.
16258662|NCT00946647|Drug|5-Azacytidine|
16258663|NCT00946634|Drug|Ozone|Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. After a last foaming with ozone gas (Philozon, Santa Catarina, Brazil) at 40mg/L concentration.
16258664|NCT00946634|Drug|Control (no last irrigation)|Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes.
16258665|NCT00946634|Drug|Aqueous Ozone|Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. A last irrigation with 10mL of ozonated water at 40mg/mL concentration
16258666|NCT00946621|Drug|Ramipril 10 mg Capsule (Sandoz)|
16258667|NCT00946621|Drug|Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)|
16258668|NCT00946608|Drug|Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)|
16258669|NCT00946608|Drug|Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)|
16258670|NCT00946608|Drug|Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)|
16258671|NCT00946595|Drug|efavirenz/emtricitabin/tenofovir|1x600/200/245 mg per day (one tablet) between W0 et W98
16258672|NCT00946595|Drug|lopinavir/ritonavir|4 x 200/50 mg (4 tablets) once a day between W0 and W98
16258673|NCT00946582|Behavioral|Barkley's parenting management program|It is a parent training group to teach behavior therapy techniques to parents of children with ADHD. The group will contain about 10 parents of children with ADHD. It will be conducted 1.5 hour per session, one session per week, and 11 sessions totally.
16258674|NCT00946569|Drug|JNJ39758979|Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.
16258675|NCT00946569|Drug|Placebo|Participants will receive matching placebo once daily orally for 12 weeks.
16258676|NCT00946556|Drug|Valacyclovir|1g po od for 2 months
16258687|NCT00946478|Drug|Pimecrolimus|"20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
16258688|NCT00946478|Other|Vehicle cream|"20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
16258689|NCT00946465|Drug|Ramipril 10 Capsule (Sandoz)|
16258690|NCT00946465|Drug|Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)|
16258691|NCT00946439|Device|Wheel assisted running training|'Race-Runner' uses the principle of body weight reduction and wheel assisted running training. This is a three-wheel device specifically designed in the 1990s for athletic purposes. The participant is walking or running with the feet on the ground while using a triangular frame equipped with three large bicycle wheels. Support to the participant's body is provided by a regular cycle saddle, a frontal body support plate, and the steering handlebars. The vertical and horizontal distance of the saddle and frontal support from the steering handlebars are adaptable to the participant's body dimension and comfort. This equipment is commonly used in competition in Scandinavia and Central Europe
16258692|NCT00946426|Other|Clamp|Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history
16258693|NCT00946413|Behavioral|CBT plus parent education|The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution. The issues taught and discussed included an introduction to adolescent depression and suicide, their etiology, symptoms, treatment, and prognosis, as well as stress management. A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
16258694|NCT00946413|Behavioral|CBT alone|The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
16258695|NCT00946400|Other|Scoring 4Ts and Chong scale|Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.
16258696|NCT00946400|Other|Blood draw|Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT.
16258697|NCT00946387|Drug|Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)|
16258698|NCT00946387|Drug|Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)|
16258699|NCT00946374|Drug|Immunochemotherapy|R-CHOP: Rituximab 375 mg/m²,intravenous ( iv ), day 0 ; Cyclophosphamide 750 mg/m²,iv, day1; Vincristine 1,4 mg/m² but at the maximum 2 mg,iv,d1; Doxorubicin 50 mg/m², iv, d1; Prednisone 100 mg, peroral ( po ), day 1 to day 5
16258700|NCT00946374|Drug|High-dose BEAM plus autologous SCT|High-dose BEAM: Carmustine 300mg/m², iv, day -7; Cytarabine 2 x 200 mg/m², iv, day -6 to day -3; Etoposide 2 x 100 mg/m², iv, day -6 to day -3; Melphalan 140 mg/m², iv, day -2 followed by Autologous stem cell transplantation ( > 2,5 x 10e6 CD34 positive autologous stem cells, iv, day 0
16258701|NCT00946374|Other|HLA-identical allogenic SCT|Fludarabine 30 mg/m², iv, day -4 to day -2; Cyclosporin A 2 x 3mg/kg, iv, day -1 to day 0 plus total body irradiation with 2 Gy, day 0 followed by allogenic stem cell transplantation immediately after Radiation.
16258702|NCT00946361|Other|Examinations|Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray
16258703|NCT00946348|Drug|Dronabinol|Dronabinol 10 mg or 15 mg
16258704|NCT00946348|Drug|Cannabis|Cannabis cigarette
16258705|NCT00946335|Drug|veliparib|Given PO
16258706|NCT00946335|Drug|temozolomide|Given PO
16258707|NCT00946335|Other|pharmacological study|Correlative studies
16258708|NCT00946335|Other|laboratory biomarker analysis|Correlative studies
16258709|NCT00946322|Behavioral|Couple-Based Treatment for Alcohol Use Disorders and PTSD|This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
16258710|NCT00946309|Drug|High Sulforaphane Extract (Broccoli Sprout Extract)|100 umol sulforaphane, every other day for 5 weeks
16258711|NCT00946309|Drug|Microcrystalline Cellulose NF (placebo)|250 mg every other day for 6 weeks
16258712|NCT00946296|Drug|Potassium Iodide|8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
16258713|NCT00946283|Dietary Supplement|Lactobacillus rhamnosus GG|Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water
16258714|NCT00946270|Drug|CC-4047|0.5 mg capsules daily by mouth day 1 through day 28.
16258715|NCT00946270|Drug|Prednisone|30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
16258716|NCT00946270|Drug|CC-4047|3.0 mg capsules daily by mouth day 1 through 21.
16258717|NCT00946257|Drug|Otelixizumab|A humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb) directed against the ε domain of the human lymphocyte antigen CD3.
16258718|NCT00946205|Procedure|Laparoscopic posterior rectopexy|The rectum is mobilised down to the os coccygeus, then it is elevated cephalic and sutured with a multifilament suture to the presacral fascia just below the sacral promontory. The lateral stalks should be left intact.
16258798|NCT00945672|Drug|placebo|placebo administered every 90 days or monthly to match experimental treatment arms.
16258799|NCT00945659|Device|Continuous Glucose Sensor|Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
16260211|NCT00935805|Drug|Captopril|50 mg TID
16258719|NCT00946205|Procedure|Laparoscopic anterior mesh rectopexy|The peritoneum is incised over the right side of the promontory. The incision is extended in an inverted J-form along the right side of rectum and over the deepest part of the pouch of Douglas. Denonvilliers fascia is incised and the rectovaginal (women)/rectovesical (men) septum is broadly opened. A prosthetic mesh (3 x 17 cm) is sutured with nonabsorbable sutures to the ventral aspect of the rectum in the rectovaginal/rectovesical septum and to the lateral seromuscular borders of rectum and fixed upon the promontory using a stapler. The posterior fornix of vagina (women)/floor of the bladder (men) is elevated and sutured to the anterior aspect of the mesh. The incised peritoneum is then closed over the mesh.
16258720|NCT00946192|Drug|Transdermal 17Beta-estradiol, progesterone|100 mcg/day 17Beta-estradiol; transdermal twice weekly application for 12 months (with cyclic micronized progesterone pills (Prometrium): 200 mg taken orally daily Day 1 to Day 12 each month) + Elemental calcium 1200 mg and Vit D 400 IU taken orally daily
16258721|NCT00946192|Drug|Ethinyl Estradiol + Desogestrel|Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily
16258722|NCT00946192|Dietary Supplement|Sham Comparator|Elemental calcium 1200 mg and Vit D 400 IU taken orally daily
16258723|NCT00946179|Biological|Influenza virus (split virion, inactivated) vaccine|0.5 mL, Intramuscular
16258724|NCT00946166|Drug|simvastatin|40 mg daily in the evening for a maximum of 14 days
16258725|NCT00946166|Drug|Placebo|Simvastatin-like placebo administered daily in the evening for a maximum of 14 days
16258726|NCT00946153|Drug|Lenvatinib|In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.
16258727|NCT00946140|Procedure|DCE-MRI scans|Initially you will be given safety information about MRI scans and a questionnaire to determine your compatibility with the MRI scanner. For each patient, DCE-MRI data sets will be acquired three times - at baseline just prior to the start of the drug therapy, within 24-48 hours of the start of the therapy, and within 6-8 weeks of the start of the therapy.
16258728|NCT00946127|Procedure|Ventriculoperitoneal Shunt Placement|In the subjects who choose this arm, at the start of study- CSF (Cerebrospinal fluid ) will be shunted to peritoneum by placing a ventriculoperitoneal shunt catheter with or without shunt valves or anti-siphon device.
16258729|NCT00946127|Procedure|Endoscopic Third Ventriculostomy(ETV)|Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.
16258730|NCT00946114|Drug|sildenafil|tablets, 20mg, TID, 112 weeks at the maximum
16258731|NCT00946114|Drug|sildenafil|tablets, 20mg x 4 (80mg), TID, approximately 70 weeks
16258732|NCT00946101|Biological|MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]|0.5 mL: (intranasal sprayer)
16258733|NCT00946101|Biological|Placebo|Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer
16258734|NCT00946088|Drug|Progesterone|Progesterone 400 mg per vagina qhs.
16258735|NCT00946088|Drug|Polyethylene glycol&hydrogenated vegetable oil.|Placebo Comparator: Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina qhs.
16258736|NCT00946062|Other|orientation and mobility training|orientation and mobility training
16258737|NCT00946049|Device|Vicryl Plus|
16258738|NCT00946049|Device|Vicryl|
16258739|NCT00946036|Drug|Sertraline Hydrochloride|
16258740|NCT00946023|Drug|Fludarabine|Days -6 through -2: 30 mg/m^2 IV daily
16258741|NCT00946023|Drug|Cyclophosphamide|Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
16258742|NCT00946023|Radiation|Total body irradiation|Day -1: 200 centigray (cGy) in a single fraction
16258743|NCT00946023|Drug|Tacrolimus|Start on Day 5 through Day 180
16258744|NCT00946023|Drug|Mycophenolate Mofetil|Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
16258745|NCT00946023|Drug|Rituximab|Day 30 and every week after for 8 total doses: 375 mg/m^2 IV
16258746|NCT00946023|Biological|Allogeneic Bone Marrow Transplant (BMT)|Day 0: Donor bone marrow infusion
16258747|NCT00946010|Biological|blood sampling and abdominal sonography|10cc blood sampling and abdominal sonography
16258748|NCT00945997|Drug|misoprostol|mifepristone 200 mg followed by 200 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.
16258749|NCT00945997|Drug|misoprostol|mifepristone 200 mg followed by 400 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.
16258750|NCT00945984|Procedure|Radical nephrectomy|Surgical options to treat localized renal cell carcinoma
16258751|NCT00945971|Other|Physical activity|The intervention group will engage in exercise program, including aerobic and anaerobic components,twice a week, for 3 months. Exercise testing, blood sampling and cognitive assessment will be used at the start and in the end of this study.
16258752|NCT00945958|Drug|SPARC0913|One drop of SPARC0913 in affected eye once daily for 24 weeks
16258753|NCT00945945|Drug|Duloxetine (DLX)|dose daily by mouth
16258754|NCT00945945|Drug|Placebo (PLA)|Placebo Comparator daily by mouth
16258755|NCT00945932|Drug|GW870086X|Investigational product
16258756|NCT00945932|Drug|Placebo|Placebo control
16258757|NCT00945919|Drug|Oxymorphone ER|Rapid Opioid rotation/titration
16258758|NCT00945906|Biological|FXIII Concentrate (Human) (FXIII)|"Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.
~Subjects enrolled in this study who have not received at least 3 doses of FXIII Concentrate in a previous study of this product (i.e., NCT00640289, NCT00885742, or NCT00883090) will initially receive a dose of 40 U/kg by intravenous (IV) infusion."
16258759|NCT00945893|Biological|MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]|0.5 mL; (intranasal sprayer)
16258760|NCT00945893|Other|Placebo|(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)
16258761|NCT00945880|Drug|clemizole hydrochloride|Two 50 mg capsules containing clemizole hydrochloride are to be administered orally twice a day for 28 days for a total daily dose of 200 mg. Followed immediately by standard of care treatment consisting of interferon and ribavirin
16260212|NCT00935805|Drug|Amlodipine|10 mg QD
16258762|NCT00945854|Other|Wholegrain cereal diet|Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.
16258763|NCT00945854|Other|Refined cereal diet|Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.
16258764|NCT00945841|Biological|inactivated split influenza vaccine|1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010
16258765|NCT00945828|Behavioral|Annual Intervention Group|Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.
16258766|NCT00945828|Behavioral|Quarterly Monitoring of IEP|Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.
16258767|NCT00945815|Biological|epratuzumab|
16258768|NCT00945815|Drug|clofarabine|
16258769|NCT00945815|Drug|cytarabine|
16258770|NCT00945815|Other|laboratory biomarker analysis|
16258771|NCT00945802|Drug|FST-201 (dexamethasone 0.1%) Otic Suspension|Instill four drops two times a day
16258772|NCT00945802|Drug|ciprofloxacin 0.3%, dexamethasone 0.1%|Instill four drops two times a day
16258773|NCT00945789|Drug|Human recombinant erythropoietin|Epo dse is 2500 IU/kg subcutaneous daily for 5 days.
16258774|NCT00945789|Procedure|EEG and Brain MRI|EEG to be done twice in hte first 48 hours and at 2-3 weeks. MRI to be done at 3 weeks of age.
16258775|NCT00945789|Biological|Nitric oxide measurement in the blood|Concentration of nitric oxide is measured in the blood at enrollment. For the 2 groups with asphyxia, measurement to be repeated in 2 weeks.
16258776|NCT00945776|Behavioral|Weekly phone calls|Calling weekly to answer questions regarding CPAP usage.
16258777|NCT00945776|Behavioral|Frequently asked questions|Answers to frequently asked questions in pre-printed form.
16258778|NCT00945776|Behavioral|Usual care|Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.
16258779|NCT00945763|Drug|N1539|30 mg
16258780|NCT00945763|Drug|placebo|tablets
16258781|NCT00945763|Drug|N1539|15 mg
16258782|NCT00945763|Drug|N1539|60 mg
16258783|NCT00945763|Drug|Motrin|400 mg
16258784|NCT00945750|Drug|Famotidine FCT|Famotidine 20 mg oral film-coated tablet taken once daily
16258785|NCT00945750|Drug|Famotidine CT|Famotidine 20 mg oral chewable tablet taken once daily
16258786|NCT00945737|Dietary Supplement|Soy protein; 25 grams/day|Soy protein
16258787|NCT00945737|Dietary Supplement|Control protein|Milk protein
16258788|NCT00945724|Drug|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate|"Weeks 1-15:
~6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
~Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
~IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4&5 of R-CHOP
~Weeks 18-22:
~• Methotrexate 1.5 g/m2 q14 Days x 2
~From Week 24:
~• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)"
16258789|NCT00945698|Dietary Supplement|Lipid-based nutrient supplement, 10gM|"140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258790|NCT00945698|Dietary Supplement|Lipid-based nutrient supplement, 20gM|"280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258791|NCT00945698|Dietary Supplement|Lipid-based Nutrient Supplement, 20gNoM|"280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258792|NCT00945698|Dietary Supplement|Lipid-based nutrient supplement, 40gM|"560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258793|NCT00945698|Dietary Supplement|Lipid-based Nutrient Supplement, 40gNoM|"560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258794|NCT00945698|Dietary Supplement|Maize-soy flour|"No food supplement during the primary trial period (6 to 18 months of age)
~1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
~Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring"
16258795|NCT00945685|Device|Endymion Imagine™ System for Skin Tightening|"Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed):
~Pulse energy (J);
~RF frequency (1MHz);
~Pulse duration (30 sec);
~Treatment hand piece (skin tightening);"
16258796|NCT00945672|Biological|PF-04360365 10 mg/kg|10 mg/kg every 90 days (5 total doses)
16258797|NCT00945672|Biological|PF-04360365 7.5 mg/kg|10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)
16260213|NCT00935792|Drug|alemtuzumab|Given subcutaneously
16258800|NCT00945659|Other|Standard Care|Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
16258801|NCT00945659|Behavioral|CGS + Behavior Therapy|Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
16258802|NCT00945646|Drug|FST-201 (dexamethasone 0.1%) Otic Suspension|Instill four drops times two times a day.
16258803|NCT00945646|Drug|Vehicle|Instill four times two times a day
16258804|NCT00945620|Drug|ropivicaine|30mL containing 300mg ropivicaine 1% with addition of 1:300,000 epinepherine
16258805|NCT00945620|Drug|placebo|Placebo
16258806|NCT00945607|Other|GRT (Guided Relaxation Training)|Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
16258807|NCT00945594|Device|Cystoscopy|A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)
16258808|NCT00945581|Other|Experimental Nutritional Powder Formula|Powder twice a day
16258809|NCT00945581|Other|Placebo comparator|Powder twice a day
16258810|NCT00945568|Drug|Aminoleban EN|benefits of this drug for patients who undergoing liver resection for HCC
16258811|NCT00945555|Drug|Antibacterial agent for the treatment of febrile neutropenia|The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order
16258812|NCT00945542|Other|Massive transfusion protocol|"Patients randomized to this arm will be transfused based on a pre-defined massive transfusion protocol. Blood bank will release blood a pre-defined packages. Blood will be received in aliquots containing 4 units off FFP, 1 pool of buffy coat platelet (4 units) and 4 units of RBC. As discussed previously, this would correspond to an FFP:RBC transfusion ratio of 1:1.
~Patients randomized to the study protocol will be receiving the FFP and PTL at pre-defined ratios to RBC (1:1:1) up to 12h of hospitalization or earlier if cessation of the massive transfusion requested at the discretion of the treating physicians."
16258813|NCT00945542|Other|Standard of care|Patients randomized to this arm will be treated as per Sunnybrook's current standard of care massive transfusion protocol. Crystalloid and red cell transfusions are performed to maintain volume status, and to maintain haemoglobin levels above 70 g/L. FFP is transfused based in 3-4 unit aliquots, for INR>1.5. Platelets are transfused 1 pool at a time (4 units Buffy coat platelets) to maintain platelet counts above 50 x 109/mL. Cryoprecipitate is transfused 8-12 units at a time to keep fibrinogen above 0.8 gram/L.
16258814|NCT00945529|Drug|inhaled nitric oxide|Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
16258815|NCT00945516|Device|Bona stent® (Flared end FCSEMS)|Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
16258816|NCT00945516|Device|Hanarostent® (Anchoring FCSEMS)|Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
16258817|NCT00945503|Drug|GSK1018921|GSK1018921 is a GT1 recepor antagonist
16258818|NCT00945490|Drug|NX-1207|Single intraprostatic injection of 2.5 mg NX-1207
16258819|NCT00945490|Drug|Placebo|Single intraprostatic injection of placebo
16258820|NCT00945477|Drug|Pazopanib (GW786034)|Pazopanib 800 mg daily x 12 weeks
16258821|NCT00945464|Other|Blood/saliva samples, historic breast imaging|Subjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports.
16258822|NCT00945451|Device|CK|Cyberknife Irradiation
16258823|NCT00945438|Biological|Influenza virus vaccine 2009-2010 formulation|0.1 mL, Intradermal
16258824|NCT00945438|Biological|Influenza virus vaccine 2009-2010 formulation|0.5 mL, Intradermal
16258825|NCT00945425|Drug|AZD7325|oral capsule, once or twice daily, 7 days
16258826|NCT00945425|Drug|Placebo|oral capsule, once or twice daily, 7 days
16258827|NCT00945412|Device|Micropolysaccharide Hemospheres (Arista)|"MPH is applied as an aerosolized powder which is applied to the bleeding fossa, immediately after suctioning the freshly completed tonsillotomy site to expose the tonsil bed. A separate aerosolizer is used for each patient in order to maximize uniformity per standard dose applied. Each initial dose remains in situ for up to 60 seconds in an attempt to achieve complete hemostasis with a single dose. (Prior data from MPH use has shown that 30-60 seconds is the time typically required for hemostasis for diffuse, non-arterial bleeds.) If there is persistent bleeding after this timeframe, then the bed is irrigated and suctioned and a second equivalent dose is applied.
~No pressure pack and no oxymetazoline or other topical vasoconstrictor is applied in either group during these initial hemostatic steps, since they are potential confounders of hemostatic effect."
16258828|NCT00945412|Device|Electrocautery (Monopolar suction cautery)|Monopolar suction electrocautery is used at 20 Watts. Cautery is applied with a light surface touch until bleeding has stopped. In addition, any prominent visible vessels are cauterized.
16258829|NCT00945399|Procedure|CARTIPATCH® procedure|Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
16258830|NCT00945399|Procedure|Microfracture|Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
16258831|NCT00945373|Drug|calcium dobesilate|2.5% gel
16258832|NCT00945373|Procedure|pulsed dye laser|All study patients will be treated with 595 nm PDL (Vbeam, Candela Corp, Wayland, Mass) with an initial test spot using a fluence of 10 J/cm2, 7-mm spot size and 1.5-ms pulse duration. Based on the biologic response of the test area, the fluence will accordingly be adjusted up or down to find a fluence that produces a transient purpuric effect for a few seconds only.
16258833|NCT00945360|Drug|Letrozole (aromatase inhibitor)|Letrozole at a dose of 2.5 mg/day for 8 weeks.
16258834|NCT00945347|Drug|Miglustat|Nasal instillation of miglustat
16258835|NCT00945347|Drug|Placebo|Nasal instillation of placebo matching in appearance with the Miglustat instillation
16258836|NCT00945334|Drug|Neomycin|500 mg po bid for 14 days
16258837|NCT00945334|Drug|Placebo|placebo for 14 days tid
16258838|NCT00945334|Drug|Rifaximin|550 mg po tid
16258839|NCT00945321|Drug|aprepitant 165 mg|Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
16258840|NCT00945321|Drug|Comparator: aprepitant 185 mg|Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
16258841|NCT00945321|Drug|Comparator: fosaprepitant 150 mg|Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
16258842|NCT00945321|Drug|Comparator: aprepitant with food|Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.
16258843|NCT00945308|Drug|Eptifibatide|Intracoronary injection of Eptifibatide injected in two consecutive bolus of 180 mcg/kg each, followed immediately by continuous infusion of 2 mcg/kg/min for 12 hs.
16258844|NCT00945308|Drug|Eptifibatide|Intravenous injection of Eptifibatide in two consecutive boluses of 180 mcg/kg followed by continuous intravenous injection dosing 2 mcg/kg/min for 12 hours
16258845|NCT00945295|Drug|Botulinum toxin type A, BoNT-A|Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
16258846|NCT00945295|Other|Rehabilitation Therapy|Rehabilitation therapy
16258847|NCT00945282|Drug|GSK2248761|GSK2248761 30 mg capsule once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class.
16258848|NCT00945282|Drug|Lopinavir/ritonavir|Lopinavir 400 mg and ritonovir 100 mg every 12 hours for 28 days. Lopinavir/ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class. Kaletra is a trademark of Abbott Laboratories.
16258849|NCT00945282|Drug|HAART|Highly Active Antiretroviral therapy of the doctor's choice.
16258850|NCT00945282|Drug|Placebo|Placebo is a capsule with no drug in it.
16258851|NCT00945282|Drug|GSK2248761|GSK2248761 10 mg -20 mg or 40 mg - 90 mg once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class.
16258852|NCT00945269|Biological|therapeutic autologous lymphocytes|Given IV
16258853|NCT00945269|Biological|aldesleukin|Given SC
16258854|NCT00945269|Biological|denileukin diftitox|Given IV
16258855|NCT00945269|Procedure|biopsy|Optional correlative studies
16258856|NCT00945269|Other|immunohistochemistry staining method|Correlative studies
16258857|NCT00945269|Other|laboratory biomarker analysis|Correlative studies
16258858|NCT00945269|Genetic|polymerase chain reaction|Correlative studies
16258859|NCT00945256|Other|Aerobic Exercise|45 minuties of treadmill walking was completed at 40% VO2 peak
16258860|NCT00945256|Drug|Sodium Nitroprusside|Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
16258861|NCT00945256|Dietary Supplement|Amino Acid Drink|7.5 gram Amino Acid drink
16258862|NCT00945243|Device|Zero-P|The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
16258863|NCT00945230|Procedure|Re-section of a large left anterior cranial fossa meningioma|Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma
16258864|NCT00945204|Other|intermediate care clinics (ICCs)|The ICCs will be community based. Their aim is to support primary care, particularly smaller practices that have the most difficulty achieving good control. They will comprise a multidisciplinary team, and be led by specialist nurses who will place an emphasis on education and self management. Medical care will be provided by a diabetologist. The ICC will work closely with hospital based specialist teams and community services including podiatry and dietetics. Team members will work to local guidelines, adapted from national evidence based guidelines. Guidelines for referral to the ICCs will be common across all sites, and will include people with poorly controlled type 2 diabetes and those with poorly controlled cardiovascular risk factors.
16258865|NCT00945191|Drug|CS-1008|CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6
16258866|NCT00945191|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles
16258867|NCT00945191|Drug|Carboplatin|Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles
16258868|NCT00945178|Drug|AZD1386|Single ascending and multiple (twice daily) oral doses, capsule
16258869|NCT00945178|Drug|Placebo for AZD1386|Single ascending and multiple (twice daily) oral doses, capsule
16258870|NCT00945178|Drug|Naproxen|Tablet, single oral dose, 500mg
16258871|NCT00945178|Drug|Placebo for Naproxen|Tablet, single oral dose
16258872|NCT00945165|Behavioral|Exercise intervention|various exercise characteristics
16258873|NCT00945165|Behavioral|No exercise|No exercise control period
16258874|NCT00945152|Drug|Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)|Topical use for open wounds culturing out MRSA. One to three applications of the compound over a weeks time. Consists of Vancomycin 1.25-1.50% in a complex gel formulation.
16258875|NCT00945152|Drug|Placebo, complex gel formulation without Vancomycin|Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin
16258876|NCT00945139|Drug|Doxil|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1
16258877|NCT00945139|Drug|Avastin|First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression
16258878|NCT00945126|Other|Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS|The aim is to transplant 7x106 CD34+/kg of recipient body weight.
16258879|NCT00945113|Behavioral|One-week speech therapy group|One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer
16258880|NCT00945100|Device|Eye Patch|42 hours patching per week (averaging 6 hours patching daily)
16258881|NCT00945100|Device|Eye Patch|2 hours patching daily
16258977|NCT00944398|Dietary Supplement|Zinc fortified food|Daily consumption
16258978|NCT00944398|Dietary Supplement|Zinc supplement|Liquid supplement containing zinc sulfate
16258979|NCT00944398|Other|Placebo supplement|Liquid placebo supplement
16258882|NCT00945087|Other|Bacteriophage preparation|Bacteriophage lysates or purified phage formulations containing phages lytic for Staphylococcus, Enterococcus, Pseudomonas, Escherichia, Klebsiella, Proteus, Citrobacter, Acinetobacter, Serratia, Morganella, Shigella, Salmonella, Enterobacter, Stenotrophomonas, or Burkholderia strains isolated from a patient used for oral, rectal and/or topical application.
16258883|NCT00945074|Other|Standard Acupuncture/Moxibustion (fixed protocol)|Acupuncture/Moxibustion
16258884|NCT00945074|Other|Individualized Acupuncture/Moxibustion|Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis
16258885|NCT00945074|Other|Sham/Placebo Acupuncture/Moxibustion|Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active
16258886|NCT00945061|Radiation|intracavitary balloon brachytherapy|Patients undergo brachytherapy
16258887|NCT00945061|Radiation|intraoperative radiation therapy|Patients undergo radiotherapy
16258888|NCT00945048|Device|electrical velocimetry|determination of cardiac output by electrical velocimetry
16258889|NCT00945048|Device|inert gas rebreathing|determination of cardiac output by inert gas rebreathing
16258890|NCT00945048|Device|spirometry|spirometry for testing the ventilatory function
16258891|NCT00945048|Device|cardiac magnetic resonance imaging (CMR)|CMR examination which delivers the hemodynamic reference parameters
16258892|NCT00945035|Drug|etoricoxib|Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
16258893|NCT00945035|Drug|Comparator: etoricoxib|Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
16258894|NCT00945022|Device|wetting lips following surgery using anesthesia|The investigator will position the Lipsus device in accordance with the instructions for use
16258895|NCT00945009|Biological|Dactinomycin|Given IV
16258896|NCT00945009|Drug|Doxorubicin Hydrochloride|Given IV
16258897|NCT00945009|Radiation|Radiation Therapy|Undergo radiation therapy
16258898|NCT00945009|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16258899|NCT00945009|Drug|Vincristine Sulfate|Given IV
16258900|NCT00944996|Drug|SSRI; SNRI; TCA|Tablets or Pills, 1 or 2 per day, more than 2 month
16258901|NCT00944970|Drug|binodenoson|30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
16258902|NCT00944970|Drug|adenosine|30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
16258903|NCT00944957|Drug|Raltegravir for the first 2 weeks|Patient receives raltegravir and efavirenz placebo during the first 2 weeks
16258904|NCT00944957|Drug|Efavirenz for the last 2 weeks|Patient receives efavirenz and raltegravir placebo during the last 2 weeks
16258905|NCT00944957|Drug|Efavirenz for the first 2 weeks|Efavirenz and raltegravir placebo for the first 2 weeks
16258906|NCT00944957|Drug|Raltegravir for the last 2 weeks|Raltegravir and efavirenz placebo for the last 2 weeks
16258907|NCT00944944|Behavioral|limb volume measurements and GCLQ lymphedema symptom assessment questionnaire|Upon obtaining consent, the participants without a history of lower extremity lymphedema will be asked to undergo limb volume measurements to ensure the accuracy of group assignment to the nonlymphedema group. Participants will then be asked to complete the one time GCLQ lymphedema symptom assessment questionnaire. The survey tool and Limb volume (LV) data and feedback from participants about the GCLQ will be collected. We expect the study survey to take approximately 5-10 minutes to complete and 5-10 minutes to collect LV data.
16258908|NCT00944944|Behavioral|GCLQ lymphedema symptom assessment questionnaire|The gynecologic cancer survivors with lymphedema group will have documented lower extremity lymphedema. Participants will be asked to complete a one time assessment, the Gynecologic Cancer Lymphedema Questionnaire to identify lower extremity lymphedema symptoms in gynecologic cancer survivors. They will also be asked to provide feedback about their satisfaction with and the feasibility of the GCLQ as a brief assessment tool that could be used in the clinical care setting.
16258909|NCT00944931|Device|DC Brain Polarization|
16258910|NCT00944918|Drug|fulvestrant|Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
16258911|NCT00944918|Drug|anastrozole|Tablet, oral, once daily until disease progression.
16258912|NCT00944918|Drug|exemestane|Tablet, oral, once daily until disease progression.
16258913|NCT00944905|Biological|MDX-1203|Assigned Interventions: Single dose of MDX-1203 will be administered every 21 days as an intravenous (i.v.) infusion. Subjects will receive one dose of MDX-1203.
16258914|NCT00944892|Drug|REGN475|2 Administrations of REGN475 within 24 weeks.
16258915|NCT00944892|Other|Placebo|Placebo to match REGN475 doses
16258916|NCT00944853|Dietary Supplement|Liquid zinc syrup|Liquid zinc syrup containing 5 mg zinc as zinc sulfate
16258917|NCT00944853|Dietary Supplement|Zinc tablet|Dispersible zinc tablet containing 5 mg zinc
16258918|NCT00944853|Dietary Supplement|Liquid placebo supplement|Liquid placebo supplement containing 0 mg zinc
16258919|NCT00944840|Drug|SP plus amodiaquine|SP plus amodiaquine or placebo at monthly interval during September, October and November
16258920|NCT00944840|Drug|SP placebo plus amodiaquine placebo|monthly treatment with amodiaquine and SP or placebo during September, October and November
16258921|NCT00944827|Dietary Supplement|Green Tea Extract - Catechins|Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
16258922|NCT00944827|Dietary Supplement|Placebo|Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
16258923|NCT00944814|Dietary Supplement|LNS with zinc|Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
16258924|NCT00944814|Dietary Supplement|LNS without zinc|LNS containing no zinc
16258925|NCT00944801|Drug|Pegylated Liposomal Doxorubicine|In the dose escalation phase of the study, PEG-Dox is raised in steps of 5 mg/m2 in a 3-by-3 design, starting with 5 mg/m2 (group 1) up to 20 mg/m2 (group 4). In the phase II part of the study, the targeted dose of 20 mg/m2 is administered up to a cumulative dose of 550 mg/m2 or until tumor progression.
16258926|NCT00944788|Other|qi-gong|Physical activity similar to tai-chi
16258927|NCT00944775|Behavioral|Exercise training|10-month exercise training program during hemodialysis sessions
16258980|NCT00944398|Dietary Supplement|Non-fortified food|Non-fortified complementary food.
16259768|NCT00938977|Device|CPAP|Before and after effect of treatment with CPAP
16258928|NCT00944762|Behavioral|Ecosystem Focused Therapy (EFT)|12 therapist-led sessions over 25 weeks, in which a participant will learn problem-solving skills, the participant's physical environment will be modified, and the family or caregiver will facilitate the participant's adaptation. Active participation in treatment and rehabilitation for stroke will also be targeted by EFT's problem-solving approach, creating synergy among treatments.
16258929|NCT00944762|Behavioral|Education in stroke and depression|Information and resources on living with stroke and depression will be provided in 12 sessions over 25 weeks.
16258930|NCT00944749|Drug|h-ATG (ATGAM )|
16258931|NCT00944749|Drug|Cyclosporine (Gengraf )|
16258932|NCT00944736|Dietary Supplement|VSL#3|1 packet BID
16258933|NCT00944736|Dietary Supplement|Placebo|1 inactive packet BID
16258934|NCT00944723|Dietary Supplement|Zinc-fortified bread|Bread made with zinc-fortified wheat flour
16258935|NCT00944723|Dietary Supplement|Zinc supplement|Liquid supplement with zinc
16258936|NCT00944723|Dietary Supplement|Non-fortified bread|Daily consumption of non-fortified bread
16258937|NCT00944723|Dietary Supplement|Placebo supplement|Daily intake of placebo supplement
16258938|NCT00944710|Drug|Atropine|Weekend atropine 1%
16258939|NCT00944710|Device|Plano lens|plano lens over the sound eye
16258940|NCT00944710|Drug|Atropine|Weekend atropine 1%
16258941|NCT00944697|Drug|Oxycodone Naloxone|Oxycodone Naloxone tablets
16258942|NCT00944697|Drug|Placebo tablets|Placebo Oxycodone Naloxone tablets
16258943|NCT00944684|Drug|High ribavirin dose|Ribavirin dose started according to kidney function (usually 1,800mg) and adapted according to plasma level during follow-up
16258944|NCT00944684|Drug|Standard ribavirin dose|Ribavirin dose started at 1,000mg (body weight <65kg) or 1,200mg (body weight equal or >65kg)
16258945|NCT00944671|Drug|famotidine (+) calcium carbonate (+) magnesium hydroxide tablet|A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
16258946|NCT00944671|Drug|Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water|A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
16258947|NCT00944671|Drug|Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water|A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
16258948|NCT00944658|Drug|Apremilast|10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
16258949|NCT00944658|Drug|Placebo (sugar pill)|twice a day
16258950|NCT00944645|Drug|niacin (+) laropiprant (Source 1)|Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
16258951|NCT00944645|Drug|Comparator: niacin (+) laropiprant (Source 2)|Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
16258952|NCT00944632|Drug|ZK 245186|Once daily topical non-occlusive application for up to 4 weeks
16258953|NCT00944632|Drug|Placebo (vehicle ointment)|Once daily topical non-occlusive application for up to 4 weeks
16258954|NCT00944619|Device|Closed loop|Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
16258955|NCT00944619|Device|Conventional insulin pump delivery|Subcutaneous delivery of Novorapid insulin according to usual pump regime
16258956|NCT00944606|Dietary Supplement|Vitamin D|2000-3000 IU Vitamin D daily x 6 weeks
16258957|NCT00944606|Other|Placebo candy|candy gum drops
16258958|NCT00944593|Dietary Supplement|Jejunal Feed|Liquid nutrient (Ensure 200ml (300kcal) over 60 minutes) will be delivered by naso-jejunal feeding tube (previously placed by endoscopy)
16258959|NCT00944593|Dietary Supplement|Normal Saline|200ml Normal Saline 0.9%
16258960|NCT00944580|Biological|MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine|A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.
16258961|NCT00944554|Drug|Varenicline|Varenicline given twice a day or five weeks.
16258962|NCT00944554|Drug|Placebo|Placebo given twice a day or five weeks.
16258963|NCT00944541|Drug|maraviroc|maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
16258964|NCT00944528|Radiation|Radiosurgery|Single dose or radiation in 15Gy, 18Gy or 21Gy
16258965|NCT00944515|Drug|placebo|placebo tablet or syrup 3 days/week
16258966|NCT00944515|Drug|azithromycin|azithromycin 3 days/week
16258967|NCT00944502|Drug|Dexamethasone|"Group A: Vitatonus DEXA injectable:
~1 ampoule intramuscularly every 3 days for 10 days.
~Group B: Vitatonus DEXA tablets:
~1 tablet orally every 8 hours for 10 days.
~Group C: Dexamethasone Injectable:
~1 ampoule intramuscularly every 3 days for 10 days.
~Group D: Dexamethasone tablets:
~1 tablet orally every 8 hours for 10 days."
16258968|NCT00944476|Procedure|Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI exam|In addition to the traditional MRI exam for clinical use, a fat-free MRI based on standard magnetization transfer magnetic resonance imaging will be acquired. Pts will spend 20 extra minutes and 20 minutes total for volunteers in the MRI scanner. Patients/volunteers will complete the MR Screening Questionnaire before the MRI exam.
16258969|NCT00944463|Drug|Gemcitabine+simvastatin|Gemcitabine and simvastatin
16258970|NCT00944463|Drug|Gemcitabine+Placebo|Gemcitabine plus Placebo
16258971|NCT00944450|Drug|Sitagliptin phosphate anhydrous formulation|Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
16258972|NCT00944450|Drug|Comparator: sitagliptin phosphate monohydrate form|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
16258973|NCT00944437|Device|Helmet|Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.
16258974|NCT00944437|Device|Full-face mask|Continuous positive airway pressure for up to 24 h. Initial pressure will be 5 cmH2O, and will be increased by 2-3 cmH2O up to 10 cmH2O, in order to maintain SpO2 ≥90%.
16258975|NCT00944424|Drug|Docetaxel + High dose Vitamin D2|Docetaxel + High dose Vitamin D2
16258976|NCT00944424|Drug|Docetaxel + Standard dose Vitamin D2|Docetaxel + Standard dose Vitamin D2
16260214|NCT00935792|Drug|everolimus|Given orally
16258982|NCT00944372|Drug|Indium In-111 pentetreotide|Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
16258983|NCT00944359|Dietary Supplement|Daily preventive Zn; placebo treatment|7 mg zinc / day and placebo supplement during diarrhea episodes
16258984|NCT00944359|Dietary Supplement|Therapeutic Zn; daily placebo|20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
16258985|NCT00944359|Dietary Supplement|Intermittent Zn; placebo treatment|10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
16258986|NCT00944359|Other|Surveillance control group|Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
16258987|NCT00944346|Drug|Metformin HCl|
16258988|NCT00944333|Drug|Clopidogrel|300-600 loading dose 75 mg/die for 6 months
16258989|NCT00944333|Drug|Clopidogrel|300-600 loading dose 75 mg/die for 12 months
16258990|NCT00944307|Drug|raltegravir|raltegravir 400mg orally once
16258991|NCT00944307|Drug|antacid|aluminum, magnesium, simethicone-containing antacid 30mL orally once
16258992|NCT00944294|Drug|binodenoson|30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
16258993|NCT00944294|Drug|adenosine|30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
16258994|NCT00944281|Dietary Supplement|LNS-Zn5|Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
16258995|NCT00944281|Dietary Supplement|LNS-Zn10|Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
16258996|NCT00944281|Dietary Supplement|LNS-Zn0|20 g of LNS containing 0 mg of zinc and a daily placebo supplement
16258997|NCT00944281|Dietary Supplement|Suppl-Zn5|Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
16258998|NCT00944268|Drug|Passiflora, Crataegus e Salix|Comparison of different pharmaceutics forms of drug
16258999|NCT00944242|Drug|Sertraline|
16259000|NCT00944242|Drug|Sertraline Hydrochloride|
16259001|NCT00944229|Drug|LOVAZA (Omega-3)|LOVAZA 4 gm q24 for 8 weeks Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
16259002|NCT00944229|Drug|Placebo|4 capsules of placebo every 24 hours
16259003|NCT00944216|Drug|Salkera Emollient Foam|
16259004|NCT00944203|Drug|Ipomea pes-caprae ointment|Ipomea pes-caprae ointment will be applied twice a day as an add-on therapy.
16259005|NCT00944190|Behavioral|Self-management intervention|Brief counseling technique, self-management,
16259006|NCT00944190|Behavioral|Education|Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
16259007|NCT00944177|Drug|Metformin HCl|
16259008|NCT00944164|Behavioral|Healthy eating and physical activity|Parent counseling and coaching regarding healthy eating and physical activity habits for their child
16259009|NCT00944164|Behavioral|Safety and injury prevention|Parent counseling and coaching regarding general personal and household safety
16259010|NCT00944151|Procedure|TAP Catheter and Infusion of Study Solution|Subject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in.
16259011|NCT00944138|Behavioral|Relaxation methods|Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm
16259012|NCT00944125|Device|Dual Site LV Pacing|Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
16259013|NCT00944125|Device|BiV Pacing|Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
16259014|NCT00944112|Biological|Restrictive RBC Transfusion|Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.
16259015|NCT00944112|Biological|Liberal RBC Transfusion|Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target Hb concentration of 91-110 g/L during intervention.
16259016|NCT00944099|Behavioral|Behavioral weight loss intervention|both conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program
16259017|NCT00944086|Other|Recruitment Manoeuvre|Recruitment Manoeuvre
16259018|NCT00944073|Biological|Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A|Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral thigh muscle.
16259019|NCT00944060|Other|lifestyle intervention|
16259020|NCT00944047|Drug|nab-paclitaxel|100 MG/M2 IV over 30 minutes once a week for 12 weeks
16259021|NCT00944047|Drug|trastuzumab|4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
16259022|NCT00944047|Drug|Doxorubicin|60 MG/M2 every two weeks for a total of 4 cycles
16259023|NCT00944047|Drug|cyclophosphamide|600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
16259024|NCT00944047|Biological|Growth Factor Support|"All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
~Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician."
16259025|NCT00944047|Procedure|Surgery|"After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
~All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
16259026|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
16259027|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
16259028|NCT00944034|Biological|rMenB+OMV NZ|rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
16259029|NCT00944034|Biological|rMenB+OMV NZ|rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
16259030|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age
16259031|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age
16259032|NCT00944034|Biological|two doses of rMenB+OMV NZ|two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.
16259033|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
16259034|NCT00944034|Biological|two doses of rMenB+OMV NZ|two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age
16259035|NCT00944034|Biological|rMenB+OMV NZ|rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
16259036|NCT00944034|Biological|two doses of rMenB+OMV NZ|two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age
16259037|NCT00944034|Biological|rMenB+OMV NZ with routine vaccinations|rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age
16259038|NCT00944021|Drug|PA-824|50mg
16259039|NCT00944021|Drug|PA-824|100mg
16259040|NCT00944021|Drug|PA-824|150 mg
16259041|NCT00944021|Drug|Rifafour e-275 mg|275 mg
16259042|NCT00944021|Drug|PA-824|200 mg
16259043|NCT00944008|Drug|DepoCyte|
16259044|NCT00943995|Drug|somatropin|0.35 mg/Kg/week divided into 3 doses, each dose being given at the end of the dialysis treatment.
16259045|NCT00943982|Drug|Interferon Gamma 1-b|
16259046|NCT00943969|Procedure|gastric bypass|gastric bypass combines restrictive and malabsorptive procedures
16259047|NCT00943956|Drug|bicalutamide|
16259048|NCT00943956|Drug|everolimus|
16259049|NCT00943956|Drug|leuprolide acetate|
16259050|NCT00943956|Radiation|external beam radiation therapy|
16259051|NCT00943943|Drug|G-CSF|10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days.
16259052|NCT00943943|Drug|Plerixafor|A fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days.
16259053|NCT00943943|Drug|Sorafenib|"First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours).
~Dose Level 0 = 400 mg orally twice daily."
16259054|NCT00943930|Drug|THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC|During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, or d-amphetamine.
16259055|NCT00943917|Other|ITCA 650|ITCA 650 (continuous delivery of exenatide in DUROS)
16259056|NCT00943917|Drug|Exenatide Injection|twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
16259057|NCT00943917|Other|Ex Inj/ITCA 650|twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
16259058|NCT00943904|Device|Interstim implant for SNS|stimulates third sacral nerve root
16259059|NCT00943891|Procedure|Tumor biopsies|
16259060|NCT00943878|Biological|Trivalent inactivated influenza vaccine|Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
16259061|NCT00943878|Biological|Inactivated H1N1 Vaccine|Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle.
16259062|NCT00943878|Drug|Placebo|Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
16259063|NCT00943865|Behavioral|hypocaloric diet|patients received individually tailored hypocaloric diet, with 20% of total calories as fat (with 7-8 % of saturated fats), 50 to 65% carbohydrates and 15% to 20% proteins. Total of calories for each patient calculated assuming the ideal body weight to fulfill a BMI of 25 kg⁄ M2. Total daily amount of calories estimated calculating 30 calories/Kg of ideal weight for each subject. Subjects were advised against consuming high fat snacks or additional fats. Alimentary plans specified the number of servings from each food group, and dairy intake was held constant.
16259064|NCT00943865|Behavioral|Exercise recommendations|Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.
16259065|NCT00943865|Behavioral|Pragmatic diet|Patients received a portable colored handbook with evidence- based recommendations on healthy eating attitudes and pragmatic menus, with low carbohydrates and high protein and vegetables. It included controlled portions (adjusted for individual hand size) for the six meals, with low glucose aliments and whole grains, legumes, yogurt, fruits, olive oils, eggwhite and low fat milk, fiber and a handful of nuts. Portions were tailored according to individual hand size, without calories counting. Beans, farofa and white cheese bread, which are commonly present in Brazilian food, and red meat were allowed, but with portion control.
16260089|NCT00936741|Drug|mifepristone|Mifepristone 300 mg to 1200 mg once daily
16259066|NCT00943865|Behavioral|Pedometer-based fitness (10,000 steps)|Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.
16259067|NCT00943865|Behavioral|Structured assisted exercise (fitness)|They were scheduled for a more structured assisted exercise intervention: three bicycle ergometer sessions per week, under direct supervision of the same trained exercise physiologists in each session. Heart rate monitors were used to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate), as determined by their individual maximal treadmill exercise test. All patients were trained by the same staff, Borg scale was registered in every session and persuasive goal setting was made during exercise sessions
16259068|NCT00943852|Drug|losartan potassium|Single dose losartan 100 mg in one of five treatment periods
16259069|NCT00943852|Drug|Comparator: isosorbide mononitrate (ISMN)|Single dose ISMN 60 mg in one of five treatment periods
16259070|NCT00943852|Drug|Comparator: losartan + ISMN|Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods
16259071|NCT00943852|Drug|Comparator: losartan + ISMN|Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods
16259072|NCT00943852|Drug|Comparator: Placebo|Single dose placebo only in one of five treatment periods
16259073|NCT00943839|Drug|sunitinib malate|
16259074|NCT00943839|Other|laboratory biomarker analysis|
16259075|NCT00943839|Other|pharmacological study|
16259076|NCT00943826|Drug|Bevacizumab|10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
16259077|NCT00943826|Drug|Temozolomide|75 mg/m^2 once daily for 6 weeks, followed by 150-200 mg/m^2 once daily on days 1-5 of six 4 week cycles.
16259078|NCT00943826|Radiation|Radiation therapy|30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
16259079|NCT00943826|Drug|Placebo|Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
16259080|NCT00943813|Behavioral|video-recording and completing a survey|"Video record MD consult before MD has completed Comskill training. Post-Video Recording Survey (5 minutes): This is a 22-item self-report scale that measures patient satisfaction and patient reports of communication behavior (Roter et al 1977). Items are rated using a five-point Likert-type scale ranging from 1, I disagree completely  to 5, I agree completely ."
16259081|NCT00943800|Drug|Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)|Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
16259082|NCT00943800|Procedure|Stem Cell Transplant|Infusion of haploidentical donor, umbilical cord blood
16259083|NCT00943800|Procedure|Stem Cells Collections|Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
16259084|NCT00943800|Drug|Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)|Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
16259085|NCT00943800|Drug|Fludarabine, Busulfan, and ATG|Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.
16259086|NCT00943787|Procedure|Hyperinsulinemic, euglycemic and hypoglycemic clamp|At 21:30h, an overnight insulin infusion was titrated to control the subjects' BG overnight between 100 and 150mg/dL by blood sampling for plasma glucose via a YSI analyzer every 30min and adjusting the rate of insulin infusion as needed. At the beginning of the clamp, the overnight insulin was replaced by an insulin infusion via a Harvard pump given as a 20mU/kg priming over a 10-min period, followed by a constant rate delivery of 1mU/kg/min until the end of the clamp. Blood was sampled for plasma glucose, and glucose was clamped at basal levels for the euglycemic control period of 150min via a variable-rate infusion of 20% dextrose. Then the glucose concentration was lowered at a rate of 1mg/dL/min to a minimum of 50mg/dL, where it was held constant for 30min. Finally, the glucose concentration was increased at a rate of 1mg/dL/min to 90mg/dL, where it was held for an additional 30min. Blood was sampled for epinephrine during euglycemia, hypoglycemia, and recovery.
16259087|NCT00943774|Other|Physiological maneuvers|These healthy subjects undergo physiological testing, which includes aortic augmentation index, pulse wave velocity, orthostatic stress, baroreflex sensitivity (modified Oxford protocol), mental stress, cold pressor test, isometric handgrip, heart rate variability, 24-hour ambulatory blood pressure monitoring.
16259088|NCT00943761|Drug|Vaniprevir 600 mg b.i.d.|Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
16259089|NCT00943761|Drug|Vaniprevir 300 mg b.i.d.|Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
16259090|NCT00943761|Drug|Pegylated interferon|Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
16259091|NCT00943761|Drug|Ribavirin|Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks
16259092|NCT00943748|Drug|deferiprone|A standard dose-escalation phase will be initiated, with a 3 ml of the deferiprone oral solution twice a day (breakfast and dinner) increase every 3 days up to a total of a fixed dose of 9 ml of deferiprone oral solution twice a day corresponding to 30 mg/kg/day in 2 doses
16259093|NCT00943748|Drug|placebo|A standard dose-escalation phase will first be initiated, with a 3 ml of the placebo oral solution twice a day (breakfast and dinner) increase every 3 days up to a total of a fixed dose of 9 ml of placebo oral solution twice a day corresponding to 30 mg/kg/day in 2 doses
16259094|NCT00943735|Drug|Fesoterodine|Fesoterodine 4 mg and 8 mg QD
16259095|NCT00943735|Behavioral|Your Way|early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB
16259096|NCT00943722|Biological|V503|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
16259097|NCT00943709|Biological|insulin glargine recombinant|Given subcutaneously
16259098|NCT00943709|Drug|therapeutic insulin|Given subcutaneously
16259099|NCT00943696|Dietary Supplement|Ingestion of white wine vs. tea during and an alco|4 x 50ml glasses of white wine (12% alcohol) or tea will be taken according to a randomization scheme After the meal 1 x 20ml of Kirsch (40% alcohol) or tea will be taken
16259100|NCT00943683|Drug|montelukast sodium|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
16259101|NCT00943683|Drug|Comparator: Placebo|Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
16259102|NCT00943670|Biological|pertuzumab|Intravenous repeating dose
16259103|NCT00943670|Biological|Trastuzumab emtansine [Kadcyla]|Intravenous repeating dose
16259104|NCT00943657|Biological|Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]|Single intramuscular injection of vaccine
16259105|NCT00943644|Device|Molecular Breast Imaging (MBI)|To determine the sensitivity of MBI
16259106|NCT00943644|Device|CZT semiconductor detectors|Dual headed CZT semiconductor detectors
16259107|NCT00943631|Biological|Inactivated H1N1 Vaccine|Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.
16259108|NCT00943618|Drug|Varenicline|On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).
16259109|NCT00943618|Drug|Bupropion|On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).
16259110|NCT00943618|Other|Placebo|On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.
16259111|NCT00943618|Behavioral|Counseling/Phone Calls|Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.
16259112|NCT00943605|Device|Scalpel and Traditional Electrosurgery|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
16259113|NCT00943605|Device|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
16259114|NCT00943592|Drug|Clofarabine|Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).
16259115|NCT00943592|Drug|Melphalan|Doses ranging from 100 to 140 mg/m2
16259116|NCT00943592|Drug|Campath|20mg/d x5
16259117|NCT00943592|Procedure|Stem Cell Transplant|Infusion of donor, bone marrow and auto.
16259118|NCT00943579|Drug|Kuvan®|Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks.
16259119|NCT00943566|Drug|Sufentanil|Transdermal Delivery System; Apply up to six 3 cm2 sufentanil TDS patches every 3 days for 12 days of observation. The 12 days of observation begin after a 7 day conversion to sustained release morphine sulfate. If the subject continues on the pharmacokinetic portion of the study, an additional 6 days of intervention will be evaluated (at the same dose as the primary efficacy study).
16259120|NCT00943566|Drug|Sustained Release Morphine Sulfate|Sustained Release Morphine Sulfate tablets every 12 hours; up to 400 mg every day for 19 days (7 days of conversion to sustained release morphine sulfate and 12 days of observation)
16259121|NCT00943553|Drug|decitabine Induction Chemotherapy|Arm A - 12 days (5 days of intravenous (IV) decitabine 20 mg/m^2 followed by 7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day)
16259122|NCT00943553|Drug|Induction Chemotherapy|Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day only)
16259123|NCT00943540|Drug|raltegravir QD|Raltegravir 800mg QD
16259124|NCT00943540|Drug|atazanavir|atazanavir
16259125|NCT00943540|Drug|lamivudine (or emtricitabine)|lamivudine (or emtricitabine)
16259126|NCT00943501|Drug|liraglutide|Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
16259127|NCT00943501|Drug|placebo|Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
16259128|NCT00943501|Drug|liraglutide|Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
16259129|NCT00943501|Drug|placebo|Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
16259130|NCT00943488|Biological|Inactivated H1N1 Vaccine|Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.
16259131|NCT00943475|Procedure|circumcision|circumcision by plastbell
16259132|NCT00943462|Radiation|External-beam radiation therapy|60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions
16259133|NCT00943462|Drug|Temozolomide|The chemotherapy will have to be administered in accordance with the protocol used in the CAN-NCIC-CE3 study, which established the current standard for treatment of GBM with the administration of temozolomide as adjuvant therapy at the same time as radiotherapy (clinicaltrials.gov ID NCT00006353).
16259134|NCT00943449|Drug|4SC-201|oral administration
16259135|NCT00943449|Drug|Sorafenib|oral administration
16259136|NCT00943436|Other|Exercise Session|"This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The Exercise Session will consist of the participant coming into the lab and completing 45 min bout of exercise on an exercise bike, followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum."
16259137|NCT00943436|Other|Rest Session|"This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The Rest Session will consist of the participant coming into the lab and completing a 45 min period of reading followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum."
16259138|NCT00943423|Radiation|Involved Field Radiotherapy|IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy
16259139|NCT00943423|Other|No further treatment|
16259140|NCT00943410|Radiation|external beam radiation therapy|Radiation therapy will consist of 50Gy in 2Gy fractions to the breast/chest wall and regional lymphatics for 5 consecutive days up to 5 weeks for surgical candidates and 7 weeks for non-surgical candidates
16259249|NCT00942513|Other|trt 7|Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g
16259141|NCT00943410|Drug|Herceptin|Patients who are already receiving weekly Herceptin® will continue weekly Herceptin®, 2mg/kg IV on day 1 of each week of radiotherapy. Patients who have not been receiving weekly Herceptin® as a component of systemic therapy will begin Herceptin® one week prior to beginning radiotherapy with a loading dose of 4mg/kg followed by weekly Herceptin® at 2mg/kg on day 1 of each week of radiotherapy
16259142|NCT00943397|Drug|montelukast sodium|Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
16259143|NCT00943397|Drug|Comparator: Usual Care|Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
16259144|NCT00943384|Device|chronOS Strip|chronOS strip combined with bone marrow aspirate plus local bone
16259145|NCT00943371|Drug|MK6349|Panel A: MK6349 in single doses beginning at 16 mg and rising to 90 mg in up to four treatment periods Panel B: MK6349 in single doses beginning at 90 mg and rising to 160 mg in up to four treatment periods Panel C: MK6349 in divided doses beginning at 20 mg q.a.c. (before each meal) and rising to 50 mg q.a.c. in up to four treatment periods
16259146|NCT00943371|Drug|Comparator: Placebo to MK6349|Panel A: Placebo to MK6349 in single doses in up to four treatment periods Panel B: Placebo to MK6349 in single doses in up to four treatment periods Panel C: MK6349 in divided doses q.a.c. (before each meal) in up to four treatment periods
16259147|NCT00943358|Biological|MF59 H1N1 vaccine|3.75-7.5ug dose
16259148|NCT00943358|Biological|Plain H1N1 vaccine|7.5-15ug
16259149|NCT00943345|Drug|indometacin|"capsule for oral consumption
~at 22h00 evening before test day: 75 mg
~at 7h30 on the test day: 50 mg This intervention will be applied 4 times (4 arms)."
16259150|NCT00943332|Procedure|femur fracture repair|all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure
16259151|NCT00943319|Drug|Busulfan|Daily intravenous dosing to target AVC
16259152|NCT00943319|Drug|Fludarabine|Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
16259153|NCT00943319|Drug|Campath|All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
16259154|NCT00943319|Procedure|Stem Cell Transplant|Infusion of bone marrow and donors(related/ unrelated).
16259155|NCT00943306|Drug|lomitapide|5-60 mg po every day
16259156|NCT00943293|Drug|Fludarabine|Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3.
16259157|NCT00943293|Drug|Melphalan|Melphalan 140 mg/m2 IV on day -2.
16259158|NCT00943293|Drug|Campath|Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
16259159|NCT00943267|Drug|Drotrecogin alpha|Drotrecogin alpha is given intrabronchially by bronchoscopy at t=0
16259160|NCT00943267|Drug|Saline (NaCl 0.9%)|Normal saline is given intrabronchially by bronchoscopy at t=0
16259161|NCT00943267|Drug|Endotoxin|Endotoxin (4 ng/kg body weight) is given intrabronchially in one subsegment at t=0
16259162|NCT00943267|Procedure|Bronchoscopy|Bronchoscopies are performed at t=0 (for instillation of LPS and Drotrecogin alpha) and at t=6 (for performing a bronchoalveolar lavage)
16259163|NCT00943267|Procedure|Blood sampling|Blood sampling is done by venapuncture at t=0 and t=6
16259164|NCT00943254|Other|High-Tech Education|Patients will be told that they have the metabolic syndrome and will subsequently watch two 10-minute videos on the metabolic syndrome and on getting started with exercise. They also receive all the paper-based educational material as in arm 2
16259165|NCT00943254|Other|Low-Tech Education|Patients will be told that they have the metabolic syndrome and will subsequently receive paper-based educational material on the metabolic syndrome,pre-diabetes, and hypertension. They also receive pamphlets on dietary management of high cholesterol and triglycerides, and the importance of exercise and weight loss.
16259166|NCT00943228|Drug|mycophenolate mofetil|High dose 4gms daily
16259167|NCT00943202|Biological|Inactivated H1N1 Vaccine|Inactivated influenza H1N1 vaccine, 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm or in the anterolateral thigh muscle (1 injection in each arm or each thigh if receiving 2 doses).
16259168|NCT00943202|Biological|Trivalent Inactivated Influenza Vaccine|Licensed seasonal trivalent influenza vaccine (TIV) (2009-2010 season). For subjects greater than or equal to 6 - <36 months, licensed TIV will be administered as a single 0.25 mL intramuscular (IM) injection in the deltoid muscle of the arm or in the anterolateral thigh muscle. For subjects greater than or equal to 36 months - 17 years, licensed TIV will be administered as a single 0.5 mL IM injection in the deltoid muscle of the arm or in the anterolateral thigh muscle.
16259169|NCT00943176|Drug|Modafinil|100 mg tablets of modafinil or matched placebo will be given for a total of 12 weeks. Patients will be instructed to start one capsule once daily (modafinil or placebo), and dose will be titrated according to tolerability and response.
16259170|NCT00943150|Device|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
16259171|NCT00943150|Procedure|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
16259172|NCT00943137|Drug|5-Fluorouracil|"Chemotherapy will be one of the following:
~de Gramont: folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2.
~FOLFIRI: Irinotecan 180mg/m2 on day 1, folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2.
~Modified FOLFOX-6: Oxaliplatin 85mg/m2 on day 1, folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2."
16259173|NCT00943124|Drug|MK0524B (ER niacin (+) laropiprant (+) simvastatin)|Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
16259174|NCT00943124|Drug|MK0524A (ER niacin + laropiprant)|Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
16259175|NCT00943124|Drug|Simvastatin|Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
16259339|NCT00941915|Radiation|SBRT Prostate|Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
16259340|NCT00941889|Drug|Saline|0.5 ml
16259176|NCT00943111|Drug|Eliglustat tartrate|"Primary analysis period (PAP): Eliglustat tartrate capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than (<) 5 nanogram per milliliter [ng/mL] next higher dose was administered whereas if Genz-99067 trough plasma concentration was greater than or equal to (>=) 5 ng/mL same dose was continued. Pharmacokinetic (PK) assessment at Week 2 and 6 were used for dose adjustment after Week 4 and Week 8, respectively.
~Long-term treatment period (LTTP): Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6."
16259177|NCT00943111|Drug|Imiglucerase|"PAP: Imiglucerase intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
~LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. The PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
16259178|NCT00943098|Drug|Diclofenac HPBCD s.c. 75mg/ml|1 single injection at day of dental surgical extraction
16259179|NCT00943098|Drug|Voltarol 75mg/3ml i.m.|1 single injection at day of dental surgical extraction
16259180|NCT00943085|Behavioral|Family-focused therapy|12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. Ongoing medication management from a study psychiatrist will be available.
16259181|NCT00943085|Behavioral|Brief educational treatment|Thorough diagnostic assessment by a study evaluator, separate evaluation by a child psychiatrist, feedback session with parents and child, and provision of reading materials pertinent to managing childhood mood disorders. Ongoing medication management and crisis-oriented family sessions will be available as needed.
16259182|NCT00943072|Biological|VEGF Trap-Eye 2.0mg|Monthly intravitreal injection out to the Week 24 Primary endpoint
16259183|NCT00943072|Drug|Sham|Monthly sham intravitreal injection out to Week 24 Primary Endpoint
16259184|NCT00943059|Drug|Acipimox|A capsula is given with 250mg Acipimox, 3dd; 1 after each meal. This will be done during 14 days.
16259185|NCT00943059|Drug|Cellulosum Mycrocryst|Capsule with cellulosum powder; this has to be taken 3 dd; 1 after each meal during 14 days.
16259186|NCT00943046|Device|Pacemaker therapy|Implantation of the SIELLO pacemaker leads
16259187|NCT00943033|Behavioral|Mindfulness-Based Cognitive Therapy|Mindfulness-Based Cognitive Therapy for the prevention of depressive relapse/recurrence
16259188|NCT00943020|Dietary Supplement|Nutricia PreOp nutritional supplement|nutritional supplement
16259189|NCT00943020|Dietary Supplement|Lipid|Drink
16259190|NCT00943020|Dietary Supplement|Glutamine|Drink
16259191|NCT00943007|Device|Stealth Station|Neuronavigation based on preoperative MRI
16259192|NCT00943007|Device|PoleStar N20|Intraoperative MRI guided surgery
16259193|NCT00942994|Drug|Aliskiren/Amlodipine|"Amlodipine capsule (5 mg)
~Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)"
16259194|NCT00942994|Drug|Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)|"Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)
~HCTZ capsule (12.5 mg, 25mg)"
16259195|NCT00942968|Drug|dalteparin|Daily subcutaneous injection 200IU/kg dalteparin
16259196|NCT00942903|Device|Provox Xtra HME|Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy
16259197|NCT00942890|Device|NMES (EMPI 300PV stimulator) plus standard of care|In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of performing 15 to 20 minute stimulation sessions with a 5-minute patient treatment log, 5 times per week for 12 weeks. During each training session, 15 NMES contractions per leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.
16259198|NCT00942890|Behavioral|TMARP standard of care|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
16259199|NCT00942877|Drug|AZD2171|Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
16259200|NCT00942864|Drug|ranibizumab|ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor
16259201|NCT00942851|Drug|Acetyl-Hexapeptide Topical Treatment|AH-8 containing topical treatment
16259202|NCT00942851|Drug|placebo|topical treatment NOT containing AH-8
16259203|NCT00942838|Drug|Cisplatin|PLATINOL®-AQ (cisplatin injection) is a clear, colorless, sterile aqueous solution, each mL containing 1 mg cisplatin and 9 mg Sodium Chloride, USP. HCl and/or Sodium Hydroxide is added to adjust pH of the solution. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C.
16259341|NCT00941889|Drug|Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine|0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.
16259204|NCT00942838|Radiation|Whole Abdomen Radiotherapy|Whole abdominal radiotherapy will be delivered with an open-field anterior-posterior/posterior-anterior technique. Radiation will be administered in a dose escalating fashion to determine toxicity. The maximal dose of radiation will be defined as a mean midplane dose to the abdomen of 3,000 Gy through parallel-opposed single ports with a 1-cm margin that will cover the entire abdomen including the diaphragm.
16259205|NCT00942825|Drug|CBP501 + Cisplatin + Pemetrexed|"CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
16259206|NCT00942825|Drug|Cisplatin + Pemetrexed|"Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
16259207|NCT00942812|Other|Diarrhea Pack|Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart
16259208|NCT00942812|Other|ORS|ORS has been supplied to diarrheal cases as standard care through the LHW program at community level
16259209|NCT00942799|Drug|Genz-644282 (28-day dosing schedule)|Genz-644282 will be administered as a 60-minute IV infusion. The initial dose of Genz-644282 will be 0.5 mg/m2 and will be administered once weekly for 3 consecutive weeks on Day 1, Day 8, and Day 15 of the 28 day cycle. Each 28-day period will represent one treatment cycle. Study drug will continue to be given until disease progression or unacceptable toxicity is observed.
16259210|NCT00942799|Drug|Genz-644282 (21-day dosing schedule)|The starting dose of Genz-644282 for the 21-day schedule will be prescriptive and will be based on review of available safety data from the 28-day dosing schedule by the Investigator and Sponsor. Patients will receive Genz-644282 once-weekly for 2 consecutive weeks on Day 1 and Day 8 of a 21 day cycle. Each 21-day period will represent 1 treatment cycle. Patients enrolled in subsequent cohorts will receive higher doses until the MTD is established.
16259211|NCT00942773|Drug|Voriconazole|
16259212|NCT00942760|Device|3T MRI|The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.
16259213|NCT00942747|Drug|temsirolimus|Weekly infusion of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months in the case of continuing response to treatment
16259214|NCT00942734|Drug|Erlotinib|One tablet (150 mg) by mouth every day of each 28 day study cycle.
16259215|NCT00942734|Drug|RAD001|1 tablet (5 mg) by mouth every day of each 28 day study cycle.
16259216|NCT00942721|Behavioral|Web-based CBT for PPD|A cognitive behavioral intervention that will provide participants with the following: online interactive tools to clarify their attitudes and reasons for wanting to change, information about some of the symptoms and mechanisms associated with feeling depressed during the postpartum period, and guidance on using behavioral and cognitive strategies proven to help reduce depressive symptoms
16259217|NCT00942708|Drug|Fluoxetine|"Total dose How to take:
~Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID"
16259218|NCT00942695|Other|1.5PD|average American diet plus 1.5 oz per day pistachios
16259219|NCT00942695|Other|3.0PD|average American diet plus 3.0 oz per day pistachios
16259220|NCT00942695|Other|control|average American diet without pistachios
16259221|NCT00942682|Drug|Sorafenib|Taken orally twice daily
16259222|NCT00942682|Drug|RAD001|Taken orally once daily in the morning
16259223|NCT00942669|Device|SleepStrip OTC(TM)|self contained SAS screening device
16259224|NCT00942656|Other|PHVO|base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil
16259225|NCT00942656|Other|CLA|base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid
16259226|NCT00942656|Other|VA|base diet plus 3.0% energy added from vaccenic acid
16259227|NCT00942656|Other|base|base diet containing approximately 0.1% energy of mixed trans fatty acid isomers
16259228|NCT00942643|Device|CPAP machine|a machine delivers positive airway pressure into the upper airway via a nasal mask
16259229|NCT00942617|Drug|Aspirin|40 mg non-enteric coated ASA once daily for 21 + or - 2 days
16259230|NCT00942604|Drug|PEP005 (ingenol mebutate) Gel|two day treatment
16259231|NCT00942604|Drug|Vehicle gel|two day treatment
16259232|NCT00942591|Drug|Interferon beta 1b|
16259233|NCT00942591|Drug|Atorvastatin|
16259234|NCT00942578|Drug|Bevacizumab|15 mg/kg cycle 1 day 1, repeated every 21 days
16259235|NCT00942578|Drug|Lenalidomide|Once daily days 1-14 of every 21
16259236|NCT00942578|Drug|Docetaxel|75 mg/m^2 intravenous (IV) over 60 minutes on cycle 1 day 1, repeated every 21 days (a 3-week cycle)
16259237|NCT00942578|Drug|Prednisone|10 mg orally every day
16259238|NCT00942565|Drug|tramadol/acetaminophen|
16259239|NCT00942565|Drug|acetaminophen|
16259240|NCT00942539|Drug|Midazolam|Intravenous infusion of 0.05 mg/kg of Midalolam
16259241|NCT00942526|Drug|Mycostatin oral suspension|peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days
16259242|NCT00942526|Other|Water|perioperative gargling with water
16259243|NCT00942513|Other|trt 1|Fructose - 14 g; Lactose - 10 g; Sucrose - 16 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
16259244|NCT00942513|Other|trt 2|Fructose - 30 g; Lactose - 10 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
16259245|NCT00942513|Other|trt 3|Fructose - 24 g; Lactose - 8 g; Sucrose - 8 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
16259246|NCT00942513|Other|trt 4|Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
16259247|NCT00942513|Other|trt 5|Fructose - 0 g; Lactose - 0 g; Sucrose - 40 g; Starch - 40 g; Whey Protein Isolate - 0 g; Soy Protein Isolate -40 g
16259248|NCT00942513|Other|trt 6|Fructose - 0 g; Lactose - 40 g; Sucrose - 0 g; Starch - 40 g; Whey Protein Isolate - 40 g; Soy Protein Isolate - 0 g
16259344|NCT00941863|Drug|Sorafenib 200 mg (50-mg tablet)|Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
16259250|NCT00942500|Procedure|Post-conditioning|Coronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade <2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade ≥2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained ≥30%, stent will be deployed.
16259251|NCT00942487|Drug|Nebilet|Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration
16259252|NCT00942487|Drug|Corvitol|Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration
16259253|NCT00942474|Device|Facilitate nerve stimulation lead placement with the nerve access tool|
16259254|NCT00942461|Procedure|Laparoscopic colectomy|Laparoscopic colectomy. Epidural anaesthesia used
16259255|NCT00942461|Procedure|Open colectomy|Open colectomy. Epidural anaesthesia used
16259256|NCT00942448|Drug|Diclofenac HPBCD|1 single injection at day of dental surgical extraction
16259257|NCT00942448|Drug|Diclofenac HPBCD|1 single injection at day of dental surgical extraction
16259258|NCT00942448|Drug|Diclofenac HPBCD|1 single injection at day of dental surgical extraction
16259259|NCT00942448|Other|Placebo s.c.|1 single injection at day of dental surgical extraction
16259260|NCT00942435|Drug|YM150|oral
16259261|NCT00942435|Procedure|mechanical prophylaxis|The investigator will determine the method of mechanical prophylaxis
16259262|NCT00942422|Dietary Supplement|defined green tea catechin extract|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16259263|NCT00942422|Genetic|gene expression analysis|Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
16259264|NCT00942422|Genetic|protein analysis|Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
16259265|NCT00942422|Other|laboratory biomarker analysis|Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
16259266|NCT00942409|Biological|ISF35|Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
16259267|NCT00942396|Device|Full Field Digital Mammogram (Planmed Sophie Nuance)|Full Field Digital Mammogram
16259268|NCT00942370|Device|non invasive mechanomyographic device based on a 3 axes accelerometer|"This biomedical research consists specifically in the simultaneous acquisition of:
~EMG and MMG Signals of rectus abdominis of the abdomen,
~Respiratory flow,
~An electrocardiogram (ECG).
~These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person."
16259275|NCT00942344|Drug|Amlodipine plus Losartan|amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg
16259276|NCT00942344|Drug|Amlodipine|amlodipine 5mg, 10mg
16259277|NCT00942344|Drug|Losartan|Losartan 50mg, 100mg
16259278|NCT00942331|Biological|Bevacizumab|Given IV
16259279|NCT00942331|Drug|Cisplatin|Given IV
16259280|NCT00942331|Drug|Gemcitabine Hydrochloride|Given IV
16259281|NCT00942331|Other|Laboratory Biomarker Analysis|Correlative studies
16259282|NCT00942331|Other|Placebo Administration|Given IV
16259283|NCT00942318|Drug|Detemir insulin, Aspart insulin, Metformin|Insulin doses adapted by patients according to self monitoring blood glucose results.
16259284|NCT00942305|Drug|Brincidofovir|Subjects received their first dose of study drug of brincidofovir (BCV) within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.
16259285|NCT00942305|Drug|Placebo|"Subjects received their first dose of study drug within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.
~Matching placebo administered for each cohort."
16259286|NCT00942292|Dietary Supplement|Lipidem- fish oil emulsion BBraun UK|
16259287|NCT00942292|Procedure|Digital Contrast MRI scan|
16259288|NCT00942266|Drug|fluorouracil|Given IV
16259289|NCT00942266|Drug|leucovorin calcium|Given IV
16259290|NCT00942266|Drug|vorinostat|Given orally
16259291|NCT00942266|Other|pharmacological study|Correlative study
16259292|NCT00942253|Other|Dopamine Agonist and Exercise|Dialysis patients will receive dopamine agonist or placebo for 24 weeks following a 24 weeks period of combined treatment with dopamine agonist or placebo and aerobic intradialytic exercise.
16259293|NCT00942240|Drug|ACU-4429|administered orally once a day for 14 days
16259294|NCT00942240|Drug|matching placebo tablet|administered orally once a day for 14 days
16259295|NCT00942227|Other|Physical therapy rehabilitation|Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
16259342|NCT00941876|Behavioral|Facilitated Referral|Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.
16259296|NCT00942227|Other|Physical therapy rehabilitation|Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine. Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
16259297|NCT00942214|Drug|Natalizumab|300mg, IV, every 4 weeks
16259298|NCT00942201|Drug|Dexamethasone|Single loading dose in ED 0.6 mg/kg, rounded to nearest 2 mg,use 4 mg tabs max dose 16 mg.
16259299|NCT00942201|Drug|Dexamethasone|Firstdose in ED 0.6 mg/kg, rounded to nearest 2 mg, use 4 mg tabs max dose 16 mg; a prescription for second dose as above to be taken on day 3 after discharge
16259300|NCT00942188|Drug|LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
16259301|NCT00942188|Drug|Placebo|Participants received 2 SC injections weekly for 12 weeks.
16259302|NCT00942175|Drug|Clopidogrel|Clopidogrel 75 mg, tablets, orally, once daily days 1-9.
16259303|NCT00942175|Drug|Clopidogrel and Lansoprazole|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily days 1-9.
16259304|NCT00942175|Drug|Clopidogrel and Dexlansoprazole|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily days 1-9.
16259305|NCT00942175|Drug|Clopidogrel and Omeprazole|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily days 1-9.
16259306|NCT00942175|Drug|Clopidogrel and Esomeprazole|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily days 1-9.
16259307|NCT00942162|Biological|Immunotherapeutic GSK2132231A|Intramuscular administration
16259308|NCT00942149|Drug|Daptomycin|single dose of 6 mg/kg of daptomycin
16259309|NCT00942136|Drug|GSK1349572|GSK1349572 250 mg suspension as a single dose. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
16259310|NCT00942136|Drug|GSK1349572|GSK1349572 50 mg tablets as a single dose on three separate occasions. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
16259311|NCT00942136|Drug|Placebo|Placebo Suspension as a single dose.
16259312|NCT00942136|Drug|Omeprazole|Omeprazole 40 mg once a day for 5 days. Omeprazole is approved by the FDA currently to reduce stomach acid, treat stomach ulcers, and gastroesophageal reflux disease.
16259313|NCT00942110|Device|CPAP treatment|maintains upper airway patency and minimizes the obstructive events
16259314|NCT00942097|Drug|Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos|CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.
16259315|NCT00942097|Drug|Homeopathy and Nutritional oriented diet|Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.
16259316|NCT00942084|Drug|Acyclovir|"Protocol V2 & up: Acyclovir 7mg/ml to be administered IV at 10 mg/kg IV q12 or 20 mg/kg IV q12 or 20 mg/kg IV q8 for a total of 6-9 doses(3 days).
~Protocol V1: Acyclovir 5 mg/mL to be administered IV at 500 mg/m2 IV q8h for a total of approximately 15 doses (10 days)."
16259317|NCT00942071|Biological|MVA-NP+M1|1. Intradermal injection at 5 x 10^7 pfu at day 0
16259318|NCT00942071|Biological|MVA-NP+M1|2.Intramuscular injection at 5 x 10^7 pfu/ml at day 0. Intramuscular injection at 2.5 x 10^8 pfu/ml at day 0
16259319|NCT00942071|Biological|MVA-NP+M1|3.Intramuscular injection at 1.5 x 10^8 pfu/ml at day 0
16259320|NCT00942058|Other|Serum and urinary CA9 level|Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
16259321|NCT00942045|Biological|Biologic - Osteocel Plus|Osteocel Plus
16259322|NCT00942006|Drug|doxycycline|100 mg bid, 14 days
16259323|NCT00942006|Drug|ceftriaxone|2g x 1 iv, 14 days
16259324|NCT00941993|Device|Iontophoresis System (Acclarent)|Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
16259325|NCT00941980|Biological|Osteocel Plus|biologic
16259326|NCT00941967|Drug|gemcitabine hydrochloride|Given IV
16259327|NCT00941967|Drug|oxaliplatin|Given IV
16259328|NCT00941967|Drug|sorafenib tosylate|Given orally.
16259329|NCT00941954|Behavioral|Structured Education|The intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months.
16259330|NCT00941954|Behavioral|Written Information|Control subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD.
16259331|NCT00941941|Procedure|Non-mesh Hernia Repair|Non-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external
16259332|NCT00941941|Procedure|Mesh Hernia Repair|Mesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material.
16259333|NCT00941928|Drug|Epratuzumab|360 mg/m^2 once a day by vein on Day -4, Day -1 and Days 3, 6, 10, 13 and 17.
16259334|NCT00941928|Drug|Fludarabine|25 mg/m^2 once a day by vein on Day -6 through Day -2 over 30 minutes.
16259335|NCT00941928|Drug|Cyclophosphamide|60 mg/kg once a day by vein on Days -5 and -4 over 2 hours.
16259336|NCT00941928|Drug|Mesna|12 mg/kg by vein 5 times per day on Days -5 and -4 over 15 minutes.
16259337|NCT00941928|Procedure|Infusion of NK cells|Transplant of Haploidentical NK cells by vein on Day 0.
16259338|NCT00941928|Drug|Interleukin-2|Subcutaneous injections three times a week for 9 doses on Days 0 to 21.
16259343|NCT00941863|Drug|Sorafenib 100 mg (50-mg tablet)|Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
16259345|NCT00941863|Drug|Sorafenib 400 mg (50-mg tablet)|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
16259346|NCT00941863|Drug|Sorafenib 400 mg (200-mg tablet)|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
16259347|NCT00941863|Drug|Sorafenib 400 mg (Expansion)|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
16259348|NCT00941850|Procedure|Upgrade to triple ventricular site CRT|Patients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced).
16259349|NCT00941837|Dietary Supplement|Olive Oil, Palm Olein Oil, Coconut Oil|Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
16259350|NCT00941824|Drug|mycophénolate acid|"Day 0 to Day 7, 720 mg twice daily
~Day 8 to Day 30, 540 mg twice daily
~Day 30 to Day 90, 360 mg twice daily"
16259351|NCT00941811|Drug|Imiquimod|Local Imiquimod three times weekly for 16 weeks
16259352|NCT00941798|Drug|QMF149 Twisthaler®|Once daily via multi-dose dry-powder inhaler
16259353|NCT00941798|Drug|Mometasone Twisthaler®|Once daily via multi-dose dry-powder inhaler
16259354|NCT00941785|Drug|DHA-PQ|"Three monthly administrations of Duocotexcin (DHA-PQ):
~dihydroartemisinin 2.1mg/kg and piperaquine phosphate 16.8 mg/kg once daily for three days"
16259355|NCT00941785|Drug|SP-AQ|"Three monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine:
~One dose of Sulfadoxine 25mg/kg and pyrimethamine 1.25mg/kg Three daily doses of amodiaquine phosphate 10mg/kg"
16259356|NCT00941772|Other|Ultrasonography|Verify nasogastric tube placement with ultrasonography and compare its accuracy with plain radiography
16259357|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259358|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259359|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259360|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259361|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259362|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259363|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259364|NCT00941746|Biological|PG110|Single, slow intravenous infusion
16259365|NCT00941746|Biological|Placebo|Single, slow intravenous infusion that matches PG110 in appearance
16259366|NCT00941733|Device|IN.PACT Amphirion|Balloon Angioplasty
16259367|NCT00941733|Device|Standard PTA|Balloon Angioplasty
16259368|NCT00941720|Drug|busulfan|IV busulfan 0.8 mg/kg every 6 hours x 16 doses
16259369|NCT00941720|Drug|cyclophosphamide|IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
16259370|NCT00941720|Procedure|autologous hematopoietic stem cell transplantation|infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0
16259371|NCT00941707|Drug|JNJ 38518168|JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.
16259372|NCT00941707|Drug|Placebo|Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.
16259373|NCT00941694|Behavioral|Self management intervention|Intervention arm will receive 6 group or individual sessions over a 7 week period
16259374|NCT00941694|Behavioral|placebo group|3 phone calls not related to asthma self-management
16259375|NCT00941681|Drug|CK-1827452|50 mg MR CK-1827452 BID for 10 days
16259376|NCT00941681|Drug|CK-1827452|37.5 mg IR CK-1827452 TID for 10 days
16259377|NCT00941681|Drug|CK-1827452|100 mg MR CK-1827452 BID for 10 days
16259378|NCT00941668|Drug|Triclosan/Copolymer/fluoride toothpaste|Twice daily usage
16259379|NCT00941668|Drug|sodium monofluorophosphate toothpaste|Twice daily usage
16259380|NCT00941655|Drug|Oxaliplatin|"Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.
~Systemic chemotherapy - Oxaliplatin 85 mg/m^2 over 120 minutes,"
16259381|NCT00941655|Drug|Irinotecan|Irinotecan 165 mg/m^2 IV over 90 minutes
16259382|NCT00941655|Drug|5-Fluorouracil|"Surgery and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes.
~systemic chemotherapy -3200 mg/m^2 continuous intravenous over 48 hours."
16259383|NCT00941655|Drug|Leucovorin|"surgery and heated intraperitoneal chemotherapy -20 mg/m^2 intravenous over 5 minutes.
~systemic chemotherapy - 200 mg/m^2 intravenous over 120 minutes."
16259384|NCT00941655|Procedure|Gastrectomy and/or metastasectomy|"Gastrectomy: tumor resection and a bypass; palliative treatment for pain, bleeding, obstruction and/or if deemed in the best interest of the patient.
~Metastasectomy: anatomical segmental resection to render the patient no evidence of disease (NED) with at least 1cm negative margins when possible, followed by systemic chemotherapy."
16259385|NCT00941642|Drug|Lovaza|Approximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration.
16259386|NCT00941642|Drug|placebo control|Approximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration.
16259387|NCT00941629|Behavioral|Cognitive Processing Therapy (CPT)|Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.
16259388|NCT00941629|Behavioral|Cognitive Processing Therapy (CPT)|Provision of Cognitive Processing Therapy over teleconference network (telemental health; telehealth)
16259389|NCT00941616|Biological|Biostate®|80 IU vWF/kg administered as a bolus intravenous infusion on Day 1 and approximately Day 180
16259390|NCT00941616|Biological|Biostate®|Frequency and dose will be determined by the Investigator based on the subjects clinical condition, previous VWF concentrate requirements, response to therapy, weight and reason for usage.
16259391|NCT00941603|Drug|SCH 900271 15mg|oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
16259392|NCT00941603|Drug|SCH 900271|oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
16259393|NCT00941603|Drug|SCH 900271|oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
16259394|NCT00941603|Drug|SCH 900271|oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
16259395|NCT00941603|Drug|SCH 900271|oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
16259396|NCT00941603|Drug|Placebo|oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.
16259397|NCT00941577|Drug|AIR645|AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
16259398|NCT00941577|Drug|Physiologic saline solution|Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
16259399|NCT00941564|Other|Infant Formula milk based|Consume ad lib
16259400|NCT00941564|Other|Infant formula milk based|consume ad lib
16259401|NCT00941551|Drug|levothyroxine|levothyroxine 75-125 ug/day
16259402|NCT00941551|Drug|no levothyroxine|observation only without prophylactic levothyroxine
16259403|NCT00941525|Drug|Latanoprost|1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
16259404|NCT00941499|Drug|HAI Oxaliplatin|140 mg/m^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
16259405|NCT00941499|Drug|5-FU|900-1750 mg/m^2 HAI infusion over 24 hours on Days 1 - 2 of each 21 day cycle.
16259406|NCT00941499|Drug|Bevacizumab|10 mg/Kg by vein on Day 1 of 21 day cycle.
16259407|NCT00941499|Drug|Cetuximab|Loading dose of 250-500mg/m^2 and Maintenance dose of 125-250 mg/m^2 by vein on Day 1 of 21 day cycle.
16259408|NCT00941499|Drug|Leucovorin|200 mg/m^2 by vein on Days 1 and 2 of each 21 day cycle.
16259409|NCT00941499|Drug|5-FU|300-400 mg/m^2 bolus + 600-1000 mg/m^2 infusion over 22 hours on Days 1-2 of each cycle.
16259410|NCT00941499|Drug|Bevacizumab|7.5 - 15 mg/Kg by vein on Day 1 of 21 day cycle.
16259411|NCT00941486|Drug|FST-100 Ophthalmic Suspension|FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
16259412|NCT00941486|Drug|Placebo|A regimen of 2 drops 4 times a day while awake for 5 days.
16259413|NCT00941473|Drug|Triamcinilone (kenalog)|Epidural steroid injection of 80mg of Triamcinilone.
16259414|NCT00941460|Drug|Temozolomide in both arms|initial dose 120 mg/m2 in arm A
16259415|NCT00941460|Drug|Temozolomide in both arms|initial dose 80 mg/m2 in arm B
16259416|NCT00941447|Behavioral|Dietary|All participants in the investigation will receive a standard 12-week behavioral intervention with seven 30-45 minute phone interventions and education sessions. The intervention includes a reduced caloric prescription (1200-1500 kcal/day),fat gram prescription (30% or less kcals from fat) and carbohydrate gram prescription (150-190 grams).
16259417|NCT00941447|Behavioral|Physical Activity|There is a physical Activity of 150 minutes/week of moderate-intense physical activity.
16259418|NCT00941447|Behavioral|Self-Regulatory Approaches|Participants in this arm will receive extensive feedback based on their self-monitoring diary in which the researcher will be reinforced in areas that they are doing well in regarding their blood glucose and also assist in problem solving in areas that need improvement.
16259419|NCT00941434|Dietary Supplement|RUTF|Children with severe malnutrition will be treated with a daily dose of RUTF till their weight for age z scores no longer fall in severe malnutrition group
16259420|NCT00941421|Device|oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy|each patient receive one OVC and one OGDFE the same day
16259421|NCT00941408|Procedure|Diagnostic tumor core biopsy|
16259422|NCT00941395|Other|Survey Administration|Complete surveys
16259423|NCT00941382|Drug|Sibutramine-Metformin|sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
16259424|NCT00941382|Drug|Sibutramine|15 mg per day for 180 days
16259425|NCT00941382|Drug|Metformin|Metformin 850 mg per day for 180 days
16259426|NCT00941369|Drug|Insulin Glargine (HOE901)/NPH Insulin|"Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time
~Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician
~The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day.
~The dose adjustments will be based on the results of self-monitoring."
16259427|NCT00941356|Dietary Supplement|Bio-K+ CL1285|2 capsules per day before breakfast
16259428|NCT00941356|Dietary Supplement|Placebo|2 capsules per day before breakfast
16259429|NCT00941343|Drug|Alfuzosin (XATRAL® - SL770499)|One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed
16259430|NCT00941330|Drug|Exemestane|25 mg daily by mouth for 6 to 12 months.
16259431|NCT00941330|Drug|Docetaxel|Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
16259432|NCT00941330|Drug|Cytoxan|Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
16259433|NCT00941317|Device|Pathformer (micro-drilling device)|The micro-drilling device drills the nail with a prespecified diameter drill bit and to a prespecified depth in the nail, using skin impedance (also referred to as equivalent resistivity level) as a feedback mechanism for stopping the drilling intervention at a preset trigger level value.
16259434|NCT00941304|Drug|Oxycodone|Single-dose of over-encapsulated oral 5-mg oxycodone capsule
16259435|NCT00941304|Drug|Buprenorphine|Single-dose of buprenorphine HCl buccal film
16259436|NCT00941304|Drug|Placebo Film|Single-dose of placebo buccal film
16259437|NCT00941304|Drug|Placebo Capsule|Single-dose of oral placebo capsule
16259438|NCT00941278|Drug|PH-10 (0.001% Rose Bengal)|PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
16259439|NCT00941265|Drug|levodopa and benserazide|Daily Monday to Friday CAT with Daily Monday to Friday levodopa 100 mg with benserazide 25 mg , in the morning 1 h after breakfast, during 2 weeks .
16259440|NCT00941265|Drug|placebo|Daily CAT Monday to Friday with daily placebo Monday to Friday , in the morning 1 h after breakfast, taken 5 out of 7 days during the 2 weeks of one of the two treatment periods.
16259441|NCT00941252|Drug|Topical imiquimod therapy|therapy consists of treatment with topical vaginal suppositories for 16 weeks, each vaginal suppository contains 6.25mg of imiquimod, frequency (one time a week in treatment week 1+2, two times a week in treatment week 3+4, three times a week in treatment week 5-16)
16259442|NCT00941239|Drug|metformin ER|850mg daily for 30 days
16259443|NCT00941239|Drug|metformin|850 mg daily for 30 days
16259444|NCT00941213|Device|ultrasound scissors - Harmonic ACE|preparation with ultrasound scissors during operation
16259445|NCT00941213|Device|electroscalpel (Erbe Vio 300; Aesculap AG)|preparation with electroscalpel during operation
16259446|NCT00941200|Biological|Blood collection|
16259447|NCT00941187|Other|diffusion NO/CO method|pulmonary capillary blood volume (Vc), measured by the double diffusion NO/CO method: this method is to inhale during a deep inspiration with a mixture of helium (8-10%), CO (2000 ppm) and NO (20-40 ppm), the O2 (21%)
16259448|NCT00941174|Drug|13C5-Calcium-L-Leucovorin|This drug will be used in a clinical trial the objective of which is to determine whether, and to what extent, a physiological concentration of natural folate is absorbed across the large intestine with an intact microflora.
16259449|NCT00941161|Drug|metformin/glimepiride combination|long acting metformin/glimepiride 1g/2mg
16259450|NCT00941161|Drug|metformin|long acting metformin 1g once a day with fasting glucose 130-199mg/dL or long actin metformin 1g twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL
16259451|NCT00941161|Drug|glimepiride|glimepiride 2mg once a day with fasting glucose 130-199mg/dL, or glimepiride 2mg twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL
16259452|NCT00941148|Drug|Insulin Glargin|
16259453|NCT00941148|Drug|NPH insulin|
16259454|NCT00941148|Drug|Insulin detemir|
16259455|NCT00941148|Drug|metformin|metformin (2000 mg/day)
16259456|NCT00941135|Other|Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab|"Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks
~Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43"
16259457|NCT00941122|Device|Eluted Swab|Comparison of Eluted Swab with AMIES swab for detection of MRSA/VRE
16259458|NCT00941109|Drug|decitabine|Cohort 1: 30 mg oral on Day 1 and 20 mg/m^2 1-hour IV infusion on Days 2-5 of Cycle 1.
16259459|NCT00941109|Drug|decitabine|Cohort 2: 60 mg oral on Day 1 and 20 mg/m^2 1-hour IV infusion on Days 2-5 of Cycle 1.
16259460|NCT00941109|Drug|decitabine|Cohort 3: 120 mg oral on Day 1 and 20 mg/m^2 1-hour IV infusion on Days 2-5 of Cycle 1.
16259461|NCT00941109|Drug|decitabine|Cohort 4: 240 mg oral on Day 1 and 20 mg/m^2 1-hour IV infusion on Days 2-5 of Cycle 1.
16259462|NCT00941096|Drug|Bimatoprost and Bimatoprost/Timolol fixed combination.|Following an appropriate wash-out period, participants were given a 5-week long treatment with Bimatoprost 0.03% once daily in the evening followed by a further 5-week long treatment with the Bimatoprost 0.03%/Timolol 0.5% fixed combination administered in the evening.
16259463|NCT00941083|Drug|Raltegravir (Use RAL as a simplification strategy)|RAL QD: RAL 800 mg/24 hs
16259464|NCT00941083|Drug|Raltegravir (Use RAL as a simplification strategy)|RAL BID 400 mg/12 hs
16259465|NCT00941083|Drug|Raltegravir (Use RAL as a simplification strategy)|RAL BID to QD
16259466|NCT00941070|Drug|triapine|Given IV
16259467|NCT00941070|Drug|cisplatin|Given IV
16259468|NCT00941070|Radiation|external beam radiation therapy|Undergo pelvic external beam radiation therapy
16259469|NCT00941070|Procedure|quality-of-life assessment|Ancillary studies
16259470|NCT00941070|Other|questionnaire administration|Ancillary studies
16259471|NCT00941070|Radiation|fludeoxyglucose F 18|Undergo FDG-PET/CT
16259472|NCT00941070|Procedure|positron emission tomography|Undergo FDG-PET/CT
16259473|NCT00941070|Procedure|computed tomography|Undergo FDG-PET/CT
16259474|NCT00941057|Drug|BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium|Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
16259475|NCT00941057|Drug|BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)|Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days
16259476|NCT00941057|Drug|BAY 86-7660,levomefolate calcium|Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
16259477|NCT00941044|Device|Neurally adjusted ventilatory assist|application of non-invasive NAVA in healthy volunteers
16259478|NCT00941031|Drug|AIN457|
16259479|NCT00941031|Drug|AIN457A|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9"
16259480|NCT00941031|Drug|AIN457A|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5"
16259481|NCT00941031|Drug|Placebo|"Placebo - Placebo: Placebo administered at weeks 1, 2, 3, 5, 9"
16259482|NCT00941018|Drug|RX-10001|RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
16259483|NCT00941005|Device|Electroacustimulation|Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
16259484|NCT00940992|Drug|DER 45 EV|Topical application to face for 12 weeks
16259485|NCT00940992|Drug|Vehicle|Topical application to face for 12 weeks
16259486|NCT00940979|Procedure|Application of Integuseal sealant|Microbial sealant (integuseal) applied with a sponge applicator
16259487|NCT00940966|Dietary Supplement|standard ADA diet|standard ADA diet
16259488|NCT00940966|Dietary Supplement|energy restricted very-low carbohydrate diet|energy restricted very-low carbohydrate diet
16259489|NCT00940966|Dietary Supplement|low glycemic diet|restricted ketogenic diet
16259490|NCT00940953|Drug|Budesonide + Azelastine|nasal spray, one spray per nostril at time 0 plus one spray Placebo
16259491|NCT00940953|Drug|Budesonide + Azelastine|nasal spray, one spray of each per nostril at time 0
16259492|NCT00940953|Drug|Placebo|nasal spray, one spray per nostril from each of 2 bottles at time 0
16259493|NCT00940940|Biological|Zostavax (Live attenuated herpes zoster vaccine)|0.6 mL subcutaneous
16259494|NCT00940940|Biological|Placebo vaccine|0.65 mL subcutaneous
16259495|NCT00940927|Drug|albuterol|Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)
16259496|NCT00940914|Drug|ioflupane 123I (DATSCAN®)|One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
16259497|NCT00940901|Drug|sildenafil|sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2)
16259498|NCT00940901|Other|placebo|placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)
16259499|NCT00940888|Device|SJ4 connector and RV high voltage SJ4 lead|Standard of care implantation of SJ4 device system
16259500|NCT00940875|Drug|erlotinib [Tarceva]|150mg po on days 15-28 of each 4 week cycle
16259501|NCT00940875|Drug|gemcitabine|1250mg/m2/day on days 1 and 8 of each 4 week cycle
16259502|NCT00940875|Drug|gemcitabine|1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
16259503|NCT00940862|Biological|adalimumab|Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
16259504|NCT00940862|Device|UVB Phototherapy|This intervention can be applied alone or in combination with topical treatment. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening.
16259505|NCT00940862|Other|Topical treatment|"This intervention can be applied alone or in combination with UVB phototherapy. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening. The investigator will prescribe to patients randomized in this arm a select topical product from the list:
~Calcipotriol, Calcipotriene, Dovonex, Tazorac, Tazarotene Anthralin, Corticosteroids."
16259506|NCT00940849|Dietary Supplement|Plant sterol containing drink|The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
16259507|NCT00940849|Dietary Supplement|Standard macaroni meal|The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
16259508|NCT00940836|Drug|Resfenol|Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine. Patients will receive up to five capsules a day.
16259509|NCT00940836|Drug|Placebo|Patients in this group will receive placebo capsules up to five times a day, with the exact same taste and appearance as the active comparator.
16259510|NCT00940836|Drug|Co interventional acetaminophen|All patients received, along with the assigned intervention, 12 acetaminophen 500mg pills, that they were instructed to take only in case of persisting PAIN or FEVER, up to 4 times a day.
16259511|NCT00940823|Device|Ahmed FP7 Valve|Implantation of Ahmed FP7 Valve to lower intraocular pressure in refractory glaucoma.
16259512|NCT00940823|Device|Baerveldt-350 Tube|Implantation of Baerveldt-350 Tube to lower intraocular pressure in refractory glaucoma.
16259513|NCT00940810|Procedure|Plasma Disc Decompression/Nucleoplasty|"Subjects assigned to the PDD Group will be scheduled to receive the plasma disc decompression procedure using the Coblation® method.
~Similarly to in Conservative Care group, subjects will be followed-up at 2, 8 weeks, 6 and 12 months (calculated from the date of the PDD procedure). The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires."
16259514|NCT00940810|Procedure|Conservative Care (physiotherapy)|"Subjects assigned to the Conservative Care Group will be scheduled to receive physical therapy according to standard and customary care locally.
~Subjects will be followed-up at 2, 8 weeks, 6 and 12 months . (Calculated from the time of first going through the individual training programme).The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires."
16259515|NCT00940797|Drug|DMMET-01|60 days: 30 days; dose 1050.6 mg per day (before dinner)+ 30 days; dose 1050.6 mg twice a day 30 more days (before breakfast ando before dinner)
16259516|NCT00940797|Drug|Placebo|60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)
16259517|NCT00940784|Drug|Clopidogrel (Plavix)|Clopidogrel, aspirin plus hydroxyurea 75mg qd (Plavix) + 81 - 100 mg qd (aspirin) + hydroxyurea
16259518|NCT00940784|Drug|Placebo|Placebo, aspirin (81-100 mg qd) plus hydroxyurea
16259519|NCT00940784|Drug|Aspirin|81-100 mg qd
16259520|NCT00940771|Drug|Boosted Atazanavir|Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.
16259521|NCT00940758|Drug|PEP02|Dose escalation: 50-100 mg/m2 biweekly
16259522|NCT00940745|Device|Stereotactic Aspiration and Thrombolysis|"Device: YL-1 type of intracranial hematoma puncture needle YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL：93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe.
~To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward."
16259523|NCT00940745|Drug|conservative treatment|dehydrating agent, haemostatic In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.
16259524|NCT00940732|Other|Destigmatisation and Mental Health Literacy|"Written material delivered over 2 weeks via the Internet, including mythbusters, debunking common myths around anxiety and depression, as well information about a range of celebrities who have identified themselves as having depression or anxiety. Also contains mental health literacy information."
16259525|NCT00940732|Other|Help-seeking list|List of sources for mental health help-seeking delivered over 2 weeks.
16259526|NCT00940732|Other|Feedback|Written material delivered over 2 weeks via the Internet, including two short self-report measures (Goldberg Anxiety, Goldberg Depression), which will provide feedback to the participant about levels of depression and anxiety.
16259527|NCT00940719|Dietary Supplement|vitamin D3|Oil-based solution, 1 dose of 500 microgram each day, during 3 months.
16259528|NCT00940706|Device|TreadMill|"Each subject will undergo 36 intervention sessions, 3 times a week, 12 weeks. Each session - up to 45 minutes
~TreadMill training: During each session the subject will first exercise with basic stretching and muscle strengthening and then walk on the treadmill. According to the subject's rate of improvement, a therapist will determine the rate of increase in the velocity and slope. The treating therapist will make a written report after each session."
16259581|NCT00940394|Behavioral|psychoeducation group|bi-weekly, 12-session, family psychoeducation group
16259582|NCT00940394|Other|Standard care|Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia
16259529|NCT00940706|Other|Physical activity in groups|"Each subject will undergo 36 intervention sessions, 3 times a week, 12 weeks. Each session - up to 45 minutes.
~Activity Focus Training: this involves performing gross motor activities at exercise stations that involve repetitive, reciprocal and coordinated movements to facilitate strength and endurance conducted by physical therapists and instructing parents or other caregivers to be involved in the program. These activities are performed in a group, having a minimum of 6 children at one time."
16259530|NCT00940706|Behavioral|Monitoring physical activity|Activity monitoring with accelerometers
16259531|NCT00940693|Drug|duloxetine|60 mg capsule once per day for 6 weeks
16259532|NCT00940693|Drug|placebo|one capsule of placebo taken one a day for 6 weeks
16259533|NCT00940680|Drug|Amlodipine plus Losartan|amlodipine/losartan 5/100mg q.d.
16259534|NCT00940680|Drug|Losartan|losartan 100mg q.d.
16259535|NCT00940667|Drug|Amlodipine plus Losartan|amlodipine/losartan 5/50mg q.d.
16259536|NCT00940667|Drug|Amlodipine|amlodipine 5mg q.d.
16259537|NCT00940654|Other|Antipyretic therapy|External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid
16259538|NCT00940641|Drug|AZD7325|IV Dose
16259539|NCT00940641|Drug|AZD7325|oral dose
16259540|NCT00940628|Behavioral|Diet and Exercise|mildly hypocaloric diet and physical exercise
16259541|NCT00940628|Drug|orlistat [Xenical]|120mg po tid
16259542|NCT00940615|Other|aerobic exercise|, participants assigned to the exercise treatment group of the proposed study will participate in an aerobic exercise regimen of brisk walking on a treadmill for a 60 minute interval, three times a week
16259543|NCT00940615|Other|stretching/toning|Individuals in the control group will participate in a low intensity stretching and toning session for 60 minutes, three times a week
16259544|NCT00940602|Drug|Deferasirox|Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
16259545|NCT00940602|Drug|Placebo|Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
16259546|NCT00940589|Drug|Circadin|Prolonged Release melatonin (Circadin) 2mg tablets
16259547|NCT00940589|Drug|Placebo|Matched placebo tablets, with identical features to the Circadin tablets
16259548|NCT00940576|Dietary Supplement|mare´s milk|oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)
16259549|NCT00940576|Other|placebo drink|oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
16259550|NCT00940563|Drug|Imatinib|
16259551|NCT00940550|Drug|Prolonged-release melatonin|2 mg tablet, once.
16259552|NCT00940550|Drug|Temazepam|20 mg capsule, once
16259553|NCT00940550|Drug|Zolpidem|10 mg capsule, once
16259554|NCT00940550|Drug|Placebo to match melatonin, zolpidem and temazepam|Placebo to match melatonin: tablet, once. Placebo to match zolpidem: capsule, once. Placebo to match temazepam: capsule, once.
16259555|NCT00940524|Drug|Dasatinib, Mitoxantrone, Cytarabine|"INDUCTION- Dasatinib† (dose levels 1-3) *continuously Cytarabine 3 g/m2 IV over 3 hours Mitoxantrone 80 mg/m2 IV Myeloid growth factor on day 7 until ANC > 1,000/μl x 2 days Allopurinol 300 mg BID-TID x 7 days (starting 6-12 hours prior to chemotherapy) Dexamethasone 0.1% eye drops q6h while on cytarabine (start prior to the first dose of cytarabine and continuing at least 24 hours after the last dose) IT Methotrexate 12 mg days 2 and 4
~CONSOLIDATION A-Dasatinib† (dose levels 1-3) *continuously Vincristine 2 mg IV Dexamethasone 10 mg/m2/d days 2 to 29, then taper over 10 days Sulfamethoxazole/Trimethoprim 1 DS BID three times weekly days 2 to 29, then BID daily days 30 to 45 IT Methotrexate 12 mg days 8, 15, 22 and 29"
16259556|NCT00940511|Behavioral|Coordinated care|
16259557|NCT00940498|Drug|PF-05212384 (also known as PKI-587)|Intravenous dosing once weekly infusion
16259558|NCT00940485|Drug|entecavir|0.5mg po daily for 8 weeks
16259559|NCT00940485|Drug|entecavir|0.5mg po daily for 48 weeks
16259560|NCT00940485|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc/week for 48 weeks
16259561|NCT00940472|Drug|DMMET-01|90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).
16259562|NCT00940472|Drug|Metformin Hydrochloride|90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)
16259563|NCT00940459|Device|Senofilcon A contact lens (Acuvue Oasys)|Silicone hydrogel contact lens CE-marked for the intended usage.
16259564|NCT00940459|Device|Comfilcon A contact lens (Biofinity)|Silicone hydrogel contact lens CE-marked for the intended usage.
16259565|NCT00940459|Device|Lotrafilcon B contact lens (Air Optix)|Silicone hydrogel contact lens CE-marked for the intended usage.
16259566|NCT00940459|Device|Balafilcon A contact lens (PureVision)|Silicone hydrogel contact lens CE-marked for the intended usage.
16259567|NCT00940459|Device|Etafilcon A contact lens (Acuvue 2)|Hydrogel contact lens CE-marked for the intended usage.
16259568|NCT00940459|Device|Contact lens care system (EasySept)|Contact lens care system CE-marked for the intended usage.
16259569|NCT00940446|Device|Insorb staples|absorbable staples required for wound closure
16259570|NCT00940446|Device|metal staples (Ethicon metal stapler)|wound closure with metal staples
16259571|NCT00940433|Procedure|open properitoneal hernia repair|suprapubic retro-inguinal approach
16259572|NCT00940433|Procedure|Lechtestien hernia repair|onlay mesh repair
16259573|NCT00940433|Procedure|Laparoscopic transperitoneal approach|intraperitoneal insufflation followed by re-exiting to the hernia site
16259574|NCT00940433|Procedure|Laparoscopic totally extraperitoneal approach|avoiding the peritoneum altogether
16259575|NCT00940420|Drug|Copegus (ribavirin)|800 - 1200 mg po daily for 24 weeks
16259576|NCT00940420|Drug|Copegus (ribavirin)|800 - 1200 mg po daily for 48 weeks
16259577|NCT00940420|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc once weekly for 24 weeks
16259578|NCT00940420|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc once weekly for 48 weeks
16259579|NCT00940407|Device|Photobiomodulation (Gentlewaves, Warp 10)|Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.
16259580|NCT00940394|Behavioral|mutual support group|bi-weekly, 12-session, family-led mutual support group
16259583|NCT00940381|Drug|Sirolimus|Beginning dose 3 mg by mouth on Day 1, and 1 mg on Days 2 - 28 for a 28 day cycle.
16259584|NCT00940381|Drug|Cetuximab|Beginning dose 100 mg/m^2 by vein over two hours on Day 1, and 65 mg/m^2 on Days 8, 15 and 22 for a 28 day cycle.
16259585|NCT00940368|Dietary Supplement|Provision of capsules containing ginger powder or placebo|"The patients(children and adolescents) will be provided with Capsules containing either ginger powder or placebo on the three days when they receive chemotherapy.
~For weight category 1(20-40kg),6 capsules are given in three divided doses and the amount of ginger powder administered per day is 1 gram.
~For weight category 2(40-60kg), 5 capsules are given in three divided doses and the amount of ginger powder administered per day is 2 gram."
16259586|NCT00940355|Behavioral|Intervention pulmonary nurse|The intervention is conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, and increasing motivation to engage in additional treatment, and improving health status.
16259587|NCT00940342|Drug|GM-CSF (Sargramostim)|250 mcg injection under the skin, three times a week for eight weeks.
16259588|NCT00940342|Drug|Rituximab|375 mg/m^2 administered intravenously once weekly for four weeks
16259589|NCT00940329|Drug|Roflumilast|Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)
16259590|NCT00940329|Drug|Roflumilast|Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
16259591|NCT00940316|Biological|panitumumab|Given intravenously 6mg/kg every 2 weeks
16259592|NCT00940316|Drug|erlotinib hydrochloride|Given orally 150mg daily
16259593|NCT00940316|Drug|irinotecan hydrochloride|Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
16259594|NCT00940303|Drug|5-FU|3200mg/m2 continuous iv infusions, day 1 every 2 weeks
16259595|NCT00940303|Drug|bevacizumab [Avastin]|5mg/kg iv infusion, day 1 every 2 weeks
16259596|NCT00940303|Drug|irinotecan|165mg/m2 iv infusion, day 1 every 2 weeks
16259597|NCT00940303|Drug|leucovorin|200mg/m2 iv infusion, day 1 every 2 weeks
16259598|NCT00940303|Drug|oxaliplatin|85mg/m2 iv infusion, day 1 every 2 weeks
16259599|NCT00940290|Other|Graded Clinical Recommendation|Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline
16259600|NCT00940277|Behavioral|Group Counseling|Group counseling
16259601|NCT00940264|Procedure|transvaginal hybrid cholecystectomy|transvaginal hybrid cholecystectomy: using one trans-umbilical 5mm trocar and 2 (one 12mm trocar, one 5-mm trocar)inserted through the posterior colpotomy. Removal of the gallbladder through the transvaginal access.
16259602|NCT00940251|Drug|Mersina|capsule, 3g/day, 3 months
16259603|NCT00940238|Drug|Citalopram Hydrobromide|
16259604|NCT00940225|Drug|XL184|All subjects receive 100 mg XL184 (supplied at 19.7-, 50-, and 60-mg strength capsules) daily for 12 weeks. Subjects with a partial or complete response will continue daily XL184 administration until disease progression. Subjects with stable disease will be randomized to Arm 2 or 3.
16259605|NCT00940225|Drug|Placebo|After 12 weeks of open-label daily XL184, subjects with stable disease randomized to Arm 3 will receive capsules of placebo that are size- and color-matched to XL184 administered daily until disease progression. Subjects will be unblinded at disease progression and, if found to be receiving placebo, given the option to receive XL184.
16259606|NCT00940225|Drug|XL184|After 12 weeks of open-label daily XL184, subjects with stable disease randomized to Arm 2 will continue to receive XL184 (blinded) administered daily until disease progression.
16259607|NCT00940225|Drug|XL184|All subjects receive open-label, 100 mg XL184 (supplied at 19.7-, 50-, and 60 mg strength capsules) daily until disease progression.
16259608|NCT00940212|Drug|AZD2423|oral, single administration
16259609|NCT00940212|Drug|Placebo|oral administration and single dose
16259610|NCT00940173|Device|DIABECELL(R)|10,000 IEQ/kg injected into the peritoneal cavity via laparoscopy
16259611|NCT00940173|Device|DIABECELL(R)|15,000 IEQ/kg injected into the peritoneal cavity via laparoscopy
16259612|NCT00940173|Device|DIABECELL(R)|20,000 IEQ/kg injected into the peritoneal cavity via laparoscopy
16259613|NCT00940173|Device|DIABECELL(R)|5,000 IEQ/kg injected into the peritoneal cavity via laparoscopy
16259614|NCT00940160|Drug|QAX576|
16259615|NCT00940160|Drug|QAX576|
16259616|NCT00940160|Drug|QAX576|
16259617|NCT00940160|Drug|Placebo|
16259618|NCT00940134|Biological|PYY 3-36|0.8 pmol/kg/min x 3 hours
16259619|NCT00940134|Biological|GLP-1|1.0 pmol/kg/min x 3 hours
16259620|NCT00940134|Biological|saline infusion|saline infusion x 3 hours
16259621|NCT00940121|Drug|mirabegron|oral tablet
16259622|NCT00940121|Drug|mirabegron|IV solution
16259623|NCT00940108|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
16259624|NCT00940108|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
16259625|NCT00940095|Drug|Clazosentan 5 m/h|Continuous intravenous infusion of clazosentan (5 mg/h)
16259626|NCT00940095|Drug|Clazosentan 15 mg/h|Continuous intravenous infusion of clazosentan clazosentan (15 mg/h)
16259627|NCT00940095|Drug|Placebo|Continuous intravenous infusion of placebo-matching clazosentan
16259628|NCT00940069|Drug|pemetrexed|"'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.
~'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks."
16259629|NCT00940056|Procedure|Endoscopic ablation of AF|"The procedure is conducted in general anaesthesia. The right chest is entered with three working ports .
~After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care."
16259630|NCT00940056|Drug|Rate control|Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.
16259719|NCT00939380|Other|Respite care|Participants receive 5 hours of respite care from a child-life specialist once or twice weekly for 3 weeks.
16259631|NCT00940030|Other|mechanical bowel preparation|fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. From 16 p. m. to 20 p. m. assumption of Polyethylene Glycol Macrogol 70 mg per 1 liter of water 4 times (1L each hour). A bowel enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.
16259632|NCT00940030|Other|enema|fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. Dinner: meat broth and fasting starting from midnight. A bowel single enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.
16259633|NCT00940017|Drug|anidulafungin and voriconazole|Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
16259634|NCT00940004|Biological|autologous dendritic cell vaccination|Autologous monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase and matured with either cytokines or TLR ligands. Dendritic cells are vaccinated intradermal/intravenously 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations.
16259635|NCT00939991|Drug|Vorinostst/Bevacizumab/Temozolomide|Bevacizumab will be administered intravenously at the dose 10 mg/kg every other week. Temozolomide will be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen. Bevacizumab doses may be given by the local oncologists under the direction of the Duke investigators.
16259636|NCT00939978|Drug|rhEPO|recombinant human erythropoietin(rhEPO)
16259637|NCT00939965|Drug|isotretinoin|
16259638|NCT00939965|Genetic|DNA analysis|
16259639|NCT00939965|Genetic|polymerase chain reaction|
16259640|NCT00939965|Other|laboratory biomarker analysis|
16259641|NCT00939965|Other|pharmacological study|
16259642|NCT00939952|Drug|ertapenem|500 mg IV once
16259643|NCT00939939|Drug|sitagliptin|sitagliptin 100 mg/d for 10 weeks
16259644|NCT00939939|Drug|glimepiride|glimepiride 1 mg/d for 10 weeks
16259645|NCT00939926|Drug|Risperidone|
16259646|NCT00939913|Drug|intravenous NAC|intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)
16259647|NCT00939913|Drug|Placebo|Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.
16259648|NCT00939900|Drug|zoledronic acid (aclasta)|Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
16259649|NCT00939887|Drug|PF-04455242|Single dose of up to 30 mg PF-04455242, delivered in capsule.
16259650|NCT00939874|Drug|Raltegravir|Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
16259651|NCT00939861|Procedure|laparoscopy|colorectal resection
16259652|NCT00939861|Procedure|laparotomy|colorectal resection
16259653|NCT00939848|Drug|gemcitabine|gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
16259654|NCT00939848|Drug|cisplatin|cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
16259655|NCT00939848|Drug|Placebo|20mg od (continuous dosing) until evidence of disease progression has been confirmed
16259656|NCT00939848|Drug|cisplatin|cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
16259657|NCT00939848|Drug|cediranib|cediranib 20mg oral daily (continuous dosing)until evidence of disease progression has been confirmed
16259658|NCT00939848|Drug|gemcitabine|gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression
16259659|NCT00939835|Drug|Citalopram Hydrobromide|
16259660|NCT00939822|Drug|Simvastatin|40 mg Simvastatin/day
16259661|NCT00939822|Drug|Placebo|Matching Placebo
16259662|NCT00939809|Biological|Urokinase-Derived Peptide A6|Given SC
16259663|NCT00939809|Other|Laboratory Biomarker Analysis|Correlative studies
16259664|NCT00939796|Device|Acclarent Tympanostomy Tube Delivery System|A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
16259665|NCT00939783|Drug|Dimebon|Tablet for oral administration
16259666|NCT00939770|Drug|Crizotinib|Given PO
16259667|NCT00939770|Other|Laboratory Biomarker Analysis|Correlative studies
16259668|NCT00939770|Other|Pharmacological Study|Correlative studies
16259669|NCT00939770|Other|Questionnaire Administration|Ancillary studies
16259670|NCT00939757|Drug|mirabegron|oral tablet
16259671|NCT00939731|Drug|PF-02341066|A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules
16259672|NCT00939731|Drug|PF-02341066|A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets
16259673|NCT00939718|Dietary Supplement|Vitamin B12|Vitamin B12 injections containing methylcobalamin 1000 mcg given once every six months along with the routine antidepressant treatment.
16259674|NCT00939705|Drug|topiramate|Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
16259675|NCT00939692|Drug|Topiramate|Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
16259718|NCT00939380|Other|DVD and pamphlet|"Participants receive a Discovery to Recovery DVD and pamphlet developed by the National Marrow Donor Program (NMDP) describing psychological issues associated with hematopoietic stem cell transplantation (HSCT), the booklet Top Tips for Parent Caregivers During the BMT Process published by National Marrow Donor Program-Link describing caregiver issues during HSCT and advice on how to handle them, 2 walkie-talkies, a laptop to view the DVD."
16259720|NCT00939367|Drug|Zolpidem Tartrate Tablets 10 mg|
16259676|NCT00939679|Procedure|Roux-en-Y gastric bypass surgery|Briefly, RYGB is characterized first by creation of a small stomach pouch. The small intestine is then divided approximately 75 cm distal to the ligament of Treitz, creating a proximal intestinal limb that transports the secretions from the stomach remnant, liver, and pancreas, and a 'Roux' limb, that is attached to the new stomach pouch to drain consumed food. The distal end of the proximal limb is then reattached approximately 100 cm distal to the new stomach drainage site, creating a common channel where digestive enzymes mix with ingested food.
16259677|NCT00939679|Dietary Supplement|low calorie diet (1,000 kcal/day)|"Patients will consume a daily diet composed of:
~4 powder diet portions (Cambridge Diets, UK)
~plain yogurt (100-125g)
~skim milk (1L)
~a limited variety of vegetables
~The diet will be consumed by both groups for a 10 week period."
16259678|NCT00939666|Procedure|Wait&see or TEM with intensive follow-up|Wait&see or TEM with intensive follow-up
16259679|NCT00939653|Drug|Clofarabine|40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.
16259680|NCT00939653|Drug|Etoposide|100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.
16259681|NCT00939653|Drug|Cyclophosphamide|440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.
16259682|NCT00939653|Drug|Filgrastim|Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000 x 2 days.
16259683|NCT00939653|Drug|Cytarabine|"Given intrathecally on day 1 at the dose defined by age below:
~30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients >3 years of age"
16259684|NCT00939640|Behavioral|DASH/sodium-restricted diet (SRD)|Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
16259685|NCT00939627|Biological|cetuximab|Given IV
16259686|NCT00939627|Other|placebo|Given orally
16259687|NCT00939627|Drug|sorafenib tosylate|Given orally
16259688|NCT00939627|Other|laboratory biomarker analysis|Correlative studies
16259689|NCT00939627|Procedure|quality-of-life assessment|Ancillary studies
16259690|NCT00939614|Drug|Lamotrigine|
16259691|NCT00939601|Behavioral|Motivational Enhancement Therapy|
16259692|NCT00939601|Behavioral|Educational Counseling|
16259693|NCT00939588|Drug|Aliskiren/ Valsartan|
16259694|NCT00939588|Drug|Telmisartan/ Ramipril|
16259695|NCT00939562|Drug|doxycycline monohydrate tablet|Tablet, 100 mg, Single dose
16259696|NCT00939562|Drug|doxycycline carragenate tablet|Tablet, 100 mg, Single dose
16259697|NCT00939549|Drug|Cyclophosphamide/Glatiramer acetate|Cyclophosphamide 50 mg/kg IV each day for four consecutive days. Glatiramer acetate 20 mg SC daily for 1 year.
16259698|NCT00939536|Drug|Zolpidem Tartrate Tablets 10 mg|
16259699|NCT00939523|Drug|Lapatinib|All participants will be asked to take Lapatinib daily for six months during the research study.
16259700|NCT00939510|Biological|sargramostim|All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF.
16259701|NCT00939510|Drug|lenalidomide|Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose.
16259702|NCT00939510|Other|laboratory biomarker analysis|Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.
16259703|NCT00939497|Drug|Risperidone|
16259704|NCT00939484|Other|Pharmacological Study|Correlative studies
16259705|NCT00939484|Drug|Vismodegib|Given PO
16259706|NCT00939471|Device|Relieva™ Balloon Sinuplasty™ System|Balloon dilation will be performed using endoscopic equipment with video documentation capability.
16259707|NCT00939458|Drug|Lamotrigine|
16259708|NCT00939445|Procedure|Online HDF|Online HDF
16259709|NCT00939445|Procedure|Short Daily Hemodialysis|Short Daily Hemodialysis
16259710|NCT00939419|Other|Health workers TB care group|Patients received daily tuberculosis care in public health facilities by trained health worker during the first 8 weeks followed by self-treatment for the remaining 6 months. Patients were expected to visit public health facility every month for follow up. Supervisory support was given to TB focal persons by the respective district TB coordinators on a monthly basis. Anti-TB drugs were delivered to health institutions on a quarterly basis by district TB coordinators during supervision
16259711|NCT00939419|Other|Community health workers TB care group|Patients had daily TB care including observation of treatment by the CHWs in their villages for the second month. Thereafter, treatment was self-administered with a monthly follow up visit to a CHW home for the remaining 6 months. Technical support and anti-TB drugs were given to CHWs by the respective public health facility TB health worker every fortnight.
16259712|NCT00939419|Other|Self-administered treatment group|Patients took their medication at home for seven months after one month of daily care in public health facilities by TB health workers. They were taught by the TB health worker to collect their anti-TB drugs fortnightly and report missed daily doses. Follow up assessment and continued support was made by TB health worker on a monthly basis in their nearby health facility.
16259713|NCT00939406|Device|Hyalospine|Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
16259714|NCT00939393|Device|FESS instruments with or without balloon treatment|Intervention with metal instruments with or without balloon treatment
16259715|NCT00939393|Device|Balloon Sinuplasty|Balloon dilatation of sinuses
16259716|NCT00939380|Behavioral|Behavioral intervention sessions|Participants undergo five 60-minute behavioral intervention sessions once or twice weekly for 3 weeks to learn how to engage in effective social and cognitive processing to deal with fears and worries about the transplant and transplant-related concerns.
16259717|NCT00939380|Other|CD-ROM|Participants receive a laptop computer and a CD-ROM after the first session of behavioral intervention.
16259722|NCT00939341|Drug|Symbicort (Budesonide/Formoterol)|Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms
16259723|NCT00939328|Biological|rituximab|
16259724|NCT00939328|Drug|bendamustine hydrochloride|
16259725|NCT00939289|Device|Continuous Glucose Monitoring|Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator)
16259726|NCT00939276|Drug|Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)|One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
16259727|NCT00939276|Drug|Nepafenac ophthalmic suspension vehicle|One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
16259728|NCT00939263|Other|assessment of disease activity using the EEsAI|disease activity index
16259729|NCT00939250|Behavioral|Diabetes and depression intervention|Disease self management for diabetes and depression
16259730|NCT00939250|Behavioral|Diabetes intervention|Disease self management for diabetes
16259731|NCT00939237|Drug|Ateronon|7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily
16259732|NCT00939237|Drug|Placebo|
16259733|NCT00939224|Device|Model 7600 Regional Oximeter System|Non-invasive regional oxygen saturation measurements
16259734|NCT00939211|Drug|AZD9164|Solution for inhalation through nebulization, single dose
16259735|NCT00939211|Drug|Tiotropium|Dry powder for inhalation, single dose
16259736|NCT00939211|Drug|Placebo|Placebo
16259737|NCT00939198|Biological|Na-ASP-2 Skin Test Reagent|Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
16259738|NCT00939185|Drug|Azithromycin|Zithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
16259739|NCT00939172|Drug|TTP607|3.3 mg/m^2 given by central venous catheter over 1-4 hours, each day for 5 days in a row, for a 15 day cycle.
16259740|NCT00939159|Drug|LBH589|20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
16259741|NCT00939146|Other|Outlook Attention Control|Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.
16259742|NCT00939146|Other|Outlook Intervention|The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.
16259743|NCT00939133|Drug|tretinoin microsphere 0.04% gel|Applied daily to entire face for six months
16259744|NCT00939133|Drug|vehicle gel|Placebo
16259745|NCT00939120|Drug|Tolterodine ER 4mg|1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily
16259746|NCT00939120|Drug|Placebo|1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily
16259747|NCT00939120|Drug|Pre-randomization Dutasteride|All participants were on Dutasteride 0.5mg orally once daily prior to randomization.
16259748|NCT00939107|Procedure|spinal manipulation|Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
16259749|NCT00939107|Procedure|McKenzie exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
16259750|NCT00939094|Drug|AZD2066|Capsule, once daily
16259751|NCT00939094|Drug|Placebo|Capsule, once daily
16259752|NCT00939081|Behavioral|Adaptive step recommendation|Participants in this group receive 3 education sessions: at baseline, at 3 months and at 6 months. The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day. The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
16259753|NCT00939081|Behavioral|10,000 step/day recommendation|Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
16259754|NCT00939068|Drug|Telbivudine|Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
16259755|NCT00939068|Biological|engineered HB vaccine|All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.
16259756|NCT00939055|Device|StomaphyX|Transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
16259757|NCT00939055|Procedure|Sham procedure|False procedure
16259758|NCT00939042|Procedure|Percutaneous Coronary Intervention|common Percutaneous Coronary Intervention
16259759|NCT00939042|Procedure|BMNC therapy|Injection of BMNC after common PCI
16259760|NCT00939029|Drug|nicotine replacement therapy (nicotine patches)|2- 21 mg patches per day for 8 weeks
16259761|NCT00939029|Drug|placebo NRT|2 placebo patches (containing no active ingredient)per day for 8 weeks
16259762|NCT00939016|Other|Lunch meal with 24 hour dietary recall|Each participant will come into the laboratory for a buffet-style lunch meal, where they are instructed to sample each of the foods served. On the next day, a 24 hour dietary recall is performed to test the participants ability to accurately report amounts and types of food consumed. Measures of dietary restraint and social desirability are taken prior to the laboratory meal via phone interview.
16259763|NCT00939003|Biological|Adalimumab|40 mg every other week up to Week 12
16259764|NCT00939003|Biological|Placebo|Placebo every other week up to Week 12
16259765|NCT00939003|Biological|Open-label Adalimumab|40 mg every other week, Week 12 through Week 156
16259766|NCT00938990|Drug|Etomidate|
16259767|NCT00938990|Drug|Midazolam|
16259769|NCT00938977|Device|Bilevel Support Ventilation (Non-Invasive Ventilation)|before/after effect of Bilevel support ventilation
16259770|NCT00938964|Drug|Lidocaine|Lidocaine versus placebo infusion for 48 hours
16259771|NCT00938964|Drug|Placebo|Lidocaine versus placebo infusion for 48 hours
16259772|NCT00938951|Other|Systane® Ultra|Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%
16259773|NCT00938938|Other|Press Guide|The press guide is a 1-page summary of the study findings, written by the investigators.
16259774|NCT00938925|Procedure|Nail lacquer plus aggressive debridement|Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.
16259775|NCT00938925|Procedure|Nail lacquer alone|Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
16259776|NCT00938912|Drug|Lacosamide|Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)
16259777|NCT00938912|Drug|Lacosamide|"Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid).
~The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day."
16259778|NCT00938899|Drug|TMC435350; Placebo|
16259779|NCT00938886|Drug|Naltrexone|Daily 50 mg naltrexone
16259780|NCT00938886|Drug|Placebo|Matched naltrexone placebo
16259781|NCT00938873|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|Mindfulness based cognitive therapy (MBCT) is a group psycho-educational treatment designed to reduce the risk of recurrent depression by integrating mindfulness based meditation practices with cognitive therapy techniques. MBCT comprises eight weekly two-hour group sessions with an additional one hour daily 6 days a week for meditative homework practice.
16259782|NCT00938860|Drug|cyclosporin (Neoral)|Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
16259783|NCT00938860|Drug|tacrolimus (Prograf)|Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.
16259784|NCT00938847|Device|PCI|Stent implantation after acute myocardial infarction
16259785|NCT00938834|Other|CFQ Qigong|CFQ Qigong training session training will consist of three half days of training in the technique. Following the training sessions, participants will return to the study site on a weekly basis for the first 8 weeks.
16259786|NCT00938821|Procedure|Caudal block|Chart review of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B)from October 2008 to October 2009.
16259787|NCT00938808|Dietary Supplement|day formula diet|The Cambridge Programme. Formula diet
16259788|NCT00938795|Other|Uncertainty Management Intervention|Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
16259789|NCT00938795|Other|Comparison Conditions for Liver Transplant|Six 30-minute telephone calls that provide structured education about liver disease.
16259790|NCT00938782|Device|Sedline|
16259791|NCT00938769|Other|Self-Efficacy Training for Caregivers|"The Enhanced Caregiver Training intervention will be delivered to informal caregivers of cancer patients before hospital discharge who are randomly selected to receive this intervention. Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress.
~2-hour in-person instruction of home care issues for caregivers of patients with cancer."
16259792|NCT00938769|Other|Comparison Conditions for Caregivers|"Subjects randomly selected to participate in the attention control training will receive an informational session about cancer and resources for caregiving.
~2-hour counseling session for cancer caregivers to locate community support resources"
16259793|NCT00938756|Other|diagnostic laboratory biomarker analysis|
16259794|NCT00938756|Other|immunoenzyme technique|
16259795|NCT00938756|Procedure|magnetic resonance imaging|
16259796|NCT00938743|Drug|Atomoxetine|40-80 mg atomoxetine once daily, including titration 10 weeks
16259797|NCT00938730|Drug|YM150|oral
16259798|NCT00938730|Drug|Warfarin|oral
16259799|NCT00938717|Drug|Linaclotide or Matching Placebo|Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
16259800|NCT00938704|Drug|carboxymethylcellulose 0.5% +glycerin 0.9%|To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
16259801|NCT00938704|Drug|sodium hyaluronate 0.18%|To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
16259802|NCT00938691|Procedure|Intradermal Suture|
16259803|NCT00938691|Procedure|Intradermal Suture|
16259804|NCT00938678|Drug|Pegfilgrastim Hospira|Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
16259805|NCT00938678|Drug|Neulasta (Amgen)|Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
16259806|NCT00938665|Device|COGNISION™ System|30 minute ERP test and 3 minute resting EEG data collected from cognitively healthy and AD to validate ERP and qEEG as useful cognitive biomarkers for AD.
16259807|NCT00938652|Drug|gemcitabine/carboplatin|"Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)
~Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)"
16259808|NCT00938652|Drug|Iniparib|"Body weight adjusted dose
~intravenous infusion (60 ± 10 minutes)"
16259809|NCT00938639|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
16259810|NCT00938639|Biological|CSL425|CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
16259811|NCT00938626|Biological|anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells|After completion of induction or salvage chemotherapy, patients receive immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks.
16259865|NCT00938314|Drug|human chorionic gonadotropin (hCG), then epoetin alfa (EPO)|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
16259812|NCT00938626|Procedure|autologous hematopoietic stem cell transplantation|At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
16259813|NCT00938626|Procedure|peripheral blood stem cell transplantation|At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation.
16259814|NCT00938613|Drug|Budesonide|nasal spray, one spray per nostril at time 0
16259815|NCT00938613|Drug|Placebo|nasal spray, one spray per nostril at time 0
16259816|NCT00938613|Drug|Budesonide|nasal spray, one spray per nostril at time 0
16259817|NCT00938600|Dietary Supplement|Vitamin D3|Vitamin D3 oral liquid 70,000 IU once
16259818|NCT00938600|Dietary Supplement|Vitamin D3|Vitamin D3 oral liquid 70,000 IU as loading dose, then 35,000 IU weekly thereafter for 10 weeks (non-pregnant) or until delivery (pregnant)
16259819|NCT00938600|Dietary Supplement|Vitamin D3|Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.
16259820|NCT00938587|Drug|PF-04171327 10 mg|PF-04171327 10 mg tablet every day for 14 days
16259821|NCT00938587|Other|Prednisone Placebo|Placebo for Prednisone 5 mg tablet every day for 14 days
16259822|NCT00938587|Drug|PF-04171327 25 mg|PF-04171327 25 mg tablet every day for 14 days
16259823|NCT00938587|Other|Prednisone Placebo|Placebo for Prednisone 5 mg tablet every day for 14 days
16259824|NCT00938587|Drug|Prednisone 5 mg|Prednisone 5 mg tablet every day for 14 days
16259825|NCT00938587|Other|Placebo for PF-04171327|Placebo for PF-04171327 every day for 14 days
16259826|NCT00938587|Other|Placebo|Placebo tablet every day for 14 days
16259827|NCT00938587|Other|Placebo for PF-04171327|Placebo tablet every day for 14 days
16259828|NCT00938574|Drug|Atu027|
16259829|NCT00938561|Drug|Inulin|
16259830|NCT00938548|Drug|Pregabalin|Pregabalin 75 mg orally
16259831|NCT00938548|Drug|Vitamin Complex (placebo)|Vitamin Complex orally
16259832|NCT00938535|Behavioral|Obesity Prevention|This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.
16259833|NCT00938522|Drug|Cilostazol|Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
16259834|NCT00938522|Drug|Placebo|Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
16259835|NCT00938509|Drug|ibuprofen suppositories|5-10 mg/kg/day-suppositories
16259836|NCT00938483|Other|Nutramigen Lipil (Infant formula)|
16259837|NCT00938470|Drug|capecitabine|Given PO
16259838|NCT00938470|Drug|docetaxel|Given IV
16259839|NCT00938470|Drug|fluorouracil|Given IV
16259840|NCT00938470|Drug|oxaliplatin|Given IV
16259841|NCT00938470|Radiation|radiation therapy|Undergo radiation therapy
16259842|NCT00938470|Procedure|therapeutic conventional surgery|Undergo surgery
16259843|NCT00938457|Radiation|stereotactic radiation therapy|Patients undergo stereotactic body radiation therapy
16259844|NCT00938457|Procedure|implanted fiducial-based imaging|radiation therapy treatment planning
16259845|NCT00938457|Procedure|cone-beam computed tomography|radiation therapy treatment planning
16259846|NCT00938431|Drug|Lacosamide|Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
16259847|NCT00938418|Radiation|Dose escalated, accelerated, hypofractionated radiotherapy|Intensity modulated radiotherapy with concurrent chemotherapy
16259848|NCT00938405|Drug|Colesevelam HCl|3.75 gms/day of colesevelam HCl in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.
16259849|NCT00938405|Drug|Placebo|Placebo: 3.75 gms/day in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.
16259850|NCT00938392|Biological|GSK investigational FluNG vaccine GSK2186877A, aged lot|Single dose, intramuscular injection
16259851|NCT00938392|Biological|GSK investigational FluNG vaccine GSK2186877A, fresh lot|Single dose, intramuscular injection
16259852|NCT00938379|Drug|20% deet insect repellent|skin-applied repellent lotion
16259853|NCT00938379|Drug|placebo control|Identical base formulation of lotion but without any deet active
16259854|NCT00938366|Drug|Cladribine|Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days.
16259855|NCT00938366|Drug|Pantoprazole|Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period.
16259856|NCT00938353|Drug|beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml|Single dose 1600 mcg/4 ml
16259857|NCT00938353|Drug|Placebo solution for nebulisation 2 ml|single dose: 4 ml
16259858|NCT00938340|Dietary Supplement|"Walnut meat"|Separated, ground walnut de-fatted nut meat incorporated into inert food carrier
16259859|NCT00938340|Dietary Supplement|Walnut Oil|Walnut oil extracted from nut meat and incorporated into inert food carrier
16259860|NCT00938340|Dietary Supplement|Walnut Skins|Separated, ground walnut skins incorporated into inert food carrier
16259861|NCT00938340|Dietary Supplement|Whole walnut|85g whole walnuts, ground, incorporated into inert food carrier
16259862|NCT00938327|Biological|Rotarix™|Two doses of oral vaccine.
16259863|NCT00938314|Drug|human chorionic gonadotropin (hCG), then epoetin alfa (EPO)|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
16259864|NCT00938314|Drug|human chorionic gonadotropin (hCG), then epoetin alfa (EPO)|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
16259866|NCT00938314|Drug|Saline Placebo|Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation
16259867|NCT00938301|Drug|PF-04455242|Powder-in Capsule (EP-PIC), will be used to administer doses from 0.5 mg up to and including 56 mg of a single rising dose over 3 treatment periods receiving two doses of PF-04455242 and one dose of placebo. A one-week (minimum) washout will separate each treatment period.
16259868|NCT00938301|Drug|Placebo|PIC matching in appearance to PF-04455242 will be used to administer placebo.
16259869|NCT00938288|Drug|KW-3357|50IU/mL, IV single dose
16259870|NCT00938275|Drug|0.5g SRT2104|"SRT2104 will be supplied in two forms: as 0.5g powder which will be prepared by the pharmacist/designee into a liquid suspension and as two hard gelatin capsules, each containing 0.25g SRT2104. The dosing vehicle for the liquid suspension is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104.
~Each formulation of test material will be administered orally, in a single dose to the subjects in the fasted state and following consumption of a standard meal. Neither the investigator nor the subjects enrolled will be blinded to treatment assignment."
16259871|NCT00938262|Drug|Fimasartan, Ketoconazole, Rifampicin|"Fimasartan (1 day)
~Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day)
~Rifampicin (9 days) Rifampicin + Fimasartan (1 day)"
16259872|NCT00938249|Dietary Supplement|Monascus Garlic Fermented Extract|
16259873|NCT00938249|Dietary Supplement|Placebo|
16259874|NCT00938236|Drug|Cyclosporine Inhalation Solution (CIS)|Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration
16259875|NCT00938223|Biological|4-peptide and 12-peptide melanoma vaccines|"Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.
~Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.
~Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.
~All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN)."
16259876|NCT00938210|Procedure|Laparoscopic colonic surgery|Laparoscopic removal of colonic cancer
16259877|NCT00938197|Drug|Fimasartan|Fimasartan (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d)
16259878|NCT00938197|Drug|Amlodipine|Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)
16259879|NCT00938184|Drug|Paroxetine 12.5 milligrams tablet|Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
16259880|NCT00938184|Drug|Paroxetine 25 milligrams tablet|Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
16259881|NCT00938184|Drug|Paroxetine 50 milligrams tablet|Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
16259882|NCT00938171|Procedure|Local anesthesia|All patients will be then given adequate sedation with propofol and local anesthetic given by dermal infiltration in incision site and regional breast and axillary areas. The local anesthetic of choice will be 2 % lidocaine (Xylocaine) and 0.5% Bupivacaine (Marcaine) mixed with 7 % sodium bicarbonate and epinephrine (Bosmine)
16259883|NCT00938171|Procedure|General anesthesia|The method of general anesthesia for the GA group will be induced with fentanyl (1-2 μg/kg) and propofol (2.5 mg/kg). After placement of a laryngeal mask or endotracheal tube airway, anesthesia will be maintained with sevoflurane (end-tidal concentrations 1%-3%) in a 50% oxygen/nitrous oxide mixture.
16259884|NCT00938158|Biological|albiglutide|single dose of subcutaneously injected albiglutide
16259885|NCT00938145|Procedure|Specimen Ultra-High field MRI|Immediately following removal of the bladder and lymph nodes, the specimens will be transported to the ultra-high-field MRI scanner for high resolution imaging.
16259886|NCT00938145|Drug|chemotherapy|The majority of patients will be candidates to receive neoadjuvant chemotherapy prior to radical cystectomy as part of standard clinical care. Patients will most often receive cisplatin based therapy for a period of three months (four 21 day cycles).
16259887|NCT00938145|Procedure|Cystectomy and Lymphadenectomy|The patient will undergo radical cystectomy and pelvic lymph node dissection with no deviation from standard surgical care. A urinary tract reconstruction will follow as either a continent or incontinent form of diversion.
16259888|NCT00938132|Drug|fimasartan, warfarin|Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)
16259889|NCT00938106|Radiation|optimised magnetic resonance image-guided intra-uterine brachytherapy|Brachytherapy treatment will be planned based on the MRI test and will be individualized for each study participant,based on participant's cancer and body inside.Brachytherapy will be as an inpatient over 2-3 days. All other care will follow standard procedures.
16259890|NCT00938093|Behavioral|Cognitive behavioral therapy|Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.
16259891|NCT00938093|Behavioral|Enhanced usual care|Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.
16259892|NCT00938080|Biological|AG013|Mouth rinse once a day for 14 days
16259893|NCT00938080|Biological|AG013|Mouth rinse three times a day for 14 days
16259894|NCT00938080|Biological|AG013|Mouth rinse six times a day for 14 days
16259895|NCT00938080|Other|Placebo|Mouth rinse once a day for 14 days
16259896|NCT00938080|Other|Placebo|Mouth rinse three times a day for 14 days
16259897|NCT00938080|Other|Placebo|Mouth rinse six times a day for 14 days
16259946|NCT00937677|Drug|Tysabri|"Infusion of TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour at month 0 and 12 and 24 months. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP.
~Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI®.
~TYSABRI® concentrate is supplied as 300 mg natalizumab in a sterile, single-use vial free of preservatives. Each package contains a single-use vial."
16259898|NCT00938067|Behavioral|Staying Connected|The overarching goal of the Staying Connected intervention is to establish a compassionate and culturally sensitive treatment trajectory that diminishes posttraumatic suffering by reducing symptomatic distress, improving functional recovery, and reducing the risk of injury recurrence. This trajectory begins with surgical treatment and extends through outpatient care and community rehabilitation. The collaborative care intervention fundamentally restructures the delivery of mental health care within trauma care systems by bringing together providers currently working independently to form an interdisciplinary mental health team. Team members work together and in a liaison capacity with other trauma center providers and community practitioners in order to bridge care across service delivery sectors.
16259899|NCT00938041|Biological|Tositumomab and Iodine I 131 Tositumomab|Tositumomab and Iodine I 131 Tositumomab
16259900|NCT00938015|Other|Questionnaire|This is a non-interventional study
16259901|NCT00938015|Other|Questionnaire|This is a non-interventional study
16259902|NCT00938002|Diagnostic Test|Acceler8 Pheno|
16259903|NCT00937989|Other|educational intervention|Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
16259904|NCT00937989|Other|informational intervention|Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
16259905|NCT00937989|Other|medical chart review|Baseline, 3, 6 and 9 months after starting the study
16259906|NCT00937989|Other|questionnaire administration|Baseline, 3, 6 and 9 months after starting the study
16259907|NCT00937989|Other|study of socioeconomic and demographic variables|Baseline, 3, 6 and 9 months after starting the study
16259908|NCT00937989|Procedure|quality-of-life assessment|Baseline, 3, 6 and 9 months after starting the study
16259909|NCT00937976|Procedure|Periodontal Scaling and Root Planing|Participants will take antibiotics prior to dental treatment. Periodontal treatment or a deep cleaning (with local anesthesia or numbing) will be performed to remove plaque and tartar around the teeth and gums. A small amount of antibiotics (minocycline) will be placed around the gums to help fight bacteria and inflammation.
16259910|NCT00937963|Dietary Supplement|Palm DAG Oil|Use of Palm DAG Oil to replace palm oil traditionally used in foods
16259911|NCT00937950|Other|Gynaecological follow-up|Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
16259912|NCT00937937|Drug|Dinaciclib|Given IV
16259913|NCT00937924|Drug|Saline|Saline solution injections
16259914|NCT00937924|Drug|Diphenhydramine|Diphenhydramine injections
16259915|NCT00937924|Drug|Promethazine|Promethazine
16259916|NCT00937911|Drug|YM150|oral
16259917|NCT00937898|Dietary Supplement|BOLD+ Diet|Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors
16259918|NCT00937898|Dietary Supplement|BOLD diet|Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease
16259919|NCT00937885|Behavioral|Implementation of reminiscence|
16259920|NCT00937872|Drug|250 mg SRT2104 Suspension|Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation.
16259921|NCT00937872|Drug|Carbon-14 radio-labeled SRT2104|Single 10 mL IV dose containing 100 microgram (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104, administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose is administered.
16259922|NCT00937859|Drug|SER120|SER120
16259923|NCT00937859|Drug|Placebo|Placebo
16259924|NCT00937846|Drug|GSK1034702|Single oral 5 mg dose in liquid formulation
16259925|NCT00937833|Procedure|Prostatectomy|
16259926|NCT00937833|Device|Surgisis Male Sling|
16259927|NCT00937820|Drug|YM150|oral
16259928|NCT00937807|Drug|xenon|Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
16259929|NCT00937807|Drug|sévoflurane|Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
16259930|NCT00937794|Behavioral|Neurobehavioral testing|If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to assess his neurodevelopmental status using a standardized battery of neurobehavioral testing.
16259931|NCT00937794|Other|Visual and auditory assessments|If the patient is found to be eligible after completion of a telephone interview, he will undergo further testing to evaluate his visual and auditory function.
16259932|NCT00937781|Genetic|RNA analysis|
16259933|NCT00937781|Genetic|gene expression analysis|
16259934|NCT00937781|Genetic|microarray analysis|
16259935|NCT00937781|Genetic|polymerase chain reaction|
16259936|NCT00937781|Other|immunohistochemistry staining method|
16259937|NCT00937781|Other|laboratory biomarker analysis|
16259938|NCT00937768|Drug|Goserelin Acetate|Given SC
16259939|NCT00937768|Other|Laboratory Biomarker Analysis|Correlative studies
16259940|NCT00937768|Drug|Leuprolide Acetate|Given IM
16259941|NCT00937768|Other|Quality-of-Life Assessment|Ancillary studies
16259942|NCT00937742|Dietary Supplement|Tomato products|Specified amounts of tomato products (i.e. tomato juice, ketchup, salsa, tomato soup, spaghetti sauce) to be consumed daily during a 6 week intervention phase.
16259943|NCT00937703|Device|placebo|paper support for glycaemia face to face visit at T4mounths
16259944|NCT00937703|Device|IVS|"patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation.
~Face to face visit at T4mounths plus telephone visits each 2 weeks."
16259945|NCT00937703|Device|PDAphone|Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
16259947|NCT00937664|Drug|AZD7762|solution, intravenous, weekly
16259948|NCT00937664|Drug|gemcitabine|intravenous, weekly
16259949|NCT00937651|Drug|Placebo|Placebo
16259950|NCT00937651|Drug|Fimasartan (BR-A-657•K) 20 mg|Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
16259951|NCT00937651|Drug|Fimasartan (BR-A-657•K) 60 mg|Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
16259952|NCT00937651|Drug|Fimasartan (BR-A-657•K) 180 mg|Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
16259953|NCT00937638|Dietary Supplement|BOLD Diet|Low-fat, high fruit and vegetable diet that includes lean beef (5oz/day)
16259954|NCT00937638|Dietary Supplement|BOLD-X Diet|Low-fat, moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet. Also high in fruits and vegetables
16259955|NCT00937638|Dietary Supplement|Modified DASH Diet|Low-fat, high fruit and vegetable diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors and metabolic syndrome
16259956|NCT00937625|Biological|cyclophosphamide, fludarabine, T-cells, Interleukin-2|Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.
16259957|NCT00937612|Radiation|Radiotherapy|postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin
16259958|NCT00937599|Dietary Supplement|Brazil Nut|During 16 weeks the adolescents consumed 3-5 nuts/day
16259959|NCT00937560|Drug|Bevacizumab|Bevacizumab was supplied as a sterile solution for infusion.
16259960|NCT00937560|Drug|Paclitaxel|Paclitaxel was supplied locally in commercial batches.
16259961|NCT00937560|Drug|Carboplatin|Carboplatin was supplied locally in commercial batches.
16259962|NCT00937534|Drug|Fimasartan|Fimasartan 240mg/day
16259963|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation I
16259964|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation II
16259965|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation III
16259966|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation IV
16259967|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation V
16259968|NCT00937521|Biological|Meningococcal B vaccine|Vaccine candidate formulation VI
16259969|NCT00937521|Biological|Control|Control
16259970|NCT00937521|Biological|Meningococcal B vaccine with antipyretic|Vaccine candidate formulation I with antipyretic
16259971|NCT00937508|Behavioral|Smoking counseling|Preoperative and postoperative counseling sessions provided by a trained smoking counselor along with placebo.
16259972|NCT00937508|Drug|varenicline|varenicline (an approved medication for smoking cessation)
16259973|NCT00937508|Drug|placebo|sugar pill without any active medication
16259974|NCT00937495|Drug|vorinostat|400 mg given PO
16259975|NCT00937495|Drug|bortezomib|1.3 mg/m^2 given IV
16259976|NCT00937482|Drug|cediranib maleate|Given orally
16259977|NCT00937482|Radiation|whole-brain radiation therapy|Undergo whole-brain radiotherapy
16259978|NCT00937469|Behavioral|Social skills training, parental tr. and standard tr.|Social skills training will consist of 8 weeks of group treatment with weekly sessions of one and a half hours and includes role play, exercises and games as well as home work which will include the parents. At the same time the parents are participating in parental training groups,that will focus on supporting the children's social training. Both the children and the parental groups are lead by two group therapists. The intervention will be additional to the received standard treatment.
16259979|NCT00937469|Other|Standard treatment|The standard treatment consists of medical treatment, briefing, consulting and supporting conversations with a focus on securing compliance to the treatments´ and on aiding children and their families with the difficulties arising with the children's illness. Furthermore the parents participate in parental groups three times during the 8 weeks in which the experiment takes place. This group lasts 2 hours and is managed by two nurses who are attached to the ADHD- treatment group.
16259980|NCT00937456|Procedure|Laparoscopically-assisted esophagectomy|To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy
16259981|NCT00937443|Other|Physical Fitness|Does intensity of aerobic walking exercise modify cardiac reparative factors
16259982|NCT00937443|Biological|Walking Exercise Group|Walking Group will increase intensity, duration, and steps of walking per week.
16259983|NCT00937430|Other|Bowel preparation (Fleets enema)|Use of Bowel preparation (Fleets enema)
16259984|NCT00937417|Drug|docetaxel|
16259985|NCT00937417|Drug|vandetanib|
16259986|NCT00937417|Genetic|proteomic profiling|
16259987|NCT00937417|Other|laboratory biomarker analysis|
16259988|NCT00937417|Other|pharmacological study|
16259989|NCT00937404|Biological|Poliorix|All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.
16259990|NCT00937391|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-6661)|For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
16259991|NCT00937378|Drug|SER120|Nasal Spray, once a day
16259992|NCT00937378|Drug|Placebo|Nasal Spray
16259993|NCT00937365|Behavioral|Exercise|Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
16259994|NCT00937365|Procedure|Spinal Manipulation|Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
16259995|NCT00937365|Procedure|Neuroemotional Technique (NET)|Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
16259996|NCT00937352|Drug|Bapineuzumab|"0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
~1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years."
16259997|NCT00937339|Device|Whole body vibration therapy|Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session.
16259998|NCT00937339|Device|Exercise on the vibration platform with the device turned off|Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied.
16259999|NCT00937326|Drug|SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.
16260000|NCT00937326|Drug|Placebo|Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
16260001|NCT00937313|Other|Champagne wine intervention|Placebo-controlled randomised cross-over human trial
16260002|NCT00937300|Biological|cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2|Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks.
16260003|NCT00937287|Other|There is no intervention in this study.|No intervention is provided in this study as it is exploratory.
16260004|NCT00937274|Other|T4 phage cocktail test|T4 phages 106 PFU/ ml up to 5 days
16260005|NCT00937274|Other|Commercial T4 phage cocktail|Treatment as recommended by the manufacturer (Microgen phages)
16260006|NCT00937274|Other|standard oral rehydration solution (ORS)|Standard hospital treatment with ORS
16260007|NCT00937261|Drug|Risperidone|2mg - 8mg per day, for the duration of participation in the study
16260008|NCT00937261|Drug|Paliperidone|6mg - 12mg per day, for the duration of participation in the study
16260009|NCT00937248|Device|prone pillow and simple ankle fixation device|Patients will lie face down (prone) on a soft cushion made of foam under their face and upper chest. Additionally, there is a foam support placed at the ankles.
16260010|NCT00937248|Device|Customized Vacuum Immobilization Device (CVID)|This device is a bean bag like cushion that is placed from the abdomen to the thighs. When a patient is comfortably lying on this device, air within the bag is suctioned out resulting in an impression or cast of a patient.
16260011|NCT00937235|Drug|Varenicline|1 mg tablets, orally, twice daily x 12 weeks
16260012|NCT00937235|Behavioral|Medication Management Counseling|15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
16260013|NCT00937235|Behavioral|Prolonged Exposure|75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
16260014|NCT00937222|Dietary Supplement|Peanuts and peanut butter|Peanuts and peanut butter
16260015|NCT00937196|Drug|Placebo globuli|placebo globuli administered together with verbal suggestions of a hypotensive drug effect
16260016|NCT00937196|Drug|Histaminum hydrochloricum globuli|
16260017|NCT00937183|Biological|autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine|
16260018|NCT00937183|Biological|autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine|
16260019|NCT00937183|Biological|autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine|
16260020|NCT00937170|Device|Zimmer LPS flex Gender Specific Implant (Total knee replacement)|Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
16260021|NCT00937170|Device|Zimmer High Flex LPS Implant (Total knee replacement)|Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
16260022|NCT00937170|Device|Stryker Triathlon Implant (Total knee replacement)|Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company
16260023|NCT00937157|Drug|Copaxone|12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
16260024|NCT00937144|Drug|Viagra (Sildenafil)|Viagra treatment to patients with sickle cell anemia.
16260025|NCT00937144|Drug|placebo|
16260026|NCT00937131|Drug|Rituximab|Concentrate for solution for infusion, Intravenous use, 375mg/m2, Maximum 8 weekly infusions
16260027|NCT00937105|Device|lotrafilcon A contact lenses|FDA approved soft contact lenses
16260028|NCT00937105|Device|Renu Multiplus|
16260029|NCT00937105|Device|Clear Care|
16260030|NCT00937092|Drug|Furosemide|High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
16260031|NCT00937092|Drug|low-dose dopamine + low-dose furosemide|low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)
16260032|NCT00937079|Other|111In-exendin-4 imaging|90-100 megabecquerel (MBq) (30 microgram or less) 111In-exendin-4 IV once
16260033|NCT00937053|Other|Transfusion level 120 g/dL|Patients whose hemoglobin falls below 120 g/dL will be transfused with red cells within 24 hours.
16260034|NCT00937053|Other|Transfusion level 70 g/dL|Patients whose hemoglobin falls below 70 g/dL will be transfused with red cells within 24 hours
16260035|NCT00937053|Other|Platelet transfusion|Patients whose platelets fall below 10 x 10*9 will be transfused with platelets
16260036|NCT00937040|Drug|OROS MPH|Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks
16260037|NCT00937040|Drug|Placebo|Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks
16260038|NCT00937040|Drug|OROS MPH Tablets|Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks
16260039|NCT00937040|Drug|Placebo Tablets|Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
16260040|NCT00937027|Drug|Aminopterin|oral tablets, 1.0 mg dose, once weekly, two weeks
16260041|NCT00937014|Other|standard infant formula|Standard infant formula given during the first 9 months of life, as per standard requirement
16260206|NCT00935805|Drug|Metformin|850 mg TID
16260042|NCT00937014|Other|Test formula|Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
16260043|NCT00937001|Procedure|Biopsy/Ultrasound|obtain muscle biopsies at approximately 14 days of ICU, muscle ultrasound at 3-4 timepoints
16260044|NCT00936988|Drug|cinacalcet|Subjects began open-label treatment with 30 mg cinacalcet twice daily (BID) at the start of the current study. The study consisted of 2 phases planned to total approximately 4¾ years: a 12-week dosetitration phase (visits at weeks 2, 3, 4, 6, 9, and 12) during which 1 possible dose increase of cinacalcet from 30 mg BID to 50 mg BID could occur at week 6, and a maintenance phase (week 12 to 234; visits approximately every 4 weeks until week 24 and approximately every 14 weeks thereafter) during which doses also could be titrated. After July 2004, because of a change in dose strengths, the daily doses used in the study were 30 and 60 mg BID with the option to reduce to 30 mg once daily (QD), if necessary. Ongoing subjects receiving 50 mg BID were switched at that time to 60 mg BID.
16260045|NCT00936975|Radiation|Fluorine F 18 Sodium Fluoride|Undergo fluorine F 18 sodium fluoride PET scan
16260046|NCT00936962|Biological|NeisVac C vaccine (12mth)|NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
16260047|NCT00936949|Procedure|surgical approach|Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture.
16260048|NCT00936949|Procedure|modified lateral approach|The operative technique described modified lateral approach as described by Mulliken et al.
16260049|NCT00936936|Drug|Gemcitabine|1800 mg/m^2 IV over 3 hours on Days -5 to Day -2.
16260050|NCT00936936|Drug|Docetaxel|Docetaxel 300 mg/m^2 IV over 2 hours on Day -5.
16260051|NCT00936936|Drug|Melphalan|50 mg/m^2 IV over 15 minutes on Days -4 to Day -2.
16260052|NCT00936936|Drug|Carboplatin|"Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2.
~Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3."
16260053|NCT00936936|Drug|Mesna|3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
16260054|NCT00936936|Drug|Ifosfamide|3,000 mg/m^2 IV over 6 hours on Days -6 to -3
16260055|NCT00936936|Drug|Etoposide|200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4.
16260056|NCT00936936|Procedure|Stem Cell Transplant|Stem cell infusion on Day 0.
16260057|NCT00936923|Drug|furosemide|patients will take furosemide 60 or 120mg oral per day for 1 years .
16260058|NCT00936910|Drug|amphotericin B liposomal (Ambisome)|After enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing sufficient amphotericin B liposomal (Ambisome [2 mg/ml]) lock solution into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days (largest CVC = 2.3 mL).
16260059|NCT00936897|Drug|Ibandronate|Ibandronate 150mg PO QM (tablet)
16260060|NCT00936897|Drug|Denosumab|denosumab 60mg SC Q6M (pre-filled syringe)
16260061|NCT00936884|Drug|Methylnaltrexone|"Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg.
~Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments)."
16260062|NCT00936884|Drug|Placebo|"Subjects received matching placebo injections.
~Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments)."
16260063|NCT00936871|Drug|Lersivirine|Lersivirine 2400 mg single dose
16260064|NCT00936871|Drug|Placebo|Placebo single dose
16260065|NCT00936871|Drug|Lersivirine (if necessary)|Lersivirine 2100 mg single dose (if necessary)
16260066|NCT00936871|Drug|Lersivirine|Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
16260067|NCT00936871|Drug|Placebo|Placebo single dose
16260068|NCT00936871|Drug|Moxifloxacin|Moxifloxacin 400 mg single dose
16260070|NCT00936832|Drug|FOLFIRI regimen|
16260071|NCT00936832|Drug|fluorouracil|
16260072|NCT00936832|Drug|irinotecan hydrochloride|
16260073|NCT00936832|Drug|leucovorin calcium|
16260074|NCT00936832|Drug|sunitinib malate|
16260075|NCT00936832|Other|laboratory biomarker analysis|
16260076|NCT00936832|Other|pharmacogenomic studies|
16260077|NCT00936832|Other|pharmacological study|
16260078|NCT00936819|Biological|Plasma-Lyte A and 25% Autologous Plasma|Single dose of 8 mls given by investigator via intracoronary injection into stent of infarct-related artery
16260079|NCT00936819|Biological|Autologous EPCs|Single dose of 20 million cells in 8 mls given by investigator via intracoronary injection into stent of infarct-related artery
16260080|NCT00936819|Biological|Autologous EPCs Transfected with human eNOS|Single dose of 20 million cells in 8 mls given by investigator via intracoronary injection into stent of infarct-related artery
16260081|NCT00936793|Drug|Darunavir|
16260082|NCT00936793|Drug|Ritonavir|
16260083|NCT00936793|Drug|Beclomethasone Dipropionate HFA|
16260084|NCT00936780|Device|Infinnium-Core™ Paclitaxel eluting Coronary Stent|Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.
16260085|NCT00936767|Drug|Artemisone/Mefloquine (AmiM3)|Artemisone 4 mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4
16260086|NCT00936767|Drug|Artesunate|Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4
16260087|NCT00936754|Dietary Supplement|Brown seaweed powder|500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)
16260088|NCT00936754|Dietary Supplement|Placebo|Two capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)
16260090|NCT00936728|Other|therapeutic nutritional supplementation|Given orally
16260091|NCT00936728|Dietary Supplement|white wine|Given orally
16260092|NCT00936728|Other|questionnaire administration|Ancillary studies
16260093|NCT00936715|Drug|FTC/TDF|200/300 mg tablet administered orally once daily
16260094|NCT00936702|Drug|carboplatin|Given IV
16260095|NCT00936702|Drug|everolimus|Given PO
16260096|NCT00936702|Drug|paclitaxel|Given IV
16260097|NCT00936689|Procedure|Selective TACE via microsphere loaded with Doxorubicin|Chemoembolization with microspheres: doxorubicin (maximum dose of 75 mg x vials of microspheres) loaded with non-reabsorbable microspheres (sulfate hydrospheres) at the dose of 2 ml per vial (definitive embolization).
16260098|NCT00936689|Procedure|Selective traditional TACE|Traditional chemoembolization: epirubicin (maximum dose of 75 mg) conjugated with Lipiodol at the maximum dose of 15 ml + Spongel.
16260099|NCT00936676|Drug|rasagiline mesylate|During the Core follow-up study period, subjects will continue to receive 1 mg rasagiline once a day. During the Extended follow-up study period, only subjects who are still on rasagiline at Visit 9 will continue to receive treatment with rasagiline 1 mg per day. Tablets will be supplied by the Sponsor and given according to the label.
16260100|NCT00936663|Drug|Placebo|Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
16260101|NCT00936663|Drug|Sitagliptin|Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
16260102|NCT00936650|Drug|placebo|Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.
16260103|NCT00936650|Drug|cinacalcet|Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.
16260104|NCT00936637|Other|Extensively hydrolyzed infant formula|
16260105|NCT00936624|Drug|SOTB07|SOTB07 100mg
16260106|NCT00936624|Drug|SOTB07|SOTB07 200mg
16260107|NCT00936624|Drug|placebo|placebo
16260108|NCT00936624|Drug|montelukast|montelukast 10mg po, bid, 12week
16260109|NCT00936611|Drug|LBH589|
16260110|NCT00936598|Drug|zolpidem|Participants will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women = or > 65 years) during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.
16260111|NCT00936598|Drug|sugar pill|Participants will receive placebo (sugar) pills during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.
16260112|NCT00936585|Other|Immunologic Monitoring|blood draws and colonoscopy before and after receiving study drug
16260113|NCT00936572|Procedure|Probiotics (La1, BB536)|
16260114|NCT00936572|Biological|probiotics (La1, BB536)|
16260115|NCT00936572|Biological|placebo|Maltodoxtrin
16260116|NCT00936559|Biological|BMP-655/ACS or Standard of Care|Decision was made by Legal to withhold this information
16260117|NCT00936559|Biological|BMP-655/ACS or Standard of Care|Decision was made by Legal to withhold this information.
16260118|NCT00936559|Biological|BMP-655/ACS or Standard of Care|Decision was made by Legal to withhold this information,
16260119|NCT00936546|Drug|Rituximab|Mabthera, Rituximab 1000 mg I.V.
16260120|NCT00936533|Drug|Dysport® (Botulinumtoxin A (Btx A))|Single injection in patients´ soles with Btx A in one foot and sodium chloride in the other, with the possibility of a second injection after 12 weeks. The drug will be given in general anaesthesia after curettage of the focal hyperkeratoses. Only the areas with focal hyperkeratoses will be injected with 50 ul per injection.The active drug Btx A (Dysport®, solution for injection) has a concentration of 100 U/ml, and the maximum dose is 300 U per foot.
16260121|NCT00936533|Drug|Placebo|Placebo preparation without active compound, administered as the active drug.
16260122|NCT00936520|Drug|SAR 1118 0.1%|Daily eye drops (twice daily, ~50 microliter [uL] each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days
16260123|NCT00936520|Drug|SAR 1118 1.0%|Daily eye drops (twice daily, ~50 uL each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days
16260124|NCT00936520|Drug|SAR 1118 5.0%|Daily eye drops (twice daily, ~50 uL each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days
16260125|NCT00936507|Other|Energy Density/Portion Size|
16260126|NCT00936494|Procedure|Cold ablation inferior turbinate reduction|The procedure usually takes 30 minutes and involves the surgeon inserting the coblation inferior turbinate reduction wand into the inferior turbinates and allowing for the radiofrequency cold ablation to ablate soft tissues, with a resultant thermal lesion allowing for additional soft tissue attenuation and contracture with time.
16260127|NCT00936468|Biological|Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone|One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.
16260128|NCT00936442|Drug|Anastrozole|(Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice.
16260129|NCT00936442|Other|Educational materials|Reception of educational material on regular basis.
16260130|NCT00936429|Biological|DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)|3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
16260131|NCT00936429|Biological|Placebo for DEN1-80E|3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.
16260132|NCT00936416|Procedure|Inulin and PAH clearance and MRI|"GFR and renal blood flow estimation by Inulin and PAH clearance will be performed in the Renal Physiology Lab for approximately 2.5 hours;
~The MRI test will be performed afterwards at Medical Imaging department and last about 45 minutes."
16260133|NCT00936403|Drug|NNC126-0083|One single dose administered in four dose levels in an escalating order
16260134|NCT00936403|Drug|somatropin|A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
16260135|NCT00936390|Drug|bicalutamide|Given orally
16260136|NCT00936390|Drug|buserelin|Given subcutaneously or as an injection
16260137|NCT00936390|Drug|flutamide|Given orally
16260138|NCT00936390|Drug|goserelin acetate|Given subcutaneously or as an injection
16260139|NCT00936390|Drug|leuprolide acetate|Given subcutaneously or as an injection
16260140|NCT00936390|Drug|triptorelin|Given subcutaneously or as an injection
16260141|NCT00936390|Radiation|3-dimensional conformal radiation therapy|Given as external-beam radiation therapy
16260142|NCT00936390|Radiation|intensity-modulated radiation therapy|Given as external-beam radiation therapy
16260143|NCT00936377|Drug|Dexmedetomidine|Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
16260144|NCT00936377|Other|Placebo|Normal saline for five days.
16260145|NCT00936364|Other|Short-term fasting|No calories will be consumed during periods of fasting. Good oral hydration will be encouraged. Water may be consumed, as well as non-caloric beverages (i.e. zero calorie soft drinks, black coffee or tea).
16260146|NCT00936364|Other|Modified fast|Minimal caloric intake on days -2 and -1
16260147|NCT00936364|Other|Fasting|Day -1
16260148|NCT00936364|Other|Fasting|Days -2 and -1
16260149|NCT00936364|Other|Fasting|Days -3, -2, and -1
16260150|NCT00936364|Other|Fasting|48-hour fast with minimal caloric intake on days -2 and -1
16260151|NCT00936351|Behavioral|Mindfulness Meditation|Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment.
16260152|NCT00936351|Behavioral|Support Group (control)|A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion.
16260153|NCT00936338|Behavioral|splint and joint mobilization self exercise|
16260154|NCT00936299|Drug|Bupropion|Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy
16260155|NCT00936299|Other|Placebo|
16260156|NCT00936286|Device|SpiroTiger|Respiratory muscle training with SpiroTiger device, 1 week training initiation and 4 weeks training period with 5 training days per week, training duration 30 min each. Respiratory bag volume set at 50% VC, respiratory frequency starting from 50% MVV. Weekly control trainings.
16260157|NCT00936260|Drug|alendronate|several duration of treatment
16260158|NCT00936247|Drug|HES 130/0.42 + electrolyte solution|Tetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component
16260159|NCT00936247|Drug|Albumin + electrolyte solution|Albumin 5% as colloid component and NaCl 0.9% as electrolyte component
16260160|NCT00936234|Drug|Vildagliptin|Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo
16260161|NCT00936221|Drug|AZD6244|oral capsules, 75mg twice daily
16260162|NCT00936221|Drug|Dacarbazine|1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
16260163|NCT00936221|Drug|Placebo|Placebo
16260164|NCT00936195|Drug|Efavirenz-Tenofovir-Emtricitabine|Atripla (R) : Efavirenz 600 mg - Tenofovir 300 mg - Emtricitabine 200 mg; Dosage : 1 pill/day
16260165|NCT00936195|Drug|Zidovudine-Lamivudine-Lopinavir/Ritonavir|"Combivir (R) : Zidovudine 300 mg - Lamivudine 150 mg Dosage : 1 pill twice a day
~Kaletra (R) or Aluvia (R) : Lopinavir 200 mg / Ritonavir 50 mg Dosage : 2 or 3 pills twice a day"
16260166|NCT00936182|Drug|Fluconazole|Fluconazole daily for 30 days
16260167|NCT00936169|Procedure|IVUS optimised DES implantation|Ivus optimised stent implantation
16260168|NCT00936169|Procedure|angiographically guided DES implantation|angiographically guided DES implantation
16260169|NCT00936156|Drug|Chemotherapy (carboplatin, etoposide, thiotepa)|Conventional chemotherapy: carboplatin injection (160 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Etoposide injection (100 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Double intensification by high-dose chemotherapy followed by autologous PBSC rescue: thiotepa injection (200 mg/m²/day as an infusion over one hour in 200 ml/m² of 5 % GS) administered from D42 to D44 and from D63 to D65. Autologous PBSC rescue on D47 and D68. Surgical resection of any tumor residue. Irradiation of the primary tumor site and cerebrospinal axis: 54 Gy to primary tumor, 36 Gy to cerebrospinal axis. Maintenance treatment: Temozolomide 150 mg/m²/day orally for 5 days every 28 days, from 1 month after the end of irradiation. 6 cycles planned. Duration of treatment: 13 months
16260170|NCT00936143|Drug|infliximab|100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
16260171|NCT00936130|Procedure|Laparoscopic Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass surgery
16260172|NCT00936130|Procedure|Laparoscopic gastric banding|Laparoscopic gastric banding surgery
16260173|NCT00936130|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy surgery
16260174|NCT00936130|Behavioral|Low Calorie Diet|Low Calorie Diet Program
16260175|NCT00936117|Drug|Posaconazole|200 mg (liquid) by mouth 3 times per day.
16260176|NCT00936091|Drug|vitamin A supplements|gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
16260177|NCT00936091|Drug|Placebo|125 children received placebo capsules
16260178|NCT00936065|Drug|Etanercept|Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
16260179|NCT00936065|Drug|Etanercept + Acitretin|Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
16260180|NCT00936065|Drug|Acitretin|Acitretin at a dose of 10mg BID for 24 weeks
16260207|NCT00935805|Drug|Glybenclamide|10 mg BID
16260208|NCT00935805|Drug|NPH insulin|Variable SC dose
16260209|NCT00935805|Drug|Hydrochlorothiazide|25 mg QD introduced as initial therapy for hypertension
16260210|NCT00935805|Drug|Propranolol|40 mg BID
16260181|NCT00936052|Other|Hyperbaric Oxygen Therapy|in addition to standard radiation and chemotherapy, you will also receive the experimental hyperbaric treatment prior to each radiation treatment (Monday-Friday) during the initial six weeks of treatment. Prior to the first hyperbaric treatment. The hyperbaric treatment lasts approximately thirty minutes. During the hyperbaric treatment, the participant will lie on a stretcher in the hyperbaric chamber and breathe oxygen at greater than normal atmospheric pressure. The investigator will monitor the increased oxygen levels in the tissue by placing a noninvasive electrode on your skin. After each hyperbaric treatment, we will measure your blood sugar by finger-stick to check for hypoglycemia (low blood sugar). If detected, hypoglycemia will be treated by standard medical measures.
16260182|NCT00936039|Behavioral|unloading|2 weeks of unloading of a single leg
16260183|NCT00936026|Drug|Neramexane|Drug-Drug Interaction Study
16260184|NCT00936013|Drug|oseltamivir|75mg p.o Bid for 5 days
16260185|NCT00936013|Drug|oseltamivir and chinese medicinal herbs|oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days
16260186|NCT00936000|Dietary Supplement|Protandim|The dosage of Protandim will be 1350 mg per day given p.o. in two equally divided doses
16260187|NCT00935987|Drug|CYT387|"For the Part 1 dose-escalation portion of the study, patients will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 100 mg/day. CYT387 will be orally self-administered as a single daily dose beginning on Day 1 of the study, and thereafter at approximately the same time each day of the 28-day cycle. It is recommended that all doses be preceded by a 2-hour fast from food and beverages, and be followed by a 1-hour post-dose fast from food and beverages.
~Twenty additional patients will be assigned to a 150 mg BID (twice daily) dosing schedule. CYT387 will be orally self-administered twice-daily with doses approximately 10-12 hours apart beginning on Day 1 of the study, and thereafter at approximately the same times each day of the 28-day cycle.
~For the Part 2 dose confirmation portion of the study, patients will be assigned to either 150 mg or 300 mg QD (once daily) dose groups."
16260188|NCT00935961|Drug|RAD001 + docetaxel + cisplatin|Patients will receive daily RAD001 (everolimus, per dose escalation scheme) plus concurrent docetaxel (75 mg/m2 intravenously every 3 weeks) + cisplatin (75 mg/m2 intravenously every 3 weeks). Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle. Patients will be followed for toxicity for 30 days after the last dose of RAD001. Patients should undergo re-staging imaging studies within 2 - 6 weeks after the final treatment with cisplatin/docetaxel. After the completion of induction chemotherapy and the 30-day observation period after treatment, patients are removed from the study.
16260189|NCT00935948|Drug|Imescard compound water smartweed ointment|Patients in this arm were instructed to apply the ointment after waking up, after evacuations and before bedtime, for 5 days.
16260190|NCT00935948|Drug|Placebo|Patients in this arm received placebo, with the exact same appearance of the Imescard ointment, and were instructed to apply it at the same intervals and period.
16260191|NCT00935922|Dietary Supplement|Flaxseed|Flaxseed omega-3 fatty acids and lignans
16260192|NCT00935896|Procedure|Low tidal volume|twenty patients were randomly (opaque sealed envelopes) assigned to receive mechanical ventilation in volume-controlled mode either with VT of 10-12 ml/kg predicted body weight (high VT group, n=10) or with VT of 5-7 ml/kg predicted body weight (low VT group, n=10) with an inspiratory fraction of oxygen (FIO2) set at the minimal level at which an arterial oxygen saturation of > 90% and minimal PEEP (4-5cmH2O). The predicted body weight of male patients was calculated as equal to 50+0.91(centimeters of height-152.4); that of female patients was calculated as equal to 45.5+0.91(centimeters of height-152.4).
16260193|NCT00935896|Procedure|Low tidal volume|Immediately after ICU admission, once all inclusion and exclusion criteria were met and consent obtained, twenty patients (16 men, 4 women, median age of 49 yrs) were randomly (opaque sealed envelopes) assigned to receive mechanical ventilation in volume-controlled mode either with VT of 10-12 ml/kg predicted body weight (high VT group, n=10) or with VT of 5-7 ml/kg predicted body weight (low VT group, n=10) with an inspiratory fraction of oxygen (FIO2) set at the minimal level at which an arterial oxygen saturation of > 90% and minimal PEEP (4-5cmH2O). The predicted body weight of male patients was calculated as equal to 50+0.91(centimeters of height-152.4); that of female patients was calculated as equal to 45.5+0.91(centimeters of height-152.4)
16260194|NCT00935896|Other|low tidal volume|tidal volume of 5-7 ml/kg predicted body weight
16260195|NCT00935883|Drug|Eculizumab|"Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).
~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
16260196|NCT00935883|Drug|Saline|"Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).
~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.
~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
16260197|NCT00935870|Device|Bioactive glass and/or autogenous bone|No intervention in the current study (10-year follow-up study)
16260198|NCT00935857|Device|Single Balloon Colonoscopy|Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.
16260199|NCT00935857|Device|Standard Colonoscopy|Use of the standard adult colonoscope to complete colonoscopy.
16260200|NCT00935844|Drug|TAK-901|"This study consists of three sequential parts.
~Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
~Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
~Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2."
16260201|NCT00935831|Drug|GSK1278863A|50mg, 150mg
16260202|NCT00935831|Drug|Placebo|matching placebo
16260203|NCT00935818|Drug|Varenicline|varenicline - 1 mg bid for 12 weeks
16260204|NCT00935818|Drug|placebo|placebo for 12 weeks
16260205|NCT00935818|Drug|bupropion SR|bupropion sr - 150 mg bid for 12 weeks
16260215|NCT00935766|Drug|Omega-3|Subjects meeting eligibility criteria will be randomized to receive a supply of omega-3-acid ethyl esters or placebo, and instructed to take 4 capsules daily. A 3-month supply of study drug will be given following randomization and at 3, 6, and 9 months. Subjects will be asked to bring unused supplies to each quarterly visit for ascertainment of adherence.
16260216|NCT00935766|Drug|Placebo|
16260217|NCT00935753|Drug|sapropterin|oral 100mg tablets taken intact or dissolved in water or apple juice with morning meal for up to 60 days
16260218|NCT00935727|Other|Elastographic imaging|ultrasound imaging using a specialized computer that processes the data for tissue hardness
16260219|NCT00935714|Other|Exercise|
16260220|NCT00935714|Other|Exercise|
16260221|NCT00935701|Device|Acupressure and Acupuncture|Acupressure involves the stimulation of specific acupoints by firm pressure, while acupuncture involves the insertion of very fine needles (the size of a strand of hair). The needles may be quickly inserted and removed or left in up to 5 minutes at a time.
16260222|NCT00935688|Other|Rapid diagnostic test|Dual species test for P. vivax and P. falciparum malaria
16260223|NCT00935675|Drug|Escitalopram|Escitalopram 10 mg once a day
16260224|NCT00935662|Drug|AZD8329|Oral solution, single ascending doses
16260225|NCT00935662|Drug|Placebo|Oral solution, placebo
16260226|NCT00935649|Device|PinPointe FootLaser|Medical laser
16260227|NCT00935623|Biological|Malaria Challenge|Malaria challenge
16260228|NCT00935610|Dietary Supplement|Immunocal|20 grams per day of Immunocal for 135 days.
16260229|NCT00935610|Dietary Supplement|Casein|20 grams per day for 135 days
16260230|NCT00935597|Biological|MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)|Patients who have minimal residual disease or minimal volume relapse, and are at least four weeks post immunosuppression following allogeneic stem cell transplantation will receive a series of four HDC infusions (100,000 HDC/kg per infusion, one every four weeks(group 1). Those patients who have greater than minimal residual disease will receive HDC infusions, one every four weeks in conjunction with donor lymphocyte infusion (DLI) (group 2).
16260231|NCT00935584|Behavioral|Physician training in patient-centered emr use|This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.
16260232|NCT00935571|Drug|propofol, remifentanil, sevoflurane|Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)
16260233|NCT00935558|Biological|DC vaccine|DC vaccination regime consist of primary 10 intradermal injections of 1-2 weeks interval. At the time of each vaccine 6 MIU/m² IL-2 will be administered sc. Zadaxin 1.6 mg is injected sc twice a week. and tablet Aromatase inhibitor is administered ; Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily
16260234|NCT00935558|Drug|aromatase inhibitor|Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily
16260235|NCT00935545|Biological|Montanide|Montanide is an oil-based immunoadjuvant similar to Incomplete Freund´s Adjuvant, which is commonly used in combination with peptide vaccines. Although its precise mode of action is not known, it acts to enhance the immune response to vaccination. It has a depot effect that depending on the type of emulsion will release the antigen slowly from the injection site.
16260236|NCT00935532|Drug|exenatide once weekly|subcutaneous injection, 2.0mg, once a week;
16260237|NCT00935532|Drug|insulin glargine|subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
16260238|NCT00935519|Device|4th generation ceramic bearing composite ceramic bearing|THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 5 years follow-up.
16260239|NCT00935506|Drug|Clopidogrel|Tablets, Oral, 75 mg, Once daily, 8 days
16260240|NCT00935506|Drug|Aspirin|Tablets, Oral, 325 mg, Once daily, 8 days
16260241|NCT00935493|Drug|Guanfacine|Guanfacine 0.1 mg po qhs
16260242|NCT00935493|Drug|Guanfacine|Guanfacine 0.5 mg po qhs
16260243|NCT00935493|Drug|Placebo|Placebo po qhs
16260244|NCT00935480|Drug|Isentress®|P.O, 1 tablet containing 400 mg every 12 hours
16260245|NCT00935480|Drug|Celsentri®|p.o.: 1 tablet containing 150 mg morning and evening (due to combination with PI/r) or containing 300 mg if fosamprenavir/r is used as the PI (MA)
16260246|NCT00935467|Drug|Saxagliptin|Tablets, oral, 2.5 mg, twice daily, 7 days
16260247|NCT00935454|Procedure|Hepatocyte matrix implantation|"First operation:
~Removal of liver tissue and biopsy of pancreas
~Second operation:
~Implantation of hepatocyte matrix implant into small bowel mesentery"
16260248|NCT00935441|Behavioral|case management with telemonitoring|telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
16260249|NCT00935441|Behavioral|usual case management|telephone contact with a case manager
16260250|NCT00935415|Drug|Montelukast|Montelukast 5 mg
16260251|NCT00935415|Drug|Placebo|capsules of matching placebo
16260252|NCT00935402|Behavioral|Sleep|Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.
16260253|NCT00935389|Drug|tripterygium glycosides|The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.
16260254|NCT00935376|Behavioral|Sleep Education Program|Treatment as usual.
16260255|NCT00935376|Behavioral|Mind-Body Bridging Program|Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
16260256|NCT00935376|Behavioral|Mindfulness Meditation Program|Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.
16260257|NCT00935363|Drug|glyburide|single oral dose
16260258|NCT00935363|Drug|glyburide + fluconazole|single dose oral glyburide single dose iv fluconazole
16260259|NCT00935363|Drug|glyburide + rifampin|single dose oral glyburide single dose iv rifampin
16260260|NCT00935363|Drug|glyburide + fluconazole + rifampin|single dose oral glyburide single dose iv fluconazole single dose iv rifampin
16260261|NCT00935350|Dietary Supplement|PolyGlycopleX (PGX)|2.5 grams of PGX
16260262|NCT00935350|Dietary Supplement|PolyGlycopleX (PGX)|5.0 grams of PGX
16260263|NCT00935350|Dietary Supplement|PolyGlycopleX (PGX)|0 grams of PGX
16260264|NCT00935337|Behavioral|Mind-Body Bridging Program|Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
16260265|NCT00935337|Behavioral|Sleep Hygiene|treatment as usual
16260266|NCT00935311|Drug|ABT-712 Extended-release|ABT-712 extended-release tablet
16260267|NCT00935311|Drug|Hydrocodone/Acetaminophen Immediate-release|Hydrocodone/acetaminophen immediate-release tablet
16260268|NCT00935311|Drug|Placebo|Placebo tablet
16260269|NCT00935298|Drug|Tacrolimus|The genotyping of gene CYP3A5 will be carried out in the 4-7days before renal transplantation. After transplantation, the patients will be treated by MMF, corticosteroids and tacrolimus at a dosage adapted to their genotype(CYP3A5*1/*1 type and CYP3A5*1/*3 type administer 0.15mg/kg/d，CYP3A5*3/*3 type administer 0.08mg/kg/d).
16260270|NCT00935272|Device|Restylane®|Restylane® injections in the lips
16260271|NCT00935272|Device|Non-Treatment|Non- Treatment
16260272|NCT00935259|Drug|Simvastatin|40 mg once daily for 2 weeks
16260273|NCT00935259|Drug|Placebo|Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
16260274|NCT00935246|Drug|Escitalopram|Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose
16260275|NCT00935233|Genetic|DNA analysis|
16260276|NCT00935233|Genetic|polymorphism analysis|
16260277|NCT00935233|Genetic|protein analysis|
16260278|NCT00935233|Other|laboratory biomarker analysis|
16260279|NCT00935233|Other|questionnaire administration|
16260280|NCT00935233|Other|survey administration|
16260281|NCT00935220|Drug|linagliptin QD (once daily) for 7 days|dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
16260282|NCT00935207|Other|Pediatric Pain Diary|Pain diary designed for pediatric patients
16260283|NCT00935194|Drug|oseltamivir|75mg,bid,for 5 days
16260284|NCT00935194|Other|blank|no antiviral therapy
16260285|NCT00935194|Drug|chinese medicinal herbs|200ml,p.o,qid,for 5 days
16260286|NCT00935194|Drug|oseltamivir and chinese medicinal herbs|oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days
16260287|NCT00935181|Behavioral|respiratory muscle stretching|stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc
16260288|NCT00935168|Drug|6% Hydroxy-ethyl starch (130/0.4)|Maximum dose of 50ml/kg/day of 6% hydroxy-ethyl starch (130/0.4) for intravascular volume fluid resuscitation
16260289|NCT00935168|Drug|Saline|Maximum dose of 50ml/kg/day of saline for intravascular volume fluid resuscitation
16260290|NCT00935155|Procedure|Acupuncture|Westerns style acupuncture. Twice a week for 12 weeks
16260291|NCT00935155|Procedure|exercises|Coordination, mobilizing, endurance, strength
16260292|NCT00935142|Drug|[18F]VM4-037|Bolus IV injection of [18F]VM4-037
16260293|NCT00935129|Device|OmniPod system|Patients will be treated with the OmniPod system for 12 weeks
16260294|NCT00935129|Device|Patient's conventional pump|patients will be treated with their conventional pump for 12 weeks
16260295|NCT00935116|Drug|etoricoxib|"G1 (CONTROL): Oral NSAID (diclofenac, three times a day) administrated pre-operatively and for 3 days after surgery.
~G2: Etoricoxib 120 mg, pre and post-operatively for 3 days after surgery"
16260296|NCT00935103|Behavioral|Psychoeducation|
16260297|NCT00935090|Device|3'-deoxy-3'-[18F]fluorothymidine|The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body. Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan. A urine sample may be collected at the end of the imaging of the tracer compound to analyze its breakdown products.
16260298|NCT00935077|Other|PPCM Asthma|Pharmacists collaborate with physicians to manage asthma
16260299|NCT00935077|Other|24 Month PPCM BP|Pharmacists collaborate with physicians for 24 months to manage hypertension.
16260300|NCT00935077|Other|9 Month PPCM BP|Pharmacists collaborate with pharmacists for 9 months to manage hypertension
16260301|NCT00935064|Drug|Aliskiren|Pill, 300 mg, once daily, for 6 weeks
16260302|NCT00935064|Other|Placebo|Placebo orally one tablet once a day for 6 weeks.
16260303|NCT00935051|Other|Picture + MMPs and TIMP1 at week 0 and week 4|Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4. This will allow to assess the level of MMP9, MMP13, MMP1 and TIMP1. A numeric photograph of the wound will be taken at week 0, week 4 and week 12 in order to assess wound area.
16260304|NCT00935025|Drug|AZD1305|single and multiple oral doses, extended-release capsule
16260305|NCT00935025|Drug|Placebo|single and multiple oral doses, capsule
16260306|NCT00935012|Drug|tafamidis|Once daily 20 mg oral tafamidis (soft gelatin capsule)
16260307|NCT00934999|Procedure|Burch urethropexy|Patients will undergo a Burch modified Tanagho procedure (in which the anterior vagina is suspended to Cooper's ligament bilaterally using two non-absorbable sutures).
16260308|NCT00934999|Procedure|Synthetic mid-urethral sling (TVT)|Patients will undergo a polypropylene mid urethral sling as described by the manufacture (Align, Bard Urological, Covington, GA).
16260309|NCT00934986|Other|Surface expression of functional biomarkers of the NK cell|"An extra blood sample of 40 ml is required :
~Stage A patient who does not require a treatment: one sample the day of enrollment.
~Stage B or C patient who require RFC treatment: sample at D0 of the 1st and 4th cure of RFC, and 3 months after the end of the treatment."
16260310|NCT00934973|Drug|mebeverine|overencapsulated mebeverine 135 mg tds for 6 weeks
16260311|NCT00934973|Drug|methylcellulose|overencapsulated methylcellulose 3 tablets bd for 6 weeks
16260312|NCT00934973|Drug|placebo|overencapsulated placebo tablets 1 tds for 6 weeks
16260313|NCT00934973|Behavioral|CBT website with support|cognitive behavioral therapy with nurse telephone session and email support
16260314|NCT00934973|Behavioral|No website|No CBT website
16260315|NCT00934973|Behavioral|CBT website with minimal support|
16260316|NCT00934947|Drug|Propranolol|40 mg
16260317|NCT00934947|Drug|Placebo|sugar pill
16260318|NCT00934947|Drug|Propanolol|120 mg twice per day
16260319|NCT00934934|Other|Normal Saline|Normal Saline
16260320|NCT00934934|Drug|anidulafungin|TBA
16260321|NCT00934921|Drug|Ondansetron|1 x 8 mg Orally Disintegrating Tablet
16260322|NCT00934921|Drug|Zofran®|1 x 8 mg ODT
16260323|NCT00934908|Dietary Supplement|Green Tea|Green tea capsules taken twice a day.
16260324|NCT00934908|Other|Placebo|"Non-active sugar pill."
16260325|NCT00934895|Drug|everolimus|Orally administered RAD001 will be initiated at 5 mg daily. Each cohort Phase I: administration will proceed based on escalation criteria. RAD001 will be given initially once every day. Doses will be adjusted per the dosing regimen for each cohort throughout the Phase I portion of the study
16260326|NCT00934895|Drug|abraxane|Doses of Abraxane will be calculated on Day 1 of each cycle using the patient's actual weight in the determination of body surface area. A variance of 5% of the calculated total dose will be allowed.
16260327|NCT00934882|Drug|Regorafenib (BAY73-4506)|Administration of the multi-kinase inhibitor BAY73-4506 (160 mg once daily from Day 4 to Day 10 and from Day 18 to Day 24) as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic Colorectal Cancer
16260328|NCT00934856|Drug|Docetaxel|Docetaxel will be administered on Day 1 of each 3-week cycle at a dose specified in the respective arms (as per summary of product characteristics [SmPC]).
16260329|NCT00934856|Drug|Pertuzumab|Pertuzumab at a loading dose of 840 mg IV infusion on Day 1 of Cycle 1 followed by maintenance dose of 420 mg IV infusion on Day 1 of each 3-week cycle.
16260330|NCT00934856|Drug|Trastuzumab emtansine|T-DM1 will be administered on Day 1 or Day 2 of each 3-week cycle at a dose specified in the respective arms.
16260331|NCT00934843|Drug|methylprednisolone (IVMP)|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive ONE doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP (2 dose steroid)to intraoperative IVMP alone (single dose steroid) on the inflammatory response to CPB cardiopulmonary bypass.
16260332|NCT00934843|Drug|methylprednisolone (two doses IVMP)|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive TWO doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP to intraoperative IVMP alone on the inflammatory response to CPB cardiopulmonary bypass. The hypothesis is that neonates treated with preoperative IVMP as well as the standard intraoperative IVMP will have decreased production of pro-inflammatory cytokines.
16260333|NCT00934830|Drug|Antibiotic (Amoxicillin)|500 mg, 3 times per day for 10 days
16260334|NCT00934830|Other|Therapeutic ultrasound|1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.
16260335|NCT00934817|Drug|Amaryl-M 2/500 mg|single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively
16260336|NCT00934817|Drug|Amaryl-M 1/500 mg|single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
16260337|NCT00934804|Device|Galilei dual Scheimpflug analyzer|The Galilei dual Scheimpflug analyzer is a non-invasive, diagnostic system that combines dual rotating Scheimpflug camera measurements and Placido optical system for corneal topography and 3D analysis of the anterior eye segment.
16260338|NCT00934791|Drug|Tacrolimus|Tacrolimus 6-10 mg/day (maintain trough levels of 8-10 ng/mL)
16260339|NCT00934791|Drug|Sirolimus|Sirolimus 3-5 mg/day (maintain high-performance liquid chromatography (HPLC) blood level 10-15 ng/mL)
16260340|NCT00934791|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 750 mg twice daily
16260341|NCT00934791|Drug|Prednisone|Prednisone tapered to 5 mg/day by day 92
16260342|NCT00934778|Procedure|Confocal microscopy and endocytoscopy|2 probe based imaging systems for use via the working channel of the bronchoscope. 0.5ml of methylene blue injected into airways for endocytoscopy. Each procedure takes about 2-3 minutes.
16260343|NCT00934765|Behavioral|weight loss|self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery
16260344|NCT00934752|Device|Lutonix Paclitaxel-Coated Balloon|Percutaneous transluminal coronary angioplasty (PCTA)
16260345|NCT00934739|Drug|Thalidomide, Celebrex|Immediately after operation starts thalidomide (50) 4# per day and celecoxib (Celebrex)(200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy
16260346|NCT00934739|Drug|Cyclophosphamide, Dexamethasone|Immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy
16260347|NCT00934713|Drug|montelukast|montelukast 4mg once per day for 8 weeks period
16260348|NCT00934700|Other|Xenon gas|30% Xenon gas inhaled for 24 hours
16260349|NCT00934687|Drug|clostridium botulinum toxin type A neurotoxin complex|A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
16260350|NCT00934687|Other|0.9% NaCl solution|0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
16260351|NCT00934674|Drug|SKI-606 (Bosutinib)|"Arm 1 - Commercial Tablet manufactured by Excella
~Arm 2 - Clinical Tablet manufactured by Wyeth Montreal"
16260352|NCT00934661|Drug|Extended Release Epidural Morphine (EREM)|A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline
16260353|NCT00934661|Drug|Placebo|A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
16260354|NCT00934648|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16260355|NCT00934648|Drug|methotrexate|10-25mg weekly
16260356|NCT00934635|Drug|Paliperidone ER|9 mg tablet once a day followed by PET scan in approximately 2 hours
16260357|NCT00934635|Drug|Oral risperidone|6 mg tablet once a day followed by PET scan in approximately 2 hours
16260358|NCT00934635|Other|PET Scan|PET Scan
16260359|NCT00934635|Drug|Oral risperidone|4 mg tablet once a day followed by PET scan in approximately 24 hours
16260360|NCT00934635|Drug|Oral risperidone|4 mg tablet once a day followed by PET scan in approximately 2 hours
16260502|NCT00933556|Dietary Supplement|VSL#3|6 gms of powder formulation to be given once a day for 4 weeks
16260361|NCT00934635|Drug|Paliperidone ER|6 mg tablet once a day followed by PET scan in approximately 2 hours
16260362|NCT00934635|Drug|Paliperidone ER|6 mg tablet once a day followed by PET scan in approximately 24 hours
16260363|NCT00934635|Drug|Oral risperidone|6 mg tablet once a day followed by PET scan in approximately 24 hours
16260364|NCT00934635|Drug|Paliperidone ER|9 mg tablet once a day followed by PET scan in approximately 24 hours
16260365|NCT00934622|Device|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
16260366|NCT00934609|Behavioral|Endurance training|45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks
16260367|NCT00934596|Procedure|Lund de-airing technique|In these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in the left heart (LA, LV & Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. Deairing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB. When TEE will show no air in the left heart, the de-airing will be considered complete.
16260368|NCT00934596|Drug|carbon-dioxide insufflation|In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with Co2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.At the end of the cardioplegic arrest, the de-airing procedure is similar to that in the Lund de-airing group.
16260369|NCT00934583|Behavioral|Image and Mood (IaM) program|A 10-week Internet-based intervention focused on (1) identifying and challenging automatic thoughts in order to improve body image and reduce negative affect, (2) developing adaptive emotion and behavior regulation skills associated with preventing disordered eating and negative affect, and (3) teaching relapse prevention skills. The program includes an online discussion group moderated by a study clinician.
16260370|NCT00934570|Drug|Metformin and standard exercise|Metformin 1500 mg daily for 2 years
16260371|NCT00934570|Drug|Metformin Intensive exercise|Metformin 1500 mg daily for 2 years
16260372|NCT00934570|Behavioral|Placebo Standard exercise|Standard exercise
16260373|NCT00934570|Behavioral|Intensive exercise|Placebo Intensive exercise
16260374|NCT00934557|Drug|ATG Fresenius|
16260375|NCT00934557|Drug|ATG Fresenius|
16260376|NCT00934557|Drug|ATG Fresenius|
16260377|NCT00934557|Drug|ATG Fresenius|
16260378|NCT00934557|Drug|ATG Fresenius|
16260379|NCT00934557|Drug|ATG Fresenius|
16260380|NCT00934557|Drug|ATG Fresenius|
16260381|NCT00934557|Drug|ATG Fresenius|
16260382|NCT00934544|Drug|Ruxolitinib|5 mg tablets packaged as 60-count in high-density polyethylene bottles
16260383|NCT00934544|Drug|Best Available Therapy (BAT)|Prescribing and usage per respective package inserts
16260384|NCT00934531|Drug|Donepezil|"Participants with MCI will be randomized to either the experimental (donepezil) or placebo arm of the study.
~Experimental Arm: Participants with MCI will receive 5 mg/day of donepezil p.o. for 4 weeks, and thereafter 10 mg/day of donepezil p.o. for a period of 5 months, yielding a total period of intervention of 6 months from baseline.
~Placebo Arm: Participants with MCI will receive a matched placebo p.o. for 4 weeks, and thereafter will receive a new matched placebo p.o. for the next 5 months, yielding a total period of intervention of 6 months from baseline."
16260385|NCT00934518|Radiation|Radiation|Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
16260386|NCT00934518|Drug|Cetuximab|"Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
~Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation"
16260387|NCT00934492|Drug|Cotrimoxazole dispersible tablet|Cotrimoxazole dispersible tablets 120/240mg daily for six consecutive months.
16260388|NCT00934492|Drug|Placebo dispersible tablet|Placebo dispersible tablets 120/240mg daily for six consecutive months.
16260389|NCT00934479|Drug|Lubiprostone|Following the initial stool and breath collections and because of differences in the FDA-approved dosing for the 2 subtypes of chronic constipation, (that is, chronic constipation (CC) versus constipation due to irritable bowel syndrome (C-IBS), the CC subjects received open-label lubiprostone 24 mcg orally twice daily for 4 weeks; while the C-IBS subjects received open-label lubiprostone 8 mcg orally twice daily for 4 weeks.
16260390|NCT00934466|Drug|MK2637|Single dose of 120 mg MK2637 capsules in one of five treatment periods.
16260391|NCT00934466|Drug|Comparator: MK2637|Single dose of 50 mg MK2637 capsules in one of five treatment periods.
16260392|NCT00934466|Drug|Comparator: Placebo|Single dose of placebo only in one of five treatment periods.
16260393|NCT00934466|Drug|Comparator: Dextromethorphan|Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.
16260394|NCT00934466|Drug|Comparator: Dextromethorphan|Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.
16260395|NCT00934453|Biological|Lactobacillus rhamnosus GG ATCC 53103|Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day dissolved in cow's milk or soy milk on an outpatient basis for six months.
16260396|NCT00934453|Biological|Placebo|Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day dissolved in cow's milk or soy milk on an outpatient basis for six months.
16260397|NCT00934440|Drug|Bevacizumab|"First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes.
~Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes.
~Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles)."
16260398|NCT00934440|Drug|Azacitidine|"Dose level 1: 35 mg/m2/day for 7 days.
~Dose level 2: 55 mg/m2/day for 7 days.
~Dose level 3: 75 mg/m2/day for 7 days.
~mg/m2/day = dose based on height and weight"
16260470|NCT00933868|Drug|Magnesium Chloride|An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
16260399|NCT00934427|Drug|0.9% nitroglycerin in TAM cream|0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
16260400|NCT00934427|Drug|vehicle cream|0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
16260401|NCT00934414|Drug|Technosphere Insulin Inhalation Powder|30U
16260402|NCT00934388|Procedure|Pre peritoneal mesh placement|
16260403|NCT00934388|Procedure|Laparoscopy|
16260404|NCT00934375|Drug|Aricept (donepezil hydrochloride)|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
16260405|NCT00934375|Drug|placebo|
16260406|NCT00934362|Drug|Lucinactant first|lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs
16260407|NCT00934362|Drug|Placebo first|6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours
16260408|NCT00934336|Other|Therapeutic and preventive strategies|These results may help us to define a post prandial insulin treatment regimen (which is more flexible as regards meals) or a pre prandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).
16260409|NCT00934336|Other|Therapeutic and preventive strategies|These results may help us to define a post prandial insulin treatment regimen (which is more flexible as regards meals) or a pre prandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).
16260410|NCT00934323|Drug|Amaryl M SR 1/500 mg|single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
16260411|NCT00934323|Drug|Amaryl M SR 2/500 mg|single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
16260412|NCT00934284|Other|Lumbar injection|Patients are instructed to resume normal activity as tolerated.
16260413|NCT00934284|Other|Rehabilitation following lumbar injection|Participants are referred to an average of four weeks of physical therapy after receiving a lumbar injection. Physical therapy designed to include end-range directional preference exercises and/or mechanical traction to reduce lower extremity symptoms and progress activity tolerance.
16260414|NCT00934271|Radiation|fractionated stereotactic radiotherapy|Audit of outcome
16260415|NCT00934258|Drug|rosuvastatin,fenofibrate|Rosuvastatin 10 mg once daily Rosuvastatin 5 mg + SFC fenofibrate 80 mg
16260416|NCT00934258|Genetic|CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP|All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place at months 6, 12, 18, and every year thereafter for another 3 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement
16260417|NCT00934245|Biological|Inactivated Trivalent Influenza Vaccine|Vaccine administration will occur twice, one month apart, in the first year of participation in the study. This will occur as TIV vaccine becomes available in India, in the early autumn. Subsequent years will provide one immunization. Due to the inclusion of the pandemic 2009 influenza A H1N1 virus in the 2010-2011 northern hemisphere vaccine formulation and recommendations that children should receive 2 doses of this vaccine this study will administer 2 doses of vaccine in the second year of the study.
16260418|NCT00934245|Biological|Inactivated polio vaccine (IPV)|Vaccine administration will occur twice, one month apart, in the first year of participation in the study to parallel administration of TIV (experimental intervention). Subsequent years will provide one immunization except 2011 schedule modified to accommodate changes in TIV schedule as per above..
16260419|NCT00934232|Drug|Busulfan|Busulfan (Bu) is a bifunctional alkylating agent currently used almost exclusively as a component of conditioning regimens for both autologous and allogeneic stem-cell transplants.
16260420|NCT00934219|Drug|Omega-3-Acid Ethyl Esters|LOVAZA, 1 g caps; High Dose Arm for 4 months, while on a standard therapy for hypertriglyceridemia (fibrates, +/-metformin). Standard Dose Arm for 3 months, while on a standard, unchanged therapy for hypertriglyceridemia (fibrates +/- metformin).
16260421|NCT00934206|Behavioral|Endurance training|running / walking at 60 % heart rate reserve 4 times per week for 4 weeks
16260422|NCT00934193|Drug|Gabapentin|Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
16260423|NCT00934193|Drug|Placebo|Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
16260424|NCT00934180|Drug|Ondansetron|1 x 8 mg Orally Disintegrating Tablet
16260425|NCT00934180|Drug|Zofran®|1 x 8 mg ODT
16260426|NCT00934167|Biological|heparin sodium - Hipolabor|5.000 UI/0,25mL
16260427|NCT00934167|Biological|Heparin sodium - APP|5.000 USP/mL
16260428|NCT00934154|Drug|Thalidomide|100 mg/day continuously for 12 months
16260429|NCT00934154|Drug|Melphalan+Prednisolone|Melphalan 2 mg, Prednisolone 16 mg
16260471|NCT00933868|Drug|Placebo|A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent
16260503|NCT00933556|Dietary Supplement|sugar pill (placebo)|placebo identical to the active product will be given
16260504|NCT00933543|Drug|Visonac PDT (MAL PDT)|Cream application followed by illumination with red light.
16260430|NCT00934141|Other|Learning Session|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
16260431|NCT00934141|Other|Interest Circle Calls|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach
16260432|NCT00934141|Other|Coaching|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
16260433|NCT00934141|Other|Website|The NIATx Web site features resources central to improvement. The site includes: 1) a catalog of change ideas and case studies; 2) a toolbox providing just-in-time training on topics such as conducting a walk-through and key innovations; 3) on-line tools to assess organizational (or project) readiness for and ability to sustain change; 4) electronic communication services to ask questions of experts, and participate in peer discussion groups; 5) links to relevant process improvement Web sites; and 6) a secure portion for treatment agencies to report and track progress. Hence, our control group will have access to the entire website.
16260434|NCT00934128|Device|Vapotherm|Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.
16260435|NCT00934128|Device|BIPAP|Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.
16260436|NCT00934102|Device|Narafilcon A contact lens|Investigational, silicone hydrogel, spherical soft contact lens
16260437|NCT00934102|Device|Lotrafilcon A contact lens|Commercially marketed, silicone hydrogel, spherical soft contact lens
16260438|NCT00934102|Device|Galyfilcon A contact lens|Commercially marketed, silicone hydrogel, spherical soft contact lens
16260439|NCT00934089|Drug|PF-04217329|Topical ocular solution, once-daily for 14 days
16260440|NCT00934089|Drug|latanoprost vehicle|Topical ocular solution, once-daily for 14 days
16260441|NCT00934089|Drug|PF-04217329|Topical ocular solution, once-daily for 14 days
16260442|NCT00934089|Drug|latanoprost|Topical ocular solution, once-daily for 14 days
16260443|NCT00934076|Drug|Tarceva plus AT-101|"150 mg of Tarceva taken once daily in a continuous regimen expressed in 3 week cycles.
~Oral AT-101 at 40 mg twice daily for 3 days of each 3 week cycle on an outpatient basis."
16260444|NCT00934063|Drug|somatropin|For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16260445|NCT00934063|Other|No treatment given|Control group not receiving treatment
16260446|NCT00934050|Drug|ELND005 (scyllo-inositol)|"Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks
~After 15Dec2009: ELND005 250 mg PO BID for 48 weeks"
16260447|NCT00934037|Procedure|320 Volume Detector Computed Tomography|Single Arm Study. All patients undergo Volume (Multidetector) CT.
16260448|NCT00934037|Other|Other: Multidetector Computed Tomography - 320 detectors|Multidetector computed tomography angiography
16260449|NCT00934024|Drug|varenicline|Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.
16260450|NCT00934011|Other|C-reactive protein guided antibiotic therapy|plasma CRP measurement to guide the duration of antibiotic therapy
16260451|NCT00934011|Other|Procalcitonin guided antibiotic therapy|plasma PCT measurement to guide the duration of antibiotic therapy
16260452|NCT00933998|Other|Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)|One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.
16260453|NCT00933985|Drug|dexrazoxane hydrochloride|Given IV
16260454|NCT00933985|Drug|doxorubicin hydrochloride|Given IV
16260455|NCT00933985|Drug|obatoclax mesylate|Given IV
16260456|NCT00933985|Drug|liposomal vincristine sulfate|Given IV
16260457|NCT00933985|Other|pharmacological study|Correlative studies
16260458|NCT00933985|Other|laboratory biomarker analysis|Correlative studies
16260459|NCT00933972|Drug|RO4998452|20mg po single dose
16260460|NCT00933959|Behavioral|Mind-Body Bridging Program|Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
16260461|NCT00933959|Behavioral|Sleep Hygiene|Treatment as usual
16260462|NCT00933946|Drug|LACTIC ACID(ND)|Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
16260463|NCT00933933|Device|ARCHITECT HIV Ag/Ab Combo|Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.
16260464|NCT00933933|Device|ARCHITECT HIV Ag/Ab Combo|Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.
16260465|NCT00933920|Drug|Aliskiren|
16260466|NCT00933920|Drug|Aliskiren|
16260467|NCT00933907|Drug|LACTIC ACID(ND)|Treatment duration: 6 weeks
16260468|NCT00933894|Drug|Telaprevir; Escitalopram|
16260469|NCT00933881|Other|Determining a change in heart rate variability post delivery of the baby|Determining a change in heart rate variability post delivery of the baby
16260472|NCT00933855|Behavioral|Questionnaires and training workshop|"We will recruit a minimum of 1 and maximum of 12 patients for each workshop.
~The workshop will follow the approximate time table below:
~10 minutes: Sign-in, welcome and introductions 25 minutes: Didactic session, videos and discussion 10 minutes: Group discussion 15 minutes: Closing plenary and final assessment"
16260473|NCT00933842|Drug|LACTIC ACID(ND)|Treatment duration: 5 weeks
16260474|NCT00933829|Procedure|Absorbable Suture Arm|use of irradiated polyglactin 910
16260475|NCT00933829|Device|Non-absorbable suture (Prolene)|suture
16260476|NCT00933829|Procedure|suture|non-absorable sutures and absorable sutures
16260477|NCT00933816|Drug|sorafenib, cisplatin, fluorouracil|Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued.
16260478|NCT00933790|Drug|ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)|Ethambutol 800 mg for daily, 1200 mg for intermittent therapy, Pyrazinamide 1500 mg for both daily and intermittent, INH 300 mg for daily and 600 mg for intermittent therapy, Rifampicin 450 mg for both daily and intermittent therapy for patients below 60 kg, 600 mg for both daily and intermittent therapy for patients 60 kg and above
16260479|NCT00933777|Drug|Combination of sorafenib and everolimus|Dose finding: Treatment with defined dose of sorafenib of 2x400 mg with increasing dose of everolimus (2.5 mg, 5 mg, 7.5 mg, 10 mg) Extension: Treatment with defined dose of sorafenib of 2x400 mg with everolimus 7.5 mg
16260480|NCT00933751|Device|Central vein catheterization|Blood samplings from IVC catheter
16260481|NCT00933725|Other|TCM intervention|"Drug: Particle of compound Chinese herbs(produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
~One tablet placebo of Tibolone (provided by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months.
~Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months."
16260482|NCT00933725|Other|Western intervention|"Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
~Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months."
16260483|NCT00933712|Drug|LACTIC ACID(ND)|Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.
16260484|NCT00933699|Drug|LACTIC ACID(ND)|Treatment duration: 21 consecutive days
16260485|NCT00933686|Drug|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9.
16260486|NCT00933686|Drug|Placebo and Saizen®|Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9.
16260487|NCT00933673|Drug|L-asp, DXM, IFO, VP-16, DDP|L-asp 6000 u/m2; DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 60 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
16260488|NCT00933660|Other|ERC-training by instructor|Standard way of training with an instructor
16260489|NCT00933660|Other|Web-based training only|Experimental way of training with a web based training application
16260490|NCT00933660|Other|Web-based training with a personal training manikin|Experimental way of training with a web based training application and a simple personal training manikin
16260491|NCT00933647|Dietary Supplement|Yerba Mate Tea|Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
16260492|NCT00933647|Dietary Supplement|Green tea|Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
16260493|NCT00933647|Dietary Supplement|Apple tea|Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
16260494|NCT00933634|Procedure|electrical cardioversion|External cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula); patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.
16260495|NCT00933634|Drug|propafenone|Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.
16260496|NCT00933621|Procedure|Autologous bone marrow intracoronary infusion|Percutaneous intracoronary mononuclear bone marrow cell infusion
16260497|NCT00933608|Drug|memantine|participants will be asked to take memantine (20mg/day) for 16 weeks
16260498|NCT00933608|Drug|Placebo|participants will be asked to take 2 tablets per day to match active drug
16260499|NCT00933595|Other|Smoking Cessation|"A Motivational Interview session (~40-50 minutes) will be delivered by a trained nurse coordinator.
~Treatment with varenicline (1 mg daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12)or nicotine replacement therapy (21 mg of a skin patch + nicotine gum 4 mg ad lib added for breakthrough craving up to 20 pieces/day."
16260500|NCT00933582|Drug|JNJ-39439335; Placebo; Naproxen|
16260501|NCT00933569|Drug|LACTIC ACID(ND)|treatment period: 21 consecutive days
16260505|NCT00933543|Drug|Vehicle cream (placebo)|Cream application followed by illumination with red light.
16260506|NCT00933543|Procedure|PDT|Photodynamic Therapy - Light dose 37 J/cm2
16260507|NCT00933530|Drug|SRT2104|SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, or 3.0 g/day) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. The dosing vehicle is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.
16260508|NCT00933530|Drug|Placebo|Placebo (at the matched dosage as SRT2104) will be supplied as a powder which will be prepared by the Pharmacist/designee into a liquid suspension. Placebo will consist of titanium dioxide USP and prepared for oral administration identically to the SRT2104 investigational product. Test material will be administered orally, in a single dose and subsequently, once daily for seven consecutive days. The subjects enrolled will be blinded to treatment assignment. A trained staff member will prepare individual solutions of test material that the subject will drink once daily in the clinic following a 10-hour (minimum) fast.
16260509|NCT00933517|Drug|vectibix|9mg/kg at D1 of each 21-days cycle
16260510|NCT00933517|Drug|fluorouracile|500 mg/m2 at D1 of each 21-days cycle
16260511|NCT00933517|Drug|Epirubicine|100 mg/m2 at D1 of each 21-days cycle
16260512|NCT00933517|Drug|cyclophosphamide|500 mg/m2 at D1 of each 21 dyas cycle
16260513|NCT00933517|Drug|docetaxel|100 mg/m2 at D1 of each 21 days cycle
16260514|NCT00933504|Drug|LACTIC ACID(ND)|Treatment duration: 6 weeks.
16260515|NCT00933478|Device|Clay|Small dime sized piece of clay.
16260516|NCT00933465|Drug|Imodium (Loperamide Hydrochloride) syrup|"syrup (orally), max dose per day; 16x 5ml spoonfuls (80ml) Titrated from low dose to clinically relevant dose as described by the patient and their symptoms.
~Taken at times suitable for the patient, either at regular intervals as defined by patient needs, or as single dose when needed the most."
16260517|NCT00933465|Drug|Imodium (Loperamide hydrochloride) tablets|"tablets (orally) max dose per day; in chronic diarrhea, 8 capsules (16 mg) titrated from low dose to clinically relevant dose as described by patient and their symptoms.
~Taken at times suitable for the patient, either at regular intervals as defined by patient needs, or as single dose when needed the most"
16260518|NCT00933452|Drug|duloxetine|30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days
16260519|NCT00933452|Drug|duloxetine|15mg, oral administer
16260520|NCT00933452|Drug|duloxetine|60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine
16260521|NCT00933439|Drug|Duloxetine|Approximately 30 participants with major depressive disorder and concentration and/or cognition difficulties, recruited from the community and physician referrals, will be treated with duloxetine for 12 weeks. Their cognitive performance will be assessed pre- and post-treatment with a cognitive testing battery.
16260522|NCT00933426|Drug|Lenalidomide|Lead-In beginning dose of 5 mg capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28) for a 28 day cycle.
16260523|NCT00933426|Drug|Paclitaxel|50 mg/m^2 given by vein over 1 hour on Days 1, 8, and 15 of each 28 day cycle.
16260524|NCT00933413|Drug|LACTIC ACID(ND)|Treatment duration: 21 consecutive days
16260525|NCT00933400|Procedure|CT Coronary Angiography|CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.
16260526|NCT00933400|Procedure|Traditional, Standard of Care|Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
16260527|NCT00933387|Drug|Cetuximab,Paclitaxel,Cisplatin|Cetuximab 500 mg/m2 iv infusion (120 min for the 1st infusion, 90 min for the 2nd , and 60 min for the subsequent) Paclitaxel 120 mg/m2 3-hour iv infusion Cisplatin 50 mg/m2 2-hour iv infusion
16260528|NCT00933374|Drug|paclitaxel|Paclitaxel (175 mg/m3)will be administered as a 3 hour continuous IV infusion after standard premedication every 3 weeks
16260529|NCT00933374|Drug|RAD001|10 mg RAD001 once daily starting at day 1 of a 21 days treatment cycle
16260530|NCT00933361|Drug|ghrelin|As starting dose the investigators choose a dose level which was shown in our last study to be safe in human beings, i.e. 8μg/kg intravenously. With an assumed bioavailability of 25% of subcutaneously administered ghrelin the corresponding dose for dose level 1 is therefore 32 μg/kg. In the first 4 dose levels for each subsequent dose level the dose is increased by 50% compared to the previous one, from the 5th dose level onwards the increase is 25%: Dose level 1 = 32 μg/kg Dose level 2 = 48 μg/kg Dose level 3 = 72 μg/kg Dose level 4 = 108 μg/kg Dose level 5 = 135 μg/kg Dose level 6 = 169 μg/kg Dose level 7 = 211 μg/kg The investigators define the maximum tolerable dose as 20mg ghrelin (equivalent to 5ml) for reasons of the high drug volume to be administered subcutaneously.
16260531|NCT00933348|Drug|OPAL A|OPAL A will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the OPAL A Filtrate will only be administered once every 72 hours.
16260532|NCT00933348|Drug|Placebo|Placebo will be supplied in two formulations: as a Filtrate (0.5 mL per cm2 of ulcer area, applied into the ulcer cavity) and as a Cream (about 1 to 5 g applied as a thin smear on surrounding skin). Both formulations will be applied daily. However, if the ulcer begins to hypergranulate, the Placebo Filtrate will only be administered once every 72 hours.
16260533|NCT00933335|Biological|Tositumomab and Iodine I 131 Tositumomab|Tositumomab and Iodine I 131 Tositumomab
16260582|NCT00932997|Procedure|psychosocial assessment and care|"Participants receive a Survivorship Kit alone or in combination with telephone sessions based upon responses to initial survey"
16260534|NCT00933322|Dietary Supplement|diet enriched with industrial trans fatty acids|After run-in phase of 2 weeks with margarine without TFA, 4 weeks with margarine enriched with industrial trans fatty acids following. TFA-percentage of total energy consumption is 2% or 6% of total fat energy consumption.
16260535|NCT00933322|Dietary Supplement|diet enriched with ruminant trans fatty acids|After run-in phase of 2 weeks with margarine without TFA, 4 weeks with butter enriched with ruminant trans fatty acids following. TFA-percentage of total energy consumption is 2% or 6% of total fat energy consumption.
16260536|NCT00933322|Dietary Supplement|diet without any trans fatty acids|6 weeks with margarine without any trans fatty acids.
16260537|NCT00933309|Drug|Exemestane|25 mg tablets orally once a day
16260538|NCT00933309|Drug|Avandamet|Beginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day
16260539|NCT00933283|Drug|Telaprevir|Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily.
16260540|NCT00933283|Drug|Methadone|Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days.
16260541|NCT00933270|Device|SUPERA® Nitinol Stent System|Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA
16260542|NCT00933257|Drug|LACTIC ACID(ND)|Treatment duration 5 weeks
16260543|NCT00933244|Dietary Supplement|High Dose Vitamin D3|Yellow gel-cap vitamin D3 at 50,000 International Units daily for 15 days then two times a month for 350 days. Daily white placebo pills.
16260544|NCT00933244|Dietary Supplement|Low Dose Vitamin D3|White gel-cap vitamin D3 at 800 International Units to take orally, daily for 365 days. Intermittent yellow placebo pills.
16260545|NCT00933244|Dietary Supplement|Placebo|Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days. White gel-cap placebo pills once daily for 365 days.
16260546|NCT00933231|Drug|tacrolimus|Standard dose, Oral
16260547|NCT00933231|Drug|tacrolimus|Low dose, Oral
16260548|NCT00933231|Biological|Simulect|IV
16260549|NCT00933231|Drug|Cellcept|Oral
16260550|NCT00933231|Drug|Corticosteroids|IV and Oral
16260551|NCT00933231|Drug|Ramipril|Oral
16260552|NCT00933231|Drug|Irbesartan|Oral
16260553|NCT00933218|Dietary Supplement|polyphenols (non-alcoholic beer)|1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run
16260554|NCT00933218|Dietary Supplement|beverage without polyphenols|1.0 - 1.5 l of beverage without polyphenols (otherwise the same composition as non-alcoholic beer) per day; 3 weeks before and during a marathon run
16260555|NCT00933205|Drug|Tipranavir|
16260556|NCT00933192|Device|Siemens Acuson Antares ultrasound|skeletal muscle ultrasound of the musculus quadriceps, on two different days, two observers
16260557|NCT00933179|Drug|Gestodene/EE Patch (BAY86-5016)|21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
16260558|NCT00933179|Drug|EE/Levonorgestrel (Microgynon, BAY86-4977)|21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
16260559|NCT00933166|Device|Lotrafilcon A contact lens|Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months
16260560|NCT00933153|Dietary Supplement|Ensure Plus|Ensure plus supplement with meals
16260561|NCT00933153|Dietary Supplement|Meals on Wheels|Two Meals on Wheels twice daily
16260562|NCT00933127|Genetic|DNA analysis|
16260563|NCT00933127|Genetic|polymerase chain reaction|
16260564|NCT00933127|Genetic|polymorphism analysis|
16260565|NCT00933127|Other|laboratory biomarker analysis|
16260566|NCT00933114|Procedure|MRI and PET imaging|Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy
16260567|NCT00933088|Other|questionnaires|"The study instruments will be given in the following order to the adolescent daughters: 1. Responses to Stress questionnaire; 2. Inventory of Peer and Family Attachment; 3. Youth Self-Report; and, 4. Adolescent data form.
~Mothers will be asked to complete data form."
16260568|NCT00933075|Drug|LACTIC ACID(ND)|Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).
16260569|NCT00933062|Drug|SRT2104|2.0 g of SRT2104 will be supplied in hard gelatin capsules each containing 250 mg SRT2104. SRT2104 will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of SRT2104 will be orally-administered with approximately 200 mL water.
16260570|NCT00933062|Drug|Placebo|Placebo will be supplied in hard gelatine capsules containing an appropriate amount of placebo. Placebo will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of placebo will be orally-administered with approximately 200 mL water.
16260571|NCT00933049|Drug|Amoxicillin|Oral amoxicillin (25mg/kg/dose)for 5 days
16260572|NCT00933049|Drug|Cotrimoxazole|Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole)
16260573|NCT00933049|Drug|Amoxicillin placebo|
16260574|NCT00933049|Drug|Cotrimoxazole placebo|
16260575|NCT00933036|Device|Crosstrees Pod system for PVA|Minimally invasive spine surgery
16260576|NCT00933023|Drug|hydrocortisone|1%hydrocortisone topical once daily for 8 weeks
16260577|NCT00933023|Drug|Betamethasone|Betamethasone 0.1% topical once daily for 8weeks
16260578|NCT00932997|Behavioral|telephone-based intervention|"Participants receive a Survivorship Kit and telephone sessions based upon responses to initial survey"
16260579|NCT00932997|Other|counseling intervention|"Participants receive a Survivorship Kit and telephone sessions based upon responses to initial survey"
16260580|NCT00932997|Other|educational intervention|"Participants receive a Survivorship Kit alone or in combination with telephone sessions based upon responses to initial survey"
16260581|NCT00932997|Other|questionnaire administration|Baseline and 9 months after enrollment and intervention
16260583|NCT00932997|Procedure|quality-of-life assessment|Baseline and 9 months after enrollment and intervention
16260584|NCT00932984|Drug|LACTIC ACID(ND)|Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).
16260585|NCT00932971|Drug|PEG-IFN alfa-2a, Tenofovir|Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally
16260586|NCT00932971|Drug|PEG-IFN alfa-2a, placebo|Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally
16260587|NCT00932945|Drug|LACTIC ACID(ND)|Treatment duration: 21 consecutive days
16260588|NCT00932919|Behavioral|Thought field therapy|5 sessions with Thought field therapy
16260589|NCT00932919|Behavioral|Cognitive therapy|12 sessions of Cognitive therapy
16260590|NCT00932919|Behavioral|Wait list|3 months waiting, then randomized to either thought field therapy or cognitive therapy
16260591|NCT00932906|Other|Different self-training methods|Self training with MiniAnne Training Kit
16260592|NCT00932906|Other|Standard training|Instructor-based training meeting ERC directions
16260593|NCT00932893|Drug|PF-02341066|PF-02341066, 250 mg BID will be administered orally on a continuous schedule
16260594|NCT00932893|Drug|Pemetrexed|Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
16260595|NCT00932893|Drug|Docetaxel|Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
16260596|NCT00932880|Drug|Amlodipine Besylate|10 mg tablets (Torrent Pharmaceuticals, India)
16260597|NCT00932880|Drug|Norvasc|10 mg dose (Pfizer, USA)
16260598|NCT00932867|Drug|Kinzal/Pritor (Telmisartan, BAY68-9291)|Patients under daily life treatment receiving Pritor according to local drug information.
16260599|NCT00932854|Procedure|EBUS|Endobronchial ultrasound guided transbronchial needle aspiration will be performed under conscious sedation and as an outpatient procedure. Additional bronchoscopy, transbronchial biopsies and bronchoalveolar lavage will be performed at the investigator's discretion.
16260600|NCT00932841|Other|Placebo|One packet PO daily x 8 weeks.
16260601|NCT00932841|Drug|VSL#3 900 billion bacteria|One packet PO daily, x 8 weeks
16260602|NCT00932841|Drug|VSL#3 90 billion bacteria|One packet PO daily, x 8 weeks.
16260603|NCT00932828|Drug|Peanut oral immunotherapy|Defatted peanut in flour form to be used as treatment for peanut allergy
16260604|NCT00932802|Drug|Moxifloxacin (Avelox, BAY12-8039)|AECB patients under daily life treatment receiving moxifloxacin according to the local product information.
16260605|NCT00932776|Device|TBA care device|Tracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first.
16260606|NCT00932776|Device|Control|In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.
16260607|NCT00932763|Drug|Amlodipine besylate|10 mg tablets (Torrent Pharmaceuticals, India)
16260608|NCT00932763|Drug|Norvasc|10 mg dose (Pfizer, USA)
16260609|NCT00932750|Dietary Supplement|Coffee mannooligosaccharide|2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.
16260610|NCT00932750|Dietary Supplement|Coffee mannooligosaccharides|Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo
16260611|NCT00932737|Drug|Placebo|1-5 tablets per episode
16260612|NCT00932737|Drug|Placebo|1-5 tablets per episode
16260613|NCT00932737|Drug|HBB 20 mg|Active drug, one to five tablets per episode
16260614|NCT00932724|Drug|CY-503|Ampoules with 1 ml 350 ng CY-503 solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks
16260615|NCT00932724|Drug|Placebo|Ampoules with 1 ml placebo solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks
16260616|NCT00932711|Behavioral|Educational brochures|A locally developed educational brochure containing information about smoking cessation, influenza and pneumococcal vaccination, regular exercise, compliance with prescribed COPD therapy and recognition of symptoms, along with a goal setting questionnaire
16260617|NCT00932698|Drug|Ixazomib|Ixazomib capsules
16260618|NCT00932685|Drug|Midazolam|Midazolam 0.5mg/kg
16260619|NCT00932685|Device|Game Boy|Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction
16260620|NCT00932672|Behavioral|Atkins Diet|Patients are given an outline of the Atkins diet and are asked to follow it for 6 months
16260621|NCT00932659|Device|continuous cardiac monitoring device (REVEAL, Medtronic)|hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
16260622|NCT00932646|Drug|BI 1744 (Olodaterol) Low Dose|BI1744 Respimat low dose once daily and placebo Foradil
16260623|NCT00932646|Drug|BI 1744 (Olodaterol) Medium Dose|BI1744 Respimat medium dose once daily and placebo Foradil
16260624|NCT00932646|Drug|Placebo|Placebo Respimat once daily and placebo Foradil
16260625|NCT00932646|Drug|Foradil|12 mcg twice daily and placebo Respimat
16260626|NCT00932620|Drug|SIMVASTATIN 40 mg|SIMVASTATIN 40 mg/day for 3 months
16260627|NCT00932620|Drug|SIMVASTATIN/EZETIMIBE 10/10 mg|SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months
16260628|NCT00932607|Drug|sublingual immunotherapy|"Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken.
~Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed.
~Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy)."
16260629|NCT00932594|Procedure|Adjust the TMJ Pressure to Normal Value|Adjust the TMJ Pressure by the Operation Only Once for Each Patient
16260630|NCT00932594|Other|Do not adjust the pressure of TMJ|Do the treatments normally without additional treatment
16260631|NCT00932581|Other|Bradykinesia UPDRS Motor Full Examination|The first group will receive the full motor examination section in its original order.
16260632|NCT00932581|Other|Bradykinesia subscale of UPDRS Motor Examination|The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section.
16260633|NCT00932555|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Patients under daily life treatment receiving Kogenate according to local drug information.
16260634|NCT00932542|Drug|Eutectic mixture|The eutectic mixture of lidocaine + prilocaine + bupivacaine.
16260635|NCT00932542|Drug|placebo|placebo
16260636|NCT00932542|Drug|lidocaine 2,5%; prilocaine 2,5%|lidocaine 2,5%; prilocaine 2,5%
16260637|NCT00932529|Drug|Olanzapine|Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
16260638|NCT00932529|Drug|Quetiapine|Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
16260639|NCT00932529|Drug|Risperidone|Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
16260640|NCT00932529|Drug|Ziprasidone|Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
16260641|NCT00932516|Behavioral|South Beach Diet™ with South Beach Diet™ Products|
16260642|NCT00932516|Behavioral|South Beach Diet™|
16260643|NCT00932516|Behavioral|Calorie restricted diet with South Beach Diet™ Products|
16260644|NCT00932516|Behavioral|Calorie Restricted Diet|
16260645|NCT00932503|Device|Vicryl plus|triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
16260646|NCT00932490|Behavioral|Nurse Coaching|Tailored adherence intervention that will be based on the particular needs of patients and advanced practice nurses will suggest individualized strategies to overcome barriers to adherence
16260647|NCT00932477|Drug|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear|1 to 2 drops into each eye three times per day
16260648|NCT00932477|Drug|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear|1 to 2 drops into each eye three times per day
16260649|NCT00932477|Drug|Glycerin and Polysorbate 80 based artificial tear|1 to 2 drops into each eye three times per day
16260650|NCT00932464|Drug|Neratinib|240-mg oral tablet; single dose under fasted conditions
16260651|NCT00932464|Drug|Neratinib|240-mg oral tablet; single dose with high-fat breakfast
16260652|NCT00932451|Drug|PF-02341066|PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
16260653|NCT00932438|Device|LC beads loaded with Irinotecan|Chemoembolization using LC beads loaded with 100mg Irinotecan
16260654|NCT00932438|Drug|Oxaliplatin|Oxaliplatin 85 mg/sqm, IV infusion every two weeks
16260655|NCT00932438|Drug|Leucovorin|Leucovorin 200 mg/sqm, IV infusion every two weeks
16260656|NCT00932438|Drug|5-Fluorouracil|5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week
16260657|NCT00932438|Drug|Bevacizumab|Bevacizumab 5 mg/kg given at the discretion of the treating physician
16260658|NCT00932425|Device|Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)|Patients will be assigned to wear the telemetry device for 21 days
16260659|NCT00932412|Drug|CLARA|Clofarabine 30 mg/m2/day IV (2h) on days 2 to 6 (administered as a 2h infusion in 250 ml of 0.9% normal saline solution) Cytarabine 1 g/m2/day intravenous (2h) 4 hours later on days 1 to 5 (administered as a 2h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 6 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)
16260660|NCT00932412|Drug|HDAc|Cytarabine 3 g/m2/12h intravenous (3h) on days 1, 3, 5 (administered as a 3h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 5 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)
16260661|NCT00932386|Drug|Dexmedetomidine Hcl infusion|0.5mcg/kg/hr
16260662|NCT00932386|Drug|normal saline|0.9% normal saline infusing
16260663|NCT00932373|Drug|trastuzumab-MCC-DM1|Intravenous escalating dose
16260664|NCT00932360|Device|TENS|Active TENS, Placebo TENS and No Treatment TENS
16260665|NCT00932347|Drug|Camellia sinensis mouthwash|mouthrinsing, 2 times/day, for 28 days
16260666|NCT00932347|Drug|Placebo mouthwash|mouthrinsing, 2 times/day, for 28 days
16260667|NCT00932334|Behavioral|TALK PLUS|Participants receive and educational video and booklet about living kidney donation and meet with a social worker
16260668|NCT00932334|Behavioral|TALK Standard|Participants receive and educational video and booklet about living kidney donation
16260669|NCT00932334|Behavioral|Usual Care|Participants receive their usual care
16260670|NCT00932321|Drug|Norethindrone Acetate/Ethinyl Estradiol 24 Days|One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
16260671|NCT00932321|Drug|Norethindrone Acetate /Ethinyl Estradiol 21 Days|One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
16260672|NCT00932308|Dietary Supplement|Western-style diet (WD)|Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database.
16260673|NCT00932308|Dietary Supplement|Prudent Diet (PD)|Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu.
16260674|NCT00932295|Other|OB|10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
16260675|NCT00932295|Other|Sham smoking|10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
16260676|NCT00932295|Other|CROWN SEVEN|"10 puffs from a so-called electronic cigarette named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)"
16260677|NCT00932295|Other|NJOY|"10 puffs from a so-called electronic cigarette named NJOY(16 mg cartridge; 30 second inter puff interval)"
16260678|NCT00932282|Drug|Peanut Oral Immunotherapy|Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.
16260679|NCT00932282|Drug|Omalizumab|Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.
16260680|NCT00932256|Drug|STAHIST NDC #58407-536-01|Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
16260681|NCT00932230|Other|KinesioTape|An elastic tape that will be placed on subject's ankles to determine whether ankle proprioception is improved
16260682|NCT00932217|Drug|filgrastim|subcutaneous filgrastim administration
16260683|NCT00932217|Drug|lenograstim|subcutaneous lenograstim administration
16260684|NCT00932204|Device|repetitive transcranial magnetic stimulation (Magstim rapid magnetic stimulator)|"For the active group, rTMS over the right prefrontal cortex and the SMA was sequentially performed. The rTMS of the right dorsolateral prefrontal cortex was conducted at a point 5 cm anterior to the point at which the MT was determined, and it was administered at an intensity of 110% of the RMT, a frequency of 1 Hz, for 10 minutes, and with an inter-train interval of 2 minutes (1200 stimuli/d).
~The vertex (Cz) was measured for each patient, and the SMA was defined at 15% of the distance between the inion and nasion anterior to Cz on the sagittal midline, according to the international 10-20 EEG system. The rTMS over the SMA was administered at an intensity of 100% of the RMT, a frequency of 1 Hz, for 10 minutes and with an inter-train interval of 2 minutes (1200 stimuli/d).
~For the sham group, the sham stimulation was applied with the coil angled at 45° from the scalp using the same parameters as the active stimulation group over the same area."
16260685|NCT00932191|Procedure|Standard phacoemulsification|Cataract nucleus removal using standard amounts of ultrasound energy
16260686|NCT00932191|Procedure|Reduced ultrasound phacoemulsification|Cataract nucleus removal using less ultrasound energy and more mechanical energy.
16260687|NCT00932178|Behavioral|Calmer Life|Calmer Life is a modified version of an existing Cognitive Behavioral Treatment manual. Participants have the option of including religion and spirituality into coping skills taught as a way of treating anxiety with or without depression in older adults.
16260688|NCT00932165|Drug|Exemestane|"Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows.  The usual adult dose is 25 mg of exemestane administered orally once daily after a meal."
16260689|NCT00932152|Drug|fulvestrant (Faslodex)|Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1.
16260690|NCT00932152|Drug|anastrozole (Arimidex)|Anastrozole (Arimidex) 1 mg orally QD
16260691|NCT00932152|Drug|Bevacizumab (Avastin)|Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
16260692|NCT00932152|Drug|Best supportive care|Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral
16260693|NCT00932139|Procedure|Electro-acupuncture control|First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
16260694|NCT00932139|Procedure|Electro-acupuncture test|First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
16260695|NCT00932126|Drug|PF-03758309|Oral PF-03758309 will be administered in capsules (once or twice daily) until toxicity, progressive disease, or patient refusal to continue on therapy. The starting dose is 1 mg once daily.
16260696|NCT00932113|Drug|Methotrexate|"2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
16260697|NCT00932113|Drug|Adalimumab (Humira)|2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
16260698|NCT00932100|Drug|REG1|IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
16260699|NCT00932100|Drug|Heparin|IV dose per standard of care at the local institution
16260700|NCT00932087|Procedure|Blood sample|Blood sample for lipidomic study
16260701|NCT00932074|Drug|KP-413 Ointment|Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.
16260702|NCT00932061|Other|Traditional Acupuncture|"Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks.
~Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria."
16260703|NCT00932061|Other|Sham Treatment|"Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks.
~Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria."
16260704|NCT00932048|Drug|Atorvastatin|Atorvastatin 10mg once daily for 12 weeks
16260705|NCT00932035|Procedure|axillary lymph node dissection|Undergo reverse mapping-guided axillary lymph node dissection
16260706|NCT00932035|Drug|isosulfan blue based lymphatic mapping|
16260707|NCT00932035|Procedure|axillary lymph node dissection|Undergo standard axillary lymph node dissection
16260708|NCT00932035|Procedure|quality-of-life assessment|Ancillary studies
16260709|NCT00932035|Other|Questionnaire administration|Ancillary studies
16260710|NCT00932022|Drug|Trospium Chloride, Extended Release (XR)|Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.
16260711|NCT00932022|Other|placebo|Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
16260712|NCT00931996|Drug|Antipsychotic|Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.
16260713|NCT00931957|Drug|Etanercept, Methotrexate, Prednisolone|"In: Arm A, Etanercept-MTX-Prednisolone:
~Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.
~In Arm B:
~Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses."
16260714|NCT00931944|Drug|KNS-760704|150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
16260715|NCT00931931|Biological|HSV1716|
16260716|NCT00931918|Drug|Bortezomib|Bortezomib IV
16260717|NCT00931918|Drug|Rituximab|Rituximab IV
16260718|NCT00931918|Drug|Cyclophosphamide|Cyclophosphamide IV
16260719|NCT00931918|Drug|Doxorubicin|Doxorubicin IV solution
16260720|NCT00931918|Drug|Vincristine|Vincristine IV
16260721|NCT00931918|Drug|Prednisone|Prednisone tablet
16260722|NCT00931905|Drug|Homeopathic medication Plumbum metallicum|The homeopathic medication Plumbum metallicum 15CH was used and was diluted and dynamized using the Hahnemann centesimal scale, whose matrix was obtained from the Schraiber laboratory in 4CH in 70% ethanol. From this solution, the matrix was elevated to 14CH in 70% ethanol. The 15CH dynamization was prepared in 30% ethanol, which was the recommended solution for administration.The drugs were administered orally (ten drops) twice daily - at the beginning and the end of the shift and under supervision for 30 days. The patients were instructed not to take other medication without medical guidance during the time they were participating in the research.
16260723|NCT00931905|Other|Hydroalcoholic solution|The placebo was composed of a hydroalcoholic solution also prepared in 30% ethanol. It was administered orally (ten drops) twice daily - at the beginning and the end of the shift and under supervision for 30 days. The patients were instructed not to take other medication without medical guidance during the time they were participating in the research.
16260724|NCT00931892|Dietary Supplement|Gluten|3g
16260725|NCT00931892|Dietary Supplement|Gluten|10g
16260726|NCT00931879|Drug|omega-3-ethyl esters|Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients.
16260727|NCT00931879|Drug|Placebo|Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
16260728|NCT00931866|Drug|Diclofenac Sodium|Topical diclofenac patch applied once daily to area of pain
16260729|NCT00931866|Drug|Matching Placebo Patch|Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
16260730|NCT00931853|Drug|SENNA+CASSIA(Naturetti)|Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
16260731|NCT00931840|Drug|EZN-2208, Cetuximab and Irinotecan|"Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
~Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C)."
16260732|NCT00931827|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Patients under daily life treatment receiving Mirena according to local drug information.
16260733|NCT00931827|Drug|Implanon (Etonogestrel)|Patients under daily life treatment receiving Implanon according to local drug information.
16260734|NCT00931814|Other|exercise training|A progressive and structured, small-group exercise training 3 times a week, 30-40 min a session at intensity of 12-14 in rate of perceived exertion (RPE) for 8 weeks
16260735|NCT00931801|Drug|atazanavir/raltegravir|Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
16260736|NCT00931801|Drug|atazanavir/raltegravir|Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
16260737|NCT00931801|Drug|atazanavir/tenofovir/emtricitabine|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
16260738|NCT00931788|Drug|Antihypertensive agents and lipid lowering therapy|The above agents will be initiated/titrated in accordance to guidelines approved by Canadian Hypertension Education Program and the Canadian Best Practice Recommendations for Stroke Care
16260739|NCT00931788|Other|Usual Care|Monthly education and reinforcement of risk factor modification, and blood pressure measurement.
16260740|NCT00931775|Drug|Pindolol|Pill orally administered. 15 mg/day t.i.d.
16260741|NCT00931762|Drug|Panobinostat|Panobinostat oral capsules
16260742|NCT00931749|Device|Low intensity pulsed ultrasound therapy|1 MHz, Spatial Average Intensity of 0.2 W /cm2, pulsed duty cycle 20%, 9.5 minutes, Therapeutic dose= 112.5 J/cm2. Fixed application on the medial side of the knee joint. Three sessions per week, during 2 months ( 24 sessions)
16260743|NCT00931749|Device|Sham Low intensity pulsed ultrasound therapy|The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.
16260744|NCT00931736|Drug|Isoniazid|The dosage of the medication is determined according to the weight of the subject. The dose is once per day, in pill format, for a total daily dose of 300mg if subject weighs ≥ 42 kg, otherwise 200 mg. Total duration of treatment is for 9 months.
16260745|NCT00931736|Drug|Rifampin|The dosage of the medication is determined according to the weight of the subject. The dose is once per day, in pill format, for a total daily dose of 600 mg if the subject weighs ≥ 50 kg, 450 mg if the subject weighs ≥ 36 kg and < 50 kg, otherwise 300 mg for those weighing < 36 kg. Total duration of treatment is for 4 months.
16260746|NCT00931723|Drug|Quetiapine fumarate XR|Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
16260747|NCT00931723|Drug|Lithium|Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
16260748|NCT00931723|Drug|Placebo|Oral treatment twice daily.
16260749|NCT00931710|Drug|valsartan, amlodipine, HCTZ|combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
16260750|NCT00931710|Drug|Losartan, HCTZ followed by valsartan, amlodipine, HCTZ|losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study
16260751|NCT00931697|Drug|AD 452 (+) mefloquine|Single dose delivered as over-encapsulated tablet at ascending doses
16260752|NCT00931697|Drug|Racemic Mefloquine|Single dose delivered as over-encapsulated tablet at ascending dose
16260753|NCT00931697|Drug|Placebo|Over-encapsulated placebo to maintain blinding
16260754|NCT00931671|Other|Exercise training|aerobic exercise training
16260755|NCT00931645|Procedure|Autologous stem cell transplantation|TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)
16260802|NCT00931281|Drug|ABT-450|capsules, QD or BID, 14 days, ascending doses
16260803|NCT00931281|Drug|ritonavir|capsules, QD or BID, 14 days, ascending doses
16260756|NCT00931645|Procedure|DHAP rescue and Autologous stem cell transplantation|DHAP :IV cisplatin 100 mg/sqm d1, IV cytarabine 2 g/sqm d2,, IV dexamethasone 40 mg/sqm d1-4, TBI (10 grays d-3-1), cyclophosphamide (60 mg/sqm d-5-4)
16260757|NCT00931645|Procedure|DHAP rescue and F+C|DHAP :IV cisplatin 100 mg/sqm d1, IV Cytarabine 2 g/sqm d2, IV dexamethasone 40 mg/sqm d1-4, Followed by 3 monthly cycles with IV d1-3 fludarabine (25 mg/sqm) & cyclophosphamide (300 mg/sqm)
16260758|NCT00931632|Drug|Inhaled Nitric Oxide|Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
16260759|NCT00931632|Drug|Placebo|Nitrogen gas will be administered in the same manner as the experimental drug.
16260760|NCT00931606|Biological|Biological: ACE-011|up to 4 subcutaneous doses of ACE-011 given once every 28 days
16260761|NCT00931606|Drug|Placebo|up to 4 subcutaneous doses of placebo given once every 28 days
16260762|NCT00931593|Device|Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)|"Visit V0 (day 0 - 2 to 14 days):
~Subject selection
~Obtaining of written informed consent
~Visit V1 (day 0):
~Fasting subject
~Randomization to determine the examination order
~Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial)
~Visit V2 (day 0 + 1 day): Phone contact
~Visit V3 (day 0 + 2 to 7 days):
~Same as V1
~Visit V4 (V3 + 1 day): Phone contact and end of the study"
16260763|NCT00931580|Dietary Supplement|Vitamin D3|vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
16260764|NCT00931567|Biological|Autologous platelets gel|"Application of autologous platelets gel (Platelet Rich Fibrin) after the  open palm  surgical treatment of Dupuytren's disease."
16260765|NCT00931567|Device|Vaselitulle|"application of standardized wound dressing after the  open palm  surgical treatment of Dupuytren's disease."
16260766|NCT00931554|Procedure|Postoperative drain removal|removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)
16260767|NCT00931541|Drug|AZD6088|Oral solution. Each subject will receive a single-dose of AZD6088.
16260768|NCT00931541|Drug|Placebo|Oral solution. Each subject will receive a single-dose of placebo.
16260769|NCT00931528|Drug|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
16260770|NCT00931528|Other|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
16260771|NCT00931515|Device|NuBac|NuBac device implanted at the L4/5 level.
16260772|NCT00931515|Device|Prodisc-L|Prodisc-L implanted at the L4/5 level.
16260773|NCT00931489|Drug|ranibizumab (Lucentis(R))|0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
16260774|NCT00931476|Drug|somatropin|
16260775|NCT00931476|Drug|placebo|
16260776|NCT00931463|Drug|raltegravir|400 mg raltegravir tablet taken every 12 hours
16260777|NCT00931463|Drug|2N(t)RTI|2N(t)RTIs as prescribed
16260778|NCT00931463|Drug|Ritonavir-boosted lopinavir|2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours
16260779|NCT00931450|Drug|exemestane|Given orally
16260780|NCT00931450|Drug|sunitinib malate|Given orally
16260781|NCT00931450|Other|placebo|Given orally
16260782|NCT00931437|Dietary Supplement|vitamin K-rich dairy product|several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.
16260783|NCT00931424|Procedure|valve reconstruction|reconstruct valve at the same time of superficial vein surgery
16260784|NCT00931411|Other|Formulation 609580 20|Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
16260785|NCT00931411|Other|Formulation 609209 (Lipikar Baume)|Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
16260786|NCT00931398|Drug|methylphenidate HCl (Concerta)|Concerta 18 mg, 36 mg, 54 mg, and 72 mg q.am.
16260787|NCT00931398|Drug|Placebo|Matched placebo for all Concerta doses.
16260788|NCT00931385|Drug|BI 1744|BI1744 Respimat Med Dose Once Daily
16260789|NCT00931385|Drug|bi1744|1744 low dose
16260790|NCT00931385|Drug|Placebo|Placebo Respimat and Foradil Placebo
16260791|NCT00931385|Drug|Foradil|Foradil 12 mcg twice daily and Placebo Respimat
16260792|NCT00931372|Drug|Lixisenatide (AVE0010)|Solution for subcutaneous injection 100 µg/mL
16260793|NCT00931372|Drug|Placebo|Subcutaneous injection
16260794|NCT00931359|Device|DTS-G2 System|Treatment with microwave energy
16260795|NCT00931359|Device|DTS System (Sham treatment)|Sham treatment - no energy is delivered
16260796|NCT00931346|Drug|FTC/TDF|emtricitabine/tenofovir disoproxil fumarate
16260797|NCT00931346|Drug|Placebo|Placebo
16260798|NCT00931333|Procedure|non percutaneous vertebroplasty|The patient will undergo general anaesthetic. With a low invasive approach, 4 screws will be placed in pedicles of vertebra under and above the fractured vertebra. The reduction of the fracture will be realised by a smooth movement, and screws positions will be verified by a radio control, with a guided navigation system. The stems will be placed and locked. After the screw positioning, the fractured vertebra pedicles will be reached by a low invasive approach, using a 6 mm trocar, to raise, if necessary, the vertebral plate. Then the cement will be injected in the vertebral body, under radio control. When the maximal volume (6 to 8 ml) is reached, or if an extra vertebral leak is detected, the cement injection is stopped. Then the incision is closed. The next day, the patient will be placed in a corset for a 2 months period.
16260799|NCT00931307|Device|Lotrafilcon A contact lens|Silicone hydrogel, spherical, soft contact lens
16260800|NCT00931294|Behavioral|Choir singing|"Choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material To Live with IBS for home studies, weekly for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months."
16260801|NCT00931294|Behavioral|Information Group|Meet in groups, studying and discussing on the same materials under the direction of a group leader, weekly, for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months.
16260804|NCT00931281|Drug|Placebo for ABT-450|capsule, QD or BID, 14 days
16260805|NCT00931281|Drug|Placebo for ritonavir|capsule, QD or BID, 14 days
16260806|NCT00931268|Device|Macrolane VRF 30|One administration
16260807|NCT00931255|Drug|Tacrolimus|3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol
16260808|NCT00931255|Drug|Sirolimus|5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
16260809|NCT00931242|Drug|Apremilast|Apremilast is being evaluated at daily doses of 20 mg by mouth (PO) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type Atopic Dermatitis (AD) or Allergic Contact Ddermatitis (ACD).
16260810|NCT00931229|Drug|entecavir|All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines. The primary endpoint of this study is the incidence of HBV reactivation, defined by a greater than 10-fold increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy and within 1 year after completion of the last course of rituximab-CHOP chemotherapy. Patients who have HBV reactivation during the study period will receive free entecavir treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks.
16260811|NCT00931216|Procedure|Integrated ANC, PMTCT, HIV services|Of the 12 study clinics, 6 will be randomized to receive the intervention. At these 6 facilities, health care providers within the ANC department will be trained to also provide HIV/PMTCT care. Women testing positive within ANC clinics at integrated facilities will receive ANC, PMTCT and HIV services within the same visit/same service provider rather than being referred for HIV care and treatment.
16260812|NCT00931203|Drug|Celecoxib|Celecoxib (400 mg/d) will be continued from day 1 to 65
16260813|NCT00931177|Other|weight|weight and dehydration scores
16260814|NCT00931177|Other|weight and dehydration score|weight and dehydration score
16260815|NCT00931164|Drug|Sodium Oxybate|dosage is by weight
16260816|NCT00931151|Dietary Supplement|Postprandial metabolic and functional measures|After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.
16260817|NCT00931138|Drug|chemotherapy (Aracytine + Daunorubicin)|Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
16260818|NCT00931138|Drug|chemotherapy (Aracytine + Daunorubicin)|Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
16260819|NCT00931138|Drug|chemotherapy (Aracytine + Daunorubicin)|Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
16260820|NCT00931125|Drug|ranibizumab and vitrectomy|ranibizumab 10mg/ml intravitreal injection, 0,05 ml
16260821|NCT00931125|Procedure|vitrectomy without preoperative ranibizumab|sham intravitreal injection before vitrectomy surgery
16260822|NCT00931112|Other|individualized exercise training|Lower extremities resistance exercise and bicycle training
16260823|NCT00931086|Drug|belimumab|IV 10mg/kg q28days
16260824|NCT00931073|Drug|Dimebon alone|Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
16260825|NCT00931073|Drug|Dimebon + Ketoconazole|Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
16260826|NCT00931073|Drug|Dimebon + Omeprazole|Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
16260827|NCT00931060|Dietary Supplement|Branched chain amino acids|Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day
16260828|NCT00931034|Behavioral|South Beach Diet with South Beach Diet Products|
16260829|NCT00931034|Behavioral|American Diabetes Association Diabetes Meal Plan|
16260830|NCT00931021|Drug|Varenicline (Chantix)|2 mg
16260831|NCT00931021|Drug|Nicotine Patch|21 mg
16260832|NCT00931008|Drug|SID530, Taxotere|75mg/m2
16260833|NCT00930995|Drug|Candesartan|16mg po daily
16260834|NCT00930995|Drug|Placebo|once daily
16260835|NCT00930982|Drug|Ciprofloxacin (Cipro, BAYQ3939)|Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
16260836|NCT00930982|Drug|Placebo|Inhalation of matching placebo twice a day
16260837|NCT00930969|Device|ICD|Subjects implanted with an ICD.
16260838|NCT00930956|Dietary Supplement|Resistant Starch|30 g of carbohydrate per Arm
16260839|NCT00930943|Drug|Oxymorphone ER (Opana ER)|40 mg qd twice
16260840|NCT00930930|Drug|cisplatin|Given IV
16260841|NCT00930930|Drug|everolimus|Given orally
16260842|NCT00930930|Drug|paclitaxel|Given IV
16260843|NCT00930930|Other|placebo|Given orally
16260844|NCT00930930|Procedure|Venous blood draw|Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
16260845|NCT00930917|Device|Polyethylene cap|In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
16260846|NCT00930917|Device|Polyethylene wrap|Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
16260847|NCT00930917|Other|conventional treatment|Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
16260848|NCT00930891|Drug|Standard Chemotherapy (PCDE or PE)|"PCDE: cisPlatin 75 mg/m² D2 ; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles
~PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles"
16260849|NCT00930891|Drug|Experimental Treatment (PCDE or PE + bevacizumab)|"PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression
~PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression"
16260938|NCT00930189|Drug|intravitreal injection of ranibizumab|
16260939|NCT00930189|Drug|intravitreal injection of triamcinolone|
16260940|NCT00930189|Procedure|photodynamic therapy|
16260850|NCT00930891|Drug|Prerandomization Chemotherapy (PCDE or PE)|"PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 2 cycles
~PE: cisplatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 2 cycles"
16260851|NCT00930878|Device|Cardiac Stenting|Drug Eluting stent
16260852|NCT00930865|Drug|Bumetanide|Tablets, Oral, 1 mg, Single Dose, 7 Days
16260853|NCT00930865|Drug|Dapagliflozin|Tablets, Oral, 10 mg. Single Dose, 7 Days
16260854|NCT00930839|Drug|Niacin and aspirin|1000 mg Niacin, 325 mg aspirin
16260855|NCT00930813|Device|Lutonix Catheter|Paclitaxel Coated Balloon Catheter
16260856|NCT00930813|Device|Standard uncoated Balloon Angioplasty Catheter|plain, uncoated angioplasty balloon catheter
16260857|NCT00930800|Other|Exercise|Using a video game so-called Dance Dance Revolution (DDR)
16260858|NCT00930787|Device|Strattice Reconstructive Tissue Matrix (Hernia Repair)|Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
16260859|NCT00930787|Device|Proceed Surgical Mesh (Hernia repair)|Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
16260860|NCT00930774|Device|FM system|Frequency modulation assistive device
16260861|NCT00930774|Behavioral|Auditory training|Participation in computerized auditory training program for eight weeks
16260862|NCT00930761|Behavioral|Music therapy|Music therapy sessions systematically offered to all mothers in the intervention group, three times a week, not mandatory, conducted by two music therapists in an appropriate room, during 60 minutes.
16260863|NCT00930748|Device|MR imaging with endorectal coil|MR imaging with endorectal coil
16260864|NCT00930748|Device|MRI with endo-rectal coil|MRI with endo-rectal coil
16260865|NCT00930722|Drug|quinapril|per label as non interventional study
16260866|NCT00930709|Drug|Botulinum toxin type A (Botox®, Allergan)|Two injections of 10-60 units of botulinum toxin type A. Injections are administered with ENMG assisted technique at the baseline and after 13 weeks.
16260867|NCT00930709|Behavioral|Active strength training and stretching|Training duration 9 weeks, intensified every 3 weeks in supervision of physiotherapist. Training program includes progressive, slow, repetitive wrist and forearm stretching, eccentric muscle strengthening, occupational exercises and upper limb neural mobilization training.
16260868|NCT00930696|Procedure|Extensive abdominal lavage|Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
16260869|NCT00930696|Procedure|Rinsing of the abdomen|Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure
16260870|NCT00930683|Drug|MEDI-546|0.1 mg/kg MEDI-546 as a single IV dose
16260871|NCT00930683|Drug|MEDI-546|0.3 mg/kg MEDI-546 as a single IV dose
16260872|NCT00930683|Drug|MEDI-546|1.0 mg/kg MEDI-546 as a single IV dose
16260873|NCT00930683|Drug|MEDI-546|3.0 mg/kg MEDI-546 as a single IV dose
16260874|NCT00930683|Drug|MEDI-546|10.0 mg/kg MEDI-546 as a single IV dose
16260875|NCT00930683|Drug|MEDI-546|0.3 mg/kg MEDI-546 as a weekly IV dose x 4 doses
16260876|NCT00930683|Drug|MEDI-546|1.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
16260877|NCT00930683|Drug|MEDI-546|5.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
16260878|NCT00930683|Drug|MEDI-546|20.0 mg/kg MEDI-546 as a single IV dose
16260879|NCT00930670|Drug|Rosuvastatin-omeprazole|Rosuvastatin 20 mg for 1 month. Then rosuvastatin 20mg and omeprazole 20mg for 11 months
16260880|NCT00930670|Drug|Rosuvastatin-pantoprazole|Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months
16260881|NCT00930670|Drug|Rosuvastatin-esomeprazole|Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months
16260882|NCT00930670|Drug|Rosuvastatin-ranitidine|Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300mg for 11 months
16260883|NCT00930670|Drug|Atorvastatin-omeprazole|Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months
16260884|NCT00930670|Drug|Atorvastatin-pantoprazole|Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40 mg for 11 months
16260885|NCT00930670|Drug|Atorvastatin-esomeprazole|Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months
16260886|NCT00930670|Drug|Atorvastatin-ranitidine|Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months
16260887|NCT00930644|Drug|teduglutide|0.05 mg/kg/day subcutaneously taken once per day for 24 months
16260888|NCT00930631|Drug|[3H] BMS747158|Single bolus intravenous injection of [3H] BMS747158
16260889|NCT00930618|Drug|IMN|Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
16260890|NCT00930618|Drug|Placebo|Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration
16260891|NCT00930605|Drug|CHOP regimen alternate with ESHAP regimen|CHOP alternate with ESHAP is given every 21 days for a total of 6 course.
16260892|NCT00930605|Drug|Alemtuzumab|Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.
16260893|NCT00930579|Drug|Metformin|1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
16260894|NCT00930566|Drug|methoxsalen|"UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®.
~In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula :
~Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag.
~After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient."
16260895|NCT00930566|Procedure|Extracoporal Photopheresis (ECP)|"In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button.
~After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient."
16260896|NCT00930553|Biological|alemtuzumab|Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.
16260897|NCT00930527|Dietary Supplement|Omega-3 Fatty Acid|4g per day for 3 weeks
16260898|NCT00930514|Drug|Rituximab|Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
16260899|NCT00930514|Drug|Rituximab|Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
16260900|NCT00930514|Drug|Rituximab|Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
16260901|NCT00930514|Drug|Rituximab|Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
16260902|NCT00930514|Drug|Rituximab|Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.
16260903|NCT00930501|Biological|blood tests|time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy
16260904|NCT00930488|Drug|Avelox (Moxifloxacin, BAY12-8039)|Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin
16260905|NCT00930475|Drug|RAD001 (Everolimus) in combination with carboplatin|phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress
16260906|NCT00930475|Drug|RAD001 (Everolimus) in combination with carboplatin|phase 2: 10mg RAD001 in combination with carboplatin
16260907|NCT00930462|Device|Cap (Olympus Medical Systems: D-201-15004, D-201-14304 and D-201-12704)|Plastic cap fitted on the colonoscope
16260908|NCT00930449|Other|Cogmed Working Memory Training Program.|"This program includes a set of visual-spatial and auditory-verbal WM tasks presented via the computer (see Appendix 1 for a description of these tasks). All tasks involve: a) maintenance of simultaneous mental representations of multiple stimuli; b) unique sequencing of stimulus order in each trial; and c) progressive adaptation of difficulty level as a function of individual performance.
~Training will require about 30 minutes per day, 5 days per week, for 5-6 weeks: participants are required to complete 90 WM trials on each training day. Training plans are individualized and are modified according to performance, but the typical plan includes 13 tasks, with 15 trials of 8 tasks each day."
16260909|NCT00930449|Other|Academy of Math|"This is an established evidence-based program designed to help at-risk learners (Grades K-12) develop mathematical proficiency by incorporating a mastery-learning approach to foster conceptual understanding, computational fluency, and strategic competency across 10 mathematical subject areas.
~Training is will require about 30 minutes, 5 days per week, for the same duration as the WM program (5-6 weeks), with a counselor or teacher acting as the training aide."
16260910|NCT00930449|Other|Special Education/Individualized Tutoring|Students in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need.
16260911|NCT00930436|Drug|sodium bicarbonate|Serum creatinine will be measured on Days 3,7, 30, 90, and 180
16260912|NCT00930410|Procedure|Endoscopic Retrograde Cholangio-Pancreatography (ERCP)|Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
16260913|NCT00930371|Other|high fat/high saturated fat diet|4 weeks 55% fat/25% saturated fat isocaloric diet
16260914|NCT00930371|Other|low fat/low saturated fat diet|4 weeks 20% fat/8% saturated fat isocaloric diet
16260915|NCT00930358|Drug|MEOPA|anaesthetic gaz inhalation
16260916|NCT00930358|Drug|general anaesthesia|Anaesthetic intravenous route
16260917|NCT00930345|Drug|Sunitinib (SUTENT)|"Sunitinib, SUTENT, 50 mg daily p.o., on schedule 4/2, for 2 cycles. Two weeks of rest prior to surgery (week 11 and 12).
~Radical nephrectomy at the end of week 12. Sunitinib 50 mg/d, schedule 4/2, reintroduced 2 weeks after surgery (week 14, may be postponed by one or two weeks if wound healing delay or surgical complications). Treatment until disease progression, unacceptable toxicity or consent withdrawal. Dose reduction depending on the type and severity of toxicity.
~At the end of the treatment period patients will be treated at the discretion of the Investigator."
16260918|NCT00930332|Drug|methadone hydrochloride|"Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
~Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
~Level 3: 3mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
~OR
~Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
~Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
~Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)"
16260919|NCT00930332|Other|questionnaire administration|within 48 hours of registration
16260920|NCT00930332|Procedure|management of therapy complications|if required
16260921|NCT00930319|Other|Firmagon given by prescription according to SPC|Non-interventional,observational Firmagon given by prescription according to SPC
16260922|NCT00930306|Drug|AZD2066|12 doses, Given as capsule, 2 mg & 8 mg
16260923|NCT00930306|Drug|Caffeine|2 doses, Given as Tablet, 2x50 mg
16260924|NCT00930306|Drug|Tolbutamide|2 doses, Given as Tablet, half of 500 mg
16260925|NCT00930306|Drug|Omeprazole Tablet, 20 mg|2 doses, Given as Tablet, 20 mg
16260926|NCT00930306|Drug|Midazolam Tablet, 7.5 mg|2 doses, Given as Tablet, 7.5 mg
16260927|NCT00930293|Behavioral|Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS)|16 weekly IPT-PS sessions, each lasting approximately 45 minutes
16260928|NCT00930293|Behavioral|Brief Supportive Psychotherapy (BSP)|16 weekly BPS sessions, each lasting approximately 45 minutes
16260929|NCT00930293|Drug|Citalopram hydrobromide|A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
16260930|NCT00930254|Procedure|IV puncture guided by ultrasound|Comparisons between traditional and ultrasound group
16260931|NCT00930241|Drug|Advagraf®|Advagraf® (one daily dose of Tacrolimus)
16260932|NCT00930241|Drug|Prograf®|Prograf® (two daily doses of Tacrolimus)
16260933|NCT00930228|Drug|Flutamide|Flutamide, 250 mg capsule for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)
16260934|NCT00930228|Drug|Placebo|Placebo, for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)
16260935|NCT00930215|Drug|D961H|Oral gelatin capsule
16260936|NCT00930215|Drug|D961H|Oral HPMC capsule
16260937|NCT00930202|Drug|Conivaptan (Vaprisol)|Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.
16260941|NCT00930176|Biological|Human Coagulation FACTOR X|Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
16260942|NCT00930163|Drug|lebrikizumab (MILR1444A)|Subcutaneous repeating dose
16260943|NCT00930163|Drug|placebo|Subcutaneous repeating dose
16260944|NCT00930150|Behavioral|Targeted cognitive training|Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
16260945|NCT00930150|Behavioral|Computer control|Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
16260946|NCT00930150|Behavioral|Bridging groups|Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
16260947|NCT00930150|Behavioral|Health and wellness groups|Weekly group meetings that teach participants health and wellness skills
16260948|NCT00930137|Other|isocaloric for week diet|"Consumption of the 2 experimental diets
~a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);
~a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal)."
16260949|NCT00930124|Procedure|Orthognathic surgery|Patients with moderate maxillary hypoplasia needing an advancement of 4-10mm
16260950|NCT00930124|Procedure|Distraction osteogenesis|
16260951|NCT00930111|Other|2-week rotation|Attending physician is assigned to a 2-week rotation.
16260952|NCT00930111|Other|4-week rotation|Attending physician is assigned to a 4-week rotation.
16260953|NCT00930098|Drug|clofarabine|
16260954|NCT00930085|Other|SELDI-TOF MS for plasmatic proteic profile|An extra blood sample is required to determine the plasmatic proteic profile used to identify one or several signatures which are correlated to the clinical evolution (mortality at D30).
16260955|NCT00930072|Drug|Cervical Sympathetic Block (bupivicaine, clonidine)|12-15ml solution of bupivicaine .5% containing 50 mcg of clonidine for cervical sympathetic block administered in a single injection.
16260956|NCT00930059|Drug|PF-04447943|tablets, 25 mg every 12 hours for 12 wks
16260957|NCT00930059|Drug|Placebo|matching placebo tablets, every 12 hours for 12 wks
16260958|NCT00930046|Device|Ropivacaine wound catheter|19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
16260959|NCT00930046|Device|Saline wound catheter|19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
16260960|NCT00930033|Procedure|Nephrectomy|Current surgery
16260961|NCT00930033|Other|Sunitinib alone|Sunitinib alone without nephrectomy
16260962|NCT00930020|Drug|Minocycline (Borymycin)|oral dose, 200 mg once a day for 5 days
16260963|NCT00930020|Drug|Matched placebo|matched placebo (cornstarch) once a day for 5 days
16260964|NCT00930007|Other|Blood sampling|Blood sampling for later hormone measurements
16260965|NCT00929994|Behavioral|Cardiac Rehabilitation|Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
16260966|NCT00929981|Drug|Tablet Methylprednisolone (4 or 16 mg)|Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information
16260967|NCT00929968|Biological|Placebo|
16260968|NCT00929968|Biological|VAK694|
16260969|NCT00929968|Drug|Fluticasone|
16260970|NCT00929955|Drug|Ondansetron|ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
16260971|NCT00929955|Drug|Simvastatin|Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
16260972|NCT00929955|Drug|Placebo|Placebo added to TAU
16260973|NCT00929942|Device|SX-ELLA Stent Degradable DV Bronchial (DV Stent)|"Intervention SX-ELLA Stent Degradable DV Bronchial (DV Stent) will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway complications will be measured by bronchoscopy and documented."
16260974|NCT00929929|Dietary Supplement|L-leucine.|10 g of leucine per day, during 12 weeks.
16260975|NCT00929929|Dietary Supplement|Maltodextrin.|10 g of maltodextrin per day, during 12 weeks.
16260976|NCT00929929|Behavioral|Exercise program.|Progressive resistance exercise program 4 days a week, during 12 weeks.
16260977|NCT00929903|Drug|pazopanib hydrochloride|Given orally
16260978|NCT00929903|Other|pharmacological study|Correlative studies
16260979|NCT00929890|Behavioral|General lifestyle, diet and physical activity counselling|Low-calorie, balanced diet and a general advice on the importance of regular physical activity
16260980|NCT00929890|Behavioral|Exercise training|Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program
16260981|NCT00929877|Drug|KETOPROFEN(RP19583)|Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
16260982|NCT00929877|Drug|KETOPROFEN(RP19583)|Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
16260983|NCT00929877|Drug|Placebo|Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
16260984|NCT00929864|Drug|Abatacept|Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
16260985|NCT00929864|Drug|Adalimumab|Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
16260988|NCT00929838|Behavioral|Diabetes Knowledge/Information|This group will receive telephone-delivered diabetes knowledge/information lasting 30 minutes for 12 weeks.
16260989|NCT00929838|Behavioral|Motivation/Behavioral Skills|This intervention consists of patient activation, patient empowerment, and behavioral skills training delivered via telephone lasting 30 minutes every week for 12 weeks.
16260990|NCT00929838|Behavioral|Combined Intervention|This group will receive all components of the diabetes knowledge/information and the motivation/behavioral skills interventions via telephone lasting 30 minutes every week for 12 weeks.
16261126|NCT00928889|Drug|Acarbose 50 mg|Acarbose 50 mg was supplied as tablets.
16260991|NCT00929838|Behavioral|Usual Care|This group will receive telephone-delivered general health education lasting 30 minutes for 12 weeks to control for attention and content.
16260992|NCT00929825|Device|mechanical stimulation (Elastomers)|The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals
16260993|NCT00929825|Procedure|TENS|transcutaneous electrical stimulation
16260994|NCT00929812|Drug|Glucagon hydrochloride (GlucaGen®)|1 mg/1 ml of glucagon hydrochloride intramuscularly
16260995|NCT00929812|Drug|NaCl 0.9%|1 ml NaCl 0.9% intramuscularly
16260996|NCT00929799|Drug|recombinant human Growth Hormone (Genotropin® )|Once daily by subcutaneous injection using a Genotropin pen in the abdomen at 22:00 h. Maximal GH dose of 0.003 mg/kg/day.
16260997|NCT00929773|Device|Erchonia PL2000 Laser|Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
16260998|NCT00929773|Device|Placebo laser|Inactive laser light.
16260999|NCT00929760|Behavioral|specialised renal care|"Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management.
~Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG."
16261000|NCT00929747|Device|Toric|Unilateral implantation of the AcrySof IQ Toric IOL
16261001|NCT00929747|Procedure|Limbal Relaxing Incision|Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery
16261002|NCT00929734|Drug|Rosuvastatin|10mg tablets, once daily in three months
16261003|NCT00929734|Drug|Placebo|1 tablet, once daily in three months
16261004|NCT00929721|Procedure|Blood draw|culture for Streptococcus pneumoniae Frequency-1
16261005|NCT00929721|Procedure|Chest X-ray|image of the lungs to assess changes consistent with pneumonia Frequency-1
16261006|NCT00929721|Procedure|urine specimen|assay for the presence of Streptococcus pneumoniae Binax and UAD
16261007|NCT00929721|Procedure|Nasopharyngeal swab|culture for Streptococcus pneumoniae Frequency-1
16261008|NCT00929721|Procedure|sputum|culture for Streptococcus pneumoniae Frequency-1
16261009|NCT00929708|Drug|AZD3199|Dry powder for inhalation, o.d., 4 weeks
16261010|NCT00929708|Drug|formoterol|Dry powder for inhalation, b.i.d., 4 weeks
16261011|NCT00929708|Drug|Placebo|Dry powder for inhalation, b.i.d., 4 weeks
16261012|NCT00929695|Drug|prednisone|immunosuppressive drug
16261013|NCT00929695|Drug|methylprednisolone|immunosuppressive drug
16261014|NCT00929695|Other|questionnaire administration|Ancillary studies
16261015|NCT00929682|Drug|Randomization between two referenced treatments|"Levobupivacaine 0.568 mg.mL-1 and sufentanil 0.45 g.mL-1, 20 mL epidurally for induction, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1.
~Same protocol, with levobupivacaine 1.136 mg.mL-1 and sufentanil 0.45 g.mL-1."
16261016|NCT00929669|Drug|pasireotide LAR|pasireotide LAR 80 mg IM once a month
16261017|NCT00929656|Procedure|Real rTMS|rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
16261018|NCT00929656|Procedure|Sham rTMS|sham rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
16261019|NCT00929656|Procedure|Unimanual paretic UE Training|UE exercise for 4 hours (two hours 1:1 with therapist and two hours independent at home) for 16 sessions (4 sessions/week for 4 weeks)
16261020|NCT00929643|Other|no intervention|success of the initial empiric treatment
16261021|NCT00929630|Procedure|transsphincteric Seton positioning|A cutting seton is applied into the fistula tract
16261022|NCT00929630|Procedure|glue (Tissucol) treatment|After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
16261023|NCT00929630|Procedure|Fistula closing with biological glue|After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it
16261024|NCT00929630|Procedure|Seton positioning into the fistula tract|Under spinal anesthesia a Seton is positioned into the fistula tract.
16261027|NCT00929604|Other|HIV-1 viral load testing|Plasma HIV-1 RNA viral load testing performed at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30, and 36 months thereafter. Routine viral load results are provided to clinicians for the management of the participant's HIV treatment.
16261028|NCT00929591|Drug|cyclophosphamide|
16261029|NCT00929591|Drug|doxorubicin hydrochloride|
16261030|NCT00929591|Drug|endocrine therapy|
16261031|NCT00929591|Drug|endocrine-modulating drug therapy|
16261032|NCT00929591|Drug|fluorouracil|
16261033|NCT00929591|Drug|tamoxifen citrate|
16261034|NCT00929591|Radiation|brachytherapy|
16261035|NCT00929591|Radiation|low-LET electron therapy|
16261036|NCT00929591|Radiation|low-LET photon therapy|
16261037|NCT00929591|Radiation|radiation therapy|
16261038|NCT00929578|Drug|Fluphenazine|Intralesional injection of Fluphenazine
16261039|NCT00929578|Drug|Placebo|Intralesional injection of placebo
16261040|NCT00929552|Dietary Supplement|Dietary oils (fish, vegetable oil)|6g pr day.
16261041|NCT00929539|Drug|JTT-130|Tablets
16261042|NCT00929539|Drug|JTT-130 Placebo|Tablets
16261043|NCT00929526|Procedure|Liquid-based cytology (LBC) sampling|LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
16261044|NCT00929526|Procedure|Blood sampling|Blood samples will be collected at Months 36 and 48 for antibody determination
16261045|NCT00929500|Behavioral|MAST program|MAST program: twice a week for 4 months
16261127|NCT00928876|Drug|Anakinra (Kineret)|anakinra 150 mg s/c. daily for four weeks
16261128|NCT00928876|Drug|Placebo|placebo s/c daily for four weeks
16261046|NCT00929487|Device|Contact lens multi-purpose solution|Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
16261047|NCT00929487|Other|Saline/blister pack solution|A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
16261048|NCT00929487|Device|Contact lenses|CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
16261049|NCT00929474|Device|QuickOpt - SJM CRT (Group 1)|The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed AV and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
16261050|NCT00929474|Device|Control - SJM CRT (Group 2)|The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
16261051|NCT00929461|Drug|Lipovenoes® 10% and Omegaven®,|All patients received TPN for 5 days postoperatively, according to a standard protocol: 3 g/kg BW glucose (5% Dextrose in Ringer's Lactate, Biosel, Istanbul), 1.2 g/kg BW amino acids (Aminosteril 10%, Fresenius-Kabi) and 0.8 g/kg BW omega-6 fatty acids (Lipovenoes® 10%, Fresenius-Kabi) were provided to both groups through an indwelling central venous catheter. In the omega-3 group, the lipid content of TPN was replaced partially by omega-3 fatty acids (Omegaven®, Fresenius-Kabi) up to 0.2 g/kg BW per day.
16261052|NCT00929409|Drug|Ferric carboxymaltose|Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
16261053|NCT00929409|Drug|Ferrous sulfate tablets|Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
16261054|NCT00929396|Biological|50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)|o,5 mL suspension for injection x 2 with 2 months interval
16261055|NCT00929396|Biological|50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)|o,5 mL suspension for injection x 2 with 2 months interval
16261056|NCT00929383|Device|Wingspan Stent System with Gateway PTA Balloon Catheter|"The Wingspan Stent System is used in conjunction with Gateway PTA Balloon Catheter to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease.
~The Gateway Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting the artery for the purpose of improving intracranial perfusion."
16261057|NCT00929370|Drug|Glycine Transporter-1 inhibitor|GSK1018921 is a potent and selective inhibitor of the glycine transporter-1 (GlyT-1).
16261058|NCT00929357|Drug|DMARDs or Biologics|
16261059|NCT00929344|Drug|Pregabalin|Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
16261060|NCT00929344|Drug|Duloxetine|40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
16261061|NCT00929344|Behavioral|Standardized behavioral therapy|Standardized behavioral therapy 1 time per week for 12 week duration.
16261062|NCT00929344|Behavioral|Standardized behavioral therapy|Standardized behavioral therapy 1 time per week for 12 week duration.
16261063|NCT00929344|Drug|Placebo|Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
16261064|NCT00929344|Behavioral|Standardized behavioral therapy|Standardized behavioral therapy 1 time per week for 12 week duration.
16261065|NCT00929331|Biological|Fluviral®|Intramuscular injection, one dose
16261066|NCT00929318|Procedure|blood sampling|
16261067|NCT00929318|Procedure|blood sampling|
16261068|NCT00929305|Device|Erchonia PL2000|The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
16261069|NCT00929305|Device|Placebo laser|Inactive laser light
16261070|NCT00929292|Other|Modilac Dahlia 1|Infant formula used for non breastfed children with colic
16261071|NCT00929292|Other|Modilac 1|Infant formula used for non breastfed children
16261072|NCT00929279|Drug|bolus+infusion|Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen
16261073|NCT00929279|Drug|abciximab bolus only regimen|Abciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose
16261074|NCT00929266|Biological|intravenous injection of labeled cRBC|This step will take place within 2 months after stem cell collection. Direct intravenous injection of labeled cRBC in a volume of 1 mL, in a room reserved for the administration of radioactive drugs, situated in the nuclear medicine clinic and adjacent to the preparation laboratory, for regulatory reasons.
16261075|NCT00929253|Drug|Suboxone|Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks
16261076|NCT00929253|Behavioral|CRA|Computer-delivered Community Reinforcement Approach
16261077|NCT00929253|Behavioral|Therapy|Therapist-delivered therapy
16261078|NCT00929253|Behavioral|CM|Contingency management (vouchers) for providing a drug negative urine sample.
16261079|NCT00929240|Drug|bevacizumab [Avastin]|15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
16261080|NCT00929240|Drug|capecitabine [Xeloda]|1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)
16261129|NCT00928863|Other|implementation aids|testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals
16261259|NCT00928083|Drug|OZ439 200mg API capsules|
16261081|NCT00929214|Drug|Standard Therapy|"Chemotherapy and/or Endocrine Therapy:
~For 3 - 9 months, all patients will receive systemic chemotherapy agents appropriate for the tumor characteristics and patient's prior treatment history, and may also be placed on endocrine therapy as determined by the treating medical oncologist."
16261082|NCT00929214|Procedure|Local Therapy|"Surgery and/or Radiation Therapy
~With no more than 3 bone metastases, local treatments including high-dose radiation therapy and/or surgery will be given. Radiation therapy involves daily treatments during weekdays that may last 5 to 7 weeks in a row. Each daily treatment may last 30 - 40 minutes. Surgery, including recovery, may last 4 to 6 weeks."
16261083|NCT00929201|Drug|Sitagliptin phosphate/metformin hydrochloride FDC|Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
16261084|NCT00929201|Drug|Sitagliptin phosphate|Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
16261085|NCT00929201|Drug|Metformin hydrochloride|Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
16261086|NCT00929188|Drug|JNJ-42160443|Type=1, unit=mg, number=10, form=solution for injection , route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks
16261087|NCT00929188|Drug|Placebo|Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
16261088|NCT00929175|Device|active CPAP|auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
16261089|NCT00929175|Device|sham-CPAP|The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.
16261090|NCT00929162|Drug|ZD4054 Zibotentan|10 mg oral tablets once daily
16261091|NCT00929162|Drug|Paclitaxel|175mg/m2 IV on day 1 every 3 weeks
16261092|NCT00929162|Drug|Carboplatin|Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
16261093|NCT00929162|Drug|Placebo|matching placebo for ZD4054 10 mg
16261094|NCT00929136|Biological|USP endotoxin|Continuous intra-arterial infusion
16261095|NCT00929123|Procedure|neural mobilization|manual therapy technique known to directly stress the median nerve
16261096|NCT00929123|Procedure|sham neural mobilization|sham technique mimicking the neural mobilization which is not specific to the median nerve
16261097|NCT00929123|Other|healthy controls|People without carpal tunnel syndrome for comparison
16261098|NCT00929110|Drug|Glycopyrronium bromide|Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16261099|NCT00929110|Drug|Placebo to glycopyrronium bromide|Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16261100|NCT00929110|Drug|Tiotropium|Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
16261101|NCT00929097|Other|Implementation aids|"Patients and clinicians have access to a website with information on familial colorectal cancer risk; a risk assessment tool and decision aids
~Clinicians receive the guidelines and a risk communication tool, as well as education"
16261102|NCT00929097|Other|Control|Dissemination of guidelines
16261103|NCT00929084|Other|The Survivor Stories Tablet|The Survivor Stories Tablet is a tablet computer where participants can browse an archive of 1-3 minute videotaped survivor stories told by African American Breast Cancer Survivors. Stories contain five main topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer.
16261104|NCT00929071|Device|Evolence|Injectable collagen
16261105|NCT00929071|Device|Lidocaine|admix anesthetic
16261106|NCT00929071|Drug|topical anesthetic|
16261107|NCT00929058|Drug|Bevacizumab|Intra-arterial infusion during 6 minutes
16261108|NCT00929045|Drug|Growth Hormone Replacement|
16261109|NCT00929032|Radiation|Nanocoll®|To determine reticuloendothelial system (RES) phagocytosis activity and liver phagocytic function respectively we will measure plasma clearance of 99mTc labelled micro-aggregated human albumin without any imaging studies.
16261110|NCT00929019|Biological|autologous dendritic cells electroporated with mRNA|Autologous mature monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase are vaccinated intradermal/intravenously 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations.
16261111|NCT00929006|Drug|Micronized progesterone suspension|Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
16261112|NCT00929006|Drug|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
16261113|NCT00928980|Behavioral|Mindfulness Based Cognitive Therapy|Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
16261114|NCT00928980|Drug|Optimal Medical Care|Therapeutic dose of antidepressant medication
16261115|NCT00928967|Drug|Interferon beta-1b, (Betaseron BAY86-5046)|The cohort included is described in section 8.5 (inclusion criteria)
16261116|NCT00928954|Drug|gabapentin|increasing to 1200 mg/day
16261117|NCT00928954|Drug|memantine|increasing to 40 mg/day
16261118|NCT00928941|Behavioral|cognitive training|A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units/hours.
16261119|NCT00928941|Behavioral|video game|An active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours.
16261120|NCT00928928|Procedure|Open colectomy|Open colectomy. Epidural anaesthesia used
16261121|NCT00928928|Procedure|laparoscopic colectomy|Laparoscopic colectomy. Epidural anaesthesia used
16261122|NCT00928915|Drug|Prothrombin complex concentrate (PCC); fresh frozen plasma (FFP)|intravenous, repeated until INR ≤ 1.2
16261123|NCT00928902|Drug|low-dose IL-2|low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)
16261124|NCT00928902|Biological|melanoma vaccine|six melanoma vaccines given over a 6-week period
16261125|NCT00928889|Drug|Nateglinide 120 mg|Nateglinide 120 mg was supplied as tablets.
16261130|NCT00928850|Procedure|radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms|"Cancer cells can spill during surgery and this can cause cancer to return (recur). Some surgeons believe that irrigating could help stop spilling of cancer cells. Irrigating means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery"
16261131|NCT00928850|Procedure|radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms|"Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches (sutures) to the connective tissue (fascia) could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery"
16261132|NCT00928850|Procedure|radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms|Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
16261133|NCT00928850|Procedure|radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms|Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
16261134|NCT00928837|Dietary Supplement|Flavocoxid 500 mg|flavonoid mixture
16261135|NCT00928837|Drug|Naproxen|non-steroidal anti-inflammatory drug
16261136|NCT00928837|Other|Placebo|Placebo
16261137|NCT00928837|Other|flavocoxid 250 mg|Medical food product
16261138|NCT00928824|Dietary Supplement|traditional Japanese diet|10 days of nitrate rich diet (Japanese traditional). After that switch to nitrate low diet for 10 days (European foods). Study nitrate/nitrite in blood, saliva and blood pressure 3 times in each person (10 min each time). A list of Nitrate rich foods are provided.
16261139|NCT00928811|Drug|basiliximab|Simulect 20 mg intravenously day of transplant and day 4
16261140|NCT00928811|Drug|basiliximab|Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration.
16261141|NCT00928798|Drug|Rapamycin|Application of rapamycin 1 mg/ml oral solution to one predefined skin area on one facial half, twice daily 0,25 ml, during 6 months. The other facial half will be similarly treated with a placebo.
16261142|NCT00928798|Drug|placebo|Application of placebo to one predefined skin area on one facial half, during 6 months. The other facial half will be similarly treated with rapamycin 1 mg/ml oral solution
16261143|NCT00928785|Biological|REPEVAX|1 dose of 0.5 mL at Day 0
16261144|NCT00928785|Biological|Monovalent Tetanus vaccine|1 dose of 0.5 mL at Day 0
16261145|NCT00928772|Device|CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM|APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
16261146|NCT00928772|Drug|MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY|CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
16261147|NCT00928772|Other|NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED|NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
16261148|NCT00928746|Device|Ipratropium bromide|
16261149|NCT00928733|Device|Gastroduodenoscopy- Intraduodenal intubation|20 g ethanol diluted up to 10% in tap water
16261150|NCT00928720|Device|CES device|Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
16261151|NCT00928720|Device|sham device|The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.
16261152|NCT00928707|Drug|GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea|50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy
16261153|NCT00928707|Drug|GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea|50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy
16261154|NCT00928694|Drug|fenofibrate (U.S. formulation)|Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
16261155|NCT00928694|Drug|fenofibrate (UK formulation)|Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
16261156|NCT00928681|Biological|Single dose-group A|PF-00547659, single iv dose
16261157|NCT00928681|Biological|Single dose-group A|PF-00547659, single iv dose
16261158|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261159|NCT00928681|Biological|Single dose-group A|PF-00547659, single iv dose
16261160|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261161|NCT00928681|Biological|Single dose-group A|PF-00547659, single dose
16261162|NCT00928681|Biological|Single dose-group A|PF-00547659, single dose
16261163|NCT00928681|Biological|Single dose-group A|PF-00547659, single dose
16261164|NCT00928681|Biological|Single dose-group A|PF-00547659, single dose
16261165|NCT00928681|Biological|Multiple dose-Group B|PF-00547659, multiple dose
16261166|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261167|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261168|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261169|NCT00928681|Biological|Multiple dose- Group B|PF-00547659, multiple dose
16261170|NCT00928681|Biological|Multiple dose-Group B|PF-00547659, multiple dose
16261171|NCT00928668|Drug|Placebo|Placebo device for comparison
16261172|NCT00928668|Drug|Olodaterol (BI1744CL)|Olodaterol comparison of low, medium low, medium high and high doses
16261173|NCT00928668|Drug|Olodaterol (BI1744CL)|Olodaterol comparison of low, medium low, medium high and high doses
16261174|NCT00928668|Drug|Olodaterol (BI1744CL)|Olodaterol comparison of low, medium low, medium high and high doses
16261175|NCT00928668|Drug|Olodaterol (BI1744CL)|Olodaterol comparison of low, medium low, medium high and high doses
16261176|NCT00928655|Drug|acetazolamide|acetazolamide 250mg 1/0/2
16261453|NCT00926900|Drug|Placebo|Placebo
16261177|NCT00928655|Procedure|nocturnal continuous positive airway pressure|continuous positive airway pressure
16261178|NCT00928655|Drug|placebo|placebo capsules
16261179|NCT00928642|Drug|imatinib mesylate by mouth|imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.
16261180|NCT00928642|Drug|Gemcitabine Intravenous|Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
16261181|NCT00928629|Procedure|Ankle-brachial index (ABI) Screening Test|Patients will undergo an ABI measurement
16261182|NCT00928616|Dietary Supplement|margarine + plant sterol esters|margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
16261183|NCT00928616|Dietary Supplement|margarine (placebo)|non-sterol ester supplemented margarine
16261184|NCT00928603|Procedure|Focal Cryoablation|Cryotherapy is administered via the perineum under ultrasound guidance by third-generation 17-gauge cryoprobes using gas and thermal couples. Under transrectal ultrasound guidance cryoprobes are placed approximately 1 cm apart and within 5 mm of the capsule on the side of tumor. The extent of freezing was limited to the area or lobe of the gland with histologically proved tumor.
16261185|NCT00928590|Drug|Travoprost/Timolol Maleate Fixed Combination solution|
16261186|NCT00928564|Drug|Pudendal block|8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.
16261187|NCT00928564|Drug|Placebo|5ml of saline at each block site.
16261188|NCT00928551|Drug|vabicaserin|
16261189|NCT00928538|Other|Enhanced NFP Care|Usual NFP care plus the enhanced care that includes contraceptive administration and distribution during nurse home visits. Participants will have a choice of combined hormonal contraception (oral, patches or vaginal rings)or progestin-only contraception (oral or depomedroxyprogesterone acetate injections.
16261190|NCT00928525|Drug|Imatinib Mesylate|800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
16261191|NCT00928512|Drug|Secukinmab|Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
16261192|NCT00928512|Drug|Placebo|Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.
16261193|NCT00928499|Device|Interstim (SNS)|Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
16261194|NCT00928486|Drug|Lenalidomide|Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle
16261195|NCT00928486|Drug|Dexamethasone|Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle
16261196|NCT00928473|Behavioral|A family-centered, multidisciplinary obesity treatment program|The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
16261197|NCT00928460|Procedure|Removal of preoperative electrocardiogram|A new preanesthesia evaluation strategy without routine ECG. Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG). The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially. At the end of the trial all participating centers will use the new preoperative strategy.
16261198|NCT00928447|Drug|rHuPH20|ID syringe push bolus injection of rHuPH20. Each injection will be administered once daily for 5 days.
16261199|NCT00928447|Drug|Placebo|ID syringe push bolus injection of placebo control. Each injection will be administered once daily for 5 days.
16261200|NCT00928434|Drug|Degarelix|Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.
16261201|NCT00928434|Drug|Degarelix|Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).
16261202|NCT00928434|Drug|Leuprolide|Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)
16261203|NCT00928421|Drug|Polidocanol Endovenous Microfoam 0.125%|Polidocanol Endovenous Microfoam 0.125%, single dose
16261204|NCT00928408|Drug|Cinacalcet|
16261205|NCT00928395|Device|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
16261206|NCT00928356|Procedure|Hybrid CABG/PCI|Same sitting hybrid, robotic CABG/PCI
16261207|NCT00928356|Procedure|Off Pump CABG|Standard of Care Off Pump CABG
16261208|NCT00928343|Drug|GLPG0187|Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
16261209|NCT00928343|Drug|Placebo|Matching subcutaneous or oral placebo
16261210|NCT00928330|Drug|GDC-0941|Oral repeating dose
16261211|NCT00928330|Drug|Trastuzumab|Intravenous repeating dose
16261212|NCT00928330|Drug|trastuzumab-MCC-DM1|Intravenous repeating dose
16261213|NCT00928317|Drug|ART621|3.0mg/kg s.c.
16261214|NCT00928317|Drug|ART621|1.5mg/kg s.c.
16261215|NCT00928317|Drug|ART621|0.75mg/kg s.c.
16261216|NCT00928317|Drug|Placebo|Placebo s.c.
16261217|NCT00928304|Drug|Florbetaben (BAY94-9172)|300 megabecquerels (MBq) as single IV injection of 2 to 10 mL
16261218|NCT00928291|Other|procalcitonin|plasma PCT measurement
16261219|NCT00928291|Drug|antibiotic therapy|antibiotic therapy use
16261220|NCT00928278|Drug|Treatment A|Inhaled, 300/150, single dose
16261221|NCT00928278|Drug|Treatment B|Inhaled, 300/150, single dose
16261222|NCT00928278|Drug|Treatment C|Inhaled, 300/150, single dose + oral activated charcoal block
16261223|NCT00928278|Drug|Treatment D|Inhaled, 300/150, single dose + oral activated charcoal block
16261224|NCT00928265|Device|Endovascular treatment of intracranial aneurysm.|"Neuroform stent is used in conjunction of occlusives devices such as coils. Neuroform Stent allows the treatment of wide neck aneurysm with embolic coils. Put in front of the wide neck, it keeps the coils into the aneurysm and avoids them to fall in the parent artery, preventing coil protrusion.
~Accomplishes this by providing coil support at the neck of the aneurysm"
16261225|NCT00928252|Drug|IV fluorine-18 labeled methylcholine before PET/CT|Intervention at pre-treatment, and at two timepoints post treatment intiation.
16261226|NCT00928239|Procedure|laparoscopic sacropexy with mid vaginal attachment|"supracervical hysterectomy for uterine prolapse
~exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior
~dissection up to ventrolateral part of the levator ani muscle
~Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder
~Two separate meshes, Gynemesh® (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment
~suturing of posterior mesh caudally to levator ani muscle and proximally 4cm from the apex of the vagina or cervical stump
~placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex
~suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2"
16261227|NCT00928239|Procedure|laparoscopic sacropexy with caudal vaginal attachment|"supracervical hysterectomy for uterine prolapse
~exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior
~dissection up to ventrolateral part of the levator ani muscle
~Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder
~Two separate meshes, Gynemesh® (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment
~suturing of posterior mesh caudally to the levator ani muscle and proximally at caudal part of the vagina or cervical stump
~placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex
~suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2"
16261228|NCT00928226|Radiation|Fractionated Stereotactic Radiosurgery (SRS)|Standard of care
16261229|NCT00928226|Procedure|Surgical resection|Standard of care
16261230|NCT00928213|Drug|Progesterone|40 units daily admission
16261231|NCT00928213|Drug|Low molecular weight Heparin|40-80 mg/day
16261232|NCT00928213|Drug|No Drug|no treatment
16261233|NCT00928200|Drug|Erwinase|"The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
~Erwinase will be administered as a 2-hour intravenous infusion."
16261234|NCT00928200|Drug|Vincristine|1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
16261235|NCT00928200|Drug|Dexamethasone|10 mg/m2/day divided BID. Give by mouth days 1-14.
16261236|NCT00928200|Drug|Doxorubicin|60 mg/m2/day IV over 15 minutes on day 1
16261237|NCT00928200|Drug|Cytarabine|Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3 and older
16261238|NCT00928200|Drug|Methotrexate|Given Intrathecally to all patients who are CNS 1 or 2 at study entry. Dose defined by age. Given on day 15 8mg for age 1-1.99 10 mg for age 2-2.99 12 mg for age 3-8.99 15 mg for age 9 and older
16261239|NCT00928200|Drug|Triple Intrathecal Therapy|Methotrexate, Cytarabine and Hydrocortisone given Intrathecally on day 8, 15 and 22 for patients who are CNS 3 at study entry. Doses determined by age.
16261240|NCT00928200|Drug|Dexrazoxane|Due to the limited availability of Dexrazoxane (Zinecard®), treatment will be at the discretion of the treating physician. Dose should be 600 mg/m2 as a IV push immediately prior to anthracycline dose (the elapsed time from the beginning of the dexrazoxane dose to the end of the anthracycline infusion should be 30 minutes or less).
16261241|NCT00928187|Drug|emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)|Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening
16261242|NCT00928187|Drug|abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)|Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening
16261243|NCT00928187|Drug|emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)|Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food
16261244|NCT00928174|Drug|IV administration of fluorine-18 fluorocholine followed by PET/CT imaging|Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
16261245|NCT00928161|Drug|Dexlansoprazole|Dissolving tablet taken by mouth (60 mg tablet), once a day. Take dose first thing in morning on empty stomach, then nothing but water for 30-45 minutes afterwards.
16261246|NCT00928148|Drug|SPD465|50 or 75 mg once daily for 7 days
16261247|NCT00928148|Drug|Immediate Release Amphetamine Salt|25 mg once daily for 7 days
16261248|NCT00928148|Drug|Placebo|Once daily for 7 days
16261249|NCT00928135|Drug|Xylitol|15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)
16261250|NCT00928135|Drug|Hypertonic saline|7% hypertonic saline solution for aerosol; Dosage: 5 ml twice a day (BID)
16261251|NCT00928122|Device|Intrastromal Correction of Presbyopia|Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
16261252|NCT00928122|Device|Intrastromal correction of Myopia|Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
16261253|NCT00928122|Device|Intrastromal Correction of Hyperopia|Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
16261254|NCT00928122|Device|Intrastromal Correction of Myopia incl. Astigmatism|Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
16261255|NCT00928122|Device|Intrastromal Correction of Hyperopia incl. Astigmatism|Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
16261256|NCT00928109|Behavioral|CBCT|Cognitive Behavioral Couples Therapy - weekly manualized couples therapy
16261257|NCT00928109|Behavioral|Family Supportive Therapy|Couples meet once a week for an hour for a period of 20 weeks for couples therapy. Family Supportive Therapy is not manualized and is the standard form of care at the UNC Eating Disorders Program
16261258|NCT00928083|Drug|OZ439 50mg API capsules|
16261260|NCT00928083|Drug|OZ439 400mg aqueous dispersion|
16261261|NCT00928083|Drug|OZ439 800mg aqueous dispersion|
16261262|NCT00928083|Drug|OZ439 100mg API capsules|OZ439 100mg (2x50mg API capsules)
16261263|NCT00928083|Drug|OZ439 400mg API capsules|OZ439 400mg (2x200mg API capsules)
16261264|NCT00928083|Drug|OZ439 1600mg aqueous dispersion|
16261265|NCT00928083|Drug|OZ439 800mg API capsules|OZ439 800mg (4x200 API capsules)
16261266|NCT00928083|Drug|OZ439 1200mg API capsules|OZ439 1200mg (6x200mg API capsules)
16261267|NCT00928083|Drug|Placebo|
16261268|NCT00928083|Drug|OZ439 200mg aqueous dispersion|
16261269|NCT00928070|Drug|Fesoterodine|Fesoterodine 4 mg and 8 mg
16261270|NCT00928070|Drug|Placebo|Placebo sham 4 mg and 8 mg
16261271|NCT00928057|Device|4mm x 32G pen needle|For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.
16261272|NCT00928057|Device|8mm x 31G pen needle|For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
16261273|NCT00928057|Device|5mm x 31G pen needle|For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.
16261274|NCT00928018|Drug|Sirolimus|Taken orally for at least 12 months
16261275|NCT00928018|Drug|Methotrexate|Given intravenously on the first, third and sixth day after transplant
16261276|NCT00928018|Drug|Tacrolimus|Taken orally or given intravenously for at least 6 months
16261277|NCT00928018|Drug|Cyclosporine|Taken orally or given intravenously for at least 6 months
16261278|NCT00928018|Drug|MMF|Taken orally for about 2 months
16261279|NCT00928005|Behavioral|Weight loss diet|The weight loss diet will follow the American Diabetes Association guidelines and be nutritionally balanced with a reduced saturated fat content.
16261280|NCT00928005|Behavioral|Weight loss diet plus exercise|The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.
16261281|NCT00927992|Other|Epidemiological Non interventional|Epidemiological Non interventional
16261282|NCT00927979|Drug|10 mLRopivacaine 1%|Intraperitoneal nebulization of 10 mL Ropivacaine 1%
16261283|NCT00927979|Drug|Water for injection|Intraperitoneal nebulization of 10 mL water for injection
16261284|NCT00927979|Drug|10 mL Ropivacaine 1%|Intraperitoneal nebulization of 10 mL Ropivacaine 1%
16261285|NCT00927966|Drug|RAD001|Taken orally once a day.
16261286|NCT00927966|Drug|CP-751,871|Given intravenously on Day 1 of a 21-day cycle
16261287|NCT00927953|Biological|MGAWN1|Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0.
16261288|NCT00927953|Biological|Placebo - normal saline|Normal Saline intravenous, volume same as active comparator, one dose at Day 0
16261289|NCT00927940|Device|MDT-4107 Drug Eluting Stent|Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
16261290|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261291|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261292|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261293|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261294|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261295|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261296|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261297|NCT00927927|Drug|NNC0142-0002|Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
16261298|NCT00927927|Drug|placebo|Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
16261299|NCT00927927|Drug|NNC0142-0002|Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
16261300|NCT00927927|Drug|NNC0142-0002|Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
16261301|NCT00927927|Drug|NNC0142-0002|Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
16261302|NCT00927927|Drug|NNC0142-0002|Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
16261303|NCT00927927|Drug|NNC0142-0002|Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
16261304|NCT00927927|Drug|placebo|Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
16261305|NCT00927914|Drug|Ranirestat|Ranirestat 40 mg tablets
16261306|NCT00927914|Drug|Placebo|Placebo tablets
16261307|NCT00927901|Drug|Indacaterol maleate 400 μg|Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
16261308|NCT00927901|Drug|Indacaterol acetate 400 μg|Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
16261309|NCT00927901|Drug|Indacaterol xinafoate 400 μg|Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
16261310|NCT00927901|Drug|Placebo to indacaterol|Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler.
16261311|NCT00927888|Drug|Bupivacaine Block|Bupivacaine local anesthesia block prior to start of FESS procedure.
16261312|NCT00927888|Drug|Placebo|placebo is identical in appearance in comparison to active drug.
16261313|NCT00927875|Drug|BMS-833923|Capsule, Oral, starting dose 30 mg, once daily, continuous
16261314|NCT00927875|Drug|Carboplatin|Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles
16261315|NCT00927875|Drug|Etoposide|Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, & 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles
16261316|NCT00927862|Genetic|IWPC adapted genotype-guided dosing algorithm for warfarin|"Within the first or second dose, apply an International Warfarin Pharmacogenetics Consortium (IWPC) adapted genotype-guided dosing algorithm to determine the daily maintenance dose of warfarin, based on clinical factors (age, sex, weight, height, etc.), and VKORC1 and CYP2C9 genotypes, to individualize the initial dosing of warfarin. (IWPC algorithm submitted for publication, 5-08)
~Note that a second comparison will be made between the combined genotype-guided dosing groups (standard and modified IWPC warfarin dosing algorithms) and a historical comparator group."
16261317|NCT00927862|Genetic|Modified IWPC genetic-guided warfarin dosing algorithm|"Within the first or second warfarin dose, apply a modified International Warfarin Pharmacogenetics Consortium (IWPC)-adapted genotype-guided dosing algorithm to determine the daily maintenance dose of warfarin. The active comparator algorithm (see above) will be further modified to account for the temporal pharmacodynamics of warfarin metabolism, e.g., by ignoring the CYP2C9 variants for the first 2 days.
~Note that a second comparison will be made between the combined genotype-guided dosing groups (standard and modified IWPC warfarin dosing algorithms) and a historical comparator group."
16261318|NCT00927862|Other|Standard of care treatment|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic cohorts (July 2008-December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed.
16261319|NCT00927849|Procedure|lateral internal sphincterotomy (LIS)|closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
16261320|NCT00927849|Drug|Glycerin trinitrate (GTN)|All were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
16261321|NCT00927849|Drug|botulinum toxin injection (BTX A)|All were injected with botulinum toxin injection (BTX- A) in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
16261322|NCT00927836|Biological|Filgrastim|135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
16261323|NCT00927836|Drug|Sodium chloride solution|Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
16261324|NCT00927823|Drug|PF-04691502|Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation.
16261325|NCT00927810|Drug|Canakinumab|
16261326|NCT00927797|Drug|Cyclophosphamide, Pentostatin, Rituximab|
16261327|NCT00927784|Biological|Mesenchymal Precursor cells (RevascorTM)|Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs (in sequential cohorts).
16261328|NCT00927784|Drug|Cryoprotective media alone|Participants will receive intramyocardial injections of cryoprotective media (placebo).
16261329|NCT00927771|Drug|azelaic acid gel|azelaic acid 15% gel twice a day for 6 months
16261330|NCT00927771|Drug|hydroquinone cream|hydroquinone 4% cream twice a day for 6 months
16261331|NCT00927758|Drug|fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg|fluticasone propionate/salmeterol diskus
16261332|NCT00927745|Device|AutoFlow mode on Evita 4 Dräger ventilators|Activation of AutoFlow mode during assist-controlled ventilation
16261333|NCT00927745|Device|Evita 4 Dräger ventilators|Assist-controlled ventilation without activation of AutoFlow mode
16261334|NCT00927732|Drug|hydroquinidine|capsules of 300 mg LP, 1 or 2 or 3 times per day : frequency will be determined by tests after patient inclusion before her/his randomization
16261335|NCT00927732|Drug|placebo (sugar)|capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine
16261336|NCT00927719|Biological|ACAM2000® smallpox vaccine|Previous vaccination, no vaccine is administered in this study.
16261337|NCT00927706|Device|Assistive technology updating and tune up intervention|This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
16261338|NCT00927693|Other|Coronary Artery Calcium (CAC) Scan|A coronary artery calcium (CAC) scan is performed during the baseline clinic visit. The results including the actual images from the scan are viewed by the subject during the risk factor consultation with the nurse practitioner. Results are available for the subjects' physicians upon request.
16261339|NCT00927667|Procedure|No Drug|Patients have received primary FVIII prophylaxis (started < 2 years of age)
16261340|NCT00927667|Procedure|No Drug|Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
16261341|NCT00927667|Procedure|No Drug|Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
16261342|NCT00927667|Procedure|No Drug|Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
16261343|NCT00927667|Procedure|No Drug|Patients have received on-demand therapy
16261344|NCT00927654|Drug|Iloprost (Ventavis)|Twice 20 µg at day 0 (total dose 40 µg) intraoperatively
16261345|NCT00927654|Drug|Isotonic Sodium Chloride solution 0.9 % (placebo)|Twice at day 0 intraoperatively
16261346|NCT00927641|Drug|Ketoprofen Patch|Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
16261347|NCT00927641|Other|Placebo Patch|Two placebo patches placed on target ankle once daily for 14 days
16261348|NCT00927628|Procedure|Vitrectomy|Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular holes. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were >40-years-of-age.
16261349|NCT00927615|Drug|abciximab|0.25 mg/kg body weight (intracoronary)
16261350|NCT00927615|Drug|abciximab|0.25 mg/kg body weight (intravenous)
16261351|NCT00927602|Drug|fondaparinux|once daily sc injection, 1,5 mg, max 14 days
16261352|NCT00927589|Drug|carboplatin|Intravenous repeating dose
16261353|NCT00927589|Drug|docetaxel|Intravenous repeating dose
16261354|NCT00927589|Drug|trastuzumab|Intravenous repeating dose
16261355|NCT00927576|Behavioral|Digit span testing|Testing of short-term verbal memory with digit span
16261356|NCT00927576|Behavioral|Spatial span testing|Testing of short-term visuospatial memory with spatial span.
16261357|NCT00927576|Behavioral|Finger tapping|Testing motor speed with a finger tapping test.
16261358|NCT00927576|Behavioral|Simple reaction time|Testing the time to respond to the appearance of a visual stimulus.
16261359|NCT00927576|Behavioral|Choice reaction time|Testing the time needed to discriminate and respond to different visual stimuli.
16261360|NCT00927576|Behavioral|Verbal fluency|Evaluating how many words are produced in 90s.
16261361|NCT00927576|Behavioral|Verbal list learning|Evaluating short-term memory, learning, and memory interference in the recall of 12-word lists, presented three times. Evaluating long-term memory and recognition after a 20 min interval.
16261362|NCT00927576|Behavioral|Trail making test|Evaluating visuomotor speed and executive function in Trail Making Tests, A and B. In the first, subjects connect successive numbers with the mouse. In the second, they connect numbers and letters in alternation.
16261363|NCT00927576|Behavioral|Design fluency|Subjects create the maximal number of 4-line patterns in 90 s.
16261364|NCT00927576|Behavioral|Questionnaire completion|Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire.
16261365|NCT00927563|Drug|Tolcapone|pill, 100-300mg/day for 8 weeks
16261366|NCT00927550|Drug|lithium|Patients allocated to lithium will be administered an oral starting dose ranging between 150 and 300 milligrams. Suggested final oral dose will have to achieve plasma levels of 0.4 to 1.0 mmol/L. Clinicians will be free of increasing or decreasing the dose according to clinical status and circumstances. Dose changes will be recorded. Following randomization, treatment is to be taken daily for 1 year unless some clear reason to stop develops. Patients allocated to the lithium arm will receive usual pharmacological and non-pharmacological treatment as clinically indicated. Any other pharmacological treatment will be allowed.
16261367|NCT00927550|Drug|usual care|Patients allocated to the control arm will receive usual pharmacological and non-pharmacological treatment as clinically indicated. Patients allocated to the control arm will not be allowed to receive lithium. Any other pharmacological treatment will be allowed.
16261368|NCT00927537|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Patients under daily life treatment receiving Kinzal according to local drug information.
16261369|NCT00927537|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide|Patients under daily life treatment receiving Kinzalplus according to local drug information.
16261370|NCT00927524|Drug|Insulin glulisine|Dose injection of insulin glargine (Lantus®) given subcutaneously in the abdomen 1 hour prior to breakfast and a dose of insulin glulisine (Apidra®) at a dose based upon your (body wt.) carbohydrate intake for each of the three meals (breakfast, lunch and dinner).
16261371|NCT00927524|Drug|Insulin|Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner.
16261372|NCT00927511|Drug|Fulvestrant|Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations, then 250 mg every 28 days, until progression or unacceptable toxicity vs Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity
16261373|NCT00927498|Drug|conventional chemotherapy (AraC + Daunorubicin),|"Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.
~Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4."
16261374|NCT00927498|Drug|Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),|"Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.
~Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
~Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1."
16261375|NCT00927485|Drug|Calcumin (Curcumin)|Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
16261376|NCT00927485|Other|Risk Factor Questionnaire|Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
16261377|NCT00927485|Other|Blood samples|Three tubes of blood at visits 0, 4 and 12 months.
16261378|NCT00927485|Other|Biopsies (Sigmoidoscopy)|Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
16261379|NCT00927485|Other|Biopsies (Upper endoscopy)|Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.
16261380|NCT00927472|Drug|Malathion gel 0.5%|Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
16262838|NCT00916006|Drug|Vehicle gel|Vehicle gel, three day treatment
16261381|NCT00927472|Drug|Permethrin 1% rinse|Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
16261382|NCT00927459|Drug|PRO-040201|Single dose IV infusion
16261383|NCT00927459|Drug|Placebo|placebo
16261384|NCT00927446|Procedure|Endoscopy screening with narrow band imaging|Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions.
16261385|NCT00927433|Behavioral|Psychoeducational intervention for cancer-related fatigue|Patients received education on fatigue management in groups of ten patients over two weeks in three two hour sessions
16261386|NCT00927407|Drug|Malathion gel 0.5%|Malathion gel 0.5% applied to the scalp for 30 minutes
16261387|NCT00927407|Drug|Malathion lotion 0.5%|Malathion lotion 0.5% applied to scalp for 12 hours
16261388|NCT00927394|Drug|Aliskiren|Aliskiren 150 mg tablet
16261389|NCT00927394|Drug|Valsartan|Valsartan 160 mg capsules
16261390|NCT00927394|Drug|Placebo for Aliskiren|Placebo for Aliskiren 150 mg tablets
16261391|NCT00927394|Drug|Placebo for Valsartan|Placebo for Valsartan 160 mg capsules
16261392|NCT00927368|Procedure|ultrasound guidance alone|The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.
16261393|NCT00927368|Procedure|ultrasound guidance and needle stimulation|For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.
16261394|NCT00927368|Procedure|ultrasound guidance and catheter stimulation|The Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
16261395|NCT00927355|Drug|Pioglitazone|6 month treatment with pioglitazone 15mg for four weeks with dose increased to 30mg if no adverse effects (swelling of lower extremities, liver enzyme elevation) noted at the four week mark.
16261396|NCT00927355|Drug|Placebo|"The placebo pills also start out with one (15mg) pill qday and are increased to 2 tablets (30mg) qday after 4 weeks if no adverse effects are noted by study physician."
16261397|NCT00927342|Other|Vivostat|Patients with an air leak at the end of thoracic surgery despite conventional measures(diathermy, suturing and/or stapling) will receive Vivostat sealant applied to the surface of the lung in an attempt to eliminate air leak
16261398|NCT00927342|Other|BioGlue|Patients with an air leak at the end of thoracic surgery despite conventional measures(diathermy, suturing and/or stapling) will receive Bioglue sealant applied to the surface of the lung in an attempt to eliminate air leak
16261399|NCT00927329|Biological|dust mite inhalation|Nasal allergen challenge will be provided in a graded dose fashion of 0 AU, 100 AU, 500 AU, and 1000 AU separated by 20 minutes.
16261400|NCT00927316|Biological|E. coli 83972|"Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).
~Placebo arm: Identical procedure but with saline, 30 ml."
16261401|NCT00927303|Device|Cirrus-Spectralis|512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter
16261402|NCT00927303|Device|Spectralis-Cirrus|retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter
16261403|NCT00927290|Drug|Pioglitazone|Pioglitazone, 45 mg QD (30 mg QD the first month)
16261404|NCT00927290|Drug|Placebo|Placebo 45 mg QD (30 mg QD the first month)
16261405|NCT00927277|Device|Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser|The Erchonia(R) EML Laser is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated.
16261406|NCT00927277|Device|Erchonia(R) LipoLASER PL|
16261407|NCT00927264|Behavioral|Motivational Interviewing Intervention for ETS Reduction|The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so.
16261408|NCT00927264|Behavioral|Educational Program for ETS Reduction|An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
16261409|NCT00927251|Device|Pacing Lead (Model 4296 LV Lead)|Implant and follow-up of study device
16261410|NCT00927238|Device|XL TDR|This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
16261411|NCT00927238|Other|Lumbar fusion surgery|Lumbar fusion surgery
16261412|NCT00927225|Drug|ropivacaine 0.2%, 50 mL|
16261413|NCT00927225|Drug|normal saline|
16261414|NCT00927212|Drug|AS101 ointment|Twice daily topical application
16261415|NCT00927199|Dietary Supplement|High-Oleic Canola Oil|Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))
16261416|NCT00927199|Dietary Supplement|High-Oleic Canola/Flaxseed Oil Blend|Diets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid))
16261588|NCT00925808|Behavioral|Questionnaires|Survey tools and VTE Symptom Follow-up Questionnaire
16261417|NCT00927199|Dietary Supplement|Western Dietary Control|Diets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid))
16261418|NCT00927186|Drug|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.
~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
16261419|NCT00927186|Drug|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.
~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
16261420|NCT00927173|Device|Brainsway H-Coil Deep TMS System|Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions
16261421|NCT00927173|Device|Brainsway H-Coil Deep TMS System (Sham treatment)|In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
16261422|NCT00927147|Radiation|BNCT|Boronophenylalanine infusion followed by neutron irradiation
16261423|NCT00927147|Drug|cetuximab|cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions
16261424|NCT00927134|Genetic|retroviral SF71-gp91phox transduced CD34+ cells|autologous ex-vivo transduced (SF71-gp91phox)CD34+ cells
16261425|NCT00927121|Device|Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset|"The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity.
~Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation.
~The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system"
16261426|NCT00927108|Other|Progenitor Stem Cell Culture|
16261427|NCT00927095|Drug|Continuous OC (EE/DROS)|Continuous EE(20ug)+DROS(3mg) daily for 3 months
16261428|NCT00927095|Drug|Intermittent OC (EE/DROS)|Intermittent EE(20ug)+DROS(3mg) daily for 21 days each month
16261429|NCT00927095|Drug|placebo|daily placebo
16261430|NCT00927082|Drug|peginterferon alfa-2a [Pegasys]|90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
16261431|NCT00927069|Drug|Adalimumab every other week|Adalimumab 40mg injection every other week for 24 weeks
16261432|NCT00927069|Drug|Adalimumab Every Week|Adalimumab 40mg injection every week for the last 12 weeks of study.
16261433|NCT00927056|Procedure|Microdiscectomy|Minimally invasive microdiscectomy versus conventional open microdiscectomy
16261434|NCT00927043|Other|Epidemiological study according to clinical practice|Epidemiological study according to clinical practice.
16261435|NCT00927030|Drug|supplemental liquid melatonin|Liquid melatonin will be given to the parent. There are 4 dose levels (1mg, 3mg, 6 mg, and 9mg)of melatonin that will be used at 3 week intervals. The child will start with 1mg and the dose will be increased at 3 week intervals until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. Once this goal is reached the child will stay on that dose through the remainder of the study.
16261436|NCT00927030|Drug|flavored liquid or liquid supplemental melatonin|Single blind for parents at initial 3-weeks dose period of 1 mg melatonin for 18 children where 3/18 children will receive placebo and 15/18 children will receive melatonin study drug. Each bottle will be labeled as: Flavored liquid placebo/or liquid melatonin. After this initial 3-week period all children will receive known melatonin in bottles that state this.
16261437|NCT00927017|Other|Liquorice 66 g/day|Liquorice 66 g/day for two weeks
16261438|NCT00927017|Other|Liquorice 102 g/day|Liquorice 102 g/day for two weeks
16261439|NCT00927004|Drug|Etoricoxib (Arcoxia)|60 mg, daily dose, oral delivery, 14 days duration
16261440|NCT00927004|Drug|Sugar pill|Daily dose (1 pill), oral delivery, 14 days
16261441|NCT00926991|Other|No intervention|No intervention; observation only
16261442|NCT00926978|Radiation|Radioactive Iodine 124|"After TSH stimulation with Recombinant human TSH (rhTSH) for 2 days, a dose of radioactive iodine 124 ( I-124) 1.7 mCi is administrated orally and PET imaging is done for 5 continuous days including the day of the dose administration. On each day, just before imaging, 5 ml of blood is drawn.
~Patients will be randomized to either the sequence above (e.g. I-131 followed by I-124) or to the reverse sequence in which the I-124 is given first followed by the I-131. If I-124 is administered first and as long as the whole body retention is < 2% by the start of the second rhTSH stimulation, the I-124 will not interfere with the I-131."
16261443|NCT00926965|Drug|amisulpride|amisulpride tablet 100-1200mg/day for 24 months
16261444|NCT00926965|Drug|Olanzapine|Olanzapine tablet 2.5 to 30 mg/day for 24 months
16261445|NCT00926965|Drug|Conventional antipsychotics|the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics
16261446|NCT00926952|Drug|Methylaminolevulinate (Metvix, Metvixia)|2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4.
16261447|NCT00926952|Device|Photodynamic Therapy (Aktilite)|Device set to 37 J/cm². Red light wavelength is approximately 630 nm.
16261448|NCT00926939|Behavioral|Reinforcement for the abstinence of smoking|Participants in this intervention group will receive vouchers contingent upon a CO sample of 4ppm or less.
16261449|NCT00926939|Behavioral|Reinforcement for submission of videos with CO sample|This intervention group will receive vouchers contingent on their submission of videos of their CO breath tests.
16261450|NCT00926926|Drug|Oxybutynin Chloride Gel|Once daily for 7 days, followed by single dose of acetaminophen
16261451|NCT00926926|Drug|Placebo Gel|Once daily for 7 days, followed by single dose of acetaminophen
16261452|NCT00926900|Drug|D-cycloserine|50 mg at approximately 1.5 hours prior to cue-exposure training sessions
16261454|NCT00926887|Device|Erchonia(R) EML Laser|Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
16261455|NCT00926887|Device|Placebo Laser|Inactive light
16261456|NCT00926861|Device|ultrasound|A-scan and B-scan ultrasound at baseline and month 6,12,24
16261457|NCT00926861|Device|OCT|Volume scans of spectralis OCT at baseline and month 6,12,24
16261458|NCT00926848|Behavioral|Partners Together in Health (PaTH) Intervention|Patients and partners in the PaTH experimental group participated in 18-36 exercise and 18 educational sessions in a structured cardiac rehabilitation program. Patients in the Usual care group also participated in 18-36 exercise and 18 educational sessions; partners, however, only participated in the educational sessions.
16261459|NCT00926835|Drug|paroxetine|6 weeks, 20-50mg/day
16261460|NCT00926835|Drug|Escitalopram|10-20mg/day for 6 weeks
16261461|NCT00926835|Drug|Venlafaxine XR|Venlafaxine 75-225mg/day for 6 weeks
16261462|NCT00926835|Drug|Paroxetine+Bupropion|paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
16261463|NCT00926835|Drug|Paroxetine+Lamotrigine|Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
16261464|NCT00926835|Drug|Paroxetine+Lithium|Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
16261465|NCT00926835|Drug|Escitalopram+Mirtazapine|escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
16261466|NCT00926835|Drug|Escitalopram+Aripiprazole|escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
16261467|NCT00926835|Drug|Paroxetine + Venlafaxine XR|Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks
16261468|NCT00926809|Drug|Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin|Lansoprazole, Amoxicillin 1000 mg, Clarithromycin 500 mg
16261469|NCT00926809|Drug|Lansoprazole (proton pump inhibitor), placebo|Lansoprazole, Amoxicillin placebo, Clarythromycin placebo
16261470|NCT00926796|Drug|Azithromycin|Four 500 mg tablets will be administered orally to equal a 2 gm dose.
16261471|NCT00926796|Drug|Gentamicin|Fixed dose of 240 mg intramuscular one time for patients >45 kg and a 5 mg/kg dose for patients less than or equal to 45 kg based on their measured weight in clinic. Most patients will require 2 injections of gentamicin in separate large muscle groups.
16261472|NCT00926796|Drug|Gemifloxacin|One 320 mg tablet administered orally.
16261473|NCT00926783|Procedure|CFAE ablation|CFAE ablation (targeted vs. generalized)
16261474|NCT00926757|Drug|Entecavir prophylaxis|Entecavir 0.5mg daily from day 1 of chemotherapy to 3 months after completing chemotherapy
16261475|NCT00926757|Drug|Therapeutic entecavir|Entecavir 0.5cm daily since hepatitis flare and HBV reactivation, till hepatitis remission
16261476|NCT00926744|Behavioral|physical activity|The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
16261477|NCT00926731|Drug|AZD1152|Variable dose via a 7-day continuous infusion
16261478|NCT00926731|Drug|LDAC (low dose cytosine arabinoside)|20 mg subcutaneous injection given twice daily
16261479|NCT00926718|Drug|remifentanil infusion|rocuronium dose 0 mg/kg + remifentanil infusion of 2ng ml-1
16261480|NCT00926718|Drug|rocuronium dose + remifentanil infusion|rocuronium dose 0.4 mg/kg+ remifentanil infusion of 2ng ml-1
16261481|NCT00926718|Drug|rocuronium dose + remifentanil infusion|rocuronium dose 0.6 mg/kg+ remifentanil infusion of 2ng ml-1
16261482|NCT00926718|Drug|remifentanil infusion|rocuronium dose 0 mg/kg + remifentanil infusion of 8ng ml-1
16261483|NCT00926718|Drug|rocuronium dose + remifentanil infusion|rocuronium dose 0.4 mg/kg+ remifentanil infusion of 8ng ml-1
16261484|NCT00926718|Drug|rocuronium dose + remifentanil infusion|rocuronium dose 0.6 mg/kg+ remifentanil infusion of 8ng ml-1
16261485|NCT00926705|Drug|Dexmedetomidine and Fentanyl|Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.
16261486|NCT00926705|Drug|Fentanyl|This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
16261487|NCT00926692|Other|Blood draw|Subject will have blood draw.
16261488|NCT00926666|Drug|Levobupivacaine|Dose finding study for levobupivacaine in fractured neck of femur patients. Ultrasound guided anterior psoas compartment nerve block to determine EC50 using up/Down methodology in patient before surgery to fix broken hip.
16261489|NCT00926653|Drug|Escitalopram|10 to 20 mg daily as part of another study in which participants are enrolled
16261490|NCT00926640|Drug|Belinostat|6 cycles of belinostat 400 mg/m2/24h X2 administered by CIV
16261491|NCT00926640|Drug|Cisplatin|6 cycles at 60mg/m2 IV on day 2
16261492|NCT00926640|Drug|Etoposide|6 cycles 80 mg/m2 IV daily X3 beginning day 2.
16261493|NCT00926627|Drug|bosentan|62.5 mg tablets b.i.d. administered orally for 4 weeks followed by the maintenance dose of 125 mg b.i.d. (62.5 mg b.i.d. if body weight < 40 kg/90 lb)
16261494|NCT00926627|Drug|placebo|identical preparation as the study drug, but without the active substance, administered b.i.d.
16261495|NCT00926614|Drug|pioglitazone (Actos)|pioglitazone 30 mg qd for 30 days, then increase to 45 mg
16261496|NCT00926614|Drug|atorvastatin (Lipitor)|atorvastatin 40 mg for 30 days then increase to 80 mg daily
16261497|NCT00926588|Drug|Stepped care|Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
16261498|NCT00926575|Drug|oral beclomethasone 17,21-dipropionate|Two tablets QID for 50 days
16261499|NCT00926575|Drug|Placebo|Two tablets QID for 50 days
16261500|NCT00926562|Drug|Iopromide (Ultravist)|Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
16261501|NCT00926562|Drug|Iodixanol (Visipaque)|Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
16261502|NCT00926549|Device|Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)|macular cube scanning
16261503|NCT00926536|Device|C-arm CT + DSA as needed|C-arm CT images obtained and supplemented with DSA if needed
16261504|NCT00926536|Device|DSA only|DSA imaging only
16261505|NCT00926523|Other|Blood Gas|Subject will have both venous and arterial blood draws to assess for the bloods content of MIF
16261506|NCT00926523|Other|Pulmonary Exercise Test|Subject will ride exercise bike to assess their pulmonary function level.
16261507|NCT00926523|Other|Spirometry|To assess subjects lung function
16261508|NCT00926523|Other|Breath Condensate Collector|Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.
16261509|NCT00926510|Behavioral|Language toolkit|Simple toolkit of interactive things to stimulate language.
16261510|NCT00926510|Behavioral|Safety counseling|Smoke detector and general safety counseling
16261511|NCT00926497|Other|Procalcitonin-guided decision making|Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
16261512|NCT00926471|Behavioral|Cognitive Behavioral Therapy (CBT) Program|12 to 14 weekly sessions of individual CBT and parent training with 5 sessions of group counseling every other week
16261513|NCT00926432|Device|EOS™ Acquisition|Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.
16261514|NCT00926432|Device|EOS™ Acquisition|Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.
16261515|NCT00926419|Biological|Varicella Vaccine|Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
16261516|NCT00926419|Biological|Hepatitis A Vaccine|Hepatitis A virus vaccine, inactivated, Single dose
16261517|NCT00926406|Drug|lead chelation therapy|Patients with lead poisoning (BLL> 20μg/dl) are randomly assigned to a control or chelation group, on the 1:1 proportion. During the 3 months, 50 chelation group patients receive 2-hour weekly intravenous infusions of one vial (1 g) of calcium di-sodium EDTA mixed with 200 ml of normal saline until BLB is BLL < 5 μg/dl. Fifty control patients receive weekly 2-hour infusions of one vial (20 ml) of 50% glucose mixed with 200 ml of normal saline over a period of 12 weeks9.
16261518|NCT00926393|Drug|Quetiapine Immediate Release|Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
16261519|NCT00926393|Drug|Quetiapine Extended Release|Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
16261520|NCT00926380|Drug|denosumab|denosumab: 60 mg SC every 6 months
16261521|NCT00926380|Drug|teriparatide|teriparatide: 20 mcg SC QD
16261522|NCT00926367|Drug|Clindamycin and benzoyl peroxide|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.
16261523|NCT00926367|Drug|benzoyl peroxide 2.5% and adapalene 0.1% gel|Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel
16261524|NCT00926354|Drug|AS101|intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.
16261525|NCT00926341|Drug|Pioglitazone|Tab. Pioglitazone-30 mg/day, oral, 24 weeks
16261526|NCT00926341|Drug|Telmisartan|Tab. Telmisartan- 40 mg/day, oral, 24 weeks
16261527|NCT00926328|Drug|Triclosan, fluoride|Six Month study, brush twice daily
16261528|NCT00926328|Drug|Fluoride|twice daily usage
16261529|NCT00926315|Drug|calcitriol|Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
16261530|NCT00926315|Drug|Calcitriol|calcitriol 0.25 mcg PO bid
16261531|NCT00926302|Drug|Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)|Levetiracetam 500mg/tablet Oral once
16261532|NCT00926302|Drug|Keppra (Levetiracetam - USB SA Pharma Sector)|Levetiracetam 500mg/tablet oral once
16261533|NCT00926289|Drug|Telmisartan|Telmisartan 80mg
16261534|NCT00926289|Drug|Telmisartan|Telmisartan 80mg
16261535|NCT00926289|Drug|Hydrochlorothiazide|Hydrochlorothiazide25mg
16261536|NCT00926276|Procedure|Fundoplication|Fundoplication
16261537|NCT00926263|Biological|CP-751,871|single dose, 1-hr IV infusion
16261538|NCT00926263|Biological|CP-751,871|single dose, 1-hr IV infusion
16261539|NCT00926263|Biological|CP-751,871, moxifloxacin, saline|Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion
16261540|NCT00926250|Dietary Supplement|Oral PS-IPC supplement|Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention. The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
16261541|NCT00926250|Dietary Supplement|Placebo supplement|Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention. The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
16261542|NCT00926237|Device|Sham rTMS - Sham repetitive transcranial magnetic stimulation|Sham rTMS will be delivered using a commercially available sham coil and targeted to the same brain site in the temporal lobe and in a manner identical to that for active rTMS except that scalp electrodes are used to stimulate the temporalis muscle electrically during sham stimulation to replicate the feel of active TMS.
16261543|NCT00926237|Device|Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency|Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 1 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.
16261544|NCT00926237|Device|Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency|Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 10 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.
16261545|NCT00926224|Device|FibroScan M and XL probes|Each patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe
16261546|NCT00926211|Device|ARTAS™ System|Hair harvest using a computer-assisted system
16261547|NCT00926211|Procedure|Manual Hair Harvest|Hair harvesting via the manual technique
16261548|NCT00926185|Drug|Lifitegrast|Ophthalmic Solution
16261549|NCT00926185|Drug|Placebo|Ophthalmic Solution
16261587|NCT00925821|Drug|RAD|After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
16263263|NCT00912964|Drug|Placebo|Matching mirabegron placebo tablets.
16261550|NCT00926146|Behavioral|NCMIT|Nurse Case Management Plus Contingency Management and Tracking (NCCMT) Program includes 20 minute case management, delivered by the NCCMT nurse and a separate 45 minute culturally competent specialized education, delivered by the two assigned nurses and research assistants weekly over 8 weeks. Participants of this group will also receive the HBV vaccine subsequently at one month and four months after baseline and incentives for three-weekly urine samples.
16261551|NCT00926146|Behavioral|SCMIT|Standard with Contingency Management and Tracking (SCMT) Program. Participants in the SCMT group will interact three times a week over the four-month intervention period with the research nurse and research assistant and will be offered: 1) a brief HBV/HCV education program; 2) receipt of the vaccine subsequently at one month and four months after baseline; and 3) voucher incentives for three-weekly urine samples. The SCMT participants will not receive the specialized education sessions nor the case management delivered weekly over the first 8 weeks sessions.
16261552|NCT00926133|Other|OGTT|Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.
16261553|NCT00926120|Dietary Supplement|Mogroside sweetener (PureLo)|Mogroside sweetener administered at a dosage level of 5g every 6 hours for 14 days
16261554|NCT00926107|Drug|Temsirolimus|Temsirolimus 25mg weekly until clinical progression
16261555|NCT00926081|Behavioral|Supervised exercise training|A standardized supervised exercise training program
16261556|NCT00926068|Drug|HO/03/03 10µg|
16261557|NCT00926068|Drug|Placebo|
16261558|NCT00926055|Drug|Ezetrol (Ezetimibe)|Ezetrol - 10 mg once daily for 3 months
16261559|NCT00926055|Drug|Vytorin (Ezetimibe + Simvastatin)|Vytorin - 10/20 mg once daily for 3 months
16261560|NCT00926029|Drug|Fluoride|Brush twice daily
16261561|NCT00926029|Drug|Triclosan, fluoride|Brush twice daily
16261562|NCT00926029|Other|Metal salt|Brush twice daily
16261563|NCT00926016|Drug|Pioglitazone (Actos)|pioglitazone 45 mg a day
16261564|NCT00926003|Behavioral|Full Computerized cognitive training|8 weeks of 3 times weekly intervention for 60 min per session with the full titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning
16261565|NCT00926003|Behavioral|Limited computerized cognitive training|Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training. 8 weeks of 3 times weekly intervention for 60 min per session with the non-titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning).
16261566|NCT00925990|Drug|ribavirin|200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
16261567|NCT00925990|Drug|CTS-1027|5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks
16261568|NCT00925990|Drug|Placebo for ribavirin|Capsules identical to ribavirin in appearance containing inactive ingredients
16261569|NCT00925977|Drug|insulin Glargine + Insulin Apidra|12 wees treatment with Insulin Glargine + Insulin Apidra
16261570|NCT00925977|Drug|Insulin NPH + Insulin Apidra: Active Comparator|Insulin NPH + Insulin Apidra: Active Comparator
16261571|NCT00925951|Device|Wet Cupping|Wet cupping (Seongho trade & company, Korea) will be practiced at two selected points (among the 6 acupoints, left or right BL23, BL24, BL25)
16261572|NCT00925951|Drug|Acetaminophen|Acetaminophen 500 mg tablets will be offered to both of the wet cupping group and waiting group for relieving severe pain.
16261573|NCT00925938|Drug|misoprostol|One vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg.
16261574|NCT00925938|Drug|placebo|placebo
16261575|NCT00925925|Other|Cord blood collection for analysis|Cord blood will be collected from the placentas at delivery for analysis
16261576|NCT00925912|Procedure|spinal block|0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
16261577|NCT00925912|Procedure|Perianal block|0.25% bupivacaine injected at perianal region
16261578|NCT00925899|Drug|Melatonin|20 mg melatonin orally every evening about 1 hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of melatonin followed by one week of placebo, or the other way around), the participant may receive melatonin for 6 weeks.
16261579|NCT00925899|Drug|Placebo|Placebo tablet orally every evening about one hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of placebo followed by one week of melatonin, or the other way around), the participant may receive melatonin for 6 weeks.
16261580|NCT00925886|Procedure|Acrysof Toric one-piece intraocular lens|Cataract Surgery with a intraocular lens implantation
16261581|NCT00925873|Drug|Active comparator (no fludarabine)|"Ara-C (100 mg/m2/d by continuous IV infusion 7 days), idarubicin (8 mg/m2/d (IV) for 5 days), GM-CSF a dose of 5 mg/kg/d on day 1. (Novartis Laboratory, Rueil-Malmaison, France).
~The consolidation course: intermediate-dose Ara-C (1g/m2 g 3-hour infusion twice a day 1 through 3) and idarubicin (10 mg/m2 on days 4 through 5). In the allocated arm
~Maintenance therapy for one year with 6-thioguanine (100 mg/m2/d orally on days 1 through 4 every week, Ara-C (60 mg/m2 SC on day 5 weekly) interrupted every 3 months with a reinduction course including CCNU (40 mg orally on day 1), mitoguazone (350 mg/m2 on day 1) and Ara-C (40 mg/m2 sc twice daily day 1 to 5)"
16261582|NCT00925873|Drug|Experimental (fludarabine)|"The same regimen with addition of fludarabine in every treatment sequence
~Induction course: Fludarabine (20 mg/m2/d, IV for 30 minutes) was started in the assigned group on day 2 and continued until the end of cytarabine treatment on day 7.
~Consolidation course: In the allocated arm, fludarabine (20 mg/m2/d, IV) was administered on days 2 through 3, 4 hours prior to cytarabine infusion.
~Reinduction courses: Ara-C associated in the allocated group with fludarabine (20 mg/m2/d, IV) on days 1 through 2."
16261583|NCT00925860|Procedure|non positive pressure mechanical ventilatory support|
16261584|NCT00925847|Drug|lithium|lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)
16261585|NCT00925834|Behavioral|Verbal suggestions|Verbal suggestions of a vasodilatory effect on cardiac vessels
16261586|NCT00925821|Procedure|allogeneic stem cell transplant versus second autologous transplantation|Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²
16261589|NCT00925795|Other|consumption 1. EVOO; 2. ROO|EVOO in doses of 50 mL/daily for 20 days; 14 days of wash-out period without olives and olive oil; followed by ROO in doses of 50 mL/daily for 20 days
16261590|NCT00925795|Other|consumption 1. ROO; 2. EVOO|ROO in doses of 50 mL/daily for 20 days; 14 days of wash-out period without olives and olive oil; followed by EVOO in doses of 50 mL/daily for 20 days
16261591|NCT00925782|Drug|Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection|Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.
16261592|NCT00925782|Drug|Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)|Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.
16261593|NCT00925769|Drug|bevacizumab [Avastin]|Escalating doses of 5/10mg/kg q2w
16261594|NCT00925769|Drug|capecitabine [Xeloda]|Escalating doses of 500/650/750/900mg/m2 bid
16261595|NCT00925769|Drug|erlotinib [Tarceva]|Escalating doses of 100/150mg daily
16261596|NCT00925756|Drug|Maraviroc|Maraviroc will be given dose-adjusted to background HIV treatment (150 mg, 300 mg, or 600 mg twice daily)
16261597|NCT00925743|Drug|cabazitaxel (XRP6258)|"administered by IV infusion
~in addition to cisplatin treatment"
16261598|NCT00925730|Drug|Pimecrolimus|
16261599|NCT00925704|Drug|Calcitriol|Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
16261600|NCT00925704|Drug|Lanthanum carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
16261601|NCT00925704|Drug|Sevelamer carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
16261602|NCT00925691|Device|RV lead|The RV lead is implanted at the apex or at the interventricular septum
16261603|NCT00925678|Drug|DSP-3025|
16261604|NCT00925678|Drug|Placebo|
16261605|NCT00925665|Device|Glidescope|Patients are to be intubated using the Glidescope technique
16261606|NCT00925665|Device|Macintosh laryngoscope|Patients are to be intubated using direct laryngoscopy with a Macintosh laryngoscope
16261607|NCT00925652|Drug|Bevacizumab|Given intravenously once every 3 weeks for approximately 6 months, then every 6 weeks for additional 1.5 years.
16261608|NCT00925652|Drug|Cyclophosphamide|Taken orally once a day for approximately 6 months.
16261609|NCT00925652|Drug|Methotrexate|One pill orally twice a day on days 1 and 2 of each week for approximately 6 months.
16261610|NCT00925652|Behavioral|Diet Intervention|Series of 13 telephone calls over the course of one-year with a dedicated and trained counselor
16261611|NCT00925652|Behavioral|Diet and Exercise Intervention|Counseling targeted toward increasing physical activity and a series of 13 telephone calls over the course of one-year with a dedicated and trained counselor.
16261612|NCT00925639|Drug|Isoflavone|150 mg of concentrated extract of soy containing 60 mg of isoflavone comprising 40 mg of genistein, 14,55 mg of daidizein, 3,02 mg of daidzine, 1,14 mg of glicitine, 0,91 mg genistine and 0,38 mg of glicetein.
16261613|NCT00925639|Drug|Placebo|Starch pill
16261614|NCT00925626|Procedure|Sub-Vastus arthrotomy|Sub-vastus arthrotomy
16261615|NCT00925626|Procedure|Mid - Vastus arthrotomy|Mid-vastus arthrotomy
16261616|NCT00925613|Device|LMA Proseal|"Once surgery is completed, the patient is transferred onto a gurney. Train of four is checked. Patient is ventilated with 100% oxygen. Remifentanil 0.5 ug/ml IV is administered. 30 seconds to 1 minute later, secretions are suctioned. Depth of anesthesia is ensured by deflating, inflating, then deflating the tracheal balloon of the DLT and checking for absence of movement, swallowing, or coughing. The DLT is removed, then the LMA proseal is inserted. Respiratory and hemodynamics parameters are noted. Tolerance of the exchange (presence of cough, movement, laryngospasm, desaturation) is noted. Inhalational gas is stopped. Reversal agent is administered if appropriate. Spontaneous breathing is titrated for <12 with boluses of fentanyl 25ug or sufentanil 2.5ug q 5mins.
~If failure to insert Proseal occurs, a second attempt is made after deepening anesthesia with propofol 1mg/kg and remifentanil 0.5ug/kg IV. If failure occurs again, the patient is intubated with a tracheal tube."
16261617|NCT00925613|Device|Tracheal tube|Once surgery is completed, the patient is transferred onto a gurney. Train of four is checked. Patient is ventilated with 100% oxygen. Remifentanil 0.5 ug/ml IV is administered. 30 seconds to 1 minute later, secretions are suctioned. Depth of anesthesia is ensured by deflating, inflating, then deflating the tracheal balloon of the DLT and checking for absence of movement, swallowing, or coughing. The DLT is removed, then a tracheal tube (size 7 for women, size 8 for men) is inserted. Respiratory and hemodynamics parameters are noted. Tolerance of the exchange (presence of cough, movement, laryngospasm, desaturation) is noted. Inhalational gas is stopped. Reversal agent is administered if appropriate. Spontaneous breathing is titrated for <12 with boluses of fentanyl 25ug or sufentanil 2.5ug q 5mins.
16261618|NCT00925600|Biological|Denosumab|Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
16261619|NCT00925600|Biological|Placebo|Prefilled syringe for subcutaneous (SC) injection
16261620|NCT00925587|Drug|darbepoetin alfa|Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
16261621|NCT00925574|Drug|CNTO 1959; Placebo|
16261622|NCT00925548|Biological|Tecemotide (L-BLP25) and Hormonal Treatment|"Investigational Arm:
~Pretreatment (Single Dose) 300 mg/m^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).
~Primary treatment phase:
~Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* (Week 1 to 8).
~Maintenance treatment phase:
~Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).
~*calculated as mass of lipopeptide (antigen)"
16261623|NCT00925548|Biological|Placebo of tecemotide (L-BLP25) and Hormonal Treatment|"Control Arm:
~Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.
~Primary treatment phase:
~Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).
~Maintenance treatment phase:
~Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD)."
16261624|NCT00925548|Drug|cyclophosphamide|300 mg/m^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.
16261625|NCT00925548|Drug|sodium chloride (NaCl)|NaCl 9 g/L infusion
16261626|NCT00925535|Drug|Lersivirine|1000 mg once daily for 10 days
16261627|NCT00925535|Drug|Rifabutin|300 mg once daily for 10 days
16261628|NCT00925535|Drug|Lersivirine|1000 mg once daily for 10 days
16261629|NCT00925535|Drug|Rifabutin|300 mg once daily for 10 days
16261630|NCT00925522|Device|Therapy Cool Path Duo Cardiac Ablation System|"Cardiac Ablation Procedure for Ischemic VT using a flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
~1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode."
16261631|NCT00925509|Procedure|Therapeutic assessment -Radio-surgical guidance.|"The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide.
~Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole.
~Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed.
~A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement."
16261632|NCT00925483|Procedure|dialysis|different dialysis schedules for each arm
16261633|NCT00925457|Other|No Intervention|Neither current domperidone nor current PPI
16261634|NCT00925457|Drug|Current Domperidone|Current domperidone at any dose, regardless of proton pump inhibitor status
16261635|NCT00925457|Drug|Current proton pump inhibitor (PPI)|Current PPI and not current dapoxetine
16261636|NCT00925444|Device|FOREseal|a pair of alginate sleeves for linear cutting staplers used in lung surgery
16261637|NCT00925444|Device|Stapling|Stapling alon or associated with sealants
16261638|NCT00925431|Behavioral|Lifestyle Modification|16 hours of motivational, lifestyle management session, 8 hours nutritional education.
16261639|NCT00925431|Behavioral|Supportive education|16 hours general fibromyalgia education, 8 hours of nutritional education
16261640|NCT00925418|Procedure|Frozen Glove|Using frozen glove during chemotherapy with Taxotere®
16261641|NCT00925405|Procedure|Breast MRI|Magnetic resonance imaging (MRI) scans of the breasts once per year
16261642|NCT00925405|Procedure|Mammogram|Breast x-ray used to detect breast cancer and look for abnormalities in the breast.
16261643|NCT00925392|Drug|Doripenem|Intravenous 500 mg every (q) 8 hours for 3 doses
16261644|NCT00925392|Drug|Doripenem|Intravenous 1000 mg q 8 hours for 3 doses
16261645|NCT00925366|Other|Imaging Procedure|CT Arthroscopy of the Shoulder - MR Arthroscopy of the Shoulder - MR of the shoulder
16261646|NCT00925353|Drug|4% lidocaine gel|1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water
16261647|NCT00925340|Behavioral|Family Check Up|The Family Check-Up provides a thorough assessment of individual family strengths and weaknesses and utilizes principles of motivational interviewing to encourage families to change.
16261648|NCT00925340|Behavioral|Psychoeducation|Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.
16261649|NCT00925327|Other|Corneal collagen cross-linking with riboflavin/UVA light|Corneal collagen cross-linking with riboflavin/UVA light
16261650|NCT00925314|Biological|CB-10-01 (Transgenic Lymphocyte Immunization)|1 Primary Infusion and 2 Booster Infusions
16261651|NCT00925301|Drug|migalastat hydrochloride|Oral capsule QOD
16261652|NCT00925301|Drug|Placebo|Oral capsule QOD
16261653|NCT00925288|Biological|Gardasil|Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
16261654|NCT00925275|Drug|I-131-CLR1404|Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0
16261655|NCT00925262|Behavioral|Cognitive Processing Therapy|an adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure
16261656|NCT00925262|Behavioral|Behavioral Activation|form of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity
16261657|NCT00925262|Behavioral|nonspecific counseling|nonspecific counseling interventions useful for a broad range of mental health and psychosocial problems.
16261658|NCT00925210|Procedure|Sequential pEBUS - ENB|"Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected.
~If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected."
16261659|NCT00925197|Other|INR self-testing program|
16261660|NCT00925171|Behavioral|Pulmonary Intervention|Maintenance programme of 2 hours duration, every 3 months. During the first hour patients will describe the extent to which they have been able to continue with their exercises at home on an individual basis and ways of enhancing adherence to this training will be discussed. Positive re-enforcement will be provided. Patients with suspected depression or social isolation will be referred to their GP for additional management. Patients will be advised on dyspnoea management strategies, especially controlled breathing combined with supervised activity exertion on activities relevant to their daily living. This will be followed by 1 hour of supervised strength and endurance training including walking, cycling, standing from sitting, arm exercises using dumbbells and step-ups. Patients will receive a written report on their progress by their physician and copied to their GP. This will be in addition to the standard advice given to the control group.
16261661|NCT00925158|Procedure|Dissector Assisted Malar Elevation|Malar dissector - Surgical instrument for video endoscopic rhytidoplasty.
16261662|NCT00925145|Procedure|Single Incision Laparoscopic Appendectomy|
16261663|NCT00925132|Drug|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.
~Decitabine - 6 cohorts with dose escalation.
~Panobinostat - 6 cohorts with dose escalation."
16261664|NCT00925119|Drug|Atenolol|12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated
16261665|NCT00925106|Drug|Celebrex capsule|Single dose 200 mg commercial Celebrex capsule
16261666|NCT00925106|Drug|Test formulation D1|Single dose 150 mg celecoxib as formulation D1
16261667|NCT00925106|Drug|Test formulation D2|Single dose 150 mg celecoxib as formulation D2
16261668|NCT00925106|Drug|Test formulation D3|Single dose 150 mg celecoxib as formulation D3
16261669|NCT00925093|Drug|Vancomycin|Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
16261670|NCT00925093|Drug|Teicoplanin|Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample
16261671|NCT00925093|Drug|Linezolid|Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample
16261672|NCT00925080|Device|IVBG|Venous blood glucose measurement every 7.5 minutes for 72-hours
16261673|NCT00925067|Procedure|laparoscopic (TEP) inguinal hernia repair|laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)
16261674|NCT00925067|Device|lightweight TiMesh|
16261675|NCT00925067|Device|lightweight VyproII|
16261676|NCT00925067|Device|Heavyweight Marlex|
16261677|NCT00925054|Drug|rAvPAL-PEG 0.001 mg/kg|In Part 1, the planned starting dose levels is 0.001 mg/kg
16261678|NCT00925054|Drug|rAvPAL-PEG 0.003 mg/kg|In Part 1, the planned starting dose levels is 0.003 mg/kg
16261679|NCT00925054|Drug|rAvPAL-PEG 0.01 mg/kg|In Part 1, the planned starting dose levels is 0.01 mg/kg
16261680|NCT00925054|Drug|rAvPAL-PEG 0.03 mg/kg|In Part 1, the planned starting dose levels is 0.03 mg/kg
16261681|NCT00925054|Drug|rAvPAL-PEG 0.1 mg/kg|In Part 1, the planned starting dose levels is 0.1 mg/kg
16261682|NCT00925041|Device|Vedera KXS|one treatment with the Vedera KXS
16261683|NCT00925028|Drug|Warfarin|Patients of group A will have the task of managing their own warfarin therapy using the provided nomograms. In the second office visit patients will be told to which group they were randomized and if they are in group A they will then be instructed on how to use the warfarin adjustment nomograms provided. After four months the groups will switch to the alternate management strategy. Patients in both groups will use warfarin tablets of two dosage strengths, 1 mg and 5 mg. All INR testing will be done at the community laboratory and results will be made available to the patient for dosage adjustment, as well as the physician. The physician's office will be available for appointments and phone calls from study subjects to discuss and support the process at any time.
16261684|NCT00925028|Drug|Warfarin|Patients of group B will continue to be managed by their physician. This time those in group B will be instructed on how to use the nomograms during an office visit. Patients in both groups will use warfarin tablets of two dosage strengths, 1 mg and 5 mg. All INR testing will be done at the community laboratory and results will be made available to the patient for dosage adjustment, as well as the physician. The physician's office will be available for appointments and phone calls from study subjects to discuss and support the process at any time.
16261685|NCT00925015|Biological|Dalotuzumab 10 mg/kg|Dalotuzumab at 10 mg/kg was intravenously administered once weekly
16261686|NCT00925015|Biological|Cetuximab|Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2, followed by subsequent once weekly intravenous infusions of 250 mg/m^2
16261687|NCT00925015|Drug|Irinotecan|Irinotecan was administered with an intravenous infusion of 150 mg/m^2, once every other week for 42 days
16261688|NCT00925015|Biological|Dalotuzumab 15/7.5 mg/kg|Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg
16261689|NCT00925002|Drug|Tafamidis|20 mg oral Fx-1006A daily
16261690|NCT00924989|Drug|OSI-906|Administered orally
16261691|NCT00924989|Other|Placebo|Matching placebo administered orally
16261692|NCT00924976|Behavioral|Steps for Achieving Financial Empowerment (SAFE)|The SAFE is a brief, 5-component intervention that aims to facilitate a cooperative consumer-payee relationship, increase accurate knowledge about representative payeeship, promote collaborative money management and effective budgeting, and prepare mutually developed plans for carrying out the payeeship in the future.
16261693|NCT00924963|Device|J-Tip jet injector|0.2ml 1%buffered lidocaine delivered by jet injector
16261694|NCT00924963|Device|Jet injection saline|0.2ml saline delivered via J-Tip jet injection
16261695|NCT00924963|Drug|lidocaine cream|4% lidocaine cream applied for 30 minutes to the skin
16261696|NCT00924950|Drug|Taclonex Ointment and Hydrogel Patch|Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.
16261697|NCT00924950|Drug|Taclonex Ointment|Taclonex ointment daily for one psoriatic plaque.
16261698|NCT00924937|Behavioral|Mediterranean Diet|Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
16261699|NCT00924937|Behavioral|Low Fat Diet|Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
16261700|NCT00924924|Behavioral|Act Healthy!|Six-week class of 50 minute sessions of self-management training for health behaviors
16261701|NCT00924924|Behavioral|Delayed treatment control|Delayed self-management training group - begins following completion of the experimental group training
16261702|NCT00924911|Drug|GSK1322322|Four different formulations of 1000mg of GSK1322322
16261703|NCT00924911|Drug|GSK1322322|GSK1322322 1000mg
16261704|NCT00924898|Drug|efavirenz, emtricitabine, and tenofovir|Once daily ART with emtricitabine, tenofovir DF and efavirenz
16261705|NCT00924885|Device|Swemed Follicle Aspiration Set Reduced Single Lumen|Thin tip to penetrate the tissue
16261706|NCT00924885|Device|Swemed Follicle Aspiration Set Single Lumen (1.4 mm)|Standard (1.4 mm) needle to penetrate the tissue
16261707|NCT00924872|Other|wheelchair skills training|Five 30-minute training sessions, at a target frequency of 3-5 sessions per week, aimed at improving their power wheelchair skills.
16261870|NCT00923533|Drug|Fimasartan|Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)
16261708|NCT00924859|Other|ELISA Test|assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test
16261709|NCT00924846|Procedure|High frequency oscillatory ventilation|Mechanical ventilation as high frequency oscillatory ventilation for 8h periods
16261710|NCT00924833|Drug|placebo|placebo tablet BID
16261711|NCT00924833|Drug|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
16261712|NCT00924833|Drug|Nebivolol|nebivolol 5 mg tablets. One nebivolol tablet daily. One placebo tablet daily.
16261713|NCT00924820|Drug|Bevacizumab|10 mg/kg by vein over about 1 hour, every 2 weeks.
16261714|NCT00924807|Drug|Leuprolide acetate, Bicalutamide, Sorafenib|Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
16261715|NCT00924794|Procedure|Cancer Registry of Norway (database)|Review of database to identify women with primary conization presenting with high grade lesions/ microinvasive cervical carcinomas. Recurrent cones with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer will be identified for all women with primary cones.
16261716|NCT00924781|Drug|MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline|MK2578 was to be administered intravenously (IV). Participants in Cohort 1 were to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to every week (QW) or once every 4 weeks (QM) dosing schedules within each cohort.
16261717|NCT00924781|Drug|MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline|MK2578 was to be administered IV. Participants in Cohort 2 were to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.
16261718|NCT00924781|Drug|MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline|MK2578 was to be administered IV. Participants in Cohort 3 were to receive 1 mcg of MK2578 for every 200 U of Epogen (epoetin alfa) received per week at Baseline. Participants were to be randomized to QW or QM dosing schedules within each cohort.
16261719|NCT00924768|Biological|20K EU CCRE|Inhalation of CCRE
16261720|NCT00924755|Device|Biomerix Revive™ (surgical mesh for inguinal hernia repair)|Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
16261721|NCT00924742|Drug|Tapimycin (piperacillin 4 g + tazobactam 0.5g)|One intravenous infusion (piperacillin 4 g + tazobactam 0.5 g powder for injection) over 30 minutes/single dosing
16261722|NCT00924729|Drug|Moxifloxacin 0.5% ophthalmic solution|Administer moxifloxacin study drug prior to cataract surgery.
16261723|NCT00924729|Drug|Besifloxacin 0.6% ophthalmic suspension|Administer besifloxacin study drug prior to cataract surgery.
16261724|NCT00924703|Drug|rAvPAL-PEG|The doses are planned to be in the same range as those tested in PAL-002 or PAL-004 and then modified either by increasing or decreasing the dose, adhering to an upper limit up to 5.0 mg/kg per week or 375 mg/week, considering each subject's individual responses related to safety and efficacy.
16261725|NCT00924690|Other|Behavioral Messages|Participants will read 10 behavioral messages about colon cancer screening and physical activity.
16261726|NCT00924690|Other|Generic Messages|Individuals will read 10 generic messages about colon cancer screening and physical activity.
16261727|NCT00924677|Procedure|radiofrequency neurotomy for genicular nerve|RF cannula was advanced percutaneously towards areas connecting the shaft to epicondyle of femur or tibia. Lidocaine (1 mL of 2%) was injected before activation of the RF generator (NeuroThermTM, Morgan automation LTD, Liss, UK). RF electrode was inserted through RF cannula. The temperature of the electrode tip was raised to 70℃ for 90 seconds by radiofrequency generator.
16261728|NCT00924677|Procedure|radiofrequency neurotomy sham therapy|The placebo (sham) group received the same procedure without activation of the RF generator.
16261729|NCT00924664|Biological|Tanezumab 20 mg|Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
16261730|NCT00924664|Biological|Tanezumab 10 mg|Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
16261731|NCT00924651|Behavioral|exercise|home based walking and progressive resistance training exercise
16261732|NCT00924638|Device|Reveal® XT Insertable Cardiac Monitor|The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
16261733|NCT00924625|Other|Neuromuscular electrical stimulation|Strength of the quadriceps muscles will be tested at the beginning of each session. During administration of the NMES participant will sit with the knees bent at 70 degrees. The force sensing pad will be secured to the ankle joint. Two electrodes will be placed on the thigh muscle; one near the hip and the other near the knee joint. The intensity of NMES will be increased gradually according with tolerance. During each treatment 15 electrically elicited muscle contractions will be administered to each thigh. Each contraction will last 14 sec followed by 1min rest.
16261734|NCT00924625|Other|Volitional exercises|The training will include bilateral exercises using resistance equipment (Leg Extension and Leg Press machines). Each resistance exercise will have: (a) dynamic muscle action at moderate repetition velocity (1-2 s concentric, 1-2 s eccentric, 2-3 s interval); (b) 3 sets of 8 repetitions with a load corresponding to 80% of one repetition maximum(1-RM); (c) 2-min rest period between sets and exercises.
16261735|NCT00924612|Drug|Oral testosterone undecanoate (containing 300 mg T)|
16261736|NCT00924599|Behavioral|Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)|Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
16261737|NCT00924599|Behavioral|Lifestyle education (English & Spanish)|The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
16261738|NCT00924586|Drug|ONO-1101|Placebo for one minute IV
16261739|NCT00924586|Drug|ONO-1101|0.125 mg/kg for one minute IV
16261740|NCT00924573|Drug|Metformin|oral administration
16261741|NCT00924573|Drug|placebo|oral administration
16261742|NCT00924573|Drug|Glimepiride (HOE490)|oral administration
16263619|NCT00910156|Device|Macintosh laryngoscope|Macintosh intubation
16261743|NCT00924560|Drug|91-day Levonorgestrel Oral Contraceptive|"Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
~Take 1 tablet daily"
16261744|NCT00924560|Drug|28-day Levonorgestrel Oral Contraceptive|Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
16261745|NCT00924547|Dietary Supplement|Docosahexanoic Acid Supplement|"The active treatment will consist of Martek's chewable DHA capsules containing 200mg in each capsule. The treatment will be provided as approximately 25mg/kg/day and 35mg/kg/day.
~These dosages will be divided BID-TID and will be given for 4 weeks."
16261746|NCT00924547|Dietary Supplement|Placebo|Placebo identical to active treatment.
16261747|NCT00924534|Drug|Placebo|Placebo
16261748|NCT00924534|Drug|SLV337|SLV337 400 mg/day
16261749|NCT00924534|Drug|SLV337|SLV337 800 mg/day
16261750|NCT00924534|Drug|SLV337|SLV337 1400 mg/day
16261751|NCT00924521|Dietary Supplement|Whole grain diet|Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment.
16261752|NCT00924521|Dietary Supplement|Refined grain|Participants in this group will receive only refined grains as typically consumed in the average American diet.
16261753|NCT00924508|Device|hydrogel patch|occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.
16261754|NCT00924508|Drug|Triamcinolone (TAC) 0.1% cream|Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.
16261755|NCT00924495|Device|transcranial magnetic stimulation|rTMS therapy daily for two weeks, five times per week each lasting for half an hour
16261756|NCT00924482|Device|Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery|Measure cardiac output during perioperative period and compare to pulmonary artery thermodilution cardiac output measurements.
16261757|NCT00924469|Drug|Abiraterone|Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day at least 1 hour before a meal or 2 hours after a meal for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.
16261758|NCT00924469|Drug|Leuprolide|Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks in Group 1 and Group 2.
16261759|NCT00924469|Drug|Prednisone|Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.
16261760|NCT00924456|Behavioral|Transcendental Meditation program|a natural effortless mental technique
16261761|NCT00924443|Drug|clofarabine|
16261762|NCT00924430|Drug|Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin|Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
16261763|NCT00924430|Drug|Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin|Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
16261764|NCT00924417|Behavioral|Routine Care|Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
16261765|NCT00924417|Behavioral|Distraction|"Parent given brief information about the cognitive behavioral technique known as distraction. Parent and child then given 3 distraction toys/tools to assist with peripheral intravenous line placement."
16261766|NCT00924404|Drug|Xylitol|5% solution for sinus rinse
16261767|NCT00924404|Drug|Saline|saline for sinus rinse
16261768|NCT00924391|Dietary Supplement|phytosterol enhanced soy based beverage|
16261769|NCT00924391|Dietary Supplement|1% milk|
16261770|NCT00924352|Drug|Dasatinib|Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
16261771|NCT00924352|Drug|Ixabepilone|Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
16261772|NCT00924339|Dietary Supplement|soy protein diet|Intervention-Group (n = 15): Fat- modified dietary regime and a minimum amount of soy protein: 0,25 g/ kg BW/d
16261773|NCT00924339|Dietary Supplement|rapeseed oil|Control-Group (n = 15): Diet reduced in SFA, modified in fatty acid pattern. Only rapeseed oil should to be used for preparation of the meals (baking, frying, in salad, and as spread.
16261774|NCT00924326|Drug|Fludarabine|Days -5 to -1 (after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes
16261775|NCT00924326|Drug|Cyclophosphamide|Days -5 to -4: 60mg/kg intravenous (IV) over 60 minutes
16261776|NCT00924326|Biological|Anti-cluster of differentiation 19 (CD19)-CAR PBL|"Anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) peripheral blood lymphocytes ( PBL).
~Day 0 (two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes."
16261777|NCT00924326|Drug|Aldesleukin|Day 0: 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
16261778|NCT00924326|Drug|Fludarabine|Days -5 to -3 (after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes
16261779|NCT00924326|Drug|Cyclophosphamide|Days -5 to -3: 300mg/m^2 intravenous (IV) over 60 minutes
16261780|NCT00924313|Drug|(C-11 Acetate)|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
16261781|NCT00924287|Drug|in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin|720,000 IU/kg every 8 hours for a maximum of 15 doses
16261871|NCT00923533|Drug|Hydrochlorothiazide|Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)
16261782|NCT00924287|Drug|Cyclophosphamide|60 mg/kg/day x 2 days intravenously (IV) in 250 ml 5% dextrose in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour
16261783|NCT00924287|Drug|Fludarabine|25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16261784|NCT00924287|Drug|Mesna|3 mg/kg/hour intravenously diluted in a suitable diluent over 23 hours after each cyclophosphamide dose.
16261785|NCT00924274|Dietary Supplement|rapeseed oil|rapeseed oil in amounts between 14 and 27 g
16261786|NCT00924274|Dietary Supplement|sunflower oil|sunflower oil
16261787|NCT00924261|Other|Hip Stretch|Hip flexor stretch daily for 3 min x 10 weeks
16261788|NCT00924261|Other|Shoulder Stretch|Shoulder Adduction stretch - 3 minutes, daily, for 10 weeks
16261789|NCT00924248|Drug|Gadoxetic acid disodium (Primovist, BAY86-4873)|Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.
16261790|NCT00924222|Drug|Sevoflurane|Sedation with sevoflurane
16261791|NCT00924222|Drug|Propofol|Sedation on intensive care unit with propofol
16261792|NCT00924209|Drug|Gemcitabine|1250 mg/m^2 dose for two doses on days 1 and 8
16261793|NCT00924209|Drug|Cisplatin|80 mg/m^2 on day 1
16261794|NCT00924209|Drug|Bevacizumab|7.5 mg/m^2 on day 1 every 21 days for first two cycles only
16261795|NCT00924209|Procedure|Surgery|thoracotomy with lobectomy/pneumonectomy and mediastinal lymph node dissection 4-6 weeks post completion of last cycle of cisplatin
16261796|NCT00924209|Drug|Etoposide|100 mg/m^2 intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles.
16261797|NCT00924183|Other|Treatment-as-usual|
16261798|NCT00924170|Drug|LMB-2|Begin with 30 mcg/Kg intravenous (IV) on days 3, 5 and 7. Escalate to 40 mcg/Kg if dose limiting toxicity (DLT) in 0/3 or 1/6 at 30 mcg/Kg. Continue at 40 mcg/Kg if 0-1 of 6 have DLT at 40 mcg/Kg.
16261799|NCT00924170|Drug|Fludarabine|"Days 1-3:
~Patients 1-7, 10-14, and >18:25mg/m^2/day Patients 8 - 9:30 mg/m^2/day Patients 15- 17:20 mg/m^2/day"
16261800|NCT00924170|Drug|Cyclophosphamide|"Days 1-3:
~Patients 1-7, 10 -14, and >18:250 mg/m^2/day Patients 8 - 9:300 mg/m^2/day Patients 15-17:200 mg/m^2/day"
16261801|NCT00924157|Dietary Supplement|IPP|Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
16261802|NCT00924157|Other|Placebo|Matching placebo capsules
16261803|NCT00924118|Drug|Sodium Nitrite|Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.
16261804|NCT00924105|Drug|CYT013-IL1bQb|s.c. injection
16261805|NCT00924105|Drug|Placebo|s.c. injection
16261806|NCT00924092|Biological|GI-6207 [Recombinant Saccharomyces Cerevisia|
16261807|NCT00924092|Drug|(Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])|
16261808|NCT00924079|Drug|nalbuphine|oral dosage form, 66 mg, single dose
16261809|NCT00924066|Drug|Ixempra (Ixabepilone (BMS-247550) )|Participants received Ixabepilone 6mg/m^2 for a total of 30mg/m^2 inpatient or outpatient intravenously over an hour on the first five days of each 21 day cycle.
16261810|NCT00924053|Drug|EGT0001474|Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.
16261811|NCT00924053|Drug|Placebo|Placebo capsules to match EGT0001474
16261812|NCT00924040|Drug|BL22 (CAT-3888)|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
16261814|NCT00924014|Drug|Conivaptan|Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr
16261815|NCT00924014|Drug|Furosemide|Furosemide will be given IV at the subjects usual oral dose up to 80 mg. If the dose is 80 mg or more only 1/2 the dose will be given IV.
16261816|NCT00924014|Drug|Conivaptan and furosemide|Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours
16261817|NCT00924001|Drug|DMF5 Melanoma Reactive TIL|given intravenously over 20-30 minutes (between 1 x 10^9 and 1 x 10^11 lymphocytes) after expansion in interleukin-2 and OKT-3
16261818|NCT00924001|Drug|Cyclophosphamide|60 mg/kg/day x 2 days intravenously
16261819|NCT00924001|Drug|Fludarabine|25 mg/m^2/day intravenously x 5 days
16261820|NCT00924001|Drug|Aldesleukin|720,000 IU/kg/dose intravenously every 8 hours for up to 15 doses
16261821|NCT00923988|Other|secondhand smoke exposure|Participants will be exposed to secondhand smoke for one hour. As a measure of secondhand smoke exposition, room carbon monoxide concentration will be continuously measured using an Ambient Carbon Monoxide Monitor APMA-360 and kept constant between 4.5-6.0 ppm. Levels in this magnitude are typically seen in smoking areas of restaurants and bars.
16261822|NCT00923975|Device|DIDGET World Web Community Reports|During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.
16261823|NCT00923962|Drug|Glucagon like peptide-1|0,1 pmol/kg/min
16261824|NCT00923962|Drug|Adenosine|20-40 microgram/minute
16261825|NCT00923949|Drug|Pioglitazone|45 mg tablet daily by mouth for six weeks
16261826|NCT00923936|Drug|Liposomal Doxorubicin|Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.
16261827|NCT00923936|Drug|Bevacizumab|Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.
16261828|NCT00923923|Behavioral|stress|compare levels of stress
16261829|NCT00923910|Drug|WT1 Peptide-Pulsed Dendritic Cells|
16261830|NCT00923910|Drug|Donor Lymphocytes|Lymphocytes from donors (related or unrelated) collected via lymphapheresis.
16261831|NCT00923910|Drug|IL-4|water-soluble protein; this study will use GMCSF (granulocyte macrophage colony stimulating factor)/IL-4 generated monocyte derived dendritic cells
16261832|NCT00923910|Drug|KLH|Neoantigen known to induce helper responses; will be used concurrently as a vaccine adjuvant and control antigen.
16261833|NCT00923910|Drug|WT1 Peptides|dendritic cell vaccine
16261834|NCT00923910|Drug|Endotoxin|Purified lipopolysaccharide prepared from E.Coli 0:113
16261835|NCT00923910|Drug|Diphenhydramine|Pre-medication
16261836|NCT00923910|Drug|Acetaminophen|Pre-medication
16261837|NCT00923897|Radiation|Palliative RT|Prior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes.
16261838|NCT00923871|Procedure|Cone Beam CT|Patients will also have a CBCT scan when they are having their first IMRT treatment.
16261839|NCT00923845|Drug|Pentostatin|Pentostatin: 2- 4mg/m^2(CrCL based dosing) intravenous (IV) on days 1, 8, and 15
16261840|NCT00923845|Drug|Sirolimus|Sirolimus: 4 mg by mouth (PO) on days -3 to +7 post-transplant (No Sirolimus administered after day 7 post-stem cell transplant (SCT))
16261841|NCT00923845|Drug|Cyclophosphamide|Cyclosporine: 2 mg/kg every 12 hours PO or IV starting on day -4 of hematopoietic stem cell transplant (HSCT)
16261842|NCT00923845|Procedure|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Allogeneic Hematopoietic Stem Cell Transplant
16261843|NCT00923845|Procedure|Th2 rapa cells|Th2 rapa cell Transplantation
16261844|NCT00923845|Procedure|Donor Lymphocyte Harvest|Apheresis
16261845|NCT00923845|Procedure|Induction Therapy|Pentostatin and cyclophosphamide (PC) conditioning regimen.
16261846|NCT00923845|Procedure|GVHD prophylaxis|Short course of sirolimus plus maintenance therapy with sirolimus A.
16261847|NCT00923845|Procedure|Donor Hematopoietic Stem Cell Harvest|Following lymphocyte harvest, donors for recipients will undergo stem cell mobilization and harvest.
16261848|NCT00923819|Procedure|Laparoscopic gastric bypass|Patients are referred to Morbid Obesity Center from Vestfold Hospital Trust and other hospitals in Norway. The procedure will take place at Morbid Obesity Center, Vestfold Hospital Trust.
16261849|NCT00923819|Behavioral|Standard conservative treatment|Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.
16261850|NCT00923806|Biological|PG13-CEA_TCR (Anti-CEA TCR PBL)|
16261851|NCT00923806|Drug|Aldesleukin|720,000 IU/kg intravenous over 15 minutes every 8 hours for up to 5 days
16261852|NCT00923793|Device|Titanium implant (CranioConstruct™)|One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.
16261853|NCT00923793|Device|Hydroxylapatite (CustomBone)|Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.
16261854|NCT00923741|Drug|Talactoferrin|
16261855|NCT00923741|Procedure|Apheresis|
16261856|NCT00923728|Drug|AVN944|
16261857|NCT00923702|Biological|Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)|The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180.
16261858|NCT00923676|Drug|fenofibrate|pill 145 mg, 145 mg/day, for 12 months
16261859|NCT00923676|Drug|Rosuvastatin|pills of 10 mg, 10 mg/day, 12 months
16261860|NCT00923676|Drug|fenofibrate + rosuvastatin|fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months
16261861|NCT00923663|Drug|Lenalidomide|25 mg Lenalidomide p.o. daily for 21 days
16261862|NCT00923637|Drug|Pemetrexed/Oxaliplatin|In the first cycle, patients received Pemetrexed 500 mg/m2 (i.v. infusion over 10 minutes) on day 1 of a 21-day cycle. From 2nd cycle, patients received pemetrexed 500 mg/m2 (i.v. infusion over 10 minutes) then oxaliplatin 120 mg/m2 (i.v. infusion over 120 minutes) on day 1 of a 21-day cycle. Study drug administration is to begin on d14 to d28 after R0 resection of the tumor. A total of three cycles is intended for patients with stage IB NSCLC, and four cycles for II-IIIA NSCLC, respectively.
16261863|NCT00923624|Other|attention control|9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.
16261864|NCT00923624|Behavioral|adherence intervention|9 messages tailored by the study nurse and guided by the IMB model
16261865|NCT00923611|Drug|Fimasartan|
16261866|NCT00923598|Drug|0.1% and 0.4% perineural ropivicaine|Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
16261867|NCT00923572|Drug|EE30/DRSP (Yasmin, BAY86-5131)|Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.
16261868|NCT00923559|Other|Treatment as Usual at Child Health Centre|Treatment as usual (TAU) involved scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers might be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the TAU framework, additional treatment might be initiated by the nurse or the mother. This was registered at the end-point interview.
16261869|NCT00923559|Other|Mother-Infant Psychoanalytic treatment (MIP)|MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. In the study, the analysts strived to recruit the baby for an emotional interchange, though this did not imply any belief that the infant would understand verbal communication. Rather, the analyst addressed the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst took care in enrolling the participant mother. This was to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety.
16263665|NCT00909831|Other|high performance liquid chromatography|
16261872|NCT00923520|Drug|DMS 612|DMS 612 on day 1 and 2 with doses starting at 3.5mg/m2 to 18.5mg/m2 every 21 days until MTD is reached
16261873|NCT00923494|Drug|20 ml of ropivacaine 0.5%|Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
16261874|NCT00923494|Drug|30 ml of ropivacaine 0.5%|Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
16261875|NCT00923494|Drug|40 ml of ropivacaine 0.5%|Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
16261876|NCT00923481|Drug|Fostamatinib disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
16261877|NCT00923429|Procedure|Stay-active care|No other treatment than the stay-active care
16261878|NCT00923429|Procedure|Stay-active care+stretching|Stay-active care and muscle stretching at home and during physiotherapist appointments
16261879|NCT00923429|Procedure|Stay-active+stretching+manual therapy|Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises
16261880|NCT00923429|Procedure|Stay-active+stretching+manual therapy+steroid injections|Manual therapy including steroid injection when indicated in addition to stay-active care and stretching during GP appointments (injections) and during GP or physiotherapist appointments (remaining treatment modalities)
16261881|NCT00923403|Dietary Supplement|plant sterol enriched soymilk|plant sterol enriched soymilk
16261882|NCT00923403|Dietary Supplement|control dairy milk|control dairy milk
16261883|NCT00923390|Genetic|2G-1 TCR Retroviral Vector-Transduced lyn|
16261884|NCT00923390|Drug|Aldesleukin|
16261885|NCT00923390|Drug|Cyclophosphamide|
16261886|NCT00923390|Drug|Fludarabine|
16261887|NCT00923390|Drug|(PG13-A(F/K-F-SGSG-T2a-B (opt) (2G-1 TCR) retroviral vector-transduced lymphocyte|
16261888|NCT00923364|Drug|Cyclophosphamide (CTX, Cytoxan)|14.5 mg/kg intravenous (IV) (in the vein) infusion over 30 minutes once daily on days -6 and -5 (weight based dosing) or 50 mg/kg IV infusion over 2 hours on day -6 (weight based dosing) or 50/kg IV once daily x 2 doses on days +3 and +4
16261889|NCT00923364|Drug|Fludarabine(Fludara,Berlex Laboratories)|40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
16261890|NCT00923364|Procedure|Total Body Irradiation (TBI)|200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)
16261891|NCT00923364|Procedure|Allogeneic Hematopoietic Stem Cell (HSC)|stem cell transplant
16261892|NCT00923364|Drug|Equine Anti-Thymocyte Globulin|30mg/kg IV (in the vein) once daily x 3 days on Days -6, -5, -4 (3 doses total)
16261893|NCT00923351|Drug|Tumor Purged/CD25 Depleted Lymphocytes|
16261894|NCT00923351|Biological|Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine|Tumor lysate/KLH pulsed dendritic cells (minimum of 1 X 10e6 cells/kg) on Day2.
16261895|NCT00923351|Drug|rhIL-7|rhIL-7 (20 mcg/kg/dose SQ) approx. 48 hours prior to vaccine) Day 0, Day 14, Day 28 and Day 42
16261896|NCT00923351|Biological|Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine|Tumor lysate/KLH Pulsed dendritic cell vaccine (1-5 X 10e7 cells/injection site, given in 3 sites intradermal) on Day 2, Day 16, Day 30, Day 44, Day 56, Day 70.
16261897|NCT00923338|Device|Surgisis Biodesign (Vesico-vaginal fistula plug)|Vesico-vaginal fistula plug
16261898|NCT00923312|Biological|CV9201|CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.
16261899|NCT00923299|Drug|cetuximab|Cetuximab at the initial dose of 400 mg/m² (J1S1) as a 2-hour infusion and then at the 250 mg/m² dose as a 1-hour infusion in subsequent weeks.
16261900|NCT00923299|Drug|trastuzumab|"Two dose levels of trastuzumab will be evaluated for Phase 1:
~Level 1: a loading dose of 3 mg/kg as a 90-minute intravenous infusion at J1S1 and then 1.5 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations;
~Level 2: a loading dose of 4 mg/kg as a 90-minute intravenous infusion at J1S1 and then 2 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations."
16261901|NCT00923273|Drug|FDG-PET|PET CT will be performed at baseline and after two cycles of treatment.
16261902|NCT00923273|Drug|Pemetrexed|
16261903|NCT00923273|Drug|Sirolimus|
16261904|NCT00923273|Dietary Supplement|Vitamin B12|1000 micrograms intramuscularly every 63 days administered the preceding first dose of pemetrexed
16261905|NCT00923273|Dietary Supplement|Folic acid tablets|1 mg dose every 63 days administered during the week preceding first dose of pemetrexed and will be continued for 21 days following last dose of pemetrexed.
16261906|NCT00923273|Drug|Dexamethasone tablets|4 mg dose twice daily the day before, the day of, and the day after pemetrexed.
16261907|NCT00923260|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.
16261908|NCT00923260|Procedure|Omentectomy|After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.
16261909|NCT00923247|Drug|Bortezomib|This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
16261910|NCT00923247|Drug|Vandetanib|This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults
16261911|NCT00923234|Drug|Azacitidine|75 mg/m² SC days 1-5 every 28 days for a maximum of 8 cycles
16261912|NCT00923234|Drug|Lenalidomide|10 - 25 mg PO days 6-19 every 28 days for a maximum of 8 cycles
16261913|NCT00923195|Drug|MART-1: 26-35(27L) Peptide|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14."
16261914|NCT00923195|Drug|Montanide ISA 51 VG|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14."
16261915|NCT00923195|Drug|gp100:154-162 Peptide|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14."
16261916|NCT00923195|Procedure|Radiation|2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute
16261917|NCT00923195|Drug|Aldesleukin|Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).
16261918|NCT00923195|Drug|Fludarabine|Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days
16261919|NCT00923195|Drug|Cyclophosphamide|Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days.
16261920|NCT00923195|Genetic|Anti-gp 100:154 TCR PBL|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
~One mg of either the gp100:154-162 or theMART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14"
16261921|NCT00923195|Genetic|Anti-MART-1 F5 TCR PBL|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).
~One mg of either the gp100:154-162 or theMART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14"
16261922|NCT00923182|Drug|alemtuzumab|
16261923|NCT00923169|Drug|Anti-Transforming Growth Factor-beta (GC 1008)|
16261924|NCT00923156|Drug|aliskiren|Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site
16261925|NCT00923156|Drug|ramipril|2.5 mg , 5.0 mg or 10 mg once daily
16261926|NCT00923156|Drug|Placebo to aliskiren|matching placebo to aliskiren in double blind phase
16261927|NCT00923156|Drug|Placebo to ramipril|Matching placebo to ramipril capsule in double blind phase
16261928|NCT00923130|Drug|Bevacizumab|Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.
16261929|NCT00923130|Drug|Ixabepilone|Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days.
16261930|NCT00923117|Drug|Sutent (sunitinib)|Oral dose 37.5 mg daily on a continuous 4 week cycle
16261931|NCT00923091|Drug|olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo|One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
16261932|NCT00923091|Drug|Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo|One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
16261933|NCT00923091|Drug|olmesartan medoxomil + amlodipine + hydroclororthiazide|One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
16261934|NCT00923091|Drug|olmesartan medoxomil + amlodipine + hydroclororthiazide|One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
16261935|NCT00923091|Drug|olmesartan medoxomil + amlodipine + hydroclororthiazide|One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
16261936|NCT00923091|Drug|olmesartan medoxomil + amlodipine|One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day
16261937|NCT00923091|Drug|olmesartan medoxomil + amlodipine|One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.
16261938|NCT00923091|Drug|olmesartan medoxomil + amlodipine|One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.
16261939|NCT00923078|Behavioral|Auditory Cognitive Training|The program entails six computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and adapt in difficulty to individual performance, giving constant feedback about progress. Each of the six exercises focuses on a distinct process: (1) auditory processing speed, (2) discriminating sounds, (3) sound precision, (4) sound sequencing, (5) working memory, and (6) narrative memory. Training was administered in a supervised clinical laboratory setting at a frequency of five 60-minute sessions per week over 4 weeks.
16261980|NCT00922701|Drug|L-carnitine|Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days.
16261981|NCT00922688|Drug|Dipeptide Alanyl-Glutamine|Intravenous supplementation of the dipeptide alanyl-glutamine is started 24 hours prior to surgery (dosage glutamine: 0,5 g/kg/day, and continued 24 hours postoperatively.
16261940|NCT00923078|Behavioral|Visual Cognitive Training|The program entails five computer-based exercises that are designed to be very easy to use and require no computer experience. The exercises are calibrated to individual performance at the onset of training and, following our laboratory procedures, calibration testing is repeated every 5th session. Exercises adapt in difficulty to individual performance, giving constant feedback about progress. Each of the five exercises focuses on a distinct process: (1) visual precision, (2) visual processing speed, (3) divided attention, (4) visual working memory, and (5) useful field of view. Training was administered in a supervised clinical laboratory setting at a frequency of five 40-minute sessions per week over 4 weeks.
16261941|NCT00923013|Drug|Cladribine|Cladribine 0.15 mg/Kg/day by 2-hour i.v. infusion days 1-5. The infusion time may be changed to 1 hour at the discretion of the PI.
16261942|NCT00923013|Drug|Rituximab|Rituximab 375 mg/m2 i.v. infusion every week x8, begin day 1 in half of randomized patients and in all HCLv patients, and then again in all patients at least 6 months later when HCL is detected by blood FACS.
16261943|NCT00923000|Drug|Nalbuphine|Nalbuphine 10mg with oral administration
16261944|NCT00923000|Drug|Morphine|Morphine 10mg with oral administration
16261945|NCT00923000|Drug|Morphine with Long dan xie gan tang|Morphine 10mg with oral administration
16261946|NCT00923000|Drug|Nalbuphine with Long dan xie gan tang|Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration
16261947|NCT00923000|Drug|Nubian with Long dan xie gan tang|Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration
16261948|NCT00922987|Drug|Lyrica (pregabalin)|The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)
16261949|NCT00922974|Radiation|External beam radiation therapy|Single fraction dose of 8 Gy external beam radiation therapy
16261950|NCT00922974|Radiation|Radiosurgery/SBRT|Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
16261951|NCT00922961|Biological|Blood sample|Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
16261952|NCT00922961|Procedure|Clinical exam|Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians
16261953|NCT00922948|Procedure|Cryoablation|Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
16261954|NCT00922948|Procedure|Radiofrequency ablation|Thermal injury is the predominant mechanism of action of RFA. A high-frequency alternating current emitted from the exposed noninsulated portion of the electrode generates frictional heat, agitating ions in the tissue surrounding the tip of the needle.
16261955|NCT00922935|Device|Cresco|Cresco components loading 10 days post surgery
16261956|NCT00922935|Device|Cresco|Cresco loading at 6-8 weeks post surgery
16261957|NCT00922935|Device|Straumann components|Straumann components loading 6-8 weeks post surgery
16261958|NCT00922909|Behavioral|Simon task|Reaction time task
16261959|NCT00922896|Drug|Gemcitabine, Cisplatin, Erlotinib (Tarceva)|"Erlotinib 100 mg po q d daily AND
~Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
~Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8
~Every 3 weeks"
16261960|NCT00922883|Drug|Eltrombopag|
16261961|NCT00922870|Device|Cascade|Cascade treatment over 48h
16261962|NCT00922870|Other|Standard treatment|Standard therapy
16261963|NCT00922857|Procedure|Respiratory rehabilitation|The training begins 5 days after the initial assessment. It consists of 3 weekly sessions for 8 consecutive weeks, including the following activities interspersed with periods of rest, according to the needs of patients
16261964|NCT00922844|Drug|Sevoflurane and isoflurane|Patients will be randomized to a 10 minute treatment with isoflurane, followed by a wash-out period, followed by a 10 minute treatment with sevoflurane, or the other way round.
16261965|NCT00922805|Dietary Supplement|guar gum|guar gum (20 g/l of formula) for one week
16261966|NCT00922792|Drug|activated recombinant human factor VII, long acting|Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
16261967|NCT00922792|Drug|activated recombinant human factor VII, long acting|Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours
16261968|NCT00922779|Drug|peginterferon alfa-2a [Pegasys]|180micrograms sc weekly for 12-48 weeks
16261969|NCT00922779|Drug|ribavirin|800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
16261970|NCT00922766|Drug|Dalteparin|Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
16261971|NCT00922753|Other|VS|Spontaneous breathing of 100% oxygen in a facemask for 3 minutes
16261972|NCT00922753|Other|AI-4/PEEP-4|Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes
16261973|NCT00922753|Other|AI-6/PEEP-4|Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.
16261974|NCT00922740|Drug|VA106483|Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
16261975|NCT00922740|Drug|Placebo|Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
16261976|NCT00922727|Biological|L. reuteri|The oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops.
16261977|NCT00922727|Biological|Sunflower Oil|As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops.
16261978|NCT00922714|Drug|Glutamine|Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
16261979|NCT00922714|Drug|saline (placebo)|NaCl 0.9 g/L
16262060|NCT00922012|Device|Electromagnetic Stimulation Therapy|Electromagnetic Stimulation Therapy for 24 weeks
16261982|NCT00922688|Drug|Placebo|Intravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively.
16261983|NCT00922688|Drug|Dipeptide Alanyl-Glutamine|Enteral supplementation of the dipeptide alanyl-glutamine is started 24 hours prior to surgery (dosage glutamine: 0,5 g/kg/day, and continued 24 hours postoperatively.
16261984|NCT00922675|Procedure|Postconditioning|After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting. In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
16261985|NCT00922675|Procedure|Control intervention|After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
16261986|NCT00922649|Device|Insulin Pump therapy|Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
16261987|NCT00922636|Drug|LY2216684|Taken in tablet form QD po.
16261988|NCT00922636|Drug|Methylphenidate|Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase.
16261989|NCT00922636|Drug|Placebo (tablet)|Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed by 2 weeks in the taper phase.
16261990|NCT00922636|Drug|Placebo (capsule)|Placebo given as a capsule for methylphenidate blind QD po for the 8-week double-blind treatment phase followed by 2 weeks in the taper phase.
16261991|NCT00922623|Device|Belotero®|Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer
16261992|NCT00922610|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks
16261993|NCT00922597|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.
16261994|NCT00922584|Drug|sorafenib (Nexavar)|oral sorafenib 400 mg, twice daily, until disease progression or unacceptable toxicity
16261995|NCT00922571|Procedure|FS Laser Surgery|The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
16261996|NCT00922571|Device|FS Laser System|The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
16261997|NCT00922558|Other|Evaluation of postural control|Children will be measured once using a Tetra-aximetric posturography method
16261998|NCT00922545|Other|Implementation of Clinical Practice Guidelines (GPC) and Health Education Program|Intervention: The program includes giving clinical results to the health care workers(doctor and nurse), from the medical records and interview. A training course (20h)that deals with aspects related to GPC, motivational interview and health education (tobacco, inhalers, alimentation, exercise and physiotherapy).
16261999|NCT00922532|Drug|Inhaled Nitric Oxide|Inhaled Nitric Oxide will be administered continuously starting at 20ppm through an INOvent delivery system for up to 14 days.
16262000|NCT00922532|Drug|Placebo|Nitrogen gas will be administered in the same manor as the experimental drug
16262001|NCT00922519|Other|18F-Sodium Fluoride (Na18F)|200-400 MBq/injection, up to 4 doses of Na18F will be permitted per patient as part of acceptable disease assessment.
16262002|NCT00922506|Drug|doxazosin plus tolterodine SR|doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
16262003|NCT00922493|Other|inspiratory muscle training|"Protocol of inspiratory muscle training using threshold IMT®: After the MIP was measured, inspiratory muscle training was initiated. The Threshold-IMT® device of a linear pressure load produces a resistance to inspiration through the use of a flow-independent one-way valve. During expiration there is no resistance because the unidirectional valve opens, while during inspiration the valve closes, becoming hard due to the resistance of the spring. The suggested protocol was: initial load of 30% of the M24, increasing daily by 10%, with training for five minutes, twice a day, seven times a week in the period from the beginning of the weaning from the MV until the extubation of the patient.
~An essential factor was the use of supplemental oxygen (O2) as needed by the patient. The patients were in DD with fowler 45º."
16262004|NCT00922480|Drug|Fimasartan|Fimasartan 60 ~ 120mg/po take one tablets once a day
16262005|NCT00922480|Drug|Losartan (Control)|Losartan 50 mg ~ 100 mg/po, take one tablets once a day
16262006|NCT00922467|Drug|NaCl 9/00|Same volume as in the esmolol group
16262007|NCT00922467|Drug|Esmolol|1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period
16262008|NCT00922454|Procedure|Endovascular Repair of the abdominal aorta|"Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.
~EVAR, CTA imaging, 1, 6 12 months post treatment."
16262009|NCT00922454|Device|Cook Zenith Stent-Graft|Cook Zenith AAA Endovascular Graft
16262010|NCT00922454|Device|Talent Stent-Graft|Talent AAA Abdominal Stent Graft System
16262011|NCT00922441|Drug|Fimasartan 60 mg group|Fimasartan 60 mg
16262012|NCT00922441|Drug|Fimasartan 120 mg group|Fimasartan 120 mg
16262013|NCT00922441|Drug|Reference (Valsartan 80 mg) group|Reference (Valsartan 80 mg)
16262014|NCT00922402|Procedure|Intensive insulin infusion|"The intensive control of glycemia is obtained with a shared in-hospital insulin infusion protocol, supported by the use of a continuous glucose monitoring system (Medtronic Guardian REAL Time). Any sudden variation of glycemia levels and/or alarms, as indicated by the device, has to be confirmed with a finger-stick before any therapy modification.
~In-hospital management is subdivided in a 2-day intensive and a 3-day post-intensive phase."
16262015|NCT00922389|Procedure|will receive G-CSF and peripheral blood derived mononuclear cells|Multiple intra muscular implantation of mononuclear stem cells derived from peripheral blood after G-CSF (granulocyte colony-stimulating factor)mobilization in either of two individual dose ranges which would be given to equal number of subjects.
16262016|NCT00922389|Drug|G-CSF|5 micrograms/kg/day for 4 days by subcutaneous route
16262017|NCT00922389|Drug|Standard Therapy|Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
16262189|NCT00920920|Radiation|3D MRI-guided Brachytherapy|MRI-based 3D-4D brachytherapy in locally advanced cervical cancer
16262018|NCT00922376|Device|Mobile phone telehealth application: Think Positive (T+)|T+ consists of the Glucometer paired with a cradle that transmits via Bluetooth blood glucose results to a mobile phone. Data is stored and sent to a secure website. The website can be accessed by the patient as well as by health care providers (HCP). HCP can discuss data on the phone and make recommendations via text messages to patients. Visual feedback (graphs and statistics) illustrating recent blood sugar levels patterns is automatically and immediately sent to the patient when data is transferred from the T+ phone.
16262019|NCT00922363|Biological|50 µg Ag85B-ESAT-6 alone|0.5 mL solution for injection x 2 (2 months interval)
16262020|NCT00922363|Biological|50 µg Ag85B-ESAT-6 + 125/25 µg CAF01|0,5 mL suspension for injection x 2 (2 months interval)
16262021|NCT00922363|Biological|50 µg Ag85B-ESAT-6 + 313/63 µg CAF01|0.5 mL suspension for injection x 2 (2 months interval)
16262022|NCT00922363|Biological|50 µg Ag85B-ESAT-6 + 625/125 µg CAF01|0.5 mL suspension for injection x 2 (2 months interval)
16262023|NCT00922350|Other|HELIOX|The nebulization was conducted in the same way that heliox + posture group, except the attitude of trunk, where the patients in this group did the Nebulizer with the trunk upright.
16262024|NCT00922350|Other|OXYGEN|The NEBULIZATION was performed the same way as the heliox group, except for torso posture, where the patients in this group with the trunk upright Nebulizer Oxygen for cars have A NEBULIZATION.
16262025|NCT00922350|Other|HELIOX+POSTURE|"Patients underwent two carried by heliox nebulization associated with fenoterol (2.5 mg) and ipratropium bromide (0.25 mg). We used three ml of saline solution at 0.9%. For nebulization with heliox or oxygen, was used a system of distribution not invasive, semi-closed in a mask that is non toxic connected to a piece Y with a nebulizer in a follow and a bag of tank with a capacity for 2.5 L in the other connected with a valve action. This system was used so that there was a dilution gas. The proportion of 80:20 heliox was used (80% helium: 20% oxygen). To postural change in groups and heliox Oxygen + posture + posture, oriented to the participants to maintain an angle of inclination of the trunk and elbows supported on the thighs, measured from the anterior axillary line and lateral epicondyle of the femur, between 50th and 60th ."
16262026|NCT00922350|Other|OXYGEN + POSTURE|The NEBULIZATION was conducted in the same way that heliox + posture GROUP, however the patients in this group have the Oxygen for Carr A NEBULIZATION
16262027|NCT00922337|Device|MGuard Coronary Stent system|MGuard Coronary Stent system implanted within a PCI
16262028|NCT00922324|Drug|STP206 or vehicle control|STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
16262029|NCT00922311|Drug|Aliskiren|Titrate from 150 mg daily to 300 mg daily
16262030|NCT00922285|Other|psychosocial support for caregiver|6 weekly 60 minute sessions
16262031|NCT00922285|Other|questionnaire administration|Evaluated at baseline, week 1 and week 6 of art therapy
16262032|NCT00922285|Procedure|quality-of-life assessment|Evaluated at baseline, week 1 and week 6 of art therapy
16262033|NCT00922285|Procedure|stress management therapy|6 weekly 60 minute sessions
16262034|NCT00922272|Drug|SPD489 (lisdexamfetamine dimesylate)|oral, 20, 30, 40, 50, 60, or 70 mg once daily
16262035|NCT00922272|Drug|Placebo matching SPD489 (lisdexamfetamine dimesylate)|oral, once daily
16262036|NCT00922259|Biological|Influenza A H7N7 vaccine|Participants will be administered two doses of the candidate vaccine at a dosage of approximately 10^7.5 50% tissue culture infectious dose (TCID50), in the form of nasal spray. The doses will be administered 28-62 days apart.
16262037|NCT00922246|Device|custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)|The custom made insoles (Thermo+Camel, cost for the military 20,50 euros) were fabricated from firm-density polyethylene and the hard plastic shell was a three-quarter length.
16262038|NCT00922233|Drug|levonorgestrel|oral contraceptive pills
16262039|NCT00922220|Other|stationary bike|Participants rode a stationary bike for five minutes
16262040|NCT00922220|Other|lumbar extension exercise|Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
16262041|NCT00922220|Other|spinal manipulative therapy|participants received spinal manipulative therapy to the low back
16262042|NCT00922207|Drug|Adefovir|From week -4 to week 2
16262043|NCT00922207|Drug|Entecavir|From week -4 to week 2
16262044|NCT00922207|Drug|Placebo|From week -4 to week 2
16262045|NCT00922207|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly, from week 1-48
16262046|NCT00922194|Drug|Extended Release Metformin|0.5g twice a day to 2g twice a day for at least 12 months or more
16262047|NCT00922181|Device|Microwave ablation|Liver tumors are destructed/ablated using single-probe microwave energy device
16262048|NCT00922181|Device|Radiofrequency ablation|Liver tumors are destructed/ablated using radiofrequency energy device
16262049|NCT00922155|Device|guide sheath|The guide sheath (GS) was originally the balloon covered sheath (MAJ-643R, external diameter 2.6mm) of the EBUS probe. The two ends of the balloon covered sheath were cut and trimmed. The EBUS probe was covered with guide sheath and then inserted through the working channel to the targeted bronchus.
16262050|NCT00922129|Drug|Sirolimus (Rapamune)|Started at 5 mg (Target levels 6-10mg/mL), Daily, PO, 24 months
16262051|NCT00922129|Drug|Cyclosporin (Neoral) or Tacrolimus (Prograf)|"Cyclosporin: 3-4 mg/kg, BID, PO, 24 months
~Tacrolimus: 0-.038-0.045 mg/kg, BID, PO, 24 months"
16262052|NCT00922116|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
16262053|NCT00922103|Procedure|Ileal Neo Rectal Anastomosis|Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis
16262054|NCT00922103|Procedure|Ileal Pouch Anal Anastomosis|Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis
16262055|NCT00922077|Behavioral|standard physical therapy program with emphasis on dynamic balance exercises|
16262056|NCT00922064|Procedure|ECT|ECT series consisting of 6 to 14 ECTs
16262057|NCT00922051|Device|Transcutaneous electrical nerve stimulation (TENS)|
16262058|NCT00922051|Device|Transcutaneous electrical nerve stimulation (TENS)|Placebo
16262059|NCT00922038|Behavioral|Cash reward|Enrollees testing negative for treatable sexually transmitted infections will receive cash rewards.
16263666|NCT00909831|Other|immunologic technique|
16262061|NCT00921973|Biological|VAX102|All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
16262062|NCT00921973|Biological|Placebo|All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
16262063|NCT00921960|Other|Intervention Care|Intervention Care is defined as a collaborative cardiovascular management between primary care and specialist hospital based services. This will involve natriuretic peptide guided evaluation of LVD and follow-up as appropriate - for example including echocardiographic assessment of left ventricular systolic dysfunction and appropriate pharmacotherapy.
16262064|NCT00921947|Biological|VAX102|Universal M2e influenza vaccine
16262065|NCT00921921|Drug|HFA-BDP|HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks
16262066|NCT00921921|Drug|Placebo|1 puff bid for 3 weeks, then 1 puff bid for 3 weeks
16262067|NCT00921908|Other|2 mBq radioactive technetium diluted in 20 mL saline|
16262068|NCT00921895|Device|RPS Adeno Detector IV|One time test with the RPS Adeno Detector IV
16262069|NCT00921882|Procedure|Oral glucose tolerance test|Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.
16262070|NCT00921869|Drug|E7050|The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
16262071|NCT00921856|Other|Intracoronary acetylcholine provocation test|Intracoronary provocation of coronary spasm with acetylcholine in augmented dosages of 2 µg, 20 µg, 100 µg and 200 µg non-selectively in the LCA as well as 80 µg in the RCA. During the procedure, a 12 channel ECG will be recorded.
16262072|NCT00921843|Drug|Methadone 0.1mg/kg|Subjects will receive methadone as their intraoperative opioid.
16262073|NCT00921843|Drug|Methadone 0.2mg/kg|Subjects will receive methadone as their intraoperative opioid.
16262074|NCT00921843|Drug|Methadone 0.3mg/kg|Subjects will receive methadone as their intraoperative opioid.
16262075|NCT00921843|Drug|Control|Subjects will not receive methadone as their intraoperative opioid.
16262076|NCT00921830|Drug|ibuprofen|Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast.
16262077|NCT00921804|Drug|AZD 8529|40mg oral daily capsule administered as a single dose in the morning for 28 days
16262078|NCT00921804|Drug|Risperidone|4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
16262079|NCT00921804|Drug|Placebo to match AZD8529|Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
16262080|NCT00921804|Drug|Placebo to match risperidone|Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
16262081|NCT00921791|Device|HBPM|Automatic oscillometric device for home blood pressure measurement and usual care.
16262082|NCT00921791|Device|HBPM and Pharmaceutical care|Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
16262083|NCT00921791|Behavioral|Pharmaceutical care|consultations with the pharmacists
16262084|NCT00921791|Other|Usual care|Consultation with the physician.
16262085|NCT00921778|Device|Lapcone|Use of Lapcone during LSH
16262086|NCT00921778|Procedure|laparoscopic supracervical hysterectomy|laparoscopic supracervical hysterectomy
16262087|NCT00921765|Drug|Saline|Saline single bolus dose followed by saline single bolus dose iv
16262088|NCT00921765|Drug|Saline + Ketamine|Single bolus dose of saline followed by ketamine 0.2 mg/kg bw
16262089|NCT00921765|Drug|Naloxone + Placebo|Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
16262090|NCT00921765|Drug|Naloxone + Ketamine|Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw
16262091|NCT00921739|Radiation|Esophageal sparing IMRT|6 fractions/week of 2Gy each for 29 fx (58 Gy), 31 fx (62 Gy), 33 fx (66 Gy), 35 fx (70 Gy), or 37 fx (74 Gy).
16262092|NCT00921726|Drug|Zanamivir|Continuous (800 mg in Regimen A, 3600 mg in Regimen C) and intermittent (3600 mg in Regimen D) infusion
16262093|NCT00921726|Drug|Oseltamivir|150 mg oral tablets taken five times over 3 days in Regimens A, B, C, and D
16262094|NCT00921713|Other|Oncology Nurse Care Management|
16262095|NCT00921713|Other|Patient-centered materials|
16262096|NCT00921700|Drug|Ibuprofen + Paracetamol|Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg in gelatine capsules
16262097|NCT00921700|Drug|Ibuprofen + Paracetamol + Codeine|Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg and codeine 60 mg in gelatine capsules
16262098|NCT00921700|Drug|Paracetamol + Codeine|Single oral dose of paracetamol (acetaminophen) 1000 mg combined with codeine 60 mg in gelatine capsules
16262099|NCT00921700|Drug|Placebo|Single oral dose of lactose as placebo in gelatine capsules
16262100|NCT00921687|Behavioral|Education only|The education will consist of a lecture and distribution of a CKD reference card.
16262101|NCT00921687|Behavioral|Multifactorial intervention|Providers in the intervention group will receive a lecture on CKD, a CKD reference card, academic detailing (residents only), and access to the CKD registry.
16262102|NCT00921674|Drug|ivermectin|Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
16262103|NCT00921661|Drug|AVE0005 (aflibercept)|IV infusion
16262104|NCT00921635|Procedure|Blood transfusion|Blood transfusion to maintain hemoglobin level above 120 g/L
16262105|NCT00921635|Procedure|Blood transfusion|Blood transfusion to maintain hemoglobin level above 100 g/L
16262106|NCT00921622|Dietary Supplement|Vitamin D|1000 IU twice daily for up to 10 days
16262107|NCT00921622|Dietary Supplement|Vitamin C|500 mg twice daily for up to 10 days
16262108|NCT00921609|Diagnostic Test|Oral glucose tolerance test|An oral glucose tolerance test is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
16262109|NCT00921596|Procedure|cardiac operation with totally endoscopic method|Cardiac operations are performed with three keyholes in the right chest wall. Video images are obtained by digital thoracoscope through one hole. Intracardiac lesions are accessed with surgical instruments and repaired through the other two holes. Cardiopulmonary bypass is set up with femoral cannulations. Moderate system hypothermic is applied for the operation. Cardiac arrest is achieved with ascending aorta clamp and cardioplegia solution delivery through aortic root cannulation. After the intracardiac lesions are repaired, aortic clamp is removed, and the heart is reperfused to restore its spontaneous rhythm. After the patients are rewarmed to normal temperature, CPB is discontinued. Femoral cannulations are removed, and surgical wounds are closed.
16262110|NCT00921583|Device|Long-term examination|Follow-up dental implants 20 year in function
16262111|NCT00921570|Drug|Amlodipine|calcium channel blocker (Amlodipine 10 mg) during 12 weeks
16262112|NCT00921570|Drug|Valsartan|AII receptor blocker inhibitor (Valsartan 160 mg) during 12 weeks
16262113|NCT00921557|Drug|Alendronate|Oral tablet taken once weekly: 70 mg if participant greater than 30 kg or 35 mg if participant less than or equal to 30 kg
16262114|NCT00921557|Drug|Placebo|Oral tablet taken once weekly
16262115|NCT00921557|Dietary Supplement|Calcium carbonate/vitamin D|Tablet taken once or twice daily: calcium carbonate (600 mg) and vitamin D (400 IU) once daily for participants with 25-OH-vitamin D levels greater than or equal to 20 ng/mL or twice daily for those with 25-OH-vitamin D levels less than 20 ng/mL
16262116|NCT00921544|Other|Sucrose|0.2 ml sucrose 24% given by mouth using a syringe and pacifier
16262117|NCT00921544|Other|Sterile water|Sterile water administered 2 mins prior to eye exam
16262118|NCT00921531|Drug|Thalidomide|"Thalidomide is used for adjuvant therapy for TACE
~Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day."
16262119|NCT00921531|Drug|TACE|TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.
16262120|NCT00921518|Drug|0.9% Sodium Chloride (Placebo)|0.9% Sodium Chloride (placebo) will infuse at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
16262121|NCT00921518|Drug|Sodium Bicarbonate|Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
16262122|NCT00921505|Drug|Ibuprofen|Tablet ibuprofen 400 mg oral single dose (1 tablet)
16262123|NCT00921505|Drug|Ibuprofen|Tablets (2 x 600 mg) oral single dose (2 tablets)
16262124|NCT00921505|Drug|Paracetamol (acetaminophen) 1000 mg|Tablets (2 x 500 mg) oral single dose (2 tablets)
16262125|NCT00921505|Drug|Paracetamol + ibuprofen|Tablets (ibuprofen 400 mg + paracetamol (acetaminophen) 2 x 500 mg) single oral dose (3 tablets)
16262126|NCT00921492|Device|Low-frequency electro-acupuncture (EA)|2 Hz EA during 30 minutes, twice a week, 14 weeks.
16262127|NCT00921492|Other|Meeting a therapist - attention control|Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.
16262128|NCT00921427|Behavioral|Vision Restoration Therapy (VRT)|30 min, twice a day, 3 days a week, 12 weeks
16262129|NCT00921427|Device|Transcranial direct current stimulation (tDCS)|2 mA/min, 30 min, twice a day, 3 days a week for 12 weeks
16262130|NCT00921414|Drug|Rituximab|2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
16262131|NCT00921414|Other|Watch and wait|No treatment patient follow-up every 2 months during 3 years
16262132|NCT00921401|Behavioral|Asthma Feedback|All participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
16262133|NCT00921388|Other|Varenicline and smoking cessation counseling|All subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program.
16262134|NCT00921388|Behavioral|Exercise or relaxation treatment|One hour exercise sessions twice a week for 8 weeks, then once a week for 8 weeks, then once every other week for 4 weeks. Subjects in the control group receive a relaxation program that controls for contact time.
16262135|NCT00921375|Drug|TULY|TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
16262136|NCT00921349|Procedure|Ligation of varices|all varices are ligated until obliteration
16262137|NCT00921349|Drug|Nadolol|Nadolol (beta-blocker)
16262138|NCT00921336|Drug|KW-2450|Dose escalation may proceed once >= 3 subjects have completed the Day 29 blood sample to evaluate glucose. The safety of each dose level will be established prior to enrollment of subjects in the next dose level. Dose escalation will proceed sequentially with accelerated escalation. Once the criteria for completing the accelerated titration are reached, dose escalation will follow a modified Fibonacci schedule. Up to 6 subjects will be enrolled at each dose level. Enrollment will proceed until the maximum tolerated dose (MTD) has been established or the highest dose level (800 mg/day) has been reached. The Sponsor will enroll up to 12 additional subjects, in an expanded safety cohort.
16262139|NCT00921323|Behavioral|Goal-setting group|This intervention group will be advised to increase their daily steps by at least 20% gradually over 3 months
16262140|NCT00921323|Behavioral|Control|The control group will be advised to continue to be physically active and record daily steps
16262141|NCT00921310|Drug|Pemetrexed|
16262142|NCT00921310|Drug|Temsirolimus|
16262143|NCT00921297|Procedure|Immediate Cataract Surgery|Cataract surgery, as part of standard of care, will be performed on 1/2 of the group under investigation.
16262144|NCT00921284|Drug|NaCl 9/00|Same volume as in the dexmedetomidine group
16262145|NCT00921284|Drug|dexmedetomidine|1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr
16262146|NCT00921271|Device|Monitoring of StO2|Monitoring of lower limb anterior compartment StO2, taking measurements on an hourly basis for the duration of the study protocol.
16262147|NCT00921258|Procedure|prostate biopsy|"patient of control group will have :
~1 prostate biopsy 3 months after diagnostic biopsy
~1 prostate biopsy each year during 2 years
~1 prostate biopsy each 2 years during 8 years"
16262148|NCT00921245|Drug|Darifenacin (Emselex, BAY79-4998)|Patients in daily clinical treatment receiving Emselex according to local drug information
16262149|NCT00921232|Behavioral|Questionnaires|"During a consultation:
~3 questionnaires (HADS, FRI, CRA)
~and a form for the sociodemographic data"
16262150|NCT00921219|Drug|ivermectin|Each subject will receive single doses of (i) 22.5 ml ivermectin oral solution (22.5 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
16262151|NCT00921206|Biological|VAX102|1 ug i.m. compared to 2 ug s.c.
16262152|NCT00921193|Device|Radiation Therapy Positioning System (RTPS)|
16262153|NCT00921180|Drug|Entecavir and peginterferon alfa-2a|Entecavir (Baraclude) 0.5 mg/day po at week 1-4 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52
16262154|NCT00921180|Drug|Placebo and peginterferon|Placebo 0.5 mg/day po at week 1-4 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52
16262155|NCT00921167|Drug|Bevacizumab/Irinotecan|Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks
16262156|NCT00921154|Drug|ivermectin|Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods with a 14 day wash-out period. Doses will be administered after an overnight fast.
16262157|NCT00921128|Drug|Muscimol|
16262158|NCT00921115|Drug|Fulvestrant|Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
16262159|NCT00921115|Drug|Anastrazole|Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
16262160|NCT00921102|Drug|Bupivacaine|12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
16262161|NCT00921102|Drug|Morphine|200 µg of a 200 µg/ml solution, intrathecally
16262162|NCT00921102|Drug|Isotonic saline solution|"0.9% NaCl solution
~0.1 ml, intrathecally in group Control and IV Atropine
~0.1 ml, intravenously in group Control and Intrathecal Atropine"
16262163|NCT00921102|Drug|Atropine|"100 µg of a 1 mg/ml preservative-free solution
~intrathecally in group Intrathecal Atropine
~intravenously in group IV Atropine"
16262164|NCT00921076|Behavioral|Gait Analysis|A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait.
16262165|NCT00921063|Drug|PD 0332334|250 mg capsule, BID for 4 weeks
16262166|NCT00921063|Drug|PD 0332334|100 mg capsule, BID for 4 weeks
16262167|NCT00921063|Drug|placebo|0 mg capsule, BID for 4 weeks
16262168|NCT00921063|Drug|Alprazolam extended release|1 mg capsule, BID for 4 weeks
16262169|NCT00921050|Drug|levothyroxine sodium|Daily intake (fasting) levothyroxine bimonthly adjusted; to keep TSH between 0.5 to 2.5 mUI/L range. Start with 12.5mcg an investigator other than the caregiver will review the TSH measurements to adjust levothyroxine dose that will contain the coded bottle with the pils given to patient.
16262170|NCT00921050|Drug|excipient without levothyroxine (placebo)|Daily intake (fasting) a pill. bimonthly adjusted; an investigator other than the caregiver will review the TSH measurements and pretend to adjust dose contained in the coded bottle with the pills given to patient.
16262171|NCT00921037|Procedure|Erbium-YAG laser vaporization|spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz
16262172|NCT00921024|Drug|CXA-101|intravenous
16262173|NCT00921024|Drug|Ceftazidime|intravenous
16262174|NCT00920998|Drug|Z-338|oral
16262175|NCT00920985|Drug|Gestodene/EE (FC Patch Low, BAY86-5016)|21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2
16262176|NCT00920985|Drug|Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A|21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
16262177|NCT00920972|Drug|Treatment Plan 1: Stratum 1|Day -50 to -21: Hydroxyurea 30mg/kg PO q day Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients <10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on Day 0...
16262178|NCT00920972|Drug|Treatment Plan 2: Strata 2, 3, or 4|Day -50 to -21: Hydroxyurea 30mg/kg PO q day… Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg/m2 IV... Day -7: Fludarabine 30mg/m2 IV... Day -6: Fludarabine 30mg/m2 IV... Day -5: Fludarabine 30mg/m2 IV... Day -4: Fludarabine 30mg/m2 IV... Day -4: Thiotepa 8mg/kg IV… Day -3: Melphalan 140 mg/m2 IV... (dose modifications for patients <10 kgs) Procedure/Surgery: Hematopoietic stem cell infusion on day 0...
16262179|NCT00920972|Drug|GVHD Regimen A: UCB Recipients|Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +5: Abatacept 10mg/kg IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV
16262180|NCT00920972|Drug|GVHD Regimen B: BM Recipients|Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg/kg IV Day +1: Methotrexate 7.5mg/m2 IV Day +3: Methotrexate 7.5mg/m2 IV Day +5: Abatacept 10mg/kg IV Day +6: Methotrexate 7.5mg/m2 IV Day +14: Abatacept 10mg/kg IV Day +28: Abatacept 10mg/kg IV Day +60: Abatacept 10mg/kg IV Day +100: Abatacept 10mg/kg IV Day +180: Abatacept 10mg/kg IV Day +270: Abatacept 10mg/kg IV Day +365: Abatacept 10mg/kg IV
16262181|NCT00920959|Drug|FP 100mcg|Once-daily dosing
16262182|NCT00920959|Drug|FSC 100/50mcg|Once-daily dosing
16262183|NCT00920959|Drug|Placebo|Once-daily dosing
16262184|NCT00920946|Drug|Dimebon|20 mg Dimebon orally TID
16262185|NCT00920946|Other|Placebo|Orally TID
16262186|NCT00920933|Biological|AIN457|
16262187|NCT00920933|Other|Placebo|
16262188|NCT00920933|Drug|prednisolone|
16263667|NCT00909831|Other|laboratory biomarker analysis|
16262190|NCT00920907|Biological|Ipilimumab|Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks
16262191|NCT00920894|Dietary Supplement|plant stanol ester|the effect of plant stanol esters on plasma lipids
16262192|NCT00920881|Device|FreeStyle Navigator Continuous Glucose Monitoring System|Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.
16262193|NCT00920868|Drug|dasatinib|dasatinib at 50 mg PO BID)
16262194|NCT00920868|Drug|bevacizumab|7.5 mg/kg IV day 1
16262195|NCT00920868|Drug|Oxaliplatin|130 mg/m2 IV day 1
16262196|NCT00920868|Drug|Capecitabine|850 mg/m2 PO BID on days 1-14
16262197|NCT00920855|Drug|bendamustine|"Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib.
~Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle."
16262198|NCT00920855|Drug|bortezomib|Bortezomib was administered at a dose of 1.0 mg/m^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.
16262199|NCT00920829|Drug|Naltrexone 50 Mg|Naltrexone 25 or 50 mg per titration schedule
16262200|NCT00920829|Drug|Placebo|placebo
16262201|NCT00920816|Drug|Axitinib (AG-013736)|axitinib will be given at a starting dose of 5 mg BID with continuous dosing
16262202|NCT00920816|Drug|Sorafenib|sorafenib will be given at a dose of 400 mg BID continuous dosing
16262203|NCT00920803|Drug|Placebo|Placebo will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. Placebo must be used immediately following mixing. Placebo will be administered orally, once daily for 14 days.
16262204|NCT00920803|Drug|SRT501|SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. The final drug product must be used immediately following mixing. SRT501 will be administered orally, once daily for 14 days.
16262205|NCT00920790|Biological|KW-0761|KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg.
16262206|NCT00920777|Behavioral|CBT|Individual Cognitive Behavior Therapy during 16 weeks
16262207|NCT00920777|Behavioral|CBT|Individual Cognitive Behavior Therapy during 8 weeks
16262208|NCT00920777|Behavioral|Control group|Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
16262209|NCT00920764|Drug|Placebo for Atrasentan 0.2 mg/mL solution|10 mL oral solution, daily, 8 weeks
16262210|NCT00920764|Drug|0.25 mg Atrasentan QD|10 mL oral solution, daily, 8 weeks
16262211|NCT00920764|Drug|0.75 mg Atrasentan QD|10 mL oral solution, daily, 8 weeks
16262212|NCT00920764|Drug|1.75 mg Atrasentan QD|10 mL oral solution, daily, 8 weeks
16262213|NCT00920751|Procedure|Water infusion|Water infusion in lieu of air insufflation during colonoscope insertion
16262214|NCT00920751|Procedure|Air insufflation|Conventional air insufflation colonoscopy
16262215|NCT00920738|Other|metabolic assessment|Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc).
16262216|NCT00920738|Other|questionnaire administration|Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2.
16262217|NCT00920725|Drug|Insulin (Aspart Insulin [Novolog], Regular Insulin)|"Aspart Insulin 0.2units/sq q 2 hours
~Regular Insulin 0.1units/kg/hr intravenous
~Aspart Insulin 0.1 units/kg/hr intravenous"
16262218|NCT00920712|Drug|Weiqi decotion|Decoction ,two times a day
16262219|NCT00920699|Drug|CoQ10|Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
16262220|NCT00920686|Drug|NXN-188|NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
16262221|NCT00920686|Drug|placebo|administered as 3 placebo hard gelatin capsules
16262222|NCT00920686|Drug|sumatriptan succinate|administered in a hard gelatin capsule with 2 capsules of placebo
16262223|NCT00920673|Procedure|MRI|MRI during 35 to 65 minutes
16262224|NCT00920660|Drug|Placebo|Matching placebo is supplied containing microcrystalline cellulose (Avicel PH 105). Placebo will be administered as eight matched capsules.
16262225|NCT00920660|Drug|0.25g SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.25g SRT2104 treatment visit will be administered as one SRT2104 capsule with 7 placebo capsules. Dosing will take place during one of the 6 treatment visits.
16262226|NCT00920660|Drug|Prednisolone|During the last treatment period, subjects will receive 30 mg open-label prednisolone.
16262227|NCT00920660|Drug|0.5g SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.5g SRT2104 treatment visit will be administered as two SRT2104 capsules with 6 placebo capsules. Dosing will take place during one of the 6 treatment visits.
16262228|NCT00920660|Drug|1g SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 1g SRT2104 treatment visit will be administered as four SRT2104 capsules with four placebo capsules. Dosing will take place during one of the 6 treatment visits.
16262268|NCT00920374|Biological|Fluarix™/Influsplit SSW®|single intramuscular dose on Day 0
16262229|NCT00920660|Drug|2g SRT2104|SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 2g SRT2104 treatment visit will be administered as eight SRT2104 capsules. Dosing will take place during one of the 6 treatment visits.
16262230|NCT00920647|Other|Control|3 dose cohorts were planned. Within each dose cohort, patients will be randomized to 1 of 2 treatment options: treatment with study drug or no treatment with 4 treated patients per dose group and a total of 4 untreated patients (1-2 untreated patients will be assigned in each dose cohort). They will not undergo surgical placement of an Intrathecal Drug Delivery Device (IDDD), and will not receive Idursulfase-IT.
16262231|NCT00920647|Drug|Idursulfase IT (1 mg)|The original design of the study was to test the dose levels of 10, 30 and 100 mg. This was based on a calculation of a minimally effective dose around 10 mg, with subsequent dose levels being chosen as increasing half-log steps. During the conduct of the study; however, it became clear that the 10 mg dose elicited a strong Pharmacodynamic response, as measured by a dramatic and sustained drop in the CSF GAG levels. This indicated the need to explore a lower level as a minimally effective dose level, leading to the introduction of the 1 mg group. Enrollment of patients in this dose cohort will commence after the last patient has been enrolled in 30 mg dose cohort. 4 patients will be undergo surgical placement of an IDDD and receive 1 mg idursulfase-IT as an IT injection via an IDDD once per month (ie, every 28 days) for 6 month.
16262232|NCT00920647|Drug|Idursulfase IT (10 mg)|Patients will be enrolled in 10 mg dose cohort and 30 mg dose cohort in a sequential, escalating fashion. 4 patients will undergo surgical placement of an IDDD and receive 10 mg idursulfase-IT as an intrathecal (IT) injection via an IDDD once per month (ie, every 28 days) for 6 month.
16262233|NCT00920647|Drug|Idursulfase IT (30 mg)|Patients will be enrolled in 10 mg dose cohort and 30 mg dose cohort in a sequential, escalating fashion. 4 patients will undergo surgical placement of an IDDD and receive 30 mg idursulfase-IT as an IT injection via an IDDD once per month (ie, every 28 days) for 6 month.
16262234|NCT00920634|Drug|Follitropin beta|For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.
16262235|NCT00920621|Dietary Supplement|Vitamin D 3 cholecalciferol|Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol
16262236|NCT00920621|Dietary Supplement|Vitamin D3|4000 IU of vitamin D3 administered orally once a day during pregnancy
16262237|NCT00920608|Drug|AZD9056|Tablets for oral use. 400 mg once daily for 7 days
16262238|NCT00920608|Drug|Methotrexate|Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.
16262239|NCT00920595|Drug|CEP-9722|Starting dose of CEP-9722 is 150 mg/day (total dose). The study consists of a 14-day cycle of CEP-9722 alone, and at least one 28-day cycle of CEP-9722 plus temozolomide (150 mg/m2/day on Days 1-5). Patients who are receiving clinical benefit may receive subsequent cycles of study drug treatment.
16262240|NCT00920582|Drug|Teplizumab (MGA031)|IV dosing daily for 14 days times 2 courses
16262241|NCT00920582|Drug|Placebo|IV dosing daily for 14 days times 2 courses
16262242|NCT00920556|Drug|5.0g SRT501|5.0g SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. SRT501 will be administered orally as a liquid suspension for 20 consecutive days in each 21 day cycle.
16262243|NCT00920556|Drug|Bortezomib|Bortezomib (1.3 mg/m2) will be given as an intravenous solution in a 3-5 second push on Day 1, 4, 8 and 11 in every 21 day cycle.
16262244|NCT00920543|Drug|Placebo|Twice daily dosing
16262245|NCT00920543|Drug|FP 100mcg|Twice daily dosing
16262246|NCT00920543|Drug|FP 500mcg|Twice daily dosing
16262247|NCT00920543|Drug|FP 250mcg|Twice daily dosing
16262248|NCT00920543|Drug|FSC 100/50mcg|Twice daily dosing
16262249|NCT00920543|Drug|FSC 250/50mcg|Twice daily dosing
16262250|NCT00920543|Drug|FSC 500/50mcg|Twice daily dosing
16262251|NCT00920517|Biological|rDEN2/4delta30(ME) vaccine|10^3 PFU dose
16262252|NCT00920517|Biological|Placebo|placebo for rDEN2/4delta30(ME) vaccine
16262253|NCT00920504|Behavioral|German PRO-SELF(c) Plus Pain Control Program (PCP)|Educational intervention directed at patients and their family caregivers to reduce cancer pain and related symptoms
16262254|NCT00920504|Other|Standard Care|Patients in the standard care group will receive routine care provided by their treating physicians without any further care concerning the PRO-SELF© PCP. Patients in the standard care group will be seen by a research nurse in their homes at weeks 1, 2, 4, 6, 8 and 10 and telephone interviews will be conducted at weeks 3, 5, 7 and 9 but the focus of the visits and phone calls will be data collection only.
16262255|NCT00920491|Biological|biomarker-enhanced disposition decision with proADM|To compare the outcome of standard of care with an approach combining the standardized course and biomarker levels (biomarker-enhanced disposition decision with proADM) for the disposition of patients with non-specific complaints presenting to the emergency department (ED), in order to evaluate safety.
16262256|NCT00920478|Other|Musculoskeletal Ultrasound|Gray scale and power doppler - to identify the presence of synovitis
16262257|NCT00920478|Other|28 Joint Disease Activity Score|Clinical assessment of synovitis - composite score incorporating 28 tender joint count, 28 swollen joint count, erythrocyte sedimentation rate and patient global VAS
16262258|NCT00920465|Drug|mifegyne and cytotec|One day dosage versus two days dosage
16262259|NCT00920439|Biological|PoliorixTM|Single dose, intramuscular administration.
16262260|NCT00920426|Drug|GSK1265744 30mg|GSK1265744 30 mg
16262261|NCT00920426|Drug|Placebo|Placebo to match GSK1265744
16262262|NCT00920426|Drug|GSK1265744 5mg|GSK1265744 5mg
16262263|NCT00920413|Dietary Supplement|Vitamin C|vitamin C 500mg orally once a day
16262264|NCT00920413|Dietary Supplement|placebo|
16262265|NCT00920387|Drug|Experimental 200 mcg Lysergic acid diethylamide|Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session
16262266|NCT00920387|Drug|Active Comparator 20 mcg lysergic acid diethylamide|Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session
16262267|NCT00920387|Behavioral|Psychotherapy|Psychotherapy provided by a male and a female psychotherapist
16262269|NCT00920361|Drug|Follitropin beta|Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.
16262270|NCT00920335|Other|tumoral sample|Ependymoma tumoral sample
16262271|NCT00920322|Device|rTMS 5 x weekly|Patients will receive rTMS five times weekly for 4 weeks
16262272|NCT00920322|Device|rTMS 3 times weekly|Patients will receive rTMS 3 times weekly for 4 weeks
16262273|NCT00920309|Drug|Rapamycin|The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml.
16262274|NCT00920309|Other|Standard of Care-Placebo|
16262275|NCT00920296|Drug|GSK1265744|GSK drug
16262276|NCT00920283|Device|Chrono Carbostent Carbofilm™ Coated Coronary Stent|
16262277|NCT00920283|Device|Driver Cobalt Alloy Coronary Stent|
16262278|NCT00920270|Drug|nebulized colistin|nebulized colistin 75 mg every 12 hours
16262279|NCT00920270|Drug|antibiotics|conventional parenteral antibiotics
16262280|NCT00920257|Drug|GSK2141795|GSK2141795 is an oral AKT inhibitor.
16262281|NCT00920244|Procedure|Cardiopulmonary resuscitation (CPR)|CPR is performed according to international and national guidelines on all patients.
16262282|NCT00920244|Drug|Epinephrine|According to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation.
16262283|NCT00920244|Drug|Atropine|According to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min.
16262284|NCT00920244|Drug|Amiodarone|According to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR.
16262285|NCT00920244|Device|External defibrillator|According to CPR guidelines patients with shockable rhythms may receive DC shocks. The defibrillator also stores physiological information regarding cardiac rhythm, pulse-oximetry, and end-tidal carbon dioxide (CO2) from endotracheal tube.
16262286|NCT00920231|Device|initial system|The computer vision system is used to assist blind subject to navigate an extended path with multiple turns within a hospital setting.The initial prototype system would have been successfully tested for outdoor navigation and basic object recognition tasks.
16262287|NCT00920231|Device|modified system|The problems associated with the initial system were identified and modified. This modified system was tested with a second separate group of subjects. The redesigned system is used to assist blind subject to navigate the same extended path with multiple turns within a hospital setting.
16262288|NCT00920218|Biological|Herpes Zoster Vaccine 1437173A|Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
16262289|NCT00920218|Biological|Placebo vaccine (saline)|1 or 3 doses of Placebo (saline) injected intramuscularly.
16262290|NCT00920205|Drug|MPC-3100 (an Hsp90 inhibitor)|oral daily dose for 21 days in a 28-day cycle
16262291|NCT00920192|Drug|Foretinib|Phase I starting dose 30 mg/day escalated to 45 mg/day; de-escalated to 30 mg/day. MTD for Phase II dose was 30 mg/day,
16262292|NCT00920166|Dietary Supplement|Pétunia 1|Infant formula used for non breastfed children
16262293|NCT00920166|Dietary Supplement|Regular formula|Infant formula used for non breastfed children
16262294|NCT00920153|Biological|bleomycin sulfate|Given IV
16262295|NCT00920153|Drug|ABVD regimen|Given IV
16262296|NCT00920153|Drug|carmustine|Given IV
16262297|NCT00920153|Drug|cisplatin|Given IV
16262298|NCT00920153|Drug|cytarabine|Given IV
16262299|NCT00920153|Drug|dacarbazine|Given IV
16262300|NCT00920153|Drug|dexamethasone|Given orally
16262301|NCT00920153|Drug|doxorubicin hydrochloride|Given IV
16262302|NCT00920153|Drug|etoposide|Given IV
16262303|NCT00920153|Drug|gemcitabine hydrochloride|Given IV
16262304|NCT00920153|Drug|ifosfamide|Given IV
16262305|NCT00920153|Drug|melphalan|Given IV
16262306|NCT00920153|Drug|methylprednisolone|Given IV
16262307|NCT00920153|Drug|mitoguazone|Given IV
16262308|NCT00920153|Drug|vincristine sulfate|Given IV
16262309|NCT00920153|Drug|vindesine|Given IV
16262310|NCT00920153|Drug|vinorelbine tartrate|Given IV
16262311|NCT00920153|Procedure|allogeneic hematopoietic stem cell transplantation|Patients undergo allogeneic stem cell transplantation
16262312|NCT00920153|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous stem cell transplantation
16262313|NCT00920140|Drug|GSK1120212|Starting dose based on GSK protocol MEK111054 and then dose escalation based on Dose Limiting Toxicities per protocol.
16262314|NCT00920140|Drug|GSK1120212|Dose will be maximum tolerated dose based on Phase I results.
16262315|NCT00920127|Dietary Supplement|AKL1|"Each dose of AKL1 or placebo will consist of two capsules which will be swallowed twice daily for 8 weeks.
~The morning dose of study medication should be taken at approximately the same time each morning between 7:00 am and 10:00 am and should consist of two 500 mg capsules and then repeated between 7.00 pm and 10 pm."
16262316|NCT00920114|Biological|blood sample|
16262317|NCT00920101|Drug|Atorvastatin|Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less.
16262318|NCT00920101|Behavioral|Lifestyle counseling|Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.
16262319|NCT00920088|Drug|darunavir/ritonavir|DRV/RTV 600/100mg
16262320|NCT00920088|Drug|lopinavir/ritonavir|LPV/RTV 400/100mg
16262321|NCT00920088|Drug|Midazolam|Midazolam 3mg
16262322|NCT00920088|Drug|Dextromethorphan|Dextromethorphan 30mg
16262323|NCT00920088|Drug|Flurbiprofen|Flurbiprofen 50mg
16262324|NCT00920088|Drug|GSK2248761|NNRTI under investigation
16262974|NCT00915005|Drug|Carboplatin|AUC 2 by vein 1 time each week for 7 weeks.
16262325|NCT00920075|Drug|Alendronate (Fosamax)|Pill, 35mg or 70mg depending upon the body weight for 12 months. This was given for participants during the open label or double blind study. Current study is a post study evaluation of the current status of bone density after the participants completed the study. In this post study, no treatment is involved.
16262326|NCT00920049|Behavioral|Persuasion|
16262327|NCT00920036|Device|StressEraser|A hand-held biofeedback device that facilitates resonant frequency of respiration
16262328|NCT00920023|Drug|Superparamagnetic Iron Oxide Magnetic Resonance Imaging|Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
16262329|NCT00920010|Other|biologic sample preservation procedure|
16262330|NCT00919997|Genetic|DNA analysis|Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
16262331|NCT00919997|Genetic|polymerase chain reaction|Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
16262332|NCT00919997|Other|fluorescence activated cell sorting|Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
16262333|NCT00919997|Other|questionnaire administration|Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
16262334|NCT00919997|Other|study of socioeconomic and demographic variables|Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
16262335|NCT00919997|Procedure|study of high risk factors|Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
16262336|NCT00919984|Drug|IP chemotherapy|IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
16262337|NCT00919958|Biological|PLX-PAD IM injection|Single treatment; multiple injections
16262338|NCT00919945|Other|Continuous feeding at time 1 and NPO at time 2|Continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 1 and NPO at time 2 (12 hours later)
16262339|NCT00919945|Other|NPO at time 1 and continuous feeding at time 2|NPO at time 1 and continuous nasogastric formula feeding (using Enfalac with iron 2400 kJ/L at a volume of 1ml/kg/h) at time 2 (12 hours later).
16262340|NCT00919932|Behavioral|Paper and pen homework|Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks.
16262341|NCT00919932|Device|Text message system homework.|Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks.
16262342|NCT00919919|Drug|progesterone|Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
16262343|NCT00919919|Drug|activella|Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
16262344|NCT00919906|Device|My Scrivener(R)|Twenty 20-minute sessions of the Handwriting Without Tears(R) instructional handwriting program, with substitution of hand-over-hand or self-generated repetitive motion writing by computer guided repetitive motion.
16262345|NCT00919893|Drug|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.
16262346|NCT00919893|Drug|Placebo|Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
16262347|NCT00919880|Drug|carboplatin+ paclitaxel|carboplatin AUC 2mg/mL*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
16262348|NCT00919880|Drug|paclitaxel|paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
16262349|NCT00919867|Drug|SPD503|SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
16262350|NCT00919867|Drug|VYVANSE|VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
16262351|NCT00919867|Drug|SPD503 and VYVANSE|SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
16262352|NCT00919854|Drug|Darunavir|Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg before dose adjustment. Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg darunavir tablets twice daily if weight more than or equal to 15 kg after dose adjustment.
16262353|NCT00919854|Drug|Ritonavir|Ritonavir oral solution (80 mg/mL) will be administered as 3 mg per kg body weight twice daily before dose adjustment and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
16262354|NCT00919841|Other|Ultrasound examination|Sequential three-dimension sonographic examination for the uterine size after vaginal delivery. The examination will be performed once a week, until the completion of 7 weeks after delivery.
16262355|NCT00919828|Device|Avivo System|Non invasive external monitoring device
16262356|NCT00919815|Drug|Ciclosporin|Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
16262357|NCT00919815|Drug|Prednisolone|prednisolone 40mg daily then reducing regimen over 24 weeks
16263668|NCT00909831|Other|mass spectrometry|
16262358|NCT00919802|Drug|Oxytocin|A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed.
16262359|NCT00919802|Other|Saline as a nasal spray|A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed.
16262360|NCT00919776|Drug|prednisolone|prednisolone 40mg daily then reducing regimen over 16 weeks
16262361|NCT00919776|Drug|ciclosporin|Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
16262362|NCT00919763|Drug|CD 2027|Topical Ointment; two applications daily, once in the morning and once in the evening for 4 weeks
16262363|NCT00919763|Drug|CD 2027 Vehicle|Topical Ointment, two applications daily, once in the morning and once in the evening for 4 weeks
16262364|NCT00919750|Other|Cytology Specimen Collection Procedure|Correlative studies
16262365|NCT00919737|Drug|NPC-08|Polifeprosan 20 with Carmustine 3.85%
16262366|NCT00919711|Drug|Actonel®|Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
16262367|NCT00919711|Drug|Denosumab|Denosumab 60 mg, once every 6 months, Subcutaneous
16262368|NCT00919685|Biological|blood sample|from rest of blood sample collected for other measurements
16262369|NCT00919672|Device|Sacral nerve stimulation|The stimulation is set individually to provide the best possible stimulation for each individual person. This setting is found before the study starts and will not be altered during the study.
16262370|NCT00919659|Dietary Supplement|parenteral nutrition|25kcal/kg bw with parenteral nutrition
16262371|NCT00919633|Drug|interferon alfa-2b|subcutaneous continuous infusion at one of three doses for 48 weeks
16262372|NCT00919633|Drug|peginterferon alfa-2b|1.5 μg/kg subcutaneous weekly for 48 weeks
16262373|NCT00919633|Drug|ribavirin, USP|All patients will receive oral ribavirin
16262374|NCT00919633|Device|external drug infusion pump|pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
16262375|NCT00919620|Behavioral|stage-specific case-management|Stage-specific case-management for psychosis by designated key-workers according to specified protocol
16262376|NCT00919607|Drug|quetiapine fumarate extended-release|200mg,oral,single dose
16262377|NCT00919607|Drug|quetiapine fumarate extended-release|300mg,oral,single dose
16262378|NCT00919594|Behavioral|Interpersonal Psychotherapy for Mothers (IPT-MOMS)|Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems.
16262379|NCT00919594|Behavioral|Brief Supportive Psychotherapy|Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments.
16262380|NCT00919555|Drug|Pioglitazone and Tretinoin|Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd)
16262381|NCT00919555|Drug|Tretinoin and Pioglitazone HCL|Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day
16262382|NCT00919555|Drug|Placebo|Placebo
16262383|NCT00919542|Drug|Ciclosporin|Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
16262384|NCT00919542|Drug|prednisolone|prednisolone 40mg daily then reducing regimen over 16 weeks
16262385|NCT00919516|Procedure|Bone marrow mononuclear cell implantation|Dual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location.
16262386|NCT00919503|Procedure|Allogeneic Bone Marrow Transplantation|Infused IV
16262387|NCT00919503|Biological|Anti-Thymocyte Globulin|Given IV
16262388|NCT00919503|Drug|Cyclosporine|Given IV or PO
16262389|NCT00919503|Drug|Fludarabine Phosphate|Given IV
16262390|NCT00919503|Other|Laboratory Biomarker Analysis|Correlative studies
16262391|NCT00919503|Drug|Methotrexate|Given IV
16262392|NCT00919503|Drug|Mycophenolate Mofetil|Given IV or PO
16262393|NCT00919503|Procedure|Peripheral Blood Stem Cell Transplantation|Infused IV
16262394|NCT00919503|Drug|Tacrolimus|Given IV or PO
16262395|NCT00919503|Radiation|Total-Body Irradiation|Undergo total body irradiation
16262396|NCT00919503|Drug|Treosulfan|Given IV
16262397|NCT00919503|Procedure|Umbilical Cord Blood Transplantation|Single or double unit umbilical cord blood transplant, infused IV
16262398|NCT00919490|Drug|ABT-333|Tablet, see arms for interventional description
16262399|NCT00919490|Drug|Placebo|Tablet, see arms for interventional description.
16262400|NCT00919464|Device|Pressure monitoring device|monitoring device inserted to measure thigh compartment pressures
16262401|NCT00919464|Device|Compartmental fracture pressure monitoring|
16262402|NCT00919464|Device|This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture|
16262403|NCT00919451|Drug|ciclosporin|Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
16262404|NCT00919438|Device|AVIVO™ Mobile Patient Management System|Non Invasive monitoring device
16262405|NCT00919425|Other|biologic sample preservation procedure|
16262406|NCT00919399|Drug|Exemestane|25mg a day during 4 months
16262407|NCT00919399|Drug|tamoxifen|One 20 mg tablet a day started 1 week after the first Aromasine intake
16262447|NCT00919022|Drug|Cyproterone Acetate (Androcur, BAY94-8367)|Patients in regular clinical practice receiving Androcur according to local drug information
16262408|NCT00919373|Procedure|Substrate modification|Catheter Ablation procedure - Substrate modification in sinus rhythm in case of unstable induced monomorphic Ventricular Tachycardia (VT) which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.
16262409|NCT00919373|Procedure|VT ablation|Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
16262410|NCT00919373|Procedure|ICD Implantation|Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
16262411|NCT00919360|Procedure|collection of maternal blood specimen prior to delivery|approximately 5 cc. of maternal blood will be drawn prior to delivery
16262412|NCT00919360|Procedure|collection of placental cord blood after delivery|approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped
16262413|NCT00919360|Procedure|collection of placental tissue|within 10 minutes of delivery, the placenta will be radially transected, and a full-thickness slice from the central region removed using sterile technique by scalpel.This will be placed into a pre-prepared container of RNA preservation medium.
16262414|NCT00919360|Procedure|collection of strip of decidua from uterine lining from cesarean section deliveries|A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.
16262415|NCT00919347|Other|ANSAR ANX 3.0 Software|"Three values are calculated by the ANSAR ANX 3.0® software of the spectral analysis of HRV and respiration:
~RFa an indicator of parasympathetic function with normal values between 0.5 and 10 bpm2;
~LFa an indicator of sympathetic function also with normal values between 0.5 and 10 bpm2;
~SB or the ratio of LFa/RFa with normal reference values of 0.4 to 3.0.
~The ANSAR ANX 3.0® software defines three different levels of autonomic neuropathy (autonomic dysfunction) as follows (see Figure 1):
~Cardiovascular Autonomic Neuropathy (CAN): resting parasympathetic insufficiency (not enough parasympathetic protection for the heart) or RFa < 0.1 bpm2.
~Diabetic Autonomic Neuropathy (DAN), or advanced autonomic dysfunction in non-diabetics, is defined as low autonomics: LFa < 0.5 bpm2 or 0.1 < RFa < 0.5 bpm2.
~Autonomic Dysfunction: normal resting LFa and RFa, but low LFa response to Valsalva or low RFa response to deep breathing."
16262416|NCT00919334|Device|Defocus Incorporated Soft Contact (DISC) lens|Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia
16262417|NCT00919321|Biological|Pneumococcal polysaccharide vaccine (PPV)|One intramuscular injection
16262418|NCT00919308|Other|Competency based simulation training|Completion of a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous catheter on a partial task training simulator with no technical errors.
16262419|NCT00919295|Drug|mirtazapine|mirtazapine 15 mg or 30 mg tablet daily at bedtime for 13 weeks
16262420|NCT00919295|Drug|placebo|placebo
16262421|NCT00919282|Drug|gemcitabine, folinic acid, 5-FU|gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
16262422|NCT00919269|Other|Cytology Specimen Collection Procedure|Correlative studies
16262423|NCT00919269|Other|Laboratory Biomarker Analysis|Correlative studies
16262424|NCT00919243|Drug|prednisone|1 mg/kg/day with a maximum dose of 60 mg/day given orally
16262425|NCT00919243|Drug|allopurinol|allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.
16262426|NCT00919230|Drug|Ferrous sulphate tablets|200mg twice daily for four weeks
16262427|NCT00919204|Drug|AG-013736 (axitinib)|Three single oral-doses of AG-013736 (5-mg, 7-mg and 10-mg) will be successively administered (each separated by a washout period of at least 7 days) to healthy Chinese volunteers in the fed state.
16262428|NCT00919191|Drug|Tretinoin gel|Tretinoin gel 0.04% used once daily in a split-face model
16262429|NCT00919191|Drug|Adapalene and Benzoyl peroxide|Adapalene .1% and Benzoyl peroxide 2.5%
16262430|NCT00919178|Biological|DEN4 Vaccine Candidate|"DEN4 Vaccine Candidate
~Participants will receive a single immunization on Study Day 0. Vaccine will be delivered by subcutaneous injection in the upper arm, at a volume of 0.5 mL."
16262431|NCT00919178|Biological|DEN4 Vaccine Placebo|"DEN4 Vaccine Placebo
~Participants will receive a single immunization on Study Day 0. Placebo will be delivered by subcutaneous injection in the upper arm, at a volume of 0.5 mL."
16262432|NCT00919139|Other|biologic sample preservation procedure|Blood and 3-4 cc bone marrow aspirate collected at same time (in association with treatment protocols on which patient is registered)
16262433|NCT00919126|Drug|Xenon|Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
16262434|NCT00919126|Drug|Xenon|Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
16262435|NCT00919126|Drug|Medical Air in Oxygen|Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
16262436|NCT00919113|Drug|2% sodium chondroitin sulfate|Weekly 20 mL Intravesical instillation
16262437|NCT00919113|Drug|Placebo|The identical buffer used in Uracyst for the same administration
16262438|NCT00919100|Device|Buzzy|"Buzzy is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front."
16262439|NCT00919100|Other|vapocoolant|venipuncture with vapocoolant spray offered
16262440|NCT00919087|Device|Avivo System|Non invasive external monitoring deive
16262441|NCT00919074|Procedure|Pancreatic duct stent|Placement of a pancreatic duct stent to facilitate bile duct cannulation
16262442|NCT00919074|Procedure|Pancreatic wire placement|Placement of a pancreatic wire to facilitate bile duct cannulation
16262443|NCT00919061|Drug|Gemcitabine|Gemcitabine: 800 mg/m^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
16262444|NCT00919061|Drug|Cisplatin|20 mg /m^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
16262445|NCT00919061|Drug|Sorafenib|400 mg PO once a day continuously.
16262446|NCT00919035|Drug|torisel|Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
16262448|NCT00919009|Procedure|TACE (Transcatheter Arterial Chemoembolization )|"TACE will be performed according to National Cancer Center protocol:
~Briefly, an arterial catheter was inserted into the femoral artery by the Seldinger method and placed in the hepatic artery. Tumor feeding vessels were superselected where possible, the catheter was inserted to the level of the segmental arteries, subsegmental arteries, or lobar branches, and a solution containing 20-60 mg of doxorubicin hydrochloride (ADM; Dong-a Pharmacy, Seoul, Korea) and 2-20 mLof iodized oil (lipiodol) was infused through the catheter (5 French) or microcatheter (2.8 or 3 French). The dosage of doxorubicin and lipiodol was determined according to the tumor size, the presence of arteriovenous shunts or extrahepatic collateral vessels, and the underlying liver functions"
16262449|NCT00918996|Procedure|Omission of Bladder Flap Creation|Omission of bladder flap creation by making uterine incision 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.
16262450|NCT00918983|Drug|NX-1207|Single intraprostatic injection of 2.5 mg NX-1207
16262451|NCT00918983|Drug|Placebo|Single intraprostatic injection of placebo
16262452|NCT00918957|Drug|Tobramycin Inhalation Powder|Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler.
16262453|NCT00918957|Drug|Placebo|Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.
16262454|NCT00918944|Other|Control|"The asthma disease management toolkit available to all practices in the EHR will consist of four elements:
~A data entry tool for capturing asthma control data
~Standardized documentation templates to facilitate severity classification
~Order sets to facilitate ordering controller medications
~An asthma care plan that can be supplied to families"
16262455|NCT00918944|Other|Intervention|"Three alerts and two reminders will be programmed:
~Alert providers to enter asthma severity classification if none is on file
~Alert providers to prescribe controller medications for persistent asthma if none on file
~Alert providers to complete an asthma care plan if none on file
~Remind providers to review the asthma care plan if it is already on file by providing a link to the form
~Remind providers that educational content is available on-line by providing a web link"
16262456|NCT00918931|Drug|Obatoclax Mesylate|30 mg given by vein over 3 hours on Days 1-3 of each 14-day study cycle.
16262457|NCT00918918|Dietary Supplement|Alcohol + orange juice|100 mL Vodka (37.5 vol%; 30 gram of alcohol/day) + 200 mL orange juice
16262458|NCT00918918|Dietary Supplement|Orange juice|200 mL orange juice
16262459|NCT00918905|Device|Telemonitor|"Within 24 hours after the patient was discharged due to exacerbation in COPD the telemedicine equipment was installed at the patient's home. The patients were included for four weeks followed by a visit to the outpatient clinic with. The patient had the equipment for approximately one week and had at least one follow-up phone call. Televideo consultations could be made from 8 AM to 3 PM every day. The patient could call the telemedicine department in the same period.
~During the televideo consultations the nurse made clinical observations (i.e. dyspnoea, anxiety), measured saturation and lung function and informed the patients how to prevent exacerbations. The telemedicine consultation was agreed on with the patient and the telemedicine nurse from day to day."
16262460|NCT00918892|Genetic|gene expression analysis|Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
16262461|NCT00918892|Other|immunohistochemistry staining method|Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
16262462|NCT00918892|Other|laboratory biomarker analysis|Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.
16262463|NCT00918879|Drug|Saxagliptin|Oral tablet, once daily for 24 weeks
16262464|NCT00918879|Drug|Placebo|Oral tablet, once daily for 24 weeks
16262465|NCT00918866|Drug|Definity|one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight
16262466|NCT00918853|Procedure|resection of adenocarcinoma of the head of the pancreas|quality standard for the resection of adenocarcinoma of the head of the pancreas
16262467|NCT00918840|Biological|DermaVir|DermaVir is a synthetic nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing 15 HIV proteins that assemble to HIV-like particles. DermaVir is topically administered with DermaPrep medical device to target the nanomedicine to Langerhans cells of the skin.These Langerhans cells migrate to the lymph node to induce cytotoxic T cells that can kill HIV-infected cells
16262468|NCT00918840|Biological|Placebo|Dextrose/glucose solution
16262469|NCT00918840|Drug|HAART|Three or more antiretroviral drugs that can fully suppress HIV RNA
16262470|NCT00918814|Drug|LIPO-102|Subcutaneous Injection
16262471|NCT00918814|Drug|Placebo|Placebo
16262472|NCT00918788|Other|biologic sample preservation procedure|Ex vivo samples of normal and malignant breast tissue; biopsy specimens are then fixed in formalin and submitted for histopathologic studies
16262473|NCT00918788|Other|immunohistochemistry staining method|The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
16262474|NCT00918788|Other|light microscopy|The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H&E staining and IHC).
16262475|NCT00918788|Other|medical chart review|Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.
16262476|NCT00918788|Procedure|histopathologic examination|The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
16263669|NCT00909831|Other|pharmacological study|
16262477|NCT00918788|Procedure|needle biopsy|Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle.
16262478|NCT00918788|Procedure|spectroscopy|Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements.
16262479|NCT00918775|Other|Follow-Up Care|Undergo follow-up
16262480|NCT00918775|Other|Laboratory Biomarker Analysis|Correlative studies
16262481|NCT00918762|Procedure|assessment of therapy complications|
16262482|NCT00918762|Procedure|diagnostic endoscopic surgery|
16262483|NCT00918762|Procedure|quality-of-life assessment|
16262484|NCT00918762|Procedure|therapeutic conventional surgery|
16262485|NCT00918762|Procedure|therapeutic endoscopic surgery|
16262486|NCT00918762|Procedure|transoral robotic surgery|
16262487|NCT00918762|Procedure|video-assisted surgery|
16262488|NCT00918749|Drug|150 mg|150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
16262489|NCT00918749|Drug|75 mg|75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
16262490|NCT00918749|Drug|100 mg|100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
16262491|NCT00918736|Drug|sodium hyaluronate|3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
16262492|NCT00918723|Drug|Fludarabine Phosphate|Given IV
16262493|NCT00918723|Drug|Cyclophosphamide|Given IV
16262494|NCT00918723|Biological|Rituximab|Given IV
16262495|NCT00918723|Drug|Vorinostat|Given PO
16262496|NCT00918697|Procedure|Mechanical debridement|For mechanical epithelial removal, an 8.0-mm optical zone marker was applied to the cornea, centering over the entrance pupil. A hockey spatula was used to remove the central corneal epithelium.
16262497|NCT00918697|Procedure|Alcohol-assisted debridement|For alcohol-assisted debridement, 20% ethyl-alcohol solution was instilled into an 8.0-mm well and kept in contact with epithelium for 20 seconds (being careful to avoid spillage over the areas not being treated). It then absorbed using a dry cellulose sponge followed by copious irrigation with BSS. The epithelium of the central cornea was removed using a blunt spatula.
16262498|NCT00918684|Drug|Escitalopram|10mg tab daily
16262499|NCT00918671|Other|No new specific intervention|No new specific intervention
16262500|NCT00918658|Other|biologic sample preservation procedure|All specimens will be collected using the Pathology Residual Tissue Procurement.
16262501|NCT00918658|Other|immunologic technique|Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.
16262502|NCT00918658|Other|laboratory biomarker analysis|Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.
16262503|NCT00918645|Drug|41 Ca|single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
16262504|NCT00918632|Drug|AG-013736|A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
16262505|NCT00918632|Drug|AG-013736|A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
16262506|NCT00918632|Drug|AG-013736|A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
16262507|NCT00918632|Drug|AG-013736|A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
16262508|NCT00918632|Drug|AG-013736|A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
16262509|NCT00918632|Drug|AG-013736|A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
16262510|NCT00918619|Device|Sangustop|Application of Sangustop haemostatic agent on resection area
16262511|NCT00918619|Drug|Tachosil|Application of Tachosil fibrin sealant on resection area
16262512|NCT00918606|Drug|LIPO-102|LIPO-102
16262513|NCT00918593|Drug|Electrochemotherapy|Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
16262514|NCT00918593|Radiation|Radiotherapy|Radiotherapy according to hospital procedures.
16262515|NCT00918593|Drug|Bleomycin|Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
16262516|NCT00918580|Biological|13-valent Pneumoccocal Conjugate Vaccine|2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
16262517|NCT00918567|Drug|atomoxetine|open label treatment dosed up to 1.8mg/kg/day
16262609|NCT00917774|Device|Gender specific LPS -Flex TKA|Total knee design created specific for female patients
16262518|NCT00918567|Behavioral|Behavior Modification Therapy|8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group
16262519|NCT00918554|Drug|Methotrexate|All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.
16262520|NCT00918554|Drug|Placebo|All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection of triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.
16262521|NCT00918528|Procedure|Internal urethrotomy|
16262522|NCT00918528|Drug|Mitomycin C - local injection|
16262523|NCT00918515|Drug|AZD3043|intravenous solution given once as intravenous infusion over 30 minutes
16262524|NCT00918502|Device|AVIVO system|Non invasive external monitoring device
16262525|NCT00918489|Drug|Vorinostat|Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.
16262526|NCT00918476|Drug|filibuvir + Oral Contraceptives|This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28).
16262527|NCT00918463|Drug|dasatinib|100 mg daily dosing
16262528|NCT00918450|Drug|ABT-263|"Continuous dosing until disease progression using one of the following formulations:
~25 mg/mL oral solution OR 50 mg/mL oral solution OR 2.0 grams/bottle powder for oral solution of 25 mg/mL when mixed OR 2.0 grams/bottle powder for oral solution of 50 mg/mL when mixed"
16262529|NCT00918424|Drug|Oxcarbazepine Extended Release|OXC XR is a once-daily formulation of oxcarbazepine and is given at the same dosage levels.
16262530|NCT00918411|Drug|Ramosetron|oral
16262531|NCT00918411|Drug|Placebo|oral
16262532|NCT00918398|Drug|AZD1981|100 mg iv infusion, single dose, 4 hours infusion
16262533|NCT00918398|Drug|AZD1981|514 mg oral solution, single dose
16262534|NCT00918398|Drug|AZD1981|500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
16262535|NCT00918398|Drug|AZD1981|500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
16262536|NCT00918385|Drug|Nilutamide|Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
16262537|NCT00918385|Drug|Dasatinib|Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
16262538|NCT00918346|Drug|Tafluprost 0.0015%|Eye drops, 0.015 mg/ml, once daily to affected eye(s)
16262539|NCT00918333|Drug|panobinostat|Given PO
16262540|NCT00918333|Drug|everolimus|Given PO
16262541|NCT00918333|Other|laboratory biomarker analysis|Correlative studies
16262542|NCT00918333|Other|pharmacological study|Correlative studies
16262543|NCT00918320|Drug|Temozolomide/Hycamtin (Topotecan)|"Temozolomide: bottles containing 5 capsules of 5, 20, 100 and 250 mg
~Hycamtin (Topotecan): a lyophilisate for infusion in vials containing 4 mg
~Patients receive during 5 days (Day 1 to Day 5):
~Temozolomide 150 mg/m2/day per os, dose will be adjusted to the closest 5 mg, followed one hour later by Hycamtin(Topotecan) 0.75 mg/m2/day as an intravenous infusion over 30 minutes"
16262544|NCT00918307|Drug|Varenicline|Day 1 to day 3 : 0.5 mg daily ; Day 4 to day 7 : 0.5 mg twice daily ; Day 8 to week 12 : 2 x 0.5 mg twice daily
16262545|NCT00918307|Drug|Placebo|Day 1 to day 3 : 1 pill daily ; Day 4 to day 7 : 2 pills daily ; Day 8 to week 12 : 2 pills twice daily
16262546|NCT00918294|Device|QuickOpt|The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.
16262547|NCT00918281|Drug|Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
16262548|NCT00918268|Biological|Influenza vaccine|One 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010
16262549|NCT00918255|Biological|adalimumab|Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
16262550|NCT00918255|Drug|Placebo|Subcutaneous injection using prefilled syringe containing 0.8 milliliters
16262551|NCT00918229|Device|balloon implant|Absorbable perirectal spacer implantation
16262552|NCT00918229|Procedure|Balloon implantation|Implantation of the balloon between the prostate and the anterior rectal wall
16262553|NCT00918216|Genetic|fluorescence in situ hybridization|Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
16262554|NCT00918216|Other|immunohistochemistry staining method|Additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
16262555|NCT00918216|Other|medical chart review|Patients' medical charts are reviewed to obtain clinical information
16262556|NCT00918216|Procedure|fluorescence spectroscopy|The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.
16262557|NCT00918216|Procedure|histopathologic examination|Hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis.
16262558|NCT00918216|Procedure|light-scattering spectroscopy|The freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or Raman spectroscopy.
16262559|NCT00918203|Biological|Olaratumab|15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered intravenously (IV) at 25 milligram/minute (mg/min), with a minimum infusion time of 30 minutes.
16262560|NCT00918203|Drug|Paclitaxel|200 mg/m2 is then administered IV over 3 hours
16262561|NCT00918203|Drug|Carboplatin|AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
16262565|NCT00918177|Drug|AP09004|
16262566|NCT00918177|Drug|Carbidopa/Levodopa, immediate release|
16262567|NCT00918164|Drug|PF-04457845|Single dose, 8 mg as oral tablet and solution formulation
16262568|NCT00918151|Other|No treatment given|Subject will only fill out a questionaire when entering the observational study
16262569|NCT00918138|Drug|Saxagliptin|Tablets, Oral, 5 mg, once daily, 4 weeks
16262570|NCT00918138|Drug|Metformin XR|Tablets, Oral, 1500 mg, once daily, 4 weeks
16262571|NCT00918138|Drug|Placebo matching Metformin XR|Tablets, Oral, 0 mg, once daily, 4 weeks
16262572|NCT00918138|Drug|Metformin XR|Tablets, Oral, 500 mg, once daily, 4 weeks
16262573|NCT00918138|Drug|Placebo matching Saxagliptin|Tablets, Oral, 0 mg, once daily, 4 weeks
16262574|NCT00918099|Procedure|Avaulta mesh|Insertion of a mesh vs conventional repair
16262575|NCT00918099|Procedure|Anterior repair|Conventional repair
16262576|NCT00918086|Dietary Supplement|Vitamin D pill|Oral tablet taken for 16 weeks
16262577|NCT00918086|Dietary Supplement|Placebo|An inactive pill that looks and tastes like the Vitamin D pill
16262578|NCT00918060|Drug|Camella sinensis gel|clinical effect of locally-delivered gel between Camella sinensis and placebo
16262579|NCT00918047|Drug|SPN-804O|Open Label study
16262580|NCT00918034|Drug|talaporfin sodium|LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
16262581|NCT00918034|Device|Transurethral illumination with light emitting diodes|A light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes
16262582|NCT00918034|Procedure|Placement|Placement of device in prostate urethra
16262583|NCT00918021|Drug|olanzapine|normal dosage of olanzapine (the same dosage as on hospital ward)
16262584|NCT00918021|Drug|placebo|placebo
16262585|NCT00918008|Genetic|Blood draw|The research intervention is the blood sample only collected prior to surgery. Analyses of the data will be made by correlating the gene profile expression with the pathologic finding at surgery and the clinical status of the patients 2 years after surgery.
16262586|NCT00917995|Device|Polypropylene Mesh, density 25-40g/square meter|colostomy with a prophylactic hernia mesh
16262587|NCT00917982|Other|vision therapy|
16262588|NCT00917943|Behavioral|Tailored Counseling Intervention Arm|Study staff contact women when they are between 28 and 34 weeks pregnant, confirm their non-smoking status, and make an appointment to explain the study further, obtain written informed consent, conduct the risk assessment, and collect baseline data. Bio-behavioral and pregnancy-specific factors are used to triage women in the treatment arm to one of four levels of stepped-care that includes one in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
16262589|NCT00917930|Behavioral|physical training|intensive cardiac rehabilitation program
16262590|NCT00917917|Behavioral|Type of physical activity (resistance, endurance)|"To determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
~Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and Group 3 performing both activities at low level, serves as a control group for physical activities."
16262591|NCT00917917|Behavioral|Restrictive diet|All subjects will have the same restrictive diet (500- 700 kcal/d).
16262592|NCT00917904|Drug|dapivirine|"dosage form: vaginal gel
~dosage: 1.25mg dapivirine/day
~frequency: once daily
~duration: 6 weeks"
16262593|NCT00917904|Drug|placebo|"dosage form: vaginal gel
~frequency: once daily
~duration: 6 weeks"
16262594|NCT00917891|Drug|dapivirine|"dosage form: vaginal gel
~dosage: 1.25mg dapivirine/day
~frequency: once daily
~duration: 6 weeks"
16262595|NCT00917891|Drug|placebo|"dosage form: vaginal gel
~frequency: once daily
~duration: 6 weeks"
16262596|NCT00917878|Dietary Supplement|Milk|500 mL low-fat milk added to high-fat meal
16262597|NCT00917878|Dietary Supplement|Protein|Milk protein in 500 mL water added to high-fat meal
16262598|NCT00917878|Dietary Supplement|Calcium|Milk calcium in 500 mL water added to high-fat meal
16262599|NCT00917878|Dietary Supplement|Control|Lactose in 500 mL water added to high-fat meal
16262600|NCT00917865|Drug|anti [18F]FACBC|Anti[18F]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.
16262601|NCT00917852|Device|Gore Conformable TAG Thoracic Endoprosthesis|Endovascular stent graft
16262602|NCT00917839|Drug|lamotrigine|100 mg, once daily, 12 months
16262603|NCT00917826|Drug|Arginine Butyrate|1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
16262604|NCT00917826|Drug|Ganciclovir|5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
16262605|NCT00917826|Drug|Valganciclovir|900 mg BID for 16 days (Days 6-21 of each 21 day cycle)
16262606|NCT00917813|Drug|KD-247|Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15
16262607|NCT00917813|Drug|Physiological saline|Cohort 1 - Physiological saline IV on Days 1, 8, and 15; Cohort 2 - Physiological saline IV on Days 1, 8, and 15; Cohort 3 - Physiological saline IV on Days 1, 8, and 15
16262608|NCT00917774|Device|Standard LPS flex TKA|TKA by Standard LPS flex TKA
16263670|NCT00909831|Procedure|autophagy inhibition therapy|
16262610|NCT00917761|Drug|Entecavir and peginterferon (Pegasys) (52 weeks)|Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52
16262611|NCT00917761|Drug|Peginterferon (Pegasys) (96 weeks)|Peginterferon alfa-2a 180 ug/week sc at week 1-96
16262612|NCT00917761|Drug|Peginterferon (Pegasys) (48 weeks)|Peginterferon alfa-2a 180 ug/week sc at week 1-48
16262613|NCT00917748|Drug|DOCETAXEL(XRP6976) + MODAFINIL|arm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily
16262614|NCT00917748|Drug|Modafinil|best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
16262615|NCT00917748|Drug|Placebo of Modafinil|Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
16262616|NCT00917735|Drug|Green tea extract supplement|Two green tea extract capsules twice daily after breakfast and dinner for one year
16262617|NCT00917735|Other|Placebo|Two placebo capsules twice daily after breakfast and dinner for one year
16262618|NCT00917709|Other|Imaging with IBVM|in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
16262619|NCT00917709|Other|Imaging with DATSCAN|in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
16262620|NCT00917709|Behavioral|neuropsychological evaluation|neuropsychological evaluation using neuropsychological tests
16262621|NCT00917696|Procedure|Comparator: Iontophoresis and Laser Doppler with ATP|Iontophoresis treatments with 10 mM ATP (adenosine triphosphate) solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.
16262622|NCT00917696|Procedure|Comparator: Iontophoresis and Laser Doppler with Saline|Iontophoresis treatments with 20 mM saline solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.
16262623|NCT00917657|Procedure|Photorefractive keratectomy|
16262624|NCT00917644|Drug|Atorvastatin|A single 80 mg dose of marketed 80 mg atorvastatin tablets
16262625|NCT00917644|Genetic|Atorvastatin|A single dose of new formulation of 80 mg atorvastatin tablets
16262626|NCT00917631|Procedure|Co-bedding (caring for twins in the same incubator)|"Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding.
~Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary.
~Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes)."
16262627|NCT00917618|Other|Exercise|Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.
16262628|NCT00917618|Other|Control|Patients randomized to the control arm were instructed not to change their baseline exercise programs
16262629|NCT00917605|Other|Robot-assisted therapy|Patients will receive an intervention for 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The Robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany), will be used in this project. The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension (Hesse et al., 2003; Hesse et al., 2005). Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. Mode 3 is an active mode as in 2, but the paretic arm had to overcome an individually set, initially isometric resistance to allow the bilateral movement. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually.
16262630|NCT00917592|Drug|amoxicillin plus clavulanic acid|intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days
16262631|NCT00917592|Drug|amoxicillin plus clavulanic acid|intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days
16262632|NCT00917579|Drug|Atorvastatin|A single 10 mg dose of marketed 10 mg atorvastatin tablets
16262633|NCT00917579|Drug|Atorvastatin|A single 10 mg dose of new formulation of 10 mg atorvastatin
16262634|NCT00917566|Device|Airtraq|intubation with airtraq
16262635|NCT00917566|Device|Macintoch|use Macintoch laryngoscope for intubation
16262636|NCT00917553|Drug|doxycycline monohydrate|50 mg
16262637|NCT00917553|Drug|Placebo|Cellulose Placebo Capsule
16262638|NCT00917527|Drug|Atorvastatin|Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
16262639|NCT00917501|Drug|OMega 3|Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day
16262640|NCT00917501|Drug|Placebo|Placebo given twice a day which will be compared to Omega 3
16262641|NCT00917488|Other|Standardization of allergenic extract (Gly. domesticus)|Allergenic extract for cutaneous prick-test
16262642|NCT00917462|Drug|Sorafenib, administered orally|Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
16262643|NCT00917462|Procedure|CT/MRI|A CT (computerized tomography) or MRI (magnetic resonance imaging) scan of the chest and abdomen will be obtained at baseline, after the first four weeks of therapy, at eight weeks, and then every eight weeks there afterwith a scheduling window of up to one to fourteen (1-14) days. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
16262644|NCT00917449|Drug|L-arginine|Oral L-arginine (3.2 gr bid)for 18 months
16262645|NCT00917449|Drug|Placebo|Oral Placebo BID for 18 months
16262646|NCT00917436|Drug|Thiocolchicoside|
16262647|NCT00917410|Behavioral|SMS support|"The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows.
~Remember to take your preventive asthma medication (sent at 8.00 am).
~Were you awakened during the night due to your asthma? Answer YES or NO.
~How many times have you taken your asthma attack medication during the last 24 hours? Answer a number.
~What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study)."
16262648|NCT00917397|Drug|Sertraline|varies
16262649|NCT00917397|Behavioral|trauma-focused cognitive behavioural therapy|once a week
16262650|NCT00917384|Biological|ramucirumab|Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
16262651|NCT00917384|Drug|Placebo|Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks
16262652|NCT00917384|Other|Best Supportive Care (BSC)|BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
16262653|NCT00917358|Drug|Pegylated interferon alfa-2a|Pegylated interferon alfa-2a 135 ug/week for 24 weeks
16262654|NCT00917345|Drug|captopril test|The blood samplings were obtained one hour after the administration of 50 mg of captopril.The testing is performed in the morning on a seated ambulatory patient
16262655|NCT00917332|Behavioral|"relaxation (breathing and muscles) and guided imagery (safe place)"|intervention group: daily practice of relaxation and guided imagery CD, for a rew weeks, until childbirth.
16262656|NCT00917319|Other|Bundling Infection Control Interventions|identify risk factors for developing HAIs, receive general infection control measures as well as infection control measures appropriate for the identified risk factor (s)
16262657|NCT00917306|Drug|PEP005 Gel|0.05% two day treatment
16262658|NCT00917293|Drug|Pyridoxal 5'-Phosphate|Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
16262659|NCT00917293|Drug|Placebo|Placebo 2 pills, po bid.
16262660|NCT00917267|Drug|exenatide once weekly|2.0mg subcutaneous injection, once a week
16262661|NCT00917267|Drug|exenatide twice daily|5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
16262662|NCT00917254|Drug|YM150|oral
16262663|NCT00917254|Drug|Placebo|oral
16262664|NCT00917254|Drug|Enoxaparin|injection
16262665|NCT00917241|Drug|MMI combined with IID|MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month.
16262666|NCT00917241|Drug|MMI|MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
16262667|NCT00917228|Device|recordings with device equipped|
16262668|NCT00917228|Device|Control|Recording without device equipped
16262669|NCT00917215|Device|Disposable stainless steel acupuncture (0.2mmx4mm)|"For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.
~For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks."
16262670|NCT00917202|Drug|Methylenblue|
16262671|NCT00917189|Behavioral|Challenging Our Minds Program|A computerized cognitive intervention that provides training in attention, memory, and executive function
16262672|NCT00917176|Device|Occipital nerve stimulation|
16262673|NCT00917163|Device|Supralimus(R) Sirolimus-Eluting Coronary Stent System|Drug eluting stent implantation in the treatment of coronary artery disease.
16262674|NCT00917163|Device|Xience V™ Everolimus Eluting Coronary Stent|Drug eluting stent implantation in the treatment of coronary artery disease
16262675|NCT00917150|Drug|tetomilast (OPC-6535)|oral administration of 12.5mg OPC-6535, once daily for 24months
16262676|NCT00917150|Drug|tetomilast (OPC-6535)|oral administration of 25mg OPC-6535, once daily for 24months
16262677|NCT00917150|Drug|tetomilast (OPC-6535)|oral administration of 50 mg OPC-6535, once daily for 24months
16262678|NCT00917150|Drug|placebo|oral administration of placebo, once daily for 24months
16262679|NCT00917137|Procedure|TBNA + transbronchial lung biopsy + bronchial washing|
16262680|NCT00917124|Device|INVOS|"Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur it can be responded with simple interventions to prevent a brain injury including: repositioning of the head or perfusion cannulae to avoid mechanical obstruction of cerebral blood flow, increasing arterial carbon dioxide tension within normal referent values, increasing oxygen inspiration concentration to maintain adequate tissue oxygen saturation, increasing arterial blood pressure, pump flow rate and cardiac index, temperature decreasing and increasing of anesthetic depth to reduce cerebral oxygen consumption and blood transfusion if hematocrit decreases below 22%.
~None of the interventions are outside the range of good clinical practice."
16262681|NCT00917111|Drug|Nasal CO2|Four times a day for 14 days
16262682|NCT00917111|Drug|Inactive Placebo Gas|Placebo
16262683|NCT00917098|Behavioral|Behavior Therapy|Eight weekly sessions during Phase 1 and four sessions every other week during Phase 2; participants will work on implementing habit reversal techniques with psychoeducation, cognitive restructuring, and relaxation, if necessary
16262684|NCT00917098|Behavioral|Supportive Counseling|Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors
16262685|NCT00917085|Behavioral|Skin-to-Skin contact|Infants in the Skin-to-Skin group also had standard care provided by hospital staff. In addition, the researchers facilitated skin-to-skin contact by placing diaper-clad infants prone between their mothers' breasts as soon as possible after birth. Thereafter the infants and their mothers experienced skin-to-skin contact as often as possible and for as long as possible each time throughout the protocol.
16262686|NCT00917072|Behavioral|Didactic|Group #1: will have a focused, interactive power point lecture on the background, content and guidelines for a good handoff (focus on a standardized electronic hand-off tool). They will have an exercise to complete
16263149|NCT00913848|Drug|Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)|
16262687|NCT00917072|Behavioral|Didactic+Simulation|Group #2: will undergo the same power point lecture ( as in Group #1) with an additional intervention focused not only on the hand-off tool, but on a standardized hand-off process using an OSCE exercise (objective structured clinical exam). This group will be trained about the effective implementation of the hand-off tool. They will be taught how to standardize the hand-off process and will be given an opportunity to practice with their peers in the HFH simulation center
16262688|NCT00917072|Behavioral|Control|The control group received no formal handoff training other than an introduction to handoffs for all interns during orientation at the start of the academic year along with expected ward based experiential training from senior residents throughout the intern year.
16262689|NCT00917059|Drug|Escitalopram|Fixed dose of 10 mg per day
16262690|NCT00917059|Drug|Bupropion XL|Fixed dose of 150 mg per day
16262691|NCT00917046|Behavioral|high-intensity interval training|3 weekly sessions of high-intensity interval training in 12 weeks
16262692|NCT00917046|Behavioral|Moderate continuous training|3 weekly sessions of moderate continuous training for 12 weeks
16262693|NCT00917046|Behavioral|Recommendation of regular moderate exercise|Recommendation of regular exercise at moderate intensity at individual choice. In addition patients will meet for treadmill walking in order to motivate for post intervention testing
16262694|NCT00917033|Device|GlideScope|Orotracheal intubation
16262695|NCT00917033|Device|Macintosh direct laryngoscope|Orotracheal intubation
16262696|NCT00917020|Drug|Nasal CO2|As-Needed during the 14 day Treatment Period
16262697|NCT00917020|Drug|Inactive Placebo Gas|Placebo
16262698|NCT00916994|Device|SpaceGuard Balloon|Positioning of the balloon into the subacromial space between the humerus head and the acromion
16262699|NCT00916981|Procedure|percutaneous autologous preosteoblast cells implantation|percutaneously injection of preosteoblast into the nonunion under radioscopic control
16262700|NCT00916968|Device|Standard CR-Flex total knee|total knee implant used for joint replacement surgery of the knee
16262701|NCT00916968|Device|Gender specific CR-Flex|TKA by Gender specific Nexgen CR-Flex
16262703|NCT00916942|Drug|capsaicin 8%|High concentration capsaicin 8% dermal patch applied for one hour
16262704|NCT00916942|Drug|Lidocaine (2.5%)/Prilocaine (2.5%) Cream|Pre-treatment for NGX-4010
16262705|NCT00916929|Device|Impedance Monitoring Feature|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
16262706|NCT00916916|Other|Blood draw|A blood draw will occur to take 10cc of blood to measure lanreotide levels.
16262707|NCT00916890|Drug|Morphine|After a titration phase with fast-release oral morphine, once the optimal dosage (no side effects and less than two rescue doses per day) is reached, an equipotent dose of oral sustained-release morphine will be randomly assigned to a patient.
16262708|NCT00916890|Drug|Oxycodone|After a titration phase with fast-release oral morphine, once the optimal dosage (no side effects and less than two rescue doses per day) is reached, an equipotent dose of oral extended-release oxycodone will be randomly assigned to a patient.
16262709|NCT00916890|Drug|Fentanyl|After a titration phase with fast-release oral morphine, once the optimal dosage (no side effects and less than two rescue doses per day) is reached, an equipotent dosage of transdermal fentanyl will be randomly assigned to a patient.
16262710|NCT00916890|Drug|Buprenorphine|After a titration phase with fast-release oral morphine, once the optimal dosage (no side effects and less than two rescue doses per day) is reached, an equipotent dosage of transdermal buprenorphine will be randomly assigned to a patient.
16262711|NCT00916877|Radiation|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation
16262712|NCT00916825|Behavioral|"rehabilitation programme getting better together"|Mothers and their children (age 0-16) take part in a 3-week, family-oriented oncological rehabilitation programme which consists of medical, psychological and psychooncological treatments for mothers and children.
16262713|NCT00916799|Device|Use of Telehealth equipment (Viterian V-100)|Patient will daily enter answers to questions generated from a home telehealth monitor
16262714|NCT00916773|Device|continuous positive airway pressure (CPAP)|CPAP of optimal pressure used during sleep for 3 months
16262715|NCT00916760|Biological|Depigoid Parietaria judaica 1000DPP/ml|Subcutaneous monthly treatment
16262716|NCT00916760|Biological|Placebo|Subcutaneous monthly treatment
16262717|NCT00916747|Drug|Lonafarnib, Zoledronic Acid, and Pravastatin|"Lonafarnib: Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Lonafarnib will be orally administered without planned breaks, approximately every 12 hours, for a period of 24 months. For patients unable to swallow capsules, the capsules can be opened and dissolved into Ora Blend SF or Ora-Plus.
~Zoledronic Acid: Zoledronic acid will be administered intravenously at week one, and months 6, 12, 18 and 24 of this treatment trial. Treatment will consist of one infusion over a 30 minute period.
~Pravastatin: Pravastatin will be orally administered once daily without planned breaks, approximately every 24 hours, for a period of 24 months. The drug may be taken with meals. For patients unable to swallow pills, pills can be crushed into food. Pravastatin will be dosed according to the patient weight. Patients less than 10 kg will receive 5 mg pravastatin orally, once daily. Patients weighing 10 kg or greater will receive 10 mg pravastatin daily."
16262718|NCT00916734|Procedure|MDT (McKenzie Method)|Subjects who perform exercises in their direction of preference.
16262719|NCT00916734|Procedure|Spinal thrust manipulation|Subjects who receive spinal thrust manipulation as an intervention.
16262720|NCT00916721|Drug|Propranolol|Visit 2 (first smoking-related memory reactivation session) the subject will be given 0.67 mg/kg (minimum 40 mg; maximum 80 mg) of short-acting propranolol (or placebo) rounded to the nearest 10 mg. Ninety minutes after this dose, if subject has tolerated the short-acting dose well, and if systolic blood pressure has not fallen by 10 mmHg or more to below 100 mmHg, the subject will be given oral long-acting propranolol 1 mg/kg (minimum 60 mg; maximum 120 mg) or placebo rounded to the nearest 20 mg. . If the subject tolerates the combination dose well, during treatment phase (from visit 7 to 12), both the short- and long-acting doses will be given together immediately prior to memory reactivation.
16262752|NCT00916409|Device|NovoTTF-100A device|patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
16262721|NCT00916721|Drug|Placebo|Visit 2 (first smoking-related memory reactivation session) the subject will be given 0.67 mg/kg (minimum 40 mg; maximum 80 mg) of short-acting propranolol (or placebo) rounded to the nearest 10 mg. Ninety minutes after this dose, if subject has tolerated the short-acting dose well, and if systolic blood pressure has not fallen by 10 mmHg or more to below 100 mmHg, the subject will be given oral long-acting propranolol 1 mg/kg (minimum 60 mg; maximum 120 mg) or placebo rounded to the nearest 20 mg. . If the subject tolerates the combination dose well, during treatment phase (from visit 7 to 12), both the short- and long-acting doses will be given together immediately prior to memory reactivation.
16262722|NCT00916708|Procedure|Intensive/Low-Risk follow up (IA G1; IA G2)|"- First 2 years of FU since the end of primary treatment: clinical visit* every 4 months; Pap tests; chest, abdomen, pelvis CT every 12 months
~- Since the third to the fifth year of FU: clinical visit* every 6 months; Pap test every 12 months
~* clinical visit with gynecological exploration"
16262723|NCT00916708|Procedure|Intensive/High-Risk follow up (≥ IA G3)|"- First 3 years of FU since the end of primary treatment: clinical visit*, Ca125, trans-vaginal and abdominal ultrasound every 4 months (except in conjunction with TC); Pap smear, abdomen, pelvis CT every 12 months
~- In the fourth and fifth years of FU: clinical visit*, Ca125, trans-vaginal and abdominal ultrasound every 6 months (except in conjunction with TC) Pap smear; chest, abdomen, pelvis CT every 12 months
~* clinical visit with gynecological exploration"
16262724|NCT00916708|Procedure|Minimalist/Low-Risk follow up (IA G1; IA G2)|"- First 5 years of FU since the end of primary treatment: clinical visit* every 6 months.
~* clinical visit with gynecological exploration"
16262725|NCT00916708|Procedure|Minimalist/High-Risk follow up (≥ IA G3)|"- First 2 years of FU since the end of primary treatment: clinical visit* every 4 months; chest, abdomen, pelvis CT every 12 months
~- Since the third to the fifth year of surveillance: clinical visit* every 6 months.
~* clinical visit with gynecological exploration"
16262726|NCT00916695|Device|Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.|"Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique.
~Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique."
16262727|NCT00916669|Drug|Etoposide|Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
16262728|NCT00916669|Drug|Cisplatin|Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
16262729|NCT00916669|Drug|enoxaparin sodium|Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
16262730|NCT00916656|Biological|Fibrinogen Concentrate, Human (FCH)|"Intravenous (IV) infusion to reach the peak target levels of 100 mg/dL with an accepted lower limit of 80 mg/dL on at least 3 subsequent days for minor bleeding episodes and 150 mg/dL with an accepted lower limit of 130 mg/dL on at least 7 subsequent days for major bleeding episodes.
~If a subject's fibrinogen level is not known on Day 1, at the time treatment is initiated for the acute bleed (e.g., because they did not have a screening visit), the starting dose is to be 70 mg/kg b.w. Otherwise, the dose will be calculated individually."
16262731|NCT00916656|Biological|Cryoprecipitate|Patients that received on-demand treatment with Cryoprecipitate for a classified bleeding event (minor or major) with a documented hemostatic efficacy assessment.
16262732|NCT00916643|Device|HELP Secura (apheresis treatment)|Process is described in Arm (above).
16262733|NCT00916630|Drug|pemetrexed|Given intravenously over a 10 to 20 minute period once every 14 days.
16262734|NCT00916617|Drug|bapineuzumab|5 mg/week subcutaneous bapineuzumab
16262735|NCT00916604|Drug|AZD1656|Three increasing dose-steps with oral suspension, 8 days treatment
16262736|NCT00916604|Drug|Placebo|Placebo oral suspension, 8 days treatment
16262737|NCT00916578|Radiation|Radiation Therapy|50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.
16262738|NCT00916578|Drug|Capecitabine|During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.
16262739|NCT00916552|Drug|Erythropoietin|40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
16262740|NCT00916539|Device|Cast that immobilizes the thumb|Cast that immobilizes the thumb
16262741|NCT00916539|Device|Cast that does not immobilize the thumb|Cast that does not immobilize the thumb
16262742|NCT00916526|Procedure|bronchial provocation test with mannitol|"Bronchial provocation test with mannitol: Aridol is supplied in kit form containing sufficient capsules to complete one complete challenge, and the inhalation device.
~Apply nose clip and subject should be directed to breathe through the mouth
~Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and once only (a second puncture may fragment the capsules)
~The patient should exhale completely, before inhaling from device in a controlled rapid deep inspiration
~At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip
~At the end of 60 seconds, measure the FEV1 in duplicate (this becomes baseline FEV1)
~Insert 5 mg capsule into inhalation device, and proceed as above
~Repeat steps 1 - 4 following the dose steps in the table below until the patient has a positive response or 635 mg has been administered."
16262743|NCT00916500|Drug|CONCURRENT CHEMORADIATION (CISPLATIN)|Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
16262744|NCT00916487|Dietary Supplement|Fructosin|Three capsules of Fructosin before one of the hydrogen breath tests.
16262745|NCT00916474|Drug|telaprevir|
16262746|NCT00916461|Drug|Minocycline|Minocycline + treatment as usual. 50 mg twice daily increasing to 200 mgs per day, increments of 50 mgs every 2 weeks.
16262747|NCT00916461|Drug|Placebo|Placebo + treatment as usual.
16262748|NCT00916448|Drug|Atazanavir|capsules of 150 mg, 2 capsules, twice daily on 4 consecutive days
16262749|NCT00916448|Drug|E. coli endotoxin|2 ng/kg E. coli reference endotoxin 11:H 10:K negative intravenously
16262750|NCT00916422|Biological|Allergen extract (Phleum pratense)|Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
16262751|NCT00916422|Biological|Placebo|Subcutaneous monthly treatment
16262753|NCT00916409|Drug|Temozolomide|"maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
~Cycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles."
16262754|NCT00916396|Drug|Dehydroepiandrosterone|100 mg of DHEA a day (50 mg twice a day) for six weeks
16262755|NCT00916396|Drug|placebo|100 mg of Placebo a day (50 mg twice a day) for six weeks
16262758|NCT00916370|Device|Core size Xience Prime|Core size includes a range of stent sizes.
16262759|NCT00916370|Device|Xience Prime Long Lesion (LL)|Long lesion stent sizes include a range of sizes.
16262760|NCT00916357|Drug|Humalog|
16262761|NCT00916357|Drug|Humulin-R|
16262762|NCT00916357|Drug|Recombinant human hyaluronidase PH20 (rHuPH20)|
16262763|NCT00916344|Device|EVIA Pacemaker|patient has standard indication for pacemaker therapy
16262764|NCT00916331|Procedure|subcutaneous indwelling|vacuum drainage is indwelled in subcutaneous layer
16262765|NCT00916331|Procedure|intraarticular indwelling|vacuum drainage is indwelled in intraarticular space
16262766|NCT00916318|Behavioral|Obesity-Children|"(A) internet based information and communication tool Sundabarn.se(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group."
16262767|NCT00916305|Other|Modified Audio video|An audio video modified to mimic noise induced hearing loss after one night at a loud club
16262768|NCT00916305|Other|Unmodified audio video|An audio video with unaltered music
16262769|NCT00916292|Drug|FGF-1 141|Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. Low dose: FGF-1, 0.3 mg per square centimeter.
16262770|NCT00916292|Drug|FGF-1 141|Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. High dose: FGF-1, 3.0 mg per square centimeter.
16262771|NCT00916279|Device|Lutonix Paclitaxel-Coated Balloon|PTCA
16262772|NCT00916266|Procedure|Stem cell transplantation|Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography
16262773|NCT00916253|Drug|Modafinil|"Modafinil is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
~during 3 days at home
~during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day and 2 driving sessions (one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under treatment (Modafinil)."
16262774|NCT00916253|Drug|Placebo|"Placebo is taken by narcoleptics or hypersomniacs during 5 successive days, twice a day (at the breakfast and at the lunch):
~during 3 days at home
~during the period of 2 nights and 2 successive days of hospitalization in order to realise a Maintenance of Wakefulness Test the first day, and 2 driving sessions ( one simulated driving during the morning and one real driving during the afternoon) of 2 hours each the day after, under Placebo."
16262775|NCT00916240|Behavioral|Multisystemic Therapy|Treatment will consist of a home- and community-based intensive intervention. Psychological treatment sessions will be provided in participants' homes, at a time designated by the participant and will last about 1 hour.
16262776|NCT00916240|Behavioral|Home-based, Non-Directive Family Support|Treatment will consist of Rogerian, client-centered, non-directive counseling. Participants will receive weekly home-based, supportive family counseling, with sessions lasting about 45 minutes.
16262777|NCT00916227|Drug|ARRY-614, p38/Tie2 inhibitor; oral|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
16262778|NCT00916214|Other|Pharmaceutical care program|The pharmaceutical care program consists of 2 elements, that includes individualized medication education and regular follow up
16262779|NCT00916201|Drug|URB597|10 mg / d for 5 days, orally
16262780|NCT00916201|Drug|intranasal Insulin|160 IU / d for 5 days, intranasal
16262781|NCT00916201|Drug|Cannabidiol CR|320 mg / d for 5 days, orally
16262782|NCT00916188|Dietary Supplement|Black Tea Extract|Amount/dose depends on Arm assignment.
16262783|NCT00916175|Dietary Supplement|P1&P2|"First period (4 weeks) intake food product P1&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
~Second period, cross over from AG&CC group, 4 weeks intake food product P1&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet"
16262784|NCT00916175|Dietary Supplement|P1&CC|"First period (4 weeks) intake food product P1&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
~Second period, cross over from AG&P2 group, 4 weeks intake food product P1&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet."
16262785|NCT00916175|Dietary Supplement|AG&P2|"First period (4 weeks) intake food product AG&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
~Second period, cross over from P1&CC group, 4 weeks intake food product AG&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet"
16262786|NCT00916175|Dietary Supplement|AG&CC|"First period (4 weeks) intake food product AG&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
~Second period, cross over from P1&P2 group, 4 weeks intake food product AG&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet"
16262836|NCT00916019|Other|exercise training|60 min of low-intensity exercise, 5 days/week, 12 weeks
16262837|NCT00916006|Drug|PEP005 Gel|0.015%, three day treatment
16262787|NCT00916175|Dietary Supplement|TA (concentrated 5:1 aloe vera gel)|"First period (4 weeks) intake food product TA (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
~Second period, cross over from P3 group, 4 weeks intake food product TA (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet."
16262788|NCT00916175|Dietary Supplement|P3|"First period (4 weeks) intake food product P3 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
~Second period, cross over from TA group, 4 weeks intake food product P3 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet."
16262789|NCT00916149|Drug|levetiracetam|The dosage of levetiracetam will begin at 500mg twice per day (bid) for the first 4 days, and increase by 500mg every 5 days thereafter until a goal of 1500mg bid is reached. The subject will then remain on levetiracetam at 1500mg bid for 8 weeks, until the conclusion of the study. Medication will be supplied in 500mg tablets, to be taken orally.
16262790|NCT00916149|Drug|Lamotrigine|"The drug will be supplied in 25, 100 and 150mg tablets, to be taken orally per the titration schedule below:
~The regimen will begin at 25mg once per day for the first two weeks, and increase to 50mg once per day during weeks 3 and 4. In week 5, the subject will take 50mg twice per day (bid). The dosage will increase to 50mg in the morning and 100mg at night during week 6. During week 7 the subject will take 100mg bid. During week 8, the subject will take 100mg in the morning and 150mg at night. At week 9, the subject will reach the target dose of 150mg bid. The subject will then remain on lamotrigine at 150mg bid for 7 weeks, until the conclusion of the study."
16262791|NCT00916136|Procedure|Femoral Traction|Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.
16262792|NCT00916123|Drug|Docetaxel|75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
16262793|NCT00916123|Drug|Prednisone|10 mg per day starting on cycle 1, day 1
16262794|NCT00916123|Drug|177Lu-J591|Two infusions of 177Lu-DOTA-J591 at 20 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
16262795|NCT00916123|Drug|177Lu-J591|Two infusions of 177Lu-DOTA-J591 at 25 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
16262796|NCT00916123|Drug|177Lu-J591|Two infusions of 177Lu-DOTA-J591 at 30 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
16262797|NCT00916123|Drug|177Lu-J591|Two infusions of 177Lu-DOTA-J591 at 35 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
16262798|NCT00916123|Drug|177Lu-J591|Two infusions of 177Lu-DOTA-J591 at 40 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
16262799|NCT00916110|Drug|ATN-103|1.5 mg solution, single subcutaneous injection
16262800|NCT00916110|Drug|ATN-103|4 mg solution, single subcutaneous injection
16262801|NCT00916110|Drug|ATN-103|10 mg solution, single subcutaneous injection
16262802|NCT00916110|Drug|ATN-103|25 mg solution, single subcutaneous injection
16262803|NCT00916110|Drug|ATN-103|25 mg solution, single intravenous injection
16262804|NCT00916110|Drug|ATN-103|50 mg solution, single subcutaneous injection
16262805|NCT00916110|Drug|ATN-103|100 mg solution, single subcutaneous injection
16262806|NCT00916110|Drug|ATN-103|200 mg solution, single subcutaneous injection
16262807|NCT00916110|Drug|ATN-103|200 mg solution, single intravenous injection
16262808|NCT00916097|Drug|DOCETAXEL(XRP6976)|docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
16262809|NCT00916084|Device|Fixed Tongue Appliance|A functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch.
16262810|NCT00916084|Device|Fixed Face Mask|An extra-oral appliance used for treatment of maxillary deficiency in growing patients. It takes anchorage from the chin and forehead, has a fixed intra-oral appliance with an expansion screw and hooks for elastics that exert a force of 300 gr. It should be used 14 hours a day.
16262811|NCT00916058|Drug|Bendamustine|30 mg/m^2 given on day 2 of melphalan
16262812|NCT00916058|Drug|Melphalan|100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min)
16262813|NCT00916058|Drug|Bendamustine|60 mg/m^2 given on the 2nd day of melphalan
16262814|NCT00916058|Drug|Bendamustine|90 mg/m^2 given on the 2nd day of melphalan
16262815|NCT00916058|Drug|Bendamustine|60 mg/m^2 given on the 1st and 2nd day of melphalan
16262816|NCT00916058|Drug|Bendamustine|90 mg/m^2 given on the 1st day of melphalan and 60 mg/m^2 given on the 2nd day of melphalan
16262817|NCT00916058|Drug|Bendamustine|125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan
16262818|NCT00916045|Drug|Thiotepa|
16262819|NCT00916045|Drug|Fludarabine|
16262820|NCT00916045|Drug|Intravenous busulphan|
16262821|NCT00916045|Drug|Thymoglobulin|
16262822|NCT00916045|Drug|Ciclosporin|
16262823|NCT00916045|Drug|Mycophenolate mofetil (MMF)|
16262824|NCT00916045|Drug|Fludarabine|
16262825|NCT00916045|Drug|Cyclophosphamide|
16262826|NCT00916045|Radiation|Radiotherapy|
16262827|NCT00916045|Drug|Thymoglobulin|
16262828|NCT00916045|Drug|Ciclosporin|
16262829|NCT00916045|Drug|Mycophenolate mofetil (MMF)|
16262830|NCT00916045|Drug|Fludarabine|
16262831|NCT00916045|Drug|Melphalan|
16262832|NCT00916045|Drug|Thymoglobulin|
16262833|NCT00916045|Drug|Ciclosporin|
16262834|NCT00916045|Drug|Mycophenolate mofetil (MMF)|
16262835|NCT00916032|Biological|Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]|Participants will receive 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence
16262839|NCT00915980|Procedure|gastric bypass surgery and testing|The patients will be tested with OGTT and meal testing before and after undergoing gastric bypass surgery.
16262840|NCT00915967|Drug|Vancomycin|Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.
16262841|NCT00915967|Drug|Placebo (Saline Solution)|Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.
16262842|NCT00915954|Diagnostic Test|Oral Glucose Tolerance Test|Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
16262843|NCT00915954|Diagnostic Test|Subcutaneous administration of recombinant human IGF-1|Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
16262844|NCT00915954|Diagnostic Test|Placebo|Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
16262845|NCT00915928|Drug|Perindopril|2,5 mg daily for 3 months
16262846|NCT00915928|Drug|Placebo|Placebo dayli for 3 months
16262847|NCT00915915|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
16262848|NCT00915915|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
16262849|NCT00915902|Drug|Omega-3-acid ethyl esters|Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks
16262850|NCT00915902|Drug|Placebo|Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
16262851|NCT00915889|Behavioral|telephone-based intervention|Either 6 or 8 telephone educational sessions
16262852|NCT00915889|Other|counseling intervention|counseling and communications studies
16262853|NCT00915889|Other|questionnaire administration|Ancillary studies
16262854|NCT00915889|Other|study of socioeconomic and demographic variables|Ancillary Studies
16262855|NCT00915889|Procedure|psychosocial assessment and care|6 weeks or 8 weeks of psychoeducational telephone sessions
16262856|NCT00915876|Drug|Paricalcitol|paricalcitol 1 mcg QD x 8 weeks
16262857|NCT00915876|Drug|Placebo|Placebo for Paricalcitol 1 mcg QD x 8 weeks
16262858|NCT00915863|Procedure|Billroth-II-type reconstruction|surgical procedure
16262859|NCT00915863|Procedure|Isolated Roux-en-Y type reconstruction|surgical procedure
16262860|NCT00915850|Drug|DCF|docetaxel, Cisplatin and 5-FU
16262861|NCT00915837|Drug|triamcinolone acetonide|Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day
16262862|NCT00915837|Drug|triamcinolone acetonide|Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day
16262863|NCT00915824|Other|STOPP/START criteria|Application of STOPP/START criteria to the patient's prescription and diagnostic information with subsequent written recommendation on pharmaceutical care to the patient's medical team
16262864|NCT00915811|Drug|Fludarabine|Fludarabine 30mg/m2 intravenously daily on days -9 to -5 inclusive of stem cell infusion.
16262865|NCT00915811|Drug|Busulphan|Busulphan 0.8mg/kg intravenously 6 hourly on days -4 and -3 of stem cell infusion.
16262866|NCT00915811|Drug|Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme|Thymoglobuline will be given intravenously over a minimum of 6 hours for the first two doses and 4 hours for the subsequent doses. Acute side effects of ATG appear to be reduced if a very low dose is given for the first injection. Thymoglobuline 0.5mg/kg iv on day -4, 1.5mg/kg/day on day -3; and 2mg/kg/day iv on day -2 to -1 inclusive.
16262867|NCT00915811|Procedure|Haematopoietic stem cell infusion|The source of stem cells will be PBSC wherever possible. Patients whose donors decline or are unable to donate PBSC will be transplanted with marrow cells.
16262868|NCT00915798|Behavioral|Cigarette smoking|Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.
16262869|NCT00915798|Behavioral|Abstinence|Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
16262870|NCT00915785|Drug|5 azacytidine|Patients will receive azacytidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment.
16262871|NCT00915772|Drug|Linagliptin + metformin|Linagliptin tablet low dose + metformin tablet 500 mg bid
16262872|NCT00915772|Drug|Linagliptin+metformin|Linagliptin low dose tablet + metformin 1000 mg tablet bid
16262873|NCT00915772|Drug|Metformin|Metformin 1000 mg tablet bid
16262874|NCT00915759|Device|ProKera|ProKera placed in non-dominant eye after PRK
16262875|NCT00915759|Device|Bandage contact lens|Bandage contact lens placed in dominant eye, the current standard after PRK
16262876|NCT00915746|Drug|JNJ-31001074; ketoconazole|
16262877|NCT00915733|Drug|cilostazol|100 mg twice daily for at least 1 month
16262878|NCT00915733|Drug|clopidogrel (Plavix)|150 mg once daily (high maintenance dose group arm), 75 mg once daily (triple group arm)
16262879|NCT00915733|Genetic|CYP2C19|CYP2C19 polymorphism study: Two CYP2C19 polymorphisms, CYP2C19*2 (rs4244285, c. 681G>A, p.P227P), and CYP2C19*3 (rs4986893, c. 636G>A, p. W212X), are investigated using the ABI SNaPshot reaction and the ABI 3100 automated genetic analyzer.
16262880|NCT00915733|Drug|aspirin (Acetylsalicylic acid)|aspirin 100 mg qd
16262881|NCT00915707|Other|Baseline|Subjects are allowed time in bed for sleep as their usual time at home.
16262882|NCT00915707|Other|Sleep restriction|Subjects sleep is reduced to 4.5 hours in bed for 4 nights.
16262883|NCT00915707|Other|Reduced Sleep Quality|Subjects sleep quality is reduced for 4 nights.
16262884|NCT00915694|Drug|nelfinavir mesylate|
16262885|NCT00915694|Drug|temozolomide|
16262886|NCT00915694|Procedure|adjuvant therapy|
16262887|NCT00915694|Radiation|radiation therapy|
16262888|NCT00915681|Drug|Silibinin|20 mg/kg/day IV
16262889|NCT00915668|Drug|JNJ-31001074|
16263150|NCT00913848|Drug|Depakote 500 mg DR Tablets (Abbott Laboratories, USA)|
16262890|NCT00915655|Drug|darunavir|Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks
16262891|NCT00915655|Drug|ritonavir|Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks
16262892|NCT00915655|Drug|zidovudine|NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
16262893|NCT00915655|Drug|lamivudine|NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
16262894|NCT00915655|Drug|abacavir|NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
16262895|NCT00915629|Dietary Supplement|Lactibiane candisis 5M|2 gelules per day for 2 months then 1 gelule per day for 4 months
16262896|NCT00915616|Drug|Melatonin|
16262897|NCT00915603|Drug|Everolimus|Everolimus 10mg PO daily continuously for all 28 days of a cycle
16262898|NCT00915603|Drug|Bevacizumab|Bevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle
16262899|NCT00915603|Drug|Paclitaxel|Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.
16262900|NCT00915603|Drug|Placebo|Placebo PO daily continuously for all 28 days of a cycle
16262901|NCT00915603|Drug|Bevacizumab|Bevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle
16262902|NCT00915603|Drug|Paclitaxel|Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.
16262903|NCT00915590|Drug|Placebo|Custom eye drop eye three times a day in both eyes for a period of 6 weeks
16262904|NCT00915590|Drug|IL-1Ra|5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
16262905|NCT00915577|Drug|Interferon beta-1a|30mcg, IM once-a-week
16262906|NCT00915577|Device|Single-use autoinjector|Single-use autoinjector with Avonex 30mcg pre-filled syringe
16262907|NCT00915564|Drug|TMC435|Participants will receive 150 mg dose of TMC435 orally (by mouth) once daily for 7 days of treatment (from Day 1 to Day 7).
16262908|NCT00915564|Other|Methadone|Participants will receive supervised individualized methadone dose (dose of methadone will be adjusted for each participant between a range of 30 and 150 mg daily [extremes included]) from Day -14 untill Day 8. Participants will continue to receive individualized methadone during follow up of 30 to 32 days.
16262909|NCT00915551|Drug|PEP005 (Ingenol Mebutate) gel, 0.015%|once daily for 3 consecutive days
16262910|NCT00915551|Drug|Vehicle Gel|once daily for 3 consecutive days
16262911|NCT00915538|Drug|pMDI budesonide/formotrol 160/4.5 is in group 1|The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.
16262912|NCT00915538|Device|Symbicort 160/4.5 plus Aerochamber Plus included in group 2|Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.
16262913|NCT00915525|Biological|botulinum toxin Type A|Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
16262914|NCT00915512|Drug|Paliperidone extended-release (ER)|Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily.
16262915|NCT00915499|Device|VPAP Adapt SV|Comparison of ASV and CPAP modes
16262916|NCT00915486|Procedure|Good Standard of Care (GSoC)|Procedural treatment twice per week
16262917|NCT00915486|Biological|Vehicle|Topical fibrin as an adjunct to GSoC twice per week
16262918|NCT00915486|Biological|I-020201|Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week
16262919|NCT00915473|Drug|bupivicaine|2.5 mL 0.5% bupivicaine
16262920|NCT00915473|Drug|normal saline|2.75 mL normal saline
16262921|NCT00915473|Drug|methylprednisolone|0.5 mL 20 mg methylprednisolone
16262922|NCT00915473|Drug|lidocaine|0.25 mL 1% lidocaine
16262923|NCT00915460|Drug|Interferon beta-1a (Avonex)|dosage and frequency as per Biogen Idec protocol
16262924|NCT00915434|Drug|JNJ-31001074|
16262925|NCT00915421|Procedure|Induction of therapeutic mild hypothermia|Rapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C
16262926|NCT00915408|Drug|Lenalidomide|Oral lenalidomide 25mg daily on Days 1-21 every 28 days cycles for up to 9 cycles. From Cycle 10 Lenalidomide 25mg orally on days 1-21, every 28 days.
16262927|NCT00915408|Drug|Dexamethasone|Dexamethasone 20mgs orally, daily on Days 1-4 and 8-11 repeated every 28 day cycles for up to 9 cycles.
16262928|NCT00915408|Drug|Cyclophosphamide|Oral Cyclophosphamide will be added to the regime starting on days 1 and 8. The dose of Cyclophosphamide will be escalated in cohorts rising in 100mg increments from 300 to 700mgs days 1,and 8 every 28 day cycles for up to 9 cycles.
16262929|NCT00915382|Drug|S-1 and cisplatin|"S-1: 80 mg/m2/day po on Days 1-14
~cisplatin: 60 mg/m2 iv on Day 1"
16262930|NCT00915382|Drug|S-1 and cisplatin|"S-1: 80 mg/day with BSA less than 1.25 m2, 100 mg/day with BSA more than 1.25 m2 and less than 1.5 m2, 120 mg/day with BSA more than 1.5 m2 on Days 1-21 and
~cisplatin: 60 mg/m2 iv on Day 1 or 8"
16262931|NCT00915369|Drug|Nanoxel (Paclitaxel Nanoparticle formulation )|Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.
16262932|NCT00915356|Drug|AZD1305|Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
16262933|NCT00915356|Drug|Placebo|iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
16262934|NCT00915343|Drug|hydrocortisone (modified release), oral tablet 20 and 5 mg|The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial
16262935|NCT00915343|Drug|Hydrocortisone, oral tablet, 10 mg|The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.
16262936|NCT00915330|Procedure|Rapid on-site cytopathologic evaluation (ROSE)|ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.
16262937|NCT00915330|Procedure|TBNA|transbronchial needle aspiration
16262938|NCT00915304|Behavioral|The EBMeDS reminders|"Phase I: EBMeDS reminders specific to the visiting or caring patient and his/her clinical problem are generated when the practitioner uses the electronic patient record. During visits of intervention group patients the EBMeDS reminders will be shown on screen to the practitioner.
~Phase II: As phase I and in addition, results of the Virtual Health Check (VHC) of all the intervention group patients will be shown to the practitioners.Phase II will be fulfilled in Autumn 2010 and follow-up time will be about 3 months."
16262939|NCT00915291|Other|Web-based educational modules|Interactive case-based modules that includes video vignettes of clinical interactions between hypothetical patients interacting with physicians
16262940|NCT00915278|Drug|PF-04605412|PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal
16262941|NCT00915265|Other|Multilobed catheter (group CPA)|- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia
16262942|NCT00915265|Other|Multilobed catheter (group EA)|EA group : thoracic epidural infusion of 0.2 % ropivacaine
16262943|NCT00915252|Drug|azacitidine|"Starting dose has been determined during run-in dose finding part of the study. Starting dose of the interventional drug is 75 mg/m²/d. Application form:
~During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles).
~During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy."
16262944|NCT00915252|Drug|standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine|"Induction therapy:
~Daunorubicin 60mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7
~Consolidation therapy:
~AraC 1g/m² twice a day on day 1,3,5"
16262945|NCT00915239|Drug|Pantoprazole|40 mg pantoprazole once daily for 28 days
16262946|NCT00915239|Drug|Placebo|identical placebo once daily for 28 days
16262947|NCT00915226|Procedure|Suction cup application|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
16262948|NCT00915226|Procedure|Squatting|Squatting
16262949|NCT00915200|Dietary Supplement|N-acetylcysteine|600 mg orally twice daily for three months
16262950|NCT00915200|Dietary Supplement|silibin|480 mg orally twice daily for three months
16262951|NCT00915200|Dietary Supplement|high-dose silibin|960 mg orally twice daily for three months
16262952|NCT00915200|Dietary Supplement|N-acetylcysteine placebo|excipient orally twice daily for three months
16262953|NCT00915200|Dietary Supplement|silibin placebo|excipient orally twice daily for three months
16262954|NCT00915187|Drug|CCS/C|Adjuvant to influenza vaccine
16262955|NCT00915187|Biological|Influenza Vaccine|Influenza vaccine
16262956|NCT00915174|Drug|Neramexane|25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days
16262957|NCT00915148|Other|Ultrasound examination|Trans-abdominal and trans-perineal 3D ultrasound examination
16262958|NCT00915135|Drug|Ramelteon and Placebo (25 possible combinations total)|"Randomized sequence over two consecutive nights for a total of five treatment periods to include the following:
~Ramelteon 4 mg, tablets, orally over two nights
~Ramelteon 8 mg, tablets, orally over two nights
~Ramelteon 16 mg, tablets, orally over two nights
~Ramelteon 32 mg, tablets, orally over two nights
~Ramelteon placebo-matching tablets, orally over two nights"
16262959|NCT00915122|Radiation|Dose Escalated IMRT|Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.
16262960|NCT00915083|Drug|Amrubicin|40mg/m^2 5 minute IV infusion for 3 consecutive days (21 day cycle)
16262961|NCT00915070|Drug|BQ-123|60 mcg/min, infusion period: 60 min
16262962|NCT00915070|Drug|Physiological saline solution|infusion period 60 minutes
16262963|NCT00915070|Device|Laser Doppler Flowmetry|blood flow measurements at the temporal neuroretinal rim to assess optic nerve head blood flow
16262964|NCT00915070|Device|Goldmann Applanation Tonometer|intraocular pressure measurements
16262965|NCT00915070|Other|squatting|subjects will perform squatting for 6 minutes while blood flow measurements
16262966|NCT00915057|Drug|NRL972|Single dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment.
16262967|NCT00915031|Device|UroCool|Hypothermia Endorectal Device
16262968|NCT00915018|Drug|Neratinib|Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
16262969|NCT00915018|Drug|Trastuzumab|Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
16262970|NCT00915018|Drug|Paclitaxel|Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
16262971|NCT00915005|Radiation|Photon Therapy|Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.
16262972|NCT00915005|Radiation|Proton Therapy|"Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks.
~Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks.
~Each daily treatment should take about 20-30 minutes to complete."
16262973|NCT00915005|Drug|Paclitaxel|50 mg/m2 by vein 1 time each week for 7 weeks.
16262975|NCT00914992|Procedure|Suction cup application|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
16262976|NCT00914992|Other|Squatting|Squatting
16262977|NCT00914979|Device|AngioSculpt|The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip
16262978|NCT00914966|Biological|C1 inhibitor (human) [C1 INH]|
16262979|NCT00914953|Drug|oxytocin (Pitocin)|40 IU OT intranasally (IN) once-daily for 10 consecutive days
16262980|NCT00914940|Drug|Fludarabine Phosphate|Fludarabine will be administered in a dose of 25 mg/m2/day IV over approximately 30 minutes for 5 consecutive days (day -6 to -2). The total dose of fludarabine will be 125 mg/m2.
16262981|NCT00914940|Drug|Tacrolimus|"Tacrolimus will be administered beginning on day -1 at a dose of 0.03 mg/kg/day by continuous IV infusion.
~For the first cohort of 35 patients, if there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus should then be tapered at the rate of approximately 5% of the day 50 dose each week for liquid, and 20% of the day 50 dose per month for capsules.
~In the second cohort of 25 patients if there is no evidence of grade II GVHD on or prior to day 30, tacrolimus should then be tapered at the rate of approximately 8% of the day 30 dose each week for liquid, and 33% of the day 30 dose per month for capsules."
16262982|NCT00914940|Drug|Thiotepa|Thiotepa will be administered in a dose of 5 mg/kg/day (adjusted body weight) IV over approximately 4 hours for 2 consecutive days (day -6 and day -5).
16262983|NCT00914940|Radiation|Total-Body Irradiation (TBI)|TBI will be given as 165 cGy fractions twice per day x 4 days - total dose 1320cGy (days -10 to -7).
16262984|NCT00914940|Other|Magnetic Affinity Cell Sorting|Device
16262985|NCT00914940|Procedure|Peripheral Blood Stem Cell Transplantation|Patient will undergo a PBSC transplantation
16262986|NCT00914940|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation
16262987|NCT00914940|Biological|T Cell-Depleted Hematopoietic Stem Cell Transplantation|Patients who are eligible will receive a T Cell-Depleted Hematopoietic Stem Cell Transplantation
16262988|NCT00914927|Drug|Avatrombopag|Avatrombopag first Dose 80 mg followed by 10 mg a day for up to 6 additional days
16262989|NCT00914927|Drug|Avatrombopag|Avatrombopag first Dose 80 mg followed by 20 mg a day for 3 days and then Placebo for 3 additional days
16262990|NCT00914927|Drug|Placebo|Placebo or inactive substance once a day for up to 7 days
16262991|NCT00914914|Drug|p28|p28 will be dissolved in normal saline and infused intravenously into the patient over 15-30 minutes.
16262992|NCT00914901|Drug|inhaled salmeterol|Inhalation of 100 micrograms salmeterol in one dose.
16262993|NCT00914888|Drug|Tigecycline|"Subject with cIAI:
~Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered."
16262994|NCT00914888|Drug|Tigecycline|"Subject with CAP:
~IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h.
~Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old)."
16262995|NCT00914888|Drug|cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside|"Subject with cIAI:
~Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours.
~In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given."
16262996|NCT00914888|Drug|CAP: Ceftriaxone, plus if applicable oral clarithromycin|"Subject with CAP:
~IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).
~Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old)."
16262997|NCT00914862|Drug|Ramelteon|Ramelteon tablets, orally for one day only.
16262998|NCT00914849|Drug|AMD3100|
16262999|NCT00914849|Procedure|Leukopheresis|
16263000|NCT00914849|Procedure|Stem cell transplant|
16263001|NCT00914836|Drug|Betamethasone Sodium Phosphate|1cc:2cc
16263002|NCT00914836|Drug|1 cc - Betamethasone Sodium Phosphate|Betamethasone Sodium Phosphate
16263003|NCT00914836|Drug|2 cc - Betamethasone Sodium Phosphate|Betamethasone Sodium Phosphate
16263004|NCT00914823|Drug|kisspeptin 112-121|one or more intravenous or subcutaneous doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121
16263005|NCT00914823|Drug|GnRH|One or more intravenous doses of GnRH
16263006|NCT00914810|Dietary Supplement|Vitamin D (cholecalciferol)|2000 I.U. daily for 6 weeks
16263007|NCT00914810|Dietary Supplement|Placebo|Placebo (sugar pill) daily for 6 weeks
16263008|NCT00914797|Drug|inhaled and oral terbutaline|"Inhalation of 2 mg terbutaline as powder as a single dosage. Oral terbutaline 10 mg as a single dosage.
~Inhaled: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076.
~Oral: Tablet Bricanyl Retard 5 mg, MA no. 10954."
16263009|NCT00914771|Biological|H5N1 pandemic Influenza vaccine 3.75µg|2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen
16263010|NCT00914771|Biological|H5N1 pandemic Influenza vaccine 7.5µg|2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen
16263011|NCT00914745|Drug|Ointment|Each time about 1.5 cm ointment have to be applied on the upper lip and 1.5 cm on the lower lip, twice daily for prophylaxis for e period of 6 month.
16263012|NCT00914732|Biological|MVA Smallpox Vaccine|Vaccinia vaccine liquid formulation delivered by subcutaneous (SC) route at 1x10^8 TCID50 per 0.5 mL dose on Days 0 and 28.
16263013|NCT00914732|Biological|MVA Smallpox Vaccine|Vaccinia vaccine liquid formulation delivered at lower dose [2x10^7 tissue culture infectious dose 50 (TCID50) per 0.1 mL dose] by intradermal (ID) route on Days 0 and 28.
16263014|NCT00914732|Biological|MVA Smallpox Vaccine|Vaccinia vaccine lyophilized formulation delivered by subcutaneous (SC) route at 1x10^8 TCID50 per 0.5 mL dose on Days 0 and 28.
16263015|NCT00914719|Behavioral|Information only|
16263016|NCT00914719|Behavioral|Sexual risk reduction intervention|
16263017|NCT00914719|Behavioral|sexual risk reduction + alcohol risk reduction component|
16263018|NCT00914706|Other|P-PROMPT|P-PROMPT is a web-based chronic disease management system. The system will help to ensure that all patients have up-to-date laboratory monitoring and visits as recommended by the Canadian Diabetes Association Guidelines.
16263019|NCT00914693|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
16263020|NCT00914680|Procedure|magnetic seizure therapy|antidepressant treatment with MST
16263021|NCT00914667|Drug|warfarin|Single Dose Warfarin 25 mg on Day 1
16263022|NCT00914667|Drug|Warfarin plus Fesoterodine|Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3
16263023|NCT00914654|Drug|inhaled formoterol|Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.
16263024|NCT00914641|Drug|Apixaban IR|immediate release tablet, 10 mg, single dose
16263025|NCT00914641|Drug|Apixaban MR1|modified release tablet 1, 10 mg, single dose
16263026|NCT00914641|Drug|Apixaban MR2|modified release tablet 2, 10 mg, single dose
16263027|NCT00914641|Drug|Apixaban MR3|modified release tablet 3, 10 mg, single dose
16263028|NCT00914628|Genetic|HSV-Tk|Infusion of approximately 1±0.2 x 10^7 HSV-Tk genetically modified CD3+ cells/Kg between day +21 and day +49 after haploidentical HCT; in absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
16263029|NCT00914628|Other|T-cell depleted or T-cell replete strategies|Haploidentical HCT with the infusion of CD34+ cells plus a fixed dose of T cells (1 x 10^4/Kg) or unmanipulated haploidentical stem cell transplantation followed by high-dose cyclophosphamide as part of GvHD prophylaxis
16263030|NCT00914615|Radiation|Stereotactic Body Radiation|Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver (up to an hour including all imaging and set-up procedures). You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment. Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.
16263031|NCT00914602|Drug|Sinemet 25-100 Oral Tablet|After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.
16263032|NCT00914602|Drug|XP21279|Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).
16263033|NCT00914602|Drug|Carbidopa Pill|
16263034|NCT00914589|Drug|catridecacog|Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
16263035|NCT00914589|Drug|catridecacog|Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
16263036|NCT00914589|Drug|placebo|Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
16263037|NCT00914576|Drug|Vitamin and mineral supplement|1 capsule/day in the morning for 14 days, containing: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, Ginko Biloba 10mg, Flavonoids 25mg, Fish oil 300mg
16263038|NCT00914576|Drug|Vitamin and mineral supplement|1 capsule/day in the evening for 14 days, containing: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selene 20µg, Ginko Biloba 10mg, Flavonoids 25mg, Alpha Lipon acid: 150mg
16263039|NCT00914576|Drug|Placebo|2 capsules/day for 14 days
16263040|NCT00914576|Drug|100% Oxygen|breathing of 100% O2 for 30 minutes on both study days
16263041|NCT00914576|Drug|Escherichia coli Endotoxin|Escherichia coli Endotoxin (LPS, US Standard Reference Endotoxin, dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.
16263042|NCT00914563|Device|LIDCO Lithium Dilution Cardiac Output|Lithium Dilution Cardiac Output (LIDCO) Plus permits through analysis of the arterial blood pressure trace to acquire items about CO, SVR and DO2.
16263043|NCT00914563|Other|Standard Care|We will compare the standard monitored and volume resuscitated group of patients with the LIDCO monitored group. The control group will be composed of the patients supervised in a standard way, volume resuscitated according to the Brooke or Parkland formulas.
16263044|NCT00914550|Other|Procalcitonin level, caregiver informed|Procalcitonin levels will be measured and known by investigator, only 1/2 of the patients' caregivers will know the results of serial Procalcitonin levels. We will analyze the rate of antibiotic discontinuation for the two arms
16263045|NCT00914524|Drug|olmesartan medoxomil|olmesartan medoxomil tablets, once daily
16263046|NCT00914511|Drug|avanafil 200mg|single dose tablet of 200mg avanafil
16263047|NCT00914511|Drug|avanafil 200mg|single tablet dose of 200mg avanafil
16263048|NCT00914498|Drug|Local, pre-incisional injection of 20 ml 1% xylocaine|Local, pre-incisional injection of 20 ml 1% xylocaine
16263049|NCT00914485|Behavioral|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
16263050|NCT00914472|Biological|heparin sodium - APP|Heparin 5000 IU / mL
16263051|NCT00914472|Biological|Heparin sodium - Hipolabor|Heparin 5000 IU / mL
16263052|NCT00914459|Biological|Moroctocog alfa ( AF-CC)|Dosing is at the discretion of the Investigator
16263053|NCT00914459|Procedure|Laboratory tests|Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody
16263054|NCT00914446|Procedure|hepatic biopsies|hepatic biopsies
16263055|NCT00914433|Drug|TPI 1100|1 dose only increasing dose
16264637|NCT00902486|Drug|INCB028050|7 mg capsules QD
16263056|NCT00914420|Device|Intrepide Trapidil eluting stent|"The INTREPIDE coronary stent system consists of a balloon expandable stent coated with two layers of Trapidil and parylene. The Trapidil eluting stent is pre-mounted on a Nimbus PCTA balloon and is intended for use in the treatment of CAD.
~The controlled release of Trapidil is achieved through the parylene barrier, locally delivering the drug to the target lesion, inhibiting smooth muscle cell proliferation and hence neointimal hyperplasia."
16263057|NCT00914420|Device|Taxus drug eluting stent|Paclitaxel Drug eluting stent manufactured by Boston Scientific
16263058|NCT00914407|Drug|Oxygen|100% Oxygen inhalation for 30 minutes
16263059|NCT00914394|Drug|NG-monomethyl-L-arginine (L-NMMA)|bolus 6mg/kg over 5 minutes followed by a continuous infusion of 60µg/kg/min over 15 minutes
16263060|NCT00914394|Drug|Phenylephrine|1µg/kg/min, infusion period 20 minutes
16263061|NCT00914394|Drug|Physiological saline solution (as placebo)|infusion period 20 minutes
16263062|NCT00914394|Device|Laser Doppler Flowmetry|Measurements will be performed at the neuroretinal rim to assess ONH blood flow.
16263063|NCT00914394|Device|Goldmann applanation tonometer|intraocular pressure measurements
16263064|NCT00914394|Device|Suction cup|Experimental stepwise increase of intraocular pressure while measurement of optic nerve head blood flow.
16263065|NCT00914381|Behavioral|Behavioral therapy|
16263066|NCT00914368|Drug|Clopidogrel|Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.
16263067|NCT00914355|Radiation|Stereotactic Body Radiation|Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver.You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment.Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.
16263068|NCT00914329|Drug|Gelsemium Sempervirens|5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
16263069|NCT00914329|Drug|Gelsemium Sempervirens|15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
16263070|NCT00914329|Drug|Placebo|placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
16263071|NCT00914316|Drug|Ranolazine|Ranolazine, 1000 mg, capsule, twice daily, by mouth.
16263072|NCT00914316|Drug|Placebo|twice daily
16263073|NCT00914303|Drug|AZD3241|Oral Tablet, Repeated Administration
16263074|NCT00914303|Drug|Placebo Tablet|Oral Tablet. Repeated Administration
16263075|NCT00914290|Drug|IPX056|IPX056 ER capsule containing 10 mg baclofen
16263076|NCT00914290|Drug|Baclofen IR|Encapsulated baclofen tablet 5 mg per capsule
16263077|NCT00914290|Drug|Placebo IPX056|Placebo capsule for IPX056
16263078|NCT00914290|Drug|Placebo IR|Placebo encapsulated baclofen placebo tablet
16263079|NCT00914277|Drug|SAR407899|Oral administration
16263080|NCT00914277|Drug|Placebo|Oral administration
16263081|NCT00914277|Drug|Sildenafil|Oral administration
16263082|NCT00914264|Device|continuous positive airway pressure|CPAP with adequate pressure for 1 day, 3 & 12 months
16263083|NCT00914251|Drug|Hesperidin|Administration of oral Hesperidin, 500 mg/daily
16263084|NCT00914251|Drug|Placebo|Administration of oral Placebo, 500 mg/daily
16263085|NCT00914238|Behavioral|2 years OPUS treatment|2 years OPUS and transfer to standard treatment.
16263086|NCT00914238|Behavioral|OPUS 5 years|
16263087|NCT00914225|Other|Bednets and Water Purification|Individuals in the intervention cohort will be provided with a LLIN and water filtration device. Subjects are followed for 24 months and have serial measurements of HIV disease progression. Data are collected every 3 months on the frequency of malaria, diarrhea and other co-morbidities, as well as compliance with LLIN and water filter use.
16263088|NCT00914212|Drug|Placebo|Single dose placebo to sibutramine in two of three treatment periods.
16263089|NCT00914212|Drug|Comparator: sibutramine|Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.
16263090|NCT00914199|Procedure|Percutaneous coronary intervention (PCI)|Implantation of coronary stent in bifurcation lesion.
16263091|NCT00914186|Drug|TS022|Lotion
16263092|NCT00914186|Drug|Vehicle|Lotion
16263093|NCT00914173|Device|Scanlaf Circulator and water bath|Cold Pressor Test
16263094|NCT00914173|Device|Medoc TSA 2000|Thermal stimuli pain
16263095|NCT00914160|Drug|Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)|
16263096|NCT00914160|Drug|Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)|
16263097|NCT00914160|Drug|Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)|
16263098|NCT00914147|Procedure|pulmonary function testing|After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization.
16263099|NCT00914134|Drug|Levodopa infusion|Naso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose.
16263100|NCT00914121|Drug|SKI-606|
16263101|NCT00914121|Drug|Placebo|
16263102|NCT00914121|Drug|Moxifloxacin|
16263151|NCT00913835|Biological|Olaratumab|20 milligrams per kilogram (mg/kg) administered by intervenous (IV) infusion every 2 weeks (14 days). Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity
16263152|NCT00913835|Drug|liposomal doxorubicin|40 milligrams per square meter (mg/m²) administered according to the manufacture's instructions every 4 weeks (28 days). Treatment will continue until there is evidence of PD or development of unacceptable toxicity
16263153|NCT00913822|Drug|Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)|
16263154|NCT00913822|Drug|Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)|
16263155|NCT00913809|Drug|Desipramine HCL 100 mg Tablets Cord Laboratories|
16263103|NCT00914108|Behavioral|Newborn Individualized Developmental Care|The developmental care model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists observed each infant's behavior throughout hospitalization and to 2 weeks corrected age and formulated descriptive neurobehavioral reports with suggestions to structure caregiving procedures adapted to the infant's sleep/wake cycle and in support of the infant's well-regulated behavioral balance. Parents were supported to care for their infant, encouraged to nurse and hold their infant skin-to-skin, and to cradle them during stressful procedures.
16263104|NCT00914095|Drug|methylphenidate|10 mg tablet of methylphenidate 3 times a day (1 mg/kg/day)
16263105|NCT00914095|Drug|placebo|tablets of placebo 3 times a day
16263106|NCT00914082|Behavioral|Self hypnosis|3 antenatal classes of 1 hour. 3 audio compact discs for reenforcement. 1 audio compact discs for support at birth
16263107|NCT00914069|Device|RIVS vascular access|Access to peripheral vasculature
16263108|NCT00914069|Device|Conventional vascular access|Vascular access using conventional venous access device
16263109|NCT00914056|Drug|lactulose|withdrawal of lactulose
16263110|NCT00914043|Genetic|gene expression analysis|
16263111|NCT00914043|Genetic|microarray analysis|
16263112|NCT00914043|Genetic|polymerase chain reaction|
16263113|NCT00914043|Genetic|polymorphism analysis|
16263114|NCT00914043|Genetic|reverse transcriptase-polymerase chain reaction|
16263115|NCT00914043|Other|biologic sample preservation procedure|
16263116|NCT00914043|Other|enzyme-linked immunosorbent assay|
16263117|NCT00914043|Other|laboratory biomarker analysis|
16263118|NCT00914043|Procedure|fatigue assessment and management|
16263119|NCT00914030|Other|Neuropsychological evaluation|Study one: global/local processing, with a neutral prime (stimulus influencing the processing of the subsequent stimulus)Study two: global/ local processing with a prime whose elements are collinear.Study three: global/local processing with a prime whose elements are not collinear
16263120|NCT00914017|Drug|Atorvastatin|Atorvastatin, 40 mg daily for 1 year
16263121|NCT00914017|Drug|Placebo|sugar pill daily for 1 year
16263122|NCT00914004|Drug|Desipramine HCl 50 mg Tablets Cord Laboratories|
16263123|NCT00914004|Drug|Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc|
16263124|NCT00913991|Behavioral|Stress Management Training|Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.
16263125|NCT00913991|Behavioral|Stress Management Training|Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.
16263126|NCT00913978|Device|Group 1: VitaHeat|Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
16263127|NCT00913978|Device|Group 2: Bair Hugger|Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
16263128|NCT00913965|Drug|Atenolol Tablets 100 mg (Cord Laboratories)|
16263129|NCT00913965|Drug|Atenolol Tablets 100 mg (Stuart Pharmaceutical)|
16263130|NCT00913952|Drug|Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions|
16263131|NCT00913952|Drug|Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions|
16263132|NCT00913952|Drug|Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions|
16263133|NCT00913939|Procedure|MRI Guided Needles to deliver HDR Brachytherapy|Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).
16263134|NCT00913939|Procedure|MRI Guided Needles to deliver HDR Brachytherapy|Patients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT.
16263135|NCT00913926|Drug|E2/LNG oral (Wellnara, BAY86-5029)|Patients in daily life treatment receiving Wellnara according to local drug information.
16263136|NCT00913913|Biological|DC vaccine|DC Vaccine therapy 10E7 intranodally every cycle
16263137|NCT00913913|Drug|Bevacizumab|Bevacizumab 10mg/kg iv every 2 weeks
16263138|NCT00913913|Biological|IL-2|IL-2 18 MiU/m2 CI 5 days
16263139|NCT00913913|Biological|IFN|IFN 6 MiU subc TIW
16263140|NCT00913900|Biological|autologous CD133+ cells|Intramuscular injection
16263141|NCT00913887|Drug|Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)|
16263142|NCT00913887|Drug|Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)|
16263143|NCT00913887|Drug|Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)|
16263144|NCT00913874|Drug|Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)|
16263145|NCT00913874|Drug|Depakote 500 mg DR Tablets (Abbott Laboratories, USA)|
16263146|NCT00913861|Behavioral|hypnosis|Hypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation.
16263147|NCT00913861|Drug|standard sedation|Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
16263148|NCT00913861|Behavioral|Structured attention|Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.
16263156|NCT00913809|Drug|Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc|
16263157|NCT00913796|Drug|Potassium citrate|2.41 gram of citrate b.i.d. for 12 months. Dosage to be adjusted according to serum potassium concentration.
16263158|NCT00913796|Drug|Potassium chloride|370 mg potassium t.i.d. for 12 months. Dosage to be adjusted according to serum postassium concentration.
16263159|NCT00913783|Drug|Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)|
16263160|NCT00913783|Drug|Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)|
16263161|NCT00913770|Behavioral|Brief Negotiation Interview (BNI)|Brief Negotiation Interview (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program.
16263162|NCT00913770|Drug|Buprenorphine Initiation|
16263163|NCT00913744|Drug|Ocriplasmin|ocriplasmin intravitreal injection (125 µg)
16263164|NCT00913744|Drug|Sham injection|Sham injection
16263165|NCT00913718|Drug|Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)|
16263166|NCT00913718|Drug|Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)|
16263167|NCT00913705|Drug|Neoadjuvant chemotherapy (taxol and carboplatin)|Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21-day intervals. Prior to surgery.
16263168|NCT00913705|Drug|Adjuvant chemotherapy (taxol and carboplatin)|Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21 days interval. Post-surgery
16263169|NCT00913705|Procedure|Surgery|Surgery
16263170|NCT00913692|Drug|Glutamine|Subjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months.
16263171|NCT00913692|Drug|Glycine|Subjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months.
16263172|NCT00913679|Procedure|Surgical approach (ReCap Hip Resurfacing System)|two different surgical approaches in hip resurfacing arthroplasty
16263173|NCT00913666|Drug|Interferon beta-1a (Avonex)|30 mcg by intramuscular injection once a week
16263174|NCT00913653|Drug|LCZ696|
16263175|NCT00913627|Drug|ibuprofen|
16263176|NCT00913627|Drug|ibuprofen|
16263177|NCT00913627|Drug|naproxen|
16263178|NCT00913627|Drug|Placebo|
16263179|NCT00913614|Drug|Eplivanserin (SR46349)|Oral administration
16263180|NCT00913601|Device|Medtronic INTERSIM II - 3058|Medtronic INTERSIM II - 3058 Impuls Generator
16263181|NCT00913588|Drug|Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)|
16263182|NCT00913588|Drug|Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)|
16263183|NCT00913588|Drug|Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)|
16263184|NCT00913575|Other|preoperative neuromuscular training|The neuromuscular training group will receive a minimum of 8 and a maximum of 24 training sessions; as well as 4 sessions of the Knee OA School.
16263185|NCT00913575|Behavioral|knee OA School|The education group will only receive 4 sessions of the Knee OA School.
16263186|NCT00913562|Drug|Rosuvastatin|one tablet rosuvastatin 10 mg per day for 12 weeks
16263187|NCT00913562|Drug|Placebo|one tablet a day for 12 weeks
16263188|NCT00913549|Drug|Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)|
16263189|NCT00913549|Drug|Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)|
16263190|NCT00913536|Other|Using Cone beam CT in patients with Bladder Cancer|Using cone beam CT scanner will help to increase the accuracy of your radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit.
16263191|NCT00913523|Device|Experimental - Tampon with GML|Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover
16263192|NCT00913523|Device|Sham Control - Tampons without GML|There is no intervention associated with these arms - they are sham controls.
16263193|NCT00913510|Device|CIC using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
16263194|NCT00913510|Drug|Anticholinergic medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.
16263195|NCT00913497|Drug|insulin glulisine|Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days
16263196|NCT00913497|Drug|insulin aspart|Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
16263197|NCT00913484|Drug|Disulfiram|Disulfiram 250 mg per day
16263198|NCT00913484|Drug|Placebo|Placebo daily
16263199|NCT00913471|Other|blood samples|"Chronic patients - a one time blood sample (12 mL) and questionnaire; 10 subjects will donate a 3-5mm skin tissue sample.
~Longitudinal Patients - 5 blood samples (12 mL each, totaling 60 mL at the following time points: within 48 hours, one week, one month, 6 months and 18 months post injury to coincide with standard visits) and questionnaire. 10 subjects will donate a 3-5mm skin sample.
~Healthy, pain free volunteers - a one time blood sample (12 mL), vital signs per standard CRU protocol and questionnaire confirming they are healthy."
16263200|NCT00913458|Drug|etanercept|
16263201|NCT00913445|Procedure|appendicectomy|Wound healing after absorbable and nonabsorbable stitches are compared
16263202|NCT00913432|Drug|masitinib|3 mg/kg/day oral route
16263203|NCT00913432|Drug|masitinib|masitinib 6 mg/kg/day oral route
16263204|NCT00913419|Drug|Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories|
16263205|NCT00913419|Drug|Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme|
16263206|NCT00913406|Other|Lutein fortification|
16263207|NCT00913406|Other|Standard formula|
16263208|NCT00913393|Drug|FG-3019|3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
16263209|NCT00913393|Drug|FG-3019|10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
16263210|NCT00913393|Drug|Placebo|Placebo IV every 2 weeks for 22 weeks
16263211|NCT00913380|Radiation|Diagnostic CT|2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
16263212|NCT00913380|Radiation|Diagnostic CT|8 mSv in an average patient (Standard-dose CT)
16263213|NCT00913367|Drug|glimepiride + insulin glargine (Amaryl + Lantus)|"Amaryl® 4 mg at breakfast + Lantus® at dinner
~The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast"
16263214|NCT00913367|Drug|glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)|"Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner
~The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast"
16263215|NCT00913354|Device|Acupuncture (Carbo®)|The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
16263216|NCT00913354|Device|Placebo acupuncture (Strietberger®)|"The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
~Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger."
16263217|NCT00913341|Drug|Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)|
16263218|NCT00913341|Drug|Alprazolam Tablets, 1 mg (The Upjohn Company)|
16263219|NCT00913328|Drug|Montelukast (Singulair)|10 mg tablet once daily
16263220|NCT00913328|Drug|Placebo|Oral placebo once daily
16263221|NCT00913315|Drug|tolterodine|4 mg of tolterodine ER
16263222|NCT00913315|Drug|tamsulosin|0.4 mg of tamsulosin once a day for 8 weeks
16263223|NCT00913315|Drug|placebo|placebo once a day for 8 weeks
16263224|NCT00913302|Behavioral|Cardiovascular Training|cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks
16263225|NCT00913289|Biological|adipose tissue derived stromal cells|dosage
16263226|NCT00913276|Drug|Propofol|
16263227|NCT00913276|Drug|Sevoflurane|
16263228|NCT00913263|Drug|2-hydroxyflutamide (2-HOF) [Liproca Depot]|Ready made paste including 600 mg 2-HOF for injection as a single dose
16263229|NCT00913263|Drug|2-Hydroxyflutamide|The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.
16263230|NCT00913250|Drug|Serum containing Avonex|60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15
16263231|NCT00913250|Drug|Serum Free Avonex|60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.
16263232|NCT00913237|Drug|Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)|
16263233|NCT00913237|Drug|Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)|
16263234|NCT00913224|Drug|Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)|
16263235|NCT00913224|Drug|Voltaren 50 mg Tablets (Geigy Pharmaceuticals)|
16263236|NCT00913211|Device|rTMS|600 pulses of 6 hz priming rTMS at 90% of threshold followed by 600 pulses of low-frequency rTMS at 90% of threshold.
16263237|NCT00913211|Procedure|Motor learning training|one hour of repeated finger tracking movements toward a changing target.
16263238|NCT00913211|Procedure|rTMS and Tracking|Combination of rTMS and finger tracking
16263239|NCT00913211|Device|Sham rTMS|Sham treatment of rTMS
16263240|NCT00913198|Drug|IV CP-4126|1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16263241|NCT00913185|Drug|Acne Free, Proactiv|
16263242|NCT00913172|Other|Treatment|Directly observed treatment (DOT) by health extension workers (HEWs)
16263243|NCT00913159|Procedure|Extracorporeal Shock Wave Lithotripsy (ESWL)|Using electric shock wave to treat urolithiasis
16263244|NCT00913133|Drug|Desirudin|Desirudin SC 15mg q12h
16263245|NCT00913120|Drug|YM150|oral
16263246|NCT00913120|Drug|Placebo|oral
16263247|NCT00913120|Drug|Enoxaparin|injection
16263248|NCT00913107|Drug|Lamictal®|"The regime of prescription for Lamictal® during the clinical trials was as follows:
~50 mg twice daily for 10days, followed by,
~100 mg twice daily for the next 10days, followed by,
~100 mg thrice daily for the next10 days, followed by,
~100 mg four times daily for the final 10 days."
16263249|NCT00913107|Drug|Tegretol®|"The regime of prescription for Tegretol® during the clinical trials was as follows:
~150 mg twice daily for 10days, followed by,
~200 mg thrice daily for the next 10days, followed by,
~300 mg thrice daily for the next 10 days, followed by,
~300 mg four times daily for the final 10 days."
16263250|NCT00913081|Dietary Supplement|Quercetin|Quercetin 500, 1000, or 2000 mg PO one time
16263251|NCT00913081|Dietary Supplement|Placebo|Placebo PO one time
16263252|NCT00913068|Procedure|Transverse Abdominal Plan (TAP)|An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
16263253|NCT00913068|Procedure|standard post op pain control|opiates
16263254|NCT00913055|Drug|octreotide acetate|subcutaneous implant
16263255|NCT00913042|Other|sample blood|"Early culture
~Bacterial DNA tests in blood"
16263256|NCT00913029|Device|iStent|iStent
16263257|NCT00913029|Drug|latanoprost/timolol|Combination latanoprost/timolol
16263258|NCT00913003|Drug|Lidocaine|Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)
16263259|NCT00913003|Drug|Placebo|Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug
16263260|NCT00912990|Drug|Cisatracurium|One intravenous dose: 0.2mg/kg/dose
16263261|NCT00912990|Drug|Normal saline|One Intravenous dose
16263262|NCT00912964|Drug|Mirabegron|Mirabegron tablets
16263264|NCT00912938|Drug|zoledronic acid|Intravenous zoledronic acid 4mg over a minimum of 15 minutes in at least 100mls of calcium free infusion solution (0.9% sodium chloride or 5% glucose solution) every 4 weeks.
16263265|NCT00912925|Biological|rhIDU (recombinant human-Alpha-L-Iduronidase)|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 units/kg (approximately 0.58mg/kg) administered intravenously over approximately 4 hours once weekly for 26 weeks.
16263266|NCT00912925|Biological|Placebo|Patients in the Placebo-control group were administered a solution of 100mM sodium phosphate , 150mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over a time period of approximately 4 hours once weekly for 26 weeks.
16263267|NCT00912912|Drug|Sunitinib Malate|50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
16263268|NCT00912899|Drug|Noscapine HCl|Escalating doses given twice per day
16263269|NCT00912873|Drug|0.1% Ropivacaine|Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
16263270|NCT00912873|Drug|0.4% Ropivacaine|Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
16263271|NCT00912860|Drug|Interferon beta-1a|serum free Avonex given IM once a week
16263272|NCT00912821|Drug|6 L dialysate|6 L peritoneal dialysis solution
16263273|NCT00912821|Drug|8 L dialysate|8 L peritoneal dialysis solution
16263274|NCT00912808|Drug|Donepezil|donepezil, 5 mg, capsule, once a day, 3 weeks
16263275|NCT00912808|Drug|Sugar Pill (placebo)|sugar pill, one capsule, once a day, 3 weeks
16263276|NCT00912795|Behavioral|SMS Turkey|"6-week smoking cessation program delivered via daily text messages
~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
~Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
16263277|NCT00912782|Drug|Vitamin D3|Vitamin D3 200,000 IU once a week for 3 weeks
16263278|NCT00912782|Drug|Placebo|Placebo one time per week for 3 weeks
16263279|NCT00912756|Drug|cilostazol|200 mg/day BID
16263280|NCT00912743|Drug|olaparib|400 mg po bid continuously
16263281|NCT00912691|Drug|CM-AT|Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
16263282|NCT00912678|Drug|MMF (Cellcept) and Steroids|Prograf was withdrawn completely after randomization, MMF and steroids were given.
16263283|NCT00912678|Drug|Tacrolimus (Prograf)|After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.
16263284|NCT00912665|Device|Laser Doppler Flowmetry|blood flow measurements at the temporal neuroretinal rim to assess optic nerve head blood flow
16263285|NCT00912665|Device|Goldmann applanation tonometer|intraocular pressure measurements
16263286|NCT00912665|Other|squatting|Subjects will perform squatting for 6 minutes while either blood flow or intraocular pressure measurements
16263287|NCT00912665|Device|Suction cup|Experimental stepwise increase of intraocular pressure while either optic nerve head blood flow or intraocular pressure measurements
16263288|NCT00912652|Behavioral|lifestyle intervention|Three doses of lifestyle intervention will be compared to an education control condition.
16263289|NCT00912652|Behavioral|Health Education Control|Health education control group will receive 16 session of health education related to diet and exercise over a two-year period.
16263290|NCT00912639|Drug|Paclitaxel loaded Polymeric micelle|Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
16263291|NCT00912626|Behavioral|One week follow up assessment results|FU-1 feedback group will receive child behavior assessment results and interpretation,and a brief intervention to encourage support options.
16263292|NCT00912613|Other|ICU Diary|ICU Diary containing daily information of patients condition and treatment with appropriate photographs
16263293|NCT00912600|Other|Intensive Care Unit admission|Intensive Care Unit admission
16263294|NCT00912587|Drug|ghrelin|0.1 microgram/kg/min, intravenous for 60 minutes
16263295|NCT00912574|Drug|GM-CSF-in-adjuvant|"For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
~In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
~1 ml saline
~specified dose of GM-CSF in 1 ml saline
~an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
~an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant"
16263296|NCT00912574|Drug|Montanide ISA-51|"For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
~In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
~1 ml saline
~specified dose of GM-CSF in 1 ml saline
~an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
~an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant"
16263297|NCT00912574|Biological|GM-CSF and Montanide ISA-51|"For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
~In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
~1 ml saline
~specified dose of GM-CSF in 1 ml saline
~an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
~an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant"
16264638|NCT00902486|Drug|INCB028050|10 mg capsule QD
16263298|NCT00912574|Drug|Saline|"For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
~In stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar at one of two time points:
~1 ml saline
~specified dose of GM-CSF in 1 ml saline
~an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
~an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant"
16263299|NCT00912561|Behavioral|Intense aerobic exercise|3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks
16263300|NCT00912548|Drug|goserelin|"Zoladex™ administration:
~Zoladex™ depot is available as a sterile disposable syringe. The depot is administered subcutaneously under the abdominal skin under sterile conditions. If necessary the injection site may be pre-treated with a local anaesthetic.
~Sequence of administration Zoladex depot:
~The substance is administered for 24 months (2 years) at 28-day intervals (a period of 34 days between 2 administrations must not be exceeded).
~Dosage:
~Each depot contains 3.6mg Zoladex. The substance Zoladex is contained in a while cylindrical rodlet .
~Storage instructions for Zoladex™ Zoladex™ is kept a room temperature."
16263301|NCT00912548|Drug|tamoxifen|"Dose and period of Tamoxifen therapy:
~Tamoxifen is administered in tablet form. Each day 2 X 10 mg or 1 X 20 mg Tamoxifen are taken in the form of the respective tablet.
~Storage instructions for Tamoxifen Tamoxifen is stored at room temperature away from light."
16263302|NCT00912535|Drug|Quetiapine extended release tablet|Quetiapine extended release tablet of 50-300mg/day
16263303|NCT00912535|Drug|Placebo|Placebo orally, as adjunct to the same antidepressant at the same dose.
16263304|NCT00912522|Device|TMS|TRANSCRANIAL MAGNETIC STIMULATION
16263305|NCT00912509|Drug|riboflavin|riboflavin 0.1% is applied every 2 minutes for 30 minutes
16263306|NCT00912509|Device|UVX Light|UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
16263307|NCT00912496|Biological|MF-59|Doses of A/Anhui/05 vaccine (A) will be administered with or without MF59 adjuvant.
16263308|NCT00912496|Biological|A/Anhui/05|Monovalent inactivated surface antigen influenza A/H5N1 (modified Hemagglutinin and Neuraminidase of A/Anhui/01/2005) vaccine supplied in 5mL multi-dose vials with thimerosal [0.01%(w/v)] as a preservative. Each dose level includes both unadjuvanted and MF59C.1 adjuvanted formulations: 7.5, 15, 30, or 60 micrograms (mcg) of H5 Hemagglutinin per milliliter (mL) with MF59C.1, and 7.5, 15, 30, or 60 micrograms (mcg) of H5 Hemagglutinin per milliliter (mL) without MF59C.1 adjuvant.
16263309|NCT00912496|Drug|Placebo|Sterile normal saline for injection (0.9% Sodium Chloride Injection, USP Preservative-Free).
16263310|NCT00912483|Biological|heparin sodium - Blausiegel|Heparin sodium - 5.000UI/0.25mL, twice a day for 7 days and 2 hours before the surgery
16263311|NCT00912483|Biological|Heparin sodium - APP|Heparin sodium - 5.000USP/mL, twice a day for 7 days and 2 hours before the surgery
16263312|NCT00912470|Procedure|ocular blood flow measurement|"Retinal blood flow (with scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer) each measurement once on the study eye
~Choroidal blood flow (with laser Doppler flowmetry, laser interferometry, pneumotonometry)
~Frequency distribution of alleles of genetic markers for NOS3, more precisely eNOS -786CC polymorphism and of ET-1 (EDN1), and the receptors ETA (EDNRA), more precisely EDN1/+138/ex1 del/ins, EDN1/K198N, EDNRA/C+1222T, EDNRA/C+70G polymorphisms"
16263313|NCT00912457|Drug|donepezil|donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
16263314|NCT00912457|Drug|placebo|placebo 1 p/day for 28 days
16263315|NCT00912444|Drug|Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide|Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
16263316|NCT00912444|Drug|Docetaxel, cyclophosphamide|Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles
16263317|NCT00912431|Drug|ABT-126|ABT-126 administered on Day 1 of Period 1
16263318|NCT00912431|Drug|Placebo|Placebo for ABT-126 administered on Day 1 of Period 2
16263319|NCT00912418|Biological|autologous tumor cells plus GM-CSF-in Adjuvant|"Autologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.
~Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods."
16263320|NCT00912405|Device|Steroid-Eluting Sinexus Intranasal Splint|Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
16263321|NCT00912392|Drug|Endostar|Endostar® 7.5mg/m2 on day 1 to day 14
16263322|NCT00912392|Drug|Etoposide-Carboplatin|Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
16263323|NCT00912379|Biological|hemoglobin determination|laboratory and non invasive hemoglobin determinations
16263324|NCT00912366|Procedure|Lobectomy|Assessment of VATS versus open surgery.
16263325|NCT00912353|Drug|AZD7268|Single Oral
16263326|NCT00912353|Drug|Placebo|Single Oral
16263327|NCT00912340|Drug|Everolimus|
16263328|NCT00912340|Biological|Trastuzumab|
16263329|NCT00912327|Biological|Imprime PGG|Imprime PGG, 4 mg/kg, i.v. over 2 hr, weekly in 6 week cycles and Cetuximab, initial dose will be 400 mg/m2 via i.v., and subsequent doses will be 250 mg/m2 via i.v., weekly in 6 week cycles
16263330|NCT00912314|Procedure|PTNS|Monthly PTNS after 12 weeks of weekly PTNS
16263331|NCT00912301|Drug|Sodium chenodeoxycholate (NaCDC)|500 or 1000 milligrams NaCDC per day each for a period of 4 days
16263332|NCT00912301|Other|Placebo|Placebo capsules with identical appearance to the study drug were prepared by the Mayo Clinic research pharmacy.
16263333|NCT00912288|Drug|Dimebon 20 mg po TID|Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
16263334|NCT00912288|Drug|Placebo po TID|Placebo (matched to Dimebon) po for 26 weeks
16263381|NCT00911911|Procedure|Blood sampling|Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy
16263335|NCT00912275|Drug|lapatinib plus oral vinorelbine|Lapatinib -dose level -I, I, II, III 1000mg po daily;dose level IV:1250mg po daily; Oral vinorelbine at the dose level reached on days 1, and 8 of a 21 days cycle. Dose level -I:30mg/m2,I:40mg/m2,II:50mg/m2,III:60mg/m2,IV:60mg/m2,V:80mg/m2
16263336|NCT00912262|Drug|Capsaicin Topical Liquid|
16263337|NCT00912249|Behavioral|Horticulture Therapy|We will design courses of Horticultural therapy to provide to the Patients in Day Care Unit
16263338|NCT00912223|Biological|Hematopoietic Stem Cell Transplant|"NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.
~The conditioning regimen will consist of the following:
~Rituxan 375 mg/m^2 on Day -13
~Rituxan 1000 mg/m^2 on Days -6, +1, and +8
~Fludarabine 30 mg/m^2 on Days -5 to -3
~Cyclophosphamide 750 mg/m^2 on Days -5, -4, -3
~Day 0 will be the day of the transplant.
~The GVHD prophylaxis will consist of the following:
~Tacrolimus .09 mg/kg/po (Day -2 thru Day +180). Doses will be adjusted to maintain blood levels of 5-15 ng/mL.
~Methotrexate 5 mg/m^2 (Days +1, +3, and +6). Unrelated donor recipients will receive a fourth dose on Day +11."
16263339|NCT00912210|Dietary Supplement|Whey protein isolate|Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage)
16263340|NCT00912210|Dietary Supplement|Maltodextrin powder supplement|Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage)
16263341|NCT00912197|Dietary Supplement|Oligofructose|Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
16263342|NCT00912197|Dietary Supplement|Placebo|Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in
16263343|NCT00912184|Device|Standard polyamide high flux membrane|Standard haemofiltration; CVVH; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hr, anticoagulation as clinically indicated, bicarbonate buffered replacement fluid
16263344|NCT00912184|Device|High cut-off (super high flux) polyamide membrane|CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid
16263345|NCT00912171|Drug|budesonide (Aircort 50 nasal spray)|50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months
16263346|NCT00912171|Drug|montelukast (Singulair)|Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older
16263347|NCT00912158|Other|standard therapy (ST)|standard medical therapy
16263348|NCT00912158|Device|CPAP|Non-invasive mechanical ventilation (CPAP)
16263349|NCT00912158|Device|BIPAP|Non-invasive mechanical ventilation (BIPAP)
16263350|NCT00912145|Drug|Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)|
16263351|NCT00912119|Drug|Epsilon-Aminocaproic Acid|Group C (high dose) will receive a loading dose of EACA of 100 mg/kg over ten minutes followed by a continuous EACA infusion at 40 mg/kg/hr, which will be continued until the end of surgery.
16263352|NCT00912119|Drug|Epsilon-Aminocaproic Acid|Group A (low dose) will receive a loading dose of EACA of 25 mg/kg over ten minutes followed by a continuous EACA infusion at 10 mg/kg/hr, which will be continued until the end of surgery
16263353|NCT00912119|Drug|Epsilon-Aminocaproic Acid|Group B (intermediate dose) will receive a loading dose of EACA of 50 mg/kg over ten minutes followed by a continuous EACA infusion at 20 mg/kg/hr, which will be continued until the end of surgery
16263354|NCT00912119|Drug|Epsilon-Aminocaproic Acid|Group D (extra low dose) will receive a loading dose of EACA of 12.5 mg/kg over ten minutes followed by a continuous EACA infusion at 5 mg/kg/hr, which will be continued until the end of surgery
16263355|NCT00912106|Other|Synovial fluid composition and lubrication analysis|Before HA injection, synovial fluid must be drawn to increase treatment effectiveness. The drawn synovial fluid was then analyzed in the lab. There was no influence for patients enrolled because the drawn synovial fluid would usually be discarded.
16263356|NCT00912093|Drug|Icatibant|Single subcutaneous injection of icatibant, 30 mg
16263357|NCT00912093|Drug|Placebo|Single subcutaneous injection of matching placebo
16263358|NCT00912080|Genetic|genomic signature|genomic signature analysis
16263359|NCT00912054|Drug|DuoTrav APS|travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
16263360|NCT00912054|Drug|Xalacom|XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution
16263361|NCT00912041|Device|Placement of the BrainGate2 sensor(s) into the motor-related cortex|Up to four 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
16263362|NCT00912028|Device|senofilcon A|contact lens
16263363|NCT00912028|Device|lotrafilcon B|contact lens
16263364|NCT00912028|Device|balafilcon A|contact lens
16263365|NCT00912028|Device|methafilcon A|contact lens
16263366|NCT00912028|Device|vifilcon A|contact lens
16263367|NCT00912015|Drug|Tramadol OAD|
16263368|NCT00912015|Drug|Tramadol OAD|
16263369|NCT00912015|Drug|Tramadol OAD|
16263370|NCT00912015|Drug|Tramadol OAD 100mg|
16263371|NCT00912002|Drug|MK-0941|A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
16263372|NCT00911989|Device|NOTES toolbox|Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope
16263373|NCT00911976|Device|Xience V coronary stent|The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions
16263374|NCT00911963|Drug|VCH-222 or matching placebo|capsule, oral, 4 doses once daily or twice daily, 3 days
16263375|NCT00911963|Drug|VCH-222 or matching placebo|capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
16263376|NCT00911963|Biological|peginterferon alfa-2a|subcutaneous injection, 180 μg, once weekly, 48 weeks
16263377|NCT00911963|Drug|ribavirin|tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
16263378|NCT00911937|Drug|Fesoterodine|Fesoterodine 4mg and 8 mg tablets taken daily.
16263379|NCT00911937|Drug|Placebo|Placebo sham 4mg and 8 mg tables taken daily.
16263380|NCT00911924|Device|iStent|Glaukos iStent, medication
16264639|NCT00902486|Drug|Placebo|Placebo matching INCB028050 QD
16263382|NCT00911911|Procedure|BIOPSY|Biopsy at the moment of inclusion, before neoadjuvant chemotherapy
16263383|NCT00911911|Procedure|SURGERY|Surgery after neoadjuvant chemotherapy
16263384|NCT00911898|Drug|MM-111|For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
16263385|NCT00911885|Behavioral|Dietary Intervention|The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians.
16263386|NCT00911872|Device|collagen (EVOLENCE)|injectable collagen
16263387|NCT00911859|Drug|Siltuximab11 mg/kg|Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1.
16263388|NCT00911859|Drug|Siltuximab 8.3 mg/kg or 11 mg/kg|Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period.
16263389|NCT00911859|Drug|Velcade (bortezomib)|Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1.
16263390|NCT00911859|Drug|Velcade (bortezomib)|Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period)
16263391|NCT00911859|Drug|Melphalan|Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.
16263392|NCT00911859|Drug|Melphalan|Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A.
16263393|NCT00911859|Drug|Prednisone|Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.
16263394|NCT00911859|Drug|Prednisone|Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A.
16263395|NCT00911859|Drug|Velcade (bortezomib)|Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert.
16263396|NCT00911859|Drug|Melphalan|Participants will take melphalan 9 mg/m2 orally according to currently approved package insert.
16263397|NCT00911859|Drug|Prednisone|Participants will take prednisone 60 mg/m2 orally according to the package insert.
16263398|NCT00911846|Other|interview|interview using questionnaires
16263399|NCT00911820|Drug|Bevacizumab|
16263400|NCT00911820|Drug|Cisplatin|
16263401|NCT00911820|Drug|Irinotecan|
16263402|NCT00911820|Device|Docetaxel|
16263403|NCT00911807|Drug|Cerebrolysin + donepezil|"Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.
~Donepezil was given PO once daily during the whole study duration (28 weeks). After four weeks the daily dosage was increased from 5 mg to 10 mg."
16263404|NCT00911807|Drug|Cerebrolysin + placebo|"Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.
~Placebo for donepezil was given PO once daily during the whole study duration (28 weeks)."
16263405|NCT00911807|Drug|Donepezil + placebo|"Placebo for Cerebrolysin was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.
~Donepezil was given PO once daily during the whole study duration (28 weeks). After four weeks the daily dosage was increased from 5 mg to 10 mg."
16263406|NCT00911794|Other|Disclosure Writing (Written Disclosure Therapy)|Patients write about a stressful life experience
16263407|NCT00911794|Other|Neutral (Sham) Writing|Patients write about neutral subjects
16263408|NCT00911781|Other|No intervention|We are only asking for photographs from parents.
16263409|NCT00911768|Dietary Supplement|Korean Red Ginseng Powder Capsule|Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study
16263410|NCT00911768|Dietary Supplement|Corn-starch powder with ginseng flavor|"There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.
~The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).
~Main contents: corn-starch with Panax ginseng flavor"
16263411|NCT00911755|Procedure|Endotracheal Intubation|This study is comparing 2 currently accepted methods of endotracheal intubation: laryngoscopy and videolaryngoscopy
16263412|NCT00911755|Procedure|Endotracheal Intubation|
16263413|NCT00911742|Drug|Tramadol Contramid OAD|1 Tramadol Contramid OAD 200 mg tablet as a single dose
16263414|NCT00911742|Drug|Zytram|1 Zytram 200 mg tablet as a single dose
16263415|NCT00911716|Biological|bevacizumab|
16263416|NCT00911716|Drug|cyclophosphamide|
16263417|NCT00911716|Drug|docetaxel|
16263418|NCT00911716|Procedure|adjuvant therapy|
16263419|NCT00911664|Dietary Supplement|Vitamin D|Weekly dose of 5600 IU (800 IU per day)
16263420|NCT00911664|Drug|No supplementation|Control
16263421|NCT00911664|Dietary Supplement|Vitamin D|Weekly dose of 11,200 IU (1600 IU per day)
16263422|NCT00911651|Drug|Salbutamol|400 µg inhalation once
16263423|NCT00911651|Drug|ipratropium bromide|80 µg inhalation once
16263453|NCT00911443|Biological|Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg|Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
16263884|NCT00908232|Drug|Cyclophosphamide|500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles
16263424|NCT00911638|Behavioral|Patient decision aid|"Patients will receive i) Patient education:usual take home education brochure from recruiting hospital ii)a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005.
~iii) a personal decision form:an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process.
~iv) Referred onward to the surgeon with their preferences for surgery using a standardized report of their clinical findings plus decisional data (knowledge, values, preference)."
16263425|NCT00911638|Behavioral|Usual care|"Patients will receive i) the usual take-home educational brochure available at the recruiting hospital describing preparation for surgery after the decision is made, recovery after surgery, and discharge plans.
~ii) Referral onward to surgeon with a standardized report of clinical findings only"
16263426|NCT00911625|Drug|0.5 units/kg daily insulin|Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
16263427|NCT00911625|Drug|0.25 units/kg daily insulin|Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
16263428|NCT00911612|Drug|Colesevelam|Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days
16263429|NCT00911612|Drug|Placebo|Inert capsule matching the study drug, given twice daily
16263430|NCT00911599|Diagnostic Test|Blood metal ion levels|Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.
16263431|NCT00911586|Drug|Testosterone undecanoate|
16263432|NCT00911573|Drug|Tigecycline|50 mg IV every 12 hours up to 14 days
16263433|NCT00911573|Drug|Clindamycin (or Vancomycin if needed)|For clindamycin 10mg/kg (not to exceed 900mg) IV every 8 hours up to 14 days. For vancomycin 15mg/kg (not to exceed 2g/day and adjusted as needed for renal impairment) IV every 8 hours
16263434|NCT00911560|Biological|adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH|Pts receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8, 20, 32, & 52. Minor schedule adjustments are permitted, as needed. Vaccines must occur a minimum of 6 days apart. Induction of antibody response against the target antigens will be assessed. A fixed dose of oral β-glucan (40 mg/kg/day) is started at week 6 or 7(to allow time for generation of antibodies), & continued as approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination. Neutrophils will be tested for glucan effects on cytotoxicity. Antineuroblastoma activity will be monitored using standard radiographic & bone marrow studies, as well as RT-PCR for measurement of minimal residual disease in blood & bone marrow. Phase II treatment schema for patients in 1st CR/VGPR or >2nd CR/VGPR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/m2.
16263435|NCT00911560|Biological|oral β-glucan|Phase II Patients will be randomized to starting oral β-glucan (40 mg/kg/day) in week 1 or in week 6.
16263436|NCT00911547|Drug|montelukast sodium|10 mg tablet taken once daily at bedtime for 16 weeks
16263437|NCT00911547|Drug|beclomethasone|200 ug inhaled, taken twice daily for 16 weeks
16263438|NCT00911547|Drug|Placebo inhaler|placebo inhaler taken twice daily for 16 weeks
16263439|NCT00911547|Drug|placebo tablet|placebo tablet taken once daily at bedtime for 16 weeks
16263440|NCT00911534|Drug|rabeprazole sodium|One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.
16263441|NCT00911534|Drug|Placebo|One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.
16263442|NCT00911521|Drug|human papillomavirus vaccination (Gardasil)|3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
16263443|NCT00911508|Device|Left atrial ablation|"St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
~Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
~Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
~Bard: Stinger
~Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath"
16263444|NCT00911508|Drug|Rate or Rhythm Control Therapy|"Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg
~Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg"
16263445|NCT00911495|Drug|GMI-1070|Intravenous GMI-1070 given as two doses over the course of one day
16263446|NCT00911469|Drug|AS902330|3, 10, 30, 100 or 300 µg intra-articular injection per subject in the Single Ascending Dose (SAD) cohorts and 10, 30, 100, 300 µg or highest tolerated dose intra-articular injection per week for three weeks per subject in the Multiple Ascending Dose (MAD) cohorts.
16263447|NCT00911469|Drug|Placebo|Placebo or, 3, 10, 30, 100 or 300 µg intra-articular injection per subject in SAD cohorts and placebo or, 10, 30, 100, 300 µg or highest tolerated dose of AS902330 intra-articular injection per week for three weeks per subject in MAD cohorts.
16263448|NCT00911456|Procedure|Image-Guided Radiation Therapy using 3D Ultrasound Guided-Therapy|Subjects will have 3 x 3DUS during radiation therapy
16263449|NCT00911456|Procedure|Ultrasound Guided Imaging|"Subjects will undergo a CT scan and an US of your breast for the planning of radiation therapy after a breast conserving operation.
~About 1 week after the start of radiation treatment subjects will have a second CT and US. During this visit subjects will have one CT and three US's. These US's will be performed by 3 different radiation therapists. Part of the current study is to compare the similarity of the 3 US pictures taken by different individuals."
16263450|NCT00911456|Procedure|3 DUS|3 DUS
16263451|NCT00911443|Biological|Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg|Dacarbazine 800 mg/m2 IV on day 1;Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
16263452|NCT00911443|Biological|Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg|Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
16263533|NCT00910884|Procedure|therapeutic dietary intervention|Given orally daily for 12 months
16263454|NCT00911443|Biological|Dacarbazine + Thymosin-alpha-1 3.2 mg|Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
16263455|NCT00911443|Drug|Dacarbazine + Interferon alpha|Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
16263456|NCT00911417|Device|Pathway Jetstream Atherectomy System|The Pathway Jetstream System is a commercially available rotating, aspirating, expandable catheter for active removal of plaque and blood clots in peripheral arteries of the lower limbs.
16263457|NCT00911404|Behavioral|Low CHO|"Diet with 40% total calories from carbohydrates. In the Low-CHO arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat."
16263458|NCT00911404|Dietary Supplement|High CHO diet|Diet with 55% total calories from carbohydrates.
16263459|NCT00911391|Device|Oesophageal Doppler|Non-invasive measurement of doppler-derived cardiovascular variables (CO, aortic flow rate). Used safely over 800, 000 times
16263460|NCT00911391|Procedure|Intraoperative fluid restriction|Current best practice of avoiding fluid overload by intraoperative fluid restriction
16263461|NCT00911378|Procedure|Pressure support ventilation|These patients are weaned by gradual reduction of pressure support and extubated when they tolerate a pressure support of 7 cm of water for one hour.
16263462|NCT00911378|Procedure|Spontaneous breathing trials|These patients are weaned by giving a T piece trial with 8 cm of water pressure support and extubated when they tolerate it for one hour.
16263463|NCT00911365|Biological|autologous mesenchymal stem cells|"4*107 stem cell (100ml) Intra arterial infusion/ one time, then 4*107 stem cell(100ml)Intravenous infusion 3 times/monthly
~-> Total four times"
16263464|NCT00911365|Biological|normal saline|saline
16263465|NCT00911352|Device|Frozen gel glove (Elasto-Gel Mitten)|Gel glove is frozen for > 3 hours at -5 to -30°C prior to use. Each patient wears a triple glove set (surgical glove overlaid with cotton glove, overlaid with gel glove) on their intervention hand. Gloves are worn for duration of infusion (15 mins pre, 60 minutes intratreatment and 15 mins post) to ensure the patients' peripheries are vasoconstricted on commencement of the infusion and for enough time afterwards to ensure circulating drug does not reach the target area. Because of the duration of the infusion, more than one gel glove will be used successively (for 45 minutes each) to maintain a consistently low temperature on the hand and nails.
16263466|NCT00911339|Drug|Atorvastatin|Atorvastatin 10 mg associated with stent genous
16263467|NCT00911339|Drug|Atorvastatin|Atorvastatin 80 mg associated with stent genous
16263468|NCT00911326|Drug|Lymphoseek|Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m
16263469|NCT00911313|Drug|Letrozole tablets (Femara; Novartis Pharma, Switzerland)|2.5 mg letrozole daily from day 3 of the menses for 5 days
16263470|NCT00911313|Drug|metformin HCl (Cidophage®; CID,Cairo, Egypt)|metformin HCl 1500 daily for 6-8 weeks
16263471|NCT00911313|Drug|CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)|150 mg CC for 5 days starting from day 3 of menstruation
16263472|NCT00911300|Drug|fondaparinux|Comparison of different drugs
16263473|NCT00911300|Drug|unfractionated heparin|Comparison of different drugs
16263474|NCT00911300|Drug|Vitamin-K-Antagonist|Comparison of different drugs
16263475|NCT00911287|Drug|Oxymorphone extended release|Study Medication: Oxymorphone ER 5 mg, 10 mg, and 20 mg tablets. Rescue Medication: Oxymorphone IR 5 mg tablets. Treatment will consist of up to 6 months of dosing with oxymorphone ER.
16263476|NCT00911274|Drug|Mycophenolate Mofetil|250 mg Capsule
16263477|NCT00911274|Drug|CellCept®|250 mg Capsule
16263478|NCT00911261|Drug|Oxymorphone Extended Release|"Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets
~Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets
~Treatment will consist of up to 12 months of dosing with Oxymorphone ER."
16263479|NCT00911248|Drug|PTC299|PTC299 will be administered orally at 100 mg/dose twice per day for up to 1 year or until tumor progression
16263480|NCT00911235|Drug|Fesoterodine|Single 8 mg oral dose of fesoterodine
16263481|NCT00911235|Drug|fesoterodine plus fluconazole|On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)
16263482|NCT00911222|Other|non-interventional|non-interventional
16263483|NCT00911209|Behavioral|Dietitian counselling|Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes
16263484|NCT00911196|Other|Retrospective analysis of already archived samples|Analysis using RNA extracted from tissue samples already archived; Analysis by Fluorescent in situ hybridization (FISH) using tissue samples already archived.
16263485|NCT00911183|Biological|filgrastim|Given subcutaneously
16263486|NCT00911183|Biological|pegfilgrastim|Given subcutaneously
16263487|NCT00911183|Biological|rituximab|Given IV
16263488|NCT00911183|Drug|cyclophosphamide|Given IV
16263489|NCT00911183|Drug|liposome-encapsulated doxorubicin citrate|Given IV
16263490|NCT00911183|Drug|prednisone|Given orally
16263491|NCT00911183|Drug|vincristine sulfate|Given IV
16263492|NCT00911170|Drug|Pegfilgrastim|Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.
16263493|NCT00911170|Drug|Placebo|Administered as a single subcutaneous injection using a pre-filled syringe.
16263494|NCT00911170|Biological|Bevacizumab|5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.
16263495|NCT00911170|Drug|Standard Chemotherapy|"Each participant received one of the following chemotherapy regimens at the discretion of treating physician:
~FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil."
16263496|NCT00911157|Drug|Fondaparinux sodium|The dose of Fondaparinux will be determined based on a subject's body weight (< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
16263497|NCT00911157|Drug|unfractionated heparin (UFH)|UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.
16263498|NCT00911144|Biological|GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)|Intramuscular injection, administered as a single dose
16263499|NCT00911144|Biological|Wyeth-Lederle's Prevenar™|Intramuscular injection, administered as a single dose
16263500|NCT00911144|Biological|GSK Biologicals' Hiberix™|Intramuscular injection, administered as a single dose
16263501|NCT00911131|Device|Capsule endoscopy (PillCam ESO)|The capsule endoscope is placed in the mouth and the patient is asked to swallow it with 100cc of water with simethicone in the supine position. Recording is done for 2 minute in this position and then the head is elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient sips 10cc of water and after 15 seconds, they sit upright and sip water again. They can then walk and resume normal activity for 15 minutes.
16263502|NCT00911131|Procedure|EGD|Patients will undergo conventional EGD under conscious sedation for routine screening of esophageal varices.
16263503|NCT00911131|Device|Capsule endoscopy (PillCam ESO) with abdominal binder|An abdominal binder with and inflatable girdle is wrapped around the stomach prior to swallowing the capsule endoscope. The girdle is inflated to 10mmHg for 10 minutes. The capsule is swallowed by the patient and the routine method for the procedure is performed.
16263504|NCT00911118|Radiation|Hypofractionated, image-guided, intensity-modulated external beam radiation|A standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if < 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier.
16263505|NCT00911092|Procedure|Blood sampling|Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy
16263506|NCT00911092|Radiation|Radiation|Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks
16263507|NCT00911092|Drug|Chemotherapy (Fluorouracil and Cisplatin)|"At weeks 1, 5, 8 and 11
~Day 1 to day 4: Fluorouracil 1 gr/m²/day
~Day 1 or 2: Cisplatin 75 mg/m²"
16263508|NCT00911079|Procedure|Hyperthermia|Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)
16263509|NCT00911079|Radiation|HDR brachytherapy|Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants
16263510|NCT00911066|Drug|MLN4924|"MLN4924 intravenous (IV) on a 21-day cycle on one of the following schedules:
~Days 1, 3, and 5, followed by a rest period of 16 days (Schedule A)
~Days 1, 4, 8, and 11, followed by a rest period of 10 days (Schedule B)
~Continuous weekly dosing on Days 1, 8, and 15 (Schedule C)
~Days 1, 4, 11, 15 for Cycle 1 only; Days 1, 4, 8, 11 for all subsequent cycles (Schedule D)
~Dosing on Days 1, 3, and 5 in patients with high-grade MDS or AML (Schedule E)"
16263511|NCT00911066|Drug|Azacitidine|Azacitidine will be administered (IV or subcutaneous (SC)) on Days 8 to 12 and Days 15 and 16 in Cycle 1, and on Days 1 to 5 and Days 8 to 9 (Schedule D)
16263512|NCT00911053|Drug|Melatonin|Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
16263513|NCT00911053|Behavioral|Regular Sleep Schedule|Subjects will maintain a regular sleep schedule of their choosing.
16263514|NCT00911053|Behavioral|Light|Subjects will be exposed to light.
16263515|NCT00911027|Drug|Contrast-enhanced ultrasound guided biopsy|"One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part
~One to four bolus (each 2.4mL) of SonoVue per patient in the main part"
16263516|NCT00911027|Procedure|ultrasound guided systematic biopsy|Current practice of ultrasound guided systematic biopsy
16263517|NCT00911014|Other|Questionnaire|From September 2005 to January 2006, 58 women who underwent surgery for vesicovaginal fistula at the National Hospital Fistula Center in Niamey, Niger were interviewed post-operatively using a questionnaire developed to investigate demographic, social, economic, and cultural factors that may affect formation of fistula. Also included in this questionnaire was evaluation of access to health care as well as patient understanding of counseling regarding their surgery and post-operative instructions, in particular information about future fertility and fistula development.
16263518|NCT00911001|Behavioral|No Drug|Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.
16263519|NCT00910988|Drug|Olanzapine|olanzapine/Zyprexa
16263520|NCT00910988|Drug|Ziprasidone|ziprasidone/Geodon
16263521|NCT00910975|Drug|Peg-interferon-alfa2a (Pegasys)|Peg-interferon-alfa2a 180 µg per week
16263522|NCT00910975|Drug|Ribavirin (Copegus)|Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
16263523|NCT00910962|Drug|GW856553|7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
16263524|NCT00910962|Drug|GW856553|15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
16263525|NCT00910962|Drug|Placebo|Placebo
16263526|NCT00910936|Behavioral|Exercise|12 weeks endurance training, 3 times weekly for 35 minutes
16263527|NCT00910923|Drug|JNJ-38431055|
16263528|NCT00910910|Drug|Lenalidomide|"For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.
~For patients with moderate renal impairment (defined as CrCl ≥ 30 to < 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first."
16263529|NCT00910910|Drug|Chlorambucil|Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
16263530|NCT00910897|Drug|Velcade-Dexamethasone|
16263531|NCT00910897|Drug|Velcade-Thalidomide-Dexamethasone|
16263532|NCT00910884|Other|laboratory biomarker analysis|No supplements are given
16263534|NCT00910871|Drug|TMC207|TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks.
16263535|NCT00910871|Drug|Background Regimen (BR) for MDR-TB|Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks.
16263536|NCT00910858|Drug|Lenalidomide|Lenalidomide 5-mg capsules for oral administration
16263537|NCT00910858|Drug|Recombinant human erythropoietin|Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.
16263538|NCT00910845|Biological|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
16263539|NCT00910845|Drug|normal saline|Normal saline (placebo) injected into the detrusor at Day 1.
16263540|NCT00910832|Drug|Eductyl suppository|one suppository every morning during 21 days
16263541|NCT00910832|Drug|Placebo suppository|placebo suppository every morning during 21 days
16263542|NCT00910806|Drug|TMC207; nevirapine|
16263543|NCT00910793|Drug|Inuvair|6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol
16263544|NCT00910780|Drug|Aripiprazole|via oral tablets, everyday
16263545|NCT00910780|Drug|Zyprexa|via oral tablets, taken once daily
16263546|NCT00910780|Drug|Risperdal|via oral tablets, taken once daily
16263547|NCT00910767|Device|Conventional insulin pump delivery|Subcutaneous delivery of Novorapid insulin according to usual pump regime
16263548|NCT00910767|Device|Closed loop|Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
16263549|NCT00910754|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg (4 x 250 mg tablets) administered orally once daily.
16263550|NCT00910754|Drug|Prednisone|Prednisone 5 mg tablets administered orally twice daily.
16263551|NCT00910741|Drug|Nanoplatin (NC-6004) and Gemcitabine|
16263552|NCT00910728|Drug|AZD1480|Oral capsule 2.5 mg, 10 mg and 40 mg
16263553|NCT00910715|Drug|doxycycline|doxycycline 100 mg bid, 10 days
16263554|NCT00910715|Drug|doxycycline|doxycycline 100 mg bid, 15 days
16263555|NCT00910715|Drug|placebo|control subjects without a history of Lyme borreliosis
16263556|NCT00910702|Device|foldable capsular vitreous body(FCVB)|the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV
16263557|NCT00910689|Drug|Propranolol or nadolol|Treatment initiated with 1 capsule (60 mg long acting propranolol hydrochloride) and increased to 3 capsules (180 mg) at week 12 as tolerated. If subject does not tolerate at least 2 capsules (120 mg) of propranolol hydrochloride-LA, and in treating neurologist's judgment are unimproved, subject switched to second medication (nadolol). Participants initially receive a single 40 mg capsule of nadolol and increased to 2 capsules (80 mg) as tolerated. At week 12 dose stabilized at highest tolerated level. In evaluation phase, an increase to 4 capsules of long acting propranolol hydrochloride (240 mg) or 3 capsules of nadolol (120 mg) permitted.
16263558|NCT00910689|Drug|Placebo control|Placebo
16263559|NCT00910689|Behavioral|Behavioral Migraine Management (BMM)|"Session 1: Overview of the pathophysiology of migraine; introduce muscle stretching, deep breathing, PMR, imagery; Session 2: Development trigger management strategy; Use early warning signs as a cue to use behavioral migraine management and acute medication; Session 3:(a) continue with basic migraine management skills if these skills have not been mastered;(b) introduce cognitive-behavioral stress-management, if stress is a salient migraine trigger;(c) introduce thermal biofeedback (hand warming) training with a portable home thermal biofeedback device, if stress is not a notable migraine trigger. Session 4: Review problems using various behavioral migraine management skills; Prepare written migraine management plan; Relapse prevention addressed"
16263560|NCT00910689|Drug|Optimal Acute Therapy|This acute therapy protocol emphasized treatment with a 5-HT1B/D-agonist or triptan. Nonsteroidal anti-inflammatory (NSAID; ibuprofen) and anti-emetic (metoclopramide) medication could be added as needed. The choice of triptans (rizatriptan®, sumatriptan®), the route(s) of triptan administration (oral, nasal spray, subcutaneous injection), and the addition of a NSAID, or anti-emetic were tailored to participant preference, treatment history and acute therapy response. Individualized handouts and a phone call (week 3) of the OAT Run-in were used to help participants evaluate and optimize their acute therapy.
16263561|NCT00910676|Drug|Diprosone|"Start of treatment: as soon as the EGF-R inhibitors treatment begins
~Application: On the body area susceptible to be affected by folliculitis, once a day, in the evening
~Dosage: Quantity corresponded to around 2 tubes of 30 grams a week on the face, the chest and upper side of the back. There is no maximum dosage.
~Period of treatment: 8 weeks"
16263562|NCT00910663|Drug|Mycophenolate Mofetil|250 mg Capsule
16263563|NCT00910663|Drug|CellCept®|250 mg Capsule
16263564|NCT00910650|Biological|F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells|After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
16263565|NCT00910650|Drug|non-myeloablative conditioning chemotherapy|Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
16263566|NCT00910637|Drug|Gestodene/EE Patch (BAY86-5016)|55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles
16263567|NCT00910624|Drug|Boceprevir|Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO)
16263568|NCT00910624|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
16263569|NCT00910624|Drug|Ribavirin (SCH 18908)|Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
16263570|NCT00910598|Drug|glatiramer acetate|20 mg daily s.c. for 1 year
16263571|NCT00910585|Behavioral|Coaching, providing social support|Active telephone and in person coaching
16263615|NCT00910182|Procedure|splenorrhaphy|surgical treatment of splenic injuries after blunt abdominal trauma.
16263616|NCT00910169|Other|inpatient treatment|Hospitalisation modalities are described but are naturalistic
16263617|NCT00910156|Device|Airtraq laryngoscope|Airtraq intubation
16263618|NCT00910156|Device|Glidescope laryngoscope|glidescope intubation
16263572|NCT00910572|Device|Yttrium-90 microspheres (Therasphere MDS Nordion)|Y-90 is incorporated into very tiny glass beads (microspheres: Therasphere MDS Nordion) and is injected into the liver tumor through the hepatic arteries, which are responsible for the feeding of the neoplastic liver tissue. Since the microspheres are unable to pass through the micro-vasculature of the liver parenchyma and tumor they are trapped at those sites and exert a local radio-therapeutic effect.
16263573|NCT00910546|Device|visicoil gold marker 0.7 x 20 mm|CT - guided implantation into lung tumors
16263574|NCT00910533|Drug|ceftriaxone|ceftriaxone 2 g od i.v. for 14 days
16263575|NCT00910520|Biological|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
16263576|NCT00910520|Drug|normal saline|Normal saline (placebo) injected into the detrusor at Day 1.
16263577|NCT00910507|Behavioral|Exercise counseling|Each participant in the experimental group receives 2 months of exercise counseling from the same physical therapist as described in previous research. In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program. Exercise counseling is tailored to the stage of exercise behavior as described in previous literature. The experimental group is also provided access to a fitness center.
16263578|NCT00910507|Behavioral|Supervised exercise training|Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program. Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
16263579|NCT00910494|Radiation|Photon Radiosurgery System IORT|
16263580|NCT00910494|Radiation|Photon Radiosurgery System IORT|
16263581|NCT00910481|Device|Intra-Aortic Balloon Pump|Elective IABP insertion before PCI
16263582|NCT00910468|Procedure|Robot-assisted Laparoscopic myomectomy|Robot-assisted Laparoscopic myomectomy
16263583|NCT00910455|Drug|SRX246|single oral dose of SRX246 capsule
16263584|NCT00910455|Drug|Placebo|Single oral dose of placebo capsule
16263585|NCT00910442|Dietary Supplement|Glutathione precursors|HIV+ patients were assigned to 7 day diets containing either NAC or Gln
16263586|NCT00910429|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
16263587|NCT00910416|Drug|propofol, remifentanil, atracurium|propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment
16263588|NCT00910416|Drug|propofol, remifentanil, atracurium, sevoflurane|dosages are adapted according to clinician's judgment
16263589|NCT00910416|Device|EEG monitoring|simultaneous monitoring with Bis and Neurosense
16263590|NCT00910403|Procedure|LASIK|Excimer Laser Ablation using LASIK
16263591|NCT00910390|Other|Slow freezing|Embryos at different developmental stages will be frozen using a solution that contains propanediol and sucrose, individually placed in high security straws, cooled with a programmator and stored in liquid nitrogen.
16263592|NCT00910390|Other|VIT-Irvine|Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.
16263593|NCT00910390|Other|Vit-Vitrolife|Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.
16263594|NCT00910377|Behavioral|counseling sessions|The intervention groups received counseling sessions about breastfeeding and complementary feeding at maternity ward and at home with 7,15,30,60 and 120 days.
16263595|NCT00910364|Other|Exercise|Exercise
16263596|NCT00910351|Drug|Ciprofloxacin (Cipro, BAYQ3939)|25 mg inhaled Ciprofloxacin
16263597|NCT00910338|Device|PFMT with Extracorporeal Biofeedback|"Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks
~Twice a week for the first 4 weeks
~Once a week for the next 8 weeks"
16263598|NCT00910325|Procedure|Laparoscopic-assisted transvaginal cholecystectomy|Trans-vaginal Cholecystectomy with Laparoscopic Assistance
16263599|NCT00910312|Device|Ice-Sense|Ice-Sense Cryoprobe
16263600|NCT00910299|Drug|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
16263601|NCT00910299|Drug|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
16263602|NCT00910286|Other|Pulmonary Ventilator|The aim of the present study was to compare two different cycling off modes in PSV, a fixed and other automatic, about ventilatory mechanic variables, breathing comfort and patient-ventilator asynchrony patterns
16263603|NCT00910273|Drug|etanercept|etanercept 50 mg/week
16263604|NCT00910260|Procedure|Blood analysis|Serum 25-hydroxyvitamin D, calcium, parathormone, phosphate, C-reactive protein and albumin levels will be measured at every visit: day 0, day 7 and day 84.
16263605|NCT00910247|Drug|Eslicarbazepine acetate|800 to 2400 mg once daily (QD)
16263606|NCT00910234|Drug|recombinant human erythropoietin (rhEpo)|rhEpo is administered 3000 U/kg, iv at 3 to 6 hours after birth, and at 24 hours interval for another 2 doses.
16263607|NCT00910234|Drug|recombinant human erythropoietin (rhEpo)|rhEpo is administered 100 U/kg, iv at 3 to 6 hours after birth, and at 24 hours interval for another 2 doses.
16263608|NCT00910234|Drug|Normal saline|normal saline is administered 0.5/kg, iv at 3 to 6 hours after birth, and at 24 hours interval for another 2 doses.
16263609|NCT00910221|Drug|Atorvastatin|Atorvastatin tablet
16263610|NCT00910221|Drug|Placebo|Placebo tablet
16263611|NCT00910208|Device|Patient-controlled analgesia|Intravenous morphine delivered via Curlin painsmart PCA device
16263612|NCT00910208|Drug|morphine|Intravenous morphine
16263613|NCT00910195|Device|CPAP treatment with subsequent Bi-Level-APAP treatment|CPAP treatment during the first night and then Bi-level-APAP treatment during second night
16263614|NCT00910195|Device|Bi-Level-APAP treatment with subsequent CPAP treatment|Bi-level-APAP treatment during the first night and then CPAP treatment during the second night
16263620|NCT00910143|Procedure|conventional rectal surgery|type of rectal surgery before the introduction of TME
16263621|NCT00910143|Procedure|total mesorectal excision|total mesorectal excision
16263622|NCT00910117|Drug|nimotuzumab|nimotuzumab 400 mg d1
16263623|NCT00910117|Drug|PF regimen (cisplatin and 5-FU)|cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
16263624|NCT00910104|Drug|Omegaven®|10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated
16263625|NCT00910091|Drug|BN83495|BN83495 will be administered as a 40 mg tablet once a day orally
16263626|NCT00910091|Drug|Megestrol Acetate (MA)|MA will be administered orally as 160mg daily
16263627|NCT00910065|Drug|D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV|Single IV dose of aspirin at a dose of 500 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
16263628|NCT00910065|Drug|D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV|Single IV dose of aspirin at a dose of 250 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
16263629|NCT00910065|Drug|Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet|Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
16263630|NCT00910052|Device|Tisseelä fibrin sealant|Fibrin sealant applied intraoperatively
16263631|NCT00910039|Drug|sunitinib malate|Treatment will be administered on an outpatient basis. Patients will receive sunitinib 37.5mg once daily in the morning without regard to meals in repeated 6-week cycles comprising daily therapy for 4 weeks followed by a 2-week rest period. Patients who tolerate this dose may increase the dose to 50 mg once daily.
16263632|NCT00910039|Other|cognitive assessment|The memory test has six alternate forms. The other tests measure motor and information processing speed and are relatively resistant to the effects of practice. The total time for test administration, including the QOL and symptom measures, is 40 minutes.The difference between the pre-treatment baseline and follow-up assessment scores will be determined by the reliable change (RC) index. This index is derived from the standard error of measurement (SEM) for each test in the battery: 1 (deterioration), 2 (no change), or and 3 (improved).
16263633|NCT00910026|Procedure|low tidal volume ventilation|6 ml/kg tidal volume ventilation
16263634|NCT00910026|Procedure|high tidal volume ventilation|12 ml/kg tidal volume ventilation
16263635|NCT00910013|Drug|Ropivacaine|0.5% intra-articular ropivacaïne (20cc)
16263636|NCT00910000|Drug|Vorinostat|
16263637|NCT00910000|Drug|Carboplatin|
16263638|NCT00910000|Drug|Gemcitabine|
16263639|NCT00909987|Drug|Capecitabine|PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
16263640|NCT00909987|Drug|Oxaliplatin|IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
16263641|NCT00909987|Drug|Bevacizumab|IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
16263642|NCT00909987|Radiation|Radiotherapy|Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
16263643|NCT00909987|Drug|Capecitabine during all Radiotherapy period|825 mg/m2 bid
16263644|NCT00909987|Procedure|Total Mesorectal Excision (TME)|4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after
16263645|NCT00909974|Dietary Supplement|UNIMMAP - multiple micronutrients|"Daily supplementation of one UNIMMAP tablet
~multiple micronutrient supplements (MMN): UNIMMAP: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg"
16263646|NCT00909974|Dietary Supplement|Food supplement enriched with multiple micronutrients|"One dose of 72g per day during whole pregnancy
~Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg"
16263647|NCT00909961|Drug|Zoledronic acid|
16263648|NCT00909948|Other|Fludarabine and total body irradiation|The patients in the second cohort will receive fludarabine 30 mg/m2/day on days -4 to -2 and 200 cGy TBI on day 0.
16263649|NCT00909948|Radiation|Total body irradiation|Patients will receive 200 cGy TBI on day 0,4-6 hours prior to HCT.
16263650|NCT00909935|Drug|Dexmedetomidine|Initial 2 mcg/kg bolus administered over 10 minutes to achieve the Ramsey sedation score of 4 followed by an infusion of 1.5 mcg/kg/hr, which will run until patient is transferred to recovery area. Up to a further two boluses of 2 mcg/kg may be given to maintain an RSS of 4.
16263651|NCT00909909|Radiation|External beam boost|3-dimensional conformal radiation therapy and intensity modulated radiation therapy
16263652|NCT00909909|Radiation|whole breast irradiation|accelerated, hypofractionated whole breast irradiation
16263653|NCT00909883|Drug|Botulinum Toxin: Xeomin|45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
16263654|NCT00909883|Drug|Placebo|Placebo injection
16263655|NCT00909870|Device|Dermagraft(R)|Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
16263656|NCT00909870|Device|Profore|Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
16263657|NCT00909857|Drug|Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
16263658|NCT00909857|Drug|Ethinyl estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
16263659|NCT00909857|Drug|Placebo Match to SH T00658ID|Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
16263660|NCT00909857|Drug|Placebo Match to SH D593B|Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
16263661|NCT00909844|Drug|Triptorelin (I.N.N.)|Decapeptyl® SR 11.25mg
16263662|NCT00909831|Drug|hydroxychloroquine|
16263663|NCT00909831|Drug|temsirolimus|
16263664|NCT00909831|Other|electron microscopy|
16264049|NCT00907036|Biological|alemtuzumab|
16263671|NCT00909818|Radiation|standard fractionated radiotherapy|standard fractionated radiotherapy 50 Gy/25 fractions
16263672|NCT00909818|Radiation|hypofractionated radiotherapy|hypofractionated radiotherapy 40 Gy/15 fractions
16263673|NCT00909805|Device|cutaneous suture (Surjet)|cutaneous surjet suture
16263674|NCT00909805|Device|2-octyl-cyanoacrylate (Dermabond® glue)|the cutaneous suture is made with glue only
16263675|NCT00909792|Device|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
16263676|NCT00909792|Device|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
16263677|NCT00909779|Drug|Arformoterol|Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year
16263678|NCT00909779|Drug|Placebo|Placebo inhalation solution, twice daily (BID) for a duration of one year.
16263679|NCT00909766|Drug|BMS-830216|Capsules, Oral, 30 mg, once daily, 28 days
16263680|NCT00909766|Drug|BMS-830216|Capsules, Oral, 100 mg, once daily, 28 days
16263681|NCT00909766|Drug|BMS-830216|Capsules, oral, 300 mg, once daily, 28 days
16263682|NCT00909766|Drug|BMS-830216|Capsules, oral, 600 mg, once daily 28 days
16263683|NCT00909766|Drug|BMS-830216|Capsules, oral, 1200 mg, once daily, 28 days
16263684|NCT00909766|Drug|BMS-830216|Capsules, Oral, to be determined, once daily, 28 days
16263685|NCT00909766|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 28 days
16263686|NCT00909753|Drug|Ursodiol|Ursodiol Tablets, 500 mg
16263687|NCT00909753|Drug|Urso Forte™|Urso Forte™ Tablets, 500 mg
16263688|NCT00909740|Drug|MEGF0444A|Intravenous escalating dose
16263689|NCT00909727|Drug|Ivacaftor|150-mg tablet given orally q12h for up to 48 weeks
16263690|NCT00909727|Drug|Placebo|Tablet given orally q12h for up to 48 weeks
16263691|NCT00909714|Device|DC-Stimulator to apply tDCS|Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
16263692|NCT00909714|Device|DC-Stimulator to apply Sham tDCS|Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
16263693|NCT00909701|Dietary Supplement|PreOP Booster|1 serving of 400 ml per study arm
16263694|NCT00909701|Dietary Supplement|PreOP (Nutricia Clinical Care, Trowbridge, UK)|1 serving of 400 ml per study arm
16263695|NCT00909688|Drug|BLI-489|
16263696|NCT00909688|Drug|placebo|
16263697|NCT00909662|Procedure|assessment of therapy complications|"Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
~Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
~Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
~Borg 15-Category Scale"
16263698|NCT00909662|Procedure|cognitive assessment|Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
16263699|NCT00909662|Procedure|fatigue assessment and management|"Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
~Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
~Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
~Borg 15-Category Scale"
16263700|NCT00909649|Procedure|fibrin glue in breast surgery|fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group
16263701|NCT00909636|Drug|ABT-333|See arm description for more information
16263702|NCT00909636|Drug|Placebo|See arm description for more information
16263703|NCT00909610|Drug|Ursodiol|Ursodiol Tablets, 500 mg
16263704|NCT00909610|Drug|Urso Forte™|Urso Forte™ Tablets, 500 mg
16263705|NCT00909597|Drug|pioglitazone|30mg po once daily for 4 weeks, followed by 45mg once daily
16263706|NCT00909597|Drug|taspoglutide|10mg sc once weekly
16263707|NCT00909597|Drug|taspoglutide|10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
16263708|NCT00909584|Drug|Ezatiostat Hydrochloride|Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)
16263709|NCT00909571|Drug|FK506E (modified release tacrolimus)|oral
16263710|NCT00909571|Drug|Prograf (tacrolimus)|injection
16263711|NCT00909558|Biological|Autologous Natural Killer / Natural Killer T Cell Immunotherapy|"The study drug is derived from ex vivo expansion of each subject's own white blood cells and is therefore autologous.
~The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 2 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 15 weeks."
16263712|NCT00909545|Drug|Isradipine CR 5mg|5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
16263713|NCT00909545|Drug|Isradipine CR 10mg|10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
16263714|NCT00909545|Drug|Isradipine CR 20mg|20mg dose: 4 Dynacirc CR 5mg tablets once daily
16263715|NCT00909545|Drug|Placebo|4 Placebo to Match (PTM) tablets once daily
16263716|NCT00909532|Drug|Ivacaftor|150-mg tablets given orally q12h for up to 48 weeks
16263717|NCT00909532|Drug|Placebo|Tablet given orally q12h for up to 48 weeks
16263718|NCT00909519|Drug|naproxcinod|naproxcinod 750 mg bid
16263719|NCT00909519|Drug|Naproxen|Naproxen 500 mg bid
16263720|NCT00909519|Drug|placebo|placebo
16263721|NCT00909519|Drug|furosemide|furosemide
16263722|NCT00909506|Drug|Placebo|"Control: Receive placebo pill once every evening on 1~2 weeks.
~Receive placebo pill in every morning and evening on 3~24 weeks (twice a day)."
16263723|NCT00909506|Drug|Metformin|"Metformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1~2 weeks.
~Receive placebo pill in every morning and oral metformin 500 mg in every evening on 3~24 weeks."
16263724|NCT00909506|Drug|Metformin|"Metformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1~2 weeks. (Dose-escalate)
~Receive oral metformin 500 mg in every morning and evening on 3~24 weeks (metformin 500 mg * twice a day = 1000 mg per day)."
16263725|NCT00909493|Other|Network Access|Primary Care Physicians in this treatment group will have access to a pain specialist at the Pain Management Unit.
16263726|NCT00909480|Drug|insulin detemir|"Treat-to-target (individually adjusted dose) titration according to titration algorithm.
~S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued"
16264050|NCT00907036|Biological|donor lymphocytes|
16263727|NCT00909480|Drug|insulin glargine|"Treat-to-target (individually adjusted dose) titration according to titration algorithm.
~S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued"
16263728|NCT00909467|Other|echocardiography, right heart catheterisation|at each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension.
16263729|NCT00909454|Dietary Supplement|2000 IU Vitamin D3 daily supplement|2000 IU vitamin D3 supplement to be taken once daily over 4 months
16263730|NCT00909454|Dietary Supplement|400 IU Vitamin D3 supplement|400 IU Vitamin D3 supplement to be taken daily over 4 months
16263731|NCT00909441|Procedure|Sentinel Lymph Node Biopsy|Sentinel node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells.
16263732|NCT00909428|Drug|Solifenacin Succinate|Participants take 10mg daily solifenacin succinate for 30 days
16263733|NCT00909402|Drug|BMS-833923|Capsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
16263734|NCT00909402|Drug|Cisplatin|Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
16263735|NCT00909402|Drug|Capecitabine|Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
16263736|NCT00909389|Drug|Vytorin (R) (Ezetimibe + Simvastatin)|Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days
16263737|NCT00909363|Drug|Promacta|"WAS Patients receiving treatment will start on 1 mg/kg of eltrombopag daily and be seen weekly for 12 weeks. Dose adjustment will be based on the weekly monitoring of the platelet count as utilized in ongoing studies in ITP as well as on liver tests.
~they will also have diagnostic blood testing prior to initiating treatment"
16263738|NCT00909363|Diagnostic Test|blood drawing in patients with WAS|blood will be drawn for platelet parameters in WAS patients not receiving treatment either because they declined or because they were ineligible
16263739|NCT00909363|Diagnostic Test|blood drawing in healthy controls|blood will be drawn once in healthy children as controls for platelet parameters
16263740|NCT00909337|Drug|Bosentan|2x62.5mg for 4 weeks, then 2x125mg
16263741|NCT00909324|Drug|Pre-LASIK 0.3% hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
16263742|NCT00909324|Drug|Post-LASIK 0.3% hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
16263743|NCT00909311|Drug|ABT-450|capsules, QD, 1 dose in each cross-over period
16263744|NCT00909311|Drug|ritonavir|capsule, QD, 1 dose in each cross-over period
16263745|NCT00909298|Drug|TTP889|300 mg
16263746|NCT00909298|Drug|Placebo|Placebo
16263747|NCT00909285|Device|TMS stimulation|TMS stimulation and cognitive training
16263748|NCT00909285|Device|Sham comparator|Sham comparator
16263749|NCT00909285|Behavioral|Cognitive training|TMS stimulation and cognitive training
16263750|NCT00909272|Procedure|Lumbar medial branch block|The ultrasound probe will be placed perpendicular to skin along the midline of lumbar spinous process on longitudinal view first to count the lumbar level. The midpoint of each lumbar level will be marked on the longitudinal view and then will be rotated ninety degrees counter clockwise to axial view to locate the facet joint and the transverse process of lumbar spine. A #22 gauge 10cm long Quincke spinal needle will be inserted to the target area using in plane approach on the axial view. Then the probe will be rotated ninety degrees clockwise to longitudinal view to ensure needle tip is placed on the cephalad aspect of the transverse process. It will then be immediately confirmed by C-arm fluoroscopy on oblique view.
16263751|NCT00909272|Procedure|Ultrasound landmarks|The target point is the superior medial aspect of transverse process of lumbar spine from L3 to S1. A #22 gauge 10cm long Quincke spinal needle will be use for needle placement. Needle placement will be visualized with ultrasound. Practice on cadavers with 3 different operators and see if results are reproducible. Verify with fluoroscopy.
16263752|NCT00909259|Device|Phrenic stimulation device|In Stage 1, a stimulation lead will be introduced via standard access methods and positioned to provide stimulation. A second lead may also be placed for sensing purposes. The proximal portions of the implanted lead(s) will remain externalized such that stimulation and observation can be made using external stimulation and recording equipment. Study subjects will be observed and stimulation will be performed for up to 2 nights of sleep in a clinically supported environment. In Stage 2, a stimulation device and lead will be permanently implanted.
16263753|NCT00909233|Drug|Vardenafil, (Levitra, BAY38-9456)|Patients under daily life treatment receiving Levitra according to local drug information.
16263754|NCT00909220|Behavioral|Behavioral Activation|Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis & Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
16263755|NCT00909207|Behavioral|Interview|Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
16263756|NCT00909194|Behavioral|Psychoeducational Seminar and Relaxation Technique|Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique
16263757|NCT00909181|Drug|Oxybutynin|"Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.
~Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo"
16263758|NCT00909181|Drug|Placebo|"Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.
~Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo"
16263759|NCT00909168|Drug|FLAIMy - Fluda, Ida, Ara-C, Mylotarg|"FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5
~ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5
~IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5
~GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6"
16263760|NCT00909155|Drug|Venlafaxine ERT|Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.
16263761|NCT00909155|Drug|Fluoxetine|Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
16263762|NCT00909142|Drug|Bonefos (Clodronate, BAY94-8393)|Patients in regular clinical practice receiving Bonefos according to local drug information
16263763|NCT00909129|Drug|pegylated interferon-alpha (Pegasys)|Pegylated interferon-alpha 2a 180 micrograms s.c. weekly
16263764|NCT00909129|Drug|ribavirin (COPEGUS)|ribavirin bid 800-1200 mg depending on HCV genotype and body weight
16263765|NCT00909116|Procedure|Stapled Transanal Rectal Resection with Contour Transtar|Transanal Stapling procedure - Stapled Transanal Rectal Resection
16263766|NCT00909090|Dietary Supplement|12 mg Lutein + Zeaxanthin|10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year
16263767|NCT00909090|Dietary Supplement|Visually identical placebo|Visually identical placebo, taken once daily for one year
16263768|NCT00909077|Drug|Dexamethasone|Dexamethasone tablets: 40 mg/day for four days
16263769|NCT00909077|Drug|Dexamethasone and Rituximab|Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)
16263770|NCT00909064|Drug|Fondaparinux Sodium (Arixtra)|2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
16263771|NCT00909051|Drug|Acarbose (Glucobay, BAYG5421)|Patients with diabetes type 2 newly treated with Glucobay
16263772|NCT00909025|Drug|Claudiximab|"Patients receive Claudiximab as intravenous infusion over 2 hours on day 1. Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT.
~After completion of study treatment, patients are followed for 4 weeks."
16263773|NCT00909012|Dietary Supplement|high oleic sunflower oil|placebo, which does not provide DHA
16263774|NCT00909012|Dietary Supplement|microalgal oil|the supplement provides 20 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
16263775|NCT00909012|Dietary Supplement|microalgal oil|the supplement provides 40 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
16263776|NCT00909012|Dietary Supplement|microalgal oil|the supplement provides 80 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
16263777|NCT00909012|Dietary Supplement|microalgal oil|the supplement provides 130 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
16263778|NCT00908986|Drug|Rituximab|375mg/m2 q week x 4; repeated in 6 months
16263779|NCT00908960|Drug|Enoxaparin|
16263780|NCT00908947|Device|PTA followed by placement of LifeStent® Vascular Stent|PTA followed by placement of LifeStent® Vascular Stent
16263781|NCT00908934|Drug|AZD9056 formulation Phase III 50 mg (T)|Given as 50 mg tablet (T)
16263782|NCT00908934|Drug|AZD9056 formulation Phase IIb 50 mg (R)|Given as 50 mg tablet (R)
16263783|NCT00908934|Drug|AZD9056 formulation Phase III 200 mg (T)|Given as 400 mg (2 x 200 mg tablet (T))
16263784|NCT00908934|Drug|AZD9056 formulation Phase IIb 200mg (R)|Given as 400 mg (2 x 200 mg tablet (R))
16263785|NCT00908921|Drug|GLIMEPIRIDE|Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)
16263786|NCT00908908|Drug|eribulin|Cycle 1 day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on days 1 and 8 every 21 days.
16263787|NCT00908895|Procedure|Radio-radial fixator|Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
16263788|NCT00908895|Procedure|Percutaneous pinning|Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.
16263789|NCT00908882|Behavioral|Motivation Interviewing Counseling|Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions
16263790|NCT00908869|Drug|Vinorelbine, Cyclophosphamide and Interferon alpha 2b|"Level 1: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.
~Level 2: Oral Vinorelbine (Navelbine®)20mg x 3/week; oral Cyclophosphamide (Endoxan®) 50mg/day;SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.
~Level 3: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 5/week.
~Level -1 (in case of toxicity at level 1): Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/every 2 days; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week ."
16263791|NCT00908856|Biological|autologous bone marrow mononuclear cell transfusion|a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow
16263792|NCT00908856|Biological|marrow stromal cells|a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)
16263793|NCT00908856|Drug|placebo|a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow
16263794|NCT00908843|Other|Intravenous hydration with bicarbonate|Intravenous hydration with bicarbonate 1/6 M intravenous infusion (3ml/Kg/h) one hour before the administration of intravenous contrast
16263881|NCT00908271|Drug|Dapagliflozin|Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day
16263795|NCT00908843|Other|Oral hydration with Sodium solution|Oral hydration with Sodium solution (Casen solution of rehydration) in the 4 hours before of the intravenous contrast administration (75 ml/10 kg as equivalent to 0,25 g of sodium chloride /10 kg).
16263796|NCT00908817|Drug|triamcinolone acetonide|paste applied over tracheal tube for lubrication
16263797|NCT00908817|Drug|chlorhexidine gluconate|jelly applied over tracheal tube for lubrication
16263798|NCT00908804|Procedure|open appendectomy|
16263799|NCT00908804|Procedure|laparoscopic appendectomy|
16263800|NCT00908791|Drug|Conjugated Linoleic Acid (CLA)|Conjugated linoleic acid (CLA, Clarinol™) oral soft gel capsules will be administered in an open-labeled, manner to all subjects enrolled in the study. Subjects will be treated with 7.5 grams of oral CLA daily, taken in divided dose, twice daily between 8 am and 12 noon and between 8 pm and 12 midnight. CLA will be taken for a minimum of ten days prior to surgical resection of their breast malignancy. In the event that the subject's surgical resection date is delayed, subjects may take CLA for up to 28 days. The last dose of CLA prior to the surgical resection will be taken at 12 midnight or as close as possible to that time and the patient will record the time of the last dosing.
16263801|NCT00908778|Drug|Vitreosolve|intravitreal injection
16263802|NCT00908778|Drug|Vitreosolve|intravitreal injection
16263803|NCT00908765|Behavioral|Exercise|"High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.
~Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks"
16263804|NCT00908752|Drug|Brivanib|Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
16263805|NCT00908752|Other|Brivanib Placebo|Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
16263806|NCT00908752|Procedure|TACE Therapy|Trans-Arterial Chemo-Embolization Therapy
16263807|NCT00908739|Genetic|gene expression analysis|immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
16263808|NCT00908739|Other|immunohistochemistry staining method|immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
16263809|NCT00908739|Other|laboratory biomarker analysis|immunohistochemistry for levels of expression of five different factors related to aggressive tumor behavior (i.e., VEGF expression, E-cadherin regulation, matrix metalloproteinase 2 and 9 activity, and carbonic anhydrase 9 activity)
16263810|NCT00908726|Drug|propofol|Each subject received both propofol formulations in a crossover fashion separated by a 7-day washout period, and the order of the drug administration was randomized. Subjects received both propofol formulations (Lipid emulsion propofol: Diprivan® and Microemulsion propofol: AquafolTM) during 60 min. The infusion rate was assigned according to a nonblinded, randomized design to 1.5, 3, 6, or 12 mg/kg/hr.
16263811|NCT00908713|Drug|methylprednisolone|methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
16263812|NCT00908713|Drug|Placebo|Sodium chloride 0.9% 10 mL every 12 h for 5 days
16263813|NCT00908700|Procedure|Surgical occlusion of the left atrial appendage|Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
16263814|NCT00908700|Procedure|Best medical practice|Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
16263815|NCT00908687|Biological|A/H5N1|A/H5N1 Low Dose
16263816|NCT00908687|Biological|A/H5N1|A/H5N1 High Dose
16263817|NCT00908687|Biological|LT Adjuvant Patch|LT Adjuvant Patch Low Dose
16263818|NCT00908687|Biological|LT Adjuvant Patch|LT Adjuvant Patch High Dose
16263819|NCT00908674|Drug|Cyproterone acetate (Androcur)|"The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment).
~Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate.
~Administration period: 12 months."
16263820|NCT00908661|Device|Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh|Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
16263821|NCT00908648|Procedure|Narrow Band Imaging|Narrow Band Imaging
16263822|NCT00908622|Procedure|Percutaneous autologous myoblast implantation|Endocavity implantation of autologous myoblasts
16263823|NCT00908622|Procedure|Cardiac revascularization|Cardiac revascularization
16263824|NCT00908596|Drug|Gadoxetic acid disodium (Primovist, BAY86-4873)|Primovist/Eovist in approved indications at approved dosages
16263825|NCT00908583|Drug|plasmapheresis|Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.
16263826|NCT00908583|Drug|Bortezomib|Patients will receive bortezomib as described in protocol
16263827|NCT00908583|Drug|Rituximab|Patients will receive rituximab as described in protocol
16263828|NCT00908583|Drug|Methylprednisolone|Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).
16263829|NCT00908570|Drug|estriol|4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.
16263830|NCT00908570|Drug|Placebo|Placebo cream
16263831|NCT00908557|Other|readability improvement and good practice redaction|improvement using Flesch readability index and good practice in redaction of informed consent documents.
16263832|NCT00908557|Other|Control|information based on the classic informed consent document
16263833|NCT00908544|Other|PHI-patients|Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
16263834|NCT00908544|Other|CHI-patients|Treatment intensification of PI-based HAART with Maraviroc and Raltegravir. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
16263835|NCT00908531|Drug|letrozole (Femara)|tablet 2.5 mg daily
16263836|NCT00908505|Procedure|physiotherapy|physiotherapy either by biphasic cuirass ventilator or physiotherapist
16263882|NCT00908245|Procedure|Control|Surgery without preconditioning surgery
16264051|NCT00907036|Drug|cyclosporine|
16263837|NCT00908492|Behavioral|Education Control|Caregiver participants are provided with information about caregiver stress and discuss it individually with an interventionist who visits the home. The control intervention involves 5 visits over 6 months.
16263838|NCT00908492|Behavioral|Environmental Skill Building|The ESP intervention addresses home modifications and training in their use, instruction in strategies of problem-solving, energy conservation, safe task performance, fall recovery techniques, and balance and muscle strength training. Intervention is individualized for target areas identified in the initial client assessment and caregiver interview. The intervention involves using a problem solving approach and client-centred focus and the intervention assessment tools are individualized measures which determine the goals identified by the caregiver. It involves 5 visits over 6 months.
16263839|NCT00908479|Behavioral|Leg Exercise Program|Participants will engage in an extra 45-60 minutes per day of self-managed lower extremity homework exercises focused on improving strength, balance and walking ability.
16263840|NCT00908479|Behavioral|Leg Management group|Therapist provides educational information about leg pain, recovery, bone density, and fall risk.
16263841|NCT00908466|Drug|Sirolimus (rapamycin)|Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.
16263842|NCT00908466|Drug|Sirolimus (rapamycin)|Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.
16263843|NCT00908453|Drug|fosphenytoin|15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
16263844|NCT00908440|Behavioral|Decision Aid|25 page booklet informing patients about PTSD symptoms and treatment options
16263845|NCT00908427|Procedure|photoselective vaporization prostatectomy (PVP)|PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
16263846|NCT00908427|Procedure|Transurethral resection of the prostate|Standard transurethral resection of the prostate using electrocautery loop
16263847|NCT00908414|Drug|TMC589337 40 mg|Participants will receive TMC589337 40 mg in Session Ia of Panel 1.
16263848|NCT00908414|Drug|TMC589337 100 mg|Participants will receive TMC589337 100 mg in Session IIa of Panel 1.
16263849|NCT00908414|Drug|TMC589337 200 mg|Participants will receive TMC589337 200 mg in Session IIIa of Panel 1.
16263850|NCT00908414|Drug|TMC589337 400 mg|Participants will receive TMC589337 400 mg in Session IVa of Panel 1.
16263851|NCT00908414|Drug|TMC589354 40 mg|Participants will receive TMC589354 40 mg in Session Ib of Panel 2.
16263852|NCT00908414|Drug|TMC589354 100 mg|Participants will receive TMC589354 100 mg in Session IIb of Panel 2.
16263853|NCT00908414|Drug|TMC589354 200 mg|Participants will receive TMC589354 200 mg in Session IIIb of Panel 2.
16263854|NCT00908414|Drug|TMC589354 400 mg|Participants will receive TMC589354 400 mg in Session IVb of Panel 2.
16263855|NCT00908414|Drug|TMC589337 AA mg|Participants will receive TMC589337 AA mg on Days 1 to 7 in Session Va of Panel 3.
16263856|NCT00908414|Drug|TMC589354 BB mg|Participants will receive TMC589354 BB mg on Days 1 to 7 in Session Vb of Panel 4.
16263857|NCT00908414|Drug|TMC589337 CC mg|Participants will receive TMC589337 CC mg on Days 1 to 7 in Session VIa of Panel 5.
16263858|NCT00908414|Drug|TMC589354 DD mg|Participants will receive TMC589354 DD mg on Days 1 to 7 in Session VIb of Panel 6.
16263859|NCT00908414|Drug|TMC589337 EE mg|Participants will receive TMC589337 EE mg on Days 1 to 7 in Session VII of Panel 7.
16263860|NCT00908414|Drug|TMC589354 YY mg|Participants will receive TMC589354 YY mg on Days 1 to 7 in Session VII of Panel 7.
16263861|NCT00908414|Drug|TMC310911 300 mg|Participants will receive TMC310911 300 mg in Panel 3, 4, 5, 6 and 7.
16263862|NCT00908414|Drug|TMC310911 600 mg|Participants will receive TMC310911 600 mg in Panel 7.
16263863|NCT00908414|Drug|Placebo|Participants will receive matching placebo to TMC589337 or TMC589354 in Panel 1 and 2.
16263864|NCT00908401|Other|Breastmilk|Breastmilk: 0.2 ml
16263865|NCT00908401|Other|Oral Sucrose|oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
16263866|NCT00908388|Device|GORE TAG® Thoracic Endoprosthesis|Endoprosthetic Implant
16263867|NCT00908375|Drug|Pregabalin|One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
16263868|NCT00908375|Drug|Sugar Pill|One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
16263869|NCT00908362|Drug|fluticasone|Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
16263870|NCT00908362|Drug|fluticasone/salmeterol|Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
16263871|NCT00908362|Drug|placebo|Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
16263872|NCT00908349|Drug|Oxcarbazepine XR|Open Label Study
16263873|NCT00908336|Drug|Docetaxel and Erlotinib|Docetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression
16263874|NCT00908336|Drug|Erlotinib|150 mg/day po daily
16263875|NCT00908323|Biological|JS7 DNA vaccine|
16263876|NCT00908323|Biological|MVA/HIV62 vaccine|
16263877|NCT00908310|Drug|Omniscan|OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.
16263878|NCT00908297|Dietary Supplement|Coenzyme Q10|"By mouth (wafer) once daily for duration of study (8 weeks).
~Dose escalation:
~300 mg for two weeks
~600 mg for two weeks
~1200 mg for two weeks
~1800 mg for final two weeks"
16263879|NCT00908284|Behavioral|Exercise Program|Participants will exercise in the study exercise laboratory for 1 hour on 2 nonconsecutive days a week for 12 weeks. The program will consist of a warm-up with flexibility exercises, aerobic conditioning, a muscular circuit, and a cool-down period with flexibility training.
16263880|NCT00908284|Behavioral|Control Group|Participants will attend group sessions once a week for 12 weeks to watch videos, including some exercise videos, and play games that do not require physical activity.
16263883|NCT00908245|Procedure|Preconditioning ischemia|Surgery with a preconditioning ischemia
16263885|NCT00908232|Drug|Bortezomib|1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8
16263886|NCT00908232|Drug|Dexamethasone|20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8
16263887|NCT00908232|Drug|Lenalidomide|10 mg orally daily, days 1-14 for cycles 5 to 8
16263888|NCT00908219|Drug|Bevacizumab|Bevacizumab is given as an IV infusion of 15 mg/kg every three weeks for 12 weeks.
16263889|NCT00908206|Drug|GSK598809|Subjects will receive a single 175 mg oral dose of GSK598809.
16263890|NCT00908193|Device|Laparoscopic DA VINCI Robot Assisted coelioscopy|Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
16263891|NCT00908193|Procedure|conventional coelioscopy|Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
16263892|NCT00908180|Biological|alemtuzumab|
16263893|NCT00908180|Biological|donor lymphocytes|
16263894|NCT00908180|Drug|carmustine|
16263895|NCT00908180|Drug|cyclosporine|
16263896|NCT00908180|Drug|cytarabine|
16263897|NCT00908180|Drug|etoposide|
16263898|NCT00908180|Drug|melphalan|
16263899|NCT00908180|Procedure|allogeneic hematopoietic stem cell transplantation|
16263900|NCT00908167|Drug|Sorafenib|Please see detailed description.
16263901|NCT00908167|Drug|Cytarabine|Please see Detailed Description.
16263902|NCT00908167|Drug|Clofarabine|Please see Detailed Description.
16263903|NCT00908154|Drug|Placebo|Tablets to match GSK1014802
16263904|NCT00908154|Drug|GSK1014802|Sodium channel blocker
16263905|NCT00908141|Biological|sargramostim|Given subcutaneously on varying schedule
16263906|NCT00908128|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 500 mg Tablet
16263907|NCT00908128|Drug|CellCept®|CellCept® Tablets, 500 mg
16263908|NCT00908115|Biological|GSK Biologicals' Infanrix™|Primary and booster vaccination according to vaccination schedule. Intramuscular injection
16263909|NCT00908102|Other|Moderate|A two level active intervention with a control group was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire.
16263910|NCT00908102|Other|Mild|A one level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Patients were selected by using a self-administered postal questionnaire.
16263911|NCT00908102|Other|Mild vs. NC|A two level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Intervention arms were compared to NC - no intervention group.
16263912|NCT00908102|Other|Moderate vs. NC|A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.
16263913|NCT00908089|Drug|Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab|methotrexate 10-25 mg/week, sulfasalazine 1-2 g/day, hydroxychloroquine 35 mg/kg/week, prednisolone 7.5 mg/day, and infliximab 3 mg/kg during first 6 months
16263914|NCT00908089|Drug|Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo|methotrexate 10-25 mg/week, sulfasalazine 1-2 g/day, hydroxychloroquine 35 mg/kg/week, prednisolone 7.5 mg/day, and placebo infusion during first 6 months
16263915|NCT00908076|Drug|LUBIPROSTONE|Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
16263916|NCT00908063|Drug|Oxycyte|A single dose of one of three dosage levels (dose escalating design), given by intravenous infusion at the rate of 15 mL/min (total duration expected to be between 5 and 20 minutes).
16263917|NCT00908063|Drug|Normal Saline|Normal saline will be administered as one of three volume doses based on cohort assignment (1.0 mL/min; 2.0 mL/min; 3.0 mL/min). The infusion will be administered at a rate of 15mL/min and will begin within 12 hours of injury.
16263918|NCT00908050|Drug|Botulinum toxin type A|"week 1: the patient will undergo the following: a. physical examination; b. sleep questionnaire c. bruxism questionnaire to establish a clinical diagnosis of bruxism; d. headache questionnaire; e. Clinical Global Improvement scale; f. masseter muscle measurement; g. anxiety questionnaire; h. demographic questionnaire;
~week 2: The patient undergoes a polysomnogram (sleep study). The patient will spend one night (10:30pm-8:00am or until spontaneous awakening) in a sleep lab. During the sleep study, the following parameters will be recorded: electroencephalogram, electro-oculogram, upper airway resistance, heart rate, muscle activity; upper airway resistance,masseter muscles bilaterally. All recordings are performed using surface electrodes (self-adhesive to the skin), none of them invasive.
~Study visit 3 (week 3): Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally."
16263919|NCT00908037|Drug|eltrombopag|thrombopoietin receptor agonist
16263920|NCT00908037|Drug|Placebo|placebo for comparison
16263921|NCT00908024|Drug|BMS-754807|Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision
16263922|NCT00908024|Drug|cetuximab (Erbitux®)|IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision
16263923|NCT00908011|Drug|Ezetimibe|10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks
16263924|NCT00908011|Drug|Rosuvastatin (standard care)|Increased dose of rosuvastatin to 20mg/day
16263925|NCT00907998|Drug|APL180|
16263926|NCT00907998|Drug|APL180|
16263927|NCT00907998|Drug|Placebo|
16263928|NCT00907985|Drug|Placebo|Single dose of placebo will be provided.
16263929|NCT00907985|Drug|Vofopitant|Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
16263930|NCT00907985|Drug|Lamotrigine|Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
16263931|NCT00907972|Dietary Supplement|Vitamin D3|Vitamin D3
16263932|NCT00907972|Other|Placebo|Placebo
16263933|NCT00907959|Drug|BZL101|Oral BZL101 20 grams/day (10 grams BID).
16264052|NCT00907036|Drug|fludarabine phosphate|
16264053|NCT00907036|Drug|melphalan|
16263934|NCT00907946|Procedure|NT 1 day before PCNL|"A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one day prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups:
~Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated.
~If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol."
16263935|NCT00907933|Drug|SB-705498|0.5mg intranasal SB-705498
16263936|NCT00907933|Drug|SB-705498|1.5mg intranasal SB-705498
16263937|NCT00907933|Drug|SB-705498|3mg intranasal SB-705498
16263938|NCT00907933|Drug|SB-705498|6mg intranasal SB-705498
16263939|NCT00907933|Drug|SB-705498|12mg intranasal SB-705498
16263940|NCT00907933|Drug|Placebo|Placebo '498
16263941|NCT00907933|Drug|SB-705498|6mg intranasal SB-705498 for 14 days bid
16263942|NCT00907933|Drug|SB-705498|12mg intranasal SB-705498 14 days bid
16263943|NCT00907933|Drug|Placebo|Placebo
16263944|NCT00907920|Other|laboratory biomarker analysis|Correlative studies
16263945|NCT00907907|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil Tablet 500 mg
16263946|NCT00907907|Drug|CellCept® Tablets|CellCept® Tablets, 500 mg
16263947|NCT00907894|Drug|LDT600 (Telbivudine)|LDT600 (Telbivudine)
16263948|NCT00907881|Drug|Sulfonylurea|The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.
16263949|NCT00907868|Radiation|partial breast irradiation|Patients undergo radiation tumor bed boost
16263950|NCT00907868|Radiation|whole breast irradiation|Patients undergo whole breast irradiation
16263951|NCT00907842|Device|Parietex Parastomal Mesh|mesh placed intraperitoneally around the stoma
16263952|NCT00907829|Drug|lidocaine|comparison of the effect of the drug to help improve finger function
16263953|NCT00907829|Device|muscle stimulator|comparison of the effect of stimulated muscle(s) on finger function
16263954|NCT00907803|Drug|ST-246 400 mg|Capsules, 400 mg daily for 14 days
16263955|NCT00907803|Drug|ST-246 600 mg|Capsules, 600 mg daily for 14 days
16263956|NCT00907803|Drug|Placebo|Capsules, once daily for 14 days
16263957|NCT00907790|Behavioral|Usual Care (Control Group)|
16263958|NCT00907790|Behavioral|Comprehensive Self-Management (CSM)|Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
16263959|NCT00907777|Biological|Pneumococcal conjugate vaccine GSK 1024850A|One dose of vaccine will be injected intramuscularly into the deltoid.
16263960|NCT00907777|Biological|Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)|One dose of vaccine will be injected intramuscularly into the deltoid.
16263961|NCT00907764|Drug|regadenoson|400 ug, IV
16263962|NCT00907751|Drug|rituximab|Patients will be treated according to the recommendations of the Reference Centre for the management of thrombotic microangiopathies. Infusions of rituximab (375 mg/m2) will be added to this treatment at day 1, 4 and 15, immediately after plasma exchange sessions.
16263963|NCT00907738|Drug|vorinostat|All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.
16263964|NCT00907725|Other|serum BhCG follow-up|Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
16263965|NCT00907725|Other|ultrasonographic follow-up|Subjects in this arm will receive medical abortion follow-up by ultrasound
16263966|NCT00907712|Other|cardiac echo examination|cardiac echo examination - before and after the surgery
16263967|NCT00907699|Genetic|DNA analysis|DNA is extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways.
16263968|NCT00907699|Genetic|RNA analysis|RNA is extracted from tumor samples. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263969|NCT00907699|Genetic|fluorescence in situ hybridization|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263970|NCT00907699|Genetic|gene expression analysis|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263971|NCT00907699|Genetic|mutation analysis|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16264054|NCT00907036|Procedure|allogeneic hematopoietic stem cell transplantation|
16264055|NCT00906997|Procedure|Immunochemical fecal occult blood test|Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
16264056|NCT00906997|Procedure|Colonoscopy|Every 10 years, with sedation.
16264057|NCT00906984|Device|TheraSphere|Given IV
16263972|NCT00907699|Genetic|polymerase chain reaction|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263973|NCT00907699|Genetic|reverse transcriptase-polymerase chain reaction|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263974|NCT00907699|Other|laboratory biomarker analysis|DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
16263975|NCT00907673|Device|Automatic Fluid Shunt System|Fully implantable peritoneal catheter, bladder catheter, and pump
16263976|NCT00907660|Behavioral|Weight loss counseling|Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
16263977|NCT00907660|Dietary Supplement|Portion-Controlled Foods|"Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. Full dose patients are provided with both meals by the study; half dose patients are provided with one out of two meals by the study."
16263978|NCT00907621|Procedure|Acupuncture with Seirin 020x15 mm sterile acupuncture needle|Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
16263979|NCT00907608|Drug|Darbepoetin alfa|Starting dose of 20 microgram per week, to be titrated over a 3-month period until target hemoglobin level is reached (female: 11 g/dL and male: 12 g/dL). Route of administration is subcutaneous injection.
16263980|NCT00907595|Drug|Ramelteon|After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
16263981|NCT00907595|Drug|Placebo|After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
16263982|NCT00907582|Procedure|autologous hematopoietic cell transplantation|"Autologous hematopoietic cell transplantation and condition with the following:
~idarubicin 15mg/m2•d day -11 and -10; busulfan 0.8mg/kg•q6h day -6 to -3."
16263983|NCT00907569|Radiation|Hypofractionated Chest Radiotherapy|Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.
16263984|NCT00907543|Other|Preoperative treatment of chemotherapy and radiation|Cisplatin + 5FU with concurrent radiation followed by surgery
16263985|NCT00907543|Other|Postoperative treatment of chemotherapy and radiation|Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation
16263986|NCT00907530|Drug|MULTIHANCE:|MULTIHANCE ® 0.5 M,0.1 mmol/kg
16263987|NCT00907530|Drug|GADOVIST|GADOVIST ® 1.0 M,0.1 mmol/kg
16263988|NCT00907517|Drug|MK-8776|IV infusion
16263989|NCT00907517|Drug|Cytarabine|IV infusion
16263990|NCT00907504|Drug|CP-751,871|CP-751,871 20mg/kg every 3 weeks
16263991|NCT00907504|Drug|Cisplatin|Cisplatin 80 mg/m2 every 3 weeks
16263992|NCT00907504|Drug|Gemcitabine|Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
16263993|NCT00907504|Drug|Cisplatin|Cisplatin 80 mg/m2 every 3 weeks
16263994|NCT00907504|Drug|Gemcitabine|Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
16263995|NCT00907491|Device|pulmonary sounds analyzer|Cough counting device based on the WIM Technology
16263996|NCT00907478|Biological|romiplostim|Romiplostim administered by subcutaneous injection
16263997|NCT00907452|Drug|melphalan-prednisone-thalidomide|
16263998|NCT00907452|Drug|lenalidomide-dexamethasone|
16263999|NCT00907426|Drug|Bimatoprost 0.03% solution|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
16264000|NCT00907426|Drug|Vehicle solution|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
16264001|NCT00907413|Procedure|ERCP and Photodynamic Therapy|Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
16264002|NCT00907413|Procedure|ERCP only|Endoscopic retrograde cholangiopancreatography and stenting.
16264003|NCT00907400|Drug|PN400|oral tablet
16264004|NCT00907400|Drug|Naproxen|oral tablet
16264005|NCT00907387|Drug|RT001|Dose A RT001
16264006|NCT00907387|Drug|RT001|Dose B RT001
16264007|NCT00907387|Other|Placebo|Dose C Placebo
16264008|NCT00907374|Drug|benazepril|benazepril 10 mg orally once daily
16264009|NCT00907374|Drug|benazepril|40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily
16264010|NCT00907361|Device|MRI with pacemaker or ICD|The aim of the present protocol is to prospectively determine the adverse event rate of non-thoracic MRI for patients with implanted cardiac devices by collecting pre- and post-MRI device interrogations in a multi-center registry.
16264099|NCT00906620|Other|QPR: question, persuade and refer (SEYLE)|"The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), key gatekeepers are people who regularly come into contact with individuals or families in distress and gatekeeper training has been identified as one of a number of promising prevention strategies."
16264011|NCT00907348|Drug|LR-CHOP21|"FIRST DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 5 mg/day D1-D14
~SECOND DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1;Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 10 mg/day D1-D14
~THIRD DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 15 mg/day D1-D14
~FOURTH DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 20 mg/day D1-D14 Repeated every 21 days"
16264012|NCT00907335|Drug|Retin-A Micro 0.04% facial acne treatment|Retin-A Micro 0.04% facial acne treatment used once daily
16264013|NCT00907335|Drug|Vehicle control|Color-matched facial gel vehicle control used once daily
16264014|NCT00907322|Drug|Dimebon|Oral tablet; 20 mg Dimebon, single dose
16264015|NCT00907322|Drug|Dimebon|Oral tablet; 40 mg Dimebon, single dose
16264016|NCT00907322|Drug|Dimebon|Oral tablet; 60 mg Dimebon, single dose
16264017|NCT00907322|Drug|Dimebon|Oral tablet; placebo, single dose
16264018|NCT00907309|Behavioral|iMET|Participants will receive the iMET intervention
16264019|NCT00907309|Behavioral|iMET/TE|Participants will receive the iMET intervention and also receive TEs (Technological Extenders)
16264020|NCT00907296|Biological|Romosozumab|Administered by subcutaneous injection
16264021|NCT00907296|Drug|Placebo|Administered by subcutaneous injection
16264022|NCT00907283|Drug|Deferiprone|15 mg/Kg/twice for 1 year
16264023|NCT00907270|Dietary Supplement|Cholecalciferol|Cholecalciferol: 4,000 IU/day and 400 IU/day
16264024|NCT00907257|Drug|benzoyl peroxide wash|5% benzoyl peroxide wash
16264025|NCT00907257|Drug|Tretinoin gel|0.04% tretinoin gel
16264026|NCT00907218|Drug|Varenicline (Chantix)|Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
16264027|NCT00907205|Drug|SF1126|Dose Escalating with 3+ patients in each cohort
16264028|NCT00907192|Behavioral|Personal Interview|Interview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete.
16264029|NCT00907192|Behavioral|Questionnaire|5 short questionnaires about use of pain drugs, attitudes about the pain drugs and their use, and concerns about use of these pain drugs. Take about 10-15 minutes to complete.
16264030|NCT00907179|Drug|LBH 589|"LBH589 three-times-a-week (doses will be at least 2 days apart, e.g. Monday, Wednesday, Friday), until disease progression or intolerable toxicities LBH589 will start the week prior to the first pemetrexed cycle and PD studies will be performed (week -1).
~Dose level: 1 LBH589: 10 mg Pemetrexed: 500 mg/m2
~Dose level: 2 LBH589: 15 mg Pemetrexed: 500 mg/m2
~Dose level: 3 LBH589: 20 mg Pemetrexed: 500 mg/m2
~Dose level: 4 LBH589: 30 mg Pemetrexed: 500 mg/m2"
16264031|NCT00907179|Drug|Pemetrexed|Pemetrexed 500mg/m2 IV, day 1, every 21 days, on the first day of the week LBH589 is given.
16264032|NCT00907166|Drug|CPI-613|IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients.
16264033|NCT00907166|Drug|CPI-613|IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma.
16264034|NCT00907166|Drug|Gemcitabine|IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
16264035|NCT00907166|Drug|Gemcitabine|IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients.
16264036|NCT00907166|Drug|Gemcitabine|IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
16264037|NCT00907153|Dietary Supplement|Vitamin D|Vitamin D 300 mcg by mouth once daily for 12 weeks
16264038|NCT00907153|Drug|Placebo|Placebo by mouth once daily for 12 weeks
16264039|NCT00907140|Procedure|Positron Emission Tomography|FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed
16264040|NCT00907127|Behavioral|Exercise and Diet (Metabolic Fitness Program)|6 month program of diet and exercise training and support.
16264041|NCT00907114|Drug|Ketorolac tromethamine|Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
16264042|NCT00907114|Drug|Polivynilic alcohol|Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
16264043|NCT00907101|Drug|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)|Apply once daily
16264044|NCT00907088|Other|Healthy milk intake|In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
16264045|NCT00907088|Other|Standard nutrition counselling|Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
16264046|NCT00907075|Behavioral|NES With Energy Restriction|The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.
16264047|NCT00907075|Behavioral|NES Without Energy Restriction|The NES will be administered based upon the individual's calculated daily energy requirement.
16264048|NCT00907062|Dietary Supplement|Ginkgo biloba|60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill
16264058|NCT00906971|Other|diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage|Exercises will be conducted by one physiotherapist. A one-minute rest period will be observed between each series. Isometric training of the abdominal muscles: This will consist of a contraction of the upper abdomen muscle and diaphragm and the simultaneous relaxation of the lower abdomen. Training will be carried out in two manners: with the patient lying in a left lateral decubitus position with the hip and knee flexed at 90º and sitting. Breathing exercises: With the patient in a seated position, with one hand placed on the abdomen and the other on the thorax, and will be instructed to breath in slowly,. Two series will be completed, with ten repetitions. Abdominal massage: The physiotherapist will perform slow circular clockwise movements, along the line of the colon, with a regular tennis ball, remaining on each point for one minute, beginning with the ascending colon moving in the direction of the sigmoid colon.
16264059|NCT00906958|Device|Nexus Flow Generator|The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.
16264060|NCT00906958|Device|VPAP Flow Generator 25|Exiting VPAP Auto 25 Flow Generator with A10 Algorithm
16264061|NCT00906945|Drug|G-CSF|
16264062|NCT00906945|Drug|Plerixafor|
16264063|NCT00906945|Drug|Mitoxantrone|
16264064|NCT00906945|Drug|Etoposide|
16264065|NCT00906945|Drug|Cytarabine|
16264066|NCT00906919|Behavioral|Regular diabetes patient education|Professionally-led diabetes patient education delivered by health professionals over a two day period
16264067|NCT00906919|Behavioral|Augmented diabetes patient education|Professionally-led diabetes patient education led by nurse and dietitian over a two day period augmented by participation in the Stanford Chronic Disease Self-Management Program. This program takes place for 2 1/2 hours per week for six consecutive weeks.
16264068|NCT00906906|Device|Doppler probes|Probes to be placed on CPB tubing to measure blood flow
16264069|NCT00906893|Procedure|18F]-FMISO PET-CT|pretherapy([18F]-FMISO) positon emission tomography-computed tomography. Different acquisition protocols will be tested and a wild panel of quantification parameters issued from published studies and original ones developed by our team enable to describe [18F]-FMISO uptake will be used.
16264070|NCT00906880|Drug|Nifurtimox-Eflronithine Combination Treatment (NECT)|co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID)
16264071|NCT00906867|Other|Methacholine challenge testing|Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
16264072|NCT00906867|Procedure|Rhino-laryngoscopy|Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.
16264073|NCT00906841|Drug|90Y-DOTA-hLL2|Consolidation : Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
16264074|NCT00906828|Drug|levodopa/carbidopa|intestinal gel, continuous infusion (daytime or 24-hour)
16264075|NCT00906828|Drug|entacapone|Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
16264076|NCT00906828|Drug|tolcapone|Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
16264077|NCT00906802|Procedure|R-Y reconstruction|The reconstruction was performed by R-Y anastomosis.
16264078|NCT00906789|Behavioral|Software|This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested
16264079|NCT00906776|Device|Emdogain PLUS|Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
16264080|NCT00906776|Device|Autogenous bone|Autogenous bone application during periodontal surgery
16264081|NCT00906763|Dietary Supplement|Chocolate|A single oral application of 200 grams of chocolate (85% cocoa for arm #1; 0% cocoa for arm #2).
16264082|NCT00906750|Biological|FluMist|FluMist is a live attenuated intranasal influenza vaccine
16264083|NCT00906750|Biological|Inactivated influenza vaccine|Inactivated influenza vaccine
16264084|NCT00906737|Device|Ankle-bot|The Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.
16264085|NCT00906737|Other|Conventional focused ankle therapy|Conventional focused ankle therapy will be performed by a physical therapist.
16264086|NCT00906724|Procedure|Aerobic exercise|"A graded exercise stress test (GXT) will be done under cardiologist supervision.
~Subjects will undergo three month of supervised aerobic exercise."
16264087|NCT00906698|Drug|BIBW 2992 low (20mg) dosage|Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
16264088|NCT00906698|Drug|BIBW 2992 medium (40mg) dosage|Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
16264089|NCT00906698|Drug|BIBW 2992 high (50mg) dosage|Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.
16264090|NCT00906698|Drug|Vinorelbine per os 60 mg/m²|Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15
16264091|NCT00906698|Drug|Vinorelbine per os 80 mg/m²|Patients will receive 80 mg/m² Vinorelbine per os at J22
16264092|NCT00906698|Drug|Vinorelbine i.v. 25 mg/m²|Patients will receive 25 mg/m² of Vinorelbine i.v.
16264093|NCT00906685|Drug|bevacizumab|Intravitreal injection of 1.25 mg bevacizumab
16264094|NCT00906685|Drug|Sham bevacizumab injection|Sham intravitreal injection
16264095|NCT00906672|Device|INTEGRA®|A plaque of dermal substitute Integra® is adjusted to the size of the wound and sutured. A negative pressure bandage is placed on the wound. 7 to 11 days post surgery, the Integra® silicone layer is removed and the neoderm is covered with a skin graft.
16264096|NCT00906672|Procedure|Flap technique|A flap is a part of skin, cutaneous tissue or muscle that is taken from an healthy area of the body and put on the damaged area for coverage.
16264097|NCT00906646|Dietary Supplement|Metabolic therapy|Coenzyme Q10 - 100 mg tds Magnesium orotate - 400 mg tds Lipoic acid - 100 mg tds Omega-3 fatty acids - 300 mg (in 1 g fish oils) tds Selenium - 200 µg
16264098|NCT00906646|Dietary Supplement|Placebo|Placebo tablets
16264100|NCT00906594|Drug|latanoprost|
16264101|NCT00906581|Behavioral|Computer-based Problem-Solving Treatment|6 sessions of problem-solving treatment delivered via computer
16264640|NCT00902473|Drug|Topiramate|25mg tablets
16264102|NCT00906555|Procedure|modification of hemodialysis parameters on dialysis machine|Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V ≥ 1.7.
16264103|NCT00906529|Drug|Levemir (Detemir) and Novolog (Aspart) Insulin|Will use individualized doses of levemir (detemir) and novolog (aspart) insulin to reach blood glucose goal
16264104|NCT00906516|Drug|Neuradiab in combination with Bevacizumab (Avastin)|"Patients will be treated following surgical removal of recurrent glioblastoma with a single intracavitary dose of Neuradiab® delivering 44 Gy±10% to the ridge of the surgically created resection cavity followed by therapy with Bevacizumab (Avastin) at a minimum of 30 days after Neuradiab administration.
~Treatment with Bevacizumab will consist of 10mg/kg iv on days 1 and 15 every 28 days. Other chemotherapies (in addition to Avastin) will be permitted based on most current clinical practice and clinical evaluation of the patient."
16264105|NCT00906503|Drug|dexamethasone|Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan
16264106|NCT00906503|Procedure|PET/Computed Tomography (CT)|Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
16264107|NCT00906503|Radiation|fludeoxyglucose (18F)|Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
16264108|NCT00906490|Device|Intravenous Blood Glucose monitoring system|Insertion of blood glucose monitoring sensor into peripheral vascular IV line.
16264109|NCT00906477|Procedure|Modified CI therapy|10 treatment days 3 hours a day: Shaping exercises 2 hours. Task practice 0,5 hours. Behavioral therapy (Transfer package) 0,5 hour. Encouragement to wear a restraining mitt on the least affected arm for all safe activities.
16264110|NCT00906451|Drug|Simvastatin|Simvastatin
16264111|NCT00906438|Dietary Supplement|2006-RD-05|300 mg daily, once a day for 28 consecutive days
16264112|NCT00906438|Dietary Supplement|Placebo|Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
16264113|NCT00906425|Device|Straumann Bone Level Implant|Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
16264114|NCT00906399|Drug|BIIB017 (peginterferon beta-1a)|Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
16264115|NCT00906399|Drug|Placebo|Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
16264116|NCT00906386|Drug|Varenicline|oral, 1 mg twice daily, 12 weeks
16264117|NCT00906386|Drug|placebo|oral, 1 mg twice daily, 12 weeks
16264118|NCT00906373|Biological|IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)|intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle
16264119|NCT00906373|Biological|IMC-A12 (cixutumumab) - 20 mg/kg|intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle
16264120|NCT00906373|Drug|Sorafenib|400 milligrams (mg) twice per day orally
16264121|NCT00906360|Drug|sunitinib malate|Given orally or by percutaneous gastrostomy tube
16264122|NCT00906360|Other|pharmacological study|Correlative studies
16264123|NCT00906360|Radiation|3-dimensional conformal radiation therapy|Undergo radiotherapy
16264124|NCT00906360|Biological|cetuximab|Given IV
16264125|NCT00906347|Drug|Misoprostol|75 micrograms orally every 4 hours for up to 2 doses.
16264126|NCT00906347|Drug|Oxytocin|Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
16264127|NCT00906334|Drug|ON 01910.Na|The original dosing regimen was 800 mg/m^2 ON 01910.Na.
16264128|NCT00906334|Drug|ON 01910.Na|Per Amendment 3 to the Protocol, the dosing regimen was changed to 1800 mg ON 01910.Na. Patients enrolled at the original dosing regimen could choose to remain in the original regimen or switch to the new regimen.
16264129|NCT00906321|Behavioral|Web-Based Decision Support|
16264130|NCT00906308|Drug|MF101 5 g/day|PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
16264131|NCT00906308|Drug|Placebo|PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
16264132|NCT00906308|Drug|MF101 10 g/day|PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
16264133|NCT00906295|Other|Allowed drop in hemoglobin to 4.5-5.5 mmol/L|Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)
16264134|NCT00906295|Other|Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L|Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)
16264135|NCT00906282|Drug|Pemetrexed|500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
16264136|NCT00906282|Drug|Carboplatin|AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
16264137|NCT00906269|Drug|Sildenafil therapy plus post-NSRRP HBO2T|Sildenafil (Viagra) 50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP hyperbaric oxygen therapy (90 minutes of 100% oxygen at 2.2ATA (equivalent to the pressure exerted at a depth of approximately 40 feet below sea level). There will be 5 or 10 treatments. The full treatment cycle will be completed within 2 weeks.
16264138|NCT00906269|Drug|Sildenafil therapy plus sham post-NSRRP HBO2T|Sildenafil (Viagra)50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP sham hyperbaric oxygen therapy - 90 minutes at 2.2ATA but instead of 100% oxygen, they will receive air administered via the oxygen hoods, as if they were being administered oxygen. Participants in this group will receive 5 or 10 sham treatment sessions. Full treatment cycle will be completed within 2 weeks.
16264139|NCT00906256|Drug|AZD7295|Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
16264140|NCT00906256|Drug|Placebo|Placebo
16264141|NCT00906243|Biological|CV9103|CV9103 encodes for 4 prostate specific antigens.
16264142|NCT00906204|Biological|Single-dose rabbit Anti-thymocyte Globulin induction|6 mg of rATG administered in a single dose on the day of kidney transplantation
16264143|NCT00906204|Biological|Divided-dose rabbit Anti-thymocyte Globulin induction|6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
16264144|NCT00906191|Drug|SAM-531|
16264145|NCT00906178|Behavioral|CyberSenga|Internet-based HIV prevention program
16264243|NCT00905333|Drug|Candesartan (test)|16 mg oral tablet, single dose
16264146|NCT00906165|Device|Straumann® Bone Level SLActive Implant (4.1mm diameter)|Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)
16264147|NCT00906139|Drug|Propofol|Propofol dose: 0.5 mg/kg up to 400 mg
16264148|NCT00906139|Drug|Midazolam|Midazolam dose: 0.1 mg/kg
16264149|NCT00906139|Drug|Fentanyl|Fentanyl dose: 0.05 mg
16264150|NCT00906126|Drug|Misoprostol|Oral misoprostol
16264151|NCT00906113|Drug|Intra-arterial injection of melphalan|Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses
16264152|NCT00906113|Drug|Injection of melphalan into the ophthalmic artery|Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma
16264153|NCT00906087|Drug|Cosopt (combination eyedrop of dorzolamide and timolol)|One drop in each eye every twelve hours for six weeks
16264154|NCT00906074|Procedure|Elective or emergency abdominal surgery|Clinical record review.
16264155|NCT00906074|Procedure|Elective or emergency abdominal surgery|Clinical record review
16264156|NCT00906061|Drug|Gemcitabine and Docetaxel|Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6
16264157|NCT00906048|Drug|Levofloxacin (HR355) and Rifampicin Therapy|"Film-coated scored tablet measured at 500 mg of levofloxacin and capsule at 300 mg of rifampicin per os once a day
~Weight < 70 kg: 1 tablet of levofloxacin and 2 capsules of rifampicin Weight > 70 kg: 1 tablet of levofloxacin and 3 capsules of rifampicin"
16264158|NCT00906035|Drug|Dipyridamole 200mg and Aspirin 25mg bid:|All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
16264159|NCT00906035|Drug|Dipyridamole 200 mg bid|All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
16264160|NCT00906035|Drug|Aspirin 25 mg bid|All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
16264161|NCT00906022|Device|Astron Pulsar Stent|Stenting with Astron Pulsar
16264162|NCT00906022|Device|PTA alone|Balloon angioplasty alone
16264163|NCT00905996|Procedure|Endoscopic cyanoacrylate injection|Endoscopic cyanoacrylate injection in gastric varix
16264164|NCT00905996|Drug|Beta-blocker (propranolol)|
16264165|NCT00905983|Drug|Gemcitabine and Docetaxel|Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6
16264166|NCT00905957|Procedure|TAP block|TAP block using 20 ml of a local anaesthetic agent will be used in the treatment group
16264167|NCT00905957|Procedure|TAP block with placebo|TAP block using a placebo after induction of anaesthesia
16264168|NCT00905944|Other|Endurance exercise|The patients carry out an exercise program (walking on a treadmill) three times weekly for 12 weeks at a speed corresponding with an intensity of 70% of VO2max.
16264169|NCT00905931|Drug|Lycopene|30 mg oral, daily, for 21 days
16264170|NCT00905931|Drug|placebo|starch
16264171|NCT00905918|Dietary Supplement|vitamin E|Given orally
16264172|NCT00905918|Other|laboratory biomarker analysis|All patients undergo biomarker analyses
16264173|NCT00905905|Drug|Simvastatin|Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
16264174|NCT00905905|Drug|Ezetimibe-Simvastatin|Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
16264175|NCT00905892|Dietary Supplement|Hyperlipidic overfeeding|100g per day of cheese + 40g per day of almonds + 20g per day of butter
16264176|NCT00905879|Drug|Gadobutrol (Gadovist, BAY86-4875)|Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)
16264177|NCT00905866|Other|PAS and SF-36 questionnaires|Patients who agree to participate in this study will be asked to fill out a translated PAS questionnaire and a Taiwan version of SF-36 before and after surgery
16264178|NCT00905853|Procedure|Catheter Ablation|Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.
16264179|NCT00905853|Drug|Escalated Antiarrhythmic Therapy|"Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter.
~Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter.
~Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day"
16264180|NCT00905840|Device|Titanium Zircon implant|"The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants.
~The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing."
16264181|NCT00905840|Device|Titanium Grade IV implant|"The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants.
~The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing."
16264182|NCT00905827|Behavioral|CAMS|Collaborative assessment management in suicidality
16264183|NCT00905814|Drug|AG-013736|single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
16264184|NCT00905814|Drug|AG-103736|single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
16264244|NCT00905333|Drug|Felodipine (test)|5 mg oral extended release tablet, single dose
16264725|NCT00901979|Drug|LCQ908A|
16264185|NCT00905801|Other|CT Perfusion|Subjects will be examined with a CTP Imaging protocol which comprises repeated CT-scans of the tumor over a period of 50 seconds following the injection of a 30cc bolus of an FDA-approved low osmolar, iodinated CT contrast agent using a 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI). One scan will be acquired every 3 seconds over a 50s period at 100 kV, and 100mA tube current. With this method, a 4cm long segment of the tumor can be analyzed, and 32 images of a slice thickness of 1.25 mm reconstructed simultaneously. Images will be evaluated using standard CT blood flow software (Perfusion 2, AW, GE Health Care, Milwaukee, WI).
16264186|NCT00905788|Procedure|prevention of embryo expulsion|The prevention of embryo expulsion will be carried out after embryo transfer
16264187|NCT00905762|Drug|Gatifloxacin|Gatifloxacin 0.3% one drop instilled into study eye at visit 2.
16264188|NCT00905762|Drug|Moxifloxacin|Moxifloxacin 0.5% one drop instilled into study eye at visit 2.
16264189|NCT00905762|Drug|Besifloxacin|Besifloxacin 0.6% one drop instilled into study eye at visit 2.
16264190|NCT00905736|Procedure|Microcurrent treatment (controlled current)|primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
16264191|NCT00905736|Procedure|Micocurrent treatment (controlled voltage)|Microcurrent delivered for 6 hours daily for 3 weeks
16264192|NCT00905723|Drug|estradiol|1 mg daily for 6 months
16264193|NCT00905723|Drug|isoflavone|150 mg isoflavone daily for 6 months
16264194|NCT00905723|Drug|Placebo|sugar pill daily for six months
16264195|NCT00905710|Procedure|Chromoendoscopy|Chromoendoscopy: spraying of the mucosa of the right colon with indigo-carmine
16264196|NCT00905697|Procedure|Living donor lung transplantation|Living donor lung transplantation
16264197|NCT00905684|Drug|EE30/DRSP (Yasmin, BAY86-5131)|Patients under regular daily life treatment receiving Yasmin according to local drug information
16264198|NCT00905684|Drug|Any other OC|Patients under regular daily life treatment receiving any other OC according to local drug information
16264199|NCT00905671|Device|LipiScan Coronary Imaging Catheter|Intravascular near infrared spectroscopic imaging of the coronary artery with a fiberoptic catheter.
16264200|NCT00905658|Dietary Supplement|therapeutic nutritional supplementation|Patients receive systematic nutritional supplementation
16264201|NCT00905658|Procedure|standard follow-up care|Patients undergo standard monitoring
16264202|NCT00905645|Device|Silimed Gel-Filled Mammary Implant|
16264203|NCT00905632|Drug|BI 207127 middle dose +SOC|BI 207127 middle dose tid + SOC
16264204|NCT00905632|Drug|BI 207127 high dose+SOC|BI 207127 high dose tid +SOC
16264205|NCT00905632|Drug|Placebo + SOC|Placebo tid +SOC
16264206|NCT00905632|Drug|BI 207127 low dose + SOC|BI 207127 low dose tid + SOC
16264207|NCT00905606|Drug|Topiramate Tablets|
16264208|NCT00905606|Drug|Topamax® Tablets|
16264209|NCT00905593|Drug|Nilotinib|
16264210|NCT00905580|Drug|Pregabalin|Pregabalin 150 mg orally
16264211|NCT00905580|Drug|Vitamin Complex (placebo)|Vitamin Complex 150 mg orally
16264212|NCT00905567|Drug|Topiramate 2 x 25 mg tablet|
16264213|NCT00905567|Drug|Topamax® Tablet 2 x 25 mg|
16264214|NCT00905554|Procedure|warm water irrigation|warm water irrigation during insertion phase of colonoscopy
16264215|NCT00905554|Procedure|air insufflation|air insufflation during the insertion phase of colonoscopy
16264216|NCT00905541|Drug|simvastatin|40 mg/day
16264217|NCT00905541|Drug|simvastatin|80 mg simvastatin acute-on-chronic
16264218|NCT00905528|Drug|Telmisartan 80 mg/d|
16264219|NCT00905528|Drug|Ramipril 10 mg/d|
16264220|NCT00905515|Drug|cyclosporine|Maintain on cyclosporine at target trough level of 50-250 ng/mL.
16264221|NCT00905515|Drug|Prograf (Tacrolimus)|Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
16264222|NCT00905502|Drug|Lactated Ringer's solution|Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period
16264223|NCT00905502|Drug|Lactated Ringer's solution|patients in the LG received 10 ml/kg•hr of RL solution intraoperatively
16264224|NCT00905489|Drug|Nevirapine Immediate Release (IR)|200 mg Tablet or 50 mg / 5 ml oral suspension
16264225|NCT00905489|Drug|Nevirapine Extended Release (XR)|200 mg, 300 mg or 400 mg Tablet formulation
16264226|NCT00905463|Procedure|Lung transplantation|Lung transplantation
16264227|NCT00905450|Drug|BOL-303242-X|Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.
16264228|NCT00905450|Drug|Vehicle for BOL-303242-X|Medication instilled into the study eye, subjects randomized to various drug dose schedules.
16264229|NCT00905437|Drug|Placebo|Placebo as an adjunct to standard of care
16264230|NCT00905437|Drug|Pregabalin|75 mg BD for 14 days
16264231|NCT00905424|Drug|Antidepressant + SPD489 (lisdexamfetamine dimesylate)|Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
16264232|NCT00905424|Drug|Antidepressant + placebo|Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
16264233|NCT00905411|Behavioral|PacDASH intervention|"Effect of the PacDASH intervention on nutrition and physical activity behavior of children.
~15 months study."
16264234|NCT00905398|Drug|Nilotinib|400mg, Oral, Bid, Daily for three years
16264235|NCT00905385|Biological|NTHi Strain 2019|Nontypeable Haemophilus influenzae (NTHi) strain 2019 StrR Number 1 is an antibiotic susceptible clinical strain that has a point mutation in the rRNA that renders the isolate resistant to streptomycin. This agent will be introduced by nasal droplets.
16264236|NCT00905372|Drug|LY2062430|400 mg intravenously (IV) every 4 weeks for 80 weeks
16264237|NCT00905372|Drug|Placebo|intravenously (IV) every 4 weeks for 80 weeks
16264238|NCT00905359|Procedure|Aperius™ PercLID™ System|Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
16264239|NCT00905359|Procedure|Standalone Decompressive Surgery|Lumbar decompressive surgery without instrumentation or fusion
16264240|NCT00905346|Drug|Topiramate 25 mg Capsules|Topiramate Capsules 2 x 25 mg
16264241|NCT00905346|Drug|Topamax® 25 mg Capsules|Topamax® Capsule 2 x 25 mg
16264242|NCT00905346|Other|Applesauce|Applesauce
16264324|NCT00904800|Drug|Placebo|Placebo
16264245|NCT00905333|Drug|Candesartan Cilexetil|16 mg oral tablet, single dose
16264246|NCT00905333|Drug|Felodipine|5 mg oral extended release tablet, single dose
16264247|NCT00905320|Procedure|Metallic Fasteners and Sutures|Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
16264248|NCT00905320|Procedure|Metallic Fasteners Alone|Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.
16264249|NCT00905307|Drug|OPC-34712|oral, once daily
16264250|NCT00905307|Drug|Placebo|Placebo
16264251|NCT00905307|Drug|Aripiprazole|oral, once daily
16264252|NCT00905294|Other|Blood draws|Observational: blood draws only
16264253|NCT00905281|Other|Action Group|"On inclusion, a visit will be organized between the patient and at least 2 members of the DISSPO staff. It will allow an evaluation of supportive care needs and the proposition of a personalized care plan.
~Then, a consultation between the referring oncologist and the DISSPO will be organized once a month, so that the personalized care plan could be adapted if necessary."
16264254|NCT00905281|Other|Standard care|No specific intervention
16264255|NCT00905268|Drug|idebenone|12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
16264256|NCT00905268|Drug|Placebo|12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
16264257|NCT00905255|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16264258|NCT00905255|Device|Pen auto-injector|
16264259|NCT00905242|Drug|GI medication|Patients on daily dosing were asked to discontinue their GI medication at baseline. Patients on twice daily dosing were asked to reduce GI medication to once a day at baseline and asked to discontinue GI medication at day 30.
16264260|NCT00905229|Drug|Phytonadione|2.5 mg po
16264261|NCT00905229|Drug|Phytonadione|0.5 mg IV
16264262|NCT00905216|Drug|heparin sodium - Bergamo|5.000 UI/mL
16264263|NCT00905216|Drug|heparin sodium - APP|5.000 USP
16264264|NCT00905203|Other|exercise|exercise training
16264265|NCT00905190|Drug|Ondansetron|24 mg one time
16264266|NCT00905164|Drug|Topiramate Capsules, 25 mg|Topiramate Capsules, 2 x 25 mg
16264267|NCT00905164|Drug|Topamax® Capsules, 25 mg|Topamax® Capsules, 2 x 25 mg
16264268|NCT00905138|Drug|GLPG0259|single ascending doses, oral solution
16264269|NCT00905138|Drug|placebo|single dose, oral solution
16264270|NCT00905138|Drug|GLPG0259|multiple dose, oral solution, 5 days
16264271|NCT00905138|Drug|placebo|oral solution, 5 days
16264272|NCT00905125|Biological|Fluzone®|Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluzone® does not contain thimerosal.
16264273|NCT00905125|Biological|Fluarix®|Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluarix® contains less than 1 microgram (trace or a very small amount) thimerosal per shot.
16264274|NCT00905112|Other|Manual Therapy|Receives manual therapy, stabilization exercise and patient education
16264275|NCT00905112|Other|Standard OB Care|Receive standard obstetrical care
16264276|NCT00905086|Other|questionnaire administration|Two weeks before completing planned radiotherapy, patients undergo assessment of stress appraisal and other factors predictive of post-radiotherapy psychosocial adjustment. At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.
16264277|NCT00905086|Procedure|cognitive assessment|Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index).
16264278|NCT00905086|Procedure|psychosocial assessment and care|Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index).
16264279|NCT00905086|Procedure|quality-of-life assessment|At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.
16264280|NCT00905073|Drug|cyclosporin and methotrexate|cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year. After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.
16264281|NCT00905060|Biological|HSPPC-96|Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
16264282|NCT00905060|Drug|Temozolomide|Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.
16264283|NCT00905060|Procedure|Standard Surgical Resection|Patients will undergo standard surgical resection of intracranial tumor
16264284|NCT00905047|Drug|XELODA|"XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days.
~Cycle treatment duration : 21 days"
16264285|NCT00905047|Drug|TEGAFUR URACIL - FOLINIC ACID|"Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.
~Duration of treatment cycle : 35 days."
16264286|NCT00905034|Drug|Methotrexate|200 mg/m^2 by vein on days 1 and 15.
16264287|NCT00905034|Drug|Vincristine|1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.
16264288|NCT00905034|Drug|PEG-l-asparaginase|2500 International units/m^2 by vein on days 2 and 16
16264289|NCT00905034|Drug|Dexamethasone|40 mg by vein or by mouth daily days 1-4 and 15-18.
16264290|NCT00905034|Drug|Rituximab|Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.
16264291|NCT00905021|Drug|Exemestane|Exemestane 25 mg by mouth every day.
16264292|NCT00905021|Drug|Sutent|Sunitinib 37.5 mg by mouth every day.
16264293|NCT00905008|Procedure|transluminal percutaneous coronary intervention|All interventions were done according to current practice guidelines. The operator was responsible for the decision to choose a specific treatment strategy. Angiographic success was defined as residual stenosis <30% by visual analysis in the presence of TIMI 3 flow grade. The patients were prescribed aspirin plus clopidogrel 75 mg per day, after a loading dose of 300 mg or 600 mg, before or during the index coronary intervention. After procedure, all patients were advised to maintain lifelong use of aspirin. The use of clopidogrel (75 mg per day) was always adapted according to guideline recommendations. Heparin was infused throughout the procedure to maintain an activated clotting time of at least 250 sec. The administration of platelet glycoprotein IIb/IIIa receptor blocker was encouraged, unless in existing contraindications.
16264294|NCT00905008|Device|Drug-Eluting and Bare-Metal stents|Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents
16264295|NCT00904995|Drug|Voriconazole|Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
16264296|NCT00904995|Drug|Voriconazole|6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
16264297|NCT00904982|Behavioral|Financial Incentive and Med-eMonitor|"Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.
~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server."
16264298|NCT00904982|Device|2Med-eMonitor|Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.
16264299|NCT00904969|Device|The AMS Male Transobturator Sling System|The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
16264300|NCT00904969|Device|AdVance Male Sling|A transobturator sling for the treatment of post-prostatectomy incontinence
16264301|NCT00904943|Drug|Topiramate Capsules, 25 mg|2 x 25 mg Capsules
16264302|NCT00904943|Drug|Topamax® Capsules, 25 mg|2 x 25 mg Capsules
16264303|NCT00904930|Device|Wire Composite Splint (Dentaflex 0.45 mm)|Wire-Composite-Splint: Dentaflex 0.45 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow (IvoclarVivadent, Schaadn, Liechtenstein) to the teeth
16264304|NCT00904930|Device|Wire Composite Splint (Denture Strengtheners)|Wire-Composite-Splint: Denture Strengtheners 0.8x1.8 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow to the teeth
16264305|NCT00904917|Behavioral|Prevention Intervention Project|Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.
16264306|NCT00904917|Behavioral|Psychoeducation|Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
16264307|NCT00904904|Drug|Indomethacin ophthalmic solution|Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
16264308|NCT00904904|Drug|Ketorolac Ophthalmic Solution|Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery
16264309|NCT00904891|Behavioral|Cognitive-behavioral group|Six sessions of cognitive-behavioral depression prevention group intervention
16264310|NCT00904891|Behavioral|Cognitive-behavioral bibliotherapy|"Cognitive-behavioral bibliotherapy, delivered from the book Feeling Good"
16264311|NCT00904865|Procedure|SPA cholecystectomy|SPA cholecystectomy
16264312|NCT00904865|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy
16264313|NCT00904852|Drug|Tandutinib, bevacizumab, and temozolomide|All patients will have completed treatment with concurrent radiation therapy and temozolomide. Patients will be entered into different dosing groups of tandutinib. Patients will receive up to 6 cycles of treatment with oral temozolomide at 150 mg/m2 daily for the first 5 days of a 28 day cycle, oral tandutinib at escalating doses 250, 375, 500, or 625 mg twice daily on days 1 to 28, and intravenous bevacizumab at 10 mg/kg on days 1 and 15 of each cycle
16264314|NCT00904839|Drug|BIBF 1120|BIBF 1120 100 and 150 mg capsules
16264315|NCT00904839|Drug|BIBF 1120|BIBF 1120 100 and 150 mg capsules
16264316|NCT00904839|Drug|mFolfox|standard i.v chemotherapy
16264317|NCT00904839|Drug|Bevacizumab|100 mg/Kg solution , IV infusion
16264318|NCT00904839|Drug|mFolfox 6|IV standard chemotherapy
16264319|NCT00904839|Drug|bevacizumab|100 mg/4 ml solution
16264320|NCT00904826|Drug|Eculizumab|"The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks.
~The first infusion will be given at Mayo Clinic site; subsequent infusions will be administered in the subject's home by a company which will send a nurse to administer the infusion. Subjects will receive therapy for a total of 12 months."
16264321|NCT00904813|Radiation|Short-course RT|Preoperative radiotherapy (RT) given 5 times 5 Gray during five consecutive days, preferably Monday - Friday, with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
16264322|NCT00904813|Radiation|Long-course RT|Preoperative radiotherapy (RT) given 2 Gy in 25 fractions during 5 weeks, total dose 50 Gy with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
16264323|NCT00904800|Drug|AZD0837|tablet, oral, once daily, 1+5 days
16264325|NCT00904787|Drug|ENMD-2076|capsule, dose escalation, taken orally, daily in 28 day cycles
16264326|NCT00904761|Other|exercise training|The exercise group took supervised aerobic training twice per week at hospital and thrice per week at home for eight weeks at the intensity of 60-70% VO2peak
16264327|NCT00904748|Drug|sildenafil citrate 100 mg CT|sildenafil citrate 100 mg CT, single dose without water
16264328|NCT00904748|Drug|sildenafil citrate 100 mg CT|sildenafil citrate 100 mg CT, single dose with water
16264329|NCT00904748|Drug|Viagra®|sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
16264330|NCT00904735|Drug|hydroxyurea|Given orally
16264331|NCT00904735|Drug|imatinib mesylate|Given orally
16264332|NCT00904722|Drug|CT-011|Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days).
16264333|NCT00904722|Drug|Rituximab|Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
16264334|NCT00904709|Drug|tranexamic acid|After The starting dose of tranexamic acid will be 500 mg twice daily beginning the first day of menstrual flow for a total of 6 days per menstrual cycle. If after 2 days there is still menorrhagia without significant side effects the will be increased. The women will be assessed again at day 4 and 9 and dose escalation will continue until they have reached the optimal dose.The dose of tranexamic acid will be increased as follows: 1000 mg twice daily, 1000 mg three times daily, 1500 mg/1000 mg/1000 mg, 1000 mg four times daily, 1500 mg three times daily, and 1500 mg four times daily (maximum dose).Each patient will be followed for a minimum of one menstrual cycle and a maximum of 3 cycles.
16264335|NCT00904683|Drug|LY2062430|400 mg intravenously (IV) every 4 weeks for 80 weeks
16264336|NCT00904683|Drug|Placebo|intravenously (IV) every 4 weeks for 80 weeks
16264337|NCT00904670|Drug|Quillivant Oral Suspension XR|Oral Suspension 25mg/5mL; 20-60 mg/day
16264338|NCT00904670|Drug|Placebo|Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day
16264339|NCT00904670|Drug|Placebo|Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.
16264340|NCT00904657|Drug|sunitinib (Sutent)|50 mg capsule Sutent, one application a day for five days
16264341|NCT00904644|Drug|Raltegravir|Raltegravir standard dosage of 400mg tablets every 12 hours together with an optimized backbone antiretroviral drug regimen
16264342|NCT00904631|Device|Eraser device+ salicylic acid (5%)|Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection).
16264343|NCT00904618|Procedure|TVT-SECUR - 'Hammock' technique|The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.
16264344|NCT00904618|Procedure|TVT-SECUR - 'U-Method'|The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.
16264345|NCT00904618|Drug|Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).|Local anesthesia consisted of 30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%. Sedation was used in association with local anesthesia, including 1 mg of lorazepam sublingual as well as a combination of 0.5 to 2 mg intravenous (IV) of midazolam and 50 to 200 ug IV of fentanyl. Postoperative analgesia consisted of a prescription of 30 tablets of morphine 5 mg.
16264346|NCT00904605|Drug|Lidoderm|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine patch 5% or celecoxib 200 mg daily. Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h
16264347|NCT00904605|Drug|Celecoxib|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine patch 5% or celecoxib 200 mg daily. Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h)
16264348|NCT00904592|Drug|Qi ming granula|Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
16264349|NCT00904592|Drug|Placebo Comparator|"Control group: Basic therapy ＆ placebo
~Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education.
~placebo,Usage: 4.5g，po，tid"
16264350|NCT00904553|Radiation|Novalis Shaped Beam Surgery|Treatment using Novalis SRS
16264351|NCT00904540|Drug|Lidoderm®|Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP)
16264352|NCT00904527|Behavioral|relaxation (Schultz)|Patients have relaxation consultations during 2 months
16264353|NCT00904514|Genetic|gene expression analysis|
16264354|NCT00904514|Genetic|microarray analysis|
16264355|NCT00904514|Genetic|mutation analysis|
16264356|NCT00904514|Genetic|polymerase chain reaction|
16264357|NCT00904514|Other|flow cytometry|
16264358|NCT00904514|Other|immunoenzyme technique|
16264359|NCT00904514|Other|laboratory biomarker analysis|
16264360|NCT00904501|Procedure|Bone marrow harvest|Implantation of placebo
16264361|NCT00904501|Procedure|Bone marrow harvest|Implantation of bone marrow - mononuclear cells
16264362|NCT00904488|Drug|Addition of oral Metolazone|Addition of oral metolazone 5 mg daily to continued current dose of intravenous bolus furosemide
16264533|NCT00903162|Drug|letrozole|Taken orally once a day 6-8 weeks after initial leuprolide administration
16264726|NCT00901979|Drug|LCQ908A|
16264363|NCT00904488|Drug|Furosemide dose escalation|Furosemide dose escalation via either IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
16264364|NCT00904475|Drug|Lidoderm®|Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
16264365|NCT00904475|Drug|Lidoderm®|Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
16264366|NCT00904462|Drug|Lidoderm|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
16264367|NCT00904462|Drug|Placebo patch|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
16264368|NCT00904449|Drug|Oxymorphone ER|10mg, 20mg, and 40mg PO
16264369|NCT00904436|Drug|ipratropium (Atrovent)|Bronchodilator Treatment: Subjects will inhale 1 unit dose vial of aerosolized ipratropium (500 mcg of ipratropium (Atrovent) mixed in 2.5 ml of saline).
16264370|NCT00904423|Drug|Vitamin D|up to 2400 mg; oral tablet
16264371|NCT00904410|Other|FDG-PET|370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle
16264372|NCT00904397|Drug|Lidoderm®|Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
16264373|NCT00904397|Drug|Celecoxib|Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
16264374|NCT00904358|Diagnostic Test|cross sectional area|
16264375|NCT00904345|Drug|Cetuximab|Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.
16264376|NCT00904345|Radiation|50-60 Gy and 70 Gy|Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.
16264377|NCT00904319|Other|Aquatic Power Training|Aquatic power training program with an exercise specialist 2/week for 6 weeks.
16264378|NCT00904306|Dietary Supplement|Sugar Pill|placebo oral tablet taken once per day
16264379|NCT00904306|Dietary Supplement|chromium picolinate|1000 ug/day chromium picolinate for 6 months
16264380|NCT00904306|Dietary Supplement|chromium picolinate|600 ug/day chromium picolinate
16264381|NCT00904293|Other|Genotype-guided dose determination|Patients in both arms will be treated with warfarin. Those in the experimental group will have initial doses determined using an algorithm (from www.warfarindosing.org) incorporating genetic and clinical factors. Those in the control group will have doses determined using the same algorithm, but without including the genetic factors.
16264382|NCT00904293|Other|Non-genotype guided warfarin dosing|Those in the control group will have doses determined using the same algorithm, but without including the genetic factors.
16264383|NCT00904280|Drug|Oxymorphone ER|Open label
16264384|NCT00904254|Radiation|EP 1645/Solution For Injection, 99mTC|(Fab-fragment of Anti-human CD4,technetium-99m)
16264385|NCT00904241|Other|Cytology Specimen Collection Procedure|Correlative studies
16264386|NCT00904241|Other|Laboratory Biomarker Analysis|Correlative studies
16264387|NCT00904228|Other|placement of plastic cap during delivery room stabilization|placement of plastic cap during delivery room stabilization
16264388|NCT00904228|Other|placement of routine cap during delivery room stabilization|
16264389|NCT00904215|Drug|telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)|
16264390|NCT00904202|Drug|Placebo Capsules + Placebo Patch|Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
16264391|NCT00904202|Drug|Placebo capsules + Lidoderm®|Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
16264392|NCT00904202|Drug|Gabapentin + Placebo|Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
16264393|NCT00904202|Drug|Gabapentin + Lidoderm®|Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
16264394|NCT00904202|Drug|Gabapentin 300 mg capsules 1800 mg/day + placebo patch|Gabapentin 300 mg capsules 1800 mg/day + placebo patch
16264395|NCT00904202|Drug|Gabapentin 1800 mg/day + Lidoderm patch|
16264396|NCT00904189|Radiation|Standard of care given for treatment of cancer|Subjects receiving a known dose of radiation during Total Body Irradiation.
16264397|NCT00904176|Drug|Dapagliflozin|Tablets, Oral, 20 mg, followed by 10 mg, Single Dose
16264398|NCT00904176|Drug|Warfarin|Tablets, Oral, 25 mg, Single Dose
16264399|NCT00904176|Drug|Digoxin|Tablets, Oral, 0.25, Single Dose
16264400|NCT00904137|Procedure|Cast|
16264401|NCT00904137|Procedure|Splint|
16264402|NCT00904137|Procedure|Tape|
16264403|NCT00904124|Dietary Supplement|cellulose, alginate, guar gum|6 different food products are developed with different dosages of dietary fiber. Regular flour is replaced by dietary fiber, dosages are described in the 'arms'section.
16264404|NCT00904111|Drug|Lidoderm®|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
16264405|NCT00904111|Drug|Placebo Topical Patch|Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
16264406|NCT00904098|Drug|Frovatriptan|"This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases:
~A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol)
~An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period."
16264407|NCT00904098|Drug|Usual Care|Current treatment used to treat all migraine headaches
16264408|NCT00904085|Drug|Oxymorphone IR|5 mg
16264409|NCT00904059|Drug|BMS-650032|Capsules, Oral, 600 mg, Q12h, Days 1-7
16264410|NCT00904059|Drug|BMS-790052|Capsules, Oral, 60 mg, Q24h, Days 1-7
16264411|NCT00904059|Drug|BMS-650032|Capsules, Oral, 200 mg, Q12h, Days 8-21
16264412|NCT00904059|Drug|BMS-790052|Capsules, Oral, 30 mg, Q24h, Days 8-21
16264413|NCT00904046|Drug|Pioglitazone|30 mg orally daily for 6 months
16264414|NCT00904046|Drug|Placebo|Placebo taken orally once a day for 6 months.
16264415|NCT00904033|Drug|Calcitriol|Calcitriol tablet taken once per week.
16264416|NCT00904033|Behavioral|Exercise|Exercise consisting of progressive walking and resistance band training
16264417|NCT00904033|Dietary Supplement|Multivitamin|
16264418|NCT00904020|Drug|Lidoderm|Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.
16264419|NCT00904007|Other|Interactive Spaced Education (ISE) --- online education|"ISE is a novel educational methodology based on the spacing effect, the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions."
16264420|NCT00903994|Drug|Ketoprofen Topical Patch 20%|Ketoprofen is a pressure-sensitive adhesive material containing 20% Ketoprofen which is applied to a polyester textile and covered with a foil release liner.for the treatment of mild to moderate acute pain associated with Tendonitis or Bursitis of the shoulder, elbow or knee
16264421|NCT00903981|Drug|Avanafil|2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
16264422|NCT00903981|Drug|Avanafil|2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse
16264423|NCT00903981|Drug|Placebo|2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
16264424|NCT00903968|Drug|Plerixafor|
16264425|NCT00903968|Drug|bortezomib|
16264426|NCT00903968|Drug|Dexamethasone|
16264427|NCT00903955|Other|7% hypertonic saline|Administered via jet nebulizer to subjects in specific aim 3
16264428|NCT00903942|Radiation|radiation therapy|1) PTV = CTV (GTV + 1.5-cm margins and the most adjacent nodal regions) + 0.5 cm margins to 5,040 cGy in 180 cGy daily fractions; and (2) Cone Down PTV = GTV +1.5 cm margins to 6,480 cGy.
16264429|NCT00903942|Drug|Paclitaxel Protein-Bound, and CARBOPLATIN|Induction Chemotherapy Abraxane(260 mg/m2) / Carboplatin (AUC of 6) x one cycle Concurrent Chemotherapy(with radiation)--for first 3 pts--20 mg/m2 Abraxane, 3 times per week then for next group of 3 pts--30 mg/m2 Abraxane twice a week
16264430|NCT00903929|Drug|Eltrombopag|dose escalation
16264431|NCT00903890|Other|Survey|Survey asking questions regarding the subjects cardiac and general health.
16264432|NCT00903877|Drug|T3|Patients receive T3 in a dose of 25mcg and 50mcg
16264433|NCT00903851|Drug|Lidoderm|Patients participated in an 8-week treatment period; patients at one site were to continue treatment for the entire 8 weeks while patients at two sites were to terminate treatment after 3 weeks. Commercially available Lidoderm® (lidocaine patch 5%) was provided to each patient with up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain.
16264434|NCT00903838|Drug|pardoprunox|1.5 to 12 mg/day
16264435|NCT00903838|Drug|pramipexole|0.75-4.5 mg/day
16264436|NCT00903825|Procedure|Ultrasound guided injection of femoral local anesthetic (lidocaine)|Injection of lidocaine (< 10 mls of lidocaine, 1%w/v) before femoral artery puncture with free-hand duplex ultrasound guidance.
16264437|NCT00903825|Procedure|Injection of femoral local anesthetic (lidocaine) with manual palpation|Injection of lidocaine before femoral artery catheterization with manual palpation.
16264438|NCT00903812|Other|No intervention|No intervention as observational study
16264439|NCT00903799|Device|Implantation of ENTERRA therapy|Gastric electrical stimulation using Enterra Therapy
16264440|NCT00903786|Drug|perampanel|Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
16264441|NCT00903773|Drug|telaprevir|
16264442|NCT00903760|Drug|Decitabine|Decitabine 20 mg/m^2 by vein daily over 1-2 hours for 5 days for both Group 1 and Group 2. Group 1 receives decitabine on Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21; and Group 2 is on Days 1-5 of every cycle.
16264443|NCT00903760|Drug|Clofarabine|Clofarabine 10 mg/m^2 by vein daily over 1-2 hours for 5 days on Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24.
16264444|NCT00903747|Drug|prucalopride|2-10 mg prucalopride
16264445|NCT00903747|Drug|moxifloxacin|400 mg moxifloxacin (Group 2a)
16264446|NCT00903747|Drug|placebo|placebo (Group 2b)
16264447|NCT00903734|Drug|Erlotinib Hydrochloride (Tarceva)|Dose of 150 mg daily by mouth.
16264448|NCT00903721|Drug|mometasone furoate|"Metered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg)
~Duration: up to 6 months"
16264449|NCT00903708|Drug|LY2275796|100 mg administered by vein as a loading dose daily over 3 days, and then as a maintenance dose weekly thereafter.
16264727|NCT00901979|Drug|Placebo|
16264450|NCT00903695|Drug|Memory XL|An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, & acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months
16264451|NCT00903695|Drug|placebo|placebo comparator
16264452|NCT00903682|Drug|etravirine (ETR, TMC125)|400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
16264453|NCT00903682|Drug|efavirenz (EFV)|600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
16264454|NCT00903656|Drug|doxorubicinhydrochloride, Lapatinib|Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles
16264455|NCT00903643|Other|Physical examination|Physical examination and multiple questionnaires will be administered
16264456|NCT00903630|Drug|Lenalidomide|administered by mouth at the assigned dose daily for each 28 day cycle
16264457|NCT00903630|Drug|liposomal doxorubicin|administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle
16264458|NCT00903617|Drug|GSK256073|5 mg for 8 weeks
16264459|NCT00903617|Drug|GSK256073|50 mg for 8 weeks
16264460|NCT00903617|Drug|GSK256073|150 mg for 8 weeks
16264461|NCT00903617|Drug|Placebo|placebo for 8 weeks
16264462|NCT00903617|Drug|Niaspan|1500 mg for 8 weeks
16264463|NCT00903617|Drug|GSK256073|x mg for 8 weeks based from data from Part A
16264464|NCT00903617|Drug|GSK256073|optional dose based on data from Part A
16264465|NCT00903604|Drug|AP214|Three 10-minutes infusions of sequential ascending dosages of AP214
16264466|NCT00903604|Drug|Placebo|Three 10-minutes infusions of isotonic saline solution
16264467|NCT00903591|Other|questionaire, blood or saliva sample|Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them.
16264468|NCT00903552|Biological|Influenza VLP Vaccine|
16264469|NCT00903552|Biological|Placebo|phosphate-buffered saline (PBS)
16264470|NCT00903539|Device|SecurAcath Securement System|Subcutaneous catheter securement system
16264471|NCT00903500|Behavioral|Daily physical activity, pedometer and counseling|Individual counseling session, telephone counseling (7 calls), given by a psychologist and a pedometer, based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing
16264472|NCT00903500|Behavioral|Usual care|Usual care
16264473|NCT00903474|Other|questionnaire administration|
16264474|NCT00903474|Other|study of socioeconomic and demographic variables|
16264475|NCT00903474|Procedure|CAM exercise therapy|
16264476|NCT00903474|Procedure|psychosocial assessment and care|
16264477|NCT00903474|Procedure|quality-of-life assessment|
16264478|NCT00903474|Procedure|stress management therapy|
16264479|NCT00903461|Biological|EGFR Antisense DNA|"Intratumoral EGFR AS injections weekly x 7 weeks (or less if there is no identifiable tumor), starting 2 weeks prior to radiation. The first EGFR AS injection must be given after cetuximab is administered. Subsequent EGFR AS injections can be given before or after cetuximab is administered. Injections will be in the primary and/or lymph nodes. One site will be injected per weekly session. If it is necessary the antisense injection can be scheduled within 1 business day of the original schedule date and then resume the original schedule
~EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined. The same lesion (primary tumor or lymph node) will be injected during treatment."
16264480|NCT00903448|Drug|Prilosec OTC (omeprazole-magnesium)|Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast
16264481|NCT00903448|Drug|Prevacid|Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast
16264482|NCT00903435|Other|Quantitative Sensory Testing and Stimulus|No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.
16264483|NCT00903422|Drug|eltrombopag olamine|thrombopoietin receptor agonist
16264484|NCT00903422|Other|Placebo|Placebo tablets with no active pharmaceutical ingredient
16264485|NCT00903409|Drug|Simvastatin + Lovaza® (omega-3-acid ethyl esters)|Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]
16264486|NCT00903396|Drug|palonosetron hydrochloride|Given IV
16264487|NCT00903396|Other|placebo|Given IV
16264488|NCT00903383|Drug|LX3305 low dose|A low dose of LX3305; daily oral intake for 12 weeks
16264489|NCT00903383|Drug|LX3305 mid dose|A mid dose of LX3305; daily oral intake for 12 weeks
16264490|NCT00903383|Drug|LX3305 high dose|A high dose of LX3305; daily oral intake for 12 weeks
16264491|NCT00903383|Drug|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
16264492|NCT00903370|Procedure|MVS|All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed.
16264534|NCT00903162|Drug|zoledronic acid|If desired, given intravenously every 6 months for a total of 4 injections (optional)
16264535|NCT00903136|Other|questionnaire administration|
16264536|NCT00903136|Procedure|comparison of screening methods|
16264537|NCT00903136|Procedure|diagnostic endoscopic procedure|
16264538|NCT00903136|Procedure|esophagogastroduodenoscopy|
16264539|NCT00903136|Procedure|tethered capsule endoscopy|
16264635|NCT00902512|Other|Blood samples for the analysis of sildenafil in plasma|Blood samples for the analysis of sildenafil in plasma
16264493|NCT00903370|Device|Ablation|For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins. For participants treated with biatrial maze lesion set, the left atrial lesions will include, the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture is noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture is noted, additional ablations on the atrial cuff will be performed until isolation is confirmed. This will be repeated on the left pulmonary veins.
16264494|NCT00903357|Drug|Montelukast first, then placebo|"Patients in Montelukast first, then placebo will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in Placebo first, then Montelukast are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks."
16264495|NCT00903357|Drug|Placebo first, then Montelukast|"Patients in Montelukast first, then placebo will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in Placebo first, then Montelukast are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks."
16264496|NCT00903344|Drug|Vitamin D3|4000IU vitamin D3 tablet taken daily
16264497|NCT00903344|Dietary Supplement|Multivitamin|Multivitamin containing 400IU vitamin D in tablet taken daily
16264498|NCT00903331|Drug|ACT-064992 (macitentan)|ACT-064992 (macitentan) tablet, 10 mg, once daily
16264499|NCT00903331|Drug|Placebo|matching placebo, once daily
16264500|NCT00903318|Behavioral|Questionnaire|Questionnaire about family's characteristics taking about 30-35 minutes to complete.
16264501|NCT00903305|Other|medical chart review|
16264502|NCT00903305|Other|questionnaire administration|
16264503|NCT00903305|Procedure|fatigue assessment and management|
16264504|NCT00903305|Procedure|psychosocial assessment and care|
16264505|NCT00903305|Procedure|quality-of-life assessment|
16264506|NCT00903292|Drug|erlotinib (Tarceva)|chemotherapy with erlotinib
16264507|NCT00903292|Drug|pemetrexed (Alimta)|Chemotherapy with pemetrexed
16264508|NCT00903279|Drug|Placebo|Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
16264509|NCT00903279|Drug|Altabax (retapamulin)|Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
16264510|NCT00903266|Behavioral|Melodic Intonation Therapy|MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
16264511|NCT00903266|Behavioral|Speech-Repetition-Therapy|Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
16264512|NCT00903253|Drug|LNK-754|
16264513|NCT00903227|Drug|Fluticasone Evohaler pMDI|One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
16264514|NCT00903227|Drug|Placebo|1 puff of inhaled Placebo twice a day
16264515|NCT00903227|Drug|Fluticasone Evohaler|One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)
16264516|NCT00903227|Drug|Placebo intranasal spray|placebo intranasal spray 2 squirts each nostril once a day
16264517|NCT00903227|Drug|fluticasone propionate (Flixonase®)|intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts
16264518|NCT00903214|Drug|riluzole|100 mg orally twice a day, tablets self-administered, administered from day -14 to day 0 (scheduled surgery and preserve tissue for biormarker analysis)
16264519|NCT00903214|Genetic|polymorphism analysis|Pre-treatment, day -15 but may be done any time after enrollment but before surgery.
16264520|NCT00903214|Procedure|axillary lymph node biopsy|
16264521|NCT00903214|Procedure|digital image analysis|
16264522|NCT00903214|Procedure|needle biopsy|
16264523|NCT00903214|Procedure|sentinel lymph node biopsy|
16264524|NCT00903214|Procedure|therapeutic conventional surgery|
16264525|NCT00903201|Drug|SB656933|20 mg
16264526|NCT00903201|Drug|SB656933|50mg
16264527|NCT00903201|Drug|Placebo|placebo
16264528|NCT00903188|Drug|cyclosporine|"Cyclosporine (Group 1):
~basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4
~Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.
~C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml
~Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.
~Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.
~Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop"
16264529|NCT00903188|Drug|Everolimus|"Everolimus (Group 2):
~Basiliximab dose: idem as in group 1
~Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.
~Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.
~Enteric-coated mycophenolate (MPA) dosing idem as group 1.
~Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.
~Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60."
16264530|NCT00903175|Drug|everolimus|Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
16264531|NCT00903175|Drug|sunitinib|Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.
16264532|NCT00903162|Drug|leuprolide|Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
16264540|NCT00903110|Drug|Increlex®|Increlex® (mecasermin [rDNA origin] injection), 10 mg/ml solution for injection, 20-120mcg/kg BID or 0,02 to 0,12 mg/kg BID, as prescribed by physician
16264541|NCT00903084|Drug|Tenofovir Disoproxil Fumarate|300-mg tablet
16264542|NCT00903071|Behavioral|Real PPL|See above arm description
16264543|NCT00903071|Behavioral|Sim PPL|See above arm description
16264544|NCT00903045|Drug|Propiverine hydrochloride|Propiverine hydrochloride 20mg twice a day
16264545|NCT00903045|Drug|Placebo|Identical placebo twice a day
16264546|NCT00903032|Behavioral|Intervention|The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
16264547|NCT00903032|Behavioral|Usual care|Usual care following ACS hospital discharge.
16264548|NCT00903019|Behavioral|Tele-Problem-Solving Therapy|Six sessions of tele-PST
16264549|NCT00903019|Behavioral|In-Person PST|Six sessions of in person PST
16264550|NCT00903019|Behavioral|Attention control|Six weekly telephone calls
16264551|NCT00903006|Drug|Fulvestrant|Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.
16264552|NCT00903006|Drug|MK-0646|Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.
16264553|NCT00903006|Drug|Dasatinib|Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily.
16264554|NCT00902993|Drug|AZD1446|Solution, oral single and multiple dose
16264555|NCT00902993|Drug|Placebo|Placebo
16264556|NCT00902980|Other|Chart Review|Chart review of patients / graft outcome in renal transplant recipients
16264557|NCT00902967|Drug|Atorvastatin|Atorvastatin 10 mg, once a day dosing at night after meals
16264558|NCT00902967|Drug|Placebo|Placebo tablets of similar shape size and color given once a day at night time after meals
16264559|NCT00902954|Drug|anastrozole|anastrozole 1 mg qd
16264560|NCT00902954|Drug|letrozole|letrozole 2.5 mg qd
16264561|NCT00902954|Drug|exemestane|exemestane 25 mg qd
16264562|NCT00902941|Drug|Azilect 1mg|1 mg daily orally for 120 days
16264563|NCT00902941|Drug|Placebo|1 mg daily orally for 120 days
16264564|NCT00902928|Drug|YM150|oral
16264565|NCT00902928|Drug|enoxaparin|SC injection
16264566|NCT00902915|Drug|lenalidomide plus dexamethasone|peroral application; lenalidomide dosage according to severity grade of renal failure.
16264567|NCT00902889|Procedure|Stimulation|6 weeks stimulation with GPI (lower caudal two contacts), 4 weeks wash-out, 6 weeks stimulation GPE (upper cranial two contacts)
16264568|NCT00902889|Procedure|Stimulation|6 weeks stimulation with GPE (upper cranial two contacts), 4 weeks wash-out, 6 weeks stimulation with GPI (lower caudal two contacts)
16264569|NCT00902876|Device|Mucograft|Collagen Matrix for soft tissue regeneration
16264570|NCT00902876|Procedure|Coronally advanced flap (CAF)|
16264571|NCT00902863|Behavioral|YOGA|Patients with chronic pain will undergo a six week course of YOGA
16264572|NCT00902850|Device|SofLens Daily Disposable|Lenses to be worn for 8-16 hours
16264573|NCT00902850|Device|Marketed 1 Day Contact Lens|Lenses to be worn for 8-16 hours
16264574|NCT00902837|Drug|Oxycodone naloxone prolonged release tablets (OXN)|
16264575|NCT00902837|Drug|oxycodone prolonged release tablet|
16264576|NCT00902837|Drug|oxycodone naloxone tablet|
16264577|NCT00902824|Biological|ADVAX|Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10^7 pfu TBC-M4 (IM)
16264578|NCT00902824|Biological|TBC-M4|Receive 5x10^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.
16264579|NCT00902824|Other|Placebo|"Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector.
~Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM."
16264580|NCT00902811|Drug|AM(FDC)|Artesunate-mefloquine fixed dose combination (artesunate 25mg/mefloquine hydrochloride 55mg, or artesunate 100mg/mefloquine hydrochloride 220mg), according to age-group.
16264581|NCT00902811|Drug|AM(LT)|Artesunate (Arsumax®, Sanofi) 50 mg tabs given at 4 mg/Kg/day on day 0, day 1 and day 2 (total 12 mg/Kg) PLUS Mefloquine 250 mg base tabs given at 25 mg/Kg on day 0. Treatment is given in three equally divided daily doses to the nearest quarter tablet.
16264582|NCT00902811|Drug|AL|Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days, according to weight-groups. The second dose should be taken 6 to 10 hours after the first dose, given at inclusion. Patients will be advised to take some fatty food (or encouraged to give breast feeding) before each dose is taken. Fatty food or milk will not be provided by the researchers.
16264583|NCT00902811|Drug|DP|40 mg dihydroartemisinin/320 mg piperaquine tablets and Dihydropiperaquine 20mg/ Piperaquine 160 mg tablets),. Treatment is given according to age groups. In the age group <6yrs of age, a subdivision according to weight is made
16264584|NCT00902811|Drug|AA(FDC)|Artesunate-amodiaquine fixed dose combination (FDC) (Artesunate Amodiaquine Winthrop® Sanofi Aventis); Artesunate 25mg/amodiaquine 67.5mg; Artesunate 50mg/amodiaquine 135mg ; Artesunate 100mg/amodiaquine 270mg
16264585|NCT00902798|Behavioral|Cognitive Enhancement Therapy|An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.
16264586|NCT00902798|Behavioral|Enriched Supportive Therapy|An 18-month intervention that uses individual supportive therapy to help adults learn about autism spectrum disorder, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies.
16264587|NCT00902785|Other|no drug|observational no drug
16264588|NCT00902772|Drug|Lorazepam|mg, oral dose
16264589|NCT00902772|Drug|AZD7325|mg, oral dose
16264591|NCT00902759|Other|Walking Program|"Brisk walking is defined as faster than the slow walk, but not to exhaustion and not a running pace. Participants will be instructed to walk at home, at a gym or in a shopping mall for as far as possible on a level surface, wearing appropriate footwear as described in the walking booklet. (Patients may continue to walking longer if they desire and are symptom free). Participants should stop or slow down if they experience any discomfort (such as uncomfortable shortness of breath, chest pain, or body pain). The goal is to eventually walk for 90-120 minutes per week in three to four sessions. Participants will not be asked to take their pulse or to record their perceived exertion in order to simplify the program."
16264592|NCT00902746|Drug|NPC-01|"This study consist of the following steps.
~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
16264593|NCT00902733|Other|medical chart review|
16264594|NCT00902733|Other|questionnaire administration|
16264595|NCT00902733|Procedure|fatigue assessment and management|
16264596|NCT00902733|Procedure|psychosocial assessment and care|
16264597|NCT00902733|Procedure|quality-of-life assessment|
16264598|NCT00902720|Other|Tissue sample storage|The tissue sample is frozen and held at -140 degrees at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
16264599|NCT00902707|Drug|Mucinex 1200mg|Compared to Placebo
16264600|NCT00902707|Drug|Placebo|Compare to active Mucinex
16264601|NCT00902694|Behavioral|ACHIEVE Intervention|Group and individual weight loss counseling and group physical activity classes for 18 months
16264602|NCT00902694|Other|Control|group health classes quarterly with topics not related to weight
16264603|NCT00902681|Drug|Fesoterodine|A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
16264604|NCT00902681|Drug|Fesoterodine|A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
16264605|NCT00902668|Drug|lovastatin|
16264606|NCT00902668|Other|questionnaire administration|
16264607|NCT00902668|Procedure|adjuvant therapy|
16264608|NCT00902668|Radiation|accelerated partial breast irradiation|
16264609|NCT00902668|Radiation|external beam radiation therapy|
16264610|NCT00902655|Drug|Desmopressin|Desmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase
16264611|NCT00902642|Behavioral|an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level|an eight day university training course on psychosocial factors for physical therapists
16264612|NCT00902629|Procedure|Early surgery|Intervention group contains patients randomized to receive surgery for their epiretinal fibrosis, at an earlier point than what the common clinical practice is now.
16264613|NCT00902616|Dietary Supplement|L-arginine|3gm TDS for three months
16264614|NCT00902616|Dietary Supplement|Placebo Lactose powder|3gm TDS for 3 months
16264615|NCT00902603|Drug|Commercial Ventavis® (iloprost)|Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)
16264616|NCT00902590|Other|saliva sample and questionaire|"Urothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe the Urothelial Baseline Questionnaire, in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire."
16264617|NCT00902590|Other|saliva sample, questionaire|Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.
16264618|NCT00902577|Drug|FMISO|FMISO PET scans
16264619|NCT00902577|Other|MRI|Undergo MRI
16264620|NCT00902577|Other|PET|Undergo FMISO PET scan
16264621|NCT00902577|Other|MRS|
16264622|NCT00902564|Drug|Escitalopram|Flexible-dosed (5 to 20 mg Oral Tablets Daily)
16264623|NCT00902538|Drug|Olmesartan medoxomil 40 mg - Amlodipine 10 mg|Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily
16264624|NCT00902538|Drug|Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg|Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
16264625|NCT00902538|Drug|Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg|Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day.
16264626|NCT00902538|Drug|OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg|Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
16264627|NCT00902538|Drug|OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg|Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
16264628|NCT00902538|Drug|OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg|Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day.
16264629|NCT00902525|Drug|90Y-Ibritumomab Tiuxetan|All patients receive 2 courses of age-adjusted R-miniDHAP followed by two doses of 90Y-Ibritumomab Tiuxetan
16264630|NCT00902512|Drug|Treatment A|Viagra® 100 mg tablet, administered with water single dose
16264631|NCT00902512|Drug|Blood samples for the analysis of sildenafil in plasma|Blood samples for the analysis of sildenafil in plasma
16264632|NCT00902512|Drug|Treatment B|Sildenafil 100 mg CT administered with water single dose
16264633|NCT00902512|Other|Blood samples for the analysis of sildenafil in plasma|Blood samples for the analysis of sildenafil in plasma
16264634|NCT00902512|Drug|Treatment C|Sildenafil 100 mg CT administered without water single dose
16264636|NCT00902486|Drug|INCB028050|4 mg capsules QD
16264641|NCT00902460|Drug|midazolam; CP-690,550 + midazolam|Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID
16264642|NCT00902460|Drug|CP-690,550 + midazolam; midazolam|Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone
16264643|NCT00902421|Drug|Selective serotonin reuptake inhibitors|escitalopram 10mg once daily for 3 months
16264644|NCT00902421|Drug|Antimuscarinics|Antimuscarinics for 3 months
16264645|NCT00902408|Dietary Supplement|Lutein enriched eggs|1 year of daily enriched lutein eggs or placebo
16264646|NCT00902395|Drug|Midazolam|Oral midazolam 1.0 mg/kg (maximum 20 mg)
16264647|NCT00902395|Behavioral|Protective stabilization|Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
16264648|NCT00902395|Drug|Midazolam, ketamine|Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
16264649|NCT00902369|Drug|AK106-001616|Part1: Dose escalation Part2: Dose expansion
16264650|NCT00902369|Drug|Placebo|
16264651|NCT00902369|Drug|Active comparator|
16264652|NCT00902356|Drug|AMG 167|Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.
16264653|NCT00902356|Drug|Placebo|Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.
16264654|NCT00902343|Procedure|nomogram-based selection for acute normovolemic hemodilution|Will use the nomogram to determine whether or not the patient needs ANH during surgery. The nomogram assigns a point value to certain pre-op factors to determine whether or not the patient will need an ANH. Preoperative factors that will be used are platelet count, planned amount of liver to be removed, hemoglobin level, if the surgeon needs to operate on any organ outside of the liver to remove the tumor, and the patients health overall.
16264655|NCT00902343|Procedure|standard selection for ANH based on a planned resection of 3 or more segments|Will use the planned amount of liver to be removed to determine whether or not the patient needs an ANH during surgery.
16264656|NCT00902330|Procedure|energy-based therapy|Given once a day for 18 weeks
16264657|NCT00902330|Procedure|sham intervention|Given once a day for 18 weeks
16264658|NCT00902317|Procedure|Cryoplasty (PolarCath peripheral balloon catheter)|Cryoplasty involves advancing the balloon catheter to the site of the lesion and delivering liquid nitrous oxide into the balloon, where it expands into gas and inflates the balloon.
16264659|NCT00902317|Procedure|Laser Angioplasty (Spectranetics)|The basic concept of laser angioplasty is to apply light energy directly to the arterial plaque, thereby altering the plaque in some helpful way, without damaging the surrounding artery.
16264660|NCT00902317|Procedure|SilverHawk Atherectomy|Once the catheter is connected to the cutter driver, by retracting the positioning lever this simultaneously turns on the motor and caused the distal portion of the cutter housing to deflect, forcing the device against the target lesion.
16264661|NCT00902317|Device|Viabahn Endograft|The Gore-Viabahn should be positioned across the target lesion using the radiopaque hub and tip markers on the catheter. These markers identify the proximal and distal ends of the device, respectively.
16264662|NCT00902317|Procedure|"Angioplasty/Stent (Guidant Absolute stent)"|A Stent is a metal scaffold that is also delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood flow. The stent remains implanted in the blood vessel, and after a few weeks, the inner lining of the blood vessel will grow over the stent surface.
16264663|NCT00902304|Drug|Valsartan and hydrochlorothiazide (HCTZ) - monotherapy|Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally
16264664|NCT00902304|Drug|Valsartan and amlodipine|From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally
16264665|NCT00902304|Drug|Usual care|As directed by investigator
16264666|NCT00902304|Drug|Valsartan|Valsartan 160mg per day to 320mg per day orally
16264667|NCT00902304|Drug|Valsartan and hydrochlorothiazide (HCTZ) - combination arm|Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally
16264668|NCT00902291|Biological|AGS-1C4D4|IV infusion
16264669|NCT00902291|Biological|Gemcitabine|IV infusion
16264670|NCT00902278|Biological|Flulaval|one 0.5-mL dose via intramuscular injection
16264671|NCT00902278|Biological|Fluvirin|one 0.5-mL dose via intramuscular injection
16264672|NCT00902278|Biological|Fluzone|one 0.5-mL dose via intramuscular injection
16264673|NCT00902278|Biological|Fluarix|one 0.5-mL dose via intramuscular injection
16264674|NCT00902278|Biological|Afluria|one 0.5-mL dose via intramuscular injection
16264675|NCT00902265|Drug|desmopressin|desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
16264676|NCT00902252|Device|Usual|All subjects will wear their usual pouching system for the first 21 days of the study.
16264677|NCT00902252|Device|Natura®|All subjects will wear the Natura® Flexible Skin Barrier with Flange (Stomahesive® or Durahesive®) in the US and Natura® Stomahesive® Flexible Skin Barrier with Flange in Europe for 14 days.
16264678|NCT00902252|Device|Vitala™|"After the successful completion of Stages 1 and 2, subjects will enter the ramp up schedule to allow the subject to adjust to the device. This consists of weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 36 to 42), followed by 6 hours of daily wear time per week (Day 43 to 49), followed by 8 hours of daily wear time (Days 50 to 56) and progressing to 12 hours of daily wear per week (Day 57 to 215)."
16264679|NCT00902226|Drug|Escitalopram|Flexible-dosed (5 to 20 mg Oral Tablets Daily)
16264680|NCT00902213|Behavioral|Physical Therapy|Each patient in this group will have physical therapy performed. The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.
16264728|NCT00901979|Drug|Sitagliptin|
16264681|NCT00902213|Behavioral|Support|Visits with an Advanced Practice Nurse to support sustained motivation.
16264682|NCT00902200|Drug|AR-12286|See arms
16264683|NCT00902200|Drug|AR-12286 vehicle|See arms
16264684|NCT00902187|Drug|Fesoterodine|A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
16264685|NCT00902187|Drug|Fesoterodine|A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
16264686|NCT00902174|Drug|imatinib mesylate|Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.
16264687|NCT00902174|Drug|Placebo|Placebo to imatinib 100 mg film coated tablets
16264688|NCT00902161|Drug|MK0893|Single dose of MK0893 1000 mg (ten 100 mg tablets)
16264689|NCT00902161|Drug|MK0893-matched Placebo|Single dose of placebo to MK0893 (ten tablets)
16264690|NCT00902161|Drug|Propranolol Hydrochloride (HCL)|Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.
16264691|NCT00902148|Device|Polylactic Acid Sheet|SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
16264692|NCT00902135|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder
16264693|NCT00902135|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder
16264694|NCT00902135|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b (Betaferon)
16264695|NCT00902122|Drug|rAd-p53 gene|pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
16264696|NCT00902122|Procedure|surgery|removal of thyroid tumor
16264697|NCT00902122|Drug|p53 gene therapy|p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
16264698|NCT00902122|Radiation|p53 gene therapy with radioactive iodine|p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
16264699|NCT00902109|Device|Perimetry|different perimetric devices, different perimetric grids: Octopus: New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) HFA: 30-2, Sita (Swedish Interactive Thresholding Algorithm) full threshold
16264700|NCT00902109|Device|Confocal Scanning Laser Tomography|HRT examinations for the clinical evaluation of the optic disc.
16264701|NCT00902109|Device|Optical Coherence Tomography (OCT)|imaging of the retinal nerve fiber layer
16264702|NCT00902083|Drug|p53 gene with surgery|pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
16264703|NCT00902083|Procedure|surgery|remove tumor surgery
16264704|NCT00902083|Drug|p53 with chemotherapy|p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy
16264705|NCT00902083|Drug|p53 gene therapy|p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
16264706|NCT00902070|Drug|Rocuronium|Normally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg.
16264707|NCT00902057|Drug|desmopressin|single desmopressin subcutaneous injection, 1.5mcg
16264708|NCT00902057|Drug|desmopressin|single desmopressin subcutaneous injection, 3mcg
16264709|NCT00902057|Drug|desmopressin|single desmopressin subcutaneous injection, 15mcg
16264710|NCT00902057|Drug|placebo|saline subcutaneous
16264711|NCT00902044|Genetic|Autologous HER2-specific T cells|Each patient will receive one intravenous injection of autologous HER2-specific T cells at one of the dose levels. If the patient has stable disease or a reduction in the size of the tumor they can receive additional doses of HER2-specific T cells at 6 to 12 weeks intervals-each of which will consist of the same cell number as their HER2-specific T-cell injection. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.
16264712|NCT00902044|Drug|Fludarabine|"Fludarabine will be administered for 5 days prior to the T cells
~The dose:
~>10 kg: 25 mg/m2/day;
~<10 kg: 1 mg/kg/day IV over 30 minutes"
16264713|NCT00902044|Drug|Cyclophosphamide|"Cyclophosphamide will be administered for 2 days.
~Fludarabine and cyclophosphamide will be given for 2 days, followed by fludarabine alone for the next 3 days, followed by 2 days of rest, before the T cells will be administered.
~Cyclophosphamide Dose:
~30 mg/kg/day IV over 1 hour (with Mesna and IV hydration)
~Fludarabine Dose:
~>10 kg: 25 mg/m2/day; <10 kg: 1 mg/kg/day IV over 30 minutes"
16264714|NCT00902044|Genetic|Autologous CAR Positive T cells|Patient will receive one intravenous injection of autologous CAR T cells at dose level 9C. Further CAR T-cell dose escalation at dose level 9C will be done using the lymphodepletion schema as in dose level 9B.
16264715|NCT00902031|Drug|Docusate Sodium, Sennoside|"Docusate sodium: given in capsule form (100 mg/capsule), at a dosage of 200 mg, taken twice daily for 10 days.
~Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days."
16264716|NCT00902031|Drug|Sennoside + Placebo|"Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.
~Placebo: will be taken in capsule form, similar in size, shape, and color to docusate, taken twice daily for 10 days"
16264717|NCT00902018|Drug|Eltrombopag|The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times, weekly, for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.
16264718|NCT00902018|Drug|Romiplostim|three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times
16264719|NCT00902018|Other|healthy controls|single blood draw for all measures included in the intervention arms
16264720|NCT00901992|Behavioral|MEDIAS 2 ICT|MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants)
16264721|NCT00901992|Behavioral|Current ICT program (ACC-ICT)|This program is conducted in 10 lessons in a group setting (4-8 participants)
16264722|NCT00901979|Drug|LCQ908A|
16264723|NCT00901979|Drug|LCQ908A|
16264724|NCT00901979|Drug|LCQ908A|
16264730|NCT00901940|Biological|Meningococcal (Groups A, C, Y and W-135) Conjugate|2 x 0.5 mL dose
16264731|NCT00901940|Biological|Meningococcal polysaccharide A, C, Y and W135 and Menveo|1 x 0.5 mL dose of ACWY Vax, 1 x 0.5 mL dose of Menveo
16264732|NCT00901927|Drug|Bendamustine|Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
16264733|NCT00901927|Drug|Mitoxantrone|10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.
16264734|NCT00901927|Drug|Rituximab|375 mg/m^2 by vein over several hours on Day 1 of each cycle.
16264735|NCT00901914|Biological|Placebo|One sublingual tablet of matching placebo daily during approximately 5.5 months
16264736|NCT00901914|Biological|rBet v 1|One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
16264737|NCT00901914|Biological|rBet v 1|One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
16264738|NCT00901914|Biological|rBet v 1|One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
16264739|NCT00901901|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg twice daily
16264740|NCT00901901|Drug|Erlotinib (Tarceva)|Erlotinib 150 mg once daily
16264741|NCT00901901|Drug|Placebo|Matching erlotinib placebo 150 mg once daily
16264742|NCT00901888|Drug|Apelin infusion|Infusion of up to 10picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.
16264743|NCT00901888|Drug|Sodium nitroprusside infusion|Infusion of up to 150-600picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.
16264744|NCT00901875|Drug|Buprenorphine + naloxone (Suboxone)|Sublingual tablets
16264745|NCT00901875|Drug|Buprenorphine + naloxone (Suboxone)|
16264746|NCT00901862|Device|Pulsed magnetic fields (Quantum MH-2MR bracelet)|Pulsed magnetic fields
16264747|NCT00901862|Device|Sham pulsed magnetic fields (Quantum MH-2MR bracelet)|Hybrid circuits crucial for the generation of the electromagnetic field had been removed.
16264748|NCT00901849|Drug|Tarceva and Rapamycin|Tarceva will be administered once a day for 28 days without interruption. THen Rapamycin will be administered, orally twice daily, in combination with the Tarceva for the remainder of the study.
16264749|NCT00901836|Radiation|Preoperative proton therapy|28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.
16264750|NCT00901836|Procedure|Surgery|Standard of care surgery will be performed 4-6 weeks after completion of radiation.
16264751|NCT00901823|Drug|Diazoxide choline|A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
16264752|NCT00901823|Drug|Diazoxide choline high dose|A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR
16264753|NCT00901810|Device|Electronic Apex Locator|Electronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file.
16264754|NCT00901810|Device|Dental Radiography|Radiography is used to measure the length of root canal by putting an endodontic file in the canal and taking the radiography to measure the length.
16264755|NCT00901797|Procedure|Arthroscopic Bankart repair|Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.
16264756|NCT00901797|Procedure|ABR+ARIC|Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Through additional anterior superior portal a suture is passed inferior and adjacent to the SSP and through the superior portion of the Sub Scapularis tendon while the arm in 30 degree of external rotation. Tightening the suture on top of the capsule underneath the deltoid. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.
16264757|NCT00901784|Drug|Topiramate|25mg Tablets
16264758|NCT00901771|Device|Provent|This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
16264759|NCT00901758|Drug|IV Nitroglycerin|IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL.
16264760|NCT00901758|Drug|Normal saline|IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL
16264761|NCT00901745|Drug|Angiotensin II|Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
16264762|NCT00901745|Drug|Noradrenaline infusion|Infusion of up to 480 picomol/ml of noradrenaline will be infused.
16264763|NCT00901732|Device|Caphosol|Oral Mouth Rinse
16264764|NCT00901719|Drug|Apelin|Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial apelin infusions at 0.3, 1.0 and 3.0 nanomol/ml.
16264765|NCT00901719|Drug|Acetylcholine|Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min
16264766|NCT00901719|Drug|Sodium nitroprusside|Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min
16264767|NCT00901719|Drug|Systemic apelin infusion|Following plethysmography patients will receive systemic infusion of (Pry)Apelin-13 (30, 100 and 300 nmol/min) for 5 mins cardiac output, blood pressure, heart rate and systemic vascular resistance will be measured at 5-min intervals.
16264768|NCT00901706|Other|Comprehensive Geriatric Assessment and APS Usual Care|Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.
16264769|NCT00901706|Other|APS usual care|APS usual care consists of social, medical, and legal assistance.
16264770|NCT00901693|Drug|AL-46383A Ophthalmic Solution|
16264771|NCT00901693|Drug|AL-46383A Ophthalmic Solution Vehicle|
16264772|NCT00901654|Biological|ACE527 vaccine|"First cohort: Two doses, each of 3x10^9 cfu of each strain (9x10^9 cfu total per dose) administered on Days 0 and Day 21 (out-patient).
~Second cohort: Two doses, each of 3x10^10 cfu of each strain (9x10^10 cfu total per dose) administered on Days 0 and Day 21"
16264773|NCT00901654|Biological|Placebo vaccine|First and second cohort: The placebo vaccine will be administered at Days 0 and Days 21.
16264774|NCT00901641|Device|CogniFit Personal Coach®|The program provides individually tailored cognitive training based on the results of a baseline evaluation (the Neuropsychological Examination - CogniFit Personal Coach®).7 The program assigns scores to 17 cognitive abilities that are subsequently trained by means of 21 different tasks.
16264775|NCT00901628|Drug|ropivacaine|300mg (0.75%, 40cc) intraoperative periarticular injection
16264776|NCT00901628|Drug|morphine sulfate|10mg intraoperative periarticular injection
16264777|NCT00901628|Drug|ketorolac|30 mg intraoperative periarticular injection
16264778|NCT00901628|Drug|epinephrine|300 microgram (1:1000) intraoperative periarticular injection
16264779|NCT00901628|Drug|cefuroxime|750mg intraoperative periarticular injection
16264780|NCT00901615|Drug|Lenalidomide and R-CHOP|Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
16264781|NCT00901589|Dietary Supplement|marine n-3 polyunsaturated fatty acids|Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total
16264782|NCT00901589|Dietary Supplement|thistle oil|four capsules a day
16264783|NCT00901589|Dietary Supplement|marine n-3 polyunsaturated fatty acids|Four capsules daily, 2.2 g marine n-3 PUFAs in total
16264784|NCT00901589|Dietary Supplement|Thistle oil|Four capsules daily
16264785|NCT00901576|Drug|SPD503|SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
16264786|NCT00901576|Drug|Concerta|CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
16264787|NCT00901576|Drug|SPD503 + Concerta|SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).
16264788|NCT00901563|Drug|Rotigaptide|Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, rotigaptide will be infused for 30mins. During the ischaemic period no drug will be infused but the infusion will be restarted once the blood pressure cuff has been deflated and blood flow returns to the limb.
16264789|NCT00901563|Other|Forearm vascular study|Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min) or Acetylcholine (5, 10 , 20 micromol/min) . Venous blood sampling via cannula in antecubital fossa.
16264790|NCT00901550|Drug|Methotrexate|All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5 mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8
16264791|NCT00901550|Drug|Infliximab|Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter.
16264792|NCT00901537|Drug|Azacitidine and Cisplatin|We plan to give azacitidine daily as subcutaneous injection at escalated doses (37, 60, 75, 85, 100 and 110 mg/m2) for 5 days from day 1 to day 5, and give cisplatin 75 mg/m2 as intravenous injection on day 8, every 4 weeks as a cycle.
16264793|NCT00901524|Drug|Peg-interféron alpha 2a + ribavirin|Pilot study, multicenter, open label
16264794|NCT00901511|Drug|GM-CSF [Leukine (Sargramostim)]|"Acute treatment: the PAP subjects will receive inhaled rGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg/24 hours. The acute treatment will be accomplished in 12 weeks, for 7 consecutive days every second week (thus, 6 weeks on and 6 weeks off). For those PAP patients receiving the GM-CSF for the first time (1st and 2nd level treated groups), the treatment will be performed by 1 week run-in, after discharge from the ICU, in the Respiratory Disease Department (during this period PAP patients usually receive e.v. corticosteroids, and oral antibiotics). After the run-in period, the patient is discharged and inhalation treatment will continue at home.
~Maintenance treatment: 17 weeks after the WLL (4 weeks after the completion of the acute treatment), the PAP patient will start the maintenance treatment. He/she will receive inhaled GM-CSF at the dose of 250 mcg/daily for 2 consecutive days every 14 days (2 days on and 12 days off) for a period of 6 month"
16264795|NCT00901511|Procedure|WLL|Whole lung lavage
16264796|NCT00901498|Drug|BMS-708163|Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.
16264797|NCT00901498|Drug|BMS-708163|Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings
16264798|NCT00901498|Drug|BMS-708163|Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings
16264799|NCT00901498|Drug|BMS-708163|Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings
16264800|NCT00901498|Drug|BMS-708163|Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
16264801|NCT00901485|Device|AutoVPAP|Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.
16264802|NCT00901485|Device|VPAPIIIST-A|Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.
16264803|NCT00901459|Device|Active rTMS Condition|Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
16264804|NCT00901459|Device|rTMS Location Control Condition|Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.
16264805|NCT00901459|Device|rTMS Frequency Control Condition|High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
16264806|NCT00901446|Device|Intravascular ultrasound and spectroscopy|Intracoronary imaging with a catheter based ultrasound transducer and near infrared spectroscopy tip that is pulled back at an automated rate of 0.5 millimeters per second.
16264807|NCT00901433|Device|Personal WheezoMeter|pulmonary sounds analyzer
16264878|NCT00900783|Drug|valacyclovir|1 gram, three times a day for seven days
16264808|NCT00901420|Procedure|Urodynamics Test|90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
16264809|NCT00901420|Behavioral|Questionnaire|Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.
16264810|NCT00901407|Drug|lamotrigine|lamotrigine augmentation 25 to 100 mg tablets, 25 to 200 mg bid,10 weeks
16264811|NCT00901407|Drug|placebo|placebo: 1-2 tablets bid; 10 weeks
16264812|NCT00901407|Drug|paroxetine|open label paroxetine 10 to 50 mg, at bedtime for 18 weeks (8 weeks prior to randomization and 10 weeks after)
16264813|NCT00901394|Drug|B12-Folic Acid, nitrous oxide|"IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.
~IV folic acid, 5 mg, single administration over 30 min.
~Both diluted in 250 ml normal saline."
16264814|NCT00901394|Drug|Nitrous oxide (NO) and placebo|60% nitrous oxide anesthesia plus saline
16264815|NCT00901394|Other|Placebo|Saline
16264816|NCT00901394|Other|oxygen nitrogen|60% air and oxygen mix.
16264817|NCT00901381|Drug|Filgrastim|10 µg/kg subcutaneously once daily x 5 days
16264818|NCT00901368|Drug|FOSTER|CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)
16264819|NCT00901368|Drug|Seretide|Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)
16264820|NCT00901342|Biological|sipuleucel-T|Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
16264821|NCT00901329|Device|NexGen Gender Fixed Bearing Knee prosthesis|new female prosthesis
16264822|NCT00901329|Device|NexGen LPS-Flex Fixed Bearing Knee prosthesis|standard knee prosthesis
16264823|NCT00901316|Procedure|Routine Measures Group|"Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Please see supplemental material from the publication Randomized Trial of Bleach Baths plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding routine measures."
16264824|NCT00901316|Procedure|Bleach Bath Group (Bleach plus routine measures)|"Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths. Please see supplemental material from the publication Randomized Trial of Bleach Baths plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding instructions for bleach baths."
16264825|NCT00901303|Drug|ABVD chemotherapy|Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle
16264826|NCT00901290|Drug|monophasic oral contraceptive|mg, oral dose
16264827|NCT00901290|Drug|AZD7325|mg, oral dose
16264828|NCT00901277|Behavioral|web intervention|A multi-behavioral, comprehensive approach is proposed addressing up to 13 health behaviors focused on improving subject management of CVD and related health behaviors. This is a web-based intervention.
16264829|NCT00901277|Behavioral|nurse intervention|A multi-behavioral, comprehensive approach is proposed addressing up to 13 health behaviors focused on improving subject management of CVD and related health behaviors given by the nurse via phone.
16264830|NCT00901238|Procedure|Intra-arterial Chemotherapy|selective catheterization of the ophthalmic artery and injection of melphalan and topotecan
16264831|NCT00901225|Drug|G-CSF plus Plerixafor|"On Day 5 of G-CSF mobilization,
~if the patient's peripheral CD34+ cell count is < 7cells/µl then 240ug/kg Plerixafor will be given in the evening prior to receiving 10µg/kg G-CSF and undergoing apheresis the next morning for up to 3 days of apheresis or until ≥ 5x10(6) cells/kg are collected.
~if the patient's peripheral CD34+ cell count is 7 to 19 cells/ul (inclusive), apheresis will be done. If the apheresis yield is < 1.3x10(6) CD34+ cells/kg then 240ug/kg Plerixafor will be given in the evening prior to receiving 10 µg/kg G-CSF and undergoing apheresis the next morning. If the apheresis yield is at least double that on Day 5, Plerixafor followed the next morning by G-CSF and apheresis will be repeated for up to a total of 3 days of apheresis or until 5x10(6) cells/kg are collected."
16264832|NCT00901212|Device|Device programming|6-month period
16264833|NCT00901199|Drug|Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)|All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.
16264834|NCT00901186|Drug|RFB002|0.5 mg
16264835|NCT00901186|Procedure|Laser photocoagulation|
16264836|NCT00901160|Procedure|blood test|Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.
16264837|NCT00901147|Drug|panobinostat and bortezomib|oral panobinostat 30 mg 3 times per week AND intravenous bortezomib 1.3mg/m2 on days 1,4,8,11 per cycle
16264838|NCT00901121|Device|Straumann BoneCeramic|Straumann BoneCeramic (500-1000 microns, 0.5g)
16264839|NCT00901121|Device|Bio-Oss|Bio-Oss spongiosa granules, size of particle 0.25-1 mm
16264840|NCT00901108|Procedure|Trabectome-IOL|"Trabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways.
~Trabectome will be done first, followed by cataract surgery because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery."
16264879|NCT00900783|Drug|FV-100|400 mg, once daily, for seven days
16264880|NCT00900783|Drug|FV-100|200 mg, once daily, for seven days
16264841|NCT00901108|Procedure|Trab-IOL|"Trabeculectomy bypasses the normal aqueous outflow channels of the eye and creates an external filtration pathway (called a filtering bleb) for aqueous to drain and be reabsorbed back into the circulation. Mitomycin C is an agent used during this procedure to decrease scar formation around the new passage.
~Cataract surgery will be done first, followed by Trabeculectomy with Mitomycin C."
16264842|NCT00901095|Behavioral|Lifestyle intervention|Participants will attend a 15 weekly class sessions during the first 4 months. Classes will be co-lead by a dietician and exercise specialist and will involve a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by action-planning and goal-setting. During the next 2 months, participants will meet with a dietician on an individual basis for a private weigh-in, personal discussion and problem solving, review of self-monitoring records, and action-planning. The last 6 months will consist of applying and maintaining what has been learned in previous class sessions. Self-monitoring records, questions and problems will be discussed with interventions at least once every 2 months or more frequently if needed.
16264843|NCT00901082|Behavioral|Relaxation and information session|Relaxation and information session before the medial branch block
16264844|NCT00901069|Drug|Azacitidine with rituximab, vincristine, and cyclophosphamide|Azacitidine cycle days 1-5 Cyclophosphamide cycle days 6-9 Vincristine cycle day 8 Rituximab cycle day 8 Rituximab is only for those patients with CD20+ lymphoma. Azacitidine 25 mg/m2^ Azacitidine 50 mg/m2^ Azacitidine 75 mg/m2^ Azacitidine 100 mg/m2^
16264845|NCT00901056|Device|Extracorporeal Shockwave Therapy|Energy Density - 0.02 - 0.15 mJ/mm2
16264846|NCT00901043|Dietary Supplement|Walnut supplementation|Eight weeks of walnut supplementation
16264847|NCT00901043|Dietary Supplement|Ad lib diet|Eight weeks without walnut supplementation
16264848|NCT00901030|Procedure|Blood drawn|Blood samples will be taken once in the preoperative clinic and once again at the end of the surgery in the post anesthetic care unit to do the TEG and PMA tests.
16264849|NCT00901017|Device|Straumann BoneCeramic|Bone augmentation procedure performed with Bone Ceramic
16264850|NCT00901017|Device|Bio-Oss|Bone Augmentation procedure performed with Bio Oss
16264851|NCT00900991|Biological|split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)|
16264852|NCT00900978|Biological|7 valent pneumococcal conjugate vaccine (7v-PCV) - Prevenar|The 7v-PCV will be given to children below 2 years of age. Nasopharyngeal swabs will be taken from the children before vaccination and after finishing the vaccination. The vaccine will be given in a 2+1 scheme.
16264853|NCT00900965|Device|Electroacupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))|A specially designed copper needle (0.22 x 4 mm), which can be used safely in MRI suite, will be inserted through a plaster over the respective acupoints, under which a plastic ring will be positioned, connected with electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair) through wires with stimulation frequency of 150 Hz, lasting for 30 minutes.
16264854|NCT00900965|Device|Sham acupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))|Needle will be positioned at 2 cm away from the true respective acupoints, with a blunted, telescopic placebo needle. The same electric stimulation will be the same as real acupuncture treatment.
16264855|NCT00900952|Other|Clinical record review|
16264856|NCT00900939|Behavioral|Low-fat, vegan diet|Participants in the intervention group will be asked to follow a low-fat, vegan diet for the full 16 weeks of the study. They will also be guided to favor foods with a low glycemic index. The diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products, added oils, and added sugars will be excluded.
16264857|NCT00900939|Behavioral|Control|Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.
16264858|NCT00900913|Drug|ropivacaine (Naropin)|intravenous infusion 1 mg/kg bw
16264859|NCT00900900|Dietary Supplement|dehydroepiandrosterone (DHEA)|one-time 400mg oral dose of DHEA
16264860|NCT00900900|Dietary Supplement|pregnenolone|one-time 400mg oral dose of pregnenolone
16264861|NCT00900900|Drug|Placebo|one-time dose oral dose
16264862|NCT00900887|Drug|Ketorolac|ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
16264863|NCT00900887|Drug|Nepafenac|topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
16264864|NCT00900887|Drug|Polietilenglicol 400, propilenglicol|"ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml
~dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week"
16264865|NCT00900874|Drug|salbutamol|two puffs (100 microgram each of salbutamol) by MDI and spacer
16264866|NCT00900874|Drug|Formoterol|Formoterol 2 puffs (6 µg /puff) by MDI and spacer
16264867|NCT00900835|Other|educational intervention|
16264868|NCT00900835|Other|questionnaire administration|
16264869|NCT00900835|Other|study of socioeconomic and demographic variables|
16264870|NCT00900835|Procedure|assessment of therapy complications|
16264871|NCT00900835|Procedure|fatigue assessment and management|
16264872|NCT00900835|Procedure|quality-of-life assessment|
16264873|NCT00900835|Procedure|standard follow-up care|
16264874|NCT00900822|Device|Straumann Bone Ceramic|Granules applied once during surgery
16264875|NCT00900822|Device|BioOss|Granules that are applied once during surgery
16264876|NCT00900809|Biological|Neukoplast™ (NK-92)|The Neukoplast™ (NK-92) cells will be administered intravenously over 60 minutes. The starting dose of Neukoplast™ (NK-92) cells will be 1 x 10e9 ZRx-101 cells/m2 (The 3 dose levels are: 1 x 10e9 cells/m2, 3 x 10e9 cells/m2 and 5 x 10e9 cells/m2). The second infusion will only be administered after 24 hours if no unacceptable or dose limiting toxicities side effects due to the infusion of Neukoplast™ were encountered after the first infusion.
16264877|NCT00900796|Other|Treatment switching|If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria
16265001|NCT00900172|Biological|bevacizumab|
16264881|NCT00900783|Drug|Valacyclovir placebo|three times a day, for seven days
16264882|NCT00900783|Drug|FV-100 placebo|once daily, for seven days
16264883|NCT00900757|Drug|Palonosetron (PALO)|Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
16264884|NCT00900744|Drug|Tamoxifen|20 mg daily
16264885|NCT00900731|Drug|Indacaterol 150 μg|Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16264886|NCT00900731|Drug|Tiotropium 18 μg|Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
16264887|NCT00900731|Drug|Placebo to indacaterol|Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16264888|NCT00900731|Drug|Placebo to tiotropium|Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
16264889|NCT00900718|Device|Straumann Bone Ceramic|Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
16264890|NCT00900718|Device|Bio-Oss|Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.
16264891|NCT00900692|Device|Dynasplint|"Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen"
16264892|NCT00900679|Behavioral|telephone-based intervention|
16264893|NCT00900679|Other|counseling intervention|
16264894|NCT00900679|Other|educational intervention|
16264895|NCT00900679|Other|medical chart review|
16264896|NCT00900679|Other|questionnaire administration|
16264897|NCT00900679|Procedure|psychosocial assessment and care|
16264898|NCT00900679|Procedure|quality-of-life assessment|
16264899|NCT00900666|Drug|placebo|A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
16264900|NCT00900666|Drug|botulinum toxin A (BTX-A)|200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
16264901|NCT00900653|Drug|Gynoflor E (low dose estriol with lactobacillus)|The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days
16264902|NCT00900640|Procedure|ERCP as medically indicated by subjects referring physician|Determine the incidence of adverse reactions to CM administered during ERCP in patients with prior reaction to IV CM administration and/or shellfish allergy.
16264903|NCT00900627|Drug|AZD8931|Tablet Oral bid
16264904|NCT00900627|Drug|Paclitaxel|IV once weekly for 3 weeks followed by a week off (repeated cycles)
16264905|NCT00900627|Drug|Placebo|Oral bid (twice daily)
16264906|NCT00900614|Drug|APR-246|Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
16264907|NCT00900601|Procedure|Arthrodesis to the sacroiliac joint and symphysis|"Standard surgical procedures will be used. When the patient has isolated pain in the symphysis isolated fixation will be performed. A 2x2 cm large bone block will be removed and replaced with spongy bone. For fixation the Matta-plate will be applied.
~To the sacroiliac joint we use an anterior approach. A 2x1,5 cm large bone block will be removed and replaced with spongy bone from the iliac crest. For joint fixation we either use 2 plates or sacroiliac screws. The same procedure will be used on the other side in the cases with bilateral symptoms. Only one side will be operated at a time. After one year it will be decided if it's necessary to perform contralateral surgery."
16264908|NCT00900588|Biological|split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)|
16264909|NCT00900575|Device|Optical Spectroscopy Bench-Top System|This device is a bench-top optical spectrometer
16264910|NCT00900575|Device|Portable Optical Spectrometer|This device is a portable optical spectrometer
16264911|NCT00900575|Device|Transvaginal colposcope|
16264913|NCT00900549|Device|CRT on|12 months
16264914|NCT00900549|Device|CRT off|12-month
16264915|NCT00900536|Genetic|mutation analysis|
16264916|NCT00900536|Genetic|polymorphism analysis|
16264917|NCT00900536|Genetic|protein expression analysis|
16264918|NCT00900536|Other|immunohistochemistry staining method|
16264919|NCT00900536|Other|laboratory biomarker analysis|
16264920|NCT00900523|Genetic|protein expression analysis|protein expression analysis
16264921|NCT00900523|Other|immunohistochemistry|immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels
16264922|NCT00900510|Procedure|Incision and drainage|
16264923|NCT00900510|Drug|Trimethoprim/Sulfamethoxazole (Bactrim)|Trimethoprim/Sulfamethoxazole, oral
16264924|NCT00900510|Drug|Placebo|
16264925|NCT00900497|Biological|White Blood Cells/Granulocytes|Granulocytes collected by apheresis, cross-matched for ABO-Rh and common antibodies, HLA-mismatched to avoid engraftment
16264926|NCT00900484|Other|biologic sample preservation procedure|
16264927|NCT00900484|Other|immunohistochemistry staining method|
16264928|NCT00900484|Other|laboratory biomarker analysis|
16264929|NCT00900471|Other|biologic sample preservation procedure|
16264930|NCT00900471|Other|medical chart review|
16264931|NCT00900458|Behavioral|Aerobic Exercise training|aerobic exercise training (cycling)
16264932|NCT00900445|Drug|Daunorubicin Hydrochloride|Given IV
16264933|NCT00900445|Other|Pharmacological Study|Correlative studies
16264934|NCT00900445|Drug|Prednisolone|Given orally
16264935|NCT00900445|Drug|Prednisone|Given orally
16264936|NCT00900445|Drug|Vincristine Sulfate|Given IV
16264937|NCT00900432|Other|immunoenzyme technique|
16264938|NCT00900432|Other|laboratory biomarker analysis|
16264939|NCT00900419|Other|immunohistochemistry staining method|Laboratory test
16264940|NCT00900419|Other|laboratory biomarker analysis|Laboratory Test
16264941|NCT00900419|Other|sputum cytology|Laboratory Test
16264942|NCT00900419|Procedure|biopsy|Laboratory Test
16264943|NCT00900406|Genetic|gene expression analysis|blood collection
16264944|NCT00900406|Genetic|microarray analysis|Blood collection
16264945|NCT00900406|Genetic|polymorphism analysis|Blood collection
16264946|NCT00900406|Genetic|proteomic profiling|Blood collection
16264947|NCT00900406|Other|flow cytometry|Blood collection
16264948|NCT00900406|Other|immunologic technique|Blood collection
16264949|NCT00900406|Other|laboratory biomarker analysis|Blood collection
16264950|NCT00900406|Procedure|biopsy|Blood collection
16264951|NCT00900380|Other|flow cytometry|
16264952|NCT00900380|Other|immunological diagnostic method|
16264953|NCT00900380|Other|laboratory biomarker analysis|
16264954|NCT00900367|Other|high performance liquid chromatography|
16264955|NCT00900367|Other|laboratory biomarker analysis|
16264956|NCT00900367|Procedure|spectroscopy|
16264957|NCT00900354|Genetic|molecular genetic technique|
16264958|NCT00900354|Other|mass spectrometry|
16264959|NCT00900354|Other|pharmacological study|
16264960|NCT00900341|Genetic|DNA analysis|
16264961|NCT00900341|Genetic|gene expression analysis|
16264962|NCT00900341|Genetic|protein expression analysis|
16264963|NCT00900341|Genetic|reverse transcriptase-polymerase chain reaction|
16264964|NCT00900341|Genetic|western blotting|
16264965|NCT00900341|Other|immunohistochemistry staining method|
16264966|NCT00900341|Other|laboratory biomarker analysis|
16264967|NCT00900328|Other|laboratory biomarker analysis|Correlative Studies
16264968|NCT00900302|Genetic|protein expression analysis|The first ten cases will be reviewed to assess the spectrum of OX-40 expression and to devise a semiquantitative scoring system. Each slide will be scanned in its entirety and then scored according to representative views with the greatest expression of immunostaining. Two independent viewers, who will be blinded to clinical data and outcome at the time of scoring, will review all slides. Scores from these independent readings will be compared, and differences were resolved upon mutual review of given cases. We will estimate the distribution of OX-40 IHC score by tumor type and tumor stage. OX-40 IHC score will be correlated with the IHC scores of other markers using Spearman's correlation coefficient. Kruskal-Wallis test will be used to test whether OX-40 IHC score is comparable between tumor type and tumor stage
16264969|NCT00900302|Other|immunohistochemistry staining method|5-micron sections will be cut, mounted on capillary gap slides and dried in a 60°C oven. The slides will then be then deparaffinized in xylene baths and gradually hydrated in graded alcohol. For epitope retrieval, the slides are placed in baths of 0.5 M Tris buffer at pH 10 and subjected to microwave irradiation for at least 19 minutes. The slides will be cooled and washed with deionized water and 0.05% TWEEN. They are then placed in a blocking solution of 0.3% bovine serum albumin, drained, and placed in wells of their primary antibody in a humidity chamber at room temperature overnight. Primary mouse antihuman antibodies will include anti-OX-40, anti-CD4, and anti-HLA class II. Anti-rat CD45 will be used as a negative control for each section. The slides will then be then washed and placed in their appropriate biotinylated anti-mouse secondary antibody for 24 minutes. Endogenous peroxidase in the samples is blocked using a solution of 3% hydrogen peroxide.
16264970|NCT00900302|Other|laboratory biomarker analysis|Lymphocytes will be collected from fresh tissue and peripheral blood (PBLs) for use in marker analysis and in vitro assays of immune function. Tissues will be dissociated to obtain lymphocytes
16264971|NCT00900302|Procedure|biopsy|De-identified tissue samples will be obtained from the OHSU Pathology Department. Tissues will consist of paraffin blocks collected either prospectively for previous cases, or fresh tissue collected prospectively for patients enrolled in the study. For either case, tissue will be collected only after tissue necessary for the adequate rendering of the pathologic diagnosis has been collected by the pathology Department. Thus, the collection of tissue will not compromise patient diagnosis/care.
16264972|NCT00900289|Genetic|DNA methylation analysis|
16264973|NCT00900289|Genetic|microarray analysis|
16264974|NCT00900289|Genetic|polymerase chain reaction|
16264975|NCT00900289|Other|immunohistochemistry staining method|
16264976|NCT00900289|Other|laboratory biomarker analysis|
16264977|NCT00900276|Other|immunologic technique|
16264978|NCT00900276|Other|laboratory biomarker analysis|
16264979|NCT00900276|Other|mass spectrometry|
16264980|NCT00900263|Genetic|cytogenetic analysis|
16264981|NCT00900263|Genetic|microarray analysis|
16264982|NCT00900263|Other|biologic sample preservation procedure|
16264983|NCT00900263|Other|laboratory biomarker analysis|
16264984|NCT00900250|Other|Cytology Specimen Collection Procedure|Correlative studies
16264985|NCT00900237|Drug|Eslicarbazepine acetate|Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
16264986|NCT00900237|Drug|Oxcarbazepine|Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)
16264987|NCT00900224|Genetic|DNA analysis|
16264988|NCT00900224|Genetic|DNA methylation analysis|
16264989|NCT00900224|Genetic|gene expression analysis|
16264990|NCT00900224|Genetic|mutation analysis|
16264991|NCT00900224|Genetic|polymerase chain reaction|
16264992|NCT00900224|Genetic|reverse transcriptase-polymerase chain reaction|
16264993|NCT00900224|Other|high performance liquid chromatography|
16264994|NCT00900224|Other|laboratory biomarker analysis|
16264995|NCT00900211|Genetic|microarray analysis|
16264996|NCT00900211|Genetic|molecular diagnostic method|
16264997|NCT00900211|Other|biologic sample preservation procedure|
16264998|NCT00900185|Genetic|mutation analysis|
16264999|NCT00900185|Genetic|polymerase chain reaction|
16265000|NCT00900185|Genetic|polymorphism analysis|
16265004|NCT00900172|Genetic|gene expression analysis|
16265005|NCT00900172|Genetic|polymerase chain reaction|
16265006|NCT00900172|Genetic|polymorphism analysis|
16265007|NCT00900172|Other|laboratory biomarker analysis|
16265008|NCT00900159|Drug|eszopiclone|3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
16265009|NCT00900159|Drug|matching placebo|matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
16265010|NCT00900146|Drug|Canakinumab|Canakinumab lyophilized cake (25 mg and 150 mg in individual 6 mL glass vials ) was reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections.
16265011|NCT00900146|Drug|Metformin|Before randomization, in drug naïve patients at a dose of 1000 mg with the evening meal or 500 mg b.i.d. (twice daily) with two main meals. At the randomization visit, patients were prescribed with no less than 1,000mg/day.
16265012|NCT00900146|Drug|Placebo|Placebo lyophilized cake will be reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections.
16265013|NCT00900133|Other|immunoenzyme technique|Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.
16265014|NCT00900133|Other|laboratory biomarker analysis|Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.
16265015|NCT00900107|Procedure|Exercise|
16265016|NCT00900094|Genetic|fluorescence in situ hybridization|
16265017|NCT00900094|Genetic|polymerase chain reaction|
16265018|NCT00900094|Genetic|protein expression analysis|
16265019|NCT00900094|Other|immunohistochemistry staining method|
16265020|NCT00900094|Other|laboratory biomarker analysis|
16265021|NCT00900094|Other|mass spectrometry|
16265022|NCT00900081|Other|immunohistochemistry staining method|
16265023|NCT00900081|Other|laboratory biomarker analysis|
16265024|NCT00900081|Other|medical chart review|
16265025|NCT00900068|Other|immunoenzyme technique|
16265026|NCT00900068|Other|laboratory biomarker analysis|
16265027|NCT00900068|Other|medical chart review|
16265028|NCT00900055|Genetic|microarray analysis|
16265029|NCT00900055|Genetic|polyacrylamide gel electrophoresis|
16265030|NCT00900055|Genetic|polymerase chain reaction|
16265031|NCT00900055|Genetic|protein expression analysis|
16265032|NCT00900055|Genetic|reverse transcriptase-polymerase chain reaction|
16265033|NCT00900055|Genetic|western blotting|
16265034|NCT00900055|Other|chromatography|
16265035|NCT00900055|Other|high performance liquid chromatography|
16265036|NCT00900055|Other|immunoenzyme technique|
16265037|NCT00900042|Genetic|DNA ploidy analysis|
16265038|NCT00900042|Genetic|DNA stability analysis|
16265039|NCT00900042|Genetic|chromosomal translocation analysis|
16265040|NCT00900042|Genetic|cytogenetic analysis|
16265041|NCT00900042|Other|flow cytometry|
16265042|NCT00900042|Other|laboratory biomarker analysis|
16265043|NCT00900029|Biological|No HP802 Treatment|
16265044|NCT00900029|Other|No HP802 Vehicle Treatment|
16265045|NCT00900016|Genetic|protein expression analysis|
16265046|NCT00900016|Genetic|western blotting|
16265047|NCT00900016|Other|immunohistochemistry staining method|
16265048|NCT00900016|Other|immunologic technique|
16265049|NCT00900016|Other|laboratory biomarker analysis|
16265050|NCT00900003|Genetic|protein analysis|Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), we will determine if pre-treatment markers can be used to correlate with clinical outcomes of survival and recurrence. Examples of such markers include studying if the integrity of DNA repair pathway in pancreatic cancers, analyzed by Rad51 and phosphorylated DNA-PK foci formation, correlates with tumor response to radiotherapy, chemotherapy, and overall survival. The markers targeted are proteins secreted by cancer cells and/or cancer associated cells.
16265051|NCT00900003|Other|laboratory biomarker analysis|A method of extracting and identifying secreted cytokines and growth factors from tissues of the quantity of typical biopsy tissues has been developed.The purpose of this study is to determine if this method of biomarker discovery can now be applied to pancreatic cancer population.
16265052|NCT00899990|Other|Laboratory Biomarker Analysis|Correlative studies
16265053|NCT00899977|Drug|Placebo|Matching placebo
16265054|NCT00899977|Drug|TC-5214|
16265055|NCT00899964|Behavioral|Physical activity|6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules
16265056|NCT00899951|Drug|fentanyl citrate|
16265057|NCT00899951|Other|pharmacological study|
16265058|NCT00899912|Genetic|microarray analysis|
16265059|NCT00899912|Other|diagnostic laboratory biomarker analysis|
16265060|NCT00899899|Genetic|microarray analysis|
16265061|NCT00899899|Genetic|reverse transcriptase-polymerase chain reaction|
16265062|NCT00899899|Other|laboratory biomarker analysis|
16265063|NCT00899873|Genetic|cytogenetic analysis|
16265064|NCT00899873|Other|flow cytometry|
16265065|NCT00899873|Other|fluorescence activated cell sorting|
16265066|NCT00899873|Other|immunoenzyme technique|
16265067|NCT00899873|Other|laboratory biomarker analysis|
16265068|NCT00899847|Procedure|Autologous peripheral blood stem cells (auto-PBSC) transplantation|"Auto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy.
~and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective"
16265069|NCT00899847|Procedure|Allogeneic peripheral blood stem cells (allo-PBSC) transplantation|Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.
16265137|NCT00899600|Other|Normal saline|Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
16265138|NCT00899587|Drug|enalapril|enalapril 5 mg every night
16265199|NCT00899262|Other|immunohistochemistry staining method|
16265070|NCT00899847|Drug|Filgrastim|"Filgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis.
~Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery.
~Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection."
16265071|NCT00899847|Drug|Cyclophosphamide|Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.
16265072|NCT00899847|Drug|Melphalan|Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.
16265073|NCT00899847|Drug|Cyclosporine|Cyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted.
16265074|NCT00899847|Radiation|Total lymphoid irradiation|Total lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion.
16265075|NCT00899847|Biological|Rabbit anti-thymocyte globulin|ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.
16265076|NCT00899847|Drug|Mycophenolate Mofetil 250mg|MMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression
16265077|NCT00899847|Drug|Solumedrol|Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion
16265078|NCT00899847|Drug|Diphenhydramine|Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.
16265079|NCT00899847|Drug|Acetaminophen|Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.
16265080|NCT00899847|Drug|Hydrocortisone|Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.
16265081|NCT00899821|Biological|aldesleukin|
16265082|NCT00899821|Biological|recombinant interleukin-12|
16265083|NCT00899821|Biological|sargramostim|
16265084|NCT00899821|Other|immunologic technique|
16265085|NCT00899821|Procedure|biopsy|
16265086|NCT00899795|Genetic|cytogenetic analysis|
16265087|NCT00899795|Genetic|fluorescence in situ hybridization|
16265088|NCT00899795|Other|flow cytometry|
16265089|NCT00899795|Procedure|biopsy|
16265090|NCT00899782|Other|cytology specimen collection procedure|correlative studies
16265091|NCT00899769|Genetic|protein expression analysis|
16265092|NCT00899769|Genetic|proteomic profiling|
16265093|NCT00899769|Other|immunoenzyme technique|
16265094|NCT00899769|Other|laboratory biomarker analysis|
16265095|NCT00899769|Other|liquid chromatography|
16265096|NCT00899769|Other|mass spectrometry|
16265097|NCT00899756|Genetic|molecular diagnostic method|
16265098|NCT00899756|Genetic|mutation analysis|
16265099|NCT00899743|Genetic|polyacrylamide gel electrophoresis|polyacrylamide gel electrophoresis
16265100|NCT00899743|Genetic|western blotting|western blotting
16265101|NCT00899743|Other|immunologic technique|immunologic technique
16265102|NCT00899743|Other|laboratory biomarker analysis|laboratory biomarker analysis
16265103|NCT00899717|Procedure|Occlusal adjustment|modification of occlusal surfaces
16265104|NCT00899717|Procedure|Placebo occlusal adjustment|Simulated modification of occlusal surfaces
16265105|NCT00899704|Genetic|microarray analysis|
16265106|NCT00899704|Genetic|allele-specific oligonucleotide real-time quantitative polymerase chain reaction|
16265107|NCT00899704|Other|diagnostic laboratory biomarker analysis|
16265108|NCT00899691|Genetic|protein expression analysis|
16265109|NCT00899678|Drug|Certolizumab Pegol|"400 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
~*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
16265110|NCT00899678|Drug|Certolizumab Pegol|"200 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
~*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
16265111|NCT00899665|Genetic|fluorescence in situ hybridization|
16265112|NCT00899665|Genetic|microarray analysis|
16265113|NCT00899665|Genetic|molecular diagnostic method|
16265114|NCT00899665|Other|immunohistochemistry staining method|
16265115|NCT00899665|Other|laboratory biomarker analysis|
16265116|NCT00899665|Procedure|biopsy|
16265117|NCT00899665|Procedure|immunoscintigraphy|
16265118|NCT00899652|Genetic|Southern blotting|
16265119|NCT00899652|Genetic|chromosomal translocation analysis|
16265120|NCT00899652|Genetic|cytogenetic analysis|
16265121|NCT00899652|Genetic|gene rearrangement analysis|
16265122|NCT00899652|Genetic|mutation analysis|
16265123|NCT00899626|Genetic|protein analysis|
16265124|NCT00899626|Genetic|proteomic profiling|
16265125|NCT00899626|Other|biologic sample preservation procedure|
16265126|NCT00899626|Other|laboratory biomarker analysis|
16265127|NCT00899626|Other|medical chart review|
16265128|NCT00899626|Procedure|diagnostic colonoscopy|
16265129|NCT00899626|Procedure|diagnostic endoscopic procedure|
16265130|NCT00899626|Procedure|diagnostic endoscopic surgery|
16265131|NCT00899626|Procedure|diagnostic surgical procedure|
16265132|NCT00899626|Procedure|endoscopic surgery|
16265133|NCT00899626|Procedure|screening colonoscopy|
16265134|NCT00899613|Other|laboratory biomarker analysis|
16265135|NCT00899613|Procedure|study of high risk factors|
16265136|NCT00899600|Drug|Ketamine|Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure
16265139|NCT00899587|Other|oxygen|oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month
16265140|NCT00899587|Drug|placebo|
16265141|NCT00899574|Drug|Imiquimod|"Each treatment cycle consists of 8 weeks.
~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
16265142|NCT00899548|Genetic|DNA methylation analysis|laboratory analysis
16265143|NCT00899548|Genetic|microarray analysis|laboratory analysis
16265144|NCT00899548|Genetic|polymerase chain reaction|laboratory analysis
16265145|NCT00899548|Other|laboratory biomarker analysis|laboratory analysis
16265146|NCT00899535|Genetic|DNA analysis|
16265147|NCT00899535|Genetic|RNA analysis|
16265148|NCT00899535|Genetic|microarray analysis|
16265149|NCT00899535|Genetic|mutation analysis|
16265150|NCT00899535|Genetic|polymorphism analysis|
16265151|NCT00899522|Other|biologic sample preservation procedure|Once the pathologist has taken the material needed to establish diagnosis of cancer, the anonymized snap-frozen and fresh samples will be either shipped to our laboratory for analysis or will be picked up by a member of the principal investigator's lab team. Samples will be stored indefinitely.
16265152|NCT00899522|Procedure|biopsy|Once the pathologist has taken the material needed to establish diagnosis of cancer, 1-10 grams of the remaining tissue should be placed in phosphate buffered saline and shipped to the Bagby Lab.
16265153|NCT00899509|Other|laboratory biomarker analysis|correlative studies
16265154|NCT00899496|Other|immunological diagnostic method|
16265155|NCT00899496|Other|physiologic testing|
16265156|NCT00899483|Drug|Glucose potassium insulin solution|Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution
16265157|NCT00899470|Drug|Co-administration of Saxagliptin and Metformin IR, Fasted|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
16265158|NCT00899470|Drug|Saxagliptin/Metformin, Fasting|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
16265159|NCT00899470|Drug|Co-administration of Saxagliptin and Metformin IR, Fed|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
16265160|NCT00899470|Drug|Saxagliptin/Metformin, Fed|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
16265161|NCT00899457|Genetic|proteomic profiling|Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
16265162|NCT00899457|Other|biologic sample preservation procedure|Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
16265163|NCT00899457|Other|laboratory biomarker analysis|Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
16265164|NCT00899457|Procedure|bronchoscopy|Collection of breath condensate.
16265165|NCT00899431|Drug|Lenalidomide|Starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months
16265166|NCT00899431|Drug|Fludarabine|30 mg/m^2 intravenously daily on days -5, -4, -3.
16265167|NCT00899431|Drug|Rituximab|375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8.
16265168|NCT00899431|Drug|Thymoglobulin|1.0 mg/kg intravenously over 4 hours (day -2 and -1).
16265169|NCT00899431|Procedure|Stem Cell Transplantation|On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
16265170|NCT00899431|Drug|Bendamustine|130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
16265171|NCT00899431|Drug|Allopurinol|300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.
16265172|NCT00899418|Genetic|gene expression analysis|
16265173|NCT00899418|Genetic|polymerase chain reaction|
16265174|NCT00899418|Genetic|polymorphism analysis|
16265175|NCT00899418|Other|immunohistochemistry staining method|
16265176|NCT00899392|Other|Emmi Pediatric Upper Endoscopy Patient Education Module|Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC
16265177|NCT00899379|Drug|rizatriptan benzoate|Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
16265178|NCT00899379|Drug|Comparator: Placebo|Placebo to Rizatriptan, Oral Tablet
16265179|NCT00899366|Genetic|microarray analysis|
16265180|NCT00899366|Genetic|mutation analysis|
16265181|NCT00899366|Other|immunologic technique|
16265182|NCT00899353|Dietary Supplement|Omega 3 Fatty Acid|Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.
16265183|NCT00899340|Genetic|gene expression analysis|profiles of HPV(+) and (-) HNSCCs
16265184|NCT00899340|Genetic|microarray analysis|microarray analysis
16265185|NCT00899340|Genetic|protein expression analysis|protein expression analysis
16265186|NCT00899340|Other|immunohistochemistry staining method|immunohistochemistry staining method
16265187|NCT00899340|Other|laboratory biomarker analysis|laboratory biomarker analysis
16265188|NCT00899327|Genetic|DNA methylation analysis|
16265189|NCT00899327|Genetic|RNA analysis|
16265190|NCT00899327|Genetic|cytogenetic analysis|
16265191|NCT00899327|Genetic|gene expression analysis|
16265192|NCT00899327|Genetic|mutation analysis|
16265193|NCT00899327|Genetic|polymerase chain reaction|
16265194|NCT00899327|Genetic|protein expression analysis|
16265195|NCT00899327|Other|laboratory biomarker analysis|
16265196|NCT00899301|Other|biologic sample preservation procedure|Tissue, urine and blood collection.
16265197|NCT00899288|Procedure|spectroscopy|Nails will be chemically characterized using Raman spectroscopy.
16265198|NCT00899275|Other|Cytology Specimen Collection Procedure|Correlative studies
16265200|NCT00899262|Other|laboratory biomarker analysis|
16265201|NCT00899262|Other|sputum cytology|
16265202|NCT00899262|Procedure|Fourier transform infrared spectroscopy|
16265203|NCT00899262|Procedure|diagnostic bronchoscopy|
16265204|NCT00899223|Other|biologic sample preservation procedure|
16265205|NCT00899210|Other|laboratory biomarker analysis|
16265206|NCT00899210|Procedure|cryosurgery|
16265207|NCT00899210|Procedure|radiofrequency ablation|
16265208|NCT00899210|Procedure|therapeutic conventional surgery|
16265209|NCT00899197|Drug|tamoxifen citrate|
16265210|NCT00899197|Genetic|gene expression analysis|
16265211|NCT00899197|Genetic|protein expression analysis|
16265212|NCT00899197|Other|immunoenzyme technique|
16265213|NCT00899197|Other|laboratory biomarker analysis|
16265214|NCT00899184|Genetic|polymorphism analysis|
16265215|NCT00899184|Other|laboratory biomarker analysis|
16265216|NCT00899171|Genetic|DNA analysis|
16265217|NCT00899171|Genetic|DNA methylation analysis|
16265218|NCT00899171|Genetic|RNA analysis|
16265219|NCT00899171|Genetic|gene expression analysis|
16265220|NCT00899171|Genetic|reverse transcriptase-polymerase chain reaction|
16265221|NCT00899171|Other|laboratory biomarker analysis|
16265222|NCT00899158|Other|immunologic technique|
16265223|NCT00899158|Other|laboratory biomarker analysis|
16265224|NCT00899158|Procedure|biopsy|
16265225|NCT00899145|Other|Laboratory Biomarker Analysis|Correlative studies
16265226|NCT00899132|Genetic|in situ hybridization|Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.
16265227|NCT00899132|Genetic|protein expression analysis|Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.
16265228|NCT00899132|Other|immunologic technique|Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.
16265229|NCT00899119|Procedure|leukapheresis|
16265230|NCT00899093|Other|Cytology Specimen Collection Procedure|Correlative studies
16265231|NCT00899093|Other|Laboratory Biomarker Analysis|Correlative studies
16265232|NCT00899080|Genetic|gene expression analysis|
16265233|NCT00899080|Genetic|reverse transcriptase-polymerase chain reaction|
16265234|NCT00899080|Other|immunoenzyme technique|
16265235|NCT00899080|Other|laboratory biomarker analysis|
16265236|NCT00899080|Other|platelet aggregation test|
16265237|NCT00899054|Drug|P276-00|P276-00 will be administered at different dose levels: level 1: 100 mg/m2/day dose level 2: 140 mg/m2/day dose level 3: 185 mg/m2/day to be given from day 1 to day 5 every 21 days for 2 cycle. P276-00 will be administered as intravenous infusion in 200 ml 5% Dextrose over 30 min from days 1 to 5 per 21 day cycle for two cycles.
16265238|NCT00899054|Radiation|External beam radiotherapy (EBRT)|All subjects will receive external beam radiotherapy (EBRT)by using standard conventional fractionation i.e. 2 Gy per day for 5 days a week for a total radiation dose of 60 Gy over 6 weeks followed by upto 10 additional Gy if required.
16265239|NCT00899041|Procedure|Total Knee Arthroplasty (TKA)|28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
16265240|NCT00899028|Genetic|comparative genomic hybridization|
16265241|NCT00899028|Genetic|fluorescence in situ hybridization|
16265242|NCT00899028|Genetic|gene expression analysis|
16265243|NCT00899028|Genetic|microarray analysis|
16265244|NCT00899028|Genetic|protein expression analysis|
16265245|NCT00899028|Other|immunohistochemistry staining method|
16265246|NCT00899028|Other|laboratory biomarker analysis|
16265247|NCT00899028|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16265248|NCT00899028|Other|medical chart review|
16265249|NCT00899028|Procedure|diagnostic bronchoscopy|
16265250|NCT00899015|Other|pharmacological study|
16265251|NCT00899002|Genetic|comparative genomic hybridization|
16265252|NCT00899002|Genetic|molecular genetic technique|
16265253|NCT00899002|Genetic|mutation analysis|
16265254|NCT00899002|Genetic|polymerase chain reaction|Not noted
16265255|NCT00899002|Genetic|proteomic profiling|
16265256|NCT00899002|Other|immunohistochemistry staining method|not noted
16265257|NCT00899002|Other|laboratory biomarker analysis|not noted
16265258|NCT00899002|Other|mass spectrometry|not noted
16265259|NCT00899002|Other|medical chart review|not noted
16265260|NCT00898976|Other|immunohistochemistry staining method|
16265261|NCT00898976|Other|laboratory biomarker analysis|
16265262|NCT00898963|Genetic|gene expression analysis|
16265263|NCT00898963|Genetic|microarray analysis|
16265264|NCT00898963|Genetic|polymorphism analysis|
16265265|NCT00898963|Other|diagnostic laboratory biomarker analysis|
16265266|NCT00898963|Other|immunohistochemistry staining method|
16265267|NCT00898963|Other|immunologic technique|
16265268|NCT00898950|Drug|Aspirin|Aspirin 75mgs/day orally for 2 weeks.
16265269|NCT00898950|Drug|Aspirin|300mgs/day orally for 2 weeks
16265270|NCT00898950|Drug|Aspirin|aspirin 900mgs QID orally for 2 weeks
16265271|NCT00898950|Other|placebo tablet|placebo tablet with lactose and excipients.
16265272|NCT00898937|Genetic|microarray analysis|tumor specimen will be assessed by microarray analysis
16265273|NCT00898937|Procedure|breast biopsy|A breast biopsy will be done to obtain a tumor specimen
16265274|NCT00898924|Genetic|molecular diagnostic method|
16265275|NCT00898924|Genetic|mutation analysis|
16265276|NCT00898911|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16265277|NCT00898898|Other|diagnostic laboratory biomarker analysis|Correlative studies
16265278|NCT00898885|Procedure|oral biopsy|oral mucosa and salivary gland biopsy after bone marrow transplantation
16265279|NCT00898872|Other|cryopreservation|
16265280|NCT00898846|Drug|UFT adjuvant chemotherapy|UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
16265281|NCT00898833|Other|laboratory biomarker analysis|
16265282|NCT00898820|Genetic|gene expression analysis|
16265283|NCT00898820|Genetic|polymorphism analysis|
16265284|NCT00898820|Genetic|protein expression analysis|
16265285|NCT00898807|Drug|citalopram|target dose 30mg daily for 9 weeks
16265286|NCT00898807|Drug|placebo|daily for 9 weeks
16265287|NCT00898794|Biological|bevacizumab|
16265288|NCT00898794|Other|coagulation study|
16265289|NCT00898794|Other|laboratory biomarker analysis|
16265290|NCT00898794|Other|platelet aggregation test|
16265291|NCT00898768|Procedure|Capsule endoscopy|Capsule endoscopy at baseline and after 2 years
16265292|NCT00898755|Other|Cytology Specimen Collection Procedure|Correlative studies
16265293|NCT00898755|Other|Laboratory Biomarker Analysis|Correlative studies
16265294|NCT00898742|Genetic|DNA and tissue microarray analysis|The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
16265295|NCT00898742|Genetic|reverse transcriptase-polymerase chain reaction|The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
16265296|NCT00898742|Other|mass spectrometry|The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
16265297|NCT00898716|Drug|BMS-754807|Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response
16265298|NCT00898703|Other|flow cytometry|
16265299|NCT00898703|Other|immunoenzyme technique|
16265300|NCT00898703|Other|laboratory biomarker analysis|
16265301|NCT00898690|Genetic|cytogenetic analysis|
16265302|NCT00898690|Genetic|gene expression analysis|
16265303|NCT00898690|Genetic|microarray analysis|
16265304|NCT00898690|Genetic|mutation analysis|
16265305|NCT00898690|Genetic|reverse transcriptase-polymerase chain reaction|
16265306|NCT00898690|Other|immunohistochemistry staining method|
16265307|NCT00898677|Drug|rizatriptan benzoate|single dose administration of 5mg rizatriptan (by Mouth) p.o.
16265308|NCT00898677|Drug|rizatriptan benzoate|single dose administration of 10 mg rizatriptan p.o.
16265309|NCT00898677|Drug|Comparator: sumatriptan|single dose administration of sumatriptan 100 p.o.
16265310|NCT00898677|Drug|Comparator: Placebo|placebo to rizatriptan
16265311|NCT00898664|Genetic|cytogenetic analysis|
16265312|NCT00898664|Genetic|gene expression analysis|
16265313|NCT00898664|Genetic|mutation analysis|
16265314|NCT00898664|Genetic|polymerase chain reaction|
16265315|NCT00898664|Other|immunohistochemistry staining method|
16265316|NCT00898664|Other|laboratory biomarker analysis|
16265317|NCT00898638|Other|biologic sample preservation procedure|
16265318|NCT00898638|Other|medical chart review|
16265319|NCT00898599|Dietary Supplement|Prebiotic|Inulin type fructooligosaccharides
16265320|NCT00898599|Dietary Supplement|Placebo|Maltodextrin as placebo
16265321|NCT00898573|Drug|lapatinib ditosylate|
16265322|NCT00898573|Genetic|fluorescence in situ hybridization|
16265323|NCT00898573|Genetic|gene expression analysis|
16265324|NCT00898573|Genetic|mutation analysis|
16265325|NCT00898573|Genetic|polymerase chain reaction|
16265326|NCT00898573|Genetic|reverse transcriptase-polymerase chain reaction|
16265327|NCT00898573|Other|cell sorting|
16265328|NCT00898573|Other|immunohistochemistry staining method|
16265329|NCT00898573|Other|laboratory biomarker analysis|
16265330|NCT00898560|Drug|eslicarbazepine acetate and Microginon®|"eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
~Microginon®: single oral dose on day 14 of treatment period"
16265331|NCT00898560|Drug|Microginon®|Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
16265332|NCT00898547|Other|immunoenzyme technique|
16265333|NCT00898547|Other|laboratory biomarker analysis|
16265334|NCT00898534|Device|Bayer DCA2000+ Hemoglobin A1c analyzer|Point-of-care hemoglobin A1c measurement of blood obtained by fingerstick
16265335|NCT00898521|Drug|DGD|"DGD is a mixture of lyophilized enzymes derived from purified Bromelain from pineapple stem.
~Two grams or 5 grams of Debrase powder are dissolved in 20 grams or 50 grams of Gel Vehicle to obtain DGD. DGD is applied to the burn wound at a dose of 2g Debrase/20g Gel per 100 cm2 of skin or 5g Debrase/50g Gel per 250 cm2 for a duration of four hours. In an average human adult, 100 cm2 represents approximately 1% of Total Body Surface Area (TBSA).
~Please note that for individuals of exceptional size (e.g. children), it is important to calculate the dosage based on the 100 cm2 measurement.
~The Debrase powder and the Gel Vehicle are to be mixed at the patient bedside for a maximum of 15 min prior to use.
~DGD should not be applied to more than 15% TBSA in one session. If the wound area to be treated is more than 15% TBSA, DGD should be applied in two or more separate sessions.
~DGD should not be applied more than twice to the same burn wound area."
16265336|NCT00898508|Genetic|gene expression analysis|
16265337|NCT00898508|Genetic|mutation analysis|
16265338|NCT00898508|Genetic|proteomic profiling|
16265339|NCT00898508|Genetic|reverse transcriptase-polymerase chain reaction|
16265340|NCT00898508|Other|fluorescent antibody technique|
16265341|NCT00898508|Other|immunohistochemistry staining method|
16265342|NCT00898508|Other|laboratory biomarker analysis|
16265343|NCT00898508|Other|liquid chromatography|
16265344|NCT00898508|Other|mass spectrometry|
16265345|NCT00898508|Other|medical chart review|
16265346|NCT00898508|Procedure|quality-of-life assessment|
16265347|NCT00898495|Genetic|loss of heterozygosity analysis|
16265348|NCT00898495|Genetic|polymerase chain reaction|
16265349|NCT00898495|Genetic|polymorphism analysis|
16265350|NCT00898482|Other|This is a non-intervention study for all groups.|This is a non-intervention study.
16265351|NCT00898482|Other|study of socioeconomic and demographic variables|Non-intervention study.
16265352|NCT00898469|Genetic|polymorphism analysis|
16265353|NCT00898456|Genetic|gene expression analysis|
16265354|NCT00898456|Genetic|molecular genetic technique|
16265355|NCT00898456|Genetic|polymorphism analysis|
16265356|NCT00898456|Genetic|protein expression analysis|
16265357|NCT00898456|Other|diagnostic laboratory biomarker analysis|
16265358|NCT00898443|Other|Epidural anesthetic|Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation
16265359|NCT00898443|Other|Spinal anesthetic|This group was assigned to receive spinal anesthetic for postpartum tubal ligation.
16265360|NCT00898430|Genetic|DNA Microarray analysis|Tumors will be assayed on Affymetrix Human Genome U133 GeneChip
16265361|NCT00898430|Genetic|MALDI-TOF mass spectrometry|Supervised analysis techniques will be employed to identify patterns of protein peaks useful for treatment response and survival prediction. Hierarchical clustering analyses will be used to visualize data.
16265362|NCT00898430|Genetic|DNA microarray and MALDI-TOF mass spectrometry|Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.
16265363|NCT00898417|Biological|bevacizumab|
16265364|NCT00898417|Drug|carboplatin|
16265365|NCT00898417|Drug|paclitaxel|
16265366|NCT00898417|Genetic|proteomic profiling|
16265367|NCT00898417|Other|laboratory biomarker analysis|
16265368|NCT00898417|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16265369|NCT00898404|Other|laboratory biomarker analysis|Correlative studies
16265370|NCT00898391|Other|laboratory biomarker analysis|Correlative studies
16265371|NCT00898391|Genetic|polymerase chain reaction|Correlative studies
16265372|NCT00898391|Genetic|polyacrylamide gel electrophoresis|Correlative studies
16265373|NCT00898391|Genetic|DNA analysis|Correlative studies
16265374|NCT00898378|Genetic|gene expression analysis|gene expression analysis
16265375|NCT00898378|Genetic|polymerase chain reaction|polymerase chain reaction
16265376|NCT00898378|Genetic|polymorphism analysis|polymorphism analysis
16265377|NCT00898378|Genetic|protein expression analysis|protein expression analysis
16265378|NCT00898378|Genetic|proteomic profiling|proteomic profiling
16265379|NCT00898378|Other|gas chromatography|gas chromatography
16265380|NCT00898378|Other|laboratory biomarker analysis|laboratory biomarker analysis
16265381|NCT00898378|Other|liquid chromatography|liquid chromatography
16265382|NCT00898378|Other|mass spectrometry|mass spectrometry
16265383|NCT00898378|Other|questionnaire administration|questionnaire administration
16265384|NCT00898365|Other|Cytology Specimen Collection Procedure|Correlative studies
16265385|NCT00898365|Other|Laboratory Biomarker Analysis|Correlative studies
16265386|NCT00898352|Procedure|regional lymph node dissection|
16265387|NCT00898352|Radiation|radiation therapy|
16265388|NCT00898326|Other|biopsy|Conduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible.
16265389|NCT00898313|Genetic|comparative genomic hybridization|Collection of sputum, blood, urine, and a small amount of lung tissue.
16265390|NCT00898313|Genetic|gene expression microarray analysis|Collection of sputum, blood, urine, and a small amount of lung tissue.
16265391|NCT00898313|Genetic|proteomic profiling analysis|Collection of sputum, blood, urine, and a small amount of lung tissue.
16265392|NCT00898313|Other|biologic sample preservation procedure|Collection of sputum, blood, urine, and a small amount of lung tissue.
16265393|NCT00898313|Procedure|nasal brushing|Using a brush, superficial cells are removed from the nose.
16265394|NCT00898313|Procedure|Blood draw|Venous blood will be collected
16265395|NCT00898313|Procedure|Urine collection|Subjects will be asked to provide a urine specimen.
16265396|NCT00898313|Procedure|sputum sample|Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
16265397|NCT00898313|Procedure|fluorescence bronchoscopy with airway biopsy|A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.
16265398|NCT00898313|Procedure|fine needle aspiration of the lung|A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.
16265399|NCT00898313|Procedure|thoracentesis|A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it.
16265400|NCT00898300|Other|biologic sample preservation procedure|
16265401|NCT00898300|Procedure|biopsy|
16265402|NCT00898287|Drug|P276-00|Subjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/ m 2/day x 5 q 3 weeks Level 2 - 140 mg/ m2/day x 5 q 3 weeks Level 3 - 185 mg/ m2 /day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity.
16265473|NCT00897936|Other|diagnostic laboratory biomarker analysis|
16265474|NCT00897936|Other|immunologic technique|
16265475|NCT00897923|Procedure|radionuclide imaging|
16265403|NCT00898287|Drug|Gemcitabine|Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m 2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.
16265404|NCT00898274|Other|immunoenzyme technique|Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.
16265405|NCT00898274|Other|laboratory biomarker analysis|Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.
16265406|NCT00898261|Genetic|microarray analysis|
16265407|NCT00898261|Genetic|reverse transcriptase-polymerase chain reaction|
16265408|NCT00898261|Other|flow cytometry|
16265409|NCT00898235|Genetic|clonality analysis|analyze clonality
16265410|NCT00898235|Genetic|polymerase chain reaction|analyze polymerase chain reaction
16265411|NCT00898235|Genetic|protein analysis|analyze protein
16265412|NCT00898235|Other|biologic sample preservation procedure|preserve biologic samples
16265413|NCT00898235|Other|laboratory biomarker analysis|analyze laboratory biomarkers
16265414|NCT00898235|Procedure|fluorescence spectroscopy|perform fluorescence spectroscopy on specimens
16265415|NCT00898235|Procedure|quality-of-life assessment|assess quality of life at each follow-up for life
16265416|NCT00898222|Drug|aspirin|81 mg orally daily for two weeks
16265417|NCT00898209|Genetic|protein expression analysis|Blood and exhaled breath condensate will be collected.
16265418|NCT00898209|Genetic|proteomic profiling|Blood and exhaled breath condensate will be collected.
16265419|NCT00898209|Other|biologic sample preservation procedure|Blood and exhaled breath condensate will be collected.
16265420|NCT00898209|Other|laboratory biomarker analysis|Blood and exhaled breath condensate will be collected.
16265421|NCT00898209|Other|matrix-asst laser desorption/ionization time flight mass spectrometry|Blood and exhaled breath condensate will be collected.
16265422|NCT00898209|Other|questionnaire administration|Questionnaire will be completed.
16265423|NCT00898183|Genetic|gene expression analysis|
16265424|NCT00898183|Genetic|polymorphism analysis|
16265425|NCT00898170|Procedure|myoma removal|surgical removal of myoma by hysterectomy
16265426|NCT00898157|Other|laboratory biomarker analysis|
16265427|NCT00898144|Other|Papanicolaou test|
16265428|NCT00898144|Other|laboratory biomarker analysis|
16265429|NCT00898118|Genetic|polymerase chain reaction|
16265430|NCT00898118|Other|flow cytometry|
16265431|NCT00898118|Other|laboratory biomarker analysis|
16265432|NCT00898118|Procedure|allogeneic hematopoietic stem cell transplantation|
16265433|NCT00898092|Genetic|microarray analysis|
16265434|NCT00898092|Genetic|molecular genetic technique|
16265435|NCT00898092|Genetic|mutation analysis|
16265436|NCT00898092|Genetic|polymerase chain reaction|
16265437|NCT00898092|Genetic|reverse transcriptase-polymerase chain reaction|
16265438|NCT00898092|Other|diagnostic laboratory biomarker analysis|
16265439|NCT00898079|Other|Cytology Specimen Collection Procedure|Correlative studies
16265440|NCT00898066|Genetic|cytogenetic analysis|marrow and peripheral blood
16265441|NCT00898066|Genetic|fluorescence in situ hybridization|marrow and peripheral blood
16265442|NCT00898053|Other|laboratory biomarker analysis|Correlative studies
16265443|NCT00898040|Genetic|polymorphism analysis|
16265444|NCT00898027|Other|laboratory biomarker analysis|laboratory biomarker analysis
16265445|NCT00898014|Genetic|fluorescence in situ hybridization|
16265446|NCT00898014|Other|immunologic technique|
16265447|NCT00898014|Other|laboratory biomarker analysis|
16265448|NCT00897988|Genetic|gene expression analysis|
16265449|NCT00897988|Genetic|mutation analysis|
16265450|NCT00897988|Genetic|polyacrylamide gel electrophoresis|
16265451|NCT00897988|Genetic|polymerase chain reaction|
16265452|NCT00897988|Genetic|protein expression analysis|
16265453|NCT00897988|Genetic|reverse transcriptase-polymerase chain reaction|
16265454|NCT00897988|Other|flow cytometry|
16265455|NCT00897988|Other|immunoenzyme technique|
16265456|NCT00897988|Other|immunologic technique|
16265457|NCT00897988|Other|laboratory biomarker analysis|
16265458|NCT00897988|Other|pharmacological study|
16265459|NCT00897975|Dietary Supplement|red yeast rice|600 mg 3 capsules bid
16265460|NCT00897975|Drug|phytosterol|phytosterol 450 mg 2 tabs bid with food
16265461|NCT00897975|Behavioral|therapeutic lifestyle program|TLC - 12 weeks
16265462|NCT00897975|Drug|placebo|placebo
16265463|NCT00897962|Other|Healthy Controls|One blood draw (2 teaspoons)
16265464|NCT00897962|Other|Metastatic Breast Cancer|Blood samples will be drawn every 3 months, for up to 18 months.
16265465|NCT00897962|Other|Non-cancer medical illness|One blood draw (2 teaspoons)
16265466|NCT00897949|Drug|rizatriptan benzoate (MK0462)|Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.
16265467|NCT00897949|Drug|Comparator: placebo|Placebo to rizatriptan
16265468|NCT00897936|Genetic|DNA methylation analysis|
16265469|NCT00897936|Genetic|comparative genomic hybridization|
16265470|NCT00897936|Genetic|fluorescence in situ hybridization|
16265471|NCT00897936|Genetic|microarray analysis|
16265472|NCT00897936|Genetic|polymerase chain reaction|
16265476|NCT00897923|Radiation|indium In 111-labeled autologous peripheral blood mononuclear cells|
16265477|NCT00897923|Radiation|indium In 111-labeled autologous polymorphonuclear leukocytes|
16265478|NCT00897910|Other|flow cytometry|Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
16265479|NCT00897910|Other|immunoenzyme technique|Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
16265480|NCT00897910|Other|laboratory biomarker analysis|Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
16265481|NCT00897897|Device|Philips MRI-guided HIFU system|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
16265482|NCT00897884|Drug|Metformin|500 mg tablet, taken 3 times a day for 2-3 weeks
16265483|NCT00897871|Drug|carboplatin|
16265484|NCT00897871|Drug|cyclophosphamide|
16265485|NCT00897871|Drug|etoposide phosphate|
16265486|NCT00897871|Genetic|gene expression analysis|
16265487|NCT00897871|Genetic|polymorphism analysis|
16265488|NCT00897871|Other|pharmacological study|
16265489|NCT00897845|Genetic|RNA analysis|
16265490|NCT00897845|Genetic|microarray analysis|
16265491|NCT00897845|Other|immunohistochemistry staining method|
16265492|NCT00897845|Other|laboratory biomarker analysis|
16265493|NCT00897832|Other|laboratory biomarker analysis|Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), it will be determined if pre-treatment markers can be used to correlate with clinical outcomes of survival and recurrence. Examples of such markers include studying if the integrity of DNA repair pathway in pancreatic cancers, analyzed by Rad51 and phosphorylated DNA-PK foci formation, correlates with tumor response to radiotherapy, chemotherapy, and overall survival.
16265494|NCT00897819|Genetic|DNA methylation analysis|
16265495|NCT00897819|Genetic|loss of heterozygosity analysis|
16265496|NCT00897819|Genetic|microsatellite instability analysis|
16265497|NCT00897819|Other|laboratory biomarker analysis|
16265498|NCT00897806|Genetic|Microarray analysis|
16265499|NCT00897806|Other|Laboratory biomarker analysis|
16265500|NCT00897793|Procedure|venipuncture|Venipuncture for blood samples. Samples will be tested for TGF-beta.
16265501|NCT00897793|Radiation|radiation therapy|Radiation treatments vary according to type of cancer and by patient per doctors' recommendation
16265502|NCT00897780|Behavioral|Biofeedback with virtual reality|Participant will use biofeedback technique in combination with virtual reality technique
16265503|NCT00897767|Other|biologic sample preservation procedure|
16265504|NCT00897754|Genetic|gene expression analysis|
16265505|NCT00897754|Genetic|protein expression analysis|
16265506|NCT00897754|Genetic|reverse transcriptase-polymerase chain reaction|
16265507|NCT00897754|Other|immunoenzyme technique|
16265508|NCT00897754|Other|immunohistochemistry staining method|
16265509|NCT00897754|Other|immunologic technique|
16265510|NCT00897741|Genetic|microarray analysis|
16265511|NCT00897741|Other|laboratory biomarker analysis|
16265512|NCT00897728|Other|laboratory biomarker analysis|
16265513|NCT00897715|Drug|Rilonacept|160 mg of rilonacept administered subcutaneously once a week for 12 weeks
16265514|NCT00897715|Drug|Placebo|160 mg of placebo administered subcutaneously once a week for 12 weeks
16265515|NCT00897702|Other|Blood draw|A single 10ml tube of blood will also be obtained for a comparison of patient's normal DNA for genomic analyses either at the time of the procedure or at a followup appointment if feasible.
16265516|NCT00897702|Other|immunoenzyme technique|
16265517|NCT00897702|Procedure|biopsy|
16265518|NCT00897702|Procedure|histopathologic examination|
16265519|NCT00897676|Drug|Exendin-(9-39)|100-500pmol/kg/min
16265520|NCT00897676|Drug|placebo|placebo (0.9% NaCl)
16265521|NCT00897663|Genetic|gene expression analysis|
16265522|NCT00897663|Genetic|microarray analysis|
16265523|NCT00897663|Genetic|protein expression analysis|
16265524|NCT00897663|Other|diagnostic laboratory biomarker analysis|
16265525|NCT00897663|Other|immunohistochemistry staining method|
16265526|NCT00897650|Genetic|DNA/RNA sequencing and expression levels|Lung tumor tissue will be collected.
16265527|NCT00897650|Genetic|Protein expression analysis|Lung tumor tissue will be collected.
16265528|NCT00897650|Procedure|Lung tumor biopsy|Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed
16265529|NCT00897650|Procedure|Blood sample|Patients will be asked for a venous blood sample
16265530|NCT00897637|Other|laboratory biomarker analysis|Correlative studies
16265531|NCT00897624|Genetic|gene expression analysis|
16265532|NCT00897624|Genetic|reverse transcriptase-polymerase chain reaction|
16265533|NCT00897624|Other|laboratory biomarker analysis|
16265534|NCT00897611|Procedure|DNA methylation analysis|
16265535|NCT00897611|Procedure|polymerase chain reaction|
16265536|NCT00897611|Procedure|computed tomography|
16265537|NCT00897611|Procedure|magnetic resonance imaging|
16265538|NCT00897559|Genetic|gene expression analysis|
16265539|NCT00897559|Genetic|mutation analysis|
16265540|NCT00897559|Genetic|polymorphism analysis|
16265541|NCT00897559|Genetic|protein analysis|
16265542|NCT00897559|Other|flow cytometry|
16265543|NCT00897559|Other|laboratory biomarker analysis|
16265544|NCT00897546|Other|laboratory biomarker analysis|
16265545|NCT00897533|Genetic|gene mapping|
16265546|NCT00897533|Genetic|polymorphism analysis|
16265547|NCT00897533|Other|diagnostic laboratory biomarker analysis|
16265548|NCT00897533|Other|immunohistochemistry staining method|
16265549|NCT00897520|Biological|recombinant interferon alfa|
16265550|NCT00897520|Genetic|proteomic profiling|
16265551|NCT00897520|Other|immunoenzyme technique|
16265552|NCT00897520|Other|laboratory biomarker analysis|
16265553|NCT00897507|Genetic|polymorphism analysis|
16265554|NCT00897494|Genetic|protein expression analysis|Venous blood collection
16265555|NCT00897494|Other|laboratory biomarker analysis|Venous blood collection
16265556|NCT00897494|Other|mass spectrometry|Venous blood collection
16265557|NCT00897494|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|Venous blood collection
16265558|NCT00897481|Genetic|gene expression analysis|
16265559|NCT00897481|Genetic|mutation analysis|
16265560|NCT00897481|Other|diagnostic laboratory biomarker analysis|
16265561|NCT00897481|Other|immunohistochemistry staining method|
16265562|NCT00897481|Procedure|sentinel lymph node biopsy|
16265563|NCT00897468|Other|laboratory biomarker analysis|Tissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies. A sample of urine will also be obtained. Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells.
16265564|NCT00897468|Other|medical chart review|patient chart review will occur in conjunction with patient data collection for final analyses.
16265565|NCT00897455|Genetic|DNA analysis|
16265566|NCT00897455|Genetic|mutation analysis|
16265567|NCT00897455|Genetic|polymorphism analysis|
16265568|NCT00897455|Other|laboratory biomarker analysis|
16265569|NCT00897455|Procedure|evaluation of cancer risk factors|
16265570|NCT00897442|Other|Laboratory Biomarker Analysis|Correlative studies
16265571|NCT00897429|Procedure|laboratory biomarker analysis|Correlative studies
16265572|NCT00897416|Other|laboratory biomarker analysis|
16265573|NCT00897403|Other|biologic sample preservation procedure|
16265574|NCT00897403|Procedure|diagnostic colonoscopy|
16265575|NCT00897390|Drug|Saxagliptin|Tablet, Oral, 2.5 mg, Once Daily, 1 week
16265576|NCT00897390|Drug|Metformin IR (glucophage)|Tablets, Oral, 1000 mg, Once Daily, 1 week
16265577|NCT00897390|Drug|Saxagliptin + Metformin IR (FDC)|Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week
16265578|NCT00897377|Radiation|Radiation therapy|
16265579|NCT00897377|Drug|Temozolomide|
16265580|NCT00897351|Genetic|mutation analysis|
16265581|NCT00897351|Genetic|polymorphism analysis|
16265582|NCT00897351|Genetic|protein expression analysis|
16265583|NCT00897351|Other|immunohistochemistry staining method|
16265584|NCT00897351|Other|laboratory biomarker analysis|
16265585|NCT00897338|Other|flow cytometry|laboratory analysis
16265586|NCT00897338|Other|fluorescence activated cell sorting|laboratory analysis
16265587|NCT00897338|Other|immunohistochemistry staining method|laboratory analysis
16265588|NCT00897338|Other|immunologic technique|laboratory analysis
16265589|NCT00897338|Other|biomarker analysis|laboratory analysis
16265590|NCT00897325|Other|Cytology Specimen Collection Procedure|Correlative studies
16265591|NCT00897325|Other|Laboratory Biomarker Analysis|Correlative studies
16265592|NCT00897312|Biological|infliximab|
16265593|NCT00897312|Biological|pegylated interferon alfa|
16265594|NCT00897312|Biological|ticilimumab|
16265595|NCT00897312|Drug|ribavirin|
16265596|NCT00897312|Other|high performance liquid chromatography|
16265597|NCT00897312|Other|laboratory biomarker analysis|
16265598|NCT00897299|Genetic|microarray analysis|
16265599|NCT00897299|Genetic|protein expression analysis|
16265600|NCT00897299|Other|immunohistochemistry staining method|
16265601|NCT00897299|Other|laboratory biomarker analysis|
16265602|NCT00897273|Genetic|comparative genomic hybridization|
16265603|NCT00897273|Genetic|gene expression analysis|
16265604|NCT00897273|Other|study of socioeconomic and demographic variables|
16265605|NCT00897273|Procedure|evaluation of cancer risk factors|
16265606|NCT00897273|Procedure|study of high risk factors|
16265607|NCT00897260|Drug|Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders|"To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
~DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
~Fludarabine 40mg/m2 10:00am (After TBI) over 60 minutes x x x x Umbilical cord blood infusion (minimum of 24hrs after Flu infusion) x
~Fludarabine dose adjustment:
~70ml/min: decrease dose by Creatinine Clearance 20% Fludarabine dosing will be based on the 40% adjusted ideal body weight.
~UCB Infusion"
16265608|NCT00897260|Radiation|Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders|DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
16265609|NCT00897260|Procedure|Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders|
16265610|NCT00897247|Genetic|microarray analysis|
16265611|NCT00897247|Genetic|protein expression analysis|
16265612|NCT00897247|Genetic|proteomic profiling|
16265613|NCT00897247|Other|laboratory biomarker analysis|
16265614|NCT00897234|Other|Mass Spectrometry|Levels of Cathepsin D (CD) and fatty acid synthase (FAS) will be measured using isobaric tag labeling coupled with mass spectrometry. RNA concentration will be measured using spectrophometer and purity will be analyzed.
16265615|NCT00897221|Drug|Deferiprone oral solution 100mg/mL|Deferiprone oral solution (20 mg/kg/day)
16265616|NCT00897221|Drug|Deferiprone oral solution 100 mg/mL|Deferiprone oral solution(40mg/kg/day)
16265617|NCT00897208|Other|high performance liquid chromatography|
16265618|NCT00897208|Other|laboratory biomarker analysis|
16265619|NCT00897208|Other|mass spectrometry|
16265620|NCT00897208|Other|medical chart review|
16265621|NCT00897208|Procedure|evaluation of cancer risk factors|
16265622|NCT00897182|Genetic|microarray analysis|
16265623|NCT00897182|Genetic|polymerase chain reaction|
16265624|NCT00897169|Other|Oral Glucose Tolerance Test (OGTT)|A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2
16265625|NCT00897169|Other|Euglycaemic hyperinsulinaemic clamp|A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3
16265626|NCT00897143|Genetic|microarray analysis|analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
16265627|NCT00897143|Genetic|mutation analysis|analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
16265628|NCT00897143|Other|flow cytometry|analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
16265629|NCT00897143|Other|immunologic technique|analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin
16265630|NCT00897130|Drug|Azacytidine|Azacitidine will be given at a dose of 75mg/sqm subcutaneous daily for 5 consecutive days every 28 days (every month) for a total of 8 courses. 5-Aza dosages will be adjusted
16265631|NCT00897117|Genetic|gene expression analysis|Blood and lung tissue collection
16265632|NCT00897117|Genetic|microarray analysis|Blood and lung tissue collection
16265633|NCT00897117|Genetic|protein expression analysis|Blood and lung tissue collection
16265634|NCT00897117|Other|biologic sample preservation procedure|Blood and lung tissue collection
16265635|NCT00897117|Other|laboratory biomarker analysis|Blood and lung tissue collection
16265636|NCT00897117|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Blood and lung tissue collection
16265637|NCT00897104|Drug|rizatriptan benzoate (MK0462)|single dose 5 mg rizatriptan p.o.
16265638|NCT00897104|Drug|Comparator: sumatriptan|single dose 50 mg sumatriptan p.o.
16265639|NCT00897104|Drug|Comparator: Placebo|Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
16265640|NCT00897091|Genetic|comparative genomic hybridization|
16265641|NCT00897091|Genetic|microarray analysis|
16265642|NCT00897091|Genetic|reverse transcriptase-polymerase chain reaction|
16265643|NCT00897091|Other|diagnostic laboratory biomarker analysis|
16265644|NCT00897078|Other|laboratory biomarker analysis|
16265645|NCT00897078|Other|medical chart review|
16265646|NCT00897078|Other|metabolic assessment|
16265647|NCT00897078|Other|questionnaire administration|will be obtained at a single clinic visit
16265648|NCT00897078|Procedure|assessment of therapy complications|
16265649|NCT00897065|Genetic|microarray analysis|
16265650|NCT00897065|Genetic|polymerase chain reaction|
16265651|NCT00897065|Genetic|protein expression analysis|
16265652|NCT00897065|Other|diagnostic laboratory biomarker analysis|
16265653|NCT00897065|Other|fluorescent antibody technique|
16265654|NCT00897065|Other|immunohistochemistry staining method|
16265655|NCT00897065|Other|immunologic technique|
16265656|NCT00897052|Genetic|microarray analysis|Assay RNA obtained from archived formalin fixed paraffin embedded tissue samples
16265657|NCT00897052|Other|laboratory biomarker analysis|The gene expression data will be linked to the clinical information in order to generate profile of recurrence and survival as a biomarker.
16265658|NCT00897039|Other|flow cytometry|
16265659|NCT00897039|Other|immunohistochemistry staining method|
16265660|NCT00897026|Drug|cyclophosphamide|
16265661|NCT00897026|Drug|doxorubicin hydrochloride|
16265662|NCT00897026|Drug|paclitaxel|
16265663|NCT00897026|Genetic|fluorescence in situ hybridization|
16265664|NCT00897026|Other|immunohistochemistry staining method|
16265665|NCT00896987|Drug|lamotrigine (Lamictal)|lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
16265666|NCT00896987|Drug|Carbamazepine (Tegretol)|Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
16265667|NCT00896974|Other|Laboratory Biomarker Analysis|Correlative studies
16265668|NCT00896974|Other|Pharmacological Study|Correlative studies
16265669|NCT00896974|Drug|Retinoid 9cUAB30|Given orally
16265670|NCT00896961|Drug|EF5|
16265671|NCT00896961|Other|diagnostic laboratory biomarker analysis|
16265672|NCT00896961|Other|pharmacological study|
16265673|NCT00896948|Genetic|Southern blotting|
16265674|NCT00896948|Genetic|TdT-mediated dUTP nick end labeling assay|
16265675|NCT00896948|Genetic|gene expression analysis|
16265676|NCT00896948|Genetic|protein expression analysis|
16265677|NCT00896948|Other|flow cytometry|
16265678|NCT00896948|Other|fluorescent antibody technique|
16265679|NCT00896948|Other|immunoenzyme technique|
16265680|NCT00896948|Other|immunohistochemistry staining method|
16265681|NCT00896948|Other|immunologic technique|
16265682|NCT00896935|Other|biologic sample preservation procedure|biologic sample preservation procedure
16265683|NCT00896922|Genetic|microarray analysis|
16265684|NCT00896922|Other|immunohistochemistry staining method|
16265685|NCT00896922|Other|laboratory biomarker analysis|
16265686|NCT00896909|Genetic|gene expression analysis|
16265687|NCT00896909|Genetic|mutation analysis|
16265688|NCT00896909|Genetic|polymerase chain reaction|
16265689|NCT00896909|Other|diagnostic laboratory biomarker analysis|
16265690|NCT00896896|Other|immunologic technique|Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
16265691|NCT00896896|Other|laboratory biomarker analysis|Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
16265692|NCT00896883|Device|Middle Turbinate Implant|Middle Turbinate Implant placement at time of surgery and follow ups.
16265693|NCT00896857|Genetic|RNA analysis|
16265694|NCT00896857|Genetic|polymerase chain reaction|
16265695|NCT00896857|Genetic|protein expression analysis|
16265696|NCT00896857|Genetic|reverse transcriptase-polymerase chain reaction|
16265697|NCT00896857|Genetic|western blotting|
16265698|NCT00896857|Other|immunoenzyme technique|
16265699|NCT00896857|Other|immunohistochemistry staining method|
16265700|NCT00896857|Other|laboratory biomarker analysis|
16265701|NCT00896857|Procedure|breast duct lavage|
16265702|NCT00896844|Behavioral|emotional disclosure|writing about emotional events from the past
16265703|NCT00896844|Behavioral|placebo writing|writing about how they spent their time the previous day
16265704|NCT00896831|Drug|L-ornithine-L-aspartate|L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
16265705|NCT00896831|Drug|placebo|Placebo: 5 g (1 sachet) three times per day for 60 days
16265706|NCT00896818|Genetic|DNA analysis|
16265707|NCT00896818|Genetic|genetic linkage analysis|
16265708|NCT00896818|Genetic|loss of heterozygosity analysis|
16265709|NCT00896818|Genetic|polymorphism analysis|
16265710|NCT00896818|Other|laboratory biomarker analysis|
16265711|NCT00896818|Other|medical chart review|
16265712|NCT00896818|Other|questionnaire administration|
16265713|NCT00896792|Other|counseling intervention|
16265714|NCT00896792|Other|questionnaire administration|
16265715|NCT00896792|Other|survey administration|
16265716|NCT00896792|Procedure|end-of-life treatment/management|
16265717|NCT00896792|Procedure|psychosocial assessment and care|
16265718|NCT00896779|Drug|ranibizumab|"Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months
~Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months"
16265719|NCT00896766|Genetic|loss of heterozygosity analysis|
16265720|NCT00896766|Genetic|microarray analysis|
16265721|NCT00896766|Genetic|polymorphism analysis|
16265722|NCT00896766|Genetic|tumor replication error analysis|
16265723|NCT00896740|Genetic|microarray analysis|
16265724|NCT00896740|Procedure|biopsy|
16265725|NCT00896727|Genetic|gene expression analysis|
16265726|NCT00896727|Genetic|protein expression analysis|
16265727|NCT00896727|Other|fluorescent antibody technique|
16265728|NCT00896727|Other|laboratory biomarker analysis|
16265729|NCT00896714|Device|Closed loop anesthesia|Propofol and Remifentanil are administered automatically using a closed-loop system
16265730|NCT00896701|Other|flow cytometry|
16265731|NCT00896701|Other|immunologic technique|
16265732|NCT00896701|Other|laboratory biomarker analysis|
16265733|NCT00896688|Procedure|cervical medial branch blocks using the Quincke spinal needle|#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.
16265734|NCT00896675|Other|proteomic profiles|blood samples analysis
16265735|NCT00896675|Other|proteomic profiles|blood samples analysis
16265736|NCT00896662|Other|immunologic technique|immunologic technique
16265737|NCT00896662|Other|laboratory biomarker analysis|laboratory biomarker analysis
16265738|NCT00896662|Other|pharmacological study|pharmacological study
16265739|NCT00896649|Other|questionnaire administration|Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
16265740|NCT00896649|Procedure|digital mammography|standard screening mammogram
16265741|NCT00896649|Procedure|positron emission mammography|one-time positron emission mammography to compare recall rates with that of standard mammogram
16265742|NCT00896636|Procedure|Random fine need aspiration (rFNA)|Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).
16265743|NCT00896636|Other|Mammogram|Standard mammography of both breasts to obtain images for breast density measurement.
16265744|NCT00896623|Genetic|mutation analysis|
16265745|NCT00896623|Genetic|polymorphism analysis|
16265746|NCT00896623|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
16265747|NCT00896597|Drug|NRL972|2 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions.
16265748|NCT00896571|Drug|Ethinylestradiol/Gestogene (BAY86-5016)|7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
16265749|NCT00896558|Drug|GSK1322322/placebo|GSK1322322/placebo escalating doses from 500mg to 1500mg
16265750|NCT00896558|Drug|GSK1322322/placebo and midazolam|GSK1322322/placebo and 5mg midazolam
16265751|NCT00896545|Behavioral|5-keys counseling|5-session small group intervention
16265752|NCT00896545|Behavioral|Lifestyle counseling|5-session small group behavioral intervention
16265753|NCT00896532|Drug|Placebo to Romosozumab|Administered by subcutaneous injection QM or Q3M.
16265754|NCT00896532|Drug|Alendronate|Administered orally once a week
16265755|NCT00896532|Drug|Teriparatide|Teriparatide 20 μg administered by subcutaneous injection once a day
16265756|NCT00896532|Drug|Romosozumab|Administered by subcutaneous injection
16265757|NCT00896532|Drug|Denosumab|Denosumab 60 mg administered by subcutaneous injection Q6M
16265758|NCT00896532|Drug|Placebo to Denosumab|Administered by subcutaneous injection Q6M
16265759|NCT00896532|Drug|Zoledronic acid|Zoledronic acid 5 mg administered intravenously
16265760|NCT00896519|Biological|rituximab|
16265761|NCT00896519|Biological|sargramostim|
16265762|NCT00896519|Drug|cyclophosphamide|
16265763|NCT00896519|Drug|doxorubicin hydrochloride|
16265764|NCT00896519|Drug|prednisone|
16265765|NCT00896519|Drug|vincristine sulfate|
16265766|NCT00896519|Genetic|gene expression analysis|
16265767|NCT00896519|Genetic|gene rearrangement analysis|
16265768|NCT00896519|Genetic|polymerase chain reaction|
16265769|NCT00896519|Other|R-CHOP regimen|
16265770|NCT00896519|Other|laboratory biomarker analysis|
16265771|NCT00896493|Drug|anti-thymocyte globulin|ATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg
16265772|NCT00896493|Drug|cyclosporine|5 mg/kg PO or IV
16265875|NCT00895804|Drug|MDMA|capsule, 1.6 mg/kg body weight, single dose
16265773|NCT00896493|Radiation|Lymphoid radiation|TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
16265774|NCT00896480|Biological|Immunotherapeutic GSK2132231A|Administration by intramuscular injection
16265775|NCT00896467|Other|questionnaire administration|
16265776|NCT00896467|Procedure|psychosocial assessment and care|
16265777|NCT00896467|Procedure|quality-of-life assessment|
16265778|NCT00896454|Drug|denosumab|120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.
16265779|NCT00896441|Drug|Citalopram|"Refer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram.
~Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition.
~Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition.
~Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition.
~Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression.
~Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI."
16265780|NCT00896428|Drug|Methoxyverapamil (gallopamil)|200 mg/day (1 tablet 100 mg morning and evening) for 12 months.
16265781|NCT00896428|Drug|Placebo.|1 tablet morning and evening for 12 months
16265782|NCT00896402|Drug|Skin antisepsis with chlorhexidine|Chlorhexidine swabs will be used to antiseptically clean the skin, then cultures of the skin and femoral nerve block catheters will be analyzed via standard microbiological techniques
16265783|NCT00896402|Drug|povidone-iodine|Povidone-iodine swabs will be used to antiseptically clean the skin; then cultures of the skin and femoral nerve catheters will be performed by standard microbiologic techniques
16265784|NCT00896389|Procedure|Salt loading|Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.
16265785|NCT00896389|Drug|Hydrochlorothiazide (HCTZ)|We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
16265786|NCT00896376|Biological|trastuzumab|
16265787|NCT00896376|Other|laboratory biomarker analysis|
16265788|NCT00896376|Other|pharmacological study|
16265789|NCT00896363|Drug|GSK163090 1 mg|Developed for the treatment of Major Depressive Disorder
16265790|NCT00896363|Drug|GSK163090 Placebo|Developed for the treatment of Major Depressive Disorder
16265791|NCT00896363|Drug|GSK163090 3 mg|Developed for the treatment of Major Depressive Disorder
16265792|NCT00896350|Drug|Standard Care Chemoradiation|"External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam boost at discretion of treating physician."
16265793|NCT00896337|Device|Epic™ Nitinol Stent System|The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.
16265794|NCT00896337|Drug|Anti-platelet therapy|Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.
16265795|NCT00896337|Drug|Anti-coagulation therapy|Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.
16265796|NCT00896324|Behavioral|Cognitive Rehabilitation|The cognitive rehabilitation procedure will involve a curriculum of game-like cognitive exercises designed to facilitate graded practice of EF skills including attention, processing speed, mental flexibility, planning and logic. The exercises will be delivered to participants via a secure, password protected website created specifically for this study by the PI. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.
16265797|NCT00896324|Behavioral|Active Neurofeedback Training|Neurofeedback training is a type of biofeedback during which the subjects will be trained to improve cognitive function by implementing certain cognitive strategies while receiving feedback of their own brain activity. This is done using an infrared spectroscopy (NIRS) system. NIRS measurements will be performed using an ETG-4000 NIRS system (Hitachi Medical, Tokyo, Japan), at two wavelengths of near-infrared light (695 and 830 nm). Each participant will have 2 or 3 sessions, each lasting approximately 30 minutes.
16265798|NCT00896324|Behavioral|Neurofeedback Training (placebo / Sham)|Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment.
16265799|NCT00896311|Drug|IV Nitroglycerin|IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
16265800|NCT00896311|Drug|Normal saline|IV injection, initial dose of 1ml, with further doses of 1-3mL, up to a recommended maximum of 10mL
16265801|NCT00896298|Drug|Leptin|Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.
16265802|NCT00896298|Drug|Placebo|Sugar pill
16265803|NCT00896285|Other|Large bore chest drain + NSAID based analgesic regimen|Chest tube greater than 14 French size and ibuprofen.
16265804|NCT00896285|Other|Small bore chest drain + NSAID based analgesic regimen|Chest tube less than or equal to 14 French size and ibuprofen.
16265805|NCT00896285|Other|Large bore chest drain + opiate based analgesic regimen|Chest tube greater than 14 French size and morphine.
16265806|NCT00896285|Other|Small bore chest drain + opiate based analgesic regimen|Chest tube less than or equal to 14 French size and morphine.
16265807|NCT00896259|Other|home based exercise and education program|Individual assessment with physiotherapist with educational information, exercise instruction and prescription provided. Instructed to perform home exercises and walking for 12 weeks. Will be individually tailored to participants, bi-monthly phone calls will be used to monitor and facilitate exercise and walking progression .
16265808|NCT00896246|Drug|Klean-Prep®|Four litres of solution administered orally as a divided dose.
16265809|NCT00896246|Drug|Moviprep®|Two litres of solution administered orally as a divided dose
16265810|NCT00896233|Procedure|MRE|"Part 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans.
~Part 2: Participants will have a screening visit, followed ~1
~month later by one imaging visit. The imaging visit will consist
~of two liver MRE scans."
16265811|NCT00896207|Drug|Akt inhibitor SR13668|Given orally as a single dose
16265812|NCT00896194|Behavioral|Standard Behavioral Treatment|SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes).
16265813|NCT00896194|Behavioral|Modified Standard Behavioral Intervention + Self-Efficacy|This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling.
16265814|NCT00896181|Drug|docetaxel|Given IV
16265815|NCT00896181|Drug|cisplatin|Given IV
16265816|NCT00896181|Drug|carboplatin|Given IV
16265817|NCT00896181|Drug|fluorouracil|Given IV
16265818|NCT00896181|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal or intensity-modulated radiotherapy
16265819|NCT00896181|Radiation|intensity-modulated radiation therapy|Undergo 3-dimensional conformal or intensity-modulated radiotherapy
16265820|NCT00896168|Drug|Infliximab|Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
16265821|NCT00896168|Drug|Methotrexate|MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
16265822|NCT00896155|Drug|Tamoxifen|260 patients of breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. ARM 1 will receive Tamoxifen 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.
16265823|NCT00896155|Radiation|Radiotherapy|260 patients of breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. ARM 1 will receive Tamoxifen 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.
16265824|NCT00896129|Other|HRQOL Survey Packet|Questionnaires
16265825|NCT00896077|Drug|Lisofylline|Lisofylline via i.v. administration vs Lisofylline vs s.c. administration
16265826|NCT00896064|Biological|Pneumococcal vaccine GSK2189242A (formulation 1)|One dose will be administered intramuscularly at Study Day 0.
16265827|NCT00896064|Biological|Pneumococcal vaccine GSK2189242A (formulation 2)|One dose will be administered intramuscularly at Study Day 0.
16265828|NCT00896051|Drug|Atazanavir (ATV) 300 mg|Atazanavir (ATV) 300 mg taken by mouth following a meal each morning for 2 weeks during the Pre-Treatment Period and for 48 weeks during the Treatment Period. If participating in the optional substudy, participants will take ATV 300 mg by mouth following a meal each morning on Substudy Days -1 to 7.
16265829|NCT00896051|Drug|Atazanavir (ATV) 400 mg|Atazanavir (ATV) 400 mg taken by mouth following a meal each morning for 2 weeks during the Pre-Treatment Period and for 48 weeks during the Treatment Period. If participating in the optional substudy, participants will take ATV 400 mg by mouth following a meal each morning on Substudy Days -1 to 7.
16265830|NCT00896051|Drug|Ritonavir (rtv) 100 mg|Ritonavir (rtv) 100 mg taken by mouth following a meal each morning for 2 weeks during the Pre-Treatment Period and for 48 weeks during the Treatment Period. If participating in the optional substudy, participants will take rtv 100 mg by mouth following a meal each morning on Substudy Days -1 to 7.
16265831|NCT00896051|Drug|Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs)|2 investigator-selected NRTIs taken as specified in the individual product labels for 2 weeks during the Pre-Treatment Period followed by 1 investigator-selected NRTI (of the 2 NRTIs in the Pre-Treatment Phase) taken as specified in the individual product label for 48 weeks during the Treatment Period. If participating in the optional substudy, participants will take 1 investigator-selected NRTI (of the 2 NRTIs in the Pre-Treatment Phase) mg taken as specified in the individual product label during the Substudy.
16265832|NCT00896051|Drug|Etravirine (ETR) 200 mg|Etravirine (ETR) 200 mg taken twice daily as two 100-mg tablets following a meal (morning and evening) for at least the first two weeks of the 48-week Treatment Period. If participating in the optional substudy, participants will take ETR 200 mg twice daily as two 100-mg tablets following a meal each morning and evening on Substudy Days -1 to 7.
16265833|NCT00896051|Drug|Tenofovir disoproxil fumarate (TDF) 300 mg|Tenofovir disoproxil fumarate (TDF) 300 mg taken by mouth following a meal each morning on Substudy Days 1 to 7.
16265834|NCT00896038|Drug|Aprepitant|Aprepitant is a neurokinin 1 receptor antagonist shown to have anti-stress actions in preclinical studies, and antidepressant efficacy in human clinical trials
16265835|NCT00896038|Drug|Placebo|Non-active placebo
16265836|NCT00896025|Drug|N-acetylcysteine|"Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.
~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.
~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour
~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours
~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours
~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
16265876|NCT00895804|Drug|Pindolol|capsule of 20mg pindolol, single dose 1h before MDMA
16265877|NCT00895791|Device|AXXESS Biolimus A9-eluting bifurcation stent|implantation of stent
16265837|NCT00896012|Procedure|Kidney Biopsy|Skin over the kidney will be cleansed and disinfected. The skin and deeper tissue will be numbed with novocaine like solution. A special needle will be inserted guided by ultrasound into the kidney for an instant to withdraw the small specimen.
16265838|NCT00896012|Drug|Rapamune (sirolimus/rapamycin)|Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
16265839|NCT00896012|Drug|Tacrolimus|Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months).
16265840|NCT00895999|Behavioral|Interpersonal Therapy for Pain (IPT-P)|IPT-P focuses on improving relationships as a way to improve depression and pain. The patient and therapist work together to improve communication and enhance relationships and social support. Patients choose a problem focus and goal related to both their pain and depression. Up to 8 IPT-P sessions are provided regardless of ability to pay.
16265841|NCT00895999|Behavioral|Enhanced Support and Connection to Counseling|Research staff connect patients with the Strong Family Therapy Services, Women's Behavioral Health Service, or other appropriate mental health care and reduce potential barriers from making it to the initial appointment. This support includes navigating insurance issues, addressing issues of childcare and transportation, helping to schedule the initial appointment, reminder calls, and follow-up after the scheduled intake. Research staff will also check-in monthly to see if the patients require any additional support to remain in mental health treatment. Up to 8 therapy sessions are covered regardless of ability to pay.
16265842|NCT00895986|Behavioral|Conversation Maps Diabetes Education|The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, Inc (Healthy I) and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) Diabetes Overview, 2) Diabetes and Healthy Eating, 3) Blood Glucose and Monitoring, and 4) The Natural Course of Diabetes (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program.
16265843|NCT00895986|Behavioral|Heart Healthy Living Diabetes Education|The Joslin Clinic offers a series of two 120-minute classes specifically for people with diabetes that address dyslipidemia and blood pressure problems. A registered nurse and/or a registered dietitian teach the classes, which have a formal written curriculum, including PowerPoint slides.
16265844|NCT00895973|Other|Stirrups delivery vs bed delivery|Position of legs at time of vaginal delivery (bed vs stirrups)
16265845|NCT00895960|Drug|Dasatinib|Starting dose of 150 mg/day administered by mouth daily on Days 1 to 28 of every 28 day cycle, beginning on the first day of RT.
16265846|NCT00895960|Radiation|RT (Radiotherapy)|As a part of standard of care, receive 60 Gy radiation therapy Monday-Friday for a total of 30 radiation treatments (about 6 weeks).
16265847|NCT00895960|Drug|TMZ (Temozolomide)|75 mg/m^2 capsules daily by mouth for up to a maximum of 7 weeks beginning first day of RT until RT end followed by 4 weeks off then 150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles.
16265848|NCT00895947|Drug|interferon-alpha|a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks
16265849|NCT00895947|Other|placebo|placebo lozenges for oral dissolution taken once daily for 16 weeks
16265850|NCT00895934|Drug|vorinostat|Given orally
16265851|NCT00895934|Drug|gemtuzumab ozogamicin|Given intravenously (IV)
16265852|NCT00895934|Drug|azacitidine|Given IV or subcutaneously (SC)
16265853|NCT00895921|Drug|Olanzapine|Single intramuscular 10-mg dose
16265854|NCT00895921|Drug|Aripiprazole|Single intramuscular 9.75-mg dose
16265855|NCT00895908|Behavioral|Friendship Group|Social skills training for 30 sessions, held twice per week over 4 to 5 months
16265856|NCT00895908|Behavioral|Academic tutoring|Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
16265857|NCT00895895|Drug|Placebo|Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
16265858|NCT00895895|Drug|SAM-531 1.5 mg|Capsules SAM-531 1.5 mg, once a day during 52 weeks.
16265859|NCT00895895|Drug|SAM-531 3.0 mg|Capsules SAM-531 3.0 mg, once a day during 52 weeks.
16265860|NCT00895895|Drug|SAM-531 5.0 mg|Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
16265861|NCT00895895|Drug|Donepezil|Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.
16265862|NCT00895882|Drug|vaniprevir (MK7009)|vaniprevir 300 mg soft gel capsules twice daily.
16265863|NCT00895882|Drug|Comparator: vaniprevir (MK7009)|vaniprevir 600 mg soft gel capsules twice daily.
16265864|NCT00895882|Drug|Comparator: Pegylated Interferon (peg-IFN) alfa-2a|Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly
16265865|NCT00895882|Drug|Comparator: Ribavirin|Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
16265866|NCT00895882|Drug|Comparator: Placebo to vaniprevir|Placebo to vaniprevir soft gel capsules twice daily.
16265867|NCT00895856|Other|Evaluation of the functional capacity|An evaluation (questionnaire) was performed by the Katz Index of individuals in this group, including personal issues (sex and age) and different levels of functional independence for the elderly in their basic activities of daily living (ABVD's) such as: bathe, dress, use the bathroom for withdrawals, transfers perform, has control of the sphincters and the food itself. Subject themselves, if capable of responding to the issues of consistency index, did. The answers were given to the auxiliary nurse responsible for care to residents.
16265868|NCT00895843|Drug|Brufen retard|Single dose 2 x 800mg tablets 2 hours prior to surgery
16265869|NCT00895843|Drug|ibuprofen|Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
16265870|NCT00895843|Drug|Bupivacaine|Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
16265871|NCT00895830|Drug|APD405|IV
16265872|NCT00895830|Drug|Placebo|IV
16265873|NCT00895817|Drug|Swallowed fluticasone|440 µg twice daily for 8 weeks
16265874|NCT00895817|Drug|Esomeprazole|40 mg once daily for 8 weeks
16265878|NCT00895791|Device|culotte stenting (Xience V)|implantation of stent
16265879|NCT00895778|Other|Neuromuscular blockade with rocuronium and reversal with sugammadex|
16265880|NCT00895752|Drug|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
16265881|NCT00895739|Biological|alemtuzumab|
16265882|NCT00895739|Drug|cyclosporine|
16265883|NCT00895726|Drug|APD209|Oral tablets twice per day for 56 days
16265884|NCT00895713|Drug|intramuscular hepatitis B virus immune globulin|Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months
16265885|NCT00895700|Behavioral|web-based multifactorial intervention|12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
16265886|NCT00895687|Drug|Erlotinib Hydrochloride|Beginning dose of 150 mg taken by mouth daily for 21-day cycle.
16265887|NCT00895687|Drug|Bortezomib|Beginning dose of 1. mg/m^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
16265888|NCT00895674|Drug|Nexavar (Sorafenib, BAY43-9006)|Patients with a diagnosis of advanced RCC
16265889|NCT00895661|Drug|rituximab|Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).
16265890|NCT00895648|Drug|Pemetrexed|500 mg/m² iv infusion every 3 weeks for 3 cycles
16265891|NCT00895648|Drug|Cisplatin|75 mg/m² iv infusion every 3 weeks for 3 cycles
16265892|NCT00895635|Behavioral|Treadmill Exercise Training|60-minute sessions of supervised treadmill exercise training three times a week for 12 weeks
16265893|NCT00895635|Behavioral|Arm Ergometry Exercise Training|60-minute sessions of supervised aerobic arm exercise training using an arm ergometer three times a week for 12 weeks
16265894|NCT00895635|Behavioral|Usual Care|Usual care for PAD
16265895|NCT00895622|Radiation|54 Gy radiotherapy|External beam radiation therapy (EBRT) to a total dose of 54 Gy (RBE) in 30 fractions. 1.8 Gy (RBE) daily, 5 fractions per week, excluding weekends. 3D-CRT or IMRT or Proton allowed.
16265896|NCT00895622|Radiation|60 Gy radiotherapy|External beam radiation therapy using intensity-modulated radiation therapy (IMRT) to a total dose of 60 Gy in 30 fractions. 2.0 Gy daily, 5 fractions per week, excluding weekends.
16265897|NCT00895609|Drug|Sugammadex, Neostigmine, Saline|"Single intravenous injection of either:
~Sugammadex 0.0625 mg/kg (Sgx 0.0625) Sugammadex 0.125 mg/kg (Sgx 0.125) Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 1.0 mg/kg (Sgx 1.0) Neostigmine 5 mg/kg (Neo 5) Neostigmine 8 mg/kg (Neo 8) Neostigmine 15 mg/kg (Neo 15) Neostigmine 25 mg/kg (Neo 25) Neostigmine 40 mg/kg (Neo 40) Saline 0.9% (Saline)"
16265898|NCT00895596|Drug|LB80380|Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg
16265899|NCT00895583|Drug|Tacrolimus|During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days).
16265900|NCT00895583|Drug|Sirolimus|Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months).
16265901|NCT00895583|Drug|Tacrolimus|During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.
16265902|NCT00895570|Drug|modafinil|During each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300).
16265903|NCT00895570|Drug|placebo|During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.
16265904|NCT00895557|Drug|chantix|.5 mg once a day 1 to 3, .5 mg twice a day on days 4 to 7, 1 mg from day 8 to end of treatment
16265905|NCT00895544|Biological|Influenza vaccine (whole virion, Vero cell derived)|Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)
16265906|NCT00895544|Biological|Influenza vaccine (whole virion, Vero cell derived)|Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)
16265907|NCT00895531|Drug|Depodur|7.5 mg Depodur via the epidural catheter
16265908|NCT00895531|Procedure|sciatic nerve block|The sciatic nerve will be identified at the subgluteal level with ultrasound. A point 3 cm lateral and 4 cm caudad will be marked. Patients will be placed in the lateral position. A 18 G Tuohy needle will be inserted at a 45° angle until a peroneal or tibial twitch is obtained at 1.5 mA. Once the current can be reduced to obtain a twitch less than 0.5 mA, a catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
16265909|NCT00895518|Behavioral|Prolonged Exposure (PE) Therapy|Three PE sessions lasting 1 hour each, delivered 1 week apart
16265910|NCT00895505|Drug|Phenprocoumon|Phenprocoumon 3 mg, tablet, INR adjusted
16265911|NCT00895505|Drug|Warfarin-Natrium|Warfarin-Natrium 5 mg, tablet, INR adjusted
16265912|NCT00895479|Procedure|Graft placement surgery plus Trinam therapy|"Trinam arm: graft placement surgery plus 1ml perivascular administration of Trinam vector.
~Control arm: graft placement surgery"
16265913|NCT00895466|Biological|PEP-223/CoVaccine HT|
16265914|NCT00895453|Drug|itraconazole|6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
16265915|NCT00895453|Drug|lactobacillus gasseri|Lactobacillus vaginal tablets monthly given through 6 days
16265916|NCT00895453|Drug|classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)|CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
16265917|NCT00895414|Drug|doxorubicin hydrochloride|Given IV 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.
16265918|NCT00895414|Drug|enalapril maleate|Given orally - Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2. OR Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.
16265919|NCT00895401|Dietary Supplement|Nepro with Carb Steady|Nepro with Carb Steady is a commercially available renal specific oral nutritional supplement designed to meet the nutrient needs of dialysis patients. The supplement is 8 oz and provides 425 kcal and 19 grams of protein.
16265920|NCT00895401|Other|Standard of Care|Standard of Care for malnourished maintenance hemodialysis patients
16265921|NCT00895388|Behavioral|Structured Rehabilitation program|Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
16265922|NCT00895362|Drug|Erlotinib|Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
16265923|NCT00895362|Drug|Cetuximab|Loading dose of 200 mg/m^2 (maintenance 125 mg/m^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.
16265924|NCT00895349|Procedure|CT Abdomen and Pelvis scan + whole body PET-CT scan|Pre-treatment scan
16265925|NCT00895349|Procedure|CT Abdomen and Pelvis scan|Pre-treatment scan
16265926|NCT00895336|Biological|Lactobacillus GG|1 capsule taken twice daily for a minimum of 28 days to a maximum of 35 days.
16265927|NCT00895323|Other|enzyme-linked immunosorbent assay|
16265928|NCT00895323|Other|pharmacological study|
16265929|NCT00895323|Procedure|whole-body scintigraphy|
16265930|NCT00895323|Radiation|iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2|
16265931|NCT00895310|Drug|Ketoconazole|Ketoconazole is taken three times a day by mouth.
16265932|NCT00895310|Drug|Hydrocortisone|Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.
16265933|NCT00895297|Drug|Dasatinib (Sprycel)|100mg of Dasatinib will be administered as tablets, by mouth, once a day (or twice in some cases depending on the stage of the disease) consistently either in the morning or evening for 12 months. Dose of Dasatinib will be modified according to the patients response.
16265934|NCT00895284|Procedure|Robotic hysterectomy|Robotic hysterectomy.
16265935|NCT00895284|Procedure|Standard Hysterectomy|Standard hysterectomy.
16265936|NCT00895258|Behavioral|Individual placement and support plus cognitive training (IPS-CT)|One IPS plus one CT session each week for 12 weeks
16265937|NCT00895258|Behavioral|Individual placement and support plus enhanced support (IPS-ES)|One IPS plus one ES session each week for 12 weeks
16265938|NCT00895245|Drug|fosaprepitant dimeglumine|Given IV
16265939|NCT00895245|Drug|cisplatin|Given IV
16265940|NCT00895245|Drug|palonosetron hydrochloride|Given IV
16265941|NCT00895245|Drug|dexamethasone|Given IV and orally
16265942|NCT00895245|Other|Functional Living Index-Emesis Questionnaire|Ancillary studies
16265943|NCT00895245|Behavioral|Emesis Diary|Ancillary studies
16265944|NCT00895245|Radiation|Radiotherapy|Undergo radiotherapy
16265945|NCT00895232|Drug|Cohort I|
16265946|NCT00895232|Drug|Cohort II|
16265947|NCT00895232|Drug|Cohort III|
16265948|NCT00895219|Other|Breathing re-training|Breathing re-training
16265949|NCT00895219|Other|Breathing re-training and musculoskeletal techniques|Breathing re-training and musculoskeletal physiotherapy techniques including mobilisation techniques to normalise muscle and joint restrictions, doming of the diaphragm to enhance contraction and relaxation, and rib raising to free restriction in rib cage motion.
16265950|NCT00895206|Drug|individual adapted immunosuppression|individual adapted immunosuppression
16265951|NCT00895206|Drug|golden standard therapy|golden standard therapy
16265952|NCT00895193|Other|Apple pectin|Apple pectin 2000mg
16265953|NCT00895193|Drug|Aspirin 325 mg|Aspirin 325 mg
16265954|NCT00895193|Other|Placebo|Placebo
16265955|NCT00895180|Biological|olaratumab|Given IV
16265956|NCT00895180|Biological|ramucirumab|Given IV
16265957|NCT00895167|Dietary Supplement|curcumin|one oral dose of 12 caplets = 12 g curcumin
16265958|NCT00895154|Behavioral|General Tutoring|Participants will be tutored for approximately 8-10 hours per month during the school year.
16265959|NCT00895154|Behavioral|Memory Training|Participants will receive memory training for approximately 8-10 hours per month during the school year.
16265960|NCT00895141|Dietary Supplement|Saturated Fat Diet|Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat
16265961|NCT00895141|Dietary Supplement|Saturated Fat Diet|Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
16265962|NCT00895128|Drug|Erlotinib Hydrochloride|Starting dose of 100 mg taken by mouth 1 time a day every day for 28 day cycle or 50 mg for pediatric patients.
16265963|NCT00895128|Drug|Dasatinib|Starting dose of 50 mg by mouth 1 or 2 times a day every day for 28 day cycle.
16265964|NCT00895115|Dietary Supplement|vitamin E|Given once daily
16265965|NCT00895115|Procedure|sham intervention|No supplementation
16265966|NCT00895102|Drug|ABT-333 Tablet|See Arm Description for more information.
16265967|NCT00895102|Drug|Placebo|See Arm Description for more information.
16265968|NCT00895102|Drug|ABT-333 Capsule|See arm description for more information
16265969|NCT00895089|Drug|Moxifloxacin (Avelox)|moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
16265970|NCT00895089|Drug|ceftriaxone|ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week
16265971|NCT00895076|Drug|dexamethasone|iontophoretic patch and injection
16265972|NCT00895063|Behavioral|Vocal Exercise|This project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection. This is a cross-over study and subjects will be randomly assigned to a group where they will speak continually for one hour or remain silent for one hour following injection. Data on the effectiveness of the exercise will be collected just before each injection and at 2 weeks, 6 weeks, and 3 months following injection.
16265973|NCT00895050|Other|Review of clinical records|
16265974|NCT00895037|Drug|ReFacto AF (Moroctocog alfa)|Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively
16265975|NCT00895024|Behavioral|Phone Interview/Questionnaire|35-minute questionnaire over the phone.
16265976|NCT00895011|Drug|Placebo|One dose 30 minutes prior to initiation of sexual activity
16265977|NCT00895011|Drug|Avanafil|One dose 30 minutes prior to initiation of sexual activity
16265978|NCT00895011|Drug|Avanafil|One dose 30 minutes prior to initiation of sexual activity
16265979|NCT00894998|Biological|heparin sodium - Cristália|Heparin sodium 5000UI - Cristália
16265980|NCT00894998|Biological|Heparin sodium APP|Heparin Sodium 5.000 USP - APP
16265981|NCT00894985|Biological|heparin sodium - blausiegel|heparin sodium 5.000UI
16265982|NCT00894985|Biological|heparin sodium - APP|heparin sodium 5.000 USP - APP
16265983|NCT00894972|Other|Rehabilitation following lumbar disc surgery (discectomy)|Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
16265984|NCT00894959|Biological|Heparin sodium Blausiegel 1|Heparin sodium Blausiegel 1 5.000 UI
16265985|NCT00894959|Biological|Heparin sodium APP|Heparin sodium APP 5.000 USP
16265986|NCT00894946|Procedure|Lipiodol + IVF|IVF preceded by lipiodol
16265987|NCT00894946|Procedure|IVF|IVF alone
16265988|NCT00894933|Device|CONTINUUM™|Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
16265989|NCT00894920|Dietary Supplement|biotin|capsule approximately 30 mcg daily 21 days
16265990|NCT00894920|Dietary Supplement|biotin|capsule 300 mcg daily 21 days
16265991|NCT00894907|Other|PiCCO-parameter-guided volume resuscitation|"Insertion of an arterial PiCCO catheter. Resuscitation using crystalloids and/or colloids with the following goals:
~ITBI: 850-1000 ml/sqm, if ELWI <=12*ml/kg; ITBI 750-850 ml/sqm, if ELWI >12*ml/kg and/or PaO2:FiO2 <200 (*ELWI<=12ml/kg, if MAP>65mmHg without catecholamines; ELWI<=14ml/kg, if catecholamines required for MAP>65mmHg); SVV<10% (only in controlled ventilation and sinus rhythm); MAP>65mmHg (MAP: Mean Arterial Pressure); IAPP >60mmHg (IAPP: Intra-abdominal Perfusion Pressure)"
16265992|NCT00894907|Other|Control-group|"Haemodynamic management without ITBI and ELWI using any other haemodynamic monitoring tool, with the exception of the PiCCO-system.
~Main haemodynamic goals: CVP 8-12 mmHg; MAP >65mmHg;IAPP >60mmHg"
16265993|NCT00894894|Drug|MP-470|escalating daily doses of amuvatinib
16265994|NCT00894894|Drug|amuvatinib (MP-470)|escalating doses of daily amuvatinib
16265995|NCT00894881|Procedure|Gut cleaning as a preparation to colonoscopy [resting energy expenditure (REE)]|resting energy expenditure (REE).
16265996|NCT00894868|Drug|vildagliptin|
16265997|NCT00894868|Drug|placebo of vildagliptin|
16265998|NCT00894855|Behavioral|education about sun protection|This comprehensive education program included a visit with a health educator, on the education van, who gave education about sun safety.
16265999|NCT00894855|Behavioral|biometric feedback|Participants received biometric feedback using a Dermascan Analyzer and Ultra Violet (UV) Reflectance Photography. The Dermascan Analyzer is an educational tool that enhances visibility of skin texture, markings or lesions and is commonly used in health fairs and at schools all over the country. The analyzer highlights the sun damage on the participants skin as dark purple blotches, which the participants are able to see in the mirror placed inside the analyzer. Ultra Violet (UV) Reflectance Photography provides participants with a visual image of their skin damage that can be taken with them.
16266000|NCT00894855|Other|dermatologist skin exam|Full body skin exam.
16266001|NCT00894842|Drug|Pregnenolone|Pregnenolone 50 mg BID x 14 days, followed by Pregnenolone 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Pregnenolone 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)
16266002|NCT00894842|Drug|Placebo|Placebo 50 mg BID x 14 days, followed by Placebo 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Placebo 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)
16266003|NCT00894829|Biological|heparin sodium - Eurofarma|Heparin sodium 5.000 UI - Eurofarma
16266004|NCT00894829|Biological|heparin sodium - APP|Heparin sodium APP 5.000 USP
16266005|NCT00894816|Dietary Supplement|Lactobacillus F19|Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
16266006|NCT00894816|Dietary Supplement|Placebo|Infant cereals without any addition
16266007|NCT00894803|Drug|Eptifibatide|IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
16266008|NCT00894803|Drug|rt-PA|Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.
16266009|NCT00894790|Drug|Celecoxib|celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
16266010|NCT00894790|Drug|oral Diclofenac|diclofenac 75 mg tablet BID (twice a day)
16266011|NCT00894777|Other|Clinical record review|
16266012|NCT00894751|Drug|dexmedetomidine|dexmedetomidine general anesthesia for MRI
16266013|NCT00894751|Drug|propofol|propofol general anesthesia for MRI
16266014|NCT00894738|Procedure|Testing (MRS, US, DEXA, blood tests)|Magnetic Resonance Spectroscopy (MRS) of the liver to determine hepatic triglyceride content; ultrasound (US) of the carotid artery to determine intima-media thickness; dual energy X-ray absorptiometry (DEXA) to determine body composition; fasting lipids, fasting insulin, C-reactive protein, liver enzymes and fibrinogen levels.
16266015|NCT00894725|Procedure|laparoscopic left colonic resection|laparoscopic colonic resection
16266016|NCT00894725|Procedure|open left colonic resection|conventional open colonic resection
16266017|NCT00894712|Other|Sulforaphane-containing broccoli sprout extracts (active agent)|Topical application, prepared with acetone, 280 nml daily, 3 times a week.
16266018|NCT00894712|Device|Vehicle (inactive control)|Subjects will have measurements of skin erythema using a device called a chromometer
16266019|NCT00894699|Drug|Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
16266020|NCT00894699|Drug|Placebo NanoTab™|Single dose of sublingual placebo NanoTab™
16266021|NCT00894686|Biological|FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)|Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.
16266022|NCT00894673|Biological|Heparin sodium Hipolabor|Heparin sodium Hipolabor 5.000 UI/mL
16266023|NCT00894673|Biological|Heparin sodium APP|Heparin sodium APP 5.000 USP
16266024|NCT00894660|Drug|Amodiaquine (Test)|Oral tablet, single dose, 1 X 300 MG
16266025|NCT00894660|Drug|Amodiaquine (Comparator)|Oral tablet, single dose, 2 X 150 MG
16266026|NCT00894647|Drug|imiquimod cream|Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period
16266027|NCT00894647|Drug|placebo cream|cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period
16266028|NCT00894634|Drug|Brompheniramine maleate|
16266029|NCT00894621|Drug|Norepinephrine|Solution administration contend titrated norepinephrine in doses of 0,1 to 0,4 mc/kg/min. Initiated solution 24 hours after beginning mechanical ventilation. Use of the solution during 72 hours.
16266030|NCT00894621|Drug|Placebo|
16266031|NCT00894608|Drug|letrozole + gonadotropins|patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
16266032|NCT00894608|Drug|GnRHa + gonadotropins|patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins
16266033|NCT00894595|Behavioral|Knäkontroll, SISU Idrottsböcker©, Sweden, 2005|The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.
16266034|NCT00894582|Procedure|Components separation hernia repair|Components separation is one method currently employed for repair of massive ventral hernias. In this study we simply measured the volume of patients' abdomen (who were already undergoing this surgery) as well as their pulmonary function both pre and postoperatively.
16266035|NCT00894569|Drug|paclitaxel/carboplatin|6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
16266036|NCT00894569|Drug|cetuximab|cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression
16266037|NCT00894556|Drug|rizatriptan|Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
16266038|NCT00894556|Drug|Comparator: Placebo|Placebo to Rizatriptan
16266039|NCT00894556|Drug|Comparator: Sumatriptan|single dose of generic sumatriptan 100 mg at onset of migraine attack
16266040|NCT00894543|Drug|Escitalopram|10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.
16266041|NCT00894543|Other|Placebo|Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.
16266042|NCT00894530|Drug|Azithromycin ophthalmic solution, 1%|One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
16266043|NCT00894530|Drug|Placebo|One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
16266044|NCT00894517|Biological|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
16266045|NCT00894517|Drug|Placebo (saline)|Saline injected into the prostate on Day 1.
16266046|NCT00894504|Drug|Panitumumab|6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
16266047|NCT00894504|Drug|Carboplatin|AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
16266048|NCT00894504|Drug|Gemcitabine|1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
16266049|NCT00894478|Procedure|Diffusion Tensor Imaging (DTI)|"MR and DTI: MRI and DTI will be done using 3.0T Philips MR scanner (Philips Medical Systems, Best, The Netherlands) using an eight channel head coil. DTI and axial 3D T1 will be performed on patients and controls.
~DTI will be performed using single shot diffusion-weighted echo planar imaging, b=1000s/mm2 and 15 noncollinear directions (TR/TE=10,000/60 ms, slice thickness=2mm, field of view=22cm, matrix=112x112, NEX=2)
~Axial 3D T1 (TR/TE=4.9/2.3 ms, slice thickness=1 mm, field of view = 24 cm, matrix=220x220, NEX=1) Patients will have additional sequences (axial and coronal T2, proton density and FLAIR) as part of their clinical scan"
16266050|NCT00894478|Procedure|Magnetoencephalography|MEG will be performed using a whole-head Omega 151-channel gradiometer system (VSM MedTech, Port Coquitalam, BC, Canada). At least 15 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 625Hz, a bandpass filter of 10 to 70 Hz and a notch filter of 60 Hz.
16266051|NCT00894465|Drug|midazolam|Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
16266052|NCT00894465|Drug|placebo|Children are randomized to receive a placebo prior to undergoing VCUG
16266053|NCT00894439|Drug|BLI-489/Piperacillin|
16266054|NCT00894439|Drug|BLI-489|
16266055|NCT00894439|Drug|Piperacillin|
16266056|NCT00894413|Drug|Tadalafil|20 mg once daily for 10 - 14 days
16266057|NCT00894413|Other|Placebo Pill|Placebo
16266058|NCT00894400|Procedure|catheter ablation|catheter ablation using radiofrequency energy
16266059|NCT00894387|Drug|Aliskiren|Aliskiren 150 mg and Aliskiren 300 mg
16266060|NCT00894387|Drug|Placebo|Placebo
16266061|NCT00894374|Drug|Artesunate (Test)|Oral tablet, single dose, 1 x 100 mg
16266062|NCT00894374|Drug|Artesunate (Comparator)|Oral tablet, single dose, 2 x 50 mg
16266063|NCT00894361|Procedure|TKA surgery with the rotating platform mobile-bearing knee design|Depuy Sigma RP rotating platform design
16266064|NCT00894361|Procedure|TKA surgery with the all-polyethylene tibia knee design|Depuy Sigma fixed-bearing design with all-polyethylene tibia
16266065|NCT00894322|Drug|exenatide once weekly|subcutaneous injection, 10.0 mg, single injection
16266066|NCT00894322|Drug|exenatide once weekly|subcutaneous injection, 2.0 mg, once a week for 12 weeks
16266067|NCT00894322|Other|Placebo|subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks
16266068|NCT00894283|Drug|Enoxaparin|Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.
16266069|NCT00894283|Drug|Fondaparinux|Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.
16266070|NCT00894270|Procedure|Sterile air injection|Injection of 20 microlitres using Novofine 5mm needle of sterile air into either abdomen or thigh using either a pinched or unpinched skin fold and either a vertical or angled approach.
16266071|NCT00894270|Procedure|Placebo injection|Injection of either 20, 40 or 60 IU of placebo media into either abdomen or thigh using either a vertical or angled Novofine 5 mm needle. Leakage of fluid will be blotted and then weighed to establish fluid loss.
16266072|NCT00894270|Device|Novofine needle|Novofine 5mm needle
16266073|NCT00894244|Device|Radiofrequency device|One treatment pass on one arm. 2-5 treatment passes on the other
16266074|NCT00894231|Drug|levocetirizine (Xyzal)|5mg po QD
16266075|NCT00894231|Drug|placebo|sugar tablet
16266076|NCT00894218|Procedure|Arthroplasty|Hip or knee arthroplasty
16266077|NCT00894205|Behavioral|strengthening exercise program|"A low intensity strengthening exercise program based on the Tufts University Strong Bones program. Utilizes small free weights and chair exercises. Participants attend community based class 2-3x/wk for 4 wks."
16266078|NCT00894192|Device|Izon Wavefront-guided lenses|Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.
16266079|NCT00894192|Device|Conventional lenses|We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.
16266080|NCT00894166|Drug|Nicotine Patches|21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
16266081|NCT00894166|Drug|Nicotine patches, then bupropion & nicotine patches (Pre-Quit)|21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
16266082|NCT00894166|Drug|Nicotine patches, then varenicline (Pre-Quit)|21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)
16266083|NCT00894166|Drug|Nicotine patches, then nicotine patches (Pre-Quit)|21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
16266084|NCT00894166|Drug|Nicotine patches, then bupropion & nicotine patches (Post-Quit)|21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
16266085|NCT00894166|Drug|Nicotine patches, then varenicline (Post-Quit)|21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)
16266086|NCT00894166|Drug|Nicotine patches, then nicotine patches (Post-Quit)|21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
16266087|NCT00894153|Drug|chemotherapy plus p53|chemotherapy plus p53
16266088|NCT00894153|Drug|chemotherapy|chemotherapy
16266089|NCT00894153|Radiation|radiotherapy|radiotherapy
16266090|NCT00894140|Device|DePuy Silent™ Hip femoral prosthesis|A short cementless, femoral component for use in total hip arthroplasty
16266091|NCT00894127|Device|CyPath|CyPath diagnostic assay for the early detection of lung cancer using sputum
16266092|NCT00894114|Biological|V520|MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
16266093|NCT00894114|Biological|Comparator: ALVAC-HIV vaccine|A single dose 0.1 intramuscular injection
16266094|NCT00894101|Drug|[F-18] FLT|10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.
16266095|NCT00894088|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 500 mg Tablet
16266096|NCT00894075|Biological|ENB-0040|1mg/kg subcutaneous injection thrice weekly for 6 months
16266097|NCT00894062|Device|Zotarolimus eluting stent (Endeavor resoulte - ZES resolute)|Zotarolimus eluting stent (ZES)
16266098|NCT00894062|Device|Everolimus eluting stent (Xience - EES)|Everolimus eluting stent (EES)
16266099|NCT00894049|Drug|reduced intensity conditionings|comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)
16266100|NCT00894023|Drug|Intracoronary bolus wtih ClearWay™RX catheter|Intracoronary bolus with Clearway catheter
16266101|NCT00894023|Drug|IV abciximab|IV abciximab + infusion
16266102|NCT00894010|Drug|carbamazepine 400mg|
16266103|NCT00894010|Drug|levetiracetam 1000mg|
16266104|NCT00893997|Biological|PR-1 vaccine|0.5 mg injections under the skin once every 3 weeks for a total of 4 vaccinations.
16266105|NCT00893984|Drug|Nebivolol|Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
16266106|NCT00893971|Drug|PT001|Inhaled PT001, single dose
16266107|NCT00893971|Drug|PT005|Inhaled PT005, single dose
16266108|NCT00893971|Drug|PT003|Inhaled PT003, single dose
16266109|NCT00893971|Drug|PT001 + PT005|Inhaled PT001 + PT005, single dose
16266110|NCT00893958|Drug|Mycophenolate Mofetil|Prophylaxis of Organ Rejection
16266111|NCT00893945|Drug|DC/AAT|Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.
16266112|NCT00893945|Drug|DC/AAT-Flu|Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT
16266113|NCT00893945|Drug|DC/KLH|Intradermal injection of Autologous dendritic cell vaccine (DC/KLH) which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.
16266114|NCT00893919|Drug|mycophenolate mofetil|mycophenolate mofetil 250 mg capsule
16266115|NCT00893906|Biological|seasonal trivalent inactivated influenza vaccine|vaccine to be used according to marketed dosage and frequency
16266116|NCT00893906|Biological|inactivated polio vaccine|vaccine to be used according to marketed dosage and frequency
16266117|NCT00893880|Drug|1% gaseous Nitric Oxide blended in Oxygen|1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
16266118|NCT00893867|Drug|DP-b99|1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
16266119|NCT00893867|Drug|Placebo|1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
16266120|NCT00893854|Drug|Diclophenac|
16266121|NCT00893854|Drug|Triamcinolone|
16266122|NCT00893841|Drug|quetiapine (Seroquel) XR|tablets and caplets, take with liquid before bedtime
16266123|NCT00893841|Drug|quetiapine (Seroquel) XR|tablets, take with liquid before bedtime
16266124|NCT00893841|Drug|placebo|placebo
16266125|NCT00893841|Drug|pramipexole dihydrochloride|tablets and caplets, take with liquid before bedtime
16266126|NCT00893802|Other|Scaling and root planning|Intervention will consist of supra and subgingival scaling and root planning performed by a single trained periodontist using Gracey curettes (Hu-Friedy, Chicago, USA) without local or general anesthesia during the second trimester of gestation, followed by professional prophylaxis and oral hygiene instruction. Treatment will be performed only once during study.
16266127|NCT00893789|Drug|Armodafinil|Armodafinil 50 mg/day
16266128|NCT00893789|Drug|Armodafinil|Armodafinil 150 mg/day
16266129|NCT00893789|Drug|Armodafinil|Armodafinil 250 mg/day
16266130|NCT00893789|Other|Placebo|Placebo
16266131|NCT00893776|Other|Task Training|Task training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity.
16266132|NCT00893763|Procedure|Pre-intubation CHX|Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
16266133|NCT00893763|Procedure|Control|No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
16266134|NCT00893750|Behavioral|NET Truth Education|Individual Narrative Exposure and Truth Education in Groups
16266135|NCT00893750|Behavioral|Conflict Resolution and Social Competence Skills|Conflict Resolution and Social Competence Skills in Groups
16266136|NCT00893750|Behavioral|Traditional Ways of Coping|Methods Collected by Local Teachers to Help Vulnerable Children and Youths in Northern Uganda
16266137|NCT00893737|Drug|sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)|Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.
16266138|NCT00893724|Drug|Neutral pills with no medicinal effect|Neutral pills with no medicinal effect
16266139|NCT00893724|Dietary Supplement|Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals|Inosine [SR] - 1[500mg] tablet bid Tocopherols [200IU], Tocotrienol [10mg], CoQ10 [50mg] - combination capsule bid Sustained Release Niacinamide - 1 [750mg] tablet bid Vitamin C - 1 [1000mg] sustained release tablet bid N-acetyl Cysteine - 1 [600mg] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid
16266140|NCT00893724|Drug|Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline|Inosine [SR] - 1 [500mg] tablet bid Tocopherol [200IU], Tocotrienol [10mg], CoQ10 [50mg] combination capsule bid Sustained Release Niacinamide 1 [750mg] tablet bid Vitamin C 1 [1000mg] sustained release tablet bid N-acetyl Cysteine 1 [600mg] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid Minocycline 1 [50mg] tablet qd
16266141|NCT00893711|Other|Lactobacillus reuteri DSM 17938|Lactobacillus reuteri is administered at a dose of 1.000.000.000 colony forming units (CFU) in V drops/day for 21 days
16266142|NCT00893711|Other|Placebo|Placebo is administered in V drops once a day for 21 days. Placebo is inactive, similar to the studied treatment with the same package, taste, characteristics of colour and consistency.
16266143|NCT00893711|Dietary Supplement|L.reuteri + Vit D|
16266144|NCT00893711|Dietary Supplement|Vit D placebo|
16266145|NCT00893698|Procedure|bilateral allotransplantation|bilateral allotransplantation of upper limbs
16266146|NCT00893685|Device|Wireless monitors for disease specific clinical parameters.|Homes of participants will be equipped with wireless monitors for blood pressure, blood oxygen, blood glucose, peak expiratory flow, electrocardiogram, body weight. All vital parameters are monitored on a continuous, at least daily basis and obtained values are transmitted to a monitoring centre. Abnormal values are classified for their health risk and health alarms and/or intervention of health professionals is triggered.
16266147|NCT00893659|Dietary Supplement|wheat bread with beta-glucan|3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months
16266148|NCT00893659|Dietary Supplement|wheat bread without beta-glucan|Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months
16266149|NCT00893646|Behavioral|weight loss counseling|individual monthly lifestyle counseling, face-to-face (6 times, each 45 min) and by telephone (7 times, each 30 min), on how to decrease energy intake and change eating habits to improve quality of dietary fat and carbohydrate, how to increase daily walking steps; and how to improve sleep quality (sleep hygienic tips)
16266193|NCT00893347|Behavioral|Cognitive-behavioural therapy|6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome
16266150|NCT00893620|Device|Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft|These devices will be used in patients with an unsuitable distal sealing site for the standard Zenith(R) iliac leg component proximal to the common iliac bifurcation to maintain internal iliac artery patency with endovascular aneurysm repair.
16266151|NCT00893607|Drug|NRL001|10mg NRL001 was administered as a slow release suppository
16266152|NCT00893594|Drug|sumatriptan with naprosyn|Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
16266153|NCT00893594|Drug|placebo|Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
16266154|NCT00893581|Drug|Quetiapine & Placebo|Bipolar adolescents will be initiated on 100 mg per day of quetiapine (or placebo) and 30 mg/kg (maximum starting dose of 600 mg twice daily) of lithium carbonate (or placebo), depending on randomization assignment. Patients will be given placebo for the medication to which they were not assigned. Quetiapine will be adjusted based on tolerability and response to a target dose of 400-600 mg and lithium will be adjusted to a target dose based on achieving a serum level of 1.0-1.2 mEq/L.
16266155|NCT00893581|Drug|Lithium and Placebo|Bipolar adolescents will be initiated on 100 mg per day of quetiapine (or placebo) and 30 mg/kg (maximum starting dose of 600 mg twice daily) of lithium carbonate (or placebo), depending on randomization assignment. Patients will be given placebo for the medication to which they were not assigned. Quetiapine will be adjusted based on tolerability and response to a target dose of 400-600 mg and lithium will be adjusted to a target dose based on achieving a serum level of 1.0-1.2 mEq/L.
16266156|NCT00893581|Other|Healthy Controls|Healthy control (patients given placebo -- sugar pill intended to mimic drug)
16266157|NCT00893568|Other|resonance magnetic imaging (fMRI),|a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
16266158|NCT00893555|Drug|voriconazole|TDM (through level of 2-5mg/L).
16266159|NCT00893555|Drug|voriconazole (dosing according to the SPC)|No serum concentrations are determined
16266160|NCT00893542|Drug|Mycophenolate Mofetil|mycophenolate mofetil 250 mg capsule
16266161|NCT00893529|Dietary Supplement|lemonade with sugar|250 milliliters of lemonade with sugar daily for 18 months
16266162|NCT00893529|Dietary Supplement|lemonade low in sugar|250 milliliters of lemonade low in sugar daily for 18 months
16266163|NCT00893516|Biological|CHOP + CD4|
16266164|NCT00893516|Drug|CHOP|
16266165|NCT00893503|Procedure|colonoscopy|Patients will provide stool and urine samples and will be scheduled to undergo a colonoscopy. The colonoscopy will be done per standard of care - no study specific procedural requirements imposed.
16266166|NCT00893490|Device|Ahmed Glaucoma Valve (AGV)|AGV implantation
16266167|NCT00893490|Drug|Mitomycin C (MMC)|3 minute MMC application
16266168|NCT00893490|Procedure|amniotic membrane coverage|single layer coverage of amniotic membrane
16266169|NCT00893477|Biological|rituximab|
16266170|NCT00893477|Biological|sargramostim|
16266171|NCT00893477|Genetic|gene expression analysis|
16266172|NCT00893477|Genetic|gene rearrangement analysis|
16266173|NCT00893477|Genetic|polymerase chain reaction|
16266174|NCT00893477|Genetic|polymorphism analysis|
16266175|NCT00893477|Other|laboratory biomarker analysis|
16266176|NCT00893464|Drug|IXAZOMIB|Patients will be administered IXAZOMIB by IV on Days 1, 8, and 15 of a 28-day cycle. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.
16266177|NCT00893451|Drug|cholecalciferol (TillVal-D)|In a randomized, two-way cross-over design participants will take vitamin D3 or placebo twice daily during treatment periods of 10 weeks separated by a washout period of 6 weeks.
16266178|NCT00893451|Drug|Placebo|Placebo orally twice daily
16266179|NCT00893438|Behavioral|FitNet treatment|web-based cognitive behavioural treatment for adolescents with CFS
16266180|NCT00893438|Other|Usual care|Usual care treatment for adolescents with CFS
16266181|NCT00893425|Drug|ramipril|
16266182|NCT00893412|Drug|Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)|1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
16266183|NCT00893412|Procedure|Hysterosalpingography (HSG)|One HSG using a metal canula or balloon catheter, 30 minutes after tablet
16266184|NCT00893412|Drug|Placebo|
16266185|NCT00893399|Drug|Gemtuzumab Ozogamicin (Mylotarg)|"Induction Cycle 1, 2: GO 3mg/m² by intravenous infusion (IVI) on day 1 (total dose 3 mg/m2). Start after etoposide IVI. No dose reduction is foreseen in elderly (> 60 yrs) patients.
~Consolidation 1: GO 3mg/m² by intravenous infusion (IVI) on day 1 (total dose 3 mg/m2). Start after first dose of high-dose cytarabine. No dose reduction is foreseen in elderly (> 60 yrs) patients.
~For all patients experiencing prolonged thrombocytopenia CTC-Grade 3/4 during the first or second induction therapy, which occurs for more than day 35 after start of the cycle, the further cycles of therapy will be administered without Gemtuzumab ozogamicin.
~Consolidation 2, 3: no GO"
16266186|NCT00893399|Drug|standard chemotherapy|Idarubicin, Etoposide, Cytarabine, ATRA, Pegfilgrastim
16266187|NCT00893386|Procedure|LV Lead Extraction|Removal of a LV lead using any tools & techniques.
16266188|NCT00893373|Drug|sorafenib|Standard AML chemotherapy plus sorafenib 400 mg BID
16266189|NCT00893373|Drug|placebo|Standard AML chemotherapy plus placebo
16266190|NCT00893360|Biological|Autologous stem cell infusion|Subjects will receive 12.5 million of autologous (grown from your own heart muscle specimen) cardiosphere-derived stem cells via intracoronary delivery.
16266191|NCT00893360|Biological|Autologous stem cell infusion|Subjects will receive 25 million of autologous (grown from your own heart muscle specimen) cardiosphere-derived stem cells via intracoronary delivery.
16266192|NCT00893347|Behavioral|Treatment as usual|Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.
16266194|NCT00893321|Procedure|Inferior Oblique Muscle Recession and Myectomy|
16266195|NCT00893295|Other|informational intervention|
16266196|NCT00893295|Other|medical chart review|
16266197|NCT00893295|Other|screening questionnaire administration|
16266198|NCT00893295|Other|study of socioeconomic and demographic variables|
16266199|NCT00893295|Procedure|barium enema injection|
16266200|NCT00893295|Procedure|colon imaging study|
16266201|NCT00893295|Procedure|screening colonoscopy|
16266202|NCT00893295|Procedure|sigmoidoscopy|
16266203|NCT00893282|Device|BackStop|BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
16266204|NCT00893282|Device|Intracorporeal lithotripsy without the use of an anti-retropulsion device|
16266205|NCT00893269|Drug|eszopiclone|Oral capsule at dose recommended for adults
16266206|NCT00893269|Drug|Placebo|Participants receive placebo prior to sleep
16266207|NCT00893269|Drug|ramelteon|ramelteon
16266208|NCT00893269|Drug|zolpidem|zolpidem
16266209|NCT00893256|Drug|Risperidone|Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks
16266210|NCT00893256|Drug|risperidone|Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
16266211|NCT00893256|Drug|Citalopram|Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
16266212|NCT00893256|Drug|Placebo|Placebo: once daily
16266213|NCT00893230|Dietary Supplement|probiotic L sakei KCTC 10755BP|freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
16266214|NCT00893230|Dietary Supplement|microcrystalline cellulose (placebo)|freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
16266215|NCT00893217|Drug|Betaseron (Interferon beta-1b, BAY86-5046)|250 mcg
16266216|NCT00893217|Drug|Betaseron (Interferon beta-1b, BAY86-5046)|500 mcg
16266217|NCT00893165|Behavioral|moderate physical activity|bed mounted cycles for physical activity for 30 min during each hemodialysis session
16266218|NCT00893139|Drug|AL-38583 ophthalmic solution 0.05%|
16266219|NCT00893139|Drug|AL-38583 ophthalmic solution 0.10%|
16266220|NCT00893139|Drug|AL-38583 vehicle|Inactive ingredients used as a placebo comparator
16266221|NCT00893126|Procedure|CCTA Scan (Coronary CT Angiogram)|CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).
16266222|NCT00893113|Drug|Placebo|Alfuzosin-matched One tablet once daily
16266223|NCT00893113|Drug|Alfuzosin|10 mg once daily
16266224|NCT00893100|Drug|Diltiazem|2%,3 times daily
16266225|NCT00893087|Device|Triggering mode of the ventilator|10 min of each triggering mode
16266226|NCT00893087|Device|Triggering method of the ventilator|Flow triggering
16266227|NCT00893087|Device|Triggering method of the ventilator|Pressure triggering
16266228|NCT00893087|Device|Triggering method of the ventilator|NAVA triggering
16266229|NCT00893074|Drug|Dronabinol 30mg/day|10mg dronabinol administered 3x/day for 5 days
16266230|NCT00893074|Drug|Dronabinol 60mg/day|20mg dronabinol administered 3x/day for 5 days
16266231|NCT00893074|Drug|Dronabinol 120mg/day|40mg dronabinol administered 3x/day for 5 days
16266232|NCT00893074|Drug|Placebo|placebo dronabinol administered 3x/day for 5 days
16266233|NCT00893061|Drug|anastrozole|Given orally
16266234|NCT00893061|Drug|exemestane|Given orally
16266235|NCT00893061|Drug|letrozole|Given orally
16266236|NCT00893061|Drug|tamoxifen citrate|Given orally
16266237|NCT00893048|Drug|Prednisone|Prednisone, 60 mg, one time at time of diagnosis
16266238|NCT00893048|Drug|Placebo Oral Tablet|Placebo
16266239|NCT00893009|Drug|Theophylline|100 mg twice a day
16266240|NCT00893009|Drug|Placebo|Placebo
16266241|NCT00892996|Drug|dexamethasone|Metoclopramide 10 mg and dexamethasone 5 mg intravenous
16266242|NCT00892996|Drug|dexamethasone 5 mg|Ondansetron 8 mg and dexamethasone 5 mg IV
16266243|NCT00892983|Behavioral|FAB|Standard well child care plus 7 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, and 3, 4, 7, 9, 13, and 18 months post-partum.
16266244|NCT00892983|Behavioral|Sleep|"Standard well child care plus 2 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), and sleep problem prevention at 3 weeks. A sleep problem intervention starting at 6 months was possible for those indicating their child had a sleep problem at 6 months of age. Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months. Intervention after 6 months uses preferentially a technique called parental presence, and if this does not fit family a technique called camping out and finally, if neither of the first two fit family, controlled crying."
16266245|NCT00892970|Drug|Azithromycin ophthalmic solution, 1%|One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
16266246|NCT00892970|Drug|Placebo|One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
16266247|NCT00892957|Biological|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)|The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).
16266248|NCT00892957|Other|Surgical gauze pads|Manual compression with surgical gauze pads
16266249|NCT00892944|Drug|AZD2516|Fractionated single oral dose
16266250|NCT00892931|Drug|Azixa|3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)
16266251|NCT00892918|Drug|Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%|Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.
16266252|NCT00892892|Drug|Rilmenidine|1 mg Rilmenidine per day versus
16266253|NCT00892892|Drug|Nitrendipine|20 mg Nitrendipine per day
16266254|NCT00892879|Device|Laparoscopic cholecystectomy surgery|Single port laparoscopic cholecystectomy surgery versus a standard four port device.
16266255|NCT00892866|Other|Cytology Specimen Collection Procedure|Correlative studies
16266256|NCT00892866|Other|Laboratory Biomarker Analysis|Correlative studies
16266303|NCT00892515|Other|immunoenzyme technique|
16266304|NCT00892515|Other|immunologic technique|
16266257|NCT00892853|Procedure|CT of the bones|A CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study.
16266258|NCT00892840|Drug|BMS-820836|Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
16266259|NCT00892840|Drug|Placebo|Oral Solution, Oral, 0 mg, Once daily, 14 days
16266260|NCT00892827|Drug|Rituximab (Mabthera) , FFP (Fresh Frozen Plasma)|Rituximab (375 mg/m2) with FFP will be given every two weeks
16266261|NCT00892814|Radiation|Partial breast irradiation|40 Gy/15 fractions, 3 weeks
16266262|NCT00892814|Radiation|Whole breast irradiation|40 Gy/15 fractions, 3 weeks
16266263|NCT00892801|Drug|RAD001|Taken by mouth once a day, for 15 days, one day prior to initiation of whole brain radiation therapy at 5 or 10 mg/day during the phase I component. One of these doses will be selected as the maximum tolerable dose and will be selected for the phase II component
16266264|NCT00892801|Radiation|whole-brain radiation therapy|Standard whole brain radiation therapy (WBRT) 30 Gy will be given in ten fractions.
16266265|NCT00892788|Behavioral|contingency management|Prize-based contingency management for weight loss
16266266|NCT00892788|Behavioral|weight loss manual-guided individual therapy sessions|once weekly counseling sessions with research staff
16266267|NCT00892775|Biological|Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)|Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
16266268|NCT00892775|Biological|GSK Biologicals' 208136, new formulation|Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
16266269|NCT00892762|Drug|Travoprost APS 40 micrograms/ml eye drop solution|non-BAK (benzalkonium chloride) medication
16266270|NCT00892762|Drug|Latanoprost 50 micrograms/ml eye drop solution|BAK-preserved medication
16266271|NCT00892749|Drug|ASP1585|oral
16266272|NCT00892736|Other|Laboratory Biomarker Analysis|Correlative studies
16266273|NCT00892736|Other|Pharmacological Study|Correlative studies
16266274|NCT00892736|Drug|Veliparib|Given PO
16266275|NCT00892723|Drug|AZX100 Drug Product|Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16266276|NCT00892723|Drug|Placebo|Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16266277|NCT00892723|Drug|AZX100 Drug Product|Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16266278|NCT00892710|Drug|Pemetrexed|500 mg/m2 IV given over 10 minutes every 21 days
16266279|NCT00892710|Drug|Bevacizumab|15 mg/kg IV every 21 days
16266280|NCT00892710|Drug|Carboplatin|AUC=5 IV every 21 days
16266281|NCT00892697|Drug|Telaprevir|Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).
16266282|NCT00892697|Drug|Peginterferon alfa-2a|Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).
16266283|NCT00892697|Drug|Ribavirin|Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).
16266284|NCT00892684|Dietary Supplement|Omega-3 long chain polyunsaturated fatty acids|2.7g ω-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant
16266285|NCT00892684|Dietary Supplement|Soybean oil (placebo)|2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol
16266286|NCT00892671|Other|Simulation|simulation of airway management and vascular access
16266287|NCT00892658|Drug|Sorafenib|Patients will receive sorafenib alone (following the dose escalation scheme) for one week, followed by 2 weeks of concurrent administration of sorafenib with conformal radiation therapy (6 fractions over two weeks). Sorafenib administration will continue for four weeks following completion of radiation. At three months following radiation, when liver toxicity is assessed, full dose sorafenib (400mg PO BID) will then be initiated and continued until disease progression or serious toxicity occurs, to a maximum time of 12 months.
16266288|NCT00892632|Procedure|ERCP and Confocal imaging|A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree.
16266289|NCT00892619|Procedure|using ILM forceps alone|Using ILM forceps to initiate and complete ILM peel
16266290|NCT00892619|Procedure|Breaking and peeling with end-grasping forceps|Using an instrument to create a break in the ILM followed by peeling of the membrane with end-grasping forceps
16266291|NCT00892606|Drug|Methadone|Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
16266292|NCT00892606|Drug|Morphine|Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
16266293|NCT00892593|Device|Fecal Immunochemical Testing|Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
16266294|NCT00892593|Device|Fecal Immunochemical Testing|Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
16266295|NCT00892580|Drug|STX209|collection of serum for DNA to elucidate a potential biomarker for patients with ASD
16266296|NCT00892567|Biological|9 Peptides from Her-2/neu, CEA, & CTA|Each vaccination will be administered on days 1, 8, 15, 36, 43, and 50. All participants will receive 9 class I MHC-restricted synthetic peptides and a class II MHC-restricted tetanus helper peptide administered in Montanide ISA-51. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site.
16266297|NCT00892554|Dietary Supplement|Docosahexaenoic Acid|Capsules providing 10 mg DHA/kg body weight/day taken once daily
16266298|NCT00892554|Dietary Supplement|Corn/soy oil|Capsules taken once daily
16266299|NCT00892541|Drug|ER OROS paliperidone|
16266300|NCT00892515|Behavioral|exercise intervention|
16266301|NCT00892515|Other|counseling intervention|
16266302|NCT00892515|Other|gas chromatography|
16266305|NCT00892515|Other|laboratory biomarker analysis|
16266306|NCT00892515|Other|mass spectrometry|
16266307|NCT00892515|Other|physiologic testing|
16266308|NCT00892515|Other|questionnaire administration|
16266309|NCT00892515|Other|survey administration|
16266310|NCT00892515|Procedure|dual x-ray absorptometry|
16266311|NCT00892515|Procedure|magnetic resonance imaging|
16266312|NCT00892515|Procedure|study of high risk factors|
16266313|NCT00892502|Drug|Bismuth tablets|1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
16266314|NCT00892502|Drug|Placebo tablets|1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
16266315|NCT00892489|Drug|ER OROS Paliperidone|
16266316|NCT00892476|Dietary Supplement|Calcium Supplementation|"Ca-gluconate powder (molar weight 430.4 g) will be measured with household measuring spoons and added to the feeding mixtures as follows:
~Amount of feeding Actual Weight < 1000 g Actual Weight < 1000 g
~25 ml ¼ tsp 1/8 tsp
~50 ml ½ tsp ¼ tsp
~100 ml 1 tsp ½ tsp
~200 ml 2 tsp 1 tsp"
16266317|NCT00892476|Other|Standard of Care|Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care
16266318|NCT00892463|Drug|Quetiapine (Seroquel) XR|50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day
16266319|NCT00892450|Drug|Oxybutynin and darifenacin|Participants with overactive bladder will take each medication for 4 weeks.
16266320|NCT00892437|Drug|COBI|Cobicistat (COBI) 150 mg tablet administered orally once daily
16266321|NCT00892437|Drug|RTV|Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily
16266322|NCT00892437|Drug|ATV|Atazanavir (ATV) 300 mg capsule administered orally once daily
16266323|NCT00892437|Drug|FTC/TDF|Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
16266324|NCT00892437|Drug|COBI placebo|Placebo to match COBI administered orally once daily
16266325|NCT00892437|Drug|RTV placebo|Placebo to match RTV administered orally once daily
16266326|NCT00892424|Drug|Sorafenib|Sorafenib doses will be 200mg twice daily orally for 28 days in level I, 400 mg in the morning and 200mg in the evening in level II, and 400mg twice daily orally for 28 days in level III . Radiotherapy will be started at day 8, patients will receive a total of 6 fractions over 2 weeks. Patients will be assessed weekly during treatment, 1 month post-tx, then at 3-month intervals for up to a year after tx, and then followed-up at 6-month intervals up to 3 years.
16266327|NCT00892398|Drug|ranibizumab|Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.
16266328|NCT00892398|Procedure|standard care|standard post-operative care after trabeculectomy with mitomycin C
16266329|NCT00892385|Drug|Methoxyamine|For all cycles, TMZ will be given orally for 5 days every 28 days. MX will be given as a single one-hour IV infusion every 28 days. Temozolomide will be administered within 5 minutes following the initiation of methoxyamine.
16266330|NCT00892385|Drug|Temozolomide|Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
16266331|NCT00892359|Drug|Anidulafungin|treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.
16266332|NCT00892346|Procedure|Single ASCT with Thalidomide maintenance|"Single ASCT with Thalidomide maintenance:
~Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv)
~Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral)"
16266333|NCT00892320|Drug|ER OROS paliperidone|
16266334|NCT00892307|Radiation|Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement|Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye
16266335|NCT00892281|Drug|doxycycline (Oracea®) 40 mg modified release as monotherapy|Take once daily in the morning
16266336|NCT00892281|Drug|doxycycline (Oracea®) 40 mg modified release as add-on therapy|Take once daily in the morning
16266337|NCT00892268|Procedure|acupuncture therapy|Undergo acupuncture
16266338|NCT00892268|Procedure|pain therapy|Receive standard care
16266339|NCT00892255|Device|Microwave Ablation|Tumor tissue from the liver is inter-operatively treated with the microwave ablation device to measure the destruction of tissue.
16266340|NCT00892242|Drug|Zoledronic acid|
16266341|NCT00892229|Drug|Misoprostol (given buccally)|400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
16266342|NCT00892229|Drug|Misoprostol (given vaginally)|400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
16266343|NCT00892216|Device|Acupressure (BioBand)|Band will remain on from 20 minutes before surgery until the end of the hospital stay.
16266344|NCT00892216|Device|Acupressure (BioBand)|Band will remain on from 20 minutes before surgery until the end of the hospital stay. The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.
16266345|NCT00892203|Drug|BGG492|
16266346|NCT00892203|Drug|Sumatriptan|
16266347|NCT00892203|Drug|Placebo|
16266348|NCT00892190|Drug|dasatinib (SPRYCEL)|DL0 - 50 mg every 24 hours DL1 (START)- 70 mg every 24 hours DL2 - 100 mg every 24 hours DL3 - 140 mg every 24 hours
16266349|NCT00892190|Drug|all trans retinoic acid (VESANOID)|22.5mg/m2 every 12 hours
16266350|NCT00892177|Biological|bevacizumab|Given intravenously
16266351|NCT00892177|Drug|dasatinib|Given orally
16266352|NCT00892177|Other|placebo|Given orally
16266353|NCT00892164|Device|harmonic scalpel device (FOCUS)|hemostatic device utilized intraoperatively
16266354|NCT00892164|Device|electrothermal bipolar vessel sealing system (LIGASURE PRECISE)|hemostatic device utilized intraoperatively
16266355|NCT00892151|Device|GLUCOFACTS® Deluxe|Diabetes Data Management Software
16266356|NCT00892138|Behavioral|Mindfulness training|7 week course modeled on MBSR according to Kabat-Zinn
16266357|NCT00892125|Drug|paliperidone ER; Carbamazepine|
16266358|NCT00892112|Drug|Intravenous Immunoglobulins|2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days
16266359|NCT00892112|Drug|plasma volume expander|10 ml/kg BW will be administrated on four consecutive days.
16266360|NCT00892099|Drug|Ergocalciferol|50,000 IU tablet given weekly
16266361|NCT00892099|Drug|Ergocalciferol|50,000 IU tablet given monthly
16266362|NCT00892099|Other|Placebo|Placebo equivalent of ergocalciferol, given weekly as one tablet
16266363|NCT00892073|Drug|Diazoxide|Diazoxide will be initiated at half the dose (100 mg per day) for 2 weeks to allow the insulin sensitizing action of metformin to take effect. Dosage will be increased to 200mg daily, divided twice daily with meals for 6 months.
16266364|NCT00892073|Drug|Metformin|Metformin will be initiated at 500 mg twice daily and increased to 1000 mg twice daily over a one week period to minimize gastrointestinal side effects. the 2000mg is to be taken with meals for 6 months.
16266365|NCT00892047|Drug|venlafaxine XR plus aripiprazole|Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.
16266366|NCT00892047|Drug|venlafaxine plus placebo|Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.
16266367|NCT00892021|Drug|NSA-789|
16266368|NCT00892021|Drug|Placebo|
16266369|NCT00892008|Drug|Pregabalin|Pregabalin 75-150 mg BID for at least 2 weeks.
16266370|NCT00891995|Device|Closed loop|Closed loop therapy for up to 4 to 6 days
16266371|NCT00891995|Device|Home glucose monitoring|Standard diabetes management using a home glucose meter.
16266372|NCT00891995|Device|Insulin pump|Insulin pump use for 2 years
16266373|NCT00891995|Device|Continuous glucose monitor|Continuous glucose monitor use for 2 years
16266374|NCT00891982|Drug|CTGel/ BPO Wash|"Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days
~Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days."
16266375|NCT00891982|Drug|Soap Free Cleanser and CTGel|"Soap Free Cleanser will be used once daily in the morning for 28 days
~Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days."
16266376|NCT00891943|Other|Structured lifestyle support|The intervention group will meet with a research nurse on 14 occasions over the 1 year research study, for structured lifestyle support, including dietary, physical activity and behavioral advice. They will also receive a pedometer.
16266377|NCT00891930|Biological|Panitumumab|Panitumumab 6 mg/kg administered via IV infusion over 60 minutes
16266378|NCT00891930|Biological|Ganitumab|AMG 479 12 mg/kg adminstered by IV infusion over 60 minutes
16266379|NCT00891930|Drug|Irinotecan|Irinotecan starting dose of 180 mg/m² adminstered via IV infusion
16266380|NCT00891917|Dietary Supplement|Ubiquinol-10 Syrup|10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months
16266381|NCT00891917|Dietary Supplement|syrup (placebo)|syrup looks exactly like the Ubiquinol-10 Syrup but has no active ingredients or supplementation
16266382|NCT00891904|Biological|cetuximab|Given IV
16266383|NCT00891904|Radiation|stereotactic body radiation therapy|Undergoing Radiotherapy
16266384|NCT00891878|Drug|capecitabine|Given orally
16266385|NCT00891878|Drug|sunitinib malate|Given orally
16266386|NCT00891839|Drug|Bendamustine|Bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
16266387|NCT00891839|Drug|Rituximab|Patients receive 375 mg/m^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
16266388|NCT00891826|Dietary Supplement|Omega-3 fatty acids (EPAX 6015 TG)|The study drug is a food supplement called EPAX 6015 TG. One capsule of EPAX 6015 TG contains 530 mg of EPA (eicosapentaenoic acid) and 150 mg of DHA (docosahexaenoic acid), provided as triglycerides. For the entire study period (12 weeks) patients will receive 4 capsules of EPAX 6015 TG per day.
16266389|NCT00891826|Dietary Supplement|Corn oil|The corn oil capsules look exactly the same as the capsules containing omega-3 fatty acids. For the entire study period patients will receive 4 capsules of corn oil per day.
16266390|NCT00891813|Drug|Zemplar (paricalcitol)|Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
16266391|NCT00891800|Device|Brachytherapy|SIR-Sphere contains radiation of Y-90.
16266392|NCT00891800|Device|SIR-Sphere|Brachytherapy Radiation seeds
16266393|NCT00891787|Dietary Supplement|Probiotic Supplement|
16266394|NCT00891774|Device|EVOLENCE®|Single injection of material into the mid-dermis of the wrinkle - Second 'touch-up' injection is permitted approximately 14-Days later if needed to achieve satisfactory results
16266395|NCT00891761|Drug|Dexamethasone|16 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
16266396|NCT00891761|Drug|Dexamethasone|20 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
16266397|NCT00891761|Drug|IV casopitant (placebo)|IV casopitant (placebo) administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study day 1.
16266398|NCT00891761|Drug|IV casopitant (active)|Single-dose 90 mg IV casopitant administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study Day 1.
16266464|NCT00891267|Drug|Olmesartan medoxomil tablets low dose|Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
16266399|NCT00891761|Drug|Ondansetron|32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1.
16266400|NCT00891748|Genetic|AdCD40L|Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
16266401|NCT00891735|Drug|Ranibizumab|Sterile solution for intravitreal injection.
16266402|NCT00891722|Other|biologic sample preservation procedure|
16266403|NCT00891722|Other|laboratory biomarker analysis|
16266404|NCT00891722|Other|questionnaire administration|
16266405|NCT00891709|Drug|LEO 29102|First-in-man. Healthy volunteers
16266406|NCT00891696|Drug|Rapamycin|Single 16-mg oral dose
16266407|NCT00891696|Other|Amino acid supplementation|Nutritional drink containing essential amino acids
16266408|NCT00891696|Other|Low-intensity resistance exercise|Leg extension exercises on a Cybex leg extension machine
16266409|NCT00891696|Drug|Sodium nitroprusside|Variable rate for 3 hours
16266410|NCT00891696|Device|Blood flow restriction cuff|Blood flow restriction for 5 minutes after the second biopsy
16266411|NCT00891696|Other|Low-intensity resistance exercise|Leg extension exercises on a Cybex leg extension machine
16266412|NCT00891683|Drug|AEG33773 oral dosing|AEG33773 capsules: subjects will receive a daily dose of either 100 mg, 200 mg, or 400 mg AEG33773. Placebo capsules: subjects will receive a daily dose of placebo (matching test product). Capsules will be taken by mouth, over 28 consecutive days
16266413|NCT00891670|Drug|cilostazol|100mg twice daily for at least 1 month
16266414|NCT00891670|Drug|clopidogrel|"75mg once daily (triple group arm)
~150mg once daily (high maintenance dose group arm)"
16266415|NCT00891670|Drug|aspirin|aspirin 100mg
16266416|NCT00891657|Device|SprayShield™|Anti-adhesion barrier
16266417|NCT00891644|Other|Case Management|"Clinical personnel at each AMTU site may work with other personnel from organizations authorized to have access to personal health information to identify clients identified as HIV positive within the past 6 - 18 months.
~Initial contact will be made by persons at source organizations who are authorized to have access to personal health information. Persons so authorized will explain the nature of the research study and request permission from the client for subsequent contact by research personnel from the AMTU site. If permission for contact is received, research personnel at each site will attempt calls as specified by the potential participant or at random times (before 12:00 pm; between 12:00 - 4:00 pm; and between 4:00 - 10:00 pm) for no more than 10 attempts."
16266418|NCT00891644|Other|Snowball sampling|"Snowball sampling assumes that social networks of HIV sero-positive persons in treatment may overlap with those of HIV sero-positive persons not in treatment.
~When a site is assigned to identify HIV positive adolescents not in care by snowball sampling, all HIV positive persons in care at the site will be invited to refer other adolescents known to them as HIV positive, but not in care, for possible participation in the study.
~Printed information containing a brief description of the research in English and in Spanish and contact information of site study personnel will be provided to in-care adolescents at the site for distribution to those known HIV positive adolescents who are not in care."
16266419|NCT00891644|Other|Referral Lists|AMTU staff will develop lists of potential participants at their sites who have had an initial HIV-related health care visit but not received additional visits within the 12 mos prior the list (or before protocol screening) or have completed initial and follow up visits but dropped out of care for 12 or more mos. Back-up lists will be made of potential participants who have gone 9-12 mos and 6-9 mos without a visit. Clinical staff at each AMTU may work with staff from other organizations authorized to access personal health information to find potential participants. 1st contact will be made by persons at source organizations who are authorized to access personal health information. Authorized staff will explain the study and ask permission for contact by research staff at the AMTU site. If so, research staff will attempt calls as specified by the potential participant or at random (before 12 pm; between 12-4 pm; and between 4-10 pm) for no more than 10 attempts.
16266420|NCT00891631|Behavioral|iSBIRT|Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.
16266421|NCT00891631|Behavioral|iSBIRT/TE|Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders
16266422|NCT00891618|Other|Acupuncture|3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
16266423|NCT00891605|Drug|ABT-263|150 mg of ABT-263 is taken orally once daily on Days 1-3 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
16266424|NCT00891605|Drug|paclitaxel|"175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle.
~Note - The dose and schedule is subject to change based on the toxicities observed."
16266425|NCT00891592|Biological|Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells|"Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells.
~Table 6: Dose escalation (Dose level CD3+ cell dose)
~1xE5 cells/kg
~2xE6 cells/kg
~3xE7 cells/kg
~4xE8 cells/kg"
16266426|NCT00891592|Other|Observation Arm|Single infusion of Cord Blood Cells
16266427|NCT00891579|Drug|Pemetrexed (Alimta)|treatment of single pemetrexed with vitamin supplement until discontinued conditions are met
16266428|NCT00891579|Drug|Gefitinib (IRESSA)|treatment of Gefitinib will be applied until discontinued conditions are met
16266429|NCT00891566|Procedure|Immobilization|compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair
16266430|NCT00891553|Procedure|DXA|CR9112792 is a follow-up study of CR9108963, in which the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability were evaluated in comparison with placebo and 2 active comparators, alendronate and teriparatide. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with placebo or ronacaleret (200mg, 300mg, 400mg) to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy, evaluating lumbar spine and hip BMD by DXA. There is no administration of drug in this study.
16266431|NCT00891540|Drug|Ropivacaine|Ropivacaine 0.5%
16266432|NCT00891540|Drug|Ropivacaine|Ropivacaine 0.2%
16266433|NCT00891540|Drug|placebo|Isotonic NaCl
16266434|NCT00891527|Drug|Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)|"Imatinib Mesylate Orange to grayish orange, opaque, 100mg capsules dissolved in 50-100mls of mineral water or apple juice. Given at 340mg/m2 once daily, preferably with a meal.
~Bevacizumab Clear to slightly opalescent liquid. Given at 10mg/kg once every 2 weeks IV. The calculated dose should be placed in an IV bag and diluted with 0.9% sodium chloride to obtain a final volume of 25-100mls. The vials contain no antibacterial preservatives. Once diluted, must be administered within 8 hrs. Initially administered over 90 mins. If no adverse reactions occur, 2nd dose administered over 60 mins. If still no adverse reactions, subsequent doses administered over 30 mins. If infusion-related adverse reactions occur, further infusions administered over the shortest period that was well tolerated."
16266435|NCT00891514|Behavioral|Aerobic Exercise|Treadmill training- begins at 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 45-60 minutes for 6 months
16266436|NCT00891514|Behavioral|Stretching|Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
16266437|NCT00891501|Procedure|Bone Marrow Aspiration|Autologous bone marrow is aspirated from the iliac crest (hip bone) of the patient using a 21-gauge bone marrow aspiration needle under complete aseptic conditions and proper anaesthesia
16266438|NCT00891501|Procedure|Bone marrow mesenchymal stem cell implantation|The culture expanded mesenchymal stem cell pellet will be implanted into the osteochondral knee defect via open surgery or arthroscopically under complete sterile aseptic conditions and proper anaesthesia. The defect will be covered with an autologous periosteal flap from the proximal tibia and then sealed with human fibrin glue to seal the defect and retain the cell pellet in place
16266439|NCT00891475|Procedure|Radiofrequency ablation; Interferon-alpha|Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off till progression. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off till progression. Evaluation for response will be after second cycle.
16266440|NCT00891475|Procedure|Radiofrequency ablation; Sunitinib maleate|Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
16266441|NCT00891475|Drug|Sunitinib maleate|38 patients with unresected primary tumor will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
16266442|NCT00891462|Drug|Aclidinium bromide|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
16266443|NCT00891462|Drug|Aclidinium bromide|Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
16266444|NCT00891462|Drug|Placebo|Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment
16266445|NCT00891436|Drug|Fluticasone furoate nasal spray|2 sprays each nostril every morning for 2 weeks
16266446|NCT00891436|Drug|Placebo nasal spray|2 sprays each nostril every morning for 2 weeks
16266447|NCT00891423|Drug|Meropenem short infusion|
16266448|NCT00891423|Drug|Meropenem extended infusion|
16266449|NCT00891397|Drug|Pregabalin|Dose of 150mg/day divided in two doses. Increased to 300mg/day then to 600mg/day, always divided in two doses for the day.
16266450|NCT00891397|Other|Placebo|Sugar pill
16266451|NCT00891384|Drug|Lenalidomide|Patients will receive maintenance therapy according to their assigned treatment arm: 25 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression.
16266452|NCT00891384|Drug|Lenalidomide|Patients will receive maintenance therapy according to their assigned treatment arm:5 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression
16266453|NCT00891371|Drug|lanreotide (Autogel formulation)|Autogel 120mg
16266454|NCT00891358|Behavioral|Prevention Empowerment Intervention for Young Women|"Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations.
~The three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs."
16266455|NCT00891345|Biological|ALECSAT|Autologous activated CTL and NK-cells injected as a single intravenous injection.
16266456|NCT00891332|Drug|S-1 plus LV (The combination therapy of S-1 and Leucovorin)|S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
16266457|NCT00891319|Device|Electrical stimulator|"• 12-week intervention
~Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
~Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home."
16266458|NCT00891306|Genetic|Alipogene Tiparvovec (AMT-011), Human LPL [S447X]|intra muscular, 1 x E12 gc per kg body weight, injected in a single series of intramuscular injections
16266459|NCT00891306|Drug|mycophenolate mofetil|oral, 2 g/day, day -3 till week 12
16266460|NCT00891306|Drug|cyclosporine|oral, 3 mg/kg/day, day -3 till week 12
16266461|NCT00891306|Drug|methylprednisolone|single intravenous bolus of methylprednisolone (1 mg/kg bodyweight)
16266462|NCT00891293|Drug|Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)|Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
16266463|NCT00891280|Drug|CX-4945 oral formulation|CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.
16266465|NCT00891267|Drug|Olmesartan medoxomil tablets high dose|Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
16266466|NCT00891267|Drug|Amlodipine|Amlodipine tablets taken once daily for 6 weeks
16266467|NCT00891254|Device|Implant of a prosthetic mesh|A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
16266468|NCT00891241|Drug|LMI 1195-101|Single dose, bolus IV injection of LMI 1195
16266469|NCT00891228|Drug|Testosterone|Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
16266470|NCT00891228|Drug|Nestorone®|Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
16266471|NCT00891228|Drug|Nestorone®|Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
16266472|NCT00891228|Drug|Nestorone®|Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
16266473|NCT00891202|Drug|Eliglustat tartrate|PAP: Eliglustat tartrate (ET) capsule 50 mg orally on Day 1 followed by ET 50 mg capsule twice daily (BID) from Day 2 to Week 4, then either ET 50 mg capsule BID (participants with Genz-99067 [active moiety of ET in plasma] trough plasma concentration >=5 ng/mL) or ET 100 mg capsule BID (participants with Genz-99067 trough plasma concentration <5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received ET capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by ET 50 mg or 100 mg capsule BID up to Week 47, then ET 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
16266474|NCT00891202|Drug|Placebo|PAP: Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39. LTTP: Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline for LTTP. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
16266475|NCT00891176|Biological|MenitorixTM|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
16266476|NCT00891176|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
16266477|NCT00891176|Biological|PrevenarTM|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
16266478|NCT00891176|Biological|MeningitecTM|Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
16266479|NCT00891176|Biological|NeisVac-CTM|Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
16266480|NCT00891176|Biological|InfanrixTM hexa|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
16266481|NCT00891176|Biological|InfanrixTM penta|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
16266482|NCT00891176|Biological|InfanrixTM IPV/Hib|Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
16266483|NCT00891176|Biological|InfanrixTM IPV|Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
16266484|NCT00891163|Drug|Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)|30 minute applicable on antecubital fossa
16266485|NCT00891163|Drug|Placebo Patch|placebo
16266486|NCT00891150|Drug|Oxytocin|"Pre-mixed, oxytocin solutions with either 20U/500ml, 30U/500ml or 40U/500ml of Lactated Ringer's solution will be available in the pharmacy department. The bags will be identical in appearance. Each bag will be labeled with a study identification number, from which the pharmacy could determine the administered dose. Subjects as well as the medical providers will be blinded to the assignment of the solution used.
~Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min)."
16266487|NCT00891137|Biological|human myeloid progenitor cells|Single intravenous injection/infusion
16266488|NCT00891111|Behavioral|Direct Payment|$25 gift card given upon completion of Health Risk Assessment
16266489|NCT00891111|Behavioral|Regret Lottery|Entered into a lottery upon completion of Health Risk Assessment
16266490|NCT00891098|Behavioral|Imaginal exposure|7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual
16266491|NCT00891098|Behavioral|Imagery rescripting|7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual
16266492|NCT00891072|Drug|R-(-)-gossypol acetic acid|Given orally
16266493|NCT00891072|Drug|paclitaxel|Given IV
16266494|NCT00891072|Drug|carboplatin|Given IV
16266495|NCT00891072|Other|pharmacological study|Correlative studies
16266496|NCT00891046|Drug|Canakinumab|Canakinumab
16266497|NCT00891033|Drug|Bortezomib (Velcade)|During the study Bortezomib will be administered intravenously as a 3-5 second bolus IV injection, at a dose of 1.0 mg/m2 on days 1, 4, 8, and 11 of each 21-day treatment cycle.
16266498|NCT00891033|Drug|Panobinostat|During the study, panobinostat IV will be administered intravenously as once daily on (day 1 and 8 of the 21 day cycle 2 and beyond). Patients enrolled on first group will receive 5 mg/m2 panobinostat IV, second group 10 mg/m2 panobinostat IV, third group 15 mg/m2 panobinostat IV and the fourth group 20 mg/m2 panobinostat IV. Each infusion of panobinostat will be administered over 30 minutes.
16266499|NCT00891020|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenous every 4 weeks for 24 weeks
16266500|NCT00891020|Drug|tocilizumab [RoActemra/Actemra]|4 mg/kg every 4 weeks for 24 weeks
16266501|NCT00891020|Drug|Nonbiologic DMARDs of investigator's choice|Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
16266502|NCT00891007|Biological|MVA-mBN85B|Low Dose arm, 1x 10E7 TCID50
16266503|NCT00891007|Biological|MVA-mBN85B|Normal Dose arm, 1x 10E8 TCID50
16266504|NCT00891007|Biological|Rouvax|Standard measles vaccine, approved in South Africa
16266505|NCT00890981|Procedure|high-resolution peripheral quantitative computed tomography (HR-pQCT)|Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
16266506|NCT00890981|Procedure|Dual energy X-ray absorptiometry (DXA)|Bone densitometry assessments of the forearm by DXA on day 1.
16266507|NCT00890981|Biological|Denosumab|Denosumab 60 mg subcutaneously every 6 months in the previous study
16266508|NCT00890981|Drug|Placebo|Placebo to denosumab subcutaneously every 6 months in the previous study
16266509|NCT00890968|Drug|Triamcinolone Acetonide (TAC) DuraPeel|topical gel; once daily (nightly); total duration: 4 weeks
16266510|NCT00890968|Drug|Placebo DuraPeel|topical gel; once daily (nightly); total duration: 4 weeks
16266511|NCT00890955|Drug|Amrubicin|"Dose Level -1: 20mg/m2
~Dose Level 1: 25mg/m2
~Dose Level 2: 30mg/m2
~Dose Level 3: 35mg/m2
~Dose Level 4: 40mg/m2
~Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle."
16266512|NCT00890955|Drug|Cyclophosphamide|Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).
16266513|NCT00890942|Drug|naloxone|naloxone 0.4mg.(1 ml) intramuscular
16266514|NCT00890942|Drug|normal saline|normal saline 1 ml IM
16266515|NCT00890929|Drug|Lenalidomide|5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle
16266516|NCT00890929|Drug|Azacitidine|75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle
16266517|NCT00890916|Device|FIRSTHAND System|Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
16266518|NCT00890890|Drug|Avagacestat|Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
16266519|NCT00890890|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
16266520|NCT00890877|Drug|OC000459 or placebo|Pills, active and/or placebo given twice daily for 17 weeks
16266521|NCT00890864|Other|Invitation for breast screening|Invitation for breast screening to women in different age groups
16266522|NCT00890851|Procedure|Transurethral Needle Ablation (TUNA)|Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
16266523|NCT00890838|Dietary Supplement|Omegaven-IV FO|will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
16266524|NCT00890825|Drug|AZD6244|oral capsules, 75mg twice daily
16266525|NCT00890825|Drug|docetaxel|75mg/m2 iv on day 1 of every 21 day cycle
16266526|NCT00890825|Drug|Placebo|placebo
16266527|NCT00890799|Device|Shanghai pmVSD occluder|Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
16266528|NCT00890799|Procedure|surgery|Patient in this group received open surgical repair of pmVSD.
16266529|NCT00890786|Drug|Temozolomide|"High Grade Glioma Temozolomide during radiotherapy: 90mg/m2/day PO daily (for patients ≤ 18 years of age); 75mg/m2/day PO daily (for patients ≥ 19 years of age); must begin by Day 5 of radiotherapy for a total of 42 days consecutively.
~High Grade Glioma Temozolomide during maintenance chemotherapy: 150mg/m2/day PO on Days 1-5."
16266530|NCT00890786|Drug|Bevacizumab|"High Grade Glioma Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Day 22 (± 2 days)and Day 36 (± 2 days) of radiotherapy.
~High Grade Glioma Bevacizumab during maintenance chemotherapy:10 mg/kg as a 90 minute infusion on Day 1 (+ 2 days)and Day 15 (± 2 days) of each course.
~Diffuse Intrinsic Pontine Gliomas Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Days 1 (+ 2 days),15, 29, and 43(±2 days for all 3 doses) of radiotherapy.
~Diffuse Intrinsic Pontine Gliomas Bevacizumab during maintenance chemotherapy: 10 mg/kg as a 90 minute infusion on Day 1 (+2 days)and 15 (±2 days)."
16266531|NCT00890786|Drug|Irinotecan|"High Grade Glioma Irinotecan during maintenance chemotherapy:125 mg/m2/day IV over 90 minutes on Days 1 (+ 2 days)and 15 (±2 days) of each course, given no sooner than one hour after temozolomide on Day 1.
~Diffuse Intrinsic Pontine Gliomas Irinotecan maintenance chemotherapy: 125 mg/m2/day IV on Day 1 (+2 days)and Day 15 (±2 days)."
16266532|NCT00890760|Biological|AdCh63 ME-TRAP|5 x 10*10 vp IM
16266533|NCT00890760|Biological|MVA ME-TRAP|2 x 10*8 pfu ID
16266534|NCT00890760|Other|Sporozoite challenge|Infected mosquito bite
16266535|NCT00890760|Biological|Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly|AdCh63 ME-TRAP 5 x 10*10 vp MVA ME-TRAP 2 x 10*8 pfu
16266536|NCT00890747|Drug|sunitinib malate|Given PO
16266537|NCT00890747|Other|pharmacological study|Correlative studies
16266538|NCT00890747|Other|laboratory biomarker analysis|Correlative studies
16266539|NCT00890734|Drug|CYT003-QbG10|subcutaneous injection
16266540|NCT00890734|Drug|Placebo|subcutaneous injection
16266541|NCT00890721|Drug|SKY0402|During the operation, 30cc of SKY0402 are injected into the wound.
16266542|NCT00890721|Drug|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
16266543|NCT00890708|Drug|Voriconazole (therapeutic drug monitoring)|dosage adjustment according to trough level of voriconazole in plasma
16266706|NCT00889382|Drug|Paclitaxel|Administered intravenously
16266544|NCT00890695|Dietary Supplement|Ready to use supplementary food (RUSF)|It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.
16266545|NCT00890682|Drug|SKY0402|Local infiltration of 8cc SKY0402
16266546|NCT00890682|Drug|Placebo|Local infiltration of 8cc Placebo
16266547|NCT00890669|Other|Treadmill walking training with additional body load|"The training program was divided into three phases (A1-B-A2):
~treadmill training with additional body load (A1),
~control condition (conventional physical therapy group) (B). and
~treadmill training with additional body load again (A2).
~Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle."
16266548|NCT00890656|Drug|Cyclophosphamide (CTX)|300 mg/m^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of
16266549|NCT00890656|Drug|Vincristine|2 mg by vein (IV) weekly for 3: Days 1, 8, 15
16266550|NCT00890656|Drug|Doxorubicin|50 mg/m^2 by vein (IV) over 24 hours
16266551|NCT00890656|Drug|Decadron|80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18
16266552|NCT00890656|Drug|G-CSF|10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours
16266553|NCT00890656|Drug|Methotrexate (MTX)|200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1
16266554|NCT00890656|Drug|Ara-C|3 gm/m^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.
16266555|NCT00890656|Drug|Pegaspargase|2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses
16266556|NCT00890643|Drug|prazosin hydrochloride|prazosin 1-20 mg/day in divided doses
16266557|NCT00890643|Drug|placebo|placebo
16266558|NCT00890630|Procedure|Intracervical Balloon Catheter|Intracervical insertion of an 80cc Double-Balloon Catheter.
16266559|NCT00890630|Drug|Oxytocin|IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
16266560|NCT00890617|Procedure|Cryotherapy (PTC)|CT-guided PTC with the intent to eradicate the entire tumor(s).
16266561|NCT00890617|Drug|Prednisone|"Prednisone taken:
~20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure"
16266562|NCT00890604|Drug|Acetaminophen|APAP 650mg q4h prn; RTC dosing
16266563|NCT00890604|Other|Usual Care|Care per attending physician discretion for fever management
16266564|NCT00890604|Drug|Ibuprofen|Ibuprofen 600mg q6h
16266565|NCT00890604|Other|Physical Cooling Measures|Fan, Ice Packs
16266566|NCT00890604|Device|Cooling Blanket|Water Circulating Cooling Blanket
16266567|NCT00890604|Device|Hydrogel Cooling Pads|Application to torso and extremities
16266568|NCT00890591|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary|olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks
16266569|NCT00890578|Procedure|adhesive to suture|surgical closure
16266570|NCT00890565|Drug|granisetron|Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3
16266571|NCT00890552|Drug|Lenalidomide|"Lenalidomide is a a derivative of thalidomide.
~Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle."
16266572|NCT00890552|Drug|Melphalan|"Melphalan is a phenylalanine derivative of mechlorethamine.
~Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle"
16266573|NCT00890552|Drug|Dexamethasone|"Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.
~Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle"
16266574|NCT00890539|Drug|Methacholine challenge|Clinical and research test used in asthma
16266575|NCT00890526|Other|Sound Therapy (Tinnitus Retraining Therapy)|The conventional sound therapy will be achieved with commercially available noise generators. Our clinic uses General Hearing Instruments (OHI) model Tranquil devices as noise sources for TRT. These flexible devices offer an adjustable volume control, with a frequency response extending from ~500 to 8000 Hz. Matched devices will be fitted binaurally and adjusted to each individual ear to achieve audibility of the noise sources (assessed by slight threshold shifts. typically 10- 15 dB, across the audiometric frequency range above 500 Hz). The sound pressure level output and frequency response of each noise source will be measured and documented using both real ear and standard electroacoustic methodologies. Each subject will be carefully instructed as to care of the instruments and correct volume setting. The bilateral noise generators will be used chronically during the intervention period except during sleep.
16266576|NCT00890526|Other|Counseling (Tinnitus Retraining Therapy)|The directive counseling to be used will include an in-depth participatory discussion with the patient to review audiometric and functional test results, along with the anatomy and physiology of the auditory system. A minimum of two hours will be scheduled to impart this information to the patients so that they will have a clear understanding of the disorder based upon the most current scientific data. The counseling will be focused on educating the patient, neutralizing their negative emotional association with the hyperacusis, and discussing their treatment.
16266577|NCT00890526|Other|No Counseling|Patients who are enrolled in Arms 3 and 4 of this study will not be offered directive counseling, but will be fitted with either conventional or placebo noise generators for their sound therapy components. These patients will be told only that their treatment for hyperacusis uses sound therapy. Otherwise, in the instrument fitting appointment (either for the conventional instrument or the placebo device), these patients will receive the same instruction in the care and use of sound generators as those patients enrolled in Treatment Arms 1 and 2 of the clinical trial.
16266656|NCT00889850|Drug|INexium 40 mg MUPS tablets (AstraZeneca, France)|40 mg esomeprazole, oral single dose administration under fasted and fed condition
16266657|NCT00889837|Drug|Inhaled Loxapine|Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
16266578|NCT00890526|Other|Placebo Sound Therapy|The placebo sound therapy will use factory-modified GHI Tranquil noise generators, which will appear identical to the conventional Tranquil devices. The placebo Tranquil devices will have a control sensor installed to detect insertion of the device in the ear canal. When the sensor detects the insertion of the placebo device into the ear canal it will trigger gradual decay of the sound output from the placebo device, The time constant of the decaying noise output will be sufficiently long to allow the clinician time to set the volume of each binaural set of devices and to instruct the patient in their use before any noticeable sound attenuation occurs.
16266579|NCT00890500|Drug|Fludarabine|30mg/m2/day IV x 6 days
16266580|NCT00890500|Drug|Melphalan|100 mg/m2/day IV x 1 day
16266581|NCT00890500|Drug|Antithymocyte Globulin|1mg/kg/day x 4 days
16266582|NCT00890500|Drug|Sirolimus|GVHD Prophylaxis: Target range 3-12 ng/ml
16266583|NCT00890500|Drug|Tacrolimus|GVHD Prophylaxis: Target range 5-10 ng/ml
16266584|NCT00890487|Other|hyaluronic acid pill|pill, 220 mg, once a day, three months
16266585|NCT00890474|Procedure|Moxibustion of the BL67 acupoint|Moxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version.
16266586|NCT00890461|Radiation|CT scan of the chest without contrast|Patients consenting to participate in the study may also undergo a baseline CT scan of the cest without contrast to allow for the geometrical characterization of their intracardiac electrodes from the ICD system in relation to the position of the 12-lead surface ECG electrodes which would be applied to the chest prior to the CT scan. This scan involves a small amount of radiation, a dose of approximately 1 rem. For comparison, radiation workers are permitted, by federal regulation, a maximum annual radiation exposure of 20 rems to the most sensitive organs of their body.
16266587|NCT00890448|Other|Pharmacogenomic whole blood sampling|10 mL, whole blood, one sample on Visit 2
16266588|NCT00890435|Other|questionnaire administration|
16266589|NCT00890435|Procedure|psychosocial assessment and care|
16266590|NCT00890422|Biological|FSME vaccination (FSME-Immun)|intra muscular 0.5 ml
16266591|NCT00890409|Device|Cooling cap (YJW608-04B)|A semiconductor water circulation cooling device (YJW608-04B, Henyang Radio Manufactory, Hunan, China) was used to conduct head cooling. The hypothermia group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C. All infants were nursed under a servo-controlled radiant warmer and the rectal temperature was maintained at 34.5 to 35 degree C. Head cooling was started within 6 hours after birth for 72 hours followed by spontaneous re-warming and the average time to reach the target temperature was 2 hours.
16266592|NCT00890396|Drug|Hydroxyurea|Parents and child's doctor may plan to use or not to use hydroxyurea.
16266593|NCT00890383|Drug|tetrastarch (Voluven)|Goals directed volume therapy for severe trauma resuscitation
16266594|NCT00890370|Procedure|Airway clearance technique|
16266595|NCT00890331|Behavioral|TeamWork CS Sessions|The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.
16266596|NCT00890331|Behavioral|Diabetes Education|Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments. This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
16266597|NCT00890318|Drug|ABT-072|Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
16266598|NCT00890318|Other|ketoconazole|Tablet, see Arm Description for intervention information.
16266599|NCT00890318|Drug|Placebo|Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
16266600|NCT00890305|Drug|CT-011|
16266601|NCT00890305|Drug|FOLFOX|"FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days.
~mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours)."
16266602|NCT00890292|Drug|JNJ-31001074|
16266603|NCT00890279|Drug|Cilnidipine|Cilnidipine up to 20 mg
16266604|NCT00890279|Drug|Imidapril|Imidapril up to 10 mg per day
16266605|NCT00890266|Procedure|Collagen cross-linking with hypotonic riboflavin|Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).
16266606|NCT00890253|Drug|Basiliximab (Simulect)|20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
16266607|NCT00890253|Drug|Myfortic|1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
16266608|NCT00890253|Drug|everolimus|1 mg q12 everolimus (Certican) po starting on 10th post-operative day
16266609|NCT00890253|Drug|Prednisolone|Prednisolone 1mg per kg body weight starting within 24 hours after transplantation. Then q24 but with reduction by 5 mg every 48 hours until maintenance dose of 7.5 mg
16266610|NCT00890240|Drug|JNJ-31001074|
16266611|NCT00890227|Procedure|Traditional technique|All level open instrumented posterior spinal fusions
16266612|NCT00890227|Procedure|Minimally invasive technique|Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
16266613|NCT00890214|Drug|prostacyclin|prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min
16266614|NCT00890214|Drug|heparin|was prepared using our standard protocol: 2 ml of an already-stored solution containing 5000 IU/ml of UFH were diluted in 20 ml of saline obtaining a final concentration of 500 IU/ml, and infused pre-filter at 6 IU/Kg/h, according to the post-filter activated clotting time measured hourly, and adjusted to obtain a value between 180 and 200 sec.
16266658|NCT00889837|Drug|Inhaled Placebo|Staccato Placebo, inhalations x 2 , 10 hours apart
16266659|NCT00889824|Device|balance prosthesis|vibrotactile stimulation
16266615|NCT00890201|Procedure|Gallbladder bile sampling and intraoperative cholangiography|"Interventions were exactly similar for both groups, and that is how it was intended to be:
~Gallbladder bile sampling: Sample 5 cc of gallbladder bile after the cystic duct has been clipped or ligated.
~Intraoperative cholangiography: Perform cholangiography before the cholecystectomy is finished"
16266616|NCT00890188|Drug|THALIDOMIDE and UFUR|T: Thalidomide (50): 150 mg/d ((1# tid) U: UFUR(100) 300 mg/d (1# tid) 28 days for one cycle
16266617|NCT00890175|Drug|Inhaled loxapine @ 0 & 10 h|10 mg, 2 doses, 10 hours apart
16266618|NCT00890175|Drug|Inhaled placebo @ 2 & 10 hours|placebo, 2 doses, 10 hours apart
16266619|NCT00890162|Drug|Epinephrine|
16266620|NCT00890162|Drug|Omalizumab (Xolair)|
16266621|NCT00890162|Drug|Placebos|
16266622|NCT00890149|Drug|Ondansetron|Ondansetron (4ug/kg bid),
16266623|NCT00890149|Drug|Placebo|Placebo bid
16266624|NCT00890149|Behavioral|BASICS Plus|Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking provided to both drug and placebo groups.
16266625|NCT00890123|Dietary Supplement|Omegaven-IV FO|Will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
16266626|NCT00890110|Biological|Autologous renal cell vaccine based on DNP modified cells|Primary or metastatic tumor resected in an Israeli hospital will be used to derive autologous cell lines used for vaccinations following DNP modifications in combination with the regular Sunitinib treatments. Immunological and clinical followup of the patients will be performed
16266627|NCT00890097|Drug|AL-8309B Ophthalmic Solution|
16266628|NCT00890097|Drug|AL-8309B Vehicle|Inactive ingredients used as placebo comparator
16266629|NCT00890084|Drug|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg
16266630|NCT00890071|Other|Fluid administration|500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes
16266631|NCT00890045|Device|HeRO Vascular Access Device|HeRO Vascular Access Device
16266632|NCT00890045|Device|Conventional ePTFE hemodialysis graft|Conventional ePTFE hemodialysis graft
16266633|NCT00890032|Biological|BTSC mRNA-loaded DCs|An escalating total dose of BTSC mRNA-loaded DCs (2x10^6, 5x10^6, and 2x10^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).
16266634|NCT00890019|Biological|AdCh63 ME-TRAP|"A:Intradermal injection 1x10^8 vp at day 0
~A:Intradermal injection 1x10^9 vp at day 0
~A:Intradermal injection 1x10^10 vp at day 0
~A:Intradermal injection 5x10^10 vp at day 0
~5:Intramuscular injection 1x10^10 vp at day 0
~6A:Intramuscular injection 5x10^10 vp at day 0
~7A: Intramuscular injection 2x10^11 vp at day 0"
16266635|NCT00890019|Biological|AdCh63 ME-TRAP; MVA ME-TRAP|"B: AdCh63 ME-TRAP intradermally at dose of 1x10^8 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
~B: AdCh63 ME-TRAP intradermally at dose of 1x10^9 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
~B: AdCh63 ME-TRAP intradermally at dose of 1x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
~B: AdCh63 ME-TRAP intradermally at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
~6B: AdCh63 ME-TRAP intramuscularly at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
~7B and 7C: AdCh63 ME-TRAP intramuscularly at dose of 2x10^11 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)"
16266636|NCT00890006|Procedure|Advanced imaging for radiotherapy planning and guidance|Integration of MRI in the treatment planning process / Integration of daily cone-beam computed tomography (CBCT)
16266637|NCT00889993|Dietary Supplement|Mixed Fiber Supplement|Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
16266638|NCT00889980|Other|Biospecimen banking|SLN and one non-SLN (8mm and larger in longest dimension). fourteen 10cc tubes or a total of 140mL of blood will be collected from subjects weighing over 102.6 pounds. If the subject weighs less than 102.6 pounds, the amount of blood drawn will be based on exact body weight. The amount of blood drawn will be no more than 3mL/kg of body weight.
16266639|NCT00889967|Drug|Ciprofloxacin for Inhalation|100 mg once daily by inhalation for 28 days
16266640|NCT00889967|Drug|Ciprofloxacin for Inhalation|150 mg once daily by inhalation for 28 days
16266641|NCT00889967|Drug|Placebo|Placebo once daily by inhalation for 28 days
16266642|NCT00889954|Biological|TGFBeta resistant HER2/EBV-CTLs|"Each patient will receive one injection of the TGFBeta resistant HER2/EBV-specific CTLs. Each pt will be followed for 6 weeks after the CTL infusion for evaluation of dose limiting toxicity (DLT).
~Patients may receive up to six additional doses of the T cells at 6 to 12 weeks intervals."
16266643|NCT00889941|Procedure|LASIK|laser-assisted in situ keratomileusis
16266644|NCT00889928|Device|NOTES GEN 1 Toolbox|"Articulating Hook Knife
~Articulating Snare
~Articulating Needle Knife
~Articulating Graspers
~Articulating Biopsy Forceps
~Steerable Flex Trocar with Rotary Access Needle
~Flexible Bipolar Hemostasis Forceps
~Flexible Maryland Dissector"
16266645|NCT00889915|Drug|Methylphenidate transdermal system|Not specified in protocol; determined by local standard of care.
16266646|NCT00889915|Drug|Lisdexamfetamine dimesylate|Not specified in protocol; determined by local standard of care.
16266647|NCT00889915|Drug|Osmotic-release oral system methylphenidate (OROS MPH)|Not specified in protocol; determined by local standard of care.
16266648|NCT00889915|Drug|Mixed amphetamine salts extended release|Not specified in protocol; determined by local standard of care.
16266649|NCT00889889|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine|surface antigen, inactivated, prepared in cell cultures
16266650|NCT00889889|Biological|Placebo|Placebo
16266651|NCT00889876|Drug|Metformin group|2000 mg/day for one year
16266652|NCT00889876|Behavioral|Exercise|3 times/week with a personal coach for one year. Endurance training.
16266653|NCT00889863|Drug|canakinumab|Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.
16266654|NCT00889863|Drug|placebo|Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
16266655|NCT00889850|Drug|40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)|40 mg esomeprazole, single dose administration under fasted and fed condition
16266705|NCT00889382|Drug|OSI-906|Administered orally
16266660|NCT00889811|Procedure|remote ischemic preconditioning|remote ischemic preconditioning (4 x 5 min lower limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis )
16266661|NCT00889785|Behavioral|Comprehensive intervention (disease management program)|The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component.
16266662|NCT00889785|Behavioral|Usual Care|Will receive usual care and monthly phone calls as an active control.
16266663|NCT00889733|Drug|Intraperitoneal (IP) Cisplatin|For patients who have had neoadjuvant chemotherapy followed by optimal debulking surgery they go on to receive combined IP Cisplatin and IV Paclitaxel.
16266664|NCT00889720|Drug|Varenicline|Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd
16266665|NCT00889707|Drug|PRX302|PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.
16266666|NCT00889707|Drug|Placebo|PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.
16266667|NCT00889694|Drug|Tripterygium|Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
16266668|NCT00889694|Drug|Sulfasalazine|Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
16266669|NCT00889694|Drug|placebo|Placebo: 2 capsules per time, 3 times per day for 12 weeks.
16266670|NCT00889681|Device|Arctic Front Cardiac Cryoablation System|The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
16266671|NCT00889668|Device|GlucoTrack|comparison of different glucose monitoring devices
16266672|NCT00889655|Drug|Golytely (polyethylene glycol)|4 L of golytely, in split dosing. If the patient has a morning colonoscopy, they will take 2 L of golytely over 2 hours the morning prior to their procedure and repeat this at 6 pm the night prior to their procedure.
16266673|NCT00889655|Drug|MiraLax (polyethylene glycol 3350)|238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.
16266674|NCT00889642|Device|Iontophoretic Drug Delivery System with Lidocaine/Epinephrine|Active- 10.5% Lidocaine/0.179% Epinephrine
16266675|NCT00889642|Device|Iontophoretic Drug Delivery System with Epinephrine|Placebo- 0.179% Epinephrine
16266676|NCT00889629|Drug|Doxercalciferol|Active group receives doxercalciferol (Hectorol) 1mcg
16266677|NCT00889629|Drug|placebo|Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
16266678|NCT00889629|Drug|25-OH Vitamin D3|All groups received cholecalciferol
16266679|NCT00889616|Drug|BSAM2/Alhydrogel + CPG 7909|
16266680|NCT00889603|Drug|Aricept® Evess|"5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets.
~Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing)."
16266681|NCT00889590|Drug|Zoledronic acid|4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
16266682|NCT00889564|Device|HeRO Vascular Access Device|Long-term subcutaneous vascular access device for hemodialysis
16266683|NCT00889538|Drug|placebo|50 mL of 1/2 normal saline IV
16266684|NCT00889538|Drug|glutathione|glutathione 600 mg IV
16266685|NCT00889538|Drug|glutathione, vit C and NAC|Glutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL
16266686|NCT00889525|Drug|Cabergoline|Dose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study.
16266687|NCT00889512|Drug|Luveris fixed dose|Luveris 75IU daily throughout ovarian stimulation
16266688|NCT00889512|Drug|Luveris increasing dose|Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
16266689|NCT00889499|Drug|Tropisetron 2 mg|Antagonist of the 5HT3 receptor.
16266690|NCT00889499|Drug|Tropisetron 5mg|Antagonist of the 5HT3 receptor.
16266691|NCT00889499|Drug|Placebo|NHCL 0,9%
16266692|NCT00889486|Drug|TZP-102|
16266693|NCT00889486|Drug|Placebo|
16266694|NCT00889473|Drug|Larazotide acetate|gelatin capsule
16266695|NCT00889473|Drug|Placebo|gelatin capsule
16266696|NCT00889473|Dietary Supplement|Gluten 900 mg|gelatin capsule
16266697|NCT00889460|Biological|rBet v 1|Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.
16266698|NCT00889460|Biological|Placebo|Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
16266699|NCT00889434|Dietary Supplement|ECGC|1 cycle will comprise 28 days of continuous daily treatment with EGCG given once/day(total 375 mg) /day in the morning with food followed by a 14 day wash out period without drug.
16266700|NCT00889434|Dietary Supplement|Tocotrienol|One cycle will comprise 28 days of continuous daily treatment with Tocotrienol given 2 times/6 soft gel capsules (total 600 mg) /day (BID) in the morning and in the evening with food followed by a 14 day wash out period without drug.
16266701|NCT00889434|Dietary Supplement|EGCG + Tocotrienol|combination of both arms 375 mg EGCG + 600mg/day Tocotrienol
16266702|NCT00889421|Drug|Apremilast|oral dose of 30 mg BID for 6 months
16266703|NCT00889408|Biological|DT2219ARL|anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL
16266704|NCT00889395|Behavioral|MISC training for primary caregivers|Caregivers of children in the intervention arm will undergo a year long training in MISC
16266707|NCT00889369|Drug|Duloxetine|Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility
16266708|NCT00889356|Drug|Clindamycin 100mg and Ketoconazole 400mg|1 vaginal capsule once a day at night
16266709|NCT00889356|Drug|Tetracycline 100mg and Amphotericin B 50mg|One full applicator, once a day at night
16266710|NCT00889343|Drug|Sorafenib|2x200 mg filmcoated tablets BID on day 2-12 of a 14-days cycle, oral
16266711|NCT00889343|Drug|Placebo|2 filmcoated tablets BID, day 2-12 of a 14-days cycle, oral
16266712|NCT00889343|Drug|Oxaliplatin or Irinotecan|Oxaliplatin 100 mg/m2 intravenous infusion on day 1 of 14-days cycle, Irinotecan 180 mg/m2 intravenous infusion on day 1 of 14-days cycle
16266713|NCT00889343|Drug|Leucovorin|400 mg/m2 intravenous infusion on day 1 of a 14-days cycle
16266714|NCT00889343|Drug|5-Fluorouracil|400 mg/m2 intravenous bolus infusion on day 1, 2400 mg/m2 46 hour intravenous infusion on day 1 to 2 of a 14-days cycle
16266715|NCT00889330|Drug|alcaftadine|0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
16266716|NCT00889330|Drug|Placebo|Vehicle without active, one drop in each eye at each of two visits.
16266717|NCT00889317|Device|fmri (functional magnetic resonance imaging)|functional image acquisition (75mn) anatomical image acquisition (15mn)
16266718|NCT00889304|Device|Position HTO system|open wedge high tibial osteotomy
16266719|NCT00889265|Device|CopiOs Pericardium Membrane|CopiOs Pericardium, Puros Cancellous
16266720|NCT00889252|Device|contact lens with ketotifen|K-Lens (generic name not established) and Ketotifen combination drug-device product
16266721|NCT00889252|Device|contact lens|Placebo contact lens
16266722|NCT00889239|Other|lithia-disilicate-based crown|all-ceramic crown
16266723|NCT00889226|Drug|Pitavastatin|Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
16266724|NCT00889226|Drug|Atorvastatin|Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
16266725|NCT00889213|Procedure|Falciform patch and fibrin glue application|Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. Those patients randomized to autologous falciform patch will have the falciform membrane harvested. The falciform patch will be laid over the suture line of the resected pancreatic stump and secured to the pancreatic capsule utilizing #4-0 PDS suture placed at 12, 3, 6, and 9 o'clock positions. Fibrin glue (Vitagel) will be utilized to fill the potential space within this membranous capsule. Fibrin glue will be prepared as per standard instructions. Drains will be placed in the splenic bed and/or adjacent to the stump of the pancreas for postoperative fluid evacuation.
16266726|NCT00889213|Procedure|standard pancreatic closure|Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament.
16266727|NCT00889200|Drug|eszopiclone|6 weeks standard oral therapy
16266728|NCT00889187|Radiation|Neoadjuvant Short-Course Photon Radiation|
16266729|NCT00889187|Drug|Capecitabine|
16266730|NCT00889161|Drug|Curcumin|Initial dosage of 500mg twice a day for 3 weeks. Using the forced dose titration design, dose will be titrated up to 1g twice a day at Week 3 for a total of three weeks and then titrated again to 2g twice a day at Week 6 for three weeks.
16266731|NCT00889148|Drug|Gabapentin|600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
16266732|NCT00889148|Other|Placebo|Half the patients will be randomized to placebo
16266733|NCT00889135|Drug|droxidopa|Droxidopa (L-DOPS) comes in capsule form, 100 mg or 200 mg strength and is usually administered 2 - 3 times per day. It would be taken indefinitely to improve symptoms of orthostatic hypotension
16266734|NCT00889122|Behavioral|Exergame (DDR)|Use of an active videogame vs. pedometers given to entire families to promote physical activity.
16266735|NCT00889109|Other|Three dimensional unrestricted arm movements|The subjects will carry out three dimensional unrestricted arm movements. The subjects' movements will be recorded by optoelectronic infrared cameras and software. Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception.
16266736|NCT00889096|Drug|propranolol|Oral administration of 80 mg propranolol (1 gelatine capsules; content: 2 tablets of Obsidan® 40 mg Tablets) or placebo (1 gelatine capsules; content: 1 tablet placebo; microcrystalline cellulose, magnesium stearate, cellulose powder, lactose monohydrate) according to randomization list with 240 ml tap water.
16266737|NCT00889096|Drug|placebo|Oral administration of placebo (1 gelatine capsules; content: 1 tablet placebo; microcrystalline cellulose, magnesium stearate, cellulose powder, lactose monohydrate) according to randomization list with 240 ml tap water.
16266738|NCT00889057|Drug|sorafenib|400 mg bid until progression or inacceptable toxicity
16266739|NCT00889044|Drug|clopidogrel by chewing|600 mg clopidogrel by chewing
16266740|NCT00889044|Drug|Placebo|Placebo p.o
16266741|NCT00889031|Other|No Intervention|Patients with Chronic Lymphocytic Leukemia (CLL)
16266742|NCT00889018|Drug|carboplatin|Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 560 mg/m2 (18.6 mg/kg for children £36 months old). .
16266743|NCT00889018|Drug|carboplatin|Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 750 mg/m2 (25 mg/kg for children £36 months old).
16266744|NCT00889005|Other|Telephone Based Cognitive Behavioral Therapy|Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
16266745|NCT00888992|Behavioral|Quitline Service + 10 automated monitoring calls|This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 10 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be two calls per a week for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
16266746|NCT00888992|Behavioral|Quitline service + 20 automated monitoring calls|This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 20 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be one automated call a day for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
16266747|NCT00888979|Drug|Nicotrol Inhaler|10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
16266748|NCT00888953|Other|Fall risk assessment|Assessment of presence of risk factors (previous falls, self efficacy, balance and gait disorders, weakness, daily living impairment, limb pain, foot problems, dizziness, cognitive impairment, vision impairment, depression, urinary incontinence, heart disease, polimedication and consumption of neuroleptics and psychotropic medication)
16266749|NCT00888953|Other|Tailored intervention|Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.
16266750|NCT00888940|Drug|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
16266751|NCT00888940|Drug|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
16266752|NCT00888927|Biological|KW-0761|The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. Succeeding dose levels will include 0.3 and 1 mg/kg. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
16266753|NCT00888914|Drug|RT001|RT001
16266754|NCT00888914|Drug|RT001|RT001
16266755|NCT00888914|Drug|RT001|RT001
16266756|NCT00888914|Drug|RT001|RT001
16266757|NCT00888914|Other|Vehicle Comparator|Vehicle Comparator
16266758|NCT00888901|Drug|eltrombopag|eltrombopag tablets daily, in increasing dosage, for three months
16266759|NCT00888901|Drug|corticosteroids (Aprednislon)|corticosteroids in decreasing dosage
16266760|NCT00888888|Procedure|Right hemicolectomy with or without primary anastomosis|During open classic appendectomy (McBurney incision) the surgeon decided to convert to midline extended laparotomy to perform a right hemicolectomy
16266761|NCT00888875|Device|i-gel|insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically
16266762|NCT00888875|Device|ILMA|Insertion after Induction. Insertion of tracheal tube over device
16266763|NCT00888862|Drug|Desvenlafaxine Succinate|Desvenlafaxine Succinate, 50-100mg/day for 8 weeks
16266764|NCT00888849|Procedure|Advant 55 Linear Cutter/Stapler|Advant 55 Linear Cutter/Stapler
16266765|NCT00888849|Procedure|Suturing|Suturing
16266766|NCT00888836|Procedure|Bariatric surgery: Gastric bypass|Gastric bypass (GBP): A subcardial gastric pouch with a 30±10 ml capacity will be created on a naso-gastric 36F calibrating tube by sectioning the stomach with a linear stapler 3-4 cm horizontally on the lesser curve, 4 cm distal to the e-g junction, and then vertically until attainment of the angle of Hiss. After identification of the Treitz ligament, the jejunum will be transected at 100 cm from the ligament of Treitz and the two stumps will be closed. The distal stump will be anastomosed to the distal end of the gastric pouch. The preferred gastro-jejunal anastomosis is the totally hand-sewn one, but it can be performed using any other the technique the surgeon is more familiar with. Finally, the proximal stump of the transacted bowel will be joined end-to-side to the jejunum 150 cm distal to the gastroenterostomy.
16266767|NCT00888836|Procedure|Bariatric surgery: Bilio-pancreatic diversion|Biliopancreatic diversion (BPD): A distal two-third gastrectomy will be carried out aiming at leaving an about 400 ml gastric remnant. The gastrointestinal continuity will be re-established by sectioning the small bowel 300 cm proximal to the ileocecal valve, closing the intestinal stumps, and joining the proximal one end-to-side to the distal ileum at 50 cm from the ligament of Treitz. The distal stump of the transacted bowel will be anastomosed to the left corner of the gastric stump, preferably in a totally hand-sewn fashion.
16266768|NCT00888836|Behavioral|anti-diabetic drugs and behavioral suggestions|Medical therapies (oral hypoglycemic agents and insulin) are optimized on an individual basis. Lifestyle modification programs, including reduced energy and fat (<30% total fat and <10% saturated fat, high fibre content) intake and increased physical exercise (suggested at least 30 minutes of brisk walking every day possibly associated with a moderate intensity aerobic activity twice a week), are tailor made by an experienced diabetologist assisted by a dietitian. After the two years, the patients in control group will be offered the choice to undergo one of the two surgical procedures.
16266769|NCT00888823|Radiation|Stereotactic Radiotherapy|Stereotactic Radiotherapy
16266770|NCT00888810|Drug|TOPOTECAN|IV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles)
16266771|NCT00888810|Drug|LAPATINIB|Daily oral administration during all the study. 1250 mg/day
16266772|NCT00888797|Drug|Propranolol and Etodolac|Both study medications will be given orally for an intervention phase of 20 days as follows: 5 days prior to surgery, on the day of surgery, and 14 days postoperatively. Etodolac:800 mg PO bid for the entire intervention period,Propranolol:20 mg PO bid for 5 preoperative days, 80 mg PO bid on the day of surgery, 40 mg PO bid for the first postoperative week, 20 mg PO bid for the second postoperative week.
16266773|NCT00888784|Procedure|Endoscopic Cyanoacrylate injection|Endoscopic Cyanoacrylate injection in gastric varix
16266815|NCT00888472|Procedure|Leukocytapheresis|5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.
16266816|NCT00888459|Drug|nicotine replacement therapy|4 mg nicotine lozenges, ad lib, for 12 weeks.
16266774|NCT00888784|Drug|beta-blocker (propranolol)|Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
16266775|NCT00888758|Device|biolimus A9|200 patients with STEMI will be treated using Biomatrix stent.
16266776|NCT00888758|Device|everolimus|200 patients with STEMI will be treated with PROMUS DES.
16266777|NCT00888745|Drug|placebo|Intravenous and subcutaneous ascending dose
16266778|NCT00888745|Drug|PRO283698|Intravenous and subcutaneous ascending dose
16266779|NCT00888732|Drug|Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin|0.2 U/IU/kg subcutaneous injection, single dose
16266780|NCT00888719|Drug|CWP-0403 100mg|100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
16266781|NCT00888719|Drug|placebo|"Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
~Twice a day, 1 tablet at a time for 12 weeks"
16266782|NCT00888719|Drug|CWP-0403 50mg|50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
16266783|NCT00888706|Behavioral|Control Condition|The group participated in the usual nursing home activities and routines.
16266784|NCT00888706|Behavioral|Individualized Social Activities (ISA)|The group received individualized social activities one hour daily, during usual brief daytime napping episodes, between 9 am to 5 pm in brief 15-30 minute intervals five days a week.
16266785|NCT00888706|Behavioral|Physical Resistance Training and Walking (PRT/walking)|The group participated in high intensity PRT to the hip and arm extensors (three sets of eight repetitions per muscle per group, approximately 40 minutes) plus 10 minutes of warm-up and 10 minutes of cool-down on Monday, Wednesday and Friday afternoons for one hour (between 2-5pm). On Tuesdays and Thursdays, participants walked with a research assistant for as long as the participant could walk for up to 60 minutes.
16266786|NCT00888706|Behavioral|Combined ISA/PRT/walking|The group had one hour of ISA in the morning or afternoon and one hour of PRT/walking in the afternoon from 2-5pm five days a week. This group received interventions for 2 hours per day.
16266787|NCT00888693|Drug|ABT-288|See Arm Description for details.
16266788|NCT00888693|Drug|Placebo|See Arm Description for details.
16266789|NCT00888680|Drug|BGC20-1531|BGC20-1531 administered orally
16266790|NCT00888680|Drug|Lactose|Placebo administered orally
16266791|NCT00888667|Other|Pacing interventions|10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting
16266792|NCT00888654|Drug|B-Dim|B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
16266793|NCT00888654|Procedure|Radical Prosatectomy|
16266794|NCT00888641|Procedure|Hypothermia|Surround kidney in ice slush for 10 minutes after arterial clamping
16266795|NCT00888628|Biological|Purified Pancreatic Islets|Islet after kidney transplant in patients with type I diabetes.
16266796|NCT00888628|Drug|Etanercept|Given as induction for islet cell transplant
16266799|NCT00888602|Dietary Supplement|3.4 g psyllium|3.4 g psyllium served with meal
16266800|NCT00888602|Dietary Supplement|6.8 g psyllium|6.8 g psyllium served with a meal
16266801|NCT00888602|Dietary Supplement|6.8 g psyllium|6.8 g psyllium
16266802|NCT00888602|Other|Meal|meal
16266803|NCT00888550|Procedure|Post-Op Splinting|Splint will applied post-operatively and will remain on for two weeks
16266804|NCT00888550|Procedure|No Splinting|Patient will be discharged post-operatively without a splint on their lower leg.
16266805|NCT00888537|Other|AMI Choice Decision Aid|The decision aid describes the risk of dying in the first six months following a heart attack without and with taking a bundle of medications to help the heart heal.
16266806|NCT00888537|Other|Usual Care|Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
16266807|NCT00888524|Procedure|GP in Physio|manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment
16266808|NCT00888524|Procedure|GP in Physio plus DWR|GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
16266809|NCT00888511|Drug|Tarceva|Tarceva 150 mg/day
16266810|NCT00888511|Radiation|Radiotherapy|66 Gy/33 F/5 F per week for 5 weeks
16266811|NCT00888498|Other|Passive Positioning|With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.
16266812|NCT00888498|Other|High-Velocity, Low-Amplitude Stretch|With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.
16266813|NCT00888498|Other|Slow, Mobilization Stretch|With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.
16266814|NCT00888485|Behavioral|Behavioral interventional program|Cognitive behavioral therapy intervention adapted to coronary disease patients performed in 20 group sessions during one year.
16266817|NCT00888459|Drug|placebo NRT|Placebo nicotine lozenges
16266821|NCT00888446|Other|Formulation buffer|Sterile isotonic buffered salt solution
16266822|NCT00888433|Device|Renal Denervation (Symplicity® Renal Denervation System)|Catheter-based renal denervation
16266823|NCT00888420|Other|Performance Improvement Measures|PDSA (Plan, Do, Study, Act) performance improvement measures
16266824|NCT00888407|Behavioral|HBV Screening - Small group educational session|Small group HBV focused discussion with HBV screening resources.
16266825|NCT00888407|Behavioral|Nutrition - Small group educational session|Small group session with diet & nutrition focused, topic related resources provided.
16266826|NCT00888394|Procedure|chiropody|basic procedure of chiropody in podiatry
16266827|NCT00888394|Procedure|basic orthesis|individual basic orthesis of foot
16266828|NCT00888394|Procedure|advantage orthesis|advantage orthesis of foot with special material and design
16266829|NCT00888394|Procedure|chiropody and advantage orthesis|chiropody and advantage orthesis of foot
16266830|NCT00888381|Biological|Inactivated Influenza Vaccine (2009 / 2010 formulation)|A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
16266831|NCT00888368|Procedure|Transpatellar Approach|The transpateller approach for the injection of the dye will be used.
16266832|NCT00888368|Procedure|Suprapatellar|The suprapatellar approach will be used for the injection of the dye.
16266833|NCT00888355|Drug|losartan potassium|losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
16266834|NCT00888355|Drug|Comparator: placebo|placebo to losartan tablet q.a.m. , for 12 weeks
16266835|NCT00888342|Drug|supplementary oxygen|Supplementary oxygen 2 L/min if SpO2 < 90%. If SpO2 < 90 % the oxygen dose is titrated until SpO2 reads 88-92%. For patients on LTOT the oxygen dose is doubled for intervention.
16266836|NCT00888342|Drug|zopiclone|5 mg sedative given approximately 1 hour before sleep
16266837|NCT00888342|Other|alcohol|5 mg alcohol/kg body-weight approximately 1 hour before sleep
16266838|NCT00888329|Drug|Aprepitant|40 mg administered orally with a sip of water prior to anesthesia induction.
16266839|NCT00888329|Drug|Placebo|Placebo
16266840|NCT00888316|Procedure|magnetic resonance imaging|"MRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date.
~The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC."
16266841|NCT00888316|Procedure|Serum ferritin|Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
16266842|NCT00888303|Drug|Dexamethasone|20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
16266843|NCT00888303|Drug|saline solution|20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
16266844|NCT00888303|Procedure|Thyroidectomy, total or partial|Surgical standard intervention
16266845|NCT00888290|Drug|Sodium bicarbonate|Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight
16266846|NCT00888251|Other|Comprehensive weight management program|Full meal replacement, behaviorial modification, medical monitoring, exercise.
16266847|NCT00888238|Drug|sitagliptin|Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
16266848|NCT00888238|Drug|Comparator: Placebo|Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
16266849|NCT00888225|Procedure|Eccentric exercise|Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
16266850|NCT00888225|Procedure|Concentric exercise|Concentric exercise treatment at home with three sets of 15 repetitions daily
16266851|NCT00888212|Procedure|Bronchoscopy|Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy
16266852|NCT00888199|Device|Experimental prosthetic foot (K3 Promoter)|Experimental prosthetic foot
16266853|NCT00888186|Drug|levodopa/carbidopa|intestinal gel, for continuous daytime infusion
16266854|NCT00888173|Drug|Brivanib Alaninate|Given PO
16266855|NCT00888173|Other|Laboratory Biomarker Analysis|Correlative studies
16266856|NCT00888147|Dietary Supplement|Fiber containing tube feeding formula|This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.
16266857|NCT00888134|Drug|Selumetinib|Given PO
16266858|NCT00888108|Drug|ABT-263|150 mg of ABT-263 is taken orally once daily on Days 1-5 or Days 1-3 of each 21 day cycle. 150 mg of ABT-263 on Days 1-3, 8-10 and 15-17 of each 28-day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
16266859|NCT00888108|Drug|Docetaxel|75 mg/m2 will be given by intravenous infusion on day 1 of each 21 -day cycle. 30 mg/m2 will be given by intravenous infusion on day 1, 8, 15 of each 28 -day cycle.
16266860|NCT00888095|Procedure|deep brain stimulation|electrode implantation in either STN or cZI
16266861|NCT00888082|Drug|Goserelin acetate|3.6 mg depot injectable preparation
16266862|NCT00888069|Drug|CTAP101 Capsules|Single dose oral administration
16266863|NCT00888069|Drug|CTAP101 Injection|single IV injection
16266864|NCT00888056|Procedure|Bilateral chronic electrical stimulation of the hypothalamus/fornix|Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, under local anesthesia, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, before its entry in the mamillary body (well defined on T2 weighted sequences). Intra-operative stimulation will be used to search adverse effects or acute effects. Electrodes will be connected to the generator (Kinetra, Medtronic) under general anesthesia. Chronic high-frequency stimulation will be delivered immediately after surgery.
16266906|NCT00887653|Drug|raltegravir|This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
16266865|NCT00888043|Drug|CNTO 95 and avastin|"STAGE 1 (Dose escalation) Cohort # subjects CNTO 95 Bevacizumab
~2 3-6 2.5 mg/kg IV Q3 weeks 7.5 mg/kg IV Q3 weeks
~1 3-6 2.5 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks
~3-6 5 mg/kg IV Q3weeks 15 mg/kg IV Q3 weeks
~3-6 10 mg/kg IV Q3 weeks 15 mg/kg IV Q3 weeks STAGE 2 (Biomarker) Cohort # subjects CNTO 95 Bevacizumab
~20 Recommended Phase II Dose Recommended Phase II Dose"
16266866|NCT00888030|Other|there are no interventions currently listed for this study|
16266867|NCT00888004|Drug|AFQ056|
16266868|NCT00888004|Drug|Placebo|
16266869|NCT00887978|Drug|UT-15C SR|treprostinil diolamine sustained release tablets
16266870|NCT00887978|Drug|Placebo|
16266871|NCT00887965|Drug|Previous denosumab|Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
16266872|NCT00887952|Procedure|Partial removal of carious dentine|All procedures will be carrying out under local anesthesia and rubber dam. The treatment will be performed as follow: access to the lesion using rotator instruments (if necessary); fully removal of carious tissue from the cavity walls according to hardness criteria by rotator instruments and/or hand excavator; removal of the necrotic carious tissue (soft and disorganized carious tissue) from the cavity floor by hand excavator (to avoid pulp exposure); cleaning with distilled water and drying with sterile filter paper; group randomization. If the tooth is assigned to test group: cavity floor covered with calcium hydroxide cement; restoration using amalgam or steel crown following their usual clinical procedures based on the instructions of the manufacturer
16266873|NCT00887952|Procedure|Stepwise excavation|The treatment will be performed as follow: access to the lesion using rotator instruments (if necessary); fully removal of carious tissue from the cavity walls according to hardness criteria by rotator instruments and/or hand excavator; removal of the necrotic carious tissue (soft and disorganized carious tissue) from the cavity floor by hand excavator (to avoid pulp exposure); cleaning with distilled water and drying with sterile filter paper; group randomization. If the tooth is assigned to SE: indirect pulp capping with calcium hydroxide cement; temporary filling with IRM; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling following the same procedures described to test group.
16266874|NCT00887926|Biological|IMC-EB10|Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle
16266875|NCT00887913|Device|Fractional RF treatment with Matrix RF applicator|3 treatments, single pass, 2-50J
16266876|NCT00887900|Procedure|Deep anterior lamellar keratoplasty (DALK)|Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
16266877|NCT00887900|Procedure|Penetrated keratoplasty|Regular corneal transplant using the penetrated keratoplasty technique
16266878|NCT00887874|Other|No treatment given|Subject will only fill out a questionaire when entering the observational study.
16266879|NCT00887861|Drug|Investigational new drug, company code: BGG492|
16266880|NCT00887861|Drug|Placebo|
16266881|NCT00887848|Other|Lokomat training|15 sessions of Lokomat training within 5 weeks (3 trainings/week)
16266882|NCT00887835|Device|PERPOS™ PLS|To stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.
16266883|NCT00887822|Drug|Bevacizumab|7.5 mg/kg IV infusion on Day 1 of every 3-week cycle
16266884|NCT00887822|Drug|Placebo|Placebo matched to bevacizumab on Day 1 of every 3-week cycle
16266885|NCT00887822|Drug|Capecitabine|1000 mg/m^2 orally twice daily on Days 1-14 of every 3-week cycle
16266886|NCT00887822|Drug|Cisplatin|80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
16266887|NCT00887809|Drug|gemcitabine|
16266888|NCT00887809|Drug|docetaxel|
16266889|NCT00887809|Drug|bevacizumab|
16266890|NCT00887783|Drug|Navelbine|Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
16266891|NCT00887783|Radiation|66 Gy/33F|irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
16266892|NCT00887783|Radiation|60 Gy/30F|irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
16266893|NCT00887770|Drug|AZD5672|12 x 50mg tablet, oral, single dose
16266894|NCT00887770|Drug|Moxifloxacin|1 x 400mg capsule, oral, single dose
16266895|NCT00887770|Drug|placebo|12 x matched to AZD5672 50 mg tablet
16266896|NCT00887770|Drug|AZD5672|3 x 50mg tablet, oral. single dose
16266897|NCT00887770|Drug|placebo|9 x matched to AZD5672 50mg tablet
16266898|NCT00887770|Drug|placebo|1 x matched to Moxifloxacin capsule
16266899|NCT00887757|Drug|ABT-263|"150mg of ABT-263 is taken orally once daily on Days 1-3 and Days 8-10 out of each 21 day cycle.
~325 mg of ABT-263 is taken orally once daily on days 1-3, 8-10, 15-17 out of each 28 day cycle.
~This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study."
16266900|NCT00887757|Drug|gemcitabine|Gemcitabine 1000 mg/m2 will be given by intravenous infusion on Day 1 and Day 8 of each 21 day cycle. Gemcitabine 1000 mg/m2 will be given by intravenous infusion on days 1, 8 and 15 of each 28 day cycle.
16266901|NCT00887744|Device|Aperius® Percutaneous Interspinous Spacer|Implantation of the Aperius® device
16266902|NCT00887718|Biological|PET Scan|18F-Fluorodeoxyglucose (FDG) injection
16266903|NCT00887705|Behavioral|ADL training|The control group gets the standard rehabilitation programme which includes one hour ADL- training. The experimental group also gets the standard rehabilitation program, but instead of one hour they get an additional five hours ADL- training.
16266904|NCT00887692|Behavioral|prone and supine position|patients will be treated alternating daily between prone and supine position for breast radiotherapy.
16266905|NCT00887679|Drug|Escitalopram|10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
16266907|NCT00887640|Drug|Temsirolimus|dosage form: IV dosage, frequency and duration: 25mg weekly until clinical progression
16266908|NCT00887640|Drug|Diphenhydramine|Dosage form: IV or PO Dosage, frequency and duration: 25-50mg, 30 minutes prior to Temsirolimus infusion
16266909|NCT00887627|Drug|conivaptan hydrochloride|intravenous
16266910|NCT00887614|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
16266911|NCT00887601|Drug|MK3134|Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods.
16266912|NCT00887601|Drug|Comparator: Placebo|Placebo capsules only in one of the four treatment periods.
16266913|NCT00887601|Drug|Donepezil|Single dose 5 mg donepezil capsules in two of the four treatment periods.
16266914|NCT00887601|Drug|MK3134|Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods
16266915|NCT00887588|Drug|LCZ696|50 mg, 100 mg and 200 mg tablets
16266916|NCT00887588|Drug|Valsartan|40 mg, 80 mg and 160 mg tablets
16266917|NCT00887588|Drug|Placebo|matching placebo to LCZ696 and Valsartan
16266918|NCT00887575|Drug|Paclitaxel|IV infusion per institutional guidelines on Days 1, 8 and 15 of a 28 day cycle as follows depending on dose level (DL): DL1- 70 mg/m2, DL2- 80 mg/m2, DL3- 80mg/m2, DL4- 80mg/m2, DL-1- 70mg/m2, DL-2- 60mg/m2
16266919|NCT00887575|Drug|Carboplatin|IV infusion per institutional guidelines Day 1 of a 28 day cycle as follows depending on dose level (DL): DL1- AUC=5, DL2- AUC=5, DL3- AUC=6, DL4- AUC=6, DL-1- AUC=4, DL-2- AUC=4
16266920|NCT00887575|Drug|Sunitinib|By mouth (PO) once daily on days 1-21 of a 28 day cycle as follows depending on dose level (DL): DL1- 25mg, DL2-25mg, DL3- 25mg, DL4- 37.5mg, DL-1- 25mg, DL-2- 25mg. Maintenance therapy of 25mg daily
16266921|NCT00887562|Drug|Idebenone|900 mg/day for 1 month
16266922|NCT00887562|Drug|Idebenone|2250 mg/day for 1 month
16266923|NCT00887562|Other|Placebo|Placebo - No idebenone
16266924|NCT00887549|Drug|pemetrexed|Induction Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
16266925|NCT00887549|Drug|cisplatin|Induction Therapy: 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles
16266926|NCT00887536|Drug|bevacizumab|bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab
16266927|NCT00887536|Drug|docetaxel|docetaxel 75 mg/m2 IV every 21 days for 6 cycles
16266928|NCT00887536|Drug|doxorubicin|doxorubicin 50 mg/m2 IV every 21 days for 6 cycles
16266929|NCT00887536|Drug|cyclophosphamide|"Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
~Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles"
16266930|NCT00887536|Drug|pegfilgrastim|pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles [filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.]
16266931|NCT00887523|Behavioral|radiation in prone position|radiation in prone position
16266932|NCT00887523|Behavioral|radiation in supine position|radiation in supine position
16266933|NCT00887510|Drug|Hydrochlorothiazide|"25 mg tablet once daily for 6 weeks
~Other Names:
~HCTZ"
16266934|NCT00887510|Drug|Trandolapril|4 mg tablet once daily for 6 weeks
16266935|NCT00887497|Procedure|Angioembolization|Angioembolization
16266936|NCT00887484|Drug|BENZOYL PEROXIDE/ CLINDAMYCIN|Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
16266937|NCT00887484|Drug|BENZOYL PEROXIDE/ ADAPALENE|Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
16266938|NCT00887471|Procedure|PITA or T&A|PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy
16266939|NCT00887458|Drug|Itraconazole 200 mg|Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
16266940|NCT00887458|Drug|Itraconazole 300mg|Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
16266941|NCT00887445|Drug|SLV341|5 - 1000mg once daily
16266942|NCT00887445|Drug|placebo|
16266949|NCT00887419|Behavioral|Coping Skills Training|Patients meet individually with therapist for 6 sessions to learn coping skills for stress management, behavioral activation, and communication.
16266950|NCT00887419|Behavioral|Education|Patients meet individually with a health educator for 6 sessions in a presentation/discussion format to receive basic information on the etiology and treatment of chronic pain.
16266951|NCT00887406|Drug|GSK961081 15mcg SD|Single dose delivered via solution for nebulisation
16266952|NCT00887406|Drug|GSK961081 3mcg SD|single dose delivered via nebulsier
16266953|NCT00887406|Drug|GSK961081 50mcg SD|single dose delivered via solution for nebulisation
16266954|NCT00887406|Drug|Placebo SD|single dose via nebuliser
16266955|NCT00887406|Drug|GSK961081 100mcg SD|single dose delivered via solution for nebulisation
16266956|NCT00887406|Drug|GSK961081 200mcg SD|single dose via nebuliser
16266957|NCT00887406|Drug|GSK961081 300mcg SD|single dose via nebuliser
16266958|NCT00887406|Drug|GSK961081 100mcg RD|repeat dose via nebuliser
16266959|NCT00887406|Drug|GSK961081 300mcg RD|repeat dose vai nebuliser
16266960|NCT00887406|Drug|Placebo RD|repeat dose via nebuliser
16266961|NCT00887393|Other|low carbohydrate diet|1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake)
16266962|NCT00887393|Other|low-fat diet|1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake)
16266963|NCT00887380|Drug|Pre-radiotherapy commencement of anastrozole|Anastrozole: 1mg per day will be prescribed for 12 weeks. Commencing within 1 week of randomisation, to be administered from a min of 1 week before and a max of 4 weeks before commencement of radiotherapy and continued throughout radiotherapy. After 12 weeks administration of anastrozole according to trial regimen, anastrozole can be continued at the treating clinician's discretion and in accordance with the preference selected at the time of randomisation and stratification. The alternative options to long-term anastrozole are tamoxifen or cessation of anti-oestrogen therapy.
16266964|NCT00887380|Radiation|Radiotherapy|Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.
16266965|NCT00887380|Drug|Post radiotherapy commencement of anastrozole|Anastrozole 1mg per day will be prescribed for 12 weeks after radiotherapy is completed. Anastrozole should commence within 1 week of the last fraction of radiotherapy and be continued for a total of 12 weeks. After 12 weeks administration according to the trial regimen, any subsequent hormone therapy is as for the concurrent arm.
16266966|NCT00887367|Drug|GSK598809|Two 175 mg doses of GSK598809 will be given.
16266967|NCT00887367|Other|Ethanol|A constant ethanol level of 0.6 g·L-1 for five hours will be given to the subjects intravenously. This level shows significant CNS effects, without causing too many inadvertent events. Furthermore this level is considered safe as it is just above the legal driving limit in the Netherlands (i.e. 0.5 g·L-1) and these levels are routinely achieved during social drinking. Moreover, this level leaves enough room for CNS-impairment without compromising safety, in case of a (supra-) addictive drug-alcohol interaction.
16266968|NCT00887354|Drug|Teriparatide|Administered subcutaneously
16266969|NCT00887354|Drug|Risedronate|Administered orally
16266970|NCT00887354|Drug|Placebo|"Weekly: Administered orally
~Daily: Administered subcutaneously"
16266971|NCT00887354|Dietary Supplement|Calcium|Approximately 500 to 1000 mg/day administered orally throughout study.
16266972|NCT00887354|Dietary Supplement|Vitamin D|Approximately 800 International Units per day (IU/day) administered orally throughout study.
16266973|NCT00887341|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
16266974|NCT00887341|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration
16266975|NCT00887328|Drug|Tissue Plasminogen Activator (Alteplase)|0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
16266976|NCT00887328|Drug|Placebo|placebo provided as 50mg lyophilised powder to be reconstituted with sterile water in glass vials indistinguishable from active drug
16266977|NCT00887315|Drug|Docetaxel and cisplatin|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles
16266978|NCT00887315|Radiation|Docetaxel and cisplatin Plus Hypofractionated Radiotherapy|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease
16266979|NCT00887276|Drug|Moxifloxacin|"intravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours)
~20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes
~20 ml physiologic saline solution (placebo) (over 30 min)
~20 ml physiologic saline solution (placebo) (over 30 min)
~following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
~1 capsule Moxifloxacin (400 mg) + 1 capsule Placebo
~2 capsules Placebo
~2 capsules Placebo
~Total time of the therapy:at least 7 days, but at most 10 days"
16266980|NCT00887276|Drug|Ampicillin;Amoxicillin|"intravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours)
~2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min)
~2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
~2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
~following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
~2 capsules Amoxicillin (0,5 g)
~2 capsules Amoxicillin (0,5 g)
~2 capsules Amoxicillin (0,5 g)
~Total time of the therapy: at least 7 days, but at most 10 days"
16266981|NCT00887263|Drug|Budesonide|3 mg TID
16266982|NCT00887263|Drug|Placebo|0 mg TID
16266983|NCT00887250|Drug|losartan potassium|50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.
16266984|NCT00887250|Drug|Comparator: losartan|50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.
16266985|NCT00887250|Drug|Comparator: Placebo|Placebo to Losartan
16266986|NCT00887237|Device|CRT with triple site ventricular stimulation|CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
16266987|NCT00887237|Device|Conventional cardiac resynchronization|Conventional cardiac resynchronization
16266988|NCT00887224|Drug|Desvenlafaxine succinate sustained release 50 mg|50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.
16266989|NCT00887224|Drug|Desvenlafaxine succinate sustained release 25 mg|25 mg tablet for taper, once daily for 1 week
16266990|NCT00887224|Drug|Placebo|Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.
16266991|NCT00887211|Device|stent|ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
16266992|NCT00887211|Device|stent|Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
16266993|NCT00887198|Drug|Abiraterone acetate|1000 mg per day (4 x 250-mg tablets) taken orally.
16266994|NCT00887198|Drug|Placebo|4 placebo tablets per day taken orally.
16266995|NCT00887198|Drug|Prednisone|5 mg tablet orally twice daily.
16266996|NCT00887185|Other|Simulator training for temporal bone surgery|Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
16266997|NCT00887172|Drug|Jing Fang Bai Du san|The Jing Fang Bai Du san can relieve external symptoms and effectively clear up the pathogenic cold. It contains 13 herbs including, Radix Angelicae Pubescentis, Radix Peucedani, Radix Ginseng, Smilacis Glabrae Rhizoma, Rhizoma Chuanxiong, Fructus Aurantii, Radix Platycodi, GlycyrrhizaeRadix, Herba Schizonepetae, Fructus Arctii, MenthaeFolium, Radix Saposhnikoviae, Rhizoma et Radix Notopterygii.The CHM preparations were manufactured and supplied by Pura Pharm International (H.K.) Ltd., in the form of concentrated granules which follows the GMP standard. None of the herbs in these two formulas are included in the Toxic Chinese Herbal Medicine List of the Chinese Medicine Ordinance Schedule 1 or being a controlled substance, animal product, or endangered species.
16266998|NCT00887172|Drug|Placebo|The sachets of the CHM formulae and placebo were identical in appearance except for the randomization numbers. The placebo contains Maltose-dextrine granules that are identical in weight, appearance, flavour and texture as the CHM granules. Both the Chinese medicine practitioner who assessed the subjects and the subjects were blinded to the nature of the treatment. The pharmaceutical supplier kept the medication and placebo codes, which were broken at the end of the study after completion of all the assessment and data analyses.
16266999|NCT00887172|Drug|Ying Qiao san|The Ying Qiao san can relieve external symptoms and effectively clear up the pathogenic heat. It contains 10 herbs: Fructus Forsythiae, LoniceraeFlos, Radix Platycodi, MenthaeFolium, GlycyrrhizaeRadix, Herba Schizonepetae, Sojae Semen praeparatum, Fructus Arctii, PhragmitisRhizoma and LophatheriHerba. The CHM preparations were manufactured and supplied by Pura Pharm International (H.K.) Ltd., in the form of concentrated granules which follows the GMP standard. None of the herbs in these two formulas are included in the Toxic Chinese Herbal Medicine List of the Chinese Medicine Ordinance Schedule 1 or being a controlled substance, animal product, or endangered species.
16267000|NCT00887159|Drug|Cisplatin|Given IV
16267001|NCT00887159|Biological|Cixutumumab|Given IV
16267002|NCT00887159|Drug|Etoposide|Given IV
16267003|NCT00887159|Other|Laboratory Biomarker Analysis|Correlative studies
16267004|NCT00887159|Drug|Vismodegib|Given PO
16267005|NCT00887146|Drug|concomitant temozolomide (TMZ)|75 mg/m^2, orally daily
16267006|NCT00887146|Radiation|radiotherapy|
16267007|NCT00887146|Drug|procarbazine|Days 8-21: 60 mg/m^2 orally
16267008|NCT00887146|Drug|adjuvant temozolomide (TMZ)|150 or 200 mg/m^2 orally
16267009|NCT00887146|Drug|CCNU|Day 1: 110 mg/m^2 orally
16267010|NCT00887146|Drug|vincristine|Days 8 and 29: 1.4 mg/m^2 IV
16267011|NCT00887120|Drug|Lopinavir/ritonavir standard dose According to WHO simplified dosing table|"BW 6-7.9 kg: 1.5 mL oral q 12 hr
~BW 8.0-16.9 kg: 2.0 ml oral q 12 hr
~BW 17.0-19.9 kg: 2.5 ml oral q 12 hr
~BW 20.0 - 24.9 kg: 3.0 ml oral q 12 hr
~BW 25.0 - 29.9 kg: 3.5 ml oral q 12 hr
~BW 30.0-34.9 kg: 4.0 ml oral q 12 hr
~BW > 35 kg: 5.0 ml oral q 12 hr
~Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)"
16267012|NCT00887120|Drug|Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)|"BW 6-7.9 kg: 1.0 mL oral q 12 hr
~BW 8.0-16.9 kg: 1.5 ml oral q 12 hr
~BW 17.0-19.9 kg: 1.8 ml oral q 12 hr
~BW 20.0 - 24.9 kg: 2.0 ml oral q 12 hr
~BW 25.0 - 29.9 kg: 2.5 ml oral q 12 hr
~BW 30.0-34.9 kg: 3.0 ml oral q 12 hr
~BW > 35 kg: 3.5 ml oral q 12 h
~Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)"
16267013|NCT00887107|Drug|Sorafenib (nexavar)|6 months therapy with Sorafenib 800 mg/day
16267014|NCT00887094|Behavioral|Acute aerobic exercise|Aerobic exercise (on a cycle ergometer, for 50 min)
16267015|NCT00887094|Behavioral|Acute aerobic-resistance exercise|Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)
16267016|NCT00887081|Drug|PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin|PEG-IFN alpha2a 180 mcg weekly or PEG-IFN alpha2b 1.5 mcg/kg of body weight weekly plus ribavirin 800-1200 mg daily according to body weight.
16267017|NCT00887068|Drug|Azacitidine|32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
16267018|NCT00887055|Device|CRT device|
16267019|NCT00887042|Drug|Fludarabine, Busulfan, Thymoglobulin|fludarabine (40 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4 & -3) busulfan (0.8 mg/kg every 6 hours i.v. on days -6, -5, -4, & -3) thymoglobulin (2.5 mg/kg once daily i.v. on days -8, -7, & -6)
16267020|NCT00887029|Drug|DuoTrav (travoprost-timolol ophthalmic drops)|topical ophthalmic drops instilled 1 drop daily
16267021|NCT00887029|Drug|Xalacom (latanoprost-timolol ophthalmic drops)|topical ophthalmic drops instilled 1 drop daily
16267022|NCT00887003|Drug|Bupivacaine|Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
16267023|NCT00887003|Drug|Bupivacaine|Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
16267024|NCT00887003|Drug|Bupivacaine|High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
16267025|NCT00887003|Drug|Bupivacaine|High Volume, High Dose (10cc, 10mg plain Bupivacaine)
16267026|NCT00887003|Drug|Depo-Medrol|80mg Depo-Medrol
16267027|NCT00886990|Drug|ritonavir-boosted PI-based second line treatments|single PI boosted by low dose ritonavir
16267028|NCT00886990|Drug|two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir|two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir
16267029|NCT00886977|Drug|YAM80|Oral administration, 2 to 6 mg, once a day.
16267030|NCT00886964|Biological|Intradermal HBV 1 course|"Dosage: 2 microgram (mcg), 0.1 ml per dose
~Location: left deltoid area x 1 injection
~Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months"
16267031|NCT00886964|Biological|Intramuscular HBV I course|"Dosage: 2 microgram (mcg), 0.1 ml per dose
~Location: left deltoid area x 1 injection
~Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months"
16267032|NCT00886951|Drug|I123MNI388/I123MNI390|Subjects will be dosed by intravenous injection up to 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) 123-I MNI-388 or 123-I MNI-390.
16267033|NCT00886938|Device|Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study|Repetitive transcranial magnetic stimulation, pilot study
16267034|NCT00886925|Drug|Albumin|Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
16267035|NCT00886925|Drug|Sodium chloride 0.9%|Day 0: 400-600 ml. Day 2: 200-400 ml.
16267036|NCT00886912|Other|hypoxia|training in simulated altitude in a hypoxic chamber (normobaric hypoxia)
16267037|NCT00886912|Other|normoxia|training under normoxic conditions
16267038|NCT00886899|Device|Recanalization of a coronary chronic total occlusion|Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
16267039|NCT00886886|Drug|MDMA|125 mg, single dose
16267040|NCT00886886|Drug|Reboxetine, 8 mg|two doses 12h and 2h before MDMA
16267041|NCT00886886|Drug|Placebo|capsules identical to MDMA or Reboxetine
16267042|NCT00886873|Drug|Mifepristone|
16267043|NCT00886860|Drug|misoprostol|misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
16267044|NCT00886860|Drug|misoprostol|misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
16267045|NCT00886847|Procedure|Lymph Node Needle Tissue Collections|Total of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC).
16267046|NCT00886834|Drug|Misoprostol|400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.
16267047|NCT00886834|Drug|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
16267048|NCT00886821|Biological|CVX-096|Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
16267049|NCT00886808|Drug|iCo-007 Intravitreal Injection|single dose iCo-007 Intravitreal Injection
16267050|NCT00886795|Drug|abatacept (Orencia ®)|4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.
16267051|NCT00886782|Drug|Cdc7-inhibitor|Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months
16267052|NCT00886769|Drug|Canakinumab|Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
16267053|NCT00886769|Drug|Placebo|Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.
16267054|NCT00886756|Drug|AZD8529|Oral
16267055|NCT00886756|Drug|Placebo|Oral
16267056|NCT00886743|Drug|oprelvekin|injection, 50 mg/kg, once daily
16267057|NCT00886730|Behavioral|Simple Card|"Participants will receive a simple 3x5 card with the name of the website and the following description. www.psychobabble.com (or new name). A website to help individuals with depression recover."
16267058|NCT00886730|Behavioral|Patient Centered Brochure|"Participants will receive an 8x11 handout that provides a more complete description of the depression website. The handout will be based on a patient perspective with samples of Internet postings from users. This card will emphasize peer-to-peer support and not mention health care organizations or health care provider endorsements. The information will address potential barriers to use: user will not be identified, posting will not take that much time, information from peers can be checked for accuracy with other peers and providers, and helping patient learn how to tell their usual health care providers about their activities on the Internet site. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. They will still be part of the study even if they will not provide their email."
16267059|NCT00886730|Behavioral|Physician's endorsement|Participants will include the same card in experimental group 2 with the addition of a personal endorsement by the patient's health care provider in the form of a standardized letter signed by the physician. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks.
16267060|NCT00886717|Drug|carboplatin|
16267061|NCT00886717|Drug|paclitaxel-loaded polymeric micelle|
16267062|NCT00886704|Dietary Supplement|500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA)|"Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized..
~Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug.
~Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil."
16267063|NCT00886704|Dietary Supplement|Control convenience drink|Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
16267064|NCT00886691|Biological|Bevacizumab|Given IV
16267065|NCT00886691|Drug|Everolimus|Given PO
16267066|NCT00886691|Other|Laboratory Biomarker Analysis|Correlative studies
16267067|NCT00886691|Other|Placebo|Given PO
16267068|NCT00886678|Drug|pemetrexed|500 mg/m2, IV, q 21 days x 2 cycles
16267069|NCT00886678|Drug|carboplatin|AUC=5,IV,q 21 days x 2 cycles
16267070|NCT00886678|Radiation|thoracic radiation|66 Gy over 33 fractions
16267071|NCT00886665|Drug|placebo|placebo, 4 g, powder, oral, 3 times a day
16267072|NCT00886665|Drug|JWHGWT|JWHGWT, 4 g, powder, oral, 3 times a day
16267073|NCT00886652|Other|Aerobic exercise program|Three weekly sessions, with an interval of one day between each, lasting 60 minutes each, and divided into three separate stages: - A 10-minute warm-up (stretching and low intensity aerobic exercises such as slow, gradual walking); - 40 minutes of aerobic exercise on an electric treadmill, with the work intensity maintained at a 60% to 80% of the maximum heart rate; - 10 minutes of winding down and relaxation (stretching exercises, low energy expenditure aerobics and relaxation techniques).
16267074|NCT00886639|Other|6MWT with oxygen|2 liter per minute as continuous-flow
16267075|NCT00886639|Other|6MWT with medical air|2 liters as continuous-flow
16267076|NCT00886626|Drug|Exenatide|Exenatide, subcutaneous injection, 10 mcg, twice per day
16267077|NCT00886613|Biological|V212|Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31
16267078|NCT00886613|Biological|Comparator: Zostavax™|Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31
16267186|NCT00885729|Other|Rehabilitation program|Strength exercises, neuromuscular exercises
16267079|NCT00886613|Biological|Comparator: Placebo|Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31
16267080|NCT00886613|Other|VZV Skin Test|Three intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination.
16267081|NCT00886613|Other|Saline|One intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms.
16267082|NCT00886600|Drug|losartan potassium|losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
16267083|NCT00886600|Drug|Comparator: placebo|placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
16267084|NCT00886600|Drug|hydrochlorothiazide (HCTZ)|open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
16267085|NCT00886587|Device|F# 11054-010|Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
16267086|NCT00886587|Device|F# 10495-053|Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
16267087|NCT00886574|Drug|Cilostazol|Cilostazol 200 mg (50 mg 2T twice per day)
16267088|NCT00886574|Drug|Aspirin|100 mg once a day
16267089|NCT00886561|Behavioral|HIV risk reduction intervention|Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia
16267090|NCT00886548|Procedure|Ultrasound performed|Nurse-driven ultrasound performed
16267091|NCT00886522|Procedure|Intrabone cord blood infusion|"Myeloablative conditioning regimen (MAC):
~i.v. Busulfan 12.8 mg/kg, Cyclophosphamide 120 mg/kg, ATG-Fresenius 30 mg/kg
~Reduced intensity conditioning regimen (RIC):
~Tiothepa 10 mg/kg, Fludarabine 100 mg/kg, Cyclophosphamide 100 mg/kg, ATG-Fresenius 30 mg/kg
~GVHD prophylaxis:
~Cyclosporine 1 mg/kg since day -7 to +120, Mycophenolate 15 mg kg x 2 since day +1 to +27"
16267092|NCT00886509|Biological|pegfilgrastim|s.c. administration of pegylated G-CSF over 6 months
16267093|NCT00886509|Other|Placebo|Placebo control Arm 1: Collateral promotion; PCI after 6 months
16267094|NCT00886496|Biological|recombinant human mannose-binding lectin|
16267095|NCT00886483|Device|Active Neurofeedback|A comparison of active neurofeedback to sham neurofeedback and of two treatment schedules: twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
16267096|NCT00886483|Device|Sham neurofeedback|Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
16267097|NCT00886470|Biological|ST266|ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
16267098|NCT00886457|Drug|Decitabine and Pegylated Interferon-Alfa 2B|Patients will receive decitabine 3.7 mg/m2/day i.v. over 1 hour daily in 10 doses over 2 weeks elapsed time (Monday-Friday) every 28 days plus fixed dose of PEG-Intron (0, 0.5, 1.5, 3 or 6 mcg/kg PEG-Intron) weekly by subcutaneous injection in 28-day cycles .
16267099|NCT00886444|Drug|Ferucarbotran (Resovist)|single time intravenous bolus injection of a contrast agent
16267100|NCT00886431|Other|embryo vitrification|Ultra rapid cooling of embryos by immersion in liquid nitrogen. The formation of potentially damaging ice crystals is prevented by briefly incubating the embryos in high concentrations of a mix of cryoprotectants.
16267101|NCT00886418|Drug|muscle relaxant|muscle relaxant administration throughout anesthesia
16267102|NCT00886418|Drug|normal saline|no muscle relaxant throughout anesthesia (normal saline infused as a placebo)
16267103|NCT00886405|Drug|Transdermal nitroglycerin|Transdermal nitroglycerin (25mg/day) during 5 days (2 days before and 3 days after chemotherapy) at the beginning of each chemotherapy cycle for a total of 4 cycles
16267104|NCT00886379|Dietary Supplement|Mongolian milk without vitamin D|710ml per day for 49 days
16267105|NCT00886379|Dietary Supplement|Mongolian milk with vitamin D|710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
16267106|NCT00886379|Dietary Supplement|UHT milk|710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
16267107|NCT00886379|Dietary Supplement|Milk Substitute|710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
16267108|NCT00886379|Dietary Supplement|Seasonal D supplement|Deliver dosage of 13,700 IU vitamin D over 7 days
16267109|NCT00886379|Dietary Supplement|Daily D supplement|Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
16267110|NCT00886366|Drug|AZD6714|Oral single doses a-h suspension
16267111|NCT00886366|Drug|Placebo|Oral single doses suspension
16267112|NCT00886366|Drug|AZD6714|Oral single doses a-d suspension
16267113|NCT00886366|Drug|AZD6714|Oral single doses d and g suspension
16267114|NCT00886353|Biological|APN01|APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.
16267115|NCT00886353|Other|Placebo|Physiological saline administrated i.v.
16267116|NCT00886340|Behavioral|Enhanced standard care|One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
16267117|NCT00886340|Behavioral|Lifestyle counseling|Enhanced standard care Six appointments with nurse practitioner (20 minutes)
16267118|NCT00886327|Procedure|Colonic capsule endoscopy|
16267119|NCT00886314|Drug|midazolam|Children in this group will be premedicated with oral midazolam syrup (0.3 mg.kg) at least 15 minutes before the surgical procedure and one of the parents will be present throughout the anesthesia induction process.
16267187|NCT00885716|Behavioral|patient training in shared decision making|
16267188|NCT00885716|Behavioral|cognitive training|
16267120|NCT00886314|Other|clown doctor|Children will interact with clowns before entering the operating room and will stay with them and one of the parents throughout the anesthesia induction process.
16267121|NCT00886301|Procedure|liver biopsy|liver biopsy
16267122|NCT00886275|Drug|Dexmedetomidine|The loading dose of dexmedetomidine is 0.5 mcg/kg over 10 minutes as needed. Then, continuous infusion of 0.2-0.7 mcg/kg/h dexmedetomidine is used to maintain RASS between 0 to -3.
16267123|NCT00886275|Drug|Midazolam|The loading dose of midazolam is 0.05 mg/kg over 10 minutes as needed. Then, continuous infusion of 20-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
16267124|NCT00886275|Drug|Dexmedetomidine, Midazolam|The loading doses are dexmedetomidine 0.25 mcg/kg and 0.025 mg/kg of midazolam over 10 minutes. Then, continuous infusion of 0.1-0.7 mcg/kg/h dexmedetomidine and 10-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
16267125|NCT00886262|Drug|Vasopressin|Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
16267126|NCT00886262|Drug|Normal saline placebo|Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
16267127|NCT00886249|Device|Acrysof IQ|Intraocular lens
16267128|NCT00886249|Device|Acrysof Natural IOL|Intraocular Lens
16267129|NCT00886236|Drug|Gabapentin|Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
16267130|NCT00886236|Drug|Placebo|Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
16267131|NCT00886236|Drug|Gabapentin|Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
16267132|NCT00886223|Procedure|laparoscopic robot-assisted sacropexy|Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
16267133|NCT00886210|Procedure|intra abdominal drain|Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) inserted at the end of operation.
16267134|NCT00886210|Procedure|LC without drain|Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group no drain at the end of operation.
16267135|NCT00886184|Procedure|Hypothermia.|Induction of pre hospital therapeutic hypothermia.
16267136|NCT00886184|Procedure|No early hypothermia|Induction of therapeutic hypothermia only once arrived at hospital.
16267137|NCT00886171|Behavioral|Social Skills Training|Social skills group will consist of one session (60 minutes) per week for 8 weeks
16267138|NCT00886171|Behavioral|Physical Activity Training|Physical activity groups consist of one session (60 minutes) per week for 8 weeks
16267139|NCT00886145|Device|Vibration: Right Leg and No Vibration: Left Leg.|"Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
~No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
16267140|NCT00886132|Drug|Sunitinib|37.5 mg taken orally, daily every 28-day cycles
16267141|NCT00886119|Device|Lotrafilcon B multifocal contact lens|Silicone hydrogel, soft, multifocal contact lens for daily wear use
16267142|NCT00886119|Device|Omafilcon A multifocal contact lens|Hydrogel, soft, multifocal contact lens for daily wear use
16267143|NCT00886106|Drug|Remifentanil|Remifentanil (Ultiva®; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to circa 0.7 µg kg-1 min-1
16267144|NCT00886106|Drug|Midazolam|Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied intravenously as active placebo at a dose of 15 µg kg-1 min-1 over 5 minutes to mimic typical central nervous side effects of remifentanil
16267145|NCT00886093|Drug|PF-04447943|35 mg tablet of PF-04447943 taken in the fed state in Period 1 followed a week later by administration of the same tablet and dose taken in the fasted state in Period 2
16267146|NCT00886093|Drug|PF-04447943|35 mg tablet of PF-04447943 taken in the fasted state in Period 1 followed a week later by administration of the same tablet and dose in the fed state in Period 2.
16267147|NCT00886080|Procedure|Pulmonary vein isolation using microwave energy|The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. The off-pump beating heart ablation procedure is performed according to a specific box lesion surrounding the pulmonary veins, using microwave energy. Afterwards cardiac surgery is performed as usual in both treatment arms.
16267148|NCT00886067|Drug|AZD1446|Solution, oral, single dose
16267149|NCT00886067|Radiation|2-[18F]-F-A85380|iv, single dose
16267150|NCT00886041|Procedure|laparoscopy|subjected to laparoscopy
16267151|NCT00886041|Other|ovarian stimulation|ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
16267224|NCT00885404|Drug|Lower chloride fluids (Hartmann's solution and Plasmalyte®)|Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.
16267152|NCT00886028|Drug|Liposomal doxorubicin|"Liposomal doxorubicin 60 mg/m2 every 4 weeks for 6 cycles.
~Thirty patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM from the Instituto Nacional de Cancerología and the Instituto Nacional de Enfermedades Respiratorias were included to receive LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles."
16267153|NCT00886028|Drug|Cisplatin|"Cisplatin 80 mg/m2 every 4 weeks for 6 cycles.
~Thirty patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM from the Instituto Nacional de Cancerología and the Instituto Nacional de Enfermedades Respiratorias were included to receive LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles."
16267154|NCT00886015|Device|TT Clamp|trichiasis surgery performed with TT clamp
16267155|NCT00886015|Procedure|Standard BLTR Technique|bilamellar tarsal rotation procedure in trichiasis surgery
16267156|NCT00886002|Drug|Fentanyl; Buprenorphine; Naloxone|
16267157|NCT00885989|Drug|SLV338|5 - 1000 mg IV
16267158|NCT00885989|Drug|Placebo|Placebo
16267159|NCT00885963|Drug|sapacitabine|twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
16267160|NCT00885937|Drug|Dexpanthenol (Sinecort, BAY81-2996)|1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
16267161|NCT00885937|Drug|Positive control, Na-laurylsulfat-solution|50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
16267162|NCT00885937|Device|Untreated skin under application chamber|Application of treatment chamber as in arm 1 and arm 2 on untreated skin
16267163|NCT00885924|Drug|Desmopressin|Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
16267164|NCT00885924|Drug|Placebo|NaCl 0.9%
16267165|NCT00885898|Procedure|Non-invasive-ventilation|increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
16267166|NCT00885898|Procedure|conventional treatment|oxygen, diuretics, bronchodilators, positive inotropic drugs
16267167|NCT00885885|Drug|Panitumumab+FOLFOX-4|"Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
~A cycle of panitumumab is defined as 14 days.
~FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle:
~Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle
~Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2
~A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2
~5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2"
16267168|NCT00885885|Drug|Panitumumab+FOLFIRI|"Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
~A cycle of panitumumab is defined as 14 days.
~FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle:
~Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle
~Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing
~A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1
~5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle."
16267169|NCT00885872|Drug|Rosuvastatin (Crestor)|at visit 2 each eligible subject will be allocated to rosuvastatin. study medication wil be taken orally with water once daily, as directed by the study physician. subjects who meet the criteria at visit 3, dosage of rosuvastatin will be titrated.
16267170|NCT00885859|Device|TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]|Patients are instructed how to use the TENS device during the two weeks at home.Self-adhesive reusable electrodes are used to deliver the electrical stimulation. The frequency is 100 Hz, pulse duration 250 μ sec. Stimulus intensity is strong but not unpleasant. The TENS electrodes are attached proximally and distally around the maximum pain point/area. Patients use TENS 4 times daily (30 minutes each time).
16267171|NCT00885846|Other|Qigong therapy|For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
16267172|NCT00885846|Other|Progressive resistance training|For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
16267173|NCT00885833|Drug|Fludarabine, Busulfan, Thymoglobulin|fludarabine (40 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4 & -3) busulfan (0.8 mg/kg every 6 hours i.v. on days -6, -5, -4, & -3) thymoglobulin (2.5 mg/kg once daily i.v. on days -8, -7, -6 for cord blood and on days -4, -3, -2 for bone marrow or mobilized peripheral blood)
16267174|NCT00885820|Drug|Tacrolimus|Oral
16267175|NCT00885820|Drug|MMF|Oral
16267176|NCT00885820|Drug|Corticosteroids (Prednisone)|Oral
16267177|NCT00885794|Drug|Ranibizumab|3 intravitreal injection every 5 weeks
16267178|NCT00885781|Drug|lipid emulsion for TPN|1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
16267179|NCT00885768|Procedure|angiography|all patients undergoing coronary angiography with VISIPAQUE and if they had coronary stenosis then renal artery angiography will be done. the dose of contrast will be chosen according to renal function and clinical conditions which will be varied from 75 to 300 ml.
16267180|NCT00885755|Drug|Standard taxane therapy|As prescribed
16267181|NCT00885755|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)
16267182|NCT00885755|Drug|trastuzumab [Herceptin]|8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle
16267183|NCT00885742|Biological|FXIII Concentrate (Human)|"Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.
~Subjects enrolled in this study who did not complete the pharmacokinetic study (Factor XIII Study BI71023_2002 [NCT00883090]) will initially receive FXIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion."
16267184|NCT00885729|Procedure|stem cells|Stem cells or chondrocytes under a commercial available membrane
16267185|NCT00885729|Procedure|Chondrocytes|Implantation of chondrocytes
16267189|NCT00885703|Drug|Fluconazole|"Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
16267190|NCT00885703|Drug|Amphotericin B|Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
16267191|NCT00885690|Drug|Sertindole|Sertindole 16-24 mg once daily
16267192|NCT00885690|Drug|Olanzapine|Olanzapine 10-20 mg
16267193|NCT00885677|Device|Medtronic CareLink® Network|"Continuous monitoring via a disease remote management system.
~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
16267194|NCT00885664|Drug|Truvada (tenofovir/emitricitabine)|Tenofovir/emitricitabine fixed dose combination once daily
16267195|NCT00885664|Drug|Kaletra (lopinavir/ritonavir)|Lopinavir/ritonavir 400/100 mg twice daily
16267196|NCT00885651|Drug|Metoprolole (Selo-Zok ®)|Tablets, 200 mg, once a day, 10 days
16267197|NCT00885651|Drug|Placebo|
16267198|NCT00885638|Drug|Sitagliptin|100 mg sitagliptin before ingestion of macronutrient
16267199|NCT00885638|Drug|placebo|A placebo tablet is given before ingestion of macronutrients
16267200|NCT00885625|Biological|7-valent pneumococcal conjugated vaccine|7-valent pneumococcal conjugated vaccine is given twice with 4 weeks apart
16267201|NCT00885599|Drug|Herbal API|mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
16267202|NCT00885599|Drug|Cepacol|mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
16267203|NCT00885599|Drug|Listerine Antiseptic Mouth Rinse|mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
16267204|NCT00885599|Drug|placebo mouthwash|colored water mouthwash;rinse full strength for 30 seconds with 20 ml (2/3 fl. Ounce or 4 teaspoonfuls) morning and night.
16267205|NCT00885586|Device|Sham-laser acupuncture|Laser irradiation is faked, approaching a non-functioning laser pen.
16267206|NCT00885586|Drug|gabapentine|Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer
16267207|NCT00885586|Procedure|Acupuncture|The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
16267208|NCT00885573|Device|Measurement of pharyngeal sensitivity (SENSITEST)|Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
16267209|NCT00885547|Drug|tripterygium wilfordii (TW)|90 mg/d for 6 months
16267210|NCT00885534|Drug|Cisplatin, Vinblastine, Temozolomide|"Patients will receive CVT chemotherapy which consists of the following:
~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
16267211|NCT00885521|Other|Exercise|8 week, twice weekly exercise program with endurance and upper and lower limb strength training
16267212|NCT00885508|Drug|Lenalidomide|"Induction treatment Lenalidomide 10 mg once daily PO during 3 weeks . in combination with classical 7+3 chemotherapy.
~Consolidation treatment 6 monthly courses of : Lenalidomide 10 mg/ d during the first 2 weeks in combination with classical 5+1 consolidation chemotherapy
~Maintenance treatment Lenalidomide 10 mg/d 2 weeks every month until relapse
~In absence of toxicity, 20 additionnal patients will be included with lenalidomide dose of 25mg/J, then 20 other additionnals patients with Lenalidomide 50mg/J"
16267213|NCT00885495|Drug|darunavir, ritonavir, rosuvastatin|darunavir 600 mg twice daily for 7 days ritonavir 100 mg twice daily for 7 days rosuvastatin 10 mg once daily for 7 days Combination of all three drugs for 7 days
16267214|NCT00885495|Drug|rosuvastatin, darunavir, ritonavir|rosuvastatin 10 mg daily for 7 days; darunavir 600 mg twice daily for 7 days with ritonavir 100 mg twice daily for 7 days; Combination of all three for 7 days
16267215|NCT00885482|Drug|Lamiduvine (Epivir)|Epivir 300 mg
16267216|NCT00885482|Drug|Atazanavir (Reyataz)|Reyataz 300 mg
16267217|NCT00885482|Drug|Ritonavir (Norvir)|Norvir 100 mg
16267218|NCT00885456|Behavioral|PREVENT program|12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
16267219|NCT00885456|Behavioral|Usual Care|Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
16267220|NCT00885443|Drug|Propofol|Patients will be anesthetised according to standard induction protocols with propofol/remifentanil intravenously. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.
16267221|NCT00885443|Drug|sevoflurane|Patients will be anesthetised according to standard induction protocols with sevoflurane by inhalation. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.
16267222|NCT00885430|Drug|Pico-Salax|Two sachets of Pico-Salax given 5 hours apart
16267223|NCT00885417|Drug|Cravit-based sequential therapy|Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
16267225|NCT00885378|Drug|Saxagliptin plus metformin IR|Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
16267226|NCT00885378|Drug|Placebo plus metformin IR|Tablets, Oral, Placebo, Twice daily, 12 weeks
16267227|NCT00885365|Drug|tobramycin / Bramitob|300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
16267228|NCT00885365|Drug|tobramycin / TOBI|300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen
16267229|NCT00885352|Drug|Sitagliptin|Sitagliptin 100 mg tablet orally once daily for 26 weeks.
16267230|NCT00885352|Drug|Comparator: Placebo|Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks.
16267231|NCT00885352|Drug|Pioglitazone|Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks.
16267232|NCT00885352|Drug|Metformin|Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks.
16267233|NCT00885352|Drug|Glipizide|Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.
16267234|NCT00885326|Drug|Bevacizumab|Every course will be 28 days. Bevacizumab 10 mg/kg/dose , will be administered intravenously every 14 days beginning on day 0 of the second course.
16267235|NCT00885326|Drug|cyclophosphamide|Cyclophosphamide will be administered as an intravenous (IV) bolus according to the protocol assigned dose level followed by daily oral dosing (25mg/m2/day) without interruption (unless toxicity supervenes).
16267236|NCT00885326|Drug|zoledronic acid|Administered on day 0 of course 1 and day 1 of course 2 and all subsequent courses in a dose of 4mg/m2 (max 4 mg per dose). On days when zoledronic acid (ZA) and cyclophosphamide (CTX) are given together, CTX should be given first.
16267237|NCT00885313|Drug|DHA250|DHA 250 mg/kg/d
16267238|NCT00885313|Drug|DHA500|DHA 500 mg/kg/d
16267239|NCT00885313|Drug|PLACEBO|placebo
16267240|NCT00885313|Behavioral|Lifestyle intervention|lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
16267241|NCT00885300|Drug|cloxacillin|cloxacillin 100mg/ml as catheter lock at the end of hemodialysis
16267242|NCT00885300|Drug|heparin|heparin 1000iu/ml as catheter lock at the end of hemodialysis
16267243|NCT00885287|Drug|Artemether-lumefantrine (AL)|Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines
16267244|NCT00885274|Drug|Pico-Salax|Both doses of Pico-Salax taken the evening prior to colonoscopy
16267245|NCT00885274|Drug|Split Dose Pico-Salax|One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.
16267246|NCT00885222|Device|DBS parameters setting|DBS parameters will be set to increase the DBS affected volume to include both the cognitive and limbic territories in addition to the dorso-lateral motor territories of the STN. This novel approach to parameter selection is directed to achieve improvement in cognitive and limbic as well as motor domains of PD. The patients will therefore be assessed for cognitive, limbic and motor state at multiple time points; there will be a baseline assessment prior to starting treatment (prior to DBS surgery and/or prior to parameters changes); thereafter assessments will follow the stimulation parameter changes; thereafter follow-up assessments at 6 - 12 months. Stimulation parameters will be changed every 2 weeks or earlier if an urgent clinical state emerges. Patients with depression will be monitored for antidepressant effects of stimulation changes. Patients without depression will be monitored for evidence of treatment emergent depression.
16267247|NCT00885196|Drug|Placebo|
16267248|NCT00885196|Drug|AEB071|
16267249|NCT00885183|Procedure|Acupuncture therapy|12 acupuncture treatment sessions for a period of 16 weeks
16267250|NCT00885170|Drug|Odanacatib|Odanacatib 50 mg tablets once weekly for 24 months
16267251|NCT00885170|Drug|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months
16267252|NCT00885170|Dietary Supplement|Vitamin D3|Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
16267253|NCT00885170|Dietary Supplement|Calcium|Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
16267254|NCT00885157|Biological|Inactivated types 1, 2, and 3 poliovirus, D antigens|0.1 mL, intradermal
16267255|NCT00885157|Biological|Inactivated types 1, 2, and 3 poliovirus, D antigens|0.5 mL, Intramuscular
16267256|NCT00885144|Dietary Supplement|Nutributter|"Test dose of standard supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation."
16267257|NCT00885144|Dietary Supplement|LNS-20gM|Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
16267258|NCT00885144|Dietary Supplement|LNS-20gNoM|Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
16267259|NCT00885144|Dietary Supplement|LNS-10gM|Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
16267260|NCT00885118|Drug|Placebo (middle dose)|Placebo tablets once a day
16267261|NCT00885118|Drug|Placebo|Placebo tablets once a day
16267262|NCT00885118|Drug|BI 10773|BI 10773 middle dose tablets once a day
16267263|NCT00885118|Drug|BI 10773|BI 10773 high dose tablets once a day
16267264|NCT00885118|Drug|BI 10773|BI 10773 middle dose tablets once a day
16267265|NCT00885118|Drug|Placebo (high dose)|Placebo tablets once a day
16267266|NCT00885118|Drug|BI 10773|BI 10773 low dose tablets once a day
16267267|NCT00885118|Drug|Placebo (low dose)|Placebo tablets once a day
16267268|NCT00885105|Biological|Influenza Virus Vaccine|0.25 mL, Intramuscular
16267269|NCT00885105|Biological|Influenza Virus Vaccine|0.25 mL, Intramuscular
16267270|NCT00885092|Device|FID 114675A Multi-Purpose Disinfecting Solution (MPDS)|Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.
16267271|NCT00885092|Device|RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)|Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
16267272|NCT00885092|Device|Senofilcon A contact lens (ACUVUE® Oasys™)|Commercially marketed silicone hydrogel contact lens for daily wear use
16267273|NCT00885092|Device|Balafilcon A contact lens (PureVision®)|Commercially marketed silicone hydrogel contact lens for daily wear use
16267274|NCT00885079|Drug|OPC-12759 Ophthalmic suspension|OPC-12759 Ophthalmic suspension 2%
16267275|NCT00885079|Drug|Hyalein Mini Ophthalmic solution|Hyalein Mini Ophthalmic solution 0.1%
16267276|NCT00885066|Drug|capecitabine|
16267277|NCT00885066|Drug|erlotinib hydrochloride|
16267278|NCT00885066|Drug|gemcitabine hydrochloride|
16267279|NCT00885053|Dietary Supplement|fish oil|Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks
16267280|NCT00885053|Dietary Supplement|olive oil|Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
16267281|NCT00885014|Behavioral|CBT|Telephone cognitive-behavioral therapy
16267282|NCT00885014|Behavioral|EAP|Employees Assistance Program
16267283|NCT00885001|Procedure|Short Arc Banding|Lumbar extension on the ATM II from back project. Rehabilitation exercise intervention.
16267284|NCT00884988|Drug|Lymphomyosot|20 drops X3/day, until discharge
16267285|NCT00884988|Drug|Placebo remedy|20 drops X3/day, until discharge
16267286|NCT00884962|Device|Polymeric Lung Volume Reduction System (PLVR)|20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.
16267287|NCT00884949|Drug|BMN 110|"Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
~Weeks 1-12: 0.1 mg/kg/week
~Weeks 13-24: 1.0 mg/kg/week
~Weeks 25-36: 2.0 mg/kg/week
~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
16267288|NCT00884910|Device|Provox Vega voice prosthesis 22.5 Fr|The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
16267289|NCT00884897|Drug|Oxytocin|Oxytocin given as 20 IU BID
16267290|NCT00884897|Drug|Placebo|Placebo given as 20 IU BID
16267291|NCT00884884|Drug|Double Placebo|1 capsule daily
16267292|NCT00884884|Drug|Aripiprazole 15, placebo|15 mg Aripiprazole daily plus placebo daily
16267293|NCT00884884|Drug|Aripiprazole 7.5, Placebo|Aripiprazole 7.5 mg daily plus Placebo daily
16267294|NCT00884884|Drug|Topiramate 100, Placebo|Topiramate 100 mg daily plus Placebo daily
16267295|NCT00884884|Drug|Topiramate 200, Placebo|Topiramate 200 mg daily plus Placebo daily
16267296|NCT00884884|Drug|Topiramate 100, Aripiprazole 15|Topiramate 100 mg daily plus Aripiprazole 15mg daily
16267297|NCT00884884|Drug|Topiramate 100, Aripiprazole 7.5|Topiramate 100 mg daily plus Aripiprazole 7.5mg daily
16267298|NCT00884884|Drug|Topiramate 100, Aripiprazole 15mg|Topiramate 100 mg daily plus Aripiprazole 15mg daily
16267299|NCT00884884|Drug|Topiramate 200, Aripiprazole 7.5mg|Topiramate 200 mg daily plus Aripiprazole 7.5mg daily
16267300|NCT00884884|Drug|Topiramate 200, Aripiprazole 15|Topiramate 200mg daily plus Aripiprazole 15mg daily
16267301|NCT00884871|Procedure|LapBand|Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders
16267302|NCT00884858|Drug|Maraviroc|Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.
16267303|NCT00884845|Drug|PM02734 and erlotinib|PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
16267304|NCT00884845|Drug|Erlotinib|Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets
16267305|NCT00884832|Drug|Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
16267306|NCT00884832|Drug|Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
16267307|NCT00884819|Drug|Fenofibrate|fenofibrate 200 mg daily for 6-months
16267308|NCT00884819|Other|Placebo|Placebo match for 6 months
16267309|NCT00884806|Device|FID 114675A Multi-Purpose Disinfecting Solution (MPDS)|Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses
16267310|NCT00884806|Device|Etafilcon A contact lens (ACUVUE® 2™)|Commercially marketed hydrogel contact lens for daily wear use
16267311|NCT00884806|Device|Senofilcon A contact lens (ACUVUE® OASYS™)|Commercially marketed silicone hydrogel contact lens for daily wear use
16267312|NCT00884806|Device|Lotrafilcon B contact lens (O2 OPTIX®)|Commercially marketed silicone hydrogel contact lens for daily wear use
16267313|NCT00884806|Device|Balafilcon A contact lens (PureVision®)|Commercially marketed silicone hydrogel contact lens for daily wear use
16267405|NCT00884039|Drug|anecortave acetate|anterior juxtascleral depot of 15 mg anecortave acetate
16267406|NCT00884039|Drug|30 mg anecortave acetate|anterior juxtascleral depot of 30mg anecortave acetate
16267314|NCT00884793|Drug|raltegravir|The baseline ART regimen will be intensified with raltegravir 400mg orally (PO) twice daily (BID) (all participants) +/- a study NNRTI or protease inhibitor (PI) (at the option of the participant and the study clinical team).
16267315|NCT00884793|Drug|Study NNRTI|Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine).
16267316|NCT00884793|Drug|Study PI|Subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
16267317|NCT00884767|Drug|FOLFOX regimen|
16267318|NCT00884767|Drug|fluorouracil|
16267319|NCT00884767|Drug|leucovorin calcium|
16267320|NCT00884767|Drug|oxaliplatin|
16267321|NCT00884767|Genetic|gene expression analysis|
16267322|NCT00884767|Genetic|protein expression analysis|
16267323|NCT00884767|Genetic|proteomic profiling|
16267324|NCT00884767|Other|laboratory biomarker analysis|
16267325|NCT00884767|Other|pharmacogenomic studies|
16267326|NCT00884754|Device|GlideScope rigid stylet|Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.
16267327|NCT00884741|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-dimentional conformal radiation therapy
16267328|NCT00884741|Biological|Bevacizumab|Given IV
16267329|NCT00884741|Radiation|Intensity-Modulated Radiation Therapy|Undergo intensity-modulated radiation therapy
16267330|NCT00884741|Other|Laboratory Biomarker Analysis|Correlative studies
16267331|NCT00884741|Other|Placebo|Given IV
16267332|NCT00884741|Other|Quality-of-Life Assessment|Ancillary studies
16267333|NCT00884741|Drug|Temozolomide|Given orally
16267334|NCT00884715|Drug|Octreotide|short acting octreotide
16267335|NCT00884676|Drug|Ixabepilone|"Administered intravenously. Dosage assigned by Phase I center as determined by dose-escalation schedule:
~Schedule A: Weekly for 3 weeks each cycle (Days 1, 8 and 15)
~Schedule B: Day 1 of each 3-week cycle."
16267336|NCT00884676|Drug|Sunitinib|For both Schedules A and B, daily, orally, starting on Day 8 of Cycle 1
16267337|NCT00884663|Drug|Candesartan|Candesartan cilexitil tablets, 16 mg once daily
16267338|NCT00884663|Drug|propranolol|Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
16267339|NCT00884663|Drug|placebo|placebo tablets and capsules
16267340|NCT00884650|Drug|oral analgesic|per clinical standard of care
16267341|NCT00884650|Drug|intravenous analgesic per pump|per clinical standard of care
16267342|NCT00884611|Device|Predictive Low Glucose Suspend Algorithm ON|The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.
16267343|NCT00884611|Device|Predictive Low Glucose Suspend Algorithm OFF|
16267344|NCT00884598|Drug|cilengitide|
16267345|NCT00884598|Other|pharmacological study|
16267346|NCT00884598|Radiation|radiation therapy|
16267347|NCT00884585|Drug|Cyclosporine Vehicle|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
16267348|NCT00884585|Drug|Cyclosporine 0.010%|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
16267349|NCT00884559|Other|instruction|Debriefing
16267350|NCT00884546|Drug|BMS-833923|Capsule, Oral, Once daily, 6 months
16267351|NCT00884546|Drug|Lenalidomide|Capsule, Oral, Once daily, 6 months
16267352|NCT00884546|Drug|Dexamethasone|Capsule, Oral, Once a week, 6 months
16267353|NCT00884546|Drug|Bortezomib|Powder, IV, On days 1, 4, 8, 11, 6 months
16267354|NCT00884533|Drug|Rosi XR|Rosi XR
16267355|NCT00884533|Other|Placebo|Placebo
16267356|NCT00884533|Drug|Moxifloxacin|400mg single dose
16267357|NCT00884520|Drug|[F-18] VM4-037|"The individual doses of [F-18]VM4-037 contain a maximum of 20 mCi for normal volunteers and 10 mCi for cancer subjects.
~The single IP dose is administered to the study subject immediately prior to the start of PET imaging."
16267358|NCT00884507|Drug|Placebo|po daily for 24 weeks
16267359|NCT00884507|Drug|RO5313534|1mg po daily for 24 weeks
16267360|NCT00884507|Drug|RO5313534|5mg po daily for 24 weeks
16267361|NCT00884507|Drug|RO5313534|15mg po daily for 24 weeks
16267362|NCT00884494|Drug|Ghrelin infusion to assess effects on insulin sensitivity|
16267363|NCT00884481|Other|Natalizumab|Participants treated with Tysabri
16267364|NCT00884442|Drug|Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)|60 mg nifedipine
16267365|NCT00884442|Drug|Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)|60 mg nifedipine
16267366|NCT00884429|Procedure|Chest physiotherapy - Conventional|Percussion Postural Drainage and thorax compression
16267367|NCT00884429|Procedure|Chest physiotherapy - actual techniques|Slow prolonged expiration and clearance rhinopharynx retrograde
16267368|NCT00884429|Procedure|3-Airway suction|Airway suction
16267369|NCT00884416|Drug|Sorafenib dose escalation|Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid
16267370|NCT00884390|Drug|moroctocog alfa (AF-CC) (ReFacto AF)|Providing moroctocog alfa (AF-CC) as test article for use during this study.
16267371|NCT00884390|Procedure|Laboratory tests|Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.
16267372|NCT00884377|Drug|Sodium stibogluconate (Pentostam)|intravenous 20 mg/kg/day for 10 days
16267373|NCT00884377|Device|ThermoMed|ThermoMed heat treatment device, one treatment
16267374|NCT00884364|Other|Aerobic exercise|The patients will carry out an aerobic exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The training will be carried out three times a week.
16267480|NCT00883480|Drug|Docetaxel-Cisplatin|Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
16267375|NCT00884364|Behavioral|Fatigue counseling|The patients will receive a counseling regarding the causes of fatigue, how to cope with this symptom, and general recommendations about exercise. However, they will not participate at a structured exercise program.
16267376|NCT00884338|Other|Endurance exercise|The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate
16267377|NCT00884338|Other|Counseling|Counseling about exercise and behavioural techniques to reduce fatigue
16267378|NCT00884325|Drug|Levocetirizine dihydrochloride (Xyzal)|One tablet 5 mg taken orally at night for 28 days
16267379|NCT00884325|Drug|placebo|One tablet taken orally at night for 28 days
16267380|NCT00884312|Drug|Carfilzomib|Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
16267381|NCT00884299|Dietary Supplement|Diet rich in antioxidants|Dietary intervention based on diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients are advised by a physician and a specialist nurse during regular scheduled outpatient clinic visits to increase fresh fruit /fruit juices/vegetable consumption of at least one portion per day compared to baseline and to maintain this regime throughout the study period.
16267382|NCT00884286|Drug|Aplidin®|Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.
16267383|NCT00884273|Drug|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
16267384|NCT00884273|Drug|Goserelin|Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
16267385|NCT00884273|Drug|Bicalutamide|On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
16267386|NCT00884260|Drug|Levonorgestrel IUS (LCS, BAY86-5028)|In Vitro release rate: 12µg LNG/24h
16267387|NCT00884234|Other|Vehicle Control|Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
16267388|NCT00884234|Drug|RT001 (Botulinum Toxin Type A Topical Gel)|Two sequential doses of RT001 at Baseline (Day 0) and Week 2
16267389|NCT00884221|Drug|Highly purified menotrophin|"The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
~NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion."
16267390|NCT00884221|Drug|Recombinant FSH|"The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
~NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion."
16267391|NCT00884195|Behavioral|Gratitude Journaling|Participants will be asked to write down 5 things every day for which they are grateful.
16267392|NCT00884195|Behavioral|Neutral Journaling|Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.
16267393|NCT00884182|Biological|A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine|0.5 mL, Intramuscular
16267394|NCT00884169|Drug|M518101|Proper quantity twice a day
16267395|NCT00884169|Drug|placebo|Proper quantity twice a day
16267396|NCT00884130|Procedure|laparoscopic colorectal resection|
16267397|NCT00884130|Procedure|open colorectal resection|
16267398|NCT00884117|Drug|Oseltamivir|Participants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study.
16267399|NCT00884104|Drug|Solifenacin|Oral
16267400|NCT00884078|Other|Culturally adapted manualized problem solving training|The areas covered by the manual include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient. We will be able to linguistically match the therapist and the participant in three most common languages spoken and understood in South Asian population i.e. Urdu, Hindi and Punjabi.
16267401|NCT00884065|Other|Diacutaneous Fibrolysis|The implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook.
16267402|NCT00884065|Other|Diacutaneous Fibrolysis (placebo)|The placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes.
16267403|NCT00884052|Drug|Low dose levetiracetam|20 mg/kg loading dose; 5 mg/kg daily for 7 days.
16267404|NCT00884052|Drug|High dose levetiracetam|40 mg/kg IV load; 10 mg/kg/day maintenance
16267407|NCT00884026|Device|AIx measurement with a Sphygmacor TM|All subjects will have their AIx measured prior to surgery. After 30 subjects are recruited, they will be split into 2 groups. Group 1 will be those subjects who developed hypotension, and Group 2 will be those subjects who did not develop hypotension. We will then look at the preoperative measured AIx to determine whether there is a baseline difference between the two groups. A threshold value of the AIx with the best sensitivity and specificity for prediction of hypotension will then be determined.
16267408|NCT00884026|Device|AIx measurement with a Sphygmacor TM|The second part of the study will then use the threshold AIx value found from the subjects who developed hypotension from the first 30 subjects to prospectively predict hypotension after spinal anesthesia in another 60 subjects
16267409|NCT00884000|Drug|Genotropin|
16267410|NCT00884000|Drug|Zomacton|
16267411|NCT00883974|Behavioral|Sensitivity Training|"The parent sensitivity training program was delivered in NICU (9 sessions) with a home-booster session. Therapists worked with parents following a manualized protocol. Targets of intervention included: recognizing signs of infant stress, shut-down mechanisms, alert-available behavior, motor behaviors, facial expressions,posture/muscle tone; graded stimulation; how to optimize interactions; touch, movement and massage; kangaroo care (nesting infants skin-to-skin against their mother); vocal, visual and multi-sensory stimulation; normalizing parental feelings; challenging dysfunctional thinking, and diary keeping."
16267412|NCT00883961|Other|Supervised exercise|The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.
16267413|NCT00883948|Behavioral|Minimal (Trophic) Feeding|Upon admission to the ICU, enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.
16267414|NCT00883948|Behavioral|Full Feeding|Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.
16267415|NCT00883935|Drug|GSK1349572|GSK1349572 30 mg once a day for 5 days in Period 1 and 14 days in Period 2
16267416|NCT00883935|Drug|Atazanavir 300 mg|Atazanavir 300 mg once per day for 14 days in Period 2
16267417|NCT00883935|Drug|Atazanavir 400 mg|Atazanavir 400 mg once a day for 14 days in Period 2
16267418|NCT00883935|Drug|Ritonavir|Ritonavir 100 mg once a day for 14 days in Period 2
16267419|NCT00883909|Drug|dutasteride|A follow-up study in adult male subjects who have received investigational product
16267420|NCT00883896|Other|Placebo|Part 1: Placebo SC administration every 2 weeks X 10 weeks.
16267421|NCT00883896|Drug|ILV-094|Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
16267422|NCT00883896|Drug|ILV-094|Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.
16267423|NCT00883896|Other|Placebo|Part 2: Placebo SC administration every 2 weeks X 10 weeks
16267424|NCT00883896|Drug|ILV-094|Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks
16267425|NCT00883883|Drug|Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)|
16267426|NCT00883883|Drug|Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)|
16267427|NCT00883870|Drug|mesenchymal stem cells|Intramuscular injection
16267428|NCT00883870|Drug|Plasmalyte A|Intramuscular injection
16267429|NCT00883844|Drug|Nucleos(t)ide analogue treatment with a peginterferon add-on strategy|peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
16267430|NCT00883844|Drug|Nucleos(t)ide analogue treatment|Treatment with one of the approved nucleos(t)ide analogues
16267431|NCT00883831|Procedure|Individualized manual acupuncture|Acupuncture treatment will be provided according to traditional korean medicine (TKM) theory which focuses on patient's individual symptoms and conditions. 10-12 needles will be inserted into acupuncture point on the body except one arm where arteriovenous fistula is located for hemodialysis access. Needle retention time will be 30 minutes with intermittent manual stimulation to elicit de-qi sensation. Biweekly treatment will be conducted at non-dialysis access day or before hemodialysis at dialysis-access day for 6 weeks.
16267432|NCT00883818|Drug|azithromycin, doxycycline|"azithromycin 1g once for women with positive cultures at baseline
~doxycycline 100 mg twice daily for 7 days for women with persistent infection after treatment of azithromycin 1g"
16267433|NCT00883805|Biological|Blood draw|Subjects will give blood for analysis of metal ion concentrations
16267434|NCT00883805|Radiation|X-Ray of Hip|Subject will have x-ray of hip to assessment of osteolysis
16267435|NCT00883792|Procedure|Colonoscopy|Once-only colonoscopy screening
16267436|NCT00883779|Drug|Placebo|po on days 15-28 of each 4 week cycle until disease progression
16267437|NCT00883779|Drug|Platinum chemotherapy (cisplatin or carboplatin)|cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles
16267438|NCT00883779|Drug|erlotinib [Tarceva]|150mg po on days 15-28 of each 4 week cycle until disease progression
16267439|NCT00883779|Drug|gemcitabine|1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles
16267440|NCT00883766|Other|Controlled ovarian hyperstimulation for IVF with a long agonist protocol|"Day 1 of 1st menstruation: OC for 18-21 days (Microdiol ®) + Metformin (Dianben ®) 850 x 2/day if: BMI>30, HOMA >3.8, G/I ratio <4.5
~Day 18-24 of cycle: Leuprorelin (Procrin ®) 0.1 s.c. for 14-21 days
~Day 1 of 2nd menstruation (=Day 1 COH cycle): Hormonal profile (FSH, LH, E2, Pg, T, SHBG), Ultrasonography to exclude cyst >10 mm
~Day 2of COH cycle: rFSH (Gonal F ®) 150 IU/day for 4 days; Leuprorelin (Procrin ®) 0.1 s.c. (and following days)
~Day 7 of COH (and following): Measure FSH, LH, E2, Pg + Ultrasound
~Day before HCG: stop rFSH
~Day HCG: measure FSH, LH, E2, Pg, administer 250 mcg Choriogonadotropin-alfa ( Ovitrelle®)
~Day of pick-up: Follicular fluid from 1st follicle to be centrifuged and stored at -20°C
~Day 7 after pick-up: ultrasound, patient evaluation.
~Day 14 after pick-up: HCG in blood
~Day 28 after pick-up: Ultrasound to visualize heart beat if pregnancy test positive
~(OC= oral contraceptive; COH= Controlled Ovarian Hyperstimulation)"
16267481|NCT00883480|Drug|Gemcitabine-Cisplatin|"Cisplatin 75 mg/ day 1 x 4 cycles
~Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles"
16267441|NCT00883766|Other|Controlled ovarian hyperstimulation for IVF with an antagonist protocol|"Day 1 of pre COH-cycle: OC for 18-21 days (Microdiol ®) + Metformin (Dianben ®) 850 x 2/day if: BMI>30, HOMA >3.8, G/I ratio <4.5
~Day 3 of free-pill interval: Hormonal profile (FSH, LH, E2, Pg, T, SHBG), Ultrasonography to exclude cyst >10 mm
~Day 5 of free-pill interval (=Day 1 COH cycle): Cetrorelix acetate (Cetrotide®) 0.25 mg s.c. + rFSH (Gonal F ®) 150 IU/day (and following days)
~Day 3-4-10 of COH cycle: measure FSH, LH, E2, Pg + ECO
~Day before HCG: stop rFSH + cetrorelix
~Day HCG: measure FSH, LH, E2, Pg, administer 250 mcg Choriogonadotropin-alfa ( Ovitrelle®)
~Day of pick-up: Follicular fluid from 1st follicle to be centrifuged and stored at -20°C
~Day 7 after pick-up: ultrasound, patient evaluation.
~Day 14 after pick-up: HCG in blood
~Day 28 after pick-up: Ultrasound to visualize heart beat if pregnancy test positive (OC= oral contraceptive; COH= Controlled Ovarian Hyperstimulation)"
16267442|NCT00883753|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
16267443|NCT00883740|Drug|Pregabalin|Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
16267444|NCT00883740|Drug|Placebo|Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks
16267445|NCT00883727|Drug|Stem cell|IV infusion of stem cells
16267446|NCT00883727|Drug|Plasmalyte A|IV infusion
16267447|NCT00883714|Other|Supervised exercise|The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.
16267448|NCT00883714|Other|Exercise Instruction|The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.
16267449|NCT00883688|Drug|Bevacizumab|"10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week study cycle)."
16267450|NCT00883688|Drug|Lapatinib|Pills of 700 mg/m^2/dose given orally 2 times each day.
16267451|NCT00883675|Drug|Docetaxel-Carboplatin|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
16267452|NCT00883662|Drug|Levonorgestrel (Mirena, BAY86-5028)|Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
16267453|NCT00883649|Dietary Supplement|Hydroeye|2 Capsules BID
16267454|NCT00883649|Other|Inactive Capsule|2 Capsules BID
16267455|NCT00883636|Other|Cardiovascular Assessment|Measure of BNP, and Pro-BNP Complete 2 Dimensional Echocardiogram with Doppler evaluation including determination of, Left Ventricular mass, Ejection fraction, Midwall fractional shortening, velocity of early and late diastolic transmitral flow, and measurement of E/A ratio, Ratio of end-systolic wall stress to rate corrected velocity of circumferential fiber shortening.
16267456|NCT00883636|Other|Renal Assessment|Complete a metabolic panel, CMP. Calculation of glomerular filtration rate, GFR, measure of urinary total protein, albumin and creatinine excretion in a first morning urine sample, 24 hour blood pressure monitoring,
16267457|NCT00883636|Other|Genetic Evaluation|All patients will undergo genetic screening for all known podocyte gene mutations.
16267458|NCT00883623|Drug|Lenalidomide|Up to 6 cycles of oral L-Mel-Dex, every 28 days Revlimid® 10 mg daily for 21 days, (add on therapy), Melphalan 0.15 mg/kg/day day 1-4, Dexamethasone 20 mg day 1-4
16267459|NCT00883584|Drug|IMD-1041|Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
16267460|NCT00883584|Drug|Placebo|Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
16267461|NCT00883571|Procedure|house advancement flap group|A house flap of healthy tissue was incised to the depth of ischiorectal fat. The flap consisted of skin and subcutaneous tissue. The flap was sufficiently mobilized without undermining its fatty base containing perforating blood vessels. The flap should be loose and easily advanced into the anal canal. When the ''base'' of this house-shaped flap was advanced into the anal canal defect, it was fixed to the top of the excised area with 3/0 Vicryl sutures.
16267462|NCT00883571|Procedure|Rhomboid flap GROUP|A rhomboid flap was incised in ischeorectal fossa and was mobilized without undermining of its fatty base into the anal canal so that the tip of rhomboid flap is sutured to the top of stricured area using vicryl 3/0.
16267463|NCT00883571|Procedure|Y-V anoplasty GROUP|Y-V anoplastyis performed by making a v shaped incision in the perianal skin posteriorly starting from the lower end of the wound resultant from excision of scared area. A V-shaped flap is then dissected with preservation fatty base .The V flap is then advanced into the anal canal so that its tip is sutured to the top of structured area using vicryel 3/0.
16267464|NCT00883558|Drug|Insulin Lispro|
16267465|NCT00883558|Drug|regular human insulin|
16267466|NCT00883558|Drug|recombinant human hyaluronidase PH20|
16267467|NCT00883558|Drug|Insulin glargine|
16267468|NCT00883545|Other|Woman endoscopist|This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.
16267469|NCT00883545|Other|Usual care|This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.
16267470|NCT00883532|Drug|budesonide|budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
16267471|NCT00883532|Drug|surfactant and air (placebo)|receive surfactant and air as control through endotracheal route
16267472|NCT00883519|Behavioral|Interpersonal Psychotherapy for Depressed Adolescents|12 psychotherapy sessions delivered over 16 weeks
16267473|NCT00883519|Behavioral|Interpersonal Psychotherapy for Depressed Adolescents and Parents|12 psychotherapy sessions delivered over 16 weeks
16267474|NCT00883506|Drug|Lisinopril 40 mg Tablet (Zestril) under fed conditions.|
16267475|NCT00883506|Drug|Lisinopril 40 mg Tablet under fasting conditions.|
16267476|NCT00883506|Drug|Lisinopril 40 mg Tablet under fed conditions.|
16267477|NCT00883493|Drug|Quetiapine fumarate XR|Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
16267478|NCT00883493|Drug|Lithium carbonate|Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
16267479|NCT00883480|Drug|Docetaxel|Docetaxel 75 mg/day 1 x 4 cycles
16267482|NCT00883480|Drug|Erlotinib|Erlotinib 150 mg/day x 21 days
16267483|NCT00883467|Procedure|preconditioning|3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
16267484|NCT00883467|Procedure|no preconditioning|no preconditioning
16267485|NCT00883441|Other|Insecticide treated curtains and insecticide treated covers|The study is comparing the introduction of two new vector control tools (insecticide treated curtains and insecticide treated covers) through two different distribution strategies. These tools are curently not in use in the routine programmes of the concerned countries.
16267486|NCT00883428|Other|Set of questionnaires|A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.
16267487|NCT00883415|Drug|Darbepoetin alfa|Subjects will undergo anemia management with darbepoetin after baseline assessment of MGU and will continue for six months with repeat assessment of MGU at completion of protocol
16267488|NCT00883402|Procedure|CEA, CAS|Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)
16267489|NCT00883389|Device|Medical Alert Bracelet|Medical Alert Bracelet alerting health care providers to consider the patient's chronic kidney disease condition when planning care. It also provides a link to a website about safe kidney care (safekidneycare.org)
16267490|NCT00883363|Procedure|Precondition|Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm
16267491|NCT00883350|Behavioral|RIDE e-health application|The RIDE e-Health application utilizes the latest technology to obtain near real-time food intake, body weight, and exercise data from participants living in their natural environment. The application also provides personalized and timely feedback and treatment recommendations based on participants' data. The application relies on the Remote Food Photography Method (Martin, 2009), which was developed by our research team, to collect freeliving food intake data that is transmitted to the researchers in near realtime using a camera and Bluetooth-enabled cell phone. A scale is used to collect daily body weight data from participants and these data are automatically transmitted to the researchers via the same cell phone. The e-Health application collects exercise data from participants and these data are delivered to the researchers via the internet; personalized feedback and treatment recommendations are sent to the participant every 1 to 3 days via the cell phone.
16267492|NCT00883337|Drug|Interferon β-1a|"Sterile preservative-free solution packaged in graduated pre-filled syringes
~Subcutaneous injection
~Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®"
16267493|NCT00883337|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16267494|NCT00883311|Device|BRT-FC-83C|BRT-FC-83C is a topical cream to treat atopic dermatitis. It is applied topically, twice a day, to the atopic dermatitis skin lesion for six weeks.
16267495|NCT00883298|Drug|temozolomide and bevacizumab|oral temozolomide 100 mg/m2 days 1-5 & 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 & 5 every 28-day cycle
16267496|NCT00883272|Dietary Supplement|DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]|a unique enzymatic isolate of the active complex in Tofu
16267497|NCT00883259|Drug|Metformin|850 mg twice daily
16267498|NCT00883259|Other|Placebo|Microcristallyne cellulose 1 table twice daily
16267499|NCT00883246|Device|SilverHawk & TurboHawk Peripheral Plaque Excision System|Removal of atherosclerotic plaque from artery walls.
16267500|NCT00883233|Drug|Adapalene BPO Gel standard daily overnight application|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
16267501|NCT00883233|Drug|Adapalene-BPO 3-hour daily application before bedtime|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
16267502|NCT00883233|Drug|Adapalene-BPO Gel every other day application|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
16267503|NCT00883233|Drug|Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
16267504|NCT00883220|Behavioral|Self-management of urinary catheter|Awareness, self-monitoring, and self-management of urine flow are taught. Focus is on attaining adequate and consistent levels of fluid intake and preventing catheter dislodgement.
16267505|NCT00883207|Behavioral|Psychotherapy|Narrative and dialogical approach for couples
16267506|NCT00883194|Drug|PRF-108|Ropivacaine
16267507|NCT00883194|Drug|Placebo|PRF-108 Placebo
16267508|NCT00883194|Drug|Ropivacaine|Solution
16267509|NCT00883194|Drug|PRF-110|
16267510|NCT00883168|Drug|Placebo|Placebo
16267511|NCT00883168|Drug|azelastineHcl|azelastine hydrochloride 548 mg
16267512|NCT00883168|Drug|fluticasone propionate|fluticasone propionate 200 mcg
16267513|NCT00883168|Drug|azelastine Hcl/fluticasone propionate|azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg
16267514|NCT00883155|Drug|Bupropion HCl 100 mg Tablets (Invamed Inc.)|
16267515|NCT00883155|Drug|Wellbutrin 100 mg Tablets (Glaxo Wellcome)|
16267516|NCT00883129|Drug|Mycophenolate mofetil|24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated
16267517|NCT00883129|Drug|Cyclophosphamide|12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
16267518|NCT00883129|Drug|Placebo|12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years.
16267519|NCT00883116|Drug|Ixabepilone|
16267520|NCT00883116|Drug|Doxorubicin|
16267521|NCT00883116|Drug|Paclitaxel|
16267522|NCT00883103|Drug|2% Lidocaine jelly|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
16267523|NCT00883103|Drug|Plain aqueous gel|Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
16267524|NCT00883090|Biological|FXIII Concentrate (Human)|Subjects will receive approximately 40 U/kg of FXIII every 28 days for 3 doses administered as a bolus intravenous (IV) injection at approximately 250 U/minute.
16267525|NCT00883064|Drug|Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)|
16267526|NCT00883064|Drug|Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)|
16267527|NCT00883051|Drug|Lasmiditan|Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours.
16267528|NCT00883051|Drug|Placebo|Placebo
16267529|NCT00883038|Other|diabetic diet following the DNSG guidelines|The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.
16267530|NCT00883038|Other|low-fat vegetarian diet|The low-fat vegetarian diet (~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.
16267531|NCT00883012|Biological|Trivalent sub-unit influenza vaccine|"Composition per 0.5 ml dose:
~Active substance:
~Split Influenza virus*, inactivated Strains for 2009 Southern hemisphere A/Brisbane/59/2007- like (H1N1) 15 micrograms**, A/Brisbane/10/2007 (H3N2) - like strain (A/Brisbane/10/2007 (IVR-147) 15 micrograms**, B/Florida/4/2006 - like strain (B/Brisbane/3/2007)15 micrograms** Two doses, one month apart"
16267532|NCT00883012|Biological|Saline, 0.5ml|Saline IMI, 0.5ml. Two doses one month apart
16267533|NCT00882999|Drug|LY2127399|Administered via Injection
16267534|NCT00882999|Drug|Placebo|Administered via Injection
16267535|NCT00882973|Drug|Genexol-PM|Cremophor EL-free polymeric micelle of paclitaxel
16267536|NCT00882960|Drug|intravenous fentanyl|An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.
16267537|NCT00882960|Drug|intra-nasal fentanyl|a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management
16267538|NCT00882947|Drug|Ventavis (Iloprost, BAYQ6256)|Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog
16267539|NCT00882934|Other|Induction to efficient treatment|Informative letters.
16267540|NCT00882934|Other|Doubt to the efficacy of treatment|Informative letters.
16267541|NCT00882934|Other|Induction to ineffective treatment|Informative letters
16267542|NCT00882921|Biological|Idursulfase|Patients received idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire Human Genetic Therapies, Inc. or the HOS.
16267543|NCT00882908|Drug|TMC435|TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
16267544|NCT00882908|Drug|Ribavirin (R)|Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
16267545|NCT00882908|Drug|PegIFNα-2a (P)|PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
16267546|NCT00882908|Drug|Placebo|Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
16267547|NCT00882895|Procedure|Stem cell infusion|
16267548|NCT00882895|Procedure|TLI|
16267549|NCT00882895|Drug|Anti-thymocyte globulin|
16267550|NCT00882895|Drug|Solumedrol|
16267551|NCT00882895|Drug|Tacrolimus|
16267552|NCT00882895|Drug|Mycophenolate mofetil|
16267553|NCT00882882|Drug|Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC|
16267554|NCT00882882|Drug|Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC|
16267555|NCT00882882|Drug|GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb|
16267556|NCT00882882|Drug|GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb|
16267557|NCT00882869|Drug|AEG35156 antisense IV infusion|Dose escalation (100, 200 and 300 mg/day) over 2 hr infusion, once weekly over 21 days (Day 1, 8, 15)
16267558|NCT00882869|Drug|Sorafenib|Sorafenib will be administered at 400 mg BID every day
16267559|NCT00882856|Drug|Bisoprolol|"Bisoprolol Vitabalnas 10 mg once daily"
16267560|NCT00882856|Drug|Placebo|placebo
16267561|NCT00882830|Procedure|EMS|EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.
16267562|NCT00882817|Other|Pulmonary Rehabilitation|The intervention group will perform a 6 month pulmonary rehabilitation program which consists of training, patient education, nutrition counseling and psychosocial support. They will be evaluated with some tests for the study.
16267563|NCT00882804|Drug|Hemin infusion|Hemin (Panhematin®, Ovation Pharmaceuticals, Deerfield, IL) will be administered through a large-caliber peripheral vein at a dose of 1.25 mL/kg and at a rate of 60 mL/hour. To enhance stability, Panhematin® will be diluted in ~ 132 mL of 25% albumin to obtain a hemin concentration of 2.4 mg/mL.
16267564|NCT00882804|Drug|placebo infusion|25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.
16267565|NCT00882778|Drug|eptacog alfa (activated)|Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors
16267566|NCT00882765|Dietary Supplement|genistein|Given orally
16267567|NCT00882752|Procedure|molecular analysis|bowel disease
16267568|NCT00882739|Drug|Clopidogrel 300 mg|Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
16267569|NCT00882739|Drug|Clopidogrel 600 mg|Patients will receive a 600 mg clopidogrel loading dose at first medical contact
16267570|NCT00882739|Drug|Clopidogrel 900 mg|Patients will receive a 900 mg clopidogrel loading dose at first medical contact
16267571|NCT00882726|Drug|CNTO 3649 IV (Healthy participants)|Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.
16267572|NCT00882726|Drug|CNTO 3649 SC (Healthy participants)|Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.
16267573|NCT00882726|Drug|CNTO 3649 SC (Diabetic patients)|Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.
16267574|NCT00882726|Drug|Placebo|Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
16267575|NCT00882713|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
16267576|NCT00882700|Drug|Cefdinir 300 mg Capsule (Sandoz, Austria)|
16267577|NCT00882700|Drug|Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)|
16267578|NCT00882687|Drug|Lifitegrast|Ophthalmic Solution
16267579|NCT00882687|Other|Placebo|Ophthalmic Solution
16267580|NCT00882674|Drug|RG1507|16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients
16267581|NCT00882661|Device|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
16267582|NCT00882661|Device|ASSURE Cervical plate and an allograft interbody spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
16267583|NCT00882635|Drug|enoxaparin|"Enoxaparin 0.5 mg/kg IV bolus (Regardless of whether the investigator has chosen to initiate concomitant GP IIb/IIIa antagonist; provision for additional IV enoxaparin to be administered if elapsed time to PCI exceeds 2 hours (from original IV dose) - enoxaparin 0.25 mg/kg IV will be administered At the discretion of the treating physician, if sustained anticoagulation is required then enoxaparin subcutaneously will be administered - enoxaparin 1.0 mg/kg SQ q 12 hours.
~Maintenance dose adjustment for renal insufficiency - creatinine clearance < 30 ml/min, sc enoxaparin should be administered at 1.0 mg / kg / q24 hours. No adjustment of IV dose is required in case of renal insufficiency"
16267584|NCT00882635|Drug|Unfractionated heparin|Unfractionated heparin 70 u/kg IV bolus (consistent with ASSENT 4 PCI) Baseline ACT will be draw at time of sheath insertion - With use of GP IIb/IIIa antagonist additional UFH will be administered to achieve an ACT of ≥200 - 250 seconds If IIb/IIIa is not utilized - additional UFH will be administered to achieve an ACT of ≥250-350 seconds At the discretion of the treating physician if sustained anticoagulation is required:UFH infusion 12/u/kg/hr IV infusion to commence
16267585|NCT00882622|Procedure|Remote Ischemic Preconditioning|RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.
16267586|NCT00882622|Procedure|Control/sham procedure|Sham placement of the blood pressure cuff around the upper limb without inflation.
16267587|NCT00882609|Device|Bone Scan: F18-Fluoride PET/CT or TC-MDP|Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.
16267588|NCT00882596|Device|Accelerated partial breast irradiation|A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient.
16267589|NCT00882583|Drug|Cetuximab|single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
16267590|NCT00882583|Drug|Dasatinib|Oral Dasatinib Days 8 through 64.
16267591|NCT00882583|Drug|Cisplatin|Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
16267592|NCT00882583|Radiation|Radiation Therapy|Standard Radiation Therapy.
16267593|NCT00882570|Drug|Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)|
16267594|NCT00882570|Drug|Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)|
16267595|NCT00882557|Drug|daptomycin|intradialytic: 9 mg/kg during the last 30 minutes of dialysis
16267596|NCT00882557|Drug|daptomycin|6 mg/kg administered after a hemodialysis session
16267597|NCT00882531|Drug|isotretinoin|0.25 mg/kg, 1 per day, 4 month of treatment
16267598|NCT00882531|Drug|placebo|
16267599|NCT00882518|Drug|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|200 mg or 300 mg, oral, single dose
16267600|NCT00882518|Drug|Chlorpromazine|50 mg, oral, double dose
16267601|NCT00882505|Dietary Supplement|vitamin D|Subject will receive vitamin d supplements
16267602|NCT00882505|Other|Placebo|Subject will receive a placebo.
16267603|NCT00882492|Biological|GLP 1|This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)
16267604|NCT00882492|Biological|normal saline solution placebo|This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery
16267605|NCT00882466|Drug|human recombinant erythropoietin|intravenous bolus injection of EPO (50unit/kg)
16267606|NCT00882453|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Intravenous therapy according to product information
16267607|NCT00882440|Drug|losartan potassium|losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
16267608|NCT00882440|Drug|Placebo|Placebo capsule to losartan
16267609|NCT00882440|Drug|Enalapril|Enalapril 20 mg oral tablet taken once daily for 8 weeks
16267610|NCT00882427|Other|enhanced model predictive control algorithm (eMPC)|eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control
16267611|NCT00882414|Drug|FERINJECT® (Ferric carboxymaltose)|FERINJECT® will be administered i.v. into a peripheral vein in the arm. 500 mg FERINJECT® will be diluted to a total volume of 100mL in 0.9% saline for infusion and administered over 15 minutes duration.
16267612|NCT00882414|Drug|Placebo|Placebo will be administered i.v. into a peripheral vein in the arm. A total volume of 100mL 0.9% saline will be administered over 15 minutes duration.
16267613|NCT00882401|Drug|Ergocalciferol (Vitamin D)|ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.
16267614|NCT00882401|Drug|Placebo|Matching placebo at same dose schedule as ergocalciferol
16267615|NCT00882388|Drug|aspirin|aspirin 100 mg qd for 7 days
16267616|NCT00882388|Drug|celecoxib|celecoxib 200 mg bid * 7 days
16267617|NCT00882388|Drug|aspirin + celecoxib|aspirin 100 mg qd + celecoxib 200 mg bid for 7 days
16267618|NCT00882388|Drug|aspirin + clopidogrel|asprin 100 mg qd + clopidogrel 75 mg qd for 7 days
16267619|NCT00882388|Drug|aspirin + clopidogrel + celecoxib|aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
16267620|NCT00882375|Drug|Nicotine|Nicotine administered using novel NRT user instructions
16267621|NCT00882375|Drug|Placebo|Placebo administered using novel NRT user instructions
16267622|NCT00882362|Drug|OPC-14597 (Aripiprazole)|administered orally once daily, 3 to 15 mg daily, 52 weeks
16267623|NCT00882323|Drug|Cyclophosphamide, Fludarabine, Thymoglobulin|"cyclophosphamide (60 mg/kg once daily i.v. on days -8, -7)
~fludarabine (40 mg/m2 once daily i.v. on days -6, -5, -4, -3, -2)
~thymoglobulin (2.5 mg/kg once daily i.v. on days -4, -3, -2)"
16267624|NCT00882310|Drug|Gemcitabine|Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
16267625|NCT00882310|Drug|Docetaxel|Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
16267626|NCT00882310|Drug|Capecitabine|Day 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing
16267627|NCT00882297|Procedure|Echoguided vein puncture|Puncture with echographic visualization of vein in transversal and longitudinal way.
16267628|NCT00882271|Other|Acupuncture|Ten Acupuncture treatments within six weeks
16267629|NCT00882258|Drug|12.5 mg Proellex|12.5 mg Proellex administered orally daily
16267630|NCT00882258|Drug|25 mg Proellex|25 mg Proellex administered orally daily
16267631|NCT00882258|Drug|Placebo|Administered orally daily
16267632|NCT00882245|Other|Vehicle ointment|Topical vehicle cream
16267633|NCT00882245|Drug|Ointment|SRD441 Ointment
16267634|NCT00882232|Device|Cross-linked hyaluronan gel|"Single, transperitoneal injection of 9 mL cross-linked hyaluronan gel into anterior perirectal fat under anesthesia. The gel is injected prior to the start of radiotherapy and is absorbed by the body over several months. It increases the seapartion between the prostate and rectum by 1/3 to 2/3 at the start of radiotherapy."
16267635|NCT00882219|Device|Xience V®|Placement of a Xience V® stent within a restenosed bare metal stent.
16267636|NCT00882206|Drug|cytarabine|"At baseline when peripheral blood draw and bone marrow aspirate performed.
~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg."
16267637|NCT00882206|Drug|decitabine|Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour
16267638|NCT00882206|Drug|doxorubicin hydrochloride|Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes
16267639|NCT00882206|Drug|imatinib mesylate|340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.
16267640|NCT00882206|Drug|methotrexate|**Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
16267641|NCT00882206|Drug|pegaspargase|2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
16267642|NCT00882206|Drug|prednisone|40mg/m2/day divided BID (days 5 - 33)
16267643|NCT00882206|Drug|vincristine sulfate|1.5mg/m2 (max 2 mg) iv push q week (days 5, 12, 19, 26)
16267644|NCT00882206|Drug|vorinostat|Days 1-4, (230 mg/m2)orally divided twice a day (max dose 400 mg daily)
16267645|NCT00882193|Drug|Betaine|Betaine 20 gm/day in 2 divided doses for 48 weeks
16267646|NCT00882193|Drug|Peginterferon alpha 2a|Peginterferon alpha 2a 180mcg/0.5ml by subcutaneous injection weekly for 48 weeks
16267647|NCT00882193|Drug|Ribavirin|Ribavirin 200mg - weight based, 1000 - 1200 mg/day for body weight < or > 75mg in 2 divided doses
16267648|NCT00882180|Drug|ALN-VSP02|IV infusion administered every two weeks
16267649|NCT00882167|Other|CineMRI|CineMRI scan of the abdomen at 1.5 Tesla.
16267650|NCT00882154|Drug|Cefdinir 300 mg Capsule (Sandoz, Austria)|
16267651|NCT00882154|Drug|Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)|
16267652|NCT00882141|Behavioral|Diet modification|Weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months; recommended caloric intake to elicit a weight loss of approximately 0.2-0.4 kg per week
16267653|NCT00882141|Behavioral|Aerobic exercise|Treadmills and other aerobic exercise equipment 3 times a week for 6-9 months, beginning at low levels of VO2max and progressing in duration and intensity to more than 75% VO2max for 45 minutes
16267654|NCT00882115|Drug|Broccoli sprout extract (BSE)|BSE will be ingested by drinking a liquid formula containing 1.25 g BSE in a volume equaling 1 cup daily for 4 consecutive days in the BSE intervention phase.
16267655|NCT00882102|Drug|Decitabine|Decitabine 20 mg/m^2 IV over 1-1/2 hours daily for 5 days.
16267656|NCT00882102|Drug|Gemtuzumab ozogamicin|Gemtuzumab ozogamicin 3 mg/m^2 IV on day 5.
16267657|NCT00882089|Device|Contura catheter|Radiation therapy is delivered to a total dose of 34 Gy in 10 fractions bid over 5-7 days. Each day, the high dose rate iridium-192 brachytherapy treatments are separated by 6 hours. Each radiation treatment takes 15-30 minutes.
16267658|NCT00882076|Drug|Clofarabine|For Treatment Clofarabine will be administered on Days 2-6 at the dose of 20mg/m2 in Cohort 1, 25mg/m2 in Cohort 2 and 30mg/m2 in Cohort 3 and 4 and 10mg/m2 in Cohort 0 (In the event of excessive DLT in Treatment Cohort 1). For Retreatment Clofarabine will be administered on Days 1-4 at the dose of 20mg/m2 in Cohort 1, 25mg/m2 in Cohort 2 and 30mg/m2 in Cohort 3 and 4 and 10mg/m2 in Cohort 0 (In the event of excessive DLT in Retreatment Cohort 1).
16267659|NCT00882076|Drug|Mitoxantrone|For Treatment Mitoxantrone will be administered on Days 1-3 at the dose of 8mg/m2 in Cohort 1, 2, 3 and on Days 1-5 for Cohort 4 and on Days 1-3 8mg/m2 in Cohort 0 (In the event of excessive DLT in Treatment Cohort 1). For Retreatment Mitoxantrone will be administered on Days 1-2 (2 doses) at the dose of 8mg/m2 in Cohort 1, 2 and 3 and on Days 1-4 (4 doses) at the dose of 8mg/m2 in Cohort 4, and on Days 1-2 (2 doses) at the dose of 8mg/m2 in Cohort 0 (In the event of excessive DLT in Retreatment Cohort 1).
16267660|NCT00882076|Drug|Etoposide|For Treatment Etoposide will be administered on Days 1-5 at the dose of 100mg/m2 in Cohort 1, 2, 3, 4 and Cohort 0 (in the event of excessive DLT in Treatment Cohort 1). For Retreatment Etoposide will be administered on Days 1-4 at the dose of 100mg/m2 in Cohort 1, 2, 3, 4 and Cohort 0 (in the event of excessive DLT in Retreatment Cohort 1).
16267744|NCT00881439|Drug|Placebo|Matching Placebo once daily, 6 months
16267745|NCT00881426|Drug|Cefprozil 500 mg Tablets (Sandoz GmbH)|
16267746|NCT00881426|Drug|Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)|
16267661|NCT00882063|Drug|P276-00|Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.
16267662|NCT00882050|Drug|Exenatide|Exenatide to be infused intravenously at 0.27 ng/kg/min (0.066 pmol/kg/min) for a duration of 3 to 6 hours.
16267663|NCT00882050|Drug|Exenatide|Exenatide to be infused intravenously 0.41 ng/kg/min (0.099 pmol/kg/min) for a duration of 3 to 6 hours
16267664|NCT00882050|Drug|Placebo|Intravenous Placebo of normal saline solution to be infused at same rate as drug comparator
16267665|NCT00882024|Drug|Tranilast|150 mg tranilast tablets, bid, 12 weeks
16267666|NCT00882024|Drug|Tranilast|75 mg tablets, bid, 12 weeks
16267667|NCT00882024|Drug|Placebo|Placebo tablets, bid, 12 weeks
16267668|NCT00882011|Other|Latest generation chemotherapies for T-LBL + transplant|"Standard doses of one of the following chemotherapies:
~Holzer
~LSA2-L2 modified
~Stanford regimen
~Hyper CVAD
~Sequential treatments analogous to the ones above mentioned (e.g.: GIMEMA LAL094, others)
~Intensive chemotherapy, ALL-type, MRD oriented (NILG-TLL Clinical Trial)
~Autologous transplant or allogeneic transplant or mini-allogeneic transplant"
16267669|NCT00881998|Procedure|Minimally Invasive Total Hip Arthroplasty|
16267670|NCT00881998|Procedure|Conventional Total Hip Arthroplasty|
16267671|NCT00881985|Device|continuous positive airway pressure|Use CPAP whenever sleep
16267672|NCT00881972|Behavioral|Exercise|walking/running/cycling
16267673|NCT00881959|Device|Puros® Dermis versus Alloderm®|Puros Dermis and Alloderm (both Allograft Tissue Matrix)
16267674|NCT00881946|Drug|GSK21110183|Starting Dose = 25mg once daily with dose escalation until unacceptable toxicity develops
16267675|NCT00881933|Other|Cyclophosphosphamide, TBI|fludarabine (30 mg/m2 once daily i.v. on days -7, -6, -5, -4, -3, & -2) (if body weight < 10 kg or if age < 1 year: 1.33 mg/kg) cyclophosphamide (60 mg/kg once daily i.v. on days -9, & -8) total body irradiation (3G on days -1)
16267676|NCT00881920|Biological|Kappa CD28 T cells|"T cells will be given in a lymphopenic environment utilizing (as needed) lymphodepleting chemotherapy (Cy/Flu) prior to T cell infusion as outlined below:
~Patients who are not lymphopenic may receive 3 daily doses of cyclophosphamide (500mg/m2/day) together with fludarabine (30mg/m2) to induce lymphopenia, finishing at least 24 hours before T cell infusion.
~Patients with lymphopenia due to current drug therapy may be infused at any time starting at least 24 hours after finishing their current cycle of chemotherapy.
~ASCT recipients (relapsed/refractory intermediate grade lymphoma) may be infused 14-60 days after the date of transplant.
~T cell dosing is as follows:
~Group 1: 2x10^7 cells/m^2 CAR-Kappa
~Group 2: 1x10^8 cells/m^2 CAR-Kappa
~Group 3: 2x10^8 cells/m^2 CAR-Kappa"
16267677|NCT00881907|Drug|Triple Antibiotic Paste|ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
16267678|NCT00881907|Drug|Triple Antibiotic Paste|ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
16267679|NCT00881907|Drug|Triple Antibiotic Paste|ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
16267680|NCT00881894|Drug|Rotigotine transdermal patch|Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
16267681|NCT00881868|Drug|clobetasol propionate spray 0.05%|Apply enough product to cover affected areas topically twice daily at least 8 hours apart
16267682|NCT00881868|Drug|Vehicle spray|Apply enough product to cover affected areas topically twice daily at least 8 hours apart
16267683|NCT00881855|Drug|Cefprozil 500 mg Tablets (Sandoz, GmbH)|
16267684|NCT00881855|Drug|Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)|
16267685|NCT00881842|Biological|Trivalent influenza subunit vaccine Influvac|3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
16267686|NCT00881829|Device|Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature|Measurement of physiological parameters.
16267687|NCT00881816|Drug|Liposomal paclitaxel plus capecitabine|All Patients will receive liposomal paclitaxel (with a dose of 60mg/m2,3h,ivgtt,at d1,8,15) and capecitabine (with a dose of 1600mg/m2,bid,po.,at d1-14),each cycle for 4 cycles.
16267688|NCT00881790|Other|Fluoride varnish|the topical application of fluoride varnish to all surfaces of exposed teeth
16267689|NCT00881777|Procedure|Radiofrequency heating of the myocardial infarct scar|Radiofrequency energy is applied to the epicardial surface of the heart using an external generator and a hand-held probe to heat myocardial infarction scar.
16267690|NCT00881777|Procedure|Coronary Artery Bypass Grafting (CABG) surgery|A standard surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. Arteries or veins from elsewhere in the body are grafted to the coronary arteries to bypass atherosclerotic narrowings and improve the blood supply to the coronary circulation supplying the myocardium.
16267691|NCT00881764|Procedure|Inguinal hernia surgery|Non-experimental procedure
16267692|NCT00881764|Procedure|General anesthesia|Non-experimental procedure/treatment
16267693|NCT00881751|Biological|bevacizumab|Given IV
16267694|NCT00881751|Drug|erlotinib hydrochloride|Given orally
16267695|NCT00881751|Drug|sorafenib tosylate|Given orally
16267696|NCT00881738|Drug|Clarithromycin 250 mg Tablets (Geneva, USA)|
16267697|NCT00881738|Drug|Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)|
16267698|NCT00881725|Drug|Metformin|500mg tablets t.i.d. for 4-12 weeks prior to Radical Prostatectomy
16267699|NCT00881712|Radiation|PET positive nodal disease measuring 15 mm or greater|Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.
16267700|NCT00881712|Radiation|PET positive nodal disease measuring less than 15 mm|Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.
16267701|NCT00881712|Radiation|Patients considered resectable|Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed.
16268095|NCT00878800|Drug|Doxorubicin|Administered in combination with PXD101 (BelDox)
16267702|NCT00881699|Behavioral|HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you|Eight weekly 2-hour HIV risk reduction intervention sessions, with three weekly 2-hour booster sessions completed 6 months after the initial intervention. Specific goals of the intervention are to (1) increase information about HIV risk behaviors and safer sex options; (2) increase identification of personal risk of HIV and enhance the motivation to engage in safer sex behaviors; and (3) enhance skills to achieve safer sex, particularly negotiating safer sex, using condoms, and communicating within a relationship.
16267703|NCT00881699|Behavioral|Health Promotion Intervention|Eight weekly 2-hour health promotion intervention sessions with three weekly 2-hour booster sessions completed 6 months after the initial intervention. Specific goals of the intervention are to (1) increase information about health issues specific to psychiatric patients, (2) increase identification of personal health risks and enhance motivation to engage in healthier behaviors, and (3) enhance skills to achieve healthier behaviors.
16267704|NCT00881686|Drug|adenosine|1.5mg/Kg adenosine will be administered intravenously before surgery
16267705|NCT00881673|Drug|AL38583 Ophthalmic Solution|Topical ophthalmic
16267706|NCT00881673|Drug|Maxidex|Topical ophthalmic
16267707|NCT00881673|Drug|Vehicle|AL38583 Vehicle
16267708|NCT00881660|Device|Goldballoon Detachable Balloon and delivery microcatheter|"Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as extremely severe cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center."
16267709|NCT00881647|Other|Cognitive Behavioral Treatment for Insomnia (CBT-I)|CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
16267710|NCT00881634|Drug|Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)|
16267711|NCT00881634|Drug|Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)|
16267712|NCT00881621|Drug|Lapatinib and Capecitabine|Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
16267713|NCT00881608|Drug|Placebo|Placebo, 1 capsule daily for five days
16267714|NCT00881608|Drug|Proellex|Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
16267715|NCT00881595|Drug|Chemoradiotherapy Temozolomide|Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks.Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.
16267716|NCT00881595|Radiation|Proton therapy|50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)
16267717|NCT00881595|Procedure|Proton Chemoradiotherapy followed by surgery|Proton Chemoradiotherapy followed by surgery. Resection of tumor at 4-6 weeks post-treatment.
16267718|NCT00881582|Drug|Pegylated interferon alfa-2a plus ribavarin|PEG-interferon alfa-2a and ribavirin. Pegylated interferon alfa-2a - standard dose; plus ribavirin - standard dose (determined by creatinine clearance); for 24 to 48 weeks (genotypes 1 & 4: 48 weeks; genotypes 2 & 3: 24 weeks)
16267719|NCT00881569|Drug|CS-7017|CS-7017 administered orally, twice daily continuously for 6 weeks
16267720|NCT00881556|Drug|Palifermin|60 mcg/kg/day for 6 days
16267721|NCT00881556|Drug|Fludarabine|30 mg/m2 IV x 1 for 6 days
16267722|NCT00881556|Drug|Busulfan|4 mg/kg/day IV divided BID for 4 days
16267723|NCT00881556|Drug|Lorazepam|0.02-0.05 mg/kg for 5 days
16267724|NCT00881556|Drug|Alemtuzumab|20 mg/m2 IV for 5 days
16267725|NCT00881556|Drug|Tacrolimus|0.03mg/kg/24 hours as continuous infusion for 4 days
16267726|NCT00881543|Drug|Dipeptidyl Peptidase IV inhibitors|Dosage 100 mg each day, once a day, 2 months
16267727|NCT00881530|Drug|BI 10773|BI 10773 high dose once daily
16267728|NCT00881530|Drug|Metformin|open label comparator
16267729|NCT00881530|Drug|BI 10773|BI 10773 low dose once daily
16267730|NCT00881530|Drug|Sitagliptin|open label comparator
16267731|NCT00881517|Drug|HCMV-specific hyperimmune globulin (Cytotect®)|100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.
16267732|NCT00881517|Drug|Isotonic solution of sodium chloride (placebo)|2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination
16267733|NCT00881504|Drug|"Bevacizumab in combination with modified FOLFOX6."|Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks
16267734|NCT00881491|Drug|Double Antibiotic Paste|ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
16267735|NCT00881491|Drug|Triple Antibiotic Paste|ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
16267736|NCT00881491|Drug|Mineral Trioxide Aggregate|standard material providing an apical barrier
16267737|NCT00881478|Other|Nutrition counseling + portion control tool|Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool
16267738|NCT00881478|Other|Nutrition counseling|Nutrition counseling with registered dietician
16267739|NCT00881465|Behavioral|Cognitive-behavioral therapy|Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.
16267740|NCT00881465|Behavioral|Wait-list control|Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
16267741|NCT00881452|Drug|CM-AT|Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
16267742|NCT00881452|Drug|Placebo|Single unit dose powder of non-active substance administered 3 times per day for 90 days
16267743|NCT00881439|Drug|Aliskiren|Oral, 300 mg, once daily, 6 months
16267747|NCT00881413|Drug|Esomeprazole|Intravenous esomeprazole (Nexium®, AstraZeneca, Sodertalje, Sweden) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral esomeprazole 40 mg (Nexium®, AstraZeneca, Sodertalje, Sweden) for 2 months
16267748|NCT00881413|Drug|Pantoprazole|After successful endoscopy, intravenous pantoprazole (Pantoloc®, Nycomed GMBH, Konstanz, Germany) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral pantoprazole 40 mg (Pantoloc®, Nycomed GMBH, Oranienburg, Germany) for 2 months
16267749|NCT00881400|Drug|Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)|
16267750|NCT00881400|Drug|Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)|
16267751|NCT00881387|Biological|rituximab|Given IV
16267752|NCT00881387|Drug|gemcitabine hydrochloride|Given IV
16267753|NCT00881387|Drug|vinorelbine ditartrate|Given IV
16267754|NCT00881374|Drug|LACTIC ACID(ND)|Dermacyd Infantile (Lactic Acid)
16267755|NCT00881361|Drug|systemic chemotherapy|
16267756|NCT00881361|Procedure|axillary lymph node dissection|
16267757|NCT00881361|Procedure|neoadjuvant therapy|
16267758|NCT00881361|Procedure|sentinel lymph node biopsy|
16267759|NCT00881361|Procedure|therapeutic conventional surgery|
16267760|NCT00881361|Procedure|ultrasound imaging|
16267761|NCT00881348|Drug|LACTIC ACID(ND)|Dermacyd infantile (Lactic Acid)
16267762|NCT00881335|Device|flutter mucus clearance device|five minutes every sessions, three sessions per day
16267763|NCT00881322|Dietary Supplement|BC-130 (Gas Defense)|"Product Dosing:
~Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
~Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish."
16267764|NCT00881322|Dietary Supplement|Placebo|"Product Dosing:
~Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
~Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD&C yellow #5 Lake, FD&C blue #1 Lake, FD&C red #46 Lake and vegetable capsule"
16267765|NCT00881309|Drug|Tripterygium|TW 90mg/d
16267766|NCT00881296|Drug|gemcitabine and carboplatin|Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles.
16267767|NCT00881296|Drug|Gemcitabine|Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles
16267768|NCT00881270|Drug|LACTIC ACID(ND)|Dermacyd Infantile (LACTIC ACID)
16267769|NCT00881257|Device|GRST Peripheral Catheter System|Treatment to dilate stenoses and reduce plaque in treated vessels
16267770|NCT00881244|Drug|AS1411|I.v. 4-7 days, 1-40 mg/kg/day
16267771|NCT00881231|Drug|Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)|
16267772|NCT00881231|Drug|Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)|
16267773|NCT00881218|Drug|Regadenoson|Regadenoson 400 micrograms will be administered IV bolus via an antecubital cannula.
16267774|NCT00881205|Drug|Rivastigmine transdermal patch|Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color.
16267775|NCT00881205|Drug|Placebo|Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and color of rivastigmine patches.
16267776|NCT00881192|Procedure|IABP|preoperative IABP placement
16267777|NCT00881179|Drug|Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)|
16267778|NCT00881179|Drug|Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)|
16267779|NCT00881166|Drug|MP-470 + topotecan|Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
16267780|NCT00881166|Drug|MP-470 + docetaxel|Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
16267781|NCT00881166|Drug|MP-470 + erlotinib|150 mg PO once daily at least 1 hour before or 2 hours after eating
16267782|NCT00881166|Drug|MP-470 + paclitaxel/carboplatin|Paclitaxel 200 mg/m2 IV infusion over 3 hours followed by carboplatin IV infusion over 1 hour to a target AUC of 6 mg∙min/mL on Day 1
16267783|NCT00881166|Drug|MP-470 + carboplatin/etoposide|Carboplatin IV infusion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100 mg/m2 IV infusion over 2 hours on Days 1-3
16267784|NCT00881153|Drug|Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)|
16267785|NCT00881153|Drug|Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)|
16267786|NCT00881140|Drug|mifepristone vaginal tablets|Daily use of 10 mg administrated per vagina for 3 months
16267787|NCT00881127|Drug|Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)|
16267788|NCT00881127|Drug|Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)|
16267789|NCT00881114|Drug|Cisplatin|Intensity modulated radiation therapy with concurrent chemotherapy. Cisplatin will be administered at a dose of 100 mg/m2 during weeks 1, 4, and 7 of radiation therapy. Post treatment neck dissection will be performed if clinically indicated.
16267790|NCT00881114|Drug|Cetuximab|Intensity modulated Radiation Therapy with concurrent chemotherapy. Cetuximab will be administered beginning at a dose of 400 mg/m2 the week before radiation commences, then at a dose of 250 mg/m2 weekly during weeks 1 to 7. Post treatment neck dissection will be performed if clinically indicated.
16267791|NCT00881101|Drug|Liposomal paclitaxel|All Patients will receive liposomal paclitaxel (starting at a dose of 190mg/m2,3h,ivgtt,at d1)each cycle for 1 cycle.
16267792|NCT00881088|Drug|Nadroparin|nadroparin 0,3 cc once daily during immobilization period
16267793|NCT00881088|Drug|Fondaparinux|Fondaparinux 2,5 mg daily during immobilization period
16267794|NCT00881075|Drug|SeeMore(TM)|single dose intravenous injectable
16267795|NCT00881062|Drug|Proellex|A single oral dose administered after at least a 10 hour fast
16267796|NCT00881049|Drug|Imatinib (Gleevec)|Imatinib will be given for enrolled patients to investigate efficacy and safety
16268096|NCT00878787|Device|Transcranial magnetic stimulation|
16267797|NCT00881023|Procedure|Microfracture|The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue
16267798|NCT00881023|Device|Cartilage Autograft Implantation System|A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region
16267799|NCT00881010|Behavioral|Telephone Intervention|Automated Telephone Interactive Voice Response (IVR) system taking approximately 5 minutes, 2 times week for 10 weeks, to rate pain and symptoms.
16267800|NCT00881010|Behavioral|Questionnaires|Surveys approximately 1 hour each at 2 regularly scheduled clinic visits to rate pain and symptoms. Regardless of group, all symptoms are to be reported.
16267801|NCT00880997|Drug|Doxazosin|"Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
~Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
~Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
~Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17."
16267802|NCT00880997|Other|Placebo|Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.
16267803|NCT00880984|Device|Compression Anastomosis Ring: CAR™ 27|Creation of anastomosis in colorectal surgeries using CAR™ 27
16267804|NCT00880971|Radiation|Postoperative 3D-CRT or IMRT|Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
16267805|NCT00880958|Dietary Supplement|Mixture of various probiotics and fermentation products|
16267806|NCT00880958|Dietary Supplement|Placebo|
16267807|NCT00880932|Behavioral|Electronic Alert|
16267808|NCT00880919|Drug|quetiapine extended-release|Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
16267809|NCT00880919|Drug|Placebo|Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
16267810|NCT00880906|Procedure|Esophageal dilation|The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.
16267811|NCT00880906|Drug|Steroid and Proton Pump Inhibitor Therapy|
16267812|NCT00880893|Biological|CYD Dengue vaccine|0.5 mL, Subcutaneous on Day 0, Months 6 and 12
16267813|NCT00880893|Biological|NaCl + influenza virus or hepatitis A vaccine|0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
16267814|NCT00880880|Other|e-PAQ-PF|Participants will fill out the e-PAQ-PF prior to their clinic visit. The e-PAQ-PF has 4 dimensions (urinary, bowel, vaginal, sexual) and asks about symptoms severity, bother of symptoms, and impact on quality of life. A copy of the results will be given to their clinician and the participant.
16267815|NCT00880867|Drug|Poly-ICLC|An accessible site of disease (lymph node, cutaneous, subcutaneous, etc.) will be selected by the principal investigator. Patients will then receive two doses of low dose irradiation (2 Gy per day) to that single site on days 1 and 2. Intratumorally or peritumorally Poly-ICLC will be dosed on days 3 and 4 by the physician during weeks 1, 2, 3, 4, and 8.
16267816|NCT00880854|Drug|BCG and CP-675,206|"Dose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15
~Dose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15
~Dose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15
~Dose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15"
16267817|NCT00880841|Drug|Buprenorphine / Naloxone|oral formulation of buprenorphine / naloxone
16267818|NCT00880828|Other|FIR cervical collar with Acetaminophen|FIR cervical collar with Acetaminophen QID/PRN for 4 weeks
16267819|NCT00880828|Other|Conservative cervical collar with Acetaminophen|Conservative cervical collar with Acetaminophen QID/PRN for 4 weeks
16267820|NCT00880828|Drug|Acetaminophen only|Acetaminophen QID/PRN for 4 weeks
16267821|NCT00880815|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo ASCT
16267822|NCT00880815|Biological|Anti-Thymocyte Globulin|Given IV
16267823|NCT00880815|Drug|Bendamustine|Given IV
16267824|NCT00880815|Biological|Filgrastim|Given IV
16267825|NCT00880815|Drug|Fludarabine|Given IV
16267826|NCT00880815|Drug|Methotrexate|Given IV
16267827|NCT00880815|Biological|Rituximab|Given IV
16267828|NCT00880815|Drug|Tacrolimus|Given IV and PO
16267829|NCT00880789|Biological|CMV/AdV specific T cells|CTL Dose Given from Day +30 post SCT (stem cell transplant). For the trial, two patients are allocated in each cohort and are followed for 30 days post IV injection of transduced T-cells for evaluation of DLTs. A maximum 18 patients will be accrued into each group. The final MTD will be the dose with probability closest to the target toxicity rate at these termination points. The trial continues until a minimum of 12 patients have been treated. The trial will stop when the maximum 18 patients have been treated, or when six patients have been treated at the current MTD. We therefore expect to enroll between 12-18 patients into this trial.
16267830|NCT00880763|Drug|Vaniprevir|Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
16267831|NCT00880763|Drug|Pegylated Interferon (peg-IFN)|Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
16267832|NCT00880763|Drug|Ribavirin|Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
16267833|NCT00880763|Drug|Comparator: Placebo|Placebo to vaniprevir oral capsule twice daily for 28 days
16267834|NCT00880750|Drug|Lanthanum carbonate Granule Formulation|3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)
16267835|NCT00880750|Drug|Lanthanum carbonate Chewable Tablets (Fosrenol)|3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)
16267836|NCT00880724|Device|IBV Valve|Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
16267837|NCT00880698|Biological|RotaTeq|2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose
16267838|NCT00880698|Biological|Placebo|2 mL solution
16267839|NCT00880685|Drug|Memantine|10-30mg, daily for 8 weeks
16267840|NCT00880672|Drug|dutasteride|5mg, oral, daily, 2-4 weeks
16267841|NCT00880659|Behavioral|Soap|Promotion of handwashing with soap
16267842|NCT00880646|Dietary Supplement|Oolong tea containing L-arabinose and indigestible dextrin|
16267843|NCT00880646|Dietary Supplement|Oolong tea (Placebo)|
16267844|NCT00880620|Drug|Placebo|Placebo
16267845|NCT00880620|Drug|IPX066 95 mg LD|IPX066 capsule containing 95 mg LD/23.75 mg CD
16267846|NCT00880620|Drug|IPX066 145 mg LD|IPX066 capsule containing 145 mg LD/36.25 mg CD
16267847|NCT00880620|Drug|IPX066 195 mg LD|IPX066 capsule containing 195 mg LD/48.75 mg CD
16267848|NCT00880620|Drug|IPX066 245 mg LD|IPX066 capsule containing 245 mg LD/61.25 mg CD
16267849|NCT00880607|Drug|Intrathecal morphine|Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
16267850|NCT00880607|Drug|Extended Release Epidural Morphine|DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
16267851|NCT00880594|Drug|Desipramine|"Desipramine 25 mg/day administered in the evening. Dosing may be increased dependent upon side-effects and clinical response to a maximum of 100 mg/day. Absent significant side-effects, all patients are increased at the one week visit to 50 mg/day at bedtime if they have not achieved a report of Adequate relief. Thereafter, up to week 4, the daily desipramine dose may be increased weekly by 25 mg up to the 100 mg/d maximum."
16267852|NCT00880581|Drug|PF-3512676|18 mg injection
16267853|NCT00880581|Radiation|Local radiotherapy|2 gray (2 Gy) on each of Days 1 and 2
16267854|NCT00880568|Drug|MK-1496|MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle
16267855|NCT00880568|Drug|MK-1496|MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle
16267856|NCT00880542|Drug|sorafenib|Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy.
16267857|NCT00880542|Drug|Ifosfamide|Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy.
16267858|NCT00880529|Device|ON-Q bupivicaine administration|continuous subcutaneous bupivicaine drip
16267859|NCT00880529|Drug|IV opioid administration|Patient controlled analgesia with IV narcotics
16267860|NCT00880490|Drug|Inhaled PT005|single dose, inhaled
16267861|NCT00880490|Drug|Inhaled PT005|single dose, inhaled
16267862|NCT00880490|Drug|Inhaled PT005|single dose, inhaled
16267863|NCT00880490|Drug|Inhaled placebo|single dose, inhaled
16267864|NCT00880490|Drug|Formoterol Fumarate 12 mcg (Foradil Aerolizer)|single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
16267865|NCT00880477|Biological|DTPa-HBV-IPV/Hib vaccine|Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
16267866|NCT00880477|Biological|DTPa-IPV/Hib vaccine|Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
16267867|NCT00880477|Biological|EngerixTM-B|The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
16267868|NCT00880464|Biological|Autologous, Lethally Irradiated Breast Cancer Cells|Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
16267869|NCT00880412|Drug|EHT 0202 etazolate|In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
16267870|NCT00880412|Drug|Placebo|In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
16267871|NCT00880399|Drug|orvepitant|Neurokinin-1 (NK-1) antagonist
16267872|NCT00880399|Other|placebo|inactive placebo to match orvepitant 30 and 60 mg dosage forms
16267873|NCT00880386|Drug|Losartan|50 mg Losartan will be taken daily by subjects for 24 weeks
16267874|NCT00880373|Drug|Ibuprofen|Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
16267875|NCT00880373|Drug|Placebo|Matching placebo three times daily for 4 days
16267876|NCT00880373|Drug|Diamorphine or Morphine|Diamorphine or Morphine by PCA
16267877|NCT00880360|Drug|Ontak|Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
16267878|NCT00880347|Device|Blood sampling|Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile. sAPPalpha levels will be also dosed. Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
16267879|NCT00880334|Drug|Docetaxel|Given intravenously on Day 1 of each 21-day cycle
16267880|NCT00880334|Drug|vandetanib|taken orally once a day, every day
16267881|NCT00880334|Drug|Placebo|Taken orally once a day every day
16267882|NCT00880321|Drug|GSK2118436|Dose escalation with GSK2118436 may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached.
16267883|NCT00880321|Drug|GSK2118436|Part 2 will use the recommended Part 2 dose of GSK2118436 identified during Part 1 of the study. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.
16268097|NCT00878774|Biological|ToleroMune Ragweed|ToleroMune Ragweed dose 1x4 administrations 2 weeks apart
16267884|NCT00880321|Drug|Midazolam|Midazolam will be administered alone and with GSK2118436 in a sub-set of subjects in Part 2 to study the effect of GSK2118436 on CYP3A using midazolam as a probe.
16267885|NCT00880308|Drug|LDE225|
16267886|NCT00880295|Procedure|endoscopic carpal tunnel release|endoscopic surgery, which is standard of care for carpal tunnel release
16267887|NCT00880295|Procedure|open carpal tunnel release|open surgery, which is standard of care for carpal tunnel release
16267888|NCT00880282|Biological|cixutumumab|Given IV
16267889|NCT00880282|Drug|temsirolimus|Given IV
16267890|NCT00880282|Other|pharmacological study|Correlative studies
16267891|NCT00880282|Other|laboratory biomarker analysis|Correlative studies
16267892|NCT00880269|Drug|Panobinostat/LBH589|
16267893|NCT00880256|Behavioral|mindfulness-based stress reduction|An 8-week course in mindfulness training
16267894|NCT00880243|Drug|GM-CSF|"Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.
~Randomiization 2: Consolidation high dose AraC versus consolidation EMA"
16267895|NCT00880230|Device|Scuba Iliac Stent System|The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
16267896|NCT00880217|Drug|Atomoxetine 80 mg/d|40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
16267897|NCT00880217|Drug|Placebo|Placebo capsule once daily for 42 days
16267898|NCT00880217|Drug|OROS methylphenidate HCl 54 mg/d|36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
16267899|NCT00880217|Drug|JNJ-31001074 3 mg/d|3-mg capsule once daily for 42 days
16267900|NCT00880217|Drug|JNJ-31001074 1 mg/d|1-mg capsule once daily for 42 days
16267901|NCT00880217|Drug|JNJ-31001074 10 mg/d|10-mg capsule once daily for 42 days
16267902|NCT00880204|Behavioral|ESS-EMCH training|"The trainings of the ESS-EMCH programme are based on two well-tried and tested structured training methodologies of Advanced Pediatric Life Support (APLS) and Management of Obstetric Emergencies and Trauma (MOET)."
16267903|NCT00880191|Drug|dexamethasone|Given orally
16267904|NCT00880191|Drug|gabapentin|Given orally
16267905|NCT00880191|Other|placebo|Given orally
16267906|NCT00880178|Drug|Simvastatin and Extended-Release niacin|Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
16267907|NCT00880178|Drug|Simvastatin|Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
16267908|NCT00880165|Device|Continuous positive airway pressure apparatus|Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.
16267909|NCT00880152|Behavioral|Mindfulness-based stress reduction|An 8-week course in mindfulness training
16267910|NCT00880139|Procedure|Blood sampling|Determination of cytokine plasma levels (ELISA)
16267911|NCT00880139|Procedure|Noninvasive measurement of systemic hemodynamics|performed once
16267912|NCT00880139|Procedure|Visual acuity assessment|ETDRS charts
16267913|NCT00880139|Device|Blue field entoptic technique (Blue field stimulator, BFS-2050)|performed once
16267914|NCT00880139|Procedure|Ophthalmic examination and fundus photography|7 + 1 standard fields
16267915|NCT00880139|Device|Retinal Vessel Analyzer (DVA)|Assessment of retinal vessel reactivity to stimulation with flickering light
16267916|NCT00880139|Device|High resolution optical coherence tomography (OCT)|performed once
16267917|NCT00880126|Behavioral|Community Development Teams|CDTs bring together counties who are implementing a new practice
16267918|NCT00880113|Procedure|Non-contrast CT, CT-perfusion and CT-angiography|Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).
16267919|NCT00880100|Drug|Ultrase® MT12|Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.
16267920|NCT00880087|Procedure|Therapeutic Hypothermia|Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.
16267921|NCT00880087|Procedure|Therapeutic Normothermia|Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
16267922|NCT00880074|Radiation|PET Scan|3 Positron Emission Tomography (PET) scans performed 60-90 minutes after intravenous injection of FLT: 1) within 2 weeks before day 1 of chemotherapy treatment; 2) day 6-7 of chemotherapy treatment; and,3) at end of chemotherapy treatment, day 19-20.
16267923|NCT00880074|Drug|FLT|FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan. Dosage of FLT in the range between 1 and 10 mCi.
16267924|NCT00880061|Drug|IL13-PE38QQR|
16267925|NCT00880048|Drug|orvepitant|neurokinin-1 antagonist
16267926|NCT00880048|Other|Placebo|Placebo to match orvepitant 30 mg and 60 mg
16267927|NCT00880035|Device|MP3 music program listening|3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)
16267928|NCT00880022|Device|Flexitouch System|( 10 to 30 treatments depending on group assignment)
16267929|NCT00880009|Drug|Bosutinib|400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
16267930|NCT00880009|Drug|Letrozole|2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
16268542|NCT00875420|Drug|RAD1901|50 mg Oral once a day for 28 days.
16267931|NCT00880009|Drug|Letrozole|2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
16267932|NCT00879996|Drug|Methadone|Oral, 10-60 mg per day, 2-4 times per day, 6 months
16267933|NCT00879996|Drug|Buprenorphine/naloxone|Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
16267934|NCT00879983|Drug|azithromycin (Zithromax)|"a single dose of azithromycin ER 2g
~3-day regimen of azithromycin tablet 500mg"
16267935|NCT00879983|Drug|azithromycin (Zithromax)|"3-day regimen of azithromycin tablet 500mg
~a single dose of azithromycin ER 2g"
16267936|NCT00879970|Drug|pioglitazone|Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.
16267937|NCT00879970|Drug|rosiglitazone|Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.
16267938|NCT00879970|Drug|placebo|Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.
16267939|NCT00879970|Dietary Supplement|Vitamin D|Vitamin D factor intervention
16267940|NCT00879970|Dietary Supplement|Placebo|Vitamin D factor intervention
16267941|NCT00879957|Drug|heparin|Heparin will be added to PICC infusions at a dose of 0.5 units heparin per milliliter of intravenous fluid/parenteral nutrition.
16267942|NCT00879957|Drug|No heparin|In the no heparin group, the subjects will not receive heparin as an additive to their PICC infusions.
16267943|NCT00879944|Other|Blood pressure|Blood pressure will be measured once while patient is seated
16267944|NCT00879944|Other|Height|Height will be measured in centimeters at the time of enrollment
16267945|NCT00879944|Other|Weight|Weight will be measured in kilograms at enrollment
16267946|NCT00879944|Other|BMI|Body Mass Index (BMI) will be calculated from a subject's height and weight
16267947|NCT00879944|Other|Waist Circumference|Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
16267948|NCT00879931|Drug|Methylprednisolone|Methylprednisolone
16267949|NCT00879931|Drug|Placebo|Placebo (NaCl 0.9%)
16267950|NCT00879918|Drug|Deuterated nicotine and cotinine|used as a marker for pharmacokinetic studies
16267951|NCT00879905|Drug|HSP990|
16267952|NCT00879892|Drug|xenon|Gas, 24 hour inhalation, en tidal target concentration 40%
16267953|NCT00879892|Other|Hypothermia|24 hour, target core temperature 33
16267954|NCT00879879|Drug|losartan|50 mg losartan taken daily by mouth in capsule form for 1 year
16267955|NCT00879866|Biological|EMD 521873|After local irradiation (5 x 4 Gy) given over 5 consecutive days and 2 treatment free days cohorts of 3-6 subjects will receive EMD 521873 (as a 1h-infusion) on 3 consecutive days in 3-week cycles at dose levels of 0.15, 0.30, and 0.45 mg/kg, respectively.
16267956|NCT00879853|Behavioral|Interpersonal Therapy|
16267957|NCT00879827|Biological|Pediarix TM, Infanrix penta TM|The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
16267958|NCT00879827|Biological|Hiberix TM|The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
16267959|NCT00879814|Biological|rLP2086 vaccine or control|intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
16267960|NCT00879814|Biological|rLP2086 vaccine or control|intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
16267961|NCT00879814|Biological|rLP2086 vaccine or control|intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
16267962|NCT00879814|Biological|rLP2086 vaccine or control|intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
16267963|NCT00879788|Drug|Ramipril 10mg capsules|
16267964|NCT00879775|Drug|Caffeine|Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.
16267965|NCT00879775|Drug|Normal saline|Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
16267966|NCT00879762|Biological|IMVAMUNE® High Dose|IMVAMUNE® Vaccinia Vaccine, undiluted, delivered by subcutaneous route on Day 0 at high dose 5×10^8 TCID50 (5×10^8 TCID50 per 1.0 mL dose - administered as 2 x 0.5 mL.
16267967|NCT00879762|Drug|Placebo|0.5 mL injection of saline placebo administered with vaccine on Day 0 (Group B) or single saline placebo dose (single 0.5 mL injection) on Day 28 (Group A).
16267968|NCT00879762|Biological|IMVAMUNE® Standard Dose|IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route on Day 0 and 28 at standard dose (diluted with saline by study pharmacist to (1×10^8 tissue culture infectious dose 50 [TCID50] per 0.5 mL dose)
16267969|NCT00879749|Biological|9 micrograms Nexvax2|9 micrograms, weekly intra-dermal injection, 3 week duration
16267970|NCT00879749|Biological|30 micrograms Nexvax2|30 micrograms, weekly intra-dermal injection, 3 week duration
16267971|NCT00879749|Biological|90 micrograms Nexvax2|90 micrograms, weekly intra-dermal injection, 3 week duration
16267972|NCT00879749|Biological|60 micrograms Nexvax2|60 micrograms, weekly intra-dermal injection, 3 week duration
16267973|NCT00879749|Biological|Up to 900 micrograms Nexvax2|Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
16267974|NCT00879749|Other|Placebo|100 microlitres 0.9% sterile sodium chloride for injection
16267975|NCT00879736|Behavioral|THT PACE Training|Patient training
16267976|NCT00879736|Behavioral|THT PACE Training|Patient training
16267977|NCT00879736|Other|placebo|
16267978|NCT00879723|Dietary Supplement|Vitamin and Mineral supplementation|"IV - 2x per day given 2 - 12 hours apart. A.M. solution - Infuvite multivitamin with minerals, Selenium 200mcg, Zinc 30mg, Vitamin B1 100mg and Vitamin C 500mg. P.M. solution - Cuperic Chloride 9mg (provides Copper 3.36mg) and Vitamin C 500mg. Each fluid solution will run for 4 hours.
~Enteral (oral) 2 x per day given 2 - 12 hours apart. A.M. dose - multivitamin with minerals, Selenium 200mcg, Zinc 30mg, Vitamin B1 100mg and Vitamin C 500mg. P.M. dose - Copper 4mg and Vitamin C 500mg."
16268054|NCT00879086|Drug|ixabepilone|"Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.
~The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment."
16268098|NCT00878774|Biological|Placebo|Placebo comparator, 1x4 administrations 2 weeks apart
16267979|NCT00879710|Drug|simvastatin or ezetimibe|Subjects will be started on either simvastatin or ezetimibe (we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist.
16267980|NCT00879697|Behavioral|Walking Training|The Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds of each exercise bout.
16267981|NCT00879697|Behavioral|Strength Training|The strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-min interval between sets and exercises.
16267982|NCT00879684|Biological|CVX-060|Weekly, intravenous dose
16267983|NCT00879671|Dietary Supplement|lutamax (leutein)|leutein 20 mg for 3 months, then lutein 10 mg
16267984|NCT00879671|Dietary Supplement|placebo|Placebo capsules identical in taste and appearance
16267985|NCT00879658|Drug|BAF312|
16267986|NCT00879658|Drug|Placebo|
16267987|NCT00879645|Drug|Sodium Sulfide|Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours
16267988|NCT00879645|Drug|Sodium Sulfide|Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
16267989|NCT00879645|Drug|Sodium Sulfide|Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
16267990|NCT00879645|Drug|Sodium Sulfide|Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
16267991|NCT00879619|Drug|sunitinib malate|Given PO
16267992|NCT00879619|Drug|docetaxel|Given IV
16267993|NCT00879619|Drug|prednisone|Given PO
16267994|NCT00879606|Drug|ALT-836|In the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes. In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes.
16267995|NCT00879606|Drug|Placebo|In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes.
16267996|NCT00879593|Device|PtcCO2|Nocturnal assessment will be performed during the initial polysomnography (and at 6 months) with a combined PtcCO2/pulse oxymetry TOSCA500 Radiometer monitoring evaluating different physiological parameters.
16267997|NCT00879554|Biological|CVX-045|Weekly, intravenous dose
16267998|NCT00879541|Biological|Biostate® [SP]|Single bolus intravenous dose of 50 IU/kg
16267999|NCT00879541|Biological|Biostate® [SP]|The dose is dependent on the reason for use and may consist of repeated bolus doses as required to manage haemophilia condition.
16268000|NCT00879541|Biological|Biostate® [RP]|Single bolus intravenous dose of 50 IU/kg.
16268001|NCT00879528|Other|Patients with negative PET after salvage therapy|"All patients included in the study will treat with a salvage scheme according to each center.
~After the end of salvage therapy, consolidation depends on the outcome of PET:
~PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells."
16268002|NCT00879528|Other|Patients with positive PET after salvage therapy|"All patients included in the study will treat with a salvage scheme according to each center.
~After the end of salvage therapy, consolidation depends on the outcome of PET
~PET positive, the consolidation therapy consists of 2 phases:
~phase1:common to all consists in a series of high-dose chemotherapy with Melphalan 200 mg/sqm, followed by reinfusion of autologous peripheral stem cells
~phase2:depends on the availability of a compatible donor. If there is a donor, the patient will continue with an allogeneic transplant preceded by a reduced intensity conditioning.
~If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells."
16268003|NCT00879489|Biological|Dendritic Cell Vaccination|Autologous dendritic cells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally.
16268004|NCT00879476|Drug|Ramipril 10mg capsules|
16268005|NCT00879463|Procedure|Brain tissue oxygen saturation monitoring|Brain tissue oxygen saturation monitoring with infrared spectrophotoscopy
16268006|NCT00879463|Procedure|Transfusion according to the anesthesiologist's judgement|Transfusion if hemoglobin is between 5.5-7 mg/dl
16268007|NCT00879450|Other|Booklet|booklet given to parents for home exercises
16268008|NCT00879437|Drug|Valproic acid|"Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT.
~Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml"
16268009|NCT00879437|Drug|Bevacizumab|All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.
16268010|NCT00879437|Radiation|Radiation therapy|Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks.
16268011|NCT00879424|Dietary Supplement|cholecalciferol (vitamin D)|"1000 IU once daily x 1 month
~Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops."
16268012|NCT00879424|Dietary Supplement|Placebo|"1000 IU once daily x 1 month
~Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops."
16268013|NCT00879411|Drug|Micardis|
16268014|NCT00879398|Drug|Toviaz treatment|4 mg starting then can be followed by 8 mg
16268094|NCT00878800|Drug|PXD101|Administered in combination with doxorubicin (BelDox)
16268015|NCT00879385|Drug|Dacogen™ (decitabine)|"Dacogen™ (decitabine) is a FDA approved drug (NDA - 021790) for the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia).
~Decitabine will be given on this study at 45 mg/m2 IV over 2 hrs"
16268016|NCT00879385|Drug|Vectibix® (panitumumab)|"Vectibix® (panitumumab) is a FDA approved drug (BLA-125147) indicated as a single agent for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival.
~DRUG DESCRIPTION Vectibix® (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Panitumumab has an approximate molecular weight of 147 kDa. Panitumumab is produced in genetically engineered mammalian (Chinese Hamster Ovary) cells.
~Panitumumab will be given on this study at 6 mg/kg, IV over 1 hr"
16268017|NCT00879372|Drug|tianeptine|tianeptine 12,5mg TID
16268018|NCT00879372|Drug|Placebo|Placebo 12.5 mg TID
16268019|NCT00879359|Drug|carboplatin, paclitaxel, and bevacizumab|All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
16268020|NCT00879346|Drug|AZD8931|160mg oral single dose (4 x 40mg tablets)
16268021|NCT00879333|Drug|Everolimus|Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
16268022|NCT00879333|Drug|Everolimus placebo|Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
16268023|NCT00879333|Drug|Best Supportive Care (BSC)|Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
16268024|NCT00879307|Drug|quetiapine|Use of quetiapine for 16 weeks in acute mania and depression
16268025|NCT00879294|Device|Motion sickness wristband|No drugs are involved.
16268026|NCT00879294|Dietary Supplement|Chewing Gum|Patients will be asked to chew gum for 20 minutes, four times daily.
16268027|NCT00879281|Behavioral|Action plan|"Individualized written Action Plan to enhance self-management and early detection of an exacerbation."
16268028|NCT00879268|Device|Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System|Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation
16268029|NCT00879255|Behavioral|Cognitive Processing Therapy Group Videoteleconference|Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
16268030|NCT00879255|Behavioral|Cognitive Processing Therapy Group In-Person|Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
16268031|NCT00879242|Drug|Deferasirox|Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.
16268032|NCT00879229|Drug|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
16268033|NCT00879229|Drug|Placebo|Placebo to match ambrisentan administered orally once daily.
16268034|NCT00879216|Drug|VA106483|4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
16268035|NCT00879216|Drug|Placebo|4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
16268036|NCT00879190|Drug|Unasyn|Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
16268037|NCT00879190|Drug|Ampicillin/gentamicin|Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
16268038|NCT00879177|Drug|Varenicline|Varenicline: 1 tab 0.5mg once a day for 3 days; 1 tab 0.5mg twice a day for 4 days; followed by 1 tab 1mg twice a day for 11 weeks.
16268039|NCT00879177|Behavioral|behavioral therapy|confirmed negative smoking status at different time points
16268040|NCT00879164|Drug|bupivacaine hydrochloride|
16268041|NCT00879164|Other|questionnaire administration|
16268042|NCT00879151|Behavioral|Cognitive Behavioral Therapy for Adolescents|The therapist will work with the adolescent to understand triggers to binge eating and purging, such as thoughts, feelings, and interpersonal difficulties. Also, establishing regular eating patterns and eliminating medically harmful behaviors associated with the eating disorder is a primary goal.
16268043|NCT00879151|Behavioral|Supportive Psychotherapy|SPT focuses on having the patient build a relationship with the therapist and explore their unique individual needs within the context of their life and the experience of having an eating disorder.
16268044|NCT00879151|Behavioral|Family Based Therapy for Bulimia Nervosa|FBT helps parents to take an active role in guiding their child through eating disorder treatment. In this therapy, the parents are supported in helping their child stop bingeing, purging and engaging in other harmful weight-control behaviors. The way in which the eating disorder has impacted the family and the adolescent's development is also explored.
16268045|NCT00879138|Drug|VA106483|
16268046|NCT00879138|Drug|Sugar pill|
16268047|NCT00879112|Drug|MB07811|Oral
16268048|NCT00879112|Drug|Placebo|Oral
16268049|NCT00879099|Drug|Paroxetine|Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
16268050|NCT00879099|Drug|Placebo|Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
16268051|NCT00879099|Drug|timolol maleate|Oftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
16268052|NCT00879099|Drug|timolol maleate|Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
16268053|NCT00879086|Drug|eribulin mesylate|"E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 - 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
~The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment."
16268055|NCT00879073|Drug|Bendamustine|Approximately 15-24 study patients will be enrolled in this Phase I trial. Study patients will receive a weekly dose of IV bendamustine with whole brain radiation therapy for 3 weeks and then receive a fourth dose of IV bendamustine one week after completion of whole brain radiation therapy. The first dose of IV bendamustine will be given when whole brain radiation is initiated.
16268056|NCT00879060|Drug|Spironolactone|spironolactone 50mg daily
16268057|NCT00879060|Drug|Placebo|inactive placebo pill daily
16268058|NCT00879047|Drug|Alcohol|Consumed orally as liquid mixed with a juice beverage, 1 g/kg formula, administered once at baseline and again at either 2 or 3 weeks
16268059|NCT00879047|Drug|Alcohol placebo|Liquid alcohol spritzed on top of juice beverage immediately prior to administration in order to give smell of alcohol, administered once at baseline and again at either 2 or 3 weeks
16268060|NCT00879034|Drug|Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level.
16268061|NCT00879034|Drug|Zoledronic Acid|Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight.
16268062|NCT00879034|Drug|Pravastatin|Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
16268063|NCT00879021|Drug|Lyrica|study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx. 49 weeks and followed for another 49 weeks after stopping the medication.
16268064|NCT00879021|Drug|matching placebo|150 mg by mouth ,twice a day for 49 weeks
16268065|NCT00879008|Drug|Moxifloxacin (Avelox, BAY12-8039)|Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information
16268066|NCT00878995|Drug|Placebo Testosterone|Placebo (Saline) Testosterone given IM once per week.
16268067|NCT00878995|Drug|Testosterone Enanthate 100 MG/ML|Testosterone Enanthate 100mg/ml given once per week IM.
16268068|NCT00878969|Drug|valsartan (ARB)|
16268069|NCT00878969|Drug|ramipril (ACE inhibitor)|
16268070|NCT00878969|Drug|Placebo|
16268071|NCT00878956|Drug|Sodium Bicarbonate|In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium bicarbonate at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).
16268072|NCT00878956|Drug|Sodium Chloride|In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium chloride at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).
16268073|NCT00878943|Drug|Sildenafil citrate|20 mg tablet to be taken thrice daily for 1 year
16268074|NCT00878917|Drug|Dorzolamide 2 % eye drops solution|1 drop into eye(s) three times a day for the duration of each treatment phase
16268075|NCT00878904|Drug|epirubicin hydrochloride|
16268076|NCT00878904|Drug|panobinostat|
16268077|NCT00878904|Genetic|gene expression analysis|
16268078|NCT00878904|Genetic|protein expression analysis|
16268079|NCT00878904|Genetic|western blotting|
16268080|NCT00878904|Other|immunologic technique|
16268081|NCT00878904|Other|laboratory biomarker analysis|
16268082|NCT00878904|Other|pharmacological study|
16268083|NCT00878891|Device|Continuous glucose monitoring for immediate correction of abnormal glycemia|Prevention of hyper and hypo glycemia
16268084|NCT00878878|Drug|Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)|"Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
~Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison."
16268085|NCT00878878|Drug|Dextrose|"Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
~Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison."
16268086|NCT00878865|Drug|Alprazolam|1 mg tablet one oral dose
16268087|NCT00878865|Drug|Alprazolam|1 mg tablet
16268088|NCT00878852|Behavioral|Standard treatment|Participants will be randomly assigned to a standard treatment group. Patients allocated to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy
16268089|NCT00878852|Behavioral|Standard Treatment Plus Contingency Management Program|Participants assigned to this group will receive active treatment in form of 12-session intervention program. This program includes weekly intervention sessions developed according to the MET/CBT12 treatment protocol (Sampl, Kadden, 2001). Intervention includes Motivational interviewing (2 sessions) and Cognitive behavioral therapy (10 sessions). This treatment protocol will be supplemented with a contingency management intervention. Intervention will consist in a voucher program: negative urine-screens will be rewarded with vouchers. Voucher will have an increasing value. At the end of the program, vouchers can be changed by gifts. Potential gifts will be selected by the therapists and will be related to pro-social activities, aiming to change preexisting risk behaviours.
16268090|NCT00878839|Device|Toric|AcrySof Toric IOL
16268091|NCT00878826|Drug|Enoxaparin|"Drug: Enoxaparin 40 mg every morning until 36 weeks gestation. Drug: Enoxaparin 1 mg per kg every morning until 36 weeks gestation. Dose will increase at wt. increases.
~Drug: Enoxaparin dose taken by patient when enrolled until 36 weeks gestation."
16268092|NCT00878813|Procedure|Sampling of 15ml blood|On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling
16268093|NCT00878813|Procedure|Blood-Sampling|On day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn.
16268099|NCT00878761|Biological|STX-100|SC, single dose followed by multiple dose
16268100|NCT00878748|Drug|Effexor XR|
16268101|NCT00878748|Other|Effexor XR discontinue|
16268102|NCT00878735|Behavioral|Zen meditation|Zen meditation retreat (7 days: 5 days from 5:30 to 9:30 plus one day for adaptation and the departure day). The program starts everyday at 5:30 and finish at 9:30. In silence, the volunteers perform seating and walking meditation, stretching exercises, eating and all tasks in mindfulness.
16268103|NCT00878722|Drug|PXD101|
16268104|NCT00878722|Drug|idarubicin|
16268105|NCT00878709|Drug|neratinib|
16268106|NCT00878709|Other|placebo|
16268107|NCT00878696|Procedure|TMS transcranial magnetic stimulation|"200 pulses of tonic TMS (see Graph 1) were administered with an intensity at 50% of the maximal TMS device output (50%DO).
~The frequency of the tonic pulses was randomly chosen between 1Hz, 5Hz, 10Hz or 20Hz.
~Burst stimulation was delivered at a burst frequency of 5, 10 or 20Hz. Each burst consisted of 3, 5 or 10 pulses. The individual pulse rate within a burst was 50 or 100Hz."
16268108|NCT00878683|Device|silicone catheter boot|silicone device using Dermabond
16268109|NCT00878670|Drug|EPOGAM 1000|One capsule of EPOGAM 1000 contains 932-1073 mg Oenothera seminis oleum, equivalent to 80 mg gamma-linolic acid. Children (2-12 years) take 2 capsules in the morning and evening, whereas persons over 12 years take 3 capsules in the morning and evening. The duration of the treatment is 12 weeks.
16268110|NCT00878657|Drug|gemcitabine hydrochloride|Pre-Chemoradiation (Induction) Chemotherapy Gemcitabine will be given weekly for seven doses at a dose of 1000 mg/m2/wk (Days 1, 8, 15, 22, 29, 36, 43) unless toxicity develops. Chemoradiation gemcitabine will be given 400 mg/m2, infused over 30 minutes, within 120 minutes before radiotherapy. Post-chemoradiation chemotherapy, patients will receive two cycles of gemcitabine. A cycle will be defined as three weeks of gemcitabine at 1000 mg/m2/d, once weekly, followed by a one-week rest.
16268111|NCT00878657|Radiation|intensity-modulated radiation therapy|"Dose escalation levels (cohorts) for this study:
~Dose Level 1: GTV plus drainage areas 45 Gy, Boost GTV 50.4 Gy Dose Level 2: GTV plus drainage areas 45 Gy, Boost GTV 54.0 Gy Dose Level 3: GTV plus drainage areas 45 Gy, Boost GTV 59.4 Gy Dose Level 4: GTV plus drainage areas 45 Gy, Boost GTV 64.8 Gy Dose Level 5: GTV plus drainage areas 45 Gy, Boost GTV 70.2 Gy"
16268112|NCT00878644|Procedure|Therapeutic Hypothermia|Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.
16268113|NCT00878644|Other|Therapeutic Normothermia|Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
16268114|NCT00878631|Drug|hypertonic saline mixed with dextran|a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 is given within 4 hours from the time of the accident
16268115|NCT00878631|Drug|Normal Saline|250 ccs of normal saline infused within 4 hours of the accident
16268116|NCT00878618|Drug|AZD0837|Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days
16268117|NCT00878618|Drug|AZD0837|Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days
16268118|NCT00878605|Drug|Cyclo-Z|Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
16268119|NCT00878605|Drug|Placebo|Placebo control
16268120|NCT00878592|Behavioral|Dietary and life style modification|This group will receive a weight management and life style modification program. It consists of up to 6 weekly sessions of nutritional and physical exercise education. These initial sessions will concentrate on lifestyle modifications program including healthy food selections, emphasizing reduced fat consumption (<=30% of daily calories) and restriction of proteins to create a daily negative energy balance of ~500 kcal/day. Participants will be encouraged to start with 10 minutes of outdoor or at home physical activity such as walking or cycling then gradually increase the activity duration up to 30 minutes daily.
16268121|NCT00878579|Device|PDS System|Percutaneous Dynamic Stabilization System
16268122|NCT00878579|Device|Fusion|Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws
16268123|NCT00878566|Other|Enhanced pharmacist care|The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The pharmacist will also review the patient's current hypertensive therapy regimen and decide on the options for improvement of BP control (lifestyle modification, increase dose, additional BP medications), and implementation of these strategies.
16268124|NCT00878566|Other|Usual Care|Patients randomized to usual care will receive a wallet card for BP readings, pamphlet on BP and usual pharmacist and physician care. Patients will be seen at 12 weeks for interim BP measurement only. Both groups of patients will be seen at 24 weeks for BP measurement.
16268125|NCT00878553|Drug|placebo|tablet at bedtime
16268126|NCT00878553|Drug|SKP-1041 (experimental formulation of zaleplon)|tablet at bedtime
16268127|NCT00878540|Drug|mirtazapine|30 mg mirtazapine once daily for 7 days
16268128|NCT00878527|Device|CircuLite Synergy Pocket Circulatory Assist Device|Goal of successful implantation and follow-up for at least three months
16268129|NCT00878514|Drug|Alprazolam|Alprazolam 1 mg tablet
16268130|NCT00878514|Drug|Xanax|Xanax 1 mg tablet
16268131|NCT00878501|Drug|AZD1386|oral, during 4 weeks
16268132|NCT00878501|Drug|AZD1386|oral, during 4 weeks
16268133|NCT00878501|Drug|Placebo|Oral, during 4 weeks
16268134|NCT00878462|Drug|Asenapine WHITE raspberry flavor (Treatment A)|Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
16268135|NCT00878462|Drug|Asenapine RED raspberry flavor (Treatment B)|Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
16268136|NCT00878462|Drug|Asenapine WHITE UNFLAVORED (Treatment C)|Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
16268137|NCT00878449|Drug|ABT-263|150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
16268216|NCT00877929|Drug|Telmisartan 80|Telmisartan 80 mg
16268138|NCT00878449|Drug|etoposide/cisplatin|etoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles
16268139|NCT00878436|Drug|Panobinostat|
16268140|NCT00878436|Drug|Bicalutamide|
16268141|NCT00878423|Drug|AT13387|Two dosing schedules will be evaluated; twice or once weekly dosing, on three weeks out of four. The starting dose for the once weekly schedule was 10mg/m2/dose, given as one hour intravenous (IV) infusions on Days 1, 4, 8, 11, 15 and 18 of a twenty-eight day cycle. The starting dose for the twice weekly schedule, given as one hour intravenous (IV) infusions on Days 1, 8 and 15 of a twenty-eight day cycle, will be 150mg/m2/dose
16268142|NCT00878423|Drug|AT13387|Intravenous infusion over one hour on days 1, 4, 8, 11, 15 and 18, every four weeks or intravenous infusion over one hour on days 1, 8 and 15, every four weeks . Treatment may be continued indefinitively in the presence of clinical benefit
16268143|NCT00878397|Device|School-based delivery of long lasting insecticide nets|Free distribution of long lasting insecticide nets to school children and their younger siblings
16268144|NCT00878384|Drug|Medication to control ventricular rate in AF|Standard pharmacologic rate control. Current therapy will be adjusted to achieve rate-control targets of <80bpm and <110bpm on exercise (6 minute walk). Where necessary, additional medication will be given as per standard practice (digoxin or beta-blocker). Typical does: Digoxin 62.5-250mcg o.d. ; Bisoprolol 1.25-20mg o.d.; Carvedilol 3.125-50mg b.d. ; Nebivolol 1.25-10mg o.d.
16268145|NCT00878384|Procedure|Catheter Ablation for Persistent Atrial Fibrillation|Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.
16268146|NCT00878371|Drug|morphine|All patients treated with Morphine during induction after the lumbar drain inserted. Morphine was prescribed as Standard of care post operatively
16268147|NCT00878358|Other|Hydrotherapy|
16268148|NCT00878358|Other|Physiotherapy|
16268149|NCT00878345|Drug|dexmedetomidine sedation protocol|Arm 1 will undergo sedation with dexmedetomidine, using 2 mcg/kg load IV over 10 minutes followed by an IV infusion of 1 mcg/kg/hr. May use versed 0.5 mg/kg IV x 1 for incomplete sedation, followed by increase of dexmedetomidine infusion to 1.5 mcg/kg/hr. Infusion will run throughout non-painful procedure (most likely MRI).
16268150|NCT00878345|Drug|pentobarbital sedation protocol|"Pentobarbital Sedation Protocol IV: 2.5 mg/kg, followed by 1.25 mg/kg as needed x2. Maintenance: May give additional 1.25 mg/kg IV x 2 if needed. Max total dose of 200 mg pentobarbital throughout sedation.
~May give midazolam 0.05 mg/kg IV x 1 PRN agitation for rescue sedation."
16268151|NCT00878319|Procedure|Open reduction and internal fixation (ORIF)|Antero-latero or posterior surgical approach using dynamic compression plate
16268152|NCT00878319|Other|Non-surgical|Sugartong splint followed by transition to functional co-aptation brace
16268153|NCT00878306|Drug|Disulfiram|62.5 mg daily x3 days, then 250 mg daily x3 days
16268154|NCT00878306|Drug|Disulfiram + Efavirenz|Efavirenz 600 mg daily x10 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days
16268155|NCT00878306|Drug|Disulfiram + Atazanavir|Atazanavir 400 mg daily x8 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days
16268156|NCT00878306|Drug|Disulfiram + Ritonavir|Ritonavir 200 mg daily x8 days, then in addition with 62.5 mg daily x3 days, then Disulfiram 250 mg daily x3 days
16268157|NCT00878293|Drug|GRT6005|liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
16268158|NCT00878293|Drug|MS Continus®|60 mg, capsule, once daily
16268159|NCT00878293|Drug|Placebo|liquid formulation and capsule, once daily
16268160|NCT00878267|Behavioral|Interview|3 step process including person to person meeting and questionnaires taking about 30 minutes.
16268161|NCT00878254|Biological|G-CSF|Granulocyte-colony stimulating factor (G-CSF) 480 mcg subcutaneously (SQ) starting on Day 13 of Cycles 1 and 3; and Day 7 of Cycles 2 and 4, per study protocol.
16268162|NCT00878254|Drug|Rituximab|Rituximab 375 mg/m^2 intravenously (IV) on Day 1 for 4 Cycles, per study protocol. For study participants achieving complete remission, during maintenance therapy every 6 months for up to three years, per study protocol.
16268163|NCT00878254|Drug|Cyclophosphamide|Cyclophosphamide 800 mg/m^2 IV on Day 1 and 200 mg/m^2 IV on Days 2 through 5 of Cycles 1 and 3, per study protocol.
16268164|NCT00878254|Drug|Cytarabine|Cytarabine 2 grams/m^2 IV on Days 1 and 2 of Cycles 2 and 4, per study protocol.
16268165|NCT00878254|Drug|Doxorubicin|Doxorubicin 45 mg/m^2 IV bolus Day 1 of Cycles 1 and 3, per study protocol.
16268166|NCT00878254|Drug|Etoposide|Etoposide 60 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
16268167|NCT00878254|Drug|Ifosfamide|Ifosfamide 1.5 grams/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
16268168|NCT00878254|Drug|Leucovorin|Leucovorin: 100 mg/m^2 IV beginning 36 (+/-4) hours after start of Methotrexate infusion, and then 10 mg/m^2 at 6 hour (+/- 30 min) intervals until Methotrexate level is < 0.1 µmol/L during Cycles 1 and 3 per study protocol.
16268169|NCT00878254|Drug|Mesna|Mesna 360 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4, per study protocol.
16268170|NCT00878254|Drug|Methotrexate|Methotrexate 1,200 mg/m^2 in 250 mL D5W IV over 1 hour, followed by Methotrexate 3,000 mg/m^2 in 1,000 mL D5W by continuous infusion over 23 (+/-2) hours on Day 10 of Cycles 1 and 3, per study protocol.
16268171|NCT00878254|Drug|Vincristine|Vincristine 1.5 mg/m^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3, per study protocol.
16268172|NCT00878241|Device|Compression Anastomosis Ring: CAR™ 27|Creation of anastomosis in colorectal surgeries using CAR™ 27
16268173|NCT00878228|Drug|Ondansetron|The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.
16268174|NCT00878228|Drug|Placebo|The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.
16268175|NCT00878215|Device|Explorer Liver Image Guided System|
16268176|NCT00878215|Device|Explorer Liver Passive Tracking|
16268177|NCT00878215|Procedure|Liver surgery|-Standard of care
16268178|NCT00878215|Procedure|Liver abalation|-Standard of care
16268179|NCT00878202|Device|SCAD information system|Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months
16268180|NCT00878189|Drug|PF-03084014|10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily
16268181|NCT00878176|Procedure|First stage tined lead procedure|bilateral first stage tined lead placement
16268182|NCT00878163|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16268183|NCT00878163|Drug|Erlotinib Hydrochloride|Given PO
16268184|NCT00878163|Drug|Gemcitabine Hydrochloride|Given IV
16268185|NCT00878163|Drug|Vismodegib|Given PO
16268186|NCT00878150|Behavioral|In-person Cognitive Behavioral Therapy|12 sessions of CBT delivered in-person over 16 weeks
16268187|NCT00878150|Behavioral|Telephone Cognitive Behavioral Therapy|12 sessions of telephone-based CBT over 16 weeks
16268188|NCT00878137|Device|INR by point-of-care instruments and venopuncture|Three fingersticks will be performed and from each one drop of capillary or venous whole blood collected from a fingerstick performed by the primary investigator to measure PT/INR using the CoaguChekXSTM (10 microliters), ProTimeTM (27 microliters), the investigational ProTime, and INRatioTM 15 microliters) point-of-care instruments and one i.v. blood draw (20 mL of blood) will be performed by a phlebotomist.
16268189|NCT00878124|Dietary Supplement|Coenzyme Q10 co treatment|CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study.
16268190|NCT00878124|Other|Placebo Caps|3 caps twice a day continuously until pregnant or at the end of the study.
16268191|NCT00878111|Drug|NGR-hTNF|"First cohort: iv q3W 60 mcg/sqm over 120 min*
~Second cohort: iv q3W 80 mcg/sqm over 120 min*
~Third cohort: iv q3W 100 mcg/sqm over 120 min*
~Fourth cohort: iv q3W 125 mcg/sqm over 120 min*
~Fifth cohort: iv q3W 150 mcg/sqm over 120 min*
~Sixth cohort: iv q3W 175 mcg/sqm over 120 min*
~Seventh cohort: iv q3W 200 mcg/sqm over 120 min*
~Eighth cohort: iv q3W 225 mcg/sqm over 120 min*
~Ninth cohort: iv q3w 250 mcg/sqm over 120 min*
~Tenth cohort: iv q3w 275 mcg/sqm over 120 min*
~Eleventh cohort: iv q3w 300 mcg/sqm over 120 min*
~Twelfth cohort: iv q3w 325 mcg/sqm over 120 min*
~* If the first infusion is well-tolerated, the second infusion may be delivered over 90 minutes. If the 90-minute infusion is well tolerated, all subsequent infusions may be delivered over a 60-minute period."
16268192|NCT00878085|Device|Robot Therapy Device|3x a week for 4 weeks
16268193|NCT00878085|Behavioral|Occupational Therapy|3x a week for 4 weeks
16268194|NCT00878072|Drug|Famciclovir|Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
16268195|NCT00878046|Device|DePuy Silent™ Hip femoral prosthesis|A short cementless, femoral component for use in total hip arthroplasty
16268196|NCT00878020|Drug|BMS-830216|Capsules, Oral, Single Dose, 1 day
16268197|NCT00878020|Drug|Placebo|Capsules, Oral, 0mg, Single Dose, 1 day
16268198|NCT00878020|Drug|BMS-830216|Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days
16268199|NCT00878020|Drug|Placebo|Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days
16268200|NCT00878007|Drug|Intermittent screening and treatment for malaria|All children will be screened for malaria using rapid diagnostic tests (RDTs) once a term (thrice yearly). Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with artemether-lumefantrine according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team.
16268201|NCT00878007|Behavioral|Teacher training on literacy instruction|Education intervention designed to improved early grade literacy instruction, focusing on phonological awareness & vocabulary and relationship between letters and sounds in a systematic and explicit fashion. Specific interventions will include training on (i) how to monitor students' progress in large classes (ii) developing and using instructional materials for reading (iii) lesson planning for explicit teaching of letter-sound relationships (iv) instructional techniques for large classes.
16268202|NCT00878007|Other|IST plus literacy instruction programme|Schools will receive both IST and the literacy instruction programme
16268203|NCT00877994|Behavioral|Nurture Support Group Therapy|Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists.
16268204|NCT00877994|Behavioral|Group therapy|Participants will be randomly assigned (like the flip of a coin) to either receive the curriculum immediately (immediate group) or at a later time point approximately 16 weeks later (delayed group). Both groups will receive 16, 90 minute long group sessions delivered over 4 months. Groups will include 4-8 mothers and one or two co-therapists. The curriculum will focus on increasing positive healthy eating patterns in children of mothers who have had disordered eating and body image struggles.
16268205|NCT00877981|Procedure|Minimal invasive Parathyroid surgery|
16268206|NCT00877968|Dietary Supplement|Whole wheat banana bread|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 62.8 g Available CHO: 51.7 g"
16268207|NCT00877968|Dietary Supplement|Whole pea flour banana bread|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 67.8 g Available CHO: 52.0 g"
16268208|NCT00877968|Dietary Supplement|Whole wheat biscotti|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 79.8 g Available CHO: 53.1 g"
16268209|NCT00877968|Dietary Supplement|Whole pea flour biscotti|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 86 g Available CHO: 51.7 g"
16268210|NCT00877968|Dietary Supplement|Whole wheat pasta|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion (Dry): 70 g Available CHO: 51.1 g"
16268211|NCT00877968|Dietary Supplement|Whole pea pasta|"Dose was portioned so that subjects received 50 g available carbohydrate Pea pasta is 30% whole pea pasta, 70 white wheat durum
~Portion (Dry pasta) : 90 g Available CHO: 53.1 g"
16268212|NCT00877968|Dietary Supplement|White bread|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 100 g Available CHO: 50 g"
16268213|NCT00877968|Dietary Supplement|Boiled yellow peas|"Dose was portioned so that subjects received 50 g available carbohydrate
~Portion: 100 g (dry) --> 250 g cooked Available CHO: 52.8 g"
16268214|NCT00877955|Drug|alprazolam sublingual tablet commercial|0.5 mg sublingual tablet, single dose
16268215|NCT00877955|Drug|alprazolam sublingual tablet test|0.5 mg tablet, single dose
16268217|NCT00877929|Drug|Amlodipine 10|Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
16268218|NCT00877929|Drug|Amlodipine 10|Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
16268219|NCT00877903|Drug|Prochymal®|Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
16268220|NCT00877903|Drug|Placebo|Intravenous infusion of excipients of Prochymal®
16268221|NCT00877890|Drug|exenatide once weekly|subcutaneous injection, 2.0mg, once a week
16268222|NCT00877890|Drug|exenatide twice daily|subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day
16268223|NCT00877877|Procedure|Blood sampling|Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
16268224|NCT00877864|Behavioral|High volume combined aerobic/resistance exercise|High volume combined aerobic/resistance exercise
16268225|NCT00877864|Behavioral|Low volume combined aerobic/resistance exercise|Low volume combined aerobic/resistance exercise
16268226|NCT00877864|Behavioral|High volume combined A/R exercise, printouts, pedometers|High volume combined aerobic/resistance exercise, printouts, pedometers
16268227|NCT00877864|Behavioral|Low volume combined A/R exercise, printouts, pedometers|Low volume combined aerobic/resistance exercise, printouts, pedometers
16268228|NCT00877864|Behavioral|Printed PA information, pedometers and step log group|Printed PA information, pedometers and step log group
16268229|NCT00877864|Behavioral|Control|No exercise program provided by the study
16268230|NCT00877851|Behavioral|CD-ROM|The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the CD-ROM and some instructions on how to navigate around the different sections of the CD-ROM. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the CD-ROM on at least a weekly basis.
16268231|NCT00877838|Drug|NXN-188|NXN-188 600 mg (3 gelatin capsules each containing 200 mg) when experiencing migraine aura.
16268232|NCT00877838|Drug|Placebo|Gelatin capsules resembling the ones containing the active substance
16268233|NCT00877825|Procedure|dairy food control diet and high- and low- isoflavone soyfood diets|
16268234|NCT00877812|Dietary Supplement|Arm 1 glycine and leucine|Arm 1 glycine and leucine: A subset of 14 participants out of the total enrolled participants with an adequate nutritional status will undergo the tracer infusion of glycine and leucine amino acids protocol while an adequate vitamin pyridoxine, B6 status. After the first infusion each participant will then begin a diet low in vitamin B6 (<0.5 mg/d) for 4 weeks to achieve marginal B6 status followed by a repeat of fasting blood sampling and tracer infusion protocol.
16268235|NCT00877812|Dietary Supplement|Arm 2 Intervention of Serine and methionine infusion|Arm 2 Intervention of Serine and methionine infusion: A subset of 14 participants out of the total enrolled participants. Received an adequate nutritional status will undergo the tracer infusion of methionine and serine amino acids protocol while in adequate vitamin pyridoxine, B6 status. After the first infusion each subject will then begin a diet low in vitamin B6 (<0.5 mg/d) for 4 weeks to achieve marginal B6 status followed by repeat of fasting blood sampling and tracer infusion protocol.
16268236|NCT00877799|Drug|CR845|CR845 (0.024 mg/kg) administered the day after surgery (Day 1)
16268237|NCT00877799|Drug|CR845|CR845 (0.008 mg/kg) administered the day after surgery (Day 1)
16268238|NCT00877799|Drug|CR845|CR845 (0.040 mg/kg) administered immediately after surgery (Day 0)
16268239|NCT00877799|Drug|Placebo|Matched placebo administered the day after surgery (Day 1)
16268240|NCT00877799|Drug|Placebo|Matched placebo administered immediately after surgery (Day 0)
16268241|NCT00877786|Behavioral|Cognitive Behavioral Group Therapy|Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
16268242|NCT00877773|Drug|Temsirolimus|25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
16268243|NCT00877760|Drug|pegylated interferon a-2a|180 μg, once per week s.c. for 24 weeks
16268244|NCT00877760|Drug|Entecavir|0.5 mg once daily per os, either 72 weeks or 96 weeks
16268245|NCT00877734|Drug|baclofen|10 mg Baclofen administered tid for 11 weeks
16268246|NCT00877734|Drug|placebo|Placebo administered tid for 11 weeks
16268247|NCT00877734|Behavioral|BRENDA counseling|
16268248|NCT00877721|Device|Self Mobility Improvement in the eLderly by using the SMILING system|The effect of treatment with the SMILING system on postural stability and gait of elderly individuals will be measured using RCT cross over study design
16268249|NCT00877695|Behavioral|Entre Culturas: Navigating Culture, Identity, and HIV Risk|A pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing.
16268250|NCT00877682|Procedure|Cryoablation|Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
16268251|NCT00877669|Procedure|Transurethral resection of the prostate|Standard transurethral resection of the prostate using electrocautery loop
16268252|NCT00877669|Procedure|Holmium Laser Enucleation of the Prostate|HoLEP using 100W Ho:YAG laser
16268253|NCT00877656|Biological|HuMax-CD4|Active treatment
16268254|NCT00877643|Other|Upstream therapy|Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
16268255|NCT00877643|Other|Conventional rhythm control|Usual care for atrial fibrillation and heart failure according to the present guidelines
16268256|NCT00877617|Behavioral|QOL Questionnaire|Mailed survey.
16268257|NCT00877604|Drug|tauroursodeoxycholic acid (TUDCA)|Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year
16268258|NCT00877604|Drug|Placebo|identical placebo by oral route at the same dosing schedule
16268259|NCT00877591|Drug|Fosamprenavir/Ritonavir|1400/200 mg once daily for 15 days total
16268260|NCT00877591|Drug|Darunavir/Ritonavir|800/100 mg once daily for 15 days total
16268261|NCT00877591|Drug|Rifampin|600 mg once daily for 15 days total
16268262|NCT00877591|Drug|Rifabutin|300 mg once daily for 15 days total
16268263|NCT00877591|Drug|Buprenorphine|"FOSAMPRENAVIR/RITONAVIR Dosing information: 1400 mg fosamprenavir + 200 mg ritonavir once daily for 15 days
~DARUNAVIR/RITONAVIR Dosing information: 800 mg darunavir + 100 mg ritonavir once daily for 15 days
~RIFAMPIN Dosing information: 600 mg once daily in the morning for 15 days
~RIFABUTIN Dosing information: 300 mg once daily in the morning for 15 days"
16268264|NCT00877578|Dietary Supplement|Nutri-Energie ®, Aliscience society|Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
16268265|NCT00877578|Dietary Supplement|Clinutren 1.5 ®, Nestlé Clinical Nutrition|Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet
16268266|NCT00877539|Drug|PF-03526299|Inhaled, two doses 4 hours apart
16268267|NCT00877539|Drug|Placebo|Inhaled, two doses 4 hours apart
16268268|NCT00877539|Drug|Fluticasone propionate|Inhaled
16268269|NCT00877526|Other|No treatment given|Subject will only fill out a questionaire when entering the observational study.
16268270|NCT00877513|Behavioral|Smoking cessation|Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion
16268271|NCT00877500|Other|Best Practice|Receive standard of care
16268272|NCT00877500|Drug|Ixabepilone|Given IV
16268273|NCT00877487|Drug|SPD489 (Lisdexamfetamine dimesylate)|1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
16268274|NCT00877487|Drug|Placebo|1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.
16268275|NCT00877474|Drug|PM01183|Vials containing 0.2 mg of PM01183 as powder for concentrate for solution for infusion
16268276|NCT00877448|Biological|Adjuvanted Multimeric-001 250 Mcg|
16268277|NCT00877448|Biological|Multimeric-001 250 Mcg|
16268278|NCT00877448|Biological|Phosphate Buffered saline|
16268279|NCT00877448|Biological|Adjuvanted PBS|
16268280|NCT00877448|Biological|Adjuvanted Multimeric-001 500 Mcg|
16268281|NCT00877448|Biological|Multimeric-001 500 Mcg|
16268282|NCT00877448|Biological|Multimeric-001 125 Mcg|
16268283|NCT00877435|Behavioral|Cognitive behavioral therapy (CBT)|
16268284|NCT00877422|Dietary Supplement|Vitamin D3|Group A and Group C are followed without drugs and Group B is followed with vitamin D3.
16268285|NCT00877409|Drug|Benzoyl Peroxide 5% and Sulphur 2%|The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
16268286|NCT00877409|Drug|Vehicle of Acnase|The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
16268287|NCT00877396|Biological|Influenza vaccination|Influenza vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose (0.5 mL) 4 weeks later.
16268288|NCT00877396|Biological|Hepatitis A Vaccine|Hepatitis vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose ( saline- 0.5 mL) 4 weeks later.
16268289|NCT00877383|Drug|Indacaterol 150 μg|Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16268290|NCT00877383|Drug|Tiotropium 18 μg|Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).
16268291|NCT00877383|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16268292|NCT00877370|Drug|ertapenem|One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
16268293|NCT00877357|Biological|Shan 5|Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
16268294|NCT00877344|Procedure|Immediate insertion|Immediate timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
16268295|NCT00877344|Procedure|Interval insertion|Interval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
16268296|NCT00877331|Behavioral|Brief intervention using motivational interviewing|One brief, in-person motivational interviewing session (30-45 minutes) in conjunction with the medical appointment. Plus one brief follow-up phone call one week later.
16268297|NCT00877318|Device|SCAD information system|Cardiac rehabilitation at home by telemedicine
16268298|NCT00877305|Procedure|Remote Ischemic Preconditioning|RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 200 mmHg (at least a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line).
16268299|NCT00877305|Other|Control|Sham intervention with four 5-min cycles of inflation of the blood pressure cuff at 20 mmHg and 5 min deflation without any upper leg ischaemia.
16268300|NCT00877279|Device|CosmoDerm1|CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
16268301|NCT00877279|Device|Belotero Soft|Dermal Filler
16268340|NCT00876993|Drug|Irinotecan|Irinotecan 125 mg/m2 on day 1 and day 15 of a 28 day course given IV for the first 3 dose levels. If the Maximum Tolerated Dose of temozolomide is not reached at dose level 3, then dose level 4 will be an escalation of irinotecan to 150mg/m2.
16268543|NCT00875420|Drug|RAD1901|100 mg Oral once a day for 28 days
16268302|NCT00877266|Procedure|perineural mepivicaine catheter placed via ultrasound or electrical stimulation|Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels.
16268303|NCT00877253|Drug|Genexol-PM 220mg/㎡, Carboplatin 5AUC|Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
16268304|NCT00877253|Drug|Genexol-PM 260mg/㎡, Carboplatin 5AUC|Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
16268305|NCT00877253|Drug|Genexol-PM 300mg/㎡, Carboplatin 5AUC|Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
16268306|NCT00877240|Behavioral|Behavioral intervention-to determine the effectiveness of a general intervention on healthy living habits of IDF staff|the program consists of 3 times a week of physical activity, nutrition advice, weight lodd program, stress workshop and smoking cessation workshop
16268307|NCT00877227|Drug|5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)|Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns.
16268308|NCT00877214|Drug|Rituximab|Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years
16268309|NCT00877214|Drug|Rituximab / observation|Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)
16268310|NCT00877201|Drug|CDR2|
16268311|NCT00877188|Other|exercise|supervised combined aerobic and progressive resistance training for 12 weeks
16268312|NCT00877175|Drug|1% tropicamide and 2.5% phenylephrine|For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.
16268313|NCT00877162|Behavioral|Controlled crying and routines|Behavioural (teaching and support)
16268314|NCT00877149|Drug|telbivudine/LDT600|
16268315|NCT00877136|Device|TheraSphere®|TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
16268316|NCT00877123|Drug|Oral vitamin D 100,000 IU|Oral vitamin D 100,000 IU once a month for three consecutive months.
16268317|NCT00877123|Drug|Placebo|similar placebo once a month for three consecutive months
16268318|NCT00877110|Drug|cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8|Patients will receive combination chemotherapy with intravenous (IV) cyclophosphamide 70mg/kg/day (for patients with body weight<70kg) or 2100mg/m2/day (for patients with body weight ≥70kg) for two days, IV vincristine 0.067mg/kg or 2mg/m2/day (lower of the two doses to be chosen; maximum 2mg) for one day, and IV topotecan 2.4 mg/m2/day for 3 days during their first cycle. If receiving a second and/or third cycle, the only chemotherapy patients will receive is cyclophosphamide at 50 mg/kg/day for 2 days. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor. On day +3, the patient will start daily infusion of 3F8 for 5 days. The treatment schedule may require minor adjustment by ±1 day as clinically indicated (e.g. due to PDH closure for holidays or due to inclement weather).
16268319|NCT00877097|Drug|Klodronate and Kliogest|
16268320|NCT00877097|Procedure|Placebo+ Kliogest|
16268321|NCT00877097|Drug|Bonefos|
16268322|NCT00877084|Other|Resistance training|Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion. The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
16268323|NCT00877084|Other|Usual care|usual care according to clinical pathway for COPD, No training
16268324|NCT00877071|Drug|LC Bead loaded with doxorubicin|LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
16268325|NCT00877058|Behavioral|preventive home visit|
16268326|NCT00877058|Behavioral|senior meetings|
16268327|NCT00877032|Biological|RN6G|intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.
16268328|NCT00877032|Biological|Placebo|intravenous, single dose with experimental dose.
16268329|NCT00877019|Device|Sonicare elite medium brush head|
16268330|NCT00877019|Device|Sonicare elite mini brushhead|
16268331|NCT00877019|Device|GABA Elmex sensitive extra soft toothbrush|
16268332|NCT00877019|Device|ADA reference toothbrush|
16268333|NCT00877006|Drug|bendamustine|
16268334|NCT00877006|Drug|rituximab|
16268335|NCT00877006|Drug|vincristine|
16268336|NCT00877006|Drug|prednisone|
16268337|NCT00877006|Drug|cyclophosphamide|
16268338|NCT00877006|Drug|doxorubicin|
16268339|NCT00876993|Drug|Bevacizumab|Bevacizumab 10 mg/kg IV on day 1 and day 15 of a 28 day cycle
16268341|NCT00876993|Drug|Temozolomide|For the first cohort (dose level 0) of patients, dosing is 75 mg/m2/day day 1-5 of a 28 day course given PO for the first course. Doses will be escalated according to standard phase I dose escalation criteria. Dose levels are as follows (Dose level 1 = 125mg/m2, Dose level 2 = 175mg/m2, Dose levels 3 and 4 = 200 mg/m2)
16268342|NCT00876980|Device|nasal Continuous Positive Airway Pressure|A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.
16268343|NCT00876967|Device|metallic single use blade|metallic single use blade
16268344|NCT00876967|Device|plastic single use blade|plastic single use blade
16268345|NCT00876967|Device|metallic reusable blade|metallic reusable blade
16268346|NCT00876954|Procedure|Normothermia|Warming without increase in core temperature
16268347|NCT00876954|Procedure|Hyperthermia|Core hyperthermia (39 °C) for 2,5 hours
16268348|NCT00876941|Behavioral|Standard Brief Intervention|"Intervention: Structured, brief negotiated interview.
~Intervention preparation and content: Preparation: review of ASSIST results; Content: The intervention involves 4 major parts: 1) establishing rapport and asking the subject for permission to raise the topic of drug use; 2) exploring the pros and cons of use; 3) providing feedback and assessing readiness to change; and 4) advising and negotiating a plan.
~Counselor: Health Promotion Advocate, High School graduate or GED minimum Training specific to the brief intervention: Didactic and experiential; competency demonstrated by observation and/or video recordings which are content scored using a standardized form.
~Contacts, Duration: One, 10-15 minutes.
~Communication content delivered to primary care physician: Results of screening and BI.
~Supervision: Weekly 1-hour meeting with supervisor to discuss job performance and discuss cases; biannual shadowing by supervisor."
16268349|NCT00876941|Behavioral|Enhanced Brief Intervention|"Intervention: Less structured, motivational interview.
~Intervention preparation and content: Preparation: review of ASSIST, drug consequences (SIP-D), risk behaviors, CIDI Short Form, and medical record for discussion; Content: Motivational interviewing discussing above.
~Counselor: Master's level/Doctoral student.
~Training specific to the brief intervention: Didactic and experiential, followed by additional work towards, and confirmation of, proficiency using audio recordings coded for motivational interviewing content.
~Contacts, Duration: One plus offer of one optional booster contact, each 30-45 minutes; 2nd by telephone or in person depending on subject's preference; availability of counselor for further readiness discussions.
~Communication content delivered to primary care physician: Results of screening, BI, and plan including follow-up.
~Supervision: Weekly 1.5-hour meeting with supervisor with review of coded audio recordings."
16268350|NCT00876941|Behavioral|Control: Information and Feedback|Subjects randomized to the control group will not receive a BI at enrollment. But, all study subjects will receive screening and its results as part of the informed consent process (that they are at least at risk for drug use health hazards) along with a written list of resources available, including local options.
16268351|NCT00876928|Drug|vitamin D|liquid vitamin D3 dissolved in medium chain triglyceride once a week
16268352|NCT00876928|Drug|placebo|medium chain triglyceride given once per week
16268353|NCT00876915|Drug|dalteparin injection|Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
16268354|NCT00876902|Drug|recombinant P-selectin glycoprotein ligand Ig fusion protein|The active study drug dose includes both a 1 mg/kg IV infusion for the recipient and a 20 mg [approximately 0.27 mg/kg] as an ex vivo flush. The doses will be administered via 2 separate infusions of study agent: one 20 mg dose into the portal vein of the liver prior to implantation as an ex vivo flush with Viaspan®; and the second infusion of 1 mg/kg intravenously into the recipient, when technically feasible, prior to the hepatic artery anastomosis. Those patients that experience an intraoperative blood loss of >10 units, will receive an additional 1 mg/kg IV infusion of study agent at the end of the transplant surgery.
16268355|NCT00876902|Drug|Viaspan® and saline|Placebo of a volume equivalent to active study drug will be prepared for administration to the control group to help maintain the blind. Those patients that experience an intraoperative blood loss of >10 units, will receive an additional 1 mg/kg IV infusion of placebo equivalent at the end of the transplant surgery.
16268356|NCT00876889|Drug|Riluzole|50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses).
16268357|NCT00876876|Drug|Lixivaptan|Capsules containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period.
16268358|NCT00876863|Drug|CERE-110: Adeno-Associated Virus injection Surgery|Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.
16268359|NCT00876863|Procedure|Placebo Surgery|Placebo Surgery
16268360|NCT00876850|Drug|PTK 0796|PTK 0796 100mg for injection; PTK 0796 tablet 150mg
16268361|NCT00876850|Drug|Linezolid|For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution
16268362|NCT00876824|Drug|Amphotericin B Lipid emulsion|Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis
16268363|NCT00876824|Drug|Liposomal Amphotericin B|Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B
16268364|NCT00876811|Dietary Supplement|individually quick frozen red raspberries|Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
16268365|NCT00876811|Dietary Supplement|individually quick frozen red raspberries|Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.
16268366|NCT00876811|Dietary Supplement|individually quick frozen red raspberries|Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.
16268367|NCT00876798|Drug|Lixivaptan|Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
16268368|NCT00876798|Drug|Placebo|Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
16268369|NCT00876785|Other|Rye bread breakfast|A randomised, within-subject comparison design was used. Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00. Amount, type and timing of food and drink intake during the study period were standardised.
16268370|NCT00876785|Other|wheat bread based breakfast|Reference wheat bread breakfast
16268371|NCT00876772|Drug|Olanzapine|Randomized, placebo-controlled, parallel group trial to evaluate the effectiveness and tolerability of an oral dose of 10 mg Olanzapine in combination with Riluzole for the treatment of Loss of Appetite in patients with amyotrophic lateral sclerosis (ALS)
16268372|NCT00876759|Radiation|whole brain radiotherapy|WBRT in 10 fractions to a total dose of 30Gy
16268373|NCT00876759|Radiation|whole brain radiotherapy with simultaneous boost|Total dose: 10 fractions: whole brain total dose: 30Gy, metastases: total dose 50Gy
16268374|NCT00876746|Procedure|Supraclavicular vs. Infraclavicular ropivicaine infusion|Patients will be randomized to one of two groups: nerve blocks in the supraclavicular location or the infraclavicular location. Following surgery the patient will be called by study staff to assess pain scores, sleep disturbances, infusion side effects, feeling in fingers and other study outcomes.
16268375|NCT00876720|Device|rTMS - Intervention 1|Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 20Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
16268376|NCT00876720|Device|rTMS - Intervention 2|Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
16268377|NCT00876707|Device|Tecnis implant|Implant of diffractive multifocal IOL Tecnis
16268378|NCT00876707|Device|ReSTOR implant|Implant of multifocal IOL ReSTOR
16268379|NCT00876707|Device|ReZoom implant|Implant of multifocal IOL ReZoom
16268380|NCT00876694|Drug|Indacaterol 300 µg|Indacaterol 300 µg once daily (od) via SDDPI
16268381|NCT00876694|Drug|Salmeterol 50 µg|Salmeterol 50 µg twice daily (bid) via Diskus®
16268382|NCT00876681|Procedure|Popliteal catheter placed via ultrasound or electrical stimulation|Patients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff.
16268383|NCT00876655|Drug|TR-701 di-sodium phosphate salt|One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
16268384|NCT00876655|Drug|TR-701 free acid phosphate|One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
16268385|NCT00876642|Drug|Aloe vera gel|The aloe vera gel which was commercially available, contained water, aloe vera, D-panthenol, triethanolamine, carbomer 934P, hyaluronic acid, potassium sorbate, diazolidinyl urea, methylparaben, and propylparaben.
16268386|NCT00876629|Device|Pneumatic Driver|"Ten healthy volunteers will undergo MR Elastography using a pneumatic driver connected to a commercially available speaker and the stiffness of the left kidney will be measured.
~The examination will be repeated on the same volunteers at least one month later and the same stiffness measurements will be performed."
16268387|NCT00876616|Drug|Tacrolimus+Mycophenolate mofetil|FK506 4mg/d,MMF 1.0g/d
16268388|NCT00876616|Drug|Cyclophosphamide|CTX 0.75g/m2 BSA
16268389|NCT00876603|Procedure|ACDF|Anterior cervical decompression and fusion
16268390|NCT00876603|Procedure|Cervical laminoplasty|Cervical laminoplasty
16268391|NCT00876577|Drug|Moxifloxacin (Avelox, BAY12-8039)|Patients from the normal praxis routine, treated with Moxifloxacin injection with/without sequential tablet treatment according to the local product information
16268392|NCT00876564|Other|Trauma patients|
16268393|NCT00876551|Procedure|Endoscopic vacuum assisted closure|"Endoscopic debridement of wound using a regular biopsy forceps.
~Introduction via the nose and oral exteriorization of a silicone duodenal tube (Freka Tube, 15 Ch, Fresenius Kabi, Bad Homburg v.d. H. Germany)
~Fixation of a polyurethane foam (sponge, pore size 400-600 µm, KCI, Wiesbaden Germany) to the tip of the duodenal tube with a mersilene suture (0,35mm, Johnson & Johnson, St-Stevens-Woluwe, Belgium).
~Trimming of the sponge to the specific wound size.
~Endoscopic placement of the sponge in the intrathoracic leak with a grasping forceps (Olympus, Germany)
~Application of continuous suction of 125mmHg using vacuum pump (KCI, Wiesbaden Germany).
~Sponge exchange twice a week until wound grounds are clean and closed"
16268394|NCT00876538|Drug|Olesoxime (TRO19622)|2 capsules of TRO19622 (330 mg) once day with the noon meal
16268395|NCT00876538|Drug|Placebo Control|Placebo Control 2 capsules once day with the noon meal
16268396|NCT00876525|Device|Freedom SOLO|The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.
16268397|NCT00876499|Behavioral|Questionnaire|A total of 8 questionnaires regarding fatigue taking approximately 30 minutes each, given before radiation therapy, weekly during, and after completion.
16268398|NCT00876486|Drug|Genexol-PM®|Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
16268399|NCT00876486|Drug|Genexol®|Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
16268400|NCT00876473|Procedure|CPAP system|"Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange
~CPAP systems:
~Continuous high-flow CPAP with fixed value PEEP valve
~Continuous high-flow CPAP with Boussignac valve
~Demand flow CPAP supplied by ventilator"
16268401|NCT00876460|Drug|BIBF 1120 M + docetaxel M|BIBF 1120 Medium dose bid + docetaxel 60 mg/m2
16268402|NCT00876460|Drug|BIBF 1120 M + docetaxel H|BIBF 1120 Medium dose bid + docetaxel 75mg/m2
16268403|NCT00876460|Drug|BIBF 1120 H + docetaxel H|BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2
16268404|NCT00876460|Drug|BIBF 1120 L + docetaxel M|BIBF 1120 Low dose bid + docetaxel 60 mg/m2
16268405|NCT00876460|Drug|BIBF 1120 H + docetaxel M|BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2
16268406|NCT00876447|Biological|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
16268407|NCT00876447|Biological|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
16268408|NCT00876434|Drug|Sirolimus|
16268409|NCT00876421|Drug|Placebo|Placebo / 12 weeks
16268410|NCT00876421|Drug|Tolterodine|4mg / 12 weeks
16268411|NCT00876421|Drug|ONO-8539|low dose / 12 weeks
16268412|NCT00876421|Drug|ONO-8539|medium dose / 12 weeks
16268413|NCT00876421|Drug|ONO-8539|higher dose / 12 weeks
16268414|NCT00876395|Drug|Everolimus|Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).
16268415|NCT00876395|Drug|Placebo|Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).
16268416|NCT00876395|Drug|Trastuzumab|Trastuzumab, 2 mg/kg weekly was used intravenously.
16268417|NCT00876395|Drug|Paclitaxel|Paclitaxel, 80 mg/m2 weekly was used intravenously.
16268418|NCT00876356|Dietary Supplement|Conjugated Linoleic Acid (CLA)|CLA 4.5g/day in three divided doses p.o. for 12 weeks
16268419|NCT00876356|Dietary Supplement|Olive oil|Olive oil 4.5g/day x 12 weeks
16268420|NCT00876343|Drug|Aripiprazole (Fixed dose)|administered orally once daily, 3 mg daily, 6 weeks
16268421|NCT00876343|Drug|Aripiprazole (Titrated dose)|administered orally once daily, 3 to 15 mg daily, 6 weeks
16268422|NCT00876343|Drug|Placebo|administered orally once daily, 6 weeks
16268423|NCT00876330|Other|Clinical Decision Support for Hypertension|Clinical decision support alerts for antihypertensive therapy
16268424|NCT00876330|Other|Automated Telephone Outreach for Antihypertensive Therapy|Automated Telephone Outreach to patients for antihypertensive medication therapy.
16268425|NCT00876330|Other|Clinical Decision Support for Lipid-lowering Therapy|Clinical Decision Support alerts for Lipid-lowering medication therapy.
16268426|NCT00876330|Other|Automated Telephone Outreach for Lipid-lowering Therapy|Automated telephone outreach to patients for Lipid-lowering medication therapy.
16268427|NCT00876317|Drug|Etoricoxib 60 mg|Etoricoxib 60 mg per oz per day for 14 days
16268428|NCT00876317|Drug|Etoricoxib 90 mg|Etoricoxib 90 mg per oz for 14 days
16268429|NCT00876304|Drug|PF-04802540|Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data
16268430|NCT00876304|Drug|Placebo|Placebo capsules every 12 hours for 10 days
16268431|NCT00876291|Dietary Supplement|Lactobacillus GG (probiotic )|LGG capsules: each cp containing 3 × 109 colony forming units, CFU
16268432|NCT00876291|Dietary Supplement|Placebo|placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
16268433|NCT00876278|Device|*AT.Smart 46LC|Primary implantation of *AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.
16268434|NCT00876265|Device|Belotero|Belotero, injectable hyaluronic acid gel device, implanted into the nasolabial fold in the Treatment Phase of the study (multiple injections of 0.1 to 0.2 mL, up to a maximum of 3 mL over 2 treatment sessions). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered.
16268435|NCT00876265|Device|Zyplast|Zyplast Collagen Implant, an injectable dermal collagen device, implanted into the nasolabial fold in the Treatment Phase of the study (average injection of 1.0 mL). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered. Zyplast was obtained by each site from commercially available supplies.
16268436|NCT00876252|Biological|IC43|
16268437|NCT00876252|Drug|Placebo|NaCl
16268438|NCT00876226|Drug|Citalopram|"Citalopram pharmacokinetics will be studies in subjects with short bowel syndrome.
~Citalopram 20mg orally will be given to the subjects and on the seventh day blood will be drawn at hours 0,1,2,3,4,6,8,12,16 and 24 hours post-dose."
16268439|NCT00876200|Drug|Minoxidil|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
16268440|NCT00876200|Drug|Placebo|"Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
~Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more."
16268441|NCT00876187|Biological|Tanezumab 20 mg IV|2 IV administrations of tanezumab 20 mg at an 8 week interval
16268442|NCT00876187|Drug|Placebo for naproxen|Oral placebo for naproxen twice a day for 16 weeks
16268443|NCT00876187|Biological|Tanezumab 10 mg IV|2 IV administrations of tanezumab 10 mg at an 8 week interval
16268444|NCT00876187|Drug|Placebo for naproxen|Oral placebo for naproxen twice a day for 16 weeks
16268445|NCT00876187|Biological|Tanezumab 5 mg IV|2 IV administrations of tanezumab 5 mg at an 8 week interval
16268446|NCT00876187|Drug|Placebo for naproxen|Oral placebo for naproxen twice a day for 16 weeks
16268447|NCT00876187|Biological|Placebo for tanezumab|2 IV administrations of placebo for tanezumab at an 8 week interval
16268448|NCT00876187|Drug|Naproxen|Oral naproxen 500 mg twice a day for 16 weeks
16268449|NCT00876187|Biological|Placebo for tanezumab|2 IV administrations of placebo for tanezumab at an 8 week interval
16268450|NCT00876187|Drug|Placebo for naproxen|Oral placebo for naproxen twice a day for 16 weeks
16268451|NCT00876174|Procedure|Blood sampling of peripheral blood mononuclear cells|Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy
16268452|NCT00876174|Procedure|Blood draw, 20ml peripheral blood mononuclear cells|One time blood draw of 20 ml
16268453|NCT00876161|Drug|DAS181|DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 5 mg, 10 mg and 20 mg.
16268454|NCT00876161|Drug|Lactose|
16268538|NCT00875446|Drug|GSK1223249|I.V Infusion
16268455|NCT00876135|Drug|Ventolin|Ventolin or Placebo will be given before the 4 field tests (2 with ventolin in prevention and 2 with placebo in prevention) and 2 eucapnic voluntary hyperpnoea tests (one preceded by Ventolin and one preceded by Placebo).
16268456|NCT00876122|Drug|GDC-0941|Escalating oral dose
16268457|NCT00876109|Drug|GDC-0941|GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.
16268458|NCT00876096|Other|Catch of blood then PCR|To optimize the technology of extraction of nucleic acids of origin fongique by collaborating with the laboratories of Parasitologie and Mycology of the TEACHING HOSPITAL of Rennes and Toulouse.
16268459|NCT00876083|Drug|Ultravist (Iopromide, BAY86-4877)|Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
16268460|NCT00876057|Procedure|Total abdominal hysterectomy|Total abdominal hysterectomy
16268461|NCT00876057|Procedure|Subtotal abdominal hysterectomy|Subtotal abdominal hysterectomy
16268462|NCT00876044|Drug|aflibercept (AVE0005)|Intravenous route
16268463|NCT00876044|Drug|placebo|Intravenous route
16268464|NCT00876031|Drug|trofosfamide, idarubicin, etoposide|oral maintenance therapy for 6 months
16268465|NCT00876018|Other|Nutritional supplement|Fortified nutritional powder
16268466|NCT00876018|Other|Placebo|Un-fortified nutritional powder
16268467|NCT00876005|Other|Oxygen by mask|Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
16268468|NCT00876005|Other|Oxygen by mask|Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
16268469|NCT00875992|Device|ETN with ASLS|Angle stable locking of ETN using ASLS
16268470|NCT00875992|Device|ETN locked with conventional locking bolts|Conventional surgical procedure
16268471|NCT00875979|Drug|Trastuzumab emtansine [Kadcyla] 3.0 mg/kg|Trastuzumab emtansine was provided as a single-use lyophilized formulation.
16268472|NCT00875979|Drug|Trastuzumab emtansine [Kadcyla] 3.6 mg/kg|Trastuzumab emtansine was provided as a single-use lyophilized formulation.
16268473|NCT00875979|Drug|Pertuzumab 420 mg|Pertuzumab was provided as a single-use formulation.
16268474|NCT00875966|Drug|Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC|
16268475|NCT00875966|Drug|Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer|Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions
16268476|NCT00875953|Procedure|standard neck dissection|standard surgical technique
16268477|NCT00875953|Procedure|Harmonic Scalpel Dissection|harmonic scalpel used for neck dissection after flaps are raised.
16268478|NCT00875940|Other|Diagnostic imaging procedures.|
16268479|NCT00875927|Other|no scraping microcapsules|1, 4 grams isomalt candy containing no scraping microcapsules
16268480|NCT00875927|Other|scraping microcapsules containing inert TCP microcapsules|1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules
16268481|NCT00875927|Other|scraping microcapsules containing Propolis|1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules
16268482|NCT00875927|Other|scraping microcapsules containing and Zinc|1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules
16268483|NCT00875927|Other|scraping microcapsules containing Propolis and Zinc|1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules
16268484|NCT00875914|Procedure|RF-ablation|4mm-tip catheter manually guided vs magneticallly navigated
16268485|NCT00875901|Radiation|Peripherally located lung tumor|12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)
16268486|NCT00875901|Radiation|Centrally located lung tumor|6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)
16268487|NCT00875888|Device|continuous venovenous hemodialysis|dialysate flow rate 35 ml/h/kg. Blood flow rate should be aimed at 200 ml/min, but not less than 150 ml/min. Bicarbonate- or lactate-buffered solutions will be used as dialysis fluids. Study dialyzers will be changed routinely every 24 h or earlier if the filter is obstructed by clotting.
16268488|NCT00875875|Drug|Rifaximin|Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
16268489|NCT00875862|Procedure|Interscalene catheter with Ropivicaine or normal saline|Patients will be randomized to one of two groups: 0.2% Ropiviciane or normal saline in the infusion pump, following a shoulder manipulation for adhesive capsulitis. The patients will be followed by doctors and study staff to assess pain, range-of-motion and quality-of-life.
16268490|NCT00875849|Biological|cetuximab|
16268491|NCT00875849|Drug|cisplatin|
16268492|NCT00875849|Radiation|radiation therapy|
16268493|NCT00875836|Drug|Buspirone|Flexible dose, up to 60 mg daily
16268494|NCT00875836|Drug|Placebo|Flexible dose, up to 60 mg daily
16268495|NCT00875797|Dietary Supplement|parenteral glutamine|Dipeptiven, Fresenius Kabi, Graz, Austria was given intravenously through central venous line in a dose up to 30 g per day
16268496|NCT00875797|Dietary Supplement|enteral glutamine|Alitraq, Abbott Laboratories, B.W. Zwolle, the Netherlands was given via nasogastric tube as continuous infusion of enteral diet, dose up to 30 g per day
16268497|NCT00875784|Drug|TREXIMA™|sumatriptan succinate / naproxen sodium tablet
16268498|NCT00875784|Drug|IMITREX® (4mg)|sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System®
16268499|NCT00875784|Drug|IMITREX® (6mg)|sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System®
16268500|NCT00875784|Drug|IMITREX Tablet 100mg|IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
16268501|NCT00875771|Drug|Capecitabine+Irinotecan+Bevacizumab|"Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks
~Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks
~Bevacizumab: 5 mg/kg day 1, every 2 Weeks
~Treatment will be given until disease progression or unacceptable toxicity."
16268539|NCT00875433|Drug|BIBW 2992|patients to receive continuous oral daily dosing of BIBW 2992
16268540|NCT00875420|Drug|RAD1901|10 mg Oral once a day for 28 days.
16268541|NCT00875420|Drug|RAD1901|25 mg Oral once a day for 28 days
16268502|NCT00875758|Procedure|Removal of CSF through ventricular access device|Ventricular access devices (VADs) are surgically implanted when cranial ultrasound measures reach treatment group-specific criteria. For the standard-threshold arm, VADs will be implanted when the age-adjusted ventricular index shows the ventricles to be at the 97th percentile + 2 standard deviations. Cerebrospinal fluid is then removed from the VADs 1-3 times daily as required to maintain ventricles within these parameters.
16268503|NCT00875758|Procedure|Removal of CSF through a ventricular access device|Ventricular access devices (VADs) are surgically implanted when cranial ultrasound measures reach treatment group-specific criteria. For the standard-threshold arm, VADs will be implanted when the age-adjusted ventricular index shows the ventricles to be at the 97th percentile. Cerebrospinal fluid is then removed from the VADs 1-3 times daily as required to maintain ventricles within these parameters.
16268504|NCT00875745|Drug|Sorafenib-Vorinostat|Patients will be entered in successive cohorts. The first cohort will receive Sorafenib at 400 mg bid (800 mg daily) and Vorinostat at 100 mg bid (200 mg daily).
16268505|NCT00875732|Device|Bi Ventricular Pacing|
16268506|NCT00875732|Device|Right Ventricular Pacing|
16268507|NCT00875719|Device|Oxygen concentrators versus constant flow axygen|Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.
16268508|NCT00875719|Device|oxygen concentrator|comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
16268509|NCT00875706|Behavioral|Educational Intervention|The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia.
16268510|NCT00875693|Drug|CPX-351|CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
16268511|NCT00875680|Device|autoPPC|To test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography.
16268512|NCT00875667|Drug|Lenalidomide|"For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
~For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity."
16268513|NCT00875667|Drug|Investigators choice single agent|Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
16268514|NCT00875654|Genetic|Autologous mesenchymal stem cells|Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke
16268515|NCT00875641|Other|Health Insurance Database|Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.
16268516|NCT00875628|Drug|PF-00868554 or Placebo|Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
16268517|NCT00875628|Drug|PF-00868554 or Placebo|Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
16268518|NCT00875628|Drug|PF-00868554 or Placebo|Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days
16268519|NCT00875615|Drug|Carboplatin|Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
16268520|NCT00875615|Drug|Cisplatin|Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
16268521|NCT00875615|Drug|Sorafenib|Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
16268522|NCT00875602|Device|EverOn (EarlySense) contactless monitoring device|Hospitalized patients on the study unit are monitored by a contactless device
16268523|NCT00875563|Device|Zenith(R) Fenestrated AAA Endovascular Graft|The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
16268524|NCT00875550|Drug|Dexmedetomidine|Study drug titrated up or down to maintain target UMSS range.
16268525|NCT00875550|Drug|Midazolam|Rescue medication for sedation according to UMSS scores
16268526|NCT00875550|Drug|Fentanyl|Rescue medication for pain based on UMSS scores
16268527|NCT00875550|Drug|Morphine|Rescue medication for pain based on UMSS scores.
16268528|NCT00875537|Other|Capsaicin oral gel 0.025%|Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
16268529|NCT00875537|Other|Capsaicin oral gel 0.01%|Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
16268530|NCT00875524|Biological|CYD dengue vaccine serotypes (1, 2, 3, 4).|0.5 mL, Subcutaneous
16268531|NCT00875524|Biological|Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide|Each at 0.5 mL, Subcutaneous, respectively
16268532|NCT00875498|Procedure|active iTBS|"Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.
~80% MT, 20 sessions of 6 minutes, 2 per day"
16268533|NCT00875498|Procedure|sham iTBS|iTBS placebo (placebo coil)
16268534|NCT00875485|Procedure|Blood sampling|Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
16268535|NCT00875485|Biological|Additional challenge dose|If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.
16268536|NCT00875459|Drug|VIAject™|Subcutaneous injection 25 IU/mL
16268537|NCT00875446|Drug|PLACEBO|Placebo
16268544|NCT00875420|Drug|Placebo|Placebo Oral once a day for 28 days
16268545|NCT00875407|Other|Scintigraphy in 123I-IBZM|
16268546|NCT00875394|Drug|sitagliptin phosphate|sitagliptin 100 mg Once a day (QD) for 24 weeks
16268547|NCT00875394|Drug|Comparator: metformin|metformin 850 mg Twice a day (BID) for 24 weeks
16268548|NCT00875394|Drug|Comparator: metformin|metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
16268549|NCT00875394|Drug|Comparator: Antidiabetic Standard of Care|Patient can take any oral antidiabetic drug (other than metformin)
16268550|NCT00875368|Drug|maraviroc|maraviroc dose dependent on co-medication
16268551|NCT00875368|Drug|Placebo|Placebo drug
16268552|NCT00875355|Drug|temozolomide|Given orally
16268553|NCT00875355|Radiation|radiation therapy|Patients undergo radiotherapy
16268554|NCT00875342|Drug|DCS|1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
16268555|NCT00875342|Other|Placebo|2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
16268556|NCT00875316|Drug|Cogane™ (PYM50028)|Orally active neurotrophic factor inducer
16268557|NCT00875303|Behavioral|Play Nicely program|The intervention was the Play Nicely program, a multimedia educational program. Permission to demonstrate the program to multiple viewers was obtained from the copyright holder. English speaking caregivers viewed the 2nd English language edition and Spanish speaking caregivers viewed the Spanish edition. In the program, there are 16 options (20 options in the Spanish version) to respond to the hypothetical situation of witnessing a young child have hurtful behavior toward another child. Caregivers in the intervention group were instructed to view 4 of the interactive options of their choosing. On average, it takes 1 minute to view one option. Parents in the control group received routine primary care with their pediatrician.
16268558|NCT00875303|Behavioral|Control|Routine primary care.
16268559|NCT00875290|Device|Real-time glucose sensor|Children assigned to this intervention will use a real-time sensor continuously
16268560|NCT00875277|Drug|LEO 29102 cream|
16268561|NCT00875277|Drug|LEO 29102 Cream Vehicle|
16268562|NCT00875277|Drug|Betamethasone Dipropionate Cream|
16268563|NCT00875277|Drug|LEO 29102 Plus Calcipotriol Cream|
16268564|NCT00875277|Drug|LEO 29102 Plus Betamethasone Dipropionate|
16268565|NCT00875277|Drug|Daivobet® Ointment|
16268566|NCT00875264|Drug|CEP-11981 (kinase inhibitor)|Patients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days. This 42-day (6-week) period will constitute 1 cycle. The starting dose for the study will be 3 mg/m2. Dose escalation from this starting dose follows a modified Fibonacci sequence.
16268567|NCT00875251|Device|body composition|Measurements of body composition using 2 differents devices: Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) air-displacement plethysmography in the PEA POD System (Life Measurement).
16268568|NCT00875238|Biological|trastuzumab|
16268569|NCT00875238|Drug|doxorubicin hydrochloride|
16268570|NCT00875238|Genetic|polymorphism analysis|
16268571|NCT00875238|Other|laboratory biomarker analysis|
16268572|NCT00875238|Other|questionnaire administration|
16268573|NCT00875238|Procedure|assessment of therapy complications|
16268574|NCT00875238|Procedure|magnetic resonance imaging|
16268575|NCT00875225|Behavioral|DVD|Control group will receive usual care DVD from health professionals
16268576|NCT00875225|Behavioral|Intervention DVD|Intervention group will receive intervention DVD with patient stories and information from health care professionals
16268577|NCT00875212|Drug|calcium glycerophosphate|use of a dentifrice containing CaGP (0.13%) and no fluoride
16268578|NCT00875212|Drug|no active ingredient|dentifrice without calcium glycerophosphate and no fluoride
16268579|NCT00875212|Drug|fluoride|use of a dentifrice containing fluoride (1500ppm) only
16268580|NCT00875212|Drug|CAGP + fluoride|calcium glycerophosphate and fluoride dentifrice
16268581|NCT00875199|Behavioral|contingency management|Prize-based contingency management for weight loss
16268582|NCT00875199|Behavioral|weight loss manual-guided individual therapy sessions|once weekly counseling session with research staff
16268583|NCT00875186|Other|aerobic endurance training|participants exercises 2 times weekly for 1 hour (aerobic endurance training)
16268584|NCT00875186|Other|aerobic endurance training|participants exercised 1 time weekly for 1 hour (aerobic endurance training)
16268585|NCT00875173|Drug|Selenium|selenium as a drug according to Brazilian regulation laws
16268586|NCT00875173|Drug|Placebo (for Selenium)|Placebo with similar flavor, smell and colour.
16268587|NCT00875160|Drug|AT2101|225mg (nine 25mg capsules total dose) to be taken by mouth every day for 9 days (Study Days 1, 3-10)
16268588|NCT00875147|Drug|bevacizumab|Neoadjuvant chemotherapy with bevacizumab
16268589|NCT00875134|Other|Verbal prompt|Patient hears a voice recording
16268590|NCT00875134|Other|Skin Stimulus|Patient receives either a skin stimulus
16268591|NCT00875108|Drug|VIAject™|Subcutaneous injection 25 IU/mL
16268592|NCT00875082|Drug|Montelukast|Montelukast, chewing tablets 5mg, once daily, 8 weeks
16268593|NCT00875082|Drug|placebo|placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks
16268594|NCT00875069|Other|Ethanol|Dialysis catheter lock performed after renal replacement therapy session. Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.
16268595|NCT00875056|Drug|Vorinostat|Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
16268596|NCT00875030|Drug|artesunate sachets|single dose 50 mg (2 X 25 mg) artesunate sachets
16268597|NCT00875030|Drug|Arsuamoon|single dose 50 mg arsuamoon tablet
16268598|NCT00875017|Drug|Lanthanum Carbonate|1 x 1000mg tablet
16268599|NCT00875017|Drug|Sevelamer|3 x 800mg tablets
16268600|NCT00875004|Biological|epoetin beta|
16268601|NCT00875004|Drug|systemic chemotherapy|
16268602|NCT00875004|Procedure|quality-of-life assessment|
16268603|NCT00874978|Drug|lenalidomide|Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles.
16268604|NCT00874965|Device|Electrostimulation|50Hz; 0.4 ms; 30 min; 5 times / week
16268605|NCT00874965|Device|Sham stimulation|30 min; 5 times / week
16268606|NCT00874939|Drug|MK-0249 7.5 mg|4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period
16268607|NCT00874939|Drug|MK-0249 25 mg|5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
16268608|NCT00874939|Drug|Donepezil 5mg|One 5 mg tablet, single oral dose during each crossover period
16268609|NCT00874939|Drug|Placebo to MK-0249|Five tablets, single oral dose during each crossover period
16268610|NCT00874939|Drug|Placebo to Donepezil|One over-encapsulated capsule, single oral dose during each crossover period
16268611|NCT00874926|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Haemophilia A patients
16268612|NCT00874913|Device|measurement of ocular blood flow|measurement of ocular blood flow with a laser Doppler flowmeter
16268613|NCT00874900|Other|Educational game|"Quest for the Code is an educational asthma computer game. Participants randomized to this intervention will have access to the game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department."
16268614|NCT00874900|Other|Educational game + motivational interview|"Quest for the Code is an educational asthma computer game. Participants randomized to this intervention will have access to this game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department (ED).Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques."
16268615|NCT00874900|Other|Motivational interview|Participant randomized to this group will receive standard care for the treatment of their asthma, including an education asthma booklet developed by Seattle Children's. Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques.
16268616|NCT00874887|Drug|moxifloxacin 0.5% HCI ophthalmic solution|1 drop in study eye three times a day for 14 days
16268617|NCT00874887|Drug|gatifloxacin ophthalmic solution 0.3%|1 drop in study eye four times a day for 14 days
16268618|NCT00874874|Drug|sorafenib tosylate|
16268619|NCT00874861|Biological|Peptide vaccine + Poly-ICLC|"Subcutaneously in right or left upper arms with intact draining axillary nodes. Each will be injected to the same location in the same arm as the previous vaccine was administered. In case of no intact axillary lymph nodes as draining nodes, vaccines will be administered in the upper thigh on the same side with intact inguinal lymph nodes.
~Vaccine will be administered on weeks 0,3,6,9,12,15,18 and 21. Poly-ICLC First course(20 mg/kg i.m., up to 1640 µg/injection) will be administered on an outpatient basis in the Clinical & Translational Research Center (CTRC)the day of the first GAA/TT-vaccine and on day 4 after the vaccine. For each of the repeated vaccinations (on Weeks 3,6,9,12,15,18 and 21) poly-ICLC will be administered on day of the vaccine and on day 4 after the vaccine."
16268620|NCT00874848|Biological|Imprime PGG Injection|4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
16268621|NCT00874848|Biological|Cetuximab|initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
16268622|NCT00874848|Drug|Paclitaxel|200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
16268623|NCT00874848|Drug|Carboplatin|dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
16268624|NCT00874835|Device|EndoSaver™ Corneal Endothelium Delivery Instrument|Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.
16268625|NCT00874809|Device|CGMS with an insulin pump using rapid acting insulin|To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin
16268626|NCT00874796|Drug|GS-9450|Taken as one capsule by mouth once daily
16268627|NCT00874796|Drug|Placebo|Taken as one placebo capsule (matching in appearance to GS-9450 capsules) by mouth once daily
16268628|NCT00874770|Drug|Daclatasvir|Tablets, oral, 3 mg, Daily, 48 weeks
16268629|NCT00874770|Drug|Daclatasvir|Tablets, oral, 10 mg, Daily, 48 weeks
16268630|NCT00874770|Drug|Daclatasvir|Tablets, oral, 60 mg, Daily, 48 weeks
16268631|NCT00874770|Drug|Placebo|Tablet, oral, 0 mg, Daily 48 weeks
16268632|NCT00874770|Drug|Peginterferon alpha-2a|Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
16268633|NCT00874770|Drug|ribavirin|Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
16268634|NCT00874744|Drug|Bevacizumab|1.25mg bevacizumab (0.05ml)
16268635|NCT00874744|Drug|Triamcinolone acetonide|4.0 mg Triamcinolone acetonide injection
16268636|NCT00874731|Drug|Ridaforolimus 100 mg|Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2.
16268637|NCT00874731|Drug|Ridaforolimus 40 mg|Part 2 (optional): Ridaforolimus 40 mg (4 x 10 mg tablets) was received on a regimen of daily oral doses for 5 consecutive days followed by 2 days off-drug.
16268638|NCT00874731|Drug|Placebo|Part 1: A single oral dose of placebo (10 x placebo tablets) was given on Day 1.
16268639|NCT00874718|Behavioral|educational program|6-week educational program for prevention of occupational musculoskeletal diseases.
16268640|NCT00874718|Behavioral|General education|Non-specific educational program for general health.
16268641|NCT00874692|Other|BMS and sterilisation programme|BMS with reduced hot water temperature and sterilisation programme
16268642|NCT00874679|Drug|Levitra (Vardenafil, BAY38-9456)|Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
16268643|NCT00874666|Other|crushed garlic clove|1 gram crushed garlic in gelatin capsules, one dose once every 2-16 weeks
16268644|NCT00874666|Dietary Supplement|garlic powder tablet|tablets, dose to contain 1 gram of garlic powder, consume one dose once every two weeks for up to 52 weeks
16268645|NCT00874653|Drug|Levonorgestrel (Mirena, BAY86-5028)|Women using Mirena for intrauterine treatment of menorrhagia
16268646|NCT00874640|Biological|Gadobutrol (Gadovist, BAY86-4875)|Patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium gadobutrol
16268647|NCT00874627|Other|Milk|sublingual administration of milk
16268648|NCT00874627|Other|Milk|placebo
16268695|NCT00874315|Drug|tacrolimus|0.03 mg/kg/day as continuous infusion or 12 hour divided doses
16268649|NCT00874614|Radiation|Ultratrace® Iobenguane I131|Each subject will be administered 3 mCi to 6 mCi Ultratrace® Iobenguane I 131, referred to as the Imaging Dose, to confirm that subject meets radiological entry criteria and to establish dosimetry. All subjects meeting entry criteria will then receive the investigational product referred to as the Therapeutic Dose (500 mCi or 8 mCi/kg if the subject weighs 62.5 kg or less) of Ultratrace Iobenguane I 131, followed by imaging at 7 days post infusion or upon discharge from isolation. The Therapeutic Doses will be adjusted equally if warranted by results of the dosimetry evaluation. At least 3 months later, subjects will receive the second Therapeutic Dose.
16268650|NCT00874601|Drug|Diovan® (valsartan)|"The valsartan will be initially given 80 mg of Diovan® (valsartan) per oral once daily in the morning on day 1, and flexibly will be adjusted to a dose of 80 -320 mg per day during next 6 days if more than 30% of SBPs measured at least 4 times in a day will not get the target level of SBPs.
~In those patients not achieving target level of blood pressure (more than 15% reduction of initial blood pressure or below 145 mmHg of systolic blood pressure), an additional antihypertensive drugs (diuretics, beta blockers) can be given despite of Valsartan 320 mg. If the BP is considered to be low enough, dose of valsartan can be decreased to 40 mg per day. If the administration of valsartan is judged to be inappropriate by duty doctor due to any reasons, it can be stopped and the reasons will be recorded."
16268651|NCT00874588|Biological|HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2|Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 1.0mg and 3.0mg.
16268652|NCT00874575|Dietary Supplement|Placebo|
16268653|NCT00874575|Dietary Supplement|Vitamin D|
16268654|NCT00874575|Dietary Supplement|Beta-hydroxy-Beta-methylbutyrate|
16268655|NCT00874575|Drug|Beta-hydroxy-Beta-methylbutyrate and Vitamin D|
16268656|NCT00874562|Drug|Corticosteroid|Initial dose of corticosteroid given intravenously. After the first dose, corticosteroid will be taken orally every 8 hours for the duration of the five-day period
16268657|NCT00874562|Drug|Rapamycin|Taken orally mixed with water or orange juice
16268658|NCT00874549|Biological|Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide|0.5 mL, Subcutaneous
16268659|NCT00874549|Biological|Menactra®: Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16268660|NCT00874549|Biological|Menactra®: Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL. Intramuscular
16268661|NCT00874549|Biological|Menactra®: Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16268662|NCT00874536|Dietary Supplement|omega-3 fatty acid alpha-linolenic acid (ALA)|3 grams of ALA-containing plant oil
16268663|NCT00874536|Dietary Supplement|Placebo|
16268664|NCT00874523|Drug|atazanavir plus raltegravir|atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks then atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks
16268665|NCT00874523|Drug|atazanavir plus raltegravir|atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks then atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks
16268666|NCT00874510|Behavioral|Mandatory Naps|As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am
16268667|NCT00874497|Drug|tetomilast|Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
16268668|NCT00874497|Drug|placebo|Placebo for 104 weeks (2 years)
16268669|NCT00874484|Drug|Clexane (enoxaparin)|One arm receives enoxoparin, second arm receives saline
16268670|NCT00874458|Procedure|magnetic resonance imaging|
16268671|NCT00874458|Procedure|radiomammography|
16268672|NCT00874458|Procedure|ultrasound imaging|
16268673|NCT00874445|Device|ICD/ CRT-D|Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.
16268674|NCT00874432|Drug|angiotensin converting enzyme inhibitor|Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
16268675|NCT00874432|Drug|lisinopril|1 x 40 mg per day
16268676|NCT00874419|Drug|erlotinib|erlotinib 150 mg oral, once a day
16268677|NCT00874419|Drug|gemcitabine/carboplatin|gemcitabine 1000mg/m2 on d1,8 with carboplatin AUC=5 on d1 intravenously, every 3 weeks, up to 4 cycles
16268678|NCT00874406|Drug|tac + folfox4|tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4
16268679|NCT00874406|Drug|folfox4|folfox4 will be done within 28 days after liver resection
16268680|NCT00874393|Drug|Dopamine|Dopamine
16268681|NCT00874393|Drug|Hydrocortisone|Hydrocortisone
16268682|NCT00874393|Drug|Infusion Placebo|Dextrose (D5W)
16268683|NCT00874393|Drug|Syringe Placebo|Normal saline
16268684|NCT00874380|Other|Increasing total fiber intake in patient's diet|Second counsel patients biweekly about their compliance with a high fiber diet, target being 25 to 30 gm of fiber a day.Follow them for a period of 2 years and assess if their is any significant decrease in their cardiovascular events and profile, in addition to assessing the effect of high fiber on kalemia.
16268685|NCT00874354|Drug|Intracoronary Transplantation of Bone Marrow Stem Cells|Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.
16268686|NCT00874341|Other|Fruit and vegetable intervention|Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)
16268687|NCT00874328|Drug|Irinotecan|Irinotecan iv D1 q 3 weeks until maximum 6 cycles
16268688|NCT00874328|Drug|Cisplatin|cisplatin 60mg/m2 iv D1 q 3weeks until maximum 6 cycles
16268689|NCT00874328|Drug|TS-1 (S-1)|TS-1 po D1~D14 q 3 weeks until maximum 6 cycles
16268690|NCT00874315|Other|anti-thymocyte globulin|2.5 mg/kg/day for 4 doses on day -3, -2 , -1 and day +2.
16268691|NCT00874315|Drug|busulfan|0.8 mg/kg/dose for total of 8 doses.
16268692|NCT00874315|Drug|cyclosporine|1.5 mg/kg/dose every 12 hours.
16268693|NCT00874315|Drug|fludarabine phosphate|30 mg/m2/day for 5 days.
16268694|NCT00874315|Drug|mycophenolate mofetil|15 mg/kg/dose every 8 hours
16268696|NCT00874315|Procedure|allogeneic hematopoietic stem cell transplantation|Donor stem cell transplantation from HLA matched sibling donor or an unrelated donor.
16268697|NCT00874302|Drug|Proellex|One 25mg capsule taken orally once every day.
16268698|NCT00874302|Drug|Proellex|Two 25mg capsules Proellex (50mg) taken orally once every day
16268699|NCT00874289|Other|NGAL kit|Kit to test NGAL levels in heart failure patients
16268700|NCT00874276|Drug|Dichloroacetate (DCA)|Dichloroacetate 2.5.ug/kg will be administered for five days in the clinical research center. On day 5 with the dose of DCA a pharmacokinetics test will be performed for 24 hours. 30 days later the individuals will return to the clinic and receive Dichloroacetate 25mg/kg (clinical dose) for five days. On day 1 and day 5 Pharmacokinetics will be performed to determine the relationship between DCA metabolism and haplotype.
16268701|NCT00874276|Genetic|Genetic Marker on Chromosome 14q24.3|Individuals were genotyped at the beginning of the study and their haplotypes were defined. The study is looking at individuals with genetic markers on Chromosome 14q24.3 to determine if there will be a difference in how the DCA will be metabolized.
16268702|NCT00874250|Device|GORE CTAG Device|Endovascular aortic stent-graft
16268703|NCT00874237|Drug|Inhaled loxapine|Inhaled Staccato Loxapine 10 mg single dose
16268704|NCT00874237|Drug|Inhaled placebo|Inhaled Staccato placebo single dose
16268705|NCT00874237|Drug|Oral moxifloxacin|Oral moxifloxacin 400 mg
16268706|NCT00874237|Drug|Oral placebo|Oral placebo similar in appearance to moxifloxacin 400 mg
16268707|NCT00874224|Procedure|laparoscopic left lateral hepatic sectionectomy|laparoscopic left lateral hepatic sectionectomy
16268708|NCT00874224|Procedure|open left lateral hepatic sectionectomy|open left lateral hepatic sectionectomy
16268709|NCT00874211|Procedure|assessment of therapy complications|By dental and medical assessments.
16268710|NCT00874198|Procedure|Ventriculo-peritoneal Shunt|Surgical implantation of a ventriculo-peritoneal cerebrospinal fluid shunt with an adjustable valve system using the Codman-Hakim programmable valve system [pressure settings: 30 - 200 mmH20]
16268711|NCT00874172|Drug|Rapid optimized analgesic strategy|"Oral treatment :
~1 gr Acetaminophen 20 mg of nefopam delivered on a lump sugar Nitrous oxide inhalation with initial output of 9 L/min subsequently Intravenous morphine bolus of 3 mg Nitrous oxide interruption after 5 minutes of the initial morphine bolus"
16268712|NCT00874172|Drug|current analgesic strategy|"paracetamol 1 g per os nasal oxygen therapy
~1 amp of morphine 10 mg / 10 cc of glucose 5 %, by repeated bolus administration"
16268713|NCT00874159|Other|No treatment given|Subject will only fill out a questionaire when entering the observational study.
16268714|NCT00874146|Genetic|Fluorescent in-situ hybridization (FISH)|Dual color FISH test to assess ratio of HER2/neu amplification
16268715|NCT00874133|Procedure|Acupuncture|Acupuncture treatment for 12 weeks.
16268716|NCT00874133|Drug|Motilium|20 mg motilium thrice daily
16268717|NCT00874120|Drug|Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg|Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.
16268718|NCT00874120|Drug|Placebo|Placebo taken twice daily (12 hours apart) for 7 days.
16268719|NCT00874107|Biological|Imprime PGG® Injection|4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
16268720|NCT00874107|Biological|Bevacizumab|15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
16268721|NCT00874107|Drug|Paclitaxel|200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
16268722|NCT00874107|Drug|Carboplatin|AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
16268723|NCT00874094|Biological|Platelet rich fibrin matrix|0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.
16268724|NCT00874068|Other|InFat™ based infant formula|high sn-2 palmitic acid oil based infant formula
16268725|NCT00874068|Other|Standard vegetable oil based infant formula|standard vegetable oil based infant formula
16268726|NCT00874042|Drug|Treatment with ARQ 197 in combination with gemcitabine|"Enrollment of an initial cohort of 3 or 6 patients will follow the traditional 3 + 3 dose escalation scheme. These patients will be treated with ARQ 197 and gemcitabine. ARQ 197 will be administered by mouth BID continuously. Gemcitabine will be administered by intravenous infusion over 30 minutes once weekly for 3 consecutive weeks followed by a week of rest."
16268727|NCT00874029|Device|Halt Procedure|The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.
16268728|NCT00874016|Device|Airtraq|Intubation using Airtraq
16268729|NCT00874016|Device|Direct Laryngoscopy|Intubation using direct laryngoscopy
16268730|NCT00874003|Drug|mirtazapine|oral tablet, 30 mg daily
16268731|NCT00874003|Drug|placebo|oral tablet, 1 daily
16268732|NCT00873990|Other|Total etch bonding agent (5th generation)|"Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch and rinse bonding system (two step bonding agent) will be treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved.
~Adper Single Bond 2 (3M ESPE) will be applied to occlusal fissure using applicator brushes followed by curing for 10 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds."
16268733|NCT00873990|Other|Self etch (7th generation ) bonding agent|For teeth selected for application of self etching bonding agent (Adper Easy Bond 3 M), the bonding agent will be applied to occlusal surface with microbrushes and will be left undisturbed for 20 seconds followed by air drying for 5 seconds and then will be light cured for 10 seconds. Fissure sealant (Clinpro 3M ESPE) will be applied in a similar manner as for etch and rinse group and light cured.
16268734|NCT00873977|Device|CPAP (REMstar (Respironics))|Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.
16268735|NCT00873951|Other|Intestinal and metabolic exploration|Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein. Intestinal, blood and urine are collected at regular intervals.
16268736|NCT00873951|Dietary Supplement|15N-labelled intact casein|standard mixed meal containing 15% of energy as 15N-labelled intact casein
16268737|NCT00873951|Dietary Supplement|15N-labelled hydrolyzed casein|standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein
16268738|NCT00873951|Dietary Supplement|mixture of AA|standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine
16268739|NCT00873925|Biological|Autologous UCB|Umbilical Cord Blood stem cells CAN be collected and frozen immediately after birth in private and public cord blood banks. If a child with recent onset T1D has their OWN cord blood in storage they may qualify for this study. The cells would be released to the University of Florida where we would perform a single IV infusion of the cells once they have been thawed and washed. Depending on how the cells are stored, it may be possible to keep some portion of the cells in storage for future use.
16268740|NCT00873925|Dietary Supplement|Omega 3 FA|Omega 3 Fatty Acids commonly found in fish oil may play an important role in preserving beta cell function via their anti-inflammatory actions. Those subjects randomized to treatment will take a daily supplement supplied as a capsule that can either be swallowed whole or opened so the contents can be mixed with food.
16268741|NCT00873925|Dietary Supplement|Vitamin D|Vitamin D is important for calcium absorption and bone health but may also play an important role in promoting healthy immune responses. Subjects randomized to intervention will take vitamin D supplied as a liquid in a dropper (1 drop per day added to food) for 1 year.
16268742|NCT00873912|Biological|Monovalent influenza virus vaccine|Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).
16268743|NCT00873912|Biological|Placebo|Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.
16268744|NCT00873899|Device|The Medtronic CareLink system (Minneapolis, MN, USA).|The Medtronic CareLink system(Minneapolis, MN, USA)includes a patient monitor plugged into a standard analog telephone connection, and a lightweight wand to communicate with the implanted device. Interrogation of the device and transmission of the data occur when the patient places the wand over the implanted device. The system uses radio frequency telemetry for wireless automatic communication. This allows for data transmission without patient intervention and enables automatic transmissions at pre-specified routine intervals as well as alert-based downloads.The system can transmit data in case of programmable conditions on diagnostic variables, arrhythmias, delivered ICD therapies, battery/lead issues, and alert the physician via phone or e-mail. The patient's information is sent to a secure Network server via the telephone connection and clinical staff can review device information.Available data are equivalent to that which can be retrieved at an in-office visit.
16268745|NCT00873886|Drug|Oseltamivir (Tamiflu)|"The following procedures will be performed on two occasions: once at least three days prior to the scheduled pregnancy termination procedure and again about eight weeks after the termination procedure.
~A) Subject will take 75 mg of oseltamivir pill by mouth
~B) Multiple blood draws (1 teaspoon each) over the next 48 hours after taking oseltamivir. Urine samples also will be collected."
16268746|NCT00873886|Procedure|Blood Draws|Two blood draws (1 teaspoon each) will be performed: once during third trimester of pregnancy and again about eight weeks after delivery.
16268747|NCT00873860|Other|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
16268748|NCT00873860|Biological|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
16268749|NCT00873860|Biological|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
16268750|NCT00873860|Biological|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
16268751|NCT00873834|Drug|fluoxetine|"Treatment with fluoxetine in an oral solution will be given at 0.25mg/kg day during 2 weeks and at 0.4mg/kg day during 16 weeks.
~A progressive decreased of dosage on a period of 4 weeks to 0.25mg/kg/day (2 weeks) and 0.10mg/kg/day(2 weeks) will be realized"
16268752|NCT00873834|Drug|placebo|Placebo comparator. The packaging of study drug and placebo will be performed according to applicable regulatory requirements in the same packaging. An oral solution will be administrated.
16268753|NCT00873821|Drug|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
16268754|NCT00873821|Drug|Comparator: Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
16268755|NCT00873808|Drug|clodronate disodium|
16268756|NCT00873808|Drug|demeclocycline hydrochloride|
16268757|NCT00873808|Drug|ibandronate sodium|
16268758|NCT00873808|Drug|tetracycline hydrochloride|
16268759|NCT00873808|Drug|zoledronic acid|
16268760|NCT00873808|Other|laboratory biomarker analysis|
16268761|NCT00873808|Procedure|adjuvant therapy|
16268762|NCT00873808|Procedure|computed tomography|
16268763|NCT00873808|Procedure|dual x-ray absorptiometry|
16268764|NCT00873795|Drug|aripiprazole , sertraline|In this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo.
16268765|NCT00873782|Other|Retrograde high pressure transvenous perfusion with normal saline|Dose escalation of saline volume, infusion rate, and tourniquet pressure, as determined in a stepwise manner and by careful monitoring
16268766|NCT00873769|Drug|Inhaled Loxapine 10 mg|Staccato Loxapine 10 mg, single dose
16268767|NCT00873756|Drug|FOLFOX regimen|Intravenous repeating dose
16268768|NCT00873756|Drug|bevacizumab|Intravenous repeating dose
16268769|NCT00873756|Drug|dulanermin|Intravenous repeating dose
16268770|NCT00873730|Drug|etanercept|Etanercept 50 mg twice a week (BIW) for 12 weeks
16268771|NCT00873730|Drug|etanercept/placebo|Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
16268772|NCT00873717|Other|Dentary|cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
16268773|NCT00873717|Other|Nutrition|control of the administration of dietary prescriptions, incitement to eat.
16268774|NCT00873717|Other|Dentary + Nutrition|"trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.
~associated with control of the administration of dietary prescriptions, incitement to eat."
16268775|NCT00873704|Other|supplemental postoperative oxygen|
16268776|NCT00873691|Device|ICD|Intervention isn an ICD. Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.
16268777|NCT00873678|Biological|Whole blood sample|Whole blood sample (10 ml)
16268778|NCT00873665|Other|aerobic exercise|To determine the effects of supervised aerobic exercise training versus usual care on incidence of ED among men undergoing radical prostatectomy for clinically localized prostate cancer.
16268779|NCT00873665|Other|wait-list control|To determine the effects of aerobic exercise training versus wait-list control on changes in patient symptoms (i.e., erectile function score, sexual functioning, urinary incontinence, and QOL) and the number of men receiving phosphodiesterases type-5 (PDE-5) inhibitor therapy as well as therapy dose.
16268780|NCT00873652|Biological|Engerix B®, a recombinant hepatitis B vaccine|Single 0.5 ml dose intramuscularly into the deltoid muscle
16268781|NCT00873639|Drug|insulin aspart|Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
16268782|NCT00873639|Drug|insulin detemir|Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
16268783|NCT00873626|Drug|levofloxacin, ciprofloxacin and ofloxacin (fluoroquinolones)|Levofloxacin 500mg : 1/j Ofloxacin : 200mgX2/j Ciprofloxacin 500mg X2/j
16268784|NCT00873613|Procedure|Use of Non-dilated retinal photography|Kowa Non-Myd alpha-D Non-dilated fundus camera will be used to obtain photographs.
16268785|NCT00873600|Drug|chemotherapy|
16268786|NCT00873600|Other|medical chart review|
16268787|NCT00873600|Other|questionnaire administration|
16268788|NCT00873600|Procedure|adjuvant therapy|
16268789|NCT00873600|Procedure|assessment of therapy complications|
16268790|NCT00873600|Procedure|cognitive assessment|
16268791|NCT00873600|Procedure|psychosocial assessment and care|
16268792|NCT00873600|Procedure|quality-of-life assessment|
16268793|NCT00873587|Procedure|Chest tube pull on inspiration|Pull chest tube on Inspiration
16268794|NCT00873587|Procedure|Expiration|Pull chest tube on Expiration
16268795|NCT00873574|Biological|Blood samples and buccal swabs|Peripheral blood samples (35 ml) and buccal swabs
16268796|NCT00873561|Drug|NBI-6024|0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled.
16268797|NCT00873548|Device|PFNA-Asia|"The operation is performed under regional or general anesthesia and involves the following main steps:
~Positioning of the patient
~Definition of the CCD-angle
~Fracture reduction
~Determination of the nail diameter
~Incision
~Insertion of the device"
16268798|NCT00873535|Drug|Varenicline|This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).
16268799|NCT00873535|Drug|Placebo|This group (n=40) will receive matching placebo capsules in the identical dosing regimen described for the Varenicline arm. The group will consist of heavy smokers who are heavy drinkers (n=20) and heavy smokers who are social drinkers (n=20).
16268800|NCT00873509|Drug|Buspirone|Buspirone liquid, 2.5 mg in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study
16268801|NCT00873509|Drug|Buspirone|Buspirone liquid, 5.0 mg in 1 ml , once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study
16268802|NCT00873509|Drug|Placebo|Placebo liquid, in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study
16268803|NCT00873496|Drug|Hydroxychloroquine|
16268804|NCT00873483|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles
16268805|NCT00873470|Procedure|esophagal stimulation|ECG (rest) esophagal stimulation (rest and during effort)
16268806|NCT00873457|Drug|perifosine|Perifosine 50 mg will be taken orally twice a day for a maximum of six 28-day cycles
16268807|NCT00873444|Device|Pinnacle™ Acetabular System|A cementless acetabular cup with ceramic liner for use in total hip replacement
16268808|NCT00873444|Device|Pinnacle™ Acetabular System|A cementless acetabular cup with metal liner for use in total hip replacement
16268809|NCT00873431|Biological|IC47|solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
16268810|NCT00873418|Behavioral|Coping skills training|16 weekly telephone session using to teach heart failure patients self-management skills and how to cope more effectively with psychological distress associated with heart failure.
16268811|NCT00873405|Procedure|Silastic® ring sleeve gastrectomy|SRSG group: ligation of the vessels of the greater curvature of the body and fundus of stomach; resection of the fundus and part of the body of stomach using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the remaining stomach; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
16268812|NCT00873405|Procedure|Silastic® ring gastric bypass|SRGB group: creation of a small, proximal gastric pouch using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the gastric pouch; creation of an intestinal loop of 150 cm and a biliopancreatic loop of 40 cm; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
16268813|NCT00873392|Drug|Transdermal nicotine|Steps of 5 mg until 20 mg Then steps of 10 mg until the dose of 90mg or the maximal tolerated dose One stable dose phase, (90 mg or maximal tolerated dose) during 28 weeks
16268814|NCT00873392|Other|Usual drug treatment of Parkinson's disease|Usual drug treatment of Parkinson's disease
16268815|NCT00873379|Dietary Supplement|melatonin|one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada
16268816|NCT00873379|Dietary Supplement|placebo|half a white placebo tablet
16268817|NCT00873366|Drug|dextromethorphan hydrobromide|
16268818|NCT00873366|Drug|tamoxifen citrate|
16268819|NCT00873366|Other|high performance liquid chromatography|
16268820|NCT00873366|Other|laboratory biomarker analysis|
16268821|NCT00873366|Other|pharmacogenomic studies|
16268822|NCT00873366|Other|pharmacological study|
16268823|NCT00873366|Procedure|fluorescence imaging|
16268824|NCT00873353|Drug|capecitabine + erlotinib|"6 cycles (3 weeks each one) of :
~capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks
~erlotinib (Tarceva®) 150mg/day, oral. Days: every days"
16268825|NCT00873340|Drug|Interferon-1beta (Betaseron, BAY86-5046)|Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be observed.
16268826|NCT00873327|Drug|piperacillin-tazobactam|"6 doses intravenously at the following doses:
~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6
~≥ 14 days PNA 100 mg/kg Q6"
16268827|NCT00873314|Behavioral|Bed rest|The woman assigned to the bed rest group, will be instructed to keep in bed for the study period of four days and will be allowed to go to the toilet
16268828|NCT00873314|Behavioral|Activity restriction|Women assigned to activity restriction group will do the restriction of activities during four days.During the activity restriction phase the women will be allowed to ambulate at home, work at home (home office), child care, household tasks, meal preparation or any forceless activities.
16268829|NCT00873301|Procedure|vestibulectomy|Evaluation of the outcome of vestibulectomy which is the treatment of vulvar vestibulitis
16268830|NCT00873288|Other|informational intervention|
16268831|NCT00873288|Other|questionnaire administration|
16268832|NCT00873275|Biological|bevacizumab|5mg/kg IV day 1 and 15 of each 28 day course of treatment
16268833|NCT00873275|Drug|FOLFOX regimen|Leucovorin, 5-FU and Oxaliplatin
16268834|NCT00873275|Drug|fluorouracil|400 mg/m2 IV bolus immediately following leucovorin on days 1 and 15 of a 28 day course of treatment. Then 2.4 gm/m2 IV continuous infusion over 46 hours immediately following bolus dose on days 1 and 2 and 15 and 16 of a 28 day course of treatment
16268835|NCT00873275|Drug|leucovorin calcium|400 mg/m2 IV infusion over 2 hours on days 1 and 15 of a 28 day course of treatment.
16268836|NCT00873275|Drug|oxaliplatin|85 mg/m2 IV infusion over 2 hours on days 1 and 15 of a 28 day course of treatment.
16268837|NCT00873275|Drug|ursodiol|Dose escalation in cohorts (3 patients/cohort) from an initial dose of 125 mg PO BID through 625 mgs PO BID beginning on Day -6 from infusion of bevacizumab and FOLFOX continuing for the duration of the treatment.
16268838|NCT00873275|Genetic|RNA analysis|Analysis on discard tissues
16268839|NCT00873275|Genetic|gene expression analysis|Determined in normal and malignant tissues in patients who undergo surgical resection after treatment on this trial
16268840|NCT00873275|Genetic|polymerase chain reaction|Analysis on discard tissues
16268841|NCT00873275|Genetic|western blotting|Determined on blood collected at Day -6, Day 0 and Day 7 (1 week after the first cycle of chemotherapy) from treatment and at the end of treatment
16268842|NCT00873275|Other|immunohistochemistry staining method|Performed on tumor blocks from the primary and the metastases from the patients on study
16268843|NCT00873275|Other|laboratory biomarker analysis|Performed on blood collected at Day -6, Day 0 and Day 7 (1 week after the first cycle of chemotherapy) from treatment and at the end of treatment
16268844|NCT00873275|Other|pharmacological study|Day 0, day 7 before treatment, 1/2 hour after the start of treatment, 1, 2, 3, 4, and 8 hours after the start of treatment.
16268845|NCT00873275|Procedure|positron emission tomography (PET)|Patients will undergo PET scan imaging as part of their original staging or at baseline. If the PET scan was more than 2 weeks prior to Day 0 from study treatment, there will be a PET scan at Day 0. In any case there will be a PET scan when the patient completes treatment.
16268846|NCT00873262|Drug|Skin test panel and desensitization kit|"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
~Hormones:
~Progesterone 1mmol/L; Estradiol 1mmol/L; Estrone 3mmol/L; Estriol 3mmol/L
~Controls:
~Saline (NaCl) 0.9%; Ethyl Oleate with 10% Benzyl Alcohol; Histamine phosphate 1mg/ml (epicutaneous- prick test)
~Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the appropriate hormone at the same concentration as it was used in the skin test as follows:
~Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
~Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
~Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml"
16268847|NCT00873262|Drug|Skin test panel and solvent|"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
~Hormones:
~Progesterone 1mmol/L; Estradiol 1mmol/L; Estrone 3mmol/L; Estriol 3mmol/L
~Controls:
~Saline (NaCl) 0.9%; Ethyl Oleate with 10% Benzyl Alcohol; Histamine phosphate 1mg/ml (epicutaneous- prick test)
~Patients with positive skin test to at least one sex hormone will be injected with an increasing volume of the solvent as follows:
~Week 4th of the study (luteal phase of 2nd menstrual cycle) - 0.04 ml
~Week 8th of the study (luteal phase of 3rd menstrual cycle) - 0.08 ml
~Week 12th of the study (luteal phase of 4th menstrual cycle) - 0.16 ml"
16268848|NCT00873236|Biological|bevacizumab|Given IV
16268849|NCT00873236|Biological|recombinant interferon alpha-2a|Given SC
16268850|NCT00873223|Drug|liraglutide|Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration
16268851|NCT00873223|Drug|insulin detemir|Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration
16269367|NCT00869622|Drug|Risedronate|35 mgs/week + calcium and vit d
16268852|NCT00873210|Drug|Sutent|50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
16268853|NCT00873197|Drug|granisetron|"Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours).
~Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only."
16268854|NCT00873184|Behavioral|Massage Therapy|The setting for massage intervention will take place at The Duke Center for Living (DCL). . The massage therapists at the DCL work closely with physicians to design appropriate interventions for patients who are receiving treatment at DUMC, including cancer patients. All DCL therapists have completed more than 600 hours of training, are nationally certified and hold a North Carolina license to practice massage. These types include Swedish, deep muscle, myofascial release, trigger point, acupressure, Bowen Technique, sports massage and chair massage.
16268855|NCT00873158|Device|Dynasplint|"Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen"
16268856|NCT00873145|Procedure|HMRS|Modular prosthetic replacement of the humerus and elbow.
16268857|NCT00873119|Drug|belinostat, carboplatin, paclitaxel|
16268858|NCT00873119|Drug|carboplatin, paclitaxel|
16268859|NCT00873106|Device|Optical coherence tomography|Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT
16268860|NCT00873093|Drug|L-asparaginase|Given IM 6000 IU/m2/dose Days 2 and 9
16268861|NCT00873093|Drug|doxorubicin hydrochloride|Given IV 60 mg/m2/dose on Day 1
16268862|NCT00873093|Drug|therapeutic hydrocortisone|Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
16268863|NCT00873093|Drug|vincristine sulfate|Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
16268864|NCT00873093|Drug|cytarabine|Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
16268865|NCT00873093|Drug|prednisone|Given PO or IV 40 mg/m2/day on Days 1-28
16268866|NCT00873093|Drug|bortezomib|Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
16268867|NCT00873093|Drug|pegaspargase|Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
16268868|NCT00873093|Drug|methotrexate|Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
16268869|NCT00873093|Drug|etoposide phosphate|Given IV 100 mg/m2/dose on Days 1-5
16268870|NCT00873093|Drug|cyclophosphamide|Given IV 440 mg/m2/dose on Days 1-5
16268871|NCT00873093|Biological|filgrastim|Given IV or SC 5 micrograms/kg/dose Only on Day 6
16268872|NCT00873093|Drug|leucovorin calcium|Given PO or IV 15mg/m2/dose q6h x 3 doses
16268873|NCT00873093|Other|laboratory biomarker analysis|Correlative studies
16268874|NCT00873093|Drug|High Dose MTX|IV 5000 mg/m2/dose Block 2: Day 22
16268875|NCT00873067|Procedure|Additional Complex Fractionated Electrograms ablation|Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
16268876|NCT00873067|Procedure|Standard atrial fibrillation ablation procedure|Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.
16268877|NCT00873041|Drug|deferasirox|Supplied as 125 mg, 250 mg and 500 mg tablets.
16268878|NCT00873041|Drug|placebo|Supplied as matching 125 mg, 250 mg and 500 mg tablets.
16268879|NCT00873028|Other|In Hospital Cardiopulmonary Rehabilitation|The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs
16268880|NCT00873015|Drug|Sodium nitrite|14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
16268881|NCT00873015|Drug|Saline|14 day continuous infusion of a vehicle control infusion
16268882|NCT00873002|Drug|panobinostat|Dose escalation: 7.5 mg/m2 day 1 and day 8 of 21 days cycle 10 mg/m2 day 1 and day 8 of 21 days cycle 15 mg/m2 day 1 and day 8 of 21 days cycle 20 mg/m2 day 1 and day 8 of 21 days cycle 30 mg/m2 day 1 and day 8 of 21 days cycle
16268883|NCT00873002|Drug|sorafenib tosylate|400 mg PO BID
16268884|NCT00872989|Drug|docetaxel|Given IV
16268885|NCT00872989|Drug|vandetanib|Given orally
16268886|NCT00872976|Drug|Dasatinib|One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
16268887|NCT00872976|Drug|Combination of Bendamustine + Dasatinib|"Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles
~Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles"
16268888|NCT00872976|Drug|Dasatinib|One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
16268889|NCT00872976|Drug|Combination of Bendamustine + Dasatinib|"Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles
~Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles"
16268890|NCT00872963|Biological|RTS,S/AS01E|0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule
16268891|NCT00872950|Drug|3,4-DIAMINOPYRIDINE|Treatment will begin with a low dose and will be increased as clinically needed as tolerated. The upper limit will be a total of 100mg/day.
16268892|NCT00872924|Drug|sumatriptan 100mg|
16268893|NCT00872911|Dietary Supplement|Amino acids|mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
16268894|NCT00872911|Drug|Exercise|progressive exercise training
16268895|NCT00872898|Drug|Memantine - Extended Release (ER)|Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
16268896|NCT00872898|Drug|Placebo|Placebo capsules, once daily, oral administration.
16268897|NCT00872885|Drug|GRT6005|liquid formulation, 200 to 600 µg, single dose, one day
16268898|NCT00872885|Drug|Morphine|60 mg
16268899|NCT00872885|Drug|Placebo|single dosage
16268900|NCT00872872|Drug|AZT/3TC 2 weeks after delivery|AZT/3TC 300/150mg will be given every 12 hours for 1 week after NVP discontinuation in arm 1 and for 2 weeks after NVP discontinuation in arm 2.
16268901|NCT00872859|Procedure|Implantation of Dermal Matrix substitute|Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
16268902|NCT00872846|Device|BALANCE System intestinal electrical stimulator|The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural contractions and mimic the sensation of fullness (satiety). The patient is expected to feel full after eating smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels.
16268903|NCT00872820|Behavioral|Acceptance- and commitment-based behavioral therapy|12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings
16268904|NCT00872820|Behavioral|Cognitive behavioral therapy|12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies
16268905|NCT00872807|Behavioral|Lifestyle counseling in groups|"The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality.
~They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months."
16268906|NCT00872807|Behavioral|Individual intervention|Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
16268907|NCT00872794|Device|DePuy ASR™ Hip System|A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty.
16268908|NCT00872781|Drug|fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets|
16268909|NCT00872755|Procedure|Nissen|Laparoscopic Nissen Fundoplication
16268910|NCT00872755|Procedure|Gastropexy|posterior gastropexy
16268911|NCT00872742|Behavioral|Acceptance enhanced behavior therapy (AEBT)|Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
16268912|NCT00872742|Behavioral|Psychoeducation and supportive therapy (PST)|Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it
16268913|NCT00872729|Drug|Cystagon®|"Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
~Duration of Treatment and Dose: Reference Period up to four doses Q6H."
16268914|NCT00872729|Drug|RP103|"Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
~Duration of treatment and Dose: Single dose of Test Product at dose equivalent to Reference Product."
16268915|NCT00872716|Drug|Quetiapine XR|100 mg single-dose Quetiapine XR
16268916|NCT00872716|Other|Placebo|Placebo
16268917|NCT00872677|Behavioral|Diet|Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.
16268918|NCT00872677|Other|Spiritual counseling|Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.
16268919|NCT00872664|Dietary Supplement|carotenoids|beta-carotene, lycopene, lutein
16268920|NCT00872651|Drug|Travoprost 0.004%/Timolol 0.5%|Travoprost 0.004%/Timolol 0.5%
16268921|NCT00872651|Drug|Latanoprost 0.005% / Timolol 0.5%|Latanoprost 0.005% / Timolol 0.5%
16268922|NCT00872638|Procedure|Eversion|Surgical incisions will be closed in such a manner so as to evert the wound edges.
16268923|NCT00872638|Procedure|Approximation|Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.
16268924|NCT00872625|Drug|cyclophosphamide|
16268925|NCT00872625|Drug|docetaxel|
16268926|NCT00872625|Drug|epirubicin hydrochloride|
16268927|NCT00872625|Drug|fluorouracil|
16268928|NCT00872625|Procedure|neoadjuvant therapy|
16268929|NCT00872625|Procedure|therapeutic conventional surgery|
16268930|NCT00872625|Radiation|hypofractionated radiation therapy|
16268931|NCT00872625|Radiation|image-guided radiation therapy|
16268932|NCT00872625|Radiation|radiation therapy|
16268933|NCT00872625|Radiation|stereotactic radiosurgery|
16268934|NCT00872612|Procedure|EUS-FNA/EBUS-TBNA + BAL|"EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes.
~EBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes.
~BAL = bronchoalveolar lavage"
16268935|NCT00872612|Procedure|EBB + TBLB + BAL|EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage
16268936|NCT00872599|Drug|fenofibrate|Subjects will be randomized to receive either fenofibrate 160 mg/day or matching placebo for five days by mouth.
16268937|NCT00872599|Drug|Placebo|Subjects will be randomized to receive placebo or fenofibrate for five days by mouth
16268938|NCT00872586|Drug|olmesartan medoxomil + hydrochlorothiazide|olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks
16268939|NCT00872586|Drug|olmesartan medoxomil|olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks
16268940|NCT00872573|Device|C-Stem™ AMT Femoral Component (standard and high off-set variants)|A polished triple tapered cemented femoral component for use in total hip replacement
16268941|NCT00872560|Device|NovoFine® needle 6 mm|
16268942|NCT00872560|Device|NovoFine® needle 8 mm|
16268943|NCT00872547|Device|DePuy ASR™ Hip System|Resurfacing system
16268944|NCT00872547|Device|DePuy ASR™ XL Head / ASR™ Acetabular Cup System|Large Metal-on-Metal Total Hip Replacement
16268945|NCT00872534|Drug|acetylsalicylic acid|325mg once a day for 7 days
16270192|NCT00863889|Drug|Lidocaine, Marcaine|4 cc of each local anesthetic
16268946|NCT00872521|Drug|PAD induction|"Open Label Treatment:
~Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 & 11), Doxorubicin 20 mg/m2 i.v. (D1 & 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 & 12)"
16268947|NCT00872482|Drug|nimotuzumab|Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.
16268948|NCT00872469|Drug|Tranexamic acid|1-2 grams by intravenous injection
16268949|NCT00872469|Drug|Placebo [Saline]|Matched to active comparator
16268950|NCT00872443|Other|Data collection|"Collection of characteristics of interauricular septum, characteristics of the CVA, and headache history.
~Collection of anamnesis data, surgical past history, especially at the moment of the implement of prothesis, collection of dtat of transthoracic echography, transcranial echodoppler, holter ECG, cerebral MRI."
16268951|NCT00872430|Other|Placebo|In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.
16268952|NCT00872430|Other|Klein Laxative Tea|The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.
16268953|NCT00872417|Drug|first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)|use the generic regimens: 3TC+NVP+D4T or 3TC+NVP+AZT to initiate the ARV therapy, after 6 months, half of the group 3TC+NVP+D4T patients switch to the the treatment of 3TC+NVP+AZT
16268954|NCT00872417|Drug|second line ARV therapy (3TC+TDF+LPV/RTV)|Use 3TC+TDF+LPV/RTV to treat those drug resistance patients, to explore the efficiency and safety of the second line ARV available in China
16268955|NCT00872404|Drug|CP-751,871|20mg/kg/3 weeks
16268956|NCT00872391|Radiation|Hypofractionated linear accelerator radiotherapy|10 fractions of stereotactic linear accelerator radiotherapy with 6 Gy per fraction at the 80% isodose for the planning target volume.
16268957|NCT00872378|Drug|Exenatide|Exenatide titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID).
16268958|NCT00872378|Drug|Placebo|Placebo titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID).
16268959|NCT00872365|Behavioral|Regular aerobic physical exercise|Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
16268960|NCT00872365|Dietary Supplement|Micronutrients|Zinc 30mg, Magnesium 400mg, Beta-carotene 9 mg, Tocopherol 30mg, vitamin C 200mg y Niacin 100mg.
16268961|NCT00872365|Other|Activities of daily living + placebo|"Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist and prenatal care.
~Placebo Comparator: Equivalent to placebo (maltodextrin)."
16268962|NCT00872352|Procedure|EMG|Nerve conduction study will be consisted of sequential evaluation of the motor nerves: median, ulnar, peroneal and tibial; and the sensory nerves: median, ulnar, superficial peroneal and sural nerves using a standardized protocol
16268963|NCT00872326|Procedure|Autologous Bone Marrow Mononuclear Cells|Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
16268964|NCT00872300|Drug|PHA-739358|Weekly IV infusion for 3 consecutive weeks in a 4-week cycle
16268965|NCT00872287|Procedure|Laparoscopic Cholecystectomy|Four ports classic laparoscopic cholecystectomy
16268966|NCT00872287|Procedure|SILS|Single transumbilical incision laparoscopic cholecystectomy
16268967|NCT00872274|Drug|sumatriptan 100mg|
16268968|NCT00872248|Procedure|Spinal anesthesia|Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
16268969|NCT00872248|Procedure|Epidural anesthesia|Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
16268970|NCT00872235|Drug|fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets|
16268971|NCT00872222|Device|Pinnacle™ Acetabular System|A cementless acetabular cup with ceramic liner for use in total hip replacement
16268972|NCT00872209|Drug|0.3% Ciprofloxacin Ear Drops|4 gtt BID for 7 days.
16268973|NCT00872209|Drug|0.3% Ciprofloxacin Foam Otic Cipro|1 application, BID for 7 days
16268974|NCT00872196|Drug|ABT-072|Blood samples are being taken from subjects previously treated with ABT-072.
16268975|NCT00872170|Drug|Sildenafil|"Participants will receive sildenafil for 12 weeks with the following therapy:
~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
16268976|NCT00872157|Drug|BMTP-11|Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.
16268977|NCT00872144|Drug|Sativex|Sativex (or placebo) will be dispensed identical 5.5 ml containers. Participants will be instructed to start with a dose of 1 spray trans-mucosally at 1800 hrs. If there are no limiting adverse effects such as sedation or dizziness, participants will be instructed to increase the dose to 2 sprays- one in the morning and the other in the early evening on day two. Participants may increase the dose by 1-2 sprays per day to a maximum dose of 12 sprays per day given 3 sprays 4 times per day. In the initial titration phase participants will be instructed to space each dose actuation 15 minutes apart until accustomed to the preparation. Participants will titrate the dose to a level where they obtain an analgesic effect without limiting side effects.
16268978|NCT00872131|Drug|Sertraline|Oral sertraline will begin at 50 mg per day, then increase to 75 mg per day on Day 8, then increase to 100 mg per day on Day 15. The dose may be increased to 150 mg per day on Week 8, based on clinical response and medication toleration.
16268979|NCT00872118|Behavioral|Brief Intervention for Socially Anxious Drinkers (BISAD)|integrated alcohol and social anxiety individual intervention
16268980|NCT00872118|Behavioral|Enhanced Alcohol Skills Building and Education Program|alcohol-focused group intervention
16268981|NCT00872105|Procedure|Non-operative Treatment|Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
16269024|NCT00871923|Radiation|Radiation Therapy|Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
16268982|NCT00872105|Procedure|Operative Treatment|"The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:
~Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)"
16268983|NCT00872092|Other|Stable-isotope labeled lactose ureide breath test|2 g 13C-labeled lactose ureide orally
16268984|NCT00872079|Device|Genomics|Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an international normalized ratio (INR) value within a specific target range.
16268985|NCT00872066|Device|SmartSet® HV bone cement|A high viscosity bone cement for use in total hip replacement (without gentamicin)
16268986|NCT00872066|Device|SmartSet® GHV bone cement|A high viscosity bone cement for use in total hip replacement (with gentamicin)
16268987|NCT00872053|Device|Anklebot|"The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training games, the Anklebot can assist ankle movement throughout 3 planes."
16268988|NCT00872053|Device|Lokomat|The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.
16268989|NCT00872040|Other|Ultrasound assessment of pelvic floor|Sample of women will undergo ultrasound examination of their pelvic floor before and after delivery. The assessment will be performed by transperineal probe.
16268990|NCT00872027|Drug|Escitalopram|10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents
16268991|NCT00872027|Drug|Placebo|Placebo pills for 8 weeks
16268992|NCT00872014|Drug|AMG 386|Two doses of AMG 386 (15 mg/kg) IV QW will be studied
16268993|NCT00872014|Drug|AMG 386|Two doses of AMG 386 (10 mg/kg) IV QW will be studied
16268994|NCT00872014|Drug|Sorafenib|Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort
16268995|NCT00872001|Drug|Acadesine|Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardioplegia solution of acadesine will be administered, and acadesine will be added to the priming solution (5 µg/mL) in the heart lung machine during CPB.
16268996|NCT00872001|Drug|Normal Saline|Normal saline, 500 mL delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 1.2 mL/min for a 500 mL solution. In addition, standard cardioplegia solution with added normal saline will be administered, and placebo (normal saline) will also be added to the heart lung machine priming solution.
16268997|NCT00871975|Device|Urodynamics + TETRA - NIRS|Urodynamics will be performed as per standard of care for patients enrolled, whereby one catheter is inserted into the bladder and one in the rectum to analyze bladder filling, storage and voiding conditions via pressures measured and urine flow rates detected by a uroflowmeter. Tetra-NIRS will be concurrently performed where Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome. A patch is applied externally to measure these changes in the detrusor muscle of the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified a correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures.
16268998|NCT00871962|Other|OXYGEN SUPPLEMENTATION|Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%
16268999|NCT00871949|Drug|PNU-100480|100 mg oral suspension given once
16269000|NCT00871949|Drug|PNU-100480|300 mg oral suspension given once
16269001|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269002|NCT00871949|Drug|PNU-100480|300 mg oral suspension given once
16269003|NCT00871949|Drug|PNU-100480|35 mg oral suspension given once
16269004|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269005|NCT00871949|Drug|PNU-100480|100 mg oral suspension given once
16269006|NCT00871949|Drug|PNU-100480|35 mg oral suspension given once
16269007|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269008|NCT00871949|Drug|PNU-100480|1000 mg oral suspension given once
16269009|NCT00871949|Drug|PNU-100480|1500 mg oral suspension given once
16269010|NCT00871949|Drug|PNU-100480|Fed conditions, 600 mg oral suspension given once
16269011|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269012|NCT00871949|Drug|PNU-100480|1500 mg oral suspension given once
16269013|NCT00871949|Drug|PNU-100480|600 mg oral suspension given once
16269014|NCT00871949|Drug|PNU-100480|Fed conditions, 600 mg oral suspension given once
16269015|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269016|NCT00871949|Drug|PNU-100480|1000 mg oral suspension given once
16269017|NCT00871949|Drug|PNU-100480|600 mg oral suspension given once
16269018|NCT00871949|Drug|PNU-100480|Fed conditions, 600 mg oral suspension given once
16269019|NCT00871949|Drug|Placebo|placebo to match oral suspension given once
16269020|NCT00871936|Drug|SLx-4090|SLx-4090
16269021|NCT00871936|Other|Placebo|matching tablets
16269022|NCT00871936|Drug|Metformin|
16269023|NCT00871923|Drug|Tarceva (Erlotinib hydrochloride)|150 mg by mouth every day beginning Day 1.
16269025|NCT00871910|Drug|SCH 727965|SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
16269026|NCT00871910|Drug|SCH 727965|SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts
16269027|NCT00871910|Drug|SCH 727965|SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts
16269028|NCT00871910|Drug|SCH 727965|SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
16269029|NCT00871910|Drug|Aprepitant|Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3.
16269030|NCT00871910|Drug|Ondansetron|Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
16269031|NCT00871910|Drug|Dexamethasone|Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4.
16269032|NCT00871884|Behavioral|Psychoeducation|Education about the common prognostic considerations, normal symptoms experienced and etiology of symptoms following mild head injury. Includes some basic suggestions surrounding methods to diminish the impact of symptoms on one's life.
16269033|NCT00871884|Behavioral|Relaxation Training|Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.
16269034|NCT00871884|Behavioral|Interoceptive Exposure|Includes a variety of exercises used to elicit somatic sensations which may be feared by the participant, in an attempt to extinguish or lessen the fear reaction to these sensations.
16269035|NCT00871871|Drug|Hydrochlorothiazide (HCTZ)|HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
16269036|NCT00871871|Drug|Comparator: Placebo to HCTZ|Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
16269037|NCT00871871|Drug|Isosorbide mononitrate (ISMN)|ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
16269038|NCT00871871|Drug|Comparator: Placebo to ISMN|Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
16269039|NCT00871858|Drug|anastrozole|Given orally
16269040|NCT00871858|Drug|fulvestrant|Given intramuscularly
16269041|NCT00871845|Behavioral|Dietary and Lifestyle modification educational sessions|6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy.
16269042|NCT00871819|Device|Precision Spinal Cord Stimulation (SCS)|Various SCS device programming parameters
16269043|NCT00871806|Drug|Commercial tablet with water|40 mg tablet, given once to each subject
16269044|NCT00871806|Drug|ODT #1 without water|40 mg tablet given once to each subject
16269045|NCT00871806|Drug|ODT #2 without water|40 mg tablet given once to each subject
16269046|NCT00871806|Drug|ODT #1 with water|40 mg tablet given once to each subject
16269047|NCT00871806|Drug|ODT #2 with water|40 mg tablet given once to each subject
16269048|NCT00871793|Other|Occupational therapy|Participants in this arm will receive six sessions of occupational therapy in a 5 week period.
16269049|NCT00871780|Drug|BG00002 (natalizumab)|
16269050|NCT00871767|Drug|AZD5672|40 mg tablet (Test formulation)
16269051|NCT00871767|Drug|AZD5672|40 mg tablet (Reference formulation)
16269052|NCT00871767|Drug|AZD5672|100 mg tablet (Test formulation)
16269053|NCT00871767|Drug|AZD5672|100 mg (2 x 50 mg tablet (Reference Formulation)
16269054|NCT00871741|Biological|GSK2202083A vaccine|Intramuscular, three doses
16269055|NCT00871741|Biological|Infanrix hexa|Intramuscular, three doses
16269056|NCT00871741|Biological|Menjugate|Intramuscular, two doses
16269057|NCT00871728|Drug|Itraconazole|Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.
16269058|NCT00871715|Behavioral|Accelerated Skill Acquisition Program (ASAP)|A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.
16269059|NCT00871715|Behavioral|Dose-Equivalent Usual & Customary Care - DEUCC|Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
16269060|NCT00871715|Behavioral|Usual and Customary Care - UCC|Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.
16269061|NCT00871702|Genetic|CD34-TK75 transduced donor lymphocytes|
16269062|NCT00871702|Radiation|Sub Study - 18 FHBG PET/CT Scans|Three 18 FHBG PET/CT Scans will be performed first one at pre-DLI infusion, second 14 days post-DLI infusion and third 30 days post-DLI infusion - patients #3 - #8
16269063|NCT00871689|Biological|aldesleukin|IL-2 will be administered (9 million units; 5 million units if weight is less than 45 kg) every other day beginning on day +3 for a total of 6 doses and again on day +60 every other day for 6 doses.
16269064|NCT00871689|Drug|cyclophosphamide|60 mg/kg over 1 hour intravenously (IV) on days -7 and -6.
16269065|NCT00871689|Drug|fludarabine phosphate|25 mg/m^2 intravenously (IV) over 1 hour on days -7 through -5.
16269066|NCT00871689|Procedure|umbilical cord blood transplantation|On day 0, transplantation will occur with double T-cell depleted (TCD) umbilical cord blood (UCB) units
16269067|NCT00871689|Radiation|total-body irradiation|administered on days -5 through -2; 330 cGy daily
16269068|NCT00871676|Behavioral|Lifestyle modification|16 weekly followed by 8 monthly group behavioral weight loss sessions.
16269069|NCT00871676|Behavioral|Lifestyle modification plus gum|16 weekly followed by 8 monthly group behavioral weight loss sessions. Subjects were also given gum along with instructions for times and occasions to chew with the aim of facilitating weight loss and appetite control.
16269070|NCT00871663|Drug|SCH 727965|Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
16269071|NCT00871650|Other|Sleep data recording|After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
16269072|NCT00871650|Other|PET scan - waking|After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
16269073|NCT00871650|Other|PET scan - REM Sleep|After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
16269074|NCT00871624|Drug|Dexmedetomidine|Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
16269075|NCT00871624|Drug|Placebo|Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
16269076|NCT00871598|Drug|BTT1023|intravenous, three infusions over three weeks
16269077|NCT00871598|Drug|Placebo|intravenous, three infusions over three weeks
16269078|NCT00871598|Drug|BTT1023|Test challenge
16269079|NCT00871572|Drug|LY2409021|4 capsules by mouth taken once daily for 12 weeks
16269080|NCT00871572|Drug|Placebo|4 capsules by mouth once daily for 12 weeks
16269081|NCT00871559|Drug|REGN421(SAR153192)|
16269082|NCT00871546|Drug|SCH 727965|SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.
16269083|NCT00871546|Drug|Bortezomib|Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.
16269084|NCT00871546|Biological|Alemtuzumab|Alemtuzumab dose-titrated to the goal maintenance dose of 30 mg/day IV or SC three times a week on alternate days for a total of 12 weeks.
16269085|NCT00871533|Drug|IFNα2b|IV injection at 20 million IU/m2. IFNα2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions.
16269086|NCT00871533|Drug|IFNα2b|SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections.
16269087|NCT00871533|Drug|PEG- IFNα2b|SC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections.
16269088|NCT00871533|Drug|PEG- IFNα2b|SC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections.
16269089|NCT00871520|Other|no specific interventions|There are no specific interventions in this observational study
16269090|NCT00871507|Drug|JNJ-38431055 Dose 1|Liquid suspension/solution of JNJ-38431055 administered as a single dose
16269091|NCT00871507|Drug|Sitagliptin 100 mg|Capsule containing 100 mg of sitagliptin administered as a single dose.
16269092|NCT00871507|Drug|Placebo|Placebo suspension/solution and Placebo capsule administered as single doses
16269093|NCT00871507|Drug|JNJ-38431055 Dose 2|Liquid suspension/solution of JNJ-38431055 administered as a single dose
16269094|NCT00871494|Drug|Azithromycin|The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.
16269095|NCT00871481|Biological|ipilimumab|Given IV
16269096|NCT00871481|Drug|cyclophosphamide|Given IV
16269097|NCT00871481|Procedure|biopsy|Optional correlative studies
16269098|NCT00871481|Biological|aldesleukin|Given SC
16269099|NCT00871481|Other|immunohistochemistry staining method|Correlative studies
16269100|NCT00871481|Genetic|polymerase chain reaction|Correlative studies
16269101|NCT00871481|Other|immunoenzyme technique|Correlative studies
16269102|NCT00871481|Biological|therapeutic cytotoxic T lymphocytes|Given IV
16269103|NCT00871468|Procedure|superior plate|Open reduction internal fixation (ORIF) clavicle with superior plate
16269104|NCT00871468|Procedure|anterior-inferior plate|ORIF clavicle with anterior inferior plate
16269105|NCT00871455|Drug|Baclofen|Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.
16269106|NCT00871442|Other|No Basal Infusion|Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
16269107|NCT00871442|Other|Basal infusion|Group 2 Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout)
16269108|NCT00871442|Drug|PCEA solution (bupivacaine and fentanyl)|PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml
16269109|NCT00871429|Other|Lindi skin care products|"Subjects will then be instructed to apply all three products daily for 1 month.
~The products include: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B, and Lindi Skin face wash (product C)."
16269110|NCT00871416|Device|NovoFine® needle 6 mm|
16269111|NCT00871416|Device|NovoFine® needle 12 mm|
16269112|NCT00871403|Drug|pazopanib and pemetrexed|oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily
16269113|NCT00871403|Drug|pemetrexed and cisplatin|pemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks
16269114|NCT00871377|Drug|Placebo|corn oil (n-6 fatty acids)
16269115|NCT00871377|Drug|High Dose Fish Oil|n-3 fatty acids, 1060 mg EPA + DHA
16269116|NCT00871377|Drug|Low Dose Fish Oil|n-3 fatty acids, 2160 mg EPA + DHA
16269117|NCT00871364|Drug|VENLAFAXINE TABLETS 50 mg , single dose|A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
16269118|NCT00871364|Drug|Effexor® Tablets equivalent to 50 mg venlafaxine|B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions
16269119|NCT00871351|Drug|Ezetimibe|1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
16269120|NCT00871351|Drug|Atorvastatin|1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
16269121|NCT00871351|Drug|Atorvastatin|2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
16269122|NCT00871351|Drug|Rosuvastatin|1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)
16269123|NCT00871338|Biological|GSK2197870A|3 doses given at 2, 3 and 4 months of age
16269124|NCT00871338|Biological|Prevenar™|3 co-administered doses, intramuscular into right thigh
16269125|NCT00871338|Biological|Menitorix™|1 booster dose at 12 months of age
16269126|NCT00871338|Biological|Pediacel™|3 doses given at 2, 3 and 4 months of age
16269127|NCT00871338|Biological|Menjugate™|2 doses given at 3 and 4 months of age
16269128|NCT00871325|Drug|Daikenchuto (TU-100)|Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
16269129|NCT00871325|Drug|Daikenchuto (TU-100)|Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
16269130|NCT00871325|Drug|Placebo|Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
16269131|NCT00871312|Device|Topical wound oxygen therapy|90 minutes 4 days per week Active Topical Oxygen Therapy
16269132|NCT00871312|Device|Topical wound oxygen Placebo|90 mins per day 4 days per week Placebo Therapy
16269133|NCT00871299|Behavioral|Mindfulness Based Cognitive Therapy|"Mindfulness-Based Cognitive Therapy (MBCT) is a group treatment that integrates mindfulness meditation training with some CBT concepts and was specifically developed as a relapse prevention intervention for MDD. The program teaches skills that allow patients to disengage from habitual (automatic) dysfunctional cognitive routines, in particular depression-related ruminative thought patterns, as a way to reduce future risk of relapse and recurrence of depression."
16269134|NCT00871299|Behavioral|Health Enhancement Program and medication management|The Health Enhancement Program (HEP)was developed at the University of Wisconsin, Madison and is modeled after traditional activity and nutrition programs used in weight management- cardiac rehab and diabetes prevention programs. The program is designed to increase overall health and well-being by focusing on four health domains that impact health and are interventions regularly practiced at integrative medicine. These include: (I) Music Therapy (2) Nutrition (3) physical activity including, walking and stretching and (4) Functional movement.
16269135|NCT00871286|Procedure|Pre-treatment Sinus CT Scan|Pre-treatment Sinus CT Scan
16269136|NCT00871286|Procedure|Post-treatment Sinus CT Scan|Post-treatment Sinus CT Scan
16269137|NCT00871273|Drug|capecitabine|film-coated tablet 1250 mg/m2 twice daily 14 days for 14 days. Number of cycles: 3 cycles pre-operatively and 3 cycles post-operatively unless there is evidence of disease progression on chemotherapy
16269138|NCT00871260|Drug|regadenoson|Subjects in open label group will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus) as contrast.
16269139|NCT00871247|Drug|Finasteride 5 mg Tablet, single dose|A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fed conditions
16269140|NCT00871247|Drug|Proscar® 5 mg Tablet, single dose|B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fed conditions
16269141|NCT00871234|Drug|Etravirine|Two one-hundred mg tablets orally twice daily for four weeks
16269142|NCT00871208|Drug|Altabax (R)|Retapamulin 1% ointment is to be applied to lesional atopic dermatitis twice-daily in addition to a topical corticosteroid (Locoid lipocream (R))
16269143|NCT00871208|Drug|Vehicle and Locoid lipocream (R)|The vehicle base of retapamulin ointment will be applied twice-daily to active lesions of atopic dermatitis in addition to locoid lipocream (R)
16269144|NCT00871182|Drug|Inhaled PT001|single dose, inhaled
16269145|NCT00871182|Drug|Inhaled Placebo|single dose, inhaled
16269146|NCT00871182|Drug|Tiotropium Handihaler|single dose, tiotropium 18 mcg administered via the Handihaler
16269147|NCT00871169|Drug|Irinotecan, oxaliplatin, and cetuximab|"Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).
~The treatment interval (one cycle) is every 14 days."
16269148|NCT00871156|Drug|Chloroquine, Tafenoquine|Chloroquine and Tafenoquine
16269149|NCT00871156|Drug|Placebo|Placebo
16269150|NCT00871143|Behavioral|CBT specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
16269151|NCT00871143|Behavioral|Non specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
16269152|NCT00871130|Procedure|Bariatric surgery|gastric banding, gastric bypass or vertical gastroplasty either open or laparoscopic or a combination of any
16269153|NCT00871117|Biological|GSK Biologicals'Kinrix®|One dose as intramuscular injection at visit 1
16269154|NCT00871117|Biological|Merck and Company's MMRII|One dose as subcutaneous injection at visit 1
16269155|NCT00871117|Biological|Merck and Company's Varivax|One dose as subcutaneous injection at visit 1 or at visit 2
16269156|NCT00871104|Drug|Fosfomycin and imipenem|IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks
16269157|NCT00871104|Drug|Vancomycin|IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
16269158|NCT00871091|Procedure|orthodontic treatment with customized archwires|customized arch wires depending on the amount of needed tooth movement
16269159|NCT00871091|Procedure|orthodontic treatment with prefabricated archwires|prefabricated archwires depending of the needed movement of the teeth
16269160|NCT00871091|Procedure|orthodontic tx w/ conventional archwires+manual adjustments|conventional archwires modified by manual adjustment, depending of needed correction
16269161|NCT00871078|Device|Optical Coherence Tomography (OCT)|Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls
16269162|NCT00871078|Device|Frequency Doubling Technology (FDT) perimeter|24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.
16269163|NCT00871065|Drug|Sildenafil citrate|20 mg tablet orally every 8 hours until Day 14 post-hemorrhage
16269164|NCT00871052|Drug|Calcipotriol-containing cream|Topical treatment twice a day for 7 days
16269165|NCT00871039|Drug|Propofol|Patients to be sedated for up to 72 hours with study drug propofol
16269166|NCT00871039|Drug|Midazolam|Patients to be sedated for up to 72 hours with study drug midazolam
16269167|NCT00871026|Procedure|orthodontic treatment with customized archwires|orthodontic treatment with customized archwires
16269168|NCT00871026|Procedure|orthodontic treatment with prefabricated archwires|orthodontic treatment with prefabricated archwires
16269169|NCT00871013|Drug|Melphalan|"Given by vein, Day 3
~First Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4
~Second Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4
~Second Transplant Bortezomib (Velcade) By vein Day -5 and Day -2
~Year 1 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 28 days
~Years 2 & 3 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 56 days"
16269170|NCT00871013|Drug|Velcade|Given by vein, Days 1, 5, 8, 11
16269171|NCT00871013|Drug|Thalidomide|Given by mouth at bedtime, Days 5-8
16269172|NCT00871013|Drug|Dexamethasone|Given by mouth, once per day Days 5-8
16269173|NCT00871013|Drug|Cisplatin|Given by vein, Days 5-8 continuous infusion
16269174|NCT00871013|Drug|Adriamycin|Given by vein, days 5-8 continuous infusion
16269175|NCT00871013|Drug|Cyclophosphamide|Given by vein days 5-8 continuous infusion
16269176|NCT00871013|Drug|Etoposide|Given by vein days 5-8 continuous infusion
16269177|NCT00871000|Biological|Boostrix Polio™ 711866|Single dose, intramuscular administration.
16269178|NCT00871000|Biological|Priorix Tetra TM 208136|Single dose, subcutaneously.
16269179|NCT00871000|Biological|Tetravac TM|Single dose, intramuscular administration.
16269180|NCT00870987|Biological|DNA vaccine prime|2 mg total dose (1 mg per construct in a volume of 1 mL)
16269181|NCT00870987|Biological|adenovirus type 5 vaccine boost|2 x 1010 particle units (pu) (1 x 1010 pu per each of 2 constructs including CSP and AMA1 respectively)
16269182|NCT00870974|Drug|[18F]FPEB|Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]F-PEB
16269183|NCT00870961|Dietary Supplement|cholecalciferol|Given orally
16269184|NCT00870961|Other|placebo|Given orally
16269185|NCT00870948|Drug|ABT-874|See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
16269186|NCT00870935|Procedure|Balloon catheter|Hysterosalpingography is performed using intrauterine balloon catheter
16269187|NCT00870935|Procedure|Cervical vacuum cup|Hysterosalpingography is performed using cervical vacuum cup
16269188|NCT00870922|Procedure|Active release techniques|Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART
16269189|NCT00870909|Procedure|active tDCS|Intensity 2 mA during 20 minutes, 2 times per day
16269190|NCT00870909|Procedure|sham tDCS|sham condition as delivered by the stimulator
16269191|NCT00870896|Drug|Tiotropium|Each subject will then receive Spiriva 18 ug/day for a total of 4 weeks. Each subject will be instructed by the PI on the proper use of the Spiriva inhaler and demonstrate the ability to properly perform the inhalation technique prior to leaving the laboratory. The patient will receive their first dose in the laboratory under the direct supervision of one of the investigators. In addition, subjects will be requested to take their Spiriva inhalation treatment the same time each day.
16269192|NCT00870883|Drug|N-acetylcysteine and deferoxamine|N-acetylcysteine bolus dose of 50mg/kg/4h, by a manutention of 100mg/kg/day during 2 days and deferoxamine single dose of 1g administered 15mg/kg/h.
16269193|NCT00870870|Drug|Gemcitabine|"1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle
~[First 6 cycles (18 weeks)]"
16269194|NCT00870870|Drug|Cisplatin|"75 mg/m^2 on Day 1 of each cycle
~[First 6 cycles (18 weeks)]"
16269195|NCT00870870|Biological|IMC-A12 (cixutumumab)|"6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)
~[First 6 cycles (18 weeks)]"
16269196|NCT00870870|Biological|Cetuximab|"400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter
~[First 6 cycles (18 weeks)]"
16269197|NCT00870870|Biological|IMC-A12 (cixutumumab)|"10 mg/kg IV infusion, administered once every 2 weeks
~(Maintenance therapy)"
16269198|NCT00870870|Biological|Cetuximab|"500 mg/m^2 IV infusion, administered once every 2 weeks
~(Maintenance therapy)"
16269199|NCT00870870|Drug|Carboplatin|"Area under the curve (AUC) = 5, Day 1 of each cycle
~[First 6 cycles (18 weeks)]
~*Carboplatin will be replaced by Cisplatin"
16269200|NCT00870844|Drug|Lu AA24493 (CEPO)|0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
16269201|NCT00870844|Drug|Placebo|Vials with solution for IV infusion
16269202|NCT00870831|Other|OGTT (Oral Glucose Tolerance Test)|Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide
16269203|NCT00870818|Drug|Teplizumab|No additional drug or placebo will be administered in this study. Blood will be drawn every 6 months after the last visit of the Protege Study for 3 years. Blood will be collected for chemistry, hematology, thyroid function, immunology, serology, autoantibodies, and metabolic function.
16269204|NCT00870805|Procedure|bilateral ultrabrief ECT|Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
16269205|NCT00870805|Procedure|bilateral standard ECT|Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
16269360|NCT00869661|Drug|RO5024048|1000mg bid for 12 weeks
16269206|NCT00870805|Procedure|right-unilateral ultrabrief ECT|Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
16269207|NCT00870805|Procedure|right-unilateral standard ECT|Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
16269208|NCT00870792|Behavioral|Adherence report|During the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression.
16269209|NCT00870779|Drug|5-aminolevulinic acid|20mg/kg 3 hours prior to surgery
16269210|NCT00870766|Procedure|Abdominal contrast-enhanced CT scanning|Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning
16269211|NCT00870753|Behavioral|Yoga|90 min hatha yoga 2 times per week for 12 weeks.
16269212|NCT00870740|Biological|BIIB019 (Daclizumab High Yield Process)|SC injection
16269213|NCT00870740|Drug|Placebo|Placebo SC injection
16269214|NCT00870727|Drug|Aripiprazole oral product|Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.
16269215|NCT00870727|Drug|Placebo oral capsule|Placebo will be identical in size and appearance to study drug.
16269216|NCT00870714|Drug|Docetaxel|Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.
16269217|NCT00870714|Drug|Ketoconazole|Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.
16269218|NCT00870701|Radiation|Radiotherapy|50 grays in 25 fractions of 2 Gys or 50.4 grays in 28 fractions of 1.8 grays
16269219|NCT00870701|Other|absence of radiotherapy|absence of radiotherapy
16269220|NCT00870688|Drug|sodium valproate|valproate sustained release minitablets, once daily.
16269221|NCT00870662|Device|AFS System|AFS System with patient specific flow rate
16269222|NCT00870649|Biological|Bilhvax vaccine (Sh28GST)|Four vaccine sc administrations over a year associated with chemotherapy (PZQ)
16269223|NCT00870649|Biological|placebo|Four placebo sc administrations over a year associated with chemotherapy (PZQ)
16269224|NCT00870636|Drug|Bevacizumab (Avastin)|Dosage of 0.75mg/0.03ml intravitreal injectable, one time only.
16269225|NCT00870610|Procedure|retrograde jugular venous cannulation|Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.
16269226|NCT00870597|Procedure|Multifocal IOL implantation + Vitrectomy|25-gauge transconjuntival sutureless vitrectomy (TSV)
16269227|NCT00870597|Procedure|Multifocal IOL implantation - Vitrectomy|Multifocal IOL implantation without transconjunctival vitrectomy
16269228|NCT00870584|Drug|Omalizumab|Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
16269229|NCT00870584|Drug|Placebo|Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
16269230|NCT00870571|Drug|AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose|A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
16269231|NCT00870571|Drug|NorvasC® 10 mg Tablets|B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions
16269232|NCT00870558|Drug|ethiodized oil|Given as an intra-arterial infusion
16269233|NCT00870558|Radiation|iodine I 131 ethiodized oil|Given as an intra-arterial infusion
16269234|NCT00870545|Behavioral|Telephone support groups|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
16269235|NCT00870532|Drug|oral vinorelbine|The patients will be divided into 3 cohorts (15 patients per cohort), each cohort receiving a fixed metronomic (thrice a week) dose of oral vinorelbine at 60 mg/week, 90 mg/week, and 120 mg/week respectively. We should arrive at 3 different MTDs from the 3 cohorts.
16269236|NCT00870532|Drug|sorafenib|Each patient within each cohort will receive a starting dose of sorafenib at 200 mg bid for 4 weeks. In the absence of dose-limiting toxicities, the dose of sorafenib will be escalated to 400 mg bid for another 4 weeks, 600 mg bid for 4 weeks and then finally 800 mg bid. We should arrive at 3 different MTDs from the 3 cohorts.
16269237|NCT00870519|Drug|I-123-MNI-168|Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.
16269238|NCT00870519|Drug|123-I MNI-168|Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.
16269239|NCT00870506|Behavioral|video|5-minute video compared (intervention) to no video and no other intervention (control)
16269240|NCT00870493|Drug|Aliskiren|Aliskiren 300 mg daily oral
16269241|NCT00870493|Drug|Placebo|starch tablet, 300 mg/day
16269242|NCT00870480|Drug|Finasteride 5 mg Tablet, single dose|A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fasting conditions
16269243|NCT00870480|Drug|Proscar® 5 mg Tablet, single dose|B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fasting conditions
16269244|NCT00870467|Biological|Double-blind adalimumab|Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
16269245|NCT00870467|Drug|Double-blind Placebo|Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
16269246|NCT00870467|Biological|Open-label Adalimumab|Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
16269247|NCT00870467|Biological|Open-labelAdalimumabRescue|Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
16269248|NCT00870454|Drug|Pregabalin 300 mg/d|75 mg/d twice daily for Week 1, followed by 150 mg twice daily for the remainder
16269249|NCT00870454|Drug|Carisbamate 800 mg/d|200 mg/d twice daily, titrated up to 400 mg twice daily, as tolerated, by Week 3
16269250|NCT00870454|Drug|Carisbamate 1,200 mg/d|200 mg/d twice daily, titrated up to 600 mg twice daily, as tolerated, by Week 3
16269251|NCT00870454|Drug|Placebo|Placebo capsules twice daily
16269252|NCT00870441|Drug|ASP2151|Oral
16269253|NCT00870441|Drug|Valacyclovir|Oral
16269254|NCT00870441|Drug|Placebo|Oral
16269255|NCT00870415|Procedure|quality-of-life assessment|
16269256|NCT00870415|Procedure|therapeutic conventional surgery|
16269257|NCT00870402|Drug|Spironolactone|25 mg per day for 9 months
16269258|NCT00870402|Drug|Placebo|Placebo 1 tablet per day for nine months
16269259|NCT00870376|Other|biomarkers|To define a biomarker or combination of overactive bladder syndrome
16269260|NCT00870363|Drug|maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)|maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
16269261|NCT00870363|Drug|maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)|maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
16269262|NCT00870363|Drug|efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]|efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician
16269263|NCT00870350|Biological|Td5ap|Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.
16269264|NCT00870350|Biological|Td1aP|Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.
16269265|NCT00870337|Drug|everolimus|
16269266|NCT00870324|Device|OptiSense Lead|"The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and narrow-spaced compared to the Tendril lead."
16269267|NCT00870324|Device|Tendril Lead|"The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is wide spaced compared to the OptiSense lead."
16269268|NCT00870311|Drug|Lithium Carbonate|300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules.
16269269|NCT00870298|Drug|Trimethoprim/Sulfamethoxazole and Warfarin|
16269270|NCT00870285|Radiation|UVB 311nm radiation|UVB-311nm radiation given 3 times a week to one randomized body-half
16269271|NCT00870272|Drug|Misoprostol|400mcg misoprostol taken sublingually or buccally
16269272|NCT00870259|Dietary Supplement|Optifast VLCD|Meal replacement, three times daily for 8 weeks
16269273|NCT00870233|Behavioral|online platform WEBCORE|Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
16269274|NCT00870220|Drug|Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch|GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3.
16269275|NCT00870207|Behavioral|Tu Salud Si Cuenta Worksite Intervention|The intervention will consist of providing TSSC newsletters to employees of the worksite. Additionally, informational sessions about physical activity and healthful food choice (consistent with the TSSC messages) during work hours will be implemented. Social support groups for the behavior changes will be established thru colleague networks. Individualized behavior change plans will be designed for enrolled participants. Additionally, environmental changes including a well equipped exercise facility on site and access to healthful foods in vending machines and work groups providing fruit and vegetable access in kitchen area will be implemented.
16269276|NCT00870194|Drug|exenatide and sitagliptin|exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
16269277|NCT00870194|Drug|exenatide and placebo|exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
16269278|NCT00870181|Biological|ADV-TK/GCV|gene therapy
16269279|NCT00870181|Procedure|Surgery|
16269280|NCT00870181|Drug|systemic chemotherapy|
16269281|NCT00870168|Drug|chemotherapy|
16269282|NCT00870168|Genetic|gene expression analysis|
16269283|NCT00870168|Other|laboratory biomarker analysis|
16269284|NCT00870168|Procedure|breast biopsy|
16269285|NCT00870155|Drug|dirucotide|500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
16269286|NCT00870142|Drug|AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose|A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fasting conditions
16269287|NCT00870142|Drug|Norvasc® 10 mg Tablets|B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions
16269361|NCT00869648|Procedure|Extension|After anaesthesia induction the head is placed in extension
16269288|NCT00870129|Procedure|MRI and advanced MRI sequences|This is a nonrandomized study in which each patient will receive the standard clinical care (in the form of surgery, radiation therapy and/or chemotherapy), as per the treating physician. Surgical resection will be performed at the discretion of the treating Neurooncologist and/or Neurooncology Tumor Board. Advanced brain MRIs with the 2 (or, in some cases, 3) special sequences will be obtained at the time of the clinically scheduled contrast MRIs, which are usually obtained immediately prior to and 1 months±3 weeks after radiation therapy if the patient requires radiation therapy for his/her tumor. The advanced brain MRI may also be obtained before surgery for suspected or confirmed gliomas, as per the standard of care, in some patients who may or may not require radiation therapy.
16269289|NCT00870116|Radiation|SBRT by cyberknife|treatment = 2x15 Gy during 2 weeks
16269290|NCT00870116|Radiation|SBRT by linear accelerator|treatment = 2x15 Gy during 2 weeks
16269291|NCT00870116|Radiation|Conformational radiotherapy|treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
16269292|NCT00870103|Drug|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops|1 drop every 6 hours into the study eye
16269293|NCT00870077|Dietary Supplement|ProWHEY 94 CFM, SponserR|3 times 20g per day
16269294|NCT00870064|Procedure|Formal Operative Treatment|Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
16269295|NCT00870064|Procedure|Emergency Department Treatment|Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
16269296|NCT00870051|Device|Endurant Stent Graft|Endurant Stent Graft implantation
16269297|NCT00870038|Device|Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent|Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent
16269298|NCT00870038|Device|Percutaneous coronary intervention: Uncoated balloon + Genous stent|Predilatation with uncoated balloon, the stenting with Genous stent.
16269299|NCT00870038|Device|Percutaneous coronary intervention: Drug eluting stent (Taxus stent)|Predilatation with uncoated balloon, the placement of a Taxus stent.
16269300|NCT00870025|Biological|human chorionic gonadotropin|200 IU, sc, every 5 days, 4 doses
16269301|NCT00870025|Biological|placebo|diluent, every 5 days, s.c., 4 doses
16269302|NCT00870012|Drug|Lepicol probiotic & prebiotic formula|NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.
16269303|NCT00870012|Other|Simple lifestyle advice|NAFLD patients treated with lifestyle advice.
16269304|NCT00869999|Drug|Everolimus|Taken orally once daily in the morning
16269305|NCT00869999|Drug|rituximab|Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6
16269306|NCT00869986|Drug|dirucotide|500mg, intravenous, every 6 months for 15 months
16269307|NCT00869986|Drug|placebo|intravenous, once every six months for 15 months
16269308|NCT00869973|Drug|Aprepitant|Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3
16269309|NCT00869973|Drug|dexamethasone|dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3
16269310|NCT00869960|Drug|tenofovir|tenofovir 300 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle)
16269311|NCT00869960|Drug|emtricitabine|emtricitabine 200 mg on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).
16269312|NCT00869960|Drug|atazanavir|atazanavir 300mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).
16269313|NCT00869960|Drug|ritonavir|ritonavir 100 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).
16269314|NCT00869947|Device|Powered ankle-foot prosthesis|The powered ankle-foot prosthesis is comprised of a series-elastic actuator (SEA) and an elastic leaf spring. This technology has been previously developed for robotic and human rehabilitation applications. The SEA allows for precise force control of the ankle joint, thus mimicking the spring-like behavior of the human ankle, as well as providing adequate energy for forward progression of the body. From the early stance period to the mid-stance period of walking, the SEA will be controlled so that the ankle joint behaves like a spring. During the late stance period, the SEA will be employed to power the forward movement of the body. The elastic leaf spring will provide shock absorption during foot strike, energy storage during early stance, and energy return during late stance.
16269315|NCT00869947|Other|No device|
16269316|NCT00869934|Other|Cognitive-Behavior Therapy|Sleep restriction, stimulus control, cognitive therapy
16269317|NCT00869934|Other|Behavior Therapy|Sleep restriction and stimulus control
16269318|NCT00869934|Other|Cognitive Therapy|Cognitive restructuring therapy
16269319|NCT00869908|Drug|insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16269320|NCT00869908|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16269321|NCT00869908|Drug|biphasic insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16269322|NCT00869895|Drug|E7050|Oral dosing starting at 100 mg once daily. After the MTD of once daily dosing has been determined, subsequent cohorts will be treated with a divided dosing schedule either twice or three times daily. The starting dose for this schedule will be an appropriate level below the MTD for once daily dosing.
16269362|NCT00869648|Procedure|Neutral head position|After anaesthesia induction the head is placed in neutral position
16269363|NCT00869648|Procedure|Anaesthesiologist's position|after anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist
16269364|NCT00869635|Drug|S-1 Chemotherapy|S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, <1.25m2: 80mg/day, 1.25~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
16269365|NCT00869635|Procedure|Photodynamic therapy|PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
16269366|NCT00869635|Procedure|Systemic chemotherapy except S-1|Variable systemic chemotherapy except S-1
16269323|NCT00869882|Procedure|Circumferential arthrodesis|"Patients are carefully positioned in the proned position and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs which can be performed at surgeon's demand during the whole surgery time.
~The preceding procedure is performed. In case of foraminal stenosis, decompression is performed at the same time as discal approach via the narrowest foramen.
~In addition to this, before preparation of bed for bone grafting, nerve roots are retracted and the disc nucleus is removed entirely, then endplate decortication is performed. The disc space is distracted. The most anterior part of the disc space is packed with cancellous bone. A cage packed with bone is inserted into the anterior portion of the interspace. According to cage location, bone graft could be inserted in the posterior portion of the interspace. Cage placement is radiologically checked.
~The end of the procedure is the same as for GPLI."
16269324|NCT00869882|Procedure|Posterolateral fusion with instrumentation|"Patients are carefully positioned in pronation and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs performed at surgeon's demand during the whole surgery time.
~Pedicle screw instrumentation is performed, followed by posterior neural decompression depending on the type of stenosis:
~Central stenosis: decompression is performed including medial facectomy, laminectomy;
~Foraminal stenosis: foraminotomy is performed, while preserving a graft bed as large as possible;
~Pure foraminal stenosis: spinal duct is not opened. Local bone is harvested from the lamina and the spinous process and carefully fragmented for autologous graft.
~Subperiosteal dissection is performed between the transverse processes and lateral aspects of the facet joints.
~Two rods are placed and locked on screws in maximum compression to optimize segmental lordosis.
~Bone autograft is placed into this bed."
16269325|NCT00869869|Drug|melatonin|2.5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
16269326|NCT00869869|Drug|placebo|placebo
16269327|NCT00869856|Drug|HX575 solution for s.c. administration|Containing different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh
16269328|NCT00869843|Procedure|RF Ablation|
16269329|NCT00869830|Other|biofeedback therapy|biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
16269330|NCT00869804|Behavioral|Aerobic/ Resistance Exercise Intervention|The intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands.
16269331|NCT00869804|Behavioral|Attention control|
16269332|NCT00869791|Drug|IPX066|experimental drug product: extended-release carbidopa-levodopa capsules
16269333|NCT00869791|Drug|IR CD-LD|active comparator: immediate-release carbidopa-levodopa capsules
16269334|NCT00869778|Biological|εPA-44|subcutaneously injection of εPA-44 at week 0, 4, 8, 12, 20, 28.
16269335|NCT00869778|Other|Placebo|subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28.
16269336|NCT00869765|Drug|D-Cycloserine|100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.
16269337|NCT00869765|Device|tDCS (Eldith DC-Stimulator (CE certified))|tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
16269338|NCT00869752|Biological|anti-IGF-1R recombinant monoclonal antibody MK-0646|MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days
16269339|NCT00869752|Drug|cisplatin|MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days
16269340|NCT00869752|Drug|etoposide|MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days
16269341|NCT00869739|Behavioral|telephone-based intervention|
16269342|NCT00869739|Other|educational intervention|
16269343|NCT00869739|Other|partner-assisted coping skills training|
16269344|NCT00869739|Other|questionnaire administration|
16269345|NCT00869739|Procedure|psychosocial assessment and care|
16269346|NCT00869739|Procedure|quality-of-life assessment|
16269347|NCT00869726|Drug|dirucotide|500mg, intravenous, dosed once every six months for 18 months
16269348|NCT00869726|Drug|Placebo|intravenous, once every six months for 18 months
16269349|NCT00869713|Biological|Inactivated, Dried (TSI-GSD 200), RVF Vaccine|All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 & 14, & once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer <1:40. Initial non-responders: Individual who has a PRNT80 titer <1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 <1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of <1:40.
16269350|NCT00869700|Drug|Artemether/Lumefantrine|"80mg artemether/480mg lumefantrine
~Trade name: Coartem
~Indication: for management of non-severe malaria"
16269351|NCT00869687|Device|Poly-L-Lactic Acid Injection|0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).
16269352|NCT00869674|Procedure|GeneSearch™ Breast Lymph Node (BLN) Assay|"Each of the sentinal lymph node will be divided in half according to cutting scheme.
~Half of the sentinal lymph node will be tested using rountine pathological method as normal practice, half of the node will have GeneSearch BLN testing."
16269353|NCT00869661|Drug|Copegus|1000/1200mg po daily for 24 or 48 weeks
16269354|NCT00869661|Drug|Copegus|1000/1200mg po daily for 48 weeks
16269355|NCT00869661|Drug|Pegasys|180 micrograms sc weekly for 24 or 48 weeks
16269356|NCT00869661|Drug|Pegasys|180 micrograms sc weekly for 48 weeks
16269357|NCT00869661|Drug|RO5024048|1000mg bid for 24 weeks
16269358|NCT00869661|Drug|RO5024048|500mg bid for 12 weeks
16269359|NCT00869661|Drug|RO5024048|1000mg bid for 8 weeks
16269368|NCT00869622|Drug|Placebo + Calcium and Vitamin D|sugar pill + calcium 1200mgs/day and vitamin d at least 800IU
16269369|NCT00869609|Behavioral|GLB Traditional Maintenance (TM)|After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
16269370|NCT00869609|Behavioral|GLB-Carb-focused Maintenance (CF)|After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
16269371|NCT00869596|Drug|fluticasone propionate|Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods
16269372|NCT00869596|Drug|Comparator: Placebo to fluticasone|Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
16269373|NCT00869596|Drug|Comparator: Lipopolysaccharide (LPS)|20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
16269374|NCT00869596|Drug|Comparator: albuterol|Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.
16269375|NCT00869583|Behavioral|Physical Activity Program|Participants will receive counseling from a community health educator that will focus on the importance of increasing physical activity. Participants will be encouraged to engage in moderate physical activity (3.0 to 6.0 metabolic equivalents [METS]) for 30 minutes on 5 or more days per week. Participants will be encouraged to start their physical activity program slowly and to gradually increase both frequency and intensity to meet the study goal (e.g., beginning with three sessions per week for 15 minutes and building up to five sessions per week for 30 minutes by Week 12). They will receive educational materials and telephone calls or visits from health educators on a monthly basis for 6 months.
16269376|NCT00869570|Drug|capecitabine|Phase II: 2 x 825 mg/m2 per day (during 5 weeks)
16269377|NCT00869570|Drug|sorafenib tosylate|Phase II: 1 x 400 mg per day (during 5 weeks)
16269378|NCT00869570|Radiation|radiation therapy|Phase II: 1.8 Gy per day in 25 fractions (during 5 weeks)
16269379|NCT00869557|Drug|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)
16269380|NCT00869557|Drug|Atripla|Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD
16269381|NCT00869531|Other|wholegrain|wholegrain wheat vs. refined wheat products
16269382|NCT00869531|Other|refined wheat|refined wheat products
16269383|NCT00869518|Drug|rifabutin plus trimethoprim sulfamethoxazole|rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days
16269384|NCT00869518|Drug|placebo plus trimethoprim-sulfamethoxazole|placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days
16269385|NCT00869492|Drug|benzoyl peroxide|benzoyl peroxide %5 solution once dailly
16269386|NCT00869492|Drug|nadifloxacine|Nadifloxacine 1% cream twice dailly
16269387|NCT00869466|Behavioral|behavioral dietary intervention|
16269388|NCT00869466|Behavioral|exercise intervention|
16269389|NCT00869466|Other|counseling intervention|
16269390|NCT00869466|Other|educational intervention|
16269391|NCT00869466|Other|laboratory biomarker analysis|
16269392|NCT00869466|Other|questionnaire administration|
16269393|NCT00869466|Procedure|quality-of-life assessment|
16269394|NCT00869466|Procedure|support group therapy|
16269395|NCT00869453|Other|test meal|Mixed meal containing bread, butter, beef
16269396|NCT00869453|Other|glucose|administration of a glucose meal
16269397|NCT00869453|Other|fat|administration of a lipid meal
16269398|NCT00869453|Other|protein|administration of a protein meal
16269399|NCT00869453|Other|control|no meal
16269400|NCT00869440|Drug|CNS 7056|Administered as a single intravenous injection by a syringe driver over 1 minute
16269401|NCT00869440|Drug|Midazolam|Administered as a single intravenous injection by a syringe driver over 1 minute
16269402|NCT00869427|Drug|vitamin C|vitamin C 1g bid for 1 year
16269403|NCT00869414|Drug|Evening only administration of insulin glargine|Evening only administration of insulin glargine, with normal saline injection administered in the morning.
16269404|NCT00869414|Drug|Morning only administration of insulin glargine|Morning only administration of insulin glargine, with normal saline injection administered at night.
16269405|NCT00869414|Drug|split dose insulin glargine|split dose of insulin glargine, half administered in the morning, half administered in evening
16269406|NCT00869401|Drug|dasatinib|Given orally
16269407|NCT00869401|Drug|temozolomide|Given orally
16269408|NCT00869401|Other|placebo|Given orally
16269409|NCT00869401|Radiation|radiation therapy|Radiation therapy is performed as 30 fractions of 200 cGy for a total of 6000 cGy.
16269410|NCT00869388|Biological|rBBX-01|
16269411|NCT00869375|Device|Endovascular peripheral intervention|Clearway Balloon: percutaneous transluminal angioplasty with simultaneous in situ thrombolysis using the Clearway balloon AngioJet Rheolytic Thrombectomy System: percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy using the Angiojet
16269412|NCT00869362|Other|Diabetes management team|MD evaluation followed by NP education and and medication titration
16269456|NCT00869115|Drug|Istaroxime|Istaroxime 1.5 μg/kg/min (90 μg/kg/h) continuous i.v. infusion for 24 hours
16269457|NCT00869115|Drug|Istaroxime|Placebo continuous i.v. infusion for 24 hours
16269458|NCT00869102|Drug|GLP-1|intravenous, 124,5 pmol/kg body weight
16269459|NCT00869089|Drug|CC-10004|30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
16269460|NCT00869076|Other|Pharmacist Management|Pharmacist Managed the patient's diabetes in collaboration with their primary care physician
16269413|NCT00869349|Behavioral|IFS|"The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.
~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
16269414|NCT00869349|Other|Education|The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
16269415|NCT00869336|Drug|Luliconazole Cream 1% - 2 wks|Topical cream applied daily for 2 weeks
16269416|NCT00869336|Drug|Placebo Comparator -2 wks|Placebo cream applied daily for 2 weeks
16269417|NCT00869336|Drug|Luliconazole Cream 1% - 4 wks|Topical cream applied daily for 4 weeks
16269418|NCT00869336|Drug|Placebo Comparator - 4 wks|Placebo cream applied daily for 4 weeks
16269419|NCT00869323|Biological|rituximab|375 mg/m^2 intravenously on Days 1,8, 15 and 22
16269420|NCT00869323|Drug|bortezomib|1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22
16269421|NCT00869310|Drug|aprepitant + dexamethasone|Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.
16269422|NCT00869310|Drug|metoclopramide + dexamethasone|dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4.
16269423|NCT00869297|Other|Goal Directed Fluid Administration|Intravenous Fluid will be given if SVV exceeds 13%
16269424|NCT00869297|Other|Control|Fluids titrated at discretion of anesthesiologist.
16269425|NCT00869284|Drug|CEEP regimen|cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals
16269426|NCT00869284|Procedure|Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)|"The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4.
~The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8."
16269427|NCT00869271|Procedure|tac + folfox4|"tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
~folfox4
~Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again."
16269428|NCT00869271|Procedure|Folfox4|"folfox4
~Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle"
16269429|NCT00869258|Drug|Gemcitabine, docetaxel, and capecitabine|Day 1-14: Capecitabine 1500 mg/m2/day (+/- 2days) Day 4 and 11: Gemcitabine 750 mg/m2/day (+/- 2days) Day 4 and 11: Docetaxel 30 mg/m2/day (+/- 2 days) Two week treatment regimen is followed by one week off, repeated for a total of 3 cycles
16269430|NCT00869258|Radiation|Radiation therapy with gemzar|Starting on week 12 +/- 5 days radiation therapy will be given in the standard manner over 5 weeks with daily radiation fractions Monday through Friday. Once a week gemcitabine will be given IV over 30 minutes at 250-300 mg/m2
16269431|NCT00869245|Other|OU - Cardiac MRI|During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
16269432|NCT00869245|Other|OU - Conventional Care Testing|Patients in the conventional testing arm will undergo testing as determined by their treating physician.
16269433|NCT00869232|Drug|Velcade|1.0mg/m2 days 1, 5, 8, & 11
16269434|NCT00869232|Drug|Melphalan|10 mg/m2 day 3
16269435|NCT00869232|Drug|Thalidomide|200 mg days 5-8
16269436|NCT00869232|Drug|Dexamethasone|40 mg day 5-8
16269437|NCT00869232|Drug|Cisplatin|10 mg/m2 day 5-8
16269438|NCT00869232|Drug|Adriamycin|10 mg/m2 day 5-8
16269439|NCT00869232|Drug|Cyclophosphamide|400 mg/m2 day 5-8
16269440|NCT00869232|Drug|Etoposide|40 mg/m2 day 5-8
16269441|NCT00869219|Drug|Nevanac|1 drop of NEVANAC at random eye
16269442|NCT00869219|Drug|Acular LS|One drop of Acular LS
16269443|NCT00869206|Drug|zoledronic acid|Given IV
16269444|NCT00869193|Dietary Supplement|Grape seed extract|Subjects will daily consume one capsule with grape seed extract for 8 weeks.
16269445|NCT00869193|Dietary Supplement|Microcrystalline cellulose (placebo)|Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
16269446|NCT00869180|Drug|Diclofenac Sodium|Topical diclofenac patch applied once daily to area of pain
16269447|NCT00869180|Drug|Matching Placebo Patch|Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
16269448|NCT00869167|Drug|Ramelteon|melatonin agonist
16269449|NCT00869154|Behavioral|primary care follow up|Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
16269450|NCT00869154|Behavioral|Multidisciplinary follow up|Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.
16269451|NCT00869141|Drug|glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)|Subjects may receive glaucoma medications after Ahmed valve implantation
16269452|NCT00869128|Drug|Circadin|2 mg prolonged-release melatonin
16269453|NCT00869128|Drug|Placebo|
16269454|NCT00869115|Drug|Istaroxime|Istaroxime 0.5 μg/kg/min (30 μg/kg/h) continuous i.v. infusion for 24 hours
16269455|NCT00869115|Drug|Istaroxime|Istaroxime 1.0 μg/kg/min (60 μg/kg/h) continuous i.v. infusion for 24 hours
16269461|NCT00869076|Other|Usual care|Patient was managed by their primary care physician as usual
16269462|NCT00869063|Drug|Diclofenac Sodium Patch|Topical 1% diclofenac sodium patch, applied once daily for 7 days
16269463|NCT00869063|Drug|Matching Placebo Patch|Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
16269464|NCT00869050|Drug|Capecitabine|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
16269465|NCT00869050|Drug|Temozolomide|"Temozolomide 150-200 mg/m2/day (PO divided BID).
~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
16269466|NCT00869037|Drug|Periarticular Injection|A 20 ml bolus of saline will be given through the sham femoral nerve block catheter. Periarticular infiltration solution containing 400 mg Ropivicaine, 30 mg Ketorolac, 5 mg Epidural Grade Morphine, and 0.6 ml of 1:1000 Epinephrine will be made up to a volume of 100 ml with saline. Intra-op, 20 ml will be injected into the posterior capsule; 40 ml in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 40 ml in the skin and subcutaneous tissues. The sham catheter will be connected to a saline infusion running at 15 ml/hr until the morning of post-operative day 2.
16269467|NCT00869037|Drug|CFNB + Posterior Capsular Injection|A 20 ml bolus of 0.2% Ropivacaine will be given via a femoral nerve catheter. Periarticular infiltration will be performed intra-op. 20 ml of 1% Ropivacaine in the posterior capsule; 20 ml of normal saline in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 20 ml of normal saline for the skin and subcutaneous tissues. Postoperatively, the femoral catheter will be infused with 0.15% Ropivacaine running at 15 ml/hour until the morning of post-operative day 2
16269468|NCT00869024|Biological|Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells|Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit).
16269469|NCT00869011|Other|Endurance exercise|Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
16269470|NCT00868998|Drug|Gemcitabine, docetaxel, and capecitabine|Day 1-14: Capecitabine 600 mg/m2/day (maximum dose 2000 mg/m2/day total divided into BID PO doses) Day 4 and 11: Gemcitabine 600 mg/m2 IV over 60 mins Day 4 and 11: Docetaxel 30 mg/m2 IV over 60 mins preceded by 12 mg dexamethasone IV or PO or 4 mg if diabetic
16269471|NCT00868985|Drug|PEG 3350 plus electrolytes|Each patient was treated with PEG 3350 with electrolytes for 10 days at a dose of either one, two or three sachets per day.
16269472|NCT00868985|Drug|PEG 3350 without electrolytes|Each patient was treated with PEG 3350 for 10 days at a dose of either one, two or three sachets per day.
16269473|NCT00868972|Procedure|Percutaneous renal stenting intervention|Percutaneous renal stenting intervention
16269474|NCT00868972|Device|Distal embolic protection|Distal embolic protection device (filter wire ex; Cordis Endovascular, USA).
16269475|NCT00868959|Drug|lurasidone|Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
16269476|NCT00868946|Drug|Virazole (Ribavirin)|"Duration of Subject Participation:7-day course of treatment with follow-up 28 - 60 days after first dose of IV ribavirin Route of Administration and Regimen:The drug is administered IV in a volume of 50-100 mL of normal saline to be infused over 30-40 minutes.
~Ribavirin Loading dose, 33 mg/kg (maximum dose: 2.64 g), followed by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses), and 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 3 days (9 doses)."
16269477|NCT00868933|Other|Low glycemic index dietary intervention program|The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
16269478|NCT00868933|Other|simple lifestyle advice|The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.
16269479|NCT00868920|Other|patient control of pump|Patient controls sedation pump during colonoscopy.
16269480|NCT00868920|Other|anesthesiologist controlled sedation|Anesthesiologist will control the sedation pump during colonoscopy.
16269481|NCT00868907|Drug|35 mg risedronate DR tablet|35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
16269482|NCT00868907|Drug|35 mg risedronate DR tablet|35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner
16269483|NCT00868907|Drug|35 mg risedronate DR tablet|35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
16269484|NCT00868894|Drug|DE-104 medium concentration|Topical ocular application
16269485|NCT00868894|Drug|DE-104 high concentration|Topical ocular application
16269486|NCT00868894|Drug|Placebo|Topical ocular application
16269487|NCT00868894|Drug|0.005% latanoprost|Topical ocular application
16269488|NCT00868855|Drug|Bradykinin|Bradykinin, 0.2 ug - 2ug/minute, one time intracoronary infusion over 6 minutes. Drug (bradykinin) will be infused into the left main coronary artery via diagnostic catheter (JL4) at an escalating rate of 0.2, 0.6, 2 g/ml (1ml/min). A 5F Multipurpose catheter will be advanced to coronary sinus for blood sampling.
16269489|NCT00868829|Device|Firebird2|For the patient participated, only Firebird2 Stent will be implanted.
16269490|NCT00868816|Drug|12 cycles of oxaliplatine based adjuvant chemotherapy|oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles
16269491|NCT00868816|Drug|8 cycles of oxaliplatine based adjuvant chemotherapy|oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles
16269492|NCT00868790|Drug|MK-3577|MK-3577 oral tablets totaling 6 mg in the evening (PM), 10 mg in the morning (AM), or 25 mg twice daily (BID) depending upon randomization, administered during a 4 week treatment period.
16269493|NCT00868790|Drug|Placebo to MK-3577|Dose-matched placebo tablets to MK-3577 administered during a 4 week treatment period
16269494|NCT00868790|Drug|Metformin|Two 500 mg tablets of metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.
16270233|NCT00863551|Drug|Trospium Chloride|Extended release, 60 mg, oral daily
16270234|NCT00863538|Drug|KPS-0373|
16269495|NCT00868790|Drug|Placebo to Metformin|Two placebo tablets to metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.
16269496|NCT00868777|Procedure|Sinus grafting using allogenic bone|Surgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth.
16269497|NCT00868764|Drug|granisetron|3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days
16269498|NCT00868751|Biological|tocilizumab|"Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.
~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
16269499|NCT00868738|Dietary Supplement|Vitamin D|Subjects will be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks.
16269500|NCT00868725|Other|no intervention, observation only|Oral cavity will be imaged by a thermal camera.
16269501|NCT00868699|Drug|lurasidone|lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
16269502|NCT00868699|Drug|lurasidone|lurasidone 20 mg/day for Days 1-7
16269503|NCT00868699|Drug|Placebo|Placebo Comparator
16269504|NCT00868686|Device|Volar aluminum splint|Alumafoam strip with padding removed, placed on the VOLAR aspect of the digit spanning the middle and distal phalanges only.
16269505|NCT00868686|Device|Dorsal aluminum splint|Alumafoam strip with padding removed, placed on the DORSAL aspect of the digit spanning the middle and distal phalanges only.
16269506|NCT00868686|Device|Custom thermoplastic|Customized thermoplastic splint with circumferential contact proximal to the joint and volar contact distal to the joint. This is a similar design to the original Stack splint, except that it is custom molded.
16269507|NCT00868673|Dietary Supplement|low fructose|"patients will receive a low fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). low fructose arm: a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of healthy fructose diet levels (less than 20 grams/day).Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done."
16269508|NCT00868673|Dietary Supplement|Normal fructose arm|patients will receive a normal fructose diet to evaluate possible changes in weight loss after a 6 week period of receiving a caloric intake (proteins, fats and carbohydrates) based on their healthy-desired weight. Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). Normal fructose arm: participants will receive a 6 week period of normal fructose diet between 50 to 70 grams/day. Baseline measurements and weekly monitoring of somatometry parameters (BMI, %body fat, waist and hip Index, blood pressure), lipid profile and uric acid levels will be done.
16269509|NCT00868660|Drug|ZP1848|sc. bolus
16269510|NCT00868647|Procedure|Radiofrequency ablation (RFA)|Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
16269511|NCT00868634|Drug|capecitabine|1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
16269512|NCT00868634|Drug|bevacizumab|15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
16269513|NCT00868634|Drug|capecitabine|1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
16269514|NCT00868634|Drug|bevacizumab|15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
16269515|NCT00868634|Drug|vinorelbine|25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
16269516|NCT00868608|Drug|Inotuzumab Ozogamicin (CMC-544)|Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
16269517|NCT00868595|Biological|BPX-101|Vaccine
16269518|NCT00868595|Drug|AP1903|Activating agent, infusion
16269519|NCT00868582|Other|PET scanning in cancer|Collection of institutional practice PET imaging data
16269520|NCT00868569|Procedure|TACE + folfox 4|"tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml
~folfox4"
16269521|NCT00868569|Procedure|TAC + folfox4|"tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
~folfox4"
16269522|NCT00868543|Procedure|laparoscopic gastric Roux-en-Y gastric bypass|The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 150cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
16269562|NCT00868231|Drug|Tiotropium 18 μg once-daily|Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.
16269563|NCT00868231|Drug|Placebo|Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.
16269564|NCT00868218|Biological|Influenza vaccine|"Influenza virus strain:
~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
16269565|NCT00868205|Dietary Supplement|Coffee consumption|3 or 5 cups of coffee daily for eight weeks
16269566|NCT00868192|Drug|Pemetrexed|
16269567|NCT00868192|Drug|Bevacizumab|
16269523|NCT00868543|Procedure|laparoscopic gastric Roux-en-Y gastric bypass|The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 250cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
16269524|NCT00868530|Biological|Xyntha|Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital).
16269525|NCT00868517|Other|True group auricular acupuncture|Received true group auricular acupuncture
16269526|NCT00868517|Other|Sham group auricular acupuncture|Received sham auricular acupuncture.
16269527|NCT00868517|Other|Wait-List Control Group|Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
16269528|NCT00868504|Other|no intervention|no intervention
16269529|NCT00868491|Drug|docetaxel, cisplatin, 5-fluorouracil|docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles
16269530|NCT00868491|Radiation|radiotherapy|Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol
16269531|NCT00868491|Drug|cetuximab, cisplatin|"cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20
~cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)"
16269532|NCT00868478|Drug|Milatuzumab|Milatuzumab will be given at a starting dose of 120 mg/m2, and then if no response or significant toxicity is seen after a total of 12 weeks, the dose will be gradually increased, by 120 mg/ m2 every four weeks, for a total of another 12 weeks.
16269533|NCT00868465|Drug|Artemether-Lumefantrine|Treatment with artemether-lumefantrine (AL; Coartem; Novartis Pharma), administered as half a tablet (20 mg of artemether and 120 mg of lumefantrine) per 5 kg of body weight in a 6-dose regimen (at enrolment and 8, 20, 32, 44, and 56 h [+/-90 min] after the initiation of treatment). AL is currently the first line treatment in Tanzania
16269534|NCT00868465|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine (DP; Artekin; Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets), with a dihydroartemisinin dose of 2.5 mg per kilogram and a piperaquine phosphate dose of 20 mg per kilogram daily for 3 days. DH is registered in Tanzania as Artekin and has been tested extensively in Asia and recently in clinical trials in Uganda and Rwanda
16269535|NCT00868452|Drug|lurasidone + (lithium or divalproex)|lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
16269536|NCT00868452|Drug|Placebo + (lithium or divalproex)|20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
16269537|NCT00868439|Drug|patiromer|Active investigational drug
16269538|NCT00868439|Drug|placebo|placebo
16269539|NCT00868426|Drug|Budesonide/Formoterol Batch 1|Single, inhaled dose
16269540|NCT00868426|Drug|Budesonide/Formoterol Batch 2|Single, inhaled dose
16269541|NCT00868426|Drug|Budesonide/Formoterol Batch 1 and charcoal|Single, inhaled dose
16269542|NCT00868413|Drug|ABT-263|ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
16269543|NCT00868413|Drug|FCR|Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle; Fludarabine will be given by intravenous infusion for 3 days out of each 28 day cycle; and Cyclophosphamide will be given by intravenous infusion for 3 days out of each 28 day cycle
16269544|NCT00868413|Drug|BR|Rituximab will be given by intravenous infusion for 2 days out of each 28 day cycle and Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle
16269545|NCT00868400|Dietary Supplement|commercially available high-carbohydrate beverage|800 ml before the day of surgery, and additional 400 ml two hours prior to surgery
16269546|NCT00868400|Dietary Supplement|flavored water|will be given in doses equal to those of high-carbohydrate beverage
16269547|NCT00868387|Other|energy-restricted, CHO-restricted diet|carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
16269548|NCT00868387|Other|energy-restricted, CHO-rich diet|carbohydrate content of diet > 55% Frequency: daily Duration: 12 months
16269549|NCT00868374|Drug|Quetiapine XR|Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
16269550|NCT00868374|Drug|Placebo|Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
16269551|NCT00868361|Drug|Talampanel (non-radiolabeled), [14C] Talampanel|50 mg capsule single dose
16269552|NCT00868348|Drug|Ketorolac|30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
16269553|NCT00868348|Drug|Saline|1 ml infiltration 4 ml intraarticular bolus injection of placebo
16269554|NCT00868335|Device|Activ C disc prosthesis|cervical disc prosthesis
16269555|NCT00868335|Procedure|Anterior cervical discectomy|Removal of protruding cervical disc through an anterior approach
16269556|NCT00868309|Biological|Anavip|Anavip, 10 vials Intravenous (IV) every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
16269557|NCT00868309|Biological|CroFab|CroFab, 5 vials Intravenous (IV) every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
16269558|NCT00868296|Drug|pantoprazole|
16269559|NCT00868283|Drug|Cerebrolysin|30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
16269560|NCT00868283|Drug|0.9% Saline Solution|30 ml will be given once daily by intravenous infusion for 10 consecutive days.
16269561|NCT00868231|Drug|Aclidinium bromide 400 μg bid|Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.
16269568|NCT00868179|Drug|Pradax|Pradax (dabigatran etexilate) is a prodrug that when converted to the active from in the liver and plasma it becomes a reversible, competitive direct thrombin inhibitor. Thrombin catalyses the conversion of soluble fibrinogen into soluble fibrin, the final step in the coagulation cascade. Pradax competitively blocks the active site of both free and clot-bound thrombin, preventing the development of a thrombus. they will take 110 mg 1-4 hours post op. and 220mg daily until 10 days post op.
16269569|NCT00868166|Drug|Olesoxime|2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid
16269570|NCT00868166|Drug|Placebo Comparator|2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid
16269571|NCT00868166|Drug|Riluzole|Riluzole given as add-on therapy 50mg bid
16269572|NCT00868153|Drug|Levonorgestrel IUS (Mirena , BAY86-5028)|One group
16269573|NCT00868140|Drug|pioglitazone|pioglitazone 45 mg
16269574|NCT00868140|Drug|Placebo|placebo daily
16269575|NCT00868127|Drug|Lapaquistat acetate|"Participants from 01-04-TL-475-008 Monotherapy Study:
~Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 48 weeks."
16269576|NCT00868127|Drug|Lapaquistat acetate and additional lipid-lowering therapy|"Participants from 01-04-TL-475-009 Atorvastatin Add-on Study:
~Lapaquistat acetate 100 mg, tablets, orally, once daily and current Atorvastatin therapy for up to 4 weeks.
~Then, Lapaquistat 100 mg, tablets, orally, once daily and dose adjustment of Atorvastatin OR additional companion lipid-lowering therapy as needed for target LDL-C for up to 42 weeks."
16269577|NCT00868114|Biological|KLH-pulsed autologous dendritic cell vaccine|5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks
16269578|NCT00868101|Procedure|Remote ischemic preconditioning|Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
16269579|NCT00868088|Procedure|PDT prior to Mohs surgery|"Day 1: Screening and consent for this study. If eligible, a scouting biopsy will be obtained at 1 cm from the clinical border of the SCC for confirmation of AC.
~7-14 Days after consultation: PDT to all subjects in the study. If during treatment a subject requests to discontinue due to pain the treatment will be terminated.
~3-5 weeks after consultation: return for assessment. At this visit, the assigned treatment may be repeated if the treatment site is adequately healed. Re-treatment will only occur if there is persistent actinic damage.
~6-8 weeks after consultation: Mohs surgery will be performed as per routine. Following tumor removal a scouting biopsy will be taken at a site 1 cm from the wound site created by SCC removal. The current waiting time for non-urgent surgery is 8 weeks. Standard care is not being altered for subjects in the study, other then their receiving the PDT intervention.
~Photographs may be taken at each subject visit."
16269580|NCT00868075|Procedure|Chest physiotherapy|Twice daily for 8 weeks
16269581|NCT00868075|Procedure|Chest Physiotherapy + Exercise Program|Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks
16269582|NCT00868062|Other|Succinylated gelatine, 40g/L, (Gelofusine - B Braun)|1 litre infusion following induction of anaesthesia
16269583|NCT00868036|Procedure|Patch Testing|"Patch testing will be performed with a modified North American Contact Dermatitis Group (NACDG) standard series, cosmetics/preservative, fragrance, and textile series in all patients. Based on patient history, other appropriate allergen series will be added. After two days, patches will be removed and the areas will be inspected for type IV hypersensitivity reactions including papules, edema or vesicles.
~Results will be graded and interpreted at a delayed read, 3-4 days after allergens are placed with patch testing."
16269584|NCT00868023|Drug|CHF 1535 Next DPI|CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
16269585|NCT00868023|Drug|Foster BDP/Formoterol|BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
16269586|NCT00868023|Drug|CHF 1535 Next DPI|CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
16269587|NCT00868023|Drug|Foster BDP/Formoterol|BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
16269588|NCT00868023|Drug|Placebo|Placebo
16269589|NCT00868010|Drug|donepezil|5 mg or 10 mg, titrated per drug insert. Participants may remain in the study at 5 mg if unable to tolerate 10 mg.
16269590|NCT00868010|Drug|placebo|Participants will receive a placebo pill for 12 weeks if randomized to this treatment.
16269591|NCT00867997|Other|Chemoactive (remineralizing, neuroactive) dentifrice treatment|Chemoactive (remineralizing, neuroactive) dentifrice treatment
16269592|NCT00867997|Other|Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F|Self-etch DBA followed by a hydrophobic resin layer
16269593|NCT00867997|Other|Clearfil S3 Bond; Premise Flowable resin-based composite|Restoration with a dentin bonding agent (DBA) and flowable resin-based composite
16269594|NCT00867984|Other|Torsion optimized|Torsion optimized VV timing plus AV optimization (VTI)
16269595|NCT00867984|Other|Usual Care|AV optimization (VTI) only
16269596|NCT00867971|Other|Measuring intraoccular pressure|Measurement of intraoccular pressure by tonometry
16269597|NCT00867958|Device|Compression Anastomosis Ring: CAR™ 27|Creation of anastomosis in colorectal surgeries using CAR™ 27
16269598|NCT00867932|Drug|Eculizumab|5 mg/mL solution in 5% Dextrose
16269599|NCT00867919|Behavioral|Behavioral Family Treatment|"11 to 15 sessions of a cognitive behavioral family therapy that will be developed during the course of this study and will address the following:
~parent-adolescent conflict
~adolescent development
~support and closeness
~behavioral activation
~response to adolescent negative affect
~relapse prevention
~suicide prevention, if necessary"
16269600|NCT00867919|Other|Community-based treatment as usual|Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment
16269601|NCT00867906|Biological|Cat-PAD|Cat-PAD dose 1x8 administrations 2 weeks apart
16269602|NCT00867906|Biological|Placebo|Placebo comparator, 1x8 administrations 2 weeks apart
16269603|NCT00867880|Drug|IVIb|800mg IVIb diluted in 200mL NS will be given IV (in the vein) concurrently with an oral placebo on Day 1 and 200ml Normal Saline will be given IV (in the vein)concurrently with 800mg oral ibuprofen on Day 8
16269604|NCT00867867|Drug|Ferrous fumarate|9.3 mg once per day, 6 days per week, for 9 months
16269605|NCT00867867|Drug|Ferric pyrophosphate|9.3 mg once per day, 6 days per week, for 9 months
16269606|NCT00867867|Drug|Placebo|9.3 mg once per day, 6 days per week, for 9 months
16270287|NCT00863174|Drug|Reference147709|Reference147709 injection
16269607|NCT00867854|Other|Blood draw|This sub-study does not involve additional treatment of any ATN 061 or ATN 071 study subjects. The only intervention involved is the requirement for whole blood collection (40 ml and 60 ml) to be drawn at the same time as four ATN 061 study visits (36, 48, 56, and 80 weeks) for subjects co-enrolled into ATN 061. When these time points coincide with ATN 061 Central Laboratory samples, the 60 ml blood sample will not be collected. For subjects co-enrolled into ATN 071, there are also two samples of whole blood collection (40 ml and 60 ml) required to be drawn at four time points but at weeks 36, 48, 56, and 80 after the initiation of HAART.
16269608|NCT00867841|Procedure|nasopharyngeal swab|PCR of NP swab for Mycoplasma, Chlamydophila, pneumococcus, pneumococcus macrolide resistance genes.
16269609|NCT00867828|Dietary Supplement|Neptune Krill Oil|Softgels 1g QD. Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.
16269610|NCT00867828|Dietary Supplement|Fish Oil|Softgels 1g QD. Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.
16269611|NCT00867828|Dietary Supplement|Placebo (soy oil)|Softgels 1g QD. The soy oil placebo will provide neither EPA nor DHA.
16269612|NCT00867815|Drug|Diagnostic procedures|The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
16269613|NCT00867802|Behavioral|Mindfulness-Based Stress Reduction program|Mindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes.
16269614|NCT00867789|Drug|Trimethoprim-sulfamethoxazole|10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
16269615|NCT00867789|Drug|Sugar pill|10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
16269616|NCT00867776|Behavioral|AAHC Exercise Program Support Group|6-week community-based, culturally tailored support group program, focusing on exercise and healthy lifestyle habits. Groups will also include basic psychoeducation about depression and depression care. Groups will have up to 20 participants and will meet weekly for 2 hours. By the end of the program, participants will be encouraged to create a personalized action plan focusing on exercise and other healthy lifestyle choices.
16269617|NCT00867763|Procedure|In vitro maturation and in vitro fertilization|No gonadotropin, eggs harvested early
16269618|NCT00867763|Procedure|Low doses of gonadotropin stimulation.|Gonadotropin followed by conventional IVF
16269619|NCT00867750|Device|Radioembolisation (SIR-Spheres® microspheres)|Yttrium-90 SIR-Spheres microspheres
16269620|NCT00867750|Drug|Transarterial Chemoembolisation|TACE with embolising agent Embospheres (150-300 μm or 300-500 μm diameter) with 50 mg of chemotherapeutic agent epirubicin admixed with 5 ml lipiodol.
16269621|NCT00867737|Drug|Advair HFA MDI 115/21|Two puffs from MDI twice daily for 4 weeks
16269622|NCT00867737|Drug|Symbicort 160/4.5 pMDI|"Symbicort 160/4.5 pMDI
~Two puffs from MDI twice daily for 4 weeks"
16269623|NCT00867724|Device|Aer-O-Scope Colonoscopy|Screening Colonoscopy
16269624|NCT00867698|Drug|AST-120|AST-120
16269625|NCT00867685|Drug|AZD2624|Single dose of 40 mg AZD2624 liquid suspension, PO
16269626|NCT00867685|Drug|AZD2624|Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
16269627|NCT00867672|Drug|Decitabine|i.v. Decitabine 20 mg/m² over 1h, 5 days (total dose 100 mg/m²), repeated every 4 weeks
16269628|NCT00867672|Drug|VPA|VPA starting on day 6 of first cycle continuously throughout all treatment cycles
16269629|NCT00867672|Drug|ATRA|ATRA (45 mg/m² p.o.) from day 6 to day 28 of each treatment cycle
16269630|NCT00867659|Drug|Cetrotide acetate|cetrotide acetate is a GnRH antagonist. The dose is 3 mg once on the day of oocyte retrieval.
16269631|NCT00867607|Drug|MRX-6|b.i.d treatment for 21 days
16269632|NCT00867607|Drug|Steroid|b.i.d. 21 days
16269633|NCT00867594|Drug|ORMD 0801|1 capsule ORMD 0801 3 times a day, before each meal
16269634|NCT00867568|Drug|TPI 287|Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
16269635|NCT00867555|Dietary Supplement|Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation|green tea extract TEAVIGO, high in EGCG
16269636|NCT00867542|Other|no intervention|no intervention
16269637|NCT00867529|Biological|rituximab|Given IV
16269638|NCT00867529|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
16269639|NCT00867529|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
16269640|NCT00867529|Other|pharmacological study|Correlative studies
16269641|NCT00867529|Other|laboratory biomarker analysis|Correlative studies
16269642|NCT00867516|Biological|ALD518|Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
16269643|NCT00867516|Biological|Infusion without ALD518'|250 cc Normal saline IV over one hour Weeks 1 and 8.
16269644|NCT00867503|Drug|Bendamustine HCL|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
16269645|NCT00867490|Drug|Candesartan+HCTZ - Phase 1|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
16269646|NCT00867490|Drug|Aliskiren+HCTZ - Phase 2|Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
16269697|NCT00867152|Drug|Darunavir|Darunavir 600 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Darunavir is approved by the FDA as an HIV medication in the protease inhibitor class.
16270288|NCT00863161|Drug|AZD3355|capsule, oral, single dose
16269647|NCT00867490|Drug|Aliskiren+HCTZ+amlodipine - Phase 3|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
16269648|NCT00867477|Procedure|Breathing Test|Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).
16269649|NCT00867477|Behavioral|Respiratory Symptoms Questionnaire|3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
16269650|NCT00867477|Procedure|Pet Scan|Between 40 and 50 days after the end of the radiation therapy. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility.
16269651|NCT00867464|Other|Cytology Specimen Collection Procedure|Correlative studies
16269652|NCT00867464|Other|Laboratory Biomarker Analysis|Correlative studies
16269653|NCT00867464|Other|Long-term Follow-up|Undergo extended follow-up
16269654|NCT00867464|Other|Questionnaire Administration|Ancillary studies
16269655|NCT00867451|Behavioral|Sleep Intervention|A structured sleep protocol is taught to parents, use of a white noise generator
16269656|NCT00867451|Drug|Melatonin|Body Weight <40mg will be given 3mg at bedtime for two weeks Body Weight >40mg will be given 6 mg at bedtime for two weeks
16269657|NCT00867438|Procedure|Sigmoidoscopy|
16269658|NCT00867425|Behavioral|Virtual Lifestyle Management|"The VLM online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program (1). VLM will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs.
~Participants will be encouraged to complete 16 online, weekly lessons. The VLM curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives. The VLM lifestyle coaching team will review these entries weekly, and provide support, feedback about progress, tips on how to problem-solve around lifestyle barriers, and guidance on how to use the Keeping Track functions of VLM (e.g. keeping track of weight, fat intake, calories or physical activity)."
16269659|NCT00867399|Drug|ABT-126|See arm for details
16269660|NCT00867373|Behavioral|Education Intervention|The intervention is a short educational handout regarding BMI and the effect of parental weight status on children.
16269661|NCT00867360|Drug|Mifepristone (RU-486)|
16269662|NCT00867360|Drug|Placebo|Placebo medication
16269663|NCT00867347|Procedure|therapeutic conventional surgery|Patients undergo radical cystectomy
16269664|NCT00867347|Radiation|radiation therapy|Patients undergo radiotherapy
16269665|NCT00867334|Drug|Imatinib mesylate and panitumumab|Patients will be entered into sequential cohorts with escalating doses of imatinib mesylate. After approximately 28 days of monotherapy treatment with imatinib mesylate, patients will be asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). All patients in this group will then receive imatinib mesylate in combination with standard-of-care doses of panitumumab. After approximately 1-2 months of combination treatment, patients will asked to have an additional liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). Combination treatment will continue for the remainder of the subject's time in the trial.
16269666|NCT00867334|Drug|Standard-of-care treatment with panitumumab|Panitumumab as standard of care. After approximately 2-3 months of standard of care treatment, patients will asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study).
16269667|NCT00867321|Biological|bevacizumab|Given IV
16269668|NCT00867321|Drug|sorafenib tosylate|Given orally
16269669|NCT00867308|Drug|Lenalidomide 50 mg|
16269670|NCT00867308|Drug|Lenalidomide 15 mg|
16269671|NCT00867295|Drug|cefazolin Sodium|cefazolin Sodium 1g i.v. before operation
16269672|NCT00867295|Drug|placebo|placebo
16269673|NCT00867282|Drug|Treatment A|PF-00241939 750ug using inhaler A
16269674|NCT00867282|Drug|Treatment B|PF-00241939 750ug using inhaler B
16269675|NCT00867256|Device|Large Diameter Metal on Metal|
16269676|NCT00867230|Drug|FTS|Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.
16269677|NCT00867217|Dietary Supplement|High Dose Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.
16269678|NCT00867217|Dietary Supplement|Placebo|Placebo comparator
16269679|NCT00867217|Dietary Supplement|Standard Dose Vitamin D3|Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)
16269680|NCT00867217|Drug|Letrozole 2.5mg|All subjects received letrozole as standard of care.
16269681|NCT00867204|Procedure|ERCP|Patients with clinical indication for ERCP were invited to participate in the Study
16269682|NCT00867191|Drug|Placebo|Placebo, 1 tablet daily, per os., 15 days
16269683|NCT00867191|Drug|Desloratadine|Desloratadine, one 5 mg tablet daily, per os, 15 days
16269684|NCT00867178|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo conformal radiation therapy
16269685|NCT00867178|Drug|Carboplatin|Given IV
16269686|NCT00867178|Drug|Cisplatin|Given IV
16269687|NCT00867178|Drug|Cyclophosphamide|Given IV
16269688|NCT00867178|Drug|Etoposide Phosphate|Given IV
16269689|NCT00867178|Drug|Isotretinoin|Given PO
16269690|NCT00867178|Other|Laboratory Biomarker Analysis|Correlative studies
16269691|NCT00867178|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC
16269692|NCT00867178|Drug|Thiotepa|Given IV
16269693|NCT00867178|Drug|Vincristine Sulfate|Given IV
16269694|NCT00867178|Drug|Vorinostat|Given PO
16269695|NCT00867165|Drug|ezetimibe|oral tablets: ezetimibe 10 mg once daily for 12 weeks
16269696|NCT00867165|Drug|Placebo|oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period
16270328|NCT00862888|Drug|Placebo|Placebo for oral solution
16270329|NCT00862888|Drug|Placebo|Placebo for tablet
16269698|NCT00867152|Drug|Etravirine|Etravirine 200 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Etravirine is approved by the FDA as an HIV medication in the non-nucleoside reuptake inhibitor class.
16269699|NCT00867152|Drug|Ritonavir|Ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.
16269700|NCT00867152|Drug|Lopinavir/ritonavir|Lopinavir 400 mg and ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Lopinavir/Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.
16269701|NCT00867152|Drug|GSK1349572|GSK1349572 50 q24h for 5 days in Period 1 and for 14 days in Period 2. GSK1349572 20 mg q12h for 14 days in Period 3 if Period 3 is done. GSK1349572 is an investigational (not approved by the FDA) HIV medication in the integrase inhibitor class.
16269702|NCT00867139|Drug|TCAD|TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
16269703|NCT00867139|Drug|Zanamivir or Oseltamivir|Zanamivir or Oseltamivir
16269704|NCT00867139|Other|Open label treatment with TCAD|TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
16269705|NCT00867126|Drug|pioglitazone hydrochloride|
16269706|NCT00867126|Other|laboratory biomarker analysis|
16269707|NCT00867126|Other|questionnaire administration|
16269708|NCT00867126|Procedure|quality-of-life assessment|
16269709|NCT00867113|Drug|imatinib mesylate|imatinib mesylate was supplied in 100 and 400 mg tablets
16269710|NCT00867100|Drug|700 mg IV|single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
16269711|NCT00867100|Drug|350 mg SC|single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
16269712|NCT00867100|Drug|Placebo|single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
16269713|NCT00867100|Drug|140 mg SC|single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
16269714|NCT00867087|Drug|inotuzumab ozogamicin (CMC-544)|1.8 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
16269715|NCT00867087|Drug|rituximab|375 mg/m^2 two days before cycle 1 by intravenous infusion; 375 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
16269716|NCT00867061|Drug|ON 01910.Na Concentrate|5-day continuous intravenous dosing of ON 01910.Na given every 2 weeks (1 cycle) at a dose of 800 mg/m2/day or 1500mg/m2/day for up to 24 cycles.
16269717|NCT00867048|Drug|All licensed antiretroviral medications|In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
16269718|NCT00867035|Drug|Chlorine dioxide and scraper|20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
16269719|NCT00867035|Drug|Chlorhexidine gluconate and scraper|The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.12% chlorhexidine gluconate rinse for 30sec, for one week.
16269720|NCT00867009|Drug|Pemetrexed|Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation
16269721|NCT00867009|Drug|Cisplatin|Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles
16269722|NCT00867009|Drug|Cetuximab|"Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles
~Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation"
16269723|NCT00866996|Drug|Methylphenidate extended-release; Atomoxetine|
16269724|NCT00866983|Drug|sildenafil (Revatio) 20 mg TID|To provide access to sildenafil for patients completing the A1481244 study, resides in Brazilian States where Revatio™ is not supplied by Health Secretary and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil. It will be supplied until the patient gets access to Sildenafil through Brazilian State Health Secretary from where the patient resides.
16269725|NCT00866970|Biological|ALD518|ALD518 80 mg on Day 1, Week 8 and Week 16
16269726|NCT00866970|Biological|ALD518|ALD518 160 mg IV on Day 1, Week 8 and Week 16
16269727|NCT00866970|Biological|ALD518|ALD518 360 mg IV on Day 1, Week 8, and Week 16
16269728|NCT00866970|Biological|Infusion of 0.9% Saline without ALD518|Infusion of 0.9% Saline without addition of ALD518
16269729|NCT00866957|Procedure|Blood draw|A two-time blood draw: one prior to cancer treatment, the second after cancer treatment. Total amount of blood approximately 8 teaspoons (40mL).
16269730|NCT00866944|Drug|Adecatumumab|Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
16269731|NCT00866944|Drug|Adecatumumab and FOLFOX|FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
16269732|NCT00866944|Drug|FOLFOX 4|FOLFOX 4, every 14 days, 12 cycles
16269733|NCT00866918|Drug|arsenic trioxide|Given IV
16269734|NCT00866918|Drug|mitoxantrone hydrochloride|Given IV
16269735|NCT00866918|Other|diagnostic laboratory biomarker analysis|Correlative studies
16269736|NCT00866918|Drug|idarubicin|Given IV
16269737|NCT00866918|Drug|tretinoin|Given orally
16269738|NCT00866918|Drug|cytarabine|Given IT or IV
16269739|NCT00866918|Drug|mercaptopurine tablet|Given orally
16269740|NCT00866918|Drug|methotrexate|Given orally
16269741|NCT00866905|Drug|Ixabepilone|40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles
16269742|NCT00866905|Drug|Cyclophosphamide|600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles
16269743|NCT00866892|Procedure|Irrigation|irrigation
16269744|NCT00866892|Procedure|No irrigation|no irrigation
16269745|NCT00866879|Drug|Sirolimus|Sirolimus will initially be given at a dose of 2-4 mg orally (PO) daily. The dose will be modified to achieve 24 hours trough concentrations of 6-10 ng/ml by high-performance liquid chromatography (HPLC) assay. This medication will be given in an open label fashion. The first dose of sirolimus will be given at the time of randomization to those patients assigned to have tacrolimus switched to sirolimus.
16270330|NCT00862888|Drug|Sildenafil|Single oral dose 100 mg tablet
16269746|NCT00866879|Other|Demographic Data, Medical History, and Donor Data|Age at transplant, sex, race, cause of end-stage renal disease, medical history, donor age, cadaveric vs. living kidney transplant, histocompatibility/cross match data, viral serology, history of acute rejection and delayed graft function, use of induction therapy and immunosuppressants, use of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blockers (ARB) level of renal allograft function-estimated GFR (e-GFR(12) using Modification of Diet in Renal Disease (MDRD) formula, proteinuria.
16269747|NCT00866879|Procedure|Blood Draws for Control Group|Subjects maintaining standard of care drug treatment of TAC and MMF will have monthly labs in addition to the baseline pre-randomization labs, at 6, 12, and 24 Months post-randomization. Peripheral blood leukocytes will be obtained.
16269748|NCT00866879|Procedure|Blood Draws for Experimental Group|This group will have monthly labs taken but will also have weekly labs during the period of conversion to monitor renal function and bone marrow function. In addition to the baseline pre-randomization labs, and labs collected at 6, 12, and 24 Months post-randomization, peripheral blood leukocytes will be obtained.
16269749|NCT00866879|Procedure|Donor Blood Draws|Peripheral blood leukocytes from living donors obtained at the time of randomization. These donor leukocytes will be used as stimulator cells to study the functional activity of the recipient's lymphocytes function.
16269750|NCT00866879|Other|Donor Information|Donor age, cadaveric vs. living donor, and histocompatibility and cross match to recipient
16269751|NCT00866879|Procedure|Kidney Biopsy|Kidney biopsy at 24 Months to compare to the standard of care biopsy taken at 12 Months. This information will help evaluate renal allograft pathology and renal allograft tissue gene expression profiles of the two groups. Renal allograft biopsies will be stored in RNA later (preservative) to further extend knowledge on the effect of calcineurin-inhibitors (CI) free immunosuppression on gene expression profiles.
16269752|NCT00866866|Drug|N-Acetyl Cysteine|600 mg PO BID
16269753|NCT00866866|Drug|Placebo|1 tab PO BID
16269754|NCT00866853|Drug|TMC435|
16269755|NCT00866840|Drug|riluzole|100 mg orally twice daily
16269756|NCT00866827|Other|Protocols for Treatment|Determine protocols for treatment of airway vascular malformation and to evaluate results from treatment of these lesions.
16269757|NCT00866814|Device|Bard Ventrio Hernia Patch|The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
16269758|NCT00866788|Drug|omalizumab|Administered by subcutaneous injection
16269759|NCT00866788|Drug|placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study.
16269760|NCT00866788|Drug|H1 antihistamines|Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
16269761|NCT00866788|Drug|Diphenhydramine|Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
16269762|NCT00866775|Drug|Eslicarbazepine acetate|1600 mg QD
16269763|NCT00866775|Drug|Eslicarbazepine acetate|1200 mg QD
16269764|NCT00866762|Drug|HDAC inhibitor (MK-0683)|400 mg once daily for 6 months
16269765|NCT00866749|Drug|Daunorubicin|Starting Dose 25 mg/m^2 by vein weekly
16269766|NCT00866749|Drug|Vincristine|Starting Dose 2 mg by vein weekly
16269767|NCT00866749|Drug|PEG-asparaginase|Starting Dose 2000 International units/m2 by vein in week 1
16269768|NCT00866749|Drug|Intrathecal Methotrexate|Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid
16269769|NCT00866749|Drug|Cyclophosphamide|Starting Dose 1g/m2 by vein in weeks 1 and 5
16269770|NCT00866749|Drug|Cytarabine|75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months
16269771|NCT00866749|Drug|Mercaptopurine|Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
16269772|NCT00866749|Drug|Methotrexate|"Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10
~+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3"
16269773|NCT00866749|Drug|Doxorubicin|25 mg/m2 by vein in weeks 1, 2 and 3
16269774|NCT00866749|Drug|Thioguanine|60 mg/m2 by mouth daily for two weeks
16269775|NCT00866736|Drug|dasatinib|100mg QD
16269776|NCT00866723|Drug|bevacizumab|
16269777|NCT00866710|Other|Exercise-based behavioral therapy|Participants will be taught pelvic floor muscle exercises as well as urge suppression strategies to overcome the urge to void. In the first 20 participants, computer-assisted biofeedback will also be utilized to help participants identify the pelvic floor muscles and contract and relax these muscles while keeping the abdominal muscles relaxed
16269778|NCT00866697|Drug|Pazopanib|Pazopanib 800 mg tablet daily for 104 weeks (24 months)
16269779|NCT00866697|Drug|Placebo|Matching placebo 800 mg tablet daily, for 104 weeks (24 months).
16269780|NCT00866684|Drug|Sirolimus|Dosage form: coated tablet; Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day; Duration: 24 month
16269781|NCT00866684|Drug|Azathioprine|Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
16269782|NCT00866684|Drug|Mycophenolate|Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
16269783|NCT00866684|Drug|Ciclosporin|Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
16269784|NCT00866684|Drug|Tacrolimus|Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
16269785|NCT00866671|Drug|nelarabine|Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.
16269786|NCT00866658|Drug|Lixisenatide (AVE0010)|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16269787|NCT00866658|Drug|Placebo|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16269788|NCT00866658|Device|Pen auto-injector|
16269789|NCT00866658|Drug|Sulfonylurea|Sulfonylurea if given, to be continued at a stable dose.
16269790|NCT00866658|Drug|Basal Insulin|To be continued at a stable dose.
16269791|NCT00866645|Drug|Intramuscular Haloperidol|1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.
16270331|NCT00862888|Drug|PF-00446687|Single 125 mg dose as an oral solution
16269792|NCT00866645|Drug|Intramuscular Levosulpiride|2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.
16269793|NCT00866632|Behavioral|Cognitive Behavioural Therapy|Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.
16269794|NCT00866632|Behavioral|Cognitive Behavioural Therapy|Cognitive behavioural therapy to be delivered in one-on-one via the telephone across 11 sessions, for 1 to 1.5 hours/session.
16269795|NCT00866619|Biological|Malaria Vaccine 257049|administered intramuscularly into the left deltoid.
16269796|NCT00866619|Biological|Meningococcal C Conjugate Vaccine|administered intramuscularly into the left deltoid.
16269797|NCT00866619|Biological|Cell-culture rabies vaccine|administered intramuscularly into the left deltoid.
16269798|NCT00866619|Biological|TritanrixHepB/Hib|administered intramuscularly into the left deltoid.
16269799|NCT00866619|Biological|Polio Sabin Oral Polio Vaccine (GSK)|administered orally.
16269800|NCT00866606|Biological|Benefix|BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.
16269801|NCT00866593|Drug|Generic Escitalopram|10mg/d or 20mg/d
16269802|NCT00866593|Drug|Innovator Escitalopram|10mg/d or 20mg/d
16269803|NCT00866580|Biological|GSK's candidate influenza vaccine 1562902A|Intramuscular dose on Day 0 and Day 21
16269804|NCT00866580|Biological|FluarixTM|Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
16269805|NCT00866580|Biological|Placebo|Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
16269806|NCT00866554|Drug|administration of a LHRH agonist and Bicalutamide|3-month treatment with an LHRH agonist chosen by the treating radiation oncologist and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
16269807|NCT00866554|Drug|administration of Bicalutamide, Dutasteride and Tamoxifen|"Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure.
~Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride
~Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered."
16269808|NCT00866541|Device|artificial increased resistance (flow proportional pressure support)|respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator
16269809|NCT00866528|Drug|pazopanib|oral pazopanib once daily (Phase I starting dose 800 mg)
16269810|NCT00866528|Drug|paclitaxel|paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).
16269811|NCT00866515|Drug|Ketoconazole + GW642444M|Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5
16269812|NCT00866515|Drug|Placebo + GW642444M|Placebo to match D1-6 + GW642444M 25ug single dose on D5
16269813|NCT00866502|Drug|sNN0031|Continuous ICV infusion for two weeks
16269814|NCT00866502|Drug|Placebo|Continous ICV infusion
16269815|NCT00866489|Procedure|remote preconditioning|Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated.
16269816|NCT00866476|Biological|CVD 1208S, a Shigella flexneri 2a live, oral vaccine|CVD 1208S consists of freshly harvested ∆guaBA, ∆sen, ∆set S. flexneri 2a strain 2457T suspended in phosphate buffered saline to reach the desired inoculum Form: liquid Dose: 10 to the 9th power CFU in 1.0 ml Route: oral.
16269817|NCT00866476|Other|Placebo|30 ml of buffer solution (2.0 grams of NaHCO3 dissolved in 150 ml of sterile water) without bacteria, to which food grade corn starch, USP is added, as necessary, to match the turbidity of the vaccine inoculum
16269818|NCT00866463|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Oral Tablet With Water
16269819|NCT00866463|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Experimental Tablet With Water
16269820|NCT00866463|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
16269821|NCT00866450|Dietary Supplement|Western style diet (high fat and low in calcium)|Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days
16269822|NCT00866450|Dietary Supplement|Prudent-style diet (low fat and high in calcium)|Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days
16269823|NCT00866437|Drug|Skin test panel|"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
~Hormones:
~Progesterone 1mmol/L
~Estradiol 1mmol/L
~Estrone 3mmol/L
~Estriol 3mmol/l
~Controls:
~Saline (NaCl) 0.9%
~Ethyl Oleate with 10% Benzyl Alcohol
~Histamine phosphate 1mg/ml (epicutaneous- prick test)"
16269824|NCT00866437|Drug|Skin test panel|"Hormones:
~Progesterone 1mmol/L
~Estradiol 1 mmol/L
~Estrone 3 mmol/L
~Estriol 3mmol/l
~Controls:
~Saline (NaCl) 0.9%
~Ethyl Oleate with 10% Benzyl Alcohol
~Histamine phosphate 1mg/ml (epicutaneous- prick test)"
16269825|NCT00866424|Procedure|Hyperbaric oxygen, Mock hyperbaric chamber|"Hyperbaric oxygen treatment for 10 days in treatment groups and mock hyperbaric chamber treatment for 10 days in control groups.
~Hyperbaric oxygen treatment: While in the hyperbaric chamber the subjects breathe 100% oxygen saturation with mask at 2.0bars.
~Mock hyperbaric chamber treatment: The subjects breathe air freely in the imitation environment chamber at 1.0bars."
16269826|NCT00866411|Procedure|cranial electrotherapy stimulation (CES) with Alpha-Stim|three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)
16269827|NCT00866411|Procedure|placebo|three weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo
16269828|NCT00866385|Drug|AZD8566|Single 6 mg oral solution dose
16269829|NCT00866385|Drug|AZD8566 IV carbon labelled|Single 10 mcg intravenous carbon-14 microtracer dose
16269915|NCT00865748|Drug|Metformin HCl 500 mg tablets, single dose|A: Experimental Subjects received Alpharma formulated products under fasting conditions
16269830|NCT00866359|Drug|Apremilast (CC-10004)|"Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.
~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.
~Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)"
16269831|NCT00866359|Drug|Placebo|"Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.
~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.
~Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)"
16269832|NCT00866346|Biological|PR1-primed lymphocyte (PR1-CTL) Infusion|"Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart.
~Starting infusion dose 1 x 106 nucleated cells/kg."
16269833|NCT00866333|Drug|Entinostat|Entinostat tablets
16269834|NCT00866320|Drug|sorafenib tosylate|Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.
16269835|NCT00866307|Drug|Cyclophosphamide|Given IV
16269836|NCT00866307|Drug|Cytarabine|Given IT and IV or SC
16269837|NCT00866307|Drug|Daunorubicin Hydrochloride|Given IV
16269838|NCT00866307|Drug|Dexamethasone|Given IV
16269839|NCT00866307|Drug|Doxorubicin Hydrochloride|Given IV
16269840|NCT00866307|Other|Laboratory Biomarker Analysis|Correlative studies
16269841|NCT00866307|Drug|Mercaptopurine|Given PO
16269842|NCT00866307|Drug|Methotrexate|Given IT and PO
16269843|NCT00866307|Drug|Pegaspargase|Given IV
16269844|NCT00866307|Drug|Prednisone|Given IV or PO
16269845|NCT00866307|Radiation|Prophylactic Cranial Irradiation|Undergo radiation
16269846|NCT00866307|Drug|Thioguanine|Given PO
16269847|NCT00866307|Drug|Vincristine Sulfate|Given IV
16269848|NCT00866294|Drug|paroxetine IR 10mg tablet|1 or 2 tablets once a day
16269849|NCT00866294|Drug|paroxetine IR 20mg tablet|1 tablet once a day
16269850|NCT00866294|Drug|matched placebo to paroxetine IR 10mg or 20mg|1 or 2 tablets once a day
16269851|NCT00866294|Drug|Paroxetine CR 12.5mg tablet|1 or 2 tablets once a day
16269852|NCT00866294|Drug|Paroxetine CR 25mg tablet|1 or 2 tablets once a day
16269853|NCT00866294|Drug|matched placebo to paroxetine CR 12.5mg or 25mg|1 or 2 tablets once a day
16269854|NCT00866281|Drug|midostaurin|Midostaurin 25 mg/mL oral solution was provided in bottles of 50 mL, administered with water. The pediatric starting dose of midostaurin was set at 30 mg/m2 bid and was not to exceed 60 mg/m2 bid.
16269855|NCT00866268|Device|low pressure suction drainage|In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter. Duration: Drains were removed after bleeding had ceased (48-72h).
16269856|NCT00866268|Device|High pressure suction drainage|In order to mask the type of intervention from the patient and the investigators, both drainage systems had two drain catheters. One catheter allowed the blood to flow from the wound to the bottle. The second catheter connected the bottle to the vacuum source. In the experimental arm the second catheter was open, while in the control group it was closed. So that the system used could not be distinguished, the connection of the second catheter to the bottle was covered with opaque adhesive tape.Drains were removed after bleeding had ceased.
16269857|NCT00866255|Device|endotracheal tube pressure measurement probe|The endotracheal tube pressure measurement probe is inserted into the endotracheal tube prior to intubation for measurement of tracheal pressure at the tip of the endotracheal tube.
16269858|NCT00866242|Biological|CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a|The challenge strain consists of freshly harvested Shigella flexneri 2a strain 2457T diluted in phosphate buffered saline to reach the desired inoculum Form: liquid Dose 10 to the 3rd power CFU in 1.0 ml Route: oral.
16269859|NCT00866229|Drug|Rosuvastatin|10 mg per day for 12 weeks
16269860|NCT00866229|Drug|Simvastatin|20 mg per day
16269861|NCT00866216|Drug|Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals|
16269862|NCT00866216|Drug|Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.|
16269863|NCT00866203|Drug|HDS vs ProMECE/CytaBOM|
16269864|NCT00866190|Drug|SQ109|SQ109 150 mg is an oval, coated, white, scored tablet. Dosages: 75 mg administered once daily for 14 days; 150 mg administered once daily on Days 1-5, 9, and 14; and 150 mg administered once daily for 14 days.
16269865|NCT00866190|Drug|Placebo|Placebo is an oval, coated, white, scored tablet administered once daily for 14 days or on Days 1-5, 9, and 14.
16269866|NCT00866177|Other|Laboratory Biomarker Analysis|Correlative studies
16269867|NCT00866177|Drug|Selumetinib|Given orally
16269868|NCT00866164|Device|Prometra Programmable Pump|Implantation of Prometra Pump for delivery of intrathecal morphine for the treatment of chronic intractable pain
16269869|NCT00866138|Drug|masitinib (AB1010)|masitinib 9 mg/kg/day per os
16269870|NCT00866112|Other|Educational session to promote physical activity|Educational session, goal setting, self monitoring of daily engagement in physical activity
16269871|NCT00866112|Other|Minimal contact|Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity
16269914|NCT00865761|Drug|XANAX XR® 3 mg tablets, single dose|B: Active comparator Subjects received Pharmacia & Upjohn Company formulated products under fasting conditions
16270332|NCT00862888|Drug|PF-00446687|Single 175 mg dose as an oral solution
16269872|NCT00866099|Other|Educational Dementia training|"Tailored learning activities on dementia, over a three-month period and will be given an electronic training manual (based on Microsoft packages) which they can run in the background during and after consultations with people with known or suspected dementia syndrome and face-to- face individualised workshop sessions.
~Tailoring of the education programme is carried out in a three step process: 1) an educational needs analysis is carried our using a standard checklist to identify aspects of dementia care which the practice perceives as problematic for them; 2) a prescription for education is then written to address shortcomings; 3) the best forms of learning are then identified."
16269873|NCT00866086|Other|questionnaire administration|
16269874|NCT00866086|Procedure|computed tomography|
16269875|NCT00866086|Radiation|radiation therapy treatment planning/simulation|
16269876|NCT00866073|Drug|Decitabine 15 mg/m2 i.v.|Decitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days
16269877|NCT00866060|Drug|Memantine|20mg memantine
16269878|NCT00866060|Drug|Donepezil|10mg donepezil
16269879|NCT00866060|Drug|Placebo donepezil|Placebo donepezil
16269880|NCT00866060|Drug|Placebo memantine|Placebo memantine
16269881|NCT00866047|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by IV infusion
16269882|NCT00866034|Drug|Cetrotide (Ovarian stimulation)|Fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2
16269883|NCT00866034|Drug|Cetrotide (Ovarian stimulation)|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6.
16269884|NCT00866021|Drug|Lopinavir/ritonavir|NRTI sparing-regimen
16269885|NCT00866021|Drug|Lopinavir/ritonavir with two nucleoside analogs|LPV/r plus 2NRTIs + PEG-INF + RBV
16269886|NCT00866008|Drug|Ovarian stimulation|"Conventional regimen with a daily dose of 225 IU recombinant FSH and GnRH agonist long protocol co-treatment
~Mild ovarian stimulation regimen using the endogenous FSH production by starting treatment on day 5 of the menstrual cycle with 150 IU / d recFSH with GnRH antagonist co treatment starting on day 6. As soon as two follicles reach 12 mm, treatment is continued with 200 IU / d rec hCG."
16269887|NCT00865995|Procedure|Tracheal Lavage|Tracheal Lavage will be performed on the control population patients and the tracheal fluid obtained from this procedure will be used as the research sample.
16269888|NCT00865982|Drug|Docetaxel, Cisplatin, Capecitabine|"3 preoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks
~followed by resection
~and 3 postoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks."
16269890|NCT00865956|Behavioral|Contingency Management|Rite Aid vouchers (stepped value) for reinforcement of adherence to primary care
16269891|NCT00865956|Other|Case management|Nurse case manager assigned to participant
16269892|NCT00865943|Drug|Citalopram HBr eq. 10 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16269893|NCT00865943|Drug|CELEXATM 10 mg tablets, single dose|B: Active comparator Subjects received Forest Pharmaceuticals, Inc. marketed products under fasting conditions
16269894|NCT00865917|Drug|beta-blocker (Metoprolol)|Metoprolol 95 mg once per day
16269895|NCT00865917|Drug|I(f)-blocker (ivabradine)|ivabradine 7.5 mg once per day
16269896|NCT00865917|Drug|Placebo|matching appearance
16269897|NCT00865904|Drug|VX-809|Capsules
16269898|NCT00865904|Drug|Placebo|Placebo matched to VX-809 capsules.
16269899|NCT00865891|Drug|Nifedipine Extended Release tablets 60 mg, single dose|A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under fasting conditions
16269900|NCT00865891|Drug|ADALAT® CC Extended Release Tablets 60 mg|B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under fasting conditions
16269901|NCT00865878|Drug|Aminolevulinic Acid|20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
16269902|NCT00865878|Other|Vehicle|Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
16269903|NCT00865865|Procedure|Computer aided total knee arthroplasty|Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
16269904|NCT00865865|Procedure|Conventional total knee arthroplasty|Conventional method of total knee arthroplasty
16269905|NCT00865852|Drug|Metformin HCl 750 mg Extender Release tablets, single dose|A: Experimental Subjects received Purepac formulated products under non-fasting conditions
16269906|NCT00865852|Drug|GLUCOPHAGE® XR 750 mg tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions
16269907|NCT00865839|Drug|Metformin HCl 500 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16269908|NCT00865839|Drug|CLUCOPHAGE® XR 500 mg tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
16269909|NCT00865826|Other|Standardized diagnostic evaluation|Participants will undergo a diagnostic evaluation for TB at study entry
16269910|NCT00865813|Procedure|Punch Biopsy|"Instillation of anesthetic eye drops.
~Asepsis
~Placement of surgical cloths and drapes
~Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution.
~Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions
~Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade"
16269911|NCT00865774|Behavioral|Quantity Frequency Model|The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.
16269912|NCT00865774|Behavioral|Targets Subjective Drunkenness|Explores factors leading to drunkenness and alternative coping strategies for healthier function.
16269913|NCT00865761|Drug|Alprazolam 3 mg Extended Release Tablets, single dose|A: Experimental Subjects received Alpharma formulated products under fasting conditions
16269916|NCT00865748|Drug|CLUCOPHAGE® XR 500 mg tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
16269917|NCT00865722|Procedure|Remote Postconditioning|Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
16269918|NCT00865709|Drug|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
16269919|NCT00865709|Drug|Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
16269920|NCT00865696|Drug|Mirtazapine 15 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16269921|NCT00865696|Drug|REMERON® 15 mg tablets, single dose|B: Active comparator Subjects received Organon Inc. formulated products under fasting conditions
16269922|NCT00865683|Dietary Supplement|DHA Supplements|Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
16269923|NCT00865683|Dietary Supplement|Placebo Supplements|Participants will receive placebo supplements each day for approximately 3 months (until they give birth).
16269924|NCT00865670|Drug|Azithromycin Monohydrate 600 mg Tablets|
16269925|NCT00865670|Drug|Zithromax (azithromycin dihydrate) 600 mg Tablets|
16269926|NCT00865657|Drug|Alprazolam 3 mg Extended Release Tablets, single dose|A: Experimental Subjects received Alpharma formulated products under non-fasting conditions
16269927|NCT00865657|Drug|XANAX XR® 3 mg tablets, single dose|B: Active comparator Subjects received Pharmacia & Upjohn Company formulated products under non-fasting conditions
16269928|NCT00865644|Drug|Imiquimod 5% Cream|Applied topically to three tumors 5 times per week for a full 6 weeks
16269929|NCT00865631|Drug|Gabapentin 800 mg tablets, single dose (1 tablet)|A: Experimental Subjects received Purepac formulated products under fasting conditions
16269930|NCT00865631|Drug|NEURONTIN® 400 mg capsules, single dose (2 capsules)|B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions
16269931|NCT00865631|Drug|Gabapentin 800 mg tablets, single dose (1 tablet)|A: Experimental Subjects received Purepac formulated products under non-fasting conditions
16269932|NCT00865618|Drug|Eplerenone 50 mg Tablets Sandoz Inc., USA|
16269933|NCT00865618|Drug|Inspra 50 mg Tablets GD Searle LLC, USA|
16269934|NCT00865605|Drug|Halobetasol Propionate 0.05% Ointment, single exposure|A: Other Subjects received Alpharma/Purepac USHP formulated products
16269935|NCT00865605|Drug|Ultravate® 0.05% ointment, single exposure|Subjects received Bristol-Myers Squibb Company formulated products
16269936|NCT00865592|Drug|dutogliptin|dutogliptin 400 mg, once daily tablet
16269937|NCT00865579|Drug|Safinamide|"The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm).
~Trial Medication is to be taken once daily, in the morning."
16269938|NCT00865566|Biological|DNA plasmid vaccine|4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
16269939|NCT00865566|Biological|Recombinant adenoviral serotype 5 (rAD5) vector vaccine|1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
16269940|NCT00865566|Biological|DNA vaccine placebo|1 mL IM via Biojector® in either deltoid
16269941|NCT00865566|Biological|HIV-1 recombinant adenovirus vaccine placebo|1 mL administered IM by needle and syringe in either deltoid
16269942|NCT00865553|Behavioral|computer-assisted smoking cessation intervention|
16269943|NCT00865553|Other|cancer prevention|
16269944|NCT00865553|Other|educational intervention|
16269945|NCT00865553|Other|survey administration|
16269946|NCT00865540|Drug|prednisolone acetate 1%|1 drop every 8h two days before surgery
16269947|NCT00865540|Drug|ketorolac tromethamine 0.4%|1 drop every 8h two days before surgery
16269948|NCT00865540|Drug|nepafenac 0.1%|1 drop every 8h two days before surgery
16269949|NCT00865540|Drug|methylcellulose 0.5%|1 drop every 8h two days before surgery
16269950|NCT00865527|Other|Fecal occult blood test|FOBT
16269951|NCT00865527|Procedure|Virtual colonoscopy|computed tomographic colonography
16269952|NCT00865527|Procedure|Optical colonoscopy|optical (conventional / endoscopic) colonoscopy
16269953|NCT00865514|Drug|Dichloroacetate|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
16269954|NCT00865514|Genetic|Genotyping|Subjects will have 5 mls of blood drawn for genotyping
16269955|NCT00865514|Other|Leucine|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
16269956|NCT00865514|Other|tyrosine|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
16269957|NCT00865501|Drug|spironolactone|25mg per oral once daily
16269958|NCT00865501|Drug|placebo|placebo
16269959|NCT00865488|Biological|ADHEXIL|Adhesions prevention
16270333|NCT00862888|Drug|PF-00446687|Single 20 mg dose as an oral solution
16269960|NCT00865475|Drug|AZT+3TC+ABV (Trizivir)|Patients on treatment with TZV and viral suppression will be randomized to keep on TZV vs switching to LPV/r monotherapy
16269961|NCT00865475|Drug|Switching to LPV/r monotherapy (Kaletra)|Patients on AZT+3TC+ABV with viral suppression will be randomized to keep on vs switching to LPV/r
16269962|NCT00865462|Drug|Abrika Bupropion 150 mg XL Tablet, single dose|A: Experimental Subjects received Abrika formulated products under fed conditions
16269963|NCT00865462|Drug|Wellbutrin XL® 150 mg Tablet, single dose|B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
16269964|NCT00865449|Drug|spironolactone|25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
16269965|NCT00865449|Drug|Placebo|Placebo, given daily for 6 months to Peritoneal Dialysis Patients
16269966|NCT00865436|Drug|Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg|A: Experimental Subjects received Alpharma formulated products under fasting conditions
16269967|NCT00865436|Drug|CLUCOVANCE® 5 mg/500 mg Tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
16269968|NCT00865423|Drug|Gabapentin 800 mg Tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16269969|NCT00865423|Drug|NEURONTIN® 800 mg Tablets, single dose|B: Active comparator Subjects received Parke-Davis formulated products under fasting conditions
16269970|NCT00865410|Drug|Abrika Bupropion 150 mg Extended-Released Tablet|A: Experimental Subjects received Abrika formulated products under fasting conditions
16269971|NCT00865410|Drug|Wellbutrin SR® 150 mg Extended-Release Tablet, single dose|B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
16269972|NCT00865397|Drug|insulin detemir|Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
16269973|NCT00865384|Drug|Mirtazapine 15 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under non-fasting conditions
16269974|NCT00865384|Drug|REMERON® 15 mg tablets, single dose|B: Active comparator Subjects received Organon Inc. formulated products under non-fasting conditions
16269975|NCT00865371|Drug|Abrika Bupropion 150 mg Extended-Released Tablet|A: Experimental Subjects received Abrika formulated products under fed conditions
16269976|NCT00865371|Drug|Wellbutrin SR® 150 mg Extended-Release Tablet, single dose|B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
16269977|NCT00865358|Behavioral|Yoga Group|Reproducible standardized 12 week series of hatha yoga classes specifically developed for patients with chronic low back pain and little or no experience with yoga
16269978|NCT00865345|Device|MMT-7003 subcutaneous glucose sensor|All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.
16269979|NCT00865319|Radiation|Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)|one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG to be injected
16269980|NCT00865319|Radiation|18 F fluorodeoxyglucose|single injection of 18F FDG (range 10-20mCi)
16269981|NCT00865306|Behavioral|"Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."|"This is a cognitive-behavioral intervention modeled loosely after Kendall's Coping Cat, which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments."
16269982|NCT00865280|Drug|PTK 0796|PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg
16269983|NCT00865280|Drug|linezolid|For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
16269984|NCT00865280|Drug|moxifloxacin|moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution
16269985|NCT00865267|Drug|Ultravate® 0.05% ointment, single exposure|A: Experimental Subjects received Bristol-Myers Squibb Company formulated products
16269986|NCT00865254|Behavioral|Standard Treatment|Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
16269987|NCT00865254|Behavioral|Traditional Contingency Management|Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking. Prize draws result in incentives on an intermittent schedule (50% of draws are prizes). Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
16269988|NCT00865254|Behavioral|Early Enhanced Contingency Management|Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking. Prize draws result in incentives on an intermittent schedule (100% of draws are prizes in week 1; 33% are prizes in weeks 2-4). Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
16269989|NCT00865241|Drug|Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg|A: Experimental Subjects received Alpharma formulated products under fasting conditions
16269990|NCT00865241|Drug|CLUCOVANCE® 5 mg/500 mg Tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
16269991|NCT00865228|Drug|Lapaquistat acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
16269992|NCT00865228|Drug|Lapaquistat acetate|Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
16269993|NCT00865228|Drug|Lapaquistat acetate|Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
16270334|NCT00862888|Drug|Placebo|Placebo for oral solution
16269994|NCT00865228|Drug|Placebo|Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
16269995|NCT00865215|Drug|Propranolol Hydrochloride Extended Release Capsules 160 mg|A: Experimental Subjects received Actavis formulated products under fasting conditions
16269996|NCT00865215|Drug|INDERAL® LA 160 mg Capsules, single dose|B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions
16269997|NCT00865202|Drug|L-tryptophan supplementation|L-tryptophan 1 gram enterally TID for a maximum of nine doses or to be discontinued at the time of discharge from the ICU (whichever occurs first)
16269998|NCT00865202|Drug|placebo|Similar appearing placebo administered post-operatively (1 enterally TID) for a total of nine doses or discharge from ICU (whichever occurs first)
16269999|NCT00865189|Drug|Bevacizumab|Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
16270000|NCT00865189|Drug|Oxaliplatin|Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.
16270001|NCT00865189|Drug|Folinic Acid|Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.
16270002|NCT00865189|Drug|5-fluorouracil|5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
16270003|NCT00865189|Radiation|Preoperative Radiotherapy|Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
16270004|NCT00865189|Procedure|Surgery|Radical rectal excision based on the TME technique.
16270005|NCT00865176|Drug|Eplerenone 50 mg Tablets Sandoz Inc., USA|
16270006|NCT00865176|Drug|Inspra 50 mg Tablets GD Searle LLC, USA|
16270007|NCT00865137|Drug|Tacrolimus, modified release|Oral
16270008|NCT00865124|Drug|Spironolactone|25 mg capsule daily for 6 months
16270009|NCT00865124|Drug|Hydrochlorothiazide + potassium|hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
16270010|NCT00865124|Other|Placebo|Placebo capsule daily
16270011|NCT00865111|Drug|Bupropion 150 mg Extended-Released Tablet, single dose|A: Experimental Subjects received Abrika formulated products under fasting conditions
16270012|NCT00865111|Drug|Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose|B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
16270013|NCT00865098|Drug|Cetuximab|Patients receive Cetuximab at an initial dose of 400 mg/m^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of Cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.
16270014|NCT00865085|Drug|Citalopram HBr 40 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16270015|NCT00865085|Drug|CelexaTM 40 mg tablets, single dose|B: Active comparator Subjects received Forest Labs formulated products under fasting conditions
16270016|NCT00865072|Drug|Metformin HCl 750 mg Extender Release tablets, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16270017|NCT00865072|Drug|GLUCOPHAGE® XR 750 mg tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
16270018|NCT00865059|Drug|Gabapentin 800 mg Tablets, single dose|A: Experimental Subjects received Purepac formulated products under non-fasting conditions
16270019|NCT00865059|Drug|NEURONTIN® 800 mg Tablets, single dose|B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions
16270020|NCT00865046|Other|Periosteal stimulation|Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
16270021|NCT00865046|Other|Control-Periosteal Stimulation|Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
16270022|NCT00865033|Drug|Metformin HCL Tablets, 1000 mg Sandoz|
16270023|NCT00865033|Drug|Glucophage 1000 mg|
16270024|NCT00865020|Drug|Aliskiren|Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.
16270025|NCT00865020|Drug|Telmisartan|Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.
16270026|NCT00865020|Drug|Placebo to Aliskiren|Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.
16270027|NCT00865020|Drug|Placebo to Telmisartan|Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.
16270028|NCT00865007|Drug|Monotherapy (Lopinavir/ritonavir)|NRTI sparing
16270029|NCT00865007|Drug|Monotherapy (Lopinavir/ritonavir) + ABC/3TC|NRTI sparing regimen
16270030|NCT00864981|Drug|Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.|
16270031|NCT00864981|Drug|WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline|
16270032|NCT00864968|Drug|Nabumetone 750 mg tablets, single dose|A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fasting conditions
16270033|NCT00864968|Drug|Nabumetone 750 mg tablets, single dose|B: Active comparator Subjects received Teva formulated products under fasting conditions
16270034|NCT00864955|Radiation|UVA and UVB irradiation|"4 cutaneous biopsies for Ex-vivo irradiation
~Determination of the minimal erythemic dose of UVA and UVB for each volunteer"
16270075|NCT00864643|Drug|Atorvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
16270335|NCT00862888|Drug|Placebo|Placebo for tablet
16270336|NCT00862888|Drug|Sildenafil|Single oral dose 100 mg tablet
16270035|NCT00864942|Drug|bendamustine and lenalidomide|Lenalidomide is given daily orally for one week followed by bendamustine HCL 90 mg/m2 IV over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.
16270036|NCT00864942|Drug|BL-NHL|Bendamustine HCL 90 mg/m2 given intravenously over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.
16270037|NCT00864942|Drug|BLR-CLL|Lenalidomide is given orally for 7 days followed by rituximab 375 mg/m2 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.
16270038|NCT00864942|Drug|BLR-NHL|Rituximab 375 mg/m2 is given on day 1 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.
16270039|NCT00864916|Drug|Combination antiretroviral therapy (cART)|Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)
16270040|NCT00864916|Drug|Pentoxifylline|Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.
16270041|NCT00864916|Drug|Placebo|Participants will receive placebo three times per day for 48 weeks.
16270042|NCT00864890|Drug|Citalopram HBr 40 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under fed conditions
16270043|NCT00864890|Drug|CelexaTM 40 mg tablets, single dose|B: Active comparator Subjects received Forest Labs formulated products under fed conditions
16270044|NCT00864877|Device|biodegradable fixation system (Inion OTPS FreedomPlateTM)|
16270045|NCT00864864|Drug|Sunitinib|Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period
16270046|NCT00864851|Biological|Replagal|Intravenous (IV) infusion for 12 months
16270047|NCT00864838|Drug|Acetazolamide|250 mg 1 hour before intravitreal injection
16270048|NCT00864838|Drug|Brimonidine tartarate|1 drop 1 hour before intravitreal injection
16270049|NCT00864838|Procedure|Anterior chamber paracentesis|Immediately after bevacizumab injection
16270050|NCT00864825|Drug|Allopurinol|Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
16270051|NCT00864812|Drug|tiotropium with fluticasone propionate/salmeterol (FSC)|COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
16270052|NCT00864812|Drug|tiotropium|COPD patients treated with tiotropium
16270053|NCT00864799|Drug|Misoprostol|Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
16270054|NCT00864786|Drug|PF03635659|Inhaled doses of 200 mcgQD
16270055|NCT00864786|Drug|PF03635659|Inhaled doses of 600 mcg QD
16270056|NCT00864786|Drug|PF03635659|Inhaled doses of 1000 mcg QD
16270057|NCT00864786|Drug|PF03635659|Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.
16270058|NCT00864786|Drug|PF03635659|Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.
16270059|NCT00864773|Procedure|intravitreal injection with anterior paracentesis|0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)
16270060|NCT00864760|Drug|Gabapentin 800 mg tablets, single dose (1 tablet)|A: Experimental Subjects received Purepac formulated products under fasting conditions
16270061|NCT00864760|Drug|NEURONTIN® 400 mg capsules, single dose (2 capsules)|B: Active comparator Subjects received Parke-Davis formulated products under fasting conditions
16270062|NCT00864747|Drug|Propranolol Hydrochloride Extended Release Capsules 160 mg|A: Experimental Subjects received Actavis formulated products under non-fasting conditions
16270063|NCT00864747|Drug|INDERAL® LA 160 mg Capsules, single dose|B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products non-under fasting conditions
16270064|NCT00864734|Drug|Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg|A: Experimental Subjects received Alpharma formulated products under non-fasting conditions
16270065|NCT00864734|Drug|CLUCOVANCE® 5 mg/500 mg Tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions
16270066|NCT00864721|Drug|Sutent|Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
16270067|NCT00864708|Device|radio frequency-controlled (RF) Microstimulator (RFM) Gait System|Fully Implanted FES system to assist patient with gait component practice
16270068|NCT00864695|Other|Supportive care|protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.
16270069|NCT00864682|Drug|Saline|3.3 mL normal saline
16270070|NCT00864682|Drug|Lidocaine / propofol admixture|lidocaine 50 mg plus propofol 50 mg intravenous (iv)
16270071|NCT00864682|Drug|lidocaine pretreatment|lidocaine 50 mg iv under tourniquet-control
16270072|NCT00864669|Drug|Metformin HCl 500 mg tablets, single dose|A: Experimental Subjects received Purepac formulated products under non-fasting conditions
16270073|NCT00864669|Drug|CLUCOPHAGE® XR 500 mg tablets, single dose|B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions
16270074|NCT00864643|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
16270076|NCT00864630|Behavioral|Computer-based problem solving therapy|Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.
16270077|NCT00864617|Drug|Nifedipine Extended Release tablets 60 mg, single dose|A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under non-fasting conditions
16270078|NCT00864617|Drug|ADALAT® CC Extended Release Tablets 60 mg|B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under non-fasting conditions
16270079|NCT00864604|Drug|Nabumetone 750 mg tablets, single dose|A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fed conditions
16270080|NCT00864604|Drug|Nabumetone 750 mg tablets, single dose|B: Active comparator Subjects received Teva formulated products under fed conditions
16270081|NCT00864591|Procedure|SPECT Imaging|Myocardial SPECT imaging will be performed 10-12 minutes after the stress injection of Tl-201, at 4 hours, and at 18-24 hours in patients with non-reversible or partially reversible defect on 4-hour imaging. Images will be obtained with a rotating single- or dual-head gamma camera equipped with low-energy high resolution collimators. Energy windows of 20% and 10% will be centered on the 70 KeV and 167 KeV peaks of Tl-201, respectively. Thirty images will be obtained (40 seconds each for the stress and 4-hour redistribution imaging, and 60 seconds each for the 18-24-hour imaging) over 180° extending from the 45° right anterior oblique to the 45° left posterior oblique projections.Localization of the disease in the left anterior descending artery (LAD), left circumflex (Cx) and right coronary artery (RCA) will be performed using a quantitative analysis software.
16270082|NCT00864591|Procedure|Stress Adenosine CMR|"CMR will be performed using a 3-T scanner and a dedicated eight-element cardiac phased-array coil Cine CMR will be performed using steady state free precession in the short-axis, two chamber, three chamber and four-chamber, 8 mm thick, separated by 0-mm gaps.
~Adenosine perfusion CMR: Adenosine will be administered intravenously at 140 µg/kg/min over 6 min. Four minutes into the infusion (or earlier if angina is provoked), a bolus (0.1 mmol/kg at 5 ml/s) of Gadolinium DTPA will be administered. Patients will be instructed to hold their breath. Stress perfusion images will be acquired in the short axis plane (parameters and planning will be similar for stress and rest perfusion evaluation). The patients will be monitored by vector ECG, noninvasive sphygmomanometry, pulse oximetry and capnography."
16270083|NCT00864565|Drug|Fentanyl 25 μg/h transdermal system, single application|A: Experimental Subjects received Corium International, Inc formulated products
16270084|NCT00864565|Drug|Duragesic 25 μg/h transdermal system single application|B: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products
16270085|NCT00864552|Drug|Kogenate (BAY14-2222)|Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
16270086|NCT00864539|Dietary Supplement|fortified milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks
16270087|NCT00864539|Dietary Supplement|plain milk|daily intake of 200 ml plain milk
16270088|NCT00864539|Dietary Supplement|fortified orange juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package
16270089|NCT00864539|Dietary Supplement|plain orange juice|daily intake of 250 ml plain orange juice
16270090|NCT00864539|Dietary Supplement|calcium-vitamin D supplement|daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)
16270091|NCT00864539|Dietary Supplement|Placebo|daily placebo
16270092|NCT00864526|Drug|Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose|A: Experimental SSubjects received Actavis formulated products under fasting conditions
16270093|NCT00864526|Drug|COMBONOX® tablets, single dose|B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under fasting conditions
16270094|NCT00864513|Drug|pemetrexed|pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
16270095|NCT00864500|Drug|Clobetasol Propionate 0.05% lotion, single exposure|A: Experimental Subjects received Alpharma USPD, Inc formulated products
16270096|NCT00864500|Drug|Clobex TM 0.05% Lotion, single exposure|B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
16270097|NCT00864487|Drug|Neratinib|HKI-272
16270098|NCT00864474|Drug|CELSENTRI® Tablets|"CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food."
16270099|NCT00864448|Drug|Ramipril10 mg Capsules, single dose|A: Experimental Subjects received Purepac formulated products under fasting conditions
16270100|NCT00864448|Drug|Atlace® 10 mg capsules, single dose|B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fasting conditions
16270101|NCT00864435|Drug|Carvedilol 12.5 mg Tablets, single dose|A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fasting conditions
16270102|NCT00864435|Drug|Coreg® 12.5 mg Tablets , single dose|B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fasting conditions
16270103|NCT00864422|Behavioral|Skilled motor training|This involves training subjects to independently and cognitively activate the deep abdominal muscles, transversus abdominis, with minimal or no activity in other trunk muscles. The contraction is held for 10 seconds and subjects complete three blocks of ten contractions, twice per day for two weeks. This training protocol is commonly used clinically for people with chronic back pain.
16270104|NCT00864422|Behavioral|Walking exercise|The control intervention involves walking exercises for ten minutes, twice per day. Subjects are advised to walk at their own pace with no instructions on activation of specific trunk muscles. The exercise is performed over two weeks.
16270105|NCT00864409|Drug|ropivacaine 0,2%|Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL
16270106|NCT00864409|Drug|saline.9%|Wound infiltration with 170 mL sterile saline
16270107|NCT00864396|Drug|Prevacid|30mg of Lansoprazole twice daily (or placebo)for eight weeks.
16270146|NCT00864175|Drug|trastuzumab|trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
16270147|NCT00864175|Drug|Docetaxel|
16270108|NCT00864383|Drug|Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin|"Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg
~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
16270109|NCT00864357|Drug|Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose|A: Experimental SSubjects received Actavis formulated products under non-fasting conditions
16270110|NCT00864357|Drug|COMBONOX® tablets, single dose|B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under non-fasting conditions
16270111|NCT00864344|Drug|Sertraline HCl 100 mg tablets, single dose|A: Experimental SSubjects received Purepac formulated products under fasting conditions
16270112|NCT00864344|Drug|Zoloft® 100 mg tablets, single dose|B: Active comparator Subjects received Pfizer formulated products under fasting conditions
16270113|NCT00864331|Radiation|radiation|39 Gy in 13 daily fractions of 3 Gy
16270114|NCT00864331|Other|Chemotherapy and radiotherapy|Chemotherapy followed by low dose palliative radiotherapy
16270115|NCT00864331|Drug|Chemotherapy|Chemotherapy given alone
16270116|NCT00864331|Other|Palliative radiotherapy and chemotherapy|Low dose palliative radiotherapy followed by chemotherapy
16270117|NCT00864318|Drug|Paclitaxel|200mg/m2 for 3 hours at Cycle 1 day 1 and Cycle 2 day 1 with 14 days between cycles
16270118|NCT00864318|Drug|Ifosfamide|2g/m²/day in 1 liter of G5 for 3 hours at Cycle 1 and Cycle 2 from day 2 to day 4 with 14 days between cycles
16270119|NCT00864318|Drug|Carboplatine|"From cycle 3 to cycle 5 :
~Carboplatine is administered with AUC = 24 mg/mL x min from Day 1 to Day 3. Day 3 Carboplatine dose is calculated taking into account real creatinine clearance defined at day 1 for each patient"
16270120|NCT00864318|Drug|Etoposide|From Cycle 3 to cycle 5, 400mg/m2/day from day 1 to day 3
16270121|NCT00864318|Procedure|cytapheresis + transfusion of autologous peripheral blood stem cells|"Cytapheresis occured between day 11 and day 13 of the 2 first cycle (Taxol® +Holoxan®). Cytapheresis total objective is 9X106 CD34+/kg of patient weight.
~At cycle 3, 4 and 5 at day 5 : Re-injection of stem cells (1/3 with minimum 2.106 CD34/kg) 48 hours after chemotherapy end"
16270122|NCT00864305|Drug|Gabapentin 400 mg capsules|A: Experimental Subjects received Purepac formulated products under fed conditions
16270123|NCT00864305|Drug|NEURONTIN® 400 mg capsules|B: Active comparator Subjects received Parke-Davis's marketed product
16270124|NCT00864305|Drug|Gabapentin 400 mg capsules, single dose|C: Experimental Subjects received Purepac formulated products under fasting conditions
16270125|NCT00864279|Drug|Cetirizine Hydrochloride 10 mg tablets, single dose|A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fast conditions
16270126|NCT00864279|Drug|Zyrtec® 10 mg tablets, single dose|B: Active comparator Subjects received Pfizer Inc. formulated products under fast conditions
16270127|NCT00864266|Drug|Chemotherapy|Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)
16270128|NCT00864253|Drug|ABI-007|Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
16270129|NCT00864253|Drug|Dacarbazine|Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
16270130|NCT00864240|Drug|Clobex TM (Clobetasol) 0.05% Lotion, single exposure|Subjects received Galderma Laboratories, L.P. formulated products
16270131|NCT00864227|Biological|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation|"The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
~Fludarabine: 40 mg/m^2 intravenously (IV) on Days -6, -5, -4, -3, and -2
~Cyclophosphamide: 50 mg/kg IV on Day -6
~Total body irradiation: 200 centigray (cGy) on Day -1"
16270132|NCT00864227|Biological|GVHD prophylaxis|"GVHD prophylaxis regimen will consist of:
~Cyclosporine: beginning on Day -3 with the dose adjusted to maintain a level of 200-400 mg/mL
~MMF: 1 gram IV three times a day (TID) if greater than 50 kg, or 15 mg/kg IV TID if less than 50 kg beginning on Day -3; continued until Day 30 or 7 days after engraftment, whichever day is later
~Day 0 is the day of the infusion of the umbilical cord blood graft units, which will be obtained from partially HLA-matched unrelated donors.
~Beginning on Day 1, participants will receive G-CSF 5 mcg/kg/day until absolute neutrophil count (ANC) is greater than or equal to 2,000/mm^3 for three consecutive measurements, each on different days."
16270133|NCT00864214|Drug|bioidentical hormone (Biest)|Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
16270134|NCT00864214|Drug|bioidentical hormone (Biest)|Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
16270135|NCT00864214|Drug|bioidentical hormone (Biest)|Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg
16270136|NCT00864214|Drug|bioidentical hormone (Vivelle-Dot)|Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg
16270137|NCT00864201|Drug|bosentan|bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks
16270138|NCT00864188|Dietary Supplement|no bacterial strains|Glucono-Delta-Lactone acidified milk containing no bacterial strains
16270139|NCT00864188|Dietary Supplement|One probiotic strain - Lactobacillus paracasei NCC2461|Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
16270140|NCT00864188|Dietary Supplement|Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus|Fermented milk containing two standard yogurt bacterial strains.
16270141|NCT00864188|Dietary Supplement|Vit B2, B3, C and E, Beta Carotene and Oil|Fermented milk containing nutritional supplements
16270142|NCT00864175|Drug|INCB007839|100 mg BID
16270143|NCT00864175|Drug|INCB007839|200 mg BID
16270144|NCT00864175|Drug|INCB007839|300 mg BID
16270145|NCT00864175|Drug|INCB007839|300 mg BID
16270148|NCT00864162|Drug|Ramipril10 mg Capsules, single dose|A: Experimental Subjects received Purepac formulated products under fed conditions
16270149|NCT00864162|Drug|Atlace® 10 mg capsules, single dose|B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fed conditions
16270150|NCT00864149|Drug|Carvedilol 12.5 mg Tablets, single dose|A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions
16270151|NCT00864149|Drug|Coreg® 12.5 mg Tablets , single dose|B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fed conditions
16270152|NCT00864136|Drug|Levonorgestrel (Mirena, BAY86-5028)|Women using Mirena for treatment of menorrhagia
16270153|NCT00864136|Drug|Conventional medical treatment|Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
16270154|NCT00864136|Drug|Conventional medical treatment|Women using anti-fibrinolytic agent for treatment of menorrhagia
16270155|NCT00864123|Behavioral|Cognitive-behavioral therapy|All patients will receive 10 sessions of therapy over 8 weeks that is based on the protocol used in POTS (2004). Sessions 1-4 will be held twice weekly; thereafter sessions will be held on a weekly basis. This evidence-based E/RP intervention (POTS, 2004) includes psychoeducation, cognitive training, and exposure and response prevention. By design, this manual provides sufficient flexibility to accommodate the child's developmental needs and address maladaptive parent-child interactions (e.g., accommodation).
16270156|NCT00864123|Drug|D-cycloserine|D-cycloserine (Seromycin, 250 mg; Eli Lilly and Co, Indianapolis, Indiana) will be capsulated into 25mg with identical placebo capsules. Children weighing between 25-45kg will be given a dosage of 25mg (approximately 0.56-1.0 mg/kg/day). Children weighing between 46-80kg will be given a dosage of 50mg (approximately 0.63-1.08mg/kg/day). DCS or placebo will be given by parents 1 hour prior to psychotherapy sessions (before sessions 4-10 only) based on past success in patients with acrophobia (Ressler et al., 2004) and DCS absorption rates.
16270157|NCT00864123|Drug|Placebo pill|This intervention involves taking a placebo pill(s) that matches the d-cycloserine capsules in size, shape, weight, and taste. Placebo contains an no active medication.
16270158|NCT00864110|Radiation|Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)|one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20 mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG will be injected
16270159|NCT00864110|Radiation|Technetium 99m ethylenedicysteine-deoxyglucose|99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)
16270160|NCT00864110|Radiation|18 F fluorodeoxyglucose|single injection of 18F FDG (range 10-20 mCi)
16270161|NCT00864097|Biological|tanezumab|IV tanezumab 10 mg every 8 weeks (through Week 16)
16270162|NCT00864097|Drug|diclofenac|Oral diclofenac SR 75 mg BID for 32 weeks
16270163|NCT00864097|Biological|tanezumab|IV tanezumab 5 mg every 8 weeks (through Week 16)
16270164|NCT00864097|Drug|diclofenac|Oral diclofenac SR 75 mg BID for 32 weeks
16270165|NCT00864097|Biological|tanezumab|IV tanezumab 2.5 mg every 8 weeks (through Week 16)
16270166|NCT00864097|Drug|diclofenac|Oral diclofenac SR 75 mg BID for 32 weeks
16270167|NCT00864097|Drug|diclofenac|Oral diclofenac SR 75 mg BID for 32 weeks
16270168|NCT00864097|Other|IV placebo|IV placebo to match tanezumab every 8 weeks (through Week 16)
16270169|NCT00864084|Other|Pulmonary rehabilitation|Pulmonary rehabilitation involves the prescription of customized exercise programs and education on disease management.
16270170|NCT00864071|Drug|Griseofulvin 125 mg/5 mL Suspension, single dose|A: Experimental Subjects received Alpharma formulated products under fasting conditions
16270171|NCT00864071|Drug|Grifulvin V® 125 mg/5 mL Suspension, single dose|B: Active comparator Subjects received Ortho Neutrogena formulated products under fasting conditions
16270172|NCT00864058|Drug|Gabapentin 400 mg capsules|A: Experimental Subjects received Actavis formulated products under fasting conditions
16270173|NCT00864058|Drug|NEURONTIN® 400 mg capsules|B: Active comparator Subjects received Parke-Davis's marketed product
16270174|NCT00864045|Drug|Sertindole|Sertindole flexible doses per os, 12, 16 or 20mg/day according to response and tolerability, initially up-titrated from 4mg/day to target dose 16mg/day within the first 16 days
16270175|NCT00864045|Drug|Olanzapine|Olanzapine flexible doses per os, 10, 15 or 20mg/day according to response and tolerability, initially up-titrated from 10mg/day to target dose 15mg/day within the first 16 days
16270176|NCT00864032|Drug|Sorafenib|400mg twice daily
16270177|NCT00864019|Drug|Sertraline HCl 100 mg tablets, single dose|A: Experimental SSubjects received Purepac formulated products under non-fasting conditions
16270178|NCT00864019|Drug|Zoloft® 100 mg tablets, single dose|B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions
16270179|NCT00864006|Drug|Divalproex Sodium|
16270180|NCT00864006|Drug|Depakote DR Tablets|
16270181|NCT00863980|Drug|Micardis (Telmisartan)|40-80 mg/day oral administration
16270182|NCT00863980|Drug|Blopress (Candesartan)|8-12 mg/day oral administration
16270183|NCT00863954|Device|Resonator Device|comparison of different parameter settings of electromagnetic fields using the Resonator Device
16270184|NCT00863941|Drug|Abrika Bupropion 150 mg XL Tablet, single dose|A: Experimental Subjects received Abrika formulated products under fasting conditions
16270185|NCT00863941|Drug|Wellbutrin XL® 150 mg Tablet, single dose|B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
16270186|NCT00863928|Drug|belladonna 16.2 mg and opium 60 mg suppository|belladonna 16.2 mg and opium 60 mg suppository
16270187|NCT00863915|Drug|Ramipril10 mg Capsules, single dose|A: Experimental Subjects received Purepac formulated products sprinkled on one tablespoonful of applesauce
16270188|NCT00863915|Drug|Atlace® 10 mg capsules, single dose|B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products sprinkled on one tablespoonful of applesauce
16270189|NCT00863902|Drug|Cetirizine Hydrochloride 10 mg tablets, single dose|A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions
16270190|NCT00863902|Drug|Zyrtec® 10 mg tablets, single dose|B: Active comparator Subjects received Pfizer Inc. formulated products under fed conditions
16270191|NCT00863889|Drug|Depomedrol injection|1 cc of Depomedrol 80
16270193|NCT00863863|Drug|Griseofulvin 125 mg/5 mL Suspension, single dose|A: Experimental Subjects received Alpharma formulated products under non-fasting conditions
16270194|NCT00863863|Drug|Grifulvin V® 125 mg/5 mL Suspension, single dose|B: Active comparator Subjects received Ortho Neutrogena formulated products under non-fasting conditions
16270195|NCT00863850|Drug|bendamustine|Bendamustine 120 mg/m2 on Days 1 and 2 every 28 days (one cycle) for up to 6 cycles. Radiolabeled [14C] bendamustine will be given on day 1 of cycle 1 only.
16270196|NCT00863837|Drug|terlipressin (vasoconstrictor)|Ligation plus terlipressin 1mg q6h
16270197|NCT00863837|Drug|pantoloc (proton pump inhibitor)|Pantoloc infusion (1 vial q.d.); Using pantoloc to reduce rebleed after EVL
16270198|NCT00863798|Drug|Desvenlafaxine Succinate Sustained-Release 10mg|10 mg tablet, once daily dosing for 8 weeks
16270199|NCT00863798|Drug|Desvenlafaxine Succinate Sustained-Release 50 mg|50 mg tablet, once daily dosing for 8 weeks
16270200|NCT00863798|Drug|placebo|Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
16270201|NCT00863785|Drug|Corticoids plus N Acetyl Cysteine|40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
16270202|NCT00863772|Biological|tanezumab|5 mg dose Intravenously every 8 weeks for duration of study
16270203|NCT00863772|Biological|tanezumab|10 mg dose Intravenously every 8 weeks for duration of study
16270204|NCT00863772|Other|Placebo|Placebo, Intravenously, every 8 weeks for duration of study
16270205|NCT00863759|Procedure|implantation of intraocular lens (IOL)|"implantation of intraocular lens during cataract surgery.
~Arm 1: implantation of aspheric IOL Akreos AO in right eye and an spheric IOL Akreos Fit in left eye.
~Arm 2: implantation of aspheric IOL Akreos AO in left eye and an spheric IOL Akreos Fit in right eye."
16270206|NCT00863746|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg twice daily (BID)
16270207|NCT00863746|Drug|Placebo|Placebo - 2 tablets twice daily (BID)
16270208|NCT00863733|Drug|DMXAA|Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2
16270209|NCT00863707|Drug|Regadenoson|IV
16270210|NCT00863707|Drug|Placebo|IV
16270211|NCT00863681|Drug|Riociguat (BAY63-2521)|BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
16270212|NCT00863668|Drug|Efavirenz + Tenofovir DF/Emtricitabine|600mg QD for 52 weeks + 300mg/200mg QD for 52 weeks
16270213|NCT00863668|Drug|Raltegravir + Tenofovir DF/Emtricitabine|400mg BID for 52 weeks + 300mg/200mg QD for 52 weeks
16270214|NCT00863668|Procedure|Colonoscopy with biopsies|Day 0, Day 2, Day 7, Day 14, Week 52
16270215|NCT00863668|Procedure|Inguinal Lymph Node Excision|Day 0, Day 2, Day 7, Day 14, Week 52
16270216|NCT00863655|Drug|Everolimus|Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
16270217|NCT00863655|Drug|Exemestane|Exemestane 25 mg orally daily.
16270218|NCT00863655|Drug|Everolimus Placebo|Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
16270219|NCT00863642|Procedure|Laparoscopic cholecystectomy within 48 hours of admission|Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission
16270220|NCT00863642|Procedure|Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values|Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
16270221|NCT00863629|Drug|Insulin|In the CGC group, continuous insulin infusion was started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion was tapered slowed down and eventually stopped. In the IGC group, insulin infusion was started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. After the start of insulin infusion protocol a glycemic control was provided every hour in order to obtain three consecutive values that were within the goal range. Plasma glucose levels were checked every two hours in both CGC and IGT patients throughout the study period. The infusion lasted until stable glycemic goal (ICG group: 80-140 mg/dl; CGC group: 180-200 mg/dl) at least for 24 h. Subcutaneous insulin was initiated at the cessation of the infusion. Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening, in both group.
16270222|NCT00863616|Device|HFCWO - SmartVest|SmartVest with vest administered for 20min at 11-13Hz
16270223|NCT00863603|Other|oxygen|5 Liter/minute by nasal cannula for 6 wks
16270224|NCT00863590|Drug|odanacatib|[Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
16270225|NCT00863590|Drug|Comparator: odanacatib (Panel B)|Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
16270226|NCT00863590|Drug|Comparator: odanacatib (Panel C)|Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.
16270227|NCT00863590|Drug|Comparator: odanacatib (Panel D)|Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.
16270228|NCT00863577|Drug|Oral bemiparin|Bemiparin tablets and bemiparin tablets into hard gelatine capsules
16270229|NCT00863564|Dietary Supplement|Caseine|
16270230|NCT00863564|Dietary Supplement|Cod|
16270231|NCT00863564|Dietary Supplement|Gluten|
16270232|NCT00863564|Dietary Supplement|Whey Isolate|
16270235|NCT00863525|Drug|odanacatib|A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
16270236|NCT00863525|Drug|Comparator: Placebo|A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
16270237|NCT00863512|Drug|cisplatin|Given IV
16270238|NCT00863512|Drug|docetaxel|Given IV
16270239|NCT00863512|Drug|gemcitabine hydrochloride|Given IV
16270240|NCT00863512|Drug|pemetrexed disodium|Given IV
16270241|NCT00863512|Drug|vinorelbine tartrate|Given IV
16270242|NCT00863512|Procedure|standard follow-up care|Standard care
16270243|NCT00863499|Drug|Short Acting Methylphenidate|Dosage: 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
16270244|NCT00863499|Drug|Long Acting Methylphenidate|Dosage: 9 to 20 mg once daily in the morning (with or without food) with gradual increments of 9 to 20 mg weekly. Daily dosage above 60 mg is not recommended.
16270245|NCT00863473|Procedure|Surgical treatment with LCP|
16270246|NCT00863460|Radiation|cranial radiotherapy|40 Gy
16270247|NCT00863460|Drug|intensive chemotherapy and hematopoietic stem cell rescue|intensive chemotherapy and hematopoietic stem cell rescue
16270248|NCT00863460|Drug|MTX based chemotherapy|R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
16270249|NCT00863434|Drug|clofarabine|Given IV
16270250|NCT00863434|Drug|cytarabine|Given IV
16270251|NCT00863434|Biological|filgrastim|Given SC
16270252|NCT00863395|Procedure|skin biopsy|Lidocaine 1% c Epinephrine for local anesthesia
16270253|NCT00863382|Device|Standard Event Monitor|Standard Event Monitor
16270254|NCT00863382|Device|Sleuth Monitor|Implantable Sleuth Recorder
16270255|NCT00863369|Biological|rituximab|Given IV
16270256|NCT00863369|Drug|bortezomib|Given IV
16270257|NCT00863369|Drug|gemcitabine hydrochloride|Given IV
16270258|NCT00863369|Other|questionnaire administration|Ancillary studies
16270259|NCT00863356|Device|2009-I-Epistaxis-1|Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis, 48 hour removal, 1 week follow-up.
16270260|NCT00863343|Biological|Public Health Notification|For any H5 positive results, notification of the result to the site's local public health authorities.
16270261|NCT00863330|Biological|Tumor Infiltrating Lymphocytes (TIL)|Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
16270262|NCT00863317|Drug|montelukast sodium|4mg granules daily for 14 days
16270263|NCT00863317|Other|sucrose|table sugar as placebo daily for 14 days
16270264|NCT00863304|Biological|tanezumab 10 mg|tanezumab 10 mg one dose at weeks 0 and 8
16270265|NCT00863304|Biological|tanezumab 5 mg|tanezumab 5 mg one dose at weeks 0 and 8
16270266|NCT00863304|Drug|naproxen|naproxen 1000 mg daily for 16 weeks
16270267|NCT00863304|Other|placebo|placebo to match tanezumab and naproxen dosing
16270268|NCT00863291|Drug|buprenorphine|buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
16270269|NCT00863291|Drug|placebo|Placebo in a manner similar to the active comparator
16270270|NCT00863278|Procedure|pulsed dye laser treatment|On one side of the face according to Arm placement.
16270271|NCT00863278|Drug|Kligman's Trio|The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.
16270272|NCT00863265|Drug|Ezetimibe|Subjects will undergo three diet periods of 21 days each separated by 7 day washouts. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. During each period subjects will receive either phytosterol esters or placebo and ezetimibe or placebo.
16270273|NCT00863265|Other|Phytosterols + ezetimibe|Subjects will undergo three diet periods of 21 days each separated by 7 day washouts. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. During each period subjects will receive either phytosterol esters or placebo and ezetimibe or placebo.
16270274|NCT00863265|Other|Placebo|
16270275|NCT00863252|Drug|mycophenolate mofetil|Orally at 0.75 g bd to 1 g bd for 6 months
16270276|NCT00863252|Drug|angiotensin blockade|Continuation of angiotensin blockade
16270277|NCT00863239|Drug|ribavirin|Co-administered in all arms: oral ribavirin, 200 mg capsules. Subjects with body weight < 65 kg: 800 mg/day; Subjects with body weight 65-85 kg: 1000 mg/day; Subjects with body weight > 85 kg: 1200 mg/day.
16270278|NCT00863239|Drug|Locteron™ (controlled-release interferon alpha 2b)|investigational controlled-release recombinant interferon alpha 2b formulated in 1500/77/23 PolyActive microspheres as a lyophilized powder, reconstituted with carboxymethyl cellulose immediately before subcutaneous injection every other week as part of the treatment of chronic hepatitis C
16270279|NCT00863239|Drug|PEG-Intron™|commercially available pegylated interferon alpha 2b injected subcutaneously weekly in a dose of 1.5 ug/kg as part of the treatment of chronic hepatitis C
16270280|NCT00863226|Device|Resonator Device|Application of Magnetic Fields Using the Resonator Device
16270281|NCT00863213|Procedure|Atrial fibrillation ablation|"Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used.
~It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested."
16270282|NCT00863213|Drug|Antiarrhythmic drug|Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.
16270283|NCT00863200|Behavioral|Telephone Intervention|Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.
16270284|NCT00863200|Behavioral|Questionnaires & Interviews|3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.
16270285|NCT00863187|Biological|rituximab|b cell depletion
16270286|NCT00863174|Drug|SPARC147709|SPARC147709 injection
16270289|NCT00863148|Drug|Clofarabine in combination with IV busulfan and ATG|A conservative approach has been used for the determination of the dose due to the high risk studied population, e.g., decrease to 30 mg m²/day for a 4-day course of clofarabine. Clofarabine will be started at Day -8 to allow improvement of liver function tests, if any, by time of allo-HSCT. Clofarabine (C) 30 mg/m²/day for 4 days (day -8 to day-5). Busilvex (B): 3.2 mg/kg/day for 2 days (day -4 and day-3)Thymoglobuline (T): 2.5 mg/Kg/day for 2 days (day -2 and day-1). Graft (G) at day 0 GVHD prophylaxis: Cyclosporine 3 mg/kg/day starting day-1. Genzyme provided supplies of clofarabine for all patients included in the study.
16270290|NCT00863135|Device|CPAP|continuous positive airways pressure
16270291|NCT00863135|Device|Control|Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time
16270292|NCT00863122|Drug|lapatinib|1500 mg lapatinib by mouth per day for 10 days
16270293|NCT00863109|Biological|Peginterferon alfa-2b (PEG)|Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
16270294|NCT00863109|Drug|Ribavirin (RBV)|Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
16270295|NCT00863096|Biological|Gardasil|HPV vaccine
16270296|NCT00863083|Behavioral|Multifamily weight management intervention|8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.
16270297|NCT00863057|Drug|Duloxetine|During each treatment period, participants will take duloxetine in the following doses. On Days 1 to 5, participants will take one 30-mg capsule orally, once daily. On Days 6 to 28, participants will take two 30-mg capsules orally, once daily. During days 29 to 31 dosage will be reduced to one capsule daily and then discontinued on Day 32.
16270298|NCT00863057|Drug|Duloxetine placebo|During each treatment period, participants will take duloxetine placebo in the following doses. On Days 1 to 5, participants will take one 30-mg capsule orally, once daily. On Days 6 to 28, participants will take two 30-mg capsules orally, once daily. During days 29 to 31 dosage will be reduced to one capsule daily and then discontinued on Day 32.
16270299|NCT00863057|Drug|Methadone|During each treatment period, participants will take methadone in the following doses. On Days 1 to 5, participants will take one 5-mg capsule orally, twice daily. On Days 6 to 10, participants will take one 5-mg capsule orally, three times daily. On Days 11 to 28, participants will take two 5-mg capsules orally, three times daily. On Days 29 to 31, dosage will be one 5-mg capsule orally, three times daily. On Days 32 to 34, dosage will be decreased to one 5-mg capsule, twice daily and ultimately discontinued on Day 35.
16270300|NCT00863057|Drug|Methadone placebo|During each treatment period, participants will take methadone placebo in the following doses. On Days 1 to 5, participants will take one 5-mg capsule orally, twice daily. On Days 6 to 10, participants will take one 5-mg capsule orally, three times daily. On Days 11 to 28, participants will take two 5-mg capsules orally, three times daily. On Days 29 to 31, dosage will be one 5-mg capsule orally, three times daily. On Days 32 to 34, dosage will be decreased to one 5-mg capsule, twice daily and ultimately discontinued on Day 35.
16270301|NCT00863044|Procedure|Apnea|Ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.
16270302|NCT00863044|Procedure|High frequency ventilation|The patients will be ventilated using a tidal volume of 1.5 ml per Kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.
16270303|NCT00863031|Behavioral|problem-solving therapy|Three sessions of problem-solving therapy at week 1, 3 and 5.
16270304|NCT00863031|Behavioral|Video-viewing|Three sessions of viewing health educational videos.
16270305|NCT00863005|Drug|K201|Cream
16270306|NCT00863005|Drug|K201|
16270307|NCT00862992|Drug|Cariprazine 3 mg|
16270308|NCT00862992|Drug|Cariprazine 6 mg|
16270309|NCT00862992|Drug|Cariprazine 12.5 mg|
16270310|NCT00862979|Drug|Everolimus (EVR)|Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)
16270311|NCT00862979|Drug|cyclosporine A (CyA)|10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only
16270312|NCT00862979|Drug|tacrolimus (TAC)|0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only
16270313|NCT00862979|Drug|Enteric coated mycophenolate sodium (EC-MPS)|180 mg or 360 mg tablet dosed 1440-2280 mg per day
16270314|NCT00862979|Drug|mycophenolate mofetil (MMF)|250 mg or 500 mg tablets with a dose of 1500-3000 mg per day
16270315|NCT00862979|Drug|Corticosteroids|according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent
16270316|NCT00862966|Other|citrate|comparison of different catheter lock solutions
16270317|NCT00862966|Other|heparin|comparison of different lock solutions
16270318|NCT00862953|Dietary Supplement|Normal protein energy-restricted|Normal protein diet energy restricted
16270319|NCT00862953|Dietary Supplement|High protein energy-restricted|High protein diet, with either low or normal carbohydrate content
16270320|NCT00862940|Drug|Memantine|10 mg tablets twice daily
16270321|NCT00862940|Drug|Placebo|Tablets twice daily
16270322|NCT00862927|Other|Breath Sample|Breathe into machine measuring carbon monoxide.
16270323|NCT00862927|Other|Saliva Sample|Chew cotton ball for 30 seconds for cotinine measurement.
16270324|NCT00862927|Behavioral|Questionnaire|6 surveys, taking approximately 30 minutes total.
16270325|NCT00862927|Behavioral|View Virtual Reality Scenes|Use virtual reality helmet and hand-held controller to answer questions about 4 viewing scenes while wearing physiological measurement skin sensors, approximately 6 minutes.
16270326|NCT00862901|Device|CLIPT patch|A Diomed laser will deliver 630nm (red spectrum) light through a Fiber optic Patch. The Fiber Optic Patch will be compatible with the laser, delivering light to a designated region on the patient's skin. Patients will receive a single intravenous injection of Photofrin (0.8mg/kg body weight) 36 - 48 hours prior to the CLIPT procedure. PDT will be delivered over 24 hours for the dose of each arm. Patients will be enrolled in sequential cohorts of six, at increasing laser intensity until the maximum tolerated dose is reached.
16270327|NCT00862888|Drug|PF-00446687|Single 200mg dose as an oral solution
16270337|NCT00862875|Drug|Detemir or Glargine|Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L.
16270338|NCT00862849|Drug|Insulin Lispro|
16270339|NCT00862849|Drug|Regular Human Insulin|
16270340|NCT00862849|Drug|rHuPH20|
16270341|NCT00862836|Drug|Vandetanib|100mg doses orally, once daily
16270342|NCT00862823|Drug|tenofovir, emtricitabine and efavirenz fixed dose tablet|Atripla contains 300mg of tenofovir, 200mg of emtricitabine and 600mg of efavirenz
16270343|NCT00862823|Drug|tenofovir, emtricitabine and efavirenz tablet added to solution|Atripla contains 300mg of tenofovir, 200mg of emtricitabine and 600mg of efavirenz
16270344|NCT00862810|Biological|Received HPV vaccine first|
16270345|NCT00862810|Biological|Received concomitant vaccines first|
16270346|NCT00862797|Other|pressure measurement during swallowing|measurement of endotracheal tube cuff pressure during swallowing while recovering from anaesthesia
16270347|NCT00862784|Biological|IMC-1121B (ramucirumab)|8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks
16270348|NCT00862784|Drug|Oxaliplatin|85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1
16270349|NCT00862784|Drug|Folinic acid|400 mg/m² intravenous infusion over 2 hours on Day 1
16270350|NCT00862784|Drug|5-FU|400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion
16270351|NCT00862784|Drug|5-FU|2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2
16270352|NCT00862758|Drug|Tocilizumab|8 mg/kg would be administered IV every 2 weeks for six weeks.
16270353|NCT00862745|Drug|Fesoterodine|Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment.
16270354|NCT00862745|Drug|Matching Placebo|Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment.
16270355|NCT00862732|Behavioral|Cognitive behavioural therapy|Will receive a series of sessions of cognitive behaviour therapy. Delivery of CBT will be by three therapists; PI and two other Medical Officers. Each session will last for 30- 45 minutes and they will be delivered at the participant's residence (or at an alternative place of participant's choice) at two weeks intervals. They will be followed-up for three months from the cessation of CBT sessions.
16270356|NCT00862732|Other|Treatment as usual|Will be referred to the MO(MH). They also will be followed-up for an equal length of time period as of the participants in the intervention group.
16270357|NCT00862719|Drug|Sitagliptin|600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.
16270358|NCT00862706|Drug|Telbivudine/LDT600A|Oral once daily
16270359|NCT00862693|Drug|Calcitriol|0.5ug/Biw
16270360|NCT00862680|Procedure|4-Dimensional Computed Tomography|Undergo 4D PET/CT
16270361|NCT00862680|Procedure|4D PET Scan|Undergo 4D PET/CT scan
16270362|NCT00862667|Drug|Treatment A|PF-00241939 300ug using Inhaler A
16270363|NCT00862667|Drug|Treatment B|PF-00241939 300ug using Inhaler B
16270364|NCT00862667|Drug|Treatment C|PF-00241939 300ug using Inhaler C
16270365|NCT00862654|Drug|clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)|Association: clobetasol propionate shampoo & ketoconazole shampoo
16270366|NCT00862654|Drug|clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)|Association: clobetasol propionate shampoo & ketoconazole shampoo
16270367|NCT00862654|Drug|clobetasol propionate shampoo (2/week)|Monotherapy with clobetasol propionate shampoo
16270368|NCT00862654|Drug|ketoconazole shampoo (2/week)|Monotherpay ketoconazole shampoo (2/week)
16270369|NCT00862641|Drug|Regadenoson|IV
16270370|NCT00862641|Drug|Placebo|IV
16270371|NCT00862628|Drug|Rebamipide|100mg tid, 4 or 8 weeks
16270372|NCT00862615|Other|Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.|"Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
~Isotopes are :
~(13C)bicarbonate (0.09 mg/kg fat-free mass) and L(1-13C)leucine (1.3 mg/kg fat-free mass) (intravenous way) L-(5,5,5 2H3) leucine(0.09 µmoles/(kg de fat-free mass.min) (oral way)"
16270373|NCT00862602|Behavioral|Stepping Up to Health|Internet-mediated pedometer-based intervention with gradually increasing goals and feedback on step counts. Also includes educational content targeted at women who have had gestational diabetes about exercise, diet & nutrition and prevention.
16270374|NCT00862589|Other|GLP-1 infusion|physiological effect of GLP-1
16270375|NCT00862563|Drug|Topiramate|Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
16270376|NCT00862563|Drug|Zonisamide|Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
16270377|NCT00862563|Drug|Levetiracetam|Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
16270378|NCT00862563|Drug|Sugar Pill|Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
16270379|NCT00862550|Other|Acupuncture|20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
16270380|NCT00862537|Device|Resonator Device|active pico-tesla magnetic fields treatment for Parkinson's disease individuals
16270381|NCT00862524|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|multiple dose, escalating
16270382|NCT00862524|Drug|Gemcitabine, nucleoside analogue; intravenous|multiple dose, single schedule
16270383|NCT00862511|Device|Coated Total Knee Arthroplasty|Implantation of a coated Total Knee Arthroplasty
16270384|NCT00862511|Device|Standard Total Knee Arthroplasty|Implantation of a Standard Total Knee Arthroplasty
16270385|NCT00862498|Other|Written Disclosure|Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes. The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
16270386|NCT00862472|Drug|DuoTrav APS|DuoTrav APS QD AM
16270387|NCT00862472|Drug|DuoTrav|DuoTrav QD AM
16270388|NCT00862459|Drug|Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
16270389|NCT00862459|Drug|Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
16270390|NCT00862459|Drug|Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
16270391|NCT00862459|Drug|OptiMARK~0.1 mmol/kg BW|Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
16270392|NCT00862446|Drug|Omegaven|1 gram/kg/day daily until on feeds
16270396|NCT00862420|Drug|clopidogrel (SR25990)|oral administration (tablets)
16270397|NCT00862420|Drug|ticlopidine|oral administration (tablets)
16270398|NCT00862394|Drug|BDP/Formoterol Next DPI|BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
16270399|NCT00862394|Drug|Foster|BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
16270400|NCT00862394|Drug|BDP/Formoterol Next DPI|BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
16270401|NCT00862394|Drug|Foster|BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
16270402|NCT00862381|Drug|Hydrocortisone|hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment
16270403|NCT00862381|Drug|Placebo|NaCl 0.9%
16270404|NCT00862368|Behavioral|PAM|Visit 1 included asthma education (or child wellness for healthy children), expired air carbon monoxide feedback, Motivational Interviewing, and techniques to accelerate the participants readiness to quit. Visit 2 included a follow up on the child's asthma (PAM and PAM-Enhanced only), assessing the smoker's motivation to quit, feedback on CO readings and air sampler results (smoke exposure to the child), risks of smoking, and benefits of quitting. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
16270405|NCT00862368|Behavioral|PAM-Enhanced/Asthma Counseling Phone Calls|PAM-Enhanced/Asthma counseling calls were made over the 4 months following in-home counseling and focused on: 1) checking in on the child's asthma, 2) motivating quit attempts, and 3) preventing relapse among quitters. The final phone call (#6) included feedback on the 2nd set of air samplers placed in the home and with the child after phone call 5. Only the PAM-Enhanced/Asthma condition received this 2nd round of ETS feedback. A printed feedback report was provided to participants. If still smoking, counseling focused on ETS reduction and motivation to change. If quit, counseling focused on reinforcement of successful behavior change and motivation to stay quit. Motivational Interviewing techniques were used. Free nicotine patch tx was given if they were ready to quit within 30 days.
16270406|NCT00862368|Behavioral|Follow-Up Phone Calls - Child Wellness Topic|Over the 4 months following in-home counseling visits, subjects in the PAM-Asthma and PAM-Healthy conditions received 6 phone calls that included an asthma check-in (PAM-Asthma only) and discussion of a child wellness topic. Counselors employed Motivational Interviewing techniques. Free nicotine patch tx was given if they were ready to quit within 30 days.
16270407|NCT00862355|Drug|SPARC147609|IV infusion
16270408|NCT00862355|Drug|Reference147609|IV infusion
16270409|NCT00862342|Drug|Bevacizumab (Avastin)|Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)
16270410|NCT00862329|Dietary Supplement|Casein-enriched diet|Subjects consume for 9 days a supplement of 30g/d of casein
16270411|NCT00862329|Dietary Supplement|Milk soluble protein-enriched diet|Subjects consume for 9 days a supplement of 30g/d of milk soluble protein
16270412|NCT00862329|Dietary Supplement|Casein and milk soluble proteins-enriched diet|Subjects consume for 9 days a supplement of 30g/d of a mix of casein and milk soluble protein
16270413|NCT00862329|Dietary Supplement|Soy proteins-enriched diet|Subjects consume for 9 days a supplement of 30g/d of soy protein
16270414|NCT00862316|Device|Oxford Unicompartmental Knee|Knee Arthroplasty
16270415|NCT00862303|Biological|DC-CIK|Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
16270416|NCT00862303|Drug|IL-2/IFN-α|Patients receive treatment of IL-2 or IFN-α.
16270417|NCT00862277|Biological|Menactra®|0.5 mL, Intramuscular (from a previous study)
16270418|NCT00862277|Biological|Menomune®|0.5 mL, Intramuscular (from a previous study)
16270419|NCT00862264|Drug|Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI|Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
16270420|NCT00862251|Drug|ezetimibe (+) simvastatin|ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
16270421|NCT00862251|Drug|simvastatin 40 mg or atorvastatin 20 mg|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
16270422|NCT00862251|Drug|Rosuvastatin|rosuvastatin 10 mg tablets, taken once daily for six weeks.
16270423|NCT00862251|Drug|atorvastatin 10 mg or simvastatin 20 mg|All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
16270424|NCT00862238|Behavioral|Art Messaging|4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, & C
16270465|NCT00861926|Drug|Ventolin|Ventolin : salbutamol sulfate 100µg
16270425|NCT00862238|Other|Health Promotion|4 session education which offers basic information about the prevention of hepatitis A, B, & C
16270426|NCT00862225|Drug|Placebo|Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
16270427|NCT00862225|Drug|Desloratadin|Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
16270428|NCT00862225|Drug|IG-RD-001 / Ze 339|Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
16270429|NCT00862212|Behavioral|Brief Alcohol Intervention|At the Week 6 visit, all subjects who are randomized to the Experimental Group will receive the experimental brief alcohol intervention. The intervention will be in addition to a standard 20-minute physician visit, for a maximum of 30 minutes. The physician will use the Updated NIAAA Clinician's Guide to ask about drinking and will draw the connection between social anxiety and drinking and how they relate to each other. Subjects will be asked to consider making changes in their drinking and if they agree, a goal will be set and progress toward that goal will be monitored at subsequent visits.
16270430|NCT00862186|Behavioral|'Fatigue Facts & Fixes'|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
16270431|NCT00862160|Device|ROCsafeTM|using minimized perfusion circuit while CABG
16270432|NCT00862147|Behavioral|ICDP|Parent training group
16270433|NCT00862147|Behavioral|Treatment as usual|Parent and/or child focused interventions
16270434|NCT00862134|Drug|PR104|770 mg/m^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
16270435|NCT00862134|Drug|docetaxel|75 mg/m^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
16270436|NCT00862134|Drug|docetaxel|60 mg/m^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
16270437|NCT00862134|Drug|Granulocyte colony-stimulating factor|Subjects randomized to PR104/docetaxel will receive prophylactic G-CSF per package insert administration recommendations. Number of Cycles: until progression or unacceptable toxicity develops.
16270438|NCT00862121|Drug|Pentasa|6 g/day orally, 2 g in the morning and 4 g in the evening
16270439|NCT00862121|Drug|Placebo|6 g/day orally, 2 g in the morning and 4 g in the evening
16270440|NCT00862108|Drug|Methylphenidate|mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks
16270441|NCT00862095|Drug|Placebo|Every month for 3 months
16270442|NCT00862095|Drug|Propranolol|target does 80 mg per day for 3 months
16270443|NCT00862095|Drug|Amitriptyline|Target does of 50 mg per day for 3 months
16270444|NCT00862095|Drug|Topiramate|Target dose 100 mg a day for 3 months
16270445|NCT00862082|Drug|PR104 550 mg/m^2 + sorafenib|550 mg/m^2 PR104 IV on day 1 of each 28 day cycle + 400 mg sorafenib PO twice daily. Number of Cycles: until progression or unacceptable toxicity develops.
16270446|NCT00862082|Drug|PR104 770 mg/m^2 + sorafenib|770 mg/m^2 PR104 IV on day 1 of each 28 day cycle + 400 mg sorafenib PO twice daily. Number of Cycles: until progression or unacceptable toxicity develops.
16270447|NCT00862056|Procedure|Cardiac CT|All participants will undergo a coronary artery CT angiogram with contrast.
16270448|NCT00862043|Drug|Sildenafil Citrate|40 mg t.i.d.
16270449|NCT00862043|Drug|Placebo|Placebo t.i.d.
16270450|NCT00862030|Procedure|CT- simulation scan|Patients who are receiving standard palliative radiotherapy planned under x-rays will also undergo 1 CT-simulation scan which they would otherwise not require. The planning x-rays and CT scan will then be compared dosimetrically
16270451|NCT00862017|Dietary Supplement|MSg supplementation|
16270452|NCT00862017|Dietary Supplement|NaCl supplementation|
16270453|NCT00862004|Procedure|VATS|video-assisted thoracoscopic surgery (VATS) major pulmonary resection with systematic node dissection (SND) for clinical stage IIIA non-small cell lung cancer
16270454|NCT00861991|Behavioral|Perspective taking instruction|Students were asked to take the perspective of their standardized patients during clinical skills examinations
16270455|NCT00861978|Drug|St. John's Wort extract|Coated tablets (batch no. 02080277) containing 300 mg of St. John's Wort extract LI 160 (drug-extract ratio 3-6:1; extraction solvent: 80% Methanol in water; batch no. 02019073) administered orally twice daily (morning and evening) with some liquid for 8 weeks
16270456|NCT00861978|Drug|Placebo|Coated placebo tablets (batch no. 01010177) that were identical in shape, size, taste and color were administered orally twice daily (morning and evening) with some liquid for 8 weeks.
16270457|NCT00861965|Biological|AlloStim-8|intravenous infusion of mis-matched AlloStim-8
16270458|NCT00861965|Biological|AlloStim-8|intravenous infusion of AlloStim-8 on day 7
16270459|NCT00861965|Biological|AlloStim-8|intravenous infusion of AlloStim-8 on day 14
16270460|NCT00861965|Biological|AlloStim-8|intravenous infusion of AlloStim-8 on day 21
16270461|NCT00861952|Other|Neuragen|2-3 drops applied topically 2-3 times per day as needed over a 3 month period
16270462|NCT00861952|Other|Mineral oil|Ad lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application
16270463|NCT00861939|Drug|Bupropion HCI 300 mg Extended-Release Tablets EON|
16270464|NCT00861939|Drug|WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline|
16270466|NCT00861926|Drug|beclometasone /formoterol|BDP 100µg/FF 6µg, 1 inhalation bid
16270467|NCT00861913|Other|Laboratory Biomarker Analysis|Correlative studies
16270468|NCT00861913|Drug|Pazopanib Hydrochloride|Given orally
16270469|NCT00861913|Other|Pharmacological Study|Correlative studies
16270470|NCT00861887|Drug|Standard Vancomycin|Vancomycin treatment 125 mg po every 6 hours x 2 weeks
16270471|NCT00861887|Drug|Extended Vancomycin|Vancomycin 125 mg every 6 hours x 2 weeks
16270472|NCT00861874|Drug|Decitabine|20 mg/m2 IV, Days 1-5
16270473|NCT00861874|Drug|Rapamycin|Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26
16270474|NCT00861861|Drug|Pitavastatin|comparison of two drugs in increasing HDL-C and adiponectin
16270475|NCT00861861|Drug|Atorvastatin|comparison of two drugs in increasing HDL-C and adiponectin
16270476|NCT00861835|Other|ROSE|rapid on-site evaluation by cytopathology
16270477|NCT00861822|Other|Advanced red blood cell transfusion|"Sixty anemic (Hg 100-120 g/L) adult patients undergoing cardiac surgery with CPB will be randomized to the 'advance RBC transfusion' (ART) group or the standard-of-care RBC transfusion' (SRT) group (1:1 ratio).
~In the ART group, subjects will receive 1-2 units of stored RBCs 1-2 days before surgery to reach a target Hb of 130-140 g/L. Each unit of blood will be transfused over 2 hours under medical supervision, with appropriate monitoring and management of fluid status to ensure patients are not over-hydrate"
16270478|NCT00861809|Drug|GSK962040 25 mg|25 mg
16270479|NCT00861809|Drug|Placebo|placebo comparator
16270480|NCT00861809|Drug|GSK962040 50 mg|50 mg
16270481|NCT00861809|Drug|GSK962040 1250 mg|125 mg
16270482|NCT00861796|Drug|CYR-101|Experimental arm
16270483|NCT00861796|Drug|Placebo|Placebo comparator
16270484|NCT00861783|Drug|irinotecan and ON 01910.Na|"ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher levels based on safety of the combination regimen in the previous cohort.
~Irinotecan 180 mg/m2 will initially be administered by IV infusion over 90 minutes q2 weeks of a 6-week cycle (3 doses per cycle). Dose modifications due to toxicity will be instituted according to approved labelling."
16270485|NCT00861783|Drug|oxaliplatin and ON 01910.Na|"ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher levels based on safety of the combination regimen in the previous cohort.
~Oxaliplatin 85 mg/m2 will initially be administered by IV infusion over 120 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Dose modifications due to toxicity will be instituted according to approved labeling."
16270486|NCT00861770|Other|Ultrafiltration|Ultrafiltration based on standard of care.
16270487|NCT00861770|Other|Ultrafiltration using BVM|Ultrafiltration will be guided by blood volume measurement results.
16270488|NCT00861757|Drug|Tadalafil|by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
16270489|NCT00861757|Drug|Placebo|PO, QD (30 min after meal) for 12 weeks
16270490|NCT00861757|Drug|Tamsulosin|PO, QD (30 min after meal) for 12 weeks
16270491|NCT00861744|Biological|GSK Biological's investigational vaccine 209762|Subcutaneous injection, one dose
16270492|NCT00861744|Biological|M-M-R® II (Merck and Co)|Subcutaneous injection, one dose
16270493|NCT00861744|Biological|Varivax®|Subcutaneous injection, one dose
16270494|NCT00861744|Biological|Havrix®|Intramuscular injection, one dose
16270495|NCT00861744|Biological|Prevnar®|Intramuscular injection, one dose
16270496|NCT00861731|Drug|simvastatin|simvasatin therapy alone at the dose of 40 mg/day
16270497|NCT00861731|Drug|EZE/simvastatin|EZE/simvastatin combined therapy at the dose of 10/20 mg/day
16270498|NCT00861731|Drug|EZE/simvastatin|EZE/simvastatin combined therapy at the dose of 10/40 mg/day
16270499|NCT00861718|Drug|AZD7268|Capsule, Oral, QD
16270500|NCT00861718|Drug|AZD7268|Capsule, Oral, BID
16270501|NCT00861718|Drug|Placebo|Capsule, Oral BID
16270502|NCT00861705|Biological|Bevacizumab|Given IV
16270503|NCT00861705|Drug|Carboplatin|Given IV
16270504|NCT00861705|Drug|Cyclophosphamide|Given IV
16270505|NCT00861705|Drug|Doxorubicin Hydrochloride|Given IV
16270506|NCT00861705|Other|Laboratory Biomarker Analysis|Correlative studies
16270507|NCT00861705|Drug|Paclitaxel|Given IV
16270508|NCT00861692|Drug|argatroban|
16270509|NCT00861679|Procedure|Transplantation with Stem Cells from Umbilical Cord|"According to results from published experiences in children following suggestions are given:
~Number of Cells:
~Number of nucleated cells infused exceed 2,5x10*7/kg recipient BW or
~Number of nucleated cells collected exceed 3x10*7/kg BW
~Number of CD34+ cells infused exceed 2x10*5/kg Recipient BW
~GVHD-prophylaxis:
~• MSD: CSA 3 mg/kg as described in the protocol + Prednisolone 1 mg/kg (day O to day 15, then tapering until day 28)
~• UD: as above + additional immunosuppression according to local protocols; ATG might increase risk of infectious complication and might be replaced by other drugs according to local protocols.
~HLA-matching for unrelated CB: a matched UB is defined by 6/6 HLA matches (A, B antigenic medium resolution and DRB1 allelic) and allocate to the transplantation group MD. Less than 6/6 HLA matches allocate the patient to the MMD group.
~If many choices available ABO- major incompatibility should be avoided."
16270510|NCT00861666|Behavioral|Forgiveness-Based Writing|"Participants will be asked to complete self-report measures during the initial session, will be given writing instructions and will complete the first writing task on-site. The first writing task will focus on describing an offense in which someone hurt or angered the participant, and about which the participant is still hurt and angry.
~Eleven additional writing tasks will be completed at home, three per week for a month. Writing assignments will include topics such as describing thoughts and feelings about the offense, identifying possible motives or mitigating circumstances, identifying benefits of the offense itself, identifying times when one has offended others and how one felt afterwards, identifying benefits of letting go of the offense, and writing a letter to the offender.
~Participants will return each written assignment to the study staff. All participants will be tracked closely by the study coordinator and receive a reminder phone call on the day of each writing task."
16270511|NCT00861640|Drug|Intravenous Omeprazole|Intravenous Omeprazole 1amp qd (every day)
16270512|NCT00861640|Drug|Oral Rabeprazole|Oral Rabeprazole 1 bid
16270513|NCT00861627|Biological|REOLYSIN®|3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
16270514|NCT00861627|Drug|Carboplatin|5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
16270515|NCT00861627|Drug|Paclitaxel|175 mg/m2, 3 hour intravenous infusion, given on Day 1 of 21 day cycle
16270516|NCT00861614|Drug|Ipilimumab|5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
16270517|NCT00861614|Drug|Placebo|Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
16270518|NCT00861601|Drug|eltrombopag 12.5 milligrams (mg) tablet|eltrombopag 12.5 mg tablet once a day
16270519|NCT00861601|Drug|eltrombopag 25 mg tablet|eltrombopag 25 mg tablet once a day
16270520|NCT00861588|Drug|isoflavones (Soylife 25)|40mg of soy isoflavones capsule (once daily)
16270521|NCT00861588|Drug|placebo|starch placebo
16270522|NCT00861562|Drug|Imescard water smartweed composed pills|01 pill at every 8 hours for 5 days.
16270523|NCT00861562|Drug|Placebo|01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.
16270524|NCT00861549|Drug|Phencynonate hydrochloride|2mg/tablet
16270525|NCT00861536|Drug|ATG Fresenius|Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
16270526|NCT00861536|Drug|Thymoglobuline Genzyme|Day 0-3: 1.5 mg/kg bw/d
16270527|NCT00861523|Drug|thiamine & promethazine|thiamine 100 mg IV promethazine 25 mg IV
16270528|NCT00861510|Drug|ON01910 Na|
16270529|NCT00861497|Drug|Bifeprunox|Flexible dosage: 20, 30, or 40 mg/day
16270530|NCT00861484|Drug|GSK958108|Coated Tablets 1 mg
16270531|NCT00861484|Drug|Placebo|Coated tablets
16270532|NCT00861471|Drug|Docetaxel|"One treatment cycle is defined as 21 days.
~Docetaxel: 70 mg/m^2 (60 mg/m^2 was tested in Phase I as well), Intravenous, every 21 days."
16270533|NCT00861471|Drug|Imatinib Mesylate|"One treatment cycle is defined as 21 days.
~Imatinib Mesylate: 24-36 hours after Docetaxel, 600 mg (400 mg was tested in Phase I as well), orally, daily x 14 days."
16270534|NCT00861458|Drug|Pharmacokinetics|Single dose of 750 mg PF-00868554 as a solution and tablets.
16270535|NCT00861445|Drug|SPM927/Lacosamide|SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
16270536|NCT00861445|Other|Placebo|Placebo tablets two times a day for 10 weeks
16270537|NCT00861432|Other|additive homeopathic treatment|These patients receive additive homeopathic treatment
16270538|NCT00861419|Drug|Sorafenib|Sorafenib 400 mg PO (BID)
16270539|NCT00861419|Drug|AMG 706|AMG 706 125 mg PO (QD)
16270540|NCT00861419|Drug|AMG 706|AMG 706 75 mg PO (QD)
16270541|NCT00861419|Drug|AMG 386|AMG 386 10 mg/kg IV (QW)
16270542|NCT00861419|Drug|Sunitinib|Sunitinib 50 mg PO (QD)
16270543|NCT00861419|Drug|Bevacizumab|Bevacizumab 15mg/kg IV Q3W
16270544|NCT00861419|Drug|AMG 386|AMG 386 3 mg/kg IV (QW)
16270545|NCT00861406|Drug|Pegylated Interferon-Alfa 2b (PEG Intron)|"Group 1:
~6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks.
~Group 2:
~6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks.
~Group 3:
~6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks."
16270546|NCT00861406|Drug|GP-100 Peptide Vaccine|Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
16270547|NCT00861393|Behavioral|CBT|12 Session CBT group
16270548|NCT00861393|Behavioral|Waitlist CBT|Participants in the waitlist will receive CBT when first group has completed CBT and been tested.
16270549|NCT00861380|Biological|Pneumococcal conjugate vaccine GSK1024850A|2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
16270550|NCT00861380|Biological|GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)|"3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.
~Control 3+1 and Control 2+1 groups, only for children < 12 months of age at the time of first study vaccination."
16270551|NCT00861380|Biological|GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)|2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children >= 12 months of age at the time of first study vaccination.
16270552|NCT00861367|Drug|transurethral surgery with or without aspirin|aspirin 100mg once a day, transurethral surgery with or without aspirin
16270553|NCT00861354|Device|Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)|Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.
16270554|NCT00861341|Drug|Aspirin|81 mg
16270555|NCT00861341|Drug|Pioglitazone|30mg Pioglitazone x1
16270556|NCT00861328|Drug|ON 01910.Na and irinotecan|"ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher dose levels after safety evaluation.
~The suggested starting dose of Irinotecan is 180 mg/m2 administered by intravenous (IV) infusion over 90 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent."
16270557|NCT00861328|Drug|ON 01910.Na and oxaliplatin|"ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher dose levels after safety review of the combination regimen in the previous cohort.
~The suggested starting dose of Oxaliplatin is 85 mg/m2 administered by IV infusion over 120 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent."
16270711|NCT00860171|Radiation|Iodine I 131 Monoclonal Antibody BC8|Given IV
16270558|NCT00861315|Drug|Nebulized amikacin|Amikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm)
16270559|NCT00861315|Drug|Intravenous amikacin|20 mg/Kg amikacin are administred intravenousely once a day during three days.
16270560|NCT00861315|Drug|Placebo nebulization|0.9% saline solution is nebulized once a day during three days
16270561|NCT00861315|Drug|Placebo infusion|0.9% saline is administered intravenousely once a day during three days
16270562|NCT00861302|Behavioral|Mind-body emotional awareness program|This intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem.
16270563|NCT00861276|Drug|Nasal Spray Nicotine Substitute (Experimental)|During the first month, subjects in the intervention group received instruction from the physician to use NNS regularly (at least 2 puffs/hour, for an average of 1 mg nicotine/hour when awake).
16270564|NCT00861276|Drug|Nasal Spray Nicotine Substitute (ad libitum)|In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.
16270565|NCT00861263|Device|overtube use during enteroscopy|use of overtube for the regular scheduled enteroscopy
16270566|NCT00861250|Drug|bortezomib + dexamethasone|Bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT
16270567|NCT00861237|Drug|Nux vomica (active comparator)|Patients receive Nux vomica in a homeopathic potentiation
16270568|NCT00861237|Drug|Placebo (placebo comparator)|Patients receive Placebo looking similar to active drug
16270569|NCT00861224|Other|No Intervention for Observational Study|No intervention was used on this protocol, as this was an observational study.
16270570|NCT00861211|Drug|senicapoc|Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days
16270571|NCT00861211|Drug|Placebo|Placebo comparator
16270572|NCT00861198|Other|ERCP as per medical indication|ERCP as per medical indication
16270573|NCT00861185|Drug|senicapoc|Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks)
16270574|NCT00861185|Drug|Placebo|Placebo looks identical to active study medication and will be dosed according to the same dosing regimen
16270575|NCT00861172|Procedure|3T MR scanner|"The follow-up will be scheduled for one year; it will consist in a weekly MR examination during the first two months, and subsequently on the 6th and the 12th months.
~We will perform for each MRI exploration an intravenous injection of contrast agents: gadobutrol (gadovist 1,0 mmol/ml) which is a stable agent with a cyclic structure. This agent is few responsible for NFS, given their low capacity to liberate gadolinium GD3+ in tissues.
~The same imaging protocol will be performed for each MR examination. Evaluation of creatinemia will be used before inclusion and during the 1st, 3rd, 5th, 7th, 9th, and the 10th MRI examination. Thus we will take advantage of catheter to perform the creatinemia blood test and to reduce the discomfort produced by the injection."
16270576|NCT00861146|Behavioral|behavioral counseling plus contingency management|Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
16270577|NCT00861133|Device|Sleuth AT Implantable ECG Monitoring System|The study device provides monitoring only. It cannot provide intervention or treatment.
16270578|NCT00861120|Drug|Pegylated liposomal doxorubicin|40 mg/m2 on day 1 of a 28 days cycle
16270579|NCT00861120|Drug|Panitumumab|6 mg/kg on days 1 and 15 of a 28 days cycle
16270580|NCT00861107|Biological|AlloStim-7|intradermal injection once a week for 3 weeks
16270581|NCT00861107|Procedure|percutaneous tumor cryoablation|ablation of a tumor by percutaneous cryoablation under CT guidance
16270582|NCT00861107|Biological|AlloStim-7|intratumoral injection into cryoablated tumor lesion 1 hour after ablation
16270583|NCT00861107|Biological|AlloStim8 or AlloStim-9|intravenous infusion of AlloStim one week following ablation procedure. First cohort to receive 10^8 cell dose and if no toxicity dose escalates to 10^9 cell dose.
16270584|NCT00861094|Drug|cisplatin|
16270585|NCT00861094|Drug|5-FU|
16270586|NCT00861094|Drug|oxaliplatin|
16270587|NCT00861094|Radiation|radiation therapy|
16270588|NCT00861094|Drug|Folinic Acid|
16270589|NCT00861081|Behavioral|Care Management|Over a period of one year, subjects will participate in two regular stroke clinics, three group clinics, obtain self-management tools, and will receive a series of four scheduled telephone calls by nurse practitioners to review information delivered during the group clinics and help with care coordination. Usual care will also be available.
16270590|NCT00861081|Behavioral|Written Materials|Educational materials about stroke that will be distributed during the group clinic session will be mailed to these subjects. These materials have been developed by the American Heart Association. Usual care will also be available.
16270591|NCT00861068|Drug|SPM927/Lacosamide|SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 600mg/day, intake in the morning and in the evening, intake for 11 weeks
16270592|NCT00861068|Other|Placebo|Placebo tablets two times a day for 10 weeks
16270593|NCT00861042|Drug|SPM927/Lacosamide|SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation
16270594|NCT00861029|Drug|Pazopanib|Subjects treated with pazopanib
16270595|NCT00861029|Other|Placebo for pazopanib|Control for comparison with pazopanib
16270596|NCT00861029|Drug|Moxifloxacin|Comparator for pazopanib
16270597|NCT00861029|Other|Placebo for moxifloxacin|Placebo for moxifloxacin
16270598|NCT00861016|Drug|metoprolol succinate prolonged-release tablet and felodipine|a regimen that starts with metoprolol succinate prolonged-release tablet 47.5mg once daily, orally and allows for dose escalation to 95mg once daily, orally at 4 weeks if not controlled; at week 8 allows for the addition of felodipine sustained release tablet 5mg once daily, orally
16270599|NCT00861003|Device|Medication Event Monitoring System (MEMS)|MEMS is a medication vial cap that electronically records the date and time of bottle opening.
16270600|NCT00860990|Other|Completion of GI quality of life survey|Subjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life.
16270601|NCT00860977|Drug|valacyclovir|oral valacyclovir 500mg twice daily
16270602|NCT00860977|Drug|Placebo|Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
16270603|NCT00860964|Drug|Placebo|Placebo, calcium 900mg/d, VitD200iu/d and exercise
16270604|NCT00860964|Drug|estradiol valerate|estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise
16270605|NCT00860951|Device|Brain Computer Interface Keyboard|Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
16270606|NCT00860938|Drug|Budesonide|After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo
16270607|NCT00860925|Drug|active clonidine|Prior to surgery (goal 2-4 hours) patients will ingest 1 tablet of clonidine (0.2 mg) and will have a transdermal clonidine patch (0.2 mg/day) applied. The patch will be removed at 72 hours after surgery.
16270608|NCT00860925|Drug|active ASA|Prior to surgery (goal 2-4 hours) patients will ingest 2 ASA tablets (81 mg per tablet). After the first dose, patients will ingest 1 tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take ASA orally will receive it rectally.
16270609|NCT00860925|Drug|Clonidine Placebo|Prior to surgery (goal 2-4 hours) patients will take oral clonidine placebo and will have a transdermal placebo patch applied. The patch will be removed at 72 hours after surgery.
16270610|NCT00860925|Drug|ASA Placebo|Prior to surgery (goal 2-4 hours) patients will ingest 2 ASA placebo tablets. After the first dose, patients will ingest 1 placebo tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take placebo orally will receive it rectally.
16270611|NCT00860912|Procedure|Collagen Matrix|surgical/reinforcing material
16270612|NCT00860899|Drug|clonidine, levobupivacaine|One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine [Catapres®, Boehringer Ingelheim, Germany], 7 mL of 0.25% levobupivacaine [Chirocaine®, Abbott S.p.A., Italy] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy.
16270613|NCT00860873|Dietary Supplement|EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)|Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
16270614|NCT00860873|Dietary Supplement|EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)|Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
16270615|NCT00860873|Dietary Supplement|Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)|Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
16270616|NCT00860873|Dietary Supplement|Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)|Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
16270617|NCT00860860|Drug|TF2|TF2: 75-300 mg
16270618|NCT00860860|Drug|IMP-288 labeled with In111 and Lu177|IMP-288: 100 microgram
16270619|NCT00860847|Dietary Supplement|Aged garlic extract and Coenzyme Q10|AGE (1200 mg) and CoQ10 (120 mg)
16270620|NCT00860834|Behavioral|Asthma Coaching Program|Parents will have access to an asthma coach for 12 months. Telephone calls between parents and coaches will occur anywhere from once a week to once a month.
16270621|NCT00860834|Behavioral|Usual Care|Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.
16270622|NCT00860821|Drug|AZD8309|oral solution 30 mg/g, dose: 300mg bid for 3 days
16270623|NCT00860821|Drug|AZD8309|oral solution 30 mg/g, dose: 300mg bid for 3 days
16270624|NCT00860808|Drug|AM-101|Triple intratympanic injection (one on each day 1, 2, and 3)
16270625|NCT00860795|Biological|Echinacea purpurea|Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
16270626|NCT00860795|Drug|placebo|placebo 25 ml daily in 2 divided doses for 10 days
16270627|NCT00860782|Behavioral|Parent Educational Support|Parents will attend 45-minute educational sessions that will focus on providing them with information regarding SCD and how they can best help their child perform better in school.
16270628|NCT00860769|Behavioral|ASHA LIFE|6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
16270629|NCT00860769|Behavioral|USUAL Care|3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting
16270630|NCT00860756|Other|Relaxation CD|A music CD specifically created for this study to promote effective sleep while deployed. It includes sleep instructions tailored to the military deployment environment. The CD includes a voice directed meditation component that helps focus the listener on relaxation in preparation for sleep. The second track is specifically designed music to promote slow breathing and induce sleep.
16270631|NCT00860743|Drug|Antioxidant cocktail|120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.
16270632|NCT00860730|Device|Aortic valve replacement with Perceval aortic heart valve|Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis
16270633|NCT00860717|Procedure|Routine treatment|Subjects from the Control Group received routine treatment, including daily simple dressings with sterile gauze after wound cleaning with a 0.9% physiologic solution, use of 1% hydrophilic silver sulfadiazine cream (Prati Donaduzzi Laboratory, Toledo, Brazil) and orientation about the use of adapted footwear, self-care and the prevention of disabilities. Surgical debridement was done whenever indicated by nursing or orthopedic services from UREMC.
16270712|NCT00860171|Other|Laboratory Biomarker Analysis|Correlative studies
16270713|NCT00860158|Drug|Dasatinib|Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
16270714|NCT00860158|Drug|Leuprolide Acetate (LHRH Analogue)|Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
16270634|NCT00860717|Radiation|Low level laser therapy (LLLT)|"The LLLT equipment was an indium-gallium-aluminnium-phosphide (InGaAlP) semiconductor laser with a maximum output power of 40 mW, continuous radiation emission of visible red light with 660 nm wavelength (+/- 10 nm) and a spot area of 0.04 cm². The energy density used was 4 J per point in the wound edges and 2 J/cm² in the wound bed with a power density of 1 W/cm2.
~Wound beds were irradiated using a scanning technique with no direct contact."
16270635|NCT00860704|Drug|fluidotherapy with ringer-lactate|a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
16270636|NCT00860691|Procedure|Therapeutic conventional colorectal surgery|Patients with colorectal cancer undergo open laparotomy and colorectal resection
16270637|NCT00860691|Procedure|Therapeutic laparoscopic colorectal surgery|Patients with colorectal cancer undergo laparoscopic colorectal resection
16270638|NCT00860691|Other|Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest|Informed consent will be obtained.Blood samples will be obtained at one time point. .Samples will be processed to serum, using a refrigerated centrifuge, then stored at -80C until analysis. Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube.Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fas MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R&D Systems Inc, Minneapolis, USA). Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R&D Systems Inc, Minneapolis, USA).Respiratory burst neutrophil production will be determined quantitatively by flow cytometry using a commercial kit Bursttest Kit (Cat. No: 10-0200; ORPEGEN Pharma, Germany)
16270639|NCT00860678|Other|Physical activity|
16270640|NCT00860678|Other|no Intervention|
16270641|NCT00860652|Radiation|Adjuvant Radiotherapy|Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
16270642|NCT00860652|Radiation|Early Salvage Radiotherapy|Active surveillance with early Salvage RT (SRT). SRT - 64Gy in 32 fractions to the prostate bed. RT should commence no later than 4 months following the first PSA measurement ≥ 0.2ng/mL.
16270643|NCT00860639|Drug|gemtuzumab ozogamycin|gemtuzumab ozogamycin = 6mg/m² during the induction course (Day 4) gemtuzumab ozogamycin = 6mg/m² during the first intensive consolidation course (Day 4)
16270644|NCT00860626|Drug|interferon α plus nucleoside analogue|Standard dose of interferon is used for 12 weeks. On 12th week of treatment, HBV DNA is still detectable (>1000 copies/ml), or HBeAg is still positive. And lamivudine is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.
16270645|NCT00860626|Drug|interferon α|Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is still detectable (>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.
16270646|NCT00860626|Drug|interferon α|Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is undetectable, or HBeAg is negative. And interferon is continued alone for another 9 months.
16270647|NCT00860613|Other|medical nutrition therapy program|the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.
16270648|NCT00860600|Drug|PG2|500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
16270649|NCT00860574|Drug|treosulfan|Given IV
16270650|NCT00860574|Drug|fludarabine phosphate|Given IV
16270651|NCT00860574|Radiation|total-body irradiation|Low dose starting at 2Gy
16270652|NCT00860574|Procedure|peripheral blood stem cell transplantation|Given IV per institutional standard practice
16270653|NCT00860574|Drug|tacrolimus|Given IV or PO
16270654|NCT00860574|Procedure|allogeneic bone marrow transplantation|Given IV per institutional standard practice
16270655|NCT00860574|Procedure|allogeneic hematopoietic stem cell transplantation|Given IV per institutional standard practice
16270656|NCT00860574|Drug|methotrexate|Given IV
16270657|NCT00860548|Drug|currently available therapy in the community|Participants will receive telephone calls every 3 months for approximately 44 months for the purpose of outcome surveys
16270658|NCT00860535|Other|Comparator: Biomarker evaluation|"Patients on standard of care treatment will have blood drawn to evaluate biomarker changes in response to treatment with BCR-ABL inhibitors over a ~3.5 month period.
~Part I will enroll patients who are beginning treatment with imatinib (recommended dose 400 mg every day [qd]), dasatinib (recommended dose 70 mg twice a day [bid]), or nilotinib (recommended dose 400 mg bid).
~Part II will enroll patients who are changing from imatinib therapy to either dasatinib or nilotinib. A decision to initiate Part II will be made based on analysis of the results of Part I."
16270659|NCT00860522|Drug|JVRS-100|Level 1: 0.5 µg/Kg D1,8,15; Level 2: 1.0 µg/Kg D1,8,15; Level 3:2.0 µg/Kg 1,15; Level 4: 2.0 µg/Kg D1,8,15; Level 5: 4.0 µg/Kg D1,15
16270660|NCT00860522|Drug|JVRS-100|Change to Stage 2 with starting dose of 4.0 µg/Kg D1,8,15 if no toxicity level by Level 5.
16270661|NCT00860509|Other|Low Phytosterol and High Phytosterol Diets|Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order
16270662|NCT00860496|Drug|CP- 690,550 and Tacrolimus|10 mg, single dose of CP-690,550 on Day 1 5 mg, every 12 hours of Tacrolimus on Days 1-8 10 mg, single dose of CP-690,550 on Day 8
16270663|NCT00860496|Drug|CP- 690,550 and Cyclosporine|10 mg, single dose of CP-690,550 on Day 1 200 mg, every 12 hours of Cyclosporine on Days 1-6 10 mg, single dose of CP-690,550 on Day 6
16270664|NCT00860483|Other|observational|PET Scan
16270665|NCT00860470|Dietary Supplement|Iron (27 mg) - folic acid (600 ug)|"Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
16270715|NCT00860158|Procedure|Radical Prostatectomy|Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
16270759|NCT00859872|Drug|haloperidol|haloperidol IM injection (5-20mg/d)
16270840|NCT00859183|Drug|Placebo|Placebo oral
16270666|NCT00860470|Dietary Supplement|Multiple micronutrient|"Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
16270667|NCT00860457|Drug|Rituximab|375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
16270668|NCT00860457|Drug|Fludarabine|25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
16270669|NCT00860457|Drug|Lenalidomide|5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
16270670|NCT00860444|Behavioral|Basic Educational and Counseling Program|Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.
16270671|NCT00860444|Behavioral|Comprehensive Educational and Counseling Program|Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. They will also receive 12 months of telephone counseling and a monthly newsletter.
16270672|NCT00860431|Drug|AST-120|6g/day (3 times a day)
16270673|NCT00860418|Behavioral|Pediatric Asthma Alert (PAAL)|Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
16270674|NCT00860418|Behavioral|Standard asthma education|Standard asthma education during 2 home visits.
16270675|NCT00860405|Drug|HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)|Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.
16270676|NCT00860405|Drug|Human serum albumin (HSA 50g/L)|Human serum albumin (HSA 50g/L)
16270677|NCT00860392|Drug|Stable isotope tracer (13-C(4)-BHB)|A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.
16270678|NCT00860379|Drug|Selenium1|2 ug/kg
16270679|NCT00860379|Drug|Selenium2|4 ug/kg
16270680|NCT00860379|Drug|Placebo|IV saline as placebo
16270681|NCT00860366|Drug|Uric Acid|1 gram dissolved in a vehicle containing 500 ml of 0'1% Lithium Carbonate and 5% Mannitol, IV (in the vein), single dose.
16270682|NCT00860366|Other|Vehicle|Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.
16270683|NCT00860353|Drug|AZD2551|Single dose of oral solution.
16270684|NCT00860353|Drug|Placebo|Single dose of oral solution
16270685|NCT00860340|Drug|Spironolactone|100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.
16270686|NCT00860314|Procedure|external electrical cardioversion (with antero-posterior electrode position)|external biphasic electrical cardioversion with step-up-protocol of 50-75-100-150-200 Joules if necessary with antero-posterior electrode position until restoration of normal sinus rhythm
16270687|NCT00860314|Procedure|external electrical cardioversion (with antero-lateral electrode position)|external biphasic electrical cardioversion with step-up protocol of 50-75-100-150-200 Joules if necessary with antero-lateral electrode position until restoration of normal sinus rhythm
16270688|NCT00860301|Other|Acupuncture|Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
16270689|NCT00860288|Drug|Vildagliptin|
16270690|NCT00860288|Drug|Metformin|
16270691|NCT00860288|Drug|Placebo|
16270692|NCT00860288|Drug|Sitagliptin|
16270693|NCT00860275|Drug|BMS-708163|Capsule, Oral, 50 mg, once, Day 1
16270694|NCT00860275|Drug|BMS-708163 + Ketoconazole|(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
16270695|NCT00860275|Drug|Ketoconazole|Tablet, Oral, 400 mg, daily, 16 days
16270696|NCT00860275|Drug|Fluconazole|Tablet, Oral, 1 day 400 mg then 3 days 200 mg
16270697|NCT00860275|Drug|BMS-708163 + Fluconazole|(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
16270698|NCT00860262|Drug|amlodipine|amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
16270699|NCT00860262|Drug|telmisartan|telmisartan 80mg for the 8w, no titration required
16270700|NCT00860262|Drug|telmisartan and amlodipine|telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
16270701|NCT00860249|Behavioral|Letter Only|Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
16270702|NCT00860249|Behavioral|Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
16270703|NCT00860236|Other|Psycoeducation/counseling|2 days of education on mechanisms of illness and coping strategies
16270704|NCT00860236|Behavioral|Cognitive behavioural therapy|4 days intensive training in understanding and behavioural changes
16270705|NCT00860223|Drug|Digoxin|
16270706|NCT00860223|Drug|Neratinib|HKI-272
16270707|NCT00860210|Device|Neurostep™ System|The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
16270708|NCT00860197|Dietary Supplement|Fully torrefied coffee|Fully torrefied coffee
16270709|NCT00860197|Dietary Supplement|Partially torrefied coffee|Partially torrefied coffee
16270710|NCT00860171|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Autologous stem cells given via central catheter
16270716|NCT00860145|Procedure|radiosurgery|The stereotaxic frame will be secured to the skull with four pins. Patients will be taken to the MRI unit and receive a stereotaxic MRI. MRI data will be transferred to the Gamma Knife computer. Each patient will receive radiation to the mesial temporal lobe during a single treatment session. The amygdala and anterior 2cm of the hippocampus as well as the immediately adjacent parahippocampal gyrus will be included in the radiosurgical target. Patients will receive 24Gy to the 50% isodose line using an unlimited number of isocenters. The brainstem and optic nerve plus chiasm will receive less than 10 Gy and 8 Gy, respectively. After treatment, the stereotaxic frame will be removed from the patient's head.
16270717|NCT00860145|Procedure|temporal lobectomy|The temporal lobectomy will be performed under general anesthesia. The superior temporal gyrus will be resected to a minimal degree (typically between 1 and 2cm) and the middle and inferior temporal gyri will be resected to approximately 3cm.The minimum amount of lateral temporal cortex required to perform an aggressive resection of medial temporal structures will be performed. The temporal portion of the amygdala and the anterior two to three cm of the hippocampus will be resected. In addition, nearby entorhinal cortex will be removed.
16270718|NCT00860119|Drug|alprazolam sublingual tablet|1 mg alprazolam sublingual tablet, given as a single dose to each subject
16270719|NCT00860119|Drug|alprazolam oral tablet|1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
16270720|NCT00860106|Other|ED, DDimers and phone follow up|ED score, DDimers level and phone questionnary
16270721|NCT00860093|Other|placebo|After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.
16270722|NCT00860093|Drug|MPC-5971|After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.
16270723|NCT00860080|Drug|PXL01|PXL01 is a synthetic peptide sequentially derived from human lactoferrin. The substance is formulated in a viscous solution of sodium hyaluronate. 10, 20, and 40 mg PXL01 will be administered as an abdominal subcutaneous injection of 0.5, 1, and 2 ml respectively.
16270724|NCT00860080|Drug|Placebo|Placebo is prepared by dilution of sodium hyaluronate using 0.9% sodium chloride solution. The concentration of sodium hyaluronate is 15 mg/ml after dilution. Placebo will be administered as an abdominal subcutaneous injection of 0.5, 1, and 2 ml respectively.
16270725|NCT00860067|Biological|Q/LAIV (MEDI3250)|0.2 mL dose at Day 0
16270726|NCT00860067|Biological|FluMist/B/Yamagata|0.2 mL dose at Day 0
16270727|NCT00860067|Biological|FluMist/B/Victoria|0.2 mL dose at Day 0
16270728|NCT00860054|Dietary Supplement|Different amount of phytosterols are added into diets|Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.
16270729|NCT00860041|Behavioral|pain questionnaires|
16270730|NCT00860028|Drug|Extended Varenicline Pretreatment|4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
16270731|NCT00860028|Drug|Short-term Varenicline Pretreatment|3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
16270732|NCT00860015|Drug|Alimta|"500 mg/m2 via IV over 10 minutes
~A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer."
16270733|NCT00860015|Drug|Gemcitabine|"1000 mg/m2 via IV over 90 minutes
~A nucleoside analog used as chemotherapy."
16270734|NCT00859989|Behavioral|behavioral dietary intervention|
16270735|NCT00859989|Behavioral|exercise intervention|
16270736|NCT00859989|Behavioral|telephone-based intervention|
16270737|NCT00859989|Other|counseling intervention|
16270738|NCT00859989|Other|educational intervention|
16270739|NCT00859989|Other|immunoenzyme technique|
16270740|NCT00859989|Other|laboratory biomarker analysis|
16270741|NCT00859989|Other|questionnaire administration|
16270742|NCT00859989|Other|study of socioeconomic and demographic variables|
16270743|NCT00859989|Procedure|evaluation of cancer risk factors|
16270744|NCT00859989|Procedure|support group therapy|
16270745|NCT00859976|Device|BoneMaster coated acetabular shell.|Bonemaster coated Exceed Acetabular Shell
16270746|NCT00859976|Device|Plasma Coated Acetabular Shell|Plasma HA coated Exceed Acetabular Shell
16270747|NCT00859950|Device|Continuous Positive Airway Pressure (CPAP)|Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.
16270748|NCT00859937|Drug|Dasatinib|Given PO
16270749|NCT00859937|Other|Laboratory Biomarker Analysis|Correlative studies
16270750|NCT00859911|Dietary Supplement|Multiple micronutrients|A tablet on three days a week containing: Vitamin A 1500 µg, Vitamin D 15 µg, Thiamine Mononitrate 1.22 mg, Riboflavin 1.7 mg, Ascorbic Acid 60 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg, Folic Acid 400 µg, Calcium pantothenate 10.8 mg, Cyanocoblamin 6 µg, Vitamin E 18 IU, ferrous sulphate 19 mg, potassium iodide 145 µg, Potassium sulphate 11 mg, Manganese sulphate 0.38 mg, copper sulphate 0.509 mg, zinc sulphate 15 mg
16270751|NCT00859898|Drug|Dapagliflozin|Tablets, Oral, 10 mg, once daily, 24 weeks
16270752|NCT00859898|Drug|Metformin XR|Tablets, Oral, up to 2000 mg, once daily, 24 weeks
16270753|NCT00859898|Drug|Metformin XR|Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
16270754|NCT00859898|Drug|dapagliflozin matching Placebo|Tablets
16270755|NCT00859898|Drug|metformin HCl Modified Release matching Placebo|Tablets
16270756|NCT00859885|Drug|Antithrombotic treatment|antiplatelets, anticoagulants
16270757|NCT00859885|Device|percutaneous device closure of PFO|umbrella device for PFO closure
16270758|NCT00859872|Drug|risperidone oral solution|risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
16270760|NCT00859859|Device|Vagus Nerve Stimulation|"Vagus nerve stimulation for 5 minutes with an oscillatory device (Brookstone) used in previous experimental animal studies for stimulating the vagus nerve on the neck by carotid massage. The oscillatory part of this pen-like device is approximately 0,5 cm2.
~Basic lab tests (metabolic panel and CBC with differential) and monocyte cytokine synthesis and other inflammatory markers will be analyzed."
16270761|NCT00859846|Procedure|Arterial line placement|"The following measures will be collected and compared.
~Time (in seconds) required for successful placement of the arterial line. This is the time elapsed between either palpation or placement of ultrasound probe on the patient's wrist and the successful demonstration of arterial waveform on the anesthesia monitor.
~number of attempts, defined as forward advancements of needle, required to cannulate the artery.
~number of separate skin punctures.
~number of arteries into which entry is attempted."
16270762|NCT00859833|Drug|Adenosine|Myocardial perfusion reserve measured with quantitative MRI during adenosine infusion (0.14 mg/kg/min x 6 minutes).
16270763|NCT00859833|Drug|Regadenoson|Myocardial perfusion reserve measured during regadenoson (0.4 mg/5 ml) bolus administration using quantitative perfusion MRI.
16270764|NCT00859807|Drug|Flavoquine®, Camoquin® Suspension|Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
16270765|NCT00859807|Drug|Flavoquine®, Camoquin® Suspension|Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
16270766|NCT00859794|Other|fMRI|Subjects will undergo MRI scanning to gather data about cognitive functions.
16270767|NCT00859794|Other|Releasing Data|Subjects in the study will be asked to release data about their surgery, and electrostimulation to the research team for analysis.
16270768|NCT00859794|Other|Neuropsychological Testing|Subjects will have a neuropsych evaluation as part of their standard of care for surgery. The research team is asking the subject to release their neuropsych evaluations for analysis.
16270769|NCT00859794|Other|Additional electrode implantation|Subjects normally will have anywhere from 100-200 electrodes implanted as part of their surgery. As part of the study, we would implant additional electrodes that are able to record from smaller, more specific parts of the brain to better understand how your brain is wired.
16270770|NCT00859794|Other|Brain stimulation|Subjects may be asked to undergo additional electrical brain stimulation (in addition to what is required for clinical purposes) to map brain function and epileptogenic areas. This may include extended stimulation mapping, low frequency stimulation (CCEPs), and transcranial stimulation.
16270771|NCT00859781|Drug|177Lu-J591|177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
16270772|NCT00859781|Drug|Ketoconazole|Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
16270773|NCT00859781|Drug|Hydrocortisone|Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
16270774|NCT00859781|Drug|111In-J591|111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
16270775|NCT00859768|Other|Questionnaire administration|The patient receives the SIPP at two different time points during their RT period. The first time point is before the first consultation with the radiotherapist (before starting RT) and the second time point is before the last consultation with the radiotherapist at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care.
16270776|NCT00859755|Drug|ARRY-403, glucokinase activator; oral|single dose, escalating
16270777|NCT00859755|Drug|Placebo; oral|matching placebo
16270778|NCT00859742|Procedure|EBUS-TBNA, integrated PET/CT|EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.
16270779|NCT00859729|Biological|pVAXrcPSAv53l (DNA encoding rhesus PSA)|5 doses, 4 weeks apart
16270780|NCT00859729|Device|DERMA VAX™ intradermal DNA delivery system|in vivo electroporation is applied after each DNA injection
16270781|NCT00859716|Biological|ACE393|ACE393 250 micrograms as intra muscular injection at day 0 and day 21
16270782|NCT00859716|Biological|Placebo vaccine|Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21
16270783|NCT00859703|Drug|Risedronate|35mg oral risedronate once per week for 24 months
16270784|NCT00859703|Drug|Placebo|Placebo 35 mg once a week for 24 months
16270785|NCT00859664|Other|Genotyping of Cytochrome P450|Genotyping of Cytochrome P450
16270786|NCT00859651|Drug|Cholecalciferol|"Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D.
~Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each."
16270787|NCT00859651|Drug|Placebo capsule|Matching placebo capsules
16270788|NCT00859638|Behavioral|Physiotherapy|group self-management classes
16270789|NCT00859638|Behavioral|Occupational Therapy|group self-management classes
16270790|NCT00859638|Behavioral|Capacity Building|workshops and case reviews with primary health care team members
16270791|NCT00859625|Procedure|nurse observation during colonoscope withdrawal|nurse observation during colonoscope withdrawal
16270792|NCT00859599|Device|Monochromatic phototherapy, Biolight®|Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.
16270793|NCT00859599|Device|Monochromatic phototherapy|Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.
16270794|NCT00859586|Device|Miltenyi Magnetic cell sorter for CD3|Receipts will receive 1 x 10 to eighth power CD3 cells/kg of familial haploidentical positively selected cluster of differentiation 34 (CD34)+ stem cells from the same DLI donor.
16270795|NCT00859573|Drug|Modafinil|400 mg/day
16270796|NCT00859573|Drug|Placebo|inactive substance
16270797|NCT00859547|Biological|rThrombin, 1000 IU/mL|rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
16270798|NCT00859534|Drug|afamelanotide|16mg afamelanotide, one dose for the duration of the clincial trial
16270799|NCT00859521|Drug|Levetiracetam|1000 mg Tablet
16270800|NCT00859521|Drug|Keppra®|1000 mg Tablet
16270801|NCT00859508|Device|SyntheCel|Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
16270802|NCT00859508|Device|Other FDA cleared dura replacements|Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
16270803|NCT00859495|Drug|Doxorubicin|A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.
16270804|NCT00859495|Drug|Cisplatin|Platinum-based antineoplastic
16270805|NCT00859495|Drug|Pemetrexed|Folate Analog Metabolic Inhibitor
16270806|NCT00859495|Radiation|Radiotherapy|Standard procedure given 3 weeks after last dose of chemotherapy
16270807|NCT00859469|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV infusion for 2 hours
16270808|NCT00859469|Drug|Gemcitabine|Gemcitabine 1000mg/m2 IV infusion for 90 minutes
16270809|NCT00859456|Drug|Sunitinib|"Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
~A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs)."
16270810|NCT00859430|Drug|Levetiracetam|1000 mg Tablet
16270811|NCT00859430|Drug|Keppra®|1000 mg Tablet
16270812|NCT00859417|Procedure|Traditional surgery|Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).
16270813|NCT00859417|Device|Perigee® prosthesis|Surgical method with Perigee® prosthesis
16270814|NCT00859404|Drug|oglemilast|Tablet oglemilast or placebo once a day, for 12 weeks
16270815|NCT00859378|Device|Cemented semiendoprosthesis|Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)
16270816|NCT00859378|Device|non-cemented|Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)
16270817|NCT00859365|Procedure|Real Acupuncture|Real acupuncture treatment in real acupuncture points
16270818|NCT00859365|Procedure|Placebo Acupuncture|empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator
16270819|NCT00859365|Procedure|No intervention|Patients lay down for a period of 35 minutes without any treatment o intervention
16270820|NCT00859352|Drug|AZD1981|oral tablets during 14 consecutive days.
16270821|NCT00859352|Drug|Midazolam|Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16.
16270822|NCT00859339|Drug|Gemcitabine|Gemcitabine ( 1000 mg/m2) IV days 1 and 8
16270823|NCT00859339|Drug|Cisplatin|Cisplatin (70 mg/m2) IV day 1
16270824|NCT00859339|Drug|Sunitinib Malate|Sunitinib malate (37.5 mg) oral daily for days 1-14
16270825|NCT00859339|Procedure|Radical Cystectomy|Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
16270826|NCT00859313|Drug|Sufentanil NanoTab PCA System/15 mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
16270827|NCT00859300|Genetic|Blood sample|Blood sample Determination of genetic background
16270828|NCT00859300|Genetic|Blood sample|Blood sample Determination of genetic background
16270829|NCT00859274|Drug|budesonide|Budesonide is given via inhalation utilising a dry powder inhaler called Easyhaler. The dosage is 400 ug twice daily. The duration of the study is 12 weeks but very probably the patients continue the usage of this drug as a part of their routine clinical management.
16270830|NCT00859261|Procedure|Experimental 3D Breast Ultrasound imaging|Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete.
16270831|NCT00859261|Procedure|Experimental Photoacoustic Imaging|Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete.
16270832|NCT00859235|Drug|Chlorhexidine gluconate 0.2%|Mouth wash prior to procedure
16270833|NCT00859235|Other|Plain water|Mouth wash prior to procedure
16270834|NCT00859222|Drug|LBH589|
16270835|NCT00859222|Drug|bevacizumab|
16270836|NCT00859196|Drug|Dexpanthenol (BAY81-2996)|Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.
16270837|NCT00859196|Drug|Placebo|Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.
16270838|NCT00859183|Drug|Sirolimus|cumulative loading dose of 8 mg of oral sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days
16270839|NCT00859183|Drug|Sirolimus|cumulative loading dose of 24 mg of oral sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days
16270841|NCT00859170|Device|Accordion device|an antiretropulsion device
16270842|NCT00859157|Procedure|therapeutic conventional surgery|Patients undergo tumescent or standard mastectomy
16270843|NCT00859144|Behavioral|Be Proud! Be Responsible!|This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.
16270844|NCT00859144|Behavioral|Becoming A Responsible Teen (BART)|This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.
16270845|NCT00859144|Behavioral|Reducing the Risk|This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.
16270846|NCT00859131|Drug|Rabbit Antithymocyte globulin|1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
16270847|NCT00859131|Drug|Daclizumab|1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
16270848|NCT00859118|Drug|AG-013736|Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only)
16270849|NCT00859118|Drug|AG-013736|Axitinib 5 mg PO BID x ~2 weeks (12-14 days), followed by 1 week drug break (for cycle 1 only). After Scan#3 obtained, patients will commence with Axitinib 5 mg PO BID continuously without breaks, repeated in 3 week cycles.
16270850|NCT00859105|Drug|Imiquimod 5%: manufactured by Apotex|Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
16270851|NCT00859105|Drug|Adara 5% Cream US|Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
16270852|NCT00859105|Drug|Adara 5% Cream Canada|Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
16270853|NCT00859105|Drug|Imiquimod Vehicle|Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
16270854|NCT00859092|Dietary Supplement|Simply Thick|Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency
16270855|NCT00859079|Drug|GLP-1|Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
16270856|NCT00859079|Drug|Human regular insulin intravenously|Human regular insulin intravenously according to the Munich-registry.
16270857|NCT00859053|Drug|BMS-790052|Capsules, Oral, 30 mg, single dose, one day
16270858|NCT00859040|Drug|SOM230C|Injection in the buttocks every 28 days
16270859|NCT00859027|Drug|risedronate|35 mg/week by mouth
16270860|NCT00859027|Drug|Placebo risedronate oral tablet|One tablet by mouth every week as directed
16270861|NCT00859014|Biological|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells
16270862|NCT00859001|Drug|FM+R|Fludarabine-Mitoxantrone-Rituximab
16270863|NCT00859001|Drug|Zevalin (Ibritumomab Tiuxetan)|
16270864|NCT00858988|Drug|Rifaximin|100mg of rifaxin for 7 consecutive days, twice daily
16270865|NCT00858988|Drug|Placebo|twice daily for 7 consecutive days
16270866|NCT00858975|Procedure|cryotherapy|Placing 4-6 cryotherapy probes into the renal tumors and conducting two cycles of freezing and thawing
16270867|NCT00858962|Drug|Raltegravir|400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.
16270868|NCT00858936|Drug|IK-1001|6 escalating dose levels of 0.2, 0.5, 0.75, 1.0, 1.25, and 1.5 mg/kg/hr infusion for 6 hours
16270869|NCT00858936|Drug|Normal Saline|6 escalating dose levels of 0.2, 0.5, 0.75, 1.0, 1.25, and 1.5 mg/kg/hr infusion for 6 hours
16270870|NCT00858923|Device|Energex HemoModulator|To use ultraviolet light to reduce HIV virus in the patient's blood
16270871|NCT00858910|Other|Motor imagery (MI) training|MI training encloses the internal rehearsal of a known motor skill without any overt motor output.
16270872|NCT00858910|Other|Control intervention|"The control intervention encloses relaxation and breathing exercises, and information about:
~the disease (stroke),
~therapy options,
~self-help groups and their offers for support,
~helping aids for independent living at home."
16270873|NCT00858897|Other|Cysteine isotope infusion at normoglycemia vs hyperglycemia|L-[3,3-2H2]cysteine
16270874|NCT00858897|Drug|Regular Insulin|Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
16270875|NCT00858884|Other|Clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain|All participating subjects (patients with and without neuropsychiatric SLE and healthy controls) will undergo clinical and laboratory evaluations, transesophageal echocardiography, carotid duplex, transcranial duplex, and magnetic resonance of the brain
16270876|NCT00858871|Drug|Brivanib|Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
16270877|NCT00858871|Drug|Placebo|Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
16270878|NCT00858871|Drug|Sorafenib|Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
16270879|NCT00858871|Drug|Placebo|Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity
16270880|NCT00858858|Drug|Ursodeoxycholic Acid|8 weeks of oral UDCA treatment 10 mg/kg qd
16270881|NCT00858845|Drug|Clonidine Patch|A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.
16270882|NCT00858845|Other|Matching Placebo Patch|A matching placebo patch to be worn for a period of 3 months.
16270883|NCT00858832|Drug|Methergine|Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
16270884|NCT00858806|Drug|Imatinib|"Intermittent Imatinib administration.
~1 week on / 1 week off for the 1st month(weeks 1-4)
~2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12)
~1 month on / 1 month off from the 4th month thereafter (weeks 13 on)"
16270885|NCT00858793|Procedure|PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)|Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.
16270886|NCT00858780|Drug|Etanercept|50 mg etanercept once weekly + methotrexate
16270887|NCT00858780|Drug|Etanercept|25mg etanercept once weekly + methotrexate
16270888|NCT00858780|Drug|Placebo|Placebo comparator once weekly + methotrexate
16270889|NCT00858767|Dietary Supplement|menaquinone-7 from casein capsules|90 µg menaquinone-7 daily during 8 weeks
16270890|NCT00858767|Dietary Supplement|menaquinone-7 from arabic gum capsules|90 µg menaquinone-7 daily during 8 weeks
16270891|NCT00858767|Dietary Supplement|menaquinone-7 from linseed oil capsules|90 µg menaquinone-7 daily during 8 weeks
16270892|NCT00858754|Drug|methylnaltrexone|
16270893|NCT00858754|Drug|placebo|
16270894|NCT00858741|Radiation|single fraction|8 Gy x 1 fraction to 8 Gy total dose in single dose.
16270895|NCT00858741|Radiation|multiple fractions|3.0 Gy x 10 fractions to 30.0 Gy total dose in two weeks.
16270896|NCT00858728|Behavioral|5 portions|Subjects randomised to the intervention group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 5 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).
16270897|NCT00858728|Behavioral|2 portions|Subjects randomised to the control group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 2 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).
16270898|NCT00858715|Drug|aspirin|100 mg aspirin
16270899|NCT00858715|Drug|clopidogrel|75 mg (Arm 1) and 150 mg (Arm 2)
16270900|NCT00858702|Drug|olmesartan medoxomil and a CCB|olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
16270901|NCT00858702|Drug|olmesartan medoxomil and a diuretic|olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
16270902|NCT00858689|Drug|Minocycline|50-100 mg PO BID for 8 weeks with an option for a 1 year extension.
16270903|NCT00858676|Drug|acarbose|50mg acarbose 3 times a day PO. duration: one year
16270904|NCT00858663|Radiation|intensity modulated radiation therapy|"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.
~Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.
~Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan."
16270905|NCT00858663|Drug|RAD001 (everolimus) + Cisplatin|"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.
~Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.
~Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan."
16270906|NCT00858650|Other|Standard of Care|Standard of care may or may not include use of testosterone replacement therapy
16270907|NCT00858637|Drug|MCI-196|Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
16270908|NCT00858637|Drug|Placebo of Simvastatin|Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
16270909|NCT00858637|Drug|Simvastatin|Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
16270910|NCT00858637|Drug|Placebo of MCI-196|Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
16270911|NCT00858624|Drug|ketamine|Administration of low dose intravenous ketamine. Dose: 0.075mg/kg over 10 minutes followed by 0.005mg/kg/min over 20 minutes. Given as single infusion.
16270912|NCT00858611|Drug|VRC-FLUDNA047-00-VP|
16270913|NCT00858611|Drug|Flulaval (Registered) Seasonal Influenza Vaccine|
16270914|NCT00858572|Drug|STA-9090 (ganetespib)|Chemotherapy agent
16270915|NCT00858559|Device|Implantable cardioverter defibrillator with Home Monitoring function|Implantable cardioverter defibrillators can send data from its diagnostic and therapy memory via wireless Home Monitoring on a daily basis to an internet based platform, securely accessed by the attending physician
16270916|NCT00858559|Device|Standard implantable cardioverter defibrillator|Implantable cardioverter defibrillators used as standard devices without Home Monitoring
16270917|NCT00858546|Device|Repetitive transcranial stimulation|Repetitive transcranial stimulation
16270918|NCT00858533|Behavioral|Health at Work workplace health advice and support|The intervention group will receive additional support from a H@W Workplace Health Advisor who will deliver an intervention aimed at sickness absence prevention or sustained return to work, depending on individual circumstances. The intervention will be standardized as far as possible to show types of activity undertaken with participants, their GP, line managers, human resources departments and trade union representatives.
16270919|NCT00858507|Behavioral|RN Brief Intervention|RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community
16270920|NCT00858507|Behavioral|Social Worker Outreach|Social worker will encounter homeless veteran in the community and encourage to come to the VA for care
16270921|NCT00858494|Drug|Hyland's Cold 'n Cough 4 Kids|Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days
16270922|NCT00858481|Drug|Spinosad Creme Rinse - Vehicle Control|One or two, 10-minute topical applications (7 days apart)
16270923|NCT00858481|Drug|Spinosad Creme Rinse|0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
16270924|NCT00858481|Drug|Spinosad Creme Rinse|1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
16270925|NCT00858481|Drug|Spinosad Creme Rinse|2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
16270926|NCT00858468|Biological|Influenza virus vaccine (2004-2005 Formulation)|0.25 mL, Intramuscular
16270927|NCT00858468|Biological|Influenza virus vaccine (2004-2005 Formulation)|0.25 mL, Intramuscular
16270928|NCT00858455|Drug|GSK1349572 and MaaloxAdvanced Maximum Strength|A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength
16270929|NCT00858455|Drug|GSK1349572 and Maalox Advanced Maximum Strength|A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength
16270930|NCT00858455|Drug|GSK1349572 and One A Day|A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin
16270931|NCT00858455|Drug|GSK1349572|A single dose of GSK1349572
16270932|NCT00858442|Procedure|With PRP|Release of burn contractures and skin graft on the affected limb, a rigorous haemostasis. The surgeon must distribute the activated PRP evenly, forming a very fine clot over it. Immediately the split skin graft must be applied, duly fenestrated. The grafted zone will be measured in it's longest width and length, taking a standardized photograph. On the 5th day the nurse will evaluate the graft's conditions. The evaluation will be done following a previously established follow-up protocol. Measurements of width & length of graft and standardized photo taken at the initiation of the compressive system. Measurement of graft's width & length and standardized photo at the end of the compressive system according protocol. Statistical analysis.
16270933|NCT00858429|Drug|capecitabine|1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.
16270934|NCT00858429|Radiation|yttrium Y 90 glass microspheres|The amount of radioactivity required to deliver the desired dose to the liver is calculated using a formula. The dose depends on the cohort upon which the patient is enrolled. Y90 is administered during Cycle #2 on days 1-7.
16270935|NCT00858416|Device|"Kineticure System followed by sham"|20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device
16270936|NCT00858416|Device|"sham followed by Kineticure System"|sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
16270937|NCT00858403|Drug|Dasatinib|Take tablets of Dasatinib by mouth once a day.
16270938|NCT00858390|Dietary Supplement|enteral feeding with Oxepa® and Glutasolve®|enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®
16270939|NCT00858377|Drug|Arm 1- Dose Escalation|AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
16270940|NCT00858377|Drug|Arm 1- Dose Expansion|AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
16270941|NCT00858364|Drug|Darbepoetin alfa|Administered subcutaneously once every 3 weeks
16270942|NCT00858364|Drug|Placebo|Administered subcutaneously once every 3 weeks
16270943|NCT00858351|Behavioral|Thermal Biofeedback Assisted Relaxation|6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.
16270944|NCT00858351|Behavioral|Discussion with therapist|6 sessions, 25 minutes each, discussing topics with a therapist.
16270945|NCT00858338|Procedure|Potentially curative surgery|"Surgery:
~Week 1: Potentially curative surgery. If the tumor successfully resected (microscopically disease-free margins, Ro, with regional lymphadenectomy for proper staging), the ip catheter in place.
~Weeks 2-4: Recovery. Then continue to adjuvant IP chemotherapy."
16270946|NCT00858338|Drug|Floxuridine (IP)|"Adjuvant IP Chemotherapy:
~week 1: ip Floxuridine 3 gm/day, days 1,2,3. week 2: 1 week without treatment. week 3: ip Floxuridine 3 gm/day protocol days 15,16,17. week 4: 1 week without treatment. Then continue to chemoradiation therapy."
16270947|NCT00858338|Procedure|Adjuvant Chemoradiation therapy|"Adjuvant Chemoradiation therapy:
~week 1: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-4; week 9: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-3; week 14: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; week 19: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days."
16270948|NCT00858325|Drug|Daptomycin|4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
16270949|NCT00858312|Other|high dairy diet|12 week energy restriction with 3-4 servings of dairy foods/day.
16270950|NCT00858312|Other|Low Dairy|less than 1 serving of dairy foods per day.
16270951|NCT00858299|Drug|valsartan|160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks
16271038|NCT00857571|Drug|750 mg Suspension|Single oral dose of 750 mg of PF-02413873 suspension
16270952|NCT00858286|Other|Spirometry, PEF measurements and diary cards to evaluate control of Asthma|No intervention is made with the existing therapy, but patient will perform spirometry and PEF evaluations together with a registration of control of asthma in diary cards and health economic parameters in questionnaires
16270953|NCT00858273|Dietary Supplement|Antioxidant supplement|1 capsule daily with dinner
16270954|NCT00858273|Other|Diabetes treatment|Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator
16270955|NCT00858273|Drug|Regular Insulin|Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
16270956|NCT00858260|Genetic|blood sample|Searching for Klotho variants in DNA
16270957|NCT00858247|Dietary Supplement|Vitamin D3|One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.
16270958|NCT00858234|Drug|Vorinostat|Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.
16270959|NCT00858234|Drug|Bortezomib|Bortezomib (1.0 or 1.3 mg/m^2) intravenous infusion.
16270960|NCT00858208|Drug|pegaptanib sodium|pegaptanib sodium intravitreal injection every 6 weeks for 2 years
16270961|NCT00858195|Drug|Indomethacin 75mg Extended-Release Capsules, Sandoz|
16270962|NCT00858195|Drug|Indocin 75mg SR Capsules|
16270963|NCT00858182|Drug|PD solution for nocturnal exchanges|Instillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks.
16270964|NCT00858182|Drug|PD solution for diurnal exchanges|Instillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks.
16270965|NCT00858156|Drug|BG9928|Oral 75 mg single dose
16270966|NCT00858143|Other|Non Interventional Observation|Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
16270967|NCT00858130|Device|VeinOPlus|The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.
16270968|NCT00858117|Biological|Alemtuzumab|Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks
16270969|NCT00858117|Biological|Rituximab|Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks
16270970|NCT00858104|Procedure|Percutaneous Laser Ablation|Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.
16270971|NCT00858065|Behavioral|Strengthening Families Program (SFP)|Prevention program with 7 weekly group sessions for parent and child.
16270972|NCT00858065|Behavioral|Family Matters|Prevention program with 4 booklets for families to do at home with their child.
16270973|NCT00858052|Device|Saline-filled breast implant [IDEAL IMPLANT (R)]|Breast augmentation
16270974|NCT00858026|Other|Breastmilk|Exclusively breastfed babies
16270975|NCT00858026|Other|Standard milk|Weaning babies fed with the standard formula
16270976|NCT00858026|Other|Fermented milk|Weaning babies fed with the fermented formula
16270977|NCT00858013|Drug|Nateglinide|Nateglinide 90~120mg three times a day
16270978|NCT00858013|Drug|Glimepiride|Glimepiride 1~2mg once a day
16270979|NCT00858000|Other|Retrospective analysis of already archived samples|RNA extracted from tissue samples already archived
16270980|NCT00857987|Drug|EMS Expectorant|Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.
16270981|NCT00857987|Other|Placebo|Vehicle
16270982|NCT00857974|Other|Physical Activity|The intervention is an individualized, structured, moderate intensity home-based physical activity program. During the first 12 weeks the program will focus on lower extremity strengthening, and thereafter incorporate cardiovascular activity. The target duration of activity is 150 minutes per week, i.e., 20-30 min on most days of the week. However, the program is adjusted based on each participant's progression, initial level of physical fitness and will be modified in response to illness, injury, or physical symptoms.
16270983|NCT00857961|Drug|Testosterone MD-Lotion|Administered Topically
16270984|NCT00857948|Drug|ivermectin treatment conditioner|Application followed by thorough rinsing of the hair and scalp with water.
16270985|NCT00857948|Drug|Placebo, vehicle control|Application followed by thorough rinsing of the hair and scalp with water.
16270986|NCT00857935|Drug|NatrOVA Creme Rinse - 1%|NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
16270987|NCT00857935|Drug|NIX Creme Rinse - 1% permethrin|NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)
16270988|NCT00857922|Other|tissue and data repository|Tissue and data will be maintained in a repository for study from consenting subjects.
16270989|NCT00857909|Drug|Amiloride|1 tablet twice a day
16270990|NCT00857909|Drug|Spironolactone|1 tablet twice a day
16270991|NCT00857909|Drug|Placebo|Placebo
16270992|NCT00857909|Drug|Placebo and spironolactone|5mg twice daily
16270993|NCT00857909|Drug|Spironolactone|25mg twice daily
16270994|NCT00857896|Drug|Fesoterodine|4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
16270995|NCT00857883|Drug|GSK1521498 or placebo|GSK1521498 is a mu-opioid receptor inverse agonist
16271039|NCT00857571|Drug|150 mg Tablet|Single oral dose of 150 mg of PF-02413873 tablets
16271040|NCT00857571|Drug|30 mg Tablet|Single oral dose of 30 mg of PF-02413873 tablets
16271041|NCT00857571|Drug|400 mg Tablet|Single oral dose of 400 mg of PF-02413873 tablets
16271042|NCT00857571|Drug|5 mg Tablet|Single oral dose of 5 mg of PF-02413873 tablets
16271043|NCT00857571|Drug|750 mg Tablet|Single oral dose of 750 mg of PF-02413873 tablets
16271044|NCT00857558|Drug|saxagliptin|orally administration at 1 mg once a day for 12 weeks
16270996|NCT00857870|Drug|Metformin|"Metformin is administered as coated tablet. Initial dose is 500 mg twice a day (morning and evening) during or after the meal. The first administration takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c.
~Initial dose of 500 mg bid was increased after 4 weeks (visit 2) to 850 mg bid when the patient tolerated the initial dose. If the side effects were not tolerable, the initial dose was decreased to 500 mg once a day and where appropriate increased at a later visit.
~After 8 weeks (visit 3) metformin dose was increased to 1000 mg bid when tolerated. If dose is not tolerated, it was decreased to the next lower dose."
16270997|NCT00857870|Drug|Insulin glargine|Insulin glargine is given subcutaneously with an insulin-pen (SoloStar®). The dose was titrated to reach a fasting plasma glucose value of <5.6 mmol/l. Insulin glargine was given once a day in the evening before going to bed (bed-time injection). The first insulin injection takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c. All patients were trained in handling and storage of the insulin-pen.
16270998|NCT00857857|Drug|GW870086X|Investigational product
16270999|NCT00857857|Drug|FP|Positive control
16271000|NCT00857857|Drug|Placebo|Placebo control
16271001|NCT00857831|Dietary Supplement|Vitamin D and Calcium|2000 IU/day Vitamin D3 (cholecalciferol) and 1.3 g/day calcium carbonate will be taken for 15-20 weeks.
16271002|NCT00857818|Drug|Aripiprazole|Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks
16271003|NCT00857818|Drug|Oanzapine, risperidone, or quetiapine|Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks
16271004|NCT00857805|Procedure|Transarterial Chemoembolization|Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
16271005|NCT00857805|Radiation|Proton Beam Radiotherapy|Fifteen consecutive sessions
16271006|NCT00857792|Drug|regadenoson|Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
16271007|NCT00857779|Biological|subcutaneous immunotherapy|7 injections
16271008|NCT00857766|Drug|ADVAIR DISKUS™ 250/50mcg|ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
16271009|NCT00857766|Other|Placebo|COPD subjects-Placebo DISKUS
16271010|NCT00857753|Drug|Fentanyl patch 25 ug/nr Sandoz|
16271011|NCT00857753|Drug|Duragesic|
16271012|NCT00857740|Behavioral|Education|Education about the neurophysiology of pain
16271013|NCT00857727|Drug|Dexmedetomidine|Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg
16271014|NCT00857727|Drug|Saline|Given by a continuous infusion
16271015|NCT00857714|Drug|lapatinib|1500 mg lapatinib for 14-21 days
16271016|NCT00857701|Device|Knee Extension Dynasplint|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.
16271017|NCT00857688|Drug|Bismu-Jet|Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride
16271018|NCT00857688|Other|Placebo|Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water
16271019|NCT00857675|Drug|AAAA|Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
16271020|NCT00857675|Drug|AAPA|Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
16271021|NCT00857675|Drug|PAAA|Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
16271022|NCT00857662|Device|Onyx|Embolization
16271023|NCT00857662|Device|TRUFILL|Embolization
16271024|NCT00857649|Drug|Memantine|20 mg Oral Tablets Once Daily
16271025|NCT00857649|Drug|Placebo|Oral Tablets Once Daily
16271026|NCT00857636|Behavioral|Health literacy, health message|The intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers.
16271027|NCT00857623|Drug|AZD2066|Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
16271028|NCT00857623|Drug|Placebo|Capsule, once daily
16271029|NCT00857597|Procedure|Transoral Incisionless Fundoplication|The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
16271030|NCT00857597|Drug|Proton Pump Inhibitors; active control|Proton Pump Inhibitors; active control
16271031|NCT00857584|Drug|Extended release quetiapine (quetiapine XR)|"Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
~Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study."
16271032|NCT00857584|Drug|Sertraline|"Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
~Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study."
16271033|NCT00857584|Drug|adequate mood stabilizer|An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).
16271034|NCT00857571|Drug|150 mg Suspension|Single oral dose of 150 mg of PF-02413873 suspension
16271035|NCT00857571|Drug|30 mg Suspension|Single oral dose of 30 mg of PF-02413873 suspension
16271036|NCT00857571|Drug|400 mg Suspension|Single oral dose of 400 mg of PF-02413873 suspension
16271037|NCT00857571|Drug|5 mg Suspension|Single oral dose of 5 mg of PF-02413873 suspension
16271045|NCT00857558|Drug|saxagliptin|orally administration at 2.5 mg once a day for 12 weeks
16271046|NCT00857558|Drug|saxagliptin|orally administration at 5 mg once a day for 12 weeks
16271047|NCT00857558|Drug|placebo|orally administration once a day for 12 weeks
16271048|NCT00857545|Other|Laboratory Biomarker Analysis|Correlative studies
16271049|NCT00857545|Biological|Polyvalent Antigen-KLH Conjugate Vaccine|Given SC
16271050|NCT00857545|Biological|Saponin-based Immunoadjuvant OBI-821|Given SC
16271051|NCT00857532|Drug|florbetapir F 18|10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection
16271052|NCT00857519|Drug|Melphalan, Carboplatin|Intra-arterial chemotherapy.
16271053|NCT00857506|Drug|florbetapir F 18|370 Mega Becquerel (10 mCi)
16271054|NCT00857493|Biological|IMVAMUNE|Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
16271055|NCT00857493|Biological|IMVAMUNE|One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
16271056|NCT00857480|Drug|NRL972|Single intravenous administration of 2 mg NRL972
16271057|NCT00857480|Drug|NRL972|Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.
16271058|NCT00857480|Drug|NRL972|Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
16271059|NCT00857467|Drug|NRL001|Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 1 g rectal suppository, with a 7-day washout period between dosing.
16271060|NCT00857467|Drug|NRL001|Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository, with a 7-day washout period between dosing.
16271061|NCT00857454|Drug|Testosterone MD-Lotion|30 mg to 120 mg administered topically once daily for 60 days
16271062|NCT00857441|Device|Drug eluting balloon|Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
16271063|NCT00857441|Device|Liberté|Bare metal stent
16271064|NCT00857441|Device|PTCA balloon catheter|Percutaneous transluminal coronary angioplasty catheter
16271065|NCT00857441|Device|Taxus|Paclitaxel eluting stent
16271066|NCT00857428|Drug|oxymorphone|Tablets
16271067|NCT00857428|Drug|Oxymorphone|40 mg tablets
16271068|NCT00857415|Drug|florbetapir F 18|Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
16271069|NCT00857402|Dietary Supplement|Peanuts|30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.
16271070|NCT00857402|Dietary Supplement|Daboqolo|30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
16271071|NCT00857389|Drug|Thiotepa|5 mg/kg through a central venous catheter (CVC) over 2 hours on Day -8.
16271072|NCT00857389|Drug|Clofarabine|40 mg/m^2 through a central venous catheter (CVC) over 1 hour daily on 4 consecutive days (Days -6 through -3).
16271073|NCT00857389|Drug|Busulfan|"Test dose of 0.5 mg/kg through a central venous catheter (CVC)over 30 minutes on Day -7.
~High dose 5,000 µMol-min through a central venous catheter (CVC) over 3 hours on Days -5, -4, and -3."
16271074|NCT00857389|Procedure|Allogeneic Stem Cell Transplantation|Infusion of stem cells through through a central venous catheter (CVC) On Day 0.
16271075|NCT00857389|Drug|Thymoglobulin (ATG)|1.25 mg/kg by vein on Day -4 and 1.75 mg/kg on Day -3.
16271076|NCT00857389|Drug|G-CSF (Filgrastim)|5 µg/kg Injection under the skin once a day, starting 1 week after transplant, until blood cell levels return to normal.
16271077|NCT00857389|Drug|Tacrolimus|Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered as indicated after transplant day 90, if no GVHD is present. Tacrolimus is adjusted trough level of 5-15 ng/mL.
16271078|NCT00857389|Drug|Methotrexate|5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. The Day 11 methotrexate dose may be held as indicated if mucositis is present.
16271079|NCT00857389|Drug|Cyclophosphamide|Post haploidentical stem cell transplant participants: 50 mg/kg by vein on Days + 3 and + 4.
16271080|NCT00857389|Drug|Mesna|Post haploidentical stem cell transplant participants: 10 mg/kg by vein just prior to the first dose of cyclophosphamide, repeated every 4 hours for a total of ten (10) doses.
16271081|NCT00857376|Dietary Supplement|Alpha lipoic acid at 3 doses compared to placebo|This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.
16271082|NCT00857324|Drug|Vorinostat|"Patients will start induction treatment with a standard dose of MP and escalating doses of Vorinostat:
~Melphalan 0.18 mg/Kg for 4 days; Prednisone 1.5 mg/Kg for 4 days. Each cycle will be repeated every 28 days for a total of 6 courses
~In the first part of the study, the standard oral MP will be combined with escalating doses of Vorinostat.
~Level -1 Vorinostat = 100 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4
~Level 0 Vorinostat = 200 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4
~Level +1 Vorinostat = 300 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4
~Level +2 Vorinostat = 400 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4"
16271083|NCT00857311|Biological|MRKAd5 HIV-1 gag vaccine (V520)|3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
16271084|NCT00857311|Biological|Comparator: Placebo|1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
16271085|NCT00857311|Biological|Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed|0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
16271086|NCT00857311|Biological|MRKAd5 HIV-1 gag vaccine (V520)|3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
16271087|NCT00857298|Behavioral|Dietary Intervention|The nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be ~750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets.
16271088|NCT00857285|Drug|olmesartan medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
16271089|NCT00857285|Drug|losartan potassium|losartan oral tablets, once daily for up to 12 weeks
16271090|NCT00857272|Drug|PEG electrolyte lavage solution + bisacodyl - reformulation|multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
16271091|NCT00857272|Drug|PEG electrolyte lavage solution + bisacodyl|multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
16271092|NCT00857259|Drug|Everolimus|5 mg oral tablet
16271093|NCT00857259|Drug|Ranibizumab|0.5 mg administered by intravitreal injection
16271094|NCT00857246|Drug|Cetuximab|
16271095|NCT00857246|Drug|Irinotecan|
16271096|NCT00857246|Drug|Cisplatin|
16271097|NCT00857246|Procedure|Surgery|
16271098|NCT00857246|Drug|5-FU|
16271099|NCT00857246|Radiation|Radiation|
16271100|NCT00857233|Drug|Memantine|20 mg oral tablets once daily
16271101|NCT00857220|Drug|eszopiclone|One 2 mg tablet per day for 12 months
16271102|NCT00857220|Drug|eszopiclone|one 3mg tablet per day for 12 months
16271103|NCT00857207|Behavioral|Goal Management Training|Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
16271104|NCT00857194|Procedure|2 hour Oral Glucose Tolerance Test|Fasting baseline blood samples will be drawn for analysis of insulin and glucose. A 75-gram glucose solution will be administered and subjects remain sedentary for 2 hours. After 2 hours, blood is drawn to analyze post-load insulin and glucose levels.
16271105|NCT00857194|Procedure|Fat Meal Test|A fasting blood draw is performed for analysis of lipids, insulin, and glucose. Subjects ingest a high fat meal (milkshake made from heavy whipping cream and premium ice cream) within 15 minutes. Postprandial blood draws at 2, 4, and 6 hours are made for analysis of lipids, insulin, and glucose.
16271106|NCT00857168|Drug|Testosterone MD-Lotion|
16271107|NCT00857155|Other|Clopidogrel withdraw prior to CABG|Patients on clopidogrel are stratified into time-based platelet function recovery groups as determined by point of care methods and based on these groups clopidogrel is withdrawn at a pre-specified timepoint before surgery.
16271108|NCT00857142|Drug|oxymorphone hydrochloride|
16271109|NCT00857142|Drug|Opana|
16271110|NCT00857129|Procedure|Normal Unit|low-risk patients randomised to Normal Unit
16271111|NCT00857129|Procedure|Special birth unit|Low-risk women are randomised to the Special birth unit. Organised to take care of women with extended need for surveillance before, under and after birth.
16271112|NCT00857116|Drug|Albendazole|Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
16271113|NCT00857116|Drug|Placebo|Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
16271114|NCT00857103|Behavioral|CHOICE|Use of Choice support system as preparation for patient consultations
16271115|NCT00857090|Drug|OMS201|"Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery
~Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery"
16271116|NCT00857090|Drug|Vehicle|Stages 1-2: Vehicle irrigation solution during surgery
16271117|NCT00857077|Drug|Sulfadoxine-pyrimethamine|
16271118|NCT00857077|Drug|Placebo|
16271119|NCT00857051|Other|Hotline Service|A 24 hour hotline to answer questions about baby care or mother self-care. Hotline will be answered by a midwife and answers will be based on algorithms.
16271120|NCT00857051|Other|Film|A DVD addressing common stressors in the early postpartum.
16271121|NCT00857038|Drug|Doxycycline|Doxycycline tablets, 100mg daily
16271122|NCT00857038|Drug|Placebo|Placebo tablets 100mg
16271123|NCT00857025|Biological|beta-glucan MM-10-001|Dose escalation with six patients treated at each of the following oral dosages: 2.5, 5.0, 7.5, 10, 15, 20, 30, 40, 50, and 80 mg/day
16271124|NCT00857025|Other|flow cytometry|Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and every 4 weeks until the end of study treatment.
16271125|NCT00857025|Other|laboratory biomarker analysis|Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and at the end of study treatment.
16271126|NCT00857025|Other|questionnaire administration|Assessment pre-study and week 5, week 9, week 13 and at off study.
16271127|NCT00856999|Drug|Botox|Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
16271128|NCT00856986|Drug|liraglutide|Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
16271129|NCT00856986|Drug|insulin detemir|Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm
16271130|NCT00856986|Drug|metformin|Metformin tablets, at least 1500 mg/day
16271131|NCT00856973|Drug|eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
16271132|NCT00856973|Drug|eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
16271133|NCT00856973|Drug|Placebo|1 tablet per day for 12 weeks
16271134|NCT00856960|Drug|Aliskiren|Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.
16271135|NCT00856960|Drug|Aliskiren|Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period.
16271136|NCT00856960|Drug|Comparator: Losartan|Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.
16271137|NCT00856960|Drug|Comparator: Placebo to Aliskiren|Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
16271138|NCT00856960|Drug|Comparator: Placebo to Losartan|Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
16271139|NCT00856947|Dietary Supplement|Cholecalciferol D3|2 tablets of 1200 IU daily from week 24 of gestation to 1 week after delivery
16271140|NCT00856947|Other|Placebo tablet|2 tablets containing no active substance
16271141|NCT00856934|Biological|Autologous Platelet Rich Plasma|Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.
16271142|NCT00856934|Biological|Keratinocyte suspension|Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.
16271143|NCT00856934|Other|Standard dressings|Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
16271144|NCT00856908|Drug|AZD1656|Tolerable dose given twice daily
16271145|NCT00856908|Drug|Placebo|Tolerable dose given twice daily
16271146|NCT00856882|Dietary Supplement|soy protein|
16271147|NCT00856882|Dietary Supplement|isoflavones|
16271148|NCT00856882|Dietary Supplement|milk protein|
16271149|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271150|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271151|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271152|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271153|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271154|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271155|NCT00856869|Drug|NRL972|Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
16271156|NCT00856856|Device|Bioabsorbable Everolimus Eluting Coronary Stent|Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
16271157|NCT00856843|Drug|BLI800|Solution for oral administration prior to colonoscopy
16271158|NCT00856843|Drug|Polyethylene glycol 3350 based bowel preparation|Solution for oral administration prior to colonoscopy
16271159|NCT00856830|Drug|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
~All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging.
~At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed-up for recurrent disease every 8 weeks."
16271160|NCT00856817|Drug|L-arginine + heme arginate|L-arginine first, heme arginate second three day treatment
16271161|NCT00856817|Drug|Heme arginate + L-arginine|Heme arginate first, L-arginine second three day treatment
16271162|NCT00856804|Drug|thalidomide|Open-label pilot study analyzing the impact of adding thalidomide (200 mg/d)to SOC on 12 weeks virological response in patients with chronic hepatitis C and interferon resistance.
16271163|NCT00856791|Drug|ON 01910.Na|
16271164|NCT00856778|Device|Virtue® Male Incontinence Sling|The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
16271165|NCT00856765|Device|Drug eluting balloon|Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
16271166|NCT00856765|Device|Bare metal stent|Bare metal stent
16271167|NCT00856765|Device|Drug eluting stent|Paclitaxel eluting stent
16271168|NCT00856752|Drug|NRL972|Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
16271169|NCT00856752|Drug|NRL972|Reference test: Single intravenous administration of 2 mg NRL972
16271170|NCT00856752|Drug|NRL972|Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
16271171|NCT00856726|Drug|1-34 parathyroid infusion|1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
16271172|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271173|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271174|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271175|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271176|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271177|NCT00856713|Drug|NRL972|Single intravenous dose of 2 mg NRL972
16271178|NCT00856700|Drug|GLP-1 infusion|Participants will receive intraarterial infusion of GLP-1 (20 pmol/ml solution) for 100 min.
16271179|NCT00856687|Drug|PF-03893787|Oral, two doses 12 hours apart
16271180|NCT00856687|Drug|Placebo|Oral, two doses 12 hours apart
16271181|NCT00856687|Drug|Montelukast|Oral, two doses 12 hours apart
16271182|NCT00856674|Biological|OPL-CCL2-LPM|"CCL2-LPM
~intravenous 0.001 mg/kg, 0.01 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.5 mg/kg, 1 mg/kg
~2 doses one week apart"
16271183|NCT00856661|Drug|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day
16271184|NCT00856661|Drug|Placebo|IV, single bolus over 1 to 2 minutes on 1st day
16271185|NCT00856648|Device|SmartPill ingestion and monitoring|The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.
16271186|NCT00856635|Drug|Glatiramer Acetate|20 mg injected daily subcutaneously
16271187|NCT00856635|Drug|placebo|injected daily subcutaneously
16271188|NCT00856622|Drug|i. Fixed combination of latanoprost 0.005% and timolol 0.5%|one drop in the morning and placebo in the evening
16271189|NCT00856622|Drug|timolol 0.5% ophthalmic solution|one drop in the morning and evening
16271190|NCT00856622|Drug|latanoprost 0.005% ophthalmic solution|placebo in the morning and latanoprost .005% in the evening
16271191|NCT00856609|Drug|Byetta (exenatide)|Exenatide is an injectable medication
16271192|NCT00856609|Behavioral|Weight loss|Because response to weight loss
16271193|NCT00856609|Other|Metabolic Chamber|The subject stays in the small room
16271194|NCT00856609|Drug|Placebo|
16271195|NCT00856596|Drug|Sertaconazole nitrate cream 2%|Once a day topical cream
16271196|NCT00856583|Drug|Sertindole|Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases
16271197|NCT00856583|Drug|Risperidone|Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day
16271198|NCT00856570|Drug|warfarin|Oral
16271199|NCT00856570|Drug|YM178|Oral
16271200|NCT00856557|Behavioral|Seminar and Practicum|A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
16271201|NCT00856544|Drug|CP-690,550|Film coated tablet, 5 mg PO BID, 1 year
16271202|NCT00856544|Drug|CP-690,550|Film coated tablet, 10 mg PO BID, 1 year
16271203|NCT00856544|Drug|Placebo|Film coated tablet, 1 tablet PO BID, 3-6 months
16271204|NCT00856544|Drug|Placebo|Film coated tablet, 1 tablet PO BID, 3-6 months
16271205|NCT00856518|Device|EMST|Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.
16271206|NCT00856518|Device|Sham|The same device just like the EMST but does not provide a load on the target muscle group
16271207|NCT00856505|Drug|Everolimus and mycophenolate sodium|Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident
16271208|NCT00856492|Biological|bevacizumab|Given IV
16271209|NCT00856492|Biological|pegfilgrastim|Given subcutaneously
16271210|NCT00856492|Drug|cyclophosphamide|Given IV
16271211|NCT00856492|Drug|doxorubicin hydrochloride|Given IV
16271212|NCT00856492|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16271213|NCT00856479|Device|Infuse Bone Morphogenic Protein (BMP) 2|"Infuse is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. Infuse may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention."
16271214|NCT00856479|Procedure|iliac crest autograft|A piece of the patients iliac crest bone is take and mixed with bone from a bone bank to supplement the bone loss in the fracture
16271215|NCT00856453|Behavioral|Home yoga practice|training for and tracking of patient's practice of yoga at home
16271216|NCT00856453|Behavioral|yoga classes|organized out of home classes for yoga
16271217|NCT00856440|Drug|Fleets Oral Sodium Phosphate Solution (OSPS)|Osmotic preparation for colonoscopy
16271218|NCT00856440|Drug|Colyte|Lavage preparation for colonoscopy
16271219|NCT00856440|Drug|Dual (OSPS & Colyte)|Combined, two-day preparation utilizing both preparations
16271220|NCT00856427|Radiation|radiation therapy treatment planning/simulation|Undergo implantation of radio-opaque markers
16271221|NCT00856427|Procedure|implanted fiducial-based imaging|Undergo implantation of radio-opaque markers
16271222|NCT00856414|Biological|botulinum toxin Type A|20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
16271223|NCT00856401|Drug|PTH1-84 in parent study|daily injection of rhPTH(1-84); 25, 50 75, or 100mcg in parent study. In ADD-ON study, there is no intervention, only testing.
16271224|NCT00856388|Drug|fludarabine phosphate|Given IV
16271225|NCT00856388|Drug|melphalan|Given IV
16271226|NCT00856388|Radiation|total-body irradiation|Undergo total-body irradiation
16271227|NCT00856388|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic stem cell transplantation
16271228|NCT00856388|Biological|anti-thymocyte globulin|Given IV
16271229|NCT00856375|Drug|NKTR-102|IV every 3 weeks
16271230|NCT00856375|Drug|irinotecan|IV every 3 weeks
16271231|NCT00856362|Drug|Moxidectin|
16271232|NCT00856362|Drug|Midazolam|
16271233|NCT00856349|Behavioral|Therapy Programming Report (TPR)|Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study.
16271234|NCT00856336|Drug|DMXAA|DMXAA, given intravenously over 20 minutes. Patients were to each undergo six doses of treatment at weekly intervals, receiving each of six doses (300, 600, 1200, 1800, 2400 and 3000 mg/m2)
16271235|NCT00856323|Drug|Truvada|At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
16271236|NCT00856323|Behavioral|CM|Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites.
16271237|NCT00856310|Biological|REGN475 (SAR164877)|Subcutaneous administration REGN475 (SAR164877)
16271238|NCT00856297|Biological|MenACWY-CRM conjugate vaccine|
16271239|NCT00856297|Biological|Licensed comparator|
16271240|NCT00856284|Drug|Alogliptin|Alogliptin tablets
16271241|NCT00856284|Drug|Metformin|Metformin tablets
16271242|NCT00856284|Drug|Glipizide|Glipizide tablets
16271243|NCT00856271|Drug|olmesartan medoxomil|oral tablets, once daily for 8 weeks
16271244|NCT00856271|Drug|losartan potassium|capsules, once daily for 8 weeks
16271245|NCT00856258|Drug|PF 03882845 and Placebo|The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.
16271329|NCT00855582|Drug|Placebo|Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.
16271246|NCT00856258|Drug|PF 03882845 and Placebo|The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
16271247|NCT00856258|Drug|PF 03882845 and Placebo|The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
16271248|NCT00856258|Drug|PF 03882845 and Placebo|The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
16271249|NCT00856245|Drug|Rituximab|375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
16271250|NCT00856232|Biological|Medical Air|Compressed medical air
16271251|NCT00856232|Biological|Oxygen|Medical Oxygen
16271252|NCT00856219|Dietary Supplement|Enteral Continuous|Continuous Tube Feeding for 72 hours
16271253|NCT00856219|Dietary Supplement|Enteral Intermittent|Intermittent Tube Feedings
16271254|NCT00856219|Dietary Supplement|Parenteral Continuous|Parenteral Continuously for 72 hours
16271255|NCT00856206|Biological|Rilonacept|Rilonacept 160 mg subcutaneous injection once a week
16271256|NCT00856206|Other|Placebo|Placebo subcutaneous injection once a week
16271257|NCT00856193|Drug|Placebo|Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
16271258|NCT00856193|Drug|NVA237|NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
16271259|NCT00856180|Drug|Bevacizumab|
16271260|NCT00856180|Drug|Cyclophosphamide|
16271261|NCT00856167|Drug|TCM|whole system Traditional Chinese Medicine, including acupuncture, herbs, tuina, lifestyle counseling
16271262|NCT00856167|Behavioral|Self-care for TMD|a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification
16271263|NCT00856154|Biological|Peptides on autologous Dendritic Cells|"10 Peptides Pulsed onto 10e7 autologous macrophage-derived maturated dendritic cells administered s.c. week 0, 2, 4, 8.
~Gag150 RLLNAWVKV
~Gag433 FLGKIWPV
~Env 67 NIWATHACV
~Pol606 KLGKAGYVV
~Vpu66 ALVEMGHHV
~Vif101 GLADQLIHL
~Vif23 SLVKHHMYV
~Gag298 KRWIILGLNKIVRMY
~gp41 VWGIKQLQARVLAVERYLKD
~Padre AKXVAAWTLKAAA"
16271264|NCT00856141|Device|phacoemulsifcation|A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
16271265|NCT00856141|Device|phacoemulsifcation|A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
16271266|NCT00856115|Other|medical chart review|Patient charts are reviewed to obtain medical data.
16271267|NCT00856115|Other|questionnaire administration|Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process. Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics. Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
16271268|NCT00856115|Other|study of socioeconomic and demographic variables|Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity).
16271269|NCT00856115|Other|survey administration|Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.
16271270|NCT00856102|Behavioral|Exercise|Home-base walking program
16271271|NCT00856102|Behavioral|Control|Usual care
16271272|NCT00856089|Drug|Retapamulin|Retapamulin ointment, 1%, apply a thin layer, BID for 5 days
16271273|NCT00856063|Drug|atomoxetine (or placebo)|Each child will be randomized to receive either ATMX or placebo in the 1st crossover phase followed by the alternative drug condition in the 2nd crossover phase. The study drug (ATMX or placebo) will be administered BID and will be titrated blindly based on clinical response and tolerability. ATMX will be initiated at 0.5 mg/kg/day for 3 days. Based on clinical response, ATMX dose will be titrated to 0.8 mg/kg/day during week 1, 1.4 mg/kg/day during week 2, and a maximum of 1.8 mg/kg/day during week 3, unless serious untoward effects intervene.
16271274|NCT00856050|Drug|letrozole|Taken orally once a day continuously
16271275|NCT00856037|Drug|Doxorubicin Hydrochloride|Given IV
16271276|NCT00856037|Other|Laboratory Biomarker Analysis|Correlative studies
16271277|NCT00856037|Other|Quality-of-Life Assessment|Ancillary studies
16271278|NCT00856037|Drug|Topotecan Hydrochloride|Given PO
16271279|NCT00856024|Biological|Peginterferon alfa-2b|PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
16271280|NCT00856024|Drug|Ribavirin|Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
16271281|NCT00855985|Procedure|type of anastomosis after pancreaticoduodenectomy|pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
16271282|NCT00855972|Drug|Low Dose Naltrexone|
16271283|NCT00855959|Drug|Budesonide|Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
16271284|NCT00855959|Drug|Pulmicort Turbuhaler|Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
16271285|NCT00855933|Device|Experimental Floss|Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
16271286|NCT00855920|Drug|Rilonacept|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
16271287|NCT00855920|Drug|Indomethacin|Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
16271288|NCT00855920|Other|Placebo (for Indomethacin)|Placebo (for Indomethacin) orally TID for 12 days.
16271289|NCT00855920|Other|Placebo (for Rilonacept)|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
16271372|NCT00855192|Behavioral|interpersonal therapy|psycho-educational
16271290|NCT00855907|Other|clinical evaluation|"Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome.
~Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography."
16271291|NCT00855894|Drug|Pertuzumab|After a single administration of a loading dose of 840 mg IV, patients received a maintenance dose of 420 mg IV every 3 weeks (q3w).
16271292|NCT00855894|Drug|Erlotinib|Patients received 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
16271293|NCT00855881|Drug|tegafur-uracil|tegafur-uracil 1 cap, bid for 1 year
16271294|NCT00855868|Drug|florbetapir F 18|370 MBq (10 mCi), intravenous (IV) injection, single dose
16271295|NCT00855868|Drug|[11C]-PIB|555 MBq (15 mCi), IV injection, single dose [11C]-PIB
16271296|NCT00855855|Biological|DTaP-IPV/Hib|0.5 mL, Intramuscular
16271297|NCT00855842|Device|osmotic dilator insertion|osmotic dilators are placed in the cervix to cause cervical dilation
16271298|NCT00855829|Device|Miniature Actilady device active|"Devices: Targeted pressure waves are created by two kind of methods ActiLady).
~The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an off the shelf pressure waves generator and controller.
~Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves."
16271299|NCT00855829|Device|Miniature Actilady device not active|"Devices: Targeted pressure waves are created by two kind of methods ActiLady).
~The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an off the shelf pressure waves generator and controller.
~Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves."
16271300|NCT00855816|Behavioral|Breathing training|relaxation training
16271301|NCT00855803|Radiation|radiation|Given in 1 or 5 fractions
16271302|NCT00855790|Other|evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep|Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.
16271303|NCT00855777|Drug|etoricoxib|etoricoxib 120 mg/day for 3 days
16271304|NCT00855777|Drug|ibuprofen|ibuprofen 1,800 mg/day for 3 days
16271305|NCT00855764|Drug|Paclitaxel|Solution, IV, 100 mg/m2, weekly for 6 of 7 weeks, until evidence of disease progression or unacceptable side effects became apparent
16271306|NCT00855738|Drug|Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide|"Gabapentin: up to 3.600 mg/d
~Lamotrigine: up to 400 mg/d
~Levetiracetam: up to 3.000 mg/d
~Pregabalin: up to 600 mg/d
~Oxcarbazepine: up to 2.400 mg/d
~Tiagabine: up to 30 mg/d
~Topiramate: up to 400 mg/d
~Zonisamide: up to 500 mg/d"
16271307|NCT00855725|Other|fMRI|Subjects will undergo MRI scanning to gather data about cognetive functions.
16271308|NCT00855725|Other|Hamilton Depression Rating Scale|Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.
16271309|NCT00855725|Other|Beck's Depressive Inventory|Subjects will complete self assessment to evaluate their level of depression.
16271310|NCT00855725|Other|Interictal Dysphoric Disorder Inventory (IDDI)|Subject will complete self assessment to determine if there have been any changes in mood, emotions and or feelings from time to time.
16271311|NCT00855712|Device|Organ Care System|The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.
16271312|NCT00855712|Device|Cold Cardioplegia Solution|This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
16271313|NCT00855699|Drug|Acamprosate|Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
16271314|NCT00855686|Drug|Memantine|20mg once daily oral dose
16271315|NCT00855686|Drug|Placebo|Daily oral dose
16271316|NCT00855673|Device|Intermittent Mechanical Compression|FM220 device
16271317|NCT00855673|Drug|Control|Standard medical treatment
16271318|NCT00855660|Drug|Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg|Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.
16271319|NCT00855660|Drug|Placebo|Placebo administered as a single tablet, thrice daily, over 14 days.
16271320|NCT00855647|Procedure|Hypo-fractionated Radiotherapy|
16271321|NCT00855634|Procedure|Resection of metastases|resection of the primary tumor, followed by resection of the liver metastasis/metastases
16271322|NCT00855634|Procedure|Resection of infiltrated veins|resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic
16271323|NCT00855621|Procedure|Deep brain stimulation of the subthalamic nucleus|Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.
16271324|NCT00855608|Drug|adalimumab|intravitreal adalimumab injection 0.03 ml in volume (1.5mg) one dose to one eye
16271325|NCT00855595|Drug|Azelaic acid (Finacea, BAY39-6251)|Participants received topical azelaic acid gel 15% twice daily for 12 weeks
16271326|NCT00855595|Drug|Metronidazole (Metrogel)|Participants received topical metronidazole 1% gel once daily for 12 weeks
16271327|NCT00855595|Drug|Doxycycline (Oracea)|Participants received systemic doxycycline 40 mg once daily for 12 week
16271328|NCT00855582|Drug|Tadalafil|tablet once daily by mouth for 12 weeks.
16271330|NCT00855569|Device|Stasilon|Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.
16271331|NCT00855556|Genetic|blood draw|"The blood collection is designed to obtain blood samples as a source of DNA for genotyping and to establish a plasma and serum storage repository for future assays. GCRC nurses will perform all blood draws associated with this study. The following procedures are designed to standardize sample collection:
~Blood will be collected with the participant in the seated position with the reclining position reserved for those with a history of fainting during blood collection.
~Participants will be instructed to drink plenty of water (e.g., at least 8 large glasses of water) prior to the clinic visit as this facilitates easier collection.
~No fasting, activity or medication restrictions are required prior to or following blood collection.
~Blood collection will follow completion of the questionnaires. They will be performed by a nurse or technician with documented class time and experience in phlebotomy. Technician certification will occur prior to blood collection."
16271332|NCT00855530|Drug|amibegron (SR58611A)|oral administration of 300 mg twice daily
16271333|NCT00855517|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
16271334|NCT00855491|Procedure|Phaco|AcrySof Single-Piece IOL
16271335|NCT00855478|Device|Cypher stent ™ or Cypher Select ™|Cypher drug-eluting stent
16271336|NCT00855465|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
16271337|NCT00855465|Drug|Placebo|Matching Placebo tid orally for 16 weeks
16271338|NCT00855452|Procedure|one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically|Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2(LAK) followed by rIL-2 inoculation in vivo
16271339|NCT00855439|Drug|Exenatide|Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels
16271340|NCT00855439|Drug|Glargine|Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control
16271341|NCT00855413|Drug|Darunavir|800 mg orally once daily
16271342|NCT00855413|Drug|Ritonavir|100 mg orally once daily
16271343|NCT00855413|Drug|Etravirine|200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen
16271344|NCT00855400|Procedure|Laminectomy and bone marrow stem cells transplantation|T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
16271345|NCT00855400|Procedure|Autologous bone marrow cells collection|Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.
16271346|NCT00855387|Other|No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel|No additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs
16271347|NCT00855361|Drug|Rabeprazole sodium|One single daily dose of rabeprazole sodium 1 mg as a microgranule formulation for up to 28 consecutive days (Part 1), and one single daily dose of rabeprazole sodium 2 or 3 mg as a microgranule formulation for up to 28 consecutive days (Part 2). The study drug will be administered through a nasogastric or orogastric tube.
16271348|NCT00855348|Other|All eligible subjects will provide blood for SEPT9 biomarker testing|A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.
16271349|NCT00855335|Drug|Darunavir|TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1. TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum in Group 2.
16271350|NCT00855335|Drug|Ritonavir|100 mg tablet twice daily up to 12 weeks postpartum.
16271351|NCT00855335|Drug|Etravirine|200 mg (1*200 mg/2*100 mg) tablets twice daily up to 12 weeks postpartum.
16271352|NCT00855335|Drug|Rilpivirine|One 25 mg tablet once daily up to 12 weeks postpartum.
16271353|NCT00855335|Drug|Darunavir/Cobicistat (FDC)|Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.
16271354|NCT00855322|Other|Gym exercise group intervention|Gym based circuit class
16271355|NCT00855322|Other|Hydrotherapy group exercise intervention|Hydrotherapy group exercise class
16271356|NCT00855322|Other|Control group|No intervention
16271357|NCT00855309|Drug|acyclovir sodium|Given IV
16271358|NCT00855283|Drug|IN NEO|20 mg Neostigmine via intranasal and sublingual administration
16271359|NCT00855283|Drug|IN NEO|40 mg Neostigmine via intranasal administration
16271360|NCT00855283|Drug|IN NEO|60 mg Neostigmine via intranasal administration
16271361|NCT00855283|Drug|IN NEO + IN Glycopyrrolate|Intranasal or sublingual Neostigmine (at effective dose: 20, 40, or 60 mg) + 4-12 mg intranasal or sublingual Glycopyyrolate
16271362|NCT00855283|Drug|IV Visit|2mg NEO and .4mg GLY given intravenously to see if the subject responds to the intervention. If they respond, then they will proceed to the IN portion of the study.
16271363|NCT00855270|Drug|Placebo|IV saline will be used as placebo for control
16271364|NCT00855270|Drug|Hydrocortisone|A single dose 90-150mg of Intra Venous Hydrocortisone. 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg.
16271365|NCT00855257|Drug|Acid Nicotinique|
16271366|NCT00855257|Drug|Placebo|
16271367|NCT00855244|Other|Diagnostic exams|Growth hormone stimulation testing, oral glucose tolerance test, hyperinsulinemic euglycemic clamp
16271368|NCT00855218|Drug|Sorafenib (Nexavar, BAY43-9006)|800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. [twice daily], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead
16271369|NCT00855218|Drug|Placebo|4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
16271370|NCT00855205|Drug|Rituximab|Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
16271371|NCT00855192|Behavioral|mindful meditation|interpersonal and psycho-educational
16271373|NCT00855179|Drug|Red vine leaf extract (AS 195)|Antistax film-coated tablet 360 mg
16271374|NCT00855179|Drug|Placebo|Placebo tablets identical to those containing Anstistax 360 mg
16271375|NCT00855166|Drug|Dapagliflozin|Tablet oral 10 mg total daily dose once daily 102 weeks
16271376|NCT00855166|Drug|Metformin|Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
16271377|NCT00855166|Drug|Sitagliptin|Tablet oral 100 mg total daily dose once daily rescue medication
16271378|NCT00855166|Drug|Placebo|Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
16271379|NCT00855153|Other|VR (Virtual reality)|VR stimulation of combat scenarios utilized as the exposure therapy tool.
16271380|NCT00855153|Drug|D-Cycloserine|50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
16271381|NCT00855140|Other|Acupuncture|Acupuncture, derived from the TCM literature, specific for insomnia
16271382|NCT00855114|Drug|everolimus|5 mg/day x 7 days by mouth
16271383|NCT00855114|Procedure|therapeutic conventional surgery|Definitive excision of breast cancer tissue
16271384|NCT00855101|Drug|voriconazole|6 mg/kg IV q12h on Day 1, and 4 mg/kg IV q12h on Days 2-7, then switch to 200 mg oral tablet q12h on Days 8-14.
16271385|NCT00855088|Drug|darunavir|Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days)
16271386|NCT00855088|Drug|Ritonavir|Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days)
16271387|NCT00855088|Drug|Etravirine|Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)
16271388|NCT00855075|Device|Cerebral State Monitor|A cerebral state monitor will provide a cerebral state index for mechanically ventilated intensive care patients. Recorded cerebral state indexes will be correlated with clinical assessments of sedation using the Richmond Agitation-Sedation Scale.
16271389|NCT00855062|Drug|minocycline|100 mg capsule every 12 hours by mouth
16271390|NCT00855062|Drug|minocycline placebo capsule|1 capsule every 12 hours by mouth
16271391|NCT00855049|Drug|Acetaminophen|Intranasal acetaminophen administration
16271392|NCT00855049|Drug|Acetaminophen|Oral acetaminophen administration
16271394|NCT00855010|Drug|pioglitazone|pioglitazone 45 mg daily
16271395|NCT00855010|Drug|placebo|one daily
16271396|NCT00854984|Behavioral|Living Life to the Full|A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
16271397|NCT00854971|Biological|TKCell|Biological/Vaccine: TKCell
16271398|NCT00854945|Drug|ON 01910.Na|1800 mg/day as a 24-hour continuous intravenous infusion administered three times a week every 2 weeks
16271399|NCT00854932|Other|Procalcitonin-guided decision making|In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.
16271400|NCT00854919|Drug|atypical antipsychotic drug|For SSRI-refractory group, either atypical antipsychotic such as mean doses of RIS (3.1±1.9mg/day), of OLZ (5.1±3.2mg/day), and of QET (60.0±37.3mg/day) was added on ongoing SSRI(Paroxetine, Fluvoxamine).
16271401|NCT00854919|Behavioral|exposure response prevention|After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.
16271402|NCT00854893|Device|transcranial direct current stimulation|1 mV for 20 min (verum conditions: anodal and cathodal)or 30 seconds (placebo condition: sham) during language learning , active electrode over primary motor cortex of language dominant hemisphere, reference electrode over contralateral supraorbital area
16271403|NCT00854880|Drug|PDC339|
16271404|NCT00854880|Drug|Placebo|
16271405|NCT00854867|Drug|Whole Brain Radio Therapy (WBRT) with sequential Depocyte|
16271406|NCT00854867|Drug|Whole brain radiotherapy (WBRT) with concomitant Depocyte|
16271407|NCT00854854|Biological|TKCell|"TKCell 150ml IV for 7times after each FOLFOX-4 regimen :
~From the second cycle of FOLFOX4(start Day1),TKCell is administered in Day3 and Day8.In the third cycle of FOLFOX4(Day1),TKCell is administered in Day3 and Day8.In the fourth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the fifth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the sixth cycle of FOLFOX4(Day1),TKCell is administered in Day8"
16271408|NCT00854841|Drug|Dasatinib and Imatinib|"Dasatinib Dasatinib will be administered orally at a dose of 100 mg QD. During the first month, subjects will be instructed to take dasatinib in the morning.
~Imatinib Imatinib will be administered orally at a dose of 600 mg once daily (QD). Each 600 mg dose should be administered with a meal and taken with a large glass of water. If a scheduled dose is missed for more than 12 hours or dosing is interrupted for toxicity or for any other reason, these doses should be omitted."
16271409|NCT00854828|Procedure|Surgical intervention|Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
16271410|NCT00854828|Other|Non-operative intervention|Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
16271411|NCT00854815|Procedure|Irrigation|Irrigation of the area with at least 500ml NS using the power suction/irrigator
16271412|NCT00854815|Procedure|No Irrigation|Suction only using suction/irrigator
16271413|NCT00854802|Drug|Debio 025|Debio 025 supplied in soft gel capsules
16271414|NCT00854802|Drug|Peg-IFNα2a|Peg-IFNα2a supplied in pre-filled syringes
16271415|NCT00854802|Drug|Ribavirin|Ribavirin supplied in tablets
16271416|NCT00854802|Drug|Debio 025 placebo|Debio 025 placebo supplied in soft gel capsules
16271417|NCT00854789|Biological|E75 + GM-CSF vaccine|The 1 ml by volume vaccine is administered intradermally in 0.5 ml inoculums at two different sites within 5 cm of each other on an extremity. Vaccinations will be given according to the schedule the patient has been assigned and will be administered in the same lymph node draining area (same arm or thigh). In addition, an optional booster inoculation as requested by previously vaccinated patients will be offered every 6 months for the duration of the protocol. The dose will be determined by the PI based on the patient's response to the initial vaccination series.
16271418|NCT00854776|Drug|lansoprazole|30 mg once daily
16271763|NCT00852202|Drug|cariprazine|Drug: cariprazine (1.5 - 3.0 mg/day)
16271419|NCT00854776|Drug|aluminum hydroxide 334 mg and Mg hydroxide 166 mg|1 tablet once daily
16271420|NCT00854763|Drug|olmesartan|olmesartan
16271421|NCT00854750|Drug|ACTHAR|SQ weekly injections
16271422|NCT00854750|Drug|ACTHAR|SQ weekly injections
16271423|NCT00854750|Drug|ACTHAR|SQ weekly injections
16271424|NCT00854750|Drug|ACTHAR|SQ weekly injection
16271425|NCT00854737|Dietary Supplement|cytidine|cytidine (2g po daily for 4 months)
16271426|NCT00854737|Dietary Supplement|omega-3 fatty acids|omega-3 fatty acids (4g po daily for 4 months)
16271427|NCT00854737|Drug|placebo|sugar pill
16271428|NCT00854724|Drug|Puerarin, Placebo|400 mg, three times a day for 7 days
16271429|NCT00854711|Procedure|inhaled nitric oxide|80 PPM
16271430|NCT00854698|Other|exercise training|subjects are asked to exercise 20 or 30 minutes.
16271431|NCT00854698|Other|subjects are asked to exercise during 20 or 30 minutes|subjects are asked to exercise during 20 or 30 minutes
16271432|NCT00854685|Drug|ART621|3.0mg/kg s.c. - weekly
16271433|NCT00854685|Drug|ART621|3.0mg/kg s.c. - fortnightly
16271434|NCT00854685|Drug|ART621|1.5mg/kg s.c. - weekly
16271435|NCT00854685|Drug|ART621|1.5mg/kg s.c. - fortnightly
16271436|NCT00854685|Drug|Placebo|Placebo s.c. - weekly
16271437|NCT00854685|Drug|Placebo|Placebo s.c. - fortnightly
16271438|NCT00854659|Drug|ABT-102|BID tablets, 7 days of treatment
16271439|NCT00854659|Drug|Placebo|BID tablets, 7 days of treatment
16271440|NCT00854646|Drug|ON 01910.Na|The drug is a sterile, concentrated 75mg/mL solution in polyethylene glycol 400, in labeled, sealed glass vials. The Concentrate must be diluted with aqueous infusion solutions (0.9% NaCl, USP and Water for Injection, USP according to instructions) immediately prior to intravenous administration.
16271441|NCT00854633|Drug|Talactoferrin|Enteral, 150 mg/kg twice per day
16271442|NCT00854633|Drug|Placebo|Oral, twice per day
16271443|NCT00854620|Drug|Sorafenib|Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
16271444|NCT00854607|Other|No Intervention|Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.
16271445|NCT00854594|Behavioral|Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)|The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans.
16271446|NCT00854581|Biological|PEG-interferon alfa-2b|Administered subcutaneously.
16271447|NCT00854581|Biological|Interferon alfa-2b|Administered intravenously.
16271448|NCT00854581|Drug|Valproic Acid|Administered orally.
16271449|NCT00854581|Drug|Zidovudine|Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B).
16271450|NCT00854568|Drug|CEOP regimen|cyclophosphamide 750mg/m2 IV day 1 epirubicin 70mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1~5 twice per day Or combined with rituximab 375mg/m2 IV day 0
16271451|NCT00854568|Drug|CHOP regimen|cyclophosphamide 750mg/m2 IV day 1 doxorubicin 50mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1~5 twice per day Or combined with rituximab 375mg/m2 IV day 0
16271452|NCT00854555|Other|Locomotor training with robot|60 days locomotor training during 6 months period in out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
16271453|NCT00854555|Other|Locomotor training with manual assistance|60 days training during 6 months period on in-patient setting. Training 2 times per day total 120 minutes. Control group receives conventional training/treatment.
16271454|NCT00854542|Behavioral|Telepsychiatry-based Culturally Sensitive Collaborative Treatment|T-CSCT: Patients in Group A will receive T-CSCT, which consists of Telepsychiatry-based Culturally Sensitive Psychiatry Assessment using the Engagement Interview Protocol (EIP) plus Care Management.
16271455|NCT00854529|Drug|Bevacizumab|sub-conjunctival injection of 1.25mg Bevacizumab
16271456|NCT00854516|Procedure|A new treatment approach is to have an effective working pressure combined with a low resting pressure.|"Procedure Schedule: The total duration for study participation will be 14 days (8 visits).
~Subject eligibility will be determined at the initiation visit. All eligible subjects will receive the compression device on the study leg and will return to the clinical center at day 1, 2, 3, 4, 7, 10 and 14 to assess safety. At each clinical visit (except visit day 14) the compression device will be reapplied. The study participation ends after 14 days."
16271457|NCT00854503|Drug|Simvastatin|20 mg/day in one oral administration
16271458|NCT00854503|Drug|Rosuvastatin|20 mg/day in one oral administration.
16271459|NCT00854477|Drug|capecitabine|film-coated tablet 1250 mg/m2 twice daily for 14 days every 3 weeks. Number of cycles: 8 cycles unless there is evidence of disease progression, or unacceptable toxicity
16271460|NCT00854451|Drug|omeprazole plus amoxicillin|
16271461|NCT00854451|Drug|omeprazole plus amoxicillin|
16271462|NCT00854451|Drug|omeprazole plus amoxicillin|
16271463|NCT00854451|Drug|omeprazole plus amoxicillin|
16271464|NCT00854438|Other|Multidisciplinary drug reviews by pharmacist and physician|Reduction of anticholinergic drug effects by pharmacist review
16271465|NCT00854425|Drug|L-asparaginase|L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
16271466|NCT00854412|Other|Weight loss|Very low-calorie diet (VLCD) of 800 kcal/day for 8 weeks
16271467|NCT00854399|Procedure|Staging surgery or debulking surgery|Staging surgery or debulking surgery
16271468|NCT00854386|Drug|liberal fluid administration|patients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution
16271469|NCT00854386|Drug|restrictive fluid administration|Patients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period
16271470|NCT00854373|Drug|Bravelle(follicle stimulating hormone)|One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
16271471|NCT00854373|Other|Saline ( placebo)|1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
16271472|NCT00854360|Drug|Beclomethasone dipropionate HFA Nasal Aerosol|Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
16271473|NCT00854360|Drug|Placebo|HFA Vehicle Aerosol
16271474|NCT00854321|Drug|rituximab|rituximab two 1000 mg intravenous infusions separated by two weeks
16271475|NCT00854321|Drug|rituximab, observational study amon patients with active RA|two 1000 mg intravenous infusions separated by 2 weeks
16271476|NCT00854308|Drug|Erlotinib HCl|Erlotinib 150 mg oral dose once daily.
16271477|NCT00854308|Drug|MetMAb|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
16271478|NCT00854308|Drug|placebo (0.9 % saline)|Placebo Intravenous infusion every 3 weeks.
16271479|NCT00854295|Device|NexGen LPS-Flex Mobile Bearing Knee|Total Knee Replacement
16271480|NCT00854282|Procedure|Staging surgery or debulking surgery|Staging surgery or debulking surgery
16271481|NCT00854269|Procedure|surgery|cervical biopsy or specimen of hysterectomy
16271482|NCT00854256|Procedure|Canaloplasty|Canaloplasty surgery
16271483|NCT00854256|Procedure|Trabeculectomy with mitomycin C|Trabeculectomy with mitomycin C surgery
16271484|NCT00854230|Drug|Naltrexone|Naltrexone dose 25-100mg
16271485|NCT00854217|Procedure|acute normovolemic hemodilution|
16271486|NCT00854204|Drug|TMC114; TMC41629|
16271487|NCT00854191|Device|simulator training|4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training
16271488|NCT00854178|Drug|Comparison of two anesthetic drugs|Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml
16271489|NCT00854152|Drug|GDC-0980|Escalating repeating dose
16271490|NCT00854139|Drug|Cyclophosphamide, anti-thymocyte globulin|"Cyclophosphamide 60 mg/kg IV on Day -5, -4 Anti-thymocyte globulin 20 mg/kg IV on Day -1, Day +1, +3, +5
~Cyclosporine starting on Day -1 at 5 mg/kg daily I.V. and reduced to 3 mg/kg on Day +4, and adjusted to provide a trough whole blood concentration of 250-400 ng/mL. The route of administration will be changed to oral as soon as the patient is able to tolerate oral medications"
16271491|NCT00854139|Procedure|Kidney transplant|On Day 0 the renal transplant is performed according to standard surgical techniques, preferably using an iliac fossa, extraperitoneal approach
16271492|NCT00854139|Radiation|Thymic irradiation|Thymic irradiation 7 Gy on Day -1
16271493|NCT00854139|Procedure|Bone marrow transplant from a related donor|• Donor bone marrow (> 2 x 108 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure at the medical center. A total of 15,000 Units of heparin is mixed with the marrow, which is infused at a rate of 300-500 cc/hr. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Protamine, 25 mg, is administered I.V. after completion of the first half of the bone marrow infusion. If a partial thromboplastin time measured after completion of the marrow infusion is > 60 seconds, the protamine treatment shall be repeated
16271494|NCT00854126|Drug|GDC-0980|Escalating repeating dose
16271495|NCT00854113|Drug|EGT0001474|Oral ascending doses given daily as capsules for up to 14 days
16271496|NCT00854113|Drug|Placebo|Placebo to match EGT0001474
16271497|NCT00854100|Drug|Antidepressant + placebo|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
16271498|NCT00854100|Drug|Antidepressant + cariprazine (0.1-0.3 mg/day)|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
16271499|NCT00854100|Drug|Antidepressant + cariprazine (1-2 mg/d)|Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
16271500|NCT00854087|Drug|Fuzheng Huayu|The subjects will be taking 2 tablets three times a day for 48 weeks.
16271501|NCT00854087|Drug|Placebo|The subjects will be taking 2 tablets three times a day for 48 weeks.
16271502|NCT00854074|Device|ElectroCore RMS-1100 Resolution Motility System™|An electrical neurostimulation signal will be applied to the spine
16271503|NCT00854061|Drug|T-Pred|sterile ophthalmic solution
16271504|NCT00854061|Drug|Pred Forte|sterile ophthalmic solution
16271505|NCT00854035|Drug|MK-0431/ONO-5435|Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD
16271506|NCT00854035|Drug|MK-0431/ONO-5435|Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
16271507|NCT00854009|Drug|BLI-489|
16271508|NCT00854009|Drug|Placebo|
16271509|NCT00853996|Drug|acolbifene hydrochloride|Given orally
16271510|NCT00853983|Drug|[14C] AZD0530|Solution, Oral, once
16271511|NCT00853970|Drug|Bromfenac Ophthalmic Solution|sterile ophthalmic solution
16271512|NCT00853970|Drug|Placebo Comparator|sterile ophthalmic solution
16271513|NCT00853957|Drug|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
16271514|NCT00853957|Drug|Amlodipine|Amlodipine 5 mg titrated to 10mg
16271515|NCT00853944|Drug|sitagliptin|Subjects receive sitagliptin 100 mg po daily from the day of islet transplant until completion of the study
16271516|NCT00853931|Drug|Panitumumab|Panitumumab 6 mg/kg will be administered by intravenous infusion every 2 weeks (Q2W), +/- 3 days, (eg, week 1, 3, 5 [i.e. Cycles 1, 2, 3, etc.]) until disease progression or intolerance panitumumab as determined by the investigator.
16271517|NCT00853918|Other|$20 cash|$20 cash incentive mailed with survey
16271518|NCT00853918|Other|$50 cash|$50 cash incentive mailed with survey
16271519|NCT00853918|Other|$50 check|$50 check incentive mailed with survey
16271520|NCT00853918|Other|$100 check|$100 check incentive mailed with survey
16271521|NCT00853905|Drug|Triesence|At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
16272099|NCT00849602|Drug|Placebo|Placebo bid for three days
16271522|NCT00853905|Drug|balanced salt solution BSS|At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
16271523|NCT00853892|Drug|Controlled-Release Oxycodone Hydrochloride 40 mg tablet|Controlled-Release Oxycodone Hydrochloride 40 mg, single dose fasting
16271524|NCT00853892|Drug|OxyContin® 40 mg tablet|OxyContin® 40 mg tablet, single dose fasting
16271525|NCT00853879|Dietary Supplement|Folic Acid, Vitamin B6, Vitamin B12|"Intervention #1. A combination of the following vitamin supplements: 2.5mg of folate, 25mg of vitamin B6 and 2mg of vitamin B12. This combination will be described as triple therapy with folate."
16271526|NCT00853879|Dietary Supplement|B6, B12, L-methylfolate|Intervention #2. A combination of the following vitamin supplements: 2.8mg of L-methylfolate, 25 mg of vitamin B6 and 2mg of vitamin B12.
16271527|NCT00853879|Dietary Supplement|B6, B12, Placebo|"Intervention #3. A combination of the following vitamin supplements: 25mg of vitamin B6 and 2mg of vitamin B12 without supplementary folate or L-methylfolate. This combination will be described as triple therapy with placebo"
16271528|NCT00853866|Drug|reboxetine|single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
16271529|NCT00853866|Drug|Placebo|placebo, 80 min before assessment of Jebsen Taylor test
16271530|NCT00853866|Device|tDCS verum|20 minutes of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
16271531|NCT00853866|Device|tDCS sham|30 seconds of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
16271532|NCT00853853|Device|EnSeal Device|Hemorrhoidectomy using the EnSeal Device, which is an instrument cuts and seals with heat energy leaving a sutureless wound, which heals with security against bleeding.
16271533|NCT00853853|Procedure|Ferguson Hemorrhoidectomy technique|The closed Ferguson hemorrhoidectomy technique is a gold standard operation that has been in existence for 50 years. This operation is done under general or intravenous sedation, and the operating surgeon uses a special clamp to go across the hemorrhoidal complex followed by excision of the hemorrhoid. Sutures that dissolve (such as 3.0 vicryl) are then placed at the root of the hemorrhoid, securely tied, and then run about the clamp. The clamp is removed and then the suture tightened, then the suture line is reinforced. This can be done from 1-3 hemorrhoidal groups at a single time.
16271534|NCT00853840|Drug|Maraviroc|Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
16271535|NCT00853840|Drug|Vardenafil|Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
16271536|NCT00853840|Drug|Maraviroc|Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
16271537|NCT00853840|Drug|Placebo|Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
16271538|NCT00853827|Drug|Placebo|Placebo
16271539|NCT00853827|Drug|Aliskiren|300 mg
16271540|NCT00853814|Behavioral|Access to sedentary behaviors|Access to sedentary behaviors: Reduced access - reduce access to sedentary behaviors by 50% using TV Allowance technology. Usual access - monitoring only, no change in access to sedentary behaviors. Access to neighborhood parks: High access - large amount of park land very near to the child's home. Low access - little to no park land near the child's home.
16271541|NCT00853801|Behavioral|Lifestyle intervention and provider feedback|"Patients receive lifestyle education and counseling after each visit with their primary care provider. Lifestyle modification goals are set and progress monitored. Frequency is dependent on frequency of visits with primary care provider which can range from one month to nine months.
~Primary care providers of the intervention patients receive one education session at the commencement of the study covering the diagnosis and treatment of metabolic syndrome and pre-diabetes. Feedback on provider performance as assessed by provider documentation of diagnosis and treatment recommendations compared to patient outcomes is given every six months."
16271542|NCT00853775|Other|No intervention, observational study|
16271543|NCT00853762|Drug|Atacicept 25 mg|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study will continue with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
16271544|NCT00853762|Drug|Atacicept 75 mg|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study will continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
16271545|NCT00853762|Drug|Atacicept 150 mg|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study will continue with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
16271546|NCT00853762|Drug|Atacicept 150 mg|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study will continue with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
16271547|NCT00853749|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL intramuscular injection
16271548|NCT00853749|Procedure|Blood draw|Collection of 10 mL of blood
16271549|NCT00853736|Drug|Roxicodone™ tablet 30 mg|Roxicodone™ tablet 30 mg, single dose with food
16271550|NCT00853736|Drug|Oxycodone hydrochloride tablet 30 mg|Oxycodone hydrochloride tablet 30 mg, single dose with food
16271551|NCT00853723|Drug|Parathyroid hormone related protein (1-36)|PTHrP (1-36) 400 micrograms / day administered subcutaneously for 3 months
16271552|NCT00853723|Drug|Parathyroid hormone related protein(1-36)|PTHrP(1-36)600 micrograms subcutaneously administered daily for 3 months
16271553|NCT00853723|Drug|Parathyroid hormone (1-34)|PTH(1-34)20 micrograms subcutaneously administered daily for 3 months
16271554|NCT00853710|Other|PSA assay|rapid prostate specific antigen assay.
16271595|NCT00853372|Drug|Trebananib|Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.
16271555|NCT00853697|Other|testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride|"Patients will be treated with dutasteride 3.5 mg once daily (oral administration). To avoid rapid conversion of testosterone to DHT in case 5α-reductase is not adequately inhibited during the first few days of concurrent treatment with dutasteride and testosterone, daily dutasteride treatment will be initiated 7 days prior to testosterone initiation.
~Patients will receive AndroGel® at the dose of 15 g (3 times the standard replacement dose for hypogonadism) once daily (topical administration), starting on Day 8 and continuing for 12 weeks (or until disease progression or withdrawal from the study)."
16271556|NCT00853684|Drug|OXCE|Oxaliplatin 130 mg/m2 iv drip D1, Capecitabine 1000 mg/m2 bid d1-14. Every three weeks.
16271557|NCT00853684|Drug|Endostar|Endostar 7.5 mg/m2 iv drip D1-14. Every 3 weeks.
16271558|NCT00853671|Other|Adenosine Stress Dual-source CTP|"Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
~This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure."
16271559|NCT00853658|Drug|Enalapril|Enalapril 10 mg film-coated tablet and administered orally.
16271560|NCT00853658|Drug|Aliskiren|Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.
16271561|NCT00853645|Device|Subcutaneous Implantable Defibrillator (S-ICD) System|
16271562|NCT00853632|Device|CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES|Mitral valve replacement
16271563|NCT00853619|Other|Service based decision support intervention|Delivering CDS via services
16271564|NCT00853606|Drug|avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
16271565|NCT00853593|Device|Pacing Lead|implant and follow-up of study device
16271566|NCT00853580|Drug|Lovastatin ™|Lovastatin starting at 20mg for 2 weeks, increasing to 40mg for 14 weeks. Total duration of trial is 16 weeks.
16271567|NCT00853580|Device|placebo|Starting at 20mg for 2 weeks, then increasing to 40mg for 14 additional weeks for a total duration of treatment of 16 weeks.
16271568|NCT00853567|Drug|Proellex|25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
16271569|NCT00853567|Other|placebo|Placebo
16271570|NCT00853554|Drug|Hydromorphone Hydrochloride tablet 8 mg|Hydromorphone Hydrochloride tablet 8 mg, single dose fasting
16271571|NCT00853554|Drug|Dilaudid® tablet 8 mg|Dilaudid® tablet 8 mg, single dose fasting
16271572|NCT00853528|Other|questionnaire administration|prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
16271573|NCT00853528|Procedure|diffusion tensor imaging|prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
16271574|NCT00853528|Procedure|functional magnetic resonance imaging|prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
16271575|NCT00853528|Radiation|hypo-fractionated SRS|two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
16271576|NCT00853528|Radiation|single-fraction SRS|two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy
16271577|NCT00853515|Other|Goal-directed fluid resuscitation|Targeted, weight-based fluid resuscitation
16271579|NCT00853489|Device|recombinant bone morphogenetic protein 2|Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft
16271580|NCT00853489|Procedure|Autogenous iliac crest bone graft|Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.
16271581|NCT00853463|Behavioral|Alert|The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders
16271582|NCT00853450|Drug|AZD6482|Single intravenous infusion during a maximum of 5 hours
16271583|NCT00853450|Drug|Clopidogrel|Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
16271584|NCT00853450|Drug|ASA|75 mg orally once daily during 7 days in each treatment arm
16271585|NCT00853424|Procedure|islet cell transplant|Human pancreases are retrieved from multiorgan donors and processed with intraductal collagenase perfusion, continuous digestion, and density gradient purification with impure tissue fractions cultured in vitro and then repurified to retrieve additional islets. Islets are implanted by ultrasound guided percutaneous portal embolization, to provide more than 12, 000 islet equivalents (IE) per kilogram of body weight (infusions from 1-3 donors per patient) Immunosuppression consists of antithymocyte globulin, basiliximab, mycophenolate mofetil and tacrolimus as described (Warnock et al Arch Surg 2005;140:735).
16271586|NCT00853424|Other|Medical therapy|subjects receive all recommended medical treatment for diabetes and diabetic eye disease
16271587|NCT00853411|Drug|prednisone|Druing asthma exacerbation, subjects will be dosed to prednisone.
16271588|NCT00853398|Procedure|surgical technique|
16271589|NCT00853385|Drug|CP 690,550|tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
16271590|NCT00853385|Drug|CP-690,550|tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
16271591|NCT00853385|Other|Placebo|placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
16271592|NCT00853385|Other|Placebo|tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
16271593|NCT00853385|Biological|Biologic TNFi|placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
16271594|NCT00853372|Drug|Sunitinib|Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants.
16272100|NCT00849602|Drug|Chloroquine|Chloroquine bid for three days
16271596|NCT00853346|Behavioral|Cognitive Behavioral Therapy|12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
16271597|NCT00853346|Behavioral|Cognitive Behavioral Therapy|12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
16271598|NCT00853333|Drug|dexmedetomidine|
16271599|NCT00853333|Drug|midazolam|
16271600|NCT00853333|Drug|propofol|
16271601|NCT00853320|Drug|Oxycodone hydrochloride tablet 15 mg|Oxycodone hydrochloride tablet 15 mg, single dose fasting
16271602|NCT00853320|Drug|Roxicodone™ tablet 15 mg|Roxicodone™ tablet 15 mg, single dose fasting
16271603|NCT00853307|Drug|Alisertib|Alisertib capsules
16271604|NCT00853294|Drug|Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule|Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule, single dose fasting
16271605|NCT00853294|Drug|5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension|Tussionex® Pennkinetic® Extended Release Oral Suspension, single dose fasting
16271606|NCT00853281|Other|Hammocks with LLIN|Locally-made hammocks covered with long lasting insecticidal nel (LLIN)
16271607|NCT00853281|Other|Standard vector control measures|Insectice-treated net
16271608|NCT00853268|Drug|Controlled-Release Oxycodone Hydrochloride 40 mg|Controlled-Release Oxycodone Hydrochloride 40 mg, single dose with food
16271609|NCT00853268|Drug|OxyContin® 40 mg tablet|OxyContin® 40 mg tablet, single dose with food
16271610|NCT00853255|Biological|Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)|Vaccine administered by nasal spray
16271611|NCT00853242|Drug|Placebo|
16271612|NCT00853242|Drug|Genz-644470|
16271613|NCT00853242|Drug|Sevelamer carbonate|
16271614|NCT00853229|Drug|pregabalin|pregabalin 150mg twice daily for 4 weeks
16271615|NCT00853216|Drug|Oxycodone hydrochloride tablet 30 mg|Oxycodone hydrochloride tablet 30 mg, single dose fasting
16271616|NCT00853216|Drug|Roxicodone™ tablet 30 mg|Roxicodone™ tablet 30 mg, single dose fasting
16271617|NCT00853203|Behavioral|Interviews|Open-ended Interviews, audiotaped, lasting 30 minutes to 1 hour.
16271618|NCT00853203|Behavioral|Questionnaires|Written survey taking about 1 hour.
16271619|NCT00853203|Other|Electronically Activated Recorder (EAR)|Recording system (a digital tape-recorder and small external microphone) programmed to record for 30 seconds every 12 minutes, repeating over two consecutive days of wearing.
16271620|NCT00853203|Behavioral|Group Meetings|12 Audiotaped Group Meetings over 4 months: 9 weekly meetings, 2 semi-monthly (twice a month) meetings, and a final meeting in month 4. Each meeting will last 1 hour.
16271621|NCT00853203|Behavioral|Written Materials|Written educational materials plus community resource information.
16271622|NCT00853190|Drug|Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule|Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule, single dose with food
16271623|NCT00853190|Drug|5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension|Tussionex® Pennkinetic® Extended Release Oral Suspension, single dose with food
16271624|NCT00853177|Procedure|MEOPA inhalation|N2O of 50% and 50% O2
16271625|NCT00853177|Procedure|xylocaine|Ampoule-bottle of 20 ml
16271626|NCT00853164|Behavioral|walking exercise|Subjects will be given an exercise prescription for walking 3 times a week for eight weeks
16271627|NCT00853164|Behavioral|weight training|participants will be given a weight training prescription to do 3 times a week for eight weeks.
16271628|NCT00853164|Behavioral|Usual Care|Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.
16271629|NCT00853151|Drug|LY2428757|14 mg subcutaneous injection 1 time a week for 5 weeks
16271630|NCT00853151|Drug|TT223|subcutaneous injection once a day for 4 weeks
16271631|NCT00853151|Drug|Placebo for LY2428757|subcutaneous injection 1 time a week for 5 weeks
16271632|NCT00853151|Drug|Placebo for TT223|subcutaneous injection once a day for 4 weeks
16271633|NCT00853138|Behavioral|cognitive-behavioral therapy|"In addition to standard medical care, the children and parents in the family CBT condition will also receive education about chronic pain, pain behaviors and operant strategies as well as training in coping skills using an interactive, engaging format on the Internet.
~The Internet site will consist of three main sections: child treatment modules, parent treatment modules, and diary tracking. All users will complete 8 treatment modules (one per week) over the 8-week treatment period. Each module will require approximately 30-40 minutes to complete. There is separate specific content of the intervention for child users and for parent users.
~Assignments are incorporated into each module for the participant to work on during the treatment week."
16271634|NCT00853125|Biological|therapeutic allogeneic lymphocytes|Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response
16271635|NCT00853125|Drug|sunitinib malate|Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.
16271636|NCT00853112|Drug|PF-00489791|tablet form, 1 mg, single dose (Day 1)
16271637|NCT00853112|Drug|PF-00489791|tablet form, 2 mg, single dose (Day 1)
16271638|NCT00853112|Drug|PF-00489791|tablet form, 4 mg, single dose (Day 1)
16271639|NCT00853112|Drug|PF-00489791|tablet form, 10 mg, single dose (Day 1)
16271640|NCT00853112|Drug|PF-00489791|tablet form, 20 mg, single dose (Day 1)
16271641|NCT00853112|Drug|placebo|tablet form, single dose (Day 1)
16271642|NCT00853112|Drug|sildenafil|tablet form, 20 mg, single dose (Day 1)
16271643|NCT00853099|Biological|adalimumab|
16271644|NCT00853099|Drug|placebo|
16271645|NCT00853086|Drug|activated recombinant human factor VII|Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice
16271646|NCT00853073|Drug|bevacizumab|1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
16271647|NCT00853073|Other|balanced salt solution|0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure
16271648|NCT00853047|Drug|Telotristat etiprate|Telotristat etiprate capsules; orally 3 times daily.
16271649|NCT00853047|Drug|Octreotide LAR Depot|A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
16271650|NCT00853047|Drug|Placebo|Placebo-matching telotristat etiprate capsules; orally 3 times daily.
16271651|NCT00853034|Dietary Supplement|FOS-IN|"prebiotic fructo-oligosaccharide enriched inulin
~intake period: 2 weeks, 1.25 or 2.50g every morning and evening"
16271652|NCT00853034|Dietary Supplement|AXOS|"arabinoxylan-oligosaccharides (AXOS)
~intake period: 2 weeks, 1.25 or 2.50g every morning and evening"
16271653|NCT00853021|Biological|aldesleukin|SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
16271654|NCT00853021|Biological|bevacizumab|Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
16271655|NCT00853008|Drug|Vincristine|Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
16271656|NCT00853008|Drug|Daunorubicin|Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
16271657|NCT00853008|Drug|Prednisone|Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
16271658|NCT00853008|Drug|Mitoxantrone|Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
16271659|NCT00853008|Drug|Cytosine Arabinoside|ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
16271660|NCT00853008|Drug|Dexamethasone|Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
16271661|NCT00853008|Drug|Methotrexate (MTX)|Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
16271662|NCT00853008|Drug|Cytarabine|Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
16271663|NCT00853008|Drug|ASP|ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
16271664|NCT00853008|Drug|Mercaptopurine|Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
16271665|NCT00853008|Drug|Teniposide|Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
16271666|NCT00853008|Drug|Hydrocortisone|Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
16271667|NCT00852995|Biological|HP802-247|One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
16271668|NCT00852995|Biological|Placebo (Vehicle)|"Placebo (Vehicle) consisting of:
~Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution"
16271669|NCT00852982|Behavioral|Exercise|Nordic walking, with walking poles, five hours per week during four months
16271670|NCT00852969|Drug|Niacin|1000 mg tablets once per day
16271671|NCT00852969|Drug|Active Placebo|100 mg Niacin tablets once per day
16271672|NCT00852956|Drug|Betahistine|"The study will be comprised of three treatment periods for a total of 4 weeks treatment duration:
~Period I 1 week (Days 1-7) administration of betahistine 48 mg three times daily (144 mg/day total) or matching placebo Period II 1 week (Days 8-14) titration of olanzapine once daily (from 2.5 mg up to 10 mg) and continuation of betahistine or matching placebo administration (three times daily as in Period I) Period III 2 weeks (Days 15-28) of co-administration of betahistine or matching placebo (three times daily; as in Periods II and III) and olanzapine once daily (7.5 or 10 mg, as tolerated)
~On Day 1, after a 7-day screening period, eligible subjects will be randomized to one of the two treatment groups in a 1:1 ratio:
~Betahistine 48 mg TID; 08:00, 13:00 and 18:00 (144 mg/day total) Matching placebo TID; 08:00, 13:00 and 18:00"
16271673|NCT00852930|Procedure|laser and MLD combined|The intervention is therapist administered laser and mld treatment combined
16271674|NCT00852930|Procedure|laser alone|The intervention is therapist administered laser
16271675|NCT00852930|Procedure|manual lymphatic drainage|The intervention is therapist administered manual lymphatic drainage
16271676|NCT00852917|Drug|Tramadol Once A Day|One Tramadol Once A Day tablet at randomized dose daily.
16271677|NCT00852917|Drug|Placebo|One Placebo tablet daily.
16271678|NCT00852878|Behavioral|Biofeedback|Biofeedback will teach resonant frequency breathing for 6-8 sessions
16271679|NCT00852878|Behavioral|Behavioral Protocol|Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions
16271680|NCT00852865|Drug|Lactobacillus farciminis|1 capsule per day. Each capsule containing 4*109 CFU
16271681|NCT00852865|Drug|Placebo|1 capsule per day
16271682|NCT00852852|Behavioral|Electronic Self-Report Assessment - Cancer (ESRA-C)|The Electronic Self-Report Assessment-Cancer (ESRA-C) is a program allowing patients to report symptoms and quality of life issues and learn information about how to deal with these experiences.
16271683|NCT00852839|Drug|Placebo|Placebo to match oromucosal formulation of 552-02
16271684|NCT00852839|Drug|552-02|The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives.
16271685|NCT00852826|Procedure|Standard axillary lymphadenectomy|Standard axillary lymphadenectomy
16271686|NCT00852826|Procedure|Collagen sponge coated with human coagulation factors|Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls
16271687|NCT00852813|Dietary Supplement|arabinoxylan-oligosaccharides (AXOS)|intake period: 3 weeks, 10 g/day
16271688|NCT00852800|Drug|Albumin|1.5 g/kg IV on day 1 and 1 g/kg IV on day 3 with saline solution to complete total volume of 1000 ml on day 1 and 500 ml on day 3. Infusion in 4 hours.
16271689|NCT00852800|Drug|Albumin|1 g/kg IV on day 1 and 0.5 g/kg IV on day 3 with saline solution to complete total volume of 1000 ml on day 1 and 500 ml on day 3. Infusion in 4 hours.
16271690|NCT00852787|Drug|Digoxin immune fab|Intravenously one time
16271691|NCT00852787|Drug|Placebo|Intravenously one time
16271692|NCT00852761|Drug|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.
16271693|NCT00852761|Drug|Clobex lotion|Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15
16271694|NCT00852735|Dietary Supplement|Rapeseed Oil (prevention of cardiovascular diseases)|to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases
16271695|NCT00852722|Other|Low fat study diet|The low fat study diet is a very low-saturated-fat, plant food based diet. It will be approximately 10% fat, 14% protein and 76% carbohydrate.The diet is is starched based and also contains fresh or frozen fruits and vegetables and there is no animal meat used, including no use of fish. This diet is very low in saturated fats and enriched in unsaturated fats. Subjects do not take dietary supplements.
16271696|NCT00852709|Drug|Clofarabine|On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide
16271697|NCT00852709|Drug|Cyclophosphamide|Single-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide
16271698|NCT00852696|Drug|Solifenacin|Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.
16271699|NCT00852696|Other|Placebo|Take orally once daily for 9 weeks.
16271700|NCT00852683|Drug|Pregabalin|75 mg twice a day
16271701|NCT00852683|Drug|Placebo|75 mg twice a day
16271702|NCT00852670|Drug|ACT-128800|ACT-128800 administered orally once daily
16271703|NCT00852670|Drug|Placebo|Matching placebo capsules administered orally once daily
16271704|NCT00852657|Procedure|Tendon repair with acromioplasty|Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
16271705|NCT00852657|Procedure|Physiotherapy|According to a rehabilitation program which was established prior to study start.
16271706|NCT00852644|Procedure|computed tomography|Standard CT scans
16271707|NCT00852644|Radiation|fludeoxyglucose F 18|standard doses with CT scans
16271708|NCT00852644|Radiation|hypofractionated radiation therapy|4 doses over 2 weeks
16271709|NCT00852644|Radiation|stereotactic radiosurgery|CyberKnife radiosurgery
16271710|NCT00852631|Drug|Quetiapine fumarate (Seroquel)|600mg Extended release tablet, oral, once daily
16271711|NCT00852605|Other|Intermittent Non-Invasive Ventilation|
16271712|NCT00852592|Device|7000lux broad-spectrum light|dosage - 15-60minutes NOON-2PM daily
16271713|NCT00852592|Device|50lux dim red light|dosage: 15-60minutes NOON-2PM daily
16271714|NCT00852579|Drug|Azithromycin|Daily dose 250mg
16271715|NCT00852579|Drug|Placebo|Placebo
16271716|NCT00852566|Drug|Imatinib|Per oral imatinib 400mg once daily (continuous medication)
16271717|NCT00852566|Drug|Dasatinib|Per oral dasatinib 100mg once daily (continuous medication)
16271718|NCT00852540|Drug|Retpamulin Ointment, 1%|Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.
16271719|NCT00852540|Drug|Linezolid|Adult and adolescent (=>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects <5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.
16271720|NCT00852514|Device|Bioelectrical impedance-guide dry weight reduction|for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration
16271721|NCT00852501|Other|To perform RT-PCR on the tissue obtained during surgery|The performance of surgery is the standard of care in the management of non-functioning pituitary macroadenomas. The tissue obtained during surgery is routinely sent for histopathological examination. A piece of the tissue will undergo receptor characterisation via RT-PCR.
16271722|NCT00852488|Procedure|Placement of transthoracic catheter|Placement of transthoracic catheter into the inferior vena cava
16271723|NCT00852475|Dietary Supplement|MUFA MOVE! (Monounsaturated fatty enriched diet)|MUFA MOVE!diet and exercise program
16271724|NCT00852475|Dietary Supplement|PUFA MOVE! (Polyunsaturated fatty acid enriched diet)|PUFA MOVE! diet and exercise program
16271725|NCT00852462|Behavioral|SAMI|Patients and Health care providers use Symptom Assessment and Management Intervention: patient report symptoms by answering validated questionnaires in a secure online program. The system generates a report for providers that displays symptoms and customized suggestions for their clinical management.
16271726|NCT00852449|Other|restrictive and liberal fluid therapy|In both group, when hypovolemia is suspected (peak aortic velocity variation > 13%): fluid bolus (hydroxyethyl starch 130/0.4/6%) according to a predefined algorithm designed to maintain peak aortic velocity < 13% and no further increases in SV
16271727|NCT00852436|Drug|pregabalin|Pregabalin capsules in 75 mg,dosing increment from 150, 300, to 600mg/day at weekly intervals,administered orally one (or two, or four) capsule(s), twice daily. Fixed schedule of dosing increment from 150, 300, to 600mg/day at weekly intervals, until the highest tolerated dose has been reached. A single downward dose titration will be allowed depending on tolerability, after which the patient will remain on this dosage for the rest of the study.
16271728|NCT00852436|Drug|placebo|Placebo capsules in 75 mg,dosing increment from 150, 300, to 600mg/day at weekly intervals,administered orally one (or two, or four) capsule(s), twice daily. Fixed schedule of dosing increment from 150, 300, to 600mg/day at weekly intervals, until the highest tolerated dose has been reached. A single downward dose titration will be allowed depending on tolerability, after which the patient will remain on this dosage for the rest of the study.
16271729|NCT00852423|Drug|Dihydroartemisinin-piperaquine|DHA-PQ tablets are green film coated intended for oral use and contain 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. In this trial the 40/320mg for adults will be used. Developed by Sigma Tau in partnership with Medicines for Malaria Venture.
16271761|NCT00852215|Device|Vision stent|Stenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
16271762|NCT00852202|Drug|cariprazine|Drug: cariprazine (0.25 - 0.75 mg/day)
16271730|NCT00852423|Drug|Artesunate-mefloquine|MQAS will be provided as a fixed-dose ACT. There are 2 strengths (AS25+MQ55mg and AS100+MQ220mg) and dosing regimen is calculated according to 12 mg/kg AS and 24mg/kgMQ total dose over three days. Pregnant women will receive 2 tablets/day for 3 days. It is developed by Farmanguinhos with the Drugs for Neglected Diseases Initiative. To be noted: if the FDCs will not get the WHO pre-qualification before the start of recruitment, the separate AS and MQ will be used
16271731|NCT00852423|Drug|Artesunate-amodiaquine|AQAS, developed by teh DNDi with Sanofi-Aventis and manufactured by Sanofi-Aventis, has been pre-qualified by the WHO in 2008 and is available in several African countries, including those involved in this trial. AQ-AS tablets are round, yellow on one side and white-slightly yellow on the other, with a breaking bar, AS engraved on one side and either 25, 50 or 100 on the other side. Tablets to be used in this trial are those 100mg/270mg AS/AQ, containing 100 mg of artesunate, 352.640 mg of amodiaquine hydrochloride corresponding to 270mg of amodiaquine base.
16271732|NCT00852423|Drug|Artemether-lumefantrine|AL (tablets containing a FDC of 20 mg of artemether and 120 mg of lumefantrine) is manufactured by Novartis and has been extensively used in Africa for the treatment of uncomplicated malaria. AL was registered in Switzerland in 1999, has since received marketing authorisation in several endemic and non-endemic countries and it is WHO pre-qualified.
16271733|NCT00852410|Drug|1% lidocaine with 1:100,000 adrenaline|high dose
16271734|NCT00852410|Drug|1% lidocaine with 1:200,000 adrenaline|1% lidocaine with 1:200,000 adrenaline
16271735|NCT00852397|Drug|Apixaban|Apixaban 2.5 mg tablet BID for 24 weeks
16271736|NCT00852397|Drug|Apixaban|Apixaban 5.0 mg tablet BID for 24 weeks
16271737|NCT00852397|Other|Placebo|Placebo tablet for 24 weeks
16271738|NCT00852384|Procedure|NIPPV and IRM|"non invasive positive pressure support ventilation (NIPPV group)
~alveolar recruitment maneuver (IRM group)"
16271739|NCT00852371|Drug|sulfadoxine-pyrimethamine|25 mg/kg po once on day 0
16271740|NCT00852371|Drug|amodiaquine + sulfadoxine-pyrimethamine|Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
16271741|NCT00852371|Drug|dihydroartemisinin-piperaquine|2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
16271742|NCT00852371|Other|Placebo|dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
16271743|NCT00852358|Drug|laronidase|For the treatment group, intrathecal rhIDU injections will consist of 3 cc of Aldurazyme® (laronidase) (approximately 1.74 mg) diluted with 6 cc of Elliotts B® solution for a total injection of 9 cc. The diluted enzyme will be administered via a lumbar puncture (IT) on day 0 after baseline assessments. IT injections will be repeated on days 30, 60, and 90. The subsequent doses will be administered at 3-month intervals for a total of 10 doses during the two-year period. Control patients will not receive treatment, lumbar puncture, or placebo, but will undergo all other study procedures and assessments during year one. Control patients will then enter a treatment phase consisting of four IT doses at 3-month intervals.
16271744|NCT00852345|Drug|clofazamine|clofazamine 50mg po qday (duration varies according to physician)
16271745|NCT00852332|Dietary Supplement|Curcumin|
16271746|NCT00852332|Drug|Taxotere|
16271747|NCT00852319|Behavioral|Interpregnancy Care|The intervention package includes: 1) Creation of an individualized interpregnancy care plan based on assessments of risks for subsequent poor pregnancy outcomes; 2) Basic dental care and provision of primary health care services for 24 months; 3) Assistance in achieving a woman's desire for subsequent pregnancies and her need for optimum child spacing (ideally at least 18 months); 4) Provision of appropriate social services and community outreach in each woman's community.
16271748|NCT00852319|Behavioral|Interpregnancy Care|The intervention package includes: 1) Creation of an individualized interpregnancy care plan based on assessments of risks for subsequent poor pregnancy outcomes; 2) Basic dental care and provision of primary health care services for 24 months; 3) Assistance in achieving a woman's desire for subsequent pregnancies and her need for optimum child spacing (ideally at least 18 months); 4) Provision of appropriate social services and community outreach in each woman's community.
16271749|NCT00852306|Procedure|oocyte freezing|retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.
16271750|NCT00852293|Other|A blood test|A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.
16271751|NCT00852280|Device|Treatment of 1/2 of skin graft with pulsed-dye laser|Pulsed-dye laser will be applied to 1/2 of the seam of the skin graft, using a 10mm spot size, and sufficient pulse-width and fluency to induce purpura.
16271752|NCT00852267|Other|High Carbohydrate, High Saturated Fat Diet|50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)
16271753|NCT00852267|Other|Low Carbohydrate, High Saturated Fat Diet|31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)
16271754|NCT00852267|Other|Low Carbohydrate, Low Saturated Fat Diet|31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)
16271755|NCT00852241|Drug|Restalyne|one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
16271756|NCT00852241|Drug|Perlane|One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
16271757|NCT00852228|Drug|IV cetuximab|Cetuximab is administered every two weeks at the dose of 500 mg/m² over 2h30 (150 minutes).
16271758|NCT00852228|Drug|HAI chronomodulated chemotherapy|"Irinotecan (180 mg/m²) on day 2 as a 6 hour infusion, starting at 2:00, with a peak at 5:00
~Oxaliplatin (85 mg/m²) in split daily doses for 3 days, starting on day 2. Daily sinusoidal infusion duration will last from 10:15 to 21:45, with peak delivery rate at 16:00.
~5-Fluorouracil (2800 mg/m²) in split daily doses for 3 days, alternating with oxaliplatin infusions, starting on day 2. Daily sinusoidal infusions will last from 22:15 to 9:45 , with peak delivery at 4:00.
~Treatments will be repeated every 2 weeks."
16271759|NCT00852228|Drug|HAI conventional chemotherapy|"Irinotecan (180 mg/m²) on day 1 as a one hour infusion, then
~Oxaliplatin (85 mg/m²) on day 1 as a two hour infusion, then
~5-Fluorouracil (2800 mg/m²) as a 48 h infusion starting on day 2, after completion of oxaliplatin delivery.
~Treatments will be repeated every 2 weeks."
16271760|NCT00852215|Device|Taxus stent|Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
16271764|NCT00852202|Drug|placebo|placebo capsules, oral administration, once daily dosing
16271765|NCT00852189|Drug|EC0489, Injection|PART A: Dose escalation from a starting dose of 1.0 mg/m2 IV bolus on Monday, Wednesday, and Friday Weeks 1 and 3 of a 4-week cycle to the Maximum Tolerated Dose (MTD)
16271766|NCT00852189|Drug|EC20|20-25 mCi 99mTc-EC20 administered IV bolus 1-2 hours prior to imaging and at end of study for subjects who received 1 cycle or more of EC0489.
16271767|NCT00852189|Drug|EC0489, Injection|PART B: Once PART A MTD is determined, PART B will begin. Dose escalation from a starting dose of 4.2 mg/m2 IV bolus once weekly in a 4-week cycle to the Maximum Tolerated Dose (MTD).
16271768|NCT00852163|Drug|Clofarabine with Busulfan|Clofarabine 40 mg/m2 IV QD × 5 days Busulfan (Busulfex™) 3.2 mg/kg IV QD × 2 days
16271769|NCT00852137|Drug|PEP005 (ingenol mebutate) Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
16271770|NCT00852137|Drug|Vehicle Gel|Vehicle Gel once daily for 2 consecutive days
16271771|NCT00852124|Biological|VSL#3|VSL#3 2 times daily
16271772|NCT00852124|Biological|VSL#3 or placebo|1 packet 2 x daily of placebo
16271773|NCT00852098|Procedure|Lap Nissen fundoplication with division of short gastric vessels|Dividing short gastric vessels
16271774|NCT00852098|Procedure|Laparoscopic Nissen fundoplication without division of short gastric vessels|non-dividing short gastric vessels
16271775|NCT00852085|Behavioral|Enhanced community service|Two educational sessions and volunteering at a local community service site
16271776|NCT00852085|Behavioral|Group MI|Four group counseling sessions and two directed observational visits to an emergency department
16271777|NCT00852072|Procedure|Single-operator cholangioscopy-guided laser lithotripsy|Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
16271778|NCT00852072|Procedure|Balloon Sphincteroplasty|Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy
16271779|NCT00852059|Drug|Immediate release methylphenidate (Medikinet®)|Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
16271780|NCT00852059|Drug|Extended release methylphenidate (Medikinet retard®)|Treatment: methylphenidate applied with breakfast(once daily), extended release
16271781|NCT00852046|Drug|Dexmedetomidine|IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
16271782|NCT00852033|Behavioral|Brief Motivational Intervention (BMI)|Students met with trained interventionists. The initial BMI took place during the fall semester of the freshmen year for approximately 45 minutes. Individualized feedback was used to guide the BMI sessions. The feedback data were gathered through an online survey completed within two weeks of the scheduled appointment to ensure the use of proximal feedback reflecting current drinking. Feedback was tailored so that drinkers received information on their personal drinking patterns, heavy episodic drinking, and alcohol-related consequences, and abstainers received feedback on their perceived barriers for maintaining abstinence, the safety and health benefits of their choice not to drink, and their experience with second-hand effects of alcohol use. In the spring of the freshmen year, students received a BMI 'booster' session. Individualized feedback was created from the original online survey and the 10 month follow-up assessment.
16271783|NCT00852033|Behavioral|Parent Based Intervention plus booster|The PBI is a handbook-based intervention modified from Turrisi and colleagues (2001). It was designed to raise parental awareness of alcohol abuse and consequences among college students and increase parental effort to address this issue with their teen.
16271784|NCT00852033|Behavioral|Combined brief motivational intervention and parent based intervention plus boosters for both interventions|A combination of Intervention 1 and 2.
16271785|NCT00852033|Other|Assessment only|No intervention, assessment only.
16271786|NCT00852020|Dietary Supplement|oral nutrition supplement, food for special medical purposes|2 servings of 200-300 ml per day, treatment period: 16 weeks
16271787|NCT00852007|Biological|DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1|1.2 x 10e7 dendritic cells per dose. One dose delivered intradermally (i.d.) and into a node (i.n.). Two weeks after this,two injections i.d. 2 weeks apart. Optional booster injections at 6 (i.d. and i.n.) and and 12 months (i.d.).
16271788|NCT00851981|Other|Placebo|TID
16271789|NCT00851981|Dietary Supplement|SAMe|300 mg TID
16271790|NCT00851968|Procedure|Pringle's Maneuver|The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.
16271791|NCT00851968|Procedure|Hemihepatic vascular Clamping|The portal vein,hepatic artery ,and biliary duct were dissected in the hilum by opening the peritoneal fascia. Either the right or left portal pedicle was isolated and encircled with a tourniquet or clamped with Shatinsky clamp. Separate clamping of accessory left hepatic artery was performed when present in controlling the left hemihepatic portal traid.
16271792|NCT00851968|Procedure|Portal vein occlusion|The proper hepatic artery was dissected first from the duodenohepatic ligament, portal pedicle was blocked with a rubber encircled through the posterior wall of proper hepatic artery and the bottom of duodenohepatic ligament.When aberrant hepatic arteries emerging from the superior mesenteric artery are found in duodenohepatic ligament ,they should be dissected and kept unobstructed.
16271793|NCT00851942|Drug|Synacthen (Tetracosactrin)|IV injection of 250 micrograms of Synacthen in 1ml
16271794|NCT00851929|Drug|Ambrisentan|ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
16271795|NCT00851916|Radiation|CyberKnife Radiosurgery|CyberKnife Radiosurgery
16271796|NCT00851903|Drug|Insulin Glargine|Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
16271797|NCT00851903|Drug|Sitagliptin|Oral administration. 100mg film-coated tablets.
16271798|NCT00851903|Drug|Metformin|Patients continued with metformin as usual oral anti-diabetic treatment.
16271799|NCT00851890|Drug|ABT-333|50 mg capsules
16271800|NCT00851890|Other|Placebo for ABT-333|Capsule
16271801|NCT00851890|Drug|Pegylated interferon|Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
16271802|NCT00851890|Drug|Ribavirin|200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
16271803|NCT00851877|Biological|Cetuximab|Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor
16271804|NCT00851877|Drug|Cisplatin|Cisplatin is an anti-cancer chemotherapy drug
16271805|NCT00851877|Drug|Nab-Paclitaxel|paclitaxel albumin-stabilized nanoparticle formulation
16271806|NCT00851877|Radiation|intensity-modulated radiation therapy|intensity-modulated radiation therapy
16271807|NCT00851864|Drug|Tinzaparin|"LMWH (tinzaparin-Innohep, Leo Pharma A/S) 175 anti-factor Xa units per kilogram of body weight sub-cutaneously once daily.
~Treatment will be done for the duration of the pregnancy."
16271808|NCT00851838|Drug|L-Carnitine|Instillation of glucose-based (1.5 or 2.5 w/v) PD solution containing L-carnitine during the nocturnal exchange in APD treated patients. L-Carnitine (0.1% w/v) is present only in the first 5 Liter APD bag. PD solutions are instilled for 5 days.
16271809|NCT00851812|Behavioral|Exercise|Standard care monitoring
16271810|NCT00851812|Behavioral|Progressive walking and resistance exercise treatment|Home-based exercise : Progressive walking and resistance program
16271811|NCT00851799|Drug|Emtricitabine/tenofovir disoproxil fumarate|"200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
~Other Name: TDF/FTC"
16271812|NCT00851799|Drug|Ritonavir|"100 mg taken orally once daily. A protease inhibitor (PI).
~Other Name: RTV"
16271813|NCT00851799|Drug|Atazanavir|"300 mg taken orally once daily. A protease inhibitor (PI).
~Other Name: ATV"
16271814|NCT00851799|Drug|Raltegravir|"400 mg taken orally twice daily. An integrase inhibitor (INI).
~Other Name: RAL"
16271815|NCT00851799|Drug|Darunavir|"100 mg taken orally once daily. A protease inhibitor (PI).
~Other Name: RTV"
16271816|NCT00851786|Biological|ZOSTAVAX|Subcutaneous injection of 0.65 mL of ZOSTAVAX at Day 0 and Week 6
16271817|NCT00851786|Biological|Placebo|Subcutaneous injection of 0.65 mL of placebo at Day 0 and Week 6
16271818|NCT00851773|Drug|semaglutide|0.1 mg once weekly, s.c. injection
16271819|NCT00851773|Drug|semaglutide|0.2 mg once weekly, s.c. injection
16271820|NCT00851773|Drug|semaglutide|0.4 mg once weekly, s.c. injection
16271821|NCT00851773|Drug|semaglutide|0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
16271822|NCT00851773|Drug|semaglutide|0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
16271823|NCT00851773|Drug|placebo|0.1 mg once weekly, s.c. injection
16271824|NCT00851773|Drug|placebo|0.2 mg once weekly, s.c. injection
16271825|NCT00851773|Drug|placebo|0.4 mg once weekly, s.c. injection
16271826|NCT00851773|Drug|placebo|0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
16271827|NCT00851773|Drug|placebo|0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection
16271828|NCT00851760|Procedure|Consecutive surgery|Consecutive surgery for epiretinal macular membrane and cataract extraction
16271829|NCT00851760|Procedure|Combined surgery|Combined surgery for epiretinal macular membrane and cataract extraction
16271830|NCT00851747|Drug|Phosphatidylcholine Deoxycholate|Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections
16271831|NCT00851747|Drug|Saline|Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections
16271832|NCT00851734|Drug|voclosporin ophthalmic solution|0.02%, 0.2% t.i.d. or b.i.d.
16271833|NCT00851721|Biological|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)|85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
16271834|NCT00851721|Biological|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)|FEIBA NF dose and dosing interval as prescribed by the treating physician
16271835|NCT00851708|Drug|N-acetylcysteine|600 mg bid orally from day 1 to 7 postoperative
16271836|NCT00851682|Device|MRI scan|Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
16271837|NCT00851669|Behavioral|Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)|Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression
16271838|NCT00851669|Behavioral|Treatment as Usual|Individual psychotherapy following usual care practice in a chemical dependency treatment program.
16271839|NCT00851643|Biological|Octavalent HPV with 15 mcg IMX / AAHS|0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
16271840|NCT00851643|Biological|Octavalent HPV with 30 mcg IMX / AAHS|0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
16271841|NCT00851643|Biological|Octavalent HPV with 60 mcg IMX / AAHS|0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
16271842|NCT00851643|Biological|Octavalent HPV with 120 mcg IMX / AAHS|0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
16271843|NCT00851643|Biological|Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)|0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
16271844|NCT00851630|Drug|Fixed dose combination zidovudine/lamivudine/abacavir|All subjects will receive fixed dose combination zidovudine(300 mg) / lamivudine (150 mg) / abacavir (300 mg) by mouth twice daily. Medications will be provided as long as deemed beneficial by the site investigator and study subject for up to two years. Toxicity substitutions are allowed per protocol.
16271845|NCT00851617|Device|Threshold® IMT|The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day
16271846|NCT00851591|Drug|fenugreek|3 capsules 3 times per day with a full glass of water each dose for 7 days
16271847|NCT00851591|Drug|Placebo (Psyllium)|3 capsules 3 times a day with a full glass of water each dose for 7 days
16271848|NCT00851578|Device|WATCHMAN|WATCHMAN LAA Closure Device
16271941|NCT00850954|Other|Informational Intervention|Receive information on secondhand smoke and supporting smoker in quitting
16273479|NCT00838903|Drug|placebo glimepiride|placebo to match glimepiride
16271849|NCT00851565|Procedure|Measurement of serum infliximab and anti-infliximab antibodies|"In the intervention group treatment of patients with Crohn's disease with secondary loss of response to infliximab is based on serum infliximab and anti-infliximab Ab levels according to following algorithm:
~Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks.
~Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg/kg i.v. every 8 weeks.
~High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery.
~High s-infliximab in the presence of anti-infliximab Ab: Same as number 3."
16271850|NCT00851565|Procedure|Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status|In the control group patients with Crohn's disease with secondary loss of response to infliximab is treated according to current standard of care which is to increase dose of infliximab to 5 mg/kg every 4 weeks without knowledge of serum infliximab levels and anti-infliximab Ab status.
16271851|NCT00851552|Biological|rituximab|Given IV
16271852|NCT00851552|Drug|bortezomib|Given IV
16271853|NCT00851552|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16271854|NCT00851552|Genetic|gene expression analysis|Correlative Study
16271855|NCT00851552|Genetic|polymerase chain reaction|Correlative Study
16271856|NCT00851552|Genetic|polymorphism analysis|Correlative Study
16271857|NCT00851552|Genetic|proteomic profiling|Correlative Study
16271858|NCT00851552|Other|flow cytometry|Correlative Study
16271859|NCT00851552|Other|laboratory biomarker analysis|Correlative Study
16271860|NCT00851539|Behavioral|Video|Behavioral Intervention Video
16271861|NCT00851513|Drug|Lidocaine|local anesthetics
16271862|NCT00851513|Drug|Depmedrol|local steroids
16271863|NCT00851513|Other|physiological serum|important volumes of physiological serum
16271864|NCT00851500|Drug|K-604|K-604 is given for 26 weeks
16271865|NCT00851500|Other|Placebo|placebo tablets are given for 26 weeks
16271866|NCT00851487|Drug|Amoxicillin|Oral Amoxicillin 15 mg/kg/dose 8 hourly
16271867|NCT00851487|Drug|Placebo|The placebo was similar in colour, consistency and volume as oral amoxicillin
16271868|NCT00851461|Drug|Goserelin|Goserelin 10.8 mg SC every 3 months
16271869|NCT00851461|Procedure|Electrophysiologic study|Nerve conduction study Electromyogram
16271870|NCT00851461|Procedure|tissue biopsy|skin and muscle biopsy before and after treatment every year
16271871|NCT00851448|Dietary Supplement|oral nutritional supplement, food for special medical purposes|2 servings of 200-300 ml per day, treatment period: 16 weeks
16271872|NCT00851435|Biological|KBPA-101|1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day
16271873|NCT00851409|Drug|Recombinant Human C1 Inhibitor|"50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
16271874|NCT00851383|Biological|Ad35-GRIN/ENV|This is a dose-escalation trial. Each group will receive the Ad35-GRIN/ENV vaccine at different dosage levels.
16271875|NCT00851383|Biological|Ad35-GRIN|This is a dose-escalation trial. Group D will receive the Ad35-GRIN vaccine.
16271876|NCT00851370|Drug|Omalizumab (Xolair)|Bi-weekly
16271877|NCT00851370|Drug|Placebo|Bi-Weekly
16271878|NCT00851357|Drug|Nicotine Patch|Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
16271879|NCT00851357|Behavioral|Telephone Counseling|"Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
~Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling."
16271880|NCT00851357|Drug|Placebo|Placebo nicotine patch
16271881|NCT00851357|Other|Self-Help Materials|"Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
~Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day."
16271882|NCT00851344|Drug|GSK835726 (10mg)|GSK835726 (10mg) tablet
16271883|NCT00851344|Drug|GSK835726 (50mg)|GSK835726 (50mg) tablet
16271884|NCT00851344|Drug|GSK835726 (100mg)|GSK835726 (100mg) tablet
16271885|NCT00851344|Drug|Cetirizine (10mg)|Cetirizine (10mg) tablet as positive control
16271886|NCT00851344|Other|Placebo|Placebo to match active
16271887|NCT00851331|Genetic|genome analyzes (genetic defects and pathophysiological mechanisms )|
16271888|NCT00851318|Drug|Certolizumab pegol|Subcutaneous (SC) injection
16271889|NCT00851318|Drug|Methotrexate|Methotrexate dose between 6 to 8 mg/week.
16271890|NCT00851305|Device|Endomicroscope (Pentax, Tokyo, Japan)|A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.
16271891|NCT00851305|Device|Gastroscopes (Pentax, Tokyo, Japan)|Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
16271892|NCT00851292|Device|TRUS probe|end-firing and side-firing vary in the angle in which they sample the prostate
16271893|NCT00851279|Device|Magnetic irrigated ablation catheter|Magnetic irrigated catheter to be used with the magnetic navigation system
16271942|NCT00850954|Behavioral|Smoking Cessation Intervention|Receive smoking cessation materials based on TTM
16271943|NCT00850954|Other|Survey Administration|Ancillary studies
16271944|NCT00850941|Behavioral|Questionnaire|Information collection.
16271894|NCT00851266|Biological|V512|"Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6:
~1) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX;"
16271895|NCT00851266|Biological|Comparator: Placebo to V512|Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6.
16271896|NCT00851253|Radiation|stereotactic radiosurgery|Given in 2 fractionated doses or 5 fractionated doses
16271897|NCT00851240|Drug|BTT-1023|intravenous
16271898|NCT00851240|Drug|Placebo|Intravenous
16271899|NCT00851227|Drug|conivaptan hydrochloride|intravenous
16271900|NCT00851214|Device|NexfinHD Monitor|Finger cuff device (NexfinHD Monitor, BMEYE, Amsterdam) that can measure hemodynamics on a beat to beat basis and that can be easily applied to acutely ill individuals.
16271901|NCT00851201|Behavioral|Intensive lifestyle|"The intensive lifestyle intervention will include the standard intervention plus 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a toolbox approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups."
16271902|NCT00851201|Behavioral|Standard intervention|The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2) quarterly follow-up, 3) and a monthly newsletter.
16271903|NCT00851188|Behavioral|Internet CBT self-help|Internet based Cognitive behavioral self-help method for insomnia
16271904|NCT00851188|Behavioral|CBT self-help booklet|Cognitive behavioral self-help method for insomnia via booklet
16271905|NCT00851188|Other|Waiting list|Waiting list
16271906|NCT00851175|Drug|rosuvastatin|7 day treatment with rosuvastatin 1dd 20mg
16271907|NCT00851175|Drug|caffeine|intra-arterial (brachial artery of non dominant arm) administration of caffeine(90 ug/min/100ml forearm volume)for approximately 60 minutes
16271908|NCT00851162|Biological|Trinity multipotent stem cells|Enough to fill voids which vary in size
16271909|NCT00851162|Biological|Demineralized bone matrix(DBM)|Enough DBM to fill a bone void defect
16271910|NCT00851149|Device|Sangvia blood sampling system|Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
16271911|NCT00851136|Drug|bevacizumab|Intravenous repeating dose
16271912|NCT00851136|Drug|FOLFOX|Intravenous repeating dose
16271913|NCT00851136|Drug|PRO95780|Intravenous repeating dose
16271914|NCT00851123|Behavioral|Modified Constraint-Induced Movement therapy|Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day.
16271915|NCT00851123|Behavioral|Task-specific bimanual training|Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own.
16271916|NCT00851110|Procedure|stem cell reinfusion|hematopoietic stem cell reinfusion
16271917|NCT00851110|Drug|Chemotherapy|High-dose chemotherapy consisting of cyclophosphamide, thiotepa and carboplatin
16271918|NCT00851084|Drug|aflibercept|administration: IV infusion
16271919|NCT00851084|Drug|oxaliplatin|administration: IV infusion
16271920|NCT00851084|Drug|5-FU|administration: IV infusion
16271921|NCT00851084|Drug|Folinic Acid|administration: IV infusion
16271922|NCT00851071|Behavioral|Cognitive Behavioral Therapy|Three 45 minute CBT sessions scheduled over a 3 month period.
16271923|NCT00851058|Behavioral|Brief group counseling|Four group counseling sessions and six hours of direct observations of the emergency and trauma services in a busy urban hospital.
16271924|NCT00851058|Behavioral|Community Counseling|Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital
16271925|NCT00851058|Behavioral|Prototypic community service|Two educational session on road safety and 16 hours of volunteering in a local not for profit community service.
16271926|NCT00851058|Behavioral|Prototypic community service|Four hours education about road safety and 16 hours volunteering at a local not for profit community service
16271927|NCT00851045|Drug|Irinotecan|Solution, IV, 180 mg/m2, Q14 days, Until PD
16271928|NCT00851045|Drug|5-Fluorouracil (bolus)|Solution, IV, 400 mg/m2, Q14 days, Until PD
16271929|NCT00851045|Drug|5-Fluorouracil (infusional)|Solution, IV, 2400 mg/m2, Q14 days, Until PD
16271930|NCT00851045|Drug|Leucovorin calcium|Solution, IV, 400 mg/m2, Q14 days, Until PD
16271931|NCT00851045|Drug|CT-322|Solution, IV, 2 mg/kg, Q7 days, Until PD
16271932|NCT00851045|Drug|Bevacizumab|Solutions, IV, 5 mg/kg, Q14 days, Until PD
16271933|NCT00851045|Drug|Bevacizumab Placebo (saline solution)|Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
16271934|NCT00851032|Other|Molecular Profiling Analyses|Molecular profiling analyses from advanced cancer participants' stored tissue bank samples.
16271935|NCT00851019|Behavioral|DDR|"Ad libitum attendance to engage in Dance Dance Revolution (DDR) Exergaming, for a 3-month period"
16271936|NCT00851019|Behavioral|Treadmill|Ad libitum attendance to engage in treadmill exercise, for a 3-month period
16271937|NCT00851006|Drug|Creatine Monohydrate|Creapure brand of creatine monohydrate
16271938|NCT00850993|Drug|Stannsoporfin|Stannsoporfin administered as a single IM injection
16271939|NCT00850993|Other|Placebo|Placebo (sterile saline solution) administered as a single IM injection
16271940|NCT00850993|Other|PhotoTherapy (as needed)|PT standard care administered as needed, based on bilirubin levels throughout the treatment period
16272062|NCT00849862|Drug|Levetiracetam|750 mg Tablet
16271945|NCT00850915|Other|community IPT|"In the intervention group, the household contacts of enrolled TB/HIV co-infected patient are visited at home by community health workers. Those contacts providing informed consent and considered fit (assessed by simple questionnaire) are assumed not to have active TB and are eligible for IPT. They are offered isoniazid at 300mg (5 mg per Kg for children) once daily for 6 months, regardless of their HIV-status.
~In the control group, in line with routine care, eligible index cases are requested to send their contacts to the clinic for evaluation. Contacts presenting to the clinic will be screened for TB and receive IPT, if under 5 years and when active TB is ruled out as per the current national guidelines.
~All contacts (both intervention and control group) are followed up monthly to assess occurrence of symptoms suggestive of TB."
16271946|NCT00850902|Other|High Humidity (HH)|High Humidity Level
16271947|NCT00850902|Other|Moderate Humidity|Moderate Humidity Level
16271948|NCT00850889|Device|Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine|Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
16271949|NCT00850889|Device|A gel of hyaluronic acid (concentration of 20 mg/mL)|Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
16271950|NCT00850850|Drug|physostigmine|1 mg of physostigmine time 0 min. If the condition persisted after 15 min. the same amount of active drug would be administered once again.
16271951|NCT00850850|Drug|Isotonic sodium chloride solution|Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo) time 0 min. If the condition persisted after 15 min. the same amount of non-active drug would be administered once again.
16271952|NCT00850837|Drug|Acidform Lubricant|5 g application of acid buffered gel (pH = 3.5)
16271953|NCT00850837|Drug|HEC gel|5 g application of hydroxyethylcellulose gel
16271954|NCT00850824|Behavioral|Community Health Worker home visits|Community health workers will educate diabetes patients and families about need for regular medical care, taking medications, increasing exercise patterns, improving diet, keeping medical referral exams for specialty.
16271955|NCT00850811|Drug|PEP005 (ingenol mebutate) Gel|PEP005 (ingenol mebutate) Gel, 0.01%
16271956|NCT00850798|Drug|Intensive glycemic control|Intensive glycemic control
16271957|NCT00850798|Drug|Conservative glycemic control|OADs and insulin
16271958|NCT00850785|Biological|DRibble vaccine|Docetaxel 75 mg/m2 will be administered in the several days after leukapheresis. Intradermal (ID) vaccine injections of DRibbles made from at least 5 million and up to 20 million cell equivalents per vaccination will begin 14 days after the first docetaxel. Each DRibble vaccine will be followed by the 6-day infusion of GM-CSF via the CADD-MS 3 pump (50 micrograms/24 hrs).
16271959|NCT00850772|Dietary Supplement|Early post-operative enteral feeding|During primary surgical treatment an enteral feeding tube will be inserted through the patient's nose into their small bowel. Enteral feeding will commence 4 hours following return to ward from surgery. Feeding will start at a rate of 40 ml/hr for the first 24 hours, and then increased to goal weight. Goal will be calculated by 125 kiloJoules/kilogram adjusted body weight.
16271960|NCT00850759|Device|virtual pedestrian environment|a computer-driven virtual pedestrian environment
16271961|NCT00850759|Device|computer and video|various computer-based and video-based programs such as Otto the Auto and WalkSafe
16271962|NCT00850759|Behavioral|streetside training|one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills
16271963|NCT00850746|Drug|YM443|Oral
16271964|NCT00850746|Drug|Placebo|Oral
16271965|NCT00850746|Drug|Moxifloxacin|Oral
16271966|NCT00850720|Other|Blood draws|Samples of blood to be drawn before surgery, and nine hours after surgery.
16271967|NCT00850681|Drug|PEP005 (ingenol mebutate) Gel|PEP005 (ingenol mebutate) Gel, 0.01%
16271968|NCT00850668|Biological|E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3|Up to 7 mL solution administered rectally
16271969|NCT00850642|Drug|GSK2190195 100mg|GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.
16271970|NCT00850642|Drug|Placebo|"Placebo :
~2% (w/w) Ethanol, sucralose (5 mg/100 mL of oral solution) to 100 % (w/w) aqueous sodium carbonate buffer (0.010 M, pH 9-10)"
16271971|NCT00850629|Behavioral|multimodal lifestyle intervention|After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
16271972|NCT00850629|Behavioral|placebo|no intervention, only follow up
16271973|NCT00850616|Biological|V526|0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
16271974|NCT00850616|Biological|Comparator: Placebo to V526|0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.
16271975|NCT00850603|Biological|Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined|0.5 mL, Subcutaneous
16271976|NCT00850603|Biological|Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined|0.1 mL, Subcutaneous
16271977|NCT00850603|Biological|Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined|0.05 mL, Intradermal
16271978|NCT00850603|Biological|Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined|0.1 mL, Intradermal
16271979|NCT00850603|Biological|Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined|0.15 mL, Intradermal
16271980|NCT00850590|Drug|NRL001|Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g.
16271981|NCT00850577|Drug|Paclitaxel|Solution, IV, 200 mg/m2, Q21days, 6 cycles
16271982|NCT00850577|Drug|Carboplatin|Solution, IV, AUC=6, Q21days, 6 cycles
16271983|NCT00850577|Drug|CT-322|Solution, IV, 2 mg/kg, Q7days, Until PD
16271984|NCT00850577|Drug|Bevacizumab|Solution, IV, 15 mg/kg, Q21days, Until PD
16271985|NCT00850577|Drug|Bevacizumab placebo (ie saline solution)|Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
16271986|NCT00850564|Drug|Growth Hormone Releasing Hormone (Tesamorelin)|Tesamorelin 2mg subcutaneous daily x 2 weeks
16271987|NCT00850551|Other|Early Intervention|Twice a week home spirometry and symptom assessment
16271988|NCT00850538|Radiation|MRI|1.5T MRI exam of signal knee with knee coil (estimated time: 35 minutes)
16272063|NCT00849862|Drug|Keppra®|750 mg Tablet
16271989|NCT00850538|Procedure|Primary Total Knee Replacement|Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.
16271990|NCT00850512|Drug|CHOP21-R|Four months for CHOP21-R and two treatment days one week apart
16271991|NCT00850512|Drug|Zevalin|12-week safety period for Zevalin
16271992|NCT00850499|Drug|fludarabine|fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
16271993|NCT00850499|Drug|rituximab|rituximab 375mg/m2 on Day 1 of every 35-day cycle
16271994|NCT00850499|Drug|VELCADE|1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
16271995|NCT00850486|Device|Exercise test with HyperQ technology|High frequency components of the QRS complex within the ECG signal are analyzed off-line to provide an indication of ischemia induced depolarization abnormalities
16271996|NCT00850473|Diagnostic Test|PET/CT|Patient will have one imaging modality - a Positron Emitting Tomography CT which includes F-18 FDG and heparin/intralipid infusion and Contrast Dye.
16271997|NCT00850460|Drug|Statins|Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.
16271998|NCT00850460|Drug|Placebo|Placebo pills will consist of lactose and will be given one capsule once daily
16271999|NCT00850447|Other|Cognitive Remediation Therapy|Cognitive Remediation Therapy (CRT) is a standardized intervention that involves performing cognitive exercises to improve attention, processing speed, and memory through practice. Participants will have one 60-minute CRT session each week for ten weeks. The CRT to be used in the proposed study is CogPack (version 6.0 Marker Software, Mannheim Germany). CogPack demonstrates flexibility in terms of developing a targeted intervention plan based on the levels of baseline cognitive impairment. There are approximately 6 different exercises presented in each training session, with the starting level of difficulty individualized on the basis of baseline neuropsychological performance.
16272000|NCT00850447|Other|Videogame|Participants will play the videogame Tetris once each week for 30 minutes. Tetris is a video puzzle game that involves manipulating falling shapes. The object of the game is to manipulate these shapes, by moving them sideways or rotating them, to create a horizontal line of blocks without gaps. As the game progresses, the shapes fall faster.
16272001|NCT00850434|Device|Modified AutoSet Algorithm|"The modified AutoSet algorithm responds to more patient non-normal flow types than the standard AutoSet algorithm"
16272002|NCT00850434|Device|Standard AutoSet Algorithm|The standard AutoSet used for treatment of OSA
16272003|NCT00850421|Drug|Botulinum Toxin Type A|100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
16272004|NCT00850408|Procedure|Repetitive Transcranial Magnetic Stimulation|For real rTMS,1200 pulses will be delivered at a frequency of 1Hz, with an intensity equal to the 115% of the motor threshold as established at baseline. For Sham rTMS, procedures will be identical to those used for real rTMS with the exception that a placebo coil will be used, which provides acoustic and sensory stimulation like the real coil but does not stimulate neural tissue. 20-minute Real and Sham stimulation sessions will be administered bi-weekly for a period of 4 weeks
16272005|NCT00850395|Drug|maraviroc|No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
16272006|NCT00850382|Drug|Dasatinib|"Induction cycle(s):
~Dasatinib 100 mg QD on days 8-21.
~Consolidation Cycles 1, 2, 3, 4:
~Patients will receive dasatinib 100 mg QD on days 6-28.
~Maintenance therapy:
~Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse)."
16272007|NCT00850382|Drug|daunorubicin|"Induction cycle(s):
~Daunorubicin 60 mg/m2/day administered on days 1 through 3"
16272008|NCT00850382|Drug|Cytarabine|"Induction cycle(s):
~Cytarabine 200 mg/m2/day administered by continuous IV infusion daily for 7 days (days 1 through 7).
~Consolidation cycles 1, 2, 3, 4:
~Consolidation therapy consists of high-dose cytarabine 3 g/m2 (>60 years: 1 g/m2) q12h, d 1, 3, 5, administered intravenously over three hours."
16272009|NCT00850369|Other|RBC transfusion|Study subjects will receive monthly transfusions with 2 units of red blood cells
16272010|NCT00850343|Drug|Certolizumab pegol|Subcutaneous (SC) injection
16272011|NCT00850330|Other|on line software to detect DI early on|Patients hospital records will be reviewed on the day of admission to assess all their indication using on line software to early detect drug interactions.
16272012|NCT00850304|Drug|Cytosar|Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle
16272013|NCT00850304|Drug|Arsenic trioxide|Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
16272014|NCT00850278|Other|FLT-PET imaging|Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
16272015|NCT00850265|Device|Volumatic spacer|A spacer is a plastic device to inhaler medication
16272016|NCT00850252|Device|Lifeline|Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
16272017|NCT00850239|Drug|dutogliptin|400 mg
16272018|NCT00850239|Drug|placebo|
16272019|NCT00850226|Behavioral|CT|Cognitive Therapy Intervention: Subjects receiving the CT strategies will be taught to restructure their negative thoughts to make them more positive, based on the concept that thoughts are linked to their problems with test anxiety because beliefs can cause strong powerful emotions and behaviors. Subjects will be taught not to blame their environments for emotional and behavioral responses, and they will be shown how to change their beliefs in order to affect their emotions and their behaviors.
16272020|NCT00850226|Behavioral|ACT|Acceptance-and-Commitment Therapy Intervention: Subjects receiving the ACT strategies will be taught to defuse from their anxiety (or recognize that their thoughts are just thoughts). They will be taught to accept their anxiety and to learn to live with anxiety. Subjects will be told that while they cannot control the occurrence of their thoughts, they can control whether or not they choose to view them as separate from the self versus part of the self.
16272021|NCT00850213|Device|Endeavor Resolute Stent|Single implantation
16272022|NCT00850200|Radiation|Proton Radiation Plan|Between 21-39.6 Gy/CGE to the PTV
16272023|NCT00850200|Radiation|Conventional Photon Radiation Plan|Between 21-39.6 Gy/CGE to the PTV
16272024|NCT00850200|Radiation|Intensity Modulated Radiation Plan|Between 21-39.6 Gy/CGE to the PTV
16272097|NCT00849615|Drug|Oxaliplatin|85mg/m2 qd15
16272098|NCT00849615|Drug|folinic acid|200mg/m2 qd15
16272025|NCT00850187|Biological|Bone marrow derived mesenchymal stem cells|Bone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells
16272026|NCT00850174|Drug|Oxcarbazepine|600 mg Tablet
16272027|NCT00850174|Drug|Trileptal®|600 mg Tablet
16272028|NCT00850161|Drug|aspart|Meal-time insulin. Administered subcutaneously based on routine clinical therapy.
16272029|NCT00850161|Drug|Nasulin™|100 IU(2 puffs in each nostril)
16272030|NCT00850148|Procedure|Anwar|Anwar surgical method
16272031|NCT00850148|Procedure|Melles|Melles surgical method
16272032|NCT00850135|Device|The Seven Continuous Glucose Monitoring System|Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
16272033|NCT00850122|Drug|cefazolin|"Cefazolin dosing - administered for 48 hours Dosage
~≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8"
16272034|NCT00850096|Other|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
16272035|NCT00850096|Drug|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
16272036|NCT00850070|Drug|sapropterin|Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks
16272037|NCT00850070|Drug|Placebo|Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.
16272038|NCT00850057|Biological|Intranodal injection of Ad-ISF35|Ad-ISF35, a replication-defective recombinant type V adenovirus encoding a recombinant humanized CD154 homolog (ISF35).
16272039|NCT00850044|Drug|ABT-450|capsules,QD, one dose, see Arm Descriptions for more information
16272040|NCT00850044|Drug|ritonavir|capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
16272041|NCT00850044|Drug|placebo for ABT-450|capsules, QD, one dose
16272042|NCT00850044|Drug|Placebo for ritonavir|capsules, QD, one dose
16272043|NCT00850031|Device|AcuFocus Corneal Inlay|Inlay implanted in cornea for improvement of near vision
16272044|NCT00850018|Procedure|Monthly blood transfusion regimen|Participants will receive blood transfusions at 3- to 4-week intervals for 6 months for the treatment of SCD-related anemia; the total number of transfusions that participants will receive will vary between six and eight.
16272045|NCT00850018|Behavioral|Usual care|Participants will receive usual care for the treatment of SCD.
16272046|NCT00850005|Biological|Intravenous immunoglobulin|2 g/kg divided over five days
16272047|NCT00850005|Biological|Normal Saline|Same volume as experimental arm
16272048|NCT00849992|Drug|Imiquimod 5%|Imiquimod 5% cream used three days a week for 4 weeks
16272049|NCT00849992|Procedure|Photodynamic therapy|Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.
16272050|NCT00849979|Behavioral|Questionnaire|Day 1 MDASI-GI Questionnaire
16272051|NCT00849979|Other|Interview|Open-ended, audiotaped interviews
16272052|NCT00849966|Drug|Celebrex suspension|"Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.
~All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO."
16272053|NCT00849966|Drug|Placebo|"Patients will be randomized to receive placebo by mouth one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of the placebo to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.
~All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO."
16272054|NCT00849940|Device|CAS NIRS FORE-SIGHT oximeter|Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
16272055|NCT00849901|Drug|duloxetine|30-120 mg, PO, QD, for up to 38 weeks
16272056|NCT00849901|Drug|Placebo|Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks
16272057|NCT00849901|Drug|fluoxetine|10-40 milligram (mg), PO, QD, for up to 38 weeks
16272058|NCT00849888|Biological|Serum Free Thymus Transplantation with Immunosuppression|Cyclosporine pre-transplant (trough 180-220ng/ml) until naive T cells develop. Subjects >4,000/cumm T cells, pre-transplant methylprednisolone or prednisolone 1-2mg/kg/day. All subjects pre-transplant days -5,-4,-3: 3 doses 2mg/kg rabbit anti-thymocyte globulin. Thymus tissue (unrelated donor), donor, & donor's mother screened for safety. Transplant under general anesthesia into quadriceps. First 2 subjects, FBS cultured thymus is transplanted in 1 leg & serum free (SF) in other. After first 2 subjects >10% naïve T cells, 3rd receives only SF thymus. After 3rd subject >10%naive T cells, 4th subject transplanted. Thymus dose 4-18 grams/m2 body surface area. Thymus biopsy 8-12 weeks post-transplant. Skin biopsy at time of transplant & thymus biopsy. Followed by immune evaluations.
16272059|NCT00849888|Other|Serum Free Thymus Transplantation without immunosuppression|Thymus tissue (unrelated donor), donor, & donor's mother screened for safety. Transplant under general anesthesia into quadriceps. First 2 subjects: FBS cultured thymus transplanted in 1 leg & serum free cultured thymus in other leg. After first 2 subjects have thymopoiesis in serum-free biopsy, >10% naïve T cells, 3rd subject receives only serum free cultured thymus. After 3rd subject >10% naive T cells, 4th subject receives transplant of only serum free cultured thymus. Dose 4-18grams/m2 body surface area. At time of transplant, skin biopsy. Allograft biopsy & skin biopsy done 8 to 12 weeks post-transplant. (Graft biopsy not done if subject medically unstable.) Post-transplant, subjects followed by immune evaluations, using blood samples, for two years.
16272060|NCT00849875|Biological|Immunotherapeutic GSK2132231A|Intramuscular administration
16272061|NCT00849875|Drug|Dacarbazine|Intravenous administration Chemotherapy
16272064|NCT00849823|Behavioral|Male Sexual Health Program|"An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size fits all condoms) and a brief (nurse-delivered) counseling message to practice safer sex."
16272065|NCT00849823|Behavioral|Focus on the Future Program|A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.
16272066|NCT00849810|Drug|Metoprolol|Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks
16272067|NCT00849810|Drug|Nebivolol|5 - 20 mg daily, at a stable dose for 4 to 5 weeks
16272068|NCT00849797|Drug|Oxcarbazepine|600 mg Tablet
16272069|NCT00849797|Drug|Trileptal®|600 mg Tablet
16272070|NCT00849745|Procedure|Nonmyeloablative allogeneic stem cell transplant|Prior to receiving Campath-1H, patients will be premedicated with Benadryl 50 mg IV or PO, and acetaminophen 650 mg orally. Hydrocortisone 100 mg IV is given on the first day of Campath. The preparative regimen will begin on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. The mixed dosage of chemotherapy may be rounded off to within +/- 5% of the calculated dose, and doses of fludarabine and cyclophosphamide will be based on adjusted ideal body weight. IV hydration and diuretics will be used to maintain adequate urine output during and after administration of cyclophosphamide.
16272071|NCT00849732|Biological|V520|Intentionally Blank
16272072|NCT00849732|Biological|Comparator: V520 (1x10^9 vp/d)|1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26
16272073|NCT00849732|Biological|Comparator: V520 (1x10^10 vp/d)|1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26
16272074|NCT00849732|Biological|Comparator: Placebo|Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26
16272075|NCT00849719|Drug|a combination of PCA MO and continuous infusion of MO|Patients in this arm will recieve a combination of PCA MO (10 ug/kg/bolus, by request) and continuous infusion of MO (10 ug/kg/h), when visual analog scale (VAS) exeeds 5/10 boluses will be self-administered by the patient. Rescue diclofenac 75 mg IM will be allowed once to help prompt start analgesia instead of opioid titration, and 6h later. No hourly dose limit will be set for the protocols.
16272076|NCT00849719|Drug|PCA MO only|When visual analog scale [VAS] exeeds 5/10, and after the PACU drug-blinded attending physician had established that the patient is coherent and cooperative, a PCA system will be connected to the patient's IV line. The physician will start device, and deliver the first bolus. The subsequent drug boluses will be self-administered by the patient. Group 2 will be administered with only boluses of 1.5 mg/bolus of MO, by request. Rescue diclofenac 75 mg IM will be allowed once to help prompt start analgesia instead of opioid titration, and 6h later. No hourly dose limit will be set for the protocols.
16272077|NCT00849706|Other|Study participants will work their regular shifts, and tested after night shifts.No shifts will be added because of the study.|Night shifts in our medical center are working 8 hours from 23:00 to 7:00 the following day for nurses, and working overnight (24h) for doctors.
16272078|NCT00849693|Drug|Placebo|Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)
16272079|NCT00849693|Drug|fluoxetine|20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase)
16272080|NCT00849693|Drug|duloxetine|60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
16272081|NCT00849693|Drug|duloxetine|30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
16272082|NCT00849680|Other|Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine|Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.
16272083|NCT00849680|Biological|Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)|Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)
16272084|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)
16272085|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
16272086|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)
16272087|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)
16272088|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)
16272089|NCT00849680|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)|Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)
16272090|NCT00849680|Biological|Comparator: Placebo to MRKAd5 HIV-1 gag vaccine|Placebo to the MRKAd5 HIV-1 gag vaccine.
16272091|NCT00849667|Drug|MORAb-003 (farletuzumab)|MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
16272092|NCT00849667|Drug|MORAb-003 (farletuzumab)|MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
16272093|NCT00849667|Drug|0.9% Saline|0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
16272094|NCT00849654|Drug|PCI-32765|"In the dose-escalation cohorts, PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5, and 17.5 mg/kg/d dose orally once per day for 28 days followed by a 7-day rest period to determine the MTD. If MTD is not reached, dosing levels may be increased beyond 17.5mg/kg/d by 33% increments.
~In the continuous dosing cohorts, PCI-32765 will be administered in 8.3 mg/kg/day and 560 mg/day (fixed dose) dose orally once per day for 35 days."
16272095|NCT00849615|Drug|Docetaxel|50mg/m2 qd15
16272096|NCT00849615|Drug|5-Fluorouracil|2600mg/m2 qd15
16272101|NCT00849589|Behavioral|Computerized screening and brief physician advice|Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors
16272102|NCT00849589|Behavioral|Computerized SBA with technological extenders|Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice.
16272103|NCT00849576|Drug|Regular Human Insulin|0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
16272104|NCT00849576|Drug|Insulin Lispro|90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
16272105|NCT00849576|Drug|Insulin VIAject™ (75%)|75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
16272106|NCT00849576|Drug|Insulin VIAject™ (90%)|90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
16272107|NCT00849563|Other|Standardized Risk Assessment|patients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling.
16272108|NCT00849550|Drug|capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)|bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
16272109|NCT00849537|Drug|Triamcinolone|Injection of intravitreal Triamcinolone
16272110|NCT00849524|Biological|ISF35|Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
16272111|NCT00849511|Drug|melatonin|Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
16272112|NCT00849485|Drug|Levetiracetam|750 mg Tablet
16272113|NCT00849485|Drug|Keppra®|750 mg Tablet
16272114|NCT00849472|Drug|doxorubicin + cyclophosphamide|4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib.
16272115|NCT00849472|Drug|paclitaxel + pazopanib|4 cycles of paclitaxel + pazopanib
16272116|NCT00849472|Procedure|surgery|neoadjuvant surgery for breast cancer
16272117|NCT00849472|Drug|pazopanib monotherapy|6 months of treatment with pazopanib monotherapy
16272118|NCT00849459|Biological|adenovirus-mediated human interleukin-12|"The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/
~1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC."
16272119|NCT00849446|Device|Activity monitor (SenseWear Pro armband)|Activity monitoring during specific physical activities such as walking at different speeds
16272120|NCT00849381|Biological|GSK580299, GSK Biological's HPV vaccine|All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
16272121|NCT00849368|Drug|Azathioprine / Allopurinol|"Both drugs are applied orally. A pre-specified dose escalation regimen will be chosen.
~Azathioprine: Imurek (R) 50 mg and 25 mg tablets
~Allopurinol: Mephanol (R) 100 mg tablets"
16272122|NCT00849355|Drug|RCOMP-14 + rituximab|"Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0.
~Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d."
16272123|NCT00849342|Drug|insulin detemir|Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
16272124|NCT00849329|Drug|lapatinib|1250mg lapatinib
16272125|NCT00849329|Drug|lapatinib plus esomeprazole|1250mg lapatinib plus esomeprazole 40mg
16272126|NCT00849316|Drug|insulin aspart|Safety and effectiveness data collection in connection with the use of the drug NovoRapid™ in patients with coexisting diabetes and chronic kidney disease in daily clinical practice.
16272127|NCT00849303|Other|gait-oriented rehabilitation|Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts within 10 days since stroke onset.
16272128|NCT00849303|Other|gait-oriented rehabilitation|Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts five weeks after stroke onset.
16272129|NCT00849290|Biological|APC8015F|APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
16272130|NCT00849277|Drug|Lactobacillus casei Shirota|
16272131|NCT00849264|Drug|chemotherapy with endostar|15mg/d×14d
16272132|NCT00849264|Drug|treatment with CBP and 5-FU|CBP 300mg/d×2d，5-FU 1000mg/d×5d
16272133|NCT00849264|Drug|treatment with endostar, CBP and 5-FU|CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
16272134|NCT00849251|Drug|cyclophosphamide|Given IV or PO
16272135|NCT00849251|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16272136|NCT00849251|Drug|bortezomib|Given IV
16272137|NCT00849251|Drug|dexamethasone|Given IV or PO
16272138|NCT00849238|Drug|mycophenolate mofetil|
16272139|NCT00849212|Drug|E2007|The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.
16272140|NCT00849186|Drug|sunitinib malate|oral
16272141|NCT00849186|Procedure|neoadjuvant therapy|IV
16272142|NCT00849186|Procedure|therapeutic conventional surgery|Surgery
16272143|NCT00849160|Drug|darunavir|darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
16272304|NCT00847964|Device|Algisyl-LVR|method of left ventricular restoration in patients with dilated cardiomyopathy
16272144|NCT00849147|Biological|Haploidentical Bone Marrow Transplantation|"The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
~Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2
~Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5
~Total body irradiation (TBI): 200 centigray (cGy) on Day -1
~Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor."
16272145|NCT00849147|Biological|GVHD prophylaxis|"The GVHD prophylaxis regimen will consist of the following:
~Cy: 50 mg/kg IV on Days 3 and 4
~Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL
~Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID
~Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm^3 for 3 consecutive days"
16272146|NCT00849134|Drug|GSK1482160 or placebo|GSK1482160 is a P2X7 receptor antagonist
16272147|NCT00849121|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression
16272148|NCT00849121|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.
16272149|NCT00849108|Drug|BMS747158|"dosages at rest and at stress were not to exceed a total of 14 mCi.
~Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period.
~Cohort 2: Patients to recieve IV bolus injections of BMS747158:
~For the Pharmacologic (Adenosine) Stress:
~Doses at rest were to range between 2.9 and 3.4 mCi.
~Doses under stress were to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi.
~For the Exercise Stress:
~Doses at rest were to range between 1.7 and 2.0 mCi.
~Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
16272150|NCT00849095|Drug|budesonide/formoterol combination (PRN)|budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks
16272151|NCT00849095|Drug|budesonide/formoterol combination|budesonide/formoterol 160/4.5 mcg 1 inhalation bid
16272152|NCT00849095|Drug|placebo|bid inhaled placebo
16272153|NCT00849095|Drug|terbutaline|as needed terbutaline 500 mcg for a period of 52 weeks
16272154|NCT00849082|Drug|cyproterone acetate|
16272155|NCT00849082|Drug|goserelin acetate|
16272156|NCT00849082|Radiation|radiation therapy|
16272157|NCT00849069|Biological|GSK2231395A|3 doses intramuscular injections
16272158|NCT00849069|Biological|TwinrixTM|3 doses intramuscular injections
16272159|NCT00849056|Biological|albiglutide|albiglutide weekly subcutaneous injection
16272160|NCT00849056|Drug|placebo|placebo weekly subcutaneous injection
16272161|NCT00849030|Drug|Anastozole (Arimidex)|1mg, orally, once daily
16272162|NCT00849030|Drug|Tamoxifen (Nolvadex)|20mg, orally, once daily
16272163|NCT00849030|Drug|Anastozole (Arimidex) placebo|1mg, orally, once daily
16272164|NCT00849030|Drug|Tamoxifen (Nolvadex) placebo|20mg, orally, once daily
16272165|NCT00849017|Biological|albiglutide|albiglutide weekly injection
16272166|NCT00849017|Biological|albiglutide uptitration|albiglutide uptitration at week 12
16272167|NCT00849017|Biological|placebo|matching albiglutide placebo weekly injection
16272168|NCT00849004|Other|silicone gel|silicone gel
16272169|NCT00849004|Other|silicone sheet|silicone sheet
16272170|NCT00849004|Other|paper tape|paper tape
16272171|NCT00848991|Drug|Precedex|Subjects randomized to the comparison group will receive a standardized general anesthetic. Anesthesia will be induced with propofol 1.5 ? 2.5 mg/kg, rocuronium 0.6 mg/kg, and sufentanil 0.1 ? 1mcg/kg. Anesthesia will be maintained with an infusion with propofol 25 -200 mcg/kg/min, sufentanil 0.0025 - 0.03 mcg/kg/min, and zemuron as needed. For the Precedex group the drug will be infused at 0.3-0.7 mcg/kg/hr. Blood pressure will be maintained within 10% of baseline prior to opening of the dura, subsequently to be maintained between a systolic of 100 ? 130 mmHg. Hypertension will be managed with standardized amounts of labetalol and nicardipine. Morphine will be titrated as needed to a maximum of 0.05mcg/kg at the conclusion of case. Hemodynamic data and emergence evaluations will be collected in the operating room, pre-induction until the end of anesthesia and discharge from the operating room. There will be no further follow up.
16272172|NCT00848991|Drug|Propofol|evaulation of propofol for emergence from anesthesia
16272173|NCT00848978|Behavioral|8-week aerobic and strength training program|Participants allocated in the intervention group will be enrolled in three weekly non-consecutive training sessions for 8 weeks. Each session will last for about 45-50 min. The exercise program will consist of muscular strength and aerobic exercises. Each session will start and end with a low intensity ~5-7 min warm-up and cool-down period respectively, consisting mainly of stretching exercises involving all major muscle groups.
16272174|NCT00848965|Drug|Fluticasone propionate|Corticosteriod, with anti-inflammatory effects
16272175|NCT00848965|Drug|Placebo|Placebo comparator
16272176|NCT00848952|Other|3 imaging techniques are done|all patients have : MRI, CTscanner, enhanced contrast ultrasound
16272177|NCT00848939|Drug|treprostinil diethanolamine|Cohort 1: Single 1 mg treprostinil diethanolamine sustained release tablet dose
16272178|NCT00848939|Drug|treprostinil diethanolamine|Cohort 2: treprostinil diethanolamine sustained release doses will be escalated up to a target dose of 4 mg BID
16272179|NCT00848926|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by intravenous infusion
16272180|NCT00848913|Other|Rehabilitation with strength training|Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of the fractured limb using ankle weight cuffs, daily during hospital stay.
16272181|NCT00848913|Other|Rehabilitation without strength training|Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
16272182|NCT00848900|Behavioral|Outdoor activity|Adding 1 hour outdoor time into school curricula
16272694|NCT00845104|Genetic|fluorescence in situ hybridization|Correlative studies
16272183|NCT00848887|Biological|Adjuvanted and un-adjuvanted influenza vaccines|16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
16272184|NCT00848874|Behavioral|PVGS|Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.
16272185|NCT00848861|Drug|propofol (sedation for outpatient colonoscopy)|
16272186|NCT00848861|Drug|midazolam plus meperidine (sedation for outpatient colonoscopy)|
16272187|NCT00848848|Biological|Trivalent Influenza Vaccine|1 dose of Trivalent Influenza Vaccine
16272188|NCT00848848|Biological|Trivalent Influenza Vaccine + high A|1 dose of Trivalent Influenza Vaccine with high A content
16272189|NCT00848848|Biological|Trivalent Influenza Vaccine + ¼ dose adjuvant|1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
16272190|NCT00848848|Biological|Trivalent Influenza Vaccine + high A + ¼ dose adjuvant|1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
16272191|NCT00848848|Biological|Trivalent Influenza Vaccine + ½ dose adjuvant|1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
16272192|NCT00848848|Biological|Trivalent Influenza Vaccine + high A + ½ dose adjuvant|1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
16272193|NCT00848848|Biological|Trivalent Influenza Vaccine + adjuvant|1 dose of Trivalent Influenza Vaccine plus adjuvant
16272194|NCT00848848|Biological|Trivalent Influenza Vaccine + high A + adjuvant|1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
16272195|NCT00848848|Biological|Trivalent Influenza Vaccine intradermal dose|1 dose of Trivalent Influenza Vaccine intradermal dose
16272196|NCT00848848|Biological|Trivalent Influenza Vaccine + high A intradermal dose|1 intradermal dose of Trivalent Influenza Vaccine + high A
16272197|NCT00848835|Device|defibrillation lead (ENDOTAK EZ and RELIANCE)|defibrillation lead
16272198|NCT00848809|Procedure|Blood sample|9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
16272199|NCT00848809|Procedure|Blood sample|10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
16272200|NCT00848796|Drug|Heparin Leo and Hepalean|Dosage based on Heparin does response curve obtained from the Medtronic HMS plus
16272201|NCT00848783|Drug|Irinotecan|
16272202|NCT00848783|Drug|Cisplatin|
16272203|NCT00848783|Procedure|Surgery|
16272204|NCT00848783|Drug|Floxuridine|
16272205|NCT00848783|Drug|Capecitabine|
16272206|NCT00848770|Drug|Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)|"Esmolol(2,5g /10ml + SG5% 240ml = 10mg/ml). Start with a bolus of 500mcg/kg in 1 min (ou 0,5mg/kg)and maintain the dose of 50mcg/kg/min (or 0,05mg/kg/min). Increase de infusion in 25mcg/kg/min after each 5 min until the randomized SAP or if the heart beat is lower than 60. The maximum dose is 200ug/kg/min (ou 0,2 mg/kg/min). If the randomized SAP do not reach the goal pressure with the maximum dose of esmolol, start a infusion of sodium nitroprussiate (NPS).
~NPS (50mg + SG5% 250ml= 200mcg/ml). No bolus. Start the infusion with 0,2 mcg/kg/min and maintain 0,5 a 5mcg/kg/min. Increase de dose each 15 min to a maximum of 10mcg/kg/min.
~NOR: (8mg/8ml + SG5% 242ml=32mcg/ml)No bolus. Start 1 to 5 mcg/min to a maximum dose of 20mcg/min."
16272207|NCT00848770|Drug|Esmolol, NPS or NOR|We use one of the three drug to manipulate the systolic arterial pressure
16272208|NCT00848770|Drug|manipulation of SAP|Esmolol or NPS or NOR
16272209|NCT00848757|Behavioral|Intensive Lifestyle Intervention|"Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population."
16272210|NCT00848744|Drug|Formulation A|Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily.
16272211|NCT00848744|Drug|Formulation B|Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.
16272212|NCT00848731|Drug|nitric oxide|nitric oxide gas is delivered by facemask
16272213|NCT00848718|Drug|MK-2206|MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg)
16272214|NCT00848718|Drug|docetaxel|Administered as an IV infusion on Day 1 of each 21-day cycle
16272215|NCT00848718|Drug|erlotinib|Administered daily (QD) PO in each 21-day cycle
16272216|NCT00848718|Drug|carboplatin|Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
16272217|NCT00848718|Drug|paclitaxel|Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
16272218|NCT00848718|Drug|corticosteroid|Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle
16272219|NCT00848705|Behavioral|YourWay Internet Intervention|The intervention is an 11 week program that teaches problem solving of barriers to self-management.
16272220|NCT00848692|Drug|Rituximab|Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
16272221|NCT00848692|Drug|Saline (NaCl 0,9 %) (placebo)|Two infusions of saline (NaCl 0,9 %) given two weeks apart
16272222|NCT00848679|Drug|Epidural lidocaine|Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.
16272223|NCT00848679|Drug|Epidural lidocaine 2%|5 x 5ml boluses of either epidural lidocaine 2% or epidural saline
16272224|NCT00848666|Drug|Topical therapy|One time immersion of the feet in a liquid containing water, alcohol, vinegar, benzoic acid and salicylic acid for a total of 30 minutes.
16272225|NCT00848653|Device|CRT device|market approved CRT device
16272226|NCT00848640|Drug|Sorafenib|400 mg twice daily
16272227|NCT00848627|Other|Specimen and questionnaires only|Specimen and questionnaires only
16272228|NCT00848601|Drug|SGI-1776|Starting dose 100 mg (total daily dose) administer as 50 mg every 12 hours for 14 days of a 21-day cycle, dose escalation in successive cohorts until progression or toxicity develops
16272229|NCT00848575|Device|Flexible Endoscope|
16272230|NCT00848562|Drug|Nicorandil|Oral administration of nicorandil (15 mg/day)
16272303|NCT00847977|Drug|use of balanced crystalloids fluid and macromolecular fluid|Isofundine: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Tetraspan: boli 10 ml/kg on 20 minutes
16274487|NCT00830635|Other|study of socioeconomic and demographic variables|
16272231|NCT00848549|Drug|Zonisamide|Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.
16272232|NCT00848549|Drug|Carbamazepine|Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
16272233|NCT00848536|Drug|Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution|One drop once daily in the evening for 3 months
16272234|NCT00848536|Drug|Travoprost 0.004% (BAK-preserved) Eye Drops, Solution|One drop once daily in the evening for 3 months
16272235|NCT00848523|Drug|Panobinostat|30 mg, three times a week, patients will continue with treatment until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.
16272236|NCT00848510|Biological|EMD 525797|Abituzumab will be administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) to 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) that will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) during initial 6 Weeks, subjects will be allowed to continue treatment at the start of Week 7 at the given dose (250 mg or 500 mg or 1000 mg or 1500 mg) every second week until intolerance to treatment, withdrawal of consent, or the subject is no longer benefiting from treatment in the opinion of the Investigator.
16272237|NCT00848497|Drug|Testim®|Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started.
16272238|NCT00848497|Other|Placebo Testim®|Placebo Testim® 5 g of gel (one tube)
16272239|NCT00848497|Drug|Viagra®|Viagra 25mg was the dose given to the patient which he started.
16272240|NCT00848484|Drug|MK5757|This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days
16272241|NCT00848484|Drug|Comparator: Placebo|This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.
16272242|NCT00848471|Device|Quark RMR|Quark RMR calorimeter (Cosmed)
16272243|NCT00848471|Device|Deltatrac II|Deltatrac II (GE health Care Clinical Systems)
16272244|NCT00848458|Other|Iontophoresis|iontophoresis with 15% azelaic acid gel twice weekly
16272245|NCT00848458|Other|Azelaic acid cream|topical treatment with 20% azelaic acid cream twice daily
16272246|NCT00848445|Device|Guidant Pulsar Max II or Insignia Plus DR|market approved pacemaker. programmed per protocol
16272247|NCT00848445|Device|Atrial pacing preference turned on or off|programing changes in the device
16272248|NCT00848432|Drug|risperidone|Patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months)
16272249|NCT00848419|Drug|Epidural administration of bolus|
16272250|NCT00848393|Drug|Fentanyl (High Dose)|Fentanyl (High Dose) 25 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.
16272251|NCT00848393|Drug|Fentanyl (Low Dose)|Fentanyl (Low Dose) 10 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.
16272252|NCT00848393|Drug|Fentanyl (Low Dose) + Dexmedetomidine|Fentanyl (Low Dose) + Dexmedetomidine. Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
16272253|NCT00848367|Behavioral|Group Psychodynamic Interpersonal Psychotherapy|This intervention will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy (GPIP). GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre. GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy. Patients are given a rationale for the treatment.
16272254|NCT00848354|Biological|Phase 1: Etanercept|Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
16272255|NCT00848354|Drug|Phase 1: Methotrexate|Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
16272256|NCT00848354|Drug|Phase 2: Optional ETN, SSZ, HCQ, MTX|"Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.
~Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.
~Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.
~Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128."
16272257|NCT00848354|Drug|Phase 1: Methotrexate|Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
16272258|NCT00848354|Drug|Phase 1: Conventiaonal DMARD|Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
16272259|NCT00848341|Device|GUIDANT ICD SYSTEM|
16272260|NCT00848328|Biological|Rituximab|Injection for Intravenous Use, 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15.
16272261|NCT00848328|Drug|Lenalidomide|Supplied as 5mg capsules; Dosage: 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
16272262|NCT00848315|Behavioral|Cognitive Behavioral Intervention|The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients.
16272263|NCT00848302|Drug|L-arginine|30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter
16272264|NCT00848289|Behavioral|Interviews|Data collected by personal interview for Epidemiology and Nutrition Questionnaires, with personal and follow-up telephone interviews.
16272265|NCT00848263|Procedure|Volar plate|Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).
16272266|NCT00848263|Procedure|Dorsal nail plate|Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.
16272267|NCT00848250|Drug|Angiotensin Converting Enzyme Inhibitor|Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
16272268|NCT00848250|Other|No ACE Inhibitor|Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
16272269|NCT00848237|Device|Radiofrequency Ablation (HALO Ablation Systems)|Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.
16272270|NCT00848224|Behavioral|systems-based and pharmacist-mediated program|Patients in the SI were seen by a study pharmacists prior to discharge to establish a relationship with the patient, explain the pharmacist's role in the study, provide education about all discharge medications and a medication card listing all medications and their manner of use, and set the framework for the follow-up telephone calls. Patients received pharmacist-delivered adherence counseling telephone contacts that took place at two weeks following discharge, and at months 1, 3, 6, and 9 oriented towards assisting patients to remain adherent to prescribed lipid-lowering and other medications, and also towards ensuring that all patients were either documented to be at the LDL-C goal, or were assisted to reach the goal by facilitating the scheduling of repeat lipid measurement as needed and providing information, guidelines and prompts to the patient's physician or nurse practitioner.
16272271|NCT00848211|Other|Placebo|Subcutaneous injection on Day 0, Day 28, and Day 84
16272272|NCT00848211|Biological|TUTI-16 (0.03mg)|Subcutaneous injection on Day 0, Day 28, and Day 84
16272273|NCT00848211|Biological|TUTI-16 (0.1mg)|Subcutaneous injection on Day 0, Day 28, and Day 84
16272274|NCT00848211|Biological|TUTI-16 (0.6mg)|Subcutaneous injection on Day 0, Day 28, and Day 84
16272275|NCT00848172|Drug|Octanoic Acid|4mg/kg
16272276|NCT00848172|Drug|Placebo|identical capsules
16272277|NCT00848146|Procedure|Endoscopically assisted Laparoscopic Cholecystectomy Surgery|Using endoscopic instruments a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The gallbladder will be removed through the stomach and out of the mouth. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the gastrotomy.
16272278|NCT00848133|Procedure|mini-midvastus surgical approach for total knee arthroplasty|
16272279|NCT00848133|Procedure|mini-subvastus surgical approach for total knee arthroplasty|
16272280|NCT00848120|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 24 weeks
16272281|NCT00848107|Drug|treprostinil diethanolamine|sustained release tablet; BID dosing; up to 16 mg BID
16272282|NCT00848094|Radiation|3DCRT/IMRT|The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.
16272283|NCT00848094|Radiation|3DCRT/IMRT|The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II.
16272284|NCT00848081|Drug|Tadalafil|5 mg taken by mouth once daily for 12 weeks
16272285|NCT00848081|Drug|Placebo|By mouth once daily for 12 weeks
16272286|NCT00848068|Other|FID 114657|artificial tears
16272287|NCT00848068|Other|OPTIVE Lubricant Eye Drops|artificial tears
16272288|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272289|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272290|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272291|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272292|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272293|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272294|NCT00848055|Drug|AbGn168 intravenous infusion|single dose intravenous infusion
16272295|NCT00848055|Drug|AbGn168 subcutaneous injection|single dose subcutaneous injection
16272296|NCT00848042|Device|AuroLase Therapy|Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions
16272297|NCT00848029|Biological|Monovalent inactivated influenza vaccine|Two doses of monovalent inactivated influenza adjuvanted vaccine
16272298|NCT00848016|Drug|R-(-)-gossypol acetic acid|Participants take 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
16272299|NCT00848003|Drug|Bifidobacterium animalis subsp. lactis strain BB-12|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
16272300|NCT00848003|Drug|Placebo|Strawberry flavored yogurt
16272301|NCT00847990|Other|Maternal blood screening test for fetal aneuploidy|One blood draw of 20 to 30 mL
16272302|NCT00847977|Drug|use of a non balced fluid and of a macromolecular fluid|Physiological serum: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Heafusine: boli 10 ml/kg on 20 minutes
16272305|NCT00847951|Procedure|3D Ultrasound Imaging|Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys in pre-mature and/or very low birth weight babies. This is a measure of perfusion and an indication of how well the kidneys are working.
16272306|NCT00847938|Drug|neostigmine|0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
16272307|NCT00847938|Drug|neostigmine|0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
16272308|NCT00847938|Drug|neostigmine|0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
16272309|NCT00847925|Drug|Avotermin (RN1001)|100ul/linear cm of wound. Dosed before surgery and 24h later
16272310|NCT00847912|Drug|5-fluorouracil|"Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
16272311|NCT00847912|Drug|Placebo, vehicle control|"Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
16272312|NCT00847899|Drug|AR9281|AR9281 taken in BID dosing regimen for 28 days
16272313|NCT00847899|Drug|AR9281|AR9281 taken in TID dosing regimen for 28 days
16272314|NCT00847899|Drug|Placebo|Placebo taken in BID dosing regimen for 28 days
16272315|NCT00847899|Drug|Placebo|Placebo taken in TID dosing regimen for 28 days
16272316|NCT00847886|Drug|LX3305|Daily oral intake of LX3305 for 14 days.
16272317|NCT00847886|Drug|LX3305 Placebo|Matching placebo dosing with daily oral intake for 14 days.
16272318|NCT00847886|Drug|Methotrexate|Once weekly stable-dose methotrexate.
16272319|NCT00847873|Behavioral|substance abuse/domestic violence treatment|This intervention is comprised of 16 sessions of cognitive behavioral therapy. 8 sessions are addressing partner violence and 8 sessions are addressing substance abuse
16272320|NCT00847873|Behavioral|Cognitive behavioral therapy addressing substance abuse|This intervention is comprised of 16 sessions of cognitive behavioral therapy addressing substance abuse.
16272321|NCT00847860|Drug|Cilostazol|Cilostazol 100 mg bid for 12 months
16272322|NCT00847860|Drug|Aspirin|Aspirin 100 mg qd for 12 months
16272323|NCT00847847|Procedure|Anconeus Muscle biopsy|Anconeus muscle specimens will be surgically removed. The biopsy will be performed under regional anaesthesia and will require an about 5 cm incision of the skin and muscle fascia from the lateral condyle to over the ridge of the proximal ulna, 3 or 4 cm distal to the tip of the olecranon. A triangular muscle flap will be removed, and then the fascia and skin will be closed with running dissolving suture.
16272324|NCT00847834|Drug|Irbesartan 150mg / Hydrochlorothiazide 12.5mg|Once a day
16272325|NCT00847834|Drug|Irbesartan 150mg|Once a day
16272326|NCT00847821|Drug|Bazedoxifene 10 mg/CE 0.625 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272327|NCT00847821|Drug|Bazedoxifene 20 mg/CE 0.625 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272328|NCT00847821|Drug|Bazedoxifene 40 mg/CE 0.625 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272329|NCT00847821|Drug|Bazedoxifene 10 mg/CE 0.45 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272330|NCT00847821|Drug|Bazedoxifene 20 mg/CE 0.45 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272331|NCT00847821|Drug|Bazedoxifene 40 mg/CE 0.45 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272332|NCT00847821|Drug|Raloxifene 60 mg|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as raloxifene tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16272333|NCT00847821|Drug|Placebo|No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as placebo capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
16274488|NCT00830635|Other|survey administration|
16272334|NCT00847808|Drug|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
16272335|NCT00847795|Drug|Avotermin|Intradermal administration
16272336|NCT00847795|Drug|Placebo|Placebo
16272337|NCT00847782|Procedure|Blood draw|1 day
16272338|NCT00847769|Other|High velocity, low amplitude stretch|This group (n=9) will receive talocrural traction manipulation. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.
16272339|NCT00847769|Other|Slow, mobilization stretch|This group (n=9) will receive talocrural traction mobilization. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating investigator's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.
16272340|NCT00847769|Other|Passive Positioning|This group (n=9) will receive the manual therapy control intervention. This will consist of the same patient and clinician preparation for the mobilization/manipulation techniques. However, a single standardized treating investigator will simply maintain passive ankle positioning for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force characteristic of the intervention received by the other 2 comparison groups.
16272341|NCT00847756|Other|questionnaire|Identification of risk factors
16272342|NCT00847756|Procedure|blood sample|venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
16272343|NCT00847756|Procedure|collection of middle ear fluid|During routine surgery middle ear fluids are collected per patient.
16272344|NCT00847756|Procedure|nasopharyngeal swab|A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
16272345|NCT00847743|Dietary Supplement|Tart Cherry Juice|8 fl.oz. twice per day
16272346|NCT00847730|Device|V.A.C. Negative Pressure Wound Therapy System|This is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an environment that promotes wound healing in chronic and acute wounds
16272347|NCT00847717|Procedure|Selective neck dissection|Level IIb preserving neck dissection
16272348|NCT00847717|Procedure|Conventional Neck dissection|Conventional neck dissection (MRND type III or Supraomohyoid)
16272349|NCT00847704|Device|Assisted movement and enhanced sensation|Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
16272350|NCT00847678|Biological|Efungumab (Mycograb)|
16272351|NCT00847678|Biological|placebo|
16272352|NCT00847678|Biological|Amphotericin B|
16272353|NCT00847678|Biological|5 flucytosine|
16272354|NCT00847665|Other|repositioning|Turning every 4 or 2 hours
16272355|NCT00847639|Drug|lenalidomide|"Lenalidomide maintenance therapy will start within 60 to 90 days after allogeneic HCT at a starting dose of 10mg PO once daily.
~Dose escalation and de-escalation are performed depending on tolerability of lenalidomide.
~The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days)."
16272356|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
16272357|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
16272358|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
16272359|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
16272360|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
16272361|NCT00847626|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
16272362|NCT00847626|Drug|Chlorthalidone|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
16272363|NCT00847626|Drug|Chlorthalidone|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
16272364|NCT00847626|Drug|Azilsartan medoxomil|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
16272365|NCT00847626|Drug|Azilsartan medoxomil|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
16272366|NCT00847626|Drug|Azilsartan medoxomil|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
16272367|NCT00847613|Drug|CP-690,550|Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
16272368|NCT00847613|Drug|CP-690,550|Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
16272369|NCT00847613|Drug|CP-690,550|Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
16272370|NCT00847613|Drug|CP-690,550|Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
16272371|NCT00847613|Drug|Placebo|Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
16272372|NCT00847613|Drug|CP-690,550|Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
16272695|NCT00845091|Behavioral|Exercise|moderate-intensity, low-impact, supervised, aerobic exercise
16272373|NCT00847613|Drug|Placebo|Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
16272374|NCT00847613|Drug|CP-690,550|Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
16272375|NCT00847600|Dietary Supplement|Pregnenolone|50 mg, caps.
16272376|NCT00847600|Dietary Supplement|Placebo|caps
16272377|NCT00847587|Drug|Etonogestrel contraceptive implant|Implant insertion postpartum prior to hospital discharge
16272378|NCT00847587|Drug|Etonogestrel contraceptive implant|Standard insertion at 4-8 weeks postpartum
16272379|NCT00847574|Behavioral|Moderate-fat|35% of calories from fat
16272380|NCT00847574|Behavioral|Lower-fat|20% of calories from fat
16272381|NCT00847561|Behavioral|Family-based CBT|Eight, 1-hour weekly sessions with a trained clinician.
16272382|NCT00847561|Behavioral|Information Monitoring|Packet providing information on strategies for coping with anxiety
16272383|NCT00847548|Behavioral|substance abuse/domestic violence treatment|This intervention is comprised of 16 sessions of cognitive behavioral therapy. 8 sessions are addressing partner violence and 8 sessions are addressing substance abuse.
16272384|NCT00847548|Behavioral|CBT addressing partner violence|This treatment is comprised of 16 sessions of cognitive behavioral therapy addressing partner violence.
16272385|NCT00847535|Biological|autologous muscle cell injection|Injection of autologous muscle cells
16272386|NCT00847522|Drug|Fluorescein|Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
16272387|NCT00847509|Drug|[F-18]FLT|The individual doses of [F-18]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.
16272388|NCT00847496|Device|AWBAT|One-time application of dressing over partial-thickness burns
16272389|NCT00847496|Device|Biobrane|One-time application over partial-thickness burns
16272390|NCT00847483|Drug|latanoprost 0.005% ophthalmic solution|One drop in the evening in the affected eye(s) at 8:00pm
16272391|NCT00847483|Drug|Travoprost 004% sterile ophthalmic solution|One drop in the evening in the affected eye(s) at 8:00pm
16272392|NCT00847483|Drug|Bimatoprost .03% sterile ophthalmic solution|One drop in the evening in the affected eye(s) at 8:00pm
16272393|NCT00847457|Behavioral|Aerobic exercise|Aerobic exercises completed three to four times per week for 20 to 30 minutes per session
16272394|NCT00847457|Behavioral|Stretching|Easy to moderate stretching routines completed three times per week, with a new set of routines given each week
16272395|NCT00847444|Drug|Drug-based intervention|Randomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22
16272396|NCT00847444|Behavioral|Lifestyle-based Intervention|"All Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows:
~Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention."
16272397|NCT00847418|Drug|esketamine hydrochloride|
16272398|NCT00847405|Drug|Sumatriptan Succinate|100 mg Tablets
16272399|NCT00847405|Drug|Imitrex®|100 mg Tablet
16272400|NCT00847392|Procedure|Ultrasound prior to bladder catheterization|Bedside ultrasound to estimated volume of urine in bladder
16272401|NCT00847379|Drug|Ataluren|Ataluren oral powder for suspension will be administered as per dose and schedule specified in the arm.
16272402|NCT00847366|Drug|Perifosine|All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
16272403|NCT00847366|Drug|Trastuzumab|Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.
16272404|NCT00847366|Drug|Tamoxifen|Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .
16272405|NCT00847340|Procedure|Biopsy Excisional|Biopsied from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using apply of Monsel solution. Biopsied sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture.
16272406|NCT00847327|Behavioral|Parental Support|The intervention utilizes cognitive behavioral strategies. Session 1 uses relaxation and cognitive reframing and explores parents' responses to the challenges of parenting a child with diabetes. Session 2 focuses on the emotional impact of having a child with diabetes and utilizes problem solving techniques. Session 3 focuses on child behavior and strategies for effective parenting. To facilitate support and community, Session 4 is a group session via conference call to discuss issues related to social support. Session 5 focuses on the impact diabetes has on the family and parents are taught cognitive reframing to help with managing diabetes. Parents are invited to participate in an Internet bulletin board moderated by trial personnel.
16272407|NCT00847327|Behavioral|Diabetes Education|The education comparison group also participates in 5 sessions across 9 weeks. This group provides educational and resource support that is specific to managing diabetes in young children. Education topics include blood glucose monitoring, nutrition, and physical activity. Print materials are provided to participants and intervention sessions focus on talking points raised in these reading materials.
16272408|NCT00847314|Drug|Testosterone Undeconate (Nebido-R, BAY86-5037)|Male patients > 35yrs in medical practices fulfilling all criteria for documentation.
16272409|NCT00847288|Other|Monthly Review Arm|Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
16272410|NCT00847288|Other|Quarterly Review Arm|Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
16272411|NCT00847275|Other|Exclusive nephrology follow-up|"250 patients will be included and randomized in the exclusive nephrology follow-up arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring."
16272412|NCT00847275|Other|Geriatric follow-up|"250 patients will be included and randomized in geriatric follow-up arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. Patients randomized in the geriatric follow-up arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status."
16272413|NCT00847262|Drug|Temisartan|Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day
16272414|NCT00847262|Drug|Amlodipine|Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day
16272415|NCT00847249|Drug|AZD9164|Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
16272416|NCT00847249|Drug|Placebo|Each subject will receive a single-dose.
16272417|NCT00847223|Drug|ZARNESTRA (Tipifarnib)|
16272418|NCT00847210|Drug|Dexlansoprazole MR|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
16272419|NCT00847210|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
16272420|NCT00847197|Drug|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
16272421|NCT00847197|Drug|Comparator: Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
16272422|NCT00847184|Device|Intubation|Intubation using the standard MacIntosh blade
16272423|NCT00847184|Device|Airtraq|Intubation with the use of the Airtraq technique
16272424|NCT00847171|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|"Day 0 : Allogeneic GM-CSF-secreting Breast Cancer Vaccine administered as:
~12 intradermal injections of a divided total dose of 5 x108 cells."
16272425|NCT00847171|Biological|trastuzumab|"Patient HAS received prior Trastuzumab within the last two weeks, give Trastuzumab 2 mg/kg weekly on Day -1 for 5 weeks.
~Patient has NOT received Trastuzumab within the last two weeks, give On Cycle 1, Day -1 ONLY, Loading dose 4 mg/kg"
16272426|NCT00847171|Drug|cyclophosphamide|Cyclophosphamide 200mg/m2 IV in NS 100ml over 30 minutes on Day -1 ONLY. Note: there are no dose modifications for Cyclophosphamide.
16272427|NCT00847171|Other|flow cytometry|Samples will be analyzed by flow cytometry using Cell Quest software
16272428|NCT00847171|Other|immunoenzyme technique|
16272429|NCT00847171|Other|immunohistochemistry staining method|Measuring Immune Priming In Vivo By Vaccine Site Biopsies
16272430|NCT00847171|Other|laboratory biomarker analysis|
16272431|NCT00847171|Other|pharmacological study|
16272432|NCT00847171|Procedure|biopsy|skin biopsy to be performed on day 3 and day 7 for cycle 1 and 3 only
16272433|NCT00847158|Procedure|phacoemulsification alone|phacoemulsification alone
16272434|NCT00847158|Device|iStent Trabecular Micro-Bypass Stent|phacoemulsification and implantation of the iStent® trabecular micro-bypass stent
16272435|NCT00847145|Biological|1a - rMenB+OMV NZ and routine vaccines|One dose of rMenB vaccine and routine vaccine at study month 12.
16272436|NCT00847145|Biological|1b - rMenB+OMV NZ and routine vaccines|One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
16272437|NCT00847145|Biological|2a - Routine and rMenB+OMV NZ vaccines|One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
16272438|NCT00847145|Biological|2b - rMenB+OMV NZ and routine vaccines|Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
16272439|NCT00847145|Biological|3a - rMenB+OMV NZ and routine vaccines|One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
16272440|NCT00847145|Biological|3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations|One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
16272441|NCT00847145|Biological|4a- rMenB+OMV NZ and routine vaccines|One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
16272442|NCT00847145|Biological|4b - rMenB+OMV NZ and routine vaccines|One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
16272443|NCT00847132|Behavioral|Collaborative Care Treatment|Depression education, treatment recommendations, coordination of care
16272444|NCT00847132|Behavioral|Usual Care Treatment|Treatment as usual, providers are notified of diagnoses
16272445|NCT00847119|Biological|Bevacizumab|Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
16272446|NCT00847119|Drug|capecitabine (Xeloda)|Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
16272447|NCT00847119|Radiation|Rectal Radiotherapy|Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
16272448|NCT00847106|Drug|Daclizumab|
16272449|NCT00847106|Biological|Dendritic cells|
16272450|NCT00847093|Drug|LMX4|One inch every six hours
16272451|NCT00847093|Drug|LMX4 Placebo|One inch every six hours
16272452|NCT00847080|Drug|Sitagliptin phosphate|Sitagliptin phosphate 100 mg per day per 2 weeks
16272453|NCT00847080|Drug|Placebo|Placebo 1 tablet per day per 2 weeks
16272454|NCT00847067|Procedure|Paravertebral block|3ml 1% Ropivacaine at each level T1 - T5
16272455|NCT00847067|Procedure|Sham injections|Sham injections with Normal Saline
16272456|NCT00847054|Drug|MORAb-004 (monoclonal antibody to TEM1)|Intravenous administration
16272457|NCT00847028|Other|glucose 10%|2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
16272458|NCT00847028|Other|20% glucose|2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
16272459|NCT00847028|Other|glucose 30%|2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
16272460|NCT00847028|Other|sterile water|2 minutes prior to the venipuncture, sterile water was administered orally
16272461|NCT00847015|Drug|Sunitinib|Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.
16272462|NCT00847015|Drug|Gemcitabine|Gemcitabine 1,000 mg/m^2
16272463|NCT00847015|Drug|cisplatin|cisplatin 35 mg/m^2 will be administered intravenously on days 1 and 8.
16272464|NCT00847002|Device|Standard Wound Care|
16272465|NCT00847002|Device|Flexitouch System with Standard Wound Care|
16272466|NCT00846989|Drug|RKI983A|RKI983 0.05 % twice daily
16272467|NCT00846989|Drug|RKI983A|RKI983 0.1 % twice daily
16272468|NCT00846989|Drug|Latanoprost|Latanoprost 0.005 % once a day
16272469|NCT00846976|Drug|Bicalutamide|200mg daily
16272470|NCT00846963|Drug|Ursodiol|"Ursodiol is given by mouth, three times a day from second value of elevated conjugated bilirubin (>33mmol/L) to the resolution of cholestasis (conjugated bilirubin <34mmol/L) If Nil per os, 3,3mg/kg/dose is given. If Nil per os is required (e.g. pre-surgery, or necrotizing enterocolitis), none is given.
~If enteral feeding is under 100mL/kg/day, 6,7 mg/kg/day is given. If enteral feeding exceeds 100mL/kg/day, 10 mg/kg/day is given."
16272471|NCT00846963|Drug|placebo|Placebo given in the same amount that ursodiol would be given, depending on enteral feeding and weight. It is also given three times a day, until cholestasis resolution.
16272472|NCT00846950|Drug|dexchlorpheniramine, lorazepam|
16272473|NCT00846937|Dietary Supplement|Plant stanolester and fatty acid|Plant stanol ester 2gr/day and fatty acid in a beverage compared to plant stanol ester 2gr /day and placebo
16272474|NCT00846924|Device|a 30-day ambulatory cardiac event monitor|Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.
16272475|NCT00846924|Device|24-hour Holter|Repeat standard 24-hour Holter Monitor
16272476|NCT00846911|Drug|Moxifloxacin (Avelox, BAY12-8039)|Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin
16272477|NCT00846898|Dietary Supplement|cinnamon 2g per day for 12 weeks|Subjects in intervention group will receive cinnamon capsules for 12 weeks period. The 2 g dose of cinnamon will be spread over the day as 500 mg (1 capsule) after breakfast, 1000 mg (2 capsules) after lunch and 500 mg (1 capsule) after dinner. The subjects will be instructed to take the capsules immediately after the meals.
16272478|NCT00846885|Drug|Sumatriptan Succinate|100 mg Tablet
16272479|NCT00846885|Drug|Imitrex®|100 mg Tablet
16272480|NCT00846872|Drug|GHRP-3 low dose|0.1 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
16272481|NCT00846872|Drug|GHRP-3 high dose|0.5 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
16272482|NCT00846872|Drug|Saline|5% mannitol will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
16272483|NCT00846859|Drug|varenicline (Champix/Chantix)|14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).
16272484|NCT00846859|Drug|placebo for varenicline|14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
16272485|NCT00846846|Device|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
16272486|NCT00846833|Biological|Haploidentical NK cell|"Collection of PBMCs by leukapheresis
~CD3+ depletion of apheresis product using CliniMACS®"
16272487|NCT00846781|Drug|Denufosol tetrasodium Inhalation Solution|60 mg by oral inhalation three times daily
16272488|NCT00846768|Drug|BI 1744 CL|
16272489|NCT00846755|Drug|Levothyroxine, Propylthiouracile|Drugs were titrated to render euthyroid pregnant patients with thyroid disease
16272490|NCT00846742|Drug|Stanford V Chemotherapy|The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone
16272491|NCT00846742|Radiation|Radiation Therapy|Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.
16272492|NCT00846729|Procedure|CT angiogram of the remaining kidney.|
16272493|NCT00846729|Procedure|Kidney Function study using Iothalamate & PAH as clearance markers|
16272494|NCT00846716|Drug|Pioglitazone add on to SU or biguanide|As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.
16272495|NCT00846716|Drug|SU or Biguanide|As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
16272496|NCT00846703|Drug|6-mercaptopurine, Methotrexate|"6-mercaptopurine p.o. qd
~Methotrexate p.o. qw"
16272497|NCT00846703|Drug|6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone|"(1)6-mercaptopurine p.o. qd x 7w Methotrexate p.o. qd x 7w
~(2)Vincristine qw x 1w Dexamethasone p.o. qd x 7d
~Go to (1) and (2)"
16272498|NCT00846690|Drug|benzocaine|20% benzocaine., topical placement onto site, minimal amount, for 1 minute
16272499|NCT00846690|Drug|TAC alternate gel|use 1 pump, place topically onto site, leave for 1-3 minutes
16272500|NCT00846677|Dietary Supplement|Vitamin D, cholecalciferol|Oral Quick Dissolve Strip, 400 IU once per day for 21 days
16272501|NCT00846677|Dietary Supplement|Vitamin D, cholecalciferol|Oral Syrup, 400IU per day for 21 days
16272502|NCT00846664|Procedure|Logan Short Arc Banding|Group 1 wil perform short arc banding twice a week for four weeks and have diagnostic ultrasound of multifidus measured before and after intervention
16272503|NCT00846651|Other|Colloid administration|The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
16274489|NCT00830635|Procedure|psychosocial assessment and care|
16272504|NCT00846651|Other|Crystalloid administration|The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
16272505|NCT00846651|Drug|phenylephrine infusion|A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
16272506|NCT00846638|Behavioral|Brief Intervention|Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up
16272507|NCT00846638|Behavioral|Diagnostic assessment|Single session diagnostic assessment with 12 month followup
16272508|NCT00846625|Drug|triamcinolone|Intravitreal injection (4 mg/0.1 ml)
16272509|NCT00846625|Drug|ranibizumab|Intravitreal injection, 0.5 mg
16272510|NCT00846612|Drug|Doxil|1 cycle: 3 weeks; 30 mg/m^2, IV, every cycle
16272511|NCT00846612|Drug|Bevacizumab (Avastin)|1 cycle: every 3 weeks; 15 mg/kg, IV, beginning on cycle 2 and every cycle 20-24 hours following Doxil administration
16272512|NCT00846599|Other|Omega-3 study meal|Participant will eat a study meal high in omega-3 fatty acids.
16272513|NCT00846599|Other|Saturated fat study meal|Participant will eat a study meal high in saturated fat.
16272514|NCT00846586|Drug|Indacaterol 150 μg|Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16272515|NCT00846586|Drug|Tiotropium 18 μg|Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
16272516|NCT00846586|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16272517|NCT00846573|Drug|Hyperpolarized Helium-3|Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
16272518|NCT00846547|Drug|Arbaclofen|variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
16272519|NCT00846521|Drug|Acarbose|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
16272520|NCT00846508|Drug|Cisplatin|Cisplatin is available commercially as a sterile lyophilized white power in single-dose amber vials containing 10 mg or 50 mg of cisplatin for administration by IV infusion. Every effort should be made to obtain and record the lot numbers of the batches of cisplatin used. Unopened vials of cisplatin are stable for the shelf-life indicated on the package when stored in accordance with the manufacturers' instructions.
16272521|NCT00846495|Drug|topiramate|topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks
16272522|NCT00846495|Drug|frovatriptan|frovatriptan 5mg tab during premonitory phase of migraine
16272523|NCT00846482|Drug|Oxaliplatin|Oxaliplatin will be administered once every 2 or 3 weeks
16272524|NCT00846469|Procedure|CCTA (coronary computed tomography angiography)|A CCTA (coronary computed tomography angiography) scan is a CT scan of the blood vessels of the heart. This CCTA (Coronary Computed Tomography Angiography)will be performed and a contrast medication will be injected through an IV line to help make the CT pictures more clear. Medication may or may not be given to control your heart rate during the scan. After the scan is completed it will be read. Your emergency room physician will use the CT results to determine your treatment.
16272525|NCT00846469|Other|Control section|Normal emergency room treatment for symptoms of chest pain.
16272526|NCT00846456|Biological|Dendritic cell vaccine with mRNA from tumor stem cells|Intradermal injection of transfected dendritic cells
16272527|NCT00846443|Other|Concurrent Pemetrexed, Cisplatin and Radiotherapy|pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
16272528|NCT00846443|Other|Concurrent Pemetrexed, Cisplatin and Radiotherapy|pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
16272529|NCT00846443|Other|Concurrent Pemetrexed, Cisplatin and Radiotherapy|pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
16272530|NCT00846443|Other|Concurrent Pemetrexed, Cisplatin and Radiotherapy|pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions
16272531|NCT00846430|Drug|Peg-Interferon alpha-2b|age and weight dependant
16272532|NCT00846430|Drug|Celecoxib (Celebrex)|age and weight dependant
16272533|NCT00846430|Drug|Temozolomide (temodar)|age and weight dependant
16272534|NCT00846430|Drug|Vincristine Sulfate (Oncovin)|age and weight dependant
16272535|NCT00846391|Drug|MK8245 5 mg (twice a day) b.i.d.|"All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
~Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening."
16272536|NCT00846391|Drug|MK8245 50 mg b.i.d.|"All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
~Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening."
16272537|NCT00846391|Drug|Placebo|"All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
~Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening."
16272538|NCT00846378|Procedure|Post conditioning|after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
16272539|NCT00846378|Procedure|Usual Care for STEMI|Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
16272696|NCT00845091|Behavioral|Heart Healthy Education|Educational topics related to heart health (e.g., nutrition, smoking, sleep)
16272697|NCT00845065|Drug|Boceprevir|800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
16272540|NCT00846365|Drug|Azilsartan medoxomil and chlorthalidone|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
16272541|NCT00846365|Drug|Azilsartan medoxomil and chlorthalidone|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.
~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
16272542|NCT00846365|Drug|Olmesartan medoxomil-hydrochlorothiazide|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.
~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
16272543|NCT00846352|Procedure|Variation in the time for performing bronchoscopy|The study will compare outcomes amongst patients assigned to receive early bronchoscopy (within 36 hours of enrollment)versus those in whom bronchoscopy is delayed (5 days after enrollment).
16272544|NCT00846339|Drug|Bupropion|bupropion
16272545|NCT00846326|Drug|oxymetazoline-fluticasone propionate|Oxymetazoline 0.05% w/v Fluticasone propionate 0.05% w/w 2 squirts in each nostril twice daily
16272546|NCT00846326|Drug|Oxymetazoline|oxymetazoline 0.05% w/v and placebo nasal spray 2 squirts in each nostril twice daily
16272547|NCT00846313|Other|Individual dietary counseling.|Dietary advice based on individual requirement and symptom burden. Dietary intervention may be dietary advice, energy rich foods and drinks, oral nutritional supplements, appetite stimulation with Megestrol Acetate, enteral or parenteral nutrition.
16272548|NCT00846300|Behavioral|Physician counseling for health behavior change|Physician counseling for health behavior change, compared to a no-counseling comparison group
16272549|NCT00846287|Drug|Hyperpolarized Helium-3|Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the intervention (drug or placebo) will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.
16272550|NCT00846287|Drug|Placebo|Subject will inhale a placebo (nebulized saline) with no drug.
16272551|NCT00846287|Drug|Aformoterol|Subjects will receive the drug arformoterol prior to scanning
16272552|NCT00846274|Biological|SK Antithrombin III|
16272553|NCT00846261|Device|Use it to treatment bone nonunion (Ilzarov)|Detect the variation of limb lengthening
16272554|NCT00846248|Dietary Supplement|Chromium|We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.
16272555|NCT00846248|Dietary Supplement|placebo|We will enroll non-obese, non-diabetic subjects with insulin resistance in a 16 week treatment program with 500 μg of chromium picolinate twice daily. Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment. Subjects will be compared to a placebo-treated group.
16272556|NCT00846235|Other|Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%|moisturising cream twice daily three weeks
16272557|NCT00846222|Procedure|Hypothermia|Mild therapeutic hypothermia, 33-34 celsius, for 12 hours
16272558|NCT00846209|Other|Enhanced drug labeling|use of clear concise text and icons on drug warning labels
16272559|NCT00846196|Drug|risedronate DR (Phase III clinical supply)|Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
16272560|NCT00846196|Drug|risedronate 35 mg DR (Commercial Tablet)|Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
16272561|NCT00846183|Procedure|local injury|In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed
16272562|NCT00846170|Drug|co-biotic|give probiotic 2 t/day
16272563|NCT00846170|Drug|placebo 2T/day|cross over of patients from study arm to placebo arm
16272564|NCT00846157|Biological|NKM injection|NKCell about 100mg IV for 6times in each chemotherapy period.
16272565|NCT00846144|Dietary Supplement|copper sulfate|copper sulfate 3mg/d for a period of 6 months
16272566|NCT00846131|Drug|Sorafenib|Randomized to Y-90 ± Sorafenib
16272567|NCT00846131|Drug|Yttrium-90 (Y-90)|Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion
16272568|NCT00846118|Drug|Pitavastatin|1-4mg/day
16272569|NCT00846105|Other|Rapid MRSA PCR test for screening carriers|In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.
16272570|NCT00846092|Device|Warp 10 LED Device|Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months
16272571|NCT00846092|Device|Near-infrared light (NIR)|"Subjects will be exposed to light emitted from LED's at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye.
~Treatments involve application of the LED-generated light for 80 seconds, twice daily."
16272572|NCT00846079|Device|Regadenoson (Lexiscan) [muti-detector computed tomography]|Regadenason, typical dosing
16272573|NCT00846066|Other|Hands on training|Hands on training by a pediatric dentist on preventive oral health
16272574|NCT00846066|Other|Web based training|Web based training alone
16272698|NCT00845065|Other|Placebo|800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks
16272575|NCT00846053|Diagnostic Test|FDG-PET|All subjects underwent FDG-PET and low-dose volumetric CT imaging. After completing a transmission scan, [18F]FDG was injected intravenously at the start of dynamic scan acquisition. Regions of interest were drawn over multiple tomographic slices to determine average whole-lung and regional lung tissue [18F] FDG uptake. Patlak graphical analysis was used to determine the rate of [18F]FDG uptake from the blood input function and lung tissue activity curves, measured as the influx constant Ki (slope of the linear regression from the Patlak plot). Corrected Ki (i.e., Ki divided by the initial volume of distribution). Lung density was calculated from the attenuation image by standard methods.
16272576|NCT00846040|Other|Reduced fat diet|RF (selective reduction of 85% of baseline fat calories per day)
16272577|NCT00846040|Other|Reduced carbohydrate diet|RC (selective reduction of 60% of baseline carbohydrate calories per day)
16272578|NCT00846040|Drug|Drug: f-18 fallypride|Dopamine D2 receptor availability is measured by positron emission tomography (PET) using the positron emitting compound [18F] fallypride which binds competitively with dopamine to the D2 receptor.
16272579|NCT00846040|Device|fMRI|Functional MRI (fMRI) will be used to measure the effects of diet and weight loss on regional brain activity
16272580|NCT00846040|Device|PET|Positron emission tomography (PET) will be used to assess whether To assess whether brain activity and reward pathways are altered
16272581|NCT00846027|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in glass vials.
16272582|NCT00846027|Drug|Paclitaxel|Paclitaxel was supplied as a sterile liquid in glass vials.
16272583|NCT00846027|Drug|Gemcitabine|Gemcitabine was supplied as a sterile liquid in glass vials.
16272584|NCT00846014|Drug|Helium-3|Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.
16272585|NCT00846001|Procedure|Coronary artery bypass grafting|Standard coronary surgry according guidelines
16272586|NCT00846001|Device|Epicardial implantation of cardiac resynchronization therapy device|During the cardiac surgery, the CABG+CRT arm patients will be implanted with epicardial leads to the right atrium, right and left ventricles. Left ventricle leads will be fixed to the posterolateral wall provided that there is no scar or fat tissue (behind and 2-3 cm apical than obtuse marginal artery). Right atrial and right ventricular leads will be fixed in a traditional way. Then the leads will be guided into a preformed pocket (left subclavian region) and connected with the CRT device.
16272587|NCT00845988|Drug|aripiprazole|dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
16272588|NCT00845975|Device|Erchonia Hearing Lasers #1 & #2|"Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.
~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
16272589|NCT00845975|Device|Placebo Lasers|The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.
16272590|NCT00845962|Drug|chloroprocaine|spinal administration of chloroprocaine 2%, 40 mg (2 mL)
16272591|NCT00845962|Drug|bupivacaine|spinal administration of bupivacaine 0,75% 7,5 mg (1 mL)
16272592|NCT00845936|Drug|Metformin|Metformin 850 mg bid
16272593|NCT00845923|Drug|Civamide Patch|Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.
16272594|NCT00845910|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of every 3 week cycle
16272595|NCT00845910|Drug|capecitabine [Xeloda]|900mg/m2 po on days 1-14 of every 3 week cycle
16272596|NCT00845910|Drug|docetaxel|60mg/m2 iv on day 1 of every 3 week cycle
16272597|NCT00845897|Drug|Botulinum Toxin|200 units of botulinum toxin, and 300 units of botulinum toxin. Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus
16272598|NCT00845897|Drug|Saline|Placebo (saline) (3cc). Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus
16272599|NCT00845884|Drug|Docetaxel, Cisplatin, Capecitabine, Bevacizumab|"Docetaxel 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days.
~Cisplatin 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days.
~Capecitabine 1,600 mg/m2/d PO, divided into two daily doses, on Days 1-14, Q:21 days.
~Bevacizumab 7.5 mg/kg IV, on Day 1, Q:21 days."
16272600|NCT00845871|Drug|deferasirox:|Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
16272601|NCT00845858|Drug|metoclopramide|30 minutes before meals and at bedtime for 4 weeks
16272602|NCT00845858|Drug|Placebo|30 minutes before meals and at bedtime
16272603|NCT00845845|Drug|Omega-3-acid ethyl esters (Lovaza)|4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.
16272604|NCT00845845|Drug|Placebo|Daily placebo with dietary counseling for 24 weeks.
16272605|NCT00845832|Drug|Placebo|iv on days 1 and 15 (Parts 1 and 2)
16272606|NCT00845832|Drug|rituximab [MabThera/Rituxan]|0.5g iv on days 1 and 15 (Parts 1 and 2)
16272607|NCT00845832|Drug|tocilizumab [RoActemra/Actemra]|2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2
16272608|NCT00845819|Drug|rhEGF + povidone iodine, chlorhexidine, & nystatin|"Topical application of 50 µg/mL rhEGF solution twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%) & nystatin (5,000IU/mL) three times a day.
~Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC>1000/µL for 3 days) or disappearance of oral mucositis.
~For each application of rhEGF, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva."
16272699|NCT00845065|Biological|Peginterferon alfa-2a|Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks
16272700|NCT00845065|Drug|Ribavirin|"Ribavirin 200-mg capsules, weight-based dosing
~<75 kg, 1000 mg/day orally (PO), divided twice daily (BID)
~>=75 kg, 1200 mg/day PO, divided BID
~for 48 weeks"
16274490|NCT00830635|Procedure|quality-of-life assessment|
16272609|NCT00845819|Drug|Placebo + povidone iodine, chlorhexidine, & nystatin|"Topical application of placebo drug twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%), and nystatin (5,000IU/mL) three times a day.
~Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC>1000/µL for 3 days) or disappearance of oral mucositis.
~For each application of placebo drug, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva."
16272610|NCT00845806|Other|MRI|All subjects will be asked to lay in an MRI for about an hour while reading Arabic diacritic characters
16272611|NCT00845793|Behavioral|Nutritional guidance|The guidance will be performed using the food tray during the hospitalization and will consist of meeting the nutritionist and receiving brochures along with the meal tray focusing on constituents and elements of the diet. The served meals will consist of elements recommended for patients with T2DM (such as whole grains, low fat dairy products and canola oil).
16272612|NCT00845780|Drug|withdrawal or continuation of amiodarone therapy|withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy
16272613|NCT00845767|Procedure|Forearm Vascular Study|"Forearm venous occlusion plethysmography during intraarterial infusion of L-NMMA (2-8 µmol/min) followed by co-infusion of sodium nitroprusside (90-900 ng/min) as a nitric oxide clamp. Forearm blood flow then measured during the clamp in response to infused vasodilators acetylcholine (5-20 mg/min), bradykinin (100-1000 pmol/min), verapamil (10-100 µg/min) and sodium nitroprusside (2-8 µg/min)."
16272614|NCT00845754|Drug|ketorolac|15mg IV every6 hours for 4doses
16272615|NCT00845754|Drug|saline|15mg IV every 6hrs for 4 doses
16272616|NCT00845728|Drug|Indacaterol 150 µg|Indacaterol 150 µg o.d. delivered via SDDPI
16272617|NCT00845728|Drug|Tiotropium|Tiotropium 18 µg o.d. delivered via handihaler®
16272618|NCT00845715|Other|Early motion|Early referral to physical therapy for range of motion (2 days post)
16272619|NCT00845715|Other|Standard motion|Standard referral to physical therapy for range of motion (4 weeks post)
16272620|NCT00845702|Drug|Gadoterate meglumine (Dotarem)|Each subject will receive one injection of Dotarem 0.2 ml/kg
16272621|NCT00845702|Other|Time of Flight Magnetic Resonance Angiography|Each subject will undergo a TOF MRA
16272622|NCT00845689|Drug|placebo|NaCl 0,9 %
16272623|NCT00845689|Drug|adenosine|intravenous infusion of adenosine 0, 2 %
16272624|NCT00845689|Drug|adenosine|intravenous infusion of adenosine 0,2 %
16272625|NCT00845689|Procedure|Liver resection|Liver resection with Pringle maneuver
16272626|NCT00845676|Drug|Pegylated interferon alfa-2a + Ribavirin|Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
16272627|NCT00845663|Drug|Certolizumab pegol|Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
16272628|NCT00845663|Drug|Certolizumab pegol|Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
16272629|NCT00845650|Biological|AIGIV 3.5 mg/kg|AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
16272630|NCT00845650|Biological|Gamunex 90 mg/kg|Gamunex 90 mg/kg total IgG as a single intravenous infusion.
16272631|NCT00845650|Biological|AIGIV 7.0 mg/kg|AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
16272632|NCT00845650|Biological|Gamunex 180 mg/kg|Gamunex 180 mg/kg total IgG as a single intravenous infusion.
16272633|NCT00845650|Biological|AIGIV 14.0 mg/kg|AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
16272634|NCT00845650|Biological|Gamunex 360 mg/kg|Gamunex 360 mg/kg total IgG as a single intravenous infusion.
16272635|NCT00845637|Drug|Eggplant extract|Dry eggplant extract in two 450mg capsules, twice a day (before the main meals) for fourteen days.
16272636|NCT00845637|Drug|Placebo|Placebo in two 450mg capsules, twice a day (before the main meals) for fourteen days.
16272637|NCT00845611|Biological|peptide vaccine|peptides emulsified with Montanide ISA51
16272638|NCT00845598|Drug|Azelastine , fluticasone|"Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination
~1 squirt in each nostril twice daily"
16272639|NCT00845598|Drug|Fluticasone propionate|Fluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt)
16272640|NCT00845585|Device|Below Knee Arterial Reconstruction|Patency, Reinterventions, Amputations, mortality
16272641|NCT00845585|Device|Below Knee Arterial Reconstruction|Patency, Reinterventions, Amputations, mortality
16272642|NCT00845572|Behavioral|Consta Club|Biweekly group for patients receiving Risperdal Consta injections. Each 45 minute group includes socialization time, goal-setting, illness and medication education, and refreshments.
16272643|NCT00845559|Drug|Exenatide|Subjects randomized to treatment will receive a four month supply of exenatide and will be taught how to administer subcutaneous injections with their exenatide pen and instructed on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month supply.
16272644|NCT00845546|Drug|10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets|
16272645|NCT00845533|Drug|Dihydroartemisinin-Piperaquine|
16272646|NCT00845520|Device|Lens implantation +1.00 D postop target|Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
16272647|NCT00845520|Device|Lens implantation -1.00 D postop target|Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
16272648|NCT00845520|Device|Lens implantation 0.00 D postop target|Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
16272649|NCT00845507|Drug|Exenatide|The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
16272650|NCT00845507|Drug|Placebo|Placebo: Sterile solution in equivalent doses as Exenatide
16272701|NCT00845039|Biological|Cetuximab|Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance
16272702|NCT00845039|Drug|Irinotecan|180 mg/m² every 14 days until disease progression or participant intolerance
16274544|NCT00830323|Drug|oseltamivir|oseltamivir (75mg bd for 5 days, oral)
16272651|NCT00845494|Behavioral|cognitive behavioral intervention|The intervention will consist of an hour of cognitive behavioral education. The first 15 minutes spent discussing cases examples of medication errors. The next 15 minutes will include identifying old rules or assumptions nurses have about medication history obtainment. The next 15 minutes will be utilized reviewing a medication tool to be used, and the last 15 minutes will be discussing techniques to help nurse obtain information from elderly patients.
16272652|NCT00845481|Drug|Daivobet® ointment|Once daily application 6 days a week for 3 weeks
16272653|NCT00845481|Drug|Betnovat® ointment|Once daily application 6 days a week for 3 weeks
16272654|NCT00845481|Drug|Diprosalic ointment|Once daily application 6 days a week for 3 weeks
16272655|NCT00845481|Drug|Dermovat ointment|Once daily application 6 days a week for 3 weeks
16272656|NCT00845481|Drug|Elocon ointment|Once daily application 6 days a week for 3 weeks
16272657|NCT00845481|Drug|Daivobet® ointment vehicle|Once daily application 6 days a week for 3 weeks
16272658|NCT00845442|Device|pacemaker|Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode
16272659|NCT00845429|Biological|Influenza virus vaccine - cell based (2007-2008 Formulation)|0.5 mL, Intramuscular
16272660|NCT00845429|Biological|Influenza virus vaccine - cell-based (2007-2008 Formulation)|1.0 mL, Intramuscular
16272661|NCT00845429|Biological|Influenza virus vaccine (2007-2008 Formulation)|0.5 mL, Intramuscular
16272662|NCT00845377|Behavioral|Comprehensive psychosocial support for depressed elderly|The model includes a psychiatric nurse as a care manager, a multiprofessional team with a physiotherapist, psychologist and psychiatrist. Each participant receives individually tailored services such as therapeutic groups, conversation groups, physical exercise, music therapy, art therapy and nutritional counseling
16272663|NCT00845364|Drug|Perhexiline|Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
16272664|NCT00845364|Drug|Placebo marked PEXSIG|Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
16272665|NCT00845351|Drug|Bexarotene|bexarotene at 300 mg/m2/day
16272666|NCT00845338|Drug|Darifenacin (BAY79-4998)|Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
16272667|NCT00845325|Behavioral|Group One|They will begin exercises on the day after surgery and perform them three times daily for two weeks. The patients will have no restrictions concerning activity or return to work.
16272668|NCT00845325|Behavioral|Control Group Two|The patients will be restricted from using that hand during its implementation. One week following surgery the splint will be removed and the patient will be instructed to begin activity without restriction.
16272669|NCT00845299|Drug|Latanoprost punctal plug|Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.
16272670|NCT00845299|Drug|artificial tears preserved with Benzalkonium Chloride|
16272671|NCT00845286|Behavioral|Munich Marathon|42,195 km marathon run
16272672|NCT00845273|Drug|Pegaptanib sodium|"Macugen Intravitreous Injection Kit 0.3mg depending on the Investigator prescription.
~Frequency and duration are according to Package Insert as follows. Pegaptanib sodium is administered intravitreously once every 6 weeks at a dose level of 0.3 mg (on an oligonucleotide of pegaptanib basis )."
16272673|NCT00845260|Behavioral|Internet-based cognitive behavior therapy (CBT).|Self-help program and guidance by psychologist via e-mail during 10 weeks.
16272674|NCT00845260|Behavioral|Group CBT|Group cognitive behavior therapy (CBT) during 10 weeks.
16272675|NCT00845247|Other|Nurse case management|Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
16272676|NCT00845234|Behavioral|Intervention|Intervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration.
16272677|NCT00845221|Drug|Imatinib mesylate 100 mg (Glivec)|260 mg/m2/day tablets
16272678|NCT00845208|Behavioral|Network Support|12 Weekly sessions intended to help patients change their social networks to be more supportive of abstinence
16272679|NCT00845195|Drug|Olopatadine HCl Nasal Spray, 0.6%|2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
16272680|NCT00845195|Drug|Azelastine HCl Nasal Spray, 0.1%|2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
16272681|NCT00845182|Drug|Pioglitazone|Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months
16272682|NCT00845182|Drug|Exenatide|Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months
16272683|NCT00845182|Drug|Pioglitazone and Exenatide|Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months
16272684|NCT00845169|Procedure|Forearm vascular study|Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of nitric oxide synthase inhibitors L-NMMA (2-8 µg/min), S-methionyl-L-citrulline (25-200 nmol/min) and 1400W (100-1000 nmol/min) and positive control norepinephrine (60-540 pmol/min)
16272685|NCT00845156|Dietary Supplement|Alpha Lipoic Acid|Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily
16272686|NCT00845130|Biological|ascorbic acid (Vitamin C)|ascorbic acid IV 1 g/kg
16272687|NCT00845117|Procedure|Cultivated limbal stem cell graft transplantation|A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye.
16272688|NCT00845104|Drug|fludarabine phosphate|Given IV
16272689|NCT00845104|Biological|rituximab|Given IV
16272690|NCT00845104|Biological|bevacizumab|Given IV
16272691|NCT00845104|Other|laboratory biomarker analysis|Correlative studies
16272692|NCT00845104|Other|flow cytometry|Correlative studies
16272693|NCT00845104|Genetic|polymerase chain reaction|Correlative studies
16272703|NCT00845039|Biological|IMC-A12 (cixutumumab)|IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance
16272704|NCT00845026|Drug|LY2140023|80mg, oral tablets,twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40mg or a maximum of 160mg.
16272705|NCT00845026|Drug|aripiprazole|10mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20mg, 2-10mg oral tablets,once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 30mg (3-10mg oral tablets).
16272706|NCT00845026|Drug|olanzapine|10mg dose (2-5mg oral tablets) once every evening, for 3 days. Followed by an increase to 15mg (3-5mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 20mg (4-5mg oral tablets).
16272707|NCT00845026|Drug|risperidone|2mg dose, 2-1mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4mg (4-1mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2mg/day or a maximum of 6mg/day (6-1mg tablets).
16272708|NCT00845000|Drug|SCH 420814 10 mg|one 10-mg capsule, orally, at hour 0 of treatment period
16272709|NCT00845000|Drug|SCH 420814 100 mg|single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
16272710|NCT00845000|Drug|Placebo|Placebo capsule, oral, at hour 0 of treatment period
16272711|NCT00845000|Drug|Levodopa|levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
16272712|NCT00845000|Drug|Carbidopa|one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period
16272713|NCT00844974|Other|Prevalence|Mood and cognitive assessments
16272714|NCT00844961|Behavioral|Internet delivered cognitive behavior therapy|10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.
16272715|NCT00844922|Drug|SCH 900636|"Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the usual treatment for psychotic major depression."
16272716|NCT00844922|Drug|Placebo|Placebo
16272717|NCT00844909|Drug|CNTO 136|
16272718|NCT00844896|Behavioral|DEF-only|"The DEF protocol is from the National Child Traumatic Stress Network (NCTSN). DEF provides a sequential methodology for clinicians to assess medically traumatized children and their families and to plan specific interventions for them.
~In the present study, the DEF intervention is both a generalized approach taught to all Shriners Hospitals for Children (SHC)- Boston clinical staff, and for those participants of the present study, consists of an optional meeting with a member of the SHC Psychiatry Department. During this meeting, parents will have the chance to review any areas of pain, anxiety, or support that came up during their interviews or any other areas of concern about their child or his/her hospitalization that they wish to raise."
16272719|NCT00844896|Behavioral|DEF + COPE|"All enrolled participants will be offered the chance to meet with a psychiatric clinician for the DEF component of the intervention.
~For those assigned to receive COPE (Creating Opportunities for Parent Empowerment), parents will receive one of two versions of the materials: one for children less than one year old, and one for children ages 1-5 years. The COPE program was adapted for children with burns and developed to target major stressors that parents experience when their children are hospitalized, such as the loss of parental control. COPE also contains a behavioral component to help parents to carry out the recommendations provided to them. Each of these versions of the COPE program is essentially self-administered to parents via audio tapes and activity workbooks."
16272720|NCT00844883|Drug|sorafenib|sorafenib: given 400 mg twice per day for as long as it is beneficial
16272721|NCT00844883|Procedure|LC Bead-TACE|"LC Beads loaded with doxorubicin
~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
16272722|NCT00844870|Behavioral|stabilization training|training of arm function with the trunk stabilized
16272723|NCT00844870|Behavioral|auditory training group|response to an auditory signal
16272724|NCT00844857|Drug|Olanzapine Fluoxetine Combination (OFC)|OFC doses are capsules of 3 milligrams (mg) olanzapine and 25 mg fluoxetine (3/25), 6/25, 12/25, 6/50, or 12/50 mg to be taken orally once daily in the evening for 8 weeks.
16272725|NCT00844857|Drug|Placebo|Orally, once daily in the evening for 8 weeks.
16272726|NCT00844844|Drug|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
16272727|NCT00844831|Drug|Lubiprostone|24 mcg bid for 28 days
16272728|NCT00844818|Behavioral|Telephone Quitline Enrollment|The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.
16272729|NCT00844805|Drug|Infliximab|
16272730|NCT00844805|Drug|Placebo|
16272731|NCT00844805|Drug|Naproxen|
16272732|NCT00844792|Dietary Supplement|Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E|Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
16272733|NCT00844792|Drug|Placebo|Twice a day with meals.
16272734|NCT00844779|Procedure|Bariatric surgery|Gastric bypass.
16272735|NCT00844779|Procedure|cholecystectomy or benign liver tumor removal|cholecystectomy or benign liver tumor removal
16272736|NCT00844753|Drug|atomoxetine|atomoxetine
16272737|NCT00844753|Drug|Placebo|Placebo + parent management treatment
16272738|NCT00844753|Behavioral|Parent Management Training|
16272739|NCT00844740|Drug|Cinacalcet|Stable patients with XLH already treated with Phosphate and calcitriol will add Cinacalcet to their treatment regimen. Sequential monitoring of blood nand urine biochemical variables will follow, based on which adjustments to the doses of the 3 medications will be done.
16272740|NCT00844727|Drug|Rofecoxib|
16272741|NCT00844727|Drug|placebo|placebo pills
16272742|NCT00844714|Drug|Rituxan|1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study
16272743|NCT00844688|Drug|sorafenib|"Patients will be treated with 400 mg oral sorafenib twice a day on a continuous basis. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached:
~Progression of disease.
~The patient is unlikely to benefit from further treatment as
~Judged by the Investigator.
~Intolerable toxicity of the drugs.
~Withdrawal of consent for any reason."
16272744|NCT00844688|Drug|Gemcitabine|"Patients will be treated with Gemcitabine 1000mg/m2 administered on day 1 & 8 of a 4 week cycle. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached:
~Progression of disease. The patient is unlikely to benefit from further treatment as
~Judged by the Investigator.
~Intolerable toxicity of the drugs. Withdrawal of consent for any reason."
16272745|NCT00844675|Drug|rabeprazole|The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).
16272746|NCT00844675|Drug|placebo|The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).
16272747|NCT00844662|Drug|Fermagate|Film coated tablet 500mg
16272748|NCT00844662|Drug|Sevelamer hydrochloride|Tablet 800mg
16272749|NCT00844649|Drug|Albumin-bound paclitaxel (ABI-007)|ABI-007 125 mg/m^2 administered by intravenous infusion
16272750|NCT00844649|Drug|Gemcitabine|Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
16272751|NCT00844636|Device|Sharp needle|
16272752|NCT00844636|Device|Blunt needles|
16272753|NCT00844623|Genetic|TK99UN|escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
16272754|NCT00844597|Drug|AVI-4658 for Injection|AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline in 6 dose cohorts.
16272755|NCT00844584|Procedure|epicardial radiofrequency ablation|epicardial radiofrequency ablation to treat atrial fibrillation under totally thoracoscope
16272756|NCT00844571|Other|E-learning program|Participants are committed to accomplish the program in approximately 2 hours. Additionally to these mandatory hours, they were able to access the e-learning program at any time and place.
16272757|NCT00844558|Other|Gait Training|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
16272758|NCT00844558|Other|Control|There is no intervention associated with this arm of the study
16272759|NCT00844545|Drug|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
16272760|NCT00844532|Device|Absolute Pro™ Peripheral Self-Expanding Stent System|Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
16272761|NCT00844519|Drug|Maraviroc|For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
16272762|NCT00844519|Drug|placebo|For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
16272763|NCT00844506|Drug|P53-SLP vaccine|The P53-SLP vaccine is a vaccine consisting of a total of 10 long (30 amino acids on average length) peptides, covering the p53 protein sequence from amino acid 70 to 251, combined with Montanide ISA51 an adjuvant with a sustained dendritic cell activating ability. Patients will be immunised subcutaneously with the peptide vaccine four times with a three week interval (300μg/peptide).
16272764|NCT00844506|Drug|Cyclophosphamide|Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.
16272765|NCT00844493|Biological|E coli strain H10407 and buffer|7 or 8 logs of the bacteria with bicarbonate buffer
16272766|NCT00844493|Biological|E coli strain H10407 and buffer|Bacteria in a dose of 8 logs with CeraVacx buffer
16272767|NCT00844493|Biological|E coli strain H10407 and buffer|Bacteria in a dose of 7 logs and CeraVacx buffer
16272768|NCT00844493|Biological|E coli H10407 and buffer|Bacteria in a dose of 8 logs with bicarbonate buffer
16272769|NCT00844480|Drug|zoledronic acid|zoledronic acid, 5mg, iv
16272770|NCT00844480|Drug|placebo|iv
16272771|NCT00844467|Biological|serotypes and resistance|screening patients with invasive pneumococci
16272772|NCT00844454|Procedure|multi-pronged ethanol ablation|Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.
16272773|NCT00844454|Procedure|radiofrequency ablation|Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.
16272774|NCT00844441|Other|medical chart review|
16272775|NCT00844441|Other|questionnaire administration|
16272776|NCT00844441|Procedure|quality-of-life assessment|
16272777|NCT00844428|Drug|eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
16272778|NCT00844415|Drug|dabigatran etexilate|2.14 mg/kg BID to a max 150 mg BID
16272779|NCT00844402|Drug|Atorvastatin|oral, 10 mg, daily, 48 weeks
16272813|NCT00844194|Drug|Duloxetine 120 mg QD|given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
16272780|NCT00844389|Device|Near to infrared light retinal stimulation|Patients will be stimulated with 660 nm light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.
16272781|NCT00844389|Device|Green light stimulation|Patients will be stimulated with 530 nm LED light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.
16272782|NCT00844376|Drug|Atorvastatin suspension|A single dose of 80 mg Atorvastatin suspension
16272783|NCT00844376|Drug|Lipitor|A single dose of 80 mg Lipitor tablet
16272784|NCT00844363|Procedure|NB-UVB|UVB light will be administered to the entire body except for the genitals in men and eyelids, which will be shielded.NB-UVB dosing is increased by 5-20% increments in exposure time, depending on response of the patient.
16272785|NCT00844350|Drug|letrozole , oxytocin,hCG,clomiphene citrate|
16272786|NCT00844337|Drug|Gentamicin & Amoxicillin x 7days|"Injectable gentamicin once daily and oral amoxicillin twice daily for seven days.
~The dose for gentamicin is 4 - 5 mg/kg/24 hours. The dose for amoxicillin is 90-115 mg/kg/day."
16272787|NCT00844337|Drug|Penicillin & gentamicin x 2 d + Amoxicillin X 5 d|Injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days. The dose for penicillin is 40,000 - 50,000 U/kg/24 hours, the dose for gentamicin is 4 - 5 mg/kg/24 hours, and the dose for amoxicillin is 90-115 mg/kg/day.
16272788|NCT00844337|Drug|Standard reference therapy|Injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. The penicillin dose is 40,000 - 50,000 U/kg/24 hours, and the gentamicin dose is 4 - 5 mg/kg/24 hours.
16272789|NCT00844324|Drug|Candesartan cilexetil|Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose
16272790|NCT00844324|Drug|Candesartan cilexetil|Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose
16272791|NCT00844311|Drug|rFSH|150 iu/day of rFSH
16272792|NCT00844311|Drug|human chorionic gonadotropin|50 iu/day of hCG from stimulation day 1
16272793|NCT00844311|Drug|human chorionic gonadotropin|100 iu/day of hCG from stimulation day 1
16272794|NCT00844311|Drug|human chorionic gonadotropin|150 iu/day of hCG from stimulation day 1
16272795|NCT00844298|Drug|Nilotinib+mVPD|"Induction:
~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
~Vincristine 2 mg iv push (d1, 8, 15, 22)
~Prednisolone 60 mg/m2/day po (d1-28)
~Nilotinib 400mg bid/d (d8-)
~Consolidation A (cycle1)
~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
~Vincristine 2 mg iv (d1, 8)
~Prednisolone 60 mg/m2/day po (d1-14)
~Nilotinib 400mg bid/d
~Consolidation B (cycles 2&4)
~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)
~Nilotinib 400mg bid/d
~Consolidation C (cycles 3&5)
~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,
~Nilotinib 400mg bid/d
~Maintenance
~◦Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)
~Consider alloHCT"
16272796|NCT00844285|Drug|Cimzia|The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
16272797|NCT00844272|Behavioral|Psychoeducation|"Group-therapeutic intervention with 12 sessions plus 5 update sessions with 24-week therapy duration and/or 12 sessions plus 10 update sessions with 48-week therapy duration Module I: Create understanding, resources, problems and solutions Module II: Information on hepatitis C infection Module III: Information on treatment Module IV: Specific information on depression and withdrawal symptoms under interferon The meetings take a minimum of 60 min. time, should be once weekly. The group size should lie between 6 and 12 participants.
~The group leaders are trained in performance of the psycho-education."
16272798|NCT00844246|Other|Developmental screening using ASQ and MCHAT|In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.
16272799|NCT00844246|Other|Developmental screening using ASQ and MCHAT|Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits. The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits. Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor. The PCP will then score the screening tool and interpret the test results. Developmental counseling and/or anticipatory guidance will be provided, as per usual care. EI referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
16272800|NCT00844233|Device|Irinotecan Bead|Irinotecan eluting bead
16272801|NCT00844220|Procedure|CT/MR|CT/MRI-directed clinical management strategy
16272802|NCT00844220|Procedure|Catheterization|Standard clinical management directed by conventional coronary angiography
16272803|NCT00844207|Drug|Fixed combination of Azithromycin and Chloroquine|Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.
16272804|NCT00844207|Drug|Azithromycin and Chloroquine|Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.
16272805|NCT00844194|Drug|Duloxetine 60 mg QD|given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
16272806|NCT00844194|Drug|Duloxetine 60 mg QD|given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
16272807|NCT00844194|Drug|Duloxetine 30 mg QD|given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
16272808|NCT00844194|Drug|Duloxetine 30 mg QD|given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
16272809|NCT00844194|Drug|Duloxetine 90 mg QD|given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
16272810|NCT00844194|Drug|Duloxetine 90 mg QD|given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
16272811|NCT00844194|Drug|Duloxetine 60 mg QD|given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
16272812|NCT00844194|Drug|Duloxetine 60 mg QD|given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
16273565|NCT00838175|Procedure|suture mediated closure|Suture mediated closure of femoral venous access
16272814|NCT00844194|Drug|Duloxetine 30 mg QD|given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
16272815|NCT00844194|Drug|Duloxetine 30 mg QD|given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
16272816|NCT00844194|Drug|Duloxetine 120 mg QD|given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
16272817|NCT00844168|Drug|sorafenib tosylate|Given orally
16272818|NCT00844168|Other|laboratory biomarker analysis|Correlative studies
16272819|NCT00844155|Drug|Oseltamivir 75 mg|The primary objective of this study is to demonstrate that the pharmacokinetics of oseltamivir, when given enterally to critically ill patients, in the standard treatment dose of 75 mg or double that dose, 150 mg, will yield a plasma concentration - versus - Time Area under the curve (AUC) similar to that observed in adults with influenza treated successfully with a dose of 75 mg, that the disposition characteristics are dose proportionate and are not altered by the concomitant administration of enteral feedings.
16272820|NCT00844142|Drug|Etanercept 25mg|patients will receive etanercept 25mg twice weekly
16272821|NCT00844142|Drug|Sulfasalazine|in this arm patients will receive sulfasalazine 2000- 3000mg per os daily
16272822|NCT00844116|Device|spirometry|Conventional and telematic spirometry
16272823|NCT00844103|Drug|AZD8566|10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee
16272824|NCT00844103|Drug|Placebo|10ml oral solution administered once a day over 10 days.
16272825|NCT00844090|Drug|methylphenidate or placebo|treat apathy to improve diabetes self care behaviors thereby improving glycemic control
16272826|NCT00844064|Drug|AP 12009|"Initial scheme: AP 12009 (trabedersen), dose escalation scheme, continuous intravenous infusion (7 days), every other week, up to 10 cycles.
~Modified scheme: AP 12009 (trabedersen), dose escalation scheme, continuous intravenous infusion (4 days), every other week, up to 10 cycles"
16272827|NCT00844051|Biological|School-based influenza vaccination program|School-based influenza vaccination program
16272828|NCT00844025|Behavioral|Pharmacist intervention|Medication review, medication reconciliation, and pharmacotherapy recommendation.
16272829|NCT00844012|Drug|Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)|Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a continuous regimen.
16272830|NCT00844012|Drug|Cyclic OC (clormadinone acetate plus ethinil-estradiol)|Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a cyclic regimen.
16272831|NCT00843986|Drug|conivaptan|Premix bag
16272832|NCT00843986|Drug|placebo|Premix bag
16272833|NCT00843973|Procedure|iliac crest bone graft|iliac crest bone graft procedure
16272834|NCT00843973|Procedure|Reamer Irrigator Aspirator|Reamer Irrigator Aspirator (RIA) Procedure
16272835|NCT00843960|Behavioral|behavioral adaptation and symptom management|behavioral adaptation and symptom management
16272836|NCT00843947|Procedure|Reduced Intensity Stem Cell Transplantation|Reduced Intensity Stem Cell Transplantation
16272837|NCT00843934|Drug|epirubicin|Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.
16272838|NCT00843934|Drug|Cisplatin|Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.
16272839|NCT00843921|Drug|N-carbamylglutamate|100 mg/kg/day or 2.2 g/M2/day in 3-4 divided doses for 3 days
16272840|NCT00843908|Device|Tension Free Vaginal Tape|Tension Free Vaginal Tape inserted in the conventional manner in a theatre environment
16272841|NCT00843908|Device|Miniarc|The Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia
16272842|NCT00843895|Biological|pneumococcal conjugate vaccine(prevenar)|to see the vaccine impact on pneumococcal diseases
16272843|NCT00843882|Biological|Epoetin Alfa|Given SC
16272844|NCT00843882|Other|Laboratory Biomarker Analysis|Correlative studies
16272845|NCT00843882|Drug|Lenalidomide|Given PO
16272846|NCT00843856|Drug|tacrolimus|tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
16272847|NCT00843856|Drug|tacrolimus and mycophenolate mofetil|tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
16272848|NCT00843843|Device|Bright light box|Bright light of about 5000 lux, administered while sitting at a desk.
16272849|NCT00843830|Radiation|tumoral irradiation|On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
16272850|NCT00843830|Biological|Dendritic cell vaccination|Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
16272851|NCT00843817|Drug|Pulmozyme|Pulmozyme® 2.5mg by inhalation
16272852|NCT00843791|Drug|placebo|treatment with placebo for 3 months
16272853|NCT00843791|Drug|pioglitazone|treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
16272854|NCT00843778|Biological|Certolizumab Pegol|"200 mg every two weeks
~Certolizuimab Pegol 200 mg every two weeks Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
16272932|NCT00842985|Drug|drug condition|Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
16272933|NCT00842959|Device|Invent ZO|monofocal aspheric IOL for implantation into capsular bag
16274610|NCT00829842|Other|oral hygiene|oral hygiene with 0.12% chlorexidine
16272855|NCT00843765|Other|acupuncture, massage and basic TCM treatment|"During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education.
~After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes."
16272856|NCT00843765|Other|rehabilitation and WM basic treatment|"there two steps:
~during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education
~After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet"
16272857|NCT00843739|Device|EMST - Active Treatment|Hand held device used for strengthening expiratory muscles
16272858|NCT00843739|Device|sham EMST|Four week sham device training program
16272859|NCT00843726|Radiation|Arm 1 stereotactic body radiation therapy|Patients undergo 1 high-dose fraction
16272860|NCT00843726|Radiation|Arm II stereotactic body radiation therapy|Patients undergo 3 high-dose fractions
16272861|NCT00843713|Drug|raltegravir|For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
16272862|NCT00843713|Drug|Placebo|For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
16272863|NCT00843700|Behavioral|Interpersonal Psychotherapy-Trauma in Community Settings|Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
16272864|NCT00843700|Behavioral|Treatment as Usual|Individual psychotherapy following usual care practice in a community mental health center.
16272865|NCT00843687|Drug|Risperidone long-acting injectable|
16272866|NCT00843661|Drug|ezetimibe|10 mg ezetimibe/day
16272867|NCT00843661|Drug|fenofibrate|200 mg fenofibrate/day
16272868|NCT00843661|Drug|pravastatin|40 mg pravastatin/day
16272869|NCT00843635|Drug|Tadalafil|Given orally
16272870|NCT00843635|Other|Placebo|Given orally
16272871|NCT00843622|Drug|Low-nitrosamine smokefree tobacco product for oral use|Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
16272872|NCT00843622|Other|Non-tobacco, non-nicotine placebo product|Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
16272873|NCT00843609|Device|Navigator continuous glucose monitor (Freestyle Navigator®)|Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %
16272874|NCT00843596|Procedure|cardiac surgery requiring ECC|the vacuum device is left on the 2 wounds (caused by the ECC cannulas) for 15 min (possible a second time of 15 min : 30 min max.)
16272875|NCT00843570|Drug|Nafarelin acetate, Oestradiol Valerate, Progesterone|Nafarelin acetate, Nasal spray, 400 mcg b.d., 4 weeks Oestradiol Valerate, tablet, 2mg o.d day 1-5, 2mg b.d. day 6-9, 2mg t.d.s day 10-13 (step-up protocol), 2mg q.d.s (if pregnancy confirmed, 4-10 weeks Progesterone, pessary, 200mg b.d. and t.d.s. (if pregnancy confirmed), 2-10 weeks
16272876|NCT00843544|Behavioral|Integrative Medicine|"Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:
~Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
~Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
~Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date."
16272877|NCT00843531|Drug|RAD001|5 mg/day PO (oral)
16272878|NCT00843531|Drug|erlotinib|100 mg/day (oral)
16272879|NCT00843518|Drug|LY451395|3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
16272880|NCT00843518|Drug|Placebo|Placebo orally twice daily for 12 weeks
16272881|NCT00843505|Behavioral|Telemedicine Smoking Cessation Program|Participants will receive four sessions of telemedicine smoking cessation counseling over an 8-week period. The telemedicine sessions will be delivered by two-way Webcams mounted on desktop computers in the doctors' offices.
16272882|NCT00843505|Behavioral|Telephone Quitline Smoking Cessation Program|Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.
16272883|NCT00843492|Drug|Fondaparinux sodium|After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg [0.5mL] (1.5 mg [0.3mL] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.
16272884|NCT00843492|Drug|Nadroparin|After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.
16272934|NCT00842959|Device|XL Stabi ZO|monofocal aspheric IOL for implantation into capsular bag
16272885|NCT00843466|Other|Mild, moisturizing hand cleanser|"Hand cleanser ingredient list:
~Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water"
16272886|NCT00843453|Other|blood collection|blood collection
16272887|NCT00843453|Drug|treatment (cyanocobalamin nasal spray)|cyanocobalamin nasal spray -- 500 mcg q week for eight weeks
16272888|NCT00843440|Drug|Bevacizumab|5 mg / kg every 14 days with a total of 6 injections.A two-phase Gehan method will be used with a first phase designed to eliminate a non effective treatment quickly and a second phase allowing assessment of efficacy.
16272889|NCT00843427|Behavioral|CIAT|Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
16272890|NCT00843388|Drug|Spironolacton (hexalacton(R))|Tablet Spironolacton 25 mg OD
16272891|NCT00843388|Drug|placebo tablet|placebo tablet 25 mg OD
16272892|NCT00843362|Drug|Dinoprostone vaginal pessary|10 mg controlled-release dinoprostone pessary applied for 24 hours
16272893|NCT00843362|Drug|Dinoprostone vaginal gel|2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval
16272894|NCT00843349|Drug|Lanthanum Carbonate|Phosphorus binder
16272895|NCT00843349|Other|900 mg Phosphate Diet|Amount of phosphorus consumption in a day kept below 900 mg.
16272896|NCT00843349|Drug|LC Placebo|Placebo for Lanthanum Carbonate
16272897|NCT00843349|Other|Ad Libitum Diet|Patients continued to eat their usual diet.
16272898|NCT00843336|Behavioral|Electronic hormonal fertility monitoring|Use of an electronic hormonal fertility monitor that provides three levels of fertility; low, high, and peak. Monitor is based upon urinary levels of E3G (estrogen) and LH. Monitor readings are placed in an electronic charting system on the Internet.
16272899|NCT00843336|Behavioral|Self-monitoring|Self-monitoring of externally observed cervical mucus to determine level of fertility.
16272900|NCT00843323|Other|Methylaminolevulinate - photodynamic therapy|Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device
16272901|NCT00843310|Drug|Lenalidomide (Revlimid)|
16272902|NCT00843310|Drug|Melphalan|
16272903|NCT00843310|Drug|Dexamethasone|
16272904|NCT00843297|Device|Coolgard|invasive Cooling via femoral ICY-catheter
16272905|NCT00843297|Device|ArcticSun|Noninvasive surface-cooling by saline-cooled thermo-vest
16272906|NCT00843297|Other|Conventional treatment|Intensive care-treatment without cooling
16272907|NCT00843284|Drug|Pregabalin|Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks
16272908|NCT00843258|Device|Abduction treatment|Abduction treatment with a Frejka's pillow for 6 weeks
16272909|NCT00843245|Other|No intervention|No intervention
16272910|NCT00843219|Procedure|PET/CT Scan|PET/CT scan performed with elastic belt around lower chest/upper abdomen to track breathing motion.
16272911|NCT00843193|Drug|INTRAVENOUS GSK679586|GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump
16272912|NCT00843193|Drug|INTRAVENOUS PLACEBO|Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump
16272913|NCT00843193|Drug|FLUTICASONE PROPIONATE|Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.
16272914|NCT00843180|Other|massage|one to three massages per week by massage practitioner additional massages by resident parent who is being taught to massage her/his child
16272915|NCT00843167|Dietary Supplement|broccoli sprout extract|Given orally
16272916|NCT00843167|Other|placebo|Given orally
16272917|NCT00843154|Drug|Candesartan and standard chronic heart disease therapy|Candesartan 4mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for two weeks; then Candesartan increased up to 32mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
16272918|NCT00843154|Drug|Standard chronic heart disease therapy|Candesartan placebo-matching tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
16272919|NCT00843141|Behavioral|cognitive computerized training|cognitive computerized training utilizing executive attention tasks
16272920|NCT00843141|Behavioral|simple cognitive computerized training|simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
16272921|NCT00843128|Device|robot-assisted gait training (RAGT)|20 patients will be treated with RAGT, 12 sessions over three weeks.
16272922|NCT00843128|Device|conventional walking training (CWT)|The control group will be treated by CWT, 12 sessions in three weeks.
16272923|NCT00843115|Other|donepezil|Routine clinical practice of prescribing donepezil as per the Canadian label. No drug was supplied as part of this study
16272924|NCT00843089|Other|Education|Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse
16272925|NCT00843063|Drug|pantoprazole vs famotidine|pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
16272926|NCT00843050|Drug|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
16272927|NCT00843037|Drug|Sunitinib|50 mg oral dose daily for 4 weeks, 2 week rest period (repeating 6 week cycles)
16272928|NCT00843024|Drug|Sumatriptan and Naproxen Sodium|Sumatriptan succinate and naproxen sodium
16272929|NCT00843024|Drug|Placebo|Placebo to match
16272930|NCT00843011|Drug|Orvepitant|Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.
16272931|NCT00842998|Drug|Trastuzumab or Lapatinib|Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally
16272935|NCT00842946|Behavioral|Exposure w/ Acceptance-Based Rationale|"Treatment focuses on the ineffectiveness of participants' past attempts to control or reduce their anxiety in public speaking situations. Acceptance of one's private experiences (thoughts, feelings, sensations) will be introduced. Willingness to experience unwanted thoughts and feelings while simultaneously engaging in valued activities, especially those related to public speaking, is stressed. Techniques designed to foster psychological acceptance are practiced prior to and during exposure exercises, as well as assigned for homework between sessions."
16272936|NCT00842946|Behavioral|Exposure w/ Habituation-Based Rationale|Exposure to feared public speaking situations are accompanied by explanations of behavioral principles, including classical/operant conditioning and habituation. The process of associating public speaking situations with unwanted feelings of anxiety will be discussed, as well as negative reinforcement of escape and avoidance behaviors. The underlying principle of habituation is reviewed. When engaging in exposure exercises (both in session and assigned homework exercises), participants will be encouraged to remain in the feared speaking situation until their subjective ratings of anxiety decrease.
16272937|NCT00842933|Drug|Corticosteroid|Cessation of corticosteroids 24 hours after cessation of vasopressors
16272938|NCT00842933|Drug|Corticosteroid|Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
16272939|NCT00842920|Drug|Simvastatin 60 mg|60 mg once daily
16272940|NCT00842920|Drug|Placebo|one tablet once daily
16272941|NCT00842920|Drug|Simvastatin 20 mg|20 mg once daily
16272942|NCT00842907|Drug|oral isotretinoin|one 20.0 mg capsule, once a day, every other day, during 24 weeks
16272943|NCT00842907|Drug|Tretinoin|0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
16272944|NCT00842894|Drug|insulin detemir|Safety and effectiveness data collection in connection with the use of the drug.
16272945|NCT00842894|Drug|biphasic insulin aspart 30|Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.
16272946|NCT00842881|Device|Healingstone navel belt|6~8hours/day for 3months
16272947|NCT00842842|Procedure|tack fixation of mesh|tack fixation of mesh
16272948|NCT00842842|Procedure|glue fixation of mesh|glue fixation of mesh
16272949|NCT00842829|Drug|Fentanyl Buccal Tablet (FBT)|FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800 mcg). For the open-label treatment and continuation periods, single dose tablets at the effective dose identified during the titration period were used. The maximum dose allowed per breakthrough pain (BTP) episode was 800 mcg. On any single day, participants were not to use FBT for more than 4 BTP episodes.
16272950|NCT00842816|Drug|ST101|10 mg; administered once/day
16272951|NCT00842816|Drug|ST101|60 mg; administered once/day
16272952|NCT00842816|Drug|ST101|120 mg; administered once/day
16272953|NCT00842816|Drug|Placebo|placebo tablets to match ST101 tablets
16272954|NCT00842803|Drug|Albumin infusion (25% albumin)|Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
16272955|NCT00842777|Behavioral|Parent manualized group treatment|"Parent manualized group treatment in childhood obesity; 10 manualized group treatment over a 6 months period.
~Ten sessions will be conducted with the following content: 1) Expectancies and goal setting,; 2) Taking to the child about overweight; 3) Daily physical activity; 4) Everyday meals and nutrition; 5) Mastery and motivation; 6) Guidance and limit setting; 7) Who should join the team? The role of siblings and the social network; 8) Parents' history of eating and physical activity; 9) Self-concept and body image; and 10) Vacations and parties.
~Thereafter booster-meetings every third month over 1,5 years, in all 2 years treatment"
16272956|NCT00842777|Behavioral|Parent self-help groups|Professionals initiate and organize the self-help groups initially and attend the two first meetings. Their role will be to organize group and facilitate group rules governing group behaviors to be formed. The sharing of experiences, feelings, and thoughts concerning being a parent to an overweight child is encouraged, in addition to sharing tips and advices concerning managing their child's behavior. The groups will not receive any teaching or counseling concerning eating and physical activity.
16272957|NCT00842764|Procedure|Holmium: YAG laser|Minimally Invasive Holmium:YAG laser Blepharoplasty
16272958|NCT00842751|Drug|First Intervention (7 days)|Acyline 300mcg/kg subcutaneous (days 1, 15 & 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo
16272959|NCT00842751|Other|First Washout (7 days)|Washout of 7 days between each of the 3 treatment arms
16272960|NCT00842751|Drug|Second Intervention (7 days)|Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally
16272961|NCT00842751|Drug|Third Intervention (7 days)|Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally
16272962|NCT00842751|Other|Second wash-out period|Washout of 7 days between each of the 3 treatment arms
16272963|NCT00842738|Behavioral|Mindfulness meditation|Mindfulness meditation
16272964|NCT00842738|Other|No meditation|Health care services as usual
16272965|NCT00842738|Other|Controls|No intervention
16272966|NCT00842712|Drug|Cilengitide|Cilengitide (Cil) will be administered at a dose of 1000 milligram (mg) as intravenous infusion twice weekly over 1 hour on Days 1 and 4.
16272967|NCT00842712|Drug|Cilengitide|Cil will be administered at a dose of 2000 mg as intravenous infusion twice weekly over 1 hour on Days 1 and 4.
16272968|NCT00842712|Drug|Cetuximab|Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) as intravenous infusion over 2 hours on Day 1.
16272969|NCT00842712|Drug|Cisplatin|Cisplatin (Cis) will be administered at a dose of 75 mg/m^2 as intravenous infusion on Day 1.
16272970|NCT00842712|Drug|Cisplatin|Cis will be administered at a dose of 80 mg/m^2 as intravenous infusion on Day 1.
16272971|NCT00842712|Drug|Gemcitabine|Gemcitabine (Gem) will be administered at a dose of 1250 mg/m^2 as intravenous infusion on Days 1 and 8.
16272972|NCT00842712|Drug|Vinorelbine|Vinorelbine (Vin) will be administered at a dose of 25 mg/m^2 as intravenous infusion on Days 1 and 8.
16273016|NCT00842465|Other|ultrasonography (pelvis and breast), bone mineral density|ultrasonography (pelvis and breast), bone mineral density
16272973|NCT00842712|Drug|Cilengitide|Cil will be administered at a dose of 2000 mg as intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle until progressive disease, death, unacceptable toxicity, or consent withdrawal.
16272974|NCT00842712|Drug|Cilengitide|Cil will be administered at a dose of 2000 mg as intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy until progressive disease, death, unacceptable toxicity, or consent withdrawal.
16272975|NCT00842712|Drug|Cetuximab|Cetuximab will be administered at a dose of 400 mg/m^2 as intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal.
16272976|NCT00842712|Drug|Chemotherapy|Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle will be administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
16272977|NCT00842686|Drug|bevacizumab, capecitabine|bevacizumab 5mg/kg days -15,1,15,29 capecitabine 1250 mg/square m/day during radiotherapy radiotherapy 50,4 Gy (1,8 Gy per fraction)
16272978|NCT00842673|Drug|ST101|30 mg; administered once/day
16272979|NCT00842673|Drug|ST101|90 mg; administered once/day
16272980|NCT00842673|Drug|ST101|180 mg; administered once/day
16272981|NCT00842673|Drug|Placebo|placebo to match ST101 tablets
16272982|NCT00842660|Drug|Gemzar (gemcitabine)|Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride
16272983|NCT00842634|Biological|ZFN modified T cells|A single infusion of 5-10 billion ZFN Modified CD4+ T Cells
16272984|NCT00842634|Other|Structured Treatment Interruption|Stop Taking HAART Medication for up to 12 weeks (4 weeks after infusion to 16 weeks after infusion)
16272985|NCT00842621|Procedure|Clinical Evaluations|All clinical evaluations should be performed greater than 30 days from illness or hospitalization. Participants will have weight, height, body mass index (BMI), heart rate, respiratory rate, blood pressure (systolic and diastolic) and pulse oximetry recorded while at rest on room air by clinical staff. Cardiac examination will be performed by echocardiogram.
16272986|NCT00842621|Other|Laboratory Studies|"Blood for:
~Complete Blood Count with Differential, Reticulocyte Count, Micronuclei enumeration, α-globin genotype, G6PD activity, genotype, SNP array,
~Serum for:
~Soluble VCAM-1, ICAM-1, Soluble CD40L, Arginase, Endothelin-1, Prothrombin Fragment 1+2, IL-6, -8, -10, Soluble E-selectin, NOx, Haptoglobin, Tumor necrosis factor alpha
~Plasma for:
~Chemistry 18, Cystatin-C, Ferritin, Lactate Dehydrogenase, C-reactive protein, Erythropoietin, NT-proBNP, Haptoglobin, Von Willibrand Factor Antigen, D-dimer, Factor VIII Assay, Quantitative amino acids, Free hemoglobin, Tumor necrosis factor- α, Thrombin-Antithrombin complex, endothelin-1
~Urine for:
~Urinalysis, Urine spot protein, creatinine, Microalbumin, Urine hemosiderin, Urine hepcidin"
16272987|NCT00842608|Behavioral|Reduced exposure to anticholinergics|"Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.
~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol"
16272988|NCT00842608|Procedure|Reduced exposure to benzodiazepines|Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
16272989|NCT00842608|Drug|Haloperidol|0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital
16272990|NCT00842608|Procedure|Usual care|May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
16272991|NCT00842595|Drug|rituximab|6 courses every 28 days
16272992|NCT00842595|Drug|vinorelbine|6 courses every 28 days
16272993|NCT00842595|Drug|ifosfamide|6 courses every 28 days
16272994|NCT00842595|Drug|Mitoxantrone|6 courses every 28 days
16272995|NCT00842595|Drug|Prednisone|6 courses every 28 days
16272996|NCT00842582|Drug|Azacitidine|Azacitidine 20 milligrams per meter squared subcutaneous once daily for 7 days.
16272997|NCT00842582|Drug|Azacitidine|Azacitidine 40 milligrams per meter squared subcutaneous once daily for 7 days.
16272998|NCT00842582|Drug|Azacitidine|Azacitidine 75 milligrams per meter squared subcutaneous once daily for 7 days.
16272999|NCT00842556|Drug|Dapagliflozin|Tablets, Oral, 20 mg, Single Dose
16273000|NCT00842556|Drug|Glimepiride|Tablets, Oral, 4 mg, Single Dose
16273001|NCT00842556|Drug|Sitagliptin|Tablets, Oral, 100 mg, Single Dose
16273002|NCT00842543|Dietary Supplement|Fruit and Vegetable Juice Concentrate (FVJC)|Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
16273003|NCT00842543|Dietary Supplement|Placebo|Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
16273004|NCT00842530|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous
16273005|NCT00842530|Biological|Inactivated rabies virus vaccine|0.5 mL, Subcutaneous
16273006|NCT00842530|Biological|Placebo|Sodium chloride 0.9%
16273007|NCT00842517|Behavioral|Contingency Management|
16273008|NCT00842504|Drug|Micafungin|3 mg/kg IV once over 1 hour
16273009|NCT00842491|Drug|endostar, cisplatin, capecitabine|"Product 1: endostar
~Dosing schedule: 15mg daily dose, d1-14
~Mode of administration: intravenously"
16273010|NCT00842491|Drug|capecitabine|"Product 2: capecitabine
~Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
~Mode of administration: orally"
16273011|NCT00842491|Drug|cisplatin|"Product 3: cisplatin
~Dosing schedule: 80mg/m2, day 1 of every 3 weeks
~Mode of administration: intravenously"
16273012|NCT00842478|Procedure|Toothbrushing|
16273013|NCT00842465|Biological|blood collection for hormonal status analysis|for hormonal status analysis
16273014|NCT00842465|Procedure|breast Biopsy or surgery|breast Biopsy or surgery
16273015|NCT00842465|Genetic|blood collection|blood collection for prlR gene sequencing
16273128|NCT00841607|Procedure|pancreaticojejunostomy vs pancreaticogastrostomy|
16273017|NCT00842452|Drug|topotecan hydrochloride|Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16273018|NCT00842452|Other|pharmacological study|Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.
16273019|NCT00842439|Behavioral|CBI|Participants will have have one hour sessions, once a week for 12 weeks, where they will meet with an interventionist to go over cognitive-behavioral skills.
16273020|NCT00842439|Dietary Supplement|NUT|Participants will be asked to take omega-3 supplements, calcium tablets, and multivitamins every day for 12 weeks.
16273021|NCT00842426|Behavioral|Self-management program (SM)|"Participants will attend a group orientation where the study nutritionist will provide an overview of the self-management lifestyle intervention program. Participants will receive instructions on how to use HeartHubTM, the American Heart Association's patient portal for information, tools, resources about cardiovascular risk assessment, goal setting, action planning, and self-monitoring.
~During the remainder of the 15-month intervention, participants will receive reminders on a regular basis to use the patient portal to assist in their ongoing self-management."
16273022|NCT00842426|Behavioral|Care management program (CM)|"In addition to participating in the activities described above, with the exception of the orientation session, participants in the Care Management Program will attend 12 weekly weight management classes during the initial 3 months. Classes will be co-led by a dietician and exercise specialist and will include a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by individual action-planning and goal-setting.
~During the remainder of the 15-month intervention, participants will continue to monitor their body weight, caloric intake, physical activity, and other data according to their care plan. In addition, study interventionist will follow up with participants regularly, via secure messaging or by phone, to provide ongoing counseling and support."
16273023|NCT00842400|Drug|Metformin, VI-0521, Sitagliptan, Probenecid|"This trial is an open-label, non-randomized, one-sequence crossover study.
~metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34
~sitagliptan 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39
~VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39)
~2 g (four 500 mg) probenecid tablets on Day 29."
16273024|NCT00842361|Drug|insulin degludec/insulin aspart|The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.
16273025|NCT00842361|Drug|biphasic insulin aspart 30|The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.
16273026|NCT00842348|Drug|lanreotide (Autogel formulation)|Autogel 120 mg
16273027|NCT00842335|Drug|JI-101|JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
16273028|NCT00842322|Behavioral|high fluid intake|fluid intake of 4 litres per day
16273029|NCT00842322|Behavioral|normal fluid intake|Fluid intake of 2 litres per day
16273030|NCT00842309|Drug|d-cycloserine|100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
16273031|NCT00842309|Drug|Placebo|Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
16273032|NCT00842296|Device|RF ablation (ClosureFAST)|Segmental RF Ablation with the CLF catheter
16273033|NCT00842283|Other|skin tissue sample|skin tissue sample
16273034|NCT00842270|Drug|AB1010|3 mg/kg/day
16273035|NCT00842270|Drug|AB1010|4,5 mg/kg/day
16273036|NCT00842270|Drug|AB1010|6 mg/kg/day
16273037|NCT00842270|Drug|placebo|matching placebo to AB1010 dosages
16273038|NCT00842257|Drug|panitumumab|Panitumumab is administered intravenously (IV) by an infusion pump through a peripheral line or indwelling catheter using a 0.2 or 0.22-micron in-line filter infusion set-up over 1 hour 15 minutes. The starting panitumumab dose is 6 mg/kg administered every 14 days for as long as patients are on study without evidence of disease progression or demonstrating intolerance to treatment. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual body weight at each visit. Panitumumab will be diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution (normal saline solution, supplied by the site). The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
16273039|NCT00842244|Drug|axitinib|Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16273040|NCT00842244|Drug|capecitabine|Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16273041|NCT00842244|Drug|cisplatin|Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m^2 on day 1.
16273042|NCT00842231|Other|Visual performance measures|Collection of visual performance measures in subjects with low levels of astigmatism.
16273043|NCT00842205|Drug|pegylated interferon|peg-IFN alfa 2a 180ug s.c. QW or peg-IFN alfa 2b 1.5 ug/kg s.c. QW
16273044|NCT00842205|Drug|Ribavarin|ribavirin 1000-1200mg p.o. daily 48weeks or ribavirin 100-1200mg p.o. daily 48 weeks
16273045|NCT00842192|Drug|insulin detemir|Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.
16273046|NCT00842166|Other|BLOOD DRAW|specific interview, sequential blood collection to allow virus isolation, molecular and serological diagnostics in patients
16273047|NCT00842153|Drug|Clobetasol propionate foam|Topical Clobetasol propionate foam
16273048|NCT00842153|Drug|Vehicle foam|Vehicle foam does not include the active drug.
16273049|NCT00842140|Drug|oral contraceptive|oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months
16273050|NCT00842140|Drug|Oral contraceptive plus spironolactone|The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
16273051|NCT00842140|Drug|Oral contraceptive plus metformin|Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin
16273052|NCT00842127|Drug|OROS-methylphenidate (Concerta)|dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks
16273053|NCT00842114|Biological|R+CVP+IFN|Immunochemotherapy
16273054|NCT00842101|Device|Quick Pressure Monitor|The monitor measures actively the actual pressure inside the compartment affected.
16273055|NCT00842088|Drug|Placebo|Matching placebo capsule. Administered orally once a day on dosing days.
16273056|NCT00842088|Drug|HQK-1001|HQK-1001 capsules. 10 mg/kg, 20 mg/kg or 30 mg/kg administered once a day on dosing days.
16273057|NCT00842075|Drug|pramlintide|subcutaneous injection (15 mcg initial dose)prior to meals
16273058|NCT00842062|Device|MyoScience Tissue Remodeling Device|Percutaneous treatment with the MyoScience device
16273059|NCT00842049|Device|Lumbar Drain (Medtronic lumbar drainage system)|Insertion of lumbar drain to drain cerebrospinal fluid
16273060|NCT00842049|Other|No lumbar drain|No lumbar drain
16273061|NCT00842036|Behavioral|Community Reinforcement and Family Training|Community Reinforcement and Family Training (CRAFT) is an intervention designed for the concerned significant other (CSO) of a drug or alcohol using loved one. The CRAFT intervention consists of approximately 12 sessions lasting 45-60 minutes. The goal of the CRAFT intervention is to train the CSO in new ways to interact with the person of concern (PC). There are four components that the CSO is trained on which include awareness training, community reinforcement training, treatment entry training, and CSO mood enhancement.
16273062|NCT00842036|Behavioral|Treatment Entry Training|Treatment Entry Training (TEnT) is a component of the Community Reinforcement and Family Training intervention and it is currently under investigation to determine if it is sufficient to produce the primary and most consistent outcome of CRAFT- treatment entry of the drug user. The intervention will consist of a minimum of 4 sessions and a maximum of 6 sessions that are each 45-60 minutes long. TEnT will include awareness training, safety training, and the Treatment Entry Training component of CRAFT.
16273063|NCT00842036|Behavioral|12- step Al/Nar- Anon Facilitation|The underlying philosophy of the 12- step approach for concerned significant others (CSO) is that the CSO is powerless to control the drinker/drug user and must detach, focusing instead on accepting the situation and on strengthening his or her mental health. Eight content areas are discussed with the CSO over the course of the intervention. There will be a minimum of 8 sessions and a maximum of 12 sessions that are each 45-60 minutes long.
16273064|NCT00842023|Drug|Nesiritide|Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
16273065|NCT00842023|Drug|Nitroglycerin|5-10 mcg/min titrating per protocol based on blood pressure
16273066|NCT00841971|Drug|Anidulafungin|200 mg IV loading dose followed by 100 mg qd for 21 days
16273067|NCT00841971|Drug|Fluconazole|400 mg IV for 21 days
16273068|NCT00841958|Procedure|Autologous bone marrow mononuclear stem cells or peripheral blood stem cells|Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%
16273069|NCT00841945|Drug|rituximab|RITUXIMAB 375 MG/M² IV DAY 1 or each course
16273070|NCT00841945|Drug|doxorubicin|doxorubicin 50 mg / m² iv day 1 of each course
16273071|NCT00841945|Drug|vincristine|VINCRISTINE 1?4 MG/M² IV ON DAY 1
16273072|NCT00841945|Drug|prednisone|Prednisone 40 mg/m² DAy 1 to day 5
16273073|NCT00841945|Procedure|radiotherapy|radiotherapy : total dose = 40 GY (5 fractions by week)
16273074|NCT00841932|Procedure|Fractional Flow Reserve|Fractional Flow Reserve performed without anticoagulation
16273075|NCT00841919|Drug|Glargine insulin|"The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff."
16273076|NCT00841919|Drug|NPH insulin and regular insulin|"The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff."
16273077|NCT00841919|Drug|lispro insulin|"Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of insulin pen/syringe on the food tray) by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the Inpatient Diabetes Advisory Group and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff."
16273078|NCT00841906|Device|Alice PDx with only written instructions|Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
16273079|NCT00841906|Device|Alice PDx with written and verbal instructions|Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
16273080|NCT00841893|Dietary Supplement|Mustard (dijon)|The specific spice added to a brunch meal
16273081|NCT00841893|Dietary Supplement|Placebo|Placebo added to a brunch meal
16273082|NCT00841880|Drug|Ramipril + Felodipine|Ramipril 5mg + Felodipine 5mg once a day
16273083|NCT00841880|Drug|Ramipril|10 mg once a day
16273084|NCT00841880|Drug|Ramipril|5mg once a day
16273085|NCT00841867|Procedure|All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.|All subjects will ingest a 75 g glucose solution (Glucola brand) and have blood drawn at 7 timepoints over 120 minutes.
16273086|NCT00841854|Drug|pantoprazole|pantoprazole 40mg bid
16273087|NCT00841854|Drug|bismuth|bismuth 300mg qid
16273088|NCT00841854|Drug|metronidazole|metronidazole 500mg tid
16273089|NCT00841854|Drug|tetracycline|tetracycline 500mg qid
16273090|NCT00841841|Drug|dipyrone and acetaminophen|The patients were randomly assigned to 2 groups of 15 patients, according to the drug prescribed as postoperative medication: Group I: dipyrone 500 mg every 6 hours (4 males, 11 females, mean age = 25.2 years) and Group II: paracetamol 750 mg every 6 hours (3 males, 12 females, mean age = 26.8 years)
16273091|NCT00841828|Drug|Epirubicin|
16273092|NCT00841828|Drug|Cyclophosphamide|
16273093|NCT00841828|Drug|Docetaxel|
16273094|NCT00841828|Drug|Lapatinib|
16273095|NCT00841828|Drug|Trastuzumab|
16273096|NCT00841815|Drug|Amlodipine Besylate|10 mg Tablet
16273097|NCT00841815|Drug|Norvasc®|10 mg Tablet
16273098|NCT00841802|Drug|Prednisone|Prednisone 30mg once daily x 5 days
16273099|NCT00841789|Drug|Etanercept|etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
16273100|NCT00841789|Drug|Placebo|Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
16273101|NCT00841776|Drug|Duac|Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
16273102|NCT00841776|Drug|Ziana gel|Clindamycin and tretinoin gel once a day for 12 weeks.
16273103|NCT00841763|Biological|Placebo (PL)|One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.
16273104|NCT00841763|Biological|Trivalent influenza virus vaccine (TIV)|A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.
16273105|NCT00841763|Biological|Adjuvanted monovalent influenza virus vaccine (aH5N1)|Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.
16273106|NCT00841763|Biological|Adjuvanted trivalent influenza virus vaccine (aTIV)|Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.
16273107|NCT00841750|Procedure|Do not leave a chest tube in the pleural cavity.|At the end of a VATS wedge resection, an air leak proof will take place and if no air leak is noted, the surgical incisions for thoracoscopy ports will be closed without leaving a chest tube inserted in the pleural cavity of the patient.
16273108|NCT00841750|Procedure|Do leave a chest tube in the pleural cavity.|At the end of a VATS wedge resection, a chest tube will be inserted in the pleural cavity of the patient through the inferior surgical incision for thoracoscopy port; the rest of the incisions will be closed.
16273109|NCT00841737|Other|Psychoeducational group|The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
16273110|NCT00841737|Other|Control Group|In the control group the depression is treated as usual with the conventional treatment.
16273111|NCT00841724|Drug|Fludarabine, Busulfan, Thymoglobuline|
16273112|NCT00841711|Behavioral|Intensive Case Management|Transitions involves the integration of evidence-based interventions, intensive case management that incorporates outreach elements similar to assertive community treatment (ACT). Intensive case management goes beyond the tenets of case management and incorporates community outreach. This model of case management has its roots in assertive community treatment (ACT) and has demonstrated a 37% greater reduction in homelessness and a 26% greater improvement in psychiatric symptom severity compared with standard case management treatments. As such, intensive case management is likely to result in important outcomes for the target population, is evidence-based and has been validated in prison-release programs.
16273113|NCT00841698|Drug|Paroxetine HCl|40 mg Film-Coated Tablet
16273114|NCT00841698|Drug|Paxil®|40 mg Film-Coated Tablet
16273115|NCT00841685|Device|Goldlock|Insertion of Goldlock marker
16273116|NCT00841685|Device|Visicoil smallest size|Insertion of Visicoil, smallest size, marker
16273117|NCT00841685|Device|Visicoil larger size|Insertion of Visicoil, larger size, marker
16273118|NCT00841685|Device|Bard goldmarker smallest size|Insertion of Bard goldmarker, smallest size
16273119|NCT00841685|Device|Bard goldmarker larger size|Insertion of Bard goldmarker, larger size
16273120|NCT00841672|Drug|Aliskiren/amlodipine 300/10 mg tablet|Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
16273121|NCT00841672|Drug|Amlodipine 10 mg capsule|Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
16273122|NCT00841659|Drug|Paroxetine HCl|40 mg Film-Coated Tablet
16273123|NCT00841659|Drug|Paxil®|40 mg Film-Coated Tablet
16273124|NCT00841646|Biological|Monovalent inactivated influenza vaccine|2 doses of monovalent inactivated influenza vaccine with adjuvant
16273125|NCT00841633|Drug|Induced hypertension with norepinephrine|Hypertension will be induced with norepinephrine. Administration of norepinephrine results in vasoconstriction, leading to an increase in blood pressure. The normal blood pressure of the patient will be calculated as the average MAP of the day before the start of the study. To achieve the intended hypertension (30 mmHg above the normal MAP for patients allocated to index group 2) in most cases a dose of 100-300 ng/kg/minute must be administered. Norepinephrine will be started on a dose of 100 ng/kg/minute, after which the dosing will be adjusted to achieve the desired blood pressure level. The maximum dose to be used in the study is 1000 ng/kg/minute. Norepinephrine is administered through the central venous catheter.
16273126|NCT00841620|Procedure|Haemorrhoidectomy a.m. Milligan|Surgery
16273127|NCT00841620|Procedure|Stapled anopexy|Surgery
16273129|NCT00841594|Drug|nitroglycerin 0.9 % (MXQ-503)|MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
16273130|NCT00841594|Drug|Nitroglycerin ointment 2%, USP|MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
16273131|NCT00841581|Drug|Ranibizumab|Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.
16273132|NCT00841568|Drug|OPC-41061|orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
16273133|NCT00841555|Drug|temozolomide|"Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.
~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment"
16273134|NCT00841555|Radiation|Hypofractionated radiation therapy|Patients will undergo HIMRT
16273135|NCT00841555|Radiation|Intensity-modulated radiation therapy|Patients undergo HIMRT
16273136|NCT00841542|Drug|Amlodipine Besylate|10 mg Tablet
16273137|NCT00841542|Drug|Norvasc®|10 mg Tablet
16273138|NCT00841529|Device|Medtronic LAA Occlusion Device|Placement of the occlusion band on the LAA
16273139|NCT00841516|Other|Placebo|Placebo was given the same way as a subcutaneous (just under the skin) injection.
16273140|NCT00841516|Biological|rBet v1-FV|Placebo was given the same way as a subcutaneous (just under the skin) injection.
16273141|NCT00841503|Other|buckwheat, rice crackers, glucose, sugar substitute|crackers contain equal amounts of available carbohydrates; 50 mls of oral solution for both glucose and Splenda
16273142|NCT00841477|Biological|hepatitis B vaccine 3 dose schedule (0,1,2 month)|hepatitis B (HB) vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated HB vaccine schedule (0,1,2 month),vs, standard HB vaccine schedule (0,1,6 m)
16273143|NCT00841477|Behavioral|HBV Vaccination Self-Efficacy Intervention|HB Vaccination Intervention consists of 4 sessions - Sessions 1, 2: at screening and enrollment after intake, vs regular risk reduction education Sessions 3, 4: coincide with the vaccination schedule ions 4 before 3rd dose
16273144|NCT00841451|Drug|Lovaza (Fish Oils)|Double blinded placebo controlled
16273145|NCT00841438|Drug|Clotinab|Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg
16273146|NCT00841438|Drug|Clotinab|Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg
16273147|NCT00841412|Behavioral|Immediate Intervention Group|Unit staff received weekly training and feedback for 12-weeks to improve daily nutritional care processes.
16273148|NCT00841412|Behavioral|Delayed Intervention Group|Research staff monitored this group under usual care conditions, then these units crossed over into intervention.
16273149|NCT00841399|Biological|E75 + GM-CSF vaccine|Dose escalation scheme involving three patients each receiving injection of 100, 500, or 1,000 mcg E75 + GM-CSF monthly for 6 months. HLA-A2 and HLA-A3 status determined. HLA-A2+ and HLA-A3+ patients receive the vaccine; HLA-A2- and HLA-A3- enrolled to the control arm.
16273150|NCT00841386|Drug|Riboflavin-5-phosphate|Riboflavin 0.1% (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container) will be applied to the cornea every 2-3 minutes for 15 minutes prior to starting UV irradiation. The UV irradiation will be given in six 5 minute intervals. Additional riboflavin will be administered following each 5 minute UV treatment.
16273151|NCT00841386|Drug|Sham cross-linking|Topical anesthesia (lidocaine jelly 2%) will be used. Differing from the treatment group, no epithelium will be debrided, but instead, this step will be skipped and 2% methylcellulose solution with 1% sodium fluorescein will be applied to the cornea every 5 minutes for 15 minutes, and then every 5 minutes during the sham UV treatment. The patient will be placed under the UV device, and the aiming beam applied.
16273152|NCT00841373|Procedure|Panretinal Photocoagulation|Panretinal Photocoagulation treatment
16273153|NCT00841373|Procedure|Panretinal Photocoagulation and intravitreal injection of ranibizumab|Panretinal photocoagulation and ranibizumab
16273154|NCT00841360|Other|Index Recruiter|Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
16273155|NCT00841360|Other|Friendship Network Member|Participants are recruited by Index Recruiters to enroll in study and receive HIV screening and complete a questionnaire either on Facilitators of HIV Screening or Barriers to HIV Screening.
16273156|NCT00841347|Behavioral|habitual sleep length period + extended sleep length period|On obese group, realisation of an habitual sleep length period followed by an extended sleep length period
16273157|NCT00841347|Behavioral|extended sleep length period + habitual sleep length period|On obese group, realisation of an extended sleep length period followed by an habitual sleep length period
16273158|NCT00841334|Behavioral|ACTION|Overweight/obese adolescents enrolled in ACTION will meet with SBHC providers over a 6 month period in one school year. SBHC providers will use Motivational Enhancement Therapy to motivate overweight/obese adolescents to adopt strategies for improving nutrition and physical activity.
16273159|NCT00841334|Behavioral|Usual care|Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.
16273160|NCT00841321|Drug|Ginkgo biloba|120 mg orally twice a day for 12 weeks
16273161|NCT00841321|Drug|Placebo|One capsule orally twice a day for 12 weeks
16273162|NCT00841308|Other|Decision to start and titrate drug treatment based only on home blood pressure monitoring|"Drug Treatment according to current Hypertension Guidelines. Decision to start and titrate drug treatment based on clinic and ambulatory blood pressure (Usual care arm) versus based on home blood pressure monitoring only (Home blood pressure monitoring arm)."
16273163|NCT00841295|Drug|Parenteral L-carnitine supplementation|Parenteral carnitine supplementation (9 ± 1 mg/kg/d), from day 4, until than enteral nutrition provides sufficient carnitine source.
16273164|NCT00841295|Drug|Parenteral supplementation with sterile water|Parenteral supplementation with an equivalent volume of sterile water
16273165|NCT00841282|Procedure|Colonoscopy for colorectal cancer screening|
16273166|NCT00841282|Procedure|Water Infusion Colonoscopy|water infusion in lieu of air insufflation for screening colonoscopy
16273167|NCT00841282|Procedure|Air insufflation colonoscopy|Conventional colonoscopy with air insufflation
16273168|NCT00841269|Drug|Uridine|Uridine 500 mg by mouth twice per day for 6 weeks
16273169|NCT00841256|Biological|Grass pollen allergens in a water/glycerol solution|In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
16273170|NCT00841256|Drug|Placebo|Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
16273171|NCT00841243|Dietary Supplement|Nutrison (Nutricia)|During 48 weeks of treatment, the patient will receive at T=0, 2, 4, 8, 12, 18, 24, 36, 48 weeks dietary advise combined with daily nutritional support in the form of a nutritional supplement drink at bedtime.
16273172|NCT00841230|Drug|Deanxit|Deanxit 1x/day
16273173|NCT00841230|Drug|Lactose placebo|Lactose used as placebo
16273174|NCT00841217|Drug|GW501516|2.5mg/day
16273175|NCT00841217|Drug|placebo pill|
16273176|NCT00841204|Drug|sulindac|Given orally
16273177|NCT00841204|Other|placebo|Inactive agent
16273178|NCT00841204|Other|laboratory biomarker analysis|Correlative studies
16273179|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 2.8 milligram per kilogram (mg/kg) will be administered as 1-hour intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1, Day 28, Day 42 and Day 56
16273180|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 5.5 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 42 and Day 56
16273181|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 11 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 49 and Day 70
16273182|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion on Day 1, Day 28, Day 49 and Day 70
16273183|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days
16273184|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days to participants with ovarian cancer.
16273185|NCT00841191|Drug|CNTO 328; Anti-interleukin-6 monoclonal antibody|Siltuximab 15 mg/kg will be administered as 1-hour intravenous infusion once every 21 days for up to a total of 231 days to participants with tumors harboring Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations or pancreatic cancer, or non-small cell lung cancer (NSCLC), colorectal cancer (CRC), or head and neck (H&N) cancer that were refractory or resistant to anti-epidermal growth factor receptor (EGFR) therapy
16273186|NCT00841178|Procedure|Surgery|Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
16273187|NCT00841178|Procedure|EVLT|EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
16273188|NCT00841165|Device|Continuous Positive Airway Pressure|Full face CPAP at 5cm H2O and 100% oxygen
16273189|NCT00841165|Device|Non-rebreather oxygen mask|Oxygen administered through a non-rebreather mask
16273190|NCT00841152|Device|Bioactive glass|Surgical implantation
16273191|NCT00841152|Device|Beta-tricalcium phosphate (ChronOs)|Surgical implantation
16273192|NCT00841152|Procedure|Autograft|Surgical transplantation from iliac crest
16273193|NCT00841152|Procedure|Allograft (frozen femoral head)|Surgical transplantation
16273194|NCT00841139|Drug|Perhexiline|100mg o bd
16273195|NCT00841139|Drug|Placebo|1 tablet bd
16273196|NCT00841126|Drug|Magnesium iron hydroxycarbonate|500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.
16273197|NCT00841126|Drug|Lanthanum carbonate|750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.
16273198|NCT00841126|Drug|Placebo|0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.
16273199|NCT00841113|Drug|Abarelix|100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
16273200|NCT00841113|Drug|Goserelin plus Bicalutamide|Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
16273201|NCT00841100|Drug|Kuvan|20mg/kg by mouth once daily
16273202|NCT00841100|Other|Diet|Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.
16273203|NCT00841087|Drug|insulin degludec|The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime
16273204|NCT00841087|Drug|insulin detemir|Injection subcutaneously at bedtime
16273205|NCT00841087|Drug|insulin aspart|Injection subcutaneously immediately before each meal.
16273206|NCT00841074|Drug|chlorhexidine|0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
16273207|NCT00841074|Drug|Placebo mouthwash|Placebo mouthwash spray application of ~1.3 ml twice a day.
16273208|NCT00841061|Dietary Supplement|electrolytic iron|1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age
16273209|NCT00841061|Dietary Supplement|ferrous fumarate|1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age
16273210|NCT00841048|Drug|AZD4017|ascending multiple doses(start dose 75mg od), oral suspension
16273211|NCT00841048|Drug|Placebo|
16273212|NCT00841035|Drug|erlotinib|Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib 100 mg daily 6 month/6 chemotherapy cycles. Gemcitabine 1000 m2 weekly after surgery for 6 cycles.
16273213|NCT00841022|Other|Information with comics|Information of children with comic leaflet
16273214|NCT00840996|Drug|Lidocaine|perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
16273355|NCT00839813|Behavioral|Yoga|10 weeks of a trauma-sensitive yoga class
16273215|NCT00840996|Drug|placebo|perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
16273216|NCT00840983|Procedure|delayed cord clamping|cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
16273217|NCT00840970|Device|non-coated Intranasal Splint|placement of non-coated intranasal splint following FESS
16273218|NCT00840970|Device|Sinexus Intranasal Splint|placement of Sinexus Intranasal Splint placed following FESS
16273219|NCT00840957|Biological|infliximab|chimeric monoclonal antibody to Tumor Necrosis Factor-alpha
16273220|NCT00840944|Drug|somatropin|somatropin 0.050 mg/kg/day
16273221|NCT00840944|Drug|triptorelin|triptorelin 3.75 mg each month
16273222|NCT00840931|Drug|lenalidomide|Patients will take 10 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Patients will receive 4 treatment cycles with 28 days in each cycle.
16273223|NCT00840931|Biological|bystander vaccine|In addition to lenalidomide, during each 28 day cycle patients will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.
16273224|NCT00840918|Drug|Lidocaine|Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
16273225|NCT00840918|Other|Placebo|Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
16273226|NCT00840892|Other|INTERdisciplinary COMmunity-based COPD management (INTERCOM)|The INTERCOM program consisted of exercise training, education, nutritional therapy and smoking cessation support offered by local physiotherapists and dieticians in the proximity of the patient's home and by respiratory nurses in the hospital. The program was divided in a 4-month intensive intervention phase, followed by a 20-month maintenance phase.
16273227|NCT00840879|Drug|Meloxicam 15 mg Tablets|1 x 15 mg, single-dose fed
16273228|NCT00840879|Drug|Mobic® 15 mg Tablets|1 x 15 mg, single-dose fed
16273229|NCT00840866|Drug|cefprozil|500 mg Tablet
16273230|NCT00840866|Drug|Cefzil®|500 mg Tablet
16273231|NCT00840853|Genetic|CD19CAR/virus specific T cells|CD19CAR/virus specific T cells will be thawed and given by intravenous injection from day +30 post transplant.
16273232|NCT00840853|Drug|Benadryl and Tylenol|Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.
16273233|NCT00840840|Drug|600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL|1 x 600 mg/42.9 mg/5 mL, single-dose fasting
16273234|NCT00840840|Drug|Augmentin ES-600™|1 x 600 mg/42.9 mg/5 mL, single-dose fasting
16273235|NCT00840827|Drug|lenalidomide|Lenalidomide 10mg po daily
16273236|NCT00840827|Drug|cyclosporine A|CSA 250mg orally twice daily
16273237|NCT00840801|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
16273238|NCT00840801|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
16273239|NCT00840788|Procedure|octyl-2-cyanoacrylate adhesive glue|use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
16273240|NCT00840788|Procedure|Subcuticular suture of perineal skin|Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair
16273241|NCT00840775|Device|Catheterization, stent deployment|Standard catheterization procedure including Bare Metal Stent deployment.
16273242|NCT00840762|Other|VircoType HIV-1 genotypic interpretation|VircoType HIV-1 genotypic interpretation
16273243|NCT00840762|Other|Local Expert Review of HIV Genotypic resistance testing|Local Expert Review of HIV Genotypic resistance testing
16273244|NCT00840749|Radiation|CyberKnife Stereotactic Radiotherapy|Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
16273245|NCT00840749|Procedure|Surgery|Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
16273246|NCT00840736|Procedure|Laparoscopic adjustable gastric banding|Laparoscopic adjustable gastric banding
16273247|NCT00840736|Procedure|vertical banded gastroplasty|vertical banded gastroplasty
16273248|NCT00840697|Behavioral|Exercises and work related rehabilitation|Treatment in groups, twice a week for 3 weeks. The treatment includes exercises, cognitive intervention and work related rehabilitation. The exercises include fitness, strength and stretching
16273249|NCT00840697|Behavioral|Brief intervention|1 consultation at the physiotherapist, which give advice Summary talk with the physician about activity and work when having neck- and low back pain
16273250|NCT00840697|Behavioral|multidisciplinary exercise group|10 days during 3 weeks. Treatment in groups, exercise and cognitive treatment
16273251|NCT00840684|Drug|amsacrine|
16273252|NCT00840684|Drug|busulfan|
16273253|NCT00840684|Drug|cytarabine|
16273254|NCT00840684|Drug|daunorubicin hydrochloride|
16273255|NCT00840684|Drug|laromustine|
16273256|NCT00840684|Drug|melphalan|
16273257|NCT00840684|Drug|mitoxantrone hydrochloride|
16273258|NCT00840684|Procedure|allogeneic hematopoietic stem cell transplantation|
16273259|NCT00840684|Procedure|autologous hematopoietic stem cell transplantation|
16273260|NCT00840671|Drug|Cerebrolysin|Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
16273261|NCT00840671|Drug|0.9% Saline Solution|0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
16273356|NCT00839800|Drug|Symbicort Turbuhaler|160/4.5 µg
16273357|NCT00839800|Drug|Terbutaline Turbuhaler|0.4 mg
16273358|NCT00839787|Drug|Morphine Sulfate|Morphine Sulfate group: If weight is <50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given
16273359|NCT00839774|Other|Whole yellow pea flour|Whole pea flour was administered at 50 g/day.
16273262|NCT00840658|Behavioral|Interactive injection and sexual risk intervention|This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
16273263|NCT00840658|Behavioral|Interactive Sexual Risk Intervention|This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
16273264|NCT00840658|Behavioral|Interactive Injection Risk Intervention|This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
16273265|NCT00840658|Behavioral|Lecture-format presentation|60 minute lecture-format presentation on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). There are no theory-driven active skill building elements oriented towards safer sex or safer injection.
16273266|NCT00840645|Drug|YM178|Oral
16273267|NCT00840632|Drug|Trandolapril 4 mg Tablets|1 x 4 mg, single-dose fasting
16273268|NCT00840632|Drug|Mavik® 4 mg Tablets|1 x 4 mg, single-dose fasting
16273269|NCT00840606|Drug|BUSPAR® 30 mg Tablet|1 x 30 mg, single-dose fasting
16273270|NCT00840606|Drug|Buspirone Hydrochloride 30 mg Tablet|1 x 30 mg, single-dose fasting
16273271|NCT00840593|Procedure|Non-surgical group|The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.
16273272|NCT00840593|Procedure|Surgical group|The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.
16273273|NCT00840580|Drug|Moxifloxacin 0.5% ophthalmic solution (Vigamox)|One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
16273274|NCT00840580|Drug|Levofloxacin 0.5% ophthalmic solution (Cravit)|One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
16273275|NCT00840567|Procedure|Skin biopsy|
16273276|NCT00840567|Procedure|Blood draw & sample|
16273277|NCT00840554|Other|Clinic-based physical therapy program.|All patients will receive a routine clinic-based physical therapy program. This program may include supervised aerobic conditioning, strengthening exercise, balance retraining, functional activity training, therapeutic exercise, and manual therapy.
16273278|NCT00840554|Other|Home exercise program.|In addition to the clinic-based physical therapy program, patients will perform home exercises. Home exercise will include a walking and strengthening program 5 days per week. The home exercise routine will be recorded in an exercise diary.
16273279|NCT00840528|Other|ozone|0.4 ppm ozone for 2 hours
16273280|NCT00840489|Drug|Ribavirin|Ribavirin 1000-1200 mg qd for 24 weeks
16273281|NCT00840489|Drug|Colchicine|Colchicine 0.5 mg bd for 24 weeks
16273282|NCT00840476|Drug|Meloxicam 15 mg Tablets|1 x 15 mg, single-dose fasting
16273283|NCT00840476|Drug|Mobic® 15 mg Tablets|1 x 15 mg, single-dose fasting
16273284|NCT00840463|Drug|Ambrisentan|Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
16273285|NCT00840463|Other|Placebo|Sugar pill
16273286|NCT00840450|Drug|Gleevec/Paclitaxel|"One treatment cycle:
~Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days.
~Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days.
~After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression."
16273287|NCT00840411|Drug|Clarithromycin ER 500 mg tablets|1 x 500 mg
16273288|NCT00840411|Drug|BIAXIN® XL 500 mg tablets|1 x 500 mg
16273289|NCT00840398|Drug|BUSPAR® 30 mg Tablet|1 x 30 mg, single-dose fed
16273290|NCT00840398|Drug|Buspirone Hydrochloride 30 mg Tablet|1 x 30 mg, single-dose fed
16273291|NCT00840385|Drug|FAD|Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.
16273292|NCT00840372|Procedure|Buttonhole cannulation with semi-blunt needles|Use of semi-blunt needles, compared to blunt needles, at every dialysis session
16273293|NCT00840359|Procedure|Photodynamic therapy|Application of Metvix 16% cream followed by exposure to daylight for 2.5 hours
16273294|NCT00840359|Procedure|Cryotherapy|Cryotherapy for 2 times 20 sec
16273295|NCT00840346|Drug|panobinostat|20 mg, 30 mg, 40 mg in combination with idarubicin and cytarabine, according to the classical 3+3 schedule.
16273296|NCT00840333|Drug|MP-376 (Levofloxacin solution for Inhalation)|DOSE BASED ON PATIENTS WEIGHT
16273297|NCT00840320|Drug|1278863|15mg, 25mg, 50mg, 150mg
16273298|NCT00840320|Drug|Placebo|matching placebo
16273299|NCT00840294|Drug|Ciprofloxacin|
16273300|NCT00840281|Drug|Cefzil® 500 mg tablets|1 x 500 mg, single-dose fasting
16273301|NCT00840281|Drug|Cefprozil 500 mg Tablets|1 x 500 mg, single-dose fasting
16273302|NCT00840268|Drug|Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel|
16273303|NCT00840268|Drug|Hydroxypropyl Guar Galactomannan Vehicle|Inactive ingredients used as a placebo comparator
16273304|NCT00840255|Behavioral|BBTI-MV|Twenty participants will be randomized to BBTI-MV. As previously described, the intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3, and telephone appointments on Weeks 2 and 4. Interventions will be delivered at Western Psychiatric Institutes and Clinic. If possible, (according to space availability), the face-to-face sessions may also be conducted at the VAPHS clinics or at Reserve and Veterans Centers locally and regionally to strengthen our relations with local care and services providers and centers, and to facilitate future collaborative efforts. The duration of the first treatment visit is 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
16273305|NCT00840255|Other|Information Control|Participants will receive two brochures from the American Academy on Sleep Medicine of Sleep Hygiene and on Insomnia. The therapists will read the content of the 2 brochures with participants, and discuss how the information provide relates to individual participants' sleep experiences. No recommendations for altering sleep schedules will be made by the assigned therapist. Participants will be instructed to read these two brochures over the course of the following week, and to consider how the information provided in the brochures related to their own sleep patterns
16273306|NCT00840242|Drug|Nicotine gum|8-12 pieces per day, maximum 24 daily
16273307|NCT00840242|Drug|Placebo gum|8-12 pieces per day, maximum 24 daily
16273308|NCT00840242|Drug|Nicotine inhaler|6-12 cartridges per day, maximum 12 daily
16273309|NCT00840242|Drug|Placebo inhaler|6-12 cartridges per day, maximum 12 daily
16273310|NCT00840229|Drug|Triamcinolone hexacetonide|20 mg
16273311|NCT00840229|Drug|Triamcinolone hexacetonide|1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
16273312|NCT00840216|Drug|Clarithromycin ER 500 mg tablets|1 x 500 mg
16273313|NCT00840216|Drug|BIAXIN® XL 500 mg tablets|1 x 500 mg
16273314|NCT00840203|Drug|Rowasa® 4 gm/60 mL Rectal Enema|1 x 4 gm/60 mL, single-dose
16273315|NCT00840203|Drug|Mesalamine 4 gm/60 mL Rectal Enema|1 x 4 gm/60 mL, single-dose
16273316|NCT00840190|Drug|P1446A-05|P1446A-05 available as 25mg,50mg,100mg capsule. Subjects will be enrolled at at different dose levels of P1446A-05 to be taken once a day for 14 days followed by 7 days rest.This constitutes one cycle of P1446A-05. Four such cycles will be administered.
16273317|NCT00840177|Drug|cytarabine|1.5 g/m2/day given by continuous IV on days 4-7
16273318|NCT00840177|Drug|idarubicin|12 mg/m2/day given intravenously over 10-15 minutes on days 4-6
16273319|NCT00840177|Drug|pravastatin sodium|1,280 mg/day given orally on days 1-8
16273320|NCT00840151|Behavioral|contingency management|Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.
16273321|NCT00840138|Procedure|Surgical reconstruction|"Hepaticojejunostomy
~End-to-end anastomosis
~Duct suture over T-tube"
16273322|NCT00840125|Drug|erlotinib|150mg tablet daily
16273323|NCT00840125|Drug|docetaxel|30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles
16273324|NCT00840112|Dietary Supplement|Vitamin E supplement|400 IU (268 mg) capsules of will be provided for the subjects. Subjects will be instructed to take one capsule with meals 2 times per day.
16273325|NCT00840099|Drug|600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL|1 x 600 mg/42.9 mg/5 mL, single-dose fed
16273326|NCT00840099|Drug|Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension|1 x 600 mg/42.9 mg/5 mL, single-dose fed
16273327|NCT00840086|Drug|turoctocog alfa|Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
16273328|NCT00840073|Drug|Trandolapril 4 mg Tablets|1 x 4 mg, single-dose fed
16273329|NCT00840073|Drug|Mavik® 4 mg Tablets|1 x 4 mg, single-dose fed
16273330|NCT00840060|Behavioral|AMALS|Addressing multiple aspects of language simultaneously
16273331|NCT00840060|Behavioral|DTA|Discrete Trial Approach
16273332|NCT00840047|Drug|Methionine|Intravenous injection
16273333|NCT00840034|Drug|LY2216684|Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.
16273334|NCT00840034|Drug|Placebo|3 tablets PO QD for up to 12 weeks
16273335|NCT00840008|Other|Educational intervention|As per detailed protocol.
16273336|NCT00839982|Drug|clofarabine|Given PO
16273337|NCT00839982|Drug|cytarabine|Given SC
16273338|NCT00839969|Procedure|Cystoscopy|Saline cystoscopy under general anaesthesia
16273339|NCT00839969|Procedure|Cystoscopy and urethral dilatation|Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia
16273340|NCT00839956|Drug|Bortezomib|Given IV
16273341|NCT00839956|Drug|Vorinostat|Given PO
16273342|NCT00839943|Other|ozone, 0.4 ppm|2 hour ozone exposure, 0.40 ppm
16273343|NCT00839930|Drug|Cilostazol 50 mg Tablets|1 x 50 mg, single-dose fasting
16273344|NCT00839930|Drug|Pletal®|1 x 50 mg, single-dose tablet
16273345|NCT00839917|Biological|Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)|Single administration of 0.5 mL subcutaneous injection
16273346|NCT00839917|Biological|M-M-R™ II and Varivax™|Single administration of 0.5 mL subcutaneous injection
16273347|NCT00839904|Behavioral|exercise|two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
16273348|NCT00839891|Drug|VI-0521|PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)
16273349|NCT00839878|Other|No treatment given|Subject will only fill out a questionaire when entering the observational study.
16273350|NCT00839865|Drug|herb ointment|a kind of ointment made from herb
16273351|NCT00839852|Drug|Cariprazine|Cariprazine was supplied in capsules.
16273352|NCT00839839|Procedure|Oocyte Vitrification|All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.
16273353|NCT00839826|Drug|Rivaroxaban (BAY59-7939)|2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial
16273354|NCT00839826|Drug|Enoxaparin|40 mg bid
16273360|NCT00839774|Other|Fractionated pea flour|Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day
16273361|NCT00839774|Other|White wheat flour|White wheat flour will be administered at 50 g/day
16273362|NCT00839761|Dietary Supplement|iron fortified rice|
16273363|NCT00839761|Dietary Supplement|iron drops|
16273364|NCT00839722|Procedure|embolization|fertility after embolization
16273365|NCT00839709|Procedure|blood sampling|peripheral blood draw
16273366|NCT00839683|Drug|simvastatin|Tablets, Oral, 20 mg, Single Dose
16273367|NCT00839683|Drug|Dapagliflozin|Tablets, Oral, 20 mg, Single Dose
16273368|NCT00839683|Drug|simvastatin|Oral, 40 mg, Single Dose
16273369|NCT00839683|Drug|valsartan|Tablets, Oral, 320 mg, Single Dose
16273370|NCT00839670|Other|Light constraint induced therapy|90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
16273371|NCT00839670|Other|Standard constraint induced therapy|360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
16273372|NCT00839657|Behavioral|Genotype-guided dosing algorithm for warfarin|Initial dosing of warfarin for the first 3-4 days of treatment will be determined by an algorithm that uses clinical and genetic information. Following this initiation dose of warfarin, a second dose adjustment will be made after 3 and/or 4 doses of warfarin using a dose revision algorithm that incorporates the clinical and genetic information.
16273373|NCT00839657|Behavioral|Clinical-guided dosing algorithm for warfarin|Initial dosing of warfarin for the first 3-4 days of treatment will be determined by an algorithm that uses clinical information. Following this initiation dose of warfarin, a second dose adjustment will be made after 3 and/or 4 doses of warfarin using a dose revision algorithm that incorporates the clinical information.
16273374|NCT00839644|Device|High frequency chest wall oscillation|Therapy prescribed twce daily for twenty minute sessions. High frequency chest wall oscillation (HFCWO) applies sharp compression pulses via an air-pulse generator and inflatable vest. HFCWO generates transient increases in airflow at low lung volumes, cough-like shear forces, and alterations in the consistency of secretions.
16273375|NCT00839644|Device|Oscillatory Positive Expiratory Pressure|Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.
16273376|NCT00839644|Other|PD&P: Postural drainage and percussion|Each of the six positions are to be clapped or vibrated for 4 minutes. After each position the patient is to do three forced expiratory techniques (FET) and cough, continue with FET and coughing until all mobilized mucus has been cleared.
16273377|NCT00839631|Drug|EC D-3263 HCl|EC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing.
16273378|NCT00839605|Drug|Dexmedetomidine|loading dose:0.3mcg/kg. Infusion of 0.3mcg/kg/hr
16273379|NCT00839592|Other|Electroacupuncture|Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
16273380|NCT00839579|Other|1x4 min interval|Aerobic interval training
16273381|NCT00839566|Procedure|Ablation|AV-node ablation
16273382|NCT00839566|Other|Rate Control|Rate control by drug
16273383|NCT00839553|Procedure|Intrapleural Minocycline application|
16273384|NCT00839540|Drug|micafungin|100 mg qd by slow IV infusion for 24 h
16273385|NCT00839540|Drug|Micafungin|200 mg qd by slow IV infusion for 24 h
16273386|NCT00839540|Drug|Caspofungin|70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
16273387|NCT00839527|Drug|placebo to match albiglutide|albiglutide matching placebo weekly subcutaneous injection
16273388|NCT00839527|Biological|albiglutide|albiglutide weekly subcutaneous injection
16273389|NCT00839527|Drug|metformin|metformin
16273390|NCT00839527|Drug|glimepiride|glimepiride
16273391|NCT00839527|Drug|pioglitazone|pioglitazone
16273392|NCT00839527|Drug|placebo to match pioglitazone|pioglitazone matching placebo
16273393|NCT00839501|Dietary Supplement|Potassium|40 mEq twice daily in pill form during the first 3-day inpatient visit, followed by 40 mEq twice daily in liquid form during the first 18-week treatment period, as is randomly scheduled, and continued during the second 18-week treatment period as long as there are no limiting side effects
16273394|NCT00839501|Drug|Acetazolamide|250 mg twice daily, orally, during the second 3-day inpatient visit and during the second 18-week treatment period, as is randomly scheduled
16273395|NCT00839488|Drug|pantoprazole 40 mg iv|pnatoprazole 40 mg iv qd
16273396|NCT00839488|Drug|famotidine 20 mg iv|famotidine 20 mg q12h
16273397|NCT00839462|Drug|Dexpanthenol foam spray, new formulation|2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
16273398|NCT00839462|Drug|Dexpanthenol foam spray, old formulation|2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
16273399|NCT00839449|Drug|Eicosapentaenoic acid ethyl ester|Orally administered 900 mg eicosapentaenoic acid ethyl ester three times a day (2700 mg ⁄ day) from the surgery next day to 30 days after the onset of SAH.
16273400|NCT00839436|Drug|CYT107|
16273401|NCT00839423|Drug|Placebo|capsules, daily, orally
16273402|NCT00839423|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets, daily, orally
16273403|NCT00839423|Drug|Venlafaxine XL|capsules, daily, orally
16273469|NCT00838929|Drug|Vorinostat|"All doses given for 3 weeks
~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd"
16273470|NCT00838929|Radiation|Radiation Therapy|Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.
16273471|NCT00838916|Biological|albiglutide|albiglutide weekly injection
16273472|NCT00838916|Drug|insulin glargine|insulin glargine
16273404|NCT00839397|Drug|Paroxetine|"Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response (1. Very much improved or 2. Much improved based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted.
~Dosage adjustment will be made at the discretion of the PI or Sub-PI"
16273405|NCT00839384|Device|Advisa IPG|Implantable Pulse Generator will be implanted
16273406|NCT00839371|Drug|Propofol|i.v. propofol titration until adequate depth of sedation
16273407|NCT00839371|Drug|Midazolam|i.v. midazolam titration until adequate depth of sedation
16273408|NCT00839358|Drug|albumin|albumine 40 g every 15 days
16273409|NCT00839358|Drug|Midodrine|Midodrine 5mg/8 hs, can be increase up to 8mg/8hs if there is a lack of increase in at least 10mmHg in mean arterial pressure after 15 days of treatment.
16273410|NCT00839358|Drug|Placebo|saline solution
16273411|NCT00839345|Drug|clopidogrel|The intervention will involve the change of dosage or change of drug. The traditional maintenance dose of clopidogrel is 75 mg per day. We will test in non-responders to this classical dose higher doses up to 225mg per day. In patients,who will not respond to this 3times higher dose,clopidogrel will be replaced by ticlopidine.
16273412|NCT00839332|Drug|LY2603618|
16273413|NCT00839332|Drug|Gemcitabine|
16273414|NCT00839319|Drug|Acyline|300 ug/kg subcutaneous injections on Day 1.
16273415|NCT00839319|Other|placebo hCG (no active ingredient)|placebo hCG
16273416|NCT00839319|Drug|hCG (human chorionic gonadotropin)|15 IU subcutaneous injection every other day for 10 days (5 doses)
16273417|NCT00839319|Drug|hCG (human chorionic gonadotropin)|60 IU subcutaneous injection
16273418|NCT00839319|Drug|hCG (human chorionic gonadotropin)|125 IU subcutaneous injection
16273419|NCT00839319|Drug|Testosterone gel|75 mg testosterone gel applied transdermally for 10 days
16273420|NCT00839306|Drug|Rabeprazole ER|50 mg capsule, taken orally, once daily for 26 weeks.
16273421|NCT00839306|Drug|Ranitidine|150 mg capsule, taken orally, twice daily for 26 weeks.
16273422|NCT00839293|Drug|ABT-335|Once, see arm description for more information
16273423|NCT00839280|Drug|Dexpanthenol foam spray, new formulation|2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
16273424|NCT00839280|Drug|Dexpanthenol foam spray, old formulation|2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
16273425|NCT00839254|Biological|Pneumococcal conjugate vaccine Synflorix (GSK1024850A)|2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
16273426|NCT00839254|Biological|GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)|3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.
16273427|NCT00839254|Biological|GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)|2 Intramuscular injections only for children >= 12 months of age at the time of first study vaccination.
16273428|NCT00839241|Device|Bellovac ABT|Bellovac ABT (autologous blood)
16273429|NCT00839241|Procedure|Allogenic Blood Transfusion|"Transfusion of allogenic (bank) blood."
16273430|NCT00839228|Drug|Perhexiline|100mg o bd for 3 months
16273431|NCT00839228|Drug|Placebo|Placebo one tablet bd for 3 months
16273432|NCT00839202|Other|FVIII immuno-assay|There is no intervention. This is a study of the differences in assays.
16273433|NCT00839189|Biological|Clinical Center Reference Endotoxin (CCRE)|Inhalation of 10,000 EU CCRE
16273434|NCT00839176|Drug|RX-10100|Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
16273435|NCT00839163|Drug|Xarelto (Rivaroxaban, BAY59-7939)|10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
16273436|NCT00839163|Drug|Xarelto (Rivaroxaban, BAY59-7939)|20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
16273437|NCT00839163|Drug|Xarelto (Rivaroxaban, BAY59-7939)|30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
16273438|NCT00839163|Drug|Xarelto (Rivaroxaban, BAY59-7939)|40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
16273439|NCT00839163|Drug|Enoxaparin/Vitamin K-Antagonist|Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days
16273440|NCT00839124|Biological|Clinical Center Reference Endotoxin (CCRE)|inhalation challenge with 20,000 EU CCRE
16273441|NCT00839124|Biological|Clinical Center Reference Endotoxin (CCRE)|inhalation of 20,000 EU CCRE
16273442|NCT00839111|Drug|sorafenib|Sorafenib 400mg twice daily from d3 to d14,d17-28
16273443|NCT00839111|Drug|FOLFIRI|Irinotecan 180 mg/m2,CF 400mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
16273444|NCT00839098|Other|Instruction Group: Power seat function usage instruction- verbal and written instruction|Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the Veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions.
16273473|NCT00838903|Biological|albiglutide|albiglutide
16273474|NCT00838903|Drug|sitagliptin|sitagliptin
16273475|NCT00838903|Drug|glimepiride|Glimepiride
16273476|NCT00838903|Drug|metformin|Metformin
16273477|NCT00838903|Biological|placebo albiglutide|placebo to match albiglutide
16273445|NCT00839098|Other|Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach|Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance.
16273446|NCT00839085|Drug|GSE|grape seed extract (100 mg/6h), PO
16273447|NCT00839085|Drug|Vit C (Ascorbic Acid)|Vit C 25 mg/ kg
16273448|NCT00839072|Drug|Trazodone HCl|100 mg immediate-release tablet, dosing q8h
16273449|NCT00839072|Drug|Trazodone HCl|300 mg extended-release caplet, single dose
16273450|NCT00839059|Drug|lenalidomide|"Dose escalation:
~Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions.
~Duration of the first cycle: 56days, each following cycle will last 28 days"
16273451|NCT00839046|Behavioral|Community Health Worker Intervention|The Community Health Worker (CHW) intervention consists of visits by CHWS to help families reduce children's exposure to common asthma triggers (allergens and irritants) in the indoor environment. The content of the CHW visits and the materials distributed will follow NHLBI Expert Panel Report 2 recommendations. Each household will receive 6 visits over a 12-month period in which the CHW will provide education on environmental triggers (e.g., reduction of dust mites, cockroaches, cat and dog dander, and environmental tobacco smoke); materials including vacuum cleaners with HEPA filters, mattress and pillow covers, and cleaning supplies; social support to the caregivers; and, if indicated, referrals to other services.
16273452|NCT00839046|Other|Air Filter|Fifty households will receive an Air Filter, in addition to receiving the standard community health worker intervention. These households will receive a HEPA room AF (Whirlpool 510 or equivalent), a relatively high capacity unit that can be quietly operated. Similar to other studies the filter will be placed in the room where the child sleeps. The HEPA AF will be installed at the beginning of the intervention period.
16273453|NCT00839046|Other|Air Filter and Air Conditioner|Fifty households will receive the air filter and the air conditioner, in addition to receiving the standard community health worker intervention. The air filter will be installed at the beginning of the intervention, after baseline measurement. In the spring of the year (2009), a small window AC unit (Whirlpool Designer Style ACQ058MM or equivalent) will also be installed in the room where the child sleeps.
16273454|NCT00839033|Device|mechanical insufflation - exsufflation|Patients will receive MI-E treatment with the following settings: insufflation pressure of at least +30 cm H2O and an exsufflation pressure ≥ -30 cm H2O. There will be at least 6 hyperinflation/exsufflation sequences per session of chest physiotherapy. There will be at least two daily sessions done routinely by the respiratory therapist at 8 hour intervals.
16273455|NCT00839033|Device|Standard respiratory physiotherapy|Traditional chest physiotherapy without mechanical insufflation-exsufflation
16273456|NCT00839020|Procedure|Navigated TKA with a minimally invasive approach|Navigated total knee arthroplasty with a minimally invasive approach
16273457|NCT00839020|Procedure|Navigated TKA with a conventional approach|A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed
16273458|NCT00839007|Drug|CD-NP|Infusion of CD-NP at one of up to 6 doses or placebo
16273459|NCT00838994|Other|Acupuncture|Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
16273460|NCT00838981|Drug|Modafinil|Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.
16273461|NCT00838981|Drug|Sugar Pill|placebo, sugar pill will mirror active drug
16273462|NCT00838981|Behavioral|Contingency Management|Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.
16273463|NCT00838981|Drug|Methadone|Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.
16273464|NCT00838981|Behavioral|cognitive behavioral treatment|All subjects will receive a manual-guided CBT treatment over the course of their 16-week participation. This manual-guided therapy promotes abstinence through a functional analysis of high-risk situations and coping skills training.
16273465|NCT00838981|Behavioral|Voucher Control|Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth.
16273466|NCT00838968|Drug|interferon-alpha|interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months
16273467|NCT00838955|Drug|Temsirolimus|Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
16273468|NCT00838942|Behavioral|Questionaries|MMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles.
16273478|NCT00838903|Drug|placebo sitagliptin|placebo to match sitagliptin
16273480|NCT00838890|Drug|Cdc7-inhibitor (BMS-863233)|Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
16273481|NCT00838890|Drug|Cdc7-inhibitor (BMS-863233)|Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months
16273482|NCT00838877|Drug|radioligand [18F]AZD4694|single dose of iv. admin. 1-2 times per subject
16273483|NCT00838877|Drug|radioligand [11C]AZD2184|single dose of iv admin. 1 time per subject
16273484|NCT00838864|Drug|ceftrioxone|500 mg iv q12h for 3 days
16273485|NCT00838864|Drug|ceftrioxone|500 mg q12h for 7 days
16273486|NCT00838851|Biological|Clinical Center Reference Endotoxin (CCRE)|Inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE)
16273487|NCT00838838|Drug|Testosterone Undeconate (Nebido-R, BAY86-5037)|Male patients > 18yrs in medical practices fulfilling all criteria for documentation.
16273488|NCT00838825|Other|introduction of the chronic care model|The care management team is organized according to the chronic care model for health care delivery. They are supported by an information registry for diabetes, receive instruction in self-management, have redesigned their work flow to include delegation of functions to care managers who follow specific guidelines and protocols for managing diabetes
16273489|NCT00838812|Drug|application of the topic gel|Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.
16273490|NCT00838799|Drug|RGH-896|45 mg TID, capsules, 14 weeks.
16273491|NCT00838799|Drug|RGH-896|30 mg TID, capsules, 14 weeks.
16273492|NCT00838799|Drug|RGH-896|15 mg TID, capsules, 14 weeks.
16273493|NCT00838799|Drug|pregabalin|100 mg, TID, capsules, 14 weeks.
16273494|NCT00838799|Drug|placebo|TID, capsules, 14 weeks.
16273495|NCT00838773|Behavioral|YMSM|Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
16273496|NCT00838773|Behavioral|YHA|Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
16273497|NCT00838773|Behavioral|ROMA|Leaders of networks in the experimental condition will participate in a 9-session intervention training program that will inspire and assist leaders to communicate HIV prevention risk reduction messages with their immediate friends. The first five sessions will focus on HIV risk predictors including HIV/AIDS knowledge, safer sex peer norms, condom attitudes, condom use intentions, and self-efficacy in remaining safe. The remaining four sessions will reinforce the leaders for continuing their HIV prevention communications and remind them of the topics during the main sessions.
16273498|NCT00838760|Drug|TMC558445; TMC310911; Darunavir; Placebo|
16273499|NCT00838721|Other|laser trabeculoplasty|Deliver laser energy to the trabecular meshwork using the Pascal Laser System
16273500|NCT00838708|Drug|SRD174 Cream|topical SRD174 Cream
16273501|NCT00838708|Other|vehicle cream|topical vehicle cream
16273502|NCT00838695|Drug|Phenylephrine|Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)
16273503|NCT00838682|Drug|omeprazole sodium IV|Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
16273504|NCT00838682|Drug|Rabeprazole|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
16273505|NCT00838669|Drug|Extended release OROS paliperidone|
16273506|NCT00838656|Drug|carboplatin|Given IV in one of two schedules
16273507|NCT00838656|Drug|gemcitabine hydrochloride|Given IV in one of two schedules
16273508|NCT00838656|Drug|paclitaxel|Given IV in one of two schedules
16273509|NCT00838630|Drug|Cilostazol 100 mg tablets|1 x 100 mg
16273510|NCT00838630|Drug|Pletal® 100 mg tablets|1 x 100 mg
16273511|NCT00838591|Drug|MN-221|Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
16273512|NCT00838591|Drug|Placebo|
16273513|NCT00838578|Biological|KRN330|KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
16273514|NCT00838578|Drug|Irinotecan|Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
16273515|NCT00838565|Drug|Placebo|intravenous infusion on three consecutive months
16273516|NCT00838565|Drug|dose level 1|intravenous infusion on three consecutive months
16273517|NCT00838565|Drug|dose level 2|intravenous infusion on three consecutive months
16273518|NCT00838565|Drug|dose level 3|intravenous infusion on three consecutive months
16273519|NCT00838565|Drug|dose level 4|intravenous infusion on 3 consecutive months
16273520|NCT00838539|Drug|Neratinib|
16273521|NCT00838539|Drug|Temsirolimus|
16273522|NCT00838526|Drug|Rabeprazole ER|50 mg capsule, taken orally, once daily for 26 weeks.
16273523|NCT00838526|Drug|Ranitidine|150 mg capsule, taken orally, twice daily for 26 weeks.
16273524|NCT00838513|Drug|eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
16273566|NCT00838162|Drug|TMC310911 75 mg twice daily|TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.
16273567|NCT00838162|Drug|TMC310911 150 mg twice daily|TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14
16273525|NCT00838500|Drug|Immediate spa treatment|1st year, soon after randomization: Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts(walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower...)
16273526|NCT00838500|Drug|Late spa treatment|2nd year, soon after 12 months visit: Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts(walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower...)
16273527|NCT00838487|Other|condroflex and exercise|1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
16273528|NCT00838487|Other|sugar pill and exercise|1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
16273529|NCT00838474|Other|music|Each infant was randomized to receive music therapy or no music over 2 consecutive days
16273530|NCT00838461|Drug|HSD-016|
16273531|NCT00838461|Drug|placebo|
16273532|NCT00838448|Behavioral|Exercise|Exercise performed on a treadmill for 20-30 minutes
16273533|NCT00838435|Drug|sapropterin dihydrochloride|A dose of 20 mg/kg will be administered dissolved in water or apple juice, based on subject's age and ability, and taken orally once daily with food.
16273534|NCT00838396|Drug|XP19986 CR|
16273535|NCT00838396|Drug|Placebo for XP19986 CR|
16273536|NCT00838383|Drug|sitaxsentan (Thelin)|sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
16273537|NCT00838383|Drug|sitaxsentan (Thelin)|sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
16273538|NCT00838383|Drug|Placebo|Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
16273539|NCT00838370|Drug|Capecitabine, 5-fluorouracil|"Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD*2A. Patients heterozygous or homozygous mutant for DPYD*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased.
~In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients."
16273540|NCT00838357|Drug|Generic = Plerixafor|240µg/kg administered as an SC injection 10 to 11 hours prior to initiation of apheresis. Daily administration for 1 up to 5 consecutive days
16273541|NCT00838344|Other|Medication Adherence Program (MAP)|Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.
16273542|NCT00838331|Biological|Fresh blood|For fresh transfusions, a whole blood unit will be drawn from volunteers, processed, and then reinfused on the same day during the study. For impaired and repaired transfusions, the volunteers will be brought to the blood bank to donate; then, after processing and the appropriate length of storage (eg, 28 days), they will return for the FBF studies. Since recipients of fresh transfusions are relatively anemic after donation and before reinfusion, recipients of impaired/repaired transfusions should also be mildly anemic for the study. Thus, they will donate another whole blood unit prior to beginning the study course, they will be transfused with their stored unit during the study, and then the autologous unit collected at the beginning of the day will be reinfused at the end of the day after the study is complete.
16273543|NCT00838331|Biological|Aged blood|"In a separate aim, the FMD assay will be used to investigate NO-mediated vasodilation in patients with CVD who are receiving transfusions. Over 60% of blood orders for cardiology patients at Emory are for 2 units or more. Therefore, when a 2-unit order is placed on a consented patient, they will be issued both fresh (< 7 days) and impaired (> 28 days) compatible units from inventory. Prior to starting transfusions, the patient will be randomized to either receive the fresh or the older unit first. All RBC units will be ACD/AS1. Units will also be leukoreduced and/or irradiated, if either of those modifications were found to impair NO bioavailability in prior studies. If washing or rejuvenation were found to be successful in significantly repairing NO bioavailability in previous aims, some patients may also receive impaired and repaired (> 28 days; washed or rejuvenated) RBC transfusions."
16273544|NCT00838318|Behavioral|Interview|Audiotaped Phone Interview/Survey, 30 - 45 minutes.
16273545|NCT00838305|Drug|MDMA and citalopram|MDMA 1.5 mg/kg and citalopram 20 mg
16273546|NCT00838305|Drug|Placebo|drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
16273547|NCT00838292|Dietary Supplement|fortified blended flour - Insta Foundation Plus (with whey protein concentrate)|300 grams/day for 6 months
16273548|NCT00838292|Other|nutrition counseling|
16273549|NCT00838279|Drug|Lamotrigine 25 mg Chewable Tablets|2 x 25 mg, single-dose fasting
16273550|NCT00838279|Drug|Lamictal® 25 mg Chewable Tablets|2 x 25 mg, single-dose fasting
16273551|NCT00838266|Drug|mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate)|Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days
16273552|NCT00838266|Other|mouthrinse containing non-active component|Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
16273553|NCT00838253|Drug|Istaroxime|Istaroxime 0.5 μg/kg/min (30 μg/kg/h) continuous i.v. infusion for 24 hours
16273554|NCT00838253|Drug|Istaroxime|Istaroxime 1.0 μg/kg/min (60 μg/kg/h) continuous i.v. infusion for 24 hours
16273555|NCT00838253|Drug|Istaroxime|Istaroxime 1.5 μg/kg/min (90 μg/kg/h) continuous i.v. infusion for 24 hours
16273556|NCT00838253|Drug|Placebo|Placebo continuous i.v. infusion for 24 hours
16273557|NCT00838240|Drug|clofarabine|Given IV
16273558|NCT00838240|Drug|cytarabine|Given IV
16273559|NCT00838240|Drug|idarubicin|Given IV
16273560|NCT00838227|Drug|modafinil|Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
16273561|NCT00838214|Drug|budesonide|3mg capsule, 3x per day for 6 months
16273562|NCT00838214|Drug|prednisone|5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months
16273563|NCT00838201|Drug|Denosumab|60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
16273564|NCT00838188|Other|Way of Feeding - Breast feeding vs. Bottle feeding|Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
16273568|NCT00838162|Drug|TMC310911 300 mg twice daily|TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14
16273569|NCT00838162|Drug|TMC310911 300 mg once daily|TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14
16273570|NCT00838162|Drug|Ritonavir 100 mg twice daily|Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
16273571|NCT00838162|Drug|Ritonavir 100 mg once daily|Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
16273572|NCT00838149|Dietary Supplement|Glutamine|"Glutamine group :
~Glutamine would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble commercial preparation containing 10 gm of pure L- Glutamine in the crystalline form. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months."
16273573|NCT00838149|Dietary Supplement|Whey protein|"Whey protein group:
~Whey protein would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble whey protein concentrate containing 70 % protein. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months."
16273574|NCT00838136|Drug|Lamotrigine 25 mg Chewable Tablets|2 x 25 mg, single-dose fed
16273575|NCT00838136|Drug|Lamictal® 25 mg Chewable Tablets|2 x 25 mg, single-dose fed
16273576|NCT00838110|Drug|Dimebon|10 mg TID for week 1 followed by 20 mg TID through Week 26
16273577|NCT00838110|Drug|Placebo|10 mg TID for week 1 followed by 20 mg TID through Week 26
16273578|NCT00838110|Drug|Dimebon|10 mg TID for week 1 followed by 20 mg TID through Week 12
16273579|NCT00838110|Drug|Placebo|20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
16273580|NCT00838084|Drug|LY2811376|Oral capsules
16273581|NCT00838084|Drug|Placebo|Oral capsules
16273582|NCT00838071|Drug|Specific intravenous anti-hepatitis B immunoglobulin|Monthly doses of 5000 IU administered intravenously during 6 consecutive months
16273583|NCT00838058|Drug|CE-224,535|one 250mg tablet, once in the morning in fasted state
16273584|NCT00838058|Drug|CE-224,535|2x250 mg tablets, once in the morning, in fasted state
16273585|NCT00838058|Drug|CE-224,535|4x250mg tablets, once in the morning, in fasted state
16273586|NCT00838058|Drug|CE-224,535|2x250mg tab, once in the morning, after being fed a high fat meal
16273587|NCT00838058|Drug|CE-224,535|4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.
16273588|NCT00838058|Drug|CE-224,535|4x125 mg IR once in the morning after being fed a high fat meal
16273589|NCT00838058|Drug|CE 224,535|2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
16273590|NCT00838058|Drug|CE 224,535|2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
16273591|NCT00838045|Device|The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL|Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
16273592|NCT00838032|Drug|Quetiapine fumarate|Quetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator.
16273593|NCT00838032|Drug|Haloperidol|Haloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator.
16273594|NCT00838019|Procedure|Intrabone administration of umbilical cord blood|Single administration
16273595|NCT00838006|Device|heart rate variability biofeedback|Heart rate variability biofeedback, 3 session plus handheld device
16273596|NCT00838006|Device|Cognitive bias modification training|Cognitive bias modification training - 3 session plus handheld device
16273597|NCT00838006|Device|Sham Comparator|Subjects received iPod without a study app and no additional resilience training
16273598|NCT00837967|Drug|Symbicort Turbuhaler|160/4.5μg for 3 days
16273599|NCT00837967|Drug|Terbutaline Turbuhaler|0.4 mg for 3 days
16273600|NCT00837954|Device|Lyostypt® AND Surgicel®|"The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
~Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
~Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage."
16273601|NCT00837954|Device|Lyostypt®|"The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half.
~Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII."
16273602|NCT00837954|Procedure|Surgicel®|"The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
~Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage."
16273603|NCT00837941|Drug|Comparator: A: Pregabalin|1 Pregabalin 300 mg capsule
16273604|NCT00837941|Drug|Comparator: B: Duloxetine|1 Duloxetine hydrochloride 60 mg capsule
16273605|NCT00837941|Drug|Comparator: C: Diphenhydramine hydrochloride|1 Diphenhydramine hydrochloride 25mg capsule
16273606|NCT00837928|Drug|bendamustine|40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT.
16273607|NCT00837928|Other|laboratory biomarker analysis|samples will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. PK samples will not be collected from patients who begin SRT on day 1).
16273608|NCT00837928|Procedure|Surgical Resection of Brain Metastases|Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine)
16273609|NCT00837928|Radiation|Stereotactic body radiation therapy|Starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri)
16273610|NCT00837915|Drug|Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets|
16273611|NCT00837902|Drug|Atenolol (β-blocker)|25 mg tablet
16273612|NCT00837889|Drug|diuretics, inotropica|
16273613|NCT00837876|Drug|Sorafenib|400 mg taken by mouth 1 time per day.
16273614|NCT00837876|Drug|Erlotinb|150 mg taken by mouth 1 time per day.
16273615|NCT00837863|Drug|Somatropin|ALTU-238 0.3 mg/kg daily
16273616|NCT00837863|Drug|Somatropin|ALTU-238 0.6 mg/kg daily
16273617|NCT00837863|Drug|Somatropin|ALTU-238 0.9 mg/kg daily
16273618|NCT00837863|Drug|Somatropin|Nutropin AQ 0.043 mg/kg daily
16273619|NCT00837850|Device|Bone cement 1|Bone cement SmartSet® HV
16273620|NCT00837850|Device|Bone cement 2|Bone cement Palacos R
16273621|NCT00837837|Drug|Chlorpheniramine|
16273622|NCT00837824|Biological|Fabrazyme (agalsidase beta)|1.0 mg/kg every 2 weeks
16273623|NCT00837824|Biological|Fabrazyme (agalsidase beta)|3.0 mg/kg every 2 weeks
16273624|NCT00837811|Biological|LY2127399|60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
16273625|NCT00837798|Device|CRM Device|Pacemaker, ICD, or CRT device
16273626|NCT00837785|Drug|BG00012|240 mg (two 120 mg capsules) orally three times a day
16273627|NCT00837785|Drug|BG00012|240 mg (two 120 mg capsules) orally twice a day
16273628|NCT00837772|Device|Standard cutting guide for TKA|Use of the usual cutting guide for surgical replacement of a diseased knee
16273629|NCT00837772|Device|Otismed MRI generated cutting guide for TKA|Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee
16273630|NCT00837759|Drug|Insulin|
16273631|NCT00837759|Drug|Lansoprazole|
16273632|NCT00837759|Drug|Sitagliptin|
16273633|NCT00837759|Biological|Diamyd|
16273634|NCT00837759|Drug|GAD65 (Diamyd)|
16273635|NCT00837746|Drug|risedronate|risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years
16273636|NCT00837733|Procedure|Endometrial biopsy|Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter
16273637|NCT00837733|Procedure|Endometrial Biopsy|Biopsy catheter
16273638|NCT00837707|Drug|aripiprazole|Flexible dose: 5-30 mg/day
16273639|NCT00837655|Drug|Sevelamer|sevelamer tablets, 800 mg (Renagel(r), Genzyme Inc). The initial daily dose of sevelamer will be 2400 mg (800 mg x 3). After the first week of treatment the dose will be increased to 4800 mg. If treatment with sevelamer is well tolerated and if a phosphate concentration of <1.8 mmol/l is not obtained, the dose may be increased further. The maximum daily dose of sevelamer will be 9600 mg. If a patient experiences side effects, the dose of sevelamer will be reduced to the highest acceptable dose, and, if a phosphate concentration of <1.8 mmol/l is not obtained, the treatment will be supplemented with calcium carbonate in a dose tolerated by the patient.
16273640|NCT00837655|Drug|Calcium carbonate|Calcium carbonate tablets, 250 mg (Kalcidon, Abigo AB). Calcium carbonate will be prescribed at the dose given prior to the washout period. The dose will be adjusted weekly to obtain a serum phosphate concentration <1.8 mmol/l.
16273641|NCT00837642|Diagnostic Test|Transthoracic echocardiography|Full transthoracic echocardiography will be performed.
16273642|NCT00837616|Drug|17 B estradiol orally|Group A will be given estrogen by mouth daily(0.5 mg or 1mg or 2 mg of 17B Estradiol. Doses will vary depending on the blood levels of estrogen starting with the lower doses and adjusting these doses up as needed to keep the levels in the normal range. The estrogen will be taken for 21 days. In order to have a menstrual cycle progesterone will be given for 7 days, starting from day 14 through day 21 of each cycle. Then both medications are stopped on day 21 for a total of 7 days. Labs will be obtained at baseline, 1,2,3,6,9 and 12 months. Dual-energy X-ray absorptiometry (DXA) scan and calorimetry will be done at baseline and at 6 and 12 month.
16273643|NCT00837616|Drug|17 B estradiol|Group B will be given estrogen via a patch applied to the skin twice a week (0.375mg or 0.05mg or 0.075mg) Doses will vary depending on the blood levels of estrogen starting with the lower doses and adjusting these doses up as needed to keep the levels in the normal range. The estrogen will be taken for 21 days. In order to have a menstrual cycle progesterone will be given for 7 days, starting from day 14 through day 21 of each cycle. Then both medications are stopped on day 21 for a total of 7 days. Labs will be obtained at baseline, 1,2,3,6,9 and 12 months. Dual-energy X-ray absorptiometry (DXA) scan and calorimetry will be done at baseline and at 6 and 12 month.
16273644|NCT00837603|Behavioral|Training|Controlled home ergometer training
16273645|NCT00837590|Drug|Chronic salsalate|Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
16273646|NCT00837590|Drug|Acute Salsalate|Subjects will receive a single oral dose of 2 gram of oral salsalate
16273647|NCT00837577|Drug|Comparator: Placebo|Placebo to sitagliptin once daily for 12 weeks (double-blind period)
16273648|NCT00837577|Drug|Sitagliptin|"Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).
~Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20."
16273649|NCT00837577|Drug|Voglibose|"All participants received a stable dose of voglibose, in
~accordance with the package insert, throughout the study."
16273650|NCT00837564|Other|CBASP psychotherapy|specific psychotherapy for chronic depression
16273651|NCT00837564|Drug|Escitalopram|Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management
16273652|NCT00837551|Drug|WBI-1001|Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.
16273653|NCT00837525|Procedure|nasal valve implant|Injectable implantation of a biodegradable material for support of the Nasal valve.
16273654|NCT00837512|Device|Microneedle|Microneedle used to deliver insulin at a depth less than 900 micrometers
16274611|NCT00829842|Other|placebo|oral hygiene placebo
16273655|NCT00837512|Device|Subcutaneous insulin catheter|Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
16273656|NCT00837499|Behavioral|Questionnaire|Interview and survey during visit or by phone, 30 - 40 minutes.
16273657|NCT00837486|Device|Reclaim™ DBS System|
16273658|NCT00837473|Device|Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures|Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
16273659|NCT00837460|Other|rehabilitation|4 weeks of bilateral followed or preceded by 4 weeks of unilateral similar prehension oriented repeated rehabilitation tasks. About 45 minutes 3 times a week, the subject is coached by a physiotherapist to enhance his prehension habilities.
16273660|NCT00837447|Device|Total knee replacement with NexGen CR knee prosthesis|comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis
16273661|NCT00837447|Device|Total knee replacement(TKR) with Nexgen CR-flex|TKR using Nexgen CR-flex implant
16273662|NCT00837434|Drug|Etanercept|50 mg dose of etanercept by subcutaneous injection
16273663|NCT00837434|Drug|Adalimumab|40 mg dose of adalimumab by subcutaneous injection
16273664|NCT00837382|Behavioral|MEDVAMC Nightmare Treatment|Veteran Nightmare Treatment Using Imagery Rescripting
16273665|NCT00837382|Behavioral|Telepsychiatry Nightmare Treatment|Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing
16273666|NCT00837369|Drug|Regadenoson|400ug IV bolus injection, single dosage
16273667|NCT00837356|Drug|Advate®|Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
16273668|NCT00837356|Drug|turoctocog alfa|After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
16273669|NCT00837343|Drug|quetiapine fumarate tablet (Seroquel)|Investigational product: quetiapine fumarate tablet (Seroquel) , 25 mg, 200 mg, 300mg, manufactured by AstraZeneca.The total daily doses of quetiapine fumarate will be increased to 600mg/d on the 6th since enrolment day. At day 7 or later, the dose can be adjusted in the range of 400- 800mg/day.
16273670|NCT00837330|Drug|ranibizumab 0.5 or 0.3 mg/0.05 cc|ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
16273671|NCT00837317|Dietary Supplement|Olive Oil, SF, SF+DMP, SF+phenols|All the volunteer subjects will be administered four breakfast meals that have been prepared with four different types of oil, each of which will have been subjected to a standardised frying. The meals will be administered according to a cross-randomized Latin squares design
16273672|NCT00837304|Device|PillCam Colon Capsule|PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends. It is 31.11 mm in size and takes pictures at a rate of 4 frames per second. The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
16273673|NCT00837304|Procedure|Standard Colonoscopy|Standard Colonoscopy: Pts. undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
16273674|NCT00837291|Drug|CF101|CF101 tablets 1 mg BID
16273675|NCT00837291|Drug|Placebo|Placebo tablets BID
16273676|NCT00837265|Biological|Neugranin|Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor)at two dose levels or comparator (pegfilgrastim 6 mg) administered approximately 24 hours following chemotherapy for 4 treatment cycles
16273677|NCT00837265|Drug|Pegfilgrastim|6mg
16273678|NCT00837265|Drug|Chemotherapy|study treatment was administered 24 hours after initiation of chemotherapy
16273679|NCT00837252|Drug|Finasteride|Participants received 5mg of oral finasteride daily for three months.
16273680|NCT00837239|Drug|Gemcitabine|1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle).
16273681|NCT00837239|Drug|HuaChanSu|20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle).
16273682|NCT00837239|Drug|Placebo|500 ml saline only administered as a 2 hour infusion by central line.
16273683|NCT00837213|Drug|Benzoyl peroxide with clindamycin|Benzoyl peroxide wash - Clindamycin foam
16273684|NCT00837213|Drug|Benzoyl peroxide with clindamycin and doxycycline|Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
16273685|NCT00837200|Drug|Oncaspar, Doxil, Decadron|Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
16273686|NCT00837187|Drug|Intravenous dexmedetomidine|100 ug
16273687|NCT00837187|Drug|Intranasal dexmedetomidine|100 ug
16273688|NCT00837174|Drug|Vorinostat in combination with Bortezomib|Patients will be treated with oral vorinostat on days 1 through 14 followed by a 7-day rest period, for a 21-day treatment cycle for up to 6 cycles in the absence of disease progression or unacceptable toxicity. The patients will receive once-daily oral vorinostat (400 mg) with bortezomib 1.3 mg/m2 as an IV push on days 1, 4, 8, 11.
16273689|NCT00837161|Device|Philips MR guided HIFU system|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis
16273690|NCT00837148|Drug|Sorafenib and Dacarbazine|"Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles.
~All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance."
16273691|NCT00837135|Other|Screening|"A. SCREENING
~Consent
~Disease Evaluation (CT Scan/MRI; EGC/EUS; Laparoscopy)
~Physical Exam, History, Blood Tests
~Skin Test (for allergy to saccaromyces cerevisiae) yeast.
~Collection of Blood for research
~B. CHEMOTHERAPY AND RADIATION (as determined by Doctor)
~C. ENROLLMENT INTO ACTIVE PART OF STUDY
~Consent
~Chemotherapy
~GI-4000 Vaccine #1 + Prevnar + Activated T Cells
~GI-4000 Vaccine #2
~Disease Evaluation (CT Scan/MRI). If disease has spread, subject is taken off study. If disease is stable, subject go on to ARM A or ARM B."
16274655|NCT00829504|Drug|Ropinirole HCl 0.25 mg Tablets|1 x 0.25 mg
16273692|NCT00837135|Biological|GI-4000 Vaccine|"Chemotherapy and Radiation
~GI-4000 Vaccine #3
~GI-4000 Vaccine #4"
16273693|NCT00837135|Biological|GI-4000 Vaccine + Activated T Cells|"Apheresis #2
~Chemoradiation
~Activated T Cells + GI-4000 Vaccine #3
~GI-4000 Vaccine #4"
16273694|NCT00837135|Biological|Surgical Evaluation after Vaccine #4|"SURGICAL EVALUATION (to determine disease status) A. For those who have complete removal of tumor. These subjects will continue to receive Chemotherapy AND GI-4000 Vaccination Monthly during Chemotherapy. Disease evaluation every 3-6 months (CT Scan/MR.
~B. For those sucjects who cannot have surgery or who have not had complete removal of tumor. These subjects will continue to have GI-4000 Vaccinations Monthly as long as there is no disease progression. Disease evaluation every 3-6 months (CT Scan/MR."
16273695|NCT00837109|Behavioral|Veteran Nightmare Treatment|Veteran Nightmare Treatment Using Imagery Rescripting
16273696|NCT00837109|Behavioral|Treatment-as-usual|Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)
16273697|NCT00837096|Device|V.A.C. Therapy|Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.
16273698|NCT00837096|Device|Moist wound therapy (MWT)|Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
16273699|NCT00837070|Procedure|Percutaneous zygapophyseal cyst rupture|Patients will be treated by introducing a 20G spinal needle in the inferior joint recess of the zygapophyseal joint.1 ml of celestone-chronodose,1 ml of Marcain 5 mg/ml and 1-3 ml of contrast media:Omnipaque 240 will be injected until the cyst ruptures.
16273700|NCT00837057|Procedure|crrt|early CRRT (35 ml/kg/h)& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication
16273701|NCT00837044|Drug|Treximet|Treximet
16273702|NCT00837044|Drug|Migraine rescue medication of choice|Migraine rescue medication of choice
16273703|NCT00837031|Drug|Lenalidomide|The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold.
16273704|NCT00837031|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.
16273705|NCT00837018|Other|physical exercise program|45 min, 3times a week
16273706|NCT00836953|Biological|Influenza virus vaccine (Pediatric formulation)|0.25 mL, Intramuscular
16273707|NCT00836940|Drug|GRC 8200|Capsules, 25 to 100mg, once/ twice a day, 12 weeks
16273708|NCT00836927|Drug|Ridaforolimus Tablet|Ridaforolimus 10 mg oral tablet
16273709|NCT00836927|Drug|Ridaforolimus Intravenous (IV) Infusion|Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
16273710|NCT00836914|Drug|CAL-101|CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
16273711|NCT00836914|Drug|Placebo|Placebo capsules administered orally BID for 7 days
16273712|NCT00836901|Drug|amoxicillin-clavulanic acid|400 mg-57 mg chewable tablet
16273713|NCT00836901|Drug|Augmentin®|400 mg-57 mg chewable tablet
16273714|NCT00836888|Biological|ONO-4538|1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts
16273715|NCT00836875|Drug|Voriconazole|"All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.
~Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.
~Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing <50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension."
16273716|NCT00836862|Other|Biologic specimens|Banking of serum, DNA and tissue
16273717|NCT00836849|Drug|Zoloft® 100 mg Tablets|1 x 100 mg, single-dose fed
16273718|NCT00836849|Drug|Sertraline hydrochloride 100 mg Tablets|1 x 100 mg, single-dose fed
16273719|NCT00836836|Other|Modified Atkins diet|"Modified Atkins Diet administration
~Carbohydrates intake will be restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
~Fats (e.g. cream, butter, oils, ghee) encouraged.
~Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
~Clear carbohydrate-fluids not restricted.
~Calcium and multivitamin supplementation will be provided."
16273720|NCT00836823|Drug|Alfuzosin|Alfuzosin 10mg once daily for 12 months
16273721|NCT00836810|Drug|Timed Release Tablet Prednisone|Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.
16273722|NCT00836810|Drug|Prednisolone|Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.
16273723|NCT00836784|Other|old toothbrush|All children will receive new tooth brush 3 months before starting the study, at the end of 3 month the worn tooth brushes will be returned and the surface area within the outline will be determine using NIH (national institutes of health) image software.
16273724|NCT00836784|Other|New tooth brush|"The tooth brush which will be use in this study is Jordan. A new Jordan toothbrush will be give to all children, and in new tooth brush group they will use these toothbrushes."
16273725|NCT00836771|Dietary Supplement|Infant Formula|
16273726|NCT00836758|Device|Analysis with AED and manual PSG scoring|The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.
16273727|NCT00836745|Other|Non Interventional|Sutent capsule, once daily administered per the locally approved product information.
16274656|NCT00829504|Drug|Requip® 0.25 mg Tablets|1 x 0.25 mg
16273728|NCT00836732|Procedure|harvest of a small bone marrow sample|harvest of a small bone marrow sample during open chest surgery
16273729|NCT00836719|Drug|Polyphenon E|Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
16273730|NCT00836706|Drug|clarithromycin|500 mg Tablet
16273731|NCT00836706|Drug|BIAXIN®|500 mg Tablet
16273732|NCT00836693|Drug|tadalafil|5 milligrams (mg) administered orally once a day for 12 weeks
16273733|NCT00836693|Drug|placebo|tablet administered orally once a day for 12 weeks.
16273734|NCT00836680|Device|Colorectal Stent|"Diagnosis of an internal rectal prolapse:
~The device will be introduced and placed into the patient via a proctoscopic procedure. After that the doctor can measure and determine the internal rectal prolapse. After the diagnosis results have been received, the device will be removed from the patient via proctoscopic examination. The whole procedure will take approx. 5 minutes.
~An additional X-ray examination procedure with the use of contrast media will be made for the determination of a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch."
16273735|NCT00836667|Drug|Zoloft® 100 mg Tablets|1 x 100 mg, single-dose fed
16273736|NCT00836667|Drug|Sertraline hydrochloride 100 mg Tablets|1 x 100 mg, single-dose fed
16273737|NCT00836654|Biological|Catumaxomab (Removab)|Puncture free survival
16273738|NCT00836654|Procedure|paracentesis|
16273739|NCT00836641|Biological|prevenar|7-valent pneumococcal conjugate vaccine
16273740|NCT00836641|Biological|pneumovax|23 valent pneumococcal polysaccharide vaccine
16273741|NCT00836628|Drug|Busulfan|
16273742|NCT00836602|Drug|BMS-779788|Oral Solution, Oral, 1 mg, Once daily, 7 days
16273743|NCT00836602|Drug|BMS-779788|Oral Solution, Oral, 2 mg, Once daily, 7 days
16273744|NCT00836602|Drug|BMS-779788|Oral Solution, Oral, <= 4 mg, Once daily, 7 days
16273745|NCT00836602|Drug|Placebo|Oral Solution, Oral, 0 mg, Once daily, 7 days
16273746|NCT00836589|Device|ICD Therapy - ICD Lead Registry|Collecting long-term safety and efficacy data on a family of market-released ICD leads.
16273747|NCT00836576|Drug|Benazepril HCl 40 mg Tablets|1 x 40 mg, single-dose fasting
16273748|NCT00836576|Drug|Lotensin® 40 mg Tablets|1 x 40 mg, single-dose fasting
16273749|NCT00836550|Behavioral|Video|The participants saw a 6 minute video
16273750|NCT00836550|Behavioral|in-person HIV pre-test counseling|
16273751|NCT00836537|Drug|Benazepril HCl 40 mg Tablets|1 x 40 mg, single-dose fed
16273752|NCT00836537|Drug|Lotensin® 40 mg Tablets|1 x 40 mg, single-dose fed
16273753|NCT00836524|Procedure|ultrasound|4 ultrasound examinations during pregnancy and every time a blood sample is colletted. blood sample from the mother and the umbilical cord is collected as well
16273754|NCT00836498|Biological|Comparator: RotaTeq|Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
16273755|NCT00836498|Biological|Comparator: Placebo|Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
16273756|NCT00836498|Biological|Comparator: RotaTeq + Placebo|One 2.0 mL oral dose of RotaTeq and two 2.0 mL oral doses of placebo over an approximately 3-5 month treatment period
16273757|NCT00836485|Drug|Ketotifen 4.0% Patch|This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
16273758|NCT00836485|Drug|Placebo|The control is a placebo patch that contains only the inactive ingredients of ketotifen.
16273759|NCT00836485|Drug|Olopatadine 0.2%|1 gtt/eye on two separate occasions
16273760|NCT00836485|Drug|Artificial tears|1 gtt/eye on two separate occasions
16273761|NCT00836472|Drug|Glyburide/Metformin 5 mg/500 mg Tablets|1 x 5 mg/500 mg, single-dose fasting
16273762|NCT00836472|Drug|Glucovance® 5 mg/500 mg Tablets|1 x 5 mg/500 mg, single-dose fasting
16273763|NCT00836459|Behavioral|Mini Booster|Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
16273764|NCT00836459|Behavioral|Full Booster|Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
16273765|NCT00836446|Other|physical activity|physical activity routines 5 times a weeks for 12 weeks.
16273766|NCT00836433|Behavioral|CONNECT educational intervention|The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving. Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.
16273767|NCT00836433|Behavioral|FALLS educational intervention|FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
16273768|NCT00836420|Procedure|no intervention|the value of the clinical use of microdialysis monitoring of the brain
16273769|NCT00836407|Drug|Ipilimumab|Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
16273770|NCT00836407|Biological|Pancreatic Cancer Vaccine|The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
16273771|NCT00836394|Device|Galileo (whole body vibration (WBV) therapy)|6 minutes of training on 5 days a week for 3 months
16273772|NCT00836381|Drug|Tolterodine extended-release (ER) 4mg|Tolterodine extended-release (ER) 4mg once daily for 12 weeks
16273773|NCT00836381|Drug|Placebo|Identical Placebo once daily
16273774|NCT00836368|Dietary Supplement|gamma-tocopherol|oral doses 1,200 mg of gamma tocopherol (2 capsules of the gamma tocopherol enriched vitamin E preparation)
16273775|NCT00836355|Drug|Enoxaparin|2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
16273776|NCT00836355|Drug|Minocycline|200 mg orally once daily for 5 days
16273806|NCT00836082|Drug|PF-04457845, FAAH inhibitor|Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days.
16275100|NCT00826202|Other|Placebo|Inert Placebo
16273777|NCT00836329|Behavioral|Intensive Glucose Management|Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU). Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL. Prior to hospital discharge, participants will receive an in-depth diabetes education session. After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
16273778|NCT00836329|Behavioral|Traditional Glucose Management:|Participants will receive traditional management of blood glucose levels while in the hospital. They may receive insulin several times a day, based on the results of glucose monitoring.
16273779|NCT00836316|Drug|levobupivacaine|intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy
16273780|NCT00836303|Behavioral|Colorecatal Cancer Screening Activation|Research assistants showed intervention patients a colorectal cancer educational video in Spanish on a portable personal digital video display device while the patients were waiting for their visit. The 11-minute video was developed by the National Alliance for Hispanic Health and was accompanied by a brochure with key information from the video {http://www.hispanichealth.org/publication/}. Intervention patients were also given a one-page reminder to hand to their physicians notifying them 1) of their patients' eligibility for colorectal cancer screening, and 2) of their patients' receipt of CRC educational material.
16273781|NCT00836290|Behavioral|Pre-Release (Group 1)|Participants in the pre-release intervention group will receive four sessions in the four-week period prior to release and will receive a comprehensive booster session four weeks after release.
16273782|NCT00836290|Behavioral|Post-release (Group 2)|Participants in the post-release intervention group will receive one comprehensive introductory session four weeks before release and four sessions during the four-week period after release.
16273783|NCT00836277|Drug|Panitumumab|9mg/kg IV Day 1 Cycle = 21 days
16273784|NCT00836277|Drug|Irinotecan|125mg/m2 IV Day 1 and Day 8
16273785|NCT00836251|Dietary Supplement|H218O and 2H2O, administered as a mixed cocktail|0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail
16273786|NCT00836238|Behavioral|Interview|Physical Function and Symptom Assessment Interviews
16273787|NCT00836238|Other|Physical Function Tests|3 physical function tests.
16273788|NCT00836225|Drug|ISIS 388626|"4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg
~Placebo: 0.9% sterile saline"
16273789|NCT00836212|Drug|Reducing dose of Lopinavir|Patients with blood levels measured 2 times at 2 weeks intervals in the upper quartile (>percentile 75) of concentrations reported under standard therapy (i.e. EFV 600 mg q.d. or LPV/r 400 or 533 mg bid) will have their dose reduced by approximately one third, with the aim to bring their concentration in the 25-75% percentile range.
16273790|NCT00836212|Drug|Reducing dose of efavirenz|Patients with blood levels measured 2 times at 2 weeks intervals in the upper quartile (>percentile 75) of concentrations reported under standard therapy (i.e. EFV 600 mg q.d. or LPV/r 400 or 533 mg bid) will have their dose reduced by approximately one third, with the aim to bring their concentration in the 25-75% percentile range.
16273791|NCT00836199|Biological|NicVAX vaccine|NicVAX vaccine given 6 times over 6 months
16273792|NCT00836199|Biological|Placebo vaccine|Placebo vaccine given 6 times over 6 months
16273793|NCT00836186|Radiation|Radiation therapy|Patients will receive whole breast radiation therapy at a dose of 180-200 centigray (cGy) per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.
16273794|NCT00836173|Drug|RICE|RICE treatment: Rituximab by intravenous infusion over 6-8 hours on day 1, Eptoposide by intravenous infusion over 2 hours on day 3-5, a 1-hour infusion of Carboplatin on day 4 and a 24-hour infusion of Ifosfamide on day 4, each cycle is 14 days (2 weeks). Patients will receive 3 cycles of RICE treatment.
16273795|NCT00836173|Drug|GaRD Treatment|After RICE treatment, patients will have gallium nitrate IV through a vein continuously over a 7 day period. Patients will also receive rituximab by intravenous infusion over a 3-6 hour period on day 1 of each cycle. Dexamethasone will be given as pills to be taken for 4 days in a row on the first 4 days of each cycle. The length of each cycle is 21 days (3 weeks). All patients will have 2 cycles of GaRD.
16273796|NCT00836147|Drug|Avotermin (Juvista)|20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs after wound closure.
16273797|NCT00836147|Drug|Placebo|20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs after wound closure.
16273798|NCT00836134|Procedure|rectus sheath block|ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision
16273799|NCT00836134|Procedure|local anesthetic infiltration|Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery
16273800|NCT00836121|Procedure|right thoracotomy|complete surgical resection
16273801|NCT00836108|Behavioral|breathing strategy|Subjects will practice a rhythmic overhead arm exercise, during which they will be taught to inspire when they elevate their arms or they will be taught to expire when they elevate their arms or, a third group, will practice a rhythmic overhead arm exercise, during which they will not be provided with any instruction regarding a specific breathing pattern. The arm exercise practiced by all groups will be identical.
16273802|NCT00836095|Device|Supreme Laryngeal mask airway|Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
16273803|NCT00836095|Device|Proseal laryngeal mask airway|Proseal is a multiple use, variant of the laryngeal mask airway
16273804|NCT00836082|Drug|PF-04457845, FAAH inhibitor|Oral solution of 0.5mg given once daily for 14 days.
16273805|NCT00836082|Drug|PF-04457845, FAAH inhibitor|Oral solution of 1mg given once daily for 14 days.
16273964|NCT00834964|Drug|Effexor® 25 mg Tablets|1 x 25 mg, single-dose fasting
16273807|NCT00836082|Drug|PF-04457845, FAAH inhibitor|A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
16273808|NCT00836082|Drug|PF-04457845, FAAH inhibitor|Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days.
16273809|NCT00836082|Drug|PF-04457845, FAAH inhibitor|A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
16273810|NCT00836069|Drug|No drug name provided by Sponsor; drug referenced as PD 0332334|Experimental study drug for generalized anxiety disorder, oral tablet, at a total daily dose of 450mg or 600mg, twice daily for 8 weeks and then 2 weeks of dose tapering.
16273811|NCT00836069|Drug|Paroxetine|FDA Approved medication for generalized anxiety disorder, oral tablet, at 20mg, once daily for 8 weeks and then 2 weeks of dose tapering.
16273812|NCT00836069|Drug|Placebo|inactive substance, oral tablet, once per day, for 10 weeks.
16273813|NCT00836056|Drug|Clindamycin 300 mg capsule|1 x 300 mg
16273814|NCT00836056|Drug|Cleocin HCl 300 mg capsules|1 x 300 mg
16273815|NCT00836043|Drug|Alemtuzumab (MabCampath)|Intravenous therapy according to product information.
16273816|NCT00836030|Other|No treatment given|No treatment given
16273817|NCT00836017|Other|No Intervention|No intervention was administered as part of the study.
16273818|NCT00836004|Drug|Clindamycin 300 mg capsule|1 x 300 mg
16273819|NCT00836004|Drug|Cleocin HCl 300 mg capsules|1 x 300 mg
16273820|NCT00835991|Drug|Glyburide/Metformin 5 mg/500 mg Tablets|1 x 5 mg/500 mg, single-dose fed
16273821|NCT00835991|Drug|Glucovance® 5 mg/500 mg Tablets|1 x 5 mg/500 mg, single-dose fed
16273822|NCT00835978|Drug|axitinib|axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
16273823|NCT00835978|Drug|axitinib|axitinib 5mg BID (open-label) + placebo dose titration (blinded)
16273824|NCT00835978|Drug|axitinib|axitinib 5mg BID (open-label)
16273825|NCT00835965|Drug|Dexamethasone|Dexamethasone 5 mg administered intravenously following endotracheal intubation
16273826|NCT00835965|Drug|Aprepitant|Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
16273827|NCT00835965|Drug|Placebo Dexamethasone|
16273828|NCT00835952|Drug|ATX-101|ATX-101 single doses
16273829|NCT00835939|Drug|25% Dextrose and 1% Lidocaine|Up to 3 injections provided to neovessels outside of the tendon
16273830|NCT00835939|Drug|Lidocaine|Up to 3 injections provided to neovessels outside of the tendon
16273831|NCT00835939|Procedure|sclerotherapy|
16273832|NCT00835926|Biological|Influenza virus vaccine|0.5 mL, Intramuscular
16273833|NCT00835926|Biological|Influenza virus vaccine|0.5 mL, Intramuscular
16273834|NCT00835900|Drug|varenicline|variable dosing schedule
16273835|NCT00835900|Drug|placebo|placebo
16273836|NCT00835887|Dietary Supplement|low and high dose flavanoids|treatment with flavanoid-rich or flavanoid-low cacao twice daily
16273837|NCT00835874|Drug|Probiotics|Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.
16273838|NCT00835861|Drug|Metformin|Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control. If glycemic control can not be achieved with Metformin as a single agent insulin will be added.
16273839|NCT00835861|Drug|Insulin|Women randomized to the Insulin group will receive standard diet and glycemic monitoring education. They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
16273840|NCT00835848|Drug|Exenatide|Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
16273841|NCT00835848|Drug|Saline|Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
16273842|NCT00835835|Other|Body-weight supported treadmill training +/- Lokomat assistance|walking
16273843|NCT00835835|Other|Usual Care - no active intervention|No treatment used for comparison
16273844|NCT00835822|Drug|Venocur Triplex®|Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.
16273845|NCT00835822|Drug|placebo|Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.
16273846|NCT00835796|Drug|Finasteride 5 mg tablets|1 x 5 mg, single dose fasting
16273847|NCT00835796|Drug|PROSCAR® 5mg tablets|1 x 5 mg, single dose fasting
16273848|NCT00835770|Drug|dimethyl fumarate|BG00012 capsules
16273849|NCT00835770|Drug|Placebo|Capsules taken to maintain the blind in the 240 mg BID treatment group.
16273850|NCT00835744|Drug|clomiphene citrate|ovulation induction
16273851|NCT00835744|Drug|gonadotropins|ovulation induction
16273852|NCT00835731|Drug|misoprostol|400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E
16273853|NCT00835731|Device|Dilapan-S, vitamin B-12|One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E
16273854|NCT00835718|Drug|Comparator: MK0594 5 mg/day|MK0594 5 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 15 mg MK0594 will be administered.
16274070|NCT00834158|Procedure|PVE|1 time
16273855|NCT00835718|Drug|Comparator: MK0594 1 mg/day|MK0594 1 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
16273856|NCT00835718|Drug|Comparator: MK0594 1 mg/week|MK0594 1 mg tablets taken orally once every 7 days for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.
16273857|NCT00835718|Drug|Comparator: Placebo to MK0594|Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
16273858|NCT00835705|Drug|amoxicillin-clavulanic acid|400 mg-57 mg chewable tablet
16273859|NCT00835705|Drug|Augmentin®|400 mg-57 mg chewable tablet
16273860|NCT00835692|Drug|Clarithromycin|500 mg Tablet
16273861|NCT00835692|Drug|Biaxin®|500 mg Tablet
16273862|NCT00835679|Biological|cetuximab|Given IV
16273863|NCT00835679|Drug|dasatinib|Given orally
16273864|NCT00835679|Procedure|therapeutic conventional surgery|Undergo surgery
16273865|NCT00835679|Other|laboratory biomarker analysis|Correlative studies
16273866|NCT00835666|Drug|Finasteride 5 mg tablets|1 x 5 mg, single dose fasting
16273867|NCT00835666|Drug|PROSCAR®|1 x 5 mg, single dose fasting
16273868|NCT00835653|Procedure|median nerve block|median nerve block performed under echographic guidance
16273869|NCT00835653|Procedure|median nerve block|median nerve block performed under echographic guidance
16273870|NCT00835640|Drug|Fexofenadine 180 mg tablets|1 x 180 mg
16273871|NCT00835640|Drug|ALLEGRA® 180 mg tablets|1 x 180 mg
16273872|NCT00835627|Drug|sertraline|flexible dose sertraline
16273873|NCT00835627|Behavioral|CBT-ip|cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions
16273874|NCT00835627|Other|Combined (sertraline + CBT-ip)|flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions
16273875|NCT00835627|Other|Standard Care|community care, treatment as usual: routine follow up with existing providers
16273876|NCT00835614|Drug|Cefprozil for oral suspension 250 mg/5 mL|1 x 250 mg/5 mL, single-dose fasting
16273877|NCT00835614|Drug|CEFZIL® for Oral Suspension 250 mg/5mL|1 x 250 mg/5 mL, single-dose fasting
16273878|NCT00835588|Drug|Pantoprazole Sodium 40 mg delayed-release tablets|1 x 40 mg
16273879|NCT00835588|Drug|PROTONIX® 40 mg delayed-release tablets.|1 x 40 mg
16273880|NCT00835575|Drug|Mirtazapine 15 mg (Orally Disintegrating) Tablets|1 x 15 mg, single-dose fasting
16273881|NCT00835575|Drug|REMERON SolTab® 15 mg Orally Disintegrating Tablets|1 x 15 mg, single-dose fasting
16273882|NCT00835562|Procedure|Non-surgical management|Non-surgical management (physiotherapy and self-training)
16273883|NCT00835562|Procedure|Osteosynthesis|Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
16273884|NCT00835562|Procedure|Hemiarthroplasty|Primary modular hemiarthroplasty followed by physiotherapy and self-training
16273885|NCT00835549|Drug|Cefdinir for oral suspension 250 mg/5mL|1 x 250 mg/5mL, single-dose non-fasting
16273886|NCT00835549|Drug|OMNICEF® for oral suspension 250 mg/5mL|1 x 250 mg/5mL, single-dose non-fasting
16273887|NCT00835536|Drug|Ribavirin 200 mg tablets|1 x 200 mg, single-dose non-fasting
16273888|NCT00835536|Drug|COPEGUS™ 200 mg Tablets|1 x 200 mg, single-dose non-fasting
16273889|NCT00835510|Drug|Butenafine cream 1% manufactured by Taro|Treatment applied to affected area twice daily for 7 days
16273890|NCT00835510|Drug|Lotrimin Ultra (butenafine) 1%|Treatment applied to affected area twice daily for 7 days
16273891|NCT00835510|Drug|Butenafine Vehicle manufactured by Taro|Treatment applied to affected area twice daily for 7 days
16273892|NCT00835497|Drug|5 mg/500 mg Glipizide Metformin Hydrochloride Tablets|1 x 5 mg/500 mg, single-dose fasting
16273893|NCT00835497|Drug|5 mg/500 mg METAGLIP™ Tablets|1 x 5 mg/500 mg, single-dose fasting
16273894|NCT00835484|Drug|Cefdinir Capsules 300 mg|1 x 300 mg, single-dose fasting
16273895|NCT00835484|Drug|OMNICEF® 300 mg|1 x 300 mg, single-dose fasting
16273896|NCT00835471|Drug|erlotinib plus docetaxel or pemetrexed|"non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.
~squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression."
16273897|NCT00835471|Drug|erlotinib|erlotinib 150 mg/day continuously until disease progression
16273898|NCT00835458|Procedure|gastro-gastric fistula closure|The mucosa surrounding the orifice of the fistula will be ablated using standard endoscopic techniques. Remnants of mucosa will be treated with argon-plasma coagulation. The mucosa free orifice of the fistula will be closed using the Tissue Apposition System. Tissue anchors with attached threads will be deployed through the intestinal wall full thickness using delivery needles through the working channel of the endoscope. After two anchors are deployed on both sides of the fistulas' orifice a knotting element will be cinched down to approximate the two sides of the fistulas' orifice. The procedure will be repeated until the fistulas' orifice is securely closed.
16273899|NCT00835432|Device|Ossix|Test group
16273900|NCT00835432|Device|Biogide|controls
16273901|NCT00835419|Drug|P276-00|P276-00 -small molecule Cdk 4-D1, Cdk1-B and Cdk9-T inhibitor
16273902|NCT00835406|Drug|Alendronate Sodium Tablets 70mg|1 x 70mg, single dose fasting
16273903|NCT00835406|Drug|Fosamax® Tablets 70mg|1 x 70 mg, single dose fasting
16273904|NCT00835393|Drug|Pantoprazole Sodium 40 mg delayed-release tablets|1 x 40 mg
16273905|NCT00835393|Drug|PROTONIX® 40 mg delayed-release tablets.|1 x 40 mg
16273906|NCT00835380|Biological|Hepatitis A Vaccine, Purified Inactivated (VAQTA™)|Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.
16273907|NCT00835367|Drug|Amlodipine-benazepril 10 mg-20 mg capsules|1 x 10-20 mg
16273908|NCT00835367|Drug|Lotrel® 10 mg-20 mg capsule|1 x 10-20 mg
16273909|NCT00835354|Drug|Cefprozil for oral suspension 250 mg/5 mL|1 x 250 mg/5 mL, single-dose fasting
16273910|NCT00835354|Drug|CEFZIL® for Oral Suspension 250 mg/5mL|1 x 250 mg/5 mL, single-dose fasting
16273911|NCT00835328|Drug|Exendin (9-39)|A short-term intravenous infusion of the investigational drug, Exendin (9-39), will be administered over up to 9 hours.
16273912|NCT00835328|Drug|Vehicle|A short-term intravenous infusion of normal saline (0.9% NaCl), or the vehicle, will be administered over up to 9 hours.
16273913|NCT00835302|Procedure|Cervicothoracic manipulation|Thrust and non-thrust manipulation to the cervical and thoracic spine
16273914|NCT00835289|Dietary Supplement|n-3 polyunsaturated fatty acids|Omax3[TM] (Cenestra Health [TM]) is a 1 g softgel capsule containing 94.5% omega-3 fatty acids. Each serving size is a 1 gram capsule, which contains 690 mg of eicosapentanoic acid (EPA) and 182 mg of docosahexanoic acid (DHA). Inactive ingredients include: Vitamin E/Tocopherol 2294 ppm (in a carrier of partially hydrogenated vegetable oils including soybean oil), gelatin, glycerol, and purified water (components of the capsule shell). The study participants will be randomized to 3 softgel capsules a day for 6 months.
16273915|NCT00835289|Other|Placebo|3 capsules of matching corn oil placebo
16273916|NCT00835276|Drug|Fexofenadine 180 mg tablets|1 x 180 mg
16273917|NCT00835276|Drug|ALLEGRA® 180 mg tablets|1 x 180 mg
16273918|NCT00835263|Drug|Lamotrigine|200 mg Tablet
16273919|NCT00835263|Drug|Lamictal®|200 mg Tablet
16273920|NCT00835250|Procedure|Transvaginal hybrid NOTES cholecystectomy|Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.
16273921|NCT00835250|Procedure|Cholecystectomy|Extirpation of the gallbladder by a surgical procedure
16273922|NCT00835237|Biological|Boostrix®|Intramuscular, single dose.
16273923|NCT00835237|Biological|Decavac™|Intramuscular, single dose.
16273924|NCT00835224|Drug|L-NAME|A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.
16273925|NCT00835224|Drug|Midodrine|To treat low blood pressure.
16273926|NCT00835224|Drug|Placebo|A pill with an inactive substance that looks like the study drug.
16273927|NCT00835211|Drug|Desmopressin Acetate 0.2 mg Tablets|4 x 0.2 mg, single-dose fasting
16273928|NCT00835211|Drug|DDAVP® 0.2 mg Tablets|4 x 0.2 mg, single-dose fasting
16273929|NCT00835198|Drug|Dapsone; Tretinoin|Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
16273930|NCT00835198|Drug|Tretinoin|Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
16273931|NCT00835185|Biological|IMC-11F8 (necitumumab)|IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1
16273932|NCT00835185|Drug|Oxaliplatin|Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1
16273933|NCT00835185|Drug|Folinic acid (FA)|FA 400 mg/m² IV infusion bolus injection
16273934|NCT00835185|Drug|5-FU|5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours
16273935|NCT00835172|Drug|Glimepiride 4 mg Tablets|1 x 4 mg, single-dose non-fasting
16273936|NCT00835172|Drug|AMARYL® 4 mg Tablets|1 x 4 mg, single-dose non-fasting
16273937|NCT00835159|Drug|Rivastigmine Patch|Rivastigmine Patch 4.6 mg/24 hours: 5 cm2 size containing 9 mg rivastigmine applied to upper back preoperatively for a period of 24 hours
16273938|NCT00835159|Other|Placebo Patch|A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours.
16273939|NCT00835146|Drug|Ribavirin 200 mg tablets|1 x 200 mg, single-dose fasting
16273940|NCT00835146|Drug|COPEGUS™|1 x 200 mg, single-dose fasting
16273941|NCT00835133|Other|biologic sample preservation procedure|one blood sample or saliva sample collection
16273942|NCT00835133|Other|medical chart review|confirmation of cancer diagnosis
16273943|NCT00835133|Other|survey administration|at baseline enrollment and 12 months post-enrollment
16273944|NCT00835120|Drug|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
16273945|NCT00835107|Drug|ziprasidone hydrochloride|oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
16273946|NCT00835107|Drug|placebo|placebo comparator, oral capsules, BID, for one month
16273947|NCT00835094|Device|Mometasone furoate|MF-DPI 400 mcg once daily in the morning for 12 weeks
16273948|NCT00835094|Device|Mometasone furoate|MF-DPI 400 mcg once daily in the evening for 12 weeks
16273949|NCT00835081|Drug|Cefadroxil 500 mg Capsules|1 x 500 mg
16273950|NCT00835081|Drug|DURICEF® capsules 500 mg|1 x 500 mg
16273951|NCT00835068|Other|No intervention|As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
16273952|NCT00835042|Drug|Moexipril HCl/hydrochlorothiazide 15/25 mg tablets|1 x 15/25 mg
16273953|NCT00835042|Drug|UNIRETIC® 15/25 mg tablets|1 x 15/25 mg
16273954|NCT00835029|Drug|Clotrimazole varnish|Each patient will receive 14 syringes (with no needle, equivalent to 50 mg of Clotrimazole in each one) . The varnish will be applied on a dried denture at the inner side by means of a soft brush and left to dry for 60 sec for 14 days.
16273955|NCT00835029|Drug|Clotrimazole troches|The troche group will be asked to dissolve it in the mouth according to the manufacture instructions five times a day after removal of the denture, for 14 days.
16273956|NCT00835016|Behavioral|Early psychosocial stimulation (LTP)|Learning through Play (LTP) groups will be conducted weekly for the first eight sessions and two fortnightly sessions. Parenting issues will be discussed with the mothers and play activities will be demonstrated with the children using LTP and home made materials.
16273957|NCT00835003|Procedure|Elective caesarean section|Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)
16273958|NCT00835003|Procedure|Elective caesarean section|Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
16273959|NCT00834990|Drug|divalproex sodium|delayed-release 500 mg tablet
16273960|NCT00834990|Drug|Depakote®|delayed-release 500 mg tablet
16273961|NCT00834977|Drug|Amlodipine-benazepril 10 mg-20 mg capsules|1 x 10-20 mg
16273962|NCT00834977|Drug|Lotrel® 10 mg-20 mg capsule|1 x 10-20 mg
16273963|NCT00834964|Drug|Venlafaxine 25 mg Tablets|1 x 25 mg, single-dose fasting
16273965|NCT00834951|Radiation|Low dose total body irradiation|Low dose total body irradiation is given 3 weeks after the end of chemo-immunetherapy in the form of 4 daily fractions 0.2 Gy per fraction to be repeated after 2 weeks of rest
16273966|NCT00834938|Other|No intervention|No intervention
16273967|NCT00834925|Drug|low dose diltiazem|Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes
16273968|NCT00834912|Drug|Tramadol hydrochloride|1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
16273969|NCT00834912|Drug|Tramadol HCl|1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
16273970|NCT00834912|Drug|Tramadol HCl|1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
16273971|NCT00834899|Drug|Eptifibatide|Patients randomized to eptifibatide will receive two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
16273972|NCT00834899|Drug|Placebo|Patients randomized to the placebo arm will receive a saline solution delivered at a volume and rate identical to that of the active drug.
16273973|NCT00834886|Dietary Supplement|Melatonin|Capsules, 3 mg, once every night
16273974|NCT00834886|Other|Bright light|Bright light therapy 10.000 lux by Miljølys AS
16273975|NCT00834886|Other|Placebo red light|Red light 400 lux as placebo light
16273976|NCT00834886|Other|Placebo capsule|Capsules containing 3 mng rice flour, once every night
16273977|NCT00834873|Drug|Carvedilol 25 mg tablets|1 x 25 mg
16273978|NCT00834873|Drug|COREG® 25 mg tablets|1 x 25 mg
16273979|NCT00834860|Drug|peginterferon alpha-2a and ribavirin|They received peginterferon alpha-2a (180 μg/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period.
16273980|NCT00834847|Drug|pravastatin|40 mg tablet
16273981|NCT00834847|Drug|Pravachol®|40 mg Tablet
16273982|NCT00834834|Drug|Fluoxetine|Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.
16273983|NCT00834834|Behavioral|DBT|One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
16273984|NCT00834834|Drug|Citalopram|Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.
16273985|NCT00834821|Behavioral|Parent Focused Training (PFT)|PFT will involve parenting skills training supplemented with a phone session between a therapist and teacher to cover ADHD, inattentive type. This intervention will include ten 90-minute parent group training sessions and up to five individual sessions with the study therapist.
16273986|NCT00834821|Behavioral|Child Life and Attention Skills (CLAS) Program|CLAS will involve parenting skills training adapted for ADHD, inattentive type; child life skills training; and teacher consultation. This intervention will include ten 90-minute parent group training sessions; ten 90-minute child group training sessions; up to five individual family sessions with the study therapist; and up to six 30-minute sessions with the teacher, parent, and therapist.
16273987|NCT00834808|Drug|Tramadol HCl|One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.
16273988|NCT00834795|Drug|Carvedilol 25 mg tablets|1 x 25 mg
16273989|NCT00834795|Drug|COREG® 25 mg tablets|1 x 25 mg
16273990|NCT00834782|Procedure|IOP measurement|Measuring IOP
16273991|NCT00834756|Drug|Azithromycin 600 mg Tablet|1 x 600mg, single-dose fasting
16273992|NCT00834756|Drug|Zithromax® 600 mg Tablet|1 x 600mg, single-dose fasting
16273993|NCT00834743|Drug|Glucophage® XR 750 mg Tablets|1 x 750 mg, single-dose fasting
16273994|NCT00834743|Drug|Metformin ER 750 mg Tablets|1 x 750 mg, single-dose fasting
16273995|NCT00834730|Drug|N2O gas vs ketamine|Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
16273996|NCT00834717|Drug|Granisetron hydrochloride 1 mg tablets|2 x 1 mg, single dose fasting
16273997|NCT00834717|Drug|Kytril® 1 mg tablets|2 x 1 mg, single dose fasting
16273998|NCT00834704|Drug|PEGPH20|PEGylated recombinant human hyaluronidase
16273999|NCT00834678|Drug|bendamustine|100 or 120 mg/m2 IV on days 1 and 2
16274000|NCT00834678|Drug|erlotinib|100 or 150 mg po on days 5 - 21 of each 28 day cycle
16274001|NCT00834678|Drug|Maintenance erlotinib|150 mg po daily (days 1 - 28 of 28 day cycle)
16274002|NCT00834665|Biological|hTERT vaccine, GM-CSF, PCV, T cell infusion|hTERT vaccine (multi-peptide vaccine), Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion
16274003|NCT00834665|Biological|GM-CSF, PCV, T cell infusion|Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion
16274004|NCT00834652|Drug|Sertraline|50 mg once a day, which may be increased to 200 mg once a day
16274005|NCT00834652|Drug|Metformin|Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily
16274006|NCT00834639|Drug|divalproex sodium|delayed-release 500 mg tablet
16274007|NCT00834639|Drug|Depakote®|delayed-release 500 mg tablet
16274008|NCT00834626|Procedure|Ileal Interposition with Sleeve Gastrectomy|Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
16274009|NCT00834613|Drug|Glucophage® XR 750 mg Tablets|1 x 750 mg, single-dose fed
16274010|NCT00834613|Drug|Metformin ER 750 mg Tablets|1 x 750 mg, single-dose fed
16274011|NCT00834600|Drug|olmesartan, hydrochlorothiazide, amlodipine|hydrochlorothiazide (HCTZ) 25mg OD, increased to 50 mg OD at 3 weeks. Olmesartan 20 mg OD, to be increased to 40 mg at 3 weeks. Amlodipine 5 mg, may be added at 6 weeks, if BP >140 mmHg
16274012|NCT00834600|Drug|hydrochlorothiazide (HCTZ) or olmesartan|HCTZ 25 mg, increasing to 50 mg at 3-4 weeks or Olmesartan 20 mg, increasing to 40 mg at 3-4 weeks. If blood pressure >140/90 mmHg at 6 weeks, amlodipine 5 mg may be added
16274013|NCT00834587|Drug|5 mg/500 mg METAGLIP™ Tablets|1 x 5 mg/500 mg, single-dose non-fasting
16274014|NCT00834587|Drug|5 mg/500 mg Glipizide Metformin Hydrochloride Tablets|1 x 5 mg/500 mg, single-dose non-fasting
16274015|NCT00834574|Drug|Cefdinir for oral suspension 250 mg/5mL|1 x 250 mg/5mL, single dose fasting
16274016|NCT00834574|Drug|OMNICEF® for oral suspension 250 mg/5mL|1 x 250 mg/5mL, single dose fasting
16274017|NCT00834561|Drug|Lamotrigine|200 mg Tablet
16274018|NCT00834561|Drug|Lamictal®|200 mg Tablet
16274019|NCT00834548|Procedure|Whole body magnetic resonance angiography (WB-MRA)|WB-MRA will be performed once in each patient.
16274020|NCT00834535|Drug|Cefdinir Capsules 300 mg|1 x 300 mg, single-dose non-fasting
16274021|NCT00834535|Drug|OMNICEF® Capsule 300 mg|1 x 300 mg, single-dose non-fasting
16274022|NCT00834522|Drug|Granisetron hydrochloride 1 mg tablets|2 x 1 mg, single dose non-fasting
16274023|NCT00834522|Drug|Kytril® 1 mg tablets|2 x 1 mg, single dose non-fasting
16274024|NCT00834509|Device|CPAP|Use CPAP for 4-6 weeks as clinically prescribed.
16274025|NCT00834496|Procedure|Liver biopsy|percutaneous liver biopsy
16274026|NCT00834483|Device|Knotless suture for wound closure|Angiotech Quill SRS
16274027|NCT00834483|Device|Layered traditional wound closure (monocryl)|Layered traditional wound closure (monocryl)
16274028|NCT00834470|Drug|Atropine|Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
16274029|NCT00834457|Drug|abacavir/3TC/zidovudine|continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
16274030|NCT00834457|Drug|abacavir /3TC plus ritonavir boosted lopinavir|fixed dose abacavir 600mg/3TC 300mg one tablet po QD for 96 weeks plus fixed dose ritonavir 33.3mg/lopinavir 133.3mg four tablets po QD for 96 weeks
16274031|NCT00834444|Drug|Famciclovir 500 mg Tablets|1 x 500 mg, single-dose fasting
16274032|NCT00834444|Drug|Famvir® 500 mg Tablets|1 x 500 mg, single-dose fasting
16274033|NCT00834431|Drug|Famciclovir 500 mg Tablets|1 x 500 mg, single-dose fasting
16274034|NCT00834431|Drug|Famvir® 500 mg Tablets|1 x 500 mg, single-dose fasting
16274035|NCT00834418|Drug|Leflunomide 20 mg Tablets|1 x 20 mg, single-dose fasting
16274036|NCT00834418|Drug|ARAVA™ 20 mg Tablets|1 x 20 mg, single-dose fasting
16274037|NCT00834405|Drug|ARAVA® 20 mg tablets|1 x 20 mg, single-dose non-fasting
16274038|NCT00834405|Drug|Leflunomide 20 mg Tablets|1 x 20 mg, single-dose non-fasting
16274039|NCT00834392|Behavioral|Exercise|Walking exercise
16274040|NCT00834379|Drug|pravastatin sodium|40 mg Tablet
16274041|NCT00834379|Drug|Pravachol®|40 mg tablet
16274042|NCT00834366|Drug|Tramadol HCl|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.
16274043|NCT00834353|Drug|ATT|
16274044|NCT00834340|Drug|Glimepiride 4 mg Tablets|1 x 4 mg, single-dose fasting
16274045|NCT00834340|Drug|AMARYL® 4 mg Tablets|1 x 4 mg, single-dose fasting
16274046|NCT00834327|Drug|aplindore MR tablets or Placebo|aplindore MR tablets administered QD for about 4 weeks
16274047|NCT00834314|Procedure|Vacuum-Pack-technique for temporary abdominal closure|"Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: Temporary Closure of Open Abdominal Wounds - the Vacuum Pack (see citations)."
16274048|NCT00834314|Procedure|Abdominal-dressing-technique for temporary abdominal closure|Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/#
16274049|NCT00834301|Dietary Supplement|Oral Multivitamin|Oral Multivitamin
16274050|NCT00834288|Drug|Tramadol HCl|1x200 mg Tramadol HCl OAD tablet daily
16274051|NCT00834288|Drug|Tramadol HCl|1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
16274052|NCT00834275|Drug|Cefadroxil 500 mg Capsules|1 x 500 mg
16274053|NCT00834275|Drug|DURICEF® capsules 500 mg|1 x 500 mg
16274054|NCT00834262|Drug|biphasic insulin aspart 30|Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16274055|NCT00834262|Drug|biphasic insulin aspart 50|Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16274056|NCT00834262|Drug|biphasic insulin aspart 70|Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16274057|NCT00834249|Drug|Venlafaxine 25 mg Tablets|1 x 25 mg, single-dose fasting
16274058|NCT00834249|Drug|Effexor® 25 mg Tablets|1 x 25 mg, single-dose fasting
16274059|NCT00834236|Other|normal subject|biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
16274060|NCT00834236|Other|gastric cancer|biomarker in gastric juice, e.g., alpha 1-antitrypsin
16274061|NCT00834223|Device|Aquashunt|A shunt which is implanted into the suprachoroidal space.
16274062|NCT00834210|Drug|Dapsone|Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
16274063|NCT00834210|Drug|Tazarotene|Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
16274064|NCT00834197|Drug|Mirtazapine 15 mg (Orally Disintegrating) Tablets|1 x 15 mg, single-dose non-fasting
16274065|NCT00834197|Drug|REMERON SolTab® 15 mg Orally Disintegrating Tablets|1 x 15 mg, single-dose non-fasting
16274066|NCT00834184|Drug|nikkomycin Z|"Multiple rising doses. Doses packaged on a unit dose basis in 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.
~250 mg BID (n=6) vs Placebo capsule BID (n=2), 500 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg TID (n=6) vs Placebo capsule TID (n=2) At least 4 subjects complete lower dose before randomization includes next higher dose, thus there are 4 arms for active intervention and corresponding placebos."
16274067|NCT00834171|Drug|Loteprednol etabonate ophthalmic suspension 0.5%|Apply one to two drops of Loteprednol etabonate ophthalmic suspension 0.5% into the conjunctival sac as prescribed by your physician
16274068|NCT00834171|Drug|Loteprednol etabonate (0.5%) and tobramycin (0.3%).|Apply one or two drops of Loteprednol etabonate (0.5%) and tobramycin (0.3%) into the conjunctival sac as prescribed by your physician.
16274069|NCT00834158|Procedure|TACE|1 time
16274071|NCT00834145|Device|A mechanical compression pump|Patients in the experimental arm will receive a NormaTec pump which will be used twice daily during hospitalization and once daily on an ambulatory basis. A cuff is placed over the leg and a pneumatic system automatically compresses the leg according to predefined parameters of pressure, time etc.
16274072|NCT00834132|Drug|Azithromycin 600 mg Tablet|1 x 600mg, single-dose fed
16274073|NCT00834132|Drug|Zithromax® 600 mg Tablet|1 x 600mg, single-dose fed
16274074|NCT00834119|Drug|Mometasone furoate|Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
16274075|NCT00834119|Drug|Mometasone furoate|Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician
16274076|NCT00834106|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.
16274077|NCT00834106|Biological|Comparator: placebo (unspecified)|Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.
16274078|NCT00834093|Biological|Epstein-Barr Virus Specific Immunotherapy|Two infusions given fourteen days apart, with a possible third infusion given 8 weeks later.
16274079|NCT00834080|Drug|Medisorb naltrexone 380 mg|Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
16274080|NCT00834067|Drug|Moexipril HCl/hydrochlorothiazide 15/25 mg tablets|1 x 15/25 mg
16274081|NCT00834067|Drug|UNIRETIC® 15/25 mg tablets|1 x 15/25 mg
16274082|NCT00834054|Procedure|Double-lung transplantation|Double-lung transplanted patients
16274083|NCT00834041|Drug|Aliskiren 3.125 mini-tablets|Oral mini-tablets (3.125 mg) of aliskiren once each morning
16274084|NCT00834015|Other|Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial|combined strength and aerobic training group
16274085|NCT00834002|Biological|injection of antigen-loaded cultured dendritic cells|intradermal injection of WT1-RNA-electroporated autologous dendritic cell vaccine (therapeutic cell vaccine)
16274086|NCT00833989|Drug|GSK249320|I.V. infusion
16274087|NCT00833989|Drug|PLACEBO|Placebo
16274088|NCT00833976|Drug|Lovaza|4 grams per day
16274089|NCT00833963|Drug|Trastuzumab|Participants will receive trastuzumab as determined by their treating physicians' standards of care.
16274090|NCT00833963|Drug|Pertuzumab|Participants will receive pertuzumab as determined by their treating physicians' standards of care.
16274091|NCT00833963|Drug|Ado-Trastuzumab Emtansine|Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
16274092|NCT00833950|Device|Phase Out treatment in pure tone tinnitus patients|Phase Out treatment: 30 min 3x/w during 6 weeks
16274093|NCT00833937|Drug|Zolpidem 10 mg tablets|1 x 10 mg
16274094|NCT00833937|Drug|AMBIEN® 10 mg tablets|1 x 10 mg
16274095|NCT00833924|Device|Zenith(R) Low Profile AAA Endovascular Graft|The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
16274096|NCT00833911|Drug|Tramadol Once A Day|
16274097|NCT00833898|Device|Paced respiration as part of PEPRR|The FDA approved RESPeRATE™ is the size of a portable compact disk (CD) player with a visual display, an elastic belt-type respiratory sensor, and a set of headphones. During a relaxation session, the device analyzes respiratory pattern of the subject and creates a melody of pleasant tones selected by the subject (one for inhalation and one for exhalation). The subjects can observe a cartoon figure on the screen of the device that indicates their inhalation and exhalation. The subject synchronizes their breathing to these tones as the exhalation tone is gradually increased in duration with a target of less than 10 breaths/minute. Subjects were encouraged to use RESPeRATE 3-5 times a week for 20 minutes.
16274098|NCT00833898|Behavioral|PEPRR|PEPRR consist of 8 sessions, each lasting approximately 60min. The first 4 sessions are weekly, followed by biweekly mtgs for the remaining 4 sessions. Sessions begin the week that the patient receives the transfusion of donor cells. Session 1-4 are conducted at the hospital where the patients receive their transplant. Once discharged from the hospital, sessions will be conducted at the outpatient BMT clinic to coincide with patients' post-transplant visits. Sessions are devoted to a separate topic with the goal of assisting the caregiver in development & application of various stress-mgmt techniques such as effective problem-solving, identifying & challenging cognitive distortions, relaxation techniques, coping skills training, effective use of social support & goal setting.
16274099|NCT00833885|Device|Masks|Wearing of surgical masks
16274100|NCT00833885|Device|Masks & hand hygiene|Wearing of surgical masks and intensified hand washing
16274101|NCT00833885|Other|Control|General information about virus transmission in households and basic means to prevent it
16274102|NCT00833872|Drug|LEO 22811|First-in-man
16274103|NCT00833872|Drug|placebo solution|
16274104|NCT00833859|Drug|GTX (gemcitabine, docetaxel and capecitabine)|GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
16274105|NCT00833859|Radiation|stereotactic body radiation therapy|stereotactic body radiation therapy (SBRT) 25
16274106|NCT00833833|Drug|Pomalidomide|1 mg, 2 mg, and 5 mg capsules for oral administration packaged in bottles containing a 21-day supply
16274107|NCT00833833|Drug|Dexamethasone|oral dexamethasone
16274108|NCT00833833|Drug|Aspirin|As prophylactic anti-thrombotic treatment, all participants were given aspirin 81-100 mg daily (commercial supply) unless contraindicated. If aspirin was contraindicated, participants were given another form of anti-thrombotic therapy according to hospital guidelines or physician preference.
16274109|NCT00833820|Procedure|Real rTMS of the brain|Repetitive transcranial magnetic stimulation will be performed using a focal coil held over motor cortex on each hemisphere. Stimulation protocol used will be the cTBS in which three pulses of stimulation are given at 50 Hz, repeated every 200 ms for a total of 300 pulses delivered over the right motor cortex. The stimulus intensity will be set at 80% of Action Motor Threshold.
16274216|NCT00832871|Drug|Mifepristone|Mifepristone 200 mg will be administered orally
16274217|NCT00832845|Behavioral|CBSST plus treatment as usual|Patients will receive CBSST in addition to their regular treatment for 36 weeks.
16274110|NCT00833820|Procedure|Sham rTMS of the brain|Sham repetitive transcranial magnetic stimulation will be performed using the same stimulator connected to the placebo butterfly coil MCF-P-B-65 which has no stimulating effect on the cortex but produces similar auditory and tactile sensations as the active coil. The site of stimulation and the number of stimuli will be identical to those used for the active magnetic rTMS.
16274111|NCT00833807|Drug|Nab-Paclitaxel (Abraxane)|"Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.
~Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days."
16274112|NCT00833794|Drug|Tramadol Once a day|
16274113|NCT00833794|Drug|Placebo|
16274114|NCT00833781|Biological|mRNA-transfected autologous dendritic cells|Injections will be administered intradermally at weeks 0, 2, 6 and 10.
16274115|NCT00833781|Biological|autologous dendritic cells with no mRNA transfection|Injections will be administered intradermally at weeks 0, 2, 6 and 10.
16274116|NCT00833768|Drug|Sevelamer carbonate|800mg tablets to be taken orally with meals three times per day
16274117|NCT00833768|Drug|Placebo for sevelamer carbonate|Placebo tablets to be taken orally with meals three times per day
16274118|NCT00833755|Drug|Ketamine|To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
16274119|NCT00833755|Drug|Placebos|To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
16274120|NCT00833742|Behavioral|Intensive Short-term Dynamic Psychotherapy|A brief psychotherapy format
16274121|NCT00833729|Drug|etanercept|50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
16274122|NCT00833716|Drug|semaglutide|10 mg/mL of semaglutide solution for s.c. injection, single dose
16274123|NCT00833703|Drug|Clopidogrel|"Form: reconstituted solution using Clopidogrel powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
16274124|NCT00833703|Drug|placebo|"Form: reconstituted solution using matching placebo powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
16274125|NCT00833690|Drug|Placebo|500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms
16274126|NCT00833690|Drug|inosine|500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL
16274127|NCT00833690|Drug|inosine|500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL
16274128|NCT00833677|Behavioral|Chinese Coping Skills Training|Six-week group behavioral intervention: Chinese Coping Skills Training
16274129|NCT00833664|Drug|Terbinafine HCl 250mg tablets|1 x 250 mg
16274130|NCT00833664|Drug|Lamisil® 250 mg Tablets|1 x 250 mg
16274131|NCT00833638|Drug|Placebo|One tablet orally daily
16274132|NCT00833638|Drug|Tadalafil|Orally once daily
16274133|NCT00833625|Procedure|PET/CT (FDG PET/CT)|PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation).
16274134|NCT00833625|Other|Biomarker Testings|Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.
16274135|NCT00833612|Device|Counterpulsation with IAB|IABC pre-reperfusion PCI
16274136|NCT00833599|Drug|NIRFLI with ICG|We conduct Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic trafficking in subjects. We seek to use the resulting phenotypes acquired in normal and diseased patients to correlate to mutations of specific genes reported to be associated with lymphatic development.
16274137|NCT00833586|Drug|Terbinafine HCl 250mg tablets|1 x 250 mg
16274138|NCT00833586|Drug|Lamisil® 250 mg Tablets|1 x 250 mg
16274139|NCT00833560|Drug|Cyclophosphamide|In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.
16274140|NCT00833560|Drug|Bortezomib|Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).
16274141|NCT00833560|Drug|Dexamethasone|Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).
16274142|NCT00833547|Drug|eszopiclone|3 mg of eszopiclone at bedtime on two consecutive nights
16274143|NCT00833547|Drug|placebo|Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights
16274144|NCT00833534|Biological|rituximab|Given IV
16274145|NCT00833534|Drug|lenalidomide|Given orally
16274146|NCT00833521|Drug|Zolpidem 10 mg tablets|1 x 10 mg
16274147|NCT00833521|Drug|AMBIEN® 10 mg tablets|1 x 10 mg
16274148|NCT00833508|Other|Cardiopulmonary exercise testing|Cardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold.
16274149|NCT00833495|Drug|Prednisolone Acetate 0.12% (Pred Mild®)|Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.
16274150|NCT00833495|Drug|FOV1101-00|This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.
16274151|NCT00833495|Drug|Prednisolone Acetate 1% (Pred Forte®)|PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.
16274152|NCT00833495|Drug|Placebo|The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.
16274153|NCT00833482|Drug|Voriconazole|Treatment A: Participants with functional CYP2C19 alleles (EM) received oral tablets of voriconazole, 400 mg, twice daily (BID), on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a light meal. Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
16274154|NCT00833482|Drug|Atazanavir|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Treatment B in participants who were poor metabolizers of CYP2C19 (PMs): PM participants received oral tablets of atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
16274155|NCT00833482|Drug|Ritonavir|"Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
~Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30. Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal."
16274156|NCT00833469|Drug|Escitalopram|Once daily by mouth
16274157|NCT00833443|Drug|Bupropion|Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
16274158|NCT00833417|Drug|Vismodegib 150 mg|Vismodegib 150 mg was provided in hard gelatin capsules.
16274159|NCT00833404|Drug|Nicotine transdermal patch|8-week nicotine patch regimen (21mg/day during week 1-4, 14mg/day during week 5-6, and 7mg/day during week 7-8).
16274160|NCT00833391|Drug|open label|This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.
16274161|NCT00833378|Drug|Eltrombopag|Eltrombopag 100 mg single oral dose
16274162|NCT00833378|Drug|Lopinavir/Ritonavir|Lopinavir/Ritonavir 400/100 mg oral dose given twice a day for 14 days
16274163|NCT00833378|Drug|Eltrombopag and Lopinavir/Ritonavir|Elrombopag 100 mg single oral dose and Lopinavir/Ritonavir 400/100 mg oral dose given in the AM and PM
16274164|NCT00833365|Drug|Ibuprofen|Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose
16274165|NCT00833365|Drug|Ibuprofen|Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
16274166|NCT00833352|Device|CRT-D Therapy|Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
16274167|NCT00833339|Drug|mifepristone|600 mg/day x 1 week
16274168|NCT00833339|Drug|placebo|placebo
16274169|NCT00833326|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|multiple dose, escalating
16274170|NCT00833326|Drug|Docetaxel, mitotic inhibitor; intravenous|multiple dose, single schedule
16274171|NCT00833326|Drug|Prophylactic growth factors; subcutaneous|standard of care
16274172|NCT00833313|Procedure|Atrial biopsy|Biopsy of left atrial free wall and possibly left atrial appendage
16274173|NCT00833300|Drug|Haloperidol|"2.5 mg-10 mg IV q6h for 24 hours and 2.5 mg-5 mg IV prn, up to 40mg in 24 hours.
~Reassess in 24 hours.
~Delirium absent - Continue dose for 24 hours then discontinue.
~Delirium present - Increase dose 5 mg-10 mg IV q6h for 24 hours and 2.5 mg-5 mg IV prn, up to 40 mg in 24 hours.
~Reassess in 24 hours.
~Delirium absent - Continue dose for 24 hours then discontinue.
~Delirium present - Discontinue current drug therapy and select one of:
~Quetiapine up to 100 mg/day
~Risperidone up to 6 mg/day
~Loxapine up to 50 mg/day
~Methotrimeprazine up to 75 mg/day
~Reassess in 24 hours.
~Delirium absent - Continue for 24 hours then discontinue.
~Delirium present - Treatment at discretion of attending physician."
16274174|NCT00833300|Drug|Olanzapine|"2.5 mg-10 mg po/ng/og bid and 2.5 mg po/ng/og prn, up to 20 mg in 24 hours.
~Reassess in 24 hours.
~Delirium absent - Continue dose for 24 hours then discontinue.
~Delirium present - Increase dose 5 mg-10 mg bid and 2.5 mg po/ng/og prn, up to 20 mg in 24 hours.
~Reassess in 24 hours.
~Delirium absent - Continue dose for 24 hours then discontinue.
~Delirium present - Discontinue current drug therapy and select one of:
~Quetiapine up to 100 mg/day
~Risperidone up to 6 mg/day
~Loxapine up to 50 mg/day
~Methotrimeprazine up to 75 mg/day
~Reassess in 24 hours.
~Delirium absent - Continue for 24 hours then discontinue.
~Delirium present - Treatment at discretion of attending physician."
16274175|NCT00833274|Behavioral|computerized test|Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white.
16274176|NCT00833261|Drug|cetuximab|cetuximab
16274177|NCT00833261|Drug|cisplatin|cisplatin
16274178|NCT00833261|Radiation|intensity-modulated radiation therapy|IMRT
16274179|NCT00833261|Drug|Nab-Paclitaxel|Nab-Paclitaxel
16274218|NCT00832845|Behavioral|Treatment as usual (TAU)|Patients will receive their regular treatment for 36 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians.
16274180|NCT00833248|Drug|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
16274181|NCT00833248|Drug|Goserelin|Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
16274182|NCT00833248|Drug|Bicalutamide|On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
16274183|NCT00833235|Other|Artificial Tears|Artificial tears (any brand) may be used to treat dry eye symptoms.
16274184|NCT00833209|Procedure|PET (withdrawal)|3 (18F)FDG-PET (before withdrawal, 3 months, 1 year), 2 MRI (before withdrawal, 1 year), will take the Iowa Gambling Task Test(before withdrawal) and will answer questionnaires measuring psychological dimensions (before withdrawal, 3 months, 1 year)
16274185|NCT00833209|Procedure|Imaging|2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
16274186|NCT00833209|Procedure|Imaging|1 MRI ; Iowa Gambling Task test and questionnaires.
16274187|NCT00833183|Drug|MAL|80 mg/g cream one administration with incubation for 90 minutes
16274188|NCT00833157|Drug|glucosamine sulphate|Subjects are administered glucosamine-sulphate tablets of 500 mg * 3 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks.
16274189|NCT00833157|Drug|ibuprofen|Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks
16274190|NCT00833157|Drug|placebo|Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks
16274191|NCT00833131|Radiation|Short course of radiotherapy|5 x 5 Gy and afer one week interval consolidating chemotherapy of 3 courses of FOLFOX4
16274192|NCT00833131|Radiation|Radiochemotherapy|28 x 1,8 Gy with simultaneous neoadjuvant chemotherapy: two courses of 5-Fu 325 mg/m2/day i.v. bolus and LV 20 mg/m2/day i.v.-bolus over 5 days given during 1-5 and 29-33 days of radiation. Oxaliplatin is given 50 mg/m2 once a week 5 times during 1, 8, 15, 22 and 29 days of radiation.
16274193|NCT00833118|Procedure|Jaw thrust maneuver (Intubation)|Visualization of Larygnoscopic anatomy during intubation
16274194|NCT00833105|Device|AMES treatment|The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.
16274195|NCT00833092|Dietary Supplement|Sugar Pill|Sugar pill supplementation for 9 weeks
16274196|NCT00833092|Dietary Supplement|magnesium|300 milligrams daily for 8 weeks
16274197|NCT00833079|Drug|Tacrolimus 0.1% manufactured by Taro|Treatment applied as a thin layer to target area twice daily for 14 days
16274198|NCT00833079|Drug|Protopic - Tacrolimus 0.1%|Treatment applied as a thin layer to target area twice daily for 14 days
16274199|NCT00833079|Drug|Tacrolimus Vehicle manufactured by Taro|Treatment applied as a thin layer to target area twice daily for 14 days
16274200|NCT00833066|Biological|gpASIT+TM|entero-coated capsules containing 25µg of gpASIT+TM
16274201|NCT00833066|Biological|Placebo|placebo entero-coated capsules
16274202|NCT00833066|Biological|gpASIT+TM|entero-coated capsules containing 100µg of gpASIT+TM
16274203|NCT00833066|Biological|gpASIT+TM|entero-coated capsules containing 400µg of gpASIT+TM
16274204|NCT00833053|Drug|Infliximab|Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
16274205|NCT00833053|Drug|Infliximab and methotrexate|Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
16274206|NCT00833040|Drug|Sublingual sufentanil NanoTabs™ and placebo NanoTabs™|During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo.
16274207|NCT00833027|Drug|sitagliptin phosphate|Sitagliptin 100 mg/day - tablet for 24 weeks
16274208|NCT00833014|Device|Dynamic Annuloplasty Ring (with option to adjust off-pump)|Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.
16274209|NCT00833001|Device|GYNECARE PROLIFT+M* Pelvic Floor Repair System|Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
16274210|NCT00832988|Other|VentricularAutoCaptureTM & ACapTM Confirm|The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.
16274211|NCT00832962|Genetic|Genotyping|Whole blood sample
16274212|NCT00832962|Other|Usual prophylaxis|Prophylactic anti-RhD
16274213|NCT00832923|Behavioral|PEPAC|"The proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an asthma care toolkit to improve communication around asthma care with the child's primary care provider."
16274214|NCT00832897|Procedure|Corneal collagen crosslinking|"The patients will be submitted to corneal collagen crosslinking, that consists:
~Instillation of riboflavin eyedrop in the cornea for thirty minutes, and after, the patient will stay under the Crosslinking equipment, for more thirty minutes, also receiving riboflavin eyedrop."
16274215|NCT00832884|Drug|Lacosamide|"0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
~0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes"
16274219|NCT00832832|Other|Eyelid closure|Eyelid will be closed after eye drop instillation
16274220|NCT00832832|Other|No intervention will be assigned|No intervention will be assigned to this arm
16274221|NCT00832819|Drug|E7080|Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).
16274222|NCT00832819|Drug|E7080|Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).
16274223|NCT00832819|Drug|Paclitaxel|Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
16274224|NCT00832819|Drug|Carboplatin|Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
16274225|NCT00832806|Behavioral|Extended IVR (integrated voice response technology)|See detailed description
16274226|NCT00832806|Drug|Varenicline (Champix)|See detailed description
16274227|NCT00832806|Behavioral|IVR treatment|See detailed description
16274228|NCT00832780|Radiation|Stereotactic Body Radiation|A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%.
16274229|NCT00832767|Procedure|SILS™ port laparoscopic cholecystectomy|This interventional arm will have a single incision laparoscopic cholecystectomy procedure.
16274230|NCT00832767|Procedure|Four Port Laparoscopic Cholecystectomy|This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.
16274231|NCT00832754|Device|RDT|Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.
16274232|NCT00832754|Other|Clinical Judgement as basis for treatment of malaria with ACT|Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.
16274233|NCT00832728|Other|Standard of Care|Standard hospital protocol for the treatment of acute liver failure
16274234|NCT00832728|Device|ELAD®|ELAD therapy
16274235|NCT00832715|Procedure|EBUS-TBNA|Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.
16274236|NCT00832702|Procedure|Cardiac MRI|CMRI provides unique clinical utilities including excellent soft tissue characterization and contrast, three-dimensionality, quantitation of blood flow, and overall superior temporal and spatial resolution to image vascular and myocardial abnormalities.
16274237|NCT00832689|Drug|Irinotecan and Gemcitabine|
16274238|NCT00832663|Drug|NSAID|Effect of NSAID ingestion on muscle regeneration
16274239|NCT00832663|Drug|placebo|receive placebo
16274240|NCT00832650|Drug|fesoterodine fumarate|8 mg OD for 14 days
16274241|NCT00832650|Drug|placebo|OD for 14 days
16274242|NCT00832650|Drug|solifenacin|10 mg OD for 14 days
16274243|NCT00832637|Drug|Cisplatin|Cisplatin is administered intravenously at 40 mg/m2 on day 1 and day 15, every 28 days. Cisplatin is administered following Gemcitabine. Cisplatin administration should occur with hydration with normal saline at 250 mL/ hour for at least 4 hours before and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.
16274244|NCT00832637|Drug|Erlotinib|100 mg orally daily. For grade 3 or 4 skin rash, erlotinib should be held until resolution of the rash to no more than grade 1 before resumption of erlotinib.
16274245|NCT00832637|Drug|Gemcitabine|Gemcitabine is administered intravenously at 1000 mg/m2 on day 1 and 15, every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine hydrochloride (HCl )(expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
16274246|NCT00832624|Drug|sitagliptin|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
16274247|NCT00832611|Device|Arteriovenous Fistula (ROX AC1)|The percutaneous creation of an arteriovenous fistula.
16274248|NCT00832598|Radiation|[18F]FACBC PET and [18F]FLT PET imaging|[18F]FACBC PET and [18F]FLT PET imaging on 30 patients with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc. Patients with measurable disease on MRI will undergo PET imaging at baseline (prior-to) and after approximately 1 month of treatment.
16274249|NCT00832585|Drug|Alefacept|Alefacept 15mg IM every week for 12 weeks
16274250|NCT00832572|Drug|Ranolazine|Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).
16274251|NCT00832572|Drug|Placebo|Placebo to match ranolazine administered twice a day for 6 weeks
16274252|NCT00832559|Biological|CVA21|1, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals.
16274253|NCT00832546|Drug|Placebo|
16274254|NCT00832546|Drug|Oral NGX426 (Powder in solution)|
16274255|NCT00832520|Drug|Remeron (mirtazapine)|"Mirtazapine 15 mg orally at bed time. Patients with a creatinine clearance < 50% or a bilirubin or transaminases > twice the upper limit of normal will take a 7.5 mg dose.
~Drug Administration: Drug will be administered orally, every day for a period of 8 weeks
~Dose modifications: None"
16274256|NCT00832507|Drug|Cicletanine|Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
16274257|NCT00832507|Drug|Cicletanine Placebo|Placebo to match cicletanine administered orally once daily, followed by active cicletanine in the blinded extension period
16274258|NCT00832494|Drug|DMXAA in combination with carboplatin and paclitaxel|Administered every 21 days
16274259|NCT00832481|Drug|Repaglinide|Repaglinide (NovoNorm®): 0.5 mg/tablet, 1.0 mg/tablet
16274260|NCT00832481|Drug|Metformin|2 mg/tablet Metformin (Glucophage®): 0.5 g/tablet
16274347|NCT00831753|Biological|DTaP IPV HB PRP~T vaccine|0.5 mL, Intramuscular
16274261|NCT00832468|Other|ear acupressure|The ear acupressure that is used involved a 0.3 cm-sized magnetic pellet on a 1 cm size sticky patch (Ching-Ming Co., Taiwan), which was placed on the bilateral ear Shenmen points; each of the points were pressed once a second for one minute (60 times) before sleep every night. The time period of the treatment course was four weeks.
16274262|NCT00832468|Other|sham ear acupressure|The sham ear acupressure that was used involved a 1 cm size sticky patch placed on the bilateral ear Shenmen points. There was no magnetic pellet attached to the sticker and no need to press it.
16274263|NCT00832455|Drug|montelukast sodium|Montelukast 4-5 mg for 12 weeks, oral tablet
16274264|NCT00832442|Drug|Beta blocker|as determined by individual study
16274265|NCT00832442|Other|Placebo|in addition to usual care
16274266|NCT00832429|Procedure|Lymph Node Mapping|Undergo lymph node mapping
16274267|NCT00832429|Procedure|Sentinel Lymph Node Biopsy|Undergo SLN biopsy
16274268|NCT00832429|Drug|Technetium Tc-99m Sulfur Colloid|Given ID
16274269|NCT00832416|Drug|Tramadol Once A Day|One Tramadol Once A Day tablet at randomized dose daily.
16274270|NCT00832416|Drug|Placebo|One Placebo tablet daily.
16274271|NCT00832403|Other|implants of polytetrafluoroethylene in tha nasal fossa|surgical implants of polytetrafluoroethylene in the nasal fossa
16274272|NCT00832390|Drug|sitagliptin phosphate|Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
16274273|NCT00832377|Drug|timolol/dorzolamide combination|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
16274274|NCT00832364|Drug|Acitretin (also called U0279)|Capsules containing 25 mg U0279 taken once a day.
16274275|NCT00832364|Drug|Placebo|Placebo capsules
16274276|NCT00832364|Biological|Etanercept|Injectable Biologic
16274277|NCT00832351|Procedure|Mobilisation|Mobilisation
16274278|NCT00832338|Drug|Docetaxel with Cytoxan|Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
16274279|NCT00832338|Drug|Dexamethasone|Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
16274280|NCT00832325|Behavioral|interview|The doctor and/or one of her trained research study staff will ask the patient about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take (approximately 1-1 ½ hours)to complete. Interviews will be audiotaped and transcribed by a professional transcription service.
16274281|NCT00832325|Behavioral|Focus groups|The patient will participate with 6-8 other adolescent/young adult cancer survivors. The doctor and/or her trained research study staff will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life. It should take about one-and-a-half hour to complete. Focus groups will be audio taped and transcribed by a professional transcription service.
16274282|NCT00832325|Behavioral|Questionnaire|The patient will be asked to participate in three 60-90 minute telephone interviews conducted by the doctor and/or her trained research study staff scheduled at the patient's convenience, the second interview approximately 6-8 months after the first and the last interview approximately 12-16 months after the first. The questionnaire will ask about their experience as an adolescent/young adult cancer survivor, their health and quality of life.
16274283|NCT00832312|Other|ozone-oxygen mixture|10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)
16274284|NCT00832312|Other|placebo (saline)|Injection of 1cc of saline into the knee joint
16274285|NCT00832299|Drug|FOLFOX|6 cycles of neo-adjuvant mFOLFOX6
16274286|NCT00832299|Procedure|total mesorectal excision (TME)|TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.
16274287|NCT00832286|Drug|Ciprofloxacin|Licensed medication, dose: 500 mg every 12 hours for 3 days.
16274288|NCT00832273|Device|ELAD®|liver assist system
16274289|NCT00832247|Genetic|Autologous bone marrow mononuclear cells infusion|At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes
16274290|NCT00832234|Drug|Bortezomib, Dexamethasone, Rituximab|The combination of bortezomib, dexamethasone and rituximab will be administered in five treatment cycles. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle one. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of bortezomib, dexamethasone 40mg IV and rituximab 375mg/m2 IV will be administered. A total of 8 infusions of rituximab will be administered. The administration of bortezomib before rituximab may abrogate the IgM flare phenomenon that occurs frequently after the first course of rituximab.
16274291|NCT00832221|Drug|SEROQUEL XR (quetiapine)|repeated dose of oral tablets, 8 times per subject
16274292|NCT00832221|Drug|SEROQUEL IR (quetiapine)|repeated dose of oral tablets, 4 times per subject
16274293|NCT00832221|Drug|radioligand [11C]raclopride|single dose of iv admin, 5 times per subject
16274294|NCT00832208|Drug|Liposomal amphotericin B (Ambisome)|21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21
16274295|NCT00832208|Drug|Liposomal amphotericin B (Ambisome)|liposomal amphotericin b given intravenously as single dose at 7.5 mg/kg increasing to 10, 12.5 and 15.0mg/kg depending on results of interim analyses.
16274296|NCT00832195|Device|Motion Controlling Running Shoe|Running shoe with thermoplastic mid-foot shank stiffener, denser durometer foam on medial aspect of mid-sole, reinforced heel counter, wider sole-plate, and lateral foam crash-pad.
16274297|NCT00832195|Device|Neutral Running Shoe|Standard running shoe with single density mid-sole foam.
16274298|NCT00832182|Drug|insulin aspart|Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
16274299|NCT00832182|Drug|insulin NPH|Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
16274300|NCT00832169|Drug|AZD1386|1 dose of oral solution
16274301|NCT00832156|Biological|Cultured autologous keratinocytes|The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.
16274302|NCT00832143|Behavioral|Referral Card with one-to-one counseling|A Referral Card (Neonatal Well-Being Card) along with one-to-one counseling to mothers within 48 hours of institutional delivery
16274303|NCT00832130|Device|Manual Mini System|In-office device treatment for meibomian gland dysfunction by a physician
16274304|NCT00832130|Device|iHeat Portable Warm Compress Therapy|At-home daily warm compress therapy
16274305|NCT00832117|Drug|Ixabepilone|Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months
16274306|NCT00832117|Drug|Cisplatin|Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months
16274307|NCT00832117|Drug|Ixabepilone|Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months
16274308|NCT00832117|Drug|Cisplatin|Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months
16274309|NCT00832091|Drug|Thymosin Beta 4|There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
16274310|NCT00832091|Drug|Placebo|There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
16274311|NCT00832078|Device|SpeediCath Compact Male|CH 12 hydrophilic coated intermitten compact catheter
16274312|NCT00832078|Device|Speedicath|CH 12 hydrophilic coated intermittent coated catheter
16274313|NCT00832052|Drug|PF-04447943|Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
16274314|NCT00832052|Drug|PF-04447943|Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
16274315|NCT00832052|Drug|PF-04447943|Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
16274316|NCT00832052|Drug|PF-04447943|Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
16274317|NCT00832052|Drug|PF-04447943|Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days. Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
16274318|NCT00832039|Drug|sodium-selenite|An intravenous bolus of 1000 µg followed by a continuous intravenous infusion of 1000 µg/day until patient is discharged from the ICU but not more than 21 applications à 24 hours.
16274319|NCT00832039|Drug|Placebo|An intravenous bolus of placebo followed by a continuous intravenous infusion with placebo until patient is discharged from the ICU but not more than 21 applications à 24 hours.
16274320|NCT00832039|Procedure|Procalcitonin guided therapy|"Causal therapy of sepsis is guided by applying the following algorithm:
~Day 4: PCT drop from baseline >=50%: no change in causal therapy; PCT drop from baseline <50%: change or optimize antimicrobial therapy, new intervention (i.e. surgery, diagnostics) recommended for source control.
~Day 7, 10, 14: PCT <=1.0 ng/ml: finish antimicrobial therapy; PCT >1.0 ng/ml and PCT drop from last PCT measurement >=50%: finish antimicrobial therapy; PCT >1.0 ng/ml and PCT drop from last PCT measurement <50%: change or optimize antimicrobial therapy, new intervention (i.e. surgery, diagnostics) recommended for source control."
16274321|NCT00832026|Device|Trans Nasal Insufflation (TNI) [nasal canula]|"Trans Nasal Insufflation, or TNI, uses air at flow rates delivered through a small nasal canula to reduce the severity and frequency of sleep apnea events.
~By using TNI we hope to increase the amount of air that the patient can breathe during periods of obstructive sleep disordered breathing."
16274322|NCT00832013|Drug|Propofol|See detailed description
16274323|NCT00832013|Drug|Propofol|See detailed description
16274324|NCT00832000|Drug|Mexiletine|200 mg three times a day; in pill form
16274325|NCT00832000|Drug|Placebo|Placebo three times a day; in pill form
16274326|NCT00831987|Biological|Fluzone®: Influenza virus vaccine 2004-2005 formulation|0.5 mL, Intramuscular
16274327|NCT00831987|Biological|Fluzone®: Influenza virus vaccine 2004-2005 formulation|0.5 mL, Intramuscular
16274328|NCT00831974|Drug|masitinib (AB1010)|3 mg/kg/day
16274329|NCT00831974|Drug|masitinib (AB1010)|6 mg/kg/day
16274330|NCT00831961|Procedure|Conjunctival and nasopharyngeal bacteria cultures|Conjunctival and nasopharyngeal bacteria cultures
16274331|NCT00831948|Genetic|mitochondrial DNA mutations diagnosis|Identification of large-scale mutations of POLG gene by QMPSF in patients with mitochondrial DNA instability.
16274332|NCT00831922|Drug|masitinib (AB1010)|3 mg/kg/day
16274333|NCT00831922|Drug|masitinib (AB1010)|6 mg/kg/day
16274334|NCT00831896|Biological|TAK-701|"Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks
~Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy."
16274335|NCT00831883|Behavioral|Partner-Specific IMB-based HIV risk reduction intervention|5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.
16274336|NCT00831883|Behavioral|Healthy Lifestyle|5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.
16274337|NCT00831857|Other|89Zr-Bevacizumab PET-scan|At baseline, after two weeks of treatment and after 6 weeks of treatment.
16274338|NCT00831844|Biological|cixutumumab|Given IV: Week 1 day 1, 9 mg/kg/dose over 1 hour. Week 2 Day 8, 9 mg/kg/dose over 1 hour. Week 3 Day 15, 9 mg/kg/dose over 1 hour. Week 4 Day 22, 9 mg/kg/dose over 1 hour.
16274339|NCT00831844|Other|laboratory biomarker analysis|Correlative studies
16274340|NCT00831831|Behavioral|Safety planning|See detailed description
16274341|NCT00831792|Drug|TK1258|4 capsules (100 mg/capsules) of TKI 258 by mouth once daily (total of 400 mg of TKI258 per day).
16274342|NCT00831779|Drug|Dapagliflozin|Tablets, Oral, 5 mg, once daily, 12 weeks
16274343|NCT00831779|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 12 weeks
16274344|NCT00831766|Drug|Idarubicin|Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
16274345|NCT00831766|Drug|Cytarabine|Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.
16274346|NCT00831766|Drug|Lenalidomide (Revlimid®)|Lenalidomide as outlined in Phase I and Phase II Treatment Arms.
16274348|NCT00831753|Biological|DTaP-HB-IPV and Haemophilus influenzae type b|0.5 mL, Intramuscular
16274349|NCT00831740|Other|Speech and Language Therapy (SLT)|Participants randomised into the treatment arm will receive early SLT of up to three sessions per week for a maximum duration of 16 weeks. The SLT intervention has been developed by a team of expert Speech and Language Therapists according to 'Best Practice Standards'. The intervention procedure is manualised to allow replicability by other Speech Therapy Departments if it is shown to be effective.
16274350|NCT00831740|Other|Attention Control|Those in the attention control arm of the trial will receive similar levels of contact as those in the SLT arm. However contact will be with an ACT NoW Visitor who has no specific knowledge about communication therapy. They will provide empathy and spend time with the patient, without any input from Speech and Language Therapists.
16274351|NCT00831727|Behavioral|Expressive Writing|Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing
16274352|NCT00831727|Behavioral|Control|Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days
16274353|NCT00831714|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made
16274354|NCT00831714|Drug|Standard care treatment for VTE prophylaxis|Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made
16274355|NCT00831701|Drug|Tamsulosin|0.4 mg Tamsulosin once daily for 21 days
16274356|NCT00831701|Drug|Placebo|One placebo pill per day for 21 days or until stone expulsion
16274357|NCT00831688|Device|Meniett(C) device by MedTronic|pulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube
16274358|NCT00831688|Device|placebo treatment|device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
16274359|NCT00831675|Biological|Influenza Vaccine 2004-2005 Paediatric Formulation|0.25 mL (Day 0 and Day 28), Intramuscular
16274360|NCT00831675|Biological|Influenza Vaccine 2004-2005 Paediatric Formulation|0.25 mL (Day 0 and Day 28), Intramuscular
16274361|NCT00831662|Drug|Diquafosol tetrasodium ophthalmic solution, 2%|One to two drops in each eye QID for 6 weeks
16274362|NCT00831662|Drug|Placebo|One to two drops in each eye QID for 6 weeks
16274363|NCT00831649|Drug|natalizumab|
16274364|NCT00831636|Drug|CP-4055|D1-5 and D8(+2)-12(+2) q4w
16274365|NCT00831636|Drug|CP-4055|IV administration day 1-5 and day 8-12 in a 4 week schedule
16274366|NCT00831623|Radiation|Proton Radiation|3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)
16274367|NCT00831623|Radiation|Proton|As above
16274368|NCT00831610|Procedure|Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.|Surgical removal of the exceeding skin and adiposity of the abdominal wall by one midline vertical fuse and one supra-pubic horizontal fuse. Skin suture without flap undermining and with low tension.
16274369|NCT00831610|Procedure|Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)|Bariatric surgery Plastic surgery Abdominoplasty
16274370|NCT00831597|Drug|bendamustine|120 mg/m2 IV, Days 1, 2 of Cycles 1-6
16274371|NCT00831597|Drug|rituximab|375 mg/m2 IV, Day 1 of Cycles 1-6
16274372|NCT00831545|Drug|Temozolomide|150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).
16274373|NCT00831532|Drug|Dimebon|Dimebon 5mg in healthy controls
16274374|NCT00831532|Drug|Dimebon|Dimebon 5mg in mild hepatic impairment patients
16274375|NCT00831532|Drug|Dimebon|Dimebon 5mg in moderate hepatic impairment patients
16274376|NCT00831532|Drug|Dimebon|Dimebon 5mg in Severe Hepatic Impairment
16274377|NCT00831506|Drug|digoxin|digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.
16274378|NCT00831506|Drug|digoxin|digoxin once daily (0.125 mg QD) for 14 days.
16274379|NCT00831506|Drug|dimebon|Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).
16274380|NCT00831493|Radiation|Chemoradiation (Radiation Therapy)|Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
16274381|NCT00831493|Drug|Vorinostat|Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.
16274382|NCT00831480|Drug|everolimus|everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
16274383|NCT00831467|Biological|CV9103|Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.
16274384|NCT00831441|Drug|Apixaban|Tablets, Oral, 5 mg, twice daily, until study end
16274385|NCT00831441|Drug|Placebo|Tablets, Oral, 0 mg, twice daily, until study end
16274386|NCT00831428|Other|no intervention|this is a screening study, not an interventional study
16274387|NCT00831415|Drug|desvenlafaxine succinate sustained release tablets|25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.
16274388|NCT00831402|Dietary Supplement|Oligobs Maxiode|The 50 women will be follow up with a supplémentation iodized by vitamins of pregnancy strengthened in iodin everything in the course of the pregnancy and during the 3 months post partum (Oligobs Maxiode, 150 mcg / of iodizes, is 2cp a day)
16274389|NCT00831402|Dietary Supplement|controll group|50 women will be studied in the absence of iodized supplémentation(natural history of function thyroïdienne in the course of the pregnancy and in the post partum)
16274390|NCT00831389|Device|Closed Loop|Insulin pump controlled by closed loop unit and algorithm
16274391|NCT00831376|Drug|levosalbutamol|Patients will be asked to take two puffs four times a day for 2 weeks
16274392|NCT00831376|Drug|racemic salbutamol|Patients will be asked to take two puffs four times a day for 2 weeks
16274393|NCT00831376|Drug|placebo|Patients will be asked to take two puffs four times a day for 2 weeks
16274394|NCT00831363|Procedure|minimally invasive total hip arthroplasty|minimally invasive total hip arthroplasty
16274395|NCT00831363|Procedure|standard approach total hip arthroplasty|standard Hardinge approach/traditional transgluteal approach
16274396|NCT00831350|Drug|Ranibizumab|Subjects will receive study medication ranibizumab 0.5mg. Re-treatment will occur monthly through 6 injections
16274397|NCT00831337|Dietary Supplement|VSL3|2 times daily 450 billion live bacteria (in each saschet)
16274398|NCT00831311|Biological|DTaP-IPV-HB-PRP~T|0.5 mL, Intramuscular
16274399|NCT00831311|Biological|DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine|0.5 mL, Intramuscular (right and left thighs, respectively)
16274400|NCT00831298|Other|Analysis of sleep disturbance|Behavioral Questionnaire Sleep Recordings Genetic analysis
16274401|NCT00831285|Dietary Supplement|food product|food product given at one of six visits
16274402|NCT00831272|Drug|naltrexone|50mg/day
16274403|NCT00831272|Drug|Placebo|Placebo
16274404|NCT00831246|Other|chewing gum - Extra Winterfresh|Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
16274405|NCT00831246|Other|Standard Post-Op Care|Patients are given standard post-op care with clear liquid diet as tolerated.
16274406|NCT00831233|Drug|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
16274407|NCT00831233|Drug|Goserelin|Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
16274408|NCT00831233|Drug|Bicalutamide|On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
16274409|NCT00831194|Behavioral|Personalized diet plan and PDA self reporting.|Participants will be given personalized diet plan with a 0.5- 1 lb weight loss/week, based on each person's goals. He/she will also be prompted by a pre programmed PDA to enter dietary lapses and stress inducing events. Saliva samples will be collected as per the study plan.
16274410|NCT00831181|Drug|5-FU|5-FU: continuous infusion via portable pump during all RT (approximately 33 days)
16274411|NCT00831181|Drug|Oxaliplatin|Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)
16274412|NCT00831181|Drug|leucovorin|Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin
16274413|NCT00831181|Procedure|mesorectal excision|mesorectal excision
16274414|NCT00831168|Behavioral|Effects of Active Dissemination|No medical intervention involved. It is purely information based.
16274415|NCT00831155|Drug|Nicotine Patches, Denicotinized Cigarettes|Both groups will receive standard Nicotine Replacement Therapy after the quit date. The Extinction Based group will receive Nicotine patches and denicotinized cigarettes before their quit date
16274416|NCT00831129|Drug|Rosiglitazone|4 mg daily
16274417|NCT00831129|Drug|Placebo Rosiglitazone|1 tab daily
16274418|NCT00831129|Drug|Simvastatin|40 mg daily
16274419|NCT00831116|Device|Intravascular Near Infrared Spectroscopy|Intravascular imaging with a catheter based spectroscopy system.
16274420|NCT00831103|Drug|EPB-348|Treated over seven days
16274421|NCT00831103|Drug|Valacyclovir|Treated over seven days
16274422|NCT00831077|Drug|ORM-14540|i.v.
16274423|NCT00831077|Drug|ORM-12741|i.v.
16274424|NCT00831064|Procedure|colonoscopy bowel prep|PEG, bisacodyl, NaP, PSMC and Mg-citrate
16274425|NCT00831051|Drug|Q8003|One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
16274426|NCT00831051|Drug|Morphine sulfate|One morphine sulfate 12mg IR capsule q6h
16274427|NCT00831051|Drug|Oxycodone HCl|One oxycodone HCl 8mg IR Capsule q6h
16274428|NCT00831051|Drug|Q8003|One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
16274429|NCT00831051|Drug|Morphine sulfate|Two morphine sulfate 3mg IR capsules q6h
16274430|NCT00831051|Drug|Oxycodone HCl 4mg|Two oxycodone HCl 2mg IR Capsules q6h
16274431|NCT00831038|Procedure|Infant Pulmonary Function Tests|Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.
16274432|NCT00831025|Biological|Immunotherapy with modified extract of Olea europaea pollen|Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
16274433|NCT00831025|Biological|Placebo|Placebo for subcutaneous monthly administration
16274434|NCT00831012|Biological|rDEN3delta30/31-7164|A live attenuated, recombinant DEN3 candidate vaccine virus
16274435|NCT00830999|Behavioral|Positive energy balance|Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
16274436|NCT00830999|Behavioral|Energy balance with exercise|Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.
16274437|NCT00830999|Behavioral|Negative energy balance|Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.
16274438|NCT00830999|Behavioral|Negative energy balance with exercise|Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial
16274439|NCT00830999|Behavioral|Energy balance|Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
16274440|NCT00830986|Device|Total Knee Arthroplasty Implant (Scorpio®)|Implantation of a Total Knee Arthroplasty using Conventional Intramedullary Instrumentation
16274441|NCT00830986|Device|Total Knee Arthroplasty Implant (Scorpio®)|Implantation of a Total Knee Arthroplasty using a Computer Assisted Software, without Intramedullary Instrumentation
16274442|NCT00830973|Other|Poor Metabolism Status Follow Up Therapy Considerations|If the patient's CYP2D6 metabolism status is 'poor' then specialist pharmacist will discuss drug therapy alternatives to tamoxifen.
16274443|NCT00830973|Other|CYP2D6 Inhibiting Drugs|If the patient after having a CYP2D6 test has any drugs that inhibit tamoxifen metabolism then specialist pharmacist will contact the physician for alternative drug therapies.
16274444|NCT00830960|Drug|Prasugrel|Oral, daily, 90 days
16274445|NCT00830960|Drug|Clopidogrel|Oral, daily, 90 days
16274446|NCT00830947|Device|OrthoAccel Device|The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
16274447|NCT00830947|Device|Sham Device|Inactive sham device that is held in the mouth for 20 minutes.
16274448|NCT00830934|Procedure|Individual care|The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
16274449|NCT00830934|Procedure|group care|The second treatment group (group care group) will be assigned to weekly group exercise classes, focusing on core stability and strengthening exercises. Classes will last one hour and will be conducted for 4 weeks. In both treatment groups pain scores will be followed up for 1 week post last treatment.
16274450|NCT00830921|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo.
16274451|NCT00830908|Device|HairMax LaserComb|LaserComb to be used 3 times weekly on non-consecutive days, according to User Manual instructions. Use is preferably following a shower, prior to using any styling products on the hair or scalp. Hair may be wet or dry during treatment.
16274452|NCT00830895|Drug|RAD001|RAD001 10mg/day
16274453|NCT00830882|Drug|levosalbutamol|2 puffs four times a day for 2 weeks
16274454|NCT00830882|Drug|racemic salbutamol|2 puffs four times a day for 2 weeks
16274455|NCT00830882|Drug|placebo|2 puffs four times a day for 2 weeks
16274456|NCT00830869|Drug|IXAZOMIB|"All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days.
~The first stage of the study will be initiated at a starting dose of 0.125 mg/m^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established."
16274457|NCT00830856|Drug|Fluconazole|Fluconazole 800mg po qday
16274458|NCT00830856|Drug|Fixed dose - Stavudine, lamivudine and Nevirapine|Initiation within 72 hours of diagnosis of Cryptococcal meningitis.
16274459|NCT00830856|Drug|Fixed dose - Stavudine, Lamivudine, Nevirapine|Delayed initiation of ART defined as 10 weeks after initiation of high dose fluconazole therapy.
16274460|NCT00830843|Drug|Propofol|Propofol(3-4 mg/kg/ora)administrated for 2 hours.
16274461|NCT00830843|Drug|Isoflurane|Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
16274462|NCT00830830|Drug|Hyalgan (sodium hyaluronate)|
16274463|NCT00830804|Drug|Raltegravir|400 mg tablet taken orally twice daily
16274464|NCT00830804|Drug|Darunavir/Ritonavir|800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
16274465|NCT00830791|Drug|MK-0941 20 mg|Two 10-mg tablets of MK-0941 administered as a single oral dose.
16274466|NCT00830791|Drug|MK-0941 5 mg|MK-0941 administered as one single 5-mg tablet.
16274467|NCT00830778|Procedure|Pancreaticojejunostomy|Pancreaticojejunostomy (PJ) reconstruction/anastomosis
16274468|NCT00830778|Procedure|Pancreaticogastrostomy|Pancreaticogastrostomy (PG) reconstruction/anastomosis
16274469|NCT00830765|Drug|Progesterone (OHP17)|100mg of OHP17 or comparable amount of placebo administered by IM injection weekly until either 34 weeks' gestation or delivery has been achieved, whichever occurs first.
16274470|NCT00830765|Drug|Placebo|2cc of placebo liquid formulated by pharmacy personnel at the University of Mississippi Medical Center injected IM weekly until 34 weeks' gestation has been reached or delivery, whichever occurs first.
16274471|NCT00830726|Drug|Pharmacologic and mechanical heart failure treatment|Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.
16274472|NCT00830726|Procedure|Aortic valve replacement|Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.
16274473|NCT00830726|Procedure|Revascularisation in Acute Coronary Syndrome|Standard percutaneous or surgical revascularisation in ACS.
16274474|NCT00830726|Procedure|Revascularisation in chronic stable angina pectoris|Standard percutaneous or surgical revascularisation
16274475|NCT00830713|Procedure|Melanocyte-keratinocyte transplantation procedure (MKTP)|skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.
16274476|NCT00830700|Other|CATMH intervention|This intervention is comprised of 6-tandem-sessions of pharmacotherapy and a behavioral intervention conducted over 4-5 months. The telepsychiatrist makes prescribing decisions during the intervention following consensus guidelines for ADHD treatment. The telepsychiatrist also provides education about how neurobiological deficits of ADHD relate to observed behavioral learning and difficulties. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by therapists at each participating clinic. The therapists are trained and supervised remotely by a telepsychologist . The 6-session behavioral intervention consists of approaches to managing children's behaviors and coordination with schools and other community agencies to advocate for the child.
16274477|NCT00830687|Device|TARGON FN|The Targon FN implant consists of a small side plate with six locking screw ports
16274478|NCT00830674|Drug|Placebo|single dose IV or SC administration
16274479|NCT00830674|Drug|KRN23|Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg
16274480|NCT00830661|Procedure|Ligation of intersphincteric fistula track procedure|Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.
16274481|NCT00830661|Procedure|anal fistula plug|placement of the porcine anal fistula plug as per the instructions for use in product packaging
16274482|NCT00830648|Biological|Live Attenuated Varicella Virus Vaccine|0.5 mL, Subcutaneous
16274483|NCT00830635|Other|educational intervention|
16274484|NCT00830635|Other|informational intervention|
16274485|NCT00830635|Other|internet-based intervention|
16274486|NCT00830635|Other|questionnaire administration|
16274491|NCT00830622|Other|Cell Phone Intervention|Participant receives weekly SMS text messages from the health care provider.
16274492|NCT00830609|Drug|Peginterferon alfa 2 A|Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb>12 g/dL if required over 20 additional weeks (Arm B2)
16274493|NCT00830609|Drug|Peginterferon alfa 2 A, ribavirin + Epo Beta|Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb>12g/dl over 4 or 24 weeks
16274494|NCT00830609|Drug|ribavirin|RBV 1600 mg/day 24 weeks
16274495|NCT00830609|Drug|ribavirin|ribavirin 800 mg/day for 24 weeks
16274496|NCT00830609|Drug|Peginterferon alfa 2|Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks
16274497|NCT00830609|Drug|ribavirin|RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks
16274498|NCT00830596|Other|HVLA-SM|High velocity, low amplitude lumbo-pelvic manipulation
16274499|NCT00830596|Other|LVVA-SM|Low velocity, variable amplitude lumbo-pelvic manipulation
16274500|NCT00830596|Other|Sham Intervention|2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
16274501|NCT00830583|Procedure|blood test|There is only a blood test at the beginning.
16274502|NCT00830570|Other|CYP 2C9 and VKORC1 Testing for Warfarin|Test patients for their warfarin sensitivity and provide this information to their physician authorizing the test.
16274503|NCT00830557|Other|medical chart review|baseline, 12 month and 36 months
16274504|NCT00830557|Other|survey administration|baseline, 6 month, 12 month
16274505|NCT00830557|Other|biospecimen collection|baseline
16274506|NCT00830544|Drug|Neoadjuvant chemotherapy|Docetaxel 75 mg/m2, day 1 Epirubicin 80 mg/m2, day 1 Cyclophosphamide 500 mg/m2, day 1 Navelbine 25 mg/M2 in 250 cc NS over 60 min on day 1 and day 8 Bevacizumab 5 mg/kg in 100 cc NS over 90 min day 1 and day 8 Capecitabine 825 mg/M2 p.o. bid from day 1-14. Trastuzumab
16274507|NCT00830544|Drug|Chemotherapy|Neoadjuvant chemotherapy
16274508|NCT00830544|Drug|Neoadjuvant chemotherapy|Experimental chemotherapy regimen
16274509|NCT00830531|Drug|Bumetanide|Bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy
16274510|NCT00830531|Drug|Normal Saline as Placebo|Normal Saline as placebo for bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy
16274511|NCT00830518|Drug|Alisertib|Alisertib capsules
16274512|NCT00830505|Drug|fluticasone/salmeterol|2 puffs twice a day for 2 weeks
16274513|NCT00830505|Drug|fluticasone|2 puffs twice a day for 2 weeks
16274514|NCT00830492|Drug|clomiphene citrate|100 mg from cycle day 3 through 7
16274515|NCT00830492|Procedure|Ultrasound|cycle day 8
16274516|NCT00830492|Drug|GnRH antagonist|Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).
16274517|NCT00830492|Drug|gonadotopin (HMG)|75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)
16274518|NCT00830492|Drug|buserelin|Buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg.
16274519|NCT00830492|Drug|rFSH|150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.
16274520|NCT00830479|Procedure|Anti-reflux surgery|Open ureteroneocystostomy for correction of vesicoureteral reflux
16274521|NCT00830479|Procedure|Endoscopic injection|Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
16274522|NCT00830466|Drug|Laser and rapamycin versus laser alone|Laser and rapamycin versus laser alone
16274523|NCT00830453|Procedure|Hyperbaric oxygen therapy (HBO2)|60 daily hyperbaric oxygen sessions 1.5 atmospheres absolute, 100% oxygen 60 minutes per session, from door closing to door opening
16274524|NCT00830440|Device|EndoBarrier Device|NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks
16274525|NCT00830440|Behavioral|Diet & Lifestyle Counseling|NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp
16274526|NCT00830427|Drug|PF-00610355|100 mcg, QD, dry powder inhaler
16274527|NCT00830427|Drug|PF - 00610355|600 mcg, QD, dry powder inhaler
16274528|NCT00830427|Other|Placebo|QD, dry powder inhaler
16274529|NCT00830427|Drug|PF - 00610355|300 mcg, QD, dry powder inhaler
16274530|NCT00830414|Drug|medroxyprogesterone acetate|IM Injection
16274531|NCT00830414|Drug|medroxyprogesterone acetate|IM injection
16274532|NCT00830401|Procedure|Treatment of predefined abnormality by hysteroscopic surgery|"Polyp resection with Hysteroscopic scissors or Versapoint
~Resection of myoma with Resectoscope Storz or Versapoint
~Septum resection with Resectoscope Storz or Versapoint
~Resection of adhesions with Hysteroscopic scissors or Versapoint"
16274533|NCT00830401|Drug|Ofloxacinum/Doxycycline|Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
16274534|NCT00830388|Drug|Ketoconazole 2% Foam|Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
16274535|NCT00830375|Drug|Memantine|10-30mg, by mouth, daily
16274536|NCT00830362|Drug|Propranolol|40 mg administered once
16274537|NCT00830362|Drug|Placebo|administered once
16274538|NCT00830349|Drug|Risperidone|1 mg Tablet
16274539|NCT00830349|Drug|Risperidone|1 mg Tablets
16274540|NCT00830336|Drug|Azithromycin|Oral Suspension
16274541|NCT00830336|Drug|Zithromax®|Oral Suspension
16274542|NCT00830323|Drug|oseltamivir + zanamivir|oseltamivir (75mg bd for 5 days, oral) zanamivir (5mg bd for 5 days, inhaled by mouth)
16274543|NCT00830323|Drug|oseltamivir+ amantadine|oseltamivir (75mg bd for 5 days, oral) + amantadine (100mg bd for 5 days, oral)
16274545|NCT00830310|Behavioral|Psychoeducation module|"Individuals will be assigned the psychoeducation module if they are identified as having opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes towards drugs in general, or lack of information about mood stabilizers operationalized as a score of 1 or higher on any of these AMSQ subscales. Additionally, those individuals who are non-adherent/sub-optimally adherent because of stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments will be assigned to participate in the psychoeducation module (ROMI stigma item or complementary/alternative treatment supplemental item)."
16274546|NCT00830310|Behavioral|Substance use module|Individuals will be assigned the substance use module if they endorse the ROMI substance use item or if substance use is identified as problematic on the clinician assessment.
16274547|NCT00830310|Behavioral|Improved communication/rapport with provider module|"Individuals will be assigned the provider communication/rapport module if they are identified as having fear of side effects operationalized as a score of 1 or higher on these AMSQ items. Additionally, those individuals who are non-adherent/suboptimally adherent because of concern regarding change in appearance appearing medicated or who experience side-effect-related distress as identified by the ROMI will be assigned the provider communication module."
16274548|NCT00830310|Behavioral|Medication routines management module|"Individuals will be assigned the medication routines management module if they are identified as having difficulties with medication routines operationalized as a score of 1 or higher on this AMSQ sub-scale, or if they are identified as experiencing outside opposition to medications by the ROMI."
16274549|NCT00830297|Drug|Insulatard (long-acting insulin)|In group No.1 (study arm 1 (=A)), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl.
16274550|NCT00830297|Drug|Conventional|In group No.2 (study arm 2 (=B)), patients will be treated conventionally according to the decisions taken by the physicians on the ward. The following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than twice daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl.
16274551|NCT00830284|Procedure|Recruitment maneuver|"Three types of maneuvers will be performed.
~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.
~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.
~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
16274552|NCT00830271|Device|Vicryl plus and Monocryl plus|closure of skin and subcutaneous tissues
16274553|NCT00830271|Device|wound closure with Vicryl and Monocryl|wound closure skin and subcutaneous tissues
16274554|NCT00830258|Drug|Pravastatin sodium 80 mg tablets|1 x 80 mg
16274555|NCT00830258|Drug|Pravachol® 80 mg tablets|1 x 80 mg
16274556|NCT00830245|Drug|Erlotinib|Erlotinib 150mg/day
16274557|NCT00830232|Device|closed-cell stent (Xact stent)|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this groups was the Xact closed-cell stent. This type of device is rigid device with dense conposition of the nitinol rigns.
~Carotid stenting was used on standard fashion using filters as embolic protection device."
16274558|NCT00830232|Device|Open-cell stent (Acculink carotid)|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.
~Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
16274559|NCT00830219|Drug|Ropinirole HCl 0.25 mg Tablets|1 x 0.25 mg, single dose fed
16274560|NCT00830219|Drug|Requip® 0.25 mg Tablets|1 x 0.25 mg, single dose fed
16274561|NCT00830206|Other|Azithromycin|Oral Suspension
16274562|NCT00830206|Drug|Zithromax®|Oral Suspension
16274563|NCT00830193|Drug|N-acetylcysteine|Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo in 100 cc D5W (pre-CT dose) or 2.5 g of NAC or placebo in 50 cc D5W (post-CT doses).
16274564|NCT00830193|Drug|D5W Placebo|Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo (D5W) in 100 cc D5W (pre-CT dose) or 2.5 g NAC or placebo in 50 cc D5W (post-CT doses).
16274565|NCT00830180|Biological|Anti-NGF AB|Solution for injection, 10 mg, one injection/8 weeks
16274566|NCT00830167|Drug|Placebo|Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
16274567|NCT00830167|Drug|Pregabalin|Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
16274568|NCT00830154|Drug|pagoclone|0.30 mg BID, 0.60 mg BID
16274569|NCT00830154|Other|placebo|placebo
16274570|NCT00830128|Drug|pregabalin (Lyrica)|Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks
16274571|NCT00830115|Drug|Pantoprazole|Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
16274572|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug)
~Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
~Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
~Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)"
16274606|NCT00829881|Drug|Betahistine Hydrochloride|A single betahistine hydrochloride capsule, increasing in dose from 50 mg, to 100 mg, to 200 mg, over 3 weeks
16274607|NCT00829881|Drug|Placebo Capsule|A single placebo capsule
16274608|NCT00829868|Drug|Zaleplon 10 mg Capsules|1 x 10 mg
16274609|NCT00829868|Drug|SONATA® 10 mg capsules|1 x 10 mg
16274573|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)
~Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
~Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
~Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)"
16274574|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
~Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
~Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI)
~Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)"
16274575|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
~Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)
~Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
~Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)"
16274576|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
~Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation)
~Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
~Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)"
16274577|NCT00830102|Drug|fluticasone propionate, formoterol fumarate|"Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI
~Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
~Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug)
~Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)"
16274578|NCT00830089|Drug|Levobupivicaine 0.25%|40mls of 0.25% L-bupivicaine will be injected into the transversus abdominis plane (TAP) under ultrasound guidance - 20mls on either side of the abdomen.
16274579|NCT00830076|Drug|sitagliptin phosphate|Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.
16274580|NCT00830076|Drug|metformin hydrochloride|Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.
16274581|NCT00830076|Drug|Comparator: placebo sitagliptin|Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.
16274582|NCT00830076|Drug|Comparator: placebo metformin|Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.
16274583|NCT00830063|Biological|tanezumab 10 mg|tanezumab 10 mg one dose at weeks 0 and 8
16274584|NCT00830063|Biological|tanezumab 5 mg|tanezumab 5 mg one dose at weeks 0 and 8
16274585|NCT00830063|Drug|naproxen|naproxen 1000 mg daily for 16 weeks
16274586|NCT00830063|Other|placebo|placebo to match tanezumab and naproxen dosing
16274587|NCT00830050|Drug|Naproxen|500 mg BID 7 days
16274588|NCT00830050|Drug|Placebo|BID 7 days
16274589|NCT00830037|Drug|IV Iron|IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
16274590|NCT00830037|Drug|Ferrous Sulfate|Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
16274591|NCT00830024|Drug|Alprazolam Extended-Release 3 mg Tablets|1 x 3 mg, single dose non-fasting
16274592|NCT00830024|Drug|Alprazolam Extended-Release 3 mg Tablets|1 x 3 mg, single dose non-fasting
16274593|NCT00830011|Behavioral|cognitive behavioral therapy|Ten sessions of manualized CBT delivered by a PhD level psychologist
16274594|NCT00830011|Other|standard medical care|any care recommended by physician for treatment of diabetic neuropathy including medication.
16274595|NCT00829998|Drug|Zaleplon 10 mg Capsules|1 x 10 mg, single-dose fasting
16274596|NCT00829998|Drug|Sonata® 10 mg Capsules|1 x 10 mg, single-dose fasting
16274597|NCT00829985|Biological|Glycerinated German Cockroach Allergenic Extract|Concentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved.
16274598|NCT00829985|Biological|Placebo|Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve
16274599|NCT00829959|Behavioral|Questionnaire|1 - 2 questionnaires, lasting 10-15 minutes.
16274600|NCT00829946|Behavioral|Physical activity|Participants in the intervention group were enrolled in two training sessions per week for 12 weeks. The core portion of the training session consisted of 11 strength exercises engaging the major muscle groups, i.e. bench press, shoulder press, leg extension, leg press, leg curl, abdominal crunch, low back extension, arm curl, elbow extension, seated row and lateral pull-down. For each exercise, the participants performed one set of 8-15 repetitions (total of ~ 20s duration) with resting periods of 1-2 min between exercises. The load was gradually increased as the strength of each child improved, i.e. from 20-30% of 6 repetition maximum (6RM) at the start of the program to 50-60% of 6RM at the end. Participants also performed isometric contractions of large muscle groups (6 sets of 3 repetitions each, 20-30s duration per repetition) with their own body weight (for lower body exercises) or barbells (1-3kg) for upper body.
16274601|NCT00829933|Drug|DU-176b tablets|DU-176b tablets taken once daily for up to 12 weeks
16274602|NCT00829933|Drug|Warfarin potassium tablets|Warfarin potassium tablets taken once daily for up to 12 weeks
16274603|NCT00829907|Drug|ORM-12741|Single dose as a capsule, oral administration
16274604|NCT00829894|Drug|Risperidone|1 mg Tablet
16274605|NCT00829894|Drug|Risperidone|1 mg Tablet
16274612|NCT00829829|Other|Placebo|Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
16274613|NCT00829829|Drug|Rilonacept 80 mg|Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
16274614|NCT00829829|Drug|Rilonacept 160 mg|Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
16274615|NCT00829816|Drug|Dimebon|
16274616|NCT00829816|Drug|Placebo|
16274617|NCT00829803|Device|SNAP monitor; Bispectral Index Monitor (BIS Monitor)|Intended to monitor the state of the brain by data acquisition of EEG signals.
16274618|NCT00829790|Drug|Doxycycline Monohydrate|25 mg 5mL oral dose
16274619|NCT00829790|Drug|Doxycycline Monohydrate|25 mg 5 mL dose
16274620|NCT00829777|Drug|6β-Naltrexol escalating doses from 0.05-0.5 mg IV|"Drug: Naloxone 0.1 mg IV/5 minutes to all subjects to determine tolerability to precipitated withdrawal during screening. Those that tolerate withdrawal proceed to Stage 1:
~Drug: Lactulose 10 gm orally plus 3 IV infusions 30 minutes apart of Naloxone 0.1 mg IV and 2 placebo given randomly to all subjects. If tolerated, proceed to 5 additional medication dosing sessions with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo."
16274621|NCT00829764|Drug|Doxycycline Monohydrate|25 mg 5 mL dose
16274622|NCT00829764|Drug|Doxycycline Monohydrate|25 mg 5 mL dose
16274623|NCT00829751|Device|PureVision lenses soaked in ReNu Multiplus|Purevision silicone hydrogel lenses
16274624|NCT00829751|Device|PureVision lenses soaked in OptiFree RePlenish|Purevision silicone hydrogel lenses soaked in OptiFree RePlenish
16274625|NCT00829738|Drug|Pantoprazole|This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).
16274626|NCT00829725|Device|screws-internal fixation|3-4-screws-internal fixation
16274627|NCT00829725|Device|TARGON FN|"The Targon FN implant consists of a small side plate with six locking screw ports. The two distal holes are used to fix the plate to the lateral cortex of the femur with angle stable 4.5 mm cortical screws. The proximal holes allow the implementation of up to four TeleScrews which cross the fracture site. These 6.5 mm screws are dynamic and allow therewith the collapse of the fracture at the femoral neck. The sliding during the collapse occurs within these screws so that a protrusion of the screws in the lateral soft tissue is prevented"
16274628|NCT00829712|Drug|Dexmethylphenidate Hydrochloride|10 mg Tablet
16274629|NCT00829712|Drug|Dexmethylphenidate Hydrochloride|10 mg Tablet
16274630|NCT00829699|Procedure|euinsulinemic euglycemic glucose clamp|euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours
16274631|NCT00829699|Procedure|euinsulinemic hyperglycemic glucose clamp|euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
16274632|NCT00829699|Procedure|Hyperinsulinemic euglycemic glucose clamp|Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
16274633|NCT00829699|Procedure|Hyperinsulinemic hyperglycemic glucose clamp|Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
16274634|NCT00829686|Drug|Septra|(800/125) PO BID X 7 days
16274635|NCT00829673|Drug|Dexmethylphenidate Hydrochloride|10 mg Tablet
16274636|NCT00829673|Drug|Dexmethylphenidate Hydrochloride|10 mg Tablet
16274637|NCT00829660|Drug|Acarbose|The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
16274638|NCT00829660|Drug|Matching Placebo|The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
16274639|NCT00829647|Drug|dasatinib and lenalidomide|dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po
16274640|NCT00829634|Drug|l-methamphetamine|5mg of l-methamphetamine per day throughout the 2 week study
16274641|NCT00829634|Drug|d-methamphetamine|15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
16274642|NCT00829621|Other|75 mmHg suction|Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
16274643|NCT00829621|Other|125 mmHg|Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
16274644|NCT00829608|Biological|Human Papillomavirus Vaccine|0.5 mL of quadrivalent HPV vaccine will be given intramuscularly at three separate intervals. Dose 2 is given 2 weeks after dose 1 and dose 3 is given 4 weeks after dose 1 for a total of 3 doses over 2 months.
16274645|NCT00829595|Biological|23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)|0.5mL intramuscular, one time
16274646|NCT00829582|Drug|"ETI-204, Anthim"|single intravenous infusion of 120, 240 or 360 mg of ETI-204
16274647|NCT00829582|Other|placebo|single intravenous infusion
16274648|NCT00829569|Dietary Supplement|Intralipid +/- Omegaven|"Intralipid®: the 500 ml 20% Intralipid will be infused during a hyperinsulinemic clamp. Infusion rate will increase from 50 to 100 ml/hour the first 30 min and then continue at 100 ml/hour for the next 210 min, infusion duration 240 min (4 hours) in all.
~Intralipid® + Omegaven®: In the 500 ml 20% Intralipid 100 ml will be replaced by 100 ml 10% Omegaven and infused during the hyperinsulinemic clamp as described for Intralipid only. Heparin (0.4 U/kg/min) will be added to both lipid emulsions.
~Content of marine n-3 fatty acids in 100 ml Omegaven will be 1.25-2.82 g EPA and 1.44-3.09 g DHA (seasoning variations of n-3 fatty acids in fish oil)."
16274649|NCT00829556|Device|Integuseal|
16274650|NCT00829543|Procedure|guide-free sacroiliac corticosteroid injection|guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint
16274651|NCT00829530|Drug|Ramipril 10 mg capsule|1 x 10 mg
16274652|NCT00829530|Drug|Altace® 10 mg capsule|1 x 10 mg
16274653|NCT00829517|Other|computer-assisted provision of hormonal contraception|a computer program available at a kiosk will offer women information about and a prescription for hormonal contraception that they can ask their clinician to sign.
16274654|NCT00829517|Other|STI module|computer module available at a kiosk that will encourage women to be screened for chlamydia
16274657|NCT00829491|Behavioral|CVD risk reduction program|Participants will be selected through review of the DH administrative databases or by referral from their primary care provider. After completion of the forms, the navigator and client will discuss potential CVD risk reduction activities and programs available through this program for the client to participate in. Potential activities will include self-monitoring using self-help tools,healthy nutrition and exercise activities, community-based exercise programs using the recreation centers in the community, and referral to the Colorado Quitline for smoking cessation activities. Follow-up questionnaires will be completed at 6 and 12 months after enrollment to assess changes in levels of exercise, dietary patterns, and beliefs and attitudes about behavioral change.
16274658|NCT00829478|Behavioral|Decision Aid for Atrial Fibrillation|Single contact educational session
16274659|NCT00829478|Other|Usual Care|Usual Care
16274660|NCT00829465|Drug|Licartin|Licartin
16274661|NCT00829465|Procedure|Transcatheter arterial chemoembolization|TACE
16274662|NCT00829452|Drug|Ramipril 10 mg capsule|1 x 10 mg
16274663|NCT00829452|Drug|Altace® 10 mg capsule|1 x 10 mg
16274664|NCT00829439|Drug|Levodopa/Carbidopa (4:1)|"Dosages are based on levodopa.
~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
16274665|NCT00829426|Drug|Alprazolam Extended-Release 3 mg Tablets|1 x 3 mg, single dose fasting
16274666|NCT00829426|Drug|Alprazolam Extended-Release 3 mg Tablets|1 x 3 mg, single dose fasting
16274667|NCT00829413|Drug|SonoVue®|SonoVue (2.4 mL)
16274668|NCT00829400|Behavioral|Cognitive Remediation|Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training
16274669|NCT00829400|Behavioral|Nintendo Brain Age|Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training
16274670|NCT00829387|Behavioral|CBT plus standard pharmaceutical care (CBT/SC)|Ten sessions of individual treatment delivered by a doctoral level psychologist.
16274671|NCT00829387|Behavioral|Diabetic Education plus standard pharmaceutical care (ED/SC)|Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
16274672|NCT00829374|Drug|Dimebon|5 mg orally three times daily
16274673|NCT00829374|Drug|Dimebon|20 mg orally three times daily
16274674|NCT00829374|Drug|Placebo comparator|Placebo orally three times daily
16274675|NCT00829361|Other|Telemedicine|Two way site independent audio/video telemedicine system with DICOM.
16274676|NCT00829348|Other|No intervention|60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
16274677|NCT00829348|Behavioral|Short Message Service (SMS)|60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
16274678|NCT00829335|Procedure|IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION|Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.
16274679|NCT00829322|Drug|Modafinil|Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
16274680|NCT00829322|Drug|Placebo|One capsule daily for 14 days, increasing to two capsules daily for 14 days
16274681|NCT00829309|Drug|Pravastatin|80 mg Tablet
16274682|NCT00829309|Drug|Pravastatin|80 mg Tablets
16274683|NCT00829296|Drug|nebivolol|Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
16274684|NCT00829296|Drug|Metoprolol|Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
16274685|NCT00829283|Behavioral|Behavioral Weight Loss|weekly individual sessions for 6 months
16274686|NCT00829283|Behavioral|Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy|weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
16274687|NCT00829283|Drug|Placebo|One pill daily
16274688|NCT00829283|Drug|Sibutramine/Orlistat|Sibutramine 15 mg daily or Orlistat 120mg TID
16274689|NCT00829257|Drug|HFA-BDP|HFA-BDP (Qvar) 100ug 2puff b.i.d
16274690|NCT00829257|Drug|Fluticasone|Fluticasone propionate Accuhaler 250ug b.i.d.
16274691|NCT00829257|Drug|Seretide|Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
16274692|NCT00829244|Drug|GONAL f® prefilled pen|GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only
16274693|NCT00829244|Drug|GONAL f® prefilled pen|GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.
16274694|NCT00829231|Drug|Sorafenib (Nexavar, BAY43-9006)|Mildly Hepatic Impaired Subjects
16274695|NCT00829231|Drug|Sorafenib (Nexavar, BAY43-9006)|Moderately Hepatic Impaired Subjects
16274696|NCT00829231|Drug|Sorafenib (Nexavar, BAY43-9006)|Healthy Subjects
16274697|NCT00829218|Other|Glutamate additive-free diet|All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week.
16274698|NCT00829218|Other|Placebo diet|Juice with nothing added.
16274699|NCT00829205|Biological|filgrastim|
16274700|NCT00829205|Biological|rituximab|
16274701|NCT00829205|Dietary Supplement|Se-methyl-seleno-L-cysteine|
16274702|NCT00829205|Drug|carboplatin|
16274703|NCT00829205|Drug|etoposide|
16274704|NCT00829205|Drug|ifosfamide|
16274705|NCT00829205|Other|laboratory biomarker analysis|
16274706|NCT00829205|Other|pharmacological study|
16274707|NCT00829192|Drug|Afamelanotide (CUV1647)|16 mg subcutaneous implant administered every 60 days
16274708|NCT00829192|Drug|Placebo|Placebo subcutaneous implant administered every 60 days
16274709|NCT00829179|Drug|RhuMab-E25|three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.
16274710|NCT00829166|Drug|Trastuzumab emtansine|Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
16274711|NCT00829166|Drug|Lapatinib|Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
16274712|NCT00829166|Drug|Capecitabine|Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
16274713|NCT00829153|Device|U Clip|Interuppted nitional clips
16274714|NCT00829153|Procedure|Conventional prolene anastomosis|Continuous prolene anastomosis
16274715|NCT00829140|Drug|Placebo|
16274716|NCT00829140|Drug|Lorcaserin 10mg BID|
16274717|NCT00829127|Drug|AZD8075|single dose, oral suspension, on Day 1. Repeated dosing will commence on Day 3 once daily for 14 days. The planned starting dose will be 35 mg with up to 2 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits or the exposure obtained so far in the SAD study.
16274718|NCT00829127|Drug|Placebo|Oral suspension
16274719|NCT00829114|Drug|ETHINYL ESTRADIOL AND LEVOGESTREL|30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
16274720|NCT00829114|Drug|ETHINYL ESTRADIOL AND LEVOGESTREL|30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
16274721|NCT00829088|Drug|AZD2066|1 dose oral solution
16274722|NCT00829075|Drug|r-FSH|
16274723|NCT00829075|Drug|HP-hMG|
16274724|NCT00829075|Drug|r-FSH plus HP-hMG|
16274725|NCT00829062|Device|Continuous glucose glucose sensor- physician ordered|Charts will be reviewed to identify recipients of Missouri Medicaid who receive daily injections to manage their diabetes. Children who have submitted an application for the Medtronic MiniMed insulin pump will be identified by the PI and Medtronic Diabetes. They will be asked to wear a 72 hour continuous glucose monitor. The children who wear the sensor will be asked to keep a daily logbook of their blood sugars, activities, food intake, and insulin doses during this 72 hour period. The families of the children will be provided with a pre-addressed FedEx envelope for them to return the digital recorder and daily logbooks to the PI. The results of the glucose sensor will be downloaded by the PI. The families will be contacted by the PI with the results and treatment recommendations.
16274726|NCT00829049|Drug|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
16274727|NCT00829049|Drug|Adapalene|1 pea-size amount, QD x 16 weeks
16274728|NCT00829036|Device|Wayfinding Prototype|A Wayfinding Prototype is used by subjects to determine any advantages over current standard of rehabilitation.
16274729|NCT00829023|Other|chlorhexidine gluconate and isopropyl alcohol, iodophor and isopropyl alcohol, povidone-iodine scrub and paint|surgical skin preparation solutions
16274730|NCT00829010|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, administered as 3 or 4 doses
16274731|NCT00829010|Biological|Tritanrix-HepB/Hib|Intramuscular injection, 4 doses
16274732|NCT00829010|Biological|measles|Intramuscular injection, 2 doses
16274733|NCT00829010|Biological|Rotarix|Oral, 2 doses
16274734|NCT00829010|Biological|Local OPV|Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
16274735|NCT00828997|Biological|Prevenar vaccination|vaccination with Prevenar vaccine in patients with arthritis
16274736|NCT00828984|Drug|macrogol 3350-based oral osmotic laxative|Given PO
16274737|NCT00828984|Other|Placebo|Given PO
16274738|NCT00828984|Other|Laboratory Biomarker Analysis|Correlative studies
16274739|NCT00828971|Drug|Avelox (Moxifloxacin, BAY12-8039)|Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
16274740|NCT00828971|Drug|Amoxicilline/clavulanic|IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days
16274741|NCT00828958|Drug|Risperidone long-acting injectable|
16274742|NCT00828945|Device|Lipid Self Test|Self test for lipid levels, twice during study period
16274743|NCT00828932|Drug|Lorcaserin|
16274744|NCT00828919|Drug|axitinib|BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial
16274745|NCT00828919|Drug|crizotinib|BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.
16274746|NCT00828906|Drug|DuoTrav|DuoTrav Eye Drops
16274747|NCT00828893|Device|navigation station|navigation station for gestures (carried out under CT) guidance
16274748|NCT00828880|Device|DRX9000|DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period
16274749|NCT00828867|Drug|100 mg GSK investigational drug|
16274750|NCT00828867|Drug|200 mg GSK investigational drug|
16274751|NCT00828867|Drug|400 mg GSK investigational drug|
16274752|NCT00828867|Drug|800 mg GSK investigational drug|
16274753|NCT00828867|Drug|2000 mg GSK investigational drug|
16274754|NCT00828867|Drug|1500 mg GSK investigational drug|
16274755|NCT00828867|Drug|800mg fed GSK investigational drug|
16274756|NCT00828867|Drug|3000mg GSK investigational drug|
16274757|NCT00828867|Drug|4000mg GSK investigational drug|
16274758|NCT00828854|Drug|entinostat (SNDX-275)|5 mg PO every week
16274759|NCT00828841|Drug|Cetuximab|Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
16274760|NCT00828841|Drug|Paclitaxel|Paclitaxel 200 mg/m2 Day 1 every 21 days
16274761|NCT00828841|Drug|Carboplatin|Carboplatin AUC 6 Day 1 every 21 days
16274762|NCT00828841|Drug|Gemcitabine|Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
16274763|NCT00828841|Drug|Cisplatin|Cisplatin 75 mg/m2 Day I every 21 days
16274764|NCT00828828|Biological|Influenza Vaccine|One 0.5 ml dose of influenza vaccine injected intramuscular.
16274765|NCT00828815|Drug|TMC125|
16274936|NCT00827515|Drug|PH797804|Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
16275411|NCT00823849|Other|Control Group|Routine treatment
16274766|NCT00828802|Drug|Lenalidomide, Decitabine|Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
16274767|NCT00828789|Drug|Efavirenz; Tenofovir disoproxil fumarate; Telaprevir|
16274768|NCT00828776|Biological|Heparin sodic - Cristália|5000UI/mL
16274769|NCT00828776|Biological|heparin - Liquemine (Roche)|5000UI/mL
16274770|NCT00828763|Drug|[14c}-GSK1349572|HIV-Integrase inhibitor labelled with a carbon 14 marker
16274771|NCT00828750|Drug|Eltrombopag oral tablets|Eltrombopag oral tablets once daily
16274772|NCT00828737|Drug|Gadobutrol (Gadovist, BAY86-4875)|Gadovist in approved indications at approved dosages
16274773|NCT00828724|Drug|Lorcaserin 10mg|
16274774|NCT00828711|Drug|MVI 100|Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16274775|NCT00828711|Drug|MVI 150|Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16274776|NCT00828711|Drug|MVI 200|Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16274777|NCT00828698|Other|No intervention|
16274778|NCT00828685|Procedure|CRPP|Closed reduction, percutaneous pinning
16274779|NCT00828685|Procedure|ORIF|Open reduction, internal fixation
16274780|NCT00828672|Drug|Oxaliplatin|Administered on days 15,22,29,36 en 43; 50 mg/m2
16274781|NCT00828672|Drug|Bevacizumab|Administered on days 1,15,29 and 43 ; 5mg/kg
16274782|NCT00828672|Drug|Capecitabine|825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
16274783|NCT00828672|Radiation|radiotherapy|Total dose 45Gy
16274784|NCT00828659|Drug|Placebo|
16274785|NCT00828659|Drug|Active Comparator #1|
16274786|NCT00828659|Drug|Active Comparator #2|
16274787|NCT00828659|Drug|Active Comparator #3|
16274788|NCT00828659|Drug|Lorcaserin Dose #1|
16274789|NCT00828659|Drug|Lorcaserin Dose #2|
16274790|NCT00828659|Drug|Lorcaserin Dose #3|
16274791|NCT00828646|Drug|BMS-708163|Capsules, Oral, 50 mg, once daily, 14 days
16274792|NCT00828646|Drug|BMS-708163|Capsules, Oral, 100 mg/day, once daily, 14 days
16274793|NCT00828646|Drug|BMS-708163|Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
16274794|NCT00828646|Drug|Placebo|Capsules, Oral, once daily, 14 days
16274795|NCT00828620|Other|Imaging study|PET-CT
16274796|NCT00828594|Drug|RAD001|
16274797|NCT00828594|Drug|RAD001, sorafenib|
16274798|NCT00828581|Drug|lorcaserin|
16274799|NCT00828568|Drug|Imiquimod 5% manufactured by Taro|Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
16274800|NCT00828568|Drug|Aldara - Imiquimod 5%|Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
16274801|NCT00828568|Drug|Imiquimod Vehicle manufactured by Taro|Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks
16274802|NCT00828555|Other|Vaccination Program|Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis
16274803|NCT00828542|Drug|etonogestrel implant|Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum)
16274804|NCT00828542|Drug|depot medroxyprogesterone acetate|150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery
16274805|NCT00828529|Drug|TMC207|
16274806|NCT00828516|Other|Acupuncture and moxibustion|Acupuncture is a form of traditional east Asian medicine that uses needles inserted superficially under the skin to stimulate sites on the body known as acupuncture points. Traditional practice encompasses moxibustion, the application of heat (usually from the smouldering herb artemisia vulgaris or mugwort) to stimulate the points by warming them.
16274807|NCT00828503|Drug|Certican (everolimus) + valganciclovir|"Oral MED 1: Certican® initial dose: 1,5-3 mg day target trough level: 3-8 ng/mL (first levels will be performed after 3 days and then adjusted until - according to the judgement of the clinical investigator - a stable degree of immunosuppression is reached; thereafter Certican® trough levels will be performed at the scheduled appointments)
~MED 2: Valganciclovir (or ganciclovir) will be administered in addition to Certican (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily)"
16274808|NCT00828503|Drug|Valganciclovir|Valganciclovir (or ganciclovir) will be administered alone (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily)
16274809|NCT00828490|Behavioral|provider feedback|The provider-level intervention includes a targeted review of trigger-flagged beneficiaries' drug utilization history and an information packet sent to providers which includes patient-specific pharmacy and medical claims history, patient specific recommendations, and provider comparative profiling.
16274810|NCT00828490|Behavioral|patient intervention|The patient intervention arm includes the provider-level intervention mentioned above in addition to Medication Therapy Management Services (MTMS), a program that provides patients one-on-one therapy counseling administered by community pharmacists who have completed an MTMS certificate program.
16274811|NCT00828490|Behavioral|Process-level|The process-level intervention includes the provider-level intervention plus in-clinic evidence-based quality improvement workshops with opportunity for CME credit
16274812|NCT00828477|Drug|Xibrom|Xibrom: two times a day for seven days in the first eye.
16274813|NCT00828477|Drug|Nevanac|Nevanac: three times a day for seven days in the second eye.
16274814|NCT00828464|Drug|clobetasol propionate|Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.
16275976|NCT00820105|Drug|ADX10059|Oral administration
16274815|NCT00828451|Biological|[5,5,5-2H3]leucine (stable isotope labeled leucine)|intravenous infusion of labeled leucine dissolved in 5% glucose water: priming dose of 18 micromoles (1.8 ml)/kg over 5 minutes, then 18 micromoles (1.8 ml)/hr for 6 hours; one infusion total
16274816|NCT00828438|Drug|Lorcaserin 10mg|
16274817|NCT00828412|Device|EpiCeram Skin Barrier Emulsion|topical cream, twice daily, 6 weeks
16274818|NCT00828412|Drug|Desonide Cream 0.05%|topical cream, twice daily, 6 weeks
16274819|NCT00828399|Dietary Supplement|Glutamine|Oral glutamine 30g/day
16274820|NCT00828399|Dietary Supplement|Whole protein|Oral whole protein 30 g/day
16274821|NCT00828386|Procedure|Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy|Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy
16274822|NCT00828373|Drug|Placebo|Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the Placebo group this will be physiologic saline. The infusion will be stopped after complete recovery from the neuromuscular block.
16274823|NCT00828373|Drug|Lidocaine|Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the lidocaine Arm this regimen corresponds to 1.5 mg kg-1 lidocaine bolus injection and 2 mg kg-1 h-1 lidocaine continuous infusion. The infusion will be stopped after complete recovery from the neuromuscular block.
16274824|NCT00828347|Drug|1.0 μg/day Alfacalcidol|We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
16274825|NCT00828347|Drug|0.25 μg/day Alfacalcidol|We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
16274826|NCT00828334|Device|Transcatheter PDA Coil|The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.
16274827|NCT00828321|Drug|Ramipril 10 mg capsule|1 x 10 mg
16274828|NCT00828321|Drug|Altace® 10 mg capsule|1 x 10 mg
16274829|NCT00828308|Drug|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
16274830|NCT00828308|Procedure|Prostatectomy|
16274831|NCT00828295|Drug|palonosetron|palonosetron IV 1 mcg/kg
16274832|NCT00828295|Drug|palonosetron|palonosetron 3mcg/kg IV
16274833|NCT00828282|Drug|Simvastatin|Treatment will be administered on an outpatient basis. Subjects will be given 7.5 mg/kg twice daily of Simvastatin for 7 days on a 21-day cycle with a goal of 6 cycles.
16274834|NCT00828269|Procedure|Comparator: Fine needle aspiration biopsy|"Visit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver.
~Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit"
16274835|NCT00828256|Procedure|arthroscopy of shoulder|arthroscopic repair of chronic rotator cuff tears
16274836|NCT00828243|Drug|Nutrient|We administer stable isotopically labeled precursors of surfactant phospholipids ([1-13C1] acetate) and of surfactant protein-B ([5,5,5-2H3] leucine) to infants with neonatal respiratory distress syndrome. Using mass spectrometry, we measure incorporation of stable isotopically labeled precursors in tracheal aspirates and compare surfactant phospholipid and surfactant protein-B turnover.
16274837|NCT00828230|Drug|budesonide|One application of 2mg budesonide once daily for 8 weeks
16274838|NCT00828230|Drug|Placebo foam|One application of placebo foam once daily for 8 weeks
16274839|NCT00828217|Other|adapted physical activity|one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital
16274840|NCT00828204|Device|single-use autoinjector with a prefilled liquid Avonex syringe|
16274841|NCT00828204|Device|Avonex prefilled syringe via manual IM injection|
16274842|NCT00828204|Drug|BG9418 (interferon beta-1a)|
16274843|NCT00828191|Drug|Progesterone|25 mg, once a day, SC
16274844|NCT00828191|Drug|Progesterone|100 mg, twice a day, vaginally
16274845|NCT00828178|Drug|Omega-3|Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks
16274846|NCT00828178|Device|flow-mediated dilation of the brachial artery|flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks
16274847|NCT00828178|Other|corn starch|3 capsules qd for 12weeks
16274848|NCT00828165|Drug|ARRY-300, MEK inhibitor; oral|single dose, escalating
16274849|NCT00828165|Drug|Placebo|matching placebo
16274850|NCT00828152|Behavioral|Internet-delivered CBT.|12 weeks. Therapist contact through e-mail.
16274851|NCT00828152|Behavioral|On line discussion group|Placebo. On line discussion group.
16274852|NCT00828139|Biological|ziv-aflibercept|Given IV
16274853|NCT00828139|Drug|topotecan hydrochloride|Given IV
16274854|NCT00828126|Procedure|PET-CT Scan|Positron emission tomography-computed tomography (PET-CT) scan performed within 30 days of contrast-enhanced CT.
16274855|NCT00828113|Drug|varenicline|Extension of 1 mg twice daily treatment to 52 weeks
16274856|NCT00828113|Drug|varenicline|Double-blind switch to placebo after 12 weeks of open-label therapy
16274857|NCT00828113|Behavioral|Individual smoking cessation counseling|Brief (<10 minutes) smoking cessation counseling delivered at clinic visits
16274858|NCT00828100|Device|fluID Rapid Influenza Test|The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC) setting.
16274937|NCT00827515|Drug|PH797804|Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state
16274938|NCT00827489|Drug|HTC-867|
16274939|NCT00827489|Other|Placebo|
16274859|NCT00828100|Device|BinaxNOW® Influenza A & B|The BinaxNOW Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.
16274860|NCT00828087|Drug|Everolimus Eluting Coronary Stent System|Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
16274861|NCT00828087|Device|cobalt chromium balloon expandable stent ( non drug eluting stent Arm)|cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
16274862|NCT00828074|Drug|sorafenib tosylate|Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 3 = 200 mg by mouth in the am and 400 mg by mouth in the pm on days 1-28 of a 28 day cycle. Dose level 4 = 400 mg by mouth two times a day on days 1-28 of a 28 day cycle.
16274863|NCT00828074|Drug|vinorelbine ditartrate|Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 3 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 4 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle.
16274864|NCT00828061|Drug|Placebo|Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
16274865|NCT00828061|Drug|prednisone|Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
16274866|NCT00828061|Drug|prednisone|Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
16274867|NCT00828035|Procedure|laparoscopic surgery|comparison of two different laparoscopic surgeries : robot versus human
16274868|NCT00828022|Biological|attenuated measles vaccine|4-week apart, two vaccines starting 4 weeks after last chemotherapy
16274869|NCT00828009|Biological|bevacizumab|IV
16274870|NCT00828009|Biological|Tecemotide|
16274871|NCT00828009|Drug|carboplatin|IV
16274872|NCT00828009|Drug|cyclophosphamide|IV
16274873|NCT00828009|Drug|paclitaxel|IV
16274874|NCT00828009|Radiation|radiotherapy|radiotherapy is given 5 days a week for 6½ weeks during concomitant chemoradiotherapy
16274875|NCT00827996|Drug|adalimumab|Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12
16274876|NCT00827983|Drug|Progesterone|25 mg, s.c., once à day
16274877|NCT00827983|Drug|Progesterone|90 mg, vaginally, once à day
16274878|NCT00827970|Behavioral|Screening for urogenital Chlamydia trachomatis|Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
16274879|NCT00827957|Device|Internal Cooling|The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.
16274880|NCT00827957|Device|External Cooling|The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.
16274881|NCT00827944|Device|Parietex Progrip|"Surgical technique:
~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
16274882|NCT00827944|Device|Low weight polypropylene mesh|"Surgical technique:
~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
16274883|NCT00827931|Drug|Tranexamic acid + Standard of Care|Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
16274884|NCT00827931|Procedure|Standard of Care|Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
16274885|NCT00827918|Drug|MK-8998|MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.
16274886|NCT00827918|Drug|Comparator: Olanzapine|Olanzapine 5 mg tablets twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 5 mg tablets in the morning and 10 mg tablets in the evening. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.
16274887|NCT00827918|Drug|Comparator: Placebo|Placebo tablets matching olanzapine tablets and MK-8998 capsules
16274888|NCT00827905|Device|RSpot Non-Contact Respiratory Rate Spot Check|The Kai Sensors RSpot 100 provides a measurement of respiratory rate at a single point in time. It uses a low-power radar to detect respiratory effort, and analyzes the respiratory effort signal to provide a respiratory rate.
16274889|NCT00827892|Drug|Pioglitazone|Escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI
16274890|NCT00827892|Drug|Placebo Control|Lactose Capsule administered by mouth daily for the duration of the study as determined by MRI
16274891|NCT00827879|Behavioral|Strength at Home Couples Group|A multiple site randomized trial will compare 10 sessions of PF-RET to 10 sessions of a supportive group therapy. PF-RET focuses on 1) deployment stress and traumatic experiences impacting intimate relationships; 2) communication between intimate partners; 3) conflict and anger management; and 4) closeness and intimacy.
16274892|NCT00827879|Behavioral|Supportive Group Therapy|A general support group designed to enhance support for healthy relationship building.
16274940|NCT00827476|Procedure|ovarian transplantation|ovarian xenotransplantation or in vitro culture
16274941|NCT00827463|Biological|dosage of the NFS and iron|a blood test will be made.
16274893|NCT00827866|Other|Counselor-Initiated Tobacco Quit Line|The proposed active intervention will be a the Counselor-Initiated QL which includes provision of 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention.
16274894|NCT00827866|Other|Self-Paced Tobacco Quit Line|The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition.
16274895|NCT00827853|Procedure|Conventional angioplasty balloon|Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
16274896|NCT00827853|Procedure|cryoplasty balloon|Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon
16274897|NCT00827840|Drug|Paliperidone ER|3mg to 12mg of Paliperidone ER once a day
16274898|NCT00827840|Drug|Risperidone|1 to 6 mg of risperidone once or twice a day
16274899|NCT00827827|Other|Exercise- Strength Training|3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.
16274900|NCT00827827|Other|Exercise- Stretching Control|3x per week upper and lower body stretching mixed with active and passive range of motion exercises
16274901|NCT00827814|Drug|Dutasteride|Dutasteride 0.5 mg od.
16274902|NCT00827801|Behavioral|MDASI-HF Questionnaire|M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 & 8.
16274903|NCT00827788|Drug|Iodixanol|Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
16274904|NCT00827788|Drug|Iopromide|Low-osmolar contrast medium (Iopromide) will be administered during PCI
16274905|NCT00827775|Drug|Carvedilol|Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
16274906|NCT00827762|Drug|Kuvan|20/mg/kg/day taken once daily or as otherwise prescribed by physician as standard care.
16274907|NCT00827749|Device|respiratory plethysmography by inductance|contribution of respiratory plethysmography by inductance and informatic tool
16274908|NCT00827736|Procedure|Botox|injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
16274909|NCT00827736|Drug|ISDN ointment|application of ISDN 1% ointment 6 times a day
16274910|NCT00827736|Drug|Placebo|"Injection of placebo into internal anal sphincter (ISDN ointment arm)
~Applied to the anoderm six times a day (Botox injection arm)"
16274911|NCT00827710|Behavioral|point of care patient report cards|gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals
16274912|NCT00827710|Behavioral|Provider performance report card|Gives provider feedback on performance on their diabetes panel of patients and includes patient level data
16274913|NCT00827697|Other|Gen-Probe APTIMA Combo2 (AC2)|Laboratory Test
16274914|NCT00827684|Drug|Irinotecan|
16274915|NCT00827684|Drug|Temsirolimus|
16274916|NCT00827671|Drug|cetuximab|cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment
16274917|NCT00827671|Radiation|radiotherapy to oesophageal tumour|45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk
16274918|NCT00827658|Procedure|Volar Wrist Block|"Injection medial to Flexor Carpi Ulnaris Tendon at volar proximal wrist crease
~Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)"
16274919|NCT00827658|Procedure|Hypothenar Palm block|"Injection at Hook of the Hamate on Palmar surface
~Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)"
16274920|NCT00827632|Drug|Low dose formulation|"Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
~Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet."
16274921|NCT00827632|Drug|High dose formulation|"Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
~Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet."
16274922|NCT00827619|Device|Zilver® Flex™ Vascular Stent|Stenting of the Above-the-Knee Femoropopliteal Artery
16274923|NCT00827606|Drug|atorvastatin|Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)
16274924|NCT00827593|Behavioral|Standard behavioral weight loss treatment|Participants will receive 12 months of university-based behavioral weight loss treatment
16274925|NCT00827593|Behavioral|Weight Watchers|Participants will receive 12 months of Weight Watchers
16274926|NCT00827593|Behavioral|Combined Treatment|Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers
16274927|NCT00827580|Drug|Eniluracil|
16274928|NCT00827567|Drug|RAD 001|RAD 001-10 mg by mouth once everyday
16274929|NCT00827554|Drug|LMWH|Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks
16274930|NCT00827554|Procedure|TACE|transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。
16274931|NCT00827541|Drug|Tigecycline|Tigecycline 50 or 100 mg intravenously. Therapy conducted according to the package leaflet of Tygacil and to international treatment guidelines. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.
16274932|NCT00827528|Procedure|Traditional correction of anterior vaginal wall prolapse|"Traditional repair.
~Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery."
16274933|NCT00827528|Procedure|Biologic Graft (SIS)|"Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
~Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery."
16274934|NCT00827515|Drug|PH797804|Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
16274935|NCT00827515|Drug|PH797804|Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
16274942|NCT00827450|Dietary Supplement|Ctl|Control, isocaloric diet; no coffee
16274943|NCT00827450|Dietary Supplement|High fructose diet; no coffee|Hypercaloric, high fructose diet; no coffee
16274944|NCT00827450|Dietary Supplement|fully torrefied, caffeine-free coffee|Hypercaloric, high fructose diet + coffee
16274945|NCT00827450|Dietary Supplement|partially torrefied, caffeine-free coffee|Hypercaloric, high fructose diet + coffee
16274946|NCT00827450|Dietary Supplement|Partially torrefied, caffeinated coffee|Hypercaloric, high fructose diet + coffee
16274947|NCT00827437|Other|Parent Interview|To include the PI, Nursing Research Specialist,Clinical Research Associate or Clinical Nurse Specialist
16274948|NCT00827424|Behavioral|Lifestyle counseling by applying a modified PACE protocol|Lifestyle counseling by applying a modified PACE protocol to obese Arab women
16274949|NCT00827411|Drug|Aspirin and clopidogrel / Prasugrel|modification of aspirin and clopidogrel/Prasugrel maintenance doses based on a biological assay
16274950|NCT00827411|Device|VerifyNow|point of care assay VerifyNow (ACCUMETRICS San Diego USA)
16274951|NCT00827411|Drug|Aspirin and clopidogrel / Prasugrel|aspirin and clopidogrel/ Prasugrel maintenance doses (according to international guidelines)
16274952|NCT00827411|Drug|Aspirin and clopidogrel / Prasugrel|maintenance dose of clopidogrel / Prasugrel and aspirin
16274953|NCT00827411|Drug|Aspirin|Interruption of clopidogrel / Prasugrel after one year of follow-up
16274954|NCT00827398|Biological|MSC (hPPL)|Treatment with MSCs (hPPL) is indicated as soon as steroid refractory acute GVHD is diagnosed
16274955|NCT00827372|Drug|Pazopanib|Pazopanib will be administered at a starting dose of 800 mg orally once each day.
16274956|NCT00827359|Drug|Everolimus|Tablet form taken orally once a day
16274957|NCT00827346|Drug|Clopidogrel|600 mg now
16274958|NCT00827346|Drug|Clopidogrel|600 mg now and 600 mg in 3 hours
16274959|NCT00827346|Drug|Clopidogrel|900 mg now
16274960|NCT00827346|Drug|Clopidogrel|600 mg now and 300 mg in 3 hours
16274961|NCT00827333|Other|educational intervention|Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
16274962|NCT00827333|Other|questionnaire administration|Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
16274963|NCT00827333|Procedure|end-of-life treatment/management|Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
16274964|NCT00827333|Procedure|psychosocial assessment and care|Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
16274965|NCT00827333|Procedure|quality-of-life assessment|Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
16274966|NCT00827320|Drug|Levetiracetam|1000 mg tablet
16274967|NCT00827307|Drug|tamoxifen|In the monotherapy arm, patients receive once-daily oral dose of tamoxifen 20 mg.
16274968|NCT00827307|Drug|Goserelin|In the combination arm, patients receive ZOLADEX 3.6 mg by subcutaneous injection every 4 weeks along with once-daily oral dose of tamoxifen 20 mg
16274969|NCT00827294|Behavioral|Mirror Therapy|The study is an uncontrolled pilot. Subjects receive instruction in performing mirror therapy at home, either in person or by viewing a DVD. Subjects will be asked to practice mirror therapy 20 minutes daily. Subjects will complete questionnaires for phantom pain, function, depressive symptoms, anxiety, catastrophizing, and sleep quality at baseline and post treatment at 1 month, 2 months, 3 months, and 6 months. Subjects will keep a diary of their practice and study staff will check in with subjects weekly for the first month, and monthly thereafter.
16274970|NCT00827281|Drug|D-cycloserine|Single dosage prior to sessions 3, 4 & 5
16274971|NCT00827281|Drug|Placebo|Single dosage prior to sessions 3, 4 & 5
16274972|NCT00827268|Behavioral|One-on-one treatment of reading difficulties|Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.
16274973|NCT00827255|Drug|Cyclosporine Ophthalmic Emulsion 0.05%|One drop two times a day approximately 12 hours apart
16274974|NCT00827242|Drug|Placebo|Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.
16274975|NCT00827242|Drug|tadalafil|Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.
16274976|NCT00827229|Device|Labor Monitor|
16274977|NCT00827216|Drug|Placebo|For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing ≥100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min.
16274978|NCT00827216|Drug|Erythromycin|For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing ≥100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min. The regimen corresponds to 3 mg/kg of erythromycin.
16274979|NCT00827203|Drug|Elesclomol Sodium|Chemotherapy agent
16274980|NCT00827190|Drug|ILS-920|
16275014|NCT00826891|Drug|Cisplatin Combined With Topotecan|"Patients must have specific minimum neutrophil and platelet counts before administration of Hycamtin. The dose of Hycamtin is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course).
~Dosage adjustments for subsequent courses of Hycamtin in combination with cisplatin are specific for each drug.
~Dose levels for cisplatin Initial dose 0 = 50 mg/m2 Dose reduction level -1 = 37.5 mg/m2 Dose reduction level -2 = 25 mg/m2
~Dose levels for topotecan Initial dose 0 = 0.75 mg/m2 Dose reduction level -1 = 0.60 mg/m2 Dose reduction level -2 = 0.45 mg/m2"
16274981|NCT00827177|Drug|Treatment with ARQ 197 in combination with sorafenib|"Patients will be treated with ARQ 197 and sorafenib at Dose Level 1 (ARQ 197 360 mg twice daily (bid) and sorafenib 200 mg bid). Patients with HCC will start treatment with ARQ 197 at 240 mg bid and sorafenib 200 mg bid. Enrollment of subsequent patient cohort will depend on the safety and tolerability of the combination treatment in the initial cohort.
~If < 33% patients treated at Dose Level 1 experience dose-limiting toxicity(ies) (DLT) by the end of first treatment cycle (4 weeks), then next cohort of 6 patients will be enrolled and treated at Dose Level 2 (ARQ 197 360 mg bid and sorafenib 400 mg bid). If ≥ 33% patients treated at Dose Level 1 experience DLT(s) by the end of first treatment cycle, the next cohort of 6 patients will be enrolled and treated at Dose Level 0 (ARQ 197 240 mg bid and sorafenib 200 mg bid)."
16274982|NCT00827164|Behavioral|Nutrition Counseling|Patients will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.
16274983|NCT00827164|Behavioral|Resistance Training|Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients will receive guidance in a safe and appropriate exercise regimen based on specific medical history and preference. An exercise specialist will telephone weekly for consultation and support once per week for the final 6 weeks.
16274985|NCT00827138|Drug|DCC-2036|150 mg BID tablets, continuous dosing of 28 day cycles
16274986|NCT00827125|Device|LaborPro device|monitoring labor progression by using a new device The LaborPro system (Trig Medical Inc) allows determination of fetal head station and position using ultrasound and position tracking system.
16274987|NCT00827112|Drug|maraviroc|maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
16274988|NCT00827112|Drug|maraviroc|emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
16274989|NCT00827099|Biological|anti-thymocyte globulin|anti-thymocyte globulin
16274990|NCT00827099|Drug|fludarabine phosphate|fludarabine phosphate
16274991|NCT00827099|Drug|Melphalan|melphalan
16274992|NCT00827099|Drug|mycophenolate mofetil|mycophenolate mofetil
16274993|NCT00827099|Drug|tacrolimus|tacrolimus
16274994|NCT00827099|Procedure|umbilical cord blood transplantation|umbilical cord blood transplantation
16274995|NCT00827073|Drug|tetracaine 0.5%|betadine 5%
16274996|NCT00827073|Drug|Lidocaine 2% Jelly|Betadine 5%
16274997|NCT00827047|Procedure|Total hemihepatic vascular exclusion|A long vascular clamp is inserted along the midline of the anterior surface of the vena cava,proceed cranially up to the space between the right and the middle hepatic vein trunks. Two tapes are seized with the clamp passing between the anterior surface of the IVC and the liver parenchyma.One tape is use to pass around the hepatic parenchyma for occlusion of the bleeding from the remnant liver;the other is used to loop the right (or left )hepatic vein trunk and short hepatic vein,as well as inferior right hepatic vein,if present. Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection.Thus total hemihepatic vascular exclusion is achieved.
16274998|NCT00827047|Procedure|Hemihepatic vascular Clamping|Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection. Selective clamping can be achieved after carefully dissecting the right from the left hilar branches or after inserting a clamp between the right and left hilar branches without prior hilar dissection and looping the right or left portal structures with a tape.
16274999|NCT00827047|Procedure|Pringle's Maneuver|Hepatic pedicle clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.
16275000|NCT00827034|Drug|Warfarin|A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.
16275001|NCT00827034|Drug|Dimebon|B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets
16275002|NCT00827034|Drug|Warfarin|B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets
16275003|NCT00827021|Drug|Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.|4000 IU/week I.V. Until the end of the trial
16275004|NCT00827021|Drug|Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.|18000 IU/week I.V. Until the end of the trial
16275005|NCT00827008|Drug|Neramexane mesylate|Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
16275006|NCT00826995|Other|Patient Educational Materials|In the experimental arm, the intervention is the video-based patient educational material on melanoma. In the active comparison arm (control arm), the comparison intervention is written patient educational material on melanoma.
16275007|NCT00826969|Drug|Ciclesonide|320µg Ciclesonide versus Placebo
16275008|NCT00826969|Drug|Placebo|Placebo
16275009|NCT00826956|Procedure|one lung ventilation|measure the pulmonary blood flow in nondependent lung during 30min one lung ventilation
16275010|NCT00826943|Drug|Cetirizine|Cetirizine 10 mg tab daily x 7 days
16275011|NCT00826943|Drug|Levocetirizine|5 mg tab daily x 7 days
16275012|NCT00826943|Drug|Placebo|Placebo tablet daily x 7 days
16275013|NCT00826930|Drug|Trans Sodium Crocetinate (TSC)|Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
16275015|NCT00826878|Drug|Tivozanib (AV-951)|"Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) once daily continuously beginning on Day 1 for 4 weeks. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicity.
~Minimum of 8 weeks (2 consecutive dosing cycles), if tolerated."
16275016|NCT00826865|Drug|Levetiracetam|750 mg tablet
16275017|NCT00826852|Drug|docetaxel and carboplatin|weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5
16275018|NCT00826839|Drug|Oral contraceptive pill and microdose lupron|Desogestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg, one tablet by mouth daily for 14 days Leuprolide acetate 40 µg by subcutaneous injection twice a day during ovarian stimulation (approximately 14 days)
16275019|NCT00826839|Drug|E2 patch/antagonist|"Estradiol transdermal system 0.1 mg/day (25 cm2 patch. Patch changed every other day x 3. Final patch left on for about 7 days. Total duration of therapy approximately 14 days.
~Gonadotropin-releasing hormone antagonist 0.25 mg subcutaneously every other day for 3 total doses."
16275020|NCT00826826|Procedure|Catheter ablation|(Pulmonary vein isolation)
16275021|NCT00826826|Drug|Amiodarone|From the day of the catheter ablation procedure and 8 weeks forward.
16275022|NCT00826826|Drug|Placebo|From the day of the catheter ablation procedure and 8 weeks forward.
16275023|NCT00826813|Device|Esophageal stent placement|The esophageal stent combined a self-expandable covered esophageal stent and 125I radioactive seeds. Sheathes were attached to the outer surface of the stent, containing 125I radioactive seeds of CIAE 6711. The seeds were loaded into the sheathes on the stent immediately before implantation of the stent. The numbers and dose of the radioactive stent seeds was determined by the treatment plan system based on the size of the individual tumor. To cover the entire lesion of the tumor by the sheaths containing 125I seeds, at least 2 cm exceeding the tumor margins was required. The distance between the two sheaths was 15mm. In the control group, conventional covered esophageal stents were used which provided by the same company as those attached with 125I seeds.
16275024|NCT00826800|Drug|FOLFOX and bevacizumab|The patient will receive six treatments, two weeks apart. On each treatment day you will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments you will also get Bevacizumab (Avastin). These drugs are given through a Mediport. They will be given in an outpatient chemotherapy unit. Each tx will take about 4 hours. A pump for the 5-FU is worn around your waist. This drug is given over 2 days. Part II: Colon Cancer Surgery is standard practice, and is not a research procedure.Part III: Post-operative Re-Evaluation and Recovery The doctor will decide on the type of chemotherapy based on how the patient responded to the first chemotherapy. The plan will be for the patient to get 6 more doses of FOLFOX, without any further bevacizumab, unless your doctor finds a reason to do otherwise.
16275025|NCT00826787|Drug|Levetiracetam|750 mg tablet
16275026|NCT00826774|Behavioral|Usual Care|Participants in this group will receive usual medical care, provided by their own primary care providers (PCPs). PCPs also will provide participants recommendations for weight management at quarterly-scheduled visits.
16275027|NCT00826774|Behavioral|Brief Lifestyle Counseling|These participants, like those in the Usual Care group, will receive the same PCP visits, plus monthly brief counseling sessions with an auxiliary health care provider (e.g., a medical assistant), on-site or by phone.
16275028|NCT00826774|Behavioral|Enhanced Brief Lifestyle Counseling|These participants will receive the same intervention as those in the Brief Lifestyle Counseling condition, including quarterly PCP visits and monthly sessions with a medical assistant who will instruct them in lifestyle modification. These individuals also will select, in consultation with their PCP, the use of either meal replacements or weight loss medication, to facilitate the induction and maintenance of weight loss
16275029|NCT00826761|Dietary Supplement|probiotic|One capsule per meal test (high dose or low dose)
16275030|NCT00826761|Dietary Supplement|placebo|1 capsuel every morning
16275031|NCT00826748|Drug|Beclomethasone|The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
16275032|NCT00826735|Behavioral|Guided imagery|A relaxation focused guided imagery intervention was used through the remainder of pregnancy plus a physiologic guided imagery intervention was used during the third stage of labor.
16275033|NCT00826722|Drug|Levetiracetam|1000 mg tablet
16275034|NCT00826709|Device|fluID Rapid Influenza Test|The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).
16275035|NCT00826683|Biological|Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures|
16275036|NCT00826670|Drug|Decolonization|"Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days
~plus In the presence of urinary tract colonization choice of one of the following agents (according to susceptibility profile, creatinine clearance and individual contraindications) Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days"
16275037|NCT00826670|Drug|Placebo (Decolonization)|Placebo
16275038|NCT00826657|Dietary Supplement|Vitamin B12|500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
16275039|NCT00826657|Dietary Supplement|placebo|placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
16275040|NCT00826644|Drug|Belotecan|Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
16275041|NCT00826644|Drug|Etoposide|Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
16275042|NCT00826644|Drug|Cisplatin|Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
16275043|NCT00826631|Procedure|Fast food arm|Doubling of regular caloric intake based on fast food, no exercise allowed
16275044|NCT00826618|Drug|ranibizumab|This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
16275099|NCT00826202|Drug|D-serine|60 mg/kg/day
16275045|NCT00826592|Other|Patient Educational Materials|In the experimental arm, the intervention is the video-based patient educational material on atopic dermatitis. In the active comparison arm (control arm), the comparison intervention is written patient educational material on atopic dermatitis.
16275046|NCT00826579|Procedure|Sentinel lymph node procedure|After careful mobilization of the affected colon segment, isosulfan blue 1% is injected in vivo into the subserosa circumferentially around the tumor. Lymph nodes in the mesentery staining blue within the first minutes are marked as SLN. The procedure is followed by a resection of the affected colon segment with standard lymphadenectomy.
16275047|NCT00826579|Procedure|Bone marrow aspiration|Prior to surgery, bone marrow is aspirated from both iliac crests. Bone marrow aspirates are analyzed for the presence of occult metastatic colon cancer cells.
16275048|NCT00826566|Dietary Supplement|Caffeine|2 times 250 mg caffeine per day
16275049|NCT00826566|Dietary Supplement|placebo|2 times 250 mg per day
16275050|NCT00826553|Drug|Dexmedetomidine|Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.
16275051|NCT00826553|Drug|GABA agonist|Patients sedated with GABA agonists (e.g. propofol, benzodiazepines) during mechanical ventilation will be enrolled. Patients randomized to the GABA agonist arm will continue the sedative that is active at enrollment. The specific drug as well as dosage, frequency, and duration will be determined and titrated by the managing clinical team.
16275052|NCT00826540|Drug|sorafenib tosylate|Given orally
16275053|NCT00826540|Biological|bevacizumab|Given IV
16275054|NCT00826527|Drug|Solifenacin PO|Tab 5 mg Daily for 12 Weeks
16275055|NCT00826514|Drug|Tanezumab|Intravenous, 20 mg, single dose.
16275056|NCT00826514|Drug|Placebo|Intravenous placebo, single dose
16275057|NCT00826501|Procedure|Endoscopic cyst-gastrostomy|After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
16275058|NCT00826501|Procedure|Surgical cyst-gastrostomy|After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
16275059|NCT00826488|Device|Digital Breast Tomosynthesis|Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.
16275060|NCT00826475|Behavioral|Mindfulness Based Stress Reduction MBSR|Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
16275061|NCT00826475|Behavioral|Psychoeducation|Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
16275062|NCT00826462|Drug|triamcinolone|Injection with triamcinolone 10 mg at start and at 3 weeks
16275063|NCT00826462|Drug|Placebo|Injection with sodium chloride at start and at 3 weeks
16275064|NCT00826462|Drug|Lidocaine|10 mg of lidocaine at start and at 3 weeks
16275065|NCT00826462|Other|Physiotherapy|12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
16275066|NCT00826462|Drug|Naproxen|Naproxen 500 mg bid for 14 days
16275067|NCT00826449|Drug|Dasatinib|Starting dose of 70 mg by mouth daily for 21 day cycle.
16275068|NCT00826449|Drug|Erlotinib|150 mg by mouth daily every 21 day cycle.
16275069|NCT00826410|Device|Redon drain|subcutaneous suction drain after laparotomy for two days
16275070|NCT00826397|Procedure|Acupuncture|Each acupuncture session will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.
16275071|NCT00826397|Procedure|Sham Acupuncture|The sham acupuncture session will consist of superficial needling at nonspecific body points, administered twice weekly for six weeks, and will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.
16275072|NCT00826384|Procedure|balloon catheter|transcatheter arterial chemoembolization therapy with balloon catheter
16275073|NCT00826371|Drug|ranibizumab 0.5 mg|
16275074|NCT00826358|Drug|ABT-143|Once, please see Arm Description for more details.
16275075|NCT00826358|Drug|ABT-335|Once, see Arm Description for more detail
16275076|NCT00826358|Drug|rosuvastatin|once, see Arm Description for more detail
16275077|NCT00826345|Other|Acupuncture / Moxibustion|"Acupuncture/Moxibustion points will be administered per point prescription.
~- Active"
16275078|NCT00826345|Other|Acupuncture/Moxibustion|Sham/Placebo Acupuncture/Moxibustion - Not active
16275079|NCT00826332|Procedure|transabdominal ultrasound|transabdominal ultrasound
16275080|NCT00826332|Procedure|transvaginal ultrasound|transvaginal ultrasound
16275081|NCT00826306|Other|Patient Educational Materials|In the experimental arm, the intervention is the video-based patient educational material on sunscreen. In the active comparison arm (control arm), the comparison intervention is written patient educational material on sunscreen.
16275082|NCT00826293|Procedure|Stabilization belt|Patients receive true stabilization.
16275083|NCT00826293|Procedure|Stabilization belt|Patients receive sham stabilization.
16275084|NCT00826280|Drug|regadenoson|IV
16275085|NCT00826280|Drug|overencapsulated caffeine|oral
16275086|NCT00826280|Radiation|technetium|IV
16275087|NCT00826280|Drug|placebo|oral
16275088|NCT00826267|Drug|lapatinib|lapatinib tablets 1500 mg daily
16275089|NCT00826267|Drug|BIBW 2992|BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
16275090|NCT00826267|Drug|trastuzumab|trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
16275091|NCT00826254|Drug|Vitamin K|180 micrograms vitamin K daily
16275092|NCT00826254|Drug|Vitamin K|"2 capsules daily 180 micrograms vitamin K daily or placebo
~1 year"
16275093|NCT00826241|Drug|Temozolomide|Starting dose 125 mg/m^2 daily by mouth on days 1-7 & 15-21 of a 28 day cycle.
16275094|NCT00826241|Drug|Lapatinib|Starting dose 1250 mg daily by mouth.
16275095|NCT00826228|Drug|teriparatide|teriparatide 20ug daily sc for 6 months
16275096|NCT00826228|Other|weight-bearing|device assisted walking
16275097|NCT00826215|Device|electroacupuncture|Nine sections of 45 minutes electroacupuncture treatment in three weeks
16275098|NCT00826215|Device|Sham laser acupuncture|Sham laser acupuncture
16275101|NCT00826176|Drug|Sugammadex|After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.
16275102|NCT00826163|Drug|Budesonide|Inhaled budesonide 400 mcg twice a day for 2 weeks
16275103|NCT00826150|Biological|BC-819|"Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
~Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
~Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course."
16275104|NCT00826137|Dietary Supplement|Inulin and fructo-oligosaccharides.|Supplement during antibiotic treatment+14 days.
16275105|NCT00826137|Dietary Supplement|Placebo|Placebo is base powder of product with no oligosaccharides.
16275106|NCT00826124|Procedure|Epidural steroid injection|Injection based solely on history and physical exam
16275107|NCT00826124|Procedure|Epidural steroid injection|Two epidural steroid injections two weeks apart based on history, physical exam and MRI
16275108|NCT00826124|Procedure|Magnetic Resonance Imaging (MRI)|Imaging of lumbar spine
16275109|NCT00826111|Drug|Eszopiclone|Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone.
16275110|NCT00826111|Drug|Placebo|Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.
16275111|NCT00826098|Biological|Platelet Rich Plasma|Addition of PRP to total knee replacement procedure
16275112|NCT00826085|Drug|ThermoDox in combination with Microwave Hyperthermia (heat)|"ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion.
~Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system.
~All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals."
16275113|NCT00826059|Device|Active Sphenopalatine Ganglion (SPG) Stimulation|SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
16275114|NCT00826059|Device|Sham Sphenopalatine Ganglion (SPG) Stimulation|Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
16275115|NCT00826046|Drug|Prochymal®|Patients will be treated with Prochymal twice per week at a dose of 2 x 106 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
16275116|NCT00826020|Drug|Omegaven™|10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
16275117|NCT00825994|Drug|Omega-3 Fatty Acids|2 g omega-3 fatty acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), PO [by mouth], qd [every day]
16275118|NCT00825981|Other|screening coagulation abnormalities|if specific coagulation abnormalities are observed which increase patient's risk of bleeding, appropriate treatment will start
16275119|NCT00825955|Drug|Brivanib|Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
16275120|NCT00825955|Other|Placebo|Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
16275121|NCT00825955|Procedure|Best Supportive Care|Trans-Arterial Chemo-Embolization (TACE) Therapy
16275122|NCT00825942|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 180 days
16275123|NCT00825916|Drug|AZX100 Drug Product|Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16275124|NCT00825916|Drug|AZX100 Drug Product|Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16275125|NCT00825916|Drug|Placebo|Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
16275126|NCT00825903|Behavioral|Exercise|Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.
16275127|NCT00825864|Drug|diclofenac drops|one drop 4 times a day for 3 months
16275128|NCT00825864|Drug|dexamethasone sodium phosphate 0.1% eye drops|for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week
16275129|NCT00825851|Drug|Transdermal nicotine patch|15mg/16h + 10mg/16h to be used 24h
16275130|NCT00825851|Drug|Placebo patch|
16275131|NCT00825851|Behavioral|Smoking cessation|
16275132|NCT00825851|Behavioral|Continuous smoking|subjects smoke 20 cigarettes per day
16275133|NCT00825838|Dietary Supplement|Chronic consumption of chili pepper extract|6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
16275134|NCT00825838|Dietary Supplement|Chronic consumption of matching placebo|0mg chili pepper extract (matching placebo) per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
16275135|NCT00825825|Drug|Escitalopram|One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.
16275136|NCT00825825|Drug|Citalopram|One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.
16275137|NCT00825825|Drug|Placebo|Two weeks of placebo taken orally.
16275138|NCT00825812|Drug|Sugammadex|After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.
16275139|NCT00825812|Drug|neostigmine|After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
16275140|NCT00825786|Drug|Ropivacaine|ropivacaine (15 ml).
16275141|NCT00825786|Drug|Mepivacaine|One syringe will contain mepivacaine (15 ml)
16275142|NCT00825773|Device|Percutaneous Transluminal Coronary Angioplasty|Patients will be randomly assigned (2:1) to one of two treatment arms (the Excel DES or the Cypher DES). Randomization will be stratified by study site and number of vessels intended to be treated by the site investigator. Randomization will be accomplished through use of envelope randomization at the sites using the pre-assigned envelope randomization system. The study patient is considered enrolled upon randomization.
16275143|NCT00825760|Drug|Topical PPA904 gel and light|
16275144|NCT00825760|Drug|Topical placebo gel plus light|
16275145|NCT00825747|Device|SeeLens AF intra-ocular lens|the SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery.
16275146|NCT00825734|Drug|Sorafenib|Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg)
16275147|NCT00825734|Drug|Ixabepilone|Dose Level 1 - Ixabepilone IV every 21 days (40mg/m^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m^2)
16275148|NCT00825721|Drug|LiquiTears|4 drops applied daily for 360 days
16275149|NCT00825721|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 360 days
16275150|NCT00825721|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 360 days
16275151|NCT00825721|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 360 days
16275152|NCT00825708|Device|rTMS|42 2 sec trains of 20HZ rTMS in 100% MT
16275153|NCT00825708|Device|shamTMS|sham TMS session
16275154|NCT00825695|Dietary Supplement|cocoa|two servings of cocoa daily for one month
16275155|NCT00825682|Other|Reflexology treatment.|Reflexology treatments (45 min. each) will be initiated at the beginning of radiation therapy, once a week, for 10 weeks.The treatment includes manual pressure on specific points of foot soles and massage of the calf area, adapted individually to each patient.
16275156|NCT00825669|Drug|TACE|TACE: The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery. The chemotherapeutic drugs include 5-Fu 1500 mg, epirubicin 30 mg, cisplatin 30 mg.
16275157|NCT00825669|Procedure|Laser ablation|Laser ablation is given to the PVTT.
16275158|NCT00825656|Drug|Sinol or Sinol-M nasal spray|"One spray in each nostril up to a maximum of 12 times / day on an as needed basis"
16275159|NCT00825643|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation
16275160|NCT00825630|Drug|Lansoprazole (Lanton)|Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection
16275161|NCT00825630|Drug|Omeprezole (Losec)|Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection
16275162|NCT00825630|Drug|Pantoprazole(Controloc)|Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection
16275163|NCT00825630|Drug|Esomeprazole (Nexium)|Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection
16275164|NCT00825617|Drug|Hormone replacement therapy|Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for days 13-22 and 1 mg 17β-estradiol/day for days 23-28 (Trisekvens, Novo Nordisk A/S, Bagsværd, Denmark)
16275165|NCT00825604|Procedure|Percutaneous coronary angioplasty (PCI)|optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):
16275166|NCT00825591|Dietary Supplement|Melatonin|Oral administration before bed. We will test two doses (0.5 or 3.0 mg/m2. 6 week duration.)
16275167|NCT00825591|Dietary Supplement|Placebo Comparator|Oral administration before bed. 6 week duration.
16275168|NCT00825578|Device|Intra-bronchial valve (Spiration IBV)|Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
16275169|NCT00825565|Drug|Alwextin cream|Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.
16275170|NCT00825552|Drug|Risperidone|0,5-4 mg/day for 8 weeks (twice a day)
16275171|NCT00825539|Drug|AQW051|
16275172|NCT00825539|Drug|Placebo|
16275173|NCT00825526|Behavioral|Mindfulness Based Stress Reduction (MBSR) Therapy|The objectives of MBSR therapy are to 1) understand their personal response to stress and 2) develop techniques to change the way these patients respond and cope with stress
16275174|NCT00825513|Device|Akreos Toric IOL|Lens implant following cataract surgery
16275175|NCT00825513|Device|Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)|Lens implant following cataract surgery
16275176|NCT00825500|Drug|Inhaled Placebo|Inhaled Staccato placebo (0 mg)
16275177|NCT00825500|Drug|Inhaled Loxapine 1.25 mg|Inhaled Staccato Loxapine 1.25 mg, single dose
16275178|NCT00825500|Drug|Inhaled Loxapine 2.5 mg|Inhaled Staccato Loxapine 1.25 mg, single dose
16275179|NCT00825487|Drug|ARQ 621|Treatment will be initiated at a dose level of 10 mg/m^2 IV infusion for an hour once weekly in 4-week (28 day) consecutive and continuous cycles. ARQ 621 should be infused IV over two hours at doses 200 mg/m^2 and higher (cohort 8 and above).
16275180|NCT00825474|Other|operation;TACE plus PEI|Under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.
16275181|NCT00825448|Procedure|Hospitalization for a week|Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
16275182|NCT00825435|Procedure|Coronary CT Angiogram|Coronary CT Angiogram
16275183|NCT00825422|Drug|Ropivacaine / Placebo|Wound infiltration with local anesthesics/placebo through a parietal paravertebral catheter
16275184|NCT00825396|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 150 days
16275185|NCT00825383|Other|High Fiber and Moderate Fiber Diets|Dietary
16275186|NCT00825370|Drug|Hydromorphone|1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
16275187|NCT00825370|Drug|IV opioid|Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
16275188|NCT00825344|Drug|Etanercept|50 mg subcutaenous preoperatively
16275189|NCT00825344|Drug|Saline|Given subcutaneously preoperatively
16275190|NCT00825318|Procedure|Ultrafiltration|Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.
16275191|NCT00825305|Biological|Abbreviated Zagreb 2-1-1 schedule|Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
16275192|NCT00825305|Biological|Standard Essen 1-1-1-1-1 schedule|Subjects received the standard Essen regimen.
16275193|NCT00825292|Procedure|Polp removal and identification|Identify polyp during colonoscopy then remove polyp
16275194|NCT00825292|Procedure|colon polyp removal|identify and remove polyp
16275195|NCT00825292|Procedure|ETMI colonoscope (ETMI scope is a FDA approved device)|ETMI colonoscope used to identify colon polyps as compared to HD white light colonoscope identifying colon polyps.
16275196|NCT00825279|Device|Bare Metal Stent|Stainless steel stent
16275197|NCT00825279|Device|Drug Eluting Stent|stent coated with the biodegradable polymer matrix hemoparin and paclitaxel
16275198|NCT00825266|Drug|bosentan|Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.
16275199|NCT00825266|Drug|Pioglitazone|Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.
16275200|NCT00825253|Drug|biphasic insulin aspart 30|
16275201|NCT00825253|Drug|biphasic human insulin 30|
16275202|NCT00825240|Behavioral|One-time Questionnaire + Recorded Qualitative Interview|One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.
16275203|NCT00825227|Drug|Armodafinil 150 mg/day|"150 mg/day armodafinil
~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
16275204|NCT00825227|Drug|Placebo,|"placebo
~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
16275205|NCT00825214|Device|Zapperclick|Device deliveres small piezoelectrical discharge to bite site (forearm)
16275206|NCT00825214|Device|Inactivated zapperclick device|placebo
16275207|NCT00825201|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IP
16275208|NCT00825201|Other|liquid chromatography|Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
16275209|NCT00825201|Other|mass spectrometry|Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
16275210|NCT00825201|Other|pharmacological study|Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
16275211|NCT00825201|Other|laboratory biomarker analysis|Correlative studies
16275212|NCT00825188|Drug|eplerenone, amlodipine|Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
16275213|NCT00825188|Drug|eplerenone|Eplerenone 25-50mg daily x 8 weeks
16275214|NCT00825188|Drug|eplerenone|eplerenone 25- 50 mg daily for 8 weeks
16275215|NCT00825188|Drug|amlodipine|amlodipine 5-10mg daily for 8 weeks
16275216|NCT00825175|Behavioral|Treadmill Training|Parents hold their infants on an infant treadmill for 8 minutes a day, 5 days a week. The treadmill speed is set at 0.2 m/s.
16275217|NCT00825175|Device|Supramalleolar Orthoses|In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
16275218|NCT00825162|Biological|CSL Limited Influenza Virus Vaccine|Single or two-vaccination regimen (0.25mL)
16275219|NCT00825162|Biological|CSL Limited Influenza Virus Vaccine|Single or two-vaccination regimen (0.5mL)
16275220|NCT00825162|Biological|CSL Limited Influenza Virus Vaccine|Single vaccination regimen (0.5mL)
16275221|NCT00825149|Drug|Bendamustine|Bendamustine will be administered as per schedule specified in the respective arm.
16275222|NCT00825149|Drug|Cyclophosphamide|Cyclophosphamide will be administered as per schedule specified in the respective arm.
16275223|NCT00825149|Drug|Doxorubicin|Doxorubicin will be administered as per schedule specified in the respective arm.
16275224|NCT00825149|Drug|Fludarabine|Fludarabine will be administered as per schedule specified in the respective arm.
16275225|NCT00825149|Drug|Obinutuzumab|Obinutuzumab will be administered as per schedule specified in the respective arm.
16275226|NCT00825149|Drug|Prednisone|Prednisone will be administered as per schedule specified in the respective arm.
16275227|NCT00825149|Drug|Vincristine|Vincristine will be administered as per schedule specified in the respective arm.
16275228|NCT00825136|Behavioral|relaxation|Participants were asked to log in the system to keep the muscle relaxation program every day and complete some self-rating scales on browser every week.
16275229|NCT00825136|Behavioral|biofeedback (finger temperature biofeedback)|Participants were asked to log in the system to keep the muscle relaxation program plus finger temperature biofeedback every day and complete some self-rating scales on browser every week.
16275230|NCT00825123|Drug|Ivabradine|Ivabradine 10 mg once
16275231|NCT00825123|Drug|Metoprolol|Metoprolol 50 mg once
16275232|NCT00825123|Drug|Placebo|Lactose powder
16275233|NCT00825097|Procedure|Selective tibial neurotomy|Selective tibial neurotomy is a neurosurgical intervention consisting in partially and selectively cutting the motor nerve branches destinated to the spastic muscles.
16275234|NCT00825097|Drug|Botulinum toxin injection|Botulinum toxin type A
16275235|NCT00825084|Drug|Dimebon|dose escalation of single oral doses of 5, 10 and 20 mg
16275236|NCT00825084|Drug|Dimebon|dose escalation of single oral doses of 5, 10 and 20 mg
16275237|NCT00825084|Drug|Dimebon|10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
16275238|NCT00825084|Drug|Dimebon|10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
16275239|NCT00825071|Drug|Dexamethasone|8 mg, Intravenous
16275240|NCT00825071|Drug|Ondansetron|4 mg, intravenously
16275241|NCT00825071|Drug|normal saline|2 ml, intravenously
16275242|NCT00825058|Drug|amibegron (SR58611A)|oral administration 2 X 350mg/day at 12 hours intervals
16275243|NCT00825058|Drug|placebo|oral administration 12 hours intervals
16275244|NCT00825058|Drug|paroxetine|oral 20 mg/day
16275245|NCT00825045|Drug|risperidone|Following the baseline clinical and cognitive assessments, risperidone will be initiated at 0.5-1.0 mg/day and subsequently increased by 0.25 - 1.0 mg on a weekly basis with the target of clinical stabilization (i.e. 20 or more % reduction in the total BPRS score) until a maximum dose of 4.0 mg/day is reached. To achieve this, a weekly assessment with BPRS will be performed. Physicians-of-record will be closely liaised with investigators. Dosage modification will be performed following this dosing schedule, however, this can be changed by treating physicians to meet clinical necessity. For example, in case psychotic symptoms are not controlled by this dosing schedule, facilitated dose increment will be allowed.
16275246|NCT00825032|Procedure|comprehensive PR|Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
16275247|NCT00825032|Procedure|UEET|Experimental program consisting of 15 additional daily sessions of unsupported UEET.
16275248|NCT00825019|Drug|amibegron (SR58611A)|oral administration of 2x 700 mg/day in 12h intervals
16275249|NCT00825019|Drug|placebo|oral administration in 12h intervals
16275250|NCT00825019|Drug|paroxetine|oral administration of 20 mg/day
16275251|NCT00825006|Device|Triple site pacing mode|"The experimental Triple site pacing mode includes pacing with Cardiac resynchronization therapy device using two leads; one in the right ventricle (RV) and one in the left ventricle (LV) but stimulates three sites: LV tip, RV tip and RV ring (instead of the usual two sites: LV tip and RV ring.
~Patients with evidence of improved LV dyssinchrony parameters during the triple pacing mode (anodal stimulation) will be programmed to anodal stimulation for 3 months."
16275252|NCT00824993|Drug|Ibandronate|Infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant.
16275253|NCT00824993|Drug|Vitamin Supplements|"Calcium 500 mg by mouth everyday for 12 months
~Vitamin D 400 units by mouth 2 times a day for 12 months"
16275254|NCT00824980|Drug|IP10.C8|IP10.C8 Gel 1%
16275255|NCT00824967|Other|Training and valuation of the treating personnel|Training and valuation of the treating personnel
16275256|NCT00824954|Procedure|ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)|ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
16275257|NCT00824928|Procedure|Cryoablation / Cryotherapy|Salvage Cryoablation of the prostate
16275258|NCT00824902|Procedure|Tissue Elastography Imaging|Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.
16275259|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275260|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275261|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275262|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275263|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275264|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275265|NCT00824889|Other|Biopsy and sample of blood|Biopsy and sample of blood
16275266|NCT00824863|Drug|ketoconazole 2% foam|topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.
16275267|NCT00824850|Biological|13-valent Pneumococcal Conjugate Vaccine|single injection, single dose, single site, 0.5 mL per dose.
16275268|NCT00824850|Biological|13-valent Pneumococcal Conjugate Vaccine|single injection, single dose, single site, 0.5 mL per dose.
16275269|NCT00824837|Other|Larger pore haemodialysis membrane|Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.
16275270|NCT00824837|Other|Standard haemodialysis membrane|Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.
16275271|NCT00824824|Drug|Dorzolamide 2%-timolol 0.5%|BID OU for 6 weeks
16275272|NCT00824824|Drug|Brimonidine 0.2%-0.5% timolol 0.5|BID OU for 6 weeks
16275273|NCT00824811|Drug|Cyclosporine Eye Drops (Restasis)|One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
16275274|NCT00824811|Drug|Lubricant Eye Drops (Refresh Endura™)|One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
16275275|NCT00824811|Drug|Fluorometholone Eye Drops (FML Forte®)|"Week 1: One drop four times a day to both eyes.
~Week 2: One drop three times a day to both eyes.
~Week 3: One drop twice a day to both eyes.
~Week 4: One drop once a day to both eyes.
~Wait at least 10 minutes after Restasis® or Refresh Endura™ instillation to instill FML Forte®."
16275276|NCT00824785|Drug|epirubicin, oxaliplatin, capecitabine (EOX)|epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21
16275277|NCT00824785|Drug|EOX + panitumumab|epirubicin 50mg/m(2) IV on day 1 oxaliplatin 100mg/m(2) IV on day 1 with hydration capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 panitumumab -9 mg/kg every 21 days
16275278|NCT00824759|Other|pure oxygen breathing versus air|one group will breath pure oxygen; the other will breath air
16275279|NCT00824746|Drug|Gefitinib retreatment|phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.
16275280|NCT00824733|Drug|Trastuzumab|IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.
16275281|NCT00824733|Drug|PF03512676|Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.
16275282|NCT00824733|Other|Correlative Studies|Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18.
16275283|NCT00824720|Drug|High Dose Device|inserted for 14 days
16275284|NCT00824720|Drug|Low Dose Device|inserted for 14 days
16275285|NCT00824720|Device|Placebo Device|inserted for 14 days
16275286|NCT00824707|Drug|Entecavir|Entecavir 0.5mg per day
16275287|NCT00824707|Drug|conventional therapy|conventional therapy including protecting the liver function, anti-tumor and so on
16275288|NCT00824694|Other|Targeted Self-Monitoring Of Blood Glucose (SMBG)|SMBG will alternate between 2 strategies: glucose profiling and target monitoring.
16275289|NCT00824694|Other|Provider Training|Focused on normalizing the most significant glucose abnormalities at any given time.
16275290|NCT00824694|Other|Patient Education|Focused on normalizing the most significant glucose abnormalities at any given time.
16275291|NCT00824681|Behavioral|Sound Of Family Together (S.O.F.T.) Music Program|Audio compact disk containing songs, music, special messages, poems from children of adults with major burns
16275292|NCT00824681|Other|Non-Therapy Related Activities (NTRA)|NTRA includes non-directed activities e.g. reading books/magazines, watching TV/movie in family lounge off the BICU, playing with toys, listening to music CDs/radio.
16275293|NCT00824668|Drug|biphasic insulin aspart 30|
16275294|NCT00824668|Drug|insulin glargine|
16275295|NCT00824668|Drug|insulin glulisine|
16275296|NCT00824655|Biological|13vPnC|13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
16275297|NCT00824655|Biological|13vPnC|13vPnC will be administered by intramuscular injection at approximately 12 months of age.
16275298|NCT00824642|Device|Transcutaneous electrical nerve stimulation (TENS)|Applied 45 minutes prior to exercise
16275299|NCT00824642|Device|placebo|placebo TENS applied prior to exercise
16275300|NCT00824629|Procedure|Afterloading embryo transfer procedure|Afterloading embryo transfer procedure
16275301|NCT00824629|Procedure|Direct embryo transfer procedure|Direct embryo transfer procedure
16275302|NCT00824616|Drug|MK-0941|MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
16275303|NCT00824616|Drug|Placebo|Placebo tablets, taken 3 times daily.
16275304|NCT00824616|Drug|Insulin|Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
16275305|NCT00824590|Drug|Dimebon|a single oral dose of 20 mg Dimebon
16275306|NCT00824590|Drug|Dimebon|a single oral dose of 20 mg Dimebon
16275307|NCT00824564|Drug|Tranexamic Acid plus standard of care|Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
16275308|NCT00824564|Procedure|Standard of care|Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
16275309|NCT00824551|Procedure|Hyperbaric Oxygen Therapy|2 sessions of HBOT ( HDMC 14)
16275310|NCT00824551|Other|Standard care|Patient will undergo standard care
16275311|NCT00824538|Drug|sunitinib malate|
16275312|NCT00824538|Other|flow cytometry|
16275313|NCT00824538|Other|immunohistochemistry staining method|
16275314|NCT00824538|Other|laboratory biomarker analysis|
16275315|NCT00824512|Drug|EGb 761 120 mg|EGb 761® 120 mg bid, orally for 12 to 14 weeks
16275316|NCT00824512|Drug|Placebo|Placebo 1 tablet BID, orally for 12 to 14 weeks
16275317|NCT00824499|Other|Complex regional intervention|"Components of the complex intervention:
~Introduction of a program coordinator
~Introduction of a self-management education program
~Bottom up development of a interdisciplinary care protocol
~Support program for the intiation of insulin therapy in primary care
~Regional audit"
16275318|NCT00824486|Behavioral|Injury prevention education (TIPP)|using TIPP materials
16275319|NCT00824486|Behavioral|Injury prevention education (safe home)|using safe home model
16275320|NCT00824473|Drug|Placebo|Placebo
16275321|NCT00824473|Drug|0.15% azelastine hydrochloride|0.15% azelastine hydrochloride 822 mcg
16275322|NCT00824460|Drug|1.25 g PA21 (250 mg iron)|Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
16275323|NCT00824460|Drug|5.0 g PA21 (1,000 mg iron)|Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
16275324|NCT00824460|Drug|7.5 g PA21 (1,500 mg iron)|Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
16275325|NCT00824460|Drug|10.0 g PA21 (2,000 mg iron)|Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
16275326|NCT00824460|Drug|12.5 g PA21 (2,500 mg iron)|Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
16275327|NCT00824460|Drug|Sevelamer hydrochloride|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
16275328|NCT00824447|Drug|Oralgen|allergen solution sublingually
16275329|NCT00824447|Other|placebo|placebo control
16275330|NCT00824434|Device|PROMUS Element™|Drug eluting coronary stent system
16275331|NCT00824421|Drug|UK-453, 061|UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
16275332|NCT00824421|Drug|UK-453, 061|UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
16275333|NCT00824421|Drug|EFV +TVA|Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
16275334|NCT00824408|Drug|pemetrexed|500 mg/m^2 i.v. on day 1 of 21 day cycle
16275335|NCT00824408|Drug|pemetrexed|500 mg/m^2 i.v. on day 1 of 21 day cycle
16275336|NCT00824408|Drug|BI 6727|BI 6727 i.v. on day 1 of a 21 day cycle
16275337|NCT00824382|Drug|BI 1744 CL 2 Âµg|2 puffs of 1 Âµg/actuation delivered by the RespimatÂ® inhaler
16275338|NCT00824382|Drug|BI 1744 CL 5 Âµg|2 puffs of 2.5 Âµg/actuation delivered by the RespimatÂ® inhaler
16275339|NCT00824382|Drug|BI 1744 CL 10 Âµg|2 puffs of 5 Âµg/actuation delivered by RespimatÂ®
16275340|NCT00824382|Drug|Placebo|2 puffs delivered by the RespimatÂ® inhaler
16275341|NCT00824369|Drug|No drug will be administered|No drug will be administered.
16275342|NCT00824356|Drug|GSK1004723 (200mg)|Intranasal antihistamine.
16275343|NCT00824356|Other|Placebo|Equivalent to GSK1004723 in presentation etc.
16275344|NCT00824356|Drug|GSK1004723 (1000mg)|Intranasal antihistamine.
16275345|NCT00824343|Drug|P276-00|For patients to be recruited in amended protocol, P276-00 will be administered to all subjects at a dose of 144 mg/m2/day as i.v infusion in 200 ml of 5% dextrose over 30 minutes from day 1 to day 5 and from day 8 to day 12 in each 21 day cycle. Subjects will receive treatment till progression of disease or till unacceptable toxicity. All subjects will be followed up for survival status till one year of initiation of protocol treatment.
16275346|NCT00824330|Behavioral|Control Phase; Exercise Phase|After the completion of the control phase and at the start of the titration phase of the study, participants will be given pedometers and log books, then contacted on a regular basis to help insure compliance with the goal of walking 10,000 steps per day.
16275347|NCT00824317|Drug|methylphenidate|(15 mg daily), medium (25 mg daily) and high (40 mg daily)
16275348|NCT00824317|Drug|Placebo|
16275349|NCT00824291|Drug|desvenlafaxine succinate sustained release|50 mg/day oral tablet for 12 weeks
16275350|NCT00824291|Genetic|Genotyping|CYP2D6 genotyping at randomization
16275351|NCT00824265|Drug|OFC Infusion|Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
16275352|NCT00824265|Drug|FC infusion|Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
16275353|NCT00824252|Behavioral|Questionnaires & Study Visit|Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
16275354|NCT00824239|Procedure|Intermittent sedation|Patients under intermittent sedation stay without any continuous sedation since intubation and/or admission but receive analgesics as needed and sedatives only when agitated (SAS of 5 or more).
16275355|NCT00824239|Procedure|Daily interruption of sedation|Patients under daily interruption of sedation stay on continuous sedation with midazolam and fentanyl and are submitted to a daily interruption of sedation to a neurological evaluation until they reach a SAS of 4 or more, then continuous sedation is re-started in the half previous dosage.
16275356|NCT00824226|Dietary Supplement|magnesium|magnesium 350 mg tablets once a day for 3 weeks
16275357|NCT00824200|Behavioral|Behavioral|Multicomponent Behavioral and Exercise Therapy (M-BET) - pelvic floor muscle exercises, urge suppression strategies, fluid strategies, sleep hygiene & non-pharmacological management of peripheral edema.
16275358|NCT00824200|Drug|tamsulosin (alpha-adrenergic antagonist medication)|0.4 mg given daily
16275359|NCT00824200|Drug|placebo|tamsulosin placebo
16275360|NCT00824200|Behavioral|placebo|placebo behavioral intervention
16275361|NCT00824187|Drug|EE20/DRSP(YAZ, BAY86-5300)|20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
16275362|NCT00824187|Drug|Placebo|Inert tablet
16275363|NCT00824174|Behavioral|Questionnaire|1 questionnaire, about 15-20 minutes.
16275364|NCT00824161|Drug|TAS-109|"14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.
~Number of cycles: until unacceptable toxicity or disease progression requires discontinuation."
16275365|NCT00824148|Device|Guardian REAL-Time Continuous Glucose Monitoring System|One group will use the glucose monitoring system for 1 month
16275366|NCT00824148|Other|Conventional self-monitoring of plasma glucose|Finger prick blood glucose measurements
16275367|NCT00824135|Drug|Clofarabine|"One dose intravenously every 24 hrs for five days total.
~Dose level 1 Clofarabine 40 mg/m2/day intravenous Dose level 2 Clofarabine 45 mg/m2/day intravenous Dose Level 3 Clofarabine 50 mg/m2/day intravenous"
16275368|NCT00824135|Procedure|Stem Cell Transplantation, Hematopoietic|Haploidentical Hematopoietic Stem Cell Transplantation (two infusions, one on day 0 and the other on day +1)
16275369|NCT00824135|Other|OKT3|"Start at 0.0125 mg/kg intravenous once a day, taper dose down incrementally and discontinue after 17 days total
~Muromonab-CD3"
16275370|NCT00824135|Drug|Thiotepa|5 mg/kg/day intravenous every 12 hours (2 doses total)
16275371|NCT00824135|Drug|Melphalan|60mg/m2 intravenous every 12 hours for 2 doses total.
16275372|NCT00824135|Drug|Mycophenolate mofetil|"Mycophenolate mofetil 600 mg/m2 intravenous two times a day
~(continue for approximately 2 months or as clinically indicated)"
16275373|NCT00824135|Drug|Rituximab|375 mg/m2 intravenous for 1 dose total
16275374|NCT00824135|Other|G-CSF|G-CSF 5 mcg/kg/day subcutaneous or intravenous until ANC greater than 2.000/mm3 for 2 consecutive days and then as clinically indicated.
16275375|NCT00824109|Device|Second Generation Anti-Microbial bifurcated vascular graft (InterGard)|treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
16275376|NCT00824096|Procedure|Bronchoscopy|The patients in our ICU intubated for > 24h and met weaning criteria, will be examined by bronchoscopy. Five ㏄ blood will be collected for checking CRP and cytokines before performing bronchoscopy. The proposed grading of post-extubation vocal cord finding were shown (Figure 1). The patients will be classified to two groups (Figure 2). The first group is these patients without swelling or swelling area ≦50% who will be extubated after bronchoscopic examination. These patients will be followed for 48 hours to monitor the incidence of PES. The second group is those patients who develop laryngeal edema with swelling area ≧50% or swelling in the whole vocal cord. Bosmin 2 ml local injection and Solu-medrol 40 mg I.V. Q6h for 1~4 days will be given. Bronchoscopy will be done if CLV ≧24% or after treatments for 3~4 days even with CLV <24%. The above treatments will be applied again if stridor develops. Extubation will be performed if no presence of laryngeal edema.
16275377|NCT00824070|Drug|Besifloxacin hydrochloride|Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
16275378|NCT00824070|Drug|moxifloxacin hydrochloride|Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
16275379|NCT00824070|Drug|gatifloxacin|Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
16275380|NCT00824057|Drug|AZD6280|oral
16275381|NCT00824057|Drug|Midazolam|oral
16275382|NCT00824057|Drug|Caffeine|oral
16275383|NCT00824044|Behavioral|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
16275384|NCT00824044|Drug|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
16275385|NCT00824005|Biological|Adult stem cells|Single procedure of intramyocardial electromechanical-guided injection of approximately 100 million bone marrow mononucleated cells (BM-MNCs), administered in 15 different injection sites
16275386|NCT00824005|Biological|Placebo|Single procedure of intramyocardial electromechanical-guided needle insertions and injection of 5% human serum albumin and saline in 15 different injection sites
16275387|NCT00823992|Drug|placebo|sc once weekly
16275388|NCT00823992|Drug|taspoglutide|10mg sc once weekly for 4 weeks, then 20mg sc once weekly
16275389|NCT00823979|Drug|UK-453,061 Dose 1|UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.
16275390|NCT00823979|Drug|UK-453,061 Dose 2|UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.
16275391|NCT00823979|Drug|Etravirine|Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.
16275392|NCT00823966|Drug|Rescriptor|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs."
16275393|NCT00823953|Drug|Momordica charantia|escalating doses of Momordica charantia administered in the form of capsules for the trial phase of three week.Dose level 1: capsules containing a total of 500 mg of freeze dried powder of Momordica charantia. Dose level 1: capsules containing a total of 1000 mg of freeze dried powder of Momordica charantia. Dose level 3: capsules containing a total of 1500mg of freeze dried powder of Momordica charantia.
16275394|NCT00823953|Other|starch powder|The placebo arm will be administered capsules containing a total of 500 mg of starch powder, at dose level 1; 1000 mg at dose level 2; 1500 mg at dose level 3.
16275395|NCT00823940|Drug|GSK1362885|5 - 100mg of GSK1362885 or placebo
16275396|NCT00823940|Drug|GSK1362885|100 - 600mg or placebo
16275397|NCT00823940|Drug|Glucagon|0.5mg IV bolus
16275398|NCT00823940|Drug|Glucagon + GSK1362885|0.5mg Glucagon IV bolus + selected dose of GSK1362885
16275399|NCT00823901|Drug|Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel|Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
16275400|NCT00823901|Drug|Placebo gel|Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
16275401|NCT00823888|Device|pneumatic brace|pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi
16275402|NCT00823875|Drug|Cilostazol group|Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.
16275403|NCT00823875|Drug|Probucol group|Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
16275404|NCT00823875|Drug|Cilostazol + Probucol group|"Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg（2 tablets）Bid.
~Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner"
16275405|NCT00823875|Drug|control group|routine treatment
16275406|NCT00823862|Drug|SD-101|Intramuscular (IM)
16275407|NCT00823862|Drug|ribavirin|oral, 2 times per day, for 2 months
16275408|NCT00823849|Drug|Cilostazol|From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
16275409|NCT00823849|Drug|Probucol|250 mg Bid, PO after breakfast and dinner.
16275410|NCT00823849|Drug|Cilostazol+Probucol|
16275412|NCT00823836|Drug|ropinirole PR/XR|"Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group.
~The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day).
~Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage.
~Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind.
~Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period."
16275413|NCT00823836|Drug|ropinirole IR|"Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group.
~The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day).
~Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage.
~Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind.
~Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period."
16275414|NCT00823823|Other|Bivalved cast|Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
16275415|NCT00823823|Other|Circumferential cast|Circumferential cast will be applied following closed reduction
16275416|NCT00823810|Other|PET/CT|18F-FDG PET/CT
16275417|NCT00823797|Drug|Bendamustine Hydrochloride|Given IV
16275418|NCT00823797|Other|Quality-of-Life Assessment|Ancillary studies
16275419|NCT00823784|Procedure|Transanal doppler hemorrhoidal ligation|THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy
16275420|NCT00823784|Procedure|stapled hemorrhoidopexy|Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture
16275421|NCT00823758|Behavioral|Focus Groups|6 to 8 participants per group.
16275422|NCT00823758|Behavioral|Personal Interviews|Conducted by phone and audiotaped.
16275423|NCT00823745|Drug|[14C]-PF-00868554|solution, single dose
16275424|NCT00823732|Other|educational intervention|Undergo individualized interdisciplinary palliative care intervention
16275425|NCT00823732|Other|medical chart review|Ancillary studies
16275426|NCT00823732|Other|questionnaire administration|Ancillary studies
16275427|NCT00823732|Procedure|end-of-life treatment/management|Undergo end-of-life treatment/management
16275428|NCT00823732|Procedure|psychosocial assessment and care|Undergo psychosocial assessment and care
16275429|NCT00823732|Procedure|quality-of-life assessment|Ancillary studies
16275430|NCT00823732|Procedure|management of therapy complications|Undergo management of therapy complications
16275431|NCT00823732|Procedure|assessment of therapy complications|Undergo assessment of therapy complications
16275432|NCT00823719|Drug|ofatumumab + ICE|"3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 milligrams (mg); cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg
~ICE regimen:
~ifosfamide + mesna - 5 grams (g)/meters squared (m^2)/24 hours (hrs) continuous on day 2 of dosing cycle; carboplatin - AUC 5 (800 mg maximum) on day 2 of dosing cycle; etoposide - 100 mg/m^2 on days 1, 2 and 3 of dosing cycle."
16275433|NCT00823719|Drug|ofatumumab + DHAP|"3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg.
~DHAP regimen:
~dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m^2/24 hrs continuous on day 1 of dosing cycle; cytarabine - 2 g/m^2 q12 hrs (2 doses) on day 2 of dosing cycle."
16275434|NCT00823693|Drug|Bimosiamose Cream|
16275435|NCT00823693|Drug|Placebo Cream|
16275436|NCT00823680|Drug|Placebo|po bid for 4 weeks
16275437|NCT00823680|Drug|RO5027838|200mg po qd for 4 weeks
16275438|NCT00823680|Drug|RO5027838|50mg po bid for 4 weeks
16275439|NCT00823680|Drug|RO5093151|400mg po bid for 4 weeks
16275440|NCT00823680|Drug|RO5093151|10mg po bid for 4 weeks
16275441|NCT00823667|Other|educational intervention|Palliative care intervention at weeks 3,4,5 and 6 post study enrollment
16275442|NCT00823667|Other|medical chart review|Occurs at 1 year post study enrollment
16275443|NCT00823667|Other|questionnaire administration|Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
16275444|NCT00823667|Procedure|end-of-life treatment/management|Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
16275445|NCT00823667|Procedure|psychosocial assessment and care|Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
16275446|NCT00823667|Procedure|quality-of-life assessment|Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
16275447|NCT00823654|Other|Blood draw and questionnaires|"At the start of the study: blood draw, questionnaire and menstrual calendar ↓ Start planned therapy (or observation/surveillance) for cancer treatment
~↓
~Tests in the middle of chemotherapy (if applicable):
~Blood draw and collection of monthly menstrual calendars ↓
~Tests when chemotherapy is over (if applicable):
~Blood draw and collection of monthly menstrual calendars
~↓
~Tests every 4 months for about 1 year:
~Blood draw, collection of monthly menstrual calendars, and questionnaire ↓
~Tests every 6 months for about 1 year:
~Blood draw, collection of monthly menstrual calendars, and questionnaire
~↓
~Yearly follow-up for about 2 years:
~Blood draw collection of monthly menstrual calendars, and questionnaire"
16275500|NCT00823303|Drug|Calcitriol|0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
16275501|NCT00823290|Drug|Sorafenib + LBH589|Sorafenib standard regimen + oral LBH589
16275502|NCT00823277|Other|Chronic care multidisciplinary intervention of childhood obesity|Overweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team). Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year.
16275448|NCT00823654|Other|Blood draw and questionnaires|"Study Schema for Unaffected High Risk Women with BRCA mutations Identify eligible premenopausal patients and obtain informed consent
~↓ Register patients at Memorial Sloan-Kettering Cancer Center
~↓ Baseline evaluation: Blood draw and baseline reproductive health and sexual questionnaires (Appendix A)/menstrual calendar (Appendix C)
~↓ Annual follow-up x 4 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health and sexual health questionnaires
~↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires
~↓ Optional annual follow-up years 2-5 Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires"
16275449|NCT00823641|Drug|Infliximab|Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study
16275450|NCT00823628|Drug|contrast agent (iopromide)|coronary angiography using the allocated contrast agent
16275451|NCT00823628|Drug|contrast agent (iodixanol)|coronary angiography using the allocated contrast agent
16275452|NCT00823615|Device|Lotrafilcon B multifocal contact lens|Silicone hydrogel, soft, multifocal contact lens for daily wear use
16275453|NCT00823615|Device|Senofilcon A multifocal contact lens|Silicone hydrogel, soft, multifocal contact lens for daily wear use
16275454|NCT00823602|Drug|ganirelix|These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).
16275455|NCT00823602|Drug|suprefact|GnRH agonist, standard protocol
16275456|NCT00823589|Other|Blood test and clinical test|Blood test and clinical test
16275457|NCT00823576|Drug|Ropivacaine|Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.
16275458|NCT00823563|Procedure|30 cc blood draw|
16275459|NCT00823563|Procedure|Intravascular ultrasound (IVUS)|
16275460|NCT00823563|Procedure|Coronary pressure/flow wire testing|
16275461|NCT00823563|Procedure|Coronary pressure/flow testing: Acetycholine challenge|
16275462|NCT00823563|Procedure|Procedure: Coronary pressure/flow testing: Nitroglycerin challenge|
16275463|NCT00823563|Procedure|Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge|
16275464|NCT00823550|Drug|Entecavir|entecavir 0.5 mg QD
16275465|NCT00823550|Drug|Lamivudine|lamivudine 100 mg QD
16275466|NCT00823537|Procedure|therapeutic electrical stimulation|
16275467|NCT00823524|Biological|donor natural killer cell infusion|give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
16275468|NCT00823498|Behavioral|Focus Group|6 Focus Groups asked how living in public housing effects physical activity and feelings about neighborhood.
16275469|NCT00823498|Behavioral|Interview|Interview with a member of study staff at housing development site.
16275470|NCT00823498|Other|Photovoice Project|Activity allowing expression of thoughts and feelings about neighborhood through neighborhood pictures taken by youth and parent(s).
16275471|NCT00823485|Procedure|fibrinolysis in situ|intraventricular injection of actilyse
16275472|NCT00823485|Procedure|drainage|drainage
16275473|NCT00823472|Drug|Mild stimulation|Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
16275474|NCT00823459|Drug|Everolimus|Given PO
16275475|NCT00823459|Other|Archival Tissue Analysis|Correlative studies
16275476|NCT00823446|Device|Revera Wound Care|Revalesio Part Number MDW0060
16275477|NCT00823446|Device|Normal Saline|Sodium Chloride for Irrigation
16275478|NCT00823433|Drug|oral penicillin V|2 grams of oral penicillin V given within 4 hours of delivery.
16275479|NCT00823420|Procedure|prematuration culture|"The aneuploidy rate and the developmental potential of embryos obtained from PDE3 inhibitor-treated oocytes (a prolonged IVM (PMC)) in comparison to conventional IVM will be analysed. It is intended to assess the nuclear and cytogenetic constitution of the obtained embryos."
16275480|NCT00823407|Drug|MDA|subjects will receive a single oral dose of MDA 98mg/70kg body weight
16275481|NCT00823407|Drug|Placebo|Subjects will receive a single oral dose of placebo
16275482|NCT00823394|Behavioral|Questionnaire|Completed privately via computer at Windsor Village Church, approximately 75 minutes. Repeated at Months 12 and 24.
16275483|NCT00823394|Other|Body Measurements|Waist, hip, height, and weight measured privately. Repeated at Months 12 and 24.
16275484|NCT00823394|Behavioral|Self-help Materials|Information on how to lower risk for developing cancer.
16275485|NCT00823381|Dietary Supplement|resveratrol|one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
16275486|NCT00823381|Other|placebo|one placebo pill taken once a day with breakfast
16275487|NCT00823381|Behavioral|Calorie Restriction|supervised calorie restriction diet: 30% reduction in caloric intake
16275488|NCT00823368|Drug|STX209|
16275489|NCT00823355|Drug|forodesine hydrochloride|Cohort 1: 100mg / body (1 x 100mg tablet once daily)
16275490|NCT00823355|Drug|forodesine hydrochloride|Cohort 2: 200mg / body (2 x 100mg tablets once daily)
16275491|NCT00823355|Drug|forodesine hydrochloride|Cohort 3: 300mg / body (3 x 100mg tablets once daily)
16275492|NCT00823355|Drug|forodesine hydrochloride|Cohort 4: 400mg / body (4 x 100mg tablets once daily)
16275493|NCT00823342|Drug|CLEVUDINE + TENOFOVIR PLACEBO|30 MG
16275494|NCT00823342|Drug|CLEVUDINE IN ASSOCIATION TENOFOVIR|TENOFOVIR 300 mg qd in association with CLEVUDINE 30 mg qd
16275495|NCT00823342|Drug|TENOFOVIR + CLEVUDINE PLACEBO|TENOFOVIR 300 mg qd + CLEVUDINE Placebo
16275496|NCT00823329|Device|cardiac stress testing with an exercise machine|Standardized graded cardiac stress testing with an exercise machine will be performed according to the protocol of the American Heart Association
16275497|NCT00823316|Biological|Human umbilical cord blood-derived mesenchymal stem cells|1x1,000,000 hMSC/kg, IV after unrelated HSCT
16275498|NCT00823316|Biological|Human umbilical cord blood-derived mesenchymal stem cells|5x1,000,000 hMSC/kg, IV after unrelated HSCT
16275499|NCT00823303|Drug|Paricalcitol|1 mcg daily, adjusted to achieve 40-60% PTH suppression
16275503|NCT00823264|Drug|Activated Charcoal|50 grams by mouth every 4 hours until serum phenytoin level is less than 25.
16275504|NCT00823251|Device|IlluminOss device|The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.
16275505|NCT00823238|Drug|ceftazidime and tobramycin|
16275506|NCT00823238|Drug|inhaled tobramycin|
16275507|NCT00823225|Procedure|standard therapy|wound debridement, moist wound dressing
16275508|NCT00823225|Drug|Urokinase|"Daily infusion up to 21 applications, dose dependent on fibrinogen level:
~> 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU"
16275509|NCT00823212|Device|PROMUS Coronary Stent System|PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
16275510|NCT00823212|Device|PROMUS Element Coronary Stent System|PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent).
16275511|NCT00823212|Drug|Aspirin|Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
16275512|NCT00823212|Drug|Thienopyridine|Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
16275513|NCT00823199|Drug|Allopurinal|300mg once daily by mouth for four weeks
16275514|NCT00823186|Drug|Phyxol(Paclitaxel)|"Paclitaxel is 5ß,20-Epoxyl-1,2α,4,7,β 10 β,13 α-hexahydroxytax-11-en-9-one 4,10
~-diacetae 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisocerine"
16275515|NCT00823173|Biological|ESBA105|ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals)
16275516|NCT00823160|Procedure|Sternotomy|Sternotomy performed after finding blood in the pericardial sac
16275517|NCT00823160|Procedure|Subxyphoid window|Subxyphoid window performed after the finding of blood in the pericardial sac
16275518|NCT00823147|Behavioral|Pain Catastrophizing Induction|Participants will undergo a psychologist-guided 10-minute induction of negative cognitive focus on the theoretical future worsening of one's pain condition.Biological stress response will be measured via heart rate, blood pressure and serum cortisol.
16275519|NCT00823134|Device|ApneaLink Plus|Device used to evaluate for the presence of obstructive, central or mixed apneas
16275520|NCT00823121|Procedure|freezing embryos by vitrification|vitrification by Cryotop method
16275521|NCT00823121|Procedure|fresh embryo transfers|fresh embryo transfers
16275522|NCT00823121|Drug|buserelin|Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
16275523|NCT00823121|Drug|recombinant FSH|gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
16275524|NCT00823121|Drug|human chorionic gonadotropin (pregnyl)|hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
16275525|NCT00823108|Drug|GIK|12 hour infusion of GIK solution
16275526|NCT00823095|Drug|Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
16275527|NCT00823082|Drug|Antithrombin III|Single dose of antithrombin III sufficient to achieve a preoperative level of 120%
16275528|NCT00823069|Device|Perlane and Perlane-L|This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
16275529|NCT00823056|Dietary Supplement|probiotics|placebo
16275530|NCT00823056|Dietary Supplement|probiotics|0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months
16275531|NCT00823043|Drug|timolol hemihydrate|timolol hemihydrate 0.5% solution
16275532|NCT00823043|Drug|timolol maleate|timolol maleate in sorbate
16275533|NCT00823030|Procedure|Urodynamic study|A small catheter will be inserted into the bladder and water will slowly be instilled through the catheter and into your bladder. A series of measurements will then be taken to assess your bladder's capacity to hold liquid, the average and maximum urine flow rates, as well as bladder filling and leak point pressure readings.
16275534|NCT00823030|Drug|Lidocaine|20 cc of alkalinized lidocaine will be injected after the first UDS
16275535|NCT00823030|Other|Normal Saline|20 cc of normal saline will be injected into the bladder after the first UDS
16275536|NCT00823017|Other|Patient-preferred music|Music of patients' preference
16275537|NCT00823017|Other|Relaxation Music|Relaxation music compiled from results of first three stages of study
16275538|NCT00823017|Other|Standard Care Environment|Control, no interventions
16275539|NCT00823004|Drug|letrozole|letrozole 5mg/day from day 3 to day 7 of menstrual cycle
16275540|NCT00823004|Drug|oral contraceptive (Marvelone)|oral contraceptive, first 21 days
16275541|NCT00823004|Drug|GnRH agonist (buserelin)|50 µg SC twice daily
16275542|NCT00823004|Drug|recombinant FSH or hMG|recombinant FSH or hMG 300-450 IU/day
16275543|NCT00823004|Drug|ganirelix acetate|GnRH antagonist (ganirelix acetate) when a leading follicle reaches a mean diameter of 14 mm, 0.25 mg per day (Antagon, Organon, West Orange, NJ)
16275544|NCT00822991|Device|CE-US (Sonazoid™)|screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
16275545|NCT00822991|Device|B-mode US|screening by conventional B-mode US every 3-5 months
16275546|NCT00822978|Drug|ACHN-490 Injection vs placebo|Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe.
16275547|NCT00822965|Other|Questionnaires|3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months.
16275548|NCT00822965|Other|Phone Interviews|2 follow-up phone interviews.
16275549|NCT00822965|Behavioral|Educational Packet|Video or DVD of device information, updates, recalls, on-line resources and benefits of routine follow-up for device(s).
16275550|NCT00822926|Drug|Botulinum Toxin Type A|Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
16275551|NCT00822926|Drug|Saline|Subcutaneous injection of saline into scar tissue
16275552|NCT00822913|Drug|Intravesical injection of Botulinum A toxin|One treatment, 200 U vials diluted in 20 ml normal saline
16275553|NCT00822900|Drug|Progesterone|Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.
16275554|NCT00822900|Drug|Placebo|"Placebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour loading dose of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours."
16275555|NCT00822887|Drug|Vandetanib|Dose level 1:100 mg qd Dose level 2:200 mg qd Dose level 3:300 mg qd
16275556|NCT00822887|Radiation|Fractionated Stereotactic Radiotherapy|All patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.
16275557|NCT00822874|Procedure|prematuration culture|"The aneuploidy rate and the developmental potential of embryos obtained from PDE3 inhibitor-treated oocytes (a prolonged IVM (PMC)) in comparison to conventional IVM will be analysed. It is intended to assess the nuclear and cytogenetic constitution of the obtained embryos."
16275558|NCT00822861|Drug|TPI ASM8|4 mg/mL, 1 mg BID for 4 days
16275559|NCT00822861|Drug|TPI ASM8|4 mg/mL, 2 mg BID for 4 days
16275560|NCT00822861|Drug|TPI ASM8|4 mg/mL, 4 mg BID for 4 days
16275561|NCT00822861|Drug|TPI ASM8|4 mg/mL, 8 mg OD for 4 days
16275562|NCT00822848|Drug|epirubicin hydrochloride|I.V., days 1-3 of each cycle. Epirubicin to be omitted during cycle 2 (concomitant chemoradiation)
16275563|NCT00822848|Drug|ifosfamide|Over 90 minutes I.V., days 1-3 of each cycle. Administered with hydration and Mesna.
16275564|NCT00822848|Drug|sorafenib tosylate|P.O. daily beginning 2 weeks before first chemotherapy cycle, held 1 week before and after surgery.
16275565|NCT00822848|Other|immunoenzyme technique|
16275566|NCT00822848|Other|immunohistochemistry staining method|
16275567|NCT00822848|Other|laboratory biomarker analysis|
16275568|NCT00822848|Procedure|adjuvant therapy|Preoperative administration has been the preference at our institution.
16275569|NCT00822848|Procedure|neoadjuvant therapy|
16275570|NCT00822848|Procedure|therapeutic conventional surgery|Surgery should be planned for 2-4 weeks after the initiation of chemotherapy for cycle 3.
16275571|NCT00822848|Radiation|hypofractionated radiation therapy|28 Gy (350 centigray (cGy) x 8 fractions in 10 days) beginning at the start of cycle 2. *Boost: postoperative boost of 12 Gy (200 cGy x 6 fractions) for patients with positive surgical margins only.
16275572|NCT00822835|Biological|ILV-095|
16275573|NCT00822835|Biological|Placebo|
16275574|NCT00822822|Behavioral|First Questionnaire|Complete questionnaire before completing health history
16275575|NCT00822822|Behavioral|Health History|Complete electronic health history
16275576|NCT00822822|Behavioral|Second Questionnaire|Complete questionnaire after completing electronic health history
16275577|NCT00822809|Drug|Catumaxomab|"Catumaxomab will be infused 4 times within 11 days as follows:
~10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10"
16275578|NCT00822809|Drug|Prednisolone|25 mg premedication
16275579|NCT00822796|Device|Thermogard™|Those who have a Thermogard™ central venous warming catheter placed prior to surgery
16275580|NCT00822796|Device|Standard central venous catheter|Those who have a standard central venous catheter placed prior to surgery
16275581|NCT00822783|Drug|Omalizumab|
16275582|NCT00822783|Drug|Placebo|
16275583|NCT00822770|Drug|Plerixafor|"Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
16275584|NCT00822770|Drug|Filgrastim|Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
16275585|NCT00822770|Drug|Fludarabine|Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
16275586|NCT00822770|Drug|Busulfan|Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
16275587|NCT00822770|Procedure|Allogeneic blood stem cell transplant|Stem Cell Infusion (Bone marrow or PBPC)
16275588|NCT00822770|Drug|ATG (Thymoglobulin)|Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
16275589|NCT00822757|Biological|Comparator: V710|Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
16275590|NCT00822757|Biological|Comparator: placebo|Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.
16275591|NCT00822744|Drug|SSR411298|"Form: capsule
~Route: oral administration with food"
16275592|NCT00822744|Drug|Escitalopram|"Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules)
~Route: oral administration with food"
16275593|NCT00822744|Drug|Placebo (for SSR411298)|"Form: capsule
~Route: oral administration with food"
16275594|NCT00822731|Drug|Chemotherapy with or without radiotherapy|Treatment regimen will be determined by the sub-type of lymphoma
16275595|NCT00822705|Drug|Placebo tablet|Control arm
16275596|NCT00822692|Drug|Trim/ Sulfa DS|bactrim DS (800/160) two tablets PO BID x 7 days
16275597|NCT00822692|Drug|placebo|matched placebo 2 pills PO BID x 7 days
16275748|NCT00821691|Drug|Amantadin|Amantadin caps
16275598|NCT00822679|Drug|Eszopiclone|Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older.
16275599|NCT00822679|Other|Placebo|Subjects are given placebo for 3 consecutive nights
16275600|NCT00822666|Drug|clopidogrel|comparison of two loading strategies of clopidogrel (300mg vs 900mg) in the two genetic profiles
16275601|NCT00822653|Device|Calf Muscle Pump Stimulation|Stimulation of the postural reflex arc to activate the soleus muscle during dialysis
16275602|NCT00822640|Device|Total Knee Arthroplasty|All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.
16275603|NCT00822627|Drug|Influenza Vaccination|0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
16275604|NCT00822627|Behavioral|Education and referral|Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination
16275605|NCT00822614|Drug|Fentanyl TAIFUN|Inhalation of Fentanyl via TAIFUN inhaler
16275606|NCT00822614|Drug|Opioid|Current optimized BTP treatment
16275607|NCT00822601|Device|rTMS|Arm 1 (experimental) : rTMS, 4 weeks of stimulation with RMT frequency 1Hz, intensity 100% of RMT for 20 minutes (1500 pulses), 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks.
16275608|NCT00822601|Device|Sham Comparator|sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
16275609|NCT00822588|Device|Sangvia® System|Sangvia® Intra- and Post-op System
16275610|NCT00822575|Device|ZapperClick|The ZapperClick is a therapeutic device that employs the piezo-electricity principle to soothe itching and ease the swelling from mosquito and horsefly bites as well as jellyfish and nettle stings. It accomplishes this by discharging 13KV at 0.7mA for 10 microseconds over the area of the bite or sting each time it is activated.
16275611|NCT00822562|Other|PRFA or PMCT|PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles
16275612|NCT00822562|Procedure|surgery|only surgery
16275613|NCT00822549|Drug|intravenous morphine titration|intravenous morphine titration
16275614|NCT00822536|Drug|Aspirin and Clopidogrel|Aspirin <= 325 mg/j Clopidogrel = 75 mg /j
16275615|NCT00822536|Drug|Aspirin|Aspirin : <= 325 mg/j
16275616|NCT00822523|Drug|Botulinum Toxin, Type A|20 units, single dose, intramuscular in right EDB muscle
16275617|NCT00822523|Drug|Botulinum Toxin, Type A|2 units, single dose, intramuscular to right EDB muscle
16275618|NCT00822523|Drug|Saline|Single Dose, Intramuscular into right EDB muscle
16275619|NCT00822510|Behavioral|Telephone Interpersonal Counseling|Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
16275620|NCT00822510|Behavioral|Telephone delivered education only|Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
16275621|NCT00822497|Behavioral|Music-Based Imagery (MBI)|MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.
16275622|NCT00822497|Behavioral|Music Alternate Engagement (MAE)|MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.
16275623|NCT00822484|Biological|ILV-095|
16275624|NCT00822484|Other|Placebo|
16275625|NCT00822471|Behavioral|Diabetes Self-Management Education|"DSME intervention consisting of two interactive 2-1/2 hour classes taught by a diabetes educator focusing on the ABCs of diabetes and training in how to talk to your doctor."
16275626|NCT00822458|Drug|vismodegib|Given orally
16275627|NCT00822458|Other|laboratory biomarker analysis|
16275628|NCT00822458|Other|pharmacological study|
16275629|NCT00822419|Drug|lidocaine|lidocaine cream 5%
16275630|NCT00822419|Drug|ketamine|ketamine 5%
16275631|NCT00822419|Drug|non-drug cream|will be put on the skin
16275632|NCT00822406|Drug|homeopathic medicine|individualized homeopathic medicine
16275633|NCT00822406|Drug|placebo|placebo - 6 months
16275634|NCT00822393|Drug|Busulfan|4 x 0.8 mg/kg/d Intravenous Day -4 and -3
16275635|NCT00822393|Drug|Treosulfan|10 g/m2/d Intravenous Day -4, -3, -2
16275636|NCT00822380|Dietary Supplement|Iron|Daily 20mg of ferrous sulfate in liquid solution during 4 months
16275637|NCT00822380|Dietary Supplement|Multiple micronutrients supplement|Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.
16275638|NCT00822380|Dietary Supplement|micronutrient fortified porridge powder|Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months
16275639|NCT00822380|Dietary Supplement|Iron and ascorbic acid fortified water|A drink water product fortified with 6.7 mg ofiron, zinc and ascorbic acid. This product was asked to be used for drinking and for cooking for the child during 4 months.
16275640|NCT00822380|Dietary Supplement|Iron plus folic acid supplement|Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months
16275641|NCT00822367|Dietary Supplement|Glucerna; Ensure; SlimFast|Each participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days.
16275642|NCT00822354|Drug|Tadalafil|Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil
16275643|NCT00822341|Drug|TG-0054|0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion
16275644|NCT00822328|Dietary Supplement|Yakult®300|"Yakult®300 was given 100 ml once per day for four weeks.
~Fermented or unfermented milk per 100 ml bottle per day for four week."
16275645|NCT00822328|Dietary Supplement|Lactobacillus casei strain Shirota|Lactobacillus casei strain Shirota
16275646|NCT00822315|Drug|efavirenz|tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg
16275647|NCT00822315|Drug|raltegravir|tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg
16275648|NCT00822315|Drug|raltegravir|tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg
16275649|NCT00822302|Drug|Reconstituted High Density Lipoprotein|RecHDL (Lot Nos 05422-00006)is provided as a lyophilised powder and reconstituted with sterile water at 25 mg/ml. The infusion is made at 40 mg/kg over a period of 4 hours.
16275650|NCT00822302|Drug|Saline|Saline (0.9%) is provided as a sterile infusion bag and infused over a period of 4 hours, 24 hours prior to carotid endarterectomy
16275651|NCT00822263|Drug|N-acetyl-cysteine (NAC)|Anti-oxidant in a pill format
16275652|NCT00822263|Drug|Placebo|Control for study
16275653|NCT00822250|Other|analysis of pigmentation|cutting hair, skin description, skin biopsy for only 4 patients
16275654|NCT00822237|Biological|Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)|VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
16275655|NCT00822237|Biological|Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)|VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
16275656|NCT00822237|Biological|Measles, Mumps, and Rubella Virus Vaccine Live (MMR)|M-M-R II in two 0.5 mL doses by injection ~6 weeks apart
16275657|NCT00822224|Drug|MEOPA|inhalation of MEOPA during the painful care
16275658|NCT00822211|Drug|Vildagliptin 50 mg bid|
16275659|NCT00822211|Drug|Vildagliptin 50 mg qd|
16275660|NCT00822211|Drug|Placebo|
16275661|NCT00822198|Device|plantar vibration|Subjects in the experimental component of the trial will be provided with a Juvent 1000-CS device in their home or workplace. The device will be placed in a convenient location where the device does not represent a trip hazard, and yet is readily accessible for use. The subjects will be instructed to use the device whenever it is convenient to do so, either by standing on the device, or by sitting with their feet on the device. Downloads of usage data will be obtained intermittently. Period interviews with the subjects will be conducted to ensure that the device is operating and that no problems are encountered with device usage.
16275662|NCT00822185|Drug|vatreptacog alfa (activated)|One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
16275663|NCT00822185|Drug|vatreptacog alfa (activated)|One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
16275664|NCT00822185|Drug|vatreptacog alfa (activated)|One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
16275665|NCT00822185|Drug|vatreptacog alfa (activated)|One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
16275666|NCT00822185|Drug|placebo|Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
16275667|NCT00822185|Drug|placebo|Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
16275668|NCT00822185|Drug|placebo|Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
16275669|NCT00822185|Drug|placebo|Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
16275670|NCT00822172|Dietary Supplement|Levocarnitine tartrate|Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.
16275671|NCT00822172|Drug|cilostazol|"Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.
~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
16275672|NCT00822159|Device|DensiProbe Hip|DensiProbe (CE marked) is a mechanical probe, which is used intra-operatively to assess mechanical stability of the trabecular bone in the proximal femur. It consists of a drill bit like tool and an electronic system for measuring the peak torque to break-away of trabecular bone in the femoral head. DensiProbe measurements are designed to be integrated in the DHS surgical procedure.
16275673|NCT00822146|Device|CRT|classified
16275674|NCT00822133|Drug|lidocaine|lidocaine 5%
16275675|NCT00822133|Drug|ketamine|ketamine cream
16275676|NCT00822133|Drug|non-active drug cream|will be put on the skin
16275677|NCT00822120|Biological|bleomycin sulfate|
16275678|NCT00822120|Biological|filgrastim|
16275679|NCT00822120|Drug|ABVD regimen|
16275680|NCT00822120|Drug|BEACOPP regimen|
16275681|NCT00822120|Drug|cyclophosphamide|
16275682|NCT00822120|Drug|dacarbazine|
16275683|NCT00822120|Drug|doxorubicin hydrochloride|
16275684|NCT00822120|Drug|etoposide|
16275685|NCT00822120|Drug|prednisone|
16275686|NCT00822120|Drug|procarbazine hydrochloride|
16275687|NCT00822120|Drug|vinblastine sulfate|
16275688|NCT00822120|Drug|vincristine sulfate|
16275689|NCT00822107|Drug|Hydrochlorothiazide|50 mg one time
16275690|NCT00822094|Drug|CPX-351|
16275691|NCT00822094|Drug|Intensive Salvage Therapy|
16275692|NCT00822081|Drug|brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination|1 drop BID in each eye
16275693|NCT00822081|Drug|dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination|1 drop BID in each eye
16275694|NCT00822081|Drug|brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.|1 drop BID in each eye
16275695|NCT00822081|Drug|dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.|1 drop BID in each eye
16275696|NCT00822068|Device|anodal tDCS|anodal transcranial direct current stimulation
16275697|NCT00822068|Device|cathodal tDCS|cathodal transcranial direct current stimulation
16275698|NCT00822068|Device|sham stimulation|sham stimulation
16275699|NCT00822055|Drug|brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination|1 drop BID in each eye
16275700|NCT00822055|Drug|dorzolamide hcl 2%/timolol maleate 0.5% fixed combination|1 drop BID in each eye
16275701|NCT00822055|Drug|brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy|1 drop BID in each eye
16275702|NCT00822055|Drug|dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy|1 drop BID in each eye
16275749|NCT00821691|Drug|Placebo|Placebo caps
16275703|NCT00822042|Other|Samples and procedures|"Scanner, histomorphometry : at the inclusion and M3 visits
~whole blood samples, cytoponction : at the inclusion and M3 visits"
16275704|NCT00822029|Drug|FOSAMAX|patient receiving one tablet (oral use) 70 mg Fosamax by week
16275705|NCT00822029|Other|PLACEBO|patient receiving one tablet (oral use) placebo by week
16275706|NCT00822003|Drug|Oral GLP-1|GLP-1 tablet (2mg)
16275707|NCT00822003|Drug|Placebo|Control tablet
16275708|NCT00821990|Drug|Chemotherapy|The administration of chemotherapy regimen (docetaxel or irinotecan) will be determined at the discretion of investigator, and depends on the patient's previous chemotherapy.
16275709|NCT00821990|Other|Best supportive care|It includes nutritional support, analgesics, antibiotics, antiemetics, transfusions, or any other symptomatic therapy (with the exception of cytotoxic chemotherapy) and/or assistance of a psychological support. Localized radiotherapy to alleviate symptoms such as pain is allowed provided that the total dose delivered is in a palliative range.
16275710|NCT00821977|Drug|Vildagliptin|
16275711|NCT00821977|Drug|Vildagliptin|
16275712|NCT00821977|Drug|Placebo|
16275713|NCT00821964|Drug|imiquimod|Given topically
16275714|NCT00821964|Drug|Abraxane|Given IV
16275715|NCT00821964|Other|laboratory biomarker analysis|Correlative studies
16275716|NCT00821964|Genetic|RNA analysis|Correlative studies
16275717|NCT00821964|Other|immunoenzyme technique|Correlative studies
16275718|NCT00821951|Drug|Vorinostat|200 mg, 300 mg, 400 mg, once per RT fraction
16275719|NCT00821951|Radiation|Radiotherapy|Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.
16275720|NCT00821938|Procedure|LV dp/dt pressure measurement|Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
16275721|NCT00821938|Procedure|LV dp/dt pressure measurement|Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment
16275722|NCT00821925|Procedure|bone densitometry|All patients do a bone densitometry after the inclusion.
16275723|NCT00821912|Drug|Docetaxel|30 mg/m2, administered as a 30 min. i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule
16275724|NCT00821912|Drug|Capecitabine|1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
16275725|NCT00821899|Biological|administration of autologous bone marrow blood|administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period
16275726|NCT00821886|Drug|Ixabepilone|Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
16275727|NCT00821886|Drug|Trastuzumab|Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
16275728|NCT00821886|Drug|Carboplatin|Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)
16275729|NCT00821873|Other|CR Plug|CR Plug will be placed in the harvest site
16275730|NCT00821860|Other|talc|Talc pleurodesis
16275731|NCT00821860|Procedure|therapeutic thoracoscopy|Talc pleurodesis via thoracoscopy
16275732|NCT00821860|Procedure|therapeutic videothoracoscopy|Video-assisted thoracoscopic pleurectomy
16275733|NCT00821847|Other|DEXA scan|DEXA scan
16275734|NCT00821834|Drug|clopidogrel (SR25990)|"Form: tablets
~Route: oral"
16275735|NCT00821834|Drug|ticlopidine|"Form: tablets
~Route: oral"
16275736|NCT00821834|Drug|Placebo|"Form: tablets
~Route: oral"
16275737|NCT00821821|Drug|MCI-186|"Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion
~Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion"
16275738|NCT00821821|Drug|Placebo|"Cohort1:circa 1000mg / 72-hour infusion matching placebo
~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
16275739|NCT00821808|Device|Compression Device|"The compression device will be worn for 8 hours each day on one leg. The device will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals:
~Immediately following device application
~1 hour
~4 hours
~8 hours"
16275740|NCT00821808|Device|Profore®|"Profore® will be worn for 8 hours each day on opposite leg. Profore® will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals:
~Immediately following device application
~1 hour
~4 hours
~8 hours"
16275741|NCT00821795|Drug|NPH/Regular 70/30 mix|injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
16275742|NCT00821795|Drug|insulin aspart protamine/insulin aspart 70/30 mix|injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
16275743|NCT00821782|Drug|Levofloxacin; Azithromycin|
16275744|NCT00821756|Behavioral|OPAC (Outreach, Problem solving, Adherence, Continuity)|Assertive outreach immediately after the suicide attempt with about 8 home visits plus contact by telephone, phone messages, e-mails. Duration of intervention 6 months.
16275745|NCT00821743|Device|Deep brain stimulation electrode|The DBS electrodes (model 3389, Medtronic) will be stereotactically implanted bilaterally in the PPN, according to the technique usually used for STN-DBS, and connected to the subcutaneously implanted stimulator (Kinetra, Medtronic).
16275746|NCT00821717|Drug|Ferinject ® (Ferric carboxymaltose)|"Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.
~After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase)."
16275747|NCT00821717|Drug|Normal saline (0.9%)|During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
16275750|NCT00821678|Other|Telemedicine Outreach for PTSD|The intervention involves an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and uses telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager educates/activates patients, identifies preferences, overcomes treatment barriers, monitors symptoms, side-effects and adherence, identifies psychiatric comorbidities, and encourages patient self-management. Tele-pharmacists provide medication management by phone. Tele-psychologists provide Cognitive Processing Therapy via interactive video. Tele-psychiatrists supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.
16275751|NCT00821665|Dietary Supplement|Sucrose consumption|Sucrose
16275752|NCT00821665|Dietary Supplement|water consumption|water
16275753|NCT00821652|Drug|NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod|Part I: a cohort of 3 patients to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical resiquimod 1000 mg of the 0.2% gel on days 1, and 3. If no DLT observed, we will proceed to cohort 2 with Resiquimod dosing on days 1,3 and 5. If DLT is found in the second cohort, the trial will proceed to Part II; with the limited dosing for days 1 and 3 only, as used in the first cohort. If no DLT is found in second cohort, the trial will proceed to Part II with Resiquimod dosing for days1, 3 and 5.
16275754|NCT00821652|Drug|NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo|Part II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I. The cycles will be repeated every 3 weeks for a total of 4 cycles (on Study week 1, 4, 7 and 10). All procedures may occur within + 3 days of the planned date.
16275755|NCT00821639|Behavioral|Counseling, educational pamphlet and a sticker|Infants exposed to secondhand smoke will be recruited and randomized based on parents to receive or not receive counseling, an educational pamphlet and a sticker on SHS.
16275756|NCT00821626|Device|BD Directigen EZ Flu A+B|Naso-pharyngeal swab and rapid flu test
16275757|NCT00821626|Other|Control|No rapid flu test
16275758|NCT00821600|Drug|risperidone IR and LAI formulation|1 mg risperidone IR single injection, followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection
16275759|NCT00821587|Drug|Cyclosporine|Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
16275760|NCT00821587|Drug|Tacrolimus|Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.
16275761|NCT00821574|Drug|Fluvastatin|Fluvastatin: daily 80 mg, oral
16275762|NCT00821574|Drug|Valsartan|Valsartan: daily 160 mg, oral
16275763|NCT00821574|Drug|Hydrochlorothiazide|Hydrochlorothiazide: daily 12.5mg, oral
16275764|NCT00821561|Drug|Nexagon®|
16275765|NCT00821561|Drug|Nexagon® vehicle|
16275766|NCT00821548|Procedure|electrostimulation|Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients
16275767|NCT00821535|Drug|maraviroc (Selzentry, Celsentri)|12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.
16275768|NCT00821522|Procedure|Remote Ischemic Preconditioning|Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
16275769|NCT00821509|Behavioral|Hand washing|Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home
16275770|NCT00821509|Behavioral|Disinfectant rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
16275771|NCT00821496|Drug|ethinyl estradiol, norethindrone, VI-0521|Oral contraceptive
16275772|NCT00821483|Drug|Frovatriptan|2.5mg, qd
16275773|NCT00821470|Procedure|core decompression|core decompression procedure only
16275774|NCT00821470|Procedure|Bone marrow implantation into the necrotic lesion|
16275775|NCT00821457|Drug|Juvista|250ng
16275776|NCT00821457|Drug|Placebo|Powder for solution for injection
16275777|NCT00821457|Drug|Juvista|500ng
16275778|NCT00821444|Drug|ziprasidone|40 mg capsule, single dose x 3
16275779|NCT00821444|Drug|B16 Fasted|40 mg tablet, single dose X 3
16275780|NCT00821444|Drug|B16 Fed|40 mg tablet, single dose X 3
16275781|NCT00821431|Device|Compression Device|"Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
16275782|NCT00821431|Device|Profore|Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.
16275783|NCT00821418|Device|PulseHaler treatment|treatment is for two weeks, 3 times per day
16275784|NCT00821418|Device|CPAP treatment (through a deactivated version of PulsHaler)|treatment is for two weeks, 3 times per day
16275785|NCT00821392|Drug|Febuxostat|
16275786|NCT00821366|Behavioral|ARV peer adherence support (PAS)|Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support
16275787|NCT00821366|Dietary Supplement|Nutritional support|Weekly delivery by peer adherence supporter (PAS) of two 400g cans of meatballs and spaghetti in tomato sauce
16275788|NCT00821366|Drug|ARV treatment|Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme
16275789|NCT00821353|Procedure|RF catheter ablation|RF catheter ablation
16275790|NCT00821353|Drug|Antiarrhythmic drugs|One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
16275791|NCT00821340|Genetic|rAAV2-hRPE65|Uniocular subretinal injections; relative doses: Cohort 1 - basic (lowest) viral dose; Cohort 2 - higher (1.5 times basic) viral dose; Cohort 3 - patients 8-17 years of age will receive basic viral dose; patients 18 years of age and over will receive higher dose;
16275792|NCT00821327|Drug|Gemcitabine, Cisplatin, Sunitinib|"Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
16275793|NCT00821301|Drug|Fluphenazine HCl|Fluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle.
16275794|NCT00821288|Behavioral|Survivorship Intervention|"Survivorship Consultation is a one hour consultation in a survivorship clinic. The consultation will be performed by a nurse practitioner under the supervision of a medical oncologist. The consultation will result in a detailed written document outlining the individuals Survivorship Prescription including treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations. This written document will be provided to the patient and her treating physician. In addition, referrals will be made to appropriate adjunct services as needed (e.g. psychologist, nutritionist, social worker)."
16275795|NCT00821288|Behavioral|Facing Forward|Facing Forward: Life after Cancer Treatment is a guide for people who were treated for cancer published by the NCI. It is a 24-page manual that summarized many key issues of interest to cancer survivors during the re-entry phase, and contains sections on medical care after treatment, symptoms after treatment, feelings after treatment, social relationships after cancer treatment, and dealing with practical matters such as insurance and employment. The manual is available in English and Spanish. This will be given at the time of registration and the table of contents will be reviewed with the patient.
16275796|NCT00821275|Procedure|Interventional radiological or surgical management|Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.
16275797|NCT00821262|Drug|sevoflurane|
16275798|NCT00821262|Drug|propofol|
16275799|NCT00821249|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
16275800|NCT00821249|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.
16275801|NCT00821249|Drug|Dexamethasone, steroid; oral|Part 3: standard of care.
16275802|NCT00821236|Device|Excimer Laser|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
16275803|NCT00821236|Device|AMO/VISX CustomVue™|Excimer Laser
16275804|NCT00821236|Device|LADARVision 4000 excimer laser|Excimer Laser
16275805|NCT00821223|Procedure|phacoemulsification and SICS|SICS with rigid IOL implantation Phaco with foldable IOL implantation
16275806|NCT00821223|Procedure|manual small incision surgery|
16275807|NCT00821223|Procedure|phacoemulsification|cataract surgery
16275808|NCT00821210|Device|Sham CPAP|CPAP with pressure of 3cm H2O
16275809|NCT00821210|Device|CPAP of optimal pressure|CPAP of optimal pressure
16275810|NCT00821197|Procedure|long-limb gastric bypass|Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
16275811|NCT00821197|Procedure|distal gastric bypass|Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
16275812|NCT00821184|Drug|Vesicare (solifenacin)|5mg po qd
16275813|NCT00821184|Behavioral|Vesicare (solifenacin) plus behavioral modification|5 mg dose po once daily plus behavioral modification
16275814|NCT00821158|Drug|Antioxidant|Antioxidant iv bolus
16275815|NCT00821158|Other|Placebo|Placebo tablet and iv
16275816|NCT00821158|Drug|Anti-inflammatory drug|Anti-inflammatory tablet
16275817|NCT00821145|Procedure|conventional surgery|AAA patients operated using a conventional incision
16275818|NCT00821145|Procedure|laparoscopic AAA resection|laparoscopic AAA resection
16275819|NCT00821145|Procedure|laparoscopic stapler anastomosis|laparoscopic AAA resection, proximal anastomosis performed with a stapler
16275820|NCT00821132|Other|Genetic study of ALS families|Collection and analysis of genetic material, medical and family histories from families with ALS
16275821|NCT00821119|Device|nasal intermittent positive pressure ventilation|Nasal intermittent positive airway pressure will be compared are the nasal continuous positive pressure as an initial ventilatory mode in preterm infants with respiratory distress syndrome
16275822|NCT00821106|Procedure|Right radial|diagnostic or interventional procedures performed through right transradial approach
16275823|NCT00821106|Procedure|left radial|diagnostic or interventional procedures performed through left transradial approach
16275824|NCT00821093|Drug|Indacaterol 150 µg|Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16275825|NCT00821093|Drug|Salmeterol 50 µg|Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
16275826|NCT00821093|Drug|Placebo to indacaterol|Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16275827|NCT00821093|Drug|Placebo to salmeterol|Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
16275828|NCT00821080|Drug|Sirolimus|Taken orally at different dose levels depending upon enrollment time period
16275829|NCT00821080|Drug|Vandetanib|Taken orally at different dose levels depending upon enrollment time period
16275830|NCT00821067|Dietary Supplement|D-ribose|A 6 gm/day (3 gm/bid) dose of D-ribose in water. Each subject will consume oral D-ribose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
16275831|NCT00821067|Dietary Supplement|Dextrose|A 6 gm/day (3 gm/bid) dose of dextrose in water. Each subject will consume oral dextrose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
16275832|NCT00019539|Drug|bevacizumab|
16275833|NCT00019539|Drug|thalidomide|
16275834|NCT00821054|Drug|Lapatinib|Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.
16275835|NCT00821041|Behavioral|Cognitive Behavioral Therapy|6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
16275836|NCT00821028|Drug|Paclitaxel|Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery. Dosing will be based on ther lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
16275837|NCT00821015|Device|Pulmonary vein isolation with cryoballoon catheter|For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient.
16275838|NCT00821002|Drug|Latanoprost|Comparison of punctal plug placement between upper and lower puncta
16275839|NCT00820989|Biological|Endotoxin, Lipopolysaccharide, LPS|Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
16275840|NCT00820976|Drug|G-CSF|Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery
16275841|NCT00820963|Drug|temozolomide|Given orally
16275842|NCT00820963|Radiation|hypofractionated radiation therapy|Patients undergo hypofractionated radiotherapy
16275843|NCT00820963|Radiation|radiation therapy|Patients undergo standard radiotherapy
16275844|NCT00820950|Drug|Ruxolitinib phosphate cream|Ruxolitinib phosphate cream 0.5%
16275845|NCT00820950|Drug|Dovonex® calcipotriene 0.005%|Cream applied once or twice daily for up to 56 days.
16275846|NCT00820950|Drug|Diprolene® AF betamethasone dipropionate 0.05% cream.|Cream applied once or twice daily for up to 56 days
16275847|NCT00820950|Drug|Placebo cream|Cream applied once or twice daily for 56 days
16275848|NCT00820950|Drug|Ruxolitinib phosphate cream|Ruxolitinib phosphate cream 1.0%
16275849|NCT00820950|Drug|Ruxolitinib phosphate cream|Ruxolitinib phosphate cream 1.5%
16275850|NCT00820937|Procedure|Single photon emission computed tomography and Magnetic Resonance Imaging|
16275851|NCT00820924|Drug|LAPATINIB|LAPATINIB 1500MG ORAL DOSE DAILY
16275852|NCT00820911|Drug|cyclosporine (reduced exposure) / everolimus|twice daily
16275853|NCT00820911|Drug|AEB071 300 mg b.i.d. / everolimus|twice daily
16275854|NCT00820911|Drug|AEB071 200 mg b.i.d. / everolimus|twice daily
16275855|NCT00820898|Drug|Gemcitabine Hydrochloride|Given IV
16275856|NCT00820885|Drug|teduglutide|subcutaneous injection given once a day in the abdomen. Drug is lypholized powder.
16275857|NCT00820885|Drug|teduglutide|Once daily subcutaneous injection in the abdomen. Drug is lypholized powder reconstituted with sterile water
16275858|NCT00820885|Drug|tedguglutide|lypholized powder reconstituted with sterile water and injection subcutaneously once a day in the abdomen.
16275859|NCT00820872|Biological|trastuzumab|
16275860|NCT00820872|Drug|carboplatin|
16275861|NCT00820872|Drug|docetaxel|
16275862|NCT00820872|Drug|lapatinib ditosylate|
16275863|NCT00820859|Behavioral|TREA (Treatment Routes for Exploring Agitation)|Individualized non-pharmacological treatment plan for agitation
16275864|NCT00820859|Behavioral|Placebo Control Group|A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group
16275865|NCT00820846|Biological|pGA2/JS7 DNA vaccine|1 mL of pGA2/JS7 DNA vaccine
16275866|NCT00820846|Biological|Placebo|1 mL of sodium chloride for injection
16275867|NCT00820846|Biological|MVA/HIV62 vaccine|1 mL of recombinant modified vaccinia Ankara/HIV clade B gag-pol-env (MVA/HIV62)
16275868|NCT00820833|Other|standard infant formula|standard infant formula given from 3 to 12 months of age, as per standard requirement
16275869|NCT00820833|Other|Test formula|Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
16275870|NCT00820820|Biological|ROUVAX|Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
16275871|NCT00820820|Biological|placebo|Vehicle (water for injection), 0.5 ml, once
16275872|NCT00820807|Other|Novel dietary fiber|oral consumption in beverage
16275873|NCT00820807|Other|Novel dietary fiber|oral consumption in beverage
16275874|NCT00820807|Other|Placebo|oral consumption in beverage
16275875|NCT00820794|Drug|Lithium|300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
16275876|NCT00820794|Drug|PD 0332334|225 mg q12h PD 0332334, oral, 9 days treatment
16275877|NCT00820794|Drug|Lithium|300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
16275878|NCT00820794|Drug|PD 0332334|225 mg q12h PD 0332334, oral, 9 days treatment
16275879|NCT00820781|Procedure|Portacaval shunt|Subject taken to the operating room and undergoes portacaval shunt surgery
16275880|NCT00820781|Procedure|Sclerotherapy|Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy
16275881|NCT00820768|Drug|ABI-010|17-AAG and ABI-007
16275931|NCT00820430|Other|Magnetic Resonance Imaging|Subjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho).
16275932|NCT00820417|Drug|Cetuximab/Gefitinib combination and/or monotherapy|
16275882|NCT00820755|Drug|Cetuximab plus Platinum-based Doublet Chemotherapy|Single first dose of cetuximab 400 mg/m^2 infusion will be administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min q1w with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy will be administered as intravenous infusion as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 milligram*hour/milliliter (mg*hr/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*hr/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
16275883|NCT00820755|Drug|Cetuximab 500 mg/m^2|Subjects who will be free of disease progression at the end of combination therapy, will enter in the maintenance therapy period. In the maintenance period, subjects will be receive cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
16275884|NCT00820755|Drug|Cetuximab 250 mg/m^2|Subjects who will free of disease progression at the end of combination therapy, will enter in the maintenance therapy period. In the maintenance period, subjects will be receive cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
16275885|NCT00820742|Drug|Macugen|Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks
16275886|NCT00820716|Other|Exercise training|Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities
16275887|NCT00820703|Drug|Nexagon®|
16275888|NCT00820703|Drug|Nexagon® vehicle|
16275889|NCT00820690|Drug|doxorubicin|4 cycles AC: doxorubicin 60mg/m2
16275890|NCT00820690|Drug|cyclophosphamide|4 cycles AC: cyclophosphamide 600mg/m2
16275891|NCT00820690|Drug|paclitaxel|4 cycles T: paclitaxel 175mg/m2 after 4 AC
16275892|NCT00820690|Procedure|Surgery|"The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported.
~The oncoplastic surgery rate will be reported"
16275893|NCT00820677|Behavioral|DVD/Video|One DVD or Video will be watched by all parents of newborns enrolled into the experimental group.
16275894|NCT00820664|Drug|Comparator: Estrace 0.5 mg|0.5 mg tablet taken once daily for 28 days
16275895|NCT00820664|Drug|Comparator: Estrace 2 mg|2 mg tablets taken once daily for 28 days.
16275896|NCT00820664|Drug|Comparator: Placebo|Placebo 0 mg capsule taken once daily for 28 days
16275897|NCT00820651|Dietary Supplement|Diamel|Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
16275898|NCT00820651|Other|Placebo and lifestyle counseling|Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with <10% of saturated fatty acids and protein 14%, and exercise)
16275899|NCT00820638|Device|myomo e100|use of the myomo e100 in home
16275900|NCT00820625|Procedure|pulmonary vein isolation|common pulmonary vein isolation procedure
16275901|NCT00820625|Procedure|pulmonary vein isolation with additional ablation of fragmented potentials|common pulmonary vein isolation with additional but also common ablation of fragmented potentials
16275902|NCT00820612|Drug|Indomethacin|100 mg PR once at the time of ERCP
16275903|NCT00820612|Other|Placebo suppositories|2 placebo suppositories at the time of ERCP
16275904|NCT00820599|Device|Sapien XT™ transcatheter heart valve and delivery system|
16275905|NCT00820586|Procedure|Mononuclear bone marrow derived cells|Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells
16275906|NCT00820573|Drug|Sitagliptin|tablet, 100 mg/day, 6 weeks
16275907|NCT00820573|Drug|Metformin|tablet, 1000 mg/ bid, 6 weeks
16275908|NCT00820573|Drug|Sitagliptin + Metformin|tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks
16275909|NCT00820573|Drug|Placebo|Placebo 6 weeks
16275910|NCT00820560|Drug|INCB007839|INCB007839 100 or 200 mg/dose as IR capsules
16275911|NCT00820547|Biological|bevacizumab|During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cycles
16275912|NCT00820547|Drug|cyclophosphamide|Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
16275913|NCT00820547|Drug|docetaxel|Neoadjuvant: 100 mg/m2 q3w, 4 cycles
16275914|NCT00820547|Drug|epirubicin hydrochloride|Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
16275915|NCT00820547|Drug|fluorouracil|Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
16275916|NCT00820534|Drug|Penciclovir|Penciclovir every 2 hours during waking hours for 96 hours
16275917|NCT00820534|Drug|Placebo|Placebo every 2 hous during waking hours for 96 hours
16275918|NCT00820521|Drug|active|
16275919|NCT00820521|Drug|placebo|
16275920|NCT00820508|Drug|CHR-2845|Once daily oral ingestion of capsules (10, 40 or 80mg), dose depending on cohort, treatment cycle of 28 days
16275921|NCT00820495|Behavioral|Web + Phone|Web + Phone
16275922|NCT00820495|Behavioral|Web Only|Web Only
16275923|NCT00820495|Behavioral|Phone Only|Phone Only
16275924|NCT00820495|Behavioral|Usual Care|Usual Care
16275925|NCT00820482|Drug|Menopur®, Ferring|75 UI/day of Hp-hMG (Menopur®)
16275926|NCT00820482|Drug|rFSH (Gonal®,|75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)
16275927|NCT00820469|Drug|Rituximab 375|rituximab 375 mg/m2 IV weekly, during 4 weeks
16275928|NCT00820469|Drug|rituximab 1000|rituximab 1000 mg IV, two infusions on day 1 and day 15
16275929|NCT00820456|Other|DCE-MRI|Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.
16275930|NCT00820443|Device|Ceramic on metal prosthesis|Ceramic femoral head with a metal acetabular component
16275933|NCT00820404|Drug|BLI-489|
16275934|NCT00820404|Drug|Placebo|
16275977|NCT00820105|Drug|ADX10059|Oral administration
16275978|NCT00820105|Drug|ADX10059 Matching Placebo|Oral administration
16275935|NCT00820391|Behavioral|KIDNET|Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events
16275936|NCT00820391|Behavioral|Meditation-Relaxation|a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
16275937|NCT00820378|Other|No special interventioin|Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels:
16275938|NCT00820365|Drug|SC12267 (4SC-101)|Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.
16275939|NCT00820352|Drug|bosentan|4 weeks of oral bosentan 62,5 mg b.i.d., followed by 8 weeks of 125 mg b.i.d.
16275940|NCT00820352|Drug|placebo|placebo twice a day for 12 weeks
16275941|NCT00820339|Procedure|Selective Hepatic Vascular Exclusion|Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.
16275942|NCT00820339|Procedure|Pringle's Maneuver|Hepatic pedical clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.
16275943|NCT00820326|Drug|Dolasetron|Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
16275944|NCT00820326|Drug|Placebo|Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
16275945|NCT00820313|Behavioral|Dr. Dean Ornish Program for Reversing Heart Disease|"Exercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week.
~Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day.
~Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based).
~Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program."
16275946|NCT00820300|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.
16275947|NCT00820287|Procedure|Biopsy of testicular tumor|testicular biopsies performed through open surgery
16275948|NCT00820274|Procedure|amniotic membranes|The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way
16275949|NCT00820261|Other|oral rehydration therapy for diarrhea cases|Since rotavirus infection is a viral infection with no drug remedy, diarrhea cases will be managed according to the standard WHO protocol for the management of diarrhea. This will include oral rehydration treatment.
16275950|NCT00820248|Biological|panitumumab|Given IV
16275951|NCT00820248|Drug|cisplatin|Given IV
16275952|NCT00820248|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
16275953|NCT00820248|Radiation|accelerated radiation therapy|Patients undergo accelerated fractionation radiotherapy
16275954|NCT00820248|Radiation|intensity-modulated radiation therapy|Patients undergo radiotherapy
16275955|NCT00820235|Device|OsseoSpeed™|OsseoSpeed™ implant
16275956|NCT00820235|Device|NobelSpeedy™ Replace®|NobelSpeedy™ Replace® implant
16275957|NCT00820235|Device|NanoTite™ Certain® PREVAIL®|NanoTite™ Certain® PREVAIL® implant
16275958|NCT00820222|Drug|capecitabine|oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle
16275959|NCT00820222|Drug|lapatinib|oral medication; daily dose taken once a day
16275960|NCT00820222|Drug|trastuzumab|infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks
16275961|NCT00820196|Drug|Nexagon®|
16275962|NCT00820196|Drug|Nexagon® vehicle|
16275963|NCT00820183|Other|Quality Improvement plan for Hypertension Control|"Implementation of a plan of quality improvement addressed to health professionals in Primary Health Care Teams. It includes:
~Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation"
16275964|NCT00820170|Drug|Dasatinib and Paclitaxel|"A treatment cycle will consist of 28 days, according to the following schedule:
~Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
~The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel."
16275965|NCT00820157|Procedure|Cytoreductive Surgery|Cytoreductive Surgery followed by TACE for MNHCC
16275966|NCT00820157|Procedure|TACE|TACE alone or TACE followed by downstage resection for MNHCC
16275967|NCT00820144|Biological|CTB by nasal way|
16275968|NCT00820144|Biological|absorption of CTB by oral way|absorption of CTB by oral way
16275969|NCT00820144|Biological|absorption of dukoral by oral way|absorption of dukoral by oral way
16275970|NCT00820144|Biological|absorption of CTB by sublingual way|absorption of CTB by sublingual way
16275971|NCT00820144|Biological|absorption of CTB by sublingual way|absorption of CTB by sublingual way
16275972|NCT00820131|Procedure|selfgrip mesh|inguinal hernia repair using a selfgrip mesh
16275973|NCT00820131|Procedure|lightweight mesh with suture fixation|inguinal hernia repair using a lightweight mesh with suture fixation
16275974|NCT00820118|Drug|Structured treatment interruption|"The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir
~Usual dosage recommended :
~atazanavir : 300 mg/d
~ritonavir : 100 mg/d
~abacavir 600 mg and lamivudine 300 mg : once a day
~tenofovir 245 mg and emtricitabine 200 mg : once a day"
16275975|NCT00820105|Drug|ADX10059|oral administration
16275979|NCT00820092|Drug|Xerecept 1.0|24 hour infusion
16275980|NCT00820092|Drug|Xerecept 2.0|24 hour infusion
16275981|NCT00820092|Drug|Xerecept 3.0|24 hour infusion
16275982|NCT00820079|Drug|ADX10059|oral administration
16275983|NCT00820079|Drug|ADX10059 Matching Placebo|oral administration
16275984|NCT00820053|Drug|epirubicin and lipiodol|using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.
16275985|NCT00820040|Device|acellular porcine dermal collagen mesh|porcine mesh for hernia repair/ abdominal wall reconstruction
16275986|NCT00820027|Drug|Etoricoxib 90 mg|One 90 mg tablet once daily
16275987|NCT00820027|Drug|Etoricoxib 120 mg|Two 60 mg tablets once daily
16275988|NCT00820027|Drug|Ibuprofen 600 mg|One tablet three times daily
16275989|NCT00820027|Drug|Matching Placebo for Etoricoxib 120 mg|Two tablets once daily
16275990|NCT00820027|Drug|Matching Placebo for Etoricoxib 90 mg|One tablet once daily
16275991|NCT00820027|Drug|Matching Placebo for Ibuprofen|One tablet three times daily
16275992|NCT00820027|Drug|Morphine|As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection
16275993|NCT00820027|Drug|Oxycodone|5 mg as needed
16275994|NCT00820014|Drug|Placebo|Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery
16275995|NCT00820001|Behavioral|Booster Treatment|Based on this collective evidence, booster treatment was designed to address three general goals: a) clarify key child and parent/family problems and family preferences regarding target problems, b) directly target and resolve these existing problems using the eight domains contained in the existing treatment protocol administered in the initial outcome study, and c) provide the family with clinical recommendations and information to promote the maintenance of skill developments in targeted domains or adaptive routines designed to prevent any further deterioration in clinical functioning. Thus, the clinician may provide a review of prior content or administer new material specifically for older adolescents, as needed, and will attempt to apply these skills to specific problematic situations identified by the family.
16275996|NCT00820001|Behavioral|No-Booster|All cases randomized to this condition will simply participate in all of the proposed routine assessments and will receive assessment feedback. Specifically, these families will be provided with a brief summary of the significant clinical findings obtained in their 36-month follow-up assessment (assessment feedback). Such an assessment was provided to clinicians in the original study in order to highlight specific areas in need of clinical attention based on a review of the normative data and clinical cutoffs available for each instrument. Selected information will be conveyed by phone to the participating parent/guardian in a straightforward manner followed by a discussion of some clinical recommendations designed to address these clinical problems. In addition, the parent/guardian will be provided with a listing of professionals who provide services appropriate for this age group and for children with similar problems.
16275997|NCT00820001|Other|No intervention|No intervention was administered with this arm. Saliva samples were collected 2 times in the lab and 2 times at home (once at bedtime, once at wake-up time) per initial voluntary saliva protocol at each timepoints to measure endocrine levels.
16275998|NCT00820001|Other|Treatment As Usual|All cases assigned to this arm simply participated in all of the proposed routine assessments.
16275999|NCT00819988|Drug|Pregabalin|Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function
16276000|NCT00819988|Other|Sugar pill|Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
16276001|NCT00819975|Dietary Supplement|Casein|
16276002|NCT00819975|Dietary Supplement|Whey Isolate|
16276003|NCT00819975|Dietary Supplement|Whey Hydrolysate|
16276004|NCT00819975|Dietary Supplement|Alphalact-Albumin|
16276005|NCT00819962|Drug|Bupivacaine|Local anesthetic
16276006|NCT00819962|Other|TAP|
16276007|NCT00819949|Device|Lokomat|The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs through position controlled trajectories that mimic normal human gait patterns. This is accomplished by utilizing high quality computer-controlled motors that are precisely synchronized with the speed of the treadmill. The hip and knee joint angles are controlled in real time by software to achieve kinematically correct stepping behaviors. Each of the four motor-driven joints is individually controlled to correspond precisely to the desired joint angle trajectories. This system assures a precise match between the speed of the limb trajectory and the treadmill. In addition, sensors in the motors provide an indirect indicator of the amount of effort the patient is generating to achieve walking in an upright posture.
16276008|NCT00819936|Procedure|forward walking|comparison forward walking vs backward walking in the physiotherapy after after abdominal surgery
16276009|NCT00819936|Procedure|backward walking|physiotherapy with use a backward walking type of physiotherapy
16276010|NCT00819923|Device|Percutaneous coronary intervention|Intra-coronary stenting
16276011|NCT00819923|Device|Percutaneous coronary intervention|Intra-coronary stenting
16276012|NCT00819910|Drug|Rosiglitazone|Rosiglitazone 8mg daily for 12 weeks
16276013|NCT00819910|Drug|Placebo (Rosiglitazone)|Placebo (Rosiglitazone) 8mg daily for 12 weeks
16276014|NCT00819910|Drug|Placebo (Fenofibrate)|Placebo (Fenofibrate) 145 mg daily for 12 weeks
16276015|NCT00819910|Drug|Fenofibrate|Fenofibrate 145 mg daily for 12 weeks
16276016|NCT00819884|Drug|AZD1656|Oral suspension
16276017|NCT00819858|Dietary Supplement|RUTF (Plumpynut®)|Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
16276018|NCT00819845|Drug|carvedilol|carvedilol vs ramipril
16276019|NCT00819845|Drug|ramipril|carvedilol vs ramipril
16276020|NCT00819832|Procedure|Kyphoplasty|A small fluid balloon will create a hole in the broken back bone where tumor is located. After balloon deflation and removal, hole is filled with medical cement.
16276021|NCT00819832|Procedure|Vertebroplasty|Medical cement will be injected into broken back bone.
16276022|NCT00819832|Device|Cavity SpineWand|Removes tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken back bone(s).
16276023|NCT00819819|Dietary Supplement|Gluten|Purified gluten from exaploid wheat introduced per American Academy of Pediatric Recommendations. Three grams from 6-9 months and 5 grams from 9-12 months. The 3-5 grams represents the mean daily intake of gluten during the second half of the first year in infants of different countries.
16276024|NCT00819819|Dietary Supplement|Gluten free diet|Non gluten containing starch added to diet. Three grams from 6-9 months and 5 grams from 9-12 months. After the age of 1 year all children will be allowed age appropriate unrestricted diet.
16276025|NCT00819806|Biological|Vaccine only|PF-3512676, Montanide ISA 720 VG and MHC class I peptides from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. The remaining 1.5 ml will be used for sterility testing. Each injection will be done in the vicinity of the nodal drainage of one extremity.
16276026|NCT00819806|Biological|Vaccine + cyclophosphamide|PF-3512676, Montanide ISA 720 VG and three MHC class I-restricted epitopes from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) and cyclophosphamide. The vaccine preparation is identical to arm A. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
16276027|NCT00819806|Biological|Vaccine only|PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102) and three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.
16276028|NCT00819806|Biological|Vaccine + cyclophosphamide|PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102), three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) and cyclophosphamide. The vaccine preparation is identical to arm C. Low-dose cyclophosphamide (300mg/m2) IV will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
16276029|NCT00819806|Biological|Vaccine only|PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injection (i.e. 3 mg of PF-3512676 or 300 μl of PF-3512676 at 10mg/ml, 300 μg or 900 μl of protein NY-ESO-1 at 0.35 mg/ml + Montanide ISA 720 VG). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml SC injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.
16276030|NCT00819806|Biological|Vaccine + cyclophosphamide|PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injections and cyclophosphamide. The vaccine preparation is identical to arm E. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
16276031|NCT00819793|Device|CentriMag Ventricular Assist System|All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
16276032|NCT00819780|Drug|Panitumumab|Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).
16276033|NCT00819780|Drug|Bevacizumab|Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).
16276034|NCT00819780|Drug|mFOLFOX6|mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.
16276035|NCT00819767|Drug|Aliskiren|Aliskiren was supplied in 150 mg tablets.
16276036|NCT00819767|Drug|Valsartan|Valsartan was supplied in 160 mg capsules.
16276037|NCT00819767|Drug|Placebo to aliskiren|Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg.
16276038|NCT00819767|Drug|Placebo to valsartan|Placebo to valsartan was supplied in capsules matching valsartan 160 mg.
16276039|NCT00819754|Drug|IXO regimen + bevacizumab|"Phase I study - identifies the safety of IXO with bevacizumab and recommended phase II dose
~Phase II study - assesses efficacy and safety of IXO with bevacizumab"
16276040|NCT00819741|Drug|repaglinide|The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily
16276041|NCT00819741|Drug|metformin|The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily
16276042|NCT00819741|Drug|repaglinide|The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.
16276043|NCT00819728|Drug|Docetaxel|35mg/m2 IV each week for 4 weeks
16276044|NCT00819728|Drug|Irinotecan|50mg/m2 IV each week for 4 weeks
16276045|NCT00819702|Other|Model Care|The Model Care provided training to pediatric health care providers to assess parental psychosocial risk factors to child maltreatment.
16276046|NCT00819676|Other|analysis of exhaled breath by biosensors|
16276047|NCT00819676|Other|measurement of exhaled nitric oxide|
16276137|NCT00819052|Drug|Nevirapine IR|Nevirapine Immediate Release
16276138|NCT00819039|Drug|Aprepitant|Aprepitant administered orally or intraveously.
16276139|NCT00819039|Drug|Ondansetron|Ondansetron administered intravenously.
16276048|NCT00819650|Drug|Licartin (generic name,[131I]metuximab injection)|Licartin, radioiodination of Metuximab with Na[131I],with radiochemical purity above 95% and specific activity between 173.25-288.75 MBq/ml.All patients in the treatment group received Licartin 3 times at an interval of 28 days beginning from the 4th week after liver resection
16276049|NCT00819637|Drug|arformoterol (RR formoterol)|"Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses.
~Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses."
16276050|NCT00819637|Drug|placebo|Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
16276051|NCT00819637|Drug|levalbuterol|Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
16276052|NCT00819624|Other|Interactive Voice Response System (IVRS)|Telephone based system
16276053|NCT00819624|Other|Personal Digital Assisstant (PDA)|Electronic Hand Held diary
16276054|NCT00819611|Behavioral|Cogmed Working memory training|15 minutes of working memory training, 5 days a week for a period of 5 weeks
16276055|NCT00819611|Behavioral|Control version of Cogmed working memory training|15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks
16276056|NCT00819598|Procedure|BLOOD PRESSURE MEASURMENT|Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.
16276057|NCT00819598|Procedure|BLOOD PRESSURE MEASUREMENT|Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.
16276058|NCT00819585|Drug|Canakinumab|Canakinumab was supplied in glass vials as a lyophilized powder.
16276059|NCT00819585|Drug|Colchicine|0.5 mg capsule orally once daily for 16 weeks.
16276060|NCT00819585|Drug|Allopurinol|100-300 mg orally once daily for 24 weeks.
16276061|NCT00819585|Drug|Placebo Matching Canakinumab|Subcutaneous injection.
16276062|NCT00819585|Drug|Placebo Matching Colchicine|Capsule orally once daily for 16 weeks.
16276063|NCT00819572|Biological|DLX105, a single-chain (scFv) antibody fragment against TNF-alpha|Comparison of two different doses of intra-articular DLX105
16276064|NCT00819572|Drug|Placebo|
16276065|NCT00819559|Radiation|PCRT|Preoperative chemoradiotherapy
16276066|NCT00819546|Drug|RAD001|Participants will receive RAD001 on day 1 at the dose specified then again on days 8-28 for the first cycle. For all subsequent cycles RAD001 will be taken once daily.
16276067|NCT00819546|Drug|PKC412|50mg orally twice a day on days 2-28 for the first cycle. For all subsequent cycles 50mg of PKC412 will be taken orally twice daily.
16276068|NCT00819533|Device|sensor (ActiSight™ Needle Guidance System)|Patients will have their lung sample obtained under CT and ActiSight needle guidance system
16276069|NCT00819520|Drug|ivermectin|Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion
16276070|NCT00819520|Drug|malathion|Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
16276071|NCT00819507|Drug|Fluocinonide|Fluocinonide 0.1% cream topical daily for two weeks
16276072|NCT00819494|Procedure|Skin tests with radiocontrast media|Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media
16276073|NCT00819481|Device|3DKnee™ System|Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
16276074|NCT00819468|Drug|Teduglutide|Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.
16276075|NCT00819455|Behavioral|Experimental|Active Life style modification-motivation by I.T technology
16276076|NCT00819455|Behavioral|Control arm (usual care/standard care arm)|Life style modification only once
16276077|NCT00819442|Procedure|cardiobiopsy|5 samples will be taken from right ventricle by Cordis bioptome
16276078|NCT00819429|Dietary Supplement|Omega-3|1000mg of Omega-3 supplement will be given twice a day for a duration of 6 months. All supplements (including placebo) will be administered as two 500mg softgels twice daily, to be taken during breakfast and during the evening meal.
16276079|NCT00819429|Behavioral|Social Skills Training|1 hourly sessions over 12 weeks duration and 4 booster sessions at 3 weeks intervals. During these 16 sessions, children are taught empathy, pro-social skills, and a variety of positive coping techniques for problem-solving, emotional regulation, conflict resolution, and anger management via the use of practical strategies, materials, activities, role-play and games.
16276080|NCT00819429|Other|Standard Treatment (or TAU in Child Guidance Clinic)|Standard treatment is administered on a monthly basis to the parents of the child participants by the clinicians. Parents will be provided Parent Management Training where they will be taught behaviour and parenting techniques and may be referred to a parent support group. There is clinical pathway for the management of ADHD in our department which will be adhered to (i.e., Clinical Pathway for ADHD).
16276081|NCT00819416|Drug|5% albumin|5% albumin for the first 7 days of care in the ICU
16276082|NCT00819416|Drug|Normal Saline|Normal Saline for the first 7 days of care in the ICU
16276083|NCT00819403|Drug|simvastatin|Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
16276084|NCT00819403|Drug|ezetimibe/simvastatin|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
16276085|NCT00819390|Drug|Chloroquine|Taken orally, once daily, at a dose of 250 mg for 12 weeks.
16276086|NCT00819390|Drug|Placebo|Taken orally, once daily for 12 weeks.
16276087|NCT00819377|Drug|Milrinone|inhaled milrinone 5 mg (as for the injectable solution)
16276088|NCT00819377|Drug|Normal saline|5 ml normal saline by inhalation over 15 min
16276089|NCT00819364|Behavioral|BCRI intervention program|"Phase 1: The parents will receive a two-day lecture about autism to get the basic knowledge about autism intervention.
~Phase 2: BCRI model intervention.Parents and children will take part in a 24-halfday workshop to learn practical teaching skills in BCRI model. Then Home-based intervention using BCRI model for 11 months. At least 28 hours of BCRI intervention per week is acquired. Doctors or therapists will meet the parents and children once per month, each for 30 minutes, totally 10 times, to monitor and give advice on the interventions."
16276140|NCT00819013|Biological|Influenza A Vaccine: ACAM FLU-A|0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
16276090|NCT00819364|Behavioral|Standard community care|"Phase 1: the parents will receive a two-day lecture about autism to get the basic knowledge about autism intervention.
~Phase 2:Any treatment and interventions available chosen by families for children with autism and ASD, for at least one and a half years.
~Phase 3:One and a half years after enrollment, parents and children will be free to take part in the BCRI model intervention which is the same as Phase 2 for experimental group lasting for one year."
16276091|NCT00819351|Drug|PEG Asparaginase at six weeks interval|PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
16276092|NCT00819351|Drug|PEG Asparaginase at two weeks interval|PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
16276093|NCT00819338|Dietary Supplement|Efamax|5g daily as capsules for 3 months
16276094|NCT00819325|Drug|pioglitazone|pioglitazone 30mg p.o. once a day for 6 months
16276095|NCT00819325|Drug|oral hypoglycemic agents|sulfonylurea or metformin
16276096|NCT00819312|Drug|YAZ (SH T00186, BAY86-5300)|20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
16276097|NCT00819299|Device|AcuFocus Corneal Inlay ACI 7000PDT|corneal inlay
16276098|NCT00819286|Device|SternaLock Rigid Fixation Plates|patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
16276099|NCT00819286|Device|wire (control)|patients will have their sternum closed using wire (stainless steel surgical wire).
16276100|NCT00819260|Device|Harmonic Scalpel|harmonic scalpel used to reduce breast on this side
16276101|NCT00819260|Device|Electrocautery|Electrocautery used to reduce breast on this side
16276102|NCT00819247|Drug|Degarelix|Given as a subcutaneous injection.
16276103|NCT00819234|Drug|Placebo|placebo pramlintide and placebo metreleptin twice daily
16276104|NCT00819234|Drug|Pramlintide and Metreleptin|Subcutaneous injection, twice daily
16276105|NCT00819221|Drug|AZD2281|capsules, oral, bd, 2 months
16276106|NCT00819221|Drug|liposomal doxorubicin|once every 4 weeks at 40mg/m2
16276107|NCT00819208|Behavioral|exercise intervention|3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
16276108|NCT00819208|Other|counseling intervention|Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
16276109|NCT00819208|Other|educational intervention|Once at the beginning of the program
16276110|NCT00819208|Other|laboratory biomarker analysis|Every 12 months
16276111|NCT00819208|Other|questionnaire administration|Every 6 months
16276112|NCT00819208|Other|study of socioeconomic and demographic variables|Every 6 months
16276113|NCT00819208|Procedure|fatigue assessment and management|Every 6 months
16276114|NCT00819208|Procedure|quality-of-life assessment|Every 6 months
16276115|NCT00819208|Other|Educational Intervention|For Arm 2 just once at beginning of program.
16276116|NCT00819208|Other|Fitness testing|Objective fitness testing for both arms
16276117|NCT00819195|Drug|Glatiramer acetate|20 mg daily subcutaneous injection. Six-month duration.
16276118|NCT00819182|Behavioral|Paced respiration|Breathing exercise
16276119|NCT00819182|Behavioral|Sham comparator: fast shallow breathing|sham breathing exercise
16276120|NCT00819169|Biological|AMG 479|AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
16276121|NCT00819169|Biological|AMG 655|AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
16276122|NCT00819156|Drug|degarelix|Degarelix was given as subcutaneous injections.
16276123|NCT00819117|Device|Cardiac Resynchronization Therapy implant|Device implant with appropriate leads
16276124|NCT00819104|Drug|Metoprolol XL 50mg + Amlodipine 5mg|tablet,oral,OD,8 weeks
16276125|NCT00819104|Drug|Metoprolol XL 25 mg + Amlodipine 2.5mg|tablet,oral,OD,8 weeks
16276126|NCT00819104|Drug|Metoprolol XL 50mg|tablet,oral,OD,8 weeks
16276127|NCT00819104|Drug|Metoprolol XL 25 mg|tablet,oral,OD,8 weeks
16276128|NCT00819104|Drug|Amlodipine 5mg|tablet,oral,OD,8 weeks
16276129|NCT00819091|Drug|BI 1356|5mg orally (po) tablet qd
16276130|NCT00819091|Drug|Placebo|Placebo matching BI 1356 5mg one tablet daily
16276131|NCT00819078|Drug|Bupropion|300 mg/d
16276132|NCT00819078|Drug|Placebo|no dosage
16276133|NCT00819065|Drug|Botulinum toxin type A from laboratory Lanzhou|Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model. Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use. Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment). Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
16276134|NCT00819065|Drug|Botulinum toxin type A from laboratory Allergan|Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model. Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use. Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment). Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
16276135|NCT00819052|Drug|Nevirapine XR|Nevirapine XR
16276136|NCT00819052|Drug|Nevirapine XR|Nevirapine extended release
16276141|NCT00819013|Biological|Influenza A Vaccine: ACAM FLU-A|0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
16276142|NCT00819013|Biological|Influenza A Vaccine: ACAM FLU-A|0.5 mL ACAM FLU-A low dose, Intramuscular
16276143|NCT00819013|Biological|Saline placebo|0.5 mL, Intramuscular
16276144|NCT00819000|Drug|Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b|MS therapies (listed above) used according to prescribers' instructions.
16276145|NCT00818987|Other|Open reduction internal fixation; reduction and immobilization|
16276146|NCT00818961|Biological|alemtuzumab|43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9)
16276147|NCT00818961|Biological|graft-versus-tumor induction therapy|curative potential of allogeneic transplant results from the immune anti-tumor effect of donor cells or GVT/GVL
16276148|NCT00818961|Biological|rituximab|in patients with Cd20+ malignancies: rituximab 375 mg/m*2 day -13. rituximab 1000 mg/m*2 on days, -6, +1, +8.
16276149|NCT00818961|Drug|busulfan|For patients with AML, CML, MDS, MPS and ALL only: IV or oral busulfan may be given IV busulfan: 130 mg/m2 over 3 hours once daily on days -6, -5, -4 and -3 Oral busulfan: taken every 6 hours x 15 doses beginning on day -7 at 6pm and continuing through day -3 at 6am. 1 mg/kg test dose will be given prior to day -7 and PK samples will be drawn to calculate AUC.
16276150|NCT00818961|Drug|cyclophosphamide|750 mg/m2 infused over 1 hour once daily on days -5, -4 and -3. Cyclophosphamide will be started approximately 4 hours after the start of Fludarabine
16276151|NCT00818961|Drug|fludarabine phosphate|For patients with CLL, NHL & HD: 30 mg/m2 infused over 30 minutes once daily on days -5, -4 and -3 For patients with AML, CML, MDS, MPS and ALL: 40 mg/m2 infused over 30 minutes once daily on days -6, -5, -4 and -3.
16276152|NCT00818961|Drug|methotrexate|5 mg/m2 administered on days +1, +3 and +6
16276153|NCT00818961|Drug|tacrolimus|0.03mg/kg/day infused over 24 hours starting on day -1 and switched to oral (twice daily divided dose) on day 14 or when able to tolerate PO
16276154|NCT00818961|Procedure|allogeneic bone marrow transplantation|Recipients will receive an allogeneic transplant on day 0 after receiving high-dose chemotherapy. This trial uses matched unrelated donor stem cells.
16276155|NCT00818948|Drug|AMG 811|Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks beginning with day 1 (D1) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period.
16276156|NCT00818935|Dietary Supplement|Low-Intermediate-Glycemic Index diets|
16276157|NCT00818935|Dietary Supplement|High GI diet|
16276158|NCT00818909|Other|Systane|Systane prescription
16276159|NCT00818883|Drug|Azilsartan medoxomil and chlorthalidone|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
16276160|NCT00818883|Drug|Azilsartan medoxomil and hydrochlorothiazide|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
16276161|NCT00818870|Drug|Omeprazole|20 mg capsule, orally, once daily (before breakfast) for 5 days.
16276162|NCT00818870|Drug|Vecam|1 capsule, orally, once daily at bedtime for 5 days.
16276163|NCT00818870|Drug|Vecam|1 capsule, orally, once daily at bedtime for 5 days.
16276164|NCT00818857|Behavioral|Early Intervention|At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.
16276165|NCT00818857|Behavioral|Delayed intervention|One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.
16276166|NCT00818844|Drug|Nepafenac 0.1%|NSAID
16276167|NCT00818844|Other|BSS|BSS
16276168|NCT00818831|Drug|QBI-139|QBI-139 is being administered once a week over a two hour infusion in escalating doses.
16276169|NCT00818818|Drug|Meglumine antimoniate|5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
16276170|NCT00818805|Drug|Olopatadine 0.1%|one drop in one eye
16276171|NCT00818805|Drug|Tranilast 0.5%|one drop in one eye
16276172|NCT00818805|Drug|Placebo (Olopatadine)|one drop in contralateral eye
16276173|NCT00818805|Drug|Placebo (Tranilast)|one drop in contralateral eye
16276174|NCT00818792|Device|Coronary stent|Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
16276175|NCT00818779|Drug|Aliskiren|150 - 300 mg once daily for 6 weeks
16276176|NCT00818779|Drug|Amlodipine|5-10 mg once daily for 6 weeks
16276177|NCT00818766|Drug|cefazolin or vancomycin|Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
16276178|NCT00818766|Drug|Placebo|Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
16276179|NCT00818753|Drug|dabigatran 110 mg|comparison of different dabigatran dosages with unfractionated heparin
16276180|NCT00818753|Drug|dabigatran 150 mg|comparison of different dabigatran dosages with unfractionated heparin
16276181|NCT00818753|Drug|unfractionated heparin|comparison of different dosages dabigatran with unfractionated heparin
16276182|NCT00818740|Drug|ORM-12741|i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
16276317|NCT00817687|Drug|mycophenolate mofetil [CellCept]|As prescribed; + early biopsy
16276318|NCT00817687|Drug|mycophenolate mofetil [CellCept]|As prescribed; + standard treatment
16276319|NCT00817661|Dietary Supplement|Vitamin A|10000 IU Vitamin A or placebo per week
16276183|NCT00818714|Radiation|SBRT|"SBRT x 3 (start 6-9 weeks following standard ChemoRT; Time between SBRT Boost treatments: 40 hours to 8 days)
~Dose Escalation Schema:
~Cohort -3: 4 Gy x3 Cohort -2: 5 Gy x3 Cohort -1: 6 Gy x3 If de-escalation is required after initial cohort
~Cohort 1: 7 Gy x 3 INITIAL COHORT Cohort 2: 8 Gy x 3 Cohort 3: 9 Gy x 3
~Continue +1 Gy x 3 until reach MTD"
16276184|NCT00818701|Drug|low dose Nesiritide|Nesiritide infusion 0.005ug/kg/min
16276185|NCT00818701|Drug|nesiritide, Sildenafil|Nesiritide 0.005ug/kg/min Sildenafil 50 mg
16276186|NCT00818688|Procedure|compression ultrasonography at 3 months|A three-month follow-up prospective study was performed in the subgroup of patients with symptomatic ST but without deep-vein thrombosis on compression ultrasonography or documented symptomatic pulmonary embolism at inclusion, a group defined as patients with 'isolated ST'.
16276187|NCT00818675|Drug|Lead-In Ridaforolimus|Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.
16276188|NCT00818675|Drug|Comparator: Blinded Ridaforolimus|Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday
16276189|NCT00818675|Drug|Comparator: Blinded Placebo|Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday
16276190|NCT00818662|Biological|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg|400 mg/kg bodyweight every 2 weeks for 70 weeks
16276191|NCT00818662|Biological|Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg|200 mg/kg bodyweight every 2 weeks for 70 weeks
16276192|NCT00818662|Biological|Placebo solution: Human Albumin 0.25% - 4 mL/kg|Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
16276193|NCT00818662|Biological|Placebo solution: Human Albumin 0.25% - 2 mL/kg|Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
16276194|NCT00818649|Drug|bortezomib|1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle
16276195|NCT00818649|Drug|vorinostat|400 mg orally (po) every day on days 1-14 of a 21 day cycle
16276196|NCT00818636|Behavioral|Expressive writing (in addition to group therapy as usual).|Participants in the expressive writing condition write about their feelings about an issue of their choosing three times, for at least 20 minutes each time, during a two week period.
16276197|NCT00818623|Drug|Degarelix|Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
16276198|NCT00818623|Drug|Degarelix|Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
16276199|NCT00818623|Drug|Degarelix|Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
16276200|NCT00818623|Drug|Degarelix|Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
16276201|NCT00818623|Drug|Degarelix|Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
16276202|NCT00818623|Drug|Degarelix|Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
16276203|NCT00818623|Drug|Degarelix|Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
16276204|NCT00818623|Drug|Degarelix|Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
16276205|NCT00818610|Drug|Beta lactam (amoxicillin / clav. acid OR cefuroxime)|1.2 g 4x/d OR 1.5 g 3x/d IV
16276206|NCT00818610|Drug|Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)|1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO
16276207|NCT00818597|Device|EISS|Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.
16276208|NCT00818584|Drug|Micafungin|IV Administration
16276209|NCT00818571|Drug|Vildagliptin|Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
16276210|NCT00818571|Drug|Vildagliptin|Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
16276211|NCT00818571|Drug|Vildagliptin|Matching healthy volunteers receiving 25 mg vildagliptin once daily.
16276212|NCT00818571|Drug|Vildagliptin|Matching healthy volunteers receiving 50 mg vildagliptin once daily
16276213|NCT00818558|Biological|ISET Methode|Sampling of blood - ISET Methode
16276214|NCT00818545|Drug|ER4017 (hydroxypropyltetrahydropyrantriol)|Cream, 10%, each day during 3 months
16276215|NCT00818545|Drug|placebo|
16276216|NCT00818519|Drug|EE20/Drospirenone (YAZ, BAY86-5300)|20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
16276217|NCT00818519|Drug|Placebo|Inert tablet
16276218|NCT00818493|Drug|Q8003 (morphine sulfate and oxycodone hydrochloride)|IR Capsules, ascending flexible dose, every 4 to 6 hours
16276219|NCT00818493|Drug|Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)|One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours
16276220|NCT00818493|Drug|Percocet (oxycodone and acetaminophen)|One or two 5mg/325 mg tablets every 4 to 6 hours
16276221|NCT00818480|Drug|YM155|continuous infusion
16276222|NCT00818467|Other|Tanning spray|using 3% DHA twice a week for the 1st week and then once a week for 4 weeks and receiving 40mJ UV-B phototherapy three times a week for four weeks
16276223|NCT00818467|Other|UVB|receiving 40mJ UV-B phototherapy three times a week for four weeks
16276224|NCT00818454|Drug|Combivent CFC MDI|
16276225|NCT00818454|Drug|Albuterol HFA MDI|
16276226|NCT00818454|Drug|Respimat Combivent|
16276227|NCT00818441|Drug|Dacomitinib (PF-00299804)|Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
16276228|NCT00818441|Drug|Dacomitinib (PF-00299804)|In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
16276229|NCT00818428|Behavioral|Speech Production Intervention|Individual speech therapy directed at teaching the child to articulation specific speech sounds or word shapes accurately using traditional procedures such as phonetic placement and imitated and spontaneous speech production practice with feedback from the clinician about accuracy of articulatory gestures and knowledge of results.
16276320|NCT00817661|Dietary Supplement|Placebo|10000 IU Vitamin A or placebo per week
16276406|NCT00816972|Drug|Placebo for Oxybutynin 2.5 mg|Placebo BID
16276591|NCT00815542|Device|double balloon catheter|cervical ripening using double balloon catheter
16276230|NCT00818428|Behavioral|Speech Perception Intervention|Individualized intervention in which the Speech Assessment and Interactive Learning System is used to teach the child to identify recordings of words as either correct or incorrect pronunciations of the target word. In the event that the child is completely unable to pronounce the target speech sounds or word shapes focused stimulation activities are used to provide the child with further auditory exposure to the target forms. If the child stimulable for the target forms, the child is given opportunities the produce the target speech sounds or word shapes in the context of minimal pair games in which the child receives feedback about the communicative effectiveness of his or her attempts to produce the target words.
16276231|NCT00818428|Behavioral|Articulation Parent Group|Parents are taught to carry out home practice activities that focus on the child's ability to correctly articulate target speech sounds and word shapes.
16276232|NCT00818428|Behavioral|Dialogic Reading Parent Group|Parents are taught to read to their children using interactive techniques that help their children acquire new vocabulary, verbal reasoning abilities, and preliteracy skills.
16276233|NCT00818415|Drug|Naproxen sodium ER (BAYH6689)|Extented release Naproxen sodium (660mg) administered once a day
16276234|NCT00818415|Drug|Commercial Naproxen (Aleve, BAYH6689)|Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily
16276235|NCT00818389|Drug|Lithium Carbonate|Participants will receive capsules that contain 150 milligrams (mg) lithium carbonate. Participants will be randomized to lithium/riluzole or placebo/riluzole and treated for 52 weeks. Participants originally randomized to placebo who fail (progress) will crossover to lithium for the remainder of the trial.
16276236|NCT00818389|Drug|Riluzole|All participants enrolled in this study will be taking a stable dose of riluzole 50 milligrams (mg) by mouth (PO) twice per day (BID) for at least 30 days prior to screening.
16276237|NCT00818389|Drug|placebo|an inactive substance
16276238|NCT00818376|Other|Dental prophylaxis|Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
16276239|NCT00818363|Drug|SABER-Bupivacaine|Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
16276240|NCT00818363|Drug|SABER-Placebo|Injectable Solution; 5.0 mL SABER-Placebo/Once
16276241|NCT00818350|Drug|SUNITINIB|50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING
16276242|NCT00818337|Drug|Aspirin|Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily
16276243|NCT00818324|Drug|OPC-12759 Ophthalmic suspension|Instillation,4times/day,for 52weeks
16276244|NCT00818311|Device|LED GentleWaves®|primary spectral radiance with a dominant 590 nm wavelength (yellow visible light), irradiance power level of 4mW/cm2, Light pulsed with sequential period on/off for a total duration of 35 seconds per cycle.
16276245|NCT00818298|Drug|ziprazidone|Up to and including the time of the third PET scan, subjects will be titrated to 60 mg BID of ziprazidone. Thereafter they will receive 20-80 mg BID of ziprazidone, according to clinical effectiveness and side effects.
16276246|NCT00818285|Device|CDS for psychotropic drug management|Computerized decision support (CDS) for patients with available supplies of psychotropic medications. The decision support will consist of a screen displaying to the physician the patient's current risk of falling as well as what their risk could be lowered to with modifications to medications.
16276247|NCT00818272|Biological|Remicade (infliximab)|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of infliximab therapy with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
16276248|NCT00818259|Drug|Experimental: aprepitant|aprepitant powder for suspension, 125 mg/sachet, PO
16276249|NCT00818259|Drug|Experimental: fosaprepitant|fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV
16276250|NCT00818259|Drug|Comparator: ondansetron|ondansetron solution for infusion, IV, administered per local standard of care
16276251|NCT00818259|Drug|Ondansetron|ondansetron solution for infusion, IV, administered per local standard of care
16276252|NCT00818259|Drug|Dexamethasone|dexamethasone solution for infusion, IV, administered per local standard of care
16276253|NCT00818246|Device|Sham light|
16276254|NCT00818246|Device|LumiPhase-R™, OPUSMED Inc. Montreal, Canada|660 nm wavelength delivered in a sequential pulsing mode
16276255|NCT00818233|Device|Dynamic contour tonometry|Observe variability of measurements by dynamic contour tonometry
16276256|NCT00818220|Procedure|delayed umbilical cord clamping|at birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times.
16276257|NCT00818220|Other|Immediate cord clamping|The umbilical cord is cut within 10 seconds after birth
16276258|NCT00818207|Other|Full Smoking Cessation Treatment Coverage (100%)|This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.
16276259|NCT00818207|Other|No Smoking Cessation Treatment Coverage (0%)|None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.
16276260|NCT00818194|Drug|extended release tacrolimus|oral
16276261|NCT00818194|Drug|cyclosporine A microemulsion|oral
16276262|NCT00818181|Drug|Biological: AL0206st|
16276263|NCT00818168|Biological|Infliximab|"Dosage and infusion intervals were employed in
~accordance to the Summary of Product Characteristics (SmPC)"
16276264|NCT00818155|Drug|desvenlafaxine succinate SR|desvenlafaxine succinate SR
16276265|NCT00818155|Other|Placebo|
16276442|NCT00816647|Procedure|Patellofemoral stabilizing surgery|Comparison of surgical techniques
16276266|NCT00818142|Behavioral|ED/DM Support Group|The ED/DM Recovery Group focuses on assisting individuals with diabetes and an eating disorder - specifically the struggle of withholding insulin. The group utilizes strategies and tools that have been taught in other EDI programs, and also builds on the strengths of a group. The group is a means for learning and support as the individuals continue a regular schedule of school, work, and/or family life.
16276267|NCT00818129|Drug|AZD7295|ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution
16276268|NCT00818129|Drug|Placebo|multiple ascending dose (tbd based on single dose results), oral solution
16276269|NCT00818116|Device|AcrySof ReSTOR Aspheric IOL|Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.
16276270|NCT00818103|Drug|atorvastatin|Atorvastatin 40mg p.o. qn for 2 years
16276271|NCT00818103|Drug|β-interferon|β-interferon 50ug i.m. qod for 2 years
16276272|NCT00818103|Drug|EPO|EPO 10000U i.h. bid for 5 days
16276273|NCT00818090|Drug|paclitaxel and cisplatin|paclitaxel and cisplatin every 3 weeks
16276274|NCT00818077|Other|Continuous Glucose Monitoring of Carbohydrate Intake|Subjects eat standard breakfast and lunch and keep food records.
16276275|NCT00818064|Drug|anti-IL-20|Single s.c. injection (per dose cohort)
16276276|NCT00818064|Drug|placebo|Single s.c. injection (per dose cohort)
16276277|NCT00818051|Radiation|intensity-modulated radiation therapy|Given as 48, 53, or 56 Gy
16276278|NCT00818038|Drug|BG0002 (natalizumab)|Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.
16276279|NCT00818025|Behavioral|Pocket PATH (Personal Assistant for Tracking Health)|Participants in the intervention group will be trained to use a hand-held device with custom programs as a means of supporting, tracking, and interpreting discharge activities in addition to the standard paper-tracking methods.
16276280|NCT00817999|Dietary Supplement|Grapefruit juice|Participants received grapefruit juice during 1 of the 2 periods.
16276281|NCT00817999|Drug|Clopidogrel 75 mg/day|
16276282|NCT00817999|Drug|Clopidogrel 300 mg|
16276283|NCT00817986|Drug|Arbaclofen placarbil, 20 mg|tablets
16276284|NCT00817986|Drug|Placebo|tablets
16276285|NCT00817986|Drug|Arbaclofen placarbil, 30 mg|tablets
16276286|NCT00817986|Drug|Arbaclofen placarbil, 40 mg|tablets
16276287|NCT00817973|Dietary Supplement|Casein|
16276288|NCT00817973|Dietary Supplement|Whey|
16276289|NCT00817973|Dietary Supplement|Cod|
16276290|NCT00817973|Dietary Supplement|Gluten|
16276291|NCT00817960|Drug|Methylphenidate|The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design
16276292|NCT00817947|Device|High frequency chest wall oscillation|Airway clearance using high frequency chest wall oscillation ('The Vest')
16276293|NCT00817934|Drug|AB PREP|Potassium phosphate and Sodium Phosphate,(in the form of K-phos neutral 8 tablets.(Bisacodyl)6tablets. The third medication is (Metoclopramide).
16276294|NCT00817895|Drug|sustained released 5-FU and sustained released cisplatin|600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.
16276295|NCT00817895|Drug|sustained released 5-FU|600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.
16276296|NCT00817895|Procedure|TACE|All patients will accept TACE one month after tumor was resected.
16276297|NCT00817882|Other|individually targeted vocational rehabilitation|"individually targeted vocational rehabilitation over 4 month period, maximum of 10 sessions, in addition to routine back pain rehabilitation.
~Maximum of 25 participants with low back pain"
16276298|NCT00817882|Other|routine back pain rehabilitation|routine back pain rehabilitation Maximum of 25 patients with low back pain
16276299|NCT00817869|Other|New flooring|8.3mm thick vinyl floor covering with foam backing, manufactured by Tarkett and installed by Tyndale Flooring Ltd.
16276300|NCT00817843|Drug|Simvastatin|6 weeks of treatment with simvastatin 80 mg
16276301|NCT00817843|Drug|Simvastatin/Ezetimibe|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
16276302|NCT00817830|Drug|lodenafil carbonate|Patients will do a cardiopulmonary exercise test after placebo administration. Seven days later, a new cardiopulmonary test should be done using lodenafil carbonate, 80mg, orally.
16276303|NCT00817817|Device|MF|One evening dose of dry powder inhaled MF 400 μg (Multidose device).
16276304|NCT00817817|Device|MF|One evening dose of dry powder inhaled 400 μg (400 μg capsules - Monodose).
16276305|NCT00817804|Device|Use of the V60 Mask Ventilator|The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
16276306|NCT00817791|Device|Hyperbaric oxygen pretreatment (GR2200)|2 hours/day,5 days before surgery
16276307|NCT00817778|Drug|AZD1656|Subjects will be treated with tolerable dose twice daily for another 24 days.
16276308|NCT00817778|Drug|Placebo|Subjects will be treated with tolerable dose twice daily for another 24 days.
16276309|NCT00817765|Drug|Posaconazole|Posaconazole oral solution 40mg/mL; 400mg BID treatment for 10 days, including dose escalation
16276310|NCT00817765|Drug|Fosamprenavir|fosamprenavir tablet 700mg; 1 tablet BID for 10 days
16276311|NCT00817765|Drug|Ritonavir|Ritonavir 100mg capsule; 1 capsule BID for 10 days
16276312|NCT00817752|Dietary Supplement|Ashwagandha|Participants consume 3mL of Ashwagandha for 5 days. Blood work/immune cells (CD4 T-cells, CD8 T-cells, B-cells, NK cells, macrophages, IL-1, IL-6 and TNF-alpha) and psychological assessments (POMS and STAI Self-Evaluation) given at specified time intervals.
16276313|NCT00817739|Drug|Leuprorelin|Leuprorelin injection
16276314|NCT00817739|Drug|Flutamide|Flutamide tablets
16276315|NCT00817713|Drug|Praziquantel, Ivermectin, Albendazole|"Standard HIV care plus triple anthelminthic treatment
~Praziquantel 2400mg single dose
~Ivermectin 12 mg, single dose
~Albendazole 400mg, 2 doses in 1 day
~All drugs given at baseline, after 6 months and after 12 months."
16276316|NCT00817700|Other|Sleep restriction|Sleep restriction.
16276321|NCT00817648|Drug|Quetiapine|Quetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
16276322|NCT00817648|Drug|risperidone|risperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.
16276323|NCT00817635|Drug|LCI699|LCI699 oral capsules
16276324|NCT00817635|Drug|Eplerenone|Eplerenone oral capsules
16276325|NCT00817635|Drug|LCI699-matching Placebo|LCI699-matching placebo oral capsules
16276326|NCT00817635|Drug|Eplerenone-matching Placebo|Eplerenone-matching placebo oral capsules
16276327|NCT00817622|Dietary Supplement|EPA, Vitamin E|EPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks
16276328|NCT00817609|Drug|Angongniuhuang Pill|7 days of Angongniuhuang Pill
16276329|NCT00817609|Drug|placebo|7 days of placebo
16276330|NCT00817596|Device|Infusion Pump (Prometra)|Implantation of pump/catheter for infusion of morphine into the intrathecal space
16276331|NCT00817583|Drug|docetaxel, cisplatin, fluorouracil|"neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
~concurrent chemotherapy:cisplatin 40 mg/m2 weekly"
16276332|NCT00817583|Radiation|3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)|
16276333|NCT00817557|Drug|Loteprednol|Anti-inflammatory
16276334|NCT00817557|Other|Rewetter|
16276335|NCT00817544|Drug|ORM-12741|3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741
16276336|NCT00817531|Drug|Dasatinib|pill form, 100 mg daily
16276337|NCT00817518|Drug|RO4987655|Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2)
16276338|NCT00817518|Drug|RO4987655|Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2)
16276339|NCT00817505|Drug|AZD1656|Single dose oral tablet
16276340|NCT00817505|Drug|AZD1656|Single dose oral suspension
16276341|NCT00817479|Drug|Dexamethasone|20 MG OF DEXAMETHASONE OR PLACEBO
16276342|NCT00817479|Drug|Placebo|Placebo saline
16276343|NCT00817466|Drug|Racemic adrenaline|"For inhalation.
~Dosing (as in previous study):
~1) 0,1ml<5kg, 0,15ml 5-6,9kg, 0,20ml 7-9,9kg, 0,25ml >10kg of racemic adrenaline 20mg/ml diluted in 2ml NaCl 9mg/ml.3
~Maximum 12 inhalations/24 hours. One bottle (10ml) per patient. The bottles will be marked with the name of the study and a randomisation number."
16276344|NCT00817466|Drug|Isotonic saline|2ml NaCl 9mg/ml.
16276345|NCT00817440|Other|Exercise|1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.
16276346|NCT00817440|Other|Fasting|3 days of fasting and then the same as arm 1
16276347|NCT00817427|Other|Controls Short sleep|Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption
16276348|NCT00817427|Other|CKD- sleep extension|Sleep will be increased by 2 hours each night for 3 nights
16276349|NCT00817414|Drug|LCI699-matching placebo|LCI699-matching placebo oral capsules
16276350|NCT00817414|Drug|LCI699|LCI699 oral capsules
16276351|NCT00817401|Device|hypothermia|For the systemic hypothermia treatment (TS Med 200, Germany), the infants were nursed under an open unit, covered only by a diaper and a thin linen, loosing heat to the environment and to a cooling mat¬tress which was perfused by circulating liquid at a variable temperature. The rectal temperature was targeted at 33.5 °C (range of 33 to 34 °C) and was meant to be achieved within 60 min. The body temperature was checked every 10 min during induction hypothermia and every hour during the remaining period of cooling. The duration of hypothermia was 72 hrs. Rewarming was started by stopping the cooling system. The infant was meant to reach a 36.5°C rectal temperature in 6 hrs after stopping cooling to prevent rebound hyperthermia.
16276352|NCT00817388|Other|No intervention|No intervention
16276353|NCT00817375|Drug|SSRI treated group|Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
16276354|NCT00817375|Drug|non-SSRI treated group|Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
16276355|NCT00817362|Drug|IPI-504|IPI-504 IV infusion 300 mg/m2
16276356|NCT00817362|Drug|Trastuzumab|Trastuzumab IV infusion 8 mg/kg as the first dose of trastuzumab, followed by trastuzumab 6 mg/kg every 3 weeks. Subjects whose last dose of trastuzumab was <4 weeks prior to study entry will receive 6 mg/kg as the first dose of trastuzumab. For all additional cycles in Stage 1, trastuzumab will be administered with the first dose of IPI-504.
16276357|NCT00817336|Drug|D Serine|60 mg/kg/day
16276358|NCT00817336|Drug|Placebo|oral
16276359|NCT00817323|Procedure|Dietary amino-acid depletion|See detailed description
16276360|NCT00817297|Device|noninvasive ventilator|Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design
16276361|NCT00817284|Drug|bevacizumab and Irinotecan and radiotherapy|"Bevacizumab 10 mg/kg is administered on days 1 and 15.
~Irinotecan:
~Irinotecan 125 mg/m2 is administered on days 1 and 15 to patients NOT receiving enzyme-inducing antiepileptic drugs (EIAED).
~Irinotecan 340 mg/m2 is administered on days 1 and 15 to patients receiving EIAEDs.
~During concomitant chemoradiotherapy, bevacizumab and irinotecan are given in the same doses and schedules as before and after chemoradiotherapy.
~Radiotherapy is delivered during 3rd and 4th cycle of chemotherapy and consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday to Friday) over a period of six weeks for a total dose of 60 Gy."
16276401|NCT00816985|Procedure|Liposuction|Liposuction is a procedure that involves the removal of fat from deposits beneath the skin using a hollow stainless steel tube with the assistance of a powerful vacuum. Liposuction can be accomplished either with the use of local or general anesthesia.
16276402|NCT00816985|Other|Quality of Life Questionnaires|Ratings of 0 to 4, with 0 being Not at ll and 4 being Very Much, regarding how true each statement has been. Statements are in the following categories: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Additional Concerns.
16276403|NCT00816972|Drug|Desloratadine 2.5 mg|Desloratadine 2.5 mg BID
16276362|NCT00817284|Drug|Bevacizumab and Temozolomide and radiotherapy|"Bevacizumab 10 mg/kg is administered on days 1 and 15. Temozolomide dosing before start concomitant chemoradiotherapy: 150 mg/m2/day on days 1-5 during the first 28 days treatment cycle, then 200 mg/m2/day on the subsequent cycles until radiotherapy.
~Temozolomide administered concomitantly with the radiotherapy: Temozolomide 75 mg/m2/day for 7 days per week is administered on each day of radiotherapy.
~After completed chemoradiotherapy, temozolomide is dosed and administered as it was prior to start chemoradiotherapy, i.e. temozolomide 200 mg/m2/day on days 1-5 out of a 28 days schedule, taking into consideration any previous dose-reductions already made.
~Radiotherapy is delivered during 3rd and 4th cycle of chemotherapy and consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday to Friday) over a period of six weeks for a total dose of 60 Gy."
16276363|NCT00817271|Drug|AZD1656|Dose titration of oral suspension during 2 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose for another 6 days. On day 5 and 8 the dose will be given as a single dose
16276364|NCT00817271|Drug|Glucagon|1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8
16276365|NCT00817258|Drug|cisplatin|Cisplatin 40mg/m2,weekly
16276366|NCT00817258|Radiation|3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)|3D-CRT or IMRT
16276367|NCT00817245|Drug|omeprazole, Amoxicillin, metronidazole|we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR
16276368|NCT00817232|Device|Microcurrent (Elexoma Medic)|monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
16276369|NCT00817219|Drug|Calcipotriene plus betamethasone dipropionate ointment|Once daily application for 4 weeks
16276370|NCT00817206|Drug|LCP-Tacro|LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.
16276371|NCT00817206|Drug|Prograf|Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
16276372|NCT00817193|Behavioral|Physical Activity|Physical Activity program
16276373|NCT00817193|Behavioral|Wellness|Wellness program
16276374|NCT00817180|Other|Positive Expiratory Pressure (PEP)|Physiotherapy technique for airway clearance
16276375|NCT00817180|Other|High Frequency Chest Wall Oscillation (HFCWO) using InCourage Vest System|Physiotherapy technique for airway clearance.
16276376|NCT00817167|Device|inReach bronchoscopy planning software|inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.
16276377|NCT00817167|Device|Standard lung CT viewer|CT viewer, used for standard bronchoscopy
16276378|NCT00817154|Behavioral|HOPES-I|The program progresses in three steps. First, participants receive a 10-week Basic Skills for Community Living course covering essential skills from each of the five modules to ensure that all participants establish basic competency in a core set of skills. Second, clinicians assess participants' functioning to identify skill areas that warrant additional improvement and engage participants in a shared decision making process to select skill areas to pursue in greater depth. Third, clinicians have weekly 60 minute sessions with participants in community settings for 7 months to provide training and to facilitate and support acquisition of core skills and rehabilitation goals.
16276379|NCT00817141|Other|Observational study, no intervention|Observation of the complications seen without urinary catheter (which is the habitual protocol in our institution)
16276380|NCT00817128|Procedure|PEPT|Pain Exposure Physical Therapy
16276381|NCT00817128|Procedure|CBO standard|Standard therapy as defined in CBO guideline 2006
16276382|NCT00817115|Device|Region-of-Interest Imaging (X-ray Fovea Imaging)|Use of an experimental fluoroscopy system fitted with a region-of-interest attenuator (fovea) to evaluate or treat lesions during cardiac interventional procedures.
16276383|NCT00817102|Procedure|FFR, IVUS, VH, or combination of the three|Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures will be completed during the cardiac catheterization procedure.
16276384|NCT00817089|Drug|Placebo Oral Tablet|Placebo pill
16276385|NCT00817089|Drug|Naltrexone|50 mg of naltrexone prior to challenge session
16276386|NCT00817076|Drug|desloratadine|desloratadine syrup; 5.0 mL once daily for 28 days
16276387|NCT00817063|Drug|alitretinoin|Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
16276388|NCT00817063|Drug|Placebo|Patients receive matching placebo for up to 24 weeks
16276389|NCT00817050|Drug|Mometasone Furoate Nasal Spray|One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray
16276390|NCT00817050|Drug|fluticasone nasal spray|One dose (2 sprays in each nostril) of fluticasone nasal spray
16276391|NCT00817037|Drug|Sitaxsentan|Sitaxsentan 100mg once daily oral dosing for 6 weeks
16276392|NCT00817037|Drug|Nifedipine|Nifedipine 30mg once daily oral dosing for 6 weeks
16276393|NCT00817037|Drug|Placebo tablet|Placebo tablet once daily oral dosing for 6 weeks
16276394|NCT00817024|Drug|Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,|3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
16276395|NCT00817024|Drug|Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules|3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks
16276396|NCT00817024|Drug|Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules|3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
16276397|NCT00817011|Drug|SSRI treated group|Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
16276398|NCT00817011|Drug|non-SSRI treated group|Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
16276399|NCT00816998|Procedure|Physical therapy|Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
16276400|NCT00816998|Procedure|Physical Therapy|Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist
16276404|NCT00816972|Drug|Oxybutynin 2.5 mg|Oxybutynin 2.5 mg BID
16276405|NCT00816972|Drug|Placebo for Desloratadine 2.5 mg|Placebo BID
16276407|NCT00816959|Drug|R-mabHDI and ABVD|"The subjects will receive R-mabHDI intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. R-mabHDI will be given for 2 cycles.
~Also the subjects will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will be given for 6 cycles."
16276408|NCT00816959|Drug|ABVD|The subjects will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will be given for 6 cycles.
16276409|NCT00816946|Behavioral|Enhanced education|"Enhanced Nutritional education/counseling to mothers on the following topics:
~During Pregnancy: diet during pregnancy; antenatal care; iron tablets; colostrum Postpartum period: difficulties during lactation; diet during lactation; EBF; childhood vaccination; newborn care Complementary Feeding General Health: vitamin A; diarrhea management; iodine; hygiene for health; protection from malaria; ARI & protection against ARI"
16276410|NCT00816933|Procedure|appendectomy|appendectomy according to the number of trocar
16276411|NCT00816920|Other|Ultrasound examination of leg veins|Outpatients symptomatic for leg DVT follow the standard diagnostic procedure (ultrasound examination of proximal deep veins, pre-test clinical probability and D-dimer, and a second US after 5-7 days) to exclude proximal DVT; they also receive by another doctor a complete US examination of the deep leg veins to assess the presence of isolated calf DVT, the results of the latter examination are kept blind to the patient and to the treating doctor, and disclosed after three months
16276412|NCT00816907|Drug|Metformin|500 mg to 1,000 mg taken twice daily for 16 weeks
16276413|NCT00816907|Drug|Placebo|1 to 2 placebo capsules taken twice daily for 16 weeks
16276414|NCT00816894|Drug|D-serine|6 week fixed dose phase with D-serine 1500 mg/day to be increased starting from week two to 3000 mg/day followed by a 4 week flexible dose phase allowing for two 500 mg/day dose changes
16276415|NCT00816894|Drug|Olanzapine|6 week fixed dose phase with Olanzapine 15 mg/day to be increased starting from week two to 30 mg/day followed by a 4 week flexible dose phase allowing for two 5 mg/day dose changes.
16276416|NCT00816881|Device|flutter mucus clearance device|five minutes every session, four sessions per day
16276417|NCT00816868|Drug|erlotinib in combination with capecitabine|Erlotinib 150 mg Q.D. orally for 21 days plus Capecitabine 1000 mg/m2 twice daily for 2 weeks followed by 1 week break every 21 days Until PD, unacceptable toxicity or death.
16276418|NCT00816855|Drug|docetaxel, cisplatin, fluorouracil|"neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
~concurrent chemotherapy:cisplatin 40 mg/m2 weekly"
16276419|NCT00816829|Drug|Placebo|Fenofibrate-matching placebo tablet
16276420|NCT00816829|Drug|Fenofibrate|145 mg NanoCrystal tablet
16276421|NCT00816816|Drug|docetaxel, cisplatin, fluorouracil|"neoadjuvant chemotherapy: docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
~concurrent chemotherapy:cisplatin 40 mg/m2 weekly."
16276422|NCT00816803|Procedure|Autologous bone marrow transplant|
16276423|NCT00816803|Procedure|Physical therapy|
16276424|NCT00816790|Drug|Piperacillin/Tazobactam|eGFR 20-40 mls/min: Piperacillin/Tazobactam 3.375g IV q6h x 24 hours eGFR < 20 mls/min: Piperacillin/Tazobactam 2.25g IV q6h x 24 hours
16276425|NCT00816790|Drug|Piperacillin/Tazobactam|Piperacillin/Tazobactam 4.5g IV q 6h x 24 hours
16276426|NCT00816777|Procedure|Chemoembolization with irinotecan Bead|Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
16276427|NCT00816777|Drug|Irinotecan|Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
16276428|NCT00816764|Biological|AGS-8M4|IV Infusion
16276429|NCT00816751|Procedure|Paracervical block|The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
16276430|NCT00816751|Procedure|Intracervical|The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
16276431|NCT00816751|Drug|Buffered Lidocaine, vasopressin, sodium bicarbonate|The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
16276432|NCT00816725|Behavioral|Mothers and babies Internet course and PPD informational brochure|An eight-lesson, self-help, Web-based program for the prevention of postpartum depression based on cognitive behavioral therapy, social-learning, and attachment theory. The PPD informational brochure is a four-page pamphlet that contains information about postpartum depression.
16276433|NCT00816712|Drug|Comparator: Testosterone 300 mg, intramuscular injection|"Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
~Day 1 & 7 - Testosterone 300 mg, Intramuscular injection."
16276434|NCT00816712|Drug|Comparator: Testosterone 100 mg, Intramuscular injection|"Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
~Day 1 & 7 - Testosterone 100 mg, Intramuscular injection."
16276435|NCT00816712|Drug|Comparator: Placebo given by Intramuscular Injection|"Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
~Day 1 & 7 - Placebo given as intramuscular injection."
16276436|NCT00816699|Other|preprint preoperative anesthetic risk information|preprint preoperative anesthetic risk information
16276437|NCT00816686|Biological|AGS-16M18|IV Infusion
16276438|NCT00816673|Drug|placebo Circadin|Placebo tabs of Prolonged release melatonin
16276439|NCT00816673|Drug|Circadin|prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks
16276440|NCT00816660|Biological|Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII)|Single dose, dose escalation, various cohorts
16276441|NCT00816660|Biological|Marketed plasma-derived VWF/FVIII concentrate|Cross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate
16276443|NCT00816634|Drug|Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)|"3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma.
~Chemotherapy regimen (XP):
~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks
~Chemotherapy regimen (XT):
~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks"
16276444|NCT00816621|Behavioral|ABC for Children Adopted Internationally|Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the ability of children to regulate their attention, behavior, and physiology and to develop secure, organized attachments to their parents.
16276445|NCT00816621|Behavioral|DEF for Children Adopted Internationally|Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.
16276446|NCT00816595|Biological|bevacizumab|Given IV
16276447|NCT00816595|Biological|pegfilgrastim|Given subcutaneously
16276448|NCT00816595|Biological|rituximab|Given IV
16276449|NCT00816595|Drug|cyclophosphamide|Given IV
16276450|NCT00816595|Drug|pentostatin|Given IV
16276451|NCT00816582|Procedure|Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline|A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.
16276452|NCT00816582|Procedure|Diagnostic Imaging: 18F-FES PET/CT - Baseline|A 18F-FES PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to determine the hormone receptor content of the sites involved by the breast cancer.
16276453|NCT00816582|Procedure|Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up|A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.
16276454|NCT00816569|Device|Orthokeratology contact lenses|Wearing Orthokeratology lens in one eye of a keratoconus patient
16276455|NCT00816556|Drug|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.
16276456|NCT00816556|Drug|Estradiol valerate|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
16276457|NCT00816556|Drug|Vanicream Lite|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
16276458|NCT00816543|Drug|DOCETAXEL|50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
16276459|NCT00816543|Drug|S-1|80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
16276460|NCT00816543|Drug|OXALIPLATIN|100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
16276461|NCT00816530|Device|Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography|After density > 50% is confirmed by routine digital screening mammography, ABUS will be performed.
16276462|NCT00816517|Biological|injection of botulinum toxin type A.|35 to 100 units injected around a skin lesion (plaque) one time.
16276463|NCT00816504|Drug|Galactose|Oral galactose, 0.2 g/kg/dose twice daily for 28 days
16276464|NCT00816491|Device|conventional white light colonoscopy|conventional white light colonoscopy
16276465|NCT00816491|Device|FICE (Fujinon Intelligent Chromoendoscopy)|chromoendoscopy
16276466|NCT00816478|Drug|Galactose|Oral galactose, 0.2 g/kg/dose twice daily for 28 days
16276467|NCT00816465|Dietary Supplement|Hoodia gordonii|PO administration of 1 Tab Hoodia gordoni extract per day.
16276468|NCT00816465|Other|Placebo|PO Placebo pill
16276469|NCT00816426|Drug|Rifampicin|Rifampicin or rifampin (RIF) is a semi-synthetic compound derived from Amycolatopsis rifamycinica. It is mostly used in combination to treat TB, while other disease indications include brucellosis, leprosy, legionnaire's disease and problematic drug-resistant staphylococcal infections. RIF inhibits DNA-dependent RNA polymerase in bacterial cells by binding its beta-subunit, thus preventing transcription to RNA. Its MIC against replicating TB bacilli is 0.1 g/ml and its minimum bactericidal activity (MBC) is 0.5 g/mL. It is one of the rare anti-TB drugs with some activity against nonreplicating cells.
16276470|NCT00816426|Drug|Isoniazid|Isoniazid (INH) is a first-line antituberculous medication discovered in 1952 and used in the prevention (alone) and treatment (in combination) of tuberculosis. Isoniazid is a prodrug and must be activated by a bacterial catalase to inhibit the synthesis of mycolic acids in the mycobacterial cell wall. Consequently, INH is bactericidal to rapidly-dividing mycobacteria, with an MIC of 0.05 g/ml and an MBC of 1 g/ml, but is inactive if the mycobacterium is nonreplicating or slow-growing.
16276471|NCT00816426|Drug|Pyrazinamide|Pyrazinamide (PZA) is a synthetic derivative of nicotinamide requiring ctivation by the mycobacterial enzyme pyrazinamidase, only active under acidic conditions which are thought to be found within the phagolysosomal compartment of macrophages. The conversion product, pyrazinoic acid, inhibits fatty acid synthetase I, required by the bacterium to synthesize fatty acids, though this has been disputed. It has an MIC of 6 g/ml and is not cidal under in vitro conditions. Overall, its mechanism of action and reasons for good sterilizing activity in vivo are poorly understood. It is part of the 4-drug combination recommended by the WHO to treat drugsensitive tuberculosis and is also included in most econd-line regimens.
16276472|NCT00816426|Drug|Kanamycin|Kanamycin (KM) is an aminoglycoside antibiotic belonging to the same class of drugs as Streptomycin, one of the first drugs used to treat TB in the 50 s. It kills sensitive bacteria by binding to the 30S ribosomal subunit and interfering with protein synthesis. Its MIC and MBC against MTB are 2 and 6 g/mL, respectively, with a remarkably low MBC/MIC ratio. However, KM is only used to treat serious bacterial infections due to severe renal toxicity and ototoxicity. No interaction with the metabolism of other drugs has been reported. The drug is approved by the Korean Ministry of Food and Drug Safety (MFDS) but not the US FDA for use against pulmonary TB.
16276473|NCT00816426|Drug|Moxifloxacin|Moxifloxacin (MXF) is a synthetic fluoroquinolone antibiotic. It inhibits bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, which are essential enzymes playing a crucial role in the replication and repair of bacterial DNA. Its MIC, MBC and intracellular activity against MTB are 0.5, 2 and 1 g/mL, respectively, with again a low MBC/MIC ratio.
16276474|NCT00816413|Drug|cyclosporine|2 mg/kg IV over 2 hours every 12 hours starting at 0700 on days -1, 0, and +1 (total of six doses).
16276475|NCT00816413|Drug|mycophenolate mofetil|15 mg/kg orally twice a day starting day 0 until day +27 then stopped without tapering in the absence of aGVHD then tapered over two months in the absence of aGVHD. Doses will be rounded to the nearest 250 mg.
16276476|NCT00816413|Drug|pentostatin|4 mg/m2/d IV over 30 minutes daily x 3 days, (days -10, -9, -8)to begin ten days prior to stem cell infusion (Day 0).
16276477|NCT00816413|Genetic|cytogenetic analysis|At days +28 and +70 post-transplant, patients' blood will be evaluated for CD3 and overall WBC chimerism.
16276478|NCT00816413|Genetic|fluorescence in situ hybridization|Mixed chimerism is defined as the detection of 95% or less donor T cells (CD3+), expressed as a proportion of the total T cell and WBC population as measured by DNA.
16276479|NCT00816413|Genetic|protein analysis|Blood samples will be at baseline(day -11 or before) , days -8 and -1, prior to transplant on day 0, then weekly (days +7, +14, +21 and +28) post-transplant through day +28. Five ml's of blood will be drawn at each collection through a central line using heparinized vaccutainers. Samples will be spun down at 1200 g and plasma aspirated and stored in -80 oC until analyzed for the ELISA Assays being done for research purposes in this protocol.
16276480|NCT00816413|Other|flow cytometry|Peripheral blood Peripheral blood flow cytometry for immunophenotyping including Th/c1 and Th/c2 subsets, mitogens (PHA, PWM), NK and LAK function studies, DCs, apoptosis assay of tumor cells, and lymphocyte subsets (CD4, CD8, CD19, CD56
16276481|NCT00816413|Other|immunoenzyme technique|Peripheral blood for immunophenotyping including Th/c1 and Th/c2 subsets, mitogens (PHA, PWM), NK and LAK function studies, DCs, apoptosis assay of tumor cells, and lymphocyte subsets (CD4, CD8, CD19, CD56
16276482|NCT00816413|Other|laboratory biomarker analysis|Donor mononuclear cells from the stem cell product (SCP) obtained with apheresis will be analyzed for surface markers, including CD3, CD4, CD8, CD19, CD14, CD56, TCR+CD8+ cells, Th/c1 and Th/c2, Fas and FasL, and DCs, as well as for apoptosis
16276483|NCT00816413|Other|reduced-intensity transplant conditioning procedure|"Allopurinol 300 mg orally once daily x 10 days, to begin one day prior to treatment with Pentostatin (day -11 to day -2) .
~Pentostatin 4 mg/m2/d IV over 30 minutes daily x 3 days, (days -10, -9, -8)to begin ten days prior to stem cell infusion (Day 0) .
~Pre and Post Pentostatin Hydration: 1000ml Normal Saline IV over 2 hours pre each dose of Pentostatin and 1000ml Normal Saline IV over 4 hours post each dose of Pentostatin on days -10, -9, -8.
~Pre Pentostatin Recommended Antiemetics: Ondansetron 32 mg IV over 30 minutes to be given 30 min. before each dose of Pentostatin on days -10, -9, -8. Alternative ondansetron equivalent or other ancillary antiemetics may be used at the discretion of the treating physician.
~Pred Forte Eye Drops: two drops in each eye every 4 hours while awake x 7 days after starting Pentostatin (day -10 to day -4)."
16276484|NCT00816413|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Each patient will receive up to four IV infusions administered over 30 minutes of donor T cells at increasing cell doses given at intervals.
16276485|NCT00816413|Procedure|peripheral blood stem cell transplantation (PBSC)|PBSC are infused intravenously either by infusion or IV push on day 0 through a secure intravenous access (i.e. the double-lumen central catheter place pre transplant) according to institutional guidelines.
16276486|NCT00816413|Radiation|total-body irradiation|2.0 GY will be administered on day -1. Total-body irradiation (TBI) will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. It is anticipated that TBI will be given on day -1; however, the timing of TBI administration may be altered by factors beyond the control of the Principal Investigator because of the delivery of unrelated donor stem cells.
16276487|NCT00816400|Drug|MEDI-575|MEDI-575 as an IV infusion
16276488|NCT00816387|Procedure|Fallopian tube sperm perfusion|Patients are treated with fallopian tube sperm perfusion
16276489|NCT00816387|Procedure|Intrauterine insemination using standard catheter|Patients are treated with standard intrauterine insemination
16276490|NCT00816374|Other|Reading materials and discussions|"We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:
~The American Cancer Society
~The American Academy of Dermatology
~The Skin Cancer Foundation
~The pamphlets contain information about ways to reduce risk for skin cancer including:
~Sun protection practices
~Risk factors for melanoma
~Information about what melanoma looks like
~How to do skin self-examinations
~There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets."
16276491|NCT00816374|Other|Reading materials and discussions|"We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:
~Melanoma and skin cancer protection guidelines
~The benefits of skin screening practices
~Ways to protect yourself from the sun
~In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets."
16276492|NCT00816374|Other|Questionnaires|"Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:
~knowledge of melanoma
~current and past skin cancer screening practices
~current and past sun protection practices
~attitudes about skin cancer and sun protection
~feelings about relative's melanoma diagnosis and treatment"
16276493|NCT00816361|Drug|MEDI-573|Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.
16276494|NCT00816348|Drug|Omegaven|Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
16276495|NCT00816335|Procedure|PET/CT scan|For all patients undergoing a preoperative PET/CT scan on the day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained on a Siemens Biograph 16 PET/CT scanner (Siemens, Knoxville, TN).
16276585|NCT00815607|Drug|INXN-1001|Capsules given once daily for 14 days for 3 treatment cycles.
16276496|NCT00816335|Drug|18F-FDG Injection|Patients undergoing a preoperative PET/CT scan the day of surgery, are required to have fasted for at least 4 hours prior to the anticipated preoperative PET/CT scan. Patients participating in this pilot study (whether they have had their preoperative PET/CT scan prior to the day of surgery or whether they are having their preoperative PET/CT scan on the day of surgery) will receive a preoperative IV injection into a peripheral vein of 15 mCi of 18FFDG at time interval of approximately 60 to 180 minutes prior to anticipated time of surgery.
16276497|NCT00816335|Procedure|Preoperative 18F-FDG PET/CT Scan|Patients undergoing preoperative PET/CT scan day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained. PET imaging will immediately be preceded by noncontrast transmission CT (for attenuation correction and anatomic correlation purposes) and will be obtained from the base of the skull to the mid thighs. Bed positions will be scanned for 3 minutes each, moving the patient through the scanner in a craniocaudal direction. Once the preoperative PET/CT scan is acquired, images will be reviewed by the nuclear medicine physician and the surgeon.
16276498|NCT00816335|Drug|18F-FDG for patients with Bladder Cancer|Elimination of 18F-FDG by the urinary system and accumulation in the bladder impacts the differentiation between residual 18F-FDG in the bladder and activity in tumor and adjacent lymph nodes. For patients with bladder cancer, the urinary catheter routinely placed in the operating room will be inserted in the Ambulatory Surgery Unit (ASU) by the urologist on-service or the urology research nurse. A 3-way Foley catheter will be placed for continuous bladder irrigation with Normal Saline (0.9%) initiated in ASU and will continue for the duration of the imaging procedure at a standard rate of 10cc/minute. The urology research nurse will transport the patient to and from the PET/CT area and monitor the continuous bladder irrigation during the imaging session.
16276499|NCT00816335|Procedure|Surgical Procedure|Previously determined operative procedure based on type of solid malignancy. Factors include extent and location of disease, physiologic status of patient intraoperatively, any technical considerations influenced by anatomic constraints, and a risk: benefit analysis of proposed procedure. The decision to proceed with resection on these factors, and will constantly re-evaluate during resection to ensure patient well-being, both short and long term, is foremost consideration. Evaluation of extent of disease during surgical exploration will include inspection and palpation of entire area being evaluated. Tissue that is highly suspicious for involvement with metastatic disease that alters the surgical decision making plan of resection will be biopsied or resected for histologic confirmation if feasible and safe. If patient is found to have resectable disease, deemed safe patient, surgeon will continue and proceed with definitive surgical resection with assistance of handheld gamma probe.
16276500|NCT00816335|Procedure|Specimen PET/CT Scan|Resected surgical specimen will be placed on top of paraffin block. Digital photos of the specimen will be obtained for visual correlation of specimen placement on paraffin block. Two bed position 10 minute specimen PET/CT scan will be performed on surgical specimen. If remnant tissue is available, a second image maybe acquired via MRI. Images will be processed and reviewed for quality and presence or absence of hypermetabolic foci and correlated with anatomical information provided by CT and MRI imaging that were originally noted in the preoperative clinical PET/CT scan. During the time when the excised surgical specimens are transported to radiology for specimen PET/CT scanning, additional evaluation of these ex-vivo specimens with other tumor detection devices may be undertaken. Specimen will then be transported back to the operating room in order to be sent to and processed by surgical pathology for standard pathologic evaluation.
16276501|NCT00816322|Dietary Supplement|Omega-3 fatty acids|EPA 2.1 g/d+DHA 1.1 g/d
16276502|NCT00816322|Dietary Supplement|Placebo|high oleic oil
16276503|NCT00816309|Device|Acapella Physiotherapy|twice daily- around 20 minutes
16276504|NCT00816296|Other|Blood Draw|2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
16276505|NCT00816296|Other|Stool collection|Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
16276506|NCT00816296|Other|BodPod Measurement|Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
16276507|NCT00816296|Other|Liver Ultrasound|A liver ultrasound will be performed at study entry and 6 months after study entry.
16276508|NCT00816283|Drug|dasatinib|50 mg orally 2 times per day or 140 mg orally one time per day
16276509|NCT00816283|Drug|vorinostat|100 mg orally 2 times per day
16276510|NCT00816283|Genetic|cytogenetic analysis|Performed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL
16276511|NCT00816283|Genetic|gene expression analysis|Bone marrow aspirate obtained pre-treatment, at first scheduled bone marrow assay and at relapse. Peripheral blood drawn pre-therapy, day +14 of first treatment cycle and at relapse.
16276512|NCT00816283|Genetic|mutation analysis|Performed at baseline and at every bone marrow analysis on peripheral blood
16276513|NCT00816283|Genetic|reverse transcriptase-polymerase chain reaction|Peripheral blood drawn prior to starting Vorinostat on Day 1 and on Day 14 of treatment
16276514|NCT00816283|Other|flow cytometry|Performed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL
16276515|NCT00816283|Other|laboratory biomarker analysis|Performed pre-treatment and day +14 of treatment
16276516|NCT00816270|Procedure|Bilateral Upper eyelid blepharoplasty|Bilateral upper lid blepharoplasty was performed on each patient by the same experimented surgeon using a standard technique. One side (right or left upper eyelid) was randomly chosen for experimental closure with liquid bandage and the opposite eyelid served as the control being used a 6/0 nylon continuous sutures.
16276517|NCT00816244|Drug|Atorvastatin|Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.
16276518|NCT00816231|Behavioral|Tobacco|Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session.
16276519|NCT00816231|Other|Alcoholic Beverage|Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session.
16276586|NCT00815607|Biological|INXN-3001|Intratumoral injection
16276587|NCT00815594|Drug|bevacizumab|0.05ml, 1.25mg
16276520|NCT00816231|Other|Placebo|Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.
16276521|NCT00816218|Drug|Pioglitazone|pioglitazone, 45 mg daily
16276522|NCT00816205|Drug|Coated Nifedipine Suppositories|"Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:
~The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.
~The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine."
16276523|NCT00816192|Procedure|Long-term electrical isolation of pulmonary veins|All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.
16276524|NCT00816179|Procedure|Transgastric diagnostic endoscopic peritoneoscopy|Endoscopic abdominal exploration utilizing an endoscopically created gastrotomy.
16276525|NCT00816166|Device|Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)|Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
16276526|NCT00816166|Drug|Aspirin and Clopidogrel (Medical therapy)|Medical therapy alone [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
16276527|NCT00816153|Other|PVI-guided fluid management|Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)
16276528|NCT00816140|Drug|Cravit based triple therapy|"Levofloxacin based triple therapy
~LALa regimen: levofloxacin 750mg (levofloxacin500 1.5 tablets) once daily, amoxicillin 1000mg twice daily, lansoprazole 30mg twice daily for 7 days"
16276529|NCT00816140|Drug|Klaricid based triple therapy|"Clarithromycin based triple therapy
~CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days"
16276530|NCT00816127|Drug|Desmopressin|intranasal desmopressin (300μg)
16276531|NCT00816127|Biological|blood transfusion|fresh frozen plasma 10ml/kg and/or 1 unit of single donor platelets
16276532|NCT00816114|Other|Chart Review|Investigator review of MDACC CML patient charts.
16276533|NCT00816101|Other|Procellera™ Antimicrobial Dressing|Dressing indicated for partial and full-thickness wounds.
16276534|NCT00816101|Other|Mepilex® Border Lite|Self-adherent foam dressing
16276535|NCT00816101|Device|Adhesive Bandage|Adhesive bandage
16276536|NCT00816075|Drug|distilled water|we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours
16276538|NCT00816049|Drug|6MPindividualized|Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered
16276539|NCT00816049|Drug|6MPfixed|Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
16276540|NCT00816036|Behavioral|Smoking Cessation Guideline Implementation|"1. Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized quick orders for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit."
16276541|NCT00816023|Drug|ecallantide|infusion administered IV over the duration of the surgical procedure
16276542|NCT00816023|Drug|placebo|solution for IV infusion over the duration of the surgical>> procedure
16276543|NCT00816010|Behavioral|telephone contact|for lifestyle and compliance counseling
16276544|NCT00815997|Procedure|PCI (percutaneous coronary intervention)|PCI will be performed via the radial artery.
16276545|NCT00815984|Procedure|measurements of lung function tests|Measurement of the concentration of FeNO , measurement of spirometry, plethysmography, exercise challenge test (ECT -spirometric), bronchial obstruction reversibility pharmacological test
16276546|NCT00815958|Procedure|Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)|During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the RIA group (Arm A), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines up until femoral reaming. These patients will receive reaming with RIA. The remainder of the surgery will also be done according to the standard of care. TEE and TCD data will be recorded throughout the surgery.
16276547|NCT00815958|Procedure|Reaming with conventional reamer|During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the control group (Arm B), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines. These patients will receive reaming with the conventional method/reamer. TEE and TCD data will be recorded throughout the surgery.
16276548|NCT00815945|Drug|PegLiposomal Doxorubicin|PegLiposomal Doxorubicin, intravenous, 40mg/m², every 28 days for up to 6 months
16276549|NCT00815945|Drug|Carboplatin|Carboplatin, intravenous, AUC 6, every 28 days for up to 6 months
16276588|NCT00815581|Device|photorefraction,cycloautorefraction,cycloretinoscopy|
16276589|NCT00815568|Drug|fludarabine phosphate, busulfan|Fludarabine ( 30mg/m2, iv, D-7~D-2) Busulfan (3.2mg/kg, iv, D-6~D-3) Total body irradiation (200cGy/day, D-2,-1)
16276590|NCT00815555|Other|There is no intervention - this is an observational study|
16276550|NCT00815932|Device|TDCS/sham procedure on five consecutive days|The latency and amplitude of P300, subjective pain intensity, and pain thresholds for tactile and thermal stimuli will be determined at before and 15 min and 120 min after the 1st and 5th tDCS/sham procedure, To receive tDCS/sham treatment, two electrodes will be placed on the patient´s skull (for details see section Methods) and the patient will rest for 5 min. After that, the patient will receive 20 minutes of 2 mA tDCS/sham. Subjective pain intensity, and pain thresholds for tactile and thermal stimuli will be determined before-, 15 min after and 120 min after each tDCS/Sham procedure. At the 1st and 5th tDCS/Sham session, the latency and amplitude of P300 will be determined before-, 15 min after and 120 min after the tDCS/sham procedure.
16276551|NCT00815919|Drug|bortezomib|Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles
16276552|NCT00815919|Drug|Prednisone|Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.
16276553|NCT00815906|Drug|SBI-087|IV, Single dose
16276554|NCT00815906|Drug|SBI-087|IV, Single dose
16276555|NCT00815906|Drug|SBI-087|SC, Single dose
16276556|NCT00815906|Drug|SBI-087|SC, Single dose
16276557|NCT00815893|Drug|dexmedetomidine|dexmedetomidine 1.0 mcg/kg infusion for 10minutes
16276558|NCT00815893|Drug|Normal Saline 0.9%|0.9% Normal Saline 0.25ml/kg infusion for 10minues
16276559|NCT00815893|Drug|propofol 1%|"Propofol: The initial target = 3 μg/ml. The TCI is adjusted by 0.5μg/ml according to patient comfort during the procedure.
~The Orchestra® Base Primea(Fresenius, Brezins, France) offers a Target Controlled Infusion (TCI) target controlled infusion."
16276560|NCT00815880|Device|C-Pulse™ (Implantable Counterpulsation Therapy)|Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
16276561|NCT00815867|Drug|epoetin beta (NeoRecormon ®)|"comparison of administration of high dosage of epoetin vs no administration of epoetin
~30000 UI: 4 injections"
16276562|NCT00815854|Dietary Supplement|Folic Acid|5 mg of folic acid taken daily for 3 months in an open label fashion
16276563|NCT00815854|Other|Placebo|Subjects may receive placebo (a sugar pill) for 4 months
16276564|NCT00815841|Drug|METHYLPHENIDATE|15-20mg during one of the two sessions
16276565|NCT00815828|Other|Resistance exercises|Resistance exercises program consisting of 08 different exercises.
16276566|NCT00815815|Behavioral|Structured Behavioral Treatment|Daily therapy sessions and a weight gain protocol involving set meals and exercise levels
16276567|NCT00815789|Behavioral|Tailored cardiovascular risk management (Nurse-administered )|A nurse-administered intervention, which includes a behavioral and a medication management component. The intervention consists of very brief monthly telephone calls and occurs over 12 months. Upon request, participants may also be mailed additional supportive educational material to supplement phone intervention. They will also receive a letter clarifying medications reviewed with them during the nurse-administered intervention.
16276568|NCT00815776|Device|Clayton Intra-aural Device (CID)|"The CID is a patented small, hollow, ear insert made of medical grade polymers that is custom-fit to each subject's ear. Each subject that is randomized to the CID study group will wear a pair of inserts, one in each ear. (For the purpose of this protocol, the pair of inserts will be referred to as the CID)."
16276569|NCT00815776|Device|Mouth Splint|Group 2 subjects will be assigned to the active control device, which is current standard of care therapy. The device is an intraoral flat-planed splint full coverage plastic (hard) orthotic that fits over the occlusal one-third surfaces of the dentition. The appliance is made by taking a standard wax bite registration and is made using the standard technique of taking alginate impressions of the subject's teeth, pouring dental laboratory stone into the impression and processing the acrylic appliance on the stone model. This appliance raises the plane of occlusion and provides complete contact with the opposing dentition.
16276570|NCT00815776|Other|Exercise Group|Subjects assigned to Group 3 will be asked to track daily compliance with the protocol-specific exercise plan in their 4 week diaries. The exercise plan will consist of the following instructions: subjects will be instructed to open their jaw as far as possible, without pain and hold the jaw in that position for 5 seconds. Subjects will then close their jaw and rest 10 seconds. The exercise should be repeated exactly ten times in a row, with a 10 second rest in between each stretch. Subjects will be advised to apply a warm compress to the jaw area after completing their exercises for 10 minutes.
16276571|NCT00815763|Drug|ginsenoside-Rd|infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
16276572|NCT00815763|Drug|placebo|infusion placebo once a day and continued for 14 day
16276573|NCT00815750|Other|Information Gathering|An information gathering phase leading to development of a new decision aid.
16276574|NCT00815750|Other|Decision Aid|To test the newly developed decision aid.
16276575|NCT00815737|Drug|rhubarb|14 days of rhubarb
16276576|NCT00815737|Drug|Placebo|14 days of Placebo
16276577|NCT00815724|Behavioral|Distributed Asthma Learning Initiative (DALI) distance learning program|Participants will take part in two Webinar teleconferences, have access to an interactive Web site, and receive a CD-ROM of study materials and a toolkit.
16276578|NCT00815698|Procedure|suture|suture for mesh fixation
16276579|NCT00815698|Procedure|no suture|no suture for mesh fixation, because we use a self-adhesive mesh
16276580|NCT00815685|Drug|Eicosapentaenoic Acid|Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.
16276581|NCT00815672|Behavioral|Exercise|Progressive walking and resistance exercise treatment
16276582|NCT00815659|Drug|rosuvastatin|medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
16276583|NCT00815646|Drug|Sildenafil|After measurement of the effect of cold water on cardiac output and pulmonary artery and wedge pressures, a single dose of sildenafil (50 mg) will be given orally, followed by similar hemodynamic measurements.
16276584|NCT00815633|Drug|Alefacept|15mg intramuscular injection weekly for 12 weeks
16276592|NCT00815542|Drug|prostaglandins E2|prostaglandins E2 - Intravaginal Propess for 24 hours
16276593|NCT00815529|Device|Acupuncture, Pak-sham needle|25*40mm, from 10 to 15 per each person, with the death from 5 to 20 mm, for from 15 to 20 minutes.
16276594|NCT00815516|Drug|micafungin|Administered by intravenous infusion
16276595|NCT00815516|Drug|amphotericin B deoxycholate|Administered by intravenous infusion
16276596|NCT00815503|Drug|Ropivacaine|Approved by the Danish Medicines Agency
16276597|NCT00815503|Drug|Placebo|Saline
16276598|NCT00815490|Device|Desaturation|Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
16276599|NCT00815477|Behavioral|Web-based lifestyle counseling messages|10 email messages based on readiness-to-change over a 4 month period
16276600|NCT00815477|Behavioral|Generic Information|Waitlist control plus educational material on lifestyle behavior and hyptertension
16276601|NCT00815464|Device|Liquid Acupuncture (Herb Acupoint Injection)|Each 4 weeks per one circle.The first 3 weeks for treatment practice(one per week)and the last week for test collection.
16276602|NCT00815451|Dietary Supplement|placebo|polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks
16276603|NCT00815451|Dietary Supplement|Acticoa polyphenol-rich dark chocolate|20g to be distributed throughout the day for 4 weeks
16276604|NCT00815438|Procedure|cholecystectomy.|Patients enrolled in the study will have a flexible transvaginal endoscopy used during laparoscopic cholecystectomy.
16276605|NCT00815412|Behavioral|Counseling in use of health care|
16276606|NCT00815412|Behavioral|Counseling in diet, exercise|
16276607|NCT00815412|Other|Control|
16276608|NCT00815399|Drug|Pioglitazone|15-45 mg/die
16276609|NCT00815399|Drug|Metformin|500-2000 mg/die
16276610|NCT00815386|Device|Percutaneous transvenous mitral annuloplasty|Catheterization procedure with anesthesia requiring subclavicular puncture, catheterization of the right atrium and coronary sinus vein, placement and optimization of the PTMA device with access hub remaining subcutaneous at the clavicle.
16276611|NCT00815373|Drug|Dorzolamide+Timolol Maleate0.5%|Cosopt* b. i. d.
16276612|NCT00815373|Drug|Latanoprost+Timolol Maleate0.5%+Lytears|Xalacom* QHS
16276613|NCT00815360|Drug|intravitreal injection of ranibizumab|intravitreal injection of 0.5 mg ranibizumab
16276614|NCT00815360|Procedure|peripheral laser|ultra-widefield fluorescein angiography guided peripheral laser
16276615|NCT00815360|Drug|intravitreal injection of triamcinolone acetonide|intravitreal injection of 4.0 mg triamcinolone acetonide
16276616|NCT00815360|Procedure|macular laser|macular laser to areas of retinal thickening or leakage
16276617|NCT00815347|Drug|bosentan|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
16276618|NCT00815347|Drug|placebo|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
16276619|NCT00815334|Procedure|Endoscopic subureteric injection|Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
16276620|NCT00815321|Biological|Autologous CIK cell infusion|4 CIK cells will be infused into patients at regular 3-weekly intervals for 4 infusions. The target cell dose per infusion is 1x10e10 CD3 cells. For patients with uncontrolled accelerated or blastic transformation undergoing chemotherapy, this will be given at the nadir of lymphopenia following chemotherapy. For other patients this will be given without interruption of the ongoing treatment with Imatinib or other kinase inhibitor.
16276621|NCT00815308|Drug|cetuximab (Erbitux)|Cetuximab,injection,loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8)
16276622|NCT00815308|Drug|Paclitaxel|Paclitaxel,injection,loading dose 45 mg/m^2,(Day1 in every week for Weeks 2-8)
16276623|NCT00815308|Drug|Cisplatin|Cisplatin,injection,loading dose 20 mg/m^2,(Day1 in every week for Weeks 2-8)
16276624|NCT00815308|Radiation|Radiation|Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).
16276625|NCT00815295|Drug|Sorafenib|Phase 1 - Dose level 1 : Sorafenib will be given 200 mg twice daily oral, Phase 1 - Dose level 2 : Sorafenib will be given 400 mg twice daily oral, Phase 2 : Sorafenib will be given at the maximum tolerated dose from Phase 1
16276626|NCT00815295|Drug|Cetuximab|Cetuximab will be given at standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly.
16276627|NCT00815282|Other|Human papilloma virus vaccine (cervarix)|vaccination at 0, 1 and 6 months
16276628|NCT00815269|Drug|Halothane|Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen
16276629|NCT00815269|Drug|Isoflurane|Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
16276630|NCT00815269|Drug|Sevoflurane|Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
16276631|NCT00815269|Drug|Desflurane|Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
16276632|NCT00815269|Drug|Enflurane|Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
16276633|NCT00815256|Procedure|Collagen Cross Linking with Riboflavin and UVA light|The patients randomized and allocated to this group are submitted to the treatment with riboflavin and ultraviolet -A light, if they do not match any of the exclusion criterion. The treatment is done as follows:after topical anesthesia, the epithelial tissue was removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution were applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution were continuously applied onto the cornea every 5 min. After the procedure, a therapeutic contact lens and antibiotic eye ointment are applied onto the cornea for a week. We see the patient in the next day.
16276664|NCT00814957|Drug|GSK618334|D3 receptor antagonist
16276634|NCT00815243|Procedure|Telemedicine consultation|Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
16276635|NCT00815243|Procedure|Treatment plan|Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
16276636|NCT00815217|Procedure|injection of lipoaspirate|Small volume lipoaspiration will be performed. This technique involves harvesting small amounts of fat by making a small incision in the donor site (usually the abdomen) and infiltrating 25-75cc of tumescence solution (1 liter of LR, 30 cc of 1% lidocaine, 1 ampule of 1:1,000,000 epinepherine) into the adipose layer with a blunt infiltrator. The Coleman aspiration Cannulae, approximately 2-3 mm in diameter and 15 cm in length attached with a Luer-Lok suction syringe will be used to harvest up to 100 cc of fat. Gently pulling back on the syringe provides a small amount of negative pressure to allow for aspiration into the syringe.For the intervention wound, the adipose tissue will be implanted using the infiltration Cannulae (blunt end, 7 cm- COL-17) or the both approx. 1mm in diameter. The implantation will be in single tunnels radially around each wound spaced at 5-10 mm apart and approximately 3 - 5 cm in length.
16276637|NCT00815217|Other|control|For the control wound, only the sterile injectable tumescence solution (1 liter of LR, 30 cc of 1% lidocaine, 1 ampule of 1:1,000,000 epinepherine) will be used. The solution will be injected in a similar fashion with single tunnels radially around the control wound spaced at 5-10 mm apart and approximately 3 - 5 cm in length.
16276638|NCT00815204|Procedure|MRI of the pituitary|Patients will undergo a T1 weighted MRI of the pituitary to measure pituitary volume
16276639|NCT00815204|Procedure|DEX/CRH test|Subjects will have blood drawn for baseline ACTH, cortisol, and other hormones and then undergo a DEX/CRH test. Will then measure ACTH and cortisol on test.
16276640|NCT00815191|Device|a forced-air warming cover|A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.
16276641|NCT00815191|Device|vital HEAT (vH2) Temperature Management System|The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery.
16276642|NCT00815178|Behavioral|Inspiratory muscle training|For Inspiratory muscle training (IMT)patients carried out the IMT on a daily basis for eight weeks, with duration of 30 minutes and intensity corresponding to 30% of resting PImax, with a linear pressure resistance device (Threshold®). Weekly maximum inspiratory pressure (PImax) evaluations and workload adjustments were performed. Inspiratory load was adjusted on a weekly basis to maintain 30% of the subject's PImax. Training sessions were carried out at home for both groups and supervised once a week at the hospital.
16276643|NCT00815178|Behavioral|Inpiratory muscle training placebo|Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
16276644|NCT00815152|Behavioral|coping skills intervention training|The strategies will include ways to improve problem solving, communication skills, and managing activities.
16276645|NCT00815152|Behavioral|usual care|The ususal care at the Preston Robert Tisch Brain Tumor Center
16276646|NCT00815126|Procedure|Lysine-ASA Nasal ProvocationTest|Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
16276647|NCT00815100|Drug|Ivabradine|Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).
16276648|NCT00815100|Drug|Placebo|Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).
16276649|NCT00815087|Device|Functional electrical stimulation|15 sessions of VitalStim® therapy, 60 minutes per session
16276650|NCT00815087|Behavioral|Exercise home program|Daily exercise training
16276651|NCT00815074|Other|No intervention|no intervention
16276652|NCT00815048|Drug|Atropine/Remifentanil|"Atropine 20mcg/kg
~Remifentanil 3mcg/kg"
16276653|NCT00815048|Drug|Fentanyl/Atropine/Succinylcholine|"Atropine 20mcg/kg
~Fentanyl 2mcg/kg
~Succinylcholine 2mg/kg"
16276654|NCT00815035|Drug|Peanut OIT|Peanut flour that is orally ingested in a graded fashion.
16276655|NCT00815035|Drug|Placebo|Oat flour used as a placebo that is orally ingested a graded fashion
16276656|NCT00815022|Drug|bupivacaine/fentanyl/morphine|Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
16276657|NCT00815009|Behavioral|Mod Fat/Low Processed Carb Diet and Moderate Exercise|Follow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
16276658|NCT00815009|Behavioral|Low Fat Diet and Moderate Exercise|Follow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
16276659|NCT00815009|Behavioral|Moderate Exercise Only|No special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
16276660|NCT00814983|Procedure|Naive T-cell Depleted Stem Cell Transplant|"The Isolex device from Baxter will be used to perform the cell selection procedure. After the CD34 selected stem cell graft has been collected, the CD34- flow-throughfraction will be depleted of CD45RA+ naive T-cells. To accomplish this, a second immunomagnetic bead selection process will be performed on the Isolex device, making use of a GMP-grade murine anti-human CE45RA antibody. This depleted fraction will comprise the donor lymphocyte inoculum given to the transplant recipient along with the stem cell component on day 0 of transplant."
16276661|NCT00814983|Procedure|Stem Cell Transplant No Manipulation|These patients will be transplanted with unmanipulated peripheral blood stem cells.
16276662|NCT00814983|Device|Isolex device from Baxter|
16276663|NCT00814970|Device|Complete SE Vascular Stent System|Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
16276665|NCT00814944|Drug|Sirolimus|Subconjunctival injection of 440 micrograms sirolimus in each eye.
16276666|NCT00814944|Drug|Sirolimus|Subconjunctival injection of 220 micrograms sirolimus in each eye.
16276667|NCT00814944|Drug|Sirolimus|Subconjunctival injection of 880 micrograms sirolimus in each eye.
16276668|NCT00814944|Drug|Sirolimus|Subconjunctival injection of placebo in each eye.
16276669|NCT00814931|Drug|CXB722|900 mg CXB722 oral liquid suspension twice a day for 8 days
16276670|NCT00814931|Drug|Placebo|matching oral liquid suspension placebo twice a day for 8 days
16276671|NCT00814918|Drug|5-ALA with Blu-U Light|20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to DUSA Blu-U light (417nm).
16276672|NCT00814918|Drug|5-ALA with Candela V-beam Pulse Dye Laser|20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to Candela V-beam Pulsed Dye Laser (595 nm).
16276673|NCT00814905|Drug|saline|A saline infusion after delivery (one dose)
16276674|NCT00814905|Drug|ampicillin gentamicin|one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following their vaginal delivery
16276675|NCT00814905|Drug|Ampicillin gentamicin clindamycin|one dose of ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV, clindamycin 900 mg IV and then saline infusions instead of antibiotics until they are afebrile for 24 hours ( they will receive saline infusions instead of antibiotics)
16276676|NCT00814905|Drug|ampicillin gentamicin clindamycin|ampicillin 2 g IV every 6 hours, gentamicin 1.5mg/kg every 8 hours, and clindamycin 900 mg IV every 8 hours until the patient has been afebrile for 24 hours
16276677|NCT00814892|Biological|allogeneic tumor cell vaccine|Given intradermally
16276678|NCT00814892|Biological|therapeutic autologous dendritic cells|Given intradermally
16276679|NCT00814879|Drug|Raltegravir|400 mg BID
16276680|NCT00814879|Drug|Atazanavir|300 mg BID
16276681|NCT00814879|Other|Standard treatment regimen|N(t)RTI(s) based backbone plus ritonavir boosted PI
16276682|NCT00814866|Drug|Adalimumab|Adalimumab 40 mg sub-cutaneously every two weeks
16276683|NCT00814853|Device|NAVA (Extubation readiness testing failures)|Patients who fail the ERT will be place in the mode of ventilation NAVA.
16276684|NCT00814840|Device|Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads|Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)
16276685|NCT00814840|Device|Triple-site cardiac resynchronization|Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with three intraventricular leads: one in the right ventricle and two in the left ventricle (via the coronary sinus). Two left ventricular leads connected with Y-connector (Lead Adaptor 2827, Medtronic, Minneapolis, MN, USA)
16276686|NCT00814801|Drug|Placebo|Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.
16276687|NCT00814801|Drug|Galantamine 16 mg/day|Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks.
16276688|NCT00814801|Drug|Galantamine 24 mg/day|Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.
16276689|NCT00814788|Drug|Bicalutamide|50 mg oral tablet daily
16276690|NCT00814788|Drug|Everolimus|10 mg oral capsule daily
16276691|NCT00814775|Device|Fastrach Laryngeal Mask|Intubation of difficult airway using Fastrach Laryngeal Mask
16276692|NCT00814775|Device|CTrach Laryngeal Mask|CTrach Laryngeal Mask intubation
16276693|NCT00814762|Biological|HIV Vaccine 732462|Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.
16276694|NCT00814762|Biological|Placebo vaccine|Two doses of placebo, injected intramuscularly, at an interval of approximately one month
16276695|NCT00814749|Procedure|midureteral sling|midureteral sling
16276696|NCT00814749|Other|surgical therapy or conservative|midureteral sling or conservative; medication, physiotherapy
16276697|NCT00814736|Drug|UK369,003|oral tablet, once a day
16276698|NCT00814736|Drug|sildenafil|single oral dose on day 14 or day 17
16276699|NCT00814736|Drug|sildenafil matching placebo|single oral dose on day 14 or day 17
16276700|NCT00814723|Drug|fluvastatin|80 mg MR, 12 weeks
16276701|NCT00814723|Drug|Fluvastatin plus ezetimibe|fluvastatin 80 mg MR plus ezetimibe 10 mg
16276702|NCT00814710|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 3 doses
16276703|NCT00814710|Biological|Tritanrix-HepB/Hib|Intramuscular injection, 3 doses
16276704|NCT00814710|Biological|Hiberix|Intramuscular injection, 3 doses
16276705|NCT00814710|Biological|Tritanrix-HepB|Intramuscular injection, 3 doses
16276706|NCT00814697|Device|Repetitive Transcranial Magnetic Coil Stimulation (rTMS)|The first six patients were administered rTMS at 10Hz in 20 trains of 5 seconds with 20 second intervals between trains in each hemisphere. The total number of pulses for each session was set at 1000 pulses. The second six enrolled patients were administered rTMS at 15 Hz in 20 trains of 5 seconds with 25 second intervals between trains in each hemisphere.
16276707|NCT00814671|Drug|Rifapentine 450|rifapentine 450 mg
16276708|NCT00814671|Drug|Rifapentine 600|rifapentine 600 mg
16276709|NCT00814671|Drug|Rifampin|rifampin 600 mg
16276710|NCT00814658|Drug|Galantamine|Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day.
16276711|NCT00814658|Drug|Nimodipine|Nimodipine 30 mg 3 times a day (tid).
16276712|NCT00814658|Drug|Placebo|Matching placebo three times a day (tid).
16276713|NCT00814645|Drug|Sodium Nitrite Inhalation Solution|a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
16276791|NCT00814242|Procedure|surgical resection|radical resection performed in patinets with HCC.
16276714|NCT00814645|Drug|Placebo and AIR001 Inhalation Solution (Expansion arm)|On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
16276715|NCT00814632|Drug|CC-10004|CC-10004 20 mg. twice a day for 12 weeks
16276716|NCT00814619|Biological|panitumumab|Given IV
16276717|NCT00814619|Drug|capecitabine|Given orally
16276718|NCT00814619|Procedure|therapeutic conventional surgery|Patients undergo surgical resection
16276719|NCT00814619|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
16276720|NCT00814606|Drug|Fluvastatin|Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily
16276721|NCT00814606|Drug|Peginterferon alfa2a|180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9)
16276722|NCT00814606|Drug|ribavirin|1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
16276723|NCT00814593|Biological|lymphokine-activated killer cells|Instilled into the tumor bed cavity
16276724|NCT00814593|Drug|polifeprosan 20 with carmustine implant|Intracranial placement
16276725|NCT00814580|Drug|Tapentadol IR|First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed
16276726|NCT00814580|Drug|Oxycodone IR|First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed
16276727|NCT00814567|Radiation|radiation therapy|Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
16276728|NCT00814554|Behavioral|Educational strategy|1.Educational strategy. The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references. Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
16276729|NCT00814554|Behavioral|Screening strategy|2. Screening strategy. Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles. Screening will be performed by the school medical and nurse team. At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists. Subjects with psychological difficulties will be referred for psychological care.
16276730|NCT00814554|Other|Environmental strategy|3. Environmental strategy. The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy. Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.
16276731|NCT00814541|Drug|Bortezomib|
16276732|NCT00814541|Drug|Doxorubicin|
16276733|NCT00814541|Drug|Dexamethasone|
16276734|NCT00814528|Drug|5-ALA plus Blu-Light|20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.
16276735|NCT00814528|Drug|5-FU, Imiquimod or treatment with cryotherapy|Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.
16276736|NCT00814515|Drug|NOVA22007 (Ciclosporin 0.1%)|Ciclosporin 0.1% Ophthalmic Emulsions
16276737|NCT00814515|Drug|NOVA22007|Vehicle
16276738|NCT00814502|Drug|Zolpidem CR|After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
16276739|NCT00814502|Drug|Placebo|After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
16276740|NCT00814489|Biological|GSK2231395A|Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.
16276741|NCT00814489|Biological|Engerix-B|Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.
16276742|NCT00814476|Other|Medtronic CareLink therapy management system|At the first segment, the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. In the second phase of the study,during the following 4 months, there will be regular home use of the CareLink system, without support initiated by the diabetic team
16276743|NCT00814476|Other|regular home use and Medtronic CareLink Therapy Management|At the first 4 months patients will continue at their regular treatment and contacts initiated by the study team via internet/electronic mail will be made once a month. At the second segment of the study patients there will be home use of the CareLink System until the end of the study. No further contact will be initiated by the study team.
16276744|NCT00814463|Behavioral|MMSE|Neurocognitive function via MMSE done every 3 months for length of study.
16276745|NCT00814463|Behavioral|QOL via FACT-Br|Quality of Life via FACT-BR every 3 months for length of study.
16276746|NCT00814463|Procedure|MRI|MRI done every 3 months for the length of the study.
16276747|NCT00814463|Radiation|Post-operative SRS|Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
16276876|NCT00813761|Device|Proclear contact lens|control contact lens to be worn for entire length of study.
16276748|NCT00814450|Device|Biopsy needle guidance system (ActiSight™)|The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.
16276749|NCT00814424|Device|monitored using currently marketed smart biteblock o2|oral nasal CO2 monitoring and oxygen delivery
16276750|NCT00814424|Device|monitored using investigational smart biteblock|monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min
16276751|NCT00814411|Behavioral|group family planning counseling|group family planning counseling for gynecological patients with unmet need
16276752|NCT00814411|Behavioral|Individual family planning counseling|Individual family planning counseling with gynecological patients - the current standard of care
16276753|NCT00814398|Procedure|Double Embryo Transfer (DET)|Two embryos are transferred during an IVF treatment
16276754|NCT00814398|Procedure|Single Embryo Transfer (SET)|A single embryo is transferred during an IVF treatment
16276755|NCT00814385|Biological|Aflunov (Single prime, single boost)|Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
16276756|NCT00814385|Biological|Aflunov (Single prime, single boost)|Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
16276757|NCT00814385|Biological|Aflunov (single prime, single boost)|Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
16276758|NCT00814385|Biological|Aflunov (single prime, single boost)|Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
16276759|NCT00814385|Biological|Aflunov (Double prime, single boost)|Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
16276760|NCT00814385|Biological|Aflunov (double prime, single boost)|Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
16276761|NCT00814385|Biological|Aflunov (double prime, single boost)|Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
16276762|NCT00814385|Biological|Aflunov (double prime, single boost)|Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
16276763|NCT00814385|Biological|Aflunov (No prime, single boost)|No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
16276764|NCT00814372|Drug|MBX-102|capsule
16276765|NCT00814372|Drug|Placebo|matching placebo
16276766|NCT00814372|Drug|Actos|over-encapsulated to match MBX-102 and placebo
16276767|NCT00814372|Drug|Metformin|greater than or equal to 1500 mg/kg day
16276768|NCT00814359|Drug|Combination of Magic Mouthwash Plus Sucralfate|"Magic mouthwash will contain diphenhydramine powder 375mg, dexamethasone injection 2.8mg, and nystatin suspension 50ml (1000 units/ml) diluted to a total volume of 250ml with sterile water.
~The concentration of the sucralfate suspension will be 1g/5ml.
~Patients will be instructed to rinse first with 5ml of the magic mouthwash solution for 2 minutes then swallow, followed by rinsing with 5ml of the sucralfate suspension for 2 minutes before swallowing, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy."
16276769|NCT00814359|Drug|0.15% Benzydamine HCl|Patients will rinse with 15ml of 1.5mg/ml benzydamine HCl for 2 minutes then expectorate the solution, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.
16276770|NCT00814346|Drug|EGb761®|Four weeks for AD patients, 18 months for MC and CNE patients
16276771|NCT00814346|Drug|Placebo|Placebo 1 tablet BID
16276772|NCT00814333|Drug|Thrombin-JMI|5,000 IU, to nasal mucosa via syringe spray applicator
16276773|NCT00814333|Drug|Merocel pack|8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps
16276774|NCT00814320|Biological|Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)|"Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous [SC] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601.
~Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up)."
16276775|NCT00814320|Biological|Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)|"Comprises all other subjects.
~Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics.
~Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up)."
16276776|NCT00814307|Drug|CP-690,550|5mg CP-690,550 BID PO for 6 months
16276777|NCT00814307|Drug|CP-690,550|10 mg CP-690,550 BID PO for 6 months
16276778|NCT00814307|Drug|Placebo|Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
16276779|NCT00814307|Drug|Placebo|Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
16276780|NCT00814294|Drug|placebo|placebo capsule,0 units, quater in die (QID) for 18 weeks
16276781|NCT00814294|Drug|Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)|Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.
16276782|NCT00814294|Drug|Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)|Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.
16276783|NCT00814281|Other|placebo|Placebo
16276784|NCT00814281|Drug|Montelukast|10 mg ingested orally 1 hour prior to exercise testing
16276785|NCT00814268|Drug|Clopidogrel|75mg tablet, oral administration once daily
16276786|NCT00814268|Drug|Clopidogrel placebo|Matching tablet, oral administration once daily
16276787|NCT00814268|Drug|Aspirin|100mg tablet, oral administration once daily
16276788|NCT00814255|Drug|Adalimumab|Adalimumab 24 mg/m^2 (maximum dose 40 mg) sc q 14 days
16276789|NCT00814255|Drug|Lisinopril, losartan, and atorvastatin|Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day
16276790|NCT00814255|Drug|galactose|galactose 0.2 g/kg/dose (maximum dose 15 g)po BID
16276792|NCT00814242|Procedure|percutaneous radiationfrequency ablation|CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC
16276793|NCT00814229|Biological|H9N2 whole virus vaccine, IM, 1.5microg|influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
16276794|NCT00814229|Biological|H9N2 whole virus vaccine, IM, 5microg|influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
16276795|NCT00814229|Biological|H9N2 whole virus vaccine vaccine, IM, 15microg|influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
16276796|NCT00814229|Biological|H9N2 whole virus vaccine, IM, 45microg|influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
16276797|NCT00814229|Biological|H9N2 whole virus vaccine, alum, IM, 1.5microg|influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
16276798|NCT00814229|Biological|H9N2 whole virus, alum, IM, 5microg|influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
16276799|NCT00814229|Biological|H9N2 vaccine, whole virus, alum, IM, 15 microg|influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
16276800|NCT00814229|Biological|H9N2 vaccine, whole virus, alum, IM, 45microg|influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
16276801|NCT00814229|Biological|H9N2 virosome vaccine, IM, 1.5microg|influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
16276802|NCT00814229|Biological|H9N2 virosomal vaccine, IM, 5microg|influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
16276803|NCT00814229|Biological|H9N2 virosomal vaccine, IM, 15microg|influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
16276804|NCT00814229|Biological|H9N2 virosomal vaccine, IM, 45microg|influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
16276805|NCT00814229|Biological|H9N2 whole virus vaccine, ID, 5microg|influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
16276806|NCT00814229|Biological|H9N2 whole virus vaccine, ID, 15microg|influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
16276807|NCT00814216|Drug|QAV680|
16276808|NCT00814216|Drug|Matching placebo for QAV680|
16276809|NCT00814216|Drug|Fluticasone Propionate|
16276810|NCT00814190|Other|Internet Intervention|The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
16276811|NCT00814177|Drug|warfarin|No change: Continue without any change in spite of prothrombin time outside the therapeutic range.
16276812|NCT00814177|Drug|warfarin|Change: Increase one dose in case prothrombin time is below the therapeutic range; delete or reduce one dose in case prothrombin time is above the therapeutic range.
16276813|NCT00814164|Drug|clofarabine|IV
16276814|NCT00814164|Drug|daunorubicin hydrochloride|IV
16276815|NCT00814164|Genetic|cytogenetic analysis|Correlative study
16276816|NCT00814164|Genetic|protein expression analysis|Correlative Study
16276817|NCT00814164|Other|immunologic technique|Correlative Study
16276818|NCT00814164|Other|pharmacological study|Correlative Study
16276819|NCT00814151|Other|MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)|"In vitro diagnostic: The MicroPhage Intervention was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The Intervention results were not made available to the patient or their physician."
16276820|NCT00814138|Drug|Methotrexate|10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
16276821|NCT00814138|Other|Placebo|Weekly
16276822|NCT00814125|Drug|Anastrozole (Arimidex)|1mg, orally, once daily
16276823|NCT00814125|Drug|Tamoxifen (Nolvadex)|20mg, orally, once daily
16276824|NCT00814125|Drug|Nolvadex placebo|
16276825|NCT00814125|Drug|Arimidex placebo|
16276826|NCT00814099|Behavioral|Team approach to sedation management|"The team approach to sedation management includes the following:
~Team education and consensus on the use of sedatives
~Team identification of the patient's trajectory of illness and daily prescription of a sedation goal
~A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines
~Team feedback on sedation management performance"
16276827|NCT00814099|Behavioral|Usual approach to sedation management|The pediatric ICU will continue its usual approach to sedation management.
16276828|NCT00814086|Drug|Paclitaxel|Given IV or intraperitoneally
16276829|NCT00814086|Drug|Cisplatin|Given intraperitoneally
16276830|NCT00814073|Drug|Masitinib|Masitinib 6 mg/kg/day
16276831|NCT00814073|Drug|Placebo|Matching placebo
16276832|NCT00814073|Other|Best Supportive Care|Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.
16276833|NCT00814060|Drug|neratinib|HKI-272
16276834|NCT00814047|Drug|Yohimbine hydrochloride|
16276835|NCT00814021|Drug|sunitinib malate|
16276836|NCT00814008|Drug|Insulin|Insulin Dosage form : intravenous infusion, infusion period 60 minutes Dosage: continuous dose of 0.5 mU/kg/min infused intravenously over 60 min; Insulin Lilly, Huminsulin, Lilly, Fegersheim, France
16276837|NCT00814008|Drug|Glucose|"Glucose:
~Dosage form : intravenous infusion, infusion period 60 minutes per dose level Dosage: at a rate to maintain blood glucose level at 100mg ; 20mg/100ml Glucose"
16276838|NCT00813995|Drug|Comparator: Sitagliptin phosphate|All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.
16276877|NCT00813761|Device|ReNu MultiPlus Multi-Purpose Solution|lens solution for overnight lens disinfection
16276839|NCT00813995|Drug|Comparator: Placebo|All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.
16276840|NCT00813982|Device|Lotrafilcon A Experimental Contact Lens|Experimental spherical, silicone hydrogel soft contact lens
16276841|NCT00813982|Device|Lotrafilcon A Commercial Contact Lens|Commercially marketed spherical, silicone hydrogel soft contact lens
16276842|NCT00813969|Biological|Autologous mesenchymal stem cell transplantation|A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
16276843|NCT00813956|Drug|gemcitabine plus carboplatin plus BSI-201|iv, 3 week cycles
16276844|NCT00813943|Drug|Cilengitide (2-times weekly)|Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.
16276845|NCT00813943|Drug|cilengitide (5-times weekly)|Cilengitide 2000 milligram (mg) will be administered intravenously 5-times weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.
16276846|NCT00813943|Drug|Temozolomide|Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] will be administered intravenously once daily from Week 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression.
16276847|NCT00813943|Radiation|Radiotherapy|Radiation therapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Week 1 to 6, total dose 60 Gy.
16276848|NCT00813930|Behavioral|INTERxVENT lifestyle modification program|It is a lifestyle behavior modification program which helps Type 2 diabetics manage diabetes better and reduce cardiovascular risk factors. The program involves up to 12 telephone mentor/coaching sessions with a certified health professional.
16276849|NCT00813917|Drug|varenicline|12 weeks of varenicline 1 mg by mouth twice per day
16276850|NCT00813917|Drug|placebo|12 weeks of placebo (double blinded) by mouth twice per day
16276851|NCT00813904|Biological|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.
16276852|NCT00813891|Drug|Ranibizumab|Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
16276853|NCT00813891|Drug|Ranibizumab|Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
16276854|NCT00813891|Drug|Ranibizumab|Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
16276855|NCT00813878|Genetic|protein analysis|protein analysis
16276856|NCT00813878|Genetic|protein expression analysis|protein expression analysis
16276857|NCT00813878|Genetic|proteomic profiling|proteomic profiling
16276858|NCT00813878|Other|diagnostic laboratory biomarker analysis|Performed one time on study
16276859|NCT00813878|Other|immunohistochemistry staining method|Performed one time on study
16276860|NCT00813878|Other|liquid chromatography|Performed on samples collected one time on study
16276861|NCT00813878|Other|mass spectrometry|Performed on samples collected one time on study
16276862|NCT00813878|Procedure|fine-needle aspiration|Samples collected one time on study at the appointment for fine-needle aspiration where applicable
16276863|NCT00813878|Procedure|needle biopsy|Samples collected one time on study at the appointment for needle biopsy where applicable
16276864|NCT00813878|Procedure|radiomammography|Samples collected one time on study at the appointment for radiomammography where applicable
16276865|NCT00813865|Drug|afegostat tartrate|
16276866|NCT00813852|Behavioral|exercise training, IMT|Each exercise session includes graded treadmill walking and resisted exercises. The graded treadmill walking exercise begins with a 5 minute warm-up period with the intensity of about 40% of maximal oxygen consumption (VO2max) follows by a 30 minutes training phase. The training intensity is set at about 70%-85% of VO2max and ends with a 5-minute cool-down period with the intensity of about 40% of VO2max. The resisted exercise program includes 20 minutes of weight training with rest after the first 5 minutes.
16276867|NCT00813839|Other|daily weaning trails|daily SmartCare vs SBT until extubation criteria met
16276868|NCT00813826|Drug|SLC022|SLC022 150 mg capsule, 900mg daily dose
16276869|NCT00813826|Drug|Placebo|Placebo capsule, TID
16276870|NCT00813813|Drug|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
16276871|NCT00813800|Drug|Varenicline|Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
16276872|NCT00813774|Biological|Certolizumab pegol|Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg
16276873|NCT00813774|Biological|Certolizumab pegol|Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
16276874|NCT00813774|Biological|Certolizumab pegol|200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
16276875|NCT00813761|Device|O2Optix contact lens|control contact lens to be worn daily for approximately 7 months for entire length of study.
16276910|NCT00813540|Other|Usual Care|Usual Care
16276878|NCT00813761|Device|Clear Care Cleaning and Disinfecting Solution|lens solution for overnight lens disinfection
16276879|NCT00813748|Drug|Xolair|
16276880|NCT00813735|Drug|Eszopiclone|Eszopiclone 2mg daily at bedtime
16276881|NCT00813735|Drug|Placebo|Placebo daily at bedtime
16276882|NCT00813735|Drug|Escitalopram|Escitalopram 10mg or 20mg
16276883|NCT00813722|Behavioral|phone call|patients received or not phone calls to give orientation abou treatment
16276884|NCT00813722|Drug|amlodipine (calcium chanel blocker) and losartan (at1 antagonist)|2,5 mg tid and 25 mg tid
16276885|NCT00813722|Drug|atenolol (beta blocker) and hydrochlorothiazide (diuretic)|25 mg tid and 12,5 mg tid
16276886|NCT00813709|Drug|RNF|Single dose of RNF will be administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
16276887|NCT00813709|Drug|RNF|Single dose of RNF will be administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
16276888|NCT00813709|Drug|RNF|Participants who were initially randomized in Study 27025 (REFLEX) to the placebo treatment group will be switched to single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
16276889|NCT00813709|Drug|Placebo|Single dose matching placebo will be administered subcutaneously twice weekly. Placebo is supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 milliliter (mL).
16276890|NCT00813696|Drug|gemcitabine|1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks
16276891|NCT00813696|Drug|cisplatin|25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
16276892|NCT00813683|Other|Acupuncture stimulation|"Acupuncture by stimulation of 67 Bladder point"
16276893|NCT00813683|Other|Acupuncture stimulation|"Acupuncture stimulation of 45 Stomach point (sham)"
16276894|NCT00813670|Drug|XPF-001|Single oral dose, or 6 days of repeated oral doses.
16276895|NCT00813657|Behavioral|Exercise|Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, ~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (~8 minutes), followed by toning and very light resistance exercises (~20 minutes) and a light intensity cool-down (~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).
16276896|NCT00813631|Other|silver-releasing dressings|Experimental group are accepted primary dressing the AQUACEL Ag. control group are provided with the AQUACEL on the wound surface. Wound specialist or primary nurses undertaking wound care are informed by inclusion criteria that the treatment shall be adhered to during the two-week study period.All wounds are cleansed with sterile saline prior to assessment and dressing application.The sterile, non-woven sodium carboxymethylcellulose primary AQUACEL Ag with 1.2% ionic silver.Each secondary dressing is covered a sterile gauze.Dressings are changed between daily assessments when judged necessary.Patients attended the wound ward weekly for treatment evaluation. All participating clinics used the same wound management guidelines and data collection forms.
16276897|NCT00813618|Drug|MEDI-507|0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
16276898|NCT00813618|Drug|MEDI-507|0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
16276899|NCT00813618|Drug|MEDI-507|0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
16276900|NCT00813605|Other|FOLFIRI|"Day 1 of each Cycle
~Combination Therapy of:
~irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion"
16276901|NCT00813605|Biological|AMG 655|AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
16276902|NCT00813605|Other|Placebo|Inactive dummy agent (to maintain blind)
16276903|NCT00813605|Biological|AMG 479|AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
16276904|NCT00813592|Drug|SOM230B|SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
16276905|NCT00813566|Radiation|Multi-tracer PET exams of 18F-FDG, 18F-FLT, 11C-ACE, and 15O-H2O|"Baseline: prior to surgery or immediately after surgery and prior to any tumor-directed therapy;
~After the initial (~6-8 weeks) chemoradiotherapy;
~At the time of MRI-documented recurrence within 2 years (patients with a known primary brain tumor who have previously undergone treatment and have recurred will be eligible for study). The PET scanning will be implemented in two phases: Phase A (separate single-tracer scans with each tracer) will be completed with imaging over two consecutive days and Phase B (where two or more tracers will be imaged in a single scan using rapid multi-tracer PET techniques under development) in one or two imaging sessions according to the best method validated from the Phase A results. The exact order and timing of the multi-tracer exams will vary."
16276906|NCT00813553|Dietary Supplement|placebo|daily
16276907|NCT00813553|Dietary Supplement|beta-alanine|daily
16276908|NCT00813553|Dietary Supplement|beta-alanine|daily
16276909|NCT00813540|Behavioral|Exercise Training|The exercise group will perform supervised stationary cycle ergometer exercise 3 times per week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 110% of the power output obtained at V02peak. Resistance training will be completed twice per week and will include exercises for all major muscle groups. The training will progress from 60% to 80% of 1RM over the course of the intervention.
16276911|NCT00813527|Drug|Lapaquistat acetate and fenofibrate|Lapaquistat acetate 100 mg, tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks.
16276912|NCT00813527|Drug|Fenofibrate|Lapaquistat acetate placebo-matching tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks.
16276913|NCT00813514|Genetic|VEGF genotyping|blood sample for gene analysis
16276914|NCT00813501|Biological|immunosuppressive therapy|
16276915|NCT00813501|Other|immunological diagnostic method|
16276916|NCT00813501|Procedure|allogeneic hematopoietic stem cell transplantation|
16276917|NCT00813488|Drug|Fentanyl Buccal Tablet|"FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.
~The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).
~For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician."
16276918|NCT00813488|Drug|Immediate release oxycodone|"Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.
~The maximum single dose would be 60 mg (4 capsules)."
16276919|NCT00813475|Drug|Basal bolus insulin regimen (tight glucose control)|Basal bolus insulin regimen
16276920|NCT00813475|Drug|Basal bolus insulin regimen (standard control)|basal bolus insulin regimen
16276921|NCT00813449|Drug|dacarbazine plus Endostar (Experimental group)|dacarbazine plus Endostar
16276922|NCT00813449|Drug|dacarbazine plus placebo (control group)|dacarbazine plus placebo
16276923|NCT00813436|Drug|Oxytocin (also: syntocinon, pitocin)|24 IU for each subject (3 puffs in each nostril, 4 IU in each puff). each subject will receive a single administration, 40 minuets before task start time.
16276924|NCT00813436|Drug|Placebo|saline liquid, intranasally administered
16276925|NCT00813423|Drug|Hydroxychloroquine|Given PO
16276926|NCT00813423|Other|Laboratory Biomarker Analysis|Correlative studies
16276927|NCT00813423|Other|Pharmacological Study|Correlative studies
16276928|NCT00813423|Drug|Sunitinib Malate|Given PO
16276929|NCT00813410|Procedure|Glucose measurement at the sc. insulin delivery site|Overnight fasting and oral glucose tolerance test (OGTT) combined with simultaneous subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.
16276930|NCT00813397|Device|Sepraspray|Max. 10g of Sepraspray
16276931|NCT00813384|Drug|AMG 208|AMG 208 is a small molecule inhibitor of c-Met which is a well-characterized receptor tyrosine kinase expressed on the surface of epithelial cells. C-Met receptor signaling has been shown to play a key role in the survival of cancer cells. AMG 208 inhibits both ligand-dependent and ligand-independent c-Met cellular growth regulation. Inhibition of c-Met signaling with AMG 208 provides a potential mechanism for blocking tumor growth and survival.
16276932|NCT00813371|Device|Airway Pressure Release Ventilation|Airway Pressure Release Ventilation (APRV) also known as Bi-Vent or Bi-Level ventilation is a time-cycled, pressure-limited mode of ventilation that allows spontaneous respiration throughout the ventilator cycle.
16276933|NCT00813371|Device|ARDSnet protocol|ARDSnet protocol
16276934|NCT00813358|Device|Zenith TX2® TAA Endovascular Graft|Endovascular treatment with the study device
16276935|NCT00813345|Other|light therapy (1500 lux)|light therapy (1500 lux) for 90 minutes
16276936|NCT00813345|Other|standard light (100 LUX)|standard light (100 LUX) for 90 minutes
16276937|NCT00813332|Drug|Endostar(rh recombinant endostatin) plus Docetaxel|7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
16276938|NCT00813332|Drug|Placebo plus Docetaxel|Placebo plus Docetaxel
16276939|NCT00813319|Behavioral|Girls OnGuard|Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination.
16276940|NCT00813306|Drug|AZD2066|13 mg oral solution, 1 single dose
16276941|NCT00813306|Drug|Placebo|Oral solution, 1 single dose
16276942|NCT00813306|Drug|AZD2066|Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
16276943|NCT00813306|Drug|AZD2066|Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
16276944|NCT00813306|Drug|Placebo|Oral solution, 1 single dose
16276945|NCT00813293|Drug|Sorafenib|
16276946|NCT00813293|Procedure|radiofrequency ablation|
16276947|NCT00813267|Biological|mesenchymal stem cell infusion|
16276948|NCT00813267|Biological|bone marrow mononuclear cell infusion|
16276949|NCT00813254|Behavioral|Questionnaire|Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline.
16276950|NCT00813241|Drug|celecoxib reference formulation|200 mg single oral dose of celecoxib tablets
16276951|NCT00813241|Drug|celecoxib test formulation A1|150 mg single oral dose of celecoxib A1 formulation tablets
16276952|NCT00813241|Drug|celecoxib test formulation B2|150 mg single oral dose of celecoxib B2 formulation tablets
16276953|NCT00813241|Drug|celecoxib test formulation C1|150 mg single oral dose of celecoxib Cl formulation tablets
16276954|NCT00813228|Drug|Sitagliptin (Januvia)|
16276955|NCT00813215|Dietary Supplement|Meal challenge|Meal challenge with a test meal rich on saturated fat.
16276956|NCT00813215|Dietary Supplement|Meal challenge|Meal challenge with a test meal rich on monounsaturated fat
16276957|NCT00813202|Drug|Nesiritide|Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
16276958|NCT00813189|Device|GH treatment|GH treatment will be administered at a weekly dose of 0.46 mg/kg/ week, divided into seven daily subcutaneous injections. Subcutaneous injections should be given slowly, in the thigh. In order to prevent lipoatrophy, the injection site should be varied. The injection should be given at bedtime.
16276959|NCT00813176|Device|Double Lumen Endotracheal Tube|
16276960|NCT00813176|Device|Arndt Bronchial Blocker|
16277718|NCT00808210|Drug|Ocrelizumab|Intravenous repeating dose
16276961|NCT00813163|Drug|PEP02|"120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 days as a treatment cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16276962|NCT00813150|Drug|Dexamethasone|Type=exact number, number=20, unit=mg, form=tablet, route=oral. The patients will receive 20 mg of dexamethasone on days 1+2,4+5,8+9,11+12 for 21 days for 8 cycles.
16276963|NCT00813150|Drug|Bortezomib|Type=exact number, number=1.3, unit=mg, form=injection, route=intravenous. The patients will receive 1.3mg/m2 on days 1,4,8,11 for 21 days for 8 cycles.
16276964|NCT00813150|Drug|Cyclophosphamide|Type=exact number, number=50, unit=mg, form=tablet, route=oral. The patients will receive 50 mg of cyclophosphamide once daily continuously from cycle 1 to 8.
16276965|NCT00813137|Drug|Folfox4 plus recombinant human endostatin (Endostar)|Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16
16276966|NCT00813124|Drug|Fludarabine|40 mg/m^2 by vein over 60 minutes on Day -5 through Day -2.
16276967|NCT00813124|Drug|Busulfan|Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).
16276968|NCT00813124|Drug|Thymoglobulin|2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.
16276969|NCT00813124|Drug|Azacitidine|Start cycles of 32 mg/m^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.
16276970|NCT00813124|Procedure|Stem Cell Transplant|Stem cell infusion on day 0 administered by vein after collected from donor.
16276971|NCT00813111|Drug|SKY0402|600mg SKY0402 instilled into breast pocket during surgery
16276972|NCT00813111|Drug|Bupivacaine HCl|200mg Bupivacaine HCl instilled into breast pocket during surgery
16276973|NCT00813098|Drug|LX1031 High Dose|A high dose of LX1031; daily oral intake for 28 days
16276974|NCT00813098|Drug|LX1031 Low Dose|A low dose of LX1031; daily oral intake for 28 days.
16276975|NCT00813098|Drug|Placebo|Matching placebo dosing with daily oral intake
16276976|NCT00813085|Other|Electronic disease management decision support|A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)
16276977|NCT00813072|Drug|PEP02|"120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16276978|NCT00813072|Drug|irinotecan|300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16276979|NCT00813072|Drug|docetaxel|"75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16276980|NCT00813059|Drug|Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)|Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)
16276981|NCT00813046|Biological|gpASIT+TM|oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days
16276982|NCT00813033|Other|patient decision aid for endoscopy|patient decision aid will be administered at the point of decision making
16276983|NCT00813020|Drug|semaglutide|Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
16276984|NCT00813020|Drug|semaglutide|Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
16276985|NCT00813020|Drug|semaglutide|Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
16276986|NCT00813007|Behavioral|Questionnaires|5 Questionnaires at differing times before and after surgery.
16276987|NCT00812994|Drug|Escitalopram|SSRI antidepressant
16276988|NCT00812994|Drug|Placebo|
16276989|NCT00812981|Biological|GSK1562902A|new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm
16276990|NCT00812981|Biological|GSK1562902A|comparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm
16276991|NCT00812968|Drug|Lenalidomide|Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
16276992|NCT00812955|Drug|ABT-143|Once daily for 8 weeks
16276993|NCT00812955|Drug|simvastatin|Once daily for 8 weeks simvastatin capsules 40 mg
16276994|NCT00812942|Procedure|colonoscopy|colonoscopy screening
16276995|NCT00812942|Procedure|faecal test|faecal occult blood test for screening
16276996|NCT00812929|Drug|Placebo|The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915.
16276997|NCT00812929|Drug|GSK2190915|This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single dose of 10 mg, 50 mg, 100 mg, or 200 mg GSK2190915, compared to a placebo control.
16276998|NCT00812916|Procedure|RF ablation, using specialized CFAE software|RF ablation
16276999|NCT00812903|Behavioral|Exercise|Training exercises chosen with background in knowledge of intelligent training
16277000|NCT00812890|Device|semi-quantitative pregnancy test|
16277001|NCT00812877|Drug|Mineral Trioxide Aggregate|Pulp capping agent, Mineral TrioxideAggregate
16277002|NCT00812877|Drug|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide
16277003|NCT00812864|Drug|Capecitabine|"Pharmacokinetic of its metabolites.
~Capecitabine, 1250 mg/m2 twice a day"
16277004|NCT00812851|Drug|Dronabinol|
16277005|NCT00812838|Drug|100 units of Botulinum Toxin Type A|Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
16277006|NCT00812838|Other|Preservative free normal saline|Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque
16277007|NCT00812838|Drug|100 units Botulinum Toxin A|Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
16277008|NCT00812825|Drug|PF-04171327|PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.
16277009|NCT00812825|Drug|Prednisolone|Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days
16277010|NCT00812825|Drug|Placebo|Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
16277011|NCT00812825|Drug|Placebo Solution|Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.
16277012|NCT00812825|Drug|PF-04171327 Tablet|A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.
16277013|NCT00812812|Drug|paroxetine 10mg tablet|1 or 2 tablet(s) once a day
16277014|NCT00812812|Drug|paroxetine 20mg tablet|1 tablet once a day
16277015|NCT00812812|Drug|matched placebo to paroxetine 10mg|2 tablets once a day
16277016|NCT00812812|Drug|matched placebo to paroxetine 20mg|1 tablet once a day
16277017|NCT00812799|Drug|Oralgen|19.000 BU daily
16277018|NCT00812799|Other|placebo control|placebo control
16277019|NCT00812786|Drug|cyclosporine, tacrolimus, mycophenolate mofetil and everolimus (immunosuppressive drugs)|
16277020|NCT00812773|Drug|GSK2190915|Investigational Product
16277021|NCT00812760|Drug|levodopa|1 tablet of 200 mg levodopa plus 50 mg benserazide
16277022|NCT00812747|Other|observation|
16277023|NCT00812734|Procedure|Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)|Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)
16277024|NCT00812721|Other|Preservative Free Saline|One drop will be instilled into each eye once
16277025|NCT00812721|Other|Optive|One drop will be instilled into each eye once
16277026|NCT00812721|Other|Refresh Moderate/Severe|One drop will be instilled into each eye once
16277027|NCT00812721|Other|Systane|One drop will be instilled into each eye once
16277028|NCT00812721|Other|Systane Ultra|One drop will be instilled into each eye once
16277029|NCT00812708|Device|Morcher iris diaphragm implantation|Surgical implantation of Morcher iris device(s)
16277030|NCT00812695|Device|CPAP|Gold standard treatment for Obstructive sleep apnea
16277031|NCT00812682|Drug|Symbicort|
16277032|NCT00812669|Biological|pegfilgrastim|
16277033|NCT00812669|Biological|rituximab|
16277034|NCT00812669|Drug|cyclophosphamide|
16277035|NCT00812669|Drug|fludarabine phosphate|
16277036|NCT00812669|Genetic|cytogenetic analysis|
16277037|NCT00812669|Genetic|fluorescence in situ hybridization|
16277038|NCT00812669|Genetic|gene expression analysis|
16277039|NCT00812669|Genetic|mutation analysis|
16277040|NCT00812669|Genetic|protein expression analysis|
16277041|NCT00812669|Other|flow cytometry|
16277042|NCT00812669|Other|laboratory biomarker analysis|
16277043|NCT00812643|Drug|AZD0837|Oral solution, dosing through the Loc-I-Gut catheter, single dose
16277044|NCT00812630|Drug|MENT or placebo|A dose of 1600µg/d of MENT will be delivered daily using a gel formulation containing 8.0 mg of MENT per 1.0 mL (delivering 800µg/d). Two mLs of gel will be applied daily for four weeks in the pilot study (by 6 men) and for 12 weeks in the main trial (by 62 men).
16277045|NCT00812617|Dietary Supplement|Mineral water (Hita, Oita, Japan)|
16277046|NCT00812617|Dietary Supplement|Mineral water (Aso-gun, Kumamoto, Japan)|
16277047|NCT00812604|Drug|Ping On Ointment|Ping On Ointment
16277048|NCT00812604|Drug|Vaseline|Placebo
16277049|NCT00812591|Procedure|OGTT and CLAMP|"Oral Glucose Tolerance Test (OGTT):
~Oral glucose tolerance test combined with subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.
~Hyperinsulinemic euglycemic clamp (CLAMP):
~Hyperinsulinemic euglycemic clamp with simultaneous subcutaneous insulin delivery and glucose sampling using microdialysis and microperfusion probe."
16277050|NCT00812578|Drug|Cholecalciferol|8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
16277051|NCT00812565|Drug|Placebo|Commercially available 0.9% isotonic sodium chloride solution.
16277052|NCT00812565|Biological|octagam 10%|octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.
16277053|NCT00812539|Other|"Subject/Provider Portal Diabetes Connected Health tool - Deluxe"|"Subjects enrolled into the Deluxeintervention will use a glucometer, a modem to upload the blood glucose readings to a secure, web-based portal (Diabetes Connected Health tool) where they can view detailed graphical representation of their blood glucose levels over time, educational material regarding diabetes management and receive personalized tips and feedback from their physicians (who will also have access to their subjects' information on the web portal and contact them by an embedded messaging system). Subjects with new high or low readings will be flagged. Providers can initiate messages to subjects regarding symptoms or medications. A medication summary and log of all readings uploaded with date/time will be displayed on the website as well as a graphical display of all uploaded glucose readings over time and will allow subjects to enter comments regarding each critical reading."
16277054|NCT00812539|Other|"Subject only Portal Diabetes Connected Health Tool Basic"|"Patients enrolled in the Diabetes Connect Basic intervention will use a glucometer, a modem which will upload the blood glucose readings to a secure, web-based portal (the Diabetes Connected Health tool) where they can view their readings in a less detailed/journal fashion. No detailed graphical representation of their blood glucose levels over time is available to this group, nor is any educational material regarding diabetes management. Their physicians will not have access to these subjects' information on the web portal and will not have the ability to contact them by an embedded messaging system."
16277055|NCT00812526|Procedure|Suction cup application|
16277056|NCT00812526|Procedure|Squatting|
16277057|NCT00812513|Drug|R-Pdf/Gbb 0.01% gel|rhPDGF 0.01% gel is applied to the wound, then covered with dressing once daily for 3 months
16277058|NCT00812500|Other|Lower Protein|Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet.
16277059|NCT00812500|Other|Medium Protein|Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet.
16277060|NCT00812500|Other|Higher Protein|Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
16277061|NCT00812487|Drug|Intravenous insulin|Patients will receive continuous insulin infusion through the vein.
16277062|NCT00812487|Drug|Subcutaneous insulin|4 injections of insulin/day
16277063|NCT00812461|Drug|Placebo|as-needed use, tablets, orally, 6 months
16277064|NCT00812461|Drug|Nalmefene|18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
16277065|NCT00812448|Dietary Supplement|tea catechin extracts|catechins are composed of tea catechin extracts available in grren tea supplements
16277066|NCT00812435|Drug|eptifibitide|Patients will be randomized to eptifibatide or no eptifibatide. If randomized to eptifibatide: 180 mcg/kg Bolus; 2 mcg/kg/min infusion immediately prior to primary PCI or at the time of PCI and for 18 - 24 hours following the PCI Second 180 mcg/kg Bolus 10 min after the first
16277067|NCT00812422|Drug|Dexibuprofen|one dose of Dexibuprofen 2.5 or 5 mg/kg
16277068|NCT00812422|Drug|Dexibuprofen|one dose of Dexibuprofen 3.5 or 7 mg/kg
16277069|NCT00812422|Drug|Ibuprofen|one dose of Ibuprofen 5 or 10 mg/kg
16277070|NCT00812409|Dietary Supplement|Whey protein supplementation with exercise|Whey protein supplementation with resistance and aerobic exercise.
16277071|NCT00812409|Other|Non protein supplementation with exercise (control)|Non protein supplementation with resistance and aerobic exercise.
16277072|NCT00812396|Drug|Comparator: low dose testosterone|Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
16277073|NCT00812396|Drug|Comparator: high dose testosterone|Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
16277074|NCT00812396|Drug|Comparator: placebo|Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
16277075|NCT00812383|Device|RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System|Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation
16277076|NCT00812370|Drug|Bivalirudin|The initial bolus dose will be 0.125 mg/kg followed immediately by a continuous infusion of 0.125 mg/kg/hour.
16277077|NCT00812344|Drug|AZD0837|Oral solution, dosing through the Loc-I-Gut catheter, single dose
16277078|NCT00812344|Drug|Ketoconazole|tablets, orally, once daily for 3 days
16277079|NCT00812344|Drug|ketoconazole|dissolved tablets, dosing through the Loc-I-Gut catheter, single dose
16277080|NCT00812331|Drug|TMC435|From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
16277081|NCT00812318|Drug|GSK1265744 10 mg oral solution|GSK1265744
16277082|NCT00812318|Drug|GSK1265744 5 mg tablet|GSK1265744 5mg tablet, fasted
16277083|NCT00812318|Drug|GSK1265744 5 mg tablet|GSK1265744 5mg tablet, fed
16277084|NCT00812305|Drug|SKY0402 300mg in healthy patients|SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients
16277085|NCT00812305|Drug|SKY0402 300mg in hepatically impaired patients|SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients
16277086|NCT00812292|Drug|TMC278|
16277087|NCT00812279|Other|Distillation based smoking article (SMAR cigarette)|Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke.
16277088|NCT00812279|Other|conventional cigarette|Subjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke.
16277089|NCT00812279|Other|smoking cessation|Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.
16277090|NCT00812266|Drug|topotecan + cisplatin|topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
16277091|NCT00812266|Drug|Etoposide + carboplatin|Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W
16277092|NCT00812253|Drug|Intravenous insulin|Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
16277093|NCT00812253|Drug|Subcutaneous insulin|Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
16277094|NCT00812240|Drug|Masitinib|
16277095|NCT00812240|Drug|Imatinib|imatinib 400 mg or 600 mg per day, per os
16277096|NCT00812227|Behavioral|Psychodynamic Psychotherapy|Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.
16277097|NCT00812214|Drug|eszopiclone|3 mg qhs
16277098|NCT00812214|Drug|placebo|
16277099|NCT00812201|Device|No intervention is used. Collection of signals only.|Device received per standard of care.
16277100|NCT00812188|Other|Medium Dose UVA-1|UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.
16277101|NCT00812188|Other|High Dose UVA-1|High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.
16277102|NCT00812175|Drug|Sorafenib (Nexavar, BAY43-9006)|Systemic oral therapy according to product information
16277103|NCT00812162|Other|Energy Restriction|Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
16277104|NCT00812162|Other|Energy Restriction|Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.
16277105|NCT00812136|Behavioral|Using Parent Mentors to Improve Asthma Care for Urban Minority Children|
16277106|NCT00812123|Drug|Sirolimus|Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
16277107|NCT00812123|Drug|Cyclosporine A|Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
16277108|NCT00812123|Drug|Prednisone|0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
16277109|NCT00812123|Drug|Mycophenolate mofetil|2 x 1000mg, through level above 2ug/ml
16277110|NCT00812123|Procedure|Protocol biopsies|protocol kidney biopsies at month one and three
16277111|NCT00812110|Drug|Influenzae vaccine|0.5 mL Deltoid Intramuscular Injection X 1
16277112|NCT00812097|Device|Mentor Siltex® Contour Profile Gel Mammary Prosthesis|The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.
16277113|NCT00812071|Biological|RiVax|vaccine
16277114|NCT00812058|Drug|RG2417|1g bid dose escalates to 2g bid for weeks 2-8.
16277115|NCT00812058|Drug|Placebo|Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
16277116|NCT00812045|Drug|AZD1236|Oral tablet, 75 mg twice daily during 4 weeks
16277117|NCT00812045|Drug|Placebo|
16277118|NCT00812032|Drug|Aspirin|75 mg per day versus 75 mg twice daily and 320mg once daily
16277119|NCT00812032|Drug|aspirin|crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.
16277120|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59|Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.
16277121|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59|Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.
16277122|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59|Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.
16277123|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59|Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.
16277124|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59|Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.
16277125|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59|Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.
16277126|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59|Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.
16277127|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59|Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.
16277128|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59|Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.
16277129|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59|Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.
16277130|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59|Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.
16277131|NCT00812019|Biological|Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59|Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.
16277132|NCT00812006|Drug|rizatriptan benzoate|rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
16277133|NCT00812006|Drug|Comparator: placebo|Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
16277134|NCT00811993|Drug|RG1507|Starting dose of >=3mg/kg iv escalating to a maximum dose of <=16mg/kg iv, depending on dosing schedule in each combination treatment arm
16277135|NCT00811993|Drug|RO1507|27mg/kg iv, monotherapy
16277136|NCT00811993|Drug|bevacizumab [Avastin]|as prescribed
16277137|NCT00811993|Drug|capecitabine [Xeloda]|as prescribed
16277138|NCT00811993|Drug|carboplatin|as prescribed
16277139|NCT00811993|Drug|cetuximab|as prescribed
16277140|NCT00811993|Drug|docetaxel|as prescribed
16277141|NCT00811993|Drug|erlotinib [Tarceva]|as prescribed
16277142|NCT00811993|Drug|etoposide|as prescribed
16277143|NCT00811993|Drug|gemcitabine|as prescribed
16277144|NCT00811993|Drug|irinotecan|as prescribed
16277145|NCT00811993|Drug|mFOLFOX6|as prescribed
16277146|NCT00811993|Drug|paclitaxel|as prescribed
16277147|NCT00811993|Drug|pemetrexel|as prescribed
16277148|NCT00811993|Drug|sorafenib|as prescribed
16277149|NCT00811993|Drug|temozolomide|as prescribed
16277150|NCT00811993|Drug|trastuzumab [Herceptin]|as prescribed
16277151|NCT00811980|Drug|Linezolid or Vancomycin|Whole blood samples from healthy subjects will be incubated with MRSA bacterium or bacterial toxins in the presence and absence of either linezolid or vancomycin. Final concentrations will mimic physiologic conditions. Platelets and leukocytes will be isolated and assayed for the presence of absence of activation and pre-mRNA splicing.
16277152|NCT00811967|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron administered at a dose of 1.5 ug/kg QW SC for up to 48 weeks
16277153|NCT00811967|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered at a dose of 600, 800, or 1000 mg/day, orally, for up to 48 weeks.
16277154|NCT00811954|Drug|Emtricitabine/tenofovir disoproxil fumarate|200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
16277155|NCT00811954|Drug|Raltegravir|400 mg taken orally twice daily. An integrase inhibitor (INI).
16277156|NCT00811954|Drug|Darunavir|800 mg taken orally once daily. A protease inhibitor (PI).
16277157|NCT00811954|Drug|Ritonavir|100 mg taken orally once daily. A protease inhibitor (PI).
16277158|NCT00811954|Drug|Atazanavir|300 mg taken orally once daily. A protease inhibitor (PI).
16277159|NCT00811941|Drug|Placebo|as-needed use, tablets, orally, 52 weeks
16277160|NCT00811941|Drug|Nalmefene|18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
16277161|NCT00811928|Drug|Posaconazole|"40 mg/mL; 200 mg (5 mL) TID
~Treatment was continued with each cycle of chemotherapy until:
~The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
~3 chemotherapy cycles or
~Total treatment duration up to 12 weeks (84 days)"
16277254|NCT00811252|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets; daily; orally
16277162|NCT00811928|Drug|Fluconazole|"50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);
~400 mg QD
~Treatment was continued with each cycle of chemotherapy until:
~The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
~3 chemotherapy cycles or
~Total treatment duration up to 12 weeks (84 days)"
16277163|NCT00811915|Drug|Sirolimus|"Sirolimus introduction and tacrolimus withdrawal
~Tacrolimus : 33 % decrease of daily dose with complete withdrawal at day 14. Sirolimus daily dose according to CYP3A5 genotype CYP3A5*1/*1 or *1/*3: 4 mg/d CYPY3A5*3/*3 : sirolimus 2 mg/j Adjusted to obtain a trough level between 6 and10 ng/ml"
16277164|NCT00811902|Drug|Nerispirdine|tablet, oral administration
16277165|NCT00811902|Drug|placebo|tablet, oral administration
16277166|NCT00811889|Other|Placebo|Placebo
16277167|NCT00811889|Drug|Bardoxolone Methyl (RTA 402)|Oral, Once Daily
16277168|NCT00811876|Other|Data Collection on Depo-Eligard exposure|Retrospective, Non-interventional
16277169|NCT00811850|Drug|fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution|1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
16277170|NCT00811850|Drug|fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution|1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
16277171|NCT00811837|Drug|Midazolam|Intravenous infusion
16277172|NCT00811837|Drug|Remifentanil|Intravenous infusion
16277173|NCT00811824|Behavioral|Physical activity and dietary change|6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class
16277174|NCT00811811|Behavioral|Behavioral neurocardiac training|6 training sessions scheduled over 8 weeks
16277175|NCT00811811|Behavioral|Autogenic relaxation training|6 training sessions scheduled over 8 weeks
16277176|NCT00811798|Biological|Cervarix|Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
16277177|NCT00811785|Drug|Copper Histidine|Daily subcutaneous injections for three years
16277178|NCT00811772|Device|Percutaneous coronary intervention (PCI)|Implantation of one or more bare metal stent(s)
16277179|NCT00811772|Device|Percutaneous coronary intervention (PCI)|Implantation of one or more drug eluting stent(s)
16277180|NCT00811759|Drug|sorafenib tosylate|
16277181|NCT00811759|Drug|temozolomide|
16277182|NCT00811759|Genetic|gene expression analysis|
16277183|NCT00811759|Genetic|mutation analysis|
16277184|NCT00811759|Other|laboratory biomarker analysis|
16277185|NCT00811759|Other|pharmacological study|
16277186|NCT00811759|Procedure|biopsy|
16277187|NCT00811746|Drug|Rozerem (Ramelteon)|8 mg taken orally 30 minutes before a split-night PSG
16277188|NCT00811746|Drug|Lunesta (Eszopiclone)|3 mg taken orally 30 minutes before the start of a split-night PSG
16277189|NCT00811746|Other|Historical Controls|Chart review matched for demographics and comorbidities of the study drug groups.
16277190|NCT00811733|Biological|Ofatumumab|Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
16277191|NCT00811720|Drug|Placebo|as-needed use, tablets, orally, 6 months
16277192|NCT00811720|Drug|Nalmefene|18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
16277193|NCT00811694|Other|ocular blood flow measurements|non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
16277194|NCT00811681|Drug|pioglitazone|administered orally once a day after the first visit and for a total of 2 years. Initially, Pioglitazone will be started at 15mg /day. Dosage will then increase by 15mg /d/ week up to the maximal dose of 45mg /day
16277195|NCT00811681|Drug|Placebo|a placebo administered orally once a day after the first visit and for a total of 2 years.
16277196|NCT00811668|Device|CPAP before SOMNOVentCR|4 weeks CPAP treatment, 1 week wash out period, 4 weeks SOMNOventCR treatment
16277197|NCT00811668|Device|SOMNOventCR before CPAP|4 weeks SOMNOventCR treatment, 1 week wash out period, 4 weeks CPAP treatment
16277198|NCT00811655|Procedure|therapeutic conventional surgery|Surgery of a single brain metastasis.
16277199|NCT00811655|Radiation|stereotactic radiosurgery|Pre-operative single fraction SRS
16277200|NCT00811642|Drug|Posaconazole|400mg BID oral suspension for 12 weeks
16277201|NCT00811629|Other|sRAGE|The purpose of this observational prospective study is to determine wether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock
16277202|NCT00811616|Device|Supralimus-Core™|Sirolimus Eluting Cobalt Chromium based coronary stent system
16277203|NCT00811603|Drug|Cefazolin (Timing of Antibiotic Prophylaxis)|Patients scheduled for a cesarean delivery will be randomly assigned to receive Cefazolin (antibiotic prophylaxis) either prior to skin incision or after the clamping of the umbilical cord
16277204|NCT00811590|Drug|Everolimus|"Everolimus is a novel derivative of rapamycin. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation. Since 2003, RAD001 is approved in Europe (trade name: Certican) via the Mutual Recognition Procedure (MRP) for the prevention of organ rejection in patients with renal and cardiac transplantation. Certican is also approved in Australia, South Africa, the Middle East, Central and South America, the Caribbean and some Asian countries.
~Everolimus is being investigated as an anticancer agent based on its potential to act
~directly on the tumor cells by inhibiting tumor cell growth and proliferation
~indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell VEGF production and VEGF-induced proliferation of endothelial cells."
16277205|NCT00811577|Drug|Placebo|Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
16277255|NCT00811252|Drug|Duloxetine|encapsulated tablets; daily; orally
16277341|NCT00810654|Dietary Supplement|Aspergillus niger prolyl endoprotease|160 PPU daily for 2 weeks
16277206|NCT00811577|Drug|AZX100|AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
16277207|NCT00811564|Drug|fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution|1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
16277208|NCT00811564|Drug|latanoprost 0.005%|1 drop of study medication taken once daily
16277209|NCT00811551|Device|CRT-D (Intra-thoracic Impedance Monitoring)|Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes.
16277210|NCT00811538|Procedure|Intravenous Thrombolysis|i.V. thrombolysis with rtPa
16277211|NCT00811538|Procedure|Intraarterial Thrombolysis|Endovascular treatment with i.a. Urokinase or i.a. rtPA or mechanical recanalization techniques
16277212|NCT00811525|Device|Mentor Siltex® Contour Profile Gel Mammary Prosthesis|"The CPG mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. The Siltex® shell is textured to provide a disruptive surface for collagen interface. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The gel is made from the same materials as Mentor's standard gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness. The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant which may help the physician ensure proper placement. CPG was available in sizes 120 cc-775 cc and 5 styles with various projection and height options.
~With approval of MemoryShape™ (CPG 321) Breast Implants, the study converted to a post approval study for this style."
16277213|NCT00811499|Drug|ARRY-371797, p38 inhibitor; oral|multiple dose, single schedule
16277214|NCT00811499|Drug|Placebo; oral|matching placebo
16277215|NCT00811499|Drug|Placebo; oral|multiple dose, single schedule
16277216|NCT00811486|Drug|Spironolactone and conivaptan|Tablet, 50 mg to 200 mg, daily, orally 20 mg intravenously one time over 30 minutes
16277217|NCT00811473|Drug|Quetiapine XR|Oral treatment with 150 up to 300 mg/day once daily in the evening
16277218|NCT00811473|Drug|Placebo|Oral treatment once daily in the evening
16277219|NCT00811460|Drug|Placebo|sc for 4 days
16277220|NCT00811460|Drug|taspoglutide|300micrograms/day sc for 2 days
16277221|NCT00811460|Drug|taspoglutide|800 micrograms/day sc for 2 days
16277222|NCT00811447|Drug|5-fluorouracil|600 mg/m²/day intravenous
16277223|NCT00811447|Drug|Cisplatin|60 mg/m² or 75 mg/m² intravenous
16277224|NCT00811447|Drug|Docetaxel|60 mg/m² intravenous
16277225|NCT00811434|Drug|Lactulose|1.5cc/kg/day po for three months
16277226|NCT00811434|Drug|placebo|1.5 ml sugar water/kg day for three months
16277227|NCT00811421|Drug|Sulphadoxine-pyrimethamine|SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit
16277228|NCT00811421|Drug|Mefloquine (full dose)|MQ oral administration (15 mg/Kg) on 1 day at the 1st and 2nd Antenatal Clinic visit as IPTp
16277229|NCT00811421|Drug|Mefloquine (split dose)|MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp
16277230|NCT00811421|Drug|placebo|MQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp
16277231|NCT00811421|Drug|mefloquine|MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp
16277232|NCT00811408|Drug|carboplatin|
16277233|NCT00811408|Drug|cidofovir|
16277234|NCT00811408|Genetic|protein expression analysis|
16277235|NCT00811408|Other|laboratory biomarker analysis|
16277236|NCT00811408|Radiation|brachytherapy|
16277237|NCT00811408|Radiation|radiation therapy|
16277238|NCT00811395|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16277239|NCT00811395|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
16277240|NCT00811395|Drug|Interferon-β [IFN-β]|Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
16277241|NCT00811395|Drug|Glatiramer Acetate [GA]|Solution in prefilled syringe for subcutaneous injection
16277242|NCT00811382|Device|Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)|Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring
16277243|NCT00811382|Device|Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)|Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)
16277244|NCT00811369|Drug|Fulvestrant + ZACTIMA|ZACTIMA 100 mg tablets. Dose = 1 tablet daily until disease progression or intolerance
16277245|NCT00811369|Drug|Fulvestrant + Placebo|ZACTIMA Placebo 100 mg tablets. Dose = 1 tablet daily for duration of study.
16277246|NCT00811356|Drug|GSK932121; Rosiglitazone; Rosuvastatin|GSK932121 is the study drug that will be tested in all parts of this study as described above. Rosiglitazone and rosuvastatin will only be tested in the drug-drug interaction substudy.
16277247|NCT00811343|Biological|QFTB-G and T-SPOT.TB tests|QFTB-G and T-SPOT.TB test before TST
16277248|NCT00811330|Drug|Atorvastatin 80 mg|Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
16277249|NCT00811317|Device|Closed-loop|Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target
16277250|NCT00811291|Dietary Supplement|Vitamine-B and Folic Acid Complex, calcium|90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids
16277251|NCT00811291|Dietary Supplement|calcium|according to protocol
16277252|NCT00811265|Device|ExAblate MRgFUS for prostate cancer|Simulated use of ExAblate MRgFUS system
16277253|NCT00811252|Drug|Placebo|capsules; daily; orally
16277342|NCT00810654|Dietary Supplement|Placebo|Placebo
16277256|NCT00811239|Drug|Bungarus multicinctus-candidus Antivenom|Five to ten ampoules of antivenom, depending on severity of muscle paralysis, were diluted with isotonic glucose solution to have total 50 ml and infused intravenously by electric pump during one hour. After a period of 6-8 hours, a second infusion was administered, under similar condition to the first, if no clinical improvement or adverse reaction had been noted. The patients also received supportive care such as intubation, ventilation...if necessary.
16277257|NCT00811239|Other|Supportive Care|Supportive Care only (endotracheal intubation, mechanical ventilation...)
16277258|NCT00811226|Drug|olmesartan medoxomile alone or combined with hydrochlorothiazide,|olmesartan medoxomile 20mg/daily or 40mg/daily; olmesartan medoxomile 20mg plus 12.5 mg of hydrochlorothiazide daily; olmesartan medoxomile 40mg plus 12.5 mg of hydrochlorothiazide daily
16277259|NCT00811213|Device|SleepStyle 200 Auto Series with SensAwake|Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
16277260|NCT00811213|Device|SleepStyle 200 Auto Series with out SensAwake|Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
16277261|NCT00811200|Drug|ranibizumab|three initial monthly intra vitreal injections with 0.5 mg ranibizumab
16277262|NCT00811200|Drug|triamcinolone acetonide|at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
16277263|NCT00811200|Other|sham|at baseline one sham-injection
16277264|NCT00811187|Drug|Lidocaine paracervical block|5cc 1% lidocaine injection in each paracervical region
16277265|NCT00811187|Drug|Normal Saline|5cc Normal Saline injection in each paracervical region
16277266|NCT00811174|Drug|Octagam 10%|300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
16277267|NCT00811161|Device|Airgent|HA needle free injection, 3-4 treatments, 3-4 weeks apart
16277268|NCT00811148|Procedure|Tissue Bank|Collection of clinical data and tumor tissue.
16277269|NCT00811135|Drug|bevacizumab [Avastin]|15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
16277270|NCT00811135|Drug|capecitabine [Xeloda]|1000mg/m2 bid po on days 1-14 of each 3-week cycle
16277271|NCT00811135|Drug|trastuzumab [Herceptin]|8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
16277272|NCT00811122|Radiation|11C-PIB PET Scan|Participants will receive an 11C-PIB PET scan of the brain.
16277273|NCT00811122|Radiation|FDG-PET Scan|Participants will receive an FDG-PET scan of the brain.
16277274|NCT00811109|Device|Standard Hemodialysis|Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)
16277275|NCT00811109|Device|with Blood Volume Management (BVM®) only|Hemodialysis using Blood Volume on-line monitoring only. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® device (for blood volume monitor; Fresenius Medical Care, France)
16277276|NCT00811109|Device|with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring|Hemodialysis using Blood volume and Blood temperature on-line monitoring. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® and BTM® devices (for blood volume monitor and blood temperature management, respectively; Fresenius Medical Care, France)
16277277|NCT00811096|Drug|Tinidazole|2gms, p.o. q.d. for 5 days
16277278|NCT00811096|Drug|chloroquine|
16277279|NCT00811083|Drug|DMSA - dimercaptosuccinic acid|dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
16277280|NCT00811070|Drug|SKI-606 (Bosutinib)|"Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2.
~SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing."
16277281|NCT00811057|Drug|1 Magnesium Sulfate|Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
16277282|NCT00811057|Drug|Nifedipine|Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
16277283|NCT00811057|Drug|Indomethacin|Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
16277284|NCT00811031|Drug|Taxotere|75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
16277285|NCT00811031|Drug|Prednisone|5 mg twice a day by mouth.
16277286|NCT00811018|Drug|Sitaxsentan|Sitaxsentan 100 mg tablets once daily
16277287|NCT00811005|Radiation|8-methoxypsoralen or 5- methoxypsoralen|"Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
~Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet."
16277288|NCT00811005|Radiation|8-methoxypsoralen or 5methoxypsoralen|"PUVA treatment:
~Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
~Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet."
16277289|NCT00810992|Behavioral|Nutritional and behavioral program A|Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease
16277290|NCT00810992|Behavioral|Nutritional and behavioral program B|Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine
16277291|NCT00810979|Drug|SLx-4090|tablet
16277292|NCT00810979|Drug|SLx-4090|tablet
16277293|NCT00810979|Other|Placebo|matching tablet
16277294|NCT00810979|Drug|Statin|Subjects were dosed with the statin prescribed specifically by their prescribing physician.
16277295|NCT00810953|Drug|Pentamidine|two dose of 6 mg/kg with or without standard chemotherapy.
16277296|NCT00810940|Drug|AbelaDrug200|IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP < 20 mmHg, then IV 100 ml same schedule for 24 hours
16277297|NCT00810940|Drug|mannitol|mannitol plus standard treatment
16277298|NCT00810927|Procedure|Suction cup application|he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
16277299|NCT00810927|Procedure|Laser Doppler flowmetry|Measurement of choroidal blood flow
16277300|NCT00810927|Procedure|Measurement of intraocular pressure|
16277301|NCT00810914|Drug|bupivicaine epidural|bupivicaine continuous epidural infusion
16277302|NCT00810914|Drug|bupivicaine epidural infusion patient epidural|bupivicaine
16277303|NCT00810914|Drug|bupivicaine|patient controlled anesthesia only
16277304|NCT00810901|Behavioral|Organ Donor|Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
16277305|NCT00810901|Behavioral|Alcohol Prevention|Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
16277306|NCT00810888|Drug|recombinant activated factor VII|Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).
16277307|NCT00810888|Drug|placebo|An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)
16277308|NCT00810862|Drug|pimecrolimus active cream|Pimecrolimus 1% cream apply to affected study area twice daily for 21 days
16277309|NCT00810862|Other|placebo base cream|apply to affected study area twice daily for 21 days
16277310|NCT00810849|Drug|Prednisolone|Prednisolone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week.
16277311|NCT00810849|Biological|Mycobacterium w immunotherapy|Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Patients in the control arm of the Mycobacterium w comparison will receive a similar regime of placebo injections of normal saline in identically-packaged vials.
16277312|NCT00810836|Drug|BG00012|oral
16277313|NCT00810836|Drug|BG00012|Oral
16277314|NCT00810836|Drug|placebo|oral placebo
16277315|NCT00810810|Biological|Standard blood components|Transfusion, if ordered by physician, with unfiltered red blood cells and apheresis platelets
16277316|NCT00810810|Biological|Leukoreduced blood components|Transfusion, if ordered by a physician, of leukoreduced red blood cells and apheresis platelets
16277317|NCT00810810|Biological|Leukoreduced and irradiated|Transfusion, if ordered by physician, of gamma irradiated leukoreduced red blood cells and gamma irradiated apheresis platelets
16277318|NCT00810797|Drug|exemestane|Given orally
16277319|NCT00810797|Other|laboratory biomarker analysis|One year after completion of study treatment
16277320|NCT00810797|Procedure|quality-of-life assessment|One year after completion of study treatment
16277321|NCT00810797|Other|immunohistochemistry staining method|Correlative studies
16277322|NCT00810784|Behavioral|Education|(1) a risk-assessment tool completed at the time of a hospital admission, (2) structured educational sessions on VTE prevention, and (3) audit-feedback where institutional data was reviewed during the educational sessions. These sessions were given once to the clinical pharmacists and on three separate occasions to the medicine house officers.
16277323|NCT00810771|Behavioral|Standard Information|A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
16277324|NCT00810771|Behavioral|Preference-tailored Information|A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
16277325|NCT00810758|Drug|PF-04878691 3mg|Oral solution, 3mg, twice weekly, 2 weeks
16277326|NCT00810758|Drug|PF-04878691 6mg|Oral solution, 6mg, twice weekly, 2 weeks
16277327|NCT00810758|Drug|PF-04878691 9mg|Oral solution, 9mg, twice weekly, 2 weeks
16277328|NCT00810745|Procedure|starr|stapled transanal rectal resection
16277329|NCT00810732|Drug|Sitaxsentan|Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
16277330|NCT00810732|Drug|Nifedipine|Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)
16277331|NCT00810732|Drug|Placebo|Placebo for sitaxsentan, orally administered once daily (double blind arm)
16277332|NCT00810719|Drug|Erlotinib|Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
16277333|NCT00810719|Drug|gemcitabine|The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
16277334|NCT00810706|Drug|exemestane|Patients randomised to receive exemestane (25 mg/day) for 5 years.
16277335|NCT00810693|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
16277336|NCT00810693|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521: 1.5mg tid orally for 12 weeks
16277337|NCT00810693|Drug|Placebo|Matching Placebo tid orally for 12 weeks
16277338|NCT00810680|Drug|Valproic acid|Tab. Valproic acid will be started at a dose of 10 mg per kg per day in two or three divided doses. If well tolerated the dose will be increased to a maximum of 20 mg per kg per day and continued for a period of 3 months. The drug will be continued for another 3 months for a maximum of 6 months in responding patients. The drug will be stopped in all those who develop intolerable side effects or develop disease progression during therapy.
16277339|NCT00810667|Drug|Lu AE58054|twice daily oral dose (60 mg BID: total dose 120 mg/day)
16277340|NCT00810667|Drug|Placebo|twice daily oral dose
16277343|NCT00810641|Procedure|Gufoni maneuver|For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).
16277344|NCT00810641|Procedure|Head-shaking maneuver|For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.
16277345|NCT00810641|Procedure|sham maneuver|For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
16277346|NCT00810628|Behavioral|Cognitive Behavioral Therapy|Individual interviews and group discussion/training.
16277347|NCT00810615|Other|Hyperbaric oxygen @ 2.4 ATA|Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
16277348|NCT00810615|Other|Sham treatment|
16277349|NCT00810602|Procedure|reduced intensity, related donor stem cell transplant|"Fludarabine /Busulfan(FluBu2)regimen
~Fludarabine: 40 mg/m2/day in 0.9 NS, administered IV on days -5 to day -2 pre-transplant for a total of 4 doses. Busulfan: 3.2 mg/kg in 0.9 NS administered IV on days -5 and -4 for a total of 2 doses. Total body irradiation 200 cGy delivered in a single fraction will be given on day 0 for patients receiving an HLA-mismatched transplant."
16277350|NCT00810602|Drug|tacrolimus (standard GVHD prophylaxis)|Tacrolimus will begin on day -3, IV or oral. Target trough level for tacrolimus is 8-12 ng/ml. In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant
16277351|NCT00810602|Drug|mycophenolate (standard GVHD prophylaxis)|Mycophenolate will begin on day 0 at 10 mg/kg/dose (up to 1 gram per dose) every 8 hours orally or intravenously and will continue until day 28.
16277352|NCT00810602|Drug|vorinostat|"Vorinostat given at a dose 100 mg PO BID starting day -10. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
~Dose escalation/ de-escalation
~Ten subjects treated at a dose of 100 mg PO BID. If dosing modifications are not required, during the pre-engraftment period in more than 4 patients, AND no more than two observed drug related toxicities CTC grade 4 or higher [probably or definitely related to the drug] then vorinostat dose will be escalated to 200 mg PO BID.
~If dose escalation does not occur due to failure to meet the above criteria,then the study will enroll at the 100 mg PO BID dosing, subject to the protocol stopping rules.
~If dose escalation occurs, subjects will be treated at 200 mg PO BID dosing level. If the probability of unacceptable toxicity exceeds the rules in protocol, then the dose of vorinostat will be de-escalated to 100 mg PO BID for the remainder of study."
16277353|NCT00810589|Drug|Levemir|0,4 IE per kg bodyweight
16277354|NCT00810589|Drug|Humalog NPL Insulin|0,4 IE per kg bodyweight
16277355|NCT00810576|Drug|Vorinostat|Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
16277356|NCT00810576|Drug|Bortezomib|Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
16277357|NCT00810563|Drug|Saline solution (laparoscopic tubal ligation)|5ml of saline solution in each portal of the trocar (2 portals)
16277358|NCT00810563|Drug|Bupivacaine|5ml of bupivacaine 0.5% in each trocar portal
16277359|NCT00810550|Other|Carotid ultrasound|Measurement of intima-media thickness
16277360|NCT00810524|Drug|lamivudine|100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
16277361|NCT00810524|Drug|Telbivudine|600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
16277362|NCT00810524|Drug|Enticavir|0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
16277363|NCT00810524|Drug|Adefovir Dipivoxil Tablets|10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
16277364|NCT00810511|Device|Lotrafilcon A contact lens|Silicone hydrogel contact lens
16277365|NCT00810511|Device|Comfilcon A contact lens|Silicone hydrogel contact lens
16277366|NCT00810498|Device|Trilogy|Exposure for one hour on the Trilogy ventilator
16277367|NCT00810498|Device|Standard of Care|Exposure to participants current ventilator
16277368|NCT00810485|Drug|ADX10059|oral administration
16277369|NCT00810485|Drug|ADX10059|oral administration
16277370|NCT00810485|Drug|ADX10059|oral administration
16277371|NCT00810485|Drug|ADX10059 Matching Placebo|oral administration
16277372|NCT00810472|Other|HLA Matching|HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial [8]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method [6]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months.
16277373|NCT00810472|Procedure|Penetrating keratoplasty|Corneal transplantation.
16277374|NCT00810459|Device|Trilogy Ventilator|Exposure to one hour on the Trilog ventilator
16277375|NCT00810459|Device|Standard of Care|Exposure of one hour on the Participants prescribed ventilator
16277376|NCT00810446|Drug|rifabutin|"Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows.  1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily.
~2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily.
~3.Inhibition of disseminated Mycobacterium avium complex (MAC) disease associated with HIV infections : The usual adult dosage for oral use is 300 mg of rifabutin once daily.."
16277411|NCT00810160|Dietary Supplement|ProlactPlus|Group 1 infants will be fed a concentration of Permeate mixed with formula. The ProlactPlus will be increased each week as follows: week 1 95:5 (formula:ProlactPlus), week 2 90:10, week 3 85:15, week 4 80:20, and week 5 75:25. Caloric content is roughly as follows: week 1 21 cal/oz, week 2 22 cal/oz, week 3 23 cal/oz, week 4 24 cal/oz, and week 5 25 cal/oz.
16277719|NCT00808210|Drug|Placebo|Intravenous repeating dose
16277377|NCT00810433|Procedure|GO-LIF - Guided Oblique Lumbar Interbody Fusion|"All patients will undergo single-level instrumented interbody spinal fusion surgery with instrumentation.
~Upon induction of general anesthesia, the patient will be positioned prone on a radiolucent operating table and prepared according to standard hospital procedure. An interbody fusion will be performed according to standard procedure and as indicated by the surgeon. The interbody fusion portion of the surgery will be carried out using any current technique - such as PLIF, TLIF, PLF, PLLF, XLIF or ALIF. The fusion strategy can be performed in an open or minimally invasive manner, as indicated. The interbody device will be inserted after the screws trajectory will be drilled and a 4.5mm Trajectory holder is in place. This will assure the surgeon that no collision will occur between the interbody and the screws.
~Upon completion of the fusion stage of the surgery, SpineAssist will be used to introduce the GO-LIF screws for fixation of the spinal levels to be fused."
16277378|NCT00810407|Drug|rifabutin|"Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows.  1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily.
~2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily."
16277379|NCT00810394|Drug|Sorafenib|Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
16277380|NCT00810381|Drug|Nitroglycerin|intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step
16277381|NCT00810381|Drug|Isosorbide-Dinitrate|intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step
16277382|NCT00810381|Drug|Sodium-nitroprusside|intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step
16277383|NCT00810381|Drug|Physiologic saline solution (control substance)|intravenous infusion, infusion period 120 minutes
16277384|NCT00810368|Drug|Carnosine|500mg Carnosine x2 daily
16277385|NCT00810368|Drug|Placebo|Microcrystalline cellulose placebo tablets x2 daily
16277386|NCT00810355|Behavioral|Support Group|General support and problem solving for work activity
16277387|NCT00810355|Behavioral|Cognitive Behavior Therapy|Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
16277388|NCT00810355|Behavioral|Cognitive Remediation|Computerized training to enhance cognitive functioning.
16277389|NCT00810342|Behavioral|physical activity tailored|tailored telephone counseling, email feedback, and website resources over 12 months
16277390|NCT00810342|Behavioral|physical activity standard|standard print and website information on how to become more active
16277391|NCT00810316|Drug|Alprazolam|Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
16277392|NCT00810316|Drug|Alprazolam XR|Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
16277393|NCT00810316|Drug|Clonazepam|Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
16277394|NCT00810303|Drug|Ezetrol (ezetimibe) multiple dose|administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15))
16277395|NCT00810303|Drug|Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose|administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20)
16277396|NCT00810303|Drug|Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose|administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30)
16277397|NCT00810303|Drug|Sustiva (efavirenz) single dose|administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)
16277398|NCT00810290|Behavioral|lifestyle intervention|A group-based intervention including 13 group sessions complemented by three individual home visits was developed using principles of social learning theory and patient-centered counseling. The intervention was intended to increase awareness of diabetes prevention strategies, foster positive diabetes prevention attitudes (i.e., self-efficacy) and promote healthy lifestyle behaviors in the target Latino population using literacy-sensitive and culturally-tailored strategies and materials.
16277399|NCT00810277|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 24 weeks
16277400|NCT00810264|Device|CRT Therapy - LV Lead Registry|Collecting long-term safety and efficacy data on a market-released left ventricular lead.
16277401|NCT00810251|Device|MatrixRIB (FDA Approval # K081623)|MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
16277402|NCT00810238|Biological|C-Cure|Intraventricular injection
16277403|NCT00810212|Procedure|PLF with autograft|6 subjects
16277404|NCT00810212|Biological|PLF with NeoFuse|6 subjects low dose
16277405|NCT00810212|Biological|PLF with NeoFuse|6 subjects medium dose
16277406|NCT00810212|Biological|PLF with NeoFuse|6 subjects high dose
16277407|NCT00810199|Drug|tocilizumab [RoActemra/Actemra]|tocilizumab 8 mg IV every 4 weeks.
16277408|NCT00810199|Drug|methotrexate|Approximately 15-17 mg methotrexate capsule orally once a week.
16277409|NCT00810199|Drug|placebo|Placebo matching methotrexate capsule taken orally once a week.
16277410|NCT00810173|Behavioral|phone call support|The intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day.
16277458|NCT00809861|Procedure|external immobilisation|closed reduction and external fixation
16277779|NCT00807768|Other|Quality-of-Life Assessment|Ancillary studies
16277412|NCT00810160|Dietary Supplement|GOS galacto-oligosaccharides|Group 2 infants will have their formula supplemented with galacto-oligosaccharides (GOS) for each feeding as follows: week 1 0.25 g/dL, week 2 0.5 g/dL, week 3 1.0 g/dL, week 4 1.5 g/dL, and week 5 2.0 g/dL.
16277413|NCT00810160|Dietary Supplement|Bifidobacterium infantis|Group 3 infants will have their formula supplemented with B. infantis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
16277414|NCT00810160|Dietary Supplement|Bifidobacterium animalis|Group 4 infants will have their formula supplemented with B. animalis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
16277415|NCT00810147|Drug|BMS-708163|Capsules, Oral, 25 mg, once daily, 24 weeks
16277416|NCT00810147|Drug|BMS-708163|Capsules, Oral, 50 mg, once daily, 24 weeks
16277417|NCT00810147|Drug|BMS-708163|Capsules, Oral, 100 mg, once daily, 24 weeks
16277418|NCT00810147|Drug|BMS-708163|Capsules, Oral, 125 mg, once daily, 24 weeks
16277419|NCT00810147|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 24 weeks
16277420|NCT00810134|Procedure|Thrupass|Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
16277421|NCT00810134|Procedure|Bypass|Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
16277422|NCT00810121|Drug|ketoprofen 100 mg|100 mg b.i.d. for 5 days
16277423|NCT00810121|Drug|ketoprofen|150 mg b.i.d. for 5 days
16277424|NCT00810108|Drug|lopinavir/ritonavir (Kaletra®) tablets|The subject will bring their own prescription of lopinavir/ritonavir. The patient will take a witnessed dose of lopinavir/ritonavir with an 6 ounce glass of cool water (if taken whole) or mixed in 4 ounces of Jell-O brand pudding (if crushed).
16277425|NCT00810095|Device|MindFrame System|Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke
16277426|NCT00810082|Device|ActiveStep|ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.
16277427|NCT00810082|Other|Standard Physical Therapy for Fall Prevention|Standard physical therapy for fall prevention
16277428|NCT00810069|Drug|Duloxetine Hydrochloride|Flexible dose of 60 or 120 mg daily
16277429|NCT00810069|Drug|Escitalopram|10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
16277430|NCT00810056|Other|Assessment|Cognitive, academic achievement, and mental health screening assessment and report.
16277431|NCT00810056|Behavioral|Fostering Healthy Futures (FHF)|Weekly therapeutic skill groups and mentoring over a 9-month period.
16277432|NCT00810043|Device|Kyphon® Curette|The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
16277433|NCT00810030|Drug|Ferric carboxymaltose|Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight
16277434|NCT00810030|Drug|Iron Sucrose|"VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows:
~• 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes.
~The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes.
~The individual iron deficit will be calculated using the modified formula of Ganzoni.
~If the patient's body mass index is >25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height [m] x height [m].
~The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg.
~Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit."
16277435|NCT00810017|Drug|Etoposide|etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
16277436|NCT00810017|Drug|Trastuzumab|intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease
16277437|NCT00810004|Drug|Ferinject|Intravenous infusion of iron
16277438|NCT00809991|Radiation|hypofractionation|3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
16277439|NCT00809965|Drug|Rivaroxaban 2.5 mg|One tablet twice daily
16277440|NCT00809965|Drug|Rivaroxaban 5 mg|One tablet twice daily
16277441|NCT00809965|Drug|Placebo|One placebo tablet twice daily
16277442|NCT00809965|Drug|Standard of care|
16277443|NCT00809952|Procedure|recombinant FSH|
16277444|NCT00809939|Drug|17 alfa hydroxyprogesterone caproate|weekly injection of 250 mg until 34 weeks gestation
16277445|NCT00809939|Drug|natural progesterone|previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
16277446|NCT00809939|Drug|17 alfa hydroxyprogesterone caproate|weekly injection, 250 mg until 34 weeks gestation
16277447|NCT00809939|Drug|vaginal progesterone|daily vaginal progesterone 200 mg until 34 weeks gestation.
16277448|NCT00809926|Drug|Valsartan/aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
16277449|NCT00809926|Drug|Valsartan|Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks
16277450|NCT00809913|Drug|short treatment (ciprofloxacin)|7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days
16277451|NCT00809900|Dietary Supplement|Experimental|Administration of of 480 mL cranberry juice
16277452|NCT00809887|Drug|Micafungin lock therapy|
16277453|NCT00809874|Dietary Supplement|Casein|
16277454|NCT00809874|Dietary Supplement|Whey Isolate|
16277455|NCT00809874|Dietary Supplement|Whey Hydrolysate|
16277456|NCT00809874|Dietary Supplement|Alphalact-Albumin|
16277457|NCT00809861|Procedure|volar locking plating|open reduction and internal fixation
16277459|NCT00809848|Drug|AGN-210669 ophthalmic solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
16277460|NCT00809848|Drug|AGN-210669 ophthalmic solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
16277461|NCT00809848|Drug|AGN-210669 ophthalmic solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
16277462|NCT00809848|Drug|bimatoprost ophthalmic solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
16277463|NCT00809848|Drug|AGN-210669 vehicle ophthalmic solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
16277464|NCT00809835|Drug|Galantamine|Daily 8 mg galantamine capsule
16277465|NCT00809835|Behavioral|Computer Assisted Cognitive Behavioral Therapy (CBT)|CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.
16277466|NCT00809822|Drug|NPB-01|Intravenous immunoglobulin
16277467|NCT00809822|Drug|Placebo|Physiological saline
16277468|NCT00809809|Drug|Zicam (Ionic zinc)|33mmol/l of ionic zinc
16277469|NCT00809809|Drug|placebo|placebo swab
16277470|NCT00809796|Drug|pentamidine|one dose of 4 mg/kg to two dose of 4 mg/kg with possibility of escalated to two dose of 6 mg/kg with or without standard chemotherapy.
16277471|NCT00809783|Biological|tanezumab|Tanezumab 10 mg
16277472|NCT00809783|Biological|tanezumab|Tanezumab 5 mg
16277473|NCT00809783|Biological|tanezumab|Tanezumab 2.5 mg
16277474|NCT00809770|Behavioral|Contingency Management|Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence
16277475|NCT00809770|Behavioral|Non Contingent Control Condition|Opportunities to draw for rewards are provided three times a week for 12 weeks for providing urine analysis. Opportunities to earn rewards are not based on urine analysis results.
16277476|NCT00809757|Drug|Levalbuterol|90 ug Levalbuterol (2 actuations)
16277477|NCT00809757|Drug|Levalbuterol UDV TID|0.31 ug Levalbuterol UDV TID
16277478|NCT00809757|Drug|Placebo|Placebo (2 actuations)
16277479|NCT00809744|Drug|cholecalciferol|capsules, 20 000IU, twice a week, 6 months duration
16277480|NCT00809718|Drug|Raltegravir and rifapentine|"Period 1- Raltegravir 400 mg q12h by mouth for 4 days
~Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days
~Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days"
16277481|NCT00809705|Drug|Placebo|sc once weekly for 12 weeks
16277482|NCT00809705|Drug|taspoglutide|10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
16277483|NCT00809705|Drug|taspoglutide|10mg sc once weekly for 12 weeks
16277484|NCT00809692|Procedure|validated techniques for histamine response|the prick test and iontophoresis technique (serial assessment of blood flow using validated Doppler technique)
16277485|NCT00809692|Procedure|new technique for histamine response|laser Dopper technique and genotyping
16277486|NCT00809679|Drug|T-62 Dose 1|Capsule dosage form 100 mg bid
16277487|NCT00809679|Drug|T-62 Dose 2|Capsule dosage form 200 mg bid
16277488|NCT00809679|Other|Placebo|Capsule dosage form placebo bid
16277489|NCT00809666|Device|Automated blood pressure recording device Omron HEM 705CP|All subsequent blood pressure recordings done using the automated device
16277490|NCT00809653|Device|No Face Mask|Subjects will not wear a face mask to reduce their personal air pollution exposure
16277491|NCT00809653|Device|Face Mask|Subjects will be asked to wear a simple face mask to reduce personal exposure to particulate air pollution. Subjects will be asked to wear the mask for 24 hours prior to the study day and the 24 hours of the study day. They will be instructed to wear the mask at all times when outdoors and as much as possible when indoors.
16277492|NCT00809640|Behavioral|Education (Back Comic-Book)|Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.
16277493|NCT00809627|Drug|Caffeine|Caffeine 500 mg IV
16277494|NCT00809627|Drug|saline|Normal saline
16277495|NCT00809614|Biological|AIN457|The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.
16277496|NCT00809614|Biological|Placebo|Matching placebo to AIN457
16277497|NCT00809601|Device|Insertion of a specific type of ventilation tube through the tympanic membrane|"The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear.
~The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested.
~The first combination will test:
~Shepard tube (double flanged, Fluoroplastic) vs Donaldson tube (double flanged, silicone)
~The second combination will test:
~Straight tube (single flanged, Fluoroplastic) vs Armstrong (single flanged, silicone)
~The third combination will test:
~Armstrong (single flanged, silicone) vs Donaldson tube (double flanged, silicone)
~The fourth combination will test:
~Straight tube (single flanged, Fluoroplastic) vs Shepard tube (double flanged, Fluoroplastic)"
16277498|NCT00809588|Biological|Autologous, lethally irradiated melanoma cells|Engineered to secrete human granulocyte-macrophage stimulating factor. Given on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out
16277499|NCT00809575|Other|questionnaire administration|
16277500|NCT00809575|Other|fatigue assessment and management|
16277501|NCT00809575|Other|observation|
16277502|NCT00809575|Other|quality-of-life assessment|
16277503|NCT00809562|Drug|Placebo|po daily for 10 days
16277504|NCT00809562|Drug|RO4917523|orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
16277505|NCT00809549|Drug|Filgrastim|10 ug/kg sc once daily x 4 days. Repeated once, 6 weeks later.
16277601|NCT00808977|Drug|Mesalazine|Mesalazine 2400 mg daily
16277506|NCT00809536|Drug|Metformin|225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
16277507|NCT00809536|Drug|Metformin|Single, oral, 500 mg of metformin immediate release
16277508|NCT00809536|Drug|PD 0332334|500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
16277509|NCT00809536|Drug|PD 0332334|Single, oral, 300 mg dose of PD 0332334 immediate release formulation
16277510|NCT00809523|Device|Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
16277511|NCT00809523|Device|Light-emitting Photodiode light treatment device|Light-emitting Photodiode light treatment device, used for 30 min before 8 am
16277512|NCT00809510|Drug|ABT-089|20 mg ABT-089 taken once-daily for 6 months
16277513|NCT00809497|Drug|Propionyl-L-carnitine Tablets|500mg tablets, oral administration of 2g daily
16277514|NCT00809471|Drug|placebo|30 minutes orally prior to initiation of sexual activity
16277515|NCT00809471|Drug|avanafil|30 minutes orally prior to initiation of sexual activity
16277516|NCT00809471|Drug|avanafil|30 minutes orally prior to initiation of sexual activity
16277517|NCT00809458|Drug|Vitamin E|Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
16277518|NCT00809445|Behavioral|On-site HIV rapid test and brief, prevention counseling|Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
16277519|NCT00809445|Behavioral|On- site HIV rapid test & information|Participants will be offered an on-site oral fluid HIV rapid test with basic info.
16277520|NCT00809445|Behavioral|Referral for off-site HIV testing|Participants will be offered a referral list of HIV testing agencies in the community.
16277521|NCT00809432|Device|Face mask (Dust Respirator)|Subjects to wear a simple face mask for 24 hours prior to the study day and the 24 hours of the study day. They will be instructed to wear the mask as much as possible when indoors and at all times when outdoors.
16277522|NCT00809432|Other|No Face mask|Subjects will not wear a face mask to reduce their personal exposure to air pollution
16277523|NCT00809419|Device|NeoVista Ophthalmic System|A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.
16277524|NCT00809393|Drug|tranexamic acid|10 mg/kg
16277525|NCT00809393|Drug|tranexamic acid|30 mg/kg
16277526|NCT00809380|Behavioral|Parental presence|Patients in the study group will be accompanied by one of their parents for the whole procedure. Before this, a short explanation of the procedure, the patient's expected behavior during the procedure and what roles parents should play will be given to the parent by the research assistant. Parents will be seated close to the patient's head and will wear radiology proof gowns. If deemed necessary by the attending physician or if their behavior becomes unacceptable, parents can be asked to leave the procedure room at any given time. Parents will be allowed to leave the procedure room if they wish to at any time during the procedure.
16277527|NCT00809380|Behavioral|Control|One parent will stay with their child until he is in the procedure room and conscious sedation has begun. He will then be asked to leave the room and wait in an adjoining waiting room. The attending physician will invite the parent back in the room once the reduction is complete and the cast is done.
16277528|NCT00809367|Other|Collection of Leukemia Cells|Collection of leukemia cells either by 1) routine blood draw 2) bone marrow aspirate or 3) leukopheresis
16277529|NCT00809354|Drug|NSAID|IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
16277530|NCT00809354|Biological|tanezumab|IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
16277531|NCT00809354|Biological|tanezumab|IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
16277532|NCT00809354|Biological|tanezumab|IV tanezumab 5 mg every 8 weeks (through Week 48)
16277533|NCT00809354|Drug|NSAID|Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
16277534|NCT00809354|Biological|tanezumab|IV tanezumab 10 mg every 8 weeks (through Week 48)
16277535|NCT00809354|Drug|NSAID|Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
16277536|NCT00809341|Biological|Rituximab|375 mg/m^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m^2 on Days 1, 30, and 37 as part of HiCy.
16277537|NCT00809341|Drug|Cyclophosphamide|750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
16277538|NCT00809341|Drug|Doxorubicin|50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
16277539|NCT00809341|Drug|Vincristine|1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
16277540|NCT00809341|Drug|Prednisone|100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
16277541|NCT00809341|Drug|Ifosfamide|2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
16277542|NCT00809341|Drug|Carboplatin|Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
16277543|NCT00809341|Drug|Etoposide|100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
16277544|NCT00809341|Drug|High-dose cyclophosphamide|50 mg/kg/day on Days 2-5 of HiCy.
16277545|NCT00809341|Procedure|PET scan|Performed once between Days 16-20 of cycle 3 of R-CHOP.
16277546|NCT00809328|Drug|Azithromycin|The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
16277547|NCT00809315|Other|Assessment|Cognitive, academic achievement, and mental health screening assessment and report.
16277548|NCT00809315|Behavioral|Fostering Healthy Futures (FHF)|Weekly therapeutic skill groups and mentoring over a 9-month period.
16277549|NCT00809302|Drug|aplindore MR tablets or Placebo|aplindore MR tablets administered BID for about 13 weeks
16277602|NCT00808977|Drug|Placebo|Placebo matching active and experimental treatments
16277780|NCT00807768|Other|Questionnaire Administration|Ancillary studies
16277550|NCT00809289|Drug|esreboxetine|Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind.
16277551|NCT00809289|Drug|placebo|Once daily administration of placebo for 9 days. Placebo will be administered double blind
16277552|NCT00809289|Drug|moxifloxacin|Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
16277553|NCT00809276|Drug|Busulfan, Fludarabine, Cytoxan|"Busulfan once a day for 4 days
~Fludarabine once a day for 4 days
~Bone marrow transplant
~Cytoxan two doses"
16277554|NCT00809263|Drug|homeopathic remedy|Homeopathic remedy 12C potency, 10 drops TID X 7 days
16277555|NCT00809250|Biological|GM-K562/leukemia cell vaccine|Cultured cell line genetically changed to secrete GM-CSF mixed with irradiated leukemia cells obtained from the participant. A total of 6 vaccine will be given. Vaccines 1-3 will be given once a week. Vaccines 4-6 will be given every other week.
16277556|NCT00809237|Drug|Gefitinib, Hydroxychloroquine|Gefitinib 250 mg om Hydroxychloroquine at maximally tolerated dose
16277557|NCT00809211|Drug|nilotinib|
16277558|NCT00809211|Genetic|cytogenetic analysis|
16277559|NCT00809211|Genetic|mutation analysis|
16277560|NCT00809211|Genetic|polymerase chain reaction|
16277561|NCT00809211|Other|pharmacological study|
16277562|NCT00809198|Other|Sodium Hyaluronate|
16277563|NCT00809198|Other|Carboxymethylcellulose sodium|
16277564|NCT00809185|Drug|everolimus|Patients will receive monotherapy with RAD001(everolimus)for 21 days within the 28 day cycle.
16277565|NCT00809185|Other|laboratory biomarker analysis|Laboratory correlates (cytotoxic t cell populations, S6K1 levels, GSTT-1 mutations, and the presence or absence of HLA-DR15) will be assessed to see if any of these correlates correspond to response.
16277566|NCT00809185|Procedure|Bone marrow aspirate/biopsy|Bone marrow aspirate and biopsy with cytogenetics should be obtained within 4 weeks prior to starting drug and at week 33. A bone marrow aspirate and biopsy should also be obtained for patients going off study prior to week 33 (including cytogenetics). The percentage of blasts on the aspirate should be used to determine the IPSS score.
16277567|NCT00809172|Drug|Ciclosporin|5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
16277568|NCT00809172|Drug|Methotrexate|15 mg/week per os in one tablet during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
16277569|NCT00809159|Biological|AIN457|AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
16277570|NCT00809159|Drug|Placebo|Placebo to AIN457
16277571|NCT00809146|Drug|Intramuscular route of active treatment|IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
16277572|NCT00809146|Drug|Intravenous route of active treatment|IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
16277573|NCT00809133|Drug|Paclitaxel|Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.
16277574|NCT00809133|Drug|Carboplatin|AUC6 given on day 1 of 21 day cycle
16277575|NCT00809133|Drug|BIBW 2992|Escalating dose cohorts
16277576|NCT00809133|Drug|Paclitaxel|Part A and B:80mg/m2 given on Day 1, 8 and 15 of 28 Day cycle.
16277577|NCT00809133|Drug|BIBW2992|MTD dose of part A
16277578|NCT00809133|Drug|Paclitaxel|175mg/m2 given on Day 1 of 21 Day cycle
16277579|NCT00809133|Drug|Carboplatin|AUC6 given on day 1 of 21 day cycle
16277580|NCT00809133|Drug|Bevacizumab|Escalating dose Cohorts - 5mg / kg, 7.5mg / kg and 10mg / kg given Day 1 and Day 15 of a 28 days cycle
16277581|NCT00809133|Drug|BIBW 2992|Escalating dose cohorts
16277582|NCT00809133|Drug|BIBW 2992|Escalating dose cohorts
16277583|NCT00809120|Device|Neuromuscular Electrical stimulator (Cefar rehab 4 pro)|50Hz 30 min 7 sessions
16277584|NCT00809107|Drug|HCG|5000IU
16277585|NCT00809094|Drug|N-acetylcysteine (NAC)|
16277586|NCT00809094|Drug|Placebo|
16277587|NCT00809081|Procedure|Enteral Feeding and Total Parental Support|"Enteral Feeding : 20ml/hr on POD1
~Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)"
16277588|NCT00809068|Drug|fenofibrate and tibolone|fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
16277589|NCT00809068|Drug|tibolone|tibolone 2.5 mg daily 23 weeks
16277590|NCT00809055|Drug|Caffeine citrate|Caffeine to be administered as outlined to compare efficacy of different dosages.
16277591|NCT00809042|Drug|hydroxyurea|Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
16277592|NCT00809042|Drug|L-carnitine and hydroxyurea|Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). L-carnitine (Minoo, Iran, 250 mg tablets) was administered in divided doses (50mg/kg/day).
16277593|NCT00809042|Drug|hydroxyurea and magnesium chloride|Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). Magnesium chloride powder ( tabib tajhiz nik, Iran) was formulated into suspension; each ml containing 1meq magnesium chloride. It was administered in divided doses at 0.6meq/kg/day.
16277594|NCT00809042|Drug|hydroxyurea,L-carnitine and magnesium chloride|Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). L-carnitine (Minoo, Iran, 250 mg tablets) was administered in divided doses (50mg/kg/day). Magnesium chloride powder ( tabib tajhiz nik, Iran) was formulated into suspension; each ml containing 1meq magnesium chloride. It was administered in divided doses at 0.6meq/kg/day
16277595|NCT00809029|Other|GIP (glucose dependent insulinotropic peptide) infusion|an intravenous infusion of GIP (glucose dependent insulinotropic peptide)or placebo will be administered at a rate of 2 pmol/kg/min and maintained for 240 minutes.
16277596|NCT00809016|Radiation|3-dimensional conformal radiation therapy|
16277597|NCT00809016|Radiation|fludeoxyglucose F 18|
16277598|NCT00809016|Radiation|intensity-modulated radiation therapy|
16277599|NCT00808990|Dietary Supplement|BioFemale|BioFemale 6 months.
16277600|NCT00808977|Drug|Dersalazine sodium|Dersalazine sodium 2400 mg daily
16277603|NCT00808964|Drug|NU172|NU172 administered IV bolus followed by continuous infusion during CABG surgery
16277604|NCT00808951|Drug|Artesunate-amodiaquine|Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
16277605|NCT00808951|Drug|Artemether-lumefantrine|Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
16277606|NCT00808938|Device|MST|Magnetic Seizure Therapy
16277607|NCT00808925|Other|exposure to heat|Dressed in shorts and tennis shoes the subjects will be exposed to exercise-heat stress for 12 consecutive days (excluding Saturday). Daily exposure will last 120 min, under the controlled environmental conditions of 40oC and 40% relative humidity. The exercise will consist of walking on a treadmill at a pace of 5km/h and 2% incline.
16277608|NCT00808912|Drug|sildenafil|sildenafil 50 mg ingested orally 1 hour prior to exercise testing
16277609|NCT00808912|Other|placebo|matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
16277610|NCT00808899|Drug|Temsirolimus|Temsirolimus
16277611|NCT00808899|Drug|Irinotecan|Irinotecan
16277612|NCT00808899|Procedure|Surgical Resection of Primary Tumor|Surgical Resection of Primary Tumor
16277613|NCT00808899|Drug|Cyclophosphamide|Cyclophosphamide
16277614|NCT00808899|Drug|Doxorubicin|Doxorubicin
16277615|NCT00808899|Drug|Etoposide|Etoposide
16277616|NCT00808899|Drug|Cisplatin|Cisplatin
16277617|NCT00808899|Drug|Topotecan|Topotecan
16277618|NCT00808899|Procedure|PBSC|Peripheral Blood Stem Cell Harvest
16277619|NCT00808899|Radiation|Radiation Therapy|Radiation Therapy
16277620|NCT00808899|Drug|13-cis-retinoic acid|13-cis-retinoic acid
16277621|NCT00808873|Other|socio-educational intervention|brief mental health education and 6 follow-up visits
16277622|NCT00808860|Dietary Supplement|GP group|Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally
16277623|NCT00808860|Dietary Supplement|Placebo group|Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
16277624|NCT00808834|Device|Lotrafilcon A contact lens|Investigational, silicone hydrogel, spherical, soft contact lens
16277625|NCT00808834|Device|Senofilcon A contact lens|Commercially marketed, silicone hydrogel, spherical, soft contact lens
16277626|NCT00808808|Biological|Choice of TIV or FluMist with baseline advertisement|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
16277627|NCT00808808|Other|Choice of TIV or FluMist with enhanced advertisement and incentives|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
16277628|NCT00808808|Biological|Control - Usual care offering TIV only with baseline advertisement|A control arm of usual care offering TIV with baseline advertisement
16277629|NCT00808795|Drug|N-acetylcysteine|NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
16277630|NCT00808795|Drug|Placebo|Placebo of NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
16277631|NCT00808782|Device|Deep rTMS|Repetitive transcranial magnetic stimulation targeting the medial prefrontal cortices. 30 10s 5Hz rTMS trains per day, with a 20 gap between each (15 minutes total), each consecutive weekday for two weeks.
16277632|NCT00808782|Device|Sham rTMS|Sham (non-active) repetitive transcranial magnetic stimulation over the medial prefrontal cortices. 30 10s 5Hz rTMS trains per day, with a 20 gap between each (15 minutes total), each consecutive weekday for two weeks
16277633|NCT00808769|Drug|Zegerid®|capsule(20 mg omeprazole/sodium bicarbonate), single dose
16277634|NCT00808769|Drug|Prilosec OTC®|Omeprazole-magnesium 20.6 mg, tablet, single dose
16277635|NCT00808756|Dietary Supplement|Fermentable carbohydrates.|Infant formula enriched with fermentable carbohydrates.
16277636|NCT00808756|Other|Standard infant formula.|Standard infant formula.
16277637|NCT00808743|Drug|Celecoxib|Celecoxib: 400mg twice daily, orally, 6 months
16277638|NCT00808743|Drug|Ursodeoxycholic acid|"Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:
~below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses"
16277639|NCT00808743|Drug|Placebo|"Placebo: orally, 6 months, dosage based on body weight:
~below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses"
16277640|NCT00808730|Procedure|fiberoptic fibroscopy|Bronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment
16277641|NCT00808717|Drug|Atorvastatin|Atorvastatin 10 mg vs. 80 mg before intervention
16277642|NCT00808704|Drug|recombinant human erythropoietin|r-hu-EPO were administered either 300 U/kg or 500 U/kg, subcutaneously the first time and then intravenously every other day for 2 weeks.
16277643|NCT00808691|Other|Critical care|Standard care for each group of patients
16277644|NCT00808678|Drug|ABT-143|once, see arm description for more information
16277645|NCT00808678|Drug|ABT-335|once, see arm description for more information
16277646|NCT00808678|Drug|rosuvastatin|once, see arm description for more detail
16277647|NCT00808665|Drug|Dexmedetomidine|Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
16277648|NCT00808665|Drug|0.9% Saline|Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
16277716|NCT00808210|Drug|Methotrexate|Oral or parenteral repeating dose
16277649|NCT00808652|Other|Measurement of flow mediated dilation of brachial artery.|"Flow-mediated brachial artery reactivity will be measured and flow-mediated vasodilatation will be assessed with the subject's arm using a 15 MHz linear array ultrasound.
~Study Phases:
~Flow-mediated (endothelial-dependent) vasodilatation (FMD): Following a 2-minute baseline period, a longitudinal image of the artery will be obtained. A tourniquet placed around the forearm proximal to the target artery will be inflated to a pressure 50 mmHg higher than the subject's systolic blood pressure and held for 5 minutes. Cuff will be then deflated. A continuous scan will be performed at deflation, 60 and 90 seconds after cuff deflation, with frozen and Doppler measurements recorded at similar intervals to the baseline phase.
~NTG-induced (non-endothelial-dependent) vasodilatation (NTG): After vessel recovery, sublingual 375 mg of isosorbide dinitrate spray will be administered, and scanning will be performed continuously for 5 minutes thereafter."
16277650|NCT00808639|Drug|Methotrexate|intravenously 30mg/m2 over 30 minutes
16277651|NCT00808639|Drug|Doxorubicin|intravenously 30mg/ms over 15 minutes
16277652|NCT00808639|Drug|vinblastine|intravenously 3mg/m2 over 30 minutes
16277653|NCT00808639|Drug|cisplatin|intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
16277654|NCT00808639|Drug|Pegfilgrastim|Given subcutaneously 24 hours after last chemotherapy dose
16277655|NCT00808626|Drug|99mTc-rBitistatin|Intravenous administration of a single dose (10 mCi, 0.1 ug/kg body weight) of 99mTc-rBitistatin, followed by collection of scintigraphic (planar and SPECT) images at 1 hour and 2-4 hours.
16277656|NCT00808613|Device|Optetrak PS|Optetrak Posterior Stabilized total knee replacement
16277657|NCT00808613|Device|Optetrak Hi-Flex|Optetrak Hi-Flex total knee replacement
16277658|NCT00808600|Behavioral|resource-activating behavioural training programme|"Stepwise intervention based on the principles of resource-activating training (RAT) applied to the needs of patients in the process after lung transplantation.
~Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Continued resource-activation and transfer by means of internet-based interventions (1 per 2 weeks) as well as personal interventions by trained nurses and a clinical psychologist during regular out-patient visits (approx. 4 times per year) over one year immediately following rehabilitation. Interventions focus on strengthening individual and interpersonal resources for well-being, psychoeducation, stress management and coping with illness. Phase 3: Termination and transfer, including a detailed medical report."
16277659|NCT00808600|Behavioral|Relaxation training|Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Regular relaxation training after rehabilitation by self-guided relaxation compact disk and accompanying worksheets.
16277660|NCT00808600|Behavioral|Intensified anaerobic exercise training|Phase 1: Recruitment and initiation of intensified and individualised aerobic/anaerobic exercise training based on determination of aerobic/anaerobic threshold during rehabilitation in the rehabilitation centre Fallingbostel. During rehabilitation daily training sessions with a duration of 30 minutes each are performed under medical supervision. Phase 2: Home training on an IT-assisted ergometer 3.5 times a week with interval exercise intensity above the anaerobic threshold. Work load and heart rate are stored by an ergometer-chip, lung function analyses are performed and should be transferred via phone-based telemetry. Exercise training intensities will be adapted monthly, corresponding to training results. At regular 3 months visits to the outpatient clinic a medical examination is carried out. Moreover, according to the actual functional state of the patient estimated 3 monthly training work load will be adjusted. Phase 3: Termination, evaluation after a period of 12 months.
16277661|NCT00808600|Behavioral|Moderate aerobic exercise training|Phase 1: Recruitment and initiation of moderate aerobic exercise training based on 40 percent of maximal oxygen consumption in Watt during rehabilitation in the rehabilitation centre Fallingbostel. Phase 2: Moderate aerobic endurance training with the target intensity of 40 percent of the individual maximum exercise capacity will be performed 3.5 times a week with a duration of 30 minutes per session, work load will be adapted continuously according to the measures that are assessed during the repeated control examinations after periods of 3 months in the outpatient clinic of the pulmonary department of Hanover Medical School.
16277662|NCT00808574|Behavioral|Obstructive sleep apnea screening intervention|Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.
16277663|NCT00808561|Other|Group 1: Alternative Fistula|Performing other autogenous AV fistulas which include various options such as brachiocephalic AV fistula, basilic or brachial vein transpositions or a variety of other strategies to maintain a primary access. The advantage would be to maintain an autogenous all venous access with less risk of infection and thrombosis.
16277664|NCT00808561|Other|Group 2: Forearm AV Graft|a) ePTFE (polytetrafluoroethylene) bridge AV graft typically anastomosed in the proximal forearm to the radial or brachial artery and to an antecubital vein. The advantages include a quick maturation of 2-3 weeks, excellent flow rates and high technical success rates. Although secondary patency rates approach 80% at one year postoperatively, disadvantages include a more involved surgical procedure, a lower primary patency than a well functioning AV fistula, and higher revision and infection rates.4, 5
16277665|NCT00808548|Other|counseling, emotional support|
16277666|NCT00808548|Other|emotional support|emotional support during the interview
16277667|NCT00808548|Other|emotional support|emotional supporting during the interview
16277668|NCT00808535|Procedure|Cardiac Perfusion MRI w Vasomotor Stress|All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
16277669|NCT00808522|Drug|hCG|recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.
16277670|NCT00808509|Biological|adalimumab|40 mg every other week via subcutaneous injection
16277671|NCT00808509|Drug|methotrexate|At least 10 mg/week administered orally or subcutaneously
16277672|NCT00808496|Other|MRI|"Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. Scored using the Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS).
~MRI intervention group also undergoes radiography imaging. Only protocol determined smallest detectable changes on MRI reported."
16277717|NCT00808210|Drug|Methylprednisolone|Intravenous repeating dose
16277673|NCT00808496|Other|Radiography|"Biannual disease progression monitoring with radiography of both hands and wrists. Scored using the van der Heijde-modified Sharp score.
~Radiography intervention group also undergoes MRI imaging. Only protocol determined smallest detectable changes on radiography reported."
16277674|NCT00808496|Other|Standard of Care|Diagnostic imaging results (MRI or radiography) reported upon requisition. Standard of Care intervention group undergoes both MRI and radiography imaging. Upon requisition of either MRI or radiography, radiology reports are delivered as per institutional standard of care
16277675|NCT00808483|Other|Walking skill training program|12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with supervision and guidance from a physiotherapist.
16277676|NCT00808470|Drug|beta-carotene, vitamins C and E, magnesium|"6 mint-flavored tablets per day, taken once daily
~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
16277677|NCT00808470|Other|Placebo|6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal.
16277678|NCT00808444|Biological|Pneumococcal conjugate vaccine GSK1024850A (different lots)|Intramuscular injection, 3 doses
16277679|NCT00808444|Biological|Infanrix hexa|Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
16277680|NCT00808444|Biological|Infanrix-IPV/Hib|Intramuscular injection, only for Visit 2 in Singapore
16277681|NCT00808444|Biological|Rotarix|Oral, 2 doses
16277682|NCT00808431|Behavioral|Lifestyle counseling|3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion
16277683|NCT00808418|Drug|Elesclomol Sodium|Chemotherapy agent
16277684|NCT00808418|Drug|Docetaxel|Chemotherapy agent
16277685|NCT00808405|Drug|acyclovir|400mg taken orally three times daily for 5 days
16277686|NCT00808405|Drug|matching placebo|matching placebo taken orally three times daily for 5 days.
16277687|NCT00808392|Biological|Haemophilus influenzae type b vaccine|3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
16277688|NCT00808392|Biological|Commercial Haemophilus influenzae type b vaccine|3 doses one month apart of Haemophilus influenzae type b vaccine.
16277689|NCT00808379|Drug|Chemoradiation|Chemotherapy will begin on the first day of radiotherapy and continue until the completion of radiotherapy. Capecitabine will be administered orally daily 2000 mg/m2 in two divided doses (approximately 12 hours apart) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
16277690|NCT00808379|Radiation|Additional Radiation boost to the primary tumor volume|15-20Gy
16277691|NCT00808366|Drug|Keratolytic/Antifungal|Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
16277692|NCT00808366|Drug|Keratolytic/Antifungal|Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
16277693|NCT00808340|Device|balafilcon A|multifocal contact lens
16277694|NCT00808340|Device|senofilcon A production|multifocal contact lens
16277695|NCT00808340|Device|senofilcon A test|multifocal contact lens
16277696|NCT00808327|Drug|Bupivacaine|A single, 15mg, intrathecal dose of bupivacaine.
16277697|NCT00808327|Drug|Bupivacaine, fentanyl|A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl
16277698|NCT00808314|Drug|Rest/Dipyridamole Stress Rb-82 Myocardial Perfusion PET/CT|A CT scan will be acquired for attenuation correction of the rest image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding. This will be followed by infusion of approximately 60 mCi of Rb-82, 60 to 100 seconds after which resting images will be acquired with ECG-gating. Following rest imaging, 0.56 mg/kg of dipyridamole will be infused over 4 minutes. Three minutes after the completion of the infusion, approximately 60 mCi of Rb-82 will be infused. Peak stress images will be acquired with ECG-gating, starting 90 seconds after the the beginning of the infusion of Rb-82 and continuing for 5 minutes. A CT scan will be acquired for attenuation correction of the stress image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding.
16277699|NCT00808314|Drug|Rest/Lexiscan(TM) Stress Rb-82 Myocardial Perfusion PET|A CT scan will be acquired for attenuation correction of the rest image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding. This will be followed by infusion of approximately 60 mCi of Rb-82, 60 to 100 seconds after which resting images will be acquired with ECG-gating. Following rest imaging, 400 umg of Lexiscan(TM) will be injected, and then approximately 60 mCi of Rb-82 waill be infused. Peak stress images will be acquired in list mode with ECG-gating, starting 90 seconds after the the beginning of the infusion of Rb-82 and continuing for 5 minutes. A CT scan willbe acquired for attenuation correction of the stress image (9 mA, 120 kVp, 4.24 secs) during end-expiration breath-holding.
16277700|NCT00808301|Other|Gluten-free products|Gluten-free bakery products containing oatmeal.
16277701|NCT00808288|Drug|PF-00610355|oral, inhaled, dry powder, 600ug, OD
16277702|NCT00808288|Drug|PF - 00610355|oral, inhaled, dry powder, 300ug, OD
16277703|NCT00808288|Drug|PF- 00610355|oral, inhaled, dry powder, 100ug, OD
16277704|NCT00808288|Drug|Placebo|oral, inhaled, dry powder, placebo, OD
16277705|NCT00808288|Drug|Salmeterol|salmeterol, 50ug, BID
16277706|NCT00808275|Dietary Supplement|Dietary calcium|Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.
16277707|NCT00808262|Biological|TNFa Kinoid|TNFa kinoid at days 0, 7, 28
16277708|NCT00808249|Drug|AZD7325|2 tablets taken twice a day for 28 days
16277709|NCT00808249|Drug|AZD7325|2 tablets taken twice a day for 28 days
16277710|NCT00808249|Drug|AZD7325|2 tablets taken twice a day for 28 days
16277711|NCT00808249|Drug|Placebo|2 tablets taken twice a day for 28 days
16277712|NCT00808236|Device|RhinoChill|Nasal catheters are placed and cooling is begun during the resuscitation attempt
16277713|NCT00808236|Other|Control|Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines
16277714|NCT00808223|Biological|alefacept|IM injection
16277715|NCT00808210|Drug|Infliximab|Intravenous repeating dose
16277720|NCT00808197|Procedure|ocular blood flow measurement|Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry
16277721|NCT00808184|Drug|CPT-11, Raltegravir (Isentress®), Midazolam|
16277722|NCT00808171|Drug|Livopan|Inhalation of oxygen and nitrous oxide 50%
16277723|NCT00808171|Drug|Livopan|equimolar mixture of N2O/O2
16277724|NCT00808171|Drug|EMLA|Lidocaine-prilocain cream
16277725|NCT00808145|Drug|Gemcitabine / Cisplatin / Sorafenib|All patients will receive gemcitabine 1000mg/m2 cisplatin 30mg/m2 sorafenib 400mg orally twice daily
16277726|NCT00808132|Drug|bazedoxifene 20 mg/ conjugated estrogens 0.45 mg|One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
16277727|NCT00808132|Drug|bazedoxifene 20 mg/ conjugated estrogens 0.625 mg|One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
16277728|NCT00808132|Drug|bazedoxifene 20 mg|One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
16277729|NCT00808132|Drug|conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg|One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
16277730|NCT00808132|Drug|Placebo|One capsule, placebo (over-encapsulated), once a day for one year.
16277731|NCT00808119|Drug|RTI-336 (CTDP 31862)|The RTI-336 drug product is formulated as hard, white, gelatin capsules. The dosage levels are 0.3, 1.0, and 3.0 mg (Cohort 1) and 6.0, 12.0, and 20.0 mg (Cohort 2). Subjects will receive a single dose of the study drug on study day 1.
16277732|NCT00808093|Drug|GSK256073|GSK256073 100 mg study drug
16277733|NCT00808080|Biological|AMLCTL|Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
16277734|NCT00808067|Drug|dabigatran dose 1|dabigatran high dose twice daily
16277735|NCT00808067|Drug|dabigatran dose 2|dabigatran low dose twice daily
16277736|NCT00808054|Drug|EMLA|0.5g topical EMLA
16277737|NCT00808041|Device|Dedicated breast computed tomography imaging|Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.
16277738|NCT00808028|Biological|meningococcal B rLP2086 vaccine.|vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
16277739|NCT00808028|Biological|meningococcal B rLP2086 vaccine.|vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
16277740|NCT00808028|Biological|meningococcal B rLP2086 vaccine.|vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
16277741|NCT00808028|Other|normal saline (placebo)|vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
16277742|NCT00808015|Drug|varenicline|Champix will be prescribed as per usual practice and at the sole discretion of the physician
16277743|NCT00808002|Drug|Raltegravir|Raltegravir 400 mg every 12 hours
16277744|NCT00808002|Drug|Maraviroc|Maraviroc 300 mg every 12 hours
16277745|NCT00808002|Drug|Tenofovir/Emtricitabine|Tenofovir/Emtricitabine 300/200 mg every 24 hours
16277746|NCT00807989|Drug|Carbamazepine|
16277747|NCT00807989|Drug|Lamotrigine/Valproate|
16277748|NCT00807963|Drug|rHuPH20|recombinant human hyaluronidase PH20 injection
16277749|NCT00807963|Drug|zoledronic acid|subcutaneous injection
16277750|NCT00807950|Drug|Simvastatin|
16277751|NCT00807937|Drug|AZD7325|4 tablets and 1 capsule taken twice a day for 28 days
16277752|NCT00807937|Drug|AZD7325|4 tablets and 1 capsule taken twice a day for 28 days
16277753|NCT00807937|Drug|Lorazepam|4 tablets and 1 capsule taken twice a day for 28 days
16277754|NCT00807937|Drug|Placebo|4 tablets and 1 capsule taken twice a day for 28 days
16277755|NCT00807911|Drug|Adjuvant FL|5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles
16277756|NCT00807911|Drug|Adjuvant FOLFOX|oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles
16277757|NCT00807885|Drug|hylenex-facilitated subcutaneous Lactated Ringer's infusion|single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
16277758|NCT00807872|Biological|124I-labeled monoclonal antibody Mu 11-1F4|Single infusion of radiolabeled antibody: 2 mCi (1 mg)
16277759|NCT00807859|Drug|AMG 386 30 mg/kg, Paclitaxel and Trastuzumab|AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
16277760|NCT00807859|Drug|AMG 386 30 mg/kg, Capecitabine and Lapatinib|AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
16277761|NCT00807859|Drug|AMG 386 10 mgkg, Paclitaxel and Trastuzumab|AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
16277762|NCT00807859|Drug|AMG 386 10 mg/kg, Capecitabine and Lapatinib|AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
16277763|NCT00807846|Drug|Celecoxib|Celecoxib 50 mg or 100 mg PO BID for 6 weeks
16277764|NCT00807846|Drug|Naproxen|Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
16277765|NCT00807807|Dietary Supplement|Folic Acid|100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
16277766|NCT00807807|Drug|Placebo Folic Acid|Placebo folic acid once a day for 6 weeks
16277767|NCT00807794|Drug|MEDI-507|0.012 mg/kg dose given twice between 60 to 72 hours apart
16277768|NCT00807794|Drug|MEDI-507|0.06 mg/kg dose given twice between 60 to 72 hours apart
16277769|NCT00807794|Drug|MEDI-507|0.12 mg/kg dose given twice between 60 to 72 hours apart
16277770|NCT00807794|Drug|MEDI-507|0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
16277771|NCT00807794|Drug|MEDI-507|0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
16277772|NCT00807781|Biological|Mammaglobin-A DNA vaccine|
16277773|NCT00807768|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo pelvic radiation therapy
16277774|NCT00807768|Drug|Carboplatin|Given IV
16277775|NCT00807768|Radiation|Intensity-Modulated Radiation Therapy|Undergo pelvic radiation therapy
16277776|NCT00807768|Radiation|Internal Radiation Therapy|Undergo vaginal cuff brachytherapy
16277777|NCT00807768|Other|Laboratory Biomarker Analysis|Correlative studies
16277778|NCT00807768|Drug|Paclitaxel|Given IV
16277781|NCT00807755|Drug|Carboplatin|Intravenous (IV) on Day 1 of each 21-day cycle, as per dose escalation schedule (dose levels 1 and 2: dose levels 3 and 4). Number of cycles: 6 maximum.
16277782|NCT00807755|Drug|Etoposide|80mg/m2, Intravenous on Days 1, 2, 3 of a 21-day cycle (all dose levels). Number of cycles: 6 maximum.
16277783|NCT00807755|Drug|RAD001|Orally on Days 1-21 of a 21-day cycle, as per dose escalation schedule (dose level 1: 2.5 mg, dose level 2: 5 mg, dose level 3: 5.0 mg, and dose level 4: 10.0 mg). Number of cycles: unlimited (drug taken from Day 1 until progression of disease or unacceptable toxicity).
16277784|NCT00807742|Drug|Nicotine Replacement Treatment (NRT)|Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
16277785|NCT00807742|Behavioral|Brief Advice|Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
16277786|NCT00807742|Behavioral|Contingency Management|Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
16277787|NCT00807742|Behavioral|Non-Contingent Reinforcement|Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
16277788|NCT00807729|Procedure|ERCP|Endoscopic Retrograde Cholangiopancreatography Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. If choledocholithiasis was detected or suspected at the time of ERCP, a sphincterotomy was undertaken so that gallstones could be extracted using a balloon catheter or retrieval basket. Small bowel gas was aspirated endoscopically as much as possible at the conclusion of the ERCP. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP
16277789|NCT00807729|Procedure|LapCBDE|LC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed.
16277790|NCT00807716|Other|walking skill group|12 Individualized group training sessions with focus on functional exercises like walking and stair climbing including balance training under physiotherapy guidance, 12 times 70 minutes.
16277791|NCT00807716|Other|usual physiotherapy care|physiotherapy, mostly in non-weight bearing, 12 times 40 minutes
16277792|NCT00807703|Procedure|Select Stim|Select Stim: see summary
16277793|NCT00807690|Drug|Tacrolimus ointment|Tacrolimus ointment 0.1%every night for at least 3 months, half body side
16277794|NCT00807677|Drug|TAK-901|TAK-901 will be administered via IV infusion over a 3-hour period on Days 1,4,8,11,15,18,22, and 25 of each 28-day cycle.
16277795|NCT00807664|Device|Biatain Ag|Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
16277796|NCT00807664|Device|Biatain|A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked
16277797|NCT00807651|Procedure|AHSCT|All study participants given written informed consent will perform autologous hematopoietic stem cell transplantation(AHSCT) and be treated with immunosuppression.
16277798|NCT00807651|Drug|Insulin therapy|All study participants not accepted written informed consent will received insulin therapy with consistent or multiply subcutaneous injection.
16277799|NCT00807625|Drug|Depo Provera|Depo Provera administered by injection at randomization visit and the 12-week study visit.
16277800|NCT00807625|Device|Copper T Intrauterine contraception device|IUCD inserted upon randomization to this study arm
16277801|NCT00807612|Biological|AMG 479|AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1
16277802|NCT00807612|Biological|AMG 479|AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1
16277803|NCT00807612|Drug|Carboplatin|Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
16277804|NCT00807612|Biological|AMG 479|AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1
16277805|NCT00807612|Drug|Paclitaxel|Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
16277806|NCT00807599|Procedure|Stem cell transplant x 1 or x 2|"After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."
16278071|NCT00805870|Drug|Lovaza (omega-3-acid ethyl esters)|Lovaza, 3 grams per day for 65 days
16277807|NCT00807599|Drug|lenalidomide and dexamethasone|Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
16277808|NCT00807586|Drug|Solumedrol|100mg, given once within 2 hours of the end of the ablation procedure
16277809|NCT00807586|Drug|Placebo|Normal saline (1.6 cc)
16277810|NCT00807573|Drug|Paclitaxel|Day 1: Paclitaxel (90 mg/m^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m^2 over 60 minutes)
16277811|NCT00807573|Drug|Pemetrexed|Day 1: Pemetrexed (500 mg/m^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes)
16277812|NCT00807573|Drug|Bevacizumab|Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)
16277813|NCT00807560|Behavioral|FBT-PO|The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.
16277814|NCT00807560|Behavioral|NEC|Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
16277815|NCT00807547|Biological|Allergy vaccination (Alutard SQ)|Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
16277816|NCT00807534|Drug|ipratropium bromide|ipratropium bromide nebulization
16277817|NCT00807534|Drug|placebo|placebo nebulization
16277818|NCT00807534|Behavioral|constant rate step test|nebulization of 500ug
16277819|NCT00807534|Behavioral|constant rate shuttle walk test|nebulization of 500ug
16277820|NCT00807521|Drug|Dexamethasone|Single high dose bolus of dexamethasone before surgery
16277821|NCT00807521|Drug|Placebo|Placebo for dexamethasone
16277822|NCT00807508|Dietary Supplement|placebo|wheat meal capsules with each main meal
16277823|NCT00807508|Dietary Supplement|leucine|daily leucine capsules with each main meal
16277824|NCT00807495|Drug|Alisertib|Alisertib capsules
16277825|NCT00807456|Device|ASTRA TECH Implant System, OsseoSpeed™|ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
16277826|NCT00807443|Drug|Raltegravir|Raltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp & Dohme. A dose of 400 mg will be administered every 12 hours
16277827|NCT00807430|Device|Grindcare (Active)|Active treatment
16277828|NCT00807430|Device|Grindcare (Placebo - the device is not activated)|Placebo treatment
16277829|NCT00807404|Procedure|histopathologic examination|
16277830|NCT00807404|Procedure|optical coherence tomography|
16277831|NCT00807391|Procedure|TBCA, TBNA|One arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist.
16277832|NCT00807378|Other|LUMBAR PUNCTURE|LUMBAR PUNCTURE FFOR CSF COLLECTION
16277833|NCT00807365|Drug|GHRH|GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months.
16277834|NCT00807339|Radiation|Stereotactic radiation|Dose escalation three consecutive treatments
16277835|NCT00807339|Device|CyberKnife Robotic Radiosurgery System|
16277836|NCT00807326|Drug|Loperamide/simeticone 2 mg/125 mg caplets|Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)
16277837|NCT00807326|Drug|Loperamide/simeticone 2 mg/125 mg chewable tablets|Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)
16277838|NCT00807326|Drug|Probiotic Saccharomyces boulardii 250 mg capsules|Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)
16277839|NCT00807300|Radiation|CT-guided brachytherapy|catheter placed into the tumor by CT-guidance, radiation with iridium 192
16277840|NCT00807300|Procedure|transarterial chemoembolization|application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
16277841|NCT00807287|Procedure|Jejunal tube placement using the unguided frictional method|The self-advancing nasal jejunal feeding tube has small alternating cilia-like plastic flaps to help to advance it into the small bowel via peristalsis. The tube is placed in the stomach (50-60 cm mark). Then the tube is left in place for 1 hour to allow the patient's peristalsis to advance the tube by catching its small plastic tabs. Thereafter, the tube is manually advanced 10 cm every hour until the 100 cm mark of length is reached. To improve peristalsis, 10mg metoclopramide i.v. and 200mg erythromycin i.v. 15 minutes before the procedure are administered.
16277842|NCT00807287|Procedure|Jejunal tube placement using the endoscopic method|Jejunal feeding tubes are placed using endoscopy
16277843|NCT00807261|Drug|Gemcitabine and Docetaxel|"Drug and schedule
~Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8)
~Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days
~Dose modification
~Treatment should be delayed if the ANC<1,500/ mm3, or if the platelet count <75,000/mm3 on the first day of the next cycle.
~Gemcitabine & docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy.
~Patients with response or no change will receive 2 additional cycles."
16277844|NCT00807248|Drug|Escitalopram placebo|Once daily before bedtime for 8 weeks
16277845|NCT00807248|Drug|Gaboxadol placebo|Once daily before bedtime for 8 weeks
16277846|NCT00807248|Drug|Escitalopram 20 mg|Once daily before bedtime for 8 weeks
16277847|NCT00807248|Drug|Gaboxadol 5 mg|Once daily before bedtime for 8 weeks
16277848|NCT00807248|Drug|Gaboxadol 10 mg|Once daily before bedtime for 8 weeks
16277849|NCT00807235|Drug|Aerosolized lucinactant|Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.
16278072|NCT00805870|Drug|Wheat Germ Oil|Wheat germ oil, 3 grams/day for 65 days
16277850|NCT00807235|Drug|Aerosolized lucinactant|Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.
16277851|NCT00807222|Drug|lisdexamfetamine dimesylate|Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
16277852|NCT00807209|Drug|Low Dose SKY0402|Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
16277853|NCT00807209|Drug|High Dose SKY0402|Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
16277854|NCT00807209|Drug|Placebo|Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)
16277855|NCT00807209|Drug|Fentanyl via PCA|Fentanyl via PCA
16277856|NCT00807209|Drug|Bupivacaine via epidural|Bupivacaine via epidural
16277857|NCT00807196|Drug|Rituximab|250mg/m2 day -21 and day -14 of preparative regimen
16277858|NCT00807196|Drug|90Y ibritumomab tiuxetan (Zevalin)|0.4 mCi/kg IV on day -14 of preparative regimen
16277859|NCT00807196|Drug|Cyclophosphamide|300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
16277860|NCT00807196|Drug|Fludarabine|30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
16277861|NCT00807196|Other|Non myeloablative allogeneic stem cell transplantation|Blood stem cell infusion on day 0
16277862|NCT00807183|Other|woodstove|installation of new EPA-certified woodstove
16277863|NCT00807183|Other|inactive air filter|air filter units without filter in place
16277864|NCT00807183|Other|Active air filter|air filter units correctly operating
16277865|NCT00807170|Drug|ZD6474 (Vandetanib)|100 mg as a once daily oral dose, 21 days
16277866|NCT00807170|Radiation|Whole Brain Radiotherapy (WBRT)|
16277867|NCT00807170|Drug|ZD6474|200 mg as a once daily oral dose, 21 days
16277868|NCT00807170|Drug|ZD6474|300 mg as a once daily oral dose, 21 days
16277869|NCT00807157|Dietary Supplement|PROBIOSTICK® during 30 days|Every morning subjects will consume a stick of PROBIOSTICK® during 30 days
16277870|NCT00807157|Dietary Supplement|Placebo during 30 days|Every morning subjects will consume a stick of placebo during 30 days
16277871|NCT00807144|Drug|Tacrolimus (Kidney transplant maintenance immunosuppression)|Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
16277872|NCT00807144|Drug|Kidney transplant maintenance immunosuppression|Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
16277873|NCT00807131|Behavioral|Patient follow-up|Dader method, which was developed to provide pharmaceutical care, which consists of seven steps covering the evaluation of services, benefits of interventions, and identification of unexpected occurrences. Its objectives are to improve the patient quality of life.
16277874|NCT00807131|Behavioral|Counseling|The pharmacist proceeds the counseling when the patient comes to the pharmacy to take their medicines.
16277875|NCT00807131|Behavioral|Drug dispensing|The pharmacist gives the drugs to the patient with the minimum of information necessary to guarantee a safe and effective drug intake.
16277876|NCT00807131|Behavioral|pharmacy usual care|The patient receives no information about their medicines in the pharmacy, unless he asks for it.
16277877|NCT00807118|Drug|Fesoterodine|Single dose of 2 x 4 mg tab in formulation F under fed condition
16277878|NCT00807118|Drug|Fesoterodine|Single dose of 1 x 8 mg tab in formulation F under fed condition
16277879|NCT00807118|Drug|Fesoterodine|Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
16277880|NCT00807118|Drug|Fesoterodine|Single dose of 1 x 8 mg tab in formulation F under fed condition
16277881|NCT00807118|Drug|Fesoterodine|Single dose of 2 x 4 mg tab in formulation F under fasted condition
16277882|NCT00807118|Drug|Fesoterodine|Single dose of 1 x 8 mg tab in formulation F under fasted condition
16277883|NCT00807105|Device|H-coil dTMS|treatment with deep TMS stimulation.
16277884|NCT00807092|Drug|biphasic insulin aspart 30|The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner
16277885|NCT00807092|Drug|biphasic human insulin 30|The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner
16277886|NCT00807092|Drug|metformin|Metformin dose must remain the same as that used prior to the trial.
16277887|NCT00807079|Drug|carboplatin|
16277888|NCT00807079|Drug|topotecan hydrochloride|
16277889|NCT00807066|Drug|Gefitinib|Gefitinib 250 mg/day
16277890|NCT00807066|Drug|Platinum|Platinum based chemotherapy with cycles every 21 days
16277891|NCT00807053|Drug|Ciclesonide HFA|75 mcg Ciclesonide HFA versus Placebo
16277892|NCT00807053|Drug|Ciclesonide HFA|150 mcg Ciclesonide HFA versus Placebo
16277893|NCT00807053|Drug|Ciclesonide HFA|300 mcg Ciclesonide HFA versus Placebo
16277894|NCT00807053|Drug|Placebo|Placebo
16277895|NCT00807040|Procedure|Mitral Valve Repair with Annuloplasty|The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
16277896|NCT00807040|Procedure|Mitral Valve Replacement|Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
16277897|NCT00807027|Drug|Activated T lymphocyte(Immuncell-LC)|"Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
~Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)"
16277898|NCT00807014|Drug|Duac Gel|Duac® Gel will be applied to the face once daily at night, for 12 weeks.
16278073|NCT00805857|Drug|Tipranavir|
16277899|NCT00807014|Drug|Differin gel|Differin Gel will be applied to the face once daily at night, for 12 weeks.
16277900|NCT00807001|Drug|IDX184|oral dose, active or placebo
16277901|NCT00806988|Procedure|Mitral Valve Repair|"Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
~The heart will be arrested with cardioplegia.
~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings."
16277902|NCT00806988|Procedure|CABG|CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
16277903|NCT00806975|Device|KwikPen® and FlexPen®|The treatment is changed to twice a day injection of the same unit of Novo Rapid 30 Mix injection FlexPen® or Humalog Mix 25 injection KwikPen®for 3 months, after which the final assessment is made.
16277904|NCT00806962|Drug|Adjuvant/Excipients|intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart
16277905|NCT00806962|Device|placebo|intranasal, puff of air, 2 doses, 21 days apart
16277906|NCT00806962|Biological|Norwalk VLP Vaccine|intranasal, 50mcg, 2 doses--21 days apart
16277907|NCT00806962|Biological|Norwalk VLP Vaccine|Intranasal, 100 mcg, 2 doses, 21 days apart
16277908|NCT00806936|Drug|human insulin|Any kind of human insulin administered at the discretion of the physician
16277909|NCT00806936|Drug|insulin analogue|Any kind of insulin analogue administered at the discretion of the physician
16277910|NCT00806923|Drug|Cisplatin|80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
16277911|NCT00806923|Drug|Gemcitabine|1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
16277912|NCT00806923|Drug|Placebo|iv on day 1 of each 3 week cycle until disease progression
16277913|NCT00806923|Drug|bevacizumab [Avastin]|15mg/kg 1v on day 1 of each 3 week cycle until disease progression
16277914|NCT00806923|Drug|bevacizumab [Avastin]|7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
16277915|NCT00806910|Drug|Conivaptan|IV Vaprisol initially at 20 mg IV injection over 30 minutes, followed by a 20 mg IV infusion over the next 24 hours (i.e. 20 mg bolus, 20 mg continuous infusion approximately 24 hrs).
16277916|NCT00806910|Other|Placebo|Placebo (will be given at the same rate of Vaprisol given in the treatment arm)
16277917|NCT00806897|Drug|insulin detemir|Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
16277918|NCT00806884|Other|Physiotherapy Musculoskeletal Treatment|Other: Physiotherapy Musculoskeletal Treatment Specific, gentle oscillatory mobilisations to the rib cage and thoracic spine of the subjects to improve joint alignment and mobility, and to reduce pain. Treatment of specific muscle dysfunction or tight muscle groups to further optimise muscle length and biomechanical relationships in the area , leading to improved efficiency of recruitment and improved power output. Postural education and awareness discussions to improve the subject's own joint alignment and ability in a functional manner. A short programme to reinforce the progress during the treatment sessions may be given.
16277919|NCT00806884|Other|Control group measurements|None other than control group measurements
16277920|NCT00806871|Drug|Methylprednisolone 40 mg|"Depo-medrol 40 mg , suspension, injection in the carpal tunnel, one time use
~1 ml 40 mg Methylprednisolone + 1 ml 10mg Lidocaine + 1 ml saline"
16277921|NCT00806871|Drug|Methylprednisolone 80 mg|"Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use.
~2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine"
16277922|NCT00806871|Drug|Sodium chloride|"Saline solution 0,9%, injection in the carpal tunnel, one time use
~1 ml 10 mg Lidocaine + 2 ml saline"
16277923|NCT00806858|Device|NovoPen® 4|Insulin administration by means of a NovoPen® 4 pen device
16277924|NCT00806819|Drug|Nintedanib (BIBF1120)|starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
16277925|NCT00806819|Drug|Pemetrexed|500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
16277926|NCT00806819|Drug|pemetrexed|500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
16277927|NCT00806819|Drug|B12|1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
16277928|NCT00806819|Drug|dexamethasone (or corticosteroid equivalent)|4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
16277929|NCT00806819|Drug|placebo|starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
16277930|NCT00806819|Drug|dexamethasone (or corticosteroid equivalent)|4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
16277931|NCT00806819|Drug|B12|1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
16277932|NCT00806819|Drug|Folic Acid|400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
16277933|NCT00806819|Drug|B12|1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
16277934|NCT00806819|Drug|dexamethasone (or corticosteroid equivalent)|4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
16277935|NCT00806819|Drug|Folic Acid|400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
16277936|NCT00806819|Drug|placebo|starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
16277937|NCT00806819|Drug|Folic Acid|400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
16277938|NCT00806819|Drug|Nintedanib (BIBF1120)|starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
16277939|NCT00806819|Drug|Pemetrexed|500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
16277940|NCT00806806|Drug|SKY0402|Local administration of SKY0402 followed by noxious stimulus
16277941|NCT00806806|Drug|Placebo|Local administration of Placebo followed by noxious stimuli
16277942|NCT00806780|Procedure|on table cholangiography|x-ray imaging of common bile duct
16277943|NCT00806767|Biological|therapeutic immune globulin|
16277944|NCT00806767|Drug|busulfan|
16277945|NCT00806767|Drug|fludarabine phosphate|
16277946|NCT00806767|Procedure|allogeneic hematopoietic stem cell transplantation|
16277947|NCT00806754|Drug|Ciclesonide nasal spray + placebo Azelastine|Ciclesonide nasal spray 50 mcg + Placebo Azelastine
16277948|NCT00806754|Drug|Ciclesonide nasal spray + Azelastine|Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg
16277949|NCT00806741|Drug|NG-monomethyl-L-arginine (L-NMMA)|bolus 6mg/kg over 5 minutes followed by a continuous infusion of 60µg/kg/min over 15 minutes
16277950|NCT00806741|Drug|Phenylephrine|1μg/kg/min, infusion period 20 minutes
16277951|NCT00806741|Drug|Physiological saline solution (as placebo)|infusion period 20 minutes
16277952|NCT00806741|Device|Laser Doppler Flowmetry|blood flow measurements at the temporal neuroretinal rim of the optic nerve head
16277953|NCT00806741|Device|Goldmann applanation tonometer|intraocular pressure measurements
16277954|NCT00806741|Other|squatting|Subjects will perform squatting for 6 minutes while blood flow is measured
16277955|NCT00806728|Drug|MEDI-507|0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
16277956|NCT00806728|Drug|MEDI-507|0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.
16277957|NCT00806689|Procedure|Cardiac rhythm monitor implantation|post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
16277958|NCT00806689|Device|Reveal® XT 9525|During cardiac surgery after stand alone or concomitant ablation procedure, an insertable loop recorder will be implanted subcutaneously in left pectoral region. After surgery, patients will be monitored regularly in a quarterly basis by performing telemetry of the device in the outpatient clinic. Furthermore, home telemetry will be performed once a month for optimal heart rhythm observation.
16277959|NCT00806676|Drug|Gardasil® Vaccine (FDA-approved vaccination regimen)|Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.
16277960|NCT00806663|Drug|sunitinib added to FOLFIRI|sunitinib 37 mg once daily (4 weeks on/2 weeks off)
16277961|NCT00806650|Genetic|gene expression analysis|Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
16277962|NCT00806650|Genetic|protein expression analysis|Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
16277963|NCT00806650|Diagnostic Test|diagnostic laboratory biomarker analysis|Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
16277964|NCT00806650|Other|immunoenzyme technique|Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
16277965|NCT00806650|Other|immunohistochemistry staining method|Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
16277966|NCT00806637|Procedure|Vessel sealing system uvulopalatoplasty (VSSU)|Vessel sealing system uvulopalatoplasty (VSSU) is a new technique for uvulopalatoplasty using a special biclamp forceps for better hemostasis control. Vessel sealing system (VSS) is a bipolar vascular sealing system, with integrated active feedback control. The tissue is grasped and compressed by the handpiece. After the instrument is removed, the seal is visible as a semitransparent window, which can safely be divided. Uvular tip is grasped with an Allis clamp and retracted back toward the soft palate. Excision of the uvula and the redundant part of soft palate is performed by the VSS handpiece. VSS is also used for hemostasis.
16277967|NCT00806637|Procedure|Uvulopalatal flap (UPF)|Uvulopalatal flap (UPF) is a standard uvulopalatoplasty technique. Uvulopalatal flap is usually performed as described originally by Powell et al. The soft palate was injected with 5 to 10 milliliters of 1% lidocaine with epinephrine solution. The mucosa, submucosa with glands, and fat on the lingual surface of the uvula and soft palate were removed with a scalpel. Bleeding was controlled with bipolar electrocoagulation. The uvular tip was amputated, and reflected back toward the soft palate, and fixated into its new position with multiple sutures of 3-0 chromic catgut.
16277968|NCT00806624|Drug|DU-176b tablets|DU-176b tablets taken once daily for up to 3 months
16277969|NCT00806624|Drug|DU-176b tablets|DU-176b tablets taken once daily for up to 3 months
16277970|NCT00806624|Drug|Warfarin tablets|Warfarin tablets taken once daily for up to 3 months
16277971|NCT00806611|Procedure|Alcohol Block|Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
16277972|NCT00806598|Drug|Thymoglobulin|"3.5 or 2.5 mg/kg/day IV for 5 days
~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days
~MDS patients <55 years receive 3.5 mg/kg/day for 5 days
~MDS patients >55 years receive 2.5 mg/kg/day for 5 days"
16277973|NCT00806598|Drug|Cyclosporine|5 mg/kg orally for 6 months; start after completing thymoglobulin.
16277974|NCT00806598|Drug|Methylprednisolone|1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.
16277975|NCT00806598|Drug|G-CSF|5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
16277976|NCT00806585|Drug|MK-0736|
16277977|NCT00806585|Drug|Comparator: Placebo|
16277978|NCT00806585|Drug|Comparator: HCTZ|
16277979|NCT00806572|Drug|hOKT3gamma1(Ala-Ala)|3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)
16278074|NCT00805831|Device|HDH|sutureless vascular anastomosis
16277980|NCT00806559|Other|Re-designed room|In the redesigned room patients and clinicians are sitting at a single table in a different configuration compared to the usual clinical exam room, with the doctor at the computer and two chairs for the patient and family/friends.
16277981|NCT00806559|Other|Control room|This is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family.
16277982|NCT00806546|Drug|NP101|NP101 study patch four hour application
16277983|NCT00806533|Drug|HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)|solution for intravenous infusion applied according to SmPC
16277984|NCT00806507|Procedure|Echocardiograms|Additional views performed in 5-10 minutes of regularly scheduled echocardiograms.
16277985|NCT00806507|Procedure|Blood Test|Measuring of hormones and metabolic proteins (such as sugars and acids).
16277986|NCT00806494|Drug|Fesoterodine|Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated
16277987|NCT00806481|Drug|Sevelamer carbonate|Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
16277988|NCT00806481|Drug|Placebo|Treatment group: treatment with tablets of placebo three times daily for 36 weeks
16277989|NCT00806468|Drug|Desmotabs|Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week
16277990|NCT00806442|Drug|Borage Seed Oil and Echium Seed Oil|2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.
16277991|NCT00806442|Dietary Supplement|Corn Oil|9 g/day of corn oil
16277992|NCT00806429|Procedure|transvaginal appendectomy|patient undergoes transvaginal appendectomy
16277993|NCT00806416|Drug|alendronate sodium (+) cholecalciferol|A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
16277994|NCT00806416|Drug|Comparator: alendronate|A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
16277995|NCT00806416|Dietary Supplement|Comparator: cholecalciferol (Vitamin D)|A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
16277996|NCT00806403|Drug|reteplase 10+10 U|comparison to primary PCI
16277997|NCT00806403|Procedure|primary PCI|comparison to thrombolysis
16277998|NCT00806390|Drug|Metoprolol|Metroprolol tartrate titrated up
16277999|NCT00806351|Drug|Active Anidulafungin|Subjects in this arm will receive active anidulafungin and placebo caspofungin
16278000|NCT00806351|Drug|Active Caspofungin|Subjects in this arm will receive active caspofungin and placebo anidulafungin
16278001|NCT00806338|Drug|Trodusquemine (MSI-1436)|A single dose of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3.
16278002|NCT00806338|Drug|Placebo|
16278003|NCT00806299|Drug|Loperamide / Red Grapefruit Juice|Fixed sequence of loperamide 4 mg with and without red grapefruit juice
16278004|NCT00806299|Drug|Loperamide/ White Grapefruit Juice|Fixed sequence of loperamide 4 mg with and without white grapefruit juice
16278005|NCT00806299|Drug|Loperamide / Pink Grapefruit Juice|Fixed sequence of loperamide 4 mg with and without pink grapefruit juice
16278006|NCT00806286|Drug|CS7017 tablets|CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months
16278007|NCT00806286|Drug|Paclitaxel|Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks
16278008|NCT00806286|Drug|Carboplatin|IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
16278009|NCT00806286|Drug|Placebo Tablets|Placebo tablets matching CS-7017 tablets
16278010|NCT00806273|Device|Vista Ultrasonic Bleach Bypass System|The ultrasonic needle will be activated by depressing the foot pedal which will begin the debridement process. Irrigants will be delivered constantly at the recommended rate via the syringe pump and the needle tip will be moved up and down with a 2mm amplitude for the entire 1 minute activation cycle, which will deliver a total of 3ml of irrigant. The ultrasonic unit will be turned off and the needle will be withdrawn from the canal.
16278011|NCT00806273|Device|Needle Irrigation|irrigation with 3ml 6% NaOCl is performed moving the needle from just short of binding to 2mm coronal in constant motion for 60 seconds and left untouched in a full canal for 60 seconds.
16278012|NCT00806260|Drug|VI-0521|Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
16278013|NCT00806260|Drug|Placebo|Placebo daily for 4 weeks
16278014|NCT00806260|Other|Alcohol|
16278015|NCT00806260|Other|alcohol placebo|fruit juice
16278016|NCT00806247|Drug|tapentadol HCl|
16278017|NCT00806234|Drug|Aripiprazole or Perphenazine|Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels.
16278018|NCT00806234|Drug|Metformin|Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere.
16278019|NCT00806234|Drug|Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine|Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated
16278020|NCT00806221|Drug|emollient (Cetaphil cream)|Cetaphil cream applied daily from birth
16278021|NCT00806208|Drug|MEDI-507|0.012 mg/kg MEDI 507 and Methylprednisolone
16278022|NCT00806208|Drug|MEDI-507|0.04 mg/kg MEDI 507 and Methylprednisolone
16278023|NCT00806208|Drug|MEDI-507|0.12 mg/kg MEDI 507 and Methylprednisolone
16278024|NCT00806208|Drug|MEDI-507|0.4 mg/kg MEDI 507 and Methylprednisolone
16278025|NCT00806208|Other|Placebo|Placebo IV (alternative) study days 0, 3,6, and 9
16278026|NCT00806195|Biological|MenACWY-CRM197|Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
16278196|NCT00804895|Drug|ALTIM, cortivazol injections|ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
16278027|NCT00806195|Biological|DTaP (Diptheria, Tetanus, Pertussis) Vaccine|Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
16278028|NCT00806195|Biological|Hib (Haemophilus influenza b) Vaccine|Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
16278029|NCT00806195|Biological|IPV (Inactivated Polio Vaccine) Vaccine|Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
16278030|NCT00806195|Biological|Pneumococcal conjugate Vaccine|Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
16278031|NCT00806195|Biological|MMR (Measles, Mumps, and Rubella) Vaccine|One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
16278032|NCT00806195|Biological|Varicella Vaccine|One vaccination of Varicella vaccine was administered at 12 months of age.
16278033|NCT00806195|Biological|Hepatitis A Virus|One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
16278034|NCT00806169|Drug|triamcinolone and bevacizumab|
16278035|NCT00806156|Drug|NKTR-102 q14d|NKTR-102 given on a q14 day schedule
16278036|NCT00806156|Drug|NKTR-102 q21d|NKTR-102 given on a q21 day schedule
16278037|NCT00806143|Device|repetitive transcranial stimulation (rTMS)|"Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils.
~In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days."
16278038|NCT00806143|Device|unilateral stimulation|Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation
16278039|NCT00806117|Radiation|Radiotherapy (RT)|"External irradiation 50Gy/5 weeks
~Lateral: 2 cm lateral to the bony margin of the pelvis
~Superior: Between L5 and S1
~Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)"
16278040|NCT00806117|Other|Concurrent chemoirradiation (CCRT)|Cisplatin 40mg/m2 every week during external irradiation
16278041|NCT00806117|Other|Sequence chemotherapy and radiotherapy (SCRT)|Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2
16278042|NCT00806104|Dietary Supplement|Fructo-oligosaccharides|Dietary supplementation for 4 weeks
16278043|NCT00806104|Dietary Supplement|Maltodextrins|Dietary supplementation for 4 weeks
16278044|NCT00806078|Drug|quinine sulfate|2 x 324 mg capsules (648 mg)
16278045|NCT00806078|Drug|quinine sulfate|2 x 324 mg capsules (648 mg)
16278046|NCT00806065|Drug|ENMD-2076|Oral capsules, once daily in 28-day cycles
16278047|NCT00806039|Other|Early Renal Involvement|Renal Consultation
16278048|NCT00806026|Drug|placebo and pregabalin|following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
16278049|NCT00806026|Drug|pramipexol|following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
16278050|NCT00806026|Drug|pramipexol|following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
16278051|NCT00806026|Drug|Pregabalin|pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
16278052|NCT00806026|Drug|pramipexol|pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
16278053|NCT00806026|Drug|pramipexol|pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
16278054|NCT00805974|Biological|Biological examinations (blood and urinary).|
16278055|NCT00805961|Radiation|Radiation therapy|Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks
16278056|NCT00805961|Drug|Temozolomide|Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy
16278057|NCT00805961|Drug|Bevacizumab|Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy
16278058|NCT00805961|Drug|Bevacizumab|Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11
16278059|NCT00805961|Drug|Everolimus|Everolimus 10mg by mouth daily, beginning Week 11
16278060|NCT00805948|Device|Talent Thoracic Stent Graft System|endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.
16278061|NCT00805935|Drug|Menotropin|225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
16278062|NCT00805935|Drug|Progesterone vaginal insert|100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
16278063|NCT00805935|Drug|Follitropin beta|225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
16278064|NCT00805935|Drug|Progesterone in oil|50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
16278065|NCT00805935|Drug|leuprolide acetate|Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
16278066|NCT00805922|Other|No treatment given|Capillary or venous blood will be drawn for analysing HbA1c.
16278067|NCT00805909|Drug|NI-0401|5 daily infusions with escalating doses of NI-0401
16278068|NCT00805896|Drug|Songyou|4g/pack
16278069|NCT00805896|Drug|placebo|4g/pack
16278070|NCT00805883|Procedure|Focal Phothtermal Ablation|Under general anasthesia and in Lithotomy position 2-4 14 Fr laser fibers will be placed into the prostate using 3D US guidance.
16278075|NCT00805818|Drug|NNZ-2566|"Solution for intravenous infusion.
~20 mg/kg intravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion of 1, 3, or 6 mg/kg/h for a total of 72 consecutive hours."
16278076|NCT00805818|Drug|Placebo|Sodium Chloride 0.9% Injection
16278077|NCT00805805|Drug|Tetrathiomolybdate|120 mg/day, divided as 20 mg three times/day with meals and 60 mg away from food at bedtime, for one week to test gastric tolerance. Increased to 180 mg/day, divided as 40 mg three times/day with meals and 60 mg away from food at bedtime. Serum ceruloplasmin levels measured weekly will be used as a surrogate measure of copper status, with a target of 10-15 mg/dl (normal 20-40). When target Cp levels are reached, usually in 4-8 weeks, a maintenance dose of usually 40-80 mg of TM/day, divided half with a major meal, and half away from food at bedtime will be established (vary from 10 mg to 120 mg/day).
16278078|NCT00805805|Other|Placebo|Arm 2 will basically mirror Arm 1 with the patients receiving 120 mg/day, divided as 20 mg three times/day with meals and 60 mg away from food at bedtime the first week. Increased to 180 mg/day, divided as 40 mg three times/day with meals and 60 mg away from food at bedtime. With the dosage being reduced at about the same frequency as the patients receiving TM
16278079|NCT00805792|Drug|Donepezil|Study participants will be treated with donepezil orally at an initial dose of 5 mg daily for the first 4 weeks, then increased at their 30-day visit by 5 mg to a maximum dose of 10 mg daily, if tolerated. If the participant does not tolerate the 10 mg dose, they will remain on 5 mg through the course of the study.
16278080|NCT00805779|Device|MagPro R30|Study treatments will be administered by a commercially available MagPro R30, with a cooled figure eight coil. The figure eight coil is placed directly over the posterior tibial nerve and the MagPro R30 will be activated. The coil will stimulate the posterior tibial nerve at 20 pulses per second for a 30 minute session.
16278081|NCT00805766|Drug|TA-650|(1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.
16278082|NCT00805753|Drug|ACTH|comparison of different dosages of drug
16278083|NCT00805740|Drug|Active anidulafungin|Subjects in this arm will receive active anidulafungin and placebo caspofungin
16278084|NCT00805740|Drug|Active Caspofungin|Subjects in this arm will receive active caspofungin and placebo anidulafungin
16278085|NCT00805701|Drug|avodart|0.5 avodart once daily for 13 weeks
16278086|NCT00805701|Drug|Placebo|placebo
16278087|NCT00805688|Behavioral|Questionnaires|Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)
16278088|NCT00805688|Procedure|Blood Draws|Blood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts.
16278089|NCT00805688|Device|Pedometer|Worn daily to measure physical activity.
16278090|NCT00805675|Drug|Telbivudine|600 mg monotherapy supplied in film-coated tablets.
16278091|NCT00805675|Drug|Tenofovir|Tenofovir disoproxil fumarate was supplied in 300 mg tablets
16278092|NCT00805675|Drug|Telbivudine plus tenofovir|Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or without food.
16278093|NCT00805662|Drug|oxytocin, placebo|intranasal oxytocin during intrauterine insemination
16278094|NCT00805649|Procedure|Low fluorescence Photodynamic therapy|42 J/cm2 for 72 sec
16278095|NCT00805649|Procedure|core pars plana vitrectomy|24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy
16278096|NCT00805649|Drug|dexamethasone|intravitreal injection of 0.8 mg dexamethasone
16278097|NCT00805649|Drug|bevacizumab|intravitreal injection of 1.25 mg bevacizumab
16278098|NCT00805649|Procedure|core pars plana vitrectomy|0.4 mL core pars plana vitrectomy
16278099|NCT00805649|Drug|triamcincolone|intravitreal injection of 8 mg triamcincolone
16278100|NCT00805636|Drug|2-(5-fluoro-pentyl)-2-methyl-malonic-acid ([18F]-ML-10)|[18F]-ML-10 will be radiolabeled at the PET Radioactive Drug Production (RDP) facility at or in close proximity to each clinical site, and will be administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The dose concentration selected for [18F]-ML-10 will be 7 MBq/Kg or 0.19 mCi/Kg. The radioactivity dosage of [18F]-ML-10 administered at each PET/CT session will be at least 300 MBq (8.1 mCi) and not more than 500 MBq (13.5 mCi).
16278101|NCT00805636|Radiation|Stereotactic Radio-Surgery (SRS) therapy|SRS will be administered according to the standard of care using a radiation dose of 14-24 Gy to each lesion.
16278102|NCT00805636|Procedure|Positron Emission Tomography|Each patient will undergo 2 PET/CT sessions, each following intravenous administration of [18F]-ML-10, to assess tracer uptake by the brain metastases treated by SRS. The PET/CT scan will be directed to the brain and will include one bed position. The PET/CT sessions will be performed at baseline, i.e., before the radiation treatment, and on the day after, within 24h after SRS treatment.
16278103|NCT00805623|Dietary Supplement|sucrose|1 cc of sucrose 33.5% with or without pacifier
16278104|NCT00805610|Biological|Hepatocyte Transplantation|Briefly, prepared hepatocytes from a single donor will be transplanted into the liver via intraportal or intrasplenic routes.
16278105|NCT00805597|Radiation|radiation|radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
16278106|NCT00805597|Radiation|no radiation|no radiotherapy
16278107|NCT00805584|Drug|desloratadine|Aerius (desloratadine) tablets; 5mg orally once a day in the morning for 15 days
16278108|NCT00805558|Drug|moxifloxacin|400 mg moxifloxacin once daily for 7 days
16278109|NCT00805558|Drug|Ciprofloxacin plus metronidazole|Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days
16278110|NCT00805545|Drug|Antibiotic|Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
16278111|NCT00805545|Drug|Antibiotic|Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
16278150|NCT00805207|Drug|Progesterone|Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.
16278112|NCT00805532|Behavioral|Behavioral Activation treatment|Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
16278113|NCT00805532|Other|Treatment as Usual|Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
16278114|NCT00805519|Drug|Glucosamine and chondroitin sulfate|In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
16278115|NCT00805519|Drug|glucosamine and chondroitin sulfate plus Prednisolone|In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day
16278116|NCT00805519|Drug|Glucosamine and Chondroitin sulfate plus Chloroquine|In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.
16278117|NCT00805519|Drug|Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine|In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.
16278118|NCT00805493|Drug|Riluzole|
16278119|NCT00805480|Drug|AIN457|AIN457 was administered intravenously.
16278120|NCT00805480|Drug|Placebo|Matching placebo to AIN457 was administered intravenously.
16278121|NCT00805467|Drug|Fostamatinib Disodium (R935788)|50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
16278122|NCT00805454|Drug|OPC-34712|Single oral dose, 0.5 to 25 mg
16278123|NCT00805441|Drug|LY686017|50 milligrams (mg) daily by oral route for 12 weeks
16278124|NCT00805441|Drug|Placebo|Daily by oral route for 12 weeks
16278125|NCT00805415|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg
16278126|NCT00805415|Drug|EV/DNG (SH T00658L)|Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg
16278127|NCT00805402|Other|flow cytometry|flow cytometry
16278128|NCT00805389|Biological|Engerix-B™|2 doses intramuscular injections
16278129|NCT00805389|Biological|Fendrix™|2 doses intramuscular injections
16278130|NCT00805389|Biological|GSK Biologicals' Hepatitis B vaccines (GSK223192A)|2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
16278131|NCT00805389|Biological|HBsAg (Booster injection)|Single dose intramuscular injection
16278132|NCT00805376|Drug|DNX-2401|Surgical procedure precisely injects DNX-2401 through a catheter (small tube) into brain tumor.
16278133|NCT00805376|Procedure|Tumor Removal|Surgical Tumor Resection
16278134|NCT00805350|Drug|Eplivanserin|one 5 mg tablet once a day
16278135|NCT00805350|Drug|Placebo|Placebo of Eplivanserin one tablet once a day
16278136|NCT00805337|Device|Intrabuccally-administered amplitude-modulated RFEM|Generation of amplitude-modulated electromagnetic fields: the device consists of a battery-driven radiofrequency (RF) electromagnetic field generator connected to a 1.5 meter long 50 Ohm coaxial cable, to the other end of which a spoon-shaped mouthpiece made of steel is connected with the inner conductor. The RF source of the device corresponds to a high-level amplitude-modulated class C amplifier operating at 27.12 MHz. The modulation frequency can be varied between 0.01 Hz and 150 kHz with a modulation depth of 85 ± 5%. The RF output is adjusted to 100 mW into a 50 Ohm load using a sinusoidal modulated test signal, which results in an emitting power identical to that of the device used in the treatment of insomnia (Pasche et al 1996, 19:327-336).
16278137|NCT00805324|Drug|Desloratadine|desloratadine syrup; 5.0 mL once daily for 28 days
16278138|NCT00805311|Procedure|Carotid Endarterectomy|CEA involves a neck incision and physical removal of the plaque from the inside of the artery
16278139|NCT00805311|Drug|atorvastatin, aspirin, losartan, amlodipine|aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
16278140|NCT00805298|Drug|methylprednisolone|32 mg before surgery, 16 mg twice daily the day after surgery
16278141|NCT00805298|Drug|placebo|two tablets before surgery, one tablet twice daily on the day after surgery
16278142|NCT00805298|Drug|xyloplyin adrenalin|lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
16278143|NCT00805298|Drug|marcain adrenalin|bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
16278144|NCT00805285|Drug|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg PO (oral) daily and hydrocortisone 100 mL PR (enema) for an 8-week period. The doses of each drug to be used in the pilot study are standard doses used in clinical practice. After 8-weeks, the budesonide will be tapered in the following manner: 1) budesonide 6 mg PO daily and hydrocortisone 100 ml PR every other day (EOD) for 3 weeks then 2) budesonide 3 mg PO daily and hydrocortisone 100 ml PR 2 x per week for 3 weeks then 3) discontinue budesonide.
16278145|NCT00805272|Other|QTF-TB Gold and T-SPOT TB|evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
16278146|NCT00805259|Behavioral|Financial incentives|Financial incentives based on use of software designed to promote cognitive function
16278147|NCT00805233|Drug|combination ranibizumab + bromfenac|ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months. Plus one drop of bromfenac in the study eye twice per day, each day, for 12 months.
16278148|NCT00805233|Drug|ranibizumab injection alone|ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months
16278149|NCT00805220|Other|Nordic Walking|Walking training with and without poles will be twice a week. The sessions last 20 minutes each and consist of walking, stretching and mobility exercises. This will last 8 weeks in a total of 16 sessions. A therapist will closely monitor your exercises and modify them according to your needs and comfort
16278151|NCT00805207|Drug|testosterone|Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.
16278152|NCT00805207|Drug|glucocorticoid|Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.
16278153|NCT00805207|Device|continuous positive airway pressure|Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention.
16278154|NCT00805207|Drug|Estrogen|Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.
16278155|NCT00805207|Other|Control|No treatment with studies performed 31 to 72 days apart
16278156|NCT00805194|Drug|placebo plus docetaxel|placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
16278157|NCT00805194|Drug|BIBF 1120 plus docetaxel|BIBF 1120 2 times daily along with standard therapy of docetaxel
16278158|NCT00805155|Drug|Mometasone Furoate 0.1% Topical Lotion-Reference Product|Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
16278159|NCT00805155|Drug|Mometasone Furoate 0.1% Topical Lotion-Test product 1|Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
16278160|NCT00805155|Drug|Mometasone Furoate 0.1% Topical Lotion-Test Product 2|Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
16278161|NCT00805142|Drug|Tapentadol PR|Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.
16278162|NCT00805129|Drug|Everolimus|Everolimus (RAD001) is a novel oral derivative of rapamycin. Everolimus will be administered orally as a once-daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take Everolimus in the morning, at the same time each day. Everolimus should be taken by the patient in a fasting state or with no more than a light fat-free meal.
16278163|NCT00805116|Dietary Supplement|Whale blubber oil|15 ml/day for 4 months, divided on dosage morning and evening, orally.
16278164|NCT00805116|Dietary Supplement|Cod liver oil|15 ml/day for 4 months, divided on dosage morning and evening, taken orally
16278165|NCT00805103|Radiation|Hypofractionated stereotactic radiotherapy|Patients will be initially administered 8 Gy RT (level). The dose at each level will be increase by 2 Gy up to level 4. If ≥ 2 of the patients in a dose cohort encounter a DLT, then that dose level will be declared the maximum administered dose. An additional 3 patients will then be entered at the previous dose level and provided no more than one patient experiences a DLT, that level will be declared the maximum tolerated dose (MTD). Up to 6 more patients can be treated at the given dose level while awaiting the results of 6 months of follow-up.
16278166|NCT00805090|Drug|Sporanox|200 mg
16278167|NCT00805090|Drug|Diclofenac Sodium|37.5 mg
16278168|NCT00805077|Procedure|mechanical ventilation|mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
16278169|NCT00805077|Other|tidal volume|tidal volume of 10 ml/kg of ideal body weight without PEEP
16278170|NCT00805064|Drug|triamcinolone and bevacizumab|
16278171|NCT00805038|Behavioral|Transplant navigator|Navigator will provide help to patients in completing specific steps in transplant process.
16278172|NCT00805038|Behavioral|Usual care|Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.
16278173|NCT00805025|Drug|AZLI|75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator
16278174|NCT00805012|Drug|docetaxel+CDDP|docetaxel+CDDP
16278175|NCT00805012|Drug|docetaxel+S-1|docetaxel+S-1
16278176|NCT00804999|Drug|Clear Care|neutralized Clear Care
16278177|NCT00804999|Drug|ReNu|overnight soak in solution
16278178|NCT00804999|Drug|OPTI-FREE|overnight soak in solution
16278179|NCT00804986|Drug|LY2428757|Once weekly for 12 weeks as a subcutaneous injection.
16278180|NCT00804986|Drug|Placebo|1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.
16278181|NCT00804973|Drug|LY2590443|200 milligrams (mg) as four 50-mg capsules, oral, once
16278182|NCT00804973|Drug|Placebo injection|saline solution, injection, once
16278183|NCT00804973|Drug|Sumatriptan|6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once
16278184|NCT00804973|Drug|Placebo capsule|4 capsules, once
16278185|NCT00804960|Drug|Letrozole|1) Letrozole 5 mg starting on cycle day 2, which will be continued until the day of trigger. Recombinant FSH at doses 100-225 units, as determined by BMI, AFC, age, and ovarian reserve markers will be added on cycle day 4. The dose will be adjusted based on the response. An antagonist will be administered once the lead follicle reaches 14-mm in diameter or when estradiol level reaches 250 pg/mL. Oocyte maturation will be triggered by 20 iu of leuprolide acetate.
16278186|NCT00804960|Drug|Std IVF Protocol|2) Long protocol with luteal phase GnRHa suppression with gonadotropin dose at 200-450 IU. Oocyte maturation will be triggered by 250 micg of ovidrel.
16278187|NCT00804947|Drug|Intravenous busulfan and melphalan|BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.
16278188|NCT00804934|Drug|Lucentis|0.5mg Lucentis every four months
16278189|NCT00804921|Drug|bevacizumab|
16278190|NCT00804921|Procedure|anterior chamber paracentesis|
16278191|NCT00804921|Drug|acetazolamide|
16278192|NCT00804921|Drug|brimonidine|
16278193|NCT00804908|Drug|temozolomide|temozolomide capsule administered orally once daily for 5 days every 28 days
16278194|NCT00804908|Drug|ABT-888|ABT-888 capsule administered orally twice daily for 7 days every 28 days
16278195|NCT00804908|Other|Placebo|Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days
16278450|NCT00803062|Other|Questionnaire Administration|Ancillary studies
16278197|NCT00804895|Drug|PROAMP, subcutaneous serum physiological saline|Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.
16278198|NCT00804895|Drug|Verapamil|standard prophylactic treatment
16278199|NCT00804869|Device|PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)|PalmScan biometric measurements
16278200|NCT00804869|Device|Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).|A-mode biometric measurements group
16278201|NCT00804856|Drug|BI 6727 (d1 and 15)|BI 6727 (d1 and 15 - one hour iv.v)
16278202|NCT00804856|Drug|BI 6727 (d1 and 15)|BI 6727 (d1 and 15 - one hour iv.v)
16278203|NCT00804856|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c.
16278204|NCT00804856|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c.
16278205|NCT00804843|Drug|Atorvastatin/niacin extended-release|80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
16278206|NCT00804843|Drug|Atorvastatin|10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
16278207|NCT00804843|Drug|Simvastatin|(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
16278208|NCT00804843|Drug|Simvastatin|(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
16278209|NCT00804830|Drug|Bevacizumab|Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
16278210|NCT00804817|Behavioral|Control Group|Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
16278211|NCT00804817|Behavioral|SCION-HSCT program|"Intervention: Patients receive SCION-HSCT program a multi-modular somatic-psycho-social care intervention. consisting of 3 modules: Activity Enhancement, Oral Mucositis Prevention and Mal-Nutrition Avoidance.
~The intervention will be conducted by specially trained oncology nurses and will include components of knowledge, skills training, and coaching to improve self management. The intervention starts at admission followed by booster sessions during the period of hospitalization. Patients will be scheduled to an individualized physical activity program incl. endurance training on light level 60-80% of max heart rate. Additionally the patient will be counselled to follow a mouth care protocol based on self assessment of the mouth to prevent oral mucositis. Both interventions are accompanied by a systematic screening of the nutritional situation. All three interventions are aimed to improve patients' adherence to self management strategies of side effects."
16278212|NCT00804804|Other|Sleep deprivation and multiple rest|To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
16278213|NCT00804804|Other|Sleep deprivation and multiple rest|To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
16278214|NCT00804804|Other|Sleep deprivation and multiple rest|To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
16278215|NCT00804804|Other|Sleep deprivation and multiple rest|To determine the evolution of the executive functions during a 40-hour extended wakefulness period or during a 40-hour multiple nap protocol in constant experimental conditions of confinement
16278216|NCT00804791|Other|Systane Ultra Lubricant Eye Drops|artificial tears solution for lubricating the cornea
16278217|NCT00804791|Other|Unisol 4 Saline Solution|saline solution for irrigating the cornea
16278218|NCT00804765|Other|Therapeutic education|Intensive training individual and collective teaching
16278219|NCT00804765|Other|Follow-up|classical follow-up with two individual consultations
16278220|NCT00804752|Drug|Adding vitamin D|Adding 1000IU/Vitamin D daily
16278221|NCT00804752|Drug|Vitamin D|Addition of 1000IU/day Vitamin D
16278222|NCT00804739|Other|Mother-Infant Treatment Team|This is a treatment team approach that allows for outreach. The clinical team will be a nurse practitioner of psychiatry and a social worker. The nurse practitioner will provide either interpersonal psychotherapy, sertraline or both as indicated.
16278223|NCT00804726|Device|Akreos MI Five-O|Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation
16278224|NCT00804713|Drug|BST|0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
16278225|NCT00804713|Drug|TST|Administer TB Skin test (TST)
16278226|NCT00804713|Other|QFT|Perform QFT TB test
16278227|NCT00804713|Other|T-spot|Perform T-Spot TB test
16278228|NCT00804700|Behavioral|Active teaching in synchronous listening to music while exercising|Subjects will be instructed to exercise while listening to four audio tutorials that are stored on their MP-3 player. These tutorials guide the subject on how to synchronize his or her body movements to the beat of the music.
16278229|NCT00804687|Other|Placebo|Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
16278230|NCT00804687|Drug|JNJ-39220675|Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
16278231|NCT00804687|Drug|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
16278232|NCT00804674|Drug|bupivacain|
16278233|NCT00804674|Drug|placebo|
16278234|NCT00804661|Device|SENTEC device|Nocturnal recording SAO2 and PtcCO2 and wrist movements by means of actigraphy
16278235|NCT00804648|Drug|Timolol Maleate in Sorbate|0.5%
16278236|NCT00804648|Drug|Timolol hemihydrate|0.5%
16278237|NCT00804648|Drug|Timolol maleate gel forming solution|0.5%
16278238|NCT00804622|Drug|telbivudine|daily oral administration,600mg,over 12 weeks
16278239|NCT00804622|Drug|tenofovir disproxil fumarate|daily oral administration,300mg,over 12 weeks
16278240|NCT00804622|Drug|telbivudine plus tenofovir disproxil fumarate|daily oral administration of telbivudine 600 mg and tenofovir disproxil fumarate 300 mg in combination given over 12 weeks
16278241|NCT00804609|Drug|DepoDur following epidural lidocaine|"All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.
~Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
16278242|NCT00804609|Drug|DepoDur following spinal anesthetic|"Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.
~Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
16278243|NCT00804596|Device|Apollo Blood Glucose Monitoring System|Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.
16278244|NCT00804570|Drug|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
16278245|NCT00804570|Drug|placebo|once daily, orally, 16 weeks
16278246|NCT00804544|Device|SPECT/CT|SPECT/Low-Dose MultiSclice CT
16278247|NCT00804531|Drug|Visipaque - Hydrocortancyl|Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
16278248|NCT00804531|Drug|Placebo comparator|Visipaque - 320 mg I/ml - 1 ml in intra-discal route
16278249|NCT00804518|Other|Aerobic interval training|High intensity aerobic interval training consists of 10 minutes warm up at ~60% of maximal heart rate, 4x4 minutes intervals at 90-95 % of maximal heart rate corresponding to 85-90% of VO2max) walking/running uphill on a treadmill, with three minutes active pause between the exercise bouts at 60-70% maximal heart rate. The session is terminated with 3 minutes cool down. Total exercise time is 38 minutes.The training is supervised by an exercise physiologist and the subjects train 3 times per week for 12 weeks.
16278250|NCT00804505|Device|SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens|Comparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days.
16278251|NCT00804505|Device|SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens|Comparison to test lens: Daily use for minimum 8 hours up to 90 days.
16278252|NCT00804492|Behavioral|Multifaceted intervention|consulted, educated, referred or receive an exercise training for their fitness, strength and balance
16278253|NCT00804479|Other|No intervention.|
16278254|NCT00804466|Device|OncoE6|HPV oncoprotein assay
16278255|NCT00804466|Device|EVA System|low-cost colposcope
16278256|NCT00804453|Device|Cartridge blood set|Once a week
16278257|NCT00804453|Device|Standard blood line|Once a week
16278258|NCT00804440|Drug|Ibuprofen Tablets, 800 mg|
16278259|NCT00804427|Dietary Supplement|Fish oil (90% triglycerides)|
16278260|NCT00804427|Dietary Supplement|Fish oil (60% triglycerides)|
16278261|NCT00804427|Dietary Supplement|Fish oil (ethyl esters)|
16278262|NCT00804427|Dietary Supplement|Soy oil|
16278263|NCT00804414|Drug|SBG|Solution for topical use
16278264|NCT00804414|Drug|Placebo Comparator|Solutin for topical use
16278265|NCT00804401|Drug|Naproxen Tablets, 500 mg|
16278266|NCT00804388|Procedure|Total hip arthroplasty|32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
16278267|NCT00804375|Drug|2PX|cutaneous solution to be applied twice daily for 84 days
16278268|NCT00804375|Drug|Placebo|cutaneous solution to be applied twice daily for 84 days
16278269|NCT00804349|Device|Autotitrating Positive Airway Pressure|Patients will be treated with Autotitrating Positive Airway Pressure therapy
16278270|NCT00804336|Drug|SOM230|Given subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter
16278271|NCT00804336|Drug|RAD001|Given orally once a day
16278272|NCT00804323|Procedure|Patter Scan Laser System (OptiMedica, Santa Clara, CA, USA)|Pattern Scan Laser trabeculoplasty
16278273|NCT00804310|Drug|ixabepilone|This intravenous treatment will be performed on an outpatient basis. Ixabepilone (15 - 20mg/m2) will be given weekly for 3 weeks, then one week off, every 28 days (4 weeks). The study doctor will decide how long to keep the participant on this treatment based on how the participant is tolerating the drug and how it is affecting the tumor.
16278274|NCT00804310|Drug|lapatinib ditosylate|Lapatinib (1000-1500 mg) will be administered orally on a daily basis. The study doctor will decide how long to keep the participant on this treatment based on how the participant is tolerating the drug and how it is affecting the tumor.
16278275|NCT00804297|Drug|Octreotide (drug)|
16278276|NCT00804284|Biological|DTaP-IPV/Hib|0.5 mL, Intramuscular
16278277|NCT00804284|Biological|Other DTap Vaccines|0.5 mL, Intramuscular
16278278|NCT00804271|Drug|memantine|memantine tablets, OD, 12 weeks
16278279|NCT00804258|Drug|intraperitoneal chemotherapy|
16278280|NCT00804258|Other|educational intervention|
16278281|NCT00804258|Other|medical chart review|
16278282|NCT00804258|Other|questionnaire administration|
16278283|NCT00804258|Procedure|assessment of therapy complications|
16278284|NCT00804258|Procedure|end-of-life treatment/management|
16278285|NCT00804258|Procedure|psychosocial assessment and care|
16278286|NCT00804258|Procedure|quality-of-life assessment|
16278287|NCT00804245|Procedure|needle biopsy|Biopsy of positive findings found on CT scan
16278288|NCT00804245|Drug|PET-CT scans supplemented with 11C-Choline tracer|Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer
16278289|NCT00804232|Behavioral|childhood diabetes|the intervention compares three different regimes for children newly diagnosed with type 1 diabetes: (1) traditional hospital based care, (2) intensive psychological support to the family, and (3) home based family psychosocial support. A further aim is to identify families were the child runs the risk of decreased metabolic control and to give those families increased support.
16278290|NCT00804219|Biological|TBE vaccination and influenza vaccination|FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
16278291|NCT00804206|Drug|bevacizumab|Intravitreal bevacizumab before panretinal photocoagulation
16278292|NCT00804206|Drug|bevacizumab|Intravitreal Bevacizumab after panretinal photocoagulation
16278296|NCT00804180|Behavioral|Self-Injection Anxiety Counseling|This 5-session group intervention involves: psychoeducation; physiological treatment of anxiety though the instruction and practice of relaxation techniques; cognitive restructuring for anxiety-reduction; practice physiological and cognitive treatments through in vivo injection procedures; and problem solving strategies to generalize treatment gains.
16278297|NCT00804154|Drug|Intrathecal Resiniferatoxin|phase I, single-site, non-randomized, open-label, dose- escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy
16278298|NCT00804141|Drug|N-methylnaltrexone bromide (MOA-728)|MOA-728 will be administered as per the dose and schedule specified in the arm.
16278299|NCT00804128|Procedure|contrast-enhanced magnetic resonance imaging|
16278300|NCT00804128|Drug|Gadavist|Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging
16278301|NCT00804115|Drug|Latanoprost with Pilocarpine vs Timolol or Cosopt|Timolol 0.5% bid or Cosopt bid Latanoprost 0.005% qhs Pilocarpine 2%
16278302|NCT00804102|Device|Transcorneal Electrical Stimulation|Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
16278303|NCT00804102|Device|DTL-electrode attached without energy|DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.
16278304|NCT00804089|Procedure|Traditional needle acupuncture|Traditional needle acupuncture using traditional meridian acupoints and Ashi (tender) points
16278305|NCT00804089|Procedure|Myofascial trigger point dry needling|Superficial dry needling of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching
16278306|NCT00804089|Procedure|Myofascial trigger point acupressure|Blunt needle acupressure of myofascial trigger points found in the muscles related to low back pain, followed by their postisometric stretching
16278307|NCT00804076|Biological|NP2|Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.
16278308|NCT00804063|Procedure|drawing blood sample|fasting blood sample
16278309|NCT00804050|Drug|infusion A: rEPO|rEPO 40.000 unit/week for 4 mounths, then patients who have obtained an erythroid response, will continue for another 4 months with therapy rEPO. Patients who have not obtained an erythroid response, will increase the dose rEPO to 80,000 units per week for an additional 4 months.
16278310|NCT00804050|Drug|B Infusion rEPO combined with vitamins pills|rEPO 40.000 unit/week plus acid 13 cis-retinoic (20 mg/die) plus Dihydroxyvitamin D3 (1 μg os/die), for 4 mounths. Patients who have obtained an erythroid response will continue for another 4 months with the same therapy. Patients who have not obtained an erythroid will increase the dose of rEPO to 80,000 units per week for additional 4 months.Patients also will continue with the same doses of acid 13-cis-retinoic acid and Dihydroxyvitamin D3
16278311|NCT00804037|Procedure|Injection Snoreplasty|Injection of 0,5 ml of the sclerosing agent into the soft palate (3 points)
16278312|NCT00804024|Device|ClearWay™ RX Local Therapeutic Infusion Catheter|The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.
16278313|NCT00804011|Other|ATC|Automatic tube compensation
16278314|NCT00804011|Other|PSV|Pressure support ventilation
16278315|NCT00803985|Procedure|Total Extraperitoneal repair (TEP)|Operation for primary inguinal hernias i men
16278316|NCT00803985|Procedure|Lichtenstein|Operation for primary inguinal hernias i men
16278317|NCT00803972|Drug|rHuPH20|recombinant human hyaluronidase PH20
16278318|NCT00803972|Drug|Insulin Human Injection|injection
16278319|NCT00803972|Drug|Insulin Lispro Injection|injection
16278320|NCT00803959|Other|Office evaluation|Office evaluation
16278321|NCT00803959|Other|UDS|Urodynamics
16278322|NCT00803946|Drug|Ibuprofen Tablets, 800 mg|
16278323|NCT00803933|Drug|DB289|Pafuramidine maleate (DB289), 100 mg BID orally
16278324|NCT00803933|Drug|Pentamidine|Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
16278325|NCT00803907|Drug|Imiquimod 5% cream|Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
16278326|NCT00803894|Drug|MK0752|Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.
16278327|NCT00803894|Drug|Comparator: MK0752.|Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.
16278328|NCT00803894|Drug|Comparator: Placebo|Single dose placebo capsules: there will be a 7-day washout period between treatments.
16278329|NCT00803881|Other|nasal lavage and sputum collection|non-invasive longitudinal assessment of pathogen colonization in both airway levels
16278330|NCT00803868|Drug|varenicline|up to 1mg po bid for 9 weeks
16278331|NCT00803868|Drug|placebo|placebo matching study drug up to 1mg po bid
16278332|NCT00803855|Drug|AZD1446|oral, single dose
16278371|NCT00803595|Drug|CS-8958|CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
16278372|NCT00803595|Drug|oseltamivir phosphate|CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.
16278405|NCT00803374|Drug|AntiCD137|Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
16278333|NCT00803842|Drug|doxycycline|Doxycycline (the study drug) will be provided to all subjects as 100 mg tablets. They will be allocated enough doxycycline to last them until their next scheduled visit. The doxycycline tablets should be taken orally (only) at a dosage of 100 mg every 12 hours. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. The doxycycline tablets should not be taken with foods that contain calcium. The absorption of doxycycline is reduced when taking bismuth subsalicylate. Duration of study period if 14 days
16278334|NCT00803829|Other|Synbiotic (Synergy1/B. longum)|Probiotic Bifidobacterium longum Prebiotic Synergy 1
16278335|NCT00803816|Drug|everolimus|everolimus 1.0 - 2.5mg oral daily dosage
16278336|NCT00803803|Drug|Pilocarpine Concentration|Varying concentration 0.5 to 8%
16278337|NCT00803803|Drug|Pilocarpine Frequency|1 to 4 times daily
16278338|NCT00803790|Drug|alendronate sodium+vitamin D combination|A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
16278339|NCT00803790|Drug|Comparator: alendronate|A single dose tablet of 70mg alendronate in one treatment period of each sequence.
16278340|NCT00803790|Dietary Supplement|Comparator: Vitamin D|Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.
16278341|NCT00803777|Device|Investigational Blood Glucose Monitoring System|Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.
16278342|NCT00803764|Drug|Naproxen Tablets, 500 mg|
16278343|NCT00803751|Device|Truview EVO2 laryngoscope|will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
16278344|NCT00803751|Device|Macintosh laryngoscope|Intubation using the traditional Macintosh laryngoscope
16278345|NCT00803738|Drug|Terconazole Vaginal Suppository|Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
16278346|NCT00803738|Drug|Terazol Vaginal Suppository|Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
16278347|NCT00803725|Drug|Mepivacaine without fentanyl|45 mg 1.5% mepivacaine injection for spinal anesthesia
16278348|NCT00803725|Drug|Mepivacaine with Fentanyl|10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia
16278349|NCT00803712|Drug|Cinacalcet|Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
16278350|NCT00803712|Drug|Vitamin D|Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
16278351|NCT00803699|Dietary Supplement|placebo|daily placebo capsules for 12 months
16278352|NCT00803699|Dietary Supplement|selenium as L-selenomethionine|daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months
16278353|NCT00803686|Drug|Oral rsCT tablet|On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.
16278354|NCT00803686|Drug|Oral Placebo Tablet|Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
16278355|NCT00803686|Drug|Oral rsCT tablet|Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
16278356|NCT00803686|Drug|Fortical (rsCT) nasal spray|Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
16278357|NCT00803673|Drug|100mcg|100mcg '719
16278358|NCT00803673|Drug|500mcg|500mcg '719
16278359|NCT00803673|Drug|1000mcg|1000mcg '719
16278360|NCT00803673|Drug|Placebo|Placebo '719
16278361|NCT00803647|Biological|cetuximab|500 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles. Cetuximab dose will be escalated by 100 mg/m2 every 2 weeks to a maximum dose of 800 mg/m2 if, at the time of retreatment, skin rash is less than or equal to grade 1, diarrhea is grade 0 (defined as less than or equal to 3 stools per day over baseline), and the patient is not experiencing any other greater than or equal to grade 2 toxicity attributed to cetuximab.
16278362|NCT00803647|Drug|5-FU|3000 mg/m2 IV continuous infusion over 46 hours every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
16278363|NCT00803647|Drug|oxaliplatin|85 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
16278364|NCT00803647|Drug|leucovorin|400 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
16278365|NCT00803634|Drug|Clevidipine|Clevidipine was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative IV antihypertensive agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Patients who received an alternative antihypertensive agent along with the study drug were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered approximately 1 hour prior to the termination of clevidipine with study drug down-titrated or terminated in order to maintain the desired blood pressure level.
16278366|NCT00803634|Drug|Standard of Care IV antihypertensive|SOC IV antihypertensive agent will be administered for a minimum of 30 min and, if medically warranted, may continue beyond 96 hours at the investigator's discretion. As with clevidipine, the SOC agent was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Higher dose titration rates were required to be attempted prior to making the decision to switch to or add on an alternative antihypertensive agent(s). Patients who received an alternative antihypertensive agent with SOC were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered per institutional practice.
16278367|NCT00803621|Other|Toxoplasma PCR assay|Toxoplasma PCR assay
16278368|NCT00803608|Device|TrueContour® Insole|Novel designed insole
16278369|NCT00803608|Device|Current standard of care insole|Current Medicare approved A5513 insole
16278370|NCT00803595|Drug|CS-8958|CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
16278373|NCT00803582|Procedure|Traditional Chinese acupuncture|Acupuncture at two Hegu (LI4) and two Lieque (Lu7) points on the wrist, one Lianquan (CV23) and two Renying (St9) points on the neck and two Zhaohai (Ki6) for 12 30-minute sessions
16278374|NCT00803582|Procedure|Placebo acupuncture|Placebo acupuncture at two Hegu (LI4) and two Lieque (Lu7) points on the wrist, one Lianquan (CV23) and two Renying (St9) points on the neck and two Zhaohai (Ki6) for 12 30-minute sessions.
16278375|NCT00803569|Biological|ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine|The vaccine comprises the modified canary pox vector, ALVAC(2), inserted with the following genes: NYESO-1(M), TRICOM (LFA-3, ICAM-1, B7.1), vvE3L, vvK3L. The vaccine is administered at a dose of 0.5 mL SC.
16278376|NCT00803569|Biological|Sargramostim|The GM-CSF sargramostim is administered at a dose of 100 μg SC.
16278377|NCT00803556|Drug|Alvespimycin|Solution, IV, 60-100 mg/m2, weekly until disease progression or DLT
16278378|NCT00803556|Drug|Trastuzumab|Solution, IV, 2-4 mg/kg, weekly until disease progression or DLT
16278379|NCT00803556|Drug|Paclitaxel|Solution, IV, 60-90 mg/m2, weekly until disease progression or DLT
16278380|NCT00803543|Drug|Valacyclovir|500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
16278381|NCT00803543|Drug|Placebo|Dosage: Two tablets once a day for 24 weeks
16278382|NCT00803530|Drug|ATO + Ascorbic acid|"ATO will be diluted in 250 ml of normal saline solution at a dosage of 0.3 mg/Kg during the first week of therapy and at a dosage of 0.25 mg/Kg during the subsequent weeks (week 2 to 16), and administered intravenously over a 1-2 hour period.
~The dose of ascorbic acid will be 1000 mg in 100 cc D5W or normal saline solution (NaCl 0.9 %) (protected from light and air) administered as an IV infusion over 15 to 30 minutes. The dosing solution is not to be mixed with any alkaline solution."
16278383|NCT00803504|Procedure|ocular blood flow measurement|
16278384|NCT00803491|Other|Problem based learning|Group sessions under supervision from a nurse. Each group including 8 subjects. 10 occasions during a period of one year.
16278385|NCT00803491|Other|Traditional rheumatology care.|Individually base.
16278386|NCT00803478|Procedure|LASIK|
16278389|NCT00803452|Drug|doxycycline|Oral doxycycline 100mg bid
16278390|NCT00803452|Drug|azithromycin|topical 1% azithromycin daily to eye
16278391|NCT00803439|Drug|Clobetasol Propionate 0.05% Foam-Reference Product|Small amount applied and evaluated over the course of two days
16278392|NCT00803439|Drug|Clobetasol Propionate 0.05% Foam-Test product|Small amount applied and evaluated over the course of two days
16278393|NCT00803426|Procedure|Sciatic nerve blockade for ankle/foot surgery|Injection of local anesthetic near the nerve to achieve anesthesia.
16278394|NCT00803413|Behavioral|Back School Intervention|Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, and spine preventive care; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening)
16278395|NCT00803413|Behavioral|Supervised Walking Intervention|Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised walking in group.
16278396|NCT00803413|Behavioral|Back School and Walking|Weekly sessions of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities
16278397|NCT00803413|Behavioral|Control Group|Weekly sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention.; beside the 2-page folder content this group received no other information about LBP, BS or walking all along the follow-up.
16278398|NCT00803400|Drug|Alprazolam|"The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.
~Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12."
16278399|NCT00803400|Drug|Alprazolam + Aerobic exercise|"The patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for future exercise indication.
~Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.
~Then they follow a protocolized aerobic exercise plan for this study during 12 weeks.
~The type of selected exercise consists of a rapid walk for 30 minutes divided in stages.
~After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association)."
16278400|NCT00803387|Drug|Travaprost without BAC (Travatan Z)|A double blind comparison was used to assess whether Xalatan or TrvatanZ affects the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results. One Drop from both bottles will be dispensed in the respective eye once a day.
16278401|NCT00803374|Drug|AntiCD137|Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
16278402|NCT00803374|Drug|AntiCD137|Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
16278403|NCT00803374|Drug|AntiCD137|Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
16278404|NCT00803374|Drug|AntiCD137|Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
16278406|NCT00803374|Drug|Ipilimumab|Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
16278407|NCT00803361|Drug|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
16278408|NCT00803361|Drug|Placebo|placebo capsules, oral, once a day for 15 weeks
16278409|NCT00803348|Drug|Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2|Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2
16278410|NCT00803348|Drug|Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2|Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2
16278411|NCT00803348|Drug|Saline control|Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2
16278412|NCT00803335|Drug|Vaginal conjugated estrogen cream 0.5gm|Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
16278413|NCT00803335|Drug|Vaginal conjugated estrogen cream 1.0gm|Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
16278414|NCT00803309|Drug|pegylated interferon alpha-2b|1.5 µg/kg once weekly, syringe, 24 weeks
16278415|NCT00803309|Drug|Ribavirin|800-1400 mg per os, daily, tablets, 24 weeks
16278416|NCT00803309|Drug|pegylated Interferon alpha-2b|1.5 µg/kg once weekly, syringe, 12 weeks
16278417|NCT00803309|Drug|Ribavirin|800-1400 mg per os, daily, tablets, 12 weeks
16278418|NCT00803296|Other|Oral glucose tolerance test (OGTT)|
16278419|NCT00803296|Other|Isoglycemic intravenous glucose infusion|
16278420|NCT00803283|Drug|Hydromprphone Hydrochloride (HCl) OROS|Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.
16278421|NCT00803283|Drug|Morphine Sustain Release (SR)|Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.
16278422|NCT00803270|Drug|Non-Surgical Intervention|Both oral urge incontinence medication and behavioral treatment
16278423|NCT00803270|Procedure|Surgical|Initial surgical (stress incontinence surgery) treatment approach.
16278424|NCT00803257|Other|Lumbrical splint and Lumbrical exercises|Subjects receive one of four possible interventions - Dose and Frequency are the same for each
16278425|NCT00803244|Drug|300 IR|300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season
16278426|NCT00803244|Drug|Placebo|Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season
16278427|NCT00803218|Drug|Fluticasone Propionate 0.005% Ointment-Reference Product|Small amount applied and evaluated over the course of one day
16278428|NCT00803218|Drug|Fluticasone Propionate 0.005% Ointment-Test product|Small amount applied and evaluated over the course of one day
16278429|NCT00803205|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water.
16278430|NCT00803205|Drug|Placebo|Placebo matching to ataluren will be provided.
16278431|NCT00803192|Drug|Famotidine Tablets, 40 mg|
16278432|NCT00803179|Drug|Nutropin AQ|Based on recommendations from the 2007 GH Deficiency Consensus Workshop on adult GH deficiency, the recommended initiation of treatment for adult males is 0.2mg/d and for women 0.4mg/d, with a titration upwards based on insulin-like growth factor (IGF-1) (product of GH stimulation at target tissues) levels and patient response. IGF-1 will be monitored at the 3,4,5 and 11 month intervals. For subjects under the age of 25 with an open epiphysis of the hand and/or wrist we will treat with the dose of 0.3mg/kg/week. Subjects will be on growth hormone for 8 months with a baseline visit prior to initiation of therapy and a 3 month follow-up visit after stopping therapy.
16278436|NCT00803153|Procedure|Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]|
16278437|NCT00803140|Procedure|Cautery vs Active Control Arm (Scalpel)|"Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a cut setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used.
~A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible.
~The closure will be standardized."
16278438|NCT00803127|Device|vs-sense|detection swab
16278439|NCT00803114|Drug|Preservative-free epidural morphine|One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery
16278440|NCT00803114|Drug|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
16278441|NCT00803101|Biological|Beriplex® P/N (Kcentra)|Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
16278442|NCT00803101|Biological|Fresh frozen plasma|Intravenous infusion, dosage depending on baseline INR and body weight
16278443|NCT00803088|Device|The Alair System|Treatment of airways with the Alair System
16278444|NCT00803075|Device|Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System|
16278445|NCT00803062|Biological|Bevacizumab|Given IV
16278446|NCT00803062|Drug|Cisplatin|Given IV
16278447|NCT00803062|Other|Laboratory Biomarker Analysis|Correlative studies
16278448|NCT00803062|Drug|Paclitaxel|Given IV
16278449|NCT00803062|Other|Quality-of-Life Assessment|Ancillary studies
16278451|NCT00803062|Drug|Topotecan Hydrochloride|Given IV
16278452|NCT00803049|Drug|Teriflunomide (HMR1726)|Tablet, oral administration QD.
16278453|NCT00803023|Drug|Sodium Oxybate|4.5 grams per night taken in two equally divided doses
16278454|NCT00803023|Drug|Sodium Oxybate & 6 Tablets|4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
16278455|NCT00803023|Drug|Sodium Oxybate & 8 Tablets|6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
16278456|NCT00803023|Drug|Sodium Oxybate Oral Solution (6 grams)|6 grams per night taken in two equally divided doses
16278457|NCT00803010|Drug|Tacrolimus (TAC)|Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
16278458|NCT00803010|Drug|Methotrexate (MTX)|Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.
16278459|NCT00803010|Drug|Rapamycin (RAPA)|Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.
16278460|NCT00802997|Device|Sinergy|radiofrequency denervation
16278461|NCT00802997|Device|Placebo sham|sham procedure
16278462|NCT00802984|Device|Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System|
16278463|NCT00802971|Dietary Supplement|FOS|Oligofructose (FOS, BioCare Ltd, Birmingham, England) powder will be distributed in sachets of 10 g. Two sachets are to be included in daily nutrition, preferentially 10 g diluted in water at breakfast and before supper.
16278464|NCT00802958|Drug|Halobetasol Propionate 0.05% Ointment-Reference Product|Small amount applied and evaluated over the course of a day
16278465|NCT00802958|Drug|Halobetasol Propionate 0.05% Ointment-Test Product|Small amount applied and evaluated over the course of a day
16278466|NCT00802945|Drug|NKTR-102|NKTR-102 given on a q14 day schedule
16278467|NCT00802945|Drug|NKTR-102|NKTR-102 given on a q21 day schedule
16278468|NCT00802932|Device|Non-contrast Computed Tomography (CT) Scans (Metallic Markers)|Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6.
16278469|NCT00802932|Device|Non-contrast CT Scans (Metallic Markers)|Non-contrast CT Scans prior to start of radiation therapy and on Day 5.
16278470|NCT00802919|Drug|Varenicline|Varenicline 1-2 mg/day
16278471|NCT00802919|Drug|Placebo for varenicline|Placebo
16278472|NCT00802906|Device|subthreshold micropulselaser|on demand if leakage is persistent or recurs after initial treatment
16278473|NCT00802906|Drug|bevacizumab|1.5 mg initial intravitreal injection
16278474|NCT00802893|Drug|6R-BH4|6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
16278475|NCT00802893|Other|Placebo|placebo given BID for entire length of study
16278476|NCT00802880|Drug|Dacarbazine|
16278477|NCT00802867|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)|0.5 mL, Intramuscular
16278478|NCT00802841|Drug|nilotinib|Supplied as 200 mg tablets
16278479|NCT00802841|Drug|imatinib|Supplied as 100 mg and 400 mg tablets
16278480|NCT00802828|Drug|Famotidine Tablets, 40 mg|
16278481|NCT00802815|Drug|Etanercept|50 milligrams subcutaneously every week
16278482|NCT00802802|Drug|Efavirenz (EFV)|Participants will be administered oral EFV at a dose ranging from 50 mg to 800 mg once daily, based on weight and CYP 2B6 genotype. EFV capsules will be opened into a small amount of a compatible food or liquid vehicle; the smallest amount of food or liquid that will enable the child to swallow the capsule contents should be used (i.e., EFV should not be taken with a meal).
16278483|NCT00802802|Drug|Rifampin-containing anti-TB therapy|Treatment with rifampin-containing anti-TB treatment regimen. Treatment will last at least 24 weeks and up to 36 weeks.
16278484|NCT00802776|Procedure|Femtosecond laser assisted keratoplasty|
16278485|NCT00802776|Procedure|PKP|
16278486|NCT00802763|Device|NORMA-SENSE|Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.
16278487|NCT00802750|Device|LoFric POBE|"LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter LoFric POBE, Nelaton 40 cm, CH 12 with current solvent before being catheterized with the test catheters."
16278488|NCT00802750|Device|LoFric POBE|"Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter LoFric POBE, Nelaton 40 cm, CH 12 with current solvent before being catheterized with the test catheters."
16278489|NCT00802737|Drug|Ofatumumab|Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years
16278490|NCT00802724|Behavioral|Classification-directed treatment|People in the Classification-directed treatment will be treated based on their direction-specific LBP classification. Treatment will consist of 3 primary components. The first component of treatment will be analysis and instruction in modification of the person's direction-specific alignment and movement strategies during symptomatic functional activities and activities in which the person uses similar strategies to those displayed with symptomatic functional activities. The second component is education about the principles of tissue injury and healing and the need to keep active. The third component is exercise prescription that consists of practice in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can be modified to eliminate symptoms.
16278491|NCT00802724|Behavioral|Non-specific treatment|People in the Non-specific treatment will be provided treatment that incorporates treatment commonly cited in the literature for people with chronic LBP. The first component of treatment will consist of training in functional activities based on biomechanical principles. The second component will include general education about low back pain. The third component is exercise prescription that is directed at improving the strength and flexibility of the trunk and limbs.
16278492|NCT00802711|Radiation|3-dimensional conformal radiation therapy|Given twice a day for 10 fractions
16278493|NCT00802711|Radiation|brachytherapy|Given twice a day for 10 fractions
16278494|NCT00802698|Device|Transcorneal electric stimulation|central artery occlusion
16278495|NCT00802698|Device|Transcorneal stimulation|new waveform
16278496|NCT00802698|Device|transcorneal electric stimulation|Novel waveform central artery occlusion
16278583|NCT00802074|Drug|Ritonavir|100 mg BID or QD
16278497|NCT00802685|Drug|Early ibuprofen|"IBUPROFEN SCHEDULE: initial dose 10 mg/kg, then 2 doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy is blinded. At PDA diagnosis, infants randomized to early treatment receive blinded ibuprofen. Infants randomized to late treatment receive blinded placebo. Hemodynamically significant PDA criteria: SIGNS OF PDA + pulmonary hemorrhage OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (due to PDA) defined as at least two of the following: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Once hemodynamically significant PDA criteria met, if echo is positive, infants from both groups can receive open label ibuprofen."
16278498|NCT00802685|Other|Late ibuprofen expectant group (placebo)|"Drug: Late ibuprofen expectant group (placebo): DOSING SCHEDULE: At PDA diagnosis infants randomized to late ibuprofen expectant group will receive blinded placebo. If hemodynamically significant PDA develops, infants now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (due PDA) defined as at least 2 of the following settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV."
16278499|NCT00802672|Drug|Ciclopirox Olamine Cream|topical cream
16278500|NCT00802672|Drug|Loprox Cream 0.77%|topical cream
16278501|NCT00802672|Drug|Placebo|topical cream
16278502|NCT00802659|Radiation|Stereotactic radiotherapy|This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
16278503|NCT00802646|Drug|saline|intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested
16278504|NCT00802646|Drug|fentanyl/bupivacaine/epinephrine|intrathecal 0.125% fentanyl/bupivacaine/epinephrine, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested The mother will then receive a new bag of fentanyl/bupivacaine/epinephrine.
16278505|NCT00802633|Device|Stapling device during radical cystectomy|Hemostasis
16278506|NCT00802633|Device|Ligasure tissue sealing device|Efficacy of tissue sealing device during hemostasis
16278507|NCT00802620|Procedure|Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia|Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia
16278508|NCT00802594|Drug|DB289|A single 100 mg DB289 capsule will be taken by mouth twice a day, morning and evening. Drug is to be taken with a glass of water within 15 minutes of the completion of meal.
16278509|NCT00802581|Procedure|Circumferential spread of local anesthetic|The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.
16278510|NCT00802581|Procedure|Non-circumferential spread of local anesthetic|"The anesthetist will perform a single shot injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve."
16278511|NCT00802568|Biological|anti-thymocyte globulin|
16278512|NCT00802568|Drug|busulfan|
16278513|NCT00802568|Drug|fludarabine phosphate|
16278514|NCT00802568|Procedure|allogeneic bone marrow transplantation|
16278515|NCT00802568|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16278516|NCT00802555|Drug|ARQ 197|360 mg administered twice daily until disease progression, unacceptable toxicity, or other discontinuation criterion is met
16278517|NCT00802529|Drug|Methylprednisolone|2 transtympanic injections at interval of two weeks.
16278518|NCT00802529|Drug|Gentamicin|2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
16278519|NCT00802516|Dietary Supplement|stanol ester|enriched margarine
16278520|NCT00802516|Dietary Supplement|sterol ester|enriched margarine
16278521|NCT00802516|Dietary Supplement|No intervention|placebo margarine
16278522|NCT00802503|Dietary Supplement|SPN|SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.
16278523|NCT00802490|Device|Brain-Computer Interface System|Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.
16278524|NCT00802490|Device|Brain-Computer Interface System|Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
16278525|NCT00802477|Procedure|Application of autologous blood products.|Autologous blood products (platelet rich and platelet poor plasma) produced by the PlasmaxTM Plus Plasma Concentration System will be applied to the surgical site.
16278526|NCT00802477|Procedure|Standard Modified Radical Mastectomy|Mastectomy per standard procedure without the application of autologous blood products.
16278527|NCT00802464|Biological|Herpes zoster vaccine GSK1437173A|2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
16278528|NCT00802464|Biological|Placebo|2 vaccinations at Months 0 and 2 with placebo
16278529|NCT00802451|Drug|Mesalamine|
16278530|NCT00802438|Biological|mepolizumab|up to three monthly doses of 750mg i.v. mepolizumab
16278531|NCT00802425|Drug|AM-111|single intratympanic injection
16278532|NCT00802425|Drug|placebo|single intratympanic injection
16278533|NCT00802412|Drug|Topiramate|Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).
16278534|NCT00802412|Drug|Placebo|Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
16278535|NCT00802399|Procedure|Partial Lacrimal Punctual Occlusion|Cauterization of the edge of all lacrimal punctum was carried out in all patients
16278536|NCT00802373|Drug|Solifenacin succinate|oral
16278537|NCT00802373|Drug|Tolterodine|Oral
16278538|NCT00802360|Drug|Menotropin|225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
16278539|NCT00802360|Drug|Progestrone vaginal insert|100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
16278540|NCT00802360|Drug|follitropin beta|225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
16278541|NCT00802360|Drug|Progesterone in oil|50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
16278542|NCT00802360|Drug|Ganirelix|Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
16278543|NCT00802347|Drug|I5NP|"Single IV injection of I5NP
~Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg
~Part B: 10.0 mg/kg"
16278544|NCT00802347|Drug|Saline|"Single IV injection of saline
~Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg
~Part B: 10.0 mg/kg"
16278545|NCT00802334|Drug|generic lopinavir/ritonavir|"Screening visit
~• Clinical and safety laboratory assessment. Viral load for patients on a PI-based regimen, if a VL results ≤ 3 months is not available
~Baseline visit
~• (Within 30 days after screening) Baseline clinical and laboratory assessment, patients who were on a Kaletra SGC formulation before baseline will undergo TDM. Start generic lopinavir/ritonavir tablets 200/50 in a 400/100mg bid dosage. Backbone will be chosen on the discretion of the study physician
~Week 4
~Steady state TDM lopinavir and ritonavir, at 10-12 hr after the last intake (Cmin)
~Clinical, safety and laboratory assessment
~Week 12: Clinical, safety and efficacy laboratory assessment Week 24: Clinical, safety and efficacy laboratory assessment Week 48: Clinical, safety and efficacy laboratory assessment"
16278546|NCT00802321|Drug|Dutasteride|Subjects will receive a single dose of 2, 3 or 4 mg of dutasteride based on random assignment.
16278547|NCT00802308|Drug|Morphine sulphate|Extended release tablet combined with alcohol or water
16278548|NCT00802295|Drug|Gonadotrophins|Administration of standard ovarian stimulation protocol
16278549|NCT00802295|Drug|Low dosis Gonadotrophin|
16278550|NCT00802282|Drug|psilocybin|dose manipulation as described in the protocol and to which volunteers are blinded
16278551|NCT00802282|Behavioral|Intensity of support for spiritual practice|Volunteers will be assigned to standard or high support, as described in the protocol
16278552|NCT00802282|Behavioral|Number of sessions|Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
16278553|NCT00802269|Procedure|Retinal laser photocoagulation|Retinal laser photocoagulation using a 532 nm laser
16278554|NCT00802256|Procedure|pulpotomy|removal of caries and cronal pulp tissue and then restoring of tooth
16278555|NCT00802243|Drug|leflunomide|
16278556|NCT00802230|Drug|Terbutaline Infusion|
16278557|NCT00802217|Drug|Civamide|5 mg liquid filled softgel capsules
16278558|NCT00802217|Drug|Civamide|5 mg x 2 liquid softgel capsules
16278559|NCT00802204|Radiation|PET scan|"Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride [18F] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet.
~Completed at baseline and post-VLCD"
16278560|NCT00802204|Procedure|Oral glucose tolerance test|Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD
16278561|NCT00802204|Procedure|MRI|An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese
16278562|NCT00802204|Behavioral|Psychological scales to assess attitudes and behaviors related to eating and quality of life|A series of short psychological scales will be administered during the study. Completed at baseline
16278563|NCT00802204|Other|Caloric Restriction|Obese participants only complete a short-term (~10days) very low calorie diet
16278564|NCT00802165|Device|Electroacupuncture|Group is given a total of four electroacupuncture treatments to evaluate it's anesthetic effectiveness
16278565|NCT00802165|Device|Sham electroacupuncture|Sham electroacupuncture treatment gives comparison to the experimental group
16278566|NCT00802152|Other|Home monitoring|The subject will take their blood pressure or glucose measurements 1-4 times per day, depending on patient condition. They will upload these measurements using the device to a secure website at least every other day. Data will be reviewed at least 2 times per week Monday through Friday by the clinic nursing staff. Data indicating problems, e.g., critical out of range values, will be communicated to the patient's primary care physician after review by the nurse. The physician will then determine what is needed for follow up action based on the patient's condition and data (e.g., telephone call to patient home, scheduling a clinic appointment, etc).
16278567|NCT00802139|Drug|venoferrum(iron sucrose)|administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.
16278568|NCT00802139|Drug|Bolgre (Iron acetyl-transferase)|Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks
16278569|NCT00802126|Drug|"Combination therapy IVB + rf-PDT"|low-fluence photodynamic therapy combined with intravitreal bevacizumab
16278570|NCT00802113|Drug|Fludarabine|Fludarabine 30 mg/m2 x 5 days
16278571|NCT00802113|Drug|Busulfan|Busulfan 3.2 mg/kg/day x 2 days
16278572|NCT00802113|Drug|Anti-Thymocyte Globulin|Anti-Thymocyte Globulin 2.0 mg/kg/day x 4 days
16278573|NCT00802100|Drug|Olanzapine|Daily tablets of 10 to 30 mg
16278574|NCT00802100|Drug|Perphenazine|Daily tablets of 8 to 24 mg
16278575|NCT00802100|Drug|Aripiprazole|Daily tablets of 10 to 30 mg
16278576|NCT00802100|Drug|Metformin|Daily tablets of 850 to 2550 mg
16278577|NCT00802100|Drug|Simvastatin|Daily tablets of 20 to 40 mg
16278578|NCT00802100|Drug|Benztropine|Daily tablets of 1 to 2 mg
16278579|NCT00802087|Drug|hydrocodone|Extended Release tablet
16278580|NCT00802087|Drug|hydrocodone & acetaminophen combination|Immediate Release tablet, hydrocodone and acetaminophen combination product
16278581|NCT00802074|Drug|Raltegravir|400mg BID
16278582|NCT00802074|Drug|Fosamprenavir|1400mg BID, 700 mg BID or 1400 mg QD
16278584|NCT00802061|Behavioral|Sleeping position in glaucoma patient|
16278585|NCT00802048|Drug|Local anesthetic (Ropivacaine)|Local anesthetic infusion
16278586|NCT00802048|Drug|Saline|Saline serum infusion
16278587|NCT00802035|Drug|Baclofen IR|30 mg; single dose
16278588|NCT00802035|Drug|Baclofen ER|30 mg; single dose
16278589|NCT00802022|Device|spinal cord stimulation|The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (50% of more pain reduction)a definite spinal cord system will be implanted.
16278590|NCT00802009|Drug|Dexamethasone|Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.
16278591|NCT00802009|Drug|Mepivicaine|Standard anesthetic solution administered during routine brachial plexus nerve blockade.
16278592|NCT00801983|Device|Alternative Keyboard|Subjects use either a typical or alternative keyboard
16278593|NCT00801970|Behavioral|Psychological Treatment|15 weekly therapy sessions.
16278594|NCT00801970|Behavioral|Group Therapy|3 months of weekly group therapy sessions.
16278595|NCT00801957|Drug|tacrolimus ointment 0.03%|topical application
16278596|NCT00801957|Drug|hydrocortisone acetate ointment 1%|topical application
16278597|NCT00801957|Drug|hydrocortisone butyrate ointment 0.1%|topical application
16278598|NCT00801957|Biological|Meningitec|im injection
16278599|NCT00801957|Biological|AC VAX|im injection
16278600|NCT00801944|Drug|Solifenacin succinate|oral
16278601|NCT00801944|Drug|Placebo|oral
16278602|NCT00801931|Drug|Alemtuzumab|Each dose of alemtuzumab is to be diluted in 5% dextrose in water (D5W) or normal saling (NS) (maximum concentration: 0.3 mg/mL) for intravenous (IV) infusion over two hours.
16278603|NCT00801931|Radiation|Total Body Irradiation|
16278604|NCT00801931|Drug|Melphalan|Melphalan 45mg/m2 (1.5 mg/kg IV for children <1 year of age or <10 kg) diluted in 0.9% NS to a concentration of 0.1- 0.45mg/ml, given IV over 30 minutes.
16278605|NCT00801931|Drug|Busulfan|(Busulfex) will be given IV in 0.9% sodium chloride or D5W to a final solution for infusion equal to 10 times the volume of diluent to Busulfex (to a concentration >0.5 mg/mL), through a central venous access device over 2 hours.
16278606|NCT00801931|Drug|Phenytoin|Fosphenytoin can be administered in D5W or 0.9% sodium chloride to a final concentration ranging from 1.5 to 25 mg PE/ml at a rate of 1-3 mg phenytoin sodium equivalents (PE)/kg/min up to 50-150 mg PE/minute.
16278607|NCT00801931|Drug|Fludarabine|Fludarabine will be given IV in 50-100 ml of D5W or 0.9% sodium chloride, over 30 minutes.
16278608|NCT00801931|Drug|Cyclophosphamide|Cyclophosphamide should be infused over one hour. The drug can be diluted in D5W, NS, or other solutions (100-250 mL) to a maximum concentration of 20 mg/mL.
16278609|NCT00801931|Drug|Horse Antithymocyte Globulin|Horse Antithymocyte Globulin (ATG [horse]) will be diluted in 0.9% sodium chloride or 0.45% sodium chloride for IV infusion (through an inline filter with pore size of 0.2 micrometer) to a concentration of 1-4 mg/ml and infused through a central venous catheter over 8 hours in Regimen E.
16278610|NCT00801931|Drug|Rabbit Antithymocyte Globulin|Rabbit Anti-Thymocyte Globulin (rabbit ATG) will be diluted in 0.9% sodium chloride or D5W for IV infusion (through an in-line filter with pore size of 0.22 micrometer) to a concentration of 0.5 mg/ml and infused through a central venous catheter over 8 hours for all doses on Days -4, -3, -2, and -1 in Regimens A, B, D and F.
16278611|NCT00801931|Drug|Thiotepa|Thiotepa should be diluted in NS (1-5 mg/ml) and infused over 2 hrs on Days -8, -4. IV fluids should be at maintenance rate (1500 ml/m2).
16278612|NCT00801918|Drug|Denileukin Diftitox|Denileukin Diftitox: 18 mcg/kg/day: days 1-5 in cycles 1,2,3,4
16278613|NCT00801918|Drug|Denileukin diftitox, ifosfamide, cyclophosphamide, etoposide|Denileukin Diftitox: 18 mcg/kg/day days 1-2 in cycles 5 and 6 Ifosfamide: 3000mg/m²/IV/d X 3 days + Mesna 3000 mg/m2/d X 3 days Carboplatin: 635mg/m2/d X 1 day Etoposide: 100mg/m2/d X 3 days
16278614|NCT00801905|Drug|Nepafenac|Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.
16278615|NCT00801905|Other|Lubricant|Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed
16278616|NCT00801892|Device|Continuous Positive Airway Pressure (CPAP)|Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
16278617|NCT00801892|Device|Sham- Continuous Positive Airway Pressure (Sham-CPAP)|Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
16278618|NCT00801879|Drug|Mupirocin calcium ointment, 2%|0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
16278619|NCT00801879|Drug|Placebo ointment|Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
16278620|NCT00801866|Drug|Bevacizumab|Intravitreal administration
16278621|NCT00801866|Procedure|Panretinal Photocoagulation|Panretinal Photocoagulation
16278622|NCT00801853|Drug|Aerovant|Aerovant 1mg bid (dry powder)
16278623|NCT00801853|Drug|Aerovant|Aerovant 3mg bid (dry powder)
16278624|NCT00801853|Drug|Aerovant|Aerovant 10mg bid (dry powder)
16278625|NCT00801853|Other|placebo|placebo control (dry powder)
16278626|NCT00801827|Drug|F-18 (fallypride)|Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
16278627|NCT00801814|Dietary Supplement|PolyGlycopleX (PGX)|2.5 grams of PGX
16278628|NCT00801814|Dietary Supplement|PolyGlycopleX (PG)|5.0 grams of PGX
16278629|NCT00801814|Dietary Supplement|PolyGlycopleX|7.5 grams of PGX
16278630|NCT00801814|Dietary Supplement|Control|0g of PGX
16278631|NCT00801814|Dietary Supplement|Second Control|0g of PGX
16278682|NCT00801463|Drug|tripterygium wilfordii (TW)|Pre 30mg/d +TW 120 mg/d, po for 12 weeks
16278683|NCT00801450|Drug|Triamcinolone acetonide|4 mg
16278684|NCT00801450|Drug|Triamcinolone acetonide|40 mg
16278685|NCT00801437|Drug|Xalacom|Xalacom 1 drop into the affected eye daily
16278632|NCT00801801|Drug|Docetaxel + Sorafenib|Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent.
16278633|NCT00801788|Drug|Oxycodone hydrochloride|Extended release tablet
16278634|NCT00801788|Drug|Oxycodone hydrochloride|Extended release tablet
16278635|NCT00801762|Device|Fibered confocal microscope|
16278636|NCT00801749|Behavioral|sleep|
16278637|NCT00801736|Drug|Cisplatin, Paclitaxel|"Cisplatin 75mg/m2, Day 1
~Paclitaxel 175mg/m2, Day 1"
16278638|NCT00801723|Drug|Budesonide MMX 6 mg Tablet|Budesonide MMX 6 mg Tablet once daily.
16278639|NCT00801723|Drug|Placebo Tablet|Placebo Tablet once daily.
16278640|NCT00801710|Device|BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)|"Revascularization of coronary artery chronic total occlusion.
~Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant"
16278641|NCT00801697|Biological|DNA Vaccine|4 mg VRC-HIVDNA044-00-VP administered as 1 mL
16278642|NCT00801697|Biological|DNA Vaccine placebo|1 mL VRC-PBSPLA043-00-VP
16278643|NCT00801697|Biological|rAd35|VRC-HIVADV027-00-VP 1 x 10^10 PU administered as 1 mL
16278644|NCT00801697|Biological|rAd35 placebo|1 mL VRC-PBSPLA043-00-0VP
16278645|NCT00801697|Biological|rAd5|4 mg VRC-HIVADV038-00-VP administered as 1 mL
16278646|NCT00801697|Biological|rAd5 placebo|1 mL VRC-DILUENT013-DIL-VP
16278647|NCT00801684|Drug|Placebo|Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.
16278648|NCT00801684|Drug|TrIP-2D|Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
16278649|NCT00801684|Drug|TrIP-2SS|Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
16278650|NCT00801684|Drug|TrIP-2D|Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
16278651|NCT00801684|Drug|TrIP-2SS + Foradil|Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
16278652|NCT00801671|Procedure|cPAP|After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
16278653|NCT00801658|Device|selective Laser Trabeculoplasty (SLT)|
16278654|NCT00801645|Behavioral|Exercise|The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.
16278655|NCT00801632|Procedure|Kidney Transplantation|Surgical transplantation of donor kidney
16278656|NCT00801632|Procedure|Bone marrow transplantation|During kidney transplant, bone marrow cells donated by the same donor as the kidney are given through a plastic tube placed in a vein in the chest, underneath the collarbone
16278657|NCT00801632|Biological|MEDI-507|0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1
16278658|NCT00801632|Drug|cyclophosphamide|60 mg/kg infusion on days -5, -4
16278659|NCT00801632|Biological|rituximab|375 mg/m^2 infusion on days -7, -2, 5, and 12
16278660|NCT00801632|Drug|Tacrolimus|0.05 mg/kg intravenously twice daily starting on day -1, adjusted to trough level of 10-15ng/ml, then tapered (if eligible) on days 1, 7, 14, 21, 28, 42, and 56
16278661|NCT00801632|Drug|corticosteroids|2 mg/kg prednisone on day 4, with an additional 500-mg pulse of methylprednisolone given on days 10, 11, and 12, and then tapered off by day 20
16278662|NCT00801632|Radiation|thymic irradiation|700 cGy of thymic irradiation administered in a single dose on day -1
16278663|NCT00801606|Drug|Zinc|Zinc 20 mg/day
16278664|NCT00801606|Drug|Micronutrient without zinc|Multimineral 2 RDA
16278665|NCT00801606|Drug|Micronutrient with zinc|Multimineral 2 RDA and zinc 20 mg per day
16278666|NCT00801606|Drug|Placebo|Placebo
16278667|NCT00801593|Procedure|Steroid injection into the TMJs.|In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.
16278668|NCT00801580|Drug|doxorubicin liposomal|"Cyclophosphamide
~Mesna
~Methotrexate
~Doxorubicin liposomal
~Vincristine
~Dexamethasone
~Rituximab
~Cytarabine"
16278669|NCT00801567|Device|Magnetic resonance spectroscopy (MRS)|90-minute magnetic resonance scan.
16278670|NCT00801528|Drug|Ropivacaine, Diclofenac, Water for injection|Ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection) or water for injection will be administered as a constant instillation rate set of 10 mL/hr for the subsequent 18 postoperative hours.
16278671|NCT00801515|Drug|Maraviroc|150 mg twice per day
16278672|NCT00801502|Dietary Supplement|Oily fish consumption|Two portions of salmon per week from week 20 of pregnancy until giving birth
16278673|NCT00801502|Other|Control|No change to habitual diet from week 20 of pregnancy until giving birth
16278681|NCT00801476|Procedure|Pre-operative bilateral breast MRI|After the standard mammogram and ultrasound testing, the surgeon is asked which surgical procedure they feel is appropriate for the patient. A bilateral breast MRI is then performed prior to surgery. The surgeon is again asked which surgery they feel is appropriate based on the new information provided by the MRI. The study is trying to see if this pre-operative breast MRI helps define the tumour leading to a better first surgical decision.
16278686|NCT00801424|Device|humidified warmed CO2|Additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity
16278687|NCT00801411|Drug|cyclophosphamide|Given IV
16278688|NCT00801411|Drug|docetaxel|Given IV
16278689|NCT00801411|Drug|doxorubicin hydrochloride|Given IV
16278690|NCT00801398|Drug|Oxymorphone IR|Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
16278691|NCT00801385|Drug|erlotinib hydrochloride|
16278692|NCT00801385|Drug|sorafenib tosylate|
16278693|NCT00801385|Genetic|DNA analysis|
16278694|NCT00801385|Genetic|mutation analysis|
16278695|NCT00801385|Genetic|polymerase chain reaction|
16278696|NCT00801385|Genetic|protein analysis|
16278697|NCT00801385|Genetic|protein expression analysis|
16278698|NCT00801385|Other|immunohistochemistry staining method|
16278699|NCT00801385|Other|laboratory biomarker analysis|
16278700|NCT00801359|Procedure|Phacoemulsification|
16278701|NCT00801359|Drug|BSSPlus solution|
16278702|NCT00801359|Drug|Lactated Ringer's solution|
16278703|NCT00801346|Other|laboratory biomarker analysis|
16278704|NCT00801346|Other|metabolic assessment|
16278705|NCT00801346|Other|questionnaire administration|
16278706|NCT00801346|Procedure|assessment of therapy complications|
16278707|NCT00801346|Procedure|fatigue assessment and management|
16278708|NCT00801346|Procedure|quality-of-life assessment|
16278709|NCT00801320|Procedure|Tumor collection|Tumor collected at the time of planned surgery
16278710|NCT00801307|Device|spirometer|According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.
16278711|NCT00801294|Drug|BIBF 1120 and BIBW 2992|
16278712|NCT00801281|Drug|Rituximab|Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.
16278713|NCT00801281|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.
16278714|NCT00801281|Drug|Doxorubicin|Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.
16278715|NCT00801281|Drug|Vincristine|Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.
16278716|NCT00801281|Drug|Prednisone 1|Prednisone 100 mg p.o. d. 1-5 q. 21 d.
16278717|NCT00801281|Drug|Prednisone 2|Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.
16278718|NCT00801268|Drug|tripterygium wilfordii|TW，60mg/d
16278719|NCT00801268|Drug|Emodin|100mg/d
16278720|NCT00801255|Drug|RO5024048|500mg po bid/100mg po q8h for 7 days
16278721|NCT00801255|Drug|danoprevir|500mg po bid/100mg po q8h for 14 days
16278722|NCT00801255|Drug|danoprevir|1000mg po bid/100mg po q8h for 14 days\n500mg po bid/200mg po q8h for 14 days
16278723|NCT00801255|Drug|danoprevir|1000mg po bid/200mg po q8h for 14 days
16278724|NCT00801255|Drug|danoprevir|1000mg/600mg po twice daily for 14 days
16278725|NCT00801255|Drug|danoprevir|1000mg/900mg po twice daily for 14 days
16278726|NCT00801242|Drug|Degarelix 240 mg / 80 mg|For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
16278727|NCT00801229|Drug|Vyvanse|Vyvanse 30, 50, or 70 mg daily
16278728|NCT00801229|Drug|Placebo|Placebo 30, 50, 70 mg daily
16278729|NCT00801216|Drug|High-dose sequential chemotherapy and autologous transplant|Two courses of methotrexate 3.5 g/mq day 1 and cytarabine 2 g/mq twice a day, for two days, Rituximab 375 mg/mq days 3 & 11 and Intrathecal liposomal cytarabine 50 mg day 6(Phase I) followed in case of response by cyclophosphamide 7 g/mq plus Rituximab 375 mg/mq and Intrathecal liposomal cytarabine 50 mg Leukapheresis A and cryopreservation (Phase II), Cytarabine 2 g/mq twice a day for 4 days, Rituximab 375 mg/m2 and Reinfusion of stem cells (Phase III), etoposide 2 g/mq, Intrathecal liposomal cytarabine 50 mg (Phase IV) and high-dose Thiotepa-BCNU supported by autologous stem cell transplant (Phase V), and whole-brain radiotherapy in patients who do not achieve a complete remission after chemotherapy (Phase VI)
16278730|NCT00801203|Drug|IRCT|Up to two administrations of the IRCT during a single cough testing session
16278731|NCT00801190|Other|HES (130/0.4)|33 ml/kg i.v. during surgery
16278732|NCT00801190|Other|Ringer's Lactate|33 ml/kg i.v.
16278733|NCT00801177|Biological|IMC-11F8|"Cohort 1
~100 mg I.V."
16278734|NCT00801177|Biological|IMC-11F8|"Cohort 2
~200 mg I.V."
16278735|NCT00801177|Biological|IMC-11F8|"Cohort 3
~400 mg I.V."
16278736|NCT00801177|Biological|IMC-11F8 I.V.|"Cohort 4
~600 mg I.V."
16278737|NCT00801177|Biological|IMC-11F8|"Cohort 5
~800 mg I.V."
16278738|NCT00801177|Biological|IMC-11F8|"Cohort 6
~1000 mg I.V."
16278739|NCT00801177|Biological|IMC-11F8|"Cohort 1
~100 mg I.V."
16278740|NCT00801177|Biological|IMC-11F8|"Cohort 2
~200 mg I.V."
16278741|NCT00801177|Biological|IMC-11F8|"Cohort 3
~400 mg I.V."
16278742|NCT00801177|Biological|IMC-11F8|"Cohort 4
~600 mg I.V."
16278743|NCT00801177|Biological|IMC-11F8|"Cohort 5
~800 mg I.V."
16278744|NCT00801177|Biological|IMC-11F8|"Cohort 6
~1000 mg I.V."
16278745|NCT00801164|Drug|Frio Mouth Rinse Placebo|Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
16278746|NCT00801164|Drug|Frio Mouth Rinse|Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
16278747|NCT00801151|Drug|Zolinza (vorinostat), vinorelbine|"Vorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration.
~Barring dose limiting toxicities the dose of vorinostat will escalate in several steps (300 mg po qd 7/21 days, 300 mg po qd 21/21 days, 400 mg po qd 7/21 days, 400 mg po qd 21/21 days).
~Patients may receive a maximum of 6 cycles of study medication."
16278748|NCT00801138|Drug|saline|2 ml 0.9% saline (placebo)
16278749|NCT00801138|Drug|Dexamethasone|dexamethasone 8 mg (2 ml)
16278750|NCT00801138|Drug|ropivacaine|30 ml 0.5% ropivacaine
16278751|NCT00801138|Drug|Bupivacaine|30 ml 0.5% bupivacaine
16278752|NCT00801125|Drug|natalizumab|
16278753|NCT00801099|Drug|Amoxicillin/Clavulanic Acid|single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
16278754|NCT00801086|Drug|7% (w/v) Tempol alcohol-based gel (MTS-01)|200mL gel applied daily prior to radiation dose and removed immediately thereafter.
16278755|NCT00801086|Drug|alcohol-based gel|200mL gel applied daily prior to radiation dose and removed immediately thereafter
16278756|NCT00801073|Procedure|Human Amniotic Membrane Transplantation|Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease
16278757|NCT00801060|Drug|Lumiliximab + FCR|Dose, schedule, and duration in the protocol
16278758|NCT00801060|Drug|FCR|Dosage, schedule, and duration in the protocol
16278759|NCT00801047|Drug|Bupivacaine epidural|Bupivacaine 0.1%, fentanyl 1 mic/kg
16278760|NCT00801047|Drug|Remifentanil|40-50 mic per 1-2 min via PCA
16278761|NCT00801034|Drug|Calcium|tablets, 1 tablet 2 times per day in 28 days
16278762|NCT00801034|Drug|Potassium|Tablets, 5 tablets 2 times per day for 28 days
16278763|NCT00801021|Drug|Frio Mouth Rinse|Rinse with 15ml twice daily then expectorate
16278764|NCT00801008|Behavioral|Exercise and relaxation intervention|Comparison of an exercise and relaxation intervention to a wait-list control condition
16278765|NCT00800995|Dietary Supplement|SOD|
16278766|NCT00800995|Dietary Supplement|Sham|
16278767|NCT00800982|Procedure|Narrow band (310-312 nm) ultraviolet light B phototherapy|Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff
16278768|NCT00800982|Drug|etanercept|Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
16278769|NCT00800969|Procedure|FDG-PET-CT|Radiologic standard procedure
16278770|NCT00800956|Drug|[14C]-esreboxetine|Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
16278771|NCT00800943|Biological|Alemtuzumab (Campath-1H)|Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks
16278772|NCT00800930|Biological|Sodium Butyrate|Patients will be instructed to lie on a bed (cholera cot) in left lateral position. A soft rectal catheter will be introduced by a nurse/physician, through which 80 ml of butyrate solution will be instilled slowly with a 50 ml plastic syringe. Patients will be asked to retain the enema for at least ½ hour by remaining supine for 30 minutes after the administration. However, if a patient cannot retain the enema for 30 minutes, he will be given a second round of enema immediately after defecation.
16278773|NCT00800930|Biological|Saline|Patients will be instructed to lie on a bed (cholera cot) in left lateral position. A soft rectal catheter will be introduced by a nurse/physician, through which 80 ml of saline solution will be instilled slowly with a 50 ml plastic syringe. Patients will be asked to retain the enema for at least ½ hour by remaining supine for 30 minutes after the administration. However, if a patient cannot retain the enema for 30 minutes, he will be given a second round of enema immediately after defecation.
16278774|NCT00800917|Drug|Temsirolimus|25 mg weekly IV
16278775|NCT00800917|Drug|Bevacizumab|10 mg/kg every 2 weeks
16278776|NCT00800865|Other|Biomarker sample collection before and after dosing with cytotoxic agent(s)|Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).
16278777|NCT00800865|Other|Biomarker sample collection before and after dosing with cytotoxic agent(s)|A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
16278778|NCT00800839|Drug|Busulfan|Starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.
16278779|NCT00800839|Drug|Fludarabine|Dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.
16278780|NCT00800839|Drug|Cyclophosphamide|Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
16278781|NCT00800826|Drug|dexmedetomidine|
16278782|NCT00800813|Behavioral|Penile Exam, Peyronie's Plaque and Erectile function assessment|"At the baseline visit, the patient's co-morbidities, height, weight with calculation of body mass index will be documented.
~After surgery, the patient will be instructed to keep a diary to record erectile function including how often they use a PDE-5 inhibitor or injection therapy and each time they get an erection and the level of rigidity. The diary is required to document PDE-5 inhibitor and injection therapy use and response in each sexual encounter, unlike the IIEF questionnaire, which addresses erectile function over a 4-week period. Accurate documentation is essential for erectile function assessment, as patient choice of erectile function medication may differ in each sexual encounter, and accordingly, the achieved rigidity level."
16278783|NCT00800800|Drug|Rosuvastatin|40 mg, oral, single dose
16278784|NCT00800800|Drug|Placebo|oral, single dose
16278785|NCT00800787|Biological|Nabi-HB|"Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously.
~Dosage will be according to each patients body weight, as follow:
~< 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly"
16278786|NCT00800774|Procedure|LASIK|Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
16278787|NCT00800761|Drug|Deferoxamine and Deferiprone|comparison of two arms: the first one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die plus deferiprone tablets 75 mg/kg three times/die versus the second one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die
16278788|NCT00800761|Drug|Deferoxamine|deferoxamine vials,40 mg/kg,12 hours/die
16278937|NCT00799669|Other|preventive intervention|
16278789|NCT00800748|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
16278790|NCT00800748|Drug|Ribavirin|Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
16278791|NCT00800735|Drug|Pegylated-interferon alfa-2a|Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
16278792|NCT00800735|Drug|Ribavirin|Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing < 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
16278793|NCT00800722|Drug|Rapamycin Treatment of Port Wine Stain|Treatment of Port Wine Stain
16278794|NCT00800709|Drug|Memantine|Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day
16278795|NCT00800696|Procedure|oral care|The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx
16278796|NCT00800683|Drug|BI 1356|BI 1356 dosed once daily
16278797|NCT00800683|Drug|placebo|placebo matching BI 1356 taken once daily
16278798|NCT00800670|Biological|Ad5Ag85A|Single intra-muscular administration of 10^8 pfu of recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)
16278799|NCT00800670|Biological|Ad5Ag85A|Single intra-muscular administration of 10^9 recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)
16278800|NCT00800657|Procedure|Pacing and Stem Cells Implantations.|Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
16278801|NCT00800657|Procedure|Pacing and Stem Cells Implantation|Pacing and Stem Cells Implantation.
16278802|NCT00800644|Procedure|CT or MRI + Blood Test|"During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
~Blood (about 1 tablespoon) will be drawn to test for bone turnover."
16278803|NCT00800618|Drug|PF-02413873 100 mg QD|100 mg of PF-02413873 oral suspension once daily for 14 days
16278804|NCT00800618|Drug|PF-02413873 1500 mg QD|1500 mg of PF-02413873 oral suspension once daily for 14 days
16278805|NCT00800618|Drug|PF-02413873 20 mg QD|20 mg of PF-02413873 oral suspension once daily for 14 days
16278806|NCT00800618|Drug|PF-02413873 500 mg QD|500 mg of PF-02413873 oral suspension once daily for 14 days
16278807|NCT00800618|Drug|PF-02413873 Placebo|PF-0241383 Placebo once daily for 14 days
16278808|NCT00800605|Biological|Vero cell-derived, trivalent, seasonal influenza vaccine|Single intramuscular injection
16278809|NCT00800605|Biological|Placebo: Phosphate-buffered saline|Single intramuscular injection
16278810|NCT00800592|Drug|sildenafil|10 mg sildenafil bolus
16278811|NCT00800579|Drug|GS-9411|Inhaled GS-9411 dissolved in sterile saline
16278812|NCT00800579|Drug|Placebo|Inhaled volume-matched placebo in sterile saline
16278813|NCT00800566|Drug|Oral Clofarabine|The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.
16278814|NCT00800553|Drug|donepezil|5mg o.m. p.o. for approx. 2 weeks
16278815|NCT00800553|Drug|Placebo|5mg of placebo for approx. 2 weeks
16278816|NCT00800540|Drug|Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension|Fixed combination ophthalmic suspension
16278817|NCT00800540|Drug|Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution|Fixed combination ophthalmic solution
16278818|NCT00800527|Drug|Gabapentin|Gabapentin 800 mg one a day up to 30 day
16278819|NCT00800527|Drug|Diclofenac|Diclofenac 75 mg one a day up to 30 day
16278820|NCT00800514|Drug|amantadine|amantadine twice daily
16278821|NCT00800514|Drug|amantadine|amantadine 100 mg twice daily
16278822|NCT00800501|Drug|sNN0029|Continuous ICV infusion at one of three dose levels
16278823|NCT00800501|Drug|Placebo|Continuous ICV infusion
16278824|NCT00800475|Drug|Gemfibrozil Tablets|
16278825|NCT00800462|Drug|Oxybutynin Cl|15 mg qd for 3 months
16278826|NCT00800462|Drug|Trospium Cl|20mg bid for 3 months
16278827|NCT00800462|Drug|Darifenacin Hydrogen Bromide (HBr)|15 mg qd for 3 months
16278828|NCT00800436|Drug|Herceptin|Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.
16278829|NCT00800423|Drug|Brimonidine Tartrate 0.2%|"Brimonidine Tartrate 0.2% drops
~1 drop twice a day for 1 month in the operated eye"
16278830|NCT00800423|Drug|Timolol maleate 0.5%|"timolol maleate 0.5% drops
~1 drop twice a day for 1 month in the operated eye"
16278831|NCT00800410|Behavioral|Community Health Worker (CHW) services|CHW services included access to an 11 week healthy lifestyle education curriculum, two home visits per month, two additional phone contacts per month, and accompanied participants to one clinic visit within the six month intervention period
16278832|NCT00800384|Device|Implantable defibrillator|Implantable defibrillator to detect and terminate ventricular arrhythmias
16278833|NCT00800371|Procedure|intra-articular steroid injection|Steroid injection into otherwise noncontrollable arthritis.
16278834|NCT00800358|Drug|Paricalitol|oral paricalcitol variable daily dosing based on intact PTH level for 6 months
16278835|NCT00800358|Drug|Calcitriol|oral calcitriol variable daily dosing based on intact PTH level for 6 months
16278836|NCT00800345|Drug|Oral Topotecan|Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
16278837|NCT00800345|Drug|Pazopanib|Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth.
16278838|NCT00800332|Drug|CYT003-QbG10|subcutaneous injection
16278839|NCT00800332|Drug|Placebo|subcutaneous injection
16278840|NCT00800319|Drug|RDC-0313|Oral solution given in 5, 15, 25, 50, and 75 mg single doses
16278841|NCT00800319|Drug|Placebo|Volume matched placebo; oral solution; single dose
16278938|NCT00799669|Other|questionnaire administration|
16278842|NCT00800306|Drug|Levosimendan|Intravenous administration of Levosimendan 0,2 µg•kg-1•min-1 for 24 hrs followed by the addition of 35 ppm of inhaled nitric oxide
16278843|NCT00800306|Drug|dobutamine|Intravenous administration of dobutamine 5 µg•kg-1•min-1 for 36 hrs. At the end of the first 24 hrs drug infusion, inhaled nitric oxide at the concentration of 35 ppm will be added for further 12 hrs.
16278845|NCT00800280|Drug|PD 0332334|Single 300 mg dose of PD 0332334 immediate release capsules administered orally
16278846|NCT00800280|Drug|PD 0332334|Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
16278847|NCT00800280|Drug|cimetidine|600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
16278848|NCT00800267|Drug|latanoprost 0.005%|placebo in the morning and latanoprost .005% in the evening
16278849|NCT00800267|Drug|fixed combination latanoprost-timolol|one drop in the morning and placebo in the evening
16278850|NCT00800267|Drug|timolol 0.5%|one drop in the morning and evening
16278851|NCT00800254|Device|Neuromuscular Electrical Stimulation (NMES)|NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
16278852|NCT00800254|Other|Standard Rehabilitation Protocol|Standard physical therapy for 8 weeks after surgery
16278853|NCT00800215|Drug|iv SPM 927 and oral placebo tablet|60-minute infusion iv SPM 927 and oral placebo tablet
16278854|NCT00800215|Drug|oral SPM 927 tablet and iv placebo|60-minute infusion placebo and oral SPM 927 tablet
16278855|NCT00800215|Drug|iv SPM 927 and oral placebo tablet|30-minute infusion iv SPM 927 and oral placebo tablet
16278856|NCT00800215|Drug|oral SPM 927 tablet and iv placebo|30-minute infusion placebo and oral SPM 927 tablet
16278857|NCT00800202|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
16278858|NCT00800202|Drug|carboplatin|AUC6 iv every 3 weeks for 6 cycles
16278859|NCT00800202|Drug|erlotinib [Tarceva]|150mg/day po
16278860|NCT00800202|Drug|paclitaxel|200mg/m2 iv every 3 weeks for 6 cycles
16278861|NCT00800189|Radiation|Anterior electronic portal images (EPI)|EPI's are taken for the first three consecutive days of treatment to detect set-up errors.
16278862|NCT00800176|Drug|Placebo|po daily for 12 weeks
16278863|NCT00800176|Drug|RO4998452|2.5mg po daily for 12 weeks
16278864|NCT00800176|Drug|RO4998452|5mg po daily for 12 weeks
16278865|NCT00800176|Drug|RO4998452|10mg po daily for 12 weeks
16278866|NCT00800176|Drug|RO4998452|20mg po daily for 12 weeks
16278867|NCT00800176|Drug|RO4998452|40mg po daily for 12 weeks
16278868|NCT00800163|Other|ED Activation/Immediate Transfer|ED Physician Activation and Immediate Transfer Protocol - see Circulation. 2007;116:67-76
16278869|NCT00800150|Drug|fludarabine phosphate|
16278870|NCT00800150|Drug|melphalan|
16278871|NCT00800150|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16278872|NCT00800150|Radiation|intensity-modulated radiation therapy|
16278873|NCT00800150|Radiation|tomotherapy|
16278874|NCT00800150|Radiation|total marrow irradiation|
16278875|NCT00800150|Radiation|total nodal irradiation|
16278876|NCT00800137|Drug|low molecular weight heparin or unfractionated heparin|"For elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure.
~Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6.
~Last dose given in the morning(ie. > 24 hours)of the day prior to the procedure.
~Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure.
~Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery."
16278877|NCT00800137|Drug|Warfarin or coumadin|Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0
16278878|NCT00800124|Procedure|cemented Landos prosthesis vs. uncemented Landos prosthesis|randomization between the cemented and non-cemented prosthesis.
16278879|NCT00800111|Procedure|endothelial keratoplasty|Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).
16278880|NCT00800098|Drug|herbal topical cream|
16278881|NCT00800085|Drug|glucose 20%|maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
16278882|NCT00800072|Device|NOWOX|one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours
16278883|NCT00800059|Radiation|Total Marrow Irradiation|Total Marrow Irradiation delivered by chemotherapy delivered to cohorts of patients in a dose escalation. The initial cohort will receive 14 Gy. If tolerated subsequent cohorts will receive an additional 2 Gy until the maximum tolerated dose or 28 Gy is reached.
16278884|NCT00800046|Device|AccuCinch® Ventriculoplasty System|Mitral valve repair due to functional disease
16278885|NCT00800033|Behavioral|Aerobic exercise training|Walking, jogging, rowing, cycling to be done 5 times per week for 45 minutes per session (3 supervised sessions, 2 sessions at home) for 5 months
16278886|NCT00800033|Dietary Supplement|pulse based diet|Two pulse-based meals per day (lentils, beans, chickpeas, or peas) for 2 months, followed by 1-month washout and then a normal diet for 2 months (order of diets is randomized)
16278887|NCT00800007|Drug|ANZ-521|3x10^7 cfu or 3x10^8 cfu ANZ-521 in 250 mL, IV over 2 hours, every 28 days for up to 3 doses.
16278888|NCT00800007|Drug|Placebo|250 mL normal saline, IV over 2 hours, every 28 days for up to 3 doses.
16278889|NCT00799981|Device|A=SpeediCath Compact 7 cm and B=POBE 10 cm|Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
16278890|NCT00799968|Drug|Urokinase|UK,bolus 4 400 U/kg followed by intravenous 2 200 U/kg•h for 12 hours
16278891|NCT00799968|Drug|Urokinase|UK,20 000U/kg continuously intravenous infusion for 2 hours
16278892|NCT00799955|Procedure|Placebo block|100 micrograms of spinal morphine
16278893|NCT00799955|Procedure|Ultrasound-guided TAP block|1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected into the transversus abdominis plane, on each side
16278894|NCT00799942|Drug|Neramexane mesylate|open-label treatment of 36 months Neramexane mesylate up to 75 mg per day
16278895|NCT00799929|Other|in vitro fertilization (IVF/ICSI)|
16278896|NCT00799916|Drug|Resuscitation (Voluven)|Resuscitation aimed at venous oxygen saturation higher than 70%
16278897|NCT00799916|Drug|Resuscitation (Saline)|Resuscitation aimed at venous oxygen saturation higher than 70%
16278898|NCT00799903|Drug|Darapladib|Lp-PLA2 inhibitor administered in addition to standard therapy
16278899|NCT00799903|Drug|Placebo|Placebo administered in addition to standard therapy
16278900|NCT00799890|Drug|Sunphenon EGCG|200-800mg (1-4 capsules)
16278901|NCT00799890|Drug|Placebo|1-4 capsules
16278908|NCT00799851|Device|Variceal band ligation|
16278909|NCT00799851|Drug|cyanoacrylate injection|cyanoacrylate injection
16278910|NCT00799838|Drug|Ketoprofen|"Formulation: oral solution 20mg/mL
~Route of administration: oral
~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d"
16278911|NCT00799838|Drug|Placebo (for Ketoprofen)|"Formulation: oral solution
~Route of administration: oral
~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d"
16278912|NCT00799838|Drug|Amoxicillin|"Formulation: suspension 125mg/5 mL
~Route of administration: oral
~Dose regimen: 20-40mg/Kg/day administered t.i.d"
16278913|NCT00799825|Biological|GSK Biological's HPV vaccine GSK580299 (Cervarix™)|All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
16278914|NCT00799812|Drug|CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).|3 swabsticks topically applied at the same time to intact skin
16278915|NCT00799812|Drug|CHG 2% w/v & IPA 70% v/v swab applied sequentially|Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
16278916|NCT00799812|Drug|Aqueous CHG 4% w/v applied according to mfr's directions|Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
16278917|NCT00799812|Other|Sterile swabstick with sterile water (3 @ once)|3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
16278918|NCT00799812|Other|Sterile swabstick with sterile water (one-at-a-time)|Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
16278919|NCT00799799|Biological|NK cells|NK cells infusion after immunosuppressive chemotherapy
16278920|NCT00799786|Behavioral|Building Better Caregivers Online Workshop|
16278921|NCT00799773|Drug|Rituximab|Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses
16278922|NCT00799773|Procedure|Plasma exchange|Target volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have improved.
16278923|NCT00799773|Drug|Corticosteroids|1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped
16278924|NCT00799760|Drug|oseltamivir + zanamivir|oral oseltamivir 75mg twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 days
16278925|NCT00799760|Drug|oseltamivir + zanamivir's placebo|oral oseltamivir 75mg twice daily+ placebo inhaled by mouth twice daily during 5 day
16278926|NCT00799760|Drug|oseltamivir's placebo + zanamivir|oral placebo twice daily + zanamivir 10 mg inhaled by mouth twice daily during 5 day
16278927|NCT00799747|Drug|AZD4017|ascending single doses (start dose 2 mg), oral suspension
16278928|NCT00799747|Drug|Placebo|placebo
16278929|NCT00799734|Drug|EXD|Interventions: Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day and placebo therapy of 15g granules with similar colour and taste.
16278930|NCT00799708|Drug|Comparator: placebo|placebo capsule once daily for 7 days.
16278931|NCT00799708|Drug|Comparator: Estrace|Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
16278932|NCT00799695|Behavioral|phone call contact|A sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams
16278933|NCT00799682|Drug|Xalatan|0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
16278934|NCT00799682|Drug|Travatan Z|0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
16278935|NCT00799669|Behavioral|smoking cessation intervention|Standard quit-smoking counseling to help decrease their risk of cancer.
16278936|NCT00799669|Other|counseling intervention|Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.
16278939|NCT00799656|Drug|ataciguat (HMR1766)|oral administration 200mg once daily for 28 days
16278940|NCT00799656|Drug|placebo|oral administration once daily for 28 days
16278941|NCT00799643|Drug|Salsalate|Salsalate 3.5 g/d orally, divided dosing
16278942|NCT00799643|Drug|Salsalate Placebo|
16278943|NCT00799630|Dietary Supplement|Carbohydrate drink|Maltodextrins, dextrose, fructose, amino acids (leucine, isoleucine, valine), natural flavors, sodium chloride, magnesium citrate, zinc, lactate, acid: malic acid, anti-caking agent: silicon dioxide; Curcumin (turmeric extract) , Thickener: xanthan gum, caffeine, vitamin C (Acerola extract), vitamin E - B1 - B2 - B3; piperine (black pepper extract).
16278944|NCT00799617|Drug|AndroGel® (testosterone gel)|Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.
16278945|NCT00799617|Drug|Placebo|Testosterone levels will be measured at regular intervals.
16278946|NCT00799604|Drug|clevidipine|Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).
16278947|NCT00799591|Other|Observational study so no intervention in the patient.|Observational study so no intervention in the patient.
16278948|NCT00799578|Drug|Cysteamine|Drug is in enteric-coated capsule form. The dosage will begin at 1g/m-squared body surface area with a maximum dose of 1000mg twice daily. Treatment period is 3-6 months.
16278949|NCT00799565|Genetic|catch of blood|"4 tubes of blood are taken on subjects. Samples are sent in Pr Jeunemaître to extract DNA and stock it.
~This DNA bank aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects"
16278950|NCT00799552|Drug|RX-10045|RX-10045 eye drop
16278951|NCT00799552|Drug|Placebo|Placebo eye drop
16278952|NCT00799539|Drug|bortezomib|From cycles 1-4, 1.3mg/m^2 on days 1,4,8,11,22,25,29,and 32 of each 6-week cycle
16278953|NCT00799539|Drug|bortezomib|From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
16278954|NCT00799539|Drug|melphalan|9 mg/m^2 once daily on days 1-4 of each 6-week cycle
16278955|NCT00799539|Drug|prednisone|60 mg/m^2 once daily on days 1-4 of each 6-week cycle
16278956|NCT00799526|Procedure|Autologous Ex Vivo Conjunctival for Symblepharon Transplantation|Safety and efficacy of conjunctival ex vivo for reconstruction of the ocular surface.
16278957|NCT00799526|Procedure|Ex Vivo Conjunctival for Symblepharon Transplantation|The safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface with symblepharon.
16278958|NCT00799513|Drug|Lenalidomide|single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
16278959|NCT00799500|Other|Screening|Weekly vaginal pH
16278960|NCT00799487|Drug|CONCERTA (methylphenidate HCl) or placebo|Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2
16278961|NCT00799487|Drug|CONCERTA (methylphenidate HCl) or placebo|Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1
16278962|NCT00799461|Other|internet-based intervention|Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
16278963|NCT00799461|Other|questionnaire administration|Completion of questions in an online format
16278964|NCT00799461|Procedure|psychosocial assessment and care|Assessment and care of psychosocial aspects
16278965|NCT00799461|Procedure|assessment of therapy complications|Evaluation of complications of treatment
16278966|NCT00799461|Procedure|management of therapy complications|Managing therapy complications
16278967|NCT00799461|Procedure|fatigue assessment and management|Assessing and managing fatigue
16278968|NCT00799461|Other|counseling intervention|Counseling provided via telephone
16278969|NCT00799448|Drug|repaglinide|
16278970|NCT00799448|Drug|biphasic human insulin 30|
16278971|NCT00799448|Drug|insulin NPH|
16278972|NCT00799435|Drug|Exenatide|5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks
16278973|NCT00799422|Device|Complete Easy Rub|Commercially marketed contact lens solution for contact lens care
16278974|NCT00799422|Device|ReNu MultiPlus|Commercially marketed contact lens solution for contact lens care
16278975|NCT00799422|Device|Clear Care|Commercially marketed contact lens solution for contact lens care
16278976|NCT00799422|Device|Contact lenses|Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.
16278977|NCT00799409|Drug|Placebo/ CONCERTA (methylphenidate HCl)|Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2
16278978|NCT00799409|Drug|CONCERTA (methylphenidate HCl) / Placebo|Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2
16278979|NCT00799396|Drug|Clopidogrel|300 mg on first day, then 75 mg per day for the next 6 days
16278980|NCT00799396|Drug|Aspirin|Single dose of 324 mg on the last day of clopidogrel treatment
16278981|NCT00799383|Drug|Calcium and Vitamin D|Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
16278982|NCT00799383|Other|Placebo|
16278983|NCT00799370|Procedure|Early weight bearing|Weight bearing performed immediately after surgery
16278984|NCT00799370|Procedure|Delayed weight bearing|Weight bearing performed 2 months after surgery
16278985|NCT00799344|Device|Catania Stent|coronary stent implantation
16278986|NCT00799331|Drug|AZD5985|Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.
16278987|NCT00799331|Drug|placebo|Oral suspension.
16278988|NCT00799292|Drug|Vasopressin|20cc of dilute vasopressin (20units in 50cc normal saline). At beginning of the procedure 5cc injected were injected at 2,4,8 and 10 o'clock on the cervix
16279025|NCT00798954|Device|Sirolimus-eluting coronary stent (Cypher)|Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
16278989|NCT00799279|Behavioral|Smoking cessation training, support, and telephone follow-up|The CF group will receive the same smoking cessation training and practice support tools delivered to the PS group. In addition, patients in the FC group who are smokers and are willing to set a quit date within the next 30 days and who have set a quit date will be enrolled in an interactive voice response (IVR)-mediated telephone follow-up and counselling system. The IVR system will automatically contact patients via telephone 7 days before their TQD, and 5, 14, 30, and 60 days after their TQD to check the patients' smoking status, potential concerns, and their risk of relapse.
16278990|NCT00799279|Behavioral|smoking cessation intervention|Intervention practices will be provided with training in smoking cessation, and will be supported with integrating a waiting room screener for smoking and smoking consult form and patient quit plan into their practice routines.
16278991|NCT00799266|Drug|Zoledronic acid|intravenous infusion
16278992|NCT00799266|Drug|Placebo|intravenous infusion
16278993|NCT00799240|Drug|Arm A: Pemetrexed Cisplatin|Pemetrexed: 500mg/m2 IV on day 1 and Cisplatin: 75 mg/m2 IV on day 1 every 21 days x 6 cycles.
16278994|NCT00799240|Drug|Arm B Pemetrexed, Cisplatin and MK-0646|Pemetrexed 500 mg/m2 IV on Day 1 and Cisplatin 75 mg/m2 IV on Day 1 every 21 days for 6 cycles in combination with MK-0646 will be given IV, 10 mg/KG, Days 1, 8 and 15 weekly.
16278995|NCT00799227|Drug|Dexamethasone|700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
16278996|NCT00799214|Drug|Placebo|1 gram emollient cream to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
16278997|NCT00799214|Drug|Boric acid|Boric acid = 600 mg boric acid compounded in emollient cream (1 gram total) to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
16278998|NCT00799214|Drug|Metronidazole|Metronidazole = 10 % intravaginal cream (Sanofi-Aventis Canada Inc Product DIN 01926861) (for a total of 37.5 mg metronidazole) to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
16278999|NCT00799201|Drug|Naloxone and Docusate|Naloxone 6mg (15 mL) every 6 hours plus docusate sodium liquid 10 mL (100mg) every 12 hours
16279000|NCT00799188|Drug|Everolimus|50% reduction of calcineurin inhibitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l.
16279001|NCT00799175|Drug|ropivacaine, ketorolac and epinephrine|In Group A, 400 mg ropivicaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue. After 21 postoperative hours in Group A, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
16279002|NCT00799175|Drug|saline|In Group P (placebo) no injections were given intraoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
16279003|NCT00799162|Other|Psychophysical testing, questionnaires, and genetics|pre-operative psychophysical testing of endogenous pain modulation, pre-operative questionnaires, peri- and post-operative data collection, long term follow-up assessing chronic pain, SNP association analysis, and whole genome scanning association studies
16279004|NCT00799149|Drug|Gabapentin, Etoricoxib, Sugar pill|Control (Sugar pill) or gabapentin (1200 mg) or etoricoxib (120 mg) administered 30-90 min before the patient entered the operating room with a sip of water. Subsequent doses of the oral study drugs were administered on the mornings (08H00) of the first, second, and third postoperative days. .
16279005|NCT00799136|Drug|R-EPOCH and cART|This is a prospective, single-arm, multi-centre, phase II trial of immuno-chemotherapy (rituximab and EPOCH) with mandatory combination antiretroviral therapy for initial treatment of AIDS-related lymphoma.
16279006|NCT00799110|Drug|GM-CSF|Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
16279007|NCT00799110|Biological|Dendritic Cell/Tumor Fusion Vaccine|Given subcutaneously once every three weeks for a total of three vaccines
16279008|NCT00799110|Drug|imiquimod|Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
16279009|NCT00799084|Behavioral|Nurse|Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
16279010|NCT00799084|Behavioral|AVR|Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management
16279011|NCT00799071|Drug|posaconazole (PSZ)|Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.
16279012|NCT00799058|Drug|dapivirine 4789|dapivirine gel 4789, 0.05%, 2.5g applied once daily
16279013|NCT00799058|Drug|dapivirine gel 4759|dapivirine gel 4759, 0.05%, 2.5g applied once daily
16279014|NCT00799058|Drug|Drug placebo|HEC-based universal placebo gel, 2.5g applied once daily
16279015|NCT00799045|Drug|Clopidogrel|Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.
16279016|NCT00799032|Device|PCI|coronary stent implantation
16279017|NCT00799006|Drug|Placebo|Subjects will be given placebo or PF-04620110
16279018|NCT00799006|Drug|PF-04620110|A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.
16279019|NCT00798993|Other|Structured Exercise program|30 minutes on an exercise bicycle during every dialysis
16279020|NCT00798993|Drug|Cholecalciferol (25-Hydroxyvitamin D)|Cholecalciferol 2000U per day will be given for duration of study to all participants
16279021|NCT00798993|Other|Usual exercise|Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months
16279022|NCT00798980|Drug|Mirena (BAY86-5028)|Nulliparous Women
16279023|NCT00798967|Drug|teduglutide|0.05 mg/kg/day sc injection for 24 weeks
16279024|NCT00798967|Drug|placebo|Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks
16279026|NCT00798954|Device|Paclitaxel-eluting stent (TAXUS)|Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
16279027|NCT00798941|Behavioral|mouth care|mouth spray, mouth swab, moisturizer
16279028|NCT00798941|Behavioral|pain intervention|music and massage
16279029|NCT00798915|Drug|Placebo|Intravenous infusion of 1% human albumin in normal saline
16279030|NCT00798915|Drug|Glucose-dependent Insulinotropic Polypeptide (GIP)|Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
16279031|NCT00798915|Drug|Xenin-25|Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
16279032|NCT00798915|Drug|Glucose-dependent Insulinotropic Polypeptide plus Xenin-25|Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
16279033|NCT00798902|Device|Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules|150 micrograms/cc BVF
16279034|NCT00798902|Other|Iliac crest autograft|autograft
16279035|NCT00798889|Drug|Sunitinib|Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol
16279036|NCT00798876|Dietary Supplement|Fish Oil|Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.
16279037|NCT00798876|Dietary Supplement|Vitamin E supplement|Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.
16279038|NCT00798876|Dietary Supplement|Western Diet|Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.
16279039|NCT00798876|Dietary Supplement|Low-Fat Diet|Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.
16279040|NCT00798876|Other|Medical Examination|Subjects will have a routine medical exam.
16279041|NCT00798876|Other|Dietary Interview|Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.
16279042|NCT00798876|Other|Blood Draw|40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.
16279043|NCT00798876|Procedure|Radical Prostatectomy|Subjects will undergo a radical prostatectomy as part of their standard of care.
16279044|NCT00798863|Procedure|video assisted submandibular sialadenectomy|Step 1: A 15 to 20 mm skin incision is performed. The anterior part of the gland is then dissected off the mylohyoid muscle. The superficial part of the gland is dissected free. Now, the free superficial part of the gland is resected .Step 2: The scope is inserted into the wound to view the deeper part of the gland. The latter is dissected and removed after identifying the tendon of the digastric muscle, the hypoglossal nerve, the lingual nerve and the submandibular duct. The lingual nerve is released from its attachment to the gland. The submandibular duct is ligated using 3/0 vicryl. The deep part of the gland is extracted through the wound. Hemostasis is secured.
16279045|NCT00798850|Procedure|Percutaneous Transluminal Angioplasty (PTA)|PTA will be performed by a consultant interventional radiologist with no deviation from the standard protocol at Hull & East Yorshire Yospitals NHS Trust.
16279046|NCT00798850|Procedure|Supervised Exercise Programme (SEP)|"SEP: Conducted 3 times per week for 12 weeks.The session will be supervised by a physiotherapist and conducted in the cardiac gym.
~Each session begins with gentle warming up exercises followed by an exercise circuit of 6 stations(2 minutes each).
~Station 1-Step-ups(20-cm high step,alternating leg after 10 step-ups)
~Station 2-Exercise bicycles
~Station 3-Knee extensions with weights(2kg beanbag)
~Station 4-Heel raises
~Station 5-Knee bends(Alternating legs after 10 bends)
~Station 6-Rest station(2Kg Biceps curls) Gentle walk for 2minutes in between the stations to recover.For first 6weeks patients complete one full circuit, followed by on extra station/week, thus by 12weeks patients will complete 2 full circuits.Finally patients perform a series of gentle stretching and cooling down exercises.
~This exercise programme was designed to comply with suggested guidelines based on a meta-analysis assessing the effectiveness of SEP for claudicants."
16279047|NCT00798850|Procedure|Combined Treatment|PTA will be performed according to routine protocol followed by enrollment of patient in SEP. SEP will commence in the week following PTA.
16279048|NCT00798837|Radiation|Intraprostatic maximal simultaneous boost|"Each patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) using RapidArc for optimization and delivery.
~Doses of radiotherapy are as follows:
~The prescription dose will be 73.7 Gy in 28 fractions
~A simultaneous intraprostatic boost will be given to as much of the CTV as possible without contravening OAR dose constraints."
16279049|NCT00798824|Procedure|Indwelling nasogastric tube placement|The premature infant is fed with an indwelling nasogastric tube during feeding transition.
16279050|NCT00798824|Procedure|Intermittent orogastric tube placement|The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
16279051|NCT00798824|Device|Nasogastric tube|Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
16279052|NCT00798824|Device|Oral gastric tube|Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
16279053|NCT00798811|Procedure|high-dose chemotherapy and autologous stem cell rescue|Surgery -> enroll Pre-RT chemotherapy (2 cycles: A1, B1) PBSC collection during first cycle (A1) (2nd look surgery if necessary) RT (Reduced dose CSI) Post-RT chemotherapy (4 cycles: A2, B2, A3, B3) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM)
16279054|NCT00798811|Procedure|high-dose chemotherapy and autologous stem cell rescue|Surgery pre-HDCT chemotherapy (6 cycles: A1, B1, A2, B2, A3, B3) PBSC collection during first cycle of chemotherapy (A1) (2nd look surgery if necessary) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM) (RT if necessary) Observe
16279055|NCT00798811|Procedure|high-dose chemotherapy and autologous stem cell rescue|(Surgery if possible) Chemotherapy (4 cycles) PBSC collection during first cycle of chemotherapy during 4th cycle of chemotherapy (if BM involvement) (RT, if possible, after PBSC collection) (if less than PR prior to HDCT, off study) HDCT1 (CTE) HDCT2 (CM)
16279056|NCT00798798|Device|Externally Implantable Tissue Expansion Device|Will Apply Externally Implantable Tissue Expansion Device for 2 Days
16279094|NCT00798551|Behavioral|Risk counseling|cardiovascular risk counseling regarding elevated blood pressure
16279057|NCT00798785|Drug|ATG-MMF-TAC|"ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
~Tacrolimus levels for 2 years between 8-10 ng/ml.
~At year 2: randomization:
~group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant subcutaneous (total n=5) at the time of the first clinical implant in the liver."
16279058|NCT00798785|Drug|ATG-Rituximab-MMF-TAC|"ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
~Rituximab: the day before transplantation, day 5; 12 and 19 after implantation. Tacrolimus levels for 2 years between 8-10 ng/ml.
~At year 2: randomization:
~group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver."
16279059|NCT00798785|Drug|ATG-basilixumab-MMF-TAC|"First transplantation:
~ATG-fresenium for max 6 consecutive days depending on CD3 count, starting the day before transplantation.
~Second transplantation:
~Basilixumab:
~the day before the second transplantation followed by 4days after transplantation.
~Tacrolimus levels for 2 years between 8-10 ng/ml.
~At year 2: randomization:
~group A: till 48 months: tacrolimus levels 8-10 ng/ml 48-60 months: tacrolimus levels 6-8 ng/ml group B: 24-36 months: 6-8 ng/ml 36-60 months: 4-6 ng/ml A subgroup of these patients will receive a sub clinical implant, subcutaneous at the time of the first clinical implant in the liver."
16279060|NCT00798785|Procedure|omentum|"Two clinical implants: first in omentum followed by a clinical implant in the liver:
~In a group of 10 patients, a clinical implant in the omentum will be implanted. If random C-peptide levels >= 0.5 ng/ml are measured at 2 months post-transplantation, a second omental implant will be done. If no clinical relevant beta cell graft function is measured, two intraportal implants will be given as a compassionate use procedure. An interim analysis after 5 patients has to shown clinical relevant function at month 2 in 3 out of 5 patients before the subsequent 5 patients can be transplanted in the omentum."
16279061|NCT00798772|Dietary Supplement|Micronutrients and antioxidants|8 capsules twice daily for two years
16279062|NCT00798772|Dietary Supplement|Multivitamins and minerals|8 capsules twice daily for two years
16279063|NCT00798759|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
16279064|NCT00798759|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
16279065|NCT00798746|Behavioral|Telephone Questionnaire|Ten questions regarding symptoms of reflux
16279066|NCT00798720|Drug|vorinostat|400 mg by mouth once daily for days 1-14 of each 21 day cycle
16279067|NCT00798720|Drug|bortezomib|1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle
16279068|NCT00798707|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|25 mg tablet, once daily dosing for 8 weeks
16279069|NCT00798707|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|50 mg tablet, once daily dosing for 8 weeks
16279070|NCT00798707|Drug|placebo|Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
16279071|NCT00798694|Drug|Xalatan|one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
16279072|NCT00798694|Drug|Travatan Z|one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
16279073|NCT00798681|Dietary Supplement|RTU TPN with olive oil as the primary lipid source|RTU will be provided as a 3 in 1 TPN ready-to-use TPN system in industrialized bags with 2.000 ml. The number of calories will be adjusted in accordance with patients' individual needs.
16279074|NCT00798681|Other|CNF Parenteral nutrition|CNF parenteral nutrition made with olive oil as the primary source of lipids
16279075|NCT00798681|Other|CNF parenteral nutrition|3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids
16279076|NCT00798668|Dietary Supplement|Liquid Supplements|Liquid supplement that provides 12.5% of the subjects total energy requirement.
16279077|NCT00798668|Dietary Supplement|Solid Supplement|Solid supplement that provides 12.5% of the subjects total energy requirement.
16279078|NCT00798655|Drug|Panitumumab|"Panitumumab, starting dose, 2.5mg/kg will be given as an intravenous infusion (IV) through a vein in your arm, once a week before radiation and chemotherapy for 6 weeks; treatment takes about an hour.
~The panitumumab dose will be calculated based on the subject's actual weekly body weight"
16279079|NCT00798655|Drug|Cisplatin|Cisplatin, 30 mg/m2 will be given as an intravenous infusion (IV) through a vein in your arm, once a week before radiation therapy and after panitumumab for 6 weeks; treatment takes about an hour
16279080|NCT00798655|Radiation|Radiation Therapy|"Radiation Therapy 60-66 Gy/200 cGy/daily, five days a week, Monday through Friday, except on weekends and holidays, for six weeks; treatments take about 20 minutes.
~Radiation will be administered either prior to chemo treatment or after chemo treatment as long as radiation is given on the same day."
16279081|NCT00798642|Behavioral|Hypnotherapy|8 weeks of gut-directed hypnotherapy
16279082|NCT00798642|Behavioral|Standard care|8 weeks of standard of care
16279083|NCT00798642|Behavioral|Mind Body Therapy|8 weeks of mind-body therapy
16279084|NCT00798629|Biological|Autologous dendritic cell-adenovirus CCL21 vaccine|Intradermal injections of adenovirus-CCL-21 transduced class I peptide-pulsed DC
16279085|NCT00798616|Drug|prednisolone or methylprednisolone|either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
16279086|NCT00798616|Drug|placebo|oral or IV placebo
16279087|NCT00798603|Biological|bevacizumab|
16279088|NCT00798603|Drug|carboplatin|
16279089|NCT00798603|Drug|pemetrexed disodium|
16279090|NCT00798590|Drug|Glucagon-Like Peptide-1|5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
16279091|NCT00798590|Drug|Saline|5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
16279092|NCT00798577|Drug|Vigamox Ophthalmic Solution|Moxifloxacin 5mg/mL 3 times daily for 7 days
16279093|NCT00798577|Drug|BSS placebo|Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
16279095|NCT00798538|Other|Services will be provided at one site|Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..
16279096|NCT00798538|Other|Services remain dispersed; i.e., not centralized to one-location or provider.|Buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively.
16279097|NCT00798525|Drug|Argatroban|Argatra (Argatroban) will be diluted to 0.6 mg/ml and 0.5 µg/kg/min will be administered continuously in patients without liver disfunction. In patients with liver disfunction, defined by a bilirubin of > 4mg/dl, argatroban will be administered as a continuous infusion of 0,25 µg/kg/min with a final concentration of 0,3 mg/ml.
16279098|NCT00798525|Drug|Lepirudin|Refludan (Lepirudin) will be diluted to a final concentration of 0.1mg/ml and initiated as a continuous infusion of 5µg/kg/h in patients with continuous renal replacement therapy. In patients with moderate renal impairment (Creatinine ≥1,3 mg/dl) a final concentration 0,2 mg/ml of will be used to provide continuous infusion of 10 µg/kg/h. Patients without renal impairment (Creatinine < 1,3 mg/dl) will receive a continuous infusion of 50 µg/kg/h by a final concentration of 1 mg/ml of Lepirudin.
16279099|NCT00798512|Device|Carotid artery stenting|"The MO.MA is a cerebral protection catheter based on the proximal flow blockage concept which is achieved by endovascular clamping of Common Carotid Artery (CCA) and External Carotid Artery (ECA). The MO.MA proximal flow blockage cerebral protection device is indicated to be used in patients eligible for carotid angioplasty and/or the carotid bifurcation and is aimed to prevent brain embolism during the stenting procedure.
~For the purpose of this study the Cristallo Ideale™ Carotid Stent System (Invatec S.R.L. Roncadelle, Italy) will be exclusively used. Cristallo Ideale™ consists of a carotid dedicated self-expanding stent pre-mounted on a rapid exchange delivery catheter. The stent platform is made of a Nitinol alloy and characterized by a hybrid design with closed cell in the central zone and open cell in both end zones (proximal and distal)."
16279100|NCT00798499|Other|Laboratory variables|1 visit
16279101|NCT00798486|Device|A1C Test Kit|Subjects tested 3 times with A1C test kits. Two tests were performed by the subject and the third test was performed by a healthcare professional (HCP). All results were compared to results from a laboratory glucose analyzer (TOSOH).
16279102|NCT00798473|Drug|zoledronic acid|Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
16279103|NCT00798473|Other|IV saline infusion|
16279104|NCT00798460|Drug|adefovir|adefovir 10mg
16279105|NCT00798460|Drug|clevudine|clevudine 30mg
16279106|NCT00798460|Drug|lamivudine|lamivudine 100mg
16279107|NCT00798447|Drug|MLF 541|22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
16279108|NCT00798447|Drug|Lipofundin MCT|22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
16279109|NCT00798434|Drug|Placebo|placebo administered orally in the morning or evening.
16279110|NCT00798434|Drug|Fesoterodine fumarate|Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
16279111|NCT00798408|Dietary Supplement|Fluid Supplement|The fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients
16279112|NCT00798408|Dietary Supplement|Solid Supplement|The solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation*1.5 activity factor, volume, and amount and type of macronutrients
16279113|NCT00798395|Drug|Org 50081|1.5 mg on day 1-7
16279114|NCT00798395|Drug|Org 50081|4.5 mg on Day 1-7
16279115|NCT00798395|Drug|Placebo|Once daily on Day 1-7
16279116|NCT00798395|Drug|zopiclone|Single dose of 7.5 mg
16279117|NCT00798382|Other|soy protein formula|ad lib for 0-35 days of age
16279118|NCT00798382|Other|Commercially available soy formula|ad lib for 0-35 days of age
16279119|NCT00798382|Other|Soy formula experimental #2|ad lib for 0-35 days of age
16279120|NCT00798369|Drug|Canakinumab|Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
16279121|NCT00798369|Drug|Canakinumab|Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.
16279122|NCT00798369|Drug|Canakinumab|Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.
16279123|NCT00798369|Drug|Canakinumab|Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.
16279124|NCT00798369|Drug|Canakinumab|Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.
16279125|NCT00798369|Drug|Triamcinolone acetonide|Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
16279126|NCT00798356|Other|Yoga training|Yoga training for 12 weeks
16279127|NCT00798343|Biological|Seasonal vaccine|Non-adjuvanted seasonal influenza vaccine (total dose 45ug)
16279128|NCT00798343|Biological|H5 vaccine|MF59-adjuvanted A/Vietnam/1194 H5N1 vaccine 7.5ug dose
16279129|NCT00798317|Drug|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection
16279130|NCT00798317|Drug|Placebo|Intravitreal injection placebo.
16279131|NCT00798304|Biological|meningococcal B rLP2086 vaccine|vaccination
16279132|NCT00798304|Biological|Routine age appropriate childhood vaccines|vaccination
16279133|NCT00798304|Biological|meningococcal B rLP2086 vaccine|vaccination
16279134|NCT00798304|Biological|Routine age appropriate childhood vaccines|vaccination
16279135|NCT00798304|Biological|Routine age appropriate childhood vaccines|vaccination
16279136|NCT00798291|Other|Ad lib diet and Control placebo|one packet with water two times a day
16279137|NCT00798291|Other|Ad lib diet and An 777|one packet with water two times a day
16279138|NCT00798291|Other|Ad lib diet/ placebo/ exercise|one packet with water two times a day; resistance training three times a week
16279139|NCT00798291|Other|Ad lib diet; AN 777; exercise|one packet with water two times a day; resistance training three times a week
16279140|NCT00798278|Drug|Urokinase|Chest tube with intrapleural urokinase infusion for 3 days
16279141|NCT00798278|Procedure|Video-Assisted Thoracoscopic|Video-Assisted Thoracoscopic decortication
16279144|NCT00798252|Drug|Capecitabine|Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression
16279145|NCT00798252|Drug|Doxorubicin|IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression
16279146|NCT00798252|Drug|Ixabepilone|IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression
16279147|NCT00798252|Drug|Docetaxel|IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression
16279148|NCT00798252|Drug|Paclitaxel|IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression
16279149|NCT00798252|Drug|Brivanib alaninate|Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
16279150|NCT00798239|Device|Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules|150 micorgrams/cc BVF
16279151|NCT00798239|Other|Iliac crest autograft|autograft
16279152|NCT00798239|Device|Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules|750 micrograms/cc BVF
16279153|NCT00798226|Dietary Supplement|n-3 fatty acid|Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery
16279154|NCT00798226|Dietary Supplement|olive oil|Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery
16279155|NCT00798213|Drug|SCH 727965|SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
16279156|NCT00798213|Drug|Gemtuzumab ozogamicin|Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
16279157|NCT00798200|Other|Exercise program|All exercise programs will include endurance and strength exercises.
16279158|NCT00798187|Behavioral|Group Meetings|10 weekly group meetings lasting 2 hours.
16279159|NCT00798187|Behavioral|Questionnaire|Surveys
16279160|NCT00798174|Device|Standard configuration vs. azygos coil|Addition of an azygos vein defibrillation coil instead of a standard SVC coil.
16279161|NCT00798161|Drug|BI 1356|BI 1356 high dose tablet, once daily
16279162|NCT00798161|Drug|BI 1356 + metformin|BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily
16279163|NCT00798161|Drug|Bi 1356 + metformin|BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily
16279164|NCT00798161|Drug|Metformin|Metformin 500 mg tablet, twice daily
16279165|NCT00798161|Drug|metformin|metformin 1000 mg tablet, twice daily
16279166|NCT00798161|Drug|matching placebo|matching placebo
16279167|NCT00798148|Drug|131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation|131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation
16279168|NCT00798135|Drug|itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
16279169|NCT00798122|Procedure|Intravascular ultrasound|intravascular ultrasound
16279170|NCT00798122|Procedure|MRI|cardiac MRI
16279171|NCT00798109|Behavioral|Motivational therapy|One hour of motivational therapy each weak during 4 weeks
16279172|NCT00798109|Behavioral|Usual care|Patients received at least six hour of usual therapy, as in the experimental group
16279173|NCT00798096|Drug|Fostamatinib Disodium|200 mg PO BID
16279174|NCT00798083|Drug|topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)|Subjects will be taught to apply topical 2%amitriptyline, 1% ketamine and 5% lidocaine(AKL) in PLO gel to the sites of maximum neuropathic pain three times per day for up to 2 weeks after completion of radiotherapy.
16279175|NCT00798070|Drug|dtEC→dtT|Individually tailored and two weekly dosed epirubicin (start dose 90mg/m2) + cyclophosphamide (start dose 600mg/m2) followed by a three weeks break followed by biweekly and tailored docetaxel (start dose 75mg/m2) given every second week. If toxicity measured by CTC-NCI criteria are grade 2 or less (except haematological toxicity) it will be possible to escalate doses
16279176|NCT00798070|Drug|FEC→T|Fixed dosed and three weekly epirubicin (100mg/m2), cyclophosphamide (500mg/m2) and 5-fluorouracil (500mg/m2), followed by fixed dosed and three weekly docetaxel (100mg/m2), no dose escalations.
16279177|NCT00798044|Behavioral|Other: quality improvement feedback system|Surveys patients regarding treatment experiences.
16279178|NCT00798044|Behavioral|Patient Feedback|Weekly feedback reports provided to counselors
16279179|NCT00798031|Device|A minimum of two but up to three Astra Tech Dental Implant, Fixture Osseospeed will be placed in the posterior upper jaw of 20 eligible subjects.|A minimum of 2 but up to three dental implants will be placed in the posterior upper jaw of 20 subjects. The dental implants are produced by Astra Tech AB (Fixture Micro Thread OsseoSpeed TM Astra Tech AB. The study will include 15 clinic visits and interim analysis will occur at 6 months, 1, 2, and 3 years after loading of the temporary prosthesis.
16279180|NCT00798031|Device|Placement of dental implant|"Device: A minimum of two but up to three Astra Tech Dental Implant, Fixture Osseospeed will be placed in the posterior upper jaw of 20 eligible subjects.
~A minimum of 2 but up to three dental implants will be placed in the posterior upper jaw of 20 subjects. The dental implants are produced by Astra Tech AB (Fixture Micro Thread OsseoSpeed TM Astra Tech AB. the study will include 15 clinic visits and interim analysis will occur at 6 months, 1, 2, and 3 years after loading of the temporary prothesis."
16279181|NCT00798031|Device|dental implant|Subjects will have a complete diagnostic work-up performed and assessment for eligibility in the study by both a Prosthodontist and Surgeon. Subjects will then have two and up to three dental implants placed in an out patient basis at the University of Iowa College of Dentistry
16279182|NCT00798018|Drug|2% lidocaine|lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
16279323|NCT00796887|Drug|Placebo|Placebo tablet once daily
16279183|NCT00798018|Drug|placebo|Air injected into the cuff to seal the space between the trachea and the tube at minimal volume
16279184|NCT00798018|Drug|1% tetracaine|tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
16279185|NCT00798018|Drug|N.S|0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume
16279186|NCT00798005|Drug|XRP0038 (NV1FGF)|
16279187|NCT00797992|Drug|Injection|Intravitreal injection of 1.25 mg bevacizumab
16279188|NCT00797979|Device|Skull Grip bone fixation|Skull Grip bone fixation
16279189|NCT00797979|Device|sutures|Standard skull bon flap fixation, sutures
16279190|NCT00797966|Drug|OPC-34712|Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
16279191|NCT00797966|Drug|Placebo|Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
16279192|NCT00797966|Drug|ADT|Tablets, 10 - 225 mgs, dose once daily, 14 weeks
16279193|NCT00797953|Drug|T89|A two-herb botanical drug product in 62.5mg capsule formulation. It is to be used as 125mg or 187.5mg twice daily.
16279194|NCT00797940|Drug|IL-4PE|Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
16279195|NCT00797927|Drug|quetiapine|quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
16279196|NCT00797927|Other|no intervention|keep the original conventional antipsychotic agent for 28 days
16279197|NCT00797901|Other|Collaborative Care|
16279198|NCT00797888|Behavioral|telephonic|Between 4-8 phone calls each year for health behavior counseling to improve HbA1c
16279199|NCT00797875|Procedure|PNF stretching|PNF stretching x 5 repetitions and continue 3 days
16279200|NCT00797875|Procedure|passive stretching|passive stretching x 5 repetitions continue 3 days
16279201|NCT00797862|Drug|Amlodipine|Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
16279202|NCT00797862|Drug|hydrochlorothiazide|Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
16279203|NCT00797862|Drug|Aliskiren|Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
16279204|NCT00797849|Device|Farabloc Limb Cover|Wear prosthetics, sock or glove laminated with Farabloc
16279205|NCT00797849|Device|Sham Limb Cover|Wear prosthetics, sock or glove laminated with sham material
16279206|NCT00797836|Procedure|Quantiferon Gold|"Interferon-gama release assay evaluating tuberculosis-specific T-lymphocytic response
~Health Personnel Hospitals, General Occupational Diseases/*epidemiology/*statistics & numerical data Occupational Exposure/*statistics & numerical data
~Tuberculosis/*diagnosis/*epidemiology/prevention & control Immunologic Tests/methods/*standards Disease Transmission, Horizontal/*statistics & numerical data Patient Isolation
~Tuberculin Test/standards/*methods Immunoassay/methods/*standards T-Lymphocytes/immunology Interferon Type II/*blood/*analysis
~*Reagent Kits, Diagnostic
~Mass Screening/*methods Incidence Follow-Up Studies Comparative Study Sensitivity and Specificity Risk Assessment/*methods"
16279207|NCT00797823|Drug|Insulin, Asp(B28)-|Insulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm
16279208|NCT00797823|Drug|Glucagon|During incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm
16279209|NCT00797823|Drug|Placebo|Saline solution 0.9%
16279210|NCT00797810|Drug|Rituximab|
16279211|NCT00797797|Drug|No Treatment Added|No added treatment
16279212|NCT00797797|Drug|Milnacipran Added|Milnacipran 100 mg/d added
16279213|NCT00797784|Drug|etanercept(Enbrel®)|etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks
16279214|NCT00797771|Device|"Adi Insulin pump"|insulin delivery will be defined by the physician
16279215|NCT00797758|Other|Cord blood transplantation|Umbilical cord blood transplantation after reduced intensity conditioning
16279216|NCT00797745|Biological|peginterferon alfa 2b|1.5 mcg/kg subcutaneously weekly for up to 24 or 48 weeks
16279217|NCT00797745|Drug|ribavirin|ribavirin 600 to 1400 mg daily (weight-based dosing) by mouth twice daily for up to 24 or 48 weeks
16279218|NCT00797745|Drug|SCH 900518|SCH 900518 100 mg tablets taken as 200 mg PO QD, 100 mg PO BID, 400 mg PO QD, or 600 mg PO QD for 12 weeks.
16279219|NCT00797745|Drug|ritonavir|Ritonavir 100 mg capsules taken as 100 mg PO QD or 100 mg PO BID for 12 weeks.
16279220|NCT00797732|Device|Acupuncture|
16279221|NCT00797719|Other|Pre-op RT +/- chemotherapy|Patients on the study will receive IMRT for approximately 1 week of 5 daily treatments. Short pre-operative hemithoracic RT is a new technique. 1 week post-RT, they will proceed with an extrapleural pneumonectomy. If the mediastinal lymph nodes that are removed during surgery are positive for tumour cells, 3 cycles of chemotherapy, consisting of raltitrexed and cisplatin, will be given 6-12 weeks post-surgery.
16279222|NCT00797706|Drug|CHRONSEAL|Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
16279223|NCT00797693|Drug|Misoprostol ( Cytotec) 200 microgram a tablet|In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.
16279224|NCT00797680|Other|72 hours hypothermia|72 hours mild hypothermia (33 +/1 1 degree Celsius)
16279225|NCT00797680|Other|24 hours hypothermia|24 hours mild hypothermia (33 +/1 1 degree Celsius)
16279226|NCT00797667|Drug|Telcagepant 140 mg|
16279227|NCT00797667|Drug|Telcagepant 280 mg|
16279228|NCT00797667|Drug|140 mg telcagepant placebo|
16279229|NCT00797667|Drug|280 mg telcagepant placebo|
16279230|NCT00797654|Behavioral|Information-motivation-behavior skills and cognitive processing therapy|Treatment will include elements from effective interventions for reducing risky sexual behaviors and reducing post-traumatic stress disorder (PTSD) symptoms.
16279231|NCT00797654|Behavioral|Pre and Post HIV-Test Counseling|Treatments are aimed at assessing and reducing behaviors that put participants at high risk of HIV infection.
16279232|NCT00797628|Behavioral|Decide2Quit|Patient intervention website that includes 1) interactive calculators to assess readiness to quit, symptoms and quit plan, 2) motivational content, and 3) links to other high quality information.
16279324|NCT00796874|Other|active surveillance|Correlative Study
16279233|NCT00797628|Behavioral|Smoking Coach|"Control Patients will be referred by paper prescription to the control- Smoking Coach website."
16279234|NCT00797615|Behavioral|Active intervention|12-week family-based weight gain intervention program focused on dietary intake and physical activity for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
16279235|NCT00797615|Behavioral|Alternative Intervention|12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
16279236|NCT00797589|Drug|HES|20ml/kg as prime fluid
16279237|NCT00797589|Drug|Ringer lactate|
16279238|NCT00797563|Device|Apollo Blood Glucose Monitoring System|Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
16279239|NCT00797550|Biological|Bone Repair Cells (BRCs)|BRCs will be administered during spine fusion surgery
16279240|NCT00797550|Procedure|Autologous bone graft|
16279241|NCT00797537|Procedure|Echography|Echography
16279242|NCT00797511|Biological|TdcP-IPV vaccine|0.5 mL, Intramuscular
16279243|NCT00797498|Other|Xerostomia questionnaire|All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire.
16279244|NCT00797485|Biological|bevacizumab|Given IV
16279245|NCT00797485|Drug|capecitabine|Given orally
16279246|NCT00797485|Drug|fluorouracil|Given IV
16279247|NCT00797485|Drug|irinotecan hydrochloride|Given IV
16279248|NCT00797485|Drug|leucovorin calcium|Given IV
16279249|NCT00797472|Drug|R-mabHD|An intravenous infusion containing R-mabHD 375mg/m2 will be administered over a period of 3 to 8 hours every week for eight weeks in a row.
16279250|NCT00797472|Drug|ABVD|A combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) will be given intravenously over a period of 3 hours every other week for 12 treatments.
16279251|NCT00797459|Device|Restylane and Restylane-L|This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
16279252|NCT00797420|Drug|Fluconazole Loading Dose|Single Fluconazole loading dose 25 mg/kg
16279253|NCT00797420|Drug|Fluconazole Loading Dose & High Dose|Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days
16279254|NCT00797407|Dietary Supplement|Creatine|Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day
16279255|NCT00797394|Dietary Supplement|Combination of 2007RD01 and saw palmetto lipidic extract|Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
16279256|NCT00797394|Dietary Supplement|Saw palmetto lipidic extract|Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
16279257|NCT00797368|Other|Manual Therapy and Exercise|Manual Therapy and Exercise
16279258|NCT00797368|Other|Home exercises|Home exercises
16279259|NCT00797342|Drug|PF-04629991|Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
16279260|NCT00797342|Drug|PF-04629991|Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
16279261|NCT00797342|Drug|PF-04629991|Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)
16279262|NCT00797329|Other|chart review|"cholesterol
~cognitive profiles
~violent behavior"
16279263|NCT00797316|Drug|Aliskiren|Aliskiren 150 mg or 300 mg taken once daily in oral form
16279264|NCT00797316|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.
16279265|NCT00797303|Drug|Bevacizumab|subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months
16279266|NCT00797277|Drug|IM olanzapine|10mg olanzapine IM
16279267|NCT00797277|Drug|IM haloperidol plus lorazepam|IM 5 mg haloperidol plus IM 2 mg lorazepam
16279268|NCT00797264|Drug|Ketamine-Morphine|Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
16279269|NCT00797264|Drug|Morphine|Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
16279270|NCT00797264|Drug|Postoperative PCA of Ketamine and morphine|Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)
16279271|NCT00797251|Procedure|Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.|The technique consists in IOUS-guided finger compression of the right posterior portal pedicle at the level closest to the tumor but oncologically suitable. This method allows us to anatomically mark the area of resection with nor hilar plate nor IOUS-guided puncture of vessels, which are up to date the only two techniques available to perform anatomical right posterior sectionectomy - namely the removal of segment 6 and 7.
16279272|NCT00797225|Drug|Leuprorelin Acetate Depot|Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection
16279273|NCT00797225|Drug|Elagolix|Elagolix tablets administered orally
16279274|NCT00797225|Drug|Placebo to Elagolix|Placebo tablet administered orally
16279275|NCT00797225|Drug|Placebo to Leuprorelin Acetate|Saline solution administered as an intramuscular injection
16279276|NCT00797212|Device|Apollo Blood Glucose Monitoring System|Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
16279277|NCT00797186|Other|Intensive risk factor management|Aggressive medical and lifestyle therapy.
16279278|NCT00797160|Drug|propofol|2mg/Kg IV in bolus before tracheal intubation
16279279|NCT00797121|Procedure|Preoperative biliary drainage|Percutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L.
16279325|NCT00796874|Other|imaging biomarker analysis|Correlative Study
16279280|NCT00797108|Drug|sulopenem and PF-03709270|Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day
16279281|NCT00797108|Drug|Sulopenem and PF-03709270|Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day
16279282|NCT00797108|Drug|Ceftriaxone and amoxicillin/clavulanate|IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)
16279283|NCT00797082|Device|MRI|MRI = Myocardial Perfusion Stress
16279284|NCT00797082|Device|MPS|MPS = Myocardial Perfusion Scintigraphy
16279285|NCT00797069|Other|standard nutritional product (medical food)|once during crossover
16279286|NCT00797069|Other|nutritional product for diabetes (medical food)|once during crossover
16279287|NCT00797069|Other|diabetes specific experimental nutritional product (medical food)|once during crossover
16279288|NCT00797056|Drug|G-CSF|G-CSF 5 mcg/kg/day SQ daily for 10 days
16279289|NCT00797056|Drug|Placebo|Saline SQ daily for 10 days
16279290|NCT00797056|Drug|Aspirin|Aspirin 75 mg/day for 14 days
16279291|NCT00797056|Drug|Clopidogrel|Clopidogrel 75mg/day daily for 14 days
16279292|NCT00797030|Drug|cyclosporine and sodium carboximethycellulose|Ten HIV-positive patients with dry eye received sodium carboximethylcellulose 0.5% (one drop 4 times per day) and topical cyclosporine 0.05% (one drop twice a day) during six months
16279293|NCT00797030|Drug|sodium carboximethycellulose|Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months
16279294|NCT00797017|Drug|fentanyl|Infection, starting with 12mcg/h (flexible dose)
16279295|NCT00797017|Drug|fentanyl|(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)
16279296|NCT00797017|Drug|fentanyl|Bone Fracture, starting with 12mcg/h (flexible dose)
16279297|NCT00797017|Drug|fentanyl|(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)
16279298|NCT00797017|Drug|fentanyl|Other Deformity, starting with 12mcg/h (flexible dose)
16279299|NCT00797017|Drug|fentanyl|(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)
16279300|NCT00797017|Drug|fentanyl|Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
16279301|NCT00796991|Drug|Ipilimumab|Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
16279302|NCT00796991|Drug|Carboplatin|Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
16279303|NCT00796991|Drug|Paclitaxel|Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
16279304|NCT00796991|Drug|Dacarbazine|Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
16279305|NCT00796978|Biological|trastuzumab|Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
16279306|NCT00796978|Other|laboratory biomarker analysis|Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).
16279307|NCT00796978|Procedure|adjuvant therapy|Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
16279308|NCT00796978|Procedure|quality-of-life assessment|Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.
16279309|NCT00796965|Drug|AZD7268|Solution/Capsule, Oral, once daily
16279310|NCT00796965|Drug|Placebo|
16279311|NCT00796952|Behavioral|focused attention sessions|"Patient management by the attending Radiation oncologist as usual. Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period."
16279312|NCT00796952|Behavioral|Valchuff|"Standardised sham or placebo swallowing therapy comprised a buccal extension maneuver (valchuff) and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment."
16279313|NCT00796952|Behavioral|Pharyngocise|Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks)
16279314|NCT00796939|Device|Green light mask|Participants will receive approximately 10,000 lux from green light-emitting diodes.
16279315|NCT00796939|Device|Red Light Mask|Participants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel.
16279316|NCT00796926|Drug|Systane Ultra eyedrops|Four times a day
16279317|NCT00796926|Drug|Refresh eye drops|Four times a day
16279318|NCT00796913|Other|Stop medication|Stop medication Stop medication + se supplement
16279319|NCT00796900|Drug|Dantrolene|Patients who satisfy the inclusion/exclusion criteria of the study and who are enrolled in this study will be randomized with computer-generated grouping to either one of two groups. One group of subjects will be given dantrolene for the first episode of fever. The other group will be given placebo. Dantrolene is supplied in 70-ml vials containing 20 mg dantrolene. Dantrolene will be given in the following dose: 5 mg/kg BW given intravenously over 30 minutes. As placebo NaCl 0,9% will be used.
16279320|NCT00796900|Drug|Placebo|Patients who satisfy the inclusion/exclusion criteria of the study and who are enrolled in this study will be randomized with computer-generated grouping to either one of two groups. One group of subjects will be given dantrolene for the first episode of fever. The other group will be given placebo. Dantrolene is supplied in 70-ml vials containing 20 mg dantrolene. Dantrolene will be given in the following dose: 5 mg/kg BW given intravenously over 30 minutes. As placebo NaCl 0,9% will be used.
16279321|NCT00796887|Drug|Extended-Release Niacin|500mg tablet once daily
16279322|NCT00796887|Drug|Extended-Release Niacin|1000mg tablet once daily
16279326|NCT00796874|Procedure|biopsy|Tissue Removal
16279327|NCT00796874|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Radiolical Medical Imaging
16279328|NCT00796874|Procedure|magnetic resonance imaging|Radiolical Medical Imaging
16279329|NCT00796874|Procedure|magnetic resonance spectroscopic imaging|Radiolical Medical Imaging
16279330|NCT00796861|Drug|Sunitinib|Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
16279331|NCT00796848|Device|Navigator Continuous Glucose Monitor|
16279332|NCT00796835|Drug|ER OROS Paliperidone|
16279333|NCT00796822|Drug|Pentoxifylline|400 mg three times a day for 8 weeks
16279334|NCT00796822|Drug|Placebo|One pill three times a day for 8 weeks
16279335|NCT00796796|Drug|Temsirolimus|
16279336|NCT00796796|Radiation|Radiation therapy|
16279337|NCT00796783|Drug|Cushing's syndrome confirmation|
16279338|NCT00796770|Biological|Dendritic Cell Vaccine|"Biological/Vaccine: Experimental: Dendritic Cell Vaccine Patients will receive 4 doses of the vaccine at weeks 0, 4, 8 and 12. The vaccine will be injected subcutaneously, in 3 separate injection sites in the upper and lower extremities.
~At week 24, patients will have HAART treatment interrupted. The HAART treatment will be resumed at week 48 or earlier at any time point if one of the following occur:
~two consecutive measurements of CD4+ T cell count below 350x10e6 cells/L and/or 25% of total lymphocytes within at least a 2 weeks
~an opportunistic infection
~a CDC class C-defining event (defined in appendix 2)
~a serious non-AIDS defining event.
~Patients will have follow-up visits on weeks: 22, 24, 25, 26, 27, 28, 32, 36, 40, 44, and 48."
16279339|NCT00796757|Drug|bevacizumab [Avastin]|10mg/kg iv infusion every 2 weeks
16279340|NCT00796757|Drug|interferon alfa-2a|3 MIU sc t.i.w.
16279341|NCT00796744|Drug|NorLeu3-A(1-7) in a gel formulation|Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
16279342|NCT00796731|Drug|SAR3419|administered by intravenous infusion
16279343|NCT00796718|Radiation|Standard radiotherapy|Administered as prescribed according to normal clinical practice.
16279344|NCT00796718|Drug|Capecitabine [Xeloda]|825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.
16279345|NCT00796705|Drug|Adalimumab|40 mg injection of adalimumab administered subcutaneously
16279346|NCT00796705|Drug|Adalimumab placebo|1.0 ml .9% saline placebo administered subcutaneously
16279347|NCT00796705|Drug|Etanercept|50 mg dimeric fusion protein administered subcutaneously
16279348|NCT00796692|Drug|Nadroparin|LMWH is given with a weight adjusted dose of 86 international anti-factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight(86 anti-factor Xa IU/kg) subcutaneously every 12 hours,which will be used at least 5-7 days.
16279349|NCT00796692|Drug|Unfractionated heparin(UFH)|UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub-therapeutic APTT had been measured after a dose adjustment, and otherwise daily.UFH will be used at least 5-7 days.
16279350|NCT00796679|Drug|paricalcitol|oral paricalcitol capsule 1 microgram once daily if iPTH <500pg/mL or 2 microgram once daily if iPTH >=500pg/mL. Thereafter, dose titration in 1 microgram decrement will be done based on safety reasons (that is, for low PTH or high calcium and phosphorus level). The duration of treatment will be for 1 year.
16279351|NCT00796666|Drug|Sitaxsentan|Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
16279352|NCT00796666|Drug|Sitaxsentan and Sildenafil|Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
16279353|NCT00796653|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16279354|NCT00796653|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16279355|NCT00796653|Drug|Formoterol|Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
16279356|NCT00796653|Drug|Placebo|Placebo devices for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
16279357|NCT00796640|Drug|ER Paliperidone|
16279358|NCT00796627|Genetic|Healthy volunteers|Comparison of healthy volunteers to burn wounded volunteers
16279359|NCT00796627|Other|Burn volunteers|Comparison of burn wounded volunteers to healthy volunteers
16279360|NCT00796614|Drug|tamsulosin hydrochloride|Oral
16279361|NCT00796614|Drug|Placebo|Oral
16279362|NCT00796601|Drug|Esreboxetine|Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
16279363|NCT00796601|Drug|Placebo|Film coated tablets (0 mg esreboxetine), once daily for 6 months
16279364|NCT00796588|Other|remote preconditioning|Three periods of 10 minute occlusion of blood supply to leg using a pneumatic tourniquet
16279365|NCT00796575|Drug|CS-8080|CS-8080 1mg tablets, 3 tablets administered 1 times per day
16279366|NCT00796575|Drug|placebo tablets|placebo tablets matching active
16279367|NCT00796575|Drug|CS-8080|CS-8080 5 mg tablets, 2 tablets administered 1 times per day
16279368|NCT00796575|Drug|CS-8080|CS-8080 5 mg tablets, 4 tablets administered 1 times per day
16279369|NCT00796562|Drug|Busulfan|Participant will receive Busulfan injections, 4 times a day for 4 days with dilantin prophylaxis (in patients 10 years of age or older). Busulfan levels in the blood will be measured and dose adjusted, if needed.
16279370|NCT00796562|Drug|Cyclophosphamide|Patient will receive Cy by IV once a day for 2 days.
16279371|NCT00796562|Radiation|Total body irradiation|Patients will receive TBI once a day for 4 days.
16279372|NCT00796549|Drug|BiBW 2992|BIBW 2992 in EGFR FISH positive NSCLC patients
16279373|NCT00796536|Behavioral|Group cognitive behavioral therapy|Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
16279485|NCT00795730|Drug|NSA-789|
16279486|NCT00795730|Other|placebo|
16279374|NCT00796536|Behavioral|Pain education|Patients will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.
16279375|NCT00796523|Behavioral|Happiest Baby videotape|a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
16279376|NCT00796523|Behavioral|control videotape|a videotape with general newborn care instructions
16279377|NCT00796510|Drug|Sitaxsentan|Sitaxsentan = 100 mg tablet administered orally, once daily
16279378|NCT00796510|Drug|Sitaxsentan and Sildenafil|Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
16279379|NCT00796497|Drug|ondansetron|ondansetron hydrochloride (oral solution) dosage of 0.25 mg twice a day for 6 weeks followed by 0,5 mg twice a day for 6 weeks for a total observation period of 12 weeks.
16279380|NCT00796484|Drug|XL888|Administered orally
16279381|NCT00796471|Drug|Paliperidone ER|
16279382|NCT00796458|Drug|docetaxel|Given IV
16279383|NCT00796458|Drug|releasing hormone agonist therapy|Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.
16279384|NCT00796445|Drug|GSK 2132231A|IM solution, a course of 13 injections administered over 27 months
16279385|NCT00796445|Drug|Placebo|IM solution, a course of 13 injections administered over 27 months
16279386|NCT00796432|Drug|OROS paliperidone|
16279387|NCT00796419|Drug|5% human albumin|Intravenous administration of 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
16279388|NCT00796419|Drug|6% hetastarch|Intravenous administration of 250mL 6% hetastarch every 8 hours for 5 days
16279389|NCT00796393|Dietary Supplement|Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033|1 pill per day for 12 weeks
16279390|NCT00796393|Dietary Supplement|Starch of potato|1 pill per day for 12 weeks
16279391|NCT00796380|Drug|Xingnaojing|injection
16279392|NCT00796367|Drug|VI-0521|7.5 mg phentermine and 46 mg topiramate
16279393|NCT00796367|Drug|Placebo|placebo
16279394|NCT00796367|Drug|VI-0521|15 mg phentermine and 92 mg topiramate
16279395|NCT00796354|Drug|MOVICOL|sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
16279396|NCT00796354|Drug|Sugar Pill|sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
16279397|NCT00796341|Procedure|PIPELLE ENDOMETRIAL SAMPLING|Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
16279398|NCT00796328|Drug|Phenylephrine infusion|Up-down, biased coin design
16279399|NCT00796315|Drug|Doxylamine Succinate USP|One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL
16279400|NCT00796302|Drug|Methylphenidate HCl|"For children weighing less than 25 kg, the dose will be titrated at 18 mg for the first 7 days, 36 mg for the next 4 days, and, if needed, 54 mg for the next 4 days. For children weighing more than 25 kg, the dose will be titrated at 18 mg for the first 4 days, 36 mg for the next 3 days, 54 mg for the next 4 days, and 72 mg for the next 3 days.
~Once the child's optimal dose is established, he or she will continue on that dose for the rest of the 21-week trial.
~One pill is taken once daily."
16279401|NCT00796302|Drug|Risperidone|"For children weighing less than 45 kg, the dose will start at 0.5 mg at night. After 4 days, the child's dose may be increased to 1 mg a day. On Day 8, the child's dose may be increased to 1.5 mg a day. On Day 16, the child's dose may be increased to 2.0 mg a day. On Day 22, the child's dose may be increased to 2.5 mg a day.
~For children weighing more than 45 kg, the dose will start at 0.5 mg at night. After 4 days, the child's dose may be increased to 1.0 mg a day. On Day 8, the child's dose may be increased to 1.5 mg a day. On Day 12, the child's dose may be increased to 2.0 mg a day. On Day 15, the child's dose may be increased to 2.5 mg a day. On Day 18, the child's dose may be increased to 3 mg a day. On Day 23, the child's dose may be increased to 3.5 mg a day."
16279402|NCT00796302|Behavioral|Parent Management Training (PMT)|PMT will include individual parent sessions held weekly for 9 weeks, with two booster sessions to be completed during the 3-month extension. Sessions will include development of problem-solving skills and behavior management strategies, practice activities, and role-playing with the behavioral therapist.
16279403|NCT00796302|Drug|Placebo|One pill will be taken once daily for the first 4 days and then twice daily until Week 21.
16279404|NCT00796289|Drug|GnRH iontophoretic transdermal Lutrepatch|10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml
16279405|NCT00796289|Drug|GnRH iontophoretic transdermal Lutrepatch|10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml
16279406|NCT00796289|Drug|GnRH iontophoretic transdermal Lutrepatch|10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml
16279407|NCT00796289|Drug|clomiphene citrate|Oral, 50 mg daily for 5 days
16279408|NCT00796289|Drug|placebo clomiphene citrate|oral, taken for 5 days
16279409|NCT00796289|Drug|placebo GnRH patch|Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
16279410|NCT00796276|Drug|IR OROS paliperidone and ER OROS paliperidone|
16279411|NCT00796263|Drug|HAART|"2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications or Kivexa (ABC300/3TC300) orally once daily
~Dolutegravir(DTG) 50 mg orally once daily"
16279412|NCT00796250|Biological|Infliximab|Patients in this group were treated with azathioprine (AZA), infliximab, and placebo prednisolone. Infliximab was to be administered at a dose of 5 mg/kg at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions). Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
16279413|NCT00796250|Drug|AZA|Patients in this group were treated with AZA, infliximab, and placebo prednisolone. All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
16279414|NCT00796250|Drug|Placebo Prednisolone|Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.
16279415|NCT00796250|Drug|Prednisolone|Patients in this group were treated with AZA, prednisolone, and placebo infliximab. Prednisolone was to be administered by oral use, with the decreasing dose of 40 mg a day, 35 mg a day, 30 mg a day and 25 mg a day every week for each dosage, respectively; 20 mg a day for five weeks; 15 mg a day, 10 mg a day and 5 mg a day for one week for each dosage respectively, until discontinuation.
16279416|NCT00796250|Drug|AZA|Patients in this group were treated with AZA, prednisolone, and placebo infliximab. All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
16279417|NCT00796250|Biological|Placebo Infliximab|Patients in this group were treated with AZA, prednisolone, and placebo infliximab. Placebo infliximab was to be administered at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions). Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
16279418|NCT00796237|Device|Whole body vibration therapy|In their regular physiotherapy sessions, the subjects in the experimental group will receive WBV (20-240Hz, 10-minute sessions, 1 session per day, 5 sessions per week). The vibration loading will be carried out using the Fit-Vibe System (Germany), which is a vibration platform that is capable of generating vertical vibration.
16279419|NCT00796237|Other|standing on the vibration platform but no vibration will be applied|The subjects in this group will perform the same exercises on the vibration platform as in the experimental group for the same duration, but no vibration will be given.
16279420|NCT00796224|Drug|60 mg/kg azithromycin ER|subjects taken 60 mg/kg azithromycin ER
16279421|NCT00796224|Drug|30 mg/kg azithromycin IR|subjects taken 30 mg/kg azithromycin IR (Immediate Release)
16279422|NCT00796211|Drug|CRx-197|CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
16279423|NCT00796211|Drug|CRx-197|CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
16279424|NCT00796211|Drug|Nortriptyline|0.1% nortriptyline HCl topical cream
16279425|NCT00796211|Drug|Calcipotriol|0.005% calcipotriol topical cream
16279426|NCT00796211|Other|Placebo|Vehicle of CRx-197 topical cream (placebo)
16279427|NCT00796198|Drug|Xalatan+Cosopt|Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm
16279428|NCT00796198|Drug|Xalatan|Xalatan ophthalmic solution one drop at 10pm
16279429|NCT00796185|Drug|Paliperidone ER|
16279430|NCT00796172|Behavioral|Medication Adherence System (MAS)|Participants will receive individualized reports from the MAS and counseling from their doctors. The counseling will focus on adherence to blood pressure and cholesterol management medications.
16279431|NCT00796172|Behavioral|Usual Care|Participants will receive usual care from their doctors and written materials on CVD risk factors.
16279432|NCT00796159|Drug|Olmesartan medoxomil|olmesartan medoxomil 20 mg and HCTZ 12.5 mg
16279433|NCT00796133|Drug|NES/E2 gel|Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
16279434|NCT00796120|Drug|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
16279435|NCT00796120|Drug|Doxorubicin|Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression.
16279436|NCT00796120|Drug|Ifosfamide|Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression.
16279437|NCT00796107|Drug|RG1507|R1507 was administered at a dose 16 mg/kg every 3 weeks.
16279438|NCT00796107|Drug|Letrozole|Letrozole was administered orally at a dose 2.5 mg daily.
16279439|NCT00796094|Other|Ultrasound examination|Sonoelastrography is an ultrasound examination that can determine the elasticity of soft tissue. This examination takes approximately 10 minutes to complete.
16279440|NCT00796081|Drug|ER OROS paliperidone, paliperidone ER|
16279441|NCT00796068|Drug|Cyclosporine|Given IV or PO
16279442|NCT00796068|Drug|Fludarabine Phosphate|Given IV
16279443|NCT00796068|Other|Laboratory Biomarker Analysis|Correlative studies
16279444|NCT00796068|Drug|Mycophenolate Mofetil|Given IV
16279445|NCT00796068|Radiation|Total-Body Irradiation|TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)
16279446|NCT00796068|Drug|Treosulfan|Given IV
16279447|NCT00796068|Procedure|Umbilical Cord Blood Transplantation|Undergo single or double unit UCBT
16279448|NCT00796055|Drug|MEDI-547|Administered at a dose and schedule as determined by the subject's enrollment cohort as a 60 minute IV infusion as part of a 21-day treatment cycle.
16279449|NCT00796042|Other|Usual care|Subjects will be encouraged to implement the standard wound care protocol that is consistent with the National (CAWC) and Provincial (RNAO) best practice guidelines for the treatment of pressures ulcers. This wound care program will be customized to subject's needs based on the results of the assessment performed by the wound care specialist. A registered dietitian will review blood values associated with nutritional status and make recommendations for dietary changes. Wherever possible, implementation of this wound care program will be coordinated with the subjects' current health care team and appropriate referrals to home care agencies or specialists will be initiated where needed. Subjects assigned to this group will continue their current level of activity (bed rest). Any equipment or services will be obtained through the usual provider agencies.
16279487|NCT00795717|Drug|Lovaza|Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
16279488|NCT00795717|Drug|Placebo|2 capsules given twice daily
16279489|NCT00795704|Drug|Mulberry Leaf Extract|Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months
16279490|NCT00795704|Drug|Placebo|Placebo 500 mg #2 capsules by mouth three times daily
16279491|NCT00795691|Behavioral|low-carbohydrate diet|ketogenic low-carbohydrate diet in patients with type 2 diabetes
16279492|NCT00795691|Behavioral|low-fat diet|low-fat diet in patients with type 2 diabetes
16279450|NCT00796042|Other|Pressure management and Mobility program|Subjects are provided with the same customized wound care program as the usual care group and a pressure management and mobility program that is customized to the individual's needs. This program is based on an in depth home assessment performed by a registered Occupational (OT) or Physical Therapist (PT). Pressure Management Program: A qualified OT or PT will examine the subject on all in-use surfaces and observe all transfers to identify sources of friction and shear, and any strength or balance deficits, identifying what equipment/services are required to manage pressure, improve mobility, and reduce friction and shear. Mobility Program: A qualified PT will assess strength, balance, range of motion, and functional independence with transfers and other ADLs and will develop a mobility program to optimize functional independence and improve strength and balance required for safe and effective transfers. Program to be implemented within one month of this evaluation.
16279451|NCT00796029|Drug|14C-paliperidone|
16279452|NCT00796003|Drug|JNJ-30979754 15 mg/m2|JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1.
16279453|NCT00796003|Drug|JNJ-30979754 20 mg/m2|Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants.
16279454|NCT00795977|Biological|dendritic cells, OK-432|Single Group Assignment
16279455|NCT00795964|Other|Randomized application of intraoperative tidal volume|intraoperative mechanical ventilation with 6 ml/kg predicted body weight
16279456|NCT00795964|Other|Randomized application of intraoperative tidal volume|intraoperative mechanical ventilation with 12 ml/kg predicted body weight
16279457|NCT00795951|Biological|T.R.U.E. Test|48 hour application of 28 allergens and negative control
16279458|NCT00795938|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Oral Tablet With Water
16279459|NCT00795938|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Experimental Tablet With Water
16279460|NCT00795938|Drug|Sildenafil|Single Dose of 50 mg Sildenafil Experimental Tablet Without Water
16279461|NCT00795925|Drug|propiverine hydrochloride|"coated tablets containing 5 mg
~consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d."
16279462|NCT00795912|Drug|Atorvastatin|atorvastatin titrated from 10-40 mg/day over 3 months and maintained at 40mg/day for a further 3 months
16279463|NCT00795899|Drug|Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab|"Cycles 1-4 Epirubicin: 90 mg/m2, i.v. day 1 Cyclophosphamide: 600 mg/m2, i.v. day 1 Every 22d
~Cycles 5-8 Paclitaxel: 175 mg/m2, i.v., 3h-infusion day 1 Trastuzumab: 8 mg/kg i.v. at day 0 of the 5th cycle and thereafter each 6 mg/kg i.v. day 1 in the cycles 6-8 Every 22d"
16279464|NCT00795886|Drug|RAPAMYCIN|Rapamycin (RAPA, RapamuneR) (sirolimus) is an immunosuppressive agent that was approved by the FDA in 1999. It is a macrocyclic lactone that is structurally similar to Tacrolimus (FK506) and binds to the same intracellular protein as FK506, FKBP1,2,3, but it has an entirely different mechanism of action and a different principal target protein. The target of the RAPA: FKBP complex is the mammalian target of rapamycin (mTOR). Unlike the calcineurin inhibitors cyclosporine (CSA) and - FK506, RAPA exerts its effects by inhibiting growth factor-driven transduction signals in the T-cell response to alloantigen, thus preventing proliferation among T and B lymphocytes3,4.
16279465|NCT00795860|Behavioral|Weight loss - diet only|Subjects adhere to a reduced calorie diet until they lose exactly 12% of their initial body weight. After they achieve this weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program.
16279466|NCT00795860|Behavioral|Weight loss plus exercise|Subjects adhere to a reduced calorie diet and perform 4 session of endurance exercise training per week until they lose exactly 12% of their initial body weight. Exercise training consists of stationary bicycle exercise. the exercise duration and intensity ramp up over the first few weeks of training until subjects exercise 45 min per session at an intensity of 85% of their maximal heart rate. 3 of the 4 exercise session each week are supervised by an Exercise physiologist. After they achieve the 12% weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program.
16279467|NCT00795847|Drug|Preminent (losartan/hydrochlorothiazide combination drug)|Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.
16279468|NCT00795834|Dietary Supplement|High polyphenol beverage|"Antioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0
~250ml twice daily for 1 month (56 doses)"
16279469|NCT00795834|Dietary Supplement|Placebo Beverage|"Antioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0
~250ml twice daily for 1 month (56 doses)"
16279470|NCT00795821|Drug|LY2216684|Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks
16279471|NCT00795821|Drug|Placebo|Dose: 3 tablets QD for 10 weeks
16279472|NCT00795808|Drug|Metformin|500mg tds for 6 months
16279473|NCT00795808|Drug|Placebo|One tablet tds for 6 months
16279474|NCT00795808|Drug|Metformin + Clomiphene|500mg tds + Ovulatory dose for 6 months
16279475|NCT00795808|Drug|Metformin|500mg tds for 6 months
16279476|NCT00795808|Drug|Clomiphene|Ovulatory dose for 6 months
16279477|NCT00795795|Procedure|Preimplantation Genetic Screening|Preimplantation Genetic Screening
16279478|NCT00795795|Procedure|IVF without PGS|IVF without PGS
16279479|NCT00795782|Procedure|Prophylactic central lymph node dissection|prophylactic ipsilateral versus bilateral central lymph node dissection
16279480|NCT00795769|Drug|ondansetron|Given IV
16279481|NCT00795769|Other|survey administration|Correlative studies
16279482|NCT00795769|Procedure|management of therapy complications|Ondansetron IV
16279483|NCT00795756|Drug|liposome-encapsulated cytarabine (DepoCyte)|DepoCyte 50 mg injected intrathecally x6-8 (6: B-lineage, 8: T-lineage) during induction/consolidation phases
16279484|NCT00795756|Drug|Triple intrathecal therapy (TIT)|Methotrexate 12,5 mg + Cytarabine 50 mg + Prednisolone 40 mg. injected intrathecally x12 during induction/consolidation therapy
16279493|NCT00795678|Drug|capecitabine|Capecitabine is an oral prodrug of 5 deoxy-5-fluorouridine (5DFRU) that is converted to 5-fluorouracil (5-FU). 5-FU is metabolized to 5-fluoro-2-deoxyuridine monophosphate (fDUMP) and 5-fluorouridine triphosphage (FUTP) which cause cell injury. Capecitabine is supplied in 150 mg (light peach colored) and 500 mg tablets (film coated)and will be administered pre-operatively.
16279494|NCT00795678|Drug|cyclophosphamide|Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites that cross-link tumor cell DNA. Cyclophosphamide is supplied in 100 mg, 200 mg, 500 mg and 1 gram and 2 gram vials as a white powder. The drug should be reconstituted with Sterile Water for Injection, USP, and may be diluted in either normal saline or D5W. Cyclophosphamide will be mixed in 250 mL of D5W and infused over 30 minutes prior to surgery.
16279495|NCT00795678|Drug|doxorubicin hydrochloride|Doxorubicin is an anthracycline anticancer agent which mediates tumoricidal effects by intercalating into double-stranded DNA and producing structural changes that disrupt DNA and RNA synthesis. Doxorubicin is supplied in 10, 20, and 50 mg single use vials, and 150 mg multidose vials as a red-orange, lyophilized power which has a storage stability of a least two years. The dose will be given 60mg/m2 over 15 minutes of time pre-operatively.
16279496|NCT00795678|Drug|gemcitabine hydrochloride|Gemcitabine is a fluorinated deoxynucleoside prodrug which disrupts DNA synthesis and induces apoptosis in a broad number of human tumors, including breast cancer. Gemcitabine is supplied as a lyophilized powder in sterile vials containing 200 mg of 1000 mg (1 gram) of gemcitabine as the hydrochloride salt (expressed as the free base) mannitol and sodium acetate. Dosage will be 1250mg/m2, IV pre-operatively over 30 minutes.
16279497|NCT00795678|Drug|lapatinib ditosylate|: Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets with one side of the tablet plain and other side of the tablet embossed with FG HLS. Lapatinib may also be supplied as oval, biconvex, tan tablets, with no markings. Lapatinib will be administered for at least 3 days pre-operatively at 1250mg.
16279498|NCT00795678|Drug|paclitaxel|Paclitaxel will be given as an intravenous infusion (80mg/m2) the morning of surgery as specified in the protocol, diluted in 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection. Paclitaxel will be administered via an infusion control device (pump) using non-PVC tubing and connectors, such as the IV administration sets (polyethylene or polyolefin) which are used to infuse parenteral nitroglycerin.
16279499|NCT00795678|Drug|vinorelbine ditartrate|Vinorelbine (Navelbine®) is a unique semi-synthetic vinca alkaloid 3', 4-didehydro-4' deoxy-C'-norvincaleukoblastine (ditartrate) (IUPAC). The pyogen free, sterile parenteral dosage form is supplied in 10 mg/1 ml ampules/vials and 50 mg/5 ml vials. It will be administered at a dosage of 25mg/m2 IV over 10-30 minutes pre-operatively.
16279500|NCT00795678|Drug|Trastuzumab|Trastuzumab is a monoclonal immunoglobulin G1 kappa antibody which acts as a mediator of antibody-dependent cellular cytotoxicity (ADCC) agent through its high affinity, high specificity binding to extracellular domain of HER2 Receptor. Trastuzumab is supplied as a lyophilized, sterile powder containing 440 mg trastuzumab per vial under vacuum. Each carton contains one vial of 440 mg trastuzumab and one 30 ml vial of bacteriostatic water for injection, USP, 1.1% benzyl alcohol. This will be given the morning of surgery at 2mg/m2 IV over 90 minutes.
16279501|NCT00795665|Drug|bevacizumab|Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
16279502|NCT00795665|Drug|carmustine|BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
16279503|NCT00795652|Behavioral|Distance Treatment for postpartum depression|Evidence-based, cognitive behavioural intervention for women with postpartum depression
16279504|NCT00795639|Drug|Sitaxsentan|Sitaxsentan = 100 mg tablet administered orally, once daily
16279505|NCT00795639|Drug|Placebo|Sitaxsentan Placebo = 1 tablet administered orally, once daily
16279506|NCT00795626|Behavioral|Systematic education in the reduction of the risk estimate to cardiovascular events|Systematic education during 4 assessment throughout one year
16279507|NCT00795613|Drug|ESCALATED BEACOPP|Esc.BEACOPP Bleomicine10 mg/m2/ev/die 8° VP-16 200 mg/m2/ev/die1°- 3° Doxorubicine35 mg/m2/ev/die 1° Cyclophosphamide1250 mg/m2/ev/die 1° Vincristine1,4 mg/m2(max dose 2 mg)/ev/die 8° Procarbazine100 mg/m2/b.m./die 1°- 7° Prednison40 mg/m2/b.m./die 1°-14° G-CSF300mcg/die s/c from day 8 until PMN>1000/ul Recycle every 21 days Esc.R-BEACOPP as above plus Rituximab 375 mg/m2/ev/ die 1° Recycle every 21 days Baseline BEACOPP Bleomicine10 mg/m2/ev/die 8° VP-16 100 mg/m2/ev/die 1°-3° Doxorubicine25 mg/m2/ev/die 1° Cyclophosphamide650 mg/m2/ev/die 1° Vincrinstine1,4 mg/m2(max dose 2 mg)/ev/die 8° Procarbazine100 mg/m2/os/die 1°-7° Prednison40 mg/m2/os/die 1°-14° Recycle every 21 days Baseline R-BEACOPP as above plus Rituximab375 mg/m2/ev/ die 1° Recycle every 21 days
16279508|NCT00795613|Drug|CONVENTIONAL ABVD|ABVD(cycle repeats every 28 days) Doxorubicine25 mg/m2 iv days 1,15 Bleomicine10,000 units/m2 iv days 1,15 Vinblastine6 mg/m2 iv days 1,15 Dacarbazine375mg/m2 iv days 1,15 This will be given at full dose and on schedule,regardless of blood count.
16279509|NCT00795600|Drug|insulin detemir|Insulin detemir once daily plus insulin aspart at mealtime
16279510|NCT00795600|Drug|insulin NPH|Insulin NPH once daily plus insulin aspart at mealtime
16279511|NCT00795587|Drug|variation of mannitol dose|in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes
16279512|NCT00795574|Drug|infliximab|Dosing is 5mgs/kg at weeks 0,2 and 6 to complete loading dose of drug and then every 8 weeks thereafter until end of treatment phase.
16279513|NCT00795574|Drug|Placebo Comparator|5mgs /kg given IV over a minimum of 2 hours at weeks 0,2 and 6 to complete loading dose and then every 8 weeks during maintenance treatment period.
16279514|NCT00795561|Procedure|Day care|Patients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen.
16279515|NCT00795561|Procedure|Inpatient|Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.
16279675|NCT00794313|Drug|Sugar Pill|sugar pill, capsule, three times a day, 2 weeks
16279516|NCT00795548|Drug|5-Azacitidine|"5-Aza will be administered at doses of 100mg/m2 via subcutaneous injection over a period of 5 days. The total amount per treatment cycle, consisting of 5 days, is 500mg/m². Each treatment cycle is repeated every 28 days, with a treatment pause of 23 days between each 5-Aza cycle, to a total of 6 (optional 8 cycles) cycles.
~DLI will be transfused on day +34 with a total count of CD3+ cells of DLI 1-5x10E6CD3+/kg bodyweight. In absence of GvHD DLI transfusion is repeated on day +90 with DLI 1-5x10E7CD3+/kg bodyweight and on day +142 with DLI 1-5x10E8CD3+/kg bodyweight. Additional DLI may be given."
16279517|NCT00795522|Drug|Desloratadine|Subjects will receive DL 5 mg daily for 28 days. Each active DL tablet contains 5 mg of desloratadine
16279518|NCT00795509|Drug|Tolterodine tartrate|"Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows.  The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability."
16279519|NCT00795496|Procedure|Histamine provocation|A dosimetric histamine challenge test in which the provocative dose of inhaled histamine producing a decrease of 15% in FEV1 is measured.
16279520|NCT00795496|Procedure|Skin prick tests|Skin prick testing will be performed for: birch, timothy, mugwort, alder, pine, cat, dog, horse, house dust mite, Cladosporium herbarum.
16279521|NCT00795496|Procedure|Serum IgE blood testing|One blood test to measure total serum IgE
16279522|NCT00795496|Procedure|Mantoux-testing|Tuberculin (2 TU) s.c. on the forearm. The test is read after 72 hours.
16279523|NCT00795483|Drug|Zoledronic acid|Zoledronic Acid 5mg/year
16279524|NCT00795483|Behavioral|Lifestyle modifications|Lifestyle modifications
16279525|NCT00795483|Drug|Zoledronic acid|Zoledronic acid (5mg/2years)
16279526|NCT00795470|Drug|Antimicrobial|Appropriate antimicrobial based on urine culture results
16279527|NCT00795470|Device|Catheter change|Change urine catheter
16279528|NCT00795457|Biological|GAA/TT-peptide vaccine and poly-ICLC|Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
16279529|NCT00795457|Biological|GAA/TT-peptide vaccine and poly-ICLC|Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
16279530|NCT00795444|Drug|maraviroc|Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
16279531|NCT00795418|Biological|Placebo|Placebo comparator
16279532|NCT00795418|Biological|CAD106|
16279533|NCT00795405|Behavioral|Exposure to sporting events|Exposure to sporting events
16279534|NCT00795405|Behavioral|No exposure to sporting events|No exposure to sporting events
16279535|NCT00795392|Other|ASA scale|ASA scale evaluation before operation
16279536|NCT00795392|Other|Full-scale psychological assessment|Full-scale psychological evaluation before operation
16279537|NCT00795379|Behavioral|Interoceptive Exposure|Exposure to internal stimuli.
16279538|NCT00795366|Drug|arginine vasopressin|Titrated to cerebral perfusion pressure greater than 60 mm Hg
16279539|NCT00795366|Drug|Standard catecholamine|Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
16279540|NCT00795353|Drug|Amevive exposure|Commercial alefacept prescribed by Physician
16279541|NCT00795340|Drug|carboplatin|Given IV
16279542|NCT00795340|Drug|cediranib maleate|Given orally
16279543|NCT00795340|Drug|paclitaxel|Given IV
16279544|NCT00795340|Other|placebo|Given orally
16279545|NCT00795327|Device|Sculptra (Poly-L-Lactic Acid Dermal Implant)|Drug Device study
16279546|NCT00795314|Drug|Fentanyl Citrate|Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)
16279547|NCT00795314|Drug|Butorphanol Tartrate|Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)
16279548|NCT00795301|Drug|Capecitabine, Cetuximab, Oxaliplatin|
16279549|NCT00795288|Drug|Simvastatin, 80 mg/day for 21 days|Active treatment group
16279550|NCT00795288|Drug|placebo|Control group
16279551|NCT00795275|Drug|Sitagliptin Phosphate|Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
16279552|NCT00795262|Drug|Quinapril (Accupril) plus Alpha Lipoic Acid|Patients in Arm 2 (n=20) will receive quinapril 40 mg and Alpha Lipoic Acid (600 mg/day)for an 8-week treatment period (Treatment A).
16279553|NCT00795262|Drug|accupril, placebo|accupril 40 mg
16279554|NCT00795262|Drug|accupril, alpha lipoic acid|accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg
16279555|NCT00795249|Behavioral|smoking cessation|After baseline examination, the group is asked to quit smoking for 2 weeks.
16279556|NCT00795236|Drug|Melatonin|One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.
16279557|NCT00795223|Drug|morphine and bupivacaine|0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
16279558|NCT00795223|Drug|spinal morphine and marcaine|0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
16279559|NCT00795223|Drug|morphine and bupivacaine|0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
16279560|NCT00795223|Drug|morphine and bupivacaine|0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
16279561|NCT00795210|Drug|Growth hormone|Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
16279562|NCT00795210|Drug|Growth Hormone Releasing Hormone|Tesamorelin (GHRH) 2mg SC QD x 2 weeks
16279676|NCT00794300|Device|second magnetic resonance imaging scan|
16280067|NCT00791388|Drug|PG-760564|oral capsule, 400 mg, 2x/day for 14 days
16279563|NCT00795184|Device|Imaging procedures (NBI)|"Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.
~Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.
~Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.
~After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites."
16279564|NCT00795184|Device|HDWLE|
16279565|NCT00795184|Device|pCLE|
16279566|NCT00795171|Drug|Docetaxel * Sunitinib|docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
16279567|NCT00795171|Drug|Docetaxel|docetaxel 75mg/m2 day1 q 21d x 4 cycles
16279568|NCT00795171|Drug|Docetaxel|Docetaxel 75mg/m2 q21d for 4 cycles
16279569|NCT00795158|Drug|desloratadine|desloratadine 5 mg tablets; one tablet orally once a day for 28 days
16279570|NCT00795145|Drug|Placebo|Intravenous, Placebo control for blinding, Normal Saline, Single dose
16279571|NCT00795145|Drug|Linezolid 900 mg|Intravenous, 900 mg linezolid, single dose
16279572|NCT00795145|Drug|Linezolid 1200 mg|Intravenous, 1200 mg linezolid, single dose
16279573|NCT00795145|Drug|Placebo|Intravenous, Placebo control for blinding, Normal Saline, Single dose
16279574|NCT00795145|Drug|Linezolid 600 mg|Intravenous, 600 mg linezolid, single dose
16279575|NCT00795145|Drug|Linezolid 1200 mg|Intravenous, 1200 mg linezolid, single dose
16279576|NCT00795145|Drug|Moxifloxacin 400 mg|Oral, 400 mg moxifloxacin, single dose
16279577|NCT00795132|Drug|Busulfan|This drug is a bifunctional alkylating agent. Busulfan is highly toxic to noncycling or slowly-cycling cells. Pharmacokinetic studies of the IV formulation in pediatrics have shown that using a dose of 0.8mg/kg IV q6 hours most patients will achieve AUC levels between 800 and 1300 uM/min, representing steady state levels between 600-900ug/ml. The manufacturer recommends higher doses, 1.1mg/kg for children less than 12kg. Because this is a reduced intensity study and infants on the study will be very heavily pretreated we will use the lower dose of 0.8mg/kg q6 hours for a total of 8 doses for all patients.
16279578|NCT00795132|Drug|Anti-Thymocyte Globulin|"Thymoglobulin will be administered at a dose of 2.5 mg/kg recipient body weight intravenously on each of 4 successive mornings (Days -4, -3,-2,-1) for patients receiving unrelated grafts and at a dose of 2.5mg/kg as a single dose on d-1 for patients receiving related marrow grafts. ATG is infused over a minimum of 4 hours, but is generally better tolerated over 6-8 hours. Suggested premedications are acetaminophen (10 mg/kg/dose), diphenhydramine (1 mg/kg/dose), and methylprednisolone. The methylprednisolone should be given at a dose of
~1mg/kg 30 minutes prior to the ATG, with another 1mg /kg four hours into the infusion (total 2mg/kg/d). Patients are observed continuously for possible allergic reactions throughout the infusion."
16279579|NCT00795132|Drug|Fludarabine|Administration and Dosage: Fludarabine will be administered at a dose of 30 mg/m2 in 100 ml of D5W intravenously over one hour on each of six consecutive days -10 through -5 for unrelated grafts or d-7 through d-2 for related grafts. Fludarabine is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-beta-D-arabinofuranosyladenine. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. The half-life of 2-fluoro-ara-A is approximately 10 hours. The mean total plasma clearance is 8.9 L/hr/m2 and the mean volume of distribution is 98 L/m2. Approximately 23% is excreted unchanged. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis.
16279580|NCT00795132|Drug|Cyclosporine|"Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung. The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G 0 - and G
~1 -phase of the cell cycle. Administration and Dosage: Cyclosporin start on day -3 initially at a dose of 2.5mg/kg IV q12 hours or 3mg/kg/dose (neoral equivalent) PO q12 hours targeting suggested troughs of 250 to 350 ng/ml. Continuous infusion cyclosporin may be allowed per institutional preference. 3x daily dosing may be used for younger children to achieve therapeutic levels. PBMTC Protocol #ONC0313 19 Continuous infusion cyclosporin may be allowed per institutional preference."
16279581|NCT00795132|Drug|Mycophenolate mofetil|MMF is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Administration and Dosage: Initial dosage will be IV or PO with switch to PO when tolerated. Starting doses will be 15 mg/kg/day bid (total dose 30mg/kg/d, IV same as PO dose) beginning day 0 with the first dose given approximately 4-6 hours after the stem cell infusion. This dose will stop on day +30 for patients receiving matched sibling BM/PBSC and UCB grafts, but will continue until day +40 and then taper at approximately 11%/wk over 8 weeks until patients are off at day +96.
16279582|NCT00795119|Device|Near Infrared Spectroscopy (NIRS)|NIRS of the head is undertaken at the time of CT or MRI examination
16279583|NCT00795106|Drug|Capsaicin|Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).
16279584|NCT00795106|Drug|Placebo|Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).
16279586|NCT00795054|Other|Household financial data collection|Baseline financial survey pre-transplant, financial diary post-transplant every two weeks for 3 months, and financial questionnaire via phone survey at 6, 12, 18 and 24 months post-transplant.
16279587|NCT00795028|Other|Standard Care for people after hip fracture|
16279588|NCT00795028|Other|Standard Care + exercise intervention|
16279589|NCT00795015|Drug|insulin regular IV infusion|IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared
16279590|NCT00795015|Drug|IV insulin infusion|IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared
16279591|NCT00795002|Drug|alvocidib|Given IV
16279592|NCT00795002|Drug|mitoxantrone hydrochloride|Given IV
16279593|NCT00795002|Drug|cytarabine|Given IV
16279594|NCT00795002|Other|pharmacological study|Correlative studies
16279595|NCT00795002|Other|laboratory biomarker analysis|Correlative studies
16279596|NCT00794989|Dietary Supplement|Ground Flaxseed|Given orally
16279597|NCT00794989|Other|No Intervention|Participants randomized to Arm 2 do not receive any intervention
16279598|NCT00794976|Drug|Dexamethasone Iontophoretic Patch (low dose)|
16279599|NCT00794976|Drug|Dexamethasone Iontophoretic Patch (high dose)|
16279600|NCT00794976|Drug|Dexamethasone Passive Patch|
16279601|NCT00794976|Drug|Placebo Patch|
16279602|NCT00794963|Drug|Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan|The intervention in the 4 patients consisted in dietary recommendations, advice regarding increasing physical activity, and use of Orlistat 60 mg three times daily. No other drugs were prescribed.
16279603|NCT00794963|Other|As selected by community physician|As selected by community physician
16279604|NCT00794950|Drug|Sunitinib|"Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.
~Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG (3 week course every 6 months for 2 years). Those failing (progression, intolerance) initial/secondary treatments will be offered alternative therapy."
16279605|NCT00794924|Dietary Supplement|VSL#3|one sachet per day, for 45 consecutive days
16279606|NCT00794924|Dietary Supplement|placebo|one sachet per day, for 45 consecutive days
16279607|NCT00794911|Behavioral|Quality of Life Therapy|8 weekly individual counseling sessions
16279608|NCT00794911|Behavioral|Supportive Therapy|8 weekly individual counseling sessions
16279609|NCT00794898|Biological|Infliximab (Remicade)|Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6. All patients will continue to receive the same dose of MTX they were receiving at entry throughout the subsequent treatment period.
16279610|NCT00794885|Drug|Enalapril/folic acid|Enalapril/folic acid, (10mg enalapril/0.8mg folic acid)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed.
16279611|NCT00794885|Drug|Enalapril maleate|Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.
16279612|NCT00794872|Other|blood sampling|
16279613|NCT00794859|Drug|Sorafenib|400mg twice daily
16279614|NCT00794846|Drug|Desloratadine 5 mg (Clarinex)|Clarinex 5 mg daily x 7 days
16279615|NCT00794846|Drug|Cetirizine (Zyrtec)|Zyrtec 10 mg daily x 7 days
16279616|NCT00794820|Drug|Fludarabine Phosphate|25 mg/m^2 by vein over 5-30 minutes daily for 3 days (days 2-4)
16279617|NCT00794820|Drug|Cyclophosphamide|250 mg/m^2 by vein over 60 minutes daily for 3 days (days 2-4)
16279618|NCT00794820|Drug|Rituximab|375 mg/m^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m^2 on days 2-3
16279619|NCT00794807|Drug|Alefacept|Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.
16279620|NCT00794794|Drug|Desloratadine (Clarinex)|Each subject received 5 mL of desloratadine syrup one time
16279621|NCT00794794|Drug|Cetirizine (Zyrtec)|Each subject received 5 mL of cetirizine syrup
16279622|NCT00794781|Drug|E6201|E6201 Part A (Dose Escalation): Intravenous (IV) infusion administered over 30 minutes once weekly for 3 weeks (Days 1, 8, and 15). The first 3 to 6 subjects of the first cohort will receive 20 mg/m^2/week for a cycle of 3 weeks followed by a 1-week rest period. Subsequent dose escalations may increase at increments of 100% until two Grade 2 toxicities or 1 dose-limiting toxicity (DLT) are observed in a dose group. Thereafter, doses will be increased in increments of 50% or less until the maximum tolerated dose (MTD) is determined. Part B (MTD Expansion): After the MTD is determined in Part A, 15 additional subjects will continue to receive cycles at the MTD.
16279623|NCT00794768|Drug|desloratadine 5 mg|Clarinex 5 mg daily x 7 days
16279624|NCT00794768|Drug|fexofenadine|Allegra 180 mg daily x 7 days
16279625|NCT00794755|Dietary Supplement|Vitamin K1 (Phytonadione)|Vitamin K1 tablets (100 micrograms per tablet) will be taken by patients randomized to the Vitamin K arm. Dosage is two tablets per day (200 micrograms per day) to be taken with warfarin for the 6 month study period.
16279626|NCT00794755|Dietary Supplement|Placebo|Lactose-based placebo tablets (identical in appearance to the Vitamin K1 tablets) will be taken by patients randomized to the placebo arm. Dosage is two tablets per day to be taken with warfarin for the 6 month study period.
16279627|NCT00794716|Drug|NRL972|Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.
16279628|NCT00794703|Drug|micafungin (Mycamine)|Intravenous
16279629|NCT00794703|Drug|itraconazole|oral
16279630|NCT00794690|Drug|Cimicifuga racemosa extract for the group|40 mg of Cimicifuga racemosa extract daily dor 12 months
16279631|NCT00794677|Drug|ezetimibe|Blinded study medication (ezetimibe 10 mg in tablet form) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
16279632|NCT00794677|Drug|placebo|Blinded study medication (matched placebo) will be taken orally once daily in the morning on rising. Single-blind ezetimibe placebo will be taken during the Run-In Period. Patients will be issued one bottle containing either active drug or placebo for each treatment period.
16279633|NCT00794664|Drug|Mipomersen|200 mg (1 mL), weekly subcutaneous injections for 26 weeks
16279634|NCT00794664|Drug|Placebo|1 mL weekly subcutaneous injections for 26 weeks
16279635|NCT00794638|Drug|SyB L-0501|The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
16279636|NCT00794638|Drug|Rituximab|The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
16279637|NCT00794625|Drug|Valproate|Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks
16279638|NCT00794625|Drug|Risperidone|Standard therapeutic doses of risperidone for 8 weeks
16279639|NCT00794625|Drug|Placebo|An inactive substance at identical dosing to active treatments for 8 weeks
16279640|NCT00794625|Drug|Stimulant medication|Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine
16279641|NCT00794625|Behavioral|Behavioral family counseling|Weekly behavioral counseling with a therapist
16279642|NCT00794612|Drug|Dermacyd Femina Pocket BR (Lactic Acid)|Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days
16279643|NCT00794599|Drug|Desloratadine 5 mg (Clarinex)|Clarinex 5 mg daily x 7 days
16279644|NCT00794599|Drug|Cetirizine (Zyrtec)|Zyrtec 10 mg daily x 7 days
16279645|NCT00794586|Drug|FTI, AZLI|Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
16279646|NCT00794586|Drug|Placebo, AZLI|Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
16279647|NCT00794573|Drug|varenicline|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
16279648|NCT00794573|Other|placebo|0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
16279649|NCT00794560|Behavioral|patient education|"Possible, individualized interventions:
~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
~First self-injection under control of a specially trained pharmacist"
16279650|NCT00794547|Drug|Calcitriol|Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days.
16279651|NCT00794547|Drug|Calcitriol|In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy
16279652|NCT00794508|Biological|ADA gene transfer|Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene.
16279653|NCT00794495|Drug|Desloratadine 5 mg (Clarinex)|Clarinex 5 mg daily x 7 days
16279654|NCT00794495|Drug|Cetirizine (Zyrtec)|Zyrtec 10 mg daily x 7 days
16279655|NCT00794482|Drug|NRL972|Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.
16279656|NCT00794469|Other|Water|Children will drink 10 cc/kg of cold water(4 degrees centigrade)
16279657|NCT00794456|Drug|Passiflora ; Crataegus and Salix|1 tablet PO twice a day
16279658|NCT00794456|Drug|Valeriana|1 tablet PO twice a day
16279659|NCT00794443|Drug|YM529 / ONO-5920|Oral
16279660|NCT00794430|Drug|V3381|100 mg capsules, titrated to a maximum of 400 mg bid for 13 weeks
16279661|NCT00794430|Drug|Placebo|Capsule, bid, for 13 weeks
16279662|NCT00794417|Drug|Aflibercept|Administered in combination with the other two interventions via intravenous infusion.
16279663|NCT00794417|Drug|Pemetrexed|Administered in combination with the other two interventions via intravenous infusion.
16279664|NCT00794417|Drug|Cisplatin|Administered in combination with the other two interventions via intravenous infusion.
16279665|NCT00794391|Behavioral|Motivational interviewing|Motivational interviewing is a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller & Rollnick. 1993). This 45 minutes individual motivational intervention focuses on risky injection practices.
16279666|NCT00794391|Behavioral|Educational intervention|The educational intervention is a 45 minutes individual intervention based on a document written by the Québec ministry of health (Québec, Canada). The aim is to inform participants about safe injection practices and to show them how to use sterile injection equipment.
16279667|NCT00794378|Drug|Desloratadine (Clarinex)|Each subject received 5 mL of desloratadine syrup one time
16279668|NCT00794378|Drug|Cetirizine (Zyrtec)|Each subject received 5 mL of cetirizine syrup
16279669|NCT00794365|Drug|Varenicline|"There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows:
~Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily
~Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water."
16279670|NCT00794339|Drug|64Cu-ATSM|
16279671|NCT00794339|Drug|FDG|
16279672|NCT00794326|Drug|Solution for Peritoneal Dialysis|Treatment with one bag per day during 6 months
16279673|NCT00794313|Drug|Amantadine 300 mg|Amantadine, 300 mg, capsule, three times a day, two weeks
16279674|NCT00794313|Drug|Topiramate|Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week
16279677|NCT00794287|Other|Taking blood samples|No intervention is done. Only blood samples are taken.
16279678|NCT00794274|Drug|CC-100004|After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis.
16279679|NCT00794261|Drug|Injection of Pegfilgrastim|Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
16279680|NCT00794261|Drug|Injection of Filgrastim|Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)
16279681|NCT00794248|Drug|desloratadine 5 mg|Clarinex 5 mg daily x 7 days
16279682|NCT00794248|Drug|fexofenadine|Allegra 180 mg daily x 7 days
16279683|NCT00794235|Drug|Sorafenib (Nexavar), Dacarbazine (DTIC)|"Sorafenib: 2x400 mg daily PO (2 tablets (200 mg each) each AM and PM). DAY 1-56.
~DTIC: 1-hour IV infusion 1000mg/m2 DAY 14 and 42."
16279684|NCT00794222|Device|Mobile Tracking Young People's Experiences (mobiletype)|A mobile phone self-monitoring program, based on momentary sampling techniques, that prompts young people to complete it four times a day. The program asks several questions about daily activities, mood, stress, eating and exercise.
16279685|NCT00794209|Drug|i.v fentanyl, AeroLEF|"i.v fentanyl
~5 mL of AeroLEF in Opti-Mist 750E continuous flow nebulizers (Maersk Medical Inc., (USA), McAllen, Texas)
~5 mL, of AeroLEF in Misty-Neb continuous flow nebulizers (Allegiance Healthcare Corp., McGaw Park, Illinois)
~5 mL of AeroLEF in PARI LC-Plus continuous flow nebulizers (PARI Respiratory Equipment Inc., London, Ontario)
~3 mL, of AeroLEF in AeroEclipse breath-actuated nebulizers (Trudell Medical International, London, Ontario) - reference device."
16279686|NCT00794196|Behavioral|Pharmaceutical care program for antidepressant treatment|The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.
16279687|NCT00794183|Device|CRT device settings|Comparision of A-V delay settings
16279688|NCT00794170|Behavioral|Telephone and Print based intervention|Thiss intervention consisted of tailored phone calls and follow-up mailings.
16279689|NCT00794157|Drug|Indacaterol 150 μg capsules|Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16279690|NCT00794157|Drug|Indacaterol 300 μg capsules|Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16279691|NCT00794157|Drug|Placebo capsules|Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16279692|NCT00794144|Drug|Olopatadine Hydrochloride Nasal Spray 0.6%|one spray in each nostril twice daily for 2 weeks
16279693|NCT00794144|Drug|Olopatadine Hydrochloride Nasal Spray Vehicle|one spray in each nostril twice daily for 2 weeks
16279694|NCT00794131|Biological|GL-ONC1|a genetically-engineered vaccinia virus (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase )
16279695|NCT00794118|Other|As per clinical practice|As per clinical practice
16279696|NCT00794092|Drug|Sinerem administration|Single dose
16279697|NCT00794079|Dietary Supplement|omega-3 fatty acids|4 grams per day for 8 weeks
16279698|NCT00794079|Dietary Supplement|corn oil|4 grams per day for 8 weeks
16279699|NCT00794066|Procedure|measuring the ankle brachial index|"Assessment of the ankle brachial index using the boso-ABI-system 100 (www.boso.de)."
16279700|NCT00794053|Procedure|detecting lymph node metastasis by staining|this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.
16279701|NCT00794040|Drug|Add-on citalopram following optimized methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo
16279702|NCT00794040|Drug|Add-on placebo following optimized methylphenidate|After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo
16279703|NCT00794027|Behavioral|Yoga Classes|8 weeks of yoga training that occurs 2 times per week. The patients will also perform yoga breathing at home 3 times per week.
16279704|NCT00794027|Behavioral|Yoga classes|Heart failure patients will undergo 8 weeks of yoga training 2 times per week and perform yoga breathing at home 3 times per week
16279705|NCT00794014|Procedure|Conservative strategy|"Main vessel stenting was performed.
~Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) >75% in LM subgroup.
~Side branch stenting was performed if TIMI flow <3 in the Side branch after ballooning in non-LM subgroup, and DS >50% or dissection in the Side branch after ballooning in LM subgroup."
16279706|NCT00794014|Procedure|Aggressive strategy|"Main vessel was performed.
~Side branch ballooning and kissing ballooning were done if DS >75% in the side branch after main vessel stenting in non-LM subgroup, and DS >50% in LM subgroup.
~Side branch stenting was performed if DS >50% in the side branch after ballooning in non-LM subgroup, and DS >30% or dissection in the side branch after ballooning in LM subgroup."
16279707|NCT00794001|Behavioral|Data analysis and Feedback|Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
16279708|NCT00793988|Procedure|Vibration-assisted anaesthesia|"All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.
~The vibration device and placebo will be operated by a single oculoplastics fellow. The vibrating device / placebo will be placed on the middle of the forehead 1 cm above the mid-brow point 1 second before the anaesthetic injection is commenced. It will be lifted off the skin every time the injection needle exits the skin and it will be replaced on the same point 1 second before the needle reenters the skin at a new injection site."
16279766|NCT00793624|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16279767|NCT00793624|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16279709|NCT00793988|Procedure|Switched-off vibrating device|The placebo consists of a switched-off vibrating device applied to the test site and a second identical switched-on vibrating device held close (but not touching) the first, which will therefore make the same sound. Care will be taken to ensure that the devices are out of the participants' view. The test and placebo will be randomly assigned to either the first or second eyelid; the right eyelid will be injected first in all patients, as is our routine practice.
16279710|NCT00793975|Biological|IMC-1121B|"Cohort 1
~2 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period."
16279711|NCT00793975|Biological|1121B|"Cohort 2
~4 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period."
16279712|NCT00793975|Biological|1121B|"Cohort 3
~6 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period."
16279713|NCT00793975|Biological|1121B|"Cohort 4
~8 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period."
16279714|NCT00793975|Biological|1121B|"Cohort 5
~10 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period."
16279715|NCT00793975|Biological|1121B|"Cohort 6
~13 mg/kg once a week for 4 weeks, followed by a 2-week observation period."
16279716|NCT00793975|Biological|1121B|"Cohort 7
~16 mg/kg once a week for 4 weeks, followed by a 2-week observation period."
16279717|NCT00793962|Radiation|hypofractionation radiotherapy|radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
16279718|NCT00793962|Radiation|conventional fractionation radiotherapy|50Gy/25/f/5w
16279719|NCT00793923|Drug|ranibizumab and dexamethasone|Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection
16279720|NCT00793923|Drug|Ranibizumab|intravitreal injection of 0.5 mg ranibizumab
16279721|NCT00793910|Drug|Gabapentin|Gabapentin 300 mg taken by mouth thrice daily for 7 days
16279722|NCT00793910|Drug|placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
16279723|NCT00793897|Drug|BMS-754807|Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
16279724|NCT00793897|Drug|Paclitaxel|Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
16279725|NCT00793897|Drug|Carboplatin|Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
16279726|NCT00793871|Drug|Sunitinib Malate (SU011248)|Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
16279727|NCT00793858|Drug|placebo, isotonic ciclesonide, hypotonic ciclesonide|200mcg/nostril
16279728|NCT00793845|Drug|Cyclophosphamide|First HDCT
16279729|NCT00793845|Drug|Etoposide|First HDCT
16279730|NCT00793845|Drug|Carboplatin|First HDCT
16279731|NCT00793845|Drug|Thiotepa|Second HDCT
16279732|NCT00793845|Drug|Melphalan|Second HDCT
16279733|NCT00793845|Radiation|Total body irradiation|Second HDCT
16279734|NCT00793832|Behavioral|supervised exercise|supervised exercise
16279735|NCT00793832|Behavioral|Diet advice|Diet Advice
16279736|NCT00793819|Drug|silodosin|α1-adrenergic antagonist
16279737|NCT00793806|Device|Diffuse Optical Spectroscopy|Diffuse Optical Spectroscopy measurements will be compared to a variety of laboratory parameters routinely measured in Chronic Inflammation and Oxidative Stress in Chronic Kidney Disease
16279738|NCT00793793|Drug|BI201335|patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
16279739|NCT00793793|Drug|BI201335|patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
16279740|NCT00793793|Drug|BI201335|patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
16279741|NCT00793793|Drug|BI201335|patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
16279742|NCT00793793|Drug|Placebo|
16279743|NCT00793780|Drug|Naltrexone 25mg|Naltrexone 25mg caplets taken orally once a day for 8 weeks
16279744|NCT00793780|Other|Placebo|Placebo caplet (inactive substance) taken orally once a day for 8 weeks
16279745|NCT00793767|Drug|erythropoietin|bolus of 400 IU/kg
16279746|NCT00793767|Drug|placebo (saline)|i.v
16279747|NCT00793754|Drug|Aspirin|100 mg / day for 8 weeks
16279748|NCT00793754|Drug|Atorvastatin|40 mg / day for 8 weeks
16279749|NCT00793754|Drug|Aspirin + Atorvastatin|Aspirin 100 mg / day + Atorvastatin 40 mg / day for 8 weeks
16279750|NCT00793741|Drug|somatostatin|Somatostatin may be used to suppress endogenous insulin secretion
16279751|NCT00793728|Procedure|Sleeve gastrectomy|Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
16279752|NCT00793715|Procedure|Decompressive laparotomy with temporary abdominal closure|Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies
16279753|NCT00793715|Procedure|Percutaneous puncture with placement of abdominal catheter|Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus
16279754|NCT00793702|Biological|rdESAT-6 + rCFP-10|rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
16279755|NCT00793676|Other|spirometry|
16279756|NCT00793676|Other|blood test|
16279757|NCT00793663|Drug|Xenon|Inhalational gas; maximum dose allowed: 70 % Xenon; the duration of the treatment will be defined through anesthesia-time.
16279758|NCT00793663|Drug|Sevoflurane|Inhalation gas; age adapted MAC-values; the duration of the treatment will be defined through anesthesia-time
16279759|NCT00793663|Drug|Dexamethasone|Intravenous use, 4 mg, single shot
16279760|NCT00793663|Drug|NaCl|Intravenous use; single shot
16279761|NCT00793663|Drug|Ondansetron|Intravenous use; 4 mg; single shot
16279762|NCT00793663|Drug|NaCl|Intravenous use; single shot
16279763|NCT00793650|Drug|Bortezomib|Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
16279764|NCT00793650|Drug|Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days
~-3 and -2), for a total dose of 200 mg/m^2."
16279765|NCT00793650|Procedure|Autologous PBSC Transplant|Day 0 consists of the stem cell infusion.
16279768|NCT00793624|Drug|Formoterol|Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
16279769|NCT00793624|Drug|Placebo|Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
16279770|NCT00793624|Drug|Placebo|Placebo for comparison Formoterolon safety and efficacy in COPD patients
16279771|NCT00793611|Behavioral|Behavioral therapy standard of care|controls will receive usual interventions for overactive bladder: voiding diary, bladder drills, pelvic floor exercises
16279772|NCT00793611|Other|hypnotherapy|Patients will receive 3 hypnotherapy sessions in addition to usual behavioral treatment of overactive bladder
16279773|NCT00793598|Drug|Placebo|
16279774|NCT00793598|Drug|Brincidofovir|
16279775|NCT00793585|Drug|allopurinol|Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level < 6mg/dl , the dosage changed to 200mg/d.
16279776|NCT00793585|Other|continue their usual therapy|Patients will receive lifestyle modification and continue their usual therapy.
16279777|NCT00793572|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo transplantation
16279778|NCT00793572|Drug|Bortezomib|Given SC
16279779|NCT00793572|Drug|Cyclosporine|Given IV
16279780|NCT00793572|Drug|Cyclosporine|Given PO
16279781|NCT00793572|Drug|Fludarabine Phosphate|Given IV
16279782|NCT00793572|Other|Laboratory Biomarker Analysis|Correlative studies
16279783|NCT00793572|Drug|Melphalan|Given IV
16279784|NCT00793572|Drug|Mycophenolate Mofetil|Given PO
16279785|NCT00793572|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo transplantation
16279786|NCT00793572|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo transplantation
16279787|NCT00793572|Procedure|Syngeneic Bone Marrow Transplantation|Undergo transplantation
16279788|NCT00793572|Radiation|Total-Body Irradiation|Undergo radiotherapy
16279789|NCT00793559|Drug|terlipressin|1 mg of terlipressin one time only
16279790|NCT00793559|Drug|terlipressin|1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h
16279791|NCT00793546|Drug|Bosutinib|300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
16279792|NCT00793546|Drug|exemestane|25 mg tablet once daily
16279793|NCT00793546|Drug|Exemestane|25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
16279794|NCT00793520|Drug|Milnacipran|Twice daily oral administration of Milnacipran for 5 weeks.
16279795|NCT00793520|Drug|Placebo|Twice daily oral administration of placebo for 5 weeks.
16279796|NCT00793520|Drug|Placebo|Twice daily oral administration of placebo for 5 weeks.
16279797|NCT00793520|Drug|Milnacipran|Twice daily oral administration of Milnacipran for 5 weeks.
16279798|NCT00793507|Other|Oral Health Care Early Intervention Project|The intervention group will receive routine preventive dental care, 2 to 4 times per year depending on risk of caries. The intervention group will also receive pre-scheduling, reminders, and care coordination by the dental hygienist. The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. In order to determine the incidence of early childhood caries at study enrollment, both intervention and control groups will receive a standardized oral examination with an assessment of caries presence and extent on the day of enrollment, at 12 months and at 24 months after enrollment. Both children in the control group and intervention group will be referred to a dentist if found to need restorative care.
16279799|NCT00793494|Other|Probaclac|Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)
16279800|NCT00793494|Other|Placebo|Placebo composition matodextrin, gelatin, ascorbic acid, soya
16279801|NCT00793481|Device|Diffuse Optical Spectroscopy|Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
16279802|NCT00793468|Drug|GSK598809|GSK598809 once daily for 12 weeks
16279803|NCT00793468|Drug|Nicotine Replacement Transdermal Patch|All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo.
16279804|NCT00793468|Drug|Placebo|Placebo once daily for 12 weeks
16279805|NCT00793455|Behavioral|Educational outreach|Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening.
16279806|NCT00793442|Diagnostic Test|Blood Collection and Assays|The researchers will sample blood upon enrollment, at 6 and 24 hours after the baseline sampling. The researchers will measure 6 different endothelial related biomarkers compromising different components of endothelial permeability and hemostasis.
16279807|NCT00793429|Drug|Prucalopride|
16279808|NCT00793429|Other|Placebo|
16279809|NCT00793416|Device|Shunt flow detection|Shunt flow detection based upon ShuntCheck results compared to radionuclide test results
16279810|NCT00793403|Other|As per routinary clinical care|As per routine clinical care
16279811|NCT00793377|Drug|Adriamycin (Doxorubicin), Docetaxel, Tamoxifen|Adriamycin will be given at a dose 50 mg/m2 and docetaxel at a dose of 75 mg/m2 every 14 days for four cycles.Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.
16279812|NCT00793377|Drug|Adriamycin (Doxorubicin), Docetaxel, Tamoxifen, Cyclophosphamid|Adriamycin will be given at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 every 21 days for four cycles. Thereafter, docetaxel at a dose of 100 mg/m2 is given every 21 days for four cycles. Tamoxifen 20 mg is given once daily for five years to all patients, starting with the first day of chemotherapy.
16279813|NCT00793364|Dietary Supplement|Stanol ester spread|Stanol ester spread 20 g every day
16279814|NCT00793364|Dietary Supplement|Placebo spread|Placebo spread 20 g every day
16279815|NCT00793364|Dietary Supplement|Mediterranean Diet|Mediterranean Diet every day
16279816|NCT00793351|Procedure|Reduced-intensity allogeneic hematopoietic stem cell transplantation|"Treatment Scheme
~Enrollment - Pre-RIST treatment - RIST
~4 cycles of conventional chemotherapy will be given prior to RIST.
~Surgery will be done whenever possible prior to RIST.
~Local radiotherapy will be applied whenever possible prior to RIST.
~topotecan + cyclophosphamide) regimen will be used for pre-RIST conventional chemotherapy.
~Cyclophosphamide/Fludarabine (CyFlu) regimen will be used as conditioning regimen for matched related or unrelated SCT. CyFlu-ATG regimen will be used as conditioning regimen for mismatched related SCT."
16279817|NCT00793338|Drug|Sildenafil|Sildenafil 20mg three times a day for 3 months.
16279818|NCT00793325|Drug|Somatropin|"Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription.
~Frequency and duration are according to Package Insert as follows.  Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."
16279819|NCT00793299|Behavioral|Video Illness Narrative|video
16279820|NCT00793286|Procedure|Mesh fixation by staples|Mesh fixation by staples
16279821|NCT00793286|Procedure|Mesh fixation by glue|Mesh fixation by glue
16279822|NCT00793273|Drug|insulin detemir|Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
16279823|NCT00793260|Behavioral|Enhanced Support|"The Enhanced-Support Group program used lower risk thresholds for targeted outreach of individuals with chronic illness and for those likely to face discrete surgical interventions. Individuals at high financial risk but without one of the five chronic conditions were included in the Enhanced-Support Group.
~The Enhanced-Support Group received up to five initial reach attempts while the Usual-Support Group received up to three attempts.
~The Enhanced-Support Group used a 'tight loop' management structure including detailed, timely coach level feedback reports on efficiency and effectiveness."
16279824|NCT00793260|Behavioral|Usual-Support|Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification). The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs. These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.
16279825|NCT00793247|Drug|PRU-PLA-PRU-PLA|
16279826|NCT00793247|Drug|PLA-PRU-PLA-PRU|
16279827|NCT00793247|Drug|PLA-PRU-PRU-PLA|
16279828|NCT00793247|Drug|PRU-PLA-PLA-PRU|
16279829|NCT00793234|Drug|TB-402|TB-402 administered as single bolus 18-24 post total knee replacement surgery.
16279830|NCT00793234|Drug|Enoxaparin|Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
16279831|NCT00793221|Device|Implantation of sirolimus-eluting coronary stent|Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
16279832|NCT00793221|Device|Implantation of everolimus-eluting coronary stent|Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion
16279833|NCT00793208|Biological|semi-allogeneic human fibroblasts (MRC-5) transfected with DNA|"Each vaccine consists of 1 x 10e7 DNA-transfected irradiated fibroblasts. A total of 4 weekly immunizations will be delivered to each patient. Each vaccine will be administered i.d. using a 1 mL syringe and a 25 gauge needle.
~Subjects will have immunizations administered at 4 different sites for each vaccination as follows:
~Site #1: Right arm Site #2: Left arm Site #3: Right thigh Site #4: Left thigh Approximately equal numbers of transfected fibroblasts will be administered at each site."
16279834|NCT00793195|Drug|Intralipid 20%|Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally. PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child. PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain. Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point. Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation. A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped.
16279835|NCT00793195|Drug|SMOFlipid 20%|Dosing will be formulated according to a Nomogram for Parenteral Nutrition (PN) composition, which takes into account the percentage of the subject's caloric intake consumed parenterally. PN solution will be infused continuously over 12-24 hours by infusion pump, and the duration each day will depend on the enteral tolerance of the child. PN shall not be discontinued, unless the patient is taking 95% of calories enterally with good growth as evidence by appropriate weight gain. Subjects will receive the trial lipid for a total duration of 12 weeks or if they develop a serum conjugated bilirubin (sustained for 7 days) of 100 umol/l (6mg/dl) or full enteral tolerance prior to this end-point. Once the trial lipid is discontinued, in the event that PN is continued, subjects will return to the standard lipid preparation. A final follow-up data-point will be collected 4 weeks after the trial lipid is stopped.
16279836|NCT00793182|Drug|Ioversol 320 mgI/mL|125 mL of Ioversol administered in the vein
16279837|NCT00793182|Drug|Iodixanol 320 mgI/mL|125 mL of Iodixanol administered in the vein
16279838|NCT00793169|Procedure|Blood Draw|Serum levels were measured
16279839|NCT00793156|Drug|Nalfurafine HCl 2.5 µg|Daily dose of 2.5 µg
16279840|NCT00793156|Drug|Nalfurafine HCl 5.0 µg|Daily dose of 5.0 µg
16279841|NCT00793156|Other|Placebo|Placebo daily dose
16279842|NCT00793130|Dietary Supplement|Coltect|Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.
16279843|NCT00793117|Procedure|packing|packing in middle meatus for duration of 5 day
16279844|NCT00793104|Procedure|Placement of allograft CR Plug in primary injury site|Core defect and implant allograft CR plug
16279845|NCT00793091|Drug|C-KAD Ophthalmic Solution|4 drops applied daily for 120 days
16279846|NCT00793091|Drug|Placebo|4 drops applied daily for 120 days
16279847|NCT00793065|Other|Electronic health record (EHR)|Computer-based system that allows physicians to access and manage patient records electronically.
16279848|NCT00793065|Other|Medical Home redesign|Implementation of NCQA Level III Medical Home
16279849|NCT00793052|Drug|Etodalac, Etoricoxib and Dexamethasone|"Dexamethasone sodium phosphate 8 mg 1 hour before the extraction, 4 mg the day after the extraction and another 4 mg at second day to the extraction.
~Etoricoxib 120 mg 1 hour before the extraction, 120 mg the day after the extraction and another 120 mg at second day to the extraction.
~Etodalac 600 mg 1 hour before the extraction, 600 mg the day after the extraction and another 600 mg at second day to the extraction."
16279850|NCT00793026|Drug|Dermacyd Breeze Pocket BR (Lactic Acid)|Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days
16279851|NCT00793013|Device|Volume-Cycled Assist-Control (AC) mode|"Patients ventilated with volume-cycled assist-control mode with PEEP and goal FIO2 < 40%
~Rate of mandatory time-cycled, pressure controlled breaths,initially at 12 per breaths/min
~Initial tidal volume set at 8mL/kg using predicted body weight (PBW) with a goal of 6mL/kg & setting positive end-expiratory pressure (PEEP) based on level of initial FiO2
~Inspiratory to Expiratory ratio set at 1:1 to 1:3
~If frequency of triggered breaths increased greater than 10 per min sedation will be increased. If needed,rate of mandatory breaths increased
~Mgmt of PEEP will be conducted as per the ARDSnet Protocol
~Oxygenation goal PaO2: PaO2-55-80 mm Hg O2 Sat: 88-95%
~Tidal volume and respiratory rate adjusted to the desired pH and plateau pressures per ARDSnet protocol"
16279852|NCT00793013|Device|Airway Pressure Release Ventilation (APRV) mode|"Ventilation uses Drager Model X1
~Spontaneous breathing allowed throughout ventilatory cycle at 2 airway pressure levels
~Time periods for the high & low pressure levels can be set independently
~Duration of the lower pressure level will be adjusted to allow expiratory flow to decay to 75% of total volume
~Duration of higher pressure levels will be adjusted to produce 12 pressure shifts per min
~Spontaneous frequency will be targeted for 6 to 18 breaths/per min
~If spontaneous breathing is achieved,level of sedation will be decreased
~If spontaneous respirations are >20 breaths/min, sedation will be increased
~If spontaneous breathing frequency increased greater than 20/per min, sedation was increased and if needed the mechanical frequency increased"
16279853|NCT00793000|Drug|PF-04287881|75 mg oral dose (prepared solution) given once
16279854|NCT00793000|Drug|Placebo|placebo to match 75 mg oral dose (prepared solution), given once
16279855|NCT00793000|Drug|PF-04287881|150 mg oral dose (prepared solution) given once
16279856|NCT00793000|Drug|Placebo|placebo to match 150 mg oral dose (prepared solution), given once
16279857|NCT00793000|Drug|PF-04287881|300 mg oral dose (prepared solution) given once
16279858|NCT00793000|Drug|Placebo|placebo to match 300 mg oral dose (prepared solution), given once
16279859|NCT00793000|Drug|PF-04287881|750 mg oral dose (prepared solution) given once
16279860|NCT00793000|Drug|Placebo|placebo to match 750 mg oral dose (prepared solution), given once
16279861|NCT00793000|Drug|PF-04287881|1000 mg oral dose (prepared solution) given once
16279862|NCT00793000|Drug|Placebo|placebo to match 1000 mg oral dose (prepared solution), given once
16279863|NCT00793000|Drug|PF-04287881|1250 mg oral dose (prepared solution) given once
16279864|NCT00793000|Drug|Placebo|placebo to match 1250 mg oral dose (prepared solution), given once
16279865|NCT00793000|Drug|PF-04287881|1500 mg oral dose (prepared solution) given once
16279866|NCT00793000|Drug|Placebo|placebo to match 1500 mg oral dose (prepared solution), given once
16279867|NCT00793000|Drug|PF-04287881|300 mg oral dose (prepared solution) given once
16279868|NCT00793000|Drug|Placebo|placebo to match 300 mg oral dose (prepared solution), given once
16279869|NCT00793000|Drug|PF-04287881|750 mg oral dose (prepared solution) given once
16279870|NCT00793000|Drug|Placebo|placebo to match 750 mg oral dose (prepared solution), given once
16279871|NCT00793000|Drug|PF-04287881|1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
16279872|NCT00793000|Drug|Placebo|placebo to match 1000 mg oral dose (prepared solution), given once
16279873|NCT00792974|Behavioral|A brief psycho-educational intervention|"A brief (3 single sessions) psycho-educational program with cognitive-behavioral and disease self-management techniques.
~This study is an open pilot study (feasibility study) to develop a palliative psychological program for end-of-life fears in COPD, therefore all participants will be given the opportunity to receive treatment."
16279874|NCT00792961|Device|Endomicroscopy|Rigid drop-in endomicroscope imaging probe
16279893|NCT00792935|Drug|MK-0941|MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
16279894|NCT00792935|Drug|Glimepiride|Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
16279895|NCT00792935|Drug|Metformin|The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.
16279896|NCT00792922|Drug|Azithromycin|Comparison of community coverage rate
16280060|NCT00791440|Other|Standard Psychiatric Treatment|Standard psychiatric treatment.
16279897|NCT00792922|Drug|Azithromycin|Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
16279898|NCT00792909|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 1 dose
16279899|NCT00792909|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 2 doses
16279900|NCT00792896|Behavioral|family conference|family conference
16279901|NCT00792870|Behavioral|Evaluation of the Shape Up RI Campaign|The SURI Standard group will receive all of the Shape-Up RI program materials plus an organized directory of useful websites related to healthy eating, exercise, and weight control. The SURI enhanced group will receive the standard Shape-Up RI program materials plus access to 12 behavioral weight loss lessons.
16279902|NCT00792857|Drug|CTAP201 Injection|Comparison of different dose strengths of CTAP201 after single dose.
16279903|NCT00792857|Drug|Doxercalciferol|Comparison of different dose strengths of doxercalciferol after single dose.
16279904|NCT00792844|Dietary Supplement|Bio-K capsule formulation|Bio-K 1 capsule formulation daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first
16279905|NCT00792844|Dietary Supplement|Bio-K drink|Bio-K 98 g of diary-free soy beverage formulation for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first
16279906|NCT00792831|Drug|ITF2357|Histone-Deacetylase Inhibitor
16279907|NCT00792818|Drug|Curcuma domestica extracts|1,500 mg per day (oral)divided into 3 times for 28 days
16279908|NCT00792818|Drug|Ibuprofen|1,200 mg/days (oral) divided into 3 times for 28 days
16279909|NCT00792805|Drug|Indacaterol 150 µg|Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16279910|NCT00792805|Drug|Indacaterol 300 μg|Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16279911|NCT00792805|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16279912|NCT00792792|Device|Modulated Imaging|Modulated Imaging Spectroscopy
16279913|NCT00792779|Drug|Propofol|Patients in the Propofol Group (PG) will be induced with target-controlled infusion (TCI) of propofol (Diprifusor, AstraZeneca) and remifentanil (Asena PK, Cardinal Health) at the target dose of 6.0 µg.ml-1 and 8.0 ηg.ml-1, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 ηg.ml-1 and etomidate 0.5 mg.kg-1 in bolus.
16279914|NCT00792766|Drug|everolimus (RAD001)|Subjects will resume the dosing regimen that they were receiving at the completion of the initial RAD001 study.
16279915|NCT00792753|Device|Medtronic Endeavor Coronary Stent System|coronary stent implantation
16279916|NCT00792753|Device|DESyne BD Novolimus Stent System|coronary stent implantation
16279917|NCT00792753|Device|DESyne Novolimus Stent System|coronary stent implantation
16279918|NCT00792740|Drug|ITF2357|ITF2357 will be supplied as hard gelatin capsules for oral administration at the dose strength of 50 mg.
16279919|NCT00792740|Drug|Placebo capsules|Placebo will be supplied as matching capsules for oral administration with the same outer appearance
16279920|NCT00792727|Drug|ketoprofen Patch|2 topical patches applied once daily for 28 days
16279921|NCT00792727|Other|Placebo Patch|2 topical placebo patches applied once daily for 28 days
16279922|NCT00792714|Drug|Mannitol|400mg twice daily for 7 days
16279923|NCT00792701|Drug|cisplatin|Given IV
16279924|NCT00792701|Drug|gemcitabine hydrochloride|Given IV
16279928|NCT00792675|Other|Aerobic and resistance exercise training|Exercise was performed 3 times per week. It consisted of 30 minutes of treadmill exercise at approximately 85% of heartrate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.
16279929|NCT00792662|Drug|Methylphenidate|Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
16279930|NCT00792662|Drug|Placebo|Standard inactive pill.
16279931|NCT00792636|Drug|sumatriptan and naproxen sodium combination tablet|sumatriptan 85mg and naproxen sodium 500mg
16279932|NCT00792636|Drug|sumatriptan tablet|sumatriptan 85mg
16279933|NCT00792636|Drug|naproxen sodium tablet|Naproxen sodium 500mg
16279934|NCT00792623|Biological|VarilrixTM|Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
16279935|NCT00792610|Biological|hepatitis B vaccine|Recombinant HBsAg, 20mcg/ml/vial (GSK) one vial IM at Day 0, Month 1, month 6 during follow-up, respectively.
16279936|NCT00792584|Drug|etravirine|Patient receives etravirine/ placebo or efavirenz / placebo
16279937|NCT00792584|Drug|efavirenz|patient receives efavirenz / placebo or etravirine / placebo
16279938|NCT00792571|Drug|Beraprost Sodium Modified Release|
16279939|NCT00792558|Drug|BMS-817378|Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation
16279940|NCT00792532|Procedure|interventional MRI for implantation of DBS electrodes|DBS implantation will be performed entirely within a Phillips 3T MRI scanner
16279941|NCT00792532|Device|DBS electrodes|Deep brain stimulation (DBS) electrodes
16279942|NCT00792519|Behavioral|HIV support group|group support
16279943|NCT00792519|Behavioral|CBT|group cognitive behavioral treatment
16279944|NCT00792506|Drug|ITF2357|Treatment was to be administered on an inpatient basis from week 1 to week 13 and on an outpatient basis from week 14 to end of treatment. The patient had to be hospitalized on day 1 every week. The Investigator had to administer ITF 2357 in one single dose (two or three 200 mg capsules at one time) under his/her direct control.
16279945|NCT00792493|Drug|ORM-12741|Alternating panel multiple dose escalation
16280061|NCT00791427|Drug|Ranibizumab|0.05 ml of ranibizumab injected into the eye monthly for one year
16279946|NCT00792480|Behavioral|Dietary and lifestyle counseling|"The intervention group will undergo a complete history and physical with attention to prepregnancy weight, current weight, height, and BMI. At the initial visit, they will meet with a registered dietician to receive a standardized counseling session, including information on pregnancy-specific dietary and lifestyle choices. The patient will be instructed to engage in moderate intensity exercise at least 3 times per week and preferably 5 times per week. They will also receive information on the appropriate weight gain during pregnancy using the IOM guidelines. Each subject will meet with the dietician only at the time of enrollment.
~At each routine obstetric appointment, the participant's weight will be measured and charted on an IOM Gestational Weight Gain Grid in front of the participant. The healthcare provider will inform the participant if her weight gain was at the appropriate level and counsel her accordingly regarding increasing or decreasing her intake and exercise."
16279947|NCT00792467|Drug|ITF2357|ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.
16279948|NCT00792454|Behavioral|exercise training|"Subjects will undergo renal rehabilitation in the form of guided exercises 2 times per week for 3 months. Subjects will be encouraged to walk for 1 hour on their own a third day of the week.Subjects will receive recommendations for cardiovascular, weight training and stretching exercises.
~Cardiovascular and strength capabilities of all subjects will be evaluated at the initial session in order to prescribe the appropriate exercise regimen. An exercise physiologist will conduct these evaluations using the Perceived Level of Exertion Subjects will also receive education and practice in mindful meditation and a heart healthy diet.
~Subjects will be encouraged to continue exercises, meditation, and healthy eating habits after the 3-month in-center program. Subjects will receive follow-up phone calls at 3-month intervals to encourage ongoing exercise, meditation, and healthy diet."
16279949|NCT00792441|Device|intervention group|inspiratory muscle training at 50% of peak negative inspiratory muscle training (PNIP)will be performed with 6 breathe/set, 10 set/day, once a day for 28 days.
16279950|NCT00792428|Device|Real Transcranial Direct Current Stimulation|A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
16279951|NCT00792428|Device|Sham Transcranial Direct Current Stimulation|A sham current runs between two electrode positions and might affect the underlying brain tissue.
16279952|NCT00792389|Other|Warm humidified C02|Insufflation of warmed humidified gas during laparoscopic cholecystectomy
16279953|NCT00792389|Other|Cool dry C02|Insufflation of cool dry gas during laparoscopic cholecystectomy
16279954|NCT00792376|Drug|etoricoxib|etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
16279955|NCT00792376|Drug|diclofenac|diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
16279956|NCT00792363|Drug|Irinotecan|350 mg/m2 intravenously on day 1 every 3 weeks
16279957|NCT00792363|Drug|Panitumumab|9 mg/kg intravenously on day 1 every 3 weeks
16279958|NCT00792350|Drug|Sorafenib (Nexavar, BAY43-9006)|Treatment of Hepatocellular Carcinoma with Nexavar (HCC)
16279959|NCT00792337|Drug|simvastatin|10 mg per oral once daily for 8 weeks
16279960|NCT00792337|Drug|B1-6-12|1 table per day for 8 weeks
16279961|NCT00792324|Drug|Etravirine|Four 100mg tablets daily for 12-24 weeks
16279962|NCT00792324|Drug|Efavirenz|One 600mg tablet daily
16279963|NCT00792311|Procedure|Tsui test|The stimulator is set at frequency of 1Hz with 200ms pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA.
16279964|NCT00792298|Drug|Suvorexant|oral tablet taken before bedtime
16279965|NCT00792298|Drug|Dose-matched Placebo to Suvorexant|Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
16279966|NCT00792285|Behavioral|Automated Telephone Outreach with Speech Recognition|Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening
16279967|NCT00792246|Drug|voriconazole|Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.
16279968|NCT00792246|Drug|voriconazole|Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.
16279969|NCT00792233|Other|Withdrawal of anti-TNF therapy|Anti-TNF therapy will be discontinued at the third visit in children who demonstrate persistent inactive disease for at least 6 months.
16279970|NCT00792220|Procedure|MSU|"In the Mobile Stroke Unit procedure: Conventional Emergency Medical Service together with the MSU will meet at the side, where the patient is found. The MSU is an ambulance, equipped with a neurologist and neuroradiologist and includes CT scanner and point of care laboratory unit. The patient's medical history and the physical examination will be directly performed by the neurologist. CT scan analysis will be performed by the neuroradiologist, while the neurologist will analyze the blood samples with the point of care laboratory unit. If the inclusion and exclusion criteria are fulfilled, the thrombolytic therapy will directly be started by the neurologist. A possible thrombolytic therapy will be performed under the current inclusion and exclusion criteria that are associated with the rt-PA drug approval in Europe. After performance of the acute therapy, the patient will be transported to the University Hospital of the Saarland."
16279971|NCT00792220|Procedure|OCCM|In the optimized conventional clinical management: After patient's medical history, physical examination and emergency treatment by the emergency physician, the patient will be transported to the University Hospital of the Saarland. The delivery of the patient will directly take place at the CT scanner. The neurologist will perform a second medical history, physical examination, while the blood will be drawn by the assisting nurse. CT scan will be performed, while the blood will be analyzed by point of care technique, placed close to the CT scanner. Additionally the blood will be sent in parallel to the hospital central laboratory for conventional laboratory analysis. Depending on the results, a thrombolytic therapy will be initiated directly at the CT. Thereafter, the patient will be transported to the hospital Stroke Unit.
16279972|NCT00792207|Other|Virtual Coach software|The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data.
16279973|NCT00792207|Other|Activity monitor and website|The control group will use an activity monitor and a website to track activity levels.
16280062|NCT00791401|Drug|ER OROS Paliperidone|
16279974|NCT00792194|Other|Exercise training|"Subjects will be randomised in two groups:
~a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.
~a training group, where subjects are asked to exercise three times a week, whenever they want during the day."
16279975|NCT00792181|Drug|Midazolam|Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
16279976|NCT00792181|Other|Course intervention - a professional development course for caregivers.|The nursing intervention involves a professional development course for caregivers. The course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment.
16279977|NCT00792168|Drug|venlafaxine (Effexor)|venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule
16279978|NCT00792168|Other|placebo|venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule
16279979|NCT00792142|Drug|bortezomib|Given IV
16279980|NCT00792142|Drug|dexamethasone|Given orally
16279981|NCT00792142|Drug|melphalan|Given IV
16279982|NCT00792142|Drug|thalidomide|Given orally
16279983|NCT00792142|Genetic|cytogenetic analysis|Performed on baseline and post transplant bone marrow specimens
16279984|NCT00792142|Genetic|fluorescence in situ hybridization|Performed on baseline and post transplant bone marrow specimens
16279985|NCT00792142|Other|laboratory biomarker analysis|Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.
16279986|NCT00792142|Other|questionnaire administration|Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.
16279987|NCT00792142|Procedure|autologous hematopoietic stem cell transplantation|Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
16279988|NCT00792142|Procedure|peripheral blood stem cell transplantation|Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
16279989|NCT00792129|Device|The Atavi System|"The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument.
~The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used."
16279990|NCT00792116|Behavioral|Gum Chewing|
16279991|NCT00792103|Drug|NP101|NP101 study patch 4 hour application
16279992|NCT00792090|Other|Fermented milk|Formula used for non breastfed children or in complement of breastfeeding
16279993|NCT00792090|Other|Standard milk|Formula used for non breastfed children or in complement of breastfeeding
16279994|NCT00792077|Drug|Lenalidomide|5 mg daily for 56 days.
16279995|NCT00792051|Biological|Inactivated influenza vaccine|0.5ml intramuscular single dose
16279996|NCT00792051|Biological|Saline|0.5ml intramuscular, one dose
16279997|NCT00792025|Drug|sunitinib malate|
16279998|NCT00792012|Radiation|Hypofractionated Intensity-Modulated Radiation Therapy|All patients will receive one fraction of radiation therapy a day, 5 days a week, Monday through Friday. Radiation fraction size and number of fractions depend on dose fraction level the patient is assigned to.
16279999|NCT00792012|Drug|Temozolomide|Temozolomide will be administered orally, once a day starting on the first day of radiation, for 28 consecutive days during radiation, and after radiation for those patients completing radiation in less than 28 days.
16280000|NCT00791999|Drug|CDP870 400mg|400mg CDP870 given every 2 weeks until Week22 (SC)
16280001|NCT00791999|Drug|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
16280002|NCT00791999|Drug|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
16280003|NCT00791999|Drug|Placebo of CDP870|given every 2 weeks until Week22 (SC)
16280004|NCT00791986|Device|ULB , LB|"ULB: The patients breath in slowly without resistance via the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks.
~LB : The patients breath in slowly against resistance of 20 cmH2O provided by the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks."
16280005|NCT00791973|Drug|fluticasone furoate|2 puffs in each nostril once daily for 1 week
16280006|NCT00791973|Drug|Placebo|2 puffs in each nostril once daily for 1 week
16280007|NCT00791960|Drug|Dimenhydrinate|single dose, 25mg, IV, diluted in 9.5mL normal saline.
16280008|NCT00791960|Other|Placebo|single dose, 10 mL normal saline, IV
16280009|NCT00791947|Drug|CHOEP + G-CSF followed by BEAM|"CHOEP:
~Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5
~BEAM:
~Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6"
16280063|NCT00791388|Drug|Placebo|oral capsule, 2x/day for 14 days
16280064|NCT00791388|Drug|PG-760564|oral capsule, 50 mg, 2x/day for 14 days
16280065|NCT00791388|Drug|PG-760564|oral capsule, 100mg, 2x/day for 14 days
16280066|NCT00791388|Drug|PG-760564|oral capsule, 200 mg, 2x/day for 14 days
16280010|NCT00791934|Device|Stratus Microflow Ethmoid Spacer|The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.
16280011|NCT00791921|Drug|CDP870|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
16280012|NCT00791921|Drug|Placebo of CDP870|Placebo given every 2 weeks until Week22 (SC)
16280013|NCT00791908|Procedure|Electrodessication|Treatment applied to a third of the torso at each study visit.
16280014|NCT00791908|Procedure|Pulsed dye laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
16280015|NCT00791908|Procedure|potassium titanyl phosphate (KTP)|Laser treatment applied to a third of the torso at each study visit.
16280016|NCT00791895|Drug|biphasic insulin aspart 30|Treat-to-target dose titration scheme
16280017|NCT00791882|Behavioral|Social Skills Training|A program developed during 20 weeks according to adapted BELLACK 's manual (1997),including sessions in group one hour per week.
16280018|NCT00791856|Drug|testosterone|28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
16280019|NCT00791856|Drug|testosterone|14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
16280020|NCT00791843|Drug|Growth hormone releasing hormone/ placebo|12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug.
16280021|NCT00791830|Drug|Irbesartan|Tablets, 300 mg * 1 daily, 1 year
16280022|NCT00791830|Drug|Placebo matching irbesartan 150 mg|Tablets, 300 mg * 1 daily, 1 year
16280023|NCT00791817|Drug|PG-760564|200 mg capsule, single dose,fasted when dosed, duration is 4 days
16280024|NCT00791817|Drug|PG-760564|200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
16280025|NCT00791804|Drug|AeroLEF|"Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
~for nebulized administration as required by the patient.
~Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl."
16280026|NCT00791791|Procedure|standardized pain stimulus|a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
16280027|NCT00791778|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
16280028|NCT00791778|Drug|Placebo|Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
16280029|NCT00791765|Biological|Etanercept|Etanercept for subcutaneous injection.
16280030|NCT00791765|Biological|Placebo|Placebo for subcutaneous injection.
16280031|NCT00791752|Drug|AZD4017|ascending single doses (start dose 2 mg), oral suspension
16280032|NCT00791752|Drug|Placebo|Placebo
16280033|NCT00791739|Drug|trazodone, pregabalin|"phase I (from baseline to week 12): trazodone, in a starting dose of 50 mg at bedtime subsequently adjusted according to drug's efficacy and tolerability
~phase II (from week 12 to week 24): addition of pregabalin in a starting dose of 75 mg/day subsequently adjusted according to drug's efficacy and tolerability"
16280034|NCT00791713|Drug|Paliperidone ER|
16280035|NCT00791700|Drug|Maraviroc|Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
16280036|NCT00791661|Drug|MK-1006|MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.
16280037|NCT00791661|Drug|Placebo|Matching placebo to MK-1006 in a single oral dose
16280038|NCT00791648|Drug|atorvastatin|"Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
16280039|NCT00791648|Drug|placebo|"Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
16280042|NCT00791622|Drug|Paliperidone ER|
16280043|NCT00791596|Other|Ergonomic Intervention|The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design
16280044|NCT00791570|Biological|VEGFR1 and VEGFR2|Biological: VEGFR1 and VEGFR2 Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16280045|NCT00791557|Drug|Infliximab|IV drug given at weeks 1,2,14,22
16280046|NCT00791544|Drug|AVE1642|intravenous infusion
16280047|NCT00791544|Drug|sorafenib|oral intake
16280048|NCT00791544|Drug|erlotinib|oral intake
16280049|NCT00791531|Drug|Methotrexate|Oral methotrexate 5mg once daily for 5 consecutive days
16280050|NCT00791518|Drug|No intervention|No intervention
16280051|NCT00791505|Drug|ciprofloxacin|1500 mg a day for 10 days
16280052|NCT00791505|Drug|trimethoprim-sulfamethoxazole|2000 mg a day for 10 days
16280053|NCT00791492|Drug|Fx-1006A|Fx-1006A 20mg soft gelatin capsule administered orally once daily (at the same time each day) for 12 months.
16280054|NCT00791479|Drug|LY2189265 and Lifestyle Measures|Subcutaneous injection once-weekly for up to 12 weeks
16280055|NCT00791479|Drug|Placebo solution and Lifestyle Measures|Subcutaneous injection once-weekly for up to 12 weeks
16280056|NCT00791466|Dietary Supplement|Placebo|Daily placebo supplementation from enrolment <14 wk of gestation until delivery
16280057|NCT00791466|Dietary Supplement|Iodine|Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
16280058|NCT00791453|Behavioral|Education|Patients will receive literacy appropriate health information.
16280059|NCT00791440|Behavioral|Cognitive-Behavior Therapy|Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
16280068|NCT00791375|Behavioral|Physical activity intervention|Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites
16280069|NCT00791362|Other|National programme for accreditation and improvement of GP|The national programme for accreditation and improvement of general practice. This procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up. It is partly based on new theories on quality improvement, including the use of market forces and pressure for accountability. For the purpose of the study, the intervention group will be requested to focus their improvement plans in the first year on cardiovascular diseases. The control group is requested to focus their improvement plans in the first year on other domains and to provide cardiovascular care as usual.
16280070|NCT00791349|Drug|Immediate release (IR) Paliperidone|
16280071|NCT00791336|Drug|Nelfinavir|1250 mg twice daily starting for approximately 6.5 weeks.
16280072|NCT00791323|Drug|Ketorolac 0.4%|One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
16280073|NCT00791323|Drug|Lubricating Eye Drop|One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
16280074|NCT00791310|Drug|Flucis|FDG injected i.v
16280075|NCT00791297|Drug|CDB-2914|Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
16280076|NCT00791284|Drug|Intermediate release (IR) Paliperidone|
16280077|NCT00791271|Drug|Decitabine|Starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.
16280078|NCT00791271|Drug|Pegylated Interferon Alpha-2b|Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
16280079|NCT00791258|Drug|amlodipine and olmesartan medoxomil tablets|amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
16280080|NCT00791258|Drug|hydrochlorothiazide tablets|hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
16280081|NCT00791245|Biological|Particulated Juvenile Cartilage Allograft|Particulated Juvenile Cartilage Allograft
16280082|NCT00791232|Drug|extended-release (ER) OROS paliperidone|
16280083|NCT00791219|Drug|SUBA-itraconazole|100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
16280084|NCT00791219|Drug|Itraconazole|200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
16280085|NCT00791219|Drug|Placebo|Two placebo capsules taken approximately 30 minutes prior to breakfast
16280086|NCT00791206|Procedure|Real preconditioning|Preconditioning will consist of four 5 minutes cycles of upper limb ischemia interspaced with 5 minutes of reperfusion, using a blood-pressure cuff inflated to a pressure 15 mmHg greater than systolic arterial pressure.
16280087|NCT00791206|Procedure|Sham preconditioning|Preconditioning will consist of four 5 minutes cycles of upper limb ischemia interspaced with 5 minutes of reperfusion, using a blood-pressure cuff inflated to a pressure 10mmHg with the same cycling protocol as the real preconditioning.
16280088|NCT00791193|Drug|Paliperidone ER|
16280089|NCT00791167|Drug|Paliperidone ER|
16280090|NCT00791154|Drug|AMG 479|AMG 479 is administered to subjects
16280091|NCT00791154|Drug|Etoposide|Etoposide is administered to subjects
16280092|NCT00791154|Drug|Placebo|Placebo is administered with Carboplatin and Etoposide
16280093|NCT00791154|Drug|AMG 102|AMG 102 is administered to subjects
16280094|NCT00791154|Drug|Carboplatin|Carboplatin is administered to some subjects in combination
16280095|NCT00791154|Drug|Cisplatin|Cisplatin is administered to some subjects in combination
16280096|NCT00791141|Drug|Cetuximab|Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.
16280097|NCT00791128|Device|GI Liner|Medical device placed endoscopically in the duodenum, nutritional counseling
16280098|NCT00791115|Procedure|whole-mount sectioning of the prostate|A standard open retropubic radical prostatectomy will be performed. Whole fresh prostate is be embedded in gel and oriented in the anatomic position in a plastic cylinder using wood skewers. Standard pathology reports are generated from this tissue
16280099|NCT00791102|Drug|ASP-1001 nasal spray|2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
16280100|NCT00791102|Drug|Placebo for ASP-1001|2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
16280101|NCT00791089|Drug|LOVAZA Omega 3-acid ethyl esters|Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.
16280102|NCT00791089|Drug|LOVAZA|(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
16280103|NCT00791089|Other|placebo|Control group will receive placebo before & after ablation.
16280104|NCT00791076|Drug|Placebo|2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
16280105|NCT00791076|Drug|Pancreatic Polypeptide (PP)|2pmol/kg-1/min-1 PP infused continuously over 72 hours.
16280106|NCT00791063|Other|18F ML-10|Patients will undergo 2-3 brain PET/CT sessions; A pre-treatment session and 1-2 sessions post WBRT treatment. Each PET/CT session will be done following intravenous administration of 18F-ML-10, to assess tracer uptake by the tumor.
16280107|NCT00791050|Device|Allon Thermowrap. MTRE Advanced Technologies Ltd.|"Thermowrap set at 37 °C before induction of anesthesia and maintained until initiation of CPB; during CPB set to monitoring and set again to 37 °C from rewarming during CPB to end of surgery."
16280108|NCT00791037|Biological|HER-2/neu peptide vaccine|Given ID
16280109|NCT00791037|Procedure|leukapheresis|Undergo leukapheresis
16280110|NCT00791037|Biological|ex vivo-expanded HER2-specific T cells|Given IV
16280111|NCT00791037|Drug|cyclophosphamide|Given IV
16280112|NCT00791037|Biological|sargramostim|Given ID
16280113|NCT00791037|Other|laboratory biomarker analysis|Correlative study
16280114|NCT00791024|Drug|CRC-Pharma 001|50 mg
16280115|NCT00791024|Drug|lidocaine suspension|5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.
16280116|NCT00791011|Drug|AMG 655|AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
16280117|NCT00791011|Other|Vorinostat|Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
16280118|NCT00791011|Other|Bortezomib|A dipeptide boronic acid analogue with antineoplastic activity.
16280119|NCT00790998|Drug|Moxidectin|Single dose of moxidectin 2 mg oral tablet x 4
16280120|NCT00790998|Drug|Ivermectin|Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
16280121|NCT00790985|Dietary Supplement|flavocoxid|medical food
16280122|NCT00790985|Drug|Naproxen|antiinflammatory drug
16280123|NCT00790972|Drug|Sinofresh|two sprays in each nostril three times daily for one week
16280124|NCT00790972|Drug|Placebo|two sprays in each nostril three times daily for one week
16280125|NCT00790959|Behavioral|SASA!|"A community mobilization approach to try to change community and individual attitudes and behaviours that support both the perpetration of violence against women and HIV risk behaviours
~The intervention team engages with four major groups of actors: community volunteers selected from the general public; community leaders (e.g. religious, cultural and local council leaders); resource persons (health care providers, police, etc); and institutional leaders. The community volunteers are a key component of the intensive intervention."
16280126|NCT00790959|Other|Control|"Control communities will receive the full SASA! intervention after completion of the SASA! Study.
~For the duration of the study, they will receive a less intensive intervention comprising the Division-level elements of SASA! (involving community leaders, resource persons and institutional leaders) without the community volunteers."
16280127|NCT00790946|Drug|Valsartan|Valsartan 80 to 160 mg
16280128|NCT00790933|Drug|Vedolizumab|Vedolizumab intravenous infusion
16280129|NCT00790920|Drug|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
16280130|NCT00790920|Drug|Placebo|IV, single bolus over 1 - 2 minutes on 1st day
16280131|NCT00790907|Drug|fondaparinux background and standard dose UFH|Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein [GP] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
16280132|NCT00790907|Drug|Fondaparinux background and low dose heparin|Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose UFH (50 U/kg), which was not adjusted for planned GPIIb/IIIa inhibitor use or ACT). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
16280133|NCT00790907|Drug|Open label fondaparinux|Open-label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for PCI and not randomized
16280134|NCT00790894|Drug|ixabepilone|Arm A: ixabepilone will be given at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 21 days cycle.
16280135|NCT00790894|Drug|ixabepilone|Arm B: ixabepilone will be given at a dose of 20 mg/m2 as a 3-hour intravenous infusion on Days 1, 8 and 15, then 1 week off in a 28-days cycle.
16280136|NCT00790881|Drug|Artemether/Lumefantrine|Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours
16280137|NCT00790881|Drug|Artemether/ lumefantrine|Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours
16280138|NCT00790868|Drug|d-cycloserine|50mg
16280139|NCT00790868|Drug|placebo|50mg
16280140|NCT00790855|Drug|Bendamustine|Starting dose of 50 mg/m^2 through a needle or catheter in vein over 2 hours twice on Days 1-4 of every 4 week study cycle. A new study cycle may begin when blood cell counts have returned to an appropriate level or a new study cycle may begun earlier if disease gets worse or does not improve.
16280141|NCT00790842|Drug|Lenalidomide|Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity.
16280142|NCT00790842|Drug|Dexamethasone|40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity.
16280143|NCT00790842|Drug|Anticoagulants|Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
16280144|NCT00790829|Drug|transdermal nicotine patch|Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours
16280145|NCT00790816|Drug|Lapatinib in combination with an anti-cancer agent|Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
16280146|NCT00790816|Drug|Lapatinib|Lapatinib monotherapy
16280147|NCT00790816|Drug|Lapatinib in combination with an anti-cancer agent as specified by parent protocol|Lapatinib in combination with an anti-cancer agent as specified by parent protocol
16280148|NCT00790803|Drug|Pegaptanib|Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
16280149|NCT00790790|Drug|Placebo|LY545694 placebo BID po for 5 weeks
16280150|NCT00790790|Drug|LY545694 49 mg|LY545694 49 mg BID po for 5 weeks.
16280151|NCT00790790|Drug|LY545694 105 mg|LY545694 105 mg BID po for 5 weeks.
16280152|NCT00790777|Drug|Paliperidone ER|
16280153|NCT00790764|Biological|MESENDO|For the cell product, proper aliquots of each cell type will be taken to fulfill the doses established for this protocol. The two aliquots will be mixed and resuspended to a final volume of 3 ml in the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin.
16280154|NCT00790764|Other|placebo|For placebo, 3 ml of the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin will be transferred to a 5 ml syringe
16280155|NCT00790751|Drug|placebo|30 minutes orally prior to initiation of sexual activity
16280156|NCT00790751|Drug|avanafil|30 minutes orally prior to initiation of sexual activity
16280157|NCT00790751|Drug|avanafil|30 minutes orally prior to initiation of sexual activity
16280158|NCT00790751|Drug|avanafil|30 minutes orally prior to initiation of sexual activity
16280159|NCT00790738|Drug|Liothyronine (T3)|liothyronine (T3) up to 50 micrograms a day
16280160|NCT00790738|Drug|placebo|placebo
16280161|NCT00790725|Other|Proportional Assist Ventilation|Proportional Assist Ventilation will be used to ventilate the patients.
16280162|NCT00790725|Other|Pressure Support Ventilation|Pressure Support ventilation will be used to ventilate the patients.
16280163|NCT00790699|Device|I-PORT|The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
16280164|NCT00790699|Other|standard injections|The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
16280165|NCT00790686|Procedure|Insertion of Memokath 051|Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.
16280166|NCT00790673|Drug|CF 102|Oral capsules
16280167|NCT00790673|Drug|Placebo|Matching placebo capsules
16280168|NCT00790660|Drug|ASP1941|Oral
16280169|NCT00790660|Drug|Placebo|Oral
16280170|NCT00790647|Biological|filgrastim|16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection
16280171|NCT00790647|Drug|bortezomib|1.0 mg/m2/dose D -6, D-3, D +1, D + 4
16280172|NCT00790647|Drug|melphalan|100 mg/m2/dose D -2, D -1
16280173|NCT00790647|Procedure|Stem Cell Infusion|infusion of previously collected autologous stem cells
16280174|NCT00790608|Drug|Nitric Oxide|Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
16280175|NCT00790595|Drug|SU011248|5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
16280176|NCT00790595|Drug|SU011248|5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
16280177|NCT00790595|Drug|SU011248|5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
16280178|NCT00790595|Drug|SU011248|5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
16280179|NCT00790595|Drug|SU011248|5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
16280180|NCT00790582|Drug|lithium carbonate|The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
16280181|NCT00790569|Drug|nicotine|Given transdermally and orally
16280182|NCT00790569|Drug|varenicline|Given orally
16280183|NCT00790569|Other|placebo|Given orally
16280184|NCT00790556|Drug|MK8245|MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
16280185|NCT00790556|Drug|Comparator: Placebo|MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
16280186|NCT00790530|Behavioral|Automated Telephone Outreach with Speech Recognition|Automated Telephone Outreach with Speech Recognition
16280187|NCT00790530|Other|Usual Care|Usual Care
16280188|NCT00790517|Behavioral|Premier Lifestyle Intervention with DASH Diet|Comprehensive group lifestyle intervention focused on caloric restriction and increased moderate exercise using the DASH Diet. 6 months intensive intervention (weekly, group meetings) followed by 6 months of a less-intensive maintenance intervention (monthly group meetings with monthly telephone/e-mail consult)
16280189|NCT00790491|Behavioral|guidance tool for providers for lifestyle changes|automated guidance tool for medical providers involved in patient encounters addressing lifestyle changes. Addresses dietary and physical activity. Seeks to reduce cardiac disease risk.
16280190|NCT00790478|Drug|Melatonin|Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks.
16280191|NCT00790478|Other|Placebo|Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks.
16280192|NCT00790465|Dietary Supplement|dark chocolate|21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
16280193|NCT00790465|Dietary Supplement|placebo chocolate with crossover to dark chocolate|Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
16280194|NCT00790452|Drug|Aspirin|325 mg daily by mouth
16280195|NCT00790452|Drug|Placebo|Tablet daily by mouth
16280196|NCT00790439|Drug|Low Molecular Weight Sulfated Dextran|Inhibitor of instant blood-mediated inflammatory reaction
16280197|NCT00790439|Drug|Heparin|Anticoagulant
16280198|NCT00790439|Drug|Mycophenolate Mofetil|Cell proliferation inhibitor, Transplantation (immunosuppressive)
16280199|NCT00790439|Drug|Sirolimus|Cell proliferation inhibitor, immunologic (immunosuppressive)
16280200|NCT00790439|Drug|Tacrolimus|Calcineurin inhibitor
16280201|NCT00790439|Drug|Cyclosporine|Calcineurin inhibitor, immunosuppressant
16280202|NCT00790439|Drug|Daclizumab|Monoclonal IL-2 receptor blocker
16280203|NCT00790439|Drug|Basiliximab|Monoclonal IL-2 receptor blocker
16280204|NCT00790439|Biological|Allogeneic Pancreatic Islet Cells|
16280205|NCT00790426|Drug|TKI258|
16280206|NCT00790413|Drug|iodine I 131 metaiodobenzylguanidine|
16280207|NCT00790413|Drug|Fludarabine|
16280208|NCT00790413|Drug|Thiotepa|
16280209|NCT00790413|Procedure|T-cell depletion|
16280210|NCT00790413|Procedure|Haploidentical stem cell transplantation|
16280211|NCT00790413|Procedure|Donor Lymphocyte Infusion|
16280212|NCT00790413|Drug|Rituximab|
16280213|NCT00790413|Procedure|Co-transplantation of mesenchymal stem cells|
16280214|NCT00790400|Drug|Everolimus (RAD001)|Everolimus is used in 5 mg strength tablets, blister-packed under aluminum foil in units of ten tablets and dosed on a daily basis. 10mg daily dosing throughout the trial.
16280215|NCT00790400|Drug|Everolimus Placebo|Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten.
16280216|NCT00790387|Drug|Enoxaparin|Enoxaparin was administered at the commencement of PCI at a dose of 0.75 mg/kg
16280217|NCT00790387|Drug|Tirofiban|
16280218|NCT00790387|Drug|unfractionated heparin|
16280219|NCT00790374|Drug|BN83495 (Cohort 1)|20 mg daily BN83495 for 28 days
16280220|NCT00790374|Drug|BN83495 (Cohort 2)|40 mg daily BN83495 for 28 days
16280221|NCT00790374|Drug|BN83495 (Cohort 3)|60 mg daily BN83495 for 28 days
16280222|NCT00790335|Drug|Recombinant tissue plasminogen activator (rt-PA)|Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
16280223|NCT00790322|Drug|SBG|Soluble beta-1,3/1,6-glucan is a solution for oral use
16280224|NCT00790322|Other|Placebo|Solution for oral use
16280225|NCT00790309|Procedure|Weight loss surgery|Weight loss surgery
16280226|NCT00790309|Procedure|Laparoscopic abdominal surgeries|laparoscopic abdominal surgeries
16280227|NCT00790296|Drug|Thyrotropin releasing hormone (TRH)|0.5mg and 1.5mg
16280228|NCT00790296|Drug|Placebo|Saline
16280229|NCT00790283|Device|PTCA with stent implantation|"Eligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent.
~Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure."
16280230|NCT00790270|Drug|Cyclobenzaprine|5 mg orally every 8 hours as needed
16280231|NCT00790270|Drug|Ibuprofen|Ibuprofen 400 mg every 8 hours as needed
16280232|NCT00790270|Drug|Ibuprofen plus Cyclobenzaprine|Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
16280233|NCT00790257|Device|"Encapsulated human islets in a Monolayer Cellular Device"|"The product consists of isolated allogeneic human islets of Langerhans formulated in a serum-free transplant media. The islets will be encapsulated in an alginate-based Monolayer Cellular Device.
~One device will be transplanted subcutaneously and corresponds to a patch of 1-3cm². One Device per patient. No Retransplantation."
16280234|NCT00790244|Drug|doxorubicin , ifosfamide|doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
16280235|NCT00790244|Drug|doxorubicin, ifosfamide|Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
16280236|NCT00790244|Drug|doxorubicin, ifosfamide|"<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle and radiotherapy 36Gy (1.8Gy per fraction, two fractions daily) will be given between cycle 3 and four.
~(>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)"
16280237|NCT00790244|Drug|doxorubicin, ifosfamide|"<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle and radiotherapy 36Gy (1.8Gy per fraction, two fractions daily) will be given between cycle 2 and 3.
~(>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)"
16280238|NCT00790231|Device|urodynamic procedure|introduction of the urodynamic catheter into the bladder and assessment of the bladder function
16280239|NCT00790218|Drug|CF102|CF102 capsules twice daily by mouth
16280240|NCT00790205|Drug|Sitagliptin|Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.
16280241|NCT00790205|Drug|Placebo|Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.
16280242|NCT00790192|Drug|Lurasidone|Lurasidone 80 mg tablets
16280243|NCT00790192|Drug|Lurasidone|Lurasidone 4 40 mg tablets
16280244|NCT00790192|Drug|Quetiapine XR|Quetiapine XR 600mg
16280245|NCT00790192|Drug|Placebo|Matching Placebo to Lurasidone or Quetiapine
16280246|NCT00790179|Procedure|continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA|"0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.
~Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA."
16280247|NCT00790166|Device|CPAP + ThermoSmart™ humidity|an absolute humidity (AH) of 28 mg/l +/- 2mg/l
16280248|NCT00790166|Device|CPAP + Conventional humidity|an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
16280249|NCT00790166|Device|CPAP + No added humidity|ambient humidity
16280250|NCT00790153|Drug|Insulin|Insulin infusion given during 3 hours at one occasion.
16280251|NCT00790153|Drug|AZD1656|Single dose oral suspension given at one occasion.
16280252|NCT00790140|Dietary Supplement|Prosure|This is an enteral tube feed with 125 kcals & 6.65g protein per 100mls. It contains Fat, Carbohydrate, and vitamins and minerals and is enriched with 2.2g Eicosapentaenoic Acid per 500mls of feed. Patients on this trial who are randomized to Prosure will receive the product orally for 5 days prior to surgery and for 21 days post surgery vis a feeding jejunostomy tube
16280253|NCT00790140|Dietary Supplement|Ensure Plus|This is a standard enteral tube feed with 150 kcals & 6.3 g protein per 100mls as well as carbohydrate, fat and vitamins and minerals. It does not have any active immunonutrients. Patients randomized to this arm will receive the product for 5 days pre op and 21 days post surgery via a feeding jejunostomy tube
16280254|NCT00790127|Drug|HQK-1001|HQK-1001 capsules (10, 20, 30 or 40 mg) administered once a day, orally, for 56 days
16280255|NCT00790127|Drug|Placebo|Matching placebo capsules administered once a day, orally, for 56 days
16280256|NCT00790114|Drug|AZD7325|Oral, day 1-12
16280257|NCT00790114|Drug|Midazolam|single dose, twice during treatment
16280258|NCT00790114|Drug|Caffeine|single dose, twice during treatment
16280259|NCT00790101|Drug|Risedronate|
16280260|NCT00790101|Drug|Raloxifene|
16280261|NCT00790101|Other|Placebo|
16280262|NCT00790075|Drug|risperidone|liquid risperidone was administered on a mg/kg basis to a child needing seclusion. 0.015mg/kg was the start dose. Dose was increased to 0.02mg/kg if duration of episode was >30 minutes.
16280263|NCT00790062|Drug|Oxytocin|See arms
16280264|NCT00790049|Drug|ARRY-371797, p38 inhibitor; oral|single dose and multiple dose, escalating
16280265|NCT00790049|Drug|Placebo; oral|matching placebo
16280266|NCT00790036|Drug|Everolimus|Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
16280267|NCT00790036|Drug|Everolimus Placebo|Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.
16280268|NCT00790023|Drug|80 mcg Ciclesonide|80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
16280269|NCT00790023|Drug|160 mcg Ciclesonide|160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
16280270|NCT00790023|Drug|Placebo|Placebo HFA Inhaler once daily (one actuation per nostril)
16280271|NCT00790010|Drug|Bevacizumab Plus Ipilimumab Cohort 1|Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
16280272|NCT00790010|Drug|Bevacizumab Plus Ipilimumab Cohort 2|Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)
16280273|NCT00790010|Drug|Bevacizumab Plus Ipilimumab Cohort 3|Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
16280274|NCT00790010|Drug|Bevacizumab Plus Ipilimumab Cohort 4|Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)
16280275|NCT00789997|Drug|Prednisone|prednisone 40 mg daily for 10 days or placebo prednisone
16280276|NCT00789997|Drug|Etanercept|etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection
16280277|NCT00789997|Drug|levofloxacin|Levofloxacin 750 mg daily for 10 days.
16280278|NCT00789984|Device|noncontact specular microscopy|
16280279|NCT00789971|Drug|triamcinolone acetonide|40 mg of triamcinolone acetonide given inferotemporally perioperatively during phacoemulsification
16280280|NCT00789971|Drug|Maxitriol|one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g
16280281|NCT00789958|Drug|capecitabine|"Adjuvant chemotherapy: 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle
~Chemoradiotherapy: 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT"
16280282|NCT00789958|Drug|gemcitabine hydrochloride|1000 mg/m^2, IV, Days 1 & 8 of each cycle
16280283|NCT00789958|Radiation|3-dimensional conformal radiation therapy|4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
16280284|NCT00789958|Radiation|intensity-modulated radiation therapy|4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
16280285|NCT00789945|Other|Control|Study Arm A will consist of patients with Type 1 diabetes who will continue their current intensive insulin therapy regimen with no additional interventions by the investigators. Their primary care providers will continue to manage their diabetes to obtain the best control as possible of their glucose, lipids, and blood pressure. Continuous Glucose Monitoring will be monitored. No timing of premeal insulin administration will be utilized in this arm.
16280286|NCT00789945|Other|Study Arm B|"Study Arm B will include participants with type 1 diabetes which will utilize Timing to adjust their pre-meal insulin dosages. Participants will continue taking their current insulin and will be placed on a continuous glucose monitor."
16280287|NCT00789932|Behavioral|cognitive behavioral therapy|32 weeks of CBT, 1.5 hours weekly.
16280288|NCT00789932|Behavioral|Usual community care|16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.
16280289|NCT00789919|Procedure|Delivery of infant|Vaginal delivery or cesarean section, whichever is indicated
16280290|NCT00789893|Device|Vaginal Dilator|Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis & assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st & 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, & the 2nd will be one month ± 2 weeks from last day of radiation.
16280291|NCT00789880|Drug|Vitamin D3|Administration of oral vitamin D3 at 4000IU
16280292|NCT00789880|Drug|Placebo|Administration of oral Vitamin D3 placebo
16280293|NCT00789867|Drug|pGM169/GL67A|Received a nebulized dose via an breath-actuated nebulizer
16280294|NCT00789854|Drug|Quetiapine XR|300 mg once daily (od)
16280295|NCT00789854|Drug|Lithium carbonate|900 mg once daily (od)
16280296|NCT00789854|Drug|SSRI/Venlafaxine|SSRI - doses within label, Venlafaxine dose up to 225 mg/day
16280297|NCT00789841|Device|Magnetic Tracking System (MTS) and radio-opaque markers|MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.
16280298|NCT00789828|Drug|Everolimus|Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.
16280299|NCT00789828|Drug|Placebo|Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.
16280300|NCT00789815|Device|Bispectral index guide propofol infusion|"Induction:
~Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70.
~Maintenance:
~Propofol infusion (3~12 mg/kg/hour) to maintain BIS around 65~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough."
16280301|NCT00789815|Drug|Clinical-judged midazolam administration|"Induction:
~Alfentanil: 5μg/kg slowly push. Midazolam: 2 mg slowly push followed by increments of 2 mg/ 2min till OAA/S* 2~3.
~Maintenance:
~Midazolam: 2 mg/ 2min prn to keep OAA/S* 2~3 or if intolerance of procedure. Alfentanil as study arm.
~*Observer's assessment of alertness/sedation (OAA/S):
~Class 5: Responds readily to name spoken in normal tone.
~Class 4: Lethargic response to name called in normal tone.
~Class 3: Responds only to name called loudly.
~Class 2: Responds only to shaking.
~Class 1: No response to shaking."
16280302|NCT00789802|Drug|transdermal estradiol|transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
16280303|NCT00789802|Drug|naproxen|naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
16280304|NCT00789802|Drug|oral placebo|oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
16280305|NCT00789776|Procedure|Allogeneic Bone Marrow Transplantation|Undergo donor bone marrow transplantation
16280306|NCT00789776|Drug|Cyclophosphamide|Given IV
16280307|NCT00789776|Drug|Fludarabine Phosphate|Given IV
16280308|NCT00789776|Other|Laboratory Biomarker Analysis|Correlative studies
16280309|NCT00789776|Drug|Mycophenolate Mofetil|Given PO
16280310|NCT00789776|Biological|Natural Killer Cell Therapy|Given IV
16280311|NCT00789776|Drug|Tacrolimus|Given IV or PO
16280312|NCT00789776|Radiation|Total-Body Irradiation|Undergo total-body irradiation
16280313|NCT00789763|Drug|Gemcitabine|300 mg/m2/one per week, i.v., during 5 weeks.
16280314|NCT00789763|Radiation|Radiotherapy|1.8 Gy/day 5 days per week during 5 weeks (total dose 45Gy)
16280315|NCT00789763|Drug|Sorafenib|200-800 mg/day p.o. during 5 weeks
16280316|NCT00789750|Drug|Colesevelam|Colesevelam 625 mg tablets
16280317|NCT00789750|Drug|Placebo|Placebo tablets appearing to be colesevelam
16280318|NCT00789750|Drug|Pioglitazone|30 mg or 45 mg pioglitazone therapy
16280319|NCT00789737|Drug|Welchol|Welchol 625mg tablets
16280320|NCT00789737|Drug|Placebo|placebo
16280321|NCT00789724|Drug|Anakinra|100 mg daily subcutaneous injection for 14 days
16280322|NCT00789724|Drug|Placebo|0.67 ml of NaCl 0.9% subcutaneously daily for 14 days
16280323|NCT00789711|Drug|biphasic insulin aspart 30|Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
16280324|NCT00789711|Drug|insulin detemir|Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
16280325|NCT00789698|Drug|Lurasidone HC1|Lurasidone 40-160 mg/day flexibly dosed.
16280326|NCT00789698|Drug|Quetiapine XR|Quetiapine XR 200-800 mg/day flexibly dosed.
16280327|NCT00789685|Drug|Interferon Beta|Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.
16280328|NCT00789672|Drug|levodopa/carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)
16280329|NCT00789672|Device|patching|2 hours daily patching
16280330|NCT00789672|Drug|levodopa/carbidopa|Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)
16280331|NCT00789659|Other|Negative pressure dressing|A completely occlusive dressing that is attached to a device that allows a constant negative pressure of 125 mmHg to be generated.
16280332|NCT00789646|Procedure|Lidocaine/NSS|First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection
16280333|NCT00789646|Procedure|NSS/Lidocaine|First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection
16280334|NCT00789633|Drug|Masitinib|Masitinib at 9 mg/kg/day given orally twice daily
16280335|NCT00789633|Drug|Placebo|Matching placebo given orally twice daily
16280336|NCT00789633|Drug|Gemcitabine|Gemcitabine at 1000 mg/m2 by intravenous infusion
16280337|NCT00789620|Drug|lidocaine|1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h
16280338|NCT00789620|Drug|placebo|Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor
16280339|NCT00789607|Device|Transrectal APT Device or Transperineal Device will be used|Both are imaging probe devices that is inserted under local anesthetic, in the rectum using lubricant, positioning against the prostate gland, and attached to the table. This is done at baseline (Day 0) under local anesthetic with the patient in partial dorsal lithotomy position
16280340|NCT00789607|Device|TRUS probe|Patient is given local anesthetic transrectally to the prostate base and the probe is inserted with patient in the lateral decubitus position.
16280341|NCT00789594|Behavioral|laboratory monitoring alerts|laboratory monitoring alerts
16280342|NCT00789594|Behavioral|Result management module|Result management module
16280343|NCT00789581|Drug|Doxorubicin|Doxorubicin 60 mg/m2
16280344|NCT00789581|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2
16280345|NCT00789581|Drug|Ixabepilone (Ixempra)|Ixabepilone 40 mg/m2
16280346|NCT00789581|Drug|Paclitaxel (Taxol)|Paclitaxel 80 mg/m2
16280347|NCT00789568|Drug|sapropterin dihydrochloride|20 mg/kg and 100 mg/kg
16280348|NCT00789568|Drug|Moxifloxacin|Moxifloxacin is included as a positive control to demonstrate the assay sensitivity based on the expected increased QTc response.
16280349|NCT00789568|Drug|Moxifloxacin placebo|Moxifloxacin placebo tablet
16280350|NCT00789555|Drug|Olopatadine hydrochloride 0.6% nasal spray (PATANASE)|Two sprays in each nostril twice a day (morning and evening) for up to 12 months
16280351|NCT00789555|Other|Olopatadine nasal spray vehicle, pH 3.7|Two sprays in each nostril twice a day (morning and evening) for up to 12 months
16280352|NCT00789555|Other|Olopatadine nasal spray vehicle, pH 7.0|Two sprays in each nostril twice a day (morning and evening) for up to 12 months
16280353|NCT00789542|Device|Intermittent Pneumatic compression|Thigh length sleeves applied to both legs from randomization to Day 30 (Day and night) whilst sitting and lying
16280354|NCT00789542|Other|Routine care|Routine care which might include: early mobilization, adequate hydration, aspirin if ischemic stroke and graduated compression stockings according to local protocols.
16280355|NCT00789529|Device|Opti-Free® RepleniSH® MPDS|soft contact lens disinfecting solution
16280356|NCT00789529|Device|ReNu MultiPlus®|soft contact lens disinfecting solution
16280357|NCT00789503|Dietary Supplement|Bread fortified with vitamin D3 and calcium|Bread fortified with vitamin D3 (5000 IU per bun) and calcium
16280358|NCT00789490|Dietary Supplement|Daminaide 995 - SuppleFem Sprinkles|The study agent SuppleFem will be a preblend manufactured by Acatris in Oakville Ontario and will be repackaged into 1 gram aliquots in white plastic Tamper Seal Vials.1 ram to be taken with test meal
16280359|NCT00789490|Dietary Supplement|Materna|Materna is a pregnancy supplement available on the Canadian market and is manufactured by Wyeth. Dose is 1 tablet per day
16280360|NCT00789477|Procedure|Laser Photocoagulation|laser every 16 weeks as needed
16280361|NCT00789477|Drug|Intravitreal Aflibercept Injection|
16280362|NCT00789464|Dietary Supplement|Lactobacillus reuteri DSM 17938|DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
16280363|NCT00789464|Drug|trimethoprim/sulfamethoxazole|Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.
16280364|NCT00789451|Procedure|Forearm vascular study|Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
16280365|NCT00789425|Dietary Supplement|Standardized Extract of Olive Polyphenols|"Dietary supplement containing 250 mg of a standardized extract of olive polyphenols per day in 1 capsule.
~A supplement with 1000 mg calcium per day will be supplied together with the active treatment."
16280366|NCT00789425|Dietary Supplement|Placebo|Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.
16280367|NCT00789399|Drug|Fondaparinux|Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
16280368|NCT00789399|Other|Placebo|subcutaneous equivolume isotonic saline
16280369|NCT00789386|Drug|Remifentanil|Remifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes.
16280370|NCT00789386|Drug|Midazolam|Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil.
16280371|NCT00789373|Drug|Pemetrexed|Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
16280372|NCT00789373|Drug|Cisplatin|Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles
16280373|NCT00789373|Drug|Placebo|Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
16280374|NCT00789373|Drug|Pemetrexed|Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
16280375|NCT00789373|Other|Best Supportive Care|Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
16280376|NCT00789360|Drug|Inhaled Placebo|Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
16280377|NCT00789360|Drug|Inhaled Loxapine|Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
16280378|NCT00789321|Drug|Comparator: amlodipine besylate|Two 5 mg tablets amlodipine daily for 6 weeks.
16280379|NCT00789321|Drug|Comparator: Placebo|Two 5 mg tablets placebo to amlodipine daily for 6 weeks
16280380|NCT00789308|Drug|Low Molecular Weight Sulfated Dextran (LMW-SD)|Inhibitor of IBMIR
16280381|NCT00789308|Drug|Heparin|Anticoagulation
16280382|NCT00789308|Drug|CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus)|Cell proliferation inhibitor
16280383|NCT00789308|Drug|Prograf® (Tacrolimus) OR Cyclosporine|Calcineurin inhibitor
16280384|NCT00789308|Drug|Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant|
16280385|NCT00789308|Drug|Simulect® (Basiliximab) - at 2nd or 3rd transplant|Monoclonal IL-2 receptor blocker
16280386|NCT00789308|Drug|Klexane® (Enoxaparinsodium)|Anticoagulation Prophylaxis
16280387|NCT00789308|Drug|Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA)|Anticoagulation Prophylaxis
16280388|NCT00789308|Drug|Enbrel® (Etanercept)|Anti-Inflammatory Therapy
16280389|NCT00789295|Other|Mediterranean diet and Low-Carbohydrates diet|The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks
16280390|NCT00789282|Other|multidisciplinary approach|Provides an integrated, proactive approach to the management of patients with chronic diseases (ie: diabetes and sequelae) Wagner Model- care encompassed in 3 overlapping galaxies: wider community; the health care system; and the provider organization. There are 6 essential elements: community resources and policies; health care organization; patient self-management support; delivery system design; decision support; and clinical information systems.
16280391|NCT00789282|Other|multifactorial approach - for enhanced care group|optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams
16280392|NCT00789282|Other|reflects current patterns of care|"Continue under the care of their family physician and specialists with referral to diabetic assessment and treatment centers at the discretion of the patient and physician.
~Normal manner of care: could attend diabetic self education classes and consultations regarding management of diabetes. Or, participate in other patient self management program of their choice."
16280393|NCT00789269|Drug|rhubarb|14 days of rhubarb
16280394|NCT00789269|Drug|placebo|14 days of placebo
16280395|NCT00789256|Drug|Melphalan|Melphalan: 2mg orally, once daily
16280396|NCT00789256|Drug|Bortezomib|Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11
16280397|NCT00789256|Drug|Melphalan and bortezomib|
16280398|NCT00789243|Procedure|Forearm vascular study|Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
16280399|NCT00789230|Procedure|primary suture closure|primary suture closure of hernia
16280400|NCT00789230|Device|mesh enforced closure|mesh enforced closure of hernia
16280401|NCT00789217|Procedure|Immediate skin test|Intradermal test with immediate reading
16280402|NCT00789204|Other|Global Postural Re-education|The treatment in Global Postural Re-education is a global approach that seeks to identify the biomechanical cause of the problem also in other parts of the body and involves actively the patient in the postural change. Using principles like causality, globality and individuality, the treatment consists of the use for one hour of progressive active stretching posture for specific muscular chain that are shortened. Every posture is maintained for 20 minutes with controlled breathing and the use of manual traction
16280549|NCT00788125|Drug|etoposide phosphate|
16280403|NCT00789204|Other|Standard Exercise Training|The exercise programme included passive lumbar flexion, pelvic tilt, strengthening of flexor muscles, strengthening of extensor muscles, spine mobilization and stretching exercises.
16280404|NCT00789191|Drug|insulin detemir|The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.
16280405|NCT00789191|Drug|sitagliptin|The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
16280406|NCT00789191|Drug|metformin|Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
16280407|NCT00789191|Drug|sulphonylurea|Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.
16280408|NCT00789165|Drug|quinidine|quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
16280409|NCT00789165|Drug|no therapy|No therapy; this is not a placebo-controlled trial
16280410|NCT00789152|Drug|desloratadine|desloratadine 5 mg daily x 8 days
16280411|NCT00789152|Drug|levocetirizine|levocetirizine 5 mg daily x 8 days
16280412|NCT00789139|Device|ICM Implantation|Sub cutaneous implantation of the ICM
16280413|NCT00789126|Drug|VX-509|
16280414|NCT00789113|Drug|Extended Release Lamotrigine|
16280415|NCT00789087|Procedure|Videothoracoscopic talc poudrage (VT).|Videothoracoscopic talc poudrage
16280416|NCT00789087|Procedure|Talc slurry through a chest tube (DT).|Talc slurry through a chest tube
16280417|NCT00789074|Drug|Varenicline|Varenicline 1mg twice daily
16280418|NCT00789074|Drug|Placebo|Placebo 1mg BD
16280419|NCT00789061|Drug|Proton pump inhibitor|One dosage/day/year
16280420|NCT00789048|Other|radiograph|One radiograph with the patient lying on his contralateral side
16280421|NCT00789035|Drug|BI 10773|
16280422|NCT00789035|Drug|placebo|
16280423|NCT00789035|Drug|metformin|
16280424|NCT00788996|Behavioral|Brief intervention based in clinical practice guide|Minimal counseling at smoking parents with babies minor 1 year-old
16280425|NCT00788970|Behavioral|Acupressure adjuvant therapy|Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
16280426|NCT00788957|Drug|Panitumumab|Panitumumab for intravenous infusion
16280427|NCT00788957|Drug|Ganitumab|Ganitumab for intravenous infusion
16280428|NCT00788957|Drug|Rilotumumab|Rilotumumab for intravenous infusion
16280429|NCT00788957|Drug|Placebo|Placebo intravenous infusion
16280430|NCT00788944|Procedure|blood draw|Test Article was not provided to subjects for this study.
16280431|NCT00788931|Drug|IV LBH589|
16280432|NCT00788931|Drug|Oral LBH589|
16280433|NCT00788931|Drug|trastuzumab|
16280434|NCT00788931|Drug|paclitaxel|
16280435|NCT00788918|Drug|Interferon and ribavirin|Interferon 180 microgram weekly s.c. and ribavirin (800/100/1200 mg daily) p.o.
16280436|NCT00788905|Device|Allient System|The Allient System uses a different type of blood pump and a lower volume of dialysate.
16280437|NCT00788892|Drug|CPX-351|
16280438|NCT00788892|Drug|Cytarabine|
16280439|NCT00788892|Drug|Daunorubicin|
16280440|NCT00788879|Behavioral|TSSC|The intervention community is exposed to the media messages of the TSSC campaign. Residents of this community also receive the lay health worker visits as well as benefit from the positive built environment changes.
16280441|NCT00788879|Behavioral|TSSC Randomized Behavioral Intervention for weight loss|"We will enroll up to 200 weight-loss challenge participants to receive text messages on personal mobile phones throughout the challenge. Consent and enrollment in the trial will take place at registration for the weight-loss community challenge in the language of their choice. Recruited participants will be randomly assigned to a group after consenting to the study and the timing and content of text messages will vary according to group assignment (Groups A - D).
~Group A will receive weekly reminders for upcoming weigh-in events. Group B will receive the same weekly reminders but will also receive one-way messages every two weeks providing the participant motivational messages/topics and weight loss health tips. Group C will receive the same text messages as Group B but will also receive weekly prompts to self-monitor weight status. Group D will receive the same text messages as Group C plus daily prompts that will act as a guide for the participant to monitor behavior changes."
16280442|NCT00788866|Dietary Supplement|Pomegranate Juice|8 oz of pomegranate juice daily vs placebo juice identical in all respects except pomegranate
16280443|NCT00788866|Dietary Supplement|Placebo|Juice that matches the makeup of pomegranate in regards to sugar, vitamin C, etc. The only difference is that it lacks pomegranate juice.
16280444|NCT00788853|Other|No treatment given|No treatment is given
16280445|NCT00788840|Drug|Insulatard|Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
16280446|NCT00788840|Drug|Detemir|Detemir insulin used as long-acting insulin in treatment phase of study.
16280447|NCT00788827|Biological|Autologous CD34+ stem cells|Up to 5 x 10 log 8 of autologous stem cells on a single occasion
16280448|NCT00788814|Behavioral|Pathways|Strength-based curriculum addressing depression in women with with physical disabilities
16280449|NCT00788801|Drug|ABT-614|Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
16280450|NCT00788788|Drug|HELIOX|HELIOX is a mixture of Helium in Oxygen with a low density and the ability to reduce the work of breathing in subjects with airway obstruction. The fractions of Helium was altered in a different order depending on the arm of the study
16280451|NCT00788775|Drug|Nilotinib|
16280452|NCT00788749|Drug|Prednisolone|tablets 25 mg/day
16280453|NCT00788749|Drug|Placebo|tablets once daily
16280454|NCT00788749|Other|fluticasone nasal drops|fluticasone nasal drops 800mcg/d
16280455|NCT00788749|Other|fluticasone nasal spray|fluticasone nasal spray 400 mcg/d
16280499|NCT00788476|Other|Survey|"Survey packets to adult (>18 years old) childhood cancer survivors who return to MDACC for follow-up appointments within the next 12-months and conduct a mailed survey with the remaining participants and their primary caregivers i.e. guardians of survivors who are currently under age 18."
16280550|NCT00788125|Drug|ifosfamide|
16280456|NCT00788723|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) using paired-pulse technique at different interstimulus intervals (ISIs) allows the study of the excitatory and inhibitory system of human motor cortex non-invasively. Motor evoked potentials (MEP) will be recorded, and stored on a VikingSelect (Viasys Healthcare, USA). Two magnetic stimulators (Magstim 200, The Magstim Company Ltd, U.K.) connected through a Bistim and a Magstim figure-of-eight coil will be used for TMS.
16280457|NCT00788710|Drug|etoricoxib (MK0663) 120 mg|120 mg of etoricoxib (MK0663) for a total of 5 days
16280458|NCT00788710|Drug|Comparator: Placebo|Placebo tablets once daily on Days 1-5. Total treatment is 5 days.
16280459|NCT00788710|Drug|etoricoxib (MK0663) 90 mg|90 mg of etoricoxib (MK0663) for a total of 5 days
16280460|NCT00788697|Drug|SonoVue-enhanced ultrasound|Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL)
16280461|NCT00788697|Other|Unenhanced ultrasound|-Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None
16280462|NCT00788684|Drug|rituximab|IV infusion once weekly for four doses
16280463|NCT00788684|Drug|ABT-263|ABT-263: oral solution or tablets, once daily dosing until disease progression
16280464|NCT00788671|Other|Laboratory Biomarker Analysis|Correlative studies
16280465|NCT00788671|Device|Levonorgestrel-Releasing Intrauterine System|Undergo placement of a levonorgestrel-releasing intrauterine system
16280466|NCT00788671|Other|Quality-of-Life Assessment|Ancillary studies
16280467|NCT00788658|Behavioral|Diet modifications|Diet consultation
16280468|NCT00788658|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy
16280469|NCT00788645|Behavioral|COPD self care advice|Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room
16280470|NCT00788645|Behavioral|Poor weather forecast warning|Interactive automated telephone service to contact patients prior to anticipated periods of poor weather
16280471|NCT00788632|Behavioral|Patient educational DVD and brochure|"Construct a tailored direct-to-patient intervention to educate and activate older women about osteoporosis testing and treatment and aimed at improving patient-provider communication and closing the loop between knowledge communication and action. The intervention will include risk assessment, will be delivered through culturally/ethnically tailored story-telling, and will be mailed-out as both a paper copy (Booklet) and an interactive DVD (allowing the patient to use the delivery mediums they are most comfortable with). A follow-up brochure will be sent as a booster."
16280472|NCT00788632|Behavioral|Physician web modules|Web based osteoporosis continuing medical education (CME) materials
16280473|NCT00788632|Behavioral|System|Create a practice redesign strategy to alert patients that they should receive a BMD test and provide them with direct patient access to schedule their own test
16280474|NCT00788619|Procedure|Transfer of embryos on day 3 or day 5 after fertilization.|Subjects will be allocated at random to the two arms. Group 1 will have two embryos transferred on day 3 based on nitric oxide concentration. Group 2 will have two embryos transferred on day 5 based on morphologic criteria.
16280475|NCT00788619|Procedure|Day 5 transfer|Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.
16280476|NCT00788606|Drug|bevacizumab, Rituximab|6 cycles of treatment. Bevacizumab at a dose of 15 mg/kg, diluted in normal saline will be administered as a intravenous infusion over 30 to 90 minutes on Day 1 of each cycle. Rituzimab 375 mg/m2 is given as a intravenous infusion after the administration of prednisolone and before the other cytotoxic drugs on Day 1 of each cycle.
16280477|NCT00788593|Drug|Placebo|Placebo matching to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which will then be randomized to either high dose or low dose of EUR-1008 (APT-1008).
16280478|NCT00788593|Drug|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
16280479|NCT00788593|Drug|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units will be given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
16280480|NCT00788580|Drug|pazopanib hydrochloride|
16280481|NCT00788580|Drug|temsirolimus|
16280482|NCT00788580|Procedure|immunoenzyme technique|
16280483|NCT00788580|Procedure|laboratory biomarker analysis|
16280484|NCT00788580|Procedure|pharmacological study|
16280485|NCT00788567|Drug|mycophenolate mofetil|1
16280486|NCT00788554|Procedure|Lichtenstein procedure|open surgical procedure for inguinal hernia correction
16280487|NCT00788554|Procedure|TEP|Total Exta Peritoneal procedure for inguinal hernia correction
16280488|NCT00788541|Drug|Anecortave Acetate Sterile Suspension, 6 mg/mL|Administered as an injection into an anterior juxtascleral depot
16280489|NCT00788541|Drug|Anecortave Acetate Sterile Suspension, 3.75 mg/mL|Administered as an injection into an anterior juxtascleral depot
16280490|NCT00788541|Drug|Anecortave Acetate Sterile Suspension, 96 mg/mL|Administered as an injection into an anterior juxtascleral depot
16280491|NCT00788541|Drug|Anecortave Acetate Sterile Suspension, 60 mg/ML|Administered as an injection into an anterior juxtascleral depot
16280492|NCT00788541|Other|Anecortave Acetate Vehicle|Administered as an injection into an anterior juxtascleral depot
16280493|NCT00788528|Drug|S-2367 (velneperit)|Tablet, 4 x 400 mg, taken once daily with morning meal, 54-weeks
16280494|NCT00788515|Drug|Volinanserin (M100907)|2 mg tablets QD
16280495|NCT00788515|Drug|Lormetazepam|1 mg tablets (overencapsulated) QD
16280496|NCT00788502|Behavioral|Healing Touch|
16280497|NCT00788502|Behavioral|Desensitization Therapy|
16280498|NCT00788502|Behavioral|Standard Care|
16280500|NCT00788463|Drug|Intranasal Beclomethasone aerosol|Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
16280501|NCT00788463|Drug|Intranasal Beclomethasone spray|Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.
16280502|NCT00788424|Drug|AS101 Cream|4% AS101 Cream or Placebo cream, twice a day for 12 weeks
16280503|NCT00788398|Procedure|Saline Solution|Irrigation with Saline
16280504|NCT00788398|Procedure|Soap solution|Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
16280505|NCT00788398|Procedure|Gravity Flow Irrigation|Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use.
16280506|NCT00788398|Procedure|Low Pressure Irrigation|"Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound.
~Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i."
16280507|NCT00788398|Procedure|High Pressure|"Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i.
~Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i."
16280508|NCT00788385|Device|ShuntCheck test|
16280509|NCT00788372|Drug|Fentanyl|Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion.
16280510|NCT00788346|Behavioral|Computerized alerts|Computerized Clinical Decision Support to clinician at the time of prescribing
16280511|NCT00788346|Behavioral|Alerts Plus Detailing|Computerized Clinical Decision Support to clinician at the time of prescribing PLUS one group academic detailing session
16280512|NCT00788333|Drug|BMS-754807|Tablets, Oral, Dose escalation to MTD, then MTD to response/EOT, once daily, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
16280513|NCT00788333|Drug|trastuzumab (Herceptin®)|IV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
16280514|NCT00788320|Drug|Vitamin D3|Vitamin D3 50,000 IU three times a week for 8 weeks
16280515|NCT00788320|Drug|Placebo|Placebo three times a week for 8 weeks
16280516|NCT00788307|Biological|Ad5-CMV-NIS|
16280517|NCT00788307|Drug|liothyronine sodium|
16280518|NCT00788307|Genetic|reverse transcriptase-polymerase chain reaction|
16280519|NCT00788307|Other|laboratory biomarker analysis|
16280520|NCT00788307|Radiation|iodine I 131|
16280521|NCT00788294|Biological|tanezumab|Drug solution given intravenously only once at dose of 10 mg
16280522|NCT00788294|Biological|tanezumab|Drug solution given subcutaneously only once at dose of 5 mg.
16280523|NCT00788294|Biological|tanezumab|Drug solution given subcutaneously only once at dose of 10 mg.
16280524|NCT00788294|Biological|tanezumab|Drug solution given subcutaneously only once at dose of 19 mg.
16280525|NCT00788281|Procedure|laparoscopic surgery|surgery would be performed by laparoscope
16280526|NCT00788281|Procedure|open surgery|surgery would be performed by traditional surgery.
16280527|NCT00788255|Drug|Final exogenous oxytocin concentration=22.5 μU/mL|Citrated whole blood 1mL + 23μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
16280528|NCT00788255|Drug|Final exogenous oxytocin concentration=30.1μU/mL|Citrated whole blood 1mL + 31μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
16280529|NCT00788255|Drug|Final exogenous oxytocin concentration=32.9μU/mL|Citrated whole blood 1mL + 34μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
16280530|NCT00788242|Drug|Glucose-insulin-potassium|20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
16280531|NCT00788242|Drug|Placebo|60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
16280532|NCT00788229|Drug|AT01|eye drop for 12 weeks
16280533|NCT00788229|Drug|AT02|eye drop for 12 weeks
16280534|NCT00788229|Drug|AT03|eye drop for 12 weeks
16280535|NCT00788229|Drug|AT04|eye drop for 12 weeks
16280536|NCT00788216|Other|Discussion & scoring of health states related to the treatment of cervical cancer|Subjects will be interviewed using the visual analog score and time trade off methods.
16280537|NCT00788190|Procedure|Distal Radius Fracture Reduction|Surgical Intervention to Reduce Distal Radius Fracture
16280538|NCT00788190|Other|Conservative Management|Conservative management of Distal Radius Fractures
16280539|NCT00788177|Drug|Pegaptanib (Macugen®)|Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)
16280540|NCT00788164|Biological|TA-HPV|Given intramuscularly
16280541|NCT00788164|Biological|pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine|Given intramuscularly
16280542|NCT00788164|Drug|imiquimod|Given topically
16280543|NCT00788151|Biological|CYD Dengue Vaccine Serotypes 1, 2, 3, and 4|0.5 mL, Subcutaneous (SC)
16280544|NCT00788151|Biological|Pneumococcal polysaccharide vaccine|0.5 mL, SC
16280545|NCT00788138|Dietary Supplement|Vitamin D3|250,000 IU of vitamin D3
16280546|NCT00788138|Dietary Supplement|Placebo|Matching Placebo
16280547|NCT00788125|Drug|carboplatin|
16280548|NCT00788125|Drug|dasatinib|
16280551|NCT00788125|Genetic|microarray analysis|
16280552|NCT00788125|Genetic|western blotting|
16280553|NCT00788125|Other|immunohistochemistry staining method|
16280554|NCT00788125|Other|laboratory biomarker analysis|
16280555|NCT00788125|Procedure|therapeutic conventional surgery|
16280556|NCT00788125|Radiation|radiation therapy|
16280557|NCT00788112|Drug|vorinostat|
16280558|NCT00788112|Genetic|protein expression analysis|
16280559|NCT00788112|Other|immunohistochemistry staining method|
16280560|NCT00788112|Other|laboratory biomarker analysis|
16280561|NCT00788112|Procedure|neoadjuvant therapy|
16280562|NCT00788112|Procedure|therapeutic conventional surgery|
16280563|NCT00788099|Drug|Plitidepsin and Sorafenib|Patients will receive i.v. plitidepsin over 1h on days 1, 8 and 15 every 4 weeks (d1, 8, 15 q4wk) and continuous oral sorafenib twice daily (bid) (a cycle is defined as an interval of 4 weeks).
16280564|NCT00788099|Drug|Gemcitabine and Plitidepsin|Patients will receive i.v. gemcitabine over 30 minutes followed 1 hour later by plitidepsin over 1 hour on d1, 8, 15 q4wk (a cycle is defined as an interval of 4 weeks).
16280565|NCT00788073|Drug|STX209|Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks
16280566|NCT00788073|Drug|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
16280567|NCT00788060|Drug|Everolimus (RAD001)|5mg per day, continuously
16280568|NCT00788060|Drug|Sunitinib (Sutent)|37.5 mg per day, 14 days on, 7 day break
16280569|NCT00788047|Drug|Dextromethorphan|Dextromethorphan HCl 30 syrup single dose
16280570|NCT00788047|Drug|Dimebon + Dextromethorphan|Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
16280571|NCT00788034|Drug|Lu AA21004|5 or 10 mg/day
16280572|NCT00788034|Drug|Placebo|Once daily
16280573|NCT00788008|Drug|inhalation anesthesia with isoflurane vs. TIVA with propofol|variable depending upon patient
16280574|NCT00787982|Device|MRI-Guided Laser Induced Thermal Therapy|LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor
16280575|NCT00787969|Biological|rituximab|Give IV
16280576|NCT00787969|Drug|cladribine|Give IV
16280577|NCT00787969|Drug|temsirolimus|Give IV
16280578|NCT00787969|Biological|Filgrastim|Give SC
16280579|NCT00787969|Biological|Pegfilgrastim|
16280580|NCT00787956|Behavioral|Internet Chronic Disease Self-Management Program (ICDSMP)|
16280581|NCT00787943|Drug|Topical benzoyl peroxide 10.0% cream - Formulation 1|Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
16280582|NCT00787943|Drug|Topical benzoyl peroxide 10.0% cream - Formulation 2|Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
16280583|NCT00787930|Drug|Valproic Acid|Tablets, 250mg-3000mg
16280584|NCT00787917|Drug|Omalizumab|Omalizumab subcutaneous injections of 600 mg daily.
16280585|NCT00787917|Drug|Placebo|Placebo subcutaneous injections blinded to match experimental arm dosing regimen.
16280586|NCT00787917|Drug|Itraconazole|Itraconazole twice daily with a maximum daily dose of 400 mg.
16280587|NCT00787891|Drug|rabeprazole|0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
16280588|NCT00787891|Drug|rabeprazole|1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
16280589|NCT00787878|Drug|somatropin|SGA previously treated with Norditropin®
16280590|NCT00787878|Drug|No treatment given|Untreated SGA
16280591|NCT00787878|Drug|No treatment given|AGA (Average gestational age)
16280592|NCT00787852|Drug|Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47|"Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
~Dasatinib is to be taken 1x daily
~50 mg daily 100 mg daily
~70 mg daily 100 mg daily
~100 mg daily 100 mg daily
~Maintenance x 2 years*"
16280593|NCT00787852|Drug|Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib & Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36
~Dasatinib is to be taken 1x daily
~50 mg daily 100 mg daily
~70 mg daily 100 mg daily
~100 mg daily 100 mg daily Maintenance x 2 years*"
16280594|NCT00787839|Other|Glucose challenge test|At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.
16280595|NCT00787839|Other|Glucose tolerance test|Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c.
16280596|NCT00787826|Biological|Live Francisella Tularensis Vaccine|"Approximately 0.0025 mL of vaccine will be administered percutaneously with a bifurcated needle using 15 pricks on the volar surface of the forearm. Vaccination may be repeated up to two times within the year if successful vaccination is not demonstrated by a positive take reaction and a MA titer of ≥ 1:20."
16280597|NCT00787813|Drug|N-Acetyl Cysteine|oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
16280598|NCT00787813|Drug|Placebo|
16280599|NCT00787800|Device|Dual Chamber ICD|Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device.
16280651|NCT00787397|Behavioral|Cognitive Behavioral Therapy-Sleep|Cognitive Behavioral Therapy: 6 sessions of CBT
16280600|NCT00787800|Device|Single Chamber ICD|"Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
~VT/VF detection and therapies with discrimination criteria for single chamber device."
16280601|NCT00787787|Drug|sunitinib malate|Given PO
16280602|NCT00787787|Drug|capecitabine|Given PO
16280603|NCT00787774|Drug|resume raltegravir|resume raltegravir after 16 weeks of stopping
16280604|NCT00787761|Biological|anti-thymocyte globulin|"Anti-Thymocyte Globulin (ATG) is commercially available. The 1st vial contains 25 mg ATG, and the 2nd vial contains > 5 mL SWFI diluent. Ampuls must be refrigerated (2º C - 8º C). Do not freeze.
~Reconstitute 25 mg vial with diluent provided by manufacturer. Roll vial gently to dissolve powder. Use contents of vial within 4 hours. Dilute dosage to a final concentration of 0.5 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection. Gently invert admixture 1-2 times to mix. Use admixture solution immediately.
~Infuse the 1st dose over at least 6 hours, and subsequent doses over at least 4 hours. Infuse through a 0.22 micron in-line filter. Premeds include acetaminophen 650 mg PO, diphenhydramine 25-50 mg PO/IV, and methyprednisolone 1mg/kg at the initiation and half-way through ATG administration."
16280605|NCT00787761|Drug|busulfan|"Commercially available in 60 mg/10 mL ampuls.
~Dilute busulfan injection in 0.9% sodium chloride injection or dextrose 5% in water. The dilution volume should be 10 times the volume of busulfan injection, ensuring that the final concentration of busulfan is ≥ 0.5 mg/mL.
~Store unopened ampuls at 2º C to 8º C. The diluted solution is stable for up to 8 hours at room temperature (25º C) but the infusion must also be completed within that 8-hour time frame. Dilution of busulfan injection in 0.9% sodium chloride is stable for up to 12 hours under refrigeration (2º C to 8º C) but the infusion must also be completed within that 12-hour time frame.
~IV Bu should be administered via a central venous catheter as a 2-hour infusion every 6 hours for 2 consecutive days for a total of 8 doses."
16280606|NCT00787761|Drug|cyclophosphamide|"Cyclophosphamide is commercially available. Cyclophosphamide for injection is available in 2000 mg vials which are reconstituted with 100 ml sterile water for injection.
~The concentration of the reconstituted product is 20 mg/ml. The calculated dose will be diluted further in 250-500 ml of Dextrose 5% in water.
~Reconstituted solutions of lyophilized cyclophosphamide are chemically and physically stable for 24 hours at room temperature or for 6 days in the refrigerator. Specific temperatures are not provided by the manufacturer. Reconstitution of cyclophosphamide with bacteriostatic water containing benzyl alcohol preservative may result in decomposition.
~Each dose will be infused over 1-2 hr (depending on the total volume)."
16280607|NCT00787761|Drug|fludarabine phosphate|"Fludarabine is commercially available as a white, lyophilized powder. Each vial contains 50 mg of fludarabine, 50 mg of mannitol and sodium hydroxide to adjust pH.
~Intact vials should be stored under refrigeration. Reconstituted vials are stable for 16 days and solutions diluted in D5W or NS are stable for 48 hours at room temperature or under refrigeration.
~Fludarabine should be reconstituted with 2 mL of Sterile Water for Injection, USP. Each mL of the resulting solution will contain 25 mg of fludarabine, 25 mg of mannitol, and sodium hydroxide to adjust the pH to 7-8.5. The product should be further diluted for intravenous administration in 5% Dextrose for Injection, USP or in 0.9% Sodium Chloride, USP.
~Fludarabine will be administered as an IV infusion over 30 minutes."
16280608|NCT00787761|Drug|methotrexate|"Commercially available for injection in 2 mL (2.5 mg/mL), 2 mL, 4 mL, 8 mL, 10 mL (25 mg/mL) vials, or 20 mg, 25 mg, 50 mg, or 100 mg vials for reconstitution.
~Vials requiring reconstitution should be reconstituted to a concentration of 25 mg/mL.
~Intact vials should be stored at room temperature and protected from light. Once opened, solutions containing preservatives are stable for 4 weeks at room temperature and up to 3 months refrigerated.
~Administer via slow IV push."
16280609|NCT00787761|Drug|tacrolimus|"Tacrolimus is commercially available as an injection (5 mg/mL; 1 mL ampuls) and as oral capsules (1 mg and 5 mg).
~Tacrolimus injection must be diluted prior to IV infusion with 0.9% sodium chloride or 5% dextrose injection to a concentration of 4-20 μg/mL. Solutions should be prepared in non-PVC plastic or glass. Tacrolimus injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
~Oral therapy should be started as possible as per protocol and 8 to 12 hours after stopping intravenous therapy. Oral doses will be administered twice a day.
~Store tacrolimus capsules and injection at controlled room temperature, 15-30º C (59-86º F)."
16280610|NCT00787761|Procedure|nonmyeloablative allogeneic HSCT|As demonstrated by groups in Houston, Jerusalem & Seattle, RICT has been used to treat hematologic & solid malignancies with related & unrelated donors. Although adequate comparisons of RICT versus ablative alloHCT remain to be reported, the studies of RICT so far suggest that TRM is generally less than would be expected for similar patients undergoing ablative alloHCT; incidence of acute & chronic GVHD is similar or less than ablative alloHCT; autologous hematopoietic recovery is more common than seen following ablative alloHCT if graft failure occurs; powerful GVT effects can be seen but are dependent on high levels of donor T-cell chimerism and RICT are less effective than ablative alloHCT in controlling aggressive malignancies
16280611|NCT00787735|Behavioral|Counseling compliance|Rates of attendance to call counseling session over specific time points
16280612|NCT00787722|Procedure|Hematopoietic Stem Cell Transplantation|Infusion of participant's own stem cells
16280613|NCT00787722|Drug|Cyclophosphamide|A medication used as chemotherapy and to suppress the immune system
16280614|NCT00787722|Drug|G-CSF|A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
16280615|NCT00787722|Drug|rATG|A rabbit polyclonal antibody to lymphocytes
16280616|NCT00787722|Drug|Mesna|A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
16280617|NCT00787722|Drug|Rituximab|Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
16280618|NCT00787722|Drug|Methylprednisolone|A corticosteroid medication used to suppress the immune system and decrease inflammation
16280619|NCT00787709|Behavioral|Pathways|3-year, 30 lesson, School-based universal health promotion curriculum with parent component.
16280620|NCT00787696|Behavioral|Cognitive-behavioral HIV/STD risk reduction|18 60-minute group sessions plus 1 individual health and safety planning session
16280652|NCT00787384|Drug|Imatinib|Patients received oral imatinib 100 mg/d; in case of unsatisfactory response (less than complete) Imatinib could be increased by 100 mg/die on a weekly basis and up to a maximum of 400 mg/die. Imatinib wsa discontinued after 12 total weeks of therapy.
16280621|NCT00787683|Device|Home-monitoring provided by LUMAX ICD device and CardioMessenger II|All study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up.
16280622|NCT00787670|Other|Diabetes Support and Education|The subjects will attend three educational/social support sessions for 1 year after enrollment. The educational sessions include informational sessions on diet/nutrition and exercise. These sessions are informational and do not teach behavioral self-regulation skills.
16280623|NCT00787670|Procedure|gastric bypass surgery|gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
16280624|NCT00787670|Other|Tissue Control Group|During the abdominal surgery we would like to take 5 ml blood from the IV line and small pea-sized samples of the fat tissue just under the skin and around the stomach area. These samples will be stored so that we can compare these tissue with other patients.
16280625|NCT00787657|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis
16280626|NCT00787644|Drug|Pioglitazone|Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
16280627|NCT00787644|Drug|Placebo|Matching placebo (inert tablet)
16280628|NCT00787618|Drug|50 mg Proellex|Single dose
16280629|NCT00787605|Drug|Amlodipine|Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks
16280630|NCT00787605|Drug|Hydrochlorothiazide (HCTZ)|Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks
16280631|NCT00787605|Drug|Aliskiren|Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks
16280632|NCT00787579|Device|Bifocal spectacles|+1.50D bifocal spectacles
16280633|NCT00787579|Device|Prismatic bifocal spectacles|+1.50D bifocal spectacles combined with 3Δ base-in prisms
16280634|NCT00787566|Drug|Intranasal granisetron|0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
16280635|NCT00787553|Drug|cefazolin|2.0 g, IV, 2 hours before surgery
16280636|NCT00787553|Drug|tinidazole|2.0 g orally, 12 hours before surgery
16280637|NCT00787553|Drug|cefazolin plus tinidazole|cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery
16280638|NCT00787527|Drug|Zolinza (vorinostat)|Up to two 100 mg capsules of Vorinostat (dosage will vary from 100 mg orally (PO) twice daily (BID), 300 mg PO every evening and 200 mg PO BID with the starting dose at 300 mg PO every evening for the phase I trial) are to be administered orally twice daily (once in the morning and once in the evening, or if in the daily dosing cohort once in the evening) in repeated 21-day cycles consisting of 10 days dosing starting on days 5 through 14 followed by a 7-day rest period, during which no vorinostat will be administered.
16280639|NCT00787527|Drug|Cyclophosphamide|750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle
16280640|NCT00787527|Drug|Doxorubicin|50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
16280641|NCT00787527|Drug|Vincristine|1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle
16280642|NCT00787527|Drug|Prednisone|100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle
16280643|NCT00787501|Drug|SSRI|SSRI: 25 patients will receive 14 weeks of an FDA approved selective serotonin reuptake inhibitor (SSRI), administered under the supervision of a staff psychiatrist. After an initial 30-45 minute session patients will be seen for 15-30 minute sessions for 16-20 sessions over 14 weeks. Medication will begin with 10mg escitalopram daily (or its equivalent), increased to 30 mg/day (or its equivalent) by week 6 if pt has not achieved a minimum level of response (i.e., CGI < 2) and tolerability is adequate. Nonresponse at week 10 (CGI < 2) will be cause for medication switch or augmentation.
16280644|NCT00787501|Behavioral|CBT|Cognitive Behavior Therapy: 40 patients will receive 16- 20 60 minute sessions of procedurally determined Cognitive Therapy (Beck, 1979) over 14 weeks. Patients will begin with 2 sessions per week which may be reduced to once per week in the latter part of the study period if the patient is responding to the therapy. Cognitive Therapy is designed to teach skills that help to reduce depressive severity. Each session will be videotaped and will include homework to be completed and brought to the following session.
16280645|NCT00787488|Device|Hyperthermia|Every 3 weeks
16280646|NCT00787475|Other|Community Health worker|Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
16280647|NCT00787462|Drug|Pregabalin|Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
16280648|NCT00787462|Drug|Placebo|Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
16280649|NCT00787436|Drug|Thalidomide|Medical therapy has been used to decrease upper gastrointestinal bleeding in cirrhotics Non Selective beta blockers have been shown to effectively decrease the portal venous pressure
16280650|NCT00787410|Drug|ZD1839|250mg tablet, once daily, orally administered
16280653|NCT00787371|Biological|PegIntron (peginterferon alfa-2b)|PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
16280654|NCT00787371|Biological|PegIntron (peginterferon alfa-2b)|PegIntron 0.5 mcg/kg SC QW for 12 weeks
16280655|NCT00787371|Biological|PegIntron (peginterferon alfa-2b)|PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
16280656|NCT00787358|Drug|ZT-031|80 ul subcutaneous injection per day
16280657|NCT00787358|Other|placebo|80 ul daily subcutaneous injection of vehicle only
16280658|NCT00787345|Other|simulation based training|simulation based training in aseptic techniques that included specified AT categories
16280659|NCT00787332|Drug|Desirudin or Argatroban®|Desirudin 15mg SC Argatroban® IV dosing per Package Insert
16280660|NCT00787319|Other|no intervention|Outpatients with age-related macular degeneration (AMD)
16280661|NCT00787306|Behavioral|Active risk factor surveillance|Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
16280662|NCT00787293|Device|PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant|Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
16280663|NCT00787280|Behavioral|Low Carbohydrate Ketogenic Diet (LCKD)|participants will follow a low carbohydrate ketogenic diet for six weeks
16280664|NCT00787280|Behavioral|Low Fat Diet (LFD)|particpants will follow a low fat diet for six weeks
16280665|NCT00787267|Drug|Dasatinib|70 mg PO twice daily until progression. Re-assess radiographically every 6 weeks.
16280666|NCT00787254|Drug|Lansoprazole|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
16280667|NCT00787254|Drug|Gefarnate|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
16280668|NCT00787215|Other|observational: no treatment involved|observational: no treatment involved
16280669|NCT00787202|Drug|CP- 690 550|Administration via oral route twice daily for the duration of treatment
16280670|NCT00787202|Drug|CP- 690 550|Administration via oral route twice daily for the duration of treatment
16280671|NCT00787202|Drug|CP- 690 550|Administration via oral route twice daily for the duration of treatment
16280672|NCT00787202|Drug|CP- 690 550|Administration via oral route twice daily for the duration of treatment
16280673|NCT00787202|Other|placebo|Administration via oral route twice daily for the duration of treatment
16280674|NCT00787189|Device|The Hearing Laser|Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
16280675|NCT00787189|Device|Placebo Laser|inactive low level laser light therapy with no therapeutic output
16280676|NCT00787176|Procedure|Lactated Ringers bolus of 1000 ml|Lactated Ringers bolus of 1000 ml initiated at patient positioning for epidural placement
16280677|NCT00787176|Procedure|No additional fluid|Regular maintenance infusion of Lactated Ringers @ 125 ml/hr; no additional fluids
16280678|NCT00787176|Procedure|Routine oxytocin|per regular oxytocin protocols
16280679|NCT00787176|Procedure|Half-dose oxytocin|The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes after initiation of labor analgesia
16280680|NCT00787163|Procedure|amnioinfusion|serial amnioinfusions aimed at restoring amniotic fluid volume
16280681|NCT00787150|Drug|Apixaban|Apixaban 5 mg tablet BID for 12 weeks
16280682|NCT00787150|Drug|Apixaban|Apixaban 2.5 mg tablet BID for 12 weeks
16280683|NCT00787150|Drug|Warfarin sodium|At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks
16280684|NCT00787137|Drug|PG102|A single intravenous infusion
16280685|NCT00787137|Drug|Placebo comparator|Phosphate-buffered saline
16280686|NCT00787111|Drug|Fluoxetine (prozac)|Formulation: ODT
16280687|NCT00787098|Other|ETM protocol|ETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning.
16280688|NCT00787072|Drug|AZD8075|Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
16280689|NCT00787072|Drug|Placebo|Oral suspension
16280690|NCT00787059|Drug|Ad5.hAC6|Intracoronary delivery of test substance in 3:1 randomization (Ad5.hAC6 : placebo) with dose escalation, starting at 3.2 x 10^9 vp to 10^12 vp in 5 dose groups
16280691|NCT00787059|Drug|Sucrose (3%)|
16280692|NCT00787033|Drug|PF-04554878|Oral pills at increasing dose twice daily, 21 day cycle, continuous treatment schedule until progression of disease, unacceptable toxicity, or patient request. Some patients will undergo serial biopsy and/or FDG-PET imaging
16280693|NCT00787007|Drug|S-equol|capsule, oral, single dose
16280694|NCT00787007|Drug|Placebo|capsule, oral, single dose
16280695|NCT00786994|Drug|Oleogel-S10 100 mg/g|topical use once or twice daily
16280696|NCT00786994|Drug|Placebo (petroleum jelly)|topical use once or twice daily
16280697|NCT00786981|Other|Epidural steroid injection plus physical therapy|Patients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book.
16280698|NCT00786981|Other|Epidural steroid injection|Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
16280699|NCT00786968|Drug|laronidase|1.74 mg intrathecally every 1-3 months for 1 year
16280700|NCT00786942|Procedure|high tibial osteotomy|addition of bone graft to fill the osteotomy gap
16280701|NCT00786942|Procedure|higi tibial osteotomy|the gap of the tibia is unfilled
16280702|NCT00786929|Procedure|Catheter drainage|
16280703|NCT00786929|Drug|Conservative treatment|
16280704|NCT00786916|Drug|normal saline|A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
16280705|NCT00786916|Drug|lidocaine|A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
16280706|NCT00786916|Drug|lidocaine|A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
16280707|NCT00786890|Other|observational, no intervention needed|observational, no intervention needed
16280708|NCT00786877|Other|Improved biomass cookstove with exterior ventilation|Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.
16280709|NCT00786877|Other|Phase 2 intervention arm (LPG stove)|LPG two burner stove with a 12 month supply of LP gas.
16280710|NCT00786864|Other|exercise programme|Specific low back pain exercise programme for children
16280711|NCT00786851|Drug|Lenalidomide and Dexametasone|Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).
16280712|NCT00786838|Drug|Trabectedin|Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2.
16280713|NCT00786838|Drug|Placebo|Participants will receive 3-hour placebo intravenous infusion on Day 1.
16280714|NCT00786825|Drug|somatostatin|Somatostatin may be used to suppress endogenous insulin secretion
16280715|NCT00786812|Drug|Nilotinib|
16280716|NCT00786799|Dietary Supplement|Omega-3 Fatty Acids|"Omega-3's are administered in the form of an orange pudding made by Coromega
~1 mg of omega-3 fatty acid 2 times per day"
16280717|NCT00786799|Dietary Supplement|Omega-3 Fatty Acids|"Omega-3 Fatty Acids in orange pudding form
~1 packet two times per day"
16280718|NCT00786760|Other|Cohort: 3000 men examined every 6 months for 4 years.|Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
16280719|NCT00786760|Other|Pilot study: 150 men examined every 6 months for 4 years.|Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
16280720|NCT00786747|Behavioral|Personally tailored computer program|The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish).
16280721|NCT00786747|Behavioral|Non-tailored control computer program|This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).
16280722|NCT00786734|Drug|Pitavastatin|4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
16280723|NCT00786734|Drug|Pitavastatin|4mg daily for 28 days after PCI
16280724|NCT00786721|Device|Diffuse Optical Spectroscopy|muscle properties scanning
16280725|NCT00786695|Drug|esomeprazole|esomeprazole (40 mg o d) for 14 days
16280726|NCT00786695|Drug|Placebo|Identical looking Placebo, same regimen, for 14 days
16280727|NCT00786682|Drug|docetaxel|
16280728|NCT00786682|Drug|hydroxychloroquine|
16280729|NCT00786669|Drug|Bevacizumab|Bevacizumab (IV) 15 mg/Kg on day 1 every 3 weeks for up to 6 cycles
16280730|NCT00786669|Drug|Temozolomide|100 mg/m2/day po on Days 1-5 every 3 weeks for up to 6 cycles. For patients under 0.5 m2 BSA, TEM = 3.3 mg/kg/day po on Days 1-5.
16280731|NCT00786669|Drug|Vincristine|1.5 mg/m2 on Day 1 (max dose 2 mg) administered as an IV bolus every 3 weeks for up to 6 cycles. For patients <0.5 m2 BSA, VCR dose = 0.05 mg/kg (maximum dose 2 mg).
16280732|NCT00786669|Drug|Irinotecan|90 mg/m2/day po on Days 1-5 every 3 weeks for up to 6 cycles
16280733|NCT00786669|Drug|Cefixime|8 mg/kg/day (max. daily dose 400 mg) of cefixime or 5 mg/kg/dose bid (max. daily dose 400 mg) of cefpodoxime starting Day -1 BEFORE chemotherapy and continuing EVERY DAY while on study, or for 2 days after last dose of chemotherapy if treatment stopped early for disease progression or toxicity
16280734|NCT00786643|Drug|5-Fluorouracil|5-FU bolus was administered at 400mg/m^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle.
16280735|NCT00786643|Drug|Leucovorin (LV)|Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
16280736|NCT00786643|Drug|Gamma-Interferon-1b (IFN-γ)|Gamma-Interferon 150 mcg/m^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV.
16280737|NCT00786643|Drug|Bevacizumab|Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.
16280738|NCT00786630|Behavioral|Strengths-based case management|Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline.
16280779|NCT00786266|Behavioral|NIOSH shiftwork booklet|weekly readings about coping with shiftwork
16280739|NCT00786630|Behavioral|Case management plus facilitated treatment alliance|Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline. They will also receive a facilitated treatment alliance, which consists of meetings with methadone counselors to aid in treatment entry.
16280740|NCT00786565|Device|Advanced Akreos Adapt in one operated eye.|Cataract surgery to implant the assigned IOL according to randomized schedule.
16280741|NCT00786565|Device|Akreos Adapt in fellow operated eye.|Cataract surgery to implant the assigned IOL according to randomized schedule.
16280742|NCT00786552|Drug|pemetrexed + paclitaxel|Pemetrexed 500 mg/m² i.v. over 10 minutes on day 8 Paclitaxel 90 mg/m² i.v. over 60 minutes on day1 and 8
16280743|NCT00786539|Device|Diffuse Optical Spectroscopy|mitochondria
16280744|NCT00786513|Other|Conventional antimicrobial susceptibility testing|Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on conventional planktonic antimicrobial susceptibility testing results.
16280745|NCT00786513|Other|Biofilm antimicrobial susceptibility testing|Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on biofilm antimicrobial susceptibility testing results.
16280746|NCT00786500|Dietary Supplement|Gynostemma pentaphyllum tea|3 grams twice daily, orally
16280747|NCT00786500|Dietary Supplement|Placebo tea|3 grams twice daily, orally
16280748|NCT00786487|Drug|20% lipid infusion|1.5 ml/min for 6 hours
16280749|NCT00786487|Drug|glycerol|glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
16280750|NCT00786474|Drug|Placebo|Normal saline solution, dosage determined by weight, self-administered by patient twice a day
16280751|NCT00786474|Drug|Dalteparin|Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
16280752|NCT00786461|Procedure|silver nitrate application to the Bartholin´s cyst|5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.
16280753|NCT00786461|Procedure|silver nitrat stick|The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.
16280754|NCT00786448|Drug|Darifenacin, Emselex (BAY79-4998)|Patients from routine practice
16280755|NCT00786422|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
16280756|NCT00786409|Biological|Gardasil|0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
16280757|NCT00786396|Behavioral|Directly administered antiretroviral therapy|Daily observation of subjects taking their HIV medications
16280758|NCT00786383|Biological|IMC-1121B|"Cohort 1
~6 mg/kg I.V., once every other week for 4 weeks"
16280759|NCT00786383|Biological|1121B|"Cohort 2
~8mg/kg I.V., once every other week for 4 weeks"
16280760|NCT00786383|Biological|1121B|"Cohort 3
~10 mg/kg I.V., once every other week for 4 weeks"
16280761|NCT00786383|Biological|1121B|"Cohort 4
~15 mg/kg I.V., once every 3 weeks for 6 weeks"
16280762|NCT00786383|Biological|1121B|"Cohort 5
~20 mg/kg I.V., once every 3 weeks for 6 weeks"
16280763|NCT00786370|Drug|dexmedetomidine|Propofol or dexmedetomidine infusion will be started according to the randomized treatment allocation. The propofol group will receive a bolus of 2mg midazolam and 100mcg fentanyl and then continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved. The dexmedetomidine group will receive a bolus of dexmedetomidine 1mcg/kg for 10 minutes and then a continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
16280764|NCT00786370|Drug|Propofol|continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
16280765|NCT00786370|Drug|Dexemedetomidine|continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
16280766|NCT00786357|Behavioral|NIOSH shiftwork booklet|weekly readings about coping with shiftwork
16280767|NCT00786357|Behavioral|Sleep Enhancement Training System|4 week program of readings and relaxation programs
16280768|NCT00786344|Behavioral|Lifestyle Redesign|"For a six-month period, each elder participated in weekly 2-hour sessions involving groups of size 8-10, and also received up to 10 hours of individualized treatment over this time period.
~Modular treatment units included the following content areas: (1) Introduction to the Power of Activity; (2) Aging, Health, and Activity; (3) Transportation; (4) Safety; (5) Social Relationships; (6) Cultural Awareness; (7) Finances; and (8) Integrative Summary: Lifestyle Redesign Notebook. The methods of program delivery consisted of didactic presentation, peer exchange, direct experience, and personal exploration. Treatment materials were translated into Spanish and culturally adapted for approximately 15% of the subjects."
16280769|NCT00786331|Drug|Pemetrexed|Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
16280770|NCT00786331|Drug|Pemetrexed plus carboplatin|Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle
16280771|NCT00786318|Drug|ziprasidone|ziprasidone 20mg IM
16280772|NCT00786318|Drug|Standard therapy|Haldol 5mg/ Ativan 2mg IM
16280773|NCT00786305|Drug|ceftazidime and amikacin|Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days
16280774|NCT00786305|Drug|ceftazidime and amikacin|Intravenous infusion of ceftazidime 30 mg/kg over 30 min followed by continuous infusion 90 mg/kg/day during 8 days and intravenous infusion of amikacin 15 mg/kg/day over 30 min during 3 days
16280775|NCT00786292|Other|Assisted mechanical ventilation|Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
16280776|NCT00786279|Other|ethanol|15 gm ethanol daily for 6 months
16280777|NCT00786279|Other|Ethanol-free beverage|0 grams ethanol daily for 6 months.
16280778|NCT00786266|Behavioral|Sleep Enhancement Training System|4 week program of readings and relaxation programs
16280780|NCT00786253|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10 mg on demand use
16280781|NCT00786253|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil daily dosing 10 mg
16280782|NCT00786240|Drug|Fesoterodine|Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
16280783|NCT00786240|Drug|Fesoterodine|Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)
16280784|NCT00786214|Other|Acupuncture|Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists
16280785|NCT00786214|Other|Sham acupuncture|Patients will be given sham acupuncture treatment at dummy acupuncture points
16280786|NCT00786201|Drug|Placebo|Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48
16280787|NCT00786201|Drug|CNTO 888 1 mg/kg|IV infusion every 4 weeks, from Week 0 through Week 48
16280788|NCT00786201|Drug|CNTO 888 5 mg/kg|IV infusion every 4 weeks, from Week 0 through Week 48
16280789|NCT00786201|Drug|CNTO 888 15 mg/kg|IV infusion every 4 weeks, from Week 0 through Week 48
16280790|NCT00786188|Drug|Brisdelle (paroxetine mesylate)|Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.
16280791|NCT00786188|Drug|Sugar pill|Subjects will receive a sugar pill.
16280792|NCT00786162|Other|Internet-enabled automated self-management program|An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.
16280793|NCT00786162|Other|BP cuff at workplace|Provided BP cuff for communal use at the worksite
16280794|NCT00786149|Other|Varenicline plus Motivational Interviewing counseling|Motivational Interviewing; 8 weeks of counseling
16280795|NCT00786149|Other|Varenicline without counseling|Brief advice, one time during initial session
16280796|NCT00786136|Drug|rosuvastatin|rosuvastatin
16280797|NCT00786123|Dietary Supplement|VSL#3|Dose: 4 capsules of VSL#3 daily for 6 weeks.
16280798|NCT00786123|Dietary Supplement|Placebo|Identical looking preparation of placebo taken at the same dose regimen as the active comparator
16280799|NCT00786110|Drug|Sorafenib|Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid until disease progression.
16280800|NCT00786110|Drug|Paclitaxel|Intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.
16280801|NCT00786097|Drug|Dermacyd PH_DETINLYN (Lactic Acid)|
16280802|NCT00786058|Drug|OFF in experimental arm|OFF was given according to a six week cycle. FA (500 mg/m2 , 0.5h, i.v.) and 5-FU (2,600 mg/m2, 24-hour, i.v.) were administered on days 1, 8, 15, and 22. Oxaliplatin (85 mg/m2 , 2-4 h, i.v.) was administered directly before FA/ 5-FU on days 8 and 22.
16280803|NCT00786045|Other|Home Cycling Program|Participants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate.
16280804|NCT00786032|Device|BCI Device|A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.
16280805|NCT00786019|Behavioral|Exercise program|Three month exercise program located at the Anschutz Medical Campus at I-225 and Colfax. The program runs three times per week for about an hour each session. Gym is open Monday - Saturday during specific hours (morning, noon, evening).
16280806|NCT00786019|Drug|Ascorbic Acid (Vitamin C)|"During one exercise study visit, 0.06 grams of Vitamin C per kilogram fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a drip-infusion given at 1.7ml/minute."
16280807|NCT00786006|Drug|FOLFIRI.3|FOLFIRI.3: Irinotecan 70 mg/m2 (over 60 min) on D1, LV 400 mg/m2 (over 2h) D1, 5-FU 2000 mg/m2 (over 46 hours) from D1, then irinotecan 70 mg/m2(over 60 min) at the end of the 5-FU infusion
16280808|NCT00786006|Drug|FOLFOX|FOLFOX: oxaliplatin 85 mg/m2 (over 120 min) on D1, LV 400 mg/m2 (over 2hour) on D1, 5-FU 400 mg/m2 IVP on D1, 5-FU 2,000 mg/m2 (over 46 hours)
16280809|NCT00785993|Other|Vitrification of oocytes for IVF treatment|
16280810|NCT00785993|Other|Protocolary IVF treatment with fresh donor oocytes|
16280811|NCT00785980|Drug|Quinine Sulfate Capsules 324 mg|A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours.
16280812|NCT00785980|Drug|Ciprofloxacin 500 mg|A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
16280813|NCT00785980|Drug|Quinine Sulfate Capsules 324 mg|A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
16280814|NCT00785967|Biological|Various vaccines|VAQTA: 1.0ml IM at weeks 24 & 48; Pneumovax 23: 0.5ml IM at screening; Td ADSORBED: 0.5ml IM at screening; phiX174 bacteriophage: 0.02ml/kg body weight IV at weeks 28, 32, 36, 40.
16280815|NCT00785954|Drug|KAI-9803|STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
16280816|NCT00785941|Biological|IMC-A12|"Cohort 1
~6 mg/kg I.V., once every other week for 4 weeks"
16280817|NCT00785941|Biological|IMC-A12|"Cohort 2
~10 mg/kg I.V., once every other week for 4 weeks"
16280818|NCT00785941|Biological|IMC-A12|"Cohort 3
~15 mg/kg I.V., once every other week for 4 weeks"
16280819|NCT00785941|Biological|IMC-A12|"Cohort 4
~21 mg/kg I.V., once every other week for 4 weeks"
16280820|NCT00785941|Biological|IMC-A12|"Cohort 5
~27 mg/kg I.V., once every other week for 4 weeks"
16280821|NCT00785928|Biological|LY2127399|Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
16280822|NCT00785928|Drug|Placebo|Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
16280823|NCT00785915|Drug|AZD6765|single administration and once daily for 5 days
16281753|NCT00778700|Drug|Ruxolitinib Phosphate Cream|0.5% phosphate cream
16280824|NCT00785915|Drug|Placebo|single administration and once daily for 5 days
16280825|NCT00785902|Device|AtriCure Bipolar System|
16280826|NCT00785889|Procedure|water infusion colonoscopy|water infusion in lieu of air insufflation for screening colonoscopy
16280827|NCT00785876|Other|LRAR Implementation|"Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up.
~Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals."
16280828|NCT00785863|Other|Placebo|Placebo IV before placebo infusion
16280829|NCT00785863|Drug|Remifentanil|placebo IV and remifentanil infusion
16280830|NCT00785863|Drug|Ketorolac and remifentanil|Ketorolac IV and remifentanil infusion
16280831|NCT00785863|Drug|Parecoxib and remifentanil|Parecoxib IV and remifentanil infusion
16280832|NCT00785850|Drug|Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower|
16280833|NCT00785837|Other|Aquatic Physical Therapy|The Physiotherapy was performed with gentle movements in eight shape, from left to right, in addition to movements of unbundling girdle, light and slow the trunk and extremities posture and body by flexing the organization Wrapping the body.
16280834|NCT00785811|Drug|L-arginine aspartate (Targifor)|3g of L-arginine taken orally in a single daily dose for 8 weeks
16280835|NCT00785811|Drug|Placebo L-arginine aspartate (Targifor)|Placebo of L-arginine taken orally in a single daily dose for 8 weeks
16280836|NCT00785798|Drug|Vorinostat|200mg to 400 mg twice daily on days 1-7
16280837|NCT00785798|Drug|Pegylated Liposomal Doxorubicin (PLD), Doxil|IV 30mg/m2 on day 3 of a 21-day cycle
16280838|NCT00785785|Drug|Nilotinib (AMN107)|
16280839|NCT00785785|Drug|imatinib (STI571)|
16280840|NCT00785772|Drug|Gabapentin|100-200mg once a day
16280841|NCT00785772|Drug|Gabapentin|200-500mg once a day
16280842|NCT00785772|Drug|Gabapentin|400-1000mg (200-500 mg twice a day)
16280843|NCT00785759|Drug|AH110690 (18F) Injection|All subjects will receive an I.V. dose of [18F]AH110690 (less than 10 mg of total AH110690). The target activity of a single administration of [18F]AH110690 will be 185 MBq (equivalent to a dose of approximately 6 mSv).
16280844|NCT00785746|Other|Core|We have devised a series of core strength training exercises that can be easily and safely performed under the supervision of trained staff. The exercises will be individualized depending on the participants' ability and health conditions. The majority, but not all, of exercises will be performed on or with exercise balls of different sizes and shapes, round for more advanced persons and oval for more frail persons.
16280845|NCT00785720|Drug|Dermacyd PH_DETINBACK (Lactic Acid)|
16280846|NCT00785694|Drug|hexaminolevulinate|Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
16280847|NCT00785681|Drug|Dermacyd PH_DETINBACK (Lactic Acid)|
16280848|NCT00785668|Drug|AER 001|10 mg dry powder administered using a handheld device
16280849|NCT00785655|Drug|Dermacyd PH_DETINLYN (Lactic Acid)|
16280850|NCT00785642|Drug|Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)|
16280851|NCT00785629|Drug|Calcium acetate|
16280852|NCT00785629|Drug|Lanthanum Carbonate|
16280853|NCT00785629|Drug|Sevelamer Carbonate|
16280854|NCT00785629|Drug|Placebo|
16280855|NCT00785616|Other|MEMS cap monitoring|Electronic monitoring of medication adherence using MEMS caps
16280856|NCT00785616|Other|MEMS cap monitoring|Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time signature of each bottle opening.
16280857|NCT00785616|Other|MEMS cap monitoring|Adherence to antiretroviral medications will be measured using electronic bottle caps (MEMS caps) that record the time/date signature of each bottle opening.
16280858|NCT00785603|Drug|Paroxetine|tablets of 20 mg paroxetine
16280859|NCT00785603|Drug|Paroxetin placebo|capsules with lactulose to hide, whether the volunteer are receiving 0, 10, 20, 30 or 50 mg paroxetine
16280860|NCT00785603|Drug|Tramadol|Capsules of 50 mg tramadol
16280861|NCT00785590|Drug|Dermacyd PH_DETINLYN (Lactic Acid)|
16280862|NCT00785577|Drug|Placebo|"LY545694 placebo BID po for 5 weeks
~Pregabalin placebo capsules TID po for 6 weeks"
16280863|NCT00785577|Drug|Pregabalin|"Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
~LY545694 placebo BID po for 5 weeks"
16280864|NCT00785577|Drug|LY545694 21 mg|"LY545694 21 mg BID po for 1 week
~Pregabalin placebo TID po for 6 weeks"
16280865|NCT00785577|Drug|LY545694 49 mg|"LY545694 escalated to 49 mg BID po for 1 week during Week 2.
~Pregabalin placebo TID po for 6 weeks."
16280866|NCT00785577|Drug|LY545694 105 mg|"LY545694 105 mg BID po for 5 weeks
~Pregabalin placebo TID po for 6 weeks"
16280867|NCT00785551|Drug|quinine sulfate|2 x 324mg given in one dose to healthy subjects
16280868|NCT00785551|Drug|quinine sulfate|2 x 324mg given as one dose to subjects with mild renal impairment
16280869|NCT00785551|Drug|quinine sulfate|2 x 324mg given as one dose to subjects with moderate renal impairment
16280870|NCT00785538|Biological|IMC-A12|"Cohort 1
~3 milligrams/kilogram (mg/kg), I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280871|NCT00785538|Biological|IMC-A12|"Cohort 2
~6 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280872|NCT00785538|Biological|IMC-A12|"Cohort 3
~10 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280873|NCT00785538|Biological|IMC-A12|"Cohort 4
~15 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280874|NCT00785538|Biological|IMC-A12|"Cohort 5
~21 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280875|NCT00785538|Biological|IMC-A12|"Cohort 6
~27 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period."
16280876|NCT00785525|Drug|Filgrastim|PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.
16280877|NCT00785512|Drug|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
16280878|NCT00785512|Drug|Placebo|Matching placebo tablets, oral administration
16280879|NCT00785499|Behavioral|Milk Components and Metabolic syndrome|1 liter per day of the test drinks for 3 mo
16280880|NCT00785486|Drug|Midazolam Alone|Midazolam 2 mg syrup was given orally after a fast of at least 10 hours.
16280881|NCT00785486|Drug|Qualaquin (quinine) alone steady state|Qualaquin (quinine) 324 mg capsules were given orally every 8 hours for 7 days ( 21 doses total). On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen and fasting for at least 10 hours, all participants took their usual dose of Qualaquin (quinine). Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine at steady state
16280882|NCT00785486|Drug|Midazolam and Qualaquin at steady state|On the morning of day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen (324 mg every 8 hours), all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg after a fast of at least 10 hours
16280883|NCT00785473|Dietary Supplement|cholecalciferol|cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
16280884|NCT00785473|Dietary Supplement|calcium carbonate|calcium carbonate 500 mg daily for 2 years
16280885|NCT00785460|Drug|Benfotiamine|
16280886|NCT00785447|Other|Mouth-to-mouth or mouth-to-nose breathing|Patients undergoing elective surgery under general anesthesia will be given mouth-to-mouth and mouth-to-nose breaths. The respiration process will be measured and recorded by the help of elastic bands put around the chest and abdomen. The efficiency of the breathing methods will be evaluated.
16280887|NCT00785434|Drug|escitalopram|Dose ranging up to 50mg
16280888|NCT00785421|Drug|enoxaparin|Patients receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS < 80 % and increased creatinin plasma levels (>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- LMWM +/- Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- Enoxaparin 40mg/d s.c.
16280889|NCT00785421|Drug|chemotherapy with LMWH - enoxaparin|1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.
16280890|NCT00785421|Drug|only chemotherapy|observation, no treatment with LMWH
16280891|NCT00785408|Drug|AC2307|subcutaneous, twice daily, low dose
16280892|NCT00785408|Drug|placebo|subcutaneous, twice daily, low dose
16280893|NCT00785408|Drug|AC2307|subcutaneous, twice daily, middle dose
16280894|NCT00785408|Drug|placebo|subcutaneous, twice daily, middle dose
16280895|NCT00785408|Drug|AC2307|subcutaneous, twice daily, high dose
16280896|NCT00785408|Drug|placebo|subcutaneous, twice daily, high dose
16280897|NCT00785395|Drug|Oxytocin infusion|Up-down dosing determination
16280898|NCT00785382|Drug|Placebo|Lactulose Placebo
16280899|NCT00785382|Drug|Pregabalin 150 mg|150 mg Q12H x 2 doses
16280900|NCT00785369|Device|Reflectance confocal microscopy|Reflectance confocal microscopy (VivaScope 1500)
16280901|NCT00785356|Drug|Proellex 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
16280902|NCT00785356|Drug|Proellex 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
16280903|NCT00785356|Drug|Placebo|Placebo, 2 capsules daily for 3 months
16280904|NCT00785343|Device|Reo Go robotic arm trainer|Robotic training with the Reo Go is included with conventional treatment during daily OT sessions
16280905|NCT00785343|Procedure|Conventional Therapy|Occupational therapy that is the current standard of care
16280906|NCT00785330|Drug|standard GVHD prophylaxis|Application of tacrolimus from day -1 with a goal of tacrolimus serum concentration of 10 ng / ml Aplication of mycophenolat mofetil from day +1 to day +28 in a dose of 2 x 1g per day
16280907|NCT00785330|Drug|rituximab|Patients receiving 375 mg/ m2 of rituximab at weeks 3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation in addition to standard GVHD prophylaxis (tacrolimus with aimed serum level of 10 ng / ml and mycophenolat mofetil 2 x 1 g p.o. day 1 to 28 after allogeneic SZT
16280908|NCT00785317|Drug|Angemin vs Activelle|1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
16280915|NCT00785265|Behavioral|Group-Based (GB) Intervention|60-minute group session involving other study patients who have been assigned to this condition and their guests.
16280916|NCT00785265|Behavioral|Home-Based (HB) Intervention|60-minute educational intervention in their home, which will be delivered by an African American health educator.
16280917|NCT00785252|Device|Powered Intraosseous device (EZIO)|EZIO
16280918|NCT00785252|Device|standard central line|placement of a central line
16280919|NCT00785226|Drug|RDEA119|Total daily doses of RDEA119 from 10 mg/day to 100 mg/day
16280920|NCT00785226|Drug|Sorafenib|Total daily doses of sorafenib from 400 mg/day to 800 mg/day.
16280921|NCT00785213|Drug|Rosiglitazone 4 mg Tablets|Rosiglitazone 4 mg tablet administered as a single oral dose on the morning of Day 1.
16280922|NCT00785213|Drug|Rosiglitazone 4 mg Tablets|Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.
16280923|NCT00785213|Drug|Quinine Sulfate 324 mg Capsules|Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7.
16280924|NCT00785200|Other|Chlorhexidine|Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.
16280925|NCT00785200|Other|Water|Water-soaked disposable wash cloths identical in appearance to the CHG cloths will be distributed to enrolled detainees on every Monday, Wednesday, and Friday for a 6-month period.
16280926|NCT00785187|Device|exposure to UVB radiation|exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
16281433|NCT00781430|Drug|Neratinib (HKI-272)|Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)
16280927|NCT00785174|Device|continuous positive airway pressure|respiratory assistance using face mask and positive expiratory pressure apllied by a Boussignac valve
16280928|NCT00785174|Device|noninvasive pressure support ventilation|noninvasive pressure support ventilation can provide inspiratory pressure support and expiratory positive pressure
16280929|NCT00785174|Device|noninvasive pressure support ventilation|noninvasive pressure support ventilation provides an inspiratory aid and positive expiratory pressure using ventilator through face mask
16280930|NCT00785161|Device|Penumbra System|Mechanical Thrombectomy in acute stroke
16280931|NCT00785148|Drug|Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)|
16280932|NCT00785135|Device|Lenses containing prismatic correction|The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.
16280933|NCT00785135|Device|Lenses not containing prismatic correction|The patient will receive lenses containing correction for hyperopia, myopia and astigmatism as indicated during initial examination. The patient will not receive prismatic correction in these lenses.
16280934|NCT00785122|Drug|Endoxana, Leukine, IMA910|a single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90
16280935|NCT00785122|Drug|Endoxana, Leukine, IMA910, Aldara|a single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90 followed by Aldara (Imiquimod)
16280936|NCT00785109|Dietary Supplement|Vitamin K supplementation|Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
16280937|NCT00785096|Other|Questionnaire|Questionnaire, complications, grading severity, visual analog scale
16280938|NCT00785083|Drug|FTY720|
16280939|NCT00785083|Drug|Placebo|
16280940|NCT00785044|Drug|I-123 mIBG|This was an observational study. Participants were previously dosed in separate study.
16280941|NCT00785031|Other|internet based vascular risk factor intervention|The patient and a nurse practitioner create an internet dossier and the patient is instructed on how to use the internet dossier. The internet dossier is mainly meant for the patient: to improve knowledge of vascular risk factors, to give an overview of the actual status of the levels of his/her vascular risk factors and to give guidance and personal advice how to treat risk factors with medication and/or lifestyle.
16280942|NCT00785018|Drug|C1-esterase inhibitor|C1-esterase inhibitor 100 U/kg infusion over 30 minutes.
16280943|NCT00785018|Drug|Endotoxin administration|2 ng/kg E. coli reference endotoxin 11:H 10:K negative intravenously
16280944|NCT00784992|Procedure|Endonasal dacryocystorhinostomy|"The standard dacryocystorhinostomy operation performed in this centre uses silicone tubes to stent open the newly created ostium between the lacrimal sac and the nasal cavity. However many surgeons in other departments / countries around the world perform the surgery without tubes. No large well-conducted RCT has been published comparing success rates / complication rates for the two techniques. For this study the control group is the arm which receives tubes (our standard procedure) and the 'interventional' group is the arm not receiving tubes.
~Details of the operative technique for endonasal DCR with tubes can be found in the following reference: Dolman PJ. Comparison of external dacryocystorhinostomy with nonlaser endonasal dacryocystorhinostomy. Ophthalmology. 2003 Jan;110(1):78-84. The group that will not receive tubes will undergo the same procedure except that the insertion of tubes will be omitted."
16280945|NCT00784979|Drug|CMVIG|400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
16280946|NCT00784966|Drug|etanercept|Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.
16280947|NCT00784966|Drug|etanercept|Etanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months.
16280948|NCT00784940|Drug|Anastrozole|1mg, orally, once daily
16280949|NCT00784940|Drug|Tamoxifen|20mg, orally, once daily
16280950|NCT00784927|Biological|rituximab|
16280951|NCT00784927|Drug|cyclophosphamide|
16280952|NCT00784927|Drug|dexamethasone|
16280953|NCT00784927|Drug|lenalidomide|
16280954|NCT00784914|Drug|temsirolimus|Receive temsirolimus IV
16280955|NCT00784914|Other|pharmacological study|Plasma levels of temsirolimus and sirolimus will be evaluated in serial blood samples.
16280956|NCT00784914|Other|cytokine levels|Dialysate samples are collected at regular intervals during the 96 hours following placement of the catheter to measure changes in levels of cytokines, chemokines and growth factors
16280957|NCT00784888|Other|Aromatase inhibitors|non-interventional study
16280958|NCT00784875|Drug|LY2624803|1 mg, oral capsule, once nightly before bedtime
16280959|NCT00784875|Drug|LY2624803|3 mg, oral capsule, once nightly before bedtime
16280960|NCT00784875|Drug|Placebo|matching placebo (capsule or tablet), once nightly before bedtime
16280961|NCT00784875|Drug|zolpidem|5 or 10 mg, oral tablet, once nightly before bedtime
16280962|NCT00784862|Drug|Anastrozole|1mg, orally, once daily
16280963|NCT00784862|Drug|Tamoxifen|20mg, orally, once daily
16280964|NCT00784849|Drug|Methylene blue|1 mC1
16280965|NCT00784836|Drug|BG9418 (interferon beta 1-a)|
16280966|NCT00784823|Drug|Bortezomib|"Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
~Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
~Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen"
16281008|NCT00784537|Drug|ABVD|"ABVD courses are scheduled every 28 days:
~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
~ABVD courses are scheduled every 28 days:
~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
~Randomization to Arm A (Observation)"
16281754|NCT00778700|Drug|Placebo Cream|Cream with no active drug
16280967|NCT00784823|Drug|Melphalan|"Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
~Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
~The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
~Melphalan will be given as a single dose (not split over 2 or more days)
~Dosing will be based body surface area calculated using actual body weight"
16280968|NCT00784810|Drug|Oxycodone/Naloxone|5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly
16280969|NCT00784810|Drug|Codeine/Paracetamol|15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly
16280970|NCT00784797|Drug|mifepristone and misopristol|200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses
16280971|NCT00784797|Drug|mifepristone and oxytocin|200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
16280972|NCT00784784|Biological|Fluviral|One dose
16280973|NCT00784784|Drug|Zanamivir|10 mg, OD, for duration of influenza season (10-23 weeks)
16280974|NCT00784771|Behavioral|Hypnotherapeutic Olfactory Conditioning (HOC)|
16280975|NCT00784758|Device|Fenzian Device|Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)
16280976|NCT00784758|Device|Sham Device|Three 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.)
16280977|NCT00784745|Drug|Dexamethasone|2mg morning and night for 5 days.
16280978|NCT00784732|Drug|QAV680|
16280979|NCT00784732|Drug|QAV680|
16280980|NCT00784732|Drug|Mometasone Furoate|
16280981|NCT00784719|Drug|CP-690,550|Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
16280982|NCT00784719|Drug|CP-690,550|Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
16280983|NCT00784719|Drug|CP-690,550|Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
16280984|NCT00784719|Drug|CP-690,550|Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
16280985|NCT00784719|Drug|Cyclosporine|Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
16280986|NCT00784719|Drug|CP-690,550 Vehicle|Ophthalmic topical solution, dosed at least once/day, 8 weeks
16280987|NCT00784706|Other|EP|Participants were asked to wear glasses with a patch on the right lens to block the visual stimuli from the right side and force them to receive the stimuli from the left-side visual field.
16280988|NCT00784706|Other|CIT|The CIT addressed forced use of the affected UE and restricted the unaffected UE during training. Shaping skills were delivered while participants were forced to use their affected UE in the mass practice of functional tasks, such as drinking water and opening a jar. Participants wore a mitt on their unaffected hand and wrist for 6 hours/day during the 3-week training and reported their compliance in a daily log.
16280989|NCT00784706|Other|conventional therapy|Traditional occupational therapy matched in intensity and duration with the other groups. The training program included stretching and weight bearing of the affected UE, improving the range of motion of the affected UE, muscle strengthening, and the practice of tasks used for functional training might involve the unaffected UE to assist in the affected UE; for example, stabilizing a bottle while opening its lid or moving pegs into holes on a board.
16280990|NCT00784693|Biological|Tanezumab|15 mg IV single dose
16280991|NCT00784693|Drug|Placebo|Placebo IV single dose
16280992|NCT00784680|Drug|Anastrozole|1mg, orally, once daily
16280993|NCT00784680|Drug|Tamoxifen|20mg, orally, once daily
16280994|NCT00784667|Drug|Cetuximab|400mg/m2 intravenously week 1, then 250 mg/m2 weekly intravenously
16280995|NCT00784667|Drug|Erlotinib|100mg orally daily continuously
16280996|NCT00784654|Drug|Lisdexamfetamine dimesylate (LDX)|LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
16280997|NCT00784654|Drug|Placebo|Placebo capsule once per day (double-blind period)
16280998|NCT00784641|Device|Novel Bausch & Lomb daily disposable contact lenses|Lenses to be worn and replaced daily for 2 weeks.
16280999|NCT00784641|Device|Bausch & Lomb SofLens daily disposable contact lenses.|Lenses to be worn and replaced daily for 2 weeks.
16281000|NCT00784641|Device|Johnson and Johnson 1-Day Acuvue Moist contact lenses|Lenses to be worn and replaced daily for 2 weeks.
16281001|NCT00784615|Procedure|Blood samples, transvaginal ultrasound|Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein
16281002|NCT00784589|Drug|General Corticotherapy|for patients with severe pemphigus : general corticotherapy Arm : 1.5mg/kg/d for 1 month, then 1.25mg/kg/d for 1 month, then 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 3 months, then 0.3 mg/kg/d for 3 months, then 0.2 mg/kg/d for 4 months, then 0.1 mg/kg/d for 4 months, for patients with moderated pemphigus : general corticotherapy Arm : 1mg/kg/d for 1 month, then 0.75mg/kg/d for 1 month, then 0.5mg/kg/d for 2 months, then 0.3 mg/kg/d for 2 months, then 0.2 mg/kg/d for 3 months, then 0.1 mg/kg/d for 3 months,
16281003|NCT00784589|Drug|Rituximab|for patients with severe pemphigus : rituximab Arm : 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 1 month, then 0.3 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, then 0.1 mg/kg/d for 1 month for patients with moderated pemphigus : rituximab Arm : 0.5mg/kg/d for 1 month, then 0.30 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month,
16281004|NCT00784563|Behavioral|Continuous training|The maximal heart rate (HRmax) in the exercise prescription was based on age[Goldberg, Elliot, and Kuehl1988] and reduced by 20% in participants who used beta-blockers.[Wonisch et al. 2003] The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
16281005|NCT00784563|Behavioral|Interval training|Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking [Wisloff et al. 2007].
16281006|NCT00784550|Drug|Tiotropium Bromide|Long-acting muscarinic antagonist
16281007|NCT00784550|Drug|Fluticasone Propionate/Salmeterol|Inhaled corticosteroid plus long-acting bronchodilator
16281207|NCT00783133|Drug|fexofenadine|Allegra 180 mg daily x 7 days
16281009|NCT00784537|Drug|ABVD and Radiotherapy|"ABVD courses are scheduled every 28 days:
~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15
~Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk)."
16281010|NCT00784524|Biological|allogeneic large multivalent immunogen breast cancer vaccine|Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.
16281011|NCT00784524|Biological|aldesleukin|Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.
16281012|NCT00784511|Dietary Supplement|cholecalciferol|4000 IU/d
16281013|NCT00784511|Other|microcrystalline cellulose|1/d
16281014|NCT00784498|Drug|Ketamine/Midazolam|Intravenous bolus of midazolam 0.1mg/kg in titrated dose of 1 mg/min until spontaneous eye closure or up to 5mg (whichever comes first) followed by ketamine 0.5-1mg/kg (up to 100mg) in titrated dose of 10mg/30 seconds, to achieve the desired level of sedation
16281015|NCT00784498|Drug|Propofol|Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation
16281016|NCT00784485|Drug|Xolair injections|In addition to Advair Diskus 250/50 or 500/50, subjects will receive 150 to 375 mg subcutaneous injection every 2 or 4 weeks (depending on IgE levels) for 16 weeks.
16281017|NCT00784472|Drug|oxycodone|intravenous according to patients weight, pn.
16281018|NCT00784472|Drug|morphine|intravenous administration according to patients weight, pn.
16281019|NCT00784459|Drug|abatacept|Treatment with abatacept, 10 mg/kg IV, for 5 doses.
16281020|NCT00784459|Drug|Placebo|Treatment with Placebo, IV
16281021|NCT00784446|Drug|Oxaliplatin, Capecitabine, Bevacizumab, Imatinib|"Dose level I:
~Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 100 mg/m2 Capecitabine days 1-14 bid: 800 mg/m2 Imatinib days 1-21: 300 mg
~Repeat on day 22.
~Dose level II:
~Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 130 mg/m2 Capecitabine days 1-14 bid: 1000 mg/m2 Imatinib days 1-21: 300 mg
~Repeat on day 22."
16281022|NCT00784433|Dietary Supplement|alcohol|150 cc
16281023|NCT00784420|Drug|UK-453,061|UK-453,061 1000 mg once daily for 10 days
16281024|NCT00784420|Drug|UK-453,061|UK-453,061 1000 mg once daily for 10 days
16281025|NCT00784420|Drug|Raltegravir|Raltegravir 400 mg twice daily for 10 days
16281026|NCT00784420|Drug|Raltegravir|Raltegravir 400 mg twice daily for 10 days
16281027|NCT00784407|Device|harmonic scalpel device utilized intraoperatively|harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
16281028|NCT00784394|Drug|diindolylmethane|Given PO
16281029|NCT00784394|Other|placebo|Given PO
16281030|NCT00784394|Other|pharmacological study|Correlative studies
16281031|NCT00784394|Other|laboratory biomarker analysis|Correlative studies
16281032|NCT00784394|Other|quality-of-life assessment|Ancillary studies
16281033|NCT00784381|Device|computer-assisted counselling about target drugs|implementation in experimental units of a software coupled to electronic prescribing system . This software is operating in patients with creatinine clearance below 60 ml/mn. When a target drug is prescribed to such a patient, the software checks if the drug is contraindicated due to impaired renal function, and if not checks if the dose is appropriate relatively to creatinine clearance value
16281034|NCT00784368|Drug|ITCZ Oral Solution|ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks
16281035|NCT00784368|Drug|ITCZ-IV|200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days
16281036|NCT00784355|Procedure|Laparoscopic cholecystectomy|Surgery
16281037|NCT00784329|Device|Optical Frequency Domain Imaging (OFDI) System|Optical Frequency Domain Imaging(OFDI)System. Additional biopsy obtained from regions of normal appearing tissue. Up to an additional 20 minutes to standard Bronchoscopy
16281038|NCT00784316|Drug|metoprolol, amiodarone|to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery
16281039|NCT00784303|Drug|Lenvatinib (DTC Cohort)|24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
16281040|NCT00784303|Drug|Lenvatinib (MTC Cohort)|24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.
16281041|NCT00784290|Drug|Orantinib (TSU-68)|200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops
16281042|NCT00784277|Drug|oxycodone CR|flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
16281043|NCT00784277|Drug|oxycodone IR|10mg for 14 days
16281044|NCT00784277|Drug|Tapentadol ER (CG5503)|flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
16281045|NCT00784277|Drug|Tapentadol IR (CG5503)|50mg for 14 days
16281046|NCT00784277|Drug|Tapentadol IR (CG5503)|75mg for 14 days
16281047|NCT00784277|Drug|placebo|1 capsule for 14 days
16281048|NCT00784277|Drug|placebo|Tablets and capsules 2 x a day for 28 days
16281049|NCT00784238|Drug|Paliperidone|Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
16281050|NCT00784225|Drug|selenium|200 mcg daily for 7-12 years
16281051|NCT00784225|Drug|vitamin E|400 IU daily by mouth for 7-12 years
16281052|NCT00784225|Drug|vitamin E placebo|daily for 7-12 years
16281053|NCT00784225|Drug|selenium placebo|daily for 7-12 years
16281054|NCT00784212|Drug|BGG492|
16281055|NCT00784212|Drug|BGG492|
16281056|NCT00784212|Drug|Placebo|
16281057|NCT00784186|Drug|mifepristone+misoprostol|single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
16281058|NCT00784186|Drug|misoprostol|placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
16281059|NCT00784186|Drug|placebo|placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
16281060|NCT00784160|Drug|Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)|Lactic Acid
16281061|NCT00784147|Drug|Ibalizumab|Ibalizumab 800 mg IV every 2 weeks
16281062|NCT00784147|Drug|Ibalizumab|Ibalizumab 2000 mg IV every 4 weeks
16281063|NCT00784134|Drug|Alteplase|1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
16281064|NCT00784134|Other|Normal saline|1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses
16281065|NCT00784121|Drug|Lactic Acid|Lactic Acid (Dermacyd Breeze)
16281066|NCT00784108|Device|Modulated Imaging (MI)|Modulated Imaging measure effect of Photodynamic therapy treatment
16281067|NCT00784108|Other|Photodynamic therapy|Modulated Imaging measure effect of Photodynamic therapy treatment
16281068|NCT00784095|Other|Life completion and preparation|Subjects will discuss life review, issues of forgiveness and heritage and legacy.
16281069|NCT00784095|Other|Attention Control|Subjects will listen to a non-guided relaxation CD.
16281070|NCT00784082|Drug|Hydroxycarbamide, Hydroxyurea (drug)|hydroxyurea 20-25 mg/kg/day since at least 3 months
16281071|NCT00784069|Drug|Lactic Acid|Lactic Acid (Dermacyd Breeze)
16281072|NCT00784056|Drug|Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)|Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)
16281073|NCT00784043|Device|Cochlear Implant|Bilateral Implantation in children
16281074|NCT00784030|Other|Water|Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.
16281075|NCT00784017|Drug|asparaginase|5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
16281076|NCT00784017|Drug|recombinant asparaginase|5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
16281077|NCT00784004|Other|Breathing Patterns|"All subjects will breathe in four different breathing patterns which are provided by specific masks. Patterns are as the following:
~Breathing in through the nose only and out through the mouth only
~Breathing in through the mouth only and out through the nose only
~Breathing in and out through the nose only
~Breathing in and out through the mouth only"
16281078|NCT00783978|Other|whole blood sample|2 ml of whole blood for children 5 ml of whole blood for parents that will be used only if 1 mutation is found in children
16281079|NCT00783965|Drug|tazarotene|Applied to the skin
16281080|NCT00783965|Other|placebo|Applied to the skin
16281081|NCT00783952|Device|Cerebral/Somatic Tissue Oximeter device|"Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.
~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
16281082|NCT00783952|Device|Pulmonary artery catheter|Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.
16281083|NCT00783939|Drug|Lactic Acid|Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
16281084|NCT00783926|Biological|H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)|2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)
16281085|NCT00783913|Other|Visumotor Upper Extremity Training|Control
16281086|NCT00783913|Other|Anodal/Sham tDCS|Condition
16281087|NCT00783900|Other|metoprolol, biatrial pacing|Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol
16281088|NCT00783887|Other|Blood sample|Blood sample of 5 ml
16281089|NCT00783861|Drug|Lactic Acid|Lactic Acid (Dermacyd Femina)
16281090|NCT00783835|Drug|Long-Acting Methylphenidate|Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.
16281091|NCT00783822|Other|RGCT|rapid genetic counseling and testing
16281092|NCT00783796|Device|2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System|Treatment of a maximum of two de novo native coronary artery lesions in small vessels.
16281093|NCT00783757|Device|Optical Imaging|TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
16281094|NCT00783744|Drug|Insulin Glargine|In the morning to target FBG ≤ 100 mg/dl
16281095|NCT00783744|Drug|Glimepiride|Glimepiride 3 or 4 mg
16281096|NCT00783744|Drug|Metformin|At least 850 mg od
16281097|NCT00783744|Drug|Insulin monotherapy with premixed insulin NPH 30/70|Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl
16281098|NCT00783731|Drug|Low dose midazolam|
16281099|NCT00783718|Drug|vedolizumab|Vedolizumab for intravenous infusion
16281100|NCT00783718|Other|Placebo|Placebo intravenous infusion
16281101|NCT00783705|Other|placebo|Given orally
16281102|NCT00783705|Drug|inositol|Given orally
16281103|NCT00783692|Drug|vedolizumab|Vedolizumab for intravenous infusion
16281104|NCT00783692|Other|Placebo|Placebo intravenous infusion
16281105|NCT00783679|Device|NICO device|"Measurement of cardiac output and simultaneous blood sampling.
~The subjects' cardiac output will be measured by NICO device and also by thermodilution method. Simultaneously blood samples will be drawn from the pulmonary artery catheter and arterial line. The calculated and measured cardiac output values will be compared for accuracy."
16281106|NCT00783666|Drug|Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)|Lactic Acid
16281107|NCT00783653|Drug|Sunitinib|25 mg or 37,5 mg daily dose until DLT
16281108|NCT00783640|Drug|Lactic Acid|Drug: Lactic Acid (Dermacyd Femina)
16281109|NCT00783627|Procedure|Angiography|Angiography done at the J1 visit
16281110|NCT00783614|Drug|Aspirin 325mg|Patients randomized to Aspirin 325mg po daily versus placebo pill daily
16281111|NCT00783614|Drug|Antiretroviral therapy (ART)|Patients randomized to start ART immediately or defer use for 1 month
16281351|NCT00782041|Drug|Folinic acid|20 mg/m²
16281112|NCT00783601|Drug|Comparator: MK0524 + placebo|Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
16281113|NCT00783601|Drug|Comparator: MK0524 + montelukast|Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
16281114|NCT00783601|Drug|Comparator: placebo + montelukast|Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
16281115|NCT00783601|Drug|Comparator: Placebo|During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
16281116|NCT00783588|Biological|ISF35|Subjects participating in this study will receive up to two doses of 1x10^8, 3x10^8, or 1x10^9 autologous Ad-ISF35-transduced CLL B cells, depending on the dose they received in the previous Phase I trial.
16281117|NCT00783562|Other|Extension-oriented exercise program|The exercise program was composed of six graded sessions, two per week for three consecutive weeks. Sessions, each of one hour length, were conducted after the working hours in a wide room of the nursery school, gathering together all the teachers from each school. The exercises were selected in order to reinforce lumbar extension and to strengthen the primary stabilizers of the spine (transversus abdominis, oblique abdominal, multifidus, quadratus lumborum and erector spinae muscles)
16281118|NCT00783562|Other|Informative Brochure|The brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation
16281119|NCT00783549|Drug|an undetermined dose of GSK1292263|GSK investigational product or placebo
16281120|NCT00783549|Drug|ascending dose of GSK1292263|Ascending dose based on target exposures or placebo
16281121|NCT00783549|Drug|ascending dose of GSK1292263|An ascending dose based on target exposure
16281122|NCT00783549|Drug|ascending dose of GSK1292263|An ascending dose based on target exposures.
16281123|NCT00783549|Drug|ascending dose of GSK1292263|An ascending dose based on target exposure
16281124|NCT00783536|Drug|Etanercept + Methotrexate|
16281125|NCT00783536|Drug|DMARDS|
16281126|NCT00783523|Drug|Doxycycline or Placebo|Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
16281127|NCT00783510|Biological|adalimumab|As prescribed by treating physician
16281128|NCT00783510|Drug|Methotrexate|As prescribed by treating physician
16281129|NCT00783484|Drug|PF-03716539|PF-03716539 10 mg oral solution, single dose
16281130|NCT00783484|Drug|PF-03716539|PF-03716539 25 mg oral solution, single dose
16281131|NCT00783484|Drug|PF-03716539|PF-03716539 3 mg oral solution, single dose
16281132|NCT00783484|Other|Placebo|Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose)
16281133|NCT00783484|Drug|PF-03716539|PF-03716539 100 mg oral solution, single dose
16281134|NCT00783484|Drug|PF-03716539|PF-03716539 200 mg oral solution, single dose
16281135|NCT00783484|Drug|PF-03716539|PF-03716539 50 mg oral solution, single dose
16281136|NCT00783484|Other|Placebo|Placebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose)
16281137|NCT00783484|Drug|Midazolam|Midazolam 1 mg IV, single dose
16281138|NCT00783484|Drug|Midazolam + PF-03716539 (100 mg)|Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose
16281139|NCT00783484|Drug|Midazolam + PF-03716539 (50 mg)|Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose
16281140|NCT00783484|Drug|Darunavir|Darunavir 600 mg tablet twice daily for 9 days (Days 1-9)
16281141|NCT00783484|Drug|Darunavir + PF-03716539|Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)
16281142|NCT00783484|Drug|Maraviroc|Maraviroc 150 mg tablet once daily for 6 days (Days 1-6)
16281143|NCT00783484|Drug|Maraviroc +PF-03716539|Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)
16281144|NCT00783484|Drug|Maraviroc|Maraviroc 225 mg tablet once daily for 6 days (Days 1-6)
16281145|NCT00783484|Drug|Maraviroc +PF-03716539|Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)
16281146|NCT00783471|Drug|Erlotinib, Docetaxel|Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days
16281147|NCT00783471|Drug|Docetaxel, Erlotinib|Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days
16281148|NCT00783458|Drug|Mometasone Furoate Nasal Spray|One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray
16281149|NCT00783458|Drug|fluticasone nasal spray|One dose (2 sprays in each nostril) of fluticasone nasal spray
16281150|NCT00783445|Behavioral|Community-Based Exercise Program (C-FIT)|Participants will do 1 hour of exercise two to three times each week in a community setting for 1 year, while being supervised by a personal coach.
16281151|NCT00783445|Behavioral|Self-Help Exercise Program (HOME)|After a fitness evaluation, participants will be given an exercise prescription and recommendations for home-based, self-mediated progressive exercise. Participants will be expected to do 1 hour of exercise two to three times each week for 1 year.
16281152|NCT00783432|Drug|Astepro Nasal Spray (0.1% azelastine hydrochloride)|548 mcg (2 sprays per nostril) twice a day
16281153|NCT00783432|Drug|Astelin Nasal Spray (0.1% azelastine hydrochloride)|548 mcg (2 sprays per nostril) twice a day
16281154|NCT00783406|Drug|PF-00610355|dry powder inhaler, 1472 mcg, single dose
16281155|NCT00783406|Drug|PF-00610355|dry powder inhaler, 736 mcg, single dose
16281156|NCT00783406|Drug|PF-00610355|dry powder inhaler, 368 mcg, single dose
16281157|NCT00783406|Drug|Placebo|Placebo
16281158|NCT00783393|Drug|Temozolomide|Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.
16281159|NCT00783380|Biological|Virosomal influenza vaccine|Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
16281160|NCT00783380|Biological|Subunit influenza vaccine|Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients
16281161|NCT00783367|Drug|Lenalidomide|Lenalidomide: 10mg capsules, orally, once daily for each 28 day cycle for the duration of the study
16281162|NCT00783367|Drug|Dexamethasone|Dexamethasone: 8mg tablets, orally, once weekly on days 3, 10, 17, 24 of each 28 day cycle for the duration of the study;
16281163|NCT00783367|Drug|Rituximab|Rituximab: 375mg/m2 IV (in the vein), once weekly on days 1, 8, 15, 22 during month 3 of therapy
16281164|NCT00783354|Drug|desloratadine|"Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of rescue medication (Placebo) in case of symptoms for 2 months."
16281165|NCT00783354|Drug|desloratadine|"Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of rescue medication (desloratadine 5 mg) in case of symptoms for 2 months."
16281166|NCT00783341|Drug|GAP-134|
16281167|NCT00783341|Drug|placebo|
16281168|NCT00783328|Drug|PF-00299804|Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops.
16281169|NCT00783315|Behavioral|Call-Center Directed (CCD) Weight Loss Program|This program will be implemented by trained counselors of Healthways, Inc., and will use telephone, Web, and e-mail contacts to engage participants. There will be no in-person visits.
16281170|NCT00783315|Behavioral|In-Person Directed (IPD) Weight Loss Program|This program will be primarily implemented through in-person visits (including group sessions) with health counselors at Johns Hopkins University. Telephone, Web, and e-mail contacts will occasionally be used.
16281171|NCT00783315|Behavioral|Self-Directed Weight Loss Program|Participants will meet with study staff at the beginning of the study and will receive written information about weight loss.
16281172|NCT00783289|Other|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
16281173|NCT00783289|Biological|Benralizumab 25 mg|Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
16281174|NCT00783289|Biological|Benralizumab 100 mg|Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
16281175|NCT00783289|Biological|Benralizumab 200 mg|Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
16281176|NCT00783276|Drug|SYN115|100 mg single dose
16281177|NCT00783276|Drug|PLACEBO|PLACEBO
16281178|NCT00783263|Drug|Comparator: rosuvastatin 5 mg + ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
16281179|NCT00783263|Drug|Comparator: rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
16281180|NCT00783263|Drug|Comparator: rosuvastatin 10 mg + ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
16281181|NCT00783263|Drug|Comparator: rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
16281182|NCT00783250|Drug|Salbutamol + Tiotropium|Salbutamol 400 micrograms + Tiotropium 18 micrograms
16281183|NCT00783250|Drug|Placebo + Tiotropium|Placebo via MDI + Tiotropium 18 micrograms
16281184|NCT00783237|Drug|Mometasone|Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
16281185|NCT00783237|Drug|Placebo|Placebo nasal spray, single dose of 2 sprays per nostril
16281186|NCT00783224|Drug|Placebo for MF|Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
16281187|NCT00783224|Drug|Placebo for FP|Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
16281188|NCT00783224|Drug|Mometasone|Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
16281189|NCT00783224|Drug|Fluticasone|Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
16281190|NCT00783211|Drug|desloratadine|desloratadine, 5 mg oral tablets, once daily for 15 days
16281191|NCT00783211|Drug|fexofenadine|fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
16281192|NCT00783211|Drug|placebo|placebo, once daily for 15 days
16281193|NCT00783198|Biological|SCH 39641 6 Amb a 1-U|SCH 39641 6 Amb a 1-U sublingual tablets administered once daily
16281194|NCT00783198|Biological|SCH 39641 12 Amb a 1-U|SCH 39641 12 Amb a 1-U sublingual tablets administered once daily
16281195|NCT00783198|Biological|Placebo|matching placebo sublingual tablets administered once daily
16281196|NCT00783185|Behavioral|Cannabis-Consumption-Reduction-Training|8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse
16281197|NCT00783185|Behavioral|Social competence Training|8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences
16281198|NCT00783172|Drug|Gemcitabine|1000mg/m2, IV (in the vein) over 30 minutes after treatment with OGF; first cycle is consecutive seven weeks and one week off; subsequent cycles are three weeks on and one week off.
16281199|NCT00783172|Biological|Opioid Growth Factor (OGF)|Initial treatment is 150ug/kg (based on body weight of the patient) in a volume of 50ml sterile saline, IV (in the vein) over 45 minutes; subsequent treatments at dose of 250ug/kg
16281200|NCT00783159|Procedure|Power Training|Power training, Vitamin D substitution
16281201|NCT00783159|Procedure|Strength Training|Strength training, Vitamin D substitution
16281202|NCT00783159|Other|Control|Vitamin D substitution, Lifestyle consultation
16281203|NCT00783146|Drug|desloratadine|desloratadine, 5 mg oral tablets, once daily for 15 days
16281204|NCT00783146|Drug|fexofenadine|fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
16281205|NCT00783146|Drug|placebo|placebo, once daily for 15 days
16281206|NCT00783133|Drug|Desloratadine 5 mg|Clarinex 5 mg daily x 7 days
16281208|NCT00783120|Other|Repetitive transcranial magnetic stimulation|10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.
16281209|NCT00783120|Other|Sham repetitive transcranial magnetic stimulation|placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli
16281210|NCT00783107|Drug|Cyclosporine|Cyclosporine Inhalation Solution, Once Daily
16281211|NCT00783107|Drug|Placebo|
16281212|NCT00783094|Drug|Tadalafil 2.5 mg|oral, daily
16281213|NCT00783094|Drug|Tadalafil 5 mg|oral, daily
16281214|NCT00783094|Drug|Placebo|oral, daily
16281215|NCT00783081|Drug|K-134|K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
16281216|NCT00783081|Drug|Cilostazol 100 mg BID|Cilostazol 100mg BID for 26 weeks.
16281217|NCT00783081|Drug|Placebo|Placebo BID for 26 weeks.
16281218|NCT00783068|Drug|GTS-21, [3-(2,4-dimethoxybenzylidene)-anabaseine dihydrochloride]|Subjects will receive GTS-21 or placebo 3 day before injection of LPS (150 mg tid) and a single oral dose of 150 mg of GTS-21 or placebo the morning of LPS injection (07:00 AM). Subjects will then receive an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21 or placebo at 1 hour before LPS administration (t=0)
16281219|NCT00783068|Drug|Placebo|Subjects will receive placebo 3 day before injection of LPS (150 mg tid) and a single oral dose of 150 mg of placebo the morning of LPS injection (07:00 AM). Subjects will then receive an oral dose of 150 mg placebo at 08:00 AM and another oral dose of 150 mg placebo at 1 hour before LPS administration (t=0).
16281220|NCT00783068|Drug|Lipopolysaccharide E. Coli 113:H 10:K negative|Subjects will be randomized to oral pre-treatment with GTS-21 (150 mg tid 3 days before LPS injection and an oral dose of 150 mg GTS-21 on the morning of the day of the experiment (07:00 AM). Subjects will then receive an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21 or placebo at 1 hour before LPS administration (t=0). One hour after ingestion of the last dosage of the study drug, purified LPS prepared from E coli O:113 (2 ng/kg iv) will be injected intravenously.
16281221|NCT00783055|Other|Individually tailored programmes|Individualised intervention programmes based on individual wishes for daily activities
16281222|NCT00783042|Drug|Rosuvastatin|40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
16281223|NCT00783042|Drug|Placebo|Tablet, oral, once daily for 1 month (double blind)
16281224|NCT00783016|Drug|Morphine|
16281225|NCT00783003|Drug|GSK233705 and GW642444|Inhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination.
16281226|NCT00783003|Drug|GW642444|Inhaled Long acting Beta 2 agonist (LABA)
16281227|NCT00783003|Drug|GSK233705|Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
16281228|NCT00783003|Drug|Placebo|Matching placebo.
16281229|NCT00782990|Procedure|Surgical treatment: TVT|
16281230|NCT00782990|Procedure|Surgical treatment: colposuspension|
16281231|NCT00782977|Other|Nasal oxygen therapy|Arm 1: Nasal cannulae with no oxygen flow. Arm 2: Nasal cannulae with oxygen flow at 5 L/min Arm 3: Nasal cannulae with oxygen flow at 10 L/min
16281232|NCT00782951|Drug|Org 28611|single IV dose of Org 28611 3 mcg/kg after dental impaction surgery
16281233|NCT00782951|Drug|morphine sulfate|single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery
16281234|NCT00782951|Drug|Placebo|single IV dose of placebo after dental impaction surgery
16281235|NCT00782925|Other|educational program|Educational program will consist of 1, 2-hour, small-group (8-patient) session with a specialist physician in Physical and Rehablilitation Medecine. Workers will be given information about lower back pain, pain and psychosocial risk factors for persistent or recurrent back-related disability
16281236|NCT00782925|Other|exercise program|The exercise program will consist of 5, 90-minute, small-group (8-patient) sessions with a physical therapist. Healthcare workers will be taught exercises including warm-ups, floor exercises, and endurance training. Only one absence will be allowed, otherwise the worker will be considered as non-compliant.
16281237|NCT00782925|Other|Self-led exercises|Self-led exercises to perform as part of a daily exercise routine
16281238|NCT00782847|Behavioral|DiaNe consultation and support program|the DiaNe consultation and support program for clients with diabetic nephropathy consists of 4 sessions at 90-120 minutes conducted every week in a period of 4 weeks
16281239|NCT00782834|Drug|Nilotinib|400 mg orally twice daily until disease progression, intolerability or withdrawal of consent
16281240|NCT00782821|Drug|Rabbit Antithymocyte Globulin|rATG will be given 1.5mg/kg intravenous (IV) per dose.
16281241|NCT00782821|Drug|Velcade|Velcade will be given 1.3mg/m2 via intravenous push (IVP) per dose.
16281242|NCT00782821|Drug|Rituxan|Given via IV per group assignment.
16281243|NCT00782795|Drug|Pioglitazone|Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.
16281244|NCT00782795|Drug|Placebo|
16281245|NCT00782769|Drug|Oxybutinyn Vaginal Ring 4mg|
16281246|NCT00782769|Drug|Oxybutinyn Vaginal Ring 6mg|
16281247|NCT00782756|Other|radiotherapy (RT) in combination with temozolomide and bevacizumab|"Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
~Post RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles.
~Follow up: CBC weekly, comprehensive panel and urinalysis monthly, blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive testing (approximately 4months post RT, 1 year after diagnosis and then annually in long term survivors). Blood sample for correlative studies monthly."
16281248|NCT00782717|Drug|Nepafenac ophthalmic suspension, 0.1% (NEVANAC)|1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
16281249|NCT00782717|Other|Nepafenac ophthalmic suspension vehicle|1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
16281250|NCT00782717|Drug|Prednisolone acetate ophthalmic suspension (OMNIPRED)|One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
16281251|NCT00782691|Other|CT-FDG/PET scan of the head-and-neck region|CT-FDG/PET scan of the head-and-neck region
16281252|NCT00782665|Procedure|Biopsy|1 centimeter x 1/2 centimeter piece cut from uterus
16281253|NCT00782652|Drug|inhaled nitric oxide|Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
16281254|NCT00782652|Drug|nitrogen gas|Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
16281255|NCT00782639|Drug|Iopamidol injection 76%|Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
16281256|NCT00782639|Drug|iodixanol|Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
16281257|NCT00782626|Drug|everolimus|
16281258|NCT00782613|Drug|4,4-dimethyl-benziso-2H-selenazine|ALT-2074 in a 0.5% cream formulation
16281259|NCT00782613|Drug|Placebo|Placebo in a cream formulation
16281260|NCT00782600|Drug|suspension IR|50 mg IR suspension once daily for one day
16281261|NCT00782600|Drug|CR 1|50 mg shorter release CR once daily for one day
16281262|NCT00782600|Drug|CR 2|50 mg medium release CR once daily for one day
16281263|NCT00782600|Drug|CR 3|longer release SR formulation once daily for one day
16281264|NCT00782587|Drug|Chemophase|40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled
16281265|NCT00782574|Drug|AZD2281|Capsule Oral bid
16281266|NCT00782574|Drug|Cisplatin|IV every 3 weeks
16281267|NCT00782561|Drug|FG-3019|FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks
16281268|NCT00782548|Drug|KADIAN (morphine sulfate sustained-release) capsules|Capsules, 30 mg
16281269|NCT00782548|Drug|Avinza (morphine sulfate sustained-release) capsules|Capsules, 30 mg
16281270|NCT00782535|Drug|CHF 4226 pMDI|Inhaled solution, single therapeutic dose
16281271|NCT00782535|Drug|CHF 4226 pMDI|Inhaled solution, single supratherapeutic dose
16281272|NCT00782535|Drug|Placebo|Inhaled solution, single dose of placebo
16281273|NCT00782522|Procedure|Eccentric training program|Eccentric training program
16281274|NCT00782522|Procedure|Traditional training program|Traditional training program
16281275|NCT00782509|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16281276|NCT00782509|Drug|Olodaterol (BI 1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16281277|NCT00782509|Drug|Placebo|Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler
16281278|NCT00782496|Device|Education + new meter|Diabetes education and a new meter with basic features
16281279|NCT00782496|Device|Education + new meter + feature activation|Diabetes education and a new meter with advanced features
16281280|NCT00782483|Device|ThermoVision A20M Infrared Camera|FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
16281281|NCT00782483|Device|ScleroPLUS|Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.
16281282|NCT00782483|Device|3D Digital Camera|3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
16281283|NCT00782470|Behavioral|Recombinant Factor VIII (Kogenate, BAY 14-2222)|Subjects electing to stay on the prophylactic treatment (prospective)
16281284|NCT00782470|Behavioral|Recombinant Factor VIII (Kogenate, BAY 14-2222)|Subjects electing to switch to on-demand treatment (prospective)
16281285|NCT00782470|Behavioral|Recombinant Factor VIII (Kogenate, BAY 14-2222)|Subjects remaining on-demand treatment (retrospective)
16281286|NCT00782457|Procedure|RECTAL CANCER RESECTION|
16281287|NCT00782444|Procedure|Computer navigated knee replacement|Total knee replacement performed with the use of navigation system from Brainlab with the Profix total knee implant.
16281288|NCT00782444|Procedure|Conventional knee replacement|Conventional total knee replacement performed in a traditional way with the use of intramedullary rods, with the Profix implant.
16281289|NCT00782431|Biological|Vero cell derived, trivalent, seasonal influenza vaccine|Single intramuscular injection
16281290|NCT00782431|Biological|Licensed egg-derived, trivalent seasonal influenza vaccine|Single intramuscular injection
16281291|NCT00782418|Drug|Comparator: exenatide|exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.
16281292|NCT00782418|Drug|Comparator: exenatide|exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.
16281293|NCT00782418|Drug|Comparator: Placebo|5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.
16281294|NCT00782405|Drug|quetiapine|XR, 150-300mg
16281295|NCT00782405|Drug|mirtazapine|30-45 mg
16281296|NCT00782379|Drug|busulfan|110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
16281297|NCT00782379|Drug|cyclophosphamide|14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
16281298|NCT00782379|Drug|fludarabine phosphate|30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
16281299|NCT00782379|Drug|mycophenolate mofetil|15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
16281300|NCT00782379|Drug|tacrolimus|0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
16281301|NCT00782379|Procedure|allogeneic hematopoietic stem cell transplantation|Patients to received unmanipulated PBSCs on Day 0
16281302|NCT00782379|Procedure|peripheral blood stem cell transplantation|patients to receive unmanipulated PBSCs on day 0
16281303|NCT00782366|Genetic|SNP analysis|The patients in the intervention group will obtain genetic risk assessments based on genome-wide association studies.
16281304|NCT00782353|Drug|ANA598 200 mg bid or placebo|ANA598 200 mg bid or placebo
16281305|NCT00782353|Drug|ANA598 400 mg bid or placebo|ANA598 400 mg bid or placebo
16281306|NCT00782353|Drug|ANA598 800 mg bid or placebo|ANA598 800 mg bid or placebo
16281307|NCT00782340|Drug|Placebo|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16281308|NCT00782340|Drug|Droxidopa|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16281309|NCT00782327|Drug|Losartan|Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg
16281310|NCT00782327|Drug|Placebo|Daily placebo capsule
16281311|NCT00782301|Drug|maraviroc|maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
16281312|NCT00782301|Drug|etravirine|etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
16281313|NCT00782288|Drug|digitoxin|0.05mg tabs, once daily for 28 days
16281314|NCT00782288|Drug|digitoxin|0.1mg pills, once daily for 28 days.
16281315|NCT00782288|Other|placebo|pill taken once daily for 28 days
16281316|NCT00782275|Drug|bevacizumab|
16281317|NCT00782275|Drug|temsirolimus|
16281318|NCT00782262|Dietary Supplement|KicStart™|KicStart™ is a nutritionally complete, but lower energy formulated liquid meal. Two sachets of KicStart™ (one for breakfast and one for lunch) provides 450 cal of energy per day, 0.8 grams per kilogram ideal body weight of high quality protein, and the recommended daily allowances (RDI) of minerals, vitamins, trace elements, omega 3 and 6 essential fatty acids. The Kicstart is supplemented with some salads, carbohydrate free vegetables and a small piece of meat fish or chicken each day in order to achieve a total energy intake of approximately 850 kcals/day.
16281319|NCT00782249|Device|Vagus nerve stimulation paradigm #1|Vagus nerve stimulation parameters #1
16281320|NCT00782249|Device|Vagus nerve stimulation paradigm #2|Vagus nerve stimulation parameters #2
16281321|NCT00782249|Device|Vagus nerve stimulation paradigm #3|Vagus nerve stimulation parameters #3
16281322|NCT00782236|Device|Bone Graft Material|After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement.
16281323|NCT00782210|Drug|Olodaterol (BI1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16281324|NCT00782210|Drug|Olodaterol (BI1744)|Comparison of low and high doses on efficacy and safety in COPD patients
16281325|NCT00782210|Drug|placebo|Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler
16281326|NCT00782197|Device|PRGF Intraarticular injection|Three consecutive PRGF injections each one week apart.
16281327|NCT00782197|Device|Hyaluronic Acid Intraarticular injection|Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
16281328|NCT00782184|Drug|ezetimibe/simvastatin 10/40|ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
16281329|NCT00782184|Drug|atorvastatin 40 mg|atorvastatin 40 mg tablet once daily for 6 weeks
16281330|NCT00782184|Drug|atorvastatin 20 mg|All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
16281331|NCT00782171|Device|SLActive dental implant|"Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery.
~Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery.
~In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery."
16281332|NCT00782145|Other|educational intervention|
16281333|NCT00782145|Other|informational intervention|
16281334|NCT00782145|Other|internet-based intervention|
16281335|NCT00782145|Other|questionnaire administration|
16281336|NCT00782145|Other|study of socioeconomic and demographic variables|
16281337|NCT00782145|Other|survey administration|
16281338|NCT00782145|Procedure|psychosocial assessment and care|
16281339|NCT00782145|Procedure|quality-of-life assessment|
16281340|NCT00782145|Procedure|standard follow-up care|
16281341|NCT00782106|Biological|Recombinant human hyaluronidase + immune globulin intravenous|Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered
16281342|NCT00782106|Biological|Recombinant human hyaluronidase + immune globulin intravenous|"IV infusion of IGIV, 10% to determine pharmacokinetics
~Intervention as in Arm 1: Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered"
16281343|NCT00782093|Drug|volociximab|volociximab intravitreal injection
16281344|NCT00782080|Drug|Sedariston|St. John´s Wort (100 mg) Valerian Extract (50 mg)
16281345|NCT00782080|Drug|Placebo|Placebo
16281346|NCT00782067|Drug|Midostaurin (PKC412)|Midostaurin was provided as 25 mg soft gelatin capsules for oral administration.
16281347|NCT00782054|Other|Provase|NDC:60230-8573-0 Over the counter (OTC) moisturizer containing 2% dimethicone and a blend of endopeptidases. Use topically to affected area every 8 hours.
16281348|NCT00782054|Other|Control moisturizer|Over the counter (OTC) moisturizer containing 2% dimethicone. Use topically to affected area every 8 hours. Does NOT contain endopeptidases. Placebo intervention is identical to active intervention EXCEPT it does not contain endopeptidases.
16281349|NCT00782041|Drug|Oxaliplatin|85 mg/m²
16281350|NCT00782041|Drug|5-FluoroUracil|2,000 mg/m²
16281352|NCT00782028|Other|Centering parenting/Group well child care|Intervention families will receive well child care in a group format for the first 12 month of the child's life.
16281353|NCT00782028|Other|Standard Care|
16281354|NCT00782015|Dietary Supplement|Almonds|3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
16281355|NCT00782015|Dietary Supplement|Placebo Comparator:|NCEP Step 2 diet
16281356|NCT00782002|Biological|IMC-18F1|Cohorts 1-4 will receive IMC-18F1 intravenously for 4 weekly infusions, followed by a 2-week observation period. Cohort 5 will receive IMC-18F1 intravenously every other week for the first 6 weeks of therapy. Cohort 6 will receive IMC-18F1 every 3 weeks for the first 6 weeks for therapy. The starting dose in Cohort 1 will be 2mg/kg. The maximum dose of IMC-18F1 will not exceed 16mg/kg administered every week, 15mg/kg administered every other week, and 20mg/kg administered every 3 weeks. Dose escalation of 100% (2 x previous dose) if no dose limiting toxicities (DLTs) are observed in the first three patients within a cohort during the initial 6-week therapy period. Dose escalation increment will be reduced to 50% (1.5 x previous dose) following the occurrence of either grade 2 or higher AEs in 2 or more patients that are possibly, probably, or definitely-related to study medication or one DLT during the initial 6-week therapy period. No intrapatient dose escalation is allowed.
16281357|NCT00781976|Drug|AZD7295|700mg per day maximum
16281358|NCT00781976|Drug|Placebo|matched placebo
16281359|NCT00781963|Behavioral|Manual-based cognitive behavioral therapy for insomnia|Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.
16281360|NCT00781963|Behavioral|Non-directive sleep education|Manual-based non-directive sleep education provided in 5 group sessions by a health educator.
16281361|NCT00781950|Dietary Supplement|Flaxseed|30 grams of milled flaxseed per day in food products or on its own.
16281362|NCT00781950|Dietary Supplement|Placebo|Wheat and Mixed Dietary Oils
16281363|NCT00781937|Drug|liraglutide|Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
16281364|NCT00781937|Drug|placebo|Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
16281365|NCT00781924|Procedure|biopsy|ultrasound guided biopsy of tumors.
16281366|NCT00781911|Biological|Cixutumumab|Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
16281367|NCT00781911|Drug|depot octreotide|Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
16281368|NCT00781898|Drug|Depot naltrexone|Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
16281369|NCT00781898|Other|Treatment as Usual (TAU)|Treatment as Usual (TAU) community treatment provided to the participant
16281370|NCT00781885|Drug|Beraprost sodium modified release|Tablets 60mcg
16281371|NCT00781872|Biological|Injection of autologous bone marrow derived mesenchymal stem cells|60 million cells intrathecally (approximately 1 million cells per Kg of body weight) and 20 million cells intravenously
16281372|NCT00781859|Drug|125 µg Ocriplasmin|125µg ocriplasmin intravitreal injection
16281373|NCT00781859|Drug|Placebo|Placebo intravitreal injection
16281374|NCT00781846|Drug|ridaforolimus|oral tablets, daily for 5 days/week
16281375|NCT00781846|Drug|bevacizumab|IV infusion
16281376|NCT00781833|Device|Radio Frequency Microstimulator|Implantable peripheral muscle microstimulator, delivering controlled pulsatile stimulation to femoral nerves for knee extension and peroneal nerves for dorsiflexion.
16281377|NCT00781820|Drug|Bifonazole cream 1%|1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
16281378|NCT00781820|Drug|Placebo cream|1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
16281379|NCT00781807|Other|multi-module rehabilitation program|"The multi-module rehabilitation program includes:
~Nutrition management
~Home-based ergometer training program
~Psychosocial support"
16281380|NCT00781794|Drug|NSA-789 at 2 different doses|
16281381|NCT00781781|Drug|Alemtuzumab|High risk: Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive) Low risk: Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
16281382|NCT00781768|Drug|Standard PO (Zofran + Dexamethason)|Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
16281383|NCT00781768|Drug|Aprepitant (MK-869) + Standard PO|Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
16281384|NCT00781755|Drug|varenicline|.5mg/day for 3 days then titrated to 1.0mg/day for 11 days. A total dosing regimen of 14 days.
16281385|NCT00781755|Behavioral|Adaptation of Motivational Interviewing|2 sessions of behavioral intervention designed to create ambivalence about quitting or plan for a quit attempt if the patient is ready.
16281386|NCT00781742|Drug|AZD6765|IV once per dosing day, multiple times during the treatment period
16281387|NCT00781742|Drug|Placebo|0.9% saline IV once per dosing day multiple times during the treatment period
16281388|NCT00781729|Behavioral|Yoga, one hour class, 3 times per week, for 24 weeks|Yoga, one hour class, 3 times per week, for 24 weeks
16281389|NCT00781729|Behavioral|Luncheon Seminar Series, once per month, for 24 weeks|Luncheon Seminar Series, once per month, for 24 weeks
16281390|NCT00781716|Device|Drug eluting coronary stent system|Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
16281432|NCT00781443|Drug|placebo|Repeating subcutaneous injection
16281391|NCT00781703|Other|DIAMOND depression care model|Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the PHQ9, treatment adjustment as indicated, psychiatric consultation, relapse prevention.
16281392|NCT00781690|Device|Evodial hemodialysers and Evodia blood lines|Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose
16281393|NCT00781664|Other|AN2718|AN2718 Cream SF Vehicle, Daily for up to 21 days
16281394|NCT00781664|Drug|AN2718|AN2718 Cream SF, 0.3%, Daily for up to 21 days
16281395|NCT00781664|Drug|AN2718|AN2718 Cream SF, 1%, Daily for up to 21 days
16281396|NCT00781664|Other|AN2718|AN2718 Gel Vehicle, Daily for up to 21 days
16281397|NCT00781664|Drug|AN2718|AN2718 Gel, 1.5%, Daily for up to 21 days
16281398|NCT00781664|Drug|AN2718|AN2718 Gel, 2.5%, Daily for up to 21 days
16281399|NCT00781664|Drug|AN2718|AN2718 Gel, 5%, Daily for up to 21 days
16281400|NCT00781664|Drug|AN2718|AN2718 Gel, 7.5%, Daily for up to 21 days
16281401|NCT00781664|Other|Sodium Lauryl Sulfate|Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
16281402|NCT00781638|Device|Adacolumn®|The medical device Adacolumn® (CE-Mark Certificate G1 07 01 366 76013) is an adsorptive type extracorporeal apheresis column. It has been shown to effectively improve clinical and endoscopic signs and symptoms in UC in adults by removing granulocytes and monocytes and by changing the Cytokine production.
16281403|NCT00781625|Dietary Supplement|UREX-cap-5|Size 3, white/white capsule, each containing 180 mg of a standardized, light beige fine powder consisting of freeze-dried cultures of: Lactobacillus rhamnosus, GR-1® (50%) Lactobacillus reuteri, RC-14® (50%) Ingredients Powder: Cultures, glucose anhydrate, potato starch, microcrystalline cellulose and magnesium stearate. Capsule: Gelatine, titanium dioxide Concentration Minimum of 5.4 billion (5.4 x 109) Colony Forming Units per capsule by end of bulk shelf life. Application For use as a dietary supplement. Packaging 20,000 capsules packaged in heat-sealed foil pouch.
16281404|NCT00781625|Dietary Supplement|UREX-cap-5|Size 3, white/white capsule, each containing 180 mg of a standardized, light beige fine powder consisting of freeze-dried cultures of: Lactobacillus rhamnosus, GR-1® (50%) Lactobacillus reuteri, RC-14® (50%) Ingredients Powder: Cultures, glucose anhydrate, potato starch, microcrystalline cellulose and magnesium stearate. Capsule: Gelatine, titanium dioxide Concentration Minimum of 5.4 billion (5.4 x 109) Colony Forming Units per capsule by end of bulk shelf life. Application For use as a dietary supplement. Packaging 20,000 capsules packaged in heat-sealed foil pouch.
16281405|NCT00781625|Dietary Supplement|Placebo Y cap G-3|Size 3, white/white capsule, each contaiing180 mg placebo blended powder. Daily oral and vaginal intake for a total duration of 6 months
16281406|NCT00781612|Drug|Docetaxel|Docetaxel will be administered as per local prescribing information.
16281407|NCT00781612|Drug|Paclitaxel|Paclitaxel will be administered as per local prescribing information.
16281408|NCT00781612|Drug|Pertuzumab|Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
16281409|NCT00781612|Drug|Trastuzumab|Trastuzumab will be administered as per local prescribing information.
16281410|NCT00781612|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
16281411|NCT00781612|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
16281412|NCT00781599|Drug|Chantix|Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3
16281413|NCT00781599|Behavioral|Adherence Counseling|Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change.
16281414|NCT00781599|Behavioral|Standard Counseling|Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
16281415|NCT00781586|Dietary Supplement|One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)|One A Day Weight Smart Advanced 1 tablet at 1st visit
16281416|NCT00781586|Drug|Caffeine|Caffeine 100 mg 1 tablet at 1st visit
16281417|NCT00781586|Drug|Placebo|Placebo 1 tablet at 1st visit
16281418|NCT00781573|Drug|Clopidogrel|Clopidogrel, 75 mg QD, for one year
16281419|NCT00781547|Drug|recombinant human growth hormone|The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
16281420|NCT00781534|Drug|Ginseng|Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups
16281421|NCT00781534|Drug|Ginseng|
16281422|NCT00781534|Drug|ginsenoside RE|active metabolite of ginseng
16281423|NCT00781534|Dietary Supplement|Placebo (sugar pill)|placebo group
16281424|NCT00781521|Drug|ofloxacin otic solution 0.3%|ofloxacin otic solution 0.3% instilled twice a day for seven days
16281425|NCT00781508|Drug|sildenafil|Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
16281426|NCT00781508|Other|Placebo|Changes in left ventricular filling pressure 1 hour after oral administration of placebo
16281427|NCT00781495|Device|Sensewear Bodymedia armband|To assess physical activity levels patients will wear Sensewear bodymedia armband
16281428|NCT00781482|Drug|eszopiclone, zolpidem, placebo|In random order, each subject will receive one study drug per visit over three visits. Visits will occur about 1 week apart. Each subject will eventually receive eszopiclone 3 mg., zolpidem 10 mg., and a placebo. PET scans will be done 1-2 hours after each dose.
16281429|NCT00781456|Drug|91-day Levonorgestrel Oral Contraceptive|91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
16281430|NCT00781456|Drug|Placebo|1 tablet daily to match experimental arm
16281431|NCT00781443|Drug|lebrikizumab (MILR1444A)|Repeating subcutaneous injection
16281434|NCT00781417|Dietary Supplement|Vitamin D|50,000 IU once a week for 12 weeks then every other week for 40 weeks
16281435|NCT00781417|Other|Placebo|Matching Placebo
16281436|NCT00781404|Drug|Adenosine|Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.
16281437|NCT00781391|Drug|warfarin tablets|Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
16281438|NCT00781391|Drug|Edoxaban tablets (high dose regimen-60mg)|Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
16281439|NCT00781391|Drug|Edoxaban tablets (low dose regimen-30mg)|Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
16281440|NCT00781391|Drug|placebo warfarin|placebo warfarin
16281441|NCT00781391|Drug|placebo edoxaban|placebo edoxaban
16281442|NCT00781378|Drug|rt-PA|rt-PA 100 mg continuous intravenous infusion for 2 hours
16281443|NCT00781378|Drug|rt-PA|rt-PA 50 mg continuous intravenous infusion for 2 hours
16281444|NCT00781365|Other|Telemonitors and pharmacy management|Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
16281445|NCT00781352|Drug|nitrous oxide|65% nitrous oxide administered during surgery
16281446|NCT00781352|Drug|nitrogen|Nitrogen administration during surgery
16281447|NCT00781339|Drug|sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate|0.1% NVC-422 in saline, up to 100 mL, Study Part 1 - once on Day 1 held in the bladder for 1 hour; Study Part 2 (Part 2a - 0.1% NVC-422, Part 2b - 0.2% NVC-422), once daily for 7 days, held in the bladder for 1 hour
16281448|NCT00781326|Drug|Nimodipine|Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.
16281449|NCT00781326|Drug|Placebo|Placebo will be given in doses matching those of nimodipine.
16281450|NCT00781300|Drug|Loteprednol Etabonate 0.5%|Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week
16281451|NCT00781300|Drug|Dexamethasone 0.1%|The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.
16281452|NCT00781287|Drug|3-drug anti-HIV therapy|3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
16281453|NCT00781287|Drug|Raltegravir|400 mg BID PO
16281454|NCT00781274|Drug|MP-424|750 mg every 8 hours for 12 weeks
16281455|NCT00781274|Drug|Ribavirin|600 - 1000 mg/day based on body weight for 24 weeks
16281456|NCT00781274|Drug|Peginterferon Alfa-2b|1.5 mcg/kg/week for 24 weeks
16281457|NCT00781261|Drug|Zoledronic Acid|Subjects in the intervention group B will be given 5mg Zoledronic acid as a single injection.
16281458|NCT00781261|Drug|Placebo|Subjects in the control group will receive a placebo drug for a similar period
16281459|NCT00781248|Device|NG Shield|A device to reduce pain/discomfort related to nasogastric tube usage
16281460|NCT00781209|Procedure|Irradiation plus Stereotactic Radiosurgery|"Posterior Fossa Irradiation-total dose of 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
~Radiosurgical boost-total dose administered to each lesion will be titrated to the size of the metastatic focus as follows:
~Maximum Tumor Diameter:<2.0 cm; Assigned Dose:24 Gy. Maximum Tumor Diameter:2.1-3.0 cm;Assigned Dose:18 Gy. Maximum Tumor Diameter:3.1-4.0 cm;Assigned Dose:15 Gy."
16281461|NCT00781196|Drug|folic acid|capsule 0.5 mg once a day
16281462|NCT00781196|Drug|placebo|capsule, once a day
16281463|NCT00781183|Other|pulmonary rehabilitation|6-weeks of in-patient pulmonary rehabilitation or 12-weeks of out-patient pulmonary rehabilitation
16281464|NCT00781170|Procedure|allogeneic hematopoietic SCT|
16281465|NCT00781157|Drug|Phenylephrine bolus|"The initial dose of phenylephrine will be 100 mcg, a dose within the clinical range currently in use at our center. The subsequent dose is based upon the response of the preceding subject in the usual up-and-down method (UDM), which is outlined in the data analysis section of the protocol. The dosing changes will be in increments of 20 micrograms. A successful response to this dose will be entered into a spreadsheet, designed by our statistician, which will determine the subsequent dose based upon the UDM. If a failure is observed in the previous subject, the dose is stepped up in the next subject. If a success is observed the next subject is randomized with probability of 0.10 to the next lower dose and with probability 0.90 to the same dose."
16281466|NCT00781131|Drug|Pregabalin|pregabalin 75 or 150 mg
16281467|NCT00781131|Drug|Placebo|lactulose placebo
16281468|NCT00781118|Device|Guardian System|There is no intervention in this study. The device is a diagnostic only.
16281469|NCT00781105|Drug|Telbivudine|600 mg/day, oral tablets, once daily, 52 weeks
16281470|NCT00781092|Other|Systane Ultra|Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
16281471|NCT00781092|Other|Bausch and Lomb Sensitive Eyes|Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
16281472|NCT00781079|Behavioral|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
16281473|NCT00781066|Procedure|Controlled cord traction|"Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn), hold it in one hand.
~Place the other hand just above the woman's pubic bone and stabilize the uterus by applying counter-pressure during controlled cord traction.
~Keep slight tension on the cord and await a strong uterine contraction (2-3 minutes).
~With the strong uterine contraction, encourage the mother to push and very gently pull downward on the cord to deliver the placenta. Continue to apply counter-pressure to the uterus.
~If the placenta does not descend during 30-40 seconds of CCT, do not continue to pull on the cord:
~Gently hold the cord and wait until the uterus is well contracted again;
~With the next contraction, repeat CCT with counter-pressure."
16281474|NCT00781066|Procedure|No controlled cord traction|"Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn).
~No CCT will be used and no fundal pressure. The placenta will be delivered physiologically, and signs for placental separation will be awaited (gush of blood from the vagina, descent of the umbilical cord, and increase in the height of the uterus in the abdomen as the lower segment was distended).
~After separation, delivery of the placenta will be aided only by maternal expulsive efforts and/or gravity."
16281475|NCT00781053|Drug|P144 cream|P144 cream 0.03% will be used once a day during the whole extension period of 6 months. The patient will apply the cream by him/herself or with a help of a person uniformly in a 10% maximum affected surface until absorption
16281476|NCT00781040|Other|Severe sepsis vs. non-severe sepsis|To compare these two groups
16281477|NCT00781027|Procedure|Phacoemulsification|Comparison of longitudinal phacoemulsification and torsional phacoemulsification
16281478|NCT00781001|Drug|Cannabis|400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit
16281479|NCT00780988|Biological|Autologous tumor cell + CpG vaccine|
16281480|NCT00780988|Procedure|Autologous hematopoietic and immune cell rescue (transplantation)|
16281481|NCT00780975|Drug|Aplidin (plitidepsin)|Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
16281482|NCT00780962|Drug|N-Acetylcysteine (NAC)|"Experimental:
~Before CT: 3 g NAC IV in 500 cc of 0.9% Sodium-chloride
~After CT: 200 mg NAC/hour in 0.9% Sodium-chloride at 67 cc/hour for up to 24 hours."
16281483|NCT00780962|Drug|0.9% Sodium-chloride|"Placebo:
~Before CT: 500 cc 0.9% Sodium-chloride
~After CT: NS at 67 cc/hour for up to 24 hours."
16281484|NCT00780949|Other|intestinal biopsies|intestinal biopsies during routine endoscopy
16281485|NCT00780936|Procedure|femoral nerve block|
16281486|NCT00780923|Device|CPAP treatment|maintains upper airway patency and minimizes the obstructive events
16281487|NCT00780910|Drug|MP-424|750 mg every 8 hours for 12 weeks
16281488|NCT00780910|Drug|Ribavirin|600 - 1000 mg/day based on body weight for 24 weeks
16281489|NCT00780910|Drug|Peginterferon Alfa-2b|1.5 mcg/kg/week for 24 weeks
16281490|NCT00780884|Device|acupuncture|16 sessions of acupuncture treatment, twice a week.
16281491|NCT00780858|Drug|Ganirelix|Ganirelix 0.25mg s.c every 24 h starting stimulation day 6
16281492|NCT00780832|Behavioral|Dietary Caffeine reduction|Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
16281493|NCT00780832|Drug|Anticholinergic medication|Detrol LA 4mg. orally, once daily for 30 days
16281494|NCT00780819|Device|PoleStar N20 intraoperative MRI|low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)
16281495|NCT00780806|Biological|meningococcal B rLP2086 vaccine candidate|vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
16281496|NCT00780806|Procedure|Blood draw|Blood draw
16281497|NCT00780793|Drug|progressive spacing of TNF-blocker injections|"Experimental arm
~Progressive spacing of TNF-blocker injections according to the following algorithm :
~if DAS28 ≤ 2.6 at trimestrial assessment: go for step N+1
~if DAS28 > 2.6 and DAS28 change ≤ 0.6: continue at step N
~if DAS28 > 2.6 and DAS28 change > 0.6 : return to step N-1 (relapse as defined by the European expert consensus).
~Step 0 (inclusion) :
~Adalimumab 40 mg / 14 days
~Etanercept 50 mg / 7 days
~Step 1 :
~Adalimumab 40 mg / 21 days
~Etanercept 50 mg / 10 days
~Step 2 :
~Adalimumab 40 mg / 28 days
~Etanercept 50 mg / 14 days
~Step 3 :
~Adalimumab 40 mg / 42 days
~Etanercept 50 mg / 21 days
~Step 4 :
~TNF-blocker stop"
16281498|NCT00780793|Drug|DMARD maintenance|DMARD maintenance
16281499|NCT00780780|Drug|Triamcinolone + Nepafenac|Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months
16281500|NCT00780780|Drug|triamcinolone intravitreal injection|triamcinolone intravitreal injection
16281501|NCT00780767|Device|ANGIOJET RHEOLYTIC THROMBECTOMY|The Angiojet catheter is a double lumen catheter percutaneously introduced via the common femoral vein into the main pulmonary trunk or the affected pulmonary artery respectively. One lumen serves to deliver high pressure saline jets into the thrombus and the other effluent lumen serves for clot removal utilizing a localized pressure region (Venturi effect) that attracts the thrombus for fragmentation into small particles. The fragmented debris are then pushed out through the evacuation line as a result of the retrograde high pressure saline jets, finally transporting them into a collection bag.
16281502|NCT00780754|Drug|dutasteride|0.5mg
16281503|NCT00780754|Procedure|prostate biopsy|prostate biopsy
16281504|NCT00780741|Procedure|Immediate Office Probing|Nasolacrimal duct probing in an office setting with topical anesthesia and restraint of the infant.
16281505|NCT00780741|Procedure|Deferred Facility Probing|Nasolacrimal duct probing performed under general anesthesia in a hospital outpatient surgery center or an ambulatory surgery center.
16281506|NCT00780728|Drug|Sildenafil|
16281507|NCT00780715|Drug|Gliclazide MR|30mg daily increased to 60mg if HbA1c > 7% at 3 months
16281508|NCT00780715|Drug|Sitagliptin|Sitagliptin 100mg daily for 6 months
16281509|NCT00780715|Drug|Pioglitazone|Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
16281510|NCT00780715|Drug|Metformin|Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
16281511|NCT00780702|Drug|Airipiprazole|Participants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
16281512|NCT00780702|Drug|Placebo|Participants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
16281513|NCT00780676|Drug|Dasatinib|100 mg tablet by mouth daily
16281514|NCT00780676|Drug|AZD6244|75 mg by mouth twice daily.
16281515|NCT00780663|Drug|Quarfloxin|IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
16281516|NCT00780650|Drug|Atomoxetine|80 mg oral dose, once per day for 6 weeks
16281517|NCT00780650|Drug|Placebo|80 mg dose once per day for 6 weeks
16281518|NCT00780637|Drug|Bradykinin|Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.
16281519|NCT00780624|Device|NIPPV|Ventilator is Bird VIP.
16281598|NCT00779857|Device|AtriCure LAA Exclusion System|Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
16281520|NCT00780624|Device|NIPPV|Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
16281521|NCT00780624|Device|NIPPV|Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
16281522|NCT00780598|Drug|Tosedostat|"In Part A, approximately 70 subjects will be randomized to one of 2 dose regimens of tosedostat which will be administered orally, once daily. The dose regimens of tosedostat will be:
~120 mg for 6 months once daily, OR
~240 mg (induction dose) once daily for 2 months, followed by 120 mg(maintenance dose) for 4 months
~In Part B a further 130 subjects will receive the dose regimen of tosedostat identified in Part A as being appropriate, based on the interim analysis during Part A."
16281523|NCT00780585|Drug|SCH 900460|Subjects who participated in previous trials of Org 24448 (SCH 900460)
16281524|NCT00780572|Behavioral|ADE alert assistant|A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
16281525|NCT00780559|Behavioral|Tailored Diet and Physical Activity|Subjects will receive an individually tailored diet and physical activity enhancement program
16281526|NCT00780559|Behavioral|Standard of Care|Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
16281527|NCT00780520|Dietary Supplement|alanine-glutamine infusion|
16281528|NCT00780494|Drug|bevacizumab|Intravenous 15 mg/kg
16281529|NCT00780494|Drug|carboplatin|AUC 6, Intravenously Day 1 every 21 days
16281530|NCT00780494|Drug|capecitabine|850mg/m2, Orally twice daily days 1-14 every 21 days.
16281531|NCT00780481|Drug|Bradykinin|Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
16281532|NCT00780468|Behavioral|Existing diet plan|
16281533|NCT00780468|Behavioral|New diet plan|
16281534|NCT00780455|Drug|Interferon beta-1b, FRP within 15 days after randomization|Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization
16281535|NCT00780455|Drug|Interferon beta-1b, FRP about 6 weeks after randomization|Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.
16281536|NCT00780442|Drug|D-cycloserine|50 mg DCS
16281537|NCT00780442|Drug|Placebo|Placebo
16281538|NCT00780416|Drug|MP-424|750 mg every 8 hours for 12 weeks
16281539|NCT00780416|Drug|Ribavirin|600 - 1000 mg/day based on body weight for 24 weeks
16281540|NCT00780416|Drug|Peginterferon Alfa-2b|1.5 mcg/kg/week for 24 weeks
16281541|NCT00780416|Drug|Ribavirin|600 - 1000 mg/day based on body weight for 48 weeks
16281542|NCT00780416|Drug|Peginterferon Alfa-2b|1.5 mcg/kg/week for 48 weeks
16281543|NCT00780403|Drug|Desloratadine|desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
16281544|NCT00780403|Drug|Zyrtec® (cetirizine)|Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
16281545|NCT00780390|Other|Autonomic Function Assessment|
16281546|NCT00780377|Drug|Bradykinin|Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.
16281547|NCT00780351|Device|sustained low efficiency daily hemodiafiltration (SLEDD-f)|vancomycin 15mg/kg IV infusion on day 1 from 6PM to 8PM. Start SLEDD-f on day 2 from 9AM to 5PM.
16281548|NCT00780338|Other|Assets Getting To Outcomes|Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance
16281549|NCT00780325|Drug|CG100649 (2 mg)|CG100649 capsules: 2 mg, single oral administration (Part 1); CG100649 capsules: dose to be determined, single oral administration (the single CG100649 dose level used in Part 3 will be determined by part 1 and 2).
16281550|NCT00780325|Drug|Celecoxib|Celecoxib (Celebrex®) capsules: 200 mg; single oral administration (Part 1 and 3)
16281551|NCT00780325|Drug|Placebo capsules|Placebo capsules: 198 mg silicified microcrystalline cellulose + 2 mg talc, multiple oral administrations (Part 1 and 3)
16281552|NCT00780325|Drug|Naproxen|Naproxen (Naprosyn®) tablets: 500 mg, single oral administration (Part 3)
16281553|NCT00780325|Drug|Acetazolamide|Acetazolamide (generic, immediate release) tablets: 250 mg, single oral administration (Part 3)
16281554|NCT00780325|Drug|CG100649 (8 mg)|CG100649 capsules: 8 mg, single oral administration (Part 1); CG100649 capsules: dose to be determined, single oral administration (the single CG100649 dose level used in Part 3 will be determined by part 1 and 2).
16281555|NCT00780312|Other|physiotherapy|50 patients in this group get the existing hospital treatment: A 10 minute instruction in mouth opening exercises by a nurse. Furthermore they receive in all 6-7 sessions of physiotherapy treatment for a 5-6 weeks period with sessions of approximately 45 minutes. 2 months after having completed radiotherapy treatment they receive a final physiotherapy treatment. The treatment consists of instruction in active and passive exercises for mouth opening, stretching exercises for the neck and shoulder region, tongue exercises, mimic exercises, self administered lymph drainage and softening of fibrotic tissue.
16281556|NCT00780299|Device|hemodialysis with high permeability (HDHP)|HDHP (hemodialysis with high permeability) is a specific plasma epuration of inflammatory mediators
16281557|NCT00780299|Procedure|CVVH|hemofiltration intermittent dialysis
16281558|NCT00780286|Device|Polymer based lubricating liquid|5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
16281559|NCT00780286|Device|Moi-Stir|2 sprays (0.35 mL) of the radiolabeled commercial device. A blend of Water, sorbitol, carboxymethylcellulose, sodium, methylparaben, propylparaben, potassium chloride, dibasic sodium phosphate, calcium chloride, magnesium chloride, sodium chloride, flavor.
16281560|NCT00780273|Device|Ankylos Implants|ANKYLOS Implant System vs Certain PREVAIL Implant
16281561|NCT00780273|Device|Biomet 3i Prevail Implants|
16281562|NCT00780260|Behavioral|strengths-based case management|5 session individual strengths-based case management; peer-involvement v. no peer involvement
16281563|NCT00780234|Procedure|fluorescence bronchoscopy|examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
16281564|NCT00780234|Procedure|quantitative high resolution CT scan|High resolution CT scan of the chest
16281755|NCT00778700|Drug|Ruxolitinib Phosphate Cream|1.0% phosphate cream
16281565|NCT00780234|Drug|PIOGLITAZONE VS. PLACEBO 30 mg|"Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-
~activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare."
16281566|NCT00780208|Drug|Daytrana (methylphenidate patch)|Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
16281567|NCT00780195|Procedure|glucose clamp|2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
16281568|NCT00780195|Procedure|glucose clamp|2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
16281569|NCT00780195|Procedure|glucose clamp|2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
16281570|NCT00780195|Procedure|glucose clamp|2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
16281571|NCT00780182|Drug|CMX001|CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted
16281572|NCT00780169|Drug|sorafenib + FOLFIRI|"escalating doses of sorafenib and irinotecan
~sorafenib starting dose 400 mg/day
~irinotecan starting dose 80 mg/m2 on day 1"
16281573|NCT00780143|Drug|Plitidepsin plus Cytarabine|Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
16281574|NCT00780130|Other|No Intervention|male & female college students ages 20 to 50, asymptomatic normals
16281575|NCT00780104|Drug|Rapamycin, Mitoxantrone, Etoposide, Cytarabine|Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.
16281576|NCT00780104|Drug|Rapamycin + MEC|Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.
16281577|NCT00780091|Other|classical monitoring strategy|intensive on-site monitoring, consistently with the pharmaceutical industry practices
16281578|NCT00780091|Other|optimized monitoring strategy|optimized on-site monitoring, depending on patient's risk
16281579|NCT00780078|Procedure|extubation|extubation failure in patients intubated orotracheally
16281580|NCT00780052|Drug|c-myb AS ODN|Subjects will be admitted to the hospital to receive c-myb AS ODN as a 24-hour continuous intravenous infusion over 7 days. Dose level is increased with each new subject to determine if there is a MTD.
16281581|NCT00780039|Drug|Pegylated Liposomal Doxorubicin|Subjects will receive Caleyx 30 mg/m2 intravenously on Day 1 of each 4-week cycle, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
16281582|NCT00780039|Drug|Carboplatin|Subjects will receive carboplatin dosed to target AUC of 5 mg/mL.min, intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
16281583|NCT00780026|Drug|insulin|bolus or infusion 80 to 110 mg/dl
16281584|NCT00780013|Drug|metformin hydrochloride liquid 500 mg per 5 mL|
16281585|NCT00780000|Drug|Alvespimycin|Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT
16281586|NCT00779987|Drug|Autologous serum - Systane|20% autologous serum solution used four times a day for two weeks. Then 0.9% sodium chloride four times a day for one week. Finally, Systane (r) four times a day for two weeks.
16281587|NCT00779987|Drug|Systane - Autologous serum|Systane (r) four times a day for two weeks. Then 0.9% sodium chloride used four times a day for one weeks. Finally, 20% autologous serum solution four times a day for two week.
16281588|NCT00779974|Other|Evaluation|For this research study each enrolled subject will have a clinical exam, including range of motion (ROM), and strength testing. The lift off and belly compression tests will be performed. An ultrasound of the shoulder will be done to determine the integrity of the subscapularis tendon. An EMG will be done to determine functionality of the subscapularis.
16281589|NCT00779961|Procedure|Palatoplasty|Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
16281590|NCT00779961|Procedure|Palatoplasty|Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
16281591|NCT00779935|Biological|Remicade|Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
16281592|NCT00779922|Drug|lenalidomide|
16281593|NCT00779909|Drug|vitamin D3|oral supplementation once per day for 12 weeks of different daily doses: 500 IU, 2500 IU, or 5000 IU after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis.
16281594|NCT00779909|Other|Placebo|oral supplementation once per day for 12 weeks of a sugar pill after abstaining from oral hygiene measures (brushing, flossing or antiseptic mouth rinses) for a period of 4 weeks to allow accumulation of plaque and development of experimental gingivitis.
16281595|NCT00779896|Drug|Tazarotene|Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.
16281596|NCT00779883|Biological|ISF35|Subjects participating in this study will receive a single dose of 1x10^8, 3x10^8, or 1x10^9 autologous Ad-ISF35-transduced CLL B cells.
16281597|NCT00779870|Other|bronchoscopy|bronchoscopy under local anaesthetic and sedation to obtain endobronchial biopsies
16281751|NCT00778726|Drug|Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets|
16281599|NCT00779844|Procedure|bariatric coelioscopic surgical procedure|total intra-venous anesthesia (propofol and remifentanil) being delivered using a close-loop system with the Bispectral Index as the single input for the controller
16281600|NCT00779844|Procedure|supra-umbilical coelioscopic surgical procedure|total intra-venous anesthesia (propofol and remifentanil) being delivered using a closed-loop system with the Bispectral Index as the single input for the controller
16281601|NCT00779831|Drug|120 mg Pseudoephedrine hydrochloride extended release tablets|
16281602|NCT00779818|Device|Electrical acupuncture|Treatment by electrical acupuncture
16281603|NCT00779818|Device|Laser|Treatment by laser
16281604|NCT00779805|Drug|Pseudoephedrine hydrochloride 120 mg ER tablets|
16281605|NCT00779792|Drug|clobetasol|0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
16281606|NCT00779792|Drug|triamcinolone acetonide|0.5 mg ointment twice daily for 10 consecutive days
16281607|NCT00779792|Drug|tacrolimus|0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
16281608|NCT00779792|Drug|glycerol|0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
16281609|NCT00779792|Drug|vehicle ointment (paraffin oil/soft white paraffin)|0.5 mg vehicle ointment twice daily for 10 consecutive days
16281610|NCT00779779|Biological|Rotarix™|Two oral doses, with at least 4 weeks interval in-between
16281611|NCT00779766|Biological|HPV GSK 580299 vaccine|Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
16281612|NCT00779766|Biological|Placebo control|Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
16281613|NCT00779753|Dietary Supplement|Amino Acid Solution with different amount of Lysine|The infants will be placed on a standard Primene solution for the first 24 hours of the study to obtain baseline values. During the second 24 hours they will receive an amino acid solution that has a different amount of lysine currently found in Primene, all lipid, CHO, minerals, vitamins and trace elements will remain unchanged. The Parenteral lysine will be studied at the following intake levels: 100, 110, 120, 130, 135, 140, 145, 150 , 155, 165, 170, 180, 200, 230, 245, 260mg/kg/d. The minimum energy intake will be 85-90 kcal/kg/day.
16281614|NCT00779740|Drug|mometasone furoate|The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
16281615|NCT00779740|Drug|mometasone furoate|The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
16281616|NCT00779727|Procedure|Placement of drainages|
16281617|NCT00779714|Drug|DTIC (dacarbazine)|1000 mg/m2, d1 every 21 days
16281618|NCT00779714|Drug|paclitaxel + cisplatin|paclitaxel 200 mg/m2 cisplatin 50 mg/m2 d1 every 21 days
16281619|NCT00779714|Drug|treosulfan + cytarabine|treosulfan 2500 mg/m2, d2 cytarabine 100 mg/m2, d1-3 every 21 days
16281620|NCT00779701|Drug|Insulin|Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
16281621|NCT00779688|Device|Probe-based confocal laser endomicroscopy|ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.
16281622|NCT00779675|Biological|Infliximab|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
16281623|NCT00779649|Other|MoviPrep Kit|"Diet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure.
~Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption."
16281624|NCT00779649|Other|HalfLytely and Bisacodyl Tablets Bowel Prep Kit|"Diet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed.
~Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed"
16281625|NCT00779636|Drug|Desloratadine|Desloratadine 10 mg daily x 28 days
16281626|NCT00779636|Drug|Placebo|Placebo daily x 28 days
16281627|NCT00779610|Procedure|Vibration with flexion|Vibration with forearm flexion (active contraction)
16281628|NCT00779610|Procedure|Vibration without flexion|Vibration without forearm flexion (passive)
16281629|NCT00779597|Behavioral|SCION (Self care improvement through oncology nursing)-PAIN program|The intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve self care regarding pain management beginning with admission followed by booster session every third day and one follow up telephone counseling within 3 to 4 days after discharge from hospital.
16281630|NCT00779584|Drug|MK-8776|IV infusion
16281631|NCT00779584|Drug|Gemcitabine|IV infusion
16281632|NCT00779571|Behavioral|Crispbread|8 week low calorie diet
16281633|NCT00779558|Drug|Heparin sulfate infusion at 10 units/kg/hour|Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
16281634|NCT00779558|Drug|Placebo infusion|Infusion of normal saline
16281635|NCT00779545|Drug|Placebo|One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
16281636|NCT00779545|Drug|Mometasone furoate|One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
16281637|NCT00779545|Drug|Mometasone furoate|Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
16281638|NCT00779545|Drug|Mometasone furoate|Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
16281639|NCT00779545|Drug|Mometasone furoate|One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
16281640|NCT00779545|Drug|Mometasone furoate|Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
16281641|NCT00779532|Drug|Moxifloxacin|Capsules containing 400 mg moxifloxacin, on Day 14 only
16281642|NCT00779532|Drug|NOMAC-E2 (Org 10486-0 + Org 2317)|Tablets containing 2.5 mg NOMAC and 1.5 mg E2, once daily dosing, orally taken. Daily dose either NOMAC-E2 2.5/1.5 mg or 12.5/7.5 mg.
16281643|NCT00779532|Drug|Moxifloxacin placebo|Moxifloxacin-placebo capsule taken orally, Day -1 and Day 14 only
16281644|NCT00779532|Drug|NOMAC-E2 placebo|Tablets containing NOMAC-E2 placebo, once daily dosing, orally taken.
16281645|NCT00779519|Drug|TTP435|
16281646|NCT00779519|Drug|Placebo|
16281647|NCT00779506|Drug|Quetiapine Fumarate XR|oral, once daily, flexible dose
16281648|NCT00779493|Dietary Supplement|curcumin|curcumin 900mg twice daily by mouth
16281649|NCT00779493|Dietary Supplement|placebo|placebo capsule to simulate 900mg curcumin capsule
16281650|NCT00779480|Drug|KW-2449|KW-2449 50 mg capsules administered 3 or 4 times per day for 21-day cycles up to 6 cycles
16281651|NCT00779467|Drug|Neostigmine|utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
16281652|NCT00779467|Drug|Bupivacaine|
16281653|NCT00779467|Drug|fentanyl|fentanyl 2 mcg/ml
16281654|NCT00779454|Drug|Gemcitabine, Oxaliplatin, Capecitabine,|Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7
16281655|NCT00779454|Drug|Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine|Gemcitabine: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7 Panitumumab: 6 mg/kg day 1
16281656|NCT00779441|Drug|Zolpidem 10mg tablets|
16281657|NCT00779428|Drug|Tanespimycin|"Solution, IV
~This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)"
16281658|NCT00779402|Other|Control|Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.
16281659|NCT00779402|Biological|Sipuleucel-T|Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
16281660|NCT00779389|Drug|Erlotinib|Erlotinib 150mg will be taken once a day for 14-21days.
16281661|NCT00779389|Drug|Dasatinib + Placebo|Dasatinib (100 mg) once a day for 14-21 days.
16281662|NCT00779389|Drug|Erlotinib plus Dasatinib|Erlotinib (150 mg PO qD) plus Dasatinib (100 mg PO qD) 14-21 days
16281663|NCT00779389|Drug|Placebo|Placebo for 14-21 days.
16281664|NCT00779389|Drug|Erlotinib|Erlotinib 150 mg for 14-21 days.
16281665|NCT00779376|Drug|Zidovudine 300mg tablets|
16281666|NCT00779363|Device|rechargeable TANTALUS II|Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
16281667|NCT00779350|Drug|sertraline 100 mg tablets|
16281668|NCT00779337|Biological|Autologous AdE1- Latent Membrane Protein CTLs|Total dose 20-800 million CTL given in 4 equal doses (5-200 million CTL) given intravenously, at weekly intervals for the first cohort of 10 patients and twice a week for the second cohort of 10 patients.
16281669|NCT00779324|Drug|Amantadine Hydrochloride|100 mg every morning and noon
16281670|NCT00779324|Drug|Placebo|one placebo tablet every morning and 12 Noon
16281671|NCT00779311|Drug|sorafenib|Sorafenib will be administered daily starting day 1 at 200mg QOD at Dose Level 1; 200mg/day at Dose Level 2; 200mg BID (5 days on/ 2 days off) at Dose Level 3; 200mg BID at Dose Level 4; and 400mg BID at Dose Level 5.
16281672|NCT00779311|Drug|bevacizumab|Bevacizumab will be administered as 5mg/kg IV on Day 1 of each treatment cycle.
16281673|NCT00779311|Drug|mFOLFOX6 regimen|The mFOLFOX6 regimen will be administered on Day 1 of each treatment cycle. This regimen consists of oxaliplatin 85 mg/m2 IV given over 2 hours, leucovorin 400 mg/m2 IV given over 2 hours, and fluorouracil 400 mg/m2 IV bolus, followed by fluorouracil 1200 mg/m2 per day for 2 days continuous infusion.
16281674|NCT00779285|Drug|Pegylated Liposomal Doxorubicin|Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
16281675|NCT00779259|Drug|Theophylline 300mg|Single doses of theophylline 300 mg as an immediate-release oral solution 80mg/15ml concentration administered alone at 7 am on Day 1 after an overnight fast of at least 10 hours and along with quinine sulfate (2 x 324 mg capsules) at 7am on Day 12 after an overnight fast of at least 10 hours.
16281676|NCT00779259|Drug|Quinine 648 mg|648 mg quinine sulfate(2 x 324 mg capsules) initiated at 3pm on Day 5 and taken every 8 hours through Day 11 and co-administered with theophylline 300 mg as an immediate-release oral solution 80 mg/15 ml concentration at 7am on Day 12.
16281852|NCT00777933|Drug|cyclosporine|
16281677|NCT00779259|Drug|Theophylline 300 mg|Single doses of theophylline 300 mg as an immediate-release oral solution 80mg/15ml concentration administered alone at 7 am on Day 1 after an overnight fast of at least 10 hours and along with quinine sulfate (2 x 324 mg capsules) at 7am on Day 12 after an overnight fast of at least 10 hours.
16281678|NCT00779259|Drug|Quinine 648 mg|648 mg quinine sulfate(2 x 324 mg capsules) initiated at 3pm on Day 5 and taken every 8 hours through Day 11 and co-administered with theophylline 300 mg as an immediate-release oral solution 80 mg/15 ml concentration at 7am on Day 12.
16281679|NCT00779246|Other|Nasal swabs for MRSA culture|Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.
16281680|NCT00779246|Drug|Chlorhexidine gluconate|CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.
16281681|NCT00779246|Other|Contact isolation|All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.
16281682|NCT00779233|Drug|Zidovudine tablets 300 mg|
16281683|NCT00779220|Drug|placebo|Intravenous repeating dose
16281684|NCT00779220|Drug|methotrexate|Oral repeating dose
16281685|NCT00779220|Drug|ocrelizumabu 50mg|Intravenous repeating dose (50mg)
16281686|NCT00779220|Drug|ocrelizumabu 200mg|Intravenous repeating dose (200mg)
16281687|NCT00779220|Drug|ocrelizumab 500mg|Intravenous repeating dose (500mg)
16281688|NCT00779207|Behavioral|weight loss and exercise|10% weight loss through diet and exercise plus multicomponent exercise training three times a week
16281689|NCT00779207|Behavioral|weight loss|10 percent weight loss through diet and behavioral modification
16281690|NCT00779194|Drug|Rapamycin|Rapamycin, is given to this group at a starting dose of 2 mg/day.
16281691|NCT00779181|Drug|ADX415|ADX415 taken three times a day to achieve a high total daily dose
16281692|NCT00779181|Drug|ADX415|ADX415 taken three times a day to achieve a mid level total daily dose
16281693|NCT00779181|Drug|ADX415|ADX415 taken three times a day to achieve a low total daily dose
16281694|NCT00779181|Drug|Placebo|Placebo taken three times a day
16281695|NCT00779168|Drug|white button mushroom extract|For this dose escalation study 6 patients will be treated at each of the following dosages: 4 grams PO daily, 6 grams PO daily, 8 grams PO daily, 10 grams PO daily, 12 grams PO daily and 14 grams PO daily.
16281696|NCT00779168|Other|flow cytometry|Immune cell subset number will be evaluated by flow cytometry on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.
16281697|NCT00779168|Other|immunologic technique|Testing will be performed on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.
16281698|NCT00779168|Other|laboratory biomarker analysis|Performed on blood samples collected pre-study (within 4 weeks of registration) and during weeks 3, 5, 9, 13, every 4 weeks beyond week 13 and at off study.
16281699|NCT00779168|Other|gas chromatography-mass spectrometry|Gas Chromatography-Mass Spectrometry (GC-MS) will be used to evaluate C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.
16281700|NCT00779168|Other|pharmacological study|Evaluation of C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.
16281701|NCT00779155|Device|The Resonator|active magnetic field therapy
16281702|NCT00779155|Device|The Resonator control|inactive magnetic field therapy with placebo fields
16281703|NCT00779142|Drug|Methotrexate intravenous 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
16281704|NCT00779129|Drug|Pegylated Lyposomal Doxorubicin|Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
16281705|NCT00779129|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
16281706|NCT00779116|Drug|Desloratadine|SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
16281707|NCT00779116|Drug|Zyrtec® (cetirizine)|Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
16281708|NCT00779103|Drug|Histrelin Subcutaneous Implant|histrelin subcutaneous 50 mg implant
16281709|NCT00779090|Procedure|Alveolar recruitment manoeuvre|Increase airway pressure during pressure controlled ventilation up to peak-airway pressure of 40 cmH20 and PEEP of 15 cmH20.
16281710|NCT00779064|Drug|Rivaroxaban (BAY59-7939)|10mg BID, Semi-sequential, dose escalation.
16281711|NCT00779064|Drug|Rivaroxaban (BAY59-7939)|20mg BID, Semi-sequential, dose escalation.
16281712|NCT00779051|Drug|Zolpidem 10mg tablets|
16281713|NCT00779038|Drug|Fentanyl ITS|40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.
16281714|NCT00779025|Device|PD-F-5254|Female Personal Lubricant (MINE)
16281715|NCT00779025|Device|10855-096|Male Personal Lubricant (YOURS)
16281716|NCT00779012|Biological|Infliximab|Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
16281717|NCT00778999|Drug|Marvelon|oral contraceptive 1 tablet daily for 14 to 21 days
16281718|NCT00778986|Device|heart failure remote patient monitoring system|remote monitoring of weight, blood pressure, ECG, and symptoms
16281719|NCT00778973|Drug|sertraline 100 mg tablets|
16281752|NCT00778713|Drug|Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets|
16281720|NCT00778960|Behavioral|Slow Breathing|The slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff.
16281721|NCT00778960|Behavioral|Meditation|The Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff.
16281722|NCT00778960|Behavioral|Meditation and slow breathing|A structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks.
16281723|NCT00778960|Behavioral|Sitting Quietly|"The SQ control group's intervention will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily."
16281724|NCT00778947|Procedure|Harmonic Synergy Dissecting Hook (Harmonic Scalpel)|Harmonic Synergy Dissecting Hook (Harmonic Scalpel) uses ultrasound waves to coagulate and cut in surgery. It is available on the market, holds a CE mark and is coded as a Class IIb medical device.
16281725|NCT00778947|Procedure|Electrocautery Diathermy|Electrosurgery uses high temperatures (150-400oC) and causes obliterative coagulation. Diathermy is the use of high frequency electric current to produce heat. In surgery it is used to cut or destroy tissue and/or to produce coagulation. The electrical frequency produced in diathermy is in the range of 300kHz to 3MHz.
16281726|NCT00778934|Other|Intimate Health Gel|Intimate Health Gel
16281727|NCT00778921|Drug|Amlodipine 10 mg|Amlodipine 10 mg
16281728|NCT00778921|Drug|Aliskiren 150|Aliskiren/Amlodipine 150/10 mg
16281729|NCT00778921|Drug|Amlodipine 300|Aliskiren/Amlodipine 300/10 mg
16281730|NCT00778908|Radiation|Late-course accelerated hyperfractionated IMRT|"IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease
~IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately."
16281731|NCT00778908|Drug|Concomitant cisplatin chemotherapy|cisplatin:40mg/m2 weekly infusion for 6 weeks
16281732|NCT00778908|Radiation|Conventionally fractionated IMRT|IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.
16281733|NCT00778895|Biological|GSK Biologicals' influenza vaccine GSK1557482A|one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
16281734|NCT00778895|Biological|Vaxigrip|one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
16281735|NCT00778882|Drug|VM106|Autologous hematopoietic stem cells with MT-gp91 retroviral vector
16281736|NCT00778869|Biological|Remicade|Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
16281737|NCT00778856|Procedure|Hand transplantation|allotransplantation of deceased donor composite tissue (hand and forearm)
16281738|NCT00778843|Dietary Supplement|Viusid|Viusid, three oral sachets daily during 24 weeks
16281739|NCT00778843|Other|Placebo|Placebo three oral sachets daily during 24 weeks
16281740|NCT00778830|Drug|Cetuximab|Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
16281741|NCT00778830|Drug|FOLFIRI|Irinotecan will be administered intravenously at a dose of 180 mg/m^2 along with folinic acid administration intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil will be administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
16281742|NCT00778830|Drug|FOLFOX|Oxaliplatin will be administered intravenously at a dose of 100 mg/m^2 along with folinic acid administration intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil administration intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
16281743|NCT00778817|Biological|IMC-A12|Given IV
16281744|NCT00778817|Drug|mitotane|Given orally
16281745|NCT00778804|Behavioral|telemedicine|Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement
16281746|NCT00778791|Drug|metformin HC1 750 mg extended-release tablets|
16281747|NCT00778778|Drug|cefprozil 500mg tablets|
16281748|NCT00778765|Drug|400 mg Gabapentin Capsules|
16281749|NCT00778752|Drug|Revlimid (Lenalidomide)|"3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall.
~If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall.
~If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials."
16281750|NCT00778739|Drug|CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL|
16281756|NCT00778700|Drug|Ruxolitinib Phosphate Cream|1.5% phosphate cream
16281757|NCT00778674|Drug|Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets|
16281758|NCT00778661|Drug|amoxicillin 400mg + clovalunic acid 57.5mg tablets|
16281759|NCT00778648|Dietary Supplement|Juice Plus|"Juice Plus+® is a dietary supplement from concentrated fruits (apple, orange, pineapple,cranberry, cherry (acerola), papaya and peach) and vegetables (carrot, parsley, beet, broccoli, kale, cabbage, spinach, and tomato).
~Subjects will take four capsules of Juice Plus+® daily."
16281760|NCT00778648|Dietary Supplement|Placebo|Four capsules of placebo daily.
16281761|NCT00778622|Drug|Metformin XR|Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
16281762|NCT00778609|Drug|EV/DNG (Qlaira, BAY86-5027)|Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval
16281763|NCT00778609|Drug|Encapsulated Microgynon + Placebo|Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
16281764|NCT00778596|Drug|Prednisolone|Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
16281765|NCT00778596|Drug|Placebo priming|Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.
16281766|NCT00778583|Drug|Nitrofurantoin 100 mg capsules|
16281767|NCT00778557|Drug|CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL|
16281768|NCT00778544|Drug|amoxicillin-clavulanic acid 600 mg- 42.9 mg/ 5 mL oral suspension|
16281769|NCT00778518|Drug|ARX201|Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
16281770|NCT00778518|Drug|ARX201|Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
16281771|NCT00778518|Drug|ARX201|Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
16281772|NCT00778505|Drug|Propofol|closed-loop administration using bispectral index as the controller
16281773|NCT00778505|Drug|remifentanil|closed-loop administration using bispectral index as the controller
16281774|NCT00778505|Drug|Propofol|manual administration according bispectral index values
16281775|NCT00778505|Drug|Remifentanil|manual administration according bispectral index values
16281776|NCT00778479|Device|Sepraspray|Max. 10g of Sepraspray
16281777|NCT00778466|Drug|metformin hydrochloride 1000 mg tablets|
16281778|NCT00778453|Other|Hospital-based mCIT|restraint of the unaffected arm and practice of the affected arm
16281779|NCT00778453|Other|Hospital-based BIT|bilateral symmetric, repetitive arm training
16281780|NCT00778453|Other|Hospital-based TR|hospital-based traditional rehabilitation : OT or PT or therapist-based training
16281781|NCT00778453|Other|Home-based mCIT|restraint of the unaffected arm and practices of the affected arm
16281782|NCT00778453|Other|Home-based BAT|bilateral symmetric, repetitive arm training
16281783|NCT00778453|Other|Home-based TR|home-based traditional rehabilitation:OT or PT or therapist-based training
16281784|NCT00778427|Drug|metformin hydrochloride 1000 mg tablets|
16281785|NCT00778414|Drug|Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension|
16281786|NCT00778401|Drug|Gabapentin tablets 800 mg|
16281787|NCT00778388|Biological|IC43|The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
16281788|NCT00778388|Drug|Placebo|The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
16281789|NCT00778375|Drug|Clofarabine|20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days.
16281790|NCT00778375|Drug|Cytarabine|20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions.
16281791|NCT00778375|Drug|Decitabine|20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
16281792|NCT00778349|Drug|Metformin solution 100 mg/mL|
16281793|NCT00778323|Procedure|limb remote ischemic preconditioning (LRIPC)|LRIPC consists of three 5-min cycles of right upper limb ischemia induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mmHg,with an intervening 5 min reperfusion during which the cuff is deflated.
16281794|NCT00778310|Drug|methylphenidate-OROS|The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan.
16281795|NCT00778310|Drug|Placebo|The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of placebo that are made to appear similar to Concerta capsules. The subject will be administered placebo the morning of the scan.
16281796|NCT00778297|Biological|Vaccination with FluvalAB FL-K-004 trivalent flu vaccine|Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).
16281797|NCT00778297|Biological|Vaccination with FluvalAB trivalent influenza vaccine|Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).
16281798|NCT00778284|Drug|Amoxicillin 400mg + clovalunic acid 57.5mg chewable tablets|
16281799|NCT00778271|Drug|Gabapentin 400mg capsules|
16281800|NCT00778258|Biological|Baked Milk|At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.
16281801|NCT00778258|Biological|Non-baked Milk|Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.
16281802|NCT00778245|Drug|cefprozil 500mg tablets|
16281803|NCT00778232|Drug|Gabapentin tablets 800 mg|
16281804|NCT00778219|Device|devices for tracheal intubation|tracheal intubation by laryngoscope or lightwand
16281805|NCT00778206|Drug|Kuvan|-Recommended post-partum Assessments include: collection of baby's plasma at Birth, 1 Month and 6 months, and collection of mother's plasma and expressed breast milk sample at 1 Month.
16281806|NCT00778193|Drug|Naproxen|1 tablet 500mg BID for 8 days
16281807|NCT00778193|Drug|Aspirin|1 tablet 81mg QD for 8 days
16281808|NCT00778193|Drug|Celecoxib|1 capsule 200mg QD for 8 days
16281809|NCT00778193|Drug|Clopidogrel|Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
16281810|NCT00778193|Drug|Placebo|1 capsule BID for 8 days
16281811|NCT00778180|Drug|furosemide 80 mg tablets|
16281812|NCT00778167|Biological|cixutumumab|Given IV
16281813|NCT00778167|Drug|erlotinib hydrochloride|Given PO
16281814|NCT00778167|Other|laboratory biomarker analysis|Correlative studies
16281815|NCT00778141|Drug|metformin HC1 750 mg extended-release tablets|
16281816|NCT00778128|Drug|CP-4126|Step 1: Dose escalation oral CP-4126 until maximum tolerated dose. Step 2: Oral CP-4126 day 1 and 15 + IV Gemcitabine 1000 mg/m2 day 8 in a 4 week schedule until complete response or disease worsening / progression
16281817|NCT00778128|Drug|Gemcitabine|Step 1: Dose escalation oral CP-4126 until maximum tolerated dose Step 2: Oral CP-4126 day 8 and 15 + IV Gemcitabine 1000 mg/m2 day 1 in a 4 week schedule until complete response or disease worsening / progression
16281818|NCT00778115|Drug|Loperamide HCl 2 mg and simethicone 125 mg tablets|
16281819|NCT00778102|Drug|5-FU|Bolus 400mg/m2, day 1 every 2 weeks
16281820|NCT00778102|Drug|5-FU|3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
16281821|NCT00778102|Drug|5-FU|2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
16281822|NCT00778102|Drug|Irinotecan|165mg/m2 1-hour iv infusion, day 1 every 2 weeks
16281823|NCT00778102|Drug|Leucovorin|400mg/m2 2-hour iv infusion, day 1 every 2 weeks
16281824|NCT00778102|Drug|Leucovorin|200mg/m2 2-hour iv infusion, day 1 every 2 weeks
16281825|NCT00778102|Drug|Oxaliplatin|85mg/m2 2-hour iv infusion, day 1 every 2 weeks
16281826|NCT00778102|Drug|bevacizumab [Avastin]|5mg/kg iv day 1 every 2 weeks
16281827|NCT00778089|Device|ArteFill® Skin Test|Subjects will receive the ArteFill® Skin Test at Visit 1, Day 0 on the volar forearm. After 30 days, if the test result is negative a second skin test will be administered on the contra volar forearm at Visit, 3, Day 30.
16281828|NCT00778076|Device|Hyaluronic acid|3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
16281829|NCT00778076|Device|Placebo (Saline injection)|3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
16281830|NCT00778063|Drug|dexmedetomidine|2 mcg/kg intranasally 30 minutes prior to surgery
16281831|NCT00778063|Drug|saline|a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
16281832|NCT00778050|Drug|Amoxicillin 600mg|
16281833|NCT00778037|Drug|Cyclobenzaprine hydrochloride 10 mg tablet|
16281834|NCT00778024|Drug|fluoxetine HCL 40 mg capsules|
16281835|NCT00778011|Drug|Ondansetron|dosage
16281836|NCT00778011|Drug|Ondansetron|4 mg
16281837|NCT00778011|Drug|Metoclopramide|10 mg IV
16281838|NCT00777998|Procedure|Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI|"*Multiple myeloma
~-> Induction Therapy (max. 8 cycles)
~-> Registration of patient, stem cell mobilization, start of donor search
~-> Melphalan (200mg/qm) plus autologous PBSCT
~-> 2 months later: Melphalan plus allogeneic PBSCT
~-> day 120 after allogeneic PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)
~-> day 180 after allogeneic PBSCT (if CsA discontinued): First DLI (1 x 10^6 (MRD) or 5 x 10^5 (MUD) CD3+ cells per kg BW)
~-> day 250 after allogeneic PBSCT: second DLI (if no signs of GvHD: dose escalation by 0,5 Log)
~-> Day 320 after allogeneic PBSCT: Third DLI (if no signs of GvHD: dose escalation by 0,5 Log)
~-> Further DLI depending on MRD-measurement"
16281839|NCT00777998|Procedure|auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide|"*Multiple myeloma
~-> Induction Therapy (max. 8 cycles)
~-> Registration of patient, stem cell mobilization, start of donor search
~-> Melphalan (200mg/qm) plus autologous PBSCT
~-> if no donor available (max 4 weeks after autologous PBSCT) or if patients declines allogeneic PBSCT): 2 months: Melphalan (200mg/qm) plus autologous PBSCT
~-> day 120 after autologous PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)"
16281840|NCT00777985|Drug|bosentan|62.5 mg b.i.d for 4 weeks
16281841|NCT00777985|Device|nasal continuous positive airway pressure (CPAP)|Daily application throughout sleep for 4 weeks
16281842|NCT00777972|Drug|Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets|
16281843|NCT00777959|Drug|ridaforolimus (MK8669)|Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.
16281844|NCT00777959|Drug|Comparator: Placebo|Three tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.
16281845|NCT00777959|Drug|open-label ridaforolimus (MK8669)|Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression.
16281846|NCT00777946|Drug|Aliskiren 300 mg|Aliskiren 300 mg tablet taken orally once a day with a glass of water.
16281847|NCT00777946|Drug|Aliskiren/Amlodipine 300/5 mg|Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
16281848|NCT00777946|Drug|Aliskiren/Amlodipine 300/10 mg|Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
16281849|NCT00777946|Drug|Placebo to Aliskiren|Placebo to Aliskiren tablet taken orally once a day.
16281850|NCT00777946|Drug|Placebo to Aliskiren/Amlodipine|Placebo to Aliskiren/Amlodipine taken orally once a day.
16281851|NCT00777933|Drug|tacrolimus|
16281853|NCT00777920|Drug|Ambrisentan|Tablet administered orally once daily
16281854|NCT00777907|Device|Pipeline Embolization Device (PED)|1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
16281855|NCT00777907|Device|Coil embolization|Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
16281856|NCT00777894|Radiation|3-dimensional conformal radiation therapy|"Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed.
~Phase I: Dose finding according to the following escalation table:
~Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week)
~(3 patients) 27 x 2 Gy = 54 Gy
~(3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy
~(3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy
~Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed."
16281857|NCT00777894|Radiation|intensity-modulated radiation therapy|"Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed.
~Phase I: Dose finding according to the following escalation table:
~Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week)
~(3 patients) 27 x 2 Gy = 54 Gy
~(3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy
~(3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy
~Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed."
16281858|NCT00777894|Radiation|stereotactic body radiation therapy|"Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed.
~Phase I: Dose finding according to the following escalation table:
~Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week)
~(3 patients) 27 x 2 Gy = 54 Gy
~(3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy
~(3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy
~(5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy
~Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed."
16281859|NCT00777868|Drug|Low Strength IDP-108|Topical application once a day for 9 months
16281860|NCT00777868|Drug|High Strength IDP-108|Topical application once a day for 9 months
16281861|NCT00777868|Drug|High Strength IDP-108 under occlusion|Topical application once a day for 9 months
16281862|NCT00777868|Drug|Vehicle|Topical application once a day for 9 months
16281863|NCT00777855|Drug|warfarin plus rifampin|warfarin 7.5mg po x 1; rifampin 600mg IV x 1
16281864|NCT00777855|Drug|warfarin|warfarin 7.5mg po x 1
16281865|NCT00777842|Device|GTX™ Drug Eluting Coronary Stent System|Drug eluting stent
16281866|NCT00777829|Drug|zolpidem|Participants will receive one dose of 10 mg before each nap.
16281867|NCT00777829|Drug|Placebo|Participants will receive a dose of placebo before each nap.
16281868|NCT00777816|Drug|XOMA 052|A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
16281869|NCT00777816|Drug|Placebo|A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
16281870|NCT00777803|Drug|NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))|NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
16281871|NCT00777803|Drug|OnabotulinumtoxinA (Vistabel®)|OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
16281872|NCT00777790|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16281873|NCT00777790|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16281874|NCT00777790|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16281875|NCT00777777|Device|eSVS, saphenous vein supporting mesh|Surgical coronary artery bypass grafting to the right coronary artery and the circumflex coronary artery with saphenous vein grafts, one will be supported by the eSVS(TM).
16281876|NCT00777764|Drug|Cohort I|"In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
~For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
~Dilutions of omalizumab and its excipients were in SWFI."
16281917|NCT00777491|Radiation|Induction BID radiation therapy|Twice daily (BID) on days 1-5,8-12,15-17. The first daily treatment consists of 1.6 Gy delivered to the pelvis. The second fraction consists of 1.5 Gy to the bladder for the first 5 treatment days. Then, 1.5 Gy is delivered to bladder tumor volume as the second treatment for the remaining 8 treatment days. The bladder tumor volume receives a total of 40.3 Gy.
16282090|NCT00776035|Procedure|Echocardiogram|an ultrasound of the heart
16281877|NCT00777764|Drug|Cohort 2|"In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.
~For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
~Dilutions of omalizumab and its excipients were made in saline."
16281878|NCT00777738|Drug|BORTEZOMIB|"Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push).
~For responding patients : up to 6 cycles
~For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days"
16281879|NCT00777725|Device|FibroScan|Liver scan, similar to an ultrasound.
16281880|NCT00777712|Other|Blood draw|Blood will be drawn from subjects once and VAC sponge will be collected (which is normally discarded material per standard of care).
16281881|NCT00777699|Drug|XL765 (SAR245409)|Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
16281882|NCT00777699|Drug|erlotinib|Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
16281883|NCT00777686|Procedure|MRI/MRS Scan|MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks.
16281884|NCT00777673|Drug|Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim|"Eligible patients will receive:
~nab-paclitaxel IV on days 1, 8, and 15. Treatment will be repeated every 28 days 28 days for 4 courses.
~Carboplatin IV on day 1. Treatment will be repeated every 28 days for 4 courses.
~Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 4 courses.
~After completion of the above regimen, patients will receive:
~Doxorubicin IV on day 1. Treatment will be repeated every 14 days for 4 courses.
~Cyclophosphamide IV on day 1. Treatment will be repeated every 14 days for 4 courses.
~Bevacizumab IV on day 1. Treatment will be repeated every 14 days for 2 courses.
~Patients will then proceed with:
~- Surgery including axillary staging
~A minimum of 4 weeks post operatively, patient will receive:
~- Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses."
16281885|NCT00777647|Other|Sugar-sweetened soft drink|One litre a day for six months.
16281886|NCT00777647|Other|Aspartame-sweetened soft drink|One litre a day for six months.
16281887|NCT00777647|Other|Semi-skimmed milk|One litre a day for six months
16281888|NCT00777647|Other|Water|One litre a day for six months.
16281889|NCT00777634|Other|No intervention.|There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.
16281890|NCT00777621|Other|Calorie Restriction|This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
16281891|NCT00777621|Other|Exercise|This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
16281892|NCT00777621|Other|Calorie Restriction and Exercise|This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
16281893|NCT00777608|Drug|Comparator: Placebo 5mg (run in)|Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.
16281894|NCT00777608|Drug|Donepezil 5 - 10 mg|"Donepezil 1 capsule (5 mg) orally, once daily for 14 days.
~Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84)."
16281895|NCT00777608|Drug|Comparator: Placebo 5-10 mg|"Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days.
~Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84)."
16281896|NCT00777608|Drug|Donepezil 10 mg|Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).
16281897|NCT00777595|Drug|CHF 4226 pMDI|Inhaled solution, single therapeutic dose
16281898|NCT00777595|Drug|CHF 4226 pMDI|Inhaled solution, single supratherapeutic dose
16281899|NCT00777595|Drug|Placebo|Inhaled solution, single dose of placebo
16281900|NCT00777595|Drug|Moxifloxacin|Tablet, oral, 400mg, single dose
16281901|NCT00777582|Drug|AZD2281|Oral single dose formulation
16281902|NCT00777569|Drug|Nicotine free cigarettes|Quest Step 2 contains 0.05 mg nicotine
16281903|NCT00777569|Drug|Extra-low nicotine cigarettes|Quest 2 cigarettes contains 0.3 mg nicotine
16281904|NCT00777569|Drug|Nicotine Lozenge|4 mg nicotine lozenge
16281905|NCT00777556|Drug|DR-104|One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.
16281906|NCT00777543|Other|ferulic acid|Ferulic acid is naturally contained in wholegrain bread. Bran is the main source of ferulic acid while is low in white flour. Ferulic acid is mainly covalently bound to fiber and low bioaccessible. The bran is pretreated to increase the bioavailability of ferulic acid by increasing the free ferulic acid released from the food matrix.
16281907|NCT00777543|Dietary Supplement|Treated bran bread|This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
16281908|NCT00777543|Dietary Supplement|wholegrain bread|The control is the wholegrain bread enriched with bran that has not been pretreated
16281909|NCT00777530|Drug|Bosutinib (SKI-606)|
16281910|NCT00777517|Drug|Lipitor|A single dose of 10 mg Lipitor tablet
16281911|NCT00777517|Drug|Atorvastatin pediatric formulation|A single dose of 10 mg atorvastatin pediatric formulation
16281912|NCT00777504|Drug|usage oral angiogenesis inhibitor|see under 'study arms'
16281913|NCT00777504|Drug|stop oral angiogenesis inhibitor|see under 'study arms'
16281914|NCT00777491|Drug|induction cisplatin|15 mg/m^2 administered as a 60-minute infusion on days 1,2,3,8,9,10,15,16,17.
16281915|NCT00777491|Drug|induction 5-fluorouracil|400mg/m^2 administered as a 24-hour infusion on days 1,2,3, and 15,16,17.
16281916|NCT00777491|Drug|induction gemcitabine|27 mg/m^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15, 18, 22, 25.
16282039|NCT00776568|Procedure|Extra-corporeal shockwave|Low intensity shock waves are applied as 300 shocks per visit for 09 visits. The treatment visit is carried at week 1, 5 and 9.
16282435|NCT00773383|Drug|RG1507|iv 9mg/kg weekly
16281918|NCT00777491|Radiation|Induction QD radiation therapy|Once daily (QD) on days (1-5,8-12,15-19,22-26). For the first 10 treatment days, 2 Gy is delivered to the pelvis. Then, 2 Gy is delivered to the bladder for the next 4 treatment days, followed by 2 Gy to the bladder tumor volume for the remaining 6 treatment days. The bladder tumor volume receives a total of 40 Gy.
16281919|NCT00777491|Radiation|Consolidation BID radiation therapy|Twice daily (BID) for 8 days on days 1,2,3,4,5,8,9,10 of consolidation. 1.5 Gy per fraction for a total of 24 Gy delivered to the pelvis.
16281920|NCT00777491|Radiation|Consolidation QD radiation therapy|Once daily (QD) pelvic radiation therapy for 12 days on days 1-5,8-12,15-16 of consolidation. 2 Gy per fraction for a total of 24 Gy delivered to the pelvis.
16281921|NCT00777491|Drug|consolidation gemcitabine|27 mg/m^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15 of consolidation.
16281922|NCT00777491|Drug|consolidation 5-fluorouracil|400 mg/m^2 administered as a 24-hour infusion on days 1, 2, 3 and 8, 9, 10 of consolidation.
16281923|NCT00777491|Drug|consolidation cisplatin|15 mg/m^2 administered as a sixty-minute infusion on days 1, 2, 8, 9 of consolidation.
16281924|NCT00777491|Procedure|radical cystectomy|Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation.
16281925|NCT00777491|Procedure|Post-Induction Chemoradiotherapy Endoscopic Response Evaluation|Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy.
16281926|NCT00777491|Drug|adjuvant gemcitabine|1000 mg/m^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles.
16281927|NCT00777491|Drug|adjuvant cisplatin|70 mg/m^2 administered as a sixty-minute infusion on day 1 of each 21-day cycle for four cycles.
16281928|NCT00777478|Drug|capiri-sutent|A dose escalating study in a 3 + 3 design will be performed. At MTD dose 14 additional patients will be treated. First, the optimal dose of sunitinib in a continuous schedule will be determined, thereafter, further dose escalation of capecitabine and irinotecan will be investigated.
16281929|NCT00777439|Drug|Domperidone|10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.
16281930|NCT00777413|Drug|Minocycline 100mg Tablets|
16281931|NCT00777400|Drug|Efalizumab|1 mg/kg of efalizumab administered sub q once weekly
16281932|NCT00777387|Procedure|slow-freeze|Slow-freeze-rapid-thaw procedure of oocytes is characterized by prolonged exposure of the cell to cryoprotectants in a low metabolic state at very low temperatures
16281933|NCT00777387|Procedure|vitrification|Vitrification is the process by which water is prevented from forming ice due to the viscosity of a highly concentrated cryoprotectant cooled at an extremely rapid rate
16281934|NCT00777374|Drug|Patch|epicutaneous application of allergen patch
16281935|NCT00777374|Drug|Placebo patch|epicutanoeus application of a placebo patch
16281936|NCT00777361|Drug|AZD3480|Iv single dose, 4-hour infusion of 25 mg
16281937|NCT00777361|Drug|AZD3480|Oral solution single dose of 50 mg
16281938|NCT00777348|Drug|Combination DSCG and Reproterol|1:
16281939|NCT00777335|Drug|Panobinostat - LBH589|Solution for infusion - 25mg/5ml
16281940|NCT00777335|Drug|Panobinostat - LBH589|Hard gelatine capsules - 5mg and 20 mg
16281941|NCT00777322|Procedure|Excimer laser ablation, and collagen cross-linking|Surgery is performed with topical anaesthesia. The central corneal epithelium is removed. Excimer laser ablation is applied (typically 15-30 seconds). Residual bed thickness is checked with an ultrasonic pachymeter. Topical application of riboflavin 0.1% in dextran is commenced at 5 minute intervals. When an adequate saturation of the anterior chamber with riboflavin has been achieved, cross-linking treatment will proceed. Output from the UV light generating equipment is measured with a UV light meter and set at 3mW/cm². Thirty minutes of treatment is given, interrupted at five minute intervals by the application of more topical riboflavin drops. Finally the eye has a bandage soft contact lens placed, with preservative free topical antibiotic, steroid, and cycloplegic drop application.
16281942|NCT00777309|Drug|ARQ 197|360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
16281943|NCT00777309|Drug|Erlotinib|Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
16281944|NCT00777309|Drug|Placebo|The placebo is provided as a capsule
16281945|NCT00777296|Drug|ARIKACE™|Study start date is before Jan 18, 2017.
16281946|NCT00777296|Drug|Placebo|Study start date is before Jan 18, 2017.
16281947|NCT00777270|Procedure|repair of episiotomy or second degree tears|continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
16281948|NCT00777270|Procedure|repair of episiotomy or second degree tears|interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture
16281949|NCT00777257|Biological|T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.|Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
16281950|NCT00777257|Biological|Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.|Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
16281951|NCT00777257|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap|Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
16281952|NCT00777244|Drug|MITOTANE|mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance on day 2 to 3 g/day, on day 3 to 4.5 g/day, and on day 4 to 6 g/day. A dose of 6 g/day will be administered until first mitotane blood level is assessed. Further adjustment of dosage will be performed according to blood concentrations and tolerability.
16281953|NCT00777231|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16281954|NCT00777218|Drug|propranolol|standard pediatric doses, based on body weight
16281955|NCT00777218|Drug|zonisamide|standard pediatric dosages, based on body weight
16281956|NCT00777218|Drug|topiramate|standard pediatric dosages, based on body weight
16282436|NCT00773383|Drug|erlotinib [Tarceva]|150mg oral daily
16281957|NCT00777205|Behavioral|Telephone-based peer support|Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
16281958|NCT00777205|Behavioral|Enhanced Usual Care|Patients received their usual mental health care plus a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
16281959|NCT00777192|Behavioral|Questionnaires|20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life
16281960|NCT00777179|Drug|Vandetanib|Tablet, oral, daily
16281961|NCT00777179|Drug|Placebo|Placebo
16281962|NCT00777166|Drug|oxytocin|oxytocin 5 units diluted with normal saline to a total volume of 10 mL
16281963|NCT00777166|Drug|oxytocin|oxytocin 10 units diluted with normal saline to at total volume of 10 mL.
16281964|NCT00777153|Drug|Cediranib|30 mg/day, oral, until progression
16281965|NCT00777153|Drug|Cediranib|20 mg/day, oral, until progression
16281966|NCT00777153|Drug|Lomustine Chemotherapy|110 mg/m2 / Q6W, oral, until progression
16281967|NCT00777153|Drug|Placebo Cediranib|Oral, until progression
16281968|NCT00777140|Drug|Deferoxamine|"Intravenous deferoxamine: bolus 10mg/Kg (initiated during thrombolytic infusion, iv tPA), followed by intravenous perfusion of 20/40/60mg/Kg during 72h. It's a dose-finding study with 3 different doses of deferoxamine, with 20 patients (15 active:5 placebo) in each step.
~Bolus + 72h perfusion of saline solution for the placebo group."
16281969|NCT00777127|Drug|Imiquimod|One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.
16281970|NCT00777127|Drug|Diclofenac|Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.
16281971|NCT00777114|Drug|bortezomib, tositumomab|"0.30mg/m2 bortezomib and 50cGy 131I-tositumomab,
~0.30 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
~0.60 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
~0.90 mg/m2 bortezomib and 75 cGy 131I-tositumomab, and
~1.2 mg/m2 bortezomib and 75 cGy 131I-tositumomab."
16281972|NCT00777101|Drug|Neratinib|Tablets 240 mg orally once per day until disease progression or unacceptable toxicity
16281973|NCT00777101|Drug|Lapatinib|Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.
16281974|NCT00777101|Drug|Capecitabine|Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
16281975|NCT00777088|Device|Pipeline Embolization Device (PED)|1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
16281976|NCT00777075|Drug|L-arginine|
16281977|NCT00777075|Drug|Placebo|
16281978|NCT00777062|Drug|VIVITROL (Naltrexone extended-release injectable suspension)|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.
16281979|NCT00777062|Drug|Placebo|Placebo injection at the start of weeks 2 and 6.
16281980|NCT00777049|Drug|Panobinostat|Hard gelatine capsule - 5mg and 20mg
16281981|NCT00777036|Drug|Dasatinib|
16281982|NCT00777023|Drug|Gabapentin Extended-Release (G-ER) 1200 mg|G-ER 1200 mg daily dosage given as two 600-mg tablets.
16281983|NCT00777023|Drug|Gabapentin Extended-Release (G-ER) 1800 mg|G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.
16281984|NCT00777023|Drug|Placebo|Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).
16281985|NCT00777010|Other|Ketogenic diet|carbohydrate restricted diet
16281986|NCT00777010|Other|Healthy high carbohydrate diet|higher carbohydrate diet
16281987|NCT00776997|Device|Magnetic Sphincter Augmentation|The area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed.
16281988|NCT00776984|Drug|tiotropium 5mcg/day|Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
16281989|NCT00776984|Drug|placebo|Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
16281990|NCT00776971|Other|Sugar-sweetened soft drink|500mL as a preload drink
16281991|NCT00776971|Other|Aspartame-sweetened soft drink|500mL as a preload drink
16281992|NCT00776971|Other|Semi-skimmed milk|500mL as a preload drink
16281993|NCT00776971|Other|Water|500mL as a preload drink
16281994|NCT00776958|Other|Questionnaire|Information Collection for Entry into Multicenter Registry: Survey 5-10 minutes. Participation lasts as long as patient agrees to continue having study information collected
16281995|NCT00776919|Drug|clindamycin / benzoyl peroxide gel|Once a day application to the face
16281996|NCT00776919|Drug|clindamycin gel|Once a day application to the face
16281997|NCT00776919|Drug|BPO gel|Once a day application to the face
16281998|NCT00776919|Drug|vehicle gel|Once a day application to the face
16281999|NCT00776906|Device|Advance® 18PTX® Balloon Catheter|
16282000|NCT00776906|Device|Advance® 18LP Balloon Catheter|
16282001|NCT00776880|Other|ASA scale|ASA scale evaluation before operation
16282002|NCT00776880|Other|PPS scale|PPS scale evaluation before operation
16282040|NCT00776568|Drug|Anti-hypertensive drugs|ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.
16282091|NCT00776035|Procedure|VO2 peak test|walking on a treadmill during which you will breath in and out through a tube
16282003|NCT00776867|Drug|perifosine|Open label, phase I study of oral perifosine in recurrent/progressive pediatric solid tumors. This will be a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3-6 patients at each dose level. All patients will receive perifosine at a loading dose on the first day, followed by a maintenance dose to start on day two until progression each patient will be assigned to a dosing group based on one's body surface area (BSA).
16282004|NCT00776854|Device|Noveon laser|870 and 930nm wavelengths
16282005|NCT00776841|Drug|Aramchol|1.Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B)
16282006|NCT00776841|Drug|Aramchol|Oral Aramchol at dose 30 mg to 900 mg
16282007|NCT00776841|Drug|Aramchol|Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days
16282008|NCT00776828|Drug|cilostazol|Pletaal (Otsuka Pharm.) 100mg bid for six months
16282009|NCT00776802|Drug|GCS-100|GCS-100 80 mg/m2 IV (in the vein) on Study Days 1, 2, 3, 4, and 5 of a 21-day course. Three or up to six patients will be enrolled in each cohort until the maximum tolerated dose is reached. The dose levels: 1) 80 mg/m2; 2) 120 mg/m2; 3) 160 mg/m2
16282010|NCT00776802|Drug|Etoposide; Dexamethasone|Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.
16282011|NCT00776789|Other|skin to skin contact|Infants randomized to SSC group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. breastfeeding at the time of discharge.
16282012|NCT00776789|Other|Control group|The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.
16282013|NCT00776763|Drug|Avastin intravitreal injection|1,25 mg of Bevacizumab (Avastin) will be intravitreally injected 4 weeks interval in the proliferative retinopathies groups (exudative age related macular degeneration and proliferative diabetic retinopathy)
16282014|NCT00776750|Biological|trivalent split influenza vaccine|standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection
16282015|NCT00776724|Drug|Taxotere , Epirubicin|Taxotere 70 mg/m2 1hr iv infusion / Epirubicin 90 mg/m2 (TE) iv infusion on day 1.
16282016|NCT00776724|Drug|E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP|"Tau+ topo II+ ERCC1+ : Epi 45mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
~Tau+ topo II+ ERCC1- : Epi 45mg/m2 iv/ Cis 35mg/m2 24 hrs iv infusion day 1 and 8.
~Tau+ topo II- ERCC1+ : Vin 25mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
~Tau+ topo II- ERCC1- : Cis 35mg/m2 24 hrs infusion / Vin 25mg/m2 iv day 1 and 8.
~Tau- topo II+ ERCC1+ : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1.
~Tau- topo II+ ERCC1- : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1.
~Tau- topo II- ERCC1+ : Tax 35mg/m2 1hr infusion / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8.
~Tau- topo II- ERCC1- : Tax 35mg/m2 1hr infusion / Cis 35mg/m2 24 hrs infusion day 1 and 8."
16282017|NCT00776711|Drug|Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005|
16282018|NCT00776711|Drug|VRC-AViDNA036-00-VP|
16282019|NCT00776698|Drug|bevacizumab [Avastin]|7.5mg/kg every 3 weeks for 3 cycles (cohort 1) or 15mg/kg every 3 weeks for 3 cycles (cohort 2). Preferred dose every 3 weeks for 9 cycles (cohort 3).
16282020|NCT00776698|Drug|cisplatin|80mg/m2 iv every 3 weeks for 3 cycles
16282021|NCT00776698|Drug|etoposide|100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles
16282022|NCT00776685|Behavioral|Personality-targeted interventions|Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained teacher and co-facilitator
16282023|NCT00776672|Drug|Fosinopril 40mg Tablets|
16282024|NCT00776659|Other|Aromasin|Non-Interventional study design.
16282025|NCT00776646|Drug|hydrochlorothiazide 50 mg tablet|
16282026|NCT00776633|Drug|aspirin|6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
16282027|NCT00776633|Drug|clopidogrel|6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
16282028|NCT00776633|Drug|oral anticoagulation|
16282029|NCT00776620|Drug|Glimepiride 1mg Tablets|
16282030|NCT00776607|Drug|NovoMix 30|Insulin arm: Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. Dose will be adjusted in increments of 2-6U depending on fasting glucose level When total dose equals 16 U patient will be started on 4 units with breakfast and continue with 16 units with evening meal. Breakfast and/or evening meal dose will be adjusted where necessary at increments of 2-6 U depending on fasting and/or pre-evening meal glucose level. Patient needs to keep a daily diary of insulin doses taken.
16282031|NCT00776607|Drug|Tablet treatment|Step 1: Lifestyle modification. If HbA1c at 7%+ or if on metformin/sulphonylurea go to step 2. Step 2: Glucophage. If HbA1c of 7%-7.5% give 500mg x 1 per day. If HbA1c 7.6%-8.0%, week 1 - 500mg x 1 day and then 500mg x 2 day. If HbA1c 8.0%+ then 500mg x 3 per day (Titrated). If HbA1c remains 7%+ give additional tablet until 2gms per day then progress to Step 3. Step 3: Rosiglitazone. HbA1c of 7%+ give 4 mg per day. If HbA1c remains 7%+ titrate to maximal dose 4 mg twice daily +/-Metformin. If HbA1c remains 7% + for an 3 months move to step 4. Before initiation of Rosiglitazone repeat medical history with special emphasis on cardiovascular disease, if patient has a history of CVD move to Step 4 (insulin). Any adverse events suggestive of heart disease move to step 4. Step 4: Insulin (oral agents will be stopped). Initiation of insulin will the same as for the insulin arm and will follow the protocol detailed in the Insulin arm.
16282032|NCT00776594|Drug|Androgen Deprivation Therapy|leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
16282033|NCT00776594|Drug|bicalutamide|50mg orally daily for 6 months
16282034|NCT00776594|Drug|bevacizumab|15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
16282035|NCT00776581|Procedure|CSEA with PCA|Records regarding combined spinal-epidural analgesia with patient-controlled pump
16282036|NCT00776581|Procedure|CSEA with IBI|Records regarding combined spinal-epidural analgesia with intermittent bolus injection
16282037|NCT00776581|Procedure|EA with PCA|Records regarding epidural analgesia with patient-controlled pump
16282038|NCT00776581|Procedure|EA with IBI|Records regarding epidural analgesia with intermittent bolus injection
16282041|NCT00776555|Drug|Lisdexamfetamine Dimesylate|Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit.
16282042|NCT00776555|Drug|Racemic mixture of dextroamphetamine and lisdexamfetamine|Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.
16282043|NCT00776542|Drug|Minocycline 100mg Tablets|
16282044|NCT00776529|Other|Sensorimotor training first, followed by strength exercises|nine sessions of one hour duration
16282045|NCT00776529|Other|Strength exercises and sensorimotor exercises alternated|nine sessions of one hour
16282046|NCT00776516|Drug|mirabegron|oral
16282047|NCT00776516|Drug|rifampin|oral
16282048|NCT00776503|Drug|VORINOSTAT|vorinostat; 400mg once daily; increasing duration (7-10-14 days)
16282049|NCT00776490|Drug|Glimepiride 1mg Tablets|
16282050|NCT00776477|Drug|clopidogrel and aspirin|clopidogrel 75mg daily and aspirin 100mg daily
16282051|NCT00776477|Drug|aspirin|aspirin 100mg daily
16282052|NCT00776464|Device|Noveon laser|Two wavelenghts of light
16282053|NCT00776438|Biological|Inactivated, split-virion, influenza vaccine|0.1 mL, Intradermal
16282054|NCT00776438|Biological|Inactivated, split-virion, influenza vaccine|0.5 mL, Intramuscular
16282055|NCT00776438|Biological|Inactivated, split-virion influenza vaccine|0.1 mL, Intradermal
16282056|NCT00776438|Biological|Inactivated, split-virion influenza vaccine|0.5 mL, Intramuscular
16282057|NCT00776425|Drug|Epoetin beta|Epoetin beta subcutaneously or intravenously at a dose of 150 IU per kg of body weight thrice weekly or 30000 IU once weekly.
16282058|NCT00776399|Device|Lung radiofrequency ablation|A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
16282059|NCT00776373|Drug|Rapamycin + high dose etoposide and cytarabine|Rapamycin,by mouth, loading dose followed by a single daily dose for 8 days (dose level 1 = load of 9 mg followed by 3 mg daily doses, dose level 2 = 12 mg with daily doses of 4 mg; Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.
16282060|NCT00776360|Drug|oxytocin|80mIE/min as continuous infusion for 70 minutes
16282061|NCT00776360|Drug|oxytocin|80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
16282062|NCT00776347|Drug|Donepezil|Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
16282063|NCT00776347|Drug|Donepezil|
16282064|NCT00776334|Drug|Fosinopril 40mg Tablets|
16282065|NCT00776321|Drug|Eprotirome|
16282066|NCT00776321|Drug|Placebo|
16282067|NCT00776295|Biological|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes|Autologous Dendritic Cells Derived from Peripheral Blood Mononuclear Cells, Cultured with Granulocyte-Macrophage Colony-Stimulating Factor and Interleukin 4, Transfected with Adenovirus Vector (Ad5CMV-p53, Introgen Therapeutics) Expressing Wildtype p53 Gene; Combined with Autologous Expanded T Lymphocytes (CD3+, CD4+, and CD8+), Cultured with OKT3 (Orthoclone) and Anti-CD28 (Repligen) Coated Magnetic Beads
16282068|NCT00776282|Drug|loratadine 10 mg orally disintegrating|
16282069|NCT00776269|Procedure|argon laser and radiofrequency|
16282070|NCT00776256|Dietary Supplement|beta-glucan and fructooligosaccharide|1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
16282071|NCT00776230|Biological|IC51|6 mcg im. at day 0 and day 28
16282072|NCT00776217|Drug|loratadine 10 mg orally disintegrating tablets|
16282073|NCT00776204|Device|JACTAX Drug eluting stent|Jactax stent placed in coronary artery
16282074|NCT00776204|Device|JACTAX LD drug eluting stent|JACTAX LD stent placed in coronary artery
16282075|NCT00776204|Device|Taxus Libertè|Taxus Libertè stent placed in coronary artery
16282076|NCT00776191|Drug|Physioneal 35|Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
16282077|NCT00776191|Drug|Physioneal 40|Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks
16282078|NCT00776165|Biological|Recombinant Human GCSF (Shantha Biotechnics Limited)|Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
16282079|NCT00776165|Biological|Neupogen|Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
16282080|NCT00776139|Drug|Cetirizine Hydrochloride 10 mg tablet|Bioequivalence Cetirizine Hydrochloride 10 mg tablet
16282081|NCT00776126|Device|Digital Breast Tomosynthesis Exam|Digital Breast Tomosynthesis Exam consisting of single view (MLO) of each breast will be performed.
16282082|NCT00776113|Drug|Carvedilol 12.5 mg tablets|bioequivalence Carvedilol fasting
16282083|NCT00776100|Other|clinical observation|Patients undergo observation for 6 weeks.
16282084|NCT00776100|Radiation|radiation therapy|Patients undergo radiotherapy 5 days a week for 6 weeks.
16282085|NCT00776087|Device|Home Monitoring provided by Biotronik ICD and CRT-D devices|Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety
16282086|NCT00776087|Device|No Home Monitoring|Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).
16282087|NCT00776074|Drug|Leuprorelin (GF)|Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16282088|NCT00776074|Drug|Leuprorelin (GC)|Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16282089|NCT00776035|Procedure|PET (positron Emission Tomography)|this is a diagnostic scan that requires the injection of radioactive tracers into an IV placed in the arm.
16282092|NCT00776035|Procedure|Body composition Study|a scan of your entire body measuring Body Mass Index, fat percentage etc...
16282093|NCT00776035|Radiation|15O water|radioactive tracer used to study blood flow during the PET scan
16282094|NCT00776035|Radiation|11C Acetate|radioactive tracer that helps study heart metabolism
16282095|NCT00776035|Radiation|11C Palmitate|radioactive tracer used to study fatty acid usage in the heart
16282096|NCT00776035|Radiation|11C Glucose|radioactive tracer usde to study glucose usage in the heart
16282097|NCT00776022|Drug|Cetirizine Hydrochloride 10 mg tablet|Bioequivalence Cetirizine Hydrochloride 10 mg tablet fed conditions
16282098|NCT00776009|Drug|Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)|10 mg and/or 20 mg capsules
16282099|NCT00776009|Drug|Placebo|Placebo Comparator
16282100|NCT00775996|Drug|Clorazepate Dipotassium 15mg Tablets|
16282101|NCT00775983|Device|laminaria|place device in cervix for dilation
16282102|NCT00775983|Device|Dilapan-S|Place in cervix for dilation.
16282103|NCT00775970|Behavioral|walking activity|
16282104|NCT00775957|Procedure|FLT-PET scan|imaging scan
16282105|NCT00775957|Procedure|FDG-PET scan|imaging scan
16282106|NCT00775944|Behavioral|Proactive telephone support|Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
16282107|NCT00775944|Behavioral|Reactive (standard) telephone support|Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
16282108|NCT00775944|Drug|Offer of voucher for cost-free Nicotine Replacement Therapy|Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
16282109|NCT00775931|Procedure|umbilical cord blood transplantation|Umbilical cord blood will be collected, processed and shipped according to existing protocols. 2 cord blood units will be utilized if available. The choice of units will be based on the HLA typing standards of the University of Minnesota Blood and Marrow Program. If 2 units are not available, a single unit may be used. If a single unit is used, the unit should provide at least 10 x 107 nucleated cells/kg recipient body weight.
16282110|NCT00775931|Drug|Campath-1H|Campath-1H will be administered 0.3 mg/kg subcutaneously per day for three days starting on Day -21 through Day -19.
16282111|NCT00775931|Radiation|Total Lymphoid Irradiation|Dose 500 cGy via anteroposterior (AP) and posteroanterior(PA) fields (250 cGy AP and 250 cGy PA).
16282112|NCT00775931|Drug|Cyclophosphamide|Cyclophosphamide (50 mg/kg/dose) will be given IV on day -4, -3, -2 and -1 over 2 hours. The total dose to be given over 4 days is 200 mg/kg for cord blood grafts-receiving patients only.
16282113|NCT00775931|Drug|Busulfan|patients<12 kg: 1.1 mg/kg/dose IV every 6 hours for 8 doses total; patients >12 kg: 0.8 mg/kg/dose IV every 6 hours for 8 doses. on Day -8 to -7 for donor grafts-receiving patients, and on Day -9 to -6 for cord blood grafts-receiving patients.
16282114|NCT00775931|Drug|Fludarabine monophosphate|Fludarabine (35 mg/m2 daily for 5 days, 175 mg/m2 total) will be administered IV over 30 minutes on days -6, -5, -4, -3, and -2 for donor grafts-receiving patients only.
16282115|NCT00775931|Procedure|marrow graft transplantation|Related donor marrow will be collected, processed and shipped according to existing protocols of the National Marrow Donor Program or other URD registry, with the goal of achieving a cell dose of ≥ 6.0 x 108 nucleated cells/kg. The proportion of cells that are CD34+ will be determined prior to the administration of the graft. This will allow a portion of the graft (2 x 106 CD34+ cells) to be frozen for a subsequent infusion on day +42.
16282116|NCT00775918|Drug|Doxycycline monohydrate 100mg tablets|Bioequiavelnce Doxycycline monohydrate 100mg tablets fed conditions
16282117|NCT00775905|Drug|amlodipine 10 mg tablet|
16282118|NCT00775892|Device|SeriACL Device ACL Reconstruction|Long-term Bioresorbable ACL Scaffold
16282119|NCT00775879|Drug|Induction with Sevoflurane|
16282120|NCT00775866|Procedure|MRI-Guided Biopsy|Technical development and clinical testing of a novel technique for magnetic resonance imaging (MRI) guided prostate biopsy in a 1.5T horizontal bore scanner using a dedicated interventional table.
16282121|NCT00775840|Drug|Candesartan|Candesartan up to 32 mg, tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
16282122|NCT00775840|Drug|Placebo|Candesartan matching-placebo tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
16282123|NCT00775827|Drug|fenofibrate 160 mg tablets|
16282124|NCT00775814|Drug|Candesartan and Hydrochlorothiazide|Candesartan 8 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for 2 weeks; increased to Candesartan 16 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.
16282125|NCT00775814|Drug|Hydrochlorothiazide (HCT)|Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.
16282126|NCT00775801|Device|FLD|Artificial lumbar disc
16282127|NCT00775801|Device|Control|Artificial lumbar disc
16282128|NCT00775788|Procedure|Autologous Fat Grafting to Breasts|Fat injection of Fat to breasts
16282129|NCT00775762|Drug|aspirin|Aspirin (75-100 mg)die for three months
16282130|NCT00775762|Drug|clopidogrel|Clopidogrel (75mg) die for three months
16282131|NCT00775762|Drug|clopidogrel plus aspirin|clopidogrel 75 mg die plus aspirin 75-100 mg for three months
16282132|NCT00775749|Drug|transdermal nicotine patch|The 7 mg transdermal nicotine patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.
16282133|NCT00775749|Drug|placebo patch|The placebo patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.
16282134|NCT00775736|Drug|biphasic insulin aspart 30|Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
16282135|NCT00775736|Drug|biphasic insulin aspart 50|Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
16282136|NCT00775736|Drug|biphasic insulin aspart 70|Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
16282137|NCT00775710|Device|Nocturnal non-invasive ventilation|Prolongation of non-invasive ventilation during 3 nights.
16282138|NCT00775697|Drug|Montelukast|the arm will be treated with Montelukast 4 mg die for 4 weeks
16282139|NCT00775697|Drug|Montelukast|montelukast 4 mg day for 4 weeks
16282140|NCT00775684|Drug|Exenatide|Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects
16282141|NCT00775684|Drug|Sitagliptin|Sitagliptin (Januvia®)100 mg by mouth every morning
16282142|NCT00775684|Drug|Glimepiride|Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl
16282143|NCT00775671|Drug|placebo|Placebo pill by mouth daily for 21 days followed by either Nebivolol 5 mg by mouth daily or metoprolol ER 100mg by mouth daily for 12 weeks.
16282144|NCT00775671|Drug|Nebivolol|Nebivolol 5 mg by mouth daily for 12 weeks.
16282145|NCT00775671|Drug|Metoprolol|Metoprolol ER 100mg by mouth daily for 12 weeks.
16282146|NCT00775658|Drug|olopatadine|olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
16282147|NCT00775658|Drug|placebo|placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
16282148|NCT00775645|Dietary Supplement|acetyl-L-carnitine hydrochloride|Given orally
16282149|NCT00775645|Other|placebo|Given orally
16282150|NCT00775632|Drug|Alemtuzumab|A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.
16282151|NCT00775632|Drug|mycophenolate or cyclosporine and methotrexate|One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
16282152|NCT00775619|Drug|Carvedilol 12.5 mg tablets|bioequivalence Carvedilol 12.5 mg tablets fed conditions
16282153|NCT00775606|Drug|Lopinavir 400 mg/ritonavir 100 mg|Lopinavir 400 mg/ritonavir 100 mg fixed dose combination BID + emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD
16282154|NCT00775606|Drug|Efavirenz|Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD
16282155|NCT00775593|Drug|clofarabine|"Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction.
~Induction therapy
~- Clofarabine 20 mg/m2/day, administered by iv infusion over 1 hour on days 1 through 5"
16282156|NCT00775593|Drug|temsirolimus|"Those who achieve morphologic CR and morphologic CRi will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse.
~Those who achieve a PR will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above.
~Induction therapy:
~- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1, 8 and 15.
~Maintenance therapy:
~- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1 and 8 of each month for 12 months, or until relapse."
16282157|NCT00775580|Drug|Atenolol 100mg Tablets|
16282158|NCT00775567|Dietary Supplement|Fructose powder|30g in 250ml water twice a day
16282159|NCT00775554|Other|ultrasound guided hematoma block|pt. will receive ultrasound guided hematoma block
16282160|NCT00775554|Other|ultrasound guided hematoma block|ultrasound will be used to guide hematoma blocks
16282161|NCT00775541|Dietary Supplement|Vitamin C|One IV infusion of 2 gm vitamin C
16282162|NCT00775528|Drug|Pancrelipase Delayed Release|3,000, 6,000 and 12,000 unit Lipase Capsules
16282163|NCT00775515|Procedure|laparoscopic prostatectomy|laparoscopic prostatectomy
16282164|NCT00775502|Drug|BIW-8962|Intravenous administration of liquid dosage form. Doses 0.03, 0.10, 0.30, 1.0, 3.0, and 10 mg/kg. Frequency is once every two weeks. Duration is 6 months
16282165|NCT00775489|Drug|Nasal steroid Beclomethasone|Beclomethasone nasal steroids to be given to a very well controlled glaucoma patients to find if this normal dose will lead to increase in intraocular pressure up to 20% where the study will be stopped at this point.
16282166|NCT00775489|Drug|Saline|control group will receive normal saline inhaler
16282167|NCT00775476|Drug|N-acetylcysteine|Capsules of NAC, each containing 600 mg of NAC between dosages of 2.4 g to 4.8 g daily
16282168|NCT00775476|Drug|Placebo|placebo (sugar) twice daily, daily dosage will match that of NAC that was tolerated between daily dosages of 2.4 g and 4.8 g during the open-label titration phase.
16282169|NCT00775463|Drug|treprostinil diethanolamine|oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID)
16282170|NCT00775463|Drug|placebo|
16282171|NCT00775450|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16282172|NCT00775450|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16282173|NCT00775450|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16282174|NCT00775450|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16282175|NCT00775450|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16282176|NCT00775437|Drug|Adalimumab|Adalimumab solution for injection for subcutaneous use.
16282177|NCT00775424|Biological|PENNVAX-B|PENNVAX-B is a cocktail of three expression plasmids. The plasmids include the genes which encode a synthetic HIV-1 envelope protein (pEY2E1-B), Gag (gagCAM02), and Pol (pK2C1). Each plasmid is manufactured to a concentration of 4.0 mg/mL and is formulated with bupivacaine (0.25%) as a facilitating agent for DNA uptake. All plasmids (2.0 mg each gag, pol, env) are premixed by the manufacturer in the same vial.
16282178|NCT00775424|Biological|GENEVAX IL-12-4532|GENEVAX IL-12-4532 This molecular adjuvant plasmid contains nucleotide sequences necessary for expression of the human IL-12 protein. IL-12 DNA is formulated at a concentration of 2.0 mg/mL with bupivacaine (0.25%).
16282179|NCT00775424|Biological|PLACEBO|PLACEBO
16282180|NCT00775424|Biological|IL-15 adjuvant|pIL15EAM is a plasmid that encodes human IL-15 and has been optimized to express 87 fold higher than native IL-15 DNA and 5.7 fold higher than an earlier generation optimized IL-15 DNA construct. This plasmid is formulated at a concentration of 4.0 mg/mL with bupivacaine (0.25%).
16282181|NCT00775411|Drug|dexamethasone|700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
16282182|NCT00775411|Biological|ranibizumab|Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
16282183|NCT00775385|Drug|Standard Chemotherapy|Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
16282184|NCT00775385|Drug|Customized Treatment|"Mutated EGFR : Erlotinib 150mg/day (1 year)
~Wild-type EGFR or undetermined depends on ERCC1 status :
~ERCC1 high : no treatment
~ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)"
16282185|NCT00775372|Drug|Clarithromycin 250mg/5mL|
16282186|NCT00775359|Drug|Fenofibrate 160 mg tablets|
16282187|NCT00775333|Procedure|Outcome after carpal tunnel release|Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients
16282188|NCT00775320|Procedure|FLT-PET scan|Imaging test
16282189|NCT00775307|Drug|PAZOPANIB|400 mg/day (24 weeks)
16282190|NCT00775307|Drug|Placebo|Placebo 400 mg/day (24 weeks)
16282191|NCT00775294|Drug|Maraviroc|Healthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days)
16282192|NCT00775268|Procedure|Biopsy|Biopsy taken
16282193|NCT00775268|Diagnostic Test|fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography|Imaging
16282194|NCT00775268|Other|[3'-deoxy-3'-[F-18] fluorothymidine|Undergo scans
16282195|NCT00775268|Procedure|computed tomography|Undergo scans
16282196|NCT00775268|Procedure|fine-needle aspiration|sample collected
16282197|NCT00775255|Drug|clarithromycin 250 mg/5 mL powder for oral suspension|
16282198|NCT00775242|Drug|Estradiol and Progesterone|Injectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period.
16282199|NCT00775242|Drug|Estradiol and Progesterone|Injectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period
16282200|NCT00775229|Drug|Naltrexone|pill, by mouth, 50mg-150mg/day for the duration of the study
16282201|NCT00775229|Drug|Placebo|pill, by mouth, daily
16282202|NCT00775216|Behavioral|"Behavioral counseling plus telephone helpline"|A trained behavioral counselor will place phone calls to Phase 2 intervention participants. These calls will be used to provide tailored physical activity advice and to extend our partnership with the Metro Nashville Parks and Recreation Department, directing participants to community centers close to their homes or workplaces where they can access a variety of physical activities (e.g., indoor pools, walking tracks, fitness centers, greenways, etc) using a newly developed electronic database. Following an orientation to the Metro Parks services which will be held at either Hadley Regional Park or Coleman Regional Park, participants will be directed to the Metro Parks facility most convenient to them.
16282203|NCT00775203|Drug|Trazodone Hydrochloride (HCl) Extended-Release Tablets|
16282204|NCT00775203|Drug|Placebo|
16282205|NCT00775190|Drug|ortho tricyclen|brand name oral contraceptive
16282206|NCT00775190|Drug|Trinessa|generic oral contraceptive
16282207|NCT00775177|Drug|Doxycycline monohydrate 100mg tablets|Bioequivalence Doxycycline monohydrate 100mg tablets fasting condition
16282208|NCT00775164|Drug|pioglitazone|15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks
16282209|NCT00775164|Drug|Metformin|Metformin XR; 1000 mg once daily
16282210|NCT00775151|Drug|amlodipine 10 mg tablet|
16282211|NCT00775138|Drug|280 mg Arikayce™|Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16282212|NCT00775138|Drug|Matching Placebo for Cohort 1|Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16282213|NCT00775138|Drug|560 mg Arikayce™|Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16282214|NCT00775138|Drug|Matching Placebo for Cohort 2|Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16282215|NCT00775125|Drug|Telaprevir; Darunavir; Ritonavir; Fosamprenavir|
16282216|NCT00775112|Device|pillow|use of pillow for lumbar punctures
16282217|NCT00775099|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
16282218|NCT00775099|Procedure|Badimon Chamber|Ex-vivo assessment of thrombus formation using Badimon Chamber
16282219|NCT00775086|Drug|norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.|
16282220|NCT00775073|Drug|Everolimus, Bevacizumab|Everolimus 5 mg tablet per day orally. Bevazicumab 5 mg per kg intravenous every 2 weeks.
16282221|NCT00775047|Other|Pharmacist-administered|women will receive their injections at a pharmacy by a clinical pharmacist
16282222|NCT00775047|Other|clinic-administered injections|women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.
16282223|NCT00775034|Drug|Tisseel®|Mesh repair for open incisional hernia repair with fibrin sealant
16282224|NCT00775034|Procedure|Drainage|Mesh repair for open incisional hernia repair with drainage
16282225|NCT00775021|Device|etafilcon A|Contact Lens
16282226|NCT00775021|Device|nelfilcon A|Contact Lens
16282227|NCT00775008|Behavioral|electronic health information|Participants will receive weight loss information via 1 of 2 different mediums.
16282228|NCT00774995|Biological|EngerixTM-B|Intramuscular injection, one dose.
16282229|NCT00774982|Drug|Delayed Release 6 mercaptopurine|oral tablet, 1 x 40 mg Delayed Release 6MP tablet, single-dose
16282230|NCT00774982|Drug|6 Mercaptopurine|Oral Tablet, 2 x 50 mg 6MP Reference, single-dose
16282231|NCT00774969|Drug|Metronidazole|Metronidazole 10% ointment three times a day 7 days
16282232|NCT00774956|Procedure|Exercise training program|A 6 week shoulder exercise training program
16282233|NCT00774956|Procedure|Exercise training program|A 6 week shoulder exercise training program
16282234|NCT00774943|Drug|AMG 557|A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.
16282235|NCT00774930|Drug|Lanreotide|deep s.c. injection, 120 mg, every 4 weeks (±3 days).
16282312|NCT00774384|Biological|NZ MenB OMV vaccine (NZ98/254)|3 doses by intramuscular injection
16282236|NCT00774930|Drug|Placebo|deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).
16282237|NCT00774917|Device|Numen|Numen Co-Cr coronary stent implant
16282238|NCT00774904|Drug|Losartan|Angiotensin II Type 1 Receptor Blockers
16282239|NCT00774878|Drug|AVE1642|AVE1642 is administered intravenously at the dose of 8 mg/kg.
16282240|NCT00774878|Drug|Fulvestrant|Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).
16282241|NCT00774865|Procedure|MIBI and CTA|Rest and Stress MIBI and CT Angiography
16282242|NCT00774852|Drug|abatacept|Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
16282243|NCT00774852|Drug|cyclophosphamide|500 mg intravenous infusion every 2 weeks for 12 weeks
16282244|NCT00774852|Drug|azathioprine|2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24
16282245|NCT00774852|Drug|prednisone|60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose
16282246|NCT00774852|Drug|abatacept placebo|Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
16282247|NCT00774852|Drug|azathioprine placebo|Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24
16282248|NCT00774839|Behavioral|Patient Interview|The patient will participate in a semistructured interview conducted by a trained staff member and designed to last approximately 45 minutes. All interviews will take place at least 4 months into or up to 7 months after the end of the treatment, if possible and will be scheduled to occur at the time of the chemotherapy infusion, or at another time at the care facility when it is convenient for the patient. If the patient is not scheduled or chooses not to be at the care facility within a time frame that fits the study parameters, the patient may opt to be interviewed at another location, including the patient's home.
16282249|NCT00774826|Drug|R-CVP|Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
16282250|NCT00774826|Drug|R-CHOP|Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
16282251|NCT00774826|Drug|R-FM|Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
16282252|NCT00774813|Device|Nexalin 1.3mA Device|"3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
~Daily receipt of placebo antidepressant"
16282253|NCT00774813|Device|Nexalin 15mA device|"3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
~Daily receipt of a placebo antidepressant"
16282254|NCT00774813|Drug|placebo device and Citalopram|"3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
~Daily receipt of a a SSRI (Citalopram or similar)"
16282255|NCT00774800|Drug|Humalog|
16282256|NCT00774800|Drug|Humulin-R|
16282257|NCT00774800|Drug|Recombinant human hyaluronidase PH20 (rHuPH20)|
16282258|NCT00774800|Other|Liquid meal|
16282259|NCT00774787|Drug|imiquimod 5% cream|1 packet (250 mg cream) 3 times per week for 4 weeks
16282260|NCT00774774|Device|control|"Non sterile surgical mask,high filtration AEROKYN,type 2 with eardrop"
16282261|NCT00774774|Device|Face mask|"Non sterile surgical mask, high filtration AEROKYN, type 2 with eardrop Masks will be worn at home by the patient over a period of 5 days following inclusion, whenever a member of the household will attend the same room or in other confined space (eg car), and changed after 3 hours of consecutive use or sooner if they are tor
~Masks will not be worn:
~during the night,
~when the patient is alone in the room. Moreover, for all households, an incentive in nocturnal isolation of index-patient will be recommended"
16282262|NCT00774761|Drug|fluticasone propionate/formoterol fumarate|inhalation suspension
16282263|NCT00774761|Drug|fluticasone propionate|inhalation suspension
16282264|NCT00774761|Drug|formoterol fumarate|inhalation solution
16282265|NCT00774748|Device|Insuflon|Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.
16282266|NCT00774735|Drug|GSK1349572|30 mg given in combination with lopinavir/ritonavir
16282267|NCT00774735|Drug|GSK1349572|30 mg in combination with darunavir/ritonavir
16282268|NCT00774722|Drug|Metronidazole|10% ointment, three times daily for 14 days
16282269|NCT00774696|Drug|clarithromycin 500mg tablets|
16282270|NCT00774683|Drug|Raltegravir (Isentress®)|400 mg p.o. BID x 7 days
16282271|NCT00774644|Drug|Clarithromycin 500mg|
16282272|NCT00774631|Procedure|Mild induced hypothermia (32-34°C)|"Mild Induced hypothermia:
~Investigators are advised to use the cooling techniques as used in patients with cardiac arrest. Thus, the choice of cooling method will be left to investigators. Hypothermia will be induced by cold saline infusion as described in appendix 5 [6, 48]. Core temperature will be monitored by oesophageal probe and maintained between 32°C and 34°C during 48 hours and followed by strictly passive rewarming. During this phase of treatment, patients will receive deep sedation associated with neuromuscular blockers. Centers participating to the trial will have expertise in cooling methods."
16282273|NCT00774631|Procedure|local recommendations and guidelines|"Investigational procedure:
~This study evaluates the impact of mild induced hypothermia (32-34°C) during 48 hours followed by passive rewarming according to recommendations described in appendix. All treatment will be according to local recommendations and guidelines of medical societies and literature. Physicians are advised to use these recommendations; however, the best treatment option for the individual patient should be used.
~Controls will receive standard care and will be also be deeply sedated for 48 hours."
16282349|NCT00774098|Drug|Intravenous normal saline (NS 0.9)|Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output
16282350|NCT00774085|Other|No intervention was given|Participants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians
16282351|NCT00774072|Drug|Tobramycin (Gernebcin®)|1 ml / day in each nostril
16282352|NCT00774059|Device|Breast lift system|During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast
16282274|NCT00774618|Device|Resection with or without plate fixation|Some enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients.
16282275|NCT00774605|Drug|Varenicline free base solution|A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period
16282276|NCT00774605|Drug|Varenicline free base patch|A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period
16282277|NCT00774592|Behavioral|FOYC|FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
16282278|NCT00774592|Behavioral|Goal for it (GFI)|GFI is a one-session parent intervention consisting of a 20-minute video followed by a discussion regarding the process of setting and reaching goals.
16282279|NCT00774592|Behavioral|Wonderous Wetlands|Wonderous Wetlands is an eight-session, group intervention for youth. It includes field projects and discussions based on ways to save our environment.
16282280|NCT00774592|Behavioral|Caribbean Informed Parents and Children Together (CImPACT)|CImPACT is a parent intervention addressing parental monitoring and communication with youth. It consists of a 20-minute video, a condom practice, and role play simulating a parent-child discussion.
16282281|NCT00774592|Behavioral|Bahamian Focus on Older Youth (BFOOY)|10 session HIV prevention program
16282282|NCT00774592|Behavioral|Health and Family Life Curriculum (HFLE)|Standard Grade 10 curriculum
16282283|NCT00774566|Procedure|PV-Isolation RF|Radiofrequency
16282284|NCT00774566|Procedure|PV-Isolation Cryo|Cryo-Balloon
16282285|NCT00774553|Drug|AZD1656|Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
16282286|NCT00774553|Drug|Placebo|Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
16282287|NCT00774540|Drug|1 Ketorolac intraarticular|Ketorolac intraarticular 5 mg
16282288|NCT00774540|Drug|Placebo|Saline
16282289|NCT00774527|Drug|Cyclophosphamide-fludarabine-anti thymocyte globulin|"Cyclophosphamide 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter.
~Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days -6 to -2).
~Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2."
16282290|NCT00774514|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of vasodilators Acetylcholine (5-20 mg/min), sodium nitroprusside (2-8 µg/min), bradykinin (100-1000 pmol/min) and verapamil (10-100 µg/min)
16282291|NCT00774501|Procedure|image guidance with general anesthesia and suspended ventilation during treatment delivery|"All study patients will undergo marker implantation approximately 2 weeks prior to the PET-CT simulation and treatment planning. PET-CT is performed for treatment planning purposes. This part of the process is in routine clinical use at MSKCC.
~Three cone beam imaging scans and an IV contrast injection just prior to the first cone beam scan will be added to the standard procedure. The use of these two techniques is investigational.
~The treatment delivery will make use of general anesthesia and suspension of mechanical ventilation to render the patient apneic during both target localization and dose delivery. This will allow the dose to be delivered more precisely than the techniques currently in use, thus allowing the use of smaller treatment margins and reducing the high dose exposure of healthy liver tissue. These measures have not previously been used for treatment delivery."
16282292|NCT00774488|Other|Glucose dependent insulinotropic polypeptide (GIP)|GIP-Infusions for 4 h in a postprandial concentration
16282293|NCT00774475|Drug|comparison of different dosage of clopidogrel|clopidogrel 75 mg/day versus clopidogrel 150 mg/day
16282294|NCT00774475|Drug|doubled therapy|clopidogrel 150 mg/day
16282295|NCT00774462|Drug|Rituximab|Rituximab 1000 mg intravenous, 2 times, 2 weeks apart and 1000 mg 6 months after the last injection
16282296|NCT00774436|Procedure|focal cryotherapy|Those men meeting the re-staging biopsy criteria will subsequently be treated with focal cryotherapy. Clinical follow-up visits will be scheduled at 6 + 2 weeks, 3 + 1 months and 6 + 1 months after focal cryotherapy, at which time, a digital rectal examination and PSA test will be performed. Standard quality-of-life questionnaires, are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).
16282297|NCT00774423|Drug|Riluzole|50 mg per day during 24 months
16282298|NCT00774397|Drug|BI 201335 NA 240 mg QD / LI|240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks
16282299|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
16282300|NCT00774397|Drug|BI 201335 NA 120mg QD / LI|120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks
16282301|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
16282302|NCT00774397|Drug|BI 201335 NA 240 mg QD|240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
16282303|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
16282304|NCT00774397|Drug|BI 201335 NA 240 mg QD|240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
16282305|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
16282306|NCT00774397|Drug|BI 201335 NA 240 mg BID|240mg BI 201335 NA (Faldaprevir) twice, 24 weeks
16282307|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
16282308|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
16282309|NCT00774397|Drug|BI 201335 NA 240 mg QD|240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
16282310|NCT00774397|Drug|PegIFN/RBV|PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
16282311|NCT00774397|Drug|Placebo|Placebo
16282434|NCT00773422|Drug|placebo|placebo
16282313|NCT00774371|Behavioral|Cognitive behavioral therapy CBT) for weight loss|The intervention program emphasizes regular physical activity, healthy eating, and psychological components within the structure of CBT for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity and strength training. A deficit of 500-1000 kcal/day is the recommended level of dietary modification to promote weight loss and maintenance. Group sessions are held weekly for 4 months, every other week for two months, and monthly sessions through 18 months. Data are collected at baseline, 6 months, and 18 months. Wait-list group subjects will receive general contact without specific reference to weight management topics through a 24-month period of data collection and will then be provided intervention materials in a seminar format.
16282314|NCT00774358|Drug|Interleukin-2|We propose to subcutaneously administer 0.5 MU/m2 of IL-2 daily to WAS subjects for 5 days. Research treatment will be repeated 2 and 4 months later. Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based on safety as the primary endpoint.
16282315|NCT00774345|Drug|Lenalidomide|Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
16282316|NCT00774345|Drug|Placebo|Placebo capsules given orally on days 1 - 28 of a 28 day cycle
16282317|NCT00774332|Drug|CODOX-M|Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine
16282318|NCT00774319|Radiation|conventional radiotherapy with 'high' dose cisplatin|"radiotherapy: 5 fractions/week, total treatment time 7 weeks. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions.
~100 mg/m2 cisplatin iv on day 1, 22 and 43"
16282319|NCT00774319|Radiation|accelerated radiotherapy with 'low' dose cisplatin|Accelerated radiotherapy 6 fractions/week, total treatment time 6 weeks. During one of the weekdays two fractions will be delivered with an interval of at least 6h. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions cisplatin 40 mg/m2 iv on day 1,8,18,22,29,35
16282320|NCT00774306|Drug|phenytoin|Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
16282321|NCT00774306|Drug|valproate|Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
16282322|NCT00774306|Drug|levetiracetam|Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
16282323|NCT00774293|Drug|placebo|5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
16282324|NCT00774293|Drug|Arnica and Bryonia|Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
16282325|NCT00774280|Drug|BuCy vs BuFlu|Arm 1:BuCy Arm 2:BuFlu
16282326|NCT00774267|Drug|BZA 20 mg/CE 0.45 mg|There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
16282327|NCT00774267|Drug|BZA 20 mg/CE 0.625 mg|There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
16282328|NCT00774267|Drug|Raloxifene 60 mg|There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
16282329|NCT00774267|Drug|Placebo|There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
16282330|NCT00774254|Behavioral|A|Intervention
16282331|NCT00774254|Behavioral|B|Intervention
16282332|NCT00774241|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
16282333|NCT00774241|Drug|docetaxel|75mg/m2 every 3 weeks for 18 weeks
16282334|NCT00774228|Device|I-ZIP Ocular Bandage|
16282335|NCT00774228|Device|Oasis 24 Hour Soft Shield Collagen Corneal Shield|
16282336|NCT00774202|Drug|Rituxan, Cyclophosphamide, Vincristine, Prednisone|'Rituximab, Cyclophosphamide, Vincristine, Prednisone interventions are as follows: Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once weekly, the first infusion will be given 5 days (± 3 days) prior to the first infusions of C and V and oral P, and the following 3 rituximab infusions will be given on the same day as the 3 cycles of C, V, and P.
16282337|NCT00774202|Drug|Higher Dose of Rituximab|rituximab 750mg/m2 (twice the standard dose of 375mg/m2) will be given weekly for 4 weeks. Premedication and infusion rate escalation will be exactly the same as for standard dose rituximab. The additional dose will thus run at 400ml/hr.
16282338|NCT00774189|Drug|clarithromycin 250 mg tablets|
16282339|NCT00774163|Biological|Lactobacillus reuteri|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
16282340|NCT00774163|Other|Placebo|5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
16282341|NCT00774150|Behavioral|Cognitive Behavioral Therapy|16 sessions of CBT
16282342|NCT00774150|Behavioral|Client Centered Therapy|16 sessions of CCT
16282343|NCT00774124|Other|telemonitoring|Women will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week
16282344|NCT00774124|Other|Standard of care|Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.
16282345|NCT00774111|Drug|GSK1349572|GSK1349572 50 mg in combination with Etravirine
16282346|NCT00774098|Drug|dextrose 10% (D10W ®) infusion|Started at 8pm the day before surgery until the procedure begins
16282347|NCT00774098|Drug|hyperinsulinemic normoglycemic clamp|Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively
16282348|NCT00774098|Dietary Supplement|high calorie diet 35 kcal/kg|High Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery
16282353|NCT00774046|Drug|Ara-C|"Induction: 3000mg/m2 IV infusion for day 1 and day 5
~Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total)"
16282354|NCT00774046|Drug|Mitoxantrone|Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
16282355|NCT00774046|Drug|Etoposide|Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
16282356|NCT00774033|Device|autologous epidermal cells harvesting kits|autologous epidermal cells harvesting kits used for the treatment of acute burn
16282357|NCT00774033|Procedure|classic skin grafts|classic skin grafts used for the treatment of acute burn
16282358|NCT00774020|Drug|Zoledronic acid|5mg, i.v. single dose
16282359|NCT00774007|Drug|mesalazine|
16282360|NCT00774007|Drug|placebo|
16282361|NCT00773994|Other|Normal Velopharyngeal Mechansim|The amount of radiation exposure that you will receive from this procedure is about 0.3 rem to the head and neck, with minimal exposure of the other body areas.
16282362|NCT00773981|Procedure|Transrectal vacuum assisted drainage|Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The principle of the method is application of negative pressure on the wound surface with the help of a sponge that is connected to a pump. Sponge dressings should be changed 3 times pr week as long as vacuum therapy is used. If there has been no development of granulation tissue or no shrinking of the cavity in 3 weeks Vacuum therapy can be stopped. Maximum vacuum therapy is 8 weeks.
16282363|NCT00773968|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
16282364|NCT00773955|Drug|R-(-)-gossypol acetic acid|Given orally
16282365|NCT00773955|Other|pharmacological study|Correlative studies
16282366|NCT00773955|Other|laboratory biomarker analysis|Correlative studies
16282367|NCT00773942|Behavioral|Basic medication therapy management|Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview alone.
16282368|NCT00773942|Behavioral|Enhanced medication therapy management|Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview and chart information.
16282369|NCT00773929|Drug|TAK-593|"Tablets of TAK-593 investigational drug for oral administration, tablets in 2 strengths: 1 mg and 4 mg tablets.
~Administration will initially be 4 mg, once a day and transition to 2 mg BID schedule dependant on safety"
16282370|NCT00773916|Drug|Methylphenidate|Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day
16282371|NCT00773890|Drug|TRF-1101|once daily treatment with 300 mg orally for 12 weeks
16282372|NCT00773890|Drug|Placebo|Daily treatment with TRF-1101 vehicle for 12 weeks
16282373|NCT00773851|Procedure|mesh fixation by transfacial sutures|mesh fixation by transfacial sutures
16282374|NCT00773851|Procedure|mesh fixation by staples|mesh fixation by staples
16282375|NCT00773838|Drug|Vorinostat|Four 100 mg vorinostat capsules orally, once daily (QD) by mouth on Days 1-14 of each 21-day treatment cycle.
16282376|NCT00773838|Drug|Bortezomib|Bortezomib 1.3 mg/m^2, IV injection QD on Days 1, 4, 8, and 11 of each 21-day treatment cycle.
16282377|NCT00773838|Drug|Dexamethasone|Five 4 mg Dexamethasone tablets orally, QD on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle if PD is observed after 2 treatment cycles or if NC to disease is observed after 4 treatment cycles.
16282378|NCT00773812|Drug|mecamylamine|The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.
16282379|NCT00773812|Drug|placebo|One pill is taken once daily.
16282380|NCT00773786|Drug|Arformoterol (Brovana)|twice daily via nebulizer added to maintenance daily tiotropium
16282381|NCT00773786|Drug|Placebo|Placebo twice daily for 1 week (added to maintenance tiotropium)
16282382|NCT00773773|Other|serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.|Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
16282383|NCT00773760|Other|SNP genotyping|Coded blood specimens will be transported to the Department of Gene Technology TTÜ and genotyping analysis will be performed. Lymphocytes will be isolated from blood specimens using Ficol-Paq gradients, and genomic DNA isolated using a salting-out procedure. Variants of the MOR gene and other genes of interests will be performed by DNA sequence analysis of PCR-amplified DNA, using primers located in flanking intron sequence. All methods proposed are currently in operation in the respective facilities.
16282384|NCT00773747|Drug|Vorinostat|Four 100 mg capsules vorinostat taken orally, once daily, on Days 1 through 14 of each 21-day treatment cycle.
16282385|NCT00773747|Drug|bortezomib|1.3 mg/m2 of bortezomib by IV push, on Days 1, 4, 8, and 11 of each 21-day treatment cycle.
16282386|NCT00773747|Drug|placebo to vorinostat|Four placebo capsules taken orally, once daily, on Days 1 through 14 of each 21-day treatment cycle.
16282387|NCT00773734|Drug|Apremilast 10mg|
16282388|NCT00773734|Drug|Apremilast 20mg|
16282389|NCT00773734|Drug|Apremilast 30 mg|
16282390|NCT00773734|Drug|Placebo|
16282391|NCT00773734|Drug|Apremilast 30mg|
16282392|NCT00773734|Drug|Apremilast 20mg|
16282393|NCT00773721|Device|CPAP mask|"Current CPAP masks are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable.
~Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame.
~Subjects will wear the test unit mask, instead of their current CPAP mask, each night whilst sleeping."
16282394|NCT00773708|Drug|raltegravir|intensify their therapy with Raltegravir(RAL):1 Protease inhibitor plus 2 nucleoside reverse transcriptase inhibitor plus RAL or 1 non-nucleoside reverse transcriptase inhibitor plus 2 nucleoside reverse transcriptase inhibitor plus RAL
16282395|NCT00773695|Drug|Aromatase Inhibitor|Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.
16282396|NCT00773695|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.
16282397|NCT00773695|Drug|Epirubicine|Participants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
16282398|NCT00773695|Drug|5-Fluorouracil (5FU)|Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
16282399|NCT00773695|Drug|Cyclophosphamide|Participants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
16282400|NCT00773695|Drug|Paclitaxel|Participants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.
16282401|NCT00773695|Drug|Docetaxel|Participants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
16282402|NCT00773682|Other|local mud-pack therapy and balneotherapy|Patients will be treated with local mud-pack application on the hands for 20 minutes and thermal-mineral bath once a day for 15 days.
16282403|NCT00773656|Other|Whole blood sample|70 ml per patient for collection of biological sample
16282404|NCT00773643|Other|biopsy|A biopsy of the patient's temporalis muscle, subcutaneous adipose, and bone tissue is the experimental procedure. The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. A very small fragment of each tissue type, 2mm X 2mm X 3mm biopsy, will be removed.
16282405|NCT00773630|Drug|Cilostazol|100 mg Cilostazol
16282406|NCT00773617|Behavioral|ICAT|ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
16282407|NCT00773617|Behavioral|CBT|CBT is a highly structured, manual-based psychotherapy that has been shown to be effective in the treatment of BN. CBT focuses on cognitions and bulimic behavior.
16282408|NCT00773604|Device|Medtronic implantable deep brain stimulation (DBS) system|surgical placement of deep brain stimulation system for treatment of dystonia
16282409|NCT00773591|Drug|NT 201, a Botulinum neurotoxin type A, free of complexing proteins|"NT 201: Solution for injection, one dose of 5 U will be administered. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.
~Placebo: Solution for injection, Dose n.a.; identical injected volume as active study medication. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge."
16282410|NCT00773578|Device|Measurement of exhaled nitric oxide (eNO)|Chemiluminescence NO analyzer Measurement of lung function (spirometry)
16282411|NCT00773578|Device|Measurement of biomarkers of nasal inflammation|Nasal lavage
16282412|NCT00773565|Dietary Supplement|Optifast|Formula diet for twelve weeks combined with physical activity and behavioral therapy
16282413|NCT00773552|Drug|solifenacin succinate|5mg PO Qday x 90 days
16282414|NCT00773552|Drug|placebo|1 tab PO Qday x 90 days
16282415|NCT00773539|Procedure|PVI using an open irrigated tip catheter|transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
16282416|NCT00773539|Procedure|PVI using a closed irrigated tip catheter|transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
16282417|NCT00773539|Procedure|PVI using a cryoballoon|transseptal PVI using the cryoballoon from CRYOCATH
16282418|NCT00773526|Drug|RO5126766|Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).
16282419|NCT00773513|Drug|Darbepoetin Alfa|Darbepoetin alfa will be administered as per approved label.
16282420|NCT00773513|Drug|Epoetin Alfa|Epoetin alfa will be administered as per approved label.
16282421|NCT00773513|Drug|Epoetin Beta|Epoetin beta will be administered as per approved label.
16282422|NCT00773513|Drug|methoxy polyethylene glycol-epoetin beta|Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)
16282423|NCT00773500|Other|Electronic prescribing|Implementation of a commercially available electronic prescribing system with clinical decision support
16282424|NCT00773487|Other|Bonchoscopy|Segmental instillation of allergen/Diesel particles; bronchoalveolar lavage
16282425|NCT00773474|Drug|Lonafarnib|All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
16282426|NCT00773461|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks for 24 weeks
16282427|NCT00773461|Drug|Placebo|iv every 4 weeks for 24 weeks
16282428|NCT00773448|Device|Comprehensive computed tomography of the abdomen/pelvis|Virtual colonoscopy and gastroscopy, a biphasic enhanced CT for hepatoma and renal cell carcinoma, parenchymal pancreatogram with minimum intensity projection (MinIP) reformation for pancreatic carcinoma, and finally uniphasic enhanced CT of distended bladder for bladder and ovarian carcinomas.
16282429|NCT00773448|Other|Limited Malignancy Screening|"1) A complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin, LDH); 4) renal function test (creatinine); 5) chest X-ray (if not performed in the past year)
~In women, a pap smear/pelvic examination (if > 18 and < 70 years old and not performed during the past year),a mammogram (> 50 years old) will be performed if not conducted in last year. Similarly for men, prostate examination +/- PSA testing (>40 years old) will be performed if not conducted in the past year."
16282430|NCT00773435|Biological|Echinacea purpurea 100 mg/ml in liquid formulation|10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
16282431|NCT00773435|Other|placebo|10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods
16282432|NCT00773422|Drug|naltrexone|25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
16282433|NCT00773422|Drug|varenicline|2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
16282437|NCT00773370|Behavioral|APA-Stroke|Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component.
16282438|NCT00773370|Behavioral|Sittercise|Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework.
16282439|NCT00773357|Drug|guanfacine|3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.
16282440|NCT00773357|Drug|placebo|placebo
16282441|NCT00773357|Drug|Carvedilol|50 mg/day titrated to stead state. The starting dose is 12.5 mg/day for day 1, followed by 25 mg/day for days 2-3, followed by 50 mg from days 4 to the end of the study.
16282442|NCT00773344|Drug|Tanespimycin|"Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT
~This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2)"
16282443|NCT00773331|Drug|epoetin beta|As prescribed
16282444|NCT00773331|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms every 4 weeks
16282445|NCT00773318|Procedure|SPECT/CT guided LM/SL|Detection, localization, and removal of sentinel lymph node (s) from prostate cancer guided by an integrated SPECT/low-dose multislice CT
16282446|NCT00773292|Drug|ciclosporin|Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration
16282447|NCT00773279|Device|FlexTouch®|All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.
16282448|NCT00773279|Device|FlexPen®|All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.
16282449|NCT00773253|Drug|Botulinum toxin A|All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
16282450|NCT00773240|Drug|Grazax|1 tablet, 75,000 SQ-T, daily during the trial period
16282451|NCT00773240|Drug|placebo|1 placebo tablet, matching the active treatment, daily during the trial period
16282452|NCT00773227|Procedure|Autologous myoblasts transplantation and myotomy|Graft of autologous cell muscles (myoblasts) isolated from unaffected limb muscles into the pharyngeal muscles of patients diagnosed as suffering from OPMD and surgical procedure (myotomy)
16282453|NCT00773214|Behavioral|Exercise|12-week supervised exercise programme (5 times /week at 75% maximal Heart Rate)
16282454|NCT00773201|Drug|Sotalol 80 mg|healthy subjects will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA
16282455|NCT00773188|Drug|bevacizumab [Avastin]|7.5mg/kg iv or 15mg/kg iv every 3 weeks
16282456|NCT00773188|Drug|cisplatin|75mg/m2 iv according to a standard chemotherapy treatment protocol
16282457|NCT00773188|Drug|vinorelbine|15mg/m2 iv according to a standard chemotherapy treatment protocol
16282458|NCT00773175|Drug|recombinant human hyaluronidase|150 Units in 1 mL
16282459|NCT00773162|Drug|Seroquel|seroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks
16282460|NCT00773162|Drug|Sugar Pill|Sugar pill to match seroquel
16282461|NCT00773149|Drug|Alemtuzumab (CAMPATH 1H) associated to G-CSF|"All patients receive Alemtuzumab in 3 successive phases:
~Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
~Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
~Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months."
16282462|NCT00773136|Drug|Bimatoprost Suspension|see prior
16282463|NCT00773110|Drug|20% Human albumin solution|Priming of the cardiopulmonary bypass circuit with Hartmann's solution (1000 mL), 20% Human serum albumin(300 mL), 0.9% sodium chloride solution (200 mL) and heparin (10,000 IU)
16282464|NCT00773110|Drug|Gelofusin|Priming of the cardiopulmonary bypass circuit with Hartmann's solution (1000 mL), Gelofusine (300 mL, 4% succinylated gelatin, a synthetic colloid) and heparin (10,000 IU)
16282465|NCT00773097|Biological|MUC1 - Poly ICLC|The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
16282466|NCT00773084|Drug|Aliskiren plus spironolactone vs. Lisinopril plus spironolactone|Subjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed.
16282467|NCT00773071|Device|SPECT/CT guided LM/SL|Pre-operatively, SLNs will be detected by low-dose SPECT/CT (99mTc-cystein rhenium colloids, 1cc/1mCi). Intra-operatively, a blue-dye (Patent Blue, 2cc) and a gamma-probe guidance will be used to detect the SLN nodes. All blue-stained and/or hot lymph nodes with a radioactivity greater than 10% of the hottest node will be considered as SLNs. Serial sections of SLNs will be analyzed by H-E staining. In cases of negative H-E, the SLNs will be further analyzed by immunochemistry (CKAE1/CKAE3, and high molecular weight Cytokeratin 34BE12). Non-SLNs will be analyzed as usual in routine by H-E.
16282468|NCT00773058|Drug|hydrocortisone|hydrocortisone 100mg q8h
16282469|NCT00773058|Drug|placebo|normal saline 100ml q8h
16282470|NCT00773045|Other|A Pain training program and pain measurement|Comparing patients treated with and without analgesia and sedation protocol
16282471|NCT00773019|Device|Refills (SynchroMed® II Programmable Drug Infusion Pump)|Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.
16282472|NCT00772980|Drug|Neramexane mesylate|Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
16282473|NCT00772980|Drug|Placebo|Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
16282474|NCT00772967|Drug|Naproxen|Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
16282475|NCT00772967|Drug|Placebo|Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
16282476|NCT00772967|Drug|Ultracet|Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
16282477|NCT00772954|Biological|Vaccine diluent buffer|0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
16282478|NCT00772954|Biological|Clostridium difficile toxoid vaccine (50 μg)|0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
16282479|NCT00772954|Biological|Clostridium difficile toxoid vaccine (100 μg)|0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
16282480|NCT00772941|Drug|Varenicline|"Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription.
~Frequency and duration are according to Package Insert as follows.
~The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."
16282481|NCT00772928|Biological|Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®|0.5 mL, Intramuscular
16282482|NCT00772928|Biological|Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®|0.5 mL, Intramuscular
16282483|NCT00772915|Drug|dexamethasone|"Dose: -40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
~If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle.
~If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly."
16282484|NCT00772915|Drug|lenalidomide|"25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
~Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described)."
16282485|NCT00772902|Drug|Truvada + Kaletra|Truvada (emtricitabine 200 mg/tenofovir DF 300 mg)once daily for oral administration according to prescription information. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
16282486|NCT00772902|Drug|Kivexa + Kaletra|Continuing Kivexa (abacavir sulfate 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
16282487|NCT00772889|Biological|Influenza vaccine GSK2186877A|One intramuscularly injection at Day 0
16282488|NCT00772889|Biological|GSK Biologicals' Fluarix™|One intramuscularly injection at Day 0
16282489|NCT00772876|Drug|P1446A-05|P1446A-05 capsules will be given once daily for 28 days in each 28 day cycle for 4 such cycles. The starting dose, for first cohort will be 75 mg once daily. Subsequent cohorts of patients will receive higher doses till the recommended phase II dose is identified.
16282490|NCT00772863|Drug|docetaxel and cisplatin|4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks
16282491|NCT00772837|Drug|Omeprazole + Clarithromycin + Amoxycillin|Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
16282492|NCT00772837|Drug|Omeprazole + placebo antibiotics|omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week
16282493|NCT00772824|Dietary Supplement|Glutamine|2g/kg body weight twice daily in divided doses for 5 days
16282494|NCT00772824|Dietary Supplement|IV Glutamine|50 ml of 20% glutamine IV before chemotherapy
16282495|NCT00772811|Drug|Flu-Mel|"Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
~Melphalan will be administered following the completion of Fludarabine infusion at day -2."
16282496|NCT00772798|Drug|Paclitaxel, Carboplatin and Vorinostat|Intravenous paclitaxel (175 mg/m2) and carboplatin (AUC 5) and oral vorinostat 400 mg day 1-14 every three weeks.
16282497|NCT00772785|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants 6-month duration)
16282498|NCT00772772|Drug|Vitamin D3|2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly)
16282499|NCT00772759|Drug|AZD3199 Turbuhaler®|240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)
16282500|NCT00772759|Drug|Placebo Turbuhaler®|single and multiple (o.d. for 12 days)
16282501|NCT00772720|Drug|raltegravir|raltegravir 400 mg BID for 7 days
16282502|NCT00772720|Drug|Placebo|Placebo BID for 7 days
16282503|NCT00772707|Device|Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)|OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.
16282504|NCT00772707|Device|Contact Lenses|Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.
16282505|NCT00772694|Drug|sorafenib|tablets 200mg, 400mg bid continuously in 4-week cycles
16282506|NCT00772681|Drug|docetaxel and cisplatin|3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks
16282507|NCT00772668|Drug|Rituximab|Administered intravenously during induction and maintenance therapy per protocol.
16282508|NCT00772668|Drug|Bortezomib|Administered intravenously per protocol.
16282509|NCT00772668|Drug|Cyclophosphamide|Administered intravenously per protocol.
16282510|NCT00772668|Drug|Prednisone|Administered orally (PO) per protocol.
16282511|NCT00772655|Drug|90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab|A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 [if platelets are below 150000/µl only 11 MBq/kg are administered).
16282512|NCT00772655|Drug|Rituximab|Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2-positivity 6 months after 90Y-Ibritumomab Tiuxetan.
16282513|NCT00772629|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16282514|NCT00772629|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16282515|NCT00772616|Drug|Remifentanil|closed-loop administration using bispectral index as the single input for the controller.
16282516|NCT00772616|Drug|Sufentanil|dosage according to usual criteria
16282517|NCT00772603|Drug|Placebo|Non-active tablet identical to study drug tablets
16282518|NCT00772603|Drug|2400mg SPN-804|tablets containing 600mg OXC XR, identical to non-active tablets
16282519|NCT00772603|Drug|1200mg SPN-804|two active tablets and two non-active tablets, all identical
16282520|NCT00772590|Drug|Raltegravir|Tablets, 400mg, twice daily
16282521|NCT00772590|Drug|Hyper-immune Bovine Colostrum|Tablet, 1800mg, twice daily
16282522|NCT00772590|Other|raltegravir placebo|One tablet, twice daily
16282523|NCT00772590|Other|Hyper-immune Bovine Colostrum placebo|Three tablets twice daily
16282524|NCT00772590|Drug|raltegravir and hyper-immune bovine colostrum|400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
16282525|NCT00772577|Drug|Aliskiren Hydrochlorothiazide|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
16282526|NCT00772577|Drug|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
16282527|NCT00772564|Drug|Atorvastatin|Oral Atorvastatin
16282528|NCT00772551|Drug|Raltegravir and ezetimibe|Group 1: raltegravir 400 mg orally twice daily for 10 days followed by 10 days of raltegravir 400 mg twice daily and ezetimibe 10 mg orally once daily for 10 days followed by a 10 days wash out period and ezetimibe 10 mg once daily for 10 days
16282529|NCT00772551|Drug|Ezetimibe and raltegravir|Group2: ezetimibe 10 mg orally once daily for 10 days followed by ezetimibe 10 mg and raltegravir 400 mg orally twice daily for 10 days followed by a 10 days wash out period and raltegravir 400 mg twice daily for 10 days
16282530|NCT00772538|Drug|tiotropium 5mcg/day|Intervention = randomisation: Patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo
16282531|NCT00772538|Drug|placebo|Matching placebo
16282532|NCT00772525|Drug|Nerispirdine|"form: tablet
~Route: oral"
16282533|NCT00772525|Drug|Placebo|"form: tablet
~Route: oral"
16282534|NCT00772512|Drug|PF-04802540|5 mg capsule, single dose
16282535|NCT00772512|Drug|PF-04802540|15 mg capsule, single dose
16282536|NCT00772512|Drug|Placebo|Placebo capsule, single dose
16282537|NCT00772499|Drug|olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure|Tablets and capsules for oral administration once or twice daily for up to 52 weeks
16282538|NCT00772499|Drug|atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure|Tablets and capsules for oral administration once or twice daily for up to 52 weeks
16282539|NCT00772486|Biological|ISF35|Subjects participating in this study will receive a course of three infusions of 3x10^8 ISF35-transduced cells at periods of not less than 14 days apart followed by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR) at monthly intervals.
16282540|NCT00772473|Other|subjects personal triptan|Subjects will treat 1 migraine attack with their usual triptan
16282541|NCT00772460|Device|Patient Warming with conductive / convective warming|Warming device set to maximum (43 °C)
16282542|NCT00772447|Drug|Daptomycin|4mg/kg IV ; Q 24 hr (once every 24 hours)
16282543|NCT00772447|Drug|Vancomycin|"Vancomycin - 1g per 12 hrs, for 7-14 days
~Or switch to
~Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin:
~- 1 g every 6 hours or 2 g every 8 hours"
16282544|NCT00772421|Device|There was no intervention.|There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.
16282545|NCT00772395|Drug|Risedronate|35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
16282546|NCT00772395|Drug|Placebo|Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)
16282547|NCT00772382|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
16282548|NCT00772356|Device|Accu-Chek Spirit Insulin Pump|
16282549|NCT00772356|Device|Comparator insulin pump|
16282550|NCT00772343|Biological|0.9% Normal Saline|0.5 mL, intramuscular on Days 0, 7, and 28
16282551|NCT00772343|Biological|Clostridium difficile toxoid vaccine|0.5 mL, intramuscular on Days 0, 7, and 28
16282552|NCT00772343|Biological|Clostridium difficile toxoid vaccine with adjuvant|0.5 mL, intramuscular on Days 0, 7, and 28
16282553|NCT00772343|Biological|Clostridium difficile toxoid vaccine|0.5 mL, intramuscular on Days 0, 7, and 28
16282554|NCT00772330|Device|Glaucoma Drainage Device|Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye
16282555|NCT00772317|Device|High Intensity Focused Ultrasound|High Intensity Focused Ultrasound
16282753|NCT00770913|Drug|E3810|20 mg taken orally, once a day for 8 weeks.
16282556|NCT00772304|Drug|Olopatadine 0.6% / Azelastine 137 mcg|single dose; 2 sprays per nostril
16282557|NCT00772291|Drug|pregabalin|pregabalin 150-600mg/day during 8 weeks
16282558|NCT00772291|Drug|placebo|placebo drug during 8 weeks
16282559|NCT00772278|Procedure|carotid artery stenting|carotid artery angiography, angioplasty and stenting
16282560|NCT00772278|Procedure|carotid endarterectomy|open surgery including endarterectomy
16282561|NCT00772265|Biological|Wosulin N|Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
16282562|NCT00772265|Biological|Novolin N|Total dose per subject will be 0.4 IU/Kg given Subcutaneously.
16282563|NCT00772252|Other|liver support treatment|plasma exchange for liver support treatment
16282564|NCT00772239|Device|Rotation thromboelastometry (ROTEM)|Coagulation measurement
16282565|NCT00772239|Procedure|Standard coagulation managment procedure|Standard coagulation managment procedure
16282566|NCT00772226|Device|music pillow|according to randomisation patients will receive with/without music.
16282567|NCT00772226|Device|pillow without music|According to randomisation patients will receive a pillow with/without music
16282568|NCT00772213|Procedure|MIGTS treatment|treatment of multiple trauma patients in the MIGTS
16282569|NCT00772200|Procedure|Cognitive Assessment|Complete COG Standard Neuropsychological and Behavioral Battery
16282570|NCT00772200|Other|Quality-of-Life Assessment|Ancillary studies
16282571|NCT00772187|Drug|morphine|Single dose: 0.1-0.5 mg
16282572|NCT00772187|Drug|intrathecal analgesia (morphine)|0.1-0.5 mg of morphine
16282573|NCT00772187|Drug|general anesthesia (fentanyl)|general anesthesia alone
16282574|NCT00772174|Drug|Pioglitazone and Metformin|Pioglitazone 15 mg, tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone 15 mg, tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.
16282575|NCT00772174|Drug|Metformin|Pioglitazone placebo-matching tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone placebo-matching tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.
16282576|NCT00772161|Drug|Methylphenidate|Comparison of two extended-release formulations of 20mg Methylphenidate in a cross-over design.
16282577|NCT00772148|Drug|LCP -Tacro|"LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
16282578|NCT00772148|Drug|Prograf|"Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
16282579|NCT00772135|Drug|sildenafil citrate|capsule of 50 mg , 90 minutes before exercise study
16282580|NCT00772122|Drug|G-CSF|daily sub-cutaneous administration of the recombinant G-CSF, at a dosage of 1 microgram (100000 IU)/kg/day from the 6th day after ovulation till the occurrence of menstruation or to the end of the 9th week of gestation.
16282581|NCT00772122|Drug|saline solution|daily sub-cutaneous administration of saline solution 0.2ml from the 6th day after the ovulation till to the recurrence of menstrual loss or to the end of the 9th week.
16282582|NCT00772109|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16282583|NCT00772109|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16282584|NCT00772109|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.1 mL, Intradermal
16282585|NCT00772109|Biological|Influenza Virus Vaccine USP Trivalent Types A and B|0.5 mL, Intramuscular
16282586|NCT00772096|Drug|n-3 fatty acids|
16282587|NCT00772083|Behavioral|Educational brochure|This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician.
16282588|NCT00772083|Behavioral|Standard pamphlet|The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.
16282589|NCT00772070|Biological|A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)|0.05 mL, Subcutaneous
16282590|NCT00772070|Biological|A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)|0.05 mL, Subcutaneous
16282591|NCT00772057|Drug|Propranolol|Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
16282592|NCT00772057|Drug|Placebo|Placebo tablets given two times daily.
16282593|NCT00772044|Device|Provent Professional Sleep Apnea Therapy Device|Application of active device (Provent)
16282594|NCT00772044|Device|Sham Device|Sham device will be applied
16282595|NCT00772031|Drug|propranolol LA|Propranolol LA up to 240 mg/day
16282596|NCT00772031|Drug|topiramate|Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.
16282597|NCT00772031|Drug|placebo|an inactive substance
16282598|NCT00772005|Drug|armodafinil|150 mg/day armodafinil
16282599|NCT00772005|Drug|placebo|placebo
16282600|NCT00772005|Drug|armodafinil|200 mg/day armodafinil
16282601|NCT00772005|Drug|armodafinil|250 mg/day armodafinil
16282602|NCT00771992|Procedure|Bronchoscopy|Bronchoscopy with segmental allergen challenge
16282603|NCT00771979|Drug|AZD0530|of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.
16282832|NCT00770471|Genetic|gene expression analysis|
16282604|NCT00771979|Drug|AZD0530|Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.
16282605|NCT00771966|Procedure|Standard therapy|Standard therapy
16282606|NCT00771966|Procedure|Maximization of cardiac stroke volume with fluid infusion|Maximization of cardiac stroke volume with fluid infusion
16282607|NCT00771953|Drug|apricoxib|Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day
16282608|NCT00771953|Drug|Placebo|Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day
16282609|NCT00771953|Drug|Docetaxel or Pemetrexed|Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 given as an IV infusion every 21 days. TheTreating physician will determine chemotherapy drug as per his usual practice.
16282610|NCT00771940|Drug|Ghrelin|Solvent, cont. infusion
16282611|NCT00771927|Drug|Lacosamide|Vimpat was used as per site routine practices, and in-line with the marketing authorization.
16282612|NCT00771914|Drug|Aspirin|Aspirin 81mg tablet
16282613|NCT00771914|Drug|Lovaza|Lovaza 4 grams
16282614|NCT00771914|Drug|Both Aspirin and Lovaza|Lovaza 4 grams plus aspirin 81 mg
16282615|NCT00771914|Other|Placebo|Capsule resembling fish oil and a tablet resembling aspirin
16282616|NCT00771901|Drug|tauroursodeoxycholic acid|1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.
16282617|NCT00771901|Other|placebo|7 pills daily for 4 weeks
16282618|NCT00771901|Drug|sodium phenylbutyrate|20g/day for four weeks.
16282619|NCT00771888|Drug|lanreotide|lanreotide
16282620|NCT00771875|Drug|Rabbit Antithymocyte Globulin (RATG)|All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
16282621|NCT00771875|Drug|Rituximab|Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
16282622|NCT00771875|Drug|Bortezomib|Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
16282623|NCT00771875|Drug|Acetaminophen|Patients will be premedicated with acetaminophen prior to dosing per institution standard of care.
16282624|NCT00771875|Drug|Antihistamine|Patients will be premedicated with an antihistamine prior to dosing per institution standard of care.
16282625|NCT00771875|Drug|Methylprednisolone|Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose.
16282626|NCT00771862|Procedure|perineural ropivicaine|Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.
16282627|NCT00771849|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16282628|NCT00771849|Biological|Haemophilus Influenzae Type b (Hib) vaccine|0.5 mL, Intramuscular
16282629|NCT00771823|Drug|Maraviroc|Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study
16282630|NCT00771823|Drug|Maraviroc|"Placebo twice daily for the first 14 days of the study.
~Maraviroc 300 mg twice daily for the last 14 days of the study."
16282631|NCT00771810|Drug|TXA127|Once daily subcutaneous injection of 100 ug/kg
16282632|NCT00771810|Drug|TXA127|Once daily subcutaneous injection of 300 ug/kg
16282633|NCT00771810|Drug|Placebo|Once daily subcutaneous injection of placebo
16282634|NCT00771797|Dietary Supplement|high dose flavanoids|flavanoid rich cocoa 2 times daily over 60 days
16282635|NCT00771797|Dietary Supplement|low dose flavanoids|treatment with flavanoid-low cocoa two times daily over 60 days
16282636|NCT00771771|Other|Early supported discharge with day unit rehabilitation|Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
16282637|NCT00771771|Other|Early supported discharge with home rehabilitation|Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
16282638|NCT00771758|Drug|oxycodone IR|maximum daily dose 450 mg
16282639|NCT00771758|Drug|placebo|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days
16282640|NCT00771758|Drug|tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days
16282641|NCT00771745|Drug|Thymoglobulin|Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
16282642|NCT00771745|Drug|Thymoglobulin|Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
16282643|NCT00771732|Device|light therapy|6 minute light therapy
16282644|NCT00771732|Device|light therapy|combination of wavelengths
16282645|NCT00771719|Drug|Ceftobiprole|Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
16282646|NCT00771706|Drug|Proton Pump Inhibitor|The PPI arm will consist of a two week course of PPI at a dose 1mg/kg/dose twice daily (minimum dose: 7.5 mg BID; maximum dose: 30 mg BID)
16282647|NCT00771706|Drug|Placebo|To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.
16282648|NCT00771693|Drug|Insulin aspart (Novorapid®)|a cross-over study with subcutaneous injection of insulin aspart 0.1U/kg, 0.2u/kg or placebo, before the meal, on 3 different occasions.
16282649|NCT00771680|Drug|insulin detemir|Start dose and frequency at the discretion of the physician following clinical practice
16282650|NCT00771680|Drug|biphasic insulin aspart 30|Start dose and frequency at the discretion of the physician following clinical practice
16282651|NCT00771680|Drug|insulin aspart|Start dose and frequency at the discretion of the physician following clinical practice
16282652|NCT00771667|Drug|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
16282653|NCT00771667|Drug|Ustekinumab 1mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group
16282654|NCT00771667|Drug|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
16282655|NCT00771667|Drug|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
16282656|NCT00771667|Drug|Placebo IV - Responder - Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
16282657|NCT00771667|Drug|Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
16282658|NCT00771667|Drug|Ustekinumab IV - Responder - Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
16282659|NCT00771667|Drug|Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
16282660|NCT00771667|Drug|Ustekinumab IV - Nonresponder - Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16
16282661|NCT00771667|Drug|Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
16282662|NCT00771654|Drug|Phentermine|Subjects will receive Phentermine 37.5mg everyday for one year
16282663|NCT00771654|Other|Placebo|daily for one year
16282664|NCT00771641|Procedure|conventional surgery|
16282665|NCT00771641|Radiation|low-LET cobalt-60 gamma ray therapy|
16282666|NCT00771641|Radiation|low-LET electron therapy|
16282667|NCT00771641|Radiation|low-LET photon therapy|
16282668|NCT00771641|Radiation|radiation therapy|
16282669|NCT00771628|Device|Flex-It Stylet|Patients will be intubated using the GlideScope with an ETT fitted with a Flex-It stylet.
16282670|NCT00771628|Device|Standard malleable stylet|Patients will be intubated using the GlideScope with an ETT fitted with a standard malleable stylet.
16282671|NCT00771615|Biological|GSK A/turkey H5N1 Influenza vaccine|One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
16282672|NCT00771602|Drug|Rituximab|375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.
16282673|NCT00771602|Drug|Alemtuzumab|Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).
16282674|NCT00771589|Device|Active Knee Prosthesis|Motorized External Knee Prosthesis for above knee amputees.
16282675|NCT00771563|Drug|cisplatin + docetaxel|docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
16282676|NCT00771563|Drug|cisplatin + docetaxel + enoxaparin|cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc
16282677|NCT00771537|Behavioral|Message Sidedness|There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
16282678|NCT00771524|Drug|Ceftobiprole|Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
16282679|NCT00771511|Drug|capsaicin|capsaicin cream 0.1% 10 ml applied to cervix
16282680|NCT00771511|Drug|Placebo|Only lidocaine gel will be appled to the cervix
16282681|NCT00771498|Drug|Lopinavir|ARV treatment: 2 NRTIs + lopinavir/r 800mg / 200 mg (4 tablets of Kaletra) every 12 hours, daily and orally Antituberculosis treatment: rifampin (600 mg/daily) + isoniazide (400 mg/daily) for 6 months, both in fasting condition + pirazinamide (2000 mg) for the first two months
16282682|NCT00771485|Drug|FM-602|Study of Efficacy of Bowel Preparation Before Colonoscopy
16282683|NCT00771485|Drug|Marketed Bowel Cleanser|Marketed bowel cleanser
16282684|NCT00771472|Drug|vorinostat|Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
16282685|NCT00771459|Drug|Ropivacaine 0.5 %|Local infiltration analgesia
16282686|NCT00771459|Drug|Isotonic NaCl|Local infiltration analgesia
16282687|NCT00771446|Biological|ELAD plus standard of care treatment|ELAD is a liver assist system - Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
16282688|NCT00771446|Other|Standard of care treatment|Standard of care for acute liver failure patients including medications and treatments typically given to these patients (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)
16282689|NCT00771433|Biological|filgrastim|Given subcutaneously
16282690|NCT00771420|Drug|CAM-3001|A single patient shall be dosed with a dose of 0.01mg/kg of CAM-3001 followed no sooner than 24 hours later by a second patient at a dose of 0.03mg/kg.
16282691|NCT00771420|Drug|CAM-3001|Dosed at 0.1mg/kg.
16282692|NCT00771420|Drug|CAM-3001|Dosed at 0.3mg/kg
16282693|NCT00771420|Drug|CAM-3001|Dosed at 1.0 mg/kg.
16282694|NCT00771420|Drug|CAM-3001|Dosed at 3.0 mg/kg.
16282695|NCT00771420|Drug|CAM-3001|Dosed at 10 mg/kg.
16282696|NCT00771420|Other|Placebo|Active: Placebo 5:1 for arms 2-6
16282697|NCT00771407|Device|Strattice Reconstructive Matrix|Strattice will be placed as a fascial inlay to support stoma sites
16282698|NCT00771407|Other|Standard ostomy creation|Ostomy will be created as routinely performed
16282699|NCT00771394|Drug|Tamsulosin hydrochloride|oral
16282700|NCT00771394|Drug|Solifenacin succinate|oral
16282701|NCT00771381|Drug|18F-FAZA PET scan|Radioactive dose of 18F-FAZA: 110-600 MBq per injection. One pre-treatment injection of 18F-FAZA and PET scan will be permitted per patient.
16282702|NCT00771381|Drug|FluGlucoScan Injection (18F-FDB) PET scan|Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.
16282703|NCT00771368|Drug|Nitric Oxide|1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days
16282704|NCT00771342|Drug|Nitric Oxide|1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days
16282705|NCT00771342|Drug|Nitrogen|Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days
16282706|NCT00771329|Drug|BIIB023|Single IV doses of BIIB023 in dose-escalating cohorts
16282707|NCT00771329|Other|Placebo (sterile normal saline)|Single IV dose of Placebo
16282708|NCT00771316|Drug|MK0826 (ertapenem)|A single dose of 1.0g IV infused over a 30 minute interval at hour 0
16282709|NCT00771316|Drug|Comparator: meropenem|500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days
16282710|NCT00771303|Other|Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.|
16282711|NCT00771290|Procedure|Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit)|comparison of Air insufflation to CO2 insufflation during intraoperative endoscopy
16282712|NCT00771277|Behavioral|Support Teams|Use of volunteers organized into teams with a coordinator to provide services to TBI family
16282713|NCT00771264|Device|Urgent PC Neuromodulation System|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
16282714|NCT00771251|Drug|CNTO 148|50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
16282715|NCT00771251|Drug|Placebo|Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116.
16282716|NCT00771238|Device|P500 Mattress|Study mattress
16282717|NCT00771225|Procedure|fascial repair|surgery to treat genital prolapse with fascia repair
16282718|NCT00771225|Procedure|mesh repair|surgery to genital prolapse with mesh
16282719|NCT00771212|Other|Observational pain control study|Observational pain control study
16282720|NCT00771199|Drug|Transdermal Therapeutic System (TTS)-Fentanyl|Participants will receive 1 transdermal patch of TTS-fentanyl containing 12 micrograms per hour (mcg/h) for 28 days. Dose can be increased or decreased as per Investigator's discretion up to 100 mcg/h.
16282721|NCT00771173|Drug|phenazopyridine HCl|Phenazopyrdine HCl 200 mg q8h x 24
16282722|NCT00771173|Other|Placebo|Placebo tablet administered q8 hours for 24 hours postop.
16282723|NCT00771160|Drug|montelukast sodium|Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.
16282724|NCT00771147|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.
16282725|NCT00771134|Drug|Lu AA39959|30mg/day; 15mg B.I.D. for 8 weeks
16282726|NCT00771134|Drug|Placebo|B.I.D. for 8 weeks
16282727|NCT00771134|Drug|Quetiapine|300mg/day for 8 weeks
16282728|NCT00771121|Drug|urea/lactic acid|new emulsion type
16282729|NCT00771121|Drug|Placebo|only emulsion base
16282730|NCT00771108|Behavioral|exercise|For 16 weeks subjects will exercise from 30-60 minutes five times a week.
16282731|NCT00771095|Behavioral|podcasting|
16282732|NCT00771056|Drug|Hydroxychloroquine|400mg by mouth daily x 1 year
16282733|NCT00771043|Drug|TYSABRI and AVONEX|TYSABRI and AVONEX treatment per package insert.
16282734|NCT00771030|Drug|AMG 827|Five treatment dose levels in Part A with AMG 827 and one dose level in Part B with AMG 827
16282735|NCT00771030|Other|Placebo|Five treatment dose levels in Part A with placebo and one dose level in Part B with placebo
16282736|NCT00771017|Biological|GVAX prostate cancer vaccine|Given intradermally
16282737|NCT00771017|Drug|bicalutamide|Given orally
16282738|NCT00771017|Drug|goserelin|Given intramuscularly
16282739|NCT00771017|Drug|leuprolide acetate|Given intramuscularly
16282740|NCT00771004|Drug|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for one week; increased to Pioglitazone 45 mg, tablets, orally, once daily for up to two weeks.
16282741|NCT00771004|Drug|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to three weeks.
16282742|NCT00770991|Drug|Black raspberry (BRB) Slurry|20 grams BRB Slurry
16282743|NCT00770991|Drug|Black Raspberry (BRB) Suppositories|Two, 730 mg BRB suppositories QHS
16282744|NCT00770991|Drug|Black Raspberry (BRB) Placebo Slurry|20 grams BRB placebo slurry
16282745|NCT00770978|Drug|ceftobiprole q12h|Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
16282746|NCT00770978|Drug|ceftobiprole q8h|Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
16282747|NCT00770965|Biological|AIN457|
16282748|NCT00770965|Biological|Placebo|
16282749|NCT00770952|Drug|Pioglitazone and Glimepiride|"Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 2 mg, tablets, orally once daily for two weeks; increased to:
~Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 4 mg, tablets, orally, once daily for two weeks; increased to:
~Pioglitazone 45 mg, tablets, orally, once daily and Glimepiride 4 mg, orally, once daily for up to 20 weeks."
16282750|NCT00770952|Drug|Glimepiride|"Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 4 mg, tablets, orally once daily for two weeks; increased to:
~Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 5 mg, tablets, orally once daily for two weeks; increased to:
~Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 6 mg, tablets, orally once daily for up to 20 weeks."
16282751|NCT00770939|Device|Vivostat PRF|Ulcer will be treated week 1,2,3,4,5 and 6 with Vivostat PRF
16282752|NCT00770926|Behavioral|Live Well, Be Well|Lifestyle change program using personal contact and telephone counseling
16282754|NCT00770913|Drug|E3810|10 mg, taken orally, twice a day for 8 weeks.
16282755|NCT00770913|Drug|E3810|20 mg taken orally, twice a day for 8 weeks.
16282756|NCT00770900|Drug|montelukast sodium|"Asthmatic children and teenagers took montelukast daily for 12 weeks.
~Children aged 2-5 years took 4mg tablet of montelukast
~Children aged 6-15 years took 5mg tablet of montelukast
~Children >15 years took 10mg tablet of montelukast"
16282757|NCT00770900|Drug|Comparator: placebo comparator|Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.
16282758|NCT00770887|Procedure|Self administration|Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).
16282759|NCT00770874|Drug|S-1 + Cisplatin (arm A)|S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
16282760|NCT00770874|Drug|Cisplatin (arm B)|Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
16282761|NCT00770861|Drug|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
16282762|NCT00770861|Drug|Placebo|Matching placebo tablets, oral administration
16282763|NCT00770848|Drug|AMG 102|Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
16282764|NCT00770848|Drug|AMG 102|Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.
16282765|NCT00770848|Drug|Mitoxantrone|Administered Q3W for a maximum of 12 cyles
16282766|NCT00770848|Drug|Placebo|Placebo
16282767|NCT00770848|Drug|Prednisone|5 mg orally BID
16282768|NCT00770835|Drug|Pioglitazone and Metformin|Pioglitazone 30 mg, tablets, orally, once daily, metformin stable dose and lifestyle modification for up to 24 weeks.
16282769|NCT00770835|Drug|Glibenclamide and Metformin|Glibenclamide 10 mg, tablets, orally, once daily and metformin stable dose and lifestyle modification for up to 24 weeks.
16282770|NCT00770822|Device|HIFU (Sonablate® 500)|High Intensity Focused Ultrasound
16282771|NCT00770822|Device|Brachytherapy|Standard of care
16282776|NCT00770796|Drug|Atorvastatin|80 mg die
16282777|NCT00770796|Drug|Placebo|
16282778|NCT00770783|Device|Thymatron|Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
16282779|NCT00770783|Device|Tonica MagPro MST|100% power, vertex placement, 3 times per week for 4 weeks
16282780|NCT00770770|Drug|Fluocinolone Acetonide|0.2 µg/day
16282781|NCT00770770|Drug|Fluocinolone Acetonide|0.5 µg/day
16282782|NCT00770757|Drug|CC-4047|
16282783|NCT00770744|Drug|Zicronapine|5-7mg/day; orally, encapsulated tablets, once daily
16282784|NCT00770744|Drug|Olanzapine|10-15mg/day; orally, encapsulated tablets, once daily
16282785|NCT00770731|Drug|Torisel (Temsirolimus)|Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle
16282786|NCT00770731|Drug|Hycamtin (Topotecan)|Starting Dose 0.8 mg/m^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle
16282787|NCT00770731|Drug|Velcade (Bortezomib)|Starting Dose 0.3 mg/m^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle
16282788|NCT00770718|Drug|Recombinant Activated Factor VII (rFVIIa)|Five patients who meet the selection criteria will be administered an intravenous dose of rFVIIa 1mg upon arrival. INR will be drawn at 20 minutes post-rFVIIa administration. If normalized (≤1.3), then repeat INR with be drawn every 2 hours thereafter for 6 hours total, and again at 24 hours after initial administration. If at any time, the INR is >1.3, then rFVIIa 1mg will be readministered and the INR will again be checked 20 minutes after administration and every 2 hours for 6 hours total and again at 24 hours post-administration. This may be repeated until a total dose of 80mcg/kg has been given.
16282789|NCT00770718|Drug|Prothrombin Complex Concentrate|5 patients will receive PCC based on ideal body weight. Each patient will receive 30 i.u./kg ideal body weight as is rounded to the nearest dispensed vial size. Vials are dispensed as 5mL (500 i.u.), 10mL (1000 i.u.), or 10mL (1500i.u.). INR will be drawn at 20 minutes post-administration and, if normalized (≤1.3), 2 hours post-administration and every 2 hours for 6 hours total. The INR will also be checked 24 hours post-administration. If at any time, the INR is >1.3, then PCC will be readministered at the same dose and the INR will again be checked 20 minutes after administration and every 2 hours for 6 hours total and again at 24 hours post-administration. A maximum total of 60 iu/kg can be administered.
16282790|NCT00770718|Biological|Fresh Frozen Plasma|Five patients will receive transfusions of FFP to normalize INR. If the initial INR is between 2-4, then 2 units of FFP (Round 1) will be administered emergently. If the initial INR is >4, then 4 units of FFP will be administered (Round 1). The INR will be checked after each round of FFP infusion completed. Once INR ≤1.3, then the INR will be again checked every 2 hours after normalization for 6 hours total and then 24 hours post-initial infusion. If the INR should ever return to >1.3, then repeat infusions of FFP will begin as outlined above and the INR will be checked serially as defined above.
16282791|NCT00770705|Drug|Phenoxybenzamine|The drug will be administered in the operating room. After induction of anesthesia and the pIacement of appropriate cardiovascular monitoring lines, an initial loading dose of 0.25 mg/kg will be administered intravenously immediately prior to cardiopulmonary bypass.For up to 72 hours postoperatively, 0.25 mg/kg/day will be administered Based on published pharmacokinetic data these doses should block 90 -95% of alpha-peripheral receptors with a half life of 24 - 36 hours for regeneration.
16282792|NCT00770705|Other|Standard surgical approach|Historical controls
16282793|NCT00770692|Drug|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
16282833|NCT00770471|Genetic|mutation analysis|
16282794|NCT00770692|Drug|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
16282795|NCT00770692|Drug|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
16282796|NCT00770692|Drug|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
16282797|NCT00770679|Drug|lipitor|80 mg everyday (QD) for 3 weeks
16282798|NCT00770666|Drug|Nicotine patch, nicotine inhaler, bupropion|Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily
16282799|NCT00770666|Drug|Nicotine patch|21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks
16282800|NCT00770653|Drug|Pioglitazone and Metformin|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
16282801|NCT00770653|Drug|Glimepiride and Metformin|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
16282802|NCT00770640|Drug|Pioglitazone and insulin|Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks.
16282803|NCT00770640|Drug|Insulin|Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks.
16282804|NCT00770627|Dietary Supplement|Omega 3 caps|Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day
16282805|NCT00770614|Drug|sodium bicarbonate solution|154 mEq/L in dextrose and H2O
16282806|NCT00770614|Drug|Isotonic saline|0.9% sodium chloride
16282807|NCT00770614|Drug|Placebo|Placebo
16282808|NCT00770601|Drug|Canakinumab|
16282809|NCT00770588|Drug|Gefitinib|Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD
16282810|NCT00770588|Drug|Placebo|To match Gefitinib
16282811|NCT00770575|Drug|Pioglitazone and atorvastatin|"Pioglitazone 30 mg, capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increase to:
~Pioglitazone 45 mg, capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks."
16282812|NCT00770575|Drug|Atorvastatin|"Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 20 mg, tablets, orally, once daily for 4 weeks; increased to
~Pioglitazone placebo-matching capsules, orally, once daily and atorvastatin 40 mg, tablets, orally, once daily for up to 20 weeks."
16282813|NCT00770562|Drug|rituximab|
16282814|NCT00770562|Drug|Dexamethasone|
16282815|NCT00770536|Drug|A1: AMG 386 10 mg/kg + Liposomal doxorubicin|Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW
16282816|NCT00770536|Drug|A3: AMG 386 15mg/kg + Liposomal doxorubicin|A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
16282817|NCT00770536|Drug|B1: AMG 386 10 mg/kg + Topotecan|B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule
16282818|NCT00770536|Drug|B3: AMG 386 15mg/kg + Topotecan|AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule
16282819|NCT00770510|Drug|Eszopiclone 1 mg|Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
16282820|NCT00770510|Drug|Eszopiclone 2 mg|Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
16282821|NCT00770510|Drug|Eszopiclone 3 mg|Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
16282822|NCT00770510|Drug|Placebo|Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
16282823|NCT00770510|Drug|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
16282824|NCT00770497|Drug|Pioglitazone|"Pioglitazone 15 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for two weeks; increased to:
~Pioglitazone 30 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for up to 10 weeks."
16282825|NCT00770497|Drug|Pioglitazone and ramipril|"Pioglitazone 15 mg, tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to:
~Pioglitazone 30 mg, tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks."
16282826|NCT00770497|Drug|Ramipril|"Pioglitazone placebo-matching tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to:
~Pioglitazone placebo-matching tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks."
16282827|NCT00770484|Drug|Propranolol then Placebo|Propanolol 20 mg, given orally within 1 hour prior to exercising
16282828|NCT00770484|Drug|Placebo then Propranolol|Placebo, matching pill given orally within 1 hour prior to exercising
16282829|NCT00770471|Drug|temozolomide|
16282830|NCT00770471|Drug|veliparib|
16282831|NCT00770471|Genetic|DNA methylation analysis|
16282834|NCT00770471|Genetic|proteomic profiling|
16282835|NCT00770471|Other|high performance liquid chromatography|
16282836|NCT00770471|Other|immunoenzyme technique|
16282837|NCT00770471|Other|laboratory biomarker analysis|
16282838|NCT00770471|Other|mass spectrometry|
16282839|NCT00770471|Other|pharmacogenomic studies|
16282840|NCT00770471|Other|pharmacological study|
16282841|NCT00770471|Procedure|adjuvant therapy|
16282842|NCT00770471|Radiation|radiation therapy|
16282843|NCT00770445|Drug|Pioglitazone and insulin|Pioglitazone 15 mg, tablets, orally, twice daily and metformin placebo-matching tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
16282844|NCT00770445|Drug|Pioglitazone and metformin and insulin|Pioglitazone 15 mg, tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
16282845|NCT00770445|Drug|Metformin and insulin|Pioglitazone placebo-matching tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
16282846|NCT00770432|Drug|Polyethylene glycol 3350|Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days.
16282847|NCT00770432|Other|Placebo, maltodextrin 500 powder for solution|Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.
16282848|NCT00770419|Other|medical chart review|
16282849|NCT00770419|Other|questionnaire administration|
16282850|NCT00770419|Procedure|psychosocial assessment and care|
16282851|NCT00770406|Drug|botulinum toxin type A|100 or 200 units intravesically
16282852|NCT00770393|Procedure|induction chemotherapy|Cisplatin was administered intravenously at a dose of 100 mg/m2 on day 1 and fluorouracil was administered at a dose of 1 000 mg/m2/day by continuous intravenous infusion on day 1 to 5 for 2 courses after 3 weeks. After induction chemotherapy patients underwent ears, nose and throat examination and computed tomography imaging. If a complete response (CR) or partial response (PR) of more than 80% is identified in the primary tumor, the patient was offered conventional radiotherapy as part of the protocol treatment. Radiotherapy was administered in 35 fractions of 2 Gy each over a 7 weeks period to the primary tumor (50 Gy) and the neck lymph nodes. The dose to the pathologically positive nodes was supplemented (20 Gy) at a total dose of 70 Gy. Doses and schedules of radiotherapy were identical in both treatment arms of the study.
16282853|NCT00770393|Procedure|Conventionnal chemotherapy|"Intravenous cisplatin at dose of 100 mg/m2 on days 1, 22 and 43 was administered concomitantly with conventional radiotherapy to the primary tumor and to the neck lymph nodes according to the pathological findings of the pre-treatment neck dissection at a total dose of 70 Gy.
~- Surgery was recommended to all patients who had a response less than 80%, stable disease or progressive disease in the primary tumor. If surgery was not feasible, the treatment choice was left up to the investigator's discretion."
16282854|NCT00770380|Behavioral|behavioral relapse prevention counseling|Behavioral relapse prevention counseling conducted in two one-hour sessions
16282855|NCT00770380|Other|hypnosis for relapse prevention|Hypnosis for relapse prevention conducted in two one-hour sessions
16282856|NCT00770367|Drug|Pioglitazone then Placebo|Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.
16282857|NCT00770367|Drug|Placebo then Pioglitazone|Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.
16282858|NCT00770354|Drug|AS1402|A complete treatment cycle spans 28 days. Patients randomised to AS1402 will receive a 1-hour infusion of 9 mg/kg on day 1, 8, 15 and 22 of each cycle. Patients will receive letrozole (2.5 mg daily tablet).
16282859|NCT00770354|Drug|Letrozole|Daily 2.5 mg oral letrozole tablet
16282860|NCT00770341|Drug|Daptomycin 4 mg/kg|MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
16282861|NCT00770341|Drug|Comparator: vancomycin|vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
16282862|NCT00770341|Drug|Daptomycin 6 mg/kg|MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
16282863|NCT00770328|Drug|Pentoxifylline|400mg PO TID x 8 weeks
16282864|NCT00770328|Drug|Placebo|PO TID x 8 weeks
16282865|NCT00770315|Biological|Ambrosia artemisiifolia allergen extract (Amb a 1-U)|Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.
16282866|NCT00770315|Biological|Placebo|Placebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily
16282867|NCT00770302|Drug|Saxagliptin|Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
16282868|NCT00770289|Other|Cohort|Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).
16282869|NCT00770263|Drug|Erlotinib|
16282870|NCT00770263|Drug|Temsirolimus|
16282871|NCT00770237|Behavioral|Smoking Cues|In the smoking cue condition, a pack of the participants preferred brand of cigarettes, a lighter, and an ashtray will be under the tray cover. In the neutral cue condition, a pack of unsharpened pencils, a pencil sharpener, and a small notepad will be under the cover. When instructed, the participant will lift the cover on the tray. In the smoking cue condition, participants will take one cigarette out of the pack, light it without puffing, hold it for 1 minute, extinguish the cigarette, and replace the cover on the tray.
16282872|NCT00770237|Behavioral|Neutral Cues|In the neutral cue condition, participants will take one pencil out of the pack, sharpen it, hold it for 1 minute as if to write on the notepad, and then replace the cover. Participants will complete the VAS during cue exposure and the TCQ-SF, VAS, and mood form immediately and 15 minutes after cue presentation; physiological measures will be recorded continuously.
16282873|NCT00770224|Biological|rituximab|
16282874|NCT00770224|Biological|tositumomab|
16282875|NCT00770224|Drug|cyclophosphamide|
16282876|NCT00770224|Drug|doxorubicin|
16282877|NCT00770224|Drug|prednisone|
16282878|NCT00770224|Drug|vincristine|
16282879|NCT00770224|Radiation|tositumomab|
16282880|NCT00770211|Drug|IncobotulinumtoxinA (Xeomin) (20 Units)|The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.
16282881|NCT00770211|Drug|Placebo|The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
16282882|NCT00770185|Drug|ridaforolimus|oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
16282883|NCT00770185|Genetic|gene expression analysis|
16282884|NCT00770185|Other|immunohistochemistry staining method|
16282885|NCT00770185|Other|laboratory biomarker analysis|
16282886|NCT00770172|Biological|filgrastim|Given subcutaneously
16282887|NCT00770159|Drug|odanacatib|Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.
16282888|NCT00770159|Drug|Comparator: placebo to MK0822|Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.
16282889|NCT00770146|Drug|Mipomersen sodium|200 mg/mL
16282890|NCT00770146|Drug|Placebo|1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).
16282891|NCT00770133|Drug|Ketotifen/naphazoline|One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
16282892|NCT00770133|Drug|Naphazoline|One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
16282893|NCT00770133|Drug|Ketotifen|One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
16282894|NCT00770133|Drug|Vehicle|One drop of vehicle ophthalmic solution at visit 3 and visit 4.
16282895|NCT00770120|Drug|everolimus|
16282896|NCT00770107|Drug|Thiamine|Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks
16282897|NCT00770107|Drug|Placebo|Placebo, once daily, for a duration of 4 weeks
16282898|NCT00770094|Device|Excimer Lasers|WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System
16282899|NCT00770094|Device|Excimer Laser for the LASIK procedure|WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System
16282900|NCT00770094|Device|Excimer Laser for LASIK|WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System
16282901|NCT00770081|Drug|vildagliptin|50mg qd
16282902|NCT00770081|Drug|sitagliptin|25mg qd
16282903|NCT00770055|Other|medical chart review|
16282904|NCT00770055|Other|questionnaire administration|
16282905|NCT00770055|Other|survey administration|
16282906|NCT00770055|Procedure|psychosocial assessment and care|
16282907|NCT00770042|Drug|Ritonavir|Ritonavir 300 mg bid for 1 day (Day 2), 400 mg bid for 1 day (Day 3), 600 mg bid for 5 days (Day 4-8)
16282908|NCT00770042|Drug|Ketoconazole|Ketoconazole 400 mg qd for 5 days (Days 2-6)
16282909|NCT00770042|Drug|Erythomycin|Erythromycin 500 mg every 12 hours for 5 days (Days 2-6)
16282910|NCT00770042|Drug|Avanafil|Avanafil 50 mg on Days 1 and 8
16282911|NCT00770042|Drug|Avanafil|Avanafil 50 mg on Days 1 and 6
16282912|NCT00770042|Drug|Avanafil|Avanafil 200mg Days 1 and 6
16282913|NCT00770029|Drug|IncobotulinumtoxinA (Xeomin) (20 Units)|The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.
16282914|NCT00770029|Drug|Placebo|The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
16282915|NCT00770016|Drug|Levothyroxin|Dosage regulation will follow the local recommendations of treatment
16282916|NCT00770003|Drug|AZD8848|nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month
16282917|NCT00770003|Drug|Placebo|nasal spray solution. Once weekly intranasal administrations for one month.
16282918|NCT00769990|Dietary Supplement|genistein|Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
16282919|NCT00769990|Radiation|radiation therapy|A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.
16282920|NCT00769964|Drug|VA111913 TS / placebo|
16282921|NCT00769951|Other|medical chart review|Data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years.
16282922|NCT00769951|Other|questionnaire administration|Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. The assessments include the Lawton's nine-item Instrumental Activities of Daily Living (IADL); the Katz's Activity of Daily Living (ADL); the Timed Up and Go Test; the Karnofsky Physician-Rated Performance Rating Scale (KPS); the number of falls in the past 6 months; the Mini Nutritional Assessment (MNA); the Body Mass Index; the percent of unintentional weight loss in the past 6 months; the Medical Outcomes Study (MOS) Social Support Subscale (emotional/information and tangible subscales); the MOS Social Activity Limitations Measures; the Charlson Comorbidity Index; the Cumulative Index Rating Scale Geriatrics (CIRS-G); the ACE-27; the Folstein's Mini-Mental State Examination (MMSE); the Geriatric Depression Scale (GDS); the Functional Pain Scale; and a list of medications.
16282923|NCT00769951|Procedure|cognitive assessment|Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
16282924|NCT00769951|Procedure|psychosocial assessment and care|Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
16283006|NCT00769392|Drug|Lidocaine 4%|A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
16282925|NCT00769951|Procedure|quality-of-life assessment|Patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care.
16282926|NCT00769938|Device|PCI (percutaneous coronary intervention)|only patients scheduled for PCI can be included tough this intervention would also take place without this study. What we want to study is the difference in outcome after a little change in the antithrombotic treatment
16282927|NCT00769925|Behavioral|Cognitive Behavior Therapy-Primary Care|Children will receive cognitive behavioral therapy from a child anxiety specialist at their doctor's office (the primary care clinic). The children will learn skills to cope with fear and anxiety, and parents will learn how to support their children in using these new skills.
16282928|NCT00769925|Behavioral|Therapist-Assisted Bibliotherapy-Primary Care|Parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries.
16282929|NCT00769912|Drug|50% N2O- 50%O2 mixture|50% N2O- 50%O2 mixture administration
16282930|NCT00769912|Drug|Placebo (air)|Placebo administration during the intervention
16282931|NCT00769899|Drug|AZD7325|Capsule for oral, single dose
16282932|NCT00769899|Drug|Placebo|Placebo capsule for oral, single dose
16282933|NCT00769886|Drug|Ketotifen/naphazoline|One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
16282934|NCT00769886|Drug|Ketotifen|One drop of Ketotifen in study eye at visit 3 and visit 4.
16282935|NCT00769886|Drug|Naphazoline|One drop of naphazoline in study eye at vist 3 and visit 4.
16282936|NCT00769886|Drug|Vehicle|One drop of vehicle in study eye at visit 3 and visit 4.
16282937|NCT00769873|Drug|Enoxaparin|Lovenox 40mg SC daily (30mg SC daily if creatinine clearance < 30) for 21 days
16282938|NCT00769860|Drug|Arimoclomol|Arimoclomol 100 mg TID for 4 months
16282939|NCT00769860|Other|Placebo|Placebo for 4 months
16282940|NCT00769847|Procedure|Endoscopic strip craniectomy|Surgery
16282941|NCT00769821|Other|questionnaire administration|
16282942|NCT00769821|Procedure|assessment of therapy complications|
16282943|NCT00769821|Procedure|bioimpedance spectroscopy|
16282944|NCT00769821|Procedure|quality-of-life assessment|
16282945|NCT00769808|Device|Bausch & Lomb 217z Excimer Laser|LASIK correction of myopia and myopic astigmatism
16282946|NCT00769795|Drug|IMC-A12|IMC-A12 will be administered every 2 weeks for a total of 6 doses at 10 mg/kg per dose. The last dose of IMC-A12 will be at least 2 weeks prior to prostatectomy.
16282947|NCT00769795|Drug|Bicalutamide|Bicalutamide 50 mg daily orally for 12 weeks
16282948|NCT00769795|Drug|Goserelin|10.8 mg subcutaneous once
16282949|NCT00769782|Procedure|therapeutic conventional surgery|All patients undergo suegery to achieve macroscopic complete resection within 28 days after enrollment (including enrollment day). As long as tumor free margin is ensured, all resection margin distances and all surgical procedure are accepted. Surgical treatment in this study excludes the following, radiofrequency ablation (RFA) without resection of liver only or microwave coagulation therapy (MCT) only; for RFA or MCT is used as additional treatment under judgment of primary physician for new liver tumor which comfirmed during surgery in different parts of liver except portion scheduled for resection, RFA and MCT are included. After histological curative resection, patients are observed without treatment until comfirming recurrence. Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally. For reccurrence is comfirmed, patients receive imatinib treatment, 400 mg/day orally.
16282950|NCT00769769|Behavioral|Psychotherapy|Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.
16282951|NCT00769769|Behavioral|Psychotherapy|Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.
16282952|NCT00769717|Behavioral|Wellness-Centered (HUGS)|A health at every size intervention, the HUGS program was conceived and developed in 1987 by Linda Omichinski, Registered Dietitian. HUGS stands for Health focused, Understanding lifestyle, Group supported, and Self-esteem building. It is an integrated approach that promotes healthy eating, active living, and self acceptance regardless of weight. HUGS teaches strategies to recognize and respond to physiological signs of hunger and satiety to determine food intake. The manualized curriculum is accompanied by the books Tailoring Your Tastes and Staying Off of the Diet Roller Coaster which participants will receive in addition to a booklet of handouts. Kelly Bliss, a psychotherapist and fitness professional with 17 years experience in health-centered approaches for weight management, will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
16282953|NCT00769717|Behavioral|Weight-Centered (LEARN)|The LEARN Program for Weight Management is an evidence-based behavior modification approach to weight loss developed by Dr. Kelly Brownell, Ph.D. Psychologist. LEARN is an acronym that stands for Lifestyle, Exercise, Attitudes, Relationships, and Nutrition. This manualized curriculum shares many principals with the HUGS program in that both emphasize the importance of healthy lifestyle choices and gradual sustainable change. However, the LEARN program makes weight loss an explicit goal and focuses more on food intake levels based on external prescriptions and caloric restriction. Participants in the LEARN program will receive the LEARN Program for Weight Management manual and the LEARN Weight Stabilization and Maintenance Guide along with the LEARN Program CD set. Ann Wellock, a Registered Dietician from The Reading Hospital and Medical Center will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
16282954|NCT00769704|Biological|Talimogene laherparepvec|Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
16282955|NCT00769704|Biological|GM-CSF|125 µg/m² subcutaneous injection
16282956|NCT00769678|Device|Stimulation of the diaphragm|Stimulation of the diaphragm using an electrode
16282957|NCT00769665|Other|Systane Ultra|Re-wetting ocular eye drop
16282958|NCT00769665|Other|Sensitive Eyes Rewetting Drops|Re-wetting ocular eye drop
16282959|NCT00769652|Behavioral|Medical nutrition therapy|Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule.
16283007|NCT00769392|Drug|Lidocaine 2% Injectable Solution|A subconjunctival injection of Lidocaine 2%
16282960|NCT00769652|Behavioral|Standard Care|"Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
16282961|NCT00769626|Other|Usual Care|Patients in the usual care group will receive advice and education to remain active and anticipate a favorable prognosis. Patients will also receive medication from the primary care provider consistent with current evidence-based guidelines(acetaminophen or non-steroidal anti-inflammatories). Consistent with current practice guidelines, patients will be instructed to return to the primary care provider if they are not satisfied with their progress after 4 weeks.
16282962|NCT00769626|Other|Early Treatment|Patients in the early treatment group will receive the usual care intervention (advice and education, and medication consistent with current evidence-based guidelines). Patients will also be referred to physical therapy for 4 sessions over a 3-week period. A standardized protocol will be used in physical therapy including spinal manipulation and trunk strengthening exercises. Patients will be instructed to return to the primary care provider if they are not satisfied with their progress after completion of the 4 sessions.
16282963|NCT00769613|Biological|cytomegalovirus IE-1-specific cytotoxic T lymphocytes|
16282964|NCT00769613|Biological|cytomegalovirus pp65-specific cytotoxic T lymphocytes|
16282965|NCT00769613|Biological|therapeutic allogeneic lymphocytes|
16282966|NCT00769613|Genetic|polymerase chain reaction|
16282967|NCT00769613|Other|flow cytometry|
16282968|NCT00769613|Other|immunological diagnostic method|
16282969|NCT00769613|Other|laboratory biomarker analysis|
16282970|NCT00769600|Drug|Itraconazole|Itraconazole 200 mg once daily
16282971|NCT00769600|Drug|Pemetrexed|Pemetrexed every 21 days.
16282972|NCT00769587|Drug|thalidomide|
16282973|NCT00769574|Other|Biological analysis of biomarkers|Biological analysis of biomarkers
16282974|NCT00769574|Other|Biological analysis of biomarkers|Biological analysis of biomarkers
16282975|NCT00769561|Behavioral|Biofeedback-Based Cognitive Behavioral Treatment|The biofeedback-based cognitive behavioral intervention comprises 8 individual sessions, each containing both cognitive behavioral and biofeedback elements. Treatment elements are education about the disorder, biofeedback training aimed at improving proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore patients receive portable biofeedback devices for EMG-biofeedback training during day and nighttime in order to reverse diurnal and nocturnal bruxing habits.
16282976|NCT00769561|Device|Dental treatment with occlusal splint (OS)|Maxillary or mandibular occlusal splints are made of hard acrylic after taking impressions of the upper and lower dental arches, face bow registration and recording of centric relation. Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night and during day time for a period of 7 weeks. One week after initial insertion of the splint patients are requested to return for adjustment.
16282977|NCT00769548|Drug|flutamide|Drug used for TAS.
16282978|NCT00769548|Drug|goserelin acetate|Drug used for TAS.
16282979|NCT00769548|Radiation|low-LET photon therapy|radiation therapy
16282980|NCT00769535|Genetic|Polymorphisms of HSP70 and TNF promoter|To assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR_RFLP
16282981|NCT00769522|Biological|Rituximab|"cycle 1: 375 mg/m² i.v., day 0, q28d
~cycle 2-6: 500 mg/m² i.v., day 1, q28d"
16282982|NCT00769522|Drug|Bendamustine|cycle 1-6: 90mg/m² i.v., day 1-2, q28d
16282983|NCT00769522|Drug|Cyclophosphamide|cycle 1-6: 250 mg/m² i.v., days 1-3, q28d
16282984|NCT00769522|Drug|Fludarabine|cycle 1-6: 25 mg/m² i.v., days 1-3, q28d
16282985|NCT00769509|Other|energy expenditure in preterm fed with preterm formula|Assessment of energy expenditure by indirect calorimetry in preterm infant fed with preterm formula 24 hours before measurements.
16282986|NCT00769509|Other|assessment of energy expenditure|assessment of energy expenditure in preterm infant during fed with human milk with fortifier
16282987|NCT00769496|Drug|BAY 77-1931|Lanthanum Carbonate (BAY 77-1931)
16282988|NCT00769483|Drug|MK-0646|Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
16282989|NCT00769483|Drug|Gemcitabine|1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
16282990|NCT00769483|Drug|Erlotinib|100 mg by mouth daily.
16282991|NCT00769470|Biological|trastuzumab|Given IV
16282992|NCT00769470|Drug|carboplatin|Given IV
16282993|NCT00769470|Drug|docetaxel|Given IV
16282994|NCT00769470|Drug|lapatinib ditosylate|Given orally
16282995|NCT00769457|Device|Access Arm|Active OptiVol-System with CareAlert via CareLink
16282996|NCT00769431|Other|educational intervention|
16282997|NCT00769431|Other|study of socioeconomic and demographic variables|
16282998|NCT00769418|Drug|odanacatib|"Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
~Panel A: odanacatib tablets 2.5 mg qd for 14 days.
~Panel B: odanacatib tablets 5 mg qd for 14 days.
~Panel C: odanacatib tablets 10 mg qd for 14 days.
~Panel D: odanacatib tablets 25 mg qd for 14 days.
~Panel E: odanacatib tablets 0.5 mg qd for 21 days.
~Panel F: odanacatib tablets 2.5 mg qd for 21 days.
~Panel G: odanacatib tablets 10 mg qd for 21 days."
16282999|NCT00769418|Drug|Comparator: Placebo|"Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
~Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.
~Panel B: placebo to odanacatib tablets 5 mg qd for 14 days.
~Panel C: placebo to odanacatib tablets 10 mg qd for 14 days.
~Panel D: placebo to odanacatib tablets 25 mg qd for 14 days.
~Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.
~Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.
~Panel G: placebo to odanacatib tablets 10 mg qd for 21 days."
16283000|NCT00769405|Drug|fluorouracil|Given IV
16283001|NCT00769405|Drug|leucovorin calcium|Given IV
16283002|NCT00769405|Drug|oxaliplatin|Given during surgery
16283003|NCT00769405|Procedure|hyperthermia treatment|Given intraperitoneally during surgery
16283004|NCT00769392|Drug|Proparacaine Ophthalmic|Drops of Proparacaine on the eye, administered as described in the package insert
16283005|NCT00769392|Drug|Tetracaine Ophthalmic|Drops of Tetracaine on the eye, administered as described in the package insert
16283008|NCT00769379|Other|Laboratory Biomarker Analysis|Correlative studies
16283009|NCT00769379|Biological|Trastuzumab|Given IV
16283010|NCT00769379|Radiation|Whole Breast Irradiation|Undergo standard whole breast irradiation
16283011|NCT00769366|Behavioral|Psychotherapy|humanistic-existential psychotherapy conducted in individual and group meetings
16283012|NCT00769366|Drug|Medical therapy|Optimal medical therapy after Acute myocardial infarction
16283013|NCT00769353|Behavioral|Primary and Secondary Coping Enhancement Training|A cognitive behavioral therapy designed to help individuals cope with physical illness.
16283014|NCT00769353|Behavioral|Supportive Non-directive Therapy|A non-structured therapy designed to provide a supportive atmosphere in which individuals may discuss concerns and process events in their lives
16283015|NCT00769327|Drug|imatinib mesylate|
16283016|NCT00769327|Drug|nilotinib|
16283017|NCT00769327|Genetic|cytogenetic analysis|
16283018|NCT00769327|Genetic|fluorescence in situ hybridization|
16283019|NCT00769327|Genetic|microarray analysis|
16283020|NCT00769327|Genetic|mutation analysis|
16283021|NCT00769327|Genetic|polymerase chain reaction|
16283022|NCT00769327|Genetic|polymorphism analysis|
16283023|NCT00769327|Other|laboratory biomarker analysis|
16283024|NCT00769314|Drug|Acyclovir Lauriad|50 mg muco-adhesive buccal tablets, single application on the gum
16283025|NCT00769314|Drug|Placebo|50 mg muco-adhesive buccal tablets, single application on the gum
16283026|NCT00769288|Drug|2'-F-ara-deoxyuridine|Given IV
16283027|NCT00769288|Other|positron emission tomography|Correlative studies
16283028|NCT00769288|Other|laboratory biomarker analysis|Correlative studies
16283029|NCT00769288|Other|pharmacological study|Correlative studies
16283030|NCT00769288|Other|pharmacogenomic studies|Correlative studies
16283031|NCT00769262|Other|Conservative weaning|Infants will not be weaned from the isolette until their feeds are at full calorie goal (120 kcal/kg/day) and at least half of feeds are taken orally.
16283032|NCT00769262|Other|Aggressive Weaning|Infants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU)
16283033|NCT00769249|Other|questionnaire administration|Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
16283034|NCT00769249|Other|study of socioeconomic and demographic variables|Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
16283035|NCT00769249|Procedure|psychosocial assessment and care|Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
16283036|NCT00769236|Other|Blood sampling and biopsy|Biopsy and blood : Research for various antibodies
16283037|NCT00769236|Other|Biopsy and blood sampling|Biopsy and blood : research for various antibodies
16283038|NCT00769236|Other|Biopsy and blood sampling|Blood and biopsy : research for various antibodies
16283039|NCT00769223|Other|medical chart review|
16283040|NCT00769223|Other|questionnaire administration|
16283041|NCT00769223|Procedure|quality-of-life assessment|
16283042|NCT00769223|Radiation|brachytherapy|
16283043|NCT00769223|Radiation|radiation therapy|
16283044|NCT00769210|Drug|Simvastatin|Simvastatin 40 mg tablet
16283045|NCT00769184|Drug|Corticosteroid|"One side of body:
~clobetasol: 2 applications / day along with LCD application 2 applications/day"
16283046|NCT00769184|Other|Placebo|"One side of body:
~Placebo Solution: 2 applications / day along with clobetasol 2 applications/day"
16283047|NCT00769184|Drug|LCD|"One side of body:
~LCD Solution: 2 applications / day along with clobetasol 2 applications/day"
16283048|NCT00769171|Drug|Avelox (Moxifloxacin, BAY12-8039)|Moxifloxacin 400 mg every 24 h
16283049|NCT00769171|Drug|Ceftriaxone + Metronidazole|Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
16283050|NCT00769158|Drug|Topiramate and Naltrexone|Topiramate 200 mg and Naltrexone 50 mg
16283051|NCT00769158|Other|Placebo|Placebo Comparator
16283052|NCT00769145|Drug|Ranibizumab|0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
16283053|NCT00769132|Drug|Comparator: niacin + laropiprant|ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days
16283054|NCT00769132|Drug|Comparator: niacin|ER niacin 2 g tablet once daily for 7 days
16283055|NCT00769132|Drug|Comparator: laropiprant|laropiprant 40 mg once daily for 7 days
16283056|NCT00769132|Drug|Comparator: placebo|matching placebo tablets for each of the interventions once daily for 7 days
16283057|NCT00769119|Drug|AZD9668|2 x 30 mg, oral tablet, twice daily for 28 days
16283058|NCT00769119|Drug|Placebo|2 x Matched placebo, oral tablet, twice daily for 28 days
16283059|NCT00769106|Biological|cytokine-induced killer cell (CIK) treatment|cytokine-induced killer cell treatment every two weeks, for 4 cycles
16283060|NCT00769093|Drug|Ferumoxytol|2 mg/kg
16283061|NCT00769067|Drug|Erlotinib|Continuous oral dosing at 150 mg daily.
16283062|NCT00769067|Drug|PF-00299804|Continuous oral dosing at 45mg daily
16283063|NCT00769054|Drug|Ropivacaine|Local Infiltration Analgesia with 1 % Ropivacaine
16283064|NCT00769054|Drug|Isotonic NaCl|Local Infiltration with NaCl
16283065|NCT00769041|Drug|moxifloxacin|400mg
16283066|NCT00769041|Drug|avanafil|100mg single dose
16283067|NCT00769041|Drug|avanafil|800mg single dose
16283068|NCT00769041|Drug|sugar pill|single dose
16283069|NCT00769028|Drug|Hyperimmune caprine serum|Subcutaneous injection of serum, 1ml twice weekly for 6 months
16283070|NCT00769028|Drug|Albumin|Subcutaneous injection of albumin, 1ml twice weekly for 6 months
16283071|NCT00769015|Behavioral|BA-LVR|Low vision clinic-based optometry plus 6 in-home occupational therapy visits
16283072|NCT00769015|Behavioral|ST-LVR|Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
16283073|NCT00769002|Biological|FluShield|Flu vaccine
16283074|NCT00769002|Biological|FluShield - same arm|Flu vaccine
16283075|NCT00769002|Biological|FluShield - opposite arm|Flu vaccine
16283076|NCT00769002|Procedure|Blood Draws|50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination
16283077|NCT00769002|Procedure|FDG PET-CT Scan|PET scan
16283078|NCT00769002|Genetic|Cytokine Profiling|Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination
16283079|NCT00768989|Drug|Atazanavir|Capsules, Oral, 300 mg, twice daily, 96 weeks
16283080|NCT00768989|Drug|Raltegravir|Tablet, Oral, 400 mg, twice daily, 96 weeks
16283081|NCT00768989|Drug|Atazanavir|Capsules, Oral, 300 mg, once daily, 96 weeks
16283082|NCT00768989|Drug|Ritonavir|Capsules, Oral, 100 mg, once daily, 96 weeks
16283083|NCT00768989|Drug|Tenofovir/Emtricitabine|Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks
16283084|NCT00768963|Drug|ranibizumab|0.5 mg subconjunctival ranibizumab 3 days prior to surgery
16283085|NCT00768963|Drug|ranibizumab|0.5 mg subconjunctival ranibizumab at the time of surgery
16283086|NCT00768950|Procedure|Capsule endoscopy examination|Examination of the small bowel with endoscopic videocapsule
16283087|NCT00768950|Procedure|Colonoscopy|Endoscopic examination of the large bowel and terminal ileum
16283088|NCT00768937|Drug|Sorafenib|All patients will receive Sorafenib (800 mg/day) p.o. beginning two weeks before the first TACE and every day thereafter until patient death or premature withdrawal from study.
16283089|NCT00768937|Procedure|Transarterial chemoembolisation (TACE)|TACE will be carried out with doxorubicin (75 - 50 - 25 mg/m2, depending on serum bilirubin levels ≤ 1.5, 1.5 - 3, 3 - 5 mg/dL) : lipiodol (1:1) in a total volume of 20 mL; after administration of doxorubicin:lipiodol, additional embolisation will be carried out with bead block-endospheres. TACE will be repeated every 4 weeks for 3 cycles; additional cycles will be offered if clinically indicated (but no PEI or RF-ablation should be carried out after inclusion into the study)
16283090|NCT00768911|Drug|CT-322|"Intravenous solution, intravenous administration, starting dose level of 0.5 mg/kg/week
~Dose levels: 0.5 mg/kg/week, 1.0 mg/kg/week, 2.0 mg/kg/week"
16283091|NCT00768911|Drug|Temozolomide|"75 mg/M2/day p.o. continuously 7 days per week during concurrent RT (max: 49 days)
~150 mg/M2/day X 5 days; adjuvant cycle #1
~200 mg/M2/day X 5 days; subsequent adjuvant cycles (# 2-12) if tolerability criteria met"
16283092|NCT00768911|Procedure|Radiation Therapy|RT will consist of fractionated focal irradiation administered using 2 Gy/fraction, QD x 5 days/week for 6 weeks, for a total dose of 60 Gy
16283093|NCT00768898|Other|2.5/5.0/10.0 ÂµL lissamine green|vital stain solution
16283094|NCT00768885|Device|PureVision 1|Currently marketed PureVision soft contact lens.
16283095|NCT00768885|Device|PureVision 2|Alternate design soft contact lens.
16283096|NCT00768859|Drug|paclitaxel, trastuzumab and carboplatin|paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3
16283097|NCT00768846|Device|Endeavor Resolute Stent|Zotarolimus-eluting Endeavor Resolute Stent
16283098|NCT00768846|Device|Xience V Stent|Everolimus-eluting Xience V Stent
16283099|NCT00768820|Drug|methylphenidate, fluoxetin, risperidone|first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate
16283100|NCT00768807|Device|CPAP (continuous positive airway pressure)|Patients treated by CPAP for 06 months
16283101|NCT00768794|Dietary Supplement|Acidophilus|"Use of Acidophilus in the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.
~The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region."
16283102|NCT00768794|Dietary Supplement|Acidolphilus|The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region.
16283103|NCT00768781|Behavioral|Mindfulness-Based Stress Reduction|The rationale for treatment is that MBSR targets arousal, which is a prominent perpetuating factor of insomnia. Each session meets weekly for 120 minutes and consists of a therapist-led mindfulness meditation, followed by a discussion of the meditation and its application into the participant's everyday life. For homework, each participant is required to practice formal meditation at least 45 minutes a day, 6 days per week. Participants will be provided a tape, an mp3 file, or CD to aid in the participant's personal practice at home. Formal meditations that will be led and discussed include eating meditation, body scan, sitting meditation, Hatha Yoga, and walking meditation. In addition, informal mindfulness practices will be discussed.
16283104|NCT00768781|Behavioral|Mindfulness-Based Therapy for Insomnia|MBTI treatment includes the hypothesized active elements of both mindfulness meditation and behavior therapy for insomnia. The intervention includes 8 weekly sessions. Each session meets weekly for approximately 120 minutes. The general format of each session includes formal mindfulness meditation (quiet and movement meditations) and instructions for the behavioral intervention, with a focus on integrating the principles of mindfulness with these instructions. Each participant is required to practice formal meditation for at least 45 minutes a day, 6 days per week as homework. Participants are provided a tape, mp3 file, or CD to aid in the participant's personal practice at home.
16283105|NCT00768781|Behavioral|Wait-List + Behavioral Therapy for Insomnia|This delayed treatment condition consists of an 8-week monitoring period (sleep diaries, PSAS) and then BT. The BT treatment consists of 8 sessions of behavioral interventions for insomnia, with instructions targeting the nighttime symptoms of insomnia. The primary components of this treatment package are stimulus control, sleep restriction, and sleep hygiene education. In the BT condition, each weekly session lasts 120 minutes and consists of formal instructions for the behavioral interventions along with a time for discussion of the application of these instructions into each participant's unique circumstances.
16283106|NCT00768768|Other|Electrokinetic Transungual System (ETS) - Terbinafine Gel|"Iontophoresis in conjunction with a terbinafine gel
~Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
~Two different drug applicators to be tested on each subject
~Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
~Iontophoretic Dose: 3 mA-min as 0.3 mA for 10 min"
16283107|NCT00768768|Other|ETS-Terbinafine Gel|"Iontophoresis in conjunction with a terbinafine gel
~Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
~Two different drug applicators to be tested on each subject
~Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
~Iontophoretic Dose: 6 mA-min as 0.5 mA for 12 min"
16283108|NCT00768768|Other|ETS-Terbinafine Gel|"Iontophoresis in conjunction with a terbinafine gel
~Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
~Two different drug applicators to be tested on each subject
~Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
~Iontophoretic Dose: 6 mA-min as 0.3 mA for 20 min"
16283109|NCT00768768|Other|ETS-Terbinafine Gel|"Iontophoresis in conjunction with a terbinafine gel
~Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
~Two different drug applicators to be tested on each subject
~Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
~Iontophoretic Dose: 10 mA-min as 0.5 mA for 20 min"
16283110|NCT00768768|Other|ETS-Terbinafine Gel|"Iontophoresis in conjunction with a terbinafine gel
~Drug Dose: ETS drug cartridge loaded with approximately 20 mg - 35 mg of terbinafine in the gel formulation, with the load depending on the size of the toenail to be treated.
~Two different drug applicators to be tested on each subject
~Single treatment on each toenail; one treatment with one drug applicator design, the second treatment with the alternative drug applicator design
~Iontophoretic Dose: 15 mA-min as 0.5 mA for 30 min"
16283111|NCT00768755|Drug|axitinib|5mg BID po up to max 10mg BID po
16283112|NCT00768755|Drug|axitinib|5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
16283113|NCT00768755|Drug|chemotherapy|Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
16283114|NCT00768755|Drug|axitinib|5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy
16283115|NCT00768755|Drug|chemotherapy|Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
16283116|NCT00768742|Device|VizAblate Intrauterine Ultrasound-Guided RF Ablation|VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.
16283117|NCT00768729|Drug|Sirolimus|Oral tablets or liquid taken every 12 hours. Dosage adjusted to attain target trough levels of 8-12 ng/mL. Participants who have maintained such levels at study entry on once daily dosage will be permitted to continue on once daily dosing.
16283118|NCT00768729|Drug|MMF or Azathioprine|600 mg/m2 MMF taken orally daily or Azathioprine orally daily. Dosage of Azathioprine is dependent on weight. MMF or Azathioprine will be reduced by 25% initially and by 25% every 2 months resulting in complete withdrawal by 6 months.
16283119|NCT00768716|Drug|Acetaminophen|2 x 500 mg by mouth once
16283120|NCT00768703|Device|Percutaneous endoscopic fetal tracheal occlusion/unocclusion|Between 26-28 wks' gestation, percutaneous endoscopic placement of the tracheal balloon. Between 32-34 wks' gestation, percutaneous endoscopic removal of the balloon.
16283121|NCT00768690|Drug|ABT-333|Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
16283122|NCT00768690|Drug|ketoconazole|Tablet, see arms for intervention description
16283123|NCT00768690|Drug|placebo|Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
16283124|NCT00768677|Drug|topiramate|
16283125|NCT00768664|Drug|PF-00299804|45 mg by continuous oral dosing
16283126|NCT00768651|Drug|Pantoprazole|Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
16283127|NCT00768651|Drug|Sitagliptin|Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.
16283128|NCT00768638|Drug|Atorvastatin|Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
16283129|NCT00768638|Drug|Atorvastatin|Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
16283130|NCT00768612|Drug|SCA-136 50mg/day|
16283131|NCT00768612|Drug|SCA-136 150 mg/day|
16283132|NCT00768612|Drug|SCA-136 300mg/day|
16283133|NCT00768612|Drug|Risperidone 4mg/day|
16283134|NCT00768599|Drug|Econazole Nitrate Cream 1%|Topical cream, applied once daily for 4 weeks.
16283135|NCT00768599|Drug|Econazole Nitrate Foam 1%|Topical foam, applied once daily for 4 weeks.
16283136|NCT00768599|Drug|Vehicle Foam|Topical foam, applied once daily for 4 weeks.
16283137|NCT00768573|Drug|sildenafil|Oral suspension of sildenafil.
16283138|NCT00768560|Drug|Nifedipine (Adalat CR, BAYA1040) 80mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
16283139|NCT00768560|Drug|Nifedipine (Adalat CR, BAYA1040) 40mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
16283140|NCT00768560|Drug|Nifedipine (Adalat CR, BAYA1040) 40mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
16283141|NCT00768521|Drug|tolterodine tartrate|"Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
~Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days
~Part IIb: single dose tolterodine tartrate 4 mg capsule"
16283142|NCT00768521|Drug|Comparator: Placebo to tolterodine tartrate|"Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
~Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days
~Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule"
16283143|NCT00768508|Drug|Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy|Ondansetron 4 ug/kg b.i.d.for 12 weeks
16283144|NCT00768508|Drug|Naltrexone 50 mg/day + Cognitive Behavioral Therapy|Naltrexone 50 mg/day for 12 weeks
16283145|NCT00768508|Drug|Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy|Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
16283146|NCT00768508|Other|Placebo + Cognitive Behavioral Therapy|Placebo comparator
16283147|NCT00768482|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants)
16283148|NCT00768482|Drug|Sublingual Buprenorphine|16 mg/day, QD
16283149|NCT00768469|Drug|Neratinib|Administered orally, continuous, once daily.
16283150|NCT00768469|Drug|Paclitaxel|Administered IV, on days 1, 8, 15 of 28 day cycle.
16283151|NCT00768456|Drug|Ropivacaine 0.5 %|Local Infiltration with Ropivacaine 0.5 %
16283152|NCT00768456|Drug|Isotonic NaCl|Local Infiltration with NaCl
16283153|NCT00768430|Drug|Ketamine|Single dose .5 mg/kg IV (in the vein) infused over 40 minutes
16283154|NCT00768430|Drug|Midazolam|single dose 0.045 mg/kg IV infused over 40 minutes
16283155|NCT00768417|Behavioral|10 chews|Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 10 times before swallowing.
16283156|NCT00768417|Behavioral|25 Chews|Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 25 times before swallowing.
16283157|NCT00768417|Behavioral|40 Chews|Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions. Almonds were to be chewed 40 times before swallowing.
16283158|NCT00768404|Drug|Topirmate and Phentermine|A single oral dose of the combination product VI-0521 (15 mg phentermine and 92 mg topiramate) will be administered with 240 mL of water at hour 0.
16283159|NCT00768391|Biological|IMC-3G3|Intravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week.
16283160|NCT00768378|Device|Training with the BrainPort balance device|Subjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other.
16283161|NCT00768352|Other|Educational intervention|An educational intervention which will consist of a standardized PowerPoint presentation that will cover general mental health topics such as depression and substance abuse. The presentation will also include discussion of common and validated mental health screening and assessment tools, as well as how to use these tools in a clinical setting. An educational packet will be provided to the residents and will include the screening tools, information on motivational interviewing and the behavioral stages of change, information on common medications prescribed for mental health disorders, and a bibliography of reputable resources for mental health topics.
16283162|NCT00768339|Drug|AEG35156 antisense IV infusion|"AEG35156 will be given as a 2-hour intravenous infusion (escalating dose 50, 100, 150, 200, 250 and 300 mg) once weekly on Day 1, Day 8 and Day 15. One cycle of therapy will consist of 21 days. Patients will be treated until disease progression.
~Patients must be pretreated for at least three days with allopurinol prior to the first dose of AEG35156 and throughout protocol therapy.
~Patients must be hydrated with 1 L of normal saline prior AEG35156 infusion"
16283163|NCT00768326|Drug|Zicronapine|"Study Part A:
~3mg; orally, film-coated tablets, once daily, 8 weeks"
16283164|NCT00768326|Drug|Zicronapine|"Study Part B:
~5mg; orally, film-coated tablets, once daily, 8 weeks"
16283165|NCT00768326|Drug|Zicronapine|"Study Part C:
~7mg; orally, film-coated tablets, once daily, 8 weeks"
16283166|NCT00768326|Drug|Zicronapine|"Study Part D:
~2 x 5mg; orally, film-coated tablets, once daily, 8 weeks"
16283167|NCT00768326|Drug|Zicronapine|"Study Part E:
~2 x 7mg; orally, film-coated tablets, once daily, 8 weeks"
16283168|NCT00768326|Drug|Placebo|"Study Part A, B, C, D and E:
~Placebo; orally, film-coated tablets, once daily, 8 weeks"
16283169|NCT00768313|Device|titanium rod|comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
16283170|NCT00768313|Device|ultra strength stainless steel rod|interventions involving rods of various strength to treat scoliosis
16283171|NCT00768300|Drug|Ambrisentan|Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
16283172|NCT00768300|Drug|Placebo|Placebo to match ambrisentan was administered orally once daily.
16283173|NCT00768287|Biological|IB1001|Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery
16283174|NCT00768287|Biological|nonacog alfa|Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa
16283175|NCT00768274|Drug|RVX000222|RVX000222 twice daily (b.i.d.) for 28 days
16283176|NCT00768274|Drug|Placebo|Placebo twice daily (b.i.d.) for 28 days
16283177|NCT00768261|Drug|Memantine (Namenda®)|Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.
16283178|NCT00768261|Drug|Donepezil (Aricept®)|5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
16283179|NCT00768248|Drug|perineural ropivacaine|ropivacaine 0.4%; the basal rate will be set at 7 mL/h
16283180|NCT00768248|Drug|normal saline (placebo)|the basal rate will be set at 7 mL/h
16283181|NCT00768235|Other|yoga practice|The yoga program comprised 70 min sessions, 3 times/week during 12 weeks
16283182|NCT00768222|Device|silk suture|skin closure
16283183|NCT00768222|Device|VICRYL* Plus suture|skin closure
16284226|NCT00760565|Drug|placebo|3mg/kg iv every 28 days for 3 infusions
16283184|NCT00768209|Drug|Phentermine and Topiramate|Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).
16283185|NCT00768183|Drug|KADIAN Capsule + alcohol (under fasting conditions)|Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
16283186|NCT00768183|Drug|KADIAN Capsule + water (under fasting conditions)|Capsules 100mg + 240 mL in 4 shots of 60 mL
16283187|NCT00768183|Drug|morphine sulfate IR oral solution + water|Morphine sulfate IR oral solution + water (under fasting conditions)
16283188|NCT00768183|Drug|KADIAN Capsule + alcohol (under fed conditions)|Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
16283189|NCT00768170|Drug|MK0633|MK0633 (50 mg) Oral, single dose
16283190|NCT00768157|Drug|antiviral treatment (lamivudine or entecavir)|antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)
16283191|NCT00768157|Procedure|radical resection of HBV-related HCC|Procedure/Surgery - radical resection of HBV-related HCC
16283192|NCT00768144|Drug|Sunitinib|
16283193|NCT00768131|Drug|Cetuximab|Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
16283194|NCT00768131|Drug|Paclitaxel|Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
16283195|NCT00768131|Drug|Carboplatin|Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
16283196|NCT00768118|Dietary Supplement|curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule|
16283197|NCT00768118|Genetic|electrophoretic mobility shift assay|
16283198|NCT00768118|Other|laboratory biomarker analysis|
16283199|NCT00768105|Drug|AZD1656|Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.
16283200|NCT00768105|Drug|Placebo|Dosing to match AZD1656
16283201|NCT00768079|Other|Placebo|A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
16283202|NCT00768079|Biological|Benralizumab|A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
16283203|NCT00768066|Biological|Autologous human mesenchymal cells (hMSCs)|Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hMSCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
16283204|NCT00768066|Biological|Autologous human bone marrow cells (hBMCs)|Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hBMCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
16283205|NCT00768066|Biological|Placebo|Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
16283206|NCT00768053|Drug|Etanercept|Etanercept 50 mg once a week
16283207|NCT00768040|Drug|Aliskiren|300 mg once daily
16283208|NCT00768040|Drug|Placebo|Matching placebo once daily
16283209|NCT00767988|Dietary Supplement|Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)|Capsules once daily at approximately the same time each day for 6 months.
16283210|NCT00767988|Other|Placebo|Capsule once daily at approximately the same time each day for 6 months.
16283211|NCT00767975|Drug|isoniazid , randomized, open label|isoniazid 300mg/tab 1 tab qd, 6 months (the other treatment arm is rifampin)
16283212|NCT00767975|Drug|rifampin, randomized, open label|rifampin 300mg/capsule 2 caps qd, 4 months (the other treatment arm is isoniazid)
16283213|NCT00767962|Other|talc pleurodesis under medical thoracoscopy|talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
16283214|NCT00767962|Other|pleurodesis under video-assisted thoracoscopy surgery|pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
16283215|NCT00767949|Biological|iSONEP|single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye
16283216|NCT00767897|Drug|Human Papillomavirus Vaccine|The HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks.
16283217|NCT00767871|Drug|Lexapro|12 week treatment with lexapro
16283218|NCT00767845|Other|questionnaire/survey administration|
16283219|NCT00767819|Drug|Everolimus|2.5 and 5 mg tablets taken orally and starting dose was 10 mg daily for all patients
16283220|NCT00767806|Drug|Duloxetine|60 mg orally once daily for 12 weeks
16283221|NCT00767806|Drug|Placebo|Placebo once daily orally for 12 weeks
16283222|NCT00767793|Drug|Placebo|One drop in each eye every 12 hours for seven days
16283223|NCT00767793|Drug|INS117548|One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
16283224|NCT00767793|Drug|INS117548|One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
16283225|NCT00767793|Drug|INS117548|One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
16283226|NCT00767780|Device|APOS biomechanical gait system|a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase
16283227|NCT00767767|Drug|Placebos|IV Saline infusion for 2 hours.
16283228|NCT00767767|Drug|Propofol 0.45mcg/mL|IV Propofol infusion for 2 hours.
16283229|NCT00767767|Drug|Propofol 0.90mcg/mL|IV Propofol infusion for 2 hours.
16283230|NCT00767767|Drug|Thiopental 1.5mcg/mL|IV Thiopental 1.5mcg/mL infusion for 2 hours
16283231|NCT00767767|Drug|Thiopental 3mcg/mL|IV Thiopental 3mcg/mL infusion for 2 hours
16283232|NCT00767754|Drug|Paxil CR|12 week treatment of Paxil(20-40mg)
16283233|NCT00767741|Device|with heat and massage|For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.
16283234|NCT00767728|Drug|Granulated mesalamine|0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning.
16283235|NCT00767728|Drug|Placebo|Matching placebo capsules (4 capsules) were administered orally QD, in the morning.
16283236|NCT00767715|Drug|olanzapine|physician determined dose, oral, daily, 5 months
16283237|NCT00767715|Drug|haloperidol|physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
16283238|NCT00767715|Drug|zuclopentixol|physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
16283239|NCT00767689|Drug|vitamin b6|vitamin b6 100 mg po daily
16283240|NCT00767689|Drug|placebo|placebo is given in the placebo arm
16283241|NCT00767676|Device|HP828-101|Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
16283242|NCT00767663|Drug|dipyridamole|dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
16283243|NCT00767663|Drug|placebo|placebo twice daily, minimal three days pretreatment
16283244|NCT00767637|Drug|Lanthanum Carbonate (BAY77-1931)|BAY77-1931 750mg, in the morning, day and evening
16283245|NCT00767624|Drug|Antidepressant|Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
16283246|NCT00767624|Behavioral|Desensitization Therapy for Insomnia|
16283247|NCT00767624|Behavioral|Cognitive Behavioral Therapy for Insomnia|
16283248|NCT00767598|Drug|phosphodiesterase type 5 inhibitor|single oral administration of 20mg vardenafil
16283249|NCT00767598|Drug|phosphodiesterase type 5 inhibitor|single oral administration of 100mg sildenafil
16283250|NCT00767598|Drug|phosphodiesterase type 5 inhibitor|single oral administration of 200mg udenafil
16283251|NCT00767572|Drug|atorvastatin|Atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout period, then cross over groups to complete another 12 weeks. (Total study time is 28 weeks (12+4+12)
16283252|NCT00767572|Drug|Sugar pill|atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout, then cross over groups X 12 weeks. Total study time is 28weeks (12+4+12).
16283253|NCT00767559|Drug|warfarin|5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 28 (+/-2 days) from day of surgery follow-up. (target INR 2.0 -2.5)
16283254|NCT00767559|Drug|Fondaparinux:|2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*, or 6-8 hours after epidural catheter removal, and continued until follow up day 28 (+/-2 days) from day of surgery.
16283255|NCT00767559|Drug|warfarin|"Fixed Low Dose warfarin
~1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until follow-up 28 day (+/- 2 days) from day of surgery."
16283256|NCT00767546|Drug|Botulinum toxin|60- 100 units Local injection to the rash area
16283257|NCT00767520|Drug|Exemestane + Dasatinib|Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
16283258|NCT00767520|Drug|Exemestane + Placebo|Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity
16283259|NCT00767507|Drug|cangrelor|
16283260|NCT00767507|Other|Placebo|Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
16283261|NCT00767494|Drug|Travoprost/Brinzolamide fixed combination|Eye Drops, suspension once daily
16283262|NCT00767494|Drug|Azopt|Eye Drop Suspension, 1 drop BID
16283263|NCT00767494|Drug|Travatan|Eye Drop Solution, 1 drop BID
16283264|NCT00767481|Drug|Travoprost/Brinzolamide|Eye drop suspension, once daily
16283265|NCT00767481|Drug|Cosopt|Eye drop solution, one drop BID
16283266|NCT00767468|Drug|sorafenib tosylate|Sorafenib 400mg BID until disease progression or patient withdrawal.
16283267|NCT00767455|Device|HP828-101|21 day patches
16283268|NCT00767429|Device|fall risk detector|fall risk detector: stumbles, specific fall related movements, falls
16283269|NCT00767416|Biological|MEDI-559|Cohort 1 (5 to <24 months): N=80 MEDI-559 at 10^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.
16283270|NCT00767416|Other|Placebo|Cohort 1 (5 to < 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.
16283271|NCT00767403|Behavioral|Internet Intervention + Stepped Care|"Participants will spend about 1 hour each week for 6 weeks using the Internet Intervention. In the first week, users will complete tutorials covering the three main components of treatment: 1) anatomy, physiology and pathophysiology of digestion; 2) education on clean-out and laxative treatments; and 3) behavioral treatment for encopresis. In subsequent weeks, users will complete weekly follow-ups, where they answer a series of questions about their progress and needs. The program then assigns additional intervention modules based on the difficulties the participants endorses. The 22 modules target a variety of issues including fears of toilet use; social isolation; administering, adjusting, and tapering laxatives; diet; hygiene; and preventing relapses. In addition to automatic emails, participants in this group will also receive additional support based on whether they complete specific intervention milestones."
16283272|NCT00767403|Behavioral|Internet Intervention|"As described in Arm 1 above, participants will spend about 1 hour each week for 6 weeks using the Internet intervention. In the first week, users will complete tutorials covering the three main components of treatment: 1) anatomy, physiology and pathophysiology of digestion; 2) education on clean-out and laxative treatments; and 3) behavioral treatment for encopresis. In subsequent weeks, users will complete weekly follow-ups, where they answer a series of questions about their progress and needs. The program will then assign additional intervention modules based on the difficulties the participant endorses. The 22 modules target a variety of issues including fears of toilet use; social isolation; administering, adjusting, and tapering laxatives; diet; hygiene; and preventing relapses."
16283273|NCT00767403|Behavioral|Patient Education Website|Participants will be given access to a relevant patient education website. It will contain material on managing and treating the behaviors and symptoms of childhood encopresis.
16283400|NCT00766376|Device|Erbium laser|Erbium laser treatment. Each subject will undergo up to 6 treatment sessions
16283274|NCT00767390|Device|ACL Patch|Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches.
16283275|NCT00767377|Drug|EOF5|epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks
16283276|NCT00767364|Biological|Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)|Oral vaccine for prevention of rotavirus infection, 3 dose series
16283277|NCT00767338|Behavioral|Timed intercourse|Timed intercourse
16283278|NCT00767338|Procedure|Microsurgical varicocelectomy|Microsurgical varicocelectomy
16283279|NCT00767338|Procedure|Intrauterine insemination|Intrauterine insemination
16283280|NCT00767325|Drug|Abatacept|Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169
16283281|NCT00767325|Drug|Methotrexate|Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline
16283282|NCT00767299|Drug|arzoxifene|20 mg, QD, PO,24 weeks
16283283|NCT00767299|Drug|Placebo|QD, PO, 24 weeks
16283284|NCT00767286|Drug|flutamide|
16283285|NCT00767286|Drug|goserelin acetate|
16283286|NCT00767286|Radiation|low-LET cobalt-60 gamma ray therapy|
16283287|NCT00767286|Radiation|low-LET photon therapy|
16283288|NCT00767273|Procedure|PET Scan|
16283289|NCT00767273|Drug|FLT|
16283290|NCT00767273|Drug|FDG|
16283291|NCT00767260|Drug|BM-MNC+HOT|Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy
16283292|NCT00767260|Drug|BM-MNC|Autologous Bone Marrow Mononuclear cell Infusion
16283293|NCT00767260|Device|HOT|Hyperbaric Oxygen Therapy
16283294|NCT00767260|Drug|SMT|hypoglycemic drugs or exogenous insulin
16283295|NCT00767234|Procedure|Observation|Standard of Care
16283296|NCT00767221|Drug|Budesonide|8 mg PL-56 once daily for six months
16283297|NCT00767208|Other|oral glucose load|oral ingestion of 13C labeled glucose
16283298|NCT00767182|Other|blood sample|biological markers evaluated : D-Dimer, sEPCR
16283299|NCT00767169|Device|Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate|Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth.
16283300|NCT00767156|Other|Omega7 Sea Buckthorn Oil Cream|The subjects use Omega7 Sea Buckthorn Oil Cream on the face, twice per day
16283301|NCT00767156|Other|Base cream|The subjects use the base cream on the face, twice per day
16283302|NCT00767156|Dietary Supplement|SBA24 Sea Buckthorn Oil Capsule|The subjects take SBA24 sea Buckthorn Oil Capsules, 2 x 2 capsules (2.0 g oil) per day and use topically Omega7 Sea Buckthorn Oil Cream, twice per day.
16283303|NCT00767156|Dietary Supplement|SBA24 Sea Buckthorn Oil Capsule|Teh subjects took SBA24 Sea Buckthorn Oil Capsule, 2 x 2 capsules (2 g oil) per day and use topically the base cream, twice per day
16283304|NCT00767117|Drug|Etravirine; Lopinavir; Ritonavir|
16283305|NCT00767104|Other|Silk like Pillowcase|sleep on silk-like pillowcase each night
16283306|NCT00767104|Other|Cotton Pillowcase|Sleep on placebo cotton pillowcase each night
16283307|NCT00767091|Drug|rivastigmine|transdermal patch of rivastigmine of 9.5 mg/day
16283308|NCT00767091|Drug|placebo|transdermal patch of placebo
16283309|NCT00767065|Radiation|Cardiac Computed Tomography|Patients randomised to the CCT arm will undergo 128-channel cardiac computed tomography with delayed acquisition. Patients will receive beta-blockade if necessary prior to the scan to achieve a heart rate of less than 70/min. An unenhanced scan will be performed in all patients to assess coronary artery calcium score. Patients will then undergo contrast enhanced CCT. After a bolus tracking acquisition, injection of 120mls iodinated contrast at 5ml/s will be followed by 40ml normal saline/contrast (in 50:50 proportion), also at 5ml/s. Imaging will be performed with a gated cardiac CT protocol. Where possible (stable rhythm and heart rate <70bpm) a low dose technique will be utilised. When not possible a retrospective gating method will be employed. In the latter case the ECG will be used to assign the images to their respective phases of the cardiac cycle. 10 minutes after contrast injection, a second prospectively gated scan will be acquired to assess myocardial enhancement patterns.
16283310|NCT00767065|Other|Standard care|Further investigations as decided by the patient's clinical team, according to best normal practice. These may include some or all of: further blood tests, exercise stress testing and myocardial perfusion scintigraphy. These may be conducted either during the initial hospital admission, or subsequently as an outpatient.
16283311|NCT00767052|Drug|AZD1236|75mg once daily or 75mg twice daily will be administered in multiple dose part.
16283312|NCT00767052|Drug|Placebo|Placebo tablet matching to the active in multiple dose part.
16283313|NCT00767052|Drug|AZD1236|75mg single dose will be administered in relative bioavailability part.
16283314|NCT00767052|Drug|AZD1236|75mg oral suspension single dose will be administered in relative bioavailability part.
16283315|NCT00767039|Drug|Survanta (beractant)|beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)
16283316|NCT00767039|Drug|Curosurf (poractant)|poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)
16283317|NCT00767026|Behavioral|COPE (Creating Opportunities for Parent Empowerment)|Twenty-four hours after admission to the hospital, this group will receive Phase I of the study which includes information focusing on what parents can expect during their child's hospital stay, and how they can help their child cope with the experience. Prior to discharge parents will receive additional information pertaining to Phase II of the study. At 3 days post discharge, the participants will receive a follow up phone call to reiterate the information provided in Phase II and ask parents about questions or problems since discharge. One week following, participants will be asked to complete assessments. At 6 weeks after the hospitalization they will receive Phase III, which includes, additional information on behaviors parents can expect to see in their children following a hospitalization. Parents will be given a workbook that will teach them techniques to help their child cope. Then at 6 weeks after the last intervention phase, participants will again complete assessments.
16283318|NCT00767026|Behavioral|Standard education|This group will receive standard education regarding medication management and seizure first aid. This group will also receive information, oral and written, that will discuss tests to be administered during the hospitalization. The usual care group also receives a call at home within one week after discharge from a nurse to ask if they had any problems with their stay, and if they have any further needs or questions.
16283319|NCT00767013|Other|DSCT, TTE|One assessment each
16283320|NCT00767000|Drug|MK-0941|MK-0941 tablets three times daily
16283321|NCT00767000|Drug|Comparator: Placebo|Matching placebo to MK-0941 three times daily
16283322|NCT00767000|Biological|Lantus|Lantus injection once daily
16283323|NCT00767000|Drug|Metformin|Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.
16283324|NCT00766974|Device|Anti-embolism Knee High Stocking|Anti-embolism Knee High Compression Stocking
16283325|NCT00766974|Device|20-30 Knee High Compression Stocking|20-30 mmHg Knee High COmpression Stocking
16283326|NCT00766961|Procedure|Trans-catheter arterial embolization|Trans-catheter arterial embolization
16283327|NCT00766961|Procedure|Surgery|Surgery
16283328|NCT00766948|Other|There is no intervention, this is a biorepository.|There are no interventions in this study.
16283329|NCT00766909|Drug|cyclosporine|"For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.155 mg/kg over a maximum duration of 5 hours.
~For Dialysis Patients (study 2): Oral intake of 4 mg/kg 2 times daily for 8-11 days."
16283330|NCT00766909|Drug|tacrolimus|"For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.0012 mg/kg over a maximum duration of 5 hours.
~For Dialysis Patients (study 2): Oral intake of 0.1 mg/kg 2 times daily for 8-11 days."
16283331|NCT00766909|Other|Capsules and isotonic saline|"For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.06 ml/kg isotonic saline over a maximum duration of 5 hours.
~For Dialysis patients (study 2): Placebo capsules 2 times daily for 8-11 days."
16283332|NCT00766896|Drug|Aspirin (platelet sensitive versus platelet hyperreactivity)|"The dose of aspirin to be prescribed in this study will be 300 mg orally or by nasogastric tube once a day (assisted therapy), with first dose tomography soon after admission if the patient has no indication of thrombolytic therapy. After the acute phase, patients will receive aspirin at a dose of 200 mg/day. Aspirin will be administered in a simple preparation (no buffer, no extended release)."
16283333|NCT00766883|Behavioral|Problem Solving Education|
16283334|NCT00766870|Drug|Lu AA34893|Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
16283335|NCT00766870|Drug|Venlafaxine extended release|Per oral, once daily, during 8 weeks, followed by a two-week tapering period
16283336|NCT00766870|Drug|Placebo|Per oral doses, twice daily as capsules during 10 weeks
16283337|NCT00766857|Drug|exenatide|Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
16283338|NCT00766857|Drug|Insulin glargine|Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.
16283339|NCT00766844|Device|spinal cord stimulation|electrode is inserted into cervical epidural space for continuous spinal cord stimulation
16283340|NCT00766831|Drug|Hydromorphone|Participants will receive hydromorphone OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
16283341|NCT00766818|Drug|Kaletra|Kaletra 400/100mg BID, then increase at 30weeks to 500/125mg BID
16283342|NCT00766805|Drug|EVL + Propranolol + Isosorbide 5 mononitrate|Treatment was started with propranolol at a dose of 40 mg twice a day. The heart rate and blood pressure were checked after 12 to 24 hours. The dose of propranolol was increased at increments of 20 to 40 mg per day until the patient achieved a heart rate of 55 bpm, or a maximum dose of 320 mg/day was achieved.ISMN was added at a dose of 10 mg twice a day. The dose was escalated at increments of 10-20 mg/day till a maximum dose of 40 mg/day was reached.
16283343|NCT00766805|Other|EVL alone|
16283344|NCT00766792|Procedure|Nocturnal dialysis|Switch to nocturnal dialysis (3 times 480 min/week)
16283345|NCT00766792|Procedure|Standard dialysis|Standard dialysis (3 times 240-270 min/week)
16283346|NCT00766779|Procedure|hematopoietic cell transplantation|low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
16283347|NCT00766779|Drug|Non-Transplant treatment approach for consolidation|Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.
16283348|NCT00766766|Behavioral|Health Risk and Behavioral Skills Coaching Sessions|Health Risk and Behavioral Skills Coaching Sessions
16283349|NCT00766766|Behavioral|Telephone Coaching Sessions|Telephone Coaching Sessions
16283350|NCT00766766|Behavioral|Physician Feedback Letter|Physician Feedback Letter
16283351|NCT00766753|Biological|Dendritic vaccine pulsed with multiple peptides|Subjects will receive four (4) injections of the vaccine into the lymph nodes. Injection is guided by ultrasonography. Subjects will receive the first cycle of vaccine in the right groin. Two weeks after the first vaccine, subjects receive the same vaccine at the left groin, followed by the 3rd and the 4th vaccines in the left and right armpits, respectively, with two-week intervals. Each injection contains 0.2cc (less than 1/20th of a teaspoon) of a saline solution containing the vaccine cell mixture.
16283352|NCT00766753|Biological|The first booster vaccine phase:|This phase will begin at week 13. These subjects will be treated with additional vaccinations every 4 weeks to a maximum of 5 vaccine injections and, if poly-ICLC is available from the supplier starting on the day of the first additional vaccine and twice/week for 8 injections following each additional vaccine. If poly-ICLC supply is not available from the supplier, DC vaccines only will be given in the booster phases.
16283401|NCT00766363|Drug|EVP-6124 (0.1 mg/day)|EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.
16283402|NCT00766363|Drug|EVP-6124 (0.3 mg/day)|EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.
16283353|NCT00766753|Biological|The second booster vaccine phase:|"At week 33, following the completion of 5 additional vaccines, if participants demonstrate stable disease or positive clinical response, if poly-ICLC supply is still available, participants will be offered additional DC-vaccines and poly-ICLC treatment. The second phase booster vaccines can be continued as long as the patient shows continued positive response or stable disease (both radiological and clinically) with no major adverse events, and as long as funding is available for the study. DC vaccines in this phase will be administered every 6 months+/- 2 weeks.
~2). Poly-ICLC at 10µg/kg and up to 1640 µg/injection will be administered intramuscularly (i.m.) on the day of each booster DC vaccine. Poly-ICLC will be administered weekly thereafter for twice (at one week and two weeks after each vaccine) (e.g. if the previous DC vaccine was administered on a Thursday, subsequent poly-ICLC will be administered on the next two Thursdays"
16283354|NCT00766740|Device|thrombectomy devices|mechanical or manual devices able to remove thrombus from the coronary arteries.
16283355|NCT00766740|Device|angioplasty|percutaneous coronary angioplasty with use of balloon catheters and bare metal stents or drug eluting stents.
16283356|NCT00766727|Device|GLYDe Dressing|Wound dressing intended to minimize scar formation
16283357|NCT00766714|Device|Cook K-SOFT-5100 catheter|A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI
16283358|NCT00766714|Device|Frydman classical catheter|A Frydman classical catheter was used for embryo transfer in human IVF/ICSI
16283359|NCT00766701|Procedure|Procedure: Spectroscopy and Digital Imaging|Procedure: Spectroscopy and Digital Imaging
16283360|NCT00766688|Drug|AVE5530|"one tablet in the evening with dinner
~in addition to high doses of statin treatment"
16283361|NCT00766688|Drug|Placebo|"one tablet in the evening with dinner
~in addition to high doses of statin treatment"
16283362|NCT00766675|Drug|Tramadol hydrochloride|Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
16283363|NCT00766675|Drug|Acetaminophen|Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
16283364|NCT00766662|Drug|Sulfadoxine pyrimethamine|
16283365|NCT00766649|Drug|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
16283366|NCT00766636|Drug|Gemcitabine|"Arm A:
~1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.
~Arm B:
~400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day."
16283367|NCT00766636|Radiation|Radiation Therapy|1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.
16283368|NCT00766636|Drug|Erlotinib|100 mg daily by mouth on days 1-42.
16283369|NCT00766636|Procedure|Surgery|Surgical removal of the pancreas and duodenum
16283370|NCT00766623|Dietary Supplement|high fat meal|milkshake containing 95g fat
16283371|NCT00766623|Dietary Supplement|control meal|milkshake comparable with a normal breakfast
16283372|NCT00766597|Drug|Vicriviroc|Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
16283373|NCT00766584|Other|Sleep apnea/hypopnea detection|Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.
16283374|NCT00766545|Drug|cilostazol|oral tablet 100 mg, twice daily, over 1 year
16283375|NCT00766545|Drug|placebo of cilostazol|oral tablet, 0 mg twice daily, over 1 year
16283376|NCT00766532|Drug|Aromatase Inhibitor|Any aromatase inhibitor started as initial adjuvant therapy
16283377|NCT00766519|Other|volume optimization|"Fluid management:
~basal fluid administration = 5 ml/kg/h lactated Ringer's solution
~+ systematic minimization of the arterial pulse pressure variation (PPV) to 10% or less by volume loading (6% hydroxyethyl starch) throughout surgery
~hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) only if PPV is > 10%"
16283378|NCT00766519|Other|standard volume administration|"Fluid management:
~basal fluid administration = 5 ml/kg/h lactated Ringer's solution
~hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) according to predetermined algorithm primarily based on mean arterial pressure, heart rate, and urine output, and secondary on PPV"
16283379|NCT00766506|Device|Fentanyl IONSYS|Participants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).
16283380|NCT00766506|Device|Morphine IV PCA|Morphine sulphate solution will be administered intravenously (IV) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
16283381|NCT00766493|Device|GORE® Embolic Filter|Embolic protection during carotid stenting
16283382|NCT00766480|Drug|cisplatin|Given IV
16283383|NCT00766480|Drug|fluorouracil|Given IV
16283384|NCT00766480|Radiation|radiation therapy|Patients undergo radiotherapy
16283385|NCT00766467|Drug|Armodafinil|Taken orally once a day in the morning. Dose will change depending upon level of fatigue
16283386|NCT00766467|Other|Placebo|Placebo taken once a day in the morning
16283387|NCT00766454|Genetic|DNA analysis|
16283388|NCT00766454|Genetic|mutation analysis|
16283389|NCT00766454|Genetic|polymorphism analysis|
16283390|NCT00766454|Other|laboratory biomarker analysis|
16283391|NCT00766454|Other|medical chart review|
16283392|NCT00766454|Other|questionnaire administration|
16283393|NCT00766454|Procedure|evaluation of cancer risk factors|
16283394|NCT00766441|Drug|Sitagliptin|tablet, 100mg, once daily, 4 weeks
16283395|NCT00766441|Drug|sulphonylurea|sulphonylurea, variable, od or bd, during ramadan
16283396|NCT00766415|Drug|AZD1981|Oral tablet, twice daily, 4 weeks treatment
16283397|NCT00766415|Drug|Placebo|Placebo
16283398|NCT00766402|Drug|Tramadol /acetaminophen|Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.
16283399|NCT00766402|Drug|Diclofenac|Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
16283403|NCT00766363|Drug|EVP-6124 (1.0 mg/day)|EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.
16283404|NCT00766363|Drug|Comparator: Placebo|Matching placebo was administered as one capsule per day for 28 days.
16283405|NCT00766363|Drug|Donepezil|Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.
16283406|NCT00766363|Drug|Rivastigmine|Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.
16283407|NCT00766350|Drug|amitriptyline|initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
16283408|NCT00766350|Drug|quetiapine|initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
16283409|NCT00766337|Drug|Sirolimus in combination with ranibizumab|Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
16283410|NCT00766337|Drug|Sirolimus in combination with ranibizumab|Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
16283411|NCT00766337|Drug|Placebo in combination with ranibizumab|Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
16283412|NCT00766324|Drug|PHA-739358|6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
16283413|NCT00766324|Drug|PHA-739358|24-hr IV infusion every 2 weeks in a 4-week cycle
16283414|NCT00766311|Other|Gross Motor Function|The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility. We will use the total motor composite to describe overall motor function.
16283415|NCT00766311|Other|Knee extension strength|"Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is broken."
16283416|NCT00766311|Other|Hand grip strength|Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.
16283417|NCT00766311|Other|Flexibility|Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.
16283418|NCT00766311|Other|Ankle range of motion|Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures
16283419|NCT00766311|Other|Aerobic capacity|Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02
16283420|NCT00766311|Other|Body composition and vital signs|Height, body mass index, waist circumference, and blood pressure will be measured.
16283421|NCT00766298|Behavioral|Exercise|16 week intervention; 6 exercise sessions weekly w 3 supervised exercise sessions weekly utilizing cycling or walking/jogging. Participants maintain exercise diaries: wks 1-4; 30 minutes at 60-70% MHR, wks 5-8; 40 minutes at 60-70% MHR, weeks 9-16; 40 minutes at 75% MHR
16283422|NCT00766298|Behavioral|Weight Loss|The reduction of kcal/day through implementation of low fat diet
16283423|NCT00766298|Behavioral|Exercise and weight loss|"Exercise: 16 week intervention; 6 exercise sessions weekly w 3 supervised exercise sessions weekly utilizing cycling or walking/jogging. Participants maintain exercise diaries: wks 1-4; 30 minutes at 60-70% MHR, wks 5-8; 40 minutes at 60-70% MHR, weeks 9-16; 40 minutes at 75% MHR.
~Weight Loss: Reduction of kcal/day through implementation of a low fat diet."
16283424|NCT00766285|Biological|Trivalent inactivated influenza vaccine|Standard trivalent influenza vaccine consisting of 15 mcg per antigen (45 mcg total) by intramuscular deltoid injection.
16283425|NCT00766285|Biological|Trivalent Baculovirus-expressed Influenza HA vaccine|Influenza virus hemagglutinin proteins expressed in insect (SF+) cells under serum free conditions by recombinant baculovirus.
16283426|NCT00766272|Device|Lokomat|Body-weight will be supported using a harness, which suspends the subject above a motorized treadmill (Lokomat, Hocoma, Zurich, Switzerland). The system also incorporates a robot-driven gait orthotic, called the Lokomat, which will be secured to the subject's lower extremity and pelvis using adjustable cuffs and pads. The Lokomat uses computer-controlled motors to drive the hips and knees toward more normative kinematic patterns for gait.
16283427|NCT00766246|Drug|bevacizumab|15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance
16283428|NCT00766246|Drug|docetaxel|75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
16283429|NCT00766246|Drug|carboplatin|AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment
16283430|NCT00766233|Other|Hyperthermal treatment|Hyperthermal treatment one or three times per week for 60 minutes
16283431|NCT00766220|Drug|SIR-spheres Agent Administration|SIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes.
16283432|NCT00766220|Drug|Cetuximab|"400 mg/m2 by vein over 2 hours once a week.
~Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions."
16284227|NCT00760565|Drug|placebo|7mg/kg iv every 28 days for 3 infusions
16283433|NCT00766220|Drug|Irinotecan|350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks.
16283434|NCT00766207|Other|Clinical decision support|multi-faceted decision support
16283435|NCT00766207|Other|stream-lined clinical alert|electronic notification that a medication is potentially teratogenic
16283436|NCT00766181|Behavioral|Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system|0.5 mg lidocaine hydrochloride
16283437|NCT00766168|Other|HDS HI 1.54; pahrifocon A|Contact Lens
16283438|NCT00766168|Device|FluoroPerm 30 RGP; paflufocon C|Contact lens daily wear
16283439|NCT00766155|Drug|capecitabine|Given orally
16283440|NCT00766155|Drug|oxaliplatin|Given IV
16283441|NCT00766142|Biological|cetuximab|
16283442|NCT00766142|Drug|fluorouracil|
16283443|NCT00766142|Drug|leucovorin calcium|
16283444|NCT00766142|Drug|oxaliplatin|
16283445|NCT00766142|Procedure|adjuvant therapy|
16283446|NCT00766142|Procedure|therapeutic conventional surgery|
16283447|NCT00766129|Device|Taxus stent implantation|Patients will be treated with implantation of Taxus stent
16283448|NCT00766129|Device|Luc-Chopin stent|Patients will be treated will implantation of Luc-Chopin stent
16283449|NCT00766116|Drug|5-Azacitidine|Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
16283450|NCT00766116|Drug|Gemtuzumab ozogamicin|Mylotarg given 2 times over 2 weeks
16283451|NCT00766103|Other|mild hypo- and hyperventilation|induction of mild hypo- and hypercarbia
16283452|NCT00766090|Drug|GW685698X|Inhaled Corticosteroid
16283453|NCT00766064|Drug|Paliperidone|"Paliperidone will be gradually increased to a final dose between 3 - 6 mg/day according to the following schedule:
~Weeks 1 - 3: 3 mg daily, Weeks 4 - 5: flexible dosing according clinical situation, dose range between 3 mg - 6 mg daily*, Week 6: fixed dose,
~*Criteria to increase the dose from 3 mg to 6 mg daily are 1] absence of any side effects, 2] patients not showing a sufficient response to 3 mg paliperidone can be increased to 6 mg daily. Response is defined as change in depression and anxiety ratings of at least 30% compared to baseline."
16283454|NCT00766051|Other|The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)|This study included a pre-feeding, feeding, and postural-respiratory protocol, given per the attending physician's order. The interventions were given daily when possible, and the infants FiO2 and heart rate, along with stress behaviors, were monitored prior to, during, and after the NBOTI. The intervention included parent education for feeding, handling, and interaction with their infant, along with nursing training during the feeding session. The occupational therapy investigator partnered with the parents and when the parents were not available, she partnered with the nursing staff.
16283455|NCT00766038|Drug|Recombinant human Growth Hormone|400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements
16283456|NCT00766038|Drug|Placebo|SC injection daily
16283457|NCT00766025|Drug|Rosuvastatin Calcium|single oral dose on days 1, 4, 5, 6, 10-16, 17
16283458|NCT00766012|Drug|AZD2066|Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel.
16283459|NCT00766012|Drug|Placebo|Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16.
16283460|NCT00765999|Drug|Linaclotide|Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
16283461|NCT00765986|Other|18F-FAZA|Radioactive dose of 110-600 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) of RT, then 4 weeks, 90 days and 12 months post-RT and upon logo-regional progression or recurrence.
16283462|NCT00765986|Other|18F-Fluorodeoxyglucose (18F-FDG)|Radioactive dose of 100-710 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) RT, then 4 weeks, 90 days, and 12 months post-RT, and upon loco-regional progression or recurrence.
16283463|NCT00765973|Drug|Topotecan Liposomes Injection (TLI)|TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
16283464|NCT00765973|Drug|Topotecan Liposomes Injection (TLI)|TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
16283465|NCT00765947|Drug|Aliskiren|Aliskiren 150 or 300 mg
16283466|NCT00765947|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 or 25 mg
16283467|NCT00765947|Drug|Amlodipine|Amlodipine 5 or 10 mg
16283468|NCT00765934|Drug|Rapydan|lidocaine / tetracaine 70/70 mg patch
16283469|NCT00765921|Drug|ranibizumab|Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).
16283470|NCT00765908|Device|Angioplasty balloon|90 second balloon inflation x 2
16283471|NCT00765908|Device|Angioplasty balloon|30 seconds or less balloon inflations x 2
16283472|NCT00765895|Drug|Nortriptyline Hydrochloride|Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
16283473|NCT00765895|Drug|Placebo (for nortriptyline)|Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;
16283474|NCT00765882|Drug|Linaclotide 290 micrograms|Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
16283475|NCT00765882|Drug|Linaclotide 145 micrograms|Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
16283476|NCT00765882|Drug|Placebo|Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
16283563|NCT00765206|Drug|omeprazole magnesium (20 mg equivalent)|Single dose of omeprazole magnesium per day for either 1 or 7 days.
16283477|NCT00765869|Other|Bowel cancer screening decision aid|A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)
16283478|NCT00765869|Other|Bowel cancer screening decision aid|A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)
16283479|NCT00765869|Other|Australian Government Bowel Cancer Screening booklet|A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program
16283480|NCT00765856|Drug|Oxymorphone ER|"Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
~Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications"
16283481|NCT00765843|Device|orthoses|orthoses are provided for use in standardized shoes that all subjects receive
16283482|NCT00765830|Drug|vildagliptin|50mg qd
16283483|NCT00765830|Drug|Placebo|qd
16283484|NCT00765817|Drug|placebo|subcutaneous injection, twice a day
16283485|NCT00765817|Drug|exenatide|subcutaneous injection, twice a day, 10mcg
16283486|NCT00765804|Drug|EGP-437 with EyeGate® II System|Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
16283487|NCT00765804|Drug|Sodium citrate buffer solution with EyeGate® II System|Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
16283488|NCT00765791|Procedure|Selective Neck Dissection Including Level IIB|Level IIB is dissected
16283489|NCT00765791|Procedure|Selective Neck Dissection Excluding Level IIB|Level IIB is not dissected
16283490|NCT00765765|Drug|hydroxychloroquine|Dose escalation from 200 mg po qd to 200 mg po bid.
16283491|NCT00765765|Drug|ixabepilone|Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.
16283492|NCT00765739|Other|Neuromuscular electrical stimulation|neuromuscular electrical stimulation that produce 40% of the maximum voluntary contraction
16283493|NCT00765739|Other|voluntary strengthening exercise|contracting the quadriceps muscle voluntarily to produce 40% of maximum voluntary contraction
16283494|NCT00765726|Biological|Moroctocog alfa(AF-CC)|Dosing is at the discretion of the investigator during the study
16283495|NCT00765726|Procedure|Blood draw for laboratory testing|Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies
16283496|NCT00765713|Device|Nasal continuous positive airway pressure|Nocturnal
16283497|NCT00765700|Drug|Topical Ketoprofen 10% Cream|Topical Administration
16283498|NCT00765700|Drug|Topical Placebo Cream|Topical Administration
16283499|NCT00765687|Drug|bisphosphates|any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
16283500|NCT00765674|Drug|Aliskiren|150 and 300 mg tablets
16283501|NCT00765674|Drug|Amlodipine|5 and 10 mg capsules
16283502|NCT00765674|Drug|Hydrochlorothiazide (HCTZ)|12.5 and 25 mg capsules
16283503|NCT00765674|Drug|Placebo|tablet
16283504|NCT00765674|Drug|Placebo|capsules
16283505|NCT00765661|Drug|Tacrolimus (Tacro™)|"The initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
~Other Names:
~Tacrolimus modified-release"
16283506|NCT00765661|Drug|Prograf|"Prograf® capsules, twice daily: Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
~Other name: tacrolimus"
16283507|NCT00765648|Drug|nicardipine intravenous|nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour
16283508|NCT00765648|Drug|Labetalol|Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.
16283509|NCT00765635|Drug|drops intilation (Taponoto ® )|four drops, unique doses
16283510|NCT00765635|Drug|drops intilation (Otocerum®)|four drops, unique doses
16283511|NCT00765635|Drug|drops intilation (Placebo)|Placebo
16283512|NCT00765596|Other|Liquid diet for 3 days|The control group were given a 3 -day liquid diet similar to the RYGB post-op diet
16283513|NCT00765583|Drug|Restylane|Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.
16283514|NCT00765570|Radiation|Spatially Fractioned Radiation Therapy|evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.
16283515|NCT00765570|Radiation|Treatment Group 1|one treatment of Grid therapy followed by 15 treatments with standard radiation
16283516|NCT00765570|Radiation|Standard radiation|15 Standard radiation treatments
16283517|NCT00765570|Radiation|Standard radiation|standard radiation treatment
16283518|NCT00765557|Drug|MiraLAX|Every subject will be given one bottle of the polyethylene glycol/placebo, divided into daily doses and depending on the patient's age, will be instructed to take 8.5 grams or 17 grams of the medication dispensed in daily dose vials to be mixed with water or juice. They will take the medication once a day for one month.
16283613|NCT00764881|Drug|Microgynon|Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.
16284228|NCT00760565|Drug|placebo|20mg/kg iv every 28 days for 3 infusions
16283519|NCT00765557|Drug|Placebos|Every subject will be given one bottle of the polyethylene glycol/placebo, divided into daily doses and depending on the patient's age, will be instructed to take 8.5 grams or 17 grams of the medication dispensed in daily dose vials to be mixed with water or juice. They will take the medication once a day for one month.
16283520|NCT00765544|Device|Anklebot|The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
16283521|NCT00765544|Device|Lokomat|The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .
16283522|NCT00765531|Radiation|Radiological testing|Bone mineral density
16283523|NCT00765531|Genetic|Pediatric Urologic DNA and History Repository|"All Stone Forming Patients and their families will undergo one of two groups of testing:
~Testing 1 - Involves completing an in-patient evaluation at University of Texas Southwestern for patients with hypercalciuria and their families.
~Testing 2 - Involves completing a simple out-patient evaluation for patients with or without hypercalciuria and their family members."
16283524|NCT00765518|Biological|Ixmyelocel-T|CRCs will be administered via direct injection into the heart muscle.
16283525|NCT00765518|Other|Standard of Care|Because the eligible patients had no other cardiac surgery or percutaneous cardiac interventions that were likely to produce clinical improvement, SOC was limited to pharmacologic therapy, heart transplant, or ventricular assist device therapy.
16283526|NCT00765505|Behavioral|Exercise Group|Sixteen week intervention where subjects will be progressed to four days per week for 45 minutes per session, 180 minutes minimum per week, of moderate intensity supervised exercise.
16283527|NCT00765505|Behavioral|Health Education Group|Sixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions
16283528|NCT00765492|Drug|AZD8529|oral
16283529|NCT00765492|Drug|Placebo|oral
16283530|NCT00765479|Dietary Supplement|soy protein isolate|Given orally
16283531|NCT00765479|Other|placebo|Given orally
16283532|NCT00765466|Drug|AVR118|daily doses of 4.0 mL AVR118 subcutaneously
16283533|NCT00765453|Other|Bone marrow derived progenitor cells or placebo infusion|Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
16283534|NCT00765453|Other|Placebo infusion|Placebo infusion
16283535|NCT00765440|Dietary Supplement|therapeutic nutritional supplementation|Given orally
16283536|NCT00765440|Other|placebo|Given orally
16283537|NCT00765427|Drug|QLT091001|7-day repeated dose
16283538|NCT00765414|Biological|Myozyme|30 mg/kg qow f and 40 mg/kg qow
16283539|NCT00765388|Device|SenSura Uro|The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
16283540|NCT00765388|Device|Hollister|The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive.
16283541|NCT00765375|Drug|Botulinum Neurotoxin Type A|1.5-3 units of Botox/lesion
16283542|NCT00765375|Drug|Bacteriostatic saline|.1 cc bacteriostatic saline/lesion
16283543|NCT00765362|Device|Encore Mobile-Bearing Knee|Used for primary total knee replacement
16283544|NCT00765336|Drug|minocycline extended release|1 mg/kg extended release minocycline HCL, once daily for 84 days.
16283545|NCT00765336|Drug|Placebo|placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
16283546|NCT00765323|Drug|Octreotide Implant|84 mg octreotide subcutaneous implant for 6 months
16283547|NCT00765323|Drug|Sandostatin LAR Depot|Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
16283548|NCT00765310|Dietary Supplement|R-alpha lipoic acid|600 mg in morning on empty stomach (two 300 mg capsules)
16283549|NCT00765310|Dietary Supplement|Placebo|two capsules once daily in morning on empty stomach
16283550|NCT00765297|Device|fall related movement (stumble) detector|movement pattern (gait,balance) of young subjects recovery of a stumble in young subjects
16283551|NCT00765297|Device|fall related movement characteristic (stumble) detector|age related gait changes influencing movement pattern different pattern to recover from a trip
16283552|NCT00765271|Drug|Abacavir|"Group 1 will be instructed to take • Abacavir 600 mg once daily (two 300 mg tablets once daily) as part of regular treatment throughout the whole study
~Group 2 will be instructed to take
~• Abacavir 600 mg once daily (two 300 mg tablets once daily) as part of regular treatment throughout the whole study"
16283553|NCT00765271|Drug|Darunavir/ritonavir|"Group 1 will be instructed to take
~• Three 300mg Darunavir tablets and one 100mg ritonavir tablet once a day for 14 days (on days 2 - 15)"
16283554|NCT00765271|Drug|Raltegravir|"Group 1 will be instructed to take • Two 200mg Raltegravir tablets twice daily for 14 days (on 16 - 29)
~Group 2 will be instructed to take
~• Two 200mg Raltegravir tablets twice daily for 14 days (on days 2-15)"
16283555|NCT00765245|Drug|Lenalidomide|Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
16283556|NCT00765245|Drug|Lenalidomide|Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
16283557|NCT00765245|Drug|Rituximab|Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.
16283558|NCT00765232|Drug|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
16283559|NCT00765232|Drug|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
16283560|NCT00765219|Behavioral|CBT|10-12 weekly sessions of CBT in person or over the telephone.
16283561|NCT00765219|Other|Usual Care|Treatment as usual provided by participants' physician(s)
16283562|NCT00765206|Drug|Omeprazole/sodium bicarbonate|Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
16283564|NCT00765193|Other|Inspection of covered areas|Clinicans performed a two-step examination for skin cancer, with clinical examination of individual lesions was aided by the use of dermoscopy, as needed. In the first step, physicians performed inspection of problem areas and uncovered areas only, and lesions suggestive of melanoma or non-melanoma skin cancer were noted. In the second step, TBSE was performed. Following both examinations, lesions suggestive of melanoma or non-melanoma skin cancer were excised or biopsied. Histopathologic diagnosis was recorded for each of the biopsied or excised lesions.
16283565|NCT00765180|Device|TRE vs. NBI|TRE NBI
16283566|NCT00765167|Drug|Fluoride|Brush half mouth twice daily for four days
16283567|NCT00765167|Drug|Triclosan|Brush half mouth daily for four days
16283568|NCT00765167|Drug|Chlorhexidine gluconate|Mouth rinsing with 15 ml for 30 seconds twice a day for four days
16283569|NCT00765167|Drug|Fluoride|Brush half mouth daily for four days
16283570|NCT00765154|Drug|darunavir|two 400mg tablets (800mg) once daily
16283571|NCT00765154|Drug|ritonavir|one 100mg capsule once daily
16283572|NCT00765128|Drug|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
16283573|NCT00765128|Drug|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
16283574|NCT00765115|Drug|LY450139|
16283575|NCT00765115|Drug|placebo|
16283576|NCT00765102|Drug|Bortezomib|"Bortezomib was administered at a dose of 1.0 mg/m^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin infusion.
~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
16283577|NCT00765102|Drug|Romidepsin|Romidepsin initially was administered at a dose of 10 mg/m^2 as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. Based on the occurrence of Grade 3 thrombocytopenia at this dose level, the dose was reduced by protocol amendment to 8 mg/m^2.
16283578|NCT00765089|Procedure|Isolation of pulmonary veins with Bipolar radiofrequency ablation|
16283579|NCT00765076|Biological|GSK Biologicals' influenza vaccine GSK2186877A|One intramuscular injection at Day 0
16283580|NCT00765076|Biological|GSK Biologicals' Fluarix|One intramuscular injection at Day 0
16283581|NCT00765063|Drug|Fragmin|Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
16283582|NCT00765050|Biological|CD133+ cells transplant|intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
16283583|NCT00765037|Device|Encore Reverse Shoulder Prosthesis|rotator cuff deficiency and glenohumeral arthritis
16283584|NCT00765024|Drug|Ivermectin|single dose of 200 mcg/kg
16283585|NCT00765024|Drug|ivermectin|two single dose of 200mcg/kg in 2 weeks
16283586|NCT00765024|Drug|Albendazole|Albendazole 7 days
16283587|NCT00765011|Drug|TPF, radiotherapy and cetuximab|3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
16283588|NCT00765011|Procedure|H&N surgery|Rescue surgery
16283589|NCT00764998|Biological|Fluviral|
16283590|NCT00764972|Drug|Sorafenib and Vinorelbine|"vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles);
~sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe."
16283591|NCT00764959|Device|Encore Linear™ Hip System|Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.
16283592|NCT00764946|Drug|Comparator: raltegravir|400 mg tablets taken twice daily. Total treatment period is 48 weeks.
16283593|NCT00764933|Behavioral|Structured information|Participants will receive structured information about their ICU-stay and course of therapy and care. They get information about procedures, sensory impressions and coping strategies. The intervention will last about 10 to 15 minutes depending on the state of the participant.
16283594|NCT00764933|Other|Unspecific conversation|Participants will receive a short conversation with the study personnel. This conversation will last about 10 to 15 minutes. No specific informations will be given about procedures, sensory impressions or coping strategies. Control intervention is designed to control for personal attention and care.
16283595|NCT00764920|Device|non-invasive imaging modalities for assessment of skin|skin imaging
16283596|NCT00764907|Drug|asparaginase|Given IV during reinduction
16283597|NCT00764907|Drug|cyclophosphamide|Given IV during reinduction
16283598|NCT00764907|Drug|cytarabine|Given IV during reinduction
16283599|NCT00764907|Drug|daunorubicin hydrochloride|Given IV during reinduction
16283600|NCT00764907|Drug|dexamethasone|Given IV or orally during reinduction
16283601|NCT00764907|Drug|doxorubicin hydrochloride|Given IV during reinduction
16283602|NCT00764907|Drug|etoposide|Given IV during reinduction
16283603|NCT00764907|Drug|ifosfamide|Given IV during reinduction
16283604|NCT00764907|Drug|leucovorin calcium|Given IV during reinduction
16283605|NCT00764907|Drug|mercaptopurine|Given orally during reinduction
16283606|NCT00764907|Drug|methotrexate|Given orally during reinduction
16283607|NCT00764907|Drug|prednisone|Given intrathecally during reinduction
16283608|NCT00764907|Drug|thioguanine|Given orally during reinduction
16283609|NCT00764907|Drug|vincristine sulfate|Given IV during reinduction
16283610|NCT00764907|Drug|vindesine|Given IV during reinduction
16283611|NCT00764894|Device|Foundation Knee|Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.
16283612|NCT00764881|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658ID)|Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose
16283614|NCT00764881|Drug|Placebo|Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.
16283615|NCT00764868|Drug|Lisdexamfetamine Dimesylate (LDX)|optimal dose of 30, 50 or 70 mg once daily
16283616|NCT00764855|Procedure|Automatic administration of propofol and opiates during routine clinical practice|"The clinical effect of administration of pharmaca can be measured in the changes of heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG. These measurements are performed standard, to secure the safety of the patient.
~The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of the patient.
~The blood pressure will be measured by non invasive blood pressure cuff around the arm and the respiration parameters will be measured by non invasive spirometry, which are all standard available on a anesthesia device."
16283617|NCT00764842|Device|Encore CLP® Hip stem|Subjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study.
16283618|NCT00764816|Other|grain (soy) protein diet|The patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian.
16283619|NCT00764816|Other|casein (meat) protein diet|The patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian.
16283620|NCT00764803|Device|Encore 3DKnee™ system|Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.
16283621|NCT00764803|Device|Encore MJS™ Knee System|Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.
16283622|NCT00764790|Biological|Fluarix|One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
16283623|NCT00764790|Biological|Fluzone|One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
16283624|NCT00764777|Device|iliac stenting|Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents
16283625|NCT00764764|Procedure|shoulder treatment|shoulder exercise, joint mobilization, home program, posture
16283626|NCT00764764|Procedure|Shoulder AND cervical treatment|Cervical and shoulder joint mobilization, exercise, posture, and home program
16283627|NCT00764751|Drug|LEO 19123 Cream (calcipotriol plus LEO 80122)|Once daily application
16283628|NCT00764751|Drug|Dovonex® cream|Twice daily application
16283629|NCT00764751|Drug|Cream vehicle|Twice daily application
16283630|NCT00764738|Device|OCT, Multifocal ERG, Microperimetry|"OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12.
~Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab.
~Multifocal ERG done at the same monthly visits as the microperimetry."
16283631|NCT00764738|Drug|Ranibizumab Ophthalmic|0.5 mg ranibizumab vs 2.0 mg ranibizumab
16283632|NCT00764725|Drug|conventional DMARD combination|MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
16283633|NCT00764725|Biological|MTX plus anti-TNF|MTX + infliximab; can be changed to MTX + etanercept within protocol
16283634|NCT00764712|Drug|insulin|Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
16283635|NCT00764699|Drug|rhIGF (Increlex)|rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.
16283636|NCT00764686|Other|Exercise and Education|One hydrotherapy class, one land-exercise class and one education session daily, for five days. Each exercise class and education session is one hour in duration.
16283637|NCT00764686|Other|Exercise and Education|Two hydrotherapy classes, one land-exercise class and one education session daily, for five days. Each exercise class and education are one hour in duration.
16283638|NCT00764673|Device|3DKnee|Subjects with knee osteoarthritis and willing to participate in the study
16283639|NCT00764660|Drug|SCH 900435|tablets
16283640|NCT00764660|Drug|Placebo|tablets
16283641|NCT00764647|Behavioral|Education program for family caregivers of frail elders|Family caregiver participants in the educational program will receive an educational course presented by the investigator that focuses on the care of the frail elder and themselves. The course will involve four to five consecutive weekly sessions, each 2 1/2 to 3 hours long. The educational program will be offered biannually, spring and fall seasons.
16283642|NCT00764634|Biological|Placebo (USP sterile saline for injection)|0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
16283643|NCT00764634|Biological|rBV A/B-40 vaccine|0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
16283644|NCT00764634|Biological|Placebo (USP sterile saline for injection)|0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
16283645|NCT00764634|Biological|rBV A/B-40 vaccine|0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
16283646|NCT00764621|Procedure|Primovist MRI|Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
16283647|NCT00764621|Procedure|Extracellular contrast media (ECCM) MRI|Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
16283648|NCT00764621|Procedure|Contrast-enhanced CT|Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
16283649|NCT00764595|Drug|imatinib mesylate|Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.
16283650|NCT00764582|Drug|1.5% levofloxacin ophthalmic solution|"Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group.
~Group 1: 30 minutes prior to surgery
~Group 2: 1 hour prior to surgery
~Group 3: 2 hours prior to surgery
~Group 4: 4 hours prior to surgery"
16283651|NCT00764582|Drug|0.5% moxifloxacin ophthalmic solution|"Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group.
~Group 5: 30 minutes prior to surgery
~Group 6: 1 hour prior to surgery
~Group 7: 2 hours prior to surgery
~Group 8: 4 hours prior to surgery"
16283652|NCT00764569|Device|Fluorescence/Elastic Scattering Spectroscopy|Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement
16283653|NCT00764556|Drug|Insulin|Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)
16283654|NCT00764543|Device|24-hour ambulatory blood pressure monitor|Patients will go home with the 24-hour ambulatory blood pressure monitor to be returned at the clinic after 24 hours.
16283655|NCT00764530|Device|Alumina/Alumina|CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell
16283656|NCT00764530|Device|Standard|Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head
16283657|NCT00764517|Drug|Cladribine|Given IV
16283658|NCT00764517|Other|Laboratory Biomarker Analysis|Correlative studies
16283659|NCT00764517|Biological|Rituximab|Given IV
16283660|NCT00764517|Drug|Vorinostat|Given PO
16283661|NCT00764504|Device|Reverse Shoulder Prosthesis|For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
16283662|NCT00764504|Device|Reverse Shoulder Prosthesis|For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
16283663|NCT00764491|Device|Structural Allograft Spacer|Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
16283664|NCT00764491|Device|OptiMesh 1500S|Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.
16283665|NCT00764478|Drug|Asenapine|asenapine tablet, 5 mg sublingually BID for 21 days
16283666|NCT00764478|Drug|Asenapine|asenapine tablet, 10 mg sublingually BID for 21 days
16283667|NCT00764478|Drug|Placebo|placebo sublingual tablet, administered BID for 21 days
16283668|NCT00764465|Drug|Maraviroc|300 mg BID
16283669|NCT00764465|Drug|Fosamprenavir|1400 mg BID, 700 mg BID or 1400 mg QD
16283670|NCT00764465|Drug|Ritonavir|100 mg BID, 100 mg QD
16283671|NCT00764439|Drug|Nicotine replacement therapy|Nicotine replacement therapy with Standard NRT user direction
16283672|NCT00764439|Drug|Nicotine replacement therapy|Nicotine replacement therapy with a Novel NRT user direction
16283673|NCT00764426|Drug|red wine, beer, ethanol|Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks
16283674|NCT00764426|Drug|de-alcoholised red wine, de-alcoholised beer, water|de-alcoholised red wine, de-alcoholised beer, water
16283675|NCT00764413|Drug|methylprednisolone|1 gram intravenous a day for 3 days
16283676|NCT00764413|Drug|Sodium chlorid|Sodium chlorid 9mg/ml 500 ml per day in 3 days
16283677|NCT00764400|Behavioral|Word Retrieval Treatments for Aphasia|Speech therapy sessions take place 4 times per week for up to 90 minutes per session. Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase. Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion.
16283678|NCT00764387|Drug|Gadovist® (Gadobutrol, BAY86-4875)|0,1 mmol/kg of body weight in the vein, single administration
16283679|NCT00764387|Drug|Dotarem|0,1 mmol/kg of body weight in the vein, single administration
16283680|NCT00764374|Drug|YM443|oral
16283681|NCT00764361|Drug|doxycycline|1.0% doxycycline gel applied topically to the wound once daily for 20 weeks
16283682|NCT00764361|Drug|placebo gel|placebo gel applied topically to the wound once daily for 20 weeks
16283683|NCT00764348|Other|no treatment|
16283684|NCT00764335|Procedure|total hip arthroplasty one side|unilateral total hip arthroplasty
16283685|NCT00764335|Procedure|total hip arthroplasty both sides|bilateral total hip arthroplasty
16283686|NCT00764322|Drug|tamoxifen citrate|Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
16283687|NCT00764322|Genetic|gene expression analysis|Genetic analysis of blood sample.
16283688|NCT00764322|Other|pharmacogenomic studies|Genetic analysis of blood sample.
16283689|NCT00764322|Other|questionnaire administration|Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
16283690|NCT00764322|Procedure|quality-of-life assessment|Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.
16283691|NCT00764309|Drug|dasatinib|Tablets, Oral, 100 mg, once daily, 6 months
16283692|NCT00764296|Other|no treatment|collection of samples of wound biofilm in Acute and Chronic Wounds
16283693|NCT00764296|Other|no treatment|collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds
16283694|NCT00764283|Device|Tegaderm dressing|Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia
16283695|NCT00764283|Device|Epi-Fix dressing|Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia
16283696|NCT00764283|Device|Lockit-Plus|Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia
16283697|NCT00764270|Dietary Supplement|R-alpha lipoic acid|300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks
16283698|NCT00764257|Device|PREVELLE Shape|
16283699|NCT00764257|Device|Restylane|
16283700|NCT00764244|Procedure|Vitrectomy|Vitrectomy
16283701|NCT00764244|Drug|Intravitreal triamcinolone injections|Intravitreal triamcinolone injections
16283702|NCT00764244|Procedure|Laser photocoagulation|Laser photocoagulation
16283703|NCT00764231|Behavioral|Home-based exercise program|Subjects will be given a personalized 12-week exercise program consisting of cardiovascular, musculoskeletal and flexibility exercises by a certified exercise physiologist. They will receive fitness assessments at baseline, 6 weeks and 12 weeks.
16283704|NCT00764231|Behavioral|Wait list|Subjects will have a 12-week waiting period, during which time they will be asked not to change their exercise habits. These subjects will receive the same fitness assessments as the experimental group (baseline, 6 weeks, 12 weeks), but will not receive an exercise program during the wait-list period. Following the 12-week wait-list period, subjects will be given the same home-based exercise intervention as the experimental group.
16283705|NCT00764218|Device|Positive airway pressure treatment|Positive airway pressure treatment as long as necessary
16283706|NCT00764218|Other|No positive airway pressure treatment|No treatment
16283707|NCT00764192|Procedure|blood sample|blood sample before and after a single HD
16283708|NCT00764192|Procedure|Flow-mediated dilation (FMD) before and after a single HD|measuring of the flow-mediated dilation using high-resolution ultrasound
16283709|NCT00764179|Other|milk enriched in proteins (2.15 g/100ml)|"Neonates will drink the hyperproteinic milk until they reach the 25th of Sempé and Pedron curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age)"
16283710|NCT00764179|Other|milk with normal protein concentration (1.45g/100ml)|"Neonates will drink the normoproteinic milk until they reach the 25th of Sempé and Pedron curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age)"
16283711|NCT00764166|Drug|Docetaxel + hormonal treatment (LH-RH agonist)|"Docetaxel will be administered:
~To D1 of every cycle in the dose of 70 mg/m²,
~Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance).
~Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally"
16283712|NCT00764166|Drug|Hormonal treatment (LH-RH agonist)|Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.
16283713|NCT00764153|Procedure|Bipolar hemiarthroplasty|Lateral approach. FWB.
16283714|NCT00764153|Procedure|Internal fixation|Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
16283715|NCT00764140|Biological|tumor growth factor concentration|spot urine or blood collection will be used to measure specific tumor growth factor
16283716|NCT00764114|Drug|antibiotic|6 or 12 weeks
16283717|NCT00764101|Behavioral|Attentional Bias Modification|computerized training to reduce attentional bias in posttraumatic stress disorder
16283718|NCT00764075|Device|Beutel TM|application of BeutelTM
16283719|NCT00764075|Other|standard|standard procedure will be applied but no Beutel TM software
16283720|NCT00764075|Device|software Beutel TM|application of BeutelTM to patients data for determination of site of latest contraction
16283721|NCT00764062|Drug|Amoxicillin|Amoxicillin :drug
16283722|NCT00764049|Device|Single pass albumin dialysis|6 hours sessions of albumin dialysis.
16283723|NCT00764036|Drug|artesunate|add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
16283724|NCT00764010|Dietary Supplement|No dietary counseling and omega-3 capsules|Omega-3 2.4 g/day
16283725|NCT00764010|Dietary Supplement|Omega-3 capsules and dietary counseling|Omega-3 2.4 g/day and Mediterranean-like diet
16283726|NCT00764010|Dietary Supplement|Dietary counseling, placebo capsules for omega-3|Mediterranean-like diet
16283727|NCT00763997|Drug|dipyrone|Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward
16283728|NCT00763997|Drug|Ibuprofen|Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day
16283729|NCT00763997|Drug|Acetaminophen|Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day
16283730|NCT00763997|Drug|Acetaminophen|Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day
16283731|NCT00763997|Drug|Parecoxib/Valdecoxib|40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day
16283732|NCT00763997|Other|Blood samples|Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
16283733|NCT00763984|Behavioral|Usual Care|This group will receive routine care, however, it is possible that that control condition participants will receive Pelvic Floor Muscle Training (PFMT) instruction from their health care providers. We will monitor control women's knowledge, adoption and maintaining of PFMT.
16283734|NCT00763984|Behavioral|Bladder Health class|Modeled on our intervention with older women, Bladder Health Class (BH Class) will include Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The BT instructions will be modified for this pregnant group. We will monitor control women's knowledge, adoption and maintaining of PFMT and BT.
16283735|NCT00763971|Drug|Lisdexamfetamine Dimesylate (LDX)|30, 50 or 70mg capsule once per day (Overencapsulated)
16283736|NCT00763971|Drug|Methylphenidate Hydrochloride|18, 36, or 54mg tablet one per day (Overencapsulated)
16283737|NCT00763971|Drug|Placebo|Placebo capsule once per day (Overencapsulated)
16283738|NCT00763958|Drug|Placebo|Placebo to match buprenorphine administered for 3 months
16283739|NCT00763958|Drug|Buprenorphine|Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
16283740|NCT00763945|Other|data collection|The data of patients is collected from their hospital documentation The follow-up of all patients is done via phone calls in order to collect data about the outcome of each patient
16283741|NCT00763932|Biological|Myozyme|10 mg/kg or 20 mg/kg qw OR 20 mg/kg or 40 mg/kg qow
16283742|NCT00763919|Behavioral|Psychoeducation module|The psychoeducation module will use psychological and medication education to address opposition to prophylaxis, denial of illness severity or therapeutic effectiveness, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment over medications or in relation to the use of complementary or alternative treatments.
16283743|NCT00763919|Behavioral|Substance abuse module|The substance abuse module will address problematic substance abuse, particularly as it relates to medication adherence.
16283790|NCT00763555|Drug|Vehicle (placebo)|placebo spray, twice a day for 8 weeks
16283744|NCT00763919|Behavioral|Improved communication/rapport with provider module|The provider communication and rapport module will improve health care provider communication to address fear of side effects, concern regarding change in appearance, or side effect-related distress.
16283745|NCT00763919|Behavioral|Medication routines management module|The medication routines management module will develop strategies and behaviors that help create medication adherence routines for those who have difficulties with medication routines or experience outside opposition to medications.
16283746|NCT00763906|Device|norepinephrine infused at the clinician's discretion|
16283747|NCT00763906|Device|norepinephrine infused under computerized fuzzy logic control|
16283748|NCT00763893|Drug|placebo|Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.
16283749|NCT00763893|Drug|Losartan|50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg
16283750|NCT00763880|Drug|Lidocaine|2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block.
16283751|NCT00763880|Drug|Saline|Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.
16283752|NCT00763867|Drug|Placebo|
16283753|NCT00763867|Drug|Sildenafil|
16283754|NCT00763841|Device|Transcranial magnetic stimulation|Stimulation will be given daily at a particular site for three days a week
16283755|NCT00763841|Device|Sham|
16283756|NCT00763828|Device|Life Recovery Systems ThermoSuit|Hypothermia induction (cooling to 32 to 34 degrees C core temperature) using the Life Recovery Systems ThermoSuit System (a device which cools patients using direct skin contact with cold water) followed by PCI (percutaneous coronary intervention) and maintenance of hypothermia for 3 hours following PCI.
16283757|NCT00763815|Drug|Lixisenatide (AVE0010)|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16283758|NCT00763815|Drug|Placebo|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16283759|NCT00763815|Device|Pen auto-injector|
16283760|NCT00763815|Drug|Pioglitazone|Dose to be kept stable.
16283761|NCT00763815|Drug|Metformin|Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.
16283762|NCT00763789|Other|local anaesthesia and remifentanil sedation|
16283763|NCT00763789|Other|total intravenous anaesthesia|
16283764|NCT00763776|Device|clamp crushing technique|Liver transection during hepatectomy by clamp crushing technique
16283765|NCT00763776|Device|ultrasonic dissector|Liver transection during hepatectomy by the ultrasonic dissector
16283766|NCT00763763|Drug|Imatinib mesylate|imatinib 600 mg/day for 2 years
16283767|NCT00763763|Drug|Interferon|45 micrograms per week during 2 years
16283768|NCT00763763|Drug|Vincristine|2 mg IV injection repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation
16283769|NCT00763763|Drug|Dexamethasone|40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation
16283770|NCT00763750|Drug|PPX +TMZ+XRT|PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
16283771|NCT00763737|Procedure|Fetoscopic Endoluminal Tracheal Occlusion|prenatal balloon placement at 30-31+6 weeks and removal at 34-34+6 wks
16283772|NCT00763711|Device|Needle Guided Periurethral Injection|Bulking Agent injection using a needle guide
16283773|NCT00763698|Device|QuickFlex Micro Model 1258T Left Heart Lead|Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
16283774|NCT00763685|Drug|etoricoxib|etoricoxib 120 mg, paracetamol 1 g
16283775|NCT00763672|Other|Transmission of sFlt-1 results to the investigator|Transmission of sFlt-1 results by the laboratory to the investigator
16283776|NCT00763672|Other|No transmission of the sFlt-1 results to the investigator|The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.
16283777|NCT00763659|Dietary Supplement|Lutein/ Zeaxanthin + Omega-3-FA|20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
16283778|NCT00763659|Dietary Supplement|Lutein/ Zeaxanthin + Omega-3-FA|10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
16283779|NCT00763659|Dietary Supplement|Placebo|0 mg Lutein, Zeaxanthin, Omega-3-FA
16283780|NCT00763646|Drug|Taxotere, Cisplatin, and 5-FU|Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total), 1 - 2 weeks, Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total)
16283781|NCT00763633|Drug|vitamin B6|high dose of vitamin B6
16283782|NCT00763633|Drug|vitamin B6|low vitamin B6
16283783|NCT00763620|Device|catheter for mini bronchoalveolar lavage|For each patient included an endotracheal aspiration and a mini bronchoalveolar lavage will be performed. After local anaesthesia, a suction catheter will be introduced in trachea by nasotracheal way. An endotracheal aspirate will be performed. Then, the mini bronchoalveolar lavage will be performed with the specific catheter introduced through the suction catheter. Expectorated sputum will also be ordered. This procedure will be performed once at the admission patient in intensive care unit.
16283784|NCT00763607|Genetic|Protein expression by immunohistochemistry and immunofluorescence|Protein expression by immunohistochemistry and immunofluorescence
16283785|NCT00763594|Behavioral|Brief Relational Therapy|16 weeks of psychodynamically informed and therapy alliance focussed psychotherapy adapted for treating Major Depressive Disorder.
16283786|NCT00763594|Behavioral|Interpersonal Psychotherapy|16 weeks of Interpersonal Psychotherapy for Major Depressive Disorder
16283787|NCT00763568|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
16283788|NCT00763568|Biological|Peginterferon alfa-2a|One nitazoxanide 500 mg tablet orally twice a day for 4 weeks followed by one nitazoxanide 500 mg tablet orally twice a day plus weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
16283789|NCT00763555|Drug|CD 2027|3 µg/g Oily Spray, twice a day for 8 weeks
16283791|NCT00763542|Behavioral|CBT for SUD|CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.
16283792|NCT00763542|Behavioral|Structured writing therapy for PTSD|Patients progress through three stages, in which instructions for writing and feedback by therapists are successively aimed at achieving trauma processing, cognitive restructuring and social sharing of a traumatic event.
16283793|NCT00763529|Drug|Mometasone|Mometasone furoate cream 0.1% applied once daily
16283794|NCT00763529|Drug|Fluticasone|Fluticasone propionate cream 0.05% applied twice daily
16283795|NCT00763516|Radiation|Proton radiation and chemotherapy|"Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only
~Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks
~Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation
~Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses"
16283796|NCT00763503|Drug|CD 2027|3µg/g Oily Spray
16283797|NCT00763490|Procedure|Full intensity, double umbilical cord, stem cell transplant|stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation
16283798|NCT00763490|Drug|Flu/Bu4 conditioning regimen|"Fludarabine: 40 mg/m² daily on days -5, -4, -3, -2
~Busulfan: 3.2 mg/kg IV daily on days -5, -4, -3, -2"
16283799|NCT00763490|Radiation|Total Lymphoid Irradiation (TLI)|one dose, 400 cGy,on day -1 or day 0, prior to cord blood infusion
16283800|NCT00763490|Drug|Graft versus Host Disease prevention (GVHD prophylaxis)|Tacrolimus for GVHD (Graft Versus Host Disease Prevention) Tacrolimus - will begin on day -3 (IV or oral) for at least 180 days. Target trough level for tacrolimus is 8-12 ng/ml. In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant.
16283801|NCT00763490|Drug|Mycophenolate Mofetil|"Mycophenolate Mofetil (MMF) for GVHD prophylaxis. MMF - will be given at a dose of 10mg/kg IV q 8 hours if the patient weight is more than 50 kg, or 15 mg/kg IV q 8 hours if less than 50 kg, beginning the morning of day -3. (If renal failure and Glomerular Filtration Rate (GFR) < 25 mL/min, the dose should not exceed 1 gm every 8 hours. (No dose adjustment for liver disease is required.) MMF should be given via IV until oral medications are tolerated.
~MMF will be stopped at Day +28 if no acute GVHD is seen by that time. If there is not any donor cell engraftment, MMF will be continued as directed by the attending physician. If the patient has active acute GVHD requiring systemic therapy, MMF may be continued."
16283802|NCT00763477|Biological|ghrelin|subcutaneous injection
16283803|NCT00763464|Procedure|stress-echocardiography|stress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue)
16283804|NCT00763464|Procedure|stress-MRI|stress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist)
16283805|NCT00763451|Drug|Lixisenatide (AVE0010)|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16283806|NCT00763451|Drug|Placebo|Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
16283807|NCT00763451|Device|Pen auto-injector|
16283808|NCT00763451|Drug|Metformin|Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.
16283809|NCT00763438|Drug|Sertindole|Flexible dose
16283810|NCT00763425|Procedure|cold polypectomy|The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
16283811|NCT00763425|Procedure|conventional polypectomy|The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.
16283812|NCT00763412|Drug|placebo|CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
16283813|NCT00763412|Drug|repaglinide|CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
16283814|NCT00763399|Dietary Supplement|probiotics (antibiophilus(Lactobacillus casei), bio-three)|probiotics (antibiophilus(Lactobacillus casei), bio-three) 4x 10^8CFU/day
16283815|NCT00763386|Device|NexGen LPS-Flex Fixed Bearing Knee|NexGen LPS-Flex Fixed Bearing femoral component
16283816|NCT00763386|Device|NexGen Legacy Posterior Stabilized Knee|NexGen Legacy Posterior Stabilized femoral component
16283817|NCT00763373|Other|Implementation of antibiotic switch guidelines|Implementation of antibiotic switch guidelines
16283818|NCT00763360|Device|DisCoVisc®|Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
16283819|NCT00763360|Drug|Healon|Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
16283820|NCT00763360|Drug|Amvisc Plus|Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure
16283821|NCT00763347|Drug|SYR-619|SYR-619 12.5 mg, tablets, orally, once daily for up to 12 weeks.
16283822|NCT00763347|Drug|SYR-619|SYR-619 50 mg, tablets, orally, once daily for up to 12 weeks.
16283823|NCT00763347|Drug|SYR-619|SYR-619 100 mg, tablets, orally, once daily for up to 12 weeks.
16283824|NCT00763347|Drug|SYR-619|SYR-619 200 mg, tablets, orally, once daily for up to 12 weeks.
16283825|NCT00763347|Drug|Placebo|SYR-619 placebo-matching tablets, orally, once daily for up to 12 weeks.
16283826|NCT00763347|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
16283827|NCT00763321|Drug|ABT-712|ABT-712 extended-release tablet
16283828|NCT00763321|Drug|Placebo|Placebo tablet
16283829|NCT00763308|Behavioral|Web-based Heart Healthy Program|The Heart Healthy program will be developed during the course of the study based on goals set by researchers and based on feedback from focus groups. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease.
16283830|NCT00763295|Other|T-Spot.TB test|diagnostic test
16283869|NCT00763048|Drug|Fluoride, triclosan|Brush twice daily
16283870|NCT00763035|Drug|Regadenoson|Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.
16283831|NCT00763282|Behavioral|Self Management (SM)|Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
16283832|NCT00763282|Behavioral|Motivational Interviewing (MI)|Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.
16283833|NCT00763282|Behavioral|Education (ED)|The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
16283834|NCT00763269|Drug|Triclosan, Silicon dioxide, fluoride|Brush twice daily
16283835|NCT00763269|Drug|Triclosan, fluoride|Brush twice daily
16283836|NCT00763256|Drug|Triclosan, Fluoride|subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
16283837|NCT00763256|Drug|Fluoride|subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
16283838|NCT00763243|Behavioral|Cogmed Working Memory Training Program|The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success.
16283839|NCT00763230|Device|Transcranial direct current stimulation|tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.
16283840|NCT00763204|Drug|AN2728 Cream, 2%|
16283841|NCT00763204|Drug|AN2728 Cream, 1%|
16283842|NCT00763204|Drug|AN2728 Cream, 0.3%|
16283843|NCT00763204|Drug|AN2728 Cream Vehicle|
16283844|NCT00763204|Drug|Betnesol®-V Creme, 0.1%|
16283845|NCT00763191|Other|examination of ocular movements|
16283846|NCT00763191|Other|MATTIS test|
16283847|NCT00763191|Other|UPDRS test|
16283848|NCT00763191|Other|CRST test|
16283849|NCT00763178|Drug|Duloxetine|"Dosage given according to the following schedule:
~Week 1: 30mg QD, Week 2: 60mg QD, Week 3: 60mg QD, Week 4-6: Flexible dosing according to clinical situation, dose range between 60-120mg QD, Weeks 7 + 8: fixed dose"
16283850|NCT00763165|Drug|Triclosan|Brush twice daily
16283851|NCT00763165|Drug|Fluoride|Brush twice daily
16283852|NCT00763165|Drug|Fluoride|Brush twice daily
16283853|NCT00763152|Other|Observation of transponder stability|Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
16283854|NCT00763139|Drug|Pioglitazone|45 mg by mouth once a day for 8 weeks
16283855|NCT00763139|Drug|Placebo|By mouth once a day for 8 weeks
16283856|NCT00763126|Behavioral|stress level|Stress levels
16283857|NCT00763113|Device|Vanguard PS Knee|Vanguard PS Knee
16283858|NCT00763113|Device|Vanguard CR Knee|Vanguard CR Knee
16283859|NCT00763087|Behavioral|weightbearing exercise|All subjects in the exercise group will participate, as able, in 3 supervised 1 hour exercise sessions per week for the first month and 2 supervised and 1 unsupervised exercise session per week for the remaining 2 months. Subjects in each exercise group will be seen on alternating times to avoid cross contamination of treatment intervention. Walking intensity for all subjects will be applied with the intent to exceed their routine physical stress level, and therefore incur positive adaptations to physical stress, but not exceed their threshold for injury.
16283860|NCT00763087|Behavioral|nonweightbearing exercise|All subjects in the 2 exercise groups will participate, as able, in 3 supervised 1 hour exercise sessions per week for the first month and 2 supervised and 1 unsupervised exercise session per week for the remaining 2 months. Subjects in each exercise group will be seen on alternating times to avoid cross contamination of treatment intervention. Biking intensity for all subjects will be applied with the intent to exceed their routine physical stress level, and therefore incur positive adaptations to physical stress, but not exceed their threshold for injury.
16283861|NCT00763087|Behavioral|nonexercising control|All subjects will be instructed, verbally and with written documents, regarding appropriate foot and skin care twice per month.
16283862|NCT00763074|Behavioral|Standard life style modification for type 2 diabetes|"Two session of education for exercise and diet.
~----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30~35kcal/day"
16283863|NCT00763074|Behavioral|Diet restriction|"Education for diet and exercise every 2 weeks
~----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day"
16283864|NCT00763074|Behavioral|Exercise|"Education for diet and exercise every 2 weeks
~----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day"
16283865|NCT00763074|Behavioral|Diet and exercise|"Education for diet and exercise every 2 weeks
~----------- Exercise education like as exercise group and diet education like as diet group"
16283866|NCT00763061|Drug|Travoprost 0.004% Ophthalmic Solution (Travatan)|Travoprost at 9 AM + Placebo & 9 PM
16283867|NCT00763061|Drug|Timolol 0.5% Ophthalmic Solution (Timoptic)|Timolol in each eye, twice daily at 9 AM & 9 PM
16283868|NCT00763048|Drug|Fluoride|Brush twice daily for 6 weeks
16283871|NCT00763035|Drug|Dobutamine|Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
16283872|NCT00763022|Drug|TAK-559|TAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.
16283873|NCT00763022|Drug|TAK-559|TAK-559 32 mg, tablets, orally, once daily for up to 26 weeks.
16283874|NCT00763022|Drug|Placebo|TAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
16283875|NCT00763009|Drug|dipyridamole|0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
16283876|NCT00762996|Device|etafilcon A|contact lens
16283877|NCT00762996|Device|omafilcon A|contact lens
16283878|NCT00762983|Drug|loratadine|"Claritin Tablet 10 mg, Claritin RediTabs 10 mg: For pediatric patients aged 7 years and older, 10 mg of loratadine is orally administered once daily after a meal in usual cases.
~Claritin Dry Syrup 1%: For pediatric patients aged 3 to < 7 years, 5 mg loratadine (0.5 g dry syrup); and for pediatric patients aged 7 years and older, 10 mg of loratadine (1 g dry syrup) is dissolved immediately before use and orally administered once daily after a meal in usual cases.
~The observation period will not be specified."
16283879|NCT00762970|Device|Test Lens 1|Investigational soft contact lens with asperic optical design to control myopia progression.
16283880|NCT00762970|Device|Test Lens 2|Investigational soft contact lens with asperic optical design to control myopia progression.
16283881|NCT00762970|Device|Control Lens|Spectacle Lenses.
16283882|NCT00762957|Drug|TAK-559 and metformin|TAK-559 16 mg, tablets, orally, once daily and metformin stable dose orally, once daily for up to 26 weeks.
16283883|NCT00762957|Drug|TAK-559 and metformin|TAK-559 32 mg, tablets, orally, once daily and metformin stable dose, orally, once daily for up to 26 weeks.
16283884|NCT00762957|Drug|Metformin|TAK-559 placebo-matching tablets, orally, once daily and metformin stable dose, orally, once daily for up to 26 weeks.
16283885|NCT00762931|Device|Resolve Stimulator and Proximity Lead|An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
16283886|NCT00762918|Dietary Supplement|cholecalciferol|cholecalciferol 5000 IU capsule by mouth daily for 3 months
16283887|NCT00762905|Device|LiquiBand Laparoscopic|LiquiBand Laparoscopic™ is a sterile, liquid adhesive made up of a blend of n-butyl and 2-octyl cyanoacrylate intended for soft tissue approximation of skin wounds. It is packaged in a sterile, single-use, nylon applicator with internal glass ampoule containing 0.8g of adhesive and sealed in a PETG/Tyvek blister pack. LiquiBand Laparoscopic™ is intended to be applied topically to pre-apposed wound edges. The tissue adhesive sets rapidly (5 - 10 seconds) to hold the wound closed. Following wound closure the product is designed to apply a broad coverage of adhesive to act as a liquid dressing to protect the wound.
16283888|NCT00762905|Device|Dermabond|High viscosity DermaBond Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use applicator packaged in a blister pouch. The applicator is comprised of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes.
16283889|NCT00762892|Drug|Raltegravir and truvada|Raltegravir 400 mg po bid, truvada 1 tab q daily
16283890|NCT00762892|Drug|Atazanavir, Norvir and Truvada|Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
16283891|NCT00762853|Drug|Fluoride|Brush half mouth once with assigned study treatment
16283892|NCT00762853|Drug|Fluoride and triclosan|Brush half mouth once with assigned study treatment
16283893|NCT00762840|Device|the Apexum Protocol|using the apexum kit for minimally invasive removal of periapical lesion tissue.
16283894|NCT00762840|Procedure|Conventional endodontic procedure|Standard root canal treatment
16283895|NCT00762814|Device|Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)|Eligible subjects will be perform walking tests involving the use of the TENS device (Select Unit by Empi) on the lower leg bilaterally during gait: uncued (wearing the unit but, but with the device turned off) or with a tactile cue (wearing the device with it turned on until a tactile stimulus is felt). The TENS unit is a battery-operated, single-channel electrical stimulator worn around the proximal calf that can used to provide a constant tactile stimulus. All subjects will undergo a single visit in which the two walking conditions are tested. During these visits, the patient will perform the same gait assessments measured with the device turned off as well as turned on. Testing the two conditions on the same day/time will provide the investigators with a consistent comparison of the two tested conditions, as mobility and function in patients with PD can vary significantly within and between days.
16283896|NCT00762788|Device|senofilcon A|1 week extended wear contact lens
16283897|NCT00762788|Device|lotrafilcon A|1 week extended wear contact lens
16283898|NCT00762788|Device|lotrafilcon B|1 week extended wear contact lens
16283899|NCT00762788|Device|balafilcon A|1 week extended wear contact lens
16283900|NCT00762788|Device|comfilcon A|1 week extended wear contact lens
16283901|NCT00762788|Device|etafilcon A|1 week extended wear contact lens
16283902|NCT00762775|Dietary Supplement|Calcium and vitamin D supplementation|Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.
16283903|NCT00762762|Drug|Triclosan and fluoride|Brush twice daily
16283904|NCT00762762|Drug|Fluoride|swished twice daily
16283905|NCT00762749|Drug|diphenhydramine HCl|A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule
16283906|NCT00762736|Drug|Pioglitazone and azilsartan|Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.
16283907|NCT00762736|Drug|Pioglitazone and azilsartan|Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 40 mg, tablets, orally, once daily for up to 24 weeks.
16283908|NCT00762736|Drug|Pioglitazone|Pioglitazone 15 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.
16283909|NCT00762736|Drug|Pioglitazone and azilsartan|Pioglitazone 45 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.
16284048|NCT00761696|Drug|IPI-926|Oral daily dosing
16284304|NCT00759863|Behavioral|Lifezig|Personalized Reminiscence Video
16283910|NCT00762736|Drug|Pioglitazone and azilsartan|Pioglitazone 45 mg, tablets, orally, once daily and azilsartan 40 mg, tablets, orally, once daily for up to 24 weeks.
16283911|NCT00762736|Drug|Pioglitazone|Pioglitazone 45 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.
16283912|NCT00762723|Device|Trinica Anterior Lumbar Plate System|Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.
16283913|NCT00762710|Drug|Prazosin medication|"Form: Prazosin will be taken orally, in the form of pills.
~Dosing: 9 AM, 3 PM, 9 PM
~Days 1-2: 0 mg, 0 mg, 1 mg
~Days 3-4: 1 mg, 1 mg, 1 mg
~Days 5-7: 2 mg, 2 mg, 2 mg
~Day 8-10: 2 mg, 2 mg, 6 mg
~Day 11-14: 4 mg, 4 mg, 6 mg
~Day 15-84: 4 mg, 4 mg, 8 mg"
16283914|NCT00762710|Drug|Placebo medication|"Form: Placebo will be taken orally, in the form of pills.
~Dosing: 9 AM, 3 PM, 9 PM
~Days 1-2: 0 mg, 0 mg, 1 mg
~Days 3-4: 1 mg, 1 mg, 1 mg
~Days 5-7: 2 mg, 2 mg, 2 mg
~Day 8-10: 2 mg, 2 mg, 6 mg
~Day 11-14: 4 mg, 4 mg, 6 mg
~Day 15-84: 4 mg, 4 mg, 8 mg"
16283915|NCT00762684|Drug|TAK-559|TAK-559 32 mg, tablets, orally, once daily for up to 26 weeks.
16283916|NCT00762684|Drug|Placebo|TAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
16283917|NCT00762671|Drug|Ebselen|150 mg BID for 2 weeks
16283918|NCT00762671|Drug|Placebo|Placebo 1 po BID for 2 weeks
16283919|NCT00762658|Drug|AN2728 Ointment, 5%|
16283920|NCT00762658|Drug|AN2728 Ointment, 2%|
16283921|NCT00762658|Drug|AN2728 Ointment, 0.5%|
16283922|NCT00762658|Drug|AN2728 Ointment Vehicle|
16283923|NCT00762658|Drug|Betnesol®-V Creme, 0.1%|
16283924|NCT00762658|Drug|Protopic® Ointment, 0.1 %|
16283925|NCT00762645|Drug|Travoprost 0.004% (Travatan)|One drop in each eye, once daily at 9 AM
16283926|NCT00762645|Drug|Pilocarpine 1%|One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
16283927|NCT00762632|Drug|NILOTINIB|400 mg Nilotinib bid (total daily dose 800 mg) should be continued 25 weeks
16283928|NCT00762632|Drug|EVEROLIMUS|Everolimus at 2,5 mg/day should be continued 25 weeks.
16283929|NCT00762619|Drug|Fluoride|Brush twice daily
16283930|NCT00762619|Drug|Triclosan, fluoride|Brush twice daily
16283931|NCT00762606|Procedure|Phacoemulsification cataract extraction surgery|Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
16283932|NCT00762606|Procedure|Small incision cataract surgery|Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
16283933|NCT00762593|Device|transvaginal placebo device|Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
16283934|NCT00762593|Device|transvaginal electrical stimulation device|Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
16283935|NCT00762567|Drug|phenylephrine HCl|A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
16283936|NCT00762554|Drug|Depodur|Depodur 10mg given epidurally at end of cesarean section.
16283937|NCT00762554|Drug|Depodur|Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.
16283938|NCT00762554|Drug|Fentanyl|Epidural fentanyl infusion started after epidural lidocaine or spinal bupivacaine used for the cesarean section.
16283939|NCT00762541|Device|MEL 80 Treatment of High Myopia|The reduction or elimination of myopia > -7.00 D to -12.00 D, and astigmatism less than or equal to -6.00 D at the spectacle plane (myopia with or without astigmatism), with a maximum MRSE ≤ -12.00 D.
16283940|NCT00762528|Drug|Triclosan/Copolymer/fluoride toothpaste|Twice daily usage
16283941|NCT00762528|Drug|Sodium monofluorophosphate toothpaste|Twice daily usage
16283942|NCT00762515|Drug|Fluoride|Brush teeth two times daily for 6 weeks
16283943|NCT00762515|Drug|Triclosan|Brush two times daily for 6 weeks
16283944|NCT00762515|Drug|Fluoride|Brush two times daily for 6 weeks
16283945|NCT00762502|Device|senofilcon A toric contact lens|soft contact lens
16283946|NCT00762502|Device|balafilcon A toric contact lens|soft contact lens
16283947|NCT00762489|Other|Temporal artery thermometer temperature|Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.
16283948|NCT00762476|Drug|3804-250A|"topical product
~apply 2 pumps
~apply at least every 4 hours or after hand washing"
16283949|NCT00762476|Drug|3804-291|"topical
~apply 2 pumps
~apply at least every 4 hours or after hand washing"
16283950|NCT00762463|Drug|Celecoxib|capsule, 200 mg QD, 6-12 weeks
16283951|NCT00762463|Drug|Diclofenac SR|tablet, 75 mg QD,6-12 weeks
16283952|NCT00762450|Drug|Triclosan, Fluoride|Rinse 3 times daily with assigned toothpaste slurry
16283953|NCT00762450|Drug|fluoride|Rinse 3 times daily with assigned toothpaste slurry
16283954|NCT00762450|Drug|Fluoride, triclosan, amino acid|Rinse 3 times daily with assigned toothpaste slurry
16283955|NCT00762437|Device|Zeltiq Dermal Cooling Device|Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
16283956|NCT00762424|Drug|Flowmax|0.4 mg once a day until stone passage total = 9 tablets
16283957|NCT00762424|Drug|placebo|cornstarch
16283958|NCT00762411|Drug|LY450139|Administered orally once daily.
16283959|NCT00762411|Drug|Placebo|Administered orally once daily.
16283960|NCT00762398|Device|Masimo hemoglobin-meter|Placing a probe on the finger
16283961|NCT00762398|Biological|drawing blood sample|drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)
16283962|NCT00762385|Device|galyfilcon A|galyfilcon A
16283963|NCT00762385|Device|comfilcon A|comfilcon A
16283964|NCT00762372|Drug|desflurane|volatile liquid for inhalation
16283965|NCT00762372|Drug|desflurane/nitrous oxide|volatile liquid for inhalation with gas for inhalation
16283966|NCT00762372|Drug|sevoflurane/nitrous oxide|volatile liquid for inhalation and gas for inhalation
16283967|NCT00762359|Drug|Lansoprazole|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
16283968|NCT00762359|Drug|Gefarnate|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
16283969|NCT00762346|Drug|zometa|zometa 4mg i.v. every 4 weeks for up to 2 years
16283970|NCT00762320|Drug|Low dose Kaletra tablets|Lopinavir/Ritonavir tablets 100mg/25mg
16283971|NCT00762307|Device|Zeltiq Dermal Cooling Device|Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
16283972|NCT00762281|Device|MEL 80 Hyperopic LASIK Treatment|Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.
16283973|NCT00762268|Drug|SAMe|"SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
16283974|NCT00762268|Drug|Placebo|
16283975|NCT00762255|Drug|Vorinostat|Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
16283976|NCT00762255|Drug|Bevacizumab|Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
16283977|NCT00762255|Drug|Irinotecan|Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.
16283978|NCT00762242|Procedure|blood sampling and brachial artery ultrasound|"Intravenous blood sampling will be performed before and 15 seconds, 30 seconds, 1,2,5,10,and 30 minutes following an ischemic stimulus (inflation of a blood pressure cuff to suprasystolic pressure for 5 minutes)
~Brachial artery ultrasound imaging will be performed before and 1 minute after a 5 minute ischemic stimulus, to assess endothelium-dependent vasodilation of the brachial artery.
~Following completion of blood sampling, an additional resting image of the brachial artery will be obtained. Sub-lingual nitroglycerin will be administered, and the artery will be imaged again after 3 minutes, to assess endothelium-independent vasodilation."
16283979|NCT00762229|Drug|Ezetimibe 10 mg|Ezetimibe 10 mg daily for 4 weeks
16283980|NCT00762229|Drug|Ezetimibe 5 mg|"Ezetimibe 5 mg daily for 4 weeks, formulated as a 10 mg tablet split in half"
16283981|NCT00762216|Device|AcrySof® Toric intraocular lens|Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery
16283982|NCT00762190|Drug|TAK-559 and insulin|TAK-559 32 mg, tablets, orally, once daily and insulin stable dose injection for up to 54 weeks.
16283983|NCT00762190|Drug|Insulin|TAK-559 placebo-matching, tablets, orally, once daily and insulin stable dose injection for up to 54 weeks.
16283984|NCT00762177|Drug|Fluoride|Brush twice a day for 14 days
16283985|NCT00762177|Drug|Fluoride, Triclosan|Brush twice daily for 14 days
16283986|NCT00762177|Drug|Stannous Fluoride|Brush twice daily for 14 days
16283987|NCT00762164|Drug|Vytorin|Vytorin 10/80 split into 4
16283988|NCT00762164|Drug|Simvastatin|Simvastatin 20 milligrams
16283989|NCT00762151|Other|Negative Control (Regular Toothpaste)|Regular Toothpaste
16283990|NCT00762151|Other|Positive Control (anti-plaque/anti-bacterial toothpaste)|Standard anti-plaque and anti-bacterial toothpaste
16283991|NCT00762151|Drug|Prototype (AN0128 Toothpaste)|AN0128 Toothpaste
16283992|NCT00762138|Device|AutoloGel System|"The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:
~Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects with diabetic ulcers Bowel and bladder care for subjects with pressure ulcers at risk for contamination Management of underlying disease"
16283993|NCT00762125|Behavioral|CR+ST|Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
16283994|NCT00762125|Behavioral|ET|Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
16283995|NCT00762125|Behavioral|AC treatment|Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal
16283996|NCT00762112|Drug|TAK-559|TAK-559 32 mg, tablets, orally, once daily for up to 24 months.
16283997|NCT00762099|Drug|Pregabalin|Pre-operative dose 150 mg Post-operative dose 75 mg BID
16283998|NCT00762099|Drug|Placebo|Placebo/sugar tabs will look identical to active drug.
16283999|NCT00762086|Device|AngioPress Intermittent pneumatic compression (IPC) Device|Treatment with Intermittent pneumatic compression (IPC) for PAD
16284000|NCT00762086|Other|Medications and Standard walking exercises|Aspirin/Clopidegrol and Standard walking exercises
16284001|NCT00762073|Drug|budesonide|oral suspension
16284002|NCT00762073|Drug|placebo|oral suspension matching budesonide
16284003|NCT00762060|Device|ON-Q Silver soaker System|Continuous infusion of local anesthetic to surgical site
16284004|NCT00762060|Drug|Patient controlled analgesia|IV opioids delivered via PCA
16284005|NCT00762047|Device|Durasphere FI|Durasphere Injection
16284006|NCT00762047|Device|Sham|Sham injection with anesthesia
16284007|NCT00762034|Drug|Pemetrexed|Induction therapy 500 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
16284008|NCT00762034|Drug|Pemetrexed|Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
16284009|NCT00762034|Drug|Paclitaxel|Induction therapy 200 mg/m^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
16284010|NCT00762034|Drug|Carboplatin|Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
16284011|NCT00762034|Biological|Bevacizumab|Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
16284179|NCT00760903|Other|MR spectroscopy (MRS)|
16284012|NCT00762034|Biological|Bevacizumab|Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
16284013|NCT00762021|Device|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
16284014|NCT00762021|Device|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.
16284015|NCT00761995|Drug|Azopt|topical eye drop dosed 1 drop 3 times daily
16284016|NCT00761995|Drug|Cosopt|topical eye drop dosed 1 drop 2 times daily
16284017|NCT00761982|Procedure|Infusion on autologous CD34+ stem cells into middle cerebral artery|Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients
16284018|NCT00761969|Other|Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice|Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.
16284019|NCT00761956|Device|NexGen CR-Flex Fixed Bearing Knee|NexGen CR-Flex Fixed Bearing femoral component
16284020|NCT00761956|Device|NexGen CR Knee|NexGen Complete Knee Solution Cruciate Retaining femoral component
16284021|NCT00761930|Drug|Fluoride|Brush twice daily
16284022|NCT00761930|Drug|Triclosan and fluoride|Brush twice daily
16284023|NCT00761930|Drug|Herbal Ingredient and fluoride|Brush twice daily
16284024|NCT00761917|Device|Tear Film Analyzer|tear film images
16284025|NCT00761904|Behavioral|Free Generic Samples (hydrochlorothiazide, simvastatin)|Free samples of generic hydrochlorothiazide (12.5 mg tabs) and simvastatin (20 mg tabs)
16284026|NCT00761891|Other|Chewable aspirin|chewable aspirin 81mg daily for 2 weeks
16284027|NCT00761878|Procedure|Exposure to plasma energy|Non-invasive exposure to pulsed plasma to the unbroken skin over half of the facial area
16284028|NCT00761865|Device|Air Cast Stirrup Brace & High Tide Fracture Boot|Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.
16284029|NCT00761852|Drug|Ruboxistaurin|32 mg daily for 2 weeks
16284030|NCT00761852|Drug|Placebo|1 tab po QD for 2 weeks
16284031|NCT00761839|Behavioral|After-care summary|"The wound care NP will measure the wound and assess adherence to the following self-management activities: visiting the wound care clinic as scheduled; offloading; applying dressings; obtaining assistance at home; and participating in social activities. This information will be entered into a computer database on a VA computer that will generate a summary chart showing the relationship between adherence and wound healing. The generated after-care summary will be discussed with the patient and used to set self-management goals."
16284032|NCT00761839|Behavioral|Control group|Patients in the control group will receive usual counseling for self-management.
16284033|NCT00761826|Device|MEL 80 Mixed Astigmatism Treatment|Treatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.
16284034|NCT00761813|Device|Open reduction internal fixation (ORIF) with single sliding hip screw|The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
16284035|NCT00761813|Device|ORIF with multiple cancellous screws|ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
16284036|NCT00761800|Drug|Lactic acid|
16284037|NCT00761774|Drug|Brivaracetam|Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
16284038|NCT00761761|Drug|Sensoril|
16284039|NCT00761761|Other|Placebo|
16284040|NCT00761748|Device|Convatec Uro 2-piece|"Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'.
~The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look."
16284041|NCT00761748|Device|SenSura Uro 2-piece|SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
16284042|NCT00761735|Biological|Peginterferon alfa-2b|In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).
16284043|NCT00761735|Drug|Ribavirin|In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).
16284044|NCT00761722|Drug|azacitidine|"Arm 1:
~Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
~Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
~Arm 2:
~All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle."
16284045|NCT00761709|Drug|AL-39256 Ophthalmic Suspension, 1%|
16284046|NCT00761709|Drug|Latanoprost Ophthalmic Solution, 0.005%|
16284047|NCT00761709|Drug|Vehicle|Inactive ingredients used as a placebo comparator
16284049|NCT00761670|Drug|amisulpride and risperidone|amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day
16284050|NCT00761657|Drug|FG-4592|FG-4592 1.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284051|NCT00761657|Drug|FG-4592|FG-4592 1.5 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284052|NCT00761657|Drug|FG-4592|FG-4592 2.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284053|NCT00761657|Drug|FG-4592|FG-4592 2.5 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284054|NCT00761657|Drug|FG-4592|FG-4592 3.0 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284055|NCT00761657|Drug|FG-4592|Placebo Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284056|NCT00761657|Drug|FG-4592|FG-4592 0.7 mg/kg Two times weekly dosing for 29 days or Three Times weekly dosing for 26 days
16284057|NCT00761644|Drug|Doxil|Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
16284058|NCT00761644|Drug|Bevacizumab|Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
16284059|NCT00761644|Drug|Temsirolimus|Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
16284060|NCT00761631|Biological|13 valent pneumococcal conjugate vaccine|Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
16284061|NCT00761618|Procedure|Intrapleural catheter (IPC) drained|IPC drained daily (Group 1) or 3 times per week (Group 2)
16284062|NCT00761618|Procedure|IPC Placement|IPC placed in chest cavity to drain excess fluid
16284063|NCT00761618|Radiation|Chest X-Ray|Chest X-Rays at 3 and 6 month follow up visits
16284064|NCT00761605|Drug|Paliperidone|Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
16284065|NCT00761592|Biological|Botulinum Toxin Type A 900kDa|6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
16284066|NCT00761592|Biological|Botulinum Toxin Type A 150kDa|6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
16284067|NCT00761579|Drug|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
16284068|NCT00761566|Other|Real preconditioning followed by Sham preconditioning|Subjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure. The subjects will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg.
16284069|NCT00761566|Other|Sham preconditioning followed by Real preconditioning|Subjects in this arm of the study will first receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a sham procedure consisting of inflating the blood pressure cuff to 10 mmHg. They will then cross-over to the other arm of the study and receive four 5 minute cycles of upper limb ischemia interspaced with 5 minutes of reperfusion by using a blood-pressure cuff inflated to a pressure of 15 mmHg greater than systolic arterial pressure.
16284070|NCT00761553|Other|Dietary supplements with exercise|Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
16284071|NCT00761553|Dietary Supplement|Dietary supplement without exercise|Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.
16284072|NCT00761540|Drug|liraglutide|Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
16284073|NCT00761540|Drug|placebo|Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
16284074|NCT00761540|Drug|liraglutide|Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
16284075|NCT00761540|Drug|placebo|Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
16284076|NCT00761540|Drug|liraglutide|Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
16284077|NCT00761540|Drug|placebo|Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)
16284078|NCT00761527|Drug|Desloratadine Syrup|"Desloratadine (Aerius) Syrup;
~Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
16284079|NCT00761514|Drug|Humira (adalimumab)|40 mg eow
16284080|NCT00761501|Drug|PN400|Oral
16284081|NCT00761501|Drug|Naproxen (Proxen S)|Oral
16284082|NCT00761501|Drug|Naproxen (Naprosyn E)|Oral
16284083|NCT00761488|Device|AcrySof® Toric IOL|Implanted into the study eye
16284084|NCT00761475|Procedure|mesh supported closure|onlay mesh supported closure midline laparotomy
16284085|NCT00761475|Procedure|primary closure|primary closure of the midline
16284086|NCT00761475|Procedure|mesh supported closure|sublay mesh supported closure midline laparotomy
16284087|NCT00761462|Drug|Ciprofloxacin|Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
16284088|NCT00761462|Drug|Non-quinolone antibiotic|Common used dose and route
16284089|NCT00761449|Drug|lenalidomide|Initial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks.
16284090|NCT00761436|Biological|Spheramine (BAY86-5280)|Stereotactic Intrastriatal Implantation
16284091|NCT00761423|Biological|PRP Injection with eccentric exercises|PRP Injection with eccentric exercises
16284092|NCT00761423|Biological|Placebo Injection with eccentric exercises|Placebo Injection with eccentric exercises
16284180|NCT00760903|Other|MR Diffusion Tensor Imaging (DTI)|
16284093|NCT00761410|Device|P.F.C. Sigma RP-F Total Knee Replacement|An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design
16284094|NCT00761397|Behavioral|Interview|15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises
16284095|NCT00761397|Behavioral|Phone Call|Phone call follow ups for 4 weeks after last radiation treatment
16284096|NCT00761397|Other|Brochure|Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises
16284097|NCT00761397|Other|Questionnaire|Day 1 of study, 10 weeks after starting study, & 12 months after starting study
16284098|NCT00761384|Drug|90Y-ibritumomab|90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
16284099|NCT00761371|Drug|Imiquimod 5% cream|Subjects were treated with imiquimod (one sachet/20 cm2), three applications per week, for up to 16 weeks, or fewer in the case of total clearance of initial warts. At the visit at the end of treatment, a second scraping of the lesion area was carried out to determine the sub-type of HPV.
16284100|NCT00761358|Drug|Z-338|Oral
16284101|NCT00761358|Drug|Placebo|Oral
16284102|NCT00761345|Drug|gemcitabine|gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
16284103|NCT00761345|Drug|Erlotinib|Erlotinib 100mg or 150mg daily of each 21 day cycle
16284104|NCT00761345|Radiation|low dose fractionated radiotherapy|low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
16284105|NCT00761332|Drug|teriparatide|treatment will be prescribed according to usual standard of care
16284106|NCT00761332|Drug|antiresorptives|treatment will be prescribed according to usual standard of care
16284107|NCT00761319|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.
16284108|NCT00761319|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.
16284109|NCT00761306|Drug|Vortioxetine (Lu AA21004)|5 or 10 mg/day; tablets; orally
16284110|NCT00761280|Drug|trabedersen|
16284111|NCT00761280|Drug|temozolomide|
16284112|NCT00761280|Device|Drug delivery system for administration of AP 12009|Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
16284113|NCT00761280|Procedure|Placement of Drug Delivery System|Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
16284114|NCT00761280|Drug|carmustine|
16284115|NCT00761280|Drug|lomustine|
16284116|NCT00761267|Drug|Anidulafungin|"Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).
~Maximum treatment duration with anidulafungin is 35 days."
16284117|NCT00761267|Drug|Fluconazole|Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days.
16284118|NCT00761254|Drug|Domperidone|Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.
16284119|NCT00761241|Drug|Gemcitabine, Docetaxel, 5FU, Oxaliplatin|Gemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation
16284120|NCT00761241|Biological|Alpha-interferon|Alpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy
16284121|NCT00761241|Radiation|Abdominal/pelvic radiation therapy|3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46
16284122|NCT00761241|Procedure|Pancreaticoduodenectomy|Surgery performed if subject is considered candidate by protocol definition.
16284123|NCT00761228|Drug|Apomorphine|Patients will receive an ascending dosing schedule of continuous subcutaneous apomorphine to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day.
16284124|NCT00761228|Drug|Placebo|Patients will receive a continues subcutaneous infusion of saline solution.
16284125|NCT00761215|Drug|TR-701 200 mg|oral TR-701 200 mg for 5 to 7 days
16284126|NCT00761215|Drug|TR-701 300 mg|oral TR-701 300 mg for 5 to 7 days
16284127|NCT00761215|Drug|TR-701 400 mg|TR-701 400 mg for 5 to 7 days
16284128|NCT00761202|Drug|A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®|Eyedrops as required, but at least 3 times per day
16284129|NCT00761202|Drug|Sodium hyaluronate|Eyedrops as required, but at least 3 times per day
16284130|NCT00761189|Drug|Paliperidone|Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
16284131|NCT00761176|Device|The Provant Therapy System|The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
16284181|NCT00760890|Dietary Supplement|Fer-In-Sol (ferrous sulfate)|7.5 mg/day in the form of 0.3 ml once each day
16284182|NCT00760890|Dietary Supplement|Iron fortified cereal|1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
16284183|NCT00760877|Drug|Nilotinib|Supplied in 200 mg capsules
16284184|NCT00760877|Drug|Imatinib|Supplied in 100 mg and 400 mg capsules
16284185|NCT00760864|Drug|TAK-715 and methotrexate|TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
16284587|NCT00757731|Drug|Placebo|hard capsule
16284132|NCT00761163|Other|Resistance Exercise|The subjects will complete 2 resistive exercise sessions on non-consecutive days that will be supervised by our laboratory staff. The following exercises will be performed using the Keiser Sports Health equipment in Ismail Health, Exercise, and Nutrition Center: seated row, double leg press, seated leg curl, chest press, and leg extension. The subjects will individually perform 3 sets of 8-10 repetitions at an exercise intensity of 70% of pre-determined maximal strength for these exercises. Each repetition will be performed in a slow (six to eight seconds) uniform fashion, giving equal time to the concentric (muscle shortening) and eccentric (muscle lengthening) portions. One minute of rest will be allowed between sets. The last repetition of the third set of each exercise will be done to voluntary fatigue or the performance of 12 repetitions.
16284133|NCT00761163|Other|Aerobic Exercise|The subjects will complete 2 aerobic exercise sessions on non-consecutive days that will also be supervised by our laboratory staff. The subjects will perform 45 minutes of aerobic exercise on a stationary bike at an exercise intensity of 70% of their heart-rate reserve.
16284134|NCT00761163|Other|Control (Non-exercise)|The subjects will also complete 2 non-exercise sessions on non-consecutive days that will also be supervised by our laboratory staff. These sessions will consist of incorporating diversionary tasks throughout a 45 minute period consisting of a variety of motor and psychological tasks (tests of hand steadiness, alertness, optical illusions, mental acuity, etc.)
16284135|NCT00761150|Drug|ABT-712|ABT-712 extended-release tablet
16284136|NCT00761150|Drug|Placebo|Placebo tablet
16284137|NCT00761137|Drug|0.3 mg tropicamide|0.3 mg tropicamide in intra-oral thin film
16284138|NCT00761137|Drug|1 mg tropicamide|1 mg tropicamide in intra-oral thin film
16284139|NCT00761137|Drug|3 mg tropicamide|3 mg tropicamide in intra-oral thin film
16284140|NCT00761137|Drug|0 mg tropicamide|0 mg tropicamide (placebo) in intra-oral thin film
16284141|NCT00761124|Behavioral|Intervention Session|A one-hour discussion group composed of 8-10 Latino men. The session includes an interactive, multimedia presentation led by a facilitator to guide participant interaction.
16284142|NCT00761124|Behavioral|Printed Material|General prostate cancer pamphlet
16284143|NCT00761111|Behavioral|Assessment of the Your Back Operation|to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy
16284144|NCT00761098|Drug|Standard Care|Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
16284145|NCT00761098|Drug|Experimental|25% Salt Poor Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure.
16284146|NCT00761085|Drug|Morphine|Standard of care for pain management of acute episode of pain
16284147|NCT00761085|Drug|Methadone|Compare to standard of care for pain management of acute episode of pain
16284148|NCT00761059|Drug|Glucose 20%|The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
16284149|NCT00761059|Drug|Aqua|The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning
16284150|NCT00761033|Behavioral|music|
16284151|NCT00761020|Drug|Mefloquine|To determine the seroconversion rate (sensitivity) to Plasmodium falciparum Merozoite Surface Protein 1 (Pf MSP-1) antigen by ELISA assay in the infectivity control and mefloquine cohorts as part of a larger project to support the qualification of anti-MSP-1 antigen-specific antibody assays as valid surrogate endpoints for malaria infection.
16284152|NCT00761020|Other|Control|No Intervention
16284153|NCT00761007|Drug|Ibodutant|Oral tablet, dose level 1 (10 mg), once daily
16284154|NCT00761007|Drug|Ibodutant|Oral tablet, dose level 2 (30 mg), once daily
16284155|NCT00761007|Drug|Ibodutant|Oral tablet, dose level 3 (60 mg), once daily
16284156|NCT00761007|Drug|Placebo|Oral tablet matching the three dose levels of ibodutant, once daily
16284157|NCT00760994|Behavioral|Experiential acceptance|The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004).
16284158|NCT00760994|Behavioral|Cognitive restructuring|The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).
16284159|NCT00760994|Other|No-intervention control: Nutrition information|The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.
16284160|NCT00760981|Drug|Imatinib|The single cohort for this study will receive 2 dose levels of imatinib, 200 mg orally daily followed by 400 mg orally daily.
16284161|NCT00760968|Drug|TAK-783 and methotrexate|TAK-783 100 mg, tablets, orally, once daily and methotrexate stable dose therapy for up to 12 weeks.
16284162|NCT00760968|Drug|Methotrexate|TAK-783 placebo-matching tablets, orally, once daily and methotrexate stable dose therapy for up to 12 weeks.
16284163|NCT00760955|Drug|TAK-583|TAK-583 5 mg, tablets, orally, once daily for up to 6 months.
16284164|NCT00760955|Drug|TAK-583|TAK-583 50 mg, tablets, orally, once daily for up to 6 months.
16284165|NCT00760955|Drug|TAK-583|TAK-583 100 mg, tablets, orally, once daily for up to 6 months.
16284166|NCT00760955|Drug|Placebo|TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
16284167|NCT00760942|Dietary Supplement|Similac special care 30|Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.
16284168|NCT00760942|Dietary Supplement|Similac human milk fortifier|Powdered human milk fortifier.
16284169|NCT00760929|Drug|Placebo|iv 9mg/kg weekly
16284170|NCT00760929|Drug|Placebo|iv 16mg/kg every 3 weeks
16284171|NCT00760929|Drug|RG1507|iv 9mg/kg weekly
16284172|NCT00760929|Drug|RG1507|iv 16mg/kg every 3 weeks
16284173|NCT00760929|Drug|erlotinib [Tarceva]|150mg oral daily
16284174|NCT00760916|Drug|UT-15C 1 mg|UT-15C 1 mg
16284175|NCT00760916|Drug|UT-15C 0.25 mg|UT-15C 0.25 mg
16284176|NCT00760916|Drug|UT-15C 5 mg|UT-15C 5 mg
16284177|NCT00760916|Drug|Placebo|Placebo
16284178|NCT00760903|Other|Conventional MRI of the brain|
16284186|NCT00760864|Drug|TAK-715 and methotrexate|TAK-715 50 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
16284187|NCT00760864|Drug|TAK-715 and methotrexate|TAK-715 100 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
16284188|NCT00760864|Drug|Methotrexate|TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks
16284189|NCT00760851|Other|probiotic strain Bb-12|10^9 CFU Bb-12 per 4 oz yogurt
16284190|NCT00760851|Other|no Bb-12|yogurt identical to intervention yogurt, only without Bb-12 added.
16284191|NCT00760838|Drug|Azithromycin 250 mg|Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
16284192|NCT00760838|Drug|Placebo|Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
16284193|NCT00760825|Biological|killed bivalent (O1 and O139)whole cell oral cholera vaccine|1.5 ml given twice orally, 14 days apart
16284194|NCT00760812|Behavioral|Early Social Interaction Project- PII|The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
16284195|NCT00760812|Behavioral|Early Social Interaction Project- IES|The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
16284196|NCT00760799|Procedure|Discectomy with anular repair|Comparison of discectomy with and without repair to the anulus fibrosus of the intervertebral disc
16284197|NCT00760786|Drug|Intensive lipid lowering plus Omega3-fatty acid|Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd
16284198|NCT00760786|Drug|Moderate lipid lowering plus Omega3-fatty acid|atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd
16284199|NCT00760786|Drug|Intensive lipid lowering plus placebo|atorvastatin 40mg qd
16284200|NCT00760786|Drug|Moderate lipid lowering plus placebo|atorvastatin 10mg qd
16284201|NCT00760773|Drug|Lacidophil (experimental high dose)|Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days.
16284202|NCT00760773|Drug|Lacidophil (experimental standard dose)|Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days.
16284203|NCT00760773|Drug|Placebo|The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated.
16284204|NCT00760760|Drug|reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)|4g daily, 8 weeks
16284205|NCT00760760|Drug|control|equivalent amount of fat as butter
16284206|NCT00760747|Drug|Atomoxetine|1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
16284207|NCT00760734|Drug|Low pressure hyperbaric oxygen therapy|HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
16284208|NCT00760734|Drug|Low pressure hyperbaric oxygen therapy|HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
16284209|NCT00760721|Behavioral|Educational Small Group Session|1 hour small group health-related discussion
16284210|NCT00760695|Drug|dronabinol|tablets, twice daily, for 4 weeks
16284211|NCT00760695|Drug|placebo|tablets, twice daily, for 4 weeks
16284212|NCT00760682|Procedure|Hyperbaric oxygen|30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.
16284213|NCT00760669|Drug|Infliximab; observational study|This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
16284214|NCT00760669|Drug|Methotrexate; observational study|Participants with RA will receive methotrexate based on physician's clinical judgement.
16284215|NCT00760630|Device|FFR/CFR and IVUS|All patients with clinical indication for cardiac cath will have FFR and IVUS
16284216|NCT00760617|Biological|GSK Bio's influenza vaccine GSK2186877A|Intramuscular (IM) administration, 1 dose
16284217|NCT00760617|Biological|Fluarix|Intramuscular (IM) administration, 1 dose
16284218|NCT00760604|Procedure|Esophagectomy|Comparison of en-bloc vs. non-en bloc esophagectomy
16284219|NCT00760578|Drug|Placebo|Once daily, oral
16284220|NCT00760578|Drug|Pioglitazone|Once daily, oral
16284221|NCT00760578|Drug|MSDC-0160 90 mg|Once daily, oral
16284222|NCT00760578|Drug|MSDC-0160 220 mg|Once daily, oral
16284223|NCT00760565|Drug|RO4905417|3mg/kg iv every 28 days for 3 infusions
16284224|NCT00760565|Drug|RO4905417|20mg/kg iv every 28 days for 3 infusions
16284225|NCT00760565|Drug|RO4905417|7mg/kg iv every 28 days for 3 infusions
16284229|NCT00760552|Other|High Intensity Intervention|High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.
16284230|NCT00760552|Other|Low Intensity Intervention|Low intensity group will receive management by their PCP and a 3-part intervention that was effective in a recent VA study. This one-time intervention will occur 3 months after completion of the initial 6-month pharmacist intervention and will include: Provider education including an email message to re-evaluate the specific patient's BP regimen and a web link to the VA/JNC-7 hypertension guidelines. 1-time patient-specific computerized alert reminding the PCP of the goal BP, values of the patient's last 3 BP assessments, & possible options for medication changes if BP does not remain at goal. Patient education including a personalized letter with information on strategies to improve BP control, including medication adherence, Dietary Approaches to Stop Hypertension (DASH) diet/exercise. The letter will note that many patients require more than one medication and will provide a link to the VA patient education web library and American Heart Association (AHA) site.
16284231|NCT00760552|Other|All- 6 month pharmacist intervention|All patients will receive the initial 6-month pharmacist intervention. The intervention: 1) co-management of HTN by pharmacists can improve BP control; and 2) active follow-up is needed to reinforce progress and proactively identify and resolve problems. The intervention will include structured visits at baseline 1, 2, 4, and 6 months after baseline and telephone calls at 2 weeks and between the visits. At baseline, the pharmacist will review the computerized patient record system (CPRS) medical record and perform a structured interview, including: a detailed medication history of all prescription and non-prescription therapies; an assessment of patient knowledge of all meds, the purpose of each med, medication dosages and timing, and potential side effects; potential contraindications to specific medications; and expectations for future dosage changes and of the need for future monitoring potential barriers to BP control.
16284232|NCT00760539|Drug|Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution|
16284233|NCT00760539|Drug|Travoprost 0.004%/Timolol 0.5% ophthalmic solution|
16284234|NCT00760526|Device|Continuous glucose monitor|Daily use of a continuous glucose monitor
16284235|NCT00760526|Device|Home blood glucose monitor|Home monitoring 3 or more times a day
16284236|NCT00760513|Drug|OMACOR|4 grammes daily, oral capsule
16284237|NCT00760513|Drug|Placebo oral capsule|4 grammes daily, oral capsule (olive oil)
16284238|NCT00760500|Other|Nasopharyngeal Swab|Nasopharyngeal Swab
16284239|NCT00760487|Device|AcrySof Toric IOL|Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments
16284240|NCT00760474|Drug|Pregabalin, then placebo|Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
16284241|NCT00760474|Drug|Placebo, then pregabalin|Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
16284242|NCT00760461|Drug|Domperidone|10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
16284243|NCT00760448|Drug|insulin detemir|
16284244|NCT00760448|Drug|insulin NPH|
16284245|NCT00760435|Drug|Infliximab|5 mg/kg IV over 2 hours once
16284246|NCT00760435|Drug|Placebo|Placebo (same volume as active drug)
16284247|NCT00760422|Device|NIR|Thermometer
16284248|NCT00760396|Drug|VGX-1027|Subjects will
16284249|NCT00760383|Dietary Supplement|Essential amino acids|Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session.
16284250|NCT00760383|Dietary Supplement|Alanine|Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session.
16284251|NCT00760370|Drug|Zoledronic Acid|4 mg intravenous (iv), one treatment
16284252|NCT00760344|Drug|SYR-472|SYR-472 3.125 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
16284253|NCT00760344|Drug|SYR-472|SYR-472 12.5 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
16284254|NCT00760344|Drug|SYR-472|SYR-472 50 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
16284255|NCT00760344|Drug|SYR-472|SYR-472 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
16284256|NCT00760344|Drug|Placebo|SYR-472 placebo-matching tablets, orally, once daily with lifestyle modification and/or metformin therapy for up to 12 weeks.
16284257|NCT00760344|Drug|Sitagliptin|Sitagliptin 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
16284258|NCT00760318|Drug|Keppra|There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID.
16284259|NCT00760305|Behavioral|Pro self pain control programme|A 6 week psychoeducational programme that included three home visits and three phone calls. Patients were taught about pain medication and side effects and about incorrect information regarding cancer pain management
16284260|NCT00760279|Drug|Azithromycin|
16284261|NCT00760266|Drug|Aliskiren|Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks
16284262|NCT00760266|Drug|Hydrochlorothiazide|Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks
16284303|NCT00759876|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with milk. Dosing based on participant body weight
16284263|NCT00760227|Other|Massage Therapy|Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
16284264|NCT00760227|Other|Humor Therapy|For this component will will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
16284265|NCT00760227|Other|Relaxation Therapy|In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
16284266|NCT00760214|Drug|Azilsartan medoxomil|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
16284267|NCT00760214|Drug|Azilsartan medoxomil|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
16284268|NCT00760214|Drug|Ramipril|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
16284269|NCT00760188|Device|Cementless Oxford Partial Knee|Cementless Oxford Partial Knee Replacement
16284270|NCT00760175|Biological|Vaxigrip (Aventis-Pasteur Canada)|The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.
16284271|NCT00760149|Drug|Rifampicin in higher doses|Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
16284272|NCT00760136|Procedure|Computed Tomography|CT imaging of bilateral knee
16284273|NCT00760123|Other|Early Physical Therapy and Educational strategy|"Experimental group:
~physical therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and Educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors,etc.
~Other: control group: only the educational strategy"
16284274|NCT00760110|Device|blood pressure measurements based on HBP or CBP|To clarify which of HBP or CBP provides the stronger predictive power for the outcomes, the 400 patients were classified as with or without hypertension based on HBP and CBP measurements at baseline
16284275|NCT00760097|Device|Transcranial direct stimulation|sessions of 20 minutes each
16284276|NCT00760084|Drug|Decitabine|Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).
16284277|NCT00760058|Device|AcrySof® IQ IOL|Replacement of natural crystalline lens in cataract surgery
16284278|NCT00760058|Device|Tecnis® Aspheric intraocular lens|Replacement of natural crystalline lens in cataract surgery
16284279|NCT00760058|Device|Akreos® MI60 intraocular lens|Replacement of natural crystalline lens in cataract surgery
16284280|NCT00760045|Drug|Hydroxypropyl Guar Galactomannan|One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
16284281|NCT00760045|Drug|0.1% sodium hyaluronate ophthalmic solution|One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
16284282|NCT00760032|Drug|Ciprofloxacin|Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
16284283|NCT00760032|Drug|Placebo|Placebo capsules, one capsule per day during four weeks.
16284284|NCT00760019|Drug|salsalate|1.5 grams orally 3 times daily
16284285|NCT00760019|Drug|placebo|matching placebo
16284286|NCT00760006|Drug|Unasyn|Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for this study is off-label as with the majority of antibiotics used with children. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
16284287|NCT00760006|Other|saline solution|Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.
16284288|NCT00759993|Drug|chromium piccolinate|1000mg tab
16284289|NCT00759993|Drug|placebo for chromium piccolinate|
16284290|NCT00759967|Procedure|Microneurography|Muscle sympathetic nerve activity measurement will be obtained using microneurography. Approximately 10-20% of microneurography recordings are not interpretable due to technical problems. For this reason, blood samples will be collected at the same time that the microneurography is to be done. These test will be done at 3 time points throughout the study.
16284291|NCT00759967|Procedure|Bioimpedance testing|bioimpedance measurement of extracellular fluid volume will be measured at the end of each 3 month period. This test will be done at 3 time points throughout the study.
16284292|NCT00759954|Drug|morphine sulfate sustained-release capsules|1 x 200 mg, single-dose capsule
16284293|NCT00759954|Drug|KADIAN (morphine sulfate sustained-release) capsules|2 x 100 mg, single-dose capsule
16284294|NCT00759941|Drug|Brinzolamide 1% ophthalmic solution (Azopt)|One drop three times a day in both eyes for 3 months
16284295|NCT00759941|Drug|Placebo eye drops|One drop three times a day in both eyes for 3 months
16284296|NCT00759941|Drug|Latanoprost 0.005% ophthalmic solution (Xalatan)|One drop once a day in both eyes for 3 months
16284297|NCT00759928|Drug|Erlotinib|150 mg once daily by mouth
16284298|NCT00759928|Drug|Sorafenib|400 mg twice daily by mouth
16284299|NCT00759915|Drug|morphine sulfate extended-release capsules|2 x 10 mg, single-dose capsule
16284300|NCT00759915|Drug|KADIAN (morphine sulfate extended-release) capsules|1 x 20 mg, single-dose capsule
16284301|NCT00759902|Drug|morphine sulfate extended-release capsules|2 x 10 mg, single-dose capsule
16284302|NCT00759902|Drug|KADIAN (morphine sulfate extended-release) capsules|1 x 20 mg, single-dose capsule
16284305|NCT00759850|Device|Drug Eluting Stent (DES)|Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.
16284306|NCT00759837|Drug|Bosutinib|
16284307|NCT00759824|Drug|Adriamycin, cyclophosphamide, vindesine, valproic acid|Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally
16284308|NCT00759811|Drug|Methotrexate|"Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
~All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks."
16284309|NCT00759811|Drug|Placebo|"Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
~All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks."
16284310|NCT00759798|Drug|Fludarabine|25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
16284311|NCT00759798|Drug|Cyclophosphamide|250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
16284312|NCT00759798|Drug|Rituximab|"375 mg/m2 given intravenously on Day 1 of Course 1
~All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)"
16284313|NCT00759785|Drug|dalotuzumab (MK0646)|Single intravenous infusion
16284314|NCT00759772|Drug|Placebo|sc daily for 6 months
16284315|NCT00759772|Drug|Teriparatide|20 mcg sc daily for 6 months
16284316|NCT00759759|Drug|morphine sulfate sustained-release capsules|1 x 200 mg, single-dose capsule
16284317|NCT00759759|Drug|KADIAN (morphine sulfate sustained-release) capsules|2 x 100 mg, single-dose capsule
16284318|NCT00759746|Behavioral|SFM+ Low Dose|The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet less often than families that receive the Social Facilitation Maintenance (SFM) - High Dose intervention, giving them more opportunities to practice new skills between clinic visits.
16284319|NCT00759746|Behavioral|Weight Maintenance Education|The Weight Maintenance Education intervention will help participants in parent and child groups to learn more about healthy eating and physical activity in a group setting. Participants will also learn about exercise and exercise safety, hydration during exercise, and stress management. Parent and child groups will combine for particular on-site and off-site activities, such as cooking demonstrations, grocery store tours, gym tours, and dance lessons.
16284320|NCT00759746|Behavioral|SFM+ High Dose|The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet more often than families that receive the Social Facilitation Maintenance (SFM) - Low Dose intervention, allowing for more in-depth discussion and practice of key skills and concepts related to creating a social environment that supports a healthy lifestyle. These participants will receive more feedback and reinforcement from fellow group members, family interventionists, and group leaders for practicing their new behaviors.
16284321|NCT00759733|Procedure|echocardiography|A non-invasive assessment of cardiac function using sound waves to create a picture of the pregnant woman's heart. There is no radiation involved.
16284322|NCT00759733|Procedure|blood draw for serum B-type natriuretic peptide|A simple, minimally invasive standard blood draw for assessment of serum B-type natriuretic peptide, to be measured in a standard hospital laboratory and recorded for research purposes only
16284323|NCT00759720|Drug|TAK-559 and glyburide|TAK-559 16 mg, tablets, orally, once daily and glyburide stable dose orally, once daily for up to 26 weeks.
16284324|NCT00759720|Drug|TAK-559 and glyburide|TAK-559 32 mg, tablets, orally, once daily and glyburide stable dose, orally, once daily for up to 26 weeks.
16284325|NCT00759720|Drug|Glyburide|TAK-559 placebo-matching tablets, orally, once daily and glyburide stable dose, orally, once daily for up to 26 weeks.
16284326|NCT00759707|Drug|L-N^G monomethyl arginine (L-NMMA)|L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein [arterial] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA.
16284327|NCT00759681|Device|ArterX Surgical Sealant|Apply at the suture site.
16284328|NCT00759681|Device|Gelfoam and Thrombin|Apply at the suture site.
16284329|NCT00759668|Device|Acrysof Natural ReSTOR SN60D3|Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
16284330|NCT00759668|Device|Acrysof Natural Monofocal SN60AT|Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
16284331|NCT00759655|Biological|Moroctocog alfa|Patients will receive Moroctocog alfa according to their investigator's prescription.
16284332|NCT00759642|Drug|lapatinib|lapatinib 1500 mg PO daily
16284372|NCT00759291|Drug|acipimox|250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
16284333|NCT00759629|Other|Interventional treatment group|Patients assigned to PCI will receive the loading dose of clopidogrel (300 mg), 500 mg aspirin plus a bolus of 70 U/kg heparin i.v. and be transferred immediately for interventional treatment. They will receive abciximab as a bolus of 0.25 mg/Kg of body weight followed by a continuous infusion of 0.125 µg/Kg/minute (up to a maximal dose of 10 µg/minute) for 12 hours. All patients will undergo coronary angiography and left ventriculography in the conventional way. During the procedure patients will receive the weight-adjusted heparin doses (70 U/ kg). Post-procedural antithrombotic therapy will consist of clopidogrel in a daily dose of 75 mg for at least 4 weeks (6 months recommended) and aspirin, 100 mg to 350 mg daily, indefinitely.
16284334|NCT00759629|Other|Conservative treatment group|Patients assigned to this group will receive the usual therapy in the intensive care unit of the admitting hospital according to local standards. Per protocol, all patients in this arm will receive a loading dose of clopidogrel (300 mg) followed by 75 mg/day for at least 4 weeks (6 months recommended) after randomization and aspirin, indefinitely. Recommended additional regimen will include heparin, ß-blockers, ACE inhibitors and statins
16284335|NCT00759616|Device|Oxford Partial Knee|Oxford Partial Knee
16284336|NCT00759603|Drug|Lenalidomide|Started on Day 9 of Cycle 1 at the dose of 10 mg/day and continued daily. Treatment duration will be twelve cycles.
16284337|NCT00759603|Drug|Rituximab|Dose of 375 mg/m^2 given intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2.
16284338|NCT00759590|Procedure|CT scan and Pressure volume curve|CT scan
16284339|NCT00759577|Drug|Solifenacin|5mg and 10 mg, oral once daily
16284340|NCT00759564|Drug|CP-70,429 and PF-03709270|Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).
16284341|NCT00759551|Drug|Azilsartan|Azilsartan 2.5 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
16284342|NCT00759551|Drug|Azilsartan|Azilsartan 5.0 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
16284343|NCT00759551|Drug|Azilsartan|Azilsartan 10 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
16284344|NCT00759551|Drug|Azilsartan|Azilsartan 20 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
16284345|NCT00759551|Drug|Azilsartan|Azilsartan 40 mg, tablets, orally, once daily and olmesartan placebo-matching capsules and tablets, orally, once daily for up to 8 weeks.
16284346|NCT00759551|Drug|Placebo|Azilsartan placebo-matching tablets, orally, once daily and olmesartan placebo-matching capsules, orally, once daily for up to 8 weeks.
16284347|NCT00759551|Drug|Olmesartan|Azilsartan placebo-matching tablets, orally, once daily and olmesartan 20 mg, capsules, orally, once daily for up to 8 weeks.
16284348|NCT00759525|Drug|Glycyrrhetic Acid|130 mg daily for fourteen days
16284349|NCT00759525|Drug|Placebo|Placebo daily for fourteen days
16284350|NCT00759512|Other|Therapeutic Touch|
16284351|NCT00759473|Drug|D-Cycloserine (DCS)|50 mg d-cycloserine or placebo taken orally
16284352|NCT00759473|Drug|Placebo|
16284353|NCT00759460|Drug|Sertindole|12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
16284354|NCT00759460|Drug|Olanzapine|10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
16284355|NCT00759447|Device|Genesis and Gemini|3 dimensional breast mammography system
16284356|NCT00759447|Device|Investigational 3D Mammography system|3 dimensional breast mammography system
16284357|NCT00759434|Procedure|Surgery - Saphenofemoral ligation, saphenous strip and avulsions|Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.
16284358|NCT00759434|Procedure|EVLT|Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.
16284359|NCT00759421|Drug|Sertindole|12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
16284360|NCT00759421|Drug|Olanzapine|10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
16284361|NCT00759408|Drug|BQ-123|6-120 µg/min
16284362|NCT00759395|Drug|AZD2327|Tablet, Oral, Daily
16284363|NCT00759395|Drug|Placebo|Tablet, Oral, Daily
16284364|NCT00759369|Other|Water prescription|Water prescription in 12 to 16 equally divided doses
16284365|NCT00759356|Drug|morphine sulfate sustained-release capsules|1 x 200 mg, single-dose capsule
16284366|NCT00759356|Drug|KADIAN|2 x 100 mg, single-dose capsule
16284367|NCT00759330|Drug|Placebo Tape (Arm 1)|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
16284368|NCT00759330|Drug|Flurbiprofen Tape (Arm 2)|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
16284369|NCT00759330|Drug|Placebo Tape (Arm 3)|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
16284370|NCT00759330|Drug|Flurbiprofen Tape (Arm 4)|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
16284371|NCT00759317|Drug|venlafaxine (Effexor)|Matching capsules containing either venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule.
16284475|NCT00758511|Procedure|facilitated tucking|facilitated tucking before, during and after heel stick
16284373|NCT00759291|Drug|Placebo|1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
16284374|NCT00759278|Procedure|ultrasound evaluation in pregnancy|Subjects enrolled will have a series of ultrasound evaluations to assess parameters in the study. Ultrasound is a non-invasive technique for creating images that does not use radiation and is routine in obstetrical practice
16284375|NCT00759265|Other|resistance training|"During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks).
~During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home."
16284376|NCT00759239|Drug|Travoprost 0.004% / Timolol maleate 0.5%|Solution, morning dosing
16284377|NCT00759239|Drug|Travoprost 0.004% / Timolol maleate 0.5%|Solution, evening dosing
16284378|NCT00759226|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 (30 min)
16284379|NCT00759226|Drug|Cisplatin|Cisplatin 30 mg/m2 (90 min)
16284380|NCT00759226|Drug|5-FU|5-FU 750 mg/m2 (24h CI)
16284381|NCT00759226|Drug|Folinic Acid|Folinic Acid 200 mg/m2 (30 min)
16284382|NCT00759200|Drug|alb-interferon alfa 2b|900 mcg every 4 weeks
16284383|NCT00759200|Drug|alb-interferon alfa 2b|1200 mcg every 4 weeks
16284384|NCT00759200|Drug|alb-interferon alfa 2b|1500 mcg every 4 weeks
16284385|NCT00759200|Drug|alb-interferon alfa 2b|1800 mcg every 4 weeks
16284386|NCT00759200|Drug|peg-interferon|Peg-interferon alfa 2a: 180 mcg 1x per wk.
16284387|NCT00759187|Drug|Fluoride|Brush twice daily
16284388|NCT00759187|Drug|Triclosan/Fluoride|Half mouth toothbrushing twice daily for 4 days
16284389|NCT00759187|Drug|Chlorhexidine Gluconate|Mouth rinsing twice a day for 4 days
16284390|NCT00759174|Drug|No intervention|No intervention occurs in this observational study.
16284391|NCT00759161|Drug|AN2728|AN2728 Ointment, 5%, twice daily for 4 weeks
16284392|NCT00759161|Drug|AN2728 Ointment Vehicle|AN2728 Ointment Vehicle, twice daily for 4 weeks.
16284393|NCT00759148|Drug|Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%|Eye drops
16284394|NCT00759148|Other|Moxifloxacin AF Vehicle|Inactive ingredients used as a placebo for masking purposes
16284395|NCT00759135|Drug|2.5 mg NX-1207|Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
16284396|NCT00759135|Drug|0.125 mg NX-1207|Low dose; single intraprostatic injection of 0.125 mg NX-1207
16284397|NCT00759135|Drug|finasteride|Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
16284398|NCT00759122|Drug|venlafaxine (Effexor)|Matching capsules containing venlafaxine 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.
16284399|NCT00759122|Drug|placebo|Matching capsules containing placebo 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.
16284400|NCT00759109|Biological|Peginterferon alfa-2b|Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years.
16284401|NCT00759109|Other|Observation (no treatment)|No treatment was given to participants enrolled in the control arm (Arm B).
16284402|NCT00759096|Device|RESTOR IOL Model SA60D3|Implanted into the study eye following cataract extraction surgery
16284403|NCT00759083|Drug|bivalirudin|Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure
16284404|NCT00759070|Drug|Tenofovir + emtricitabine + efavirenz|"Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)
~+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily"
16284405|NCT00759070|Drug|Tenofovir + emtricitabine + lopinavir/ritonavir|Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
16284406|NCT00759057|Device|Posterior Pedicle Screw System|Implantation of Posterior Pedicle Screw System
16284407|NCT00759031|Drug|Sodium Monofluorophosphate|Brush teeth and evaluate plaque score after one use of the study toothpaste
16284408|NCT00759031|Drug|Triclosan/Fluoride/Copolymer|Brush teeth and evaluate plaque score after one use of the study toothpaste
16284409|NCT00759018|Biological|remestemcel-L|Patients will be treated with Prochymal® twice per week at a dose of 2 x 10^6 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
16284410|NCT00759005|Drug|propranolol and cortisol|
16284411|NCT00758966|Drug|Fluoxetine 60 mg|Two week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy.
16284412|NCT00758966|Drug|Naltrexone 32 mg and fluoxetine 60 mg|Two week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg.
16284413|NCT00758966|Drug|Naltrexone SR 32 mg|Two week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy.
16284414|NCT00758953|Drug|Danazol Once Weekly|semi-solid
16284415|NCT00758953|Drug|Danazol Twice Weekly|semi-solid
16284416|NCT00758953|Drug|Placebo Once Weekly|semi-solid
16284417|NCT00758953|Drug|Placebo Twice Weekly|semi-solid
16284418|NCT00758940|Device|Acrysof ReSTOR multifocal IOL|Implanted into the study eye following cataract extraction surgery
16284419|NCT00758927|Drug|Omega-3 acid 4 grams per day|OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
16284420|NCT00758927|Drug|Placebo control|Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
16284421|NCT00758914|Dietary Supplement|Vitamin E|200 IU alpha-tocopherol or placebo for 1 year.
16284422|NCT00758901|Device|Knee Replacement (with ROCC Knee prosthesis)|Knee Replacement (with ROCC Knee prosthesis)
16284423|NCT00758888|Procedure|Orthopedic Blocking|Place the blocks under the pelvis for 2 minutes
16284424|NCT00758888|Procedure|Trochanter Belt|Participant is fitted with trochanter belt on the adjusting table and wear it while Investigator checks their flexion and extension strength.
16284425|NCT00758888|Other|Blocking Sham|Participant lies on adjusting table, blocks are placed in a similar configuration but distant to actual points of leverage.
16284426|NCT00758862|Drug|2% TD1414 Cream|Application 3 times daily for 7 days
16284427|NCT00758849|Drug|Placebo|One placebo tablet administered tid for 12 days in each of the three crossover treatment blocks, each block separated by 2-days placebo washout
16284428|NCT00758849|Drug|Fipamezole|One 30-mg tablet of Fipamezole tid from day 1 to 3; one 60-mg tablet of Fipamezole tid from Day 4 to 6; and one 90-mg tablet of Fipamezole tid from Day 7 to 12 in each of the three crossover treatment blocks, each block separated by 2-days placebo washout
16284429|NCT00758836|Drug|placebo|
16284430|NCT00758836|Drug|ibuprofen|
16284431|NCT00758836|Drug|acetominophen|
16284432|NCT00758836|Drug|telcagepant|
16284433|NCT00758823|Device|Paranix|pediculicide product
16284434|NCT00758797|Other|Photoimmunotherapy|DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
16284435|NCT00758784|Drug|bromfenac ophthalmic solution 0.06%|bromfenac ophthalmic solution 0.06% bilaterally twice a day
16284436|NCT00758758|Device|Anterior Cervical Discectomy and Fusion|Implantation of Hedrocel
16284437|NCT00758758|Device|Anterior Cervical Discectomy and Fusion|Implantation of Allograft
16284438|NCT00758758|Device|Anterior Cervical Discectomy and Fusion|Implantation of Autograft
16284439|NCT00758745|Device|Model SN60WF|Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
16284440|NCT00758745|Device|Model MA60AC|Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
16284441|NCT00758732|Drug|Docetaxel|Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
16284442|NCT00758732|Drug|Carboplatin|Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
16284443|NCT00758732|Drug|Docetaxel|Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.
16284444|NCT00758732|Drug|Liposomal doxorubicin|Liposomal doxorubicin at the dose of 20 mg/m2 over a 90 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.
16284445|NCT00758706|Drug|AZD1236|oral tablet, 75 mg, twice daily during 6 weeks
16284446|NCT00758706|Drug|Placebo|Dosing to match AZD1236
16284447|NCT00758693|Drug|Bendamustine|Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
16284448|NCT00758693|Drug|Rituximab|Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
16284449|NCT00758680|Drug|MK-1006|MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.
16284450|NCT00758680|Drug|Comparator: Placebo comparator|Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.
16284451|NCT00758667|Drug|Mesna|B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
16284452|NCT00758641|Device|L-PRP Injection|L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit
16284453|NCT00758641|Drug|Corticosteroid Injection|kenacort 40 mg/ml triamcinolon acetonide
16284454|NCT00758628|Drug|Bromefenac|Bromfenac BID 3 months
16284455|NCT00758628|Drug|Blink|Blink BID for 3 months
16284456|NCT00758615|Behavioral|Walking School Bus|Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.
16284457|NCT00758602|Drug|mycophenolate mofetil|0.75-1 g PO BID from Day 0 through Month 12
16284458|NCT00758602|Drug|tacrolimus, standard dose|Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.
16284459|NCT00758602|Drug|tacrolimus, low dose|Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.
16284460|NCT00758602|Drug|corticosteroids|According to center's practice
16284461|NCT00758589|Drug|AZD1981|Oral tablet, 50 mg twice daily
16284462|NCT00758589|Drug|AZD1981|Oral tablet, 400 mg twice daily
16284463|NCT00758589|Drug|AZD1981|Oral tablet, 1000 mg twice daily
16284464|NCT00758589|Drug|Placebo|
16284465|NCT00758576|Device|ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1|Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.
16284466|NCT00758563|Drug|Fluoride|Brush twice daily
16284467|NCT00758563|Drug|Triclosan/Fluoride|Brush twice daily
16284468|NCT00758550|Device|AcrySof® Toric IOL|AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
16284469|NCT00758550|Device|AcrySof Natural|AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
16284470|NCT00758524|Drug|LCI699|LCI699 oral capsules
16284471|NCT00758524|Drug|Eplerenone|Eplerenone oral capsules
16284472|NCT00758524|Drug|LCI699-matching Placebo|LCI699-matching placebo oral capsules
16284473|NCT00758524|Drug|Eplerenone-matching Placebo|Eplerenone-matching placebo oral capsules
16284474|NCT00758511|Procedure|25% Sucrose|orally administrated 25%Sucrose before, during and after heel stick
16284476|NCT00758511|Procedure|Sucrose and facilitated tucking|orally administrated 25%sucrose and facilitated tucking before, during and after heel stick
16284477|NCT00758498|Drug|armodafinil|50 mg/day orally, once daily in the morning for 3 days
16284478|NCT00758498|Drug|armodafinil|150 mg/day orally, once daily in the morning for 3 days
16284479|NCT00758498|Drug|placebo|placebo tablets, once daily in the morning for 3 days
16284480|NCT00758485|Drug|Sugammadex|At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.
16284481|NCT00758485|Drug|0.9% sodium chloride (NaCl)|At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.
16284482|NCT00758472|Device|ReCap Total Hip Resurfacing|ReCap Total Hip Resurfacing
16284483|NCT00758459|Drug|AZD1236|oral tablet, 75 mg, twice daily during 6 weeks
16284484|NCT00758459|Drug|Placebo|Dosing to match AZD1236
16284485|NCT00758446|Drug|BLX-028914|50 mg capsules, p.o, daily, 14 days
16284486|NCT00758446|Drug|BLX-028914|15 mg capsules, p.o, daily, 14 days
16284487|NCT00758446|Drug|placebo|capsules, p.o, daily, 14 days
16284488|NCT00758433|Drug|Zucapsaicin|Civamide patch 0.0075% q.d. 24 hours for 7 days
16284489|NCT00758433|Drug|Zucapsaicin|Civamide patch 0.0150% q.d. 24 hours for 7 days
16284490|NCT00758433|Drug|Placebo patch|Placebo patch q.d. 24 hours for 7 days
16284491|NCT00758420|Drug|Varisolve (Polidocanol Endovenous Microfoam)|1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
16284492|NCT00758420|Drug|Agitated Saline|10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
16284493|NCT00758407|Drug|Methylphenidate hydrochloride|sustained release, dosage according to an individual titration schedule
16284494|NCT00758407|Drug|Placebo|dosage according to an individual titration schedule
16284495|NCT00758394|Drug|Fluoride|Brush two times a day for 4 days.
16284496|NCT00758394|Drug|Triclosan/Fluoride|Brush two times daily for 4 days
16284497|NCT00758394|Drug|Triclosan/Fluoride|Brush twice daily for 4 days
16284498|NCT00758394|Drug|Triclosan/Fluoride|Brush twice daily for 4 days
16284499|NCT00758381|Drug|Sorafenib 400 mg po bid, continuously|"NEXAVAR*112CPR RIV 200MG
~Titolare AIC:
~BAYER SpA
~Numero di AIC dell'IMP:
~037154010"
16284500|NCT00758381|Drug|Gemcitabina, Cisplatino|Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days
16284501|NCT00758368|Drug|Apomorphine|Participants in both arms will receive the study drug apomorphine for 6 months. One group will receive it continuously using a portable pump during waking hours, and the other group will receive it intermittently by bolus injections. The continuous delivery group will receive up to 100 mg apomorphine per 24 hours, delivered subcutaneously by ambulatory pump. The intermittent delivery group will receive up to 5 subcutaneous injections totaling up to 20 mg daily.
16284502|NCT00758342|Drug|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
16284503|NCT00758342|Drug|Travoprost 0.004% + Tears Natural|Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
16284504|NCT00758329|Device|ReCap Total Hip Resurfacing|ReCap Total Hip Resurfacing
16284505|NCT00758316|Other|Thoracoscopy and Pleurx|Talc poudrage and tunneled pleural catheter
16284506|NCT00758316|Procedure|Thoracoscopy|Talc poudrage
16284507|NCT00758303|Drug|Low Dose TRIA-662|One Capsule 3 times a day
16284508|NCT00758303|Drug|High Dose TRIA-662|3 Capsules 3 times daily
16284509|NCT00758303|Drug|Placebo for TRIA-662|Matching Placebo for TRIA-662 taken 3 times a day
16284510|NCT00758290|Drug|Triclosan/Fluoride|Brush twice daily for 3 weeks
16284511|NCT00758290|Drug|Fluoride/triclosan|Brush daily for 3 weeks
16284512|NCT00758277|Drug|levetiracetam (Keppra)|levetiracetam daily application 1500-2000 mg
16284513|NCT00758277|Drug|Placebo|Sugar Pill
16284514|NCT00758264|Biological|Meningococcal vaccine GSK134612|Single dose intramuscular injection.
16284515|NCT00758264|Biological|Pneumococcal vaccine GSK1024850A|Single dose intramuscular injection.
16284516|NCT00758238|Other|myBP facilitated e-health self-management|MyOSCAR, a web-based patient-controlled personal health record, provides a mechanism for patients to enter/track health information and can encourage longitudinal patient engagement, better interaction between patients and health care providers, and patient self management. The intervention will provide access via MyOSCAR to a cardiovascular risk profile and BP tracker with sharing to providers enabled. Patients can receive general information about hypertension management; tailored messages related to their modifiable risk factors; and secure messaging with multiple providers. Providers can draw on a 'menu' of links/resources to share with patients. A lifestyle changes planner/checklist and an enhanced medication diary are additional components.
16284517|NCT00758225|Drug|Idebenone|Patients ≤ 45 kg: 450 mg/day (1 tablet 3 times a day) Patients > 45 kg: 900 mg/day (2 tablets 3 times a day)
16284518|NCT00758212|Biological|Mesotherapy|The regular seasonal trivalent Influenza vaccine( Vaxigrip) will be diluted 1:10 in saline.The diluted vaccine will be given intra-dermally using Mesotherapy,namely multiple injections given at one time in the torso, back and axillae.
16284519|NCT00758199|Drug|Bromfenac|Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
16284520|NCT00758199|Drug|Moxifloxacin hydrochloride|Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
16284521|NCT00758199|Drug|Prednisolone Acetate|Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
16284522|NCT00758186|Procedure|Emergency endoscopic colonic stenting|Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. Patients who had successful stenting were discharged and re-admitted for elective surgery. Patients in whom stenting was unsuccessful underwent emergency surgery. The choice of surgery performed was up to the individual consultant colorectal surgeon.
16284585|NCT00757744|Behavioral|Drug counseling|individual drug counseling
16284586|NCT00757731|Drug|milnacipran|hard capsule
16284523|NCT00758186|Procedure|Emergency surgery|Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. The choice of surgery performed was up to the individual consultant colorectal surgeon. Surgery included primary resection with or without defunctioning stoma and palliative diverting stoma only.
16284524|NCT00758173|Genetic|polymorphism analysis|
16284525|NCT00758173|Other|laboratory biomarker analysis|
16284526|NCT00758173|Other|questionnaire administration|
16284527|NCT00758160|Drug|OROS Methylphenidate|Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
16284528|NCT00758147|Device|Exercise with force feedback joystick|System consists of a commercially available force feedback joystick, and specially written software. Patients will work with the system 5 times a week for 4 weeks, a half hour each time, 2 weeks with visual and haptic feedback and 2 weeks without the feedback.
16284529|NCT00758134|Drug|Trastuzumab (Herceptin)|Trastuzumab 6 mg/Kg every 3 weeks i.v. (loading dose 8 mg/Kg i.v.)
16284530|NCT00758121|Device|Cardiac Resynchronization Therapy Defibrillator|CRT-D observational study
16284531|NCT00758082|Device|paper support|Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
16284532|NCT00758082|Device|PDA-phone + telemonitoring|Patients will received PDA-phone + a telephone follow up + standard visit at 3 months
16284533|NCT00758069|Drug|sitagliptin phosphate|100 mg once daily (QD), taken orally for 4 weeks
16284534|NCT00758069|Drug|Comparator: Placebo|Placebo tablet, QD, taken orally for 4 weeks
16284535|NCT00758069|Drug|Comparator: Sitagliptin|50 mg twice daily (BID), taken orally for 4 weeks
16284536|NCT00758056|Genetic|polymorphism analysis|
16284537|NCT00758056|Other|laboratory biomarker analysis|
16284538|NCT00758056|Other|questionnaire administration|
16284539|NCT00758043|Drug|telaprevir|750 mg every 8 hours (q8h) for 12 weeks
16284540|NCT00758043|Drug|ribavirin|1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
16284541|NCT00758043|Biological|peginterferon alfa-2a|180 mcg/week for either 24 or 48 weeks
16284542|NCT00758030|Drug|Paliperidone ER OROS|
16284543|NCT00758017|Other|Acupuncture 1|Application of individualised acupuncture
16284544|NCT00758017|Other|Acupuncture 2|Application of standardised acupuncture
16284545|NCT00758004|Drug|Atorvastatin|A single dose of 80 mg atrovastatin tablet
16284546|NCT00758004|Drug|Atorvastatin pediatric appropriate formulation|A single dose of pediatric appropriate atorvastatin 80 mg formulation
16284547|NCT00757991|Genetic|polymorphism analysis|
16284548|NCT00757991|Other|laboratory biomarker analysis|
16284549|NCT00757991|Other|questionnaire administration|
16284550|NCT00757978|Drug|memantine|memantine 10mg twice a day
16284551|NCT00757978|Drug|placebo|1 capsule of placebo twice a day
16284552|NCT00757965|Genetic|polymorphism analysis|
16284553|NCT00757965|Other|laboratory biomarker analysis|
16284554|NCT00757965|Other|questionnaire administration|
16284555|NCT00757952|Other|Fourier transform ion cyclotron resonance mass spectrometry|
16284556|NCT00757952|Other|chromatography|
16284557|NCT00757952|Other|diagnostic laboratory biomarker analysis|
16284558|NCT00757952|Other|questionnaire administration|
16284559|NCT00757939|Other|MRI|During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
16284560|NCT00757939|Other|FDG-PET|2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable
16284561|NCT00757926|Biological|Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]|Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.
16284562|NCT00757926|Other|Placebo|Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.
16284563|NCT00757913|Dietary Supplement|n-3 enriched nutrition|
16284564|NCT00757900|Biological|MUTAGRIP|Purified polyvalent vaccine for active immunisation against influenza.The vaccine is an inactivated split virus mixture of different group A and B viral strains. One 0.5 ml dose, intramuscular route.
16284565|NCT00757887|Biological|Exposure to 5 P. falciparum infected mosquitoes|Five Anopheles Stephensi mosquitoes are infected with NF54 P.falciparum. volunteers are exposed to bites for 10 minutes.
16284566|NCT00757874|Drug|Tacrolimus cream|0.5 g per day at bed time for 3 months or less.
16284567|NCT00757874|Drug|Clobetasol cream|0.5 gram each day at bed time during 3 months or less.
16284568|NCT00757848|Drug|AZD9668|60 mg, oral tablet, twice daily for 28 days
16284569|NCT00757848|Drug|AZD9668 Placebo equivalent|Match placebo to 60 mg, oral tablet, twice daily for 28 days
16284570|NCT00757835|Drug|treatment with latanoprost/timolol fixed combination|dosing in the evening with the two fixed combinations
16284571|NCT00757835|Drug|latanoprost/timolol fixed combination drops|once in the evening
16284572|NCT00757822|Drug|Dronabinol|Dronabinol (5mg) will be administered orally (p.o.) 20-60 min pre-operatively.
16284573|NCT00757822|Drug|Ondansetron|Ondansetron (4mg) will be administered intravenously (iv) intraoperatively in those patients not receiving Dronabinol.
16284574|NCT00757809|Drug|neratinib|HKI-272
16284575|NCT00757783|Drug|ritonavir|100 mg capsule or tablet once daily for 48 weeks
16284576|NCT00757783|Drug|ritonavir|100 mg capsule or tablet once daily for 48 weeks
16284577|NCT00757783|Drug|darunavir|800 mg tablet once daily for 48 weeks
16284578|NCT00757783|Drug|emtricitabine [FTC]/tenofovir [TDF]|200/300 mg tablet once daily for 48 weeks
16284579|NCT00757783|Drug|emtricitabine [FTC]/tenofovir [TDF]|200/300 mg once daily for 48 weeks
16284580|NCT00757783|Drug|atazanavir|300 mg capsule once daily for 48 weeks
16284581|NCT00757770|Biological|Rotarix|Two oral doses.
16284582|NCT00757770|Biological|Placebo|Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.
16284583|NCT00757757|Drug|MCS110|Anti-M-CSF antibody
16284584|NCT00757744|Behavioral|Behavioral Drug and HIV Risk Reduction Counseling (BDRC)|once weekly individual counseling
16284588|NCT00757718|Device|CPAP|One half of the subjects will be randomly assigned to wear continuous a positive airway pressure device on the second night of the study. Portable polysomnography will be repeated for this night and morning bloodwork for inflammatory markers will be repeated.
16284589|NCT00757718|Device|Oral Appliance|Half of the subjects will be assigned to wear an oral appliance and nasal strip on the second night of the study. Repeat portable polysomnography will be performed and morning bloodwork will again be drawn for inflammatory markers.
16284590|NCT00757705|Drug|Paliperidone ER|Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.
16284591|NCT00757692|Drug|Vandetanib|Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously
16284592|NCT00757692|Drug|Bicalutamide|Bicalutamide at 50 mg will be administered orally, daily and continuously.
16284593|NCT00757679|Drug|Milnacipran|capsules
16284594|NCT00757679|Drug|Placebo|capsules
16284595|NCT00757666|Device|Rate adaptive pacemaker|Accelerometer sensor
16284596|NCT00757666|Device|Rate adaptive pacemaker|Minute ventilation sensor
16284597|NCT00757653|Device|Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA|Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
16284598|NCT00757653|Device|Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA|Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
16284599|NCT00757653|Device|Hip stem with Interloc Titanium surface + Bonemaster H.A|Hip stem with Interloc Titanium surface + Bonemaster H.A
16284600|NCT00757640|Procedure|cholecystectomy|prophylactic cholecystectomy during standard gastric surgery for cancer
16284601|NCT00757627|Drug|etoricoxib|etoricoxib 60 mg QD for 4 weeks.
16284602|NCT00757614|Genetic|DNA analysis|
16284603|NCT00757614|Genetic|polymorphism analysis|
16284604|NCT00757614|Other|laboratory biomarker analysis|
16284605|NCT00757614|Other|questionnaire administration|
16284606|NCT00757601|Drug|MK1006|"MK1006 capsules: 1 mg, 10 mg, and 20 mg.
~Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
~Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
~Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg.
~There will a 7-day interval between each dose"
16284607|NCT00757601|Drug|Placebo|"Placebo capsule to match MK1006 1, 10, and 20 mg.
~Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
~Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
~Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg.
~There will a 7-day interval between each dose"
16284608|NCT00757588|Drug|Saxagliptin, 5 mg + insulin|Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)
16284609|NCT00757588|Drug|Placebo + insulin|Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin
16284610|NCT00757562|Drug|desloratadine|desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days.
16284611|NCT00757562|Drug|Placebo|placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days.
16284612|NCT00757549|Biological|cetuximab|
16284613|NCT00757549|Drug|cisplatin|
16284614|NCT00757549|Genetic|TdT-mediated dUTP nick end labeling assay|
16284615|NCT00757549|Other|3'-deoxy-3'-[18F]fluorothymidine|
16284616|NCT00757549|Other|immunohistochemistry staining method|
16284617|NCT00757549|Other|laboratory biomarker analysis|
16284618|NCT00757549|Radiation|fludeoxyglucose F 18|
16284619|NCT00757549|Radiation|radiation therapy|
16284620|NCT00757536|Procedure|Encircling Band|ppVE and encircling band
16284621|NCT00757536|Procedure|Endolaser Photocoagulation|ppVE and endolaser photocoagulation
16284622|NCT00757523|Drug|Epiduo Gel|Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
16284623|NCT00757523|Drug|Duac Gel|Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
16284624|NCT00757497|Behavioral|Electrical Polarization|
16284625|NCT00757471|Procedure|Brillant Blue|Membrane Peeling with Brillant Blue
16284626|NCT00757471|Procedure|Indocyanine Green|Membrane Peeling with indocyanine Green
16284627|NCT00757458|Drug|EDTA without re-filling|Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.
16284628|NCT00757458|Other|Propofol syringe re-filling with propofol containing EDTA|Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.
16284629|NCT00757458|Other|Target controlled infusion of propofol without EDTA|Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment
16284630|NCT00757458|Other|Re-filling of syringe with propofol without EDTA|Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.
16284631|NCT00757419|Drug|AZD3355|capsules, oral, single or twice daily dose
16284632|NCT00757419|Drug|Placebo|To match dosing of AZD3355
16284633|NCT00757393|Dietary Supplement|Vitamin D + Calcium + Exercise program|Subjects is this arm of the study will receive a) a supplementation with vitamin D3, 1000 IU daily b) a dietary calcium intake set at DRI for age and a supplement used as needed to meet the requirement and c) a weight bearing exercise program appropriate for the underlying medical condition
16284634|NCT00757393|Drug|Vitamin D + Calcium + Exercise program + Humatrope|Subjects in this arm will receive the same as those in arm 1 as well as Humatrope by subcutaneous infection 7 days a week at a dose of 0.05 mg.kg/day.
16284635|NCT00757380|Procedure|Trypan Blue|Membranepeeling with TB
16284636|NCT00757380|Procedure|Brillant Blue|Membranepeeling and membrana limitans interna peeling with BB
16284637|NCT00757367|Drug|TI Inhalation Powder|1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2.
16284638|NCT00757354|Procedure|Metal on Metal cementless hip|Metal on Metal hip arthroplasty
16284639|NCT00757341|Drug|SKI-606|
16284640|NCT00757315|Device|NdYag Laser(hair removal laser) plus topical corticosteroid|NdYag laser and topical corticosteroid are applied to one half of the scalp.
16284641|NCT00757315|Drug|Topical corticosteroid alone|topical corticosteroid alone is applied to one half of the scalp
16284642|NCT00757302|Device|SLN procedure (CarolIReS camera)|"Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²).
~Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²)."
16284643|NCT00757289|Biological|PRP Injection|PRP Injection
16284644|NCT00757289|Biological|Corticosteroid Injection|Corticosteroid Injection
16284645|NCT00757263|Genetic|polymorphism analysis|
16284646|NCT00757263|Other|laboratory biomarker analysis|
16284647|NCT00757263|Other|questionnaire administration|
16284648|NCT00757250|Drug|Angiotensin 1-7|Once daily subcutaneous injection of 50, 100, 200 or 300 mcg/kg/day
16284649|NCT00757237|Drug|Aztreonam for Inhalation Solution (AZLI)|Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.
16284650|NCT00757237|Drug|Tobramycin Inhalation Solution (TIS)|Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.
16284651|NCT00757224|Behavioral|Guidance|Smoking parents will receive education on the association between parental smoking and respiratory morbidity in the infant. They will also be offered ways to reduce smoke exposure of their infants.
16284652|NCT00757211|Genetic|polymorphism analysis|
16284653|NCT00757211|Other|laboratory biomarker analysis|
16284654|NCT00757211|Other|questionnaire administration|
16284655|NCT00757198|Drug|remifentanil|remifentanil infusion
16284656|NCT00757198|Drug|remifentanil|remifentanil infusion
16284657|NCT00757185|Drug|ganirelix acetate|GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
16284658|NCT00757185|Drug|methyl testosterone|testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
16284659|NCT00757172|Biological|panitumumab|
16284660|NCT00757172|Drug|cisplatin|
16284661|NCT00757172|Drug|docetaxel|
16284662|NCT00757172|Procedure|neoadjuvant therapy|
16284663|NCT00757172|Procedure|therapeutic conventional surgery|
16284664|NCT00757172|Radiation|radiation therapy|
16284665|NCT00757159|Device|Ostim|Ostim® is synthetically manufactured and comprises nanocrystalline hydroxyapatite. The small particle size facilitates resorption. Ostim is an aqueous watery paste and can be used to fill bone defects or to build up bony structures in the region of the jaws. Ostim is osteoconductive, facilitating bone growth. It will act as a scaffolding for the new bone. Ostim is absorbed during the healing process, in the beginning it is osseously interweaved and finally replaced by natural bone.
16284666|NCT00757159|Device|Emdogain|Emdogain® consists of sterile lyophilised Enamel Matrix Derivative with sterile aqueous solution of Propylene Glycol Alginate, 30 mg/ml.
16284667|NCT00757133|Procedure|Conventional laparotomy closure|Recommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department
16284668|NCT00757133|Procedure|Laparotomy closure with mesh augmentation|"Recommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a Stoppa repair for incisional hernias"
16284669|NCT00757107|Device|Taperloc Microplasty|primary total hip arthroplasty
16284670|NCT00757107|Device|Taperloc standard|primary total hip arthroplasty
16284671|NCT00757081|Drug|phosphatidylcholine and deoxycholate|50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
16284672|NCT00757068|Behavioral|CBT addressing postpartum mood and weight concerns|Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. In these treatment sessions, the counselor will address postpartum mood and weight concerns.
16284673|NCT00757068|Behavioral|Supportive Behavioral Therapy|Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. A non-specific, supportive condition will be delivered to women who want to remain smoke-free after they give birth.
16284674|NCT00757055|Drug|Ivabradine|Ivabradine titrated to heart rate starting at 5 mg bd and increasing to maximum of 7.5 mg bd or reducing to 2.5 mg if heart rate < 60 bpm.
16284675|NCT00757055|Drug|Placebo|No active treatment given
16284715|NCT00756678|Drug|Lubricant Eye Drops (Optive™)|1 drop in both eyes as needed for 7 days'
16284716|NCT00756678|Drug|Lubricating Eye Drops (blink® Tears)|1 drop in both eyes as needed for 7 days
16284717|NCT00756652|Device|Mentor Silicone Gel-Filled Breast Implants|
16284676|NCT00757042|Drug|AMG 157|Part A (healthy subjects): 6 subcutaneous (SC) cohorts and 2 intravenous (IV) cohorts receiving a single dose of either AMG 157 (dose escalating by cohort) or placebo. Part B (subjects with moderate to severe atopic dermatitis):two cohorts receiving a single dose (SC or IV; dose to be determined) of AMG 157 or placebo.
16284677|NCT00757029|Genetic|norepinephrine transporter polymorphism,|OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
16284678|NCT00757016|Drug|Triamcinolone|1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally.
16284679|NCT00757016|Drug|Saline solution|Saline solution
16284680|NCT00757003|Device|Endovascular Stent-graft repair of descending thoracic aorta|A TAG device will be used to repair the pathology in the thoracic aorta
16284681|NCT00756990|Drug|Depot Naltrexone|228mg of injectable naltrexone
16284682|NCT00756977|Drug|BLI850|multi-dose preparation for oral administration prior to colonoscopy
16284683|NCT00756977|Drug|polyethylene glycol 3350 based bowel preparation|multi-dose preparation for oral administration prior to colonoscopy
16284684|NCT00756964|Drug|Rasburicase|Rasburicase (Dose: 7.5mg in 50ml of normal saline administered over 30 minutes) or identical placebo will be administered as an (dosage form)intravenous infusion preoperatively.
16284685|NCT00756964|Drug|Placebo|Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infusion preoperatively.
16284686|NCT00756951|Drug|Placebo|Placebo
16284687|NCT00756951|Drug|SCV-07|0.02 mg/kg
16284688|NCT00756951|Drug|SCV-07|0.10 mg/kg
16284689|NCT00756938|Drug|losartan potassium|losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.
16284690|NCT00756925|Drug|Acthrel|1 ug/kg, i.v., 1 minute
16284691|NCT00756912|Drug|E5564|Three dose levels of Eritoran IV over 14 days for a total of 32, 96, and 224 mg over 14 days.
16284692|NCT00756886|Drug|Atorvastatin|40 mg QD 7 day continue after procedure for 14 days
16284693|NCT00756886|Drug|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
16284694|NCT00756873|Drug|Administration of placebo|Placebo qd orally day 0-14
16284695|NCT00756873|Drug|Administration of etoricoxib|Etoricoxib 90 mg qd orally day 0-14
16284696|NCT00756873|Drug|Administration of etoricoxib|Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14
16284697|NCT00756860|Drug|AMG 223|2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7
16284698|NCT00756860|Drug|Renagel® (sevelamer hydrochloride)|2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7
16284699|NCT00756847|Drug|XL147 (SAR245408),|Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing
16284700|NCT00756847|Drug|paclitaxel|Intravenous injection dosed once every three weeks
16284701|NCT00756847|Drug|carboplatin|Intravenous injection dosed once every three weeks
16284702|NCT00756834|Device|Screening|The MammoDetector™ Pro is a computer-aided software intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the device assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review
16284703|NCT00756795|Behavioral|Intervention group|"5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.
~Structured Interview will be conducted at baseline and post-intervention.
~Patients assigned to the Intervention group will be given pedometers to obtain distance walked. In addition, patient will be taught how to keep the Exercise diary to record walking and physical activities.
~All patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis."
16284704|NCT00756782|Drug|TAC-101|Patients will receive TAC-101 20 mg (2 x 10-mg formulated tablets) administered orally every day with approximately 8 oz. water within 1 hour following a morning meal for 14 days followed by a 7-day recovery period, repeated every 21 days.
16284705|NCT00756782|Drug|Placebo|Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment
16284706|NCT00756756|Drug|G-CSF|after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg
16284707|NCT00756756|Drug|placebo infusion of normal saline|2 week post MI and PCI normal saline was infused
16284708|NCT00756743|Drug|PF-04802540|Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data
16284709|NCT00756743|Drug|Placebo|Placebo capsules q12 hours for 10 days
16284710|NCT00756730|Drug|ATV/r|Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
16284711|NCT00756730|Drug|DRV/r|We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
16284712|NCT00756717|Drug|MK-0752|Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
16284713|NCT00756704|Behavioral|Smoking cessation guideline implementation|"a tutorial on brief cessation counseling for ED nurses and physicians
~use of an ED algorithm that includes recommended tobacco counseling items
~fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy
~group feedback to ED staff"
16284714|NCT00756691|Other|18F-FAZA|Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient
16284718|NCT00756652|Device|Saline Breast Implants|
16284719|NCT00756639|Radiation|Prophylactic Cranial Irradiation (PCI)|Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks.
16284720|NCT00756639|Other|Brain X-ray|On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.
16284721|NCT00756626|Behavioral|Bottle Weaning Intervention|WIC Nutritionist will deliver bottle weaning intervention education with participants in intervention group at 12 month baseline and at 15, 18, 21, and 24 month follow-up as needed
16284722|NCT00756600|Drug|Regional Anesthesia|Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
16284723|NCT00756600|Drug|General Anesthesia|Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
16284724|NCT00756587|Device|Cup Feeding|using a cup feeding technique for feeding the preterm infants during NICU stay
16284725|NCT00756587|Device|Bottle Feeding|receiving all feeding by bottle
16284726|NCT00756574|Device|Surgical mask|Surgical mask worn for patients with febrile respiratory illness
16284727|NCT00756574|Device|N95 mask|N95 mask worn for patients with febrile respiratory illness
16284728|NCT00756548|Drug|BLI850|multi-dose preparation for oral administration prior to colonoscopy
16284729|NCT00756548|Drug|polyethylene glycol 3350 based bowel preparation|multi-dose preparation for oral administration prior to colonoscopy
16284730|NCT00756535|Procedure|Exercise training|Group-based exercise training 5 days a week during hospitalization
16284731|NCT00756535|Procedure|usual treatment and rehabilitation|usual treatment and rehabilitation
16284732|NCT00756522|Other|There is no intervention. Study is observational.|There is no intervention. Study is observational.
16284733|NCT00756509|Drug|Nilotinib|800 mg/d orally
16284734|NCT00756496|Device|Mammography screening and diagnosis|Mammography screening and diagnosis
16284735|NCT00756470|Drug|Lapatinib|1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.
16284736|NCT00756470|Drug|Paclitaxel|80 mg/m^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.
16284737|NCT00756470|Drug|5-Fluorouracil (5-FU)|500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
16284738|NCT00756470|Drug|Epirubicin|75 mg/m^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.
16284739|NCT00756470|Drug|Cyclophosphamide|500 mg/m^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
16284740|NCT00756457|Device|Bracing|Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.
16284741|NCT00756457|Other|Strengthening exercises|"Participants performed strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises included bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a warm up."
16284742|NCT00756457|Other|Stretching exercises|Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.
16284743|NCT00756444|Drug|Panitumumab|This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
16284744|NCT00756444|Drug|Cisplatin|This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
16284745|NCT00756444|Drug|5FU|This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
16284746|NCT00756431|Device|Hip Fracture reduction Screw without HA Coating (Hiploc)|Hip Fracture reduction Screw without HA Coating (Hiploc)
16284747|NCT00756431|Device|Hip Fracture reduction Screw with HA Coating (Hiploc)|Hip Fracture reduction Screw with HA Coating (Hiploc)
16284748|NCT00756418|Drug|montelukast|montelukast 5 mg QD 4-weeks.
16284749|NCT00756418|Drug|Theophylline|Theophylline 100 to 200 mg BID 4-weeks.
16284750|NCT00756405|Behavioral|Antioxidant diet|Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.
16284751|NCT00756405|Dietary Supplement|Antioxidant supplement|Participants were asked to consume their usual diet and take a supplement containing carotenoids, mixed tocopherols, vitamin C and selenium, designed to approximately double their daily habitual intake.
16284752|NCT00756405|Dietary Supplement|Placebo|Participants were asked to consume their usual diet and take a placebo pill.
16284753|NCT00756392|Procedure|3T MR Spectroscopy|A Magnetic Resonance Spectroscopy (MRS)study of a patient's prostate will be conducted with the 3 Tesla Philips Intera Nuclear Magnetic Resonance (NMR) scanner before and after filling the rectum with barium. Scan duration from Preparation to Completion will be approximately 30 minutes. The spectra will be acquired without and with the presence of Barium solution to compare to see if the latter is advantageous.
16284754|NCT00756379|Other|Comprehensive therapy program for risk factor modification|Patients enrolled in the comprehensive therapy arm will have a baseline myocardial perfusion PET and the support of a team of professionals aiming to modify and minimize all the known CAD risk factors. During the 5 year follow-up they will be educated and guided toward a healthy lifestyle by a dietician, an exercise physiologist/cardiovascular physician specialist.
16284755|NCT00756366|Other|Positron Emission Tomography|PET imaging at baseline, 1 week and 6-8 weeks. CPAP begins after baseline PET scan.
16284756|NCT00756366|Other|Positron Emission Tomography|PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
16284847|NCT00755755|Drug|PGL4001 (ulipristal) and iron|Tablets
16284757|NCT00756366|Other|Positron Emission Tomography|PET scan at baseline and 6-8 weeks, no CPAP therapy
16284758|NCT00756340|Drug|Bevacizumab|"Bevacizumab IV every 2 weeks
~Dose Level 0- 8 mg/kg
~Dose Level 1 (starting dose)- 10 mg/kg
~Dose Level 2- 10 mg/kg"
16284759|NCT00756340|Drug|Everolimus|"Everolimus
~Dose Level 0- 4 mg/m2
~Dose level 1 (starting dose)- 4 mg/m2
~Dose Level 2- 5 mg/m2"
16284760|NCT00756314|Behavioral|Personalized contraceptive counseling|The intervention comprised a personalized and comprehensive (face-to-face) contraceptive counseling regarding to individual contraceptive history and needs. The counseling intervention was conducted by three trained gynecologists according to standard one day training.
16284761|NCT00756301|Other|Lidocaine local anesthesia- Alternative|Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
16284762|NCT00756288|Procedure|Topical retinoid and blue-light therapy with photosensitizing agent|Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4
16284763|NCT00756288|Procedure|Photodynamic Therapy (PDT)|Photo-therapy with sensitizing agent - apply to AKs at week 4
16284764|NCT00756275|Drug|Nicotine Replacement Treatment (NRT)|Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.
16284765|NCT00756275|Drug|varenicline|Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.
16284766|NCT00756275|Behavioral|Behavioral counseling for smoking cessation|The counseling consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.
16284767|NCT00756262|Biological|Lactobacillus GG or Culturelle|Drug to be administered orally (capsule form). Dose=2 capsules/day for 14 days. Dosage strength= 1x10^10 bacteria
16284768|NCT00756249|Drug|Lu AA24493 (CEPO)|0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
16284769|NCT00756249|Drug|Placebo|Vials with solution for IV infusion
16284770|NCT00756236|Drug|Metoprolol|60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
16284771|NCT00756236|Drug|Esmolol|60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
16284772|NCT00756236|Drug|P-Group|0.9%NaCl dispensed in 60ml & 5ml syringes
16284773|NCT00756223|Drug|Arm A|Dose escalation Arm A (4 weeks)
16284774|NCT00756223|Drug|Arm B|Dose escalation Arm B (3 weeks)
16284775|NCT00756210|Other|Whole body vibration|Frequence: 35 Hz Amplitude: 'high' (approx. 4 mm)
16284776|NCT00756197|Device|Cryo Spray Ablation Group 1|Cryo Spray Ablation
16284777|NCT00756197|Device|Cryo Spray Ablation Group 2|cryo spray ablation
16284778|NCT00756184|Device|TDA adherence monitor for travoprost therapy|monitoring adherence to travoprost therapy
16284779|NCT00756184|Device|TDA and travoprost monotherapy|Patients will be prescribed travoprost therapy and will be followed up in a standard clinical fashion with a attention placebo at both baseline and 6 months
16284780|NCT00756171|Drug|colesevelam|2 times 3 625 mg tablets daily, 3 weeks
16284781|NCT00756171|Drug|placebo|2 times 3 625mg tablets daily
16284782|NCT00756145|Procedure|At start of the session, at the inlet line|Injection of LMWH at the inlet line, at the start of the hemodiafiltration session
16284783|NCT00756145|Procedure|5 minutes after the start of the session, at the inlet line|Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session
16284784|NCT00756145|Procedure|At the start of the session, at the outlet line|Injection of LMWH at the outlet line, at the start of the hemodiafiltration session
16284785|NCT00756106|Drug|temozolomide|Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.
16284786|NCT00756106|Other|Imaging biomarker analysis|MRI
16284787|NCT00756106|Radiation|Photon Radiation Therapy|Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
16284788|NCT00756093|Other|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops one drop each eye one time
16284789|NCT00756093|Other|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops one drop each eye one time
16284790|NCT00756093|Other|Blink Tears|Blink Tears one drop each eye one time
16284791|NCT00756093|Other|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops one drop each eye one time
16284792|NCT00756080|Drug|citrulline|0.06 G/kg three times/day during 7 days
16284793|NCT00756080|Drug|placebo|placebo (equimolar mixture of 6 non essential amino acids: alanine, aspartate, glycine, histidine, proline, serine) 0,006 g/kg 3 times/day during 7 days
16284794|NCT00756067|Biological|Pneumococcal vaccine GSK2189241A|Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
16284795|NCT00756067|Biological|Pneumo 23™|One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.
16284796|NCT00756041|Drug|TAK-128|TAK-128 100 mg tablet, orally, once daily for up to 1 year.
16284797|NCT00756028|Drug|Patients receiving short protocol IVF/ICSI-treatment.|Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day
16284798|NCT00756028|Drug|Long protocol|Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
16284885|NCT00755495|Drug|Doxepin|Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
16284886|NCT00755495|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.
16284887|NCT00755482|Drug|Aquamin F|
16284799|NCT00756015|Other|Early Motion Protocol|Early range of motion group: Shoulder pendulum exercises will be allowed from the time of surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first postoperative visit, PROM of the shoulder will be permitted under therapist direction. Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be advanced as tolerated. Capsular stretching will be advanced until full range of motion is achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 3 months post surgery.
16284800|NCT00756015|Other|Immobilization|Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and capsular stretching advanced until full ROM achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.
16284801|NCT00756002|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
16284802|NCT00756002|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
16284803|NCT00755989|Drug|morphine topical gel|morphine gel 0.1%, applied every 12 hours to stage 2-3 wound, during their hospital stay
16284804|NCT00755989|Drug|placebo|topical gel without morphine
16284805|NCT00755976|Drug|epirubicin hydrochloride|
16284806|NCT00755976|Drug|sulindac|
16284807|NCT00755976|Other|immunologic technique|
16284808|NCT00755963|Drug|estradiol valerate|Progynova® 21; 2mg/d
16284809|NCT00755963|Drug|micronized progesterone|Utrogestan®; 200mg/d
16284810|NCT00755963|Drug|placebo|maltodextrin
16284811|NCT00755950|Dietary Supplement|Silymarin|280 mg three times daily for four weeks
16284812|NCT00755950|Dietary Supplement|Silymarin|420 mg three times daily for four weeks
16284813|NCT00755950|Other|Lactose monohydrate|Lactose monohydrate 326.95 mg three times daily for four weeks
16284814|NCT00755937|Other|Data collection post infusion|
16284815|NCT00755924|Dietary Supplement|Vinegar|Apple cider vinegar 2 TBlsp/day
16284816|NCT00755924|Other|Placebo|Water placebo colored with balsamic vinegar
16284817|NCT00755911|Biological|Tissue Repair Cells (TRC)|30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.
16284818|NCT00755911|Device|Control|Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
16284819|NCT00755898|Drug|Ingestion of a 200 mg dose of amantadine hydrochloride|Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.
16284820|NCT00755898|Drug|Ingestion of a 200 mg dose of amantadine hydrochloride|Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper
16284821|NCT00755885|Drug|abiraterone acetate|
16284822|NCT00755885|Other|laboratory biomarker analysis|
16284823|NCT00755885|Other|pharmacogenomic studies|
16284824|NCT00755872|Drug|Risedronate|Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
16284825|NCT00755872|Drug|Risedronate|Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.
16284826|NCT00755872|Drug|Risedronate|Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
16284827|NCT00755872|Drug|Risedronate|Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.
16284828|NCT00755859|Drug|steroids plus azathioprine|methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day plus azathioprine 1.5 mg/kg/day for six months
16284829|NCT00755859|Drug|steroids|methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day for six months
16284830|NCT00755846|Drug|Alogliptin|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
16284831|NCT00755846|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
16284832|NCT00755846|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
16284833|NCT00755846|Drug|Alogliptin|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
16284834|NCT00755846|Drug|Alogliptin|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
16284835|NCT00755846|Drug|Placebo|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
16284836|NCT00755833|Drug|biphasic insulin aspart 50|Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
16284837|NCT00755820|Behavioral|Exposure Therapy + D-Cycloserine|Exposure therapy with d-cycloserine medication
16284838|NCT00755820|Behavioral|Exposure Therapy + Placebo|Exposure therapy with placebo medication
16284839|NCT00755820|Behavioral|Supportive Psychotherapy|Supportive psychotherapy
16284840|NCT00755807|Drug|Duloxetine Hydrochloride (HCI)|Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
16284841|NCT00755807|Drug|Placebo|Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams [mg] QD for 12 weeks).
16284842|NCT00755794|Drug|montelukast sodium|Montelukast Tablet, 10 mg, 8 weeks, daily
16284843|NCT00755781|Drug|Cyclosporine Inhalation Solution (CIS)|Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration (up to 3 years)
16284844|NCT00755768|Behavioral|additional review by dietician|
16284845|NCT00755755|Drug|PGL4001 (ulipristal) and iron|tablets
16284846|NCT00755755|Drug|PGL4001 matching placebo and iron|tablets
16284848|NCT00755742|Other|Lifestyle intervention|"The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):
~i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits.
~ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater).
~iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided."
16284849|NCT00755729|Dietary Supplement|Preoperative Oral Carbohydrate|Patients in OCH group consumed 400 ml Nutricia preOp® (12.5% carbohydrates, 0.5 kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, The Netherlands) 3 hours prior to induction of anaesthesia and finished the ingestion within 1 hour
16284850|NCT00755729|Dietary Supplement|Preoperative Oral Carbohydrate|Patients in FSD group were fasted from midnight the night before surgery, and no preoperative oral carbohydrate loading
16284851|NCT00755716|Drug|Placebo (sugar pill)|patients receive
16284852|NCT00755716|Drug|Topiramate|25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper
16284853|NCT00755716|Drug|Nicotine patch|On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
16284854|NCT00755703|Biological|Pandemic Influenza Vaccine|Undetermined
16284855|NCT00755703|Biological|Placebo|
16284856|NCT00755690|Behavioral|High/ Low Phosphate diet|Low phosphate diet (750mg/day).
16284857|NCT00755690|Behavioral|High/ Low Phosphate diet|Low phosphate diet (750mg/day) with the addition of the phosphate binder aluminum hydroxide (500mg three times per day).
16284858|NCT00755690|Behavioral|High/ Low Phosphate diet|III. High phosphate diet (2000mg /day).
16284859|NCT00755677|Other|Pulses|subjects consume 1 pulse food daily for eight weeks
16284860|NCT00755664|Dietary Supplement|Low-dose complex B-vitamins|The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.
16284861|NCT00755651|Procedure|Endometrial biopsy|Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
16284862|NCT00755638|Biological|ACE-031|single subcutaneous dose of ACE-031
16284863|NCT00755599|Procedure|no-stirrup vaginal examination|Vaginal speculum examination done with feet on table extender.
16284864|NCT00755599|Procedure|Vaginal speculum examination done with stirrups.|Speculum examination done with feet in stirrups.
16284865|NCT00755586|Procedure|Mononuclear cell injection: 4 * 10e8 cells|350 ml bone marrow will be aspirated from the posterior iliac crest under general anesthesia in combination with a muscle tendon transposition surgery. Next, the patients will receive a bone marrow derived mononuclear cell injection of 4 * 10e8 cells in the m. biceps brachii.
16284866|NCT00755586|Procedure|Mononuclear cell injection: 8 * 10e8 cells|650 ml bone marrow will be aspirated from the posterior iliac crest under general anesthesia in combination with a muscle tendon transposition surgery. Next, the patients will receive a bone marrow derived mononuclear cell injection of 8 * 10e8 cells in the m. biceps brachii.
16284867|NCT00755586|Procedure|No mononuclear cell injection|Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.
16284868|NCT00755573|Drug|Pregabalin|Pregabalin 300 mg - 600 mg BID
16284869|NCT00755573|Drug|placebo|Regime as described for pregabalin
16284870|NCT00755560|Drug|Albendazole|Albendazole 10 - 15 mg/kg/day BID for 15 days
16284871|NCT00755560|Drug|Placebo|Placebo BID for 15 days
16284872|NCT00755547|Other|Aerobic Exercise Training|All sessions will be designed to elicit a certain degree of energy expenditure that will progressively increase throughout the trial. Adolescents randomized to the vigorous activity group will perform interval sessions that ensure an average heart rate between 70 and 85% of maximal heart rate reserve while those randomized will perform aerobic activity between 40 and 50% of heart rate reserve. The goal for the trial will be to expend a minimum of 350 kcal. The type of exercise will depend on the preference of each participant however, during the supervised sessions walking/jogging on a treadmill or outdoors will be used to elicit exercise intensities. The three activity sessions held at the YMCA-YWCA facilities in Winnipeg and be supervised by a trained kinesiologist who will record heart rate and perceived exertion for each session.
16284873|NCT00755534|Drug|Irinotecan|Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
16284874|NCT00755534|Drug|Capecitabine|Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression
16284875|NCT00755534|Drug|Cetuximab|Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression
16284876|NCT00755534|Drug|Oxaliplatin|Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression
16284877|NCT00755521|Drug|etoricoxib|"Treating Fibromyalgia with etoricoxib
~etoricoxib - 90mg"
16284878|NCT00755508|Drug|Ramelteon and gabapentin|Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.
16284879|NCT00755508|Drug|Ramelteon and gabapentin|Ramelteon 8 mg, tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.
16284880|NCT00755508|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.
16284881|NCT00755508|Drug|Gabapentin|Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.
16284882|NCT00755508|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.
16284883|NCT00755495|Drug|Ramelteon and doxepin|Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
16284884|NCT00755495|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.
16284888|NCT00755482|Drug|Placebo (maltodextran)|
16284889|NCT00755469|Procedure|Post-conditioning|The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.
16284890|NCT00755456|Drug|PD solution containing glucose|Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange. PD solutions are instilled for 120 days.
16284891|NCT00755456|Drug|PD solution containing glucose and L-carnitine|Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) and L-carnitine (0.1%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchanges. PD solutions are instilled for 120 days.
16284892|NCT00755443|Device|Drug eluting stent|Drug eluting stent implantation
16284893|NCT00755443|Device|Bare metal stent|
16284894|NCT00755417|Drug|Gabapentin Extended-Release (G-ER) 1200 mg|G-ER 1200 mg daily dosage given as two 600-mg tablets.
16284895|NCT00755417|Drug|Gabapentin Extended-Release (G-ER) 1800 mg|G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.
16284896|NCT00755417|Drug|Placebo|Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).
16284897|NCT00755404|Drug|PD Solution|Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange. PD solutions are instilled for 180 days.
16284898|NCT00755404|Drug|PD solution containing L-carnitine|Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) and L-carnitine (0.1%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchanges. PD solutions are instilled for 180 days.
16284899|NCT00755391|Behavioral|cognitive behavior therapy|The cognitive behavioral therapy used in this study will focus on developing patterns of regular eating, addressing body image issues, and ways to cope with situations that trigger eating disordered behaviors.
16284900|NCT00755391|Behavioral|Supportive Psychotherapy|The supportive psychotherapy treatment used in this study will involve identifying issues underlying your child's eating disorder and giving your child information about the psychological processes that tend to maintain or continue eating disorder symptoms.
16284901|NCT00755378|Drug|AZD8529|Oral
16284902|NCT00755378|Drug|Placebo|Oral
16284903|NCT00755352|Drug|pravastatin tablets and Welchol tablets|pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
16284904|NCT00755352|Drug|pravastatin tablets and Welchol placebo tablets|pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day
16284905|NCT00755326|Drug|HLXL|Two daily dosages will be investigated. Huo-Luo-Xiao-Ling (HLXL) dose (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks.
16284906|NCT00755313|Biological|trastuzumab|
16284907|NCT00755313|Drug|aromatase inhibition therapy|
16284908|NCT00755313|Drug|carboplatin|
16284909|NCT00755313|Drug|cyclophosphamide|
16284910|NCT00755313|Drug|docetaxel|
16284911|NCT00755313|Drug|doxorubicin hydrochloride|
16284912|NCT00755313|Other|metabolic assessment|
16284913|NCT00755313|Other|questionnaire administration|
16284914|NCT00755313|Other|study of socioeconomic and demographic variables|
16284915|NCT00755313|Procedure|cognitive assessment|
16284916|NCT00755313|Procedure|positron emission tomography|
16284917|NCT00755313|Radiation|fludeoxyglucose F 18|
16284918|NCT00755300|Procedure|Measurement of total thrombolic load|A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load
16284919|NCT00755287|Drug|insulin glargine|starting dose 10 IU daily
16284920|NCT00755287|Drug|metformin|As prescribed
16284921|NCT00755287|Drug|taspoglutide|10 mg once weekly
16284922|NCT00755287|Drug|taspoglutide|20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
16284923|NCT00755274|Biological|Influenza Virus Vaccine No Preservative: Pediatric Dose|0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
16284924|NCT00755274|Biological|Influenza Virus Vaccine No Preservative: Pediatric Dose|0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
16284925|NCT00755261|Drug|Avastin|Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
16284926|NCT00755261|Drug|Doxorubicin|The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
16284927|NCT00755248|Procedure|Coronary Artery Bypass Grafting|Coronary Artery Bypass Grafting on- or off-pump
16284928|NCT00755235|Other|Depression care management by secure messaging|Participants will receive electronic messages welcoming them and monitoring their antidepressant treatment. Care managers will use monitoring data to aid participants' physicians, coordinate physician follow-ups, facilitate emergency care, and facilitate specialty referrals. Care managers will also provide motivation and education to participants.
16284929|NCT00755222|Biological|AA4500|2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
16284930|NCT00755222|Biological|Placebo|2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.
16284931|NCT00755209|Drug|tranexamic acid|Loading 1 gram (~20 mg/kg) 100cc solution infuses in 30 minutes Maintenance 1 gram (~2.5 mg/kg/hr) 1000cc solution infuses in 8 hours
16284932|NCT00755196|Drug|AN2728|AN2728 Ointment, 5%, twice daily for 12 weeks
16284933|NCT00755196|Drug|Ointment vehicle|Ointment vehicle, twice daily for 12 weeks
16284934|NCT00755183|Drug|testosterone ophthalmic solution|testosterone ophthalmic solution for 128 days
16284935|NCT00755183|Drug|vehicle of testosterone ophthalmic solution|vehicle of testosterone ophthalmic solution for 128 days
16284936|NCT00755170|Drug|Vinorelbine|Metronomic vinorelbine (p.o) 30 mg total dose/day, every Monday, Wednesday and Friday of each week, continuously without intervals for the equivalence of 6 cycles maximum
16284937|NCT00755170|Drug|Bevacizumab|Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks for 6 cycles maximum followed by Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression
16284938|NCT00755157|Drug|Docetaxel|Metronomic docetaxel (IV) 30 mg/m2 on days 1, 8, 15 every 4 weeks for 6 cycles maximum
16284939|NCT00755157|Drug|Bevacizumab|Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks for 6 cycles maximum followed by (not compulsory) Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression
16284940|NCT00755144|Device|LCS Knee|Cementless total knee arthroplasty with LCS Knee
16284941|NCT00755144|Device|ROCC Knee|Cementless total knee arthroplasty with ROCC Knee
16284942|NCT00755131|Other|Exercise-based Cardiac Rehabilitation program|Trained patients attend the exercise training protocol for 6 months on hospital ambulatory-based regimen 3 times/week. Training sessions are supervised under continuous electrocardiography monitoring by a cardiologist, a physiotherapist and a graduate nurse. Each session is preceded by a 5-min warming-up and followed by a 5-min cooling-down. Exercise is performed for 30 min on a bicycle ergometer with the target of 60-70% of the peak oxygen consumption achieved at the initial symptom-limited cardiopulmonary exercise test. Exercise protocol is performed with a gradual increase in exercise workload until the achievement of the predefined target.
16284943|NCT00755118|Drug|Oxaliplatin|Oxaliplatin (I.V) 85mg/m2 on week 1 and week 3 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284944|NCT00755118|Drug|5-Fluorouracil|5-Fluorouracil (I.V) 1750mg/m2 on week 1,2,3 and 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284945|NCT00755118|Drug|Leucovorin|Leucovorin (I.V) 500mg/m2 on week 1,2,3 and 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284946|NCT00755118|Drug|Bevacizumab|Bevacizumab (I.V) 10mg/Kg on week 1 and week 3 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284947|NCT00755118|Drug|Irinotecan|Irinotecan (I.V) 110mg/m2 on week 2 and week 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284948|NCT00755118|Drug|Cetuximab|Cetuximab (I.V) 500mg/m2 on week 2 and week 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
16284949|NCT00755092|Behavioral|Doula|Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
16284950|NCT00755092|Behavioral|Doula|Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery
16284951|NCT00755079|Drug|extended release beta-2 adrenergic agonist|Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
16284952|NCT00755079|Drug|placebo|An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
16284953|NCT00755066|Drug|Fluticasone propionate|200 µg intranasal, 4 weeks, od.
16284954|NCT00755066|Drug|Placebo|Placebo intranasal spray
16284955|NCT00755053|Drug|Clotrimazole, vaginal ovule|Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
16284956|NCT00755053|Drug|Clotrimazole, vaginal tablet|Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
16284957|NCT00755040|Drug|cyclosporine ophthalmic emulsion|Given as eye drops
16284958|NCT00755040|Other|placebo|Given as eye drops
16284959|NCT00755027|Drug|Rasagiline|rasagiline 1 mg daily, oral use, during 12 weeks
16284960|NCT00755014|Other|red wine|One group (n=20) that consumed red wine (100 ml) daily for 3 weeks Another group (n=20) that consumed beer (250 ml) daily for 3 weeks
16284961|NCT00755001|Device|BiHapro hip stem with PPS Ti+Plasma HA|BiHapro hip stem with PPS Ti+Plasma HA
16284962|NCT00755001|Device|BiHapro hip stem with PPS Ti+BoneMaster HA|BiHapro hip stem with PPS Ti+BoneMaster HA
16284963|NCT00754988|Drug|Metformin|As prescribed
16284964|NCT00754988|Drug|Placebo (matching sitagliptin)|Once daily oral administration of placebo (matching sitagliptin).
16284965|NCT00754988|Drug|Placebo (matching taspoglutide)|Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
16284966|NCT00754988|Drug|Sitagliptin|Once daily oral administration of 100 mg of sitagliptin.
16284967|NCT00754988|Drug|Taspoglutide|Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
16284968|NCT00754975|Device|JACTAX LD DES|Drug Eluting Stent
16284969|NCT00754975|Device|TAXUS™ Libertè™ DES|Drug Eluting Stent
16284970|NCT00754962|Drug|protriptyline|10 mg tablet
16284971|NCT00754949|Drug|1% Azithromycin and 0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16284972|NCT00754949|Drug|1% Azithromycin|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16284973|NCT00754949|Drug|0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16284974|NCT00754936|Drug|Escitalopram|20 mg by mouth daily
16284975|NCT00754923|Drug|sorafenib|administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
16284976|NCT00754910|Drug|porfimer sodium|Given IV
16284977|NCT00754910|Procedure|bronchoscopy|Patients undergo bronchoscopy
16284978|NCT00754884|Drug|salmon calcitonin|daily intranasal 200 U.I. salmon calcitonin for periods of 14 days at a time
16284979|NCT00754884|Drug|intranasal saline solution plus glycerol|daily intranasal (one shot) saline solution plus glycerol for a period of 14 days
16284980|NCT00754871|Drug|Dienogest (81150037)|daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
16284981|NCT00754871|Drug|Dienogest (81150231)|daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
16284982|NCT00754871|Drug|Dienogest (SH T00660A)|daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
16284983|NCT00754871|Drug|Dienogest (81150746)|daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days
16284984|NCT00754858|Drug|belotecan hydrochloride|
16284985|NCT00754858|Drug|cisplatin|
16284986|NCT00754845|Drug|letrozole|Given orally
16284987|NCT00754845|Other|placebo|Given orally
16284988|NCT00754832|Drug|American ginseng extract HT-1001|Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.
16284989|NCT00754832|Drug|placebo|Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.
16284990|NCT00754819|Drug|Colchicine|1mg once daily
16284991|NCT00754819|Drug|Placebo|1 capsule daily
16284992|NCT00754793|Drug|escitalopram|10mg - 30mg daily titrated as tolerated over 12 weeks
16284993|NCT00754793|Drug|placebo|inactive comparator; titrated as per protocol over 12 weeks
16284994|NCT00754780|Drug|Pirfenidone|Capsule 800 mg TID, oral
16284995|NCT00754767|Drug|L-carnitine L-tartrate|Given orally
16284996|NCT00754767|Other|placebo|Given orally
16284997|NCT00754754|Procedure|Brain Retraction Monitoring Sensor|This is a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations.
16284998|NCT00754741|Behavioral|Adherence information|Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
16284999|NCT00754741|Behavioral|Adherence information plus motivational interviewing|Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
16285000|NCT00754728|Device|JACTAX DES|Drug Eluting Stent
16285001|NCT00754715|Drug|AZD2516|Solution administered once orally
16285002|NCT00754715|Drug|Placebo|Solution administered only once
16285003|NCT00754702|Drug|Vinorelbine|Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
16285004|NCT00754702|Drug|Lapatinib|Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity
16285005|NCT00754689|Drug|Rimonabant|Tablet, oral administration
16285006|NCT00754689|Drug|Metformin|Tablet, oral administration
16285007|NCT00754689|Drug|placebo|Tablet, oral administration
16285008|NCT00754663|Behavioral|exercise training|walking training at least 3 times a week
16285009|NCT00754650|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in single-use vials.
16285010|NCT00754624|Drug|Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler|Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
16285011|NCT00754585|Device|Logic Back Grahl Duo Back Model DB11-01|The device is placed against the back rest of a chair. The tension of the straps are adjusted for each participant to obtain the ENP.
16285012|NCT00754572|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv, every 4 weeks
16285013|NCT00754572|Drug|methotrexate|10-25mg oral or parenteral weekly.
16285014|NCT00754559|Drug|Tocilizumab|8mg/kg iv every 4 weeks
16285015|NCT00754546|Drug|Arformoterol tartrate|15 mcg in two ml solution administered via nebulizer
16285016|NCT00754546|Drug|Placebo: Normal Saline|Normal saline was nebulized.
16285017|NCT00754546|Other|Treadmill Exercise|
16285018|NCT00754546|Other|Cycle Exercise|
16285019|NCT00754533|Other|Continuous versus interval training|Influence of different exercise training programs
16285020|NCT00754520|Device|Ceramic On Metal|Ceramic on Metal articulation using M2a-38™ mm cup
16285021|NCT00754520|Device|Metal on Metal|Metal on Metal articulation using M2a-38™ mm cup
16285022|NCT00754507|Drug|colesevelam HCl tablets, and atorvastatin tablets|colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks
16285023|NCT00754507|Drug|colesevelam HCl placebo tablets and atorvastatin tablets|colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks
16285024|NCT00754494|Drug|erlotinib hydrochloride|Given PO
16285025|NCT00754494|Other|placebo|Given PO
16285026|NCT00754494|Other|laboratory biomarker analysis|Correlative studies
16285027|NCT00754481|Other|Normothermia|Patients randomized to the Normothermia arm (esophageal temp 36.5-37.5 ºC) were maintained at an esophageal temperature of 36.5-37.5ºC for 48 hours. Patients who were hypothermic (temperature < 35 ºC) when randomized to the normothermia group were rewarmed slowly using the servo-controlled mattress. Patients who were hyperthermic following randomization to the normothermia group were actively cooled to normothermia using the servo-controlled mattress. Neuromuscular blockers were administered as needed intravenously in both groups of patients to prevent shivering.
16285028|NCT00754481|Other|Hypothermia|Patients randomized to the Hypothermia arm (esophageal temp 33º to 34 °C) were cooled rapidly using the cooling protocol developed for the Hypothermia Paediatric Head Injury Trial. A temperature probe was placed in the esophagus and its position confirmed using a chest radiograph. Patients were placed on a servo-controlled cooling blanket and covered in crushed ice (in sealed plastic bags covered by pillow cases) and a second cooling blanket. Once the esophageal temperature reached 34.0ºC, the ice and second cooling blanket was removed and esophageal temperature was maintained at 33º to 34 °C for 48 hours using the servo-controlled cooling mattress. Patients treated with ECMO were cooled using the extracorporeal circuit cooling-device. Rewarming was done at a rate of 0.5 ºC every 2 hours until an esophageal temperature of 36.5 ºC was reached. Thereafter temperature was recorded but not controlled by surface cooling.
16285029|NCT00754468|Device|Cryo Spray Ablation|Cryo Spray Ablation 4 cycles x 10 seconds treatment
16285030|NCT00754468|Device|Cryo Spray Ablation|Cryo Spray Ablation 2 cycles x 20 seconds
16285031|NCT00754455|Biological|Influenza VLP Vaccine (recombinant)|Single injection Day 0; 0.5mL
16285032|NCT00754455|Biological|Placebo|Placebo as a single injection of 0.5 mL.
16285033|NCT00754442|Drug|Teriparatide|"Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both patients and controls"
16285034|NCT00754429|Drug|losartan|losartan 50mg qd for 30 weeks.
16285035|NCT00754429|Drug|amlodipine|amlodipine 5 mg q.d for 30 weeks.
16285036|NCT00754403|Drug|Pioglitazone and metformin|Pioglitazone 30 mg, tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
16285037|NCT00754403|Drug|Metformin|Pioglitazone placebo-matching tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
16285038|NCT00754390|Dietary Supplement|Moderate Calcium, Low phytate Diet|Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks
16285039|NCT00754390|Dietary Supplement|Moderate Calcium, High Phytate Diet|Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks
16285040|NCT00754390|Dietary Supplement|High Calcium, Low Phytate Diet|Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks
16285041|NCT00754390|Dietary Supplement|High Calcium, High Phytate Diet|Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks
16285042|NCT00754377|Other|PBLI Curriculum|PBLI curriculum was offered on alternate rotations
16285043|NCT00754364|Drug|Pemetrexed/Carboplatin|"Patients will receive Pemetrexed intravenous infusion (i.v.) via infusion pump or gravity drip, at a dose of 500 mg/m2 (over a target of 10 minutes). Pemetrexed should be administered every 21 days on the same day.
~Patients will receive carboplatin intravenous continuous infusion (i.v.) over 30 minutes via infusion pump or gravity drip, at a dose of AUC5. Carboplatin should be administered every 21 days on the same day."
16285044|NCT00754364|Drug|Gemcitabine|Patients will receive gemcitabine 1250 mg/m2 as a 30 minutes intravenous infusion on days 1 and 8 and of a 21-day cycle.Patients may continue to receive gemcitabine for up to a maximum of 6 cycles.
16285045|NCT00754351|Drug|Bevacizumab|Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
16285046|NCT00754351|Drug|Docetaxel|Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
16285047|NCT00754351|Drug|Gemcitabine|Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
16285048|NCT00754338|Drug|Alcon Opti-Free® RepleniSH® with Supraclens®|Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
16285049|NCT00754338|Drug|Alcon Opti-Free® RepleniSH®|Marketed Multipurpose Disinfecting Care System
16285050|NCT00754338|Drug|B&L ReNu MultiPlus™|Marketed Multipurpose Disinfecting Care Systems
16285051|NCT00754325|Drug|Dasatinib|Tablets, Oral, 100 mg, once daily (QD), upto 2 years
16285052|NCT00754325|Drug|Fulvestrant|Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years
16285053|NCT00754312|Drug|SNDX-275|
16285054|NCT00754286|Other|Aromatherapy Scented Wand|"The aromatherapy used in this will be Quease Ease™, manufactured by Soothing Scents, Inc. Quease Ease is a blend of lavender, spearmint, ginger, and peppermint soaked into a pad placed within a wand dispenser that emits a fragrance when placed within a few inches of the nares. Participants will be given aromatherapy wand at the onset of their chemotherapy treatment. Participants will be instructed how to self-administer the aromatherapy treatment. Specifically, they can hold the wand under their nose and breathe in deeply five times when they feel symptoms of nausea or anxiety."
16285055|NCT00754286|Other|Placebo wand|Placebo wands will look identical to the scented wands but will not contain a scent. Participants will be given the placebo wand at the onset of their chemotherapy treatment. Participants will be instructed how to self-administer the placebo treatment. Specifically, they can hold the wand under their nose and breathe in deeply five times when they feel symptoms of nausea or anxiety.
16285056|NCT00754273|Other|etest susceptability testing|E-test methodology is performed on all MRSA samples using standardized inoculum (0.5 McFarland) for Tigecycline, Vancomycin, Teicoplanin, and Linezolid. E test is performed using heavy inoculum for Vancomycin and Teicoplanin (2.0 McFarland).
16285057|NCT00754260|Behavioral|Caffeine reduction|patients are randomized to receive caffeine reduction counseling versus no caffeine reduction counseling
16285058|NCT00754247|Drug|0.5% hydrocortisone, silicone, vitamin E lotion|0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing.
16285059|NCT00754247|Drug|Onion extract gel|Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
16285060|NCT00754247|Drug|Cetearyl alcohol lotion|Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion.
16285061|NCT00754234|Behavioral|My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7|Iron absorption measured from one of seven different menus fed for 1 day each, in randomized order for each subject, with feedings separated by 2 weeks
16285062|NCT00754221|Drug|[S,S]-Reboxetine|Once a day, oral treatment, of 4, 6, 8 or 10 mg
16285063|NCT00754208|Drug|methylphenidate|Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.
16285064|NCT00754195|Other|Thoracic epidural catheter|Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
16285065|NCT00754182|Device|Octylcyanoacrylate (Dermabond)|Synthetic glue for surgical use (skin closure)
16285066|NCT00754182|Device|Subcuticular reabsorbable suture (Caprosyn)|Every stitch is positioned in the subcuticular tissue by a continuous technique
16285067|NCT00754156|Device|ABRA Abdominal Closure System|ABRA Abdominal Closure System
16285068|NCT00754156|Device|V.A.C. Therapy|V.A.C. Therapy Alone
16285069|NCT00754156|Device|KCI ABThera|KCI ABThera
16285070|NCT00754143|Drug|FG-3019|Placebo every 2 weeks IV for all infusions
16285071|NCT00754143|Drug|FG-3019|FG-3019 5 mg/kg every 2 weeks IV for all infusions
16285072|NCT00754143|Drug|FG-3019|FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
16285073|NCT00754130|Drug|Placebo|Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
16285074|NCT00754130|Drug|MK-0941|MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
16285075|NCT00754104|Drug|ABT-869|0.25 mg/kg. daily.
16285076|NCT00754104|Drug|Tarceva|150mg, daily.
16285077|NCT00754091|Device|Polymer based lubricating liquid|three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
16285078|NCT00754078|Radiation|Tomotherapy|30 fractions of tomotherapy treatment
16285079|NCT00754065|Drug|Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
16285080|NCT00754065|Drug|Ortho Tri Cyclen Lo|Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
16285081|NCT00754052|Drug|Aricept (donepezil hydrochloride)|All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally.
16285082|NCT00754052|Drug|Aricept (donepezil hydrochloride)|All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) donepezil. All doses will be administered orally.
16285083|NCT00754052|Drug|Placebo|All participants will start with a dose of 2.5 mg/day (2.5 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) placebo. All doses will be administered orally.
16285084|NCT00754039|Drug|colesevelam HCl tablets and fenofibrate tablets|Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
16285085|NCT00754039|Drug|fenofibrate tablets and Welchol placebo tablets|fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
16285086|NCT00754039|Drug|fenofibrate tablets and Welchol placebo tablets|fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
16285087|NCT00754026|Procedure|Insertion of interscalene catheter for shoulder surgery|Distance of interscalene catheter: 2cm
16285088|NCT00754026|Procedure|Insertion of interscalene catheter for shoulder surgery|Distance of interscalene catheter: 6cm
16285089|NCT00754013|Drug|Aricept (Donepezil hydrochloride)|"All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil.
~All doses will be administered orally."
16285090|NCT00754013|Drug|Placebo|"All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) placebo.
~All doses will be administered orally."
16285091|NCT00754000|Other|Observation|AE monitoring and EPIC QOL survey
16285092|NCT00753987|Drug|Hypertonic Saline|5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.
16285093|NCT00753961|Other|fermented dairy product|fermented dairy product (2 bottles/day during 16 weeks)
16285094|NCT00753961|Other|non fermented dairy product|non fermented dairy product (2 bottles/day during 16 weeks)
16285095|NCT00753948|Drug|N-Nitro L-arginine-methylester (L-NAME)|A non-specific inhibitor of the nitric oxide synthase enzyme.
16285096|NCT00753935|Drug|enteric-coated aspirin|enteric-coated aspirin 81mg daily for 2 weeks
16285097|NCT00753935|Drug|Chewable aspirin|chewable aspirin 81mg daily for 2 weeks
16285098|NCT00753922|Device|Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface|Two types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.
16285099|NCT00753909|Drug|Carboplatin|Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles
16285100|NCT00753909|Drug|Bevacizumab|Bevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
16285101|NCT00753909|Drug|Paclitaxel|Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles
16285102|NCT00753896|Drug|exenatide|subcutaneous injection, 2.0mcg, once weekly
16285103|NCT00753883|Drug|simvastatin|simvastatin 20 mg/QD for 6 Weeks.
16285104|NCT00753883|Drug|Ezetimibe|Ezetimibe 10 mg/QD for 8 weeks.
16285105|NCT00753870|Biological|CCRE inhalation|20,000 EU CCRE given as a one-time challenge
16285106|NCT00753857|Other|Drug Facts Box|Educational intervention of 1 page summary of drug efficacy and side effects
16285107|NCT00753857|Other|Standard Brief Summary|Ads consisted of the standard second page called the brief summary
16285108|NCT00753844|Biological|URLC10|Biological: URC10 Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection.
16285109|NCT00753831|Procedure|Aurosling|Silicon rod to be used in frontalis suspension surgery
16285110|NCT00753818|Other|DHA and ARA|various levels of DHA and ARA
16285111|NCT00753818|Other|Control|
16285112|NCT00753805|Dietary Supplement|mare's milk|The participants received 250 ml mare's milk or placebo daily. The placebo drink was based on a hypoallergenic infant formula.
16285113|NCT00753792|Drug|methylprednisolone|methylprednisolone 1.000 mg/day intravenous administration during three days
16285114|NCT00753792|Drug|methylprednisolone|methylprednisolone 1.250 mg/day orally administered during three days
16285115|NCT00753792|Drug|Placebo|Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
16285116|NCT00753779|Drug|colesevelam HCl tablets, and simvastatin tablets|colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
16285117|NCT00753779|Drug|simvastatin tablets and colesevelam HCl placebo|simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
16285118|NCT00753766|Other|Multifactorial Intervention|
16285119|NCT00753740|Drug|IT-101 (12mg/m2/dose)|Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.
16285120|NCT00753740|Drug|IT-101 (15mg/m2/dose)|Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.
16285121|NCT00753740|Drug|5% Dextrose (Placebo)|Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.
16285122|NCT00753727|Drug|Sunitinib malate|Sunitinib dose 50 mg/day orally for 2 weeks prior to radiotherapy. Treatment Dose Levels during radiotherapy: Dose level 0: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 25mg/day given concurrently with radiotherapy; Dose level 1: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy; Dose level -1: Sunitinib 37.5mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy. Dose escalation/de-escalation: first 6 patients will be accrued at dose level 0. The dose levels at which subsequent patients will be accrued will be determined using a dose modification schedule.
16285123|NCT00753727|Radiation|Radiotherapy|Preoperative radiotherapy consisting of external beam radiotherapy at a dose of 50.4 Gy given in 28 fractions, five days a week, over five weeks and 3 days to the planning target volume.
16285124|NCT00753714|Drug|ZD6474, Vandetanib|100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285125|NCT00753714|Drug|Placebo to Match ZD6474, Vandetanib|100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285126|NCT00753714|Drug|Gemcitabine|administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285127|NCT00753688|Drug|PAZOPANIB|800 mg once daily orally
16285128|NCT00753688|Drug|Placebo|matching placebo 800 mg once daily orally
16285129|NCT00753675|Drug|ZD6474, Vandetanib|300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285130|NCT00753675|Drug|ZD6474, Vandetanib|100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285131|NCT00753675|Drug|Gemcitabine|administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285132|NCT00753675|Drug|Placebo matching ZD6474|Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285133|NCT00753662|Device|1Hz TMS with H2 coil|1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
16285134|NCT00753662|Device|10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex|10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
16285135|NCT00753662|Device|SHAM TMS with H2 coil|SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex
16285136|NCT00753649|Biological|Infanrix™ hexa|Intramuscular, three doses
16285137|NCT00753636|Drug|Dynacirc CR (Isradipine)|Dynacirc CR is given by the recommended schedule for titration. Subjects start on a 5mg dose and are increased in increments of 5mg every 2 weeks provided that the subjects do not have significant adverse events or symptomatic orthostatic hypotension.
16285138|NCT00753623|Drug|Ramelteon|ramelteon (8 mg)
16285139|NCT00753623|Drug|Placebo|In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.
16285140|NCT00753597|Drug|Solu-medrone, Mabthera|125mg, 1gram, twice day 1 and day 15
16285141|NCT00753571|Drug|Cistanche Total Glycosides|"Drug: Cistanche Total Glycosides Cistanche Total Glycosides ,1.8g/day(6 capsules) po Qd*9months Arms: 1 Drug: blank capsules 6 capsules po Qd*9months
~Arms: 2"
16285142|NCT00753558|Drug|Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.|"Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel.
~Arm #2: Oral placebo solutions, placebo buccal gel."
16285143|NCT00753545|Drug|AZD2281|Oral 400mg bid
16285144|NCT00753545|Drug|matching placebo|matching placebo bid
16285145|NCT00753532|Dietary Supplement|200mg of Palm vitamin E (tocotrienols) or placebo|Individuals randomized in the (MRI+ve) and (MRI -ve) cohort received either 200 mg softgels of Palm Vitamin E (tocotrienols) or placebo taken orally twice a day.
16285146|NCT00753519|Device|Real iTBS|Real iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.
16285147|NCT00753519|Device|Sham iTBS|Sham iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.
16285148|NCT00753506|Dietary Supplement|Artemisinin|100 mg of artemisinin twice per day for 10 weeks
16285149|NCT00753506|Dietary Supplement|Identical looking placebo capsule|Identical looking placebo twice per day for 10 weeks
16285150|NCT00753493|Drug|intravenous topiramate|Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate
16285151|NCT00753480|Drug|D4064A|
16285152|NCT00753467|Drug|IFN-γ 1b (Actimmune)|IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose
16285153|NCT00753467|Drug|Adefovir dipivoxil|Adefovir dipivoxil: 1 tablet of 10mg given orally QD
16285238|NCT00752856|Drug|Kaletra + Isentress|kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day
16285154|NCT00753467|Drug|IFN-γ 1b and Adefovir dipivoxil combination|IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose Adefovir dipivoxil: 1 tablet of 10mg given orally QD
16285155|NCT00753454|Drug|Certolizumab pegol|Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 & Week 4, followed by 200 mg every 2 weeks).
16285156|NCT00753441|Procedure|Surgical bypass|Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
16285157|NCT00753441|Procedure|Endoscopic stenting|Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)
16285158|NCT00753428|Other|Community-based Survey|"Questionnaires will be used to record detailed information regarding demographic and socioeconomic characteristics, maternal medical history, recent obstetrical history (including access to preventive services for mother-to-child HIV transmission), and infant medical history. Infant deaths will also be recorded as part of the survey. In cases where either the mother or infant has died, we will perform verbal autopsy interviews (Appendix 5) with surviving family members to determine cause of death and gather information regarding HIV infection and/or exposure.
~Heel/finger pricks will be taken so as to perform dried blood spot cards, and test for HIV in children and adults."
16285159|NCT00753415|Biological|V935|A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10^9 vector genomes/mL) or a HD (1 x 10^11 vector genomes/mL).
16285160|NCT00753415|Biological|V934-EP|A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).
16285161|NCT00753402|Biological|Endotoxin, Lipopolysaccharide, LPS|Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
16285162|NCT00753402|Biological|Endotoxin, Epinephrine|Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes/Epinephrine 30mcg/kg/min
16285163|NCT00753389|Other|None (anesthesia)|anesthesia
16285164|NCT00753363|Other|Weight Loss|6 months of weight loss
16285165|NCT00753363|Other|Aerobic Exercise Training|6 months of aerobic exercise training
16285166|NCT00753350|Device|Sensate™ anchored gastric device|Delivery/anchoring of the Sensate™ device in the stomach. Withdrawal of the Sensate™ device and its anchoring components after 8 weeks.
16285167|NCT00753337|Device|Assurant® Cobalt Iliac Stent System|Iliac Stenting
16285168|NCT00753324|Drug|Routine three-drug antiretroviral prophylaxis|Women who are identified as HIV-infected will be offered routine combination antiretroviral prophylaxis starting at 28 weeks gestation (timing consistent with Zambian national guidelines for short-course ZDV). The first-line combination provided to pregnant women will be standardized following consultation with the Ministry of Health, but will likely include ZDV, lamivudine (3TC) and either NVP or lopinavir / ritonavir. In women who with moderate to severe anemia, ZDV is substituted with stavudine (d4T). In accordance with the Zambian national guidelines, any patients who are started on NVP will begin with a once daily dose for two weeks before increasing to the regular twice daily schedule
16285169|NCT00753311|Drug|rizatriptan or placebo|Patient took 1 rizatriptan 10 mg wafer or placebo as soon as their migraine headache became of moderate or severe intensity.
16285170|NCT00753298|Device|LoFric Primo (POBE) single-use urinary catheter|LoFric Primo (POBE) single-use urinary catheter
16285171|NCT00753298|Device|LoFric Primo (PVC) single-use urinary catheter|LoFric Primo (PVC) single-use urinary catheter
16285172|NCT00753285|Device|Renal Denervation|
16285173|NCT00753272|Biological|GSK Bio's influenza vaccine GSK2186877A|IM administration, two times one annual dose, 3 different lots will be tested
16285174|NCT00753272|Biological|Fluarix TM|IM administration, two times one annual dose
16285175|NCT00753259|Other|AF Clinic|Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment
16285176|NCT00753259|Other|Care as Usual|Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.
16285177|NCT00753246|Drug|nimotuzumab|monoclonal antibody
16285178|NCT00753220|Biological|VDC2008|"Intratumoral injection of VDC2008 post-cryotherapy.
~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8 cells"
16285179|NCT00753220|Drug|Cyclophosphamide|Cyclophosphamide i.v. given at day -3 (dose: 300mg/m2); Low-dose Cyclophosphamide pill given twice daily (dose: 25 mg, p.o., b.i.d. for 7 days on and 7 days off; a total of 6 cycles [1 cycle = 4 weeks] starting Week 2 after cryoablation and going to Week 26)
16285180|NCT00753207|Drug|epirubicin hydrochloride|
16285181|NCT00753207|Drug|lapatinib ditosylate|
16285182|NCT00753207|Other|biomarker analysis|
16285183|NCT00753207|Other|immunohistochemistry staining method|
16285184|NCT00753207|Other|liquid chromatography|
16285185|NCT00753207|Other|mass spectrometry|
16285186|NCT00753181|Other|Nutritional Formula|nutritional shake daily
16285187|NCT00753181|Other|Usual diet|usual dietary habits
16285188|NCT00753181|Other|Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.|nutritional shake, diabetes specific cereal and diabetes snack bar daily
16285189|NCT00753168|Drug|OT-730 ophthalmic solution|one eye drop twice daily
16285190|NCT00753168|Drug|timolol maleate ophthalmic solution|one eye drop twice daily
16285191|NCT00753168|Drug|OT-730 placebo|one eye drop twice daily
16285192|NCT00753155|Behavioral|exercise training; psychosocial support|supervised home-based endurance training; recommendation to exercise every other day; psychosocial support
16285193|NCT00753142|Drug|Intralipid 20%|Participants receive a 48-hour infusion with Intralipid at 40 milliliters per hour (mL/hr).
16285194|NCT00753142|Drug|Glucose infusion|Participants receive a glucose infusion consisting of 10% dextrose infused intravenously at a rate of 200 mg/m^2/min for 20 hours.
16285195|NCT00753129|Procedure|Prone position with head elevation|Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)
16285196|NCT00753116|Device|Renal Denervation with a catheter-based procedure|Disruption of the renal nerves with a catheter-based procedure
16285197|NCT00753103|Biological|Infliximab|5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
16285198|NCT00753103|Drug|Cyclophosphamide|Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
16285199|NCT00753103|Drug|Prednisolone|Daily oral 1mg/kg tapered over 12 months
16285200|NCT00753103|Drug|Azathioprine|Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
16285201|NCT00753103|Procedure|Plasma exchange|Additional therapy for patients with severe vasculitis (creatinine > 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
16285202|NCT00753103|Drug|Mycophenolate mofetil|Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
16285203|NCT00753103|Drug|Methylprednisolone|500 mg intravenous infusion daily for three days at lead physicians discretion.
16285204|NCT00753090|Device|Vanguard™ Deep Dish Rotating Platform Knee|Vanguard™ Deep Dish Rotating Platform Knee
16285205|NCT00753090|Device|Vanguard™ Cruciate Retaining Knee|Vanguard™ Cruciate Retaining Knee
16285206|NCT00753064|Drug|Antiscorpion venom serum(AScVS).|"AScVS therapy group
~If the score is 5 and if the patient belongs to pediatric group(>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes.
~According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below:
~Vials of AScVS Composite score Child Adult 5-10 2 4 > 10-15 3 6 >15- 21 4 8"
16285207|NCT00753064|Drug|T.Prazosin|Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.
16285208|NCT00753064|Drug|AScVS + Prazosin|Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.
16285209|NCT00753051|Drug|clozapine+haloperidol|clozapine 300-900 mg/d haloperidol 4-60 mg/d
16285210|NCT00753051|Drug|clozapine,electroconvulsive therapy|clozapine 300-900 mg/d electroconvulsive therapy 4-12 times
16285211|NCT00753038|Biological|REOLYSIN®|3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
16285212|NCT00753038|Drug|Carboplatin|5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
16285213|NCT00753038|Drug|Paclitaxel|175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
16285214|NCT00753025|Procedure|Bone marrow aspiration, injection of cells|"Bone marrow is aspirated at patients in all arms.
~Arm TNC receives injection of total nucleated cells into ischemic muscle"
16285215|NCT00753025|Procedure|Bone marrow aspiration , injection of isolated CD 133+ cells|"arm CD133 receives injection of isolated CD 133+ cells"
16285216|NCT00753025|Procedure|Bone marrow aspiration, injection of saline|"arm placebo receives injection of saline"
16285217|NCT00753012|Drug|Lisdexamfetamine|Lisdexamfetamine daily until the completion of participation in the clinical trial (up to Week 11 or final study visit). Subjects will start on 30 mg of LDX per day for the first week of treatment. The dose will be increased weekly in 20 mg increments, up to a 70 mg daily (maximum). If significant adverse effects (AE) occur, the daily dose may be reduced by 20 mg. At subsequent visits, a higher dose may be resumed if tolerated. Both cohorts of the study will follow the same treatment plan.
16285218|NCT00752999|Drug|Fostamatinib Disodium (R935788)|150 mg tablet, oral, twice-a-day
16285219|NCT00752999|Drug|Placebo|Placebo tablet, oral, twice-a-day
16285220|NCT00752986|Drug|ZD6474 (Vandetanib at the dose of 100 mg)|100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285221|NCT00752986|Drug|Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)|Placebo of 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285222|NCT00752986|Drug|Fulvestrant|All patients will receive fulvestrant Loading Dose (LD). The Loading Dose regimen is 500mg (2 injections) at day 1, followed by 250mg at day 14, 28 and every 28 days thereafter.
16285223|NCT00752986|Drug|ZD6474 (Vandetanib at the dose of 300 mg)|300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.
16285224|NCT00752986|Drug|Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)|Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
16285225|NCT00752973|Drug|MALG (malathion) Treatment|MALG applied for 30 minutes
16285226|NCT00752947|Drug|moxifloxacin|Moxifloxacin 400mg iv. OD followed by moxifloxacin 400mg OD orally, 2-4 weeks.
16285227|NCT00752947|Drug|levofloxacin|Levofloxacin 400mg i.v. OD followed by oral levofloxacin 400mg OD, 2-4 weeks
16285228|NCT00752947|Drug|metronidazole|metronidazole 0.5g i.v. bid followed by oral metronidazole 0.2g tid, 2-4 weeks
16285229|NCT00752934|Drug|oral baclofen + placebo|"Group A will be given 13 weeks of oral baclofen followed by a 2-week non-treatment (washout) period, and then 13 weeks of oral placebo.
~For participants who with weight under 15 Kg at the time of enrolment, the initial oral baclofen dose will be 2.5 mg daily, increasing weekly over a 7-week period to 10 mg three times a day, and will be continued at that dose for the following 5 weeks.
~For those participants who will be over 15 Kg at the time of enrollment, the starting oral baclofen dose will be 5 mg daily, increasing over a 9-week period to 20 mg three times a day, and will be continued for the next 3 weeks at that dose. At the end of each 12-week period, the drug (either baclofen or placebo) will be tapered over 6 days.
~Children's carers will given information on possible side effects, and asked to contact one of the researchers if any adverse events occur."
16285230|NCT00752934|Drug|placebo + oral baclofen|Group B will receive 13 weeks of oral placebo followed by 2-week nontreatment, and then 13 weeks of oral baclofen
16285231|NCT00752921|Drug|etoricoxib|120 mg
16285232|NCT00752921|Drug|placebo|placebo
16285233|NCT00752895|Dietary Supplement|American ginseng|Given orally
16285234|NCT00752895|Dietary Supplement|Placebo|Given orally
16285235|NCT00752882|Drug|ceftazidime|
16285236|NCT00752869|Drug|dutasteride|0.5mg by mouth one time per day for 1 year
16285237|NCT00752869|Drug|placebo|one tablet per day for 1 year
16285239|NCT00752856|Drug|Atripla|Atripla 1 tab once a day
16285240|NCT00752843|Drug|mifepristone + fluvastatin|Subjects will receive a single oral dose of 40 mg PO of fluvastatin on three occasions: alone (Day 1), at the same time as a single dose of CORLUX 1200 mg (Day 8) and during concomitant administration of CORLUX 1200 mg/day (CORLUX on Days 8-14, fluvastatin on Day 14).
16285241|NCT00752830|Drug|AZD0328|Oral capsule, single dose
16285242|NCT00752817|Other|Proficiency-based virtual reality simulation training|Subjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case
16285243|NCT00752817|Other|Training under the current surgical training programme|Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.
16285244|NCT00752804|Procedure|Dialysis during 4 hours|Blood and dialysate sampling
16285245|NCT00752804|Procedure|Dialysis during 6 hours|Blood and dialysate sampling
16285246|NCT00752804|Procedure|Dialysis during 8 hours|Blood and dialysate sampling
16285247|NCT00752791|Drug|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
16285248|NCT00752778|Other|pet-scan FDG-F18|
16285249|NCT00752739|Dietary Supplement|selenium|Given orally
16285250|NCT00752739|Other|placebo|Given orally
16285251|NCT00752726|Drug|Orlistat|Weight loss treatment
16285252|NCT00752726|Drug|Placebo|Inactive
16285253|NCT00752713|Procedure|cardiac MRI|cardiac MRI at one time point for group 1 after intervention for group 2 at any time point
16285254|NCT00752700|Other|Conventional resistance training|Conventional resistance training program (CRT)
16285255|NCT00752700|Other|Whole body vibration resistance training|Whole body vibration resistance training (WBV) on the FITVIBE-platform
16285256|NCT00752687|Drug|ABT-072|Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
16285257|NCT00752687|Drug|placebo|Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
16285258|NCT00752674|Other|Neuromuscular balance|
16285259|NCT00752661|Drug|Tramadol Hydrochloride; JNS013|
16285260|NCT00752648|Drug|TMC435350|
16285261|NCT00752635|Drug|Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol|
16285262|NCT00752622|Biological|Infliximab 5 mg/kg|Participants received Infliximab 5 mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase. At Week 10, those who were in clinical response received further treatment every 8 weeks during the observational phase
16285263|NCT00752622|Biological|Infliximab 5 mg/kg every 6 weeks|Participants with loss of response in the observational phase were randomized at entry into the interventional phase received 5 mg/kg IV every 6 weeks (shortened interval group)
16285264|NCT00752622|Biological|Infliximab 7 mg/kg every 8 weeks|Participants with loss of response in the observational phase were randomized at entry into the interventional phase received 7 mg/kg IV every 8 weeks (increased dose group)
16285265|NCT00752609|Drug|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
16285266|NCT00752596|Drug|Azimilide 2HCl|One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated
16285267|NCT00752583|Procedure|Peritoneal dialysis|Blood, urine and dialysate sampling
16285268|NCT00752583|Procedure|Haemodialysis|Blood, urine and dialysate sampling
16285269|NCT00752570|Drug|AMG 386|AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
16285270|NCT00752570|Drug|AMG 386 Placebo|AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
16285271|NCT00752570|Drug|FOLFIRI|"Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386.
~FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours.
~FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest."
16285272|NCT00752557|Drug|rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)|Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
16285273|NCT00752557|Drug|rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)|Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
16285274|NCT00752557|Drug|bisphosphonates, calcium, and vitamin D|Oral bisphosphonate therapy
16285275|NCT00752544|Drug|TMC435350|
16285276|NCT00752531|Behavioral|Home Automated Telemanagement (HAT)|The HAT was designed as an Internet-based telemedicine system that (1) provides ongoing education to patients about their chronic disease, (2) helps patients follow their self-care plans, and (3) helps health care practitioners monitor their patients' self-management processes according to current clinical guidelines. During each telecommunication session, patients perform self-testing and receive structured disease-specific education, patient-tailored counseling, and advice on how to follow their individual self-care plans based on the current results of self-testing.
16285277|NCT00752518|Drug|bortezomib|
16285278|NCT00752505|Drug|Esreboxetine|Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
16285279|NCT00752505|Drug|Esreboxetine|Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
16285280|NCT00752492|Other|Isocapnic Hyperpnoea|IH is a method of increasing alveolar ventilation (Va) while preventing the unwanted hypocapnia by addition of CO2 to the inhaled mixture.
16285954|NCT00747175|Drug|AZD1656|Dose titration of oral suspension to a tolerable dose, 1 month treatment
16285281|NCT00752479|Biological|Mesenchymal stem cells infusion, Basiliximab,Methylprednisolone,RATG ,Cyclosporine ,Mycophenolate mofetil|"Cell therapy
~Mesenchymal cells infusion.
~Induction therapy:
~Basiliximab (20 mg i.v.day 0 and day 4 post-tx). Low dose RATG (0.5 mg/kg/day i.v. day 0-6 post-tx). Methylprednisolone (500 mg to 25 mg from day 0 to 6 post-tx. Then stop).
~Maintenance therapy:
~Cyclosporine (from day 0: dose according to target trough blood level). Mycophenolate mofetil (750 mg b.i.d. from day 1 post-tx)."
16285282|NCT00752479|Drug|Basiliximab, Methylprednisolone,RATG,Cyclosporine,Mycophenolate mofetil|"Routine immunosuppressive therapy
~Induction therapy:
~Basiliximab (20 mg i.v.day 0 and day 4 post-tx). Low dose RATG (0.5 mg/kg/day i.v. day 0-6 post-tx). Methylprednisolone (500 mg to 25 mg from day 0 to 6 post-tx. Then stop).
~Maintenance therapy:
~Cyclosporine (from day 0: dose according to target trough blood level). Mycophenolate mofetil (750 mg b.i.d. from day 1 post-tx)."
16285283|NCT00752466|Drug|Topiramate; flunarizine|
16285284|NCT00752453|Procedure|Dialysis during 4 hours|Blood and dialysate sampling
16285285|NCT00752453|Procedure|Dialysis during 6 hours|Blood and dialysate sampling
16285286|NCT00752453|Procedure|Dialysis during 8 hours|Blood and dialysate sampling
16285287|NCT00752440|Other|Inspiratory muscle training (IMT)|IMT (30 min 7 times per week, for 8 weeks)
16285288|NCT00752427|Drug|Paliperidone ER OROS®|
16285289|NCT00752414|Drug|MP-376 (Levofloxacin solution for Inhalation)|Daily for 5 days
16285290|NCT00752414|Drug|Placebo|same frequency as MP-376
16285291|NCT00752401|Drug|Cholecalciferol|6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day.
16285292|NCT00752401|Drug|Placebo|An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.
16285293|NCT00752375|Drug|Trimethoprim Sulfamethoxazole|"Children >3months of age will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)per day for one year.
~Children under 3 months of age will receive amoxicillin 10mg/kg once per day for one year.
~Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day for one year."
16285294|NCT00752375|Drug|placebo|"Placebo matching Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)for children more than 3 months of age
~Placebo matching amoxicillin 10mg/kg once per day for children under 3 months of age
~Placebo matching nitrofurantoin (1mg/kg) once per day for children with a sulfa allergy."
16285295|NCT00752362|Device|Milennium Matrix® (Control)|Percutaneous coronary intervention with bare metal stent
16285296|NCT00752362|Device|Infinnium®|Percutaneous coronary intervention with paclitaxel-eluting stent
16285297|NCT00752362|Device|Supralimus®|Percutaneous coronary intervention with sirolimus-eluting stent
16285298|NCT00752349|Procedure|Ultrasound|To evaluate oral phase swallowing function using submental ultrasound
16285299|NCT00752336|Behavioral|exercise training; psychosocial support|supervised home-based endurance training; recommendation to exercise every other day
16285300|NCT00752323|Drug|aminolevulinic acid|Given orally
16285301|NCT00752323|Procedure|Surgical Resection|Surgical resection - 6 biopsies from 3 fluorescent regions
16285302|NCT00752310|Drug|Darunavir|
16285303|NCT00752297|Drug|Preservative-free Saline|Subjects will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 0.5 mL of the placebo (preservative-free saline).
16285304|NCT00752297|Drug|Mentor Purified Toxin|All subjects will receive five 0.1 mL intramuscular injections (two in each corrugator and one in the procerus muscle) at each Treatment Visit. The total treatment dose (sum of the five injections) to be administered will be 30 U of PurTox. Subjects will have many Treatment Visits throughout the course of the three-year study.
16285305|NCT00752284|Procedure|Coronectomy|Coronectomy Group. Removal of crown of lower wisdom tooth, trim down root below crestal bone and primary closure
16285306|NCT00752284|Procedure|Total Excision|Total excision of lower third molar
16285307|NCT00752258|Drug|Mentor Purified Toxin Botulinum Toxin Type A|All subjects will receive five 0.1 mL intramuscular injections (two in each corrugator and one in the procerus muscle) at each Treatment Visit. The total treatment dose (sum of the five injections) to be administered will be 30 U of Mentor Purified Toxin. Subjects will have many Treatment Visits throughout the course of the three-year study.
16285308|NCT00752245|Procedure|Dialysis during 4 hours|Blood and dialysate sampling
16285309|NCT00752245|Procedure|Dialysis during 6 hours|Blood and dialysate sampling
16285310|NCT00752245|Procedure|Dialysis during 8 hours|Blood and dialysate sampling
16285311|NCT00752232|Biological|ACC-001|IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
16285312|NCT00752232|Other|QS-21|IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
16285313|NCT00752232|Biological|ACC-001|IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
16285314|NCT00752232|Other|QS-21|IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
16285315|NCT00752232|Other|PBS|IM injection, Day 1, month 3, 6, 9, 12
16285316|NCT00752219|Drug|ceftazidime/NXL104 + metronidazole|IV TID
16285317|NCT00752219|Drug|meropenem|IV TID
16285318|NCT00752206|Drug|Saracatinib|Oral Agent
16285319|NCT00752206|Drug|Placebo|Oral Agent
16285320|NCT00752193|Other|Probiotic lactobacilli|Probiotic lactobacilli in combination with antibiotic therapy
16285321|NCT00752193|Other|Placebo|Placebo in combination with antibiotic therapy
16285322|NCT00752180|Biological|Wosulin R|Total dose per subject will be 0.3 IU/Kg given Subcutaneously.
16285323|NCT00752180|Biological|Actrapid|Total dose per subject will be 0.3 IU/kg given Subcutaneously.
16285447|NCT00751270|Biological|AdV-tk|Three different dosing levels of AdV-tk (3x10e10, 1x10e11, 3X10e11) were evaluated. A single injection of AdV-tk at the assigned dose level was administered, followed by 14 days of the oral prodrug valacyclovir. Patients then received standard of care radiation therapy and chemotherapy.
16285324|NCT00752154|Drug|Curcumin (Longvida™)|Curcumin (Longvida™) or matching placebo. They will begin by taking 4 capsules (approximately 2 grams) once a day for 2 weeks and then the dose will be increased to 4 capsules twice a day (4 gram per day) beginning at week 3. Subjects will remain at this dose for an additional 13 weeks for a total 16 weeks. After 16 weeks, the same procedures will be repeated for another 16 weeks
16285325|NCT00752141|Drug|oxybutynin chloride immediate-release|capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
16285326|NCT00752141|Drug|oxybutynin chloride topical gel|oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
16285327|NCT00752141|Other|placebo|capsule containing placebo tablet administered three times daily, and placebo gel administered once daily
16285328|NCT00752128|Device|Endeavor Resolute Zotarolimus-Eluting Coronary Stent System|Stent implantation
16285329|NCT00752115|Drug|sildenafil|50mg, day1,8 and 15 in each cycle
16285330|NCT00752115|Drug|placebo|1 tab, day 1,8 and 15 in each cycle.
16285331|NCT00752115|Drug|paclitaxel (taxol)|paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
16285332|NCT00752115|Drug|carboplatin (palaplatin)|carboplatin; AUC=6 on day 1, every 28 days
16285333|NCT00752102|Drug|Calcitriol (Rocaltrol®)|Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
16285334|NCT00752102|Drug|Paricalcitol|Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
16285335|NCT00752089|Drug|NaF/ KNO3/isopentane Dentifrice|Experimental toothpaste
16285336|NCT00752089|Drug|NaF/KNO3 Dentifrice|Experimental toothpaste
16285337|NCT00752089|Drug|NaF Dentifrice|Active comparator
16285338|NCT00752089|Other|Placebo Dentifrice|Placebo comparator
16285339|NCT00752076|Other|cancer cell lines establishment|Detection of epithelial growth factor receptor (EGFR) mutation in malignant pleural effusion of lung cancer patients and cancer cell lines establishment
16285340|NCT00752063|Drug|Sorafenib with Capecitabine and Oxaliplatin|Regimen 1: Oxaliplatin 85 mg/m2 (50 mg per vial) administered intravenously on day 1 of each cycle Regimen 2: Capecitabine 1700 mg/m2 p.o. (850 mg/m2 BD) day 1 to 7 Regimen 3: Sorafenib 400 mg (200 mg/tablet) orally BD day 1 to 14
16285341|NCT00752050|Drug|Mentor Purified Toxin Botulinum Toxin Type A|For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 30 U of the Active Comparator Mentor Purified Toxin.
16285342|NCT00752050|Drug|Preservative-free Saline|For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 0.5 mL of the placebo (preservative-free saline).
16285343|NCT00752037|Drug|lopinavir/ritonavir and raltegravir|lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
16285344|NCT00752024|Device|YL-1 type of intracranial hematoma puncture needle|"YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL：93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe.
~To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward."
16285345|NCT00752024|Drug|dehydrating agent, haemostatic|In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.
16285346|NCT00752011|Drug|TAS-106|Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
16285347|NCT00752011|Drug|Carboplatin|Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.
16285348|NCT00751998|Device|SpyGlass|The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
16285349|NCT00751985|Other|Personalised normative feedback (PNF)|"The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session.
~The brief personalised normative feedback will comprise the result of the participant's amount of alcohol consumption, previously given in an online questionnaire.
~Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. The feedback is also comparing their drinking, in graphical format, to the average drinking in the municipality concerned. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help."
16285350|NCT00751985|Other|Self-help material|"The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session.
~The intervention comprises of on-line self-help material informing about the participant's response from an online questionnaire shows that the participant's alcohol consumption exceeds the recommended limits.
~Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help."
16285351|NCT00751985|Other|Control|The participant is being informed about their allocation to the control group.
16285352|NCT00751972|Device|HeartWare® VAS|The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
16285353|NCT00751959|Drug|Curosurf|Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
16285354|NCT00751959|Drug|Curosurf|Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
16285602|NCT00750113|Drug|Nifedipine/Telmisartan|2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
16285355|NCT00751946|Behavioral|Trauma Adaptive Recovery Group Education and Therapy|"Trauma Affect Regulation: Guidelines for Education and Therapy (TARGET; Ford & Russo, 2006) is a manualized gender-specific treatment for PTSD. The 12-session individual therapy version in the present study is being adapted for adolescent girls based on a parallel version for young mothers and a group version that has been field tested with more than 20 adolescent girls.
~TARGET teaches a practical 7-step sequence of skills for processing and managing trauma-related reactions to current stressful experiences. The skills are designed in a sequence mirroring the three phases of complex traumatic stress disorder treatment (Ford, Courtois, Van der Hart, Nijenhuis & Steele, 2005), summarized by an acronym FREEDOM. TARGET also uses creative arts activities: personalized lifelines via collage, drawing, poetry, and writing."
16285356|NCT00751946|Behavioral|Enhanced Treatment As Usual|Enhanced Treatment as Usual (ETAU) is a 12-session supportive therapy adapted from the Present Centered Therapy co-developed by the first author (McDonagh-Coyle, Friedman, McHugo, Ford, Mueser, & Sengupta, 2005). In ETAU therapists invite the participant to talk about goals or problems that are important to her. The therapist's focus is on providing the core conditions of client centered psychotherapy (nonjudgmental acceptance, empathy, interpersonal warmth) and engaging the participant in a strengths-based solution-focused reflection on how she is successful (or has been in the past) in managing stressors, handling problems, achieving personal goals, and developing healthy relationships with peers, family, and other community members.
16285357|NCT00751933|Biological|Vaccine Vivotif + Vaccine Dukoral + oats|"Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
~One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
16285358|NCT00751933|Biological|Vaccine Vivotif + Vaccine Dukoral|Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
16285359|NCT00751933|Dietary Supplement|Oats|One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
16285360|NCT00751933|Other|Placebo|Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
16285361|NCT00751920|Procedure|Enhanced MRI Scan|Following the detection of a pulmonary nodule(s) with the unenhanced MRI scan, the subjects will then be injected with the contrast agent, Magnevist, and have a dynamic enhanced MRI scan of the largest pulmonary nodule.
16285362|NCT00751907|Drug|atorvastatin|40mg daily for 4 months
16285363|NCT00751907|Drug|Placebo|Matching placebo daily for 4 months
16285364|NCT00751894|Drug|Pegfilgrastim (Neulasta, Amgen)|sequential Bayesian study
16285365|NCT00751881|Drug|Placebo|"Film-coated tablet
~Oral administration"
16285366|NCT00751881|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16285367|NCT00751868|Drug|Ixabepilone|Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)
16285368|NCT00751855|Behavioral|Prolonged Exposure therapy|10 weekly sessions
16285369|NCT00751855|Drug|Hydrocortisone|30mg 45 minutes prior to each PE session including imaginal exposure (8 total)
16285370|NCT00751855|Drug|placebo|placebo
16285371|NCT00751842|Drug|rhGAD65|Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
16285372|NCT00751842|Drug|rhGAD65|Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
16285373|NCT00751842|Drug|Placebo|Placebo injected subcutaneously at days 1, 30, 90 and 270.
16285374|NCT00751829|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary|oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
16285375|NCT00751829|Drug|nitrendipine + hydrochlorothiazide, if necessary|oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
16285376|NCT00751816|Drug|systemic chemotherapy|
16285377|NCT00751816|Other|survey administration|will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.
16285378|NCT00751816|Procedure|adjuvant therapy|
16285379|NCT00751816|Procedure|management of therapy complications|
16285380|NCT00751816|Procedure|musculoskeletal complications management/prevention|
16285381|NCT00751816|Procedure|physical therapy|weekly visits coordinated with adjuvant treatment as part of standard care
16285382|NCT00751816|Radiation|radiation therapy|
16285383|NCT00751803|Drug|BI 44370 TA Low Dose|
16285384|NCT00751803|Drug|Eletriptan|
16285385|NCT00751803|Drug|Placebo|
16285386|NCT00751803|Drug|BI 44370 TA Medium Dose|
16285387|NCT00751790|Drug|triptorelin embonate (INN)|Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
16285388|NCT00751777|Biological|heat-labile enterotoxin of E. coli (LT)|Travelers' Diarrhea Vaccine System
16285389|NCT00751777|Biological|Placebo|Travelers' Diarrhea Vaccine System
16285390|NCT00751764|Drug|Moxidectin|
16285391|NCT00751751|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary|oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
16285392|NCT00751751|Drug|losartan + hydrochlorothiazide, if necessary|oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.
16285393|NCT00751738|Drug|azimilide dihydrochloride|oral, once daily until sponsor stopped the study
16285448|NCT00751270|Drug|Valacyclovir|The oral prodrug valacyclovir was given beginning 1-3 days following the AdV-tk. Valacyclovir tablets were taken three times a day for a total of 14 days.
16285449|NCT00751257|Drug|N-acetylcysteine|2400mg (1200mg b.i.d., 600mg capsules, p.o.)
16285450|NCT00751257|Drug|Placebo|"Identically appearing placebo capsules, packaged in an N-acetylcysteine slurry so that placebo has similar odor as active NAC capsules"
16285603|NCT00750100|Drug|human chorionic gonadotropin|hCG 200IU in the late follicular phase
16285394|NCT00751712|Device|Cerebral oximeter sensor|The INVOS Cerebral Oximeter utilizes two electrodes to monitor cerebral oxygenation. The recommended placement of these electrodes is on the forehead to monitor the frontal cortex. In this study, one electrode will be placed in the normal position on the forehead, and the other will be placed at the base of the skull. The stickers will be placed on the patient at the beginning of surgery and removed at the end. The maximum amount of time that they will be on the patient's skin is approximately six hours. Application of the stickers and the data they provide will not alter the provider's treatment plan. This procedure will be used for all enrolled patients, whether they are enrolled in Part I or Part II.
16285395|NCT00751699|Drug|Asacol|Asacol tablets, 6 tablets per day at 7 am for 7 days
16285396|NCT00751699|Drug|Asacol|Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days
16285397|NCT00751699|Drug|Lialda|Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days
16285398|NCT00751686|Procedure|Stool sample|Collection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms.
16285399|NCT00751686|Other|Data collection|Logbook, Health Economic Questionnaire, Telephone call.
16285400|NCT00751660|Other|laboratory biomarker analysis|
16285401|NCT00751660|Other|screening questionnaire administration|
16285402|NCT00751660|Procedure|bronchoscopic and lung imaging studies|
16285403|NCT00751660|Procedure|computed tomography|
16285404|NCT00751660|Procedure|endoscopic biopsy|
16285405|NCT00751660|Procedure|quality-of-life assessment|
16285406|NCT00751647|Other|Physical Therapy|Treatment
16285407|NCT00751634|Device|Gaymar Rapr-Round (external cooling blanket)|Application of the device per its approved labeling
16285408|NCT00751621|Biological|IgPro20|
16285409|NCT00751608|Drug|APL180|
16285410|NCT00751608|Drug|APL180|
16285411|NCT00751608|Drug|Placebo|
16285412|NCT00751595|Biological|Tat protein|Biologically active recombinant Tat protein
16285413|NCT00751582|Dietary Supplement|Food supplementation and nutrition education|Food supplementation and nutrition education for three months
16285414|NCT00751582|Behavioral|Nutrition education|Nutrition education for children for three months
16285415|NCT00751582|Other|Control Group|No Nutrition Education
16285416|NCT00751569|Other|blood donation|obtaining cord blood
16285417|NCT00751556|Drug|Naproxen Sodium 660mg|Extended release Naproxen Sodium (660mg) administered once a day
16285418|NCT00751556|Drug|Commercial Aleve 220 mg|Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total
16285419|NCT00751543|Radiation|CT, radiation therapy|Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed evaluation of tissue and organ perfusion with excellent resolution
16285420|NCT00751530|Drug|raltegravir|New combination ART incorporating raltegravir with other ARVs.
16285421|NCT00751517|Drug|Methotrexate|
16285422|NCT00751517|Drug|Cyclophosphamide|
16285423|NCT00751504|Drug|Quetiapine|Dosage form: tablets Dosage: between 300 mg/die and 600 mg/die Frequency: once daily Duration: 6 weeks
16285424|NCT00751491|Drug|Adenosin|Intracoronary Adenosin 50 microg;
16285425|NCT00751491|Other|placebo|no intervention
16285426|NCT00751491|Drug|Clopidogrel|Clopidogrel 300/600 mg
16285427|NCT00751478|Drug|ALO-01|ALO-01 capsules
16285428|NCT00751478|Drug|MSIR|immediate release morphine sulfate
16285429|NCT00751478|Drug|Placebo|Placebo
16285430|NCT00751465|Behavioral|Task Concentration Training|Task Concentration Training TCT following Bögels et al. (1997).
16285431|NCT00751465|Behavioral|Standard CBT|Standard CBT following the Clark-and-Wells (1995) model of social anxiety disorder, relying on the German manual for SAD (stangier et al., 2006). Includes the model, role-plays with and without safetey behavior, video-feedback.
16285432|NCT00751413|Drug|Comparator: MK0633|A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
16285433|NCT00751400|Drug|Naproxen Sodium ER (BAYH6689)|Consumer use of Extended Release Naproxen Sodium
16285434|NCT00751374|Drug|gentamicin|topical gentamicin cream on daily basis
16285435|NCT00751374|Drug|gentamicin cream alternating with mupirocin cream|topical gentamicin cream alternating with mupirocin cream at monthly basis
16285436|NCT00751361|Device|Rheopheresis / double filtration plasmapheresis|Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
16285437|NCT00751348|Biological|PriorixTM|Subcutaneous administration in left upper arm
16285438|NCT00751348|Biological|VarilrixTM|Subcutaneous administration in right upper arm
16285439|NCT00751348|Biological|Priorix-Tetra®|Subcutaneous injection in left upper arm
16285440|NCT00751335|Device|CPAP with ThermoSmart, then CPAP without ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.
~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
16285441|NCT00751335|Device|CPAP without ThermoSmart, then CPAP with ThermoSmart|"CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.
~CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube."
16285442|NCT00751322|Other|RBC transfusion of 5 days or less storage age|RBC transfusion of 5 days or less storage age
16285443|NCT00751322|Other|RBC transfusion of conventional storage age|RBC transfusion of conventional storage age
16285444|NCT00751309|Other|Non-interventional|Post-transplantation observational study
16285445|NCT00751296|Drug|Lenalidomide|Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle.Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
16285446|NCT00751283|Device|GRST Peripheral Catheter System|Treatment to dilate stenoses and reduce plaque in treated vessels
16285516|NCT00750789|Dietary Supplement|dates|5 maedjool dates or 7 emery dates per day for 2 weeks each with a washout period of 2 weeks between
16285451|NCT00751244|Behavioral|Trauma Affect Regulation: Guide for Education and Therapy|"Trauma Affect Regulation: Guide for Education and Therapy (TARGET; Ford & Russo, 2006) is a manualized gender-specific treatment for PTSD. TARGET teaches a practical 7-step sequence of skills for processing and managing trauma-related reactions to current stressful experiences, summarized by a mnemonic (FREEDOM), e.g., Focusing (F), Recognizing current triggers. TARGET also involves creative arts activities, i.e., personalized lifelines via collage, drawing, poetry, and writing that may include traumatic experiences but emphasize life story narrative reconstruction with no exposure therapy."
16285452|NCT00751244|Behavioral|Present Centered Therapy (PCT) - psychotherapy|"Present Centered Therapy (PCT) is a 12-session supportive therapy adapted a 14-session version co-developed by the first author (McDonagh-Coyle et al., 2005). Psychoeducation is provided about the link between traumatic events, PTSD symptoms, and problems in relationships, and social problem solving skills are taught to address the traumagenic dynamics of betrayal, stigma, powerlessness, and sexualization (Finkelhor, 1987). PCT focuses on addressing current problems rather than trauma memory-based exposure therapy, and uses a distinctive mnemonic to organize the skill set. PCT has clients keep a journal of relational stressors and responses as between-session homework."
16285453|NCT00751244|Other|"No-treatment waitlist group"|After a 90 day wait-list period, participants were invited to choose one of the treatment approaches (PCT or TARGET) and engage in 12 sessions of therapy.
16285454|NCT00751231|Drug|clopidogrel|Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg
16285455|NCT00751231|Drug|PRT060128|80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg
16285456|NCT00751218|Drug|desloratadine|desloratadine, 5mg oral tablets, once daily for 28 days
16285457|NCT00751218|Drug|placebo|placebo, once daily for 28 days
16285458|NCT00751218|Drug|cetirizine|cetirizine, 10 mg capsules once daily for 28 days
16285459|NCT00751205|Drug|Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid|Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. In addition, subjects will receive Acetyl-L-Carnitine (ALC) 1000 mg tid. Treatment with Sagopilone and ALC will be continued as long as there is benefit. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.
16285460|NCT00751205|Drug|Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid|Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment will be continued as long as there is benefit. In addition, subjects will receive 21 weeks of placebo 1000 mg tid. After all patients have completed 6 cycles of treatment, an analysis will be performed to see whether ALC was better than placebo. If this is the case, patients still under placebo treatment will be offered to switch to ALC. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.
16285461|NCT00751192|Device|HIV-testing motivational videos|
16285462|NCT00751192|Device|Standard public health text|
16285463|NCT00751179|Drug|rocuronium|A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.
16285464|NCT00751179|Drug|sugammadex|At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.
16285465|NCT00751179|Drug|succinylcholine|A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.
16285466|NCT00751166|Drug|Desloratadine|Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
16285467|NCT00751166|Drug|Cetirizine|Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
16285468|NCT00751166|Drug|placebo|placebo once daily for 28 days
16285469|NCT00751153|Drug|Raltegravir and Atazanavir|Rategravir 400 BID, Atazanavir 400 mg daily
16285470|NCT00751140|Procedure|Lymph Node Dissection|The lymph nodes will be sent to pathology for review.
16285471|NCT00751127|Drug|PhXA41|One drop in the affected eye once daily for six months.
16285472|NCT00751127|Drug|timolol|One drop in the affected eye twice daily for six months.
16285473|NCT00751114|Drug|Insulin Glargine|Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).
16285474|NCT00751114|Drug|Sitagliptin|Oral administration. 100 mg film-coated tablets.
16285475|NCT00751114|Drug|Metformin|Patients continued with metformin as usual oral anti-diabetic treatment.
16285476|NCT00751101|Drug|Nicotine patch|Nicotine patch applied prior to and concurrently with capecitabine chemotherapy or beginning during the first course of capecitabine after the onset of hand-foot syndrome symptoms
16285477|NCT00751088|Procedure|MiniArc positioning|"Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. MiniArc will be placed by means of curved single use needle. Incision closure."
16285478|NCT00751088|Procedure|TVT secur system positioning|"Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. TVT Secur System will be placed by means of two curved, stainless steel, single use introducers. Incision closure."
16285517|NCT00750763|Drug|Colonlytely|Bowel preparation
16285518|NCT00750763|Drug|Picolax/Picoprep|Bowel preparation
16285519|NCT00750763|Drug|Fleet|Bowel preparation
16285604|NCT00750100|Drug|recombinant gonadotropins|200 IU per day during controlled ovarian stimulation
16286381|NCT00743678|Drug|FOLFOX6/cetuximab|Neoadjuvant FOLFOX6/cetuximab
16285479|NCT00751088|Procedure|Ajust positioning|"Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. Ajust will be placed by means of a safe hook geometry introducer. Incision closure."
16285480|NCT00751088|Procedure|Tension free vaginal ttape|Patient placed in lithotomic position. 15 mm vaginal incision below urethral meatus. Dissection of the paraurethral space on each side of the incision and of the bladder from the inferior edge of the pubis. Transversal 10 mm skin incisions at level of superior pubic margin. Top-down or bottom-up approach passage of the needles and sling. Adjustment of sling tension. Closure of vaginal and skin incisions.
16285481|NCT00751075|Drug|mometasone furoate nasal spray (MFNS)|Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period
16285482|NCT00751075|Drug|MFNS|Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period
16285483|NCT00751075|Drug|Amoxicillin|Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period
16285484|NCT00751075|Drug|Placebo|Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation
16285485|NCT00751062|Drug|timolol|One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
16285486|NCT00751062|Drug|PhXA41|One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
16285487|NCT00751049|Drug|timolol|One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
16285488|NCT00751049|Drug|PhXA41|One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
16285489|NCT00751036|Drug|Nilotinib|Nilotinib hard gel capsules were supplied to the Investigators at dose strengths of 200 mg. Nilotinib is a novel agent, which has been approved for the treatment of chronic phase and accelerated phase Philadelphia-chromosome-positive CML in adult patients resistant to or intolerant to prior therapy that included imatinib.
16285490|NCT00751036|Drug|Imatinib|Imatinib tablets were supplied at 100 mg and/or 400 mg dose strength. Imatinib is an approved agent for GIST. Efficacy of imatinib at a dose of 400 mg bid has been established in the setting of disease progression after the use of the conventional dose (400 mg qd).
16285491|NCT00751023|Drug|Modafinil|400 mg daily for four weeks
16285492|NCT00751023|Drug|Placebo|Placebo 2 tablets daily for 4 weeks
16285493|NCT00750997|Drug|hypertonic saline|patients in parent trial were randomized to 250cc 7.5% saline, 7.5%saline with 6%dextran or normal saline as control as the initial resuscitation fluid after injury with signs of either hemorrhagic shock or severe traumatic brain injury
16285494|NCT00750984|Procedure|Anterolateral approach|The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.
16285495|NCT00750984|Procedure|Posterior approach|The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.
16285496|NCT00750984|Device|ReCap Total Hip Resurfacing|This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
16285497|NCT00750984|Device|ReCap Total Hip Resurfacing|This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
16285498|NCT00750971|Procedure|Immunoablation and Autologous Hematopoietic Stem Cell Transplantation|Transplantation of purified CD34+ autologous hematopoietic stem cells mobilized with cyclophosphamide (200mg/m2)and G-CSF (10µg/kg/d) after immunoablation with cyclophosphamide (200mg/kg)and rabbit-antithymocyteglobulin (90mg/kg)
16285499|NCT00750958|Procedure|NetGuard Automated Clinician Alert System|Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.
16285500|NCT00750945|Other|Music and treadmill walking program|Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
16285501|NCT00750945|Other|Treadmill walking program|Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
16285502|NCT00750945|Other|Home program|Home walking program 6 days/wk x 4 weeks
16285503|NCT00750919|Drug|esmirtazapine|
16285504|NCT00750893|Biological|Rotarix or Rotarix liquid formulation|GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).
16285505|NCT00750880|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv (60 minute infusion)
16285506|NCT00750867|Drug|intravenous immunoglobulin (IVIg)|The intravenous immunoglobulin (brand Privigen) will be infused intravenously, monthly, 6 times, for 6 months the dose will be 0.4 gram/kg for each infusion.
16285507|NCT00750854|Dietary Supplement|NEM Formulation X|see Treatment Arms
16285508|NCT00750854|Dietary Supplement|NEM Formulation Y|see Treatment Arms
16285509|NCT00750841|Drug|cediranib|45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce.
16285510|NCT00750815|Drug|Cyclophosphamide|Enroll patients into 4 different dose levels. The dose of Cyclophosphamide they receive will depend on how many patients have been treated.
16285511|NCT00750815|Drug|Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD)|Patients will receive Bortezomib, Pegylated Liposomal Doxorubicin and Dexamethasone at standard doses.
16285512|NCT00750802|Drug|AZD6280|10mg Capsule, oral, single-dose
16285513|NCT00750802|Drug|AZD6280|40mg Capsule, oral, single-dose
16285514|NCT00750802|Drug|Lorazepam|2mg tablet, oral single-dose
16285515|NCT00750802|Drug|Placebo|
16285601|NCT00750113|Drug|Telmisartan|Tablets 80 Mg daily for 4 weeks then combination therapy
16285520|NCT00750750|Drug|mometasone furoate nasal spray (MFNS)|Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period
16285521|NCT00750750|Drug|MFNS|Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period
16285522|NCT00750750|Drug|Amoxicillin|Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period
16285523|NCT00750750|Drug|Placebo|Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation
16285524|NCT00750737|Drug|Posaconazole|200 mg three times daily by mouth up to 6 weeks (Days 1-42)
16285525|NCT00750737|Drug|ABLC|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
16285526|NCT00750724|Drug|"25 mg sodium hyaluronate GO ON"|25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks
16285527|NCT00750724|Drug|normal saline,2 ml., intraarticular weekly for 5 weeks|
16285528|NCT00750711|Procedure|Radiofrequency ablation for atrial flutter by catheters|
16285529|NCT00750698|Drug|SNDX-275|SNDX-275 (10 mg fixed dose PO Q2W) on days 1 and 15 of a 28-day cycle for up to 6 cycles
16285530|NCT00750698|Drug|erlotinib|erlotinib (150 mg PO QD) for up to six (6) 28-day cycles
16285531|NCT00750685|Device|Mentor Smooth Becker 50 Expander/Breast Implant|The Mentor Becker Expander/Breast Implant is comprised of two components: the Becker implant and the injection dome/fill tube. The breast implant is available in a smooth surface. It has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The silicone elastomer fill tube is pre-inserted into the dual self-sealing valve system at the time of manufacture and is joined to the injection dome by the connector system at the time of surgery. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
16285532|NCT00750659|Drug|Nilotinib|Nilotinib 400 mg po/BID until transplant. Nilotinib 200-400 mg po/BID post transplant in escalated doses.
16285533|NCT00750646|Device|MEMS cap|The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.
16285534|NCT00750633|Drug|Moxidex otic solution|4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
16285535|NCT00750633|Drug|Moxifloxacin otic solution|4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
16285536|NCT00750633|Drug|Dexamethasone phosphate otic solution|4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
16285537|NCT00750633|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children
16285538|NCT00750620|Drug|YM178|oral
16285539|NCT00750581|Drug|Indomethacin|Infants randomized to Escalating Dose group will receive indomethacin (0.2 mg/kg/dose) at 12 hr intervals for 2 doses, followed by indomethacin (0.3 mg/kg/dose) at 12 hr interval for 2 doses, then Indomethacin (0.4 mg/kg/dose) at 12 hr interval for 2 doses, increased to indomethacin (0.5 mg/kg/dose) at 12 hour interval for 2 doses and finally indomethacin 0.6 mg/kg/dose at 12 hourly interval for 2 doses.
16285540|NCT00750555|Drug|Erlotinib|150 mg per day orally until disease progression occurs, up to a maximum of 12 months
16285541|NCT00750529|Drug|Galantamine and Donepezil|the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication
16285542|NCT00750503|Behavioral|Behavioural and Pharmacotherapy for tobacco cessation|Professional help in the form of health awareness sessions, focus group discussion, one to one counseling and pharmacotherapy was provided to the employees by a team of doctors and counselors from Tata Memorial Hospital. Self reporting of tobacco history was validated with Rapid Urine cotinine test. Naked eye examination of oral cavity of all employees for detection of oral pre-cancers and cancers was conducted. Nursing staff and Doctors attached to the industry and from the local referral hospital were invited to participate as trainees during the active intervention sessions for local manpower development.
16285543|NCT00750477|Dietary Supplement|NEM|see Treatment Arms
16285544|NCT00750477|Dietary Supplement|Placebo|Placebo comparator containing inactives
16285545|NCT00750451|Drug|low molecular weight heparin (enoxaparine sodium)|1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
16285546|NCT00750451|Drug|crinone 8% gel|routine luteal phase support with progesterone gel
16285547|NCT00750438|Dietary Supplement|Propionate ester|The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
16285548|NCT00750438|Dietary Supplement|Inulin|The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
16285549|NCT00750438|Dietary Supplement|Cellulose|The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
16285550|NCT00750425|Drug|cediranib (RECENTIN TM, AZD2171)|20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days)
16285551|NCT00750412|Behavioral|TeenScreen Program|Adolescents who are randomized into the TeenScreen program and their parent/guardian will receive post-screening information, a facilitated referral, and case management services from a research social worker.
16285552|NCT00750399|Drug|Ranibizumab|intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.
16285553|NCT00750399|Drug|ranibizumab|intravitreal ranibizumab 0.5 mg
16285554|NCT00750386|Drug|Paclitaxel|175 mg/m2, I.V, every 2 weeks
16285555|NCT00750386|Drug|Carboplatin|Carboplatin AUC, I.V, 5 every 2 weeks
16285556|NCT00750373|Procedure|Valve surgery with removal of vegetations|Early valve repair or replacement with removal of vegetations within 48 hours of randomization
16285644|NCT00749736|Dietary Supplement|doxercalciferol|1 mcg of doxercalciferol per day
16285557|NCT00750360|Biological|FluarixTM|All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
16285558|NCT00750347|Drug|Rimonabant and Paracetamol and placebo|evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers
16285559|NCT00750334|Drug|clofarabine|Drug given Daily x 14 days and 7 days of rest for 21 day cycle
16285560|NCT00750334|Drug|clofarabine|Drug given Daily X 14 days and 7 days of rest for 21 day cycle
16285561|NCT00750308|Drug|Ramipril|Ramipril 10 mg per day for three weeks
16285562|NCT00750308|Drug|Tadalafil|tadalafil 10 mg every other day for three weeks
16285563|NCT00750308|Drug|placebo|placebo matching ramipril
16285564|NCT00750308|Drug|placebo|placebo matching tadalafil
16285565|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285566|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285567|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285568|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285569|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285570|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285571|NCT00750295|Drug|SBR759|Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
16285572|NCT00750282|Drug|Florbetaben (BAY94-9172)|Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
16285573|NCT00750269|Radiation|SBRT 40.0 Gy|SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy
16285574|NCT00750269|Radiation|SBRT 42.5 Gy|SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy
16285575|NCT00750269|Radiation|SBRT 45.0 Gy|SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy
16285576|NCT00750269|Radiation|SBRT 47.5 Gy|SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy
16285577|NCT00750269|Radiation|SBRT 50.0 Gy|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
16285578|NCT00750269|Radiation|SBRT 52.5 Gy|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
16285579|NCT00750269|Radiation|SBRT 55.0 Gy|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
16285580|NCT00750269|Radiation|SBRT 57.5 Gy|SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
16285581|NCT00750269|Radiation|SBRT 60.0 Gy|SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
16285582|NCT00750256|Drug|GSK1278863A|GSK1278863A planned doses from 2mg to 450mg which may change based on safety or PK from previous cohorts.
16285583|NCT00750243|Drug|LT-NS001|1200 mg b.i.d. p.o. for 7.5 days
16285584|NCT00750243|Drug|Naprosyn®|500 mg b.i.d. p.o. for 7.5 days
16285585|NCT00750230|Dietary Supplement|NEM|see Treatment Arm
16285586|NCT00750217|Drug|Buprenorphine patch and sublingual tablets|"Buprenorphine patch: 35 micro grams per hour 12 to 48 hours after last methadone intake.
~Buprenorphine sublingual tablets: 2mg 48 and 60 hours after last methadone intake; 8mg 72 and 84 hours after last methadone intake; 8mg 96, 102 and 109 hours after last methadone intake."
16285587|NCT00750204|Device|APRV|"APRV Protocol
~Set fraction of inspired oxygen (FiO2) at 0.1 higher than the setting on conventional MV currently used
~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).
~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.
~P high = the inspiratory plateau pressure. Maximum P high = 30 cm H20.
~Plow = 5 cm water (H2O). Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of percent body weight (PBW).
~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease P high in increments of 2-4 cm H20 to achieve desired release volumes (minimum P high = 12 cm H20). If release volumes on APRV still remain larger than desired,the participant will be excluded from the study and placed on conventional MV."
16285588|NCT00750204|Device|Conventional MV|Low tidal-volume mechanical ventilation
16285589|NCT00750191|Device|The Transdiscal Radiofrequency Annuloplasty|Adjustment in dosage form, frequency and or duration.
16285590|NCT00750191|Device|The Transdiscal Radiofrequency Annuloplasty|interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
16285591|NCT00750178|Drug|vorinostat (MK0683 )|"Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28
~Total treatment period is 28 days"
16285592|NCT00750165|Device|SleepStyle 200 Auto Series CPAP Humidifier|The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
16285593|NCT00750152|Drug|NAFT-500|topical cream application up to 4 weeks
16285594|NCT00750152|Drug|Placebo|placebo cream applied for up to 4 weeks
16285595|NCT00750139|Drug|NAFT-500|topical cream 1 application every day up to 4 weeks weeks
16285596|NCT00750139|Drug|Placebo 2-weeks|placebo cream 1 application every day for up to 4 weeks
16285597|NCT00750139|Drug|Naftin 1%|topical allylamine cream applied once a day for up to 4 weeks
16285598|NCT00750139|Drug|Placebo 4-weeks|topical placebo cream applied once a day for up to 4 weeks
16285599|NCT00750126|Drug|Fludarabine, Busulfan, Thymoglobulin|"study :
~acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation
~the effectiveness of the protocol on tumor response
~overall survival"
16285600|NCT00750113|Drug|Nifidipine|Tablets 20 Mg daily for 4 weeks then combination therapy
16285605|NCT00750061|Drug|Lithium Carbonate|"The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
~The course of medication is 6 weeks."
16285606|NCT00750061|Drug|Placebo|Matching placebo
16285607|NCT00750048|Drug|Naloxone and paracetamol|to check if naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials
16285608|NCT00750035|Procedure|Total abdominal hysterectomy|Total abdominal hysterectomy and Subtotal abdominal hysterectomy
16285609|NCT00750035|Procedure|Subtotal abdominal hysterectomy|
16285610|NCT00750022|Behavioral|Individualized IC treatment|Individuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle.
16285611|NCT00750022|Behavioral|Usual Care|Individuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior.
16285612|NCT00750009|Other|educational intervention|Patients receive a tailored intervention or generic information
16285613|NCT00749996|Device|DIAM™ Spinal Stabilization System|The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
16285614|NCT00749996|Procedure|Herniectomy|"Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
16285615|NCT00749983|Dietary Supplement|Creatine supplementation|
16285616|NCT00749983|Dietary Supplement|Dextrose supplementation|
16285617|NCT00749957|Biological|rAAV2-CB-hRPE65|Recombinant adeno-associated virus vector expressing RPE65
16285618|NCT00749944|Drug|varenicline|1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
16285619|NCT00749944|Drug|placebo|1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
16285620|NCT00749931|Device|MarginProbe|Device use to assess margin status of the excised specimen surface.
16285621|NCT00749931|Procedure|Lumpectomy|Standard of care lumpectomy procedure
16285622|NCT00749918|Dietary Supplement|Cholecalciferol (vitamin D3)|Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.
16285623|NCT00749905|Other|low fiber diet|Low fiber diet for 5 days prior to colon capsule
16285624|NCT00749905|Other|regular diet|Regular diet until 1 day before colon capsule
16285625|NCT00749892|Drug|Erlotinib Hydrochloride|Given PO
16285626|NCT00749879|Drug|Proellex|25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
16285627|NCT00749866|Drug|Gentamicin|Nebulised 80mg twice daily
16285628|NCT00749866|Drug|Saline|Nebulised 4mls 0.9% Saline twice daily
16285629|NCT00749853|Drug|follicle stimulating hormone|Pituitary down-regulation will be achieved using buserelin (Suprefact®, Hoechst, Frankfurt, Germany) at a fixed daily dose of 200 mg s.c., according to a long agonist protocol, starting on day 2 of the normal menstrual cycle. Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations <200 pmol/l and no follicles >15 mm in diameter or ovarian cysts on ultrasonographic examination. The initial r-hFSH dose will be 250 IU s.c. daily for 5 days, after which the dose will be increased to a maximum of 450 IU per day using a step-up protocol with steps of 50 IU/day.
16285630|NCT00749853|Drug|follicle stimulating hormone|No pituitary down-regulation will be performed. Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations <200 pmol/l and no follicles >15 mm in diameter or ovarian cysts on ultrasonographic examination. The r-hFSH dose will be 150 IU s.c. daily for 11 consecutive days.
16285631|NCT00749840|Behavioral|Questionnaire|Questionnaire taking 60-90 minutes.
16285632|NCT00749827|Drug|Bicarbonate Hydration|"Intravenous sodium bicarbonate (130 mEq/L) in 4.35% dextrose at 3.5 ml/Kg over 1 hour pre-contrast, followed by the same solution intravenously at 1 ml/Kg/hr for 6 hours. In all cases the maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular low-osmolal or iso-osmolal contrast (according to operator or institution choice) will be used in the minimal dose needed to complete the required imaging.
~Hypotonic hydration arm. Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours."
16285633|NCT00749827|Drug|Hypotonic hydration|Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.
16285634|NCT00749814|Dietary Supplement|Melatonin|Melatonin slow release tablets, 2 mg, 1 hour before bedtime for 7 days prior to admission to the hospital and up to 7 days after surgery.
16285635|NCT00749814|Other|Placebo tablets|Placebo
16285636|NCT00749801|Drug|Nattokinase|2 capsules in the morning and before bed-time daily
16285637|NCT00749788|Drug|JTT-302|JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
16285638|NCT00749788|Drug|JTT-302|JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
16285639|NCT00749788|Drug|Placebo|Matching placebo tablets, oral, 30 minutes after the start of the morning meal
16285640|NCT00749775|Drug|Selara|Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Selara may be administered with or without food.
16285641|NCT00749749|Drug|Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)|The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
16285642|NCT00749749|Drug|ON-Q PainBuster Post-op Pain relief System|5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])
16285643|NCT00749736|Dietary Supplement|cholecalciferol|"4000 IU of cholecalciferol per day
~15 patients will be enrolled in each arm."
16285645|NCT00749736|Dietary Supplement|placebo|"placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula.
~15 patients will be enrolled in each arm."
16285646|NCT00749723|Drug|carboplatin|200 mg/m²/d continuously IV on day 1-4 of each 21-28-day-cycle. Number of cycles: until disease progression, maximum 4 cycles
16285647|NCT00749723|Drug|etoposide|100mg/m²/d continuously IV on day 1-4 of each 21-28 day cycle. Number of cycles: until disease progression, maximum 4 cycles
16285648|NCT00749723|Drug|temozolomide|150mg/m²/d p.o. on day 1-5 of a 21-28-day-cycle. Number of cycles: until progression or maximum up to 2 years
16285649|NCT00749723|Drug|thiotepa, carboplatin, etoposide|high dose chemotherapy followed by to autologous stem cell transplantation
16285650|NCT00749723|Drug|temozolomide, thiotepa|high dose chemotherapy followed by autologous stem cell transplantation
16285651|NCT00749723|Procedure|autologous stem cell transplantation|autologous stem cell transplantation following HD-chemotherapy
16285652|NCT00749723|Drug|intraventricular etoposide|prior to systemic chemotherapy as single agent in patients with neoplastic meningitis, in addition to systemic chemotherapy if proven effective in phase II study, intraventricularly age-dependent daily dose (>3m to <3y 0.7 mg; >3y 1.0 mg) for 5 days every 2 two 4 weeks. Number of cycles: at least 3 courses, maximum up to 2 years
16285653|NCT00749723|Drug|trofosfamide, etoposide|maintenance therapy: trofosfamide and etoposide: 100 mg/m²/d and 25 mg/m²/d, respectively, for 21 days every 4 weeks. Number of cycles: until progression or maximum up to 2 years
16285654|NCT00749710|Procedure|clopidogrel|ORIF - surgical treatment
16285655|NCT00749710|Procedure|no antiaggregant therapy|ORIF - surgical treatment
16285656|NCT00749697|Other|SPECT scan|SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose
16285657|NCT00749684|Biological|Interferon α-2b|20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.
16285658|NCT00749671|Device|Bispectral index monitoring|The monitoring of the EEG signal is designed to determine if the sedation is adequate.
16285659|NCT00749671|Other|Ramsey Sedation Scale|The determination of the degree of sedation is accomplished using an established sedation scale.
16285660|NCT00749658|Drug|Bupropion|Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
16285661|NCT00749658|Drug|Varenicline|Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
16285662|NCT00749645|Drug|FANG(30)|Andrographolide formula Oral tablets, 30mg, three times per day, during a total of 105 continuous days.
16285663|NCT00749645|Drug|Placebo|Placebo 30mg tabs, 3/day, 105 days continuously.
16285664|NCT00749632|Drug|oxybutynin|low dose oxybutynin administered daily
16285665|NCT00749632|Drug|oxybutynin|middle dose oxybutynin administered daily
16285666|NCT00749632|Drug|oxybutynin|high dose oxybutynin administered daily
16285667|NCT00749619|Other|Catheter Lock Solution Taurolidine and Citrate|
16285668|NCT00749619|Other|Catheter Lock Solution :Taurolidine and Citrate and Heparin|
16285669|NCT00749619|Other|Catheter Lock Solution : Heparin|
16285670|NCT00749606|Behavioral|Individual telephone intervention|"Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
16285671|NCT00749606|Behavioral|Group telephone intervention|"Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
16285672|NCT00749580|Drug|Switch NRTIs as a Backbone to Raltegravir|This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA <75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.
16285673|NCT00749567|Drug|Erlotinib|Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
16285674|NCT00749567|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity
16285675|NCT00749554|Device|Disc biacuplasty|The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C).
16285676|NCT00749554|Device|Sham biacuplasty|Probes not inserted into disc, no RF electricity applied.
16285677|NCT00749515|Drug|Deferoxamine|After a 3-day washout period from all chelation, all patients have a 12 hour infusion of 50mg/kg of deferoxamine with urine collection and pre and post blood sampling to assess iron and Total Iron Binding Capacity (TIBC) by atomic absorption.
16285678|NCT00749515|Drug|Deferasirox|After a 3-day washout period from all chelation, patients had a desferal challenge which was followed by a single dose of deferasirox, 35mg/kg orally with blood sampling taken pre-deferasirox and at intervals for 24 hours after the dose.
16285679|NCT00749515|Radiation|HIDA|All patients had a HIDA scan to assess physiologic liver clearance capacity.
16285680|NCT00749502|Drug|MK-4827|MK-4827 in 10 mg and 100 mg capsules given daily in a 21 day dosing cycle (dose escalation to RP2D).
16285726|NCT00749086|Procedure|vertebroplasty|Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance
16285681|NCT00749489|Procedure|Femoral Nerve Block|Patients assigned to the intervention group will have a femoral nerve block administered by the attending emergency department physician. Twenty-four hours after the femoral nerve block or at the time of surgery, an anesthesiologist will insert a continuous fascia iliaca block. Both procedures (femoral nerve block and fascia iliaca blocks) are standard anesthetic techniques that are used in orthopedic procedures but their efficacy as compared to standard opioid therapy has not been evaluated in controlled clinical trials in hip fracture. The medications that will be used in each procedure are as follows: 1) femoral nerve block: 0.5% bupivacaine with 1:300,000 epinephrine; 2) fascia iliaca block: 0.2% ropivacaine will be infused at 5ml/hr.
16285682|NCT00749476|Biological|Factor IX recovery|
16285683|NCT00749463|Drug|Nicotine Gum|2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
16285684|NCT00749463|Drug|Nicotine Patch|Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
16285685|NCT00749450|Drug|capecitabine|Given orally
16285686|NCT00749450|Drug|fluorouracil|Given IV
16285687|NCT00749450|Drug|oxaliplatin|Given IV
16285688|NCT00749437|Radiation|3-dimensional conformal accelerated partial breast irradiation|Accelerated partial breast irradiation following lumpectomy with placement of Acculoc fiducial markers.
16285689|NCT00749424|Device|SES|CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
16285690|NCT00749424|Device|SES|CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
16285691|NCT00749411|Drug|Placebo|matching placebo
16285692|NCT00749411|Drug|GSK233705/GW642444|The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
16285693|NCT00749398|Biological|Infliximab|According to local country regulations.
16285694|NCT00749385|Drug|PN 400|A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
16285695|NCT00749385|Drug|EC naproxen plus EC esomeprazole|Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
16285696|NCT00749385|Drug|EC naproxen|Enteric-coated naproxen tablet (500mg)
16285697|NCT00749385|Drug|EC esomeprazole|Enteric-coated esomeprazole capsule (20mg)
16285698|NCT00749372|Other|T2* Cardiac and Liver MRI|Patients will undergo an MRI of the heart and liver.
16285699|NCT00749359|Drug|Paxil CR|Paxil CR 37mg tablet manufactures at two different sites
16285700|NCT00749346|Device|NovoTTF-100L|TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
16285701|NCT00749333|Drug|AZD8566|solution. Specific dose will be selected by the safety review committee
16285702|NCT00749333|Drug|Placebo|Single 10ml oral solution.
16285703|NCT00749320|Other|Arterial Spin Labeling Magnetic Resonance Imaging|ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC
16285704|NCT00749307|Dietary Supplement|Docosahexaenoic acid (DHA)|
16285705|NCT00749307|Dietary Supplement|Placebo|
16285706|NCT00749268|Device|AbsorbaTack|Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.
16285707|NCT00749268|Device|ProTack|Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.
16285708|NCT00749242|Other|orthopedic brace|antalgic drugs and orthopedic brace
16285709|NCT00749242|Device|balloon kyphoplasty|introduction of balloon into the vertebral body, inflation of the balloon which creates a cavity, then balloon is deflated and removed , then introduction of the cement into the cavity.
16285710|NCT00749229|Device|balloon kyphoplasty|During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength
16285711|NCT00749216|Drug|Solanezumab|
16285712|NCT00749203|Drug|Midazolam|single dose 0.045 mg/kg IV infused over 40 minutes
16285713|NCT00749203|Drug|Ketamine|Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
16285714|NCT00749190|Drug|BI 10773|
16285715|NCT00749190|Drug|placebo|
16285716|NCT00749190|Drug|sitagliptin|
16285717|NCT00749177|Other|Traditional Healing options|Dream work, energy healing, healing circles, pipe ceremonies, self care, smudging, sweat lodges and traditional learning.
16285718|NCT00749164|Procedure|MSC transplantation|1-2X10^6 MSC per kg
16285719|NCT00749151|Behavioral|telephone counseling|First time callers to telephone help line agreed to one year follow-up on smoking cessation.
16285720|NCT00749138|Drug|tamoxifen|giving drug tamoxifen
16285721|NCT00749125|Drug|Lexapro|10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day
16285722|NCT00749112|Drug|Alemtuzumab, Rituximab|Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.
16285723|NCT00749099|Drug|pancrelipase|"The test drug (PANCRECARB® [pancrelipase] - Phase II) with a standardized Lundh meal.
~Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each)."
16285724|NCT00749099|Drug|placebo|"5 capsules of a placebo drug (Phase I) with a standardized Lundh meal.
~Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each)."
16285725|NCT00749086|Device|balloon kyphoplasty|Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. Then, the balloon are deflated and removed. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.
16285819|NCT00748293|Other|Low-residue diet|Commercialized (not yet marketed)low-residue diet
16285955|NCT00747162|Device|Measure of muscle oxygenation|The investigators will use an INVOS oxymeter for muscle oxygenation measure.
16285727|NCT00749073|Device|Minimally Invasive Lumbar Decompression (MILD™)|The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
16285728|NCT00749060|Other|conventional treatment|with our without brace
16285729|NCT00749060|Procedure|kyphoplasty with balloons|Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity.
16285730|NCT00749060|Procedure|vertebroplasty|Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance
16285731|NCT00749047|Drug|Pioglitazone|15-45 mg/day
16285732|NCT00749034|Biological|VPM1002|live vaccine
16285733|NCT00749034|Biological|BCG|commercially available live vaccine BCG
16285734|NCT00749021|Drug|Ranibizumab|0.5 mg of intravitreal ranibizumab monthly for 12 months
16285735|NCT00749021|Drug|Ranibizumab|0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
16285736|NCT00749021|Drug|Ranibizumab|2.0mg of intravitreal ranibizumab monthly for 12 months
16285737|NCT00749021|Drug|Ranibizumab|2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing
16285738|NCT00748982|Drug|AZD1305|iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
16285739|NCT00748982|Drug|Placebo|iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
16285740|NCT00748969|Drug|Somatropin (DNA origin)|The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month.
16285741|NCT00748956|Drug|Low dose NPY|50nmol, administered intranasally
16285742|NCT00748956|Drug|High dose NPY|100nmol administered intranasally
16285743|NCT00748956|Drug|Placebo|placebo comparator (0nmol)) administered intranasally
16285744|NCT00748943|Other|Chlorine Dioxide|Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
16285745|NCT00748930|Other|Retrospective Chart Review and Data collection|Retrospective Chart Review and Data collection
16285746|NCT00748904|Drug|Rifaximin|400 mg orally
16285747|NCT00748904|Drug|Lactulose|20 grams titrate to 2-3 bowel movements in one day
16285748|NCT00748891|Drug|Recentin (Cediranib)|30mg once daily, oral dose
16285749|NCT00748865|Other|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops 1 drop each eye one time
16285750|NCT00748865|Other|Systane Lubricant Eye Drops|Systane Lubricant Eye Drops 1 drop each eye one time
16285751|NCT00748852|Drug|JTT-302|JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
16285752|NCT00748826|Biological|Infliximab|"Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of
~Infliximab therapy with additional infusions of 5 mg/kg at week 2"
16285753|NCT00748813|Biological|Influenza Vaccine, Formulation 2008-2009|1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009
16285754|NCT00748800|Behavioral|Affect Management|5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training
16285755|NCT00748800|Behavioral|General Health Promotion|5 session group focused on delivering general health promotion information in didactic format
16285756|NCT00748787|Drug|Ispaghula husk|1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.
16285757|NCT00748787|Drug|Placebo|1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.
16285758|NCT00748774|Behavioral|Questionnaire|Two questionnaires taking about 10 minutes to complete.
16285759|NCT00748761|Behavioral|Cognitive Behavioral Therapy (CBT)|Nondrug psychotherapy administered weekly for 12 weeks
16285760|NCT00748761|Behavioral|Waitlist|Contact waitlist weekly for 12 weeks
16285761|NCT00748748|Biological|Culturelle|10^10 Lactobacillus rhamnosus GG per capsule
16285762|NCT00748735|Procedure|Implantation of a cardiac resynchronization therapy device|
16285763|NCT00748735|Procedure|Echocardiography (myocardial deformation imaging)|
16285764|NCT00748722|Device|CT Angiography|Injection of contrast material (iodine)
16285765|NCT00748709|Drug|BIBW 2992 (Afatinib)|BIBW 2992 (Afatininb) for patients FISH positive for/or harboring EGFR or HER2 Mutation
16285766|NCT00748696|Dietary Supplement|Fortimel Extra®|260kcal and 20g protein per day
16285767|NCT00748696|Other|resistance training|3 sessions of resistance training per week
16285768|NCT00748696|Other|combined treatment|260kcal and 20g protein per day 3 sessions of resistance training per week
16285769|NCT00748683|Other|RFID|A RFID tag attached on subjects' clothes 24hr a day during 1 month.
16285770|NCT00748670|Device|Fixture MicroThread (Micro-Macro)|Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.
16285771|NCT00748657|Biological|Bevacizumab|Given IV
16285772|NCT00748657|Other|Laboratory Biomarker Analysis|Correlative studies
16285773|NCT00748644|Drug|Rituximab|"rituximab infusion will be performed at J1, J15, M6, M12 and M18(i.e. a total of 5 infusions), at the dose of 500 mg at a fixed dosage.
~All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis."
16286419|NCT00743405|Drug|Placebo|To match GSK1034702
16285774|NCT00748644|Drug|Azathioprine|"azathioprine (2 mg/kg/d) for 12 months, then progressively tapered until its discontinuation at month 22.
~All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis."
16285775|NCT00748631|Device|balloon kyphoplasty|A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach.Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity.The balloons are then deflated and removed. The Bone Filler Device is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula.
16285776|NCT00748618|Dietary Supplement|vitamin D3|10,000 I.U./wk of vitamin D3 orally for 6 months
16285777|NCT00748618|Dietary Supplement|vitamin D3|50,000 I.U./wk of vitamin D3 orally for 6 months
16285778|NCT00748605|Drug|S-2367 Placebo|Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks
16285779|NCT00748605|Drug|S-2367 1600 mg q.d. 54 Weeks|Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks
16285780|NCT00748605|Drug|S-2367 1600 mg q.d. 60 weeks|Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks
16285781|NCT00748605|Other|LCD (low calorie diet)|A low calorie diet was utilized during the first 6 weeks of the study
16285782|NCT00748605|Other|RCD (reduced calorie diet)|A reduced calorie diet was used during the last 54 weeks for the study
16285783|NCT00748592|Drug|Placebo|Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
16285784|NCT00748592|Drug|PD 0200390|Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
16285785|NCT00748592|Drug|PD 0200390|Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
16285786|NCT00748592|Drug|PD 0200390|Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
16285787|NCT00748579|Drug|CK-1827452|I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
16285788|NCT00748579|Drug|CK-1827452|I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr
16285789|NCT00748566|Drug|Ziprasidone HCL (oral)|Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
16285790|NCT00748553|Drug|Azacitidine (Vidaza)|50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
16285791|NCT00748553|Drug|Nab-paclitaxel (Abraxane)|100mg/m2 weekly for 3 weeks of each 4-week cycle
16285792|NCT00748540|Device|Vibrant Soundbridge|Mixed and conductive hearing loss using round window stimulation
16285793|NCT00748527|Drug|carboplatin|Given IV
16285794|NCT00748527|Drug|decitabine|Given IV
16285795|NCT00748501|Drug|SB-509|Intramuscular injection of 60 mg of SB-509. Two doses on Day 0 and Day 90.
16285796|NCT00748488|Other|Physical therapy aimed to move safely|"Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease solely focused on safety of movement.
~Duration program: 2 years Maximum number of sessions: 35 per year Duration sessions: 30 minutes"
16285797|NCT00748488|Other|Physical Therapy aimed to improve Physical Activity|Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease combined with a coaching program aimed to promote the level of physical activity Duration program: 2 years Maximum number of sessions: 35 per year Duration of sessions: 30 minutes
16285798|NCT00748475|Behavioral|Neurofeedback|
16285799|NCT00748462|Device|Fractional CO2 Laser|"the treatment settings:
~Pulse duration : 5 to 7ms depending on skin reaction
~Spot Density: 49 MTZ/cm2 (Low density)
~Power: 15 W = (75 - 105) mJ/MTZ"
16285800|NCT00748449|Procedure|Colonoscopy|1 Colonoscopy
16285801|NCT00748449|Procedure|CT-colonography|1 CT-colonography; Procedure/Surgery/Radiation
16285802|NCT00748436|Drug|betahistine dihydrochloride|(24mg tablet Betahistine + placebo tablet) BID per os 12 weeks
16285803|NCT00748436|Drug|betahistine dihydrochloride|(24mg tablet Betahistine + 24mg tablet Betahistine) BID per os 12 weeks
16285804|NCT00748436|Drug|placebo|(placebo tablet + placebo tablet) BID per os 12 weeks
16285805|NCT00748423|Drug|Nitric Oxide|NO in inhalation for 3 days
16285806|NCT00748423|Drug|Placebo|Placebo in inhalation for 3 days
16285807|NCT00748410|Drug|SB-656933|7 days repeat dose
16285808|NCT00748397|Device|Fixture MicroThread (Micro-Macro)|Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.
16285809|NCT00748371|Drug|aspirin|40mg aspirin: one 40-mg aspirin capsule by mouth each morning + one Avicel capsule by mouth each evening
16285810|NCT00748371|Drug|aspirin|1300mg aspirin: one 650-mg capsule by mouth twice daily
16285811|NCT00748371|Drug|placebo|Placebo: one Avicel (cellulose) capsule by mouth twice daily
16285812|NCT00748358|Drug|sunitinib|37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.
16285813|NCT00748345|Drug|Caspofungin (drug)|pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population
16285814|NCT00748332|Dietary Supplement|Fortimel Extra®|2 bottles (600 kcal, 40 g proteins) per day
16285815|NCT00748332|Dietary Supplement|Fortimel Care®|Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day
16285816|NCT00748319|Other|Detection of KIR receptor by RT PCR|Detection on biopsy cutaneous (3mm) and on blood sample of 30 ml
16285817|NCT00748306|Drug|GSK2190915 - 100mcg|GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor
16285818|NCT00748306|Drug|Placebo|Matching Intervention Drug
16285820|NCT00748280|Procedure|One-visit root canal therapy|Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.
16285821|NCT00748280|Procedure|pulpotomy|Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.
16285822|NCT00748267|Other|questionnaire administration|
16285823|NCT00748267|Procedure|hypnotherapy|
16285824|NCT00748267|Procedure|therapeutic conventional surgery|
16285825|NCT00748254|Procedure|Laser Based Photoacoustic Tomography, MRI, Ultrasound|Healthy subjects will have scans on finger joints with any of the scanning methods described above.
16285826|NCT00748254|Procedure|laser based photoacoustic tomography, MRI, ultrasound|Subjects with arthritis will have scans on finger joints with any of the scanning methods described above.
16285827|NCT00748241|Device|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
16285828|NCT00748228|Dietary Supplement|dietary sodium|10 mEq/day
16285829|NCT00748228|Dietary Supplement|dietary sodium|300 mEq/day
16285830|NCT00748228|Dietary Supplement|dietary sodium|150 mEq/day dietary sodium
16285831|NCT00748215|Drug|calcium aluminosilicate anti-diarrheal|Given orally
16285832|NCT00748215|Other|placebo|Given orally
16285833|NCT00748202|Drug|C1-Esterase Inhibitor|1000 I.E.
16285834|NCT00748189|Drug|chlorambucil, tablets|2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
16285835|NCT00748189|Drug|ofatumumab (GSK1841157) infusion|iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
16285836|NCT00748176|Procedure|spinal anesthesia|spinal anesthesia with bupivacaine
16285837|NCT00748163|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16285838|NCT00748163|Drug|sunitinib malate|
16285839|NCT00748150|Biological|Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009|1 dose, 0.5 mL of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009
16285840|NCT00748137|Device|ezy-BICC dose calculation card|small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject
16285841|NCT00748137|Other|Fixed dose|Approach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target
16285842|NCT00748124|Device|PleuraSeal Sealant System|Lung Sealant Device + standard tissue closing techniques (sutures/staples)
16285843|NCT00748124|Procedure|Standard Tissue Closure Techniques|Standard tissue closure techniques (sutures/ staples) alone
16285844|NCT00748111|Other|Blood sample|Blood sample and thrombus sample
16285845|NCT00748098|Drug|GSK1838262 Extended Release Tablets|GSK1838262 extended release tablets
16285846|NCT00748098|Drug|Placebo|Placebo
16285847|NCT00748085|Device|CryoSpray Ablation|Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment. Subjects may undergo up to one bronchoscopy with CryoSpray Ablation every seven days for a total of four (4) treatments in the first month.
16285848|NCT00748072|Drug|DDAVP|0.3 mcg/kg subcutaneous
16285849|NCT00748072|Drug|saline solution|saline solution 1 ml subcutaneous
16285850|NCT00748059|Procedure|Standing or upright tilt|stand upright or tilt table test
16285851|NCT00748059|Procedure|Microneurography|Recording from sympathetic nerve
16285852|NCT00748059|Procedure|QSweat|quantitative sweat testing
16285853|NCT00748059|Device|neck cuff stimulation|Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.
16285854|NCT00748059|Drug|phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine|"IV Pharmacological Testing
~phenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect"
16285855|NCT00748059|Drug|clonidine,yohimbine,metoclopramide,alpha-methyldopa|"Oral Pharmacological Testing
~clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo"
16285856|NCT00748059|Procedure|BodPod|Determination of body composition
16285857|NCT00748059|Procedure|Eye exam|"Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:
~0.5% proparacaine (Alcaine, Allergan, Inc)
~Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)
~0.5%, 1% tropicamide (Mydriacyl, Alcon)
~Over-the-counter preservative-free artificial tears
~0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)
~1% cyclopentolate hydrochloride (Alcon)"
16285858|NCT00748059|Procedure|Sleep study|Recording of sleep pattern overnight
16285859|NCT00748059|Procedure|Pain response testing|Subjects will rate the quality and intensity of 2 pain tasks.
16285860|NCT00748059|Procedure|Metabolic chamber|Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter
16285861|NCT00748059|Procedure|Brain function studies|Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.
16285862|NCT00748059|Procedure|Bicycle Exercise Test|Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.
16285863|NCT00748046|Drug|Radium-223 chloride (BAY88-8223)|The required volume of study drug to be administered to a patient was calculated using the patient's body weight.
16285864|NCT00748033|Device|Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12|The subjects were first catheterized with this reference catheter.
16285865|NCT00748033|Device|LoFric POBE Hydro-Kit II, 5 seconds|An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds
16285866|NCT00748033|Device|LoFric POBE Hydro-Kit II, 24 hours|An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours
16285867|NCT00748020|Procedure|UVB phototherapy|Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
16285868|NCT00748020|Procedure|UVB phototherapy|Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose
16285869|NCT00748007|Drug|Rivastigmine|Exelon (1.5mg/cap) 1.5 mg bid
16285870|NCT00747981|Procedure|Thoracic CT Scan|Perform a CT Scan and an endoscopy
16285871|NCT00747968|Drug|Byetta, Exenatide|Drug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmol*kg-1*min-1 Duration: 5 hours Frequency: Drug given once, placebo given once
16285872|NCT00747942|Behavioral|Support for Increased Physical Activity|Exercise referral combined with individual support, access to structured group exercise programs, and motivational support
16285873|NCT00747929|Drug|S-2367 Placebo|four placebo tablets (total dose = 0 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks,
16285874|NCT00747929|Drug|S-2367 800 mg|two 400 mg S-2367 tablets (total dose = 800 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks
16285875|NCT00747929|Drug|S-2367 1600 mg|four 400 mg S-2367 tablets (total dose = 1600 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for total of 54 weeks,
16285876|NCT00747929|Other|Reduced Calorie Diet|A diet with restricted calorie content
16285877|NCT00747916|Device|CryoSpray Ablation (TM) System|Subjects will be treated with spray cryotherapy using the CryoSpray Ablation (TM) System at Day 0 using up to 3 cycles of 10-40 second sprays as the studied dosimetry and will cover the affected area, including the tumor and the parietal pleural surface. If disease exists bilaterally, only one side will be sprayed. Subjects will be assessed 2-5 days from the initial treatment (Day 0) to check for mucosal sloughing, to reassess tumor burden and for additional CSA therapy as needed.
16285878|NCT00747903|Drug|aminolevulinic acid hydrochloride|
16285879|NCT00747890|Procedure|Modified tonsillectomy|"Tonsillectomy
~Uvulectomy
~Soft palatal resection
~Lifestyle counselling by physician: General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance"
16285880|NCT00747890|Other|Lifestyle counselling by physician|General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.
16285881|NCT00747877|Drug|cyclophosphamide|Given orally
16285882|NCT00747877|Drug|melphalan|Given IV
16285883|NCT00747877|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous hematopoietic stem cell transplantation on day 0.
16285884|NCT00747838|Procedure|Minimally Invasive Maze Procedure|Minimally Invasive Surgical Correction of Atrial Fibrillation.
16285885|NCT00747825|Drug|131-I-MIP-1145|IV injection between 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145
16285886|NCT00747812|Device|Precision|Implantable Neurostimulator
16285887|NCT00747799|Drug|Sorafenib plus Cisplatin and 5-fluorouracil|"Sorafenib with Cisplatin and 5-fluorouracil as first-line treatment of recurrence after radiotherapy patients who failed with radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC)
~Sorafenib 400 mg bid per daily . Every 21-day cycles.
~Cisplatin 80 mg/m2 day d1, every 21 days cycle.
~5-fluorouracil 1000 mg/m2 day CIV 4days, repeat 21-day cycles"
16285888|NCT00747773|Device|CryoSpray Ablation System|"CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications (K070893). As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold"
16285889|NCT00747747|Biological|Saline solution|3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
16285890|NCT00747747|Device|Sinuclean DM Spray|3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
16285891|NCT00747734|Drug|MNRP1685A|Escalating intravenous dose
16285892|NCT00747721|Drug|Dexmedetomidine|2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.
16285893|NCT00747708|Drug|Granulocyte-colony stimulating factor|5 days subcutaneous injection
16285894|NCT00747708|Procedure|Percutaneous intracoronary injection|Bone marrow derived stem/progenitor cells or placebo infusion is delivered through an over-the-wire balloon catheter into the target coronary vessels using a stop-flow technique.
16285895|NCT00747708|Procedure|Percutaneous intramyocardial injection|Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system
16285896|NCT00747695|Drug|Rabeprazole sodium|
16285897|NCT00747669|Drug|lidocaine 70mg and tetracaine 70mg topical patch|One Synera Patch applied for 30 minutes.
16285898|NCT00747643|Drug|varenicline|Participants in this group received varenicline according to the schedule in the Arm Description.
16285899|NCT00747643|Drug|placebo|Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.
16285900|NCT00747630|Other|An educational video about Fetal Alcohol Syndrome|A 20 minute video about FAS
16285901|NCT00747617|Drug|recombinant human chorionic gonadotropin|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
16285902|NCT00747604|Biological|mecasermin [rDNA origin] injection|As prescribed by the physician.
16285903|NCT00747565|Device|Tecnis ZM900 Multifocal Intraocular Lens|Investigational intraocular lens
16285904|NCT00747565|Device|CeeOn 911A monofocal IOL|Monofocal Control IOL
16285953|NCT00747175|Drug|AZD1656|Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
16285905|NCT00747539|Drug|Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)|Pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV, will be given to participants.
16285906|NCT00747526|Drug|Rabeprazole sodium 5 mg|Type= exact number, unit= mg, number= 5, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to Day 5; possible extension using 5 mg once daily up to 28 consecutive days.
16285907|NCT00747526|Drug|Rabeprazole sodium 10 mg|Type= exact number, unit= mg, number= 10, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to up to Day 14; possible extension using 10 mg once daily up to 28 consecutive days.
16285908|NCT00747513|Behavioral|lifestyle program|a comprehensive program designed to encourage healthier food choices and eating habits and increased physical activity among children, by use of school, family and community measures.
16285909|NCT00747487|Drug|Idebenone|Idebenone 900 mg/day
16285910|NCT00747487|Drug|Placebo|Placebo
16285911|NCT00747474|Drug|Lipotecan|Lipotecan IV day 1, 8, 15
16285912|NCT00747461|Device|CryoSpray Ablation|Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
16285913|NCT00747435|Device|Electric Acoustic System|Combination of a cochlear implant and a hearing aid
16285914|NCT00747422|Device|Ulthera™ System|ultrasound treatment
16285915|NCT00747409|Drug|insulin aspart and detemir (NovoRapid, Levemir)|use of basal-bolus therapy with insulin aspart and detemir
16285916|NCT00747409|Drug|human regular insulin and NPH insulin (Actrapid, Protaphne)|basal-bolus therapy with human regular and NPH insulin
16285917|NCT00747396|Other|Foster Care Placement|A group of children living in institutions in Bucharest, Romania was randomly assigned to placement in foster care. Foster parents were recruited, consented to background checks, and trained in Romanian. Before placement, foster parents visited their children to begin developing a relationship with the child. Hired foster parents were supported and monitored by project social workers. Foster parents in the BEIP network received frequent visits from the social workers, with visits occurring weekly for several months after placement of the child, then biweekly and later monthly. Foster parents were invited to participate in a support group organized by social workers. Project social workers consulted weekly with US staff experienced in dealing with young children in foster care.
16285918|NCT00747383|Drug|Glimepiride|3mg oral tablet.
16285919|NCT00747383|Drug|Sitagliptin|100mg oral tablet.
16285920|NCT00747370|Procedure|movement of midurethra, bladder neck, cervix and rectum|
16285921|NCT00747357|Device|Drug Eluting Balloon SeQuent Please|Drug Eluting Balloon is followed by Bare Metal Stent
16285922|NCT00747357|Device|Drug Eluting Balloon SeQuent Please|Bare Metal Stent followed by Drug Eluting Balloon
16285923|NCT00747344|Drug|Placebo - Controlled Period (CP)|Placebo, Weeks 0-12
16285924|NCT00747344|Drug|Ustekinumab 45 mg - CP|Ustekinumab 45 mg, Weeks 0-12
16285925|NCT00747344|Drug|Placebo to ustekinumab 45 mg - after CP|Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16
16285926|NCT00747344|Drug|Ustekinumab 45 mg - after CP|Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16
16285927|NCT00747331|Drug|Fenoldopam mesilate|Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation
16285928|NCT00747331|Drug|Placebo|"Intravenous infusion (saline)
~Infused at the same rate (ml/h) as the experimental drug"
16285929|NCT00747318|Drug|SKP FlutiForm HFA pMDI|Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.
16285930|NCT00747305|Drug|sunitinib malate|
16285931|NCT00747305|Genetic|gene expression analysis|
16285932|NCT00747305|Genetic|reverse transcriptase-polymerase chain reaction|
16285933|NCT00747305|Genetic|western blotting|
16285934|NCT00747305|Other|immunohistochemistry staining method|
16285935|NCT00747305|Other|laboratory biomarker analysis|
16285936|NCT00747305|Procedure|adjuvant therapy|
16285937|NCT00747305|Procedure|neoadjuvant therapy|
16285938|NCT00747305|Procedure|therapeutic conventional surgery|
16285939|NCT00747292|Procedure|epidural|Patients in this limb receive epidural analgesia
16285940|NCT00747292|Procedure|PCA|Patients in this limb receive a PCA for their pain control
16285941|NCT00747292|Procedure|Spinal|Patients in limb will receive spinal analgesia
16285942|NCT00747279|Other|Carbohydrate restrictive strategy|Patients will receive intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16.7% proteins and 50% lipids. These patients will receive regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and in stable patients, ideally below 150 mg/dl.
16285943|NCT00747279|Drug|Intensive insulin therapy|Continuous intravenous regular insulin infusion will be adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 and 120 mg/dl. Patients will be submitted to capillary glycemic measurements every 2 hours. The insulin dose is adjusted according to an algorithm run by nurses and overseen by physicians. These patients will receive glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids.
16285944|NCT00747253|Device|AutoLITT system|laser treatment with the AutoLITT system
16285945|NCT00747227|Device|modified light transmission intraocular lens|violet visible light blocking acrylic intraocular lens
16285946|NCT00747227|Device|monofocal acrylic intraocular lens|conventional hydrophobic acrylic intraocular lens
16285947|NCT00747214|Drug|CRx-102|
16285948|NCT00747214|Drug|Placebo|
16285949|NCT00747214|Drug|DMARD Therapy|DMARD therapy can include methotrexate or other DMARD therapy
16285950|NCT00747201|Behavioral|Replicating Effective Programs Framework for the Bipolar Care Model|Health care providers will receive adapted manuals, training, and technical assistance in the bipolar care model.
16285951|NCT00747201|Behavioral|Bipolar Care Model Package Only|Health care providers will receive only the adapted manuals.
16285952|NCT00747188|Behavioral|PBL|
16285956|NCT00747162|Device|Skin pigmentation determination|The investigators will use a DermaSpectrometer to get a reading from subjects' skin color
16285957|NCT00747149|Drug|Rosuvastatin|Oral
16285958|NCT00747123|Biological|ACE-011|ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
16285959|NCT00747123|Biological|Placebo|Placebo given by the subcutaneous route of administration monthly for 4 doses.
16285960|NCT00747110|Drug|budesonide|3x 3mg budesonide capsules once daily
16285961|NCT00747110|Drug|mesalazine|3x 1000mg mesalazine onc daily
16285962|NCT00747097|Drug|gemcitabine + cetuximab|gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment
16285963|NCT00747084|Procedure|Colonoscopy|The purpose of the study is to conduct an RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy.
16285964|NCT00747071|Drug|Colostrum|Daily administration of Colostrum derived antibodies against C. difficile.
16285965|NCT00747058|Drug|PF-3864086|The dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.
16285966|NCT00747058|Drug|Placebo|Placebo
16285967|NCT00747045|Other|Ventilation Strategy|Comparison of low vs standard tidal volumes in patients undergoing PTE
16285968|NCT00747032|Drug|NYC 0462 Ointment|To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
16285969|NCT00747032|Drug|Placebo|To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
16285970|NCT00747019|Behavioral|Prosocial Behavior Physical Activity (PBPA)|The PBPA condition involves a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9. PBPA participants also earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity.
16285971|NCT00747019|Behavioral|Physical Exercise (PE)|The PE condition is a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9.
16285972|NCT00747006|Drug|TI Inhalation Powder and Humalog (Amendment 1)|Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.
16285973|NCT00747006|Drug|TI Inhalation Powder (original protocol)|Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
16285974|NCT00746993|Other|Structured contraceptive counseling|Uniform set of visual information about contraception which a counselor will read out loud with each participant and answer questions.
16285975|NCT00746980|Drug|efalizumab|1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.
16285976|NCT00746967|Drug|sildenafil|sildenafil 50 mg (starting dose) tablet by mouth taken as needed 1 hour before anticipated sexual activity; the dose could be increased to 100 mg or decreased to 25 mg; the duration of therapy in this open-label study was 52 weeks
16285977|NCT00746954|Drug|Acetazolamide|Cabonic Anhydrase inhibitor
16285978|NCT00746954|Drug|Buspirone|Agonist of a 5-HT1a receptor with some D2 agonist properties.
16285979|NCT00746941|Drug|mefloquine|250 mg orally each day for 3 days and then weekly up to 6 months.
16285980|NCT00746928|Other|Chronic Intermittent Hypoxia|Chronic Intermittent Hypoxia mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome, is applied to Healthy subject during 8 hours a day (nights) for a 14 days period. The cycle of intermittent Hypoxia is 30 drop in SaO2 per hours with a 10% decrease in SaO2.
16285981|NCT00746915|Device|EpiDetect|During the epidural needle insertion, data will be collected to characterize in real-time the electrical bioimpedance properties of the types of tissue along the path of the needle.
16285982|NCT00746902|Device|nCPAP|Active nCPAP
16285983|NCT00746889|Drug|triamcinolone acetonide|single intraarticular injection of 40 mg of triamcinolone acetonide
16285984|NCT00746889|Drug|saline|Single intraarticular injection of 1 ml of 0.9% saline
16285985|NCT00746876|Device|Unipolar hip hemiarthroplasty|Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
16285986|NCT00746876|Device|Bipolar hip hemiarthroplasty|Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures
16285987|NCT00746863|Drug|0.125% Marcaine|Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
16285988|NCT00746850|Procedure|early LC within 72 hours after the diagnosis with H (Harmonic)|early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with H (Harmonic scalpel)
16285989|NCT00746850|Procedure|early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy)|early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with MD (Monopolar Diathermy)
16285990|NCT00746837|Drug|AZD5672|single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
16285991|NCT00746837|Drug|AZD5672|50 mg od, 12 days
16285992|NCT00746837|Drug|AZD5672|150mg od, 12 days
16285993|NCT00746824|Drug|TM30339 and/or placebo|The drug and/or placebo will be injected in the abdominal area (site to vary for each injection). Injections will be administered twice daily for 28 days.
16285994|NCT00746811|Drug|P-OM3|4 grams/day - 4 one gram capsules
16285995|NCT00746811|Drug|Placebo|4 grams/day - 4 one gram capsules
16285996|NCT00746798|Biological|ChimeriVax-WN02 vaccine|low dose, approximately 4 x 3log10, given one time subcutaneously
16285997|NCT00746798|Biological|ChimeriVax-WN02 vaccine|medium dose, approximately 4 x 4log10, given one time
16286939|NCT00739791|Genetic|proteomic profiling|
16285998|NCT00746798|Biological|ChimeriVax-WN02 vaccine|high dose, approximately 4 x 5log10, given one time subcutaneously
16285999|NCT00746798|Biological|Placebo|0.9%Normal Saline for Injection, given one time subcutaneously
16286000|NCT00746785|Drug|2.5 mg Olanzapine|2.5 mg
16286001|NCT00746785|Drug|5mg Olanzapine|5 mg
16286002|NCT00746785|Drug|placebo|placebo
16286003|NCT00746772|Drug|Purslane 235mg/day in one dosage|Patients had been clinically with OLP and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, types, size, and site of the lesions , duration of disease and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received systemic Purslane CAP with concentration antioxidant 235 mg/day in 1 dosage and second group used placebo CAP for 3 month. Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and every 1 month up to 6 months
16286004|NCT00746772|Drug|Placebo : one dosage|Patients had been clinically with OLP and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, types, size, and site of the lesions , duration of disease and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received systemic Purslane CAP with concentration antioxidant 235 mg/day in 1 dosage and second group used placebo CAP for 3 month. Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and every 1 month up to 6 months .
16286005|NCT00746759|Device|Biomarker (not used as an intervention)|This study is an observational study. There is no intervention.
16286006|NCT00746746|Biological|HyperAcute vaccine|1.8 mL weekly
16286007|NCT00746746|Drug|Pegylated Interferon-Alpha 2b|6.0 mcg/kg weekly
16286008|NCT00746733|Drug|Lisdexamfetamine Dimesylate|50mg capsule
16286009|NCT00746733|Drug|Adderall XR (mixed salts amphetamine)|20mg capsule
16286010|NCT00746720|Drug|Etoricoxib 60 mg|film coated tablet 60 mg (orally), 120 mg (= 2 tablets a 60 mg) once daily, on day one post surgery
16286011|NCT00746720|Drug|Placebo for Etoricoxib 60 mg|film coated tablet (orally), two tablets once daily, on day one post surgery
16286012|NCT00746720|Drug|Etoricoxib 60 mg|film coated tablet (orally), 120 mg (= 2 tablets a 60 mg) once daily, two hours before and 24 hours after surgery
16286013|NCT00746720|Drug|Placebo for Etoricoxib 60 mg|film coated tablet (orally), 2 tablets once daily, two hours before and 24 hours after surgery
16286014|NCT00746707|Device|1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate|adhesive of perineal tears
16286015|NCT00746707|Procedure|3. traditional suturing with vicryl rapid 2X0|suturing of perineal tears grade one with vicryl rapid 2X0
16286016|NCT00746681|Drug|Tolterodine & Pregabalin|Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
16286017|NCT00746681|Drug|Tolterodine|Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
16286018|NCT00746681|Drug|Placebo|Placebo, Oral, twice daily for 4 weeks
16286019|NCT00746681|Drug|Tolterodine & Pregabalin|Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
16286020|NCT00746681|Drug|Pregabalin|Pregabalin, Oral, 150 mg twice daily for 4 weeks
16286021|NCT00746668|Behavioral|Module 1: Visual Awareness and Eccentric Viewing|"In this module, awareness of the PRL location and eccentric viewing were trained. Exercises based on published sources were administered. One example of these exercises is the clock face display adapted from Holcomb and Goodrich and Maplesden.
~This module also focused on awareness of the perceptual consequences of using a PRL. The purpose of these training exercises was to allow the subjects to appreciate perceptual alterations that occur when using a PRL and to practice making perceptual discriminations with the peripheral retina. Previously published work has demonstrated that perception in the peripheral retina can be affected by practice."
16286022|NCT00746668|Behavioral|Module 2: Control of Reading Eye Movements|In this module, control of eye movements was trained. These exercises began with a series of saccade tasks to nonalphabetical stimuli and then progressed to single letter, letter pairs, and word stimuli. Subjects were instructed to make a saccade between the dots. The experimenter provided feedback concerning the appropriateness of the saccades, and the alternation rate of the dots was increased as performance improved.
16286023|NCT00746668|Behavioral|Module 3: Reading Practice with RSVP|In module 3, we wanted to assess only the higher-level effects of reading practice. Subjects practiced reading using stimuli that did not require reading eye movements. An example is short sentences that were presented one word at a time at a single location on a screen (Rapid Serial Visual Presentation [RSVP]). At the end of the sentence, subjects reported whether the sentence made sense or not. We also had our subjects practice reading scrolled text. Although, eye movements and saccades may spontaneously occur under the text presentation conditions of this module, they are not the efficient saccades necessary for reading.
16286024|NCT00746655|Radiation|Stereotactic Body Radiation Therapy (SBRT)|The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
16286025|NCT00746655|Procedure|Transcatheter Arterial Chemoembolization (TACE)|. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
16286026|NCT00746642|Device|Mellitor device for glucose measurement|"Glucose measurement using Mellitor device"
16286063|NCT00746343|Behavioral|PCCM|Subjects will remain in their assigned treatment condition for 24 months.
16286064|NCT00746330|Drug|Mometasone furoate/formoterol fumarate (MFF)|Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
16286065|NCT00746330|Drug|Formoterol fumarate 12 μg pMDI (F12M)|Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
16286066|NCT00746330|Drug|Formoterol fumarate 12 μg DPI (F12D)|Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
16286940|NCT00739791|Genetic|reverse transcriptase-polymerase chain reaction|
16286027|NCT00746629|Behavioral|FOCUS|"Treatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are prescribed or self-directed. Children and parents will be weighed at each clinic visit."
16286028|NCT00746616|Device|Durom Hip Resurfacing System|Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
16286029|NCT00746603|Drug|Simvastatin|All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
16286030|NCT00746590|Drug|Prolarix (tretazicar co-administered with caricotamide)|Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
16286031|NCT00746577|Other|Organizational change to improve the implementation of evidence-based practices.|Some sites will receive assistance with the creation and implementation of an organizational development plan.
16286032|NCT00746564|Device|SJM Confirm|All patients in this study will receive the SJM Confirm device.
16286033|NCT00746551|Drug|Ferli-6® (Continental Pharm co., ltd.)|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
16286034|NCT00746551|Drug|Venofer® (Vifor AG, St. Gallen, Switzerland)|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
16286035|NCT00746538|Device|biliary stent|Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
16286036|NCT00746525|Other|Surface functional electrical stimulation (FES)|FES is a technique that electrically stimulates a muscle in a comfortable manner in order to contract the muscle. It uses an electrode placed on the surface of the skin. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
16286037|NCT00746525|Other|Motor learning|Motor learning is an exercise that uses movements needed for everyday tasks such as picking up a glass or opening a book. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
16286038|NCT00746525|Other|Brain computer interface (BCI) training|BCI training uses signals produced by the brain to help individuals with stroke move their weak arm. This study will use BCI, FES and motor learning interventions to address upper extremity motor deficits following stroke.
16286039|NCT00746512|Drug|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days.
16286040|NCT00746512|Drug|Placebo Tablets|Prednisone placebo tablets once daily for 15 days.
16286041|NCT00746512|Drug|Prednisone 7.5 mg|Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
16286042|NCT00746512|Drug|Placebo Over-Encapsulated Tablets|Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
16286043|NCT00746499|Drug|Raltegravir|400mg raltegravir BID x 7 days
16286044|NCT00746486|Drug|budesonide|One budesonide 3 mg capsule TD or one budesonide 3 mg capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d for 3 years
16286045|NCT00746486|Drug|budesonide placebo|One placebo capsule TD or One placebo capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d for 3 years
16286046|NCT00746460|Behavioral|CVD risk profile|Cardiovascular risk assessment and behavioral counselling
16286047|NCT00746447|Drug|mesalamine granules|3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
16286048|NCT00746447|Drug|mesalamine granules|1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
16286049|NCT00746447|Drug|mesalamine granules|0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
16286050|NCT00746434|Drug|Roflumilast cream|Roflumilast cream 0.5%
16286051|NCT00746434|Drug|Placebo cream|Placebo cream
16286052|NCT00746421|Drug|Quetiapine XR|oral doses, 200 mg, 300 mg, 400 mg
16286053|NCT00746421|Drug|Placebo|200mg, 300mg or 400mg
16286054|NCT00746408|Other|Expert system guided tailored information|The prototype is realised by a web-based information system. The HTML web-interface guides the user through the search process by querying the information demand. This is done by an integrated expert system. The expert system uses a rule based inference to determine an internal diagnosis. Based on this internal diagnosis the system searches quality labeled websites and presents relevant information to the user.
16286055|NCT00746395|Drug|Lubiprostone|24 mcg oral administration
16286056|NCT00746395|Drug|Placebo|Oral administration
16286057|NCT00746382|Drug|Roflumilast cream|Roflumilast cream 0.5% versus Placebo cream
16286058|NCT00746382|Drug|Placebo cream|Placebo cream
16286059|NCT00746369|Behavioral|IMARA HIV Prevention Intervention|Three individual sessions- behavioral intervention for incarcerated female adolescents.
16286060|NCT00746356|Device|Testing of the autocapture features of the device|Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.
16286061|NCT00746356|Device|Testing of the autocapture features of the device|Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.
16286062|NCT00746343|Behavioral|IRRI|Subjects will remain in their assigned treatment condition for 24 months. IRRI subjects will meet with the lifestyle coach 25-27 times throughout the duration of the study.
16286941|NCT00739791|Other|laboratory biomarker analysis|
16286067|NCT00746330|Drug|Placebo to F12D|Placebo to formoterol fumarate DPI delivered via DPI
16286068|NCT00746330|Drug|Placebo to F12M/MFF|Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
16286069|NCT00746317|Drug|GC33|IV administration at 4 escalating dose levels.
16286070|NCT00746291|Other|6 min walk test, Step climbing|walking for 6 minute and climbing steps
16286071|NCT00746278|Procedure|Laparoscopic ovarian cystectomy using bipolar|Laparoscopic ovarian cystectomy using bipolar
16286072|NCT00746278|Procedure|Laparoscopic ovarian cystectomy using ultrasonic scalpel|Laparoscopic ovarian cystectomy using ultrasonic scalpel
16286073|NCT00746278|Procedure|Laparoscopic ovarian cystectomy using suture|Laparoscopic ovarian cystectomy using suture
16286074|NCT00746265|Behavioral|Behavioral weight loss intervention|Participants in both conditions are provided nutritional education and behavioral strategies for weight loss (consistent with the LEARN program). Participants in SBT are taught the cognitive and motivational strategies used in LEARN while participants in ABT are taught acceptance-based strategies (e.g., acceptance, mindfulness).
16286075|NCT00746252|Drug|risperidone|Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
16286076|NCT00746252|Drug|aripiprazole|children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
16286077|NCT00746239|Drug|Placebo and Escitalopram|Placebo and Escitalopram (5 to 40 mg)
16286078|NCT00746239|Drug|Ramelteon and Escitalopram|Ramelteon 8 mg and Escitalopram (5-40 mg)
16286079|NCT00746226|Biological|Lactobacillus acidophilus and Bifidobacterium lactis|Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis
16286080|NCT00746226|Biological|Placebo|"Microcrystalline cellulose
~As capsule which could be opened"
16286081|NCT00746200|Procedure|(electro)acupuncture|Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
16286082|NCT00746200|Procedure|sham acupuncture|Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds
16286083|NCT00746187|Device|ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.|
16286084|NCT00746187|Device|3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm|
16286085|NCT00746174|Drug|Rosiglitazone|Rosiglitazone 8mg PO daily for 16 weeks
16286086|NCT00746174|Drug|Placebo|Placebo 1 tablet PO daily for 16 weeks
16286087|NCT00746161|Procedure|Reconstruction after total gastrectomy|Roux-en-Y
16286088|NCT00746161|Procedure|Reconstruction after total gastrectomy|double tract reconstruction
16286089|NCT00746148|Other|Reflexology|10 weekly sessions of 45 minutes each
16286090|NCT00746135|Device|Device Implantation|RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
16286091|NCT00746122|Procedure|Open repair|Standard treatment of emergency open surgery
16286092|NCT00746122|Procedure|EVAR|Emergency endovascular aneurysm repair
16286093|NCT00746109|Procedure|Wound packing|"1/4 non-iodoform packing loosely placed inside abscess cavity."
16286094|NCT00746109|Procedure|NoPacking|This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
16286095|NCT00746096|Drug|IKH-01|ethinyl estradiol 0.035mg and norethisterone 1mg
16286096|NCT00746096|Drug|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
16286097|NCT00746083|Behavioral|Challenge!|"Each adolescent in the intervention group received 12 lessons administered in adolescent's home or community by a personal trainer (a college-aged mentor). The lessons focused on behavior change relating to diet and physical activity and was based on social cognitive theory. At the end of each lesson the adolescent set a behavior change goal for themselves. The adolescents were taught how to track their goals and they discussed thir ability/inability to meet their goals at each meeting with their personal trainer."
16286098|NCT00746070|Other|with the clinical treatment ( ex adrenalectomy or spironolactone|with the clinical observational study
16286099|NCT00746057|Biological|DNA chip|One biopsy is realized before graft, another biopsy is realized one year after graft and a blood sample is collected 3 months after graft to realize DNA chip. Blood samples are also collected at day 0, day 1, month 3, month 6 and month 12 to analyze biochemistry, proteinuria, haematology, creatinine clearance and immunology at day 0, month 3 and month 12.
16286100|NCT00746031|Drug|GnRH analogue (Zoladex)|3.6mg subcutaneous implant. Monthly doses x 3.
16286101|NCT00746031|Drug|GnRH antagonist-Cetrorelix|Subcutaneous injection 3mg x3 over 7 days
16286102|NCT00746018|Device|LigaSure vessel sealing system|The investigators intend to enroll a total of 60 patients planned to undergo a total hysterectomy and bilateral salpingo-oophorectomy. There will be two techniques compared in this protocol. The first 30 patients will have the right tube removed with one application of the LigaSure. The LigaSure will be placed and the most proximal portion of the right fallopian tube adjacent to the uterine cornua and will be used to coagulate and cut the tube. The next 30 patients will have the tube ligated in the same fashion as group A however an additional step will be added once the fallopian tube has been removed. The LigaSure will be used to cauterize the remaining medial tissue on the cornua region of the uterus.
16286103|NCT00746005|Dietary Supplement|fish oil|3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
16286104|NCT00746005|Dietary Supplement|placebo, sunflower oil|3 g of sunflower oil
16286105|NCT00745992|Other|Blood drawn (lab data)|"Check drug blood level 3-5 days after start of drug, treatment failure, occurence of adverse events, or clinically indicated
~Check genetic polymorphism of liver enzyme 3-5 days after start of drug"
16286106|NCT00745953|Drug|Valsartan|Valsartan 320mg PO daily for 8 months
16286107|NCT00745953|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25mg PO daily for 8 months
16286108|NCT00745940|Behavioral|MBCT for TBI|Subjects will participate in a 10-week Mindfulness-Based Cognitive Therapy Program led by two trained facilitators. Weekly one-and-a-half hour group sessions will guide subjects through exercises such as meditation, awareness, and breathing techniques aimed at developing skills to help with tension, stress, anxiety and depression. Subjects will be encouraged to practice skills at home and in daily life.
16286942|NCT00739791|Other|medical chart review|
16286109|NCT00745927|Other|CO2 insufflations|CO2 insufflations during whole procedure of colonoscopy
16286110|NCT00745914|Drug|Pioglitazone|oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
16286111|NCT00745914|Drug|Placebo comparator|Placebo comparator
16286112|NCT00745901|Drug|Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol|
16286113|NCT00745888|Other|Chemiluminescence Analyzer|measure reactive oxygen species
16286114|NCT00745875|Drug|ZD4054|10mg oral tablet, once daily
16286115|NCT00745875|Drug|Pemetrexed|500mg2/m IV infusion
16286116|NCT00745875|Drug|Placebo|10mg oral tablet, once daily
16286117|NCT00745862|Behavioral|questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided|This pilot study will measure illness related distress in female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment. Areas of particular focus will be survival anxiety, family functioning/childbearing concerns, and aesthetic impact of surgery. Patients will complete a one time only set of quality of life assessments these questionnaires will take 30-45 minutes to complete.
16286118|NCT00745849|Drug|esomeprazole|40mg by mouth twice daily
16286119|NCT00745849|Drug|placebo|
16286120|NCT00745836|Drug|statin|
16286121|NCT00745823|Drug|Comparator: Raltegravir 400 mg b.i.d.|Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)
16286122|NCT00745823|Drug|Experimental: Raltegravir 800 mg q.d.|Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.
16286123|NCT00745823|Drug|TRUVADA™|One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
16286124|NCT00745810|Other|Cardiopulmonary bypass|sequential changes of oxidative injuries before and after cardiopulmonary bypass
16286125|NCT00745797|Radiation|Radiotherapy|blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
16286126|NCT00745784|Behavioral|in-person or telephone interview|Participants will be administered one battery of questionnaires that should take 50- 55 minutes, which may be broken down into two or more segments if necessary. They may choose to have these questionnaires administered to them in person at the hospital, in person at their home, or via telephone by a trained master's level research assistant.
16286127|NCT00745771|Drug|Diractin|
16286128|NCT00745771|Drug|Diractin|
16286129|NCT00745745|Device|Device Implantation|ICD lead implantation
16286130|NCT00745732|Drug|ZD6474 (ZACTIMA)|ZD6474 (ZACTIMA) beginning at 100 mg once a day by mouth
16286131|NCT00745732|Radiation|Radiation Therapy|"Phase I: 45 Gy at 3 Gy per fractions once a day.
~Phase II: 45 Gy at 3 Gy per fraction once a day or 66-70 Gy at 2 Gy per fraction once a day."
16286132|NCT00745719|Procedure|parathyroidectomy|total parathyroidectomy with forearm autografting
16286133|NCT00745706|Device|Implantable Loop Recorder (ILR)|Insertion of ILR 3 months prior to clinical ablation procedure to collect data on actual Atrial Fibrillation episodes and correlation with patient symptoms through patient diary entry. Then patient undergoes their previously indicated clinical ablation procedure and is then followed up with ILR insitu for 30 months post-ablation for the same as mentioned above.
16286134|NCT00745693|Drug|Endothelin-1|Intra-arterial infusion of Endothelin-1 at 5pmol/min for 1 hour during venous occlusion plethysmography
16286135|NCT00745693|Drug|BQ-123 and BQ-788|1 hour intra-arterial infusion of BQ-123 at 10nmol/min followed by co-infusion of BQ-788 at 1nmol/min for a further hour during forearm venous occlusion plethysmography
16286136|NCT00745667|Procedure|laparoscopic surgery|laparoscopic correction perforated peptic ulcer
16286137|NCT00745667|Procedure|Upper laparotomy|upper laparotomy for correction of perforated peptic ulcer
16286138|NCT00745615|Drug|Laquinimod|Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
16286139|NCT00745615|Drug|Placebo|Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.
16286140|NCT00745602|Procedure|non-invasive testing|non-invasive tests including Transcranial Doppler ultrasound (TCD), manual cuff blood pressure (BP), beat to beat BP monitoring by a Portapress monitor, and respiratory tidal CO2
16286141|NCT00745589|Drug|sevelamer hydrochloride|First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)
16286142|NCT00745576|Drug|SAM-531|
16286143|NCT00745563|Device|Fertiligent|Fertility treatment by using the EVIE - Slow Release Insemination method
16286144|NCT00745550|Drug|SB1518|SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
16286145|NCT00745537|Other|repeated mood measures and phone depression care management|The adolescent mothers will be assigned a depression care management who will support the mother in making choices about depression treatment, educate about treatment options, discuss barriers and solutions, counsel to comply with treatment recommendations, and assisted to problem-solve if failure to respond occurs.
16286146|NCT00745511|Drug|ORA102 and Avastin|treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
16286147|NCT00745511|Drug|Avastin|treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
16286148|NCT00745498|Drug|Bevacizumab|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
16286149|NCT00745485|Drug|zoledronic acid|
16286150|NCT00745459|Drug|NPO-11|20 mL NPO-11
16286151|NCT00745446|Procedure|Forearm Venous Occlusion Plethysmography|Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery
16286152|NCT00745433|Drug|repaglinide|Start dose and frequency at the discretion of the physician following clinical practice
16286153|NCT00745433|Drug|metformin|Start dose and frequency at the discretion of the physician following clinical practice
16286248|NCT00744614|Procedure|Capnography|A technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases
16286249|NCT00744562|Drug|OMP-21M18|0.5, 1, 2.5, 5, and 10 mg/kg weekly until day 56. If patient has not progressed may continue with original dose administered every other week until progression
16286154|NCT00745420|Biological|Hematopoietic Stem Cell Transplantation|"The stem cell transplant preparative regimen is listed below. Day 0 is the day of the transplant. The - sign is the number of days before and the + sign is the number of days after the transplant.
~Alemtuzumab: Children weighing 10 kg or more will receive 10 mg, 15 mg, and 20 mg intravenously (IV) on Days -21, -20, and -19, respectively
~Fludarabine: 30 mg/m^2/day IV on Days -8 through -4
~Melphalan: 140 mg/m^2 IV on Day -3
~Rest on Days -2 and -1
~Transplant occurs on Day 0
~GVHD prophylaxis: Tacrolimus or cyclosporine beginning Day -3, methotrexate (7.5 mg/m2/day) Day 1, 3 and 6 and methylprednisolone/prednisone on Day +7 to +28 followed by a taper if there is no GVHD"
16286155|NCT00745407|Drug|fenofibrate|
16286156|NCT00745381|Other|questionnaire, Blood specimens|All participants will complete an epidemiology study questionnaire as well as a quality of life questionnaire. They will also be asked to donate blood samples. We will request participation in a tissue repository consisting of fresh frozen or paraffin embedded tissue. The repository will be of serum, plasma and tumor tissue. Follow-up will occur on patients every 6 months for the first year after consent and then annually.
16286157|NCT00745368|Drug|Raltegravir|400 mg tablets twice daily during duration of trial
16286158|NCT00745355|Behavioral|Quality Of Life questionnaires|All patients who agree to participate will be interviewed using a baseline idiographic quality of life assessment prior to surgery and at approximately 6, 12, 18 and 24 months postoperatively. All patients will also be asked to respond to a questionnaire including all standard measures (closed-ended, multiple choice items) before surgery and at approximately 3, 6, 12, 18 and 24 months post-surgery.
16286159|NCT00745342|Behavioral|Family Teamwork Intervention|Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.
16286160|NCT00745329|Other|sperm quality test|All participants will undergo sequential sperm quality tests and blood tests
16286161|NCT00745316|Drug|Tonapofylline|Oral Tonapofylline - 2 capsules bid
16286162|NCT00745316|Drug|Placebo|Oral placebo - 2 capsules bid
16286163|NCT00745303|Procedure|Tai Chi Cuan|Tai Chi Cuan training for 3 months
16286164|NCT00745290|Drug|Bupivacaine HCl|200 mg bupivacaine HCl
16286165|NCT00745290|Drug|SKY0402|600 mg SKY0402 (study drug).
16286166|NCT00745264|Drug|Diractin|100 mg Ketoprofen to 2 joints
16286167|NCT00745264|Drug|Diractin|400 mg ketoprofen to 4 joints
16286168|NCT00745264|Drug|Diractin|100 and 400 mg Ketoprofen used concomittant with heat
16286169|NCT00745264|Drug|Diractin|100 and 400 mg Ketoprofen concomittant with moderate exercise
16286170|NCT00745251|Drug|VI-0521|15 mg Phentermine and 92 mg Topiramate
16286171|NCT00745251|Drug|placebo|placebo
16286172|NCT00745238|Other|withdrawal of non-invasive ventilation|Four weeks withdrawal of non-invasive ventilation
16286173|NCT00745225|Drug|Pioglitazone|pioglitazone 15mg daily for 12 weeks, then 30mg daily for 84 weeks
16286174|NCT00745225|Drug|placebo comparator|1 capsule daily, 96 weeks.
16286175|NCT00745199|Drug|cromolyn sodium|oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
16286176|NCT00745199|Drug|placebo|capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
16286177|NCT00745186|Drug|Glucagen|0.2 mg or 1 mg Glucagen single injection
16286178|NCT00745186|Drug|Mayne Glucagon|0.2 mg or 1 mg Mayne Glucagon
16286179|NCT00745173|Drug|Premarin|
16286180|NCT00745160|Other|blood sample and questionnaire|After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.
16286181|NCT00745147|Drug|Chinese herbal formula (CCH1)|initial dose of 1.5/3.0/4.5gm herbal powder with 15/30/45ml placebo of duphalac, respectively, per day for mild/moderate/severe constipation, then titrated
16286182|NCT00745147|Drug|Duphalac|initial dose of 15/30/45ml duphalac with 1.5/3.0/4.5gm placebo of herbal powder, respectively, per day for mild/moderate/severe constipation, then titrated
16286183|NCT00745134|Drug|Capecitabine|Given PO
16286184|NCT00745134|Dietary Supplement|Curcumin|Given PO
16286185|NCT00745134|Other|Laboratory Biomarker Analysis|Correlative studies
16286186|NCT00745134|Other|Pharmacological Study|Optional correlative studies
16286187|NCT00745134|Other|Placebo|Given PO
16286188|NCT00745134|Other|Quality-of-Life Assessment|Ancillary studies
16286189|NCT00745134|Radiation|Radiation Therapy|Undergo radiation therapy
16286190|NCT00745121|Device|OsseoSpeed™|ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm
16286191|NCT00745108|Drug|tibolone|oral 1.25 mg tablet, once daily, for 2 years
16286192|NCT00745108|Drug|Tibolone 2.5 mg|oral 2.5 mg tablet, once daily, for 2 years
16286193|NCT00745108|Drug|CE/MPA|oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years
16286194|NCT00745095|Drug|Neostigmine|Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
16286195|NCT00745069|Drug|tapentadol HCl|
16286196|NCT00745043|Drug|bronchodilator response|
16286197|NCT00745030|Drug|Rozerem|Subjects take 1 8mg tablet 30 minutes before bedtime everyday for 8 weeks.
16286198|NCT00745030|Drug|Placebo|Placebo 8 mg tablets
16286199|NCT00745017|Behavioral|Cognitive Behavioral Therapy|All patients randomized to this condition will receive 16 consecutive weeks of manualized cognitive-behaviour therapy provided by either M.S.W or Ph.D. psychotherapists trained and certified in CBT. Treatment will be conducted according to the manualized CBT treatment for depression outlined by Beck and colleagues (Beck et al., 1979), and consistent with the protocol administered in the NIMH study.
16286200|NCT00745017|Behavioral|Interpersonal Therapy|All patients randomized to this condition will receive 16 consecutive weeks of manualized interpersonal psychotherapy conducted by M.S.W., Ph.D., or M.Ed. psychotherapists trained and certified in IPT.
16286340|NCT00743977|Drug|Phenazopyridine HCl|100mg tablet in fasting state
16286341|NCT00743964|Drug|Epirubicin|Epirubicin 50 mg/m2 iv on day 1
16286201|NCT00745017|Drug|Antidepressant medication|Patients patients randomized to this condition will be treated for 16 weeks with different classes of anti-depressant medications, using standardized protocols. Patients will receive 16 weeks of treatment with either a SSRI (sertraline or paroxetine) or a SNRI (venlafaxine). The dose range is as follows: sertraline 50-200 mg/day, paroxetine 20-40 mg/day, venlafaxine 75-375 mg/day. Patients unable to continue with the prescribed medication due to side effects and/or lack of response will be prescribed an alternate medication during the first two weeks of the protocol.
16286202|NCT00745004|Drug|Ondansetron|Over-encapsulated 4mg ondansetron tablets. Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days. For 5 weeks.
16286203|NCT00745004|Drug|Placebo|Capsule matching over-encapsulated experimental drug. 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days. For 5 weeks.
16286204|NCT00744991|Drug|Enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression
16286205|NCT00744978|Drug|Varenicline|0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks
16286206|NCT00744978|Drug|Placebo|Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
16286207|NCT00744965|Drug|Glyburide|Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
16286208|NCT00744965|Drug|Placebo|Sham dose adjustments of the placebo will be made.
16286209|NCT00744939|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop
16286210|NCT00744926|Drug|placebo|sc, once weekly
16286211|NCT00744926|Drug|taspoglutide|10mg sc, once weekly
16286212|NCT00744926|Drug|taspoglutide|20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
16286213|NCT00744913|Drug|Nicoderm patches|Women in this group will receive standard counselling and NRT (Nicoderm patches) starting with a dose of 14 mg/day that can be increased to 21 mg/day based on response (smoking cessation) and potential side effects
16286214|NCT00744913|Other|Counselling|Women in this arm of the study will receive standard counseling only.
16286215|NCT00744900|Drug|Pemetrexed, cisplatin|Alimta 500mg/m² IV 10 min infusion and Cisplatin 75mg/m² IV 60 min on day 1. Cycle will be repeated each 21 days.Folic acid orally 400µg should begin 5-7days prior to the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. Vitamin B12 will be administered as a 1000 mg intramuscular injection, approximately one week before Day 1 of cycle 1 and should repeat approximately every 9 weeks Dexamethasone, 4 mg or equivalent, should be taken orally twice per day on the day before, the day of, and the day after each dose of pemetrexed.WBRT will be administered with high energy photons systematically after cycle 6 or in case of stable disease (SD) after cycle 4 or progressive disease (PD) at any time. The dose will be 3Gy by fraction, 1 fraction per day, for 10 days.
16286216|NCT00744887|Drug|Darunavir|
16286217|NCT00744874|Procedure|RF Ablation procedure|Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
16286218|NCT00744861|Device|Exospine sham|Inactive Exospine LIPUS device (dual transducers)
16286219|NCT00744861|Device|Exospine|Active Exospine LIPUS device (dual transducers)
16286220|NCT00744861|Device|Exogen 4000+|Active Exogen LIPUS device (single transducer)
16286221|NCT00744861|Device|Exogen 4000+ sham|Inactive Exogen 4000+ LIPUS device (single transducer)
16286222|NCT00744848|Drug|Bupivacaine HCl|100 mg Bupivacaine HCl
16286223|NCT00744848|Drug|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume
16286224|NCT00744835|Procedure|Ablation procedure and/or cardioversion|Ablation Frontiers Cardiac Ablation System
16286225|NCT00744809|Drug|TMC278; Moxifloxacin; Efavirenz|
16286226|NCT00744796|Procedure|DSAEK|Endothelial Keratoplasty
16286227|NCT00744796|Diagnostic Test|Anterior Segment Optical Coherence Topography (OCT)|Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye.
16286228|NCT00744796|Diagnostic Test|Best Spectacle Corrected Visual Acuity (BSCVA)|Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances.
16286229|NCT00744770|Drug|TMC278|
16286230|NCT00744757|Drug|Decitabine|Decitabine 20 mg per m^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
16286231|NCT00744744|Other|informational intervention|Patient educational information
16286232|NCT00744744|Other|questionnaire administration|Survey
16286233|NCT00744744|Procedure|management of therapy complications|Survey
16286234|NCT00744744|Procedure|psychosocial assessment and care|Survey
16286235|NCT00744744|Procedure|quality-of-life assessment|Survey
16286236|NCT00744731|Drug|placebo|placebo for 1 week
16286237|NCT00744731|Drug|carisbamate|400 mg/day to 1,200 mg per day
16286238|NCT00744718|Drug|Bevacizumab|Bevacizumab 10 mg/kg every 3 weeks
16286239|NCT00744718|Drug|Carboplatin|Carboplatin AUC 5 every 5 weeks
16286240|NCT00744692|Biological|Unrelated Umbilical Cord Blood Transplant|Reduced Intensity Conditioning for unrelated umbilical cord blood transplant
16286241|NCT00744692|Drug|Reduced Intensity Conditioning|
16286242|NCT00744679|Drug|Natalizumab|Participants continue to receive regularly-scheduled doses of Tysabri (300 mg infusion every 28±7 days) through the Tysabri Outreach: United Commitment to Health Prescribing Program (TOUCH) throughout the screening and assessment periods. Participants must continue to be dosed every 28±7 days in order to maintain steady-state pharmacokinetics.
16286243|NCT00744666|Drug|Prednisolone 1% topical eye drops|Prednisolone 1% 1gtt qid to the eye requiring IVTA
16286244|NCT00744653|Procedure|Electrochemotherapy|Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.
16286245|NCT00744640|Drug|gemcitabine, oxaliplatin, capecitabine|gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks
16286246|NCT00744627|Drug|Vortioxetine|Encapsulated vortioxetine immediate-release tablets.
16286247|NCT00744627|Drug|Placebo|Vortioxetine placebo-matching capsules
16286250|NCT00744549|Dietary Supplement|Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E|Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
16286251|NCT00744549|Drug|Placebo|Twice a day with meals.
16286252|NCT00744536|Drug|Lenalidomide and melphalan|Lenalidomide (Revlimid) 10 mg po daily for 21d/28 Melphalan (Melphalan) 2 mg po daily for 21d/28
16286253|NCT00744523|Device|Mo.Ma cerebral protection device|Proximal embolic protection based on the principle endovascular clamping consisting of a catheter with two compliant balloons. Mo.Ma is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the CCA and distal balloon occlusion of the ECA. Cerebral protection is established prior to the initial wire passage through the stenosis and maintained during the entire procedure. Mo.Ma provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.
16286254|NCT00744510|Other|Reflexology|10 weekly sessions of 45 minutes each
16286255|NCT00744497|Drug|Placebo|
16286256|NCT00744497|Drug|Dasatinib|
16286257|NCT00744497|Drug|Docetaxel|
16286258|NCT00744497|Drug|Prednisone|
16286259|NCT00744484|Behavioral|Training in water|45 minutes interval training in water, submaximal intensity, twice a week
16286260|NCT00744484|Behavioral|Training on land|45 minutes interval training on land, submaximal intensity, twice a week
16286261|NCT00744471|Biological|tanezumab|Tanezumab 10 mg IV every 8 weeks
16286262|NCT00744471|Biological|tanezumab|Tanezumab 5mg IV every 8 weeks
16286263|NCT00744471|Biological|tanezumab|Tanezumab 2.5 mg IV every 8 weeks.
16286264|NCT00744471|Biological|Placebo|Placebo to match tanezumab IV every 8 weeks
16286265|NCT00744458|Other|Treatment contract|Patients signs in for a agreement - to respect a regular follow-up at the health facility.
16286266|NCT00744458|Other|Tracing and recall at home by a community worker|The local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits.
16286267|NCT00744458|Other|Incentive|Incentive by giving free treatment after a 4-month regular follow-up
16286268|NCT00744445|Drug|r-HuEPO|r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.
16286269|NCT00744419|Drug|pantoprazole|Intravenous pantoprazole will be administered daiy for 6 (+/- 1 day). The first 6 subjects in each age group will receive low dose [0.4 mg/kg (< 44 wks PMA) or 0.8 mg/kg (44 wks to < 1 yr)] and the last 6 subjects in each age group will receive high dose [0.8 mg/kg(< 44 wks PMA) or 1.6 mg/kg(44 wks to < 1 yr)]
16286270|NCT00744406|Behavioral|Cognitive Behavioral Therapy|All patients randomized to this condition will receive 16 consecutive weeks of manualized cognitive-behaviour therapy provided by either M.S.W or Ph.D. psychotherapists trained and certified in CBT. Treatment will be conducted according to the manualized CBT treatment for depression outlined by Beck and colleagues (Beck et al., 1979), and consistent with the protocol administered in the NIMH study.
16286271|NCT00744406|Behavioral|Interpersonal Therapy|All patients randomized to this condition will receive 16 consecutive weeks of manualized interpersonal psychotherapy conducted by M.S.W., Ph.D., or M.Ed. psychotherapists trained and certified in IPT.
16286272|NCT00744406|Drug|Antidepressant medication (sertraline ,paroxetineor or venlafaxine)|Patients patients randomized to this condition will be treated for 16 weeks with different classes of anti-depressant medications, using standardized protocols. Patients will receive 16 weeks of treatment with either a SSRI (sertraline or paroxetine) or a SNRI (venlafaxine). The dose range is as follows: sertraline 50-200 mg/day, paroxetine 20-40 mg/day, venlafaxine 75-375 mg/day. Patients unable to continue with the prescribed medication due to side effects and/or lack of response will be prescribed an alternate medication during the first two weeks of the protocol.
16286273|NCT00744393|Drug|sodium oxybate|The dose of sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and crossed over the next day
16286274|NCT00744393|Drug|placebo|The dose of placebo sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and then crossed over the next day
16286275|NCT00744380|Drug|Midazolam|Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
16286276|NCT00744380|Drug|Dexmedetomidine|Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
16286277|NCT00744367|Drug|metformin|>1500 mg/day or maximum tolerated dose (MTD)
16286278|NCT00744367|Drug|pioglitazone|>= 30 mg/day
16286279|NCT00744367|Drug|placebo|sc once weekly
16286280|NCT00744367|Drug|taspoglutide|10 mg sc once weekly;
16286281|NCT00744367|Drug|taspoglutide|20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
16286282|NCT00744354|Drug|bortezomib|Intravenous Push 1.3 mg/m2 Days 1, 4, 8, and 11
16286283|NCT00744354|Drug|pegylated liposomal doxorubicin hydrochloride|Intravenous infusion, 30mg/m2, Day 4, each cycle
16286284|NCT00744354|Drug|vorinostat|Oral, 300mg, Days 1, 2, 4, 5, 8, 9, 11, 12, every cycle.
16286285|NCT00744341|Drug|SLV320|1.25mg i.v. bid
16286286|NCT00744341|Drug|SLV320|3.75mg i.v. bid
16286287|NCT00744341|Drug|SLV320|7.5mg i.v. bid
16286288|NCT00744341|Drug|SLV320|15.0mg i.v. bid
16286289|NCT00744341|Drug|Placebo|
16286290|NCT00744328|Drug|Transdermal Estradiol|Estradiol patch ranging in dose from 50 to 200 mcg/day
16286291|NCT00744328|Drug|Sertraline|Sertraline dose will range from 50 - 200 mg/day
16286292|NCT00744328|Other|Placebo|Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
16286342|NCT00743964|Drug|Cisplatin, capecitabine|Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
16286379|NCT00743704|Other|ozoneexposure|subjects will be exposed to either ozone (250 ppb) or filtered air in an ozone challenge chamber for three hours. Ventilation will be increased to 20 l/min/m2 by intermittent exercise on a bicycle ergometer.
16286293|NCT00744315|Procedure|Mini-thoracotomy for intramyocardial injection of VEGF165|Patients with previous diagnosis of ischemic cardiopathy were included. The patient must accept and agree to be subject of clinical observation with current optimal treatment for at least 6 months. Following to that, subject undergoes intervention, in addition to consultation and assessments. Surgical technique -Ten injections VEGF165 will be made through a 25F butterfly needle in any ischemic territory where previously identified through scintigraphy. Dosis: 2.000 mg of VEGF165 in 5ml of saline solution. After the procedure, the patients will be kept in a recovery room for about 24hs and in the hospital until full clinical recovery.
16286294|NCT00744302|Drug|physiological (1.25 mmol/L ) calcium dialysate|Using the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
16286295|NCT00744289|Other|Incentive condition|Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine
16286296|NCT00744276|Drug|danazol|danazol applied topically once per day for 4 treatment cycles
16286297|NCT00744276|Drug|Placebo|placebo topically applied once daily for 4 treatment cycles
16286298|NCT00744263|Biological|VACCINE: placebo|0.5 mL, single intra-muscular injection
16286299|NCT00744263|Biological|VACCINE: 13-valent pneumococcal conjugate vaccine|0.5 mL, single intra-muscular injection
16286300|NCT00744250|Drug|Pancrelipase|PANCRECARB MS-16
16286301|NCT00744237|Drug|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration"
16286302|NCT00744237|Drug|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration"
16286303|NCT00744237|Drug|HCTZ|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration"
16286304|NCT00744224|Drug|Placebo|Single dose of placebo with saline infusion
16286305|NCT00744224|Drug|Prednisolone|Single dose of 80 mg prednisolone with saline infusion
16286306|NCT00744224|Drug|Prednisolone and Exenatide|Prednisolone 80 mg single dose Exenatide infusion 20 mg/min
16286307|NCT00744211|Drug|1mg/kg sitaxsentan sodium|1mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.
16286308|NCT00744211|Drug|2mg/kg sitaxsentan sodium|2mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.
16286309|NCT00744211|Other|Vehicle|Intravenous bolus performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass.
16286310|NCT00744198|Procedure|Autologous transobturator tape procedure|A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles
16286311|NCT00744198|Procedure|Synthetic transobturator tape procedure|Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.
16286312|NCT00744198|Procedure|Biological transobturator tape procedure|Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle
16286313|NCT00744185|Drug|propranolol treatment|30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
16286314|NCT00744185|Drug|placebo treatment|30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
16286315|NCT00744172|Procedure|laparoscopy|laparoscopic hysterectomy
16286316|NCT00744172|Procedure|vaginal|vaginal hysterectomy
16286317|NCT00744172|Procedure|abdominal|abdominal hysterectomy
16286318|NCT00744146|Biological|Protexia|Single 50 mg IM dose
16286319|NCT00744146|Biological|Protexia|Single 100 mg dose
16286320|NCT00744146|Biological|Protexia|Two 250 mg doses, IM, one at Day 1 and one at Day 72
16286321|NCT00744146|Biological|Protexia|Single 500 mg dose, IM
16286322|NCT00744146|Biological|Protexia|Single 750 mg dose, IM
16286323|NCT00744133|Biological|NF54 P. falciparum isolate|1, 3, 5 or N bites from aseptically-raised Anopheles stephensi female mosquitoes infected with Plasmodium falciparum parasites of the NF54 strain.
16286324|NCT00744107|Device|PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System|stent placement, single-arm study
16286325|NCT00744094|Dietary Supplement|protein drink|250 ml protein hydrolysate solution
16286326|NCT00744094|Behavioral|Resistance training|12 weeks resistance training, 3 days per week
16286327|NCT00744081|Drug|Glivec|
16286328|NCT00744081|Drug|Mitoxantrone|
16286329|NCT00744081|Drug|Topotecan|
16286330|NCT00744081|Drug|AraC|
16286331|NCT00744068|Behavioral|Continuing Care Telephone Support|Counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program.
16286332|NCT00744055|Drug|Prazosin|prazosin (16mg/day) 2 times a day
16286333|NCT00744055|Drug|Placebo|Placebo
16286334|NCT00744042|Biological|asfotase alfa|
16286335|NCT00744029|Behavioral|educational material|Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.
16286336|NCT00744016|Drug|Granulated mesalamine|0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning
16286337|NCT00744016|Drug|Placebo|Matching placebo capsules (4 capsules) were administered orally QD, in the morning
16286338|NCT00743990|Other|Ointment containing camphor, eucalyptus oil, and menthol|One time use
16286339|NCT00743990|Other|Petroleum jelly|One time use
16286343|NCT00743951|Behavioral|1 Patient decision aid|"Patients will receive:
~i)patient education booklet ii) a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005.
~iii) a personal decision form is an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process.
~iv) Referral to the surgeon with a standardized report of their clinical findings plus decisional data (knowledge, values, preference)."
16286344|NCT00743951|Behavioral|2 Usual care|"Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans.
~ii) Referral to the surgeon with a standardized report of their clinical findings."
16286345|NCT00743938|Drug|BMS-690514|Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
16286346|NCT00743938|Drug|Erlotinib|Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
16286347|NCT00743925|Drug|Varespladib Methyl (A-002)|2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).
16286348|NCT00743912|Drug|rifaximin|550 mg TID
16286349|NCT00743899|Procedure|The aggressive group|Stents were implanted in lesions with diameter stenosis >50% and RD ≥2.25 mm and balloon angioplasty was performed in lesions with diameter stenosis >50% and RD ≥2.0 mm and <2.25 mm.
16286350|NCT00743899|Procedure|The conservative group|Stenting was performed only in lesions with diameter stenosis >70% and reference diameter (RD) ≥2.25 mm
16286351|NCT00743886|Biological|Plasma Rich in Growth Factors (PRGF)|injection onto injured area in ligament dose: 3-6mg
16286352|NCT00743886|Drug|saline|injection of 6 cc of saline into injured area
16286353|NCT00743873|Biological|Plasma Rich in Growth Factors (PRGF)|US guided IM injection 3-6mg
16286354|NCT00743873|Drug|placebo|injection of 6 cc of saline into injured area
16286355|NCT00743860|Drug|darapladib|experimental drug
16286356|NCT00743847|Drug|placebo|Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.
16286357|NCT00743847|Drug|varenicline|Subjects randomized to the 0.5 mg arm will be titrated to the full dose during the first week in the following manner: 0.5mg QD x 7 days, then 0.5mg BID for the remainder of the 6 week trial.
16286358|NCT00743847|Drug|varenicline|Subjects randomized to the 1mg arm will be titrated to the full dose during the first week in the following manner: 0.5mg QD x 3 days, 0.5mg BID x 4 days, then 1mg BID for the remainder of the 6 week trial.
16286359|NCT00743834|Drug|Luvox CR|In light of the Luvox-CR dosing procedure of Hollander et al (2003) (50 mg increments weekly) and the available dose capsules of Luvox-CR (100 mg and 150 mg), the Luvox-CR dose will be increased over the first 6 weeks of treatment as tolerated in 50 mg to 100-mg increments every week, as tolerated and clinically indicated, to a bedtime dose between 100 and 300 mg/day. The dose will then be held constant for the duration of the study
16286360|NCT00743834|Behavioral|Behavioral Therapy|The web-based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly email feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm.
16286361|NCT00743808|Other|quality improvement|3-phase quality improvement intervention
16286362|NCT00743795|Drug|placebo|oral BID
16286363|NCT00743795|Drug|GS-9190|40 mg oral BID
16286364|NCT00743795|Drug|Peginterferon Alfa 2a|All subjects received a fixed dose of 180 μg PEG via subcutaneous injection on a weekly basis.
16286365|NCT00743795|Drug|Ribavirin|Ribavirin supplied as 200 mg Copegus® tablets (1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing ≥ 75 kg) were given in a divided daily dose.
16286366|NCT00743782|Drug|Synthetic Human Parathyroid Hormone 1-34|
16286367|NCT00743769|Drug|thymosin beta 4|Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4
16286368|NCT00743769|Other|Placebo|Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4
16286369|NCT00743756|Dietary Supplement|home-delivered meals|3 diabetic meals per day, 7 days per week for 12 months
16286370|NCT00743756|Dietary Supplement|home-delivered meals|diabetic meals 3 times per day, 7 days a week for six months
16286371|NCT00743756|Behavioral|diabetes education for 12 months|subjects in this group received diabetes education for 12 months
16286372|NCT00743743|Dietary Supplement|Longevinex brand resveratrol supplement|1 capsule daily for 52 weeks containing 215 mg of resveratrol active ingredient
16286373|NCT00743743|Dietary Supplement|placebo|1 capsule of placebo daily for 52 weeks
16286374|NCT00743730|Other|Pain and standard side effect management for PNCA with basal method.|"Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
16286375|NCT00743730|Other|Pain and standard side effect management with PNCA without basal|"Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
16286376|NCT00743730|Other|Pain and standard side effect management with IV on an as needed basis method.|"Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.
~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
16286377|NCT00743717|Device|zirconia femoral component|total knee arthroplasty performed using implant with zirconia femoral component
16286378|NCT00743717|Device|cobalt chrome femoral component|total knee arthroplasty performed using implant with cobalt chrome femoral component
16286380|NCT00743691|Other|Community Based|In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics
16286382|NCT00743652|Biological|13-valent Pneumococcal Conjugate Vaccine|4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
16286383|NCT00743652|Biological|13-valent Pneumococcal Conjugate Vaccine|3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
16286384|NCT00743652|Biological|13-valent Pneumococcal Conjugate Vaccine|2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
16286385|NCT00743652|Biological|13-valent Pneumococcal Conjugate Vaccine|2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
16286386|NCT00743652|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
16286387|NCT00743639|Procedure|intramyocardial bone marrow stem cells implantation|"Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months.
~Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10[7] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days."
16286388|NCT00743626|Other|Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)|If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)
16286389|NCT00743613|Behavioral|Sexual Health Inventory for Men (SHIM)|Five question test with maximum score of 25 points administered on the initial visit. Erectile dysfunction is indirectly related to the score.
16286390|NCT00743613|Procedure|Ankle-Brachial Index (ABI)|Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.
16286391|NCT00743600|Other|ultrasound of painful shoulder|Patients who have a shoulder that is painful or has limited movement who were referred to Radiology will have an ultrasound exam of their shoulder.
16286392|NCT00743600|Other|ultrasound|Healthy volunteers who do not have pain or limited movement will have an ultrasound exam of their shoulder.
16286393|NCT00743587|Drug|Placebo|Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
16286394|NCT00743587|Drug|Oxycodone|Oral, 1 x 20mg controlled-release tablets
16286395|NCT00743587|Drug|Tramadol|Oral, 2 x 50mg immediate release capsules
16286396|NCT00743587|Drug|Naproxen|Oral, 1 x 500mg enteric-coated
16286397|NCT00743574|Dietary Supplement|Vitamin D2 (Ergocalciferol)|50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
16286398|NCT00743574|Drug|Medroxyprogesterone (Provera)|10mg, PO, daily for ten days
16286399|NCT00743574|Dietary Supplement|Vitamin D3 (Cholecalciferol)|2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
16286400|NCT00743574|Dietary Supplement|Elemental Calcium|1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
16286401|NCT00743561|Device|Polysomnography|Simultaneous recording of electro-encephalography, tibial and submental electro-myography, electro-oculography, nasal air flow, oxygen saturation, as well as the thoracic and abdominal respiratory effort
16286402|NCT00743561|Device|ambulatory polygraphy|Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.
16286403|NCT00743548|Device|IB = Interdental brush, the intervention|IB is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth. The IB is inserted once and removed.
16286404|NCT00743548|Device|DF = Dental floss, the positive control|DF is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth. DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.
16286405|NCT00743535|Procedure|Transobturatory correction of anterior defect plus TOT|"Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage.
~Small incision sites in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of mono-use needle"
16286406|NCT00743535|Procedure|Transobturatory correction of anterior defect plus TVT|"Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage.
~Small incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle."
16286407|NCT00743522|Device|ICD/ CRT-D|Cardiac device
16286408|NCT00743509|Drug|Cyclophosphamide and Sirolimus|"The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
16286409|NCT00743496|Biological|Anti-GD2 antibody|Anti-GD2 antibody
16286410|NCT00743483|Drug|rhBSSL|oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
16286411|NCT00743470|Drug|lopinavir/ritonavir|lopinavir/ritonavir tablet; see arm for intervention description
16286412|NCT00743470|Drug|rifabutin|rifabutin capsule; see arms for intervention description
16286413|NCT00743457|Device|Ocular Ultrasound|B-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath
16286414|NCT00743444|Drug|AZD3355|65 mg capsules, oral, 3 single doses
16286415|NCT00743444|Drug|Placebo|capsules, oral, 3 single doses
16286416|NCT00743431|Drug|Caelyx (Pegylated Lyposomal Doxorubicin)|Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
16286417|NCT00743418|Device|GPS modem and RFID|The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.
16286418|NCT00743405|Drug|GSK1034702|Oral or liquid
16286420|NCT00743379|Drug|TH-302|TH-302 will be administered by IV infusion over 30 minutes on Days 1, 8 and 15 of a 28- day cycle for Arm A and on Days 1 and 8 of a 21 day cycle for Arms B and C.
16286421|NCT00743366|Drug|Marijuana|0,6.2% THC
16286422|NCT00743366|Drug|Quetiapine|200 mg/day
16286423|NCT00743366|Drug|Placebo oral capsule|
16286424|NCT00743353|Drug|F-18 RGD-K5|Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up
16286425|NCT00743340|Drug|Emtricitabine|6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
16286426|NCT00743327|Drug|Pioglitazone|45mg capsule, once daily for 1 year
16286427|NCT00743314|Other|screening questionnaire administration|
16286428|NCT00743314|Procedure|computed tomography|
16286429|NCT00743314|Procedure|lymphoscintigraphy|
16286430|NCT00743314|Procedure|single photon emission computed tomography|
16286431|NCT00743314|Radiation|intensity-modulated radiation therapy|
16286432|NCT00743314|Radiation|technetium Tc 99m sulfur colloid|
16286433|NCT00743301|Other|Palm olein vs olive oil and lard|17E% from test fat is incorporated into three rolls and a piece of cake
16286434|NCT00743288|Drug|Melphalan|Same as above
16286435|NCT00743288|Drug|Panobinostat|
16286436|NCT00743275|Biological|Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)|0.5 mL, intramuscular
16286437|NCT00743262|Device|Provox voice prosthesis|The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted
16286438|NCT00743249|Device|MINI MONOKA canalicular stent, 10 mm|40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
16286439|NCT00743249|Device|MINI MONOKA canalicular stent, 20 mm|40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length
16286440|NCT00743236|Procedure|cold ischemia procedure|Cold ischemia followed by partial nephrectomy
16286441|NCT00743236|Procedure|warm ischemia procedure|Warm ischemia followed by partial nephrectomy
16286442|NCT00743223|Other|The measure of the cervical posture|The investigation of the cervical position consisted of locating the individual in side view with the parallel feet in erect position and tracing an imprisoned plumb wire to the ceiling and tangent to the kyphosis curve of the thoracic column. With a ruler it was verified at a distance of this line until the point deepest of the cervical lordosis curve.
16286443|NCT00743210|Drug|L-citrulline|Oral L-citrulline, 3 grams once per day for 3 weeks.
16286444|NCT00743210|Drug|Placebo|Placebo, 3 grams once per day for 3 weeks.
16286445|NCT00743197|Drug|Aspirin|Aspirin 81 mg daily
16286446|NCT00743197|Drug|Lisinopril|Lisinopril 10 mg every night
16286447|NCT00743197|Drug|Simvastatin|Simvastatin 20 mg every night
16286448|NCT00743197|Drug|Lovaza|Lovaza 1 gram daily
16286449|NCT00743197|Behavioral|Therapeutic Lifestyle Changes|Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.
16286452|NCT00743145|Drug|Inactive Marijuana (0% THC)|Marijuana cigarette containing 0% THC
16286453|NCT00743145|Drug|Active Marijuana (5.5% THC)|Marijuana cigarette containing 5.5% THC
16286454|NCT00743145|Drug|Active Marijuana (6.2% THC)|Marijuana cigarette containing 6.2% THC
16286455|NCT00743145|Drug|Naltrexone|Naltrexone (12mg/70kg)
16286456|NCT00743145|Drug|Placebo naltrexone|Naltrexone (0mg)
16286457|NCT00743119|Drug|Placebo capsules|Placebo capsules
16286458|NCT00743119|Drug|Inactive marijuana (0% THC)|Inactive marijuana cigarettes (0% THC) provided by NIDA
16286459|NCT00743119|Drug|Low dose Dronabinol|Dronabinol 10mg
16286460|NCT00743119|Drug|High dose Dronabinol|Dronabinol 20mg
16286461|NCT00743119|Drug|Low THC marijuana|marijuana cigarettes (1.98% THC) provided by NIDA
16286462|NCT00743119|Drug|High THC marijuana|Marijuana cigarettes (3.56% THC) provided by NIDA
16286463|NCT00743106|Drug|Fenoldopam|Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
16286464|NCT00743106|Drug|Placebo|Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery
16286465|NCT00743093|Drug|acetaminophen|500 mg caplets; 2 caplets (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.
16286466|NCT00743093|Drug|placebo|placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days
16286467|NCT00743080|Procedure|Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX|"Laparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX).
~Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation."
16286468|NCT00743080|Procedure|Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1|"Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1).
~Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation."
16286469|NCT00743067|Drug|GSK1363089 (formerly XL880)|GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally
16286470|NCT00743041|Behavioral|Emotional Freedom Techniques (EFT)|EFT is an exposure therapy with a cognitive component, consisting of recall of a trauma along with a statement of self-acceptance, in combination with touching or tapping on a series of stress reduction points on the body
16286471|NCT00743028|Drug|ABT-263|Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation
16286472|NCT00743028|Drug|ABT-263|Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.
16286473|NCT00743028|Drug|ABT-263|Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.
16286474|NCT00743015|Drug|BI 44370 TA tablet|
16286475|NCT00743002|Drug|TT223 with Metformin and/or TZD|Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
16286476|NCT00743002|Drug|Placebo with Metformin and/or TZD|Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
16286477|NCT00742989|Other|OLT maneuver|direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds
16286478|NCT00742989|Other|Sham OLT|Therapeutic massage performed
16286479|NCT00742976|Drug|Insulin Detemir; Insulin Insulatard|Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.
16286480|NCT00742976|Drug|Insulin Detemir, Insulin Insulatard|Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
16286481|NCT00742963|Drug|TH-302|"TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
~Dose escalation dose levels:
~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
16286482|NCT00742950|Procedure|Nasal 2.8-mm corneal incision|Phacoemulsification through a nasal 2.8-mm incision
16286483|NCT00742950|Procedure|Temporal 2.8-mm corneal incision|Phacoemulsification through a 2.8-mm temporal incision
16286484|NCT00742950|Procedure|Superior 2.8-mm incision|Phacoemulsification through a superior 2.8-mm corneal incision
16286485|NCT00742937|Dietary Supplement|vitamin A|second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.
16286486|NCT00742937|Dietary Supplement|Placebo|second capsule with vitamin E, eight days after delivery.
16286487|NCT00742924|Drug|cisplatin|Given IV
16286488|NCT00742924|Drug|dexrazoxane hydrochloride|Given IV
16286489|NCT00742924|Drug|doxorubicin hydrochloride|Given IV
16286490|NCT00742924|Drug|etoposide|Given IV
16286491|NCT00742924|Drug|ifosfamide|Given IV
16286492|NCT00742924|Drug|leucovorin calcium|Given IV or orally
16286493|NCT00742924|Drug|methotrexate|Given IV
16286494|NCT00742924|Drug|zoledronic acid|Given IV
16286495|NCT00742924|Procedure|adjuvant therapy|
16286496|NCT00742924|Procedure|neoadjuvant therapy|
16286497|NCT00742924|Procedure|therapeutic conventional surgery|Surgery of the primary tumor is scheduled for 12 weeks after the commencement of chemotherapy.
16286498|NCT00742924|Biological|filgrastim|Given SC
16286499|NCT00742924|Drug|Mesna|Given IV
16286500|NCT00742911|Drug|Disulfiram|"Patients will take a pill of disulfiram at a fixed dose of 250 mg with their evening meal. This dose of disulfiram used to treat alcoholism. We will start by administering 2 mg of copper as copper gluconate along with 250 mg disulfiram.
~Patients must not consume beverages containing alcohol while taking disulfiram."
16286501|NCT00742911|Drug|Copper Gluconate|"Commercially available. Copper gluconate has long been manufactured and sold as a food supplement. Copper gluconate should be taken separately from disulfiram, and if possible with breakfast.
~Copper gluconate should not be administered to individuals with Wilson's disease or a family history of Wilson's disease.
~Patients will receive 2 mg, 4mg, 6mg or 8mg daily"
16286502|NCT00742898|Other|Non-targeted opt-out rapid HIV screening|Experimental Arm: Integrated non-targeted opt-out rapid HIV screening Active Comparator Arm: Integrated diagnostic rapid HIV testing
16286503|NCT00742885|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted|All subjects will receive 2 doses administered as an intramuscular (IM) injection.
16286504|NCT00742872|Drug|Mosapride Citrate|One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
16286505|NCT00742872|Drug|Placebo|One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.
16286506|NCT00742859|Drug|betrixaban|orally, once daily for at least 3 months
16286507|NCT00742859|Drug|Warfarin|Warfarin will be prescribed by the investigator according to the standard of care.
16286508|NCT00742846|Drug|Lidocaine + Kenalog|"5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint
~Intra-articular injection with local anesthetic and steroid"
16286509|NCT00742846|Drug|Lidocaine + Kenalog|"5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space
~Local anesthetic and steroid in to the subacromial space"
16286510|NCT00742846|Drug|Lidocaine|"5ml 1% Lidocaine alone into the shoulder joint.
~intra-articular local anesthetic injection"
16286511|NCT00742846|Drug|Lidocaine|"5ml 1% Lidocaine alone into the subacromial space.
~subacromial local anesthetic injection"
16286512|NCT00742833|Drug|KUC-7483|
16286513|NCT00742833|Drug|Placebo|
16286514|NCT00742820|Drug|Calcium Acetate Oral Solution 667 mg per 5 mL|Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
16286591|NCT00742274|Device|Gore TAG Endoprosthesis|Implant Gore TAG device with Best Medical therapy per physician discretion
16286515|NCT00742820|Drug|Calcium Acetate 667 mg GelCaps|Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses.
16286516|NCT00742820|Dietary Supplement|Calcium Citrate 950 mg Caplets|Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
16286517|NCT00742807|Drug|Low dose of alfentanil hydrochloride|Administration of low dose alfentanil hydrochloride before paracervical block
16286518|NCT00742807|Drug|Normal dose of alfentanil hydrochloride|Normal dose of alfentanil hydrochloride is administered after paracervical block
16286519|NCT00742794|Other|Observation|Observation of sting frequency
16286520|NCT00742781|Dietary Supplement|Vitamin D|Oral supplementation daily with up to 5000 IU over 6 months.
16286521|NCT00742768|Dietary Supplement|Vitamin K2 in softgel|4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule
16286522|NCT00742768|Dietary Supplement|Vitamin K2 in Gelpell|4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule
16286523|NCT00742755|Behavioral|Prospective intervention|Prospective Intervention: Peer navigator who assists with appointment making, transportation, translations, completing forms, etc.
16286524|NCT00742742|Behavioral|healthy life style education|healthy life style education
16286525|NCT00742729|Behavioral|Arm 1|Educational small group session with free FOBT kit
16286526|NCT00742729|Behavioral|Arm 2|Educational small group session with no FOBT kit
16286527|NCT00742729|Behavioral|Arm 3|Educational small group session, exercise
16286528|NCT00742716|Drug|CTA018 Injection|Comparison of different dosages of drug
16286529|NCT00742703|Other|Mineralized water|
16286530|NCT00742703|Other|Low mineralized water|
16286531|NCT00742690|Drug|terlipressin given by intravenous boluses and albumin|Patients who will be randomly assigned to arm 1 will received terlipressin given by intravenous boluses at the initial dose of terlipressin was 0.5 mg/4 hr. In case of non response, the dose of terlipressin was progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.
16286532|NCT00742690|Drug|terlipressin given by continuous intravenous infusion and albumin|Patients who will be randomly assigned to arm 1 will received terlipressin given as intravenous boluses at the initial dose of 0.5 mg/4 hr. In case of non response, the dose of terlipressin will be progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given at the dose of 1 g/kg of body weight at the first day followed by 20-40 g/day.
16286533|NCT00742677|Procedure|nutritional support|Given orally
16286534|NCT00742664|Behavioral|Cognitive-behavioral therapy|The manual is informed by behavioral principles and provides a structured, replicable manner of treating OC symptoms in youth with PWS. The treatment is individual in nature, includes a strong family component (i.e., teaching parents to be their child's coach/therapist), and lasts for approximately 12 sessions, held in a twice-weekly format. In addition, the protocol includes several specific components: education about OC symptoms (i.e., etiology, behavioral function, etc.), developing a hierarchy of rituals to target, exposure and response prevention exercises, promoting adaptive familial responses to child behaviors, and relapse prevention and problem solving future situations.
16286535|NCT00742664|Behavioral|Wait-list control|The subject will not receive active treatment during this interval.
16286536|NCT00742638|Drug|Quetiapine fumarate|Investigational product: quetiapine fumarate tablet 25 mg and 200 mg
16286537|NCT00742638|Drug|Sodium valproate|Sodium valproate tablet 200 mg
16286538|NCT00742625|Drug|daunorubicin hydrochloride|Given IV
16286539|NCT00742625|Drug|cytarabine|Given IV
16286540|NCT00742625|Drug|bortezomib|Given IV
16286541|NCT00742612|Drug|ARC1779 Injection|Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The ARC1779 treatment group will be dosed to achieve a target ARC1779 steady-state plasma concentration of 3 Ug/mL, using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
16286542|NCT00742612|Drug|Placebo (normal saline)|Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The placebo group will be dosed to a steady-state plasma concentration using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
16286543|NCT00742599|Drug|NPO-11|20 ml NPO-11
16286544|NCT00742599|Drug|Placebo|20 ml NPO-11(Placebo)
16286545|NCT00742573|Drug|Antidepressants through Texas Medication Algorithm (TMA)|Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
16286546|NCT00742573|Behavioral|Brief Interpersonal Psychotherapy (IPT-B)|IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
16286547|NCT00742560|Biological|elotuzumab|Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.
16286548|NCT00742560|Drug|lenalidomide|Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle
16286549|NCT00742560|Drug|dexamethasone oral|Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)
16286550|NCT00742560|Drug|dexamethasone injection|Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)
16286551|NCT00742547|Other|Telephone counseling|Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices
16286552|NCT00742534|Drug|Intravenous L-Citrulline|This is a classic dose escalation using initial doses of 10 mg/kg of intravenous citrulline and advancing the dose by 10 mg/kg every 3 patients for a target peak plasma citrulline concentration of 100 umol/L. This regimen will be adjusted with pharmacokinetic data as it becomes available so that it may be adjusted to maintain appropriate serum levels of the urea cycle precursors and NO metabolites of interest.
16286553|NCT00742521|Procedure|glucose clamp|Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure
16286554|NCT00742521|Procedure|glucose clamp|Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
16286555|NCT00742521|Procedure|glucose clamp|Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 2 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.
16286556|NCT00742521|Procedure|glucose clamp|Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 1 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.
16286557|NCT00742508|Drug|SK&F-105517-D 10 mg capsule|1 capsule once a day
16286558|NCT00742508|Drug|Carvedilol-immediate release (IR) 2.5 mg tablet|1 or 2 tablet(s) twice a day
16286559|NCT00742508|Drug|SK&F-105517-D 20 mg capsule|1 capsule once a day
16286560|NCT00742508|Drug|SK&F-105517-D 40 mg capsule|1 or 2 capsule(s) once a day
16286561|NCT00742508|Drug|Carvedilol-IR 10 mg tablet|1 tablet twice a day
16286562|NCT00742495|Drug|Forodesine|PK study
16286563|NCT00742482|Drug|HL 10|Freeze dried HL 10
16286564|NCT00742469|Drug|Rifaximin|
16286565|NCT00742469|Drug|Placebo|
16286566|NCT00742456|Dietary Supplement|Glucose solution|single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
16286567|NCT00742456|Dietary Supplement|Placebo|single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
16286568|NCT00742443|Drug|Juvista (avotermin)|100ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure
16286569|NCT00742443|Drug|Juvista (avotermin)|250ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure
16286570|NCT00742443|Drug|Juvista (avotermin)|250ng/100µL Juvista administered to each linear centimetre of the margins of both wound segments by intradermal injection immediately after and then 24h after wound closure
16286571|NCT00742430|Procedure|PCI|percutaneous coronary intervention in stable coronary artery disease
16286572|NCT00742417|Biological|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:
~three weeks of intensive treatment with two plasma exchanges per week
~six weeks of maintenance treatment with one weekly plasma exchange
~three months of maintenance treatment with one plasma exchange every two weeks"
16286573|NCT00742417|Other|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
16286574|NCT00742404|Drug|bortezomib|
16286575|NCT00742404|Drug|dexamethasone|
16286576|NCT00742404|Drug|pegylated liposomal doxorubicin hydrochloride|
16286577|NCT00742404|Genetic|protein analysis|
16286578|NCT00742404|Other|immunologic technique|
16286579|NCT00742391|Drug|PEP005 (ingenol mebutate) Gel|two day treatment
16286580|NCT00742391|Drug|Vehicle gel|two day treatment
16286581|NCT00742365|Device|Bright light|One hour of exposure to bright light daily upon awakening for 6 weeks.
16286582|NCT00742365|Device|Red light placebo|One hour of exposure to red light.
16286583|NCT00742339|Drug|Terlipressin plus albumin|The terlipressin will be give at the initial dose of 3 mg/24 hours by intravenous continuous infusion. If during the following 48 hours the serum value of creatinine will not change or will go down less than 25%, the dose of terlipressin will be increased to 6 mg/24 hours. If no response will ensue, the dose of terlipressin will be increased to the maximal dose of 12 mg/24 hours. Twenty percent human albumin solution will be administrate together with terlipressin at the dosage of 1 g/Kg of body weight, on first day, and then, to the dosage of 20-40 g/Kg in order to maintain the central venous pressure (CVP) between 10 and 15 cm H2O.The treatment with terlipressin and albumin will be maintained for 24 hours after complete or incomplete resolution. The length of the study in patients with complete and incomplete resolution will reach a maximum of 15 days. In the patients without response the treatment with the high dosage of terlipressin will go on for a maximum of 7 days.
16286584|NCT00742339|Drug|Midodrine plus octreotide plus human albumin|Midodrine will be give orally at the initial dose 7.5 tid together with octreotide at the initial dosage of 100 µg subcutaneously tid. If during the following 96 hours the serum value of creatinine will not change or will go down less than 25%, the dose of midodrine will be increased to 12.5 mg tid Twenty percent human albumin solution will be administrate together with midodrine and octreotide at the dosage of 1 g/Kg of body weight, on first day, and then, to the dosage of 20-40 g/Kg in order to maintain the central venous pressure (CVP) between 10 and 15 cm H2O.The treatment with terlipressin and albumin will be maintained for 24 hours after complete or incomplete resolution. The length of the study in patients with complete and incomplete resolution will reach a maximum of 15 days. In the patients without response the treatment with the high dosage of terlipressin will go on for a maximum of 7 days.
16286585|NCT00742326|Drug|Pioglitazone|45 mg/daily
16286586|NCT00742326|Drug|Placebo|one capsule daily
16286587|NCT00742313|Biological|FloSeal Matrix|10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
16286588|NCT00742300|Procedure|Autologous hematopoietic stem cell transplantation|Transplantation of CD34-selected autologous hematopoietic stem cells after high-dose chemotherapy with cyclophosphamide (200mg/kg) and rabbit-antithymocyteglobulin (90mg/kg)
16286589|NCT00742287|Dietary Supplement|oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)|200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks
16286590|NCT00742287|Dietary Supplement|Placebo|placebo
16286592|NCT00742274|Other|Best Medical Therapy|Best Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators.
16286593|NCT00742261|Drug|GSK1363089|Two-part study to evlauate the relative bioavailability of GSK1363089 from a free base formulation (GSK1363089G) compared with the biophosphate salt formulation (GSK1363089A) (Part 1) and to assess the safety of the GSK1363089 biophosphate formulation when administered three times a week until disease progression (Part 2).
16286594|NCT00742248|Drug|Formoterol|pMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
16286595|NCT00742248|Drug|Formoterol|DPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
16286596|NCT00742248|Drug|Placebo|Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening
16286597|NCT00742235|Drug|ergocalciferol|Ergocalciferol 50,000 IU given every other day for 5 total doses
16286598|NCT00742222|Radiation|Electronic Brachytherapy|34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.
16286599|NCT00742222|Radiation|Intracavitary accelerated partial breast irradiation|3.4 Gy BID x 5 days
16286600|NCT00742209|Drug|GSK1838262|Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day
16286601|NCT00742209|Drug|Placebo|Placebo-control
16286602|NCT00742183|Device|Mepilex|Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
16286603|NCT00742183|Device|Silvadene|Silvadene - dressing changes every day, more frequently if needed
16286604|NCT00742170|Device|Electroacupuncture|Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification.
16286605|NCT00742157|Drug|Growth Hormone|dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
16286606|NCT00742144|Drug|ofatumumab|Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.
16286607|NCT00742131|Drug|GSK1363089|GSK1363089 will be administered orally as a cinnamon-flavored liquid (250 milligrams of GSK1363089 in 50 milliliters liquid [5 milligrams/milliliter] or 1000 milligrams of GSK1363089 in 50 milliliters liquid [20 milligrams/milliliter]) or as solid capsules of 20, 100, and/or 200 milligrams.
16286608|NCT00742118|Procedure|Colic biopsies|colic biopsies and analysis
16286609|NCT00742105|Drug|BGT226|
16286610|NCT00742092|Drug|miglustat|Oral miglustat capsules 200 mg t.i.d. (three times a day) for 7 days and a single 200 mg dose on Day 8
16286611|NCT00742092|Drug|placebo|Oral placebo capsules matching in appearance miglustat capsules given t.i.d. (three times a day) for 7 days and a single dose on Day 8
16286612|NCT00742079|Drug|D-cycloserine|Single, fixed 50-mg dose of D-cycloserine administered 1 hour prior to a CBT session
16286613|NCT00742079|Behavioral|Cognitive Behavioral Therapy|One-hour talk therapy session with a trained clinician aimed at increasing cognitive flexibility by examining alternative explanations to everyday situations
16286614|NCT00742066|Drug|Irbesartan|Single dose 600mg orally
16286615|NCT00742066|Drug|Felodipine|single dose 10mg Felodipine ER
16286616|NCT00742066|Drug|Placebo|Single dose tablet orally
16286617|NCT00742053|Device|ECG-guided PICC placement|Patients undergoing PICC placement will have ECG data collected as a function of tip location.
16286618|NCT00742040|Drug|Captopril|A rapid 3-day up-titration protocol
16286619|NCT00742040|Drug|Captopril|A slower 9-day up-titration protocol
16286620|NCT00742027|Drug|Panobinostat|Panobinostat hard gelatin capsules.
16286621|NCT00742014|Drug|Sildenafil|One oral dose of Sildenafil (0.5 mg/kg) will be administered nia a nasogastric tube
16286622|NCT00742001|Biological|Mirasol System for Whole Blood.|Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
16286623|NCT00741988|Drug|Ixabepilone|ixabepilone 30 mg/m2
16286624|NCT00741988|Drug|Carboplatin|carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
16286625|NCT00741988|Drug|Bevacizumab|bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
16286626|NCT00741975|Behavioral|Affect Management|12-session group intervention including affect management training as well as sexual health skills training
16286627|NCT00741975|Behavioral|General Health Promotion|12-session group intervention including health information on a variety of developmentally relevant health topics
16286628|NCT00741962|Dietary Supplement|VR-3 Herbal Blend|This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.
16286629|NCT00741962|Dietary Supplement|Placebo|The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.
16286630|NCT00741949|Drug|Propofol|Sedation in TCI with propofol
16286631|NCT00741949|Drug|Placebo|Isotonic saline solution infusion
16286632|NCT00741936|Drug|MaZiRenWan (MZRW)|MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily
16286633|NCT00741936|Drug|Placebo|Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily
16286634|NCT00741923|Other|navy beans added to regular diet|5 cups per week of commercially available white beans for 4-weeks
16286635|NCT00741910|Drug|Semapimod|semapimod IV 60 mg x 3 days q 6 - 10 weeks
16286636|NCT00741897|Drug|Fexofenadine|Fexofenadine: One 30 mg Tablet once daily for two weeks
16286637|NCT00741884|Drug|Varenicline Controlled Release 1.2 mg|Varenicline CR tablet 1.2 mg BID for 7 weeks
16286638|NCT00741884|Drug|Varenicline Controlled Release 1.8 mg|Varenicline CR tablet 1.8 mg BID for 7 weeks
16286639|NCT00741884|Drug|Varenicline Controlled Release 2.4 mg|Varenicline CR tablet 2.4 mg BID for 7 weeks
16286640|NCT00741884|Drug|Varenicline Immediate Release 1 mg|Varenicline IR tablet 1 mg BID for 7 weeks
16286641|NCT00741884|Drug|Placebo|Placebo BID for 7 weeks
16286642|NCT00741871|Drug|SB1518|SB1518 taken orally daily for 28 consecutive days in a 28 day cycle
16286643|NCT00741858|Procedure|Duragen duraplasty|Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
16286644|NCT00741858|Procedure|Duraguard duraplasty|Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
16286645|NCT00741845|Drug|intravaginal metronidazole|high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
16286646|NCT00741832|Device|Conical Positive Expiratory Pressure Device (C-PEP)|"Conical positive expiratory pressure device (C-PEP) in this study was designed on the principle of expiratory flow retardation. The principle occurs when exhaling through a small tube diameter, i.e. a small straw, pursed lip breathing, or positive expiratory pressure. Expiratory retardation, results from a decrease in tube diameter, creates flow resistance during exhalation. With flow resistance, the greater the flow the greater the back pressure, and the less the flow the lower the pressure. Expiratory retardation was applied in an attempt to facilitate exhalation and to relieve the air trapping.
~The optimal design was found to be: cone shape, proximal diameter is 2.0 cm, distal diameter is 0.6 cm, and length is 2.5 cm.
~Subjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing with the C-PEP device."
16286647|NCT00741832|Other|Control breathing|Subjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing normally.
16286648|NCT00741819|Drug|Inhaled treprostinil|
16286649|NCT00741806|Biological|GHB04L1|single dose intranasal administration of GHB04L1
16286650|NCT00741806|Other|Placebo|SPGN buffer
16286651|NCT00741780|Drug|Placebo|
16286652|NCT00741780|Drug|plerixafor|
16286653|NCT00741780|Drug|granulocyte colony-stimulating factor (G-CSF)|
16286654|NCT00741767|Drug|salmeterol-fluticasone|250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily
16286655|NCT00741754|Other|Mouthrinse with HcT20|Mouthrinse for 1 minute with 10ml, twice a day. During seven weeks
16286656|NCT00741741|Drug|TMC278|
16286657|NCT00741728|Other|Spider flash EKG, echocardiography tracking, step test|cardiac rhythm recorded during health check up, echocardiography tracking of the right common carotid, step test during 2 minutes
16286658|NCT00741715|Drug|AVE5530|oral administration once daily in the evening with dinner
16286659|NCT00741715|Drug|atorvastatin|oral administration once daily in the evening with dinner
16286660|NCT00741715|Drug|placebo|oral administration once daily in the evening with dinner
16286661|NCT00741702|Other|Nurse administered treatment algorithm|Start with Irbesartan 150 mg/d; check BP in 6 wks, if BP >=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP>=13/80 mm Hg, increase verapamil to 240 mg/d
16286662|NCT00741689|Drug|AZD1656|Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose
16286663|NCT00741676|Procedure|laparoscopy-assisted distal gastrectomy|10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3~5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed.
16286664|NCT00741676|Procedure|open distal gastrectomy|Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.
16286665|NCT00741663|Drug|Spironolactone and furosemide|Patients in arm A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day.
16286666|NCT00741663|Drug|Spironolactone and furosemide|Patients in arm B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.
16286667|NCT00741650|Behavioral|Information and Peer advisor|Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work.
16286668|NCT00741650|Behavioral|Information, peer advisor and fast referral|"Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work.
~In addition, the peer advisor can refer employees who do not improve to a two day educational program that also includes a medical exam and individual counselling.
~In addition,"
16286669|NCT00741637|Biological|CholeraGarde®|"Live attenuated oral Cholera vaccine
~Each vial of CholeraGarde® contains 5x107 to 1x109 CFU of Peru-15, 6.75 mg KH2PO4, and 300 mg trehalose as a lyophilized cake in 5 mL single-dose vials"
16286670|NCT00741637|Biological|Placebo|A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.
16286671|NCT00741624|Other|Bandage|one application for one week
16286672|NCT00741611|Device|HD Mesh Ablation System|Ablation using the HD Mesh Ablation System
16286673|NCT00741611|Drug|Anti-arrhythmic drugs|5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
16286674|NCT00741598|Drug|Galantamine-ER|Galantamine-ER 8 to 24 mg per day for 16 weeks
16286675|NCT00741598|Drug|Galantamine placebo|Galantamine placebo 8 to 24 mg per day for 16 weeks
16286721|NCT00741338|Drug|Cyclosporine A (CsA)|Orally three times daily.
16286676|NCT00741585|Drug|Any antihypertensive medication alone or in combination|All drugs on awakening
16286677|NCT00741585|Drug|Any antihypertensive medication alone or in combination|One or more drugs at bedtime
16286678|NCT00741585|Device|Ambulatory blood pressure monitoring|Sampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours
16286679|NCT00741559|Device|magnetoencephalography|MEG studies are performed using a whole-head Omega 151-channel gradiometer system.
16286680|NCT00741559|Device|Positron emission tomography (PET)|An interictal FDG(fluoro-D-glucose)-PET will be obtained in a single 10 minute scanning session. PET scans will be obtained using a 3D acquisition technique, which will allow the use of a lower dose of radiotracer.
16286681|NCT00741559|Device|Magnetic resonance imaging|MR will be performed on a 1.5T or 3T system, using a combination of different sequences including sagittal T1, coronal and axial T2, FLAIR and proton density and axial 3D T1 weighted images.
16286682|NCT00741546|Procedure|Cardiac Surgery|Cardiac Surgery
16286683|NCT00741520|Device|CPAP|Control - no treatment
16286684|NCT00741520|Device|CPAP|CPAP: The airway pressure will be determined by an overnight sleep study titration.
16286685|NCT00741507|Behavioral|Alcohol drinking|Never drinking of alcohol
16286686|NCT00741507|Behavioral|Alcohol drinking|"Mild drinking of alcohol assessed by alcohol use disorders identification test (AUDIT)"
16286687|NCT00741507|Behavioral|Alcohol drinking|"Moderate drinking of alcohol assessed by alcohol use disorders identification test (AUDIT)"
16286688|NCT00741507|Behavioral|Alcohol drinking|"Severe over drinking of alcohol assessed by alcohol use disorders identification test (AUDIT)"
16286689|NCT00741507|Behavioral|Alcohol drinking|"Alcohol-dependent assessed by alcohol use disorders identification test (AUDIT)"
16286690|NCT00741494|Device|PICSI dish|Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
16286691|NCT00741481|Procedure|FDG-PET imaging|FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer
16286692|NCT00741468|Drug|Proellex|2, 25 mg Proellex capsules administered daily
16286693|NCT00741468|Drug|CYP1A2 probe|Caffeine (200 mg)
16286694|NCT00741468|Drug|CYP2C9 probe|Tolbutamide (250 mg)
16286695|NCT00741468|Drug|CYP2C19 probe|Omeprazole (20 mg)
16286696|NCT00741468|Drug|CYP2D6 probe|Dextromethorphan (30 mg)
16286697|NCT00741468|Drug|CYP3A4 probe|Midazolam (2mg)
16286698|NCT00741455|Procedure|Stem Cell Transplant|"Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be > 5 x 106 CD34+cells/kg of recipient.
~Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
~Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml."
16286699|NCT00741455|Drug|G-CSF|10 mcg/kg/day on days 5, 6, and 7
16286700|NCT00741455|Drug|Fludarabine|25 mg/m2/d IV over 30 minutes on days -6 to -2
16286701|NCT00741455|Drug|cyclophosphamide|1 g/m2/d IV on days -3 and -2
16286702|NCT00741455|Drug|Cyclosporine|used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml
16286703|NCT00741455|Drug|Methotrexate|used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml
16286704|NCT00741442|Drug|RDEA806|Uricosuric agent for the treatment of gout
16286705|NCT00741442|Drug|Placebo|Matching Placebo.
16286706|NCT00741429|Drug|Technosphere Insulin Inhalation Powder|Subjects previously treated with Technosphere Insulin Inhalation Powder
16286707|NCT00741429|Drug|Comparator|Subjects previously treated with other anti-diabetic medications
16286708|NCT00741403|Drug|CPI-613|CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD) technology platform. It is selective against tumor cells (but not normal cells)according to preclinical studies
16286709|NCT00741390|Device|BD/33G|BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
16286710|NCT00741390|Device|OTM / 33G|OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
16286711|NCT00741390|Device|OTU/28G|OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ BGM) and OneTouch® Ultra® test strips)
16286712|NCT00741390|Device|ACC/28G|Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)
16286713|NCT00741390|Device|OTM/28G|OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
16286714|NCT00741377|Drug|BHQ880|
16286715|NCT00741377|Drug|Zoledronic acid|
16286716|NCT00741364|Dietary Supplement|vitamin D3 (cholecalciferol)|liquid vitamin D solution (vitamin D3 in ethanol) taken daily at one of three possible doses (400, 10000, or 40000 IU/d) for 4-6 weeks prior to radical prostatectomy
16286717|NCT00741351|Drug|Sevoflurane + Fentanyl|Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary
16286718|NCT00741351|Drug|Sevoflurane + Remifentanyl|Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary
16286719|NCT00741351|Drug|Propofol + Remifentanyl|Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary
16286720|NCT00741338|Biological|Laronidase|0.058 mg/kg - 0.58 mg/kg IV infusion weekly.
16286722|NCT00741338|Drug|Azathioprine (Aza)|Orally either every day for Cohort 1 or every other day for Cohort 2.
16286723|NCT00741325|Drug|granulocyte colony-stimulating factor (G-CSF)|
16286724|NCT00741325|Drug|plerixafor|
16286725|NCT00741325|Drug|Placebo|
16286726|NCT00741312|Behavioral|Regular aerobic physical exercise|"Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
~The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises."
16286727|NCT00741312|Behavioral|Activities of daily living|Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
16286728|NCT00741286|Drug|Aspirin|Asprin (100mg) plus placebo
16286729|NCT00741286|Drug|cilostazol|Aspirin (100mg) plus cilostazol (200mg)
16286730|NCT00741273|Drug|Proellex|Proellex 25 mg capsule, single dose
16286731|NCT00741260|Drug|Neratinib|Neratinib orally once daily continually
16286732|NCT00741260|Drug|Capecitabine|Capecitabine orally on days 1-14 of each 21 day cycle
16286733|NCT00741247|Procedure|EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)|EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA).
16286734|NCT00741234|Drug|SB939|SB939 taken orally in a 4-week cycle.
16286735|NCT00741234|Drug|Azacitidine|Azacitidine taken orally with SB939 in a 4-week cycle
16286736|NCT00741221|Drug|Pemetrexed|Pemetrexed (IV) 500 mg/m2 on day 1 every 3 weeks for 6 cycles
16286737|NCT00741221|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles After the end of the 6 cycles Bevacizumab will be administered alone at the dose of 15 mgr/Kgr (IV) every 3 weeks until disease progression
16286738|NCT00741208|Dietary Supplement|Soy Isoflavone|50mg soy isoflavone supplement consumed twice daily for a total of 100mg of soy isoflavones per day.
16286739|NCT00741195|Drug|Docetaxel|Docetaxel at the dose of 75 mg/m2 IV on days 1 every 3 weeks for 6 consecutive cycles.
16286740|NCT00741195|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
16286741|NCT00741182|Drug|rhPTH(1-34)|Injection of 20 micrograms per day in eight weeks
16286742|NCT00741169|Drug|TMC435350|200 mg taken by mouth once daily for 7 days
16286743|NCT00741169|Drug|Rifampin|600 mg taken by mouth once daily for 7 days
16286744|NCT00741169|Drug|TMC435350+rifampin|The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
16286745|NCT00741156|Drug|Enalaprilat|Enalaprilat will be administered intravenously i.v. 0.005 - 0.01 mg/kg i.v. over 1 minute
16286746|NCT00741143|Other|Fortification of wheat flour with NaFeEdta|NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months
16286747|NCT00741117|Procedure|Arterial Blood Gas|One blood gas sample will be obtained from an artery in the arm.
16286748|NCT00741117|Procedure|Pulse Oximetry Machine|A pulse oximetry machine will be used at one time point to obtain an oxygen saturation reading. This is done by placing a clip onto the finger. The pulse oximetry value displays on the pulse oximeter machine within seconds.
16286749|NCT00741117|Procedure|Direct and Indirect Serum Bilirubin Measurement|One tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels.
16286750|NCT00741104|Drug|Infliximab|Treatment of RA with Infliximab according to and under normal routine clinical practice.
16286751|NCT00741091|Device|Carotid WALLSTENT Monorail Endoprosthesis|A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
16286752|NCT00741091|Device|FilterWire EZ™ System™|Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
16286753|NCT00741078|Drug|statin, amlodipine|
16286754|NCT00741065|Procedure|Direct Epicardial Shock Wave Therapy|performed in adjunct to a standard coronary artery bypass grafting procedure Prior to aortic cross clamping direct epicardial shock wave therapy - applied directly to the myocardium
16286755|NCT00741052|Drug|Ciprofloxacin|12 hourly oral dose of ciprofloxacin for 3 days
16286756|NCT00741052|Drug|Azithromycin|1 gm Azithromycin single dose
16286757|NCT00741039|Biological|inactivated influenza vaccine and the 23- valent pneumococcal vaccine|Patients >65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23-valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured, as will serum IgG levels and IgG subtypes. At 8-16 weeks after vaccination, post vaccine titers, CBC, lymphoid phenotype and function will be assessed.
16286758|NCT00741039|Biological|inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)|MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly)and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured. At approximately 8-16 weeks after vaccination, post vaccine titers will be measured again.
16286759|NCT00741026|Drug|Olanzapine 10 mg po qhs for 3 days|(1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets)
16286760|NCT00741026|Drug|Placebo|(1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
16286761|NCT00741013|Drug|placebo pill and placebo IV|"Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
~Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS"
16286762|NCT00741013|Drug|Lovastatin pill and placebo IV|"lovastatin pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
~Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS"
16286763|NCT00741013|Drug|placebo pill and recombinant human activated protein C IV|"placebo pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
~recombinant human activated protein C IV 24 micrograms per kg per hour starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS"
16286764|NCT00741013|Biological|Endotoxin|Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.
16286765|NCT00741000|Procedure|Cervical Stairstep|Cervical low force mobilization procedure.
16286766|NCT00740987|Device|Intermittent pneumatic compression of the lower limbs|No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
16286767|NCT00740961|Behavioral|compliance monitoring|Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
16286768|NCT00740961|Drug|systemic chemotherapy|Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer
16286769|NCT00740961|Other|medical chart review|A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.
16286770|NCT00740961|Other|study of socioeconomic and demographic variables|Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
16286771|NCT00740961|Other|survey administration|Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
16286772|NCT00740961|Procedure|cognitive assessment|Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
16286773|NCT00740961|Procedure|psychosocial assessment and care|Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.
16286774|NCT00740948|Drug|Rituximab (mabthera) Injection|2 * 1g of Rituximab at the 1st day and at the 14th day.
16286775|NCT00740948|Drug|Placebo: NaCl 0.9% or Glucose 5%|2* 250ml of NaCl 0.9% or Glucose 5% at the 1st day and at the 14th day.
16286776|NCT00740935|Biological|Rotateq vaccine|"Vaccination against rotavirus
~Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose."
16286777|NCT00740922|Drug|Sterile becaplermin gel vs. sterile placebo gel treatment 1|Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).
16286778|NCT00740909|Behavioral|Cognitive Behavioral Therapy|A therapy designed to help patients with response prevention skills.
16286779|NCT00740896|Behavioral|Smoking|Active Comparator: Participants smoke 8 cigarettes in 4 hours.
16286780|NCT00740896|Behavioral|Smoking|Sham Comparator: Participants are not allowed to smoke for 4 hours.
16286781|NCT00740883|Drug|warfarin|18 months of warfarin therapy, once daily
16286782|NCT00740883|Drug|placebo of warfarin|18 months of placebo of warfarin therapy, once daily
16286783|NCT00740870|Device|Transcatheter Pulmonary Valve replacement|Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.
16286784|NCT00740857|Drug|placebo|2 placebo gels capsules delivered as a single dose.
16286785|NCT00740857|Drug|ibuprofen Formulation 1|2 marketed ibuprofen gels
16286786|NCT00740857|Drug|ibuprofen Formulation 2|2 marketed ibuprofen gels
16286787|NCT00740844|Device|Intermittent pneumatic compression of the lower limbs|Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
16286788|NCT00740831|Drug|PGL4001|tablets
16286789|NCT00740831|Drug|leuprorelin|solution for injection
16286790|NCT00740818|Other|No Intervention|The patient will lay prone on the adjustment table 5 minutes, the approximate equivalency of a Logan Basic adjustment. Table will be in proper position according to Logan Basic protocol.
16286791|NCT00740818|Procedure|Sham Logan Basic Adjustment|A thumb contact will be used against the sacrotuberous ligament as opposed to underneath the ligament. Auxiliary contacts will also be sham adjustments; the spine will be contacted but no force applied.
16286792|NCT00740818|Procedure|Logan Basic adjustment|Logan Basic adjustment, as well as auxiliary and abdominal contacts, based on the Logan Basic protocol.
16286793|NCT00740805|Drug|Cyclophosphamide|Given IV
16286794|NCT00740805|Drug|Doxorubicin Hydrochloride|Given IV
16286795|NCT00740805|Other|Laboratory Biomarker Analysis|Correlative studies
16286796|NCT00740805|Other|Pharmacological Study|Correlative studies
16286797|NCT00740805|Drug|Veliparib|Given PO
16286798|NCT00740792|Drug|azelastine HCl/fluticasone propionate|azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID
16286799|NCT00740792|Drug|azelastine Hcl|azelastine Hcl 548 mcg one spray per nostril BID
16286800|NCT00740792|Drug|fluticasone propionate|fluticasone propionate 200 mcg one spray per nostril BID
16286801|NCT00740792|Drug|placebo|placebo one spray per nostril BID
16286802|NCT00740779|Drug|Silodosin 8 mg|Silodosin 8 mg daily
16286803|NCT00740779|Drug|Placebo|Placebo
16286804|NCT00740779|Drug|Silodosin 4 mg|Silodosin 4 mg daily
16286856|NCT00740415|Drug|Bendamustine|-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
16286857|NCT00740389|Drug|TMC125|
16286943|NCT00739791|Other|questionnaire administration|
16286805|NCT00740766|Behavioral|Food diary and behavioral model|"The monitored group is to be placed on a prenatal nutritional program consisting of 18 to 24 kcal. per kg. (according to the patient's actual weight) with monitoring each visit.
~The patients will be weighed each prenatal visit with the monitored patients weighed and blinded to their actual weight (being weighed with her back to the scale). The monitored patients will be requested not to weigh at home and all patients will be asked to wear similar clothing at each visit.
~All intervention (monitored) group women will be asked to record in a diary all of the foods eaten during each day. These records will be reviewed at each prenatal visit. Six weeks after delivery, the patient will be weighed and will then exit the study. The food diary notebooks will be collected from each patient at the end of the study."
16286806|NCT00740753|Device|Yttrium 90 (TheraSphere)|Y-90 embedded glass microspheres
16286807|NCT00740727|Drug|Human recombinant hyaluronidase (HRH)|150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
16286808|NCT00740727|Procedure|Enzymatically Augmented Subcutaneous Infusion (EASI) line placement|Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.
16286809|NCT00740714|Drug|Coenzyme Q10 with vitamin E|2400 mg dose - eight 300 mg Coenzyme Q10 chewable wafers taken orally four times a day; 1200 mg dose - four 300 mg Coenzyme Q10 and four placebo chewable wafers taken orally four times a day.
16286810|NCT00740714|Drug|placebo with vitamin E|placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.
16286811|NCT00740701|Device|Cerebellar transcranial magnetic stimulation|single pulse TMS or repetitive TMS at 1 Hz frequency
16286812|NCT00740688|Procedure|Logan Basic Apex Contact|A Logan Basic Apex Contact, which is a contact that is placed on the anterior surface of the sacrotuberous ligament with a light force directed posterior with varying degrees of laterality.
16286813|NCT00740688|Procedure|Sham Logan Basic apex contact|light force contact applied to the inferior surface of the sacrotuberous ligament, directed straight superiorly.
16286814|NCT00740675|Other|Outpatient Medication Reconciliation|"The post-discharge medication reconciliation module has the following features:
~Presents the (preadmission) ambulatory medication list and the hospital discharge medication list side-by-side, sorted by class, with all identical medications lined up next to each other and all differences in the two regimens highlighted.
~Allows users to update the ambulatory medication list with a few keystrokes (i.e., to accept individual changes made during the hospitalization).
~Allows reconciliation to be performed in full (e.g., for PCPs who are responsible for the entire medication list) or in part (e.g., for specialists)."
16286815|NCT00740662|Procedure|Distal gastric bypass|Distal gastric bypass
16286816|NCT00740649|Drug|HSD-016|
16286817|NCT00740649|Drug|placebo|
16286818|NCT00740636|Drug|Temozolomide|Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day.
16286819|NCT00740636|Drug|Temozolomide|Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.
16286820|NCT00740623|Drug|Carisbamate|800 mg/day for 14 weeks
16286821|NCT00740623|Drug|placebo|placebo for 14 weeks
16286822|NCT00740623|Drug|Carisbamate|1,200 mg/day for 14 weeks
16286823|NCT00740610|Drug|GS-9450|GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
16286824|NCT00740610|Drug|GS-9450 Placebo|Placebo to match GS-9450 administered orally once daily
16286825|NCT00740597|Genetic|gene expression analysis|
16286826|NCT00740597|Genetic|polymerase chain reaction|
16286827|NCT00740597|Genetic|western blotting|
16286828|NCT00740597|Procedure|neoadjuvant therapy|
16286829|NCT00740597|Procedure|therapeutic conventional surgery|
16286830|NCT00740597|Radiation|intensity-modulated radiation therapy|
16286831|NCT00740584|Drug|3% SPL7013 Gel (VivaGel)|A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.
16286832|NCT00740571|Drug|amitriptyline|strategy in which the patient starts with amitriptyline, during 8 weeks
16286833|NCT00740571|Drug|pregabalin|Strategy in which patient starts with pregabalin
16286834|NCT00740558|Procedure|Activator methods technique|Chiropractic adjustment by a manually assisted mechanical force
16286835|NCT00740558|Procedure|Traditional chiropractic adjustment|Lumbar roll according to the Diversified technique of chiropractic adjusting
16286836|NCT00740545|Drug|enoxaparine 40 mg daily|Women inject ourselves every days with 40 mg of enoxaparine
16286837|NCT00740545|Drug|placebo|Women inject ourselves every days with placebo
16286838|NCT00740532|Genetic|Gene mutation analyses and FISH|FISH and mutation analyses of multiple genes
16286839|NCT00740519|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
16286840|NCT00740506|Behavioral|Frequency of Intercourse|
16286841|NCT00740493|Drug|warfarin|18 months of warfarin therapy
16286842|NCT00740493|Drug|placebo of warfarin|18 months of placebo of warfarin therapy
16286843|NCT00740467|Biological|anti-thymocyte globulin|
16286844|NCT00740467|Drug|busulfan|
16286845|NCT00740467|Drug|cyclophosphamide|
16286846|NCT00740467|Drug|cyclosporine|
16286847|NCT00740467|Drug|fludarabine phosphate|
16286848|NCT00740467|Drug|mycophenolate mofetil|
16286849|NCT00740467|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16286850|NCT00740454|Other|Lower limb veins compression ultrasonography|Distal and proximal lower limb veins compression ultrasonography
16286851|NCT00740441|Drug|AS1411|AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles
16286852|NCT00740428|Procedure|Pregnants for receive the physical therapy guide|pregnants for the first time who will receive the physical therapy guide, perform the exercises under the supervision of a physical therapist, and complete an exercise compliance form and a log with information on urinary losses.
16286853|NCT00740415|Biological|rituximab|Rituximab, 375 mg/m2 Intraveinous
16286854|NCT00740415|Drug|bortezomib|-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
16286855|NCT00740415|Drug|dexamethasone|day - Dexamethasone, 40 mg Intraveinous
16286858|NCT00740376|Device|Uniglide Mobile Bearing Unicondylar Knee System|Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
16286859|NCT00740376|Device|Uniglide Fixed Bearing Unicondylar Knee System|Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
16286860|NCT00740363|Drug|sitagliptin|Once daily sitagliptin. If GFR>50 ml/min/1.73m2: 100 mg/day. If GFR from 25 to 49 ml/min/1.3m2: 50 mg/day
16286861|NCT00740363|Drug|placebo|No active sitagliptin treatment for 4 weeks
16286862|NCT00740350|Procedure|Logan Basic|Logan Basic chiropractic adjustments during pregnancy.
16286863|NCT00740324|Drug|NPO-11|20 mg butylscopolammonium bromide after administration of NPO-11
16286864|NCT00740324|Drug|NPO-11|NPO-11 after administration of NPO-11
16286865|NCT00740324|Drug|NPO-11|1 mg glucagons after administration of NPO-11
16286866|NCT00740311|Device|MBCP gel TM|alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
16286867|NCT00740298|Other|sucrose|sweet taste
16286868|NCT00740298|Other|warmth|warmth
16286869|NCT00740285|Drug|Lidocaine 2% without vessel constrictor|"first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours
~next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days"
16286870|NCT00740285|Other|Placebo - physiological solution 0,9%|first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
16286871|NCT00740272|Procedure|AF ablation + pacemaker implantation|regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)
16286872|NCT00740272|Procedure|Pacemaker implantation|regular pacemaker implantation
16286873|NCT00740259|Drug|Flunarizine|For 1 week, 40 mg/day. From week 2 to 3, 20 mg/day. Form week 4 onwards, dosage increment or reduction of 10mg/day was allowed according to efficacy and tolerability.
16286874|NCT00740246|Drug|VIT-45|
16286875|NCT00740207|Drug|VISIPAQUE 270|VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
16286876|NCT00740207|Drug|Isovue 250|ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
16286877|NCT00740194|Drug|Aromatase inhibition|Letrozole
16286878|NCT00740194|Drug|Estradiol|Dermestril
16286879|NCT00740181|Drug|chemotherapy|
16286880|NCT00740168|Drug|bevacizumab treatment|single infusion 10 mg/kg
16286881|NCT00740155|Biological|Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)|0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
16286882|NCT00740155|Biological|Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)|0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
16286883|NCT00740155|Biological|Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)|0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
16286884|NCT00740155|Biological|Tetravalent CYD-1,2,3,4 Dengue (Vero)|0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
16286885|NCT00740155|Biological|JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)|0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
16286886|NCT00740142|Drug|L-ornithine-L-aspartate and lactulose|L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
16286887|NCT00740142|Drug|placebo and lactulose|placebo 3 times a day for 7 days
16286888|NCT00740129|Drug|Zoledronic Acid|Zoledronic acid 5 mg intravenous infusion once
16286889|NCT00740116|Drug|Tranexamic acid|Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery
16286890|NCT00740116|Drug|0.9% NaCl solution|0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery.
16286891|NCT00740103|Drug|Semapimod|60 mg IV x 3 days q 6 - 8 weeks
16286892|NCT00740090|Drug|AMA1-C1/Alhydrogel plus CPG 7909|
16286893|NCT00740077|Other|Low calorie, sugar-free cranberry juice cocktail (54% juice)|Single-dose, 24 hour pharmacokinetic trial of 8 oz dose administered orally.
16286894|NCT00740064|Drug|Raltegravir and Abacavir/Lamivudine|Raltegravir 400mg BID Abacavir/Lamivudine 1 tablet QD
16286895|NCT00740051|Drug|Linagliptin|5mg once daily
16286896|NCT00740051|Drug|Linagliptin Placebo|0 mg placebo comparator for part 1 of study (to 18 weeks)
16286897|NCT00740051|Drug|Glimepiride|1-4mg for part 2 of study (weeks 19-52)
16286898|NCT00740038|Behavioral|Stress Management training|Self-administered stress management training comprising 10 minute introduction by staff, & provision of DVD, CD,brochure, and workbook. Materials provide overview of sources of stress during chemotherapy, and instruction in cognitive-behavioral stress management techniques (paced abdominal breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements). Daily use is encouraged over 13-14 weeks of the study.
16286899|NCT00740038|Behavioral|Exercise Training|Home-based exercise (walking) program: brief introduction by staff (10 minutes) and provision of packet with DVD, brochure, workbook, pedometer (electronic step counter) along with instructions on initiating and maintaining a walking program. Dose Recommendations: 3-5 exercise session per week for at least 20-30 minutes at maximum intensity of 50 to 75% of their estimated heart rate reserve (RPE of 11-13) which is calculated based on their age and resting pulse.
16286900|NCT00740038|Behavioral|Usual care|Usual psychosocial care and provision of NCI booklet, Chemotherapy and You (NCI, 1999) which gives general feedback about fitness testing, exercise and stress management during chemotherapy. Recommended to read booklet at least once.
16286938|NCT00739791|Genetic|polymerase chain reaction|
16286901|NCT00740038|Behavioral|Combined stress management and exercise training|Home-based, self-administered stress management and exercise (walking) program: brief introduction by staff and provision of DVD, CD, brochure, pedometer, workbook. Dose Recommendations: walking/exercise program (3-5 times per week for at least 20-30 minutes) and use of CD (progressive muscle relaxation with guided imagery) and coping statements once per day.
16286902|NCT00740012|Other|Continuous glucose monitoring|Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
16286903|NCT00740012|Other|alarm- clock intervention, patient perform blood glucose self monitoring|Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
16286904|NCT00740012|Other|nurse intervention|Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
16286905|NCT00740012|Other|Taking the patients pulse|In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
16286906|NCT00740012|Other|Venous blood drawing|Venous blood drawing for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany) (6-10 minutes after midnight, 2 a.m., 4 a.m. and 6:45 a.m.)in night (a) and (b)
16286907|NCT00740012|Other|Other capillary sample|5-7 minutes after the alarm clock or the nurse the doctoral candidate takes another capillary sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany) analyzer.
16286908|NCT00739999|Drug|Atorvastatin|6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
16286909|NCT00739999|Drug|Atorvastatin|10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
16286910|NCT00739986|Drug|Semapimod|semapimod 60 mg IV x 1 day, placebo x 2 days
16286911|NCT00739986|Drug|Semapimod|Semapimod 60 mg IV x 3 days
16286912|NCT00739986|Drug|Placebo|placebo IV x 3 days
16286913|NCT00739973|Drug|Placebo|
16286914|NCT00739973|Drug|Aliskiren 150 mg tablet|
16286915|NCT00739973|Drug|Aliskiren 300 mg tablet|
16286916|NCT00739973|Drug|Amlodipine 5 mg capsule|
16286917|NCT00739973|Drug|Amlodipine 10 mg capsule|
16286918|NCT00739973|Drug|Aliskiren/amlodipine 150/5 mg tablet|
16286919|NCT00739973|Drug|Aliskiren/amlodipine 150/10 mg tablet|
16286920|NCT00739973|Drug|Aliskiren/amlodipine 300/5 mg tablet|
16286921|NCT00739973|Drug|Aliskiren/amlodipine 300/10 mg tablet|
16286922|NCT00739960|Drug|Abatacept|10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
16286923|NCT00739947|Other|Observational study of the surgical outcome|Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.
16286924|NCT00739934|Drug|voriconazole (Vfend)|"Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h
~Notes:
~If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
~Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
~(IV = Intravenous; POS = Powder for oral suspension)"
16286925|NCT00739921|Procedure|Nasal swab under endoscopic guidance|"After the application of pontocaine and neosynephrine spray, the following will be done:
~A small sponge applicator will be used to swab the inside of your mouth for saliva collection
~A blood sample (6cc - one tube) will be collected
~A small brush applicator called a cytology brush and an instrument called an endoscope will be used to swab the inside of your nose (middle meatus)
~Subjects will be asked to complete 2 standard quality of life questionnaires regarding how much your symptoms bother you
~You will be asked to bring in a vacuum cleaner bag from home at a follow-up appointment which will be swabbed as well
~The samples will be refrigerated and analyzed using PCR to detect and speciate fungus."
16286926|NCT00739908|Drug|CX157 (TriRima)|Six capsules administered three times a day for six weeks.
16286927|NCT00739908|Drug|Placebo|Six capsules administered three times a day for six weeks.
16286928|NCT00739895|Procedure|Cardiac magnetic Resonance study|follow-up studies
16286929|NCT00739895|Procedure|Blood testing|Blood sample tested for myocardial biomarkers
16286930|NCT00739882|Drug|Efalizumab - anti CD11a recombinant human monoclonal antibody|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
16286931|NCT00739882|Drug|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
16286932|NCT00739856|Procedure|Electroconvulsive Therapy|ECT was administered using the MECTA-SR1 apparatus. The current amplitude was 800 mA, pulse width was 1.5 ms, and pulse frequency was 50 Hz. Stimulus duration was increased as required to elicit an adequate seizure, defined as at least 25 s with EEG monitoring. The ECT course was fixed, and comprised 6 treatments administered with bitemporal electrode placement at a twice-weekly frequency
16286933|NCT00739830|Drug|ridaforolimus|40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
16286934|NCT00739830|Drug|medroxyprogesterone acetate tablets OR megestrol acetate|oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
16286935|NCT00739830|Drug|chemotherapy|Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
16286936|NCT00739791|Behavioral|exercise intervention|
16286937|NCT00739791|Genetic|gene expression analysis|
16286944|NCT00739791|Procedure|psychosocial assessment and care|
16286945|NCT00739791|Procedure|quality-of-life assessment|
16286946|NCT00739791|Procedure|support group therapy|
16286947|NCT00739791|Procedure|therapeutic dietary intervention|
16286948|NCT00739778|Other|food - novel sweetener|concentration to be isosweet with 4.7% sucrose
16286949|NCT00739778|Other|food vehicle blank|water blank
16286950|NCT00739778|Other|food - sweetener, positive control|4.7% sucrose in water
16286951|NCT00739778|Other|food - sweetener, negative control|non-cariogenic sweetener at concentration isosweet with 4.7% sucrose
16286952|NCT00739765|Behavioral|Interpersonal Psychotherapy|14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
16286953|NCT00739765|Behavioral|Prolonged Exposure Therapy|Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
16286954|NCT00739765|Behavioral|Relaxation Therapy|Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
16286955|NCT00739752|Behavioral|Non-Framed-Offered|Subjects received information only and are offered the vaccine.
16286956|NCT00739752|Behavioral|Non-Framed-Recommended|Subjects receive information only and are recommended the vaccine.
16286957|NCT00739752|Behavioral|Gain-Framed-Offered|Subjects receive gain-framed messages and are offered the vaccine.
16286958|NCT00739752|Behavioral|Gain-Framed-Recommended|Subjects receive gain-framed messages and are recommended the vaccine.
16286959|NCT00739752|Behavioral|Loss-Framed-Offered|Subjects receive loss-framed messages and are offered the vaccine.
16286960|NCT00739752|Behavioral|Loss-Framed-Recommended|Subjects receive loss-framed messages and are recommended the vaccine.
16286961|NCT00739739|Drug|PD 0299685 at 15mg BID|5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
16286962|NCT00739739|Drug|PD 0299685 at 30mg BID|10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
16286963|NCT00739739|Drug|placebo for PD 0299685|Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
16286964|NCT00739713|Dietary Supplement|Sea buckthorn (Hippophaë rhamnoides) oil|Dosage 2 g/d, frequency twice/d, duration 3 months
16286965|NCT00739713|Dietary Supplement|Placebo comparison|Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months
16286966|NCT00739687|Drug|ALT-711|200 mg tablet BID for 9 months.
16286967|NCT00739687|Drug|Placebo|200 mg tablet BID for 9 months.
16286968|NCT00739674|Drug|losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])|"Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows:
~Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes:
~Losartan 50 mg
~Losartan 100 mg
~Losartan 100 mg/HCTZ 12.5 mg
~Losartan 100 mg/HCTZ 25 mg
~Losartan 100 mg/HCTZ 25 mg + CCB
~Patients with severe hypertension:
~Losartan 50 mg/HCTZ 12.5 mg
~Losartan 100 mg/HCTZ 12.5 mg
~Losartan 100 mg/HCTZ 25 mg
~Losartan 100 mg/HCTZ 25 mg + CCB
~Losartan 100 mg/HCTZ 25 mg + increasing CCB"
16286969|NCT00739674|Behavioral|Low Salt Diet|"Low-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including:
~Healthy diet
~Reduction in sodium intake to less than 2300 mmol/day
~Low alcohol consumption (less than 2 standard drinks/day)"
16286970|NCT00739661|Drug|Vismodegib 150 mg|Vismodegib 150 mg was provided in hard gelatin capsules.
16286971|NCT00739661|Drug|Placebo to vismodegib|Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.
16286972|NCT00739648|Drug|MP-376|MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
16286973|NCT00739648|Drug|Placebo|same frequency as study drug using the same method of delivery
16286974|NCT00739635|Drug|Neramexane mesylate|Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
16286975|NCT00739635|Drug|Placebo|Double-blind treatment period of 17 weeks placebo
16286976|NCT00739622|Drug|TMC278|
16286977|NCT00739609|Drug|1-methyl-D-tryptophan|D-1MT will be administered in escalating doses. Initial dosing will be 200 mg by mouth daily with escalation planned to 2000 mg by mouth daily and potentially higher doses in subsequent cohorts if tolerated and pharmacokinetic and biologic data support further dose escalation.
16286978|NCT00739596|Drug|Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
16286979|NCT00739596|Drug|Amlodipine: 8 weeks|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
16286980|NCT00739583|Drug|CHG 2% w/v and IPA 70% v/v|Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds
16286981|NCT00739583|Drug|Iodophor 0.7% and IPA 74% w/w|Skin preparation of the surgical site per product labeling. The area will be painted with the solution.
16286982|NCT00739570|Device|AAI signature IV AMCT|Chiropractic adjustments of the lumbar spine following the activator basic scan protocol
16286983|NCT00739544|Other|1|Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device
16286984|NCT00739531|Device|Exhaled nitric oxide (eNO)|Subjects will perform a controlled breath maneuver using both the Apieron and NIOX devices. The devices will measure nitric oxide in the subjects' exhaled breath.
16286985|NCT00739518|Procedure|MRI|Neurological MRI with new technology evaluation. The new technology may involve software or MRI scanning sequences. This is a long term research study that focuses on new technology that is constantly being created.
16287027|NCT00739050|Drug|simvastatin|simvastatin 20mg daily at nights for 12 weeks. Tablets
16287028|NCT00739050|Drug|Comparator: Placebo|placebo daily at nights for 12 weeks. Tablets
16287029|NCT00739037|Drug|Placebo|
16287030|NCT00739037|Drug|PAZ-417|
16287031|NCT00739024|Drug|Ramelteon|8 mg tablet, oral, once daily
16287032|NCT00739024|Drug|Placebo|Placebo tablet, oral, once daily
16286986|NCT00739505|Biological|Asfotase Alfa|"The initial IV dose to be administered to patients was set at one-tenth the no adverse effect level (NOAEL) as determined by one month toxicology studies in animals in which Asfotase Alfa was administered as a single weekly IV dose. The SC doses to be administered are lower than the IV doses and are thought to be near or at the anticipated daily efficacious dose. Dosing will be as follows:
~Cohort 1: In Week 1, patients will receive an IV infusion of Asfotase Alfa at a dose of 3 mg/kg. In Weeks 2, 3 and 4, patients will receive weekly SC injections of Asfotase Alfa at a dose of 1 mg/kg SC."
16286987|NCT00739505|Biological|Asfotase Alfa|Cohort 2: In Week 1, patients will receive an IV infusion of Asfotase Alfa at a dose of 7 mg/kg. In Weeks 2, 3 and 4, patients will receive weekly SC injections of Asfotase Alfa at a dose of 1.5 mg/kg SC.
16286988|NCT00739492|Behavioral|financial incentives|financial incentives based on attaining weight loss goals
16286989|NCT00739479|Dietary Supplement|Weight Loss|Participants will reduce their total dietary intake by ~800 kcal/day. ~100 kcal will be replaced by either the PHWP of PHG protein supplement, resulting in a total energy restriction of ~700 kcal/day.
16286990|NCT00739466|Drug|Liposomal Alendronate|IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
16286991|NCT00739466|Drug|Liposomal Alendronate|IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
16286992|NCT00739466|Drug|Saline infusion (placebo)|IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
16286993|NCT00739453|Drug|OSI-906|administered orally
16286994|NCT00739453|Drug|erlotinib|administered orally
16286995|NCT00739440|Biological|serum antiscorpion|The dose may be required for the patient according to clinical manifestations and evolution
16286996|NCT00739414|Drug|LBH589|10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
16286997|NCT00739401|Device|Suprarenal Proximal Cuff Extension|Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
16286998|NCT00739388|Drug|azacytidine|100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
16286999|NCT00739375|Procedure|Primary arterio-venous vascular access creation|Primary arterio-venous vascular access creation, ECHO with pulmonary artery pressure measurements, Assessment of blood NO metabolite levels
16287002|NCT00739349|Drug|NOVA22007 ''Cyclosporine''|Cyclosporine 0.05% Ophthalmic Cationic Emulsions
16287003|NCT00739349|Drug|NOVA22007 ''Cyclosporine''|Cyclosporine 0.1% Ophthalmic Cationic Emulsions
16287004|NCT00739349|Drug|vehicle/placebo|vehicle/placebo
16287005|NCT00739336|Behavioral|Diabetes Prevention and Control|The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.
16287006|NCT00739310|Device|Vest Treatment (high frequency chest wall oscillation)|twice daily for 15-20 minutes
16287007|NCT00739297|Drug|Comparator: montelukast|5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
16287008|NCT00739297|Drug|Comparator: placebo|5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
16287009|NCT00739284|Device|nephrostomy tube and ureteral stent|
16287010|NCT00739271|Other|Early feeding|
16287011|NCT00739271|Other|late feeding after bowel sounds return|Traditional method
16287012|NCT00739232|Drug|HSD-016|
16287013|NCT00739232|Other|placebo|
16287014|NCT00739219|Device|Apieron Insight eNO monitor|The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
16287015|NCT00739206|Drug|SAR97276A|Dose based on body weight
16287016|NCT00739193|Drug|amiodarone|
16287017|NCT00739180|Other|Control|Standard care control (no exercise)
16287018|NCT00739180|Other|Resistance Exercise|Supervised resistance exercise using stack weight equipments.
16287019|NCT00739180|Other|Aerobic exercise|Supervised aerobic exercise using treadmills, bikes, and ellipticals
16287021|NCT00739128|Biological|hepatitis B vaccine (EngerixB)|A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscular at zero, one and six months intervals
16287022|NCT00739128|Biological|hepatitis B vaccine (EngerixB)|A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intradermally in the deltoid region at zero, one and six months intervals
16287023|NCT00739115|Other|Heliox gas|Heliox gas used in conjunction with nasal CPAP
16287024|NCT00739102|Device|S.M.A.R.T. ® Stent|The Cordis S.M.A.R.T.® Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
16287025|NCT00739076|Behavioral|Virtual Reality|Using Virtual Reality for pain control
16287026|NCT00739063|Drug|Tarceva|Tarceva (erlotinib hydrochloride) given alone, at 150 mg by mouth daily.
16287033|NCT00739011|Device|SleepStyle 254/244 CPAP series CPAP humidifier|Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20
16287034|NCT00738998|Behavioral|Questionnaire|Questionnaires about pain and other symptoms, quality of life, and ability to work will be completed.
16287035|NCT00738998|Other|Phone Calls|A telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes.
16287036|NCT00738985|Drug|ezetimibe/simvastatin 10/20 mg + placebo|Patients will receive placebo (sugar tablets) for up to 22 weeks.
16287037|NCT00738985|Drug|ezetimibe/simvastatin 10/20 mg + MK0524A|ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets
16287038|NCT00738972|Drug|valsartan|80 mg valsartan. Duration: 12 months. Tablets
16287039|NCT00738972|Drug|pravastatin|40 mg pravastatin. Duration: 12 months. Tablets
16287040|NCT00738972|Drug|simvastatin|40 mg simvastatin. Duration: 12 months. Tablets
16287041|NCT00738972|Drug|ezetimibe (+) simvastatin|ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
16287042|NCT00738959|Drug|AZD0328|Oral solution A single dose Day 1 followed by once daily doses on Day 3-7
16287043|NCT00738946|Drug|Intermittent preventive treatment with AQ+ SP|Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval
16287044|NCT00738933|Dietary Supplement|Dietary plant stanols|Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation
16287045|NCT00738933|Dietary Supplement|Dietary plant sterols|Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation
16287046|NCT00738933|Dietary Supplement|placebo|Margarine product without plant stanol or sterol esters
16287047|NCT00738920|Behavioral|Self Administered Cognitive Behavior Therapy|This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
16287048|NCT00738920|Behavioral|Therapist Administered Cognitive Behavior Therapy|This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
16287049|NCT00738920|Behavioral|Behavioral Education and Supportive Therapy|This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
16287050|NCT00738894|Device|Septal Occluder Device|PFO closure with study septal occluder device
16287051|NCT00738894|Drug|Antiplatelet Medical Therapy|Investigator's choice of one of three regimen options specified in protocol
16287052|NCT00738881|Drug|Erlotinib Hydrochloride|Given PO
16287053|NCT00738881|Drug|Pemetrexed Disodium|Given IV
16287054|NCT00738868|Biological|cetuximab|
16287055|NCT00738868|Radiation|stereotactic body radiation therapy|
16287056|NCT00738855|Other|Oral Gastrografin|100 ml of the dye administered through a nasogastric tube
16287057|NCT00738855|Other|Nothing per os|A nasogastric tube
16287058|NCT00738842|Drug|AZD6140|Oral tablets taken bid for 5 days
16287059|NCT00738842|Drug|Placebo to match AZD6140|Oral tablets taken bid for 5 days
16287060|NCT00738829|Drug|Lenalidomide|"Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity.
~During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage."
16287061|NCT00738829|Drug|Fludarabine|25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
16287062|NCT00738829|Biological|Rituximab|"Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6.
~Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage."
16287063|NCT00738816|Other|Systematic medication review and advisory notes|Within 24 hours of admission a pharmacist retrieve medication histories from patients included in the intervention group. Medication histories will be obtained from - medical records, medication charts, patients electronical medication profile, interview with patients and if necessary contact to the patients general practitioner. The obtained medication history will be discussed with a physician specialized in pharmacology and an advisory note with suggested changes to the patients medication is added to the medical record. The orthopedic physicians are not obliged to follow the suggested changes
16287064|NCT00738803|Procedure|Total hip replacement|Total hip replacement typically preformed for hip arthritis
16287065|NCT00738790|Radiation|Short course of radiotherapy|5 x 5 Gy plus boost 4 Gy
16287066|NCT00738790|Radiation|Radiochemotherapy|28 x 1,8Gy plus boost 3 x 1,8 Gy with three 2-days cycles of chemotherapy during weeks 1, 3 and 5 of irradiation (the each cycle consisted of leukovorin 20 mg/m2 per day and 10-20 minutes later of 5-fluorouracil 400 mg/m2 per day, both administrated as rapid intravenous infusion)
16287067|NCT00738777|Drug|Anastrozole|1 mg,QD,PO
16287068|NCT00738777|Drug|Anastrozole+Fulvestrant|Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
16287069|NCT00738777|Drug|Tamoxifen|loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
16287070|NCT00738777|Drug|Tamoxifen|loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
16287071|NCT00738764|Biological|PDL192|Humanized anti-TWEAK receptor monoclonal IgG1 antibody
16287072|NCT00738751|Drug|Panobinostat (LBH589)|Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle. Each cycle was defined as a 21-day period. Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg. Doses were not escalated over the course of treatment of an individual participant.
16287113|NCT00738413|Drug|Deferasirox|Deferasirox will be orally administered at a dose of 30 mg/kg once daily for 6 days.
16287114|NCT00738400|Drug|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
16287115|NCT00738400|Drug|Placebo|Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
16287116|NCT00738387|Drug|ASA404|1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle
16287073|NCT00738751|Drug|erlotinib|Erlotinib was taken daily without interruption. Each cycle was defined as a 21-day period. Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle. Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg. Doses were not escalated over the course of treatment of an individual participant.
16287074|NCT00738738|Drug|PD-0332334|Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
16287075|NCT00738712|Procedure|MRI Magnetic Resonance Imaging|MRI
16287076|NCT00738699|Drug|MORAb-003 (farletuzumab)|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
16287077|NCT00738699|Drug|0.9% Saline|Placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
16287078|NCT00738699|Drug|Paclitaxel|
16287079|NCT00738686|Device|Intracoronary stent implantation|Taxus stent implantation in patients with multivessel coronary artery disease
16287080|NCT00738673|Drug|degarelix|Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).
16287081|NCT00738660|Drug|Telmisartan, Ramipril|80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks
16287082|NCT00738647|Procedure|Tooth restorations with composite|The cavity is excavated and filled according to the guidelines for composite restorations
16287083|NCT00738634|Behavioral|Self-motivated physical activity|"Components:
~Physical activity education in the form of a brief booklet (double sided A4 page).
~Physical activity motivation tips (one sided A4 page).
~Pedometer
~Monitoring chart
~Online presentation of common obstacles and ways to overcome these obstacles"
16287084|NCT00738634|Behavioral|Nutrition|"Components:
~Nutrition education booklet (Double-sided A4 page)
~Nutrition motivation tips (single-sided A4 page)
~Nutrition monitoring chart
~Online presentation of common obstacles and ways to overcome these obstacles"
16287085|NCT00738634|Behavioral|Physical activity researcher contact|"Behavioral: Self-motivated physical activity
~Components:
~Physical activity education in the form of a brief booklet (double sided A4 page).
~Physical activity motivation tips (one sided A4 page).
~Pedometer
~Monitoring chart
~Online presentation of common obstacles and ways to overcome these obstacles"
16287086|NCT00738621|Drug|Aprepitant, Dexamethasone, Ondansetron|Aprepitant oral 40mg one dose, dexamethasone IV 4mg one dose, ondansetron 4 mg one dose
16287087|NCT00738621|Drug|Aprepitant, Dexamethasone, Placebo|Aprepitant 40mg oral one time, dexamethasone IV 4mg one time placebo one time
16287088|NCT00738595|Drug|EVT 302|EVT 302 5 mg once daily
16287089|NCT00738595|Drug|Placebo|Placebo to match EVT 302, 5 mg
16287090|NCT00738595|Drug|EVT 302 plus open label Nicotine replacement|Double-blind EVT 302 plus open label nicotine replacement
16287091|NCT00738595|Drug|Placebo plus open label Nicotine Replacement|Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
16287092|NCT00738582|Drug|MORAb-009 (Amatuximab)|MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
16287093|NCT00738582|Drug|Pemetrexed|Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
16287094|NCT00738582|Drug|Cisplatin|Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
16287095|NCT00738569|Drug|Raltegravir|Raltegravir 400 mg PO BID for 12 months
16287096|NCT00738556|Device|Drug-eluting stents (Cypher and Taxus)|Spot or full length stenting of a coronary lesion
16287097|NCT00738543|Other|WHOLE GROUP OF 48 VOLUNTEERS|Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics. The intervention consisted of preparing the skin with the antiseptic or the control. The areas were approximately 25 cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was then kept on the skin for 60 seconds before the bacterial culture was conducted. All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period.
16287098|NCT00738530|Drug|Bevacizumab [Avastin]|10 mg/kg IV every 2 weeks
16287099|NCT00738530|Drug|Interferon alfa 2a [Roferon]|9 MIU SC 3 times/week
16287100|NCT00738530|Drug|Placebo|IV every 2 weeks
16287101|NCT00738517|Device|Immunoadsorption / Immunoglobulin substitution|Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)
16287102|NCT00738478|Device|nasogastric tube|insertion of nasogastric tube for 2 days after operation
16287103|NCT00738478|Device|without nasogastric tube|without nasogastric tube after operation
16287104|NCT00738452|Other|high performance liquid chromatography|Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion.
16287105|NCT00738452|Other|pharmacological study|Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion.
16287106|NCT00738452|Procedure|radionuclide imaging|Approximately 1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post infusion.
16287107|NCT00738452|Procedure|single photon emission computed tomography|Approximately 2 days and 3-5 days post infusion
16287108|NCT00738452|Radiation|radiation therapy|3-6 mCi Indium-111 labeled cT84.66(5mg) and dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66.
16287109|NCT00738452|Radiation|yttrium Y 90 anti-CEA monoclonal antibody cT84.66|Dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66.
16287110|NCT00738426|Device|Erchonia ML Scanner (MLS)|Red diode low level laser light energy.
16287111|NCT00738426|Device|Sham device|non-therapeutic light energy output
16287112|NCT00738413|Drug|Deferoxamine|Deferoxamine will be administered subcutaneously over 8 hours for 6 days at a dose of 40 mg/kg.
16287117|NCT00738387|Drug|Placebo|Placebo i.v. on day 1 of each 21 day cycle
16287118|NCT00738387|Drug|docetaxel|75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
16287119|NCT00738374|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
16287120|NCT00738374|Drug|chlorambucil|8mg/m2 po on days 1-7 of courses 1-8
16287121|NCT00738361|Drug|nab-paclitaxel|150 mg/m2 weekly for 3 of 4 weeks every 28 days.
16287122|NCT00738348|Drug|sivelstat|sivelstat sodiumhydrate
16287123|NCT00738348|Drug|glucose|glucose
16287124|NCT00738335|Drug|erlotinib hydrochloride|
16287125|NCT00738335|Other|immunoenzyme technique|
16287126|NCT00738335|Other|laboratory biomarker analysis|
16287127|NCT00738335|Other|liquid chromatography|
16287128|NCT00738335|Other|mass spectrometry|
16287129|NCT00738335|Other|pharmacological study|
16287130|NCT00738335|Radiation|stereotactic radiosurgery|
16287131|NCT00738322|Drug|AZD1305|Solution for iv infusion, single dose
16287132|NCT00738322|Drug|Placebo|NaCl solution for iv infusion, single dose
16287133|NCT00738296|Drug|ezetimibe (+) simvastatin|Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets
16287134|NCT00738296|Drug|simvastatin|Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets
16287135|NCT00738296|Drug|pravastatin|Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets
16287136|NCT00738257|Drug|Pamidronate|
16287137|NCT00738231|Behavioral|Training|The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
16287138|NCT00738231|Behavioral|Training|The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
16287139|NCT00738218|Other|Multidetector Computed Tomography - 64 detectors|Multidetector computed tomography angiography
16287140|NCT00738192|Drug|Fentanyl citrate|Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
16287141|NCT00738192|Drug|Sufentanil citrate|Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
16287142|NCT00738192|Drug|Butorphanol tartrate|Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished
16287143|NCT00738179|Device|Continuous Positive Airway Pressure (CPAP)|CPAP worn nightly
16287144|NCT00738179|Other|Standard care|Standard care of cardiovascular risk factors
16287145|NCT00738166|Other|Organic or conventional diet|12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
16287146|NCT00738166|Other|Diet (organic or conventional)|organic or conventional diet
16287147|NCT00738153|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16287148|NCT00738140|Behavioral|Diabetes Prevention Program|12-lesson program which will cover diet, exercise, and behavior modification.
16287149|NCT00738127|Procedure|Open reduction and internal fixation|Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint. This technique is effective, however, it has some problems. In the study, we improve the surgical technique.
16287150|NCT00738101|Drug|Omegaven|Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
16287151|NCT00738088|Drug|gliclazide|Gliclazide 80mg bd for 6 weeks
16287152|NCT00738075|Device|Auditory cue|When device recognizes automatically freezing episode it will generate auditory cue
16287153|NCT00738062|Drug|Droxidopa|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16287154|NCT00738062|Drug|Placebo|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16287155|NCT00738049|Drug|darusentan 100 mg|All subjects will receive oral darusentan 100 mg for a total of 2 weeks and placebo for 2 weeks.
16287156|NCT00738023|Drug|Rosiglitazone|Diabetic subjects will be receive rosiglitazone for 6 weeks
16287157|NCT00738023|Drug|Normal saline 0.9%|Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours
16287158|NCT00738023|Drug|Intralipid 20%|Intralipid 20% at 40ml/hr intravenously for 48 hours
16287159|NCT00738010|Device|Kneehab|Program of NMES 3 times per day, five days per week for 12 weeks.
16287160|NCT00738010|Device|Poli-Stim|Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.
16287161|NCT00738010|Behavioral|Control|Voluntary quadriceps muscle contractions.
16287162|NCT00737997|Drug|Morphine|150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia
16287163|NCT00737997|Other|Saline|10 ml saline alone
16287164|NCT00737984|Procedure|Endometrial sampling|Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle
16287165|NCT00737971|Drug|Bevacizumab intravitreal|Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
16287166|NCT00737971|Drug|Triamcinolone|Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
16287167|NCT00737971|Drug|Triamcinolone + Bevacizumab|Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8
16287168|NCT00737932|Drug|Laquinimod|Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
16287169|NCT00737932|Other|placebo|Matching placebo for 8 weeks of treatment
16287170|NCT00737919|Dietary Supplement|Plant Stanol|Plant stanols in margarines daily 2 grams
16287171|NCT00737919|Dietary Supplement|Plant Sterol|Plant sterols in margarines daily 2 grams
16287172|NCT00737906|Procedure|Surgical turbinate reduction procedure|Surgical turbinate reduction using the COBLATION device
16287173|NCT00737893|Drug|Placebo|Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
16287174|NCT00737893|Drug|Erythropoietin (EPO)|Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
16287175|NCT00737880|Other|Organ perfusion during pancreas procurement|Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
16287176|NCT00737867|Drug|Vinorelbine|Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
16287177|NCT00737867|Drug|Gemcitabine|Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
16287178|NCT00737867|Drug|Vinorelbine|Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
16287179|NCT00737867|Drug|Carboplatin|Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
16287180|NCT00737854|Procedure|Surgical resection|20 patients with OLP will be selected for this study. Before this routine treatment modalities had been attempted. Removal of possible triggering drug was also considered. Local ethical committee approval will be obtained before the trial starts. Surgical procedure includes: removal of the tissue up to submucosa (containing antigenic properties that caused OLP). A specimen will be sent for histopathologic analysis. The graft sliced from healthy mucosa also up to submucosa. Then the graft trimmed on a gauze soaked in saline and adapted to recipient site. The graft was sutured in position. Checking will be done after 1 week and every two months up to 1 year. Punch biopsy will be done in 1 year after surgery for histopathologic investigations.
16287181|NCT00737841|Drug|Bifidobacterium breve|1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
16287182|NCT00737841|Drug|Placebo|1.0 g of placebo, taking orally, 3 times a day for 8 weeks.
16287183|NCT00737828|Other|Perioperative care pathway guided by CPX results|"AT > 11ml/min/kg no myocardial ischaemia or Ve/VO2 <35 - Level 1 Ward Care
~AT > 11ml/min/kg with myocardial ischaemia or Ve/VO2 >35 - Level 2/3 (ITU) Critical Care Unit
~AT <11mls/min/kg - Level 2/3 Critical Care Unit
~AT <8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure"
16287184|NCT00737815|Dietary Supplement|Magnesium Citrate: a total of 500 mg elemental magnesium|500 mg elemental magnesium
16287185|NCT00737815|Other|Placebo|Inactive placebo pill
16287186|NCT00737789|Drug|Mesalazine slow-release granules|Mesalazine 2g Sachet prolonged release granules, administered orally.
16287187|NCT00737789|Drug|Mesalazine liquid enema|1g mesalazine liquid enema, administered topically once a day in the evening.
16287188|NCT00737776|Drug|biphasic insulin aspart 30|Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16287189|NCT00737763|Drug|efalizumab|Enrollees randomized to efalizumab will receive the first dose of 0.7mg/kg subcutaneously given at enrollment, and 1.0 mg/kg subcutaneously weekly for 26 weeks self or family-administered after injection training. This is the FDA-approved initial and subsequent doses of efalizumab used for psoriasis treatment
16287190|NCT00737763|Drug|placebo|Enrollees receiving placebo will be given a subcutaneous injection of equal volume and appearance to treatment on the same schedule.
16287191|NCT00737750|Device|Kneehab|Program of NMES 3 times per day, five days per week for 12 weeks.
16287192|NCT00737750|Device|Poli-Stim|Poli-Stim is standard NMES which the patients used for 20 minutes, 3 times per day, 5 days per week for 12 weeks.
16287193|NCT00737750|Behavioral|Control|Voluntary quadriceps muscle contractions.
16287194|NCT00737737|Drug|MS Contin|
16287195|NCT00737737|Drug|Placebo|
16287196|NCT00737724|Drug|Simultaneous ARV and antiMTB|Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
16287197|NCT00737724|Drug|Deferred RV and antiMTB treatment|Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy
16287198|NCT00737711|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|iv 0.6 micrograms/kg every 2 weeks
16287199|NCT00737698|Other|Exercise|Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
16287200|NCT00737698|Other|Repetitive magnetic stimulation|Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
16287201|NCT00737685|Drug|cyclophosphamide, fludarabine , thymoglobulin|cyclophosphamide (50 mg/kg once daily i.v. on days -9, -8, -7 & -6) fludarabine (30 mg/m2 once daily i.v. on days -5, -4, -3 & -2) thymoglobulin (2.5 mg/kg once daily i.v. on days -3, -2 & -1)
16287202|NCT00737672|Device|GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface|Deployment of investigational stent graft at the venous anastomosis
16287203|NCT00737672|Procedure|Percutaneous Transluminal Angioplasty|Percutaneous Transluminal Angioplasty at the venous anastomosis
16287204|NCT00737659|Drug|Mycophenolate mofetil (CellCept® )|Concentration Control group: MMF dosage will be adjusted (by addition or subtraction of least 250 mg of MMF twice a day) based on MPA levels (MPA AUC target of 40 mg*h\L) measured on Days 7,14,Months 1,3,6 and 12.
16287205|NCT00737659|Drug|Mycophenolate mofetil (CellCept® )|Fixed Dose group, MMF dosage will be adjusted based on standard care
16287206|NCT00737646|Behavioral|Usual care|No intervention will be conducted in this arm of the study.
16287286|NCT00736996|Behavioral|Endurance Exercise Training|Individualized exercise prescription, 45-75 minutes (progressive increments) three times a week
16287287|NCT00736983|Drug|adalimumab|24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks
16287288|NCT00736983|Drug|ciprofloxacin|12 weeks; daily 2 x 500mg
16287207|NCT00737646|Behavioral|Clinic-focused intervention|The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff. The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based. The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.
16287208|NCT00737646|Behavioral|Clinic- and patient-focused|This arm will combine the clinic-focused intervention and the patient-focused intervention. The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.
16287209|NCT00737633|Drug|VI-0521|Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
16287210|NCT00737620|Procedure|Prosthetic AV graft implantation|Surgical arteriovenous fistula creation with standard or propaten graft
16287211|NCT00737594|Drug|Placebo|Matching placebo capsules for oral administration
16287212|NCT00737594|Drug|Cobiprostone|Cobiprostone capsules for oral administration
16287213|NCT00737568|Drug|TDF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily
16287214|NCT00737568|Drug|FTC/TDF|Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily
16287215|NCT00737568|Drug|TDF Placebo|TDF placebo tablet administered orally once daily
16287216|NCT00737568|Drug|FTC/TDF Placebo|FTC/TDF placebo tablet administered orally once daily
16287217|NCT00737555|Drug|CHR-2797|Oral once daily administration of capsules of CHR-2797, to determine safety and tolerability in patients being treated with paclitaxel infusion every 3 weeks for up to 18 weeks.
16287218|NCT00737542|Drug|lidocaine|
16287219|NCT00737542|Drug|NACL 0.9%|
16287220|NCT00737529|Drug|lenalidomide|25mg oral capsules continuous days 1-21 each of a 28 day cycle
16287221|NCT00737516|Biological|HPC, Cord Blood|Search for HLA compatible cord blood units using the NMDP registry
16287222|NCT00737503|Biological|Rotavirus Vaccine (ROTARIX)|Rotavirus Vaccine two doses four weeks apart
16287223|NCT00737490|Other|"Sequential Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)"|"Echocardiographically guided optimized device programming: specifically sequential BiV pacing. Sequential Arm
~Using one of the FDA approved St. Jude devices, depending on MD preference."
16287224|NCT00737490|Other|"Simultaneous Arm (Promote , model # 2207-36 or Atlas HF , model # V-343)"|"simultaneous BiV pacing.
~Using one of the FDA approved St. Jude devices, depending on MD preference."
16287225|NCT00737477|Drug|Methoxy polyethylene glycol-epoetin beta|Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
16287226|NCT00737464|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
16287227|NCT00737451|Behavioral|blood sampling|blood sampling 10ml from the study subjects
16287228|NCT00737438|Drug|epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecan|"Patients with FDG avid locally advanced but resectable gastric or GEJ adenocarcinoma will receive preoperative therapy with epirubicin, cisplatin, capecitabine (ECX), and bevacizumab. Each cycle of therapy is 21 days. Near the completion of cycle 1 of therapy (eg during week 3, target days 18-21), patients will undergo a second FDG-PET/CT scan. Note, patients will hold capecitabine for 48 hours prior to the FDG-PET/CT scan.
~Patients with a good metabolic response (eg. > 35% reduction in FDG uptake at the primary tumor on the week 3 PET scan as compared with baseline FDG uptake) will continue ECX for 2 additional cycles (cycle 2 and 3).
~Cycle 2 will be administered with bevacizumab and cycle 3 will be administered without bevacizumab. Patients will then proceed to surgery approximately 4-6 weeks following the completion of cycle 3. There is a 10-12 week time interval (eg. 70-84 days) between the last bevacizumab treatment and surgery."
16287229|NCT00737425|Device|PainShield|
16287230|NCT00737425|Device|Sham PainShield|
16287231|NCT00737412|Other|Probiotic: Bio-K+ CL1285|The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
16287232|NCT00737412|Other|Placebo|Matching capsules devoid of microorganisms
16287233|NCT00737399|Behavioral|Lifestyle Counseling with Emotional Freedom Techniques (EFT)|Two series of four sessions of phone support group coaching instruction in the use of EFT
16287234|NCT00737373|Drug|Docetaxel|50mg/m2 qd15
16287235|NCT00737373|Drug|5-Fluorouracil|2600mg/m2 qd15
16287236|NCT00737373|Drug|Oxaliplatin|85mg/m2 qd15
16287237|NCT00737373|Drug|folinic acid|200mg/m2 qd15
16287238|NCT00737360|Drug|TAS-106|6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
16287239|NCT00737347|Behavioral|Lifestyle modification|lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
16287240|NCT00737334|Device|EEGo, BIS, FORE-SIGHT cerebral oximeter|"The EEGo monitor, BIS monitor, and FORE-SIGHT cerebral oximeter will be used for cerebral monitoring of all patients. A comparison of the three monitors will be done. For EEGo monitoring, five bipolar electrodes will be placed per International 1020 system. For BIS monitoring, the BIS quattro sensor will be placed on the forehead in usual fashion. For FORE-SIGHT monitoring, the two sensor strips will be placed on the forehead in usual fashion.
~All patients will have their ipsilateral Internal Jugular vein cannulated by the surgeon intraoperatively with a 16g IV cannula, through which a Portex multi-orifice epidural catheter will then be placed."
16287241|NCT00737321|Procedure|Samples will be collected|wound tissue biopsy, blood samples, saliva collection and wound VAC sponge (if applicable).
16287242|NCT00737308|Other|ceramic crown|Zirconia
16287289|NCT00736970|Drug|ridaforolimus|10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus.
16287290|NCT00736970|Drug|trastuzumab|single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes
16287243|NCT00737295|Procedure|CCK Injection and Ultrasound|"All subjects, whether they participate in this study or not, will undergo the HIDA scan as this is the accepted standard of care for diagnosing biliary dyskinesia. If a given subject agrees to participate in this study, he/she will be asked to undergo the following study procedures:
~If a pregnancy test has not already been done, a urine pregnancy test will be done for women of childbearing potential.
~An intravenous line (IV) will be inserted (if not already in place), and a standard dose of CCK (Kinevac®- 0.02 µg/kg) will then be injected according to the package insert. Ultrasound will be used to measure dimensions of the gallbladder (length, width and height) every minute for 35 minutes following injection of the CCK. This will be done by applying ultrasound jelly to the upper part of the abdomen and ultrasound probe will be used to obtain optimal images for three dimensional analysis of the subject's gallbladder."
16287244|NCT00737282|Drug|Proellex 25 mg|One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
16287245|NCT00737282|Drug|Proellex 50 mg|Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
16287246|NCT00737256|Drug|Aripiprazole|15-30 mg
16287247|NCT00737256|Drug|Perphenazine|8-16 mg
16287248|NCT00737243|Drug|Paclitaxel|175 mg/m2, 1-3 hour IV infusion Day 1
16287249|NCT00737243|Drug|Carboplatin|AUC 6.0 IV Day 1
16287250|NCT00737243|Drug|Bevacizumab|15 mg/kg IV infusion Day 1
16287251|NCT00737243|Drug|Erlotinib|150 mg PO
16287252|NCT00737243|Other|Treatment determined by physician|Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy
16287253|NCT00737230|Other|educational intervention|
16287254|NCT00737230|Other|questionnaire administration|
16287255|NCT00737230|Procedure|assessment of therapy complications|
16287256|NCT00737230|Procedure|gastrointestinal complications management/prevention|
16287257|NCT00737230|Procedure|management of therapy complications|
16287258|NCT00737230|Procedure|quality-of-life assessment|
16287259|NCT00737217|Behavioral|Behavioral assessment/questionnaire|Complete behavioral assessment/questionnaire
16287260|NCT00737204|Drug|Armodafinil|Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
16287261|NCT00737204|Drug|Placebo|Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
16287262|NCT00737191|Drug|olanzapine|Given orally
16287263|NCT00737191|Other|placebo|Given orally
16287264|NCT00737178|Device|CuT380A|Comparison of different timing of IUD insertion
16287265|NCT00737165|Behavioral|Multimodal suicide prevention program|"A community intervention of multimodal suicide prevention program includes following components:
~Building support networks for suicide prevention and mental health promotion in public health system
~Primary prevention of suicide and suicide related behaviors
~Secondary prevention of suicide and suicide related behaviors
~Tertiary prevention; after care for suicide survivors
~Suicide prevention targeting for people with substance/alcohol- related disorders , schizophrenia and other mental health disorders
~Suicide prevention targeting for people with work-related problems"
16287266|NCT00737165|Behavioral|Suicide prevention program as usual|Usual suicide prevention program
16287267|NCT00737152|Other|RAS 130 with diet and exercise|Entire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study.
16287268|NCT00737139|Procedure|Peri-articular injection of marcaine/epinephrine|60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj
16287269|NCT00737139|Procedure|Peri-articular injection of marcaine alone|60ml of 0.5% Bupivacaine
16287270|NCT00737126|Drug|Folic acid|Administration of a daily tablet containing 5 mg of folic acid for 4 months.
16287271|NCT00737126|Drug|Placebo|Administration of an oral placebo pill
16287272|NCT00737113|Drug|Genotropin (Recombinant Human Growth Hormone)|Patients will begin daily subcutaneous (SC) therapy at a starting dose of ~0.02mg/kg body weight. The study drug will continue for 90 days post enrollment.
16287273|NCT00737100|Drug|Placebo Respimat|patient to receive placebo matching active drug once daily
16287274|NCT00737100|Drug|Tiotropium bromide 5 mcg|patient to recieve high dose tiotropium once daily
16287275|NCT00737100|Drug|tiotropium bromide-low dose-2.5mcg|patient to receive low dose tiotropium once daily
16287276|NCT00737087|Device|Delta Xtend Reverse Total Shoulder|Orthopaedic implant for total shoulder replacement
16287277|NCT00737061|Device|Adiana Transcervical Sterilization System|Implantation of silicone matrix in fallopian tubes
16287278|NCT00737048|Drug|Tramadol Hydrochloride|Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).
16287279|NCT00737048|Drug|Acetaminophen|Acetaminophen two oral capsules will be administered once as 650 mg.
16287280|NCT00737048|Drug|Placebo|Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
16287281|NCT00737048|Drug|Tramadol plus Acetaminophen|Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.
16287282|NCT00737035|Behavioral|Interactive Healthcare Communication Application|"The IHCA is an Internet-based tool that integrates multiple resources for guardians of survivors of interparental homicide. The IHCA will have six components: (1) an instant library of articles on topics of interest; (2) a resource directory of both national and local support and service organizations; (3) access to a peer communication system; (4) a Frequently Asked Questions section, updated with responses to user generated questions; (5) an Ask an Expert system staffed by researchers; and (6) personal stories of others dealing with IPH."
16287283|NCT00737035|Behavioral|Control Web sites|Only publicly available Web sites on parenting, child development, and trauma will be used.
16287284|NCT00736996|Drug|Pioglitazone|30 - 45mg tablet daily for 6 months
16287285|NCT00736996|Drug|Placebo|Matching tablet daily for 6 months
16287335|NCT00736658|Drug|Placebo|Oral admin. of doses at 11 days through a 12 days period.
16287291|NCT00736957|Drug|Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.
16287292|NCT00736944|Drug|Abraxane|100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3
16287293|NCT00736944|Drug|Cetuximab|400 mg/m2 IVPB, Day 1, cycle 1
16287294|NCT00736944|Drug|Cetuximab|250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3
16287295|NCT00736944|Drug|Cisplatin|75 mg/m2 IVPB Day 1, cycles 1, 2 and 3
16287296|NCT00736944|Drug|5-FU|750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3
16287297|NCT00736944|Radiation|Radiation (Post induction)|Monday-Friday, weeks 1-7
16287298|NCT00736944|Drug|Cisplatin|(Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42
16287299|NCT00736944|Drug|Cetuximab|(Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB
16287300|NCT00736931|Drug|Brivaracetam|Brivaracetam 10 mg tablets
16287301|NCT00736931|Drug|levetiracetam|500mg tablets
16287302|NCT00736931|Drug|lorazepam|lorazepam 2 mg over encapsulated tablets
16287303|NCT00736931|Other|placebo|placebo capsules
16287304|NCT00736918|Behavioral|Case management|Case management, Usual clinical practice and Providing paper based information for suicide prevention
16287305|NCT00736918|Other|Enhanced usual care|Usual clinical practice and Providing paper based information for suicide prevention
16287306|NCT00736905|Drug|TMC278|
16287307|NCT00736879|Drug|Dapagliflozin|Tablets, Oral, Once Daily, Up to 24 weeks
16287308|NCT00736879|Drug|Placebo|Tablets, Oral, Once Daily, Up to 24 weeks
16287309|NCT00736866|Drug|Acetylcysteine|Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
16287310|NCT00736866|Drug|Placebo|Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
16287311|NCT00736853|Drug|Tramadol Hydrochloride Plus Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).
16287312|NCT00736853|Drug|Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.
16287313|NCT00736853|Drug|Placebo (Double-Blind)|Matching placebo will be given up to 4 weeks.
16287314|NCT00736840|Device|c13 methacetin solution with breath analyzer|Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver
16287315|NCT00736814|Drug|carboplatin|Given intravenously
16287316|NCT00736814|Drug|docetaxel|Given intravenously
16287317|NCT00736814|Drug|gemcitabine hydrochloride|Given intravenously
16287318|NCT00736814|Drug|vinorelbine tartrate|Given intravenously
16287319|NCT00736801|Drug|Salmeterol and Salmeterol / Fluticasone|Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.
16287320|NCT00736788|Drug|AZD1704|single dose oral suspension, 4 different dose levels
16287321|NCT00736788|Drug|Placebo|single dose oral suspension
16287322|NCT00736775|Drug|anti-Abeta|Intravenous single and multiple doses
16287323|NCT00736775|Drug|placebo|Intravenous single and multiple doses
16287324|NCT00736762|Other|GPR|The subjects randomised to the GPR program will participate in posture retraining techniques of approximately forty minutes, one time a week for ten weeks.
16287325|NCT00736749|Procedure|Assessment of Therapy Complications|Complete patient response form and Health Status Update Form
16287326|NCT00736749|Other|Questionnaire Administration|Complete patient response form and Health Status Update Form
16287327|NCT00736736|Other|Additional Hip Muscle Strengthening to Leg Press Exercise|
16287328|NCT00736736|Other|Leg Press Exercise|
16287329|NCT00736710|Procedure|Repetitive Transcranial Magnetic Stimulation (rTMS)|The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.
16287330|NCT00736710|Procedure|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.
16287331|NCT00736697|Drug|moxidectin|
16287332|NCT00736684|Device|Proximal Femoral Nail AntirotationTM (PFNA)|intramedullary nailing
16287333|NCT00736684|Device|Gamma Nail 3TM (Gamma3)|intramedullary nailing
16287334|NCT00736658|Drug|AZD1386|Oral admin. of doses at 11 days through a 12 days period.
16287336|NCT00736645|Dietary Supplement|selenomethionine|Given orally
16287337|NCT00736645|Drug|finasteride|Given orally
16287338|NCT00736645|Other|placebo|Given orally
16287339|NCT00736632|Drug|Vitamin D3|Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
16287340|NCT00736632|Drug|Placebo|Placebo pill orally daily Calcium carbonate 500 mg twice daily
16287341|NCT00736619|Other|Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)|"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity-modulated radiation therapy) administered concurrently with cetuximab (400 mg/m2 intravenous loading dose one week prior to radiation therapy, followed by 250 mg/m2 weekly intravenous infusions). To explore different dose levels of nanoparticle albumin-bound paclitaxel (Abraxane®) given intravenously weekly with the standard regimen of weekly cetuximab + daily radiation therapy.
~The total number of planned cetuximab infusions is 8 (loading dose, plus 7 weekly infusions concurrent with radiation therapy). The total number of planned albumin-bound paclitaxel infusions is 7 (all concurrent with radiotherapy). Five dose levels of weekly intravenous (IV) albumin-bound paclitaxel will be explored."
16287342|NCT00736606|Drug|simvastatin|One single dose of 40mg
16287343|NCT00736606|Drug|AZD9056 + simvastatin|AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
16287344|NCT00736593|Drug|Nexagon™ or Nexagon™ vehicle|
16287345|NCT00736580|Other|Blunt tipped needle|The Cesarean delivery is performed using blunt tipped needles.
16287346|NCT00736580|Other|Sharp needles|The cesarean is performed using standard sharp surgical suture needles.
16287347|NCT00736541|Drug|N-acetylcysteine|The patients in the NAC group will receive a loading dose of 140 mg/kg IV of NAC over one hour at the start of the surgery. Thereafter, NAC will be repeated every 4 hours at a dose of 70 mg/kg IV, for a total of 13 doses
16287348|NCT00736528|Drug|PF-04447943|05 mg BID for 14 days
16287349|NCT00736528|Drug|PF-04447943|15 mg BID for 14 days
16287350|NCT00736528|Drug|PF-04447943|45mg BID for 14 days
16287351|NCT00736528|Drug|Placebo|Placebo for 14 days
16287352|NCT00736515|Drug|Gliclazide MR and Insulin Glargine Injection|Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months
16287353|NCT00736515|Drug|Biosynthetic Human Insulin Injection|Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months
16287354|NCT00736489|Drug|AZD3199|Dry powder for inhalation, single dose
16287355|NCT00736489|Drug|Formoterol|Dry powder for inhalation, single dose
16287356|NCT00736489|Drug|Placebo|Dry powder for inhalation, single dose
16287357|NCT00736476|Biological|H.pylori vaccines|1 dose of H.pylori vaccine at 0, 1, and 2 months
16287358|NCT00736476|Biological|Placebo Vaccine|Placebo Vaccine at 0, 1, and 2 months
16287359|NCT00736463|Drug|Simvastatin|One arm of randomized crossover
16287360|NCT00736463|Drug|Atorvastatin 80 mg|Second arm of randomized crossover
16287361|NCT00736450|Biological|oblimersen sodium|Given IV
16287362|NCT00736450|Biological|rituximab|Given IV
16287363|NCT00736450|Drug|cyclophosphamide|Given IV
16287364|NCT00736450|Drug|doxorubicin hydrochloride|Given IV
16287365|NCT00736450|Drug|vincristine sulfate|Given IV
16287366|NCT00736450|Drug|prednisone|Given orally
16287367|NCT00736450|Procedure|biopsy|Correlative studies
16287368|NCT00736450|Genetic|microarray analysis|Correlative studies
16287369|NCT00736450|Other|immunohistochemistry staining method|Correlative studies
16287370|NCT00736450|Genetic|gene expression analysis|Correlative studies
16287371|NCT00736450|Genetic|cytogenetic analysis|Correlative studies
16287372|NCT00736437|Drug|ME-609|Cream applied topically 6 times daily over the UVR exposed area
16287373|NCT00736437|Drug|Vehicle|Treatment applied 6 times daily over the UVR exposed area
16287374|NCT00736424|Device|Itrel II™ and Soletra™ Epilepsy Control System|Bilateral neurostimulation of the anterior nucleus of the thalamus
16287375|NCT00736411|Procedure|acupuncture|16 treatments over 8 weeks
16287376|NCT00736411|Procedure|IVF|one 4 week IVF cycle
16287377|NCT00736398|Procedure|Spinal fusion|Spinal fusion
16287378|NCT00736385|Drug|Glucophage (Metformin)|metformin XR 2000 mg daily for 12 months
16287379|NCT00736385|Drug|Placebo|placebo 2000 mg daily for 12 months
16287380|NCT00736372|Drug|PX-12|Intravenous infusion, dose escalation, infused over a 72 hour period on days 1, 2 and 3 of a 21-day cycle until progression or development of unacceptable toxicity
16287381|NCT00736346|Behavioral|Brief cognitive-behavioral treatment for Panic Disorder|One two-hour session of cognitive-behavior therapy for panic disorder
16287382|NCT00736346|Behavioral|Cognitive-Behavior Therapy for Panic Disorder|Seven one-hour sessions of cognitive-behavior therapy for panic disorder
16287383|NCT00736346|Drug|paroxetine|40 mg die, for 6 months
16287384|NCT00736333|Drug|Pegylated Liposomal Doxorubicin|Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles
16287385|NCT00736320|Drug|ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)|chemotherapy with 2 cycles of ABVD (day 1 + 15)
16287386|NCT00736320|Radiation|20 Gy IFRT (Involved Field Radiotherapy)|20 Gy Involved Field Radiotherapy
16287387|NCT00736307|Procedure|Cultured limbal stem cells Transplantation|Transplantation of cultivated limbal epithelium on amniotic membrane
16287388|NCT00736294|Drug|Ramipril|5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
16287389|NCT00736294|Drug|Placebo|5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
16287424|NCT00735995|Behavioral|Cognitive behavioral therapy (group)|The Coping Cat program, 12 weekly sessions, two additional parent meetings
16287425|NCT00735969|Drug|Peginterferon|
16287426|NCT00735969|Drug|Ribavirin|
16287427|NCT00735956|Behavioral|Counseling|Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.
16287428|NCT00735943|Other|No intervention|No intervention
16287429|NCT00735930|Drug|Alvocidib Hydrochloride|Given IV
16287430|NCT00735930|Drug|Lenalidomide|Given PO
16287390|NCT00736281|Other|Food Drops: Food Allergens (peptides)|The patients enrolled in our study will present with food allergy symptoms and diagnostic tests will provide the specific information regarding their food allergies. Once the diagnosis has been made and consent for treatment has been obtained, participants will be randomly assigned to either the group that receives the food allergy intervention with SLIT ( food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT (glycerin only). The patients are truly blinded to their treatment because all the SLIT food allergy vials are identical and contain no distinguishing features that could reveal their contents. There is also no difference in taste between a vial containing glycerin and food allergens and a vial containing only glycerin.
16287391|NCT00736268|Behavioral|Telephone-based Enhanced Coping Skills Training (CST)|Telephone-based Enhanced Coping Skills Training (CST) intervention will systematically train participants (and caregivers) in the use of coping skills for symptom management (i.e. activity pacing, pleasant activity scheduling, communications, relaxation, goal setting, imagery, calming self-statements, problem solving, and preventing and dealing with setbacks). Participants in the CST condition will receive 12 weekly 30 minute telephone sessions followed by 2 bi-weekly booster sessions for training in symptom management strategies. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.
16287392|NCT00736268|Other|Usual Medical Care and COPD education and symptom monitoring (UMC)|COPD usual care plus education and symptom monitoring control condition will participate in a weekly 15 minute phone call followed by 2 bi-weekly phone calls, assessing their health status and providing them with support and COPD education. COPD Education topics include types of lung disease, oxygen use, medication management, preventing infection, managing daily activities, and nutrition. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.
16287393|NCT00736255|Drug|Transdermal Nicotine Patch|All subjects will lreceive transdermal nicotine patch during beginning at Visit 0 (quit smoke date). The dose will be tapered down from 21 mg to 14mg after week 1,vthen to 7 mg after week 2. Subjects will remain at 7mg until the 4th week.
16287394|NCT00736255|Drug|Lis-dexamphetamine (Vyvanse)|Subjects on this arm will receive Lis-dexamphetamine day after the identified quit date. All subject will start with 30mg once a day and will be titrated up to 50mg then to 70mg over a 3 week period to reach an optimized dose. They will then be maintained on this optimized dose until the 4th week.
16287395|NCT00736255|Drug|Placebo|Subjects on this arm will receive matching placebo, along with Nicotine Replacement Therapy.
16287396|NCT00736242|Biological|PEG-IFN alfa-2b|Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling
16287397|NCT00736242|Drug|RBV|Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling
16287398|NCT00736229|Drug|Exenatide|0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
16287399|NCT00736216|Other|survey administration|Participants complete the Young Adult Survey online documenting demographic data; sexual history (i.e., whether they ever had sex, age of first sexual encounter, number of life time partners, condom use, sexually transmitted diseases [STDs], and pregnancy history); cigarette use; current and past drug use; knowledge of human papillomavirus (HPV) and cervical cancer; past history of Pap tests and STD screenings; attitudes towards HPV testing; vaccine knowledge and acceptability; sources of information about HPV; source of information about cervical cancer; identification of common STDs; perceived risk of acquiring STDs; perceived risk of acquiring HPV; social support; and religion.
16287400|NCT00736190|Drug|Tenofovir disoproxil fumarate|300-mg tablet (marketed formulation) taken orally once daily
16287401|NCT00736177|Procedure|Embryo cryopreservation|Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.
16287402|NCT00736177|Procedure|Fresh embryo transfer|Subjects in the Control group will receive fresh embryo transfer.
16287403|NCT00736164|Dietary Supplement|selenomethionine|Given orally
16287404|NCT00736164|Other|placebo|Given orally
16287405|NCT00736151|Drug|Ralfinamide|Oral tablets administered at rising doses of 80 - 320 mg/day
16287406|NCT00736138|Procedure|training and pellots|training and pellots
16287407|NCT00736125|Device|pulsatile saline lavage|Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
16287408|NCT00736125|Device|carbon dioxide lavage|Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
16287409|NCT00736112|Other|Food Allergy Testing|Food Allergy Diagnosis - blood drawn for food allergy testing at the time of surgery (bilateral myringotomy with tympanostomy tubes +/- adenoidectomy)
16287410|NCT00736112|Procedure|Adenoidectomy|Adenoidectomy to remove adenoid tissue. (Are adenoids a factor in OME (otitis media with effusion) or is food allergy diagnosis and treatment able to significantly prevent ROM (recurrent otitis media) after the tubes fall out?)
16287411|NCT00736112|Procedure|BMT|The standard protocol for children presenting with initial Chronic OME is to perform a BMT
16287412|NCT00736099|Drug|linagliptine 5 mg|safety and efficacy of linagliptine 5 mg open label
16287413|NCT00736099|Drug|linagliptine 5 mg and pioglitazone 30 mg|efficacy and safety of the combination linagliptine and pioglitazone
16287414|NCT00736086|Device|Vessel Closure (StarClose™)|
16287415|NCT00736073|Drug|aprepitant|one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
16287416|NCT00736073|Drug|Placebo|one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
16287417|NCT00736060|Other|Observational|Summary of clinical and laboratory data
16287418|NCT00736047|Biological|NIC002|
16287419|NCT00736047|Biological|Placebo|
16287420|NCT00736034|Dietary Supplement|Phosphatidylserine-Omega3 (SharpPS™-Gold)|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks
16287421|NCT00736021|Drug|Escitalopram|Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily
16287422|NCT00736008|Other|Observational|Data summary only
16287423|NCT00735995|Behavioral|Cognitive behavioral therapy (individual)|The Coping Cat program, 12 weekly sessions, two additional parent meetings
16287431|NCT00735930|Other|Pharmacological Study|Correlative studies
16287432|NCT00735930|Other|Laboratory Biomarker Analysis|Correlative studies
16287433|NCT00735917|Drug|saracatinib|Given PO
16287434|NCT00735917|Other|pharmacogenomic studies|Optional correlative studies
16287435|NCT00735917|Other|pharmacological study|Optional correlative studies
16287436|NCT00735917|Procedure|positron emission tomography|Optional correlative studies
16287437|NCT00735917|Radiation|fludeoxyglucose F 18|Optional correlative studies
16287438|NCT00735917|Other|laboratory biomarker analysis|Optional correlative studies
16287439|NCT00735904|Drug|AG-013736|AG-013736 5 mg tablets orally, twice daily, until disease progression
16287440|NCT00735904|Drug|gemcitabine|200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles
16287441|NCT00735904|Drug|cisplatin|1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles
16287442|NCT00735878|Drug|ABT-751 and Carboplatin|This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.
16287443|NCT00735865|Procedure|Punctal plugs, punctal cautery|25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin & tarsal/inferior fornix conjunctiva obtained & plated according to protocol
16287444|NCT00735865|Procedure|Punctal Plug, Punctal thermocauterization|"Up to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization.
~This group ONLY, cultures will be obtained of the lid margin & conjunctiva/inferior fornix of BOTH eyes"
16287445|NCT00735865|Procedure|Silicone plug or thermodynamic hydrophobic acrylic plug|"Up to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion.
~In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes"
16287446|NCT00735865|Other|Previous subjects with Punctal occlusion|"Up to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion.
~Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol."
16287447|NCT00735852|Drug|Decapeptyl SR 11.25mg|11.25 mgs, Intra muscular (IM) every 3 months for 2 years
16287448|NCT00735839|Biological|V710|V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
16287449|NCT00735839|Biological|Placebo|Saline placebo (0.5 ml) single injection on Day 1
16287450|NCT00735826|Drug|Vorinostat|Vorinostat will be administered orally once daily in an open-labeled, unblinded manner to all subjects enrolled in the study. Subjects will receive vorinostat 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection. Vorinostat should be taken with food within 0 to 30 minutes of a meal if possible. Patients should take the medication at approximately the same time each day on an ongoing basis. Missed doses will not be made up.
16287451|NCT00735813|Device|Taurolock|When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.
16287452|NCT00735813|Device|Heparin|When not in use the childrens tunneled central venous catheters are locked with heparin
16287453|NCT00735800|Behavioral|Family Intervention:Telephone Tracking Support- Caregiver|Family-based problem solving treatment
16287454|NCT00735800|Behavioral|Telephone Support|Supportive telephone counseling about caregiving
16287455|NCT00735787|Biological|Placebo|Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
16287456|NCT00735787|Biological|Adalimumab|Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
16287457|NCT00735774|Drug|11C-ORM-13070|Single dose of i.v. solution
16287458|NCT00735761|Drug|ME-609|Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
16287459|NCT00735761|Drug|Acyclovir in ME-609 vehicle (5% acyclovir)|Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
16287460|NCT00735748|Drug|Tramadol per os (Tradonal Odis® orodispersible tablets)|Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
16287461|NCT00735748|Drug|Tramadol IV (Tradonal® IV)|Administration of tramadol IV given in 3 unit dosage of 35 mg
16287462|NCT00735735|Other|The taking of a saliva sample from each subject.|After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis.
16287463|NCT00735722|Device|HIFU AF Ablation|Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
16287464|NCT00735709|Drug|Vortioxetine|Encapsulated immediate-release vortioxetine tablets
16287465|NCT00735709|Drug|Placebo|Vortioxetine placebo-matching capsules
16287466|NCT00735696|Biological|Ramucirumab|10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.
16287467|NCT00735696|Drug|Paclitaxel|200 milligrams per meter squared (mg/m^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.
16287468|NCT00735696|Drug|Carboplatin|Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.
16287508|NCT00735436|Drug|Gliadel/Avastin/CPT-11|
16287469|NCT00735683|Drug|ATHX-105 phosphate|includes diet, physical activity, and lifestyle modification
16287470|NCT00735683|Drug|Placebo|includes diet, physical activity, and lifestyle modification
16287471|NCT00735670|Drug|Venlafaxine HCl|Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug
16287472|NCT00735670|Other|Placebo|Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
16287473|NCT00735657|Device|needle|Peribulbar blockade with standard (25 mm) needle
16287474|NCT00735657|Device|needle|Peribulbar blockade with short (12.5 mm) needle
16287475|NCT00735657|Procedure|Pars Plana Vitrectomy|Peribulbar block
16287476|NCT00735644|Biological|Japanese encephalitis vaccine|0.5 mL, Subcutaneous
16287477|NCT00735644|Biological|Japanese encephalitis vaccine|0.5 mL, Subcutaneous
16287478|NCT00735644|Biological|Japanese encephalitis vaccine|0.5 mL, Subcutaneous
16287479|NCT00735644|Biological|Japanese encephalitis vaccine (Acambis)|0.5 mL, Subcutaneous
16287480|NCT00735644|Biological|Hepatitis A vaccine|0.5 mL, Intramuscular
16287481|NCT00735631|Device|SISO model-based predictive closed-loop system|The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
16287482|NCT00735618|Other|Guided Relaxation|Following 5 minute questionnaire, 15 minute rest and 5 minute heart rhythm recording, 15 minute relaxation program (listening via headphone to audio recording) to be completed by second heart rhythm recording and same questionnaire. Entire procedure 45-60 minutes.
16287483|NCT00735605|Other|BFD|The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
16287484|NCT00735605|Procedure|PDPR|A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain
16287485|NCT00735605|Other|BTX A|A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient
16287486|NCT00735592|Other|Observational|Retrospective data obtained from electronic files
16287487|NCT00735553|Drug|Proellex|One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
16287488|NCT00735553|Drug|Proellex|Two 25 mg mg capsules of Proellex® orally daily for up to four months
16287489|NCT00735553|Drug|Placebo|Two placebo capsules orally daily for up to four months
16287490|NCT00735540|Other|Observational|Data summary only
16287491|NCT00735527|Drug|Lorazepam|Intra-nasal 0.1 mg/kg (maximum 4 mg) once
16287492|NCT00735527|Drug|Lorazepam|Intra-venous 0.1 mg/kg (maximum 4 mg) once
16287493|NCT00735514|Behavioral|compliance monitoring|Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
16287494|NCT00735514|Other|questionnaire administration|Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
16287495|NCT00735514|Procedure|assessment of therapy complications|Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
16287496|NCT00735514|Procedure|management of therapy complications|Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
16287497|NCT00735514|Procedure|psychosocial assessment and care|Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
16287498|NCT00735501|Drug|insulin detemir|Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
16287499|NCT00735488|Other|Observational|Summary of data
16287500|NCT00735475|Biological|CSL Limited Influenza Virus Vaccine (Afluria®)|A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
16287501|NCT00735475|Biological|US Licensed Influenza Virus Vaccine (Fluzone®)|A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
16287502|NCT00735462|Drug|2.5% imiquimod cream|2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
16287503|NCT00735462|Drug|3.75% imiquimod cream|3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
16287504|NCT00735462|Drug|Placebo cream|Placebo cream applied daily to wart areas for up to 8 weeks
16287505|NCT00735449|Drug|Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%|1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
16287506|NCT00735449|Drug|timolol maleate 0.5%|1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
16287507|NCT00735449|Drug|latanoprost 0.005%|1 drop of latanoprost 0.005% once nightly.
16287509|NCT00735423|Device|No intervention|IDE used for outcome measurement not intervention
16287510|NCT00735410|Biological|Seasonal Influenza Vaccine|1 dose of Split influenza vaccine
16287511|NCT00735397|Drug|perampanel|Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
16287512|NCT00735371|Drug|LDX 30 mg|Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
16287513|NCT00735371|Drug|LDX 50 mg|Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
16287514|NCT00735371|Drug|LDX 70 mg|Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
16287515|NCT00735371|Drug|Placebo|Placebo will be identical to test product.
16287516|NCT00735358|Procedure|Cyanoacrylate|Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot
16287517|NCT00735358|Procedure|Cyanoacrylate|Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
16287518|NCT00735345|Drug|5-FU|750 mg/m2/d C.I. i.v.d1-5, d29-33 and 300 mg/m2/d C.I. i.v. on the days of radiotherapy
16287519|NCT00735345|Drug|Cisplatin|15 mg/m2/d i.v. d1-5, d29-33
16287520|NCT00735345|Drug|Taxotere|75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78
16287521|NCT00735345|Biological|Cetuximab|Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
16287522|NCT00735345|Radiation|Radiation during chemoradio-immunotherapy|39.6 Gy total dose
16287523|NCT00735332|Drug|TLN-232|21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
16287524|NCT00735319|Device|Transcutaneous Bilirubinometer|For all eligible babies living in the 7 intervention community health centers, a Transcutaneous Bilirubinometer will be routinely used by all community nurses in conjunction with an algorithm that will guide the nursing management of the neonates based on the values obtained
16287525|NCT00735306|Drug|Avastin|Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
16287526|NCT00735306|Drug|Tarceva|Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
16287527|NCT00735306|Radiation|Radiation Therapy|Radiation to the pancreas Monday through Friday for 28 treatments
16287528|NCT00735293|Device|VASER|A small incision will be made in the underarm. A VASER probe will be inserted under the skin to break apart fat and sweat glands under the skin. A small hollow tube will be used to draw out the broken-down skin and the incision will be closed with a stitch.
16287529|NCT00735280|Drug|unfractionated heparin|bolus of 100 U/kg of unfractionated heparin
16287530|NCT00735267|Drug|PD 0332334|Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
16287531|NCT00735254|Device|pulsed dye laser|patient will have scar treated with pulsed dye laser
16287532|NCT00735254|Device|Affirm Laser|patient will have scar treated with Affirm laser
16287533|NCT00735254|Device|combined PDL and Affirm Lasers|patient will have scar treated with Affirm and pulsed dye lasers
16287534|NCT00735254|Other|Placebo|patient will receive no treatment
16287535|NCT00735241|Device|SIR-Spheres microspheres|SIR-Spheres yttrium-90 microspheres
16287536|NCT00735241|Drug|FOLFOX6 cycles 1-3|Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
16287537|NCT00735241|Drug|FOLFOX6 cycles 4 onwards|Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
16287538|NCT00735241|Drug|Bevacizumab cycles 3 onwards|Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
16287539|NCT00735228|Device|Artificial pancreas|Artificial endocrine pancreas (NIKKISO Company)
16287540|NCT00735189|Other|anticoagulation clinic care|Patient receives care from the outpatient anticoagulation management service
16287541|NCT00735189|Other|usual care|patient receives usual anticoagulation care from their regular primary care physician
16287542|NCT00735176|Procedure|Cervical arthroplasty|Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
16287543|NCT00735176|Procedure|Anterior cervical discectomy and fusion (ACDF)|Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
16287544|NCT00735163|Other|enhanced model predictive control algorithm (eMPC)|eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control
16287545|NCT00735150|Behavioral|questionnaire, interview|You will be asked to make a one-time visit to MSKCC. At that research visit, you will be asked to complete a short questionnaire about your knowledge of various reproductive technologies relevant to individuals at hereditary risk. Then you will watch a short presentation about these reproductive technologies and complete a second brief questionnaire to assess your understanding of the presentation. Afterwards, you will meet with an interviewer one-on-one for about one hour, during which time you may share your thoughts and feelings about the use of these reproductive technologies.
16287546|NCT00735137|Device|Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)|Inserted from randomization till 36-37 weeks of gestation
16287547|NCT00735124|Drug|Gabapentin|1200 mg single dose gabapentin
16287548|NCT00735124|Other|placebo|Injection of placebo/sham
16287549|NCT00735111|Other|Karnofsky Performance Status Score|Karnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit.
16287550|NCT00735098|Other|KBA exercise|KBA exercise protocol, 3 times per week for 8 weeks
16287551|NCT00735098|Other|strength training exercise|strength training exercise, 3 times per week for 8 weeks
16287552|NCT00735098|Other|KBA and strength training|KBA and strength training exercise, 3 times per week for 8 weeks
16287553|NCT00735098|Other|Control group|8 week control group
16287554|NCT00735085|Drug|SLV334|1000mg SLV334 as a single dose
16287555|NCT00735085|Drug|SLV334|1000mg SLV334 b.i.d. for one day
16287556|NCT00735085|Drug|SLV334|2000mg SLV334 b.i.d. for one day
16287557|NCT00735085|Drug|SLV334|2000mg SLV334 b.i.d. for three days
16287558|NCT00735085|Drug|Placebo|SLV334 Placebo arm
16287559|NCT00735072|Drug|Placebo|Dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens.
16287560|NCT00735072|Drug|Maraviroc|Dose based on current medications in regimen: 150mg orally (PO) twice daily (BID) for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens.
16287561|NCT00735059|Device|treatment with the dialyzer ELISIO 170H|one week of three consecutive dialysis treatments, > 3 hours
16287562|NCT00735059|Device|treatment with the dialyzer PES-170DS|one week of three consecutive dialysis treatments, > 3 hours
16287563|NCT00735046|Behavioral|Cognitive behavioral therapy for early Alzheimer's disease|12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session. Intervention is manualized but is flexible with regard to individual resources and needs.
16287564|NCT00735046|Other|Control|Patients and proxies who are assigned to treatment as usual
16287565|NCT00735033|Other|Physiotherapy with Swiss Ball|
16287566|NCT00735020|Biological|Adjuvanted Influenza Vaccine|1 dose of Adjuvanted Influenza Vaccine
16287567|NCT00735020|Biological|Influenza Vaccine|1 dose of Influenza Vaccine
16287568|NCT00735007|Drug|Rebif® New Formulation (RNF) using RebiSmartTM|RNF 44 mg, 3 times a week by subcutaneous injection.
16287569|NCT00734994|Device|Hyperthermia System|Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence
16287570|NCT00734994|Drug|Mitomycin C|40 mg in 40 ml sterile water instilled into bladder
16287571|NCT00734968|Drug|Nitrofurantoin|Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
16287572|NCT00734968|Other|Placebo|6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
16287573|NCT00734955|Device|49-channel optical spectrometer|
16287574|NCT00734942|Other|support service|"professional partners for communication
~befriending with other families concerned
~information and education (about illness, symptoms, first aid, caring)
~free-time activities and time out
~homework assistance
~administrative advise
~support for everyday life"
16287575|NCT00734929|Drug|Aprepitant + Dexamethasone|Aprepitant 40 mg + Dexamethasone 10 mg
16287576|NCT00734929|Drug|Ondansetron + Dexamethasone|Ondansetron 4 mg + Dexamethasone 10 mg
16287577|NCT00734916|Dietary Supplement|Parenteral lipid emulsion (Omegaven)|Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
16287578|NCT00734916|Dietary Supplement|Parenteral lipid emulsion (Intralipid)|Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
16287579|NCT00734916|Dietary Supplement|Parental lipid emulsion (Saline 0.9%)|Placebo (Saline 0.9%), same volume/hr as lipid emulsions
16287580|NCT00734903|Behavioral|A Woman's Path to Recovery|WPR is a gender-specific therapy model for women with substance use disorder. It uses A Woman's Addiction Workbook to provide education and coping skills. In this trial it was conducted in 12 weekly individual sessions.
16287581|NCT00734903|Behavioral|12-Step Facilitation|12SF is an evidence-based therapy designed to facilitate early recovery from substance addiction. It is an individual model consisting of 12 sessions that use the principles of 12-step groups such as Alcoholics Anonymous, and strongly emphasizes participation in those. In this trial the model was conducted weekly.
16287582|NCT00734890|Biological|bevacizumab|
16287583|NCT00734890|Drug|vandetanib|
16287584|NCT00734890|Other|laboratory biomarker analysis|
16287585|NCT00734890|Other|pharmacological study|
16287586|NCT00734877|Drug|M-VTD-PACE|2 cycles of induction therapy with M-VTD-PACE and PBSC collection after the 1st cycle. MEL-based tandem transplant will be administered 6 weeks to 3 months apart, applying single dose MEL 200 mg/m2 with adjustments for age and renal function. Consolidation will consist of 2 cycles of dose-reduced VTD-PACE. Maintenance treatment will employ VRD for 3 years.
16287587|NCT00734877|Drug|TT3-LITE Regimen (L-TT3)|The TT3-LITE Regimen (L-TT3) will employ only 1 cycle of induction therapy with MVTD-PACE and, as in S-TT3, PBSC collection following recovery from this one and only induction treatment. MEL-based tandem transplant will be administered 6 weeks to 3 months apart, applying fractionated MEL200mg/m2 in 4 successive daily fractions of 50mg/m2 (MEL50 x 4) with addition of VTD with adjustments for age and renal function. Consolidation will consist of only 1 cycle of dose-reduced VTD-PACE. Maintenance treatment will employ VRD for 3 years.
16287588|NCT00734864|Drug|enzyme-inducing anti-epileptic drugs|Subjects taking EIAEDs (CYP3A enzyme-inducing anti-epileptic drugs Phenytoin/Dilantin, Fosphenytoin/Cerebyx, Phenobarbital, Primidone/Mysoline, Oxcarbazepine/Trileptal, Carbamazepine/Tegretol).
16287589|NCT00734864|Drug|enzyme-inducing anti-epileptic drugs|Subjects NOT taking EIAEDs (CYP-3A enzyme-inducing anti-epileptic drugs Phenytoin/Dilantin, Fosphenytoin/Cerebyx, Phenobarbital, Primidone/Mysoline, Oxcarbazepine/Trileptal, Carbamazepine/Tegretol).
16287590|NCT00734851|Drug|Docetaxel|Docetaxel 70 mg/m2 day 1 every 3 weeks for 4 cycles with prednisone 5 mg orally twice daily
16287591|NCT00734851|Drug|Sunitinib|Sunitinib 37.5 mg orally once daily for 14 days followed by 7 days off, for 4 cycles, concurrent with docetaxel and prednisone
16287592|NCT00734851|Radiation|EBXRT|External beam radiotherapy to the prostate bed, started on day 100, after completion of chemotherapy. 66 Gy over 6-7 weeks.
16287593|NCT00734838|Device|High Resolution Microendoscope|Using core biopsy and reduction mammoplasty tissue
16287594|NCT00734825|Other|Omnipaque|oral contrast for CT scan
16287595|NCT00734812|Procedure|Laparoscopic supracervical hysterectomy|Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
16287596|NCT00734812|Procedure|Total laparoscopic hysterectomy|Patients will be randomized to either removal or retention of cervix
16287597|NCT00734799|Behavioral|Sleep Intervention for PTSD (SIP).|"Patients in the SIP condition will receive the same elements as the Usual Care patients. In addition, these patients will receive six, bi-weekly, 1-hour individual sessions with the PI, including 3 sessions of Cognitive-Behavioral Therapy for Insomnia (CBT-I) and 3 sessions of Imagery Rehearsal Therapy (IRT). CBT-I consists of education designed to correct unrealistic sleep expectations, a prescription for an individually-tailored behavioral regimen, standard sleep hygiene recommendations, and the identification and restructuring of dysfunctional beliefs and attitudes regarding sleep. IRT is a brief intervention designed to facilitate the patient's rescripting of reoccurring nightmares to decrease their associated affective distress."
16287598|NCT00734786|Other|Wrinkle cream application|Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.
16287599|NCT00734773|Biological|Rituximab|Infusion will be given at week 2, week 4, week 6 and week 8. Infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
16287600|NCT00734773|Drug|Cytarabine|Administered by IV over 3 hours at a dose of 3 g/m2/day for 2 days given at week 17 and week 21.
16287601|NCT00734773|Drug|Methotrexate|Administered by IV at dose of 3.5 grams/m2 on day 1 of week 1, week 3, week 5, week 7 and week 9; if CSF was positive it will also be given intrathecally on day 8 of week 1, week 3, week 5, week 7 and week 9.
16287602|NCT00734773|Drug|Motexafin gadolinium|"Administered to the first five patients enrolled on trial, MGd will be given at 5 mg/kg q day x2 doses (completed on 2 consecutive days 1 to 2 weeks prior to day of cycle 1) to be followed by a non-infused MRI (without contrast) 1-5 hours after 2nd MGd dose (to evaluate for MGd tumor selective uptake).
~For induction chemotherapy, MGd 10 mg/kg will be given intravenously on day 8 of each cycle. MGd will be given immediately after Rituxan.
~During radiation therapy, MGd will be administered at 5 mg/kg 2-5 hours prior to WBRT, daily for the first 10 days (fractions) and then every other day of radiation thereafter."
16287603|NCT00734773|Drug|Procarbazine hydrochloride|Taken orally, 100 mg/m2 days 1-7 of the 1st, 3rd, and 5th cycles of induction therapy.
16287604|NCT00734773|Drug|Vincristine sulfate|Administered by IV at a dose of 1.4mg per meter squared on weeks 1, 3, 5, 7 and 9.
16287605|NCT00734773|Radiation|Radiation therapy|Given at weeks 11 through 16.
16287606|NCT00734760|Behavioral|education|face-to-face education and counseling intervention
16287607|NCT00734747|Device|Medigus SRS endoscopic stapling system|The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location.
16287608|NCT00734734|Biological|Seasonal Influenza Vaccine|1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation
16287609|NCT00734721|Behavioral|Preoperative information and perioperative care|Patients receive different information and care in addition to the basic medical consultation.
16287610|NCT00734708|Drug|Trafermin (genetical recombination)|Administered to the bone defect during flap operation
16287611|NCT00734708|Drug|Placebo|Control
16287612|NCT00734695|Dietary Supplement|vitamin c|Subconjunctival daily or bid
16287613|NCT00734695|Dietary Supplement|vitamin c|topical and systemic
16287614|NCT00734695|Dietary Supplement|vitamin c|topical systemic
16287615|NCT00734682|Drug|Nanoliposomal CPT-11|Depending on UGT1A1 genotyping status, patients are either given a starting dose of 120 mg/m^2 (wild type) or 60 mg/m^2 IV q3 weeks.
16287616|NCT00734669|Drug|Glibenclamide|Taking a single dose of 3.5 mg glibenclamide
16287617|NCT00734656|Drug|dutasteride + ethanol|4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes
16287618|NCT00734656|Drug|placebo medication + ethanol|placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes
16287619|NCT00734656|Drug|dutasteride + placebo alcohol|4 mg dutasteride administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes
16287620|NCT00734656|Drug|placebo medication + placebo alcohol|placebo medication administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes
16287621|NCT00734630|Drug|nebivolol|"Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
~Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration"
16287622|NCT00734630|Drug|Placebo|Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
16287623|NCT00734617|Drug|Nicotine Patch|"Groups 1 & 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day
~Groups 2 & 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day"
16287624|NCT00734604|Drug|tadalafil once a day [T(OaD)]|5 mg tablet taken once a day (OaD) by mouth for 8 weeks
16287625|NCT00734604|Drug|sildenafil citrate as needed [S(PRN)]|100 mg tablet taken as needed (PRN) by mouth for 8 weeks
16287626|NCT00734604|Drug|tadalafil as needed [T(PRN)]|20 mg tablet taken as needed (PRN) by mouth for 8 weeks
16287627|NCT00734591|Drug|Exubera|Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
16287628|NCT00734591|Other|Randomized diabetes therapy|"Subjects who had been treated with a comparator (other diabetes treatment including one or more of: subcutaneous insulin, sulfonylureas, biguanides, or thiazolinediones) in a prior Exubera controlled trial.
~Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice)."
16287629|NCT00734578|Drug|SPD503-AM|SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
16287630|NCT00734578|Drug|SPD503-PM|SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
16287631|NCT00734578|Drug|Placebo|Placebo matched to Guanfacine Hydrochloride Extended Release
16287632|NCT00734565|Biological|Haemophilus influenzae type b|1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months
16287633|NCT00734552|Dietary Supplement|α-Keto Acid with low protein diet|"Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day.
~Low Protein Diet: Diet contain protein 0.8g/kg/d."
16287634|NCT00734552|Dietary Supplement|Normal protein diet|Diet contain protein 1.0-1.2 g/kg/d.
16287635|NCT00734539|Drug|fluconazole|6mg/kg IV/PO twice weekly for a total of up to 12-13 doses
16287636|NCT00734539|Drug|placebo|normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses
16287637|NCT00734526|Drug|Temozolomide|"Groups 1 & 2: 75 mg/m^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles.
~Groups 3 & 4: 75 mg/m^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle."
16287638|NCT00734526|Radiation|Radiation|Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
16287639|NCT00734526|Drug|Sorafenib|"Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.
~Group 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.
~Group 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth.
~Group 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth."
16287640|NCT00734513|Behavioral|Partner-assisted emotional disclosure|Patients and partners in the partner-assisted emotional disclosure condition will attend four weekly face-to-face sessions with a therapist. The first session will last 75 minutes and will focus on training in skills to facilitate the patient's disclosure. The subsequent 3 sessions will last 45 minutes each. In these sessions, the therapist will briefly review the strategies and provide feedback from the previous session and the patient will spend 30 minutes talking about their cancer-related concerns to the partner.
16287641|NCT00734513|Behavioral|Cancer Education|The cancer education protocol consists of four weekly face-to-face sessions for education about living with GI cancer. The cancer education sessions will be delivered to patients and their partners and use a presentation and discussion format. Handouts and discussion sessions will center on the following topics: Orientation to Duke Cancer Care and the treatment team; suggestions for communicating with health care providers; resources for health information, psychosocial support, and financial concerns; evaluating health information on the internet; the impact of cancer on different domains of quality of life; and suggestions for maintaining quality of life.
16287642|NCT00734500|Drug|Anidulafungin|Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
16287643|NCT00734474|Drug|LY2189265|
16287644|NCT00734474|Drug|Sitagliptin|
16287645|NCT00734474|Drug|Placebo solution|
16287646|NCT00734474|Drug|Placebo tablet|
16287647|NCT00734474|Drug|Metformin|
16287648|NCT00734461|Drug|oxycodone and naltrexone|"tablets containing 20 mg or 40 mg oxycodone
~/ tablets containing 20 mg or 40 mg oxycodone combined w/0.001 mg or 0.0001 mg naltrexone"
16287649|NCT00734448|Dietary Supplement|myo-inositol|2 g twice a day until delivery
16287650|NCT00734435|Drug|zonisamide SR plus olanzapine|zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
16287651|NCT00734435|Drug|Placebo plus olanzapine|Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
16287652|NCT00734422|Behavioral|Virtual Reality Exposure Therapy|Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.
16287653|NCT00734409|Device|Bispectral Index (BIS) Monitor|BIS monitoring in addition to RASS assessments
16287654|NCT00734396|Procedure|Mesenchymal stem cell infusion|MSC infusion: two doses of 1-2x106 MSCs per kilogram body weight, intravenously, 7 days apart.
16287655|NCT00734383|Drug|Propofol|Propofol cardioprotection : Ten minutes prior to initiation of CPB, we will stop delivery of isoflurane, inject 1 mg/kg iv and then continuously infuse propofol at 120µg/kg/min IV until 15 min after release of the aortic cross clamp (reperfusion).
16287656|NCT00734383|Drug|Propofol|Volatile Anesthetic preconditioning : Anesthesia will be maintained using an inspired concentration of isoflurane between 0.5-2% before, during, and after CPB, without administration of propofol. For ten minutes prior to the initiation of CPB we will deliver Isoflurane 2.5% end tidal then resume maintenance anesthesia as described.
16287657|NCT00734370|Behavioral|Virtual Reality Exposure Therapy for agoraphobic participants|"This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of
~Psycho-education, breathing training and cognitive restructuring
~Virtual reality Exposure to agoraphobic situations and interoceptive exposure
~Relapse prevention"
16287658|NCT00734370|Behavioral|Standard exposure in vivo for agoraphobic participants|"This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of
~Psycho-education, breathing training and cognitive restructuring
~Standard exposure in vivo to agoraphobic situations and interoceptive exposure
~Relapse prevention (according to the protocol of Craske & Barlow)"
16287659|NCT00734357|Procedure|Blood work|Prior to having the clinically scheduled CT examination the subject will have blood work drawn. This blood work will give the investigators a baseline value of the basic kidney function of the subject. They will then have blood work done again at 2 days and again at 3 days following the CT examination. Some patients, based on their blood work obtained at 2 and 3 days after the CT examination, will be asked to have blood work performed at 7 days after their CT examination.
16287660|NCT00734344|Drug|Raltegravir|Raltegravir 400 mg. BID
16287661|NCT00734344|Drug|Efavirenz|600 mg once daily
16287662|NCT00734344|Drug|Emtricitibine|200mg once daily
16287663|NCT00734344|Drug|Tenofovir disoproxil once daily|300mg once daily
16287664|NCT00734344|Drug|Tenofovir disoproxil twice daily|300mg twice daily
16287665|NCT00734318|Drug|Flutiform 250/10 micrograms|
16287666|NCT00734318|Drug|Flutiform 50/5 micrograms|
16287667|NCT00734318|Drug|Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms|
16287668|NCT00734318|Drug|Flixotide pMDI 250 micrograms|
16287669|NCT00734305|Drug|MM-121|Dose escalation Frequency - once weekly
16287670|NCT00734292|Drug|fluticasone propionate, formoterol fumarate|"● Period 1 Treatment Regimen A: FlutiForm 250/10 ug
~FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
~● Period 2 Treatment Regimen B: FlutiForm 100/10 ug
~FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)
~● Period 3 Treatment Regimen C: placebo
~SKP placebo; (two actuations)"
16287671|NCT00734292|Other|fluticasone propionate, formoterol fumarate|"● Period 1 Treatment Regimen B: FlutiForm 100/10 ug
~FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)
~● Period 2 Treatment Regimen C: placebo
~SKP placebo; (two actuations)
~● Period 3 Treatment Regimen A: FlutiForm 250/10 ug
~FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)"
16287672|NCT00734292|Other|fluticasone propionate, formoterol fumarate|"● Period 1 Treatment Regimen C: placebo
~SKP placebo; (two actuations)
~● Period 2 Treatment Regimen A: FlutiForm 250/10 ug
~FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
~● Period 3 Treatment Regimen B: FlutiForm 100/10 ug
~FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)"
16287673|NCT00734279|Drug|Leuprolide Acetate - Early Puberty Leuprolide Visit|Dose of 10 mcg/kg Sub cutaneous once at 0800 on day 2 of the Early Puberty Luprolide Visit
16287674|NCT00734279|Drug|Ganirelix - Early Puberty Ganirelix Visit|Dose of 2.5 mcg/kg Sub-cutaneous once at 17:30 on day 1 of the Early Puberty Ganirelix Visit and once at 08:00 on day 2 of the Early Puberty Ganirelix Visit
16287675|NCT00734279|Drug|Ganirelix - Delayed Puberty Ganirelix Visit|Ganirelix is administered at a dose of 2.5 mcg/kg sub cutaneous at 17:30 on day 1 and once at 08:00 on day 2 of the Ganirelix Delayed Puberty Visit
16287676|NCT00734279|Drug|Leuprolide Acetate- Delayed Puberty Leuprolide Visit|Leuprolide acetate is given at a dose of10 mcg/kg at 0800 on day 2 of the Delayed Puberty Leuprolide Visit
16287677|NCT00734253|Drug|Pyridoxamine Dihydrochloride|150 mg capsules taken orally twice a day for 1-year.
16287678|NCT00734253|Drug|Pyridoxamine Dihydrochloride|300 mg capsules taken twice a day for 1-year.
16287679|NCT00734253|Drug|Placebo|Placebo capsules taken twice a day for 1-year
16287680|NCT00734240|Drug|ISIS 353512|50 mg via 2 hour IV infusion, single dose
16287681|NCT00734240|Drug|ISIS 353512|50 mg via 2 hour IV infusion, 6 doses over 22 days
16287682|NCT00734240|Drug|ISIS 353512|50 mg via SC injection, single dose
16287683|NCT00734240|Drug|ISIS 353512|50 mg via SC injection, 6 doses over 22 days
16287684|NCT00734240|Drug|ISIS 353512|2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
16287685|NCT00734240|Drug|ISIS 353512|100 mg via 2 hour IV infusion, single dose
16287686|NCT00734240|Drug|ISIS 353512|200 mg via 2 hour IV infusion, single dose
16287687|NCT00734240|Drug|ISIS 353512|100 mg via SC injection, single dose
16287688|NCT00734240|Drug|ISIS 353512|200 mg via SC injection, single-dose
16287689|NCT00734240|Drug|ISIS 353512|100 mg via 2 hour IV infusion, 6 doses over 22 days
16287690|NCT00734240|Drug|ISIS 353512|200 mg via 2 hour IV infusion, 6 doses over 22 days
16287691|NCT00734240|Drug|ISIS 353512|100 mg via SC injection, 6 doses over 22 days
16287692|NCT00734240|Drug|ISIS 353512|200 mg via SC injection, 6 doses over 22 days
16287693|NCT00734240|Drug|ISIS 353512|100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
16287694|NCT00734240|Drug|ISIS 353512|200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
16287695|NCT00734240|Drug|ISIS 353512|2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
16287696|NCT00734227|Procedure|Emergency portacaval shunt|
16287697|NCT00734227|Other|Emergency TIPS|
16287698|NCT00734214|Drug|0.9% NaCl|"Intravenous Fluid
~Isotonic Parenteral Fluid"
16287699|NCT00734214|Drug|0.45%NaCl|"Intravenous Fluid
~Hypotonic Parenteral Fluid"
16287700|NCT00734201|Drug|V24343|Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days
16287701|NCT00734188|Drug|PTI-6D2|monoclonal antibody
16287702|NCT00734175|Biological|H6N1 Teal HK 97/AA ca recombinant vaccine|Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
16287703|NCT00734162|Drug|Tenofovir disoproxil fumarate (TDF)|TDF administered as a 300-mg tablet once daily
16287704|NCT00734162|Drug|Placebo|TDF placebo tablet once daily
16287705|NCT00734149|Drug|Bortezomib|
16287706|NCT00734149|Drug|Melphalan|
16287707|NCT00734149|Drug|Prednisone|
16287708|NCT00734136|Procedure|Blood Draws and a hepatectomy specimen|"Pre operative blood draw(1.5 ml serum, 1.5 ml EDTA)(approximately 2 teaspoons).
~Blood draw during surgery(1.5 ml serum, 1.5 ml EDTA)from Hepatic Artery, Hepatic Vein, and Portal Vein.
~Wedge section of Hepatectomy specimen following resection in surgical subjects(tested for the same factors)"
16287709|NCT00734136|Procedure|Blood draw - pre operative standard of care|Pre-operative blood draw(1.5 ml serum, 1.5 ml EDTA)(approximately 2 teaspoons) from peripheral vein
16287710|NCT00734123|Drug|Simvastatin or Atorvastatin|Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
16287711|NCT00734123|Drug|Enalapril|Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
16287712|NCT00734123|Drug|Aspirin or clopidogrel|Aspirin 100 mg or clopidogrel 75 mg/ per day
16287713|NCT00734123|Drug|Rimonabant|"In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned.
~Drugs will be prescribed as the standard clinical care"
16287714|NCT00734110|Device|P.F.C. Sigma Total Knee System|An orthopaedic implant for total knee replacement
16287715|NCT00734097|Drug|Esomeprazole 40 mg|Once a day
16287716|NCT00734097|Procedure|Physical Exam|every visit
16287717|NCT00734097|Other|Quality of Life Questionnaires|every visit
16287718|NCT00734097|Procedure|pregnancy test, if applicable|as needed
16287719|NCT00734084|Device|Preservation Unicompartmental Knee|Minimally invasive orthopaedic implant for single compartment knee arthritis
16287720|NCT00734071|Drug|Vortioxetine|Encapsulated vortioxetine immediate-release tablets
16287721|NCT00734071|Drug|Placebo|Vortioxetine placebo-matching capsules
16287772|NCT00733668|Drug|Quetiapine fumarate (Seroquel)|300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks
16287722|NCT00734058|Device|Laser MAZE by Ablation of Cardiac Tissue|The protocol calls for the creation of the pulmonary vein isolation lesion through the use of the SOLAR™. The additional lesions are to be created using the ATRILAZE™. At surgeon discretion, the ganglia may be ablated and left and right atrial appendages may be removed.
16287723|NCT00734032|Drug|SB480848 40mg EC Tablet|1 tablet once a day
16287724|NCT00734032|Drug|SB480848 80mg EC Tablet|1 tablet once a day
16287725|NCT00734032|Drug|SB480848 160mg EC Tablet|1 tablet once a day
16287726|NCT00734032|Drug|SB480848 Placebo Tablet|1 tablet once a day
16287727|NCT00734019|Device|P.F.C. Sigma Knee|Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert
16287728|NCT00733993|Drug|Caffeine 150 MG|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
16287729|NCT00733993|Drug|Placebo|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
16287730|NCT00733993|Drug|Amphetamine|Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
16287731|NCT00733993|Drug|Caffeine 300 MG|Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
16287732|NCT00733980|Drug|GSK561679|GSK561679
16287733|NCT00733980|Other|Placebo|Placebo
16287734|NCT00733967|Drug|Varenicline|Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
16287735|NCT00733967|Drug|Placebo|Matching oral placebo capsules as control.
16287736|NCT00733954|Drug|clobetasol propionate spray|Apply twice daily
16287737|NCT00733954|Drug|clobetasol propionate ointment|Apply twice daily
16287738|NCT00733941|Behavioral|High frequency training|24 training sessions, 8x weekly, followed by detraining phase 8 weeks, and retraining
16287739|NCT00733941|Behavioral|normal frequence training|24 training sessions, 3x weekly, followed by detraining phase 8 weeks, and retraining
16287740|NCT00733928|Device|PFC Sigma knee with all-poly tibial component|Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
16287741|NCT00733928|Device|PFC Sigma knee with metal backed tibia|Orthopaedic implant for total knee replacement with a metal-backed tibial component
16287742|NCT00733915|Device|L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)|L.C.S. Complete mobile-bearing total knee system
16287743|NCT00733902|Biological|tanezumab|IV tanezumab 10 mg at 1 dose every 8 weeks
16287744|NCT00733902|Biological|tanezumab|IV tanezumab 5 mg at 1 dose every 8 weeks
16287745|NCT00733902|Biological|tanezumab|IV tanezumab 2.5 mg at 1 dose every 8 weeks
16287746|NCT00733902|Biological|Placebo|IV placebo to match tanezumab at 1 dose every 8 weeks
16287747|NCT00733889|Drug|cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)|"Neoadjuvant chemotherapy plus cetuximab:
~3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy.
~Radio-chemotherapy plus cetuximab:
~The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks).
~Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36"
16287748|NCT00733876|Biological|Multipotent Stromal Cells|Post-operative administration of MSC
16287749|NCT00733876|Biological|Administration of MSC|Dose escalation protocol
16287750|NCT00733863|Biological|Placebo|
16287751|NCT00733863|Biological|CAD106|
16287752|NCT00733850|Drug|Kanglaite Injection plus gemcitabine|Intravenous repeating dose
16287753|NCT00733850|Drug|Gemcitabine|Intravenous repeating dose
16287754|NCT00733837|Other|Nonspecific, Innocuous, Mechanoreceptor Stimulation|A custom device will be used to provide light manual cervical traction
16287755|NCT00733824|Drug|AMD3100|
16287756|NCT00733824|Drug|G-CSF|
16287757|NCT00733824|Procedure|Apheresis|
16287758|NCT00733811|Drug|Deferiprone (DFP) and Deferoxamine (DFO)|Sequential treatment including DFP at 75 mg/kg for four days per week and DFO by subcutaneous infusions (8-12h) at 50mg/kg/day for the remaining three days per week
16287759|NCT00733811|Drug|Deferiprone (DFP)|DFP alone at 75 mg/kg divided into three oral daily doses
16287760|NCT00733798|Drug|131I-TM601|After a single 20mCi/0.4 mg Imaging Dose of 131I-TM601, patients in the Dose Escalation Phase will be administered between 2-5 weekly doses of 131I-TM601 at 1.2 mCi/kg of lean body mass (specific activity of 131I-TM601 will be maintained at 50 mCi 131I/mg TM601 for all doses administered in this study.) Patients in the Efficacy Phase of the study will be treated at the Maximum Tolerated Dose established in the Dose Escalation Phase.
16287761|NCT00733785|Drug|Rosiglitazone XR|Rosiglitazone extended release formulation
16287762|NCT00733772|Dietary Supplement|flaxseed|30 grams/day of flaxseed for 12 weeks
16287763|NCT00733772|Behavioral|Health lifestyle counseling|Health lifestyle counseling accroding to AHA reccommendation
16287764|NCT00733746|Drug|erlotinib hydrochloride|oral administration
16287765|NCT00733746|Drug|gemcitabine hydrochloride|Intravenous administration
16287766|NCT00733746|Procedure|therapeutic conventional surgery|
16287767|NCT00733733|Drug|ATG Fresenius|One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)
16287768|NCT00733720|Drug|Suboxone|4/1mg, 8/2mg 16/4mg
16287769|NCT00733707|Behavioral|Text messaging reminders|Subjects in this arm will receive daily text message reminders once per day at the same time each day. Messages will remind the subject to take their oral contraceptive pill.
16287770|NCT00733694|Device|LCS® Complete™ Mobile Bearing Knee Systems|An orthopaedic implant for primary total knee replacement with a mobile bearing knee
16287771|NCT00733681|Device|PFC Sigma RP TC3 Revision knee system|Orthopaedic implant system for revision total knee replacement
16287773|NCT00733642|Biological|PF-04360365 1 mg/kg|PF-04360365 1 mg/kg infused as a single dose
16287774|NCT00733642|Biological|PF-04360365 3 mg/kg|PF-04360365 3 mg/kg infused as a single dose
16287775|NCT00733642|Biological|PF-04360365 5 mg/kg|PF-04360365 5 mg/kg infused as a single dose
16287776|NCT00733642|Biological|PF-04360365 10 mg/kg|PF-04360365 10 mg/kg infused as a single dose
16287777|NCT00733616|Drug|DOX: Docetaxel, oxaliplatin, Capecitabine|"Docetaxel 40 mg/m2, iv infusion 60 minutes, day 1
~Oxaliplatin 80 mg/m2, iv infusion 120 minutes, day 1
~Capecitabine 625 mg/m2, bid, oral, continuous
~6 cycles, every 3 weeks
~Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment)"
16287778|NCT00733603|Other|Global Therapeutic Massages (GTM)|Non-specific somatic treatment with full-body Western massage.
16287779|NCT00733603|Other|Myofascial Tissue Manipulation (MTM)|Targeted internal and external Connective Tissue Manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen.
16287780|NCT00733577|Drug|SB756050|doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
16287781|NCT00733564|Drug|Lidocaine|Paracervical injection of 2% Lidocaine to block associated nociception input
16287782|NCT00733564|Drug|Propofol|Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia
16287783|NCT00733564|Drug|Sevoflurane|Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
16287784|NCT00733551|Drug|GSK962040|GSK962040 tablets will be available in dosing strengths of 1 milligram, 5 milligrams, 25 milligrams given orally, once daily, in the morning, in a fasted state.
16287785|NCT00733551|Drug|Placebo|Placebo tablets will be given orally, once daily, in the morning, in a fasted state.
16287786|NCT00733538|Drug|zometa|patients receiving treatment during their follow-up
16287787|NCT00733525|Behavioral|Cognitive Behavioral Therapy|Therapy focusing on skills needed to alter eating patterns
16287788|NCT00733525|Drug|Fluoxetine|20 mg/day of fluoxetine, which can be incrementally increased to 80 mg/day
16287789|NCT00733525|Behavioral|Guided Self-Help|Manual designed to impart teachings of cognitive behavioral therapy
16287790|NCT00733512|Device|ReSTOR|Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.
16287791|NCT00733499|Device|LCS Complete Duofix|Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
16287792|NCT00733499|Device|LCS Complete Porocoat|Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
16287793|NCT00733486|Device|L.C.S. APG Knee Anterior Posterior Glide knee|Orthopaedic implant for primary knee replacement
16287794|NCT00733473|Drug|Budesonide 0.5 mg/ml nebules|Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
16287795|NCT00733473|Drug|% 0.9 Saline solution|Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
16287796|NCT00733460|Drug|BFPET|
16287797|NCT00733447|Device|CardioWest temporary Total Artificial Heart (TAH-t) System|The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.
16287798|NCT00733434|Drug|Prostaglandin E1|PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
16287799|NCT00733434|Other|Saline|500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
16287800|NCT00733421|Drug|etoricoxib|90 mg once daily
16287801|NCT00733421|Drug|tramadol|100 mg twice daily
16287802|NCT00733408|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16287803|NCT00733408|Biological|bevacizumab|Given IV
16287804|NCT00733408|Drug|erlotinib hydrochloride|Given PO
16287805|NCT00733395|Dietary Supplement|Tart Cherry Juice|Participants will ingest 10.5 fl oz of cherry juice twice a day for 7 days prior to the race, and the day of the race (8 days total).
16287806|NCT00733395|Dietary Supplement|Fruit juice|Participants will ingest 10.5 fl oz of fruit juice twice a day for 7 days prior to the race, and the day of the race (8 days total), which will serve as a 'placebo' juice.
16287807|NCT00733382|Drug|dexamethazone|injection form, 8 miligram, injected once
16287808|NCT00733369|Device|PFC Sigma RP-F|An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
16287809|NCT00733369|Device|PFC Sigma RP|An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
16287810|NCT00733356|Drug|Vyvanse|Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast.
16287811|NCT00733343|Device|Europe: AutoSet CS (USA: VPAP Adapt SV)|At least 3 hours average daily usage time
16287812|NCT00733330|Device|Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique|Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
16287813|NCT00733330|Device|Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation|Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation
16287814|NCT00733317|Drug|0.5 mg/ml budesonide nebules|Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
16287815|NCT00733317|Drug|Saline|Children will receive 2 ml of saline every 20 minutes for 3 times
16287816|NCT00733304|Drug|Pazopanib|5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
16287817|NCT00733291|Device|Nelfilcon A contact lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
16287818|NCT00733291|Device|Etafilcon A contact lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
16287819|NCT00733291|Device|FID 107027 solution|Commercially marketed solution for contact lens disinfection
16287820|NCT00733278|Device|Copper IUD ( ParaGard Intrauterine Contraceptive Device)|Intraoperative placement of copper IUD at time of C-section
16287821|NCT00733265|Drug|AZD6140|single oral dose
16287822|NCT00733252|Procedure|bronchoscopic and lung imaging studies|Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
16287823|NCT00733252|Procedure|diagnostic bronchoscopy|Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
16287824|NCT00733252|Procedure|histopathologic examination|All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
16287825|NCT00733252|Procedure|optical coherence tomography|Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
16287826|NCT00733239|Drug|2-4 of the drugs listed below|Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given
16287827|NCT00733226|Drug|OM-85 BV (Broncho-Vaxom)|3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
16287828|NCT00733226|Drug|OM-85 BV (placebo)|3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months
16287829|NCT00733200|Procedure|Minor or Major Liver Resection|
16287830|NCT00733187|Drug|ABT-869|0.25 mg/kg
16287831|NCT00733174|Drug|Rosiglitazone|tablet
16287832|NCT00733174|Drug|Placebo|
16287833|NCT00733161|Other|Passive leg cycle exercise with stretching and resistance training|Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training
16287834|NCT00733161|Other|Stretching and resistance training|Stretching and resistance training everyday but no Passive leg cycle exercise
16287835|NCT00733148|Drug|dosing of insulin|Dosing od insulin is calculated by a computer based algorithm
16287836|NCT00733135|Device|SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device|Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.
16287837|NCT00733122|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 mL of GARDASIL as intramuscular injections at the Day 1, Month 2, and Month 6 visits.
16287838|NCT00733109|Procedure|Excision of the lesion|Surgery with Large Loop Excision of Transformation Zone (LLETZ)
16287839|NCT00733109|Other|Follow-up for spontaneous regression of the lesion|Follow-up at last 12 months
16287840|NCT00733096|Drug|etanercept|Two transforaminal epidural injections of 4 mg, two weeks apart
16287841|NCT00733096|Drug|methylprednisolone|Two transforaminal epidural steroid injections with 60 mg, two weeks apart
16287842|NCT00733096|Drug|normal saline|Two transforaminal epidural saline injections, two weeks apart
16287843|NCT00733083|Drug|0,1 mg/kg of oxycodone|solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
16287844|NCT00733083|Drug|Morphine 0,1 mg/kg|solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
16287845|NCT00733083|Drug|Dexamethasone 0,5 mg/kg|solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia
16287846|NCT00733083|Drug|NaCl 0,9%|solution for injection one injection in the beginning of anesthesia
16287847|NCT00733070|Device|CiTop™ ExPander™ Guidewire|Chronic Total Occlusion guidewire
16287848|NCT00733057|Drug|Minocycline|Minocycline as an add-on drug (200 mg/day)
16287849|NCT00733057|Drug|Placebo (200 mg/day)|
16287850|NCT00733044|Behavioral|Specialized Care|The intervention consists of the integration of integral tinnitus management provided by a specialized tinnitus centre in the health care system. The tinnitus centre offers care following a stepped-care approach with two levels. The first level of intervention consists of audiological diagnostics and intervention, a tinnitus educational group session and a individual consult with a clinical psychologist. For patients with mild complaints this basic intervention is expected to suffice. For patients with moderate to severe complaints a second level of intervention exists. This level of intervention consists of combinations of the following therapies: Cognitive Behavioural Therapy (CBT), Attention Diversion (AD), exposure techniques, and Relaxation Therapy (RT).
16287851|NCT00733044|Other|Usual Care|Usual care consists of a standardized version of treatment that is currently applied in peripheral audiological centres throughout the Netherlands. A telephone survey was conducted amongst all audiological centres (n=28) in the Netherlands. The results of this survey determined the content of the usual care treatment protocol in the current study. The treatment consists of audiological diagnostics and intervention and, if necessary, one or more consults with a social worker with a maximum of ten one hour sessions.
16287852|NCT00733031|Drug|AZD6918|liquid suspension, daily, oral dose
16287853|NCT00733031|Drug|gemcitabine|intravenous, doses are on an intermittent schedule
16287854|NCT00733031|Drug|pemetrexed|intravenous, dose administered every 21-days
16287855|NCT00733018|Behavioral|"Western versus balanced macro nutrient diet composition"|Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.
16287856|NCT00733005|Drug|Mometasone furoate nasal spray (MFNS)|MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
16287857|NCT00733005|Drug|Matching placebo nasal spray|Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
16287858|NCT00732992|Drug|Sunitinib, Pemetrexed|Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.
16287859|NCT00732992|Drug|Sunitinib, Pemetrexed|Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.
16287860|NCT00732979|Procedure|Infrahepatic inferior vena cava clamping|The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards.
16287861|NCT00732979|Procedure|No infrahepatic inferior vena cava clamping|Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below < 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration.
16287862|NCT00732966|Drug|losartan|with losartan 50 mg once daily for one month
16287863|NCT00732966|Drug|valsartan|valsartan 160 mg once daily
16287864|NCT00732953|Device|Genous stent implantation with paclitaxel-eluting balloon dilation|Genous stent implantation with paclitaxel-eluting balloon therapy
16287865|NCT00732953|Device|Genous stent implantation|Genous stent implantation
16287866|NCT00732940|Drug|Belimumab 100 mg SC|Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
16287867|NCT00732940|Drug|Belimumab 100 mg SC|Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
16287868|NCT00732927|Drug|parnaparin|vials, 6.400 IU sc twice daily for 7 days, then once daily for a total of 3 months
16287869|NCT00732927|Drug|aspirin|tablets, 100 mg for 3 months
16287870|NCT00732914|Drug|Sunitinib (Sutent)|Sunitinib 50 mg once daily 4 weeks on, 2 weeks off, and after discontinuation (due to PD or toxicity), followed by sorafenib 400 mg BID
16287871|NCT00732914|Drug|Sorafenib (Nexavar)|Sorafenib 400 mg BID, followed by Sunitinib 50 mg once daily 4 weeks on, 2 weeks off, and after discontinuation (due to PD or toxicity)
16287872|NCT00732901|Drug|Escitalopram|Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
16287873|NCT00732901|Drug|Placebo|Once daily days 1-28
16287874|NCT00732888|Drug|Nilotinib Hydrochloride|Dosage form: capsules Dosage: 400 mg (2 x 200 mg capsule) Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
16287875|NCT00732888|Dietary Supplement|calcium carbonate|Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)
16287876|NCT00732875|Biological|Infliximab + methotrexate (MTX)|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
16287877|NCT00732862|Procedure|glucose clamp|Hyperinsulinemic Hypoglycemic clamp
16287878|NCT00732862|Procedure|glucose clamp|Hyperinsulinemic Hypoglycemic clamp
16287879|NCT00732849|Drug|Reconvan, Dipeptiven, Omegaven|Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.
16287880|NCT00732836|Drug|HAI Abraxane|Escalating doses (beginning dose 180 mg/m^2) starting Day 1, Cycle 2 and later via hepatic arterial infusion (HAI) following IV Abraxane in Day 1, Cycle 1 for 21 day cycles.
16287881|NCT00732836|Procedure|Hepatic Artery Catheter|On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology.
16287882|NCT00732836|Drug|IV Abraxane|Intravenous (IV) Abraxane only in Cycle 1 (up to Dose Level 4 of 260 mg/m^2), infused over 60 minutes or 4 hours Day 1 of 21 day cycle.
16287883|NCT00732823|Device|Placebo - No device worn|
16287884|NCT00732823|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287885|NCT00732823|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287886|NCT00732823|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287887|NCT00732810|Drug|SCH 727965|SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression.
16287888|NCT00732810|Drug|Capecitabine|Capecitabine 1250 mg/m^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression.
16287889|NCT00732810|Drug|Erlotinib|Erlotinib 150 mg orally once daily until disease progression.
16287890|NCT00732797|Behavioral|Self-treatment booklet|A booklet outlining vestibular rehabilitation exercises
16287891|NCT00732797|Behavioral|Remote telephone support|Up to an hour's remote support from an expert vestibular therapist
16287892|NCT00732784|Drug|Imatinib mesylate|Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
16287893|NCT00732784|Dietary Supplement|calcium carbonate|Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)
16287894|NCT00732771|Drug|LCI699|
16287895|NCT00732758|Dietary Supplement|Vitamin D3 1000 IU|Vitamin D3 1000 IU Tablet once daily for 6 months
16287896|NCT00732758|Dietary Supplement|Placebo Tablet|Placebo Tablet once daily for 6 months
16287897|NCT00732745|Drug|docetaxel|Given IV
16287898|NCT00732745|Drug|oxaliplatin|Given IV
16287899|NCT00732745|Drug|vandetanib|Given orally
16287900|NCT00732745|Other|placebo|Given orally
16287901|NCT00732732|Dietary Supplement|Green banana powder|Green banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age.
16287902|NCT00732732|Other|Microcrystalline cellulose|Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more
16287903|NCT00732719|Device|Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs|
16287904|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287905|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287906|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287907|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287908|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287909|NCT00732719|Device|Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs|
16287910|NCT00732706|Procedure|Sartorius Muscle Twitch|Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.
16287911|NCT00732706|Procedure|Quadriceps Muscle Twitch|Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.
16287912|NCT00732693|Drug|Ethinylestradiol / Norethisterone|"Oral ethinylestradiol 30mcg and norethisterone 1.5mg daily for weeks 1-3, followed by 7 pill free days"
16287913|NCT00732693|Drug|Estradiol / Progesterone|Transdermal estradiol 100mcg daily for week 1, then 150mcg daily for weeks 2-4; and vaginal progesterone pessaries 200mg twice daily for weeks 3-4
16287914|NCT00732680|Drug|Botulinum Toxin Type A|10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
16287915|NCT00732654|Drug|Milk Protein Extract Immunotherapy goal of 4mg/day|Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
16287916|NCT00732654|Drug|Milk Protein Extract Immunotherapy goal of 7mg/day|Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
16287917|NCT00732654|Drug|Milk Powder Immunotherapy goal dose 2000 mg/day|Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
16287918|NCT00732654|Drug|Milk Powder Immunotherapy goal dose 1000mg/day|Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
16287919|NCT00732641|Drug|Peginterferon|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
16287920|NCT00732628|Device|Boomerang closure device|Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.
16287921|NCT00732615|Drug|Placebo|Placebo for subcutaneous injection
16287922|NCT00732615|Drug|NPSP558|Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily
16287923|NCT00732602|Other|GIP-infusion|
16287924|NCT00732602|Other|Sodium-chloride|
16287925|NCT00732602|Other|GLP-2 infusion|
16287926|NCT00732589|Drug|1% xylocaine|10 cc. of 1%xylocaine, once a week
16287927|NCT00732589|Other|ultrasound|ultrasound at shoulder area about 10 mins.
16287928|NCT00732576|Dietary Supplement|menaquinone-7|capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
16287929|NCT00732576|Dietary Supplement|fish oil|9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
16287930|NCT00732576|Dietary Supplement|krill oil|9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks
16287931|NCT00732563|Drug|chemotherapy|Given IV and Orally
16287932|NCT00732563|Procedure|lymphadenectomy|Removal of lymph nodes
16287933|NCT00732563|Procedure|neoadjuvant therapy|Tumor reduction
16287934|NCT00732563|Procedure|quality-of-life assessment|Correlative Study
16287935|NCT00732563|Procedure|therapeutic conventional surgery|Treatment for cancer
16287936|NCT00732563|Procedure|thoracic surgical procedure|removal of tissue
16287937|NCT00732563|Radiation|fludeoxyglucose F 18|given IV
16287938|NCT00732563|Radiation|radiation therapy|undergoing radiotherapy
16287939|NCT00732550|Procedure|Single trocar cholecystectomy|Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
16287940|NCT00732550|Procedure|Standard laparoscopic cholecystectomy|Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
16287941|NCT00732537|Drug|inhaled Nitric Oxide|"iNO started at 20 ppm for 1 hour, then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). If >5% drop in oxygen saturation was observed during weaning, study gas was increased to the previous concentration and weaning done 2 hourly. If > 5% drop in oxygen saturation or >5% Methemoglobin was observed during initial administration, the study gas would be weaned over 30 minutes and the infant would exit. The iNO was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. Monitoring of O2, NO2, NO was done by placing the end of the sample line inside the oxyhood. A Masking Shield covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment."
16287942|NCT00732537|Drug|Oxygen (>90% by hood) - standard therapy|"Oxygen (>90% by hood, standard therapy for PPHN prior to intubation) was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. If the baby was randomized to the control group and did not receive NO, the INOmax® cylinder was opened and used only to pressurize the system, which prevented the Low NO Pressure alarm. A Masking Shield covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment."
16287943|NCT00732524|Drug|Glipizide|Glipizide XL 10 mg once daily 30 mins before breakfast
16287944|NCT00732524|Drug|Glipizide and Glargine|Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily
16287945|NCT00732511|Drug|carvedilol|capsules in doses of 20, 40, and 80 mg; once daily; 12 weeks duration
16287946|NCT00732511|Drug|metoprolol extended release|tablets in doses 50, 100, and 200 mg; once daily; 12 weeks duration
16287947|NCT00732498|Drug|Methylprednisolone|250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
16287948|NCT00732498|Drug|Etoposide|40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
16287949|NCT00732498|Drug|Cytarabine|2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
16287950|NCT00732498|Drug|Cisplatin|25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow <25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
16287951|NCT00732498|Drug|Rituximab|250 mg/m2 slow IV over days 1, then 7,8 or 9 prior to In Zevalin. Rituximab + Zevalin regimen is given 4-6 weeks after completion of 2 cycles of ESHAP. Treatment can be completed within 7-9 days in an outpatient setting.
16287952|NCT00732498|Drug|In-Zevalin|5 mCi slow IV push over 10 minutes days 1. Given within 4 hours after Rituximab.
16288069|NCT00731614|Behavioral|Supportive therapy|Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
16287953|NCT00732498|Drug|Y-Zevalin|Platelet counts from 100,000/mm3 to 149,000/mm3 will receive 0.3 mCi/kg. Platelet counts from >/= 150,000/mm3 will receive 0.4 mCi/kg, not to exceed 32 mCi Y Zevalin. Slow IV push over 10 minutes, days 7,8 or 9 given within 4 hours after Rituximab.
16287954|NCT00732485|Drug|fenofibrate|Fenofibrate, PO, 5 mg/kg/day from admission to 6 months post burn
16287955|NCT00732485|Drug|placebo|Placebo, sugar pill, from admission to 6 months post burn
16287956|NCT00732472|Drug|GSK573719|7 day repeat dose
16287957|NCT00732459|Device|Electro-acupuncture preconditioning|electro-acupuncture
16287958|NCT00732446|Drug|Moxifloxacin and Dexamethasone combined|moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
16287959|NCT00732446|Drug|Moxifloxacin|moxifloxacin 0,5% qid and
16287960|NCT00732446|Drug|Dexamethasone|dexamethasone 0,1% qid
16287961|NCT00732433|Procedure|digital mammography|Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.
16287962|NCT00732420|Drug|topotecan|Topoisomerase I inhibition.
16287963|NCT00732420|Drug|pazopanib|Tyrosine kinase inhibitor
16287964|NCT00732407|Drug|aliskiren|Aliskiren will be given in a preliminary dosage of 150 mg per day, after a follow up of two weeks dosage will be increased to 300 mg per day.
16287965|NCT00732407|Drug|losartan|Losartan will be given in a preliminary dosage of 50 mg per day and after a two weeks follow up dosage will be increased to 100 mg per day
16287966|NCT00732394|Other|MSDR|"The MSDR® questionnaire establishes an individual's musculoskeletal functional status using information gathered from 1) a questionnaire the patient fills out regarding medical history, chronic medical conditions, and health risk factors; 2) anatomic pain survey completed by the patient; and 3) evaluation by a trained researcher of various patient biometric parameters related to range of motion. Stratifying an individual into a risk category with this evidence-based assessment tool then permits an assessment of which patients respond long term to therapy.
~MSDR® demonstrates the ability to benchmark specific musculoskeletal findings (both clinical and sub-clinical) to ICD-9 Diagnoses supported by diagnostic, radiographic and/or MRI findings where clinically indicated."
16287967|NCT00732381|Drug|Mometasone furoate nasal spray (MFNS)|MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
16287968|NCT00732381|Drug|Matching placebo nasal spray|Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
16287969|NCT00732368|Drug|Mometasone furoate|Two sprays mometasone nasal spray per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily.
16287970|NCT00732355|Device|Syph-Check POC|Rapid membrane test for syphilis antibodies
16287971|NCT00732342|Behavioral|Contingency Management|Prizes given for targeted behavior of abstinence
16287972|NCT00732329|Behavioral|Occupational Therapy|"optimized home Based Occupational Therapy including:
~diagnostic assessment
~patient-centered definition of targets involving the care giver
~occupational therapy"
16287973|NCT00732316|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|administration of conditioning therapy including immunosuppressive agents plus alkylating agents and infusing hematopoietic progenitor cells collected from the donor
16287974|NCT00732316|Procedure|peripheral blood stem cell transplantation|infusion of donor hematopoietic cells collected by leukapheresis after mobilization with growth factor
16287975|NCT00732303|Drug|Pemetrexed|Pemetrexed (Alimta) 500mg/^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
16287976|NCT00732303|Radiation|Radiation Therapy|"Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
16287977|NCT00732290|Drug|Clopidogrel then fluoxetine+clopidogrel|D1 : clopidogrel (Plavix) 600mg (8 tablets) one time D45 to D48 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D49 : 20mg Fluoxetine + 600mg Clopidogrel
16287978|NCT00732290|Drug|Fluoxetine+clopidogrel then clopidogrel|D1 to D4 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D5: 20mg Fluoxetine + Clopidogrel (Plavix) 600mg (8 tablets) one time D49 : Clopidogrel 600mg one time
16287979|NCT00732277|Drug|hydrocortisone|Patients will be assigned to treatment with hydrocortisone at 100mg/m2/24 hours in 4 divided doses (25 mg/m2/q 6 hourly) for 8 doses (48 hours) in phase 1 of study (45 patients, 30 receive IMP) or 20 doses (120 hours) in phase 2 (45 patients, 30 receive IMP).
16287980|NCT00732251|Drug|Allopurinol|Allopurinol: 300-600 mg/day over a 24 month period
16287981|NCT00732238|Other|Shortened course of antibiotic therapy|By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
16287982|NCT00732238|Other|Standard Therapy|Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
16287983|NCT00732225|Device|DisCoVisc|DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
16287984|NCT00732225|Device|DuoVisc|DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
16287985|NCT00732225|Device|BioVisc|BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
16287986|NCT00732225|Device|Healon5|Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
16287987|NCT00732225|Device|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
16287988|NCT00732212|Device|Doppler endoscopic ultrasound probe for blood flow detection|Used for blood flow detection
16288101|NCT00731315|Other|Usual care group|This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.
16287989|NCT00732212|Other|Standard endoscopic hemostasis|Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment.
16287990|NCT00732199|Other|1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia|1) noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation
16287991|NCT00732186|Biological|Ipilimumab|IV Solution, IV, 10 mg/kg, (if dose reduction necessary at 3 mg/kg), Every three weeks for the first 10 weeks, with a booster at week 22, Up to 38 weeks depending on response
16287992|NCT00732173|Behavioral|behavioral dietary intervention|Undergo SUCCEED lifestyle intervention
16287993|NCT00732173|Behavioral|exercise intervention|Undergo SUCCEED lifestyle intervention
16287994|NCT00732173|Other|counseling intervention|Undergo SUCCEED lifestyle intervention
16287995|NCT00732173|Other|educational intervention|Receive information
16287996|NCT00732173|Other|survey administration|Undergo SUCCEED lifestyle intervention
16287997|NCT00732160|Drug|Aldosterone infusion (A)|Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
16287998|NCT00732160|Drug|Vehicle Infusion (V)|Vehicle infusion for 12.5 hours
16287999|NCT00732160|Other|High Sodium Diet (HS)|160 mmol/d sodium diet for 7 days
16288000|NCT00732160|Other|Low Sodium Diet (LS)|20 mmol/d sodium diet for 9 days
16288001|NCT00732147|Drug|Pramlintide acetate|120 micrograms given subcutaneously before each meal X 3.
16288002|NCT00732147|Drug|Placebo|120 micrograms given subcutaneously before each meal x 3.
16288003|NCT00732121|Drug|Sitagliptin|100 mg daily for 4 weeks
16288004|NCT00732121|Drug|Placebo|Placebo
16288005|NCT00732108|Drug|topiramate|50mg orally for 2 weeks, then 100mg orally for 6 weeks
16288006|NCT00732108|Drug|lactulose placebo pill|1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
16288007|NCT00732095|Behavioral|Promoting Self-Change with Ads|Use of Ads immediate or delayed or no ad
16288008|NCT00732082|Drug|Gemcitabine|
16288009|NCT00732082|Biological|LAG-3|
16288010|NCT00732069|Drug|Placebo|Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
16288011|NCT00732069|Drug|Ramipril|Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
16288012|NCT00732069|Drug|Valsartan|Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
16288013|NCT00732056|Drug|GRN163L|25% dose escalation infused over 2 hours weekly
16288014|NCT00732043|Dietary Supplement|pomegranate extract|8 oz per day, 48 months
16288015|NCT00732043|Dietary Supplement|pomegranate juice|8 oz per day, 48 months
16288016|NCT00732043|Dietary Supplement|placebo|8 oz per day, 48 months
16288017|NCT00732030|Device|Toric IOL (SN60T3)|Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
16288018|NCT00732017|Device|Standard physical therapy and HVPC with positive polarity|A high voltage stimulator with positive polarity was used with a direct pulsed monophasic current, double peak, 5 and 8micros duration and separated by a pulsate interval of 75micros and monopolar application with a dispersive electrode in the lumbar region and two transarticular active electrodes. The intensity of the current was under motor level, that is, just before a visible motor response could be observed. The frequency used was 120pps, in a continuous mode and was applied once a day with thirty-minute duration.
16288019|NCT00732017|Device|high voltage pulse stimulation with negative polarity|A high voltage stimulator with negative polarity was used with a direct pulsed monophasic current, double peak, 5 and 8micros duration and separated by a pulsate interval of 75micros and monopolar application with a dispersive electrode in the lumbar region and two transarticular active electrodes. The intensity of the current was under motor level, that is, just before a visible motor response could be observed. The frequency used was 120pps, in a continuous mode and was applied once a day with thirty-minute duration.
16288020|NCT00732017|Other|standard physical therapy treatment|"Initial phase: Application of crushed ice on the ankle for 20 minutes. The subject performed isometric and active exercises of the ankle in all freedom degrees, with no weight bearing.
~Intermediate phase: Application of cryotherapy continued and once mobility was completed and painless, progressive use of weight and reeducation of the walking pattern were initiated. Then, exercises with manual resistance of muscles of ankle and balance in stable surfaces were done.
~Advanced phase: Balance exercises on unstable surfaces as well as strengthening ankle muscles with proprioceptive neuromuscular facilitation techniques and elastic band were performed. At the end, the patient did activities like trotting in S or Z and jumping in all directions."
16288021|NCT00732004|Device|Silicone Hydrogel Contact Lenses|
16288022|NCT00732004|Device|1x PMBH preserved MPS|
16288023|NCT00732004|Device|1x Polyquad/Aldox MPS|
16288024|NCT00731991|Other|ART|ART to the levator scapulae.
16288025|NCT00731991|Other|PNF|PNF to the levator scapulae.
16288026|NCT00731991|Other|No Treatment|No treatment will be given. The participant will sit in the treatment room with the doctor for 4 minutes.
16288027|NCT00731978|Procedure|Restricted intraoperative fluid management|Intraoperative fluid management guided by Sto2.
16288408|NCT00729183|Drug|Odanacatib|Odanacatib 50 mg tablets, taken orally once weekly for 24 months.
16288028|NCT00731965|Biological|Measles, Mumps, Rubella vaccination|Dosage: 1 dose MMR vaccine, containing 5000 p.f.u. (plaque forming unit) life attenuated mumps virus (Jeryl-Lynn-strain), 1000 p.f.u. life attenuated measles virus (Moraten-strain) and 1000 p.f.u. life attenuated rubella virus (Wistar RA 27/3-strain) + 0.5 ml solution fluid Dosage form: subcutaneously frequency: once
16288029|NCT00731952|Drug|Velcade and Vorinostat|Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.
16288030|NCT00731939|Device|Inflatable Penile Prosthesis|Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
16288031|NCT00731926|Dietary Supplement|Oligomerized litchi fruit extract|100mg at once twice a day for 1 month
16288032|NCT00731926|Dietary Supplement|VItamin C + Vitamin E mixture|Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month
16288033|NCT00731926|Other|placebo|twice a day for 1 month
16288034|NCT00731913|Other|Absorable, monofilament sutures: Monosyn and Monocryl|Subjects were randomized to Monosyn vs. Monocryl suture arms. The designated skin lesion was removed surgically. The surgical repair of the defect was performed by dividing the wound in half by a single Prolene suture. The appropriate suture was opened by the Study Coordinator and passed sterilely to the surgical technician. The surgical technician loaded the suture, and passed it in a blinded fashion to the physician who closed the appropriate half of the surgical defect. One half of the wound was closed with one suture and the other half was closed with the other suture. Each patient served as their own control, as both sutures were used in each study patient.
16288035|NCT00731887|Procedure|Blood and urine testing|complete blood count, routine chemistries, liver function test, retinol binding protein, transferrin, prothrombin time, partial thromboplastin time, fibrinogen, Vitamin A and Zinc, Insulin Growth Factor levels and binding proteins, cytokines (interleukins 1, 6, 12), insulin, thyroid hormones, cortisol, 25-hydroxyvitamin D, and osteocalcin.
16288036|NCT00731874|Drug|Tacrolimus|Dosed to achieve target trough concentrations.
16288037|NCT00731861|Drug|Paclitaxel plus PTK787|"Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT.
~In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY."
16288038|NCT00731848|Dietary Supplement|pomegranate liquid extract|Pomegranate liquid extract, 8 oz per day, for 52 weeks
16288039|NCT00731835|Procedure|Endovascular Revascularization|"angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
~stent placement
~atherectomy"
16288040|NCT00731822|Drug|GW685698/GW642444|GW685698/GW642444
16288041|NCT00731809|Radiation|FDG PET CT|FDG PET CT
16288042|NCT00731796|Device|Functional Outcome Measure|Functional Outcome Measure is a computerized test performed by the subject. The subject sits at a computer and answers questions about their visual deficit and its impact. The patient then performs a Vision Preference Scale test intended to rate the overall quality of life. A reading test is performed that measures reading speed, accuracy, and comprehension. Finally a Visuospatial Attention test is given to measure object localization, object recognition,and motion recognition.
16288043|NCT00731783|Drug|2% Mupirocin Ointment|Apply ointment to the anterior nares twice daily for 5 days.
16288044|NCT00731783|Drug|4% Chlorhexidine liquid soap|Bathe with liquid soap daily for 5 days.
16288045|NCT00731783|Behavioral|Hygiene protocol|"Follow key hygiene tips indefinitely. Tips are:
~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
~Use liquid(pour or pump) soaps instead of bar soaps.
~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
~Do not share personal care items such as razors and brushes.
~Wash all sheets and towels in hot water. Wash sheets every week.
~Use towels and wash cloths only once before washing and do not share."
16288046|NCT00731770|Drug|Advair 250|1 puff bid inhaled
16288047|NCT00731770|Drug|Placebo- matched|1 puff bid inhaled
16288048|NCT00731770|Drug|Placebo|Placebo 1 puff bid inhaled
16288049|NCT00731770|Drug|Advair 250 - matched|i puff bid inhaled
16288050|NCT00731757|Drug|Humira|80 mg at week 0, then 40 mg weekly from week 1-week 23.
16288051|NCT00731744|Procedure|Normal full-term deliveries|Normal full-term deliveries by standard procedures according to institutional guidelines
16288052|NCT00731731|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo radiotherapy
16288053|NCT00731731|Procedure|Cognitive Assessment|Ancillary studies
16288054|NCT00731731|Other|Laboratory Biomarker Analysis|Correlative studies
16288055|NCT00731731|Drug|Temozolomide|Given PO
16288056|NCT00731731|Drug|Vorinostat|Given PO
16288057|NCT00731718|Device|lousebuster|Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment
16288058|NCT00731705|Procedure|collection of peripheral blood and apheresis samples|Sixty mL of peripheral blood will be collected from consenting eligible donors. Additionally, after the laboratory techniques have been fully evaluated, leukopheresis samples will also be collected.
16288059|NCT00731692|Drug|FTY720|Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily
16288060|NCT00731692|Drug|Placebo|Matching placebo capsules were administered orally once daily
16288061|NCT00731679|Drug|Rifaximin|
16288062|NCT00731679|Drug|Placebo|
16288063|NCT00731666|Device|Inflatable Penile Prosthesis|Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.
16288064|NCT00731653|Drug|Combination Product: BCI-024 + BCI-049|BCI-024 and BCI-049 once a day at bedtime for 6 weeks
16288065|NCT00731640|Device|ReSTOR|AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
16288066|NCT00731627|Drug|placebo|one tablet a day for up to 21 days
16288067|NCT00731627|Drug|simvastatin|simvastatin 40mg once a day for a maximum of 21 days
16288068|NCT00731614|Behavioral|Cognitive Behavioral Therapy and Mirror Retraining|Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
16288070|NCT00731614|Behavioral|Mirror retraining|Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain
16288071|NCT00731601|Drug|pantoprazole|pantoprazole 40 mg/q6h IV infusion for three days
16288072|NCT00731601|Drug|pantoprazole|pantoprazole 8 mg/h IV infusion for three days
16288073|NCT00731588|Biological|Transfused Biotin RBCs - Adults Phase I|A 3 mL venous blood sample is obtained. 250 mL of blood will be drawn to a blood collection bag containing the anticoagulant CPD. Separate equal volumes of RBCs are labeled with up to five different densities of biotin. The biotinylated RBCs are resuspended in autologous plasma to achieve a 60 to 70% hematocrit. An IV is inserted for the reinfusion of the biotinylated RBCs. Three mL aliquots of blood are sampled at 5, 10, 20, and 60 minutes after infusion. The subject returns ~24 hours and 3 days after the RBC infusion to obtain a 3 mL venous blood sample. Subjects return for weekly 3 mL blood sampling.
16288074|NCT00731588|Biological|Transfused Biotin RBCs - Infants Phase II|After the infant's clinical care team decides that a RBC transfusion is needed, a 15mL/kilogram of body weight is ordered. Transfusion will be given in 2 parts: 1) approximately 80% of the total transfusion to be transfused over 3-4 hours and 2) approximately 20% of the total transfusion will be marked with biotin to be transfused upon completion of the first part. The bedside nurse maintains constant observation of the infant as appropriate for the infant's condition, assessing for signs and symptoms of a transfusion reaction.
16288075|NCT00731588|Biological|Transfused Biotin RBCs - Infants Phase III|Phase III (infants) to be determined upon completion of Phase II (infants).
16288076|NCT00731575|Drug|prednisolone|First dose 2 mg/kg (max 60 mg) p.o., then 2 mg/kg/d (max 60 mg/d) p.o. in 3 divided doses for 3 days.
16288077|NCT00731562|Drug|Varenicline Tartrate Controlled Release|A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
16288078|NCT00731562|Drug|Varenicline Tartrate Controlled Release|A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
16288079|NCT00731549|Drug|Aripiprazole IM Depot|300mg or 400mg
16288080|NCT00731536|Other|No intervention|This is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.
16288081|NCT00731523|Drug|fingolimod (FTY720)|
16288082|NCT00731510|Dietary Supplement|Carbohydrate energy drink|Complex carbohydrates including maltodextrin (97%) dissolved in water to make a a 10% solution, or dissolved in 25mL gels. Ad libitum. Twenty two days.
16288083|NCT00731510|Dietary Supplement|Aspartame|Aspartame dissolved in water, ad libitum, 22 days.
16288084|NCT00731497|Device|Solar Water Disinfection (SODIS)|Intervention group has SODIS implemented at the household level as a way to disinfect drinking water
16288085|NCT00731471|Biological|MVA85A|Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.
16288086|NCT00731458|Device|Optical coherance tomography ( Cirrus; Stratus)|Non-contact retinal thickness analyzer
16288087|NCT00731445|Drug|Z-208|Oral pills taken daily; 8mg, 12mg, 16mg, 4mg
16288088|NCT00731432|Drug|Transmucosal Herbal Periodontal Patch (THPP)|Patch applied to oral gingiva
16288089|NCT00731432|Drug|Placebo Patch|Identical in shape and texture to treatment patch
16288090|NCT00731419|Device|SEMS|Comparing plastic and metal stents
16288091|NCT00731393|Biological|Thiomersal free trivalent influenza split vaccine 2003/2004|2 doses, intramuscular injection
16288092|NCT00731393|Biological|GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004|2 doses, intramuscular injection
16288093|NCT00731380|Drug|ABI-007|Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-Fluorouracil (5-FU) 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.
16288094|NCT00731367|Device|Aquacel Ag Gelled|AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
16288095|NCT00731367|Device|Aquacel Ag Adherent|AQUACEL Ag is produced by changing a small fraction of the sodium ions present in AQUACEL for silver ions and then stabilizing the complex formed by adding chloride. This produces a characteristic silver gray product. There are no counter ions (such as nitrate or sulphadiazine ions) present: these compounds, found in many silver containing products, are known to retard wound healing. AQUACEL Ag maintains a moist wound-healing environment while, at the same time, killing wound pathogens that are immobilized within the dressing. It also reduces bioburden at the wound-dressing surface, thus minimizing the risk of wound infection and facilitating wound healing.
16288096|NCT00731354|Device|Suction-assisted Lipoplasty|Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back
16288097|NCT00731354|Device|VASER-assisted lipoplasty|VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back
16288098|NCT00731341|Procedure|Cryoablation for the treatment of uterine fibroids|Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.
16288099|NCT00731328|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|infusion of mobilized donor hematopoietic progenitor cells
16288100|NCT00731315|Other|Computer-assisted treatment group|This group will receive computer-assisted expedited treatment for uncomplicated UTI or complicated cystitis based on their symptoms and past medical history reported on the computer.
16288102|NCT00731302|Drug|aspirin and meloxicam|aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily
16288103|NCT00731289|Drug|hyaluronic acid|one intraarticular injection of hyaluronan (HA) 3 ml (Durolane®, 20 mg/ml non-animal stabilized hyaluronic acid (NASHA) in buffered physiological sodium chloride solution pH 7 in one pre-filled glass syringe in sterile pack
16288104|NCT00731289|Drug|triamcinolone|"one intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml)
~antiinflammatory intervention"
16288105|NCT00731276|Drug|irinotecan hydrochloride|
16288106|NCT00731276|Other|pharmacogenomic studies|
16288107|NCT00731276|Other|pharmacological study|
16288108|NCT00731263|Drug|AZD8055|Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.
16288109|NCT00731250|Drug|SB-705498|Subjects will be administered a single dose of 400 mg SB-705498
16288110|NCT00731250|Drug|Placebo|Subjects will be administered SB-705498 matching placebo tablets
16288111|NCT00731250|Other|Caspaicin|Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
16288112|NCT00731224|Drug|Rivastigmine transdermal patch|
16288113|NCT00731211|Drug|Pazopanib|800 mg of pazopanib orally each day continuously
16288114|NCT00731198|Drug|Drotaverine hydrochloride|Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
16288115|NCT00731198|Drug|Hyoscine-N-butylbromide|Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
16288116|NCT00731185|Drug|Mometasone Furoate Nasal Spray|MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
16288117|NCT00731185|Drug|Placebo|
16288118|NCT00731172|Drug|glatiramer acetate|20 mg daily subcutaneous injection through week 12
16288119|NCT00731172|Drug|placebo|subcutaneous daiky injection through week 12
16288120|NCT00731159|Biological|sperm capacitation|sperm capacitation measured at Bar Ilan University
16288121|NCT00731159|Other|biologic|sperm synthesis of G-actine to F-actine
16288122|NCT00731159|Other|sperm capacitation|sperm synthesis of G-actine to F-actine
16288123|NCT00731146|Other|Ultrasound Minimum Effective Anesthetic Volume|Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.
16288124|NCT00731146|Other|Nerve Stimulator Minimum Effective Anesthetic Volume|Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.
16288125|NCT00731133|Drug|Disulfiram|250 mg/day
16288126|NCT00731120|Drug|Vortioxetine|Encapsulated vortioxetine immediate-release tablets
16288127|NCT00731120|Drug|Placebo|Vortioxetine placebo-matching capsules
16288128|NCT00731107|Procedure|laparoscopic surgery|XCEL bladeless trocar laparoscopic entry
16288129|NCT00731107|Procedure|laparoscopic surgery|Veress Needle laparoscopic entry
16288130|NCT00731094|Behavioral|Expert system-based physical activity counseling|The intervention included 14 mailings to participants that involved completion of physical activity questionnaires printed on forms that were scanned into a computerized expert system program to generate individually-tailored feedback messages and related manuals based on the Stages of Motivational Readiness for Change Model. Newsletters providing additional support and suggestions for increasing physical activity were also part of the mailing program.
16288131|NCT00731068|Biological|PRGF|injection of 6cc into injured area of tendon
16288132|NCT00731068|Biological|placebo|injection of 6 cc of saline into injured area
16288133|NCT00731055|Drug|Varenicline|4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.
16288134|NCT00731055|Drug|Placebo|1 dose of placebo
16288135|NCT00731042|Drug|Avagard|Topical solution, 6 mL, 6 applications/day for 14 days.
16288136|NCT00731042|Drug|Purell Surgical Scrub|Topical solution, 4 mL, 6 applications/day for 14 days.
16288137|NCT00731029|Biological|Thiomersal free trivalent influenza split vaccine 2002/2003|Single dose, intramuscular injection
16288138|NCT00731029|Biological|GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003|Single dose, intramuscular injection
16288139|NCT00731016|Drug|Zoledronic acid, pravastatin|"Pravastatin : 10 mg daily
~Zoledronic acid : slow (30 mn) intravenous injections, diluted into 50 ml of saline solution following this schedule :
~injection 1, S1: 0.0125 mg/kg of zoledronic acid
~injection 2, S6: 0.025 mg/kg of zoledronic acid
~injection 3, S12 and following, trimestrial basis, 0.05 mg/kg of zoledronic acid"
16288140|NCT00731003|Drug|Oxitriptan|100 mg 5-Hydroxytryptophan will be administered orally.
16288141|NCT00731003|Other|Acute tryptophan depletion|Acute tryptophan depletion employs the oral ingestion of an amino acid mixture devoid of tryptophan, the precursor of serotonin, which results in lowered serotonin levels.
16288142|NCT00731003|Other|Amino acid drink with tryptophan|Amino acid drink with tryptophan, placebo for the ATD procedure
16288143|NCT00731003|Drug|Placebo capsule|Placebo for 5-HTP
16288144|NCT00730990|Other|Positron Emission tomography|Positron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
16288145|NCT00730990|Drug|PET Scan with PF-03654746|If none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
16288146|NCT00730990|Drug|PET Scan with PF-03654746|If none of the data from the previous interventions are informative, then: 3) an additional 3 patients will receive 2 scans on Day 1 and 1 scan on Day 2 following three different doses of PF-0365476. Doses will be determined based upon the outcomes of the previous interventions.
16288147|NCT00730990|Drug|PET Scan with PF-03654746|"Part 2 of the study will have 3 possible interventions:
~1) 3 subjects in Cohort 2 will receive 2 scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746 (0.5 mg, 1.5 mg, 4 mg)."
16288148|NCT00730977|Drug|dry powder inhaled mannitol|single doses of 40 mg, 70 mg and 100 mg
16288149|NCT00730964|Drug|Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)|"The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed.
~The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) .
~The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study."
16288150|NCT00730951|Dietary Supplement|Korean Red Ginseng|500mg Capsulated Ground Dried Korean Red Ginseng Root
16288151|NCT00730951|Dietary Supplement|Corn Starch|500mg Capsulated Corn Starch
16288152|NCT00730938|Drug|cefuroxime|intracameral cefuroxime 0.1 ml
16288153|NCT00730938|Drug|Saline placebo|0.1 ml of Ringers lactate
16288154|NCT00730925|Drug|BIBW2992|tablet BIBW high dose
16288155|NCT00730925|Drug|BIBW2992 + paclitaxel|tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly
16288156|NCT00730912|Drug|loratadine|Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks
16288157|NCT00730912|Drug|loratadine|loratadine 10 mg tablet once daily for 4 weeks
16288158|NCT00730912|Drug|loratadine|loratadine 10 mg tablet once daily for 4 weeks
16288159|NCT00730886|Device|ExAblate 2000|Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
16288160|NCT00730886|Procedure|Myomectomy|Invasive surgical procedure for fibroid removal
16288161|NCT00730873|Device|Continuous positive airway pressure|
16288162|NCT00730860|Procedure|radiofrequency ablation associated with TACE|treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
16288163|NCT00730860|Procedure|radiofrequency ablation only|treatment of hepatocellular carcinoma by radiofrequency ablation only
16288164|NCT00730847|Biological|Cervarix|Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.
16288165|NCT00730834|Device|Oasis|Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
16288166|NCT00730821|Drug|BIBW 2992|
16288167|NCT00730821|Drug|BIBF 1120|
16288168|NCT00730808|Dietary Supplement|PreOP Booster (food for special medical purposes)|3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
16288169|NCT00730795|Biological|GSK's candidate Mycobacterium tuberculosis vaccine 692342|Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
16288170|NCT00730782|Biological|PfAMA-1-FVO[25-545]|Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
16288171|NCT00730769|Drug|Single arm (ganciclovir and valganciclovir)|Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)
16288172|NCT00730756|Drug|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray 110mcg intranasally once daily for 4 weeks
16288173|NCT00730756|Other|Placebo Nasal Spray|Matching placebo nasal spray intranasally once daily for 4 weeks
16288174|NCT00730743|Procedure|Intermittent Pringle maneuver|Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.
16288175|NCT00730730|Device|Complete SE Iliac Stent|Iliac stenting
16288176|NCT00730730|Device|Complete SE Iliac Stent|Self-expanding stent
16288177|NCT00730717|Drug|Humira|Will receive 80 mg of Humira injection at week 0 followed by 40 mg weekly Humira injection from Week 1 to Week 23
16288178|NCT00730717|Drug|Humira|Will receive 40 mg Humira injection every other week from Week 0 to Week 23
16288179|NCT00730691|Drug|Placebo|Placebo-matching capsules
16288180|NCT00730691|Drug|Vortioxetine|Encapsulated vortioxetine immediate release tablets
16288181|NCT00730691|Drug|Duloxetine|Overencapsulated duloxetine capsules
16288182|NCT00730665|Drug|PF-00885706|Capsule, 100ug, every 12 hours (twice a day)
16288183|NCT00730665|Drug|Esomeprazole|Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
16288184|NCT00730665|Drug|PF-00885706|Capsule, 300ug, every 12 hours (twice a day)
16288185|NCT00730665|Drug|Esomeprazole|Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
16288186|NCT00730665|Drug|PF-00885706|Capsule, 1mg, every 12 hours (twice a day)
16288187|NCT00730665|Drug|Esomeprazole|Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
16288188|NCT00730665|Drug|PF-00885706|Capsule, 3mg, every 12 hours (twice a day)
16288189|NCT00730665|Drug|Esomeprazole|Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
16288190|NCT00730665|Other|Placebo|Capsule, Placebo, every 12 hours (twice a day)
16288409|NCT00729183|Drug|Placebo|Matching placebo tablets to odanacatib taken orally once weekly for 24 months.
16288191|NCT00730665|Drug|Esomeprazole|Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.
16288192|NCT00730652|Biological|MDX-1411|Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses.
16288193|NCT00730639|Biological|BMS-936558 (MDX-1106)|Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
16288194|NCT00730639|Biological|BMS-936558 (MDX-1106)|Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
16288195|NCT00730639|Biological|BMS-936558 (MDX-1106)|Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
16288196|NCT00730639|Biological|BMS-936558 (MDX-1106)|Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
16288197|NCT00730639|Biological|BMS-936558 (MDX-1106)|Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
16288198|NCT00730626|Dietary Supplement|Yogurt with 1X10E9 BB-12 and LA-5|100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E9 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.
16288199|NCT00730626|Dietary Supplement|Yogurt with 1X10E10 BB-12 and LA-5|100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E10 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.
16288200|NCT00730626|Dietary Supplement|Yogurt Placebo|100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
16288201|NCT00730613|Biological|therapeutic autologous lymphocytes|Cycles of escalating cell dose infusions up to the target cell dose of 10(8)
16288202|NCT00730613|Genetic|gene expression analysis|At the time of excess pathology samples documenting response/relapse
16288203|NCT00730613|Other|laboratory biomarker analysis|CSF generated at the time of each T-cell dose
16288204|NCT00730600|Procedure|Thai Traditional massage|Thai traditional massage for 2 hours by a single masseuse.
16288205|NCT00730574|Dietary Supplement|Vitamin B12 + Folic Acid|Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid
16288206|NCT00730561|Biological|Hematopoietic stem cell transplantation|Intramuscular application of CD34+ hematopoietic stem cells (with a minimum of 2 million CD34+ cells/kg) into the gastrocnemius muscles after stimulation with subcutaneous filgrastim 600 micrograms/kilogram a day for 4 days
16288207|NCT00730548|Behavioral|Device triggered remote telephone contact because of Care Alert|Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed
16288208|NCT00730535|Drug|Tolterodine|Extended release tolterodine tartrate 4 mg, once daily, for 1 months
16288209|NCT00730535|Drug|Tolterodine|Extended release tolterodine tartrate 4 mg, once daily, for 3 months
16288210|NCT00730535|Drug|Tolterodine 6|Extended release tolterodine tartrate 4 mg, once daily, for 6 months
16288211|NCT00730522|Drug|CPP-109 vigabatrin|tablets, bid for 12 weeks
16288212|NCT00730522|Drug|Matching Placebo|tablets, bid, 12 weeks
16288213|NCT00730509|Dietary Supplement|5-methyltetrahydrofolate and vitamin B12|children with cystic fibrosis were supplementated for 6 months with 5-MTHF, 7,5 mg/day ; vitamin B12, 0,5 mg/day
16288214|NCT00730496|Procedure|uterine cavity injection of day 2 embryo culture supernatant|On the day 2, the embryos were translated from the old dish to a new dish with fresh media and cultured continuously. In study group, the embryo culture supernatant at the old dish were aspirated by using embryo transfer catheter (COOK-5000, Australia) and injected into the patient's uterine cavity. But in the control group, this intervention was not done. Conventional ET was performed on the third day of embryo culture for both groups.
16288215|NCT00730483|Drug|PVA microporous hydrospheres/doxorubicin hydrochloride|
16288216|NCT00730470|Drug|U3-1287 (AMG888)|IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients
16288217|NCT00730457|Biological|VAX125|Single intramuscular dose
16288218|NCT00730444|Drug|Iobenguane I 123 Injection|1-10 mCi administered intravenously
16288219|NCT00730431|Drug|IDX184|IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
16288220|NCT00730431|Drug|Placebo|Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.
16288221|NCT00730418|Drug|Doxazosin|Treatment with doxazosin 4mg daily for 24 mos
16288222|NCT00730418|Drug|Doxazosin|Treatment with doxazosin 8mg daily for 24 mos
16288223|NCT00730405|Drug|Albaconazole 100mg|Albaconazole for 36 weeks
16288224|NCT00730405|Drug|Albaconazole 200mg|Albaconazole for 36 weeks
16288225|NCT00730405|Drug|Albaconazole 400mg|Albaconazole for 36 weeks
16288226|NCT00730405|Drug|Albaconazole 400mg|Albaconazole for 24 weeks, Placebo for 12 weeks
16288227|NCT00730405|Drug|Placebo 400 mg|Placebo for 36 weeks
16288228|NCT00730392|Drug|Etanercept|The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly
16288229|NCT00730392|Drug|Placebo|administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly
16288230|NCT00730379|Drug|Comparator: ridaforolimus + dalotuzumab|Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).
16288231|NCT00730366|Drug|sulfadoxine-pyrimethamine|Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
16288232|NCT00730366|Drug|Chloroquine|Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week
16288233|NCT00730353|Drug|Sunitinib malate|Sunitinib malate 37.5 mg orally, daily
16288234|NCT00730353|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
16288410|NCT00729183|Drug|Vitamin D3|Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.
16289500|NCT00720720|Dietary Supplement|placebo margarine|
16288235|NCT00730340|Procedure|Closure of the Tonsillar Fossa|We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.
16288236|NCT00730340|Procedure|Tonsillectomy with open fossa|SOP for a tonsillectomy.
16288237|NCT00730327|Device|BioEnterics® Intragastric Balloon|Inflatable balloon inserted into the stomach.
16288238|NCT00730327|Other|Behavioral modification|Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
16288239|NCT00730314|Procedure|Hematopoietic stem cell transplantation|hematopoietic stem cell transplantation conditioning regimen depending on graft source
16288240|NCT00730301|Procedure|Bronchoscopic Lung Volume Reduction (BLVR)|Procedure under general anesthesia.
16288241|NCT00730288|Biological|Chimeric dengue serotype (1, 2, 3, 4)|0.5 mL, Subcutaneous, 1 dose
16288242|NCT00730288|Biological|Chimeric dengue serotype (1, 2, 3, 4)|0.5 mL, Subcutaneous, 1 dose
16288243|NCT00730288|Biological|Chimeric dengue serotype (1, 2, 3, 4)|0.5mL, Subcutaneous, 1 dose
16288244|NCT00730275|Drug|Sitagliptin phosphate|Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.
16288245|NCT00730275|Drug|Comparator: matching placebo|Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
16288246|NCT00730262|Drug|TLN-4601|14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
16288247|NCT00730249|Drug|methylphenidate hydrochloride|sustained release, twice daily, dosage according to an individual titration schedule
16288248|NCT00730249|Drug|Placebo|twice daily according to an individual titration schedule
16288249|NCT00730236|Drug|AEGR-733|5-80 mg daily by mouth for 1.5 yrs
16288250|NCT00730223|Drug|Nevirapine and Efavirenz|single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
16288251|NCT00730210|Drug|a: PTH (1-84)|preotact 100 microgram subcutaneous a day in 6 months
16288252|NCT00730210|Drug|b:placebo|100 microgram placebo subcutaneous a day for 6 months
16288253|NCT00730197|Drug|Albuterol Sulfate Extended-Release Tablets 8 mg|8mg, single dose fed
16288254|NCT00730197|Drug|VoSpire® ER Tablets 8 mg|8mg, single dose fed
16288255|NCT00730184|Dietary Supplement|potassium bicarbonate|90 mmol/d given as 4 tablets after each meal, with a full glass of water
16288256|NCT00730184|Dietary Supplement|Placebo (microcrystalline cellulose)|Given as 4 tablets after each meal, with a full glass of water
16288257|NCT00730171|Drug|Linaclotide|Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
16288258|NCT00730158|Drug|KD018|Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
16288259|NCT00730158|Drug|Irinotecan|Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
16288260|NCT00730158|Drug|Placebo|Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
16288261|NCT00730145|Drug|PD-0332334|A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
16288262|NCT00730132|Drug|Ezetimibe|Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
16288263|NCT00730132|Drug|Statin|Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
16288264|NCT00730093|Dietary Supplement|B12 vitamin (Cyanocobalamin)|Arm A: B12 vitamin (Cyanocobalamin)
16288265|NCT00730080|Drug|Sapropterin (Kuvan)|20mg/kg/day taken once daily or as otherwise prescribed by physician as standard care.
16288266|NCT00730067|Drug|sildenafil|Sildenafil 50 mg three times daily
16288267|NCT00730067|Drug|placebo|tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.
16288268|NCT00730054|Drug|Remifentanil+clonidine|iv Remifentanil+ iv clonidine
16288269|NCT00730041|Device|Pillar Palatal Implant System|The Pillar system is intended as an initial treatment option for mild to moderate OSA. It consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implant within the soft palate of the mouth. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The implant is pre-loaded into the needle. Three implants are placed in each subject under local anesthesia. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.
16288270|NCT00730041|Device|Sham system|The Pillar system consists of a delivery system and an implant. The only difference between the treatment and sham arm in this study is that the sham delivery device is not pre-loaded with the implant. Otherwise the appearance, manufacturing and function of the delivery devices are identical. Three insertions are made, but no implants are actually deployed during the procedure. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.
16288271|NCT00730028|Drug|Trimethoprim-sulfamethoxazole|Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose). Study drug will be administered for 10 days.
16288272|NCT00730028|Other|Placebo|Placebo capsules will be identical in appearance to the CLINDA and TMP-SMX. Administered 3 times daily for 10 days.
16288273|NCT00730028|Drug|Clindamycin|CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day). Study drug will be administered for 10 days.
16288274|NCT00730015|Drug|Matching Placebo|Oral, once daily
16288275|NCT00730015|Drug|Linaclotide|Oral, once daily
16288276|NCT00730002|Procedure|Magnetic Resonance Angiography (MRA)|As part of the Magnetic Resonance(MR) scan, you will need to lie still on a padded MR table inside the MR machine for about 15 minutes at a time while MR studies are being performed on you. The total time for the clinical portion of the MR study is approximately 35-40 minutes and there will be an additional 30 minutes for the research related MR studies. The total time you will spend on the MR table for this research will seldom be more than one hour.
16288277|NCT00730002|Procedure|Magnetic resonance imaging|MR spectroscopy
16288278|NCT00730002|Procedure|MRA|MRA of the brain
16288279|NCT00730002|Procedure|MRA|
16288280|NCT00730002|Procedure|diffusion Imaging|MRA of the Brain
16288281|NCT00730002|Procedure|perfusion imaging.|MRA of the brain
16288282|NCT00729989|Procedure|Gastric suctioning|The stomach will be suctioned shortly following birth with an orogastric tube
16288283|NCT00729976|Drug|Ibuprofen suppository|5-10mg/Kg of ibuprofen
16288284|NCT00729976|Drug|Ibuprofen Suspension|5-10mg/Kg
16288285|NCT00729963|Drug|Sibutramine|The first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (< 1.8 kg) over the first month of treatment.
16288286|NCT00729963|Device|CPAP|
16288287|NCT00729950|Biological|MDX-010|Subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.
16288288|NCT00729937|Drug|Cephalexin|500 mg, four times per day.
16288289|NCT00729937|Drug|Clindamycin|300 mg, four times per day.
16288290|NCT00729937|Other|Placebo|Placebo tablet administered orally.
16288291|NCT00729937|Drug|Trimethoprim-sulfamethoxazole|4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
16288292|NCT00729924|Drug|Raltegravir|400mg orally every 12 hours for 7 days
16288293|NCT00729911|Procedure|Atrial Fibrillation ablation|Radio-frequency catheter ablation of atrial fibrillation
16288294|NCT00729911|Drug|Amiodarone|Taken orally on a daily basis.
16288295|NCT00729898|Drug|biphasic insulin aspart 30|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16288296|NCT00729885|Device|Goggle with 20 degree error|The Vertigone Goggle is modified such that the head positions and visual feedback indicators are offset 20° from the classic Epley positions.
16288297|NCT00729885|Device|Optimized Goggle|The classic Epley maneuver involves 3 head positions: 1) the patient supine, the neck is extended 20°and the head turned 45° towards the affected ear, 2) the patient rotates his head 90° to the contralateral side, with the final head position 45° from vertical, 3) the patient turns his head 135° towards the floor on the contralateral side. For the classic Epley maneuver, the goggle coach ball markings will be set for correct positioning.
16288298|NCT00729872|Biological|AG011|Capsules (low, mid or high dose), twice daily for 28 days, combined with Enema (low, mid or high dose respectively), once daily for 28 days.
16288299|NCT00729872|Other|Placebo|Capsules (matching placebo for low, mid or high dose), twice daily for 28 days, combined with Enema (matching placebo for low, mid or high dose respectively), once daily for 28 days.
16288300|NCT00729859|Drug|Acyline|Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days
16288301|NCT00729859|Drug|Acyline + Testosterone gel|Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days
16288302|NCT00729859|Drug|Acyline + testosterone gel + anastrozole|Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days
16288303|NCT00729846|Drug|Bevacizumab|Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
16288304|NCT00729846|Device|verteporfin photodynamic therapy reduced fluence|Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].
16288305|NCT00729846|Device|verteporfin photodynamic therapy standardfluence|Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].
16288306|NCT00729833|Drug|CP-751,871|CP-751,871 IV, every 3 weeks
16288307|NCT00729833|Drug|Sunitinib|Sunitinib - daily dosing
16288308|NCT00729807|Drug|pentamidine|
16288309|NCT00729794|Drug|Vasopressin, Epinephrine, Methylprednisolone, Hydrocortisone|"Combination Treatment
~Administration of vasopressin, epinephrine, and methylprednisolone during CPR, and of stress dose hydrocortisone after CPR"
16288310|NCT00729794|Drug|Standard CPR Protocol with Epinephrine and two Placebos|Patients receive advanced life support according to the Guidelines for Resuscitation 2005
16288311|NCT00729781|Device|Polyester Implants|Three polyester (PET) implants will be implanted in each side of the nose affected by external NVC. See the detailed description for information about the implant procedure.
16288312|NCT00729768|Drug|basiliximab|2 intravenous doses
16288313|NCT00729768|Drug|efalizumab|Subcutaneous repeating dose
16288314|NCT00729768|Drug|mycophenolate mofetil|Oral repeating dose
16288315|NCT00729768|Drug|corticosteroids|Repeating doses
16288316|NCT00729768|Drug|cyclosporine|Oral repeating dose
16288317|NCT00729755|Dietary Supplement|Creatine monohydrate|In addition to 10-20mg escitalopram, the subjects will be given total 3 gram of creatine (500mg/capsule) a day in first week and then, 5 gram a day in the rest of the weeks.
16288318|NCT00729755|Dietary Supplement|Placebo|In addition to 10-20mg escitalopram, the subjects will be given total 6 capsules of placebo (equal quantities to those of creatine group) a day in first week and then, 10 capsules a day in the rest of the weeks.
16288411|NCT00729183|Drug|Calcium supplement|Calcium supplement 500 mg tablet taken orally once daily (up to ~1200 mg total) for 24 months.
16288412|NCT00729170|Dietary Supplement|Supplementation of milk (35% more calcium)|The supplement provides 1000 mg of calcium and 250 kcal daily.
16288413|NCT00729157|Radiation|Fludeoxyglucose F-18|Correlative studies
16288414|NCT00729157|Other|Laboratory Biomarker Analysis|Correlative studies
16288319|NCT00729742|Drug|Comparator: erlotinib + dalotuzumab|"Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.
~Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.
~Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib."
16288320|NCT00729742|Drug|Comparator: erlotinib monotherapy|Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
16288321|NCT00729729|Drug|PCA|Placebo tablet, once
16288322|NCT00729729|Drug|PCA|PO, 700mg, once
16288323|NCT00729729|Drug|PCA|PO, 1000mg, once
16288324|NCT00729716|Biological|BioCart™II|A cartilage biopsy will be harvested from patients during arthroscopy and used for chondrocyte isolation, culture and future implantation. Subjects will also have about 80 ml venous blood drawn for autologous cell culture medium. Two-four weeks following biopsy harvest, BioCart™II will be implanted into the cartilage defect after careful debridement via miniarthrotomy.
16288325|NCT00729716|Procedure|Microfracture|MF procedure will be carried out according to accepted practice. After careful debridement multiple perforations, or microfractures, are made in the subchondral bone using an awl. The released bone marrow forms a clot at the lesion site which is an enriched environment for new tissue formation. With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn. This will be used for chondrocyte culture and cryopreservation in case a later BioCart™II implantation is required after failure of the microfracture procedure.
16288326|NCT00729703|Device|Ovatio DR 6550|Dual-chamber ICD therapy with minimized ventricular pacing
16288327|NCT00729703|Device|OVATIO DR 6550|Single-chamber device therapy with settings which are common in clinical practice.
16288328|NCT00729690|Drug|Pregabalin|"Group 1 (n=16, multi-dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
~Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
~Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2."
16288329|NCT00729690|Drug|Pregabalin|Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
16288330|NCT00729690|Drug|Placebo|Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.
16288331|NCT00729664|Biological|Anti-PDL-1 antibody|Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
16288332|NCT00729664|Biological|Anti-PDL-1 antibody|Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
16288333|NCT00729664|Biological|Anti-PDL-1 antibody|Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
16288334|NCT00729664|Biological|Anti-PDL-1 antibody|Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
16288335|NCT00729664|Biological|Anti-PDL-1 antibody|Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
16288336|NCT00729651|Drug|alendronate sodium (+) cholecalciferol|Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
16288337|NCT00729651|Drug|Comparator: Alendronate sodium (Fosamax)|Alendronate sodium; tablet, once weekly, for 16 weeks
16288338|NCT00729651|Dietary Supplement|Comparator: Calcium|500 mg oral tablet calcium once daily, for 16 weeks
16288339|NCT00729638|Drug|RAD001|Dose levels will change: Taken orally either every other day for the first three weeks of each cycle or taken every day for the first three weeks of each cycle.
16288340|NCT00729638|Drug|lenalidomide|Dose level will vary: taken orally 30-60 minutes after taking RAD001 every day for the first three weeks of each cycle.
16288341|NCT00729625|Device|robotic device|"The device has a small air muscle that when activated will slowly lift their fingers and wrist from your resting wrist position. This device is classified as a non-significant risk device by the FDA (see attached letter dated 1-15-05). The patient should not experience any pain or discomfort during this stretching activity. If they do experience any pain or discomfort they can activate a stop switch located on the control box with their unimpaired hand."
16288342|NCT00729612|Drug|carboplatin|
16288343|NCT00729612|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16288344|NCT00729612|Genetic|protein expression analysis|
16288345|NCT00729612|Other|immunoenzyme technique|
16288346|NCT00729612|Other|immunohistochemistry staining method|
16288347|NCT00729612|Other|laboratory biomarker analysis|
16288348|NCT00729599|Drug|Cetylpyridinium chloride|Cetylpyridinium chloride during 21 consecutive days.
16288349|NCT00729586|Other|Laboratory Biomarker Analysis|Correlative studies
16288350|NCT00729586|Drug|Megestrol Acetate|Given PO
16288351|NCT00729586|Drug|Tamoxifen Citrate|Given PO
16288352|NCT00729586|Drug|Temsirolimus|Given IV
16288353|NCT00729573|Drug|Emtricitabine/tenofovir disoproxil fumarate|200 mg/300 mg tabletas a part of MTN-003
16288354|NCT00729573|Drug|Emtricitabine/tenofovir disoproxil fumarate placebo|placebo tablet as a part of MTN-003
16288355|NCT00729573|Drug|Tenofovir disoproxil fumarate|300 mg tablet as a part of MTN-003
16288356|NCT00729573|Drug|Tenofovir disoproxil fumarate placebo|placebo tablet as a part of MTN-003
16288357|NCT00729560|Drug|Flutamide|250 mg twice daily for 4 weeks
16288358|NCT00729560|Drug|Placebo|Placebo twice daily for 4 weeks
16288359|NCT00729547|Behavioral|Neurofeedback|enhance relative activity level of left frontal activity
16288360|NCT00729547|Behavioral|Psychotherapy placebo|These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
16288415|NCT00729157|Other|Pharmacological Study|Correlative studies
16288416|NCT00729157|Procedure|Positron Emission Tomography|Correlative studies
16288417|NCT00729157|Biological|Ziv-Aflibercept|Given IV
16288361|NCT00729521|Other|facilitative system|The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation.
16288362|NCT00729521|Other|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
16288363|NCT00729508|Biological|Cat-PAD|Cat-PAD dose 2X 4 administrations 2 weeks apart
16288364|NCT00729508|Biological|Cat-PAD|Cat-PAD dose 1X 4 administrations 2 weeks apart
16288365|NCT00729508|Biological|Cat-PAD|Cat-PAD dose 1X 4 administrations 4 weeks apart
16288366|NCT00729508|Biological|Cat-PAD|Cat-PAD dose 1X 8 administrations 2 weeks apart
16288367|NCT00729508|Biological|Cat-PAD|Placebo
16288368|NCT00729495|Drug|celecoxib|dose form
16288369|NCT00729482|Drug|RAD001|RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
16288370|NCT00729469|Drug|Ospemifene 60 mg|60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
16288371|NCT00729469|Drug|Placebo|oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
16288372|NCT00729456|Other|Education|Patients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes.
16288373|NCT00729443|Drug|AZD3241|single oral dose
16288374|NCT00729443|Drug|Placebo|
16288375|NCT00729430|Drug|Omega-3 Fatty Acids (Fish Oil Supplements)|4 grams of omega-3 fatty acids taken orally once per day for 6 months
16288376|NCT00729430|Drug|Placebo|Placebo tablets taken orally once per day for 6 months
16288377|NCT00729404|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
16288378|NCT00729404|Drug|Ethinylestradiol/Gestodene (BAY86-5016)|transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles
16288379|NCT00729391|Behavioral|Woman-Focused Intervention (Women's Health CoOp)|Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
16288380|NCT00729391|Behavioral|Nutrition (Attention-Control)|Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
16288381|NCT00729391|Behavioral|VCT Only|Participants in this group will receive VCT only.
16288382|NCT00729378|Other|Skeletal loading|Impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
16288383|NCT00729365|Drug|Ramipril|"ACE inhibitor known as Ramipril
~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
16288384|NCT00729365|Drug|Placebo|Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group.
16288385|NCT00729365|Drug|Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
16288386|NCT00729339|Drug|mosapride for the first month and placebo for the 2nd month|lansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month
16288387|NCT00729339|Drug|placebo for the first and mosapride for the second month|lansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month
16288388|NCT00729326|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
16288389|NCT00729326|Drug|sitagliptin|oral administration (100mg), once a day in the morning
16288390|NCT00729326|Drug|placebo|subcutaneous injection (5mcg or 10mcg), twice a day
16288391|NCT00729326|Drug|placebo|oral administration (100mg), once a day in the morning
16288392|NCT00729313|Drug|Lanreotide microparticles|
16288393|NCT00729313|Drug|Placebo|
16288394|NCT00729300|Drug|placebo|placebo daily
16288395|NCT00729300|Drug|disulfiram|250mg daily
16288396|NCT00729287|Dietary Supplement|selenium|Given orally
16288397|NCT00729287|Other|placebo|Given orally
16288398|NCT00729274|Drug|normal saline solution|Two 4ml nebulizations with 30 minute interval
16288399|NCT00729261|Procedure|extubation|Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.
16288400|NCT00729261|Procedure|continued intubation|patients remain intubated until their Glasgow coma scores improve to greater than 8.
16288401|NCT00729235|Device|Ovatio CRT 6750|"Slow VT zone programmed as a Monitoring zone (Monitoring arm)"
16288402|NCT00729235|Device|Ovatio CRT 6750|Slow VT zone programmed with ATP therapies (therapy arm).
16288403|NCT00729222|Drug|Comparator: Placebo|rolofylline placebo IV infusion over 4 hours.
16288404|NCT00729222|Drug|rolofylline|rolofylline 30 mg IV infusion over 4 hours.
16288405|NCT00729209|Drug|ARRY-371797, p38 inhibitor; oral|multiple dose, single schedule
16288406|NCT00729209|Drug|Placebo; oral|matching placebo
16288407|NCT00729196|Behavioral|Lifestyle Modification|Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
16289565|NCT00720356|Drug|erlotinib hydrochloride|150 mg/daily orally
16288418|NCT00729131|Drug|Etanercept inhibition of ozone-induced airway hyper-responsiveness.|Single dosage of etanercept(50 mg, subcutaneous) given 2 days prior to a laboratory ozone exposure.
16288419|NCT00729118|Drug|lenalidomide|combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
16288420|NCT00729118|Drug|vorinostat|Vorinostat (SAHA) will be administered orally beginning at dose level 1 starting day +90 ±6 days after HSCT for days 1 and 15-21 of a 28-day cycle combined with lenalidomide days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
16288421|NCT00729079|Behavioral|DPP|"The primary outcome measure is weight loss with a goal of 7% of initial weight.
~Secondary outcomes are adherence to behavior changes:
~Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
~Fat intake less than 25% and saturated fat less than 10%
~Fiber intake of at least 25 grams per day
~Fasting blood sugar < 100 mg/dL
~Absence of tobacco use"
16288422|NCT00729079|Behavioral|DPP|"The primary outcome measure is weight loss with a goal of 7% of initial weight.
~Secondary outcomes are adherence to behavior changes:
~Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
~Fat intake less than 25% and saturated fat less than 10%
~Fiber intake of at least 25 grams per day
~Fasting blood sugar < 100 mg/dL
~Absence of tobacco use"
16288423|NCT00729053|Drug|IMO-2055|immunostimulatory oligonucleotide
16288424|NCT00729040|Behavioral|Stepping Up to Health|Internet-mediated walking program with pedometers, goal-setting and tailored messaging
16288425|NCT00729027|Drug|25 mg/day AVE5530|"one tablet in the evening with dinner
~in addition to statin treatment (HMG-CoA Reductase Inhibitors)"
16288426|NCT00729027|Drug|50 mg/day AVE5530|"one tablet in the evening with dinner
~in addition to statin treatment (HMG-CoA Reductase Inhibitors)"
16288427|NCT00729027|Drug|placebo|"one tablet in the evening with dinner
~in addition to statin treatment (HMG-CoA Reductase Inhibitors)"
16288428|NCT00729001|Biological|Human Rotavirus Vaccine - two different formulations|Two oral doses
16288429|NCT00729001|Biological|Prevnar|Three-dose intramuscular injection (US subjects only)
16288430|NCT00729001|Biological|IPOL|Two-dose intramuscular injection (US subjects only)
16288431|NCT00729001|Biological|Infanrix|Three-dose intramuscular injection (US subjects only)
16288432|NCT00729001|Biological|OmniHIB|Three-dose intramuscular injection (US subjects only)
16288433|NCT00729001|Biological|Pentacel|Three-dose intramuscular injection (Canada only)
16288434|NCT00728988|Drug|Atorvastatin|80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.
16288435|NCT00728988|Drug|Atorvastatin|40mg daily after PCI for 30 days.
16288436|NCT00728949|Biological|IMC-A12 (cixutumumab)|10 mg/kg I.V.
16288437|NCT00728949|Drug|tamoxifen|Daily 20 mg, oral
16288438|NCT00728949|Drug|Anastrozole|Daily 1 mg, oral
16288439|NCT00728949|Drug|Letrozole|Daily 2.5 mg, oral
16288440|NCT00728949|Drug|Exemestane|Daily 25 mg, oral
16288441|NCT00728949|Drug|Fulvestrant|Monthly 250 mg, intramuscularly
16288442|NCT00728936|Drug|IMO-2125|IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system
16288443|NCT00728936|Drug|Saline placebo|saline placebo given subcutaneously
16288444|NCT00728923|Drug|NPL-2003|Minocycline (NPL-2003) daily for 12 weeks
16288445|NCT00728910|Drug|Atorvastatin|10 mg QD for 4 weeks
16288446|NCT00728910|Drug|ABT335|135 mg QD added to atorvastatin for 8 weeks
16288447|NCT00728910|Drug|ER Niacin|2000 mg QD added to atorvastatin and ABT335 for 10 weeks
16288448|NCT00728897|Drug|GSK598809 new formulation|GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
16288449|NCT00728897|Drug|GSK598809 old formulation|GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
16288450|NCT00728871|Procedure|peripheral blood isolation|To isolate serum from patient peripheral blood to test the titer of HPV infection and cytokine expression
16288451|NCT00728845|Biological|bevacizumab|Only patients eligible for bevacizumab will receive bevacizumab. Dose is at 15 mg/kg on day 1 of each cycle.
16288452|NCT00728845|Drug|carboplatin|Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel
16288453|NCT00728845|Drug|hydroxychloroquine|200 mg orally BID (total daily dose of 400 mg)
16288454|NCT00728845|Drug|paclitaxel|Dose of 200 mg/m2 IV on day 1 of each cycle
16288455|NCT00728832|Drug|DepoDur (extended-release epidural morphine)|DepoDur with on demand boluses of IV fentanyl PCA
16288456|NCT00728819|Device|Tapered PICC|Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
16288457|NCT00728819|Device|Non-tapered PICC|Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
16288458|NCT00728793|Drug|CUDC-101|Doses will be given by intravenous infusion over 1 hour on days 1-5 of each treatment cycle. Total treatment cycle duration will be 14 days. Additional treatment cycles will be administered until the subjects withdraws consent, experiences unacceptable toxicity, or if there is documented tumor progression.
16288459|NCT00728780|Drug|ABT-143|once
16288460|NCT00728780|Drug|ABT-335 and rosuvastatin|once
16288461|NCT00728767|Other|Brief intervention|"The intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention.
~The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, and a sheet about local alcohol treatment possibilities.
~The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.
~Employees had been instructed to ask these questions during the intervention: What are you already doing to restrain your drinking? And What can you do more?"
16288502|NCT00728455|Drug|NNC 0070-0002-0349|Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo)
16288462|NCT00728767|Other|Control group|The intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities.
16288463|NCT00728754|Device|Dental implant Osseotite Prevail|Root form titanium dental implant
16288464|NCT00728754|Device|Dental implant Osseotite|root form titanium dental implant
16288465|NCT00728728|Drug|Dietary Supplement: Pregnenolone|Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
16288466|NCT00728728|Dietary Supplement|Placebo|Placebo
16288467|NCT00728715|Drug|budesonide-formoterol single inhaler|High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid
16288468|NCT00728715|Drug|High dose of budesonide|1600 mcg/d of budesonide
16288469|NCT00728715|Drug|A|medium dose of budesonide-formoterol
16288470|NCT00728715|Drug|B|High Dose Inhaled Budesonide
16288471|NCT00728689|Drug|ST-246 Days 1 - 3|First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2).
16288472|NCT00728689|Drug|ST-246 Days 11 - 13|Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.
16288473|NCT00728663|Biological|cetuximab|"Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8
~--- for max. 24 weeks or until progression or unacceptable toxicity ---"
16288474|NCT00728663|Drug|docetaxel|"75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle
~--- for max. 24 weeks or until progression or unacceptable toxicity ---"
16288475|NCT00728637|Behavioral|Family Passport to Heart Health Program|Participants in this group received personalized heart disease risk factor screening at the baseline study visit. They were taught lifestyle approaches to risk reduction based upon national heart disease prevention guidelines, including the Adult Treatment Panel (ATP) III recommendations for improving blood cholesterol levels with a TLC diet. Participants had regular contact with study staff and will receive individualized feedback throughout the study.
16288476|NCT00728637|Behavioral|General Educational Materials|Participants in the control group received an educational brochure about heart health at the baseline study visit.
16288477|NCT00728611|Biological|PRGF|intra auricular injection 6mg
16288478|NCT00728611|Drug|hyaluronic acid|20 mg / 2 ml
16288479|NCT00728611|Drug|placebo|physiological water 3cc + lidocain 3cc
16288480|NCT00728585|Drug|Palifermin|Given IV
16288481|NCT00728585|Other|Placebo|Given IV
16288482|NCT00728572|Procedure|Logan Basic Technique and Surface EMG|Participant will receive a brief Basic Technique and Surface EMG examination and Basic Technique treatment.
16288483|NCT00728572|Other|Surface EMG|Surface EMG only, no intervention
16288484|NCT00728572|Procedure|Logan Basic Technique Sham|Participants will receive a sham Basic Technique treatment, not indicated by examination.
16288485|NCT00728559|Drug|bupivacain 0.5%|trocar site injection
16288486|NCT00728546|Drug|Isoniazid (Rifinah)|The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
16288487|NCT00728533|Drug|Degarelix|Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
16288488|NCT00728533|Drug|Degarelix|Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
16288489|NCT00728520|Drug|Azacitidine|Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.
16288490|NCT00728507|Drug|Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid|Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
16288491|NCT00728507|Drug|Isoniazid, Rifampin, Pyrazinamide, Ethambutol|Administered per standard of care for TB treatment
16288492|NCT00728494|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|Peginterferon alfa-2b will be administered according to the product's labeling.
16288493|NCT00728494|Drug|Rebetol (ribavirin; SCH 18908)|Ribavirin will be administered according to the product's labeling.
16288494|NCT00728494|Behavioral|Patient Assistance Program|"The patient assistance program includes the following:
~Training by physicians or specialized nurses.
~Informational materials based on the To beat HCV program.
~Management of specific side effects."
16288495|NCT00728481|Drug|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks
16288496|NCT00728481|Drug|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
16288497|NCT00728468|Drug|PF-00299804|PF-00299804: Patients take oral 45 mg PF-00299804 once daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicities occur. One cycle equals 21 days. Dextromethorphan: Patient take a single 30 mg oral dose of dextromethorphan HBr three days prior to Cycle 1 Day 1, and then on Cycle 2 Day 7.
16288498|NCT00728455|Drug|NNC 0070-0002-0349|Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288499|NCT00728455|Drug|NNC 0070-0002-0349|Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288500|NCT00728455|Drug|NNC 0070-0002-0349|Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288501|NCT00728455|Drug|NNC 0070-0002-0349|Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo)
16288503|NCT00728455|Drug|placebo|Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288504|NCT00728455|Drug|placebo|Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288505|NCT00728455|Drug|placebo|Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
16288506|NCT00728455|Drug|placebo|Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection
16288507|NCT00728455|Drug|placebo|Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection
16288508|NCT00728442|Device|ONCODOC LOGICIEL|Introduction of a computer-based decision support system in the medical decision process
16288509|NCT00728429|Behavioral|exercise intervention|24 week program of exercise
16288510|NCT00728416|Drug|Mometasone furoate nasal spray (MFNS)|MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
16288511|NCT00728416|Drug|Matching placebo nasal spray|Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
16288512|NCT00728403|Dietary Supplement|American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)|1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
16288513|NCT00728403|Dietary Supplement|American Ginseng (Panax quinquefolius L.)|3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
16288514|NCT00728403|Dietary Supplement|Wheat Bran|3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
16288515|NCT00728390|Drug|PF-00299804|CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.
16288516|NCT00728377|Behavioral|Physical activity|Individually Tailored (IT) Exercise Intervention This intervention is designed to increase the amount of physical activity incorporated into the daily lifestyle of pregnant women, primarily through increased walking, with the ultimate goal of achieving the American College of Obstetricians and Gynecologists (ACOG) exercise goals for pregnant women. These goals are the same as the Surgeon General's Guidelines for physical activity for nonpregnant individuals (30 minutes or more or moderate activity on most days of the week).The intervention includes: 1) individually tailored print-based materials (i.e., individually-tailored reports and stage-matched manuals), 2) self-monitoring materials, and 3) goal setting.
16288517|NCT00728377|Behavioral|Heath & Wellness|The comparison intervention consists of a series of informational booklets published by the American College of Obstetricians and Gynecologists on general issues related to health and wellness during pregnancy. These include alcohol and drug use during pregnancy, easing back pain, as well as the Pregnancy Fitness brochure on the safety of exercise during pregnancy. These booklets are selected to represent high-quality, standard, low-cost, self-help material currently available to the public.
16288518|NCT00728351|Drug|vildagliptin + metformin|
16288519|NCT00728351|Drug|metformin|1000 bid metformin
16288520|NCT00728338|Dietary Supplement|Docosahexenoic acid (DHA)|The DHA group received 7.5 g/d DHA oil (DHA 3.0 g/d) which is produced in the microalga Crypthecodinium cohinii.
16288521|NCT00728338|Dietary Supplement|Olive oil|7.5 g olive oil/day
16288522|NCT00728325|Behavioral|Supported Employment (SE)|SE(IPS)involves: a vocational rehabilitation employment specialist who is integrated into the clinical treatment team, carries out all phases of the vocational services, provides predominantly community-based services, provides assertive engagement and outreach, has a case load of ≤ 25 clients; engages in rapid job search, individualized placement in diverse and potentially permanent competitive job(s), ongoing work-based vocational assessment, and assistance in finding subsequent jobs if needed with the view that all jobs are positive learning experiences; continuous time-unlimited follow-along supports to provide vocational services; and weekly group supervision with IPS/VRP team and with IPS supervisor/trainer monthly.
16288523|NCT00728325|Behavioral|Standard Vocational Rehabilitation (VRP)|Standard Vocational Rehabilitation (VRP) includes 1) the Vocational Assistance Program (includes routine prevocational testing and evaluation for all patients upon referral to VRP), 2) Vocational Rehabilitation Therapy that operates under the Compensated Work Therapy/Veterans Industries (CWT) and provides a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece rate basis related to their production, and 3) Transitional Work Program (TWP) that includes a temporary work experience either within the VAMC or in community settings (called the Transitional Work External or TWE).
16288524|NCT00728312|Drug|Aripiprazole|12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day)
16288525|NCT00728312|Drug|Placebo|12 week comparison of placebo 5-15 mg per day (pill which contains no active medication) versus active medication (aripiprazole 5-15 mg per day)
16288526|NCT00728299|Drug|PomWonderful Juice|8 oz per day each day for 78 weeks
16288527|NCT00728299|Drug|Placebo juice|8 oz per day for 78 weeks
16288528|NCT00728273|Dietary Supplement|worm treatment and multiple micronutrient fortified biscuits|"A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months).
~The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin."
16288529|NCT00728260|Biological|None administered in this study|N/A in this study
16288530|NCT00728247|Procedure|Manual Therapy Techniques|One of the following will be selected(1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method
16288531|NCT00728234|Device|aEEG recording|weekly recordings with aEEG
16288532|NCT00728221|Dietary Supplement|Korean Red Ginseng|"Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
~Dosage form: whole root in capsules (3g)"
16288533|NCT00728221|Dietary Supplement|Korean Red Ginseng (Panax ginseng)|"Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
~Dosage form: total ginsenoside fraction in capsules"
16288534|NCT00728221|Dietary Supplement|Cornstarch|Placebo
16288535|NCT00728221|Dietary Supplement|Korean Red Ginseng (Panax Ginseng)|"Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
~Dosage form: total polysaccharide fraction (panaxans) in capsules"
16288536|NCT00728208|Drug|GSK372475|1.5mg for 28 days
16288537|NCT00728195|Drug|JNJ-37822681|Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.
16288538|NCT00728195|Drug|JNJ-37822681|Participants will receive JNJ-37822681 capsule 20 mg orally twice a day for 12 consecutive weeks.
16288539|NCT00728195|Drug|JNJ-37822681|Participants will receive JNJ-37822681 capsule 30 mg orally twice a day for 12 consecutive weeks.
16288540|NCT00728195|Drug|Olanzapine|Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.
16288541|NCT00728195|Drug|Placebo|Participants will receive matching placebo capsules orally for 12 weeks.
16288542|NCT00728182|Drug|NA-1|single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
16288543|NCT00728182|Drug|Placebo|single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
16288544|NCT00728156|Drug|clopidogrel|75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
16288545|NCT00728156|Drug|placebo|Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
16288546|NCT00728143|Dietary Supplement|Highly viscous polysaccharide enriched biscuits|10 g of highly viscous polysaccharide
16288547|NCT00728130|Procedure|neck dissection of at least the ipsilateral sub-level 1B|neck dissection of at least the ipsilateral sub-level 1B
16288548|NCT00728117|Other|feeding|Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
16288549|NCT00728117|Other|fasting|Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
16288550|NCT00728091|Drug|Satavaptan|tablets
16288551|NCT00728091|Drug|placebo|tablets
16288552|NCT00728078|Drug|thalidomide|thalidomide 50mg tid for 6 months
16288553|NCT00728065|Dietary Supplement|White Bread|About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
16288554|NCT00728065|Dietary Supplement|White bread with added 7.32g Salvia hispanica|About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
16288555|NCT00728065|Dietary Supplement|White bread with added 15.58g Salvia hispanica|About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
16288556|NCT00728065|Dietary Supplement|White bread with added Salvia hispanica|About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
16288557|NCT00728065|Dietary Supplement|Rice milk|Rice milk containing 50g of available carbohydrates
16288558|NCT00728065|Dietary Supplement|Enriched rice milk containing 7.32g Salvia hispanica|Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
16288559|NCT00728065|Dietary Supplement|Enriched rice milk containing 15.58g Salvia hispanica|Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
16288560|NCT00728065|Dietary Supplement|Enriched rice milk containing 24g Salvia hispanica|Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica
16288561|NCT00728052|Drug|GSK598809|GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
16288562|NCT00728052|Drug|Placebo|Placebo capsules will be administered orally with water.
16288563|NCT00728013|Drug|Atorvastatin|Eligible patients are randomly assigned (1:1 ratio) by center to intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins)
16288564|NCT00728013|Drug|Atorvastatin|Eligible patients are randomly assigned (1:1 ratio) by center to moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins).
16288565|NCT00728000|Drug|Gemcitabine|Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
16288566|NCT00728000|Drug|Oxaliplatin|100mg/m2 IV on days 1 and 15 given over 120 mins.
16288567|NCT00728000|Drug|Erlotinib|100mg/day PO on days 1-14 and 15-28
16288568|NCT00727987|Drug|CNTO 148|50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
16288569|NCT00727987|Drug|Placebo|Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
16288570|NCT00727987|Drug|Methotrexate (MTX)|6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
16288571|NCT00727961|Drug|Pegylated Liposomal Doxorubicin hydrochloride|Caelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
16288572|NCT00727948|Drug|Aspirin|325 mg tablets, once daily for 45 days
16288573|NCT00727935|Drug|Lidocaïne|
16288574|NCT00727935|Drug|Ropivacaïne|
16288575|NCT00727935|Drug|Placebo|
16288576|NCT00727922|Drug|Mangafodipir|Mangafodipir (0.5 ml/kg) is administered as a 30 minutes infusion just after each administration of oxaliplatin. The oxaliplatin dose (85 to 100 mg/m²) and the length of the infusion (2 hours) are the same that before the inclusion and modifications are not authorized during all the study participation. During 4 months (8 administrations).
16288577|NCT00727909|Device|Hearing Aid Treatments|"Hearing aid treatments:
~Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)"
16288707|NCT00726830|Drug|oxycodone hydrochloride|Given orally
16288708|NCT00726817|Drug|Butyrate|
16288578|NCT00727896|Behavioral|Pre-coded messages|Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder
16288579|NCT00727896|Drug|Diabetes Treatment|Life style modification and drug therapy
16288580|NCT00727870|Device|Shapes by PolyMem dressing|Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
16288581|NCT00727870|Device|Shapes by PolyMem Silver Dressing|Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
16288582|NCT00727870|Device|Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site|Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.
16288583|NCT00727857|Drug|Pioglitazone and metformin|Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
16288584|NCT00727857|Drug|Pioglitazone|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
16288585|NCT00727857|Drug|Metformin|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
16288586|NCT00727844|Drug|Immediate Start Linezolid|
16288587|NCT00727844|Drug|Delayed Start Linezolid|
16288588|NCT00727831|Drug|glucarpidase|
16288589|NCT00727831|Drug|leucovorin calcium|
16288590|NCT00727831|Drug|methotrexate|
16288591|NCT00727831|Other|laboratory biomarker analysis|
16288592|NCT00727831|Procedure|quality-of-life assessment|
16288593|NCT00727831|Radiation|radiation therapy|
16288594|NCT00727818|Device|guided bone regeneration|
16288595|NCT00727792|Procedure|MRI -Clinical|MRI done is standard of care
16288596|NCT00727792|Procedure|MRI-Research|MRI includes extra sequences
16288597|NCT00727779|Behavioral|strength training|eight weeks of progressively increasing resistance training will be done in both groups side-by-side
16288598|NCT00727766|Drug|Clofarabine|
16288599|NCT00727753|Drug|Ranibizumab|ranibizumab (0.5 mg) will be injected intraocular
16288600|NCT00727753|Drug|Bevacizumab|Bevacizumab (1.25 mg) will be injected intraocular
16288601|NCT00727753|Other|No treatment|No treatment
16288602|NCT00727740|Drug|Indomethacin|Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
16288603|NCT00727740|Drug|Placebo suspension|A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.
16288604|NCT00727727|Drug|Piribedil|
16288605|NCT00727701|Behavioral|Aftercare summary|A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.
16288606|NCT00727675|Behavioral|Integrated Cognitive Behavioral Therapy|CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
16288607|NCT00727662|Other|Iyengar Yoga|The poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention.
16288608|NCT00727662|Other|Wellness Seminar Series|The Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues.
16288609|NCT00727649|Drug|Psyllium powder|2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
16288610|NCT00727649|Drug|Loperamide|1 capsule daily for 28 days (weekly adjusted dose)
16288611|NCT00727636|Biological|Gardasil vaccine|standard 0.5 mL dose of Gardasil vaccine given at Day 0, Month 2, and Month 6
16288612|NCT00727597|Drug|Efavirenz 600mg|"QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
~The intervention may be switched for the following reasons:
~To resolve a Grade 3 or 4 Adverse Event
~The subject experienced a virologic failure (as defined in section 3.6.2)
~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"
16288613|NCT00727597|Drug|Boosted Lexiva|"Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
~The intervention may be switched for the following reasons:
~To resolve a Grade 3 or 4 Adverse Event
~The subject experienced a virologic failure (as defined in section 3.6.2)
~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"
16288614|NCT00727584|Radiation|radiation therapy|Patients undergo external beam radiotherapy
16288615|NCT00727571|Other|Observations|This is a non-interventional, observational study; no investigational product is being used
16288616|NCT00727558|Device|nelfilcon A|spherical soft contact lens
16288617|NCT00727558|Device|narafilcon A|spherical soft contact lens
16288618|NCT00727545|Other|iron bisglycine chelate|
16288619|NCT00727545|Other|placebo|
16288620|NCT00727532|Drug|Sorafenib|400mg by mouth twice daily for 28 consecutive days
16288621|NCT00727519|Dietary Supplement|Pomegranate juice|
16288622|NCT00727519|Dietary Supplement|Placebo|
16288623|NCT00727506|Drug|BIBW 2992|BIBW 2992 once daily
16288624|NCT00727506|Drug|TMZ|TMZ 21/28
16288625|NCT00727506|Drug|BIBW 2992 plus TMZ|BIBW 2992 once daily plus TMZ 21/28 days
16288626|NCT00727493|Drug|alendronate once weekly 70mg|alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
16288627|NCT00727493|Drug|placebo|placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
16288628|NCT00727480|Procedure|Ultrasound|Ultrasound scanning of fingertips for assessment of possible imaging modes with Gray scale ultrasound, color flow vascularity imaging, and color flow vascularity imaging before and after exercise.
16288629|NCT00727467|Device|Auditory Cueing Device|Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks.
16288630|NCT00727454|Device|CPAP|Continuous Positive Airway Pressure (CPAP) during sleep for 3 months.
16288631|NCT00727454|Device|No treatment|No treatment
16288632|NCT00727441|Biological|GVAX pancreatic cancer vaccine|Given intradermally
16288633|NCT00727441|Drug|cyclophosphamide|Given IV (Arm B), given orally (Arm C)
16288634|NCT00727428|Biological|FluLaval® TF|One IM injection.
16288635|NCT00727415|Drug|Cyclophosphamide|All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).
16288636|NCT00727415|Drug|Fludarabine phosphate|All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).
16288637|NCT00727415|Drug|Lenalidomide|"All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).
~In the first phase of the study, the dose of Lenalidomide given with FC will be gradually escalated to reach the MTD. In the second phase of the study, FC will be given in combination with the Lenalidomide escalated to the MTD or the maximum planned dose."
16288638|NCT00727389|Behavioral|Physiotherapy|Exercise two days a week for six month
16288639|NCT00727363|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri DSM 17938 will be administered at a dose of ten to the eighth colony-forming units in 5 drops of a commercially available oil suspension once per day until discharge from the hospital.
16288640|NCT00727363|Dietary Supplement|Placebo|5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.
16288641|NCT00727350|Radiation|Fractionated stereotactic body radiation therapy|For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.
16288642|NCT00727337|Behavioral|LACE-computer|Computerized Auditory Training
16288643|NCT00727337|Behavioral|PLACEBO-Directed listening|Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along
16288644|NCT00727337|Behavioral|CONTROL|No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids
16288645|NCT00727337|Behavioral|Lace-DVD|DVD based Auditory Training
16288646|NCT00727324|Drug|bovine intestinal alkaline phosphatase (BIAP)|30,000U/24h for 7 consecutive days via a duodenal catheter
16288647|NCT00727311|Biological|PegIntron (peginterferon alfa-2b; SCH 54031) injector|PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling
16288648|NCT00727311|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling
16288649|NCT00727298|Biological|Infliximab|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
16288650|NCT00727272|Drug|Quinine Sulfate Capsules 324 mg|One 324 mg capsule administered after an overnight fast of at least 10 hours.
16288651|NCT00727272|Drug|Quinine Sulphate Tablets 300 mg|One 300 mg tablet administered after an overnight fast of at least 10 hours.
16288652|NCT00727272|Drug|Quinine Sulfate Capsules 324 mg|One 324 mg capsule administered thirty minutes after the initiation of a standardized, high-fat breakfast.
16288653|NCT00727259|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b will be administered according to the products' labeling.
16288654|NCT00727259|Drug|Ribavirin (SCH 18908)|Ribavirin will be administered according to the products' labeling.
16288655|NCT00727246|Drug|CDP-Choline|1000 mg CDP-Choline 2 x per day for 6 weeks.
16288656|NCT00727246|Drug|Placebo|Treatment with placebo for 6 weeks
16288657|NCT00727233|Drug|Nexavar (BAY 43-9006) (Sorafenib)|
16288658|NCT00727233|Drug|Toxicity, Pharmacokinetics|
16288659|NCT00727233|Drug|Pharmacodynamics|
16288660|NCT00727233|Drug|Radiographic Evaluation|
16288661|NCT00727233|Drug|QOL assessment, Neuropsychological|
16288662|NCT00727233|Drug|Bony Toxicity|
16288663|NCT00727207|Drug|everolimus|
16288664|NCT00727194|Drug|eculizumab|eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses
16288665|NCT00727194|Drug|Placebo|Placebo IV weekly for 4 doses then every two weeks for 7 doses
16288666|NCT00727181|Device|Trifecta aortic heart valve|Replacement of a diseased, damaged, or malfunctioning aortic heart valve
16288667|NCT00727155|Behavioral|Adjusting to Chronic Conditions Using Education Support and Skills|This psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques.
16288668|NCT00727142|Procedure|Surgical treatment|Insertion of a functioning shunt
16288669|NCT00727129|Drug|Divigel|
16288709|NCT00726804|Drug|Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab)|Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow.
16288994|NCT00724347|Behavioral|Consonant Identification Training|Subjects received psychophysically adaptive, consonant identification training in consonant discrimination on PCs in their homes.
16288670|NCT00727116|Behavioral|PA Abusive Head Trauma Prevention Program: State-wide|Upon the birth of the child in a Pennsylvania hospital, all parents (mothers, and whenever possible, fathers or father figures) will be asked to read written materials and view an 8-minute video on the dangers of violent infant shaking. Parent education materials contain four key messages: crying is a normal infant behavior, how to keep calm when an infant is crying, how to help calm a crying infant, how to select other caregivers for your infant. Parents will be asked to voluntarily sign a commitment statement affirming their receipt and understanding of the materials.
16288671|NCT00727116|Behavioral|PA Abusive Head Trauma Prevention Program Booster: Central PA|All primary care providers serving families of newborns in half of the counties in Central PA will be asked to provide all parents of newborns at the 2-, 4-, and 6-month immunization visits another set of written materials about violent infant shaking and voluntarily sign a response form that they read and understood the materials.
16288674|NCT00727090|Drug|Conivaptan|Conivaptan 20 mg once, followed by conivaptan 20 mg over 24 hours
16288675|NCT00727077|Biological|IntronA (interferon alfa-2b; SCH 30500)|IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling
16288676|NCT00727077|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling
16288677|NCT00727064|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|
16288678|NCT00727064|Drug|Venlafaxine Extended Release (VEN ER)|
16288679|NCT00727038|Drug|Ranibizumab (Lucentis)|0.5 mg ranibizumab intravitreal injection single dose administration
16288680|NCT00727025|Device|wound closure device (Steri-Strip™)|wound closure with steri-strip S
16288681|NCT00727012|Device|mitral valve repair (SJM® Rigid Saddle Ring)|mitral valve repair due to mitral degenerative or functional disease
16288682|NCT00726999|Drug|Gabapentin|oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
16288683|NCT00726999|Drug|Placebo|
16288684|NCT00726999|Drug|Morphine|Administered as needed
16288685|NCT00726986|Drug|cisplatin|Cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16288686|NCT00726986|Drug|etoposide|Etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16288687|NCT00726986|Drug|sorafenib tosylate|Oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.
16288688|NCT00726973|Drug|Ranibizumab|Ranibizumab, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness >100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter.
16288689|NCT00726973|Drug|Ranibizumab monotherapy|3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as arm 1) At intervals of no less than 3 months from the previous sham PDT they will receive sham PDT if retreatment criteria are met.
16288690|NCT00726960|Drug|aprepitant|Oral, 125 mg once daily for one week
16288691|NCT00726960|Drug|Pseudo-placebo - buprenorphine|Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
16288692|NCT00726947|Procedure|Ultrasound|Ultrasound imaging of Acute DVT
16288693|NCT00726947|Procedure|Ultrasound|Ultrasound imaging of Chronic DVT
16288694|NCT00726934|Other|Food Safety Guidelines|Participants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food.
16288695|NCT00726934|Other|Neutropenic Diet|"The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations:
~Avoid raw vegetables and fruit (Oranges and bananas are okay.)
~Avoid take-out foods and fast foods and fountain drinks.
~Avoid aged cheese (blue, Roquefort, Brie).
~Cook all produce to well done. Eggs must be hard-boiled.
~Avoid deli meats.
~No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store.
~No well water
~No yogurt"
16288696|NCT00726908|Dietary Supplement|Low carbohydrate|43% CHO
16288697|NCT00726895|Drug|Quinine Sulfate Capsules 324 mg|1 x 324 mg capsule
16288698|NCT00726895|Drug|Quinine Sulfate Capsules 324 mg|2 x 324 mg capsules
16288699|NCT00726882|Procedure|Blood sample collection only|Approximately monthly collection of blood samples.
16288700|NCT00726882|Drug|ABT-333|Previous treatment in prior ABT-333 studies.
16288701|NCT00726869|Drug|Elotuzumab (HuLuc63)|Cohort 1 - 2.5 mg/kg elotuzumab IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 2 - 5.0 mg/kg elotuzumab IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 3 - 10.0 mg/kg elotuzumab IV withbortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; and Cohort 4 - 20.0 mg/kg elotuzumab IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8.
16288702|NCT00726856|Drug|Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate|Ezetimibe 10 mg taken daily for 3 months
16288703|NCT00726843|Other|8 weeks of Iyengar Yoga|Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)
16288704|NCT00726843|Other|8 weeks of Iyengar Yoga|Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions
16288705|NCT00726830|Drug|methadone hydrochloride|Given orally
16288706|NCT00726830|Drug|morphine sulfate|Given orally
16288710|NCT00726791|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|Patients receive high frequency rTMS applied to the motor cortex (M1 area). The treatment protocol consists of 10 sessions of rTMS. At each session, patients receive 30 stimulation trains (10 Hz, 4 sec, 100% motor threshold) with 26 sec inter-train interval, resulting in a total of 1200 pulses per session.
16288711|NCT00726752|Drug|Axitinib (AG-013736)|Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.
16288712|NCT00726739|Biological|aldesleukin|IL-2 Alone - administer 10 x 10^6 International Units subcutaneously (SQ) will be given on day 1 and day 2 every 4 weeks until disease progression or for a maximum of 12 treatment cycles.
16288713|NCT00726739|Biological|allogeneic large multivalent immunogen vaccine|Allogeneic tumor cell membrane-coated large multivalent immunogen (LMI [1 x 10^7, 5-μm silica spheres]) will be given as an intradermal injection every 4 weeks for up to 12 injections. Each vaccine dose will be 0.2 ml.
16288714|NCT00726726|Drug|Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)|Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day
16288715|NCT00726726|Drug|BMS-708163|Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days
16288716|NCT00726726|Drug|BMS-708163 + Cooperstown Cocktail|Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days
16288717|NCT00726713|Other|Metanx (a medical food)|Metanx one tablet twice a day
16288718|NCT00726713|Other|Metanx placebo|Metanx placebo one tablet twice a day
16288719|NCT00726700|Biological|pegfilgrastim|Given subcutaneously
16288720|NCT00726700|Biological|rituximab|Given IV
16288721|NCT00726700|Drug|cyclophosphamide|Given IV
16288722|NCT00726700|Drug|doxorubicin hydrochloride|Given IV
16288723|NCT00726700|Drug|prednisone|Given orally
16288724|NCT00726700|Drug|vincristine sulfate|Given IV
16288725|NCT00726687|Drug|indibulin|indibulin, dose escalation, 400-600 mg taken twice every day
16288726|NCT00726687|Drug|capecitabine|capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle
16288727|NCT00726648|Drug|CDP323|50mg capsules, 100mg bid for 4 weeks
16288728|NCT00726648|Drug|CDP323|250mg capsules, 500mg bid for 4 weeks
16288729|NCT00726648|Drug|CDP323|250mg capsules, 1000mg bid for 4 weeks
16288730|NCT00726648|Drug|CDP323|250mg capsules, 1000mg daily for 4 weeks
16288731|NCT00726648|Drug|Placebo|placebo capsules for 4 weeks
16288732|NCT00726635|Behavioral|Cognitive intervention|The intervention will last one hour and will include cognitive technique (self-talk). The technique will be demonstrated to the woman, practiced with her, and taped so as to encourage further practice at home.
16288733|NCT00726635|Other|Control group|A one hour conversation with a nurse
16288734|NCT00726635|Other|psycho-physiological intervention|The intervention will last an hour and will include a psycho-physiological intervention (relaxation and guided imagery). The technique will be demonstrated to the woman, practiced with her, and taped so as to assure further practice at home
16288735|NCT00726622|Procedure|Open laparotomy and rectal resection|Patients undergo open laparotomy and rectal resection.
16288736|NCT00726622|Procedure|Laparoscopic-assisted rectal resection|Patients undergo laparoscopic-assisted rectal resection.
16288737|NCT00726609|Drug|Posaconazole|The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily.
16288738|NCT00726596|Drug|hydroxychloroquine|Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients (cohort A). Once cohort A completed, the dose of hydroxychloroquine will then be increased to 600mg per day (200mg three times per day)(cohort B).
16288739|NCT00726583|Drug|PX-866|Oral solution, dose escalation, once per day on days 1 to 5 and 8 to 12 or days 1-28 of a 28 day cycle, until progression or development of unacceptable toxicity
16288740|NCT00726570|Device|Sequential compression device therapy|"Pneumatic stockings will be applied to patients.
~Pressures ranging from 12 to 40 mmHg will be applied at different levels of the lower limb for 40-second cycles at 2-minute intervals. Therapy will continue until the morning after surgery."
16288741|NCT00726570|Drug|Dalteparin|"2500 UI qd if ≤ 50 kg body weight
~5000 UI qd if > 50 kg"
16288742|NCT00726570|Procedure|TEG|"A 2-ml blood sample will be used for each exam. A full analysis will be run both with and without heparinase at each time point.
~TEG analyses will be run at:
~Patient admission (before SCD start)
~40-60 min after admission
~Morning after surgery"
16288743|NCT00726557|Biological|PegIntron (pegylated interferon alfa-2b; SCH 54031)|PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
16288744|NCT00726557|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
16288745|NCT00726544|Drug|ARC 1779 Placebo|ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper.
16288746|NCT00726544|Drug|ARC1779 Injection|ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 3μg/mL.
16288907|NCT00725023|Device|TDP© Lamp|TDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals
16288908|NCT00725023|Device|Dummy TDP© Lamp|The dummy TDP© heat lamp is an electrical device with the heating element removed.
16288747|NCT00726544|Drug|ARC1779 Injection|ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 6μg/mL.
16288748|NCT00726544|Drug|ARC1779 Injection|ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 12μg/mL.
16288749|NCT00726531|Behavioral|Otago Exercise Programme|Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require
16288750|NCT00726531|Behavioral|Fame|Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.
16288751|NCT00726531|Other|Treatment As Usual|Treatment as usual by the general practitioner
16288752|NCT00726505|Drug|Dapagliflozin|Tablets, Oral, Once Daily, up to 29 days:
16288753|NCT00726492|Other|Continuous short wave diathermy (CSWD)|CSWD applied twice a week for 4 weeks
16288754|NCT00726492|Other|Hydrotherapy|Hydrotherapy (exercise in water) attended twice a week for 4 weeks
16288755|NCT00726479|Drug|BIBW 2948 BS|7.5 mg b.i.d, 15mg q.d, 15mg b.i.d
16288756|NCT00726466|Drug|Efalizumab, Ranibizumab|
16288757|NCT00726453|Device|Resolute Zotarolimus-Eluting Coronary Stent|Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
16288758|NCT00726440|Device|Navigator®|Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data
16288759|NCT00726440|Device|Navigator®|Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months.
16288760|NCT00726440|Device|Placebo|Patients will have their usual follow up with self-monitoring blood glucose
16288761|NCT00726427|Drug|AZD1656|Dose escalation to achieve maximum tolerated dose
16288762|NCT00726427|Drug|AZD1656|Oral single dose
16288763|NCT00726414|Drug|Quinine Sulfate 2 x 324 mg Capsules|Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours.
16288764|NCT00726414|Drug|Quinine Sulfate 2 x 324 mg Capsules|Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
16288765|NCT00726401|Drug|COLD-fX|200mg BID for 4 weeks
16288766|NCT00726401|Drug|Placebo|200mg BID for 4 weeks
16288767|NCT00726388|Drug|DIC075V (intravenous diclofenac sodium)|multiple doses up to 5 days
16288768|NCT00726375|Drug|Etanercept (Enbrel)|Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections.
16288769|NCT00726349|Other|No intervention|Observational study.
16288770|NCT00726336|Drug|GSK1349572 and tenofovir|
16288771|NCT00726323|Drug|foretinib (formerly GSK1363089 or XL880)|treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule
16288772|NCT00726310|Device|SpineLink® , SpineLink® II|Spine plate system for lumbar spinal fusions
16288773|NCT00726271|Dietary Supplement|light olive oil, fish oil capsules, flax seed oil capsules|fish oil 1000 mg capsules three daily flax seed oil 1000 mg capsules three daily light olive oil 30 ml to 60 ml daily(weight less than 160 pounds, 30 ml/ weight 160-200 pounds 45 ml/ weight over 200 pounds 60 ml)
16288774|NCT00726258|Drug|ketamine|ketamine with various concentrations
16288775|NCT00726258|Drug|placebo|physiological serum
16288776|NCT00726245|Biological|PRGF|3-6mg IM (to area of muscle tear)
16288777|NCT00726245|Biological|Placebo|3cc IM of physiological saline
16288778|NCT00726232|Drug|Ruxolitinib|Ruxolitinib was administered orally and supplied as 5 mg and 25 mg tablets.
16288779|NCT00726219|Other|Femoral perineural catheter|Comparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery.
16288780|NCT00726206|Other|Electroencephalogram, recording the movements|Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging
16288781|NCT00726193|Device|OsteoGen|OsteoGen Implatable stimulator
16288782|NCT00726180|Drug|trastuzumab (Herceptin®)|About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
16288783|NCT00726167|Device|Procalcitonin Level|Procalcitonin concentrations will be determined every day and will be compared with the clinical diagnosis based upon standard clinical practice. All subjects enrolled will be followed until the patient is either extubated or discharged from the SICU.
16288957|NCT00724659|Procedure|Ultrasound|Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)
16289566|NCT00720343|Drug|Choline|Oral Choline 20 grams before surgery
16288784|NCT00726154|Behavioral|IPSRT|Interpersonal and social rhythm therapy (IPSRT) focuses specifically on rhythmicity. IPSRT is based on the social zeitgeber hypothesis (Ehlers et al., 1988; 1993) and the conviction that regularity of social routines and stability of interpersonal relationships have a protective effect in recurrent mood disorders. In IPSRT, resolution of depressive symptoms is theorized to come about through the exploration of the links among mood symptoms, stability of social rhythms and quality of social relationships and social role performance, and the identification and management of potential precipitants of rhythm disruption.
16288785|NCT00726154|Behavioral|Collaborative Care|The collaborative care (CC) condition is a less intensive psychosocial intervention that was employed as the control condition in the STEP-BD study of psychosocial treatment (see Miklowitz et al., 2007). Participants assigned to this condition will receive a psychoeducational videotape and a workbook including information about: 1) the diagnosis, management, and treatment of bipolar illness; 2) the importance of medication adherence; 3) schedule management including daily mood charting; 4) typical biases in thinking relevant to mood states; 5) improving relationships through communication skills; and 6) developing a treatment contract geared toward preventing episodes.
16288786|NCT00726141|Behavioral|Brief intervention, Motivational Interviewing, Expert System|Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter
16288787|NCT00726128|Device|VueLock™ Anterior Cervical Plate|Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)
16288788|NCT00726115|Drug|SAM-531|
16288789|NCT00726115|Drug|placebo|
16288790|NCT00726102|Other|Meat|2 0z of locally available meat per day
16288791|NCT00726102|Other|Cereal|Daily provision of cereal to infants from 6-18 mos
16288792|NCT00726102|Other|fortified rice cereal|Daily provision of fortified cereal to infants 6-18 months of age
16288793|NCT00726076|Behavioral|WebEase|"Computer-based epilepsy self-management program
~The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment"
16288794|NCT00726076|Behavioral|WebEase|Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
16288795|NCT00726063|Device|Nanotite dental implant|Nanotite root form titanium dental implant
16288796|NCT00726063|Device|Osseotite dental implant|Osseotite Root form titanium dental implant
16288797|NCT00726037|Drug|Ontak|One dose of Ontak 9 mcg/Kg IV over 30 minutes times 3 doses. 1 dose every other day
16288798|NCT00726011|Biological|Tetrodotoxin|30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response
16288799|NCT00725985|Drug|Cladribine|Cladribine tablets were administered until CDMS conversion, whichever occur first.
16288800|NCT00725985|Drug|Placebo|Placebo matched to cladribine tablets were administered.
16288801|NCT00725985|Drug|Rebif® new formulation (RNF)|Participants who converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received RNF subcutaneously at a dose of 44 microgram (mcg) three times a week. Participants who converted to CDMS during long-term follow-up (LTFU) period, received RNF subcutaneously at a dose of 44 mcg three times a week.
16288802|NCT00725972|Other|Augment O2 Delivery by hemodynamic protocol|Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management.
16288803|NCT00725972|Procedure|High Risk Surgery|Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care
16288804|NCT00725959|Behavioral|Online social networking HIV prevention|messages about HIV posted in online social networking sites
16288805|NCT00725946|Drug|Iodine-124|
16288806|NCT00725946|Radiation|PET/CT with Iodine-124|
16288807|NCT00725933|Drug|BIIB028|IV infusion administered twice weekly until disease progression or unacceptable toxicity
16288808|NCT00725920|Drug|Topiramate|patients will receive the active drug. The starting dose was 25 mg/day, with weekly increments of 25 mg/day, according to clinical status. The maximum dose considered was 200 mg/day
16288809|NCT00725920|Drug|placebo control group|initial dose 25 mg day, increments of 25 mg each 2 weeks. Up to 100 mg/day Those with no intolerance and no response dose could be up to 200 mg day
16288810|NCT00725907|Biological|PGRF|injection of 6cc into injured area
16288811|NCT00725907|Biological|placebo saline|injection of 6cc into injured area
16288812|NCT00725894|Device|Pediatric Locking Nail|The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
16288813|NCT00725881|Drug|Trans sodium crocetinate (TSC)|Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
16288814|NCT00725881|Drug|0.9% normal saline|A total volume of 5.0 mL normal saline will be dosed in a superficial vein of the arm via syringe over a period of up to 2 minutes.
16288815|NCT00725868|Other|Data private hospitals, angioplasty, sampling of blood|"Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency
~coronary angioplasty
~Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made"
16288816|NCT00725855|Drug|MEM 3454|1 mg dose
16288817|NCT00725855|Drug|MEM 3454|5 mg dose
16288818|NCT00725855|Drug|MEM 3454|15 mg dose
16288819|NCT00725855|Drug|MEM 3454|50 mg dose
16288820|NCT00725855|Drug|Placebo for MEM 3454|Placebo dose
16288821|NCT00725842|Biological|Peg-IFN alfa-2b|Peg-IFN alfa-2b administered in accordance with approved labeling
16288822|NCT00725842|Drug|Ribavirin|Ribavirin administered in accordance with approved labeling
16288823|NCT00725829|Drug|simvastatin|Simvastatin 40mg/d
16288824|NCT00725829|Drug|ezetimibe|ezetimibe 10mg/d
16288825|NCT00725829|Drug|placebo|placebo
16288826|NCT00725803|Drug|GS-9450|GS-9450 capsules administered orally once daily
16288827|NCT00725803|Drug|GS-9450 Placebo|Placebo to match GS-9450 administered orally once daily
16288993|NCT00724360|Drug|Herceptin (trastuzumab)|Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression
16288828|NCT00725790|Drug|Vardenafil|"10 mg vardenafil on demand treatment for first 4 weeks.
~A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period.
~A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period."
16288829|NCT00725790|Drug|Placebo|"10 mg placebo on demand treatment for first 4 weeks.
~A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period.
~A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period."
16288830|NCT00725777|Drug|artemether-lumefantrine|Standard artemether-lumefantrine treatment
16288831|NCT00725764|Drug|GSK1363089 (foretinib)|Multitargeted tyrosine kinase inhibitor
16288832|NCT00725751|Biological|Pegylated interferon alfa-2b (PegIFN-2b)|PegIFN-2b administered according to European labeling.
16288833|NCT00725751|Drug|Ribavirin|Ribavirin administered according to European labeling.
16288834|NCT00725738|Genetic|Stem Cell Transplantation|"1-2 million of CD34 cells injected through the infarct related artery by PTCA over-the-wire catheter during multiple sequences of balloon artery occlusion with a mean duration of 30 minutes."
16288835|NCT00725725|Behavioral|Cognitive-behavioral therapy|Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration).
16288836|NCT00725725|Drug|Org 25935|4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.
16288837|NCT00725725|Drug|Org 25935|12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period.
16288838|NCT00725725|Drug|Placebo|Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.
16288839|NCT00725712|Drug|GSK1363089 (formerly XL880)|c-MET tyrosine kinase inhibitor
16288840|NCT00725686|Drug|PF-04523655|This is a dose-escalation study (50, 100, 200, 400, 670, 1000, 1500, 2250, 3000 microgram) given at baseline and then the subject is followed up for 24 months
16288841|NCT00725634|Biological|AV-299|AV-299 monotherapy will be given as intravenous infusion in dose-escalation cohorts at 2, 5, 10, and 20 mg/kg. Once the RP2D has been determined the cohort may be expanded to include up to 12 patients for safety assessment and enriched with up to 12 additional Multiple Myeloma patients.
16288842|NCT00725634|Biological|AV-299 + erlotinib|AV-299 will be given as intravenous infusion at RP2D in combination with erlotinib (150 mg daily). Once the combination-RP2D has been determined the cohort may be expanded to include up to 12 additional patients.
16288843|NCT00725621|Biological|Infliximab|Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.
16288844|NCT00725608|Drug|buprenorphine/naloxone|2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months
16288845|NCT00725582|Drug|IMA-026|
16288846|NCT00725582|Other|Placebo|
16288847|NCT00725569|Drug|Bellis perennis and Staphysagria (C6)|homeopathic remedy
16288848|NCT00725569|Drug|Bellis perennis and Staphysagria (C30)|Homeopathic Remedy
16288849|NCT00725569|Drug|Placebo|Placebo remedy, identical in size, shape and taste to treatment remedies
16288850|NCT00725556|Other|Speech Therapy|Speech Therapy
16288851|NCT00725543|Biological|Infliximab|Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians.
16288852|NCT00725530|Device|balafilcon A contact lens (PureVision)|Commercially marketed, silicone hydrogel contact lens
16288853|NCT00725530|Device|etafilcon A contact lens (Acuvue2)|Commercially marketed, hydrogel contact lens
16288854|NCT00725517|Drug|Icodextrin|Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks.
16288855|NCT00725504|Drug|Intravenous lidocaine|Intravenous lidocaine administered up to 5 µg/ml.
16288856|NCT00725491|Drug|ganirelix|On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.
16288857|NCT00725491|Drug|triptorelin|a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 <= 50 pg/ml (<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.
16288858|NCT00725478|Drug|Piribedil|
16288859|NCT00725452|Biological|Infliximab|Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.
16288860|NCT00725439|Drug|Talarozole|Oral Dose 1.0 mg once daily
16288861|NCT00725426|Drug|Bosutinib|
16288862|NCT00725413|Drug|etonogestrel implant (Implanon)|subdermal etonogestrel implant
16288863|NCT00725400|Other|Cetuximab and Radiation Therapy|Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
16288995|NCT00724334|Drug|SAR302503 (TG101348)|orally administered, once a day
16288864|NCT00725400|Procedure|Surgery and Radiation Therapy|Patients will undergo Surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
16288865|NCT00725374|Drug|tibolone|one tablet of 2.5 mg tibolone, per day, every day, for 14 ± 2 days (until the day before surgery).
16288866|NCT00725374|Drug|placebo|Subjects were to take one tablet of tibolone-matched placebo, per day, every day, for 14 ± 2 days (until the day before surgery).
16288867|NCT00725361|Drug|Ambrisentan|
16288868|NCT00725348|Drug|Talarozole|1.0 mg oral dose per day
16288869|NCT00725335|Procedure|curative resection without Pringle|Radical excision of liver cancer without the procedure of pringle manoeuvre
16288870|NCT00725335|Procedure|curative resection with Pringle manoeuvre|curative resection liver cancer under pringle manoeuvre
16288871|NCT00725322|Drug|Botulinum Toxin A|Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
16288872|NCT00725322|Drug|Placebo - Saline|Subcutaneous Saline injection given at site of scar neuroma
16288873|NCT00725296|Biological|Remicade (Infliximab)|Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians.
16288874|NCT00725283|Biological|GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI)|Intramuscular administration
16288875|NCT00725270|Drug|Mifepristone|600 mg of mifepristone
16288876|NCT00725270|Drug|Placebo Oral Tablet|Placebo comparator
16288877|NCT00725257|Other|Mediterranean diet|The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.
16288878|NCT00725257|Other|Low-fat diet|The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.
16288879|NCT00725244|Device|Bipolar eletrocoagulation|Bipolar Eletrocoagulation was performed with a high-frequency electrosurgical generator (ERBE® ICC 200 Eletromedizin, Tubingen, Germany), using Gold probe (Wilson- Cook®) with 7 Fr diameter and 300 cm length. The power setting was 50 W. Coagulation of each telangiectasia was achieved with the probes by applying light pressure directly on the telangiectasia.
16288880|NCT00725244|Device|Argon Plasma Coagulation|"Argon plasma coagulation was delivered using a spray-painting technique, with short applications at 40 W power with a gas flow of 1.0l per minute. APC equipment was an argon delivery unit (ERBE® ICC 300) coupled a high frequency surgery unit (ERBE® ICC 200). Only the end-firing probe with 2.3 mm and 220 cm length was used. The probe was purged with argon, tested and passed though the endoscope until it extends approximately 1 cm from the tip. The probe was hold just above the mucosal surface and the contact was avoided. During the procedure periodic suction was made to prevent over-distention with gas and consequently patient discomfort."
16288881|NCT00725231|Biological|alemtuzumab|Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
16288882|NCT00725231|Drug|chemotherapy|dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
16288883|NCT00725218|Drug|Saline|Saline 5 ml injection 10 min prior to propofol administration.
16288884|NCT00725218|Drug|Flurbiprofen Axetil|Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
16288885|NCT00725205|Biological|PegIntron (Peginterferon alfa-2b)|Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms [mcg]/killogram [kg]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
16288886|NCT00725205|Drug|Rebetol (Ribavirin)|Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
16288887|NCT00725192|Behavioral|Cognitive Processing Therapy|Clients will receive between 12 sessions of Cognitive Processing Therapy.
16288888|NCT00725192|Behavioral|Hypnosis|PArticipants will receive 3 sessions of hypnosis to specifically target sleep impairment.
16288889|NCT00725166|Other|Skeletal muscle aging|"W1 - Blood test
~Maximal voluntary contraction of quadriceps
~Hydrostatic weighing
~W2 - Maximal metabolic test using a cycloergometer
~W3 - Muscular biopsy"
16288890|NCT00725153|Device|Balafilcon A contact lenses (PureVision)|Commercially marketed, soft contact lenses worn bilaterally for 10 hours
16288891|NCT00725153|Device|Etafilcon A contact lenses (Acuvue2)|Commercially marketed, soft contact lenses worn bilaterally for 10 hours
16288892|NCT00725127|Drug|aspirin|100 mg/day upon awakening for five years
16288893|NCT00725127|Drug|aspirin|100 mg/day at bedtime for five years
16288894|NCT00725114|Biological|Tetrodotoxin|30 µg twice daily for 4 days
16288895|NCT00725114|Biological|Placebo|2 mL subcutaneous injection twice daily for 4 days
16288896|NCT00725101|Drug|Treatment for Fibromyalgia|FM participants starting any new pharmacologic FM agent.
16288897|NCT00725088|Behavioral|Exercise training|Exercise training
16288898|NCT00725075|Drug|MK-8435 (Org 25935) 4-8 mg|Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day
16288899|NCT00725075|Drug|Placebo|Matching placebo for MK-8435 (Org 25935) administered orally BID
16288900|NCT00725075|Drug|MK-8435 (Org 25935) 12-16 mg|Administered orally BID for a final concentration of 24-32 mg/day
16288901|NCT00725062|Biological|CD4+CD25+ regulatory T cells|Cohort 1 will receive 3 x 10^6 CD4+CD25+ cells/kg, Cohort 2 will receive 1 x 10^7 CD4+CD25+ cells/kg, Cohort 3 will receive 3 x 10^7 CD4+CD25 cells/kg
16288902|NCT00725062|Procedure|allogeneic hematopoietic stem cell transplantation|Occurs on Day 0 of study - HLA-identical sibling donor peripheral blood progenitor cell (PBPC) transplantation
16288903|NCT00725049|Device|Dental Implant (Nanotite)|Root form titanium dental implant
16288904|NCT00725036|Drug|inhaled human insulin|
16288905|NCT00725036|Drug|insulin aspart|
16288906|NCT00725036|Drug|insulin NPH|
16288909|NCT00725010|Drug|Temozolomide|Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
16288910|NCT00725010|Radiation|Radiotherapy|Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
16288911|NCT00724997|Biological|GHB01L1|Study medication administered as a single intranasal aerosol (520ul) at doses of 6.4 log10, 6.7 log10, 7.0 log10, 7.4 log10 and 7.7 log10 TCID50/volunteer
16288912|NCT00724984|Drug|PCI-24781|"Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart (BID), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).
~Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I."
16288913|NCT00724971|Drug|Inotuzumab Ozogamicin (CMC-544)|1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
16288914|NCT00724971|Drug|Rituximab (Rituxan)|375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
16288915|NCT00724958|Biological|Infliximab|Not specified in the protocol.
16288916|NCT00724945|Device|balafilcon A|multifocal contact lens
16288917|NCT00724945|Device|senofilcon A|multifocal contact lens
16288918|NCT00724932|Drug|Rocuronium|Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given.
16288919|NCT00724932|Drug|Sugammadex|After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC.
16288920|NCT00724932|Drug|Neostigmine|After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
16288921|NCT00724932|Drug|Atropine|After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
16288922|NCT00724906|Drug|123 I - ALTROPANE®|8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
16288923|NCT00724893|Biological|PegIFN-2b|PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
16288924|NCT00724893|Drug|Ribavirin|Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
16288925|NCT00724880|Drug|Clopidogrel|Clopidogrel is stopped 5 days prior to surgery
16288926|NCT00724880|Drug|Clopidogrel|Clopidogrel is stopped 3 days prior to surgery
16288927|NCT00724880|Drug|Clopidogrel|Clopidogrel is stopped 0 days prior to surgery
16288928|NCT00724867|Biological|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV over one hour every 28 days
16288929|NCT00724867|Biological|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV over one hour every 28 days
16288930|NCT00724854|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron administered in accordance with approved labeling
16288931|NCT00724854|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered in accordance with approved labeling
16288932|NCT00724841|Drug|Obatoclax Mesylate|Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
16288933|NCT00724841|Drug|Temozolomide|
16288934|NCT00724815|Drug|NP101 - Sumatriptan iontophoretic transdermal patch|Sumatriptan iontophoretic transdermal patch
16288935|NCT00724815|Drug|Placebo|NP101 Placebo iontophoretic transdermal patch
16288936|NCT00724802|Dietary Supplement|GTA (Glyceryl triacetate)|0.5 gr/kg x2/day syrup two times a day with increasing dose each 3 days till max 5gr /kg each day for 6 months
16288937|NCT00724802|Drug|GTA glyceryl triacetate|0.5 gr/kg twice a day with increase of 0.5 gr/kg every 3 days up to 5 gr/kg
16288938|NCT00724789|Drug|ganirelix|Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy
16288939|NCT00724789|Drug|GnRH agonist|Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy
16288940|NCT00724776|Biological|Albinterferon alfa 2b|recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
16288941|NCT00724763|Device|acupuncture|to Liv 3 and PE 9.
16288942|NCT00724763|Device|sham needle treatment|needle not in meridian area
16288943|NCT00724750|Device|Gauze suction (G-SUC)|Negative pressure wound therapy
16288944|NCT00724750|Device|Vacuum Assisted Closure Device (VAC)|Negative Pressure Wound Therapy
16288945|NCT00724737|Procedure|Presurgical MRI|"People who are scheduled to have brain surgery with undergo a fMRI of the brain before surgery. This is a functional scan, meaning that subjects will be asked to perform tasks (such as finger tapping or picture identification) during the MRI scan."
16288946|NCT00724737|Procedure|functional MRI (fMRI) of the brain|"Healthy subjects will be undergo a brain fMRI of the brain. fMRI is a functional scan, meaning that subjects will be asked to perform tasks (such as finger tapping or picture identification) during the MRI scan."
16288947|NCT00724724|Drug|Butylphthalide Soft Capsules|Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
16288948|NCT00724724|Drug|Aspirin|Aspirin 100mg Qd for 1 year
16288949|NCT00724711|Drug|emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)|FTC 200 mg/TDF 300 mg tablet, once a day
16288950|NCT00724711|Drug|abacavir (ABC)/lamivudine (3TC)|ABC 600 mg/3TC 300 mg tablet, once a day
16288951|NCT00724698|Drug|Desloratadine|Desloratadine 5 mg once daily
16288952|NCT00724685|Drug|Naropeine (Ropivacaine)|
16288953|NCT00724685|Drug|Placebo|saline
16288954|NCT00724672|Drug|etanercept|etanercept 50 mg subcutaneously once weekly
16288955|NCT00724672|Drug|infliximab|infliximab 3 mg/kg IV at Weeks 0, 2, and 6
16288956|NCT00724672|Drug|adalimumab|adalimumab 40 mg subcutaneously biweekly
16288958|NCT00724659|Procedure|Ultrasound|Ultrasound of the joint(s) after a clinically scheduled arthrogram is performed. Ultrasound images will then be compared to the arthrogram findings, other imaging findings such as MRI and surgical pathological findings such as arthroscopy (if any.)
16288959|NCT00724646|Other|Survey|3 individual surveys
16288960|NCT00724646|Other|Focus group|Focus group discussions facilitated by a psychologist
16288961|NCT00724633|Other|Lowering the dialysate sodium|Please see above
16288962|NCT00724620|Biological|Peginterferon alfa-2b (SCH 054031)|All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
16288963|NCT00724620|Drug|Ribavirin (SCH 018908)|All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
16288964|NCT00724594|Drug|N-acetylcysteine|NAC (100 mg/kg/dose) was given intravenously to mothers within 4 hours of diagnosis of chorioamnionitis, and every 6 hours until delivery. NAC was given to preterm (12.5 mg/kg/dose) and term infants (25 mg/kg/dose) every 12 hours for 5 doses after birth.
16288965|NCT00724594|Drug|Control|Saline was given in the same volume, at the same timing as NAC infusions
16288966|NCT00724581|Drug|Amiodarone|intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days
16288967|NCT00724568|Drug|Lenalidomide|Patients will be treated with Revlimid on days 1-14 in 3-week cycles for 4-8 cycles.
16288968|NCT00724568|Drug|Bortezomib|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11
16288969|NCT00724568|Drug|Dexamethasone|Patients will be treated with Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels.
16288970|NCT00724568|Drug|Doxil|Patients will be treated with Doxil on day 4.
16288971|NCT00724542|Drug|Voglibose tablets|0.2mg Tid
16288972|NCT00724529|Biological|Infliximab|Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.
16288973|NCT00724516|Device|Novel Breast Compression Paddle|Instead of using the regular wire localization mammography compression paddle, a new breast compression paddle will be used. The new breast compression paddle is similar to a tennis racquet. It consists of crossing plastic strings that are strung tightly in a frame. The needle/wire can be inserted anywhere between the strings.
16288974|NCT00724503|Device|SIR-Spheres yttrium-90 microspheres|"SIR-Spheres microspheres (yttrium-90 [Y-90] labelled resin microspheres), hepatic artery injection administered on Day 3 or 4 of cycle 1.
~mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.
~Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.
~In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2."
16288975|NCT00724503|Drug|Systemic chemotherapy (FOLFOX)|"mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.
~Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.
~In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2."
16288976|NCT00724490|Procedure|Deep Brain Stimulation|Unilateral Deep Brain Stimulation in the right Nucleus Accumbens
16288977|NCT00724477|Drug|INEGY|Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks
16288978|NCT00724464|Biological|PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)|Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 μg/kg/week subcutaneously in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
16288979|NCT00724464|Drug|Rebetol (ribavirin)|Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
16288980|NCT00724451|Biological|Peginterferon alfa-2b|Peginterferon alfa-2b administered in accordance with approved labeling
16288981|NCT00724451|Drug|Ribavirin|Ribavirin administered in accordance with approved labeling
16288982|NCT00724451|Biological|Peginterferon alfa-2a|Peginterferon alfa-2a administered in accordance with approved labeling
16288983|NCT00724425|Drug|IPI-493|Capsules, Multiple Schedules
16288984|NCT00724412|Other|Systane|Dry Eye relief eye drops
16288985|NCT00724412|Other|Optive|Dry Eye relief eye drops
16288986|NCT00724399|Behavioral|Survey on womens health Issues.|Cardiovascular health.
16288987|NCT00724386|Drug|Paclitaxel|1-hour IV infusion once weekly for 12 to 14 weeks
16288988|NCT00724386|Drug|Vinorelbine|escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
16288989|NCT00724386|Drug|Filgrastim|"daily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12).
~For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject"
16288990|NCT00724386|Radiation|Radiation|Radiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy
16288991|NCT00724373|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
16288992|NCT00724373|Drug|Ribavirin (SCH 18908)|Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
16289151|NCT00723255|Biological|bevacizumab|Given IV
16289152|NCT00723255|Drug|temsirolimus|Given IV
16288996|NCT00724321|Drug|iloprost|A dose of inhaled iloprost (or placebo) will be given once at baseline and then at altitude. Measurements will be obtained before and after inhalation. Patients will then cross over and be given a dose of placebo (or iloprost)and measurements will be repeated.
16288997|NCT00724308|Other|Telephone Care Coordination|The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
16288998|NCT00724308|Other|Telephone Care Coordination with state Quitline|"The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state Quitline; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
16288999|NCT00724295|Drug|peginterferon alfa-2b|PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.
16289000|NCT00724295|Drug|ribavirin|Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.
16289001|NCT00724282|Drug|Eszopiclone|Eszopiclone 3 mg by mouth daily at bedtime for 9 days
16289002|NCT00724282|Drug|Placebo|Placebo by mouth daily at bedtime for 9 days
16289003|NCT00724269|Device|OPTI-FREE RepleniSH|Multi-Purpose Solution for soft contact lenses
16289004|NCT00724269|Device|ReNu MultiPlus MPS|Multi-Purpose Solution for soft contact lenses
16289005|NCT00724256|Drug|ceftibuten|ceftibuten 9mg/kg once a day for 7 days.
16289006|NCT00724256|Drug|ceftibuten|ceftibuten 9mg/kg once a day for 10 days.
16289007|NCT00724243|Drug|Infliximab|Infliximab given in accordance with the local summary of product characteristics
16289008|NCT00724230|Drug|PegIntron (peginterferon alfa-2b; SCH 54031)|"PegIntron administered in accordance with approved labeling
~Subcutaneous injection once weekly for 24 weeks."
16289009|NCT00724230|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
16289010|NCT00724217|Other|Standard Process 21 Day Purification Program (SPPP)|The Standard Process 21 Day Purification Program (SPPP) consists of a controlled food intake regimen of mostly fruit and vegetables with restricted calories, protein and fats plus daily use of herbal and whole food based supplements.
16289011|NCT00724217|Other|Standard Process 21 Day Purification Program (SPPP)|The Standard Process 21 Day Purification Program (SPPP) consists of a controlled food intake regimen of mostly fruit and vegetables with restricted calories, protein and fats plus daily use of herbal and whole food based
16289012|NCT00724204|Dietary Supplement|follow on formula without probiotics|A follow on formula without probiotics
16289013|NCT00724204|Dietary Supplement|follow on formula with Lactobacillus salivarius CECT5713|follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
16289014|NCT00724191|Procedure|MRI|New MRI methods which measure information related to water, blood, and chemical makeup in the brain.
16289015|NCT00724178|Dietary Supplement|cholecalciferol plus calcium carbonate|oral calciferol 100,000 IU by mouth bimonthly and calcium carbonate (1 gr) by mouth daily
16289016|NCT00724165|Behavioral|Intervention|Culturally-modified, individually tailored physical activity print materials
16289017|NCT00724165|Behavioral|Control|Bilingual health education booklets
16289018|NCT00724152|Behavioral|Cognitive Behavioral Therapy|A psychotherapeutic approach to tinnitus management which includes tinnitus education
16289019|NCT00724152|Behavioral|Tinnitus Education|An audiologic rehabilitative approach to tinnitus education.
16289020|NCT00724139|Device|: APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel|training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle
16289021|NCT00724126|Drug|Rifaximin|
16289022|NCT00724126|Drug|Placebo|
16289023|NCT00724113|Procedure|infiltration intra articular|infiltration intra articular at inclusion with XYLOCAINE 1%
16289024|NCT00724113|Procedure|ARTHRO distension plus intensive mobilisation|ARTHRO distension plus intensive mobilisation
16289025|NCT00724100|Drug|ALB 109564(a) (12´-methylthiovinblastine dihydrochloride)|Starting dose is 1.2 mg/m2. Standard dose increase, in the absence of limiting toxicity, is 50%. Each dose of ALB 109564(a) will be administered by intravenous infusion once every 3 weeks (21-day cycle) over a period of time up to approximately 30 minutes. Number of cycles: Maximum of 12, until disease progression, or unacceptable toxicity develops. Greater than 12 cycles if disease has not progressed after 12 cycles, with Investigator's and Sponsor's approvals.
16289026|NCT00724087|Other|5.5-hour bedtime|16 days with sleep allowed only during a 5.5-hour bedtime period at night
16289027|NCT00724087|Other|8.5-hour bedtime|16 days with sleep allowed only during a 8.5-hour bedtime period at night
16289028|NCT00724074|Device|On-Q PainBuster with Bupivacaine|On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic
16289029|NCT00724074|Device|Usual Care|Usual Care
16289030|NCT00724061|Biological|Pegylated interferon α-2b|PEG-IFN-α-2b will be administered subcutaneously once a week. The starting dose of PEG-IFN-α-2b will be 1.5μg/kg. Each patient will undergo dose escalation to 3, 4.5, 6, 7.5, and up to 9μg/kg every 2 weeks or to maximum tolerated dose will be allowed. If no dose limiting toxicity (DLT) is observed, the maximum dose reached will be expanded. Once this dose has been given weekly for 2 weeks with no DLT, therapy will continue at this dose for up to 1 year depending on response.
16289031|NCT00724061|Other|Psoralens with ultraviolet light A|Oral psoralen (8-methoxypsoralen, 0.6-1.0 mg/kg) will be taken 1.5 to 2 hours prior to UVA treatment. The initial UVA dosage will be approximately 0.5 to 1.5 J/cm2, and will be increased in increments as determined by skin type and tolerability. PUVA therapy will be given 2-3 times per week until complete remission (CR) is achieved. Afterwards, additional maintenance therapy will be given with a gradual reduction from once a week to every 4-6 weeks up to 1 year after CR was achieved.
16289153|NCT00723242|Drug|Viraferon-peg and Rebetol|
16289154|NCT00723229|Drug|acyclovir|Acyclovir 400 mg PO BID for 28 days
16289155|NCT00723216|Drug|enoxaparin|20 mg twice a day
16289032|NCT00724061|Other|Narrowband-ultraviolet light B|The initial NB-UVB dose will be 70% of the patient's MED and approximately 0.2 J/cm2 and will be increased by 15% of each subsequent treatment as determined by skin type and/or tolerability. Therapy will be given 3 times per week until complete remission (CR) is achieved. Additional maintenance therapy will be administered while gradually reducing NB-UVB from thrice weekly to once a week. All patients will continue maintenance NB-UVB therapy until 1 year after they have achieved CR.
16289033|NCT00724048|Drug|ACR16 10 mg|ACR16 capsules: 10mg twice daily
16289034|NCT00724048|Drug|ACR16 22.5 mg|ACR16 capsules: 22.5mg twice daily
16289035|NCT00724048|Drug|ACR16 45 mg|ACR16 capsules: 45mg twice daily
16289036|NCT00724048|Other|Placebo|Placebo capsules
16289037|NCT00724035|Drug|Midazolam|"Procedural sedation before the execution of the block.
~0.03 mg/kg iv bolus"
16289038|NCT00724035|Drug|Ropivacaine|0.75% (wt/vol) solution, 20 ml perineural injection
16289039|NCT00724035|Drug|Fentanyl|50 µg iv bolus prn for pain during surgery, up to 150 µg
16289040|NCT00724035|Procedure|General anesthesia|General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.
16289041|NCT00724035|Procedure|Axillary brachial plexus nerve block|"Blocks will be performed under high-resolution real-time ultrasound guidance.
~Patients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery.
~A 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose."
16289042|NCT00724035|Procedure|Infraclavicular brachial plexus block|"Blocks will be performed under high-resolution real-time ultrasound guidance.
~Patients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane.
~The axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks."
16289043|NCT00724022|Drug|Basiliximab, Tacrolimus, MMF, Prednisolon|Control group. Therapy with Prednisolon.
16289044|NCT00724022|Drug|Basiliximab, Tacrolimus, MMF|No Prednisolon after 7 days
16289045|NCT00724022|Drug|Tacrolimus, MMF, rATG|Induction therapy: rATG instead of Basiliximab. No Prednisolon.
16289046|NCT00724009|Drug|Clofarabine|Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.
16289047|NCT00723996|Behavioral|Behavioral Study in Women|A Randomized study to assess the knowledge of womens health related issues
16289048|NCT00723983|Drug|Sumatriptan succinate|Sumatriptan succinate 50 mg taken orally
16289049|NCT00723983|Drug|NP101 Study Patch|NP101 study patch 4 hour application
16289050|NCT00723970|Drug|Quetiapine Extended Release|Quetiapine XR, 150-300 mg QHS, for 8 weeks
16289051|NCT00723957|Drug|Ixabepilone, 32 mg/m^2|Intravenous (IV) solutions, ixabepilone, 32 mg/m^2
16289052|NCT00723957|Drug|Paclitaxel, 200 mg/m^2|IV solutions, paclitaxel, 200 mg/m^2
16289053|NCT00723957|Drug|Carboplatin (area under the concentration curve [AUC] 6)|Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
16289054|NCT00723944|Device|Osseotite Certain Prevail|Root form titanium dental implant
16289055|NCT00723944|Device|Osseotite Certain|Dental implant without the lateralized design
16289056|NCT00723931|Biological|Peginterferon alfa-2b (SCH 54031)|Surveillance will be conducted after administration of peginterferon alfa-2b (administered according to the directions on the products' labeling). PegIntron Injection for surveillance is a weight-based dosing product administered at a dose of 0.5/1.0 ug/kg or 1.5 ug/kg. Administration of treatment is not part of this study.
16289057|NCT00723918|Drug|SAB378|SAB 15 mg per day for 5 days, the 15 mg BID (twice a day) for 5 days, then 15 mg TID (three times a day) to end of 28-day treatment period, in combination with active methadone 5 mg BID for 5 days, then 5 mg TID for 5 days, to maximum of 10 mg TID until end of 28-day treatment period
16289058|NCT00723918|Drug|methadone|Methadone 5 mg BID (twice a day) for 5 days, then 5 mg TID (three times a day) for 5 days, to maximum of 10 mg TID, in combination with SAB placebo or SAB active drug titrated as above, to end of 28-day treatment period.
16289059|NCT00723918|Drug|SAB placebo|an inactive substance
16289060|NCT00723918|Drug|Methadone placebo|Methadone placebo
16289061|NCT00723892|Biological|Peginterferon alfa-2b (PegIntron)|Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week
16289062|NCT00723892|Drug|Rebetol (Ribavirin)|Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day
16289063|NCT00723892|Behavioral|Psychotherapy support program|Each site has implemented a psychotherapy support program.
16289064|NCT00723879|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16289065|NCT00723879|Drug|Ribavirin (SCH 18908)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16289066|NCT00723879|Behavioral|Patient assistance program|"Patient assistance programs will be classified as follows:
~medications, including psychiatric medications (antidepressants);
~other interventions, including nurse telephone calls and nurse support in the office: and
~educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment."
16289067|NCT00723866|Other|BtxA+mCIMT|The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
16289068|NCT00723866|Other|BtxA+ conventional rehabilitation|The control group received for 2 hours/day, 3 days/week for 3 months.
16289156|NCT00723216|Other|Physical prophylaxis|
16289069|NCT00723853|Behavioral|Reach-Out Program, nutritional and exercise program|"This group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children.
~During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise."
16289070|NCT00723853|Behavioral|Reach-In Program, standard of care|This group will received standard medical care for their health condition. This includes meeting individually with a dietician to learn about diet, exercise and diabetes. This also includes developing an individualized meal plan.
16289071|NCT00723840|Other|Observational Studies: participants treated according to the real clinical practice.|No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
16289072|NCT00723827|Drug|Temozolomide|Administration of temozolomide based on the product labeling.
16289073|NCT00723827|Radiation|Radiotherapy|Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
16289074|NCT00723801|Drug|Atenolol|Atenolol 50mg PO QD
16289075|NCT00723801|Drug|Losartan|Losartan 100mg PO QD
16289076|NCT00723788|Device|MRI of the abdomen|Multiple MRI pulse sequences of the abdomen
16289077|NCT00723775|Drug|GSK706769 & KALETRA|GSK706769 alone and GSK706769 + Kaletra
16289078|NCT00723762|Procedure|Specimen collection|A blood sample and a spot urine sample will be obtained from all eligible patients receiving VPA at the start of the study.
16289079|NCT00723749|Drug|Buprenorphine/Naloxone|"Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine & 0.5 mg naloxone and 8 mg buprenorphine & 2 mg naloxone.
~The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity."
16289080|NCT00723736|Drug|Desloratadine|2.5 ml (1.25 mg) once daily
16289081|NCT00723723|Drug|Statin|Statin
16289082|NCT00723710|Biological|Intron A (interferon alfa-2b; SCH 30500)|The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects.
16289083|NCT00723697|Drug|buprenorphine|0.4, 2, or 8 mg sublingual tablets
16289084|NCT00723684|Other|Placebo EEG Neurofeedback|"The placebo EEG-neurofeedback group will get an identical procedure as the real EEG-Neurofeedback, but with feedback on a EEG signal simulation. The placebo group will not be rewarded on their real-time EEG but on a random, simulated EEG; known to be effective for this purpose (Utrecht University, study in progress).
~In the protocol selection the electrode position and rewarding versus inhibition of the treatment frequency band or bands will be individually created. The first 30 seconds of the treatment will start on a predetermined fixed threshold value for all treatment subjects."
16289085|NCT00723684|Other|EEG-Neurofeedback|The EEG-neurofeedback group will receive feedback on their real-time EEG-signal (brain activity). The treatment group will be rewarded, by brightening (i.e. not being blackened of) the feedback screen. Rewards will be given to the subjects when their digitally filtered frequency EEG activity meets the criteria in the 'percentage time over threshold' parameter. The 'percentage time over threshold' parameter will be auto-adjusted on the digitally filtered real-time EEG every 30 seconds, and the percentage parameter will be kept as a constant over all participants during the entire study (i.e. not adjusted during treatment based on individual capabilities).
16289086|NCT00723671|Procedure|MRI|
16289087|NCT00723658|Biological|rituximab|
16289088|NCT00723658|Drug|bortezomib|
16289089|NCT00723658|Drug|carmustine|
16289090|NCT00723658|Drug|cisplatin|
16289091|NCT00723658|Drug|cyclophosphamide|
16289092|NCT00723658|Drug|cytarabine|
16289093|NCT00723658|Drug|dexamethasone|
16289094|NCT00723658|Drug|doxorubicin hydrochloride|
16289095|NCT00723658|Drug|etoposide|
16289096|NCT00723658|Drug|melphalan|
16289097|NCT00723658|Drug|thalidomide|
16289098|NCT00723658|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|
16289099|NCT00723658|Procedure|peripheral blood stem cell transplantation|
16289100|NCT00723632|Biological|peginterferon alfa-2b|Peginterferon alfa-2b administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
16289101|NCT00723632|Drug|ribavirin|Ribavirin administered in accordance with approved labeling, ie, 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg, administered orally for 48 weeks for participants with HCV genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
16289102|NCT00723606|Drug|Intramuscular ziprasidone mesylate|The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.
16289103|NCT00723606|Drug|Intramuscular haloperidol|The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
16289104|NCT00723580|Drug|risperidone|Five treatment conditions: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.).
16289157|NCT00723203|Drug|panobinostat|40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
16289105|NCT00723554|Drug|Iloprost PD-6|Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
16289106|NCT00723554|Drug|Iloprost PD-15|"Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.
~Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day"
16289107|NCT00723541|Procedure|Computer aided analysis of breast lesions|Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.
16289108|NCT00723528|Drug|Placebo (CP)|Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
16289109|NCT00723528|Drug|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
16289110|NCT00723528|Drug|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
16289111|NCT00723528|Drug|Placebo A (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
16289112|NCT00723528|Drug|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
16289113|NCT00723528|Drug|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
16289114|NCT00723528|Drug|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
16289115|NCT00723515|Drug|sodium fluoride|sodium fluoride 5%
16289116|NCT00723515|Drug|sodium fluoride calcium fluoride|sodium fluoride 5% + calcium fluoride
16289117|NCT00723502|Drug|Finafloxacin + Amoxicillin|Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Amoxicillin, tablet 1000 mg b.i.d. (1 X 1000 mg tablet), oral administration
16289118|NCT00723502|Drug|Finafloxacin + Esomeprazole|Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Esomeprazole, tablet, 40 mg b.i.d. (1 X 40 mg tablet), oral administration
16289119|NCT00723489|Biological|Live Yellow Fever Vaccine (YFV-17D)|
16289120|NCT00723489|Drug|YFV-17D Placebo|
16289121|NCT00723476|Behavioral|Family Centered Advanced Care Planning (FCACP) sessions|FCACP will include three 60- to 90-minute weekly sessions. Sessions consisting of structured conversations with HIV infected adolescents, their proxies, and trained facilitators will aim to enhance quality of life by integrating effective end-of-life (EOL) care and minimizing depression and anxiety. The three sessions will consist of a structured EOL survey, an FCACP interview, and a family problem-solving lesson.
16289122|NCT00723476|Behavioral|Health education control sessions|Health education control sessions will include three 60- to 90-minute sessions and will involve adolescents with HIV/AIDS and their proxies. Topics covered during sessions will include developmental history, planning for the future, and safety tips.
16289123|NCT00723463|Procedure|3T MRI scan|Establishing/evaluating apparent diffusion coefficient (ADC) values using a 3T MRI scan to differentiate tumors from normal tissue.
16289124|NCT00723450|Drug|lamictal|Flexible Dosing
16289125|NCT00723437|Drug|acitretin|Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.
16289126|NCT00723424|Drug|AZD5672|50 mg, for 13 days
16289127|NCT00723424|Drug|Digoxin|0.5mg dose
16289128|NCT00723411|Drug|rhGAD65|Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
16289129|NCT00723411|Drug|rhGAD65|Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
16289130|NCT00723411|Drug|Placebo|Placebo injected subcutaneously at days 1, 30, 90 and 270
16289131|NCT00723398|Dietary Supplement|Lovaza 4gm oral|Dietary supplement; Take 4 mg oral capsules daily
16289132|NCT00723398|Drug|Raloxifene 60 Mg Oral Tablet|60 mg orally every day for two years
16289133|NCT00723398|Drug|Raloxifene 30 Mg Oral Tablet|30 mg orally daily for two years
16289134|NCT00723398|Drug|Lovaza 4gm & Raloxifene 30mg|Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years
16289135|NCT00723385|Dietary Supplement|Vitamin D (1000 or 2000 IU/day)|Dose titration beginning with 1000 IU/day and either remaining at 1000 IU/day for weeks 7-12 if normalized D levels at 6 weeks or increasing to 2000 IU/day for weeks 7-12 if levels not normalized at week 6
16289136|NCT00723385|Other|Placebo|Administration of placebo for 12 weeks with repeated D measurements
16289137|NCT00723359|Drug|BT062|biologic
16289138|NCT00723346|Biological|GRASPA|50 UI/Kg
16289139|NCT00723346|Biological|GRASPA|100 UI/Kg
16289140|NCT00723346|Biological|GRASPA|150 UI/Kg
16289141|NCT00723346|Drug|native L asparaginase|10000UI/m2, 14 infusions during 4 chemotherapy cycle
16289142|NCT00723333|Procedure|Reduced Intensity Conditioning (RIC) Allogenic Transplant|Reduced Intensity Conditioning (RIC) Regimen Allogenic Stem Cell Transplant
16289143|NCT00723320|Drug|Atorvastatin|atorvastatin 10mg/d
16289144|NCT00723320|Behavioral|Aggressive lifestyle intervention|aggressive lifestyle intervention
16289145|NCT00723307|Drug|Metformin|White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
16289146|NCT00723307|Drug|Placebo|White coated tablet; one tablet twice daily; 1.5 years duration
16289147|NCT00723294|Procedure|cryosurgery|
16289148|NCT00723294|Procedure|therapeutic conventional surgery|
16289149|NCT00723268|Drug|Prednisolone|5MG Prednisolone per day for 3 months
16289150|NCT00723268|Drug|Colchicine|0.5 MG Colchicine per day for 3 months
16289158|NCT00723203|Genetic|gene expression analysis|Day 1 and day 28 samples
16289159|NCT00723203|Genetic|reverse transcriptase-polymerase chain reaction|Day 1 and day 28 samples
16289160|NCT00723203|Other|laboratory biomarker analysis|Day 1 and day 28 samples
16289161|NCT00723190|Drug|CLONICEL (Clonidine HCl sustained release)|0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4
16289162|NCT00723177|Drug|AV411|Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks
16289163|NCT00723177|Drug|Placebo (PCB)|Placebo drug will be administered orally twice a day (BID) for two consecutive weeks
16289164|NCT00723164|Drug|Fentanyl and Midazolam|A combination of fentanyl 0.6 ug/kg and midazolam 9 ug/kg, to which NaCl was added to obtain a volume of 2.5 mL (group FM) injected IV, 5 minutes prior inhalation induction of anesthesia with sevoflurane
16289165|NCT00723164|Drug|NaCl|NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
16289166|NCT00723151|Behavioral|Milieu Communication Teaching|Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
16289167|NCT00723125|Drug|Abraxane|Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks
16289168|NCT00723125|Drug|Carboplatin|Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10
16289169|NCT00723125|Drug|Avastin|Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
16289170|NCT00723099|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo umbilical cord blood transplant
16289171|NCT00723099|Drug|Cyclophosphamide|Given IV
16289172|NCT00723099|Drug|Cyclosporine|Given IV
16289173|NCT00723099|Drug|Fludarabine Phosphate|Given IV
16289174|NCT00723099|Other|Laboratory Biomarker Analysis|Correlative studies
16289175|NCT00723099|Drug|Mycophenolate Mofetil|Given IV or PO
16289176|NCT00723099|Radiation|Total-Body Irradiation|Undergo TBI
16289177|NCT00723099|Procedure|Umbilical Cord Blood Transplantation|Undergo umbilical cord blood transplant
16289178|NCT00723086|Drug|docetaxel (XRP6976)|combined treatment with prednisolone
16289179|NCT00723060|Drug|escitalopram|escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
16289180|NCT00723047|Procedure|Fibrin glue injection in fistula|
16289181|NCT00723021|Drug|PF-04191834|30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
16289182|NCT00723021|Drug|PF-04191834|100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
16289183|NCT00723021|Drug|PF-04191834|2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose
16289184|NCT00723021|Drug|zileuton|1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
16289185|NCT00723021|Drug|Placebo|2 x placebo tablets + placebo oral dispersion, single dose.
16289186|NCT00723008|Device|Alpha Stim 100 (Cranial Electrotherapy Stimulation)|cranial electrical stimulation 100 microamps
16289187|NCT00722995|Procedure|Sleeve gastrectomy|Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
16289188|NCT00722995|Procedure|Gastric Bypass|Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
16289189|NCT00722969|Drug|sorafenib + erlotinib|sorafenib 400mg b.i.d oral Erlotinib 150 mg o.i.d oral
16289190|NCT00722956|Drug|AZD5672|100 mg once daily, 10 days
16289191|NCT00722956|Drug|atorvastatin|one single dose of 40 mg on day 10
16289192|NCT00722943|Other|Developmental Massage Therapy|Tactile stimulation and massage will be done by a licensed therapist
16289193|NCT00722943|Other|no intervention|The infant will not be touched by the therapist.
16289194|NCT00722930|Drug|Y90 Ibritumomab Tiuxetan|Consolidation with Y90 Ibritumomab Tiuxetan
16289195|NCT00722917|Drug|TAK-379|TAK-379 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
16289196|NCT00722917|Drug|TAK-379|TAK-379 100 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
16289197|NCT00722917|Drug|TAK-379|TAK-379 200 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
16289198|NCT00722917|Drug|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily and TAK-379 placebo-matching tablets, orally, once daily for up to 12 weeks
16289199|NCT00722917|Drug|Placebo|TAK-379 placebo-matching tablets, orally, and pioglitazone placebo-matching tablets, orally, once daily for up to 12 weeks
16289200|NCT00722891|Device|Purevision Lenses with ReNu Multiplus|Purevision lenses using ReNu Multiplus lens solution for 28 days
16289201|NCT00722891|Device|Purevision Lenses with Optifree RepleniSH|Purevision lenses using Optifree RepleniSH lens solution for 28 days
16289202|NCT00722865|Drug|Avastin|Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
16289203|NCT00722852|Drug|ketoprofen in Diractin®|100 mg (b.i.d.)
16289204|NCT00722852|Drug|Placebo|100 mg (b.i.d.)
16289205|NCT00722839|Biological|PADRE-CMV fusion peptide vaccine|Given subcutaneously
16289206|NCT00722839|Biological|tetanus-CMV fusion peptide vaccine|Given subcutaneously
16289207|NCT00722839|Drug|agatolimod sodium|Given subcutaneously
16289208|NCT00722813|Other|Survey|To determine patient preference for the two tests CT angiography (CTA) and catheter coronary angiography (CCA).
16289209|NCT00722800|Drug|drospirenone and ethinyl estradiol (YAZ)|1 tablet daily for 24 weeks
16289210|NCT00722800|Drug|Placebo|1 tablet daily for 24 weeks
16289211|NCT00722774|Biological|H2N2 1960 AA ca recombinant vaccine|Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
16289212|NCT00722761|Drug|drospirenone and ethinyl estradiol|Drosperinone (3mg) and ethinyl estradiol (0.02mg) tablet given once daily for 24 weeks
16289213|NCT00722761|Drug|Placebo tablet|Placebo tablet (no active drug) given once daily for 24 weeks
16289214|NCT00722735|Drug|Finafloxacin|Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
16289215|NCT00722735|Drug|Ciprofloxacin|Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days
16289216|NCT00722722|Drug|Bortezomib|Velcade given in four-dose cycles intravenously (through a vein).
16289217|NCT00722709|Drug|Ropivacaine|"In the treatment arm patients will receive 10mls 0.75% ropivacaine diluted to 50mls with saline immediately before closure.
~At closure, two small 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump (On-Q pain buster). This pump will contain 270mls of 0.2% ropivacaine. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal."
16289218|NCT00722709|Drug|0.9% Saline|"In the placebo arm patients will receive 50 ml 0.9% saline into the peritoneum soon after the creation of the laparotomy.
~At closure, two 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump on-Q pain buster). This pump will contain 0.9% saline. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal."
16289219|NCT00722696|Other|physical training|8 weeks of hiking downwards. For the opposite way, a cable car will be used.
16289220|NCT00722683|Procedure|Ultrasound Imaging with Contrast|"An ultrasound contrast agent, Definity, will be administered started through the IV line already in use. The imaging will be performed to map vascular flow.
~The breast will be scanned by a double ultrasound transducer system in a holder over the area of the breast to be biopsied. The machine will be set with different settings and the scan repeated, possibly multiple times."
16289221|NCT00722670|Behavioral|Woman-focused intervention|Participants in this group received a four individual sessions of the woman-focused intervention, in addition to services that were part of their substance abuse treatment program
16289222|NCT00722670|Behavioral|Treatment as Usual|Participants in this group only received services that were part of their substance abuse treatment program
16289223|NCT00722644|Behavioral|Cognitive Behavioral Stress Management|
16289224|NCT00722631|Drug|Pioglitazone|Subjects who meet eligibility criteria will be titrated up to a maximum of 30 mg/day pioglitazone.
16289225|NCT00722631|Drug|Glimepiride|Subjects who meet eligibility criteria will be titrated up to a maximum of 4 mg/day glimepiride.
16289226|NCT00722618|Behavioral|Written materials, telephone based education|4 new written materials, 15-20 minute educational session by telephone
16289227|NCT00722618|Other|Written materials|2 written materials available on public website
16289228|NCT00722605|Procedure|cone-beam CT|"You will have the following CT scans along with the standard weekly portal images:Before treatment you will have a CT scan (a respiratory-correlated CT scan) at the time of the radiation planning, or simulation planning.During the first week of treatment - you will have 5 cone-beam CT scans at days 1 through 5 of your radiation treatment schedule.
~During the remaining weeks of treatment - you will have a cone-beam CT scan every week. Depending on the number of treatments that your study doctor has prescribed for you, the number of weekly scans can be between 3 and 7.
~For all scans, an external monitor will be used to record your breathing.
~If needed, you will be repositioned by adjusting the radiation machine's treatment couch position."
16289229|NCT00722592|Drug|Vintafolide|2.5 mg IV bolus on Days 1,3,5 and 15,17,19 of a 4-week cycle
16289230|NCT00722592|Drug|pegylated liposomal doxorubicin (PLD)|50 mg/m^2 (with dose based on ideal body weight for participants whose measured body weight is greater than their ideal body weight) intravenous infusion on Day 1 of a 4 week cycle. Dose reductions permitted for toxicity.
16289231|NCT00722592|Other|EC20|During the screening period, participants at centers with EC20 imaging capability will receive a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure. A second injection and imaging may be done after all therapy with the study drugs is done.
16289232|NCT00722579|Device|PRESILLION cobalt chromium stent|PTCA with bare-metal stent
16289233|NCT00722566|Drug|VELCADE Administered by subcutaneous injection|Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
16289234|NCT00722566|Drug|VELCADE Administered by intravenous infusion|Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
16289235|NCT00722553|Drug|Pralatrexate Injection|"Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).
~Initial dose: 190 mg/m2
~Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.
~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."
16289236|NCT00722553|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
16289237|NCT00722553|Dietary Supplement|Folic Acid|"1-1.25 mg orally
~Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate."
16289238|NCT00722540|Drug|NNC126-0083|Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16289239|NCT00722540|Drug|NNC126-0083|Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16289240|NCT00722540|Drug|NNC126-0083|Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16289241|NCT00722540|Drug|NNC126-0083|Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289242|NCT00722540|Drug|placebo|Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289243|NCT00722540|Drug|placebo|Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289244|NCT00722540|Drug|placebo|Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289245|NCT00722540|Drug|placebo|Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289246|NCT00722540|Drug|NNC126-0083|Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16289247|NCT00722540|Drug|placebo|Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16289326|NCT00721955|Drug|Inhaled loxapine 10 mg|Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
16289248|NCT00722514|Behavioral|patient education|"complex individual antiinflammatory rehabilitation program during inpatient rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally
~Patient education 6 x 90 Minutes"
16289249|NCT00722514|Behavioral|Standard Care|"complex individual antiinflammatory rehabilitation program during inpatient
~complex individual medical rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally
~further 6 treatments from available disciplines(e.g. massage, electrotherapy, bath)"
16289250|NCT00722501|Drug|ERB-257|
16289251|NCT00722501|Other|placebo|
16289252|NCT00722488|Drug|MLN4924|Intravenous dose 100 mg/m2 on a Days 1,4,8,11 schedule within a 21-day treatment cycle. Treatment may continue until disease progression or unacceptable toxicity develops.
16289253|NCT00722475|Drug|Intravenous immunoglobulin|Intravenous infusions, 25-35 g each time, 4th to 15th gestational week
16289254|NCT00722475|Drug|Human albumin|Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week
16289255|NCT00722462|Procedure|Active acupuncture|Acupuncture 25 minutes before and after embryo transfer
16289256|NCT00722462|Procedure|Sham acupuncture|Acupuncture at neutral points, 25 minutes before and after embryo transfer
16289257|NCT00722436|Drug|Tranexamic acid|100 mg/kg load, then 10 mg/kg/hr
16289258|NCT00722436|Drug|saline|Placebo
16289259|NCT00722423|Behavioral|Integrated care model|The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
16289260|NCT00722423|Behavioral|Usual Care Model|
16289261|NCT00722410|Dietary Supplement|VSL#3|A probiotic preparation.
16289262|NCT00722410|Drug|Polyethylene glycol|Oral ingestion of 3 liters of polyethylene glycol solution.
16289263|NCT00722384|Drug|bevasiranib|
16289264|NCT00722384|Drug|bevasiranib|The first three patients enrolled will receive 0.1 mg Cand5 in the study eye, the next three patients enrolled will receive 0.33 mg Cand5 in the study eye, the following three patients enrolled will receive 1.0 mg Cand5 in the study eye, the following three patients enrolled will receive 1.5 mg Cand5 in the study eye, and the remaining three patients enrolled will receive 3.0 mg Cand5 in the study eye. The third patient enrolled at each dose level will complete their two-week visit before the next dose level group may be treated.
16289265|NCT00722371|Drug|Sitagliptin phosphate|Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
16289266|NCT00722371|Drug|Pioglitazone hydrochloride|Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
16289267|NCT00722371|Drug|Matching placebo to sitagliptin|Matching placebo to sitagliptin orally once daily for 54 weeks.
16289268|NCT00722371|Drug|Matching placebo to pioglitazone|Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
16289269|NCT00722371|Drug|Metformin|Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
16289270|NCT00722358|Drug|BMS-650032|"Capsule, Oral, Q12h, 3/5 days
~Panel 1: 200 mg
~Panel 2: 400 mg
~Panel 3: 600 mg"
16289271|NCT00722358|Drug|Placebo|"Capsule, Oral, Q 12h, 3/5 days
~Panel 1: matching placebo
~Panel 2: matching placebo
~Panel 3: matching placebo"
16289272|NCT00722345|Behavioral|"review of Canada's Physical Activity Guide for Youth"|"The contents of the exercise booklet was reviewed with each participant of the control group by the research fellow. Health Canada's Canada's Physical Activity Guide for Youth was used for the exercise booklet"
16289273|NCT00722345|Behavioral|Exercise consultation|The exercise consultation consisted of a one-to-one discussion designed to educate the participant, strengthen his/her motivation and develop realistic goals and strategies to promote physical activity based on the patient's stage of change. The consultation was based upon the standardized protocol previously published by Loughlan and Mutrie. The Consultation Guidelines describe the 5 steps involved in an exercise consultation, including: 1) discussing current & past activities; 2) reviewing the pros & cons of exercising; 3) discussing the barriers to exercising and strategies for overcoming them; 4) determining the social support available to the patient; and finally, 5) setting realistic, attainable short term and long term goals to enhance physical activity.
16289274|NCT00722332|Biological|HepaGam B|Hepatitis B Immunoglobulin
16289275|NCT00722306|Drug|PD 0200390|Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose
16289276|NCT00722293|Drug|Doxorubicin|Arm D - doxorubicin given as a intravenous bolus injection on Day 1 or Day 3 depending on schedule selected from Arm A, B or C - starting dose 60 mg/m2 and increase to 75mg/m2
16289277|NCT00722293|Drug|Pazopanib (GW786034)|Arm A - daily administration of pazopanib on Days 1 through 21 starting at 200mg with a maximum dose of 800mg; Arm B daily administration of pazopanib on Days 1 through 8 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm C daily dose of pazopanib on Days 14 through 21 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm D once daily administration of pazopanib (according to schedule selected from Arm A, B, or C) starting at 400mg escalating to a maximum dose of 800mg
16289278|NCT00722293|Drug|Epirubicin|Arm A and Arm B - epirubicin given as a bolus intravenous injection on Day 3 starting dose 60mg/m2 increase to 90mg/m2 if tolerated; Arm C - epirubicin given as a bolus intravenous injection on Day 1 starting dose 60mg/m2 increase to 90mg/m2 if tolerated
16289327|NCT00721929|Procedure|MRI|Magnetic Resonance Imaging
16289328|NCT00721916|Drug|SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)|L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
16289563|NCT00720369|Drug|CoEnzyme Q10|CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day
16289279|NCT00722280|Procedure|Hand Transplantation|"This program is the primary site for a novel immune modulation protocol for hand and/or forearm transplantation using donor bone marrow stem cells. This protocol, otherwise called the Pittsburgh Protocol has been published and implemented in 8 hand/forearm transplantations. The Pittsburgh hand transplant program is the only center that has experience with the Pittsburgh Protocol to reduce the number and dosing of immunosuppressive drugs used to prevent rejection of hand/forearm transplants."
16289280|NCT00722228|Biological|Autologous or Allogeneic tumor cells|Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.
16289281|NCT00722215|Drug|BQ-123 (selective endothelin A receptor antagonist)|Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously.
16289282|NCT00722215|Drug|0.9 % saline|Single 15ml 0.9% saline infused for 15 mins as placebo control
16289283|NCT00722215|Drug|Nifedipine|Single dose of nifedipine 10 mg given orally as active control
16289284|NCT00722202|Drug|ERB-257|
16289285|NCT00722202|Other|placebo|
16289286|NCT00722176|Drug|BL-1020|10 mg
16289287|NCT00722176|Drug|BL-1020 10-30 mg|BL-1020 10-30 mg
16289288|NCT00722176|Drug|risperidone|risperidone
16289289|NCT00722163|Other|Cognitive Behavioural Therapy|
16289290|NCT00722163|Other|befriending|
16289291|NCT00722150|Drug|Artesunate|2 mg/kg/day x 7 days
16289292|NCT00722150|Drug|Artesunate|4 mg/kg/day x 7 days
16289293|NCT00722150|Drug|Artesunate|6 mg/kg/day x 7 days
16289294|NCT00722137|Drug|Rituximab 375 mg/m^2|Intravenous rituximab 375 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.
16289295|NCT00722137|Drug|Cyclophosphamide 750 mg/m^2|Intravenous cyclophosphamide 750 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
16289296|NCT00722137|Drug|Doxorubicin 50 mg/m^2|Intravenous doxorubicin 50 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
16289297|NCT00722137|Drug|VELCADE 1.3 mg/m^2|Intravenous VELCADE 1.3 mg/m^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles
16289298|NCT00722137|Drug|Prednisone 100 mg/m^2|Oral prednisone 100 mg/m^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles
16289299|NCT00722137|Drug|Vincristine 1.4 mg/m^2|Intravenous vincristine 1.4 mg/m^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.
16289300|NCT00722124|Drug|S-Adenosyl-L-Methionine|800 mg dose per day for 8 weeks
16289301|NCT00722124|Drug|S-Adenosyl-L-Methionine|1600 mg per day for 8 weeks
16289302|NCT00722124|Other|placebo|4 pills (2 in the AM and 2 in the PM) of placebos for 8 weeks
16289303|NCT00722111|Device|lingual press|lingual press (high-intensity, oral, non-swallowing)
16289304|NCT00722111|Behavioral|effortful swallowing|effortful swallowing (high-intensity swallowing)
16289305|NCT00722111|Behavioral|natural swallowing|natural swallowing (high frequency, low intensity swallowing)
16289306|NCT00722111|Behavioral|non-oral sham (control) exercise|non-oral sham (control) exercise
16289307|NCT00722098|Biological|DC Vaccine & Cyclophosphamide|"Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities.
~Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7."
16289308|NCT00722098|Biological|DC Vaccine & Placebo|"Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities.
~Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7."
16289309|NCT00722072|Drug|fulvestrant|Loading dose for cycle 1: 500 mg intramuscular(IM) on Day 1;250 mg IM on Day 15 Upon completion of the loading dose, a fixed dose of fulvestrant 250 mg IM will be administered on day 1 of the next 28 day cycle and every consecutive cycle until tumor progression or until unacceptable toxicity occurs requiring discontinuation of study therapy
16289310|NCT00722072|Drug|sorafenib tosylate|Subjects will take sorafenib 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy
16289311|NCT00722059|Procedure|Breast Tomosynthesis|3D breast imaging
16289312|NCT00722046|Biological|PF-04360365 0.1 mg/kg|0.1 mg/kg every 60 days (10 doses total)
16289313|NCT00722046|Biological|PF-04360365 0.5 mg/kg|0.5 mg/kg every 60 days (10 doses total)
16289314|NCT00722046|Biological|PF-04360365 1 mg/kg|1 mg/kg every 60 days (10 doses total)
16289315|NCT00722046|Drug|Placebo|Placebo every 60 days (10 doses total)
16289316|NCT00722046|Biological|PF-04360365 3 mg/kg|3 mg/kg every 60 days (10 doses total)
16289317|NCT00722046|Biological|PF-04360365 8.5 mg/kg|8.5 mg/kg every 60 days (10 doses total)
16289318|NCT00722033|Drug|3 protocols of Indomethacin administration|Indomethacin will consecutive be infused in 30, 60 and 120 minutes in each patient who requires it.
16289319|NCT00722020|Device|VEST|15 minutes of HFCWO via the Vest 2-3 times daily
16289320|NCT00722007|Device|Cormet Hip Resurfacing|Cormet Hip Resurfacing implant
16289321|NCT00721994|Device|Cormet Hip Resurfacing System|Cormet Hip Resurfacing System
16289322|NCT00721968|Device|Glaucoma Stent Surgery (GTS400 Stent)|ab interno trabecular bypass stent surgery
16289323|NCT00721968|Procedure|cataract surgery alone|Cataract surgery alone
16289324|NCT00721955|Drug|Inhaled Placebo|Inhaled loxapine Placebo, may repeat after 2 hours x 2
16289325|NCT00721955|Drug|Inhaled loxapine 5 mg|Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
16289329|NCT00721916|Drug|mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)|L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)
16289330|NCT00721903|Procedure|Ultrasound Scan|10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.
16289331|NCT00721903|Procedure|Mammography and Ultrasound|To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.
16289332|NCT00721890|Dietary Supplement|Double-Brewed Green Tea|liquid, 4 celsius; 500 mL ID, 3 hours after meals and 1 hour before next meal; duration: to the first of the following events: 18 months or relapse
16289333|NCT00721877|Drug|resveratrol|Given orally
16289334|NCT00721877|Other|pharmacological study|Correlative studies
16289335|NCT00721877|Other|laboratory biomarker analysis|Correlative studies
16289336|NCT00721825|Drug|Neuroaid|Neuroaid capsules, 4 capsules, three times per day, during one month
16289337|NCT00721825|Drug|Neuroaid matched Placebo|Neuroaid matched placebo 4 capsules three times per day during one month
16289338|NCT00721812|Drug|GSK1399686|Safety and tolerability dose escalation in normal human volunteers
16289339|NCT00721799|Drug|18F-Fluorothymidine PET scan|18F-Fluorothymidine (0.04 - 0.08 mCi / kg to a maximum dose of 5 mCi) administered once intravenously for a positron emission tomography (PET) scan.
16289340|NCT00721786|Behavioral|UCSF/SFGH Internet Stop Smoking Study site|Internet stop smoking site in Spanish and English
16289341|NCT00721773|Drug|Benazepril|Patients with hypertension will take 10-20mg benazepril per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
16289342|NCT00721773|Drug|Valsartan|Patients with hypertension will take 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
16289343|NCT00721773|Drug|Benazepril+Valsartan|Patients with hypertension will take 10-20mg benazepril plus 80-160mg valsartan per day, antihypertensive agents other than ACE inhibitors and ARBs will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
16289344|NCT00721773|Drug|Control|Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 120-140/70-90 mmHg.
16289345|NCT00721760|Drug|Enoxaparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16289346|NCT00721760|Drug|Semuloparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16289347|NCT00721760|Drug|Placebo|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component
~Subcutaneous injection"
16289348|NCT00721747|Drug|Docetaxel, Liposomal doxorubicine and Cyclophosphamide|4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
16289349|NCT00721734|Drug|Carfilzomib|Carfilzomib was administered intravenously (IV) at a rate of approximately 10 mL/minute.
16289350|NCT00721721|Behavioral|Low Sodium Diet|3 grams of salt or 51.3 mmol of sodium per day
16289351|NCT00721721|Behavioral|High Sodium Diet|18 grams of salt or 307.8 mmol of sodium per day
16289352|NCT00721721|Dietary Supplement|Potassium Supplementation|60 mmol potassium supplement
16289353|NCT00721708|Dietary Supplement|pure carnosine|one time dose of pure carnosine (450 mg)
16289354|NCT00721708|Other|Beef|one time dose, 150 g of beef
16289355|NCT00721708|Other|Chicken|One time dose, 150g of chicken breast
16289356|NCT00721708|Other|Chicken broth|one time dose of chicken broth obtained from 150g of chicken breast
16289357|NCT00721695|Drug|OMS302|OMS302 Irrigation Solution
16289358|NCT00721695|Drug|OMS302-PE|OMS302-PE HCI Irrigation Solution
16289359|NCT00721695|Drug|Vehicle|Standard topical mydriatics and Balanced Salt Solution Irrigation Solution
16289360|NCT00721669|Drug|IMGN388|IMGN388 is a human IgG1 anti-integrin antibody conjugated to the maytansinoid, DM4.
16289361|NCT00721656|Drug|Placebo|
16289362|NCT00721656|Drug|KLS-0611|
16289363|NCT00721643|Dietary Supplement|angel's plant (Angelica keiskei)|Healthy control, one time dose of 5g dry power of Angelica keiskei
16289364|NCT00721643|Dietary Supplement|Angel's plant (Angelica keiskei)|Metaboic syndrome subjects, one time dose of 5g dry powder of angel's plant (Angelica keiskei)
16289365|NCT00721630|Drug|capecitabine, lapatinib|Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
16289366|NCT00721617|Other|Intralipid 20%|Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.
16289367|NCT00721617|Other|Normal Saline|Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.
16289368|NCT00721617|Other|Oral fat load|Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).
16289369|NCT00721604|Drug|fluid administration|two consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes)
16289428|NCT00721240|Drug|montelukast|5mg montelukast once daily for 12 weeks
16289564|NCT00720356|Drug|bevacizumab|10mg/kg administered intravenously every 2 weeks
16289370|NCT00721578|Drug|voriconazole|Patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.
16289371|NCT00721565|Behavioral|Exercise Behavior Change|attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist
16289372|NCT00721552|Drug|Sitagliptin 100 mg|28 days administration of 100 mg daily
16289373|NCT00721552|Drug|Prednisolone 30 mg|14 days administration of 30 mg daily
16289374|NCT00721552|Drug|Sitagliptin-placebo|28 days administration once daily
16289375|NCT00721552|Drug|Prednisolone-placebo|14 days administration once daily
16289376|NCT00721539|Device|da Vinci Surgical Robot Platform|daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.
16289377|NCT00721539|Procedure|Transoral Robotic Surgery|Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
16289378|NCT00721526|Drug|disulfiram plus lorazepam|Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
16289379|NCT00721513|Biological|cetuximab|
16289380|NCT00721513|Drug|cisplatin|
16289381|NCT00721513|Drug|docetaxel|
16289382|NCT00721513|Drug|fluorouracil|
16289383|NCT00721513|Procedure|computed tomography|
16289384|NCT00721513|Procedure|positron emission tomography|
16289385|NCT00721513|Procedure|quality-of-life assessment|
16289386|NCT00721513|Radiation|3-dimensional conformal radiation therapy|
16289387|NCT00721513|Radiation|intensity-modulated radiation therapy|
16289388|NCT00721500|Device|etafilcon A|contact lens
16289389|NCT00721500|Device|narafilcon A|contact lens
16289390|NCT00721487|Drug|Fluconazole|Patients hospitalized with severe infection caused by C. albicans, documented by standard clinical signs, symptoms, and radiology, and having failed at least four days of fluconazole therapy
16289391|NCT00721474|Drug|Bosutinib|Bosutinib fasting
16289392|NCT00721474|Drug|Bosutinib|Bosutinib fed
16289393|NCT00721461|Biological|V930|Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.
16289394|NCT00721448|Drug|AZD6140|90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9
16289395|NCT00721448|Drug|AZD6140|90 x 2 mg tablets, oral, once daily for the first day and twice daily from day 4 to 9
16289396|NCT00721435|Procedure|3D Tomosynthesis and ultrasound imaging|3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue
16289397|NCT00721422|Drug|PD 0332334|50 mg (two 25 mg capsules), single, oral dose
16289398|NCT00721422|Drug|PD 0332334|50 mg (two 25 mg capsules), single, oral dose
16289399|NCT00721422|Drug|PD 0332334|50 mg (two 25 mg capsules), single, oral dose
16289400|NCT00721422|Drug|PD 0332334|50 mg (two 25 mg capsules), single, oral dose
16289401|NCT00721409|Drug|PD 0332991|125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
16289402|NCT00721409|Drug|letrozole|2.5 mg/d tablets orally on a continuous regimen
16289403|NCT00721409|Drug|letrozole|2.5 mg/d tablets orally on a continuous regimen
16289404|NCT00721396|Biological|rMenB+OMV NZ|
16289405|NCT00721396|Biological|combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine|
16289406|NCT00721396|Biological|Pneumococcal vaccine|
16289407|NCT00721383|Behavioral|Enhancing Physical Activity Intervention|Physical activity and caregiver skill-building
16289408|NCT00721383|Behavioral|CSBI|Caregiver skill-building
16289409|NCT00721370|Device|NIR imaging system|Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.
16289410|NCT00721357|Behavioral|Treadmill walking|Subjects will perform treadmill walking at a self-selected velocity
16289411|NCT00721357|Other|Magnetic resonance spectroscopy|Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
16289412|NCT00721344|Drug|Technosphere Inhalation Powder (FDKP)|Technosphere® Inhalation Powder 20mg
16289413|NCT00721344|Drug|Moxifloxacin|Tablets 400mg
16289414|NCT00721344|Drug|Technosphere Inhalation Powder (FDKP)|Technosphere® Inhalation Powder 40mg
16289415|NCT00721344|Drug|Placebo|Placebo cartridges
16289416|NCT00721331|Drug|nortriptyline HCl + loratadine|Topical
16289417|NCT00721331|Drug|nortriptyline HCl + loratadine|Topical
16289418|NCT00721331|Drug|nortriptyline HCl|Topical
16289419|NCT00721331|Drug|mometasone furoate|Topical
16289420|NCT00721331|Drug|Active ingredient free vehicle cream of CRx-197|Topical
16289421|NCT00721305|Drug|Lovastatin|Lovastatin 40 mg daily (2 tablets of 20 mg each, p.o.), during twelve months until the end of the study, or before the end of the study if any AIDS defining disease or toxicity appear
16289422|NCT00721305|Other|placebo|Placebo will be administered daily (2 tablets which will look externally identical to intervention: wrapped in the same way, with the same size, shape and color), during twelve months until the end of the study, or before the end of the study if any AIDS defining disease or toxicity appear
16289423|NCT00721279|Drug|Sifrol® (pramipexole dihydrochloride)|
16289424|NCT00721266|Drug|RO5083945|Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2).
16289425|NCT00721253|Device|ReSTOR|Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
16289426|NCT00721253|Device|Tecnis|Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
16289427|NCT00721253|Device|Acri.LISA|Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
16289429|NCT00721227|Procedure|Reduction Gastroplasty|"Subjects will undergo reduction gastroplasty by gastric plication
~Subjects are followed for 12 months to evaluate outcomes and potential complications."
16289430|NCT00721214|Drug|5-azacytidine|The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
16289431|NCT00721201|Drug|Mifepristone|Use of mifepristone 200mg bd for 8 weeks
16289432|NCT00721188|Drug|Venofer|Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
16289433|NCT00721175|Device|biliary stent (self expandable metallic stent)|metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
16289434|NCT00721175|Device|PS|plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
16289435|NCT00721162|Biological|Ramucirumab|Participants will receive ramucirumab at 8 milligrams/kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
16289436|NCT00721149|Device|Radiofrequency Ablation|The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
16289437|NCT00721136|Drug|continue warfarin through the procedure|The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
16289438|NCT00721136|Drug|Hold warfarin|For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
16289439|NCT00721136|Drug|Warfarin held with heparin transition.|For high risk patients, warfarin is held for 4-5 days prior to the procedure and heparin is given to provide anticoagulation while the INR is subtherapeutic.
16289440|NCT00721123|Drug|Tocilizumab|Tocilizumab (myeloma receptor antibody [MRA]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.
16289441|NCT00721110|Drug|Lidocaine|Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
16289442|NCT00721110|Drug|Placebo|Placebo boluses and infusions will be substituted
16289443|NCT00721110|Drug|Ketamine|Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
16289444|NCT00721110|Drug|Ketamine + Lidocaine|both Ketamine and Lidocaine will be given
16289445|NCT00721097|Other|spirometry, and blood taken|each month during one year
16289446|NCT00721071|Drug|Hypertonic Saline|After each subject has performed post-bronchodilator spirometry, he/she will inhale increasing concentrations of 3, 4, and 5% of hypertonic saline for 7 minutes each for 3 cycles until expectorating a sufficient sputum sample.
16289447|NCT00721058|Other|CT-scan|A pre-operative CT-scan will be made
16289448|NCT00721045|Biological|Mesenchymal Precursor Cells (MPCs)|25 M allogeneic MPCs by transendocardial injection and mapping.
16289449|NCT00721045|Biological|Mesenchymal Precursor Cells (MPCs)|75 M allogeneic MPCs by transendocardial injection and mapping.
16289450|NCT00721045|Biological|Mesenchymal Precursor Cells (MPCs)|150 M allogeneic MPCs by transendocardial injection
16289451|NCT00721045|Procedure|standard-of-care treatment with mock mapping and injection procedures.|Mock
16289452|NCT00721045|Procedure|standard-of-care treatment with mock mapping and injection procedures.|Mock
16289453|NCT00721045|Procedure|standard-of-care treatment with mock mapping and injection procedures.|Mock
16289454|NCT00721032|Procedure|MRI guided VT ablation|Magnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia (VT)
16289455|NCT00721032|Drug|Increased dose of amiodarone|"Increase the dose of amiodarone according to the following scheme:
~current dose -> new dose 100 once daily (QD) -> 200 QD; 200 QD -> 400 QD; 300 QD -> 600 QD; 400 QD -> 600 QD"
16289456|NCT00721019|Other|5-hour bedtime|10 days with sleep restricted only to a 5-hour bedtime period at night
16289457|NCT00721019|Other|8.5-hour bedtimes|10 days with sleep allowed only during a 8.5-hour period at night
16289458|NCT00721006|Biological|MESENDO|40 subcutaneous injections of biological product
16289459|NCT00721006|Biological|Placebo|40 subcutaneous injections of placebo
16289460|NCT00720967|Procedure|Open Heart Surgery (OHS)|General anesthesia, use of iodine impregnated adhesive dressing, median sternotomy and/or thoracotomy incision, full heparinization (300-400 ui/kg), arterial and venous cannulation, initialization of CPB with or without aortic cross-clamping and high-potassium cold cardioplegia, surgical repair under mild-moderate hypothermia. De-clamping (if cross clamp was applied), neutralization of heparin by protamin, de-cannulation and hemostasis after surgical repair. Insertion of drain(s) and pacing wire(s). Closure of all layers in anatomical plan.
16289461|NCT00720967|Procedure|Intraoperative Modified Ultrafiltration (MUF)|Once the surgical repair is finished, and CPB will be stopped after aortic declamping. The arterial and venous cannulae will be connected to each other using 3-way connectors and a cardioplegia line. When hemodynamic stability is established (MAP >75 mmHg, CVP > 12 mmHg, Htc > 25%), blood will be drained from the arterial cannula using a roller pump, driven to the ultrafilter, and eventually to the venous cannula. The blood flow will be maintained at ~150 mL/min, and suction will be applied to the filtrate port to achieve an ultrafiltration of 100-120 mL/min. Heat exchanger and bubble trap of the cardioplegia line will be used to maintain the filtered blood at body temperature and to prevent air embolism, respectively. MUF will continue 20 minutes. The filtered volume will be collected.
16289498|NCT00720733|Behavioral|Personal Interview Group|There are 5 weekly sessions which will be approximately one hour long and will consist of personal interview. The interviews will include both quantitative and qualitative questions. Each session will have a separate theme including: Life 1) History; 2) Health History; 3) Personality; 4) Social Networking; and, 5) Meaning & Purpose.
16289499|NCT00720720|Dietary Supplement|plant sterol enriched margarine|Each group will have to consume 20 grams of margarines (either placebo or enriched in plant sterols) in one or two catches per day, for 8 weeks.
16289462|NCT00720967|Procedure|Hemodialysis (HD)|Two HD sessions will be performed at 3 days and 1 day prior to surgery. Each session will last 3 hours if the patient weighs < 75 kg, and 4 hours if > 75 kg. Conventional HD will be carried out using a volume-controlled dialysis machine. A bicarbonate dialysate containing K (3 mmol/L), Ca (1.5 mmol/L) and HCO3 (31 mmol/L) will be used. Sodium conductivity will be set at 138 mmol/L. Medium-flow filters will be used as artificial kidney devices. Dialysate temperature will be set at 36oC. Dialysate and blood flow rate will be set at 500 mL/min and 250-300 ml/min, respectively. Intradialytic ultrafiltration will not be used routinely unless the patient has volume overload. The decision to use intradialytic ultrafiltration will be taken with the anaesthesiologist and the cardiac surgeon. If intradialytic ultrafiltration is indicated, maximal rate of ultrafiltration will be 10 ml/kg/hour. These patients will undergo open heart surgery after two sessions of HD.
16289463|NCT00720954|Procedure|Ct-guided pleural needle biopsy|Biopsy of pleura
16289464|NCT00720954|Procedure|Thoracoscopy|Biopsy of pleura
16289465|NCT00720941|Drug|Pazopanib|800 mg administered once daily orally continuous dosing
16289466|NCT00720941|Drug|Sunitinib|50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
16289467|NCT00720928|Drug|flucinolone acetonide|Intra-vitreal implantation of RETISERT on the study eye. The implant is a sustained-release delivery system containing 0.59 mg of flucinolone acetonide designed to deliver the drug for approximately 3 years.
16289468|NCT00720915|Other|Discontinue anticoagulant therapy (Negative d-dimer)|Patients with negative d-dimer discontinue long-term anticoagulant therapy.
16289469|NCT00720915|Other|Continue on anticoagulant therapy (positive d-dimer)|Patients with positive d-dimer continue or re-start on anticoagulant therapy
16289470|NCT00720902|Procedure|Blood draws|Subjects will have serum cardiovascular markers assessed
16289471|NCT00720902|Drug|Growth hormone releasing hormone (GHRH) and arginine|Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
16289472|NCT00720902|Procedure|Carotid ultrasound|Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
16289473|NCT00720902|Procedure|MRI|Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
16289474|NCT00720902|Procedure|Endothelial cell biopsy|Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.
16289475|NCT00720876|Biological|rituximab|Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
16289476|NCT00720876|Drug|vorinostat|200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
16289477|NCT00720850|Drug|lenalidomide|p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT
16289478|NCT00720837|Procedure|Visualase® Thermal Therapy System|An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.
16289479|NCT00720824|Behavioral|Topical anesthetic and hypnotic distraction|Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.
16289480|NCT00720824|Behavioral|Office routine|Standard vaccine administration
16289481|NCT00720811|Drug|Artemether-lumefantrine combination|20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days
16289482|NCT00720811|Drug|amoxycillin|amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
16289483|NCT00720811|Drug|paracetamol|paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
16289484|NCT00720811|Device|malaria rapid diagnostic test, respiratory rate timer|malaria dipstick, and breath timer
16289485|NCT00720811|Drug|Artemether-lumefantrine combination|20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2
16289486|NCT00720798|Drug|Tocilizumab|For participants weighing > 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
16289487|NCT00720798|Drug|Disease-modifying anti-rheumatic drugs|Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.
16289488|NCT00720798|Drug|Non-steroidal anti-inflammatory drugs|Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.
16289489|NCT00720798|Drug|Oral corticosteroids|Oral corticosteroids (≤ 10 mg/day) were permitted during the study.
16289492|NCT00720772|Drug|25% intravenous (IV) sodium thiosulfate|50 ml IV drip twice/week post hemodialysis
16289493|NCT00720759|Drug|D-cycloserine + distributed treatment|Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
16289494|NCT00720759|Behavioral|D-cycloserine + condensed treatment|Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
16289495|NCT00720759|Drug|Placebo + distributed treatment|Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
16289496|NCT00720759|Behavioral|Placebo + condensed treatment|Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
16289497|NCT00720733|Behavioral|Skills-Building Intervention|A 5-week intervention including 5 weekly sessions covering 8 varied coping skills with daily home practice. The skills are: 1) noting daily positive events; 2) capitalizing on positive events; 3) gratitude; 4) mindfulness; 5) positive reappraisal; 6) focusing on personal strengths; 7) setting and working toward attainable goals; and 8) small acts of kindness. Sessions are 1 hour long and include approximately 30 minutes per day.
16289501|NCT00720707|Procedure|CAF+ADM+EMD|using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).
16289502|NCT00720707|Procedure|CAF+ADM|using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.
16289503|NCT00720694|Device|Duolith SD1|
16289504|NCT00720694|Device|Sham Duolith SD1|
16289505|NCT00720668|Procedure|radiofrequency ablation|radiofrequency ablation for HCC
16289506|NCT00720655|Other|Dietary intervention|Fatty fish at least 4 meals per week.
16289507|NCT00720655|Other|Dietary intervention|Lean fish at least 4 meals per week.
16289508|NCT00720655|Other|Dietary intervention|Control diet with lean meat and chicken.
16289509|NCT00720629|Drug|Visilizumab|3 mg/m^3, IV (in the vein) on day 0, prior to hematopoietic cell infusion (transplant).
16289510|NCT00720629|Drug|Tacrolimus|0.02 mg/kg/24h (based on ideal body weight) continuous infusion (over 24 hours) beginning on day 4 after transplant up to approximately day 180 after transplant. Switch to oral tacrolimus as able. Dose adjusted based on levels. In the absence of GVHD, the dose to be tapered beginning 100 days after transplant.
16289511|NCT00720629|Drug|Methotrexate|15 mg/m^2 intravenously (IV) on Day 1 after transplant; 10 mg/m^2 IV on Days 3, 6 and 11 after transplant.
16289512|NCT00720629|Drug|Antithymocyte globulin (ATG)|1 mg/kg IV over 6 hours on Day 3 before transplant; 3.25 mg/kg IV over 4 hours on days 2 and 1 before transplant.
16289513|NCT00720629|Drug|Tacrolimus|0.03 mg/kg/24h (based on ideal body weight) continuous infusion (over 24 hours) beginning on day 3 before transplant up to approximately day 180 after transplant. Switch to oral tacrolimus as able. Dose adjusted based on levels. In the absence of GVHD, the dose to be tapered beginning 100 days after transplant.
16289514|NCT00720629|Drug|Methotrexate|15 mg/m^2 IV on Day 1 after transplant; 10 mg/m^2 IV on Days 3, 6 and 11 after transplant.
16289515|NCT00720616|Drug|Norditropin|Norditropin 0.1 mg/day self-administered once a day subcutaneously
16289516|NCT00720603|Drug|Plerixafor|Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session
16289517|NCT00720590|Drug|Atazanavir|400 mg of atazanavir (two 200-mg capsules) per day for 4 weeks
16289518|NCT00720590|Drug|Lopinavir/ritonavir|400 mg/100 mg of lopinavir/ritonavir (three soft-gel capsules, each containing 133.3 mg lopinavir and 33.3 mg ritonavir) twice per day with food for 4 weeks
16289519|NCT00720590|Drug|Placebo|Daily dose of placebo for 4 weeks
16289520|NCT00720577|Drug|Simvastatin|40 Mg. tablet, 1 tablet daily
16289521|NCT00720577|Drug|Losartan|50 mg., tablets, 1 tablet once daily
16289522|NCT00720577|Drug|Pioglitazone|30 mg, tablet, 1 tablet once daily
16289523|NCT00720564|Drug|arsenic trioxide|
16289524|NCT00720564|Drug|temozolomide|
16289525|NCT00720564|Procedure|adjuvant therapy|
16289526|NCT00720564|Radiation|intensity-modulated radiation therapy|
16289527|NCT00720564|Radiation|radiation therapy|
16289528|NCT00720551|Other|alcohol|alcohol 0.05%, 0.08% or 0.11% or placebo
16289529|NCT00720538|Drug|Thalidomide|Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.
16289530|NCT00720538|Drug|placebo|placebo capsules
16289531|NCT00720512|Biological|bevacizumab|Given IV
16289532|NCT00720512|Drug|fluorouracil|Given IV
16289533|NCT00720512|Drug|irinotecan hydrochloride|Given IV
16289534|NCT00720512|Drug|leucovorin calcium|Given IV
16289535|NCT00720512|Drug|oxaliplatin|Given IV
16289536|NCT00720499|Drug|BI 1744 CL plus tiotropium bromide|BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
16289537|NCT00720499|Device|Respimat® Inhaler|
16289538|NCT00720486|Behavioral|Juvenile Justice Anger Management (JJAM) for Girls|JJAM will include two 1.5-hour group treatment sessions per week for 8 weeks. JJAM sessions will be manual based and will be designed to help youth develop skills in the following areas: identifying different types of physical and relational aggression, recognizing early warning signs of anger, avoiding anger-provoking situations, managing anger to prevent aggression, solving problems, communicating about anger-related events, and repairing relationships damaged by anger-related behaviors.
16289539|NCT00720486|Behavioral|Treatment as usual|Treatment as usual will include standard activities in the female juvenile justice program.
16289540|NCT00720473|Drug|Lamotrigine|Lamotrigine with dosage range from 25 mg to 200 mg per day.
16289541|NCT00720447|Biological|alemtuzumab|
16289542|NCT00720447|Biological|donor lymphocytes|
16289543|NCT00720447|Drug|carmustine|
16289544|NCT00720447|Drug|cytarabine|
16289545|NCT00720447|Drug|etoposide|
16289546|NCT00720447|Drug|melphalan|
16289547|NCT00720447|Procedure|allogeneic bone marrow transplantation|
16289548|NCT00720447|Procedure|peripheral blood stem cell transplantation|
16289549|NCT00720434|Drug|PF-00868554|500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
16289550|NCT00720434|Drug|PF-00868554|300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
16289551|NCT00720434|Drug|PF-00868554|200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
16289552|NCT00720434|Drug|Placebo|Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
16289553|NCT00720421|Drug|AZD7325|AZD7325 10 mg oral 2 capsules
16289554|NCT00720421|Drug|AZD7325|AZD7325 1 mg oral 2 capsules
16289555|NCT00720421|Drug|AZD7325|AZD7325 Placebo oral 2 capsules
16289556|NCT00720421|Drug|Lorazepam|Lorazepam 1 mg oral 2 tablets
16289557|NCT00720421|Drug|Lorazepam|Lorazepam Placebo oral 2 tablets
16289558|NCT00720408|Drug|Prograf-XL|oral
16289559|NCT00720408|Drug|Prograf|oral
16289560|NCT00720408|Drug|MMF|oral
16289561|NCT00720382|Drug|0.15% azelastine hydrochloride|1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
16289562|NCT00720382|Drug|Mometasone furoate|200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
16289567|NCT00720343|Drug|Placebo|Gelatin Capsule
16289568|NCT00720330|Drug|ropivacaine|10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation
16289569|NCT00720330|Drug|Lidocaine/Ketamine|Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).
16289570|NCT00720330|Other|placebo|placebo
16289571|NCT00720304|Drug|docetaxel|Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
16289572|NCT00720304|Drug|erlotinib hydrochloride|oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
16289573|NCT00720304|Genetic|fluorescence in situ hybridization|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289574|NCT00720304|Genetic|polymerase chain reaction|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289575|NCT00720304|Other|immunoenzyme technique|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289576|NCT00720304|Other|immunohistochemistry staining method|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289577|NCT00720304|Other|laboratory biomarker analysis|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289578|NCT00720304|Other|pharmacological study|Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
16289579|NCT00720304|Procedure|therapeutic conventional surgery|At 6-8 weeks after completion of chemoradiotherapy, patients with N2 or greater cervical lymph node involvement at baseline or with residual disease may undergo surgery.Patients with persistent disease during study therapy undergo salvage surgery 6-12 weeks after completion of chemoradiotherapy.
16289580|NCT00720304|Radiation|intensity-modulated radiation therapy|radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
16289581|NCT00720304|Radiation|radiation therapy|radiotherapy (may be intensity-modulated) once daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
16289582|NCT00720291|Drug|Metronidazole|Patients who are randomly assigned to receive Metronidazole will receive 500 mg po bid Metronidazole for 7 days
16289583|NCT00720291|Drug|Placebo|Patients who are randomly assigned to receive a placebo will receive a placebo pill po bid for 7 days.
16289584|NCT00720278|Drug|0.15% azelastine hydrochloride 1644 mcg daily|0.15% azelastine hydrochloride 1644 mcg daily
16289585|NCT00720278|Drug|0.1% azelastine hydrochloride 1096 mcg daily|0.1% azelastine hydrochloride 1096 mcg daily
16289586|NCT00720278|Drug|Placebo|0 mcg Placebo daily
16289587|NCT00720265|Drug|Prograf|oral
16289588|NCT00720265|Drug|MR4|oral
16289589|NCT00720252|Device|Ultrasound|To measure intratracheal flow volume (and peak velocity) displaced during breathing cycle in premature fetuses.
16289590|NCT00720239|Other|Taliderm wound healing dressing|"Taliderm wound healing dressing will be applied to the wound site as follows depending on assignment to group:
~Control group receives no intervention. Experimental Group 1 (n = 10) will receive TalidermR only one time at the beginning of the treatment phase.
~Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.
~Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase."
16289591|NCT00720226|Drug|Losartan|Losartan 100 mg daily
16289592|NCT00720226|Drug|Placebo|Placebo pill daily
16289593|NCT00720213|Device|Respironics BiPAP autoSV2|Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
16289594|NCT00720213|Device|Respironics BiPAP autoSV3|Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
16289595|NCT00720200|Behavioral|Facilitator-Based intervention|Family Members receiving facilitator-based intervention
16289596|NCT00720200|Behavioral|Usual Care|Family Members receiving usual care/clinical interaction
16289597|NCT00720174|Biological|Cixutumumab|Given IV
16289598|NCT00720174|Drug|Doxorubicin Hydrochloride|Given IV
16289599|NCT00720174|Other|Laboratory Biomarker Analysis|Correlative studies
16289600|NCT00720161|Drug|Metformin|daily 850 mg
16289601|NCT00720161|Drug|placebo|placebo
16289602|NCT00720148|Drug|Sunitinib and Bortezomib|50 mg/m2, IV (in the vein)on day 5 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops
16289603|NCT00720135|Biological|DI-Leu16-IL2 immunocytokine|Given IV
16289604|NCT00720135|Biological|rituximab|Given IV
16289605|NCT00720135|Other|flow cytometry|Correlative studies
16289606|NCT00720135|Other|immunohistochemistry staining method|Correlative studies
16289607|NCT00720135|Other|pharmacological study|Correlative studies
16289608|NCT00720135|Other|laboratory biomarker analysis|Correlative studies
16289609|NCT00720135|Other|enzyme-linked immunosorbent assay|Correlative studies
16289610|NCT00720135|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16289611|NCT00720122|Drug|Recombinant human insulin like growth factor-1 (rhIGF-1)|Twice daily
16289612|NCT00720109|Drug|Asparaginase|Given IT
16289613|NCT00720109|Drug|Cyclophosphamide|Given IV
16289614|NCT00720109|Drug|Cytarabine|Given IT or IV
16289615|NCT00720109|Drug|Dasatinib|Given PO
16289616|NCT00720109|Drug|Daunorubicin Hydrochloride|Given IV
16289617|NCT00720109|Drug|Dexamethasone|Given IV or PO
16289618|NCT00720109|Drug|Etoposide|Given IV
16289619|NCT00720109|Biological|Filgrastim|Given IV or SC
16289620|NCT00720109|Drug|Hydrocortisone Sodium Succinate|Given IT
16289621|NCT00720109|Drug|Ifosfamide|Given IV
16289622|NCT00720109|Other|Laboratory Biomarker Analysis|Correlative studies
16289623|NCT00720109|Drug|Leucovorin Calcium|Given IV or PO
16289624|NCT00720109|Drug|Mercaptopurine|Given PO
16289625|NCT00720109|Drug|Methotrexate|Given IT, PO, or IV
16289626|NCT00720109|Drug|Methylprednisolone|Given IV
16289627|NCT00720109|Drug|Pegaspargase|Given IM
16289628|NCT00720109|Drug|Prednisone|Given PO or IV
16289629|NCT00720109|Radiation|Radiation Therapy|Some patients undergo cranial RT
16289630|NCT00720109|Drug|Vincristine Sulfate|Given IV
16289631|NCT00720096|Drug|Liposomal Doxorubicin|Liposomal Doxorubicin 40 mg/m2 q 28 days
16289632|NCT00720096|Drug|Topotecan|"Topotecan (daily x 5 days of a 21 day cycle)
~Per amendment #15: Topotecan (days 1, 8, 15 of a 28 day cycle)"
16289633|NCT00720083|Drug|cisplatin|Given IV
16289634|NCT00720083|Drug|vandetanib|Given orally
16289635|NCT00720083|Radiation|radiation therapy|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks.
16289636|NCT00720070|Procedure|positron emission tomography/computed tomography|Patients undergo PET/CT scan
16289637|NCT00720070|Procedure|therapeutic conventional surgery|Patients undergo neck dissection
16289638|NCT00720057|Drug|Naproxen Sodium ER (BAYH6689)|Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery
16289639|NCT00720057|Drug|Placebo|Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery
16289640|NCT00720031|Biological|autologous Melan-A/MART-1 specific CTL clones|"By using patients' blood, several million to several billion of Melan-A/MART1 tumor reactive T cell clone(s) will be produced in vitro, then infused to the patient, 3 to 6 months after collecting blood sample. During this production period of the T cell clone, the patient will be treated with deticene at the dose of 250mg/m2/j by IV for 4 days each month.
~After each T cell clone infusion (J1), the patient will receive IFN-α at the dose of 9 M/U 3 times a week for 4 weeks and Interleukin-2 at the dose of 9 M/U from Day 1 to day 5 and from Day 8 to Day 12."
16289641|NCT00720018|Drug|NP101 Sumatriptan Iontophoretic Transdermal Patch|NP101 transdermal patch delivering sumatriptan for 4 hours.
16289642|NCT00720005|Device|Aspheric Acrysof ReSTOR intraocular lens|Bilateral implantation of Aspheric Acrysof ReSTOR
16289643|NCT00719992|Procedure|coronary angiography|effect of level of HS-CRP
16289644|NCT00719979|Behavioral|Behavioral intervention (iCBT + TeleCoach)|TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
16289645|NCT00719979|Behavioral|Internet-based cognitive behavioral therapy (I-CBT)|I-CBT will include access to an interactive Web-based intervention designed to teach and facilitate the use of cognitive behavioral skills. The intervention will last 12 weeks.
16289646|NCT00719979|Behavioral|Treatment as usual / Wait-list control|TAU will include standard treatment from participants' primary care physicians. Participants will be able to choose between TABI and I-CBT treatment options after a 6-week wait-list period.
16289647|NCT00719966|Drug|anastrozole|Patients receive aromatase inhibition therapy.
16289648|NCT00719966|Drug|exemestane|Patients receive aromatase inhibition therapy.
16289649|NCT00719966|Drug|letrozole|Patients receive aromatase inhibition therapy.
16289650|NCT00719966|Procedure|assessment of therapy complications|Endothelial function is measured
16289651|NCT00719953|Dietary Supplement|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
16289652|NCT00719940|Behavioral|Cognitive behavioral therapy|1-15 individual sessions of 50-60 min. to apply 1-15 manualized tinnitus specific cognitive behavioral therapy interventions structured by the tinnitus care disease management program
16289653|NCT00719940|Other|Waiting group|No intervention
16289654|NCT00719927|Behavioral|Comadres Weight Loss Pilot Program|The first condition will consist of women participating with a female friend (comadre), while the second condition will consist of women participating without a support partner.
16289655|NCT00719914|Drug|eptifibatide|Intra-coronary injection, weight based, of eptifibatide.
16289656|NCT00719914|Drug|eptifibatide|Intra-coronary injection, based on weight, of eptifibatide
16289657|NCT00719914|Drug|normal saline|Intra-coronary injection, weight based, of normal saline.
16289658|NCT00719901|Drug|obatoclax mesylate|Given IV
16289659|NCT00719901|Drug|bortezomib|Given IV
16289660|NCT00719901|Other|laboratory biomarker analysis|Correlative studies
16289661|NCT00719888|Drug|Cyclophosphamide|Given IV
16289662|NCT00719888|Drug|Cyclosporine|Given IV and PO
16289663|NCT00719888|Procedure|Double-Unit Umbilical Cord Blood Transplantation|Undergo double-unit UCBT
16289664|NCT00719888|Drug|Fludarabine|Given IV
16289665|NCT00719888|Other|Laboratory Biomarker Analysis|Correlative studies
16289666|NCT00719888|Drug|Mycophenolate Mofetil|Given IV and PO
16289667|NCT00719888|Radiation|Total-Body Irradiation|Undergo high-dose or moderate-intensity TBI
16289668|NCT00719888|Procedure|Umbilical Cord Blood Transplantation|Undergo UCBT
16289669|NCT00719888|Drug|Thiotepa|Given IV
16289670|NCT00719875|Drug|Vorinostat|BID days -7, 1-7 and 15-21, 200 mg
16289671|NCT00719862|Drug|Placebo nasal spray|Placebo
16289672|NCT00719862|Drug|0.15% azelastine hydrochloride Nasal Spray|0.15% azelastine hydrochloride 822 mcg
16289673|NCT00719849|Biological|anti-thymocyte globulin|30mg/Kg Days -6 to -4
16289674|NCT00719849|Drug|cyclophosphamide|50 mg/Kg Day -6
16289675|NCT00719849|Drug|cyclosporine|Patients will receive cyclosporine A (CSA) therapy beginning on Day -3 maintaining a trough level between 250 and 500 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
16289676|NCT00719849|Drug|fludarabine phosphate|40mg/m2 Days -6 to -2
16289677|NCT00719849|Drug|mycophenolate mofetil|1 gram every 8 hours for patients who are ≥ 40 kg. Pediatric patients (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours. Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD.
16289678|NCT00719849|Procedure|umbilical cord blood transplantation|Single or double unit umbilical cord blood transplant
16289679|NCT00719849|Radiation|total body irradiation|200 cGy Day -1
16289680|NCT00719836|Drug|SB1518|SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
16289681|NCT00719823|Drug|Maraviroc|Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.
16289682|NCT00719810|Drug|delafloxacin|300 mg intravenous every 12 hours
16289683|NCT00719810|Drug|delafloxacin|450 mg intravenous every 12 hours
16289684|NCT00719810|Drug|tigecycline|100 mg then 50 mg intravenous tigecycline every 12 hours
16289685|NCT00719797|Biological|bevacizumab|Given IV
16289686|NCT00719797|Drug|fluorouracil|Given IV
16289687|NCT00719797|Drug|irinotecan hydrochloride|Given IV
16289688|NCT00719797|Drug|leucovorin calcium|Given IV
16289689|NCT00719797|Drug|oxaliplatin|Given IV
16289690|NCT00719784|Device|Vibration Response Imaging|Recordings will be then performed using the VRI device (Deep Breeze™, Or Akiva, Israel). Forty-two sensors that are assembled on 2 planar arrays will be placed on subject's back. Each row of 3 sensors is held in place by silicone cups that are coupled to the patient's back by a computer-controlled low vacuum seal.
16289691|NCT00719771|Device|Global® AP™ Total shoulder arthroplasty|Total shoulder arthroplasty
16289692|NCT00719758|Drug|TRK-100STP (BERASUS LA)|oral
16289693|NCT00719758|Drug|AST-120 (Kremezin®)|oral
16289694|NCT00719745|Drug|Prograf|oral
16289695|NCT00719745|Drug|MR4|oral
16289696|NCT00719732|Device|ReSTOR|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
16289697|NCT00719706|Drug|acetyl-l-carnitine PLUS alpha-lipoic acide|1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid.
16289698|NCT00719706|Drug|Placebo|Placebo
16289699|NCT00719693|Drug|ABT-143 ( rosuvastatin calcium and fenofibric acid )|one dose under low-fat meal condition
16289700|NCT00719693|Drug|ABT-143 (rosuvastatin calcium and fenofibric acid )|one dose under fasting meal condition
16289701|NCT00719680|Biological|IgPro20|
16289702|NCT00719667|Other|coronary artery bypass grafting|on pump off pump
16289703|NCT00719602|Drug|Lamivudine|Taken orally twice daily
16289704|NCT00719602|Drug|Lopinavir/Ritonavir|Taken orally twice daily
16289705|NCT00719602|Drug|Nevirapine|Taken orally twice daily
16289706|NCT00719602|Drug|Zidovudine|Taken orally twice daily
16289707|NCT00719576|Biological|autologous cultured chondrocytes on porcine collagen membrane|Implantation via mini-arthrotomy
16289708|NCT00719576|Procedure|Microfracture|Microfracture performed by arthroscopic surgery
16289709|NCT00719563|Drug|American ginseng|Given orally
16289710|NCT00719563|Other|placebo|Given orally
16289711|NCT00719550|Drug|Capecitabine|Administered at 625mg/m2 BID orally every day while on study.
16289712|NCT00719550|Drug|Epirubicin|Administered day 1 of each cycle at 50mg/m2 IV.
16289713|NCT00719550|Drug|AMG 102|Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
16289714|NCT00719550|Drug|Cisplatin|Administered day 1 of each cycle at 60mg/m2 IV.
16289715|NCT00719550|Drug|Placebo|AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
16289716|NCT00719537|Drug|Aspirin|Aspirin 81 mg once a day
16289717|NCT00719537|Drug|Placebo Oral Tablet|Placebo 1 tab Daily
16289718|NCT00719537|Drug|Progesterone|Oral Progesterone 200 mg Twice Daily
16289719|NCT00719524|Drug|OMBRABULIN (AVE8062)|Dose escalation study with combination chemotherapy
16289720|NCT00719511|Drug|Purified allergen dose 1 integrated in a Patch system|Epicutaneous application of a patch
16289721|NCT00719511|Drug|Purified allergen dose 2 integrated in a Patch system|Epicutaneous application of a patch
16289722|NCT00719511|Drug|Purified allergen dose 3 integrated in a Patch system|Epicutaneous application of a patch
16289723|NCT00719511|Drug|Purified allergen integrated in a Patch system|Epicutaneous application of a patch
16289724|NCT00719498|Drug|Epo-alpha|
16289725|NCT00719485|Other|Educational program|Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care
16289767|NCT00719212|Biological|AMG 479|Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
16289768|NCT00719199|Drug|IMO-2055|SC weekly injections
16289769|NCT00719199|Drug|Cetuximab|given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.
16289770|NCT00719199|Drug|FOLFIRI|Given day 1 of each cycle
16289771|NCT00719186|Drug|Clomiphene citrate|Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
16289726|NCT00719472|Drug|Rituximab|During Cycle 1 rituximab was administered at an initial rate of 50 mg/hour. In the absence of infusion toxicity during Cycle 1, the infusion rate was escalated by 50 mg/h increments every 30 minutes to a maximum rate of 400 mg/hour. In case of infusion-related reactions, the infusion was interrupted or the infusion rate reduced. In case of Grade 3/4 infusion reactions, the rituximab infusion was discontinued and medical treatment provided. If the rituximab infusion in Cycle 1 was tolerated without a serious adverse event (AE) or Grade 3/4 infusion-related AE, as judged by the investigator, infusions in Cycle 2 onwards were administered as follows: 20% of the total dose was given over 30 minutes and the remaining 80% of the dose was given over the next 60 minutes, for a total infusion time of 90 minutes. Commercial preparations of rituximab were used.
16289727|NCT00719472|Drug|CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)|Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion.
16289728|NCT00719472|Drug|CVP (cyclophosphamide, vincristine, prednisone)|Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion.
16289729|NCT00719472|Drug|Analgesic/antipyretic and antihistamine drugs|An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.
16289730|NCT00719459|Drug|Iron Sucrose|Venofer 20 mg/mL
16289731|NCT00719459|Drug|Iron Sucrose|Iron sucrose 20 mg/mL
16289732|NCT00719433|Device|robot therapy (ARMin)|therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
16289733|NCT00719433|Other|conventional therapy|physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
16289734|NCT00719420|Drug|Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole)|Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid with or without omeprazole 20 mg bid for 14 days
16289735|NCT00719420|Drug|Clarithromycin, Amoxicillin, Omeprazole|Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
16289736|NCT00719407|Drug|erythropoietin|250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)
16289737|NCT00719394|Drug|GSI 136|
16289738|NCT00719394|Drug|placebo|
16289739|NCT00719381|Drug|Pioglitazone|Treatment of pioglitazone will consist of 15 mg once daily for 28 days followed by 30 mg once daily for 28 days (N=12)
16289740|NCT00719355|Behavioral|Walking with poles|Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
16289741|NCT00719355|Behavioral|Walking exercise|Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
16289742|NCT00719342|Drug|Oxygen + Carbondioxide|Mixture of 92 % oxygen and 8 % carbon dioxide for inhalation
16289743|NCT00719342|Other|full field flickering light at 12.5 Hz|1 minute stimulation with full field flickering light at 12.5 Hz during measurement of vessel diameters and measurement of blood flow.
16289744|NCT00719329|Drug|Chlorhexidine 4.0%|Solution (4.0%, 7.1% CHX-D)
16289745|NCT00719329|Behavioral|Dry Cord Care|Educational messages regarding clean cord care
16289746|NCT00719316|Drug|Aliskiren|Aliskiren 300mg per day for 6 weeks
16289747|NCT00719303|Behavioral|Behavioral Dietary Intervention|Receive dietary intervention
16289748|NCT00719303|Behavioral|Compliance Monitoring|Complete daily fat gram and step diaries
16289749|NCT00719303|Other|Counseling|Undergo face-to-face and telephone counseling
16289750|NCT00719303|Other|Educational Intervention|Receive educational materials
16289751|NCT00719303|Behavioral|Exercise Intervention|Undergo physical activity intervention
16289752|NCT00719303|Other|Laboratory Biomarker Analysis|Correlative studies
16289753|NCT00719303|Other|Quality-of-Life Assessment|Ancillary studies
16289754|NCT00719303|Other|Questionnaire Administration|Ancillary studies
16289755|NCT00719290|Procedure|Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)|Phacoemulsification of the lens with intraocular lens implant
16289756|NCT00719290|Procedure|Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)|Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
16289757|NCT00719277|Device|Sleuth Implantable ECG Monitoring System|The study device provides monitoring only. It cannot provide intervention or treatment.
16289758|NCT00719264|Drug|RAD001(everolimus)|10 mg qd
16289759|NCT00719264|Drug|interferon alfa-2a|dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
16289760|NCT00719264|Drug|bevacizumab|10 mg/kg every 2 weeks
16289761|NCT00719251|Device|High voltage pulsed current|The patient´s wounds were treated for 45 minutes with HVPC three times a week for 16 weeks or until their ulcers closed. The active electrode made of aluminum foil was secured directly over the wound, which previously had been loosely packed with sterile gauze soaked with 0.9% saline solution. The dispersive electrode was placed 5 cms proximal to the wound.The electrical stimulator Intelect 340 stim model (Chattanooga Group) produces a twin peaked pulse and was applied with the following parameters: continuous mode, submotor level, 100 Hz pulse frequency and 100microseconds pulse duration. Prior to the beginning the study the electrical stimulator was calibrated with oscilloscope (Tektronix TDS 1002 model).
16289762|NCT00719251|Device|Low level laser|Wavelenght 633 nm (DMC - Brazil), power 30 mW, continuous, 2 J/cm2 in the edge of the ulcer and 1.5 J/cm2 in the bed, punctual application in direct contact, 3 times a week, 1 every alternate day, for 16 weeks or until the ulcer closed. The laser device was calibrated before each treatment session with a research radiometer (International Light).
16289763|NCT00719251|Other|Standard nursing care|It was based to nursing intervention classification (NIC)46. These interventions were performed by a qualified nurse and included ulcer irrigation with physiological saline, sharp debridement as needed and maintenance of a moist wound environment with appropriate wound dressing. Patients were all educated regarding pressure off loading of the involved foot. All patients received standard wound care seven times a week for 16 weeks or until their ulcers closed.
16289764|NCT00719238|Behavioral|Nutrition plus education|Nutritional instruction in small groups plus education
16289765|NCT00719238|Behavioral|Education only|Educational video and pamphlets
16289766|NCT00719225|Drug|Belatacept|IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
16289908|NCT00718094|Drug|Placebo Oral Tablet|Oral tablet: placebo
16289772|NCT00719186|Drug|Letrozole|Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
16289773|NCT00719173|Drug|aprepitant|Given orally
16289774|NCT00719173|Drug|cyclophosphamide|Given IV
16289775|NCT00719173|Other|placebo|Given orally
16289776|NCT00719160|Drug|esomeprazole|2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet
16289777|NCT00719160|Drug|Placebo|Placebo 20 mg twice a day for 9 days
16289778|NCT00719147|Procedure|MRI|Not performed for study purposes, MRI will be done as part of routine clinical visit. Findings will be used for study.
16289779|NCT00719147|Other|Functional Status and Symptom Questionnaire|Questionnaire
16289780|NCT00719134|Drug|Maxalt|anti-migraine drug
16289781|NCT00719134|Drug|placebo pill|placebo pills
16289782|NCT00719134|Drug|placebo pills|placebo pills
16289783|NCT00719121|Drug|Talarozole|Topical Application (20 mg)
16289784|NCT00719121|Drug|Differin™, 0.1% adapalene gel|Topical Application (20 mg)
16289785|NCT00719108|Biological|Wosulin R|Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
16289786|NCT00719108|Biological|Actrapid|Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
16289787|NCT00719095|Drug|buprenorphine taper followed by naltrexone maintenance|direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial
16289788|NCT00719095|Behavioral|Behavioral therapy|
16289789|NCT00719056|Drug|Teicoplanin|The selected dose was 10mg/kg and it was given intravenously by a catheter inserted under aseptic conditions in a forearm vein within 15 minutes; it was diluted in one 5% glucose solution of a 50 ml final volume
16289790|NCT00719056|Drug|β-lactams or ciprofloxacin|Multiple doses for up to six consecutive days
16289791|NCT00719043|Biological|A/turkey H5N1 vaccine|Administered as an intramuscular (IM) injection
16289792|NCT00719043|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)|Administered as an intramuscular (IM) injection
16289793|NCT00719043|Biological|Placebo|Administered as an intramuscular (IM) injection
16289794|NCT00719030|Dietary Supplement|Pomegranate pill|Pomegranate extract pill
16289795|NCT00719030|Dietary Supplement|Pomegranate pill placebo|Pomegranate pill placebo
16289796|NCT00719017|Procedure|Upper vaginectomy|Laparoscopic surgery with upper vaginectomy
16289797|NCT00719017|Radiation|Post-operative brachytherapy|Laparoscopic surgery followed by brachytherapy
16289798|NCT00719017|Procedure|Standard procedures|Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
16289799|NCT00719004|Procedure|Ultrasound of the foot|These volunteers will have one ultrasound scan of each foot
16289800|NCT00718991|Device|Spectranetics Turbo elite™ excimer laser catheter|The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.
16289801|NCT00718978|Procedure|CSS grafting|grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance
16289802|NCT00718965|Drug|AVE5530|one tablet in the evening with dinner
16289803|NCT00718965|Drug|Placebo|one tablet in the evening with dinner
16289804|NCT00718952|Drug|Vardenafil|vardenafil tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.
16289805|NCT00718952|Drug|Placebo|Placebo tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.
16289806|NCT00718952|Drug|Vardenafil|Patients in all the 2 arms will take vardenafil tablet 5mg twice-daily orally from week 13 to week 24(open-label).
16289807|NCT00718939|Device|Rheos Baroreflex Activation Therapy System|The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.
16289808|NCT00718913|Drug|Docetaxel|Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.
16289809|NCT00718913|Drug|Cisplatin|Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.
16289810|NCT00718913|Drug|Capecitabine|Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).
16289811|NCT00718913|Radiation|Radiation|At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.
16289812|NCT00718913|Drug|Capecitabine|Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).
16289813|NCT00718887|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks
16289814|NCT00718887|Drug|Adefovir/Entecavir|Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks
16289815|NCT00718874|Other|Dietary|modification of macronutrient content
16289816|NCT00718861|Drug|Placebo|
16289817|NCT00718861|Drug|Zoledronic acid|
16289818|NCT00718848|Procedure|Incentre nocturnal hemodialysis|This is a hemodialysis schedule that consists of 3 weekly hemodialysis sessions administered overnight (8 hours/session) in-hospital.
16289819|NCT00718848|Procedure|Remaining on conventional hemodialysis|These patients will remain on their current conventional hemodialysis schedule that consists of 4 hours/session, 3 sessions/week.
16289820|NCT00718835|Behavioral|incentive-based contingency management|Direct comparison of Contingent versus Noncontingent incentives in promoting abstinence from smoking among opioid-treatment patients. The biochemical measures of breath carbon monoxide levels and urinary cotinine are used to confirm smoking status. Participants receive voucher-based incentives either contingent upon demonstrating abstinence from recent smoking (Contingent condition) or independent of smoking status (Noncontingent control condition).
16289821|NCT00718822|Other|oxygen concentration in the culture atmosphere|
16289822|NCT00718809|Drug|saracatinib|Given orally
16289823|NCT00718796|Other|Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise|Individualized according to needs of each participant and willingness to comply. Intervention to include lifestyle modification, dietary changes and supplementation using natural health products as recommended by naturopathic practitioner.
16289824|NCT00718796|Other|Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)|Will vary according to individual - not standardized and likely to include statins.
16289825|NCT00718783|Other|Tissue samples taken from retinoblastoma|Tissue banking
16289826|NCT00718783|Other|5 ml peripheral blood|White blood cells will be isolated from the blood sample as a source of genomic DNA.
16289827|NCT00718770|Drug|Bexarotene|Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
16289828|NCT00718757|Drug|Dexamethasone|5 doses given on Days 6-10
16289829|NCT00718757|Drug|Irinotecan|20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12
16289830|NCT00718757|Drug|Vincristine|"1.5 mg/m2/day IV (max 2 mg), 2 doses given on Days 1,8
~* Patients < 1 year of age or < 10kg in weight: Vincristine 0.05 mg/kg"
16289831|NCT00718744|Other|Standardization of allergenic extract (Ch. arcuatus)|Allergenic extract for cutaneous prick-test
16289832|NCT00718731|Drug|GSI-136|
16289833|NCT00718731|Other|Placebo|
16289834|NCT00718718|Drug|CNTO 136 100 mg|CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
16289835|NCT00718718|Drug|CNTO 136 50 mg|CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
16289836|NCT00718718|Drug|CNTO 136 25 mg|CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
16289837|NCT00718718|Drug|Placebo|Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
16289838|NCT00718718|Drug|Methotrexate|Stable dose of methotrexate will be maintained through Week 24.
16289839|NCT00718705|Drug|Josamycin|josamycin with posology of 2 grams per day by oral way during 10 days
16289840|NCT00718705|Drug|Placebo|Placebo with posology of 2 grams per day by oral way during 10 days
16289841|NCT00718692|Drug|Sym001|Each cohort will receive one single dose of Sym001 according the assigned dose level.
16289842|NCT00718679|Drug|IVN201|Intralymphativ injection of the study drug
16289843|NCT00718679|Drug|Placebo|
16289844|NCT00718666|Biological|Meningococcal vaccine GSK134612|One dose, as intramuscular injection
16289845|NCT00718653|Dietary Supplement|Lutein|Lutein (12 mg/d)
16289846|NCT00718653|Dietary Supplement|Lutein plus green tea extract|lutein (12 mg/d) plus green tea extract (200 mg/d)
16289847|NCT00718640|Drug|Dexamethasone|Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
16289848|NCT00718640|Drug|Bortezomib|Bortezomib 1.3 milligram per meter^2 (mg/m^2), bolus intravenous injection will be administered on Days 1, 4, 8 and 11 of each 21-day cycle and up to 8 cycles.
16289849|NCT00718627|Biological|Human Heterologous Liver Cells|Multiple applications of liver cell suspension for infusion
16289850|NCT00718614|Procedure|Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.|Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
16289851|NCT00718601|Drug|Imetelstat Sodium (GRN163L)|25% dose escalation infused over 2 hours weekly
16289852|NCT00718588|Drug|MTRX1011A|Subcutaneous and intravenous single and repeating dose
16289853|NCT00718575|Procedure|Glucose/Ischemic Preconditioning Pre-treatment|A 20% dextrose+insulin infusion is administered to the liver via the mesenteric vein beginning after cannulation of the mesenteric vein and ending immediately prior to flushing with cold preservation fluid. Also, after completion of the visceral dissection but prior to cross-clamping, ischemic precondition will occur. This involves occluding the portal vein and hepatic artery to stop blood flow for 10 minutes, then restoring blood flow for 10 minutes.
16289854|NCT00718562|Drug|AMN107|
16289855|NCT00718549|Drug|Cladribine|Cladribine will be adminiatered at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4 of each 28-day cycle during induction phase.
16289856|NCT00718549|Drug|Cyclophosphamide|Cyclophosphamide will be administred at a dose of 250 mg/m^2/day as IV infusion over 15-30 minutes on Days 2-4 of each 28-day cycle during induction phase.
16289857|NCT00718549|Drug|Rituximab|Rituximab will be administered at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 during induction phase. Rituximab will be administered at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle during maintenance phase.
16289858|NCT00718536|Drug|Addition of raltegravir 800 mg QD to HAART|Addition of raltegravir 800 mg QD to HAART
16289859|NCT00718523|Drug|AMG 479|Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
16289860|NCT00718523|Drug|AMG 479 Placebo|Matching placebo administered Day 1 of each 21 day cycle.
16289861|NCT00718510|Drug|L-Arginine|3 grams, twice daily, oral administration
16289862|NCT00718484|Drug|Palifosfamide Tris and Doxorubicin|On Day 1 of each cycle (21 days), 150 mg/m2 IV (intravenous) palifosfamide tris and 75 mg/m2 IV doxorubicin are administered on the same day. Doxorubicin administration will be initiated approximately 60 minutes after the completion of palifosfamide tris dosing. Palifosfamide tris alone is administered on Days 2 and 3, every 3 weeks (one 21-day cycle).
16289987|NCT00717470|Drug|Advagraf®|oral
16289863|NCT00718484|Drug|Doxorubicin|On Day 1 of each cycle, 75 mg/m2 doxorubicin is administered IV.
16289864|NCT00718471|Drug|Enoxaparin|ENOXAPARIN IV 0.5 mg.kg
16289865|NCT00718471|Drug|UFH (unfractionated heparin)|UFH IV 50-70 IU if GP IIbIIIa or 70-100IU if no GP IIbIIIa
16289866|NCT00718432|Behavioral|Exercise and nutritional integrated care|Besides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions.
16289867|NCT00718432|Behavioral|Usual care with education|The study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments.
16289868|NCT00718432|Behavioral|Problem solving therapy (PST) integrated care|Besides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements.
16289869|NCT00718419|Drug|Enzastaurin|"Enzastaurin: Cycle 1 Day 1 only: 3, 125-milligrams (mg) tablets three times on Day 1 (Day 1 total dose = 1125 mg)
~Day 2 onwards and subsequent Cycles: 2, 125-mg tablets orally twice a day (500 mg total per day).
~Cycle length (all cycles): 28 days. Patients may stay on drug past 8 cycles, (until the study is closed) or until disease progression."
16289870|NCT00718406|Drug|Metoprolol|
16289871|NCT00718406|Drug|metoprolol plus morphine|
16289872|NCT00718380|Drug|ABT-869|2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
16289873|NCT00718354|Drug|Enoxaparin|Once daily dose of 1mg/Kg of body weight for 6 months
16289874|NCT00718354|Drug|Standard Chemotherapy|Investigator's discretion
16289875|NCT00718341|Drug|AF056|
16289876|NCT00718341|Drug|Placebo|
16289877|NCT00718328|Drug|Simvastatin 80 mg|Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
16289878|NCT00718328|Drug|Placebo|Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
16289879|NCT00718315|Drug|erlotinib [Tarceva]|150mg po daily
16289880|NCT00718315|Drug|fusidic acid [Verutex]|topical, daily for 30 days.
16289881|NCT00718315|Drug|erythromycin [Eritex]|topical, daily for 30 days.
16289882|NCT00718315|Drug|Fisiogel|topical, daily for 30 days
16289883|NCT00718302|Device|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
16289884|NCT00718302|Device|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
16289885|NCT00718289|Other|Citrate dialysate|dialysis fluid composition for Citrate (C) and Acetate (A): acetate [3.0 mmol/L in A and 0.3 in C], citrate [0 mmol/L in A and 0.8 in C]
16289886|NCT00718289|Other|Acetate dialysate|dialysis fluid composition for Citrate (C) and Acetate (A): acetate [3.0 mmol/L in A and 0.3 in C], citrate [0 mmol/L in A and 0.8 in C]
16289887|NCT00718276|Drug|25(OH)D|daily (20ug), weekly (140 ug), Bolus (140 ug)
16289888|NCT00718276|Dietary Supplement|vitamin D3|daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
16289889|NCT00718250|Biological|RFUSIN2-AML1|AML cell vaccine alone. x4 doses 3 weeks apart
16289890|NCT00718250|Biological|Donor leukocyte infusion (DLI)|1 dose 1x107/kg
16289891|NCT00718250|Biological|RFUSIN2-AML1 and donor leukocyte infusion|AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
16289892|NCT00718250|Biological|RFUSIN2-AML1 and donor leukocyte infusion|AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
16289893|NCT00718237|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)|Rotateq orally administered 3 times
16289894|NCT00718237|Biological|Comparator: Comparator: Placebo (unspecified)|Placebo orally administered 3 times
16289895|NCT00718224|Drug|Semuloparin sodium|"0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe
~Subcutaneous injection"
16289896|NCT00718224|Drug|Enoxaparin|"0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe
~Subcutaneous injection"
16289897|NCT00718224|Drug|Placebo|"0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component
~Subcutaneous injection"
16289898|NCT00718185|Procedure|Obtain blood specimens|Obtain blood samples at multiple timepoints.
16289899|NCT00718172|Procedure|Liver Biopsy|
16289900|NCT00718172|Drug|Peginterferon &amp; Ribavirin for Hepatitis C|
16289901|NCT00718172|Drug|Pre-treatment Ribavirin|
16289902|NCT00718159|Drug|LY573636-sodium|Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Dosing will be done on Day 1 of a 35-day cycle for acute myeloid leukemia (AML) and Day 1 of a 28-day cycle for essential thrombocythemia (ET) for at least one cycle. A participant may have additional cycles of LY573636 if he or she is receiving benefit from the study drug and does not fulfill any of the criteria for study discontinuation.
16289903|NCT00718146|Biological|Split virion, inactivated Influenza vaccine|0.5 mL, Intramuscular (IM)
16289904|NCT00718146|Biological|Split virion, inactivated Influenza vaccine|0.5 mL, Intramuscular (IM)
16289905|NCT00718133|Device|Spirometry (Pony spirometer)|Spirometry at rest
16289906|NCT00718120|Biological|Fluviral®|One intramuscular injection into the deltoid region of the non-dominant arm
16289907|NCT00718094|Drug|Polyphenon E®|Oral capsules
16289909|NCT00718081|Drug|Oral sufentanil|Oral dosage of sufentanil
16289910|NCT00718081|Drug|Placebo|Oral dosage of placebo
16289911|NCT00718068|Drug|Sterile Potassium Chloride Concentrate|Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly
16289912|NCT00718068|Drug|Sterile Potassium Chloride Concentrate|By intermittent infusion, 20mmol diluted in 100ml 0.9% NaCl, administered over 60 mins, serum potassium level checked 2 hourly, and repeat doses administered as appropriate
16289913|NCT00718042|Device|ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay|Test blood donor sample with ABBOTT PRISM Chagas assay. If results are reactive, donor sample will be tested with Chagas Confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
16289914|NCT00718042|Device|ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay|Test blood donor sample with investigational Chagas assay. If results are reactive, donor samples will be tested with Chagas confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
16289915|NCT00717990|Drug|Capecitabine|Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
16289916|NCT00717990|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
16289917|NCT00717990|Drug|Irinotecan|Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
16289918|NCT00717977|Device|Continuous glucose monitor|Daily use of a continuous glucose monitor for 3-7 days
16289919|NCT00717951|Drug|docetaxol, cisplatin, capecitabine|docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)
16289920|NCT00717938|Drug|cisplatinum or carboplatin and e.g.etoposide.|Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. Treatment will be given every three weeks for 4-6 cycles according to local variants.
16289921|NCT00717938|Drug|cisplatinum or carboplatin and e.g.etoposide+enoxaparin|Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.
16289922|NCT00717925|Drug|Inotuzumab Ozogamicin (CMC-544)|Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
16289923|NCT00717912|Other|Experimental sweetener syrup|3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
16289924|NCT00717912|Other|Classical sweetener syrup|1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
16289925|NCT00717912|Other|Classical sugar syrup|3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
16289926|NCT00717899|Device|Spirometry (Pony spirometer)|Spirometry at rest
16289927|NCT00717886|Radiation|isosulfan blue dye|"At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies day of mapping for patient convenience."
16289928|NCT00717873|Device|Airway clearance Device|Provided by the Vest Airway clearance system
16289929|NCT00717860|Drug|caspofungin acetate|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
16289930|NCT00717860|Drug|Comparator: Micafungin sodium|Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
16289931|NCT00717834|Biological|Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant|Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
16289932|NCT00717821|Drug|Methoxy Polyethylene Glycol-epoetin Beta|Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
16289933|NCT00717821|Drug|Epoetin Beta|Participants who are receiving SC or IV epoetin beta will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
16289934|NCT00717821|Drug|Darbepoetin Alfa|Participants who are receiving SC or IV darbepoetin alfa will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
16289935|NCT00717808|Drug|Tranilast|Tranilast (300mg twice a day) for a period of seven days whilst taking their weekly prescribed dose of methotrexate. Followed by a 7 day washout period before starting arm 2
16289936|NCT00717808|Drug|Placebo comparator|The patient will receive the placebo capsule twice a day whilst receiving their weekly dose of methotrexate
16289937|NCT00717795|Behavioral|interview and physical activity|For Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline).
16289938|NCT00717795|Behavioral|interview and wait list|Participants in the control condition (Arm 2)will be assessed at baseline and 12 weeks post baseline (Follow-up). At this time, the PA intervention will be offered at no cost to the participants in the control condition. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.
16289939|NCT00717782|Procedure|injection of botulinum toxin|Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter
16289940|NCT00717782|Procedure|injection of saline|Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter
16289941|NCT00717769|Drug|SUN13834|Low dose, orally 3 times a day (tid) for 28 days of SUN13834
16289942|NCT00717769|Drug|Placebo|Placebo, orally (tid) for 28 days of SUN13834
16289943|NCT00717756|Drug|lenalidomide|25 mg po qd x 21 days then 1 week off equals one cycle
16289944|NCT00717730|Dietary Supplement|Folic Acid|150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months.
16289945|NCT00717730|Dietary Supplement|Vitamin B12|1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.
16289946|NCT00717730|Dietary Supplement|Placebo|Placebo with no active ingredients
16289947|NCT00717730|Dietary Supplement|Folic acid and vitamin B12|Folic acid 150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months vitamin B12 1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.
16289948|NCT00717717|Behavioral|Intervention|One-year rehabilitation program including weekly supervised and group-based physical exercise, home-based physical activity, individual and group-based coaching (narrative therapy), and expert educational talks/lectures
16289949|NCT00717704|Drug|ixabepilone|by vein once every 3 weeks
16289950|NCT00717704|Drug|Dasatinib|by mouth once daily
16289951|NCT00717691|Device|Metatarsophalangeal Extension Dynasplint System|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.
16289952|NCT00717691|Other|Standard of Care|The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
16289953|NCT00717678|Drug|Prograf-XL|oral
16289954|NCT00717678|Drug|Prograf|oral
16289955|NCT00717678|Drug|MMF|oral
16289956|NCT00717665|Device|Home blood pressure tele-management system.|Scheduled blood pressure monitoring with transmission of information to a central server for processing and disbursement.
16289957|NCT00717665|Other|Usual care.|Patient self-monitoring of blood pressure with results taken by patient to the doctor at scheduled visits.
16289958|NCT00717652|Drug|arbutin, tretinoin, triamcinolone|arbutin, tretinoin, triamcinolone
16289959|NCT00717652|Drug|Triluma|Hydroquinone, Fluoncinolone, Tretinoin
16289960|NCT00717639|Procedure|Diagnostic MR-Angiography|Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist
16289961|NCT00717626|Drug|Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS|Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.
16289962|NCT00717600|Dietary Supplement|Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1|2x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule.
16289963|NCT00717587|Drug|motexafin gadolinium|
16289964|NCT00717587|Drug|sunitinib malate|
16289965|NCT00717587|Genetic|comparative genomic hybridization|
16289966|NCT00717587|Genetic|gene expression analysis|
16289967|NCT00717587|Genetic|mutation analysis|
16289968|NCT00717587|Genetic|polymorphism analysis|
16289969|NCT00717587|Other|immunohistochemistry staining method|
16289970|NCT00717587|Other|iodine I-124 girentuximab|
16289971|NCT00717587|Other|laboratory biomarker analysis|
16289972|NCT00717587|Other|pharmacological study|
16289973|NCT00717587|Procedure|adjuvant therapy|
16289974|NCT00717587|Procedure|neoadjuvant therapy|
16289975|NCT00717587|Procedure|therapeutic conventional surgery|
16289976|NCT00717574|Drug|Sevoflurane group|Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
16289977|NCT00717574|Drug|Propofol group|Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
16289978|NCT00717561|Drug|Avelox (Moxifloxacin, BAY12-8039)|IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours
16289979|NCT00717561|Drug|Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin|IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.
16289980|NCT00717548|Behavioral|Narrative Exposure Therapy|Trauma-Focused short term intervention (8-12 sessions)
16289981|NCT00717535|Other|cryopreservation|
16289982|NCT00717535|Other|questionnaire administration|
16289983|NCT00717535|Other|study of socioeconomic and demographic variables|
16289984|NCT00717522|Drug|Pomalidomide|
16289985|NCT00717496|Other|Telephone Support Intervention to Improve Breastfeeding|The intervention will consist of outreach telephone calls daily by bilingual trained nursing staff for the first 2 weeks postpartum using the scripted protocols developed for this program. Both groups will receive a small bag with reading materials, illustrations of breastfeeding positions and latch, hand breast pump, and lanolin cream. The intervention nurse will ask the mothers on their initial intake call for the best time to call each day to minimize time needed to reach the mother.
16289986|NCT00717470|Drug|Prograf®|oral
16289988|NCT00717470|Drug|Mycophenolate Mofetil|oral
16289989|NCT00717470|Drug|Simulect|oral
16289990|NCT00717470|Drug|methylprednisolone / prednisone|oral
16289991|NCT00717457|Drug|exenatide|5mg twice daily for 4 weeks followed by 10mg twice daily
16289992|NCT00717457|Drug|taspoglutide|10mg once weekly
16289993|NCT00717457|Drug|taspoglutide|10mg once weekly for 4 weeks followed by 20mg once weekly
16289994|NCT00717444|Behavioral|contingency management|"contingency management for abstinence plus 12-step facilitation therapy
~prizes awarded for target behaviors"
16289995|NCT00717444|Behavioral|contingency management|"contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities
~prizes awarded for target behaviors"
16289996|NCT00717431|Procedure|Hippocampal Electrical Stimulation|Surgical Implantation of electrode and stimulator
16289997|NCT00717418|Drug|cyclosporine ophthalmic emulsion 0.05%, artificial tears|one drop, twice a day in each eye
16289998|NCT00717405|Drug|Standard chemotherapy|As prescribed
16289999|NCT00717405|Drug|bevacizumab [Avastin]|15mg/kg iv 3 weekly in cycles 1-8
16290000|NCT00717405|Drug|trastuzumab [Herceptin]|8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.
16290001|NCT00717379|Drug|Tacrolimus|oral
16290002|NCT00717379|Drug|Mycophenolate Mofetil|oral
16290003|NCT00717379|Drug|Methylprednisolone or equivalent|oral
16290004|NCT00717379|Drug|Prednisone|oral
16290005|NCT00717366|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|Will be administered IV, every 4 weeks.
16290006|NCT00717340|Drug|tivozanib (AV-951) + paclitaxel|"Tivozanib (AV-951):
~Subjects in the Phase 1b study will receive 1 dose of tivozanib (AV-951) on Day -5 (± 2 days) for PK sampling prior to Cycle 1 only.
~Thereafter in the Phase 1b and 2a study, subjects will receive tivozanib (AV-951) once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment (1 cycle = 4 weeks). On days when paclitaxel and tivozanib (AV-951) are co-administered, AV-951 will be administered immediately following the end of the paclitaxel infusion.
~Paclitaxel: Phase 1b study and Phase 2a study:
~All subjects will receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off (1 cycle = 4 weeks)."
16290007|NCT00717327|Other|Counseling for subjects who do not know their medications|Physician interviewer will provide counseling to subjects who indicate through answers that they do not know their medication names.
16290008|NCT00717314|Drug|Mycophenolate mofetil|1.5 to 2.0 g daily PO BID
16290009|NCT00717314|Drug|CNI (50%)|50% reduction from BL
16290010|NCT00717314|Drug|CNI (≥75%)|≥75% reduction from BL
16290011|NCT00717288|Drug|Detemir|Detemir dosed at 50% of calculated basal insulin infusion requirements
16290012|NCT00717288|Drug|Detemir|Detemir dosed at 65% of calculated basal insulin infusion requirements
16290013|NCT00717288|Drug|Detemir|Detemir dosed at 80% of calculated basal insulin infusion requirements
16290014|NCT00717275|Drug|Temozolomide|75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.
16290015|NCT00717262|Drug|HQK-1001|HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.
16290016|NCT00717262|Drug|placebo|Matching placebo capsules administered once a day, orally, for 14 days.
16290017|NCT00717249|Device|galyifilcon A control lens|Marketed daily wear contact lens
16290018|NCT00717249|Device|galyfilcon A with a silver additive|Investigational daily wear contact lens
16290019|NCT00717236|Drug|Certolizumab pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
16290020|NCT00717236|Other|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
16290021|NCT00717210|Drug|Temozolomide|200 mg/m2 body surface on days 1-5 every 28 days for 8 cycles; and again for another 4 cycles at primary progression
16290022|NCT00717210|Radiation|Focal radiotherapy|54-60 Gy in 28-30 fractions over 6-7 weeks
16290023|NCT00717197|Drug|Capecitabine|1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
16290024|NCT00717184|Drug|Interleukin, NK cells|
16290025|NCT00717171|Device|SurgiStim3|Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42.
16290026|NCT00717171|Device|SurgiStim3|The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down).
16290027|NCT00717158|Behavioral|Usual medical care|
16290028|NCT00717158|Behavioral|Lifestyle Case management|Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
16290029|NCT00717145|Drug|risedronate|one risedronate 20 mg DR tablet
16290030|NCT00717145|Drug|risedronate|One risedronate 20 mg DR tablet
16290031|NCT00717145|Drug|risedronate|One risedronate 35 mg DR tablet
16290032|NCT00717145|Drug|risedronate|One risedronate 35 mg IR tablet
16290033|NCT00717132|Behavioral|Individual Behavior Modification|Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.
16290034|NCT00717132|Behavioral|Family-based behavior modification|Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.
16290209|NCT00715780|Drug|insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16291820|NCT00703664|Other|Laboratory Biomarker Analysis|Correlative studies
16290035|NCT00717093|Drug|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
16290036|NCT00717093|Drug|Placebo|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
16290037|NCT00717080|Procedure|IOL surgery|IOL surgery using capsular tension ring (AURORING)
16290038|NCT00717080|Procedure|IOL surgery|IOL surgery without CTR
16290039|NCT00717067|Drug|Maraviroc|Maraviroc 300 mg (150 mg x 2 tablets) x single dose
16290040|NCT00717067|Drug|Maraviroc|Maraviroc 150 mg tablet twice daily x 7 days
16290041|NCT00717067|Drug|Ritonavir|Ritonavir 100 mg capsule twice daily x 7 days
16290042|NCT00717067|Drug|Saquinavir|Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
16290043|NCT00717067|Drug|Maraviroc|Maraviroc 150 mg tablet once daily x 7 days
16290044|NCT00717067|Drug|Ritonavir|Ritonavir 100 mg capsule twice daily x 7 days
16290045|NCT00717067|Drug|Saquinavir|Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
16290046|NCT00717067|Drug|Maraviroc|Maraviroc 150 mg tablet once every 48 hours x 7 days
16290047|NCT00717067|Drug|Ritonavir|Ritonavir 100 mg capsule twice daily x 7 days
16290048|NCT00717067|Drug|Saquinavir|Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days
16290049|NCT00717067|Drug|Maraviroc|Maraviroc 300 mg (150 mg x 2 tablets) x single dose
16290050|NCT00717067|Drug|Maraviroc|Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis
16290051|NCT00717067|Drug|Maraviroc|Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
16290052|NCT00717054|Drug|Aprepitant|Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
16290053|NCT00717054|Drug|Scopolamine|Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
16290054|NCT00716989|Biological|Tuberculin antigen|2 intradermal injection of 50µl of antigen + 2 intradermal injection of 50µl of physiological serum
16290055|NCT00716976|Drug|sodium thiosulfate|Given IV
16290056|NCT00716976|Procedure|examination|Patients undergo audiological assessments periodically
16290057|NCT00716963|Drug|Fluticasone propionate (Flovent Diskus) 250 mcg|Flovent Diskus 250 mcg
16290058|NCT00716963|Drug|budesonide 400 mcg|budesonide 400 mcg
16290059|NCT00716963|Other|Placebo|Placebo
16290060|NCT00716950|Drug|valsartan/amlodpine|tablets; 160mg/5mg; od; 4 weeks
16290061|NCT00716950|Drug|losartan/amlodpine|tablets; 100mg/5mg; od; 4 weeks
16290062|NCT00716937|Procedure|karydakis flap|Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft
16290063|NCT00716937|Procedure|laying open|laying open the site of excision of sinus or cyst without any flap
16290064|NCT00716924|Drug|Clopidogrel|300 mg
16290065|NCT00716924|Drug|Clopidogrel|600 mg
16290066|NCT00716911|Drug|ganciclovir|
16290067|NCT00716911|Genetic|polymerase chain reaction|
16290068|NCT00716911|Other|flow cytometry|
16290069|NCT00716911|Other|immunologic technique|
16290070|NCT00716911|Procedure|allogeneic bone marrow transplantation|
16290071|NCT00716911|Procedure|allogeneic hematopoietic stem cell transplantation|
16290072|NCT00716911|Procedure|assessment of therapy complications|
16290073|NCT00716911|Procedure|peripheral blood stem cell transplantation|
16290074|NCT00716872|Behavioral|Sleep Healthy Using the Internet (SHUTi)|"SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I). Users complete daily online sleep diaries in addition to receiving weekly access to six interactive Cores of information. As they progress through the program, users receive tailored instructions for how to improve their sleep."
16290075|NCT00716872|Behavioral|Hypnosis recordings|Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
16290076|NCT00716859|Drug|Timolol|Timolol 0.5% dosed twice-daily
16290077|NCT00716859|Drug|latanoprost|Latanoprost 0.005% ophthalmic solution dosed once-daily
16290078|NCT00716846|Drug|simvastatin|10mg, 2 weeks
16290079|NCT00716846|Drug|atorvastatin|10mg
16290080|NCT00716846|Drug|pitavastatin|2mg
16290081|NCT00716833|Drug|Etoricoxibe|Preemptive group patients get Etoricoxibe either twice (before and after surgery) or just a single preoperative dose.
16290082|NCT00716833|Drug|Placebo|Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery (so called 2x2 factorial study design).
16290083|NCT00716820|Drug|SUNITINIB MALATE|"SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.
~The dosage may be decreased according to the patient's clinical condition."
16290084|NCT00716807|Drug|nalbuphine plus naloxone|Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
16290085|NCT00716807|Drug|nalbuphine plus placebo|Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
16290086|NCT00716807|Drug|nalbuphine plus naloxone|Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
16290087|NCT00716807|Drug|nalbuphine plus placebo|Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
16290088|NCT00716794|Drug|HE3235|HE3235 will be administered orally in 28 day cycles.
16290089|NCT00716768|Procedure|Laparoscopic Inguinal Hernia Repair|Laparoscopic Inguinal Hernia Repair
16290090|NCT00716768|Procedure|Open Inguinal Hernia Repair|Open Inguinal Hernia Repair
16290091|NCT00716755|Drug|Risperidone/Olanzapine and PET scans|Current risperidone/olanzapine users who are 50 or older will be recruited. Dopamine D2 dopamine receptors using a selective D2 dopamine receptor ligand, [11C]-raclopride, and plasma levels of risperidone and 9-OH-risperidone, or of olanzapine, and prolactin will be measured on the 1st PET visit. Subsequently, there will be gradual dose reductions of risperidone or olanzapine by 0.5 and 2.5 mg per week, respectively (as long as the total reduction does not exceed 40%). At least 5 days after the termination of the dose taper, participants will have the second PET scan. Participants will be followed up for 24 weeks after the termination of the dose reduction.
16290092|NCT00716742|Drug|bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%|1 drop in eye(s) every evening
16290093|NCT00716716|Drug|rFIXFc|As specified in the treatment arm
16290094|NCT00716703|Other|CT Scan using IV contrast alone|CT scan using IV contrast alone
16290095|NCT00716690|Procedure|Multi donor stem cell transplantation|stem cell transplantation from 2 donors
16290096|NCT00716664|Other|A treatment series of gentle joint and muscle movements|Undertaken by a physiotherapist, weekly, for six weeks
16290097|NCT00716664|Other|Control group measurements|The control group are measured using the same outcome measures at the same time intervals, but receive no active intervention
16290098|NCT00716651|Drug|mepolizumab|750 mg mepolizumab iv q4wk until week 32
16290099|NCT00716638|Behavioral|Trauma-focused Cognitive Behavior Therapy|This intervention comprises 10 sessions of trauma-focused cognitive behavior therapy for PTSD with the components (a) prolonged imaginal exposure, (b) in vivo exposure, and (c) cognitive restructuring.
16290100|NCT00716638|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR)|This intervention comprises 10 sessions of EMDR according to the standard protocol.
16290101|NCT00716625|Drug|sunitinib malate|"SUTENT® Capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.
~The dosage may be decreased according to the patient's clinical condition."
16290102|NCT00716612|Drug|Coenzyme Q 10|PO Coenzyme Q 10 120 mg QD
16290103|NCT00716612|Drug|Placebo control|po Placebo QD
16290104|NCT00716599|Device|training in use of rapid diagnostic tests (RDTs) for malaria|training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers
16290106|NCT00716573|Drug|everolimus|0,75 mg bid, 24 months
16290107|NCT00716547|Drug|ketoprofen in Diractin®|50 mg (b.i.d.)
16290108|NCT00716547|Drug|ketoprofen in Diractin®|100 mg (b.i.d.)
16290109|NCT00716547|Drug|Placebo|b.i.d.
16290110|NCT00716547|Drug|celecoxib|100 mg (b.i.d.)
16290111|NCT00716534|Drug|ABT-869|12.5 mg ABT-869
16290112|NCT00716534|Drug|Placebo for ABT-869|Placebo Comparator (12.5 mg or 7.5 mg)
16290113|NCT00716534|Drug|ABT-869|7.5 mg ABT-869
16290114|NCT00716534|Drug|Carboplatin|Carboplatin (AUC 6 mg/mL/min)
16290115|NCT00716534|Drug|Paclitaxel|Paclitaxel (200 mg/m2)
16290116|NCT00716521|Drug|placebo|single oral dose placebo
16290117|NCT00716521|Drug|zolpidem|single oral dose, 5 mg zolpidem
16290118|NCT00716521|Drug|zolpidem|single oral dose, 10 mg zolpidem
16290119|NCT00716508|Procedure|Repair with transpatellar tunnels|Repair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella. Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture. Three to four drill holes will then be made through the patella. Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole. The knee will be flexed to 45 degrees. The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella.
16290120|NCT00716508|Procedure|Repair with suture anchors.|Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery. The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics. Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface. Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner.
16290121|NCT00716495|Biological|AGI-101H Vaccine|Each patient will receive one dose of AGI - 101H containing 5 x 107 viable cells, administered s.c. for up to 26 weeks.
16290122|NCT00716469|Drug|LS11|LS11 will be given as a one-time IV infusion over 3-5 minutes.
16290123|NCT00716456|Drug|erlotinib with cetuximab|The phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV every 2 weeks. Patients will have baseline CT, labs and ECG done within 2 weeks of study entry. Three patients will be enrolled per dose level. Patients will be monitored for toxicity weekly for the first 5 weeks, and every 2 weeks thereafter. Patients will be monitored for response by CT in the fourth week of combined therapy and every 8 weeks. All patients in this portion of the trial will receive intravenous cetuximab every two weeks at the MTD (to be determined in phase I portion) and daily erlotinib on an outpatient basis and will obtain clinical re-evaluation and radiographic re-imaging on a schedule similar to that followed in the phase I portion
16290124|NCT00716443|Drug|tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)|Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections
16290125|NCT00716443|Drug|benzocaine 20% / lidocaine 6% / tetracaine 4% ointment|apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
16290126|NCT00716430|Behavioral|Quality Improvement Programme|Quality Improvement training programme
16290127|NCT00716417|Drug|BIBW 2992|In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation.
16290128|NCT00716417|Drug|BIBW 2992|low to high dose, daily
16290129|NCT00716404|Device|Targeted Renal Therapy|Patient diagnosis, treatment, and follow-up are left to the discretion of the participating investigator. There are no requisites as to how patients should be managed as this is intended to be an observational study. No procedures other than usage of the Benephit Infusion System per its Instructions for Use are specifically required for participation in this study.
16290130|NCT00716391|Other|TPF, radiotherapy and cisplatin.|3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days
16290131|NCT00716391|Other|TPF, radiotherapy and cetuximab.|3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
16290132|NCT00716378|Behavioral|Teen Passenger Presence|
16290133|NCT00716365|Device|HemCon bandage|5 cm X 5 cm
16290134|NCT00716352|Behavioral|Educational intervention programme|
16290135|NCT00716339|Behavioral|motivation|
16290136|NCT00716326|Device|Transcutaneous Nerve Stimulation (TENS)|Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months.
16290137|NCT00716326|Device|Cefar Primo Pro TENS device|"Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises.
~Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold."
16290138|NCT00716274|Drug|Atomoxetine|Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
16290139|NCT00716274|Drug|Placebo|oral, daily, for 16 weeks
16290140|NCT00716261|Device|McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes|Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks
16290141|NCT00716248|Drug|bucillamine|bucillamine 100 mg, twice a day
16290142|NCT00716248|Drug|methotrexate|methotrexate 6 mg or more per week
16290143|NCT00716183|Biological|Lactobacillus salivarius HN6|9 log colony-forming units, capsules, daily, four weeks
16290144|NCT00716183|Biological|Lactobacillus reuteri CR20|9 log colony-forming units, capsules, daily, four weeks
16290145|NCT00716183|Biological|Lactobacillus fermentum LC40|9 log colony-forming units, capsules, daily, four weeks
16290146|NCT00716183|Drug|Beta-lactam antibiotic|Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis)
16290147|NCT00716170|Biological|Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon-like peptide-2 (GLP-2)|"Day A: Oral glucose tolerance test (50g glucose)
~Day B: Isoglycemic intravenous (iv) glucose infusion
~Day C: Isoglycemic iv glucose infusion + iv GIP infusion (0-20 min: 4 pmol/kg body weight/min; 20-50 min: 2 pmol/kg body weight/min)
~Day D: Isoglycemic iv glucose infusion + iv GLP-1 infusion (0-20 min: 0,6 pmol/kg body weight/min; 20-50 min: 0,3 pmol/kg body weight/min)
~Day E: Isoglycemic iv glucose infusion + iv GLP-2 infusion (0-20 min: 1 pmol/kg body weight/min; 20-50 min: 0,5 pmol/kg body wight/min)
~Day F: Isoglycemic iv glucose infusion + iv infusion of GIP, GLP-1 and GLP-2 in doses as Day C, D and E."
16290148|NCT00716144|Drug|Talarozole|Oral Capsule Once Daily
16290149|NCT00716105|Other|Standard infant formula|From 3 to 12 months of age. As per standard requirement
16290150|NCT00716105|Other|Infant formula with different level of proteins|From 3 to 12 months of age. As per standard requirement
16290151|NCT00716092|Drug|Placebo (linagliptin)|once daily for 28 days
16290152|NCT00716092|Drug|Placebo (linagliptin)|once daily for 28 days
16290153|NCT00716092|Drug|Sitagliptin|100 mg once daily for 28 days
16290154|NCT00716092|Drug|Placebo (sitagliptin)|once daily for 28 days
16290155|NCT00716092|Drug|Placebo (sitagliptin)|once daily for 28 days
16290156|NCT00716092|Drug|Linagliptin|5mg once daily for 28 days
16290157|NCT00716079|Other|Blood pressure management policies|The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
16290158|NCT00716066|Biological|Anti-Thymocyte Globulin|Given IV
16290159|NCT00716066|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous or syngeneic peripheral blood stem cell transplantation
16290160|NCT00716066|Drug|Carmustine|Given IV
16290161|NCT00716066|Drug|Cytarabine|Given IV
16290162|NCT00716066|Drug|Etoposide|Given IV
16290163|NCT00716066|Other|Laboratory Biomarker Analysis|Correlative studies
16290164|NCT00716066|Drug|Melphalan|Given IV
16290165|NCT00716066|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous or syngeneic peripheral blood stem cell transplantation
16290166|NCT00716066|Drug|Prednisone|Given PO
16290167|NCT00716066|Procedure|Syngeneic Bone Marrow Transplantation|Undergo syngeneic bone marrow transplantation
16290168|NCT00716053|Drug|BLVR|BLVR 20 mL
16290169|NCT00716040|Behavioral|Social-psycho intervention to improve adherence to HAART|The intervention focus on the notion of scenes and scenarios to examine and discussing the experience of taking ARV medicines. In principle, such an approach provides a tool for conscientization, action and the invention of novel group and individual repertoires that may result in individual mobilization for improving adherence to treatment and reducing his/her vulnerability.
16290170|NCT00716040|Other|Usual care|The control group will be submitted to the usual care of the health service
16290171|NCT00716027|Behavioral|Standard behavioral treatment for weight loss|A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
16290210|NCT00715780|Drug|biphasic insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290394|NCT00714246|Drug|Carboplatin|Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
16290172|NCT00716027|Behavioral|Modified behavioral treatment for weight loss|A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
16290173|NCT00716014|Drug|TD101|TD101 is injection into a callus on the bottom of one of the patient's feet
16290174|NCT00716014|Drug|Normal saline (placebo)|A normal saline solution (placebo) is injected into one of the patient's feet.
16290175|NCT00716001|Drug|N-acetylcysteine|
16290176|NCT00715988|Drug|Methadone HCl Inject 10 mg/ml (will require dilution)|Methadone HCl oral solution 5 mg/ml Methadone HCl inject 10 mg/ml (will require dilution)
16290177|NCT00715988|Drug|Methadone|Methadone HCl oral solution 5 mg/ml Methadone HCl inject 10 ml/ml (will require dilution) Single dose
16290178|NCT00715975|Drug|halobetasol|The patients will be treated with halobetasol once a day for 15 days.
16290179|NCT00715975|Drug|clobetasol|The patients will be treated with clobetasol once a day for 15 days.
16290180|NCT00715962|Behavioral|Behavioral intervention|Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.
16290181|NCT00715962|Other|Walking Intervention|Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only
16290182|NCT00715962|Other|Friendly visits|The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital.
16290183|NCT00715949|Other|Immediate Post-concussion Assessment and Cognitive Testing|ImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits.
16290184|NCT00715936|Behavioral|Control|
16290185|NCT00715936|Behavioral|ECD|
16290186|NCT00715936|Behavioral|Enhanced Nutrition|
16290187|NCT00715923|Other|Modified consent form|modified consent form used
16290188|NCT00715923|Other|Standard consent form|standard consent form used
16290189|NCT00715910|Biological|Nimenrix|One dose, as intramuscular injection
16290190|NCT00715910|Procedure|Blood sampling|Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
16290191|NCT00715897|Procedure|Hyperbaric Oxygen Therapy (HBOT)|8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
16290192|NCT00715884|Device|CYPHER® ELITE™ Sirolimus-Eluting Stent System|Drug eluting stent
16290193|NCT00715884|Device|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System|Drug eluting stent
16290194|NCT00715871|Drug|Nicotine|"Subjects received an amount of liquid nicotine cigarettes (containing 1.5mg of nicotine each) based on the amount of nicotine the subjects had been receiving from cigarettes. The number of liquid nicotine cigarettes received by each subject was reviewed, and adjusted (if necessary), every two weeks for the duration of the 12-week study."
16290195|NCT00715871|Device|Smoke-Break nicotine delivery device|"The Smoke-Break nicotine delivery device is a liquid nicotine cigarette designed to mimic the act of smoking. It is an NRT (nicotine replacement therapy) similar in concept to the nicotine patch, gum, and lozenge, except the nicotine is delivered in a way designed to duplicate the cigarette smoking experience. The Smoke-Break nicotine delivery device is non-invasive."
16290196|NCT00715858|Drug|doxycycline|capsule, 100 mg, b.i.d., 12 months
16290197|NCT00715858|Drug|rifampin|capsule, 300 mg, od, 12 months
16290198|NCT00715858|Drug|placebo|placebo matched to rifampin; placebo matched to doxycycline
16290199|NCT00715845|Procedure|Carbon dioxide insufflation|For baseline evaluations, all patients will undergo a battery of neuropsychological testing after obtaining written informed consent and before cardiac surgery. A transesophageal echocardiography and a transcranial doppler will be performed for intraoperative evaluations. For post-operative evaluations, patients will undergo a diffusion-weighted magnetic resonance imaging three to seven days after surgery and have a repeat neuropsychological assessment at six to eight weeks post cardiac surgery. All patients will undergo cardiopulmonary bypass using the same equipment and technique. Patients in both groups will receive a jackson-pratt drain as a gas diffuser. The jackson-pratt drain will be placed 5 cm below the cardiothoracic wound opening adjacent to the diaphragm and if the patient is randomized to carbon dioxide, the flow will be set at 2 litre/min.
16290200|NCT00715832|Biological|Dendritic Cell Vaccination|Autologous dendritic dells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally
16290201|NCT00715806|Device|Open MRI scanner.|Imaging in an Open MRI scanner.
16290202|NCT00715806|Device|Closed MRI scanner.|Imaging in a short-bore closed MRI scanner.
16290203|NCT00715793|Drug|Decitabine|"In Part I patients will be treated on a standard 3+3 phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle."
16290204|NCT00715793|Drug|Temozolomide|Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle.
16290205|NCT00715793|Procedure|biopsy|Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II.
16290206|NCT00715780|Drug|soluble human insulin|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290207|NCT00715780|Drug|biphasic human insulin|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290208|NCT00715780|Drug|insulin NPH|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290211|NCT00715780|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290212|NCT00715767|Behavioral|Assessment|"Cognitive Assessment:
~Knowledge base and critical thinking will be evaluated by a 50-question BLS multiple-choice examination. At the designated 4 cognitive assessments in the study (pre-course, immediately post course, 3 months and 6 months) 50 equivalent questions will be used to cover all core BLS objectives. Technical Skills Assessment:
~Primary outcome measures of adequacy of chest compressions and ventilations as well as key actions for each of the 3standardized basic life support skill tests during 3-minute testing scenarios. Video review by 2independent experts will be utilized for objective assessment of time and order dependent skills, and manikin output will be utilized to assess qualitative effectiveness of skills (adequate ventilation, compression, and defibrillation).
~Survey Instrument for Barriers to Acute Medicine Education:
~A survey tool will be used to identify barriers to acute medicine education implementation and efficacy."
16290213|NCT00715741|Other|FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water|FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water
16290214|NCT00715741|Other|FiO2 0.3 without PEEP|FiO2 0.3 without PEEP
16290215|NCT00715741|Other|FiO2 >0.9 with 3-5 cm water PEEP|FiO2 >0.9 with 3-5 cm water PEEP
16290216|NCT00715741|Other|FiO2 >0.9 without PEEP|FiO2 >0.9 without PEEP
16290217|NCT00715728|Device|Intraoperative warming with Bair Hugger forced air system|Intraoperative warming with Bair Hugger forced air system
16290218|NCT00715728|Device|Intraoperative warming with Hotdog resistive heating system|Intraoperative warming with Hotdog resistive heating system
16290219|NCT00715715|Drug|Prednisone Priming|For randomly selected patients treated with steroids: The patients will receive prednisone 30 mg daily for 3 weeks, 15 mg daily for 1 week, no treatment for 2 weeks, followed by Adefovir dipivoxil (Hepsera) 10 mg daily for a minimum of 52 weeks.
16290220|NCT00715702|Drug|AZD5672|100 mg oral single dose
16290221|NCT00715689|Drug|NNC126-0083|Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16290222|NCT00715689|Drug|NNC126-0083|Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16290223|NCT00715689|Drug|NNC126-0083|Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16290224|NCT00715689|Drug|NNC126-0083|Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
16290225|NCT00715689|Drug|placebo|Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16290226|NCT00715689|Drug|placebo|Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16290227|NCT00715689|Drug|placebo|Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16290228|NCT00715689|Drug|placebo|Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
16290229|NCT00715676|Drug|Placebo|oral, once daily
16290230|NCT00715676|Drug|DP001|oral, once daily
16290231|NCT00715663|Drug|biphasic insulin aspart 30|No intervention is done. For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
16290232|NCT00715650|Behavioral|Benefits Counseling|Benefits counseling is designed to improve the quality of life of disability applicants by accomplishing two functions: 1) Providing information concerning what vocational rehabilitation services are available and how they will affect receipt of disability payments, 2) Amplifying applicants' existing motivation to engage in work and related-activities, using a Motivational Interviewing approach.
16290233|NCT00715650|Behavioral|VA Orientation|VA Orientation is designed to provide the Veteran with information regarding the services available, how to access the services and where the service is located on the VA campus.
16290234|NCT00715637|Drug|Daunorubicin and Cytarabine|Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)
16290235|NCT00715637|Drug|Amonafide and Cytarabine|Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)
16290236|NCT00715624|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16290237|NCT00715624|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16290238|NCT00715624|Drug|Basal Insulin|Dose to be kept stable.
16290239|NCT00715624|Drug|Metformin|Metformin if given to be continued at stable dose (1.5 gram per day) up to the end of treatment.
16290240|NCT00715624|Device|Pen auto-injector|
16290241|NCT00715611|Procedure|Pleurectomy/Decortication|Pleurectomy/decortication will be performed as per standard technique
16290242|NCT00715611|Drug|pemetrexed and cisplatin or carboplatin|The combination of pemetrexed and cisplatin or carboplatin will be given every 3 weeks for up to 4 cycles. Pemetrexed will be administered at 500mg/m2 as a 10-minute infusion. Cisplatin will be administered at 75mg/m2 as a 60-minute infusion. Carboplatin will be administered at an AUC of 5 over 30 minutes. Chemotherapy may be administered in the neoadjuvant or adjuvant setting.
16290243|NCT00715611|Radiation|Intensity Modulated Radiation Therapy|IMRT will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions with an optional SIB to gross residual disease (pending meeting normal tissue constraints).
16290244|NCT00715585|Behavioral|Active Control|patients receive 3 individualized visits with a health educator focused on general diabetes education and health promotion
16290245|NCT00715585|Behavioral|int arm 1|VVpatients receive 3 individualized visits with an rd-cde for education focused on modified plate method
16290246|NCT00715585|Behavioral|int arm 3|patients receive 3 individualized visits with an rd-cde for education focused on carb counting
16290247|NCT00715572|Drug|thyroxine|monotherapy with thyroxine
16290248|NCT00715572|Drug|thyroxine and triiodothyronine|combination with thyroxine and triiodothyronine
16290275|NCT00715325|Device|Protectiscop CS|Patients who are indicated for screening colonoscopy will be recruited into the trial. The ProtectiScope CS sleeve is assembled on the colonoscope.standard colonoscopy is performed. Subjects will be followed for 1-month post procedure.
16290276|NCT00715312|Other|Novel Olein|A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake
16290249|NCT00715559|Drug|cysteamine bitartrate|All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients without intolerable side effects will increase the dose to 300 mg three times daily. The titration schedule will continue up to a maximum of 1800 mg a day. In case of adverse events, the investigator may decrease the dose by 150 mg daily.
16290250|NCT00715546|Procedure|autologous transplantation of liposuction material enriched with adipose-derived stem cells|Lipoinjection enriched with adipose-derived stem-cells.
16290251|NCT00715520|Other|Transcranial Magnetic Stimulation (TMS)|Each TMS training session will begin with a baseline measurement lasting about 30 minutes in which brief magnetic pulses will be generated by the single-pulse and paired pulse TMS stimulator and the responses are recorded with surface EMG electrodes. Participants will be instructed to move their wrist for up to ½ hour. After these measures, rTMS will be applied to the scalp during training. Stimulation will occur at a low rate of different frequencies and different times with respect to the training movement depending on the experimental condition. In the last phase of the session post-training measurements will be done using single TMS pulses. TMS pulses and intensity with be given in random order.
16290252|NCT00715520|Drug|Carbidopa-Levodopa|"Participants will receive one oral dose of carbidopa-levodopa 25mg one hour prior to measuring wrist extension movements.
~The order in which Carbidopa-Levodopa is given will be randomized per participant."
16290253|NCT00715520|Drug|Methylphenidate|"Participants will receive one oral dose of methylphenidate 40mg 2 hours prior to measuring wrist extension movements.
~The order in which Methylphenidate is given will be randomized per participant."
16290254|NCT00715520|Drug|Amphetamine Sulfate|"Participants will receive one oral dose of amphetamine sulfate 10mg 2 hours prior to measuring wrist extension movements.
~The order in which Amphetamine Sulfate is given will be randomized per participant."
16290255|NCT00715520|Drug|Placebo|"Participants will receive one oral tablet of placebo 2 hours prior to measuring wrist extension movements.
~The order in which Placebo is given will be randomized per participant."
16290256|NCT00715520|Other|Sham Transcranial Magnetic Stimulation (TMS)|Sham TMS pulses will be randomly administered during TMS sessions.
16290257|NCT00715520|Other|Transcranial Magnetic Stimulation (TMS) Training|TMS surface electromyographic activity will be recorded with surface electrodes mounted on the skin overlaying a forearm muscle. Single pulses of TMS at increasing intensity will be delivered to measure motor cortex excitability. Peak acceleration and TMS evoked responses in the muscle will be measured prior to the training, after completion of the training and again one hour after completion of the training.
16290258|NCT00715507|Device|medication monitor|the medication monitor will aid in expertise and decision-making.
16290259|NCT00715494|Behavioral|Cognitive, physical, and functional rehabilitation|A multicomponent program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients in their home environments over a focused 12 week period with the aid of tele-technology to utilize the expertise of physical therapy, occupational therapy, and neuropsychology.
16290260|NCT00715455|Drug|REG1|ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at approximately 10% the total reversal dose followed by the remaining dose several hours later to counteract RB006 induced anticoagulation.
16290261|NCT00715455|Drug|REG1|ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at 100% of the total reversal dose to counteract RB006 induced anticoagulation.
16290262|NCT00715455|Drug|Unfractionated Heparin|Heparin will be administered per standard of care at sites
16290263|NCT00715442|Drug|Sunitinib|50 mg by mouth daily for 28 consecutive days
16290264|NCT00715442|Procedure|Nephrectomy|Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
16290265|NCT00715429|Drug|vitamin d|After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
16290266|NCT00715429|Drug|placebo|After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
16290267|NCT00715416|Device|Nitinol stent|Interventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram.
16290268|NCT00715416|Procedure|Nitinol Stent Placement|Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
16290269|NCT00715403|Drug|BIBF 1120|
16290270|NCT00715377|Drug|Benztropine|Patients aged ≥ 50 years suffering from a primary psychotic disorder treated with a SGA and benztropine concomittantly at any dose steadily for at least 3 months will be eligible to participate in this study. The dose of benztropine will be reduced by 0.5mg per week. During this 8-week study period, extrapyramidal symptoms will be assessed on a weekly basis. The clinical assessments will be repeated 8 weeks after the initial assessments.
16290271|NCT00715364|Drug|NTx™-265: rhCG, then rEPO|"rhCG 385 µg, SC, on Day 1, 3, and 5 of study participation, then
~rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation"
16290272|NCT00715364|Drug|Saline Placebo|"Saline SC, on Day 1, 3, and 5 of study participation, then
~Saline IV, on Day 7, 8, and 9 of study participation"
16290273|NCT00715351|Drug|insulin detemir|Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
16290274|NCT00715351|Drug|insulin NPH|Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
16290277|NCT00715312|Other|Novel Olein|A total of 70g of test oil is incorporated into cooked meal which provides 30-35% of calorie
16292070|NCT00702130|Drug|Pravastatin|pravastatin 40mg per os once daily
16290278|NCT00715299|Behavioral|locomotor training|Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
16290279|NCT00715286|Other|timing of surgery|Surgery is followed by chemotherapy
16290280|NCT00715286|Other|timing of surgery|Chemotherapy is followed by surgery
16290281|NCT00715273|Drug|Atorvastatin|10 to 80 mg of atorvastatin each day
16290282|NCT00715273|Drug|Niacin|2000 mg of niacin each day
16290283|NCT00715273|Drug|Colesevelam|3.8 g of colesevelam each day
16290284|NCT00715273|Drug|Placebo Niacin|Placebo niacin each day
16290285|NCT00715273|Drug|Placebo Colesevelam|Placebo colesevelam each day
16290286|NCT00715234|Other|Reminder/recall notices for vaccines|"Receive a generic letter reminding them to make an appointment to get vaccines.
~Receive a computer-generated telephone message at 1 week post initial letter.
~Receive a computer-generated telephone message at 2 months post initial letter.
~Receive a letter at 3 months post initial letter."
16290287|NCT00715208|Drug|rituximab|
16290288|NCT00715208|Drug|cyclophosphamide|
16290289|NCT00715208|Drug|doxorubicin|
16290290|NCT00715208|Drug|VELCADE|
16290291|NCT00715208|Drug|prednisone|
16290292|NCT00715195|Behavioral|Plurifocal educational program|intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy
16290293|NCT00715182|Drug|TKI258|
16290294|NCT00715169|Drug|MLN1202|10 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour
16290295|NCT00715169|Other|Placebo|Placebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour
16290296|NCT00715143|Device|Novation Ceramic|This treatment is the study device (which will be compared to a similar historic control device)
16290297|NCT00715130|Behavioral|Energy Balance|We propose to develop and test a comprehensive intervention that will provide simple strategies related to dietary intake and energy expenditure that individuals can follow to achieve a balance in their energy intake and expenditure, while simultaneously changing structural and environmental cues to focus on promoting information, social support and opportunities for managing energy intake and increasing physical activity.
16290298|NCT00715117|Drug|Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks
16290299|NCT00715117|Other|Placebo, sugar pill|Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
16290300|NCT00715104|Biological|Sipuleucel-T with Booster|Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
16290301|NCT00715104|Biological|Sipuleucel-T without Booster|Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
16290302|NCT00715091|Drug|diclophenac|continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily
16290303|NCT00715091|Drug|diclophenac|treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily
16290304|NCT00715078|Biological|sipuleucel-T|Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
16290305|NCT00715065|Procedure|fMRI Scan|Subjects will undergo a functional MRI scan of the head lasting ~45 minutes. They will be repeatedly shown video clips of blood, other disgusting things, or are neutral.
16290306|NCT00715052|Procedure|Hyperbaric Oxygen Therapy (HBOT)|40 consecutive one hour treatments at 1.5 ATA with 100% O2
16290307|NCT00715039|Drug|lorazepam|1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
16290308|NCT00715039|Drug|placebo|placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
16290309|NCT00715039|Drug|paroxetine|20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
16290310|NCT00715026|Device|Trilogy AB Acetabular Hip Implant System|Total hip replacement with ceramic on ceramic treatment surfaces.
16290311|NCT00715013|Drug|Patupilone|Patupilone
16290312|NCT00715000|Procedure|Oral rehydration therapy|oral rehydration solution
16290313|NCT00715000|Procedure|classical hydration via intravenous infusion|intravenous infusion
16290314|NCT00714974|Device|BIS|Sedation dosing based on BIS value, oer treating physician discretion.
16290315|NCT00714961|Drug|Clopidogrel (SR25990)|plus acetylsalicylic acid (ASA)
16290316|NCT00714961|Drug|Placebo|plus acetylsalicylic acid (ASA)
16290317|NCT00714948|Drug|gemcitabine and cisplatin plus sorafenib|Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months. The total chemotherapy dose for gemcitabine and cisplatin (GC) may be modified for patients with severe obesity (e.g. body surface area (BSA) > 2.1), after consultation with the Principal Investigator.
16290318|NCT00714935|Behavioral|Decision Counseling Program (DCP)|An individual decisional counseling program (DCP) to help them comprehend the information, adjust this information to their personal illness history and elicit their preferences for cardiac risk fctor modification behavior in light of this personalized information
16290392|NCT00714259|Other|Infusion of Stem Cells|On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
16290319|NCT00714935|Behavioral|Coronary Artery Disease Decision Aid|"Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke
~The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing."
16290320|NCT00714922|Procedure|PRK|Laser refractive surgery
16290321|NCT00714922|Procedure|SBK|Laser refractive surgery
16290322|NCT00714896|Behavioral|Stepped-Care|"stage-based expert system written intervention at baseline and 3 months
~in-person stage appropriate counseling at baseline and 3 months
~telephone counseling sessions at weeks 2,4 and 8,
~as-needed brief check-in calls on or 2 days after quit date for those who have set a quit date; and/or check-in calls on days with anticipated high risk situations for former smokers or those who have quit smoking during the study
~optional NRT nicotine replacement therapy in the forms of patch, gum or lozenge for current smokers who are ready to quit smoking and/or for former smokers who report significantly strong smoking urges"
16290323|NCT00714896|Behavioral|Control|Referral list to smoking cessation classes at Kaiser and the California Smokers Helpline
16290324|NCT00714883|Device|NEVO™ Sirolimus-eluting Coronary Stent System|Intervention will consist of percutaneous coronary intervention for treatment of lesions in native coronary arteries using standard coronary intervention techniques. Intervention will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
16290325|NCT00714870|Behavioral|Behavioral nutrition and exercise program|The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects.
16290326|NCT00714857|Drug|Dexmedetomidine|The patients are given a normal loading dose (10 min infusion at a rate of 3-6 μg/kg/h) of dexmedetomidine followed by continuous infusion of 0.1 - 2.5 μg/kg/h for the period of time the responsible physician finds reasonable.
16290327|NCT00714831|Behavioral|Physical activity intervention|3-months physical activity intervention
16290328|NCT00714831|Behavioral|Health educational program|Health education sessions and stretching sessions
16290329|NCT00714818|Behavioral|Genetic Counseling|One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required
16290330|NCT00714818|Behavioral|Genetic Counseling|One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants.
16290331|NCT00714779|Drug|Fluoxetine|20-40 mg / day orally
16290332|NCT00714779|Behavioral|Short-term psychodynamic psychotherapy|1 session / week for 16 weeks
16290333|NCT00714766|Procedure|Intravascular volume administration|Infusion of colloid to reestablish CVP under heat stress
16290334|NCT00714753|Radiation|brachytherapy|
16290335|NCT00714753|Radiation|hypofractionated radiation therapy|
16290336|NCT00714753|Radiation|image-guided radiation therapy|
16290337|NCT00714753|Radiation|intensity-modulated radiation therapy|
16290338|NCT00714740|Drug|acetazolamide|acetazolamide 2 times 250mg per day
16290339|NCT00714727|Procedure|acupuncture|8 weeks of acupuncture, starting with twice a week for 4 weeks, followed by once a week for 4 weeks, using 8 standardized, bilateral acupuncture points.
16290340|NCT00714714|Drug|Adapalene Gel|adapalene gel 0.3% topically applied daily in a split-face model for two weeks
16290341|NCT00714714|Drug|Tretinoin Gel|Tretinoin 0.1% topically applied daily in a split face model for two weeks
16290342|NCT00714688|Drug|prolonged release (PR) OROS methylphenidate 54 mg|18+36mg once daily for 13 weeks
16290343|NCT00714688|Drug|prolonged release (PR) OROS methylphenidate 72 mg|2x36mg once daily for 13 weeks
16290344|NCT00714688|Drug|Placebo|2xplacebo once daily for 13 weeks
16290345|NCT00714675|Dietary Supplement|Citrulline|1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
16290346|NCT00714675|Dietary Supplement|Amino acids|1 unit of an equivalent quantity of iso nitrogenous of non-essential amino acids(alanine, aspartate, glycine, serine, histidine, proline), 1 time on morning during 21 days.
16290347|NCT00714662|Device|high flux hemodialyzer (FX-60, FX-80 or FX-100)|three sessions per week
16290348|NCT00714649|Drug|cetuximab|Cetuximab 250mg/m²/week IV before surgery till surgery
16290349|NCT00714623|Device|Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)|Indications for use: The CYPHER™ Sirolimus-eluting Coronary Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter between 2.5 and 3.5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.
16290350|NCT00714597|Drug|Semuloparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16290351|NCT00714597|Drug|Enoxaparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16290352|NCT00714584|Drug|Naltrexone HCl.|
16290353|NCT00714571|Behavioral|Mnemonic strategy training (MST)|
16290354|NCT00714571|Behavioral|Repeated exposure (XP)|
16290355|NCT00714571|Behavioral|Subtracting Cues training|
16290356|NCT00714558|Drug|Fentanyl citrate; Naltrexone; Naloxone|
16290357|NCT00714545|Radiation|Intracoronary brachytherapy|Beta irradiation with a 40-mm strontium/lytrium-90 source
16290358|NCT00714532|Behavioral|Expert System Only|Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months
16290393|NCT00714246|Drug|Bortezomib|Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
16290359|NCT00714532|Behavioral|Enhanced Expert System|"The intervention consists of 3 components:
~Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months
~scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention
~telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials
~a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction"
16290360|NCT00714519|Drug|Xenaderm® Ointment|Topical, BID or as needed
16290361|NCT00714519|Drug|Placebo Comparator|Topical, BID or as needed
16290362|NCT00714506|Behavioral|Diet and physical activity|lifestyle weight reduction - low fat eating, low calorie and physical activity
16290363|NCT00714506|Other|Physical activity control|physical activity plus successful aging health education
16290364|NCT00714493|Biological|Infliximab|3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
16290365|NCT00714480|Drug|anti-thymocyte globulin|Administration of anti-thymocyte globulin at post-operative days -6, -4, -2 and 0
16290366|NCT00714480|Drug|anti-thymocyte globulin|anti-thymocyte globulin post-operative days -2, 0, 2 and 4
16290367|NCT00714480|Drug|anti-thymocyte globulin|Post-operative days 0, 2, 4 and 6
16290368|NCT00714467|Behavioral|Expert System Only|expert system intervention only to the smoker participants which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters receive assessments only and no intervention.
16290369|NCT00714467|Behavioral|Family Assisted|The smoker participants received an expert system intervention (same intervention for those in the Expert system intervention) which includes a stage-based manual and a series of 3 individualized tailored feedback report at baseline, 3, and 6 months. The paired-supporters will receive a a self-help booklet based on the Transtheoretical Model of Change (TTM) that will aim at teaching the supporters how to use the stages of change framework to apply different strategies that best match with smokers' readiness to quit smoking.
16290370|NCT00714454|Other|APS Topical Lotion|
16290371|NCT00714454|Other|Placebo|
16290372|NCT00714441|Behavioral|Lifestyle and Activities Education Program (LEAP-AHEAD)|Patients in the LEAP-AHEAD Program arm will be shown a 40-minute interactional DVD and given the Healthy Habits Health Risk Appraisal, at baseline and 20 weeks that asks questions about diabetes self care practices and other health behaviors and gives recommendations in those areas. A score sheet based on the participant's responses will be left with the participant. At intervals from 0 to 44 weeks, patients will receive emailed informational pamphlets on diabetes and its complications, along with live telephone calls to answer any questions and check-in.
16290373|NCT00714441|Behavioral|Computer Automated Self-Management (CASM)|CASM is a live and computer-assisted, low intensity, automated web and telephony based program that is directed at enhancing and sustaining diabetes self-management behavior over time. It provides education on the importance of healthy eating, physical activity and medication taking, and then asks patients to select an area for behavior change. At baseline patients will have a 45 minutes home visit to help them set goals and familiarize them with the website. A booster session is given at 20 weeks. Patients receive 8 ive phone calls over 12 months to support behavior change efforts.
16290374|NCT00714441|Behavioral|Computer Automated Self-Management and Problem Solving Therapy (CAPS)|Patients in the CAPS program receive all of the protocol included in the CASM program, and in addition receive a Problem Solving program. Problem solving is a process by which an individual attempts an adaptive solution to stressful, real life problem(s). At baseline there is a 45 minute home visit where the Counselor will introduce the patient to CASM and will go on to teach the patient about diabetes distress and PST. They will then generate a list of distress-related problems to teach the steps of PST. The steps of PST are: problem definition, goal setting, brain storming, decision making, action planning, and solution review. At 20 weeks there will be a booster session. Patients receive 8 live phone calls over 12 months to support behavior change efforts.
16290375|NCT00714415|Drug|BeneFIX|Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16290376|NCT00714376|Drug|Docetaxel|75 mg/m2 iv every 3 weeks for 8 cycles
16290377|NCT00714363|Procedure|LASIK|Refractive surgery
16290378|NCT00714363|Procedure|SBK|Refractive surgery
16290379|NCT00714350|Behavioral|New ICU Display Visualization|
16290380|NCT00714337|Drug|AZD1386|One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).
16290381|NCT00714337|Drug|AZD1386|One single oral dose of 90mg (3 x 30mg AZD1386 capsules)
16290382|NCT00714337|Drug|AZD1386|One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
16290383|NCT00714311|Behavioral|Transference-Focused Psychotherapy|Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week
16290384|NCT00714311|Behavioral|treatment by experienced community psychotherapists|Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned.
16290385|NCT00714298|Other|Measure of Initial heart fatty acid binding protein and ischemia modified albumin|Initial heart fatty acid binding protein and ischemia modified albumin will be measured after patient's arrival in the emergency room. The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.Treating physicians, biologist physician will be blinded to the results of the markers.
16290386|NCT00714285|Biological|GSK Biologicals' quadrivalent influenza vaccine|Single intramuscular dose on Day 0.
16290387|NCT00714285|Biological|GSK Biologicals' trivalent influenza vaccine|Single intramuscular dose on Day 0.
16290388|NCT00714272|Device|Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1|6 treatments. One per week during the first six consecutive weeks.
16290389|NCT00714272|Device|Treatment with a sham device, EXcorLab box 1.2|6 sham treatments. One treatment per week during the first six consecutive weeks.
16290390|NCT00714259|Drug|Fludarabine|Fludarabine 30 mg/m2/day x 3 days
16290391|NCT00714259|Radiation|Total Body Irradiation|TBI 200cGy x1 dose on transplant day
16290395|NCT00714246|Drug|Docetaxel|Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
16290396|NCT00714233|Drug|Metformin|Metformin 425mg. capsules, 2 capsules BID x 24 weeks
16290397|NCT00714233|Drug|Oral Contraceptive Pills (Yasmin)|Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
16290398|NCT00714233|Behavioral|Lifestyle Modification|weekly classes x 24 weeks for training in diet, exercise and behavior modification skills
16290399|NCT00714233|Drug|placebo|placebo to the active metformin arm. 2 capsules BID x 24 weeks.
16290400|NCT00714207|Behavioral|NOT program|Students in this arm of the study received the reformatted NOT intervention
16290401|NCT00714207|Behavioral|NOT controls|Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
16290402|NCT00714207|Behavioral|Kicking Butts intervention|Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention
16290403|NCT00714207|Behavioral|KB controls|Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
16290404|NCT00714194|Procedure|Normal continuous sedation|Normal continuous sedation.
16290405|NCT00714194|Other|Daily interruption of continuous sedation|Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation.
16290406|NCT00714181|Drug|hydroxychloroquine|
16290407|NCT00714181|Drug|temozolomide|
16290408|NCT00714181|Genetic|TdT-mediated dUTP nick end labeling assay|
16290409|NCT00714181|Genetic|western blotting|
16290410|NCT00714181|Other|electron microscopy|
16290411|NCT00714181|Other|high performance liquid chromatography|
16290412|NCT00714181|Other|immunoenzyme technique|
16290413|NCT00714181|Other|immunohistochemistry staining method|
16290414|NCT00714181|Other|laboratory biomarker analysis|
16290415|NCT00714181|Other|mass spectrometry|
16290416|NCT00714181|Other|pharmacological study|
16290417|NCT00714168|Behavioral|Standard Behavioral Weight Loss Program|This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
16290418|NCT00714168|Behavioral|Stepped-Care Weight Loss Program|In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
16290419|NCT00714155|Other|Questionnaires, Physical Examination|Questionnaires, Physical Examination
16290420|NCT00714142|Drug|62Cu-ethylglyoxal bis(thiosemicarbazone)|15-25 mCi, IV
16290421|NCT00714142|Drug|15O-water|10-20 mCi, IV
16290422|NCT00714142|Procedure|Positron Emission Tomography|PET Scan
16290423|NCT00714129|Other|Dietary intervention (calorie restricted diet)|Participants in Aim 2 will receive a calorie restricted diet. This group will receive all their food for approximately 8 weeks which is the similar composition of their current diet.
16290424|NCT00714129|Other|Dietary intervention (calorie restricted diet)|Participants in Aim 2 will receive a calorie restricted diet. This group will receive all their food for approximately 8 weeks which is lower in simple sugars, specifically fructose.
16290425|NCT00714116|Drug|SBI-087|Single IV or SC dose of SBI-087
16290426|NCT00714103|Drug|8-Chloro-Adenosine|45 mg/m^2 intravenous over 1 hour daily for 5 days every 4 weeks (± 3 days).
16290427|NCT00714090|Other|active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed|"active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
~active rTMS : 5 sessions per week for 2 to 6 weeks"
16290428|NCT00714090|Other|active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine|active rTMS : 5 sessions per week for 2 to 6 weeks sham venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
16290429|NCT00714090|Other|sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine|sham rTMS : 5 sessions per week for 2 to 6 weeks active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
16290430|NCT00714064|Biological|23vPPV, dTpa (Pneumovax, Boostrix)|Group A will receive 23vPPV during 3rd trimester and dTpa at delivery
16290431|NCT00714064|Biological|23vPPV, dTpa (Pneumovax, Boostrix)|Group B will receive 23vPPV at delivery and dTpa 7 months following delivery
16290432|NCT00714064|Biological|23vPPV, dTpa (Pneumovax, Boostrix)|Group C will receive dTpa at delivery and 23vPPV 7 months following delivery
16290433|NCT00714051|Behavioral|fall prevention training|Training on a specialized treadmill that produced trip-simulating perturbations (movements.
16290434|NCT00714051|Behavioral|Attention Control|Participants walked on a treadmill at a self-selected speed once per week for four weeks.
16290435|NCT00714025|Drug|RAD001|RAD001 10mg, daily, PO
16290436|NCT00714012|Other|observational|presented with paper-based sets, web based sets or human simulator based set of questionnaires designed to identify the users' experience level and optimal visual or auditory elements for each specific domain.
16290437|NCT00713999|Drug|Treatment with anti-STI and anti-schistosoma regimens|Anti-STI regimen: ciprofloxacin 500mg orally, doxycycline 100mg BID orally 7 days and metronidazole 2g orally (cefuroxime im and/or azithromycin alternatively for pregnant and breastfeeding women) Anti-schistosoma regimen: Praziquantel 40mg/kg
16290438|NCT00713986|Procedure|Water 2mL PO 2 minutes prior to intra-muscular injection|Sterile Water 2mL PO - single dose
16290439|NCT00713986|Procedure|skin-to-skin contact|neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
16290440|NCT00713986|Procedure|Glucose 25% 2 mL PO 2 minutes prior to injection|Glucose 25% 2mL PO - single dose
16290476|NCT00713726|Drug|FentanyL|Fentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.
16292071|NCT00702117|Drug|flecainide|2 mg/kg iv in 10 minutes
16290441|NCT00713986|Procedure|neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.|neonates will receive 2 mL of glucose 25% PO (single dose) 2 minutes prior to the acute painful procedure. Skin-to-skin contact will start 2 minutes after the intra-muscular injection and will stop 2 minutes afterwards.
16290442|NCT00713947|Drug|during one week for the active treatments|during one week for the active treatments placebo during 25 weeks
16290443|NCT00713947|Drug|Pantoprazole|6 months at 20 mg
16290444|NCT00713947|Drug|Placebo Formula 515|26 weeks, one tablet per day
16290445|NCT00713934|Biological|CD133|portal vein infusion of CD133+ cells
16290446|NCT00713934|Biological|BM-MNC|portal vein infusion of BM-MNC
16290447|NCT00713921|Drug|Fesoterodine Oral Product|After urological and neurological evaluation, those patients who meet he US approved indications for prescribing will be placed on a regimen of Toviaz 4 mg/day taken once daily with liquids and swallowed whole. The Toviaz dose may be increased to 8 mg/day if there is not therapeutic response on the 4 mg/day.
16290448|NCT00713895|Behavioral|Expert System|an expert system intervention provided the Pathway-To-Change self-help manual and a series of 3 individualized feedback reports at baseline, 3, and 6 months.
16290449|NCT00713895|Behavioral|Standard Self-Help|standard smoking cessation self-help manual
16290450|NCT00713856|Procedure|Custom PRK with iris registration|PRK
16290451|NCT00713856|Procedure|Conventional PRK|PRK
16290452|NCT00713843|Other|Manual Therapy Utrecht|Manual Therapy (6 weeks).
16290453|NCT00713843|Other|Physical Therapy|Physical Therapy (six weeks).
16290454|NCT00713830|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16290455|NCT00713830|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16290456|NCT00713830|Device|Pen auto-injector|
16290457|NCT00713830|Drug|Sulfonylurea|Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.
16290458|NCT00713830|Drug|Metformin|Metformin if given to be continued at stable dose (at least 1.5 gram per day [except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea]) up to the end of treatment.
16290459|NCT00713817|Drug|Sativex®|Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290460|NCT00713817|Drug|Placebo|containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient
16290461|NCT00713804|Behavioral|Genetic Counseling|One face-to-face genetic counseling session of 1-2hours duration, with a board certified or board eligible genetic counselor which will involve, documentation of a detailed family history, discussion of: the contributors to mental illness pathogenesis, illness risk reduction strategies, chances for family members to develop mental illness (if required), supportive counseling around living with illness/risk of illness/managing illness vulnerability, and referral to support organizations as required.
16290462|NCT00713804|Behavioral|Educational Booklet|One educational booklet that provides information about the causes of mental illnesses, and the chances for relatives of affected individuals to develop mental illness will be provided to participants.
16290463|NCT00713791|Drug|ZD4054|Treatment period 1: 10mg oral solution
16290464|NCT00713791|Drug|ZD4054|Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
16290465|NCT00713791|Drug|ZD4054|Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
16290466|NCT00713791|Drug|ZD4054|Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.
16290467|NCT00713778|Procedure|Ovarian cystectomy|Laparoscopic ovarian cystectomy using bipolar
16290468|NCT00713778|Procedure|Ovarian cystectomy|Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
16290469|NCT00713778|Procedure|Ovarian cystectomy|Laparotomic ovarian cystectomy using suture
16290470|NCT00713765|Drug|AZD3480|18 total doses of 40 mg, on days 1-18
16290471|NCT00713765|Drug|Donepezil|One single dose of mg on day 5
16290472|NCT00713739|Drug|Alfuzosin|Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg BID. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.
16290473|NCT00713739|Drug|nifedipine|Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg BID. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.
16290474|NCT00713739|Drug|doxazosin|Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg BID. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.
16290475|NCT00713739|Drug|prazosin|Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg BID. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.
16290477|NCT00713726|Drug|Tramadol|Tramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.
16290478|NCT00713713|Procedure|Mechanical ventilation with low and high tidal volume|Tidal volume of 6 or 12 ml.kg-1, calculated on ideal body weight
16290479|NCT00713700|Device|AMPLATZER Duct Occluder II|AMPLATZER Duct Occluder II
16290480|NCT00713687|Drug|Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)|"Photodynamic therapy (PDT) after successful drainage:
~Photosan® 2 mg/kg i.v. 48 hrs before laser activation
~9 cycles of GemOx chemotherapy (start 4 weeks after PDT):
~Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy
~Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy
~iteration every 14 days
~afterwards 4 weeks intermission
~Iteration of 1. and 2. in case of good compatibility"
16290481|NCT00713674|Other|Theraworx|Theraworx swab intranasal BID for 5 days
16290482|NCT00713674|Drug|mupirocin antibiotic ointment|mupirocin antibiotic ointment swab intranasal BID for 5 days
16290483|NCT00713661|Drug|TachoSil®|"Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin.
~Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy."
16290484|NCT00713648|Drug|catridecacog|35 IU/kg body weight, i.v. administration, once every 4 weeks
16290485|NCT00713622|Drug|Zonisamide|Capsules of 25mg, 50mg and 100mg zonisamide will be supplied. Dosing will be twice a day.
16290486|NCT00713622|Drug|Sodium valproate|Crushable tablets of 100mg and enteric coated tablets of 200mg and 500mg will be supplied. Dosing will start at 600mg/day, increasing to the minimally effective dose, the maximum tolerated dose, or 2500mg/day, whichever is the lowest.
16290487|NCT00713609|Drug|Benzoyl peroxide gel|5% benzoyl peroxide in a gel applied topically once a day
16290488|NCT00713609|Drug|Clindamycin gel|1% clindamycin phosphate applied topically once a day
16290489|NCT00713609|Drug|Tazarotene cream|0.1 % tazarotene in a cream applied topically once a day
16290490|NCT00713609|Drug|Vehicle gel|Vehicle gel is an identical gel without the active ingredients
16290491|NCT00713609|Drug|Vehicle cream|Vehicle cream is an identical cream without the active ingredients
16290492|NCT00713596|Drug|Fibrinogen|One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
16290493|NCT00713596|Procedure|Septorhinoplasty|Septorhinoplasty to correct nasal deviation.
16290494|NCT00713596|Procedure|Taping after septorhinoplasty.|Simple taping over the nose following nasal surgery.
16290495|NCT00713596|Procedure|Cast applied to the nose after nasal surgery|A molded cast will be placed on top of the nose following nasal surgery.
16290496|NCT00713596|Other|Saline|Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.
16290497|NCT00713583|Drug|levodopa|800mg levodopa and 200mg carbidopa per day
16290498|NCT00713583|Drug|Placebo|Placebo
16290499|NCT00713583|Behavioral|Cognitive Behavioral Therapy|Participants received individual cognitive behavioral therapy (CBT) in 50-minute weekly sessions. These sessions were manual-driven and based on the relapse prevention model proposed by Marlatt and Gordon (1985). Trained masters-level therapists, under the supervision of senior therapists and the principal investigator, worked with participants to teach them how to recognize and cope with risky situations that could influence their cocaine use through self-monitoring of situational craving and drug use stimuli, coping skills training, and lifestyle modifications.
16290500|NCT00713583|Behavioral|Contingency Management|An abstinence-based contingency management (CM) procedure was used. Participants earned vouchers according to the reward schedule recommended by Budney and Higgins (1998), beginning at $2.50 for the first cocaine-negative urine. For each consecutive cocaine-negative urine, voucher values increased by $1.25 with a $10 bonus given for provision of three consecutive cocaine-negative urines within a week. A cocaine-positive urine or failure to provide a scheduled urine sample resulted in a reset of the schedule to the initial value of $2.50. After provision of five negative urines, the voucher returned to the value prior to the reset. Participants were able to redeem their vouchers for small amounts of cash (≤$25) or gift cards for goods and services.
16290501|NCT00713557|Device|drug-eluting stent|drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
16290502|NCT00713557|Drug|Tirofiban|upstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading
16290503|NCT00713544|Drug|AZD5672|20 mg oral, once daily
16290504|NCT00713544|Drug|Etanercept|50 mg, subcutaneous injection, weekly
16290505|NCT00713544|Drug|Placebo|placebo, oral, once daily
16290506|NCT00713544|Drug|AZD5672|50 mg oral, once daily
16290507|NCT00713544|Drug|AZD5672|100 mg oral, once daily
16290508|NCT00713544|Drug|AZD5672|150 mg oral, once daily
16290509|NCT00713518|Drug|0.5 mg ranibizumab|
16290510|NCT00713518|Drug|3 mg PF-04523655|
16290511|NCT00713518|Drug|1 mg PF-04523655|
16290512|NCT00713505|Other|educational intervention|Parents receive face-to-face training sessions with a therapist over approximately 2-3 months. Phone support/assistance is provided by the therapist within 2-3 days following each training session and then every 2 weeks for up to 6 months after completion of the training sessions.
16290513|NCT00713505|Procedure|psychosocial assessment and care|Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).
16290514|NCT00713492|Drug|Alcohol|human laboratory alcohol consumption.
16290515|NCT00713479|Drug|Varenicline, then placebo|Subjects receive MA infusions on certain days first under varenicline (10 days) then under placebo (8 days) after a 14-24 day washout in order to determine study medication safety and tolerability
16290516|NCT00713479|Drug|Placebo, then varenicline|Subjects receive MA infusions on certain days first under placebo (10 days) then under varenicline(8 days) after a 14-28 day washout in order to determine study medication safety and tolerability
16290606|NCT00712712|Drug|Morphine Sulfate|Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.
16292072|NCT00702117|Drug|ajmaline|1 mg/kg iv in 10 minutes
16290517|NCT00713440|Other|Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol|"OGTT: The test is performed with 50 g of glucose deluded in 300 ml. of water. Isoglycaemic iv. clamp: Iv glucose infusion mimicking the glucose response curve of the OGTT.
~Liquid Meal Test: The test is performed with 100g of formula milk in 300 ml. of water.
~Gastric Emptying Rate: Paracetamol absorption test. Adrenocortical Steroids: Use of 37,5 mg./day of prednisolone during 10 days"
16290518|NCT00713427|Device|WallFlex™ Biliary Partially-Covered Stent|Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.
16290519|NCT00713401|Drug|Tecadenoson|Tecadenoson administered intravenously (i.v.)
16290520|NCT00713401|Drug|Esmolol|Esmolol low dose infusion according to manufacturer's instructions
16290521|NCT00713362|Procedure|Video-assisted thoracoscopic surgery|VATS for bullectomy and mechanical pleurodesis
16290522|NCT00713362|Procedure|chest tube drainage|Chest tube drainage for pneumothroax
16290523|NCT00713349|Drug|Xenaderm Vehicle|Ointment to be applied three times a day on cryo-surgery wound for 21 days.
16290524|NCT00713349|Other|Placebo comparator|Ointment to be applied three times a day on cryo-surgery wound for 21 days.
16290525|NCT00713336|Drug|ZD4054|ZD4054 10mg Tablet
16290526|NCT00713336|Drug|Moxifloxacin|400 mg capsule
16290527|NCT00713336|Drug|ZD4054 Placebo|3 tablets
16290528|NCT00713336|Drug|Moxifloxacin placebo|1 capsule
16290529|NCT00713336|Drug|ZD4054 Placebo|2 tablets
16290530|NCT00713336|Drug|ZD4054|30mg tablet
16290531|NCT00713336|Drug|ZD4054|10mg tablet
16290532|NCT00713323|Drug|Sativex®|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290533|NCT00713310|Drug|Asacol 400 mg|"High dose:
~17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM"
16290534|NCT00713310|Drug|Asacol 400 mg|"Low dose:
~17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM"
16290535|NCT00713297|Behavioral|satisfaction questionnaire|Satisfaction questionnaire
16290536|NCT00713284|Drug|sirolimus|Oral tablet(s) taken daily for 6 months; dose will be based on serum trough levels.
16290537|NCT00713271|Drug|AZD3199|"Low dose
~Dry powder for inhalation, o.d., 1+12 days"
16290538|NCT00713271|Drug|Placebo|
16290539|NCT00713271|Drug|AZD3199|"intermediate dose
~Dry powder for inhalation, o.d., 1+12 days"
16290540|NCT00713271|Drug|AZD3199|"high dose
~Dry powder for inhalation, o.d., 1+12 days"
16290541|NCT00713258|Drug|Parathyroid hormone (PTH) (1-84)|100 µg PTH(1-84) daily
16290542|NCT00713258|Drug|Alendronate|70 mg alendronate weekly
16290543|NCT00713219|Radiation|IMRT, cetuximab, docetaxel|IMRT will be administered in once daily fractions (2 Gy/day, Monday through Friday) over approximately 7 weeks to a goal of approximately 70 Gy. The chemotherapy regimen will begin with a loading dose of intravenous cetuximab (400 mg/m2) one week prior to the initiation of radiation therapy, followed by weekly administration of intravenous docetaxel (15 mg/m2) and intravenous cetuximab (250 mg/m2) for approximately 7 weeks concurrently with radiation. Patients will be evaluated weekly prior to their chemotherapy. All patients will be evaluated on an intention-to-treat basis.
16290545|NCT00713193|Drug|Cyclosporine|2-3 mg/kg orally in a twice day divided dose for 6 months
16290546|NCT00713193|Drug|Prednisone|1 mg/kg orally, daily for at least 30 days, then tapered over 30 days after achieving remission.
16290547|NCT00713180|Procedure|Pterygium excision followed by grafting|Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures
16290548|NCT00713167|Drug|Grape Seed Extract (Vitagrape)|"Drug {Each Containing: Grape Seed Extract100 mg +...}
~1 capsule twice daily for 2 months"
16290549|NCT00713167|Drug|Placebo of Grape Seed Extract|"Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}
~1 capsule twice daily for 2 months"
16290550|NCT00713154|Drug|MTS-01|MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
16290551|NCT00713154|Drug|Placebo|Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
16290552|NCT00713115|Procedure|needlescopic adrenalectomy and laparoscopic adrenalectomy|Needlescopic instruments, defined as those with a diameter of no more than 3 mm. They result in smaller incisions than conventional 5- to 12-mm instruments.
16290553|NCT00713076|Other|Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182|Lens Cleaning Solution Formulation Identification Number 109182
16290554|NCT00713063|Behavioral|aerobic exercise|12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
16290555|NCT00713063|Behavioral|Health Education Control|12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
16290556|NCT00713050|Behavioral|Imitate Therapy|Imitation-based computer therapy
16290557|NCT00713037|Procedure|Fluoromisonidazole-PET/CT|2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.
16290558|NCT00713011|Drug|Adalat XL|Patients will receive Avalide (Irbesartan/ hydrochlorothiazide; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day) during the 12 week screening period and during the 18 week treatment period. At baseline, patients will be provided with Adalat XL at a starting dose of 20 or 30 mg. Adalat XL will be titrated during the 18 week treatment period in order to optimize blood pressure. Adalat XL will be supplied in 20 mg, 30 mg, 60 mg, and 90 mg.
16290716|NCT00712010|Other|Hydrolyzed casein|versus the six other arms
16290717|NCT00712010|Other|Total milk protein native|versus the six other arms
16290718|NCT00712010|Other|Hydrolyzed milk protein|versus the six other arms
16290559|NCT00713011|Drug|Tiazac XC|Patients will receive Avalide (Irbesartan/ hydrochlorothiazide; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day) during the 12 week screening period and during the 18 week treatment period. At baseline, patients will be provided with Tiazac XC at a starting dose of 180 mg. Tiazac XC will be titrated during the 18 week treatment period in order to optimize blood pressure. Tiazac XC will be supplied in 180 mg, 240 mg, 300 mg and 360 mg.
16290560|NCT00712985|Drug|Zometa|Zometa (Zoledronic Acid) 5 mg IV over 15 minutes in a one time dose
16290561|NCT00712959|Biological|Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)|0.5 ml, IM
16290562|NCT00712959|Biological|Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)|0.5 mL, IM
16290563|NCT00712933|Drug|belimumab|"Recombinant, fully human, monoclonal antibody
~Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days."
16290564|NCT00712920|Drug|0.15% azelastine hydrochloride|0.15% azelastine hydrochloride 1644 mcg
16290565|NCT00712920|Drug|0.1% azelastine hydrochloride|0.1% azelastine hydrochloride 1096 mcg
16290566|NCT00712920|Drug|Placebo|Placebo
16290567|NCT00712907|Dietary Supplement|vitamin C (Mayrhofer) 24mg/min i.v. for 64 min|Substance: Ascorbic acid (Mayrhofer) Manufacturer: Mayrhofer, Linz, Austria Dosage form: i.v. Dosage: 24mg/min over 64 min Dosage reference: Ting HH 1996
16290568|NCT00712907|Dietary Supplement|Placebo|Substance: Physiologic saline solution 0.9% (placebo) Dosage form: i.v. Dosage: 24ml/min over 64 min
16290569|NCT00712907|Other|100% O2 (AGA) two times for 12 min|"Substance: 100% oxygen (AGA, Vienna, Austria, gases for human use) Manufacturer: AGA, Vienna, Austria, gases for human use Dosage form: Inhalation through an oxygenmask over a period of 12 minutes two times per study day.
~Dosage reference: Strenn K 1997"
16290570|NCT00712894|Drug|Diltiazem|Intracoronary Infusion 400-2000ug
16290571|NCT00712894|Drug|Verapamil|Intracoronary Infusion 200-1000ug
16290572|NCT00712894|Drug|Nitroglycerin|Intracoronary Infusion 200-1000ug
16290573|NCT00712881|Drug|MYOCET® Plus Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles|MYOCET® (60 mg/m2) and cyclophosphamide (600 mg/m2) and trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) once every 3 weeks for 4 cycles followed by docetaxel (100 mg/m2) and trastuzumab (6 mg/kg) once every 3 weeks for 4 cycles (MCH→TH).
16290574|NCT00712881|Drug|Free Doxorubicin Plus Cyclophosphamide, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles|Free doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) once every 3 weeks for 4 cycles followed by docetaxel (100 mg/m2) and trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) once every 3 weeks for 4 cycles (AC→TH).
16290575|NCT00712868|Drug|Lactic acid|Once a day
16290576|NCT00712855|Biological|mapatumumab|3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
16290577|NCT00712855|Drug|sorafenib|400 mg orally, twice a day continuously in each cycle
16290578|NCT00712842|Other|Ocular blood flow measurements|non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
16290579|NCT00712829|Drug|123-I-MIP-1072|10 mCi intravenous injection given one time during the study
16290580|NCT00712829|Drug|123-I-MIP-1095|10 mCi intravenous injection given one time during the study
16290581|NCT00712816|Device|Game Ready Injury Treatment System (CoolSystems Inc.)|Cold with intermittent compression postoperatively for 2 weeks
16290582|NCT00712816|Other|Ice with compressive bandages|Cold with static compression postoperatively for 2 weeks
16290583|NCT00712803|Biological|rDEN3-3'D4delta30|Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine.
16290584|NCT00712803|Biological|rDEN3-3'D4delta30|Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine.
16290585|NCT00712803|Biological|rDEN3-3'D4delta30|Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine.
16290586|NCT00712790|Drug|Sorafenib|Tablet, 400mg orally, twice daily
16290587|NCT00712790|Radiation|SIR-Spheres|one time treatment and capped at 3.0 Gbq
16290588|NCT00712777|Drug|Brimonidine 0.2 %|Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye
16290589|NCT00712764|Drug|Adenosine|
16290590|NCT00712764|Drug|Placebo|
16290591|NCT00712751|Behavioral|questionnaires|"Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, usual care will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline."
16290592|NCT00712751|Behavioral|CSI-SH- Cancer Survivorship Intervention|This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
16290593|NCT00712738|Drug|Nifedipine|
16290594|NCT00712738|Procedure|Phlebotomy|
16290595|NCT00712738|Procedure|Urinalysis|
16290596|NCT00712738|Procedure|Echocardiogram|
16290597|NCT00712738|Procedure|Electrocardiogram|
16290598|NCT00712725|Drug|MK3207- 2.5 mg|Arm 1: MK3207 2.5 mg taken after migraine onset.
16290599|NCT00712725|Drug|MK3207- 5 mg|Arm 2: MK3207 5 mg taken after migraine onset.
16290600|NCT00712725|Drug|MK3207- 10 mg|Arm 3: MK3207 10 mg taken after migraine onset.
16290601|NCT00712725|Drug|MK3207- 20 mg|Arm 4: MK3207 20 mg taken after migraine onset.
16290602|NCT00712725|Drug|MK3207- 50 mg|Arm 5: MK3207 50 mg taken after migraine onset.
16290603|NCT00712725|Drug|MK3207- 100 mg|Arm 6: MK3207 100 mg taken after migraine onset.
16290604|NCT00712725|Drug|Comparator: placebo (unspecified)|Placebo taken after migraine onset.
16290605|NCT00712712|Drug|Acetaminophen|Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
16290607|NCT00712712|Other|Questionnaire administration|"Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :
~The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital,
~the background morphine analgesic treatment during the last 24 hours,
~the morphine analgesic treatment taken during painful attacks,
~the possible undesirable effects of morphine treatment.
~the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent"
16290608|NCT00712712|Procedure|Quality-of-life assessment|Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.
16290609|NCT00712712|Procedure|Radiofrequency ablation|"Recent technique of thermal destruction of tumors.
~This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser).
~Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz."
16290610|NCT00712699|Drug|Sequence 1: XR-MAS then placebo|XR-MAS given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
16290611|NCT00712699|Drug|Sequence 2 Placebo then XR-MAS|PBO given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
16290612|NCT00712686|Drug|Aripiprazole|Tablets, Oral, 15-30 mg, once daily, 140 weeks
16290613|NCT00712686|Drug|Olanzapine|Capsule, Oral, 10-20 mg, once daily, 140 weeks
16290614|NCT00712673|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).
16290615|NCT00712673|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).
16290616|NCT00712673|Device|Pen auto-injector|
16290617|NCT00712673|Drug|Metformin|Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.
16290618|NCT00712660|Drug|antipsychotic dose increase|20% increase in the dose of current antipsychotic medication
16290619|NCT00712660|Other|no intervention|Treatment as usual
16290620|NCT00712647|Drug|Beta Carotene and Retinol|"Pilot participants (ppts):
~Asbestos-Exposed--15 mg/day beta-carotene + 25,000 IU/day retinol Heavy Smokers--30 mg/day beta-carotene + 25,000 IU/day retinol
~Vanguard & Efficacy ppts:
~Asbestos-exposed AND heavy smokers--30 mg/day beta-carotene + 25,000 IU/day retinol"
16290621|NCT00712647|Other|Placebo|Two placebos, one each/day
16290622|NCT00712634|Biological|CMVpp65-A*0201 peptide vaccine|Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90
16290623|NCT00712621|Behavioral|Counseling|• Arm II: Patients receive audio visual aids and weekly counseling sessions by the expert counselors and breast cancer survivors over 8 weeks for a total of 8-16 sessions. Patients receive written materials from the counseling group after the completion of the sessions
16290624|NCT00712621|Behavioral|Written materials|• Arm I: Patients receive the support by providing existing resources. Patients receive standard written materials from the counseling group after enrolling in the study.
16290625|NCT00712608|Other|Infant formula|Marketed cow's milk base infant formula 20 kcal/oz
16290626|NCT00712608|Other|Infant formula|cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
16290627|NCT00712608|Other|Cow's milk infant formula|Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
16290628|NCT00712595|Drug|Mifepristone|Oral administration of Mifepristone 10 mg daily for three months
16290629|NCT00712595|Drug|Mifepristone|Oral administration of Mifepristone 5 mg, daily for three months
16290630|NCT00712582|Drug|Etoposide, carboplatin, ifosfamide|Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
16290631|NCT00712582|Drug|Rituximab, Ifosfamide, Etoposide, Carboplatin|It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
16290632|NCT00712582|Drug|Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine|"It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
~Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital."
16290633|NCT00712569|Behavioral|questionnaires|Patients in Category 1 are those who report before the visit that they intend to discuss cancer-related internet information and report after the visit that they did discuss such information. The coding of these patients' consultations with their physicians and analysis of their pre- and post-consultation questionnaires will address Aims 1 and 2.
16290634|NCT00712569|Behavioral|audio recordings , questionnaires|"Patients in Category 2 are those who report before the visit that they intend to discuss cancer-related internet information, but report after the visit that they did not discuss such information. This category is important as our previous research indicates that sometimes patients do not discuss information because they feel there is not enough time or because the information is irrelevant or repetitive. These patients' audio recordings will be checked to verify that there was no internet information discussion. These audio recordings will not be coded.
~However, assessment of these patients' questionnaires will aid in addressing Aim 3 and may provide some pilot data on why patients who initially intend to discuss internet information do not."
16290719|NCT00711997|Biological|DTA-H19|Cohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks
16290720|NCT00711984|Device|Herkulink renal artery Stent|renal artery stent
16290725|NCT00711958|Drug|HX575, solution for injection (s.c.)|1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
16290635|NCT00712569|Behavioral|audio recorded questionnaires|Patients in Category 3 are those who report before the visit that they do not intend to discuss cancer-related internet information and do not discuss it. Assessment of these patients' questionnaires will aid in addressing Aim 3. These audio recordings will not be coded. It is important, however, that these consultations be audio recorded for two reasons: First, it allows the physician to remain blinded to the intent of the patient to discuss internet information. Second, it provides a method of verifying that the patient really did not discuss internet information. Although not expected, it is possible for a patient to go into a consultation without intending to discuss internet information, but does end up discussing it. We will note if this occurs.
16290636|NCT00712556|Radiation|fluorine 18-fludeoxyglucose positron emission tomography|fluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors
16290637|NCT00712543|Drug|lactulose (Kristalose®)|Crystals to be dissolved in water and taken as prescribed.
16290638|NCT00712543|Drug|liquid lactulose|Liquid to be taken as prescribed.
16290639|NCT00712530|Biological|DermaVir|DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.
16290640|NCT00712530|Drug|HAART|Three or more antiretroviral drugs that can fully suppress HIV RNA
16290641|NCT00712517|Drug|propofol|propofol anesthesia 3-5mg/kg
16290642|NCT00712517|Drug|sevoflurane|sevoflurane anesthesia
16290643|NCT00712504|Drug|sunitinib|25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)
16290644|NCT00712504|Drug|docetaxel|60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion
16290645|NCT00712491|Drug|Sirolimus|Three subconjunctival injections of 1320 micrograms sirolimus each.
16290646|NCT00712491|Drug|Sirolimus|Three intravitreal injections of 352 micrograms sirolimus each.
16290647|NCT00712478|Drug|insulin|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16290648|NCT00712465|Drug|AZD1305|Extended Release tablet, repeated administration
16290649|NCT00712465|Drug|Digoxin|Tablet, repeated administration
16290650|NCT00712452|Other|Biology and ultrasonography after chemotherapy|Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
16290651|NCT00712452|Other|Biology and ultrasonography after chemotherapy|Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
16290652|NCT00712452|Other|Biology and ultrasonography after chemotherapy|Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
16290653|NCT00712439|Drug|Gabapentin Extended Release tablets|
16290654|NCT00712439|Drug|Placebo|
16290655|NCT00712426|Drug|Creatine Monohydrate|Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
16290656|NCT00712426|Drug|Placebo|Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
16290657|NCT00712413|Drug|OBMT|Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of Pylera, in addition to 1 omeprazole twice daily
16290658|NCT00712400|Drug|Latanoprost 0.005%, Xalatan®|Substance: Latanoprost 0.005%, Xalatan® (Pharmacia Austria Ges.m.b.H. Oberlaaer Straße 251, 1101 Vienna) Dosage form: topical application in one eye Dosage: 1 drop in the evening for 14 days
16290659|NCT00712400|Drug|Placebo|Substance: Vehicle to latanoprost (eyedrops containing the same stabilizers as latanoprost, but no active drug) Dosage form: topical application in one eye Dosage: 1 drop in the evening for 14 days
16290660|NCT00712387|Behavioral|LapSim simulator|Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency
16290661|NCT00712374|Drug|sulfadoxine-pyrimethamine plus amodiaquine|"SP+AQ on three occasions during the malaria transmission season
~Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine"
16290662|NCT00712361|Device|Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)|Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.
16290663|NCT00712348|Drug|Taliglucerase alfa|Intravenous infusion every 2 weeks
16290664|NCT00712335|Drug|Fluticasone Propionate|DPI 250 mcg BID for 3 weeks
16290665|NCT00712335|Drug|Montelukast|PO 10 mg QHS for 3 weeks
16290666|NCT00712335|Drug|Salmeterol|DPI 50mg BID for 3 weeks
16290667|NCT00712322|Drug|Darifenacin|(0.030 mg/kg/day)
16290668|NCT00712322|Drug|Darifenacin|(0.0625 mg/kg/day)
16290669|NCT00712322|Drug|Darifenacin|(0.125 mg/kg/day)
16290670|NCT00712322|Drug|Darifenacin|(0.250 mg/kg/day)
16290671|NCT00712309|Device|Lifestent|Stent for endovascular treatment of popliteal artery lesions
16290672|NCT00712309|Device|balloon-angioplasty (PTA)|PTA for endovascular treatment of popliteal artery lesions
16290673|NCT00712296|Drug|ASHMI 4|4 capsules orally twice a day
16290674|NCT00712296|Drug|ASHMI 12|12 capsules orally twice a day
16290675|NCT00712296|Drug|Placebo|Placebo 6 capsules twice a day
16290676|NCT00712283|Drug|Neramexane mesylate|tablets Group A: duration: 12,5 mg for 7 days and 25 mg for 8 days Group B: duration: 25 mg for 7 days and 50 mg for 8 days Group C: duration: 50 mg for 7 days and 75 mg for 8 days Group D: duration: placebo for 15 days
16290721|NCT00711984|Other|best medical therapy|All patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification
16290722|NCT00711971|Drug|EPA-rich fish oil supplement|1060 mg EPA plus 274 mg DHA
16290723|NCT00711971|Drug|DHA-rich fish oil supplement|900 mg DHA plus 180 mg EPA
16290724|NCT00711971|Drug|placebo|control arm
16290677|NCT00712270|Drug|Aripiprazole|Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
16290678|NCT00712270|Drug|Risperidone|Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
16290679|NCT00712257|Device|Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface|treatment for superficial femoral artery instent re-stenosis
16290680|NCT00712244|Device|DisCoVisc|Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
16290681|NCT00712244|Device|DuoVisc|Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
16290682|NCT00712244|Device|Healon5|Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
16290683|NCT00712244|Device|Amvisc Plus|Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.
16290684|NCT00712218|Procedure|No Lymphadenectomy (LNE)|No lymphadenectomy is performed in patients of the control group
16290685|NCT00712218|Procedure|Lymphadenectomy (LNE)|Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions [24, ].
16290686|NCT00712205|Drug|Placebo|once daily 1mcg Placebo for 28days followed by crossover treatment
16290687|NCT00712205|Drug|Calcitriol|once daily 1mcg Calcitriol / Placebo for 28days followed by crossover treatment
16290688|NCT00712192|Procedure|coronary artery bypass grafting|patient with coroary artery diseases underwent coronary artery bypass grafting surgery
16290689|NCT00712166|Drug|AZLI 75 mg three times daily (TID)|
16290690|NCT00712166|Drug|Placebo three times daily (TID)|
16290691|NCT00712140|Biological|trastuzumab|Given IV
16290692|NCT00712140|Drug|parenteral chemotherapy|per the local institutional protocols either concurrently with or sequentially to trastuzumab
16290693|NCT00712127|Other|Diet and Exercise|The participants in this intervention will receive 12 months of weight loss through diet and exercise
16290694|NCT00712127|Other|Diet and Exercise-Delayed|Participants in this intervention will receive six months of weight loss through diet followed by six months of diet and exercise
16290695|NCT00712114|Drug|HE3286|HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.
16290696|NCT00712114|Drug|HE3286|HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days
16290697|NCT00712114|Drug|HE3286|HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days
16290698|NCT00712101|Drug|abciximab intracoronary|administer abciximab bolus intracoronary during primary percutaneous coronary intervention
16290699|NCT00712101|Drug|abciximab intravenously|administer abciximab bolus intravenously during primary percutaneous coronary intervention
16290700|NCT00712088|Behavioral|Project ICARE|Group-level intervention (Project ICARE)
16290701|NCT00712088|Behavioral|HCT|Offer of HIV counseling and testing
16290702|NCT00712075|Behavioral|CBSST+PDA|PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
16290703|NCT00712075|Behavioral|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
16290704|NCT00712075|Behavioral|PDA-only|To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
16290705|NCT00712062|Drug|Pemetrexed|500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
16290706|NCT00712049|Drug|simvastatin|simvastatin 40 mg
16290707|NCT00712049|Drug|Nicotinic Acid|daily dose starting with 500 mg, up to 2000mg
16290708|NCT00712036|Behavioral|Interim|Methadone maintenance with emergency counseling only for up to 4 months
16290709|NCT00712036|Behavioral|Comprehensive|Methadone treatment with counseling as usual
16290710|NCT00712036|Behavioral|Restored|Methadone maintenance with counseling provided by a clinician with a lower than usual caseload
16290711|NCT00712023|Device|warming device (a reusable, custom-made forced- air warming mattress)|"2=forced-air warming mattress
~1=circulating-water mattress"
16290712|NCT00712010|Other|Whey protein native|Whey protein native against the 6 other arms
16290713|NCT00712010|Other|Whey protein microgels|Whey protein microgels versus the six other arms
16290714|NCT00712010|Other|Hydrolyzed whey protein|versus the six other arms
16290715|NCT00712010|Other|Casein native|versus the six other arms
16290726|NCT00711958|Drug|ERYPO®, Janssen-Cilag, solution for injection (s.c.)|1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
16290727|NCT00711919|Drug|Pitavastatin|"comparison of different target levels of lipid lowering using Pitavastatin
~Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months."
16290728|NCT00711919|Drug|Pitavastatin|Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.
16290729|NCT00711906|Drug|Cotrimoxazole|Cotrimoxazole
16290730|NCT00711906|Drug|Sulfadoxine-pyrimethamine|Sulfadoxine-pyrimethamine
16290731|NCT00711893|Device|Cognis 100-D, Teligen DR and VR 100 HE|Teligen is an implantable defibrillator for detection and termination of life threatening arrhythmias. Cognis includes in addition to these capabilities cardiac resynchronization therapy for patients having heart failure.
16290732|NCT00711880|Drug|Sativex®|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290733|NCT00711880|Drug|Placebo|containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
16290734|NCT00711867|Device|VH2|Dynatherm vitalHeat2 (VH2) temperature management system.
16290735|NCT00711867|Device|Bair Hugger|Arizant Bair Hugger temperature management system.
16290736|NCT00711854|Drug|trimethoprim-sulfamethoxazole (TMP-SMX)|TMP-SMX (160 mg TMP/ 800 mg SMX IV or PO 3x daily)
16290737|NCT00711854|Drug|Linezolid|Linezolid (600 mg IV or PO twice daily)
16290738|NCT00711854|Drug|Rifampicin|Rifampicin (600 mg IV or PO once daily)
16290739|NCT00711841|Drug|dexamethasone|Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
16290740|NCT00711841|Drug|Placebo|Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
16290741|NCT00711841|Drug|dexamethasone|dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours
16290742|NCT00711828|Drug|Bortezomib|Given IV
16290743|NCT00711828|Biological|Rituximab|Given IV
16290744|NCT00711828|Drug|Cyclophosphamide|Given PO
16290745|NCT00711828|Drug|Dexamethasone|Given PO
16290746|NCT00711828|Other|Questionnaire Administration|Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)
16290747|NCT00711828|Other|Quality-of-Life Assessment|Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)
16290748|NCT00711802|Drug|Daptomycin|
16290749|NCT00711802|Drug|Standard of Care (SOC)|
16290750|NCT00711789|Drug|Angiotensin II|Angiotensin II will be given by continuous infusion for 24 hours starting at a dose of 5ng/kg/min and then titrated to a maximum dose of 15 ng/kg/min according to a blood pressure based protocol
16290751|NCT00711789|Drug|Saline placebo|Saline placebo will be given by continuous infusion according to a blood-pressure base protocol. This protocol will also incorporate noradrenaline for blood pressure control (as is true in the active drug arm), such that blood pressure targets will be rapidly achieved in both arms of the study; the only difference being that in the active drug arm, at least part of the pressor effect will be provided by angiotensin II.
16290752|NCT00711776|Drug|New formulation|New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
16290753|NCT00711776|Drug|Current formulation|Current formulation of Aciclovir Cream 5% in Japan
16290754|NCT00711711|Other|Manual lymphatic drainage|Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
16290755|NCT00711711|Other|relaxation|Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
16290756|NCT00711698|Procedure|Patient controlled analgesia|Patients in this arm will be treated with a bolus of narcotic followed by PCA
16290757|NCT00711698|Drug|nurse-administered intermittent IV bolus opioid therapy (NAIBOD)|In this arm patients will receive the current standard of care of IV bolus narcotic therapy
16290758|NCT00711685|Procedure|coronary artery bypass grafting via midline sternotomy|
16290759|NCT00711646|Drug|Sativex®|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290760|NCT00711646|Drug|Placebo|containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
16290761|NCT00711633|Dietary Supplement|Milk with probiotic and prebiotic activities|Comparison of two different formula for preterm infants
16290762|NCT00711633|Dietary Supplement|Milk without probiotic and prebiotic activities|Comparison of formula for preterm infants
16290763|NCT00711620|Drug|Thymosin alpha 1|1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.
16290764|NCT00711607|Drug|nomegestrol acetate and estradiol|Group 1: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 and day 35; Group 2: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 followed by one Placebo tablet on day 35
16290765|NCT00711594|Drug|BIBW 2992 MA2 40mg/day|Phase I step: Increased dose cohorts from low dose to MTD
16290766|NCT00711594|Drug|BIBW 2992 MA2 50mg/day|Phase I step: Increased dose cohorts from low dose to MTD
16290767|NCT00711594|Drug|BIBW 2992 MA2 20mg/day|Phase I step: Increased dose cohorts from low dose to MTD
16290768|NCT00711594|Drug|BIBW 2992 QD|Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.
16290769|NCT00711581|Device|Gallbladder retraction|The gallbladder will be retracted using the Endograb retractor
16290770|NCT00711568|Procedure|Repetitive transcranial magnetic stimulation (rTMS)|20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes)
16290771|NCT00711568|Procedure|Sham rTMS|20 Hz sham rTMS delivered to L or R frontal region for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli
16290772|NCT00711568|Device|Repetitive Transcranial Magnetic Stimulator|Repetitive Transcranial Magnetic Stimulator
16290805|NCT00711308|Drug|tinzaparin|tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
16290806|NCT00711308|Drug|acenocoumarol|acenocoumarol for 6 months
16292073|NCT00702117|Drug|procainamide|10 mg/kg iv in 10 minutes
16290773|NCT00711555|Drug|aprepitant, ondansetron, dexamethasone|"On day 1, the subject will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 125mg. On days 2 to THE LAST DAY OF THE MODERATELY-HIGH TO HIGHLY EMETOGENIC CHEMOTHERAPY, subjects will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 80mg. All anti-emetics should be give one hour before starting chemotherapy administration.
~FOR TWO DAYS AFTER RECEIVING CHEMOTHERAPY, the subject will be prescribed oral dexamethasone 4mg every 12 hours and oral aprepitant 80 mg every day.
~FOR RESCUE, the subject will be prescribed prochlorperazine 10 mg oral every 4 hours as needed for nausea and prochlorperazine 10 mg intravenous every 4 hours as needed for vomiting."
16290774|NCT00711542|Biological|autologous bone marrow-derived progenitor cells|intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
16290775|NCT00711542|Biological|placebo medium|intracoronary infusion of placebo medium
16290776|NCT00711529|Behavioral|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. surveys. The therapist will be prohibited from asking subjects about clinical responses to the hypnosis sessions. The patients will also be instructed on self-hypnosis techniques to be used at home.
16290777|NCT00711529|Drug|gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). This dose has been shown to be more effective than 300mg daily. Larger doses have not been evaluated in this population, and may be associated with a more significant side-effect profile. The prescription for gabapentin will be provided at the patient's enrollment appointment. The patients will take gabapentin as prescribed daily for the study-enrollment period, which is 8 weeks.
16290778|NCT00711516|Drug|Armodafinil|Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.
16290779|NCT00711516|Drug|Placebo|Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.
16290780|NCT00711503|Drug|anakinra|The patients are instructed to administer anti-IL-1 therapy in the form of recombinant human non-glycosylated interleukin-1 receptor antagonist (IL-1Ra, anakinra, Kineret®, Amgen, CA, USA) [13] at a dose of 100 mg once daily by subcutaneous injection
16290781|NCT00711503|Drug|saline|The patients are instructed to administer placebo (saline) once daily by subcutaneous injection
16290782|NCT00711490|Drug|Sirolimus|20 μL (440 μg) of sirolimus were injected at baseline, Month 2, and every 2 months thereafter if re-treatment criteria were satisfied.
16290783|NCT00711477|Drug|Naltrexone SR 32 mg/bupropion SR 360 mg/day|
16290784|NCT00711477|Drug|Placebo|
16290785|NCT00711477|Other|fMRI scan|fMRI to assess the effects of the drug/placebo on areas of the brain
16290786|NCT00711464|Drug|modafinil (M1, M2, M4)|modafinil 100, 200, and 400 mg oral dose
16290787|NCT00711451|Behavioral|Manual removal|Manual removal of placenta during cesarean delivery
16290788|NCT00711451|Procedure|Expressed removal|Surgeon will perform an expressed delivery of the placenta
16290789|NCT00711438|Behavioral|Breathlessness Intervention Service (BIS)|BIS consists of a clinical specialist physiotherapist & palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. This BIS seeks to enhance self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs & allied health professionals (with medical consent).
16290790|NCT00711438|Behavioral|Best supportive care (Standard care)|Standard care: specialist outpatient appointments in secondary care (e.g. respiratory) which may include specialist nurse input, and primary care services.
16290791|NCT00711425|Device|OsseoSpeed™|OsseoSpeed™, all dimensions
16290792|NCT00711412|Drug|Induction Therapy - Capecitabine|Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
16290793|NCT00711412|Drug|Induction Therapy - Oxaliplatin|Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
16290794|NCT00711412|Drug|Combination Therapy - Capecitabine|Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
16290795|NCT00711412|Drug|Combination Therapy - Oxaliplatin|Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
16290796|NCT00711412|Radiation|Combination Therapy - Radiation|1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
16290797|NCT00711412|Procedure|Evaluation for response and surgery|Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.
16290798|NCT00711399|Device|PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies|wheeze and cough detection in hospitalized patients.
16290799|NCT00711386|Drug|GSK706769|50mg, 100mg, 200mg, or 400mg
16290800|NCT00711386|Other|Placebo|Placebo
16290801|NCT00711373|Procedure|Allogeneic hand transplantation|Surgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor
16290802|NCT00711360|Device|Intrathoracic impedance measurement|Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)
16290803|NCT00711347|Device|DisCoVisc|Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.
16290804|NCT00711347|Device|Healon5|Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.
16290807|NCT00711295|Biological|H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted|Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
16290808|NCT00711295|Biological|H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted|Intramuscular injection of 3.75 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
16290809|NCT00711282|Device|OsseoSpeed™|OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
16290810|NCT00711282|Device|OsseoSpeed™|OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
16290811|NCT00711269|Drug|SM-13496 (lurasidone HCl)|Lurasidone HCl: 40 mg/day
16290812|NCT00711269|Drug|SM-13496 (lurasidone HCl)|Lurasidone HCl: 80 mg/day
16290813|NCT00711269|Drug|Placebo|
16290814|NCT00711269|Drug|Risperidone|
16290815|NCT00711256|Other|sunscreen MATAS sunlotion SPF 8|
16290816|NCT00711256|Radiation|UVB light|duration 4 times 1 minute radiation on the trunk.
16290817|NCT00711243|Drug|docetaxel|Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
16290818|NCT00711243|Drug|fluorouracil|Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
16290819|NCT00711243|Drug|oxaliplatin|Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
16290820|NCT00711230|Biological|DermaVir|
16290821|NCT00711230|Biological|Placebo|glucose/dextrose
16290822|NCT00711217|Other|Medical Food|twice daily
16290823|NCT00711217|Other|Drink mix calorically similar to experimental product|twice daily
16290824|NCT00711204|Drug|Donepezil Hydrochloride (Aricept)|5mg (or 10mg) tablet, once daily, with a full glass of water.
16290825|NCT00711191|Biological|monoclonal antibody|CP-870,893 intravenous administration [IV] on day 3 of 4-week cycles
16290826|NCT00711191|Drug|chemotherapy|gemcitabine 1000 mg/m^2 intravenous administration [IV] q week [wk]x3 of 4-week cycles
16290827|NCT00711178|Procedure|Photodynamic therapy with methyl aminolevulinate|daylight mediated photodynamic therapy
16290828|NCT00711165|Drug|Placebo|2 puffs, qd
16290829|NCT00711165|Drug|Mometasone Furoate|400 mcg, qd for 8 weeks
16290830|NCT00711152|Other|Protocol-driven care under JADE Program|The JADE Program uses the state of the art of information technology to facilitate evidence-based clinical protocol by a multidisciplinary team. There is an internet on-line and computer record system to facilitate the day-to-day management of people with diabetes.
16290831|NCT00711152|Other|Additional support by CHW|Patients will receive additional support by a trained community health worker (CHW). Guided by the personalized report with embedded decision support, the CHW will reinforce treatment adherence and self care after each clinic visit.
16290832|NCT00711126|Drug|GW642444|2.5mcg IV
16290833|NCT00711126|Drug|GW642444|5mcg IV
16290834|NCT00711126|Drug|GW642444|10mcg IV
16290835|NCT00711126|Drug|GW642444|100mcg inhaled
16290836|NCT00711126|Drug|GW642444|20mcg IV
16290837|NCT00711126|Drug|GW642444|500mcg oral
16290838|NCT00711113|Device|OsseoSpeed™|OsseoSpeed™, all dimensions
16290839|NCT00711100|Other|Camel Snus|All subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase.
16290840|NCT00711100|Other|Marlboro Snus|All subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase.
16290841|NCT00711100|Other|Stonewall|All subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase.
16290842|NCT00711100|Other|Ariva|All subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase.
16290843|NCT00711100|Other|General Snus|All subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase.
16290844|NCT00711087|Drug|BOTOX-A|Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90
16290845|NCT00711087|Other|Saline injection|Group 2-sham saline injections on both Day 0 and Day 90.
16290846|NCT00711074|Drug|AZD5672|single dose 200mg aqueous solution
16290847|NCT00711048|Drug|AZD1386|oral, single dose
16290848|NCT00711048|Drug|Placebo|Oral solution, single dose
16290849|NCT00711035|Biological|Trivirus Specific CTLs for EBV, CMV and Adenovirus Infection|"Follow-up Assessments: The timing of follow-up visits is based on the date of CTL infusion. If a patient has multiple CTL doses the schedule resets again at the beginning so follow up relates to the last CTL dose.
~Follow up will occur at 7 days, 14 days, 21 days, 28 days, 42 days, 90 days, 180 days, and 365 days post enrollment."
16290850|NCT00711022|Device|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.|
16290851|NCT00711009|Drug|lopinavir/ritonavir (LPV/r)|LPV/r 400/100 mg BID
16290852|NCT00711009|Drug|emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)|FTC/TDF 200/300 mg QD
16290853|NCT00711009|Drug|raltegravir (RAL)|RAL 400 mg BID
16290854|NCT00710983|Biological|Oral polio vaccine|
16290933|NCT00710268|Drug|AZD2281|Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing
16290855|NCT00710970|Drug|Tamoxifen|Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
16290856|NCT00710944|Device|ASTRA TECH Implant System, OsseoSpeed™|ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
16290857|NCT00710931|Device|AcrySof ReSTOR Aspheric IOL model SN6AD1|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.
16290858|NCT00710905|Device|AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.
16290859|NCT00710892|Biological|Allodepleted T Cells|"Dose Level 1 = 1 x 10e6 T cells/kg; Dose Level 2 = 3 x 10e6 T cells/kg; Dose Level 3 = 1 x 10e7 T cells/kg.
~Patients may be enrolled at the next dose level of T cells when all patients at the previous dose level have reached Day 42 post-T cell infusion without unacceptable toxicity."
16290860|NCT00710879|Device|Bausch & Lomb Multi-Purpose Solution|Daily care for contact lenses.
16290861|NCT00710866|Biological|Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)|Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.
16290862|NCT00710853|Other|YiRen Qi gong|One hour weekly class for 8 week duration
16290863|NCT00710853|Other|Tai Chi|One hour weekly class for 8 week duration
16290864|NCT00710853|Other|Hatha yoga|One hour weekly class for 8 week duration
16290865|NCT00710840|Procedure|Minimally Invasive Total Knee Arthroplasty [TKA Min]|TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
16290866|NCT00710840|Procedure|Total Knee Arthroplasty (TKA) Traditional|TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
16290867|NCT00710827|Drug|NEBIDO|Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)
16290868|NCT00710827|Drug|PLACEBO|Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)
16290869|NCT00710814|Drug|Leptin|Leptin self-administered subcutaneously at 0.05 mg/kg body weight twice each day
16290870|NCT00710814|Other|Placebo|Sterile water equal in volume to that of the metreleptin dose calculated for each individual self-administered subcutaneously twice each day
16290871|NCT00710788|Drug|sevelamer phosphate-binders|1600 mg/day for 2 years
16290872|NCT00710788|Drug|Calcium Carbonate|Calcium carbonate 1 g/day for 2 years
16290873|NCT00710775|Procedure|surgical replacement of the aortic stenotic valve|Prior to surgical removal of the aortic valve, the native valve will be dilated under direct vision of the surgeon using a standard valve dilation balloon. The HLT valve will be loaded into a short version of the delivery catheter system and the catheter will be passed across the native valve.Measurements will be taken of the device relative to the anatomic structures of the heart. Once complete, the implant is removed from the native valve and the surgical valve replacement procedure is completed.
16290874|NCT00710762|Drug|BIBF1120|
16290875|NCT00710762|Drug|Placebo|
16290876|NCT00710749|Device|Disposable device|Disposable urine flow meter
16290877|NCT00710749|Device|Digital device|Digital urine flowmeter
16290878|NCT00710749|Device|Clinic flow measurement|Clinic gold standard flow measurement
16290879|NCT00710736|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|multiple dose, escalating
16290880|NCT00710736|Drug|Capecitabine, 5-fluorouracil prodrug; oral|multiple dose, single schedule
16290881|NCT00710723|Procedure|vitrification|Vitrification using Hemi-straw carrier system.
16290882|NCT00710710|Drug|BI 2536|
16290883|NCT00710697|Drug|Picoplatin|IV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16290884|NCT00710684|Drug|SB-742457 15mg|SB-742457 - 15mg added to existing donepezil treatment
16290885|NCT00710684|Drug|SB-742457 35mg|SB-742457 - 35mg added to existing donepezil
16290886|NCT00710684|Drug|Placebo|Placebo added to existing donepezil
16290887|NCT00710684|Drug|donepezil 5-10mg|existing donepezil treatment
16290888|NCT00710658|Behavioral|WebChoice|"Patients in the experimental group had over the study period access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.
~Patients in the control group received usual care"
16290889|NCT00710645|Device|Lido Workset|The intervention will consist of spasticity testing on the Lido Workset device. The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
16290890|NCT00710632|Other|laboratory biomarker analysis|
16290891|NCT00710632|Other|physiologic testing|
16290892|NCT00710632|Other|questionnaire administration|
16290893|NCT00710632|Procedure|management of therapy complications|
16290894|NCT00710619|Drug|activated recombinant human factor VII|This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
16290895|NCT00710619|Drug|Feiba VH|This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors
16290896|NCT00710606|Drug|NuvaRing|Obese subjects (BMI 30-39.9) will receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
16290934|NCT00710268|Drug|Bevacizumab|IV administration10 mg/kg every 14 days
16290935|NCT00710255|Procedure|Hyperpnea challenge|5 minutes of dry air hyperpnea to induce bronchospasm
16290897|NCT00710606|Drug|NuvaRing|Normal weight subjects will also receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
16290898|NCT00710593|Biological|HPV vaccine for strains -6, -11, -16, and -18|All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
16290899|NCT00710580|Biological|ABT-874|SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
16290900|NCT00710580|Biological|etanercept|SQ injection 50 mg BIW
16290901|NCT00710580|Drug|placebo|SQ placebo injections for ABT-874 and etanercept
16290902|NCT00710567|Device|DuraHeart Left Ventricular Assist System (LVAS)|The DuraHeart LVAS is implanted in using open heart surgery
16290903|NCT00710554|Drug|Sativex|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290904|NCT00710554|Drug|Placebo|containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
16290905|NCT00710541|Device|ventilators designed for non invasive ventilation|Patients are advised to use the ventilator for non invasive ventilation as long term treatment for at least 6 hours per day over one year.
16290906|NCT00710528|Drug|CAL-101|CAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days
16290907|NCT00710515|Drug|AZD6244|75mg
16290908|NCT00710502|Procedure|Transvaginal NOTES cholecystectomy|Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
16290909|NCT00710502|Procedure|Laparoscopic cholecystectomy|Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
16290910|NCT00710476|Procedure|Insemination|Insemination with a lower concentration of spermatozoa: 150 000 spermatozoa/ml
16290911|NCT00710463|Device|non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)|non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.
16290912|NCT00710437|Drug|Dexmedetomidine|Steady state infusion 0.007 mcg/kg/min
16290913|NCT00710424|Drug|Sativex|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
16290914|NCT00710424|Drug|Placebo|containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
16290915|NCT00710398|Behavioral|Exercise - Aerobic and Resistance|Subjects will perform exercise (aerobic and resistance) 7d/wk and will exercise supervised 5d/wk. Exercise will be carried out to expend 250 kcals/day. Supervised resistance training sessions will take place 2 days/wk and aerobic exercise will take place every day. During the resistance exercise sessions, subjects will engage in a circuit weightlifting routine using guided motion machines. During the aerobic sessions, subjects may choose whatever exercise modality they like (e.g. walking on track or treadmill, biking, elliptical, etc.). Subjects will wear devices that measure energy expenditure to get a better idea of the intensity and duration needed to expend 250 kcals with their exercise machine/modality of choice.
16290916|NCT00710398|Behavioral|Dietary - Caloric Restriction|"Subjects will be counselled on their respective hypocaloric diets during the 16 wk period. Adherence to the prescribed diet will be assessed via collection of assigned food records (biweekly), frequent contact with subjects, and regular dietary counseling sessions. The daily dietary energy deficit will be 500 kcal per day based on the subjects' estimated daily caloric requirements (based on height, weight, age, sex), multiplied by a sedentary activity factor.
~Additionally, subjects will consume 2 drinks per day that will differ depending on their randomization allocation. Subjects in the Dairy Protein and High Dairy Protein group will be provided with dairy products (e.g. milk, cheese, yogurt) to consume on a weekly basis to help facilitate their prescribed dairy and dietary protein intake."
16290917|NCT00710385|Drug|Heroin|Heroin (25 mg)
16290918|NCT00710385|Drug|Naloxone|.4 mg
16290919|NCT00710385|Drug|Low Bup Dose|4 and 8 mg
16290920|NCT00710385|Drug|High Bup Dose|8mg and 16 mg
16290921|NCT00710385|Drug|Low Bup/Nal Dose|Buprenorphine/Naloxone 4/1 mg, 8/2 mg
16290922|NCT00710385|Drug|High Bup/Nal Dose|Buprenorphine/Naloxone 8/2 mg, 16/4 mg
16290923|NCT00710385|Drug|Placebo (PCB)|Placebo control administration
16290924|NCT00710372|Biological|CYT006-AngQb|s.c. injection
16290925|NCT00710359|Dietary Supplement|Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)|400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
16290926|NCT00710333|Drug|Avotermin|10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability.
16290927|NCT00710333|Drug|placebo|placebo
16290928|NCT00710320|Procedure|Covered and uncovered anesthesia induction|"We hypothesize that the core temperatures of:
~the covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
~both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group."
16290929|NCT00710307|Procedure|Blood sampling|Blood samples will be collected at visit 1 (day 1) and at visit 2 (day 14 to 45).
16290930|NCT00710307|Genetic|Genetic analysis|The sample for genetic analyses may be taken at Visit 1. The blood sample volume will be 6 mL.
16290931|NCT00710294|Device|CVRx Rheos Baroreflex Hypertension Therapy System|"The pulse generator, which is similar to a pacemaker, is typically implanted under the skin below the collarbone.
~Two small leads from the device are wrapped around the carotid arteries on both sides of the neck and connected to the pulse generator."
16290932|NCT00710281|Radiation|Additional scan time on standard MR angiography|"Procedure/Surgery: Additional 5 minutes scan time to standard MR angiography
~Using the Nova® Software, an additional 5 minutes scan time will be required in order to identify aneurysm, select target artery, and complete measurements
~Arms:"
16290936|NCT00710242|Drug|DF01|Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)
16290937|NCT00710242|Drug|Placebo|Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)
16290938|NCT00710229|Drug|Ranibizumab|intravitreal injection
16290939|NCT00710229|Drug|Bevacizumab|intravitreal injection
16290940|NCT00710216|Drug|Lamivudine|100 mg/day
16290941|NCT00710216|Drug|Telbivudine|600 mg/day
16290942|NCT00710203|Device|Pulsed dye laser|One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
16290943|NCT00710203|Procedure|Curettage|A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
16290944|NCT00710203|Procedure|Electrodesiccation|A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
16290945|NCT00710203|Other|No treatment|A fourth lesion will not be treated and will serve as a control.
16290946|NCT00710190|Device|Rheos Baroreflex Hypertension Therapy System|This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.
16290947|NCT00710164|Drug|XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)|14 days of XSCR capsule
16290948|NCT00710164|Drug|Placebo|14 days of Placebo
16290949|NCT00710138|Dietary Supplement|Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)|400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
16290950|NCT00710125|Drug|GPX-150 for Injection|Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment. Patients who have previously received an anthracycline are limited to 4 cycles of treatment.
16290951|NCT00710112|Genetic|gene variations|comparing variations in genes in infants who develop chronic lung disease and other diseases of prematurity and those who do not.
16290952|NCT00710099|Drug|sildenafil|systemic absorption of sildenafil
16290953|NCT00710099|Drug|nitroprussiate iontophoresis|nitroprussiate iontophoresis
16290954|NCT00710086|Drug|Hydromorphone|Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
16290955|NCT00710086|Drug|Remifentanil|Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
16290956|NCT00710073|Device|sono-electro-magnetic therapy (Sonodyn Medico Star)|twice a day for 10 minutes during 6 or 12 weeks
16290957|NCT00710060|Behavioral|Community Popular Opinion Leader (C-POL)|The C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts.
16290958|NCT00710060|Behavioral|HIV/STD educational materials|Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
16290959|NCT00710047|Drug|ZD4054|one single 10mg dose
16290960|NCT00710034|Other|Oral tobacco|Snus
16290961|NCT00710034|Drug|Nicotine Gum|4 mg Nicotine gum
16290962|NCT00710021|Drug|Vitamin D3|8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
16290963|NCT00710021|Drug|Vitamin D3 placebo|86% microcrystalline cellulose, 14% fumed silica by weight
16290964|NCT00710008|Other|exercise training|3 bouts of exercise at 90%RCP during one week
16290965|NCT00709995|Drug|Enzastaurin|Administered orally
16290966|NCT00709995|Drug|Sunitinib|Administered orally
16290967|NCT00709995|Drug|Placebo|Administered orally
16290968|NCT00709982|Drug|Norgestimate; Ethinyl Estradiol; Folic acid|
16290969|NCT00709969|Drug|Artemether-lumefantrine|20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - < 10kg (BWG 1) = 6 doses of 1 tablet / 10 - < 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets
16290970|NCT00709956|Drug|iloprost (5 µg)|Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
16290971|NCT00709956|Drug|placebo|Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
16290972|NCT00709930|Device|Magnetic field generator|dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month
16290973|NCT00709930|Device|Placebo magnetic field generator|Placebo device with no magnetic fields
16290974|NCT00709917|Drug|repaglinide|Start dose and freqency to be prescribed by the physician at his discretion following clinical practice
16290975|NCT00709904|Drug|Open-label Semuloparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection once daily with an initial dose given 8 hours after surgery"
16290976|NCT00709904|Drug|Placebo (for Semuloparin sodium)|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection once daily"
16290977|NCT00709904|Drug|Semuloparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection once daily"
16290978|NCT00709891|Device|cobas® 4800 HPV Test|
16290979|NCT00709878|Procedure|Skin Biopsy of Skin Rash Secondary to EGFRI Use|Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.
16290980|NCT00709865|Drug|tonapofylline|IV
16290981|NCT00709865|Drug|Placebo|IV
16290982|NCT00709852|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
16290983|NCT00709852|Drug|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
16292074|NCT00702104|Other|survey administration|
16290984|NCT00709839|Drug|Hydrocortisone|0.6 mg/kg body weight, intravenous bolus given at time-point minus 4'
16290985|NCT00709839|Drug|Glucose 33%|1ml/kg body weight, intravenous bolus given at time-point 0'
16290986|NCT00709826|Drug|gemcitabine|Gemcitabine: per package insert.
16290987|NCT00709826|Drug|placebo|placebo: 100 mg tablets, 400 mg/day
16290988|NCT00709826|Drug|Erlotinib|Erlotinib - per package insert.
16290989|NCT00709826|Drug|apricoxib|apricoxib: 100mg tablets, given orally
16290990|NCT00709813|Behavioral|Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))|Both groups used CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)for symptom assessments at in- and outpatient visits during and up-to nine months after treatment. In the intervention group physicians and nurses had assessment summaries available for care planning, displaying patients' symptoms, problems and concerns in rank-order of their needs for care. In the control group assessments were not available to care providers at any time.
16290991|NCT00709800|Biological|VCL-IPT1|IM, 0.1 mg/mL, 2 injections, 0 and 21 days
16290992|NCT00709800|Biological|VCL-IPT1|IM, 0.5 mg/mL, 2 injections, 0 and 21 days
16290993|NCT00709800|Biological|VCL-IPT1|IM, 1 mg/mL, 2 injections, 0 and 21 days
16290994|NCT00709800|Biological|VCL-IPM1|IM, 1 mg/mL, 2 injections, 0 and 21 days
16290995|NCT00709800|Biological|PBS|IM, 1 mL, 2 injections, 0 and 21 days
16290996|NCT00709787|Other|Usual Care|Normal care for hypertensive patients with risk factors for CHD
16290997|NCT00709774|Device|Pacemaker Implantation|Implantation of right ventricular lead at septal or apex.
16290998|NCT00709761|Drug|Lapatinib/nab-Paclitaxel|This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib (TYKERB) in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously on Day 1, 8, 15, every 28 days (q28) days plus lapatinib (1000 mg once daily on a continuous basis).
16290999|NCT00709748|Device|Empi Select TENS Device|The Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain.
16291000|NCT00709748|Device|Placebo|Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
16291001|NCT00709735|Drug|Propranolol|0.67 mg/kg short-acting propranolol combined with 1 mg/kg long-acting propranolol
16291002|NCT00709735|Drug|Placebo|Placebo (matching propranolol) short-acting and long-acting capsules
16291003|NCT00709722|Drug|NKT-01|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
16291004|NCT00709709|Procedure|multislice coronary scan|multislice coronary scan
16291005|NCT00709696|Drug|Placebo|Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
16291006|NCT00709696|Drug|Varenicline|Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
16291007|NCT00709683|Drug|biphasic insulin aspart 30|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16291008|NCT00709670|Procedure|MSCT and stress echocardiography|tests MSCT and stress echocardiography
16291009|NCT00709657|Drug|ranibizumab, bevacizumab or pegaptanib|measurements are performed one week before and after anti-VEGF intravitreal injection
16291010|NCT00709644|Drug|Norgestimate; Ethinyl Estradiol; Folic acid.|
16291011|NCT00709618|Drug|Lapatinib, Vinorelbine|Vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily
16291012|NCT00709605|Drug|VRC-HIVADV014-00-VP|
16291013|NCT00709592|Biological|Thymoglobulin|Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.
16291014|NCT00709592|Radiation|Total-Body Irradiation|Undergo TBI
16291015|NCT00709592|Procedure|Allogeneic PBSCT or BMT|Undergo allogeneic PBSCT or BMT
16291016|NCT00709592|Drug|Tacrolimus|Given PO
16291017|NCT00709592|Drug|Mycophenolate Mofetil|Given PO
16291018|NCT00709579|Drug|RV3391A|A standardized quantity of each product will be applied on the evening on anterior side of forearm. The side of application will be randomized.
16291019|NCT00709579|Drug|Placebo|placebo
16291020|NCT00709566|Behavioral|Exercise therapy|Participants will attend an exercise based programme once a week for 8 weeks. This will be supplemented by a home based exercise programme.
16291021|NCT00709566|Behavioral|Combined exercise and manual therapy|Patients will attend physiotherapy once a week for 8 weeks, where they will receive a combination of exercise therapy and manual therapy. Exercise will be supplemented by a home based exercise programme
16291022|NCT00709553|Drug|midazolam|
16291023|NCT00709553|Drug|ZD4054|ZD4054 10 mg od
16291024|NCT00709540|Biological|ACE-011 or placebo|multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)
16291025|NCT00709527|Drug|ARC1905|intravitreal injection
16291026|NCT00709514|Drug|DCB-WH1 ointment|DCB-WH1 ointment (1.25%), topically applied twice daily
16291027|NCT00709514|Drug|Placebo|Placebo
16291028|NCT00709501|Behavioral|Disseminating Effective Habits for Long-term Weight Loss|Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
16291029|NCT00709501|Behavioral|Achieve Together website|access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
16291030|NCT00709488|Drug|Talaporfin sodium|LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
16291031|NCT00709488|Procedure|Placement of device in prostate urethra|Placement of device in prostate urethra
16291067|NCT00709254|Drug|3 mL AeroLEF (500 µg/1 mL)|A multiple doses of 3mL (500 µg/1 mL)of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)every 12 hours for a total of five doses over a 3 days
16291068|NCT00709228|Drug|PegIntron|1.5 ug/kg/week
16291069|NCT00709228|Drug|Rebetol|800-1200 mg/day
16291874|NCT00703300|Other|laboratory biomarker analysis|Optional correlative studies
16291032|NCT00709488|Device|Transurethral illumination with light emitting diodes (Litx™ BPH Device)|Patients in Cohort A will receive 50 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort B will receive 70 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort C will receive 100 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort D will receive 100 J of light treatment (with the active light emitting length increased from 10mm to 20 mm) with 1 mg/kg LS11 administration.
16291033|NCT00709475|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16291034|NCT00709462|Biological|CDX1307|
16291035|NCT00709449|Drug|moxaverine|intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
16291036|NCT00709449|Drug|moxaverine|intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
16291037|NCT00709449|Drug|moxaverine|intravenous infusion of 150 mg in 250 ml NaCl, applied over 30 minutes.
16291038|NCT00709436|Drug|PMI-150 (intranasal ketamine)|PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
16291039|NCT00709436|Drug|Placebo|Placebo (intranasal) at time 0 and scheduled times thereafter.
16291040|NCT00709423|Drug|Moxaverine|
16291041|NCT00709423|Drug|Moxaverin 150mg|intravenous administration
16291042|NCT00709423|Drug|NaCl|intravenous administration
16291043|NCT00709410|Biological|rBS-WC vaccine|1 mg of recombinant cholera toxin B subunit and approximately 1 x 10^11 of inactivated whole cells of Vibrio cholerae O1 Inaba and Ogawa, classic and El Tor strains (6). The rBS-WC vaccine is supplied as 3 ml single-dose vials each with a sachet of sodium bicarbonate buffer. Buffer solution will be prepared by dissolving the sachets in drinking water (150 ml water for each sachet of sodium bicarbonate). The full dose of vaccine will be mixed with 40, 75, or 150 ml of buffer solution for persons 2 to 4 years, 5 to 11 years, and over 11 years old, respectively. The vaccine is recommended to be given in two doses with an interval of at least seven days and protection is conferred 7 to 10 days after the second dose.
16291044|NCT00709397|Other|blood drawing|Subjects will have been prescribed raltegravir (400 mg BID) by their primary physicians. Such subjects will have frequent blood sampling in this study to monitor the virologic response to raltegravir therapy.
16291045|NCT00709384|Procedure|Prophylactic surgical lesion|A prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy (surgical dissection plus cryoablation) and the atriotomy with the inferior caval vein (cryoablation alone).
16291046|NCT00709371|Drug|Zonisamide SR placebo/ bupropion SR placebo|2 placebo combination tablets twice daily for 16 weeks (maintenance period)
16291047|NCT00709371|Drug|Zonisamide SR placebo/ bupropion SR 360 mg/day|2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
16291048|NCT00709371|Drug|Zonisamide SR 120 mg/day/ bupropion SR placebo|2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
16291049|NCT00709371|Drug|Zonisamide SR 360 mg/day/ bupropion SR placebo|2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
16291050|NCT00709371|Drug|Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day|2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
16291051|NCT00709371|Drug|Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day|2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
16291052|NCT00709358|Other|Detection of microbial DNA in blood by SeptiFast®|"The LightCycler® SeptiFast Test, the innovative real-time PCR test from Roche Diagnostics, is designed to detect and identify the 25 most important bacterial and fungal species causing bloodstream infections within just a few hours. The LightCycler® SeptiFast Test detects the pathogenic bacteria and fungi directly from whole blood without the need for prior incubation or culture steps.
~Rapid detection and identification of bacterial and fungal DNA, directly from a 1.5 ml whole blood sample, without prior incubation or culture steps in less than 6 hours."
16291053|NCT00709358|Other|detection of microbial DNA in blood by blood culture|A blood culture is a test to find an infection in the blood. Most bacteria can be seen in the culture in 2 to 3 days, but some types can take 10 days or longer to show up. Fungus can take up to 30 days to show up in the culture.
16291054|NCT00709345|Behavioral|Cognitive behavioral sessions|Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on promoting healthy behaviors, dieting, and exercise.
16291055|NCT00709345|Behavioral|Time-matched attention control sessions|Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts.
16291056|NCT00709332|Drug|Norgestimate; Ethinyl Estradiol; Folic acid|
16291057|NCT00709306|Device|UV-Detect Photos|UV-Detect Photos
16291058|NCT00709306|Behavioral|Motivational Interviewing|Motivational Interviewing
16291059|NCT00709306|Behavioral|Education|Education
16291060|NCT00709293|Drug|Anti-Thymocyte Globulin|Thymoglobulin (1.5 mg/kg body weight) will be infused through a peripheral intravenous line over a minimum of 6 hours. The infusion will be started at the time of donor visualization (once it is confirmed the transplant is proceeding). The peri-operative nurse or anesthesiologist will be responsible for drug infusion.
16291061|NCT00709293|Drug|Normal Saline|Normal saline will be utilized as a placebo comparator. It will be infused in the same fashion as the Thymoglobulin in the intervention arm.
16291062|NCT00709280|Drug|7% Hypertonic Saline (HS)|Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.
16291063|NCT00709280|Drug|0.9% Isotonic Saline (IS)|Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.
16291064|NCT00709267|Drug|Folic acid|
16291065|NCT00709254|Drug|i.v. fentanyl|single dose, 200 ug
16291066|NCT00709254|Drug|3 mL AeroLEF (500 µg/1 mL)|A single dose of 3mL (500 µg/1 mL) of AeroLEF (Aerosolized Free and Liposome-Encapsulated Fentanyl)
16291140|NCT00708604|Procedure|Islet Transplantation|Islet Transplantation
16291070|NCT00709215|Drug|Cordycepin plus Pentostatin|Cordycepin Plus Pentostatin on days 1, 2 and 3 of a 21 day cycle. Number of cycles until progression or unacceptable toxicity
16291071|NCT00709202|Drug|Betahistine|Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..
16291072|NCT00709202|Drug|Placebo Oral Tablet|
16291073|NCT00709189|Drug|Norgestimate/Ehinyl Estradiol; Folic acid.|
16291074|NCT00709176|Behavioral|Brief FOCUS Program|Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.
16291075|NCT00709176|Behavioral|Extensive FOCUS Program|Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.
16291076|NCT00709163|Drug|Nesiritide|The patient will be given an initial bolus of 1mcg/kg and then placed on a continuous infusion of 0.01mcg/kg/min. Three hours after the start of the infusion the patient will be rebolused with 1mcg/kg and increase the continuous infusion to 0.015mcg/kg/min. This will occur again at 6 hours after the start with an increase in the continuous infusion rate to 0.02mcg/kg/min. Patients will continue on the study drug for a total of 24 hours.
16291077|NCT00709163|Drug|5% Dextrose|The patient will be given an initial bolus of 1mcg/kg and then placed on a continuous infusion of 0.01mcg/kg/min. Three hours after the start of the infusion the patient will be rebolused with 1mcg/kg and increase the continuous infusion to 0.015mcg/kg/min. This will occur again at 6 hours after the start with an increase in the continuous infusion rate to 0.02mcg/kg/min. Patients will continue on the study drug for a total of 24 hours.
16291078|NCT00709150|Behavioral|Collaborative depression care management|Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are socio-culturally adaptated for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.
16291079|NCT00709150|Behavioral|Enhanced usual care|Participants will receive educational pamphlets on depression and a list of mental health resources in the community. Participants' primary care doctors will be free to prescribe antidepressant medication or provide other usual care.
16291080|NCT00709137|Drug|spironolactone|tablet form. doses used range from 12.5-50mg po QDAY. Total duration would be until completion or study or medication intolerance.
16291081|NCT00709137|Drug|amiloride|amiloride 2.5-10 mg po QDAY. Duration until completion of study or until tolerance
16291082|NCT00709124|Device|Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)|60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
16291083|NCT00709124|Device|Sham|60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied.
16291084|NCT00709111|Drug|Maraviroc|The maraviroc doses were 150 mg orally twice daily, 300 mg orally twice daily, or 600 mg orally twice daily, depending on the pharmacokinetic interaction with a subject's pre-study ART and non-ART drug regimen according to the package insert.
16291085|NCT00709098|Drug|iloprost|Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
16291086|NCT00709098|Drug|iloprost|Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
16291087|NCT00709072|Behavioral|SMS (Short Message Service) reminders|SMS reminders sent every 2 weeks
16291088|NCT00709059|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks
16291089|NCT00709059|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered based on body weight 800-1200 mg/day (<65 kg: 800 mg; 65 - 85 kg: 1000 mg; >85 kg: 1200 mg) orally for 48 weeks
16291090|NCT00709046|Drug|High dose pantoprazole infusion|Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
16291091|NCT00709046|Drug|Standard dose pantoprazole infusion|Pantoprazole 40mg iv bolus qd x 3 days
16291092|NCT00709033|Biological|autologous or syngeneic PBTLs and EBV-CTLs|"Three dose levels are being evaluated namely:
~GROUP 1
~PBTL CD19CAR-28 zeta 2x10exp7 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp7 cells/m2
~GROUP 2
~PBTL CD19CAR-28 zeta 1x10exp8cells/m2 and EBV-CTL CD19CAR zeta 1x10exp8 cells/m2
~GROUP 3
~PBTL CD19CAR-28 zeta 2x10exp8 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp8 cells/m2"
16291093|NCT00709020|Drug|white button mushroom extract|Dose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day.
16291094|NCT00709020|Other|flow cytometry|Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
16291095|NCT00709020|Other|high performance liquid chromatography|Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
16291096|NCT00709020|Other|laboratory biomarker analysis|Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.
16291097|NCT00709020|Other|mass spectrometry|Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
16291098|NCT00709020|Other|pharmacogenomic studies|Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.
16291099|NCT00709020|Other|pharmacological study|Performed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
16291100|NCT00709007|Behavioral|Directly Administered Antiretroviral Therapy (DAART)|Participants are observed taking HIV medications by study staff on days when they receive opioid agonist therapy (sub-lingual buprenorphine) at the clinic.
16291101|NCT00709007|Behavioral|SAT|Participants take their HIV medications by themselves.
16292075|NCT00702091|Drug|Ramipril|10 mg capsule
16291102|NCT00708994|Drug|THC|"Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
~Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or joint. Administered intravenously over 10 minutes.
~Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or joint. Administered intravenously over 10 minutes."
16291103|NCT00708994|Drug|Placebo|• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
16291104|NCT00708981|Other|Multifactorial Intervention|"Study group will receive multifactorial intervention for advanced diabetic nephropathy:
~Elements of multifactorial intervention:
~BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
~Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
~Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
~Patient enhanced self-management provided by combined diabetes-renal education curriculum.
~Behavior and social intervention
~Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators."
16291105|NCT00708968|Behavioral|FOCUS Program|Supportive, educative sessions with patients and spouses.
16291106|NCT00708942|Drug|Hexaminolevulinate (HAL)|Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
16291107|NCT00708942|Drug|Placebo|Placebo suppository, for 3-7 hours application
16291108|NCT00708942|Drug|Hexaminolevulinate (HAL)|Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
16291109|NCT00708942|Drug|Placebo|Placebo ointment for 5 hours application
16291110|NCT00708929|Procedure|Squatting|Squatting for 6 minutes
16291111|NCT00708916|Drug|CC-10004|20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
16291112|NCT00708903|Drug|neratinib|HKI-272
16291113|NCT00708903|Other|Placebo|Placebo
16291114|NCT00708903|Drug|Moxifloxacin|
16291115|NCT00708890|Behavioral|Brief motivation to participate in TSG|The intensive intervention will consist of a boost motivational session on follow-up alternatives and particularly on attending TSGs. Efforts will be made to connect the patients with TSG volunteers via the AA/NA contact telephone. The patients are encouraged to invite AA/NA contact persons to visit them on the ward. The patient will then have the possibility to be followed to a meeting after treatment. The patients in the intensive referral group will get a phone call four weeks after discharge. The focus of this call will be on continued motivation to attend TSGs.
16291116|NCT00708877|Procedure|Liver Transplantation|Transplantation will initially be performed with deceased donor livers using the technique of caval-sparing hepatectomy unless suspected caudate involvement or caudate atrophy is a concern regarding the resection margin. Patients will be assigned a provisional Model for End-Stage Liver Disease (MELD) score by the United Network for Organ Sharing (UNOS) Regional Review Board that will make a recipient eligible for transplantation within three months at the time of listing (typically 20-24). A segment of donor iliac artery will be used as an interposition graft to the recipient infrarenal aorta. The hilus will be avoided during dissection and the bile duct, hepatic artery, and portal vein will be divided as low as possible. A frozen section of the bile duct margin will be performed and patient will undergo pancreaticoduodenectomy if positive.
16291117|NCT00708851|Other|LCD Solution with NB-UVB Phototherapy|"LCD Solution: 2 applications / day
~NB-UVB Phototherapy: 3 light sessions / week"
16291118|NCT00708851|Device|NB-UVB Light Device (311-315 nm)|NB-UVB Phototherapy: 3 light exposures / week
16291119|NCT00708812|Drug|Endostar(Recombinant Human Endostatin Injection)|Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
16291120|NCT00708812|Drug|paclitaxel-carboplatin|paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
16291121|NCT00708799|Other|Azithromycin on admission - not enrolled in the RCT|One dose of azithromycin prior to inclusion to the RCT
16291122|NCT00708786|Device|ICD|Ventricular arrhythmia treatment
16291123|NCT00708786|Device|CRT-D|Ventricular arrhythmia treatment
16291124|NCT00708773|Drug|Irinotecan|"90 minute IV infusion once every 3 weeks.
~Dose will be based on sex and genotype determination."
16291125|NCT00708760|Behavioral|paper based training|read selected material, test skills learned in simulator lab
16291126|NCT00708760|Behavioral|web based training|read and view selected web based material, test skills learned in simulator lab
16291127|NCT00708747|Drug|Albumin (5% serum-protein solution containing immunoglobulins)|5% albumin was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.
16291128|NCT00708747|Drug|Biseko|Standardised 5% serum-protein solution (Biseko, Biotest, Dreieich, Germany) was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.
16291129|NCT00708734|Behavioral|functional exercise training|twice weekly group sessions for 5 weeks
16291130|NCT00708721|Drug|Clofarabine|Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies.
16291131|NCT00708708|Drug|etanercept (Enbrel®)|The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16291132|NCT00708695|Behavioral|Nurse Home Visiting|Visits from nurses from mid-pregnancy to child age 2 years.
16291133|NCT00708682|Biological|13-valent pneumococcal conjugate vaccine|
16291134|NCT00708669|Device|TAXUS stent|Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
16291135|NCT00708669|Device|Cypher stent|CYPHER stent, approved for commercialization in Japan(March 25, 2004)
16291136|NCT00708656|Drug|mesalazine (Asacol®)|800 mg tablets
16291137|NCT00708643|Device|Habitual Silicone Hydrogel Contact Lens|contact lens
16291138|NCT00708643|Device|narafilcon A|contact lens
16291139|NCT00708630|Behavioral|Extended information on side effects|More detailed information on possible side effects of vaccine
16291141|NCT00708604|Biological|Islet cell transplantation|Islet cell transplantation will occur through the portal vein.
16291142|NCT00708591|Drug|Rapamycin|Oral Rapamycin once weekly at assigned dose in 4 week cycles. Dosing can continue until disease progression or severe side effects are seen.
16291143|NCT00708591|Drug|Ketoconazole|Twice daily (200mg each time) at the start of the second week of therapy for 4 consecutive days. Dosing continues every week after the second week of therapy.
16291144|NCT00708578|Drug|Glimepiride|Once a day before breakfast
16291145|NCT00708578|Drug|Metformin|After breakfast and supper
16291146|NCT00708578|Drug|Insulin Glargine|Injection in the morning
16291147|NCT00708565|Drug|iloprost|Baseline echo measurements, cardiac output, pulse oximetry will be taken. Subjects will then be given one dose of inhaled iloprost. Post-inhalation, the measurements will be repeated at rest and with exercise.
16291148|NCT00708552|Drug|SB-742457|investigational drug
16291149|NCT00708552|Drug|Donepezil|comparator
16291150|NCT00708552|Drug|Placebo|comparator
16291151|NCT00708539|Drug|progesterone|90 mg, vaginal, once daily
16291152|NCT00708539|Drug|Progesterone|200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden
16291153|NCT00708526|Other|standard of care for phase one anesthesia care|Patients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery.
16291154|NCT00708526|Device|Quick Emergence Device|The Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg.
16291155|NCT00708500|Drug|Boceprevir (SCH 503034)|Boceprevir, 200 mg capsules, 800 mg TID PO
16291156|NCT00708500|Biological|Pegylated interferon alfa-2b (SCH 54031)|PEG2b 1.5 μg/kg/week subcutaneously (SC)
16291157|NCT00708500|Drug|Ribavirin (SCH 18908)|Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID).
16291158|NCT00708500|Drug|Boceprevir placebo|Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO.
16291159|NCT00708487|Other|Embryo incubator oxygen concentration|Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.
16291160|NCT00708474|Device|OsseoFit™ Porous Tissue Matrix™|Bone void filler
16291161|NCT00708461|Behavioral|weight gain prevention|"Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items.
~Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home.
~Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations.
~Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices."
16291162|NCT00708448|Radiation|PET Imaging|Patients will receive an FLT-PET scan, FDG-PET scan, a H215O-PET scan, and have a blood sample (15 cc, approximately 3 teaspoons) drawn for the genetic and protein studies. These studies will be done before patients begin taking erlotinib and bevacizumab.
16291163|NCT00708448|Drug|Erlotinib|150 mg/day
16291164|NCT00708448|Drug|Bevacizumab|15mg/kg q 21 days
16291165|NCT00708435|Biological|Beriplex® P/N (Kcentra)|Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
16291166|NCT00708435|Biological|Fresh frozen plasma|Intravenous Infusion, dosage depending on baseline INR and body weight
16291167|NCT00708422|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
16291168|NCT00708422|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
16291169|NCT00708409|Procedure|Cardiac valve surgery|Different autograft implantation techniques.
16291170|NCT00708396|Drug|Escitalopram|First week; 10mg/d of Escitalopram Weeks 2-5; 20mg/d of Escitalopram After 4 weeks of 20mg treatment (2-5 weeks of the study) - if partial/no response according to YBOCS score and clinical judgment, the dose will be increased up to 30mg for 4 weeks (weeks 6-9) and in case of partial/ non response the dose will be increased up to 40 mg until the completion of the study (weeks 10-13).
16291171|NCT00708383|Other|10% SSS embryo culture medium protein supplementation|10% SSS in addition to the 0.5% HSA already in the culture medium.
16291172|NCT00708383|Other|0.5% HSA embryo culture medium protein supplementation|0.5% HSA in the culture medium
16291173|NCT00708370|Other|COACH|COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.
16291174|NCT00708370|Other|No intervention for placebo|There will be no COACH health tele-counselling to patients randomized to Standard Care arm.
16291175|NCT00708357|Drug|NG-monomethyl-L-arginine|intravenous administration, bolus over 5 minutes, dosage 6mg/kg
16291176|NCT00708344|Drug|Irbesartan - Hydrochlorothiazide|150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks
16291177|NCT00708344|Drug|Irbesartan - Hydrochlorothiazide|150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks
16291821|NCT00703664|Drug|Vorinostat|Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.
16291178|NCT00708331|Device|2 HEMA Hydrophilic Acrylic Intraocular Lens|2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.
16291179|NCT00708318|Drug|i.v. fentanyl and AeroLEF|"Period I: subjects received an intravenous dose of fentanyl (200 µg) (Treatment A).
~Period II: subjects were randomly assigned to receive either 2 mL (Treatment B) or 3mL (Treatment C) of AeroLEF delivered by nebulization with an AeroEclipse BAN."
16291180|NCT00708305|Drug|Sodium Fluoride (NaF)|Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF
16291181|NCT00708305|Drug|Placebo|Fluoride free toothpaste (0ppmF)
16291182|NCT00708292|Drug|AUY922|
16291183|NCT00708292|Drug|Bortezomib|
16291184|NCT00708292|Drug|Dexamethasone|
16291185|NCT00708279|Procedure|Osteopathic manipulation|Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months.
16291186|NCT00708266|Device|Openflow microperfusion catheter|Macro-perforated, double lumen catheter used to withdraw interstitial fluid samples from different tissues.
16291187|NCT00708266|Dietary Supplement|Intralipid 20%|"Lipid emulsion used in clinical practice as supplementary intravenous nutrition. 28 hours venous infusion during the treatment study visits."
16291188|NCT00708266|Other|0.9% Saline Solution|"0.9% sodium chloride solution, used in clinical practice for venous hydration. 28 hours infusion during the control study visits."
16291189|NCT00708253|Device|Double-balloon procedure (DBE)|Double-balloon procedure (DBE): DBE is performed using the DBE T-type endoscope system (Fujinon Inc, Japan), as described in the literature. The DBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 8.5 mm and a flexible overtube with a length of 145 cm and an outer diameter of 12 mm. Latex balloons are attached to both the endoscope and the overtube. These balloons are inflated and deflated during insertion, as described elsewhere in detail (2,3).
16291190|NCT00708253|Device|Single-balloon procedure (SBE)|Single-balloon procedure (SBE): SBE is performed using the SBE endoscope system (SIF-Q180, Olympus Optical Co., Ltd., Tokyo, Japan). The SBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 9.2 mm and a flexible overtube with a length of 140 cm and an outer diameter of 13.2 mm. One single balloon is attached to the the tip of the overtube. The insertion process follows the method used for DBE, but instead of inflation of the endoscope balloon, the tip of the endoscope is angulated at straightening
16291191|NCT00708240|Drug|Escitalopram|Escitalopram will be provided in unit doses commercially available, with a starting dose, minimum effective dose, and maximum effective dose of 5 mg, 10 mg and 20 mg, respectively, given once daily.
16291192|NCT00708214|Drug|BIBW 2992|BIBW 2992 at high and medium dosages
16291193|NCT00708214|Drug|BIBW 2992|BIBW 2992 at high and medium dosages
16291194|NCT00708214|Drug|Letrozole|Letrozole at standard dosage
16291195|NCT00708214|Drug|Letrozole|Letrozole at standard dosage
16291196|NCT00708201|Drug|Alvimopan|
16291197|NCT00708201|Drug|Placebo|
16291198|NCT00708188|Device|Multidetector raw CT|Multidetector raw CT
16291199|NCT00708175|Drug|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
16291200|NCT00708175|Drug|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
16291201|NCT00708162|Drug|Elvitegravir|Elvitegravir (EVG) tablet administered orally once daily with food
16291202|NCT00708162|Drug|Raltegravir|Raltegravir tablet administered orally twice daily according to prescribing information
16291203|NCT00708162|Drug|EVG placebo|Placebo to match elvitegravir administered orally once daily
16291204|NCT00708162|Drug|RAL placebo|RAL placebo administered orally twice daily.
16291205|NCT00708162|Drug|Background regimen|Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.
16291206|NCT00708149|Drug|lansoprazole OD|arm 1: lansprazole 30 mg qd from NG route or orally for 14 days
16291207|NCT00708149|Drug|placebo|takepron placebo
16291208|NCT00708136|Behavioral|water based training program to improve balance|
16291209|NCT00708123|Drug|Sodium fluoride toothpaste|Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F
16291210|NCT00708123|Drug|Placebo toothpaste|Fluoride free toothpaste (0 ppm F)
16291211|NCT00708110|Drug|GSK1349572|GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors.
16291212|NCT00708110|Drug|Placebo|Placebo is a tablet with no drug in it.
16291213|NCT00708097|Drug|NaF|Fluoride
16291214|NCT00708097|Drug|Placebo|Placebo
16291215|NCT00708097|Drug|NaMFP|Fluoride
16291216|NCT00708084|Biological|CL184|CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
16291217|NCT00708084|Biological|HRIG|HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
16291218|NCT00708071|Biological|Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)|Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)
16291219|NCT00708045|Procedure|Imaging assessments|FDG-PET scans, functional MRI (fMRI) scans, Neuropsychological Testing
16291220|NCT00708032|Device|spectacles|habitual spectacles
16291221|NCT00708032|Device|narafilcon A soft contact lenses|narafilcon A daily disposable contact lenses
16291822|NCT00703651|Biological|Inactivated, split-virion influenza vaccine|0.1 mL, ID. 1 injection/year for 3 years
16291222|NCT00708019|Behavioral|PRO-SELF PLUS Pain Management Program|The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
16291223|NCT00708006|Drug|HGS1029|Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity
16291224|NCT00707993|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
16291225|NCT00707993|Drug|Glipizide|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
16291226|NCT00707980|Drug|Vortioxetine|Encapsulated vortioxetine immediate-release tablets
16291227|NCT00707967|Biological|GSK's candidate Mycobacterium tuberculosis vaccine 692342|Intramuscular injection, 2 doses at 0, 1 month
16291228|NCT00707967|Biological|Control vaccine with the adjuvant system.|Intramuscular injection, 2 doses at 0, 1 month
16291229|NCT00707967|Biological|Control vaccine with physiological saline|Intramuscular injection, 2 doses at 0, 1 month
16291230|NCT00707954|Drug|TA-7284|Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
16291231|NCT00707954|Drug|Placebo of TA-7284|Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
16291232|NCT00707941|Drug|Oseltamivir|"Children ≤12 years: Suspension by Weight (Kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml)
~Patients≥12 years: 75 mg capsules as follows:
~1 cap (75 mg) PO BID X 5 days
~≥ 40 75 mg PO BID 6.25"
16291233|NCT00707941|Drug|Placebo|"Children < 12 years, suspension by weight (kg) as follows: Dose X 5 days Volume (ml) < 15kg = 30 mg PO BID (2.5 ml) 15kg - 22kg = 45 mg PO BID (3.75 ml) 23kg - 39kg = 60 mg PO BID (5 ml)
~Patients≥12 years: 75 mg capsules as follows 1 cap (75 mg) PO BID X 5 days
~≥ 40 75 mg PO BID 6.25"
16291234|NCT00707928|Drug|nitroglycerine|nitroglycerine 100 microgram intravenous.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
16291235|NCT00707928|Other|NSS|NSS.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
16291236|NCT00707915|Drug|Drug: Benzodiazepine (listed out below)|"The benzodiazepine (BZD) dose will be discontinued in 4 weeks by a weekly 25% reduction. BZD-derivative hypnotics will include brotizolam, flunitrazepam, etizolam, quazepam, estazolam, nitrazepam, flurazepam, and diazepam.
~All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study. In addition, the use of trazodone (25-100 mg/day) will be allowed anytime throughout the study period. Subjects will be observed for 8 weeks."
16291237|NCT00707902|Drug|chlorhexidine/lidocaine|
16291238|NCT00707902|Drug|echinacea/sage|
16291239|NCT00707889|Drug|ABT-869|12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
16291240|NCT00707889|Drug|bevacizumab|10 mg/kg QD, IV on Day 1 of each 14-day cycle
16291241|NCT00707889|Drug|oxaliplatin|85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
16291242|NCT00707889|Drug|folinic acid|400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
16291243|NCT00707889|Drug|fluorouracil|400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
16291244|NCT00707889|Drug|ABT-869|7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle
16291245|NCT00707876|Drug|ferumoxytol|Dose 1 versus non-contrast MRA
16291246|NCT00707876|Drug|ferumoxytol|Dose 2 versus non-contrast MRA
16291247|NCT00707876|Drug|ferumoxytol|Dose 3 versus non-contrast MRA
16291248|NCT00707863|Drug|Escitalopram|10 mg of Escitalopram by mouth once a day for 8 weeks
16291249|NCT00707850|Drug|PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)|PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
16291250|NCT00707837|Other|Preterm infant formulas and discharge formulas|Preterm infant formulas to be consumed per health care provider orders
16291251|NCT00707837|Other|Preterm infant formula with added soluble lipids|Preterm infant formula to be fed per healthcare provider instructions
16291252|NCT00707824|Drug|nalbuphine|nalbuphine 5 mg epidural
16291253|NCT00707824|Drug|nalbuphine|nalbuphine 10 mg epidural
16291254|NCT00707824|Other|NSS|NSS
16291255|NCT00707798|Biological|Pneumococcal vaccine GSK2189242A|Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
16291256|NCT00707798|Biological|Pneumo 23™|One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
16291257|NCT00707785|Dietary Supplement|Vitamin A|50,000 IU of Vitamin A 50,000 IU of vegetable oil
16291258|NCT00707772|Drug|PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)|PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
16291259|NCT00707772|Drug|PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)|PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
16291260|NCT00707759|Drug|Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone|"Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
~3°day: Prednisone 2 mg/kg/d in 2 doses
~4ºday: Prednisone 1 mg/kg/d in 2 doses
~5ºday: Prednisone 0.5 mg/kg/d in 2 doses
~6ºday: Prednisone 0.25 mg/kg/d in 2 doses
~7ºday: Stop Prednisone"
16291690|NCT00704626|Other|Cheek swab|A swab will be swished around the inside of the mouth to collect mouth (buccal) cells. This will be done with each blood draw.
16291261|NCT00707759|Drug|Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone|"Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
~10°days after Tx: 2 mg/kg/d
~Day 11 - 20: 1 mg/kg/d
~Day 21 - 30: 0.5 mg/kg/d
~Day 31 - 60: 0.3 mg/k/d
~Week 8 - 12: 0.25 mg/k/d
~Week 12 - 16: 0.20 mg/k/d
~Week 16 - 20: 0.15 mg/k/d
~Month 6 - 12: 0.10 - 0.12 mg/k/d"
16291262|NCT00707746|Drug|mipomersen|
16291263|NCT00707746|Drug|placebo|
16291264|NCT00707720|Device|TERIS procedure|The implantation of the restrictive implant
16291265|NCT00707707|Drug|AZD2281|Dose finding study to establish the appropriate dose of AZD2281
16291266|NCT00707707|Drug|Paclitaxel|Intravenous infusion over 1 hour
16291267|NCT00707681|Drug|MS-20|4 ml/vial
16291268|NCT00707681|Drug|Placebo|4ml/vial
16291269|NCT00707655|Drug|Zalutumumab|Eight weekly infusions
16291270|NCT00707642|Biological|WN-80E|Three injections of the study vaccine [Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)] given one month apart
16291271|NCT00707642|Biological|WN-80E|Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
16291272|NCT00707642|Biological|WN-80E|Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
16291273|NCT00707642|Biological|WN-80E|Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
16291274|NCT00707616|Other|Oral glucose tolerance test|one time 75g oral glucose tolerance test for measurement of insulin secretion and action
16291275|NCT00707590|Drug|BMS-767778 or Placebo|
16291276|NCT00707577|Behavioral|Internet-based maintenance program|The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program.
16291277|NCT00707564|Device|HemCon Dental Dressing|The HemCon Dental Dressing is an oral wound dressing made of chitosan
16291278|NCT00707564|Device|Gauze with pressure|Gauze with pressure
16291279|NCT00707551|Drug|Ketoconazole|Tablet, administered as repeated doses.
16291280|NCT00707551|Drug|Verapamil|Extended Release tablet, administered as repeated doses.
16291281|NCT00707551|Drug|AZD1305|Extended Release tablet, administered as a single dose.
16291282|NCT00707538|Drug|BMS747158|2 IV injection of ~11 mCi (total) F-18 labeled compound
16291283|NCT00707525|Procedure|Preimplantation Genetic Diagnosis|Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
16291284|NCT00707512|Drug|natalizumab|Administered as specified in the TOUCH Prescribing Program
16291285|NCT00707499|Drug|BMS747158|Single dose administration.
16291286|NCT00707486|Device|Hemcon Dental Dressing|The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
16291287|NCT00707486|Device|Gauze with Pressure and/or Gelfoam|Common practice for oral surgery patients involves the use of sterile dressing over the extraction site. The subject will provide the pressure by biting down on the sterile gauze. As previously discussed, other practices involve the use of Gelfoam prior to application of sterile gauze.
16291288|NCT00707473|Drug|Carboplatin|Given IV
16291289|NCT00707473|Other|Chemoradiotherapy|Undergo chemoradiotherapy
16291290|NCT00707473|Drug|Cisplatin|Given IV
16291291|NCT00707473|Procedure|Definitive Surgical Resection|Undergo surgery
16291292|NCT00707473|Drug|Docetaxel|Given IV
16291293|NCT00707473|Drug|Fluorouracil|Given IV
16291294|NCT00707473|Procedure|Quality-of-Life Assessment|Correlative studies
16291295|NCT00707473|Radiation|Radiation Therapy|Undergo radiation therapy
16291296|NCT00707460|Behavioral|Dietary Intervention (Macronutrient composition)|"The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item.
~All groups are exposed to nutrition education on serving size and portion size."
16291297|NCT00707447|Behavioral|PREDIAS|Group programme aiming at modification of lifestyle: lifestyle changes, 12 lesson a 90 minutes, delivered in a group setting, consists of analysis of barriers against lifestyle changes, behavior analysis of eating and exercise behavior, modification of unhealthy lifestyle and relapse prevention
16291298|NCT00707447|Behavioral|Control|Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
16291299|NCT00707434|Device|Guardian® blood-sugar monitoring device|The device has a small catheter that will be inserted subcutaneous tissue of the subject's abdomen or thigh set to continuously monitor glucose throughout the ICU stay for up to 15 days.
16291300|NCT00707421|Drug|ketorolac acetate|
16291301|NCT00707421|Drug|fluorometholone|
16291302|NCT00707421|Drug|artificial lacrimal tears|
16291303|NCT00707408|Drug|Imatinib|Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Novartis provided supplies of imatinib for all patients included in the study.
16291304|NCT00707382|Genetic|(1) Genotyping for CYP4502D6 and 2C19 polymorphisms|"In this study arm (1), the genotype information is given to the physician in charge of treatment and can be used to direct the pharmacological treatment according to local guidelines. In the guidelines the genotype is translated to the clinical designation normal, slow or fast metabolizer of CYP2D6 or normal or slow metabolizer of CYP2C19. Different treatment options for the different genotypes are described."
16291328|NCT00707161|Radiation|Radiation Therapy|Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).
16291329|NCT00707161|Drug|Cisplatin|Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
16291642|NCT00704951|Drug|Posaconazole or alternative fungal treatment|"Dosage of Posaconazole:
~Prophylactic dosing: 200mg tid (600mg/day) Treatment dosing: 400mg bid (800mg/day)"
16291305|NCT00707382|Other|(2) Intense clinical monitoring|In this study arm (2) the genotype information is not revealed. The intervention consists of an intensified clinical monitoring of treatment effect, side effects and patient perspective. Staffpersonnel is trained in the use of a clinical manual that builds on a selection of validated questions from the Scale for the Assessment of Positive Symptoms (SAPS), Side effect score (Udvalg af Kliniske Undersøgelser (UKU) and Rating of Medical Influences (ROMI). The manual has to be used at least once in a quarter (every third month), which is monitored by the study personnel. Data registered by the patients primary contact person are not used as outcome measures in the study but only as intervention tool for the optimisation of the medical antipsychotic treatment.
16291306|NCT00707382|Other|(3) Control|In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
16291307|NCT00707369|Drug|Amoxicillin and Metronidazole|tablets: Amoxicillin 3H2O 574 mg and 400 mg metronidazole three times daily for 7 days
16291308|NCT00707369|Drug|Placebo|Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days
16291309|NCT00707356|Drug|WST11|WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4 mg/Kg or 6 mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered through transperineal interstitial optical fibers. If deemed necessary and in consideration of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and alternate energy (300 J/cm) might be applied.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. The number of fibers and the total light energy will be adapted to each patient, taking into account the tumor localization and the volume of the prostate.
16291310|NCT00707343|Radiation|FLT-PET Imaging|radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.
16291311|NCT00707330|Drug|Clarithromycin|Prolonged release tablet, 500 mg, 1 tablet a day for a week
16291312|NCT00707304|Drug|Talactoferrin|Oral, 1.5 grams twice per day
16291313|NCT00707304|Drug|Placebo|Oral, twice per day
16291314|NCT00707278|Radiation|Radiation Therapy|Radiation therapy will be delivered concurrently with capecitabine and oxaliplatin chemotherapy Radiation therapy dose will be 50.4 Gy (1.8 Gy per day, 5 days per week, for 28 treatments).
16291315|NCT00707278|Drug|Capecitabine|Capecitabine Dose (given twice daily concurrent with radiation therapy) Dose level 1: 400 mg/m2 Dose level 2:600 mg/m2 Dose level 3:600 mg/m2
16291316|NCT00707278|Drug|Oxaliplatin|Oxaliplatin Dose (given weekly concurrent with radiation therapy) Dose level 1: 50 mg/m2 Dose level 2: 50 mg/m2 Dose level 3: 60 mg/m2
16291317|NCT00707265|Device|rhBMP-2/CRM/CD HORIZON® Spinal System|"The rhBMP-2/CRM component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and a compression resistant matrix (CRM) carrier consisting of an absorbable collagen sponge imbedded with biphasic calcium phosphate.
~The posterior spinal fixation system, the CD HORIZON® Spinal System, is a commercially available rod-based spinal system intended for temporary stabilization of the spine in order to facilitate fusion. The CD HORIZON® Spinal System is available in either titanium or stainless steel. For this study, only titanium implant components will be used."
16291318|NCT00707265|Device|Autograft/CD HORIZON® Spinal System|The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System. When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for several indications including degenerative disc disease.
16291319|NCT00707252|Drug|Polyphenon E|Patients will be assigned to 3 sequential cohorts of three different dose levels of Polyphenon E (providing 200, 400 and 800mg of Polyphenon E given once daily) in a step-wise manner.
16291320|NCT00707252|Drug|Tarceva|All patients will also receive Erlotinib 150mg po/day from Day 1.
16291321|NCT00707239|Drug|tigecycline|An initial intravenous (IV) loading dose of 150 mg of tigecycline, followed by 75 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus [MRSA]).
16291322|NCT00707239|Drug|tigecycline|An initial intravenous (IV) loading dose of 200 mg of tigecycline, followed by 100 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus [MRSA]).
16291323|NCT00707239|Drug|imipenem/cilastatin|Imipenem/cilastatin 1g intravenous (IV) will be administered approximately every 8 hours, for up to 14 consecutive days. In addition vancomycin 15 mg/kg IV approximately every 12 hours (q12h), an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and ceftazidime placebo will be given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus [MRSA]).
16291324|NCT00707213|Procedure|Imaging study (FDG-PET/CT scan)|FDG-PET/CT scan-The scans that will be done with a radioactive sugar ([18F]fluoro-2-deoxy-D-glucose) and positron emission tomography (FDG-PET/CT). These scans will help to identify areas of possible infection.
16291325|NCT00707187|Drug|Cialis|35 pills of study medication (20 mg)
16291326|NCT00707174|Drug|Imiquimod Cream|Our current standard-of-care is to use imiquimod daily for 12 weeks followed by a staged-excision with 2mm margins per stage. These margins are justified because the standard-of care for lentigo maligna is continuing to evolve
16291327|NCT00707174|Drug|Tazarotene Cream 0.1%|Tazarotene is a topical retinoid cream that is commonly used to treat psoriasis and acne. It is known to help keratinocyte maturation and thinning of the stratum corneum (top layer of the epidermis). The stratum corneum functions as the primary barrier to the penetration of topical medications. The penetration of topical medications can be enhanced if the stratum corneum is thinned. We believe that the treatment of lentigo maligna with imiquimod, and staged-excision, will be improved by the addition of tazarotene cream.
16291330|NCT00707161|Procedure|Surgical resection|Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).
16291331|NCT00707148|Drug|Placebo|Saline (0.9% NaCl) administered as a single 0.5 mL intramuscular injection into the deltoid.
16291332|NCT00707148|Biological|Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed|Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap). Administered as a single 0.5 mL intramuscular injection into the deltoid.
16291333|NCT00707135|Drug|Rapamycin|Rapamycin given once weekly in escalating doses. Higher dose levels will be split with the half the dose given on day 1 and half the dose on day 2 (24 hours later).
16291334|NCT00707122|Other|Albumin and Crystalloids|"From day 2 to day 28 (or until ICU discharge, whichever comes first), fluid will be administered as follows:
~1. treated group: albumin will be infused on a daily basis, aimed to maintain its serum concentration equal or above 30 g/l (8). In particular, after the daily determination of its serum level:
~if lower than 25 g/l, 300 ml of 20% of albumin solution (total amount of 60 gr) will be infused;
~if equal or higher than 25 g/l and below 30 g/l, 200 ml of 20% of albumin solution (total amount of 40 gr) will be infused;
~if higher than or equal to 30 g/l, no albumin will be infused. Albumin solutions will be infused over a period of 3 hours. Further infusion of crystalloids will be allowed, when necessary, according to the clinical judgment. No infusion of colloids, other than albumin, will be admitted."
16291335|NCT00707122|Other|Crystalloids|"Volume replacement will be performed in both the treated and the control group according to the early-goal directed therapy.
~control group: crystalloids infusion will be allowed whenever necessary on a clinical basis. Albumin administration will be restricted to emergency use, as clinically judged and documented according to the standard criteria of each participating unit. No other colloids will be allowed."
16291336|NCT00707083|Drug|dexamethasone|Given oral
16291337|NCT00707083|Drug|mercaptopurine|Given orally
16291338|NCT00707083|Drug|methotrexate|Given orally
16291339|NCT00707083|Drug|vincristine sulfate|Given IV
16291340|NCT00707070|Drug|efalizumab plus placebo|1 mg/kg/week subcutaneous for 24 weeks
16291341|NCT00707070|Drug|efalizumab plus acitretin|1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
16291342|NCT00707057|Drug|Ibuprofen 600 mg Extended-Release Tablets|Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.
16291343|NCT00707057|Drug|Placebo|Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.
16291344|NCT00707044|Procedure|Control group (usual care)|control group, care as usual, 24 hours intensive care stay
16291345|NCT00707044|Procedure|Short-Stay Intensive Care treatment (SSIC)|Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
16291346|NCT00707031|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16291347|NCT00707031|Device|Pen auto-injector|
16291348|NCT00707031|Drug|Exenatide|Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner.
16291349|NCT00707031|Device|Prefilled pen injector|
16291350|NCT00707031|Drug|Metformin|Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.
16291351|NCT00707018|Device|External rotation shoulder sling|The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.
16291352|NCT00707018|Device|Internal rotation shoulder sling|The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.
16291353|NCT00706992|Biological|ALVAC-MART-1 vaccine|Given subcutaneously
16291354|NCT00706992|Biological|MART-1:26-35(27L) peptide vaccine|Given subcutaneously
16291355|NCT00706992|Biological|Aldesleukin|Given subcutaneously
16291356|NCT00706992|Biological|autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes|Given intravenously (IV)
16291357|NCT00706992|Biological|incomplete Freund's adjuvant|Given subcutaneously
16291358|NCT00706979|Other|Practice Quit Attempt plus nicotine lozenge|nicotine lozenge, 2 mg or 4 mg
16291359|NCT00706979|Behavioral|Practice Quit Attempt only|Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
16291360|NCT00706966|Drug|dutasteride|6 months of dutasteride 3.5 mg daily
16291361|NCT00706953|Drug|bortezomib; pegylated liposomal doxorubicin|1.3 mg/m2 IV bolus on Days 1,4,8,11 of each 21-day cycle; 30 mg/m2 IV infusion on Day 4 of each 21 day cycle
16291362|NCT00706927|Drug|latanoprost 0.005% + timolol 0,5% fixed combination|1 drop per day and eye for 6 weeks
16291363|NCT00706927|Drug|brimonidine 0,2% + timolol 0,5% fixed combination|1 drop twice a day per eye for 6 weeks
16291364|NCT00706914|Drug|Once-daily aclidinium/formoterol|Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
16291365|NCT00706914|Drug|Twice-daily formoterol fumarate|Inhaled formoterol fumarate 12 µg twice-daily (BID)
16291366|NCT00706914|Drug|Placebo to formoterol fumarate|Inhaled placebo to formoterol fumarate once-daily in the evening
16291367|NCT00706914|Drug|Once-daily formoterol fumarate|Inhaled formoterol fumarate 12 μg once-daily in the evening
16291481|NCT00706069|Drug|Capecitabine|Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days
16291482|NCT00706030|Drug|neratinib|
16291483|NCT00706030|Drug|vinorelbine|
16292185|NCT00701142|Biological|Saline solution|Single intravenous infusion
16291368|NCT00706901|Behavioral|Arm 1 GMI|Participants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller & Rollnick 2013) and based on a manualized protocol (Martino & Santa Ana 2013; Santa Ana & Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions.
16291369|NCT00706901|Behavioral|Arm 2 IHMD|Participants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation.
16291370|NCT00706901|Behavioral|Arm 3 TCC|TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics
16291371|NCT00706888|Dietary Supplement|Vitamins B6, B9 and B12 and polyphenols|
16291372|NCT00706888|Dietary Supplement|placebo|
16291373|NCT00706875|Behavioral|questionnaire|"A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
~In person at the medical appointment
~Over the telephone
~Mailed with self-addressed return envelope and prepaid postage
~E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage"
16291374|NCT00706875|Behavioral|questionnaire|"A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
~In person at the medical appointment
~Over the telephone
~Mailed with self-addressed return envelope and prepaid postage
~E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage"
16291375|NCT00706862|Drug|Talactoferrin|Oral, 1.5 grams twice per day
16291376|NCT00706862|Drug|Placebo|Oral, twice per day
16291377|NCT00706849|Drug|mipomersen sodium|200 mg /mL
16291378|NCT00706849|Drug|placebo|1 mL matching placebo
16291379|NCT00706836|Drug|Pregabalin 50mg|One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
16291380|NCT00706836|Drug|Pregabalin 200 MG|One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
16291381|NCT00706836|Drug|placebo|One dose of matched oral placebo to be administered one hour prior to fMRI scan
16291382|NCT00706823|Device|i-gel airway (Intersurgical Ltd., Wokingham, England)|supra-glottic airway device
16291383|NCT00706823|Device|Laryngeal Mask Airway-Unique|supra-glottic airway device
16291384|NCT00706810|Drug|Hydroxyurea|Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.
16291385|NCT00706810|Drug|Verapamil|Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.
16291386|NCT00706797|Drug|etanercept (EnbrelTM)|
16291387|NCT00706797|Drug|methotrexate|
16291388|NCT00706784|Drug|Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System|Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System
16291389|NCT00706771|Drug|Sodium bicarbonate|Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
16291390|NCT00706771|Drug|Sodium chloride|0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
16291391|NCT00706758|Behavioral|IBS school|Structured patient group education
16291392|NCT00706758|Behavioral|IBS-guidebook|Written information - IBS-guidebook
16291393|NCT00706745|Dietary Supplement|oil rich in cis9, trans11 conjugated linoleic acid|An oil rich in cis9, trans11 conjugated linoleic acid (cis9,trans11-CLA). Of the total amount of CLA in the oil, 80% is cis9, trans11-CLA and 20% trans10, cis12-CLA. In total 4 grams of oil will be given daily. The oil will be taken in the form of soft gel capsules. Two capsules will be taken in the morning and two in the evening.
16291394|NCT00706745|Dietary Supplement|placebo|identical placebo capsules.
16291395|NCT00706732|Biological|AVX502|2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
16291396|NCT00706732|Biological|AVX502|2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
16291397|NCT00706732|Biological|Placebo|2 doses of placebo given at T=0 and T=4 weeks via the IM route
16291398|NCT00706732|Biological|Placebo|2 doses of placebo given at T=0 and T=4 weeks via the SC route
16291399|NCT00706719|Drug|25 mg Androxal|25 mg Androxal capsules, 1 capsule daily for 6 months
16291400|NCT00706719|Drug|Testim 1%|Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
16291401|NCT00706706|Drug|Sunitinib Malate (SU011248)|Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
16291402|NCT00706693|Dietary Supplement|Ingestion of BD glucose tablets (TM)|Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with BD glucose tablets by giving 10g of glucose in children 10 and under. Children and teens over 10 will receive 15g of glucose.
16291403|NCT00706693|Dietary Supplement|Ingestion of Skittles (TM)|Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with Skittle by giving 10g of sucrose in children 10 and under. Children and teens over 10 will receive 15g of sucrose.
16291404|NCT00706693|Dietary Supplement|Ingestion of Fruit to Go (TM)|Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with Fruit to Go by giving 10g of fructose in children 10 and under. Children and teens over 10 will receive 15g of fructose.
16291484|NCT00706017|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16291485|NCT00706004|Drug|lubiprostone|lubiprostone 24 microgram capsule taken twice daily for 4 weeks
16291486|NCT00705991|Procedure|ROTEM|
16291487|NCT00705978|Drug|Pancreatin|Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
16291488|NCT00705978|Drug|Placebo|placebo
16291405|NCT00706680|Drug|Thymoglobulin|methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days. Patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.
16291406|NCT00706667|Drug|Ferinject ®|iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO
16291407|NCT00706654|Drug|Aripiprazole depot 300 or 400 mg|Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.
16291408|NCT00706654|Drug|Aripiprazole 10-30 mg orally|Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.
16291409|NCT00706654|Drug|Aripiprazole depot 25 or 50 mg|Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.
16291410|NCT00706654|Drug|Placebo depot|Placebo depot was supplied in lyophilized vials.
16291411|NCT00706654|Drug|Placebo tablets|Placebo tablets were identical in appearance to the aripiprazole tablets.
16291412|NCT00706641|Drug|Dasatinib|Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
16291413|NCT00706641|Procedure|Radical Cystectomy|Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
16291414|NCT00706628|Drug|BIBF 1120|
16291415|NCT00706628|Drug|BIBW 2992|
16291416|NCT00706628|Drug|Sequential BIBF 1120 + BIBW 2992|
16291417|NCT00706615|Biological|Ad-sig-hMUC-1/ecdCD40L vaccine|
16291418|NCT00706589|Drug|aripiprazole|Initial dose : 2mg, Maximum dose : 20mg
16291419|NCT00706589|Drug|placebo|Initial dose: 2mg, Maximum dose:20mg
16291420|NCT00706576|Drug|Infusion of opioid growth factor|Volunteers will be treated with an intravenous infusion of opioid growth factor(OGF) starting at 100 µg/kg with a 50 µg/kg dose escalation with each succeeding group. The investigational drug, OGF, will be diluted in sterile saline to its appropriate concentration based upon the body weight of the volunteer and administered in a volume of 60 ml over 45 minutes (rate of 2 ml/min)
16291421|NCT00706563|Biological|Fluarix™|Single intramuscular dose on Day 0
16291422|NCT00706550|Biological|(PV) 23-valent pneumococcal polysaccharide vaccine|Currently commercially available pneumococcal polysaccharide vaccine
16291423|NCT00706550|Biological|Placebo|Placebo
16291424|NCT00706537|Drug|Active treatment|20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
16291425|NCT00706537|Drug|Placebo|Placebo as two tablets once daily for three weeks
16291426|NCT00706511|Device|CPAP|CPAP (continuous positive airway pressure) treatment at home for 6 weeks
16291427|NCT00706498|Drug|BI 2536|
16291428|NCT00706485|Device|Yttrium-90 Plaque Applicator|Placed on the dura during surgery for 10-17 1/2 minutes
16291429|NCT00706459|Device|Magnetic Resonance Imaging|All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.
16291430|NCT00706446|Drug|tiotropium bromide|tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
16291431|NCT00706446|Drug|Salmeterol|salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
16291432|NCT00706446|Drug|Formoterol|formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
16291433|NCT00706446|Drug|Fluticasone propionate|Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.
16291434|NCT00706446|Drug|budesonide|Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the patient was on before the start of the trial.
16291435|NCT00706433|Drug|aminolevulinic acid HCL (ALA)|Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
16291436|NCT00706433|Other|Vehicle (VEH)|Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.
16291437|NCT00706420|Procedure|Islet Transplantation + Immunosuppression|Islet Transplantation + Immunosuppression (Sirolimus/Tacrolimus, daclizumab)
16291438|NCT00706420|Biological|Islet cell transplantation|Islet cell transplantation will occur through the portal vein.
16291489|NCT00705965|Behavioral|Psychotherapy|Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
16291490|NCT00705965|Behavioral|Information session|One information session about living with heart disease.
16291491|NCT00705965|Other|Usual cardiological care|Usual cardiological care
16291492|NCT00705952|Other|Lifestyle intervention|Diet, exercise and behavioural change intervention.
16291493|NCT00705939|Drug|Taliglucerase alfa|Intravenous infusion every 2 weeks
16291439|NCT00706407|Device|Fully integrated Uro-NIRS:UDS|As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamix device will take measurements through the skin without inserting anything into the body.
16291441|NCT00706381|Drug|Sincalide|
16291442|NCT00706381|Drug|Ursodiol|
16291443|NCT00706381|Procedure|Fat Meal|600 calorie meal containing 72% fat, 8% protein, and 20% carbohydrate
16291444|NCT00706381|Procedure|Carb meal|600 calorie meal containing 100% carbohydrate
16291445|NCT00706381|Drug|Placebo|IV and/or oral placebo
16291446|NCT00706368|Device|Point of care tests|Several point-of-care tests are offered: OSOM TV rapid trichomonas test; OSOM BV Blue rapid test; pHEMalert vaginal pH test. All subjects receive the OSOM TV test, while the other two are optional.
16291447|NCT00706355|Drug|PF-04217903|Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days
16291448|NCT00706342|Drug|Fostamatinib Disodium / R935788|R935788 tablets
16291449|NCT00706329|Device|Deflux|Patients undergo surgery using Deflux to correct umbilical hernia
16291450|NCT00706316|Biological|EBV-Specific CTLs and CD45 Mab|"One time infusion (IV) at one of the following dose levels:
~Dose level I: 5 x 107 cells/m2
~Dose level II: 1 x 108 cells/m2
~Dose level III: 2 x 108 cells/m2"
16291451|NCT00706303|Behavioral|Supported self management training and support|Supported Self-management. This will consist of fortnightly individual patient sessions at home of approximately 40 minutes for two months, with home visits at a maximum frequency of 6 weeks thereafter for 1 year. Further details of the rubric of the initial training sessions are given in Appendix 1 and will use adapted versions of the Bourbeau self-management and education materials. Follow up visits will be less structured, and based on the patient's individual agenda as well as reviewing and reinforcing basic self-management messages. Patients will be provided with an individualised self-management plan and symptom diary cards to use as a monitoring aid. Patients will be trained to identify and treat exacerbations associated with purulent sputum with antibiotic and those associated with increased breathlessness, mucoid sputum and/or upper airway symptoms with Prednisolone.
16291452|NCT00706290|Behavioral|Brief Cognitive Behavioral Therapy|The cognitive-behavioral intervention consists of 6-7 sessions lasting 60-90 minutes each focused on psycho-education; relaxation training; cognitive-restructuring and coping with cancer fears; and activity planning and pacing. Sessions are delivered by a licensed clinical psychologist or trained psychology fellow or graduate student.
16291453|NCT00706277|Drug|propofol|propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour
16291454|NCT00706277|Drug|propofol|propofol 2mg
16291455|NCT00706277|Drug|remifentanil|remifentanil 0,25mcg/kg/hour
16291456|NCT00706277|Drug|fentanyl|fentanyl 100mcg
16291457|NCT00706277|Drug|Sevoflurane/Nitrous Oxide|maintenance of anesthesia with sevoflurane and nitrous oxide
16291458|NCT00706264|Device|Silicon ring (Arabin Pessary)|Placement of a silicon pessary in the vagina, around the cervix.
16291459|NCT00706251|Device|Silicone tube|Silicone tube which is inserted into the tear duct through the punctum in the eyelid, then passed through the tear duct till it enters the nose and secured in place using a surgical knot. The tube remains in place for 3-6 months, than take out by the surgeon.
16291460|NCT00706238|Biological|GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A|IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
16291461|NCT00706225|Drug|Bazedoxifene and conjugated estrogens|Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
16291462|NCT00706199|Procedure|Bone marrow aspiration|Collection of a 2 ml bone marrow sample from an aspirate carried out for medical purposes.
16291463|NCT00706186|Drug|Sodium Oxybate|The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6 g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be increased to a dosage of 9 g/day, if tolerated by the patient.
16291464|NCT00706173|Drug|Hydrocortisone|Hydrocortisone 10-20 mg PO daily for 4 weeks.
16291465|NCT00706173|Drug|Placebo|"Placebo 10-20 mg PO daily for 4 weeks."
16291466|NCT00706147|Drug|Arimoclomol|Drug: Arimoclomol capsules given three times per day
16291467|NCT00706147|Drug|Placebo|Drug: Placebo capsules given three times per day
16291468|NCT00706134|Drug|Placebo|Placebo tablet taken once daily in the morning with a light meal.
16291469|NCT00706134|Drug|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
16291470|NCT00706134|Drug|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
16291471|NCT00706134|Drug|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
16291472|NCT00706121|Drug|Vitamin E|400 IU daily by mouth for 7 - 12 years
16291473|NCT00706121|Drug|Selenium|200 mcg daily for 7 - 12 years
16291474|NCT00706121|Drug|Vitamin E placebo|1 pill by mouth daily for 7 - 12 years
16291475|NCT00706121|Drug|selenium placebo|1 pill by mouth daily for 7 - 12 years
16291476|NCT00706108|Behavioral|Observational study|Observational (descriptive) study of technical and non-technical performance
16291477|NCT00706095|Drug|E7389|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
16291478|NCT00706095|Drug|E7389|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
16291479|NCT00706095|Drug|E7389|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
16291480|NCT00706069|Drug|Vinorelbine oral|Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday
16291494|NCT00705926|Drug|Highly Active Antiretroviral Therapy (HAART)|Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.
16291495|NCT00705926|Other|No treatment|Participants in this group will not receive treatment at this stage of their infection.
16291496|NCT00705913|Device|Mitroflow Aortic Pericardial Heart Valve (CarboMedics)|Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
16291497|NCT00705913|Device|Carpentier-Edwards Magna Tissue Valve|Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
16291498|NCT00705900|Drug|LCD|2 applications / day for 12 weeks
16291499|NCT00705900|Drug|calcipotriol|2 applications / day for 12 weeks
16291500|NCT00705887|Behavioral|Brief Motivational Enhancement Intervention|The motivational enhancement intervention lasted 5-8 minutes and consisted of gaining the client's permission to address the topic of skin cancer prevention, exchanging information through the elicit-provide-elicit strategy of information exchange, and summarization/ conclusion based on verbal and nonverbal cues from the participant.
16291501|NCT00705874|Drug|CGC-11047 and gemcitabine|Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg).
16291502|NCT00705874|Drug|CGC-11047 and docetaxel|Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 minutes every 21 days. CGC-11047 will be administered only on Day 1 of each 21-day cycle and will start at dose level -1 (50 mg).
16291503|NCT00705874|Drug|CGC-11047 and bevacizumab|Bevacizumab: 5 mg/kg administered IV once every 14 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
16291504|NCT00705874|Drug|CGC-11047 and erlotinib|Erlotinib: 150 mg taken orally every day of each 28-day cycle. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
16291505|NCT00705874|Drug|CGC-11047 and cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
16291506|NCT00705874|Drug|CGC-11047 and 5-flurouracil / leucovorin|5-Flurouracil / Leucovorin: Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 wks, repeated every 56 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
16291507|NCT00705874|Drug|CGC-11047 and sunitinib|Sunitinib: 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle). CGC-11047 will be administered on Days 1 and 8 of a 21 day cycle.
16291508|NCT00705861|Drug|Placebo|Placebo as a substitute of SK3530 100mg
16291509|NCT00705861|Drug|SK3530|SK3530 100mg
16291510|NCT00705835|Biological|rsPSMA protein plus Alhydrogel® vaccine|The assigned dose of rsPSMA protein plus Alhydrogel® vaccine will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4-week break and then a fourth vaccination during week 7. The vaccination site will rotate to a different quadrant with each administration.
16291511|NCT00705822|Drug|Docetaxel + Estramustine + Hydrocortisone|"Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg.
~Combination of these 3 drugs every 3 weeks"
16291512|NCT00705822|Drug|Docetaxel + Prednisone|Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.
16291513|NCT00705796|Drug|MPP10, testosterone|Testosterone intranasal, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM).
16291514|NCT00705796|Drug|Testosterone|AndroGel® 50 mg, once daily in the morning after washing/showering.
16291515|NCT00705783|Drug|Aripiprazole depot|Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.
16291516|NCT00705783|Drug|Placebo depot|Placebo depot was supplied in 400 mg lyophilized vials.
16291517|NCT00705770|Drug|Anecortave Acetate|"Low dose
~Sustained release depot suspension"
16291518|NCT00705770|Drug|Anecortave Acetate|"Middle dose
~Sustained release depot suspension"
16291519|NCT00705770|Drug|Anecortave Acetate|"High dose
~Sustained release depot suspension"
16291520|NCT00705770|Drug|Placebo|Placebo treatment with vehicle
16291521|NCT00705757|Drug|latanoprost|Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
16291522|NCT00705757|Drug|bimatoprost|Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
16291523|NCT00705757|Drug|travoprost|Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
16291524|NCT00705744|Drug|Lactic acid (Dermacyd Femina)|
16291525|NCT00705718|Device|Endurant Stent Graft System|Abdominal Aortic Aneurysm Repair
16291526|NCT00705705|Behavioral|Network leader training|Network leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk. The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network. Leaders will be asked to share these messages with other members of their groups.
16291527|NCT00705705|Behavioral|Standard HIV risk-reduction counseling|Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.
16291528|NCT00705692|Drug|Levamisole|
16291529|NCT00705692|Drug|Placebo|
16291536|NCT00705666|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
16291537|NCT00705666|Drug|Ribavirin (SCH 18908)|Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
16291538|NCT00705653|Drug|PG-11047|PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).
16291539|NCT00705640|Biological|incomplete Freund's adjuvant|Given subcutaneously and intradermally
16291540|NCT00705640|Biological|multi-epitope melanoma peptide vaccine|Given subcutaneously and intradermally
16291541|NCT00705640|Biological|tetanus toxoid helper peptide|Given subcutaneously and intradermally
16291542|NCT00705640|Procedure|biopsy|Patients undergo surgical biopsy at replicate vaccine site
16291543|NCT00705627|Drug|neoadjuvant chemotherapy plus concurrent chemoradiotherapy|Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
16291544|NCT00705614|Biological|Remicade|The treating physician will determine the treatment regimen and dose of Remicade.
16291545|NCT00705601|Procedure|PSG|PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.
16291546|NCT00705588|Drug|Tadalafil|Orally, titrated to maximum 20mg od
16291547|NCT00705588|Drug|Vardenafil|Orally, titrated to 10 mg bid
16291548|NCT00705575|Drug|Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
16291549|NCT00705575|Drug|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
16291550|NCT00705562|Other|milk protein formulas, varying carbohydrate/protein sources|ad lib for 0-8 days of age until 28 days of age
16291551|NCT00705549|Drug|Gemcitabine|Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
16291552|NCT00705549|Drug|Cisplatin|Cisplatin I.V at the dose of 75mg/m2 on Day 1
16291553|NCT00705549|Drug|Docetaxel|Docetaxel I.V at the dose of 75mg/m2 on Day 1
16291554|NCT00705549|Drug|Cisplatin|Cisplatin I.V at the dose of 80mg/m2 on Day 1
16291555|NCT00705549|Drug|Vinorelbine|Vinorelbine per os 50mg every Monday, Wednesday and Friday
16291556|NCT00705549|Drug|Pemetrexate|Pemetrexate I.V 500mg/m2 on Day 1
16291557|NCT00705536|Drug|Humalog|
16291558|NCT00705536|Drug|Humulin-R|
16291559|NCT00705536|Drug|Recombinant human hyaluronidase PH20 (rHuPH20)|
16291560|NCT00705523|Drug|varenicline|1.0 mg BID for 12 weeks
16291561|NCT00705523|Drug|placebo|BID 12 weeks
16291562|NCT00705510|Drug|0.05% cyclosporin eye drop|use the medication twice daily for 3 months
16291563|NCT00705497|Procedure|Radiofrequency Tumor Ablation|Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
16291564|NCT00705484|Biological|infliximab|The treating physician will determine the treatment regimen and dose of Remicade.
16291565|NCT00705484|Drug|Standard Therapy|The standard therapy group will consist of participants receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy participant will be left to the discretion of the treating physician and may change during the course of a participant's participation in the registry.
16291566|NCT00705471|Biological|Infliximab|None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.
16291567|NCT00705458|Procedure|Coronary Computed Tomography Angiography|64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)
16291568|NCT00705458|Procedure|Stress Nuclear Myocardial Perfusion Imaging|Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.
16291569|NCT00705445|Dietary Supplement|Micronutrient Supplementation without Zinc|This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid
16291570|NCT00705445|Dietary Supplement|Micronutrient Supplementation with Zinc|This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.
16291571|NCT00705445|Other|Nutritional Counselling and Education|This will contain Nutritional Counselling and Education.
16291572|NCT00705432|Biological|Peginterferon alfa-2b (PEG)|Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
16291573|NCT00705432|Drug|Ribavirin (RBV)|Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).
16291574|NCT00705432|Drug|Placebo|Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID).
16291575|NCT00705432|Drug|Boceprevir|Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.
16291576|NCT00705419|Drug|Vicriviroc maleate|Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
16291577|NCT00705419|Drug|Vicriviroc maleate|Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
16291578|NCT00705419|Drug|Placebo|Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
16291579|NCT00705419|Drug|Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg|Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol.
16291580|NCT00705406|Drug|Peramivir|600 mg peramivir administered as bilateral 2-mL intramuscular injection
16291581|NCT00705406|Drug|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
16291640|NCT00704964|Biological|PegIntron|PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany
16291870|NCT00703313|Drug|0.3% gatifloxacin ophthalmic solution|1 drop instilled at each visit
16291582|NCT00705380|Behavioral|Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents|CBT with PCT treatment will consist of 11 weekly sessions that are designed to be developmentally appropriate for a younger population. The primary aim of this treatment will be to directly influence three aspects of panic attacks and general anxiety: the cognitive/misinterpretational aspect, the hyperventilatory response, and the conditioned reactions to physical sensations. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks.
16291583|NCT00705380|Behavioral|Waitlist control|During the 12-week waitlist period, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. Participants will also meet with a therapist every other week to discuss the nature of any panic attacks or address any concerns.
16291584|NCT00705367|Drug|Placebo|Infusion, Intravenous, single dose, Day 1
16291585|NCT00705367|Drug|Abatacept|Infusion, Intravenous, 30mg/kg, single dose, Day 1
16291586|NCT00705367|Drug|Abatacept|Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study
16291587|NCT00705354|Drug|Bacitracin|Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics
16291588|NCT00705354|Procedure|Nasopore sponge soaked with saline|Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
16291589|NCT00705341|Drug|fluticasone|Inhaled corticosteroid approved for treatment of asthma
16291590|NCT00705328|Behavioral|Primary Health Care Model (PRMHLTH)|Primary health care service delivery
16291591|NCT00705328|Behavioral|Recreation Coordination Model (REC)|Recreation coordination service delivery
16291592|NCT00705328|Behavioral|Comprehensive Model (COMP)|a comprehensive service delivery model consisting of PRMHLTH plus REC.
16291593|NCT00705315|Drug|Docetaxel|Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
16291594|NCT00705315|Drug|Epirubicin|Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
16291595|NCT00705315|Drug|Bevacizumab|Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles
16291596|NCT00705302|Behavioral|Group training with self-help group|Combined educational and exercise program for pulmonary rehabilitation, with (1) or without(2 a self-help group. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group. Patients will instead of five of the group training sessions, participate in a self-help group.
16291597|NCT00705302|Behavioral|Group training|Combined educational and exercise program for pulmonary rehabilitation. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group.
16291598|NCT00705289|Biological|Infliximab|Infliximab used in line with current clinical practice and local guidelines.
16291599|NCT00705276|Drug|Lactic acid (Dermacyd Femina Delicata)|
16291600|NCT00705263|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16291601|NCT00705263|Drug|Ribavirin (SCH 18908)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16291602|NCT00705250|Drug|bendamustine hcl|Patients will receive bendamustine 120mg/m^2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul.
16291603|NCT00705237|Procedure|Functional Endoscopic Sinus Surgery with Balloon Dilatation|Luma lightwire technology will be utilized in conjunction with fluoroscopy for patients with sinusitis undergoing functional endoscopic sinus surgery with balloon dilatation. Trans-illumination of the sinus will be compared to fluoroscopy for accuracy
16291604|NCT00705224|Biological|Pegylated Interferon|"Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
~The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous
~injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.
~The Sponsor did not provide formal drug supply."
16291605|NCT00705224|Drug|Ribavirin|"Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
~The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
~The Sponsor did not provide formal drug supply."
16291606|NCT00705211|Drug|Ezetimibe|Ezetimibe, 10-mg tablets,
16291607|NCT00705211|Drug|Ezetimibe + other lipid-lowering medication(s)|Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician
16291608|NCT00705198|Drug|Temozolomide (for newly diagnosed malignant glioma)|"Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.
~Temozolomide is administered as 20 mg and 100 mg capsules."
16291641|NCT00704964|Drug|Rebetol|Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany
16291643|NCT00704938|Biological|aldesleukin|Intravenous (IV) aldesleukin 720,000 IU/kg every 8 hours for a maximum of 15 doses.
16291609|NCT00705198|Drug|Temozolomide (for relapsed malignant glioma)|"Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle.
~Temozolomide is administered as 20 mg and 100 mg capsules."
16291610|NCT00705198|Radiation|Radiotherapy (for patients with newly diagnosed malignant glioma)|Although the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma.
16291611|NCT00705172|Drug|somatropin|Prader-Willi syndrome children treated with at least one dose of Norditropin®
16291612|NCT00705159|Drug|loteprednol etabonate and tobramycin|Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
16291613|NCT00705159|Drug|loteprednol etabonate|Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
16291614|NCT00705159|Drug|Tobramycin|Topical ocular administration of Tobramycin QID for 14 days.
16291615|NCT00705159|Drug|Vehicle of Zylet|Topical ocular administration of the vehicle of Zylet QID for 14 days.
16291616|NCT00705146|Device|Comfort Cool thumb splint by North Coast Medical|Comfort Cool(TM) splint, a prefabricated neoprene splint, fit according to the participant's size (S, M, M+, L). Participants instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Used for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.
16291617|NCT00705146|Device|Custom made thermoplastic & neoprene splint|The Hybrid splint was based on Pat McKee's custom-made splint design, fabricated from neoprene and 1.6 mm Rolyan Aquaplast Watercolors (Bollingbrook, IL). Participants were instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Splint was worn for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.
16291618|NCT00705133|Drug|Treprostinil|For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated
16291619|NCT00705120|Other|Bone Marrow Cell Transplantation|
16291620|NCT00705120|Radiation|Irradiation, Total Body|
16291621|NCT00705120|Drug|Cyclophosphamide|
16291622|NCT00705120|Drug|Cyclosporin|
16291623|NCT00705120|Procedure|Mesenchymal Stem Cell Transplantation|
16291624|NCT00705120|Drug|Busulfan|
16291625|NCT00705107|Biological|PegIntron pen (peginterferon alfa-2b; SCH 54031)|PegIntron administered in accordance with approved labeling.
16291626|NCT00705107|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered in accordance with approved labeling
16291627|NCT00705081|Drug|ezetimibe|10 mg once daily
16291628|NCT00705081|Drug|statin|
16291629|NCT00705042|Drug|Etanercept|
16291630|NCT00705016|Drug|Cilengitide 2000 mg once weekly|Cilengitide 500 milligram (mg) will be administered as an intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by 2000 mg dose of cilengitide on Day 8 and 15 of every cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason.
16291631|NCT00705016|Drug|Cilengitide 2000 mg twice weekly|Cilengitide 2000 mg will be administered as an intravenous infusion over 60 minutes, twice weekly on Day 1, 4, 8, 11, 15, and 18 of each 3-week cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants will receive cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason.
16291632|NCT00705016|Drug|Cetuximab|Cetuximab will be administered as 250 milligram per square meter (mg/m^2) as infusion (initial starting dose of 400 mg/m^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason.
16291633|NCT00705016|Drug|5-fluorouracil (5-FU)|5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.
16291634|NCT00705016|Drug|Cisplatin|Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.
16291635|NCT00705003|Drug|BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD|BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks
16291636|NCT00705003|Drug|BCI-024 (Buspirone)|Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks.
16291637|NCT00705003|Drug|Matching placebo|Placebo comparator once a day at bedtime for 6 weeks.
16291638|NCT00704990|Dietary Supplement|Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)|Weight based dosing of a chewable natural health product containing 15-35 mg zinc citrate, 150-350 mg magnesium lactate, 30-70 mg pyridoxine hydrochloride and 150-350 mg calcium ascorbate. Participants will take weight based dose two times during the day with meals for a 10 week period
16291639|NCT00704977|Procedure|pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique|"The eye operated is disinfected and covered according routine protocol.
~Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS.
~Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS.
~Wound closure by by technique described in each arm.
~Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment.
~Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks.
~Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs."
16291871|NCT00703300|Drug|bortezomib|Given IV
16291644|NCT00704938|Biological|anti-p53 T-cell receptor-transduced peripheral blood lymphocytes|Intravenous (IV) anti-p53 TCR transduced PBL will be administered at a a dose of 1 x 10^8 cells to 5 x 10^10 cells.
16291645|NCT00704938|Biological|autologous dendritic cell-adenovirus p53 vaccine|Ad-p53 DC vaccine, up to 2 x 10^8 ad-p53 DCs per dose will be administered subcutaneously, divided into 4 injections, one into each of the 4 extremities. Ad-p53 DCs will be administered subcutaneously on day 7 (± 2 days), day 14 (between day 14 and day 18), and day 28 (between day 25 and day 42) post T cell infusion.
16291646|NCT00704938|Biological|filgrastim|subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day).
16291647|NCT00704938|Drug|cyclophosphamide|60mg/kg/day (Days-7,-6)
16291648|NCT00704938|Drug|fludarabine phosphate|25mg/m^2 (Days -5, -4, -3, -2, and -1)
16291649|NCT00704925|Drug|3, 4 DAP|Patients with clinically-confirmed LEMS will receive 3, 4 DAP by mouth in slowly increasing doses. Treatment will begin with 5 mg three times a day and will increase by 50% every two weeks to 10-15 mg three to six times a day, as clinically needed, and if tolerated.
16291650|NCT00704912|Drug|Orlistat/Meal Replacement/Lifestyle Modification|Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
16291651|NCT00704912|Drug|Loestrin 1/20|Patients will be started on a low dose containing OCP for a continuous 4 month period.
16291652|NCT00704912|Drug|Combination of treatments|Medications will be administered as described for the other 2 arms.
16291653|NCT00704899|Procedure|Physiotherapy|Structured exercise regimen
16291654|NCT00704899|Drug|Amitryptiline|Amitryptiline 25mg once daily
16291655|NCT00704886|Other|video|video of dementia
16291656|NCT00704860|Other|Open label pharmacotherapy|"Dosage and drug types change based on patients need and response.
~doxepin, clomipramine, amoxapine, amitriptyline, maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline, isocarboxazid, phenelzine, tranylcypromine, moclobemide, fluvoxamine, paroxetine, fluoxetine, sertraline, citalopram, escitalopram, venlafaxine, atomoxetine, pramipexole, bromocriptine, quetiapine, clozapine, olanzapine, ziprasidone, aripiprazole, paliperidone, Risperidone, bupropion, mirtazapine, pindolol, topiramate, trazodone, Lithium,"
16291657|NCT00704847|Drug|Oral Salmon Calcitonin|0.8mg SMC021, twice daily
16291658|NCT00704847|Drug|Oral Salmon Calcitonin (Placebo)|0.8mg Placebo, twice daily
16291659|NCT00704834|Other|Blood Draw|35 cc of peripheral blood will be obtained by venipuncture from each subject.
16291660|NCT00704821|Drug|PTC299|Oral
16291661|NCT00704821|Drug|Docetaxel|Intravenous infusion
16291662|NCT00704808|Procedure|Primary surgical treatment|Primary surgery for tumor resection.
16291663|NCT00704808|Radiation|Radiotherapy|Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
16291664|NCT00704808|Drug|Temozolomide|Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
16291665|NCT00704795|Other|Oral glucose tolerance test|50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).
16291666|NCT00704795|Other|Isoglycemic iv glucose infusion|The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.
16291667|NCT00704782|Drug|dimebon|
16291668|NCT00704769|Drug|Desloratadine (assigned by investigator as part of normal practice)|Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits
16291669|NCT00704756|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
16291670|NCT00704756|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered based on body weight 800-1200 mg/day (<65 kg : 800 mg, 65 - 85 kg : 1000 mg, >85 kg : 1200 mg) orally for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
16291671|NCT00704743|Device|Cylindrical cast|Arm cast/immobilization technique for wrist fracture
16291672|NCT00704743|Device|Modified sugar tong cast|Arm cast/immobilization technique for wrist fracture
16291673|NCT00704743|Device|Volar dorsal splint|Arm cast/immobilization technique for wrist fracture
16291674|NCT00704730|Drug|XL184|Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
16291675|NCT00704730|Drug|Placebo|Gelatin capsules color and size-matched to XL184 capsules administered orally daily
16291676|NCT00704717|Biological|PegIntron (peginterferon alfa-2b; SCH 54031) pen|PegIntron pen administered in accordance with approved labeling
16291677|NCT00704717|Drug|Rebetol (ribavirin; SCH 18908)|Rebetol administered in accordance with approved labeling.
16291678|NCT00704704|Drug|5-aza-cytidine and Thalidomide|5-AZA-Cytidine 75mg/m2 5 days a month. 12 months. Thalidomide 50mg orally daily for 6 months.
16291679|NCT00704691|Drug|Lenalidomide|Lenalidomide 25 mg as a daily oral dose days 1-21 followed by a 7 day rest period (28 day cycle) for 1-6 cycles
16291680|NCT00704678|Drug|SBR759|1g tid
16291681|NCT00704678|Drug|Sevelamer HCl|1.6 g tid
16291682|NCT00704678|Drug|Sevelamer HCl|1.5 g tid
16291683|NCT00704678|Drug|Sevelamer HCl|0.8 g tid
16291684|NCT00704665|Drug|Relaxin|10 ug/kg/day or 25 ug/kg/day
16291685|NCT00704665|Drug|Relaxin|Placebo
16291686|NCT00704639|Drug|Cetuximab|Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy
16291687|NCT00704639|Drug|Carboplatin|Weekly intravenous carboplatin (AUC 2) for the duration of the RT
16291688|NCT00704639|Radiation|Radiotherapy|"The radiotherapy schedule will be the infield boost (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended)."
16291689|NCT00704626|Other|Blood Draw|A 5cc sample of serum will be drawn from each subject. Only one blood draw is required, but up to 8 additional blood draws can be obtained.
16291691|NCT00704600|Drug|nelfinavir|"Phase I:
~take nelfinavir tablets (minimum 6, maximum 10) starting 7 days before start of chemoradiotherapy, for 45 days
~day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample
~day 0: PET-CT
~Phase II:
~take nelfinavir tablets (MTD from phase 1) starting 7 days before start of chemoradiotherapy, for 45 days
~day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample
~day 7 biopsy
~day 7, 21 and week 15 :PET-CT + perfusion CT"
16291692|NCT00704574|Drug|insulin detemir|No extra intervention, only normal clinical practise for treatment of type 1 diabetes
16291693|NCT00704561|Device|ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)|ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
16291694|NCT00704561|Device|DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)|DRIVER bare metal stent implanted in acute myocardial infarction
16291695|NCT00704561|Device|Coronary stent implantation|Comparison of Drug Eluting versus Bare Metal Stent
16291696|NCT00704561|Device|Bare Metal Coronary Stent|Comaprison between Drug Eluting and Bare Metal Coronary Stents
16291697|NCT00704548|Drug|Simvastatin 40mg|Simvastatin once daily, orally in the morning period, during eigth weeks
16291698|NCT00704548|Drug|Placebo|Placebo once daily, orally in the morning period, during eigth weeks
16291699|NCT00704535|Drug|Ezetimibe|1 tablet of 10 mg once daily
16291700|NCT00704522|Biological|Peginterferon alfa-2b (SCH 54031)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16291701|NCT00704522|Drug|Ribavirin (SCH 18908)|Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
16291702|NCT00704522|Behavioral|Patient assistance program|"Assistance programs will be classified as follows:
~Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications)
~Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
~In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only."
16291703|NCT00704509|Drug|Bifeprunox|20 mg daily, encapsulated tablets, orally, 12 months
16291704|NCT00704509|Drug|Placebo|Encapsulated tablets, orally, 12 weeks
16291705|NCT00704509|Drug|Quetiapine|600 mg daily, encapsulated tablets, orally, 12 months
16291706|NCT00704496|Drug|Pseudoephedrine|Pseudoephedrine is a 240 mg PO per day
16291707|NCT00704483|Drug|SBR759|Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
16291708|NCT00704483|Drug|Sevelamer HCl|0.8 g tid
16291709|NCT00704483|Drug|SBR759|1.5 g tid
16291710|NCT00704483|Drug|Sevelamer HCl|1.6 g tid
16291711|NCT00704470|Other|Medical simulator training|Contains seminars on airway management, general anesthesia, peri-arrest arrhythmias, and advanced life support. Furthermore, participants train in simulator scenarios. In the debriefing instructors discuss management of the critical incidents using videotapes of the scenarios.
16291712|NCT00704470|Other|Simulator based crew resource management course|Contains seminars on human error and non-technical skills. Furthermore, participants train in simulator scenarios. In the debriefing instructors discuss usage of non-technical skills as well as behaviour of the participants using videotapes of the scenarios.
16291713|NCT00704444|Drug|Ezetimibe|Ezetimibe, 10-mg tablets
16291714|NCT00704444|Drug|Ezetimibe + other lipid-lowering medication(s)|Ezetimibe, 10-mg tablets + other lipid-lowering medication(s), as prescribed by attending physician
16291715|NCT00704431|Drug|SB-480848 (darapladib)|160 mg darapladib
16291716|NCT00704418|Drug|Bromfenac|sterile ophthalmic solution
16291717|NCT00704418|Drug|Placebo|sterile ophthalmic solution
16291718|NCT00704405|Drug|Vaniprevir|Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.
16291719|NCT00704405|Drug|Pegylated Interferon (Peg-IFN)|Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
16291720|NCT00704405|Drug|Ribavirin (RBV)|Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg.
16291721|NCT00704405|Drug|Placebo (PBO)|Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.
16291722|NCT00704392|Drug|XL647|Tablets supplied at 50-mg strength administered orally daily
16291723|NCT00704392|Drug|XL147|Gelatin capsules supplied at 25-mg and 100-mg strengths administered orally daily
16291724|NCT00704379|Drug|Placebo|an inactive substance
16291725|NCT00704379|Drug|Sertraline|Sertraline and placebo will be given in a double blind fashion via an equal number of identical tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention. Blood samples will be obtained randomly, one during the first and one during the second trimesters of the protocol.
16291726|NCT00704366|Drug|AZD0530|oral, tablet, once daily, dose will be variable
16291727|NCT00704353|Drug|Ferric Carboxymaltose|15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
16291728|NCT00704353|Drug|Standard Medical Care (SMC)|Per product label
16291729|NCT00704340|Device|DuraSeal Dural Sealant System|The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. DuraSeal should only be used with autologous duraplasty material.
16291730|NCT00704340|Other|Standard of Care|Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.
16291731|NCT00704314|Drug|Simvastatin|80 mg Simvastatin daily for 8 weeks
16291732|NCT00704314|Drug|Placebo|The placebo was identical in appearance and was provided by the same manufacturer
16291818|NCT00703677|Drug|Lithium|All participants will receive lithium. The dosage will be titrated over a 5-week period and then continued for an additional 6 months.
16291733|NCT00704301|Drug|Rivastigmine|Rivastigmine, two times 1,5 mg a day. The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
16291734|NCT00704301|Drug|Placebo|Placebo, 2 times a day
16291735|NCT00704288|Drug|XL184|Gelatin capsules supplied in 25-mg and 100-mg strengths; continuous daily dosing
16291736|NCT00704275|Drug|0.05% cyclosporin eye drop|bid dosage for 4 months
16291737|NCT00704262|Drug|Calcipotriol plus hydrocortisone (LEO 80190)|Once daily application
16291738|NCT00704249|Drug|nevirapine|Full-dose nevirapine from baseline (200 mg bid).
16291739|NCT00704249|Drug|nevirapine|Nevirapine with an increase in the initial dose (200 mg once daily for 14 days and 200 mg bid thereafter)
16291740|NCT00704236|Drug|Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment)|50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica
16291741|NCT00704236|Drug|Placebo|
16291742|NCT00704223|Drug|biphasic insulin aspart|Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation
16291743|NCT00704210|Device|SpineMed Table, Cert HealthSciences LLC|For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.
16291744|NCT00704210|Device|SpineMed Table, Cert HealthSciences LLC|Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.
16291745|NCT00704184|Drug|Comparator: Vaniprevir|Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
16291746|NCT00704184|Drug|Comparator: Pegylated-Interferon (Peg-IFN)|Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
16291747|NCT00704184|Drug|Comparator: Ribavirin|Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
16291748|NCT00704184|Drug|Comparator: placebo|Matching placebo to vaniprevir; duration of treatment: 28 days
16291749|NCT00704171|Procedure|Standard Tissue Closure Techniques|Standard Tissue Closure Techniques (sutures and staples only)
16291750|NCT00704171|Device|PleuraSeal Lung Sealant System|
16291751|NCT00704158|Drug|CR011-vcMMAE|administered as an intravenous infusion on Day 1 of a 21 day cycle.
16291752|NCT00704145|Device|Taxus Libertè™ paclitaxel drug-eluting stent|device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant
16291753|NCT00704132|Drug|Comparator: sitagliptin phosphate|Sitagliptin tablet 100 mg, administered once daily before the morning meal.
16291754|NCT00704132|Drug|Comparator: placebo (unspecified)|Matching placebo tablet, administered once daily before the morning meal.
16291755|NCT00704119|Drug|RhuDex®|"Treatment A.1: 31.65 mg RhuDex® once N=12
~Treatment A.2: 63.33 mg RhuDex® once N=12
~Treatment A.3: 126.63 mg RhuDex® once N=12
~Treatment A.4: 253.26 mg RhuDex® once N=12
~Treatment B.1: 31.65 mg RhuDex® once N=12
~Treatment B.2: selected dose of RhuDex® once N=12
~Treatment C: selected dose of RhuDex® once N=12
~Treatment D: selected dose of RhuDex® twice daily for 6 days N=12"
16291756|NCT00704106|Drug|Entecavir|0.5 or 1 mg dose qd
16291757|NCT00704093|Device|Right ventricular pacing|Right ventricular pacing vs. sinus rhythm or atrial pacing at the same rate
16291758|NCT00704080|Drug|XL765 (SAR245409)|Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; continuous daily dosing
16291759|NCT00704080|Drug|Temozolomide|Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days
16291760|NCT00704067|Behavioral|Supported employment plus cognitive training|Supported employment for 12 months plus cognitive training for the first 12 weeks
16291761|NCT00704067|Behavioral|Enhanced supported employment|Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.
16291762|NCT00704054|Drug|ridaforolimus|Ridaforolimus is given as an IV infusion over 30 minutes on days 1-5 and 15-19 of each 28 day cycle. For children less than 10 kg body weight, dosing will be adjusted.
16291763|NCT00704028|Drug|Ferric Carboxymaltose|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
16291764|NCT00704028|Drug|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
16291765|NCT00704015|Behavioral|Smoking cessation|Nurses, specifically trained for smoking cession program, contacted the patients at the orthopedic wards and initiated the intervention (stop smoking) within 1-2 days after acute hospitalization. The intervention included one or two personal meetings and weekly phone contacts during 6 weeks with a trained nurse. A phone number to a non-smoking hotline was provided for all patients. The patients were continuously encouraged not to smoke and free nicotine substitution (Nicorette®) was offered those who needed it. No other drug therapy was used.
16291766|NCT00704002|Procedure|antegrade intramedullary splinting|antegrade intramedullary splinting with 2 to 3 small K-wires
16291767|NCT00704002|Procedure|conservative treatment|conservative treatment with 2-finger splint for one week
16291768|NCT00703989|Dietary Supplement|benfotiamine, α-lipoic acid|benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for a total duration of four weeks
16291769|NCT00703976|Drug|Bevacizumab|Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.
16291770|NCT00703976|Drug|Cetuximab|Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.
16291771|NCT00703976|Drug|Pemetrexed|Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.
16291772|NCT00703976|Radiation|Radiation therapy|Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks
16291872|NCT00703300|Drug|decitabine|Given IV
16291773|NCT00703963|Device|INRatio monitor by Hemosense|Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip. The test strip is then inserted into the INRatio point-of-care self-testing coagulometer. After approximately 2 minutes of analysis, the INR value will be presented on the meter's display.
16291774|NCT00703963|Other|Usual Care|Usual care is defined as that care currently received by patients into whom mechanical heart valves are placed. Typically, these patients undergo frequent checks of their INR level until the therapeutic range is achieved. Then periodic INR levels are drawn at the discretion of the managing physician.
16291775|NCT00703950|Procedure|cup feeding|Method to feed: cup. This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup
16291776|NCT00703950|Procedure|bottle feeding|bottle feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using bottle
16291777|NCT00703937|Drug|Ferric Carboxymaltose (FCM)|
16291778|NCT00703937|Drug|Standard Medical Care (SMC) for the treatment of IDA|
16291779|NCT00703924|Drug|WR 279,396|A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion
16291780|NCT00703924|Drug|Placebo|Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
16291781|NCT00703911|Drug|eptacog alfa (activated)|Treatment of patients experiencing bleeds at the discretion of the physician/caregiver
16291782|NCT00703898|Drug|nevirapine|200 mg/day twice a day
16291783|NCT00703885|Drug|0.25 mg alprazolam|"0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan
~Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart."
16291784|NCT00703885|Drug|1.0 mg alprazolam|"1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
~Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart."
16291785|NCT00703885|Drug|placebo|"Placebo (liquid) to be administered 1 hour prior to fMRI scan
~Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart."
16291786|NCT00703872|Drug|Oral HDV-Interferon + ribavarin|Naive pateints
16291787|NCT00703872|Drug|Injectable HDV-Interferon + ribavarin|Nonresponders
16291788|NCT00703859|Drug|Dichloroacetate (DCA)|DCA starting at an initial dose of 3mg/kg twice daily PO for consecutive days (days 1-5) on a 28 days cycle up to 6 cycles unless evidence of tumour progression. Each dose to be administered with food at the same time everyday 12 hours apart.
16291789|NCT00703846|Drug|Ketoconazole|Foam, 2%, Extina will be applied twice daily (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleared. All symptom flares should be treated throughout the 12-month study period.
16291790|NCT00703833|Drug|MK0777|Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777
16291791|NCT00703833|Drug|Placebo (unspecified)|matching placebo
16291792|NCT00703820|Drug|Cytarabine|See Detailed Description
16291793|NCT00703820|Drug|Daunorubicin|See Detailed Description
16291794|NCT00703820|Drug|Etoposide|See Detailed Description
16291795|NCT00703820|Drug|Clofarabine|See Detailed Description
16291796|NCT00703820|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16291797|NCT00703807|Drug|Topotecan|Dose escalation, 5 dose levels, 1.5 mg/m2 - 2.3 mg/m2, PO day 1-5 every 21 days
16291798|NCT00703807|Drug|RAD001|Dose level -1, 5 mg qod Dose level 1, 5 mg qod Dose level 2, 5 mg qd Dose level 3, 5 mg qd DOse level 4, 10 mg qd
16291799|NCT00703794|Device|The AXIUM Progressive Coil System|Embolization of aneurysm
16291800|NCT00703781|Drug|bromfenac ophthalmic solution|sterile ophthalmic solution
16291801|NCT00703781|Drug|placebo|sterile ophthalmic solution
16291802|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
16291803|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
16291804|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
16291805|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
16291806|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
16291807|NCT00703755|Drug|Fenofibrate /Metformin|fenofibrate placebo + metformin 850 mg bid (F0-M1700)
16291808|NCT00703755|Drug|Placebo|Placebo
16291809|NCT00703742|Drug|Escitalopram|A,1: Escitalopram, oral, 20 mg/day, 8 weeks
16291810|NCT00703729|Device|Cold Compression (CC)|The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.
16291811|NCT00703729|Other|Ice Wrap (IW)|The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.
16291812|NCT00703703|Drug|Darifenacin|Darifenacin tablets 15 mg once daily
16291813|NCT00703703|Drug|Tolterodine|Tolterodine extended release (ER) 4 mg once daily
16291814|NCT00703703|Drug|Placebo|Placebo tablet once daily
16291815|NCT00703690|Drug|MK0767|MK0767 2.5, 5, and 10 mg/day supplied as tablets
16291816|NCT00703690|Drug|Comparator: fenofibrate|fenofibrate 200 mg supplied as capsules
16291817|NCT00703690|Drug|Comparator: Placebo (unspecified)|matching placebo will be supplied as tablets/capsules.
16291819|NCT00703664|Drug|Bortezomib|Bortezomib: 1.3 mg/m^2/d IV days 1, 4, 8, and 11.
16291823|NCT00703651|Biological|Inactivated, split-virion influenza vaccine|0.1 mL, ID. 1 injection/year for 3 years.
16291824|NCT00703651|Biological|Inactivated, split-virion influenza vaccine|0.5 mL, IM. 1 injection/year for 3 years
16291825|NCT00703638|Drug|cisplatin|Cisplatin administered intravenously, 75 mg/m^2 over 1-2 hours on day 1 of a 21 day cycle
16291826|NCT00703638|Drug|pemetrexed disodium|Pemetrexed 500 mg/m^2 intravenously (IV) will be given as a 10-minute intravenous infusion (after cisplatin) on day 1 of a 21 day cycle
16291827|NCT00703638|Drug|sorafenib|daily oral sorafenib (200 mg or 400 mg bid)
16291828|NCT00703625|Drug|Temsirolimus|
16291829|NCT00703625|Drug|Docetaxel|
16291830|NCT00703612|Procedure|Autologous Adipose-derived Stem cells|Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
16291831|NCT00703599|Procedure|Autologous Adipose-derived Stem cells|Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
16291832|NCT00703586|Drug|Maraviroc|"ARM A:
~Addition of maraviroc to baseline ARV medications for 24 weeks at one of the following doses:
~150 mg orally BID when coadministered with a ritonavir-boosted protease inhibitor
~600 mg orally BID when coadministered with efavirenz or nevirapine
~ARM B:
~Addition of an additional NRTI to baseline ARV medications for 12 weeks then cross over to maraviroc intensification for an additional 12 weeks as above:
~Addition of abacavir 600 mg orally once daily to a tenofovir containing regimen for 12 weeks then replacing the abacavir with maraviroc.
~Addition of an alternate FDA approved NRTI [such as zidovudine (AZT) or didanosine (ddi)] at standard oral dosing to a tenofir containing regimen for 12 weeks (if the participant declines abacavir therapy) then replacing the alternate NRTI with maraviroc.
~Addition of tenofovir 300 mg daily to an abacavir containing regimen for 12 weeks then replacing the tenofovir with maraviroc."
16291833|NCT00703573|Drug|S-777469 400 mg|S-777469 400 mg BID
16291834|NCT00703573|Drug|S-777469 800 mg|S-777469 800 mg BID
16291835|NCT00703573|Drug|Placebo|Placebo BID
16291836|NCT00703547|Drug|GSK586529 capsules|GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
16291837|NCT00703547|Drug|GSK586529 tablets|GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
16291838|NCT00703547|Drug|Placebo|Placebo tablets and capsules will be provided to subjects.
16291839|NCT00703534|Drug|AZD3355|Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
16291840|NCT00703534|Drug|Placebo|capsule. administered as a single dose twice daily for 4 weeks
16291841|NCT00703534|Drug|Gelusil®|Chewable tablets taken as needed
16291842|NCT00703521|Biological|Rabies vaccine|1.0 mL IM day 0,7,28 and 1 year
16291843|NCT00703508|Drug|Metformin 500 mg tablet|Metformin 500 mg tablets; two tablets every 12 hours for 9 months
16291844|NCT00703495|Device|transcranial oxygen saturation measurement (INVOS Somanetics 5100C)|rSO2 measurement
16291845|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate pbo/CoQ10 placebo
16291846|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate pbo/CoQ10 200 mg
16291847|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate 160mg/CoQ10 placebo
16291848|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate 80/CoQ10 100 mg
16291849|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate 160mg/CoQ10 100 mg
16291850|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate 80 /CoQ10 200 mg
16291851|NCT00703482|Drug|Fenofibrate/CoQ10|Fenofibrate 160mg/CoQ10 200 mg
16291852|NCT00703469|Drug|MDX1106-02|Single dose
16291853|NCT00703469|Drug|Placebo|Placebo single dose
16291854|NCT00703456|Behavioral|Balance Training|balance training three days per week for 4 weeks during single limb standing
16291855|NCT00703430|Drug|Memantine|Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.
16291856|NCT00703417|Device|magnetic Resonance Imaging|MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
16291857|NCT00703417|Device|Computed Tomography|CT scan of the lower back and hip
16291858|NCT00703417|Device|High resolution peripheral quantitative computed tomography|HR-pQCT of the distal radius and distal tibia
16291859|NCT00703391|Drug|AZD9668|30mg oral tablets twice daily (bid) for 14 days
16291860|NCT00703391|Drug|Placebo|Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
16291861|NCT00703378|Drug|Docetaxel (Taxotere®)|Phase 1 Cycle 1 and 2 Patients in group 1 receive 40mg/m2/week of docetaxel in a 1-hour infusion. Patients in group 2 receive 30mg/m2/week of docetaxel in a 1-hour infusion. Patients in group 3 receive 20mg/m2/week of docetaxel in a 1-hour infusion.
16291862|NCT00703365|Drug|Sorafenib and Gemcitabine|Sorafenib 400 mg po bid daily and Gemcitabine IV 1,000 mg/m2 on day 1,8, 15 of a 28-day cycle (up to 6 cycles), then followed by Sorafenib 400 mg po bid daily maintenance until disease progression.
16291863|NCT00703352|Drug|Eplerenone|Eplerenone (coated tablet) 50mg daily during 12 months.
16291864|NCT00703339|Drug|Treprostinil sodium for inhalation|"Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose
~Dose:
~Cohort 1: dosed at 3 breaths (18 mcg)
~Cohort 2: dosed at 6 breaths (36 mcg)
~Cohort 3: dosed at 9 breaths (54 mcg)
~Cohort 4: dosed at 12 breaths (72 mcg)
~The decision to advance to the next cohort will be made after review of all safety information including vital signs, physical examination, clinical laboratory tests, ECGs, and adverse events."
16291865|NCT00703326|Biological|ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
16291866|NCT00703326|Drug|docetaxel|Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
16291867|NCT00703326|Other|Placebo|Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
16291868|NCT00703313|Drug|1.5% levofloxacin ophthalmic solution|1 drop instilled at each visit
16291869|NCT00703313|Drug|0.5% moxifloxacin hydrochloride ophthalmic solution|1 drop instilled at each visit
16291873|NCT00703300|Other|pharmacological study|Correlative studies
16291875|NCT00703287|Other|Physiotherapy|Specialized physiotherapy programme developed by Jean-Pierre Bleton
16291876|NCT00703287|Other|Physiotherapy|Generic physiotherapy
16291877|NCT00703274|Behavioral|PROTECT DC|PROTECT DC facilitates the initiation of secondary prevention behaviors in an attempt to prevent the recurrence of stroke among participants. The program trains a lay person, called a stroke navigator, to provide participants with education on secondary prevention behavior and to navigate the health and human service system, which will assist participants in obtaining the necessary services and programs to engage in secondary prevention behaviors.
16291878|NCT00703261|Drug|atorvastatin|Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.
16291879|NCT00703261|Drug|placebo|Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.
16291880|NCT00703248|Procedure|Osteopathic Manipulative Treatments|"opening the thoracic inlet
~pectoral traction for 1 minute bilaterally
~rib raising for a total of 4 minutes- 2 minutes on each side of the thoracic spine ]
~thoracic pump at a rate of 60 times per minute for a total of 5 minutes bilaterally
~abdominal pump at a rate of 30 times per minute for a total of 5 minutes bilaterally."
16291881|NCT00703235|Drug|Bevacizumab|
16291882|NCT00703222|Biological|SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP|"SJNB-JF-IL2 and SJNB-JF-Lptn at 1 x 10^7 cells/m2
~SKNLP at 1 x 10^6 cells/m2"
16291883|NCT00703222|Biological|SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP|"SJNB-JF-IL2 and SJNB-JF-Lptn at 1 x 10^7 cells/m2
~SKNLP at 1 x 10^7 cells/m2"
16291884|NCT00703209|Procedure|Nerve Decompression|"Nerve decompression on a randomized leg, with similar skin incisions on the opposite leg so that the patient is blinded to which leg received the decompression."
16291885|NCT00703196|Dietary Supplement|folic acid|Given orally once daily
16291886|NCT00703196|Other|placebo|Given orally once daily
16291887|NCT00703183|Drug|ACU-4429|administered as a single dose, orally
16291888|NCT00703183|Drug|matching placebo|administered as a single dose, orally
16291889|NCT00703170|Drug|Temsirolimus|
16291890|NCT00703170|Drug|Pegylated liposomal doxorubicin|
16291891|NCT00703157|Procedure|Catheter Ablation|Patients undergoing left atrial circumferential pulmonary vein ostia ablation.
16291892|NCT00703157|Procedure|Surgical Ablation|patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery.
16291893|NCT00703144|Drug|piperacillin/tazobactam|piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days
16291894|NCT00703144|Procedure|Pharmacokinetic|
16291895|NCT00703131|Device|Anal Fistula Plug (SurgiSIS AFP)|Anal Fistula Plug
16291896|NCT00703118|Drug|Telaprevir|Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.
16291897|NCT00703118|Drug|Peg-IFN-alfa-2a|Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
16291898|NCT00703118|Drug|Ribavirin|Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
16291899|NCT00703118|Drug|Placebo|Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
16291900|NCT00703105|Biological|DC vaccination|DC vaccination with 1 x 10(6th) tumor lysate or tumor peptides and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals; (6 weeks)
16291901|NCT00703092|Drug|Fiber-Stat|Liquid fiber supplement, 2 tablespoons twice daily.
16291902|NCT00703079|Drug|Octreotide-LAR or lanreotide|Treated with octreotide-LAR will be given at dosages of 10-40 mg/q28d and treatment with lanreotide-SR at dosages of 60-120 mg/q28d. The dosages are up-titrated to control GH and IGF-I levels
16291903|NCT00703079|Procedure|Transsphenoidal adenomectomy|Removal of pituitary adenomas via one-nostril transsphenoidal approach and endoscopy-assisted.
16291904|NCT00703066|Biological|GMZ 2 vaccine (GLURP + MSP 3)|three doses of 30µg of GMZ 2 vaccine,
16291905|NCT00703066|Biological|GMZ 2 vaccine (GLURP + MSP 3)|100 µg of GMZ 2 vaccine
16291906|NCT00703066|Biological|Rabies vaccine|3 doses of Rabies vaccine
16291907|NCT00703053|Biological|A/Vietnam/1203/04|Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
16291908|NCT00703053|Biological|A/Indonesia/05/05|Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
16291909|NCT00703014|Drug|Corifollitropin Alfa 150 μg|In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
16291910|NCT00703014|Biological|200 IU RecFSH/Follitropin beta (Days 1 to 7)|In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16291911|NCT00703014|Drug|Placebo for Corifollitropin Alfa|In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.
16291912|NCT00703014|Drug|Placebo for RecFSH/Follitropin beta|In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16291913|NCT00703014|Biological|200 IU RecFSH/Follitropin beta (Days 8 to hCG)|In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
16291914|NCT00703014|Drug|Ganirelix|In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.
16291915|NCT00703014|Biological|hCG|In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
16291996|NCT00702546|Biological|open-label recFSH|Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
16291916|NCT00703014|Biological|Progesterone|In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
16291917|NCT00703001|Behavioral|Educational Intervention|students in this arm will receive several oral health educational modules in class
16291918|NCT00703001|Behavioral|Referral Intervention|Parents of enrolled children will receive assistance in accessing oral health care for their child
16291919|NCT00702988|Drug|Org 36286|single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
16291920|NCT00702988|Drug|recFSH|150 IU recFSH daily (reference group administered under protocol 38826)
16291921|NCT00702975|Drug|Paclitaxel, Carboplatin and Bevacizumab,Erlotinib|4 cycles (or less in case of progression) with carboplatin AUC 6 -paclitaxel 200mg/m2 -bevacizumab 15 mg/kg i.v. At (early) progress Bevacizumab 15 mg/kg i.v. q 21 days plus Erlotinib 150 mg/day orally
16291922|NCT00702962|Drug|Vorinostat, Carboplatin, Etoposide|"Study originally a Phase I standard dose escalation of the study medication Vorinostat with sequential cohorts of 3-6 participants entered to 3 dose levels (200mg, 300mg, 400mg). Dose escalation stopped after participant 1 on dose level 2 due to recently published research identifying an appropriate dosing regimen. A set dose was then to be administered to all subsequent participants. This regimen (a cycle) consisted of Vorinostat on Day 1 through Day 4, Carboplatin AUC 6 on Day 3, and Etoposide 100 mg/m2 on Day 3 through Day 5. Treatment cycles were repeated every 21 days (3 weeks) for 4 cycles total."
16291923|NCT00702949|Drug|pregabalin|Given orally
16291924|NCT00702949|Other|placebo|Given orally
16291925|NCT00702936|Drug|TELMISARTAN|80 mg daily
16291926|NCT00702936|Drug|RAMIPRIL|5 mg daily
16291927|NCT00702923|Drug|Bicalutamide and CP-675,206 (Tremelimumab)|"Dose level -1 :
~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"
16291928|NCT00702923|Drug|Bicalutamide, CP-675,206 (tremelimumab)|"Dose level 1:
~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"
16291929|NCT00702923|Drug|Bicalutamide, CP-675,206 (Tremelimumab)|"Dose level 2:
~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"
16291930|NCT00702923|Drug|Bicalutamide, CP-675,206 (Tremelimumab)|"Dose level 3:
~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"
16291931|NCT00702923|Drug|Bicalutamide, CP-675,206|"Final Dose Level:
~Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112
~At month 9, if evidence of PSA progression:
~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29"
16291932|NCT00702910|Drug|Placebo|comparator
16291933|NCT00702910|Drug|GW642444|investigational drug or placebo
16291934|NCT00702910|Drug|Magnesium Stearate|Magnesium Stearate
16291935|NCT00702884|Drug|sunitinib malate|Sunitinib 37.5 mg daily for a 4 week cycle
16291936|NCT00702871|Drug|Ranitidine|In arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay.
16291937|NCT00702871|Drug|Sucralfate|In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
16291938|NCT00702858|Drug|Blue Citrus|Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
16291939|NCT00702858|Drug|Placebo|Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
16291940|NCT00702845|Drug|corifollitropin alfa (Org 36286)|100 µg corifollitropin alfa subcutaneous (SC) injection
16291941|NCT00702845|Drug|recFSH (follitropin beta)|150 IU recFSH SC injection
16291942|NCT00702845|Drug|gonadatropin releasing hormone (GnRH) antagonist (ganirelix)|GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day
16291943|NCT00702845|Drug|human chorion gonadatropin (hCG)|hCG 5,000 IU or 10,000 IU administered SC
16291944|NCT00702845|Biological|progesterone|Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
16291945|NCT00702845|Drug|placebo-recFSH (follitropin alfa)|Placebo-recFSH administered at the equivalent volume of 150 IU/day.
16291946|NCT00702845|Drug|placebo-corifollitropin alfa|Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.
16291947|NCT00702845|Biological|open-label recFSH|Open-label recFSH administered up to a maximum dose of 200 IU/day.
16291948|NCT00702832|Behavioral|Vestibular rehabilitation|Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.
16291949|NCT00702832|Other|standard treatment|treatment as usual
16291950|NCT00702819|Drug|Bevacizumab|Dosage of 0.75mg/0.03ml injectable, one time only.
16291951|NCT00702806|Drug|Org 36286|Intra-abdominal injection of Org 36286
16291952|NCT00702806|Drug|Puregon®|Subcutaneous Puregon® 150 IU
16291953|NCT00702806|Drug|Orgalutran®|Subcutaneous Orgalutran® 0.25 mg
16291954|NCT00702806|Drug|Pregnyl®|Subcutaneous Pregnyl® 10,000 IU
16291955|NCT00702793|Drug|Varenicline|Varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. Administration of twice daily dosing should be at least 8 hours apart.
16291956|NCT00702780|Drug|escitalopram|5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
16291957|NCT00702780|Drug|placebo|5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
16291958|NCT00702767|Drug|INTRALIPIDS|INTRAVENOUS FAT EMULSIONS
16291959|NCT00702754|Biological|Botulinum Toxin Type B|Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.
16291960|NCT00702741|Drug|Chondrogen|Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
16291961|NCT00702741|Drug|Chondrogen|Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
16291962|NCT00702741|Drug|Placebo|Intra-articular injection of Hyaluronan
16291963|NCT00702728|Drug|Furosemide and matched saline hydration|Subjects will begin treatment approximately 90 minutes prior to the start of catheterization procedure. After a pre-hydration bolus of 250 ml of normal saline solution over 30 minutes the patient will receive 0.5 mg/kg of furosemide intravenously. Then, a replacement solution (saline) is given in an amount matched (ml for ml) to the volume of urine produced. Matched hydration will occur prior, during, and 4 hours post procedure.
16291964|NCT00702728|Drug|isotonic saline solution|Subjects will receive 1 ml/Kg/hr of intravenous saline solution for a minimum of 12 hours prior to catheterization. Hydration will continue to occur during the catheterization, and for a minimum of 12 hours post catheterization.
16291965|NCT00702715|Drug|sugammadex|"Each subject will receive an
~intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After
~this dose, maintenance doses of 0.1 - 0.2 mg.kg-1
~rocuronium may be given. In case of maintenance dosing, the target depth of
~neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC."
16291966|NCT00702702|Drug|Proellex 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
16291967|NCT00702702|Drug|Proellex 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
16291968|NCT00702702|Drug|Placebo|Placebo, 2 capsules daily for 3 months
16291969|NCT00702689|Drug|Gleevec, STI571(Imatinib Mesylate)|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.
~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
16291970|NCT00702676|Drug|Quetiapine Fumarate|Tablet, Oral, once daily
16291971|NCT00702676|Drug|Quetiapine Fumarate|Tablet, Oral, once daily
16291972|NCT00702650|Drug|Testosterone MD-Lotion|30 mg to 120 mg administered topically once daily for 120 days
16291973|NCT00702637|Drug|Modafinil|
16291974|NCT00702624|Drug|Corifollitropin alfa|Single injection of 100 μg corifollitropin alfa administered under protocol P05690
16291975|NCT00702624|Biological|recFSH (follitropin beta)|Daily recFSH administered under protocol P05690
16291976|NCT00702624|Drug|gonadatropin releasing hormone (GnRH) antagonist ganirelix|GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
16291977|NCT00702624|Biological|human chorion gonadotropin (hCG)|hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
16291978|NCT00702624|Biological|progesterone|Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
16291979|NCT00702624|Drug|placebo-recFSH (follitropin beta)|Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
16291980|NCT00702624|Drug|placebo-corifollitropin alfa|Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
16291981|NCT00702624|Biological|open-label recFSH (follitropin beta)|Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
16291982|NCT00702611|Device|Granulocyte Monocyte Apheresis (GMA-Apheresis)|GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
16291983|NCT00702598|Behavioral|Telephone-based Cognitive Behaviour Therapy (CBT)|Telephone-based CBT: Eight sessions of telephone-based CBT (Tel-CBT) will be delivered over 8-10 weeks, based on a published manual (Simon et al, 2004). Tel-CBT has been modified to be briefer than traditional CBT (30-40 minutes instead of 60 minutes per session) and will be offered at convenient times (including evening sessions). The initial Tel-CBT session will occur within 2 weeks of randomization, with subsequent sessions occurring every 1-2 weeks depending on scheduling and patient preference. The initial session focuses on motivation enhancement exercises, subsequent sessions emphasize identifying, challenging and distancing from negative thoughts, and the final session focuses on a personal care plan and self-management skills.
16291984|NCT00702598|Behavioral|Telephone reminder calls|Telephone reminder calls: Weekly telephone calls for 8 weeks to inquire on progress and remind patients to take their medications properly
16291985|NCT00702585|Drug|Org 36286|Org 36286 single-dose subcutaneous injection
16291986|NCT00702585|Drug|Placebo|Placebo to Org 36286 as a single-dose subcutaneous injection
16291987|NCT00702572|Drug|Vorinostat, Bevacizumab, Carboplatin, Paclitaxel|This dose escalating phase will enroll sequential cohorts of 3-6 patients to be entered at the following dose levels: Level -1: Days 1-14, Vorinostat 100 mg po QD; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 175 mg/m2. Level 1: Days 1-14, Vorinostat 200 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 2: Days 1-14, Vorinostat 300 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 3: Days 1-14, Vorinostat 400 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Treatment cycles will be repeated every 3 weeks. The highest dose level which <2 out of 5 patients experience dose limiting toxicity will be defined as the recommended phase II dose.
16291988|NCT00702572|Drug|Vorinostat, Bevacizumab, Carboplatin, Paclitaxel|Once the recommended phase II dose has been established from Phase I, 12 additional patients will be treated to evaluate the toxicities and safety profile of the 4-drug regimen.
16291989|NCT00702546|Drug|corifollitropin alfa|Single injection of 100 μg corifollitropin alfa administered under protocol P05690
16291990|NCT00702546|Biological|recFSH (follitropin alfa)|Daily recFSH administered under protocol P05690
16291991|NCT00702546|Drug|gonadatropin releasing hormone (GnRH) antagonist ganirelix|GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
16291992|NCT00702546|Drug|human chorion gonadatropin (hCG)|hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
16291993|NCT00702546|Biological|progesterone|Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
16291994|NCT00702546|Drug|placebo-recFSH (follitropin alfa)|Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
16291995|NCT00702546|Drug|placebo-corifollitropin alfa|Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
16291997|NCT00702520|Drug|Corifollitropin alpha (MK-8962, Org 36286) 100 ug|Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
16291998|NCT00702520|Drug|Corifollitropin alpha (MK-8962, Org 36286) 150 ug|Subcutaneous administration of corifollitropin alpha at a dose of 150 ug
16291999|NCT00702520|Drug|Triptorelin|Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
16292000|NCT00702520|Biological|Recombinant follicle stimulating hormone (recFSH)|From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
16292001|NCT00702520|Biological|Human chorionic gonadotprophin (hCG).|HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
16292002|NCT00702507|Drug|0.25 % Miconazole Nitrate Ointment|Topical Application
16292003|NCT00702494|Biological|TB-403|Multiple IV
16292004|NCT00702481|Drug|Nimotuzumab|Patients will receive nimotuzumab 200 mg weekly for 8 weeks. Nimotuzumab will be started together with concurrent chemoradiation, and continued 1 week after the completion of chemoradiation.
16292005|NCT00702481|Drug|Cisplatin|Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.
16292006|NCT00702481|Radiation|Radiation|Concurrent radiotherapy will be given to the primary tumor and upper neck at 2 Gy per fraction, once a day, five days a week to a total of 70 Gy in 35 fractions in seven weeks.
16292007|NCT00702468|Drug|Sativex|containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief
16292008|NCT00702468|Drug|Placebo|Contains no active drug and is delivered in 100 microlitre actuations by a pump action oromucosal spray
16292009|NCT00702455|Behavioral|Self-Directed (weight loss maintenance)|Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach in two sessions.
16292010|NCT00702455|Behavioral|Guided (weight loss maintenance)|Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their weight gain.
16292011|NCT00702442|Drug|Droperidol|0.625 mg droperidol administrated i.v prior to laparoscopic cholecystectomy
16292012|NCT00702442|Drug|Saline solution|Saline solution administrated i.v 30 min prior surgery
16292013|NCT00702429|Other|Blood sampling|Analysis of the PNN, analysis of the monocytes
16292014|NCT00702429|Other|Blood sampling|Analysis of the PNN, analysis of the monocytes
16292015|NCT00702416|Procedure|Ultrasound-guided continuous interscalene brachial plexus block|"With patients in the supine position, a high-frequency (10-12 MHz) ultrasound transducer in a sterile sheath will be applied to explore the interscalene region and locate the brachial plexus. The transducer will be positioned so as to image the C5 and C6 roots in a single view. Visualization of the C7 root in the same scan will be sought, but will not be required.
~A 50-mm, 20 G needle will be advanced in-plane from the postero-lateral side of the transducer. Injection of the local anesthetic will be performed in small aliquots while repositioning of the needle in order to optimize spread of the injectate around the nerve roots.
~At the end of the injection, a catheter will be threaded through the needle. The catheter will be positioned to lie deep and close to the imaged nerve roots."
16292016|NCT00702416|Procedure|Continuous interscalene brachial plexus block using electrical nerve stimulation|"With patients in the supine position, the head will be rotated to the contralateral side. The interscalene groove will be palpated.
~A 35-mm, 20 G needle will be inserted at the estimated C6 level (cricoid cartilage) with a 30-45° angle to the skin. The needle will be advanced along a line joining the insertion site to the axilla.
~An electrical nerve stimulator will be used at an initial intensity of 1.0 mA (frequency: 2 Hz, pulse width: 0.2 ms). A musculocutaneous or axillary-nerve mediated twitch will be sought
~Injection of the local anesthetic will start with a visible motor response at a current <0.5 mA. The catheter will be positioned to as to elicit a motor response at ≤0.4 mA."
16292017|NCT00702416|Drug|Ropivacaine|"Block induction [1% (wt/vol) solution]:
~20 ml (200 mg)
~Postoperative analgesia [0.2% (wt/vol) solution]:
~Background infusion: 4 ml/h (8 mg/h)
~Incremental on-demand dose: 2 ml (4 mg)
~Lockout time: 15 min"
16292018|NCT00702416|Drug|Paracetamol|1 g iv q8h
16292019|NCT00702416|Drug|Morphine|5 mg im prn q1h (in the postoperative period)
16292020|NCT00702416|Drug|Fentanyl|50 µg iv prn (in the intraoperative period)
16292021|NCT00702416|Procedure|General anesthesia|"Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure.
~The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia care will also be acceptable; the block will be considered as failed in that case as well."
16292022|NCT00702403|Drug|nilotinib|Given PO
16292023|NCT00702403|Drug|imatinib mesylate|Given PO
16292024|NCT00702403|Other|pharmacological study|Correlative studies
16292025|NCT00702377|Other|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
16292026|NCT00702377|Other|Optive|Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
16292027|NCT00702364|Drug|atomoxetine|
16292028|NCT00702364|Drug|placebo|
16292029|NCT00702351|Drug|Org 36286 (corifollitropin alfa)|A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing >= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing <= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
16292030|NCT00702338|Drug|corifollitropin alfa|SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
16292031|NCT00702338|Biological|recombinant Follicle Stimulating Hormone (recFSH)|Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
16292032|NCT00702338|Biological|human Chorion Gonadotropin (hCG)|Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
16292033|NCT00702338|Biological|hCG Bolus injection|Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.
16292034|NCT00702325|Drug|Budesonide / formoterol fumarate (SYMBICORT)|160/4.5 μg x 2 actuations twice daily (bid)
16292035|NCT00702325|Drug|Budesonide|inhalation powder 180 μg x 2 inhalations bid (PULMICORT)
16292036|NCT00702312|Behavioral|Low-salt educational programme|Subjects will attend a health promotion cooking programme and receive written tailored low-salt Bengali educational tool. This tool has been developed specifically for this population group from Phase 1 and 2 study.
16292037|NCT00702312|Behavioral|Low-salt Bangladeshi educational programme|A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.
16292038|NCT00702312|Behavioral|Low-salt Bangladeshi educational programme|A multi-component Low-salt educational programme tailored to the Bangladeshi kidney disease patients residents in Tower Hamlets delivered over 5 months.
16292039|NCT00702299|Drug|cisplatin|IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles
16292040|NCT00702299|Drug|paclitaxel|IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles
16292041|NCT00702299|Drug|pemetrexed disodium|Escalate doses in groups of 3 patients to 60mg per m2, 120 mg per m2, 500 mg per m2, 750 mg per m2, 1000 mg per m2
16292042|NCT00702299|Other|biologic sample preservation procedure|Plasma samples will be collected on the 1st course at baseline, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours (if possible) and 24 hours after the first IP Alimta® dose.
16292043|NCT00702273|Drug|150 µg Corifollitropin Alfa|On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
16292044|NCT00702273|Biological|200 IU RecFSH/Follitropin beta (Days 1 to 7)|Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16292045|NCT00702273|Drug|Placebo for Corifollitropin Alfa|Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
16292046|NCT00702273|Drug|Placebo for RecFSH/Follitropin beta|Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16292047|NCT00702273|Biological|200 IU RecFSH/Follitropin beta (Days 8 to hCG)|From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
16292048|NCT00702273|Drug|Ganirelix|On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
16292049|NCT00702273|Biological|hCG|When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
16292050|NCT00702273|Biological|Progesterone|On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
16292051|NCT00702260|Drug|Ramipril|10 mg capsule
16292052|NCT00702247|Procedure|Hematopoietic Stem Cell Transplantation|
16292053|NCT00702234|Biological|Corifollitropin alfa|Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
16292054|NCT00702234|Biological|GnRH antagonist|SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
16292055|NCT00702234|Biological|(rec)hCG|SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
16292056|NCT00702234|Biological|FSH|SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
16292057|NCT00702234|Drug|Progesterone|Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.
16292058|NCT00702221|Biological|Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant|Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant given as 3 separate intramuscular injections into the arm, 21 days apart
16292059|NCT00702221|Biological|CoVaccine HT™ adjuvant|Given as three separate intramuscular injections into the arm, 21 days apart
16292060|NCT00702208|Device|Delphi Screener|Self-sampling device for cervical vaginal lavage
16292061|NCT00702195|Drug|Org 36286 (corifollitropin alfa)|single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
16292062|NCT00702195|Drug|Placebo|single dose of placebo (administered under protocol 38805)
16292063|NCT00702195|Drug|recFSH|150 IU recFSH daily (reference group administered under protocol 38807)
16292064|NCT00702182|Drug|Vinorelbine (Navelbine)|Conventional Schedule Oral Vinorelbine on day 1 and day 8 of a 21 day schedule
16292065|NCT00702182|Drug|Vinorelbine (Navelbine)|Metronomic Schedule Oral Vinorelbine 3 times a week
16292066|NCT00702182|Drug|Erlotinib|Daily Oral Erlotinib 100 mg
16292067|NCT00702156|Drug|Bisoprolol|Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
16292068|NCT00702156|Drug|Placebo|Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
16292069|NCT00702143|Drug|florbetapir F 18|IV injection, 370MBq (10mCi), single dose
16292076|NCT00702078|Behavioral|closer collaboration between hospital and primary healthcare system|Follow-up from the hospital and the primary healthcare in cooperation
16292077|NCT00702078|Behavioral|usual care|follow-up according to todays best practice
16292078|NCT00702052|Drug|Everolimus|Everolimus tablets
16292079|NCT00702039|Other|No Music|No music will be played in patients in arm 2 of the study.
16292080|NCT00702039|Other|Music Therapy|Classical music being played during intravitreal injection.
16292081|NCT00702026|Dietary Supplement|multispecies probiotic (Ecologic 801)|once daily, 5 gram [10e9 cfu/gram]
16292082|NCT00702026|Dietary Supplement|Placebo|once daily, 5 gram [10e9 cfu/gram]
16292083|NCT00701987|Drug|ALS-357|Topical application of ALS-357
16292084|NCT00701974|Biological|collagenase (IRUXOL)|patients will be treated with collagenase one time per day.
16292085|NCT00701974|Biological|collagenase (Kollagenase)|patients will be treated with collagenase one time per day.
16292086|NCT00701961|Drug|Mefloquine-artesunate|Mefloquine-artesunate fixed dose combination comprised of 100 mg of artesunate and 220mg of mefloquine per tablet, developed by DNDi and manufactured by farmanguinhos (Brazil).
16292087|NCT00701935|Drug|placebo|subcutaneous injection, twice a day
16292088|NCT00701935|Drug|exenatide|subcutaneous injection, twice a day, 10mcg
16292089|NCT00701909|Drug|morphine plus saline|During the first wound care procedure, some patients will receive morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS), according to randomization, while other patients will receive morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg
16292090|NCT00701909|Drug|morphine plus ketamine|Patients who received morphine 0.1 mg/kg (maximum dose of 8 mg)plus saline during the first wound care procedure will now receive ketamine 0.25 mg/kg IV plus morphine 0.05 mg/kg
16292091|NCT00701896|Drug|Varenicline tartrate|1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.
16292092|NCT00701896|Drug|Nicotine Replacement Therapy|Nicotine gum and nicotine patch
16292093|NCT00701896|Other|Biological Control|No treatment intervention only information and procedures.
16292094|NCT00701896|Behavioral|Motivational Interview|60 minute one-on-one Interview
16292095|NCT00701883|Drug|Placebo|2 capsules, once a day for 8 weeks
16292096|NCT00701883|Drug|MBX-8025|2 capsules, once daily for 8 weeks
16292097|NCT00701883|Drug|MBX-8025|2 capsule, once daily for 8 weeks
16292098|NCT00701883|Drug|Atorvastatin|2 capsules, once daily for 8 weeks
16292099|NCT00701883|Drug|MBX-8025|2 capsules, once daily for 8 weeks
16292100|NCT00701883|Drug|MBX-8025|2 capsules, once daily for 8 weeks
16292101|NCT00701870|Drug|ezatiostat hydrochloride (Telintra®)|4500 mg orally per day in two divided doses
16292102|NCT00701857|Drug|cisplatin|Standard weekly dose
16292103|NCT00701857|Drug|Pemetrexed|Biweekly pemetrexed dose escalation
16292104|NCT00701857|Radiation|radiation therapy|Weekly standard dose radiation therapy
16292105|NCT00701844|Behavioral|Writing A (Experimental informative writing)|Experimental informative writing
16292106|NCT00701844|Behavioral|Writing B (Experimental noninformative writing)|Experimental noninformative writing
16292107|NCT00701844|Behavioral|Writing C (Control informative writing)|Control informative writing
16292108|NCT00701844|Behavioral|Writing D (Control noninformative writing)|Control noninformative writing
16292109|NCT00701831|Drug|Insulin glargine|The dose is titrated according to patient needs
16292110|NCT00701805|Drug|Paricalcitol|Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
16292111|NCT00701792|Procedure|liver transplantation|liver transplantation
16292112|NCT00701792|Other|standard care for liver disease|"standard care for liver disease included therapy for ascitis (spironolactone, furosemide), portal hypertension (oesophageal varices ; propranolol), encephalopathy (lactulose), and bacterial infections whatever their localization (prophylaxis of spontaneous peritonitis with norfloxacin). All medical or instrumental procedures were allowed. Patients undergoing iterative paracentesis, variceal band ligation or sclerotherapy, peritoneojugular shunt (LeVeen), transjugular intrahepatic portosystemic shunt (TIPS) or surgical portocaval anastomosis were considered as receiving standard medical therapy."
16292113|NCT00701779|Drug|Tamsulosin|Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
16292114|NCT00701766|Drug|BI 2536|
16292115|NCT00701740|Drug|oral isotretinoin and Mexoryl SX / XL|20mg, 3/week,continuously for three months
16292116|NCT00701740|Drug|Mexoryl XL / SX|11 subjects used only the same moisturizer and SPF 60 sunscreen
16292117|NCT00701727|Drug|ezetimibe|1 tablet,10mg, once a day, for 7 weeks
16292118|NCT00701727|Drug|Placebo|1 tablet, once a day, for 7 weeks
16292119|NCT00701714|Drug|HX575 recombinant human erythropoietin alfa|Solution for injection (s.c.)
16292120|NCT00701714|Drug|ERYPO|Solution for injection (s.c.)
16292121|NCT00701701|Biological|Myozyme® (alglucosidase alfa)|Myozyme®: IV infusion of 20 mg/kg qow; Cyclophosphamide: 250 mg/m^2 IV q4w after Myozyme infusion for 6 months.
16292122|NCT00701701|Biological|Myozyme® (alglucosidase alfa)|Myozyme®: IV infusion of 20 mg/kg qow; Rituximab: 375 mg/m^2 IV weekly beginning the day after Myozyme infusion for 4 weeks (an optional additional 2nd cycle could be administered at the discretion of the investigator); Methotrexate: 15 mg/m^2 subcutaneous qow on the day after Myozyme infusion for 6 months.
16292123|NCT00701688|Drug|Palifermin|Dose level 1 40 mcg/kg/day intravenous Dose level 2 60 mcg/kg/day intravenous Dose level 3 90 mcg/kg/day intravenous
16292124|NCT00701675|Drug|sertraline 50 mg daily|50 mg daily
16292125|NCT00701675|Drug|sertraline 100 mg daily|100 mg daily
16292126|NCT00701675|Drug|Placebo 50 or 100 mg|50mg or 100mg matching placebo
16292127|NCT00701662|Biological|Vivaglobin|
16292128|NCT00701649|Biological|CYT006-AngQb|s.c.
16292129|NCT00701649|Biological|Placebo|s.c.
16292130|NCT00701636|Drug|daptomycin|Subjects enrolled in the intervention group will receive a single intravenous administration of daptomycin 8 mg/kg 30-60 minutes prior to surgery (incision). The 500 mg vial will be reconstituted with 10 mL of 0.9% normal saline (NS) and further diluted in 50 mL of 0.9% NS to be given over a 30 minute infusion.
16292131|NCT00701623|Drug|heparin|patients will receive the application of one of two types of heparin directly on the injured area
16292132|NCT00701623|Drug|heparin|patients will receive the application of one of two types of heparin directly on the injured area
16292133|NCT00701623|Drug|folder water|patients will receive the application of folder water directly on the injured area
16292134|NCT00701597|Drug|bosentan|Bosentan (Tracleer 125mg Tabletts), peroral, dose: 500mg for 8 days
16292135|NCT00701571|Procedure|Virtual Reality distraction|"Virtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is Snow World. In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities."
16292136|NCT00701558|Drug|Erlotinib|150 mg po daily
16292137|NCT00701558|Drug|Gemcitabine|1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
16292138|NCT00701532|Drug|Modafinil and PET (brain imaging)|duration 90 days
16292139|NCT00701532|Drug|placebo|duration 90 days
16292140|NCT00701506|Device|Patterned Electrical Neuromuscular Stimulation|"20-minute session, to each affected knee, 3 times per week for 12 weeks.
~PENS for 20 minutes:
~Tri-phasic Lower Extremity stimulation pattern based on activation timing of the quadriceps and hamstrings for strength training (50 Hz impulses for 200 ms every 1500 ms).
~Minimal twitch for 5 minutes.
~Moderate to strong, but well-tolerated twitch contractions for 15 minutes.
~Electrodes placed on quadriceps and hamstrings"
16292141|NCT00701506|Device|Placebo PENS|"20-minute session, to each affected knee, 3 times per week for 12 weeks.
~Placebo PENS for 20 minutes:
~Electrodes placed on quadriceps and hamstrings."
16292142|NCT00701493|Drug|Topiramate oral liquid formulation;Topiramate Sprinkle formulation|
16292143|NCT00701480|Other|skin cleanser contained Hibiscus sabdariffa extract|face washing 2-3 times/day
16292144|NCT00701480|Other|marketed skin cleanser|face washing 2-3 times/day
16292145|NCT00701454|Other|No intervention|No intervention
16292146|NCT00701428|Drug|Losartan|Losartan 50 mg daily during 6 + 6 weeks
16292147|NCT00701428|Other|CPAP|CPAP during the second 6 week-period
16292148|NCT00701415|Biological|Agalsidase beta|Powder for concentrate for solution for infusion 1.0 mg/kg/4 weeks
16292149|NCT00701415|Biological|Agalsidase beta|Powder for concentrate for solution for infusion 0.5 mg/kg/2 weeks
16292150|NCT00701389|Drug|telcagepant potassium|Single oral dose of 2 x 300 mg capsules.
16292151|NCT00701389|Drug|sumatriptan|single oral dose of 100 mg sumatriptan
16292152|NCT00701389|Drug|sumatriptan placebo|single oral dose
16292153|NCT00701389|Drug|telcagepant potassium placebo|single oral dose of 2 MK-0974 placebo capsules
16292154|NCT00701376|Other|liver biopsy|Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss
16292155|NCT00701363|Drug|Lanreotide Autogel 120 mg|120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24
16292156|NCT00701337|Drug|oestradiol|oestradiol 2 mg oral route 30 days
16292157|NCT00701337|Drug|oestradiol|oestradio transdermal patch 60ug by 24 hours 30 days
16292158|NCT00701324|Drug|BI 811283|dose escalation BI 811283, Arm B (3 weeks)
16292159|NCT00701324|Drug|BI 811283|dose escalation BI 811283, Arm A (day 1)
16292160|NCT00701324|Drug|BI 811283|dose escalation BI 811283, Arm A (day 15)
16292161|NCT00701311|Drug|CC-10004|CC-10004 20 mg per day
16292162|NCT00701298|Biological|peginterferon alfa-2b|Given SC
16292163|NCT00701298|Drug|decitabine|Given IV
16292164|NCT00701298|Other|laboratory biomarker analysis|Correlative studies
16292165|NCT00701285|Drug|pitavastatin|pitavastatin 4mg once daily
16292166|NCT00701285|Drug|pravastatin|pravastatin 10mg once daily
16292167|NCT00701259|Drug|Lansoprazole|Lansoprazole 15 mg once per day for 14 days
16292168|NCT00701259|Drug|Lansoprazole|Lansoprazole 30 mg once per day for 14 days
16292169|NCT00701259|Drug|placebo|
16292170|NCT00701246|Drug|ferrous sulfate|
16292171|NCT00701246|Drug|folic acid|
16292172|NCT00701246|Drug|placebo (folic acid)|
16292173|NCT00701233|Drug|Botulinum toxin|45 units Botox injected into Carpal Tunnel once
16292174|NCT00701233|Drug|Corticosteroid injection into Carpal Tunnel|40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
16292175|NCT00701220|Drug|Atorvastatin Calcium|Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.
16292176|NCT00701207|Drug|nicotine patch|daily transdermal patch 7 mg, 14mg, 21 mg. 3 months
16292177|NCT00701194|Behavioral|Early Intervention Foster Care (EIFC)|The EIFC/MTFC-P intervention is delivered through a treatment team approach. Foster parents receive preservice training and ongoing consultation from program staff. Children receive individual therapy and attend a therapeutic playgroup. The intervention emphasizes the use of concrete encouragement for prosocial behavior; consistent, nonabusive limit-setting to address disruptive behavior; and close supervision of the child. The EIFC intervention employs a developmental framework in which the challenges of foster preschoolers are viewed from the perspective of delayed maturation and is oriented toward creating optimal environmental conditions to facilitate developmental progress. These conditions include a responsive and consistent caregiver and a predictable daily routine.
16292178|NCT00701181|Procedure|Laser Treatment|Necessity of laser treatment is assessed every three months.
16292179|NCT00701181|Drug|PF-04523655 high|3 mg intravitreal injection
16292180|NCT00701181|Drug|PF-04523655 middle|1 mg intravitreal injection
16292181|NCT00701181|Drug|PF-04523655 low|0.4 mg intravitreal injection
16292182|NCT00701168|Device|yttrium Y 90 microspheres (Therasphere®)|This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.
16292183|NCT00701155|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the actual clinical evaluation
16292184|NCT00701142|Biological|Haemocomplettan® P|Single intravenous infusion
16292186|NCT00701129|Biological|Alglucosidase Alfa|Administered as IV infusion.
16292187|NCT00701129|Drug|Methotrexate|Administered subcutaneously.
16292188|NCT00701129|Drug|Rituximab|Administered as IV infusion.
16292189|NCT00701103|Drug|Dalotuzumab|IV infusion
16292190|NCT00701090|Drug|sitagliptin|Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
16292191|NCT00701090|Drug|Comparator: glimepiride|glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
16292192|NCT00701090|Drug|open-label metformin|open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
16292193|NCT00701077|Drug|3,4-Di-amino-Pyridine|a single 20 mg dosing
16292194|NCT00701077|Drug|placebo|placebo
16292195|NCT00701064|Other|Bright Light Exposure|Administered via bright light box
16292196|NCT00701064|Other|Negative Ion Generator|Administered via Negative Ion Generatore
16292197|NCT00701051|Behavioral|Aerobic exercise training|24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity
16292198|NCT00701051|Behavioral|Detraining (cessation of exercise)|Cessation of exercise for 2 weeks
16292199|NCT00701038|Device|auto adjusting bi-level positive airway pressure device|auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
16292200|NCT00701012|Procedure|preservation of nerve fibers around IMA|low ligation
16292201|NCT00701012|Procedure|resection of nerve fibers around IMA|high ligation
16292202|NCT00700999|Drug|Paroxetine|Paroxetine 20-40mg po QD for 12 weeks
16292203|NCT00700986|Drug|AZD9056|Oral tablet, 800mg, one single administration
16292204|NCT00700986|Drug|Placebo|Single dose
16292205|NCT00700973|Behavioral|Interpersonal Violence Prevention Intervention|This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change.
16292206|NCT00700973|Other|Usual care|Substance use disorder usual care
16292207|NCT00700960|Drug|insulin detemir|initiation of an long acting insulin treatment in association with OAD at the discretion of the physician/diabetologist
16292208|NCT00700947|Drug|Beta-blocker therapy (TOPROL-XL® )|Patients who are asymptomatic with normal left ventricular systolic function and wish to be medically treated for severe primary mitral regurgitation with Beta-blocker.
16292209|NCT00700921|Drug|Lovastatin|40mg po once daily
16292210|NCT00700921|Drug|Placebo|One capsule, once daily
16292211|NCT00700908|Behavioral|automated telephone intervention vs. usual care|
16292212|NCT00700895|Drug|Warfarin Sodium|All predicted warfarin dose will be administered by rounding down to the nearest 0.5 mg. Warfarin (Marevan®) is available as 1mg (brown), 3 mg (blue) and 5 mg (pink) oral tablets from GlaxoSmithKline Pte. Ltd.
16292213|NCT00700882|Drug|dasatinib|Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
16292214|NCT00700869|Procedure|mechanical ventilation|mechanical ventilation
16292215|NCT00700856|Drug|add-on pioglitazone|participants randomised to this arm will add pioglitazone 15 mg/die to therapy with metformin (2 gr/die)
16292216|NCT00700856|Drug|add-on sulphonylurea|participants randomized to this arm will add a sulphonylurea (glibenclamide 5 mg/die; gliclazide 30 mg/die or glimepiride 2 mg/die)to monotherapy with metformin (2 gr/die)
16292217|NCT00700830|Drug|insulin detemir|Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation
16292218|NCT00700817|Drug|liraglutide|1.2 mg once daily, subcutaneous (under the skin) injection
16292219|NCT00700817|Drug|sitagliptin|Tablets, 100 mg daily
16292220|NCT00700817|Drug|metformin|Tablets, minimum 1500 mg daily
16292221|NCT00700817|Drug|liraglutide|1.8 mg once daily, subcutaneous (under the skin) injection
16292222|NCT00700804|Behavioral|High Protein Diet|High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
16292223|NCT00700804|Behavioral|Low Protein Diet|High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
16292224|NCT00700791|Dietary Supplement|Natural Vitamin E Tocotrienol supplement (TCT)|Oral Vitamin E Tocotrienol Supplement (TCT)
16292225|NCT00700791|Device|Natural Vitamin E Tocotrienol Cream (TCT)|Natural Vitamin E Tocotrienol(TCT)Topical Cream
16292226|NCT00700791|Other|Placebo|Oral Placebo
16292227|NCT00700791|Other|Placebo Cream|Topical Placebo Cream
16292228|NCT00700778|Biological|recombinant human chorionic gonadotropin|
16292229|NCT00700778|Genetic|microarray analysis|
16292230|NCT00700778|Other|immunohistochemistry staining method|
16292231|NCT00700778|Other|laboratory biomarker analysis|
16292232|NCT00700778|Procedure|needle biopsy|
16292233|NCT00700765|Drug|insulin detemir|For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
16292234|NCT00700752|Device|senofilcon A|silicone hydrogel contact lens
16292235|NCT00700752|Device|balafilcon A|silicone hydrogel contact lens
16292236|NCT00700739|Device|DISCOVER™ Artificial Cervical Disc|DISCOVER™ Artificial Cervical Disc
16292237|NCT00700739|Device|ACDF|Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft
16292238|NCT00700713|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate|0.5 mL, IM
16292239|NCT00700713|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate|0.5 mL, IM
16292240|NCT00700713|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate|0.5 mL, IM
16292241|NCT00700700|Device|Active Cardiac Resynchronization Therapy (CRT)|"Initiation of active biventricular pacing/cardiac resynchronization therapy
~Devices by Medtronic:
~Insync Sentry 7298 & 7299
~Concerto C174 ASK (Most frequently implanted)
~Insync III 8042 (PM)
~Devices by Guidant/Boston Scientific:
~Contak Renewal 4 H190 & H199
~Contak Renewal 3 H127
~Devices by ELA/Sorin:
~1. Ovatio CRT 6750"
16292242|NCT00700687|Drug|PA32540|aspirin/omeprazole
16292243|NCT00700687|Drug|PA32540 and celecoxib|aspirin/omeprazole and celecoxib
16292244|NCT00700687|Drug|aspirin and [NSAID]|aspirin and [NSAID]
16292245|NCT00700661|Drug|montelukast|One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
16292246|NCT00700661|Drug|placebo (unspecified)|Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks
16292247|NCT00700648|Drug|insulin aspart|Intravenous NovoRapid dose & frequency as decided by treating physician
16292248|NCT00700635|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate|0.5 mL, 2 doses Intramuscular
16292249|NCT00700635|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate|0.5 mL, 2 doses Intramuscular
16292250|NCT00700635|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate|0.5 mL, 1 dose Intramuscular
16292251|NCT00700622|Drug|Technosphere Insulin|Technosphere Insulin Inhalation Powder 15U or 30U
16292252|NCT00700622|Drug|Insulin glargine|Lantus-injectible supplied as 3mL (300 units) pens
16292253|NCT00700622|Drug|Insulin lispro|Humalog autopen cartridges pre-filled with 3mL (300 units)
16292254|NCT00700609|Behavioral|Attachment Based Family therapy (ABFT)|Attachment-Based Family Therapy (ABFT) is a brief manualized therapy designed exclusively for depressed adolescents and aims at reducing adolescent depression by improving family communication and trust.
16292255|NCT00700596|Drug|Salvinorin A|Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg
16292256|NCT00700596|Drug|Placebo|Control or Placebo SA (30 % ethanolic solution)
16292257|NCT00700583|Drug|combination therapy of terazosin and hydrochlorothiazide|25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks
16292258|NCT00700570|Drug|bevacizumab [Avastin]|5mg/kg iv on day 1 of each 2 week cycle.
16292259|NCT00700570|Drug|capecitabine [Xeloda]|1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle
16292260|NCT00700570|Drug|oxaliplatin|85mg/m2 iv on day 1 of each 2 week cycle
16292261|NCT00700557|Dietary Supplement|Probiotics - Lactobacillus casei and Bifidobacterium breve|Experimental group:This group received enteral tube feeding or oral diet plus a juice containing 1 sachet (1g) of probiotics (Lactobacillus casei and Bifidobacterium breve - 6x 108 UFC/g) three times a day.
16292262|NCT00700557|Dietary Supplement|Maize starch|Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.
16292263|NCT00700544|Drug|chemotherapy treatment (see arm) + norethandrolone|"oral form
~Dosage:
~10 mg in patients with a weight < 60 kgs 20 mg in patients with a weight > 60 kgs frequency: every day Duration: 2 years"
16292264|NCT00700544|Drug|chemotherapy treatment (see arms)|Induction chemotherapy + maintenance chemotherapy
16292265|NCT00700531|Device|FLC removal HD (Gambro HCO 1100)|FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100
16292266|NCT00700531|Procedure|Standard dialysis on a high flux ployflux dialyser|Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
16292267|NCT00700518|Drug|placebo cream|placebo cream applied to 2 adjacent fingers of non-dominant hand one time
16292268|NCT00700518|Drug|Glyceryl Trinitrate|0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
16292269|NCT00700518|Drug|Glyceryl Trinitrate|1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
16292270|NCT00700518|Drug|Glyceryl Trinitrate|1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
16292271|NCT00700518|Drug|Glyceryl Trinitrate|2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
16292272|NCT00700505|Device|FlowPants(R) Garment|"The garment is shaped like a pair of boxer briefs. Garment heating is battery-powered.
~The garment is activated and begins to heat up 5-15 minutes prior to voiding."
16292273|NCT00700492|Drug|progesterone|vaginal capsules 3X200mg daily
16292274|NCT00700479|Drug|aldosterone|4 hour infusion
16292275|NCT00700479|Dietary Supplement|low or high sodium diet|
16292276|NCT00700479|Drug|placebo|placebo
16292277|NCT00700466|Drug|i.v. beta-blocker infusion (metoprolol)|A beta-blocker (metoprolol) will be infused for treatment of hypertension and/or tachycardia prior to induction of anesthesia aiming at decrease of blood pressure and heart rate to normal limits
16292278|NCT00700453|Behavioral|Control group with no video game play|Subjects will abstain from all video game play during study participation.
16292279|NCT00700453|Behavioral|control 2|Subjects will play 1 week of violent video game play followed by 1 week of no video game play.
16292280|NCT00700453|Behavioral|VG1 group (2 weeks of violent video game play)|Subjects will play a violent video game for 2 weeks of study participation.
16292281|NCT00700453|Behavioral|Cognitive Training|Subjects will play a violent video game for 1 week followed by 1 week of Cognitive Training program.
16292282|NCT00700440|Drug|C225 (cetuximab)|one week before and then weekly during radiotherapy
16292283|NCT00700427|Drug|atomoxetine hydrochloride|Oral 40-100 mg/day
16292284|NCT00700427|Drug|Placebo|Oral delivery of matching placebo
16292285|NCT00700401|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms/week sc for 24 weeks
16292286|NCT00700401|Drug|ribavirin [Copegus]|800mg po daily for 24 weeks
16292287|NCT00700388|Device|TPEP device (UNIKO)|This technique is mainly based on a continuous low-pressure insufflation in the airways, which is likely to reduce (or even avoid) the potential pressure-related damages of other commonly used devices. This device should be used only in those individuals who are showing a normal competence of their cough reflex, thus it should be considered as a means which may help those techniques normally adopted for the individual's bronchial hygiene.
16292288|NCT00700388|Procedure|MABT (Manually assisted breathing techniques)|Conventionally manually assisted breathing techniques
16292289|NCT00700375|Drug|Sodium bicarbonate|8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
16292290|NCT00700375|Drug|Sodium Chloride|8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
16292367|NCT00699894|Drug|aprepitant 40 mg|aprepitant 40 mg PO 1-3 hours prior to surgery
16292368|NCT00699894|Drug|ondansetron 4 mg|ondansetron 4 mg IV 2-5 minutes prior to induction of anesthesia
16292291|NCT00700362|Procedure|Insulin infusion (aspart)|The insulin infusion, a fast acting insulin analog (aspart) in 1 Unit/ml of NaCl, starts when the patients full fill the eligibility criteria and has signed the informed consent. The intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
16292292|NCT00700362|Procedure|Standard care|Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.
16292293|NCT00700349|Other|Small loan|Applicants in the treatment group were offered an interest rate, loan size, and maturity per the lender's standard underwriting criteria, involving a 4-month maturity at 11.75% per month, charged on the original balance (200% annual percentage rate).
16292294|NCT00700336|Drug|pemetrexed, cisplatin and CBP501|"CBP501 25 mg/m2, Pemetrexed 500 mg/m2, cisplatin 75 mg/m2 CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
~Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
16292295|NCT00700336|Drug|pemetrexed and cisplatin|"Pemetrexed 500 mg/m2, cisplatin 75 mg/m2 Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
16292296|NCT00700336|Drug|pemetrexed, cisplatin and CBP501, dose finding|"Dose level 1: CBP501 16 mg/m2, Pemetrexed 500 mg/m2, cisplatin 75 mg/m2 Dose level 2: CBP501 25 mg/m2, Pemetrexed 500 mg/m2, cisplatin 75 mg/m2 CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
~Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
~Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration."
16292297|NCT00700323|Dietary Supplement|PS-Omega3 conjugate supplementation|
16292298|NCT00700323|Dietary Supplement|placebo|
16292299|NCT00700310|Drug|perampanel|2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292300|NCT00700310|Drug|perampanel|4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292301|NCT00700310|Drug|perampanel|8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292302|NCT00700310|Drug|Placebo|Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.
16292303|NCT00700297|Drug|Colchicine|100 mg Colchicine per day for 4 months
16292304|NCT00700297|Drug|Placebo|One tablet placebo per day for 4 months
16292305|NCT00700284|Drug|placebo vaginal ring|vaginal ring containing no TMC120 (dapivirine)
16292306|NCT00700284|Drug|TMC120 (dapivirine) vaginal ring|vaginal ring containing 120 mg TMC120 (dapivirine)
16292307|NCT00700271|Drug|Amlodipine|5 mg or 10 mg tablets.
16292308|NCT00700271|Drug|Valsartan|160 mg capsules.
16292309|NCT00700258|Drug|Temsirolimus|Non-interventional study. Treatment decision already made before inclusion into the registry.
16292310|NCT00700258|Drug|Temsirolimus|Non-interventional study. Treatment decision already made before inclusion into the registry.
16292311|NCT00700258|Drug|Sunitinib|Non-interventional study. Treatment decision already made before inclusion into the registry.
16292312|NCT00700258|Drug|Sunitinib|Non-interventional study. Treatment decision already made before inclusion into the registry.
16292313|NCT00700258|Drug|Axitinib|Non-interventional study. Treatment decision already made before inclusion into the registry.
16292314|NCT00700245|Behavioral|Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)|The exercise intervention for subjects in the EXO consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session. The subjects could choose between different modes of exercise; stationary bicycling, jogging on a treadmill or stair stepping.
16292315|NCT00700245|Behavioral|Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet|Subjects in the DIO group were prescribed a liquid VLED(Nupo, Copenhagen) of respectively 600 and 800 kcal pr. day (proteins 41 g, carbohydrates 29 g, fat 5.6 g. pr 100 gram) for eight weeks followed by a weight maintenance diet for four weeks.
16292316|NCT00700245|Behavioral|Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).|The exercise intervention for subjects in the DEX group consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session
16292317|NCT00700206|Drug|Ezatiostat Hydrochloride|"Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle.
~Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle."
16292318|NCT00700193|Biological|Influenza Virus Vaccine|2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
16292319|NCT00700193|Biological|Influenza Virus Vaccine|2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
16292320|NCT00700180|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3 week cycle
16292321|NCT00700180|Drug|bevacizumab [Avastin]|15mg/kg iv on day 1 of each 3 week cycle
16292322|NCT00700180|Drug|Carboplatin-based chemotherapy|As prescribed
16292468|NCT00699049|Drug|solifenacin|oral
16292323|NCT00700167|Biological|dendritic cell vaccine|"The vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional booster doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months."
16292324|NCT00700154|Procedure|Insulin infusion|The infusion, a fast acting insulin analog in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
16292325|NCT00700128|Drug|frovatriptan|Frovatriptan 2.5 mg or placebo given Bid starting on the last day of OC before taking the 4 day HFI. They will take a total of 10 pills max per HFI.
16292326|NCT00700128|Drug|frovatriptan|frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.
16292327|NCT00700128|Drug|placebo|placebo
16292328|NCT00700115|Drug|Kaletra + Isentress|Kaletra 400/100 mg + Isentress 400 mg BID
16292329|NCT00700115|Drug|Pre-study antiretroviral regimen|Standard doses of pre-study antiretroviral regimen
16292330|NCT00700102|Drug|Chemotherapy|As prescribed
16292331|NCT00700102|Drug|Bevacizumab|Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
16292332|NCT00700089|Behavioral|Assertive intervention|8-20 assertive contacts after suicide attempt
16292333|NCT00700089|Other|Standard treatment|In standard treatment there is no procedure for ensuring that the patient will actually receive the recommended treatment. Patients are often referred to available treatment modalities such as general practitioner, psychological treatment, treatment for alcohol abuse, and most often, the patients are themselves responsible for getting into contact with the treatment to which they are referred.
16292334|NCT00700076|Drug|Ketamine and Org 25935|Oral administration of Org 25935 16 mg and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)
16292335|NCT00700076|Drug|Placebo and Ketamine|Oral administration of placebo and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)
16292336|NCT00700063|Drug|PEP005 Topical Gel|0.005%, two days treatment
16292337|NCT00700063|Drug|PEP005 Topical Gel|0.01%, two days treatment
16292338|NCT00700063|Drug|PEP005 Topical Gel|0.015%, two days treatment
16292339|NCT00700063|Drug|Vehicle gel|two days treatment
16292340|NCT00700063|Drug|PEP005 Topical Gel|0.005%, three days treatment
16292341|NCT00700063|Drug|PEP005 Topical Gel|0.01%, three days treatment
16292342|NCT00700063|Drug|PEP005 Topical Gel|0.015%, three days treatment
16292343|NCT00700063|Drug|Vehicle gel|three days treatment
16292344|NCT00700050|Drug|Hypertonic saline|Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.
16292345|NCT00700050|Drug|Hypertonic saline|Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.
16292346|NCT00700050|Drug|Hypertonic saline|Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.
16292347|NCT00700050|Drug|Hypertonic saline|Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.
16292348|NCT00700037|Drug|high-dose atorvastatin|20mg/day
16292349|NCT00700037|Drug|low-dose atorvastatin|5mg/day
16292350|NCT00700024|Drug|Testim|50 mg/dose7day
16292351|NCT00700024|Behavioral|Strength training|three times a week
16292352|NCT00700024|Drug|placebo|placebo
16292353|NCT00700011|Drug|Clofarabine|10 mg/m2 x 5 days per 4 to 6 week cycles
16292354|NCT00700011|Drug|Clofarabine|5 mg/m2 x 5 days per 4 to 6 week cycles
16292355|NCT00699998|Drug|Clopidogrel|300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
16292356|NCT00699998|Drug|Prasugrel|30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
16292357|NCT00699998|Drug|Commercially-available Aspirin|Low-dose aspirin, oral, as prescribed by physician through end of study
16292358|NCT00699972|Drug|E2007 (perampanel)|8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292359|NCT00699972|Drug|E2007 (perampanel)|12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292360|NCT00699972|Drug|Placebo|Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
16292361|NCT00699946|Drug|olanzapine|5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
16292362|NCT00699946|Drug|placebo|placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor
16292363|NCT00699933|Other|CT-guided percutaneous drainage technique|Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome
16292364|NCT00699920|Drug|Coarsucam|Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days
16292365|NCT00699920|Drug|Coartem|Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
16292366|NCT00699907|Drug|flutamide|Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
16292369|NCT00699881|Drug|cetuximab|cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
16292370|NCT00699868|Other|Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings|Sampling of blood
16292371|NCT00699868|Other|Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings|Sampling of blood
16292372|NCT00699842|Drug|Lenalidomide|"Dose Level Lenalidomide Schedule
~15mg/day for d1-21 out of 28 days
~20mg/day for d1-21 out of 28 days
~25mg/day for d1-21 out of 28 days"
16292373|NCT00699816|Biological|Immuncell-LC|Activated T lymphocyte
16292374|NCT00699803|Drug|T-PRED|T-PRED sterile ophthalmic solution
16292375|NCT00699803|Drug|Pred Forte|Pred Forte sterile ophthalmic solution
16292376|NCT00699790|Drug|CCR2 Antagonist|Tablets, Oral, 50 mg, once daily, 12 weeks
16292377|NCT00699790|Drug|Placebo|Tablets, Oral, 0mg, once daily, 12 weeks
16292378|NCT00699777|Drug|Risedronate|1 risedronate 150 mg tablet administered orally
16292379|NCT00699777|Drug|Risedronate|2 risedronate 75 mg tablets administered as a single oral dose
16292380|NCT00699764|Biological|Herpes simplex candidate vaccine- adjuvanted GSK208141|Intramuscular injection, 3 doses
16292381|NCT00699764|Biological|Placebo injection|Intramuscular injection, 3 doses
16292382|NCT00699751|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
16292383|NCT00699751|Drug|Placebo|Isotonic saline 6 IV administrations separated by 4 weeks intervals.
16292384|NCT00699751|Drug|Best standard of care (BSoC)|Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.
16292385|NCT00699738|Behavioral|Breastfeeding|Breastfeeding
16292386|NCT00699738|Behavioral|Bottlefeeding|Bottlefeeding
16292387|NCT00699712|Drug|CD-NP (Chimeric natriuretic peptide)|Infusion of CDNP at two of four doses
16292388|NCT00699686|Drug|Glargine|Daily bedtime subcutaneous insulin Glargine in individualized doses.
16292389|NCT00699686|Drug|Detemir|Daily bedtime subcutaneous insulin Detemir in individualized doses.
16292390|NCT00699660|Behavioral|CAPS/WHODAS|CAPS/WHODAS structured clinical PTSD interview
16292391|NCT00699660|Behavioral|Nonstructured Interview|Usual PTSD clinical PTSD interview, not CAPS or SCID
16292392|NCT00699634|Drug|Nabilone|Nabilone 0.5 mg at hs for 1 week, then 0.5 mg BID for 1 week. After a reassessment of the outcome measures, the dose is increased to 0.5 mg in the morning and 1 mg at hs for 1 week, followed by an increase to 1 mg BID in the last week of the study.
16292393|NCT00699621|Biological|platelets|Four units of fresh platelets will be infused immediately
16292394|NCT00699608|Drug|GSK1755165; placebo; zopiclone|Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone
16292395|NCT00699582|Drug|E2007 (perampanel)|8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292396|NCT00699582|Drug|E2007 (perampanel)|12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
16292397|NCT00699582|Drug|Placebo|Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
16292398|NCT00699569|Dietary Supplement|hyperimmune colostrum|hyperimmune colostrum
16292399|NCT00699569|Dietary Supplement|Placebo|
16292400|NCT00699556|Drug|21mg transdermal nicotine patch (Nicoderm CQ)|21mg transdermal nicotine patch
16292401|NCT00699556|Drug|1mg nicotine nasal spray|two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.
16292402|NCT00699556|Drug|placebo nasal spray|saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
16292403|NCT00699543|Device|Coroflex Please stent implantation|Use Coroflex Please stent in the treatment of coronary stenosis
16292404|NCT00699543|Device|Taxus stent implantation|Use Taxus stent in the treatment of coronary stenosis
16292405|NCT00699530|Other|Cabergoline|Cabergoline 0,25 - 1,0 mg once a week, controlled by our outpatient clinic. The drug regimen is not influenced by participating in this study.
16292406|NCT00699517|Drug|OMBRABULIN (AVE8062)|I.V. infusion followed by administration of cisplatin
16292407|NCT00699517|Drug|Placebo|I.V. infusion followed by administration of cisplatin
16292408|NCT00699504|Drug|cangrelor|IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs
16292409|NCT00699504|Drug|cangrelor|30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule
16292410|NCT00699504|Drug|cangrelor|60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule
16292411|NCT00699504|Drug|moxifloxacin|400 mg orally. Placebo IV bolus and infusion.
16292412|NCT00699504|Drug|placebo|placebo IV and oral
16292413|NCT00699491|Biological|Cixutumumab|Given IV
16292414|NCT00699491|Other|Laboratory Biomarker Analysis|Correlative studies
16292415|NCT00699491|Other|Pharmacological Study|Correlative studies
16292416|NCT00699491|Drug|Temsirolimus|Given IV
16292417|NCT00699478|Drug|mecobalamin|Methycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months
16292418|NCT00699465|Drug|enoxaparin|20 mg enoxaparin (2 000 IU) s.c. will be given twice daily starting 24-48 h after onset of the stroke. Intermittent pneumatic compression will be started immediately after admission.
16292419|NCT00699465|Drug|enoxaparin placebo|Placebo will be given s.c. twice daily starting 24-48 h after onset of the stroke for 2 days. Thereafter, 20 mg enoxaparin (2 000 IU) s.c. will be given twice daily. Intermittent pneumatic compression will be started immediately after admission.
16292420|NCT00699452|Drug|candesartan|Candesartan 8 mg/d for two weeks, then 16 mg/d until valve replacement surgery (approximately 3 months)
16292421|NCT00699452|Drug|placebo|placebo
16292422|NCT00699439|Other|Paper-based asthma flow diagram|If a patient is identified as having an asthma exacerbation by the Bayesian Network, the patients will be randomized to either arm A or B. If in A, the paper-based flow-chart will be printed out to place on the chart.
16292423|NCT00699426|Drug|nexium|40 mg once daily is tested together with Yoghurt
16292424|NCT00699426|Drug|nexium|nexium and placebo are tested
16292425|NCT00699426|Dietary Supplement|Yoghurt|Yoghurt
16292426|NCT00699426|Drug|placebo+placebo|placebo and placebo are tested.
16292427|NCT00699413|Drug|nutrition education plus active supplement|"After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes.
~Active and inactive supplements will be identical in appearance and taste. Active supplements will contain 2,700 mgs/day of Super CitriMax (hydroxycitrate)and 400 µg per day of ChromeMate (niacin-bound Chromium). Supplements will be in powder and tablet form, and should be taken 30 minutes prior to each meal."
16292428|NCT00699413|Drug|nutrition education plus inactive supplement|"After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes.
~Active and inactive supplements will be identical in appearance and taste."
16292429|NCT00699387|Drug|Benznidazole|benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
16292430|NCT00699374|Drug|sunitinib malate|sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
16292431|NCT00699374|Drug|sorafenib|sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
16292432|NCT00699361|Drug|Pantoprazole|Pantoprazole 160 mg I.V.
16292433|NCT00699361|Drug|Pantoprazole|Pantoprazole 160 mg intravenously (IV)
16292434|NCT00699348|Drug|Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)|Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
16292435|NCT00699335|Drug|Fentanyl|Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs
16292436|NCT00699322|Drug|Sitagliptin|100mg P.O. per day for 1month
16292437|NCT00699322|Drug|Glimepiride|2mg P.O. per day for 1 month
16292438|NCT00699296|Drug|Panobinostat (LBH589)|20mg/day p.o. on three times-a- week
16292439|NCT00699283|Drug|Brivaracetam|25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
16292440|NCT00699283|Drug|Brivaracetam|25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
16292441|NCT00699244|Procedure|Peripheral placement of local anesthesia|Peripheral placement of local anesthesia
16292442|NCT00699244|Procedure|Central placement of local anesthesia|Central placement of local anesthesia
16292443|NCT00699231|Biological|HBV-MPL vaccine 208129|IM injection
16292444|NCT00699231|Biological|Engerix™-B|IM injection
16292445|NCT00699218|Device|Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.|High frequency repetitive TMS given daily on weekdays for 3 weeks
16292446|NCT00699192|Drug|Amlodipine 5 mg|1 capsule amlodipine 5 mg orally once daily
16292447|NCT00699192|Drug|Valsartan 80 mg|1 capsule valsartan 80 mg orally once daily
16292448|NCT00699192|Drug|Valsartan 40 mg|1 capsule valsartan 40 mg orally once daily
16292449|NCT00699192|Drug|Placebo|1 capsule placebo to match valsartan orally once daily
16292450|NCT00699179|Drug|biphasic insulin aspart 30|There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.
16292451|NCT00699166|Drug|DNK333|25 mg and 100 mg oral doses, each taken twice daily
16292452|NCT00699153|Drug|Loteprednol Etabonate|Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
16292453|NCT00699153|Drug|Vehicle of Ophthalmic Loteprednol Etabonate|Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.
16292454|NCT00699140|Biological|IGIV3I Grifols|Immune Globulin Intravenous (Human)
16292455|NCT00699127|Behavioral|Lecture|Lecture of information regarding prematurity, NICU hospitalization, etc.
16292456|NCT00699114|Drug|Placebo|Lactose as powder in gelatine capsules, single dose
16292457|NCT00699114|Drug|Ibuprofen 400 mg|Ibuprofen 400 mg as powder in gelatine capsules, single dose
16292458|NCT00699114|Drug|Ibuprofen 600 mg|Ibuprofen 600 mg as powder in gelatine capsules, single dose
16292459|NCT00699114|Drug|Ibuprofen 800 mg|Ibuprofen 800 mg as powder in gelatine capsules, single dose
16292460|NCT00699114|Drug|Paracetamol (acetaminophen) 500 mg|Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
16292461|NCT00699114|Drug|Paracetamol (acetaminophen) 1000 mg|Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
16292462|NCT00699114|Drug|Paracetamol (acetaminophen) 1000 mg + codeine 60 mg|Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
16292463|NCT00699101|Device|Conture Multi-Lumen Balloon|Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.
16292464|NCT00699062|Drug|singular|The participants randomized into this arm will receive singular 10mg q.n. plus combine therapy with inhaled ICS+LABA
16292465|NCT00699062|Drug|placebo|The participants allocated into this arm will receive placebo 10mg,q.n plus combine therapy with inhaled ICS+LABA
16292466|NCT00699049|Drug|Alpha blocker|oral
16292467|NCT00699049|Drug|placebo|oral
16292469|NCT00699036|Drug|avandia|4 mg twice daily
16292470|NCT00699036|Drug|metformin|500 mg twice daily for 48 weeks
16292471|NCT00699036|Drug|losartan|losartan 50 mg once daily
16292472|NCT00699023|Drug|ezetimibe tablets|ezetimibe tablets 10 mg/die
16292473|NCT00699023|Drug|simvastatin tablets|simvastatin tablets 20 mg/die
16292474|NCT00699023|Drug|placebo|placebo
16292475|NCT00699010|Drug|Acurox 5/30mg taken first|followed by oxycodone 5mg with 48 hour washout
16292476|NCT00699010|Drug|Oxycodone 5mg taken first|followed by Acurox 5/30mg with 48 hour washout
16292477|NCT00698997|Behavioral|Early Start Denver Model|"Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play.
~Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week."
16292478|NCT00698997|Behavioral|Standard community care|Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
16292479|NCT00698984|Dietary Supplement|BONISTEIN(R) bone blend|2 Capsules per day over a period of 6 months
16292480|NCT00698984|Dietary Supplement|Placebo|2 capsules per day over a period of 6 months
16292481|NCT00698958|Procedure|Ambulatory adaptation to non- invasive mechanical ventilation for 7 days|Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
16292482|NCT00698958|Procedure|Hospital based adaptation to non- invasive mechanical ventilation for 7 days|Hospital based adaptation to non- invasive mechanical ventilation for 7 days
16292483|NCT00698945|Drug|Istalol and Optive|Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
16292484|NCT00698945|Drug|Alphagan|Alphagan: two drops a day for 28 days
16292485|NCT00698932|Drug|Saxagliptin|5mg, oral tablet, once daily for 24 weeks
16292486|NCT00698932|Drug|Placebo|oral tablet, once daily for 24 weeks
16292487|NCT00698919|Other|Observational study|"This is not an interventional studies. We will just compare two methods of bacterial diagnosis. Of note the physicians will care of their patients with the classic bacterial analysis tools; so there is no modification of the care.
~The new techniques used (DNA detection) will done later on and thus won't modify their decision."
16292488|NCT00698906|Biological|HBV-MPL vaccine|5 different formulations, 2-dose intramuscular injection
16292489|NCT00698906|Biological|Engerix™-B|3-dose intramuscular injection
16292490|NCT00698893|Biological|Herpes simplex candidate (gD) vaccine GSK208141|Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
16292491|NCT00698880|Procedure|Right hepatic vein embolization|Embolization of the right hepatic vein
16292492|NCT00698854|Device|Vanguard™ Complete Knee System|Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
16292493|NCT00698854|Device|Vanguard™ Patient-Specific Femur|Primary Total Knee System used with Signature technique to provide a patient-specific femur
16292494|NCT00698841|Drug|Cetuximab|Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
16292495|NCT00698828|Drug|Placebo comparator|Twice daily subcutaneous injections of placebo for 12 weeks.
16292496|NCT00698828|Drug|SUN11031 20 μg/kg|Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.
16292497|NCT00698828|Drug|SUN11031 40 μg/kg|Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.
16292498|NCT00698815|Other|Laboratory Biomarker Analysis|Correlative studies
16292499|NCT00698815|Drug|Pemetrexed Disodium|Given IV
16292500|NCT00698815|Drug|Sunitinib Malate|Given PO
16292501|NCT00698802|Drug|EX1000|Treat-to-target titration scheme, s.c. injection
16292502|NCT00698802|Drug|biphasic human insulin|Treat-to-target titration scheme, s.c. injection
16292503|NCT00698789|Drug|INCB019602|5 mg of INCB019602 in AM with placebo administration in PM
16292504|NCT00698789|Drug|INCB019602|20 mg in AM with placebo administration in PM
16292505|NCT00698789|Drug|INCB019602|5 mg in PM with placebo administration in AM
16292506|NCT00698789|Drug|INCB019602|20 mg in PM with placebo administration in AM
16292507|NCT00698789|Drug|INCB019602|7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
16292508|NCT00698789|Drug|Placebo|Placebo administration in AM or PM depending on treatment arm dosing regimen.
16292509|NCT00698789|Drug|Metformin|Stable dose metformin monotherapy
16292510|NCT00698776|Drug|Lenalidomide|10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.
16292511|NCT00698776|Biological|Monocyte derived DCs loaded with KRN7000|10 million DCs injected intravenously
16292512|NCT00698763|Drug|Levosimendan|from 0.125 mg to 2 mg in escalating doses
16292513|NCT00698763|Drug|Placebo|Placebo capsules are identical in appearance to active capsules
16292514|NCT00698724|Drug|Xibrom, and Optive|Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
16292515|NCT00698724|Drug|Xibrom and Pred Forte|Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.
16292552|NCT00698425|Drug|Citrate buffer|Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
16292553|NCT00698412|Device|Cane|This group use the cane every day since the baseline
16292588|NCT00698087|Biological|MPL-Adjuvanted recombinant hepatitis B vaccine|Intramuscular injection, 2 or 3 doses, 2 different formulations
16292589|NCT00698087|Biological|Engerix™-B|Intramuscular injection, 2 or 3 doses
16292516|NCT00698711|Biological|MUC-2-KLH|"The MUC-2-KLH conjugate will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4 week break and then a fourth vaccination during week 7, and 3 months later during week 19. Booster vaccinations may be given at or after week 50 and 100, and every 6 months thereafter to select patients who show no evidence of radiographic disease progression.
~After 5 patients have been enrolled and completed two vaccinations without Grade II or greater toxicity, we will proceed to the next higher dose level. No dose escalations will be performed in the same patient."
16292517|NCT00698685|Drug|Pentostatin|Days - 8 through -6: pentostatin 4 mg/m2/24 hr as a continuous intravenous infusion (CIVI) (total cumulative dose, 12 mg/m2 over 3 days)
16292518|NCT00698685|Biological|Alemtuzumab|Days - 5 through - 1: alemtuzumab 20 mg per dose intravenously over 8 hours daily for 5 doses (total cumulative dose, 100 mg)
16292519|NCT00698685|Procedure|Allogeneic hematopoietic stem cell transplantation|Infusion of related or unrelated donor peripheral blood progenitor cells on day 0.
16292520|NCT00698672|Device|charnley OGEE|charnley OGEE
16292521|NCT00698672|Device|Spectron Reflection CoCr|Spectron Reflection CoCr
16292522|NCT00698672|Device|Spectron XLPE CoCr|Spectron XLPE CoCr
16292523|NCT00698672|Device|Spectron Reflection Oxinium|Spectron Reflection Oxinium
16292524|NCT00698672|Device|Spectron XLPE CoCR|Spectron XLPE CoCR
16292525|NCT00698646|Drug|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
16292526|NCT00698646|Drug|Valsartan|At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
16292527|NCT00698646|Drug|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
16292528|NCT00698607|Device|Everolimus-eluting stent (Xience or Promus)|Use everolimus-eluting stent in the treatment of coronary stenosis
16292529|NCT00698607|Device|Sirolimus-eluting stent (Cypher)|Use sirolimus-eluting stent in the treatment of coronary stenosis
16292530|NCT00698607|Drug|6-month clopidogrel therapy|Use clopidogrel for 6 months
16292531|NCT00698607|Drug|12-month clopidogrel therapy|Use clopidogrel for 12 months
16292532|NCT00698594|Biological|sublingual allergen extract|Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group
16292533|NCT00698594|Biological|sublingual allergen extract|Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group
16292534|NCT00698594|Biological|placebo|Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group
16292535|NCT00698581|Drug|Brivaracetam|25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
16292536|NCT00698581|Drug|Brivaracetam|25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
16292537|NCT00698568|Biological|Herpes simplex candidate vaccine- adjuvanted GSK 208141|Intramuscular injection, 3 doses
16292538|NCT00698568|Biological|Placebo|Intramuscular injection, 3 doses
16292539|NCT00698555|Biological|HBV-MPL vaccine|5 different formulations, 2-dose intramuscular injection
16292540|NCT00698555|Biological|Engerix™-B|3-dose intramuscular injection
16292541|NCT00698529|Behavioral|Face-to-face training|NGOs will receive the POL intervention through face-to-face training. Staff will receive 2-day training on the POL intervention and individualized telephone follow-up consultations concerning POL implementation.
16292542|NCT00698529|Behavioral|Distance training|NGOs will receive the POL intervention through Web-based training. Staff will receive training delivered entirely by means of a Web-based, distance learning curriculum and through individualized telephone follow-up consultations concerning POL implementation.
16292543|NCT00698529|Behavioral|Popular Opinion Leader (POL)|POL is a community-level HIV intervention that recruits and trains opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers.
16292544|NCT00698516|Drug|Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)|2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.
16292545|NCT00698490|Biological|Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141|Intramuscular injection, 3 doses, 2 different formulations
16292546|NCT00698490|Biological|Herpes simplex virus containing gD-Alum|Intramuscular injection, 3 doses
16292547|NCT00698464|Drug|Pasireotide|Single subcutaneous injection of 600 µg of Pasireotide.
16292548|NCT00698451|Drug|doxorubicin HCL liposome; bevacizumab; carboplatin|30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
16292549|NCT00698438|Device|Ex-PRESS implantation|"I. Mobility check of the device. II. Administration of a local or topical anesthetic. III. Preparation and coverage of the eye by conventional sterile procedures. IV. Injection of viscoelastic material into the AC through a paracenthesis. V. Creation of a scleral tunnel up to clear cornea. VI. Creation of a (5 mm) conjunctival tunnel fornix based. VII. Lifting of the conjunctiva and tenon. VIII. Formation of a 2mm scleral incision at 0.3mm depth, 1.5mm from the limbus. IX. Application of 0.5µg/ml MMC under the tunnel for one minute.
~X. Penetration into the AC using a 0.65mm stiletto, inside the tunnel of the sclera-corneal junction.
~XI. Implantation of the Ex-PRESSTM through that pre-incision at the sclerocorneal junction.
~XII. Introducer withdrawal. XIII. Tucking the plate under the scleral tunnel, and verification of the position inside the tunnel.
~XIV. Reposition the conjunctiva with 1 - 2 sutures at the limbus. XV. Closing the conjunctiva with a suture."
16292550|NCT00698438|Procedure|Trabeculectomy|standard trabeculectomy
16292551|NCT00698425|Other|EyeGate II® Drug Delivery System|Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
16292812|NCT00696657|Drug|placebo|1.6 mg, once weekly, s.c. injection
16292554|NCT00698386|Dietary Supplement|Zinc supplement|Zinc miconutrient supplements have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.Each micronutrient capsule contains 50mg zinc (as zinc sulphate) in a lactose matrix.In this clinical trial one tablet of zinc as oral supplement will be given everyday during the entire course in line with the directly observed treatment, short-course (DOTS) strategy recommended by the World Health Organization.
16292555|NCT00698386|Dietary Supplement|Placebo|Placebo have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.The placebo consisted of lactose alone. Supplement and placebo capsules were indistinguishable in appearance both externally and internally.
16292556|NCT00698347|Device|M2a-Magnum™ Hip System|
16292557|NCT00698334|Drug|INH, Rifampicin, Ethambutol and Pyrazinamide|Directly Observed Treatment Short-course; Thrice weekly (INH 600 mg, Rifampicin 450 mg [600 mg if more than 59 kg], Ethambutol 1200 mg, Pyrazinamide 1500 mg)
16292558|NCT00698334|Drug|INH, Rifampicin, Ethambutol and Pyrazinamide|Directly Observed Treatment Short-course; Thrice weekly (INH 600 mg, Rifampicin 450 mg [600 mg if more than 59 kg], Ethambutol 1200 mg, Pyrazinamide 1500 mg)
16292559|NCT00698321|Behavioral|HIV/STD prevention curriculum|The curriculum will include eight 1-hour HIV prevention modules administered weekly for 8 weeks. The modules will educate youth about risky sexual behaviors and will provide them with knowledge and skills necessary to reduce their risk of STDs, HIV, and pregnancy by abstaining from sex or using condoms if they choose to have sex. The curriculum is based on cognitive behavioral theories, focus groups, and the researchers' experience working with youth.
16292560|NCT00698321|Behavioral|General health promotion curriculum|The curriculum will include eight 1-hour general health modules administered weekly for 8 weeks. The curriculum will focus on teaching students healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance abuse.
16292561|NCT00698282|Drug|AZD1981|Oral tablet, 250 mg single dose
16292562|NCT00698282|Drug|AZD1981|Suspension, 15, 75, 1000 and 2000 mg
16292563|NCT00698282|Drug|Placebo|
16292564|NCT00698269|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16292565|NCT00698269|Drug|biphasic insulin aspart 30|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16292566|NCT00698269|Drug|insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16292567|NCT00698256|Dietary Supplement|vegetable oil-based spread and oat-based drink (no brand name available)|spread and drink (9 g stanols/d)
16292568|NCT00698256|Dietary Supplement|vegetable oil-based spread and oat-based drink (no brand name available)|Spread and drink (not containing added stanols)
16292569|NCT00698243|Drug|OSI-027|Administered orally
16292570|NCT00698230|Drug|INCB013739|INCB013739 5 mg QD tablet
16292571|NCT00698230|Drug|INCB013739|INCB013739 15 mg QD tablet
16292572|NCT00698230|Drug|INCB013739|INCB013739 50 mg QD tablet
16292573|NCT00698230|Drug|INCB013739|INCB013739 100 mg QD tablet
16292574|NCT00698230|Drug|INCB013739|INCB013739 200 mg QD
16292575|NCT00698230|Drug|Placebo comparator matching INCB013739|Orally once daily tablet
16292576|NCT00698230|Drug|Metformin|
16292577|NCT00698204|Drug|celecoxib|Subject was asked to take celecoxib each day that radiation therapy was given.
16292578|NCT00698204|Drug|placebo|Subject was asked to take placebo each day that radiation therapy was given.
16292579|NCT00698191|Biological|Allogeneic MSC (AlloMSC)|"Intervention:
~Cyclophosphamide will be administered intravenously at at total dose of 0.8-1.8g 24 hours before transplantation.
~Allogeneic bone marrow derived mesenchymal stem cells (matched family donors)will be infused intravenously at 106 cells/kg body weight"
16292580|NCT00698178|Other|Anthropometric measurements|All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment
16292581|NCT00698139|Device|Medtronic Pacemaker|Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
16292582|NCT00698126|Drug|soluble human insulin|Observational study; use of the products as in the normal clinical practice conditions
16292583|NCT00698126|Drug|biphasic insulin aspart|Observational study; use of the products as in the normal clinical practice conditions
16292584|NCT00698113|Procedure|Massage|"Children will receive a 10-15 minute massage seated (clothed), or in bed (clothed or unclothed) each day using the following protocol: stroking, effleurage, petrissage, muscle squeezing, effleurage, stroking. Massaged areas can include the back, arms and legs.
~Parents will receive a one hour educational session with a Massage Therapist, a DVD, and written materials that all illustrate the required protocol."
16292585|NCT00698113|Other|Journaling|Children will complete weekly journals about their feelings. These journals will either be drawn or written based on the preference of the child. Parents will complete a weekly journal outlining the number of massages given to their child, barriers that prevented massage, and their experience of giving the massage.
16292586|NCT00698100|Biological|human tyrosinase|Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
16292587|NCT00698100|Biological|mouse tyrosinase|Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
16292590|NCT00698074|Device|Cardiac Resynchronisation Therapy|Biventricular Pacemaker Implant
16292591|NCT00698061|Biological|HBV-MPL vaccine 208129|3-dose primary vaccination and booster vaccination by intramuscular injection
16292592|NCT00698061|Biological|Engerix™-B|3-dose primary vaccination and booster vaccination by intramuscular injection
16292593|NCT00698035|Drug|Testosterone Cream|1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
16292594|NCT00698035|Drug|Estring|2mg ring inserted vaginally once every 12 weeks
16292595|NCT00698022|Drug|risperidone|daily risperidone plus mifepristone for 28 days
16292596|NCT00698022|Drug|risperidone matched placebo|risperidone-matched placebo plus mifepristone daily for 28 days
16292597|NCT00698022|Drug|risperidone-matched placebo|daily risperidone-matched placebo plus mifepristone for 28 days
16292598|NCT00698022|Drug|Mifepristone-matched placebo|daily mifepristone-matched placebo for 28 days
16292599|NCT00698009|Drug|Fludarabine|25 mg/m^2 By Vein Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2.
16292600|NCT00698009|Drug|Cyclophosphamide|60 mg/kg By Vein Daily Over 2 Hours On Days -5 and -4
16292601|NCT00698009|Biological|Natural Killer Cell Infusion|Natural Killer Cell Infusion on Day 0.
16292602|NCT00698009|Drug|Mesna|12 mg/kg By Vein, Over about 15 minutes, Five Times Per Day on Days -5 and -4.
16292603|NCT00698009|Drug|Interleukin-2|"Received under skin three times weekly for 9 total doses following NK Cell Infusion:
~For patients weighing 45 kg or more, dose administered is 10 Million units three times weekly for 9 total doses. For patients less than 45 kg, dose administered is 5 Million units/m2 (max dose 10 Million units) three times weekly for 9 total doses."
16292604|NCT00697996|Drug|Rituximab for transplant rejection|
16292605|NCT00697970|Biological|HBsAg formulated with different concentrations of MPL and Aluminium Salts|Intramuscular injection, 3 doses
16292606|NCT00697970|Biological|Engerix™-B|Intramuscular injection, 3 doses
16292607|NCT00697957|Behavioral|Exercise|Progressive impact exercise
16292608|NCT00697944|Drug|Amphotericine in liposome (Ambisome®)|2 IV infusions separated by one week 10 mg/kg per injection
16292609|NCT00697931|Biological|Recombinant MPL- adjuvanted hepatitis B vaccine|Intramuscular injection, 3 doses
16292610|NCT00697931|Biological|Engerix™-B|Intramuscular injection, 3 doses
16292611|NCT00697918|Drug|RWJ-333369|100 mg to 400 mg twice daily
16292612|NCT00697905|Drug|Gemcitabine|Intravenous administration on days 1, 8 of a 21-day cycle
16292613|NCT00697905|Drug|Carboplatin|Intravenous following Gemcitabine infusion on day 1
16292614|NCT00697905|Drug|Cisplatin|Intravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle
16292615|NCT00697905|Drug|5-fluorouracil (5-FU)|Intravenous infusion on day 2 to day 5
16292616|NCT00697892|Drug|lopinavir/ritonavir|Two tablets of lopinavir 200mg / ritonavir 50mg orally twice daily with food for 26 days
16292617|NCT00697892|Drug|efavirenz|One 600mg tablet orally once daily before bedtime on an empty stomach for 26 days
16292618|NCT00697892|Drug|artemether/lumefantrine|4 tablets of artemether 20mg/lumefantrine 120mg twice daily with food. 2 three-day courses will be administered (with washout in between) during the duration of the trial.
16292619|NCT00697879|Drug|CHR-3996|Once daily oral ingestion of capsules (5, 10, 20 or 40 mg), dose depending on cohort, treatment cycle of 28 days
16292620|NCT00697866|Biological|HBV-MPL vaccine 208129|3 consecutive lots; 3-dose intramuscular injection
16292621|NCT00697866|Biological|Engerix™-B|3-dose intramuscular injection
16292622|NCT00697853|Biological|Engerix™-B|3-dose intramuscular injection
16292623|NCT00697853|Biological|HBV-MPL vaccine 208129|2-dose intramuscular injection
16292624|NCT00697840|Biological|Engerix™-B|Intramuscular injection, 2 doses
16292625|NCT00697840|Biological|HBV-MPL 208129|Intramuscular injection, 2 doses
16292626|NCT00697840|Biological|Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation|Intramuscular injection, 2 doses; experimental formulation
16292627|NCT00697827|Device|Interspinous Spacer device|Device: In-Space
16292628|NCT00697827|Device|Interspinous Process Distraction Device|Device: X STOP
16292629|NCT00697814|Drug|Clomiphene citrate|Clomiphene 50 mg/day for 12 weeks
16292630|NCT00697801|Drug|MAP0010 low dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
16292631|NCT00697801|Drug|MAP0010 high dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
16292632|NCT00697801|Drug|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
16292633|NCT00697788|Drug|Dexmedetomidine|Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
16292634|NCT00697775|Biological|HBV-MPL vaccine Formulation A|Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
16292635|NCT00697775|Biological|HBV-MPL vaccine Formulation B|2-dose intramuscular injection
16292636|NCT00697775|Biological|Engerix™-B|Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
16292637|NCT00697762|Drug|RWJ-333369|200 mg tablet twice daily for 12 weeks
16292638|NCT00697762|Drug|RWJ-333369|100 mg tablet twice daily for 12 weeks
16292639|NCT00697762|Drug|Placebo|Placebo tablet twice daily for 12 weeks
16292640|NCT00697749|Biological|HBV-MPL vaccine 208129|2-dose intramuscular injection
16292641|NCT00697749|Biological|Engerix™-B|3-dose intramuscular injection
16292642|NCT00697736|Procedure|Echocardiography with myocardial tissular Doppler mode|Echocardiography with myocardial tissular Doppler mode during rest and exercise on a table equipped with a cyclo-ergometer
16292643|NCT00697723|Procedure|Transit-time flowmetry|Transit-time flowmetry during 1:1 IABP assistance and when IABP is turned off
16292644|NCT00697710|Drug|50 mg S-777469|S-777469, 50 mg BID
16292645|NCT00697710|Drug|200 mg S-777469|S-777469, 200 mg BID
16292646|NCT00697710|Drug|800 mg S-777469|S-777469, 800 mg BID
16292647|NCT00697710|Drug|Placebo|Matching Placebo
16292648|NCT00697697|Drug|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
16292649|NCT00697697|Drug|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
16292650|NCT00697684|Drug|Antithymocyte Globulin|
16292651|NCT00697684|Drug|Clofarabine|Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 20mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 100 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
16292652|NCT00697684|Drug|Clofarabine|Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 30mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 150 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
16292653|NCT00697684|Drug|Clofarabine|Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 40mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 200 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
16292654|NCT00697671|Other|NK Cell Infusion|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued
16292655|NCT00697671|Biological|Immunotherapy|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292656|NCT00697671|Device|Miltenyi Biotec CliniMACS device|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292657|NCT00697671|Drug|Interleukin-2 (IL-2)|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292658|NCT00697671|Drug|Clofarabine|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292659|NCT00697671|Drug|Cyclophosphamide|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292660|NCT00697671|Drug|Etoposide|All participants will receive a 4 day regimen of chemotherapy (clofarabine, cyclophosphamide, and etoposide) followed by an infusion of HLA partially matched family member donor NK cells processed through the use of the investigational CliniMACS device. Interleukin-2 (IL-2) will be given three times per week post-infusion for a minimum of 2 weeks. IL-2 administration will continue until donor NK cells are no longer detectable in the recipient, and, at that time, will be discontinued.
16292661|NCT00697658|Drug|Paliperidone ER|6 mg tablet once daily, variable treatment length.
16292662|NCT00697645|Device|Deep TMS (Transcranial magnetic stimulation)|All participants will receive standard medical and rehabilitation therapy for stroke without any restrictions. In addition, patients recruited for the study will receive 7 sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for 15 minutes and the brain will be stimulated at 10Hz. Each TMS train will contain 20 pulses (2 seconds) and the inter train interval will be 20 seconds. Each session will contain 40 trains. Sessions will begin on day 3-5 after stroke onset and will be given every day, excluding weekends, for 10 days. All deep TMS will be performed in a dedicated room under the observation of an unblinded investigator. Patients will be monitored daily until discharge from the hospital, or until the end of the treatment, whichever is earlier. All assessments will be performed by investigators blinded to the therapy group.
16292663|NCT00697645|Device|Brainsway Deep TMS|Deep TMS applied over the motor strip
16292664|NCT00697632|Drug|MGCD265|Oral daily administration without interruption
16292665|NCT00697619|Drug|Zometa (zoledronic acid)|Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
16292666|NCT00697606|Device|Seprafilm®|Seprafilm® placed at time of primary cesarean
16292667|NCT00697606|Other|Control|no Seprafilm® used at primary cesarean
16292668|NCT00697593|Drug|Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.
16292669|NCT00697580|Behavioral|Nutrition|Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
16292766|NCT00696878|Drug|Progesterone|Progesterone administered vaginally at a dose of at least 600 mg/day.
16292670|NCT00697580|Behavioral|Strength Training & Nutrition|Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions)
16292671|NCT00697580|Behavioral|Circuit Training & Nutrition|Circuit Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions)
16292672|NCT00697567|Biological|Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant|Intramuscular injection, 3 doses
16292673|NCT00697567|Biological|Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant|Intramuscular injection, 3 doses
16292674|NCT00697554|Biological|HBV-MPL vaccine 208129|2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection
16292675|NCT00697554|Biological|Engerix™-B|3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses
16292676|NCT00697541|Drug|0.18% COL-118 facial gel (1.8 mg brimonidine)|One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours
16292677|NCT00697541|Drug|0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop)|One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically.
16292678|NCT00697541|Drug|Advanced Eye Relief|One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours
16292679|NCT00697541|Drug|COL-118 facial gel vehicle|One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
16292680|NCT00697515|Drug|LDX|oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting
16292681|NCT00697515|Drug|Placebo|Placebo administered once-daily for one week during the adult workplace environment setting
16292682|NCT00697502|Drug|Capecitabine|"Capecitabine (XELODA) is supplied as biconvex, oblong film-coated tablets for oral administration and will be obtained from NUH Cancer Centre pharmacy.
~Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. Capecitabine is to be administered orally within 30 minutes after the end of a meal (breakfast, dinner). Tablets should be swallowed with about 200 mL of water (not fruit juices). Capecitabine will be administered for 14 days followed by a 7 day rest period."
16292683|NCT00697489|Procedure|correction of POP plus preventive continence procedure|
16292684|NCT00697489|Procedure|POP surgery followed by eventual incontinence procedure|
16292685|NCT00697476|Drug|topotecan, vorinostat|"Phase I study: vorinostat will be administered daily for a number of days per cycle variable from 7 to 14 according to the level of dose escalation; topotecan will be administered I.V. for 5 consecutive days every 3 weeks.
~Phase II study: Patients will receive treatment at the recommended dose established by phase I part of the trial, for a maximum of 6 cycles or until disease progression, unacceptable toxicity or patient's refusal."
16292686|NCT00697463|Drug|Teriparatide (PTH 1-34)|20 micrograms subcutaneous injection daily
16292687|NCT00697450|Drug|insulin detemir|Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation
16292688|NCT00697437|Drug|Docetaxel|70mg q3wx 1 dose
16292689|NCT00697437|Drug|Ketoconazole|6 doses of oral ketoconazole 200mg bid starting 2 days before, and with 1 dose to be completed after, docetaxel infusion
16292690|NCT00697424|Device|SleepStyle 200 Auto Series CPAP Humidifier|The device will record on internal software perceived sleep disordered breathing events. Events will also be scored manually on the polysomnography (PSG. Results will then be compared.
16292691|NCT00697398|Other|Transcranial stimulation|Stimulation to white
16292692|NCT00697398|Other|Transcranial stimulation|Repetitive transcranial magnetic stimulation (rTMS)
16292693|NCT00697385|Drug|Cyclokapron|(2) 500mg tablets taken by mouth every 6-8 hours
16292694|NCT00697372|Device|Sirolimus eluting stent|Implantation of Sirolimus eluting stent
16292695|NCT00697372|Device|Everolimus eluting stent|Implantation of Everolimus eluting stent
16292696|NCT00697359|Device|Implantable loop recorder (ILR)|The ILR will be implanted subcutaneous following standard surgical procedure.
16292697|NCT00697346|Drug|Alisertib|Alisertib (MLN8237) PIC or ECT
16292698|NCT00697333|Procedure|restriction of radiotherapy to FDG-PET positive areas only|Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose
16292699|NCT00697320|Drug|eptacog alfa (activated)|"A NON INTERVENTIONAL OBSERVATIONAL STUDY:
~Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation"
16292700|NCT00697294|Dietary Supplement|Tri-Vi-Sol|All subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops.
16292701|NCT00697281|Drug|OC000459|"Tablets twice daily for 8 days
~Dose level 1"
16292702|NCT00697281|Drug|OC000459|"Tablets twice daily for 8 days
~Dose level 2"
16292703|NCT00697281|Drug|OC000459|"Tablets twice daily for 8 days
~Dose level 3"
16292704|NCT00697281|Drug|OC000459|"Tablets twice daily for 8 days
~Dose level 4"
16292705|NCT00697281|Drug|Placebo|"Tablets twice daily for 8 days
~Dose level 5"
16292706|NCT00697255|Drug|corifollitropin alfa|SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).
16292707|NCT00697255|Biological|recombinant Follicle Stimulating Hormone (recFSH)|Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.
16292767|NCT00696865|Drug|AZD2624|oral suspension, 3 doses
16292768|NCT00696865|Drug|Placebo|
16292708|NCT00697255|Biological|human Chorion Gonadotropin (hCG)|Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.
16292709|NCT00697255|Biological|hCG Bolus injection|Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.
16292710|NCT00697242|Biological|Engerix™-B|Intramuscular injection, 3 doses
16292711|NCT00697242|Biological|Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL|Intramuscular injection, 3 doses
16292712|NCT00697229|Biological|Engerix™-B|Intramuscular injection, 1 or 3 doses
16292713|NCT00697229|Biological|HBV-MPL vaccine|Intramuscular injection, 1 or 3 doses
16292714|NCT00697216|Biological|HBV-MPL vaccine 208129|2-dose intramuscular injection
16292715|NCT00697216|Biological|Engerix™-B|3-dose intramuscular injection
16292716|NCT00697203|Drug|Placebo|po daily for 12 weeks
16292717|NCT00697203|Drug|Pravastatin|40mg po daily for 12 weeks
16292718|NCT00697203|Drug|Dalcetrapib|300mg po daily for 12 weeks
16292719|NCT00697203|Drug|Dalcetrapib|600mg po daily for 12 weeks
16292720|NCT00697203|Drug|Dalcetrapib|900mg po daily for 12 weeks
16292721|NCT00697190|Device|senofilcon A toric|silicone hydrogel contact lens for patients with astigmatism
16292722|NCT00697190|Device|galyfilcon A toric|silicone hydrogel contact lens for patients with astigmatism
16292723|NCT00697164|Drug|Placebo|Saline Admission, day 1, day 2 3 days
16292724|NCT00697164|Drug|Erythropoietin|Erythropoietin, 1500 U/kg/day Admission, day 1, day 2 3 days
16292725|NCT00697151|Drug|Warfarin|Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day
16292726|NCT00697151|Drug|Aspirin|Aspirin 325 mg once a day; placebo warfarin once a day
16292727|NCT00697138|Drug|d-Amphetamine; Atomoxetine|Dexedrine (0-60 mg/day); Strattera (0-80 mg/day)
16292728|NCT00697125|Biological|Engerix™-B|Intramuscular injection, 3 doses
16292729|NCT00697125|Biological|HBV-MPL vaccine (208129)|
16292730|NCT00697125|Biological|Hepatitis B vaccine, experimental formulation|Intramuscular injection, 3 doses
16292731|NCT00697112|Drug|Sirolimus|Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.
16292732|NCT00697099|Drug|Semuloparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16292733|NCT00697099|Drug|Enoxaparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16292734|NCT00697099|Drug|Placebo|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component
~Subcutaneous injection"
16292735|NCT00697086|Drug|Dronedarone (SR33589)|
16292736|NCT00697086|Drug|Placebo|
16292738|NCT00697060|Drug|Imexon + docetaxel|Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
16292739|NCT00697047|Behavioral|Automated Mailing|Usual Care plus Automated mailing
16292740|NCT00697047|Behavioral|Automated Mailing Plus Assisted|If not screened after automated mailing, MA assists with screening.
16292741|NCT00697047|Behavioral|Auto Plus Assisted Plus Navigation|If not screened after automated mailing and assistance by MA, RN begins navigation.
16292742|NCT00697034|Drug|Capsaicin|natural alkaloid derived from hot chili peppers and activates vanilloid receptors that are also activated by endogenous cannabinoid anandamide applied three times daily
16292743|NCT00697021|Drug|Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG|Non- responders to Aspirin or Plavix shown on TEG analysis will be treated by doubling of Aspirin (200mg) and/or Plavix (150mg) dosage
16292744|NCT00697021|Drug|Aspirin 100mg and Plavix 75mg|Responders to standard dual antiplatelet therapy as observed by TEG analysis will continue standard doses of Aspirin and Plavix
16292745|NCT00696995|Drug|biphasic insulin aspart 30|Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
16292746|NCT00696982|Drug|sitagliptin|sitagliptin 100 mg once daily for 3 months
16292747|NCT00696982|Drug|glibenclamide|glibenclamide 5 mg once a day titrated as neede up to 20 mg a day
16292748|NCT00696969|Drug|Amphotericin B Deoxycholate|1 mg/kg e.o.d for 30 days
16292749|NCT00696969|Drug|Ambisome + Miltefosine|Ambisome (i.v. single dose 5 mg/kg)+ Miltefosine 7 days
16292750|NCT00696969|Drug|Ambisome and Paromomycin|Ambisome 5 mg/kg single dose + Paromomycin Sulphate 15mg/kg/day for 10 days
16292751|NCT00696969|Drug|Miltefosine and Paromomycin|Miltefosine (standard dose) and Paromomycin Sulphate 15mg/kg/day for 10 days
16292752|NCT00696956|Device|Balloon angioplasty (uncoated conventional balloon)|endovascular therapy
16292753|NCT00696956|Device|Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)|endovascular therapy
16292754|NCT00696943|Drug|([18F]-ML-10)|[18F]-ML-10 was administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The radiation dose of [18F]-ML-10 administered at each session was 300-500 MBq (8.1-13.5 mCi).
16292755|NCT00696930|Drug|90Y-SMT487|
16292756|NCT00696917|Biological|HBV-MPL vaccine 208129|2-dose intramuscular injection 3 different vaccine lots
16292757|NCT00696917|Biological|Engerix™-B|3-dose intramuscular injection
16292758|NCT00696904|Drug|ABT-333|Capsule, see arms for intervention description
16292759|NCT00696904|Drug|Placebo|Capsule, see arms for intervention description
16292760|NCT00696891|Biological|HBV-MPL vaccine|3-dose intramuscular injection
16292761|NCT00696891|Biological|Engerix™-B|3-dose intramuscular injection
16292762|NCT00696878|Drug|Corifollitropin alfa|Corifollitropin alfa 150 µg administered as a single subcutaneous dose.
16292763|NCT00696878|Biological|FSH|FSH administerd subcutaneously at a dose not to exceed 225 IU/day.
16292764|NCT00696878|Biological|GnRH antagonist|GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.
16292765|NCT00696878|Biological|(rec)hCG|(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.
16292769|NCT00696852|Behavioral|Mindfulness Meditation|The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
16292770|NCT00696852|Behavioral|Yoga|The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
16292771|NCT00696852|Behavioral|Exercise, Relaxation, and Health Education|The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include simple relaxation (such as progressive muscle relaxation) and light stretching exercises, group support, and discussions of various health topics and on stress reduction.
16292772|NCT00696839|Behavioral|Cognitive-behavioral therapy|3 sessions of CBT: introduction of CBT, training in relaxation and guided imagery, and troubleshooting/closure. 50 minute sessions with an HIV-experienced treating psychologist in Beck-type CBT. Participants will be given an audiorecording of the 2nd session to be used in private home practice, as desired.
16292773|NCT00696826|Drug|sitagliptin phosphate|sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks
16292774|NCT00696800|Drug|Corifollitropin alfa|On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
16292775|NCT00696800|Biological|RecFSH / Follitropin beta (Days 1 to 7)|Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16292776|NCT00696800|Drug|Placebo Corifollitropin alfa|Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
16292777|NCT00696800|Drug|Placebo RecFSH / follitropin beta|Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
16292778|NCT00696800|Biological|RecFSH / Follitropin beta (Days 8 to hCG)|From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
16292779|NCT00696800|Drug|Ganirelix|On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
16292780|NCT00696800|Biological|hCG|When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
16292781|NCT00696800|Biological|Progesterone|On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
16292782|NCT00696787|Drug|Desvenlafaxine Sustained Release (DVS SR)|
16292783|NCT00696787|Drug|Lyrica® (Pregabalin)|
16292784|NCT00696787|Drug|Placebo|
16292785|NCT00696774|Drug|Duloxetine|"Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.
~Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more."
16292786|NCT00696761|Drug|Alfuzosin|10mg, once daily, 12months
16292787|NCT00696761|Drug|Alfuzosin|10mg, once daily, 12months
16292788|NCT00696761|Drug|Alfuzosin|10mg, once daily, 12months
16292789|NCT00696761|Drug|Alfuzosin|10mg, once daily, 12months
16292790|NCT00696748|Drug|Nebido (testosterone undecanoate)|Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
16292791|NCT00696748|Drug|Placebo|Placebo 4 mL intramuscular
16292792|NCT00696735|Procedure|chemotherapy|injection cyclophosphamide doxorubicin (25 mg/m2), and teniposide (60 mg/m2)(600 mg/m2)on day 1 and prednisone (40 mg/m2), administered orally on days 1 to 5.4,12 Treatment consisted of a 6-course induction phase administered monthly, followed, for responders and patients presenting a stable disease, by a maintenance phase that consisted of 1 cycle every 2 months for 1 year. Concomitant subcutaneous interferon alfa-2b was administered at 5 x 106 3 times a week for 18 months.
16292793|NCT00696735|Procedure|high dose therapy and autologous stem cell transplantation|VCAP regimen 3 cycles , less than PR: 2-3 DHAP, stem cell collection, in vitro purging autologous stem cell transplantation with TBI and cyclophosphamide
16292794|NCT00696722|Drug|placebo + atazanavir|"Placebo treatment first, atazanavir treatment second
~4 day treatment"
16292795|NCT00696722|Drug|atazanavir + placebo|"Atazanavir treatment first, placebo treatment second
~4 day treatment"
16292796|NCT00696709|Biological|Comparator: V212|0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
16292797|NCT00696709|Biological|Comparator: Placebo|Placebo; 4-dose regimen administered ~30 days apart.
16292798|NCT00696696|Drug|Gemcitabine|1000 mg/m^2, intravenous, Days 1, 8, 15 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
16292799|NCT00696696|Drug|Erlotinib|150 mg, taken orally, once a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
16292800|NCT00696696|Drug|Sorafenib|400 mg, taken orally, twice a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
16292801|NCT00696683|Other|None, this is an observational study|
16292802|NCT00696657|Drug|semaglutide|0.1 mg, once weekly, s.c. injection
16292803|NCT00696657|Drug|semaglutide|0.2 mg, once weekly, s.c. injection
16292804|NCT00696657|Drug|semaglutide|0.4 mg, once weekly, s.c. injection
16292805|NCT00696657|Drug|semaglutide|0.8 mg, once weekly, s.c. injection
16292806|NCT00696657|Drug|semaglutide|0.8 mg with titration, once weekly, s.c. injection
16292807|NCT00696657|Drug|semaglutide|1.6 mg with titration, once weekly, s.c. injection
16292808|NCT00696657|Drug|placebo|0.1 mg, once weekly, s.c. injection
16292809|NCT00696657|Drug|placebo|0.2 mg, once weekly, s.c. injection
16292810|NCT00696657|Drug|placebo|0.4 mg, once weekly, s.c. injection
16292811|NCT00696657|Drug|placebo|0.8 mg with titration, once weekly, s.c. injection
16292813|NCT00696657|Drug|liraglutide|1.2 mg with titration, once daily, s.c. injection
16292814|NCT00696657|Drug|liraglutide|1.8 mg with titration, once daily, s.c. injection
16292815|NCT00696644|Drug|Teriparatide|20 mcg daily subcutaneous for 18 months.
16292816|NCT00696631|Drug|Dronedarone (SR33589)|oral administration
16292817|NCT00696631|Drug|Placebo|oral administration
16292818|NCT00696618|Drug|Fleet Enema|hyper-osmolar preparation
16292819|NCT00696618|Drug|tap water enema|hypo-osmolar preparation
16292820|NCT00696618|Drug|Normosol-R enema|iso-osmolar preparation
16292821|NCT00696592|Drug|Bevacizumab (Avastin), Verteporfin (Visudyne)|
16292822|NCT00696579|Drug|BCG|6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
16292823|NCT00696579|Drug|gemcitabine|14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
16292824|NCT00696566|Drug|Clopidogrel and Rifampicin|"Clopidogrel: loading dose of 600 mg, then 75 mg o.d. for up to 28 days
~Rifampicin: 300 mg b.d. for up to 28 days"
16292825|NCT00696553|Other|Tailored Nutrition Intervention|Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
16292826|NCT00696553|Behavioral|Nutrition plus Exercise|Nutrition plus Exercise
16292827|NCT00696540|Drug|Inhalation of salbutamol diluted in hypertonic saline|The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.
16292828|NCT00696540|Drug|Inhalation of salbutamol diluted in normal saline|The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.
16292829|NCT00696514|Dietary Supplement|Vitamin B12, folic acid, Vitamin D3|500 µg vitamin B12; 0.4 mg folic acid; 600 IU vitamin D3 in one capsule, once per day
16292830|NCT00696514|Dietary Supplement|Placebo (Vitamin D3) - 600 IU per day|600 IU vitamin D3 in one capsule, once per day
16292831|NCT00696488|Drug|Fluorouracil 0.5%|Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
16292832|NCT00696475|Drug|Diazoxide choline|
16292833|NCT00696475|Drug|Diazoxide choline|
16292834|NCT00696475|Drug|Diazoxide choline|
16292835|NCT00696475|Drug|Placebo|
16292836|NCT00696462|Device|forced-air warming|forced-air warming device
16292837|NCT00696449|Drug|Adapalene|All Subjects will treat the face once daily in the evening.
16292838|NCT00696449|Behavioral|frequent visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
16292839|NCT00696449|Behavioral|electronic reminder|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
16292840|NCT00696449|Behavioral|Parent reminder|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
16292841|NCT00696449|Behavioral|Standard of care|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
16292842|NCT00696436|Drug|Azilsartan medoxomil|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.
~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
16292843|NCT00696436|Drug|Azilsartan medoxomil|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.
~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
16292844|NCT00696436|Drug|Valsartan|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.
~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
16292845|NCT00696436|Drug|Olmesartan|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.
~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
16292846|NCT00696436|Drug|Placebo|Matching placebo, orally, once daily for up to six weeks.
16292847|NCT00696423|Biological|Infanrix™|Intramuscular injection, one dose
16292848|NCT00696423|Biological|Hiberix™|Intramuscular injection, one dose
16292849|NCT00696410|Drug|Zinc Acetate|Zinc acetate 50 mg po TID for 10 months. Dose will be titrated to achieve ceruloplasmin levels ~10-12.
16292850|NCT00696384|Drug|Azilsartan medoxomil|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.
~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
16292851|NCT00696384|Drug|Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications.|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32.
16292852|NCT00696384|Drug|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks/Week 32.
16292853|NCT00696358|Radiation|308nm excimer lamp|50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
16292854|NCT00696358|Radiation|308nm excimer laser|50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms)
16292855|NCT00696332|Drug|Talampanel|capsules Talampanel, 3 times per day, 52 weeks
16292856|NCT00696332|Drug|Talampanel|capsules Talampanel, 3 times per day, 52 weeks
16292857|NCT00696332|Other|placebo|capsules, placebo, 3 times a day, for 52 weeks
16292858|NCT00696319|Other|Exercise protocol with perturbation exercises.|Perturbation exercises are exercises for balance and stability that involves perturbations of the surface through use of custom made equipment (a rollerboard, a rockerboard and a platform).
16292859|NCT00696319|Other|Exercise protocol with traditional exercises for stability and balance.|The exercise protocol will consist of exercises for balance and stability that do not include sudden disturbances or perturbations to the surface.
16292860|NCT00696293|Drug|Duloxetine|Duloxetine up to 120 mg/day + Clinical Management
16292861|NCT00696280|Behavioral|Functional Living Index - Emesis|
16292862|NCT00696254|Behavioral|Nerve excitability measurement|
16292863|NCT00696241|Drug|Azilsartan medoxomil and olmesartan|Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.
16292864|NCT00696241|Drug|Azilsartan medoxomil and olmesartan|Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.
16292865|NCT00696241|Drug|Azilsartan medoxomil and olmesartan|Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
16292866|NCT00696241|Drug|Olmesartan|Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
16292867|NCT00696241|Drug|Placebo|Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.
16292868|NCT00696228|Dietary Supplement|Placebo|Placebo
16292869|NCT00696228|Dietary Supplement|MUFA|MUFA
16292870|NCT00696228|Dietary Supplement|PUFA|PUFA
16292871|NCT00696228|Dietary Supplement|SFA|SFA
16292872|NCT00696215|Drug|placebo|Placebo 1 mg once a day
16292873|NCT00696215|Drug|rasagiline|1mg
16292874|NCT00696202|Drug|Mirena (BAY86-5028)|Intrauterine levonorgestrel containing device (market product)
16292875|NCT00696176|Drug|STAT 3 DECOY|single administration to a head and neck tumor
16292876|NCT00696163|Drug|biphasic insulin aspart 30|Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion
16292877|NCT00696150|Procedure|determination of method with highest efficacy (ultrasound or nerve stimulator)|Use of ultrasound to guide the insertion of anterior psoas compartment block
16292878|NCT00696150|Procedure|nerve stimulator|The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
16292879|NCT00696150|Procedure|loss of resistance|Use of ultrasound to guide the insertion of anterior psoas compartment block
16292880|NCT00696137|Drug|BEMA Fentanyl|buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
16292881|NCT00696124|Biological|VM202 2mg|2mg intramuscular injection with the first half of the total dose given on Day 1 and the second half on Day 15
16292882|NCT00696124|Biological|VM202 4mg|4mg intramuscular injection, with half of the total dose given on Day 1 and the second half given on Day 15
16292883|NCT00696124|Biological|VM202 8mg|8mg intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
16292884|NCT00696124|Biological|VM202 16mg|16mg dose intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
16292888|NCT00696098|Other|sodium butyrate|1 enema (60 ml) once daily containing 100mM
16292889|NCT00696098|Other|NaCl|1 enema (60 ml) once daily containing 0.9%NaCl
16292890|NCT00696085|Behavioral|Brief motivational intervention|The women who have positive alcohol screening questionnaires and a random sample of women who screen negative are entered into the next phase of the study. They have blood drawn for the markers of alcohol use, are told of the results and are given brief intervention about alcohol use.
16292891|NCT00696072|Drug|Dasatinib|Tablets, Oral, 100 mg once daily, up to 2 years
16292892|NCT00696072|Drug|Letrozole|Tablets, Oral, 2.5 mg, once daily, up to 2 years
16292893|NCT00696059|Drug|Adalimumab (Humira)|Adalimumab (Humira) 40 mg subcutaneously every other week
16292894|NCT00696046|Procedure|Intrabone Marrow Injection|Cord blood CB units will be thawed in a 37° CB cells will be resuspended in 20ml salinesolution + dextran/albumin, and aliquoted in 4 syringes of 5ml Pts were prepared in a surgical & steril room The anaesthesia consist in a short propofol sedation The injection will last 8-15 minutes. 1° sedation is established, a standard needle for bone marrow aspiration (14 gauge) was inserted few cms in the supero-posterior iliac crest then, an aspiration of about 0.5-1 ml will be performed to assess that the needle was securely introduced in the bone marrow cavity After, we will insert the syringe containing 4-5ml of CB cell suspension which will be gently infused This procedure will be then repeated for all the remaining aliquots at a distance of 2-3cm from the previous one following the iliac crest
16292895|NCT00696033|Drug|Diazepam|Diazépam drug (0,3 mg/kg) on a single oral intake
16292896|NCT00696033|Drug|Lorazepam|Lorazépam drug (0,038 mg/kg) on a single oral intake
16292897|NCT00696033|Drug|placebo|lorazépam placebo or Diazépam placebo
16292898|NCT00696020|Drug|BI 1744 CL/tiotropium bromide fixed dose combination|BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
16292899|NCT00696020|Drug|tiotropium bromide|tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
16292900|NCT00696020|Device|Respimat® Inhaler|
16292901|NCT00696007|Drug|Gemcitabine and cisplatin|"Neoadjuvant chemotherapy (gemcitabine and cisplatin) administered before Nephroureterectomy.
~Chemotherapy regimen of three cycles of gemcitabine and cisplatin, dosed over a 3 month period Each cycle would consist of gemcitabine and cisplatin on day 1, with two other doses of gemcitabine on day 8 and day 15.
~Gemcitabine dosing would be 1,000 mg/m² and cisplatin would be dosed at 70 mg/m²"
16292902|NCT00696007|Other|Retrospective comparison|60 retrospective historical cohort group of subjects who have undergone a radical nephroureterectomy over the past five years
16292903|NCT00695994|Drug|Docetaxel|Docetaxel will be administered at a dose of 75 mg/m2 given as a 1-hour intravenous infusion on day 1 of a 21-day cycle. Docetaxel is re-constituted in 500 mL of normal saline and infused through a peripheral or central venous line. Docetaxel (Taxotere®, Sanofi-Aventis Inc.) is available in 80 mg and 20 mg in 2 mL polysorbate 80, 13% (w/w) ethanol in Water for Injection.
16292904|NCT00695994|Drug|gemcitabine and carboplatin|"Gemcitabine (Gemzar®, Lily Inc.) is available in vials containing 1000 mg or 200 mg of active drug formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder.
~Carboplatin (Spectrum Pharmaceuticals, Inc.) is supplied as a 10 mg/mL aqueous solution. Unopened vials of gemcitabine are stable when stored at controlled room temperature at 25°C, protected from bright light. It can be diluted in normal saline or 5% dextrose. The solution remains stable for 8 hours at 25°C after reconstitution.
~Carboplatin will be administered as a 1-hour infusion on day 1 of a 21-day cycle. It will be given before gemcitabine at the dose to achieve an AUC of 5 using the Calvert formula.
~Gemcitabine will be administered as a 30-minute infusion at the dose of 1000 mg/m2 in 250 mL over 30 minutes, on day 1 and 8 of a 21-day cycle. It will be given after carboplatin infusion."
16292905|NCT00695981|Procedure|Rotator cuff repair|Rotator cuff repair + physical therapy according to a standardized protocol
16292906|NCT00695981|Procedure|Conservative treatment|Physiotherapy according to a standardized protocol
16292907|NCT00695955|Drug|Azilsartan medoxomil with or without add-on chlorthalidone|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
16292908|NCT00695955|Drug|Azilsartan medoxomil with or without add-on hydrochlorothiazide|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
16292909|NCT00695929|Drug|Levosimendan|Intravenous injection
16292910|NCT00695929|Drug|Milrinone|Intravenous injection
16292911|NCT00695916|Procedure|Breast MRI|
16292912|NCT00695903|Drug|daptomycin|daptomycin 10 mg/kg IV every 24 hours
16292913|NCT00695903|Drug|vancomycin|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
16292914|NCT00695877|Biological|Ad5.ENVA.48 HIV-1 vaccine|Recombinant adenovirus serotype 5 HIV-1 vaccine
16292915|NCT00695864|Drug|Ondansetron and Placebo crossover|
16292916|NCT00695851|Drug|PCK3145|i.v. bolus either 15 mg/m2 weekly of PCK3145.
16292917|NCT00695851|Drug|PCK3145|by i.v. bolus 7.5 mg/m2 twice per week of PCK3145
16292918|NCT00695825|Dietary Supplement|Low GI+high GI|Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
16292919|NCT00695825|Dietary Supplement|High GI+low GI|Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
16292922|NCT00695747|Procedure|2 Site procedure- Phacoemulsification/IOL and Trabeculectomy|2 Site Combined Procedure: in which a temporal clear cornea approach would be used for the cataract/IOL part of the procedure, and immediately thereafter the superior limbus would be employed for a limbus-based trabeculectomy
16292923|NCT00695708|Behavioral|Brain Fitness Program|Computer-aided cognitive program designed for intensive training of auditory perception, memory and attention
16292924|NCT00695708|Behavioral|Cogpack|Computer-aided cognitive program for cognitive abilities
16292925|NCT00695682|Drug|intravitreal injection of infliximab|All subjects will receive 0.5 mg/ 0.05 mL of infliximab by intravitreal injection at their first treatment visit or the 6 weeks visit if eligible for a repeat injection.
16292926|NCT00695669|Biological|Influenza A (H5N1) Virus Monovalent Vaccine|Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
16292927|NCT00695643|Drug|Mesalazine|3 g per day
16292928|NCT00695643|Drug|Placebo|0 g per day
16292929|NCT00695630|Drug|Flumazenil|2 mL, 0.2 mg SM
16292930|NCT00695630|Drug|Placebo|2 mL sterile saline SM
16292931|NCT00695617|Drug|trisodiumcitrate|trisodiumcitrate 1.035 M
16292932|NCT00695617|Drug|trisodiumcitrate|trisodiumcitrate 1.035 M
16292933|NCT00695604|Drug|Placebo|Placebo via MDI.
16292934|NCT00695604|Drug|Fluticasone|Fluticasone MDI.
16292935|NCT00695591|Other|Evaluation for Nocturnal non invasive ventilation|Patients will be referred for evaluation for NNIV is indicated in patients with diurnal Pa,CO2 >6.0 Pa; and 2) nocturnal Sa,O2 <88% for 5 consecutive min. End tidal CO2 representing equivalent values will be referred for NNIV
16292936|NCT00695578|Drug|Biafine|Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.
16292937|NCT00695578|Drug|Polysporin|over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
16292938|NCT00695565|Drug|Placebo Gel|TID x 12 weeks
16292939|NCT00695565|Drug|Clonidine Topical Gel (ARC-4558)|TID x 12 weeks
16292940|NCT00695552|Behavioral|Aerobic exercise|Aerobic exercise on stationary bikes. Three sessions/week for 3 three months. First month the workload is equivalent to 65% of HRmax, the second month the workload is equivalent to 70% of HRmax, and the third month the workload is equivalent to 75% of HRmax
16292941|NCT00695552|Behavioral|Low impact exercise|Participants meets 3 times/week for 3 months. They will engage in low impact activities such as stretching exercises
16292942|NCT00695526|Dietary Supplement|cranberry|cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.
16292943|NCT00695513|Dietary Supplement|BENEO synergy1|50/50 v/v inulin/oligofructose 10 gram BID
16292944|NCT00695500|Drug|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
16292945|NCT00695500|Drug|Placebo|Placebo tablets, 0 mg per day for 3 weeks
16292946|NCT00695487|Drug|THC 9-d-tetra hydro cannabinol|0.125mg/kg iv one time
16292947|NCT00695461|Dietary Supplement|Lactobacillus plantarum 299v in oatmeal drink|Bacteria in a concentration of 10(9) CFU/ml
16292948|NCT00695461|Dietary Supplement|Oatmeal drink|Oatmeal drink as in arm 1 but without bacteria added.
16292949|NCT00695448|Drug|GSK1059615|GSK1059615 is dosed orally once daily for 21 days of a 28-day cycle. Patients continue treatment for subsequent cycles as long as eligible and receiving benefit.
16292950|NCT00695435|Drug|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline
16292951|NCT00695435|Drug|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline
16292952|NCT00695435|Drug|TOBREX Ophthalmic Solution|TOBREX Ophthalmic Solution 1 drop each eye at baseline
16292953|NCT00695422|Genetic|polymerase chain reaction|PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
16292954|NCT00695422|Other|cytology specimen collection procedure|Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
16292955|NCT00695422|Other|histological technique|Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
16292956|NCT00695422|Procedure|colposcopic biopsy|Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
16292957|NCT00695409|Biological|rituximab|Given IV
16292958|NCT00695409|Drug|carmustine|Given IV
16292959|NCT00695409|Drug|cytarabine|Given IV
16292960|NCT00695409|Drug|etoposide|Given IV
16292961|NCT00695409|Drug|melphalan|Given IV
16292962|NCT00695409|Procedure|ASCT|Undergo autologous peripheral blood stem cell transplant
16292963|NCT00695409|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16292964|NCT00695396|Drug|Placebo|Matching volume 2 mLfor 48 weeks
16292965|NCT00695396|Drug|Epoetin alfa|40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks
16292966|NCT00695396|Drug|Placebo|Matching volume 1 mL for 48 weeks
16292967|NCT00695396|Drug|Epoetin alfa|80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks
16292968|NCT00695383|Behavioral|Bedside cycle exercise therapy|A 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2
16292969|NCT00695383|Behavioral|Standard physiotherapy program|The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.
16292970|NCT00695370|Drug|Pegfilgrastim (drug)|
16292971|NCT00695344|Drug|everolimus|Everolimus 2 times per day, v.o., 2 years treatment.
16292972|NCT00695344|Drug|azathioprine or mycophenolate mofetil|2 times per day during 2 years
16292973|NCT00695331|Drug|Misoprostol|Titrated Misoprostol Solution
16292974|NCT00695331|Drug|Oxytocin|Titrated Intravenous Oxytocin
16292975|NCT00695318|Drug|Fluocinolone Acetonide|0.2 µg/Day in study eye + Sham in fellow eye
16292976|NCT00695318|Drug|Fluocinolone Acetonide|0.5 µg/Day in study eye +Sham in fellow eye
16292977|NCT00695305|Drug|rilapladib|250 mg oral dose once daily
16292978|NCT00695305|Drug|placebo|placebo
16292979|NCT00695305|Other|18F Fluorodeoxylucose (FDG)-PET|FDG-PET
16292980|NCT00695292|Drug|irinotecan|irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
16292981|NCT00695292|Drug|Carboplatin|carboplatin AUC=4 on Day 1
16292982|NCT00695292|Drug|sunitinib|sunitinib 25 mg orally (PO) daily after initial chemotherapy
16292983|NCT00695279|Procedure|Venipuncture|Blood draw
16292984|NCT00695253|Device|Talent Endoluminal Spring Graft System|Endovascular repair for patients with AAA who meet the inclusion criteria for the study
16292985|NCT00695240|Device|Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)|Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. One half percent bupivacaine was utilized.
16292986|NCT00695227|Diagnostic Test|Screening for Barrett's Esophagus|
16292987|NCT00695214|Drug|Propofol sedation|Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.
16293029|NCT00694915|Biological|BCG (Bacillus Calmette-Guerin)|Immunotherapeutic agent
16293030|NCT00694902|Drug|GSK610677|GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose.
16293031|NCT00694902|Drug|Placebo|Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose.
16293076|NCT00694577|Radiation|Partial Breast Irradiation using 36 Gy / 9 fractions|36 Gy- 9 Treatments, 4 1/2 Treatment Days
16292988|NCT00695201|Drug|Floxuridine, Oxaliplatin, CPT-11|For patients on the 4-week cycle: On the first day of each cycle, the pump will be filled with FUDR and dexamethasone. The pump will be emptied of drugs after 2 weeks (on day 15 of each cycle) and filled with heparin (which is used to prevent blood from clotting) and saline. Whether the pump contains drug or heparin and saline, it will need to be emptied and refilled about every two weeks. We will inject either the drugs or the saline and heparin into the pump through the skin using a needle and syringe. In summary, 2 weeks of drug in the pump is followed by 2 weeks without drug in the pump. The systemic chemotherapy (Oxaliplatin/CPT-11) will be administered on the same day as the pump is filled and emptied, ie. Day 1 and Day 15 of each cycle.
16292989|NCT00695201|Drug|Floxuridine, Oxaliplatin, CPT-11|For patients on the 5-week cycle: On the first day of each cycle, the pump will be filled with FUDR and dexamethasone. The pump will be emptied of drugs after 2 weeks (on day 15 of each cycle) and filled with heparin and saline. This is repeated on day 29 of each cycle). In summary, 2 weeks of drug in the pump are followed by 3 weeks without drug in the pump. The systemic chemotherapy (Oxaliplatin/CPT-11) will be administered on the same day that the pump is emptied and filled with heparin and saline, i.e. Day 15 and Day 29 of each cycle.
16292990|NCT00695188|Drug|methotrexate|oral administration Escalating dose (15, 20, 25 mg)
16292991|NCT00695188|Drug|methotrexate|25 mg oral administration
16292992|NCT00695162|Other|quiet|no noise
16292993|NCT00695162|Other|non-speech noise|noise without speech
16292994|NCT00695162|Other|speech noise|noise with speech present
16292995|NCT00695149|Procedure|Transplantation of bone marrow stromal cell|
16292996|NCT00695136|Drug|Donepezil hydrochloride|
16292997|NCT00695136|Behavioral|Increase REM sleep percentage|
16292998|NCT00695110|Drug|Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)|Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
16292999|NCT00695110|Drug|Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)|Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
16293000|NCT00695110|Drug|Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)|Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.
16293001|NCT00695110|Drug|Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)|Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
16293002|NCT00695097|Drug|Rituximab|Rituximab infusion on Day 1 and Day 15
16293003|NCT00695097|Drug|No Rituximab|No Rituximab
16293004|NCT00695084|Behavioral|Constraint-Induced Movement Therapy|Intensive practice with the hemiparetic arm for 30 contact hours
16293005|NCT00695071|Drug|Itraconazole|Oral
16293006|NCT00695058|Device|Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)|"A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the perineum in women and the perineum or the frenulum in men.
~In the women the stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. In the men the vibration parameter/location will be determined by the results of the new pressure profile studies (aim 3).
~A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks in both the women with stress incontinence and overactive bladder syndrome.
~In the 3 groups of patients the subjects will be randomized to either active treatment or placebo treatment. The placebo treatment will be done with a vibration device with an amplitude of 0 mm. Subjects will be randomized by a draw."
16293007|NCT00695045|Drug|intra thecal morphine|100 mcg intrathecal morphine given once .
16293008|NCT00695045|Drug|intra thecal morphine|200 mcg intrathecal morphine given once
16293009|NCT00695045|Drug|intra thecal morphine|300 mcg intrathecal morphine given once
16293010|NCT00695032|Drug|cisplatin|
16293011|NCT00695032|Drug|ifosfamide|
16293012|NCT00695032|Other|laboratory biomarker analysis|
16293013|NCT00695019|Drug|interferon-alpha lozenges|500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
16293014|NCT00695019|Drug|placebo lozenges|200 mg matching placebo lozenges
16293015|NCT00695006|Other|Sham Traction|Traction <5lbs
16293016|NCT00695006|Other|Traction|Standard supine intermittent traction
16293017|NCT00694993|Drug|GSK1004723|GSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
16293018|NCT00694993|Drug|Placebo|Placebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
16293019|NCT00694980|Drug|placebo|Intravenous and subcutaneous escalating doses
16293020|NCT00694980|Drug|rhuMAb Beta7|Intravenous and subcutaneous escalating doses
16293021|NCT00694967|Procedure|McDonald cerclage placement|Transcervical McDonald cerclage placement
16293022|NCT00694967|Drug|17 hydroxyprogesterone caproate|Weekly 250mg intramuscular injections
16293023|NCT00694954|Device|Diagnostic Test - Given Imaging Pillcam|"Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated.
~Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)"
16293024|NCT00694954|Other|Diagnostics|Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.
16293025|NCT00694941|Drug|ONO-2506PO|1200mg QD / 5 years
16293026|NCT00694928|Drug|clindamycin phosphate/butoconazole nitrate|semi-solid, single dose
16293027|NCT00694928|Drug|butoconazole nitrate|semi-solid, single dose
16293028|NCT00694915|Biological|Mycobacterium w|Immunomodulator
16293373|NCT00692237|Drug|Sildenafil|100 mg daily (3 capsules/day)
16293032|NCT00694889|Behavioral|Neuroadaptive cognitive training|Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
16293033|NCT00694889|Behavioral|Computer games|The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
16293034|NCT00694863|Drug|tetracosactide hexacetaat|Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.
16293035|NCT00694850|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521 will be up-titrated from 1,0 mg TID to 2,5 mg TID
16293036|NCT00694837|Drug|nelfinavir|The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.
16293037|NCT00694811|Behavioral|Re-feeding duration|1 or 6 weeks of re-feeding after VLED-induced weight loss
16293038|NCT00694798|Biological|Mycobacterium w|Immunomodulator
16293039|NCT00694785|Drug|ARC1779|"Initial stepwise infusion of 0.14 mg/kg given over 60 minutes and subsequent continuous infusion of an additional 1.7 mg/kg given over the remaining 72 hours at a rate of 0.0004 mg/kg/min.
~Group NT3"
16293040|NCT00694785|Drug|ARC1779|"Initial stepwise infusion of 0.14 mg/kg given over 60 minutes and subsequent continuous infusion of an additional 1.3 mg/kg given over the next 72 hours.
~Group T3"
16293041|NCT00694785|Drug|ARC1779|"Initial stepwise infusion of 0.28 mg/kg given over 60 minutes and subsequent continuous infusion of an additional 3.8 mg/kg given over the remaining 72 hours at a rate of 0.0009 mg/kg/min.
~Group NT6"
16293042|NCT00694785|Drug|ARC1779|"Initial stepwise infusion of 0.28 mg/kg given over 60 minutes and subsequent continuous infusion of an additional 3.0 mg/kg given over the remaining 72 hours.
~Group T6"
16293043|NCT00694772|Procedure|Electrocautery-tonsillectomy|standard of care electrocautery tonsillectomy
16293044|NCT00694772|Procedure|Coblation-tonsillotomy|use of Arthrocare Coblation Technology to perform tonsillotomy
16293045|NCT00694759|Drug|pioglitazone|30 mg for 2 weeks, then 45 mg daily
16293046|NCT00694759|Drug|metformin|500mg twice daily for 1 week, then 1000 mg twice daily
16293047|NCT00694759|Drug|placebo|capsule twice daily
16293048|NCT00694746|Drug|Omega-3-acid ethyl esters|Participants will receive 2 capsules of 1 gram of fish oil with meals twice a day for a period of six months (including a ramp up period of three weeks)
16293049|NCT00694746|Drug|Placebo|Participants will receive 2 capsules of 1 gram of placebo with meals twice a day for a period of six months (including a ramp up period of three weeks)
16293050|NCT00694733|Drug|Placebo injection|Normal saline injection IM monthly for 4 months
16293051|NCT00694733|Drug|Depo Lupron/Aromatase inhibitor|Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.
16293052|NCT00694733|Drug|Depo Lupron/placebo|Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.
16293053|NCT00694733|Drug|placebo|Placebo Cream 1ml applied twice daily for four months
16293054|NCT00694733|Drug|Estrogen cream|Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.
16293055|NCT00694720|Drug|AVE0657|capsules once a day at bedtime
16293056|NCT00694720|Drug|placebo|capsules once a day at bedtime
16293057|NCT00694707|Drug|Placebo|Placebo was supplied in capsules.
16293058|NCT00694707|Drug|Cariprazine|Cariprazine was supplied in capsules
16293059|NCT00694707|Drug|Risperidone|Risperidone was supplied in capsules
16293060|NCT00694694|Drug|azithromycin + artesunate|Azithromycin 20mg/kg per day for three days (total 60 mg/kg) Artesunate 4mg/kg per day for 3 days
16293061|NCT00694694|Drug|artemether-lumefantrine|"Tablets are fixed-dose combinations and contain 20mg artemether and 120mg lumefantrine.
~For children 5-14.9kg 1 tab 2x a day for 3 days For children 15-24.9kg 2 tablets 2x a day for 3 days For children 25-35kg 3 tablets 2x a day for 3 days"
16293062|NCT00694681|Behavioral|Telephonic care management|Individuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone.
16293063|NCT00694668|Behavioral|Cognitive Behavioral treatment|Brief cognitive behavioral therapy (12 sessions)
16293064|NCT00694668|Behavioral|Mindfulness based cognitive therapy|9 sessions MBCT in a group-format (up to 8 persons)
16293066|NCT00694642|Biological|Selected CD 133+ cells|Endothelial progenitor cell CD 133
16293067|NCT00694629|Drug|rifampin|tablet, 10 mg/kg, daily, 8 weeks
16293068|NCT00694629|Drug|rifapentine|tablet, 10 mg/kg, daily, 8 weeks
16293069|NCT00694629|Drug|rifapentine|tablet, 15 mg/kg, daily, 8 weeks
16293070|NCT00694629|Drug|rifapentine|20 mg/kg, daily, 8 weeks
16293071|NCT00694616|Device|AutoSet Spirit|3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
16293072|NCT00694616|Device|Modified-AutoSet Spirit|3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
16293073|NCT00694603|Drug|Cetuximab|Given intravenously once per week.
16293074|NCT00694590|Drug|plerixafor|"Drug Course 1: plerixafor (20mg/mL). Dose escalation starting with 80 mcg/kg then 160, 240, 320, 420, and 540 mcg/kg, or to de-escalate to 40mcg/kg. Dosing 3 times/week for 3 weeks beginning at start of second week. Rituximab is also administered 3 times per week for 4 weeks using a fixed dose of 100 mg on Day 1 and a dose of 375 mg/m2 for all subsequent doses.
~Drug Course 2: plerixafor (20 mg/m) same dose as course 1. Dosing 3 times/week for 4 weeks. Rituximab is also administered 3 times per week for 4 weeks using a dose of 375 mg/m2 for all doses."
16293075|NCT00694577|Radiation|Partial Breast Irradiation using 32 Gy / 8 fractions|32 Gy-8 Treatments, 4 Treatment Days
16293077|NCT00694577|Radiation|Partial Breast Irradiation using 40 Gy /10 fractions|40 Gy-10 Treatments, 5 Treatment days
16293078|NCT00694564|Drug|S-adenosyl methionine|S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
16293079|NCT00694551|Biological|Peptide Vaccine|Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
16293080|NCT00694551|Drug|Poly IC-LC|Administered subcutaneously, one 2 mg/ml vial,(divided into two equal portions for each injection site).
16293081|NCT00694538|Device|Interferential Laser therapy|Two GaAlAs laser (810 nm, 100mW)were used. In the interferential laser treatment, two probes were simultaneously applied. In the conventional laser group, only one probe was switched on. Laser was applied at five points over the pain area. The laser emission mode was continuous with an energy dose of 6 joules per point and session, a power density of 1.09 w/cm2 and an irradiation time per point of 60 s. The average output power was 100 mW and the total energy dose delivered in a patient session was 30 J. Every treatment was along 15 sessions. Hence, the accumulated energy delivered on the whole was 450 Joules for the conventional group of patients (using one beam) and 900 Joules for the interferential one (using two beams).
16293082|NCT00694512|Dietary Supplement|Low fat diet|20% fat diet
16293083|NCT00694512|Dietary Supplement|High fat diet|40% fat diet
16293084|NCT00694512|Dietary Supplement|MCT diet|Medium chain triglyceride diet
16293085|NCT00694473|Device|Freestyle Navigator|Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
16293086|NCT00694460|Biological|Three 1 mL doses of Rabies vaccine and two JE vaccine|Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
16293087|NCT00694460|Biological|Three 0.5 mL doses of Rabies vaccine and two JE vaccine|Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
16293088|NCT00694460|Biological|Three 0.1mL doses of Rabies Vaccine and two JE vaccine|Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
16293089|NCT00694460|Biological|Two 0.1mL doses of Rabies vaccine and two JE vaccine|Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
16293090|NCT00694460|Biological|Two doses of JE vaccine|Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)
16293091|NCT00694447|Procedure|Acupuncture|
16293092|NCT00694408|Drug|methyl prednisolone, hydrocortisone, prednisolone|Will be specific dependant on weight of patients
16293093|NCT00694408|Other|No steroids|Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
16293094|NCT00694382|Drug|Semuloparin sodium|"0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16293095|NCT00694382|Drug|Placebo (for semuloparin)|"0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component
~Subcutaneous injection"
16293096|NCT00694369|Drug|Comparator: etoricoxib|etoricoxib 90 mg; 120 mg (once daily) over three days.
16293097|NCT00694369|Drug|Comparator: ibuprofen|ibuprofen 2400 mg (600 mg Q6h) over three Days
16293098|NCT00694369|Drug|Comparator: acetaminophen + codeine|acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
16293099|NCT00694369|Drug|Comparator: placebo|matching placebo over three Days
16293100|NCT00694356|Biological|Dalotuzumab|IV infusion
16293101|NCT00694343|Drug|HES 130/0.4 (6%) in sodium chloride (solution for infusion)|500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
16293102|NCT00694343|Drug|Ringer's Lactate solution|1000 mL Ringer's Lactate solution
16293103|NCT00694330|Biological|GM-K562 Vaccination|Lethally irradiated autologous glioma cells combined with GM-K562 cells as vaccine therapy given once a week for three weeks then every other week.
16293104|NCT00694317|Drug|Zaleplon|Short term treatment of insomnia
16293105|NCT00694304|Drug|Vortioxetine (Lu AA21004)|2.5, 5, or 10 mg/day; tablets; orally
16293106|NCT00694291|Drug|Sorafenib|400 mg orally twice daily
16293107|NCT00694291|Drug|Placebo|Matching Placebo
16293108|NCT00694265|Procedure|Decompression|Surgical decompression of the median nerve
16293109|NCT00694265|Procedure|Conservative treatment|Conservative treatment typically consisted of splinting and corticosteroid injections
16293110|NCT00694252|Drug|Lapatinib|Patients will receive lapatinib monotherapy 1500 mg/day for a period of at least one month depending on their response and the clinical status of their disease.
16293111|NCT00694239|Behavioral|Knowledge of Cardiovascular Risk Assessment|Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.
16293112|NCT00694226|Behavioral|brief motivational intervention|Brief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills.
16293374|NCT00692237|Drug|Placebo|Placebo 100 mg (3 capsules/day)
16293113|NCT00694226|Behavioral|treatment as usual|Treatment as usual (TTU): After completion of the intervention, individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis.Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol.
16293114|NCT00694213|Biological|VCL-IPM1|IM, 0.5 mg/mL, 2 injections, 0 and 21 days
16293115|NCT00694213|Biological|VCL-IPM1|IM, 1 mg/mL, 2 injections, 0 and 21 days
16293116|NCT00694213|Biological|VCL-IPT1|IM, 1 mg/mL, 2 injections, 0 and 21 days
16293117|NCT00694213|Biological|PBS|IM, 1 mL, 2 injections, 0 and 21 days
16293118|NCT00694200|Drug|Vinorelbine|Vinorelbine per os 50 mg 3 times a week
16293119|NCT00694200|Drug|Bevacizumab|Bevacizumab 10 mg/kg IV every 14 days
16293120|NCT00694187|Drug|Zaleplon|
16293121|NCT00694174|Drug|sucrose 24% oral solution|sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance
16293122|NCT00694174|Drug|sterile water|sterile water 2 ml single dose to be administered orally one time prior to heel lance
16293123|NCT00694161|Drug|Fx-1006A|Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for 12 months
16293124|NCT00694148|Drug|NT 201|"A Botulinum neurotoxin type A, free of complexing proteins
~Detailed described in study protocol"
16293125|NCT00694135|Drug|EGP-437 1.6 mA-min at 0.4 with EyeGate® II System|Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
16293126|NCT00694135|Drug|EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System|Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
16293127|NCT00694135|Drug|EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System|Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
16293128|NCT00694135|Drug|EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System|Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
16293129|NCT00694122|Drug|Lantus (glargine)|Described in Arm Description
16293130|NCT00694109|Drug|Mipomersen Sodium|Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.
16293131|NCT00694096|Drug|Sunitinib|"Imaging studies with complete analyses will be provided on all patients prior to institution of sunitinib therapy as well as after therapy at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients or 4 weeks in 5 patients) after institution of sunitinib therapy at 37.5 mg orally/day.
~Imaging studies include:
~FDG-PET scans FLT-PET scans H215O-PET scans DCE-MRI scans"
16293132|NCT00694083|Drug|Ridaforolimus|Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles)
16293133|NCT00694057|Drug|HE3286|HE3286 10 mg per day (5 mg BID)
16293134|NCT00694057|Drug|Placebo|Placebo capsules BID
16293135|NCT00694044|Drug|varenicline|0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
16293136|NCT00694044|Drug|varenicline|0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
16293137|NCT00694044|Drug|varenicline|0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
16293138|NCT00694044|Drug|Placebo|Placebo for 21 days
16293139|NCT00694031|Procedure|Hemodialysis|3 times per week
16293140|NCT00694031|Procedure|On-line hemodiafiltration|3 times per week
16293141|NCT00694018|Other|Education and standard care|Educational program for individuals with chronic back pain.
16293142|NCT00694018|Behavioral|Internet mediated enhanced pedometer intervention|Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
16293143|NCT00694005|Procedure|kissing balloon|simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
16293144|NCT00694005|Procedure|"without kissing balloon angioplasty leave alone"|simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
16293145|NCT00693992|Other|Laboratory Biomarker Analysis|Correlative studies
16293146|NCT00693992|Other|Placebo|Given PO
16293147|NCT00693992|Other|Quality-of-Life Assessment|Ancillary studies
16293148|NCT00693992|Drug|Sunitinib Malate|Given PO
16293149|NCT00693979|Device|TAXUS Element Stent or TAXUS Express Stent|Paclitaxel was selected as the drug to coat the stent because it is known to prevent the uncontrolled cell growth that contributes to the narrowing of artery, by interfering with the ability of cells to divide and multiply. Because of these properties, it has been used as a drug for the treatment of various types of cancer. Cancer patients are given paclitaxel as a solution into the vein. For this study, paclitaxel will be administered locally to the wall of coronary artery as a coating on the stent. Cancer patients receive a dose of paclitaxel approximately 1100 - 1400 times greater than the dose used in the coating of the stent. It is highly unlikely that levels of paclitaxel in the blood would be measurable or have effects anywhere beyond the heart.
16293150|NCT00693966|Biological|MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)|IM injection
16293151|NCT00693966|Biological|MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)|IM injection
16293152|NCT00693966|Biological|MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)|IM injection
16293153|NCT00693966|Biological|MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)|IM injection
16293154|NCT00693940|Behavioral|Group mediated cognitive behavioral (GMCB) sessions|GMCB will include weekly group exercise sessions, lasting approximately 60 to 75 minutes each for a 6 month period. During these sessions, participants will be asked to exercise by walking around a track. There will also be a group discussion, led by a facilitator, who will help participants find ways to increase the frequency of their walking exercise at home. After completing the GMCB sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.
16293155|NCT00693940|Other|Health education sessions|Health education will include weekly educational sessions on a health-related topic, lasting approximately 60 minutes each. After completing the health education sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.
16293156|NCT00693927|Procedure|Unmanipulated PBSC after nonmyeloablative conditioning|"Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2).
~Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor"
16293157|NCT00693927|Procedure|CD8-depleted PBSC after nonmyeloablative conditioning|
16293158|NCT00693914|Behavioral|Series of tests/questionnaires|Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
16293159|NCT00693901|Behavioral|Community-based participatory research (CBPR)|CBPR will involve park advisory boards and community members in the research process, including the park assessments and data analysis. The assessment research will be used to inform use of discretionary funds for park programming and facilities in the hopes of increasing community physical activity. Park directors will be provided with analysis of descriptive information and community feedback to help improve outreach, park programming, and features to attract more park users and increase physical activity.
16293160|NCT00693901|Behavioral|Director-only|Park directors will be provided with descriptive information on park use and community feedback. They will also receive assistance on how to improve outreach, programming, and park features that will increase park use and physical activity. These parks will not take part in any assessments.
16293161|NCT00693888|Behavioral|advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)|initial comprehensive assessment, stratified (city, suburbs) randomization into two groups: interventional group: individual comprehensive primary advice (medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives), control group: standard support, observation over a period of 6 months, possibility of completing the diagnostic after final assessment
16293162|NCT00693862|Drug|levodopa, carbidopa, entacapone|
16293163|NCT00693862|Drug|levodopa, carbidopa|
16293164|NCT00693849|Drug|Escitalopram|10 mg/day as a single dose, increased to max 20 mg/day
16293165|NCT00693849|Drug|Sertraline|50 mg/day as a single dose, increased to max of 200 mg/day
16293166|NCT00693849|Drug|Venlafaxine-XR|75 mg/day given once daily; increased to 150-225 mg/day
16293167|NCT00693836|Genetic|genetic linkage analysis|
16293168|NCT00693836|Genetic|loss of heterozygosity analysis|
16293169|NCT00693836|Genetic|mutation analysis|
16293170|NCT00693836|Genetic|polymerase chain reaction|
16293171|NCT00693836|Genetic|polymorphism analysis|
16293172|NCT00693836|Other|biologic sample preservation procedure|
16293173|NCT00693836|Other|medical chart review|
16293174|NCT00693836|Other|questionnaire administration|
16293175|NCT00693836|Procedure|evaluation of cancer risk factors|
16293176|NCT00693823|Procedure|Femoral-popliteal Bypass|Surgical placement of a prosthetic graft in the thigh from the groin to the knee
16293177|NCT00693823|Device|Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery|Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
16293178|NCT00693784|Biological|Biostat® Disc Augmentation System|Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device
16293179|NCT00693771|Drug|Insulin Glargine|Once daily and up-titrate accordingly
16293180|NCT00693758|Drug|adenosine|intravenous infusion of adenosine (140microgr./min/kg)
16293181|NCT00693758|Other|modified end-tidal forcing system|changes in partial pressures of O2 and CO2 in inspired air
16293182|NCT00693758|Other|arm cuff occlusion|3 min. lasting upper arm cuff occlusion
16293183|NCT00693758|Device|Breathing gas|Changes in pO2 and pCO2 in inspired air mix
16293184|NCT00693758|Device|Blood pressure cuff|supra-systolic arm occlusion with pressure cuff
16293185|NCT00693732|Drug|Escitalopram treatment|On study inclusion at Visit 2, patients will be successively randomised using a computer generated randomisation list to either placebo or escitalopram (Lundbeck Export A/S, Singapore) 10mg given at bedtime in the first 2 weeks, followed by 20mg in the next 6 weeks. The treatments will be identical in appearance and will be administered in double-blind fashion. Treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator are prohibited during the entire study.
16293186|NCT00693732|Behavioral|Quantitative sensory testing|Rectal Distention Stimulation
16293187|NCT00693719|Drug|Etoposide|50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
16293188|NCT00693719|Drug|Irinotecan hydrochloride|Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
16293189|NCT00693706|Biological|Trivalent influenza vaccine GSK 138842A|IM injection on Day 0
16293190|NCT00693706|Biological|Fluarix|IM injection on Day 0
16293191|NCT00693693|Drug|hydrocortisone 17-butyrate 0.1% Cream preparation|Apply medication twice a day to affected areas of atopic dermatitis
16293192|NCT00693693|Drug|hydrocortisone 17-butyrate 0.1% Ointment preparation|Apply medication twice a day to affected areas of atopic dermatitis
16293193|NCT00693693|Drug|hydrocortisone 17-butyrate 0.1% Lipocream preparation|Apply medication twice a day to affected areas of atopic dermatitis
16293194|NCT00693680|Dietary Supplement|Zincas Forte|25 mgZn/day + imipramine (100-200mg/day)
16293195|NCT00693680|Dietary Supplement|Placebo|placebo + imipramine (100-200mg/day)
16293196|NCT00693667|Drug|PH3|Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
16293197|NCT00693654|Drug|Sarna|Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide
16293369|NCT00692263|Drug|escitalopram and tramadol|10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9
16293198|NCT00693654|Drug|Cetaphil|Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid
16293199|NCT00693641|Other|Safe Sea sun lotion with jellyfish sting protection SPF 15|Prevent or significantly reduce jellyfish sting using sun lotion with a jellyfish sting inhibitor. The amount of lotion applied to the skin before spreading is the same as for regular sun lotion 2.00 mg.cm-²± 2.5%.
16293200|NCT00693641|Other|Nivea sun, caring sun lotion SPF 15|The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.
16293201|NCT00693628|Device|compression shrinker|Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker
16293202|NCT00693615|Biological|MEDI-517 HPV-16/18 VLP AS04 vaccine|IM injection
16293203|NCT00693615|Biological|MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3|IM injection
16293204|NCT00693615|Biological|MEDI-517 HPV-16/18 VLP vaccine without adjuvant|IM injection
16293205|NCT00693602|Drug|Erwinase|Chemotherapy
16293206|NCT00693589|Drug|folic acid, vitamin B12 and B6 and rosuvastatin|Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks
16293207|NCT00693576|Drug|simvastatin|20 mg simvastatin daily
16293208|NCT00693563|Behavioral|Scheduled Telephone Intervention|Participants and their significant others will be contacted by telephone within 24 to 48 hours after discharge and 10 additional times at weeks 1, 2, 4, 6, and months 2, 3, 4, 6, 8, and 10. The frequent early telephone contacts are meant to address early concerns that frequently arise after discharge are expected to last between 30 and 45 minutes. Later phone calls may be brief if no concerns are raised and are expected to address resource needs as well as ongoing questions that arise through the first year after injury. Content of each phone call will be dependent on issues raised by each individual participant and their significant other and/or follow-up on concerns raised in prior phone contacts rather than a specific structured interview.
16293209|NCT00693550|Other|metal patch tests|Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days
16293210|NCT00693537|Behavioral|Exercise training|4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)
16293211|NCT00693524|Drug|tacrolimus|oral
16293212|NCT00693524|Drug|Anti-IL2R AB|i.v.
16293213|NCT00693524|Drug|Mycophenolate mofetil|oral
16293214|NCT00693524|Drug|prednisone|oral
16293215|NCT00693511|Behavioral|Circuit Training|Circuit Training (aerobic + strength training 2 times per week for 16 weeks)
16293216|NCT00693511|Behavioral|Circuit training + motivational interviewing|Circuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions)
16293217|NCT00693498|Biological|Standard leukoreduced irradiated blood cell transfusion|standard vs washed blood cell transfusions
16293218|NCT00693498|Biological|Washed leukoreduced irradiated blood cell transfusions|washed leukoreduced irradiated blood cell transfusions
16293219|NCT00693485|Drug|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
16293220|NCT00693485|Drug|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
16293221|NCT00693485|Drug|Sham (no implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
16293222|NCT00693472|Drug|Preladenant|Preladenant, one 25 mg capsule, administered orally every 12 hours
16293223|NCT00693472|Drug|Placebo|Matching placebo capsule administered orally every 12 hours
16293224|NCT00693472|Drug|Anticholinergic agents or propanolol|"Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.
~Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol."
16293225|NCT00693472|Drug|Haloperidol|Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day
16293226|NCT00693459|Device|Circular Anal Dilator for Transanal Hemorrhoidectomy|The Circular Anal Dilator for Transanal Hemorrhoidectomy (product #CAD01) allows the standard of care Ferguson hemorrhoidectomy to be performed and does not alter the steps of the operation. The presumed advantages are the ability of the dilator to guide an accurate dissection and also to decrease the overall time it takes to perform hemorrhoidectomy.
16293227|NCT00693446|Drug|Sirolimus|"In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.
~In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time.
~The initial dose will be 8 mg/day po. till a trough level is obtained and then titrated to maintain trough whole-blood concentrations between 5-15ng/ml.
~The dose of sirolimus will be administrated once a day."
16293228|NCT00693446|Drug|Tacrolimus|"Patients receive Tacrolimus from day 0 to the end of the study. The time of first administration will be within the first 48 hours post transplant.
~The dose of tacrolimus will be administrated twice a day. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.
~Patients receive also rATG , mycophenolate mofetil and corticosteroids."
16293229|NCT00693433|Drug|dexamethasone|Given orally
16293230|NCT00693433|Drug|temsirolimus|Given IV
16293231|NCT00693433|Other|laboratory biomarker analysis|Correlative studies
16293232|NCT00693420|Drug|Bimatoprost 0.03% sterile solution|Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.
16293233|NCT00693420|Drug|vehicle sterile solution|Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily
16293370|NCT00692263|Drug|placebo|placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol
16293234|NCT00693407|Procedure|gastric capsaicin with heterotopic stimulation/ distraction|The subjects are randomized to swallow either a capsaicin 0.50mg capsule or an identical placebo capsule with 100ml of water If after 15 minutes pain scores do not reach a minimum level of 30, a further double-blinded capsule of the same content will be swallowed with 100ml of water. This is repeated to a maximum of 8 capusles until pain with VAS >30 is reported.
16293235|NCT00693381|Drug|Tacrolimus|oral
16293236|NCT00693381|Drug|Mycophenolate Mofetil|oral
16293237|NCT00693381|Drug|methylprednisolone and prednisone|IV and oral
16293238|NCT00693355|Other|Sodium butyrate|sodium butyrate
16293239|NCT00693355|Other|NaCl|NaCl
16293240|NCT00693342|Biological|immunological adjuvant OPT-821|Given subcutaneously
16293241|NCT00693342|Biological|polyvalent antigen-KLH conjugate vaccine|Given subcutaneously
16293242|NCT00693316|Drug|ORM-12741|Alternating panel single dose escalation.
16293243|NCT00693303|Behavioral|Handwriting Training using My Scrivener|Subjects received 20 minutes of training per week which included writing letters and words with the My Scivener device.
16293244|NCT00693290|Other|low residue diet|Fleet (usual preparation) plus diet sheet for low residue diet
16293245|NCT00693264|Dietary Supplement|Hoodia Gordonii|750 mg capsule will be taken one time
16293246|NCT00693264|Dietary Supplement|Placebo|Placebo capsule to be taken one time
16293247|NCT00693251|Procedure|Crush technique|Crush technique
16293248|NCT00693251|Procedure|provisional T stenting|Provisional T stenting
16293249|NCT00693238|Radiation|Low Risk Proton Radiation|
16293250|NCT00693238|Radiation|Intermediate Risk Proton Radiation|
16293251|NCT00693225|Drug|Omeprazole/sodium bicarbonate|Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks.
16293252|NCT00693212|Drug|methylphenidate|Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
16293253|NCT00693212|Drug|methylphenidate|Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day
16293254|NCT00693212|Drug|placebo|Dosing is identical to the MPH arm except that the pills will contain no active medication.
16293255|NCT00693199|Drug|amlodipine|amlodipine 5mg once daily for 28 days
16293256|NCT00693199|Drug|terazosin|terazosin 2 mg once daily for 28 days
16293257|NCT00693199|Drug|amlodipine plus terazosin|amlodipine 5 mg plus terazosin 2 mg once daily for 28days
16293258|NCT00693186|Biological|HBVaxPRO® 5 µg / 0.5 mL|5 µg / 0.5 mL
16293259|NCT00693186|Biological|Engerix B® 10 µg / 0.5 mL|10 µg
16293260|NCT00693160|Drug|ketorolac|single intrathecal injection of ketorolac 2 mg
16293261|NCT00693160|Drug|placebo|subject will receive a placebo (preservative free normal saline) spinal injection
16293262|NCT00693160|Drug|remifentanil|All subjects will receive a remifentanil infusion
16293263|NCT00693160|Drug|Capsaicin|Topical capsaicin pain model utilized for each subject
16293264|NCT00693147|Procedure|Total Thyroidectomy|Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)
16293265|NCT00693121|Drug|Amantadine hydrochloride|100mg administered orally twice daily x 14 days
16293266|NCT00693121|Drug|Placebo capsule|capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days
16293267|NCT00693108|Drug|Transdermal testosterone|
16293268|NCT00693095|Biological|CMV-ALT + CMV-DCs|CMV-ALT (3 X 10e7) with CMV-DCs (2 X 10e7)
16293269|NCT00693095|Biological|CMV-ALT + Saline|CMV-ALT (3 X 10e7) with Saline
16293270|NCT00693082|Dietary Supplement|flaxseed|1 tablespoon a day for first three days, increasing to two tablespoons a day for the next three days. On the 7th day start with 3 tablespoons per day and maintain dose throughout the duration of the study (11 weeks).
16293271|NCT00693069|Drug|Clopidogrel|clopidogrel 300 mg on the day prior to angiography
16293272|NCT00693069|Drug|Clopidogrel|clopidogrel 600 mg on the day prior to angiography
16293273|NCT00693069|Drug|Clopidogrel|clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography
16293274|NCT00693069|Drug|Clopidogrel|clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography
16293275|NCT00693056|Drug|Placebo|Placebo (w/o API)
16293276|NCT00693056|Drug|RX-10100 5mg|5 mg/dose of RX-10100
16293277|NCT00693056|Drug|RX-10100 10mg|10 mg/dose of RX-10100
16293278|NCT00693056|Drug|RX-10100 15mg|15 mg/dose of RX-10100
16293279|NCT00693043|Drug|lidocaine hydrochloride|Study group will have up to 2 mg/kg of Lidocaine administered to the skin and additional Lidocaine(3mg/kg)infused through an atomizer using a specialized tip attached to the sterile leur lock syringe into the pleural cavity. The Intrapleural lidocaine dose will be given in a fixed dose of 3 mg/kg. Serum levels will be obtained at 30, 60, and 120 minutes after initial intradermal administration
16293280|NCT00693030|Device|sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)|comparison of multiple drug eluting stents
16293281|NCT00693030|Device|paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)|comparison of multiple drug eluting coronary stents
16293282|NCT00693030|Device|zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)|comparison of multiple drug eluting coronary stents
16293283|NCT00693030|Device|Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)|comparison of DES in overlap vs BMS in overlap
16293284|NCT00693017|Drug|Zonisamide|"50-400 mg capsules once daily in the evening orally.
~Maximum study duration 28 weeks comprising:
~Baseline Period (Week -8 to Week 0): no treatment
~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
~Down Titration Period (4 Weeks)"
16293331|NCT00692601|Dietary Supplement|Acute consumption of Capsiate Natura|10 capsules = 10 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. Each capsule contains 1 mg capsiate.
16293371|NCT00692263|Drug|placebo and tramadol|9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
16293285|NCT00693017|Drug|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
~Maximum study duration 28 weeks comprising:
~Baseline Period (Week -8 to Week 0): no treatment
~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
~Down Titration Period (4 Weeks)"
16293286|NCT00693004|Drug|PRX-03140|
16293287|NCT00693004|Drug|Donepezil|
16293288|NCT00693004|Drug|Placebo|
16293289|NCT00692978|Drug|Fluticasone Propionate_1.5|Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled
16293290|NCT00692978|Drug|Fluticasone Propionate_3|Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled
16293291|NCT00692978|Drug|Fluticasone Propionate_6|Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 6.0 microns, inhaled
16293292|NCT00692978|Drug|FP From Active 250 ug MDI Inhaler|Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler
16293293|NCT00692952|Drug|a novel Benzalkonium Chloride (BZK) contraceptive gel|insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.
16293294|NCT00692952|Drug|LELEMI® contraceptive gel containing 50mg nonoxynol-9|insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act
16293295|NCT00692939|Biological|autologous CD34-selected peripheral blood stem cells transplant|high-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)
16293296|NCT00692939|Drug|Alemtuzumab|Transplant conditioning
16293297|NCT00692939|Drug|ATG|Transplant conditioning
16293298|NCT00692939|Drug|Melphalan|Transplant conditioning
16293299|NCT00692939|Drug|Thiotepa|Transplant conditioning
16293300|NCT00692939|Drug|Rituximab|Transplant conditioning
16293301|NCT00692939|Drug|Cyclophosphamide|Mobilization
16293302|NCT00692939|Drug|G-CSF|Mobilization
16293303|NCT00692939|Drug|Mesna|Mobilization
16293304|NCT00692926|Biological|ALDHbr Umbilical Cord Blood Cells|ALDHbr sorted Umbilical Cord Blood Cells
16293305|NCT00692913|Drug|FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)|FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).
16293306|NCT00692913|Dietary Supplement|Calcium Supplement 500 mg|"Calcium supplied locally by the investigator (containing 500 mg
~calcium supplement) daily for 52 weeks (unless the patient's dietary intake of
~calcium exceeds 1000 mg per day)."
16293307|NCT00692913|Other|Referred-Care Model|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).
16293308|NCT00692900|Drug|intravenous docetaxel with intraperitoneal oxaliplatin|IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
16293309|NCT00692900|Drug|intravenous oxaliplatin with intraperitoneal docetaxel|IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
16293310|NCT00692887|Device|PHP - Preferential Hyperacuity Perimeter (Foresee)|computerized test
16293311|NCT00692848|Other|Procalcitonin dosage PCT-Q test (Brahms, Germany)|Procalcitonin result available to the attending physician
16293312|NCT00692835|Procedure|Total Thyroidectomy (Mini Video Assisted Thyroidectomy)|Immediate postoperative course of patients with Thyroidectomy
16293313|NCT00692835|Procedure|Total Thyroidectomy (Classic Thyroidectomy)|Immediate postoperative course of patients with Thyroidectomy
16293314|NCT00692796|Other|Pulmonary rehabilitation|Pulmonary rehabilitation is a multi-disciplinary program that includes exercise training, disease education, psychosocial education (e.g., stress management, coping with chronic illness) and nutrition education.
16293315|NCT00692770|Drug|Nexavar (Sorafenib, BAY43-9006)|Sorafenib 400 mg twice daily (BID)
16293316|NCT00692770|Drug|Placebo|Placebo 2 tablets twice daily (BID)
16293317|NCT00692757|Drug|Hypochlorous acid|Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray
16293318|NCT00692757|Drug|Iodopovidone|Iodopovidone
16293319|NCT00692731|Dietary Supplement|500 mL/day of a beverage providing approximately 625 mg catechins|Subjects were asked to consume 500 mL/day of a beverage providing approximately 625 mg catechins
16293320|NCT00692731|Other|Control beverage matched for energy and caffeine content|500 mL/day of a control beverage
16293321|NCT00692718|Drug|Epadel, Eicosapentaenoic acid|Epadel 900mg, 2 times a day, during hospitalization
16293322|NCT00692705|Drug|Radioligand (11C)AZD2995|Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.
16293323|NCT00692705|Drug|Radioligand (11C)AZD2184|Single dose of i.v solution. Once for AD patients respective healthy volunteers.
16293324|NCT00692692|Procedure|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
16293325|NCT00692692|Procedure|standard of care tissue expander breast reconstruction surgery after mastectomy|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
16293326|NCT00692653|Behavioral|P4|Tailored online decision support system for prostate cancer treatment decision making
16293327|NCT00692640|Drug|XL147 (SAR245408)|Gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing for 21 days/7 days off
16293328|NCT00692640|Drug|Erlotinib|Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
16293329|NCT00692614|Drug|triamcinolone acetonide|100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
16293330|NCT00692601|Dietary Supplement|Acute consumption of Capsiate Natura|10 capsules = 3 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. 3 active capsules containing 1 mg capsiate each and 7 placebo capsules.
16293372|NCT00692250|Drug|Colesevelam hydrochloride film-coated tablets (Cholestagel)|
16293332|NCT00692601|Dietary Supplement|Acute ingestion of identical placebo capsules|10 mg placebo = 0 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. Each capsule contains 1 mg capsiate.
16293333|NCT00692575|Behavioral|Problem-solving, education based telephone counseling|Caregivers are contacted every 2 weeks for 16-20 weeks after discharge of TBI survivor home. A caregiver support specialist provides telephone counseling based on a problem-solving, educational model.
16293334|NCT00692575|Other|No Intervention|The control group will receive standard of care, i.e., typical resources and/or supports offered to caregivers of persons with TBI.
16293335|NCT00692562|Procedure|simultaneous islet-kidney transplantation|
16293336|NCT00692549|Device|ultrasound|
16293337|NCT00692536|Behavioral|NNR (Nordic Nutrition Recommendations)|Diet with equal amounts of fat, protein and carbohydrates
16293338|NCT00692536|Behavioral|MPD (Modified paleolithic diet)|A diet high in protein and fat, but low in carbohydrates
16293339|NCT00692523|Other|Recreational therapy activities|Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
16293340|NCT00692523|Other|Nintendo Wii|The Nintendo Wii gaming system, released in 2005, introduced a new style of virtual reality by using a wireless controller that interacts with the player through a motion detection system. Nintendo Wii involves the incorporation of 3-dimensional accelerometer technology that can respond to changes in direction, speed, and acceleration, down to the most delicate movements. Specifically, the controllers use embedded acceleration sensors to enable players' wrist, arm, and hand movements to interact with the games. Tilt measurements allow users to move characters, while the accurate three-axis acceleration sensing easily transforms the controller into a virtual sword, gearshift, or musical instrument
16293341|NCT00692510|Drug|AZD3480|Capsule, oral, dose once daily, 7 days
16293342|NCT00692510|Drug|Placebo|Capsule, oral, dose once daily, 7 days
16293343|NCT00692510|Drug|Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)|"Cocktail mix which contains the following:
~CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)
~single dose of mix"
16293344|NCT00692497|Behavioral|one stop (Electronic standardised referrals and appointment bookings)|The one stop strategy is a set of interventions directed at GPs referring to the University Hospital. The interventions include: Guidelines for referral, standardised electronic referrals, booking for outpatient surgery and a patient information form.
16293345|NCT00692484|Drug|Chlorhexidine gluconate|Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
16293346|NCT00692484|Drug|Povidone iodine|Povidone iodine scrub and paint. Administer topically.
16293347|NCT00692471|Device|Actigraphy Watch (motion sensors) with light sensors - ActiWatch from Minimitter|Watch to be worn on wrist for 7 days (except in water) that will measure activity/movement.
16293348|NCT00692458|Drug|Comparator: odanacatib|odanacatib; 5mg oral, once daily for approximately 60 months.
16293349|NCT00692458|Drug|Comparator: placebo|placebo; oral, once daily for approximately 60 months
16293350|NCT00692445|Drug|TC-5214 + citalopram|TC-5214 (as TC-5214-23) will be provided as white, opaque, hard-gelatin capsules in strengths of 1, 2, and 4 mg.
16293351|NCT00692445|Drug|Placebo + citalopram|Placebo will be provided with exactly the same shape, size and appearance. Subjects will take 2, 4, or 8 mg of study drug (or matching placebo), divided BID.
16293352|NCT00692419|Behavioral|Symptom management nurse intervention|A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study
16293353|NCT00692419|Behavioral|Feedback intervention|Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider
16293354|NCT00692406|Behavioral|Smoking Abstinence|Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.
16293355|NCT00692393|Procedure|Hartmann intervention|sigmoid resection, peritoneal and rectal lavage, terminal stoma
16293356|NCT00692393|Procedure|Protected anastomosis resection|sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
16293357|NCT00692380|Radiation|Fractionated radiation therapy followed by chemotherapy|Increasing doses of radiation therapy
16293358|NCT00692367|Behavioral|Physical Activity|1. Physical activity group: Subjects will be progressed to 4-5 days per week, 30-45 min per session (120-180 min per week) of moderate intensity exercise. 2. Control (educational) group: Subjects will receive their usual care following surgery that in addition to their weight loss.
16293359|NCT00692354|Drug|CHR-2797 (tosedostat)|Drug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg
16293360|NCT00692341|Drug|AG-013736|Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
16293361|NCT00692341|Drug|AG-013736|Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
16293362|NCT00692341|Drug|AG-013736|Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
16293363|NCT00692328|Behavioral|Levodopa or acupuncture|Comparison of subject expectancy of receiving levodopa or acupuncture.
16293364|NCT00692315|Drug|Methylcobalamin (methylB12)|75 ug/Kg methylB12 every 3 days by subcutaneous injection
16293365|NCT00692302|Behavioral|SAFETY|Participants will receive a family-based cognitive behavioral therapy intervention called SAFETY for 12 weeks. The SAFETY intervention is an individually tailored intervention strategy that integrates (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources.
16293366|NCT00692302|Behavioral|Enhanced usual care|Enhanced usual care will include treatment as usual enhanced by study support.
16293367|NCT00692276|Device|Superion™ Interspinous Spacer|Implantation of interspinous process spacer to treat lumbar spinal stenosis
16293368|NCT00692276|Device|X-STOP® IPD® Device|Implantation of interspinous process spacer to treat lumbar spinal stenosis
16293375|NCT00692224|Drug|zinc gluconate|zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life
16293376|NCT00692224|Drug|placebo|placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug
16293377|NCT00692211|Other|Mailed fecal occult blood tests|Stool blood test
16293378|NCT00692211|Other|Mailed fecal immunochemical tests|Stool blood test
16293379|NCT00692198|Drug|Supplemental oxygen therapy|Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
16293380|NCT00692185|Drug|Olanzapine|Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
16293381|NCT00692185|Drug|Placebo|Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
16293382|NCT00692172|Drug|Alefacept|intramuscular injection (IM)
16293383|NCT00692159|Drug|TRC102 + pemetrexed|Oral TRC102 solution + IV pemetrexed
16293384|NCT00692146|Drug|AZD1386|Oral solution fixed dose (95 mg given orally on two occasions)
16293385|NCT00692146|Drug|Placebo|Oral solution fixed dose (95 mg given orally on two occasions)
16293386|NCT00692120|Dietary Supplement|Cholecalciferol (vitamin D3)|50,000 IU once monthly for 12 months
16293387|NCT00692120|Dietary Supplement|Ergocalciferol (vitamin D2)|oral capsule 50,000 IU once monthly for 12 months
16293388|NCT00692120|Dietary Supplement|Ergocalciferol (vitamin D2)|oral capsule 1600 IU once daily for 12 months
16293389|NCT00692120|Dietary Supplement|Cholecalciferol (vitamin D3)|oral capsule 1600 IU once daily for 12 months
16293390|NCT00692120|Dietary Supplement|Placebo|oral placebo capsule once daily for 12 months
16293391|NCT00692107|Radiation|Gray|68 Gy vs. 78 Gy
16293392|NCT00692107|Radiation|Gray|68 Gy vs. 78 Gy
16293393|NCT00692094|Biological|Melatonin|0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
16293394|NCT00692094|Biological|Melatonin|0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
16293395|NCT00692094|Biological|Melatonin|0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
16293396|NCT00692094|Biological|Melatonin|0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.
16293397|NCT00692081|Behavioral|Social competence training|8 group sessions multi-modal social competence training, 2-4 hours each, 2 trainers, 6-10 participants
16293398|NCT00692081|Behavioral|Special vocational training|as provided in German special centres for vocational training
16293399|NCT00692055|Drug|PN400|naproxen 375 mg / esomeprazole 20 mg
16293400|NCT00692055|Drug|Naproxen|naproxen 375 mg
16293401|NCT00692042|Drug|AZD1704|One dose, by mouth
16293402|NCT00692016|Drug|Naproxen sodium|Administered under fasting condition
16293403|NCT00692016|Drug|Naproxen sodium|Administered under fed condition
16293404|NCT00692003|Drug|Zonisamide|"25-400 mg capsules orally once daily in the evening.
~Maximum study duration of 28 weeks comprising:
~Baseline Period (Week-8/-4 to Week 0) no treatment
~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
~Down Titration Period (4 weeks)"
16293405|NCT00692003|Drug|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
~Maximum study duration of 28 weeks comprising:
~Baseline Period (Week-8/-4 to Week 0) no treatment
~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
~Down Titration Period (4 weeks)"
16293406|NCT00691990|Procedure|Total thyroidectomy|Comparison of the safety and cost-effectiveness of classic thyroidectomy with or without drains
16293407|NCT00691977|Radiation|Radiation Therapy followed by prostatectomy|Radiation Therapy
16293408|NCT00691964|Biological|ABT-874|SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
16293409|NCT00691964|Biological|etanercept|SQ injection 50 mg BIW
16293410|NCT00691964|Drug|placebo|SQ placebo injections for ABT-874 and etanercept
16293411|NCT00691951|Drug|budesonide and budesonide/formoterol|
16293412|NCT00691938|Drug|LBH589|
16293413|NCT00691938|Drug|Decitabine|
16293414|NCT00691912|Drug|liposomal Doxorubicin|20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
16293415|NCT00691912|Drug|Myocet / Paclitaxel|20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
16293416|NCT00691899|Drug|odanacatib|odanacatib; 5mg oral, once daily for Approximately 36 months.
16293417|NCT00691899|Drug|placebo (unspecified)|placebo; oral, once daily for Approximately 36 months
16293418|NCT00691886|Drug|dexmedetomidine hydrochloride|Dose of 0.4ug/kg/hr to 1.5ug/kg/hr to achieve a RASS score of -1 to-3 during the bronchoscopy procedure. Dexmedetomidine will infused a half hour before the proceudure is started and will continue throughout the procedure. Traditional sedatives (midazolam and or fentanyl) will be given prn.
16293419|NCT00691873|Drug|Placebo|placebo
16293420|NCT00691873|Drug|Xolair|Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
16293421|NCT00691860|Device|Mesh (Ultrapro ®)|In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy
16293422|NCT00691860|Procedure|Conventional sigmoid end colostomy|Patients receiving conventional sigmoid end colostomy, without mesh
16293423|NCT00691834|Biological|Intracoronary delivery of unfractionated bone marrow mononuclear cells|Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
16293424|NCT00691834|Biological|Placebo|Plasma and culture medium (10 ml)
16293425|NCT00691821|Other|Standard Dressings|Participants will receive standard dressings changes as needed. Different dressing types (e.g., silver, simple gauze, hydrogel, foam, creams, gels) will be used dependent on the type of the wound (e.g., dry, wet, and intermediate).
16293426|NCT00691821|Device|Negative Pressure Wound Therapy (Vacuum-Assisted Closure System [V.A.C.® Therapy™, KCI Medical Canada Inc., Mississauga, Ontario])|Participants will receive negative pressure wound therapy.
16293427|NCT00691808|Drug|LX6171 High Dose|A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
16293428|NCT00691808|Drug|LX6171 Low Dose|A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
16293429|NCT00691808|Drug|Placebo|Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
16293430|NCT00691795|Drug|Clonidine or fentanyl|After obtaining consent, the patients will be randomized into two groups using a random allocation table. At the onset of late stage breakthrough pain one arm of patients will receive a mixture of 75 mcg clonidine and 10 mg bupivacaine in 8 ml of volume and the second group will receive 75 mcg fentanyl and 10 mg bupivacaine in 8 ml of volume.
16293431|NCT00691782|Other|Survey of exercise practices|detailed questionnaire regarding the subject's race, income level; type(s), frequency, intensity, and amount of exercise; attitudes about exercise; hair style; hair care practices; attitudes about hair; hair and scalp health; and attitudes about exercise with regards to hair
16293432|NCT00691756|Procedure|Cold blood renal perfusion|Both kidneys receive intermitent perfusion with cold (4 degrees C) autologous blood during thoracoabdominal aortic aneurysm repair.
16293433|NCT00691756|Procedure|Cold crystalloid renal perfusion|Both kidneys receive intermittent perfusion with cold (4 degrees C) lactated Ringer's solution during thoracoabdominal aortic aneurysm repair. This is the standard renal perfusion technique in our practice.
16293434|NCT00691730|Other|laboratory biomarker analysis|Only sample collection, no other intervention - Correlative studies
16293435|NCT00691717|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Single administration by anterior juxtascleral depot
16293436|NCT00691717|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|Single administration by anterior juxtascleral depot
16293437|NCT00691717|Drug|Anecortave Acetate Sterile Suspension, 75 mg/mL|Single administration by anterior juxtascleral depot
16293438|NCT00691717|Other|Anecortave Acetate Vehicle|Single administration by anterior juxtascleral depot
16293439|NCT00691704|Drug|Lenalidomide Induction|Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
16293440|NCT00691704|Drug|Sequential Maintenance Therapy|"Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):
~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis
~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle
~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7
~Prednisone 60 mg /m2 po daily on Days 1-7 of a 28-day cycle
~Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21 of a 28 day cycle."
16293441|NCT00691691|Radiation|Stereotactic Body Radiation Therapy|Radiation Dose: 48 Gy in 4 fractions in 2 weeks. A minimum of 48 hours should separate each treatment (e.g. every Tuesday and Friday). The dose is prescribed to the marginal isodose (80-90%) that encompasses the entire target lesion (GTV). Treatment will be delivered using a linear accelerator. For verification of the accuracy of these external skin fiducial markers, 10 patients will also have implanted internal gold coil markers. The implantable gold coil markers will be implanted into the liver in the proximity of the target lesions via a percutaneous transhepatic route under fluoroscopy guidance.
16293442|NCT00691678|Drug|Chondroitin|400mg chondroitin TID for twenty-four weeks
16293443|NCT00691678|Drug|Glucosamine|500mg glucosamine TID for twenty-four weeks
16293444|NCT00691665|Drug|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
16293445|NCT00691665|Drug|Fluticasone Propionate Nasal Spray, 50 mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
16293446|NCT00691652|Biological|rituximab|Administered weekly times 4 weeks and then monthly during the study for up to 8 cycles and will be given on day 1 of clofarabine. A peripheral or central intravenous (IV) line will be established. The initial dose rate at the time of the first infusion should be 50/mg/hr for the first hour. If no toxicity is seen, the dose rate may be gradually escalated (50 mg/hr increments at 30 minute intervals) to a maximum of 300 mg/hr. If the first dose of rituximab is well tolerated, the starting flow rate for the administration of subsequent doses will be 100 mg/hr then gradually increased (100 mg/hr increments at 30 minute intervals) not to exceed 400 mg/hr.
16293447|NCT00691652|Drug|clofarabine|Phase 1 dosing: Initially, 3 patients will be enrolled into a dose level during the dose escalation portion. Level 1: 2mg fixed dose times 14 days for up to 8 cycles. Level 2: 4mg fixed dose times 14 days for up to 8 cycles. Level 3: 6mg fixed dose times 14 days for up to 8 cycles. Phase II dosing: The phase II dose of oral clofarabine will be determined from the phase 1.
16293448|NCT00691652|Genetic|DNA methylation analysis|We will use an HPLC assay developed by Yu et al31 to determine the DNA methylation (DMI) index in peripheral blood and bone marrow of patients entering this trial and after treatment with clofarabine and rituxan
16293449|NCT00691652|Genetic|gene expression analysis|Total RNA will be processed for determination of gene expression by microarray
16293450|NCT00691652|Genetic|microarray analysis|we will scan the microarray slides with an Axon scanner, and quantify data using the GeneSight software. Local background is subtracted and data points with no signal, high background, or spot asymmetry are eliminated. We will adjust genes with low expression and low signal intensity to a minimal raw value of 5: This avoids unwarranted mathematical distortions due to division by decimals << 1. After calculating the ratio of the Cy5 /Cy3 fluorescence signal intensity for each gene, we normalize the data relative to the mean intensity from all genes.
16293451|NCT00691652|Genetic|polymerase chain reaction|
16293496|NCT00691405|Drug|Placebo|Placebo inhalation solution QD
16293497|NCT00691392|Drug|Linezolid|Linezolid 600 mg po daily for 16 weeks (112 doses) - over-encapsulated
16293452|NCT00691652|Other|high performance liquid chromatography|Fifteen µg of DNA will be sonicated for 60 seconds on ice into 200 bp-1000 bp fragments. Samples are then denatured at 1000C for 5 minutes and cooled on ice to prevent re-annealing. Sixty units of nuclease S1 (Invitrogen) and 112.5 mu of snake venom phosphodiesterase I (Sigma) in 12 µl of S1 dilution buffer is then added to the samples and incubated at 370C for 18 hours. Samples are reheated to 1000C for 5 minutes, snap cooled again on ice, and another sixty units of nuclease S1 and 112.5 mu of snake venom phosphodiesterase I are added and incubated at 370C for another 4 to 6 hours. The pH of each sample was raised to 8.5 with 0.5 M Tris, pH 10. Two and a half units of alkaline phosphatase (Sigma) are added and incubated for 2 additional hours at 370C. One hundred µl of 0.05M potassium phosphate, pH 7 is added to final samples before 50 µl of the clear supernatant is injected into the reverse-phase high performance liquid chromatography (HPLC).
16293453|NCT00691652|Other|laboratory biomarker analysis|50 µl of the clear supernatant is injected into the reverse-phase high performance liquid chromatography (HPLC).
16293454|NCT00691639|Other|Blood Collection Only|Blood Collection Only
16293455|NCT00691626|Behavioral|CBT for Insomnia plus Imagery Rehearsal|patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress
16293456|NCT00691626|Behavioral|CBT for Insomnia plus psychoeducation|patients receive standard CBT for insomnia combined with psychoeducation
16293457|NCT00691613|Drug|Epoetin alpha|The dosage (60.000 I/U Epoetin alpha) will be diluted in 10 ml of 0.9% sodium chloride solution and injected in a single dose intravenously in the dominant forearm (the non-dominant forearm will be used as ischemic model).
16293458|NCT00691613|Drug|NaCl|0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.
16293459|NCT00691600|Drug|oral trimethoprim/sulfamethoxazole|80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
16293460|NCT00691600|Drug|Placebo|Placebo caps or suspension every 12 hours for 10 days
16293461|NCT00691587|Biological|KB001|Single low-dose, administered intravenously
16293462|NCT00691587|Biological|KB001|Single high-dose, administered intravenously
16293463|NCT00691587|Biological|Placebo|Placebo single-dose, administered intravenously
16293464|NCT00691574|Dietary Supplement|Melatonin|up to 3 mg, daily, for up to 1 year
16293465|NCT00691574|Device|Enviro-light artificial light box|Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA.
16293466|NCT00691561|Behavioral|Project ABLE|Participants will receive HIV counseling and testing. Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks. The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior. The factors include identity, stigma, connections to community, and situation factors.
16293467|NCT00691548|Drug|Cetuximab-Zr. 89|"Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with 89Zr (60 MBq, 2.5mg) on day 0.
~On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr (60 MBq, 2.5mg), will be given.
~Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr (120MBq, 5mg)."
16293468|NCT00691522|Drug|Xerecept|
16293469|NCT00691509|Genetic|gene expression analysis|
16293470|NCT00691509|Genetic|polymorphism analysis|
16293471|NCT00691509|Other|high performance liquid chromatography|
16293472|NCT00691509|Other|laboratory biomarker analysis|
16293473|NCT00691509|Other|mass spectrometry|
16293474|NCT00691509|Other|questionnaire administration|
16293475|NCT00691496|Behavioral|Behavioral intervention to reduce sexual risk among African-American men who have sex with men|5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal
16293476|NCT00691483|Drug|placebo|placebo tablet taken orally twice daily for 12 weeks
16293477|NCT00691483|Drug|varenicline|varenicline tablets, 1 mg taken orally twice daily for 12 weeks
16293478|NCT00691470|Drug|ATI-5923|Dose Adjusted based on INR.
16293479|NCT00691470|Drug|Coumadin (warfarin)|Dose adjusted based on INR.
16293480|NCT00691457|Device|Opti-Free contact lens solution|Solution
16293481|NCT00691457|Device|ReNu Multiplus contact lens solution|Solution
16293482|NCT00691457|Device|Clear Care contact lens solution|Solution
16293483|NCT00691444|Dietary Supplement|Melatonin|"Subjects will be given up to 0.5 mg daily.
~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
16293484|NCT00691444|Dietary Supplement|Melatonin|"Subjects will be given up to 10 mg daily.
~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
16293485|NCT00691444|Biological|Melatonin|"Subjects will be given up to 20 mg daily.
~0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns)."
16293486|NCT00691431|Device|LASIK|
16293487|NCT00691418|Dietary Supplement|docosahexaenoic acid (DHA)|600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
16293488|NCT00691418|Dietary Supplement|placebo|placebo once per day starting at 22-24 weeks gestation until delivery.
16293489|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 5 mcg BID
16293490|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 15 mcg BID
16293491|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 25 mcg BID
16293492|NCT00691405|Drug|Placebo|Placebo inhalation solution BID
16293493|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 15 mcg QD
16293494|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 25 mcg QD
16293495|NCT00691405|Drug|Arformoterol tartrate inhalation solution|Arformoterol 50 mcg QD
16293498|NCT00691392|Drug|Microcrystalline Methylcellulose - Placebo|The placebo will be over-encapsulated microcrystalline methylcellulose
16293499|NCT00691379|Drug|Carboplatin|Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
16293500|NCT00691379|Drug|Bevacizumab|Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
16293501|NCT00691379|Drug|Paclitaxel|Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
16293502|NCT00691327|Device|Natrelle(TM) Silicone-Filled Breast Implants|Breast implant surgery
16293503|NCT00691314|Device|Stent implantation (Wingspan, Coroflex, and TiTAN2)|"Stent Implantation:
~Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stent system and Coroflex Blue - Coronary Stent System; TiTAN2 Bio-active coating stent
~Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .
~Arms: 1"
16293504|NCT00691314|Drug|Standard medical treatment|Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide)
16293505|NCT00691301|Drug|cisplatin|Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
16293506|NCT00691301|Drug|pemetrexed disodium|
16293507|NCT00691288|Drug|Omega Pure followed by placebo|Subjects in this arm will begin the study on active capsules (containing Omega Pure). Subjects in the 5-11 age group will take 2 capsules containing 500mg EPA/DHA twice daily for 12 weeks. Subjects in the 12-18 age group will take 2 capsules containing 1.0g EPA/DHA twice daily, also for a period of 12 weeks. Both age groups will then be switched to the placebo capsules containing citrus-flavoured soybean and corn oil, identical in appearance to the active agent, to be taken on an identical regimen to the active pills, for a period of 12 weeks.
16293508|NCT00691288|Drug|Placebo followed by Omega Pure|Patients assigned to this arm of the study will begin on placebo followed by Omega Pure (identical dose and regimen as arm 1), also for a period of 12 weeks each.
16293509|NCT00691275|Drug|Ondansetron|
16293510|NCT00691275|Drug|Saline|
16293511|NCT00691262|Drug|tacrolimus ointment|transdermal
16293512|NCT00691249|Dietary Supplement|Resistant Starch Type 4-Raw|Low Dose- 70g bar
16293513|NCT00691249|Dietary Supplement|Resistant Starch Type 4-Raw|High Dose- 100g bar
16293514|NCT00691249|Dietary Supplement|Resistant Starch Type 4-Cooked|Low Dose- 70g bar
16293515|NCT00691249|Dietary Supplement|Resistant Starch Type 4-Cooked|High dose: 100g bar
16293516|NCT00691249|Dietary Supplement|Shredded Wheat|70g bar
16293517|NCT00691236|Drug|Zoledronic acid|4mg IV 3 weekly for 6 doses
16293518|NCT00691236|Drug|Standard chemotherapy|Adriamycin + Cisplatinum and Ifosfamide
16293519|NCT00691210|Drug|Vorinostat|"Dose escalation scheme (400 mg)
~Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells."
16293520|NCT00691210|Drug|Niacinamide|"Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
~Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer."
16293521|NCT00691210|Drug|Etoposide|"Dose escalation scheme (0, 25, 50, 100 mg/m2)
~Etoposide is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. This medication is classified as a plant alkaloid and topoisomerase II inhibitor."
16293522|NCT00691197|Device|Carboxymethylcellulose sodium and Glycerin|Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
16293523|NCT00691197|Device|Carboxymethylcellulose sodium|Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
16293524|NCT00691184|Drug|Placebo|0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
16293525|NCT00691184|Drug|Terbinafine Hydrochloride|10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
16293526|NCT00691184|Drug|Terbinafine Hydrochloride|1% Terbinafine Hydrochloride Cream, twice a day for 7 days.
16293527|NCT00691184|Drug|Terbinafine|Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.
16293528|NCT00691158|Drug|Pramlintide (Amylin)|4.7 mls of Amylin 15mcg/ml IV bolus.
16293529|NCT00691158|Drug|Placebo (Normal Saline)|4.7 mls normal saline IV bolus x1
16293530|NCT00691158|Drug|2 Metreleptin|Receive .06mg/kg of metreleptin IV bolus x1
16293531|NCT00691158|Drug|Leptin plus Pramlintide|receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.
16293532|NCT00691145|Drug|tacrolimus ointment|transdermal
16293533|NCT00691132|Drug|phenethyl isothiocyanate|Given orally
16293534|NCT00691132|Other|placebo|Given orally
16293535|NCT00691119|Behavioral|Relaxation and Visualization Therapy|Twenty minutes of facilitated relaxation and visualization therapy five days a week for six weeks. Self practice of 20 minutes per day for the next six weeks.
16293536|NCT00691119|Other|Health education|Facilitated health education sessions, twenty minutes, five times a week for six weeks.
16293537|NCT00691093|Drug|fesoterodine|4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
16293538|NCT00691067|Drug|mifepristone|200 mg po per day x 6 weeks
16293539|NCT00691067|Drug|Placebos|placebo
16293540|NCT00691054|Drug|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
16293647|NCT00690300|Drug|Oxaliplatin|80 mg/m2 IV on day 2 of each 22 day cycle
16293541|NCT00691041|Behavioral|Unity in Diversity|HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network
16293542|NCT00691028|Drug|TA-650 3 mg/kg|3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.
16293543|NCT00691028|Drug|TA-650 6 mg/kg|3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.
16293544|NCT00691028|Drug|TA-650 10 mg/kg|3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.
16293545|NCT00691015|Biological|rituximab|Given IV
16293546|NCT00691015|Drug|busulfan|Given IV
16293547|NCT00691015|Drug|carmustine|Given IV
16293548|NCT00691015|Drug|cyclophosphamide|Given IV
16293549|NCT00691015|Drug|cytarabine|Given IV
16293550|NCT00691015|Drug|etoposide|Given IV
16293551|NCT00691015|Drug|fludarabine phosphate|Given IV
16293552|NCT00691015|Drug|melphalan|Given IV
16293553|NCT00691015|Radiation|total body irradiation (TBI)|Given once or twice daily
16293554|NCT00691015|Drug|anti-thymocyte globulin IV|Given IV
16293555|NCT00691002|Drug|Calcipotriol plus hydrocortisone (LEO 80190)|Once daily application
16293556|NCT00691002|Drug|LEO 80190 Vehicle|
16293557|NCT00691002|Drug|Hydrocortisone|
16293558|NCT00691002|Drug|Calcipotriol|
16293559|NCT00690976|Behavioral|Proyecto SOL|Group intervention
16293560|NCT00690976|Behavioral|HCT|Offer of HIV counseling and testing
16293561|NCT00690963|Procedure|Radiotherapy|Dose excalation based on normal tissue toxicity using 5 dose bins ranging from 56.8 Gy/ 27 fractions to 67.3 Gy in 27 fractions.
16293562|NCT00690950|Drug|Dutasteride|0.5mg capsule, taken once daily for 12 months
16293563|NCT00690937|Drug|Enteric coated sevelamer|Drug treatment
16293564|NCT00690937|Drug|Enteric coated sevelamer|Drug treatment
16293565|NCT00690937|Drug|Colesevelam Cholestagel|Drug comparator
16293566|NCT00690937|Drug|Placebo|Placebo
16293567|NCT00690937|Drug|Placebo|Placebo
16293568|NCT00690924|Drug|calcitriol|Oral
16293569|NCT00690924|Other|laboratory biomarker analysis|Correlative Study
16293570|NCT00690924|Other|pharmacological study|Correlative Study
16293571|NCT00690911|Drug|adalimumab|40mg dose subcutaneously using sterile technique. The site research staff will instruct and supervise subjects or a designee or nurse on proper injection technique during site visit evaluations. Subjects or a reliable designee will administer injectable study drug at home in between site visit evaluations.
16293572|NCT00690898|Drug|Lanreotide autogel 120 mg|12 months
16293573|NCT00690885|Drug|interferon-alpha lozenges|150 IU natural human interferon-alpha lozenges for oral dissolution given 3 times per day for 4 weeks
16293574|NCT00690885|Drug|placebo lozenges|matching placebo lozenges
16293575|NCT00690872|Biological|autologous Epstein-Barr virus-specific cytotoxic T lymphocytes|
16293576|NCT00690872|Drug|carboplatin|
16293577|NCT00690872|Drug|gemcitabine hydrochloride|
16293578|NCT00690872|Genetic|polymerase chain reaction|
16293579|NCT00690872|Other|fluorescence activated cell sorting|
16293580|NCT00690872|Other|immunoenzyme technique|
16293581|NCT00690846|Drug|adalimumab|40 mg weekly adalimumab injection.
16293582|NCT00690833|Drug|topical desonide hydrogel 0.05%|apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
16293583|NCT00690820|Drug|Pancrelipase Delayed Release|12,000 unit Capsules, dosed individually based on fat intake.
16293584|NCT00690820|Drug|Placebo Comparator|Placebo
16293585|NCT00690807|Drug|PH-10|PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.
16293586|NCT00690794|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.
16293587|NCT00690794|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.
16293588|NCT00690781|Dietary Supplement|Pulse casein feeding during energy restriction|Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being casein. In addition, a pulse protein feeding pattern is used (8% protein in the morning, 80% for lunch, 4% at 1600 h and 8% in the evening).
16293589|NCT00690781|Dietary Supplement|Spread casein feeding during energy restriction|Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being casein. In addition, a spread protein feeding pattern is used (25% of protein at each of the four meals of the day).
16293590|NCT00690781|Dietary Supplement|Pulse milk soluble protein feeding during energy restriction|Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being milk soluble proteins. In addition, a pulse protein feeding pattern is used (8% protein in the morning, 80% for lunch, 4% at 1600 h and 8% in the evening).
16293591|NCT00690781|Dietary Supplement|Spread milk soluble protein feeding during energy restriction|Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being milk soluble proteins. In addition, a spread protein feeding pattern is used (25% of protein at each of the four meals of the day).
16293592|NCT00690768|Drug|Bevacizumab|Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
16293593|NCT00690768|Procedure|pars plana vitrectomy|pars plana vitrectomy 3 weeks after baseline
16293648|NCT00690287|Drug|AZD6370|Oral single doses a+b+c, o.d., suspension
16293594|NCT00690729|Behavioral|Cognitive Behavioral Bibliotherapy|Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
16293595|NCT00690729|Behavioral|Cognitive Behavioral Therapy|Therapist-directed exposure and response prevention
16293596|NCT00690716|Drug|Nasal CO2|Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
16293597|NCT00690716|Drug|Inactive Placebo|Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
16293598|NCT00690703|Device|RF ablation (Rita Medical Systems Model 1500x)|computed tomography-guided RF ablation with an expandable electrode needle
16293599|NCT00690690|Behavioral|Video (group-delivered video-based intervention)|group-delivered video-based intervention
16293600|NCT00690690|Behavioral|HCT|Offer of HIV counseling and testing
16293601|NCT00690677|Drug|LBH589|"LBH589 will be administered orally at a dose of 30mg (1 - 20mg capsule and 2 - 5g capsules) on Monday, Wednesday and Friday of each week (three times a week). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.
~The LBH589 capsules should be swallowed by mouth with a glass of water in the morning. The recommended way to take LBH589 is after not eating for at least 2 hours. You should also not eat for another 2 hours after taking your LBH589 capsules. The daily dose of LBH589 should be taken at approximately the same time each day. You should avoid eating grapefruit, seville oranges, or drinking grapefruit or seville orange juice during the study."
16293602|NCT00690651|Procedure|Early mobilization|pt to get out of bed and mobilize with physiotherapist within 24 hours of surgery. they will be allowed toilet privileges and will go home when safe (as per medical staff and allied health)
16293603|NCT00690651|Procedure|Standard mobilization|this group will rest in bed with their leg elevated above their heart for 48 hours post surgery to ankle fracture and will then mobilize with physiotherapist with aim to discharge home.
16293604|NCT00690638|Drug|PHX1149T|200 mg
16293605|NCT00690638|Drug|PHX1149T|400 mg
16293606|NCT00690638|Drug|Placebo|Placebo
16293607|NCT00690625|Drug|MyoRx Cream (6% Omega 3 Fatty Acid)|1/2 teaspoon 3 times per day for 30 days.
16293608|NCT00690625|Drug|Placebo cream, no Omega 3 fatty acid|Placebo cream, no Omega 3 fatty acid
16293609|NCT00690612|Drug|candesartan cilexetil|0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
16293610|NCT00690573|Biological|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
16293611|NCT00690560|Biological|rituximab|
16293612|NCT00690560|Drug|cyclophosphamide|
16293613|NCT00690560|Drug|doxorubicin hydrochloride|
16293614|NCT00690560|Drug|prednisone|
16293615|NCT00690560|Drug|vincristine sulfate|
16293616|NCT00690560|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16293617|NCT00690547|Other|muscle activation|activation of the muscle quadriceps femoris
16293618|NCT00690534|Drug|Insulin Regular|insulin, 0.2 mU/kg/min for 3 hours
16293619|NCT00690534|Drug|L-NMMA|variable rate for 3 hours
16293620|NCT00690534|Drug|Sodium Nitroprusside|variable rate for 3 hours
16293621|NCT00690534|Other|mixed meal|mixed meal
16293622|NCT00690521|Drug|metolazone or hydrochlorothiazide|The specific dose of hydrochlorothiazide will be determined by the individual's creatinine clearance. A creatinine clearance of 30-50 mL/min will indicate a dose of 50 mg per day. A creatinine clearance of > 50 mL/min will indicate a dose of 25 mg per day.5 If metolazone is added to their regimen, the specific dose will be determined using the equivalence ratio of 5 mg metolazone to 50 mg hydrochlorothiazide.
16293623|NCT00690508|Procedure|Supra-Sternal Tube-Tip Palpation (SSTTP)|The supra-sternal palpation of the tube after tracheal intubation.
16293624|NCT00690495|Drug|Propofol|Propofol (drug), intravenous, induction of anesthesia
16293625|NCT00690495|Drug|Propofol 1%|Propofol (drug), intravenous, induction of anesthesia
16293626|NCT00690482|Drug|AZD1981|Oral tablet, twice daily
16293627|NCT00690482|Drug|Placebo|Placebo Oral tablet, twice daily
16293628|NCT00690469|Other|Laboratory Biomarker Analysis|Correlative studies
16293629|NCT00690469|Other|Questionnaire Administration|Ancillary studies
16293630|NCT00690456|Drug|Rimonabant|Tablet, oral administration
16293631|NCT00690456|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16293632|NCT00690456|Drug|Metformin|Metformin continued at stable dose as background therapy
16293633|NCT00690443|Drug|Atorvastatin|atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
16293634|NCT00690443|Drug|AEGR-733|2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
16293635|NCT00690430|Drug|Pasireotide|Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed
16293636|NCT00690430|Drug|Octreotide|Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed
16293637|NCT00690417|Dietary Supplement|Cholecalciferol (vitamin D3)|low calorie (~60 calories) cookie-like disc containing 2,500 IU of vitamin D3, taken by mouth daily for 4 months
16293638|NCT00690404|Drug|AZD2066|single oral dose
16293639|NCT00690378|Drug|NXL104/ceftazidime|125mg/500mg TID
16293640|NCT00690378|Drug|Imipenem/Cilastatin|4 x daily
16293641|NCT00690352|Behavioral|Specialized Substance Abuse Supervision (SSAS)|Six months participation in SSAS which may include cognitive behavioral therapy (CBT) in groups; use of incentives, positive reinforcement, and/or motivational interviewing.
16293642|NCT00690339|Device|Style 410 Silicone-Filled Breast Implants|Breast Implant Surgery
16293643|NCT00690326|Behavioral|Behavioral change communication to promote physical activity|"treatment type: behavioral (lifestyle counseling)
~treatment name: behavioral change communication to promote physical activity"
16293644|NCT00690326|Behavioral|Behavioral change communication to promote physical activity|"Arm B given placebo comparator ie pamphlet
~Audiovisual module Physical activity frequency questionnaire"
16293645|NCT00690313|Drug|Vigamox|eye drops 3 times day either 1 or 3 days prior to intravitreal injection
16293646|NCT00690300|Drug|Docetaxel|75 mg/m2 IV on day 1 of each 22 day cycle
16293649|NCT00690287|Drug|AZD6370|Oral single dose, o.d., b.i.d. and q.i.d., suspension
16293650|NCT00690287|Drug|Placebo|Placebo
16293651|NCT00690274|Drug|BF2.649|up to 20mg per day
16293652|NCT00690274|Drug|Placebo|up to 20mg per day
16293653|NCT00690235|Drug|Pramlintide|180mg subcutaneous injections, twice daily
16293654|NCT00690235|Drug|Placebo|180mg subcutaneous injections, twice daily
16293655|NCT00690222|Procedure|Intracameral injection of mydriatic agent|A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery
16293656|NCT00690209|Procedure|Autologous bone marrow derived stem cells myocardial transplantation|
16293657|NCT00690196|Behavioral|Tai Chi Chih|"Tai Chi Chih (TCC) employs meditation through movement as a means of helping breast cancer survivors cope with fatigue, perceived physical limitations, and negative emotional states which are commonly associated with insomnia. In groups of 7-8, subjects will learn to perform 20 movements under the guidance of expert TCC teacher (K. Hollister, certified instructor) who will oversee treatment sessions throughout the 12 week treatment, consistent with our preliminary studies (9). Sessions will be taught over 120 minutes with 90 minutes of active TCC, 20 minutes of warm-up (e.g., stretching, breathing),10 minutes of cool down. Sessions will be mainly given in the late afternoon at 16:00 h. Thus, the TCC will be given once a week per week for a total of 120 minutes, similar in total time allocation with Cognitive Behavioral Therapy. The final week of treatment will include the development of a TCC adherence plan to ensure continuity of practice and skill maintenance during follow-up."
16293658|NCT00690196|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) for insomnia will be supervised by a Ph.D. level psychologist, with specialty training in behavior therapy and behavioral medicine. The CBT sessions will be held once a week for 120 minutes (each session) over the 12-week treatment period, identical to the time schedule which was to be used for health education. Treatment will be given in small groups of 7-8 subjects. The content of the intervention will be organized around a series of modules that will be presented to patients in manualized form. For each session, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
16293659|NCT00690170|Drug|Ketamine|Ketamine: 0.23 mg/kg bolus over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes
16293660|NCT00690170|Drug|Nicotine|Nicotine: 13.5 µg/kg given over 10 min (1.35 µg/min/kg),IV (in the arm) followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg) Placebo: Normal saline (sodium chloride 0.9%)IV (in the arm)
16293661|NCT00690170|Drug|Placebo|Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes
16293662|NCT00690170|Drug|Ketamine and Nicotine|"0.23 mg/kg of ketamine bolus IV (in the arm) over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes.
~13.5 µg/kg of nicotineIV (in the arm) given over 10 min (1.35 µg/min/kg), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg)"
16293663|NCT00690144|Device|High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).|Critical care training using high-fidelity simulation. The case scenarios were simulated by a high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
16293664|NCT00690131|Behavioral|BTSCS|BTSCS includes: (1) A behavioral group emphasizing motivational enhancement, skills training, education, and relapse prevention; (2) Contingency management with financial incentives to reinforce reductions in smoking; (3) Supported use of Bupropion or nicotine replacement therapy that is integrated with clients' psychiatric care in participants who are interested; and (4) Smoking cessation care coordination to increase treatment engagement and retention.
16293665|NCT00690118|Drug|pioglitazone|45 mg/day, 18 months
16293666|NCT00690118|Drug|placebo|once daily, 18 months
16293667|NCT00690105|Drug|tacrolimus 0.1%|ointment
16293668|NCT00690105|Drug|fluticasone 0.005 %|ointment
16293669|NCT00690092|Biological|Spherule-derived coccidioidin|1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.
16293670|NCT00690079|Drug|AZD1386|Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L
16293671|NCT00690079|Drug|Placebo|Oral admin. of doses at 11 days through a 12 days period.
16293672|NCT00690066|Drug|PROCHYMAL®|Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
16293673|NCT00690066|Drug|Placebo|Intravenous infusion of excipients of PROCHYMAL®
16293674|NCT00690053|Procedure|Injection of HX-4|In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)
16293675|NCT00690040|Device|Foley catheter|Single balloon catheter
16293676|NCT00690040|Device|Atad catheter|Double balloon catheter
16293677|NCT00690027|Procedure|Emergency portacaval shunt|
16293678|NCT00690027|Procedure|Emergency and long-term endoscopic sclerotherapy|
16293679|NCT00690014|Drug|probenecid|500 mg q 6 hrs
16293680|NCT00689988|Behavioral|speech-language therapy with AAC intervention|speech-language intervention in weekly 40-minutes sessions, without the presence of parents or caregivers, and 5 to 10-minutes to parents training and orientation
16293681|NCT00689975|Behavioral|behavioral dietary intervention|
16293682|NCT00689975|Behavioral|exercise intervention|
16293683|NCT00689975|Other|counseling intervention|
16293684|NCT00689975|Other|flow cytometry|
16293685|NCT00689975|Other|immunoenzyme technique|
16293686|NCT00689975|Other|laboratory biomarker analysis|
16293687|NCT00689975|Procedure|complementary or alternative medicine procedure|
16293688|NCT00689975|Procedure|standard follow-up care|
16293689|NCT00689962|Device|Linvatec 4.5 mm Smart Screw|Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
16293690|NCT00689962|Device|Synthes 4.0 mm steel screw|Standard steel screw use to surgically fix the foot's Lisfranc ligaments.
16293691|NCT00689949|Dietary Supplement|folic acid|0.4 mg of folic acid per day
16293734|NCT00689741|Biological|Cervarix|3 doses of IM injection
16293692|NCT00689936|Drug|Lenalidomide and low-dose dexamethasone|"Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD.
~Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression"
16293693|NCT00689936|Drug|Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles|"lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles.
~Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles"
16293694|NCT00689936|Drug|Melphalan, Prednisone and Thalidomide|Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
16293695|NCT00689897|Procedure|acupuncture, Deqi|Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.
16293696|NCT00689897|Procedure|acupuncture, Non-Deqi|After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
16293697|NCT00689884|Drug|Pegfilgrastim|Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).
16293698|NCT00689871|Device|Natrelle(TM) Silicone-Filled Breast Implants|Breast implant surgery
16293699|NCT00689858|Drug|Cilostazol, Ginkgo biloba and placebo|dosing time
16293700|NCT00689845|Biological|bleomycin sulfate|Given IV
16293701|NCT00689845|Biological|filgrastim|Given subcutaneously
16293702|NCT00689845|Biological|rituximab|given IV
16293703|NCT00689845|Drug|cyclophosphamide|Given IV
16293704|NCT00689845|Drug|cytarabine|Given subcutaneously
16293705|NCT00689845|Drug|doxorubicin hydrochloride|Given IV
16293706|NCT00689845|Drug|etoposide phosphate|Given IV
16293707|NCT00689845|Drug|ifosfamide|Given IV
16293708|NCT00689845|Drug|methotrexate|Given IV
16293709|NCT00689845|Drug|prednisolone|Given orally
16293710|NCT00689845|Drug|prednisone|Given orally
16293711|NCT00689845|Drug|vincristine sulfate|Given IV
16293712|NCT00689845|Drug|vindesine|Given IV
16293713|NCT00689832|Drug|Tacrolimus 0.03%|ointment
16293714|NCT00689832|Drug|Fluticasone 0.005%|ointment
16293715|NCT00689819|Behavioral|Exercise|Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293716|NCT00689819|Behavioral|Exercise|Blood pressure (BP) target will be < 120/80 mmHg. BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293717|NCT00689819|Behavioral|Weight Loss|Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293718|NCT00689819|Behavioral|Low Sodium Diet|Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293735|NCT00689741|Biological|placebo|3 doses of IM injection of Al(OH)3 placebo
16293736|NCT00689728|Biological|LY2127399|LY2127399 will be administered as a single IV infusion over 30 minutes.
16293737|NCT00689728|Drug|Placebo|Placebo will be administered as a single IV infusion over 30 minutes.
16293780|NCT00689390|Biological|Narlaprevir|In previous treatment studies, narlaprevir was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390).
16293827|NCT00689091|Device|Electronic MAC alert|Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.
16293719|NCT00689819|Behavioral|Smoking Cessation|Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293720|NCT00689819|Drug|Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)|Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293721|NCT00689819|Behavioral|Weight Loss|Blood pressure (BP) target will be < 120/80 mmHg. BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293722|NCT00689819|Behavioral|Low Sodium Diet|Blood pressure (BP) target will be < 120/80 mmHg. BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293723|NCT00689819|Behavioral|Smoking Cessation|Blood pressure (BP) target will be < 120/80 mmHg. BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293724|NCT00689819|Drug|Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)|Blood pressure (BP) target will be < 120/80 mmHg. BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.
16293725|NCT00689806|Drug|Lovastatin|Lovastatin 20 mg extended release (or placebo) by mouth once daily for weeks 1-4. Liver function test will be checked at week 4 follow up visit. If LFTs are not > 3 times the upper limit of normal, then the subject will have the dose of extended release lovastatin increased to 60 mg once a day for weeks 4-12
16293726|NCT00689806|Drug|Placebo|Placebo by mouth once daily for weeks 1-4.
16293727|NCT00689793|Drug|Ferrous sulphate|"Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue ( Fatigue Severity Scale). We will also check depression and anxiety symptoms ( Prime MD ) and health survey ( SF-12 ). An evaluation of the menstruation ( Pictorial Bleeding Assessment Chart  of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes."
16293728|NCT00689793|Drug|Placebo|"Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue ( Fatigue Severity Scale). We will also check depression and anxiety symptoms ( Prime MD ) and health survey ( SF-12 ). An evaluation of the menstruation ( Pictorial Bleeding Assessment Chart  of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes."
16293729|NCT00689780|Drug|AZD1940|Oral solution Multiple ascending dose given orally once daily at day 1-12
16293730|NCT00689780|Drug|Midazolam|Oral solution given orally once daily on day -1 and day 14
16293731|NCT00689767|Device|CINATRA™ Coronary Stent System|Bare metal cobalt chromium stent implantation
16293732|NCT00689767|Device|CINATRA™ ISA 247 Coated Coronary Stent System|Drug coated cobalt chromium stent implantation
16293733|NCT00689754|Procedure|nasogastric tube placement|standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline
16293738|NCT00689715|Procedure|Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection|A curvilinear-array echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration, ethanol lavage and paclitaxel injection. The maximum possible volume of cyst fluid was aspirated, and the needle tip was carefully maintained inside the cyst to avoid parenchymal injury. Ethanol was injected into the collapsed cyst until the original shape was restored, and a lavage was then performed for 3-5 minutes. Pure ethanol (99%) was used for all patients except the first 2 in whom 88% ethanol was used. After reaspiration of the injected ethanol, the cyst cavity was injected with a solution containing 3 mg/mL paclitaxel and the needle then carefully retracted. The high viscosity of paclitaxel necessitated dilution in 0.9% normal saline for administration via a 22G needle. The volume of the paclitaxel solution administered was the same as the volume of the cyst fluid aspirated.
16293739|NCT00689702|Drug|cetuximab, capecitabine|"Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50).
~Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy.
~Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks."
16293740|NCT00689689|Device|Fully coated Prodigy stem|Total hip arthroplasty with fully coated Prodigy stem
16293741|NCT00689689|Device|Cemented Endurance Stem|total hip arthroplasty with cemented endurance stem
16293742|NCT00689663|Procedure|Laparoscopic cholecystectomy|Randomized to three arm.
16293743|NCT00689650|Device|1540 nm fractional laser|
16293744|NCT00689637|Drug|AZD3480|AZD3480 capsules qd, 12 days
16293745|NCT00689637|Drug|Placebo|Placebo capsules qd, 12 days
16293746|NCT00689637|Drug|Warfarin|Warfarin: single dose on day 6
16293747|NCT00689624|Drug|Irinotecan|Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
16293748|NCT00689624|Drug|Leukovorin|Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
16293749|NCT00689624|Drug|Oxaliplatin|Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
16293750|NCT00689624|Drug|5-FLUOROURACIL|5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
16293751|NCT00689624|Drug|Cetuximab|Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy
16293752|NCT00689611|Drug|Bupropion HCl ER|150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks
16293753|NCT00689611|Drug|Placebo|Placebo
16293754|NCT00689598|Drug|Spironolactone|25 mg po qd 25 mg po bid
16293755|NCT00689598|Drug|Placebo|Spironolactone 25 mg po qd
16293756|NCT00689585|Drug|Placebo|250mg matching placebo capsules
16293757|NCT00689585|Drug|Ethosuximide|500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period.
16293758|NCT00689572|Drug|Ondansetron|4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
16293759|NCT00689572|Drug|Placebo|twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
16293760|NCT00689559|Drug|AZD3480|AZD3480 capsules qd, oral, 22 days
16293761|NCT00689559|Drug|Placebo|Placebo qd, 12 days
16293762|NCT00689559|Drug|Aripiprazole|single dose on day 5
16293763|NCT00689520|Drug|tinzaparin|tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
16293764|NCT00689520|Drug|acenocoumarol|tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
16293765|NCT00689507|Biological|LY2127399|monoclonal antibody
16293766|NCT00689494|Other|Nanopaz contraception device|levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method
16293767|NCT00689481|Drug|U0267 Foam|All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
16293768|NCT00689481|Drug|Vehicle foam|All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
16293769|NCT00689468|Procedure|Cranial osteopathic manipulative treatment.|A series of five cranial osteopathic manipulative treatment sessions scheduled over three months, and provided by osteopathic physicians whose practices are limited to osteopathic manipulative treatment. Treatment modalities were limited to cranial osteopathy, balanced membranous/ligamentous tension, and/or myofascial release (applied directly or indirectly).
16293770|NCT00689468|Dietary Supplement|Echinacea purpurea|1:1 weight-to-volume 50% ethanol liquid extract of the fresh roots and dried mature seeds of Echinacea purpurea. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.
16293771|NCT00689468|Procedure|Sham osteopathic manipulative treatment|Sham osteopathic treatment consisted of a series of five osteopathic examinations only (palpation of the cranial bones and muscles and other structures) without treatment maneuvers.
16293772|NCT00689468|Dietary Supplement|"Echinacea purpurea placebo"|An identically labeled placebo contained 50% ethanol, 45% filtered water, food coloring and thickeners. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.
16293773|NCT00689442|Drug|JTT-705 600 mg and atorvastatin 20 mg|"JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment
~Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments"
16293774|NCT00689442|Drug|Placebo and atorvastatin 20 mg|"Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
~Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments"
16293775|NCT00689416|Drug|rosuvastatin|40 mg, tablet, once daily for 3 months.
16293776|NCT00689416|Drug|placebo|40 mg, tablet, once daily for 3 months
16293777|NCT00689403|Drug|AZD1305|Extended release capsules, oral single doses
16293778|NCT00689403|Drug|AZD1305|Extended release capsules, oral single doses
16293779|NCT00689390|Biological|Boceprevir|In previous treatment studies, boceprevir was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390).
16293913|NCT00688480|Drug|Placebo|1 capsule, orally for 9 months
16293781|NCT00689390|Biological|Peginterferon alfa-2b|In previous treatment studies, peginterferon alfa-2b was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390).
16293782|NCT00689390|Drug|Ribavirin|In previous treatment studies, ribavirin was administered as specified by the protocol. No treatment was administered on the current follow-up study (P05063, NCT00689390).
16293783|NCT00689390|Other|Blood/Plasma Collection|Blood samples were collected at all visits during the LTFU for blood chemistry and hematology. Plasma samples were collected at all visits as appropriate from participants who were sustained responders at the end of FU in the previous treatment protocol for HCV-RNA PCR and HCV sequence analysis.
16293784|NCT00689351|Biological|13-valent pneumococcal conjugate vaccine|13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
16293785|NCT00689351|Biological|7-valent pneumococcal conjugate vaccine|7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
16293786|NCT00689338|Drug|Anidulafungin|Anidulafungin Intravenous Administration
16293787|NCT00689338|Drug|Fluconazole|Oral Administration of Fluconazole
16293788|NCT00689338|Drug|Voriconazole|Oral Administration of Voriconazole
16293789|NCT00689312|Drug|Enfalyte|Each patient will receive one 250 ml dose.
16293790|NCT00689312|Drug|Pediatric Electrolyte|Each patient will receive one 250 ml dose.
16293791|NCT00689312|Drug|Pedialyte|Each patient will receive one 250 ml dose.
16293792|NCT00689299|Biological|Standardized Allergenic Extract, Cat Hair|Standardized Cat Hair Allergenic Extract sublingual drops
16293793|NCT00689299|Biological|Placebo|Placebo Sublingual Drops
16293794|NCT00689286|Device|BION|"They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) twitch stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise.
~In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises."
16293795|NCT00689273|Drug|PF-04136309|125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval.
16293796|NCT00689273|Drug|Placebo|Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.
16293797|NCT00689260|Device|easypod|Subjects is aware that the device records injection information that can be viewed by user
16293798|NCT00689260|Device|easypod|Subjects is not aware that the device records injection information that can be viewed by user
16293799|NCT00689247|Drug|AZD1305|oral solution, single dose
16293800|NCT00689247|Drug|AZD1305|iv infusion, single dose
16293801|NCT00689234|Procedure|diaphragm plication 6 months after inclusion|thoracotomy
16293802|NCT00689234|Procedure|diaphragm plication at time of inclusion|thoracotomy
16293803|NCT00689221|Drug|Cilengitide|Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.
16293804|NCT00689221|Drug|Temozolomide|Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression.
16293805|NCT00689221|Radiation|Radiotherapy|Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy.
16293806|NCT00689208|Drug|Atropine|10 ug/kg bolus, 4 ug/kg/h infusion
16293807|NCT00689208|Drug|Physostigmine|0,12ug/kg/min
16293808|NCT00689208|Drug|Placebo Sodium|
16293809|NCT00689195|Dietary Supplement|Curcumin powder|oral capsules containing the investigational agent
16293810|NCT00689195|Dietary Supplement|Ashwagandha extract|4.5% extract of ashwagandha
16293811|NCT00689182|Procedure|monthly phlebotomy x 12 months|All patients will receive monthly phlebotomies.
16293812|NCT00689169|Drug|ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)|Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2
16293813|NCT00689169|Procedure|ASCT|ASCT : D0
16293814|NCT00689169|Drug|Rituximab|Rituximab 250 mg/m² :D-21 D-14
16293815|NCT00689156|Drug|Epirubicin, cyclophosphamide and docetaxel|Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3
16293816|NCT00689156|Drug|docetaxel, cyclophosphamide|Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
16293817|NCT00689143|Drug|sargramostim|
16293818|NCT00689117|Drug|CT Gel|Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
16293819|NCT00689117|Drug|Clindamycin Gel (clindamycin )|Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
16293820|NCT00689117|Drug|Tretinoin Gel (tretinoin)|Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
16293821|NCT00689117|Drug|Vehicle Gel|Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
16293822|NCT00689104|Drug|Mirabegron|Tablets
16293823|NCT00689104|Drug|Tolterodine|Capsules
16293824|NCT00689104|Drug|Placebo to Mirabegron|Matching mirabegron placebo tablets.
16293825|NCT00689104|Drug|Placebo to Tolterodine|Matching tolterodine placebo capsules.
16293826|NCT00689091|Device|Bispectral Index Monitor|Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols.
16293828|NCT00689078|Drug|Prednisolone Acetate 1%|One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
16293829|NCT00689078|Drug|Prednisolone Acetate 0.12%|One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
16293830|NCT00689078|Drug|Loteprednol Etabonate 0.2%|One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
16293831|NCT00689078|Drug|Placebo|One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
16293832|NCT00689065|Drug|CALAA-01|Subjects with solid tumors who satisfy the eligibility criteria will receive two, 21-day cycles of CALAA-01. A cycle will consist of four (4) 30-minute intravenous infusions administered on days 1, 3, 8, and 10 followed by 11 days of rest. If safe, a second 21-day cycle will be administered consisting of infusions on days 22, 24, 29 and 31 followed by 11 days of rest.
16293833|NCT00689052|Drug|pramipexole ER|
16293834|NCT00689052|Drug|placebo|
16293835|NCT00689039|Drug|AZD1305|ER tablet, administered as single and repeated doses.
16293836|NCT00689039|Drug|Placebo|Tablet, administered as single and repeated doses.
16293837|NCT00689026|Drug|Lubiprostone|Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep).
16293838|NCT00689026|Other|Polyethylene glycol with electrolytes|Standard oral dosing of 4L Polyethylene glycol colonoscopy preparation the day prior to their scheduled colonoscopy.
16293839|NCT00689013|Other|Personalized letter|On Day 1 of the 2nd month, a personalized letter (addressing specific patient) was mailed to current pharmacy patients with indications for the Zostavax vaccine. Current patients were defined as those receiving at least one prescription medication from the pharmacy within 6 months. The personalized letter provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
16293840|NCT00689013|Other|Flyer advertisement|Beginning on Day 1 of the 2nd month, flyer advertisements were distributed with all pharmacy sales. Flyer advertisements provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
16293841|NCT00689013|Other|Newspaper press release|During the first week of the 2nd month, local newspapers published press releases. The press release provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
16293842|NCT00689000|Drug|CHR-2797 (tosedostat): Aminopeptidase inhibitor|"Phase I: Once daily, oral ingestion of CHR-2797 capsules (60mg, 90mg, 130mg or 180mg) depending on cohort
~Phase II: Once daily, oral ingestion of 130mg CHR-2797 (recommended dose from Phase I) until progressive disease or withdrawal from the study"
16293843|NCT00688987|Drug|Hydrocortisone|Subjects will receive in random order daily (split) dosing of hydrocortisone: a low dose of 15 mg (10 in AM, 5 in PM); a medium dose of 25 mg (15 in AM, 10 in PM) and high dose of 40 mg (30 in AM, 10 in PM) for 4 months.
16293844|NCT00688987|Dietary Supplement|Isocaloric Diet|Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
16293845|NCT00688974|Procedure|Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass
16293846|NCT00688974|Procedure|Adjustable gastric band|Laparoscopic adjustable gastric band
16293847|NCT00688961|Drug|Aspirin|generic aspirin
16293848|NCT00688961|Drug|omega-3 acid ethyl esters|4, 1 g capsules q.d.
16293849|NCT00688948|Drug|Alfuzosin|Alfuzosin 10 mg once daily po for 12 weeks
16293850|NCT00688935|Biological|Melatonin|0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
16293851|NCT00688922|Drug|Pravastatin|Take an initial dose of pravastatin to start as 10mg/day, which is the recommended initial dose by Health, Labour and Welfare Ministry of Japan, and a diet counseling.
16293852|NCT00688909|Drug|letrozole|2.5 mg daily by mouth for 6 months
16293853|NCT00688896|Drug|JTT-705 600 mg and pravastatin 40 mg|"JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
~Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime"
16293854|NCT00688896|Drug|JTT-705 300 mg and pravastatin 40 mg|"JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment
~Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments
~Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime"
16293855|NCT00688896|Drug|Placebo and pravastatin 40 mg|"Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
~Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime"
16293856|NCT00688883|Drug|Fludarabine Phosphate (Fludara)|Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.
16293857|NCT00688870|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
16293858|NCT00688870|Biological|7-valent pneumococcal conjugate vaccine (7vPnC)|7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
16293859|NCT00688857|Drug|Diazoxide choline|Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
16293860|NCT00688857|Drug|Diazoxide choline|Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
16293861|NCT00688844|Drug|KuvanTM Therapy|BH4 treatment was prescribed by each participant's medical provider, not an intervention that was assigned as part of the current study.
16293862|NCT00688831|Drug|AZD1305|Solution for iv infusion , single dose
16293863|NCT00688831|Drug|Placebo|NaCl solution for iv infusion, single dose
16293864|NCT00688818|Drug|Quetiapine|Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
16293914|NCT00688480|Drug|Allopurinol|Allopurinol 300 mg once/day orally, 9 months
16293865|NCT00688818|Drug|Placebo|Patients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
16293866|NCT00688805|Drug|Propranolol|40 mg given as a single oral administration in an opaque capsule
16293867|NCT00688805|Drug|Placebo|matching capsule containing no active medication
16293868|NCT00688779|Drug|AZD8848|Concentrate for nasal spray,solution 60 mg/g
16293869|NCT00688779|Drug|Placebo|
16293870|NCT00688766|Drug|retaspimycin hydrochloride (IPI-504)|IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90). Patients will receive 400 mg/m2 of IPI-504 as a 30-minute IV infusion twice weekly for 2 weeks followed by 1 week off.
16293871|NCT00688766|Drug|placebo|Patients will receive a 30-minute IV infusion twice weekly for 2 weeks followed by 1 week off.
16293872|NCT00688766|Other|Best supportive care|Best supportive care will be according to institutional standard, but will not include administration of systemic cancer-specific therapies including chemotherapies, biologic therapies, investigational therapies, TKIs (e.g., imatinib, sunitinib, nilotinib, dasatinib), or local therapies such as surgery, radiotherapy, or lesion ablative therapies.
16293873|NCT00688753|Drug|RAD001|
16293874|NCT00688740|Drug|Docetaxel|intravenous
16293875|NCT00688740|Drug|5-fluorouracil|intravenous
16293876|NCT00688740|Drug|Doxorubicin|intravenous
16293877|NCT00688740|Drug|Cyclophosphamide|intravenous
16293878|NCT00688727|Behavioral|CBT|CBT, up to 12 sessions.
16293879|NCT00688727|Behavioral|Standard Care|Routine review by neuropsychiatrist in outpatient clinic
16293880|NCT00688714|Drug|AZD6482|0,9-364,5 mg administrated through intravenous infusion over 3 hours
16293881|NCT00688714|Drug|Placebo|
16293882|NCT00688701|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16293883|NCT00688701|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16293884|NCT00688701|Device|Pen auto-injector|
16293885|NCT00688688|Drug|Mirabegron|Tablets
16293886|NCT00688688|Drug|Tolterodine|Extended release capsules
16293887|NCT00688688|Drug|Placebo to Mirabegron|Matching mirabegron placebo tablets.
16293888|NCT00688688|Drug|Placebo to Tolterodine|Matching tolterodine placebo capsules.
16293889|NCT00688662|Procedure|ERCP with sphincterotomy|cutting the biliary sphincter muscle (sphincterotomy)
16293890|NCT00688662|Procedure|ERCP without sphincterotomy|ERCP with sphincter manometry, but no sphincterotomy
16293891|NCT00688649|Dietary Supplement|Standard Oral Nutritional Supplement (ONS)|Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)
16293892|NCT00688649|Dietary Supplement|High energy Oral Nutritional Supplement (ONS)|High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)
16293893|NCT00688636|Drug|infliximab|5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
16293894|NCT00688636|Drug|placebo|placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
16293895|NCT00688623|Drug|Everolimus|Everolimus 5 mg tablets were supplied in blister packs
16293896|NCT00688610|Other|laboratory value procalcitonin|"A. attending physician includes patient with acute respiratory infection in study, indicates antibiotic prescription and collects procalcitonin-value. Waits for decision from laboratory either change of decision or retention of decision. In case of change decision: antibiotic is not recommended, patient shall not take antibiotic. In case of retention of decision: patient may take the antibiotic.
~B. attending physician includes patient with acute respiratory infection in study, indicates NO antibiotic and collects procalcitonin-value. Waits for decision from laboratory either change of decision or retention of decision. In case of change decision: antibiotic is recommended, patient has to be informed about. In case of retention of decision: no change."
16293897|NCT00688597|Drug|Duvoglustat|Powder in a bottle for dissolution in water for oral administration
16293898|NCT00688584|Behavioral|Pamphlet-based personalized alcohol feedback (PAF)|participants in this condition will be mailed their respective pamphlets
16293899|NCT00688584|Behavioral|control pamphlet condition|The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.
16293900|NCT00688571|Device|Melody Transcatheter Pulmonary Valve|Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention
16293901|NCT00688558|Drug|JTT-705 600 mg and simvastatin 40 mg|"JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
~Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments"
16293902|NCT00688558|Drug|Placebo and simvastatin 40 mg|"Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
~Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments"
16293903|NCT00688545|Drug|Celecoxib|Non-interventional: Treatment assignment as per treating physician's judgement
16293904|NCT00688545|Drug|nsNSAIDs|Non-interventional: Treatment assignment as per treating physician's judgement
16293905|NCT00688519|Drug|U0267|All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
16293906|NCT00688519|Drug|Vehicle|All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
16293907|NCT00688506|Device|combined sono-electro-magnetic therapy (Sonodyn Medico Star)|twice a day for 10 minutes during 12 weeks
16293908|NCT00688506|Device|placebo therapy (Placebo Sonodyn Medico Star)|twice a day for 10 minutes during 12 weeks
16293909|NCT00688493|Drug|Dapagliflozin|3 x 50 mg tablets, single oral dose
16293910|NCT00688493|Drug|Dapagliflozin|2 x 10 mg capsules, single oral dose
16293911|NCT00688493|Drug|Moxifloxacin|Overencapsulated 400 mg capsule, single oral dose
16293912|NCT00688493|Drug|Placebo to match moxifloxacin and dapagliflozin|Overencapsulated 400 mg capsule, single oral dose
16293915|NCT00688467|Drug|Navarixin|30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2
16293916|NCT00688467|Drug|Placebo|Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2
16293917|NCT00688441|Drug|Nasal CO2|Twice daily during the 14 day Treatment Period
16293918|NCT00688441|Drug|Placebo|Use of the study drug dispenser at the same frequency as the active arm
16293919|NCT00688428|Drug|Esomeprazole 40mg/ASA 325mg|combination capsule, administered as a single oral dose
16293920|NCT00688428|Drug|Esomeprazole|40mg capsule, administered as a single dose
16293921|NCT00688428|Drug|ASA|325mg tablet, administered as a single oral dose
16293922|NCT00688415|Drug|VTX-2337|Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.
16293923|NCT00688402|Drug|AZD3355|Single dose
16293924|NCT00688389|Other|case/control|case: infected dengue fever people control:healthy people
16293925|NCT00688376|Drug|Donepezil hydrochloride|"During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.
~During the Blinded Extension Phase, all subjects will receive active treatment (donepezil)."
16293926|NCT00688376|Drug|Placebo|"During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.
~During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil)."
16293927|NCT00688363|Procedure|weekly blood glucose profile|once daily self-control of urinary-glucose
16293928|NCT00688363|Procedure|three-monthly haemoglobin A1c|once daily self-control of urinary-glucose
16293929|NCT00688363|Procedure|no blood-glucose self-control|once daily self-control of urinary-glucose
16293930|NCT00688350|Behavioral|Behavioral feedback|The medication adherence intervention consists of five components: medication feedback, hypertension feedback, medication-taking skills, habit adjustment, and succinct medication and disease information delivered over an 8-week period.
16293931|NCT00688324|Drug|Acamprosate|Acamprosate 333mg, ii tablets PO tid x 2 weeks
16293932|NCT00688311|Dietary Supplement|Synbiotic 2000|A preparation consisting of 4 species of probiotic bacteria (10^10 each) combined with 4 types of dietary fiber (2.5g each).
16293933|NCT00688311|Dietary Supplement|Placebo|Placebo
16293934|NCT00688298|Device|Prefyx PPS™ System|A mesh implant intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
16293935|NCT00688298|Device|Advantage ™ System|The Advantage Mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
16293936|NCT00688285|Other|automated clinical alerts|automated clinical alerts in the electronic medical record
16293937|NCT00688285|Other|provider education|PCP education session on CKD
16293938|NCT00688272|Drug|Ciprofloxacin|Given 500mg BID x 6 days
16293939|NCT00688272|Drug|Eltrombopag|Given QD x 6 days
16293940|NCT00688272|Drug|Placebo|Given QD x 6 days
16293941|NCT00688259|Behavioral|Supportive Therapy (ST)|approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery
16293942|NCT00688259|Behavioral|Cognitive Behavioral Therapy for Psychosis (CBTp)|approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
16293943|NCT00688246|Other|biologic sample preservation procedure|Increased bone turnover may be a risk factor for fracture [Lønning 2005]. However, it is uncertain whether markers of bone resorption and markers of bone formation are both associated with fracture risk [Looker 2000]. Therefore, we will measure bone formation and bone resorption markers at baseline, year 1 and year 5. Blood specimens will be shipped to and stored in a central laboratory for future assays of bone biomarkers. For markers of bone formation, the N-terminal Propeptide of Type I Collagen (PINP) will be measured. For bone resorption markers, serum levels of cross-linked N-telopeptides of type I collagen (NTx) will be measured. Note: Subjects must fast 12-14 hours prior to blood draw.
16293944|NCT00688246|Procedure|dual x-ray absorptometry|BMD of the spine (L1-L4) and total hip will be done within 12 months prior to randomization to the MAP.3 core protocol. BMD by DEXA of the spine (L1-L4) and total hip will be repeated at year 2 and year 5 of the MAP.3 core study on the same Lunar or Hologic scanner.
16293945|NCT00688233|Device|Seifi's Functional|Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.
16293946|NCT00688207|Drug|Rosiglitazone (Extended Release)|open-label, single, oral, 4mg dose
16293947|NCT00688194|Drug|anastrozole|Patients receive aromatase inhibitor therapy according to standard treatment regulations.
16293948|NCT00688194|Drug|exemestane|Patients receive aromatase inhibitor therapy according to standard treatment regulations.
16293949|NCT00688194|Drug|fulvestrant|Given intramuscularly
16293950|NCT00688194|Drug|lapatinib ditosylate|Given orally
16293951|NCT00688194|Drug|letrozole|Patients receive aromatase inhibitor therapy according to standard treatment regulations.
16293952|NCT00688194|Other|placebo|Given orally
16293953|NCT00688181|Device|The Prefyx PPS™ Pre-pubic Sling System|device designed to treat female stress urinary incontinence (SUI).
16293954|NCT00688168|Behavioral|Questionnaire|Questionnaires measuring pain and other symptoms, mood, and quality of life.
16293955|NCT00688168|Behavioral|Neurocognitive Testing|A neurocognitive exam (tests to check your memory and thinking abilities, for example) will be performed.
16293956|NCT00688168|Behavioral|Neurosensory Testing|Neurosensory testing will be performed to find out how sensitive you are to things such as touch, coolness, warmth, pinprick on the finger, and squeezing of the skin on the finger, hand, or arm.
16293957|NCT00688155|Behavioral|Physical Activity Training|Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.
16293958|NCT00688155|Behavioral|Cognitive Training|Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.
16293959|NCT00688155|Behavioral|Healthy Aging Education|One 1-hour lecture each week for 3 months, then monthly.
16293960|NCT00688129|Behavioral|KITS Program|This is a 4-month psychosocial intervention for foster children entering kindergarten and their caregivers beginning the summer before kindergarten. The KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis.
16293961|NCT00688116|Drug|STA 9090 (ganetespib)|This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.
16293962|NCT00688103|Drug|ETN Alone|etanercept (25 mg, twice/week, s.c.)
16293963|NCT00688103|Drug|ETN+MTX|etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
16293964|NCT00688090|Biological|Biological: MKC1106-MT|Cancer Vaccine, Immunotherapy
16293965|NCT00688090|Biological|Biological: MKCC1106-MT|Cancer Vaccine, Immunotherapy
16293966|NCT00688077|Drug|Calcitonin|Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
16293967|NCT00688077|Drug|Placebo|NaCl 0,9 % 1ml, single subcutaneous injection, placebo group
16293968|NCT00688064|Drug|Adapalene BPO Gel associated with Doxycyline Hyclate|Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
16293969|NCT00688064|Drug|Vehicle Gel associated with Doxycycline Hyclate|Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
16293970|NCT00688051|Other|My Life with CF game|Play the game My Life with CF
16293971|NCT00688038|Procedure|Laser Ablation|Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor.
16293972|NCT00688038|Procedure|Magnetic Resonance Thermal Imaging|MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.
16293973|NCT00688012|Drug|SPC3649|
16293974|NCT00687999|Drug|pegylated interferon alpha and ribavirin|standard pegylated interferon alpha and ribavirin
16293975|NCT00687986|Radiation|stereotactic radiotherapy|Either 3 fractions of 20 Gray or 5 fractions of 12 Gy
16293976|NCT00687986|Procedure|primary surgery|an anatomical surgical resection with lymph node dissection
16293977|NCT00687973|Drug|Valsartan/amlodipine 80/5 mg tablets|
16293978|NCT00687973|Drug|Amlodipine 5 mg capsules|
16293979|NCT00687973|Drug|Amlodipine 10 mg capsules|
16293980|NCT00687973|Drug|Atenolol 50 mg tablets|
16293981|NCT00687973|Drug|Atenolol 100 mg tablets|
16293982|NCT00687960|Dietary Supplement|Resistant starch type 4 - raw|Dose: 80g bar containing Resistant Starch Type 4 - raw
16293983|NCT00687960|Dietary Supplement|Resistant Starch Type 4 - Cooked|Dose: 80g bar containing Resistant Starch Type 4 - cooked
16293984|NCT00687960|Dietary Supplement|Dextrose|Dose: 7 oz of oral glucose tolerance beverage
16293985|NCT00687960|Dietary Supplement|Puffed Wheat|Dose: 80g bar containing puffed wheat cereal
16293986|NCT00687947|Drug|CGRP|CGRP (0.5 ug/min) infused intravenously over 20 min
16293987|NCT00687934|Drug|STA-9090|This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.
16293988|NCT00687908|Drug|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel|Topical Gel to the face, once daily in the evening for 24 weeks.
16293989|NCT00687908|Drug|Vehicle Gel|Topical Gel to the face, once daily in the evening for 24 weeks.
16293990|NCT00687895|Procedure|Clinical algorithm and microscopy diagnosis of malaria|"Clinical alogarithm
~The content of the package included
~description of signs and symptoms of malaria disease
~history taking relevant to malaria and physical examination
~identification of danger signs and severe illness for referral
~appropriate treatment
~counseling patients on the use of drugs.
~Malaria microscopy. contents
~make thick blood smears from patients with fever and stain with Giemsa
~identify and count malaria parasites
~maintain the microscope and store blood slides."
16293991|NCT00687882|Other|Shortened duration (6 weeks) of anticoagulant therapy|Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
16293992|NCT00687882|Other|Conventional duration (3 months) of anticoagulant therapy|Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
16293993|NCT00687882|Other|No Intervention|Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
16293994|NCT00687882|Other|No Intervention|Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
16293995|NCT00687869|Behavioral|Case management|Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
16293996|NCT00687869|Behavioral|Case management|Usual stroke aftercare plus patient-information-notes
16293997|NCT00687856|Procedure|Echocardiogram (echo)|Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts.
16293998|NCT00687843|Drug|Tegafur-gimeracil-oteracil potassium (TS-1)|80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
16293999|NCT00687843|Drug|Krestin (PSK)|3 g, PO from day 1 to day 336
16294000|NCT00687830|Drug|Polyethylene Glycol afternoon|Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
16294001|NCT00687830|Drug|Polyethylene Glycol morning|Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
16294002|NCT00687817|Drug|bavituximab plus paclitaxel and carboplatin|Weekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles)
16294003|NCT00687804|Drug|Ranibizumab|0.5 mg ranibizumab administered by intravitreal injection.
16294004|NCT00687804|Procedure|Laser|Laser photocoagulation treatment
16294005|NCT00687804|Procedure|Sham laser|Sham to laser procedure.
16294006|NCT00687804|Drug|Sham to ranibizumab|Sham to ranibizumab administered as an intravitreal injection.
16294007|NCT00687791|Device|ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery|Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
16294008|NCT00687765|Drug|bsi-201 plus temozolomide|BSI-201 given iv. 2x weekly, temozolomide given orally
16294009|NCT00687739|Drug|leuprolide acetate|3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
16294010|NCT00687739|Drug|Estradiol Transdermal|0.075 mg patch per day for 5 months
16294011|NCT00687739|Behavioral|progressive resistance exercise training|45 minute exercise sessions 4 times per week for 5 months
16294012|NCT00687726|Behavioral|Standing balance exercise|Standing balance and mini squat exercise performed 30 times/day/side, 5 days/week, for 4 weeks.
16294013|NCT00687726|Behavioral|Isometric knee extension exercise|Isometric knee extension exercise performed 10 repetitions/set, 3 sets/day, 5 days/week for 4 weeks
16294014|NCT00687713|Drug|Bupropion|150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
16294015|NCT00687713|Other|Placebo|Placebo
16294016|NCT00687700|Drug|GSK961081|GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.
16294017|NCT00687700|Drug|GSK961081 matching placebo|GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.
16294018|NCT00687700|Drug|Propranolol|Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.
16294019|NCT00687700|Drug|Propranolol matching placebo|Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.
16294020|NCT00687687|Drug|paclitaxel|Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
16294021|NCT00687687|Drug|carboplatin|Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
16294022|NCT00687687|Drug|BSI-201 (Iniparib)|BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days).
16294023|NCT00687674|Drug|dexamethasone|20 mg orally Days 1, 8, 15, 22 of 28 day cycle
16294024|NCT00687674|Drug|sorafenib tosylate|Phase I - dose escalating: 200mg once daily dose level -2, 200mg once daily dose level -1, 200mg once daily dose level 0, 200mg twice daily dose level 1, 200mg twice daily dose level 2, 400mg AM & 200mg PM daily dose level 2a, 400mg twice daily dose level 3 orally days 1-28 every 28 days until progression
16294025|NCT00687674|Drug|Lenalidomide|Phase I - dose escalating: 5mg level -2, 10mg level -1, 15mg level 0, 15mg level 1, 25mg level 2, 25mg level 2a, 25mg level 3 orally days 1-21 every 28 days until progression
16294026|NCT00687661|Drug|Bisphosphonate|35mg given orally once weekly for 24 months
16294027|NCT00687661|Drug|Placebo|identical placebo pill once weekly for 24 months
16294028|NCT00687648|Drug|anastrozole|Given as previously prescribed
16294029|NCT00687648|Drug|cyclophosphamide|Given by mouth
16294030|NCT00687648|Drug|exemestane|Given as previously prescribed
16294031|NCT00687648|Drug|letrozole|Given as previously prescribed
16294032|NCT00687648|Drug|methotrexate|Given by mouth
16294033|NCT00687648|Drug|prednisolone|Given by mouth
16294034|NCT00687622|Drug|GSK1120212|Part 1-dose-escalation Part 2 - Recommended Part 2 dose Part 3 - characterize the range of biologically effective doses
16294035|NCT00687609|Drug|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
16294036|NCT00687596|Drug|TAC-101|Patients randomized to TAC 101 will receive TAC 101 20 mg (administered as 2 10 mg formulated tablets) PO daily with approximately 240 mL (8 oz) of water under fed conditions (no later than 1 hour after a meal) for 14 days followed by a 7 day recovery period. This cycle will be repeated every 21 days.
16294037|NCT00687596|Drug|Placebo|Patients randomized to placebo will receive 2 placebo tablets (identical in appearance to the TAC 101 tablets) administered PO daily with approximately 240 mL (8 oz) of water under fed conditions (no later than 1 hour after a meal) in a regimen identical to that for TAC 101.
16294038|NCT00687570|Dietary Supplement|Fresubin Energy Drink|Fresubin energy drink 30 kcal/kg*dag-1, seven days before surgery
16294039|NCT00687570|Drug|Laxabon®|Laxabon® 4 litres starting the day before surgery
16294040|NCT00687544|Biological|Peginterferon alfa-2b (SCH 054031)|Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.
16294041|NCT00687544|Drug|Ribavirin (SCH 018908)|Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is <65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is >85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.
16294042|NCT00687531|Drug|Mometasone Furoate|Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
16294043|NCT00687518|Drug|Erythropoietin|Intravenous injection of 50 U/kg of erythropoietin
16294044|NCT00687518|Drug|Placebo|Intravenous injection of equivalent volume of saline serum
16294045|NCT00687505|Drug|FP-1039|Intravenous weekly administration
16294046|NCT00687466|Drug|Insulin|"Insulin Glargine will be administered subcutaneously at the dosage of 0.1 U/Kg/die for three months. In case no hypoglycemic episodes occur during this period, the dosage will be increased to 0.15 U/Kg/die in occasion of the first control (T1) and will be scheduled for other three months. If even during this latter period no cases no hypoglycemic episodes occur, at the second control (T2) the dosage will be increased to the maximum of 0.2/U/Kg/die. It is generally accepted that the final dosage of glargine can be tailored to each patient, but it should be maintained between 0.1 and 0.2 U/Kg/die.
~Glargine should be administered once daily in the morning and always at the same hour."
16294047|NCT00687453|Drug|Insulin glargine at bedtime instead of NPH|Insulin glargine at bedtime substituting for NPH insulin at bedtime
16294048|NCT00687453|Drug|NPH twice-daily|Addition of morning NPH to bedtime NPH
16294049|NCT00687440|Drug|Pegylated Liposomal Doxorubicin|"Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m^2 on day 1, every 3 weeks
~Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks."
16294050|NCT00687440|Drug|Docetaxel|Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks.
16294051|NCT00687440|Drug|Trastuzumab|Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks).
16294052|NCT00687427|Behavioral|Questionnaires and motor/sensitivity testing|"Group A:
~Full assessment (using the various measures described) will be carried out 0-3 weeks since referral.
~Treatment will focus on the patient's needs and in accordance with the physicians requests.
~Three months post initial treatment re-assessment will be conducted."
16294053|NCT00687427|Behavioral|Questionnaires and motor/sensitivity testing|Group B Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects.
16294054|NCT00687427|Behavioral|Questionnaires and motor/sensitivity testing|Group C Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects.
16294055|NCT00687401|Biological|Infliximab|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
16294056|NCT00687388|Drug|selective alpha 1-blockers|Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)
16294057|NCT00687388|Drug|celecoxib|200mg daily for 8 weeks
16294058|NCT00687388|Drug|alpha-blocker and NSAID|amsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks and celecoxib 200mg daily for 8 weeks
16294059|NCT00687375|Procedure|Laparoscopic Inguinal Hernia Repair|Laparoscopic Inguinal Hernia Repair using Transabdominal preperitoneal (TAPP) Approach
16294060|NCT00687375|Procedure|Laparoscopic Inguinal Hernia Repair|Laparoscopic Inguinal Hernia Repair using totally extra peritoneal (TEP) Approach
16294061|NCT00687362|Biological|Infliximab|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
16294062|NCT00687349|Behavioral|Training Program Intervention|Resident or NP Student receives the educational intervention during 8 half-day sessions.
16294063|NCT00687336|Other|Empirical Hp eradication|Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
16294064|NCT00687336|Other|Eradication treatment guided by a positive test|Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.
16294065|NCT00687323|Drug|temozolomide|
16294066|NCT00687310|Behavioral|Educational intervention|Tailored asthma education based on needs assessment
16294067|NCT00687297|Drug|vandetanib induction|100 mg daily by mouth
16294068|NCT00687297|Drug|Docetaxel|(75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression
16294069|NCT00687297|Drug|Carboplatin|IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression
16294070|NCT00687297|Drug|Placebo|
16294071|NCT00687297|Drug|Vandetanib maintenance|300 mg daily by mouth
16294072|NCT00687284|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16294073|NCT00687271|Drug|MK-6213|MK-6213 160 mg for 4 weeks.
16294074|NCT00687271|Drug|Atorvastatin calcium|atorvastatin calcium 20mg for 4 weeks.
16294075|NCT00687271|Drug|Placebo for MK-6312 160 mg|
16294076|NCT00687271|Drug|Placebo for Atorvastatin 20 mg|
16294077|NCT00687258|Device|VitabranE ViE|Polysulfone dialyser with vitamin E alpha-tocopherol
16294078|NCT00687245|Drug|esomeprazole magnesium|capsules, oral, qd, one day
16294079|NCT00687232|Drug|AZD4818|Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days
16294080|NCT00687232|Drug|Placebo|
16294081|NCT00687219|Biological|Peginterferon alfa-2b|Administered at 1.0 µg/kg/week SC for 48 weeks
16294082|NCT00687219|Drug|Ribavirin|Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL; treatment duration is 48 weeks
16294083|NCT00687206|Drug|Valsartan 160mg plus HCT 25mg|valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months
16294084|NCT00687193|Drug|Placebo|Placebo BID, 3 blinded tablets administered BID for 12 weeks
16294085|NCT00687193|Drug|CP-690,550|10mg BID, 3 blinded tablets administered BID for 12 weeks
16294086|NCT00687193|Drug|CP-690,550|15mg BID, 3 blinded tablets administered BID for 12 weeks
16294087|NCT00687193|Drug|CP-690,550|1mg BID, 3 blinded tablets administered BID for 12 weeks
16294088|NCT00687193|Drug|CP-690,550|3mg BID, 3 blinded tablets administered BID for 12 weeks
16294089|NCT00687193|Drug|CP-690,550|5mg BID, 3 blinded tablets administered BID for 12 weeks
16294090|NCT00687180|Drug|Treatment with mycophenolat mofetil|
16294091|NCT00687180|Drug|Treatment with azathioprin|
16294092|NCT00687167|Drug|Zonisamide 100 mg Capsule|100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.
16294093|NCT00687167|Drug|Zonisamide (Zonegran®) 100 mg Capsule|100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.
16294094|NCT00687154|Procedure|Scatter Laser Photocoagulation in 1 Sitting|1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator.
16294095|NCT00687154|Procedure|Scatter Laser Photocoagulation in 4 Sittings|4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns.
16294096|NCT00687141|Drug|AZD0328|Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.
16294097|NCT00687141|Drug|Placebo|Administered orally as a solution once per day on day 1, and then day 3 through to day 14.
16294098|NCT00687128|Behavioral|Low-intensity treadmill exercise|Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
16294099|NCT00687128|Behavioral|Moderate-intensity treadmill exercise|Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
16294100|NCT00687128|Behavioral|Non-aerobic stretching exercise|Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.
16294101|NCT00687115|Behavioral|Weight Loss|liquid diet at 50% of weight maintaining intake
16294102|NCT00687115|Behavioral|Overfeeding|Overfeeding at 150% of weight maintaining intake
16294103|NCT00687115|Behavioral|Overfeeding Low Pro|Overfeeding 150% of normal intake at <5% protein
16294104|NCT00687102|Drug|tamoxifen|oral tamoxifen plus placebo daily for 5 years
16294105|NCT00687102|Drug|raloxifene|oral raloxifene plus placebo daily for 5 years
16294106|NCT00687089|Other|Sexual, cognitive functional tests and measurement weight|
16294107|NCT00687076|Drug|Ezetimibe|Daily dose of 10 mg of Ezetimibe
16294108|NCT00687076|Drug|Niaspan|Daily dose of 1500 mg of Niaspan
16294109|NCT00687076|Drug|Statin therapy|Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
16294110|NCT00687076|Behavioral|Standard care|Standard of medical care for PAD
16294111|NCT00687076|Drug|Aspirin|Daily dose of 325 mg of aspirin
16294112|NCT00687076|Drug|Clopidogrel|Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
16294113|NCT00687076|Drug|Placebo Niaspan|Daily dose of 1500 mg of placebo Niaspan
16294114|NCT00687076|Drug|Placebo Ezetimibe|Daily dose of 10 mg of placebo Ezetimibe
16294115|NCT00687076|Procedure|Percutaneous transluminal angioplasty (PTA)|Participants who have not had an endovascular intervention in the 3 months before study entry will undergo PTA to mechanically open the artery blockages. This procedure will involve the inflation and deflation of a small balloon to open the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area if deemed necessary by their physicians.
16294116|NCT00687063|Drug|insulin detemir|Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician
16294117|NCT00687050|Dietary Supplement|peroral high-caloric supplemental nutrition|HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet
16294118|NCT00687050|Dietary Supplement|peroral supplemental nutrition|Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet
16294119|NCT00687037|Drug|Cetylpyridinium chloride|
16294120|NCT00687024|Procedure|Magnetoencephalography|MEG will be performed on a whole head Omega 151-channel gradiometer system. At least 15 2-minute periods of spontaneous data are recorded. The sampling rate for data acquisition is 625Hz, with a bandpass filter of 3 to 70 Hz and a notch filter of 60Hz.
16294121|NCT00687024|Procedure|MR imaging|MR imaging will be performed on a GE 1.5T system using a variety of sequences, including sagittal T1, axial T2, axial FLAIR, coronal dual echo, coronal FLAIR, axial 3D T2 frFSE and axial SPGR.
16294122|NCT00687024|Procedure|Diffusion Tensor Imaging|Diffusion tensor imaging will be performed on the same scanner, using single shot diffusion-weighted echo planar imaging. Twenty-five 'xial contiguous slices are obtained aligned to the anterior commissure line to cover the whole brain, giving a total imaging time of 4min 40sec.
16294123|NCT00687011|Drug|Palonosetron and Dexamethasone|0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).
16294124|NCT00686998|Drug|AZD2624|Oral Suspension
16294125|NCT00686998|Drug|Olanzapine|PO BID
16294126|NCT00686998|Drug|Placebo|
16294127|NCT00686985|Drug|Carboplatin, docetaxel|Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks
16294128|NCT00686972|Drug|GLP-1|5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
16294129|NCT00686959|Drug|Pemetrexed|infusion over 10 minutes
16294130|NCT00686959|Drug|Cisplatin|infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
16294131|NCT00686959|Drug|Etoposide|administered per local practice guidelines over a minimum of 30 minutes
16294132|NCT00686959|Drug|Vinorelbine|administered over 6-10 minutes infusion per local practice guidelines
16294133|NCT00686959|Drug|Paclitaxel|administered as a 3-hour infusion
16294134|NCT00686959|Drug|Carboplatin|administered per local practice guidelines over 30 minutes
16294135|NCT00686959|Radiation|Thoracic Radiation Therapy (TRT)|
16294136|NCT00686933|Drug|ABT-089|Subjects will take up to 80 mg daily for 24 months
16294137|NCT00686920|Drug|Rifaximin|Oral
16294138|NCT00686894|Procedure|PDUS|PDUS scored for each enthesitis every 2 weeks for 24 weeks.
16294139|NCT00686894|Drug|Infliximab|"5 mg/kg
~IV
~Frequency : weeks 0,2,6"
16294140|NCT00686881|Biological|Peginterferon alfa-2b (PegIFN-2b)|PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
16294141|NCT00686881|Drug|Comparator: Stronger neo minophagen C (SNMC)|SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .
16294142|NCT00686868|Other|placebo|placebo
16294143|NCT00686868|Drug|ofatumumab|fully human anti-CD20 monoclonal antibody
16294144|NCT00686855|Drug|Tacrolimus|Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
16294145|NCT00686855|Drug|Dexamethasone|Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
16294146|NCT00686842|Drug|VEGF inhibitor PTC299|20 mg capsules to be taken by mouth BID. Three dose levels will be evaluated: 40 mg, 80mg, and 100mg BID. Subjects will receive PTC299 in consecutive 28-day cycles for a maximum of 12 cycles.
16294147|NCT00686842|Genetic|gene expression analysis|To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
16294148|NCT00686842|Genetic|polymerase chain reaction|To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
16294149|NCT00686842|Genetic|protein expression analysis|To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
16294150|NCT00686842|Other|immunohistochemistry staining method|To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
16294151|NCT00686842|Other|laboratory biomarker analysis|To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
16294152|NCT00686842|Other|pharmacological study|To describe the pharmacokinetics of PTC299 in patients with HIV-associated KS. To describe the effects of PTC299 on circulating VEGF, VEGFR and cytokine levels in patients with HIV-associated KS.
16294153|NCT00686842|Procedure|biopsy|To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
16294154|NCT00686829|Drug|Vicriviroc maleate|VCV 30 mg tablet once daily by mouth.
16294155|NCT00686816|Dietary Supplement|Low calorie diet|low calorie diet
16294156|NCT00686816|Dietary Supplement|Olestra|low calorie Olestra diet
16294157|NCT00686803|Drug|PL3994|Study drug
16294158|NCT00686803|Drug|Placebo|Placebo
16294159|NCT00686790|Biological|Peginterferon alfa-2b (PegIntron, SCH 54031)|Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
16294160|NCT00686777|Biological|Pegylated Interferon alfa-2b|Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
16294161|NCT00686777|Drug|Ribavirin|Ribavirin 400 mg/day orally
16294162|NCT00686764|Other|Observational|"Using ultrasound, we will measure the cross-sectional area of the neuroma at its widest point and compare to the cross-sectional area of the same nerve at the lesser trochanter.
~We will be using four different metrics for quantifying the pain experience of each subject: Questionnaire for Persons with Transfemoral Amputation (Q-FTA), Trinity Amputation and Prosthesis Experience Scales (TAPES), Visual Analog Scale (VAS), and the Short-Form 36 (SF-36)."
16294163|NCT00686751|Drug|paricalcitol|Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks.
16294164|NCT00686725|Drug|Temozolomide|
16294165|NCT00686725|Radiation|Radiotherapy|
16294166|NCT00686712|Drug|1- Insulin glargine QHS|Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)
16294167|NCT00686712|Drug|2 - Insulin glargine QAM|Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)
16294168|NCT00686712|Drug|3 - NPH insulin QHS|NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
16294169|NCT00686699|Drug|Preladenant|capsules
16294170|NCT00686699|Drug|Placebo|capsules
16294171|NCT00686686|Biological|Infliximab|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
16294172|NCT00686673|Behavioral|Providing tailored message on disclosing terminal illness|an experimental intervention group that receives a decision aid consisting of targeted educational video and manual providing a protocol for disclosing terminal illness and aimed at improving communication between patients and their family
16294173|NCT00686673|Behavioral|Providing non-tailored message on pain control|an attention control group that receives non-tailored video and manual on pain control
16294174|NCT00686660|Behavioral|cycling, walking|"In training period, patients do cycling on cycle ergometry. two times per week, 8 weeks per training period, two training period per year, two years.
~In non-training period, patients do walking at community. four days per week,18 weeks per non-training period, two non-training period per year, two years."
16294175|NCT00686660|Behavioral|cycling, non-walking|"In training period, patients do cycling. two times a week, 8 weeks per training period, two training period per year, two years.
~In non-training period, patients don't receive walk training."
16294176|NCT00686660|Behavioral|walking, walking|"In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years.
~In non-training period, patients do walking at community, four days per week, 18 weeks per non-training period, two non-training period per year, two years."
16294177|NCT00686660|Behavioral|walking, non-walking|"In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years.
~In non-training period, patients don't walking at community."
16294178|NCT00686647|Device|AngioSculpt® Scoring Balloon Catheter|Use of a stent for the main branch of a bifurcation lesion and use of a scoring balloon for the side branch of the same bifurcation lesion
16294179|NCT00686647|Device|AngioSculpt Scoring Balloon Catheter|Treatment of the side-branch vessel of true bifurcation lesions using the AngioSculpt device
16294180|NCT00686634|Drug|Sitagliptin|Sitagliptin 100 mg by mouth once daily
16294181|NCT00686621|Drug|Posaconazole|Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day.
16294182|NCT00686608|Dietary Supplement|glucose|0.3mg/kg of glucose
16294183|NCT00686608|Dietary Supplement|fructose|fructose IV bolus
16294184|NCT00686608|Dietary Supplement|saline|IV saline
16294185|NCT00686595|Biological|Infliximab|Infliximab 5 mg/kg IV infusion.
16294186|NCT00686582|Biological|IMVAMUNE|1x 10E8_TCID50
16294187|NCT00686582|Biological|IMVAMUNE|1x 10E8_TCID50
16294188|NCT00686582|Procedure|Blood Draw Only|
16294189|NCT00686556|Drug|cyclophosphamide|60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
16294190|NCT00686556|Drug|cyclosporine|Beginning on Day -3 pre-transplant maintaining a level of >200 ng/mL. CSA dosing will be monitored and altered as clinically appropriate by Pharm D or physician, and discontinue at approximately day + 180 post-transplant.
16294191|NCT00686556|Drug|Fludarabine|25 mg/m2/day intravenous as a 1 hour infusion for consecutive 3 days pre-transplant, total dose 75 mg/m2
16294192|NCT00686556|Drug|mycophenolate mofetil|Beginning on day -3, use intravenous route between days -3 and +5, followed by oral administration on Day +6 through +30, if tolerated. 15mg/kg/dose for patients <40 kg, 3 gm/day for patients >40 kg.
16294193|NCT00686556|Radiation|total marrow irradiation|Dose escalating schedule per Cohort (TMI: 300 cGy) once daily.
16294194|NCT00686556|Procedure|umbilical cord blood transplantation|product will be infused via intravenous drip on Day 0 according to current University of Minnesota guidelines for Umbilical Cord Blood Grafts
16294195|NCT00686556|Biological|Granulocyte colony-stimulating factor|5 mcg/kg/day intravenous or subcutaneous based on body weight beginning on Day +1 after umbilical cord blood infusion until absolute neutrophil count exceeds 2.5 x 10^9/L for 3 consecutive days.
16294196|NCT00686556|Biological|HLA-matched related donor bone marrow|Related donor bone marrow or mobilized stem cells will be collected (target cell dose 5x10^8 nucleated cells/kg recipient weight, minimum 3x10^8 nucleated cells/kg recipient weight) and infused without processing on day 0 according to University of Minnesota Blood and Marrow Transplant Program guidelines.
16294197|NCT00686543|Drug|Posaconazole|Posaconazole will be used for prophylaxis
16294198|NCT00686530|Procedure|MR Imaging|Postmortem MR will be included as part of the autopsy examination in cases of suspected brain malformations. Imaging will be done using 1.5T GE CV/I MRI magnet. The specimen is scanned, following fixation, using an 8-channel head coil or 8-channel knee coil, depending on the size of the brain. Structural postmortem MR will include spin-echo T1, axial SPGR, and T2 imaging in three planes. Diffusion tensor imaging will be performed in the coronal plane.
16294199|NCT00686530|Procedure|Autopsy|Autopsy will be performed according to accepted standards, based on clinical indications. Macroscopic examination of the fetus will be performed initially , followed by organ removal for tissue fixation for a period of two weeks.
16294200|NCT00686517|Biological|Pegylated interferon alfa-2b|1.5 ug/kg/week SC for 12 or 24 weeks
16294201|NCT00686517|Drug|Ribavirin|Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
16294202|NCT00686504|Drug|AZD2066|single dose of oral dose, 3 times per subject
16294203|NCT00686504|Drug|radioligand [11C] AZ12713580|single dose of iv administered 4 times per subject (3 times together with AZD2066)
16294204|NCT00686478|Drug|interferon alpha 2b|1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
16294205|NCT00686465|Other|PET/CT scan|Patients will undergo whole body FDG-PET/CT imaging
16294206|NCT00686439|Drug|adalimumab|subcutaneous injection 40mg on alternate weeks
16294207|NCT00686439|Drug|adalimumab|subcutaneous injection 40mg every other week
16294208|NCT00686426|Dietary Supplement|Dairy Foods|Adequate dairy (> 3 standard daily servings)
16294209|NCT00686426|Dietary Supplement|Dairy Foods|< 1 standard dairy serving/day
16294210|NCT00686413|Drug|AZD3480|single dose, oral
16294211|NCT00686413|Radiation|2-[18F]-F-A85380|Single dose, IV
16294212|NCT00686400|Other|TAU = treatment as usual|medication and psychosocial interventions to be chosen by treating psychiatrist
16294213|NCT00686374|Biological|Adalimumab|Participants who enrolled into the study from blinded therapy in Study M06-806 received open-label (OL) therapy at a dose dependent on their body weight. Participants weighing ≥ 40 kg received 40 mg of adalimumab every other week (eow), and those who weighed < 40 kg received 20 mg of adalimumab eow. Starting at Week 8, participants who had a disease flare may have been switched to every week (ew) treatment at the same dose of adalimumab received while on eow treatment. Participants who enrolled from OL therapy in Study M06-806 continued to receive the same dose they were receiving (i.e., 40 mg ew or 20 mg ew) at the Week 52 visit of Study M06-806. Adalimumab dose could have been decreased to the next lower treatment level for those with body weight changes. Participants who responded to treatment may have also had their dosage frequency decreased from ew to eow dosing, as well as a decrease in dosage.
16294214|NCT00686361|Drug|Choline supplementation|Chart data, height, weight, pulmonary function, dietary intake and a venous blood and urine sample will be collected at enrollment then every 3 months for 9 months. Choline supplementation will be from enrollment for 6 months, with follow up at 3 months post supplementation. To avoid additional hospital visits and blood draws, and to co-ordinate with pulmonary function, hematology, clinical chemistry tests as part of clinical care, each subject will be seen at routine scheduled clinic appointments, which are every 3 months.
16294215|NCT00686335|Drug|Lodotra|Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period.
16294216|NCT00686335|Drug|Cortancyl|Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).
16294217|NCT00686322|Drug|Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)|Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
16294218|NCT00686296|Other|Taliderm™|taliderm™ dressing application once
16294219|NCT00686296|Other|Taliderm™|Taliderm™ dressing application up to three applications
16294220|NCT00686296|Other|standard wet to dry dressing with gauze|wet to dry dressing standard of care
16294221|NCT00686283|Behavioral|PEP intervention|This study will explore the feasibility of adherence to a personalized exercise prescription (PEP) in adolescents with type 1 or type 2 diabetes. The PEP intervention consists of a 2-hour group education session and a 16-week personalized exercise plan implemented in the home or community setting with the use of parental support and care ambassadors. Care ambassadors will maintain consistency of interactions with specific families for the duration of the PEP intervention. This consistency will aid in establishing rapport with the adolescents and parents to answer any questions and provide guidance for adhering to the PEP plan. The PEP intervention will be mutually planned with each teen and parent based upon the assessment of the teen's personal and cultural choices, including family and community resources. Exercise frequency, duration, and intensity for the teen with diabetes will be documented with a MTI ActiGraph accelerometer (Fort Walton Beach, FL).
16294222|NCT00686270|Drug|apricitabine|Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
16294223|NCT00686257|Device|Total face mask (interface for NPPV)|NPPV is applied by this mask, as long as NPPV is received.
16294224|NCT00686257|Device|Comfort full or RT040 oronasal mask (interface for NPPV)|NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
16294225|NCT00686244|Other|Combined 3-monthly endurance and strength training|"Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET).
~Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism"
16294226|NCT00686231|Drug|Nitroglycerin 15mg|15mg Nitroglycerin applied topically to one wrist
16294227|NCT00686231|Drug|Nitroglycerin 30mg|30mg Nitroglycerin applied topically to one wrist
16294228|NCT00686231|Drug|Lidocaine 20mg|20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
16294229|NCT00686231|Drug|Lidocaine 40mg|40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
16294230|NCT00686231|Drug|Placebo|Topical skin moisturizing cream with same appearance as active agent
16294231|NCT00686218|Drug|imatinib mesylate|Given orally
16294232|NCT00686218|Drug|panobinostat|Given orally
16294233|NCT00686218|Genetic|polymerase chain reaction|Testing
16294234|NCT00686218|Genetic|protein expression analysis|Testing
16294235|NCT00686218|Genetic|western blotting|Testing
16294236|NCT00686218|Other|flow cytometry|Testing
16294237|NCT00686218|Other|laboratory biomarker analysis|Testing
16294238|NCT00686218|Other|pharmacological study|Testing
16294239|NCT00686205|Device|collection of follow-up sample based on PRISM HIV O Plus result|Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
16294240|NCT00686192|Dietary Supplement|Calcium Carbonate|1500 mg per day
16294241|NCT00686179|Drug|AZD3480|Capsule, oral, single dose, 6 days
16294242|NCT00686179|Drug|Moxifloxacin|Capsule(encapsulated), oral, single dose
16294243|NCT00686179|Drug|PLACEBO|Capsule, oral, single dose
16294244|NCT00686166|Biological|cetuximab|"Chemotherapy cycle 1: Cetuximab, 400 mg/m^2, IV, Day 1; Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
~Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78"
16294245|NCT00686166|Drug|capecitabine|"Chemotherapy Cycle 1: Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
~Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)"
16294246|NCT00686166|Drug|oxaliplatin|"Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
~Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78"
16294247|NCT00686166|Procedure|therapeutic surgical procedure|Surgical resection
16294248|NCT00686166|Radiation|radiation therapy|IMRT (intensity-modulated radiation therapy)
16294249|NCT00686140|Drug|celecoxib|400mg/day, twice a day, 12 weeks
16294250|NCT00686140|Drug|Placebo|twice a day, 12 weeks
16294251|NCT00686127|Drug|Lidoderm patch|1 patch was applied topically to the affected site(s) for 12 hours each day.
16294252|NCT00686127|Drug|Placebo patch|1 patch was applied topically to the affected site(s) for 12 hours each day.
16294253|NCT00686114|Drug|Paclitaxel|135mg/m2, day 1 and day 29 of the radiotherapy.
16294254|NCT00686114|Drug|Cisplatin|20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
16294255|NCT00686114|Drug|Tarceva|150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
16294256|NCT00686114|Radiation|Radiotherapy|Enlarged field radiotherapy
16294257|NCT00686114|Radiation|Radiotherapy|Conventional field radiotherapy
16294258|NCT00686088|Drug|PRX302|Determination of the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate.
16294259|NCT00686075|Biological|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months will receive MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
16294260|NCT00686075|Other|Placebo, Cohort 1|Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
16294261|NCT00686075|Biological|MEDI-534, Cohort 2|Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
16294262|NCT00686075|Other|Placebo, Cohort 2|Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
16294263|NCT00686075|Biological|MEDI-534, Cohort 3|Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
16294264|NCT00686075|Other|Placebo, Cohort 3|Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
16294265|NCT00686075|Biological|MEDI-534, Cohort 4|Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
16294266|NCT00686075|Other|Placebo, Cohort 4|Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
16294267|NCT00686075|Biological|MEDI-534, Cohort 5|Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
16294268|NCT00686075|Other|Placebo, Cohort 5|Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
16294269|NCT00686062|Other|Control - computerized age-appropriate prenatal testing educational brochure|Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.
16294270|NCT00686062|Other|PT Tool - interactive, computerized, prenatal testing decision tool|An interactive, computerized prenatal testing decision-assisting tool (PT Tool).
16294271|NCT00686036|Drug|vandetanib|300 mg orally, once daily for up to 18 months
16294272|NCT00686036|Drug|Placebo|
16294273|NCT00686023|Procedure|internal fixation (DHS - richard nail)|internal fixation
16294274|NCT00686023|Procedure|internal fixation (inflatable PFN by DISCOTEC)|internal fixation
16294275|NCT00686010|Drug|Placebo|Placebo tablet, 3 tablets, oral, once daily after breakfast
16294276|NCT00686010|Drug|JTT-705 300mg|JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.
16294277|NCT00686010|Drug|JTT-705 600mg|JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast
16294278|NCT00686010|Drug|JTT-705 900mg|JTT-705 tablet, 3 tablets, oral, once daily, after breakfast
16294279|NCT00685971|Dietary Supplement|5000 IU of cholecalciferol|5 drops taken once daily for 12 weeks
16294280|NCT00685971|Dietary Supplement|placebo|5 drops once daily for 12 weeks
16294281|NCT00685958|Drug|enoxaparin (XRP4563)|14 days of treatment
16294282|NCT00685945|Drug|Control (bradykinin)|Graded doses of bradykinin (Clinalfa AG, Läufelfingen, Switzerland) will be infused at 50, 100, and 200ng/min. Each dose will be infused for 5 minutes and FBF will measured during the last 2 minutes of infusion. Arterial and venous blood samples will be obtained for measurement of net t-PA release after each dose.
16294283|NCT00685945|Drug|L-NMMA + bradykinin|Thirty minutes after administration of bradykinin a continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be started started. While continuing the infusion of L-NMMA, baseline measurements and infusion of bradykinin will be repeated.
16294284|NCT00685945|Drug|Isosorbide + L-NMMA + bradykinin|Following the second bradykinin infusion, 12 subjects will receive 5mg isosorbide dinitrate (an exogenous NO donor; Major Pharmaceuticals Inc, Livonia MI). Sixty minutes after the administration of isosorbide the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.
16294285|NCT00685945|Drug|Sildenafil + L-NMMA + bradykinin|Following the second bradykinin infusion, 12 subjects will receive 50mg sildenafil (phosphodiesterase type 5 (PDE5) inhibitor to increase cGMP without increasing NO; Pfizer, NY). Sixty minutes after the administration of sildenafil the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.
16294286|NCT00685932|Device|Mobius Retractor|The Mobius retractor is a dual ring elastic self retaining retractor that is inserted into the abdominal cavity after the peritoneal incision has been established. It is then left in place during the hysterotomy incision, delivery of the fetus, hysterotomy repair, inspection and irrigation.
16294287|NCT00685919|Drug|Carbidopa|200 mg every 6 hours for 5 doses given orally
16294288|NCT00685919|Drug|Placebo|every 6 hours for 5 doses, given orally, and matching Carbidopa
16294289|NCT00685906|Drug|AZD6140|90 mg tablet taken by mouth 2 times a day for 21 days per cycle
16294290|NCT00685906|Drug|Levonorgestrel and Ethinyl Estradiol (Nordette®)|1 tablet taken by mouth once a day for 28 days per cycle
16294291|NCT00685893|Behavioral|Education|We include information about end-of-life decision-making, communication skills, pain and symptom management, and withdrawal of life support. The primary methods of delivery will be a grand rounds lecture by one of the physician investigators and the viewing of an educational video for nurses and respiratory therapists. The content of the educational components will be structured to cover four topics: the principles of decision-making about end-of-life care in the ICU; communication with patients, families and the ICU team; pain and symptom management; and, the principles and practice of withdrawal of life support.
16294292|NCT00685893|Behavioral|Local Champions|We identify physicians, nurses and other clinicians from each hospital to serve as the local champions. The role of the local champions is to help implement the intervention and be a role model for end-of-life care in the ICU. Local champions participate in interactive education and training sessions with the investigators and the other local champions from their institution to discuss barriers to good end-of-life care at their location and to strategize about how to overcome those barriers.
16294293|NCT00685893|Behavioral|Institution Feedback|We provide feedback to the institution from the hospital specific family satisfaction data we collect. All feedback is presented as aggregated data for the institution without any personal identifiers.
16294294|NCT00685893|Behavioral|Academic Detailing|Study staff meet with ICU directors with 4 goals. The first goal is to familiarize the director with the educational content of the intervention. Secondly, the results of the family satisfaction data collected are shared without identifying information. The aggregated results of the other participating hospitals are disclosed, also without identifiers. Third, we elicit and discuss the institution-specific barriers to providing high quality end-of-life care in the ICU. Lastly, we hope that by educating the directors we can engage these clinical leaders to serve as role models in their institutions.
16294295|NCT00685893|Behavioral|Institutional Forms|We have developed a set of orders that encompass the various aspects of withdrawing life support from patients. Individual department directors at each hospital will decide if they want to implement a similar order form at their institution and whether they want to modify the form to fit their specific institutional needs. In addition to the order forms, we encourage hospitals to develop a family pamphlets and resources that can be given to families to provide education about the intensive care unit experience.
16294296|NCT00685880|Drug|Prolotherapy (10% dextrose solution)|Dextrose diluted with sterile water.
16294297|NCT00685880|Drug|Betamethasone|CELESTONE® SOLUSPAN® * (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
16294672|NCT00683319|Procedure|quality-of-life assessment|
16294298|NCT00685867|Other|Rapid molecular MRSA test|PCR-based rapid screening for MRSA carriage
16294299|NCT00685867|Behavioral|Hand hygiene promotion|"Promotion and monitoring of hand hygiene, with special emphasis on alcohol-based hand rubs and feedback of hand hygiene compliance
~Standard precautions (e.g. use of gloves for contacts with wounds and body fluids)
~Isolation precautions according to the hospitals' capacity and strategy
~Additional basic infection control interventions (if necessary)"
16294300|NCT00685854|Drug|Ranibizumab|
16294301|NCT00685841|Drug|Arformoterol tartrate inhalation solution|Arformoterol 50 mcg QD
16294302|NCT00685841|Drug|Arformoterol tartrate inhalation solution|Arformoterol 25 mcg BID
16294303|NCT00685841|Drug|Arformoterol tartrate inhalation solution|Arformoterol 15 mcg BID
16294304|NCT00685841|Drug|Salmeterol MDI|Salmeterol MDI 42 mcg BID
16294305|NCT00685841|Drug|Placebo|Placebo BID MDI
16294306|NCT00685828|Drug|imatinib mesylate|By mouth
16294307|NCT00685815|Drug|Ferric Carboxymaltose (FCM)|500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
16294308|NCT00685815|Drug|Placebo|250cc NS IV over one hour, once on Day 3, once on Day 4
16294309|NCT00685802|Drug|Cilostazol 50 mg Tablets|Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours
16294310|NCT00685802|Drug|Cilostazol (Pletal®) 50 mg Tablets|Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.
16294311|NCT00685789|Device|acupuncture, deqi|Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
16294312|NCT00685789|Device|acupuncture Non-manipulation|After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
16294313|NCT00685776|Drug|anacetrapib|Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
16294314|NCT00685776|Drug|Comparator: placebo|Participants will receive one placebo tablet once daily for 76 weeks.
16294315|NCT00685763|Radiation|Proton radiation and chemotherapy|"Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
~Chemotherapy:
~Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
16294316|NCT00685750|Procedure|Collection of tumor and blood samples|Samples will be collected before and after standard treatment
16294317|NCT00685737|Drug|1-MNA|Capsule
16294318|NCT00685737|Drug|Placebo|Capsule
16294319|NCT00685724|Behavioral|Motivational Enhancement Therapy (MET)|MET is a client-centered, directive form of therapy designed to enhance clients' intrinsic motivation to change.
16294320|NCT00685724|Behavioral|Cognitive-Behavioral Therapy (CBT)|In CBT, clients learn to modify their thoughts as well as their behaviors by increasing awareness of the relationship between thoughts, emotions, and actions.
16294321|NCT00685711|Biological|Cat-PAD|single, escalating dose intradermal and subcutaneous injections of Cat-PAD
16294322|NCT00685698|Drug|TG-873870 (Nemonoxacin)|750 mg
16294323|NCT00685685|Drug|Lovastatin 40 mg tablets|40 mg tablet administered after an overnight fast of at least 10 hours
16294324|NCT00685685|Drug|Lovastatin (Mevacor®) 40 mg Tablets|40 mg tablet administered after an overnight fast of at least 10 hours
16294325|NCT00685672|Drug|adrenalin|adrenalin 2 microgram pr ml placebo
16294326|NCT00685672|Drug|placebo|Saline instead of adrenaline in the epidural mixture
16294327|NCT00685659|Other|Intensive Outpatient Treatment|9 hours of group counseling per week for 2-3 months
16294328|NCT00685659|Other|Adaptive telephone-based counseling|In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included
16294329|NCT00685659|Other|Adaptive telephone-based counseling plus incentives|In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
16294330|NCT00685646|Drug|antiandrogen therapy|Up to 24 courses of therapy
16294331|NCT00685646|Drug|zoledronic acid|Up to 24 courses of therapy
16294332|NCT00685633|Drug|bicalutamide|Given orally
16294333|NCT00685633|Drug|enzastaurin hydrochloride|Given orally
16294334|NCT00685620|Behavioral|Reinforcement Based Treatment|3 group random assignment to receive standard care, recovery housing alone, or recovery housing plus behavioral treatment
16294335|NCT00685607|Drug|loperamide-simethicone|Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
16294336|NCT00685607|Drug|matching placebo|Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
16294337|NCT00685594|Drug|cholecalciferol|20.000 IU cholecalciferol per week for 5 years versus placebo
16294338|NCT00685594|Drug|Placebo|Placebo capsule once a week, identical to cholecalciferol capsule
16294339|NCT00685581|Dietary Supplement|Ruminant trans fatty acid enriched diet - lowest ratio|the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
16294340|NCT00685581|Dietary Supplement|Ruminant trans fatty acid enriched diet - medium ratio|the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed
16294341|NCT00685581|Dietary Supplement|Ruminant trans fatty acid enriched diet - highest ratio|the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed
16294342|NCT00685568|Drug|celecoxib|Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.
16294343|NCT00685568|Other|placebo|Orally, twice daily for 3 months
16294344|NCT00685555|Behavioral|Switch active lifestyles brought to you by MediaWise|The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity.
16295782|NCT00675064|Drug|Placebo|Placebo matching GSK369796
16294345|NCT00685555|Behavioral|Switch active lifestyles from MediaWise|1300 students (male and female) were recruited through two separate school districts in Lakeville, Minnesota and Cedar Rapids, Iowa. Informed consents went to all students who chose to participate. Demonstration and Control school were randomly selected. Baseline data was collected regarding physical activity, screen time, and nutrition, standard body measurements, and baseline data, and salivary cortisol levels were taken. Parent and teacher surveys were also conducted. After baseline selected demonstration sites and students were provided with information focused on improving healthy behaviors while the control sites served as matched comparison groups.
16294346|NCT00685542|Drug|diacerein|Diacerein 50mg bid
16294347|NCT00685542|Drug|placebo|placebo
16294348|NCT00685529|Drug|Racemic formoterol|12 µg of racemic formoterol fumarate BID
16294349|NCT00685529|Drug|Arformoterol tartrate inhalation solution|15 µg of nebulized arformoterol tartrate inhalation solution BID
16294350|NCT00685529|Drug|Racemic formoterol|24 µg of racemic formoterol fumarate BID
16294351|NCT00685516|Dietary Supplement|green tea|6 cups of green tea daily for 2-8 weeks
16294352|NCT00685516|Dietary Supplement|placebo|6 cups of water daily for 2-8 weeks
16294353|NCT00685516|Dietary Supplement|decaffeinated black tea|6 cups of decaffeinated black tea daily for 2-8 weeks
16294354|NCT00685503|Drug|Ranibizumab|
16294355|NCT00685490|Procedure|Vitrectomy w/o ILM peeling for macular edema with BRVO|Concurrent phacoemulsification and intraocular lens insertion in the capsular bag was performed, followed by PPV with separation of the posterior hyaloid from the optic disk and posterior retina with a posterior vitreous detachment was not present. Indocyanine green (ICG)-assisted peeling was performed in all consecutive patients between April 2000 and June 2003. 0.1% ICG solution was injected over the macular region. Immediately after application, the dye was washed out using a vitreous cutter. Repeated injection of ICG was not required. Triamcinolone acetonide (TA)-assisted ILM peeling was performed in all consecutive patients from July 2003 to November 2006.
16294356|NCT00685477|Drug|Experimental Sequence ABC|Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes
16294357|NCT00685477|Drug|Experimental Sequence ACB|Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes
16294358|NCT00685477|Drug|Experimental Sequence BAC|Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion
16294359|NCT00685477|Drug|Experimental Sequence BCA|Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion
16294360|NCT00685477|Drug|Experimental Sequence CAB|Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion
16294361|NCT00685477|Drug|Experimental Sequence CBA|Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion
16294362|NCT00685464|Drug|Abciximab|Intravenous.
16294363|NCT00685464|Drug|Abciximab|Intracoronary
16294364|NCT00685451|Behavioral|Cognitive Behavioral Therapy (CBT)|
16294365|NCT00685425|Drug|Levalbuterol HFA MDI|"levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each).
~Arm #A
~Xopenex HFA MDI"
16294366|NCT00685425|Drug|Racemic Albuterol|"racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg).
~Arm #B
~Proventil HFA MDI"
16294367|NCT00685412|Biological|VGX-3100|DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
16294368|NCT00685399|Drug|AIN457|AIN457 subcutaneous dose
16294369|NCT00685399|Drug|AIN 457|AIN457 low dose (i.v)
16294370|NCT00685399|Drug|AIN457|AIN457 high dose (i.v)
16294371|NCT00685386|Other|CO2 insufflation|The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
16294372|NCT00685386|Other|Room air insufflation|During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
16294373|NCT00685373|Drug|Canakinumab (ACZ885)|6 mL glass vial containing 150 mg lyophilized Canakinumab reconstituted with water for a subcutaneous injection every 8 weeks. Dosage based on body weight.
16294374|NCT00685360|Drug|OPC-67683|100 mg BID will be administered as two 50 mg tablets together with two matching placebo tablets for a total of four tablets administered twice a day (total daily dose of OPC-67683 is 200 mg) for 56 days. .
16294375|NCT00685360|Drug|OPC-67683|200 mg BID will be administered as four 50 mg tablets administered twice a day for (total daily dose of OPC-67683 is 400 mg) 56 days.
16294376|NCT00685360|Drug|Placebo|Placebo will be administered as four 50 mg tablets matching the OPC-67683 tablets administered twice a day for 56 days
16294377|NCT00685347|Drug|Levalbuterol HFA MDI|"levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each).
~Arm #A
~Xopenex HFA MDI"
16294378|NCT00685347|Drug|Racemic Albuterol|"racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg).
~Arm #B
~Proventil HFA MDI"
16294379|NCT00685334|Drug|Olanzapine|Participants will take olanzapine daily for 12 weeks.
16294380|NCT00685334|Drug|Aripiprazole|Participants will take aripiprazole daily for 12 weeks.
16294381|NCT00685321|Device|H1 deep TMS coil|20 daily deep rTMS treatment
16294382|NCT00685321|Device|Sham|inactive treatment
16294383|NCT00685308|Procedure|Stenting of atherosclerotic intracranial stenosis|"Patients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines.
~All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%."
16294384|NCT00685295|Drug|Fentanyl|Fentanyl rapid dissolving tablet 100mcg
16294385|NCT00685295|Drug|Lansoprazole|lansoprazole 15mg rapidly dissolving tablet
16294386|NCT00685295|Drug|Oxycodone|Oxycodone 5/325 mg tablet
16294506|NCT00684437|Behavioral|Questionnaire|Questionnaires taking 15-30 minutes to complete.
16294507|NCT00684424|Other|Non-Interventional Study|Observational Only
16294508|NCT00684411|Drug|Imatinib mesylate|
16294387|NCT00685282|Behavioral|Cognitive Behavioral Therapy|The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.
16294388|NCT00685269|Drug|Eszopiclone|Eszopiclone 3 mg QD
16294389|NCT00685269|Drug|Placebo|Placebo tablet
16294390|NCT00685256|Other|counseling intervention|subjects and parents will receive genetic counseling
16294391|NCT00685256|Other|educational intervention|subjects and parents will receive education re: genetic testing
16294392|NCT00685256|Other|survey administration|surveys will be administered to subjects and parents
16294393|NCT00685256|Behavioral|psychosocial assessment and care|psychosocial assessment and counseling will be provided
16294394|NCT00685256|Behavioral|supportive care|parents and children will be provided with supportive care
16294395|NCT00685243|Procedure|Laser treatment|Fraxel and pulsed dye laser
16294396|NCT00685230|Biological|Antivenin Centruroides (scorpion) equine immune F(ab)2|3 vials of Alacramyn reconstitued in 50 ml of normal saline as a IV infusion over 10 minutes.
16294397|NCT00685230|Other|Placebo|Placebo reconstituted in 50 ml of normal saline administered over 10 min
16294398|NCT00685217|Procedure|TVT Secur (Gynecare)|Sling device for stress urinary incontinence
16294399|NCT00685217|Procedure|TVT (Gynecare)|Sling procedure for stress urinary incontinence
16294400|NCT00685204|Drug|Milataxel|Milataxel is a liquid that is dosed orally at 60 mg/m2 on Day 1 of a 21 day cycle. If no toxicities of greater than Grade 1 severity occur, patients will receive 75 mg/m2 for the second and subsequent cycles.
16294401|NCT00685191|Drug|Salvage antiretroviral therapy including raltegravir|Initiation of raltegravir-including salvage antiretroviral therapy
16294402|NCT00685178|Drug|topiramate|"topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
~capsules are administered from week 4 through 25 of the trial"
16294403|NCT00685178|Behavioral|Contingency Reinforcement|monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
16294404|NCT00685178|Drug|placebo + NonCR|participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
16294405|NCT00685165|Drug|Primidone 50 mg Tablet|50 mg tablet administered after an overnight fast of at least 10 hours.
16294406|NCT00685165|Drug|Primidone (Mysoline®) 50 mg Tablet|50 mg tablet administered after an overnight fast of at least 10 hours.
16294407|NCT00685152|Device|Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)|6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.
16294408|NCT00685139|Drug|Zonisamide 100 mg Capsule|100 mg capsule administered after an overnight fast.
16294409|NCT00685139|Drug|Zonisamide (Zonegran®) 100 mg Capsule|100 mg capsule administered after an overnight fast.
16294410|NCT00685126|Drug|Levalbuterol HCl Inhalation Solution|Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight
16294411|NCT00685126|Drug|Levalbuterol HCl Inhalation Solution|Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
16294412|NCT00685126|Drug|Albuterol HCl Inhalation Solution|Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
16294413|NCT00685113|Drug|DR-3001|4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
16294414|NCT00685113|Drug|DR-3001|6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
16294415|NCT00685113|Drug|Placebo|Placebo vaginal ring inserted vaginally and replaced every 4 weeks
16294416|NCT00685100|Other|PDT plus intravitreal triamcinolone|PDT plus intravitreal triamcinolone
16294417|NCT00685074|Behavioral|Computer-based Motivational Interviewing|The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
16294418|NCT00685074|Behavioral|Time control|A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.
16294419|NCT00685061|Drug|Thymoglobulin|Induction
16294420|NCT00685061|Drug|Campath-1H|Induction
16294421|NCT00685061|Drug|Daclizumab|Induction
16294422|NCT00685048|Behavioral|10 minutes of psycho-education|Patients review with study therapist a brochure about types of gambling people engage in and relationships between gambling, drug use, moods, and legal problems.
16294423|NCT00685048|Behavioral|10 minutes of brief advice|Patients will review with study therapist a brochure and advice about problem gambling. It will also contain methods for reducing gambling.
16294424|NCT00685048|Behavioral|four 50-minute individual therapy sessions of MET & CBT|MET & CBT
16294425|NCT00685035|Device|HFCWC with higher pressure/variable-frequency settings|Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions.
16294426|NCT00685035|Device|HFCWC with lower pressure/mid-frequency settings|Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session.
16294427|NCT00685022|Drug|Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI|"Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
~Arm #A
~Xopenex HFA MDI, albuterol HFA MDI"
16294428|NCT00685022|Drug|Racemic Albuterol followed by levalbuterol HFA MDI|"Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
~Arm #B
~albuterol HFA MDI, Xopenex HFA MDI"
16294429|NCT00685009|Drug|Estrogen hormone therapy|Estrogen pill daily
16294430|NCT00685009|Drug|Estrogen plus progesterone hormone therapy|Estrogen plus progesterone hormone therapy pill (Prempro) daily
16294431|NCT00685009|Drug|Placebo|Placebo pill daily
16294432|NCT00684996|Drug|etaracizumab|Given IV
16294433|NCT00684996|Biological|bevacizumab|Given IV
16294434|NCT00684983|Drug|Capecitabine|Given PO
16294435|NCT00684983|Biological|Cixutumumab|Given IV
16294436|NCT00684983|Drug|Lapatinib Ditosylate|Given PO
16294437|NCT00684983|Other|Quality-of-Life Assessment|Ancillary studies
16294438|NCT00684970|Drug|Hamsa-1™ TL-118|Once daily Hamsa-1™ TL-118
16294439|NCT00684957|Drug|Recombinant Human Growth Hormone|300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
16294440|NCT00684957|Drug|Recombinant human IGF-1|30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
16294441|NCT00684944|Drug|TRx0014|Gelatin capsule, tid
16294442|NCT00684931|Other|Imaging|neuropsychological evaluation and Imaging with magnetic resonance (MRI)
16294443|NCT00684918|Drug|Obatoclax|A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.
16294444|NCT00684905|Drug|bicalutamide|
16294445|NCT00684905|Drug|leuprolide acetate|
16294446|NCT00684905|Procedure|adjuvant therapy|
16294447|NCT00684905|Procedure|neoadjuvant therapy|
16294448|NCT00684905|Procedure|quality-of-life assessment|
16294449|NCT00684905|Radiation|brachytherapy|
16294450|NCT00684892|Device|Chartis System|Assessment of airway flow and pressure
16294451|NCT00684866|Drug|Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI|(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
16294452|NCT00684866|Drug|Racemic Albuterol followed by levalbuterol HFA MDI|(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
16294453|NCT00684853|Drug|bevacizumab|1.25 mg of bevacizumab intravitreal
16294454|NCT00684853|Drug|vetaporfin|full fluence of vetaporfin
16294455|NCT00684827|Drug|Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI|"Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
~Arm #A
~Xopenex HFA MDI, Pirbuterol HFA MDI"
16294456|NCT00684827|Drug|Racemic Albuterol followed by levalbuterol HFA MDI|"Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
~Arm #B
~Pirbuterol HFA MDI, Xopenex HFA MDI"
16294457|NCT00684814|Drug|Zolpidem Tartrate 10 mg tablet|10 mg tablet administered after an overnight fast of at least 10 hours
16294458|NCT00684814|Drug|Zolpidem Tartrate 10 mg tablet (Ambien®)|10 mg tablet administered after an overnight fast of at least 10 hours
16294459|NCT00684801|Other|questionnaire administration|Patients complete questionnaires.
16294460|NCT00684801|Procedure|quality-of-life assessment|Patients undergo quality-of-life assessments.
16294461|NCT00684788|Combination Product|employment-based reinforcement|"Participants in the Work Plus Naltrexone Contingency condition were required to take scheduled doses of depot naltrexone to work and earn wages."
16294462|NCT00684775|Combination Product|Work Plus Naltrexone Contingency|"Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
16294463|NCT00684762|Drug|Cilostazol 100 mg Tablets|Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours
16294464|NCT00684762|Drug|Cilostazol (Pletal®) 100 mg Tablets|Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.
16294465|NCT00684723|Drug|Lovastatin 40 mg Tablets|40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast
16294466|NCT00684723|Drug|Lovastatin (Mevacor®) 40 mg Tablets|40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast
16294467|NCT00684710|Drug|PAZ-417|
16294468|NCT00684710|Drug|Placebo|
16294469|NCT00684697|Dietary Supplement|iron|High, intermediate and low iron dosage orally for 2 months
16294470|NCT00684684|Device|Chartis System|Assessment of airway flow and pressure
16294471|NCT00684671|Biological|Twinrix|Intramuscular injection, single dose in left deltoid.
16294472|NCT00684671|Biological|Engerix-B|Intramuscular injection, single dose in left deltoid.
16294473|NCT00684671|Biological|Havrix|Intramuscular injection, single dose in right deltoid.
16294474|NCT00684671|Biological|HBVAXPRO|Intramuscular injection, single dose in the left deltoid.
16294475|NCT00684671|Biological|Vaqta|Intramuscular injection, single dose in right deltoid.
16294476|NCT00684658|Behavioral|TeenCope|Teencope consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist
16294477|NCT00684658|Behavioral|Managing Diabetes|Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. As with the TeenCope program, each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth complete educational sessions independently over 5 weeks. There is no online discussion board or peer interaction.
16294478|NCT00684645|Drug|SUTENT|SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.
16294479|NCT00684632|Drug|Placebo|Placebo
16294480|NCT00684632|Drug|KW-2246 (fentanyl citrate)|KW-2246 (fentanyl citrate)
16294481|NCT00684619|Drug|Nelarabine|1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
16294482|NCT00684606|Drug|Oxytocin IV|5 miu/1000ml Glu/Saline
16294483|NCT00684593|Drug|Navarixin 10 mg|Navarixin capsules orally, once daily for 28 days.
16294484|NCT00684593|Other|Placebo|Matching placebo capsules to Navarixin orally, once daily for 28 days.
16294485|NCT00684580|Other|Data Collection|Continuing review of outcomes and late toxicities
16294486|NCT00684567|Radiation|Radiotherapy|Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.
16294487|NCT00684567|Drug|Temozolomide|During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.
16294488|NCT00684554|Drug|Buprenorphine|Dose is determined according to the participants' individual need.
16294489|NCT00684541|Behavioral|Interpretation Modification Program|"The IMP protocol includes twelve 30-min sessions delivered over a 6-week period. Each session will comprise 220 trials. In each trial, participants will first see either a non-threat or a threat (e.g. graceful or clumsy) word on the computer screen. They will then see an ambiguous sentence (e.g. You dance at the party) and will be asked to indicate if the word and sentence were related by pressing a corresponding key. Participants will receive positive feedback (i.e., You are correct!) when they endorse a non-threat interpretation or reject a threat interpretation of an ambiguous sentence. Participants will receive negative feedback (i.e., You are incorrect.) when they endorse a threat interpretation or reject a non-threat interpretation of an ambiguous sentence."
16294490|NCT00684541|Behavioral|Interpretation Control Condition|Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation.
16294491|NCT00684528|Drug|Metformin 1500 mg daily|500 mg thrice daily
16294492|NCT00684528|Drug|Metformin + Janufer (Janumet)|Titration up to 1500/150 mg daily
16294493|NCT00684515|Drug|Vorapaxar 2.5 mg|Oral tablets; once daily for 60 days.
16294494|NCT00684515|Drug|Vorapaxar 1 mg|Oral tablets; once daily for 60 days
16294495|NCT00684515|Drug|Placebo|oral tablets; once daily for 60 days
16294496|NCT00684515|Drug|Aspirin 75-150 mg|oral tablets; once daily for 60 days
16294497|NCT00684502|Drug|AZD2066|Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
16294498|NCT00684502|Drug|Placebo|Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
16294499|NCT00684489|Drug|clinical hypertension specialist-no specific med. Any anti-hypertension meds.|assignment to a clinical hypertension specialist. Drugs used were hypertension medications were: chlorothiazide, hydrochlorothiazide, polythiazide indapamide, metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene, eplerenone, spironolactone, atenolol, betaxolol, bisoprolol, metoprolol, nadolol, propranolol, timolol, acebutolol, penbutolol pindolol, carvedilol, labetalol, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, diltiazem, dilacor, ditiazem, verapamil, amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, doxazosin, prazosin, terazosin, clonidine, clonidine patch, methyldopa, reserpine, guanfacine, hydralazine, minoxidil.
16294500|NCT00684489|Drug|renin guided therapeutics-no specific med. Any anti-hypertensive med.|renin guided therapeutics-chlorothiazide, chlorthalidone, hydrochlorothiazide, polythiazide, indapamide, metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene, eplerenone, spironolactone, atenolol, betaxolol, bisoprolol, metoprolol, nadolol, propranolol, timolol, acebutolol, penbutolol, pindolol, carvedilol, labetalol, benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, diltiazem, dilacor, verapamil, amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, doxazosin, prazosin, terazosin, chlonidine, methyldopa, reserpine, guanfacine, hydralazine, minoxidil.
16294501|NCT00684476|Drug|venom immunotherapy|
16294502|NCT00684463|Drug|Palonosetron|0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
16294503|NCT00684450|Procedure|Titration protamine|10. Study group: celite ACT will be performed every 3 minutes during protamine infusion until ACT values suggest reach of a plateau (defined as 2 similar ACT values, within 10% variability, and ACT ≤ to 160 seconds.), time at which infusion will be stopped. 2cc of blood is required per ACT test, for a maximum total of 10cc.
16294504|NCT00684450|Drug|Standard administration of protamine|1.3 mg of Protamine for 100u héparine
16294505|NCT00684437|Behavioral|Focus Group|Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
16294509|NCT00684385|Drug|ZD1839|250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration.
16294510|NCT00684372|Drug|leflunomide|"Screening: If BK viremia (BK PCR >10 000 copies/ml in serum) i. Reduced immunosuppression
~MMF / AZA withdrawal
~CNI reduction
~Tacrolimus 5 ng/ml in serum
~Cyclosporin 100 ng/ml in serum
~Prednisolone to maintenance level
~If effective => continue
~Stable renal function (P-Krea)
~>50% reduction in PCR (copies/ml) at 4 weeks after diagnosis
~Negative PCR at > 3 months after diagnosis
~If failure => add leflunomide
~Deteriorating renal function (P-Krea) and positive PAD = BK nephropathy
~<50% reduction in PCR at 4 weeks after diagnosis
~Positive PCR at >3 months after diagnosis
~Leflunomide dosing:
~ii. Loading dose of 100 mgx1 PO daily for 5 days can be used or the patient can be directly started on iii. Maintenance dose (from day 1 or day 6)
~Starting at 20 mgx1 PO daily
~Thereafter adjusted between approximately 20-60 mgx1 PO daily according to serum levels of A77 1726 and the clinical situation a. Recommended level of A77 1726 >40 ug/ml"
16294511|NCT00684346|Other|18-FDG|The administered intravenous dose of 18-FDG is 0.14mCi/kg up to a maximum of 10mCi before each PET imaging scan is performed.
16294512|NCT00684333|Device|painless subcutaneous injection by EZ-Ject Injector|EZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system
16294513|NCT00684320|Behavioral|Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
16294514|NCT00684320|Behavioral|Placebo Condition|The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
16294515|NCT00684307|Drug|AZD0837|ER tablet, PO, once daily for a period of 3-9 months.
16294516|NCT00684307|Drug|Vitamin-K antagonist at INR 2-3|Tablet, PO for a period of 3-9 months.
16294517|NCT00684307|Drug|AZD0837|ER tablet, PO, twice daily for a period of 3-9 months
16294518|NCT00684294|Biological|TGFβ2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine|Patients with solid tumors will receive TAG Vaccine 1 x 10^7 cells/ injection or TAG Vaccine 2.5 X 10^7 cells/injection once a month for up to 12 doses via intradermal injection as long as sufficient material is available. Selection of cohort is dependent on the amount of tumor cell yield following harvest and processing.
16294519|NCT00684281|Other|Neurological and neuropsychological consultation, MRI|Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
16294520|NCT00684281|Other|Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA|Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36
16294521|NCT00684268|Drug|Silibinin|"comparison of different dosing schedule of Silibinin infusions (20 mg/kg/d infused over 2 hours) A: 3x5days B: 14 days C: 21 days D: 28 days
~sequential the infusion duration will be shortened - 2 hours, then 1 hr and then 1/2 hr/infusion"
16294522|NCT00684268|Drug|Silibinin|20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
16294523|NCT00684255|Procedure|Reduced Intensity Allogeneic Transplant|Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).
16294524|NCT00684255|Drug|Fludarabine|Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2
16294525|NCT00684255|Drug|Busulfan|Busulfan 3.2 mg/kg Days _8, -7, -6, -5
16294526|NCT00684255|Drug|Campath|Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2
16294527|NCT00684242|Drug|Lenalidomide|10 mg by mouth daily
16294528|NCT00684229|Procedure|Regional anesthesia and analgesia|Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
16294529|NCT00684229|Drug|general anesthesia followed by opioid analgesia|sevoflurane general anesthesia and postoperative opioid analgesia
16294530|NCT00684216|Drug|capecitabine|200 mg, BID, PO, QD until progression of disease
16294531|NCT00684216|Drug|hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)|either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease
16294532|NCT00684203|Drug|Vorapaxar|Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
16294533|NCT00684203|Drug|Placebo|Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days
16294534|NCT00684203|Drug|Aspirin|Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days.
16294535|NCT00684203|Drug|Clopidogrel|100 mg two or three times daily for 60 days.
16294536|NCT00684190|Drug|AZD3355|150 mg bid, oral, 7 days
16294537|NCT00684190|Drug|Esomeprazole|40 mg od, oral, 7 days
16294538|NCT00684177|Drug|Retapamulin Ointment, 1%|Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.
16294539|NCT00684177|Drug|Placebo ointment|Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.
16294540|NCT00684164|Drug|Conivaptan|20mg bolus over 30 min, and then as a 20mg infusion over 24 hours for up to 4 days
16294541|NCT00684164|Other|D5|Volume loading dose of D5 followed by an infusion of D5 over 24 hours for up to 4 days - or until the study endpoint of sodium ≥135mEq/L is reached.
16294542|NCT00684138|Device|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens|Intraocular Lens
16294543|NCT00684138|Device|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens|Intraocular Lens
16294544|NCT00684125|Device|Blake Drains (Blake drain, Ethicon USA)|19F Blake drain located in the posterior pericardial cavity
16294545|NCT00684125|Device|Standard mediastinal drainage|Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
16294546|NCT00684112|Drug|Gabapentin|Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.
16294547|NCT00684112|Drug|Placebo|Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.
16294548|NCT00684099|Drug|Docetaxel|Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
16294549|NCT00684099|Drug|Pemetrexed|Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
16294550|NCT00684086|Behavioral|Diabetes Self Management Program|
16294551|NCT00684073|Drug|buprenorphine|2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study
16294552|NCT00684073|Drug|buprenorphine/naloxone|2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study
16294553|NCT00684060|Biological|Adult stem cells|One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution
16294554|NCT00684060|Biological|Placebo|One time infusion of 30 ml of HSA (5%)
16294555|NCT00684047|Biological|FS Grifols|Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
16294556|NCT00684047|Biological|FS Grifols|Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
16294557|NCT00684047|Procedure|Manual Compression|Manual Compression. Primary Part (II)
16294558|NCT00684034|Other|Sampling of blood|A sampling of blood will be made
16294559|NCT00684034|Other|Sampling of blood|A sampling of bood will be made before the dialysis
16294560|NCT00684034|Other|Sampling of blood|A sampling of blood will be made.
16294561|NCT00684021|Biological|Adult stem cells|One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution
16294562|NCT00684021|Biological|Placebo|One time infusion of 30 ml of HSA (5%)
16294563|NCT00684008|Drug|CYT107 - Recombinant glycosylated human interleukin 7.|Patients will be treated with CYT107 60 to 210 days post transplantation, in 3 successive cohorts of 3 patients. Escalating doses of CYT107 will be given to successive cohorts. Patients will receive 1 dose of CYT107 by the subcutaneous route, once a week for 3 weeks. Dose level 1: 10 mcg/kg/dose for 3 doses; Dose level II: 20 mcg/kg/dose for 3 doses; Dose level III: 30 mcg/kg/dose for 3 doses. Only 1 treatment course for this initial study.
16294564|NCT00684008|Drug|rhIL-7 (CYT107)|10, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route.
16294565|NCT00683995|Drug|KW-2246 (fentanyl citrate)|KW-2246 (fentanyl citrate)
16294566|NCT00683982|Drug|Nitazoxanide|Nitazoxanide 15mg/Kg/day twice day for 3 days
16294567|NCT00683982|Drug|Probiotic mix preparation|Probiotic preparation 1 gram twice a day for 5 days
16294568|NCT00683982|Other|Oral hydration solutions|Oral hydration solutions as needed
16294569|NCT00683969|Drug|mycophenolate mofetil (CellCept)|1g bid for 36 weeks
16294570|NCT00683969|Drug|placebo|po bid for 36 weeks
16294571|NCT00683956|Device|ReinLoop control software for patient-specific induction and maintenance of anesthesia|
16294572|NCT00683956|Drug|Propofol|
16294573|NCT00683943|Drug|Lithium Carbonate|
16294574|NCT00683930|Drug|Mycophenolate Mofetil 2 g/Day|Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
16294575|NCT00683930|Drug|Mycophenolate Mofetil (MMF) 3 g/Day|Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
16294576|NCT00683930|Drug|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
16294577|NCT00683917|Drug|Proellex 25 mg|Proellex 25 mg, 1 capsule daily for 4 months
16294578|NCT00683917|Drug|Proellex 50 mg|Proellex 50 mg, 2 capsules daily for 4 months
16294579|NCT00683917|Drug|Lupron Depot|Lupron 3.75 mg monthly intramuscular injections for 4 months
16294580|NCT00683904|Drug|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL|On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
16294581|NCT00683904|Drug|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL|After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
16294582|NCT00683891|Drug|FazaClo (clozapine, USP) ODT|
16294583|NCT00683878|Drug|Dapagliflozin|Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
16294584|NCT00683878|Drug|Dapagliflozin|Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
16294585|NCT00683878|Drug|Placebo matching Dapagliflozin|Tablets, Oral, 0 mg, once daily, up to 48 weeks
16294586|NCT00683878|Drug|Thiazolidinedione (Pioglitazone)|Tablets, ≥ 30 mg, Once daily, up to 48 weeks
16294587|NCT00683865|Drug|Ofloxacin|Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
16294588|NCT00683865|Drug|Avelox (Moxifloxacin, BAY12-8039)|Moxifloxacin 400 mg po od for 14 days
16294589|NCT00683852|Drug|Aripiprazole 5mg|Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days)
16294590|NCT00683852|Drug|Aripiprazole 2mg|For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days)
16294591|NCT00683852|Drug|Placebo|for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)
16294624|NCT00683579|Drug|Early Treatment with HAART|HAART with possibility of de-intensification
16294592|NCT00683839|Behavioral|Brief tobacco counseling|Public health dental professionals provide brief counseling during routine visits based on the Clinical Practice Guidelines 5 As (Ask, Advise, Assess, Assist, Arrange), including offering free Nicotine Replacement Therapy and referral to a Tobacco Quit Line. Pharmacologic: nicotine patch or lozenge maximum 12 week course.
16294593|NCT00683826|Dietary Supplement|L-Leucine 8gr|Supplementation in the form of a liquid meal (premixed leucine powder solutions with flavor made by the Bionutrition Unit of the Irving Insitute for Clinical and Translational Research (IICTR)). Dosing of leucine will be a combination of 2 ounces of liquid per 1 gm of leucine. L-leucine was purchased (FCC quality) from Spectrum Chemical,California. Certificate of analysis enclosed (99.89% leucine).Liquid meal preparation: Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. Each drink will be individually prepared with 8 grams of leucine.
16294594|NCT00683826|Other|Liquid meal|Liquid meal preparation (contents): Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. The placebo group will have the same drinks listed above with no leucine incorporated.
16294595|NCT00683826|Dietary Supplement|L-Leucine 4g|Supplementation in the form of a liquid meal (premixed leucine powder solutions with flavor made by the Bionutrition Unit of the Irving Insitute for Clinical and Translational Research (IICTR)). Dosing of leucine will be a combination of 2 ounces of liquid per 1 gm of leucine. L-leucine was purchased (FCC quality) from Spectrum Chemical,California. Certificate of analysis enclosed (99.89% leucine).Liquid meal preparation: Grape juice and crystal light mixes will be used for the preparation of liquid meals that will be given to each participant each week. Participants will consume two 8 ounce drinks (packaged in two 10 ounce bottles) per day. Each drink will be individually prepared with 4 grams of leucine.
16294596|NCT00683813|Behavioral|vCRP|The vCRP includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. VCRP patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. After the 4 month intervention, patients will be discharged into the care of their primary care physician.
16294597|NCT00683800|Drug|desvenlafaxine succinate (DVS) SR|Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
16294598|NCT00683800|Drug|Placebo|Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.
16294599|NCT00683787|Drug|docetaxel|Given IV once every 3 weeks
16294600|NCT00683787|Drug|vandetanib|Oral vandetanib once daily
16294601|NCT00683774|Drug|diazoxide|100mg orally three times per day for 10 days
16294602|NCT00683761|Drug|131I-TM601|In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.
16294603|NCT00683735|Drug|Sitagliptin|100 mg once daily in the morning
16294604|NCT00683735|Drug|Metformin|up to 2000 mg/day
16294605|NCT00683735|Drug|Placebo|500mg 1-0-0-0
16294606|NCT00683735|Drug|Placebo|100mg 1-0-0-0
16294607|NCT00683722|Drug|PROCHYMAL™|Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
16294608|NCT00683722|Drug|Placebo|Intravenous infusion of excipient of PROCHYMAL™
16294609|NCT00683709|Behavioral|Counselling as Usual|5 - 20 minutes, about the effects of clozapine on body weight, appetite, blood sugar and fats such as cholesterol and triglycerides in the blood, and how these might affect your health in the future.
16294610|NCT00683709|Behavioral|CBT|45 - 60 minutes individual treatment sessions focused on nutrition, exercise and weight control and will occur weekly for 4 weeks. After this, 10 group sessions focused on weight reduction will be held every 2 weeks. This will be followed by 6 group sessions focused on weight maintenance held every 2 weeks.
16294611|NCT00683696|Device|Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)|All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
16294612|NCT00683683|Behavioral|Knowledge Translation|The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes.
16294613|NCT00683670|Drug|cyclophosphamide|
16294614|NCT00683670|Biological|Mature dendritic cell vaccine|
16294615|NCT00683657|Drug|Saxagliptin|Tablets, Oral, 5mg, once daily, 4 weeks
16294616|NCT00683657|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 4 weeks
16294617|NCT00683644|Drug|Zinc|Zinc taken once daily
16294618|NCT00683644|Drug|Placebo oral capsule|Placebo capsules taken once daily
16294619|NCT00683631|Radiation|TheraSphere HUD|TheraSphere is FDA approved under a Humanitarian Use Device. It is considered a brachytherapy device that delivers intra-arterial radiation therapy using yttrium-90 microspheres directly to liver tumors.
16294620|NCT00683618|Drug|Rosuvastatin|Capsule/Tablet, oral, qd, 6 or 12 weeks
16294621|NCT00683618|Drug|Atorvastatin|Capsule/Tablet, 10mg, oral, qd, 6 weeks
16294622|NCT00683592|Drug|vilazodone|titration to 40 mg tablets qd (once a day) for 8 weeks
16294623|NCT00683592|Drug|placebo|placebo
16294625|NCT00683579|Other|No treatment|No treatment. For group 2, participants do not yet meet DHHS guidelines. For group 4, treatment is not initiated due to unwillingness or providers' expectation of poor adherence.
16294626|NCT00683579|Drug|HAART Treatment - standard care|Initiation of HAART per DHHS guidelines, i.e. starting treatment and CD4+ T cells less than 350 cells/mm3 or HIV RNA >100,000 copies/ml
16294627|NCT00683566|Procedure|electrostimulation|Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks
16294628|NCT00683553|Drug|I5NP|Single IV injection of experimental drug given in escalated doses at 0.5, 1.5, 5.0 and 10 mg/kg doses to different patients
16294629|NCT00683553|Drug|Placebo|Single IV injection of saline
16294630|NCT00683527|Drug|Elemental iron|Iron in the dose of 3-4 mg/kg/day (of elemental iron) PO once daily mixed with expressed breast milk from 14 days of life till the end of study period
16294631|NCT00683514|Drug|Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)|"q 28 days :
~50 mg/m2 oral vinorelbine d1, d8, d15
~20 mg/m2/d cisplatin from d1 to d4"
16294632|NCT00683514|Drug|Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)|"q 21 days :
~60 mg/m2 oral vinorelbine d1,d8 for cycle 1 or 80 mg/m2 oral vinorelbine d1,d8 for cycle 2
~80 mg/m2 cisplatin d1"
16294633|NCT00683501|Drug|DNB-001|four dosages of DNB-001, one placebo dosage
16294634|NCT00683488|Behavioral|Focus Group|Focus group using and collecting feedback on the CBT/CM intervention.
16294635|NCT00683488|Behavioral|First Intervention Trial|"Intervention will comprise of approximately 15 weekly sessions.
~Exit interviews at the end of each session will assess acceptability, feasibility, and relevance of the intervention.
~Quantitative assessment (ACASI) pre and post intervention will document immediate changes in substance use, sexual risk, and adherence to medical care.
~Qualitative feedback from interviews with mental health providers and study coordinators will address acceptability and feasibility."
16294636|NCT00683488|Behavioral|Intervention Trial 2|Evaluations/assessments will be similar to those involved for the first intervention trial. Study participants will return for a follow-up visit 3 months after the last intervention session to complete the ACASI.
16294637|NCT00683475|Biological|IMC-A12|IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.
16294638|NCT00683475|Drug|Mitoxantrone|Mitoxantrone is to be administered as an I.V. infusion, at 12 milligrams/square meter (mg/m^2) over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m^2) or until there is evidence of disease progression, death, or intolerable toxicity.
16294639|NCT00683475|Drug|Prednisone|Prednisone (5 mg) is to be self-administered PO BID, each day of the 21-day cycle.
16294640|NCT00683475|Biological|IMC-1121B (ramucirumab)|IMC-1121B (ramucirumab) is to be administered as an intravenous (IV) infusion, 6 milligrams/kilogram (mg/kg) over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. Ramucirumab treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.
16294641|NCT00683462|Drug|Placebo|
16294642|NCT00683462|Drug|AZD3480|Capsules 5 mg/day (once a day) for 2 weeks
16294643|NCT00683462|Drug|AZD3480|Capsules 50 mg/day (once a day) for 2 weeks
16294644|NCT00683449|Drug|Dose Group 1|IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg
16294645|NCT00683449|Drug|MN-221 placebo|i.v. infusion of placebo for 15 minutes
16294646|NCT00683449|Drug|Dose Group 2|i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg)
16294647|NCT00683449|Drug|Dose Group 3|i.v. infusion of MN-221 16 mcg/min for 15 minutes followed by 8 mcg/min for 105 minutes (total dose = 1,080 mcg)
16294648|NCT00683436|Drug|Adipiplon|bilayer tablets 6 mg
16294649|NCT00683436|Drug|Placebo|Placebo
16294650|NCT00683436|Drug|Ambien CR|Ambien CR 12.5 mg
16294651|NCT00683436|Drug|Adipiplon|bilayer tablets 9 mg
16294652|NCT00683423|Drug|BMS-741672|Tablets, Oral, 100 mg, once daily, 3 weeks
16294653|NCT00683423|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
16294654|NCT00683410|Biological|Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)|
16294655|NCT00683397|Other|Blood sampling|Screening of thrombophilia
16294656|NCT00683384|Drug|Etanercept (Enbrel)|
16294657|NCT00683371|Procedure|Specimen collection|10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery. The sinus mucosa, sinus mucus and a saline lavage will be collected. The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
16294658|NCT00683371|Procedure|Specimen collection|10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery. The sinus mucosa, sinus mucus and a saline lavage will be collected. The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
16294659|NCT00683358|Biological|VEGFR1-A24-1084 (SYGVLLWEI)|HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.
16294660|NCT00683345|Drug|Anakinra|Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
16294661|NCT00683345|Drug|Placebo|Saline 0.67 ml daily subcutaneously as placebo drug.
16294662|NCT00683332|Drug|Tigecycline (Tygacil)|This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).
16294663|NCT00683319|Drug|carboplatin|
16294664|NCT00683319|Drug|cisplatin|
16294665|NCT00683319|Drug|cyclophosphamide|
16294666|NCT00683319|Drug|methotrexate|
16294667|NCT00683319|Drug|vincristine sulfate|
16294668|NCT00683319|Procedure|adjuvant therapy|
16294669|NCT00683319|Procedure|cognitive assessment|
16294670|NCT00683319|Procedure|magnetic resonance imaging|
16294671|NCT00683319|Procedure|magnetic resonance spectroscopic imaging|
16294673|NCT00683306|Drug|ZD1839 (Iressa)|Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.
16294674|NCT00683293|Procedure|Conventional Laparoscopic Hysterectomy|Removal of uterus via standard laparoscopic techniques
16294675|NCT00683293|Procedure|Robot-assisted (Da Vinci®) laparoscopic hysterectomy|Removal of uterus by robot-assisted laparoscopic technique
16294676|NCT00683280|Behavioral|contingency management|Prize-based contingency management, with the opportunity to earn prizes for expired carbon monoxide levels reading 6ppm or less and urinary cotinine levels reading 30ng/ml or less for 4 weeks.
16294677|NCT00683280|Other|Standard of Care|varenicline (smoking cessation medication) 0.5mg po daily Days 1-3, 0.5mg po twice daily Days 4-7, 1.0 mg po twice daily Days 8-84.
16294678|NCT00683280|Other|Standard of Care|Twice weekly brief counseling based on public health service guidelines for quitting smoking.
16294679|NCT00683267|Drug|4975, highly purified capsaicin|One dose administered by direct instillation into the surgical site
16294680|NCT00683267|Drug|Placebo|One dose administered by direct instillation into the surgical site
16294681|NCT00683241|Biological|DCVac-L|Subjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28
16294682|NCT00683228|Behavioral|Counseling|Consecutive newborns exposed to secondhand smoke will be recruited into the study and randomized to have parents receive or not receive specific counselling on harmful effects of SHS exposure. Urine cotinine will be measured at several points during the study for each group
16294683|NCT00683202|Drug|Acetylsalicylic acid|Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
16294684|NCT00683202|Drug|Placebo|Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
16294685|NCT00683189|Drug|Warfarin|Oral administration (QD), variable dosage: patients will undergo blood test for PT/INR at baseline and afterwards, at weekly bases for 4 weeks. The INR will be kept in a safe range of 2-2.5
16294686|NCT00683176|Drug|Choline Fenofibrate|135 mg
16294687|NCT00683176|Drug|Placebo|Placebo
16294688|NCT00683163|Drug|PTH(1-84)|1.4 mg injected subcutaneously (in the abdomen) daily
16294689|NCT00683163|Drug|Ibandronate|150mg by mouth once monthly
16294690|NCT00683163|Other|Placebo injection|Daily injections as placebo for PTS 1-84
16294691|NCT00683163|Other|Placebo pills|Monthly pills as placebo for oral ibandronate
16294692|NCT00683150|Other|Endothelial Function Test|Endothelial function tests performed within 20 days before surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery.
16294693|NCT00683137|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
16294694|NCT00683137|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
16294695|NCT00683137|Drug|valdecoxib/placebo|valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5
16294696|NCT00683124|Drug|Losartan and nebivolol|"Nebivolol is administered orally as pills. It is given preferentially once a day in the morning or, if not well tolerated because of hypotension, the total daily dosage is given in two administrations.
~Losartan is administered orally as pills. It is given preferentially once a day or, if not well tolerated because of hypotension, the total daily dosage is given in two administrations"
16294697|NCT00683124|Drug|Losartan|Losartan is administered orally as pills. It is given preferentially once a day or, if not well tolerated because of hypotension, the total daily dosage is given in two administrations
16294698|NCT00683124|Drug|Nebivolol|Nebivolol is administered orally as pills. It is given preferentially once a day in the morning or, if not well tolerated because of hypotension, the total daily dosage is given in two administrations
16294699|NCT00683111|Drug|esomeprazole 20 mg daily|oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
16294700|NCT00683111|Drug|famotidine 40 mg daily|oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
16294701|NCT00683085|Biological|HLA-A*02:01-restricted VEGFR1-derived peptide vaccination|VEGFR1-derived HLA-A*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the feasibility and efficacy of this type of peptide.
16294702|NCT00683059|Drug|Paclitaxel|total dose (mg) = body surface area in m2 x study dose (mg/m2) to be injected into a vein once every 3 weeks over 18 months.
16294703|NCT00683046|Drug|Fludarabine|Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
16294704|NCT00683046|Drug|Melphalan|Melphalan 140 mg/m2 IV on day -2.
16294705|NCT00683046|Drug|Stem cells|Stem cell infusion on day 0.
16294706|NCT00683046|Drug|Campath|Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
16294707|NCT00683033|Behavioral|Contingency Management|For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL).
16294708|NCT00683033|Behavioral|Brief smoking cessation counseling|For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.
16294753|NCT00682669|Behavioral|MBSR|A mindfulness-based stress reduction (MBSR) program consisting of an 8-week, 9-session intervention based on systematic and intensive training in mindfulness meditation and mindful hatha yoga and their application to every day life.
16294709|NCT00683020|Behavioral|ATSM Intervention|"The ATSM system is designed to promote the efficiency of a care manager by having her focus outreach phone calls to patients who, by virtue of their responses to the ATSM system, report a need for further support. The purpose of these call-backs is to have the care manager directly engage patients in setting goals and developing an action plan to improve their overall health. The care manager is trained to perform motivational interviewing, assess and overcome barriers to health communication.
~For some patients, the ATSM system as described above is augmented by additional phone communications from care manager to patient, triggered by health IT derived from 2 additional data sources: SFHP pharmacy claims data and CHNSF diabetes registry. The latter combines clinical data (labs and blood pressure). Based on clinical criteria, the ATSM system will alert care manager to make additional calls to patients."
16294710|NCT00683007|Other|Volume resuscitation (Crystalloid)|Crystalloid vs. Hypertonic Saline Solution
16294711|NCT00683007|Other|Volume resuscitation (Hypertonic Saline Solution)|Crystalloid vs. Hypertonic Saline Solution
16294712|NCT00682994|Behavioral|Interview|Interview lasting about 5-10 minutes.
16294713|NCT00682994|Behavioral|Questionnaire|Questionnaires taking 20-30 minutes to complete.
16294714|NCT00682981|Drug|Obatoclax|IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
16294715|NCT00682981|Drug|Carboplatin/etoposide|Carboplatin/etoposide combination
16294716|NCT00682955|Drug|Zinc Sulphate|20 mg per day, Zinc Sulphate tablet has been given to subjects.
16294717|NCT00682955|Drug|Zinc Sulphate|20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
16294718|NCT00682929|Drug|Inhaled Cannabis|Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks.
16294719|NCT00682929|Drug|Oral THC|Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks.
16294720|NCT00682929|Drug|Oral Placebo|Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.
16294721|NCT00682929|Drug|Inhaled placebo|Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.
16294722|NCT00682916|Dietary Supplement|Y288|Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
16294723|NCT00682916|Dietary Supplement|Y288|Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal
16294724|NCT00682903|Device|GuardianR|As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.
16294725|NCT00682890|Drug|placebo|placebo birth control pill daily
16294726|NCT00682890|Drug|metformin|2000 mg per day for 3 months daily birth control pill
16294727|NCT00682851|Device|OSOM Trichomonas Rapid Test|Rapid test run using vaginal discharge collected via a cotton swab
16294728|NCT00682851|Device|OSOM BVBlue Test|Rapid test run using vaginal discharge collected using a cotton swab
16294729|NCT00682838|Behavioral|Self-management|Self-management
16294730|NCT00682838|Behavioral|Telemonitored care|Telemonitored care
16294731|NCT00682825|Behavioral|Bispectral index protocol|Aim to titrate anesthesia to maintain BIS between 40 and 60.
16294732|NCT00682825|Behavioral|End tidal anesthetic gas-guided|Aim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents
16294733|NCT00682812|Other|2 cervical takings and 2 sampling of blood|"2 cervical takings
~2 sampling of blood before and after the total hysterectomy"
16294734|NCT00682812|Other|2 cervical takings and 2 sampling of blood|"cervical taking during the cervical conization
~2 sampling of blood before and after the intervention"
16294735|NCT00682812|Other|2 cervical takings and 2 sampling of blood|"cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation
~2 sampling of blood before and after the intervention"
16294736|NCT00682786|Drug|5FU|
16294737|NCT00682786|Radiation|Radiation|
16294738|NCT00682786|Procedure|Surgery of resectable lesions|
16294739|NCT00682786|Drug|Irinotecan|
16294740|NCT00682773|Other|SBAR|Educational intervention for nursing staff on effective communication regarding warfarin treatment/care; use of SBAR communication forms.
16294741|NCT00682760|Drug|Korean Botulinum toxin type A (KbtxA) and Botox injection|Each vial of Botox and KbtxA contained 100 U of BTX-A in a sterile vacuum-derived form without preservatives. Each vial of KbtxA was identical to the placebo (Botox) vial, and all vials were reconstituted with 2.0 mL of 0.9% sterile nonpreserved saline solution to a final dilution of 5 U /0.1 mL. The dose of BTX-A per injection site was 2.5 U to 5 U, and the location, number of injection sites. Using a 30-gauge needle, injections were angled away from the center of lid to reduce the risk of spread into the levator muscle. Injection sites include the upper medial and lateral eyelid margins, lower lateral lid margins, and above the eyebrow.
16294742|NCT00682747|Drug|Hyperbaric oxygen|40 treatments with hyperbaric oxygen once per day, five days per week, 2.4 ATA, 100 % oxygen (10-15 minutes compression with air, 90 min of oxygen breathing - two 10 minutes break for breathing air after each 30 minutes of oxygen, 10 minutes decompression with oxygen
16294743|NCT00682734|Drug|metoclopramide|metoclopramide 20 mg
16294744|NCT00682734|Drug|metoclopramide|metoclopramide 40 mg
16294745|NCT00682734|Drug|metoclopramide|metoclopramide 10 mg
16294746|NCT00682734|Drug|Diphenhydramine 25mg|Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
16294747|NCT00682721|Drug|Placebo|Matching placebo two pills once daily
16294748|NCT00682721|Drug|Valacyclovir|1 gram daily x number of days active in the study
16294749|NCT00682708|Dietary Supplement|PlumpyNut|
16294750|NCT00682708|Dietary Supplement|PlumpyDoz|
16294751|NCT00682682|Other|Virtual Reality video distraction|"Virtual Reality involves wearing a helmet and playing a game called Snow world. This game has sound and is presented in 3D format. This game has immersive qualities that help user feel as if they are in the game."
16294752|NCT00682682|Other|Virtual Reality video game|"Virtual Reality video games involve wearing a helmet with vision and sound. this game is presented in 3D which gives the user the feeling of being in the game. The game used for this study is Snow World"
16294754|NCT00682669|Behavioral|HLC|An 8-week program consisting of lectures and discussion of health-related topics.
16294755|NCT00682656|Drug|Glucantime®|15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day
16294756|NCT00682656|Drug|Zithromax ®|Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days
16294757|NCT00682643|Drug|fluticasone furoate nasal spray|fluticasone furoate nasal spray
16294758|NCT00682643|Drug|vehicle placebo nasal spray|placebo
16294759|NCT00682630|Drug|pyronaridine artesunate|720:240 mg of the reference tablet formulation; wash out period of 43 days; 720:240 mg of the to-be-marketed formulation; wash out period of 43 days
16294760|NCT00682617|Behavioral|Structured exercise program|Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
16294761|NCT00682617|Behavioral|Waitlist, delayed intervention|Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
16294762|NCT00682578|Drug|Dihydroartemisinin + Piperaquine (Artekin)|An adult dose consists of four doses of two tablets, given at 0, 8, 24 and 48 h. The approximate total adult dose is 6/48 mg/kg (DHA/PPQ). For children, a dose of 1.6/12.8 mg/kg is given at the same time intervals; this dosage will be obtained by dissolving the tablets in 5 ml of water.
16294763|NCT00682578|Drug|artesunate-sulphadoxin/pyrimethamine, chloroquine|The standard treatment will be in accordance with that in Afghanistan
16294764|NCT00682565|Drug|CK-1827452 24mg and 6 mg iv infusion|I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr
16294765|NCT00682565|Drug|CK-1827452 12.5mg capsule|12.5mg oral immediate release capsule
16294766|NCT00682565|Drug|CK-1827452 48 mg and 11 mg iv infusion|I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr
16294767|NCT00682565|Drug|CK-1827452 25mg capsule|25mg oral immediate release capsule
16294768|NCT00682565|Drug|Placebo iv infusion|Matching placebo iv infusion
16294769|NCT00682565|Drug|Placebo capsule|Matching placebo oral immediate release capsule
16294770|NCT00682552|Procedure|A cervico-vaginal cervical smear|12 and 18 months after inclusion, a cervico-vaginal cervical smear will be realized and a new examination colposcopique with a new cervical taking for the search(research) and the detection of the HPV 16 and 18.
16294771|NCT00682539|Drug|Bevacizumab (Avastin)|The intravitreal injection of Bevacizumab (Avastin®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.
16294772|NCT00682539|Drug|Triamcinolone|The intravitreal injection of triamcinolone (Volon A®) is performed in the operating room under sterile conditions at baseline. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.
16294773|NCT00682539|Drug|Sham|Patients receiving sham intravitreal injections do not receive an actual injection of study drug. The injecting physician performing the sham injection will be unmasked to the treatment to the treatment assignment regarding active versus sham. The injecting physician will perform the same pre-injection procedures for the patients receiving bevacizumab or triamcinolone, An empty syringe without a needle will be used in the sham injection. The injecting physician will mimic an intraocular injection by making contact with the conjunctiva and applying pressure without the needle. Immediately following the sham injection, the injecting physician will perform the same post-injection procedures as those performed on patients receiving bevacizumab or triamcinolone.
16294774|NCT00682539|Procedure|Lucentis|The intravitreal injection of Ranibizumab (Lucentis®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.05ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.
16294775|NCT00682526|Device|SmartLink Wireless Monitoring System (K033642)|All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation.
16294776|NCT00682500|Drug|Calfactant|Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
16294777|NCT00682500|Drug|Room Air (placebo)|Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
16294778|NCT00682487|Other|Hair sampling for cortisol|Hair sampling for cortisol
16294779|NCT00682487|Other|Hair sampling for cortisol|Hair sampling for cortisol
16294848|NCT00681928|Procedure|psychosocial assessment and care|For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
16294780|NCT00682474|Behavioral|Counseling Intervention|Four 30-minute individual student-centered smoking cessation counseling intervention sessions delivered by school nurses to adolescent smokers in grades 9-12
16294781|NCT00682474|Behavioral|Information Intervention|Attention-control comparison condition consisting of four individual sessions with the school nurse to check smoking status and deliver a series of standardized pamphlets on smoking and cessation to adolescent smokers in grades 9-12
16294782|NCT00682461|Drug|Nicotine|Marketed nicotine replacement therapy formulation
16294783|NCT00682461|Drug|Nicotine|Nicotine prototype
16294784|NCT00682448|Drug|Metformin|Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.
16294785|NCT00682448|Drug|Placebo|Drug: Placebo. Subjects will remain on placebo for 6 months.
16294786|NCT00682435|Drug|Hydromorphone|"1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
16294787|NCT00682409|Other|MR Imaging|MR imaging in the post operative follow-up of cholesteatoma in children
16294788|NCT00682383|Drug|Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta|"Cisplatin 75 mg/m2 day 1 and 22
~Etoposide 80mg/m2 days 1-3, 22-24
~Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days)
~Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34
~Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles
~Pegfilgrastim 6 mg SQ injection day 2 of each cycle"
16294789|NCT00682370|Drug|saline solution|intravenous infusion, single dose
16294790|NCT00682370|Drug|heme arginate|"intravenous infusion, single dose
~0.3 mg/kg heme arginate"
16294791|NCT00682370|Drug|heme arginate|"intravenous infusion, single dose
~1 mg/kg heme arginate"
16294792|NCT00682370|Drug|heme arginate|"intravenous infusion, single dose
~3 mg/kg heme arginate"
16294793|NCT00682357|Drug|Methylprednisolone and Lidocaine|Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
16294794|NCT00682357|Drug|Methylprednisolone and Lidocaine|Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
16294795|NCT00682357|Drug|Placebo and Lidocaine|Placebo and lidocaine 20 mg
16294796|NCT00682344|Drug|Levobupivacaïne|1,75mg/kg
16294797|NCT00682318|Drug|Fish Oil|"Part 1.1: Dose of 9.3 g/day EPA plus 7.5 g/day DHA;
~Part 2a (run-in phase): Dose of 1 time 2 capsules per day of Lovaza (total of 1.7 g/d ω-3 PUFA consisting of 930 mg/day EPA and 750 mg/day DHA) for 29±1 days;
~Part 2a (study arm): Dose of 3 times 4 capsules per day of Lovaza (total of 10.1 g/d ω-3 PUFA consisting of 5580 mg/day EPA and 4500 mg/day DHA) for 29±1 days"
16294798|NCT00682318|Dietary Supplement|Safflower Oil|Part 2a: (Study Arm): Omega-6 polyunsaturated fatty acids 3 times 4 capsules per day (total of 10.2 g/d ω-6 PUFA) for 29±1 days
16294799|NCT00682318|Dietary Supplement|Ethanol|"Part 1 & Part 1.1:
~Dose of 0.9 g/kg body weight 98% alcohol solution
~Part 2a:
~Doses of 0.4 and 0.9 g/kg body weight 98% alcohol solution and a control placebo drinking solution
~Part 2b, Part 3:
~Doses of 0.4, 0.6 and 0.9 g/kg body weight 98% alcohol solution"
16294800|NCT00682318|Dietary Supplement|Omega-3 polyunsaturated fatty acids|"Part 2b:
~Alimentary diet delivering ≈ 500 mg/day EPA/DHA,or Alimentary diet delivering ≈ 900-1000 mg/day EPA/DHA, or Alimentary diet delivering ≈ 1500-1800 mg/day EPA/DHA;
~Part 3:
~Alimentary diet delivering EPA/DHA in a quantity to be determined by Part 2b."
16294801|NCT00682318|Dietary Supplement|Omega-6 polyunsaturated fatty acid|"Part 2b:
~Control omega-6 fatty acid alimentary diet (<130 mg/day EPA/DHA)"
16294802|NCT00682305|Procedure|Hematopoietic stem cell transplantation|"conditioning regimen:
~day -7: 12g/m^2 Treosulfan
~day -6: 12g/m^2 Treosulfan
~day -5: 12g/m^2 Treosulfan
~day -4: 30mg/kg BW Etoposide
~day -3: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide
~day -2: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide
~day -1: 20mg/kg ATG Fresenius (OPTIONAL)
~day 0: SCT"
16294803|NCT00682292|Drug|Thymoglobulin (ATG)|Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
16294804|NCT00682292|Drug|Daclizumab|Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
16294805|NCT00682279|Drug|oral topotecan (SK&F-104864); lapatinib (GW572016)|This is a single-arm, dose escalation, Phase I study in which doses of oral topotecan will be escalated and lapatinib will be given initially as a fixed dose. This study will examine oral topotecan administered on a five-consecutive day schedule in combination with daily lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and Part 2 of the study will consist of dose finding to determine the MTD regimen of the combination (dose escalation phase).
16294806|NCT00682266|Behavioral|intensity controlled interval training (AIT)|4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months
16294807|NCT00682266|Behavioral|Multidisciplinary approach (MTG)|exercise, dietary and psychological advice, twice a month for 12 months
16294808|NCT00682240|Procedure|laser treatment with PASCAL®|panretinal laser treatment - single-session
16294809|NCT00682240|Procedure|laser treatment with PASCAL®|panretinal laser treatment - multi-session
16294810|NCT00682240|Procedure|laser treatment with PASCAL®|grid / focal laser treatment
16294811|NCT00682240|Procedure|laser treatment with conventional laser system|panretinal laser treatment - multi-session according to the conventional protocol, using a conventional laser system
16294812|NCT00682227|Biological|TTK, LY6K, and IMP-3 peptides|Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
16294813|NCT00682214|Drug|Cholecalciferol|Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months
16294814|NCT00682214|Drug|Lactose placebo|Lactose placebo granules in identical sachet given weekly and two lactose tablets for first two months followed one sachet of placebo granules every month and two tablets of lactose containing placebo tablets taken daily for next four months
16294815|NCT00682188|Behavioral|Counseling Intervention|Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)
16294816|NCT00682188|Behavioral|Information Intervention|Six individual sessions with the school nurse over 2 months to check weight and behavioral changes and provide a series of six pamphlets on weight and weight management
16294817|NCT00682175|Other|Observational|Pulmonary Artery pressure (PA), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), and cardiac index (CI). This data will be collected after 24 ± 2 and 48 ± 2 hours of standard heart failure therapy
16294818|NCT00682162|Device|Acupuncture|The treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). The acupuncture treatment was semi-standardised. It consisted of a basic pool of 6 body acupuncture points. Five additional acupuncture body points together with auricular points formed an individual pool. After needle insertion, the needle was manipulated until the subject obtained the de-Qi response (a deep aching or full feeling at the needle, [22]). After obtaining the de-Qi response, there was no further manipulation of the needle. Each session lasted 20 minutes.
16294819|NCT00682162|Device|Sham-laser acupuncture|The sham-laser acupuncture treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). Sham-laser acupuncture was applied at the same points as the acupuncture treatment. A deactivated laser pen (Seirin, 3B Scientific GmbH, Hamburg, Germany) that could only beam normal red light rather than laser was used. The total number of acupuncture points utilized was equal to the acupuncture group. Every point was treated for 30 sec with the total treatment time of 20 minutes.
16294820|NCT00682149|Dietary Supplement|PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)|1 tablet/day for 3 months
16294821|NCT00682136|Procedure|US-Guided Ropivacaine TAP Block|Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
16294822|NCT00682123|Dietary Supplement|19-norandrostendione|"Volunteers recieved 500mL of water containing 5g of creatine monohydrate and either 1.0μg, 2.5μg or 5.0μg of 19-norandrostendione in a single-blind crossover manner.
~The amount of 19-norandrostendione administered was trivial, and far less than the amounts shown to be present in many popular dietary supplements. The recommended dosage according to the distributors is 100 mg 2-3 times daily, so the administered daily dose was not more than 0.05% of the recommended dose. This dose has no measurable physiological or pharmacological effects."
16294823|NCT00682097|Drug|RO4998452|Escalating oral doses
16294824|NCT00682097|Drug|placebo|Oral doses
16294825|NCT00682084|Procedure|Surgery|Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor
16294826|NCT00682058|Other|Follow-up post-bariatric surgery|Follow-up of those subjects who had bariatric surgery (as part of the parent LABS trial) immediately following the collection of baseline measures (body composition) in this study. Follow-up body composition measures will be acquired at 60 months and 84 months post-baseline measures (post-surgery).
16294827|NCT00682032|Dietary Supplement|beta-glucan|AIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery
16294828|NCT00682019|Drug|Levitra (Vardenafil, BAY38-9456)|5mg, 10mg or 20mg taken 8 hours before sexual intercourse
16294829|NCT00682019|Drug|Placebo|matching placebo
16294830|NCT00682006|Drug|4% Chlorhexidine|4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
16294831|NCT00682006|Other|Hand washing Soap|Hand washing soap was provided to Mothers through TBAs.
16294832|NCT00682006|Drug|4% Chlorhexidine|4% Chlorhexidine was provided to be applied by Mothers through TBAs.
16294833|NCT00681993|Other|Standard Dose Dense Doxorubucin and Cyclophosphamide|4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
16294834|NCT00681993|Other|Standard Doxorubucin and Cyclophosphamide|4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
16294835|NCT00681993|Other|Standard Docetaxel, Carboplatin, and Herceptin|6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
16294836|NCT00681993|Other|Standard Docetaxel, Doxorubucin and Cyclophosphamide|3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
16294837|NCT00681993|Other|Standard Docetaxel and Cyclophosphamide|4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
16294838|NCT00681980|Drug|Valproic acid|15 mg/kg/day
16294839|NCT00681980|Drug|costicosteroids|metypredsolone 1 g/day
16294840|NCT00681980|Drug|valproid acid plus corticosteroids|valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
16294841|NCT00681967|Drug|Gefitinib|250 mg; oral
16294842|NCT00681967|Drug|Gefitinib|250mg; oral
16294843|NCT00681941|Drug|Sevelamer carbonate (Renvela®)|Sevelamer Carbonate Tablets Dosed Three Times A Day
16294844|NCT00681928|Drug|anastrozole|As determined by the subject's physician
16294845|NCT00681928|Drug|letrozole|As determined by the subject's physician
16294846|NCT00681928|Other|questionnaire administration|For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
16294847|NCT00681928|Procedure|cognitive assessment|For cancer patients prior to starting medication and 6 months after starting medication. For healthy controls, one time administration.
16294849|NCT00681915|Drug|AZD7325|Oral
16294850|NCT00681902|Drug|Lidocaine|Jet lidocaine compared to jet placebo before needle insertion
16294851|NCT00681902|Drug|Placebo|Jet saline
16294852|NCT00681889|Drug|Ranibizumab|10 Patients will receive treatment (Ranibizumab)
16294853|NCT00681876|Drug|Irinotecan|Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
16294854|NCT00681876|Drug|Avastin|Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
16294855|NCT00681876|Drug|Erbitux|Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
16294856|NCT00681863|Drug|pramipexole 0.125 mg BID|titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
16294857|NCT00681863|Drug|pramipexole 0.0625 mg QD|dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
16294858|NCT00681863|Drug|pramipexole 0.125 mg TID|titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
16294859|NCT00681863|Drug|pramipexole 0.25 mg BID|titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
16294860|NCT00681863|Drug|pramipexole 0.0625 mg BID|0.0625 mg BID given for first 4 wks of treatment
16294861|NCT00681824|Biological|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)|Application of a thin layer of FS VH S/D 500 s-apr to the entire length of the suture loop and the adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
16294862|NCT00681824|Procedure|Standard of care|Standard care: defined as the closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
16294863|NCT00681811|Drug|HGT-1111|Patients currently dosed with 100 U/kg or 200 U/kg will continue this treatment. Patients dosed with 50 U/kg will be equally randomized to treatment on 100 U/kg or 200 U/kg. The dose will be adjusted every 6-week to account for changes in body weight.The infusion length will be dependent on the dose. Infusion of 100 U/kg will be diluted in 50 ml isotonic sodium chloride and infused over 30 minutes. Infusion of 200 U/kg will be administered in the same manner except for an infusion time of 60 minutes.
16294864|NCT00681798|Drug|Vandetanib|100mg/300mg
16294865|NCT00681785|Drug|dalteparine (Fragmin)|transurethrals surgery with and without dalteparine
16294866|NCT00681772|Drug|Levitra (Vardenafil, BAY38-9456)|5mg, 10mg or 20mg taken 1 hours before sexual intercourse
16294867|NCT00681746|Drug|AZD6280|Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.
16294868|NCT00681746|Drug|(11C) flumazenil|Single dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)
16294869|NCT00681733|Drug|Pioglitazone|Pentoxifylline 1200mg/day in 3 divided doses. Pioglitazone 30 mg/day in single dose
16294870|NCT00681733|Drug|Pioglitazone|30 mg OD
16294871|NCT00681733|Drug|Pentoxifylline|1200 mg/d
16294872|NCT00681720|Drug|AZD7325|Single dose of oral solution or capsule. 3 times per subject.
16294873|NCT00681720|Drug|Radioligand (11C) flumazenil|Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)
16294874|NCT00681694|Radiation|brachytherapy|An experimental arm using MRI imaging and excluding the transition zone from the target volume
16294875|NCT00681694|Radiation|brachytherapy|Standard ultrasound-guided brachytherapy with standard target volumes
16294876|NCT00681694|Radiation|brachytherapy|Standard ultrasound-guided brachytherapy with standard target volumes
16294877|NCT00681668|Drug|Quetiapine|150-800 mg, oral, twice a day (bid)
16294878|NCT00681655|Drug|Alcohol|Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).
16294879|NCT00681655|Drug|Placebo|Placebo (saline vehicle) infused for 2.8 hour long session.
16294880|NCT00681629|Drug|Quetiapine XR|400-800 mg, oral, bid
16294881|NCT00681629|Other|Integrated Care Program (ICP)|Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.
16294882|NCT00681616|Device|Compartment Monitoring System (CMS)|The CMS consists of an Introducer, Pressure Measurement & Fluid Collection (PMFC) catheter, a Fluid Collection (FC) catheter and Compartment Pressure Monitor. The PMFC catheter removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The FC catheter only removes fluid and does not have a pressure transducer at the tip. The CMS Monitor senses, displays and records compartment pressure as measured by up to two PMFC catheters. In addition, the CMS Monitor measures subject blood pressure using a provided cuff for calculating the perfusion pressure of the muscle compartment.
16294883|NCT00681616|Device|Compartment Monitoring System with Active Fluid Removal|Compartment Monitoring System with Active Fluid Removal
16294884|NCT00681616|Device|Compartment Monitoring System without fluid removal|Compartment Monitoring System without fluid removal
16294885|NCT00681603|Drug|subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)|subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed.
16294886|NCT00681590|Dietary Supplement|cholecalciferol (vitamin D)|400 IU daily (low dose)
16294887|NCT00681590|Dietary Supplement|cholecalciferol (vitamin D)|2000 IU daily (high dose)
16294888|NCT00681577|Biological|URLC10, KOC1, VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.
16294889|NCT00681564|Procedure|One-Stage Full-Mouth Disinfection|"Scaling and root planing, four quadrants in one session
~Tongue brushing with a 1% chlorhexidine gel (1 minute)
~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
~Subgingival chlorhexidine (1%) irrigation in all pockets
~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
~Basic oral hygiene instructions
~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
16294890|NCT00681564|Procedure|Periodontal care|"Basic oral hygiene instructions
~Supragingival plaque removal"
16294891|NCT00681551|Drug|Magnevist (SH L 451A)|Magnevist at a dose of 0.1 mmol/kg
16294892|NCT00681551|Drug|Magnevist (SH L 451A)|Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.
16294893|NCT00681538|Drug|Sativex®|containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg)
16294894|NCT00681538|Drug|Placebo|containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).
16294895|NCT00681525|Drug|ABT-335|One ABT-335 135 mg capsule QD for 10 days
16294896|NCT00681525|Drug|Atorvastatin|One 80 mg tablet of atorvastatin QD for 10 days
16294897|NCT00681525|Drug|Ezetimibe|One ezetimibe 10 mg tablet QD for 10 days
16294898|NCT00681512|Dietary Supplement|berry powder|"All subjects (lung cancer survivors and volunteers) will consume 20 grams of berry powder (blueberries, black raspberries, or a mixture of both) per day by mouth for the first 3 days, then 40 grams of berry powder by mouth every day for 4 to 5 weeks.
~The berry powder is to be mixed in subject's routine intake of milk, yogurt, juice, or water.
~All subjects will have the option to continue the berry regimen for an extended period. Subjects who choose to do so will not consume any berry powder for one week. After one week, subjects will begin consuming 40 grams of the berry powder every day for an additional 4 to 5 weeks."
16294899|NCT00681486|Drug|Ghrelin|High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
16294900|NCT00681486|Drug|Ghrelin|Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
16294901|NCT00681473|Radiation|Proton Radiation Therapy|Once daily, Monday through Friday, for 6 weeks.
16294902|NCT00681460|Drug|human recombined insulin|multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
16294903|NCT00681460|Drug|metformin|pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
16294904|NCT00681447|Procedure|Lumbar Interlaminar Epidural|"Lumbar interlaminar epidural injections under fluoroscopy
~Epidural tray and needle
~Drugs:
~0.5% Xylocaine and non-particulate Celestone"
16294905|NCT00681447|Procedure|Lumbar Interlaminar Epidural injection|"Lumbar interlaminar epidural injections under fluoroscopy
~Epidural tray and needle
~Drugs:
~0.5% Xylocaine and non-particulate Celestone"
16294906|NCT00681434|Behavioral|bilateral upper extremity training|Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
16294907|NCT00681434|Behavioral|Unilateral upper extremity training|Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.
16294908|NCT00681421|Biological|URLC10, VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16294909|NCT00681408|Drug|Omega 3 Fish Oil supplements|Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
16294910|NCT00681408|Drug|Placebo|Fish oil placebo pills
16294911|NCT00681395|Drug|ABT-143|once daily for 6 days
16294912|NCT00681395|Drug|ABT-335|once daily for six days
16294913|NCT00681395|Drug|Rosuvastatin|Once daily for 6 days
16294914|NCT00681356|Drug|4975, 15 and 5 mg|Direct instillation into the surgical site
16294915|NCT00681356|Drug|Placebo Comparator|Direct instillation into the surgical site
16294916|NCT00681356|Drug|4975 - 5 mg|Direct instillation into the surgical site
16294917|NCT00681343|Drug|Thymoglobulin|Induction
16294918|NCT00681343|Drug|Campath-1H|Induction
16294919|NCT00681343|Drug|Daclizumab|Induction
16294920|NCT00681330|Biological|URC10, TTK, KOC1|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16294921|NCT00681317|Drug|AZD6280|oral
16294922|NCT00681304|Other|ultrasound scan|The only study procedure involved in this project is for subjects to undergo an ultrasound scan during their radiation therapy simulation. The ultrasound is done at this time, so it can be co-registered to the routine breast treatment planning CT scan.
16294923|NCT00681291|Device|Inguinal hernia repair with Ultrapro|surgical mesh (15x15cm) to support Lichtenstein repair
16294924|NCT00681291|Device|Inguinal hernia repair with Strattice|Surgical mesh (10x16) used to support Lichtenstein repair
16294925|NCT00681265|Drug|glycerin|Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.
16294926|NCT00681265|Drug|polyethylene glycol 400/propylene glycol|Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation
16294927|NCT00681252|Biological|URLC10, VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.
16294928|NCT00681239|Dietary Supplement|Modified Atkins diet and KetoCal|10 gram per day Modified Atkins diet and 10 oz per day of KetoCal shake.
16294929|NCT00681226|Drug|Ramipril or matching placebo|10 mg Ramipril or matching placebo once daily for 6 months
16294930|NCT00681213|Drug|Tacrolimus/Sirolimus|
16294931|NCT00681213|Drug|Tacrolimus/MMF|
16294932|NCT00681213|Drug|Neoral/Sirolimus|
16294933|NCT00681200|Behavioral|Enhanced health education|health education and social support
16294934|NCT00681200|Behavioral|Transcendental Meditation program|The TM program plus didactic-based health education classes
16294935|NCT00681187|Drug|lanreotide (Autogel formulation)|90 mg or 120 mg once every 28th day
16294936|NCT00681174|Drug|Morphine|0.15 mg/kg i.v. bolus, 30 minutes before the expected end of anesthesia
16294937|NCT00681174|Drug|oxycodone|20 mg p.o. 1 h before the start of anesthesia
16294938|NCT00681174|Procedure|Paravertebral block|"Three injections of 0.5% ropivacaine, 5 ml each
~Injections at the T5, T6 and T7 levels
~A 22G spinal needle will be used to contact the ipsilateral transverse process; the needle will be walked off the process and the injection will be made 1 cm deeper."
16294939|NCT00681174|Drug|Propofol|"Plasma concentration target-controlled infusion based on bispectral index values
~Acceptable range of concentrations: 2-4 µg/mL
~Target bispectral index values: 40-60
~Infusion starts at 4 µg/ml target, after pre-oxygenation (i.e., start of anesthesia)"
16294940|NCT00681174|Drug|Remifentanil|"50 µg/mL i.v. solution infused at 0.05-0.2 µg/kg/min
~Infusion starts 7 min before propofol infusion (i.e., start of anesthesia)
~Infusion rate adjusted to maintain mean arterial blood pressure within ±20% of baseline values.
~Infusion stopped after end of surgery and after patients are brought back to the supine position (i.e., end of anesthesia)"
16294941|NCT00681174|Drug|Paracetamol|1 g i.v. bolus 30 min before the end of anesthesia; 1 g i.v. bolus q8h thereafter.
16294942|NCT00681174|Drug|Morphine|"Patient-controlled intravenous infusion pump (IV-PCA).
~50 mg morphine in 50 ml saline solution (1 mg/ml)
~Incremental dose: 1 mg
~Lock-out time: 8 min
~Limit: 40 mg in 4 h
~Background infusion: none"
16294943|NCT00681161|Other|continuous positive airway pressure (CPAP)|Standard of care treatment for OSA, requires a mask attached by tubing to a device providing continuous pressure of air at a given cm of water pressure, acting as a splint to open airway at night to relieve obstruction.
16294944|NCT00681148|Drug|Botox injection|Intraprostatic injection of Botox (100 units for < 30 cc prostate; 200 units for > 30 cc prostate) administering 2 transperineal injections into both lateral lobes of the prostate (25-50 units per injection), just 5-10 mm proximal to the bladder neck.
16294945|NCT00681148|Drug|Saline injection|Saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (1-2 cc per injection), just 5-10 mm proximal to the bladder neck.
16294946|NCT00681135|Device|sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)|toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
16294947|NCT00681135|Device|manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)|toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
16294948|NCT00681135|Device|manual toothbrush (elmex® Inter X medium toothbrush)|toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
16294949|NCT00681135|Device|manual toothbrush (elmex® Inter X medium toothbrush)|toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
16294950|NCT00681109|Drug|2.5% IL-1Ra|2.5% custom made topical IL-1Ra three times a day in both eyes for three months
16294951|NCT00681109|Drug|Placebo|custom eye drop to be applied three times a day in both eyes for three months
16294952|NCT00681109|Drug|5% IL-1Ra|5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
16294953|NCT00681083|Device|Heated breathing tube (CPAP with ThermoSmart)|CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
16294954|NCT00681083|Device|Non heated breathing tube (CPAP with conventional humidification)|CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
16294955|NCT00681070|Other|Arm 2: Absorbable sutures|use of absorbable catgut sutures in pediatric facial lacerations
16294956|NCT00681070|Other|Arm 1: non-absorbable sutures|Use of non-absorbing sutures
16294957|NCT00681044|Biological|filgrastim|16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
16294958|NCT00681044|Drug|melphalan|70-100 mg/m2/day will be administered intravenously on Days -3 and -2
16294959|NCT00681044|Procedure|Stem Cell Infusion|infusion of previously collected stem cells on Day 0
16294960|NCT00681031|Biological|ZOSTAVAX®|One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU
16294961|NCT00681018|Other|Liquid human milk fortifier|Liquid human milk fortifier added to human milk
16294962|NCT00681018|Other|Powder human milk fortifier|Powder human milk fortifier added to human milk
16294963|NCT00681005|Drug|rabeprazole|20 mg bid for 14 days
16294964|NCT00681005|Drug|pantoprazole|pantoprazole 40 mg bid
16294965|NCT00680992|Drug|Denosumab|120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
16294966|NCT00680979|Behavioral|Interpersonal Psychotherapy|
16294967|NCT00680979|Behavioral|Health Education|
16294968|NCT00680966|Behavioral|Adolescent Coping With Depression/Functional Family Therapy|ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
16294969|NCT00680953|Drug|Denosumab|Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
16294970|NCT00680953|Drug|Placebo|Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
16294971|NCT00680953|Drug|Alendronate sodium hydrate|Oral tablet once a week for 24 months
16294972|NCT00680940|Drug|Paclitaxel & Cisplatin|Chemotherapeutic agent
16294973|NCT00680940|Biological|Mycobacterium w.|Immunomodulator
16294974|NCT00680927|Other|46 hrs Holter ECG recording|Maximum of 2 46 hrs external Holter ECG recordings are required.
16294975|NCT00680914|Biological|Pneumococcal vaccine GSK1024850A (Synflorix)|3 doses administered intramuscularly.
16294976|NCT00680914|Biological|Prevenar|3 doses administered intramuscularly.
16294977|NCT00680914|Biological|GSK Biologicals' Hiberix™|3 doses administered intramuscularly.
16294978|NCT00680901|Drug|Lapatinib|5 pills at 250mg each once daily
16294979|NCT00680901|Drug|Placebo|5 pills once daily
16294980|NCT00680901|Drug|Capecitabine|1700mg/m2/day in two daily doses
16294981|NCT00680901|Drug|Oxaliplatin|130mg/m2 on day 1
16294982|NCT00680875|Behavioral|Click City|School-based intranet delivery of tobacco use prevention program for 5th and 6th graders using interactive and engaging game-like multi-media technology.
16294983|NCT00680836|Drug|Placebo|orally two times per day for 14 days
16294984|NCT00680836|Drug|Rifaximin|550 mg orally two times per day for 14 days
16294985|NCT00680823|Drug|Ropivacaine|1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
16294986|NCT00680823|Drug|Normal saline|1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
16294987|NCT00680797|Drug|Testosterone|Testosterone gel
16294988|NCT00680797|Drug|Estrogen|Estrogen patch
16294989|NCT00680784|Drug|HKT-500 Ketoprofen Topical Patch|HKT-500 Ketoprofen Topical Patch
16294990|NCT00680784|Other|Placebo Patch|Placebo Patch
16294991|NCT00680758|Drug|cisplatin|"Dose Level: -3 20mg/m2/week 3-6 patients
~Dose Level: -2 20mg/m2/week 3-6 patients
~Dose Level: -1 25mg/m2/week 3-6 patients
~Dose Level: 1 25mg/m2/week 3-6 patients
~Dose Level: 2 25mg/m2/week 3-6 patients
~Dose Level: 3 25mg/m2/week 3-6 patients"
16294992|NCT00680758|Drug|everolimus|"Dose Level: -3 20mg/m2/week 3-6 patients
~Dose Level: -2 20mg/m2/week 3-6 patients
~Dose Level: -1 20mg/m2/week 3-6 patients
~Dose Level: 1 20mg/m2/week 3-6 patients
~Dose Level: 2 25mg/m2/week 3-6 patients
~Dose Level: 3 30mg/m2/week 3-6 patients"
16294993|NCT00680758|Drug|paclitaxel|"Dose Level: -3 65mg/m2/week 3-6 patients
~Dose Level: -2 70mg/m2/week 3-6 patients
~Dose Level: -1 70mg/m2/week 3-6 patients
~Dose Level: 1 80mg/m2/week 3-6 patients
~Dose Level: 2 80mg/m2/week 3-6 patients
~Dose Level: 3 80mg/m2/week 3-6 patients"
16294994|NCT00680745|Drug|dapagliflozin|tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
16294995|NCT00680745|Drug|Glimepiride|tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
16294996|NCT00680745|Drug|metformin hydrochloride|rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
16294997|NCT00680745|Drug|pioglitazone hydrochloride|rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
16294998|NCT00680745|Drug|Rosiglitazone|rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
16294999|NCT00680732|Dietary Supplement|Multiple micronutrients supplements (MMS)|Vitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg
16295000|NCT00680732|Dietary Supplement|Iron and folic acid (IFA)|Iron 60 mg and folic acid 400 mcg
16295001|NCT00680732|Drug|Chloroquine (CQ)|Tablets 100 mg of chloroquine base
16295002|NCT00680732|Drug|Sulphadoxyne-pyrimethamine (SP)|Tablets
16295003|NCT00680719|Behavioral|IBFT /HIV prevention|Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
16295004|NCT00680719|Behavioral|IBFT|Integrated Behavioral and Family Therapy (IBFT).
16295005|NCT00680706|Drug|Thiamine|Thiamine (100 mg) in 50 ml D5W, x 2.
16295006|NCT00680706|Drug|Placebo|D5W (50 ml)
16295007|NCT00680693|Behavioral|Mindfulness training|8 weekly 2-hour classes
16295008|NCT00680693|Behavioral|Psycho-educational support group for women with IBS|8 weekly 2-hour meetings
16295009|NCT00680680|Drug|Dutasteride|Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months
16295010|NCT00680667|Biological|Coriolus versicolor extract|Trametes versicolor (Tv) capsules at the assigned dose level (3 grams/day up to 24 grams/day) twice a day every day and continuing for weeks.
16295011|NCT00680654|Drug|Riociguat (Adempas, BAY63-2521)|The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.
16295012|NCT00680641|Drug|Simvastatin|40mg of Simvastatin once daily
16295013|NCT00680641|Drug|Placebo|40mg of placebo once daily
16295014|NCT00680628|Drug|Tenecteplase + Enoxaparin|"Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
16295015|NCT00680628|Drug|0.9% Saline + Enoxaparin|Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
16295016|NCT00680615|Behavioral|Tailored, enhanced condition|Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.
16295017|NCT00680615|Behavioral|Usual Care|The Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources.
16295018|NCT00680602|Behavioral|Group Cognitive Behavior Therapy|Structured protocol described by Cordioli et al., 2003
16295019|NCT00680602|Drug|SSRI (fluoxetine, sertraline, paroxetine, citalopram)|Fluoxetine (80mg/day or maximum tolerated dosage) Sertraline (200mg/day or maximum tolerated dosage) Paroxetine (60 mg/day or maximum tolerated dosage) Citalopram (60 mg/day or maximum tolerated dosage)
16295020|NCT00680589|Biological|injection of mouse TYRP2 DNA|Cohorts of three patients will receive injections with mouse TYRP2 DNA delivered intramuscularly at four different dose levels (500, 2000, 4000 or 8000 μg) every three weeks for six injections.
16295021|NCT00680576|Behavioral|CBT, Cognitive Behavioral Therapy|Eight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use.
16295022|NCT00680576|Behavioral|FFT, Family Functional Therapy|Eight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use.
16295023|NCT00680563|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|sc every month (starting dose 1.2 micrograms/kg)
16295024|NCT00680537|Procedure|Exercises|Completion of a series of shoulder exercises for 6 weeks post device implant
16295025|NCT00680524|Other|Phone-based outreach|Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD
16295026|NCT00680511|Behavioral|Adolescent Methamphetamine Treament (AMT)|AMT Group Therapy plus Functional Family Therapy (FFT)
16295027|NCT00680511|Behavioral|Functional Family Therapy (FFT)|FFT
16295028|NCT00680498|Drug|Ranibizumab|Ranibizumab 0.5 mg
16295029|NCT00680498|Drug|Ranibizumab plus Photodynamic therapy|Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
16295030|NCT00680485|Drug|GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)|
16295031|NCT00680472|Drug|HKT-500 Ketoprofen Topical Patch|HKT-500 Ketoprofen Topical Patch
16295032|NCT00680472|Other|Placebo Patch|Treatment with Placebo Patch
16295033|NCT00680459|Drug|70% ethanol|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
16295034|NCT00680459|Drug|heparin flush solution|heparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
16295035|NCT00680446|Drug|Immunoglobulin G (Ig NextGen 16%)|Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
16295036|NCT00680433|Drug|Ketamine|Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.
16295037|NCT00680433|Drug|Saline|Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
16295038|NCT00680420|Procedure|fine needle aspiration biopsy|One extra biopsy will be taken from the pancreas only in patients who are already undergoing biopsy of a mass or cyst.
16295039|NCT00680407|Other|Placebo|Placebo (5 pills, three times daily) for 48-50 week treatment period
16295040|NCT00680407|Drug|Silymarin 700 mg|700 mg dose (5 pills, three times daily) for 48-50 week treatment period
16295041|NCT00680407|Drug|Silymarin 420 mg|420 mg dose (5 pills, three times daily) for 48-50 week treatment period
16295042|NCT00680394|Drug|mifepristone|200 mg mifepristone
16295043|NCT00680394|Drug|misoprostol|800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
16295044|NCT00680394|Drug|placebo|800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
16295045|NCT00680381|Behavioral|MTI, Minimal Transitional Intervention|Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
16295046|NCT00680381|Behavioral|GTI, Group Transitional Intervention|Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
16295047|NCT00680381|Behavioral|STI, Systems Transitions Intervention|Following 12 weeks of FFT, an individualized eight-week series of therapist meetings with the adolescent, family, police, teachers, coaches and others who can support the adolescent's reduced drug use.
16295048|NCT00680355|Dietary Supplement|golden rice|An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
16295049|NCT00680355|Dietary Supplement|corn oil 0g|0 g of corn oil in the golden rice meal
16295050|NCT00680355|Dietary Supplement|corn oil 10g|10g corn oil in the golden rice meal
16295051|NCT00680355|Dietary Supplement|coren oil 5 g|golden rice meal with 5 g corn oil
16295052|NCT00680342|Drug|Silymarin|700mg dose (5 pills, three times daily) for 24-week treatment period
16295053|NCT00680342|Drug|Silymarin|420mg dose (5 pills, three times daily) for 24-week treatment period
16295054|NCT00680342|Other|Placebo|Placebo (5 pills, three times daily) for 24-week treatment period
16295055|NCT00680329|Drug|Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)|One drop in study eye(s) once daily in the evening for four months
16295056|NCT00680329|Device|Travalert Dosing Aid|Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence
16295057|NCT00680316|Drug|Dornase alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
16295058|NCT00680316|Drug|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
16295059|NCT00680303|Behavioral|The Lidcombe Program for early stuttering|
16295060|NCT00680303|Behavioral|The Lidcombe Program for early stuttering|
16295061|NCT00680303|Behavioral|The Lidcombe Program for early stuttering|
16295062|NCT00680290|Procedure|Exercise|Exercise x 8 weeks
16295063|NCT00680277|Dietary Supplement|spirulina ß-carotene|an acute dose of spirulina up to 5 g
16295064|NCT00680277|Dietary Supplement|spirulina ß-carotene|vitamin A value of spirulina ß-carotene
16295065|NCT00680238|Drug|Human derived FSH|Customized for each patient
16295066|NCT00680225|Drug|Ranibizumab injection and TTT - ICG based|Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
16295067|NCT00680212|Dietary Supplement|dietary carotenoids|spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
16295068|NCT00680212|Dietary Supplement|spinach, rice, and synthetic beta-carotene|spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
16295069|NCT00680186|Drug|Warfarin|PRN (to maintain a target INR of 2.0-3.0)
16295070|NCT00680186|Drug|Dabigatran etexilate|150mg bid
16295071|NCT00680173|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16295072|NCT00680160|Drug|AN2690|AN2690 7.5% Solution, once daily for 28 days
16295073|NCT00680147|Behavioral|brief informational intervention to promote HPV vaccine acceptance|Teen and parent participants will receive a brief informational intervention that provides basic facts about the HPV vaccine, including the health benefits and three-dose requirements, along with information regarding where to go to receive the vaccination. A coupon for a free HPV vaccination will provided to the parent for use by their teenage daughter.
16295074|NCT00680134|Drug|AN2690|AN2690 1% Solution, once daily for 180 days
16295075|NCT00680134|Drug|AN2690|AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days
16295076|NCT00680121|Drug|Benfotiamine|Benfotiamine 600 mg
16295077|NCT00680121|Drug|Placebo|Placebo
16295078|NCT00680108|Drug|diquafosol tetrasodium (INS365) ophthalmic solution|
16295079|NCT00680095|Drug|AN2690|AN2690 Solution, 2.5%, Daily for up to 21 days
16295080|NCT00680095|Drug|AN2690|AN2690 Solution, 7.5%, Daily for up to 21 days
16295081|NCT00680095|Drug|AN2690|AN2690 Solution, 5.0%, Daily for up to 21 days
16295082|NCT00680095|Other|AN2690 Solution, Vehicle|AN2690 Solution, Vehicle, Daily for up to 21 days
16295083|NCT00680095|Other|Sodium Lauryl Sulfate, 0.5%|Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
16295084|NCT00680069|Biological|Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005|Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart.
16295085|NCT00680056|Drug|Formoterol plus Placebo (Tiotropium)|Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.
16295086|NCT00680056|Drug|Formoterol plus Tiotropium|Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.
16295087|NCT00680043|Drug|peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
16295088|NCT00680043|Drug|peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16295089|NCT00680043|Drug|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16295090|NCT00680017|Drug|ABT-335 plus rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
16295091|NCT00680017|Drug|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
16295092|NCT00679991|Drug|PRT-201|Applied topically to AVF during surgery
16295093|NCT00679991|Drug|PRT-201|Dose escalation study. Drug/placebo administered at the time of fistula creation
16295094|NCT00679965|Drug|AN2690, 2.5%|Once daily application for 90 days and 3 x weekly for 90 days
16295095|NCT00679965|Drug|AN2690, 5%|Once daily application for 90 days and 3 x weekly for 90 days
16295096|NCT00679965|Drug|AN2690, 7.5%|Once daily application for 90 days and 3 x weekly for 90 days
16295097|NCT00679965|Drug|AN2690 Solution Vehicle|Once daily application for 90 days and 3x weekly for 90 days
16295098|NCT00679952|Procedure|closed suction drainage of pancreatic duct|A Fr 5-8 silastic polyethylene pediatric feeding tube with multiple side-holes is inserted 2 cm into the pancreatic duct. The catheter exited via a small enterotomy in the jejunal loop of the distal portion of the hepaticojejunostomy. Totally externalized pancreatic stents were connected to the aspiration bag of a Jackson-Pratt drain to generate negative pressure or to a bile bag for natural drainage.
16295099|NCT00679952|Procedure|natural drainage of pancreatic duct|Natural drainage group
16295100|NCT00679939|Drug|Rosiglitazone|up to 8mg/day
16295101|NCT00679939|Drug|Metformin|up to 2000mg/day
16295102|NCT00679926|Drug|Once daily|Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
16295103|NCT00679913|Procedure|Standard pancreatoduodenectomy|Standard pancreatoduodenectomy
16295104|NCT00679913|Procedure|Extended pancreatoduodenectomy|Extended pancreatoduodenectomy
16295105|NCT00679900|Drug|eplivanserin (SR46349)|5 mg/day
16295106|NCT00679900|Drug|lormetazepam|1 mg/day
16295107|NCT00679887|Procedure|ischemic compression|Active Comparator, ischemic compression, 3 times a week,5 weeks
16295108|NCT00679874|Other|Cardio-vascular MRI|Contrast enhanced CMR studies at baseline, in the middle of chemotherapy and as follow-up
16295109|NCT00679861|Behavioral|Counselling Intervention|A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation
16295110|NCT00679861|Behavioral|Expert-system intervention|Counselling letter of three to four pages will be generated by an expert-system base on the assessment of the patient. A second and third letter will be generated at follow-up consultations.
16295111|NCT00679848|Device|RS2 (RESTORe Suturing System)|Suturing in stomach
16295112|NCT00679835|Drug|daptomycin|i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
16295113|NCT00679796|Procedure|Varicella (chickenpox) lesion sampling|
16295114|NCT00679783|Drug|AZD2281|PARP inhibitor
16295115|NCT00679770|Drug|AN2690, 2.5%|Once daily application for 90 days and 3 x weekly for 90 days
16295116|NCT00679770|Drug|AN2690, 5%|Once daily application for 90 days and 3 x weekly for 90 days
16295117|NCT00679770|Drug|AN2690, 7.5%|Once daily application for 90 days and 3 x weekly for 90 days
16295118|NCT00679770|Drug|Vehicle|Once daily application for 90 days and 3x weekly for 90 days
16295119|NCT00679744|Drug|Pyrimethamine|Pyrimethamine will be given PO once daily for 8 consecutive weeks.
16295120|NCT00679731|Drug|ABT-874|200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection
16295121|NCT00679731|Drug|Methotrexate|5.0 to 25 mg weekly
16295122|NCT00679718|Drug|diquafosol tetrasodium (INS365) ophthalmic solution|
16295123|NCT00679705|Drug|Ritodrine|Ritodrine (Pre-Par), maximum 400 µg/minute, IV
16295124|NCT00679705|Drug|Atosiban|Atosiban (Tractocile), maximum 300 µg/minute, IV
16295125|NCT00679705|Drug|Placebo|Glucose 5%, IV
16295126|NCT00679679|Drug|Metformin|Metformin 750 mg BID for 4 months
16295127|NCT00679679|Drug|Placebo|Diet counseling and exercise
16295128|NCT00679666|Drug|Riboflavin|01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
16295129|NCT00679666|Drug|Placebo|Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
16295130|NCT00679653|Drug|sibutramine|8-wks, sibutramine, 10 mg, capsules, once daily
16295131|NCT00679653|Drug|sibutramine|8-wks, sibutramine, 15 mg, capsules, once daily
16295132|NCT00679653|Drug|verapamil/trandolapril|2 wk Run-in phase, antihypertensive therapy only
16295133|NCT00679653|Drug|metoprolol/HCT|2 wk Run-in phase, antihypertensive therapy only
16295134|NCT00679653|Drug|felodipine/ramipril|2 wk Run-in phase, antihypertensive therapy only
16295135|NCT00679640|Drug|Candesartan|Oral tablets
16295136|NCT00679627|Drug|Galantamine|8mg/ day oral capsule increased to 16mg/day then to 24 mg per day
16295137|NCT00679627|Drug|Placebo|Matching placebo
16295138|NCT00679614|Drug|tramacet, naloxone|Group A: oral tramacet 2 tablets preoperatively, then 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. A naloxone infusion will started preop at 0.25ug/kg/hr and will continue during patient's stay in hospital (an equivalent of 400ug over 24 hours in a 70 kg man). Infusion discontinued 1 hour before patient discharge. All the patients in groups A and B will be provided Morphine PCA for the duration of their hospital stay. Use of morphine PCA will be noted.Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice.
16295139|NCT00679614|Drug|tramacet|Group B: oral tramacet 2 tablets preop,then 2 tablets every 6 hours for five days(or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). Group also receives saline infusion at 4-6mls/hour during hospital stay.All patients in groups A and B will have Morphine PCA during hospital stay. Use of morphine PCA will be noted. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraopby the surgeon as per our standard practice.
16295140|NCT00679614|Drug|Acetaminophen|Group C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice. The Visual Analogue Scale, the Ramsay Sedation Score and the Mini Mental State Exam will be used to assess the patients for pain, sedation and confusion every 6 hours while in hospital.
16295141|NCT00679601|Drug|AN2690|AN2690 7.5% Solution, once daily for 28 days
16295142|NCT00679588|Drug|Semuloparin Sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16295143|NCT00679588|Drug|Enoxaparin sodium|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
~Subcutaneous injection"
16295144|NCT00679588|Drug|Placebo|"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection"
16295145|NCT00679562|Drug|Lactic Acid|Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance
16295146|NCT00679562|Other|Distilled water|Application of patches containing distilled water for 24 hours
16295147|NCT00679549|Device|CPAP Therapy|CPAP therapy is provided as an inpatient.
16295148|NCT00679536|Drug|Busulfan|Patient will receive a Test Dose of Busulfan on either Day -10 or Day -9. Patient will receive their Regimen Dose of Busulfan on Day -5 to Day -2. The regimen dose of Busulfan will be based off of the findings from their Test Dose.
16295149|NCT00679536|Drug|Fludarabine|Patient will receive Fludarabine from Day -6 to Day -2. The dose of Fludarabine will be 30 mg/m^2/day.
16295150|NCT00679536|Drug|Thymoglobulin|The patient will also receive Thymoglobulin (rabbitATG) on Day -4 to Day -2. Each dose of rabbitATG will be 1.5 mg/kg/day.
16295151|NCT00679536|Radiation|Total Body Irradiation|On Day -1 the patient will receive a total of 400 cGy of Total Body Irradiation.
16295152|NCT00679523|Drug|AN2690 Solution, 5.0%|Once daily application for 180 days
16295153|NCT00679523|Drug|AN2690 Solution, 7.5%|Once daily application for 180 days
16295154|NCT00679510|Drug|rosuvastatin|tablet 10 mgs once daily
16295155|NCT00679510|Drug|placebo|placebo
16295156|NCT00679497|Biological|MVA-B|"Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)
~-~ 1 x 10e8 pfu/ml
~3 immunisations at week 0, 4 and 16"
16295157|NCT00679497|Biological|Placebo|-3 immunisations at week 0, 4 and 16
16295158|NCT00679484|Drug|olmesartan medoxomil + candesartan cilexetil placebo|Dosage form: tablet; frequency: daily; duration: 24 weeks
16295159|NCT00679484|Drug|olmesartan medoxomil placebo + candesartan cilexetil|Dosage form: tablets; frequency: daily; duration: 24 weeks
16295160|NCT00679458|Drug|buprenorphine and low-dose naloxone|each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug, buprenorphine only, will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.
16295161|NCT00679458|Drug|buprenorphine alone|each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.
16295162|NCT00679445|Device|NeoVista Ophthalmic System|A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.
16295163|NCT00679432|Procedure|Blood sampling, endoscopy|Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
16295164|NCT00679432|Drug|budesonide-MMX® 6 mg|6 mg/day, 6 mg tablets
16295165|NCT00679432|Drug|budesonide-MMX® 9 mg|9 mg/day, 9 mg tablets
16295166|NCT00679432|Drug|Placebo|Placebo
16295167|NCT00679432|Drug|Asacol® 400 mg|2400 mg/day, 400 mg tablets
16295213|NCT00679172|Biological|Dose of 1.1 x 10^10 CFU (Cohort 3)|S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
16295214|NCT00679172|Biological|Dose of of 1.7 x 10^10 CFU (Cohort 4)|S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
16295168|NCT00679406|Behavioral|Brief Behavioral Treatment for Insomnia|Effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.
16295169|NCT00679393|Procedure|Open reduction internal fixation|Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
16295170|NCT00679393|Procedure|Fusion|Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)
16295171|NCT00679380|Procedure|Blood sampling, endoscopy|Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
16295172|NCT00679380|Drug|Budesonide MMX® 6 mg|6 mg/day, 6 mg tablets
16295173|NCT00679380|Drug|Budesonide MMX® 9 mg|9 mg/day, 9 mg tablets
16295174|NCT00679380|Drug|Entocort EC® 3 mg|9 mg/day, 3 mg tablets
16295175|NCT00679380|Drug|Placebo|Placebo
16295176|NCT00679367|Drug|dexamethasone|40 mg once weekly
16295177|NCT00679367|Drug|lenalidomide|10 mg/day D1-21
16295178|NCT00679367|Drug|melphalan|5 mg/m2 D1-4
16295179|NCT00679354|Drug|cilengitide|Given IV
16295180|NCT00679354|Other|laboratory biomarker analysis|Correlative studies
16295181|NCT00679354|Other|pharmacological study|Correlative studies
16295182|NCT00679341|Drug|Trastuzumab emtansine [Kadcyla]|The total dose depended on the patient's weight on Day 1 of each cycle. Trastuzumab emtansine was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease (or until second disease progression for patients who crossed over), unacceptable toxicity, or study closure, whichever occurred first.
16295183|NCT00679341|Drug|Trastuzumab|The dose of trastuzumab was recalculated if body weight changed by more than ±10% from baseline. Trastuzumab was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease, or unmanageable toxicity. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and/or intolerance.
16295184|NCT00679341|Drug|Docetaxel|Docetaxel was given at a dose of 75 or 100 mg/m^2 based on the investigator's decision. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and/or intolerance.
16295185|NCT00679328|Device|Surgical implantation of OP-1 device or autograft bone graft material|Surgical implantation of OP-1 device or autograft bone graft material
16295186|NCT00679315|Drug|alfuzosin hydrochloride XL 10mg|One tablet to be taken daily after a meal before bedtime for 8 weeks.
16295187|NCT00679315|Drug|Placebo|One tablet to be taken daily after a meal before bedtime for 8 weeks.
16295188|NCT00679302|Drug|Trimethoprim-sulfamethoxazole|Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.
16295189|NCT00679302|Drug|Placebo group|Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
16295190|NCT00679289|Drug|HDI|20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week until disease progression
16295191|NCT00679289|Drug|KW2871|5 mg/m^2 IV every 2 weeks until disease progression
16295192|NCT00679289|Drug|KW2871|10 mg/m^2 IV every 2 weeks until disease progression
16295193|NCT00679289|Drug|KW2871|20 mg/m^2 IV every 2 weeks until disease progression
16295194|NCT00679276|Procedure|Prolift|surgical repair of vaginal prolapse
16295195|NCT00679263|Drug|MN-221|Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg)
16295196|NCT00679263|Drug|MN-221|Subsequent dose: 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg).
16295197|NCT00679263|Drug|Placebo|Placebo intravenous infusion with dosing volume equivalent to active treatment.
16295198|NCT00679250|Drug|levocetirizine|5 mg once nightly before visit
16295199|NCT00679250|Drug|placebo to levocetirizine|1 tablet once nightly before visit
16295200|NCT00679237|Behavioral|smoking cessation|NRT and varenicline
16295201|NCT00679237|Drug|betablocker, diuretics, ACEI, ARB,|blood pressure control according to ESC guidelines
16295202|NCT00679237|Drug|statins, ezetimibe|Cholesterol reduction according to ESC guidelines
16295203|NCT00679237|Behavioral|training|daily walking
16295204|NCT00679237|Biological|influenza vaccine|vaccine (FLuarix, Influvac etc)
16295205|NCT00679237|Drug|metformin, glimepiride, insulin|s.glucose control according to ESC guidelines
16295206|NCT00679237|Behavioral|weight reduction|diet tips
16295207|NCT00679224|Drug|ambrisentan|ambrisentan
16295208|NCT00679211|Drug|Trastuzumab emtansine [Kadcyla]|Intravenous repeating dose
16295209|NCT00679198|Behavioral|nurse-patient communication|"We will train home health nurses to act as patient advocates by communicating the risks and benefits of osteoporosis treatment to patients and their healthcare providers.
~Thus, we will provide a comprehensive, integrated approach to the management of osteoporosis among patients with a history of insufficiency fractures that is highly generalizable to a national setting."
16295210|NCT00679185|Behavioral|expressive writing|four non-emotional writing assignments
16295211|NCT00679172|Biological|Dose of 5.0 x 10^9 CFU (Cohort 1)|S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
16295212|NCT00679172|Biological|Dose of 7.5 x 10^9 CFU (Cohort 2)|S. typhi (Ty2 aroC-ssaV-) ZH9 live attenuated typhoid vaccine, single dose, oral administration
16295215|NCT00679172|Other|Placebo (Cohorts 1-4 pooled)|Excipients only, single dose, oral administration
16295216|NCT00679159|Biological|MVA85A|Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis
16295217|NCT00679159|Biological|Prevenar|Streptococcus pneumoniae vaccine
16295218|NCT00679146|Drug|Thiocolchicoside+Ketoprofen|1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
16295219|NCT00679146|Drug|Thiocolchicoside|2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
16295220|NCT00679133|Drug|MGCD265|Oral daily administration; 7 days on / 7 days off
16295221|NCT00679120|Device|Oxford Uni Knee|Oxford Uni Knee inserted at the time of surgery
16295222|NCT00679120|Device|Oxford Uni Knee|Oxford Uni Knee inserted at the time of surgery
16295223|NCT00679120|Device|Oxford Uni Knee|Oxford Uni Knee inserted at the time of surgery (porous coated and HA coated)
16295224|NCT00679107|Device|Use of OP-1 Putty in Uninstrumented posterolateral fusion|Use of OP-1 Putty in Uninstrumented posterolateral fusion
16295225|NCT00679094|Drug|Bowman-Birk inhibitor concentrate|Given orally
16295226|NCT00679094|Other|placebo|Given orally
16295227|NCT00679094|Other|pharmacological study|Correlative studies
16295228|NCT00679094|Other|laboratory biomarker analysis|Correlative studies
16295229|NCT00679081|Device|CelTx|Single application; split-mouth design
16295230|NCT00679081|Other|Autologous sub-epithelial connective tissue graft|Single application; split-mouth design
16295231|NCT00679068|Drug|Bosentan|62.5 mg b.i.d. for 4 weeks, then 125 mg b.i.d.for the remaining 8 weeks (if tolerated)
16295232|NCT00679055|Drug|MK-0736|MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
16295233|NCT00679055|Drug|Comparator: placebo (unspecified)|Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
16295234|NCT00679042|Biological|Islets of Langerhans transplantation|"Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"
16295235|NCT00679029|Drug|doxorubicin hydrochloride|Given IV
16295236|NCT00679029|Drug|cyclophosphamide|Given IV
16295237|NCT00679029|Biological|bevacizumab|Given IV
16295238|NCT00679029|Drug|paclitaxel|Given IV
16295239|NCT00679029|Drug|gemcitabine hydrochloride|Given IV
16295240|NCT00679029|Other|laboratory biomarker analysis|Correlative studies
16295241|NCT00679029|Biological|pegfilgrastim|Given subcutaneously
16295242|NCT00679003|Behavioral|SLCBT|Social learning and cognitive behavioral therapy
16295243|NCT00679003|Behavioral|ES|Education and support (information about nutrition and gastrointestinal system)
16295244|NCT00678990|Procedure|Transplantation of islets with heparin coating|Transplantation of islets with heparin coating
16295245|NCT00678977|Drug|Pazopanib (GW786034)|initial dose 400mg daily in 21-day cycles; increase in dose up to 800mg daily following evaluation of safety and tolerability
16295246|NCT00678977|Drug|Gemcitabine|Gemcitabine on Days 1 and 8 of each cycle; initial dose 600 mg/m2 increase to 1,000mg/m2 after evaluation of safety and tolerability; increase to 1250mg/m2 after evaluation of safety and tolerability
16295247|NCT00678977|Drug|Cisplatin|Cisplatin on Day 1 of each 21-day cycle initial dose 60mg/m2; increase to 80mg/m2 after evaluation of safety and tolerability
16295248|NCT00678964|Drug|Erlotinib|Erlotinib 150 mg, p.o., once daily
16295249|NCT00678964|Drug|Vinorelbine and Carboplatin|Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle
16295250|NCT00678938|Behavioral|Smoking abstinence oriented expert system intervention|Participants received up to three counselling letters targeting smoking cessation
16295251|NCT00678938|Behavioral|Smoking reduction oriented expert system intervention|Participants received up to three counselling letters targeting smoking reduction
16295252|NCT00678925|Dietary Supplement|Phosphatidylcholine|850 mg per day from 18 weeks pregnancy through 90 days postpartum
16295253|NCT00678925|Dietary Supplement|Corn oil placebo|Placebo capsules containing corn oil given from 18 weeks pregnancy through 90 days postpartum
16295254|NCT00678912|Device|Smartcare/PS|computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
16295255|NCT00678899|Device|Nucleus Hybrid L24|Implantation with Nucleus Hybrid L24 cochlear implant
16295256|NCT00678886|Biological|otelixizumab infusion plus physician determined standard of care|infusion
16295257|NCT00678886|Biological|placebo infusion plus physician determined standard of care|infusion
16295258|NCT00678873|Procedure|Single Incision Laparoscopic Cholecystectomy|A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
16295259|NCT00678847|Device|KFH NOVO (inactive) + SCT|inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
16295260|NCT00678847|Device|KFH Novo (BEST) + SCT|2 x 1 hour/day bio-electrical stimulation (BEST) for total period for total period of 8 weeks in combination with standardized conventional therapy (SCT)
16295261|NCT00678834|Dietary Supplement|To surgery patients, Tocopherol capsules.|200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
16295262|NCT00678834|Dietary Supplement|Tocotrienol to healthy subjects.|200 mg to take orally two times a day (400 mg a day).
16295263|NCT00678834|Dietary Supplement|To surgery patients, Tocotrienol capsules.|200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
16295265|NCT00678795|Drug|Sativex®|"Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L.
~Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours"
16295266|NCT00678795|Drug|Placebo|containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.
16295267|NCT00678782|Drug|etanercept|etanercept 12.5mg, intraarticular injection administered once every two weeks for an eight week period
16295268|NCT00678782|Drug|placebo|Placebo (NaCl) 0.5 ml intraarticular injection
16295269|NCT00678769|Drug|Cixutumumab|Given IV
16295270|NCT00678769|Other|Laboratory Biomarker Analysis|Correlative studies
16295271|NCT00678769|Other|Pharmacological Study|Correlative studies
16295272|NCT00678769|Drug|Temsirolimus|Given IV
16295273|NCT00678756|Drug|Ketokonazol 2% cream|twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
16295274|NCT00678756|Radiation|UVB-radiation 311nm|3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm
16295275|NCT00678743|Drug|Omacor + simvastatin|Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
16295276|NCT00678730|Drug|delta 9 tetrahydrocannabinol|0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes
16295277|NCT00678717|Procedure|Autonomic Evaluation|Orthostatic vital signs will be determined by measuring heart rate (HR) and brachial blood pressure (BP) during a tilt table test. The degree of vagal mediated sinus arrhythmia will be assessed during controlled breathing (5 seconds inhalation and 5 seconds exhalation during 90 seconds), and the sinus arrhythmia parameters will be calculated as the difference and ratio of the longest to the shortest RR interval. The sympathetic response during breath hold will be measured. Responses of BP, HR, MSNA will be acquired during Valsalva maneuver. The valsalva ratio of heart rate will be calculated from the maximum of heart rate during or shortly after straining and the minimal depressed heart rate in the overshoot phase IV. Blood pressure and MSNA increase during isometric handgrip maintained at 30% of maximal voluntary contraction for five minutes will be determined. The blood pressure and MSNA response will be measured during cold pressor test with the hand in ice water for 1 minute.
16295278|NCT00678704|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 10 mg tablet prior to intercourse on demand
16295279|NCT00678704|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 20 mg tablet prior to intercourse on demand
16295280|NCT00678704|Drug|Placebo|Placebo tablet prior to intercourse on demand
16295281|NCT00678691|Drug|armodafinil|50-250mg/d
16295282|NCT00678691|Drug|placebo|matching placebo
16295283|NCT00678678|Device|Incentive Spirometry - RESPIRON|Device that stimulates the deep breathing, flow-oriented
16295284|NCT00678678|Device|Kit Epap®:|Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface
16295285|NCT00678652|Biological|10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine|10 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
16295286|NCT00678652|Biological|25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine|25 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
16295287|NCT00678652|Biological|50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine|50 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
16295288|NCT00678652|Biological|75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine|75 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
16295289|NCT00678639|Other|Observation unit care, coupled with cardiac MRI|After Emergency Department (ED) evaluation, patients are randomized to Observation unit care or standard inpatient care. Patients in the observation unit will also undergo a stress cardiac MRI. Patients in the usual care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
16295290|NCT00678626|Drug|CP-751,871|Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
16295291|NCT00678626|Drug|Docetaxel|Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
16295292|NCT00678613|Drug|Probiotics and Placebo|The Probiotics used in this study will be VSL#3. The control will be given similar looking capsules containing galactose powder. It will be used in the form of capsules. A total dose of 450 billions CFU will be used. Norfloxacin, 400 mg /day, will also be used as similar looking capsules. The drugs and placebo will be given for one year or till the end points of the study.
16295293|NCT00678613|Drug|Probiotics and Norfloxacin|The Probiotics used in this study will be VSL#3. The control will be given similar looking capsules containing galactose powder.It will be used in the form of capsules. A total dose of 450 billions CFU will be used. Norfloxacin, 400 mg /day, will also be used as similar looking capsules. The drugs will be given for one year or till the end points of the study.
16295294|NCT00678600|Other|Standard (static) Computer Alerts|Static Computer Alerts on Patient's EMR webpage.
16295295|NCT00678600|Other|Enhanced Computer Alerts|Population level and asynchronous alerts with enhanced functionality
16295296|NCT00678587|Drug|Eltrombopag|75 mg, once daily, oral
16295297|NCT00678587|Drug|Placebo|placebo, once daily, oral
16295298|NCT00678574|Drug|fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months.
16295299|NCT00678561|Drug|CP-690,550|Topical treatment once daily for 28 days
16295300|NCT00678561|Drug|CP-690,550|Topical treatment once daily for 28 days
16295301|NCT00678561|Drug|CP-690,550|Topical treatment once daily for 28 days
16295302|NCT00678561|Drug|CP-690,550|Topical treatment twice daily for 28 days
16295303|NCT00678561|Drug|CP-690,550|Topical treatment twice daily for 28 days
16295304|NCT00678561|Drug|CP-690,550|Topical treatment twice daily for 28 days
16295305|NCT00678561|Drug|Placebo Vehicle|Topical treatment once daily for 28 days
16295306|NCT00678561|Drug|Placebo Vehicle|Topical treatment twice daily for 28 days
16295307|NCT00678548|Behavioral|Pleasant guided imagery|CD with pleasant guided imagery
16295308|NCT00678548|Behavioral|Pain diary|Filling out a pain diary
16295353|NCT00678301|Biological|GSK Biologicals' Zilbrix™ Hib|3 IM doses.
16295309|NCT00678535|Drug|Cetuximab|Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
16295310|NCT00678535|Drug|Capecitabine|Capecitabine 1000 mg/m^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
16295311|NCT00678535|Drug|Cisplatin|Cisplatin 80 mg/m^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.
16295312|NCT00678522|Drug|Atorvastatin|80 mg atorvastatin daily on two following days
16295313|NCT00678509|Biological|TTK peptide mixed with Montanide ISA 51|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16295314|NCT00678496|Other|CBT Software|"Beating the Blues is a CBT-based software package for patients with anxiety and/or depression. The CBT strategies used include: identifying thinking errors, challenging automatic negative thoughts, modifying attributional style and identifying core beliefs. The behavioural techniques used include graded exposure, sleep management, problem solving, task breakdown and activity scheduling. The programme consists of a 15 minute Introduction to Therapy video plus eight computer-interactive sessions of approximately 50 minutes each in duration. Each session consists of a mix of cognitive and behavioural strategies, which are customised to the patient's individual problems. The eight computer sessions are designed to be taken weekly, or thereabouts, and each session builds on the previous one."
16295315|NCT00678496|Other|Treatment as usual|Participants in the usual care arm are asked to refrain from accessing psychological services during their participation in the study, but may be prescribed anti-depressants or referred to a counsellor by their general practitioner.
16295316|NCT00678483|Drug|rimonabant (SR141716)|once daily
16295317|NCT00678470|Drug|Intralesional Alefacept|Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
16295318|NCT00678457|Drug|Ondansetron|ondansetron (4 μg/kg b.i.d.)
16295319|NCT00678457|Drug|Olanzapine|olanzapine (9, 18, and 36 μg/kg)
16295320|NCT00678457|Drug|Placebo|placebo
16295321|NCT00678444|Other|Educational video|Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
16295322|NCT00678431|Dietary Supplement|Resveratrol with Glucose, and Malate|Dietary supplement delivered in grape juice
16295323|NCT00678431|Dietary Supplement|Placebo|Liquid placebo
16295324|NCT00678418|Drug|VIVITROL® 380 mg|Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.
16295325|NCT00678418|Drug|Placebo|Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.
16295326|NCT00678405|Behavioral|Breathlessness Intervention Service|Breathlessness Intervention Service (BIS) consists of a clinical specialist physiotherapist & palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease (cancer & non-cancer) using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. Thus BIS seeks to enhance the self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs & allied health professionals (with medical consent).
16295327|NCT00678405|Behavioral|Best supportive care (Standard Care)|Standard care: specialist outpatient appointments in secondary care (e.g. respiratory, cardiology, neurology or oncology) which may include specialist nurse input, and primary care services.
16295328|NCT00678392|Drug|Axitinib (AG-013736)|axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
16295329|NCT00678392|Drug|Sorafenib|sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
16295330|NCT00678379|Drug|lidocaine (1%) + bupivacaine (0.5%)|"Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
~B - lidocaine (1%) + bupivacaine (0.5%)"
16295331|NCT00678379|Drug|Normal saline|"Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
~A - normal saline"
16295332|NCT00678379|Drug|Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)|"Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
16295333|NCT00678366|Procedure|addition of 4% oxygen|addition of 4% oxygen to the carbon dioxide pneumoperitoneum
16295334|NCT00678366|Procedure|carbon dioxde|classic pneumoperitoneum with 100 % carbon dioxide
16295335|NCT00678340|Device|WACA and PVI|Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
16295336|NCT00678340|Device|PVAC|Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
16295337|NCT00678327|Biological|bleomycin sulfate|Given IV
16295338|NCT00678327|Biological|filgrastim|Given subcutaneously
16295339|NCT00678327|Biological|pegfilgrastim|Given subcutaneously
16295340|NCT00678327|Drug|cyclophosphamide|Given IV
16295341|NCT00678327|Drug|dacarbazine|Given IV
16295342|NCT00678327|Drug|doxorubicin hydrochloride|Given IV
16295343|NCT00678327|Drug|etoposide|Given IV
16295344|NCT00678327|Drug|prednisolone|Given orally
16295345|NCT00678327|Drug|procarbazine hydrochloride|Given orally
16295346|NCT00678327|Drug|vinblastine sulfate|Given IV
16295347|NCT00678327|Drug|vincristine sulfate|Given IV
16295348|NCT00678314|Drug|Ropivacaine 0.2%|10 ml
16295349|NCT00678314|Drug|Ropivacaine 0.75%|3 ml
16295350|NCT00678314|Drug|Normal saline|10 ml
16295351|NCT00678301|Biological|GSK Biologicals' Synflorix™|3 IM doses.
16295352|NCT00678301|Biological|GSK Biologicals' Polio Sabin™|3 oral doses
16295354|NCT00678288|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
16295355|NCT00678288|Drug|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
16295356|NCT00678275|Drug|ATG FRESENIUS (Anti-Lymphocyte-Globulin)|conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A
16295357|NCT00678275|Drug|ATG FRESENIUS (Anti-Lymphocyte-Globulin)|conditioning regimen WITHOUT ATG when randomised Arm B
16295358|NCT00678249|Device|FLAIR Endovascular Stent Graft|Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft
16295359|NCT00678249|Procedure|PTA|Percutaneous Transluminal Angioplasty
16295360|NCT00678249|Device|FLAIR Endovascular Stent Graft|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
16295361|NCT00678236|Other|Refobacin Bone Cement R|Insertion of a knee prosthesis fixed by Refobacin Bone Cement R
16295362|NCT00678236|Other|Refobacin Plus Bone Cement|Insertion of a knee prosthesis fixed by Refobacin Plus Bone Cement
16295363|NCT00678210|Drug|CP-690,550|tablets, 2 mg BID for 12 weeks
16295364|NCT00678210|Drug|CP-690,550|tablets, 5 mg BID for 12 weeks
16295365|NCT00678210|Drug|CP-690,550|tablets, 15 mg BID for 12 weeks
16295366|NCT00678210|Drug|Placebo|tablets, BID for 12 weeks
16295367|NCT00678197|Other|Access Intervention|
16295368|NCT00678197|Other|Bonus/Pay-for-Performance Intervention|
16295369|NCT00678184|Drug|Atorvastatin|80 mg atorvastatin on two following days each
16295370|NCT00678171|Device|TLIF with a PEEK Spacer System and XIA Spinal System|TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.
16295371|NCT00678158|Radiation|intensity modulated radiation therapy|Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
16295372|NCT00678145|Drug|naloxone|Administering naloxone on Day 1, and quantifying the counterregulatory responses to hypoglycemia on Day 2.
16295373|NCT00678145|Dietary Supplement|fructose|Administering fructose on Day 1, and quantifying the counterregulatory responses to hypoglycemia on Day 2.
16295374|NCT00678145|Behavioral|exercise|Administering exercise on Day 1, and quantifying the counterregulatory responses to hypoglycemia on Day 2.
16295375|NCT00678145|Drug|Morphine sulfate|Administering morphine on Day 1, and quantifying the counterregulatory responses to hypoglycemia on Day 2.
16295376|NCT00678145|Drug|Epinephrine|Administering epinephrine on Day 1, and quantifying the counterregulatory responses to hypoglycemia on Day 2.
16295377|NCT00678132|Drug|AZD 2281|
16295378|NCT00678132|Drug|Cisplatin|
16295379|NCT00678132|Drug|Gemcitabine|
16295380|NCT00678119|Biological|AGS-003|Dendritic cell Immunotherapeutic
16295381|NCT00678119|Drug|Sunitinib|An approved drug for the treatment of RCC
16295382|NCT00678106|Drug|Dalbavancin|Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV
16295383|NCT00678093|Other|Application of the SNAG technique|SNAG is a painless and gentle manual technique, mimicking a slide with concurrent active movement, performed in the lumbar spine (in this study) by an experienced manual therapist-physiotherapist.
16295384|NCT00678080|Drug|Metformin|Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
16295385|NCT00678080|Drug|Insulin (NPH and Regular)|Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day
16295386|NCT00678067|Dietary Supplement|Docosahexaenoic acid|Soft capsules 500 mg/each; 1 capsule/day for 4 months
16295387|NCT00678067|Dietary Supplement|Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)|Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
16295388|NCT00678067|Dietary Supplement|Germ oil|Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months
16295389|NCT00678067|Other|National Cholesterol Education Program (NCEP) Step I Diet|Dietary counselling aimed at achieving NCEP Dietary Guidelines: Total fat intake <30% of total calories, Saturated fat intake <10% of total calories, Polyunsaturated fat intake up to 10% of total calories, monounsaturated fat intake 10-15% of total calories
16295390|NCT00678054|Drug|GM-CSF|Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.
16295391|NCT00678041|Drug|Nitrofurantoin|nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
16295392|NCT00678041|Drug|Placebo|Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
16295393|NCT00678015|Drug|Nordihydroguaiaretic Acid (NDGA)|NDGA 2000mg daily
16295394|NCT00677989|Procedure|Laparoscopic appendectomy|laparoscopic appendectomy:did appendectomy by laparoscopic manipulation
16295395|NCT00677989|Procedure|Open appendectomy|open appendectomy: did appendectomy by laparotomy
16295396|NCT00677963|Drug|sulphur hexafluoride, gadopentate dimeglumine|CE-US, using 2 x 2.4 ml sulphur hexafluoride and MRI, using 1 x 0.2 ml/kg gadopentate dimeglumine
16295397|NCT00677950|Procedure|Spinal fusion|Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
16295398|NCT00677937|Behavioral|Modified DESMOND education and ongoing support|6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions
16295399|NCT00677924|Drug|Zalutumumab|Solution for infusion
16295400|NCT00677911|Behavioral|In-vivo pain catastrophizing induction|All participants underwent a 10-minute in-vivo pain castastrophizing induction.
16295401|NCT00677898|Behavioral|Patient-centered computerized tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
16295402|NCT00677898|Behavioral|Written educational materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
16295403|NCT00677872|Drug|PRX-08066|
16295404|NCT00677859|Biological|MultiStem®|Patients will receive a single IV infusion of MultiStem® 2 days after HSCT.
16295405|NCT00677859|Biological|MultiStem®|Patients will receive either 3 weekly IV infusions or 5 weekly infusions of MultiStem®
16295406|NCT00677833|Drug|Azithromycin plus Chloroquine|Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
16295407|NCT00677833|Drug|Artemether-lumefantrine|Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
16295408|NCT00677820|Biological|Trivalent influenza virus vaccine|Trivalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 ml of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10:7 FFU (fluorescent focus units) of each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
16295409|NCT00677820|Biological|Placebo|Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.
16295410|NCT00677807|Drug|Indacaterol|Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
16295411|NCT00677807|Drug|Placebo|Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
16295412|NCT00677794|Drug|Clear fluids|Clear fluids only after lunch.
16295413|NCT00677794|Drug|Picosalax|Two sachets the evening prior to Video Capsule Endoscopy (VCE).
16295414|NCT00677794|Drug|Polyethylene glycol|Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).
16295415|NCT00677768|Other|No intervention|Sample collection
16295416|NCT00677755|Drug|mifepristone combined misoprostol|women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally
16295417|NCT00677755|Drug|misoprostol alone protocol|patients were only administered 0.8 mg of misoprostol orally on day 3.
16295418|NCT00677742|Other|enhanced initial supply of oral contraception|7 packs of pills, or 1 pack of pills and a prescription for 6 refills
16295419|NCT00677742|Other|conventional initial supply of oral contraception|3 packs of pills, or 1 pack of pills and a prescription for 2 refills
16295420|NCT00677729|Drug|solution contains 1 mg salbutamol plus 3% hypertonic saline|4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses
16295421|NCT00677729|Drug|solution contains 1 mg salbutamol plus 0.9% saline|4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses
16295422|NCT00677716|Drug|131I-chTNT-1/B MAb (Cotara)|Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
16295423|NCT00677703|Other|Daily Text Messages|"Text message reminders to take oral contraception daily:
~Each text message will be a short educational message listing the benefits of contraceptive use and providing instructions for avoiding common medication errors."
16295424|NCT00677690|Other|neuromuscular electrical stimulation (NMES)|NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.
16295425|NCT00677690|Other|Sham electrical stimulation|Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
16295426|NCT00677677|Biological|Human papillomavirus quadrivalent vaccine|Patients meeting the inclusion / exclusion criteria will be enrolled from outpatient transplant clinics. Upon enrolment, baseline serum will be obtained and patients will be given the first dose of vaccine. Two months later, serum will again be obtained and the second dose of vaccine will be administered. Finally, at month 6, serum will be obtained and the third dose of vaccine will be given. The final serum samples will be collected at months 7, 12 and 36. At 48 hours and 7 days after each vaccination, patients will be contacted by telephone for local and systemic adverse effect reporting.
16295427|NCT00677664|Drug|Glatiramer acetate (Copaxone)|Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.
16295428|NCT00677664|Drug|Mannitol|Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.
16295429|NCT00677651|Procedure|Adipose Biopsy|Adipose tissue will be sampled from the abdomen and buttock
16295430|NCT00677651|Procedure|Blood sample|Blood will be sampled from an IV line
16295431|NCT00677651|Radiation|CT Scan|Single image at the level of the liver
16295432|NCT00677651|Radiation|DEXA|Whole body scan
16295433|NCT00677638|Device|Ventor Embracer|Implantation of Ventor Embracer
16295434|NCT00677612|Biological|VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy.
16295435|NCT00677599|Dietary Supplement|Flavonoid enrichment (cocoa / soy compounds)|Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment.
16295436|NCT00677599|Dietary Supplement|Flavonoid enrichment (cocoa / soy compounds)|27g placebo chocolate bar to be consumed for 365 days.
16295437|NCT00677586|Procedure|simultaneous resection of liver metastasis and the colorectal primary tumor|simultaneous resection of liver metastasis and the colorectal primary tumor
16295438|NCT00677586|Procedure|staged resection of liver metastasis and the colorectal primary tumor|Patients received resection of the colorectal tumor. 1 months later received resection of liver metastasis
16295439|NCT00677573|Drug|Fostimon|450 IU for 4 days then adjusted
16295440|NCT00677534|Drug|Cholecalciferol|50,000 Units PO Twice weekly for 8 weeks
16295441|NCT00677521|Drug|Acarbose|50mg tablet by mouth daily for the first 2 weeks, then twice a day for the next 2 weeks, and then three times a day for the next 8 weeks for a total of 12 weeks.
16295442|NCT00677495|Dietary Supplement|Gluten-free diet|Gluten-free diet
16295443|NCT00677469|Drug|Cholestyramine|2 grams BID
16295444|NCT00677469|Drug|Cholestyramine|1 gram BID
16295445|NCT00677469|Drug|Placebo powder|1 gram BID
16295446|NCT00677456|Procedure|R-Y reconstruction after total gastrectomy|Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
16295447|NCT00677456|Procedure|P-Y reconstruction after total gastrectomy|Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.
16295448|NCT00677456|Procedure|Pouch reconstruction after total gastrectomy|Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
16295449|NCT00677456|Procedure|P-I reconstruction after total gastrectomy|Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.
16295450|NCT00677443|Drug|S-1 & Oxaliplatin|S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
16295451|NCT00677443|Drug|Capecitabine & Oxaliplatin|COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
16295452|NCT00677430|Behavioral|Questionnaire|A brief questionnaire packet will be completed.
16295453|NCT00677430|Procedure|Digital Imaging|Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
16295454|NCT00677404|Biological|BM-MNC injection|Bone marrow aspiration A total volume of 400 ml bone marrow will be aspirated from the iliac crest under epidural anaesthesia
16295455|NCT00677391|Drug|Sibutramine|Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
16295456|NCT00677391|Drug|Placebo|Capsules, once daily
16295457|NCT00677365|Drug|MP-376|3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
16295458|NCT00677365|Drug|Placebo|same frequency as study drug using the same nebulizer
16295459|NCT00677352|Drug|sertraline|dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
16295460|NCT00677352|Drug|Paroxetine|dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
16295461|NCT00677339|Drug|L-arginine|L-arginine 6g orally daily
16295462|NCT00677339|Drug|Vitamin D|Cholecalciferol 50000 IU once monthly orally
16295463|NCT00677339|Drug|Placebo L-arginine|placebo L-arginine once daily
16295464|NCT00677339|Drug|Placebo Vitamin D|placebo vitamin D orally once monthly
16295465|NCT00677326|Biological|VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16295466|NCT00677313|Drug|metreleptin|metreleptin injection
16295467|NCT00677300|Drug|Raltegravir|400mg P.O. (orally) twice daily for 48 weeks
16295468|NCT00677300|Drug|Darunavir|800 mg P.O. (orally) once daily
16295469|NCT00677300|Drug|Ritonavir|100mg once daily
16295470|NCT00677300|Drug|Tenofovir/Emtricitabine|300 mg/200 mg P.O. (orally) once daily
16295471|NCT00677287|Biological|RNF43, TOMM34, VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, RNF43 peptide (1mg), TOMM34 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy.
16295472|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the onset of regular uterine contraction
16295473|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 0.5cm
16295474|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 1.0cm
16295475|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 1.5cm
16295476|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 2.0cm
16295477|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 3.0cm
16295478|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 4.0cm
16295479|NCT00677274|Procedure|Epidural labor analgesia|Epidural analgesia initiated at the cervix diameter 5.0cm
16295480|NCT00677261|Procedure|Sciatic Nerve Block|Patients randomized to Group 1 will receive a single sciatic nerve block using the infragluteal parabiceps approach, using 20 ml of 0.5 % Ropivacaine. A sham injection of the posterior capsule and fat pad using 50 cc of normal saline will be conducted at the conclusion of the surgery.
16295481|NCT00677261|Procedure|Posterior capsule infiltration with local anesthetic|Patients randomized to Group 2 will receive a Sham sciatic nerve block using 20cc of normal saline as described above as well as extensive local anesthetic infiltration of the posterior capsule and fat pad with a solution of 50 ml of 0.2% ropivicaine.
16295482|NCT00677261|Procedure|Sham sciatic block and sham posterior infiltration|Patients randomized to group 3 will only receive a continuous femoral nerve catheter, A sham sciatic nerve block with 20cc of normal saline as well as a sham injection of the posterior capsule and fat pad will be performed with 50cc of normal saline.
16295483|NCT00677248|Drug|Ezetimibe and placebo|Placebo or three different doses of eprotirome added to ezetimibe treatment
16295484|NCT00677248|Drug|Eprotirome and ezetimibe|Placebo or three different doses of eprotirome added to ezetimibe treatment
16295485|NCT00677235|Device|FLAIR Endovascular Stent Graft|Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
16295486|NCT00677235|Procedure|PTA|Treatment of stenoses with PTA only
16295487|NCT00677222|Biological|AMI MultiStem®|AMI MultiStem® administered via catheter into peri-vascular space of the target vessel, 2-5 days post PCI. There will be 3 dose escalation cohorts, 6 patients per cohort.
16295488|NCT00677209|Biological|Injection of autovaccine (Autovaccine Symbiopharm)|increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
16295489|NCT00677196|Device|The stonebreaker arm (LMA Stonebreaker)|The interventional device name is the LMA Stonebreaker pneumatic handheld lithotriptor.
16295490|NCT00677196|Device|Pneumatic Lithotripsy (Swiss LithoClastR)|Pneumatic lithotripsy, the Swiss LithoClastR during percutaneous nephrolithotripsy (PNL)
16295491|NCT00677170|Drug|MLN4924|IV dose escalation for 5 consecutive days followed by a rest period of 16 days for a 21 day cycle. Treated may continue until disease progression or unacceptable toxicity develops.
16295492|NCT00677144|Drug|OS (oxalipaltin+S-1)|Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
16295493|NCT00677144|Drug|XELOX (oxalipaltin+capecitabine)|Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
16295494|NCT00677131|Other|Reading the package insert of the drug|package insert of the drug
16295495|NCT00677131|Other|Reading the education information provided by the Pharmacy of NTUH|education information
16295496|NCT00677131|Other|Oral education provided by the pharmacist|Oral education provided by the pharmacist
16295497|NCT00677118|Drug|Cisplatin,fluorouracil|Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.
16295498|NCT00677118|Drug|Cisplatin|Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.
16295499|NCT00677105|Drug|JNJ-26481585|
16295500|NCT00677092|Drug|Imatinib mesylate|400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia.
16295501|NCT00677079|Drug|Iniparib|"Body weight adjusted dose
~1 hour intravenous infusion"
16295502|NCT00677066|Procedure|Home oxygen therapy|Administer oxygen at home or in hospital
16295503|NCT00677053|Drug|TAK-442|Stage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295504|NCT00677053|Drug|TAK-442|Stage I: TAK-442 20 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295505|NCT00677053|Drug|TAK-442|Stage I: TAK-442 40 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
16295506|NCT00677053|Drug|TAK-442|Stage II: TAK-442 40 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295507|NCT00677053|Drug|TAK-442|Stage II: TAK-442 80 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
16295508|NCT00677053|Drug|TAK-442|Stage II: TAK-442 80 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295509|NCT00677053|Drug|TAK-442|Stage III: TAK-442 160 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
16295510|NCT00677053|Drug|TAK-442|Stage III: TAK-442 120 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295511|NCT00677053|Drug|Placebo|Stages I, II & III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
16295512|NCT00677027|Other|lentinan|Five dose levels of escalating concentrations of the test substance will be tested during the study periode. All patients will recieve each dose, which is to be taken daily for two weeks.
16295513|NCT00677027|Other|placebo|Placebo
16295514|NCT00677014|Device|AV Delay programming through cardiac resynchronization therapy|"All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm."
16295515|NCT00677014|Device|AV Delay programming through cardiac resynchronization therapy|"All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm."
16295516|NCT00677014|Device|AV Delay programming through cardiac resynchronization therapy|"All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm."
16295517|NCT00677001|Drug|R306465|
16295518|NCT00676975|Drug|Traditional Chinese Medicine|"A herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage.
~The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale"
16295519|NCT00676975|Drug|Traditional Chinese Medicine Placebo|Placebo once daily for 8 weeks
16295520|NCT00676962|Behavioral|External facilitation|Study facilitator meets regularly with therapists to aid implementation of CBT
16295704|NCT00675701|Drug|moxifloxacin|tablets
16295521|NCT00676949|Biological|5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1|1mg each of 5 peptides with IFA. 4 weekly s.c. administration.
16295522|NCT00676936|Drug|Methylprednisolone|Custom made capsules, Methylprednisolone 16 mg twice daily, intervention period 7 days.
16295523|NCT00676936|Drug|Placebo|Custom made capsules, Lactose, administered twice daily, intervention period 7 days
16295524|NCT00676910|Drug|JNJ-26854165|
16295525|NCT00676897|Drug|Simvastatin|Simvastatin 40mg PO or NGT
16295526|NCT00676897|Drug|Placebo|Corn Starch
16295527|NCT00676884|Drug|Aeroderm (also known as pitrakinra, AER 001, BAY 16-9996)|30 mgs s.c. b.i.d.
16295528|NCT00676884|Drug|placebo|1.5 mL s.c. b.i.d.
16295529|NCT00676871|Drug|MEDI-538|Dose one of MEDI 538 as a continuous IV infusion - dose level is 5 mg/m2/24h (Phase 1)
16295530|NCT00676871|Drug|MEDI-538|Dose two of MEDI 538 as a continuous IV infusion - dose level is 10 mg/m2/24h (Phase 1)
16295531|NCT00676871|Drug|MEDI-538|Dose three of MEDI 538 as a continuous IV infusion-dose level is 15mg/m2/24h (Phase 1)
16295532|NCT00676871|Drug|MEDI-538|Dose four of MEDI 538 as a continuous IV infusion - dose level is 30 mg/m2/24h(Phase 1)
16295533|NCT00676871|Drug|MEDI-538|Dose five of MEDI 538 as a continuous IV infusion - dose level is 45 mg/m2/24h (Phase 1)
16295534|NCT00676871|Drug|MEDI-538|Dose six of MEDI 538 as a continuous IV infusion - dose level is 60 mg/m2/24h (Phase 1)
16295535|NCT00676871|Drug|MEDI-538|Phase 2 part of the study, 20 to 60 patients will be treated with MEDI 538 as a continuous IV infusion through a central line catheter. The dose of MEDI-538 will be determined in the Phase 1 part of the study.
16295536|NCT00676845|Drug|olmesartan medoxomil|dosage form: oral tablet; frequency: daily; duration: 52 weeks
16295537|NCT00676845|Drug|placebo|dosage form: tablet; frequency: daily; duration: 3 weeks
16295538|NCT00676845|Drug|olmesartan medoxomil|dosage form: oral tablet; frequency: daily; duration: 52 weeks
16295539|NCT00676845|Drug|olmesartan medoxomil|dosage form: oral tablet; frequency: daily; duration: 52 weeks
16295540|NCT00676832|Drug|Placebo|Placebo solid capsule dosage form administered orally once daily.
16295541|NCT00676832|Drug|COLAL-PRED|The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
16295542|NCT00676819|Drug|insulin aspart|
16295543|NCT00676819|Drug|human insulin|
16295544|NCT00676806|Biological|Umbilical Cord Blood After Myeloablative Conditioning|cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0.
16295545|NCT00676806|Biological|Umbilical Cord Blood After Reduced-Intensity Conditioning|Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.
16295546|NCT00676793|Drug|Polyphenon E|Four 200mg capsules daily taken with a meal, for the duration of the study.
16295547|NCT00676780|Drug|Polyphenon E (EGCG)|4 capsules daily with a meal for the duration of the study
16295548|NCT00676767|Dietary Supplement|Resistant Starch Type 4|
16295549|NCT00676767|Dietary Supplement|Dextrose|
16295550|NCT00676767|Dietary Supplement|Puffed wheat|
16295551|NCT00676754|Procedure|Statens Serum Institut RT23 2TU tuberculin|
16295552|NCT00676741|Drug|insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16295553|NCT00676741|Drug|biphasic insulin aspart 30|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16295554|NCT00676741|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16295555|NCT00676728|Drug|JNJ-26481585|In Part 1, Initial dose of JNJ-26481585 4 mg oral capsule is administered once daily on each day of a 21-day cycle. Dose will be escalated or de-escalated until Maximum tolerated dose (MTD) of JNJ-26481585 is determined in Part 1. MTD of JNJ-26481585 will be the initial dose in Part 2.
16295556|NCT00676715|Drug|Placebo|Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
16295557|NCT00676715|Drug|Ocrelizumab|Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
16295558|NCT00676715|Drug|Avonex|Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
16295559|NCT00676702|Dietary Supplement|Ensure Plus|A high-fat liquid meal of 500 ml of Ensure Plus
16295560|NCT00676702|Drug|Pancrelipase in combination with Ensure Plus|3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus.
16295561|NCT00676689|Device|SAPIEN Transcatheter Valve Implantation|Device Implantation
16295562|NCT00676676|Drug|Testosterone|Testosterone atch delivering 300mcg daily for 8-weeks
16295563|NCT00676663|Drug|entinostat|Entinostat 5 mg tablet orally once per week
16295564|NCT00676663|Drug|exemestane|Exemestane 25 mg tablet orally once daily
16295565|NCT00676663|Drug|Placebo|Placebo-matching entinostat tablet orally once per week
16295566|NCT00676650|Drug|Prednisone|5 mg BID, oral
16295567|NCT00676650|Drug|sunitinib|37.5 mg/day, oral, administered on a continuous daily dosing regimen
16295568|NCT00676650|Drug|Placebo|37.5 mg/day, oral, administered on a continuous daily dosing regimen
16295569|NCT00676650|Drug|Prednisone|5 mg BID, oral
16295570|NCT00676637|Drug|Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)|One drop in study eye(s) once daily in the evening for four months
16295571|NCT00676637|Device|Travalert Dosing Aid|Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence
16295572|NCT00676585|Drug|Normal Saline|Normal Saline
16295573|NCT00676585|Drug|Hydrocortisone|Hydrocortisone 100mg
16295574|NCT00676572|Other|Fiberoptic bronchoscopy; blood test|Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
16295705|NCT00675688|Drug|Bazedoxifene/Conjugate Estrogens (CE)|
16295575|NCT00676559|Drug|Efalizumab|Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.
16295576|NCT00676559|Drug|Ranibizumab|Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).
16295577|NCT00676533|Drug|Cipro XR (Ciprofloxacin, BAYQ3939)|3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.
16295578|NCT00676520|Device|XIENCE V® Everolimus Eluting Coronary Stent|Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
16295579|NCT00676507|Biological|Lucanix™|Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
16295580|NCT00676507|Other|Placebo Comparator|Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
16295581|NCT00676494|Device|Pathway PV Atherectomy System|The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.
16295582|NCT00676481|Behavioral|HIV risk education|Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED
16295583|NCT00676468|Other|Active Montelukast + Fish Oil Placebo|Montelukast (1 x 10 mg tablet) per day + 10 tablets of fish oil placebo (soy bean oil) per day for a duration of 3 weeks
16295584|NCT00676468|Other|Active Fish Oil + Montelukast Placebo|10 tablets (3.2 g EPA + 2.0 g DHA) per day and 1 x 10 mg Montelukast Placebo tablet per day for a duration of 3 weeks.
16295585|NCT00676468|Other|Active Montelukast + Active Fish Oil|1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.
16295586|NCT00676442|Drug|PN400|naproxen/esomeprazole
16295587|NCT00676429|Drug|Ziprasidone Hydrochloride|Ziprasidone Hydrochloride oral solution, individual titration 5 mg o.d. or 10 mg to 40 mg b.i.d
16295588|NCT00676429|Drug|Placebo|Placebo as oral solution, individually titrated
16295589|NCT00676416|Drug|2,6-Diisopropylphenol|Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
16295590|NCT00676403|Drug|placebo|Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
16295591|NCT00676403|Drug|Pregabalin|50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
16295592|NCT00676403|Drug|Pregabalin|100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
16295593|NCT00676403|Drug|Pregabalin|150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
16295594|NCT00676403|Drug|Pregabalin|300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
16295595|NCT00676403|Drug|Pregabalin|450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
16295596|NCT00676390|Other|doubly labelled water and questionnaire|0.075 g.kg-1 and 2H2O et 0.15 g.kg-1 de H218O per oral at inclusion visit. physical activity questionnaire at inclusion visit
16295597|NCT00676377|Drug|Neostigmine|2.5 mg of neostigmine intravenously in 250 ml normal saline over a period of thirty minutes ,Half Life 3 Hours
16295598|NCT00676377|Drug|Saline|Saline Placebo
16295599|NCT00676364|Drug|4% lidocaine topical anesthetic cream|A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
16295600|NCT00676364|Drug|Placebo cream|A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
16295601|NCT00676351|Procedure|body plethysmography|Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system
16295602|NCT00676338|Drug|exenatide once weekly|subcutaneous injection, 2mg, once weekly plus placebo oral once daily
16295603|NCT00676338|Drug|metformin|oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
16295604|NCT00676338|Drug|sitagliptin|oral, 100 mg, daily plus placebo once weekly subcutaneous injection
16295605|NCT00676338|Drug|pioglitazone|oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
16295606|NCT00676325|Procedure|Surgical treatment of Anterior Vaginal Prolapse|seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.
16295607|NCT00676325|Device|NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.|Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
16295608|NCT00676325|Procedure|surgical treatment for anterior vaginal wall prolapse|Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.
16295609|NCT00676312|Drug|PTH134|
16295610|NCT00676299|Drug|JNJ-26483327|
16295611|NCT00676286|Procedure|3T MR Imaging|3TR Imaging
16295612|NCT00676286|Procedure|C-Choline PET Scanning|C-Choline PET Scanning
16295613|NCT00676286|Procedure|Gene Rearrangement|Gene Rearrangement
16295614|NCT00676273|Device|TVT-Obturator (TVT-O)|sub urethral sling
16295615|NCT00676273|Device|TVT-Secur (TVT-S) (Hammock method)|suburethral sling
16295616|NCT00676260|Drug|Pioglitazone|Pioglitazone 15 mg to 30 mg, tablets, orally, once daily for up to 10 weeks
16295617|NCT00676260|Drug|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 10 weeks
16295618|NCT00676234|Drug|epoetinum|Administration of intravenous rhu Epo on Day 0 20000 IU rhu Epo (20 patients) administered by the i.v. route 40000 IU rhu Epo (20 patients) administered by the i.v. route
16295619|NCT00676221|Drug|Myfortic|"Mycophenolate Mofetil (Cellcept) discontinued at Baseline visit. Mycophenolate Sodium(Myfortic)commenced the following day at equimolar doses orally BID.
~Cellcept 1000mg bid = Myfortic 720mg bid"
16295620|NCT00676208|Behavioral|Shared Medical Appointments|Participated in shared appointments for patients as part of interprofessional team providing care for diabetes
16295706|NCT00675688|Drug|Raloxifene|
16295621|NCT00676195|Drug|N-Acetyl Cysteine|"Dosage of orally administered N-Acetyl Cysteine is as follows:
~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
16295622|NCT00676182|Other|Telerehabilitation|Rehabilitation via computer assisted internet capabilities
16295623|NCT00676156|Drug|oral lipoic acid (LA)|A single 1200 mg dose of oral LA will be administered.
16295624|NCT00676156|Drug|lipoic acid (LA) with fish oil and LA without fish oil|Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over.
16295625|NCT00676156|Drug|R lipoic acid|A single oral dose of 1200mg R enantiomer LA will be administered.
16295626|NCT00676143|Drug|bapineuzumab|Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
16295627|NCT00676143|Drug|placebo|Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
16295628|NCT00676130|Drug|trimethoprim-sulfamethoxazole|"Weight-based dosing in capsule or suspension form according to the following scale:
~15-19 kg (33-42 lbs): trimethoprim-sulfamethoxazole 40/200 mg four times daily
~20-24 kg (42-53 lbs): trimethoprim-sulfamethoxazole 60/300 mg four times daily
~25-29 kg (53-64 lbs): trimethoprim-sulfamethoxazole 72/360 mg four times daily
~29-60 kg (64-132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily
~60 kg (132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily
~60-80 kg (132-176 lbs): trimethoprim-sulfamethoxazole 160/800 mg three times daily
~> 80 kg (176 lbs): trimethoprim-sulfamethoxazole 160/800 mg four times daily"
16295629|NCT00676130|Drug|Cephalexin|"Weight-based dosing in capsule or suspension form according to the following scale:
~15-19 kg (33-42 lbs): Cephalexin 300 mg four times daily
~20-24 kg (42-53 lbs): Cephalexin 400 mg four times daily
~25-29 kg (53-64 lbs): Cephalexin 500 mg four times daily
~29-60 kg (64-132 lbs): Cephalexin 500 mg four times daily
~60-80 kg (132-176 lbs): Cephalexin 1000 mg three times daily
~> 80 kg (176 lbs): Cephalexin 1000 mg four times daily"
16295630|NCT00676117|Drug|Esomeprazole (D961H)|20mg
16295631|NCT00676117|Drug|Loxoprofen|60mg tablet
16295632|NCT00676104|Device|CoolSystems Discrete Cerebral Hypothermia System|The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
16295633|NCT00676091|Biological|13-Valent Pneumococcal Conjugate Vaccine (13vPnC)|
16295634|NCT00676091|Biological|7-Valent Pneumococcal Conjugate Vaccine (7vPnc)|
16295635|NCT00676052|Drug|GSK233705 12.5mcg|Once daily via dry powder inhaler
16295636|NCT00676052|Drug|GSK233705 25mcg|once daily via dry powder inhaler
16295637|NCT00676052|Drug|GSK233705 50mcg|Once daily via dry powder inhaler
16295638|NCT00676052|Drug|GSK233705 100mcg|Once daily via dry powder inhaler
16295639|NCT00676052|Drug|GSK233705 200mcg|Once daily via dry powder inhaler
16295640|NCT00676052|Drug|Placebo|Once daily via dry powder imhaler
16295641|NCT00676039|Drug|Venlafaxine|NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)
16295642|NCT00676039|Drug|Gen-Citalopram|Gen-Citalopram 40 mg (Genpharm, Generic)
16295643|NCT00676039|Drug|Effexor XR|Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)
16295644|NCT00676039|Drug|Celexa|Celexa 40 mg (Lundbeck, Brand Name)
16295645|NCT00676026|Drug|Fluoxetine|Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
16295646|NCT00676026|Drug|Zolpidem|Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
16295647|NCT00676026|Drug|Progesterone|Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.
16295648|NCT00676013|Procedure|Integra|Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
16295649|NCT00676013|Procedure|AlloDerm|Grafting using the commercial product AlloDerm as a skin substitute
16295650|NCT00676013|Procedure|Homograft|Grafting using homograft as a skin substitute
16295651|NCT00676013|Procedure|Autograft|grafting using patients own skin from a separate donor site
16295652|NCT00676000|Procedure|Interrupted vaginal closure|Horizontal mattress closure of vaginal mucosa over mesh
16295653|NCT00676000|Procedure|Continuous vaginal closure|Running closure of vaginal mucosa over mesh
16295654|NCT00675987|Drug|losartan|losartan 100 mg tablets 1 tab po QD
16295655|NCT00675987|Drug|Placebo control|Placebo 1 po QD
16295656|NCT00675974|Device|Jobst Pressure Garment|Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.
16295657|NCT00675974|Device|Medical Z pressure garment|Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.
16295658|NCT00675961|Behavioral|Brief Counseling Intervention (BCI)|Two-tiered BCI characterized by both primary and secondary interventions. Primary BCI treatment format consists of 6 discussions delivered monthly in the first 6 months of standard TB treatment. 10-15 minutes long. Secondary BCI is delivered on a monthly basis while receiving TB treatment. 5-10 minutes long.
16295659|NCT00675961|Drug|Naltrexone|Opioid antagonist, which decreases the pleasurable response to and craving for alcohol consumption. Oral; single daily dose of 50 mg per day for 6 months.
16295660|NCT00675961|Other|BCI + Naltrexone|Combination of the two previous interventions
16295661|NCT00675961|Behavioral|Treatment as Usual|Services provided by psychologists and narcologists (additions specialists) employed by the Tomsk Oblast TB Services.
16295662|NCT00675948|Drug|Sativex|"Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both as extract of Cannabis sativa L.
~Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours."
16295663|NCT00675948|Drug|GW-2000-02|Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
16295707|NCT00675688|Drug|Placebo|
16295708|NCT00675675|Behavioral|Comprehensive Behavioral Intervention for Tics (CBIT)|Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.
16295664|NCT00675935|Other|Fall Prevention Tool Kit prototype using a randomized design|Based on the results from Phase 1, Phase 2 and consistent with the literature that suggests that multifaceted, tailored interventions are most effective against inpatient falls, the FPTK prototype will be comprised of two interrelated components 1) The Fall Risk Alert and Communication Plan (translates an individual patient's fall risk assessment into a decision support intervention that communicates fall risk status to team members.) and 2) The Patient Safety Plan of Care PSPOC (translates an individual patient's fall risk assessment into a decision support intervention that creates a tailored evidence-based plan of care). The goal of the FPTK Intervention is to communicate risk status and recommended tailored discipline specific-interventions to prevent falls.
16295665|NCT00675922|Drug|Sulfamylon 5% and Silver Nitrate Soaks|Application of Sulfamylon and Silver Nitrate Solution to burn wound daily
16295666|NCT00675909|Drug|Aerosolized Intranasal midazolam|"Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
16295667|NCT00675909|Drug|Aerosolized Buccal Midazolam|"0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
16295668|NCT00675909|Drug|Oral midazolam|oral midazolam 0.5mg/kg
16295669|NCT00675896|Drug|Quetiapine Fumarate Sustained Release|50 mg/day for the first 2 days and then up to 150mg/day. After two weeks the dose will be doubled up to 300mg at night at the discretion of the investigator
16295670|NCT00675896|Drug|Placebo|1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks
16295671|NCT00675870|Drug|NRX 195183 Soft Gelatin Capsule|Daily oral NRX 195183 administration for 90 days to assess CR rate. Patients with CR may continue maintenance therapy after a 2-week drug holiday. Maintenance therapy will consist of two 3-month daily oral NRX 195183 administration separated by a 2-week drug holiday.
16295672|NCT00675857|Drug|NC-503 (eprodisate disodium)|capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
16295673|NCT00675857|Other|placebo|Dosage: 4 capsules BID for 26 weeks
16295674|NCT00675844|Drug|elvucitabine|10 mg elvucitabine daily as part of an ART regimen
16295675|NCT00675831|Device|CliniMACS CD25 Reagent Device|Used to engineer CD25+ depleted donor lymphocytes which will be infused intravenously over 5-10 minutes
16295676|NCT00675818|Device|Continuous venvenous hemofiltration (CVVH)|Continuous venovenous hemofiltration with a replacement fluid rate of 35 mL/kg/hr.
16295677|NCT00675818|Device|Continuous venovenous hemodialysis (CVVHD)|Continuous venovenous hemodialysis at a dialysate flow rate of 35 mL/kg/hr.
16295678|NCT00675805|Device|Infusomat filter (Codan Duofilter-Set V86-P)|An approved filter system may be efficient in retaining complement activating IgG aggregates in IVIG preparations. This effect may reduce complement activation and consecutive inflammation thereby diminishing adverse events during application of intravenous immunoglobulins.
16295679|NCT00675805|Device|IVIG application without filter (Placebo)|Application Intravenous immunoglobulins without filter (Placebo)
16295680|NCT00675792|Drug|Sugammadex|Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide.
16295681|NCT00675792|Drug|Neostigmine|Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.
16295682|NCT00675792|Drug|Rocuronium|Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.
16295683|NCT00675779|Drug|oral contraceptive (Mercilon)|oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
16295684|NCT00675779|Drug|atorvastatin + oral contraceptive|atorvastatin 20mg po a day for 6 months + oral contraceptive (20ug EE, 150ug DSG) 1 tablet po a day for 21 days with 7 day break for 6 months
16295685|NCT00675753|Genetic|Blood spot specimens will be drawn|Blood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping
16295686|NCT00675740|Drug|rosiglitazone|tablets 4 mg daily
16295687|NCT00675740|Behavioral|physical exercise|stationary bike 5-6 times a week
16295688|NCT00675740|Other|control|control without intervention
16295689|NCT00675727|Biological|CADI-05|Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks.
16295690|NCT00675714|Procedure|Stable Isotope Infusion Study|1-8 hour stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues.
16295691|NCT00675714|Procedure|Collection of blood and tissues|Blood draw with each stable isotope infusion study and weekly Tissue biopsy: skin, fat, muscle at stable isotope infusion study
16295692|NCT00675714|Procedure|Radiology testing: Dual-energy X-ray absorptiometry (DEXA), ultrasound, MRI|Testing to be done following every stable isotope infusion study to measure muscle, fat and bone tissues.
16295693|NCT00675714|Drug|Humatrope|Humatrope (Growth Hormone) dose:0.05mg - 0.2mg/kg/day SQ daily for up to 2 years post burn injury.
16295694|NCT00675714|Drug|Ketoconazole|Ketoconazole administration (or other glucocorticoid blocker--itraconazole or fluconazole) PO daily for up to 2 years post burn injury
16295695|NCT00675714|Drug|Oxandrolone|oxandrolone (or other anabolic steroid-testosterone or nandrolone) daily for up to 2 years post burn injury
16295696|NCT00675714|Drug|Propranolol|Propranolol (or other beta adrenergic blocker--metoprolol, inderol), PO administration daily for up to 2 years post burn injury.
16295697|NCT00675714|Drug|Oxandrolone and propranolol combined|Daily administration of oxandrolone and propranolol to be given for up to 2 years post burn injury.
16295698|NCT00675714|Drug|Humatrope and propranolol combined|Humatrope (growth hormone) and propranolol administration daily for up to 2 years post burn injury.
16295699|NCT00675714|Drug|Placebo|placebo to be given once a day for up to two years post burn injury.
16295700|NCT00675714|Behavioral|Exercise--Hospital supervised intensive exercise program|intensive exercise program supervised by trained personnel in the hospital environment for six up to twelve week program.
16295701|NCT00675714|Behavioral|Home exercise program|Home intensive exercise program: training occurs in hospital then patient sent home to continue exercise program for six weeks and up to 12 weeks at home.
16295702|NCT00675701|Drug|placebo|capsules
16295703|NCT00675701|Drug|lixivaptan|capsules
16295709|NCT00675675|Behavioral|Minimal Contact Waitlist|Bimonthly phone check-in to assess clinical status and enhance subject retention
16295710|NCT00675662|Behavioral|Lifestyle intervention|Lifestyle intervention with Trim Tots pre-school programme.
16295711|NCT00675662|Behavioral|waiting list control|waiting list control
16295712|NCT00675649|Biological|CNTO 148 / Golimumab|100 mg sc injection every 4 weeks from week 0 to week 20
16295713|NCT00675649|Biological|placebo|placebo sc injection every 4 weeks from week 0 to week 20
16295714|NCT00675636|Other|study of socioeconomic and demographic variables|database, no intervention
16295715|NCT00675636|Procedure|evaluation of cancer risk factors|database, no intervention
16295716|NCT00675636|Procedure|study of high risk factors|database, no intervention
16295717|NCT00675623|Drug|Dimebon|Dimebon, 5 mg orally three times daily for six months
16295718|NCT00675623|Drug|Dimebon|Dimebon 20 mg orally three times daily for six months
16295719|NCT00675623|Drug|Placebo|Placebo three times daily for six months
16295720|NCT00675610|Behavioral|communication training|providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
16295721|NCT00675597|Drug|Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)|Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.
16295722|NCT00675584|Drug|Budesonide|Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.
16295723|NCT00675584|Drug|Placebo Budesonide|Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.
16295724|NCT00675558|Procedure|Initial Surgery|"NO patients had initial abdominal laparoscopic surgery at study entry, during which research fat biopsies were obtained, completing their participation.
~MO patients had initial laparoscopic bariatric surgery (gastric bypass, adjustable gastric band, or sleeve gastrectomy) and fat biopsies at entry, completing their participation.
~All 30 SMO patients had initial laparoscopic bariatric surgery (sleeve gastrectomy) & fat biopsies. The first 10 to lose 100 lbs but who needed further surgery to reach optimal weight and who consented to further surgery underwent a 2nd laparoscopic bariatric surgery (either a biliopancreatic diversion with duodenal switch or a Roux-en-Y gastric bypass) and biopsies. The interval between surgeries averaged 15 mos. and the weight loss 55 kg. 30 SMO patients were initially enrolled to insure that 10 would complete 2 surgeries. When 10 had had their 2nd operation, the study was considered complete, and the remaining 20 SMO participants were so notified."
16295725|NCT00675558|Procedure|Second Bariatric Surgery|A second bariatric procedure was performed on only 10 of the original 30 Super-morbidly Obese (SMO) subjects.
16295726|NCT00675545|Drug|Docetaxel, Carboplatin|"Docetaxel Form: A white, lyophilized powder in vials of 50, 150, and 450 mg each, which should be stored at room temperature in a light-protected area.
~Carboplatin Form: Taxotere is supplied as a sterile, non-aqueous, viscous solution with an accompanying sterile diluent (13% ethanol in water for injection). 20 and 80 mg strengths are available."
16295727|NCT00675532|Behavioral|Primary Care Counseling|Subjects in this condition will attend bi-weekly 15 minute sessions with the study nurse for primary care counseling which is a brief manual-guided, medically focused counseling approach to the treatment of opioid dependent individuals seen in primary care settings. The brief counseling sessions involve repeated support for and monitoring of medication compliance, and the provision of advice regarding established methods for coping with psychological and social factors that lead to drug use.
16295728|NCT00675532|Behavioral|Cognitive-behavioral psychotherapy|Subjects in the CBT condition will participate in bi-weekly 50-minute-long individualized cognitive-behavioral psychotherapy sessions with a CBT trained clinician. The general purpose of the therapy is to: (1) acquire information about important concepts and aspects of recovery from opioid addiction; (2) increase self-awareness of specific problems and issues in relation to addiction and recovery, and (3) learn new coping skills to deal with problems contributing to or resulting from the addiction and to improve overall psychosocial functioning. The primary focus of this approach is to provide patients with frequent supportive contact and to teach cognitive-behavioral relapse prevention skills.
16295729|NCT00675519|Behavioral|Motivational enhancement therapy|Motivational enhancement therapy begins with the assumption that the responsibility and capacity for change lie within the client. The therapist begins by providing individualized feedback about the effects of the patient's drinking. Working closely together, therapist and patient explore the benefits of abstinence, review treatment options, and design a plan to implement treatment goals.
16295730|NCT00675506|Drug|Growth hormone releasing hormone (GHRH) 1-44|2-mg sub-cutaneous injections once daily for 12 months
16295731|NCT00675506|Drug|Placebo|2-mg sub-cutaneous injections once daily for 12 months
16295732|NCT00675493|Drug|biphasic insulin aspart 30|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
16295733|NCT00675480|Procedure|Thrombectomy|Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
16295734|NCT00675480|Procedure|Primary angioplasty|Standard primary angioplasty with stent implantation
16295735|NCT00675467|Behavioral|Focus Group - Parent/Caregiver|A 1 1/2 hour group session with other parents/caregivers.
16295736|NCT00675467|Behavioral|Focus Group - Pediatric Patient|A 1 1/2 hour group session with other pediatric patients.
16295737|NCT00675441|Drug|Lenalidomide|10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
16295738|NCT00675428|Drug|BG00002 (natalizumab)|
16295739|NCT00675415|Diagnostic Test|Capnography|Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity
16295780|NCT00675077|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
16295781|NCT00675064|Drug|GSK369796|Anti-malarial
16295740|NCT00675402|Other|supervised treadmill exercise program|Supervised treadmill therapy consists of a walking exercise on a treadmill under supervision of a physiotherapist, 2-3 times a week. This program is combined with individual walking every other day and the total duration of the program is 6 months. Guided by the painfree walking distance, every month the angle and/or speed of the treadmill will increase. A standardized protocol for this type of therapy is already in use by many physiotherapists in Limburg (Willigendael, 2005).
16295741|NCT00675389|Behavioral|Peer Health Workers Intervention|Peer health workers are themselves PLWHA on ART who have demonstrated good ART adherence for at least 6 months. The peers are responsible for ~15-20 patients and are expected to visit the patients in their homes once every two weeks. At these visits, peers record a review of symptoms, client self-report of adherence, and a pill count. At the clinic, peers assist with patient organization and share their experiences, particularly with patients about to start ART. Peer health workers undergo an initial, intensive two day residential training course and are provided with a bike and basic supplies, and a modest amount of remuneration to encourage compliance with their responsibilities and promote a high program retention rate.
16295742|NCT00675389|Behavioral|Peer Health Workers and Mobile Phone Intervention|In addition to the peer health worker intervention, this arm adds a mobile phone intervention consisting of the following: during home visits, peers with mobile phones, using data collected on their home visit forms, send real-time text messages containing this clinical and adherence data back to the central clinic to be reviewed by clinical staff within a 24 hour period. Peers may also call, toll-free, back to a central clinic Warmline with any questions or concerns.
16295743|NCT00675363|Procedure|Protocolized Sedation|Nurse-directed protocol for administering sedation and/or analgesia.
16295744|NCT00675363|Procedure|Protocolized sedation, with daily interruption|Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
16295745|NCT00675350|Drug|Omacetaxine|1.25 mg/m2 subcutaneous twice daily for 14 days
16295746|NCT00675337|Procedure|perineum maintained|infants maintained at the level of the perineum until umbilical cord clamping
16295747|NCT00675337|Procedure|abdominal placement|infants placed on the maternal abdomen prior to umbilical cord clamping
16295748|NCT00675324|Drug|Laxabon|Laxabon 4 litres, starting the day (e.m.) before the colonoscopy
16295749|NCT00675324|Dietary Supplement|Fresubin Energy drink|30 kcal/kg*day five days before colonoscopy
16295750|NCT00675311|Behavioral|DM-Standard|Device/t+ Medical Diabetes Management System
16295751|NCT00675311|Behavioral|Disease Management Plus|Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
16295752|NCT00675285|Drug|montelukast sodium|one tablet 5 mg once/day for 4 weeks
16295753|NCT00675285|Drug|placebo|one tablet 5 mg once/day for 4 weeks
16295754|NCT00675272|Drug|hydrocortisone|hydrocortisone 50mg iv. every 6 hours
16295755|NCT00675272|Drug|sodium chloride|sodium chloride every 6 hours iv
16295756|NCT00675259|Drug|bevacizumab|bevacizumab 10 mg/kg on days 1 and 15 administered every 28 days [1 cycle] for 5 cycles
16295757|NCT00675259|Drug|carboplatin|AUC 2 IV on days 1, 8, and 15
16295758|NCT00675259|Drug|nab-paclitaxel|100 mg/M2 IV
16295759|NCT00675259|Procedure|Surgery|lumpectomy or mastectomy along with axillary lymph node dissection approximately 4-5 weeks after completion of NCT.
16295760|NCT00675259|Drug|Adjuvant chemotherapy|All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab at 15 mg/kg IV every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
16295761|NCT00675246|Drug|Betamethasone|IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
16295762|NCT00675233|Drug|HPPH|Given IV
16295763|NCT00675233|Procedure|laser therapy|Escalating light doses with 665 nm light
16295764|NCT00675220|Drug|insulin aspart|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16295765|NCT00675207|Drug|Brimonidine purite 0.15%|A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
16295766|NCT00675207|Drug|Dorzolamide 2%|A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
16295767|NCT00675207|Drug|Brinzolamide 1%|A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.
16295768|NCT00675194|Drug|Cisplatin, Irinotecan, Capecitabine|
16295769|NCT00675181|Drug|Melatonin|5mg per os
16295770|NCT00675181|Drug|Placebo|per os
16295771|NCT00675168|Radiation|PET/CT (low-dose)|400 mBq 18F-flour-deoxyglucose given iv. 60 min. before PET/CT-scan
16295772|NCT00675155|Radiation|Far Infrared Radiation|Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.
16295773|NCT00675142|Procedure|Intrauterine Insemination|Changing the time span between ovulation induction and IUI during fertility treatment.
16295774|NCT00675129|Behavioral|Dialectical behavioral therapy for adolescents (DBT-A)|"Patients randomised to DBT-A will receive 16 weeks treatment, with one weekly session (60 minutes)of individual therapy, one weekly session of multifamily skills training (120 minutes), and telephone coaching outside therapy sessions.
~The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus & Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively."
16295775|NCT00675129|Behavioral|Treatment as usual|Patients randomised to EUC will received standard care (16 weeks) at five participating child and adolescent outpatient clinics from therapists not trained in or practising DBT. According to pilot study data EUC will most likely consist of psychodynamic therapy, various forms of family therapy and supportive therapy.
16295776|NCT00675116|Drug|GW823296|
16295777|NCT00675103|Drug|pegloticase 8 mg i.v.|pegloticase 8 mg i.v. every 2 weeks for 24 weeks
16295778|NCT00675090|Drug|GSK239512|GSK239512 oral tablets once a day
16295779|NCT00675090|Drug|Placebo|Placebo tablets to match once a day
16295783|NCT00675038|Procedure|Liver Biopsy and MRI T2* MRI|Evaluation of iron overload with liver biopsy vs. MRI T2* MRI
16295784|NCT00675025|Drug|Donepezil hydrochloride (Aricept)|Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
16295785|NCT00675012|Drug|NGR-hTNF|iv 0.8 or 45 mcg/sqm q3W
16295786|NCT00675012|Drug|Oxaliplatin|iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
16295787|NCT00675012|Drug|capecitabine|orally 825 mg/sqm 2qDx14
16295788|NCT00674999|Biological|Amnion|Application of Amnion with processing procedures involving the use of trypsin-EDTA
16295789|NCT00674999|Biological|Amnion|Application of Amnion with processing procedures involving the use of Dispase II
16295790|NCT00674999|Drug|Polysporin/Bacitracin/Mycostatin|Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined
16295791|NCT00674986|Device|Accu-Chek 360° View Blood Glucose Analysis Tool|
16295792|NCT00674986|Device|Accu-Chek Aviva Glucose Meter|
16295793|NCT00674973|Drug|Erlotinib|Participants received erlotinib 150 mg tablet orally once daily.
16295794|NCT00674973|Drug|Placebo|Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
16295795|NCT00674960|Radiation|Radiation: Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
16295796|NCT00674947|Drug|BIIB015|IV infusion once every 3 weeks until disease progression or unacceptable toxicity
16295797|NCT00674934|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
16295798|NCT00674921|Drug|cotrimoxazole|cotrimoxazole 800/160 mg once daily as indicated by the start and end times of the specified arms for continued prevention of HIV-related infections
16295799|NCT00674921|Drug|Placebo|starch, magnesium stearate, sodium lauryl sulphate
16295800|NCT00674908|Biological|Shan 5|Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
16295801|NCT00674908|Biological|Easy Five|Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
16295802|NCT00674895|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Radiation: Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
16295804|NCT00674869|Other|pit and fissure sealant|pit and fissure sealant on one randomized tooth by pair of permanent molar
16295805|NCT00674856|Drug|naproxcinod|750mg
16295806|NCT00674843|Radiation|Far Infrared Radiation|Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared radiation for 30 to 40 minutes per treatment session.
16295807|NCT00674830|Behavioral|professionally administered cognitive-behavioral therapy|professionally administered CBT-I consisting of six weekly sessions
16295808|NCT00674830|Behavioral|self-administered form of cognitive-behavioral therapy|self-administered CBT-I consisting of six short booklets and videotapes
16295809|NCT00674830|Behavioral|placebo|usual care
16295812|NCT00674791|Biological|OCPM Immunotherapeutic Vaccine|Patients will receive 1 injection into each thigh at each of 6 visits: week 0, week 1, week 2, week 4, week 5, and week 6. The first 9 patients will receive a 100 microgram dose and the second 9 patients a 1 milligram dose of the peptide mixture.
16295813|NCT00674778|Procedure|Any percutaneous cardiovascular procedure|
16295814|NCT00674765|Drug|Seroquel|400 mg/day
16295815|NCT00674765|Drug|Placebo|400 mg/day
16295816|NCT00674752|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
16295817|NCT00674752|Drug|Gabapentin|Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
16295818|NCT00674752|Drug|Placebo|Matched placebo oral capsule 30 minutes prior to bedtime
16295819|NCT00674739|Drug|Imiquimod|daily topical application for up to 8 weeks
16295820|NCT00674739|Drug|3.75% imiquimod cream|3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
16295821|NCT00674739|Drug|placebo cream|placebo cream applied daily to wart areas for up to 8 weeks
16295822|NCT00674726|Other|Observation and measurement of axilo-rectal temperature|Measurement of axilo-rectal temperature
16295823|NCT00674713|Other|Acupuncture|
16295824|NCT00674713|Drug|Ondansetron|
16295825|NCT00674713|Drug|Physiological saline solution|
16295826|NCT00674713|Other|Sham acupuncture|
16295827|NCT00674713|Drug|Ondansetron|
16295828|NCT00674713|Other|Acupuncture at P6 point|
16295829|NCT00674713|Drug|Physiological saline solution|
16295830|NCT00674713|Other|Sham acupuncture|
16295831|NCT00674700|Drug|300 IR house dust mites allergen extract tablet|One sublingual tablet daily for one year
16295832|NCT00674700|Drug|500 IR house dust mites allergen extract tablet|One sublingual tablet daily for one year
16295833|NCT00674700|Drug|Placebo tablet|One sublingual tablet daily for one year
16295834|NCT00674687|Drug|2-weeks placebo then gabapentin|Placebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week
16295835|NCT00674687|Drug|1-week placebo then gabapentin|Placebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks
16295836|NCT00674674|Drug|Topotecan|"Induction (4 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 3.
~The Induction period is the first 4 weeks of therapy."
16295837|NCT00674674|Drug|Topotecan|Consolidation (6 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 4. The Consolidation period is 6 weeks in duration. Consolidation begins immediately after completion of the 4th week of Induction.
16295838|NCT00674674|Drug|Topotecan|Maintenance (4 weeks for 11 courses): Patients will receive IT topotecan for 5 consecutive days during week 1. Each course of Maintenance is 4 weeks in duration. Maintenance begins immediately after completion of the 6th week of Consolidation.
16295839|NCT00674661|Drug|riboflavin ophthalmic solution|riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
16295840|NCT00674661|Device|UVA Irradiation|UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
16295841|NCT00674648|Biological|CMV-Peptide-Specific T cells|"In this phase I trial, five escalating dose levels will be tested. Each dose will be administered to groups of at least 3 and up to 6 patients. Dose escalation will be based on the dose limiting toxicity (DLT) observed in each treatment group (Confer Biostatistics).
~The patient groups and donors are outlined as follows: Group I will receive a single dose of 5 x 105 T cells/kg body weight/dose; Group II will receive a single dose of 1 x 106 T cells/kg/dose; and group III will receive a single dose of 2 x 106 T cells/kg/dose; group IV will receive 3 weekly doses of 1 x 106 T cells/kg/dose; group V will receive 3 weekly doses of 2 x 106 T cells/kg/dose."
16295842|NCT00674635|Drug|GSK3152314A|Part A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose
16295843|NCT00674635|Drug|Placebo|matching placebo
16295844|NCT00674622|Drug|Prolotherapy|Injection of 15% dextrose with lidocaine at the lateral epicondyle
16295845|NCT00674622|Procedure|Placebo|Saline/lidocaine
16295846|NCT00674609|Drug|Placebo|Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
16295847|NCT00674609|Drug|Sativex®|Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
16295848|NCT00674609|Drug|THC Alone|Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
16295849|NCT00674596|Drug|ramipril|ramipril 10 mg/day during 3 months
16295850|NCT00674583|Biological|GSK Biologicals' meningococcal vaccine GSK134612|Intramuscular administration, 1 dose
16295851|NCT00674583|Biological|Menjugate|Intramuscular administration, 1 dose
16295852|NCT00674570|Drug|Hydrocortisone|25 mg/oral one hour prior to extinction task
16295853|NCT00674570|Drug|D-Cycloserine|50 mg/oral one hour prior to extinction task
16295854|NCT00674570|Drug|Placebo|One hour prior to extinction task
16295855|NCT00674557|Drug|SOD1 inhibitor ATN-224|
16295856|NCT00674557|Drug|exemestane|
16295857|NCT00674557|Genetic|protein expression analysis|
16295858|NCT00674557|Genetic|proteomic profiling|
16295859|NCT00674557|Other|laboratory biomarker analysis|
16295860|NCT00674557|Other|pharmacological study|
16295861|NCT00674544|Behavioral|Lifestyle intervention|Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings
16295862|NCT00674531|Procedure|Artery resection|Artery resection
16295863|NCT00674518|Behavioral|One on one counseling|Motivational Interviewing
16295864|NCT00674518|Behavioral|Group/team - based health education|peer led, scripted health promotion curriculum in groups of 4-5 individual, with team building activities and health education for 12, 1-hour sessions per year.
16295865|NCT00674518|Behavioral|PACE physician counseling|PACE format for physician exercise and nutrition counseling annually.
16295866|NCT00674505|Device|Lumen Biomedical FiberNet Embolic Protection System|to demonstrate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System during the performance of primary renal stenting in the treatment of pts with a high grade ostial atherosclerotic renal lesion(s).
16295867|NCT00674479|Drug|INCB018424|Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.
16295868|NCT00674466|Drug|1.5 mg or 2.0 mg CJC-1134-PC|twice-a-week
16295869|NCT00674466|Drug|Placebo|twice-a-week
16295870|NCT00674453|Drug|Lasofoxifene|Oral tablet, 0.25 mg, daily, 2 years
16295871|NCT00674453|Other|Placebo|Matching placebo tablet given once daily for 2 years
16295872|NCT00674440|Drug|F-DOPA|0.08-0.16 mCi/kg once
16295873|NCT00674440|Radiation|PET scan|
16295874|NCT00674427|Biological|CD3/CD28 Activated T cells|Subjects who are not in CR will receive one infusion of high dose aDLI
16295875|NCT00674427|Biological|CD3/CD28 Activated T cells|Subjects in CR 6-12 weeks after the first dose of Activated Donor Lymphocyte Infusion (aDLI) will continue to receive aDLI every 3 months for up to a year.
16295876|NCT00674414|Biological|trastuzumab|Trastuzumab (Herceptin®) IV once weekly
16295877|NCT00674414|Drug|everolimus|Oral everolimus once daily
16295878|NCT00674414|Procedure|therapeutic conventional surgery|Patients undergo surgery
16295879|NCT00674401|Procedure|Radiofrequency catheter ablation|"In case of Paroxysmal AF, patients will be randomized into one of 2 in the study:
~Empirical pulmonary vein antrum circumferential isolation, or
~High frequency sites ablation in the LA
~In case of Persistent AF, patients will be randomized into one of 2 in the study:
~Empirical circumferential PV antrum isolation w/out roof line, or
~A combined approach involving PV antrum isolation w/out roof line and high frequency sites ablation."
16295880|NCT00674375|Other|Electronic risk alerts|Electronic risk alerts within the electronic medical record system will automatically calculate a patient's Framingham Risk Score during office visits for chest pain. These alerts will recommend electrocardiogram performance and aspirin therapy for patients with Framingham Risk Score at least 10%, and will recommend against exercise stress testing for patients with a Framingham Risk Score less than 10%.
16295881|NCT00674362|Biological|Certolizumab pegol|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
16295882|NCT00674362|Biological|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
16295883|NCT00674349|Procedure|surgery|staging surgery
16295884|NCT00674336|Procedure|High Hydrostatic Pressure Processing|High Hydrostatic Pressure Processing is a technology, used in the food service industry, where foods are subjected to high pressure. These high pressures kill many pathogens without affecting the quality of the food.
16295885|NCT00674323|Drug|Verteporfin Photodynamic Therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, light application of 50 J/cm^2 to the study eye was begun 15 minutes after the start of infusion.
16295886|NCT00674323|Drug|Ranibizumab|Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.
16295887|NCT00674310|Drug|Ropinirole Hydrochloride|Restless Leg Syndrome
16295888|NCT00674297|Drug|Fluvastatin|Fluvastatin 40 mg daily for 3 months
16295889|NCT00674258|Biological|URLC10, TTK and KOC1|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), TTK- peptide(1mg) and KOC1- peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16295890|NCT00674245|Drug|Pantoprazole|40 mg once daily for 4 weeks
16295891|NCT00674245|Drug|Pantoprazole|40 mg once daily improves sleep quality in patients with GERD.
16295892|NCT00674245|Drug|placebo|40 mg once daily for 4 weeks
16295893|NCT00674232|Drug|600 mcg misoprostol|single dose of misoprostol taken orally
16295894|NCT00674232|Procedure|Surgical treatment|Either dilation and curettage or manual vacuum aspiration, as per local protocol
16295895|NCT00674219|Drug|Memantine|Namenda 10mg BID for 12 weeks
16295896|NCT00674206|Drug|Gemcitabine|Gemcitabine 1000mg/m^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
16295897|NCT00674206|Drug|Oxaliplatin|Oxaliplatin 100mg/m^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
16295898|NCT00674193|Other|pharmacological study|Correlative studies
16295899|NCT00674193|Other|laboratory biomarker analysis|Correlative studies
16295900|NCT00674180|Behavioral|Workbook|The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs.
16295901|NCT00674180|Behavioral|Computer Intervention|The computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content.
16295902|NCT00674180|Behavioral|Staff Consultation|The staff consultation component included 6 closed-group workshop sessions and up to 18 telephone or face-to-face consultations with a registered dietician and/or a cognitive behavioral therapist. The workshop curriculum focused on specific activities and assignments in the workbook, and it encouraged use of the computer to identify problems and issues.
16295903|NCT00674167|Drug|Docetaxel|Three cycles of chemotherapy will be administered before surgery with docetaxel at 30 mg/m² on day 1 and 8 in a 21 day treatment cycles.
16295904|NCT00674167|Drug|Cisplatin|Three cycles of chemotherapy will be administered before surgery with cisplatin at 30 mg/m² on day 1 and 8 in a 21 day treatment cycle.
16295905|NCT00674167|Drug|Capecitabine|Three cycles of chemotherapy will be administered before surgery with capecitabine at 750 mg/m² twice daily from day 1 to 14 in a 21 day treatment cycle.
16295906|NCT00674154|Drug|Cholecalciferol|2800 IE daily in 52 weeks
16295907|NCT00674141|Drug|Dexamethasone soduim phosphate|nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment
16295908|NCT00674128|Device|Cyanoacrylate tissue adhesive (Dermabond)|Skin closure will be performed with cyanoacrylate tissue adhesive.
16295909|NCT00674128|Device|Polyglactin 910 suture (Vicryl)|Skin closure will be performed with polyglactin 910 suture.
16295910|NCT00674115|Drug|Omeprazole/sodium bicarbonate|Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
16295911|NCT00674115|Drug|omeprazole magnesium|Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
16295912|NCT00674115|Drug|sodium bicarbonate|Sodium bicarbonate. Single dose.
16295913|NCT00674102|Drug|ASA404|
16295914|NCT00674089|Dietary Supplement|Vitamin A|Vitamin A 50,000 IU
16295915|NCT00674089|Dietary Supplement|Placebo|Vitamin A Placebo
16295916|NCT00674063|Drug|alefacept|IV
16295917|NCT00674050|Drug|Technosphere Insulin (TI) Inhalation Powder|3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.
16295918|NCT00674050|Drug|Albuterol (Salbutamol)|2 puff= 200ug total dose
16295919|NCT00674050|Drug|Fluticasone|2 puffs= 500ug total dose
16295920|NCT00674037|Other|monetary incentive|75 euros for each patient included
16295921|NCT00674024|Drug|Pazopanib|
16295922|NCT00674024|Drug|Pazopanib (GW786034)(GW786034)|
16295923|NCT00674011|Drug|Bevacizumab|Given as part of standard of care or another research protocol
16295924|NCT00673998|Device|Isokinetic Dynamometer (Biodex system III)|Biodex system III Isokinetic Dynamometer (Biodex Medical, Inc., Shirley, NY).
16295925|NCT00673985|Other|Percutaneous Transluminal Angioplasty|Balloon Angioplasty
16295926|NCT00673985|Device|LifeStent NT™ Self-Expanding Peripheral Stent|Balloon angioplasty plus stent
16295927|NCT00673972|Radiation|gastric scintigraphy|"All tests start after overnight fast. Test meals consists of 120g scrambled egg, two slices of toasted bread, 30g of strawberry jam and 120ml of water. 12MBg (0.33mCi) of 99mTc sulfur colloid is mixed with egg thoroughly before the mixture cooked in a microwave oven for 2 minutes. All meals are prepared on the morning of examination and consumed within 20 minutes.
~Anterior and posterior images of the gastric region are taken within one minute after completion of test meals. Subsequent images are taken every 2 minutes in the first 60 minutes and at 120 minutes and 180 minutes. One-min images of gastric region at upright position are taken in the 140keV 99mTc peak with a 20% window."
16295928|NCT00673959|Other|Lubricant Eye Drop FID 111421|Lubricant Eye Drop FID 111421 1 drop each eye one time
16295929|NCT00673959|Other|Optive Lubricant Eye Drop|Optive Lubricant Eye Drop 1 drop each eye one time
16295930|NCT00673946|Other|True saturation values displayed|Physicians will be presented with real saturations.
16295931|NCT00673946|Other|Altered saturation values displayed.|Physicians will be presented with saturation measurements three percentage points above the true values.
16295932|NCT00673933|Drug|Methyl aminolevulinate (MAL) PDT|Cream application followed by illumination with red light
16295933|NCT00673920|Drug|Methotrexate|Oral or parenteral repeating dose
16295934|NCT00673920|Drug|Ocrelizumab|"Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).
~Ocrelizumab was administered in combination with Methotrexate."
16295935|NCT00673920|Drug|Placebo|Intravenous repeating dose
16295936|NCT00673907|Other|Wood smoke particles|Subjects are exposed at rest to the exposures for 3 h in our climate chamber
16295937|NCT00673894|Drug|Sitagliptin|Glutamine 30g +sitagliptin 100mg
16295938|NCT00673894|Drug|Placebo|Glutamine 30g +placebo (matching sitagliptin 100 mg)
16295939|NCT00673881|Drug|choline fenofibrate|135 mg choline fenofibrate daily(oral, capsule)
16295940|NCT00673868|Biological|CMV Specific Cytotoxic T Lymphocytes|CMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg.
16295941|NCT00673855|Other|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903 1 drop each eye 1 time
16295942|NCT00673855|Other|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
16295943|NCT00673842|Device|Implantable Cardioverter Defibrillator + Usual Care|Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
16295944|NCT00673842|Other|Usual care|Usual post-MI care
16295945|NCT00673829|Biological|Gene Modified T Cells|Gene Modified T Cells Phase Ia: One time infusion Modified TCells given through a vein in the arm or a catheter over a 30-60 minute period
16295946|NCT00673829|Biological|Gene Modified T Cells and Interleukin 2|One time infusion Modified T Cells without or with (randomized) continuous infusion outpatient interleukin 2 (IL2) for two weeks
16295947|NCT00673816|Drug|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
16295948|NCT00673803|Procedure|cataract surgery|cataract surgery with implantation of an IOL
16295949|NCT00673790|Drug|Nebivolol with concomitant losartan or lisinopril|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
16295950|NCT00673790|Drug|HCTZ with concomitant losartan or lisinopril|Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
16295951|NCT00673790|Drug|Placebo with concomitant losartan or lisinopril|Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
16295952|NCT00673777|Biological|URLC10, VEGFR1 and VEGFR2|Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16295953|NCT00673764|Other|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops 1 drop each eye one time
16295954|NCT00673764|Other|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops 1 drop each eye one time
16295955|NCT00673751|Drug|GLP-2|450 nmol subcutaneous
16295956|NCT00673751|Drug|Placebo|
16295957|NCT00673738|Drug|Cetuximab|"Cetuximab dose: based on patient's actual weight. Loading phase dose of cetuximab is 400 mg/m2 IV administered over 120 minutes, on day 1 followed by; Concurrent phase, weekly infusion dose at 250 mg/m2 IV over 60 minutes, on days 8, 15, 22, 29, 36, 43, 50.
~Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week complete blood counts (CBCs), differentials, and blood urea nitrogen (BUN) plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted."
16295958|NCT00673738|Radiation|Conformal Thoracic Radiotherapy (CTRT)|"Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week CBCs, differentials, and BUN plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted.
~Radiation therapy will begin on day 8 (with window of ± 3 days). Adequate hematologic profile (ANC >1,000 and platelets >75,000) required. Patient may be delayed for a max. of 2 weeks. If > 2 week delay occurs, patient will come off study."
16295959|NCT00673725|Drug|Locobase® REPAIR|emollient
16295960|NCT00673712|Device|Continuous Sternal Block|Elastomeric Pump for Continuous Infusion of Local Anesthetic
16295961|NCT00673712|Drug|Opioid based analgesia|"Opioid Analgesic agents delivered by:
~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
16295962|NCT00673699|Procedure|Gastric mucosal biopsy|Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia
16295963|NCT00673686|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
16295964|NCT00673686|Drug|Yasminelle (SH T 00186 D)|SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
16295965|NCT00673673|Drug|FOLFOX|Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
16295966|NCT00673673|Drug|bevacizumab|bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
16295967|NCT00673660|Behavioral|Patient Compliance|Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.
16295968|NCT00673647|Behavioral|Cognitive-behavioral treatment|10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.
16295969|NCT00673634|Procedure|Standard preoxygenation|Spontaneous breathing of 100% oxygen in a facemask for 3 minutes.
16295970|NCT00673634|Procedure|BiPAP assisted preoxygenation|Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4cm H2O and a positive end-expiratory pressure of 4cm H2O, for 3 minutes.
16295971|NCT00673621|Drug|Technosphere Insulin Inhalation Powder|3.0 of human insulin. single dose cartridges filled with 5 or 10 mg of Technosphere Inhalation Powder, containing 15 or 30 u of insulin
16295972|NCT00673621|Drug|Salbutamol (Albuterol)|2 puff = 200 mcg total dose
16295973|NCT00673621|Drug|Methacholine chloride|5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%
16295974|NCT00673608|Drug|deferasirox|Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily
16295975|NCT00673595|Drug|Varenicline|"Smoking cessation assistance: study days 1-3: 0.5 mg once daily, study days 4-7: 0.5 mg twice daily, study days 8-15: 1 mg twice daily; study day 16: 1 mg once. The tablets should be taken orally after food intake with 200 ml of water.
~The treatment phase may be prolonged up to a maximum of 2 weeks under the following conditions: 1) the participant voluntarily agrees to the prolongation of the study, 2) both the participant and investigator are confident that the participant will be able to completely refrain from smoking for at least 10 days until the final study day."
16295976|NCT00673595|Drug|Placebo|The pharmacy will prepare tablets that match the varenicline tablets. The tablets should be taken orally after food intake with 200 ml of water.
16295977|NCT00673582|Drug|Rosuvastatin|10 mg/day rosuvastatin
16295978|NCT00673582|Drug|Placebo|Placebo, 10 mg a day for 96 weeks
16295979|NCT00673569|Drug|erlotinib hydrochloride|
16295980|NCT00673569|Genetic|gene expression analysis|
16295981|NCT00673569|Genetic|protein expression analysis|
16295982|NCT00673569|Other|immunoenzyme technique|
16295983|NCT00673569|Other|immunologic technique|
16295984|NCT00673569|Other|laboratory biomarker analysis|
16295985|NCT00673569|Procedure|needle biopsy|
16295986|NCT00673556|Drug|alefacept|Intramuscular (IM)
16295987|NCT00673556|Drug|placebo|Intramuscular (IM)
16295988|NCT00673530|Behavioral|evidence based clinical nutrition concept|The evidence based nutrition concept comprise a routine malnutrition screening for hospitalized patients, the implementation of an evidence based guideline for clinical nutrition in the participating hospital, education training of the clinical staff and thereby optimal clinical nutrition for malnourished hospitalized patients.
16295989|NCT00673530|Behavioral|care as usual|Unchanged treatment of hospital patients without interference by the study.
16295990|NCT00673504|Drug|Gemcitabine + Sunitinib|Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
16295991|NCT00673504|Drug|Gemcitabine|1.000 mg/m2 d1,8,15q4weeks
16295992|NCT00673491|Other|Clinical Pathways|Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period. Defining characteristics of clinical pathways includes: an explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of the communication, coordination of roles, and sequencing the activities of the multidisciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of the appropriate resources.
16295993|NCT00673478|Drug|Tiotropium+Salmeterol|
16295994|NCT00673478|Drug|Salmeterol|
16295995|NCT00673478|Drug|Tiotropium|
16295996|NCT00673465|Drug|SCH 497079|SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks
16295997|NCT00673465|Drug|Placebo|Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks
16295998|NCT00673465|Drug|Metformin|Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)
16295999|NCT00673452|Drug|duloxetine hydrochloride|60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
16296000|NCT00673452|Drug|placebo|oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
16296001|NCT00673439|Drug|fondaparinux|Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2
16296002|NCT00673439|Drug|warfarin|Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks
16296003|NCT00673426|Biological|Enoxaparin sodic|
16296004|NCT00673400|Procedure|Stapled transanal rectum resection|Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception. The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum. This cut opens the prolapse. Check with a finger the vagina. The device is then closed and fired. After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the staple line to assure haemostasis.
16296005|NCT00673387|Drug|pramlintide acetate|subcutaneous injection, twice a day
16296006|NCT00673387|Drug|metreleptin|subcutaneous injection, twice a day
16296007|NCT00673387|Drug|placebo-P|subcutaneous injection, twice a day
16296008|NCT00673387|Drug|placebo-M|subcutaneous injection, twice a day
16296009|NCT00673374|Device|radio-opaque adhesive skin markers|The examining physician will place a radio-opaque skin marker (Beekley Corporation, Ortho-SPOTS® Order Code 187; 6mm spherical markers) at the point of maximal tenderness to direct abdominal palpation indicated by the patient. Additional markers will be placed at the cephalad and caudad limits of the region of tenderness, defined as the point at which the patient no longer complains of direct tenderness to palpation.
16296057|NCT00673166|Procedure|Staff incentive & supervision|Control & management of funds for incentive of staff; supervision
16296058|NCT00673166|Behavioral|Staff motivation|Supervision, control of funds
16296059|NCT00673153|Drug|gemtuzumab ozogamicin|Given IV
16296010|NCT00673361|Drug|Concurrent decrescendo biochemotherapy regimen|"Temozolomide: 200mg/m^2, daily, PO, days 1-4
~Vinblastine: 1.5mg/m^2, daily, IV, days 1-4
~Cisplatin: 20mg/m^2, daily IV, days 1-4
~IL (interleukin)-2: - 18 milli-International unit (MIU)/m^2, IVCI (intravenous continual infusion), day 1
~9 MIU/m^2, IVCI, day 2
~4.5 MIU/m^2, IVCI, days 3 & 4
~Interferon (IFN) alpha: 5 MIU/m^2, daily, SC (subcutaneously), days 1-5
~5-day inpatient regimen, to be repeated every 21 days"
16296011|NCT00673361|Drug|Low-dose Temozolomide plus Sorafenib|Temozolomide: 75mg/m^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks
16296012|NCT00673335|Drug|letrozole|
16296013|NCT00673335|Drug|Placebo|
16296014|NCT00673322|Biological|Gene Modified T Cells|One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
16296015|NCT00673309|Procedure|Stable Isotope Infusion study|Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
16296016|NCT00673309|Drug|Insulin High Dose|Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
16296017|NCT00673309|Drug|oxandrolone|Oxandrolone given daily throughout hospitalization until 95% wound healing.
16296018|NCT00673309|Drug|Propranolol|Propranolol to be given daily throughout hospitalization until 95% wound healing.
16296019|NCT00673309|Drug|Growth Hormone|Recombinant Human Growth hormone to be administered daily until 95% wound healing.
16296020|NCT00673309|Drug|Insulin Low Dose|Insulin administered IV until 95% wound healing
16296021|NCT00673309|Drug|IGF-1/IGFBP-3|Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
16296022|NCT00673309|Drug|Itraconazole|Itraconazole administered until 95% wound healing
16296023|NCT00673309|Drug|Growth Hormone and Propranolol|Growth Hormone and Propranolol given until 95% wound healing
16296024|NCT00673309|Drug|Oxandrolone and Propranolol|Oxandrolone and Propranolol
16296025|NCT00673309|Drug|Placebo or Control|Administration of Placebo or Control until 95% wound healing
16296026|NCT00673296|Drug|Intravitreal Bevacizumab|Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)
16296027|NCT00673283|Device|bi-plane chest radiography|Bi-plane radiography of the thorax
16296028|NCT00673270|Drug|Fludrocortisone|50 µg of fludrocortisone per os
16296029|NCT00673270|Drug|Hydrocortisone|50 mg of intravenous hydrocortisone
16296030|NCT00673270|Drug|Placebo of Fludrocortisone|Tablet of placebo of Fludrocortisone
16296031|NCT00673270|Drug|Placebo of Hydrocortisone|2 ml of isotonic saline solution
16296032|NCT00673257|Other|pharmacological study|pharmacological studies
16296033|NCT00673257|Procedure|dual x-ray absorptimetry|
16296034|NCT00673244|Drug|Furosemide|One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.
16296035|NCT00673231|Drug|Dapagliflozin|tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
16296036|NCT00673231|Drug|Dapagliflozin|Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
16296037|NCT00673231|Drug|Dapagliflozin|Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
16296038|NCT00673231|Drug|Placebo|Placebo
16296039|NCT00673231|Drug|Dapagliflozin|tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
16296040|NCT00673231|Drug|Dapagliflozin|tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
16296041|NCT00673218|Drug|Placebo|Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
16296042|NCT00673218|Drug|Xolair|150 to 375 mg is administered SC every 2 or 4 weeks
16296043|NCT00673205|Drug|Bicalutamide|150mg p.o. daily
16296044|NCT00673205|Drug|Placebo|
16296045|NCT00673192|Procedure|peripheral blood isolation|to isolate serum from patient peripheral blood to test the titer of HPV infection and cytokine expression
16296046|NCT00673179|Drug|Doxorubicin|Pre-Surgery, Regimen 1: IV Over 15 Minutes on Day 1 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV on Day 1 of Weeks 16, 21, and 26; Pre-Surgery, Regimen 2: IV over 15 Minutes on Day 1 of Weeks 1, 4, and 7. Dose 90 mg/m^2.
16296047|NCT00673179|Drug|Cisplatin|Pre-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 16, 21, and 26. Pre-Surgery, Regimen 2: Infusion through an artery over 4 hours on Day 1 of Weeks 1, 4, and 7. Dose 60 mg/m^2/day for 2 days continuous infusion.
16296048|NCT00673179|Drug|Methotrexate|Pre-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 4, 5, 9, and 10; Post-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 14, 15, 19, 20, 24, 25, 29, and 30; Post-Surgery, Regimen 2: IV Over 4 Hours on Day 1 of Weeks 14, 15, 20, 21, 26, 27, 32, 33, 38, and 39. Dose 12 gm/m^2, max 20 gm over 4 hours.
16296049|NCT00673179|Drug|Leucovorin|Pre- and Post-Surgery, Regimen 1: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours; Post-Surgery, Regimen 2: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours. Dose 10 mg IV, with 10 mg orally every 6 hours.
16296050|NCT00673179|Drug|Dexrazoxane|Dose 900 mg/m^2 IV Push with doxorubicin. Pre-Surgery, Regimen 2: IV Over 15 minutes on Day 1 of Weeks 1, 4, and 7.
16296051|NCT00673179|Drug|Ifosfamide|Post-Surgery, Regimen 2: IV continuously over 5 days each time, on Weeks 16, 22, 28, and 34. Dose 2.8 gm/m^2. Dose 2.8 grams m^2/day.
16296052|NCT00673179|Behavioral|Questionnaire|Questionnaires to be completed on 5 different days during the study.
16296053|NCT00673179|Drug|Gemcitabine|IV over 1 hour, every other week.
16296054|NCT00673179|Drug|Sargramostim|Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg) twice a day for 7 days on, 7 days off, beginning the day receive gemcitabine.
16296055|NCT00673179|Procedure|Surgery|Planned limb salvage surgery after 3 courses of doxorubicin + cisplatin (IV) and High-dose methotrexate - at approximately week 12.
16296056|NCT00673179|Drug|Mesna|IV continuously over 6 days each time, on Weeks 16, 22, 28, and 34. Dose 2.8 gm/m^2/day.
16296060|NCT00673153|Drug|vorinostat|Given orally
16296061|NCT00673153|Other|laboratory biomarker analysis|Correlative studies
16296062|NCT00673140|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Radiation: Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
16296063|NCT00673140|Radiation|Far infrared radiation|Far infrared radiation at a frequency of 5 microns to 20 microns for 30 to 40 minutes per session.
16296064|NCT00673127|Drug|Ketoconazole, Hydrocortisone and Dutasteride|"Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.
~Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal"
16296065|NCT00673114|Biological|haplo/cord transplant|T-cell depleted haplo-matched cells from related donor and unrelated umbilical cord blood
16296066|NCT00673088|Drug|Ropinirole Hydrochloride|Restless Leg Syndrome
16296067|NCT00673075|Drug|Nebivolol|Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
16296068|NCT00673075|Drug|Carvedilol|Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
16296069|NCT00673062|Drug|SCH 900538|(4X50mg Capsules)
16296070|NCT00673062|Drug|Pseudoephedrine|Encapsulated pseudoephedrine (2X30 mg immediate release tablets)
16296071|NCT00673062|Drug|Placebo Capsules|Placebo
16296072|NCT00673049|Drug|CP 751,871 (Figitumumab)|CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
16296073|NCT00673049|Drug|Erlotinib|Erlotinib (one tablet of 150 mg/day PO).
16296074|NCT00673049|Drug|Erlotinib|Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.
16296075|NCT00673036|Other|Blood sample|60 ml of whole blood
16296076|NCT00673023|Other|Dietary experiments|Dietary Supplement: high PUFA diet followed by high SFA diet
16296077|NCT00673010|Radiation|131 I-iodine (131-I), 124 I-iodine (124-I)|Those who have demonstrated metastases which concentrate radioiodine will undergo routine testing to determine the MTA for blood and lung tissue. This will be performed with 124-I instead of 131-I. If the diagnostic scans (done with 123-I) show that the metastatic lesions concentrate radioiodine, the patient will be treated with 131-I based on standard of care discussions at a tumor board meeting. One week following the 131-I therapy, a whole body scan will be obtained and compared with the 124-I diagnostic scan. One year later, another extent of disease workup will be performed which will include 124-I dosimetry and scanning.
16296078|NCT00672997|Drug|Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution|
16296079|NCT00672997|Drug|Travoprost 0.004%/Timolol 0.5% ophthalmic solution|
16296080|NCT00672984|Drug|immediate release guanfacine hydrochloride|Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
16296081|NCT00672984|Drug|moxifloxacin|Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
16296082|NCT00672984|Drug|Placebo|Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
16296083|NCT00672971|Other|4% dimethicone foam|The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days.
16296084|NCT00672971|Other|1% permethrin|Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days.
16296085|NCT00672958|Drug|Vortioxetine|Encapsulated immediate-release tablets.
16296086|NCT00672958|Drug|Placebo|Vortioxetine placebo-matching capsules.
16296087|NCT00672945|Drug|PRX-03140|
16296088|NCT00672945|Drug|Placebo|
16296089|NCT00672932|Drug|raltegravir|400 mg two times daily for three months
16296090|NCT00672919|Drug|Pioglitazone|Pioglitazone 30 mg to 45 mg, tablets, orally, once daily in combination with stable statin therapy for up to 17 weeks.
16296091|NCT00672906|Behavioral|Group Parent Training|Skills group for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
16296092|NCT00672906|Behavioral|Maudsley Family Therapy|Family therapy specifically adapted for the treatment of adolescent anorexia nervosa.
16296093|NCT00672893|Other|Vibration Response Imaging|12 seconds of recording lung sounds
16296094|NCT00672880|Behavioral|Self-System Therapy|12 sessions of structured Self-System Therapy
16296095|NCT00672880|Behavioral|Education|12 sessions of spine and muscle education including life style changes and medical treatments.
16296096|NCT00672880|Other|Standard Care|Study participants continue with their usual medical care, no changes.
16296097|NCT00672867|Drug|Clevudine|30mg
16296098|NCT00672867|Drug|Adefovir dipivoxil|10mg
16296099|NCT00672854|Drug|ClinOleic 20% Intravenous Emulsion|ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake.
16296100|NCT00672854|Drug|Intralipid, 20% Intravenous Emulsion|It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection
16296101|NCT00672841|Drug|Preemptive Therapy with Anidulafungin|Subjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days.
16296102|NCT00672841|Drug|Empiric antifungal therapy based on physician discretion.|Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.
16296103|NCT00672828|Behavioral|Non-tailored CRC screening brochure|Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
16296104|NCT00672828|Behavioral|Interactive computer intervention|
16296148|NCT00672464|Drug|Olanzapine|Olanzapine zydis 15 mg QHS for 28 days
16296105|NCT00672802|Drug|Ramelteon and Placebo|Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.
16296106|NCT00672789|Behavioral|Blood smear education|education at baseline and three month follow-up
16296107|NCT00672789|Other|standard education|standard education
16296108|NCT00672776|Drug|paroxetine|
16296109|NCT00672776|Drug|placebo|
16296110|NCT00672763|Drug|Colecalciferol D3 (Vigantol Oil)|"Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks;
~Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment;
~Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses)."
16296111|NCT00672763|Drug|Medium chain triglycerides|"Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks;
~Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment;
~Migliol Oil 5ml oral fortnightly (2 doses)"
16296112|NCT00672737|Drug|Remifentanil|Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order.
16296113|NCT00672737|Procedure|Cold pain threshold and tolerance|Ice water was used to assess cold-related pain threshold and tolerance, defined as the time that the volunteers could keep their hands in the water before they started feeling pain or this feeling becomes unbearable, for threshold and tolerance, respectively.
16296114|NCT00672737|Device|Heat pain threshold and tolerance|TSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), was used to assess the heat-related pain and tolerance of the volunteers defined as the respective temperatures where they started feeling as painful or unbearable.
16296115|NCT00672737|Procedure|Polysomnography|All volunteers underwent a polysomnography study at home or at Stanford Sleep Center, approximately one week before their experimental pain assessment in the laboratory
16296116|NCT00672724|Drug|Ramelteon|Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.
16296117|NCT00672724|Drug|Placebo|Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.
16296118|NCT00672698|Procedure|SURGERY|ELECTIVE SURGICAL PROCEDURES
16296119|NCT00672685|Dietary Supplement|omega-3|V0137 CA containing 400 mg docosahexaenoic acid (DHA) - 2 soft capsules once a day, i.e. 800 mg DHA per day for 36 months
16296120|NCT00672685|Behavioral|multi-domain intervention|multi-domain intervention = Nutrition, physical exercise, cognitive training and social activities, and preventive consultations
16296121|NCT00672685|Drug|Placebo|OMEGA-3 placebo
16296122|NCT00672672|Biological|autologous platelet gel|Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.
16296123|NCT00672659|Drug|Citalopram + Pipamperone|Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
16296124|NCT00672659|Drug|Citalopram|Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks
16296125|NCT00672646|Drug|AZD1386|95mg, oral solution, single dose
16296126|NCT00672646|Drug|Naproxen|500mg, capsule, single dose
16296127|NCT00672646|Drug|Placebo|AZD1386 Placebo oral solution
16296128|NCT00672633|Drug|Lovaza|Lovaza , 4 grams/day orally for 6 months
16296129|NCT00672633|Drug|Placebo|Corn Oil Pill, 4 pills/day orally for 6 months
16296130|NCT00672620|Drug|Vortioxetine|Encapsulated vortioxetine immediate-release tablets
16296131|NCT00672620|Drug|Duloxetine|Duloxetine capsules
16296132|NCT00672620|Drug|Placebo|Placebo-matching capsules
16296133|NCT00672607|Drug|extracts of Vitex agnus castus tablets|orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
16296134|NCT00672607|Drug|Placebo|Placebo
16296135|NCT00672594|Drug|Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
16296136|NCT00672581|Drug|ZD4054|10mg, Oral tablet, single dose
16296137|NCT00672568|Drug|4975 - Highly purified capsaicin|Solution, 0.5 mg, single dose, injection
16296138|NCT00672568|Drug|4975 - Highly purified capsaicin|Solution, 0.75 mg, single dose, injection
16296139|NCT00672568|Drug|4975 - Highly purified capsaicin|Solution, 0.1 mg, Single dose, injection
16296140|NCT00672568|Drug|Placebo|Solution, single dose, injection
16296141|NCT00672555|Procedure|Limberg-flap|Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock
16296142|NCT00672542|Biological|Proteasome siRNA and tumor antigen RNA-transfected dendritic cells|The safety and toxicity of vaccination with tumor antigen RNA-transfected dendritic cells (DC), derived from either untransfected or siRNA-transfected monocytes, will be evaluated in subjects with metastatic melanoma. Subjects will undergo leukapheresis and monocytes will be isolated. These monocytes will then be left untreated (Study Arm A) or transfected with either control siRNA (Study Arm B) or siRNA targeting immunoproteasome subunits LMP2, LMP7, and MECL1 (Study Arm C), then differentiated into DC in vitro . After the induction of maturation, these DC will be transfected with RNA encoding defined melanoma antigens MART, MAGE-3, tyrosinase, and gp100. These RNA-transfected autologous DC will be cryopreserved, then used to vaccinate subjects with metastatic melanoma, each of whom will receive a total of six intradermal (ID) injections using 1x10e7 DC at each cycle, administered weekly.
16296143|NCT00672529|Dietary Supplement|Orthomolecular Therapy or Placebo Comparator|"The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercetin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product.
~Eligible patients will be randomized to an orthomolecular treatment regime or placebo with a 2:1 randomization ratio and will remain on their randomized treatment for 16 weeks. For the first 8 weeks of the intervention period inhaled corticosteroid treatment will be unchanged. In the remaining 8 weeks dose adjustment will occur every two weeks. Participants will be monitored closely for changes in their lung function."
16296144|NCT00672490|Drug|Quetiapine Fumarate|"Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.
~Tablets"
16296145|NCT00672490|Drug|Lithium|Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.
16296146|NCT00672477|Drug|Methylnaltrexone|
16296147|NCT00672477|Drug|Placebo|
16296149|NCT00672464|Drug|Metformin|Metformin capsules will be started at 500 mg twice a day (before breakfast and before dinner) for days 1-3, then 500 mg before breakfast and 1000 mg before dinner for days 4-7, and then 1000 mg twice a day thereafter.
16296150|NCT00672464|Drug|Simvastatin|Simvastatin will be started at 10 mg at bed time for the first week and 20 mg at bedtime thereafter.
16296151|NCT00672451|Dietary Supplement|rhubarb extract|titrate rhubarb extract titrated up to 6grams daily by mouth
16296152|NCT00672451|Dietary Supplement|placebo|placebo titrated up to 6 pills daily as patient tolerates
16296153|NCT00672438|Drug|Alfentanil|Target controlled intravenous infusion of alfentanil at a plasma concentration of 100ng/ml
16296154|NCT00672438|Other|Saline placebo infusion|Intravenous infusion of normal saline
16296155|NCT00672412|Drug|GPO-Vir Z30 tablet|Tablet consisting of ZDV 30 mg/3TC 15 mg/NVP 28 mg taken orally twice daily
16296156|NCT00672412|Drug|Lamivudine|Oral suspension containing 10 mg 3TC in each mL. Dosage depends on weight.
16296157|NCT00672412|Drug|Nevirapine|Oral solution containing 10 mg NVP in each mL. Dosage depends on weight.
16296158|NCT00672412|Drug|Zidovudine|Oral solution containing 10 mg ZDV in each mL. Dosage depends on weight.
16296159|NCT00672399|Drug|exenatide|Subcutaneously injected, 10 mcg, single doses
16296160|NCT00672399|Drug|Moxifloxacin|oral, 400 mg tablet, single doses
16296161|NCT00672399|Drug|Placebo|Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses
16296162|NCT00672386|Drug|JNJ16269110|5 mg twice daily for 12 weeks
16296163|NCT00672386|Drug|JNJ16269110|10 mg twice daily for 12 weeks
16296164|NCT00672386|Drug|JNJ16269110|15 mg twice daily for 12 weeks
16296165|NCT00672386|Drug|Placebo|twice daily for 12 weeks
16296166|NCT00672386|Drug|Metformin|Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
16296167|NCT00672386|Other|Dietary Counseling|Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
16296168|NCT00672373|Drug|Extract of Ginkgo Biloba (EGb-761 capsules)|EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.
16296169|NCT00672373|Drug|Placebo|Wheat flour placebo capsule,1 capsule tid, po,12 weeks
16296170|NCT00672360|Dietary Supplement|Folic acid|Compounded capsule, 7.6mg, taken orally, twice daily for 4 weeks.
16296171|NCT00672360|Dietary Supplement|Placebo|Compounded capsule of NaCl, taken orally, twice daily for 4 weeks.
16296172|NCT00672347|Drug|Clonidine|1 mcg/kg
16296173|NCT00672347|Drug|Morphine|20 mcg/kg
16296174|NCT00672347|Drug|Bupivacaine plus clonidine and morphine|"bupivacaine 0,166% 1 ml/kg
~clonidine 1 mcg/kg
~morphine 20 mcg/kg"
16296175|NCT00672347|Drug|Bupivacaine|Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
16296176|NCT00672334|Drug|Sodium Bicarbonate|In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium bicarbonate at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).
16296177|NCT00672334|Drug|Sodium Chloride|In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium chloride at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).
16296178|NCT00672321|Genetic|gene expression analysis|
16296179|NCT00672321|Genetic|mutation analysis|
16296180|NCT00672321|Genetic|polymorphism analysis|
16296181|NCT00672321|Other|laboratory biomarker analysis|
16296182|NCT00672321|Other|questionnaire administration|
16296183|NCT00672308|Other|Benefiber|
16296184|NCT00672308|Other|Benefiber with ORS|Benefiber (50 g/L)-supplemented, reduced-osmolarity WHO-ORS
16296185|NCT00672308|Other|Benefiber with ORS|
16296186|NCT00672308|Other|Benefiber with ORS|
16296187|NCT00672308|Other|the reduced-osmolarity WHO-ORS without added Benefiber|
16296188|NCT00672308|Other|the reduced-osmolarity WHO-ORS without added Benefiber|
16296189|NCT00672295|Drug|Dasatinib, Paclitaxel, and Carboplatin|"Dasatinib will be administered as an oral dose (tablet) as per the dose escalation (50 mg everyday - 250 mg everyday)continuously on days 2-21 in the first cycle (3 weeks) therapy and continuously (days 1-21) throughout the remainder of therapy.
~Paclitaxel will be administered on a 21-day schedule. Paclitaxel (150-175 mg/m^2) IV infused over 3 hours on day #1 of each cycle.
~Carboplatin (AUC=5-6 mg/,l/min) will be infused over 30-60 minutes every cycle via IV on day 1 of every cycle following the paclitaxel administration.
~All patients will be followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years and data entered into eDC, unless is withdrawn."
16296190|NCT00672282|Drug|Bicalutamide|150mg p.o. daily
16296191|NCT00672282|Drug|Placebo|
16296192|NCT00672256|Behavioral|Smoking Abstinence|Smokers were scanned after having quitting smoking for 24 hours, and scanned after smoking as usual.
16296193|NCT00672243|Drug|Erlotinib + sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.
16296194|NCT00672230|Dietary Supplement|Lutein supplement|Subjects will be randomized to take a lutein supplement(12mg/day) lactation weeks 5-8 or to not take a lutein supplement
16296195|NCT00672217|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBTI)|Six 15-30 minute in-person or phone sessions that incorporate cognitive, behavioral and psycho-educational techniques focused on modifying the perpetuating factors that maintain insomnia.
16296382|NCT00671034|Drug|Thioguanine|Given PO
16296383|NCT00671034|Drug|Vincristine Sulfate|Given IV
16296196|NCT00672217|Behavioral|Behavioral Placebo Treatment|Six 15-30 minute in-person or phone sessions that begin with a review of the sleep diary, a general discussion of treatment progress and tabulation of sleep parameters.
16296197|NCT00672204|Biological|Allogeneic islets of Langerhans transplant|Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
16296198|NCT00672204|Drug|Raptiva|Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;
16296199|NCT00672204|Drug|Sirolimus|Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated
16296200|NCT00672204|Drug|anti-thymocyte globulin|2.0 mg/kg on days -2, and -1 IV
16296201|NCT00672191|Biological|AGS-004|HIV-1 Immune Therapy
16296202|NCT00672178|Radiation|Stereotactic body radiation|Stereotactic body radiotherapy will be given in three cohorts of increasingly higher dose levels: Cohort 1: 6 Gy/fraction x 3 fractions (total=18 Gy) over 5 days; Cohort 2: 8 Gy/fraction x 3 fractions over 5 days; Cohort 3: 10 Gy/fraction x 3 fractions over 5 days.
16296203|NCT00672165|Biological|ACTINIUM-225-LABELED HUMANIZED ANTI-CD33 MONOCLONAL ANTIBODY HuM195|A single infusion of 225Ac-HuM195 will be administered at a starting dose of 0.5 μCi/kg. Additionally, 100 mCi of 213Bi-HuM195 have been administered with full dose cytarabine (200 mg/m2 daily for 5 days) without dose-limiting toxicity.Serial sampling of blood, urine, and bone marrow will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antileukemic effects. Three to six patients will be treated at each dose level. Dose escalation will proceed if less than 33% of patients in a cohort experience dose-limiting toxicity.Patients will be followed until completion of therapy as outlined in the study, loss to follow-up, death, or until the day the patient is removed from the study.
16296204|NCT00672152|Biological|WT1 derived peptides|"WT1 derived peptides consisting of 0.3mg (cohort 1) or 1mg (cohort 2) of each of the following peptides mixed with 1ml Montanide ISA 51 and 100mcg GM-CSF in a total volume of 2ml:
~WT peptide #1: HLA-A2 restricted: RMFPNAPYL
~WT peptide #2: HLA-A24 restricted: CMTWNQMNL
~WT peptide #3: HLA-DR15 restricted: QARMFPNAPYLPSCL
~WT peptide #4: HLA-DRw53 restricted: LKGVAAGSSSSVKWT
~Immunization with the peptide pools will be given as 200 microliter intradermal and 1.8ml subcutaneously in opposite thighs."
16296205|NCT00672139|Drug|Methylnaltrexone bromide|
16296206|NCT00672113|Drug|Adalat (Nifedipine, BAYA1040)|Nifedipine GITS 30 mg followed by Coracten 30 mg then back to nifedipine GITS 30 mg
16296207|NCT00672113|Drug|Coracten|Coracten 30 mg followed by nifedipine GITS 30 mg then back to Coracten 30 mg
16296208|NCT00672100|Drug|Ropivacaine|Initial Bolus 5 ml Ropivacaine via interscalene injection
16296209|NCT00672100|Drug|Ropivacaine|Initial Bolus 10 ml Ropivacaine via interscalene injection
16296210|NCT00672100|Drug|Ropivacaine|Initial Bolus 20 ml Ropivacaine via interscalene injection
16296211|NCT00672087|Genetic|Genomic and proteomic biomarker discovery|Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods
16296212|NCT00672074|Drug|Ipamorelin|IV
16296213|NCT00672074|Drug|placebo|IV
16296214|NCT00672061|Drug|Ramelteon or Placebo|Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.
16296215|NCT00672048|Other|Computer Tablet|A tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care.
16296216|NCT00672048|Other|Continuing Education Course|Annual standard continuing education
16296217|NCT00672048|Other|Continuing education|Annual standard continuing education materials
16296218|NCT00672035|Biological|Biological: heat-labile enterotoxin of E. coli (LT)|LT patch applied on either the deltoid or the lower back.
16296219|NCT00672022|Drug|Zavesca (Miglustat)|
16296220|NCT00672009|Drug|Ixabepilone|Ixabepilone 35 mg/m^2 intravenously over 3 hours every 21 days for 4 cycles.
16296221|NCT00671996|Drug|Mangafodipir|"Treatment will be undertaken with a ready-to-use investigative drug formulation identical to what is in diagnostic use as a contrast medium for MRI.
~Formulation content: MnDPDP 10 mmol/ml
~Administered dose per cycle: 2 μmol/kg b.w. Administration form: Ready-to-use formulation (solution). Mangafodipir or placebo (0.2 ml/kg b.w.) will be administered as an i.v. infusion over 5 min about 30 min prior to start of chemotherapy."
16296222|NCT00671996|Drug|Placebo treatment (0.9% NaCl)|Intravenous infusion, 2 micromol/kg, pretreatment 30 minutes before the start of FOLFOX treatment (during the first three FOLFOX treatments)
16296223|NCT00671983|Procedure|Neurocognitive Testing|
16296224|NCT00671970|Drug|Bevacizumab and Erlotinib|"Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. Dose of erlotinib is based on prior erlotinib monotherapy trial in RMG. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs.
~It is possible that taking erlotinib w regular medications or supplements may change how erlotinib, subject's regular medications, or subject's regular supplements work. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent."
16296225|NCT00671944|Other|Low protein diet|Low protein diet for 6.5 weeks
16296226|NCT00671931|Drug|low dexmedetomidine, low propofol|Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
16296227|NCT00671931|Drug|high dexmedetomidine, low propofol|Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
16296228|NCT00671931|Drug|Dexmedetomidine|Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
16296229|NCT00671931|Drug|Dexmedetomidin|Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
16296230|NCT00671931|Drug|Dexmedetomidine|Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
16296277|NCT00671593|Biological|House Dust Mite|"Dermatophagoides pteronyssinus: nebulized inhaled dosing is every 10 minutes per protocol limits at the following Allergen Concentration , (5 breaths of duration 0.8 seconds using a dosimeter) 0.0 AU, 0.3 AU/ml,
~1 AU/ml, 3 AU/ml, 10 AU/ml, 30 AU/ml, 100 AU/ml, 300 AU/ml, 1000 AU/ml, 3000 AU/ml"
16296384|NCT00671021|Other|Platelet aggregation|Platelet aggregation TxA2 formation
16296385|NCT00671008|Drug|biphasic insulin aspart 30|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16296231|NCT00671918|Drug|Lymphoseek|Breast Cancer: Intradermal admin of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site OR periareolar administration of Lymphoseek: Inject 0.2-.04 mL in multiple divided doses at the margin of the areola OR subareolar administration of Lymphoseek: Inject 0.2-0.4 in multiple divided injections or a single injection in subareolar area as a subcutaneous injection OR peritumor administration of Lymphoseek: Inject 2.0-4.0 mL in multiple divided injections, intraparenchemally surrounding the tumor or biopsy cavity. For melanoma pts intradermal administration of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site.
16296232|NCT00671905|Procedure|GP ablation|HF stimulation-guided and anatomic ablation of the main right and left atrial GP
16296233|NCT00671905|Procedure|PV isolation|Circumferential PV isolation
16296234|NCT00671892|Biological|Lipopolysaccharide endotoxin|"Delivered in nebulized form expressed in activity units(endotoxin units -EU).
~Subjects receive each dose 30 min after completing the previous dose, dose duration is approximately 10 minutes:
~Challenge One first saline then 5000 EU 10,000 EU 20,000 EU
~Challenge 1 and 2 must be at least 2 weeks apart.
~Challenge 2 Saline 40,000 EU 80,000 EU"
16296235|NCT00671879|Drug|Carisoprodol SR 700 mg|700 mg twice daily tablet
16296236|NCT00671879|Drug|Carisoprodol SR 500 mg|carisoprodol SR 500 mg tablet
16296237|NCT00671879|Drug|Placebo|placebo tablet
16296238|NCT00671853|Drug|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
16296239|NCT00671853|Drug|Placebo for quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
16296240|NCT00671827|Behavioral|Questionnaire|Questionnaires each taking less than 10 minutes to complete.
16296241|NCT00671814|Drug|TR-701|TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.
16296242|NCT00671814|Drug|linezolid|Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.
16296243|NCT00671814|Drug|placebo|Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.
16296244|NCT00671801|Drug|Irinotecan|200 mg/m^2 by vein over 90 minutes once every 2 weeks on days 1 and 15.
16296245|NCT00671801|Drug|Lenalidomide|Given orally at escalating doses beginning 7.5 mg/day on Cycle 1 Days 1-21 and 10 mg/day on Cycle 2 Days 1-21.
16296246|NCT00671788|Drug|Dasatinib|Given orally
16296247|NCT00671788|Other|Laboratory Biomarker Analysis|Correlative studies
16296248|NCT00671749|Drug|adapalene gel, 0.3%|Applied once daily at bedtime
16296249|NCT00671749|Drug|clindamycin/benzoyl peroxide gel|Applied once daily in the morning
16296250|NCT00671736|Drug|Moli1901|2,5 ml inhalation solution, 8 weeks treatment period
16296251|NCT00671736|Drug|Moli1901 placebo|2,5 ml placebo solution, 8 weeks treatment period
16296252|NCT00671723|Drug|Normal saline:|Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
16296253|NCT00671723|Drug|Hypertonic Saline|Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
16296254|NCT00671723|Drug|Dornase alpha|2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
16296255|NCT00671710|Drug|Aminolevulinic Acid|Escalating doses (10mg/kg, 20mg/kg, 30mg/kg) of Aminolevulinic Acid administered orally 3 hours prior to surgery to enhance visualization of malignant brain tumor.
16296256|NCT00671697|Drug|Arsenic Trioxide|
16296257|NCT00671697|Drug|Decitabine|
16296258|NCT00671684|Procedure|Endoscopic Mucosal Resection (EMR)|EMR is a common procedure in gastroenterology. The technique involves placing a band around a piece of mucosa in the GI tract. The band and the tissue are then removed using a cautery snare. The technique can be used to obtain tissue for diagnostic purposes or to remove lesions for therapeutic purposes.
16296259|NCT00671671|Drug|Small Molecule Agent (PF-868554)|Study drug will be administered 700mg BID in the fed state for three days.
16296260|NCT00671671|Drug|Small Molecule Agent (PF-868554)|Study drug will be given 450mg BID for a duration of 10 days.
16296261|NCT00671658|Drug|Rituximab|375 mg/m2 by vein
16296262|NCT00671658|Drug|Cyclophosphamide (CTX)|300 mg/m2 by vein
16296263|NCT00671658|Drug|Doxorubicin|50 mg/m2 by vein
16296264|NCT00671658|Drug|Vincristine|2 mg by vein
16296265|NCT00671658|Drug|Dexamethasone|40 mg by vein or by mouth (P.O.)
16296266|NCT00671658|Drug|Methotrexate (MTX)|"12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7
~200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8"
16296267|NCT00671658|Drug|Cytarabine|"100 mg intrathecal for Courses 1,3,5,7
~3 gm/m2 by vein for Courses 2,4,6,8"
16296268|NCT00671658|Drug|G-CSF|10 ug/kg subcutaneous injection
16296269|NCT00671658|Drug|Mesna|600 mg/m2 a day by vein
16296270|NCT00671658|Drug|Pegylated asparaginase|2000 International units/m2 by vein
16296271|NCT00671658|Drug|Pegfilgrastim|6 mg (flat dose) within 72 hrs after completion of chemotherapy
16296272|NCT00671658|Drug|Solumedrol|40 mg by vein for Courses 2,4,6,8
16296273|NCT00671645|Drug|capecitabine, bevacizumab|Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29
16296274|NCT00671632|Drug|Ramelteon, triazolam, and placebo (56 possible combinations total)|"Randomized sequence over eight consecutive days to include the following:
~Ramelteon 16 mg, tablets, orally, one day only;
~Ramelteon 80 mg, tablets, orally, one day only;
~Ramelteon 160 mg, tablets, orally, one day only;
~Triazolam 0.25 mg, capsules, orally, one day only;
~Triazolam 0.50 mg, capsules, orally, one day only;
~Triazolam 0.75 mg, capsules, orally, one day only;
~Ramelteon placebo-matching tablets, orally, one day only, OR Triazolam placebo-matching capsules, orally, one day only;
~Additional dose of study medication or placebo, tablets or capsules, orally, one day only."
16296275|NCT00671619|Drug|ESBA105|eye drops
16296276|NCT00671606|Procedure|Intraoperative Lymphatic Mapping|Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.
16296376|NCT00671034|Drug|Mercaptopurine|Given PO
16296278|NCT00671593|Biological|Diluent|Greer lab allergen extract diluent (0.5% sodium chloride, 0.25% sodium bicarbonate, 50% glycerin (v/v), and 0.4% phenol)nebulized inhaled dosing is every 10 minutes per protocol limits at the following Diluent Concentration, (5 breaths of duration 0.8 seconds using a dosimeter)
16296279|NCT00671580|Drug|PZ-601|750 mg
16296280|NCT00671580|Drug|PZ-601|1000 mg
16296281|NCT00671580|Drug|Standard of Care|as directed
16296282|NCT00671567|Drug|Ramelteon|Ramelteon, 8 mg, tablets, orally, once daily for up to 5 weeks.
16296283|NCT00671567|Drug|Ramelteon|Ramelteon, 16 mg, tablets, orally, once daily for up to 5 weeks.
16296284|NCT00671567|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.
16296285|NCT00671554|Biological|Melaxin (autologous dendritoma vaccine) and BCG|Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
16296286|NCT00671541|Drug|Merogel Nasal Stent and Nasopore Stent|Merogel Nasal Stent and Nasopore Stent
16296287|NCT00671541|Drug|Nasopore Stent and either Gentamycin or Bacitracin|Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
16296288|NCT00671528|Drug|Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)|Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
16296289|NCT00671528|Drug|Cream (betamethasone diproprionate and gentamicin)|Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
16296290|NCT00671528|Drug|Cream (betamethasone diproprionate)|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
16296291|NCT00671515|Drug|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
16296292|NCT00671502|Drug|Carisoprodol SR|700 mg twice daily
16296293|NCT00671502|Drug|Carisoprodol SR|500 mg twice daily
16296294|NCT00671502|Drug|Placebo|Placebo tablet
16296295|NCT00671489|Dietary Supplement|Omega-3 Polyunsaturated Fatty Acid|A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week.
16296296|NCT00671476|Drug|pegylated liposomal doxorubicin hydrochloride|
16296297|NCT00671476|Genetic|DNA methylation analysis|
16296298|NCT00671476|Genetic|TdT-mediated dUTP nick end labeling assay|
16296299|NCT00671476|Genetic|fluorescence in situ hybridization|
16296300|NCT00671476|Genetic|loss of heterozygosity analysis|
16296301|NCT00671476|Genetic|polymerase chain reaction|
16296302|NCT00671476|Other|immunoenzyme technique|
16296303|NCT00671476|Other|immunohistochemistry staining method|
16296304|NCT00671476|Other|laboratory biomarker analysis|
16296305|NCT00671476|Procedure|breast duct lavage|
16296306|NCT00671476|Procedure|neoadjuvant therapy|
16296307|NCT00671476|Procedure|therapeutic conventional surgery|
16296308|NCT00671463|Procedure|Pancreatic duct stenting|In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.
16296309|NCT00671437|Procedure|FDG-PET/CT|
16296310|NCT00671437|Drug|Cetuximab|
16296311|NCT00671424|Drug|Hydrochlorothiazide (HCTZ)|
16296312|NCT00671424|Drug|Remogliflozin etabonate (GSK189075)|
16296313|NCT00671424|Drug|Furosemide|
16296314|NCT00671411|Drug|Ultrasound with intravenous microbubble contrast injection|"Intravenous line will be inserted. After the ultrasound microbubble contrast has been suspended into solution, contrast will be injected intrav via hand bolus with a total activated suspension of 0.2 mL (30 uL octaflouropropane),followed by 10 mL saline flush, with option to rebolus 4 addit time's for tot dose of 150 uL. Post contrast cine images of renal mass will be obtained on commercially available US units primarily using low mechanical index settings & Contrast Pulsed Sequence (CPS®) technique. Images will be acquired at predetermined intervals, for up to 8 min post contrast admin. Manufacturer's guidelines incl immediate post flush image capture, as well as post admin image capture at intervals as 1 min, 2 , 4 & 8 mins. Additional, temporary higher mechanical index imaging of kidney for the purpose of flash bubble destruction may be optionally triggered using manufacturer's preset settings & energy w/i FDA guidelines. This will only be performed while imaging the kidney."
16296315|NCT00671398|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally for one night only.
16296316|NCT00671398|Drug|Ramelteon|Ramelteon 16 mg, tablets, orally for one night only
16296317|NCT00671398|Drug|Placebo|Ramelteon placebo-matching tablets, orally for one night only
16296318|NCT00671372|Drug|FOLFIRI regimen|Intravenous repeating dose
16296319|NCT00671372|Drug|bevacizumab|Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
16296320|NCT00671372|Drug|cetuximab|Intravenous repeating dose
16296321|NCT00671372|Drug|dulanermin|Intravenous repeating dose
16296322|NCT00671372|Drug|irinotecan|Intravenous repeating dose
16296323|NCT00671359|Drug|TR-701 600mg|TR-701 600mg
16296324|NCT00671333|Procedure|LRTI|"Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, trapeziectomy using a cruciate osteotomy and rongeurs, creation of a metacarpal base bone tunnel using a high speed burr, harvesting of entire FCR tendon through two transverse volar incisions, ligament reconstruction and tendon interposition using Fibre Wire suture. Closure of capsule with Vicryl. Closure of skin with running Prolene suture."
16296377|NCT00671034|Drug|Methotrexate|Given IV, IT, or PO
16296378|NCT00671034|Drug|Pegaspargase|Given IV
16296379|NCT00671034|Other|Pharmacological Study|Correlative studies
16296380|NCT00671034|Drug|Prednisone|Given IV or PO
16296381|NCT00671034|Radiation|Radiation Therapy|Some patients undergo RT
16296325|NCT00671333|Procedure|Ascension PyroDisk|Dorsal radial incision, capsulotomy between EPB and APL protecting the radial artery, distal 2 mm of trapezium and dorsal cortex of both trapezium and metacarpal removed using osteotomes/rongeurs. A hole is drilled through the trapezium from dorsal to resected distal surface, and a second hole is drilled through the first metacarpal from the resected base to the dorsal surface. A slip of FCR is harvested. The tendon is woven through the trapezium, the central hole in the device, and the metacarpal tunnel then sutured back onto itself. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.
16296326|NCT00671320|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
16296327|NCT00671320|Drug|diclofenac|diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
16296328|NCT00671307|Drug|rhu-pGelsolin|IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
16296329|NCT00671307|Drug|Placebo|Vehicle control given as IV infusion over 1 hour
16296330|NCT00671294|Drug|Ramelteon and Placebo (9 possible combinations total)|"Randomized sequence over two consecutive nights for a total of three treatment periods to include the following:
~Ramelteon 4 mg, tablets, orally over two nights
~Ramelteon 8 mg, tablets, orally over two nights
~Ramelteon placebo-matching tablets, orally over two nights"
16296331|NCT00671281|Drug|Tranexamic acid|Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
16296332|NCT00671281|Drug|Placebo|Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
16296333|NCT00671268|Biological|AL0704rP|strict subcutaneous
16296334|NCT00671268|Biological|Placebo|strict subcutaneous
16296335|NCT00671255|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
16296336|NCT00671255|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.
16296337|NCT00671255|Drug|Placebo|Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.
16296338|NCT00671216|Drug|GSK233705|Subjects will receive 200 (mcg) microgram once daily as a single dose
16296339|NCT00671216|Drug|GW642444|Subjects will receive 50 mcg once daily as a single dose
16296340|NCT00671216|Drug|GSK233705 and GW642444|Subjects will receive combination of GSK233705 200 mcg and GW642444 50 mcg as a single oral dose
16296341|NCT00671216|Drug|Placebo|Placebo matching study medication will be inhaled by subjects
16296342|NCT00671203|Procedure|Reestablish colon blood flow|If ischemia is detected, and the detection in consistent with the physician's clinical view, blood flow to the colon is established using any of the known techniques that would be used had the diagnosis been made in the absence of T-Stat, which include changes in the deployment of stents and/or coils, reanastomosis, reimplantation, or stenting, of obstructed vessels, or other established techniques.
16296343|NCT00671190|Drug|Ramelteon|Ramelteon 1 mg, tablets, orally once daily for up to 5 days
16296344|NCT00671190|Drug|Ramelteon|Ramelteon 2 mg, tablets, orally once daily for up to 5 days
16296345|NCT00671190|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally once daily for up to 5 days
16296346|NCT00671190|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally once daily for up to 5 days
16296347|NCT00671190|Drug|Placebo|Ramelteon placebo-matching tablets, orally once daily for up to 5 days
16296348|NCT00671177|Procedure|water immersion colonoscopy|instillation of 300cc of water in the rectum
16296349|NCT00671177|Procedure|standard air colonoscopy|air instillation in colon for visualization
16296350|NCT00671151|Drug|Theophylline|Theophylline 100 mg bid for 3 months
16296351|NCT00671138|Biological|Necator americanus|10 necator americanus larvae will be inoculated at week 0 with a further 5 larvae inoculated at week 12
16296352|NCT00671138|Other|Sham inoculation|A diluted amount of McIlhenny & Co Tabasco Pepper Sauce will be applied via a gauze dressing at weeks 0 and 12.
16296353|NCT00671125|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
16296354|NCT00671125|Drug|Ramelteon|Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
16296355|NCT00671125|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
16296356|NCT00671112|Drug|Bortezomib|"Patients will be assigned to one of the following dose levels of Bortezomib: 0.7mg/m2, 1.0 mg/m2, or 1.3mg/m2 on days 1,4,8,11 of a 21 day cycle.
~The appropriate amount of bortezomib will be drawn from the injection vial and administered as an intravenous (IV) push or sub-cutaneously over 3 to 5 seconds followed by a standard saline flush or through a running IV line."
16296357|NCT00671112|Drug|Everolimus|Everolimus 5 mg PO every other day, 5 mg by mouth (PO) daily, or 10 mg PO daily
16296358|NCT00671099|Dietary Supplement|Omega-3 Polyunsaturated Fatty Acid|A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week.
16296359|NCT00671099|Dietary Supplement|Placebo|Placebo
16296360|NCT00671086|Drug|Ramelteon|Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.
16296361|NCT00671086|Drug|Ramelteon|Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.
16296362|NCT00671073|Drug|Oglemilast|Oglemilast low dose, oral administration, once daily for 12 weeks
16296363|NCT00671073|Drug|Placebo|Placebo, oral administration, once daily for 12 weeks
16296364|NCT00671073|Drug|Oglemilast|Oglemilast middle dose, oral administration, once daily for 12 weeks
16296365|NCT00671073|Drug|Oglemilast|Oglemilast high dose, oral administration, once daily for 12 weeks
16296366|NCT00671060|Drug|Misoprostol|200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.
16296367|NCT00671060|Drug|Misoprostol|100 mcg buccal misoprostol administered every 6 hours for upto 48 hours
16296368|NCT00671047|Other|non-interventional|SLE nature history observational
16296369|NCT00671034|Drug|Calaspargase Pegol-mknl|Given IV
16296370|NCT00671034|Drug|Cyclophosphamide|Given IV
16296371|NCT00671034|Drug|Cytarabine|Given IV, IT, PO, or SC
16296372|NCT00671034|Drug|Daunorubicin Hydrochloride|Given IV
16296373|NCT00671034|Drug|Dexamethasone|Given PO or IV
16296374|NCT00671034|Drug|Doxorubicin Hydrochloride|Given IV
16296375|NCT00671034|Other|Laboratory Biomarker Analysis|Correlative studies
16296386|NCT00671008|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16296387|NCT00670995|Behavioral|Interactive Tobacco Education|Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco
16296388|NCT00670982|Drug|bevacizumab|Given intravenously every 2 weeks
16296389|NCT00670982|Drug|vinorelbine|Given intravenously once a week
16296390|NCT00670982|Drug|trastuzumab|Given intravenously once a week
16296391|NCT00670956|Drug|Betamethasone|12 mg intramuscularly x 2 doses 24 hours apart
16296392|NCT00670956|Drug|Placebo|PLACEBO: IM x 2 doses 24 hours apart
16296393|NCT00670943|Other|Platelet function testing|
16296394|NCT00670930|Drug|omalizumab at a dose of 0.016mg/kg/IU/mL|
16296395|NCT00670930|Drug|Placebo|
16296396|NCT00670917|Other|questionnaire administration|
16296397|NCT00670917|Procedure|acupressure therapy|
16296398|NCT00670917|Procedure|biopsy|
16296399|NCT00670917|Procedure|bone marrow aspiration|
16296400|NCT00670917|Procedure|pain therapy|
16296401|NCT00670904|Other|Pharmacist-delivered group program for smoking cessation|Participants assigned to the treatment group participated in a pharmacist-delivered program at the clinic. The six-hour program consisted of three in-person sessions delivered at 2-week intervals over 5 weeks to a small group of smokers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.
16296402|NCT00670904|Other|Brief standard care session for smoking cessation delivered over the telephone|Those assigned to the control group received one 5 to 10 minute session delivered by the clinical pharmacist over the telephone that included all the components of standard care recommended by the Clinical Practice Guidelines for brief interventions delivered by health care providers. Participants were offered their choice of one medication either bupropion IR or nicotine patch using doses and durations based on current medical practices. Participants receiving bupropion received a quantity sufficient to complete 12 weeks of therapy. Participants receiving nicotine patches received a quantity sufficient to complete 8 weeks of step-down therapy.
16296403|NCT00670891|Procedure|oxygen (Hyperbaric Oxygen Therapy)|"Current Accepted Applications of HBOT (2008) Jan 2003, ANDI International
~Air or Gas Embolus
~Decompression Illness
~Carbon Monoxide poising
~Clostridial Myonecrosis (Gas Gangrene)
~Necrotizing Fasciitis
~Crush Injury (Compartment syndromes)
~Selected Problem Wounds
~Compromised Skin Flaps or Grafts
~Refractory Osteomyelitis
~Exceptional Anemia due to Blood loss
~Osteoradionecrosis
~Thermal Burns and Radiation Tissue Damage
~Diabetic Wounds
~Intra-Cranial Abscess
~Brain Injury and other Head Trauma
~Cerebral Palsy
~High Altitude Sickness
~Lyme disease"
16296404|NCT00670878|Drug|3 x FEC 3 x DOC / Gemcitabine|3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22
16296405|NCT00670878|Drug|3 x FEC 3 x DOC|3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22
16296406|NCT00670865|Other|Electronic discharge summary system|The customized electronic discharge summary program will be used to generate patient discharge summaries.
16296407|NCT00670852|Procedure|X-rays and CT scan|CT Scan x-rays
16296408|NCT00670839|Biological|GenHevac-B|1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6
16296409|NCT00670839|Biological|GenHevac-B|2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6
16296410|NCT00670826|Device|vitalHEAT vH2 Temperature Management System|The vH2 system utilizes a combination of localized heat and vacuum application to one hand & forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core.
16296411|NCT00670826|Device|Arizant Healthcare Bair Hugger Temperature Management System|The Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body
16296412|NCT00670813|Drug|Modafinil (Vigil)|Oral application of 2 x 100 mg Modafinil each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period
16296413|NCT00670813|Drug|Placebo|Oral application of 2 x 100 mg Placebo each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period
16296414|NCT00670800|Drug|Metformin|Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times daily (TID), adding a 500 mg tablet after supper. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia.
16296415|NCT00670787|Drug|Combination pill of losartan and hydrochlorothiazide|Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning
16296452|NCT00670501|Drug|Calcium Supplement|Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
16296453|NCT00670501|Drug|Vitamin D Supplement|Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
16296454|NCT00670488|Drug|MK-2206|MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.
16296534|NCT00669916|Drug|Placebo|single infusion of placebo
16296535|NCT00669903|Drug|AZD0328|
16296416|NCT00670774|Drug|Eculizumab|"Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery.
~Patients will be given 900 mg of eculizumab on Day 1 post-transplant.
~Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant
~At week 4, patients will be assessed for B cell flow cytometry cross match (FCXM). Patients with B cell FCXM less than 200 will stop eculizumab treatment. Patients with B cell FCXM greater than or equal to 200 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly. Similar discontinuation assessments will be performed at week 9, 26, 39 and 52.
~In addition, eculizumab 600 mg will be administered immediately after each plasmapheresis (PP) and immediately after any fresh frozen plasma (FFP) that is given post-transplant during the treatment period"
16296417|NCT00670761|Drug|misoprostol|comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
16296418|NCT00670761|Procedure|MVA|comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
16296419|NCT00670748|Biological|Anti-NY ESO-1 T-cell receptor PBL|Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
16296420|NCT00670748|Drug|aldesleukin|Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses)
16296421|NCT00670748|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16296422|NCT00670748|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16296423|NCT00670748|Biological|ALVAC NY ESO-1 vaccine|Approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approximately 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
16296424|NCT00670722|Drug|insulin aspart|Intervention at the discretion of the physician
16296425|NCT00670722|Drug|insulin detemir|Intervention at the discretion of the physician
16296426|NCT00670722|Drug|biphasic insulin aspart 30|Intervention at the discretion of the physician
16296427|NCT00670696|Drug|Rapydan|Topical anaesthetic plaster
16296428|NCT00670696|Drug|tetracaine gel|Topical tetracaine gel
16296429|NCT00670683|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16296430|NCT00670670|Device|CPP-ACP (GC Tooth Mousse)|Calcium and phosphate
16296431|NCT00670670|Device|CPP-ACP (GC MI Paste Plus)|Calcium, phosphate and fluoride
16296432|NCT00670657|Drug|AmBisome|Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture
16296433|NCT00670644|Other|questionnaire administration|Completed self-report form
16296434|NCT00670644|Other|survey administration|Completed self-report form-other
16296435|NCT00670644|Procedure|quality-of-life assessment|Completed self-report form qol
16296436|NCT00670631|Combination Product|tandem autologous transplantation|"DPACE: dexamethasone 20 mg days 1-4 and 8-11, cisplatin 10 mg/m2 days 1-4, Adriamycin 10 mg/m2 days 1-4, cyclophosphamide 400 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4.
~Transplant 1: Dexamethasone 20 mg days -4 to -1 and +2 to +5. Velcade 1mg/m2 on days -4,-1, +2, and +5. Thalidomide 100mg on day -4 to day +5. Melphalan, 100 mg/m2 on days -4 and -1.
~Transplant 2: Dexamethasone 20 mg on days -4 to -1 and +2 to +5. BCNU 300mg/m2 on day -4. Melphalan 140 mg/m2 on day -1. Velcade 1mg/m2 on days -4, -1, +2, +5. Gemcitabine 1000 mg/m2 on days -4 + -1.
~Maintenance year 1: Bortezomib 1.0 mg/m2 on days 1, 4, 15,18 every cycle. Thalidomide, 100 mg . Dexamethasone,20 mg,on days 1-4 & 15-18 every cycle.
~Maintenance year 2: Dexamethasone, 20 mg,days 1-4 every cycle."
16296437|NCT00670618|Device|CPP-ACP (GC Tooth Mousse)|Calcium and phosphate
16296438|NCT00670618|Device|CPP-ACP (GC MI Paste Plus)|Calcium, phosphate and fluoride
16296439|NCT00670618|Device|Fluoride (Elmex Medical Gel)|Fluoride
16296440|NCT00670605|Other|medical chart review|
16296441|NCT00670605|Other|study of socioeconomic and demographic variables|
16296442|NCT00670592|Drug|HCD122|
16296443|NCT00670566|Drug|irbesartan/hydrochlorothiazide|50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks
16296444|NCT00670553|Drug|panobinostat|
16296445|NCT00670540|Other|procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis|patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible
16296446|NCT00670527|Procedure|[18F] Fluorocholine PET/CT|"The patients fast 6 hours before the [18F]Fluorocholine PET/CT scan. [18F]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast.
~The radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark."
16296447|NCT00670514|Behavioral|Nix Individual|Eight 40-minutes sessions at the local dental clinic during 4 months. Written material and counseling by a dental hygienist with special training in smoking cessation, according to a fixed program. A traditional smoking cessation program with a mixture of behavior therapy, coaching and pharmacological advises. Two questionnaires.
16296448|NCT00670514|Behavioral|Fimpa dig fri|"One 30-minute counseling session at the local dental clinic, focusing on explaining the content of a traditional self-help program (Fimpa dig fri). The leaflet contains an 8-week program with instructions and tasks to perform. Two questionnaires."
16296449|NCT00670501|Drug|teriparatide|40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
16296450|NCT00670501|Drug|teriparatide|20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
16296451|NCT00670501|Drug|Placebo|Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
16296455|NCT00670475|Drug|Piroxicam|In this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients.
16296456|NCT00670475|Dietary Supplement|Olive Oil|"virgin olive oil prepared directly from olive fruit from olive gardens of north of iran, Gilan province will packaged in a 60 g anonymous tubes."
16296457|NCT00670462|Behavioral|Standard Behavioral Treatment (SBT)|SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training. MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. Between each segment, participants are left on their own for 4 weeks with instructions to continue regular weighing but otherwise to make their own choices about what to do for weight control.
16296458|NCT00670462|Behavioral|Maintenance-Tailored Treatment (MTT)|
16296459|NCT00670449|Drug|Fingolimod|Fingolimod was supplied in capsules.
16296460|NCT00670436|Device|paclitaxel eluting PTCA balloon catheter (SeQuent Please)|paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
16296461|NCT00670436|Device|paclitaxel eluting Taxus stent (Boston Scientific)|paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
16296462|NCT00670423|Drug|Tacrolimus|Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL)
16296463|NCT00670423|Drug|Sirolimus|Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL)
16296464|NCT00670423|Drug|Bortezomib|"Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used:
~Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3
~Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3
~Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3"
16296465|NCT00670410|Procedure|Related donor transplant|Patients with a related donor will get reduced intensity transplant conditioning with busulfan and fludarabine.
16296466|NCT00670410|Procedure|Cord blood transplant|Patients with a matched cord blood donor will get reduced intensity conditioning with busulfan, fludarabine, and ATG.
16296467|NCT00670410|Drug|Busulfan|Busulfan (Busulfex) [4mg/kg/dose for patients < 4 years; 3.2 mg/kg/dose for patients > 4 years] will be given IV in 0.9% sodium chloride or D5W to a final concentration > 0.5 mg/mL solution for infusion equal to 10 times the volume of diluent to Busulfex, through a central venous access device over 3 hours once daily.
16296468|NCT00670410|Drug|Thymoglobulin|Patients with an umbilical cord blood donor will also receive Thymoglobulin (ATG-rabbit) during the preparative regimen.
16296469|NCT00670410|Drug|Fludarabine|Fludarabine 30 mg/m2 x 5 days, total dose = 150 mg/m2. Patients < 12 kg will receive Fludarabine 1 mg/kg x 5 days, total dose = 5 mg/kg. Fludarabine will be given IV in 100 ml (or to a concentration of 1 mg/mL) of D5W or 0.9% sodium chloride, and infused over 30 min on Days -6 to 2.
16296470|NCT00670397|Drug|HPPH|IV
16296471|NCT00670384|Biological|Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)|Sublingual drops
16296472|NCT00670384|Biological|Placebo|Sublingual drops
16296473|NCT00670358|Biological|pegfilgrastim|
16296474|NCT00670358|Biological|rituximab|
16296475|NCT00670358|Drug|cyclophosphamide|
16296476|NCT00670358|Drug|doxorubicin hydrochloride|
16296477|NCT00670358|Drug|lenalidomide|
16296478|NCT00670358|Drug|prednisone|
16296479|NCT00670358|Drug|vincristine sulfate|
16296480|NCT00670358|Genetic|polymorphism analysis|
16296481|NCT00670358|Other|laboratory biomarker analysis|
16296482|NCT00670345|Drug|Tranexamic Acid|Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
16296483|NCT00670345|Drug|Placebo|Patients belonging to the control group will receive the same volume of saline infusions.
16296484|NCT00670319|Drug|Raloxifene HCL|Raloxifene HCL 60 mg orally once daily
16296485|NCT00670319|Drug|Raloxifene HCL|Raloxifene HCL 120 mg orally once daily
16296486|NCT00670319|Drug|Placebo|Placebo one tab orally per day
16296487|NCT00670306|Drug|Cetrorelix Pamoate|Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
16296488|NCT00670293|Radiation|Positron Emission Tomography (PET) using [11C]raclopride|Participants with AN will undergo three PET scans at two separate time points. The first scan will occur when participants are underweight (but not less than 75% ideal body weight), and the second and third scans will occur 2 to 4 weeks after participants have accomplished weight restoration. Healthy participants will have two PET scans at a single timepoint.
16296489|NCT00670293|Drug|Methylphenidate|The second PET scan for healthy participants and third PET scan for participants with AN will be performed after administration of 60 mg of methylphenidate, a psychostimulant that allows for accumulation of dopamine (DA) extraneuronally.
16296490|NCT00670293|Procedure|Magnetic Resonance Imaging (MRI) scan|Participants with AN will undergo two MRI scans, and healthy participants will undergo one MRI scan. The scans will be conducted in conjunction with the PET scans.
16296491|NCT00670280|Behavioral|Motivational Interviewing intervention|Those randomized to receive the Motivational Interviewing intervention will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. Each visit will consist of a 45 minute session in which household smoking practices will be assessed and discussed. Two weeks after the child has been discharged from the hospital, the counselor will contact participants via telephone for a third 20-30 minute telephone meeting. After the third contact with the counselor, a letter will be mailed to participants summarizing information covered in the three meetings.
16296492|NCT00670280|Behavioral|Usual Care|Those randomized to receive the Usual Care intervention will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention.
16296493|NCT00670280|Behavioral|Usual Care - Reduced Measurement|Those randomized to the Usual Care - Reduced Measurement intervention will receive the same written information on secondary smoke and infant health as the Usual Care intervention but will be assessed only at the 6-month timepoint.
16296536|NCT00669903|Drug|Placebo|
16296494|NCT00670267|Drug|nadolol|Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
16296495|NCT00670254|Drug|Placebo|Application is identical to experimental arm
16296496|NCT00670254|Drug|Hydrocortisone|50 mg loading dose, continuous infusion of 200 mg/d for 5 d, 100 mg/d for 2d, 50 mg/d for 2 d, and 25 mg/d for 2 d.
16296497|NCT00670241|Drug|calcipotriol and betamethasone (LEO 80185 gel)|Once daily application
16296498|NCT00670241|Drug|LEO 80185 vehicle|Once daily application
16296499|NCT00670241|Drug|Tacalcitol ointment|Once daily application
16296500|NCT00670228|Drug|Insulin Glargine (LANTUS)|Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL
16296501|NCT00670228|Drug|Insulin Glulisine (Apidra)|"Prior PCI, subjects received a single IV bolus of insulin glulisine. The dose was 0.025 U/kg based upon patient reported weight.
~Then IV insulin glulisine infusion was started within one hour of the IV insulin glulisine bolus and administered at a minimum rate of 2 U/h for 48 hours. The infusion was titrated in order to achieve and maintain the plasma glucose between 90 and 130 mg/dL."
16296502|NCT00670228|Drug|Standard Therapy|Standard insulin therapy titrated to blood sugar control
16296503|NCT00670215|Drug|Ciprofloxacin single dose|Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP.
16296504|NCT00670215|Drug|Ciprofloxacin triple dose|Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP.
16296505|NCT00670202|Drug|Fasudil Hydrochloride|Fasudil 40 mg three times a day x 14 days
16296506|NCT00670202|Drug|Placebo Oral Tablet|Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
16296507|NCT00670189|Drug|BMS-833923 (XL139)|Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit
16296508|NCT00670176|Behavioral|REHAB (Pre- and postoperative cardiopulmonary rehabilitation)|
16296509|NCT00670163|Behavioral|Enhanced Partner Therapy (EPT)|EPT, a biomedical intervention, is designed to reduce the rate of sexually transmitted infection (STI) reinfection and, therefore, incident STIs. Men who have sex with men (MSM) with incident STIs will be given partner treatment packets that contain informational brochures, reference cards, prophylactic medications, and condoms for their sexual partners.
16296510|NCT00670163|Behavioral|Communidades Positivas (CPOS)|The behavioral intervention, CPOS, is based on a combination of social-action theory and diffusion of innovation and is designed to reduce the frequency of unprotected sex with nonprimary partners. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and partners. CPOS will include a training program of at least 14 sessions. During these sessions, MSM leaders will be provided with information about HIV/STIs and their prevention and ways to strengthen leadership skills. The 2-hour group sessions will occur two times a week for 7 weeks. While the training sessions are underway, MSM leaders will be asked to work with community leaders to form a community center from which they will carry out HIV/STI prevention and promotion of sexual health activities for 18 months.
16296511|NCT00670163|Behavioral|Standard Care|Standard care will consist of usual care for STIs.
16296512|NCT00670150|Drug|NRX 195183 (retinoid analogue)|30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation
16296513|NCT00670150|Drug|Arsenic Trioxide|0.15mg/kg/day over 2hrs VI on day 1-5 x 4 weeks. 2 weeks rest then repeat x 3 more cycles.
16296514|NCT00670124|Device|Hypothermia by the use of Blanketrol II, Cincinnati Sub-Zero|The patients are placed on a cooling mattress and body-core temperature is regulated to 33° C.
16296515|NCT00670111|Device|Insignia Plus / Ultra (Guidant/Boston Scientific)|Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
16296516|NCT00670098|Procedure|Bariatric surgery|patients receive either gastric bypass or lap-band
16296517|NCT00670098|Behavioral|lifestyle intervention (behavioral weight loss)|participants attend biweekly weight loss counseling group sessions
16296518|NCT00670059|Genetic|single embryo transfer without aneuploidy screening|without aneuploidy testing for the chromosomes XY, 13, 16, 18, 21, 22
16296519|NCT00670059|Genetic|single embryo transfer with aneuploidy screening|with aneuploidy testing for the chromosomes XY, 13, 16, 18, 21, 22
16296520|NCT00670046|Drug|valproic acid|given orally
16296521|NCT00670046|Other|standard of care follow-up|participant follow the standard of care for patient with metastatic prostate cancer
16296522|NCT00670033|Drug|Travoprost ophthalmic solution (new formulation)|
16296523|NCT00670033|Drug|Travoprost ophthalmic solution, 0.004%|
16296524|NCT00670033|Drug|Vehicle|Inactive ingredients used as a placebo
16296525|NCT00670020|Procedure|supplemental perioperative oxygen|increased perioperative oxygen verses non-interventional oxygen
16296526|NCT00670007|Biological|Alpha1- proteinase inhibitor [human]|Lyophilized preparation of 60 mg/kg body weight intravenously once per week
16296527|NCT00669994|Drug|Ciprofloxacin|Cipro XR 500 mg tablets taken once daily
16296528|NCT00669981|Behavioral|Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)|CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.
16296529|NCT00669955|Drug|Omeprazole, amoxicillin, clarithromycin|Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID
16296530|NCT00669955|Drug|Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole|Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.
16296531|NCT00669942|Biological|AIN457|AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
16296532|NCT00669942|Drug|Placebo|Placebo to AIN457
16296533|NCT00669916|Biological|AIN457|single infusion of 3 mg/kg
16296650|NCT00669318|Drug|sargramostim|
16296537|NCT00669890|Drug|Gemtuzumab Ozogamicin|Dose Escalation
16296538|NCT00669890|Drug|Busulfan|Conditioning Regimen
16296539|NCT00669890|Drug|Cyclophosphamide|Conditioning Regimen
16296540|NCT00669890|Drug|Thymoglobulin|(Unrelated Donors only)
16296541|NCT00669890|Drug|Tacrolimus|GVHD Prophylaxis
16296542|NCT00669890|Drug|Mycophenolate Mofetil|GVHD Prophylaxis
16296543|NCT00669890|Drug|Methotrexate|GVHD Prophylaxis
16296544|NCT00669877|Drug|Rituximab|375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses.
16296545|NCT00669877|Drug|Cyclophosphamide|300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses).
16296546|NCT00669877|Drug|Doxorubicin|50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
16296547|NCT00669877|Drug|Vincristine|2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses)
16296548|NCT00669877|Drug|Dexamethasone|40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses)
16296549|NCT00669877|Drug|G-CSF|10 mcg/kg
16296550|NCT00669877|Drug|Cytarabine|100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
16296551|NCT00669877|Drug|Methotrexate|200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.
16296552|NCT00669864|Drug|biphasic insulin aspart 30|Subcutaneous (under the skin) injection, twice daily
16296553|NCT00669864|Drug|metformin|Tablets, 1000 - 2000 mg daily
16296554|NCT00669851|Drug|AI-700|
16296555|NCT00669825|Drug|ALV003|Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg
16296556|NCT00669825|Drug|Placebo|Placebo to be administered via intragastric tube
16296557|NCT00669812|Drug|carmustine|
16296558|NCT00669812|Drug|cyclophosphamide|
16296559|NCT00669812|Drug|cytarabine|
16296560|NCT00669812|Drug|doxorubicin hydrochloride|
16296561|NCT00669812|Drug|epirubicin hydrochloride|
16296562|NCT00669812|Drug|etoposide|
16296563|NCT00669812|Drug|ifosfamide|
16296564|NCT00669812|Drug|melphalan|
16296565|NCT00669812|Drug|methotrexate|
16296566|NCT00669812|Drug|prednisolone|
16296567|NCT00669812|Drug|vincristine sulfate|
16296568|NCT00669812|Procedure|autologous hematopoietic stem cell transplantation|
16296569|NCT00669812|Procedure|biopsy|
16296570|NCT00669812|Procedure|peripheral blood stem cell transplantation|
16296571|NCT00669799|Drug|gentamyacin|topical internasal
16296572|NCT00669799|Drug|gentamyacin|intranasal
16296573|NCT00669786|Drug|Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)|
16296574|NCT00669773|Drug|Adriamycin|Arm A: 4 cycles of adriamycin at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of docetaxel at 75mg/m2 3 weekly
16296575|NCT00669773|Drug|Docetaxel|Arm B: 4 cycles of docetaxel at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of adriamycin at 75mg/m2 3 weekly.
16296576|NCT00669760|Other|non-interventional study|does not apply
16296577|NCT00669747|Drug|Carboplatin i.d. Days 1 & 15|Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
16296578|NCT00669747|Drug|Carboplatin i.d. Day 1; Normal Saline i.d. Day 15|Carboplatin 10 mg/ml, 10 ml (100 mg) i.d. DCIS duct on Day 1 Normal Saline, 10 ml i.d. DCIS duct on Day 15
16296579|NCT00669747|Drug|Normal Saline|Normal Saline, 10 ml, i.d. on Days 1 and 15
16296584|NCT00669721|Drug|law molecular weigth heparin|administration of LMWH as anticoagulation for hemodialysis circuit;nadroparin is administred ad the dosage of 65 IU/kg on starting dialysis and in the arterial hemodialytic line after a washing phase with 2 litres of a heparin-free saline solution 0.9%.
16296585|NCT00669721|Drug|unfractioned heparin|administration of UFH as anticoagulation of hemodialysis circuit; standard heparin ( Sodic Heparin, Vister by Parke-Davis) 1500 IU on starting dialysis and 1500 ± 500 IU in continues intradialytic infusion per dialysis session
16296586|NCT00669708|Device|cooling compound (ph5 Eucerin)|application twice daily to the skin
16296587|NCT00669695|Drug|Atorvastatin treatment|Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
16296588|NCT00669695|Other|CPAP device|This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.
16296589|NCT00669695|Other|sham CPAP treatment|This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
16296590|NCT00669682|Other|Congestive heart failure|Spontaneous occurrence of fluid overload.
16296591|NCT00669669|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D conformal IMRT
16296592|NCT00669669|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous in vitro-treated peripheral blood stem cell transplant
16296593|NCT00669669|Drug|Carmustine|Given IV
16296594|NCT00669669|Biological|Filgrastim|Given SC
16296595|NCT00669669|Procedure|In Vitro-Treated Peripheral Blood Stem Cell Transplantation|Undergo autologous in vitro-treated peripheral blood stem cell transplant
16296596|NCT00669669|Radiation|Intensity-Modulated Radiation Therapy|Undergo 3D conformal IMRT
16296597|NCT00669669|Other|Laboratory Biomarker Analysis|Correlative studies
16296598|NCT00669669|Drug|O6-Benzylguanine|Given IV
16296599|NCT00669669|Drug|Plerixafor|Given SC
16296600|NCT00669669|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
16296601|NCT00669669|Drug|Temozolomide|Given PO
16296602|NCT00669656|Drug|Prostate Health Cocktail|3 capsules daily PO up 12 months
16296651|NCT00669292|Biological|URLC10-177, TTK-567, CpG-7909|peptide, peptide, TLR-9 agonist
16296603|NCT00669643|Drug|PB 6 doses - Rifampicin and Dapsone|"Adult: 6 doses;
~1 monthly supervised dose: 600 mg Rifampicin + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone;
~Children: 6 doses;
~1 monthly supervised dose: 450 mg Rifampicin + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone"
16296604|NCT00669643|Drug|PB 6 doses - Rifampicin, Clofazimine and Dapsone|"Adult: 6 doses;
~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;
~Children: 6 doses;
~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"
16296605|NCT00669643|Drug|MB 12 doses - Rifampicin, Clofazimine and Dapsone|"Adult: 12 doses;
~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;
~Children: 12 doses;
~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"
16296606|NCT00669643|Drug|MB 6 doses - Rifampicin, Clofazimine and Dapsone|"Adult: 6 doses
~1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine
~Children: 6 doses
~1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"
16296607|NCT00669630|Behavioral|Lay Health Promoter (LHP) with maintenance|Lay Health Promoters (LHPs) and their congregations will join an existing social and organizational support network, comprised of LHPs and congregations who are part of an active community health improvement collaborative.
16296608|NCT00669617|Drug|Indacaterol|Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
16296609|NCT00669617|Drug|Salmeterol/fluticasone (50/500 μg)|Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
16296610|NCT00669617|Drug|Salbutamol (200 µg)|Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
16296611|NCT00669617|Drug|Placebo to Indacaterol|Placebo to indacaterol delivered via SDDPI
16296612|NCT00669617|Drug|Placebo to Salmeterol/fluticasone|Placebo to salmeterol/fluticasone delivered via MDDPI
16296613|NCT00669617|Drug|Placebo to salbutamol|Placebo to salbutamol delivered via MDDPI
16296614|NCT00669591|Drug|Bavituximab|Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.
16296615|NCT00669578|Drug|CC-4047|CC-4047: taken orally each day in a 28 day cycle.
16296616|NCT00669565|Drug|Bavituximab|Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.
16296617|NCT00669552|Procedure|Percutaneous coronary intervention|PCI previously electively scheduled.
16296618|NCT00669526|Behavioral|BCBT|Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.
16296619|NCT00669526|Behavioral|SMHC referral|Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).
16296620|NCT00669513|Behavioral|Partial sleep deprivation|Partial sleep deprivation (less than 5 hours, but no less than 3 hours and 30 minutes)
16296621|NCT00669500|Behavioral|Lifestyle intervention|Alive!TM web-based, 12 week lifestyle intervention sent via NutritionQuest.
16296622|NCT00669487|Drug|AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP|Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72
16296623|NCT00669487|Drug|AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP|GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z
16296624|NCT00669487|Drug|AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP|GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72
16296625|NCT00669474|Procedure|Suction curettage|Suction curettage
16296626|NCT00669474|Drug|Treatment with Botox|Treatment with Botox
16296627|NCT00669461|Drug|Lubiprostone|Lubiprostone 24 mcg BID orally for 4 weeks
16296628|NCT00669448|Behavioral|Minfulness-based cognitive therapy|Mindfulness Based Cognitive Therapy (MBCT) is a group intervention that integrates elements from primarily Mindfulness-based Stress Reduction programme (MBSR)and cognitive therapy.The MBCT programme includes 2½ hours of training once a week for 8 weeks. In addition participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.
16296629|NCT00669435|Drug|Losartan + Simvastatin|"tablets; 50, 100 mg; od; 12 months
~tablets; 20 mg; od; 6 months"
16296630|NCT00669435|Drug|Amlodipine + Simvastatin|"tablets; 5, 10 mg; od; 12 months
~tablets; 20 mg; od; 6 months"
16296631|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of 10 mcg/kg IV
16296632|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of 100 mcg/kg IV
16296633|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of 200 mcg/kg IV
16296634|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of 25 mcg/kg IV
16296635|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of 50 mcg/kg IV
16296636|NCT00669409|Drug|PF-04383119 (tanezumab)|single dose of Placebo IV
16296637|NCT00669396|Drug|Copper T380 IUD|Copper T380 IUD
16296638|NCT00669396|Drug|levonorgestrel|1.5 mg
16296639|NCT00669383|Drug|betamethasone|12 mg IM q 24 hours x 2 doses
16296640|NCT00669383|Drug|placebo|Placebo IM q 24 hours x 2 doses
16296641|NCT00669370|Drug|docetaxel and capecitabine|biweekly docetaxel iv (50 mg/m2) on day 1 and 15 and capecitabine po 1250 mg/m2 x 2/day days 1-7 and 15-21, treatment cycle consisting of 21 days
16296642|NCT00669357|Device|Abiocor Implantable Replacement Heart|Replacement of heart
16296643|NCT00669344|Drug|Exelon (rivastigmine)|Capsules, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
16296644|NCT00669344|Drug|Placebo|Capsule, twice daily orally. Dosage starts at 1.5mg bis diem to 4.5mg bis diem.
16296645|NCT00669331|Drug|Inhaled mannitol|400mg dose of Mannitol BD (twice a day) for 52 weeks
16296646|NCT00669331|Drug|Matched control|50mg dose of Mannitol BD (twice a day) for 52 weeks
16296647|NCT00669318|Biological|alemtuzumab|
16296648|NCT00669318|Biological|rituximab|
16296649|NCT00669318|Drug|pentostatin|
16296652|NCT00669279|Drug|Carvedilol CR|Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks
16296653|NCT00669279|Drug|Atenolol|Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks
16296654|NCT00669253|Procedure|Er: YAG Laser|Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
16296655|NCT00669253|Procedure|Conventional treatment 1(ultrasonic and manual means)|Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means
16296656|NCT00669253|Procedure|Conventional treatment 2 (ultrasonic and manual means)|Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means
16296657|NCT00669240|Drug|Varenicline|According to the approved Summary of Product Characteristics (SmPC), patients will be required to orally take 0.5 mg once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4 - 7. From day 8 to the end of treatment patients should take 1 mg twice daily. Patients who cannot tolerate adverse effects of Champix may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should be treated for 12 weeks. Treatment should start 1 - 2 weeks prior to quitting smoking.
16296658|NCT00669227|Other|autologous stem cells|intracoronary administration at the same day of cell aspiration using the stop flow technique
16296659|NCT00669227|Other|placebo suspension|intracoronary administration at the same day as cell aspiration
16296660|NCT00669214|Drug|efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
16296661|NCT00669214|Drug|placebo|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
16296664|NCT00669162|Drug|Docetaxel|20mg/m2 IV weekly for 7 weeks
16296665|NCT00669162|Radiation|Radiation Therapy|66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx
16296666|NCT00669162|Drug|Casodex and Zoladex (or Lupron)|Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)
16296667|NCT00669149|Drug|clopidogrel + aspirin|
16296668|NCT00669149|Drug|heparin + clopidogrel + aspirin|
16296669|NCT00669149|Drug|enoxaparin + clopidogrel + aspirin|
16296670|NCT00669149|Drug|bivalirudin + clopidogrel + aspirin|
16296671|NCT00669136|Drug|AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost|AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
16296672|NCT00669123|Drug|Chondroitin sulphate|Chondroitin sulphate 800 mg/day
16296673|NCT00669123|Drug|Placebo|
16296674|NCT00669110|Drug|Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)|"tablet
~subjects randomly assigned to 10-200 mg/day by age group
~6 month treatment period(~182 days)"
16296675|NCT00669097|Drug|TKI258|
16296676|NCT00669071|Drug|Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%|Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
16296677|NCT00669071|Drug|Cetaphil® Moisturizing Cream as Inactive Control|Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
16296678|NCT00669058|Drug|Lactic acid (Dermacid)|
16296679|NCT00669032|Device|Hyaluronic acid|3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year
16296680|NCT00669032|Other|Placebo|3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year
16296681|NCT00669019|Drug|saracatinib|
16296682|NCT00668993|Behavioral|EFT - the Emotional Freedom technique|"EFT combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as psychological acupuncture. Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published"
16296683|NCT00668967|Drug|verapamil|240 mg extended release tablets once daily at bedtime for 28 days
16296684|NCT00668967|Drug|verapamil|240 mg extended release tablets once daily at bedtime for 28 days
16296685|NCT00668954|Dietary Supplement|Pomegranate Juice|Group A drinks 8 oz. pomegranate juice/day for 12 weeks
16296686|NCT00668954|Dietary Supplement|Placebo Juice|Group B drinks 8 oz. placebo juice/day for 12 weeks
16296687|NCT00668941|Drug|Teriparatide|Teriparatide will be given subcutaneously in 20-mcg doses either continuously or cyclically.
16296688|NCT00668941|Drug|Alendronate|Participants will take 70 mg per week of alendronate for 48 months.
16296689|NCT00668941|Dietary Supplement|Calcium|Calcium supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily calcium intake to 1,200 mg.
16296690|NCT00668941|Dietary Supplement|Vitamin D3|Vitamin D3 supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily intake to 1,200 mg.
16296691|NCT00668928|Other|Polyphenols (flavon-3-ol monomers and oligomers)|Flavanols
16296692|NCT00668902|Drug|[13C]Pantoprazole|[13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes
16296693|NCT00668889|Drug|Lactic acid (Dermacid)|
16296694|NCT00668876|Dietary Supplement|Oral IMPACT|oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
16296695|NCT00668876|Dietary Supplement|Oral IMPACT|postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
16296696|NCT00668876|Dietary Supplement|Parenteral nutrition|Parenteral nutrition
16296697|NCT00668863|Drug|FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)|FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16296698|NCT00668863|Drug|Sunitinib|37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
16296699|NCT00668850|Drug|Generex Oral-lyn™|Generex Oral-lyn™ spray in a split-dose fashion (half the dose immediately prior to the meal and half the dose immediately after the meal) + BID NPH insulin AM and PM as pre-randomization dose
16296700|NCT00668850|Drug|Regular human insulin|Regular human insulin 30 minutes before meals + BID NPH insulin AM and PM as pre-randomization dose.
16296701|NCT00668837|Drug|Paliperidone|
16296702|NCT00668824|Drug|Vasovist|
16296703|NCT00668811|Drug|SU011248, Sutent|Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
16296704|NCT00668785|Drug|ranibizumab|Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
16296705|NCT00668772|Drug|Tiotropium/Salmeterol|Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
16296706|NCT00668772|Drug|Tiotropium/Salmeterol QD + Salmeterol|Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
16296707|NCT00668772|Drug|Placebo|Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
16296708|NCT00668772|Drug|Salmeterol|Salmeterol Inhalation Powder, hard PE capsule
16296709|NCT00668772|Drug|Tiotropium|Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
16296710|NCT00668759|Drug|Vernakalant Injection|10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).
16296711|NCT00668759|Drug|Amiodarone Injection:|60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).
16296712|NCT00668746|Drug|Minocycline HCl microspheres|At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.
16296713|NCT00668720|Device|transcranial magnetic stimulation (Magstim rapid2)|Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.
16296714|NCT00668720|Device|sham stimulation|The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days
16296715|NCT00668707|Dietary Supplement|melatonin|20 mgs ingested nightly
16296716|NCT00668707|Dietary Supplement|placebo|similar to experimental in all ways except for lack of active ingredient
16296717|NCT00668694|Behavioral|Stimulation|Stimulation given to the child by mother
16296718|NCT00668681|Device|EndoRefix|
16296719|NCT00668668|Drug|Lactic acid (Dermacid)|
16296720|NCT00668655|Drug|Metronidazole Gel|Topical, Once daily for 2 weeks
16296721|NCT00668642|Drug|Dutasteride|0.5 mg capsule given orally on daily basis
16296722|NCT00668642|Drug|Placebo|Identical placebo
16296723|NCT00668629|Drug|Lactic acid (Dermacid)|
16296724|NCT00668616|Drug|Cyclophosphamide, Epirubicin, Paclitaxel|4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d
16296725|NCT00668616|Drug|Epirubicin, Paclitaxel, Filgrastim|cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)
16296726|NCT00668603|Drug|17-b-estradiol|2mg oral daily for 6 months
16296727|NCT00668603|Drug|17-b-estradiol + medroxyprogeterone acetate|2mg E2 + 5mg MPA daily for 6 months
16296728|NCT00668603|Drug|17-b-estradiol hemihydrate|1 mg skin gel daily for 6 months
16296729|NCT00668603|Drug|placebo pill + gel|placebo daily for 6 months
16296730|NCT00668590|Behavioral|Patient video decision aid & telephone coaching|The decision aid is a 30 minute video program that educates patients about their role in diabetes care. Telephone coaching will assist patients in initiating behavior change.
16296731|NCT00668590|Behavioral|Printed educational brochure|The printed brochure is an educational brochure developed by the NIH.
16296732|NCT00668577|Drug|Lactic acid (Dermacid)|
16296733|NCT00668564|Procedure|Stem Cell Transplantation|The purpose of hematopoietic stem cell transplantation is to introduce blood producing cells from a normal donor. These cells can either provide what is missing in the body to the other cells, or can change the body's immune response to the substances that have accumulated in the body. These normal hematopoietic stem cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e., blood taken from the umbilical cord after a baby is born and umbilical cord is cut). The new donor cells repopulate the blood and bone marrow system and enter the organs of the body, including the brain. Wherever these cells go, they will produce the needed enzyme.
16296734|NCT00668564|Drug|Cyclophosphamide|"Days before Transplant Drug Frequency
~4 Cyclophosphamide Once, given over 2 hours
~3 Cyclophosphamide Once, given over 2 hours
~2 Cyclophosphamide Once, given over 2 hours
~1 Cyclophosphamide Once, given over 2 hours"
16296839|NCT00667810|Drug|bapineuzumab|Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
16296735|NCT00668564|Drug|Campath-1H|"Days before Transplant Drug Frequency
~12 Campath-1H Once, given over 2 hours
~11 Campath-1H Once, given over 2 hours
~10 Campath-1H Once, given over 2 hours"
16296736|NCT00668564|Drug|Busulfan|"Days before Transplant Drug Frequency
~9 Busulfan Four times per day
~8 Busulfan Four times per day
~7 Busulfan Four times per day
~6 Busulfan Four times per day"
16296737|NCT00668538|Drug|Brentan (miconazole)|Vaginal suppository 1200 mg at day 6
16296738|NCT00668525|Drug|Escitalopram|Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
16296739|NCT00668525|Drug|Placebo|Placebo, oral administration, once daily dosing for 8 weeks
16296740|NCT00668525|Drug|Escitalopram|Escitalopram high dose, oral administration, once daily dosing for 8 weeks
16296741|NCT00668512|Biological|Antimelanoma injection of GSL alpha-Gal|Single arm, phase 1 trial of escalating doses of GSL alpha-Gal (0.1mg, 1mg, 10mg)injected into a melanoma metastasis at day 0 and then again 4 weeks later.
16296742|NCT00668499|Drug|VEGF-Antisense Oligonucleotide , Pemetrexed, Cisplatin|VEGF-AS either 100 or 200mg/m2 IV days 1-5, Pemetrexed 500mg/m2 and Cisplatin 75mg/m2 IV on day 1. Cycle repeated every 3 weeks until 6 cycles completed, unless PD or toxicities
16296743|NCT00668486|Drug|Lactic acid (Dermacid)|
16296744|NCT00668460|Drug|Lactic acid (Dermacid)|
16296745|NCT00668447|Dietary Supplement|Soy Isolate|20 grams of powder mixed in beverages or food daily for one year
16296746|NCT00668447|Dietary Supplement|Control protein|20 grams of powder mixed in beverages or food daily for one year
16296747|NCT00668447|Dietary Supplement|Novasoy isoflavones|3 tablets daily for one year
16296748|NCT00668447|Dietary Supplement|Placebo tablets|3 tablets daily for one year
16296749|NCT00668434|Drug|Prednisone|For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
16296750|NCT00668434|Drug|Placebo|Placebo capsules will look the same as the study medication but will not contain active medicine.
16296751|NCT00668421|Drug|CEP-701 (Lestaurtinib)|Lestaurtinib (CEP-701), oral formulation. Phase 1: 80 BID - 160 BID; phase 2: 140 mg
16296752|NCT00668408|Other|LTOT (oxygen therapy)|Patients on LTOT will receive oxygen for at least 15 hours/day from the liquid oxygen systems at a flow rate adjusted to raise resting SaO2 between 93 and 96% and / or PaO2 between 65 and 80 mmHg every day for 3 years.
16296753|NCT00668408|Other|Pharmacological therapy of COPD and CHF|"Optimal pharmacologic treatment will include :
~Long (LABD, salmeterol, formoterol, tiotropium) - as well as short-acting (SABD, Salbutamol, terbutaline, ipratropium)bronchodilators (beta-2 agonists, anticholinergics)
~Inhaled steroids (ICS, beclomethasone, fluticasone, budesonide always associated with LABD)
~Beta-blockers
~Diuretics
~Angiotensin-converting enzyme (ACE) inhibitors alone or in associations with diuretics
~Statins and any other treatment required for associated co-morbidities (eg insulin and/or anti-diabetic drugs, other antihypertensive, etc).
~The treatment of the deseases will follow the international guidelines."
16296754|NCT00668395|Drug|Efavirenz|The metabolism and pharmacokinetics of efavirenz were assessed at a single 600 mg oral dose of efavirenz and after subjects took multiple doses of efavirenz (600 mg/day orally for 17 days).
16296755|NCT00668382|Biological|Alpha-Gal Glycosphingolipid|Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity
16296756|NCT00668369|Procedure|Gradual immunosuppression drug withdrawal.|Ater obtention of biological samples (peripheral blood, liver tissue) enrolled patients undergo gradual decrease in the doses of immunosuppression drugs (tacrolimus, cyclosporine A and/or mofetil mycophenolate) until complete discontinuation or appearance of rejection.
16296757|NCT00668356|Drug|didanosine|28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting
16296758|NCT00668356|Drug|didanosine|28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal
16296759|NCT00668343|Drug|simvastatin|40 mg/ day
16296760|NCT00668343|Drug|placebo|80 mg /day
16296761|NCT00668330|Drug|Ibandronate+alfacalcidol+calcium|Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium
16296762|NCT00668330|Drug|placebo ibandronate+alfacalcidol+calcium|placebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium
16296763|NCT00668317|Drug|Omeprazole|20 mg BD tablet 8 weeks duration
16296764|NCT00668317|Drug|Ranitidine|300 mg od nocte tablet 8weeks duration
16296765|NCT00668304|Drug|Avelox (Moxifloxacin, BAY12-8039)|Moxifloxacin 400 mg once orally daily
16296766|NCT00668278|Device|Insertion of laryngeal mask airway (AuraOnce mask)|Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask
16296767|NCT00668278|Device|Insertion of I-gel airway|Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg
16296768|NCT00668278|Other|Measurement of airway pressures|Measurement of peak airway pressure under steady state; measurement of device seal pressure
16296769|NCT00668265|Drug|Quetiapine|Dosage is 50 - 300 mg, once daily, at bedtime.
16296770|NCT00668239|Drug|intravitreous triamcinolone|Intravenous injection of 0.1 ml (4 mg) of triamcinolone acetate was performed through the pars plana in a surgical environment. The medication used was manipulated by the Ophthalmos chemist. This type of formulation is different from the similar American one (Kenalog ®) since it does not use a conservation agent
16296771|NCT00668239|Procedure|laser therapy|pan fotocoaglulation by laser therapy
16296772|NCT00668226|Drug|Lactic acid (Dermacid)|
16296773|NCT00668200|Drug|Reclast (ZOL446, zoledronic acid)|"5 mg i.v. annually (real-life, physician prescribed)"
16296774|NCT00668200|Dietary Supplement|Calcium|1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
16296775|NCT00668200|Dietary Supplement|Vitamin D|800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
16296776|NCT00668174|Behavioral|Exercise|Moderate intensity exercise, 5 days per week, 45 min per session, 50-70% max HR, divided into a 3-month individualized and 9-month maintenance period.
16296777|NCT00668161|Behavioral|Exercise|60 minutes/session of aerobic exercise, 6 d/week at 50-50% HHR. All sessions will begin with 10 minutes of stretching and 5 minutes of warm-up, and will end with 5 minutes of cool down.
16297125|NCT00666172|Behavioral|Weight Loss|
16296778|NCT00668148|Biological|IMC-A12 (cixutumumab)|"Ewing's Sarcoma/PNET
~10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every two weeks.
~A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle."
16296779|NCT00668148|Biological|IMC-A12 (cixutumumab)|"Rhabdomyosarcoma
~10 mg/kg IV infusion every two weeks.
~A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle."
16296780|NCT00668148|Biological|IMC-A12 (cixutumumab)|"Leiomyosarcoma
~10 mg/kg IV infusion every two weeks.
~A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle."
16296781|NCT00668148|Biological|IMC-A12 (cixutumumab)|"Adipocytic sarcoma
~10 mg/kg IV infusion every two weeks.
~A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle."
16296782|NCT00668148|Biological|IMC-A12 (cixutumumab)|"Synovial sarcoma
~10 mg/kg IV infusion every two weeks.
~A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle."
16296783|NCT00668135|Drug|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg orally on demand prior to intercourse
16296784|NCT00668135|Drug|Placebo|Matching placebo
16296785|NCT00668122|Drug|Cipro XR (Ciprofloxacin, BAYQ3939)|Ciprofloxacin XR 1000 mg orally once a day
16296786|NCT00668122|Drug|Cipro IR (Ciprofloxacin, BAYQ3939)|Ciprofloxacin IR 500 mg orally twice a day
16296787|NCT00668109|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg one hour prior to sexual intercourse
16296788|NCT00668109|Drug|Tadalafil|10 mg taken approximately 24 hours prior to sexual intercourse
16296789|NCT00668096|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
16296790|NCT00668096|Drug|Placebo|Matching Placebo
16296791|NCT00668070|Drug|ASP9831|Oral
16296792|NCT00668070|Drug|Placebo|Oral
16296793|NCT00668057|Drug|Levitra (Vardenafil, BAY38-9456)|5 mg Vardenafil orally 1 hour prior to sexual intercourse
16296794|NCT00668057|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg Vardenafil orally 1 hour prior to sexual intercourse
16296795|NCT00668057|Drug|Levitra (Vardenafil, BAY38-9456)|20 mg Vardenafil orally 1 hour prior to sexual intercourse
16296796|NCT00668057|Drug|Placebo|5 mg matching placebo
16296797|NCT00668057|Drug|Placebo|10 mg matching placebo
16296798|NCT00668057|Drug|Placebo|20 mg matching placebo
16296799|NCT00668044|Drug|Ciprofloxacin (BAYO9867)|400 mg iv BID
16296800|NCT00668044|Drug|Ciprofloxacin (BAYO9867)|400 mg iv TID
16296801|NCT00668031|Drug|Trasylol (Aprotinin, BAYA0128)|A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
16296802|NCT00668031|Drug|Placebo|A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump
16296803|NCT00668018|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10mg orally on demand prior to intercourse
16296804|NCT00668005|Drug|Levitra (Vardenafil, BAY38-9456)|5mg, 10mg or 20mg taken 1h before sexual intercourse
16296805|NCT00668005|Drug|Placebo|Matching placebo
16296806|NCT00667992|Drug|Budesonide HFA|standard daily inhaled dose
16296807|NCT00667992|Drug|Budesonide CFC|standard daily inhaled dose
16296808|NCT00667979|Drug|Levitra (Vardenafil, BAY38-9456)|10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse
16296809|NCT00667979|Drug|Placebo|Matching placebo
16296810|NCT00667966|Drug|Vardenafil (Levitra, BAY 38-9456), 10 mg|10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
16296811|NCT00667966|Drug|Placebo|10/20 mg placebo in sequence in respective arm
16296812|NCT00667966|Drug|Vardenafil (Levitra, BAY 38-9456), 20 mg|20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
16296813|NCT00667953|Drug|Gleevec + Temozolomide|Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
16296814|NCT00667940|Behavioral|Rater training workshop|Rater training workshop: rater error training, performance dimension training, behavioral observation training, and frame of reference training using lecture, video, and facilitated discussion
16296815|NCT00667927|Drug|Busulfan|See Detailed Description section for description of treatment plan.
16296816|NCT00667927|Drug|Cyclophosphamide|See Detailed Description section for description of treatment plan.
16296817|NCT00667927|Drug|Mesna|See Detailed Description section for description of treatment plan.
16296818|NCT00667914|Procedure|geriatric work-up|Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
16296819|NCT00667914|Procedure|Orthopedic care as usual|treatment in ordinary orthopedic unit
16296820|NCT00667901|Drug|riluzole|
16296821|NCT00667901|Genetic|protein expression analysis|
16296822|NCT00667901|Genetic|reverse transcriptase-polymerase chain reaction|
16296823|NCT00667901|Genetic|western blotting|
16296824|NCT00667901|Other|immunohistochemistry staining method|
16296825|NCT00667901|Other|laboratory biomarker analysis|
16296826|NCT00667901|Other|pharmacological study|
16296827|NCT00667901|Procedure|neoadjuvant therapy|
16296828|NCT00667901|Procedure|therapeutic conventional surgery|
16296829|NCT00667888|Radiation|Conventional Fractionated Intensity Modulated Radiotherapy|A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
16296830|NCT00667888|Radiation|Hypofractionated Intensity Modulated Radiotherapy|A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
16296831|NCT00667875|Drug|Placebo|placebo
16296832|NCT00667875|Drug|Naltrexone|Naltrexone (25mg or 50 mg per titration schedule)
16296833|NCT00667875|Drug|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
16296834|NCT00667862|Drug|Panobinostat|
16296835|NCT00667849|Device|Exogen 4000+|Low-intensity pulsed ultrasound (LIPUS)
16296836|NCT00667849|Device|Sham|sham device identical to active device with the exception of administration of ultrasound
16296837|NCT00667823|Drug|Macitentan|Tablet, oral administration, 10 mg dose once daily
16296838|NCT00667810|Drug|bapineuzumab|Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
16296840|NCT00667810|Drug|placebo|Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
16296841|NCT00667797|Drug|levalbuterol HCl|Levalbuterol 1.25 mg will be prescribed every 6-8 hours, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of levalbuterol administration at their discretion.
16296842|NCT00667797|Drug|albuterol Sulfate|Racemic albuterol 2.5 mg will be prescribed per the standard of care used in the institution, with standing orders for as needed PRN use. However, the prescribing physician may change the dose, frequency, and/or duration of racemic albuterol administration at their discretion.
16296843|NCT00667784|Behavioral|Questionnaire|Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.
16296844|NCT00667771|Drug|Naltrexone|
16296845|NCT00667758|Drug|Cetrorelix|3-5 mg s.c. on days 1-5
16296846|NCT00667758|Drug|Placebo|3-5 ml NaCl s.c. on days 1-5
16296847|NCT00667745|Drug|Lithium Carbonate|Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.
16296848|NCT00667745|Drug|Optimized Treatment (OPT)|The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.
16296849|NCT00667732|Drug|exenatide|5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
16296850|NCT00667732|Drug|placebo|5mcg twice a day, increased to 10mcg twice a day for 24 weeks
16296851|NCT00667719|Drug|Aliskiren|300 mg tablet
16296852|NCT00667719|Drug|Amlodipine|5 mg tablet
16296853|NCT00667719|Drug|Hydrochlorothiazide|12.5 mg and 25 mg capsule
16296854|NCT00667706|Procedure|laparoscopic operation Sleeve Gastrectomy|Laparoscopic Sleeve Gastrectomy will be performed employing a 5-6 trocar technique, and includes gastric resection starting 4-5 cm proximal to the pylorus, using a 38 fr. Bougie and endoscopic stapler with blue and green load.
16296855|NCT00667706|Procedure|laparoscopic operation Roux-en-Y Gastric bypass|Divided LRYGB will employ 5-7 trocars technique, and includes stapled jejunojejunostomy 30-50 cm distal to the Treitz ligament, gastric pouch of 20 cc., and antecolic, antegastric gastrojejunal anastomosis, either two layered hand-sawn, GIA, or EEA-25 -stapled, at surgeons preference. The length of the Roux limb will be 100 centimeters or 150 centimeters in patients with BMI of <50, and >50, respectively.
16296856|NCT00667693|Device|Macintosh laryngoscope|Intubation with Macintosh laryngoscope
16296857|NCT00667693|Device|Pentax AWS|Intubation with Pentax AWS
16296858|NCT00667680|Device|Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator|real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
16296859|NCT00667667|Device|vertical vibration device (Vibrafit whole body vibration platform)|3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device
16296860|NCT00667667|Device|side alternating vibration device (Board 3000 whole body vibration platform)|3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device
16296861|NCT00667667|Behavioral|stretching and wellness (control group)|2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months
16296862|NCT00667654|Drug|CNTX-4975|Testing a range of dosing configurations to optimize patient tolerability
16296863|NCT00667641|Drug|bortezomib|Starting dose level 0.70mg/m2
16296864|NCT00667641|Drug|paclitaxel|Starting dose level 40mg/m2
16296865|NCT00667628|Drug|TAC-101|Patients will receive TAC-101 20 mg (2 x 10-mg formulated tablets) administered orally every day with approximately 8 oz. water within 1 hour following a morning meal for 14 days followed by a 7-day recovery period, repeated every 21 days.
16296866|NCT00667628|Drug|Placebo|Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment
16296867|NCT00667615|Drug|rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks. Quality of life determinations will be obtained at the beginning of each cycle of chemotherapy and at each visit during the first year of followup.
16296868|NCT00667602|Biological|MenACWY-CRM197 (two doses)|Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
16296869|NCT00667602|Biological|MenC|One 0.5mL dose of MenC vaccine was administered by intramuscular injection.
16296870|NCT00667602|Biological|PCV7|One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
16296871|NCT00667602|Biological|DTPa-IPV-HepB-Hib|One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
16296872|NCT00667602|Biological|MenACWY-CRM197 (one dose)|One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
16296873|NCT00667589|Drug|urea 40% cream|urea 40% cream applied twice per day to affected areas
16296874|NCT00667589|Drug|fluocinonide 0.05% cream|fluocinonide 0.05% cream applied twice per day to affected areas
16296875|NCT00667589|Drug|tazarotene 0.1% cream|tazarotene 0.1% cream applied twice per day to affected areas
16296876|NCT00667589|Drug|bland emollient cream (Udderly smooth® Udder Cream)|bland emollient cream applied twice per day to affected areas
16296877|NCT00667576|Drug|Maxacalcitol|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.
16296878|NCT00667576|Drug|Paricalcitol|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.
16296879|NCT00667563|Biological|quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
16296880|NCT00667563|Genetic|DNA analysis|Weeks 0, 2, 10, 26, and 52.
16296881|NCT00667563|Genetic|polymerase chain reaction|Screening, week 36, and week 52.
16296882|NCT00667563|Other|cytology specimen collection procedure|Screening, week 36, and week 52.
16296883|NCT00667563|Procedure|colposcopic biopsy|Screening, week 36, and week 52.
16296884|NCT00667537|Drug|Radium-223 chloride (Xofigo®, BAY88-8223) injection|Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration
16296885|NCT00667511|Device|NxStage System One|Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
16296886|NCT00667498|Drug|Metformin|"The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.
~The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia."
16296887|NCT00667498|Drug|Placebo|"The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.
~The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia."
16296888|NCT00667485|Drug|Rapamycin (liquid)|Weekly Rapamycin (liquid) 90mg (dose will be split 45mg on Day 1 and Day 2 of each week)
16296889|NCT00667485|Drug|Bevacizumab|Multiple doses (dose depends on time of study entry) given by IV once every 3 weeks
16296890|NCT00667485|Drug|Rapamycin (Tablets)|Daily oral rapamycin (tablets) - 2 doses will be tested 4mg and 6mg
16296891|NCT00667472|Drug|Ranibizumab|Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
16296892|NCT00667472|Device|Pulsed Dye Laser|Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
16296893|NCT00667459|Device|PRESTIGE® LP Cervical Disc|The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
16296894|NCT00667459|Device|ATLANTIS Anterior Cervical Plate|Anterior cervical discectomy and fusion with ATLANTIS plate for control group
16296895|NCT00667446|Drug|Leuprolide Acetate 3 Month Depot|
16296896|NCT00667433|Drug|Raltegravir + Truvada|Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks
16296897|NCT00667420|Drug|panitumumab, epirubicin, oxaliplatin, xeloda|pilot study
16296898|NCT00667407|Drug|Levalbuterol 1.25 mg|"levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated.
~Period II: TID for 3 days (same time of day), then PRN to TID for 7 days"
16296899|NCT00667407|Drug|Racemic Albuterol Sulfate|"Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated.
~Period II: TID for 3 days then PRN to TID for 7 days"
16296900|NCT00667394|Biological|Bevacizumab|Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
16296901|NCT00667394|Drug|MLN-518 (Tandutinib)|Tandutinib 500 mg by mouth daily dose twice a day.
16296902|NCT00667394|Procedure|Quality-of-life assessment|Forty-five one-sentence questionnaire to assess health related quality of life in patients with brain cancer.
16296903|NCT00667381|Device|Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)|Real-time ultrasound guidance will be used to aid in femoral artery cannulation. This will occur with a 7 MHz ultrasound probe covered with a sterile cover.
16296904|NCT00667368|Drug|Metronidazole|Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
16296905|NCT00667355|Biological|adalimumab|40 mg or 80 mg every other week, subcutaneous
16296906|NCT00667342|Biological|Bevacizumab|Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
16296907|NCT00667342|Drug|Cisplatin|Given IV.
16296908|NCT00667342|Drug|Doxorubicin|Given IV.
16296909|NCT00667342|Drug|Methotrexate|Given IV.
16296910|NCT00667342|Drug|Ifosfamide|Given IV.
16296911|NCT00667342|Drug|etoposide|Given IV.
16296912|NCT00667342|Procedure|Surgery|Participants undergo definitive surgery and assessment of histologic response at week 10.
16296913|NCT00667342|Radiation|Radiotherapy|Radiation therapy delivered for positive margins or intralesional resections.
16296914|NCT00667329|Drug|2CdA|1.5 mg/m^2 subcutaneous injection three times daily x 7 days.
16296915|NCT00667329|Drug|Cyclophosphamide|40 mg/m^2 PO twice daily x 7 days.
16296916|NCT00667329|Drug|Rituximab|375 mg/m^2 IV once weekly x 4 weeks.
16296917|NCT00667316|Behavioral|Set of questionnaires (respondent)|A set of questionnaires to determine risk factors for sick leave due to low back pain.
16296918|NCT00667303|Other|Nasopharyngeal Washes|A total of eight nasopharyngeal washes will be done at the following time points: Prior to conditioning, on the day of admission and thereafter every two weeks until day +100 (Day +14, 28, 42, 56, 70, 84 and 98). To allow for flexibility over the weekends and holidays the specimen may be collected on the scheduled day ± 3 days. The baseline sample obtained prior to conditioning is required for patient to be considered evaluable.
16296919|NCT00667303|Other|Fluorescent antibody detection|For IF (Direct IF for hHRSV and indirect IF for the other viruses), the specimens will be spotted onto glass slides. Samples without respiratory epithelial cells will be considered inconclusive. Labelled antibodies against Flu A, Flu B, HPIV 1 to 3, RSV, hMPV and Adv will be used.
16296920|NCT00667303|Other|Respiratory viral culture|Shell vial culture specimens will be inoculated and incubated for 48 hours. The following RVs: Flu A, Flu B, HPIV 1-3, RSV, Adv and hMPV will be identified on the basis of cytopathic effects in cell cultures and confirmed by staining with fluorescein-conjugated monoclonal antibodies.
16296921|NCT00667290|Behavioral|Treadmill exercise|Graded treadmill walking 3 times per week for 3 months
16296922|NCT00667277|Drug|bevacizumab (Avastin)|15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
16296923|NCT00667264|Procedure|perineural ropivacaine|Subjects will be randomized to one of two groups: ropivacaine 0.4% or normal saline (placebo). The basal rate will be set at 7 mL/h.
16296924|NCT00667251|Biological|trastuzumab|IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
16296925|NCT00667251|Drug|docetaxel|75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
16296926|NCT00667251|Drug|lapatinib ditosylate|1250 mg po daily (while given with taxane). 1500mg PO daily (when given alone after taxane completion).
16296927|NCT00667251|Drug|paclitaxel|80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.
16296928|NCT00667238|Behavioral|Questionnaire|
16296929|NCT00667225|Drug|cantharidin's vehicle|Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.
16296930|NCT00667225|Drug|Cantharidin 0.7%|Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.
16296931|NCT00667212|Behavioral|Cognitive Behavioral Therapy|Twelve weekly therapy sessions, approximately one hour each in duration
16296932|NCT00667212|Behavioral|Supportive Psychotherapy|Twelve weekly therapy sessions, approximately one hour each in duration
16296933|NCT00667199|Drug|Radium-223 dichloride (BAY88-8223)|The required volume of study drug to be administered to a patient was calculated using the patient's body weight, the dose (5 , 25 , 50 or 100 kBq/kg b.w.)
16296934|NCT00667186|Other|Targeted Screening|Selection method for screening is based on risk
16296935|NCT00667186|Other|Routine Screening|Selection method for screening is not based on risk
16296936|NCT00667173|Drug|IDP-115|Topical application for 12 weeks
16296937|NCT00667173|Drug|Vehicle|Topical application for 12 weeks
16296938|NCT00667173|Drug|Vehicle|Topical application for 12 weeks
16296939|NCT00667160|Drug|tacrolimus ointment|topical
16296940|NCT00667160|Drug|pimecrolimus cream|topical
16296941|NCT00667147|Drug|Weekly Abraxane and Daily Vandetanib|Abraxane once a week for three weeks, followed by one week with no Abraxane. Vandetanib once a day every day for 28 days. This four week period is called a cycle.
16296942|NCT00667147|Drug|Abraxane every three weeks and daily vandetanib|Abraxane on day one of study therapy, followed by 20 days of no Abraxane. Vandetanib once a day every day for 21 days. This three week period is called a cycle.
16296943|NCT00667121|Drug|citalopram hydrobromide|
16296944|NCT00667121|Drug|escitalopram oxalate|
16296945|NCT00667121|Drug|gabapentin|
16296946|NCT00667121|Drug|sertraline hydrochloride|
16296947|NCT00667121|Drug|tamoxifen citrate|
16296948|NCT00667121|Drug|venlafaxine|
16296949|NCT00667121|Genetic|molecular genetic technique|
16296950|NCT00667121|Other|high performance liquid chromatography|
16296951|NCT00667121|Other|laboratory biomarker analysis|
16296952|NCT00667121|Other|pharmacological study|
16296953|NCT00667121|Procedure|adjuvant therapy|
16296954|NCT00667108|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
16296955|NCT00667108|Drug|Gabapentin|Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
16296956|NCT00667108|Drug|Placebo|Matched placebo 30 minutes prior to bedtime
16296957|NCT00667095|Drug|Botox Instillation|Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
16296958|NCT00667095|Drug|DMSO Instillation|DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
16296959|NCT00667082|Drug|NPI-0052 (marizomib) + vorinostat|"NPI-0052 IV injection over 1 to 10 minutes at doses ranging from 0.15 to 0.7 mg/m2 on Days 1, 8, and 15 of each 28-day Cycle
~Oral vorinostat 300 mg was administered with food on Days 1 to 16 of each 28-day Cycle"
16296960|NCT00667069|Drug|triptorelin|
16296961|NCT00667069|Procedure|adjuvant therapy|
16296962|NCT00667069|Radiation|3-dimensional conformal radiation therapy|
16296963|NCT00667056|Drug|tacrolimus ointment|topical
16296964|NCT00667056|Drug|placebo ointment|topical
16296965|NCT00667043|Drug|remifentanil and propofol|Patients will receive: propofol, continuous intravenous infusion, concentration 10 mg/ml, 1-4 mg/kg/hour and remifentanil; continuous intravenous infusion 0,050 mg/ml, 0.1-0.3 microgram/kg/min. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
16296966|NCT00667043|Drug|fentanyl and midazolam|Patients will receive: midazolam; continuous intravenous infusion, concentration 5 mg/ml, 2-10 mg/hour and fentanyl; continuous intravenous infusion, concentration 0,050 mg/ml, 0.025-0.5 mg/hour. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
16296967|NCT00667030|Behavioral|Weight loss and aerobic exercise training|Weight loss and aerobic exercise training
16296968|NCT00667017|Biological|RFT5-dgA immunotoxin|
16296969|NCT00667017|Other|fluorescence activated cell sorting|
16296970|NCT00667017|Other|immunohistochemistry staining method|
16296971|NCT00667004|Drug|ecabet ophthalmic solution|sterile ophthalmic solution
16296972|NCT00667004|Drug|placebo|sterile ophthalmic solution
16296973|NCT00666991|Drug|nanoparticulate paclitaxel|This is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2.
16296974|NCT00666978|Behavioral|smoking cessation intervention|
16296975|NCT00666978|Drug|bupropion hydrochloride|
16296976|NCT00666978|Genetic|gene expression analysis|
16296977|NCT00666978|Genetic|polymerase chain reaction|
16296978|NCT00666978|Other|counseling intervention|
16296979|NCT00666978|Other|educational intervention|
16296980|NCT00666978|Procedure|psychosocial assessment and care|
16296981|NCT00666965|Drug|SPM 962|transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
16296982|NCT00666952|Other|Video Decision Aid|Participants randomized to the video decision aid group will be asked to view the video portion of the decision aid, Weight loss surgery: Is it right for you? in a private room The content of the video and accompanying booklet was based on a systematic-review of the efficacy and safety of bariatric surgery, input from experts in bariatric surgery, internal medicine, psychology, nutrition, and nursing, and from a series of focus groups and interviews with 30 morbidly obese patients, some of whom had elected not to have bariatric surgery.
16296983|NCT00666952|Other|Booklet Decision Aid|General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.
16296984|NCT00666939|Drug|Gabapentin|Gabapentin 100 mg oral capsule 30 minutes prior to bedtime
16296985|NCT00666939|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
16296986|NCT00666939|Drug|Placebo|Matched placebo 30 minutes prior to bedtime
16296987|NCT00666926|Drug|PF00562271|125 mg twice daily [BID] with food, tablet
16296988|NCT00666926|Drug|PF00562271|125 mg BID with food, tablet
16296989|NCT00666926|Drug|PF00562271|125 mg BID with food, tablet
16296990|NCT00666926|Drug|PF00562271|125 mg BID with food, tablet
16296991|NCT00666913|Other|informational intervention|Data from an archived database of a closed clinical trial is retrieved.
16296992|NCT00666900|Drug|Low Strength IDP-107|Once a day for 12 weeks
16296993|NCT00666900|Drug|High Strength IDP-107|Once a day for 12 weeks
16296994|NCT00666900|Drug|Placebo Comparator|Once a day for 12 weeks
16296995|NCT00666887|Drug|Minocycline|100 mg twice daily to be taken for up to 2 years
16296996|NCT00666887|Drug|Placebo|placebo twice daily for 2 years
16296997|NCT00666874|Behavioral|lifestyle changes|Detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity.
16296998|NCT00666874|Behavioral|Control - general information|General information about healthy food choices and exercise
16296999|NCT00666848|Drug|Placebo|Enalapril 0mg after 5 days of placebo versus after 5 days sitagliptin 100mg/d
16297000|NCT00666848|Drug|Enalapril 5mg|Enalapril 5 mg after 5 days placebo versus after 5 days sitagliptin 100mg/d
16297001|NCT00666848|Drug|Enalapril 10mg|Enalapril 10mg after 5 days placebo versus after 5 days sitagliptin 100 mg/d
16297002|NCT00666848|Drug|Sitagliptin|Sitagliptin 100mg/day for 5 days crossed over to placebo daily for 5 days prior to arms.
16297003|NCT00666835|Drug|HX575 epoetin alfa Hexal AG|HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
16297004|NCT00666835|Drug|ERYPO®, Janssen-Cilag|Solution for i.v. injection
16297005|NCT00666822|Behavioral|compliance monitoring|To examine the relationship between adherence to endocrine therapy and variables from the Health Belief Model (i.e., perceived risk, barriers to and benefits of adherence, and cues to action such as physician recommendation) as well as measures of patient's perceptions of patient- and family-centered care in women with estrogen receptor-positive stage I-IIIA breast cancer.
16297006|NCT00666822|Other|medical chart review|Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
16297007|NCT00666822|Other|questionnaire administration|Patients complete a 15 minute questionnaire on-line or by mail comprising questions of demographic and medical variables (i.e., age, race/ethnicity, marital and educational status, and medication side effects) as well as health beliefs and selected aspects of patient- and family-centered care. Data collected from the questionnaire will be stored in an Excel database.
16297008|NCT00666809|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
16297009|NCT00666809|Drug|Placebo|Placebo BID p.o. for 12 weeks + 4 weeks follow-up
16297010|NCT00666796|Drug|Placebo ethanol|Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
16297011|NCT00666796|Drug|Ethanol|Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
16297012|NCT00666796|Drug|Placebo|Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
16297013|NCT00666796|Drug|Gabapentin|Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
16297014|NCT00666796|Drug|Ethanol|Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
16297015|NCT00666796|Drug|Placebo|Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
16297016|NCT00666796|Drug|Gabapentin|Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
16297017|NCT00666796|Drug|Placebo ethanol|Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
16297018|NCT00666783|Drug|palonosetron|receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.
16297019|NCT00666783|Drug|Granisetron|receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.
16297020|NCT00666770|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
16297021|NCT00666770|Drug|Gabapentin|Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
16297022|NCT00666770|Drug|Placebo|Matched placebo 30 minutes prior to bedtime
16297023|NCT00666757|Drug|duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
16297024|NCT00666757|Drug|fluoxetine|20-80 mgs orally daily for 12 weeks
16297025|NCT00666757|Drug|citalopram|20-40 mgs orally daily for 12 weeks
16297026|NCT00666757|Drug|paroxetine|20-50 mgs orally daily for 12 weeks
16297027|NCT00666757|Drug|sertraline|50-200 mgs orally daily for 12 weeks
16297028|NCT00666744|Other|Family Mediated Exercise Therapy|35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks.
16297029|NCT00666731|Other|medical chart review|Demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history.
16297030|NCT00666731|Other|questionnaire administration|Collection of personal information, medical history, diet and lifestyle habits, any past or current environmental exposures and to re-create a family tree for any cancers that have occurred in any family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, year of birth, age of death) will be recorded.
16297031|NCT00666731|Other|study of socioeconomic and demographic variables|Repository
16297032|NCT00666731|Procedure|Excess human biological tissue|Tissue procurement.
16297033|NCT00666731|Procedure|quality-of-life assessment|Cancer care.
16297034|NCT00666718|Drug|Insulin Glargine|patient glucose-level dependent, injection, once daily in the evening, 24 weeks
16297035|NCT00666718|Drug|Insulin Lispro Protamine Suspension (ILPS)|patient glucose-level dependent, injection, once daily in the evening, 24 weeks
16297036|NCT00666718|Drug|Insulin Lispro|subcutaneous injections prior to meals, 24 weeks
16297037|NCT00666705|Drug|Maraviroc|300 milligrams(mg) every 12 hours Days 6-11
16297038|NCT00666705|Drug|Maraviroc|Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
16297039|NCT00666705|Drug|Raltegravir|Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
16297040|NCT00666705|Drug|Raltegravir|400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5
16297041|NCT00666692|Drug|M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab|Volociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
16297042|NCT00666679|Drug|Comparator: mometasone|mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
16297043|NCT00666679|Drug|Comparator: montelukast|montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
16297044|NCT00666679|Drug|Comparator: placebo (unspecified)|Placebo (Placebo once-daily, for approximately 2 weeks)
16297045|NCT00666666|Drug|AT-101|AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
16297046|NCT00666666|Drug|Bicalutamide|Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
16297047|NCT00666666|Other|LHRH agent|An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
16297048|NCT00666653|Drug|pramipexole|
16297049|NCT00666640|Device|DXA scan of hip|Dual-energy X-ray Absorptiometry scan
16297050|NCT00666640|Device|CT scan of hip|Computed Tomography scan
16297051|NCT00666627|Drug|Ibandronate|once monthly
16297052|NCT00666627|Drug|Risedronate|Risedronate 35mg once weekly
16297053|NCT00666627|Drug|Alendronate|Alendronate 70mg once weekly
16297054|NCT00666614|Other|Sleep Environment Intervention|Patients randomized to the sleep environment intervention months will experience a relaxation period before nighttime sleep, white noise as selected by the patient, stimulus control strategies, a window covering to diminish hallway light from entering the room, and a nurse-protected 90-minute uninterrupted sleep period at night.
16297055|NCT00666614|Other|Normal Hospital Environment|Normal Hospital Environment
16297056|NCT00666601|Drug|TR-700 (active moiety)|A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of approximately 2 µg/mL at a flow rate of 1.5 µL/min for 60 minutes for a total maximum dose of 0.36 µg (0.18 µg per probe).
16297057|NCT00666601|Drug|TR-701 (pro-drug)|Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701
16297058|NCT00666588|Drug|idarubicin|Given IV
16297059|NCT00666588|Drug|cytarabine|Given IV or IT
16297060|NCT00666588|Drug|bortezomib|Given IV
16297061|NCT00666588|Drug|etoposide|Given IV
16297062|NCT00666588|Other|laboratory biomarker analysis|Correlative studies
16297063|NCT00666575|Drug|Gabapentin|Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
16297064|NCT00666575|Drug|Placebo|Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
16297065|NCT00666562|Dietary Supplement|Defined Green Tea Catechin Extract|Given orally
16297066|NCT00666562|Other|Laboratory Biomarker Analysis|Correlative studies
16297067|NCT00666562|Other|Pharmacological Study|Correlative studies
16297068|NCT00666562|Drug|Placebo|Given orally
16297069|NCT00666562|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16297070|NCT00666536|Drug|valsartan and amlodipine|
16297071|NCT00666536|Drug|valsartan and amlodipine|
16297072|NCT00666523|Dietary Supplement|phytalgic|3/day
16297073|NCT00666523|Dietary Supplement|placebo|3/Day
16297074|NCT00666497|Drug|Azacitidine|75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle
16297075|NCT00666497|Drug|MGCD0103|90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle
16297076|NCT00666497|Drug|MGCD0103|90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle
16297077|NCT00666484|Drug|cyclophosphamide|
16297078|NCT00666484|Drug|doxorubicin hydrochloride|
16297079|NCT00666484|Drug|etoposide|
16297080|NCT00666484|Drug|prednisolone|
16297081|NCT00666484|Drug|procarbazine hydrochloride|
16297082|NCT00666484|Drug|vincristine sulfate|
16297083|NCT00666484|Radiation|radiation therapy|
16297084|NCT00666471|Procedure|MICE|MICE
16297085|NCT00666471|Procedure|SPA ligation|SPA ligation
16297086|NCT00666458|Drug|saxagliptin|tablet, per oral, once daily
16297087|NCT00666458|Drug|sitagliptin|capsule, per oral, once daily
16297088|NCT00666432|Other|This is an observational study model that is family based|This is an observational study model that is family based
16297089|NCT00666419|Other|Measurement, weight, and muscle strength test|10-12 year old schoolchildren will be weighed, measured for height, and tested for strength of their abdominal and paravertebral muscles
16297090|NCT00666406|Drug|Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)|Infusion of 50 +/- 5 IU/kg bodyweight
16297091|NCT00666406|Drug|Recombinant Factor VIII (rAHF)|Infusion of 50 +/- 5 IU/kg bodyweight
16297092|NCT00666393|Drug|fentanyl iontophoretic transdermal system (40mcg) No placebo|40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
16297093|NCT00666393|Drug|fentanyl iontophoretic transdermal system (40mcg)|40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
16297094|NCT00666380|Biological|Plasmodium falciparum Malaria Protein 010 (FMP010)|Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
16297095|NCT00666367|Drug|D-cure|4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.
16297096|NCT00666367|Drug|Placebo|4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.
16297097|NCT00666354|Drug|Methotrexate|0.01 gram of topical amphimatrix containing 0.05% methotrexate per affected nail and adjacent skin folds applied daily for three months.
16297098|NCT00666354|Drug|Methotrexate|0.01 gram of topical amphimatrix containing 0.25% methotrexate per affected nail and adjacent skin folds applied daily for three months.
16297099|NCT00666354|Drug|Methotrexate|0.01 gram of topical amphimatrix containing 1.0% methotrexate per affected nail and adjacent skin folds applied daily for three months.
16297100|NCT00666341|Drug|placebo|Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
16297101|NCT00666341|Biological|rPhleum|Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
16297102|NCT00666341|Biological|rPhleum|Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
16297103|NCT00666341|Biological|rPhleum|Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
16297104|NCT00666341|Biological|rPhleum|Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
16297105|NCT00666328|Drug|clevidipine|"Clevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line.
~Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be attempted as needed to obtain the target systolic blood pressure (SBP) range (SBP ≤160 mmHg to ≥140 mmHg). Titration to effect was to proceed by doubling the dose every 1.5 minutes, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) was attained. The clevidipine infusion rate could be increased or decreased to maintain systolic blood pressure for up to a maximum of 96 hours."
16297106|NCT00666302|Drug|tacrolimus ointment|topical
16297107|NCT00666302|Drug|pimecrolimus cream|topical
16297108|NCT00666276|Drug|linezolid (Zyvox)|"Zyvox Tablets 600mg, Zyvox Injection 600mg Dosage, Frequency: According to Japanese Package Insert, In adults, administer usually 600mg of linezolid twice daily (q 12 hours) for a total daily dose of 1200 mg.
~Duration: According to the protocol of A5951142, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 8 weeks after the first administration."
16297109|NCT00666263|Biological|Immune Globulin Intravenous (human), 10%|Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)
16297110|NCT00666263|Biological|0.25% human albumin solution (Placebo)|Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1
16297111|NCT00666250|Dietary Supplement|Xocai Activ drink|proprietary blend of cocoa powder and extracts of acai, grape and blueberry
16297112|NCT00666237|Procedure|Tube shunt surgery|The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
16297113|NCT00666237|Procedure|Trabeculectomy|The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
16297114|NCT00666237|Drug|Mitomycin C|A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
16297115|NCT00666224|Drug|Glatiramer Acetate (DB)|Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS).
16297116|NCT00666224|Drug|Placebo|Double blind period (DB): subcutaneous injection of placebo, once daily, for up to 36 months or until conversion to CDMS
16297117|NCT00666224|Drug|Glatiramer Acetate (OL)|Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months.
16297118|NCT00666211|Other|educational intervention|Participants will be educated on pain management.
16297119|NCT00666211|Other|Titrated pain management|Pain will be Monitored and Medication Titrated
16297120|NCT00666211|Other|questionnaire administration|Participants will be given questionnaires to complete.
16297121|NCT00666198|Drug|SILDENAFIL|"Revatio® Tablets 20 mg Dosage, Frequency: According to Japanese LPD, For oral use, the adult dose is 20 mg three times a day.
~Duration: According to the protocol of A1481263, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 3 years after the first administration."
16297122|NCT00666185|Drug|Micafungin|IV
16297123|NCT00666185|Drug|Fluconazole|IV
16297124|NCT00666172|Behavioral|Exercise|
16297126|NCT00666159|Drug|tacrolimus ointment|topical
16297127|NCT00666159|Drug|pimecrolimus cream|topical
16297128|NCT00666133|Device|SpringFusor Pump|Women in Group I (Springfusor® arm) will receive loading and maintenance doses of magnesium sulfate administered via an IV infusion administered with the Springfusor pump, a simple, inexpensive flow-controlled pump system.
16297129|NCT00666120|Other|Enfamil LIPIL with iron|cow's milk based infant formula
16297130|NCT00666120|Other|Good Start Supreme with DHA and ARA|partially hydrolzed cow's milk protein
16297131|NCT00666107|Biological|Gardasil|Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6
16297132|NCT00666094|Behavioral|Endurance training|supervised endurance training. Three sessions per week in three months.
16297133|NCT00666094|Behavioral|strength training|Supervised strength training. Three sessions per week in three months.
16297134|NCT00666081|Drug|GSK690693|Administered intravenously at a concentration between 0.1 - 4.8 mg/mL by slow infusion over 4 h.
16297135|NCT00666068|Other|corticotropin releasing hormone (CRH)|50 µg injected at 2200, 2300, 0000, and 0100
16297136|NCT00666068|Other|Placebo|injected at 2200, 2300, 0000, and 0100
16297137|NCT00666068|Other|Placebo|injected at 2200, 2300, 0000, and 0100
16297138|NCT00666055|Drug|ARV regimen chosen by treating physician|"Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir).
~Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI)."
16297139|NCT00666042|Drug|Vigamox - administration in spray form|Vigamox will be administered in a spray form
16297140|NCT00666042|Drug|Vigamox eye drops|Vigamox eye drops
16297141|NCT00666029|Drug|atorvastatin|40 m.g. o.d. tablets for 6 months
16297142|NCT00666029|Drug|placebo|Placebo
16297143|NCT00666016|Drug|TRO19622|TRO19622 500 mg once a day before noon meal during 6 weeks
16297144|NCT00665990|Drug|Bevacizumab|Bevacizumab starting dose of 5 mg/kg every 3 weeks increasing in combination with Sorafenib and Cyclophosphamide until maximum tolerated dose
16297145|NCT00665990|Drug|Sorafenib|Sorafenib 90 mg/m2 PO every 12 hours increasing in combination with Bevacizumab and Cyclophosphamide until maximum tolerated dose
16297146|NCT00665990|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/m2 PO once daily increasing in combination with Bevacizumab and Sorafenib until maximum tolerated dose
16297147|NCT00665977|Drug|Thermosmart & placebo|a Fisher & Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily
16297148|NCT00665977|Drug|Placebo Device & Nasacort|Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher & Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
16297149|NCT00665977|Device|Placebo Arm|"To enter into the single-blind placebo phase, subjects will be setup with a Fisher & Paykel 604 CPAP unit with a heated humidifier and deactivated Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still appear to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily."
16297150|NCT00665964|Device|X-3 polyethylene|highly cross-linked polyethylene for knee arthroplasty
16297151|NCT00665964|Device|N2Vac polethylene|conventional polyethylene
16297152|NCT00665951|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
16297153|NCT00665951|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
16297154|NCT00665951|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
16297155|NCT00665938|Other|Infant formula|"Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)
~Arm 2. partially hydrolyzed infant formula with probiotics
~Arm 3. extensively hydrolyzed infant formula with probiotics"
16297156|NCT00665925|Drug|Fostamatinib disodium (R935788)|100 mg tablet, orally, twice-a-day
16297157|NCT00665925|Drug|Fostamatinib disodium (R935788)|150 mg tablet, orally, once a day
16297158|NCT00665925|Drug|Placebo|Placebo, orally, either once a day, or twice a day
16297159|NCT00665912|Procedure|Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively|GPS is used to create the platelet rich plasma (PRP). Plasmax is used to create the concentrated platelet-poor plasma (PPPc). Both PRP and PPPc will be used for wound care in the thoracic cavity post-lobectomy.
16297160|NCT00665912|Procedure|Standard post-lobectomy wound care|Standard post-lobectomy wound care
16297161|NCT00665899|Behavioral|Cancer-Focused Relationship Enhancement|Couples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues.
16297162|NCT00665899|Behavioral|Couple's Cancer Education|Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.
16297163|NCT00665886|Device|Open Intravenous System - Vasocan®|Vasocan® Safety catheter 18 G x 45 mm (Ref. 4248139S), 20 G x 33 mm (Ref. 4248112S) y 22 G x 25 mm (Ref. 4248090S)with wings and a passive safety mechanism. To the control catheters a three-way tap ('stopcock') with extension tubing 10 cm long (Connecta® Extra 3) from BD (ref 394995)will be added.
16297164|NCT00665886|Device|Closed Intravenous System - Nexiva®|BD Nexiva® Catheter (18G x 45 mm, 20 G x 32 mm, 22 G x 25 mm) (Ref. 383609,Ref. 383606,Ref. 383602) BD QSyte®, Ref. 385100 Catheter material is Vialon®. The entire system is Latex and PVC free.
16297165|NCT00665873|Device|PORT-A-CATH (Smiths Medical Inc., MN)|Port a Cath implanted by surgical cut-down
16297166|NCT00665873|Drug|Amoxicillin and clavulanic acid|1 gr i.v. before the procedure
16297167|NCT00665860|Dietary Supplement|Placebo|Three pills per day for two years
16297168|NCT00665860|Dietary Supplement|Soy isoflavones|Three pills that delivered 80 mg of aglycone isoflavones per day for two years
16297169|NCT00665860|Dietary Supplement|Soy isoflavones|Three pills that delivered 120 mg aglycone isoflavones per day for two years
16297170|NCT00665847|Drug|Etravirine (TMC125)|Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.
16297171|NCT00665847|Drug|Optimized background regimen (OBR)|An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir [LPV], darunavir [DRV], atazanavir [ATV] or saquinavir [SQV]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N[t]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.
16297172|NCT00665834|Drug|rosuvastatin|rosuvastatin 20 mg from day 0 to (maximum) day 6
16297173|NCT00665834|Drug|placebo|placebo 20 mg from day 0 to (maximum) day 6
16297174|NCT00665834|Drug|rosuvastatin|rosuvastatin 20 mg from discharge until the end of the study
16297175|NCT00665834|Drug|atorvastatin|atorvastatin 80 mg from discharge until the end of the study
16297176|NCT00665821|Behavioral|Classic back pain prevention education, and cognitive behavioral management.|Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.
16297177|NCT00665821|Behavioral|General health education|General health education: a booklet describing general norms for maintaining good health
16297178|NCT00665808|Drug|insulin detemir|"Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany"
16297179|NCT00665808|Drug|isophane human insulin|"Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany"
16297180|NCT00665782|Other|laboratory biomarker analysis|
16297181|NCT00665782|Other|questionnaire administration|
16297182|NCT00665782|Other|study of socioeconomic and demographic variables|
16297183|NCT00665782|Procedure|assessment of therapy complications|
16297184|NCT00665782|Procedure|psychosocial assessment and care|
16297185|NCT00665782|Procedure|therapeutic conventional surgery|
16297186|NCT00665769|Other|Hypercapnia|transcutaenous CO2 50-60 mm Hg
16297187|NCT00665769|Other|Normocapnia|transcutaneous CO2 35-45 mm Hg
16297188|NCT00665756|Procedure|second Trabeculectomy|second trabeculectomy with mitomycin-c
16297189|NCT00665756|Procedure|Ahmed Implant|Ahmed silicone drainage device
16297190|NCT00665743|Drug|PN400|naproxen 500 mg /esomeprazole 20 mg
16297191|NCT00665743|Drug|naproxen|naproxen 500 mg tablet
16297192|NCT00665743|Drug|naproxen|naproxen 500 mg
16297193|NCT00665730|Device|Sepraspray|
16297194|NCT00665717|Drug|Pravastatin|40 mg tablet; QD; 4 days
16297195|NCT00665717|Drug|Raltegravir|400mg tablet; BD 4 days
16297196|NCT00665717|Drug|Pravastatin and raltegravir|pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
16297197|NCT00665704|Behavioral|Tobacco Tactics website|Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers
16297198|NCT00665691|Other|Nutritional Screening Tools|To compare the nutrition risk identification abilities of two nutrition screening tools: PEDSGA tool and the standard assessment tool.
16297199|NCT00665678|Drug|paroxetine|treatment for three months with paroxetine
16297200|NCT00665678|Drug|placebo|treatment for three months with placebo
16297201|NCT00665665|Drug|NNC 0070-0002-0182|4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
16297202|NCT00665665|Drug|placebo|Placebo for s.c. injection
16297203|NCT00665665|Drug|NNC 0070-0002-0182|12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
16297204|NCT00665665|Drug|NNC 0070-0002-0182|32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
16297205|NCT00665665|Drug|NNC 0070-0002-0182|60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
16297206|NCT00665652|Drug|Lenalidomide|Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
16297207|NCT00665639|Drug|micafungin|IV
16297208|NCT00665639|Drug|caspofungin|IV
16297209|NCT00665626|Drug|Fostamatinib disodium (R935788)|R935788 100 mg tablet, orally, twice-a-day
16297210|NCT00665626|Drug|Placebo|Placebo, orally, twice-a-day
16297211|NCT00665600|Drug|Levalbuterol HCl|Levalbuterol 0.63 TID
16297212|NCT00665600|Drug|Levalbuterol HCl|Levabuterol 1.25 mg TID
16297213|NCT00665600|Drug|Albuterol Sulfate|Racemic albuterol 2.5 mg TID
16297214|NCT00665600|Drug|Placebo|Placebo TID
16297215|NCT00665587|Procedure|Cox-MAZE III|Maze procedure according to standards of the department
16297216|NCT00665574|Other|ActaVisc and ActaVisc Mx Intra-articular Injection|ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.
16297217|NCT00665561|Drug|Maraviroc along with an optimized background antiretroviral drug regimen|Maraviroc prescribed per approved local label.
16297218|NCT00665561|Drug|Optimized background antiretroviral drug regimen without maraviroc|Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
16297219|NCT00665548|Radiation|X-ray; magnetic resonance imaging|"Knee x-rays: acquired in both a standard or weight-bearing position and in non-weight-bearing position to measure joint space width and look at signs of osteoarthritis.
~3 Tesla MRI: magnetic resonance imaging of the study knee during weight-bearing conditions and traditional non-loaded condition all acquired with the same sequences."
16297220|NCT00665535|Procedure|Turning or repositioning schedule|Turning schedule randomly assigned at 2, 3, or 4 hours
16297221|NCT00665535|Procedure|Turning or repositioning schedule|Turning schedule randomly assigned at 2, 3 or 4 hours
16297222|NCT00665522|Drug|fentanyl iontophoretic transdermal system (40mcg) No Placebo|40 mcg per dose, maximum of 6 doses/hour
16297223|NCT00665522|Drug|IV PCA with standard of care opioid analgesia|total maximum 80 doses/24 hours
16297810|NCT00661648|Device|the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)|artificial pancreas
16297224|NCT00665509|Biological|Trivalent influenza subunit vaccine Influvac|3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1
16297225|NCT00665496|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10 mg and 20 mg orally once a day as needed
16297226|NCT00665496|Drug|Placebo|Matching Placebo
16297227|NCT00665483|Other|Skin Prick Test|Skin Prick Test
16297228|NCT00665470|Drug|Aldesleukin|"High-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
~Receive low-dose aldesleukin subcutaneously (SC) once daily 5 days a week for up to 6 weeks"
16297229|NCT00665457|Biological|filgrastim|
16297230|NCT00665457|Drug|capecitabine|
16297231|NCT00665457|Drug|celecoxib|
16297232|NCT00665457|Drug|cyclophosphamide|
16297233|NCT00665457|Drug|docetaxel|
16297234|NCT00665457|Drug|doxorubicin hydrochloride|
16297235|NCT00665457|Genetic|gene expression analysis|
16297236|NCT00665457|Genetic|polymorphism analysis|
16297237|NCT00665457|Genetic|protein expression analysis|
16297238|NCT00665457|Genetic|reverse transcriptase-polymerase chain reaction|
16297239|NCT00665457|Other|imaging biomarker analysis|
16297240|NCT00665457|Other|immunohistochemistry staining method|
16297241|NCT00665457|Other|laboratory biomarker analysis|
16297242|NCT00665457|Other|pharmacogenomic studies|
16297243|NCT00665457|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16297244|NCT00665457|Procedure|needle biopsy|
16297245|NCT00665457|Procedure|neoadjuvant therapy|
16297246|NCT00665457|Procedure|radiomammography|
16297247|NCT00665457|Procedure|ultrasound imaging|
16297248|NCT00665444|Drug|Aripiprazole|All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
16297249|NCT00665431|Drug|PN 400 (VIMOVO)|500 mg naproxen/20 mg esomeprazole bid
16297250|NCT00665431|Drug|celebrex|200 mg celecoxib qd
16297251|NCT00665431|Other|Placebo|sugar pill bid
16297252|NCT00665431|Drug|Rescue Antacid|Antacid Tablets
16297253|NCT00665418|Drug|sevoflurane|sevoflurane 2.5% versus 4.7% (inhaled concentration) 10min each
16297254|NCT00665405|Radiation|CT scan|Thoracic CT scan
16297255|NCT00665392|Drug|cisplatin|75 mg/m², day 1. 3 cycles
16297256|NCT00665392|Drug|docetaxel|75 mg/m² Day 1. 3 cycles
16297257|NCT00665392|Drug|fluorouracil|750 mg/m² day 1 to day 5. 3 cycles
16297258|NCT00665392|Drug|Cetuximab|400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
16297259|NCT00665379|Other|Regular Compression therapy (Trico bandages)|Application of marketed Trico compression bandages used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. The bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours
16297260|NCT00665379|Other|New Compression therapy (C2L bandages)|Application of marketed compression bandages C2L used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. he bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours
16297261|NCT00665366|Drug|Aripiprazole|5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
16297262|NCT00665366|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 12 weeks
16297263|NCT00665366|Drug|Lithium|Participant's ongoing dose
16297264|NCT00665366|Drug|Valproate|Participant's ongoing dose
16297265|NCT00665353|Drug|pioglitazone|Traditionally used in the treatment of type 2 diabetes to increase insulin sensitivity. Participants will take 30 mg daily in tablet form.
16297266|NCT00665353|Drug|peginterferon|Used in the treatment of HCV. Participants will receive 180 mcg subcutaneously once a week.
16297267|NCT00665353|Drug|ribavirin|Used in the treatment of HCV. Participants will receive 1000 to 1200 mg orally per day depending on weight.
16297268|NCT00665340|Drug|Placebo|Matching placebo
16297269|NCT00665340|Drug|Levitra (Vardenafil, BAY38-9456)|5m, 10 mg and 20 mg 1 h prior to sexual intercourse
16297270|NCT00665327|Drug|Avelox (Moxifloxacin, BAY12-8039)|Moxifloxacin 400 mg IV QD for a minimum of two doses followed by moxifloxacin 400 mg PO QD for a total treatment duration of 7 to 14 days
16297271|NCT00665327|Drug|Levofloxacin|Levofloxacin 500 mg IV QD for a minimum of two doses followed by Levofloxacin 500 mg PO QD for a total treatment duration of 7 to 14 days. For patients who have a documented or calculated creatinine clearance of 20 - 49 ml/minute, the IV and PO dose of Levofloxacin will be a 500 mg loading dose followed by 250 mg QD for a total treatment duration of 7 to 14 days
16297272|NCT00665314|Drug|Plerixafor (AMD3100)|0.24mg/kg SC for 2 to 7 days.
16297273|NCT00665314|Drug|Can be any registered nonpegylated form of G-CSF|10mcg/kg SC for 4 days followed by an additional 2 to 7 days.
16297274|NCT00665262|Drug|tramacet|2 tablets every 6 hours for 5 days
16297275|NCT00665249|Behavioral|Motivational Interviewing|See MotivationalInterviewing.org
16297276|NCT00665249|Behavioral|Spirit-Only Motivational Interviewing|Non-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit.
16297277|NCT00665249|Other|Self-Change|Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.
16297278|NCT00665236|Other|Craniosacral therapy|Eight weekly 45-minute sessions with therapist
16297279|NCT00665236|Procedure|Low strength static magnets|Placement of magnets on/around subject body by therapist; frequency: weekly for 45-minutes x 8 weeks
16297280|NCT00665223|Drug|ACR16|45 mg capsules Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.
16297376|NCT00664521|Drug|Atacicept|Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
16297281|NCT00665223|Drug|Placebo|Placebo capsules. Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.
16297282|NCT00665197|Radiation|Protracted Course Radiotherapy|External Beam Radiation 30 Gy in 10 fractions
16297283|NCT00665197|Radiation|Short Course Radiotherapy|External Beam Radiation 20 Gy in 5 fractions
16297284|NCT00665184|Behavioral|Resistance Exercise via Negative Eccentric Work|High intensity resistance training delivered 2-3 times per week for 12 weeks
16297285|NCT00665184|Behavioral|Standard care exercise training|Evidence based exercise training (resistance training, aerobic training, flexibility training) 2-3 times per week for 12 weeks.
16297286|NCT00665158|Behavioral|UC (Usual Care Group)|Usual Care Group - Treatment Implementation by Primary Care Physician
16297287|NCT00665158|Behavioral|BI (Behavioral Intervention Group)|Behavioral Intervention Group - Treatment Implementation by Health Educator
16297288|NCT00665145|Drug|SB-509|Active drug
16297289|NCT00665145|Drug|SB-509|Active drug
16297290|NCT00665145|Drug|Placebo|Placebo
16297291|NCT00665145|Drug|SB-509|Active drug
16297292|NCT00665132|Device|StimRouter System|Implanted with StimRouter System receive 6 hours (or less if not tolerated by the Subject)of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)
16297293|NCT00665119|Drug|remifentanil|0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion
16297294|NCT00665119|Drug|placebo|NaCl 0.9 %
16297295|NCT00665106|Drug|"NOVA63035 Corticosteroid"|Single injection in the study eye
16297296|NCT00665093|Drug|biphasic insulin aspart 30|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
16297297|NCT00665093|Drug|insulin detemir|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
16297298|NCT00665054|Drug|Levitra (Vardenafil, BAY38-9456)|5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
16297299|NCT00665054|Drug|Placebo|Matching placebo tablets orally prior to sexual activity
16297300|NCT00665041|Drug|Quinagolide|"• Quinagolide 200 μg/day (dose titration from 50 μg/day to 100 μg/day to 200 μg/day), oral. Quinagolida tablets, 50 mcg.
~placebo, oral."
16297301|NCT00665002|Biological|WT-1|Immune responses were to be evaluated at weeks 6 and 12 via delayed-type hypersensitivity, CD4 T cell proliferation, CD4 and CD8 T cell interferon release, as well as by bone marrow cytogenetics including polymerase chain reaction (PCR) to look for molecular evidence of disease. Patients who had an immunologic response and had not had disease progression could continue with up to 6 more vaccinations administered approximately every month. In that case, patients were to be reevaluated with bone marrows/immunologic studies after the 9th and 12th vaccination. In addition, patients would undergo evaluations for residual disease including immunohistochemistry and/or quantitative polymerase chain reaction (RQ-PCR) for WT-1 expression (on selected patients), and multiparameter flow cytometry (AML/ MDS).
16297302|NCT00665002|Drug|Montanide|The WT-1 vaccine is given with another substance, called Montanide, which clumps the WT-1 vaccine and thereby improves the immune response.
16297303|NCT00665002|Drug|Sargramostim (GM-CSF)|GM-CSF was administered at a dose 70 mcg (140ul) as a subcutaneous injection at the site of vaccination on day -2 and day 0.
16297304|NCT00664976|Procedure|Electroconvulsive therapy|Electroconvulsive therapy
16297305|NCT00664976|Other|Treatment as usual|Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.
16297306|NCT00664963|Device|Implantation of YUKON Sirolimus-eluting Stent|Implantation of YUKON Sirolimus-eluting Stent
16297307|NCT00664963|Device|Implantation of YUKON Stent (uncoated)|Implantation of YUKON Stent (uncoated)
16297308|NCT00664950|Device|sliding hip screw|surgical repair of hip fracture using conventional sliding hip screw
16297309|NCT00664950|Device|IntertAn IM nail|interTAN IM nail
16297310|NCT00664937|Drug|montelukast sodium|single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration.
16297311|NCT00664937|Drug|Comparator: placebo (unspecified)|single oral dose, before exercise challenge, of Pbo; 7 week duration.
16297312|NCT00664911|Other|chemotherapy|
16297313|NCT00664898|Drug|bortezomib|Escalating intravenous repeating dose
16297314|NCT00664898|Drug|SGN-40|Escalating intravenous repeating dose
16297315|NCT00664885|Other|Culturally Sensitive Collaborative Treatment|a collaborative care model, for treating depressed patients in general medical care
16297316|NCT00664872|Other|proactive psychosocial intervention by care managers|A case manager will be assigned to each of the participants in the intervention group. All case managers are psychologists. After discharge from the emergency department, the participants receive six sessions of proactive psychosocial intervention by their case manager over four months. Duration of each session is approximately 30 minutes. The intervention consists of telephone or face-to-face contacts with the case manager at scheduled intervals or when clinically necessary. If a patient declines medication therapy from the psychiatrist, case manager will provide psychotherapy using the model of cognitive-behavioural approach and problem-solving therapy. Case managers will receive backup and supervision by psychiatrist investigators and monthly supervision of therapy. Case managers will regularly monitor suicide risk, clinical status and provide follow-up.
16297317|NCT00664872|Behavioral|case management|
16297318|NCT00664859|Drug|LCP-AtorFen|All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.
16297319|NCT00664846|Drug|Aspirin / Clopidogrel, Atorvastatin / Simvastatin|Standard Medical Management,including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .
16297377|NCT00664521|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.
16297320|NCT00664846|Drug|Asprin / Clopidogrel, Atorvastatin / Simvastatin|Antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary
16297321|NCT00664833|Behavioral|Levitra (Vardenafil, BAY38-9456)|The Primary Care Physician (PCP) received the educational intervention
16297322|NCT00664833|Behavioral|Levitra (Vardenafil, BAY38-9456)|The Subject received the educational intervention
16297323|NCT00664833|Behavioral|Levitra (Vardenafil, BAY38-9456)|Both the Primary Care Physician (PCP) and the subject received the educational intervention
16297324|NCT00664833|Other|No Education|No education provided to either the Primary Care Physician (PCP) or the subject.
16297325|NCT00664820|Dietary Supplement|Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14|2 capsules daily for 3 months.
16297326|NCT00664794|Procedure|without acromioplasty|This group will not have their acromion shaved - instead they will receive a repair of their rotator cuff with the scope using sutures or suture anchors.
16297327|NCT00664794|Procedure|with acromioplasty|This group will have Their rotator cuff repaired with sutures or suture anchors and additionally will have the tip of their acromion bone shaved slightly.
16297328|NCT00664781|Drug|rucaparib (CO-338; formally AG-014699 or PF-01367338)|
16297329|NCT00664781|Genetic|protein expression analysis|
16297330|NCT00664781|Genetic|western blotting|
16297331|NCT00664781|Other|immunohistochemistry staining method|
16297332|NCT00664781|Other|liquid chromatography|
16297333|NCT00664781|Other|mass spectrometry|
16297334|NCT00664781|Other|pharmacological study|
16297335|NCT00664768|Dietary Supplement|Neocate Infant|minimum of 8 fl. oz daily
16297336|NCT00664768|Dietary Supplement|new Neocate|minimum of 8 fl oz daily
16297337|NCT00664755|Drug|varenicline|"Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID
~Varenicline is taken for a duration of 4 weeks in this study."
16297338|NCT00664755|Device|transdermal nicotine patch|"Weeks 0-3: 21mg patch
~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
16297339|NCT00664742|Drug|Fluvastatin XL®|Fluvastatin extended release 80 mg
16297340|NCT00664729|Behavioral|Caloric Restriction|Reduced calorie diet (400 kcal/day deficit)
16297341|NCT00664729|Behavioral|Caloric Restriction + Low-Intensity aerobic exercise|400 kcal/day deficit plus 3 days/week aerobic exercise at 45-50% maximal aerobic fitness
16297342|NCT00664729|Behavioral|Caloric Restriction plus High-intensity aerobic exercise|400 kcal/day deficit and 3 d/week of aerobic exercise at 65-75% maximal fitness
16297343|NCT00664716|Biological|Baminercept alfa 1|experimental - one dose level
16297344|NCT00664716|Biological|Placebo|Placebo comparator
16297345|NCT00664716|Biological|Baminercept alfa 2|experimental - second dose level
16297346|NCT00664716|Biological|Baminercept alfa 3|experimental - third dose level
16297347|NCT00664716|Biological|Baminercept alfa 4|experimental - fourth dose level
16297348|NCT00664716|Biological|Baminercept alfa 5|experimental - fifth dose level
16297349|NCT00664703|Drug|Lobeline sulfate|Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.
16297350|NCT00664703|Drug|Methylphenidate HCl|Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.
16297351|NCT00664703|Drug|Placebo|Each laboratory day, participants will receive one capsule containing either methylphenidate HCl (15 or 30 mg) or placebo, and one sublingual tablet containing either lobeline (7.5, 15, or 30 mg) or placebo.
16297352|NCT00664690|Drug|celebrex|400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
16297353|NCT00664690|Drug|placebo|placebo given preop and BID postop
16297354|NCT00664677|Drug|Terameprocol (EM-1421)|Terameprocol (EM-1421) as a single agent given intravenously over 6 hours three times a week for two weeks followed by one week rest (two weeks on, one week off.
16297355|NCT00664664|Drug|APD125|soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
16297356|NCT00664664|Drug|APD125|soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
16297357|NCT00664664|Drug|Placebo|soft gelatin capsule, daily dosing for up to 3 weeks
16297358|NCT00664638|Device|Symplicty(TM) Catheter System|Renal denervation using the Symplicity Catheter System
16297359|NCT00664625|Drug|BMS-791325|Capsules, Oral, Once Daily, Single Dose
16297360|NCT00664625|Drug|Placebo|Capsules, Oral, Once Daily, Single Dose
16297361|NCT00664612|Device|AirTraq|Laryngoscopy with AirTraq
16297362|NCT00664599|Drug|Rituximab|Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).
16297363|NCT00664599|Drug|Cytotoxic Combination|Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.
16297364|NCT00664586|Drug|Terameprocol (EM-1421)|Weekly (3 of 4 consecutive weeks) 24 hour continuous intravenous infusion
16297365|NCT00664573|Biological|Baminercept alfa (BG9924)|dosage administered as per Biogen-Idec protocol
16297366|NCT00664560|Drug|PN 400 (VIMOVO)|500 mg naproxen/20 mg esomeprazole bid
16297367|NCT00664560|Drug|celebrex|200 mg celecoxib qd
16297368|NCT00664560|Drug|Placebo|sugar pill bid
16297369|NCT00664560|Drug|Rescue Antacid|Antacid Tablets
16297370|NCT00664547|Behavioral|Diet Weight Loss|
16297371|NCT00664547|Behavioral|Exercise Weight Loss|
16297372|NCT00664547|Behavioral|Exercise Without Weight Loss|
16297373|NCT00664534|Drug|Insulin Glargine|patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks
16297374|NCT00664534|Drug|Insulin Lispro Premix (mid-mixture and low-mixture)|patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks
16297375|NCT00664521|Biological|Rituximab|Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
16297378|NCT00664508|Procedure|Motion analysis|Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach
16297379|NCT00664495|Behavioral|Diet Weight Loss|
16297380|NCT00664495|Behavioral|Exercise Weight Loss|
16297381|NCT00664495|Behavioral|Exercise Without Weight Loss|
16297382|NCT00664482|Biological|AGS-006|Autologous Therapy for Pancreatic Cancer
16297383|NCT00664469|Drug|ezetimibe|ezetimibe 10 mg/day over a 6-week course of treatment.
16297384|NCT00664469|Drug|Comparator: Simvastatin 20, 40 and 80 mg|Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
16297385|NCT00664469|Drug|Comparator: Atorvastatin|Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
16297386|NCT00664469|Drug|Comparator: Rosuvastatin|Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
16297387|NCT00664456|Drug|Adjuvant therapy|AHT group receives 9 cycle of LHRH-A (goserelin acetate 3.6 mg/4 weeks or leuprorelin acetate 3.75 mg/4 weeks) after Iodine I-125 implantation (TPPB).
16297388|NCT00664456|Drug|Neoadjuvant therapy|3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
16297389|NCT00664456|Radiation|Brachytherapy（iodine I 125）|Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
16297390|NCT00664443|Behavioral|Dispatch-assisted CPR Instructions|Pre and post assessment of bystander CPR frequency and impact on victim survival related to Dispatch-assisted CPR Instructions given since 2004
16297391|NCT00664430|Drug|Calcitriol|Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals.
16297392|NCT00664430|Drug|Paricalcitol|Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals.
16297393|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 1
16297394|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 2
16297395|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 3
16297396|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 4
16297397|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 5
16297398|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Formulation 6
16297399|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Comparator 1
16297400|NCT00664417|Biological|Monovalent subvirion H5N1 influenza vaccine|0.5 mL, IM, 2 injections, Comparator 2
16297401|NCT00664417|Biological|Physiological saline|0.5 mL, IM, 2 injections
16297402|NCT00664404|Other|Functional Magnetic Resonance Imaging (fMRI)|Functional Magnetic Resonance Imaging (fMRI)of the Brain, one session while smoking, and one session while abstinent from smoking (not smoking).
16297403|NCT00664391|Drug|Lactic acid (Dermacid)|Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days
16297404|NCT00664378|Drug|CYT997|Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle
16297405|NCT00664365|Drug|GSK958108|GSK958108 oral tablets will be available with dosing strengths of 1 milligram, 5 milligrams, 25 milligrams and 50 milligrams. It will be a brownish-yellow film coated round shape tablet. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.
16297406|NCT00664365|Drug|Placebo|Placebo tablets will be brownish-yellow film coated round shape tablets, administered orally. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.
16297407|NCT00664352|Drug|Mannose-6-Phosphate (Juvidex)|"100µL of 300mM (8.46 mg/100μL) Juvidex will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of 300mM (8.46 mg/100μL) Juvidex will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.
~100µL of placebo will be injected intradermally into each cm2 of the other 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest."
16297408|NCT00664352|Drug|Mannose-6-Phosphate (Juvidex)|"100µL of 600mM(16.93 mg/100μL) Juvidex will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of 600mM (16.93 mg/100μL) Juvidex will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.
~100µL of placebo will be injected intradermally into each cm2 of the other 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest."
16297409|NCT00664352|Drug|Mannose-6-Phosphate (Juvidex)|"300µL of 300mM (8.46 mg/100μL) Juvidex will be applied topically to one 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest.
~300µL of placebo will be applied topically to the other 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest."
16297410|NCT00664352|Drug|Mannose-6-Phophate (Juvidex)|"300µL of 600mM (16.93 mg/100μL) Juvidex will be applied topically to one 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest.
~300µL of placebo will be applied topically to the other 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest."
16297488|NCT00663858|Other|Placebo|Placebo on Week 0, Week 2, Week 26 and Week 28
16297489|NCT00663845|Drug|Levitra (Vardenafil, BAY38-9456)|10mg Vardenafil taken orally 1h prior to sexual intercourse
16297490|NCT00663845|Drug|Placebo|Matching placebo
16297411|NCT00664352|Drug|Placebo|"100µL of placebo will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.
~Standard Care (moist wound healing dressings alone) will be applied to the other 3cm2 donor site."
16297412|NCT00664339|Biological|Flu Vaccine|Single dose of Flu vaccine by year (1)
16297413|NCT00664339|Other|Conventional medical therapy for heart failure|According with the international guidelines
16297414|NCT00664326|Drug|Regorafenib (Stivarga, BAY73-4506)|Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.
16297415|NCT00664313|Drug|Linezolid|600 mg po daily for 112 doses (16 weeks)
16297416|NCT00664313|Drug|Placebo|Placebo given daily for 112 doses (16 weeks)
16297417|NCT00664300|Behavioral|Facial expression recognition of emotion|Facial expression recognition test Lexical decision test
16297418|NCT00664287|Drug|niacin (+) laropiprant|Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
16297419|NCT00664287|Drug|placebo (unspecified)|Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.
16297420|NCT00664274|Behavioral|Cognitive remediation therapy|36 sessions of Computerized Cognitive Skills Training, 3 per week for 12 weeks.
16297421|NCT00664274|Genetic|COMT Genotyping|One time saliva sample is taken to genotype catechol-O-methyltransferase Val158/108Met alleles.
16297422|NCT00664261|Behavioral|smoking cessation intervention|
16297423|NCT00664261|Other|cancer prevention|
16297424|NCT00664261|Other|counseling intervention|
16297425|NCT00664261|Other|educational intervention|
16297426|NCT00664261|Other|laboratory biomarker analysis|
16297427|NCT00664261|Other|questionnaire administration|
16297428|NCT00664261|Other|survey administration|
16297429|NCT00664261|Procedure|study of high risk factors|
16297430|NCT00664248|Drug|IDP-110|Topical application for 12 weeks
16297431|NCT00664248|Drug|Clindamycin|Topical application for 12 weeks
16297432|NCT00664248|Drug|Benzoyl peroxide|Topical application for 12 weeks
16297433|NCT00664248|Drug|Vehicle|Topical application for 12 weeks
16297434|NCT00664222|Drug|spironolactone + furosemide|spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks
16297435|NCT00664209|Drug|clartihromycin, amoxicillin, and omeprazole|clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
16297436|NCT00664209|Drug|placebo|placebo therapy
16297437|NCT00664196|Biological|Gene Modified T Cells|One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
16297438|NCT00664183|Drug|Vitreosolve|Intravitreal injection
16297439|NCT00664170|Drug|ANX-514|75 mg/m^2
16297440|NCT00664170|Drug|docetaxel|75 mg/m^2
16297441|NCT00664157|Behavioral|Facial expression recognition of emotion|Facial expression recognition test Lexical decisiontest
16297442|NCT00664157|Behavioral|Facial expression recognition of emotion|Facial expression recognition test Lexical decision test
16297443|NCT00664144|Drug|Rasburicase (SR29142)|
16297444|NCT00664131|Other|Neurological Examination/Questionnaires|See Detailed Description section for description of treatment plan.
16297445|NCT00664118|Procedure|Doula combined analgesia|Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas
16297446|NCT00664118|Procedure|Analgesia without doula|Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas
16297447|NCT00664105|Drug|Carboplatin|"Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
~Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment."
16297448|NCT00664105|Drug|Docetaxel|"Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
~Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks)."
16297449|NCT00664105|Radiation|radiation therapy|Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
16297450|NCT00664092|Other|Residential|living in a democratic, resident-run setting
16297451|NCT00664092|Other|Residential|Professionally-run substance abuse recovery setting
16297452|NCT00664079|Other|Blood draws|17 mls of blood will be drawn over a 5 day period from either a central venous catheter/arterial line or with scheduled phlebotomy. The following labs will be run tT3, fT3, rT#, tT4, fT4, TSH, and tyrosine.
16297453|NCT00664066|Drug|DYNEPO (epoetin delta)|dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits, as this is an observational study
16297454|NCT00664053|Dietary Supplement|DHEA|50mg daily for 6 months
16297455|NCT00664053|Behavioral|Yoga|2 sessions per week for 6 months
16297456|NCT00664053|Dietary Supplement|Placebo|Placebo supplement every day for 6 months
16297457|NCT00664053|Behavioral|Aerobics|Walking/chair aerobics program 2 sessions per week for 6 months
16297491|NCT00663832|Drug|LBH589 (i.v. panobinostat)|"i.v. LBH589 dose levels: 10, 15, or 20 mg/m2
~i.v. docetaxel 75 or 60 mg/m2
~oral prednisone 5mg bid.
~LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle"
16297492|NCT00663819|Device|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
16297493|NCT00663819|Procedure|Staple line without reinforcement|colorectal and coloanal anastomotic staple line without reinforcement
16297458|NCT00664040|Other|Aspirin|The aspirin intervention (81 mg per day) will last a total of 14 days. Pills will be provided in a pre-loaded pillbox. The field team will visit the subject at his/her home at least once to insure adherence to the aspirin intervention and to monitor for adverse side effects. On day 14 of the aspirin intervention, the subject will visit the clinic for a fasting blood draw for platelet aggregation and inflammatory marker studies. A pill count will be performed to assess adherence. The subject can miss up to four aspirin doses over the two-week period; however, an aspirin must be taken each day for the three days prior to clinic visit 2. The aspirin intervention can be extended for up to three days (17 days total) to meet the latter criteria. If more than four doses were missed, then the physician should be contacted and the patient should be withdrawn from the aspirin intervention. Platelet aggregation will be measured 1 hour after the last dose of aspirin.
16297459|NCT00664040|Other|Cold Pressor Test|This intervention consists of the participant placing his or her hand and wrist into ice water for 2½ minutes. The blood pressure is taken before and after the arm is removed from the water. An ultrasound machine is used to take pictures of the brachial artery in the left arm before and after the arm is removed from the water.
16297460|NCT00664040|Other|High Fat Meal|The participants are given a high fat milk shake consisting of 83% fat. Blood samples are drawn from a catheter placed in the participant's arm prior to the test. The samples are drawn before the milk shake and at 1, 2, 3, 4, and 6 hours after the milk shake is consumed. Before and at 2, 4 and 6 hours following the meal the ultrasound is used to obtain images of the brachial artery.
16297461|NCT00664040|Other|Dietary Salt|The salt intervention will consist of 6 days of an isocaloric high salt diet (270 mmol/d) followed by a washout period of at least 8 days and then a low salt diet (40 mmol/d). All food will be prepared by a registered dietician and dietary technicians in a specially equipped kitchen. The specific foods will consist of approximately 50% carbohydrates, 35% fat, and 15% protein. Dietary potassium will remain constant at 120 mmol/d. A food diary will be kept for each diet and subjects will be instructed to eat only the food provided. A field nurse will visit the home on days 3 and 5 of each diet to insure that neither diet is acutely affecting the health status of the subject. A first AM void spot urine will be obtained to measure sodium, potassium and creatinine on the 4th, 5th, and 6th days of each diet to insure compliance. Blood pressure will be measured using an ambulatory blood pressure monitor for 24 hours on the last day of each diet.
16297462|NCT00664027|Drug|RTA 402 (Bardoxolone Methyl)|Stratum 1: 25, 75, 150mg/day, orally, 28 consecutive days Stratum 2: 25 mg/day, orally, 28 consecutive days followed by 75 mg/day, orally, 28 consecutive days
16297463|NCT00664014|Drug|Tolvaptan|Tablet;15mg/tab;15/30/60mg/day for 7days Plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.
16297464|NCT00664014|Drug|Placebo|placebo plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.
16297465|NCT00664001|Dietary Supplement|Anti-oxidant supplementation|Daily dose of 1g L-ascorbic acid, 400 IU of alpha-tocopherol acetate, and 600mg of alpha-lipoic acid in sealed capsules as anti-oxidant supplementation.
16297466|NCT00664001|Dietary Supplement|Matched placebo for anti-oxidant supplementation|Matched placebo for anti-oxidant supplementation
16297467|NCT00663988|Procedure|human transplantation|Allograft composite tissue transplantation. procedure. medication
16297468|NCT00663975|Drug|DCI 1020|capsules (4,000 units of lipase) will be administered with meals and snacks
16297469|NCT00663962|Drug|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
16297470|NCT00663962|Drug|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)
16297471|NCT00663949|Drug|Captopril|25 mg captopril tablet q8h
16297472|NCT00663949|Drug|Captopril + Pentoxifylline|patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h
16297473|NCT00663936|Drug|T-817MA|224 mg T-817 MA once daily
16297474|NCT00663936|Drug|Placebo|Placebo once daily
16297475|NCT00663923|Procedure|photorefractive keratectomy (PRK)|comparison of PRK by cross-cylinder approach in one eye and conventional (single) method in the other eye for laser correction of astigmatism
16297476|NCT00663910|Drug|Aminolevulinic Acid|On Day 1, ALA will then be applied topically to the center of the tumor surface (at the location of its greatest diameter) in a standardized manner with great care not to include normal skin. The solution will be applied directly to the lesions by dabbing gently with a wet applicator tip. Enough solution will be applied to uniformly wet the exposed lesion surface. Once the initial application has dried, the ALA will be applied again in the same manner. The ALA will be left on for 2 hours under occlusion with Duoderm Extra Thin®.
16297477|NCT00663910|Procedure|biopsy|Then local anesthesia, lidocaine 1% with epinephrine 1:100,000, will be administered and before the tumor is excised by one of the Cleveland Clinic MOHS surgeons, a 2mm punch biopsy will be taken from the area where the ALA was previously applied. The punch biopsy will be full thickness, extending to the subcutaneous fat.
16297478|NCT00663910|Procedure|diagnostic imaging technique|Two hours after the amniolevlulenic acid was applied, the measurements of surface fluorescence will be repeated with the hand held dosimeter.
16297479|NCT00663910|Procedure|therapeutic conventional surgery|The non-melanoma skin cancer will be excised using the MOHS procedure.
16297480|NCT00663897|Drug|lansoprazole|lansoprazole, 30 mg, once daily for 14 days
16297481|NCT00663897|Drug|mosapride|mosapride, 5 mg, thrice daily for 14 days
16297482|NCT00663884|Drug|Mitiglinide|mitiglinide 10mg three times a day before a meal
16297483|NCT00663884|Drug|Voglibose|voglibose 0.2mg three times a day before a meal
16297484|NCT00663871|Dietary Supplement|Fish Oil|Participants will take 2 grams (1400 mg EPA and DHA) of fish oil supplements on a daily basis.
16297485|NCT00663871|Dietary Supplement|Soybean Oil (Placebo)|Participants will take 2 grams of soybean oil supplements on a daily basis.
16297486|NCT00663858|Drug|Cetrorelix 78+78|Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
16297487|NCT00663858|Drug|Cetrorelix 78 + Placebo|Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
16297961|NCT00660543|Other|MRI-Based Angiogram|Undergo TOF MR angiography
16297494|NCT00663806|Behavioral|Cipro XR (Ciprofloxacin, BAYQ3939)|Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
16297495|NCT00663806|Behavioral|Cipro XR (Ciprofloxacin, BAYQ3939)|Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI
16297496|NCT00663793|Drug|Acyline|300 mcg/kg
16297497|NCT00663793|Drug|Testosterone|"24 hours after acyline administration on Day 2 immediate release Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
16297498|NCT00663793|Drug|Finasteride|1 mg PO once daily [day -2 to day 12) 14 days total
16297499|NCT00663767|Drug|Placebo; oral|dose 1, dose 2
16297500|NCT00663767|Drug|Placebo; oral|dose 1
16297501|NCT00663767|Drug|ARRY-371797, p38 inhibitor; oral|dose 1: multiple dose levels
16297502|NCT00663767|Drug|ARRY-371797, p38 inhibitor; oral|dose 1: multiple dose levels; dose 2
16297503|NCT00663767|Drug|Celecoxib, COX-2 inhibitor; oral|dose 1
16297504|NCT00663767|Drug|Placebo; oral|dose 2
16297505|NCT00663767|Drug|ARRY-371797, p38 inhibitor; oral|dose 2
16297506|NCT00663754|Behavioral|Dissonance-based eating disorder prevention program|Participants will engage in verbal, written, and behavioral exercises in which they will critique the thin ideal. These exercises will be conducted in sessions and in homework activities. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal.
16297507|NCT00663754|Behavioral|Educational brochure|Participants will receive a mailed educational brochure about a healthy body image only.
16297508|NCT00663741|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle
16297509|NCT00663741|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle
16297510|NCT00663741|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle
16297511|NCT00663728|Drug|Levitra (Vardenafil, BAY38-9456)|10mg Vardenafil taken orally 1 hour prior to sexual intercourse
16297512|NCT00663728|Drug|Placebo|Matching placebo
16297513|NCT00663715|Other|Observation of the Sciatic Nerve|Ultrasound will be used to determine the location of the Sciatic Nerve using a lateral mid-thigh approach.
16297514|NCT00663702|Drug|Abatacept|Subcutaneous injection, 125 mg/mL, once weekly, 48 months
16297515|NCT00663689|Drug|erlotinib|erlotinib 150mg qd until disease progression or unacceptable toxicity.
16297516|NCT00663663|Behavioral|Telephone-Delivered Intervention 1|Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Each intervention 1 session will include a brief relaxation exercise practiced over the phone.
16297517|NCT00663663|Behavioral|Telephone-Delivered Intervention 2|Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain.
16297518|NCT00663650|Procedure|Permanent Section Control|After surgical excision of the tumor, margins will be sent for permanent section pathologic control to determine if the tumor was completely excised
16297519|NCT00663650|Procedure|Frozen Section Control|After surgical excision of the tumor, tumor edges will be analyzed by frozen section at the time of surgery. If tumor margins are positive with the frozen section, additional tissue will be excised and analyzed again. This process will be repeated until all tissue edges are clear of tumor. Finally, the area of tumor excision will be surgically reconstructed.
16297520|NCT00663637|Device|CAM (Complete Airway Management) Catheters|Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.
16297521|NCT00663624|Drug|aspart insulin|subcutaneous aspart insulin every 2 hours
16297522|NCT00663624|Drug|Usual care as prescribed by the ED physicians.|Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine
16297525|NCT00663598|Drug|Levitra (Vardenafil, BAY38-9456)|Treatment according to US PI
16297526|NCT00663585|Behavioral|Vipassana Meditation|12 day retreat where participants learn to meditate
16297527|NCT00663559|Drug|Sunitinib|Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
16297528|NCT00663533|Device|Vas-X|mechanical vasectomy device
16297529|NCT00663481|Drug|CoFactor|
16297530|NCT00663481|Drug|Leucovorin|
16297531|NCT00663455|Drug|Reduction of cyclosporine A (CSA)-dosing|Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).
16297532|NCT00663442|Drug|OROS methylphenidate|18, 36, 54 mg
16297533|NCT00663429|Drug|Atiprimod|Oral, 14 days on / 14 days off; 30mg capsules
16297534|NCT00663416|Drug|NTx™-265: rhCG, then rEPO|"rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then
~rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation"
16297535|NCT00663416|Drug|Saline placebo|"Saline SC, on Day 1, 3, and 5 of study participation, then
~Saline IV, on Day 7, 8, and 9 of study participation"
16297536|NCT00663403|Drug|Daptomycin|Daptomcyin 8 mg/kg infused intravenously every 48 hours
16297537|NCT00663390|Drug|Lactic acid (Dermacid)|Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
16297538|NCT00663377|Drug|losartan|losartan 50-100mg for 16 weeks
16297539|NCT00663364|Drug|Physiogel AI Lotion, Physiogel Lotion|Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin
16297540|NCT00663351|Device|Reflection Ceramic-Ceramic Total Hip Replacement|Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
16297541|NCT00663351|Device|Reflection FSO V Total Hip Replacement|Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
16297542|NCT00663338|Drug|Rotigotine|Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.
16297543|NCT00663325|Drug|Lactic acid (Dermacid)|Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
16297544|NCT00663312|Behavioral|e.g., Protein and calorie controlled diet; Self-hypnotic relaxation|Pilot description
16297545|NCT00663299|Device|Endovascular Embolization Device|The TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils are each an embolic coil system that consists of a platinum detachable coil, a delivery system (delivery tube and coil introducer) and a syringe. Each system has been designed to deliver, position and detach embolic coils in order to embolize intracranial aneurysms
16297546|NCT00663286|Drug|IDP-110|Topical application for 12 weeks
16297547|NCT00663286|Drug|Clindamycin|Topical application for 12 weeks
16297548|NCT00663286|Drug|Benzoyl peroxide|Topical application for 12 weeks
16297549|NCT00663286|Drug|Vehicle|Topical application for 12 weeks
16297550|NCT00663273|Drug|Lactic acid (Dermacid)|Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
16297551|NCT00663260|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once Daily, 104 weeks
16297552|NCT00663260|Drug|Dapagliflozin|Tablets, Oral, 5 mg, Once Daily, 104 weeks
16297553|NCT00663260|Drug|Placebo|Tablets, Oral, 0 mg, Once Daily, 104 weeks
16297554|NCT00663247|Device|Mesalazine|3 grams daily for 3 months
16297555|NCT00663247|Drug|Placebo|3 grams daily for 3 months
16297556|NCT00663234|Drug|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
16297557|NCT00663221|Dietary Supplement|Anthocyans, Calcium and Vitamin D|
16297558|NCT00663221|Dietary Supplement|placebo|
16297559|NCT00663208|Drug|Daclatasvir|Capsule, Oral, Approximately 182 days from initial dosing
16297560|NCT00663208|Drug|Placebo|Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
16297561|NCT00663195|Drug|spironolactone + furosemide|spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16 weeks
16297562|NCT00663182|Drug|Entecavir|Entecavir 0.5 mg/d
16297563|NCT00663169|Biological|canakinumab|10 mg/kg intravenous infusion 250 mL over 2 hours.
16297564|NCT00663169|Drug|dexamethasone|12 mg intravenous infusion 50 mL over 30 minutes.
16297565|NCT00663169|Other|placebo matching canakinumab|5% glucose in water intravenous infusion.
16297566|NCT00663169|Other|placebo matching dexamethasone|Placebo intravenous infusion.
16297567|NCT00663156|Procedure|breast implants|patients will have breast augmentation using implants
16297568|NCT00663156|Procedure|Liposuction, fat grafting|Autologous fat will be harvested from the body (typically the abdomen or thighs) using syringe aspiration techniques and then infiltrated into the subcutaneous tissue around the breast as well as between the breast and the underlying musculature using blunt cannulas. These procedures will be done in an outpatient surgery setting in the Georgetown University Hospital under general anesthesia and sterile conditions.
16297569|NCT00663143|Procedure|Stromal Cells Sample|Human Bone Marrow Stromal Cells will be obtained from 5 patients. Stromal cells will be obtained from subjects undergoing bone graft procedure to repair traumatic mandible fractures. Bone graft specimens will be obtained from the ileac crest. This will allow easy access to bone marrow specimen without additional pain or complications. A total of 5 ml of bone marrow will be obtained from each patient.
16297570|NCT00663130|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
16297571|NCT00663130|Drug|Tadalafil|Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse
16297572|NCT00663117|Drug|Naltrexone-HCl|naltrexone 4.5 mg
16297573|NCT00663117|Drug|Placebo|Placebo
16297574|NCT00663104|Behavioral|exercise|exercise: 3 joint sessions/week for 12 months
16297575|NCT00663104|Behavioral|exercise + cimicifuga racemosa|exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
16297576|NCT00663104|Behavioral|wellness control, placebo|2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo
16297577|NCT00663091|Drug|Bacteriophage|"WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages (component bacteriophages or component phages) lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants."
16297625|NCT00662779|Drug|placebo|placebo dry powder capsules ( lactose) and placebo normal saline for nebulization
16297626|NCT00662766|Dietary Supplement|black currant seed press residue|Black currant seed press residue, baked into bread
16298105|NCT00659490|Drug|AZD1940|800ug oral administration
16297578|NCT00663091|Drug|WPP-201 Bacteriophage|"WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages (component bacteriophages or component phages) lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants."
16297579|NCT00663091|Drug|Bacteriophages|"WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages (component bacteriophages or component phages) lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants."
16297580|NCT00663078|Behavioral|Brief CBT Group therapy|CBT based therapy also expert patient programme
16297581|NCT00663065|Drug|PAZ-417|
16297582|NCT00663052|Drug|Etanercept|ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
16297583|NCT00663052|Drug|Etanercept|ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
16297584|NCT00663039|Drug|Oxytocin|24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)
16297585|NCT00663039|Drug|Placebo|Single dose (plus a booster dose) drug probe study using intranasal placebo
16297586|NCT00663026|Drug|bapineuzumab|5 mg bapineuzumab subcutaneous injection once per week for 6 months
16297587|NCT00663026|Drug|bapineuzumab|10 mg bapineuzumab subcutaneous injection once per week for 6 months
16297588|NCT00663026|Drug|placebo|Placebo subcutaneous injection once per week for 6 months
16297589|NCT00663013|Other|Virtual Reality|Virtual reality (VR) gives patients an illusion of going into the 3-D computer generated environment/virtual world. During VR, the subject wears a head-mounted virtual reality helmet that positions two goggle-sized miniature LCD computer screens close to the subject's eyes. Position tracking devices keep the computer informed of changes in the patient's head location. An electro-magnetic head orientation device feeds the x, y, z coordinates of the patient's head to the computer, which can quickly change what the patient sees in virtual reality accordingly. The scenery in VR changes as the patient moves her head orientation (e.g., virtual objects in front of the patient in VR get closer as the patient, wearing the VR helmet, leans forward in the real world).
16297590|NCT00662987|Drug|7 days of amoxicillin|Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
16297591|NCT00662987|Drug|3 days of amoxcillin followed by 4 days of placebo|3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo
16297592|NCT00662974|Other|perineal massage with Wheat Germ Oil during the second stage of labor|30 ml of oil applied during labor
16297593|NCT00662974|Other|perineal massage with almond oil during the second stage of labor|30 ml of oil applied during labor
16297594|NCT00662961|Procedure|Periosteum|Periosteum fixation
16297595|NCT00662961|Procedure|Bone|Bone tunnel fixation
16297596|NCT00662948|Drug|Rituximab|375 mg/m2 every 8 weeks during 24 months
16297597|NCT00662948|Drug|Ibritumomab tiuxetan|One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
16297598|NCT00662935|Procedure|setting-up of an electrode in deep brain|deep brain stimulation of the postero-inferoir hypothalamus
16297599|NCT00662909|Drug|Mirabegron|Oral
16297600|NCT00662909|Drug|Placebo|Oral
16297601|NCT00662896|Drug|naproxcinod 375 mg bid|naproxcinod 375 mg bid
16297602|NCT00662896|Drug|naproxcinod 750 mg bid|naproxcinod 750 mg bid
16297603|NCT00662896|Drug|naproxen 250 mg bid|naproxen 250 mg bid
16297604|NCT00662896|Drug|naproxen 500 mg bid|naproxen 500 mg bid
16297605|NCT00662896|Drug|ibuprofen 600 mg tid|ibuprofen 600 mg tid
16297606|NCT00662883|Drug|PMI-150 (intranasal ketamine HCl); mometasone furoate|"1 dose PMI-150 (intranasal ketamine HCl); day 1
~mometasone furoate, daily; days 2-15
~1 dose PMI-150 (intranasal ketamine HCl); day 15"
16297607|NCT00662870|Biological|DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)|0.5 mL, Intramuscular
16297608|NCT00662870|Biological|Pentacel: DTaP-IPV/Hib|0.5 mL, Intramuscular
16297609|NCT00662857|Drug|Technosphere® Insulin Inhalation Powder|TI Inhalation Powder, two 15 U cartridges
16297610|NCT00662857|Drug|Technosphere Insulin® Inhalation Powder|TI Inhalation Powder, one 30 U cartridge
16297611|NCT00662857|Drug|RAA Population|RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
16297612|NCT00662844|Dietary Supplement|vitamin D3|Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1000-1200 mg/day
16297613|NCT00662831|Drug|Fragmin/ Dalteparin Sodium|Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
16297614|NCT00662831|Drug|Placebo for Fragmin/ Dalteparin Sodium|Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
16297615|NCT00662818|Drug|Telcagepant|Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)
16297616|NCT00662818|Drug|Acetaminophen/Paracetamol|Acetaminophen/Paracetamol (500 mg X 2 dosage units)
16297617|NCT00662818|Drug|Placebo to Telcagepant|Placebo 300 mg soft gel capsules or placebo 280 mg tablet.
16297618|NCT00662818|Drug|Placebo to Acetaminophen/Paracetamol|Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)
16297619|NCT00662805|Drug|Salmeterol/Fluticasone propionate|Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)
16297620|NCT00662792|Drug|Tiotropium plus Salmeterol|
16297621|NCT00662792|Drug|Tiotropium|
16297622|NCT00662792|Drug|Salmeterol|
16297623|NCT00662779|Drug|arformoterol|15 mcg arformoterol nebulizer
16297624|NCT00662779|Drug|formoterol|Formoterol 12 mcg/inhalation, dry powder inhaler
16297627|NCT00662766|Dietary Supplement|Bread without black currant seed press residues|Same bread but without seeds
16297628|NCT00662766|Dietary Supplement|Baseline data|No supplement was administered.
16297629|NCT00662753|Device|Home monitoring|Participants will receive a home blood pressure monitor and be taught how to use it. They will have an education session to review treatment goals, medications, diet and exercise. They will be asked to see their primary care provider at least every 3 months and the research nurse at 3, 6 and 12 months.
16297630|NCT00662753|Other|monitor & phone call|Participants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse
16297631|NCT00662740|Drug|Tiotropium/Salmeterol QD|Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
16297632|NCT00662740|Drug|Placebo|Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
16297633|NCT00662740|Drug|Salmeterol|Salmeterol Inhalation Powder, hard PE capsule
16297634|NCT00662740|Drug|Tiotropium/Salmeterol QD+ Salmeterol|Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
16297635|NCT00662740|Drug|Tiotropium|Tiotropium
16297636|NCT00662727|Device|Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)|Energy Density - 0.09 mJ/mm2
16297637|NCT00662727|Device|Placebo|Placebo
16297638|NCT00662714|Drug|Repaglinide|oral; initial dose: 3x 0.5mg/d; 2 years
16297639|NCT00662714|Drug|short-acting Insulin (Actrapid)|initial dose: 3x 0.05E/kg/d, injected; 2 years
16297640|NCT00662701|Procedure|Catheter Ablation|RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring.
16297641|NCT00662701|Procedure|Surgical Ablation|Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
16297642|NCT00662688|Drug|daltéparine|
16297643|NCT00662688|Drug|Chemotherapy at the investigator's discretion|
16297644|NCT00662675|Drug|Pancrease MT 10.5, or MT 21|Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day
16297645|NCT00662675|Drug|Placebo for Pancrease MT 10.5 or MT 21|Capsules with Pancrease MT excipients without the active enzymes
16297646|NCT00662662|Behavioral|Questionnaire|The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
16297647|NCT00662649|Drug|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
16297648|NCT00662649|Drug|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
16297649|NCT00662636|Drug|dasatinib|Given orally
16297650|NCT00662636|Drug|lapatinib ditosylate|Given orally
16297651|NCT00662636|Other|pharmacological study|Correlative study (cohort II only)
16297652|NCT00662636|Other|laboratory biomarker analysis|Correlative study (cohort II only)
16297653|NCT00662623|Behavioral|i-PAP|Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
16297654|NCT00662623|Behavioral|Usual Care (Standard Care)|Pre-determined clinic visits and telephone support
16297655|NCT00662610|Drug|naproxcinod 375 mg -750 mg -1125 mg bid|naproxcinod 375 mg -750 mg -1125 mg bid
16297656|NCT00662610|Drug|naproxen 250 mg - 500mg -750 mg bid|naproxen 250 mg - 500mg -750 mg bid
16297657|NCT00662597|Drug|ASA404|
16297658|NCT00662597|Drug|Placebo|
16297659|NCT00662597|Drug|carboplatin|
16297660|NCT00662597|Drug|Paclitaxel|
16297661|NCT00662584|Procedure|Repetitive transcranial magnetic stimulation (rTMS)|transcranial magnetic stimulation (TMS) at .5 HZ for 20s
16297662|NCT00662571|Drug|acamprosate|acamprosate 333mg tabs, 2tabs 3times per day = 1998mg/day
16297663|NCT00662558|Drug|celecoxib|200 mg capsules BID for 6 weeks
16297664|NCT00662558|Drug|tramadol HCL|50 mg capsules QID for 6 weeks
16297665|NCT00662545|Drug|Entecavir with continued standard of care antiretroviral therapy|1 mg by mouth daily
16297666|NCT00662545|Drug|continued standard of care with tenofovir in addition to emtricitabine or lamivudine|continued standard of care with tenofovir in addition to emtricitabine or lamivudine
16297667|NCT00662532|Drug|Minocycline HCl|1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
16297668|NCT00662519|Drug|Neulasta (Pegylated)|Subjects will receive 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.
16297669|NCT00662519|Drug|Placebo|Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.
16297670|NCT00662519|Dietary Supplement|Mixed Meal Tolerance Test (MMTT)|This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed.
16297671|NCT00662519|Other|Blood test|HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
16297672|NCT00662519|Other|DNA Test|The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
16297673|NCT00662506|Drug|Cediranib Maleate|Given PO
16297674|NCT00662506|Procedure|Diffusion Tensor Imaging|Undergo DTI
16297675|NCT00662506|Procedure|Diffusion Weighted Imaging|Undergo T1 weighted DCE-MRI
16297676|NCT00662506|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE-MRI
16297677|NCT00662506|Radiation|Fludeoxyglucose F-18|Undergo 18 FDG PET
16297678|NCT00662506|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16297679|NCT00662506|Other|Laboratory Biomarker Analysis|Correlative studies
16297680|NCT00662506|Procedure|Perfusion Magnetic Resonance Imaging|Undergo PWI
16297681|NCT00662506|Procedure|Positron Emission Tomography|Undergo 18 F FDG-PET
16297682|NCT00662506|Drug|Temozolomide|Given PO
16297683|NCT00662493|Behavioral|Motor control retraining program|Specific retraining of VMO activation in a low-load situation,and progressed to integrate more functional positions. Use of dual channel biofeedback was incorporated
16297776|NCT00661895|Drug|Amlodipine|5 mg tablets & 10 mg tablets
16297684|NCT00662493|Behavioral|Quadriceps strengthening program|4 exercises focused on quadriceps strengthening commencing at a resistance of 60% 1 repetition maximum. Each exercise was performed for 3 sets of 10 repetitions
16297685|NCT00662480|Procedure|Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm|Invited to vascular screening
16297686|NCT00662467|Drug|aspirin + clopidogrel|Dual therapy
16297687|NCT00662467|Drug|aspirin + clopidogrel + warfarin|Triple therapy
16297688|NCT00662454|Drug|ethinyl estradiol / levonorgestrel|Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
16297689|NCT00662454|Drug|ethinyl estradiol / levonorgestrel|Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
16297690|NCT00662441|Drug|Levitra (Vardenafil, BAY38-9456)|10mg taken 1 hours before sexual intercourse
16297691|NCT00662428|Other|Symptom based discharge management|Depressive symptoms of patients are weekly assessed by Beck Depression Inventory (BDI II). Patients are discharged when BDI-score is under 20 points. Patients are treated in the same hospital for two more weeks as outpatients before being referred to outpatient care (general practitioner or specialist).
16297692|NCT00662428|Other|Treatment as usual|Treatment as usual is the usual stationary depression treatment which consists of a combination of several psychopharmacological and psychotherapeutical treatments. Duration of treatment is varying widely.
16297693|NCT00662415|Device|mirror-box treatment|15 minutes daily for 4 weeks
16297694|NCT00662415|Behavioral|observation|observation
16297695|NCT00662402|Other|Extensive Consultations|receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.
16297696|NCT00662389|Device|Apsara Thermal Wand System|Single radiofrequency cycle to dermal tissue
16297697|NCT00662376|Dietary Supplement|PreOP Booster (oral nutritional supplement, food for special medical purposes)|3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
16297698|NCT00662363|Drug|Lubiprostone|24 µg po BID given with meals for 6 days
16297699|NCT00662363|Drug|Senna|2 tabs daily for 6 days
16297700|NCT00662350|Device|The Wallterm™ System|The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).
16297701|NCT00662337|Drug|Diphenhydramine hydrochloride|After a ten-hour fast and a one-hour fluid restriction prior to each dosing period, subjects received supervised dosing of their first 25 mg treatment with approximately eight ounces of water. Following a seven-day washout, the comparison treatment was administered according to thye same procedure.
16297702|NCT00662324|Behavioral|focus groups|"Focus group with MSKCC patients with lung, breast and prostate cancer who have taken part in clinical trials and other caregivers. This focus group will be audio recorded.
~During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would have been useful to the patient you care for in his/her experience in a clinical trial.
~The focus group to last from 60 to 90 minutes."
16297703|NCT00662324|Behavioral|focus groups|"Focus group with MSKCC patients with lung, breast and prostate cancer who have not taken part in clinical trials and other caregivers. This focus group will be audio recorded.
~During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful if the patient you care for were ever to take part in a clinical trial sometime in the future.
~We expect the focus group to last from 60 to 90 minutes."
16297704|NCT00662324|Behavioral|focus groups|"MSKCC clinicians who work with lung, breast and prostate cancer patients. This focus group will be audio recorded.
~During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful to your patients who take part in clinical trials.
~Expect the focus group to last from 60 to 90 minutes."
16297705|NCT00662311|Drug|vorinostat|Given PO
16297706|NCT00662311|Drug|paclitaxel|Given IV
16297707|NCT00662311|Radiation|radiation therapy|Undergo radiation therapy
16297708|NCT00662298|Drug|prednisolone|40mg of prednisolone once a day for 14 days
16297709|NCT00662285|Dietary Supplement|Iron supplement: Niferex 100 mg|A: 100 mg pr day in 8 days
16297710|NCT00662272|Biological|Fluzone vaccine with JVRS-100 adjuvant|One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.
16297711|NCT00662272|Biological|Fluzone vaccine|One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
16297712|NCT00662272|Biological|Fluzone vaccine|One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
16297713|NCT00662259|Drug|Alprazolam (Xanax)|Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
16297714|NCT00662259|Drug|Placebo|Placebo, bid, p.o. for 28 +/- 2 days.
16297715|NCT00662246|Radiation|respiratory gated proton beam radiotherapy|- Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.
16297716|NCT00662233|Drug|cyclophosphamide|
16297717|NCT00662233|Drug|doxorubicin hydrochloride|
16297718|NCT00662233|Drug|etoposide|
16297719|NCT00662233|Drug|ifosfamide|
16297720|NCT00662233|Drug|vincristine sulfate|
16297721|NCT00662233|Procedure|adjuvant therapy|
16297722|NCT00662233|Procedure|neoadjuvant therapy|
16297723|NCT00662233|Procedure|therapeutic conventional surgery|
16297724|NCT00662233|Radiation|brachytherapy|
16297725|NCT00662233|Radiation|intraoperative radiation therapy|
16297726|NCT00662233|Radiation|radiation therapy|
16297727|NCT00662220|Drug|ribavirin|25-29 mg/kg/day
16297728|NCT00662220|Drug|ribavirin|12-15 mg/kg/day
16297729|NCT00662207|Device|Vibrator|A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction
16297730|NCT00662207|Procedure|Anal dilator|A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter. An anal dilator is being conduced with the balloon
16297731|NCT00662155|Drug|Zolpidem|sedative-hypnotic
16297732|NCT00662155|Drug|Placebos|Placebo
16297733|NCT00662142|Dietary Supplement|docosahexaenoic acid|DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
16297734|NCT00662129|Biological|bevacizumab|
16297735|NCT00662129|Drug|gemcitabine hydrochloride|
16297736|NCT00662129|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16297737|NCT00662116|Drug|alagebrium|200 mg (two 100 mg tablets) two times daily for 24 weeks
16297738|NCT00662116|Drug|placebo|placebo tablets - two tablets taken twice daily
16297739|NCT00662103|Behavioral|exercise intervention|"Arm I (progressive, aerobic exercise program): Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
~Arm II (progressive, resistance exercise program): Patients undergo resistance exercise training 3 days a week for 18 months."
16297740|NCT00662103|Other|laboratory biomarker analysis|All biomarkers will be measured from urine, blood and plasma obtained from participants by the Oregon Health & Science University (OHSU) General Clinical Research Center (GCRC). Upon exit from the study we will confirm the presence/absence of metastatic disease, via verbal verification by the subject, in order to ensure that biomarkers were primarily reflective of bone turnover changes and not to metastases.
16297741|NCT00662103|Other|questionnaire administration|Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
16297742|NCT00662103|Other|survey administration|Administered at measured at baseline, 3, 6, 12, and 18 months
16297743|NCT00662103|Procedure|assessment of therapy complications|Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )
16297744|NCT00662103|Procedure|fatigue assessment and management|The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey
16297745|NCT00662103|Procedure|management of therapy complications|An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel.
16297746|NCT00662103|Procedure|psychosocial assessment and care|We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey
16297747|NCT00662077|Drug|Ibandronate|Ibandronate endovenous 3 mg every 3 months
16297748|NCT00662077|Behavioral|Lifestyle modifications|Lifestyle modifications: counseling every 3 months
16297749|NCT00662038|Drug|pirfenidone|Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
16297750|NCT00662025|Drug|Capecitabine|Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
16297751|NCT00662025|Drug|Sunitinib|Sunitinib 37.5 mg daily, continuous dosing
16297752|NCT00662012|Drug|Sodium Stibogluconate (SSG)|100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
16297753|NCT00661999|Biological|darbepoetin alfa|Given by injection
16297754|NCT00661999|Dietary Supplement|ferrous sulfate|Given by mouth
16297755|NCT00661999|Drug|sodium ferric gluconate complex in sucrose|Given by IV
16297756|NCT00661999|Other|placebo|Given by mouth
16297757|NCT00661986|Dietary Supplement|dark chocolate 6 g/day|dark chocolate 6 g/day
16297758|NCT00661986|Dietary Supplement|dark chocolate 25 g/day|dark chocolate 25 g/day
16297759|NCT00661973|Drug|budesonide|inhaled budesonide (turbohaler) 400 micrograms twice a day for 4 weeks
16297760|NCT00661960|Drug|raltegravir|400mg tablet twice daily by mouth for nine months
16297761|NCT00661960|Drug|efavirenz|600mg capsule once daily by mouth without regard to food
16297762|NCT00661947|Other|Dr Pepper sweetened with sucrose or high fructose corn syrup|Comparison of different formulations of fructose.
16297763|NCT00661921|Biological|AMG 108|IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
16297764|NCT00661921|Biological|Placebo|AMG 108 volume matching placebo
16297765|NCT00661895|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg tablets
16297766|NCT00661895|Drug|Lisinopril|Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
16297767|NCT00661895|Drug|Lisinopril and Hydrochlorothiazide|L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets
16297768|NCT00661895|Drug|Nifedipine XL|30 mg extended release tablets, 60 mg extended release tablets
16297769|NCT00661895|Drug|Metoprolol tartrate|50 mg tablets & 100 mg tablets
16297770|NCT00661895|Drug|Atenolol|50 mg tablet
16297771|NCT00661895|Drug|Valsartan|80 mg tablets & 160 mg tablet
16297772|NCT00661895|Drug|Doxazosin|4 mg tablets
16297773|NCT00661895|Drug|Clonidine|0.2 mg tablets
16297774|NCT00661895|Drug|Hydralazine|50 mg tablets
16297775|NCT00661895|Drug|Metoprolol succinate|50 mg tablet & 100 mg tablet
16297777|NCT00661882|Other|medical chart review|"Medical information, called protected health information (PHI), which includes demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history will be accessed from the subject's medical record."
16297778|NCT00661882|Other|questionnaire administration|Provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, age of death) will be recorded. This information will be collected by whichever method they prefer; completing the questionnaires on hardcopy (to then be entered into the PCCR by a data manager) or by logging on to the PCCR website to complete the questionnaires by obtaining a user id and password to enter their information directly into the PCCR. Study participants who are in the EDRN project are required to complete the questionnaires on hardcopy (to then be entered into the PCCR by a data manager).
16297779|NCT00661882|Other|study of socioeconomic and demographic variables|Share the information they provided with the PCCR research collaborators. This national group has formed the PCCR and is dedicated to pooling their efforts against pancreatic cancer.
16297780|NCT00661882|Procedure|biopsy|Release a portion of pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin embedded tissue that has already been collected and saved from their previous surgery or biopsy for storage in the UNMC Solid Tumor Bank for future studies done here or at collaborating institutions. All studies will be proposed in future IRB submissions.
16297781|NCT00661869|Other|Wellness Program|36 weeks of educational and supportive interventions
16297782|NCT00661856|Dietary Supplement|Soy protein|25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months
16297783|NCT00661843|Other|Integrated Yoga style practice|Intervention constitutes of 2 supervised yoga style classes per week incorporating gentle postures,relaxation and meditation sequences. In addition daily home based sessions of yogic relaxation, and meditation a an audio CD
16297784|NCT00661830|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
16297785|NCT00661830|Drug|Placebo|Placebo
16297786|NCT00661830|Drug|Sorafenib|Sorafenib 400 mg bid orally continuously
16297787|NCT00661817|Behavioral|Lifestyle Modification Program|"Participants will receive a behavior change prescription and skills training, offered via the Internet or through a combination of tailored print materials and an interactive voice response system, together with support strategies to enhance the intensity of the interpersonal and social-environmental support."
16297788|NCT00661817|Behavioral|Usual Care and Reading Materials|"Participants in this group will receive usual medical care provided by their own primary care providers. They will also receive the NHLBI's Aim for a Healthy Weight brochure at the baseline study visit and again at the beginning of Year 2."
16297789|NCT00661791|Behavioral|Massage therapy without exercise|Infants will receive massage twice a day; 15 minutes each.
16297790|NCT00661791|Behavioral|Massage therapy with exercise|Infants will receive massage with exercise twice a day; 15 minutes each.
16297791|NCT00661778|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in glass vials.
16297792|NCT00661778|Drug|Cisplatin|Bevacizumab was supplied as a sterile liquid in glass vials.
16297793|NCT00661778|Drug|Docetaxel|Bevacizumab was supplied as a sterile liquid in glass vials.
16297794|NCT00661765|Drug|varenicline tartrate|Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
16297795|NCT00661765|Drug|varenicline free base|A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
16297796|NCT00661752|Device|quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac|Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR
16297797|NCT00661752|Device|quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac|Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.
16297798|NCT00661739|Drug|Bendamustine|Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.
16297799|NCT00661726|Drug|Decitabine (USAN, INN)|Participants will receive 0.2 mg/kg of decitabine subcutaneously twice a week for 12 weeks. The dose will be reduced for toxicities as needed. The maximum dose of decitabine to be given will be 0.2 mg/kg.
16297800|NCT00661713|Biological|rMenB+OMV NZ|
16297801|NCT00661713|Biological|Placebo|
16297802|NCT00661700|Drug|Levitra (Vardenafil, BAY38-9456)|10mg Vardenafil for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg Vardenafil or down to 5mg Vardenafil followed by 14 weeks treatment at preferred dose.
16297803|NCT00661700|Drug|Placebo|10mg placebo for 4 weeks followed by an 8 week titration period when subjects may be titrated up to 20mg placebo or down to 5mg placebo followed by 14 weeks placebo at preferred dose
16297804|NCT00661687|Device|Currently Marketed PureVision Contact Lens.|Contact lens for continuous wear
16297805|NCT00661687|Device|Alternate Design of the PureVision Contact Lens.|Contact lens for continuous wear
16297806|NCT00661674|Drug|Palonosetron|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
16297807|NCT00661674|Drug|Hydroxyzine|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
16297808|NCT00661674|Other|Placebo|"Over 3 study visits, patients will receive one of the following treatment regimens:
~Placebo saline IV and sugar pill
~0.75 mg Palonosetron IV and sugar pill
~0.75 mg Palonosetron IV and 100 mg hydroxyzine PO"
16297809|NCT00661661|Drug|CP-690,550|5 mg BID up to 10 mg BID until launch
16298106|NCT00659490|Drug|Naproxen|500mg oral administration
16297811|NCT00661635|Drug|placebo|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
16297812|NCT00661635|Drug|valdecoxib|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
16297813|NCT00661635|Drug|valdecoxib|valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
16297814|NCT00661622|Drug|GM-CSF|2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
16297815|NCT00661622|Procedure|Embolization|A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
16297816|NCT00661609|Drug|AZD4877|Intravenous (IV)25mg/weekly
16297817|NCT00661596|Drug|Levitra (Vardenafil, BAY38-9456)|5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
16297818|NCT00661596|Drug|Placebo|Matching placebo
16297819|NCT00661583|Drug|Ranibizumab|0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
16297820|NCT00661583|Drug|Ranibizumab and MMC|Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
16297821|NCT00661583|Drug|MMC|MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
16297822|NCT00661570|Device|Provox Vega voice prosthesis (20 Fr)|The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system
16297823|NCT00661557|Biological|Meningococcal vaccine GSK134612 (Nimenrix)|one dose, as intramuscular injection
16297824|NCT00661544|Drug|Arsenic Trioxide|Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3.
16297825|NCT00661544|Drug|Melphalan|Dose Levels 1, 2, & 3: 100 mg/m2 IV Days -4, -3.
16297826|NCT00661544|Drug|Ascorbic Acid|Dose Levels 1, 2, & 3: 1000 mg IV Days -9 to -3.
16297827|NCT00661531|Drug|Estrace|Estrace 10 mg three times daily will be administered for 3 months.
16297828|NCT00661531|Drug|Anastrozole|After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
16297829|NCT00661505|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms iv every 4 weeks (starting dose)
16297830|NCT00661492|Drug|cetuximab|Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter
16297831|NCT00661492|Drug|Mitoxantrone|Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists
16297832|NCT00661479|Drug|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1.
16297833|NCT00661479|Drug|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1.
16297834|NCT00661479|Drug|100 µg Brimonidine Tartrate Implant|100 µg brimonidine tartrate implant in the study eye on Day 1.
16297835|NCT00661479|Other|Sham (no implant)|Sham in the fellow eye on Day 1.
16297836|NCT00661466|Drug|Bupivacaine Collagen Sponge|
16297837|NCT00661466|Drug|Placebo|placebo
16297838|NCT00661453|Drug|Valproic Acid and Levocarnitine|Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight
16297839|NCT00661440|Drug|Neramexane mesylate|2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
16297840|NCT00661427|Biological|cetuximab|Cetuximab 500 mg/m^2 IV over 2 hours every other week
16297841|NCT00661427|Biological|cetuximab|Cetuximab 750 mg/m^2 IV over 3 hours every other week
16297842|NCT00661414|Biological|ASONEP (sonepcizumab/LT1009)|"ASONEP [sonepcizumab/LT1009] is supplied as a colorless,particulate-free, pH 6.5, sterile solution containing approximately 10 mg/mL or 20 mg/mL of drug.
~The candidate drug is intended for single intravenous (iv) use administered over 90 minutes on a weekly basis."
16297843|NCT00661401|Biological|gammaglobulin|They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).
16297844|NCT00661388|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|sc every month (starting dose 1.2 micrograms/kg)
16297845|NCT00661375|Drug|Nexavar (Sorafenib, BAY43-9006)|BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.
16297846|NCT00661362|Drug|Saxagliptin|Oral tablet, once daily for 24 weeks
16297847|NCT00661362|Drug|Placebo|oral tablet, once daily for 24 weeks
16297848|NCT00661362|Drug|Metformin|oral tablet, once daily for 24 weeks
16297849|NCT00661349|Drug|Lopinavir/ritonavir|2 ITIAN (o 1 ITIAN+TDF)+ lopinavir/ritonavir, 2 tablet 200/50 mg to 12 hours
16297850|NCT00661349|Drug|Nevirapine|2 ITIAN (o 1 ITIAN+TDF)+ nevirapine, 2 tablet 200/50 mg to 12 hours
16297851|NCT00661336|Drug|buthionine sulfoximine|
16297852|NCT00661336|Drug|melphalan|
16297853|NCT00661336|Genetic|microarray analysis|
16297854|NCT00661336|Other|high performance liquid chromatography|
16297855|NCT00661336|Other|laboratory biomarker analysis|
16297856|NCT00661336|Other|pharmacological study|
16297857|NCT00661336|Procedure|biopsy|
16298107|NCT00659490|Drug|Placebo|Placebo given pre-surgery
16297858|NCT00661310|Other|Drug review 80+ -To reduce usage of hospital care|drug review performed by multiprofessional team, including clinical pharmacist, in order to optimize drug therapy and reduce usage of hospital care. Also patient education and follow-up
16297859|NCT00661297|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg Vardenafil to be taken 1 h prior to sexual attempt
16297860|NCT00661297|Drug|Placebo|Matching placebo
16297861|NCT00661271|Behavioral|Mindfulness-based stress reduction (MBSR)|8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.
16297862|NCT00661271|Behavioral|Healthy topics|8 week health education program with one retreat session
16297863|NCT00661258|Behavioral|Electronic drug monitoring feedback data|All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
16297864|NCT00661245|Device|TOGA|Transoral Gastroplasty (TOGA®) System for gastric stapling.
16297865|NCT00661245|Device|Control|The control device (bougie dilator) is a FDA-cleared (Class II) device.
16297866|NCT00661219|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
16297867|NCT00661219|Drug|Placebo|Identical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment.
16297868|NCT00661206|Drug|Clopidogrel|Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
16297869|NCT00661206|Drug|Placebo|Patients randomized in this group will receive placebo for 6 months.
16297870|NCT00661193|Drug|carboplatin|given IV
16297871|NCT00661193|Drug|erlotinib hydrochloride|given orally
16297872|NCT00661193|Drug|paclitaxel|given IV
16297873|NCT00661180|Drug|Nexavar (Sorafenib, BAY43-9006)|Patients will receive Bay 43-9006 400 mg po twice daily in a continuous, uninterrupted schedule. Treatment will continue until there is objective evidence of disease progression, or until evidence of toxicities that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.
16297874|NCT00661167|Drug|ABI-007|ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
16297875|NCT00661154|Drug|Bevacizumab|2-12microCi IV injection
16297876|NCT00661141|Drug|Antizol|
16297877|NCT00661141|Drug|Placebo|
16297878|NCT00661141|Other|Ethanol|oral dose of ethanol (0.5 g/kg)
16297879|NCT00661115|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
16297880|NCT00661115|Drug|Placebo|Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
16297881|NCT00661102|Drug|Corticosteroids|As prescribed
16297882|NCT00661102|Drug|Placebo|As prescribed
16297883|NCT00661102|Drug|capecitabine [Xeloda]|As prescribed
16297884|NCT00661102|Drug|dexpantenol [Bepantol]|As prescribed
16297885|NCT00661089|Drug|Botulinum Toxin Type A - OnabotulinumtoxinA|100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.
16297886|NCT00661089|Drug|Placebo (Saline)|Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.
16297887|NCT00661076|Drug|adefovir dipivoxil|10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
16297888|NCT00661076|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms weekly for 48 weeks
16297889|NCT00661063|Drug|ketamine|ketamine 150 mcg/g bid
16297890|NCT00661063|Drug|vehicle gel|bid - 12 weeks
16297891|NCT00661063|Drug|ketamine + clonidine|ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
16297892|NCT00661063|Drug|clonidine gel 1%|bid 12 weeks
16297893|NCT00661050|Procedure|Alternative Medicine|
16297894|NCT00661050|Procedure|Tai Chi instruction and class participation or walking exercise and sitting meditation|
16297895|NCT00661037|Device|Implantable defibrillator|Implantable defibrillator to reduce ventricular arrhythmias via shock.
16297896|NCT00661037|Device|Implantable defibrillator|Implantable defibrillator to reduce ventricular arrhythmias via shock.
16297897|NCT00661024|Procedure|intraoperative RLN visualization|intraoperative RLN visualization
16297898|NCT00661024|Procedure|intraoperative neuromonitoring of the RLN|IONM
16297899|NCT00661011|Procedure|Lobectomy followed by concomitant mediastinal chemoradiotherapy|Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29
16297900|NCT00660998|Drug|Levitra (Vardenafil, BAY38-9456)|5mg, 10mg or 20mg taken 1h before sexual intercourse
16297901|NCT00660998|Drug|Placebo|Matching placebo
16297902|NCT00660985|Drug|Adapalene|Gel, 0.3%, 2g, once daily for 30 days
16297903|NCT00660985|Drug|Adapalene|Gel, 0.1%, 2g, once daily for 30 days
16297904|NCT00660972|Drug|Raltegravir|400 mg tablet taken orally twice daily
16297905|NCT00660972|Drug|Emtricitabine/tenofovir disoproxil fumarate|Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
16297906|NCT00660959|Drug|lixivaptan|oral capsule
16297907|NCT00660959|Drug|placebo|oral capsule
16297908|NCT00660933|Drug|Iron sucrose|Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
16297909|NCT00660933|Drug|NaCl|NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
16297910|NCT00660920|Drug|Ponatinib|Comparison of different dosages of drug given orally once per day.
16298108|NCT00659477|Drug|insulin glargine|once daily
16297911|NCT00660907|Drug|dapagliflozin|Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
16297912|NCT00660907|Drug|glipizide|Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
16297913|NCT00660907|Drug|metformin hydrochloride|Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
16297914|NCT00660894|Drug|folinate calcium|
16297915|NCT00660894|Drug|tegafur-uracil|
16297916|NCT00660894|Drug|tegafur-gimeracil-oteracil potassium|
16297917|NCT00660881|Biological|Epratuzumab|Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.
16297918|NCT00660868|Drug|Pentoxifylline retard 400mg|Agapurin retard 400mg 3/day per os for 3 weeks
16297919|NCT00660855|Drug|parecoxib/valdecoxib|parecoxib 40 mg intravenously after recovery from anesthesia; if pain persisted, the patient could receive an optional second drug dose on Study Day 1 (only) if more than 4 hours after the first dose. When the patient was able to tolerate oral medication, one valdecoxib 40 mg tablet was administered by mouth once daily in the morning until a maximum period of 7 days.
16297920|NCT00660842|Procedure|carboplatin|AUC 6 IV day 1 every 21 days
16297921|NCT00660842|Drug|paclitaxel|175 mg/m2 IV day 1 every 21 days
16297922|NCT00660842|Drug|carboplatin|AUC 2 IV every week
16297923|NCT00660842|Drug|paclitaxel|60mg/m2 IV every week
16297924|NCT00660829|Drug|Placebo|Placebo
16297925|NCT00660829|Drug|0.15% Azelastine Hydrochloride|0.15% Azelastine Hydrochloride 822 mcg
16297926|NCT00660816|Drug|erlotinib hydrochloride|Given orally once daily on days 2-19.
16297927|NCT00660816|Drug|pemetrexed disodium|Given IV over 10 minutes on day 1
16297928|NCT00660816|Drug|docetaxel|IV over 60 minutes on day 1.
16297929|NCT00660803|Drug|Fulvestrant|
16297930|NCT00660790|Other|Intensified Treatment of risk factors|Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
16297931|NCT00660777|Behavioral|Deep breathing, bilateral alternate chewing, nasal lavage|Deep breathing, bilateral alternate chewing, nasal lavage
16297932|NCT00660777|Behavioral|Oropharyngeal exercises|Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
16297933|NCT00660764|Drug|Rosuvastatin|Oral
16297934|NCT00660751|Drug|Duloxetine|SNRIs
16297935|NCT00660725|Drug|Vandetanib|Vandetanib is a pill that will be self-administered orally on Days 1-14 of each 14-day cycle. The dose of vandetanib each subject will receive will be determined by a dose escalation schedule (either 200 mg or 300 mg per day), which will be followed to determine the MTD of the study drug combination (vandetanib + GemOx). In the absence of disease progression, unacceptable toxicities, or other complications, the vandetanib and GemOx combination may continue per protocol for a maximum of 6 cycles, or 12 weeks. In subjects who show response or stable disease, vandetanib may be continued as a single agent beyond the 6 cycle maximum, at the investigator's discretion.
16297936|NCT00660725|Drug|Gemcitabine|30-minute IV infusion of 1000 mg/m^2 gemcitabine on Day 1 of each 14-day cycle.
16297937|NCT00660725|Drug|Oxaliplatin|Immediately following gemcitabine IV: 2-hour IV infusion of 85 mg/m^2 oxaliplatin on Day 1 of each 14-day cycle.
16297938|NCT00660699|Drug|Gemcitabine|
16297939|NCT00660699|Drug|Docetaxel|
16297940|NCT00660699|Radiation|Radiation|
16297941|NCT00660686|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
16297942|NCT00660686|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
16297943|NCT00660673|Drug|Levodopa-carbidopa intestinal gel|should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
16297944|NCT00660673|Device|CADD-Legacy® 1400 ambulatory infusion pump|pump
16297945|NCT00660660|Drug|Esomeprazole|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
16297946|NCT00660660|Drug|Placebo|once daily
16297947|NCT00660647|Drug|Adalimumab|Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
16297948|NCT00660647|Drug|Placebo|Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
16297949|NCT00660634|Procedure|Endovascular Revascularization|Angioplasty/Stenting of femoro-popliteal lesions
16297950|NCT00660621|Drug|Temozolomide and Bevacizumab|"Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week).
~No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week."
16297951|NCT00660595|Drug|Quetiapine|Oral administration
16297952|NCT00660595|Drug|Risperidone|Oral administration
16297953|NCT00660582|Drug|Cetuximab (Erbitux)|500 mg/m² every second week, intravenous infusion, 8 cycles
16297954|NCT00660582|Drug|Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid|Given in combination day 1 and 2, every second week, 8 cycles
16297955|NCT00660556|Device|Archimedes Constant Flow Pump & System|Pump implanted in abdomen with intrathecal delivery (catheter) for pain.
16297956|NCT00660543|Drug|Gadolinium|Given IV
16297957|NCT00660543|Drug|Ferumoxytol Non-Stoichiometric Magnetite|Given IV
16297958|NCT00660543|Other|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
16297959|NCT00660543|Other|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC MRI
16297960|NCT00660543|Other|Diffusion Weighted Imaging|Undergo DWI
16297962|NCT00660530|Drug|Lanthanum Carbonate Chewable Product|Lanthanum carbonate 1 g to be chewed, three times daily with meals
16297963|NCT00660530|Drug|Lanthanum carbonate crushed powder|Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal
16297964|NCT00660517|Drug|MP29-02|azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day
16297965|NCT00660517|Drug|azelastine Hcl|azelastine Hcl nasal spray one spray per nostril two times a day
16297966|NCT00660517|Drug|fluticasone propionate|fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day
16297967|NCT00660517|Drug|placebo|placebo nasal spray one spray per nostril two times a day
16297968|NCT00660504|Drug|Amrubicin Hydrochloride|Amrubicin Hydrochloride combined with cisplatin
16297969|NCT00660504|Drug|Etoposide-Cisplatin combined chemotherapy|combined chemotherapy
16297970|NCT00660491|Other|exercise training|moderate intensity exercise group, and high intensity exercise group
16297971|NCT00660478|Device|Endeavor|Comparison of two different drug eluting coronary stents
16297972|NCT00660478|Device|Cypher Select|Comparison of two different drug eluting coronary stents
16297973|NCT00660452|Drug|Staloral|Sublingual immunotherapy with Staloral dust mites solution
16297974|NCT00660439|Behavioral|Narrative Exposure Therapy|"Psychological treatment, with narration of positive and traumatic events in patients history, including in vivo exposure of traumatic events. The narrative is written down by the therapist."
16297975|NCT00660426|Drug|Oxaliplatin|
16297976|NCT00660426|Drug|Gemcitabine|
16297977|NCT00660426|Drug|Capecitabine|
16297978|NCT00660413|Device|TOF-Watch SX (Acceleromyography)|Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.
16297979|NCT00660400|Drug|5-azacitidine|Once enrolled, the patients will receive pre-transplant 5-azacitidine (Vidaza) 75 mg/M^2/day subcutaneously for 5-7 days every 28 days). Adjustments in dose and timing may occur based on clinical and hematological parameters.
16297980|NCT00660400|Procedure|Allogeneic Hematopoietic Cell Transplantation (HCT)|"Patients will receive transplantation if there is either a suitable sibling or an unrelated donor.
~Response will be evaluated by bone marrow biopsy after 4 cycles of 5-azacitidine or prior to HCT whichever comes first. Due to the very high risk of progression to AML or death in this patient population, the HCT will be done as soon as possible.
~The patients may have additional cycles of 5-azacitidine per standard hematology practice until scheduled for transplant or until progression of disease.
~All patients will be followed until time to progression of MDS, AML or death or a maximum of 1 year. For patients that are transplanted, follow up will be to one year post-transplant."
16297981|NCT00660387|Drug|Levodopa carbidopa intestinal gel (LCIG)|infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour)
16297982|NCT00660387|Drug|Placebo Gel|
16297983|NCT00660387|Drug|Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets|
16297984|NCT00660387|Drug|Placebo (PBO) oral capsules|
16297985|NCT00660387|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16297986|NCT00660387|Device|PEG tube|percutaneous endoscopic gastrostomy tube
16297987|NCT00660387|Device|J-tube|jejunal tube
16297988|NCT00660374|Drug|insulin NPH|"Soft-treat-to-target dose titration scheme, injection s.c."
16297989|NCT00660374|Drug|EX1000|"Soft-treat-to-target dose titration scheme, injection s.c."
16297990|NCT00660348|Drug|morphine sulfate|This is morphine given in the traditional methods.
16297991|NCT00660348|Device|Medtronic intrathecal pump|This pump will be inserted into the research subject and then the pump will deliver morphine.
16297992|NCT00660335|Drug|RG1068 (synthetic human secretin)|Single-dose, IV infusion
16297993|NCT00660322|Behavioral|Telephone Asthma Program|"The parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors:
~Using asthma controller medications as prescribed
~Having and Asthma Action Plan available to all who may need it.
~Using asthma rescue medications with the child's first symptoms.
~Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year."
16297994|NCT00660309|Drug|Aliskiren|Aliskiren 300 mg tablets
16297995|NCT00660309|Drug|Irbesartan|Irbesartan 300 mg tablets
16297996|NCT00660309|Drug|Captopril|Captopril 25 mg tablet
16297997|NCT00660296|Other|Air insufflation use in colonoscopy|Air insufflation for colonic distension
16297998|NCT00660296|Other|CO2 use in colonoscopy|Co2 insufflation for colonic distension
16297999|NCT00660283|Drug|Temozolomide|"(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery.
~7. (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles."
16298000|NCT00660270|Procedure|Pancreatic Surgery|
16298001|NCT00660270|Radiation|Radiation therapy|
16298002|NCT00660270|Drug|Cisplatin|
16298003|NCT00660270|Drug|5-FU|
16298004|NCT00660270|Drug|Alpha-interferon|
16298005|NCT00660270|Drug|Gemcitabine|
16298006|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
16298007|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
16298008|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
16298009|NCT00660257|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
16298010|NCT00660244|Drug|anastrozole|Oral
16298011|NCT00660231|Drug|bexarotene|Bexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated.
16298012|NCT00660231|Drug|gemcitabine hydrochloride|Gemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles.
16298013|NCT00660218|Drug|paclitaxel poliglumex|Phase I: 40 mg/m2 IV weekly in Cohort 1 (first 3 subjects), escalating in increments of 10 mg/m2 for Cohorts 2 through 5 (3 subjects each) until the maximum tolerated dose (up to 80 mg/m2 IV weekly) is established; Phase II: MTD mg/m2 IV weekly as established in Phase I (24 additional subjects)
16298014|NCT00660218|Biological|cetuximab|400 mg/m2 IV loading dose one week prior to starting other study treatments, then 250 mg/m2 IV weekly on same day as paclitaxel poliglumex
16298015|NCT00660218|Radiation|radiation therapy (IMRT or 3D-CRT)|radiation therapy to the head and neck, consisting of 33 daily fractions of 2.12 Gy for a total of 69.96 Gy, to begin the same day as paclitaxel poliglumex
16298016|NCT00660192|Drug|Botox|subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.
16298017|NCT00660192|Other|Placebo|subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.
16298018|NCT00660179|Drug|macitentan (ACT-064992)|Tablet, 3 mg dosage, once daily
16298019|NCT00660179|Drug|macitentan (ACT-064992)|Tablet, 10 mg dosage, once daily
16298020|NCT00660179|Drug|placebo|Matching placebo, once daily
16298021|NCT00660166|Biological|NK-Cell Infusion|The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
16298022|NCT00660153|Drug|Tivozanib (AV-951) plus FOLFOX6|"Investigational product, dosage and mode of administration (1 cycle = 4 weeks of treatment):
~Tivozanib (AV-951): 0.5 mg, 1.0 mg, and 1.5 mg oral once daily On Day -5 (± 2 days) subjects will receive a single dose of tivozanib (AV-951) for pharmacokinetic sampling. Beginning on Day 1 of Cycle 1, subjects will receive tivozanib (AV-951) once daily for 3 weeks followed by 1 week off. Tivozanib (AV-951) dosing repeats every cycle in the absence of disease progression or unacceptable toxicity. On days when both tivozanib (AV-951) and the FOLFOX6 chemotherapy regimen are co-administered, tivozanib (AV-951) will be administered immediately prior to the start of the FOLFOX6 chemotherapy regimen.
~Subjects will receive FOLFOX6 chemotherapy every 2 weeks starting on Day 1 of Cycle 1. Subjects will receive 2 treatments of FOLFOX6 in each treatment cycle, starting on Day 1 and Day 15."
16298023|NCT00660140|Drug|Gemcitabine|
16298024|NCT00660140|Drug|Carboplatin|
16298025|NCT00660101|Biological|OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine|OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
16298026|NCT00660088|Other|Ketasyn|10g for 7 days, 20g for 7 or 14 days
16298027|NCT00660075|Drug|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
16298028|NCT00660075|Drug|Placebo|Placebo for 6 weeks
16298029|NCT00660062|Drug|escitalopram|10 mg daily
16298030|NCT00660062|Drug|escitalopram|20 mg daily dosage
16298031|NCT00660062|Drug|escitalopram|30 mg daily dosage
16298032|NCT00660062|Drug|nortriptyline|100 mg daily dosage
16298033|NCT00660049|Device|SNaP Advanced Wound Care System|Application of negative pressure device daily per instructions
16298034|NCT00660049|Other|SNaP|Daily use
16298035|NCT00660049|Other|SNaP|Daily application per protocol
16298036|NCT00660036|Drug|Gemtuzumab ozogamicin|On Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m^2, 6 mg/m^2 or 9 mg/m^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.
16298037|NCT00660036|Drug|Mitoxantrone|On Days 1-3 of an inpatient hospital stay: 10 mg/m^2 administered via IVPB (intravenous piggy-back) in 50ml normal saline (NS) over 15 minutes
16298038|NCT00660036|Drug|Etoposide|On Days 1-5 of an inpatient hospital stay: 100 mg/m^2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours
16298039|NCT00660023|Drug|Methoxy polyethylene glycol-epoetin beta|Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
16298040|NCT00660010|Drug|Lupron (leuprolide acetate)|Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.
16298041|NCT00659997|Drug|Albendazole|Single oral dose of 400mg
16298042|NCT00659997|Drug|Levamisole|Single oral dose of 2.5mg/kg
16298043|NCT00659984|Drug|UltratraceTM Iobenguane I 131 Imaging|0.1 mCi/kg [3.7 MBq/kg] (minimum dose 1mCi [37MBq] but not to exceed 5 mCi [185 MBq]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must be started prior to the Ultratrace imaging dose. Anterior and posterior whole body images will be taken to assess organ distribution, tumor uptake and dosimetry calculations.
16298044|NCT00659984|Drug|UltratraceTM Iobenguane I 131 Therapy|Therapeutic dose will be given on Day 0 if dosimetry scans showed that the prescribed or adjusted dose will not exceed > 23 Gy to the kidneys, > 30 Gy to the liver, or > 15 Gy to the lungs. and tumor uptake confirmed with UltratraceTM imaging dose. Only one treatment course of therapeutic UltratraceTM will be given in this study.
16298045|NCT00659971|Drug|PAC113|PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days
16298046|NCT00659958|Drug|Zonisamide|300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.
16298047|NCT00659945|Drug|Aprepitant plus Ondansetron|Aprepitant plus Ondansetron
16298048|NCT00659945|Drug|Ondansetron plus placebo|Ondansetron plus placebo
16298102|NCT00659529|Drug|sildenafil|Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.
16298049|NCT00659932|Behavioral|Immediate Cognitive behavioural therapy (CBT)|The Dealing with Anxiety CBT Group Program comprises 7 group sessions: an initial five hour session followed by 6 three hour sessions over a three month period
16298050|NCT00659932|Behavioral|Delayed CBT|Commencement of the CBT Group Program is delayed 3 months
16298051|NCT00659919|Drug|Placebo|
16298052|NCT00659919|Drug|Trazodone|
16298053|NCT00659906|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
16298054|NCT00659906|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
16298055|NCT00659893|Drug|PEP005 Topical gel|0.05%, two day dose
16298056|NCT00659880|Other|BioCleanse Meniscus|Subjects will undergo routine meniscal allograft transplant surgery.
16298057|NCT00659867|Device|PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes|chromoscopy-guided endomicroscopy with targeted biopsies
16298058|NCT00659867|Device|PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes|Standard endoscopy with random and targeted biopsies
16298059|NCT00659854|Dietary Supplement|Non milk or soy based formula|Babies will be given a non milk or soy base formula for 12 weeks
16298060|NCT00659854|Dietary Supplement|milk based formula|Babies will be given a milk based formula for 12 weeks
16298061|NCT00659841|Drug|Ciclesonide|200µg Ciclesonide versus placebo
16298062|NCT00659841|Drug|Placebo|placebo
16298063|NCT00659828|Drug|Recombinant methionyl human leptin|Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
16298064|NCT00659815|Device|Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.|Daily care for contact lenses.
16298065|NCT00659815|Device|Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.|Daily care for contact lenses
16298066|NCT00659802|Drug|HMPL-004 low dose|HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
16298067|NCT00659802|Drug|Placebo|Matching dose of Placebo
16298068|NCT00659802|Drug|HMPL-004 high dose|HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
16298069|NCT00659789|Drug|Vacc-4x|Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
16298070|NCT00659789|Drug|Sterile water|Sterile water is used in place of Vacc-4x and in place of Leukine
16298071|NCT00659776|Drug|Ferumoxytol|Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
16298072|NCT00659763|Other|Exclusion diagnosis|"Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test.
~3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy"
16298073|NCT00659763|Other|Clinical diagnosis|Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
16298074|NCT00659750|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
16298075|NCT00659750|Drug|Placebo|placebo
16298076|NCT00659737|Drug|Aprepitant|40mg tablet
16298077|NCT00659737|Drug|Scopolamine|1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
16298078|NCT00659711|Drug|Januvia (Sitagliptin) 100 mg|The first group will be started on 100 mg sitagliptin daily for 12 weeks
16298079|NCT00659711|Drug|Placebo|will be placed on a placebo for 12 weeks.
16298080|NCT00659698|Device|the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)|artificial pancreas
16298081|NCT00659685|Drug|Ondansetron|ODT, single-dose, fasting
16298082|NCT00659685|Drug|Zofran ODT|
16298083|NCT00659672|Dietary Supplement|Whey Protein|40 grams per day Whey Protein
16298084|NCT00659672|Dietary Supplement|Soy Protein|40 grams per day soy protein
16298085|NCT00659672|Dietary Supplement|Control (carbohydrate)|40 grams per day maltodextrin
16298086|NCT00659659|Drug|MEDI-563|1.0 mg/kg IV: MEDI-563
16298087|NCT00659659|Drug|MEDI-563|100 mg, 200 mg SC
16298088|NCT00659659|Other|Placebo Comp.|Placebo SC
16298089|NCT00659659|Other|Placebo|Placebo as a single IV infusion (Certain number of subjects)
16298090|NCT00659646|Drug|gentamicin-collagen sponge and levofloxacin|Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.
16298091|NCT00659646|Drug|Levofloxacin only|levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
16298092|NCT00659633|Drug|lidocaine|intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once
16298093|NCT00659620|Biological|mesenchymal stem cell|transplantation of mesenchymal stem cell
16298094|NCT00659594|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
16298095|NCT00659594|Drug|Placebo|placebo
16298096|NCT00659581|Drug|Telmisartan|Oral administration
16298097|NCT00659568|Drug|metformin hydrochloride|
16298098|NCT00659568|Drug|temsirolimus|
16298099|NCT00659555|Drug|pazopanib eye drops|Pazopanib will be administered as eye drop solution via topical ocular route. Pazopanib eye drops will be available as white, colorless solution.
16298100|NCT00659555|Drug|Ketoconozole tablets|Ketoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets
16298101|NCT00659542|Procedure|cyanoacrylate glue|1 ml glue
16298103|NCT00659503|Drug|Ciclesonide|200µg Ciclesonide versus Placebo
16298109|NCT00659451|Drug|Losartan|tablets; 50, 100 mg; od; 12 months
16298110|NCT00659451|Drug|Amlodipine|tablets; 5, 10 mg; od; 12 months
16298111|NCT00659438|Drug|ZD6474 (Vandetanib)|300mg orally, once daily
16298112|NCT00659438|Drug|Bicalutamide|150mg orally, once daily
16298113|NCT00659438|Drug|Placebo|orally, once daily
16298114|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298115|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298116|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298117|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298118|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298119|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298120|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298121|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
16298122|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
16298123|NCT00659425|Drug|CAT-8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
16298124|NCT00659412|Drug|Alefacept|Intramuscular
16298125|NCT00659412|Drug|Methotrexate|Oral
16298126|NCT00659412|Drug|Placebo|Intramuscular
16298127|NCT00659399|Drug|Fondaparinux|Arixtra 2.5 mg by subcutaneous injection once daily for 8 weeks or until disease recurrence or grade 3, 4 adverse events.
16298128|NCT00659386|Drug|Intravenous immunoglobulin therapy|Patients received total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 3 consecutive days.
16298129|NCT00659373|Drug|Tamoxifen|
16298130|NCT00659373|Drug|triptorelin|
16298131|NCT00659373|Drug|Exemestane|
16298132|NCT00659360|Drug|saracatinib|Given orally
16298133|NCT00659347|Drug|DOV 21, 947|Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks
16298134|NCT00659347|Drug|Placebo|Capsules,25 mg,BID,6weeks
16298135|NCT00659334|Drug|Ferumoxtran-10 (Combidex)|2.6 mg/kg
16298136|NCT00659334|Procedure|Neurosurgery|neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.
16298137|NCT00659321|Drug|nicotine acid|16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
16298138|NCT00659321|Drug|placebo|16 weeks treatment with placebo
16298139|NCT00659308|Procedure|amniotic membrane transplantation|patients are submitted to amniotic membrane transplantation
16298140|NCT00659308|Procedure|anterior stromal puncture|the other group is submitted to anterior stromal puncture
16298141|NCT00659295|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
16298142|NCT00659282|Drug|biphasic insulin aspart|Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
16298143|NCT00659269|Dietary Supplement|Multivitamin (MV)|Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
16298144|NCT00659269|Dietary Supplement|Multivitamin + Vitamin B12 + Vitamin B6|Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections
16298145|NCT00659269|Drug|Chemotherapy|"Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)
~Ranges of cumulative doses (in mg/m2) are:
~paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800"
16298146|NCT00659243|Drug|rhBSSL|0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment
16298147|NCT00659243|Drug|Placebo|One week treatment
16298148|NCT00659230|Drug|Nepicastat|100-800mg
16298149|NCT00659230|Drug|Placebo|100-800mg placebo
16298150|NCT00659217|Biological|mesenchymal stem cell|Autologous MSC transplantation
16298151|NCT00659204|Drug|nano-silver gel exposed|SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes
16298152|NCT00659204|Drug|alcohol-based hand gel|Purell gel applied topically to the hands with a limited exposure time of 10 minutes
16298153|NCT00659191|Drug|GSK1265744|
16298154|NCT00659178|Drug|SB-485232 (interleukin 18), pegylated liposomal doxorubicin|SB-485232 (interleukin 18), pegylated liposomal doxorubicin
16298155|NCT00659165|Drug|Insulin Detemir|Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.
16298156|NCT00659165|Drug|Insulin Glargine|Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.
16298157|NCT00659126|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo 3T MRI
16298158|NCT00659126|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
16298159|NCT00659126|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC MRI
16298160|NCT00659126|Drug|Ferumoxytol|Given IV
16298161|NCT00659126|Drug|Gadolinium|Given IV
16298162|NCT00659126|Procedure|High Field Strength Magnetic Resonance Imaging|Undergo 7T MRI
16298163|NCT00659126|Procedure|Susceptibility Weighted Imaging|Undergo SWI
16298164|NCT00659113|Drug|cisplatin|
16298165|NCT00659113|Drug|tegafur-gimeracil-oteracil potassium|
16298166|NCT00659113|Other|cytology specimen collection procedure|
16298167|NCT00659113|Procedure|endoscopic biopsy|
16298168|NCT00659100|Drug|Gabapentin|Gabapentin 50 mg oral capsule 30 minutes before bedtime
16298169|NCT00659087|Procedure|Femoral Block|Those receiving femoral block postoperatively
16298170|NCT00659087|Other|Usual Care|Those receiving only usual pain management postoperatively
16298171|NCT00659074|Drug|Ondansetron|ODT, single-dose, fasting
16298172|NCT00659074|Drug|Zofran|ODT, single-dose, fasting
16298173|NCT00659061|Dietary Supplement|SPRINKLES|"Sprinkles is a multiple micronutrient fortificant. It is packed as a single serving sachets each containing micro encapsulated iron (12.5 mg), zinc (7.5 mg), vitamin C (30 mg), vitamin A (300 µg), vitamin D (5 µg), folic acid (150 µg) and iodine (90µg).
~Two month supply of the Sprinkle sachet along with advice on its benefits as well as its appropriate use will be given by the LHWs. The LHWs will also provide their age-appropriate nutritional advice as per their regular door to door community services."
16298174|NCT00659061|Behavioral|Nutrition education|Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
16298175|NCT00659048|Drug|Ciclesonide|Ciclesonide 200µg versus Placebo
16298176|NCT00659048|Drug|Placebo|placebo
16298177|NCT00659022|Procedure|immediate surgery (resection of primary colorectal tumor)|no neo-adjuvant treatment, immediate surgery
16298178|NCT00659022|Drug|neo-adjuvant treatment with bevacizumab|neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary
16298179|NCT00659022|Drug|neoadjuvant treatment with capecitabine and oxaliplatin|neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary
16298180|NCT00659022|Drug|neo-adjuvant treatment with bevacizumab, capecitabine and oxaliplatin|neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary
16298181|NCT00659009|Other|Reduced barometric pressure|Sleep in reduced barometric pressure environment.
16298182|NCT00659009|Other|Sea level equivalent barometric pressure|Sleep in barometric pressure equivalent to sea level.
16298183|NCT00659009|Other|Reduced barometric pressure|Sleep in reduced barometric pressure environment.
16298184|NCT00658996|Device|SofLens DD Toric|daily disposable wear contact lens for 2 weeks
16298185|NCT00658996|Device|Ciba Vision Focus Dailies Toric Contact Lens|daily disposable wear contact lens for 2 weeks
16298186|NCT00658983|Other|Autologous Platelet Enriched Gel|Treatment with Autologous Platelet Enriched Gel
16298187|NCT00658983|Other|Metalloproteinase Inhibitor|Treatment with Metalloproteinase Inhibitor (Promogran)
16298188|NCT00658970|Drug|KX2-391|2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops
16298189|NCT00658957|Drug|gentamicin-collagen sponge|5 × 5 cm sponge
16298190|NCT00658957|Drug|placebo collagen sponge|5 × 5 cm sponge
16298191|NCT00658931|Drug|Drug treatment with Cymbalta|Drug treatment with Cymbalta
16298192|NCT00658918|Drug|Ciclesonide nasal|safety of Ciclesonide (200µg, 100µg, 25µg)
16298193|NCT00658918|Drug|Placebo|placebo
16298194|NCT00658905|Drug|rhBSSL|0.15 g/L rhBSSL added to infant formula; one week treatment
16298195|NCT00658905|Drug|Placebo|One week treatment
16298196|NCT00658892|Biological|B7-DC cross-linking antibody rHIgM12B7|
16298197|NCT00658892|Other|flow cytometry|
16298198|NCT00658892|Other|immunologic technique|
16298199|NCT00658892|Other|laboratory biomarker analysis|
16298200|NCT00658879|Drug|Somavert (Pegvisomant)|"Somavert (Pegvisomant) 10, 15 or 20mg powder and solvent for solution for injection.
~Dosage, Frequency : According to Japanese LPD.
~Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration."
16298201|NCT00658866|Procedure|Microdialysis|PK measurements with microdialysis
16298202|NCT00658853|Behavioral|4 times 4 minutes high aerobic intensity one leg cycling|3 times per week for 10 weeks
16298203|NCT00658840|Drug|Capecitabine (Xeloda®)|Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).
16298204|NCT00658840|Radiation|Localization, simulation and immobilization|"Radiation dose and planning
~Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm.
~Dose prescription : 90% isodose volume of prescribed dose encompassed PTV
~The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated."
16298205|NCT00658827|Other|No intervention|This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.
16298206|NCT00658814|Drug|Azacitidine|Given IV or SC during induction; given SC during consolidation and maintenance
16298207|NCT00658814|Drug|Gemtuzumab Ozogamicin|Given IV
16298208|NCT00658801|Radiation|Respiratory gated proton beam radiotherapy|"Prescription dose to PTV as according to the following dose escalation schema:
~Group 1: Tumor size ≤5cm Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.
~Group 2: 5cm <Tumor size ≤10cm Dose level 1: 54 GyE /18 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week."
16298209|NCT00658788|Drug|clobetasol propionate spray 0.05%|clobetasol propionate spray, 0.05%, applied topically twice daily
16298210|NCT00658788|Drug|calcitriol ointment|calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
16298211|NCT00658775|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
16298212|NCT00658775|Drug|Esomeprazole|Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
16298213|NCT00658762|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
16298214|NCT00658762|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
16298215|NCT00658762|Drug|paroxetine|Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
16298216|NCT00658762|Drug|Placebo|Capsules, oral, BID, 8 weeks, with 2 week taper
16298217|NCT00658749|Drug|AIR645|AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
16298218|NCT00658749|Drug|Physiologic saline solution|Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
16298219|NCT00658736|Drug|Triamcinolone|Injection of bupivacaine and triamcinolone
16298220|NCT00658736|Drug|Bupivicaine alone|Injection of bupivacaine
16298221|NCT00658723|Drug|Fibrin Pad|Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
16298222|NCT00658723|Device|SURGICEL™|Absorbable hemostat
16298223|NCT00658710|Behavioral|physical therapy sessions|two physical therapy sessions per week for two months
16298224|NCT00658697|Drug|Docetaxel|Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
16298225|NCT00658697|Drug|Bevacizumab|Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
16298226|NCT00658697|Drug|ADT|Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
16298227|NCT00658697|Drug|Bicalutamide|Starting on day 84 orally once daily until hormone therapy is completed
16298228|NCT00658684|Drug|fesoterodine fumarate|4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
16298229|NCT00658671|Drug|ENMD-2076|Capsules, daily dosing in 28 day cycles
16298230|NCT00658658|Biological|Panitumumab|Panitumumab administered by intravenous infusion
16298231|NCT00658645|Drug|Bifeprunox|20 mg daily, encapsulated tablets, orally, 12 months
16298232|NCT00658645|Drug|Placebo|Encapsulated tablets, orally, 12 weeks
16298233|NCT00658645|Drug|Quetiapine|600 mg daily, encapsulated tablets, orally, 12 months
16298234|NCT00658632|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
16298235|NCT00658632|Drug|Esomeprazole|Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
16298236|NCT00658619|Drug|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
16298237|NCT00658619|Drug|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
16298238|NCT00658619|Other|Sham (no implant)|Sham in one or both eyes on Day 1 and Month 6.
16298239|NCT00658606|Drug|alefacept|IM
16298240|NCT00658606|Procedure|Narrow Band UVB Phototherapy|UVB Phototherapy
16298241|NCT00658593|Drug|capecitabine|
16298242|NCT00658593|Drug|gemcitabine hydrochloride|
16298243|NCT00658593|Procedure|quality-of-life assessment|
16298244|NCT00658580|Drug|Cisplatin + etoposide|"Cisplatin 90 mg/m² day 1, every 3 weeks
~Etoposide 100 mg/m² days 1-3, every 3 weeks"
16298245|NCT00658580|Drug|Epirubicin + ifosfamide + etoposide|"Epirubicin 60 mg/m² day 1, every 3 weeks
~Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks
~Etoposide 100 mg/m² days 1-3, every 3 weeks"
16298246|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|10 mg, tablet, once daily by mouth, for six weeks
16298247|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|20 mg, tablet, once daily by mouth, for six weeks
16298248|NCT00658567|Drug|Pimavanserin tartrate (ACP-103)|Placebo, tablet, once daily by mouth, for six weeks
16298249|NCT00658554|Drug|ARQ 197|Treatment with ARQ 197
16298250|NCT00658541|Drug|Zolpidem Tartrate 10 mg tablet|10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
16298251|NCT00658541|Drug|Zolpidem Tartrate 10 mg tablet (Ambien®)|10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
16298252|NCT00658528|Drug|Rabeprazole sodium|Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
16298253|NCT00658528|Drug|Esomeprazole|Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
16298254|NCT00658515|Drug|Dalcetrapib (RO4607381)|600mg po daily
16298255|NCT00658515|Drug|Evidence-based medical care for Acute Coronary Syndrome|As prescribed
16298256|NCT00658515|Drug|Placebo|po daily
16298257|NCT00658489|Behavioral|Education|One group of residents will receive extensive web-based training in the promotion of oral health. The second group of residents will complete a single training module in the prevention of iron deficiency. The third arm consists of parent-child dyads, who will participate in one well-child care visit.
16298258|NCT00658476|Dietary Supplement|Fish Oil|Omega-3 fatty acid supplements.
16298259|NCT00658476|Behavioral|Cognitive Behavior Therapy|Adolescents receive cognitive behavior therapy.
16298260|NCT00658476|Other|Placebo|
16298261|NCT00658463|Drug|Rosuvastatin|rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design
16298262|NCT00658463|Drug|Placebo|Placebo
16298308|NCT00658086|Drug|ALN-RSV01|administered by nebulization once daily for 3 days
16298309|NCT00658086|Drug|normal saline|administered by nebulization once daily for 3 days
16298359|NCT00657735|Device|sham|inactive treatment
16298263|NCT00658450|Behavioral|Cognitive rehabilitation training|"A computerised cognitive training package where children will be required to complete several cognitive tasks. The aim is to strengthen the different cognitive processes during these tasks which in turn may lead to improve cognitive processes.
~Children will complete these tasks in 16 session for 8 weeks."
16298264|NCT00658437|Drug|CY-503|solution for subcutaneous injection, 350 ng twice weekly
16298265|NCT00658411|Drug|deferoxamine|Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.
16298266|NCT00658398|Behavioral|Interactive Computer Program to prevent alcohol misuse.|Interactive Computer Program with questionnaires, video and informations
16298267|NCT00658385|Genetic|GCSF, Central venous line placement, Stem cell Collection (leukapheresis)|"Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.
~These will be done again 24 hours after your stem cells are collected."
16298268|NCT00658372|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
16298269|NCT00658372|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
16298270|NCT00658372|Drug|Paroxetine|Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
16298271|NCT00658372|Drug|Placebo|Capsules, oral, placebo, BID, 8 weeks with 2 week taper
16298272|NCT00658359|Drug|Cyclosporine|Standard of care
16298273|NCT00658359|Drug|CP-690,550|CP-690,550 tablets dosed BID Months 12-72
16298274|NCT00658359|Drug|CP-690,550|CP-690,550 tablets dosed BID Months 12-72
16298275|NCT00658346|Drug|Treatment initiation for HIV-1 group O infected patients|"The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
~If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
~If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
~If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)"
16298276|NCT00658346|Drug|Treatment initiation for HIV-1 group M infected patients|"The first line regimen is adapted according to the hemoglobin level and the AgHBs status :
~If Hb > 8 g/ml and negative AgHBs : AZT-3TC (DUOVIR) + LPV/RTV (ALUVIA)
~If Hb <= 8 g/ml and negative AgHBs : TDF-3TC (LAMIVIR-S) + LPV/RTV (ALUVIA)
~If positive AgHBs : TDF + 3TC + LPV/RTV (ALUVIA)"
16298277|NCT00658333|Drug|Enteric-coated Mycophenolate Acid (EC-MPA)|
16298278|NCT00658333|Drug|Mycophenolate Mofetil (MMF)|
16298279|NCT00658333|Drug|Placebo MMF|
16298280|NCT00658333|Drug|Placebo EC-MPA|
16298281|NCT00658320|Drug|Everolimus|0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.
16298282|NCT00658320|Drug|Mycophenolate mofetil (MMF)|The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.
16298283|NCT00658320|Drug|Basiliximab|Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice
16298284|NCT00658320|Drug|Cyclosporine A|The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.
16298285|NCT00658320|Drug|Corticosteroid|Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study
16298286|NCT00658307|Device|repetitive transcranial magnetic stimulation (rTMS)|"1 Hz
~The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
16298287|NCT00658307|Device|repetitive transcranial magnetic stimulation (rTMS)|"20Hz
~The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
16298288|NCT00658307|Device|sham repetitive transcranial magnetic stimulation (rTMS)|"The rTMS device is the MagPro X100 Series (produced by Magventure A/S, Farum, Denmark)"
16298289|NCT00658294|Other|Stop treatment|
16298290|NCT00658281|Procedure|CBCT Scan|Cone Beam Computed Tomography (CBCT) scan performed once a week.
16298291|NCT00658281|Procedure|OBI KV Imaging|On Board Imager kilovoltage (OBI KV) Imaging performed once a week.
16298292|NCT00658268|Drug|Clodronate|60 mg/ml, 10 ml, single dose mixed in bone graft at operation
16298293|NCT00658268|Drug|Placebo|10 ml, single dose mixed in bone graft at operation
16298294|NCT00658255|Drug|budesonide/formoterol|
16298295|NCT00658255|Drug|formoterol|
16298296|NCT00658229|Behavioral|Strength training group|After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).
16298297|NCT00658203|Device|New Living CHF|PEA CRT optimization
16298298|NCT00658203|Device|New Living CHF|Standard optimized CRT.
16298299|NCT00658177|Drug|Levitra (Vardenafil, BAY38-9456)|20mg to be taken 1 h prior to sexual intercourse
16298300|NCT00658177|Drug|Placebo|Matching placebo
16298301|NCT00658164|Other|Iron depletion treatment|Effect of iron depletion by phlebotomy plus lifestyle changes vs. lifestyle changes alone on liver damage in patients with nonalcoholic fatty liver disease with increased iron stores
16298302|NCT00658138|Device|3M ESPE Adper Scotchbond SE|To be used per manufacturer's instructions.
16298303|NCT00658138|Device|3M ESPE Adper Scotchbond 1XT|To be used per manufacturer's instructions.
16298304|NCT00658125|Procedure|Bilateral fornix DBS implantation,|Fornix DBS for Alzheimer Disease
16298305|NCT00658112|Drug|Benzoyl Peroxide|Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
16298306|NCT00658099|Drug|insulin detemir|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
16298307|NCT00658099|Drug|insulin NPH|Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
16298310|NCT00658073|Procedure|Kidney transplantation with MSCs infusion|Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
16298311|NCT00658073|Procedure|kidney transplantation without MSC infusion|kidney transplantation with standard immunosuppressive treatment regime
16298312|NCT00658047|Drug|CH-1504|Comparison of different doses of CH-1504
16298313|NCT00658047|Drug|Methotrexate (MTX)|10mg/week for 2 weeks escalated to 15mg/week for 2 weeks escalated to 20mg/week for 8 weeks
16298314|NCT00658034|Procedure|Acupuncture|Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.
16298315|NCT00658034|Procedure|Placebo Acupuncture|"Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted.
~Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture."
16298316|NCT00658021|Drug|Placebo|Subcutaneous injection, twice a day
16298317|NCT00658021|Drug|Exenatide|Subcutaneous injection, 5 µg, twice a day
16298318|NCT00658021|Drug|Exenatide|Subcutaneous injection,10 µg, twice a day
16298319|NCT00658008|Drug|PD 0332334|Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
16298320|NCT00658008|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
16298321|NCT00658008|Drug|PD 0332334|Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
16298322|NCT00658008|Drug|Paroxetine|Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
16298323|NCT00658008|Drug|Placebo|Capsules, oral, placebo bid, 8 weeks with 2 week taper
16298324|NCT00657995|Device|Artificial Pancreas (STG-22)|safe tool
16298325|NCT00657982|Drug|RAD001|10mg BID
16298326|NCT00657956|Device|Advance Biofoam porous metal backed tibial component with or without screw augmentation|total knee arthroplasty tibial component that has a backing of porous titanium metal to facilitate bone in-growth
16298327|NCT00657943|Drug|metformin|metformin tablets 2 g x 2
16298328|NCT00657943|Drug|insulin detemir|insulin as requested
16298329|NCT00657943|Drug|insulin aspart + insulin aspart protamin|insulin as requested
16298330|NCT00657943|Drug|Insulin aspart|insulin as requested
16298331|NCT00657930|Drug|insulin detemir|observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
16298332|NCT00657917|Drug|Paromomycin +Gentamicin topical cream|WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
16298333|NCT00657904|Drug|Bicalutamide|150mg daily
16298334|NCT00657904|Drug|Placebo|once daily
16298335|NCT00657891|Drug|Omalizumab|0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
16298336|NCT00657891|Drug|Placebo|Placebo Injection
16298337|NCT00657878|Drug|stealth liposomal doxorubicin|stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
16298338|NCT00657878|Drug|carboplatin|carboplatin AUC 5 IV day 1 every 21 days
16298339|NCT00657878|Drug|paclitaxel|paclitaxel 175 mg/m2 IV day 1 every 21 days
16298340|NCT00657878|Drug|Topotecan|dosing and schedule according to Institutional guidelines
16298341|NCT00657878|Drug|Gemcitabine|1000 mg/m2 on days 1,8,15 every 28 days
16298342|NCT00657865|Drug|ramipril|oral intake
16298343|NCT00657865|Drug|placebo|placebo
16298344|NCT00657852|Drug|Disodium pamidronate|Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion
16298345|NCT00657852|Drug|Placebo|500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion
16298346|NCT00657839|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg Vardenafil bid
16298347|NCT00657839|Drug|Placebo|Matching placebo
16298348|NCT00657826|Device|ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm|Isolated aortic valve replacement with a size 19mm valve
16298349|NCT00657813|Drug|MNI-330 as a brain SPECT tracer of Beta-Amyloid|Each subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs.
16298350|NCT00657800|Behavioral|Intensified inpatient diabetes education program (IDEP)|Assessment of educational needs and coordination of inpatient unit based education program by Certified Diabetes Educator (CDE)
16298351|NCT00657774|Drug|FlutiForm 250/10 ug|SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
16298352|NCT00657774|Drug|FlutiForm 100/10 ug|SKP FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.
16298353|NCT00657774|Drug|Oral Prednisone 10mg|2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.
16298354|NCT00657774|Drug|Placebo|2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.
16298355|NCT00657761|Drug|Enfuvirtide|90 mg/12h sc for 7 days
16298356|NCT00657761|Drug|Placebo|0.9% saline solution/12h sc for 7 days
16298357|NCT00657748|Drug|Lithium Gluconate (drug) Glyceryl Triacetate GTA (drug)|Lithium 1.3 mEq/kg/day (three administrations a day)during the study GTA 500 mg/kg/day in four administrations a day during the study
16298358|NCT00657735|Device|H-Coil deep TMS|20 daily deep rTMS treatments
16298360|NCT00657722|Other|Angiography and Computed Tomography|Preoperative angiography and Computed Tomography
16298361|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)|One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
16298362|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)|One dose of rMenB concomitantly with the routinely administered infant vaccines
16298363|NCT00657709|Biological|Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)|One dose of rMenB concomitantly with the routinely administered infant vaccines
16298364|NCT00657709|Biological|Infanrix Hexa|Routine vaccination
16298365|NCT00657709|Biological|Menjugate|One dose of the routinely administered infant vaccines + MenC vaccine
16298366|NCT00657709|Biological|Prevenar|Routine vaccination
16298367|NCT00657683|Biological|Monovalent GBS-CRM glycoconjugate vaccine|1 dose of GBS conjugate vaccine
16298368|NCT00657683|Biological|Placebo|1 dose of placebo
16298369|NCT00657670|Device|Ready-made spectacles|Ready-made spectacles will be dispensed to correct refractive error. Ready-made spectacles are spectacles which are available from an existing inventory. This is different to prescription spectacles which are usually made to order. They have the same spherical power for the right and left eyes and do not include a correction for astigmatism. The limited inventory for this trial includes +1.00 to +4.00 in 0.50 steps, +5.00, +6.00 and +8.00, -1.00 to -6.00 in 0.50 steps, -7.00, -8.00, -9.00 and -10.00. The appropriate spectacles are selected based on the spherical equivalent refractive error. If there is a difference between the two eyes the lower correction is selected.
16298370|NCT00657670|Device|Spectacles|Spectacles will be prescribed to correct refractive error. These spectacles will be custom-prescribed based on the sphero-cylindrical refractive correction. The spectacles used in this arm will be custom made for each participant based on their refraction and can be made in a full range of spherical powers and astigmatic corrections for up to 2.00 dioptres of cylinder.
16298371|NCT00657657|Biological|Engerix™-B|A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.
16298372|NCT00657644|Drug|Levitra (Vardenafil, BAY38-9456)|4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
16298373|NCT00657631|Behavioral|Acceptance and Commitment Therapy|"Considered part of the third wave of CBT along with Dialectical Behavior Therapy (DBT; Linehan, 1993) and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale, 2001), ACT is built upon the strong, research-based foundation of CBT. However, while CBT for psychosis focuses on reducing symptoms, ACT focuses on changing the way in which the person experiences his or her symptoms so that the person can still live his or her life in accordance with his or her life values. Specifically, CBT attempts to reduce delusions by disputing the evidence for the delusion and ACT attempts to increase the person's ability to live his or her life while still experiencing delusions (Hayes, Strosahl & Wilson, 1999)."
16298374|NCT00657618|Drug|Sodium Stibogluconate (SSG)|100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
16298375|NCT00657605|Drug|Recombinant methionyl human leptin|Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
16298376|NCT00657579|Drug|DE-104 ophthalmic solution, low concentration|
16298377|NCT00657579|Drug|DE-104 ophthalmic solution, medium concentration|
16298378|NCT00657579|Drug|DE-104 ophthalmic solution, high concentration|
16298379|NCT00657579|Drug|DE-104 vehicle|
16298380|NCT00657566|Other|duration of antibiotics|4 +/- 1 days of antibiotics
16298381|NCT00657566|Other|duration of antibiotics|active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
16298382|NCT00657553|Drug|Bortezomib|Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks
16298383|NCT00657540|Drug|Analatro|30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses
16298384|NCT00657540|Drug|Saline|50 mL of saline infused over 10 minutes
16298385|NCT00657527|Drug|Rosuvastatin|
16298386|NCT00657527|Behavioral|Cholesterol lowering diet|
16298387|NCT00657514|Drug|Ranolazine|500mg tablet po bid up to 1000mg (2 500mg tablets) po bid
16298388|NCT00657514|Drug|Placebo|1 tablet po bid up to 2 tablets po bid if tolerated
16298389|NCT00657501|Drug|testosterone gel|once daily transdermal gel, 300 mcg
16298390|NCT00657501|Drug|placebo gel|once daily transdermal placebo gel
16298391|NCT00657488|Drug|Thalidomide|Thalidomide 100mg/day or 400 mg/day at bed time during one year
16298392|NCT00657475|Drug|Heparin Low Dose|Loading heparin dose of 150 IU / kg to achieve an ACT (activating clotting time) target more than 240 seconds.
16298393|NCT00657475|Drug|Heparin Full Dose|Loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds.
16298394|NCT00657462|Other|Reminders|Users of the PAML Builder application will receive reminders about three application features (copy/paste, audit trail, sort medications by class) at the startup of the application
16298395|NCT00657449|Drug|valdecoxib|valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
16298396|NCT00657449|Drug|rofecoxib|rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
16298397|NCT00657423|Drug|Treated by endostar combined with docetaxel and cisplatin|recombinant human endostatin given intravenously,7.5mg/㎡,d1-14,2cycles. docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
16298398|NCT00657423|Drug|Treated by docetaxel and cisplatin|docetaxel given intravenously,75mg/㎡,d1,2cycles. cisplatin given intravenously,75mg/㎡,d1,2cycles.
16298399|NCT00657410|Drug|dexamethasone|
16298400|NCT00657410|Drug|prednisone|
16298401|NCT00657410|Procedure|quality-of-life assessment|
16298402|NCT00657397|Drug|Methadone|Methadone sirup once daily
16298488|NCT00656695|Drug|Neoral|Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
16298403|NCT00657384|Drug|acid tranexamic|10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.
16298404|NCT00657384|Drug|Nacl 0.9%|10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention
16298405|NCT00657371|Device|Third Eye Retroscope Auxiliary Imaging System|A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
16298406|NCT00657358|Drug|Lidocaine|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
16298407|NCT00657332|Procedure|blood sample draw|
16298408|NCT00657332|Procedure|urine sample|
16298409|NCT00657319|Drug|biphasic insulin aspart 30|The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.
16298410|NCT00657306|Drug|hydrocortisone|50 mg/6 h per day
16298411|NCT00657306|Drug|dextrose solution 5%|dextrose solution 5% 100 ml/6 h per day
16298412|NCT00657293|Behavioral|Arm training program|Patients will undergo a specific arm training program (ATP) three times a week for the duration of the 6 week program. The ATP will consist predominantly of resistance exercises. Muscle groups targeted during the ATP will include deltoid, biceps and triceps, pectoralis and latissimus. Subjects will train using multi station gym equipment and free weights.
16298413|NCT00657293|Behavioral|Purdue pegboard test (sham)|In an attempt to make the groups comparable in terms of attention, the control group will perform the purdue pegboard test of finger dexterity. The tasks will be performed in a sitting position with the arms supported on a table. This test will consist of 4 timed tasks where as many pins as possible will be placed on a pegboard in a given time. Performance of the pegboard test is likely to improve with practice which may serve to motivate the patients to continue practicing over the 6-week period. Subjects will perform this activity 3 times per week with supervision provided by a physiotherapist.
16298414|NCT00657280|Drug|Sitagliptin|No one is blinded to the treatments.
16298415|NCT00657267|Drug|Temozolomide|Taken orally daily for the first three weeks of a four-week cycle.
16298416|NCT00657254|Drug|Nexavar (Sorafenib, BAY43-9006)|Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.
16298417|NCT00657241|Drug|carvedilol|Coreg CR 20 mg (one week) and Coreg CR 40 mg (3 weeks).
16298418|NCT00657241|Drug|valsartan|Valsartan 160 mg (one week); valsartan 320 mg (3 weeks)
16298419|NCT00657228|Drug|Intravenous heparin|"Intravenous heparin as an adjunct for the treatment of anaphylactic/anaphylactoid reactions in the Emergency Department.
~To determine if a single bolus of intravenous unfractionated heparin (in conjunction with standard therapy) given to patients with anaphylactic/anaphylactoid reactions results in a faster time to recovery when compared to standard therapy alone."
16298420|NCT00657228|Drug|Saline|Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
16298421|NCT00657202|Drug|Ranibizumab|Given as an injection into three cutaneous neurofibromas on day 1 of the study treatment.
16298422|NCT00657189|Drug|MEDI-545|100 mg once; SC Placebo × 12 doses on other weeks
16298423|NCT00657189|Drug|MEDI-545|100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
16298424|NCT00657189|Drug|MEDI-545|100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
16298425|NCT00657189|Drug|MEDI-545|100 mg every week × 13 doses
16298426|NCT00657189|Drug|Placebo|SC Placebo every week × 13 doses
16298427|NCT00657176|Drug|OPB-31121|"100mg tablet
~oral administration, Qd"
16298428|NCT00657163|Drug|fluoxetine|fluoxetine per os 20 mg daily
16298429|NCT00657163|Drug|placebo|placebo per os daily
16298430|NCT00657150|Drug|Enoxaparin|40 mg once daily
16298431|NCT00657150|Drug|Dabigatran etexilate|220 mg once daily
16298432|NCT00657137|Drug|apricoxib + lapatinib + capecitabine|"apricoxib: 100 mg tablets, 400 mg/day
~lapatinib: per package insert
~capecitabine: per package insert"
16298433|NCT00657137|Drug|placebo + lapatinib + capecitabine|"placebo: 100 mg tablets, 400 mg/day
~lapatinib: per package insert
~capecitabine: per package insert"
16298434|NCT00657124|Dietary Supplement|Aminolevan EN|The present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance.
16298435|NCT00657124|Dietary Supplement|Placebo|placebo
16298436|NCT00657111|Drug|CS-8958 formulated as dry powder|CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.
16298437|NCT00657111|Other|Placebo|placebo capsules containing 25 mg lactose
16298438|NCT00657059|Drug|irbesartan|In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.
16298439|NCT00657059|Drug|methylprednisolone (MP) or prednisone (pred)|Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.
16298440|NCT00657059|Drug|mycophenolate mofetil (MMF)|Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.
16298441|NCT00657046|Drug|Droxidopa|Capsules containing 200 mg droxidopa
16298442|NCT00657046|Drug|Placebo|Capsules with mannitol substituted for droxidopa
16298443|NCT00657033|Drug|Levitra (Vardenafil, BAY38-9456)|BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
16298444|NCT00657033|Drug|Placebo|Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
16298445|NCT00657020|Drug|Nicotine|Nicotine lozenge containing 4 mg of nicotine
16298446|NCT00657020|Drug|Placebo|Placebo lozenge
16298447|NCT00657007|Biological|belimumab|"1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1).
~1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5)."
16298448|NCT00657007|Biological|belimumab|"4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2).
~4 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 6)."
16298449|NCT00657007|Biological|belimumab|"10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3).
~10 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 7)."
16298450|NCT00657007|Biological|belimumab|"20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4).
~20 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 8)."
16298451|NCT00657007|Biological|Placebo|"IV (in the vein) on Day 0 (Cohorts 1-4).
~IV (in the vein) on Days 0 and 21 (Cohorts 5-8)."
16298452|NCT00656994|Drug|Ramelteon|Ramelteon 16 mg, tablets, orally, once nightly for up to 6 months.
16298453|NCT00656994|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months
16298454|NCT00656981|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
16298455|NCT00656981|Drug|Placebo|The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
16298456|NCT00656968|Drug|10-day sequential treatment|esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10
16298457|NCT00656968|Drug|10-day concomitant therapy|esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10
16298458|NCT00656942|Device|Quantitative Sensory Testing (QST)|QST consists of a series of heat and cold stimulation tests.
16298459|NCT00656929|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
16298460|NCT00656929|Other|Placebo|Placebo tablets
16298461|NCT00656916|Drug|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
16298462|NCT00656890|Biological|sterile saline for injection|10mg/kg/dose sterile saline injected every other week for a total of 4 doses
16298463|NCT00656890|Biological|MDX-1100|10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
16298464|NCT00656864|Drug|Pioglitazone|Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.
16298465|NCT00656864|Drug|Placebo|placebo
16298466|NCT00656851|Drug|Pioglitazone|30mg/day for 16 weeks
16298467|NCT00656851|Behavioral|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
16298468|NCT00656838|Behavioral|Patients receives letter, phone call, office visit, educational materials|Behavioral
16298469|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 100 μg/mL
16298470|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 200 μg/mL
16298471|NCT00656825|Drug|P144 cream|P144 cream will be given at a dose of 300 μg/mL
16298472|NCT00656825|Drug|Placebo|Placebo will be randomly given to 4 subjects in each panel
16298473|NCT00656812|Drug|Rituximab|375 mg/m2 on day 1 of a 21-day treatment cycle
16298474|NCT00656812|Drug|2-CdA|0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
16298475|NCT00656799|Drug|sugammadex|At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.
16298476|NCT00656799|Drug|Rocuronium|After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered
16298477|NCT00656786|Drug|Menadione Topical Lotion|Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.
16298478|NCT00656786|Drug|Menadione Topical Lotion|Menadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy.
16298479|NCT00656773|Drug|Sufentanil|0.15 μg/kg, IV following by 0.075 μg/kg every 3 minutes during 15 minutes
16298480|NCT00656773|Drug|Morphine|0.15 mg/kg, IV following by 0.075 mg/kg every 3 minutes during 15 minutes
16298481|NCT00656760|Other|PET/CT|PET/CT is being performed on all patients in the study.
16298482|NCT00656747|Drug|Avelox (Moxifloxacin, BAY12-8039)|Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
16298483|NCT00656747|Drug|Amoxicillin clavulanic acid|Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
16298484|NCT00656734|Biological|MDX 1411|MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
16298485|NCT00656721|Device|Flutter Valve|"Flutter Valve (Scandipharm, Birmingham, AL) is shaped like a pipe with a hardened plastic mouthpiece at one end, a plastic protective, perforated cover at the other end, and a high-density stainless steel ball resting in a plastic circular cone on the inside. When the patient expires, a vibratory effect is transmitted to airways by the steel ball oscillation in order to facilitate mucociliary clearance.
~In our study, the use of the equipment was guided by a registered physical therapist, but the position (angle) was determined by the patient, according to his/her adaptation and perception of effectiveness of sputum clearance. The patients remained comfortably seated, breathing through the device for 15 minutes, starting from the total pulmonary capacity, and being free to cough. Thereafter, a 5-minute session of cough was done."
16298486|NCT00656708|Other|Kerlix AMD gauze|Use Kerlix AMD gauze as the wound dressing for the entire burn unit
16298487|NCT00656695|Drug|Iminoral|Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
16298803|NCT00654537|Drug|Atorvastatin|
16298804|NCT00654537|Drug|Pravastatin|
16298489|NCT00656682|Behavioral|Dietitian Counseling Alone|Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
16298490|NCT00656682|Behavioral|Dietitian Plus Community Group Lifestyle|Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes
16298491|NCT00656669|Drug|sunitinib alone|sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.
16298492|NCT00656669|Drug|sunitinib plus paclitaxel|sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
16298493|NCT00656669|Drug|doxorubicin and cyclophosphamide|doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.
16298494|NCT00656656|Drug|Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine|"Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks
~Rituximab: 1000 mg i.v. given twice at a 2-week interval
~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks
~Azathioprine: 2.5 mg/kg body weight daily p.o."
16298495|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 440 micrograms sirolimus each.
16298496|NCT00656643|Drug|Placebo|Two subconjunctival injections of placebo.
16298497|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 220 micrograms sirolimus each.
16298498|NCT00656643|Drug|Sirolimus|Two subconjunctival injections of 880 micrograms sirolimus each.
16298499|NCT00656630|Drug|Acamprosate|Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
16298500|NCT00656630|Drug|Naltrexone|50mg capsule, Once daily, 1 week duration
16298501|NCT00656630|Drug|Placebo|Matched placebo capsule, 1 week duration
16298502|NCT00656617|Drug|Idarubicin|12 mg/m^2 IV over 1 hour daily for 3 days (days 4 to 6)
16298503|NCT00656617|Drug|Cytarabine|1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7)
16298504|NCT00656617|Drug|Vorinostat|Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
16298505|NCT00656604|Genetic|proteomic profiling|at the time of each procedure.
16298506|NCT00656604|Procedure|lumpectomy or mastectomy|removal of breast tumor or removal of the entire breast in which the tumor is located
16298507|NCT00656604|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Prior to initiation of treatment
16298508|NCT00656604|Procedure|histopathologic examination|After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
16298509|NCT00656604|Procedure|magnetic resonance spectroscopy|Prior to initiation of treatment
16298510|NCT00656591|Drug|Methotrexate|Methotrexate
16298511|NCT00656578|Drug|4975|Single dose, solution
16298512|NCT00656578|Drug|Placebo|Single dose, solution
16298513|NCT00656552|Drug|Escitalopram|Patient undergo a double- blind therapy of Escitalopram (10 mg) orally daily during breakfast (n=50) or placebo (n=50) for four weeks.
16298514|NCT00656539|Drug|AzaSite®|Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
16298515|NCT00656526|Drug|Lidocaine, perineural injection, intraoperatively|0.5 cc lidocaine, one single injection over the dorsal root.
16298516|NCT00656526|Drug|Lidocaine|0.5 cc %2 lidocaine,single injection
16298517|NCT00656513|Drug|Pilocarpine|5mg by mouth 3 times a day for 12 weeks
16298518|NCT00656513|Procedure|ALTENS|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
16298519|NCT00656500|Behavioral|Standard brief advice|Brief general assistance with smoking cessation
16298520|NCT00656500|Behavioral|Quitline intervention|Brief intervention designed specifically to encourage quitline utilization
16298521|NCT00656487|Drug|rimonabant|double blind, placebo controlled, single 90 mg dose
16298522|NCT00656487|Drug|placebo|matched placebo
16298525|NCT00656461|Drug|MKC-1|30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
16298526|NCT00656448|Drug|Procrit|40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
16298527|NCT00656435|Drug|Bevacizumab|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
16298528|NCT00656422|Drug|insulin Levemir|The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
16298529|NCT00656422|Drug|insulin Lantus|The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
16298530|NCT00656409|Drug|Conjugated pneumococcal vaccine (Prevenar)|
16298531|NCT00656396|Device|Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)|Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time
16298532|NCT00656396|Procedure|Control Intervention|Standard care
16298533|NCT00656383|Other|Clients randomized to nurse-led clinic|Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
16298534|NCT00656383|Other|Clients receive leg ulcer care in their homes|Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
16298535|NCT00656370|Drug|recombinant human hyaluronidase|150 Units in 1mL
16298536|NCT00656357|Drug|SYN117 Placebo|Placebo
16298537|NCT00656357|Drug|SYN117 80 mg|SYN117 80 mg
16298538|NCT00656357|Drug|SYN117 160 mg|SYN117 160 mg
16298539|NCT00656357|Drug|Cocaine 10mg|IV Cocaine 10mg
16298540|NCT00656357|Drug|Cocaine 20mg|IV Cocaine 20mg
16298541|NCT00656357|Drug|Cocaine 40mg|IV Cocaine 40mg
16298542|NCT00656357|Drug|Saline|IV Cocaine Placebo
16298543|NCT00656344|Other|Cognitive behavioral treatment enhanced by virtual reality|A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.
16298544|NCT00656331|Drug|Amlodipine and Hydrocholorothiazide|Arm 1 gets Amlodipine and Arm 2 gets Hydrocholorothiazide
16298545|NCT00656318|Other|oral contraceptive pill (OCP; OCPs)|Daily administration of oral contraceptive pill for up to 3 months (2 months of daily administration required for the study).
16298546|NCT00656305|Device|ExAblate MRfFUS|MR guided focused ultrasound.
16298547|NCT00656305|Device|Sham|sham comparator
16298548|NCT00656292|Drug|Simvastatin|40 mg po/nasogastric tube (NG) every day for 6 days
16298549|NCT00656292|Drug|Placebo|1 pill po/NG every day x 6 days
16298550|NCT00656279|Behavioral|Intensive dietary phosphorus education|Intensive dietary phosphorus education will be completed using the Phosphorus Point System Tool, a booklet listing phosphorus points for food items based on the phosphorus content. Patients will be allotted a maximum of 32-40 phosphorus points daily. Points consumed will be tracked by the patients via daily tracking sheets which require patients to list the phosphorus food items consumed, the number of points, and the time and amount of phosphate binders. Patients in this group will also receive intensive education about phosphorus additives. As a part of the program that supports the tool, patients will receive weekly telephone calls for the first 6 weeks to address any questions about the tool and find phosphorus point values of foods not listed within the tool.
16298551|NCT00656266|Drug|mycophenolate mofetil|immunosuppresion medication called mycophenolate mofetil, also known as MMF or CellCept
16298552|NCT00656266|Other|placebo medication|medication that looks like mycophenolate mofetil
16298553|NCT00656253|Drug|Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.)|12 months period of Herbal Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
16298554|NCT00656253|Drug|Placebo|12 months period of placebo plus 1 month period without placebo
16298555|NCT00656240|Drug|DE-104 ophthalmic solution|
16298556|NCT00656240|Drug|DE-104 vehicle|
16298557|NCT00656227|Drug|Avotermin|Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo
16298558|NCT00656214|Drug|Lycopene|08 mg/day in two divided dosage
16298559|NCT00656214|Drug|Placebo|Two divided dosage
16298560|NCT00656201|Drug|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
16298561|NCT00656201|Drug|Intramuscular Progesterone|Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
16298562|NCT00656188|Drug|Levitra (Vardenafil, BAY38-9456)|Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse
16298563|NCT00656188|Drug|Placebo|Matching placebo
16298564|NCT00656175|Drug|raltegravir|raltegravir
16298565|NCT00656149|Procedure|Telerehabilitation of hand function|6 weeks, 1 hr/day FES-assisted exercise therapy on a workstation, supervised over the Internet.
16298566|NCT00656149|Procedure|Conventional exercise therapy|For one hour per day subjects perform range-of-motion tasks with a wristlet weight (20 min), precision tasks with a computer mouse (20 min) and receive cyclical electrical stimulation of hand muscles (20 min).
16298567|NCT00656136|Drug|placebo|Patients receive placebo once daily
16298568|NCT00656136|Drug|BIBW 2992|Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.
16298569|NCT00656123|Biological|Colon GVAX|Dose escalation: 1.4x10^8 to 7x10^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4
16298570|NCT00656123|Drug|cyclophosphamide|200 mg/m^2 administered IV on Day 1 of Cycles 1-4
16298571|NCT00656110|Drug|equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml|Bilateral 3rd/4th common digital nerve injections with neuroma treatment mixture given weekly for 3 weeks
16298572|NCT00656110|Drug|Normal saline - 1ml|Bilateral 3rd/4th common digital nerve injections with normal saline given weekly for 3 weeks
16298573|NCT00656097|Biological|CL184|CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
16298574|NCT00656097|Biological|HRIG|HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
16298575|NCT00656097|Biological|Placebo matching CL184|Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
16298576|NCT00656084|Drug|gemcitabine|900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
16298577|NCT00656084|Drug|mitoxantrone|"Novantrone 10 mg/m2on Day 1. The order of administration will be:
~Gemzar-->Novantrone-->Rituxan."
16298578|NCT00656084|Drug|rituximab|"Rituxan 375 mg/m2 on Day 1. The order of administration will be:
~Gemzar-->Novantrone-->Rituxan."
16298579|NCT00656058|Drug|Singulair (Montelukast Sodium)|Singulair (Montelukast Sodium):5-10 mg (weight based dosing) by mouth (PO) hour of sleep (HS)
16298580|NCT00656045|Behavioral|Dietary|All participants in the investigation will receive a standard 8-week behavioral obesity intervention with 8 weekly, 1 hour group counseling and education sessions. The intervention will include a reduced caloric prescription (1200-1500 kcal/day) and fat gram prescription (30% or less kcals from fat).
16298581|NCT00656045|Behavioral|Physical Activity|The Physical Activity arm will receive an activity goal (200 minutes/week of moderate-intense physical activity).
16298582|NCT00656045|Behavioral|TV Watching|The TV Watching arm will receive a TV watching goal of watching less than 10 hours of TV/week.
16298583|NCT00656032|Other|paricalcitol|1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
16298584|NCT00656032|Other|cinacalcet|0 to 180 mg administered orally every day for either 8 weeks or 16 weeks
16298585|NCT00656019|Drug|Vitamin D|0, 2000, 4000, and 6000 IU per day orally
16298586|NCT00656006|Drug|Albuferon|
16298587|NCT00656006|Drug|Ribavirin|
16298588|NCT00655993|Drug|simvastatin|40 mg po daily
16298589|NCT00655980|Drug|Vitamin B12 and folic acid|1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
16298590|NCT00655980|Drug|Nitrous oxide and placebo|
16298591|NCT00655980|Other|standard of care|
16298592|NCT00655967|Drug|Acamprosate (Campral)|"During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
~Treatment compliance will be monitored by counts of returned medication. Records of all concomitant medications will be taken at each study visit as well as reports of adverse events (as shown above)."
16298593|NCT00655967|Drug|Acamprosate|During the course of the study patients will be supplied with 333mg tablets of acamprosate provided by the Sponsor. The study medication will be administered at a dose of 666mg (=two tablets) three times a day for patients with a creatinine clearance >50. The dose will be 333mg three times a day for patients with a creatinine clearance in the range of 30-50.
16298594|NCT00655954|Procedure|Induced sputum|Used Ultrasonic nebuliser
16298595|NCT00655941|Behavioral|Dietary instruction|Weekly instruction by dieticians
16298596|NCT00655941|Other|Exercise|Supervised exercise in groups
16298597|NCT00655928|Drug|N-acetylcysteine|N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
16298598|NCT00655928|Drug|0.9% saline|0.9% saline 1 litre intravenous over 12 hours pre-operatively
16298599|NCT00655915|Other|Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine|Patients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration.
16298600|NCT00655902|Dietary Supplement|Trans fat (soy bean oil)|Industrially produced trans fatty acid from soy bean oil (15 g/d for 16 weeks). The fat (a total of 25 g/d) will be baked into buns.
16298601|NCT00655902|Dietary Supplement|Control fat (sunflower oil)|Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.
16298602|NCT00655889|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of biopsy from palate
~Papillary priming procedure
~Seven injection treatments to target sites
~Performance of study assessments (investigator and subject)"
16298603|NCT00655876|Drug|cetuximab|Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.
16298604|NCT00655876|Drug|cisplatin|Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.
16298605|NCT00655876|Drug|paclitaxel|Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.
16298606|NCT00655876|Radiation|radiation therapy|1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
16298607|NCT00655863|Drug|Alogliptin and Pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
16298608|NCT00655863|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
16298609|NCT00655863|Drug|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
16298610|NCT00655850|Drug|Paclitaxel|"Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:
~Dexamethasone 20mg, intravenously (IV)
~Diphenhydramine 50 mg IV
~Ranitidine 50 mg IV
~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.
~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)
~Paclitaxel Dose Levels:
~Dose Level 1 ________80 mg/m2/weekly
~Dose Level -1 ________70 mg/m2/weekly"
16298611|NCT00655850|Drug|Gemcitabine|"Premedication
~Prophylactic antiemetics: 5-HT3-receptor antagonist prior to infusion with gemcitabine.
~Prior to receiving paclitaxel chemotherapy
~Gemcitabine will be given at the initial dose of 200mg/m2/week (Dose Level 1) for 3 out of 4 weeks (Day 1, 8, 15), as a 30 minute (IV) infusion.
~The dose of gemcitabine can be escalated to 300mg/m2/weekly (Dose Level 2) after the first cycle of treatment if no significant toxicity is experienced.
~Gemcitabine Dose Levels:
~Dose Level 2 ________300 mg/m2/weekly
~Dose Level 1 ________200 mg/m2/weekly
~Dose Level -1 ________150 mg/m2/weekly"
16298612|NCT00655850|Biological|Avastin|"The dose of Avastin is 10 mg/kg IV every 2 weeks
~It will be administered following the administration of chemotherapy
~The first infusion will be administered over 90 minutes; if well tolerated, the second and subsequent doses will be administered as a 60-minute and 30-minute infusion, respectively.
~It should not be administered or mixed with dextrose solutions."
16298613|NCT00655837|Drug|SGN-40|4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
16298614|NCT00655837|Drug|rituximab|375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
16298615|NCT00655837|Drug|gemcitabine|1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
16298616|NCT00655824|Drug|ofatumumab|1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl
16298617|NCT00655811|Drug|Capsaicin|Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A
16298618|NCT00655811|Drug|Placebo moisturizing cream|Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
16298619|NCT00655798|Dietary Supplement|Placebo|plain yogurt and capsules containing cellulose
16298620|NCT00655798|Dietary Supplement|Plain Yogurt + mix of anti-oxidants capsules|plain yogurt and capsules containing mix of anti-oxidants
16298621|NCT00655798|Dietary Supplement|Yogurt containing Lactobacillus helveticus|Yogurt containing the probiotic Lactobacillus helveticus
16298622|NCT00655798|Dietary Supplement|Yogurt containing Bifidobacterium animalis ssp.|Yogurt containing the probiotic Bifidobacterium animalis ssp.
16298623|NCT00655785|Biological|VEGFR1-1084, VEGFR2-169|One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C
16298805|NCT00654537|Drug|Simvastatin|
16298624|NCT00655785|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17
16298625|NCT00655772|Other|Chlorine Dioxide|Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.
16298626|NCT00655746|Drug|Dasatinib + Omeprazole|Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
16298627|NCT00655733|Drug|HMPL-004|HMPL-004 1200 mg/d
16298628|NCT00655733|Drug|Placebo|Placebo 1200 mg/d
16298629|NCT00655720|Other|infant formula|"hydrolyzed infant formula without probiotics
~hydrolyzed infant formula with probiotics
~hydrolyzed infant formula with probiotics"
16298630|NCT00655707|Biological|Autologous Expanded CD34+ Haemopoietic cells|"Autologous expanded CD34+ cells obtained by leukapheresis on a single occasion by infusion into the hepatic artery or portal vein.
~Patient numbers 01 and 02 will receive 1x109 cells Patient numbers 03 and 04 will receive 1x1010 cells Patient numbers 05 and 06 will receive 2x1010 cells Patient numbers 07 and 08 will receive 5x1010 cells"
16298631|NCT00655694|Procedure|sputum, blood, urine, exhaled breath, lung function|
16298632|NCT00655681|Drug|pamidronate|The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.
16298633|NCT00655681|Other|saline|receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
16298634|NCT00655668|Drug|Lenalidomide|Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
16298635|NCT00655655|Drug|everolimus|Given orally
16298636|NCT00655655|Drug|vatalanib|Given orally
16298637|NCT00655655|Other|pharmacological study|Correlative study (Cohort IIA only)
16298638|NCT00655655|Other|laboratory biomarker analysis|Correlative study (Cohorts IIA and IIB)
16298639|NCT00655655|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative study (Cohort IIA only)
16298640|NCT00655655|Procedure|ultrasound imaging|Correlative study (Cohorts IIA and IIB)
16298641|NCT00655642|Drug|Ondansetron|4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
16298642|NCT00655642|Drug|Metoclopramide|10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
16298643|NCT00655642|Drug|Promethazine|12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
16298644|NCT00655642|Drug|Normal Saline|Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter
16298645|NCT00655629|Drug|Vardenafil ODT (STAXYN, BAY38-9456)|Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
16298646|NCT00655629|Drug|Placebo|Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
16298647|NCT00655616|Drug|Montelukast Placebo|"Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
~Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily"
16298648|NCT00655616|Drug|Salmeterol, Montelukast|"Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
~Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily"
16298649|NCT00655603|Other|Infusion of native hormones from the pancreas and gut (GLP-1)|Glucose-clamps at fasting levels during infusion of hormones in different combinations.
16298650|NCT00655590|Drug|Levitra (Vardenafil, BAY38-9456)|20 mg daily dosing
16298651|NCT00655590|Drug|Sildenafil|100 mg daily dosing
16298652|NCT00655590|Drug|Placebo|Matching placebos
16298653|NCT00655577|Behavioral|Exercise|Supervised, mainly home-based balance, strength and jumping exercises
16298654|NCT00655564|Drug|Alefacept|"Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
~Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose)."
16298655|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days
16298656|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days
16298657|NCT00655551|Drug|lacosamide|Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
16298658|NCT00655538|Drug|Placebo|po daily for 36 weeks
16298659|NCT00655538|Drug|dalcetrapib|600mg po daily for 36 weeks
16298660|NCT00655525|Dietary Supplement|fish oil|2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
16298661|NCT00655525|Dietary Supplement|placebo|placebo administered orally every day for 3 months
16298662|NCT00655512|Drug|pimecrolimus 1% cream|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
16298663|NCT00655512|Drug|hydrocortisonacetat 1% cream|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
16298664|NCT00655512|Drug|betamethasonvalerat 0,1% cream|twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
16298665|NCT00655512|Drug|clobetasol-17-propionat 0,05% cream|twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
16298666|NCT00655512|Drug|Placebo|twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
16298667|NCT00655499|Drug|Panitumumab|6 mg/kg
16298668|NCT00655499|Drug|Irinotecan hydrochloride|180 mg/kg
16298669|NCT00655499|Genetic|Chromogenic in situ hybridization|
16298670|NCT00655499|Genetic|Fluorescence in situ hybridization|
16298671|NCT00655499|Genetic|Gene expression analysis|
16298672|NCT00655499|Other|Laboratory biomarker analysis|
16298673|NCT00655486|Drug|lacosamide|Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
16298674|NCT00655473|Drug|Dalcetrapib (RO4607381)|600mg po daily for 24 months
16298675|NCT00655473|Drug|Placebo|po daily for 24 months
16298676|NCT00655460|Procedure|glucose control with computer generated recommendations|Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
16298677|NCT00655421|Other|Unaided Visual Inspection|Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
16298678|NCT00655421|Device|VelScope|Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
16298679|NCT00655421|Other|Toluidine Blue Assisted Oral Examination|Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
16298680|NCT00655408|Drug|elemental iron|Iron supplementation.
16298681|NCT00655395|Drug|Laromustine (VNP40101M) and Ara-C|"Laromustine 300 mg/m2 (cohort 1), 400 mg/m2 (cohort 2), 500 mg/m2 (cohort 3) IV on day 1 over 30 - 60 minutes. Laromustine will be administered approximately 3-4 hours following the start of infusional Ara C.
~Ara C at 100 mg/m2/day as a continuous infusion daily for 7 days. Appropriate antiemetics are given during the Ara C infusion."
16298682|NCT00655369|Drug|PD 0200390|oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
16298683|NCT00655369|Drug|PD 0200390|oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
16298684|NCT00655369|Drug|PD 0200390|oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
16298685|NCT00655369|Drug|PD 0200390|oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
16298686|NCT00655369|Drug|PD 0200390|oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
16298687|NCT00655369|Drug|Placebo|oral placebo daily dose, 3 capsules per dose during a six week treatment period.
16298688|NCT00655356|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face."
16298689|NCT00655356|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face."
16298690|NCT00655343|Drug|ATG-Fresenius S|"20 mg rabbit immunoglobulin (IgG) in 1 ml of sterile solution
~20 mg/kg body weight per day diluted in 500 ml physiological saline, slow intravenous infusion at days -3, -2, -1 prior to transplantation"
16298691|NCT00655330|Drug|Valsartan|Valsartan (160mg/day)
16298692|NCT00655330|Drug|Placebo|Placebo
16298693|NCT00655330|Drug|Probucol|Probucol (750mg/day)
16298694|NCT00655317|Other|Acupuncture|Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
16298695|NCT00655317|Other|Sham acupuncture|SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
16298696|NCT00655304|Device|Prometheus (R) liver support dialysis|6-8 hours of dialysis
16298697|NCT00655304|Device|CVVHDF (Continuously Veno-Venous Hemodiafiltration)|6-8 hours of dialysis with the CVVHDF system PrismaFlex offered by Gambro (Sweden).
16298698|NCT00655291|Drug|XP20B|
16298699|NCT00655291|Drug|Placebo|
16298700|NCT00655278|Drug|T2000|T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
16298701|NCT00655265|Drug|Colesevelam hydrochloride film-coated tablets|tablets
16298702|NCT00655265|Drug|Placebo|Tablets
16298703|NCT00655252|Drug|Everolimus|
16298704|NCT00655239|Behavioral|Neuroadaptive cognitive training|Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
16298705|NCT00655239|Behavioral|Computer games|The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
16298706|NCT00655226|Behavioral|Hepatitis C educational support groups|Hepatitis C educational support groups
16298707|NCT00655226|Behavioral|Cognitive Behavioral Therapy skills based group sessions|Eight CBT group sessions tailored for hepatitis C patients conducted by a clinical psychologist: 3 sessions conducted prior to IFN/ribavirin initiation, 1 session the day of IFN/ribavirin initiation, and 4 sessions during IFN/ribavirin treatment.
16298708|NCT00655213|Device|Symphony D 2450|
16298709|NCT00655213|Device|Symphony DR 2550|
16298710|NCT00655200|Drug|insulin detemir|Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
16298711|NCT00655187|Other|Collection of information|Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.
16298712|NCT00655187|Procedure|Collection of stool samples|Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.
16298713|NCT00655174|Drug|fluvoxamine|Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.
16298714|NCT00655174|Drug|sertraline|Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.
16298715|NCT00655174|Drug|Placebo|Patients in this study arm will receive capsules that appear identical to those of the two study drugs but will contain no active ingredient.
16298716|NCT00655161|Biological|GI-4000|subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence
16298717|NCT00655148|Biological|DTaP-IPV vero vaccine|DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
16298718|NCT00655148|Biological|DTaP-IPV mkc vaccine|DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
16298719|NCT00655135|Drug|LDP-02|Each patient in arms 2 & 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29.
16298720|NCT00655135|Drug|Placebo|Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
16298721|NCT00655122|Drug|Dalteparin sodium|Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
16298722|NCT00655122|Drug|Placebo|Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
16298723|NCT00655109|Drug|Olopatadine|Ophthalmic solution
16298724|NCT00655109|Drug|Fluticasone|Nasal spray
16298725|NCT00655109|Drug|Saline|Nasal spray
16298726|NCT00655109|Drug|Artificial tears|Ophthalmic Solution
16298727|NCT00655083|Drug|Nepadutant|0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
16298728|NCT00655083|Drug|Nepadutant|0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
16298729|NCT00655070|Device|Timi3 Transthoracic ultrasound|Low frequency ultrasound over the chest using Timi3 ultrasound device
16298730|NCT00655057|Drug|S-citalopram|Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.
16298731|NCT00655057|Behavioral|Cognitive behavioral therapy (CBT)|Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.
16298732|NCT00655057|Procedure|TRODAT-1 single photon emission computed tomographic (SPECT) imaging|Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
16298733|NCT00655044|Drug|insulin detemir|Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
16298734|NCT00655031|Dietary Supplement|Pomegranate Concentrate (POMx)|3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.
16298735|NCT00655031|Dietary Supplement|Placebo|3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.
16298736|NCT00655018|Dietary Supplement|Vitamin treatment (alpha tocopherol plus ascorbic acid)|alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
16298737|NCT00655018|Dietary Supplement|Placebo|placebo and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
16298738|NCT00655005|Other|questionnaire administration|Newly diagnosed HNC patients
16298739|NCT00655005|Procedure|quality-of-life assessment|following treatment
16298740|NCT00654992|Drug|Erythropoietin-Beta|300 IU/kg of EPO or saline intravenously before surgery
16298741|NCT00654992|Drug|Normal Saline|300 IU/kg of normal saline intravenously before surgery
16298742|NCT00654979|Device|SafeFlo IVC Filter|SafeFlo IVC Filter
16298743|NCT00654966|Drug|Urotensine II|A few drops of the drug will be administered to the skin by iontophoresis.
16298744|NCT00654966|Drug|Soluble epoxide hydrolase|A few drops of the drug will be administered to the skin by iontophoresis.
16298745|NCT00654953|Drug|sertraline|Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be administered capsules once weekly, with take-home doses given in blister packs to take once a day for the rest of the week.
16298746|NCT00654953|Drug|Placebo|Placebo (cellulose or lactose) administered twice per day for 12 weeks.
16298747|NCT00654953|Drug|gabapentin|Gabapentin (Neurontin; Parke-Davis; 1200 mg/day) will be administered twice daily. Initially, patients will receive 200 mg twice daily on days 1-5, 400 mg twice daily on days 6-10, then 600 mg twice daily on days 11 on. Subjects are then maintained on this dose for the duration of the trial, unless side-effects are too severe, in which case the dose of gabapentin is decreased to no less 800 mg/day. If symptoms persist, subjects' participation would then be terminated.
16298748|NCT00654940|Drug|Pregabalin (Lyrica)|Oral, 75mg or 150mg capsules, BID
16298749|NCT00654940|Drug|Placebo|Oral, matched capsules, BID
16298750|NCT00654927|Drug|Fampridine-SR b.i.d. (Twice Daily)|Dosage form - tablets.
16298751|NCT00654914|Drug|Levitra (Vardenafil, BAY38-9456)|10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .
16298752|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)|0.5 mL, Intramuscular
16298753|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)|0.5 mL, Intramuscular
16298754|NCT00654901|Biological|DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)|0.5 mL, Intramuscular
16298755|NCT00654901|Biological|Infanrix Hexa™|0.5 mL, Intramuscular
16298756|NCT00654888|Procedure|ALK (automated lamellar keratectomy)|ALK is performed with a microkeratome, to make a free cap.
16298757|NCT00654888|Drug|Mitomycin|mitomycin 0,02%, 30 seconds after ALK
16298758|NCT00654875|Drug|Aliskiren|Aliskiren supplied in 150 mg and 300 mg tablets.
16298759|NCT00654875|Drug|Placebo to Aliskiren|Placebo to Aliskiren matching 150 and 300 mg tablets
16298760|NCT00654862|Dietary Supplement|cocoa polyphenols|Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
16298761|NCT00654862|Dietary Supplement|cocoa polyphenols|Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo
16298762|NCT00654849|Procedure|Plasmakinetic bipolar energy forceps|Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
16298763|NCT00654849|Procedure|Abdominal Hysterectomy with traditional suture technique|The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.
16298764|NCT00654836|Biological|bevacizumab|Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43.
16298765|NCT00654836|Drug|Carboplatin|Participants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43.
16298766|NCT00654836|Drug|ABI-007|Participants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.
16298767|NCT00654810|Behavioral|Walking Exercise|Intermittent treadmill walking to near maximal claudication pain three days per week
16298768|NCT00654797|Procedure|glucose control with computer generated recommendations|Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
16298769|NCT00654784|Drug|idebenone|idebenone 450 mg/day (150 mg three times a day)
16298770|NCT00654784|Drug|placebo|
16298771|NCT00654771|Other|urine collection|clean catch urine collection and catheterized urine collection
16298772|NCT00654758|Drug|M200 (Volociximab), Carboplatin, Paclitaxel|Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
16298773|NCT00654745|Drug|Amlodipine|Amlodipine 5 mg tablets , Daily for 3 weeks;
16298774|NCT00654745|Drug|amlodipine / olmesartan medoxomil combination|amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
16298775|NCT00654745|Drug|Hydrochlorothiazide|hydrochlorothiazide tablets, 12.5 mg or 25 mg.
16298776|NCT00654732|Drug|Bleomycin|Given IV
16298777|NCT00654732|Drug|Dacarbazine|Given IV
16298778|NCT00654732|Drug|Doxorubicin Hydrochloride|Given IV
16298779|NCT00654732|Biological|Rituximab|Given IV
16298780|NCT00654732|Drug|Vinblastine|Given IV
16298781|NCT00654719|Dietary Supplement|NutriDrink|Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
16298782|NCT00654719|Dietary Supplement|Placebo|Nutritional supplementation containing only 12 kcal/day
16298783|NCT00654706|Drug|Sertindole|Once daily oral dose. Day 1-20: 4-16 mg/day (titration period). Day 21-84: 12, 16 or 20 mg/day (flexible treatment period).
16298784|NCT00654706|Drug|Quetiapine|Twice daily oral dose. Day 1-20: 50-500 mg/day (titration period). Day 21-84: 400, 500 or 600 mg/day (flexible treatment period).
16298785|NCT00654693|Other|Rapid Response Team|If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.
16298786|NCT00654680|Drug|Vardenafil (Levitra, BAY38-9456)|5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
16298787|NCT00654680|Drug|Placebo|Matching placebo
16298788|NCT00654667|Drug|Placebo|Placebo, no active drug, take 5 capsules by mouth daily for one month
16298789|NCT00654667|Drug|Resveratrol|
16298790|NCT00654654|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm biopsies
~Two injection treatments of facial wrinkles and creases
~Conduct of study assessments"
16298791|NCT00654641|Procedure|Negative pressure wound closure|Applying negative pressure to primary wound closure
16298792|NCT00654641|Procedure|Standard wound closure|Standard wound closure
16298793|NCT00654628|Drug|ezetimibe (+) simvastatin|Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
16298794|NCT00654615|Device|Intramedullary Radius Fixation (Micronail)|After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing.
16298795|NCT00654615|Procedure|Volar Plate Fixation|After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied.
16298796|NCT00654602|Drug|Rosuvastatin|
16298797|NCT00654602|Behavioral|Maintenance of specific diet|
16298798|NCT00654589|Drug|Deferasirox|
16298799|NCT00654576|Drug|Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole|patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.
16298800|NCT00654576|Behavioral|psychosocial intervention|the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
16298801|NCT00654550|Drug|Nexagon™ or Nexagon™ vehicle|Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
16298802|NCT00654537|Drug|Rosuvastatin|
16298806|NCT00654524|Drug|gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin|The patient will be managed with GnRH-a injection (Goserelin 3.6mg) every 4 weeks for 6 months plus add-back therapy (Caltrate With Vitamin D 600mg p.o. q.d.& Livial 1.25-2.5mg p.o. q.d.) if needed.
16298807|NCT00654511|Drug|Fentanyl|Fentanyl 1mcg/kg, Intravenous (IV)
16298808|NCT00654511|Drug|Fentanyl|Fentanyl 2mcg/kg, Intravenous (IV)
16298809|NCT00654511|Drug|Dexmedetomidine|Dexmedetomidine, 2mcg/kg, Intravenous (IV)
16298810|NCT00654511|Drug|Dexmedetomidine|Dexmedetomidine, 4mcg/kg Intravenous (IV)
16298811|NCT00654498|Drug|Pramipexole|
16298812|NCT00654498|Drug|Placebo|
16298813|NCT00654485|Drug|Rosuvastatin|
16298814|NCT00654485|Drug|Atorvastatin|
16298815|NCT00654459|Dietary Supplement|Mixture of Berberine, Policosanol, Red Yeast, Placebo|A tablet one a day for 6 weeks
16298816|NCT00654446|Drug|Rosuvastatin|
16298817|NCT00654446|Drug|Simvastatin|
16298818|NCT00654433|Biological|ALD-101|A subpopulation of cord blood cells composed of cells that express a high level of the intracellular enzyme aldehyde dehydrogenase (ALDH).
16298819|NCT00654420|Drug|Dalotuzumab|Dalotuzumab 20 mg/mL in sterile solution. Intravenous (IV) infusion over 60 minutes at 5 mg/kg, administered weekly at dosage according to treatment group.
16298820|NCT00654420|Drug|Erlotinib|Open-label erlotinib administrated orally (tablets) by mouth (PO) at 150 mg daily.
16298821|NCT00654407|Drug|Rosuvastatin|
16298822|NCT00654407|Drug|Atorvastatin|
16298823|NCT00654407|Drug|Simvastatin|
16298824|NCT00654394|Drug|Rosuvastatin|
16298825|NCT00654381|Drug|BI 1356|5 mg/daily
16298826|NCT00654381|Drug|BI 1356|10 mg/daily
16298827|NCT00654381|Drug|voglibose placebo|three times daily
16298828|NCT00654381|Drug|BI 1356 placebo|once daily
16298829|NCT00654381|Drug|voglibose|0.6 mg/daily
16298830|NCT00654368|Biological|Etanercept|Commercially available etanercept administered subcutaneously at 50 mg/week.
16298831|NCT00654368|Drug|Methotrexate|Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
16298832|NCT00654355|Drug|tacrolimus ointment|tacrolimus ointment to be applied twice daily to affected areas during duration of study
16298833|NCT00654342|Procedure|Intraoperative injection (in vivo)|Intraoperative injection
16298834|NCT00654342|Procedure|Postoperative injection (ex vivo)|postoperative injection
16298835|NCT00654329|Drug|Saline|Normal saline, given intranasally
16298836|NCT00654329|Drug|Fentanyl|Fentanyl, nasal transmucosal, 2 micrograms/kilogram
16298837|NCT00654329|Drug|Dexmedetomidine|Dexmedetomidine, transmucosal, 1 microgram/kilogram
16298838|NCT00654329|Drug|Dexmedetomidine|Dexmedetomidine, 2 microgram/kilogram, transmucosal route
16298839|NCT00654316|Biological|BCG|intradermal injection of 0.1ml BCG over the deltoid muscle
16298840|NCT00654303|Drug|Rosuvastatin|
16298841|NCT00654290|Drug|Amiodarone + Propranolol|Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
16298842|NCT00654290|Drug|Amiodarone|Amiodarone treated 7 days pre-operation to 5 days post CABG
16298843|NCT00654290|Drug|Propranolol|Propranolol from 7 days pre-operation to 5 days post CABG
16298844|NCT00654277|Drug|Ondansetron|ODT, 8 mg, single-dose
16298845|NCT00654277|Drug|Zofran|ODT, 8 mg, fasting conditions
16298846|NCT00654264|Procedure|Water immersion|Subjects will sit in tub for four hours.
16298847|NCT00654238|Drug|sorafenib|400mg PO BID daily
16298848|NCT00654225|Drug|Rosuvastatin|
16298849|NCT00654225|Drug|Atorvastatin|
16298850|NCT00654212|Procedure|endo-laparoscopic approach|endoluminal stenting followed by laparoscopic resection
16298851|NCT00654212|Procedure|open approach|emergency open surgery
16298852|NCT00654186|Drug|Revlimid|25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
16298853|NCT00654173|Drug|Rosuvastatin|
16298854|NCT00654173|Drug|Simvastatin|
16298855|NCT00654173|Drug|Atorvastatin|
16298856|NCT00654160|Drug|fluorouracil|
16298857|NCT00654160|Drug|irinotecan hydrochloride|
16298858|NCT00654160|Drug|leucovorin calcium|
16298859|NCT00654160|Other|pharmacogenomic studies|
16298860|NCT00654160|Other|pharmacological study|
16298861|NCT00654147|Drug|Raltegravir & Lopinavir/ritonavir|Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor
16298862|NCT00654147|Drug|Raltegravir and emtricitabine/tenofovir|Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors
16298863|NCT00654134|Biological|Clinical Center Reference Endotoxin|20,000 EU inhaled
16298864|NCT00654121|Drug|Actrapid HM|56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
16298865|NCT00654108|Drug|Ciprofloxacin|500 milligrams(mg) will be administered orally twice daily for 5 days.
16298866|NCT00654108|Biological|Peru-15-pCTB|Live attenuated oral combined ETEC-cholera (Peru-15 pCTB) vaccine co-administered with bicarbonate buffer solution; vaccine dose levels 1 X 10^7; 1 X 10^8; 1 X 10^9; and 1 X 10^10.
16298867|NCT00654108|Other|Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer|Buffer solution: 2.5 grams (g) Sodium Bicarbonate powder, 1.65 g Ascorbic Acid and 25 mg Aspartame, in 100 milliliters (mL) water for injection.
16298868|NCT00654095|Drug|Ezetimibe|Ezetimibe 10 mg once daily
16298869|NCT00654095|Drug|atorvastatin|atorvastatin 20 mg once daily
16298870|NCT00654082|Drug|sildenafil|sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg
16298871|NCT00654082|Drug|placebo|placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
16298872|NCT00654069|Drug|Placebo|2 tablets every 6 hours for 48 hours
16298873|NCT00654069|Drug|Acurox 5/30 mg|2 tablets every 6 hours for 48 hours
16298874|NCT00654069|Drug|Acurox 7.5/30|2 tablets every 6 hours for 48 hours
16299935|NCT00646971|Device|Placebo device|for 4 weeks
16298875|NCT00654056|Drug|Actrapid (human insulin)|On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours
16298876|NCT00654043|Drug|Torsemide|tablets, 20 Mg, single-dose
16298877|NCT00654043|Drug|Demadex|Tablets, 20 mg, single-dose
16298878|NCT00654030|Drug|1650-G Vaccine|.6ml injection administered intradermally in the thigh at week 0 and week 4
16298879|NCT00654017|Drug|placebo|Placebo comparator to be given per protocol.
16298880|NCT00654017|Drug|sildenafil|oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability
16298881|NCT00653991|Behavioral|SOLVE-IT|SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
16298882|NCT00653978|Procedure|ERCP plus one biliary stent|ERCP ＋ one biliary stent insertion
16298883|NCT00653978|Procedure|ERCP plus two biliary stents|ERCP ＋ two biliary stents insertion
16298884|NCT00653965|Drug|Rosuvastatin|
16298885|NCT00653965|Drug|Atorvastatin|
16298886|NCT00653952|Drug|CAELYX|Dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year
16298887|NCT00653952|Drug|Paclitaxel HCl|Dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cy
16298888|NCT00653939|Drug|Fosbretabulin|Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
16298889|NCT00653939|Drug|Carboplatin|Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
16298890|NCT00653939|Drug|Paclitaxel|Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
16298891|NCT00653939|Drug|Bevacizumab|Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
16298892|NCT00653926|Drug|ropivacaine, ketorelac and epinephrine|In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
16298893|NCT00653926|Drug|saline|In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
16298894|NCT00653913|Drug|SCH 58235|SCH 58235 10 mg (once daily)
16298895|NCT00653913|Drug|pitavastatin|Pitavastatin 2 mg (once daily)
16298896|NCT00653887|Other|Biofeedback|4 sessions of biofeedback one session each week
16298897|NCT00653887|Other|Placebo|4 sessions, one each week, of discussion about anorectal disease
16298898|NCT00653874|Device|BiliChek (jaundice assessment)|assessment of jaundice was done by either transcutaneous bilirubinometry (TcB) method or by clinical assessment of bilirubin (CaB)
16298899|NCT00653874|Procedure|Transcutaneous bilirubinometry (TcB)|transcutaneous bilirubinometry was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life
16298900|NCT00653874|Other|Clinical asessment of bilirubin (CaB)|Clinical assessment of bilirubin (CaB) was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life
16298901|NCT00653861|Device|JUVÉDERM™ Injectable Gel with Lidocaine|Single treatment, volume determined by investigator
16298902|NCT00653861|Device|JUVÉDERM™ Injectable Gel|Single treatment, volume determined by investigator
16298903|NCT00653848|Drug|docetaxel|docetaxel 75 mg/square meter i.v. every third week, six cycles
16298904|NCT00653835|Drug|Ezetimibe + Simvastatin|oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
16298905|NCT00653835|Drug|Simvastatin|oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
16298906|NCT00653822|Drug|alefacept|IC and SC
16298907|NCT00653822|Drug|placebo|IV and SC
16298908|NCT00653796|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
16298909|NCT00653796|Drug|Atorvastatin|oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
16298910|NCT00653770|Biological|FP85A|Recombinant Fowlpox virus 9 expressing antigen 85A from M. tuberculosis (5 x10^7 pfu)
16298911|NCT00653770|Biological|MVA85A|Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis (5 x 10^7 pfu)
16298912|NCT00653757|Drug|goserelin acetate|
16298913|NCT00653757|Drug|leuprolide acetate|
16298914|NCT00653757|Radiation|image-guided radiation therapy|
16298915|NCT00653757|Radiation|intensity-modulated radiation therapy|
16298916|NCT00653744|Drug|Rosuvastatin|
16298917|NCT00653744|Drug|Atorvastatin|
16298918|NCT00653731|Behavioral|Snoezelen ©|Nursing individual intervention one time a week for 20 minutes
16298919|NCT00653731|Behavioral|structured reminiscence therapy|Individual nursing intervention: one time a week 20 minutes
16298920|NCT00653731|Behavioral|10-minutes activation|Individual nursing intervention: two times a week for 10 minutes
16298921|NCT00653731|Behavioral|Unstructured verbal communication|Individual nursing intervention: one time a week for 20 minutes
16298922|NCT00653705|Other|Yogurt drink with probiotic bacteria BB12|Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.
16298923|NCT00653705|Other|Placebo|Vanilla flavored dairy drink. One bottle a day for 16 weeks.
16298924|NCT00653679|Other|exercise|1 hour of endurance or resistance exercise
16298925|NCT00653666|Other|Medically supervised fasting|Metabolic fasting studies will be conducted over an 18-hour period or until blood glucose is < 40 mg/dl. If the YSI reading is 40 mg/dl or less, at any time during the study, then a blood sample will be collected, and the fast terminated by giving D25W IV and then feeding orally.
16298926|NCT00653640|Procedure|body weight supported treadmill training|BWSTT for 12 weeks, 3 times per week
16298927|NCT00653640|Procedure|traditional physical therapy|traditional PT for 12 weeks, 3 times per week
16298928|NCT00653627|Biological|BCG|Mycobacterium bovis Bacille Calmette-Guerin
16298929|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)|Single dose administration of E2 + DRSP as a tablet
16298930|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 2 (80458739)|Single dose administration of E2 + DRSP as a tablet
16298931|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 3 (80458755)|Single dose administration of E2 + DRSP as a tablet
16298932|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 4 (80458720)|Single dose administration of E2 + DRSP as a tablet
16298933|NCT00653614|Drug|E2/DRSP (BAY 86-4891) dose 5 (80458712)|Single dose administration of E2 + DRSP as a tablet
16298934|NCT00653614|Drug|DRSP (ZK 30595) dose 1 (SH T04984F)|Single dose administration of DRSP as a tablet
16298935|NCT00653614|Drug|DRSP (ZK 30595) dose 2 (80458690)|Single dose administration of DRSP as a tablet
16298936|NCT00653614|Drug|Placebo|Placebo administration in each arm
16298937|NCT00653588|Drug|Rosuvastatin|40mg
16298938|NCT00653588|Drug|Atorvastatin|80mg
16298939|NCT00653575|Behavioral|Information-Motivation-Behavioral Skills model|The Information-Motivation-Behavioral Skills model is an influential and empirically supported theory of health behavior. The model suggests that HIV-related information, motivation, and behavioral skills are important determinants of sexual behavior; thus, childhood sexual abuse may lead to deficits in these areas. This model will be used to guide research interviews.
16298940|NCT00653575|Behavioral|Traumagenic Dynamics model|The Traumagenic Dynamics model is an influential and empirically supported model of the effects of childhood sexual abuse. The model suggests that childhood sexual abuse leads to traumatic sexualization, stigmatization, betrayal, and powerlessness and that these four traumagenic dynamics lead to adverse outcomes, including increased rates of sexual risk behavior. This model will be used to guide research interviews.
16298941|NCT00653562|Drug|zolpidem|Oral
16298942|NCT00653549|Drug|Torsemide|Tablets, 20 mg, single-dose
16298943|NCT00653549|Drug|Demadex|tablets, 20 mg, single-dose
16298944|NCT00653536|Device|NeuroFlo|The device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization.
16298945|NCT00653523|Drug|Ezetimibe|Ezetimibe 10 mg once daily
16298946|NCT00653523|Drug|Simvastatin|Simvastatin 20 mg daily
16298947|NCT00653510|Drug|Actrapid (human insulin)|On day one the patients will receive glucose and insulin in order to reach a blood sugar around 18 and 20 mmol/L and on day two the patients will receive glucose and insulin in order to have a blood sugar around 5 and 7 mmol/L. On both days amino acid, lipid and glucose metabolism will be assessed by means of whole body isotope dilution.
16298948|NCT00653497|Behavioral|Aquatic exercise|"Arthritis Foundation Aquatics Program
~community-based aquatic exercise program
~participants asked to attend 2 classes per week for 20 weeks
~each class 45-60 minutes in duration"
16298949|NCT00653484|Behavioral|Physical Activity|
16298950|NCT00653484|Behavioral|Energy Restriction|
16298951|NCT00653484|Behavioral|Physical Activity and Energy Restriction|
16298952|NCT00653471|Device|Microcapmicro-stream device with Smart CapnoLine Plus|nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
16298953|NCT00653471|Device|Microcap micro-stream device with CapnoLine|CO2 measured via nasal cannula
16298954|NCT00653471|Device|TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).|CO2 measured via nasal cannula
16298955|NCT00653458|Drug|Ondansetron|ODT, 8 mg, single-dose, fed conditions
16298956|NCT00653458|Drug|Zofran|ODT, 8 mg, single-dose, under fed conditions
16298957|NCT00653445|Drug|Rosuvastatin|40mg
16298958|NCT00653445|Drug|Ezetimibe|10mg
16298959|NCT00653432|Device|Monovisc®|Intra-articular injection
16298960|NCT00653432|Other|Saline|0.9% Sterile Saline
16298961|NCT00653419|Drug|buspirone HCl|Tablets, 30 mg, single-dose
16298962|NCT00653419|Drug|Buspar|Tablets, 30 mg, single-dose
16298963|NCT00653406|Drug|Risperidone long acting injectable|
16298964|NCT00653393|Drug|Tranylcypromine|Tablets, 10 mg, single-dose
16298965|NCT00653393|Drug|Parnate|Tablets, 10 mg, single-dose
16298966|NCT00653380|Drug|Doxycycline Monohydrate|Capsules, 100 mg, single-dose
16298967|NCT00653380|Drug|Monodox|Capsules, 100 mg, single-dose
16298968|NCT00653367|Procedure|Nerve section|Intercostal nerve is divided during surgery
16298969|NCT00653354|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
16298970|NCT00653354|Drug|valdecoxib/placebo|valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
16298971|NCT00653354|Drug|placebo|placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
16298972|NCT00653341|Drug|insulin glargine|
16298973|NCT00653341|Drug|NPH human insulin|
16298974|NCT00653328|Drug|atrasentan hydrochloride|Atrasentan 10 mg orally everyday continuously beginning on Day 1.
16298975|NCT00653328|Drug|doxil|50 mg/m2 intravenously every 28 days
16298976|NCT00653315|Drug|Tramadol APAP|Tablets, 37.5mg/325mg, single dose
16298977|NCT00653315|Drug|Ultracet|Tablets, 37.5mg/325mg
16298978|NCT00653302|Drug|Lantus (insulin glargine) + Glucophage (Metformin)|
16298979|NCT00653276|Drug|ezetimibe|ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
16298980|NCT00653276|Drug|Comparator: cyclosporine|single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
16298981|NCT00653250|Drug|celecoxib|400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)
16298982|NCT00653250|Procedure|biopsy|in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue
16298983|NCT00653250|Procedure|therapeutic conventional surgery|surgery to remove the lung tumor
16298984|NCT00653237|Device|I-gel and LMA Supreme: supraglottic airway devices|Insertion of a supraglottic airway device
16298985|NCT00653224|Drug|levocetirizine dihydrochloride|5 mg daily (oral tablet) for 14 days
16298986|NCT00653224|Drug|placebo|0 mg daily (matching oral tablet) for 14 days
16298987|NCT00653198|Other|No intervention|
16298988|NCT00653185|Drug|SYR-472|SYR-472 25 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
16298989|NCT00653185|Drug|SYR-472|SYR-472 50 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
16298990|NCT00653185|Drug|SYR-472|SYR-472 100 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
16298991|NCT00653185|Drug|SYR-472|SYR-472 200 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
16298992|NCT00653185|Drug|Placebo|SYR-472 placebo-matching tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
16298993|NCT00653172|Drug|NXL103|600mg orally twice daily
16298994|NCT00653172|Drug|comparator|comparator twice daily
16298995|NCT00653172|Drug|NXL103|500mg orally twice daily
16298996|NCT00653159|Device|Levonorgestrel-releasing intrauterine device (LNG-IUS)|Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
16298997|NCT00653159|Device|Copper T380A intrauterine device (CuT380A)|Teens are randomly assigned to Copper T380 after the screening visit
16298998|NCT00653146|Behavioral|Mindfulness-Based Stress Reduction|In the intervention program, a variety of mindfulness meditation techniques will be taught, including the body scan, awareness of breathing, mindful yoga, eating meditation and walking meditation.
16298999|NCT00653146|Behavioral|Healthy Lifestyles|In the control condition, information on healthy lifestyles will be presented in a didactic fashion. Session topics include diet and nutrition, physical activity, and healthy behaviors to prevent cardiovascular disease and cancer.
16299000|NCT00653133|Device|Ultrasound imaging|Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
16299001|NCT00653133|Device|Peripheral nerve stimulator|either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic
16299002|NCT00653120|Drug|Propranolol|ER capsules, 160 mg, single-dose
16299003|NCT00653120|Drug|Inderal-LA|ER capsules, 160 mg, single-dose
16299004|NCT00653107|Procedure|Stent insertion|Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.
16299005|NCT00653107|Radiation|Brachytherapy|a flexible applicator (with a diameter adapted to the stent's diameter) will be introduced into the oesophagus, so the applicator will be lying in the middle of the lumen of the stent. Thereafter, the flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (> 12 Gy/h).
16299006|NCT00653107|Radiation|Brachytherapy|a flexible applicator will be introduced into the oesophagus. The flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (> 12 Gy/h).
16299007|NCT00653094|Device|Halevy kit|the use of Halevy kit in Crohn patients with Fistulas
16299008|NCT00653081|Procedure|Physical therapy method called Supervised Exercises|Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
16299009|NCT00653081|Procedure|Radial Extracorporeal Shockwave Therapy|Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
16299010|NCT00653068|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16299011|NCT00653068|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC rescue
16299012|NCT00653068|Drug|Carboplatin|Given IV
16299013|NCT00653068|Drug|Cisplatin|Given IV
16299014|NCT00653068|Drug|Cyclophosphamide|Given IV
16299015|NCT00653068|Drug|Etoposide|Given IV
16299016|NCT00653068|Biological|Filgrastim|Given IV or SC
16299017|NCT00653068|Other|Laboratory Biomarker Analysis|Correlative studies
16299018|NCT00653068|Drug|Leucovorin Calcium|Given IV or PO
16299019|NCT00653068|Drug|Methotrexate|Given IV
16299020|NCT00653068|Drug|Thiotepa|Given IV
16299021|NCT00653068|Drug|Vincristine Sulfate|Given IV
16299022|NCT00653055|Drug|Cabergoline|Tablets, 0.5 mg (2 x 0.5 mg dose),fasting
16299023|NCT00653055|Drug|Dostinex|Tablets, 0.5 mg (2 x 0.5 mg dose), fasting
16299024|NCT00653042|Drug|Nesiritide|
16299025|NCT00653016|Drug|norelgestromin; ethinyl estradiol|
16299026|NCT00653003|Drug|Leflunomide|tablets, 20mg, single-dose
16299027|NCT00653003|Drug|ARAVA|Tablets, 20mg, single-dose
16299028|NCT00652977|Procedure|Ritgens maneuver|Delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The maneuver was used during a uterine contraction
16299029|NCT00652977|Procedure|Standard care (Manual support of the perineum)|The protocol entailed our standard care: using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
16299030|NCT00652964|Device|CPAP|CPAP treatment for patients with congenital central hypoventilation syndrome
16299031|NCT00652951|Biological|GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)|Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
16299032|NCT00652951|Biological|Infanrix™ hexa.|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
16299033|NCT00652951|Biological|Pediacel™|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
16299034|NCT00652951|Biological|Prevenar™|Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
16299035|NCT00652938|Biological|HPV Vaccine (GSK580299) Cervarix TM|IM administration
16299036|NCT00652938|Biological|Engerix B|IM administration
16299037|NCT00652925|Drug|Celecoxib|Higher dose, 6 mg/kg/dose BID
16299038|NCT00652925|Drug|Celecoxib|Active drug at lower dose
16299039|NCT00652925|Drug|Naproxen|Control comparator, 15 mg/kg/dy target dose
16299040|NCT00652912|Drug|Clonazepam|ODT, 1 mg
16299041|NCT00652912|Drug|Klonopin Wafers|ODT, 1 mg
16299042|NCT00652899|Biological|Allopurinol|All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
16299043|NCT00652899|Drug|Cyclophosphamide|60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion.
16299044|NCT00652899|Drug|Fludarabine phosphate|25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion.
16299045|NCT00652899|Radiation|total-body irradiation|200 cGy Day 1 preceding natural killer cell infusion.
16299046|NCT00652899|Biological|Allogeneic natural killer cells|Given day 0 - dose of 1.5-8.0 * 10^7/kg
16299047|NCT00652899|Biological|Aldesleukin|10 MU 3 times/week for a total of 6 doses beginning Day 0
16299048|NCT00652886|Drug|Oxandrolone|Tablets, 10mg, single-dose
16299049|NCT00652886|Drug|Oxandrin|tablets, 10mg, single-dose
16299050|NCT00652873|Drug|Cabergoline|Tablets 0.5 mg (2 x 0.5 mg dose), fed
16299051|NCT00652873|Drug|Dostinex|Tablets, 0.5 mg (2 X 0.5 mg dose), fed
16299052|NCT00652860|Biological|aerosol sargramostim|
16299053|NCT00652860|Biological|sargramostim|
16299054|NCT00652860|Drug|cisplatin|
16299055|NCT00652860|Drug|doxorubicin hydrochloride|
16299056|NCT00652860|Drug|ifosfamide|
16299057|NCT00652860|Drug|mitomycin C|
16299058|NCT00652860|Other|flow cytometry|
16299059|NCT00652860|Other|immunological diagnostic method|
16299060|NCT00652860|Other|laboratory biomarker analysis|
16299061|NCT00652860|Procedure|adjuvant therapy|
16299062|NCT00652860|Procedure|multimodality therapy|
16299063|NCT00652860|Procedure|neoadjuvant therapy|
16299064|NCT00652860|Procedure|therapeutic conventional surgery|
16299065|NCT00652860|Radiation|intraoperative radiation therapy|
16299066|NCT00652860|Radiation|selective external radiation therapy|
16299067|NCT00652847|Drug|ezetimibe|ezetimibe 10 mg/day for a six week course of treatment.
16299068|NCT00652847|Drug|statins|patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
16299069|NCT00652834|Procedure|Small bowel capsule endoscopy (SBCE)|SBCE will be performed at Day 2 and Day 30.
16299070|NCT00652834|Drug|myfortic|switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
16299071|NCT00652821|Drug|Tramadol/ APAP|Tablets 37.5mg /325mg
16299072|NCT00652821|Drug|Ultracet|Tablets, 37.5mg/325mg
16299073|NCT00652808|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily for 6 weeks
16299074|NCT00652808|Drug|naproxen|naproxen 500 mg capsule by mouth twice daily for 6 weeks
16299075|NCT00652795|Drug|Doxycycline Monohydrate|Tablets, 150 mg, single-dose
16299076|NCT00652795|Drug|Monodox|Capsules 50 mg (3 x 50 mg dose), single-dose
16299077|NCT00652782|Drug|rolofyline|rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
16299078|NCT00652782|Drug|Comparator Placebo (unspecified)|Matching placebo for rolofyline IV QD; 3 days
16299079|NCT00652769|Procedure|Endobronchial or Endoscopic Ultrasound|Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.
16299080|NCT00652769|Procedure|Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy|Investigations will be determined by the multi-disciplinary team responsible for the patient
16299081|NCT00652756|Device|Use of ventilator during patient transport (Versamed iVent)|The goal of the transport ventilator is to provide optimal ventilation.
16299082|NCT00652756|Other|Bag-valve ventilation|Use of bag-valve ventilation during patient transport.
16299083|NCT00652743|Biological|Pandemic influenza vaccine GSK1562902A|IM administration
16299084|NCT00652730|Drug|Buspirone HCl|Tablets, 30 mg, single-dose, fasting conditions
16299085|NCT00652730|Drug|Buspirone HCl|Tablets, 30 mg, single-dose, fed conditions
16299086|NCT00652730|Drug|Buspar|Tablets, 30 mg, single-dose, fed conditions
16299087|NCT00652717|Drug|Ezetimibe|Ezetimibe 10 mg daily for 42 days.
16299088|NCT00652717|Drug|simvastatin|simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
16299089|NCT00652704|Drug|Doxycycline monohydrate|Capsules, 100 mg, fed
16299090|NCT00652704|Drug|Monodox|Capsules, 100 mg, fed
16299091|NCT00652704|Drug|Doxycycline Monohydrate|Capsules, 100 mg, fasting
16299092|NCT00652691|Biological|filgrastim|
16299093|NCT00652691|Drug|carboplatin|
16299094|NCT00652691|Drug|cyclophosphamide|
16299095|NCT00652691|Drug|topotecan hydrochloride|
16299096|NCT00652691|Procedure|autologous hematopoietic stem cell transplantation|
16299097|NCT00652691|Procedure|peripheral blood stem cell transplantation|
16299098|NCT00652665|Drug|Leflunomide|Tablets, 20mg, single-dose
16299099|NCT00652665|Drug|ARAVA|Tablets, 20mg,single-dose
16299100|NCT00652652|Drug|nesiritide, furosemide|
16299101|NCT00652639|Drug|Clonazepam|Tablets, 1 mg, single-dose
16299102|NCT00652639|Drug|Klonopin|tablets, 1 mg, single-dose
16299103|NCT00652626|Drug|azacitidine|
16299104|NCT00652613|Radiation|3 Dimensional Radiation Therapy|Radiation with 6 MV photons to dose of 70Gy/ 35#/ 7 weeks
16299105|NCT00652613|Radiation|Intensity Modulated Radiation Therapy|IMRT with 6 MV photons to a dose of 66Gy/30#/ 6 weeks
16299106|NCT00652600|Drug|Propranolol|ER Capsules, 160 mg, single-dose
16299107|NCT00652600|Drug|Inderal-LA|ER Capsules, 160 mg, single-dose
16299108|NCT00652587|Procedure|hepatectomy and transcatheter arterial chemoembolization|partial hepatectomy with adjuvant transcatheter arterial chemoembolization
16299109|NCT00652587|Procedure|hepatectomy|hepatectomy alone
16299110|NCT00652574|Drug|Dasatinib|70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
16299111|NCT00652561|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2
16299112|NCT00652522|Device|ICD/CRT implant|Implantation of a ICD/ CRT device if not yet implanted
16299113|NCT00652522|Procedure|AF ablation|Atrial Fibrillation ablation by pulmonary vein isolation
16299114|NCT00652522|Other|Best Medical Treatment|Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
16299115|NCT00652509|Behavioral|Interactive Dialogue to Educate and Activate (IDEA)|IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients.
16299116|NCT00652509|Behavioral|Individual Education (IE)|IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
16299117|NCT00652496|Drug|Bimatoprost 0.01% ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
16299118|NCT00652496|Drug|Bimatoprost 0.015% formulation 1 ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
16299119|NCT00652496|Drug|Bimatoprost 0.015% formulation 2 ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
16299120|NCT00652496|Drug|Bimatoprost 0.02% ophthalmic solution|One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
16299121|NCT00652496|Drug|Bimatoprost 0.03% ophthalmic solution|Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs
16299122|NCT00652483|Drug|Brimonidine ophthalmic solution 0.1%|1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
16299123|NCT00652483|Drug|Brimonidine ophthalmic solution 0.2%|1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
16299124|NCT00652470|Procedure|Endoscopic Third Ventriculostomy|A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
16299125|NCT00652470|Procedure|CSF Shunt Insertion|The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.
16299126|NCT00652457|Drug|Memantine|10 mg BID x 3 months
16299127|NCT00652444|Drug|ezetimibe|ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
16299128|NCT00652444|Drug|simvastatin|simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
16299129|NCT00652444|Drug|Placebo (Unspecified)|Matching ezetimibe placebo
16299130|NCT00652431|Drug|Vytorin + Niaspan|Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
16299131|NCT00652431|Drug|Vytorin|Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days
16299132|NCT00652431|Drug|Niaspan|Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
16299133|NCT00652418|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)|Magnevist at a dose of 0.1 mmol/kg
16299134|NCT00652418|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)|Magnevist at a dose of 0.2 mmol/kg
16299135|NCT00652405|Dietary Supplement|alcohol|250 ml of white wine (13% vol; ~25 gram of alcohol per day)
16299136|NCT00652405|Dietary Supplement|Placebo|250 ml of mineral water (Brand name: Vittel)
16299137|NCT00652392|Drug|budesonide/formoterol|
16299138|NCT00652392|Drug|budesonide and placebo|
16299139|NCT00652379|Drug|Pegvisomant|Pegvisomant s.c 15-30 mg 2 times a week
16299140|NCT00652379|Drug|Somatostatin analog (lanreotide or octreotide)|Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
16299141|NCT00652366|Drug|Erlotinib, escalating dose|100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily
16299142|NCT00652366|Drug|Erlotinib, standard dose|100mg, PO, once daily
16299143|NCT00652366|Drug|Gemcitabine|1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
16299144|NCT00652353|Other|44-55-66-PM|"The mnemonic 44-55-66-PM helps to remember the components of the Ottawa Ankle and foot Rule.
~44: Is to remember that an X-ray is required if the patients is unable to walk 4 steps at the moment of the Accident AND during the physical examination 55: Is to remember that an X-ray of the foot is required if the patient has pain at the basis of the 5Th metatarsal of at the 5caphoid 66-PM: Is to remember that an X-ray of the ankle is required if the patient has pain in the Posterior of the lateral or medial malleolar"
16299145|NCT00652353|Other|control|Participants will be instructed of the components of the Ottawa Ankle Rule on a standardized sheet
16299146|NCT00652340|Drug|apricoxib/erlotinib|"apricoxib: 100 mg tablets, 400mg/day
~erlotinib: per package insert"
16299147|NCT00652340|Drug|erlotinib/placebo|"erlotinib: per package insert
~placebo: 100 mg tablets, 400 mg/day"
16299148|NCT00652327|Drug|Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin)|ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks
16299149|NCT00652327|Drug|Double Statin (simvastatin, atorvastatin, or pravastatin)|simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks
16299150|NCT00652314|Device|Thrombi-Gel|Applicaton of Hemostatic product during surgery
16299151|NCT00652301|Drug|ezetimibe|ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
16299152|NCT00652301|Drug|Comparator: Placebo (unspecified)|matching placebo tablet. Duration of Treatment 31 Weeks.
16299153|NCT00652301|Drug|simvastatin|simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
16299154|NCT00652288|Drug|Insulin analogs (Lispro and Aspart)|Insulin bolus given through insulin pump
16299155|NCT00652288|Drug|Insulin analogs (Aspart and Detemir)|Drugs given separately
16299156|NCT00652288|Drug|Insulin analogs (Aspart and Detemir)|Drugs given in the same injection
16299157|NCT00652288|Drug|Insulin analogs (Lispro and Glargine)|Drugs given separately
16299158|NCT00652288|Drug|Insulin analogs (Lispro and Glargine)|Drugs given in single injection
16299159|NCT00652275|Biological|MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP|189 children will receive 3 doses of experimental vaccine
16299160|NCT00652275|Biological|Verorab vaccine|189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.
16299161|NCT00652262|Drug|Levitra (Vardenafil, BAY38-9456)|Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.
16299162|NCT00652236|Other|Physiotherapy|The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred
16299163|NCT00652223|Biological|CYT005-AllQbG10|Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
16299164|NCT00652210|Other|Multiphoton microscopy|Use of multiphoton microscopy to diagnose cancer
16299165|NCT00652184|Drug|ARYS-01 (sorivudine) cream 3% or placebo cream|sorivudine cream 3% or placebo cream twice daily for 10 days
16299166|NCT00652184|Drug|placebo|placebo cream and placebo valaciclovir
16299167|NCT00652184|Drug|valaciclovir|active valaciclovir
16299168|NCT00652171|Drug|Lamotrigine|Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
16299169|NCT00652171|Dietary Supplement|Amide|Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
16299170|NCT00652158|Drug|MLN8054|"10 mg doses of MLN8054 were given orally once daily following a schedule of 5 days on/2 days off/5 days on repeated every 28 days"
16299171|NCT00652145|Drug|mesalamine|Increase dose by 2.4gm per day over baseline dose
16299172|NCT00652132|Drug|cisplatin|
16299173|NCT00652132|Drug|sodium thiosulfate|
16299174|NCT00652119|Drug|Paclitaxel|Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
16299175|NCT00652119|Drug|Carboplatin|Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
16299176|NCT00652119|Drug|Avastin|Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.
16299177|NCT00652106|Drug|0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution|0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
16299178|NCT00652106|Drug|Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution|Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
16299179|NCT00652106|Drug|Brimonidine 0.2% ophthalmic solution|Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
16299180|NCT00652093|Drug|opana then darvocet then placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
16299181|NCT00652093|Drug|opana then placebo then darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
16299182|NCT00652093|Drug|placebo then opana then darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
16299183|NCT00652093|Drug|Placebo then darvocet then opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
16299184|NCT00652093|Drug|Darvocet then opana then placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
16299185|NCT00652093|Drug|Darvocet then placebo then opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
16299186|NCT00652080|Drug|API 31510|Topical Cream; 3% active; AM & PM application
16299187|NCT00652054|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.
16299188|NCT00652041|Drug|Bortezomib|Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4
16299189|NCT00652041|Drug|Thalidomide|Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is <Grade 2, dose should be increased to 200 mg/24 h. in day 15
16299190|NCT00652041|Drug|Bortezomib|Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.
16299191|NCT00652028|Drug|Dexmedetomidine, midazolam; fentanyl|Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
16299192|NCT00652002|Drug|budesonide/formoterol|
16299193|NCT00652002|Drug|budesonide|
16299194|NCT00652002|Drug|formoterol|
16299195|NCT00651989|Other|optical coherence tomography foveal thickness measurement|In the same session in one randomly selected eye of each subject three consecutive measurements of foveal thickness were performed using both time-domain OCT and spectral-domain OCT.
16299196|NCT00651976|Drug|letrozole|Take by mouth at a dose of 2.5 mg on days 7-21
16299197|NCT00651976|Other|Blood Collection|Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction
16299278|NCT00651417|Dietary Supplement|Placebo|Placebo tablets orally 3 - 5 times per day as tolerated
16299198|NCT00651976|Procedure|biopsy/lumpectomy/mastectomy|Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis
16299199|NCT00651963|Drug|ezetimibe|"Ezetimibe 10 mg daily was added during 4 weeks.
~The patients continued taking their usual Statin without titrating the dose."
16299200|NCT00651937|Drug|Melphalan|100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.
16299201|NCT00651937|Procedure|Stem Cell Infusion|"Stem Cell Infusion is Day 0.
~Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0
~High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0."
16299202|NCT00651937|Behavioral|Questionnaires|Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
16299203|NCT00651937|Drug|Granulocyte-colony stimulating factor (G-CSF)|5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
16299204|NCT00651937|Procedure|Apheresis|Collection of stem cells from blood collected either through CVC or from a vein in one arm.
16299205|NCT00651924|Behavioral|IVR-based Cognitive-behavior therapy|Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
16299206|NCT00651911|Drug|urate oxidase|First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.
16299207|NCT00651885|Drug|treprostinil dienthanolmine sustained release|UT-15C SR 1mg tablet
16299208|NCT00651885|Drug|Placebo|Placebo
16299209|NCT00651859|Drug|Bimatoprost 0.01% Ophthalmic Solution|Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
16299210|NCT00651859|Drug|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
16299211|NCT00651859|Drug|Bimatoprost Vehicle Ophthalmic Solution|Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
16299212|NCT00651846|Drug|Yasmin (DRSP 3mg/EE 0.03 mg)|The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
16299213|NCT00651846|Drug|Microgynon (LNG 0.15 mg/EE 0.03 mg)|The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
16299214|NCT00651833|Drug|S-1|All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.
16299215|NCT00651820|Drug|Collagenase Santyl|"Dermatome-induced skin wounds treated with drug active.
~Each subject serves as his own control receiving both treatments in parallel."
16299216|NCT00651820|Drug|Collagenase Santyl Vehicle|Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
16299217|NCT00651807|Drug|etonogestrel|Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks
16299218|NCT00651807|Drug|Placebo|Every day one tablet up to 8 weeks
16299219|NCT00651794|Behavioral|Teamwork training|Crew Resource Management (CRM) is an aviation training program mandated for all crew members that teaches human factors concepts, communication skills, and teamwork behaviors that can prevent and manage error. Over the last six years the study team has translated these behaviors to neonatal resuscitation and demonstrated that they can be reliably measured. Adding teamwork instruction to the existing NRP, based upon CRM, may be a method to improve communication, teamwork, and the overall quality of neonatal resuscitation.
16299220|NCT00651794|Behavioral|Standard NRP curriculum|The existing NRP course, taught to most caregivers in the United States who care for newborns, focuses on teaching the technical aspects of neonatal resuscitation with little attention paid to communication and teamwork.
16299221|NCT00651794|Behavioral|Skills practice with low-fidelity mannequin|
16299222|NCT00651794|Behavioral|Skills practice with high-fidelity mannequin|SimBaby mannequins (Laerdal Medical Corp, Stavanger, Norway) were used in the high-fidelity skills stations. These mannequins have simulated heart tones, breath sounds, pulses, and cries.
16299223|NCT00651781|Drug|Bortezomib|2 times per week of Velcade administration.
16299224|NCT00651768|Drug|budesonide/formoterol|
16299225|NCT00651768|Drug|Symbicort pMDI + budesonide HFA pMDI|Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg
16299226|NCT00651755|Drug|Aprepitant|125 mg By Mouth (PO) On Day 1, followed by 80 mg PO Daily On Days 2-3.
16299227|NCT00651755|Drug|Cyclophosphamide|750 mg/m^2 By Vein On Day 1
16299228|NCT00651755|Drug|Doxorubicin|25 mg/m^2 By Vein Over 48 Hours On Days 1-2
16299229|NCT00651755|Drug|Vincristine|2 mg By Vein On Day 1
16299230|NCT00651755|Drug|Prednisone|100 mg PO for 5 Days
16299231|NCT00651755|Drug|Rituximab|375 mg/m^2 By Vein On Day 1.
16299232|NCT00651755|Drug|Ondansetron|8 mg daily for 2 days
16299233|NCT00651742|Drug|S-1|All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.
16299234|NCT00651729|Biological|Botulinum Toxin Type A|Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg
16299235|NCT00651716|Other|flow cytometry|Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry.
16299236|NCT00651716|Other|laboratory biomarker analysis|Identification of gut-homing and skin-homing Treg subsets
16299237|NCT00651716|Other|Data Collection|Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.
16299238|NCT00651703|Biological|CYT004-MelQbG10 + Montanide|
16299239|NCT00651703|Biological|CYT004-MelQbG10 + Montanide + Imiquimod|
16299240|NCT00651703|Biological|CYT004-MelQbG10 + Imiquimod|
16299241|NCT00651703|Biological|CYT004-MelQbG10 intra nodal injection|
16299242|NCT00651690|Biological|Botulinum Toxin Type A|200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18
16299243|NCT00651690|Biological|Placebo|Saline injection on Day 0
16299244|NCT00651677|Procedure|HAL proctectomy|Hand-assisted laparoscopic proctectomy
16299245|NCT00651677|Procedure|"straight laparoscopic proctectomy"|"straight laparoscopic proctectomy"
16299246|NCT00651677|Procedure|Hand-assisted laparoscopic proctectomy|hand-assisted laparoscopic proctectomy
16299247|NCT00651677|Procedure|SL Proctectomy|Straight laparoscopic proctectomy
16299248|NCT00651664|Drug|alisertib|Alisertib (MLN8237) capsules
16299249|NCT00651651|Drug|budesonide/formoterol|
16299250|NCT00651651|Drug|budesonide|
16299251|NCT00651651|Drug|formoterol|
16299252|NCT00651638|Drug|Treatment with ARQ 197|Treatment with ARQ 197
16299253|NCT00651625|Device|Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001|The RPD is a safety syringe device that is hypothesized to be safer, less painful, and more effective for patients undergoing a syringe and needle procedure (please see arm #1).
16299254|NCT00651625|Device|conventional syringe - BD Ref 309604|the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.
16299255|NCT00651612|Drug|Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution|Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
16299256|NCT00651612|Drug|Concurrent brimonidine 0.2% and 0.5% timolol|Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)
16299257|NCT00651599|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
16299258|NCT00651599|Drug|Placebo|Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
16299259|NCT00651586|Drug|Gatifloxacin 0.3% ophthalmic solution|Gatifloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
16299260|NCT00651586|Drug|Ciprofloxacin 0.3% ophthalmic solution|Ciprofloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
16299261|NCT00651573|Procedure|Blood transfusion at hematocrit value less than 24%|transfusion
16299262|NCT00651573|Procedure|Blood transfusion at hematocrit value less than 28%|transfusion
16299263|NCT00651560|Drug|ezetimibe (+) simvastatin|ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.
16299264|NCT00651547|Drug|budesonide/formoterol|
16299265|NCT00651547|Drug|budesonide|
16299266|NCT00651547|Drug|formoterol|
16299267|NCT00651534|Drug|Ronacaleret|
16299268|NCT00651508|Drug|KOS-1584|25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.
16299269|NCT00651495|Behavioral|Patient decision aids for chronic conditions|Videos providing comprehensive information about chronic disease management
16299270|NCT00651482|Drug|Everolimus|
16299271|NCT00651482|Drug|Bevacizumab|
16299272|NCT00651469|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
16299273|NCT00651469|Drug|Placebo|The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
16299274|NCT00651456|Drug|Standard Chemotherapy (Pemetrexed and Cisplatin)|"Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
~Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)"
16299275|NCT00651456|Drug|Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab|"Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
~Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
~Bevacizumab 15 mg/kg D1 (D1=D22, until progression)"
16299276|NCT00651443|Drug|Galiximab|Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.
16299277|NCT00651417|Dietary Supplement|Organic Germanium|Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated
16299279|NCT00651404|Drug|Ezetimibe|oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
16299280|NCT00651404|Drug|Placebo|oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
16299281|NCT00651391|Drug|Ezetimibe + Simvastatin|oral tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily in the evening for 12 weeks
16299282|NCT00651391|Drug|Simvastatin|oral simvastatin 20 mg once daily in the evening for 12 weeks
16299283|NCT00651391|Drug|Placebo|oral placebo once daily in the evening for 12 weeks
16299284|NCT00651378|Drug|Rosuvastatin|oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
16299285|NCT00651378|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
16299286|NCT00651378|Drug|Double Atorvastatin|oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
16299287|NCT00651365|Drug|JNJ-38877605|
16299288|NCT00651352|Drug|4 mg nicotine lozenge|marketed formulation
16299289|NCT00651352|Drug|2 mg nicotine lozenge|marketed formulation
16299290|NCT00651352|Drug|2 mg nicotine prototype|2 mg
16299291|NCT00651352|Drug|4 mg nicotine prototype|4 mg
16299292|NCT00651339|Drug|botox|botox injection
16299293|NCT00651326|Drug|bicalutamide|
16299294|NCT00651326|Drug|buserelin|
16299295|NCT00651326|Drug|flutamide|
16299296|NCT00651326|Drug|goserelin|
16299297|NCT00651326|Drug|leuprolide acetate|
16299298|NCT00651326|Procedure|neoadjuvant therapy|
16299299|NCT00651326|Procedure|quality-of-life assessment|
16299300|NCT00651326|Radiation|radiation therapy|"46 Gy in 23 fractions over < 5 weeks.
~Boost:
~24-28 Gy in 12-14 fractions over < 3 weeks"
16299301|NCT00651326|Drug|Docetaxel|
16299302|NCT00651313|Drug|Lidocaine|Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
16299303|NCT00651313|Drug|Placebo|Placebo vaginal gel administered once daily for 4 days
16299304|NCT00651300|Drug|Parecoxib/Valdecoxib|A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
16299305|NCT00651300|Drug|Placebo|A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
16299306|NCT00651287|Drug|quinapril 20 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks
16299307|NCT00651287|Drug|quinapril 20 mg plus hydrochlorothiazide 12.5 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks
16299308|NCT00651287|Drug|quinapril 40 mg|Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks
16299309|NCT00651274|Drug|Ezetimibe|oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
16299310|NCT00651274|Drug|Placebo|oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
16299311|NCT00651261|Drug|cytarabine|Given IV
16299312|NCT00651261|Drug|daunorubicin|Given IV
16299313|NCT00651261|Drug|midostaurin|Given orally
16299314|NCT00651261|Other|placebo|Given orally
16299315|NCT00651261|Drug|dexamethasone acetate|ocular medication administration
16299316|NCT00651235|Drug|Losartan and Atenolol or Propranolol|"50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children.
~Losartan is 100 mg/day for adult and 50 mg/day for children."
16299317|NCT00651235|Drug|Atenolol or Propranolol|The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
16299318|NCT00651222|Other|No intervention was required|Death records were reviewed, therefore, there was no intervention
16299319|NCT00651209|Drug|Tenofovir|All patients receive 600 mg/day, oral telbivudine for 24 weeks. Patients with non-detectable HBV DNA continue 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 1) Patients with detectable HBV DNA receive 300 mg/day, oral tenofovir plus 600 mg/day, oral telbivudine for the remaining treatment period (Sub-group 2)
16299320|NCT00651183|Drug|Pramipexole immediate release|
16299321|NCT00651157|Biological|wild-type reovirus|Given IV: Administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle.
16299322|NCT00651144|Drug|Ezetimibe + Rosuvastatin|oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
16299323|NCT00651144|Drug|Rosuvastatin|oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
16299324|NCT00651144|Drug|Placebo|oral tablets; two ezetimibe placebo once daily for 14 days
16299325|NCT00651144|Drug|Ezetimibe|oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
16299326|NCT00651131|Drug|daptomycin|daptomycin i.v. 4 mg/kg q24h for 7-14 days
16299327|NCT00651118|Drug|Placebo|placebo
16299328|NCT00651118|Drug|azelastine Hcl|azelastine Hcl 548 mcg
16299329|NCT00651118|Drug|azelastineHcl / fluticasone propionate|azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
16299330|NCT00651118|Drug|fluticasone propionate|fluticasone propionate 200 mcg
16299331|NCT00651105|Drug|Vildagliptin|
16299332|NCT00651105|Drug|Placebo|
16299333|NCT00651092|Procedure|bilateral nasal inferior turbinectomy|the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
16299334|NCT00651092|Procedure|endoscopic submucosal resection of the inferior turbinates|surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates
16299335|NCT00651079|Drug|GSK1247303|
16299936|NCT00646958|Drug|Radezolid|450mg PO QD
16299336|NCT00651066|Drug|rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1|3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg TPW 3 wks switch to 150 mg OD 4 wks);
16299337|NCT00651066|Drug|rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2|3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);
16299338|NCT00651053|Device|EUS|Sensitivity and specificity of EUS will be compared with PFT as reference standard.
16299339|NCT00651040|Drug|Prednisone|Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
16299340|NCT00651040|Drug|Methotrexate|MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
16299341|NCT00651027|Drug|PF-868554|200 mg, Child-Pugh Class A
16299342|NCT00651027|Drug|PF-868554|200 mg, Child-Pugh Class B
16299343|NCT00651027|Drug|PF-868554|200 mg, healthy volunteers
16299344|NCT00651014|Drug|Ezetimibe|oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
16299345|NCT00651014|Drug|Placebo|oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
16299346|NCT00650988|Procedure|Cryospray Ablation|Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.
16299347|NCT00650975|Device|Laser Thromboablation|Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
16299348|NCT00650975|Device|PTCA (Direct Stenting)|Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
16299349|NCT00650962|Other|cardiopulmonary resuscitation|10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
16299350|NCT00650962|Other|Rhythm analysis|Rhythm analysis as soon as AED is ready
16299351|NCT00650949|Drug|CYT997|Escalating doses (100mg/m^2 to 150mg/m^2), 24-hour intravenous infusion on Day 2 of a 21-day cycle (Phase Ib component). Dose selected in Phase Ib component to be used for Phase II component.
16299352|NCT00650949|Drug|Carboplatin|Intravenous infusion over 1 hour at area under the concentration-time curve (AUC)=5 on Day 1 of a 21-day cycle
16299353|NCT00650936|Device|AMPLATZER Septal Occluder|AMPLATZER Septal Occluder
16299354|NCT00650923|Drug|ziv-aflibercept|Given IV
16299355|NCT00650923|Procedure|radiation therapy|Undergo RT
16299356|NCT00650923|Drug|temozolomide|Given PO
16299357|NCT00650923|Procedure|pharmacological study|Correlative studies
16299358|NCT00650923|Procedure|laboratory biomarker analysis|Correlative studies
16299359|NCT00650910|Drug|lapatinib|1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10.
16299360|NCT00650910|Drug|Digoxin|0.5mg on Days 1 and 9
16299361|NCT00650897|Drug|Escitalopram|10-20 mg once daily
16299362|NCT00650884|Device|Ankle Dorsiflexion Dynasplint System|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.
16299363|NCT00650871|Drug|GW679769|
16299364|NCT00650871|Drug|Placebo|
16299365|NCT00650858|Drug|tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)|0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
16299366|NCT00650845|Drug|Dotarem®-enhanced MRI|Single IV administration before MRI exam
16299367|NCT00650845|Other|non-enhanced MRI|non injected MRI
16299368|NCT00650832|Drug|TMC114; darunavir; Prezista|
16299369|NCT00650819|Drug|Ezetimibe + Simvastatin|ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks
16299370|NCT00650819|Drug|Simvastatin|simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks
16299371|NCT00650819|Drug|Ezetimibe|Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks
16299372|NCT00650806|Drug|Canagliflozin (JNJ-28431754)|One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
16299373|NCT00650806|Drug|Placebo|One matching placebo capsule orally once daily for 12 weeks.
16299374|NCT00650793|Drug|Extended Release OROS® Paliperidone|
16299375|NCT00650767|Drug|ARRY-438162, MEK inhibitor; oral|multiple dose, single schedule
16299376|NCT00650767|Drug|Placebo; oral|matching placebo
16299377|NCT00650754|Dietary Supplement|Dehydroepiandrosterone|25 mg PO TID
16299378|NCT00650754|Other|Placebo|Placebo
16299379|NCT00650728|Procedure|placing gastric tube|
16299380|NCT00650715|Device|Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands|Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. The Whole-body vibration intensity was kept constant at 30 Hz of frequency and 2 mm of amplitude.
16299381|NCT00650715|Device|Placebo Whole-body vibration exercise|Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. All exercises were performed without the influence of a vibratory stimulus.
16299382|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
16299383|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
16299384|NCT00650702|Drug|Latanoprost-PPDS|Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
16299385|NCT00650689|Drug|Ezetimibe + Atorvastatin|oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
16299386|NCT00650689|Drug|Atorvastatin|oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
16299387|NCT00650663|Drug|Ezetimibe + Simvastatin|oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks
16299388|NCT00650663|Drug|Simvastatin|oral tablet; simvastatin 20 mg once daily for 12 weeks
16299389|NCT00650637|Drug|Calcium Carbonate|Calcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12
16299390|NCT00650637|Drug|nelfinavir|1250 mg twice a day
16299391|NCT00650637|Drug|lamivudine|lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
16299392|NCT00650637|Drug|loperamide|If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
16299393|NCT00650637|Other|Calcium carbonate not administered|Prophylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
16299394|NCT00650637|Drug|nelfinavir|nelfinavir 1250 mg twice a day
16299395|NCT00650637|Drug|lamivudine + zidovudine|lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
16299396|NCT00650624|Drug|valdecoxib|valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
16299397|NCT00650624|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
16299398|NCT00650624|Drug|valdecoxib|valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
16299399|NCT00650624|Drug|placebo|placebo tablet by mouth once daily in the morning for 6 weeks
16299400|NCT00650611|Drug|Ziprasidone|"Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.
~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."
16299401|NCT00650611|Drug|Ziprasidone|"Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.
~Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1."
16299402|NCT00650598|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
16299403|NCT00650598|Drug|diclofenac|diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
16299404|NCT00650585|Behavioral|Project ALERT|Project ALERT (Adolescent Learning Experiences in Resistance Training) is a drug prevention curriculum designed for middle-school students (11 to 14 years old). The 11 lessons in the first year and 3 booster lessons in the second year focus on alcohol, tobacco, marijuana, and inhalants - the substances that adolescents are most likely to use. Project ALERT uses participatory activities and videos to help motivate youth to avoid drug use, to teach youth skills and strategies to resist peer pressures to use drugs, and to establish social norms against drug-use. More information about Project ALERT may be found at http://www.projectalert.best.org/.
16299405|NCT00650572|Drug|ARRY-380, HER2 inhibitor; oral|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
16299406|NCT00650559|Procedure|Chest wall enlargement|Widening sternotomy
16299407|NCT00650546|Drug|Exenatide|5 mcg twice a day titrated to 10 mcg twice a day
16299408|NCT00650533|Drug|Glimepiride Tablets 1 mg|1mg, single dose fed
16299409|NCT00650533|Drug|Amaryl® Tablets 1 mg|1mg, single dose fed
16299410|NCT00650520|Drug|BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg|4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
16299411|NCT00650520|Drug|Parlodel® (bromocriptine mesylate) capsules, USP 5 mg|4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
16299412|NCT00650507|Procedure|Remote ischemic preconditioning (RIPC)|The RIPC stimulus will be delivered in the OR prep room after the induction of anesthesia (while the anesthesiologist and staff are inserting vascular cannulae and preparing the patient for surgery). Whenever possible, the left lower limb will be selected for delivery of the stimulus. An appropriate sized cuff will be selected and connected to a hand aneroid sphygmomanometer. A second cuff and hand aneroid sphygmomanometer will be placed beside the one connected to the study subject. The cuff on the limb will be inflated and deflated to provide a total of four cycles of limb ischemia and reperfusion.
16299413|NCT00650507|Procedure|SHAM|For this group, the procedure will be identical for that described for the RIPC stimulus, with the exception that the blood pressure cuff placed on the subject will not be inflated, but the second cuff, that has been placed beside, will be inflated.
16299414|NCT00650494|Drug|Valacyclovir Hydrochloride Tablets 1000mg|1000mg, single dose fed
16299415|NCT00650494|Drug|Valtrex® 1000 mg|1000mg, single dose fed
16299416|NCT00650481|Drug|Oxybutynin Chloride Extended-release Tablets 5 mg|4x5mg, single dose fasting
16299417|NCT00650481|Drug|Ditropan XL® Tablets 5 mg|4x5mg, single dose fasting
16299418|NCT00650468|Drug|tacrolimus|Oral
16299419|NCT00650468|Drug|CellCept|IV or Oral
16299420|NCT00650468|Drug|steroids (methylprednisone or prednisone)|IV or Oral
16299421|NCT00650455|Drug|valdecoxib|valdecoxib 10 mg tablet once daily for 12 weeks
16299422|NCT00650455|Drug|naproxen|naproxen 500 mg capsule twice daily for 12 weeks
16299423|NCT00650455|Drug|placebo|placebo tablet every morning and capsule every evening for 12 weeks
16299424|NCT00650442|Drug|Estradiol Transdermal System Placebo - Alternate Adhesive|single application
16299425|NCT00650442|Drug|Estradiol Transdermal System Placebo - Current Adhesive|single application
16299485|NCT00650065|Drug|Cetirizine HCl Tablets 10 mg|10mg, single dose fasting
16299486|NCT00650065|Drug|Zyrtec® Tablets 10 mg|10mg, single dose fasting
16299426|NCT00650429|Drug|Ziprasidone|IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
16299427|NCT00650416|Drug|Carvedilol Tablets 12.5 mg|12.5mg, single dose fasting
16299428|NCT00650416|Drug|Coreg® Tablets 12.5 mg|12.5mg, single dose fasting
16299429|NCT00650403|Drug|Paroxetine hydrochloride 40 mg tablet|40mg, single dose fed
16299430|NCT00650403|Drug|Paxil® 40 mg Tablet|40mg, single dose fed
16299431|NCT00650390|Biological|adalimumab|40 mg adalimumab every other week
16299432|NCT00650377|Drug|Finasteride Tablets 5 mg|5mg, single dose fed
16299433|NCT00650377|Drug|Proscar® Tablets 5 mg|5mg, single dose fed
16299434|NCT00650364|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fasting
16299435|NCT00650364|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fasting
16299436|NCT00650351|Drug|Ciprofloxacin Extended-Release Tablets 1000 mg|1000mg, single dose fed
16299437|NCT00650351|Drug|Cipro® XR Tablets 1000 mg|1000mg, single dose fed
16299438|NCT00650338|Drug|DE-104 ophthalmic solution, low concentration|Topical ocular application
16299439|NCT00650338|Drug|DE-104 ophthalmic solution, medium concentration|Topical ocular application
16299440|NCT00650338|Drug|DE-104 ophthalmic solution, high concentration|Topical ocular application
16299441|NCT00650338|Drug|Placebo|placebo
16299442|NCT00650338|Drug|0.005% latanoprost|Topical ocular application
16299443|NCT00650325|Drug|Sertraline Hydrochloride Tablets 100 mg|100mg, single dose fasting
16299444|NCT00650325|Drug|Zoloft® Tablets 100 mg|100mg, single dose fasting
16299445|NCT00650312|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fasting
16299446|NCT00650312|Drug|Glucophage® XR Tablets 500 mg|500mg, single dose fasting
16299447|NCT00650299|Drug|Alprazolam Extended-release Tablets 3 mg|3mg, single dose fed
16299448|NCT00650299|Drug|Xanax XR® Tablets 3 mg|3mg, single dose fed
16299449|NCT00650286|Drug|Modafinil Tablets 200 mg|200mg, single dose fed
16299450|NCT00650286|Drug|Provigil® Tablets 200 mg|200mg, single dose fed
16299451|NCT00650273|Drug|Azithromycin Tablets 600 mg|600mg, single dose fasting
16299452|NCT00650273|Drug|Zithromax® Tablets 600 mg|600mg, single dose fasting
16299453|NCT00650260|Device|Dynatherm Medical vitalHEAT Temperature Management System vH2|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical.
16299454|NCT00650260|Device|Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)|The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket.
16299455|NCT00650247|Drug|Sumatriptan Succinate Tablets 100 mg|100mg, single dose fed
16299456|NCT00650247|Drug|Imitrex® Tablets 100 mg|100mg, single dose fed
16299457|NCT00650234|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fasting
16299458|NCT00650234|Drug|Glucophage® XR Tablets 500 mg|500mg, single dose fasting
16299459|NCT00650221|Drug|Pravastatin|Single-dose 80 mg immediate-release oral tablet
16299460|NCT00650221|Drug|Pravastatin|Single-dose 80 mg immediate-release tablet
16299461|NCT00650208|Drug|Lamotrigine Tablets 25 mg|2x25mg, single dose fasting
16299462|NCT00650208|Drug|Lamictal® Tablets 25 mg|2x25mg, single dose fasting
16299463|NCT00650195|Drug|Metolazone Tablets 10 mg|10mg, single dose fasting
16299464|NCT00650195|Drug|Zaroloxyn® Tablets 10 mg|10mg, single dose fasting
16299465|NCT00650182|Drug|fentanyl; naltrexone|
16299466|NCT00650169|Drug|Clopidogrel Bisulfate Tablets 75 mg|75mg, single dose fed
16299467|NCT00650169|Drug|Plavix® Tablets 75 mg|75mg, single dose fed
16299468|NCT00650156|Biological|adalimumab|40 mg single sc dose
16299469|NCT00650156|Biological|adalimumab|80 mg single sc dose
16299470|NCT00650143|Drug|Lenograstim (GRANOCYTE)=GCSF|10 µg/kg/d s.c. for 5 days divided in two dosages per day
16299471|NCT00650143|Drug|Sitagliptin (Januvia)|100 mg p.o. per day for 28 days
16299472|NCT00650143|Drug|Sodium Chloride (NaCl) 0.9 %|applied s.c. twice a day for 5 days
16299473|NCT00650143|Drug|Gelatin|One capsule p.o. per day for 28 days
16299474|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)|single application
16299475|NCT00650117|Drug|Duragesic 25 mcg/h + Scotch Duct Tape (3M)|single application
16299476|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)|single application
16299477|NCT00650117|Drug|Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)|single application
16299478|NCT00650117|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)|single application
16299479|NCT00650117|Drug|Duragesic 25 mcg/h + Microfoam Tape (3M)|single application
16299480|NCT00650104|Drug|Ropinirole XL (formerly CR)|Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
16299481|NCT00650091|Drug|N-acetylcysteine (NAC)|Participants will receive 600 mg of NAC three times a day.
16299482|NCT00650091|Drug|Placebo|Participants will receive placebo each day.
16299483|NCT00650078|Drug|MR prednisone|1 x 5 mg daily
16299484|NCT00650078|Drug|Placebo|1x daily
16299487|NCT00650052|Drug|Zonisamide Capsules 100 mg|100mg, single dose fasting
16299488|NCT00650052|Drug|Zonegran® Capsules 100 mg|100mg, single dose fasting
16299489|NCT00650039|Drug|placebo|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.
16299490|NCT00650039|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
16299491|NCT00650039|Drug|valdecoxib|valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
16299492|NCT00650026|Biological|adalimumab|40 mg adalimumab every other week
16299493|NCT00650013|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fed
16299494|NCT00650013|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fed
16299495|NCT00650000|Drug|Modafinil Tablets 200 mg|200mg, single dose fasting
16299496|NCT00650000|Drug|Provigil® Tablets 200 mg|200mg, single dose fasting
16299497|NCT00649987|Drug|Albuterol Sulfate Extended-Release Tablets 8 mg|8mg, single dose fed
16299498|NCT00649987|Drug|VoSpire® ER Tablets 8 mg|8mg, single dose fed
16299499|NCT00649974|Drug|Valacyclovir Hydrochloride Tablets 1000 mg|1000mg, single dose fasting
16299500|NCT00649974|Drug|Valtrex® Tablets 1000 mg|1000mg, single dose fasting
16299501|NCT00649961|Drug|Melatonin injection|"A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found.
~Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr."
16299502|NCT00649948|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fed
16299503|NCT00649948|Drug|Glucophage XR 500 mg|500mg, single dose fed
16299504|NCT00649935|Drug|Azithromycin Tablets 600 mg|600mg, single dose fed
16299505|NCT00649935|Drug|Zithromax® Tablets 600 mg|600mg, single dose fed
16299506|NCT00649922|Biological|adalimumab|80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
16299507|NCT00649922|Biological|placebo|2 injections Day 1, 1 injection Days 15 and 29
16299508|NCT00649922|Biological|adalimumab|40 mg adalimumab every other week
16299509|NCT00649896|Drug|Mylan Estradiol Transdermal System 0.025 mg/day|
16299510|NCT00649896|Drug|Climara® Transdermal System 0.025 mg/day|
16299511|NCT00649883|Biological|Influenza Trivalent Inactivated vaccines Novartis|Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
16299512|NCT00649883|Biological|Influenza Trivalent Inactivated vaccines|Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
16299513|NCT00649870|Drug|Valacyclovir Hydrochloride Tablets 1000 mg|1000mg, single dose fed
16299514|NCT00649870|Drug|Valtrex® Tablets 1000 mg|1000mg, single dose fed
16299515|NCT00649857|Drug|Cetirizine HCl Tablets 10 mg|10mg, single dose fed
16299516|NCT00649857|Drug|Zyrtec® 10 mg|10mg, single dose fed
16299517|NCT00649844|Drug|Clozapine|Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks
16299518|NCT00649844|Drug|Ziprasidone|Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks
16299519|NCT00649831|Drug|Amoxicillin/clavulinic acid|amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
16299520|NCT00649831|Drug|Azithromycin|Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
16299521|NCT00649818|Drug|Lorazepam Tablets 2 mg|2mg, single dose fasting
16299522|NCT00649818|Drug|Ativan Tablets 2 mg|2mg, single dose fasting
16299523|NCT00649805|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose applesauce
16299524|NCT00649805|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose applesauce
16299525|NCT00649792|Drug|Fampridine-SR|Tablets, 10 mg, BID (twice daily)
16299526|NCT00649779|Drug|albuterol sulfate extended-release 8 mg tablets|8mg, single dose fasting
16299527|NCT00649779|Drug|VoSpire™ ER 8 mg tablets|8mg, single dose fasting
16299528|NCT00649766|Behavioral|tailored newsletter|Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease
16299529|NCT00649766|Behavioral|targeted newsletter|Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.
16299530|NCT00649753|Procedure|Category II Pelvic Blocking|Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction.
16299531|NCT00649753|Procedure|Category II Pelvic Blocking and Cranial|Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction. During pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
16299532|NCT00649753|Procedure|Cranial Only|Without pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
16299533|NCT00649740|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose fasting
16299534|NCT00649740|Drug|Topamax® Sprinkle Capsule 25 mg|25mg, single dose fasting
16299535|NCT00649727|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fed
16299536|NCT00649727|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fed
16299537|NCT00649714|Drug|Zonisamide Capsules 100 mg|100mg, single dose fed
16299538|NCT00649714|Drug|Zonegran® Capsules 100 mg|100mg, single dose fed
16299539|NCT00649701|Behavioral|Standard Text-Based Prevention Web Page|A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.
16299540|NCT00649701|Behavioral|The Morning After|A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
16299541|NCT00649701|Behavioral|Talking About HIV|A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
16299542|NCT00649701|Behavioral|Both Videos|Morning After and Talking About HIV videos
16299543|NCT00649688|Drug|Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg|100/50mg, single dose fasting
16299544|NCT00649688|Drug|Lopressor HCT® Tablets 100/50 mg|100/50mg, single dose fasting
16299545|NCT00649675|Drug|Meloxicam Tablets 15 mg|15mg, single dose fed
16299546|NCT00649675|Drug|Mobic® Tablets 15 mg|15mg, single dose fed
16299547|NCT00649662|Drug|Ciprofloxacin Extended-Release Tablets 1000 mg|1000mg, single dose fasting
16299548|NCT00649662|Drug|Cipro® XR Tablets 1000 mg|1000mg, single dose fasting
16299549|NCT00649649|Drug|Quinapril Hydrochloride Tablets 40 mg|40mg, single dose fed
16299550|NCT00649649|Drug|Accupril® Tablets 40 mg|40mg, single dose fed
16299551|NCT00649636|Drug|Fluoxetine Capsules 40 mg|40mg, single dose fasting
16299552|NCT00649636|Drug|Prozac Pulvules 40 mg|40mg, single dose fasting
16299553|NCT00649623|Drug|Olmesartan Medoxomil Tablets 40 mg|40mg, single dose fasting
16299554|NCT00649623|Drug|Benicar® Tablets 40 mg|40mg, single dose fasting
16299555|NCT00649610|Drug|valdecoxib|valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
16299556|NCT00649610|Drug|diclofenac|diclofenac 75 mg twice daily (BID) for 7 days
16299557|NCT00649597|Drug|Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fasting
16299558|NCT00649597|Drug|Lotensin HCT® Tablets 20 mg/25 mg|20/25mg, single dose fasting
16299559|NCT00649584|Drug|SGN-35|IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
16299560|NCT00649584|Drug|gemcitabine|IV; 1000 mg/m2 weekly 3 out of 4 weeks
16299561|NCT00649571|Drug|Doxycycline Monohydrate Tablets (100 mg|100mg, single dose fasting
16299562|NCT00649571|Drug|Adoxa Tablets 100 mg|100mg, single dose fasting
16299563|NCT00649558|Drug|Pioglitazone HCl Tablets 45 mg|45mg, single dose fasting
16299564|NCT00649558|Drug|Actos® Tablets 45 mg|45mg, single dose fasting
16299565|NCT00649545|Biological|adalimumab|40 mg every other week
16299566|NCT00649532|Drug|Ondansetron Tablets 24 mg|24mg, single dose fasting
16299567|NCT00649532|Drug|Zofran® Tablets 24 mg|24mg, single dose fasting
16299568|NCT00649519|Drug|Amlodipine and Benazepril HCl Capsules 10 mg/20 mg|10/20mg, single dose fasting
16299569|NCT00649519|Drug|Lotrel® Capsules 10 mg/20 mg|10/20mg, single dose fasting
16299570|NCT00649506|Drug|Nitrofurantoin Macrocrystals 100 mg Capsules|100mg, single dose fed
16299571|NCT00649506|Drug|Macrodantin® 100 mg Capsules|100mg, single dose fed
16299572|NCT00649493|Drug|Rabeprazole Sodium Tablets 20 mg|20mg, single dose fed
16299573|NCT00649493|Drug|Aciphex® Tablets 20 mg|20mg, single dose fed
16299574|NCT00649480|Drug|BALSALAZIDE DISODIUM CAPSULES, 750 MG|3x750mg, single dose fed
16299575|NCT00649480|Drug|COLAZAL® Capsules 750 mg|3x750mg, single dose fed
16299576|NCT00649467|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose applesauce
16299577|NCT00649467|Drug|Topamax® Sprinkle Capsules 25 mg|25mg, single dose applesauce
16299578|NCT00649454|Drug|Glipizide and Metformin HCl Tablets 5 mg/500 mg|5/500mg, single dose fasting
16299579|NCT00649454|Drug|Metaglip® Tablets 5 mg/500 mg|5/500mg, single dose fasting
16299580|NCT00649441|Drug|Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fasting
16299581|NCT00649441|Drug|Accuretic™ Tablets 20 mg/25 mg|20/25mg, single dose fasting
16299582|NCT00649428|Biological|Autologous Human Fibroblast (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Three injection treatments administered 5 ± 1 weeks apart on each side of the face."
16299583|NCT00649428|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Three injection visits administered 5 ± 1 weeks apart on each side of the face."
16299584|NCT00649415|Drug|piroxicam|piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
16299585|NCT00649415|Drug|valdecoxib|valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle
16299586|NCT00649402|Drug|Amlodipine and Benazepril HCl Capsules 10 mg/20 mg|10/120mg, single dose fed
16299587|NCT00649402|Drug|Lotrel® Capsules 10 mg/20 mg|10/20mg, single dose fed
16299588|NCT00649389|Drug|Olmesartan medoxomil|40mg olmesartan medoxomil
16299589|NCT00649389|Drug|Amlodipine|Amlodipine 10mg
16299590|NCT00649389|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25mg
16299591|NCT00649376|Drug|Fexofenadine Tablets 180 mg|180mg, single dose fasting
16299592|NCT00649376|Drug|Allegra® Tablets 180 mg|180mg, single dose fasting
16299593|NCT00649363|Drug|Ondansetron Orally Disintegrating Tablets 8 mg|8mg, single dose fasting
16299594|NCT00649363|Drug|Zofran ODT® Tablets 8 mg|8mg, single dose fasting
16299595|NCT00649350|Drug|Metformin Hydrochloride ER Tablets 750 mg|750mg, single dose fed
16299596|NCT00649350|Drug|Glucophage XR 750 mg|750mg, single dose fed
16299647|NCT00648973|Drug|Pseudoephedrine 120 mg|"Three times daily: two diphenhydramine-matching placebo capsules
~Twice daily: one pseudoephedrine 120 mg tablet"
16299648|NCT00648960|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral tablet
16299597|NCT00649337|Procedure|Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography|"AWBU is a computer-based system for performing and recording ultrasound scans of the whole breast. The transducer of any suitable high-resolution compound ultrasound equipment is attached to a mechanical arm guided by computer, and images are acquired in longitudinal rows, overlapping to assure complete coverage. The mechanical arm controls transducer speed and position, with a technician maintaining appropriate contact pressure and orientation vertical to the skin. Approximately 150-300 images per row are immediately displayed on the AWBU monitor, then permanently stored.
~The AWBU software creates a continuous ciné loop of the images, creating the appearance of real-time scanning. With spatial registration, any point on an image can be identified as a distance from the nipple in a specific radius. Image review is optimized by playback on a high-resolution monitor to allow compressed image size, 3-D reconstruction, and adjustment of contrast, brightness and review speed."
16299598|NCT00649324|Drug|Hydrochlorothiazide Tablets 50 mg|50mg, single dose fasting
16299599|NCT00649324|Drug|Hydrochlorothiazide Tablets (50 mg|50mg, single dose fasting
16299600|NCT00649311|Drug|eplerenone|Eplerenone 50 mg oral film-coated tablet once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to eplerenone 100 mg oral film-coated tablet once daily for 4 weeks.
16299601|NCT00649311|Drug|Losartan|Losartan 50 mg oral capsule once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to losartan 100 mg oral capsule once daily for 4 weeks
16299602|NCT00649298|Procedure|haemodialysis|Comparison of different weekly duration of haemodialysis treatment
16299603|NCT00649285|Drug|Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg|100mg, single dose fed
16299604|NCT00649285|Drug|Macrobid® Capsules 100 mg|100mg, single dose fed
16299605|NCT00649272|Drug|Oxybutynin Chloride Extended-Release Tablets, 15 mg|15mg, single dose fasting
16299606|NCT00649272|Drug|Ditropan XL® Extended-release tablets, 15 mg|15mg, single dose fasting
16299607|NCT00649259|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fed
16299608|NCT00649259|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fed
16299609|NCT00649233|Drug|Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg|100/50mg, single dose fed
16299610|NCT00649233|Drug|Lopressor HCT® Tablets 100/50 mg|100/50mg, single dose fed
16299611|NCT00649220|Drug|Memantine|memantine tablets, twice a day (bid), for 20 weeks
16299612|NCT00649207|Drug|ABT-888|Oral Capsules
16299613|NCT00649207|Radiation|Whole Brain Radiation Therapy|15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
16299614|NCT00649194|Drug|Rabeprazole Sodium Delayed-Release Tablets 20 mg|20mg, single dose fed
16299615|NCT00649194|Drug|Aciphex® Tablets 20 mg|20mg, single dose fed
16299616|NCT00649181|Drug|Metolazone Tablets 5 mg|2x5mg, single dose fasting
16299617|NCT00649181|Drug|Zaroloxyn® Tablets 5 mg|2x5mg, single dose fasting
16299618|NCT00649168|Drug|BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg|2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
16299619|NCT00649168|Drug|Parlodel® (bromocriptine mesylate) capsules, USP 5 mg|2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
16299620|NCT00649155|Drug|Ciprofloxacin Extended-Release Tablets 500 mg|500mg, single dose fasting
16299621|NCT00649155|Drug|Cipro® XR Tablets (500 mg|500mg, single dose fasting
16299622|NCT00649142|Procedure|Open sutured mesh repair|Open sutured mesh repair
16299623|NCT00649142|Procedure|Laparoscopic mesh glue fixation|Laparoscopic mesh glue fixation
16299624|NCT00649129|Drug|Oxybutynin Chloride ER Tablets 10 mg|2x10mg, single dose fasting
16299625|NCT00649129|Drug|Ditropan XL® Tablets 10 mg|2x10mg, single dose fasting
16299626|NCT00649116|Drug|Metoprolol Tartrate Tablets 100 mg|100mg, single dose fed
16299627|NCT00649116|Drug|Lopressor® Tablets 100 mg|100mg, single dose fed
16299628|NCT00649103|Drug|Quinapril Hydrochloride Tablets 40 mg|40mg, single dose fasting
16299629|NCT00649103|Drug|Accupril® Tablets 40 mg|40mg, single dose fasting
16299630|NCT00649090|Drug|exemestane|Exemestane 25 mg oral tablet once daily for a maximum of 3 years
16299631|NCT00649077|Drug|Meloxicam Tablets 15 mg|15mg, single dose fasting
16299632|NCT00649077|Drug|Mobic® Tablets 15 mg|15mg, single dose fasting
16299633|NCT00649064|Drug|Ziprasidone|Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
16299634|NCT00649051|Drug|Metolazone Tablets 2.5 mg|4x2.5mg, single dose fasting
16299635|NCT00649051|Drug|Zaroloxyn® Tablets 2.5 mg|4x2.5mg, single dose fasting
16299636|NCT00649038|Drug|Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fed
16299637|NCT00649038|Drug|Lotensin HCT® Tablets 20 mg/25 mg|20/25mg, single dose fed
16299638|NCT00649025|Drug|FlutiForm 250/10|SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16299639|NCT00649025|Drug|SKP-Fluticasone|SKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
16299640|NCT00649025|Drug|Flovent Fluticasone HFA|Flovent 250 ug HFA is a pMDI that delivers after priming 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
16299641|NCT00649012|Drug|Pioglitazone HCl Tablets 45 mg|45mg, single dose fed
16299642|NCT00649012|Drug|Actos® Tablets 45 mg|45mg, single dose fed
16299643|NCT00648999|Drug|lopinavir/ritonavir|lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
16299644|NCT00648986|Drug|Tazorac|All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.
16299645|NCT00648973|Drug|Diphenhydramine 50 mg|"Three times daily: two diphenhydramine 25 mg capsules
~Twice daily: one pseudoephedrine-matching placebo tablet"
16299646|NCT00648973|Drug|Diphenhydramine 25 mg|"Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule
~Twice daily: one pseudoephedrine-matching placebo tablet"
16299823|NCT00647777|Drug|Olanzapine Tablets 5 mg|5mg, single dose fed
16299649|NCT00648960|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral dose
16299650|NCT00648947|Drug|Clopidogrel Bisulfate Tablets 75 mg|75mg, single dose fasting
16299651|NCT00648947|Drug|Plavix® Tablets 75 mg|75mg, single dose fasting
16299652|NCT00648934|Drug|Topiramate Sprinkle Capsules 25 mg|25mg, single dose fed
16299653|NCT00648934|Drug|Topamax® Sprinkle Capsules 25 mg|25mg, single dose fed
16299654|NCT00648921|Drug|Olanzapine Tablets 5 mg|5mg, single dose fasting
16299655|NCT00648921|Drug|Zyprexa® Tablets 5 mg|5mg, single dose fasting
16299656|NCT00648908|Drug|Fampridine-SR|Tablets, 10 mg, BID
16299657|NCT00648895|Drug|Nebivolol|nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
16299658|NCT00648895|Drug|Metoprolol ER (TM)|Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
16299659|NCT00648882|Drug|LEVOTHYROXINE SODIUM TABLETS,|2x300mcg, single dose fasting
16299660|NCT00648882|Drug|SYNTHROID® 300 mcg Tablets|2x300mcg, single dose fasting
16299661|NCT00648869|Drug|metformin tablet, metformin gum|500 mg, 250 mg
16299662|NCT00648856|Drug|Sertraline Hydrochloride Tablets 100 mg|100mg, single dose fed
16299663|NCT00648856|Drug|Zoloft® Tablets 100 mg|100mg, single dose fed
16299664|NCT00648843|Drug|Oxybutynin Chloride Extended-release Tablets 5 mg|4x5mg, single dose fed
16299665|NCT00648843|Drug|Ditropan XL® Tablets 5 mg|4x5mg, single dose fed
16299666|NCT00648830|Procedure|Clarithromycin|Single-dose of Clarithromycin 250 mg oral immediate-release tablets
16299667|NCT00648830|Drug|Clarithromycin|single-dose 250 mg immediate-release oral tablets
16299668|NCT00648817|Drug|Tenofovir Disoproxil Fumarate|Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil)
16299669|NCT00648817|Drug|Tenofovir DF placebo|Tenofovir DF placebo tablet QD
16299670|NCT00648804|Drug|Ondansetron Orally Disintegrating Tablets 8 mg|8mg, single dose fed
16299671|NCT00648804|Drug|Zofran ODT® Tablets 8 mg|8mg, single dose fed
16299672|NCT00648791|Drug|Finasteride Tablets 5 mg|5mg, single dose fasting
16299673|NCT00648791|Drug|Proscar Tablets 5 mg|5mg, single dose fasting
16299674|NCT00648778|Drug|Loxapine Succinate Capsules 25 mg|25mg, single dose fasting
16299675|NCT00648778|Drug|Loxitane® Capsules 25 mg|25mg, single dose fasting
16299676|NCT00648765|Drug|Anagrelide Hydrochloride Capsules 1 mg|1mg, single dose fed
16299677|NCT00648765|Drug|Agrylin® Capsules 1 mg|1mg, single dose fed
16299678|NCT00648739|Drug|Samalizumab|Samalizumab is a humanized anti-CD200 monoclonal antibody.
16299679|NCT00648726|Drug|cefuroxime plus erythromycin|intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens
16299680|NCT00648726|Drug|azithromycin (Zithromax)|intravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days
16299681|NCT00648726|Drug|cefuroxime|intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days
16299682|NCT00648713|Drug|Terbinafine Hydrochloride Tablets 250 mg|250mg, single dose fed
16299683|NCT00648713|Drug|Lamisil® Tablets 250 mg|250mg, single dose fed
16299684|NCT00648700|Drug|Levothyroxine Sodium Tablets 300 μg|2x300mcg, single dose fasting
16299685|NCT00648700|Drug|Levothroid® Tablets 300 μg|2x300mcg, single dose fasting
16299686|NCT00648687|Behavioral|suck 12.5% dextrose in water 5 minutes before the procedure|Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
16299687|NCT00648674|Device|Apligraf|Applied at Day 0, possible re-application at Week 6
16299688|NCT00648661|Drug|Escitalopram Oxalate Tablets 20 mg|20mg, single dose fed
16299689|NCT00648661|Drug|Lexapro® Tablets 20 mg|20mg, single dose fed
16299690|NCT00648648|Drug|MK-1775|MK-1775 administered as an oral formulation as either monotherapy or in combination with either gemcitabine, cisplatin, or carboplatin.
16299691|NCT00648648|Drug|gemcitabine|Gemcitabine administered at 1000 mg/m^2 by IV infusion in a 28-day cycle.
16299692|NCT00648648|Drug|cisplatin|Cisplatin administered at 75 mg/m^2 by IV infusion in a 21-day cycle.
16299693|NCT00648648|Drug|carboplatin|Carboplatin administered at AUC/time curve of 5 mg/min/mL (AUC5) by IV infusion in a 21-day cycle.
16299695|NCT00648622|Drug|Carvedilol Tablets 12.5 mg|12.5mg, single dose fed
16299696|NCT00648622|Drug|Coreg® Tablets 12.5 mg|12.5mg, single dose fed
16299697|NCT00648609|Other|Palliative home care in advanced COPD|Interdisciplinary palliative care team on community based self care management of advanced COPD.
16299698|NCT00648609|Other|Standard of care|Usual care for COPD patients
16299699|NCT00648596|Drug|sildenafil|sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
16299700|NCT00648596|Drug|placebo|placebo tablet by mouth 1 hour before sexual activity for 12 weeks
16299701|NCT00648583|Drug|Ondansetron Tablets 24 mg|24mg, single dose fed
16299702|NCT00648583|Drug|Zofran® Tablets 24 mg|24mg, single dose fed
16299703|NCT00648570|Drug|Escitalopram Oxalate Tablets 20 mg|20mg, single dose fasting
16299704|NCT00648570|Drug|Lexapro® Tablets (20 mg|20mg, single dose fasting
16299705|NCT00648557|Drug|Levothyroxine Sodium Tablets 200 mg|3x200mcg, single dose fasting
16299706|NCT00648557|Drug|Synthroid Tablets 200 mg|3x200mcg, single dose fasting
16299707|NCT00648544|Drug|Pravastatin|Single-dose 80 mg oral immediate-release tablet
16299708|NCT00648544|Drug|Pravastatin|Single-dose 80 mg oral immediate-release tablets
16299709|NCT00648531|Drug|Balsalazide Disodium Capsules 750 mg|3x750mg, single dose fasting
16299710|NCT00648531|Drug|Colazal® Capsules 750 mg|3x750mg, single dose fasting
16299711|NCT00648518|Drug|Metformin Hydrochloride ER Tablets 750 mg|750mg, single dose fasting
16299712|NCT00648518|Drug|Glucophage® XR Tablets 750 mg|750mg, single dose fasting
16299824|NCT00647777|Drug|Zyprexa® Tablets 5 mg|5mg, single dose fed
16299713|NCT00648505|Drug|Glipizide and Metformin HCl Tablets 5 mg/500 mg|5/500mg, single dose fed
16299714|NCT00648505|Drug|Metaglip® Tablets 5 mg/500 mg|5/500mg, single dose fed
16299715|NCT00648492|Drug|Metformin Hydrochloride ER Tablets 500 mg|500mg, single dose fed
16299716|NCT00648492|Drug|Glucophage® XR 500 mg|500mg, single dose fed
16299717|NCT00648479|Device|The Guiding Star|
16299718|NCT00648479|Device|fluoroscopy (OEC 9800 - General Electric)|
16299719|NCT00648466|Drug|Sumatriptan Succinate Tablets 100 mg|100mg, single dose fasting
16299720|NCT00648466|Drug|Imitrex® Tablets 100 mg|100mg, single dose fasting
16299721|NCT00648453|Drug|Clopidogrel (Plavix)|
16299722|NCT00648440|Drug|Midodrine HCl Tablets 5 mg|5mg, single dose fed
16299723|NCT00648440|Drug|ProAmatine® Tablets 5 mg|5mg, single dose fed
16299724|NCT00648427|Drug|Paroxetine Hydrochloride Controlled-Release Tablets 25 mg|25mg, single dose fasting
16299725|NCT00648427|Drug|Paxil CR™ Tablets 25 mg|25mg, single dose fasting
16299726|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1|blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow, while samples collected
16299727|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2|tourniquet applied just below patch application site and above blood draw site, while samples collected
16299728|NCT00648414|Drug|Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3|tourniquet applied just above patch application site, while samples collected
16299729|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 1|blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow
16299730|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 2|tourniquet applied just below patch application site and above blood draw site, while samples collected
16299731|NCT00648414|Drug|Duragesic 25 mcg/h + Clinical Procedure 3|tourniquet applied just above patch application site, while samples collected
16299732|NCT00648401|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose fed
16299733|NCT00648401|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose fed
16299734|NCT00648388|Drug|Cilostazol Tablets 100 mg|100mg, single dose fasting
16299735|NCT00648388|Drug|Pletal® Tablets 100 mg|100 single dose fasting
16299736|NCT00648375|Drug|Propanolol|Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
16299737|NCT00648375|Drug|Placebo|Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
16299738|NCT00648375|Behavioral|Cognitive therapy workbook|Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
16299739|NCT00648362|Drug|Glimepiride Tablets 1 mg|1mg, single dose fasting
16299740|NCT00648362|Drug|Amaryl® Tablets 1 mg|1mg, single dose fasting
16299741|NCT00648349|Drug|Rabeprazole Sodium Delayed-Release Tablets 20 mg|20mg, single dose fasting
16299742|NCT00648349|Drug|Aciphex® Delayed-Release Tablets 20 mg|20mg, single dose fasting
16299743|NCT00648336|Drug|Mercaptopurine 50 mg|50mg, single dose fasting
16299744|NCT00648336|Drug|Purinethol® Tablets 50 mg|50mg, single dose fasting
16299745|NCT00648323|Drug|Doxazosin mysylate GITS|Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
16299746|NCT00648310|Drug|Tolterodine 4 mg|
16299747|NCT00648310|Drug|arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks|
16299748|NCT00648297|Drug|Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg|80/5mg, single dose fed
16299749|NCT00648297|Drug|Corzide® Tablets 80 mg/5 mg|80/5mg, single dose fed
16299750|NCT00648271|Drug|Metoprolol Tartrate Tablets 25 mg|2x50mg, single dose fed
16299751|NCT00648271|Drug|Lopressor® Tablets 50 mg|1x50mg, single dose fed
16299752|NCT00648258|Drug|valdecoxib|valdecoxib 10 mg tablet by mouth once daily for 6 weeks
16299753|NCT00648258|Drug|naproxen|naproxen 500 mg capsule by mouth twice daily for 6 weeks
16299754|NCT00648245|Drug|BIO-11006 Inhalation Solution|75 mg of BIO-11006 administered once per day for 21 days by nebulizer
16299755|NCT00648245|Drug|BIO-11006 Inhalation Solution|150 mg of BIO-11006 administered once per day for 21 days by nebulizer
16299756|NCT00648245|Drug|BIO-11006 Inhalation Solution|75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
16299757|NCT00648245|Drug|Placebo|Placebo given once daily for 21 days by nebulizer
16299758|NCT00648245|Drug|BIO-11006|125 mg BIO-11006 given twice per day for 21 days by nebulizer
16299759|NCT00648232|Behavioral|Voluntary brief HIV counseling and testing|Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
16299760|NCT00648232|Behavioral|Voluntary longer, more detailed HIV counseling and testing|Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
16299761|NCT00648232|Behavioral|Enhanced linkage to care|Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
16299762|NCT00648232|Behavioral|Routine referral to care|Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
16299763|NCT00648219|Drug|Olmesartan Medoxomil Tablets 40 mg|40mg, single dose fed
16299764|NCT00648219|Drug|Benicar® Tablets 40 mg|40mg, single dose fed
16299765|NCT00648193|Drug|Paroxetine hydrochloride 40 mg tablet|40mg, single dose fasting
16299766|NCT00648193|Drug|Paxil® 40 mg Table|40mg, single dose fasting
16299767|NCT00648180|Drug|Doxycycline Monohydrate Tablets 100 mg|100mg, single dose fed
16299768|NCT00648180|Drug|Adoxa Tablets 100 mg|100mg, single dose fed
16299769|NCT00648167|Drug|ferric citrate|ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.
16299770|NCT00648154|Drug|Letrozole Tablets 2.5 mg|2.5mg, single dose fed
16299771|NCT00648154|Drug|Femara® Tablets 2.5 mg|2.5mg, single dose fed
16299772|NCT00648141|Drug|Celecoxib|200 mg oral capsule once daily for 12 weeks
16299773|NCT00648141|Drug|Celecoxib|200 mg oral capsule twice daily for 12 weeks
16299774|NCT00648141|Drug|Diclofenac|75 mg oral capsule twice daily for 12 weeks
16299775|NCT00648128|Drug|Clarithromycin|Single-dose 500 mg immediate-release oral tablet
16299776|NCT00648128|Drug|Clarithromycin|single-dose 500 mg immediate-release oral dose'
16299777|NCT00648115|Other|Basic Vocational Services|Vocational services
16299778|NCT00648115|Other|Self-Study|Veteran receives self-study resources
16299779|NCT00648115|Other|Group Program|Veteran participates in group vocational program
16299780|NCT00648102|Biological|CDX-1307|
16299781|NCT00648089|Drug|EPO|Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
16299782|NCT00648076|Drug|Divalproex Sodium Extended-Release Tablets 500 mg|500mg, single dose fed
16299783|NCT00648076|Drug|Depakote ER® Tablets 500 mg|500mg, single dose fed
16299784|NCT00648063|Drug|Letrozole Tablets 2.5 mg|2.5mg, single dose fasting
16299785|NCT00648063|Drug|Femara® Tablets 2.5 mg|2.5mg, single dose fasting
16299786|NCT00648050|Drug|Verapamil Hydrochloride Extended-Release Capsules, 300 mg|300mg, single dose fasting
16299787|NCT00648050|Drug|Verelan® PM Extended-Release Capsules, 300 mg|300mg, single dose fasting
16299788|NCT00648037|Drug|Rituximab|Rituximab 375 mg/m^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is > 200 cells/ul or a maximum of 6 doses have been given.
16299789|NCT00648024|Drug|Anagrelide Hydrochloride Capsules 1 mg|1mg, single dose fasting
16299790|NCT00648024|Drug|Agrylin® Capsules 1 mg|1mg, single dose fasting
16299791|NCT00648011|Drug|Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg|20/25mg, single dose fed
16299792|NCT00648011|Drug|Accuretic™ Tablets 20 mg/25 mg|20/25mg, single dose fed
16299793|NCT00647998|Drug|Darbepoetin alfa|Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery
16299794|NCT00647998|Other|Standard care|
16299795|NCT00647985|Drug|Fexofenadine Tablets 180 mg|180mg, single dose fed
16299796|NCT00647985|Drug|Allegra® Tablets 180 mg|180mg, single dose fed
16299797|NCT00647972|Drug|Olanzapine Tablets 20 mg|20mg, single dose fasting
16299798|NCT00647972|Drug|Zyprexa® Tablets 20 mg|20mg, single dose fasting
16299799|NCT00647959|Drug|Doxycycline Tablets, 150mg|150mg, single dose fasting
16299800|NCT00647959|Drug|Adoxa Tablets 150 mg|150mg, single dose fasting
16299801|NCT00647946|Drug|tenofovir DF|tenofovir DF 300mg once daily along with the other antiviral drugs
16299802|NCT00647946|Drug|abacavir 300mg twice daily|abacavir 300mg twice daily along with the other antiviral drugs
16299803|NCT00647933|Drug|Org 36286|Subcutaneous Org 36286
16299804|NCT00647933|Drug|Lyndiol®|Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
16299805|NCT00647920|Biological|adalimumab|40 mg adalimumab sc, every other week
16299806|NCT00647920|Biological|placebo|placebo sc, every other week
16299807|NCT00647907|Drug|Voriconazole|Oral or intravenous voriconazole. Oral tablets 400 mg twice daily loading dose on first day, followed by 200 mg twice daily taken at least 1 hour before or after a meal. Oral doses could be increased to a maximum of 300 mg twice daily if there was no clinical improvement after at least 3 days of treatment, no serious adverse events were reported, and clinical chemistry parameters were within the acceptable range for study entry. Intravenous treatment was initiated with a loading dose of 6 mg/kg twice daily for the first day followed by 4 mg/kg twice daily for at least 3 days (maximum infusion rate of 3 mg/kg/hr if administered by peripheral intravenous line). An intravenous loading dose was not required in patients who were restarted after oral treatment. Total duration of therapy (intravenous and oral) was 12 weeks.
16299808|NCT00647894|Drug|Alprazolam Extended-Release Tablets 1 mg|
16299809|NCT00647894|Drug|Xanax XR Tablets 1 mg|
16299810|NCT00647881|Drug|Paroxetine Hydrochloride Controlled-Release Tablets 25 mg|25mg, single dose fed
16299811|NCT00647881|Drug|Paxil CR™ Tablets 25 mg|25mg, single dose fed
16299812|NCT00647868|Drug|testosterone|Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
16299813|NCT00647855|Drug|Levothyroxine Sodium Tablets 300 μg|2x300mcg, single dose fasting
16299814|NCT00647855|Drug|Synthroid® Tablets 300 μg|2x300mcg, single dose fasting
16299815|NCT00647842|Drug|Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay|single application
16299816|NCT00647842|Drug|Fentanyl Transdermal System 25 mcg/h|single application
16299817|NCT00647829|Drug|valdecoxib|valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
16299818|NCT00647829|Drug|valdecoxib|valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
16299819|NCT00647829|Drug|placebo|placebo tablet by mouth for 2 doses over a 24-hour period
16299820|NCT00647816|Drug|Propranolol Hydrochloride Extended-Release Capsules 160 mg|160mg, single dose fasting
16299821|NCT00647816|Drug|Inderal® LA Capsules 160 mg|160mg, single dose fasting
16299822|NCT00647790|Procedure|PET scan with injection of 5-8 mCi of 18FES|Following injection of the tracer 18FES, dynamic images will be obtained for 30 minutes over the chest area to include cardiac region and breasts. Following the first dynamic imaging for 30 minutes, whole body images (base of skull to pelvis) will be obtained at 5 minute/bed position. An additional, longer scan after 60 minutes will be obtained for the chest (1-2-FOV for 15 minutes each). Total time from injection to completion of imaging will be about 90 minutes.
16299825|NCT00647764|Drug|SNX-5422 Mesylate Hsp90 inhibitor|dose escalated, tablets twice a week; undetermined duration until disease progression
16299826|NCT00647751|Drug|Lamotrigine Tablets 25 mg|2x25mg, single dose fed
16299827|NCT00647751|Drug|Lamictal® Tablets 25 mg|2x25mg, single dose fed
16299828|NCT00647738|Drug|Baclofen|Single-dose 20 mg immediate-release oral tablets
16299829|NCT00647738|Drug|Baclofen|Single-dose 20 mg immediate-release oral tablet
16299830|NCT00647725|Procedure|Active phrase epidural analgesia|Continuous epidural analgesia with sufentanil plus ropivacaine
16299831|NCT00647725|Procedure|Latent phrase epidural analgesia|Continuous epidural analgesia with sufentanil plus ropivacaine
16299832|NCT00647712|Drug|Divalproex Sodium Extended-Release Tablets 500 mg|500mg, single dose fasting
16299833|NCT00647712|Drug|Depakote ER® Tablets 500 mg|500mg, single dose fasting
16299834|NCT00647699|Drug|riboflavin ophthalmic solution|riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
16299835|NCT00647699|Device|UVA Irradiation|UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
16299836|NCT00647686|Drug|Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay|single application
16299837|NCT00647686|Drug|Fentanyl Transdermal System 25 mcg/h|single application
16299838|NCT00647673|Drug|Verapamil HCL Extended-Release Capsules 300 mg|300mg, single dose fasting
16299839|NCT00647673|Drug|Verelan® PM Extended-Release Capsules 300 mg|300mg, single dose fasting
16299840|NCT00647660|Drug|Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg|80/5mg, single dose fasting
16299841|NCT00647660|Drug|Corzide® Tablets 80 mg/5 mg|80/5mg, single dose fasting
16299842|NCT00647647|Drug|Terbinafine Hydrochloride Tablets 250 mg|250mg, single dose fasting
16299843|NCT00647647|Drug|Lamisil® Tablets 250 mg|250mg, single dose fasting
16299844|NCT00647634|Drug|Alprazolam Extended-Release Tablets 3 mg|3mg, single dose fasting
16299845|NCT00647634|Drug|Xanax XR® Tablets (3 mg|3mg, single dose fasting
16299846|NCT00647621|Drug|Extended Phenytoin Sodium Capsules 100 mg|3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
16299847|NCT00647621|Drug|Dilantin® Kapseals® 100 mg|3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
16299848|NCT00647608|Drug|Propranolol Hydrochloride Extended-Release Capsules 160 mg|160mg, single dose fed
16299849|NCT00647608|Drug|Inderal® LA Capsules 160 mg|160mg, single dose fed
16299850|NCT00647595|Behavioral|Experimental group|Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.
16299851|NCT00647582|Procedure|adjuvant therapy|
16299852|NCT00647582|Procedure|therapeutic conventional surgery|
16299853|NCT00647582|Radiation|intraoperative radiation therapy|
16299854|NCT00647582|Radiation|radiation therapy|
16299855|NCT00647569|Procedure|Mesh repair|A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.
16299856|NCT00647569|Procedure|Conventional facial closure|The abdominal facia is closed with with continuous running suture
16299857|NCT00647556|Drug|adapalene gel, 0.3%|applied topically once daily in the evening
16299858|NCT00647556|Drug|tretinoin 0.05% emollient cream|applied topically once daily in the evening
16299859|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
16299860|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
16299861|NCT00647543|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
16299862|NCT00647530|Biological|panitumumab|
16299863|NCT00647530|Drug|capecitabine|
16299864|NCT00647530|Drug|fluorouracil|
16299865|NCT00647530|Drug|oxaliplatin|
16299866|NCT00647517|Drug|Ultracet|"For the treatment arm: Tramadol 37.5 mg/APAP 325 mg combination tablets (Ultracet®) one tablet twice a day plus aceclofenac tablet per oral 100 mg twice a day.
~For the control group: Placebo plus aceclofenac tablet per oral 100 mg twice a day."
16299867|NCT00647491|Biological|adalimumab|20 mg sc eow
16299868|NCT00647491|Biological|adalimumab|40 mg sc eow
16299869|NCT00647491|Biological|adalimumab|80 mg sc eow
16299870|NCT00647491|Biological|placebo|placebo sc eow
16299871|NCT00647465|Drug|vaccine|IFNalpha 2b
16299872|NCT00647465|Drug|Placebo|Placebo
16299873|NCT00647452|Behavioral|Exercise|Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
16299874|NCT00647426|Drug|Sorafenib + Docetaxel/Carboplatin|400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
16299875|NCT00647413|Behavioral|bio-chemical feedback and expert system intervention ETS|"Urinary cotinien will be measured using urine collected from the infants diaper. It will be analysed and the result will be explained to the participant in a written letter approximately 2 weeks after the intervention.
~The intervention will also be a counselling session about the consequences of ETS to the infant. The counselling will be guided by the principles of motivational intervieweing and an expert system letter tailored to the data assessed will be send to the participants"
16299876|NCT00647400|Biological|adalimumab|Adalimumab 40 mg every other week, subcutaneous
16299877|NCT00647400|Biological|adalimumab|Adalimumab 80 mg every other week, subcutaneous
16299878|NCT00647387|Device|Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)|Device
16299879|NCT00647374|Other|this is an observational study|
16299880|NCT00647361|Device|Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).|Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
16299881|NCT00647348|Drug|Simvastatin|80mg simvastatin oral once daily for 24 months
16299882|NCT00647348|Drug|Placebo|Oral placebo tablet once daily for 24 months
16299883|NCT00647322|Other|Reduction of anti-epileptic medications|Reduction in anti-epileptic medications
16299884|NCT00647322|Procedure|No drug change|No change in anti-epileptic treatment
16299885|NCT00647296|Drug|Placebo|Placebo: 2 tablets taken orally twice daily
16299886|NCT00647296|Drug|Dexpramipexole 50 mg/day|Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily
16299887|NCT00647296|Drug|Dexpramipexole 150 mg/day|Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily
16299888|NCT00647296|Drug|Dexpramipexole 300 mg/day|Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
16299889|NCT00647283|Procedure|Gradual immunosuppression drug withdrawal|After the obtention of biological samples (peripheral blood, liver tissue), enrolled patients undergo gradual weaning of all immunosuppressive therapy over a 6-9 month period under close medical supervision.
16299890|NCT00647270|Drug|adalimumab|Pre-filled syringe. See arm for more detail
16299891|NCT00647270|Drug|Placebo|Pre-filled syringe. See arm for more detail
16299892|NCT00647270|Drug|adalimumab|Pre-filled syringe. See arm for more detail
16299893|NCT00647257|Drug|Losartan|Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Losartan 100mg add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
16299894|NCT00647257|Drug|Placebo|Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Placebo add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
16299895|NCT00647244|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil 245 mg oral tablet once daily
16299896|NCT00647244|Drug|Abacavir|Abacavir 300 mg oral tablet twice daily
16299897|NCT00647231|Drug|HKT-500 Topical Patch|Treatment with Ketoprofen Topical Patch
16299898|NCT00647231|Other|Placebo Patch|Treatment with placebo patch
16299899|NCT00647218|Drug|Post-operative adjuvant therapy|Adriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles.
16299900|NCT00647218|Drug|neoadjuvant therapy|Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles
16299901|NCT00647218|Procedure|therapeutic surgical procedure|Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.
16299902|NCT00647218|Radiation|Radiation therapy with concurrent Paclitaxel|Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week
16299903|NCT00647218|Drug|Hormonal Therapy|After completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive.
16299904|NCT00647205|Device|QuantiFERON TB Gold In-Tube|
16299905|NCT00647205|Device|T-SPOT.TB®|
16299906|NCT00647192|Drug|Eplerenone|50 mg per day
16299907|NCT00647192|Drug|Placebo|50 mg per day
16299908|NCT00647179|Procedure|Transsphenoidal adenomectomy|Surgery
16299909|NCT00647166|Drug|corticosteroid and azathioprine|"Corticosteroid 1 mg/kg/day with a conventional decrease dose
~Azathioprine : 2 mg/kg/day during one year in 2 to 3 times a day by oral route"
16299910|NCT00647166|Drug|corticosteroid and placebo|"Corticosteroid 1 mg/kg/day with a conventional decrease dose
~Placebo : 2 mg/kg/day during one year in 2 to 3 times a day by oral route"
16299911|NCT00647153|Other|pharmacological study|Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.
16299912|NCT00647153|Procedure|single photon emission computed tomography|One day post infusion
16299913|NCT00647153|Radiation|iodine I 123 anti-CEA recombinant diabody T84.66|10mCi/mg
16299914|NCT00647140|Other|18F-L-DOPA PET|PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA
16299915|NCT00647127|Drug|Buprenorphine|Buprenorphine: 20microg/h
16299916|NCT00647127|Drug|Fentanyl|Fentanyl: 25microg/h
16299917|NCT00647127|Drug|Placebo|Placebo: '5microg/h' (not active drug, it is just called '5microg/h')
16299918|NCT00647114|Biological|V930|V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.
16299919|NCT00647114|Biological|V932|V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).
16299920|NCT00647101|Drug|Latanoprost|Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months
16299921|NCT00647075|Dietary Supplement|Yunzhi extract|3.5 g/day
16299922|NCT00647075|Dietary Supplement|Placebo|Placebo (starch)
16299923|NCT00647049|Drug|methotrexate|8000mg/m2 i.v., max. 2 cycles
16299924|NCT00647049|Drug|Rituximab|375mg/m2, max. 8 times
16299925|NCT00647049|Drug|Cytarabine|3000mg/m2 die i.v., 2 days (max. 2 cycles)
16299926|NCT00647049|Drug|Thiotepa|40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
16299927|NCT00647049|Drug|Carmustin|400mg/m2 i.v. for 1 day
16299928|NCT00647036|Dietary Supplement|Isonitrogenous Vaminolact|Isonitrogenous Vaminolact
16299929|NCT00647036|Drug|Dipeptiven (L-glutamine- Lalanine)|0.6g/kg/day
16299930|NCT00647023|Drug|metformin|1000 mg metformin x 2 daily during 8 months
16299931|NCT00646984|Drug|Standard continuous antiretroviral therapy|
16299932|NCT00646984|Drug|CD-4 guided therapy interruption|Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
16299933|NCT00646984|Drug|Viral load driven treatment interruption|Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml
16299934|NCT00646971|Device|CPAP device|for 4 weeks
16299937|NCT00646958|Drug|Radezolid|450mg PO BID
16299938|NCT00646958|Drug|Linezolid|600mg PO BID
16299939|NCT00646945|Drug|50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)|gas flow between 4 to 15 L/min
16299940|NCT00646945|Drug|50% Oxygen/50% Nitrogen premix|gas flow between 4 to 15 L/min
16299941|NCT00646932|Drug|paricalcitol|paricalcitol 0.04 mcg/kg three times a week
16299942|NCT00646932|Drug|paricalcitol|paricalcitol 0.08 mcg/kg three times a week
16299943|NCT00646932|Drug|paricalcitol|paricalcitol 0.16 mcg/kg three times a week
16299944|NCT00646932|Drug|paricalcitol|paricalcitol 0.24 mcg/kg three times a week
16299945|NCT00646919|Procedure|Nose swab|
16299946|NCT00646906|Drug|Aspirin First|Crossover period Aspirin First: Subjects will receive 81 mg aspirin at approximately 8 am followed by acetaminophen at approximately 10 am.
16299947|NCT00646906|Drug|Aspirin Last|Crossover period Aspirin Last: Subjects will receive acetaminophen at approximately 8 am followed by 81 mg aspirin at approximately 10 am.
16299948|NCT00646906|Drug|Acetaminophen 1000 mg/d|Subjects will receive a daily oral dose of 1000 mg acetaminophen for six days each administered at 8 AM.
16299949|NCT00646906|Drug|Acetaminophen 4000 mg/d|Crossover period Acetaminophen 4000 mg/d: Acetaminophen (1000 mg p.o.) orally at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.
16299950|NCT00646906|Drug|Ibuprofen 800 mg/d|Crossover period Ibuprofen 800 mg/d: Ibuprofen (200 mg) orally at at 8 AM, 2 PM, 8 PM and 2 AM for 3 days. The last dose will be administered on day four at 8 AM.
16299951|NCT00646893|Procedure|Preimplantation Genetic Diagnosis (PGD)|"one-cell embryo biopsy on day 3 of development. The cell will be analyzed by FISH using probes for X,Y,13,15,16,17,18,21,22 chromosomes. Cells with dubious results will be reanalyzed by no result rescue (Colls et al. 2007)"
16299952|NCT00646880|Drug|propiverine|Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.
16299953|NCT00646880|Drug|tolterodine PR|Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.
16299954|NCT00646867|Device|Tetrix|Twice daily topical application
16299955|NCT00646867|Device|Placebo|Twice daily topical application
16299956|NCT00646854|Drug|CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab|Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4
16299957|NCT00646854|Drug|CHOP14 chemotherapy (see specification under Arm B) plus G-CSF|6 cycles of CHOP every 2 weeks
16299958|NCT00646841|Drug|Doxazosin gastrointestinal therapeutic system (GITS)|4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).
16299959|NCT00646815|Drug|growth hormone (genotropin)|Dosage regulation will follow the local recommendations of GHD treatment
16299960|NCT00646802|Drug|Progesterone|1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
16299961|NCT00646802|Drug|Placebo|1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
16299962|NCT00646789|Drug|Comparator: MK0633|patients will receive single 50mg oral dose with follow-up observation for 5 weeks.
16299963|NCT00646776|Drug|Rifabutin|Capsule, Oral, 150 mg, once daily, 11 Days
16299964|NCT00646776|Drug|Rifabutin + Atazanavir + Ritonavir|"Capsules, Oral, 18 Days
~Rifabutin (150 mg, 2x/wk)
~Atazanavir (300 mg, once daily)
~Ritonavir (100 mg, once daily)"
16299965|NCT00646763|Drug|G-CSF, GM-CSF administered at extremities|Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.
16299966|NCT00646763|Drug|G-CSF and GMCSF administered at abdomen|Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.
16299967|NCT00646750|Drug|Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)|"Day -21: rituximab. 250 mg/m2 iv
~Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi).
~Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1."
16299968|NCT00646737|Drug|Mycophenolate sodium|Mycophenolate sodium
16299969|NCT00646724|Biological|cotransplantation of islet and mesenchymal stem cell|islet of allograft and MSCs of autograft
16299970|NCT00646711|Drug|Depakote Delayed-Release/Depakote Sprinkle|Administered according to the subject's usual regimen.
16299971|NCT00646711|Drug|Depakote ER|Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
16299972|NCT00646685|Procedure|surgical technique: duct-to-duct biliary reconstruction|surgical reconstruction
16299973|NCT00646685|Procedure|surgical technique: roux-en-y biliary reconstruction|surgical reconstruction
16299974|NCT00646659|Biological|cetuximab|
16299975|NCT00646659|Drug|carboplatin|
16299976|NCT00646659|Drug|cisplatin|
16299977|NCT00646659|Drug|docetaxel|
16299978|NCT00646659|Drug|fluorouracil|
16299979|NCT00646659|Genetic|fluorescence in situ hybridization|
16299980|NCT00646659|Genetic|molecular genetic technique|
16299981|NCT00646659|Genetic|reverse transcriptase-polymerase chain reaction|
16299982|NCT00646659|Other|immunoenzyme technique|
16299983|NCT00646659|Other|immunohistochemistry staining method|
16299984|NCT00646659|Other|laboratory biomarker analysis|
16299985|NCT00646659|Procedure|biopsy|
16299986|NCT00646659|Radiation|3-dimensional conformal radiation therapy|
16299987|NCT00646659|Radiation|intensity-modulated radiation therapy|
16299988|NCT00646646|Drug|propofol|sedative
16299989|NCT00646646|Drug|dexmedetomidine|Sedative
16299990|NCT00646646|Drug|Midazolam|sedative
16299991|NCT00646646|Drug|saline placebo|saline placebo
16299992|NCT00646633|Procedure|Acupuncture and patient education|Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
16299993|NCT00646620|Drug|budesonide/formoterol (Symbicort)|
16299994|NCT00646620|Drug|fluticasone/salmeterol (Advair Diskus)|
16299995|NCT00646620|Drug|albuterol (Ventolin)|
16299996|NCT00646607|Drug|FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)|To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
16299997|NCT00646607|Drug|FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)|standard treatment
16299998|NCT00646594|Drug|budesonide/formoterol (Symbicort)|
16299999|NCT00646594|Drug|fluticasone/salmeterol (Advair)|
16300000|NCT00646581|Drug|Placebo|Placebo
16300001|NCT00646581|Drug|Insulin (Humulin)|40 IU Intranasal Insulin will be administered once
16300002|NCT00646568|Drug|s.c. human chorionic gonadotropin (Pregnyl)|S.C. Pregnyl 10000 IU once
16300003|NCT00646542|Drug|Vildagliptin|
16300004|NCT00646542|Drug|Placebo|
16300005|NCT00646529|Drug|budesonide/formoterol (Symbicort)|
16300006|NCT00646529|Drug|budesonide (Pulmicort)|
16300007|NCT00646516|Drug|budesonide/formoterol (Symbicort)|
16300008|NCT00646503|Drug|Telbivudine|600 mg/day, oral telbivudine for 52 weeks
16300009|NCT00646477|Device|titration night|"Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:
~in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.
~in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events."
16300010|NCT00646451|Drug|pregabalin (Lyrica)|75 mg bid to 300 mg bid based on per subject tolerability
16300011|NCT00646451|Drug|placebo|up to 4 capsules bid as tolerated
16300012|NCT00646438|Drug|Strict Glycemic Control for one year post-op CABG|"The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips.
~Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed.
~For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control."
16300013|NCT00646425|Drug|Basiliximab|40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses
16300014|NCT00646425|Drug|Placebo|Placebo to match basiliximab
16300015|NCT00646412|Device|A-Part® Gel|10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion
16300016|NCT00646399|Drug|Placebo|Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23.
16300017|NCT00646399|Drug|Pagibaximab 50 mg/mL|Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23
16300018|NCT00646386|Drug|adalimumab|40 mg eow Week 0 - Week 24
16300019|NCT00646386|Drug|placebo for adalimumab|40 mg eow Week 0 - Week 24
16300020|NCT00646373|Other|Low Prime|The CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml.
16300021|NCT00646360|Dietary Supplement|DHA|400 mg/d of docosahexanoic acid (DHA) during pregnancy
16300022|NCT00646360|Dietary Supplement|Placebo|2 tablets daily during pregnancy
16300023|NCT00646347|Other|Conventional upper limb stroke rehabilitation|"Patient will be given a ten weeks conventional upper limb therapy. 3 sessions will be provided weekly in the first 4 weeks and 2 therapy sessions will be provided weekly in the subsequent 6 weeks. Patients will receive half an hour of conventional therapy in each session.
~Patient will be taught to carry out two and half hours conventional self practice exercise daily for a period of ten weeks."
16300024|NCT00646347|Device|Neuro Hand Orthosis Program (NHOP)|"The NHO is based on a design of dynamic hand orthosis for orthopaedic patients after hand surgery. We use it to support CVA patient's wrist and finger to perform grasping to transport an object (ball) from place to place to achieve the follows;
~NHO can assist stroke patients to experience successful hand grasping with an object and produce voluntary movement from their paralytic arm. This successful experience will positively reinforce the patient to continue to use their paralytic arm and change the patient's behavior and perception in the arm usage.
~The NHO Program is able to engage patients to perform their exercises and activities by themselves independently with the effect of intensive therapy.
~The intervention (NHOP) group will receive same treatment intensity as the control group but with a Neuro Hand Orthosis."
16300025|NCT00646334|Device|Mesh Implantation|An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.
16300078|NCT00645905|Drug|placebo for adalimumab|OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose
16300079|NCT00645892|Drug|adalimumab|OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24
16300026|NCT00646334|Device|Mesh Implantation|Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips.
16300027|NCT00646321|Drug|budesonide/formoterol (Symbicort)|
16300028|NCT00646321|Drug|budesonide|
16300029|NCT00646295|Device|To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes|Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer
16300030|NCT00646282|Drug|doxercalciferol|The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
16300031|NCT00646269|Behavioral|Standard intervention protocol|The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
16300032|NCT00646269|Behavioral|Standard intervention protocol + Cognitive training therapy|"Cognitive training therapy is provided in small groups of 5 to 8 patients. It consists in classroom type sessions designed to provide general cognitive stimulation. A set of standard cognitive exercises (involving memory, attention, or problem-solving…) related to activities of daily living is realized at each session."
16300033|NCT00646269|Behavioral|Standard intervention protocol + Reminiscence therapy|"Reminiscence therapy is provided in small groups of 5 to 8 patients. This therapy involves the discussion of past activities, events and experiences enhanced by aids such as photographs, familiar items, songs, or personal recordings. A particular topic of life (i.e. a wedding) is discussed at each session."
16300034|NCT00646269|Behavioral|"Standard intervention protocol + Made-to-measure program"|"The made to measure program involves no systematic intervention. The psychologist is asked to choose among the two possible therapies (Cognitive training therapy or Reminiscence therapy) the one more suitable for the patient after considering his clinical characteristics including socio-demographic characteristics, disease severity or cognitive and behavioural disturbance. It is an individualized approach emphasizing the importance of flexibility to allow adjustment to individual needs."
16300035|NCT00646256|Behavioral|COGPACK training, psychoeducation|Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)
16300036|NCT00646230|Drug|fenretinide|
16300037|NCT00646230|Other|high performance liquid chromatography|
16300038|NCT00646230|Other|pharmacological study|
16300039|NCT00646217|Behavioral|Self Care Talk|6 weekly telephone sessions
16300040|NCT00646204|Drug|Memantine|10 mg bid
16300041|NCT00646204|Drug|placebo|2 tabs bid
16300042|NCT00646191|Drug|adalimumab|40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
16300043|NCT00646191|Drug|adalimumab|40 mg weekly through Week 48 (OL Week 12 - 48)
16300044|NCT00646191|Drug|adalimumab|80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
16300045|NCT00646178|Drug|adalimumab|40 mg adalimumab eow Week 0 - Week 12
16300046|NCT00646178|Drug|placebo for adalimumab|placebo eow Week 0 - Week 12
16300047|NCT00646165|Drug|Forodesine|
16300048|NCT00646152|Drug|Poly-ICLC|
16300049|NCT00646139|Drug|Src kinase inhibitor KX2-391|
16300050|NCT00646139|Other|immunoenzyme technique|
16300051|NCT00646139|Other|pharmacological study|
16300052|NCT00646126|Drug|Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)|Standard three day regimen
16300053|NCT00646126|Drug|placebo tablet similar to active drug in shape and size|Dosage similar to active drug(standard three days regimen)
16300054|NCT00646113|Device|OsseoSpeed™ TX 3.0S|OsseoSpeed™ TX 3.0 mm diameter
16300055|NCT00646100|Procedure|transcatheter arterial chemoembolization|chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.
16300056|NCT00646087|Drug|Ketamine|0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
16300057|NCT00646087|Drug|Ketamine/Saline|0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
16300058|NCT00646074|Behavioral|Self-Care Talk|6 conversational sessions
16300059|NCT00646061|Drug|buscopan|
16300060|NCT00646048|Device|TriVascular Stent-Graft System|TriVascular Stent-Graft System
16300061|NCT00646035|Drug|paricalcitol capsules|baseline iPTH/60
16300062|NCT00646009|Drug|budesonide/formoterol|
16300063|NCT00646009|Drug|fluticasone/salmeterol|
16300064|NCT00646009|Drug|albuterol|
16300065|NCT00645996|Dietary Supplement|Probiotics (L.acidophilus and B.lactis)|2.1 X 109 L.acidophilus and B.lactis
16300066|NCT00645996|Dietary Supplement|Cornflor|Cornflour 2 gram daily
16300067|NCT00645983|Dietary Supplement|Chamomile Extract|220 mg - 1100 mg daily
16300068|NCT00645983|Other|Placebo|1 to 5 capsules daily
16300069|NCT00645957|Procedure|penrose drain|incision and drainage of the infection with placement of a penrose drain
16300070|NCT00645957|Procedure|red rubber drain|incision and drainage of infection and placement of a red rubber drain
16300071|NCT00645944|Drug|Eszopiclone|Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
16300072|NCT00645944|Drug|Placebo|"Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
16300073|NCT00645931|Behavioral|protein and calorie controlled diet and self-hypnotic relaxation|daily
16300074|NCT00645918|Drug|clopidogrel|oral, 75 mg daily for 6 months starting on day of randomization
16300075|NCT00645918|Drug|placebo|oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
16300076|NCT00645918|Drug|clopidogrel|oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization
16300077|NCT00645905|Drug|adalimumab|OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
16300080|NCT00645892|Drug|placebo for adalimumab|OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24
16300081|NCT00645879|Drug|ornithine alpha ketoglutarate|A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effect, drug will be taken for 30 weeks.
16300082|NCT00645879|Drug|glutamine|A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.
16300083|NCT00645879|Drug|disodium citrate|Dose: 7.5 mEq/Kg or 658 mg/kg up to 16 g per day Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.
16300084|NCT00645866|Drug|capecitabine|
16300085|NCT00645866|Drug|docetaxel|
16300086|NCT00645866|Drug|epirubicin hydrochloride|
16300087|NCT00645866|Other|laboratory biomarker analysis|
16300088|NCT00645866|Other|pharmacogenomic studies|
16300089|NCT00645866|Procedure|biopsy|
16300090|NCT00645866|Procedure|neoadjuvant therapy|
16300091|NCT00645866|Procedure|therapeutic surgical procedure|
16300092|NCT00645853|Drug|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
16300093|NCT00645853|Drug|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
16300094|NCT00645840|Drug|Anakinra|Patients will receive daily anakinra therapy for 28 days
16300095|NCT00645827|Other|IICE Dosing|Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
16300096|NCT00645827|Other|Healthcare Provider dosing|Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
16300097|NCT00645814|Drug|placebo for adalimumab|80 mg at Week 0 and 40 mg eow through Week 11
16300098|NCT00645814|Drug|adalimumab|80 mg at Week 0 and 40 mg eow through Week 11
16300099|NCT00645814|Drug|adalimumab|80 mg at Week 0 and 40 mg weekly through Week 11
16300100|NCT00645801|Drug|lubiprostone (Amitiza)|24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total
16300101|NCT00645801|Drug|Placebo|Amitiza Placebo
16300102|NCT00645788|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days
16300103|NCT00645788|Drug|Placebo|50 mg matching placebo powder formulation twice a day for 28 days
16300104|NCT00645788|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
16300105|NCT00645788|Drug|Placebo|75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
16300106|NCT00645775|Dietary Supplement|IGOB131|Comparison of 250 mg per day of Irvingia gabonensis to placebo
16300107|NCT00645762|Device|RS-Series Rhinosinusitis Treatment System|Single arm
16300108|NCT00645762|Device|FinESS Balloon|
16300109|NCT00645749|Biological|Helminth ova|2500 ova per dose (liquid form)
16300110|NCT00645736|Other|No intervention|No intervention
16300111|NCT00645723|Drug|Colistin|intravenous colistin and nebulized colistin
16300112|NCT00645723|Drug|Colistin and saline solution|intravenous colistin and nebulized saline solution
16300113|NCT00645710|Drug|gemcitabine hydrochloride|Given IV
16300114|NCT00645710|Drug|floxuridine|Given via hepatic arterial infusion
16300115|NCT00645710|Genetic|proteomic profiling|Correlative studies
16300116|NCT00645710|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Correlative studies
16300117|NCT00645710|Other|liquid chromatography|Correlative studies
16300118|NCT00645710|Radiation|yttrium Y 90 anti-CEA monoclonal antibody cT84.66|Given IV
16300119|NCT00645710|Other|laboratory biomarker analysis|Correlative studies
16300120|NCT00645710|Other|mass spectrometry|Correlative studies
16300121|NCT00645710|Other|pharmacological study|Correlative studies
16300122|NCT00645684|Procedure|Gastrointestinal Anastomosis|Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
16300123|NCT00645671|Drug|0.5% Loteprednol Etabonate Ophthalmic Ointment|1/2 inch ribbon four times a day for 14 days
16300124|NCT00645671|Drug|Vehicle of Loteprednol Etabonate Ophthalmic Ointment|1/2 inch ribbon four times a day for 14 days
16300125|NCT00645658|Drug|Testim (1% testosterone gel)|Subjects apply contents of gel packet to skin daily.
16300126|NCT00645632|Drug|cisplatin|
16300127|NCT00645632|Drug|doxorubicin hydrochloride|
16300128|NCT00645632|Drug|ifosfamide|
16300129|NCT00645632|Drug|methotrexate|
16300130|NCT00645632|Procedure|adjuvant therapy|
16300131|NCT00645632|Procedure|neoadjuvant therapy|
16300132|NCT00645632|Procedure|therapeutic conventional surgery|
16300133|NCT00645606|Biological|Rituximab|rituximab :500 mg/m² every 8 weeks during 2 years
16300177|NCT00645294|Drug|Adefovir Dipivoxil|0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
16300134|NCT00645593|Drug|Gemcitabine,|Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
16300135|NCT00645593|Drug|Cisplatin|Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle.
16300136|NCT00645593|Drug|Cetuximab|Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
16300137|NCT00645580|Drug|Fluvoxamine|Fluvoxamine 100mg/day PO for 6 weeks.
16300138|NCT00645567|Device|Unassisted Manual Transfer|No device assistance
16300139|NCT00645567|Device|Standard Transfer Board|Flat surface board
16300140|NCT00645567|Device|Glide n' Go|Flip down power lift chair
16300141|NCT00645567|Device|Easy Reach lift|Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height
16300142|NCT00645567|Device|Ryno lift|Lift for the wheelchair
16300143|NCT00645554|Drug|Galantamine oral solution|
16300144|NCT00645541|Procedure|Axillary Reverse Mapping|Lymphazurin, isosulfan blue dye, injected into arm then a standard axillary lymph node surgery to remove any blue dyed lymph nodes found (lymph nodes that have traveled down the drainage pathways).
16300145|NCT00645528|Other|Insulin Education Class|Participation in an Insulin Education Class at week 0 and week 2
16300146|NCT00645515|Drug|Ziprasidone|Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
16300147|NCT00645515|Drug|Risperidone|Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
16300148|NCT00645502|Drug|risperidone|
16300149|NCT00645489|Behavioral|psychoeducational|Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
16300150|NCT00645489|Other|wait list|Wait list
16300151|NCT00645463|Drug|CP-945,598|20 mg CP-945,598 + 240 mg MR Diltiazem
16300152|NCT00645463|Drug|CP-945,598|20 mg CP-945,598 alone
16300153|NCT00645450|Drug|Propranolol|Weekly doses of short and long acting propranolol (Inderal, Inderal LA, Hemangeol, Inderal XL) following recollection of traumatic memory
16300154|NCT00645450|Drug|Placebo|Weekly doses of placebo (inactive pill) following recollection of traumatic memory
16300155|NCT00645437|Drug|Levofloxacin|
16300156|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
16300157|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
16300158|NCT00645424|Drug|atorvastatin|Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
16300159|NCT00645411|Biological|Cell culture-derived influenza subunit vaccine (cTIV)|One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
16300160|NCT00645411|Biological|Egg derived influenza subunit vaccine (eTIV)|One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
16300161|NCT00645411|Biological|Cell culture-derived influenza subunit vaccine (cTIV)|Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
16300162|NCT00645411|Biological|Egg derived influenza subunit vaccine (eTIV)|Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
16300163|NCT00645398|Drug|Pregabalin|Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
16300164|NCT00645398|Drug|Pregabalin|Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
16300165|NCT00645398|Drug|Pregabalin|Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
16300166|NCT00645398|Drug|Placebo|Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
16300167|NCT00645385|Other|MRS Spectroscopy|"Magnetic Resonance Spectroscopy uses a continuous band of radio wave frequencies to excite hydrogen atoms in a variety of chemical compounds other than water. These compounds absorb and emit radio energy at characteristic frequencies, or spectra, that can be used to identify them. Generally, a color image is created by assigning a hue to each distinctive spectral emission. This comprises the spectroscopy part of MRS. MRS is still experimental, and is available in only a few research centers.
~Physicians mainly use MRS to study the brain and disorders such as epilepsy, Alzheimer's disease, brain tumors, and the effects of drugs on brain growth and metabolism. The technique is also useful in evaluating metabolic disorders of the muscles and nervous system. MRS is a noninvasive scan similar to an MRI that may be done at the same time as an MRI."
16300168|NCT00645372|Drug|Risperidone|Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6
16300169|NCT00645372|Drug|Ziprasidone|Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6
16300170|NCT00645359|Procedure|diffusion MRI|Diffusion MRI involves using MRI scanning to measure water transport at the cellular level. In this study, dMRI is being used to measure the response of tumors to chemotherapy.
16300171|NCT00645346|Biological|GBS glycoconjugate vaccine|Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.
16300172|NCT00645346|Biological|Placebo|Subjects will receive one dose of placebo
16300173|NCT00645333|Drug|MK-0752, Docetaxel, Pegfilgrastim|MK-0752 in escalating doses of 300, 450, 600, and 800 mg given orally on days 1-3, followed by docetaxel 80 mg/m2 day 8 and pegfilgrastim 6 mg SQ on day 9
16300174|NCT00645320|Drug|Ziprasidone|Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
16300175|NCT00645307|Drug|Extended Release OROS® Paliperidone|
16300176|NCT00645294|Drug|Adefovir dipivoxil|0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
16300178|NCT00645294|Drug|Adefovir Dipivoxil|ADV 10 mg on Day 1
16300179|NCT00645281|Drug|tolterodine extended release|Tolterodine ER capsule 4 mg daily for 12 weeks
16300180|NCT00645268|Drug|sildenafil|In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.
16300181|NCT00645268|Drug|placebo|In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.
16300182|NCT00645268|Drug|sildenafil|Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
16300183|NCT00645255|Drug|placebo|placebo one capsule daily
16300184|NCT00645255|Drug|sibutramine or placebo|one capsule daily
16300185|NCT00645242|Drug|fluconazole|Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
16300186|NCT00645229|Drug|Ziprasidone|Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
16300187|NCT00645216|Drug|CP-945,598|Subjects take CP-945,598 alone for 21 days
16300188|NCT00645216|Drug|CP-945,598|Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21
16300189|NCT00645203|Drug|cefdinir|cefdinir oral suspension, 25 mg/kg once daily for 10 days
16300190|NCT00645190|Drug|Galantamine HBr|
16300191|NCT00645177|Drug|ABT-869|0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
16300192|NCT00645177|Drug|paclitaxel|90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks
16300193|NCT00645177|Drug|Placebo for ABT-869|0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
16300194|NCT00645164|Other|Ointment Vehicle|Subject acts as own control. 20 mg under Finn chambers
16300195|NCT00645164|Drug|Xenaderm|20 mg under Finn chambers
16300196|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
16300197|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
16300198|NCT00645151|Drug|Atorvastatin|Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
16300199|NCT00645138|Procedure|Paravertebral Block|"Sedation will be provided with midazolam and fentanyl. The transverse processes of T1-T6 will be located using ultrasound guidance. The area will be prepped with betadine. At each level, a 21 Gauge, 4-inch Stimuplex needle will be inserted in order to make contact with the transverse process. Once the transverse process has been located, the needle will be walked off the process and inserted 1 cm deep to its inferior border. After negative aspiration, 3 mL of 1.5% mepivacaine with epinephrine 1:200,000 and bicarbonate and 3 mL of 0.5% bupivacaine with epinephrine 1:200,000 will be injected. Sedation will be provided with 50-100 mcg/kg/min of propofol during the surgical procedure. Approximately 20 minutes before the end of the procedure, 4 mg of zofran will be administered."
16300200|NCT00645138|Procedure|General Anesthesia|Patients in the general anesthesia group will receive midazolam preoperatively for anxiolysis. Anesthesia will be induced with propofol and fentanyl. An LMA will be inserted and anesthesia maintained with sevoflurane in air and oxygen. 4 mg of zofran will be administered approximately 20 minutes before the end of the surgical procedure. The LMA will be removed and the patient will be transported to the PACU at the conclusion of the surgery.
16300201|NCT00645125|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL
16300202|NCT00645125|Drug|amoxicillin|2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
16300203|NCT00645112|Drug|cefdinir (Omnicef)|oral suspension, 7 mg/kg every 12 hours for 5 days
16300204|NCT00645112|Drug|azithromycin|oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
16300205|NCT00645099|Drug|olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
16300206|NCT00645099|Drug|paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
16300207|NCT00645086|Drug|clarithromycin extended-release tablets|5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
16300208|NCT00645086|Drug|clarithromycin immediate-release tablets|7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
16300209|NCT00645073|Drug|cefdinir (Omnicef)|Two 300 mg cefdinir capsules on Study Days 1-10.
16300210|NCT00645073|Drug|levofloxacin|Two 250 mg levofloxacin capsules on Study Days 1-10
16300211|NCT00645060|Other|high performance liquid chromatography|Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples
16300212|NCT00645060|Other|pharmacological study|Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples
16300213|NCT00645060|Procedure|radionuclide imaging|1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion
16300214|NCT00645060|Procedure|single photon emission computed tomography|2 days and 3-5 days post antibody infusion
16300215|NCT00645060|Radiation|yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A|Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation
16300216|NCT00645047|Behavioral|Telemedicine CBT|Use of Videoconfrence Technology To Provide Cognitive Therapy
16300217|NCT00645047|Behavioral|In-Person CBT|In-Person Provision Of Cognitive Therapy
16300218|NCT00645034|Drug|placebo|placebo by mouth as a single dose
16300219|NCT00645034|Drug|sildenafil|sildenafil 100 mg by mouth as a single dose
16300220|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with mild hepatic function
16300221|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with moderate hepatic function
16300222|NCT00645021|Drug|CP-945,598|Administration of CP-945,598 in subjects with normal hepatic function
16300223|NCT00644995|Behavioral|Step Up Wellness Program|Participants in the Step Up Wellness program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.
16300224|NCT00644995|Behavioral|Usual care|Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
16300225|NCT00644982|Drug|sertraline|Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
16300226|NCT00644982|Drug|venlafaxine XR|Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
16300227|NCT00644969|Drug|placebo|Randomization 2:1 treatment to placebo
16300228|NCT00644969|Drug|varenicline (CP-526,555)|One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
16300229|NCT00644956|Drug|tadalafil|tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
16300230|NCT00644956|Drug|sildenafil|sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
16300231|NCT00644943|Drug|cefdinir (Omnicef)|oral suspension (7 mg/kg, ql2hr) for 5 days
16300232|NCT00644943|Drug|amoxicillin|oral suspension (45 mg/kg/day, q l2 hours) for 10 days
16300233|NCT00644930|Device|the application of NPPV|ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. BIPAP Vision machine (Respironics, PA, USA) were used for NPPV.
16300234|NCT00644930|Device|invasive ventilation|Standard therapy group (invasive ventilation). Patients in need of endotracheal intubation were mechanically ventilated with Amadeus (Hamilton, Via Nova, Switzerland) and Esprit (Respironics, PA, USA) ventilators in the assist-control or synchronized intermittent mandatory ventilation (SIMV) mode.
16300235|NCT00644917|Drug|Xenaderm|20mg under Finn chambers
16300236|NCT00644917|Drug|Placebo|20mg under Finn chambers
16300237|NCT00644904|Dietary Supplement|Vitamin D3|
16300238|NCT00644904|Dietary Supplement|Vitamin D3|
16300239|NCT00644891|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
16300240|NCT00644891|Drug|amoxicillin|2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml
16300241|NCT00644878|Drug|Nilotinib|Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.
16300242|NCT00644852|Other|Retrospective chart review study|Retrospective study chart review long acting risperidone
16300243|NCT00644839|Drug|CP-945,598|Administration of CP-945,598 alone in period 1
16300244|NCT00644839|Drug|CP-945,598|Adminstration of CP-945,598 with omeprazole in period 2
16300245|NCT00644826|Behavioral|preventive home visit|A multidimensional geriatric assessment within the dimensions: cognition, health related functioning, risk of falling, nutritional status, social situation, economic situation, mood. Two more home visits: (1) home counseling visit 2-3 weeks after assessment (2) booster session 1 month after home counseling visit
16300246|NCT00644813|Other|Scapular with glenoid neck fractures|
16300247|NCT00644800|Drug|Ziprasidone|Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
16300248|NCT00644787|Drug|Fentanyl 1-day transdermal patch (Titration Phase)|Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.
16300249|NCT00644787|Drug|Fentanyl 1-day transdermal patch (Double Blind Phase)|Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
16300250|NCT00644787|Drug|Fentanyl 3-day transdermal patch (Double Blind Phase)|Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
16300251|NCT00644787|Drug|Placebo|Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
16300252|NCT00644787|Drug|Placebo|Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
16300253|NCT00644774|Drug|cefdinir (Omnicef)|2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml
16300254|NCT00644774|Drug|azithromycin|2.5 ml of cherry flavored oral suspension 100 mg/5 ml
16300255|NCT00644761|Drug|Adefovir Dipivoxil|Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
16300256|NCT00644748|Drug|gabapentin|"Gabapentin oral capsules:
~Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg"
16300257|NCT00644735|Drug|Esomeprazole|
16300258|NCT00644735|Drug|Lansoprazole|
16300259|NCT00644722|Device|MacIntosh Green Lite (metal single use laryngoscope blades)|metal single use laryngoscope blades
16300260|NCT00644722|Device|MacIntosh Green Spec II (metal reusable laryngoscope blades)|metal reusable laryngoscope blades
16300261|NCT00644709|Drug|Atorvastatin|Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.
16300297|NCT00644436|Device|Tetrix|Single topical application
16300387|NCT00643851|Drug|Dapagliflozin|Tablets, Oral, Once daily, 24 weeks
16300262|NCT00644696|Drug|Irinotecan and Bortezomib|Dose level-1a: IV Irinotecan 30 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-1: IV Irinotecan 35 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-2: IV Irinotecan 40 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-3: IV Irinotecan 45 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-4: IV Irinotecan 50 mg/m2/day, IV bortezomib 1.2mg/m2/day
16300263|NCT00644670|Drug|Atorvastatin|In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
16300264|NCT00644670|Drug|Atorvastatin|In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
16300265|NCT00644657|Drug|Clopidogrel|All subjects will receive a 300 mg loading dose
16300266|NCT00644644|Other|Rapid Response Team (NTX wireless monitoring system)|If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.
16300267|NCT00644631|Drug|sildenafil|sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
16300268|NCT00644631|Drug|placebo|placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
16300269|NCT00644618|Drug|gemcitabine|a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
16300270|NCT00644618|Other|125I brachytherapy PLUS gemcitabine|125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
16300271|NCT00644605|Drug|sildenafil|sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
16300272|NCT00644605|Drug|sildenafil|sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
16300273|NCT00644605|Drug|placebo|placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
16300274|NCT00644605|Drug|sildenafil|sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
16300275|NCT00644592|Drug|Fenofibrate capsule daily for 4 weeks|Placebo capsule daily for 4 weeks
16300276|NCT00644592|Drug|Fenofibrate|160 mg/day orally for 4 weeks
16300277|NCT00644579|Drug|bLAC|bLAC high and low dose and placebo
16300278|NCT00644579|Drug|Placebo|Placebo
16300279|NCT00644566|Other|Shared Care|A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician. The psychologist offered regular appointments and psychoeducation. On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.
16300280|NCT00644553|Drug|Clarithromycin|Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
16300281|NCT00644553|Drug|Amoxicillin|Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
16300282|NCT00644540|Biological|Influenza Trivalent Inactivated Vaccines|"This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
~Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
~Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm."
16300283|NCT00644540|Biological|Influenza Trivalent Inactivated Vaccines|"This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
~Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
~Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm."
16300284|NCT00644527|Other|Purpose designed music and sound listening program|Listening to one of two different specific music programs (Group A and B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
16300285|NCT00644527|Other|Sham music for depression|Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
16300286|NCT00644514|Biological|Endotoxin - lipopolysaccharide (LPS)|Nebulized 5000EU, 10,000EU, 20,000EU endotoxin doses delivered to completion. Nebulized dose inhaled 30 minutes apart if no adverse events occur after the previous dose. Fiberoptic Bronchoscopy with Bronchoalveolar Lavage (BAL) and brush samples performed 24 hours after LPS nebulization.
16300287|NCT00644501|Drug|DiaPep277|1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.
16300288|NCT00644488|Drug|BMS-641988 (AR#2)|Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
16300289|NCT00644475|Drug|Imidapril|tablets; 5, 10, 15, 20 mg; od; 12 weeks
16300290|NCT00644475|Drug|Candesartan|tablets; 8, 16, 24, and 32 mg; od; 12 weeks
16300291|NCT00644462|Device|PulmoTrack® 2010 with WIM-PC™ Technologies|wheeze detection during dynamic bronchial situations in infants
16300292|NCT00644449|Other|placebo|placebo
16300293|NCT00644449|Drug|azithromycin SR (Zithromax; compound: CP-62,993)|azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
16300294|NCT00644449|Other|placebo|placebo
16300295|NCT00644449|Drug|levofloxacin|500 mg (two 250 mg capsules) by mouth once daily for 7 days
16300296|NCT00644436|Device|Tetrix|single topical application
16300298|NCT00644423|Drug|Omega-3 Fatty Acid|One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
16300299|NCT00644423|Drug|Placebo|Matching Placebo
16300300|NCT00644410|Biological|Mesenchymal stromal cell|Mesenchymal stromal cells 20 - 40 mill.
16300301|NCT00644410|Biological|Saline|12 injection with 0.2 ml saline
16300302|NCT00644397|Device|95-degree Angled Blade Plate|
16300303|NCT00644397|Device|4.5mm Condylar Locking Plate|
16300304|NCT00644384|Drug|acitretin|
16300305|NCT00644384|Genetic|gene expression analysis|
16300306|NCT00644384|Genetic|northern blotting|
16300307|NCT00644384|Genetic|polymerase chain reaction|
16300308|NCT00644384|Genetic|protein expression analysis|
16300309|NCT00644384|Other|laboratory biomarker analysis|
16300310|NCT00644371|Drug|Ibritumomab Tiuxetan (Zevalin)|"Conditioning Regimen
~Rituximab, 250 mg/m2 on days -21 and -14.
~Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.
~Chemotherapy:
~Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
~Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.
~Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
~Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
~Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
~Melphalan 70 mg/m2/day on day -2 as a 15-min infusion."
16300311|NCT00644358|Drug|vilazodone|titration to 40 milligrams (mg) every day (qd) for 1 year
16300312|NCT00644332|Drug|Ranolazine|Oral dosage form.
16300313|NCT00644319|Drug|ibuprofen|
16300314|NCT00644319|Drug|morphine sulfate|
16300315|NCT00644319|Procedure|management of therapy complications|
16300316|NCT00644319|Procedure|pleurodesis|
16300317|NCT00644306|Drug|Thalidomide|100 mg/day continuously for 18 months
16300318|NCT00644306|Drug|melphalan, prednisone|12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
16300319|NCT00644306|Drug|melphalan, prednisone, thalidomide|12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
16300320|NCT00644293|Drug|azithromycin (Zithromax)|azithromycin 500 mg tablet by mouth once daily for 3 days
16300321|NCT00644293|Drug|placebo|placebo
16300322|NCT00644293|Drug|azithromycin SR|azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
16300323|NCT00644293|Drug|placebo|placebo
16300324|NCT00644280|Drug|Ranibizumab|intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
16300325|NCT00644267|Behavioral|Telemedicine|Telemedicine reporting of blood pressure, weight, physical activity
16300326|NCT00644254|Procedure|Pancreatic resection|PPPD, Whipple, Total pancreatectomy or left pancreatectomy.
16300327|NCT00644241|Biological|stem cell harvest|stem cells will be harvested from the iliac crest of the patients
16300328|NCT00644241|Procedure|angiographic transplantation of stem cells|autologous bone marrow derived stem cells will be transplanted in the gastroduodenal artery of the patient angiographically
16300329|NCT00644228|Drug|Bortezomib|Given IV
16300330|NCT00644228|Drug|Dexamethasone|Given PO
16300331|NCT00644228|Other|Laboratory Biomarker Analysis|Optional correlative studies
16300332|NCT00644228|Drug|Lenalidomide|Given PO
16300333|NCT00644215|Drug|5-FU and Mitomycin|"5-FU injection 5mg
~Mitomycin drop 0.02%"
16300334|NCT00644202|Behavioral|Counseling Sessions|Counseling Sessions at each study visit around diet and physical activity from a registered dietician
16300335|NCT00644202|Behavioral|Specialized Website|Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants
16300336|NCT00644202|Behavioral|Telephone Counseling Calls|5 telephone calls with a health counselor, lasting 15-20 minutes each.
16300337|NCT00644189|Drug|Clofarabine|Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
16300338|NCT00644176|Drug|azithromycin immediate release (Zithromax)|azithromycin IR 500 mg tablet by mouth for 1 dose
16300339|NCT00644176|Other|placebo|placebo
16300340|NCT00644176|Drug|azithromycin SR|2.0 g by mouth in the form of liquid for 1 dose
16300341|NCT00644176|Other|placebo|placebo
16300342|NCT00644163|Behavioral|Eban HIV/STD Risk Reduction Intervention|The eight-session Eban HIV/STD Risk Reduction Intervention is embedded in a cultural context and is gender tailored in its prevention messages and activities. Sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations.
16300343|NCT00644163|Behavioral|Eban Health Promotion Intervention|The eight-session Eban Health Promotion Intervention is guided by a social cognitive approach that engages health promotion skills. Sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence.
16300344|NCT00644150|Behavioral|Physician Ai Shi Zi training|This training uses a curriculum developed specifically for Project Ai Shi Zi and includes training in stigma; risk-reduction counseling; and quality HIV/STI diagnosis, treatment, and management. Physician training will consist of multiple components: an orientation workshop on fundamental knowledge and skills of HIV/STI treatment and prevention, a 3-month practice period, a 3-month post-practice seminar on preventive counseling, another 3-month practice period, and a 6-month post-practice seminar on clinical HIV and STI management. The practice periods will promote learning-by-doing to further enhance physicians' abilities to deliver high quality, integrated HIV/STI prevention and treatment. Post-practice seminars will allow participants to share experiences gained during the previous 3-month practice period.
16300345|NCT00644150|Drug|Standard care|If an STI is confirmed by a lab test, participants will receive standard of care treatment. Gonorrhea will be treated with a single dose of 250 mg of ceftriaxone sodium administered by intramuscular injection. If patients are allergic to ceftriaxone, they will be treated with azithromycin (2 g single oral dose). Chlamydia will be treated with azithromycin (1 g single oral dose).
16300346|NCT00644150|Behavioral|Patient risk-reduction counseling|On the initial visit, participants will receive HIV/STI risk-behavior counseling from the physician trained in Ai Shi Zi. The process is based on motivational interviewing techniques and will include discussing topics such as partner notification, HIV/STI prevention, and expected difficulties in changing behaviors. This risk-reduction model encourages the HIV/STI-infected or -uninfected person to develop a risk-reduction plan. The objective is to decrease the chance of infection for that individual and for others, too. Patients will develop a list of risk-reduction strategies to follow.
16300347|NCT00644137|Drug|pregabalin|Help stop smoking
16300348|NCT00644137|Other|cigarettes|help stop smoking with study medication
16300349|NCT00644124|Drug|aflibercept|in combination with standard treatment R-CHOP
16300350|NCT00644111|Drug|Bupivicaine, Hydromorphone|0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
16300351|NCT00644111|Drug|Saline Placebo|Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
16300352|NCT00644098|Dietary Supplement|soluble fibre complex and medium chain triglycerides|
16300353|NCT00644098|Dietary Supplement|cellulose and soybean oil|
16300354|NCT00644085|Drug|aspirin|oral administration of aspirin 100 mg
16300355|NCT00644085|Drug|placebo|oral administration of placebo
16300356|NCT00644072|Drug|SNX-5422|
16300357|NCT00644059|Biological|Adjuvanted trivalent inactivated subunit influenza vaccine|Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
16300358|NCT00644059|Biological|Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine|For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
16300359|NCT00644059|Biological|Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine|"Meningococcal vaccine: two IM injections
~Tick-borne encephalitis vaccine: two IM injections"
16300360|NCT00644046|Behavioral|multidisciplinary predialysis education|teaching of renal knowledges, dietary support and recall of period medical visits
16300361|NCT00644033|Drug|Frovatriptan|2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
16300362|NCT00644033|Drug|Frovatriptan|2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
16300363|NCT00644033|Drug|Placebo|placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.
16300364|NCT00644020|Drug|mitomycin, Fluorouracil|All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
16300365|NCT00644007|Drug|Placebo|Placebo as a substitute of SK3530 100mg
16300366|NCT00644007|Drug|SK3530|SK3530 100 mg
16300367|NCT00643994|Radiation|CyberKnife Stereotactic Radiosurgery|36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
16300368|NCT00643981|Biological|MESENDO|"2 ml of the final cell mixture will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel."
16300369|NCT00643968|Drug|EFV+TDF|
16300370|NCT00643968|Drug|EFV+3TC+TDF|
16300371|NCT00643955|Other|muscle strength|muscle strength
16300372|NCT00643942|Other|No intervention required|
16300373|NCT00643929|Drug|Eltrombopag|Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo
16300374|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 9 and 12 months)
16300375|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 9 and 15 months)
16300376|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 12 and 15 months)
16300377|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 15 months)
16300378|NCT00643916|Biological|Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)|0.5 mL, Intramuscular (at age 18 months)
16300379|NCT00643916|Biological|A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)|0.5 mL, Subcutaneous (at 3 years to <6 years of age)
16300380|NCT00643903|Behavioral|Cognitive behavioral coping effectiveness training|Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
16300381|NCT00643903|Behavioral|Standard care|Participants will receive standard of care for HIV infections.
16300382|NCT00643903|Behavioral|Single group workshop on coping effectiveness training|Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.
16300383|NCT00643890|Genetic|Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus|One-time bilateral administration of rAAV-GAD at 1X10^12 vector genomes in 35 uL.
16300384|NCT00643877|Procedure|Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR|PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
16300385|NCT00643877|Procedure|surgery|radical surgery only
16300386|NCT00643864|Behavioral|mirror training|"Training will be performed one-on-one by an investigator in a quiet room, one hour a day, five days a week, for four weeks. Attendance will be recorded. The mirror-box apparatus consists of an 18 x 24 vertical mirror secured in the center of a wooden platform. During training, the mirror-box will be placed on a table in front of the subject so that the mirror is perpendicular to the chest, slightly lateral of midline. Subjects will be asked to attend to the mirror reflection of their unaffected hand performing a series of tasks, while keeping their affected limb still. At the end of the four week training period, posttests will be administered by the same Occupational Therapist who performed the pretests."
16300388|NCT00643851|Drug|Metformin XR|Tablets, Oral, Once daily, 24 weeks
16300389|NCT00643838|Drug|Kalinox 170 bar|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
16300390|NCT00643825|Drug|Temozolomide|Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
16300391|NCT00643825|Drug|Temozolomide|Observation till Progression then rechallenging with TMZ
16300392|NCT00643812|Other|Installation of gun locker in household|Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Early arm received gun lockers at baseline.
16300393|NCT00643812|Other|Installation of gun locker in household|"Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Late arm received the gun locker 12 months after baseline."
16300394|NCT00643799|Drug|Celecoxib|200 mg oral capsule once daily for 6 months
16300395|NCT00643799|Drug|Naproxen|500 mg oral capsule twice daily for 6 months
16300396|NCT00643799|Drug|Placebo|Matched oral placebo for 6 months
16300397|NCT00643786|Drug|Oxygène|Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
16300398|NCT00643786|Drug|Air Médical|Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
16300399|NCT00643773|Dietary Supplement|Leucine|capsules are 0.5g, subjects take 5 capsules with every main meal for 6 months In total this is 15 capsules per day
16300400|NCT00643773|Dietary Supplement|Wheat flour|Wheat flour
16300401|NCT00643760|Drug|Placebo|placebo
16300402|NCT00643760|Drug|GEn 1200mg/day|gabapentin enacarbil 1200mg/day
16300403|NCT00643760|Drug|GEn 2400mg/day|gabapentin enacarbil 2400mg/day
16300404|NCT00643760|Drug|GEn 3600mg/day|gabapentin enacarbil 3600mg/day
16300405|NCT00643760|Drug|Pregabalin|pregabalin 300mg/day
16300406|NCT00643747|Biological|tgAAG76 (rAAV 2/2.hRPE65p.hRPE65)|Single subretinal injection of vector suspension; up to 3x10e12 vector particles
16300407|NCT00643734|Drug|azithromycin sustained release|azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
16300408|NCT00643734|Other|placebo|placebo
16300409|NCT00643734|Drug|levofloxacin|500 mg (two 250 mg capsules) by mouth once daily for 7 days
16300410|NCT00643734|Other|placebo|placebo
16300411|NCT00643721|Other|dehydration|dehydration to 3% and 5% loss of total body water
16300412|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group A, one point per ovary.
16300413|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group B, two points per ovary.
16300414|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group c, three points per ovary.
16300415|NCT00643708|Procedure|ovarian interstitial laser treatment|Different dose of laser: group D, four-five points per ovary.
16300416|NCT00643695|Behavioral|Home-based walking program|The exercise intervention is a 12 week home-based exercise program. Ideally Individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.
16300417|NCT00643695|Other|Educational intervention|Participants in the control group will receive a packet of information regarding hepatitis C
16300418|NCT00643682|Other|Educational card|"A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy."
16300419|NCT00643669|Drug|AL-3789 Sterile Suspension|Single administration by anterior juxtascleral depot
16300420|NCT00643656|Drug|Kalinox 170 bar|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
16300421|NCT00643656|Drug|Mix of 50% oxygen and 50% nitrogen|Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
16300422|NCT00643643|Drug|Maraviroc (UK-427,857)|25 mg oral tablet once daily for 10 days
16300423|NCT00643643|Drug|Maraviroc (UK-427,857)|50 mg oral tablet twice daily for 10 days
16300424|NCT00643643|Drug|Maraviroc (UK-427,857)|100 mg oral tablet twice daily for 10 days
16300425|NCT00643643|Drug|Maraviroc (UK-427,857)|300 mg oral tablet twice daily for 10 days
16300426|NCT00643643|Other|Placebo|Matching placebo oral tablet twice daily for 10 days
16300427|NCT00643630|Device|Tetrix|Twice daily topical application
16300428|NCT00643630|Device|Tetrix|Twice daily topical application
16300429|NCT00643617|Radiation|CyberKnife Stereotactic Radiosurgery|38 Gy delivered in 4 fractions of 9.5 Gy per fraction
16300430|NCT00643604|Drug|treprostinil sodium|rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
16300431|NCT00643591|Other|imaging (dynamic PET-CT scan)|dynamic PET-CT scan
16300432|NCT00643578|Drug|formoterol|a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
16300433|NCT00643578|Drug|formoterol|a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
16300434|NCT00643578|Device|Dry Powder Inhaler (Twisthaler)|subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
16300435|NCT00643565|Drug|Standard chemotherapy|As prescribed
16300436|NCT00643565|Drug|bevacizumab [Avastin]|7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
16300437|NCT00643539|Drug|Zithromax|azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days
16300438|NCT00643539|Drug|Clamoxyl|Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
16300439|NCT00643526|Device|Pre-filled Auto-injector Containing Placebo|Participants will self-inject placebo subcutaneously at thigh and abdomen.
16300440|NCT00643500|Drug|Levetiracetam|
16300518|NCT00642980|Drug|Clindamycin|300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
16300519|NCT00642980|Drug|Placebo|Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
16300441|NCT00643487|Procedure|observation of the behavior of the infrapatellar plica|Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
16300442|NCT00643474|Device|Accu-Chek Aviva Meter|4-point daily glucose monitoring profile 3 times per week
16300443|NCT00643474|Device|Accu-Chek Aviva Meter|Frequency and timing of SMBG not specified
16300444|NCT00643461|Device|Adhesive A|Applied per manufacturer's instructions.
16300445|NCT00643461|Device|Adhesive B|Applied per manufacturer's instructions.
16300446|NCT00643461|Device|Adhesive C|Applied per manufacturer's instructions.
16300447|NCT00643448|Drug|AZD1305|AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
16300448|NCT00643448|Drug|AZD1305|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
16300449|NCT00643448|Drug|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
16300450|NCT00643435|Behavioral|Self-efficacy enhancing interviewing techniques training|Teaching by standardized patient instructors regarding use of self-efficacy enhancing interviewing techniques to be applied in patient encounters
16300451|NCT00643435|Behavioral|Control intervention|These residents receive training provided by a standardized patient instructor, regarding the common co-occurrence of chronic medical and mental health problems, without any interviewing technique discussion or training.
16300452|NCT00643422|Device|Cirrus™ HD-OCT, Carl Zeiss Meditec AG|the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.
16300453|NCT00643409|Drug|azithromycin SR (Zithromax; compound: CP-62,993)|Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
16300454|NCT00643409|Other|placebo|placebo
16300455|NCT00643409|Drug|levofloxacin|levofloxacin 500 mg capsule by mouth qd x 10 days
16300456|NCT00643409|Other|placebo|placebo
16300457|NCT00643396|Radiation|thoracic radiotherapy|
16300458|NCT00643383|Drug|Combination drug (Acetaminophen + Tramadol)|
16300459|NCT00643383|Drug|Placebo|
16300460|NCT00643370|Other|CT scan of the chest under deep inspiration breath hold|computed tomography scan of the chest under dep inspiration breath hold conditions
16300461|NCT00643357|Drug|50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)|gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
16300462|NCT00643357|Drug|50%Oxygen/50% Nitrogen premix|inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min
16300463|NCT00643344|Behavioral|Craving and Lifestyle Management through Mindfulness(CALMM+)|MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).
16300464|NCT00643331|Behavioral|Exercise|Exercise performed at gym and at home comprising strength, balance and impact exercise
16300465|NCT00643318|Radiation|CyberKnife Stereotactic Radiosurgery|"Central tumors defined as < 2 cm from carina and < 2 cm from right and left mainstem bronchus and/or < 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy)
~Peripheral tumors are defined as being > 2 cms from the carina and > 2 cms from the right and left mainstem bronchus and/or > 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)"
16300466|NCT00643305|Behavioral|Skills Building with Motivational Interviewing|Based on the Stages of Change model, participants are provided with feedback related to their current HIV risk and Motivational Interviewing strategies are used to increase motivation to decrease HIV risk behaviors. Participants are also provided with information and training in skills critical for reducing HIV risk
16300467|NCT00643305|Behavioral|Skills Building|Participants are provided with information and training in skills critical for reducing HIV risk.
16300468|NCT00643292|Drug|amoxicillin/clavulanate postassium (Augmentin ES-600)|amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
16300469|NCT00643292|Drug|azithromycin SR|azithromycin SR 60 mg/kg x 1 dose
16300470|NCT00643279|Device|Chronicle Implantable Hemodynamic Monitor|Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
16300471|NCT00643279|Other|Standard of Care|Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
16300520|NCT00642980|Drug|Clindamycin|300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
16300662|NCT00642148|Drug|Placebo|Placebo tablet and inhaler
16300663|NCT00642148|Drug|Seretide|Active comparator inhaler
16300761|NCT00641459|Other|Observational BPSD treatment study|Observational BPSD treatment study
16300472|NCT00643266|Behavioral|Recollection Training|"Participants are exposed to long lists of words. Each word is presented either visually or auditorily, and each word is repeated after a variable number of intervening words (the lag), in each the same modality, or the other modality. Participants are instructed to respond yes only to words repeated in the same modality. If a performance criterion is met, the lag is increased for the next session; if the performance criterion is not met, the same lag is repeated in the next session."
16300473|NCT00643266|Behavioral|Control|Participants view PowerPoint presentations on various topics related to memory and aging (e.g., structural brain changes, diet, stress, depression) and how each of these topics affect memory, and after each presentation, play a Jeopardy-like game to test their knowledge gain
16300474|NCT00643253|Behavioral|LC and Electronic Prompt|Women will receive: a) International Board of Certified Lactation Consultant (IBCLC) education/counseling during the pre-natal, intra-partum and post-hospital discharge period to promote early and continued exclusive breastfeeding. The protocol specifies 2 prenatal meetings, a hospital visit, and a home visit if indicated and accepted, and; b) Electronic Medical Record Prompts- will appear on the prenatal record 5 times throughout the pregnancy. They are brief discussion points re breastfeeding that the provider is asked to raise with their patients.
16300475|NCT00643240|Radiation|yttrium Y 90 anti-CD19 monoclonal antibody BU12|Patients in whom the biodistribution is as expected (unaltered) AND a HAMA response does not develop will receive a single dose of 90Y-BU-12 in a dose escalated manner to establish the maximum tolerated dose (MTD) of 90Y-BU-12 over 60 minutes on Day 0. A single course of BU-12 includes the imaging dose of 111In-BU-12 followed 7-8 days later by the therapy dose of 90YBU- 12.
16300476|NCT00643240|Radiation|111In-BU-12|Patients receive indium-111 BU-12 IV over 60 minutes on day 0
16300477|NCT00643227|Drug|clarithromycin extended release (ER)|7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
16300478|NCT00643227|Drug|azithromycin SR|Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
16300479|NCT00643214|Device|Tetrix|Twice daily topical application
16300480|NCT00643214|Device|Tetrix|Twice daily topical application
16300481|NCT00643201|Drug|Enoxaparin|solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
16300482|NCT00643201|Drug|warfarin|tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
16300483|NCT00643201|Drug|Placebo for apixaban|tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
16300484|NCT00643201|Drug|Placebo for enoxaparin|solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
16300485|NCT00643201|Drug|Placebo for warfarin|tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
16300486|NCT00643201|Drug|apixaban|tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
16300487|NCT00643188|Procedure|Radiofrequency ablation|Radiofrequency ablation of atrial fibrillation
16300488|NCT00643188|Other|Conventional treatment|The best medical treatment according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult and the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation.
16300489|NCT00643175|Behavioral|Automated follow up|Treatment of osteoporosis after hip fracture is also being targeted as a future hospital quality assessment measure. Hospitals which have no plan in place to address osteoporosis treatment after hip fracture may be cited, and may have medicare money withheld. The goal of the study is to create an automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to gather patient data in a prospective manner including the endocrinologist recommendations, adherence to medical therapy after discharge, and future fracture rates. Planned interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning, and regularly scheduled telephone follow-up.
16300490|NCT00643162|Drug|Lexapro|5mg-10mg of lexapro, daily, for 9 weeks for all study participants.
16300491|NCT00643162|Behavioral|Light touch|Light touch twice a week, for 8 weeks
16300492|NCT00643162|Behavioral|Massage|Massage twice a week, for 8 weeks.
16300493|NCT00643149|Drug|amoxicillin|10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
16300494|NCT00643149|Drug|azithromycin SR|60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat
16300495|NCT00643136|Drug|Pregabalin|Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
16300496|NCT00643136|Drug|Placebo|Matching placebo capsules twice daily for 28 days
16300497|NCT00643123|Drug|Allopurinol|300-600 mg/day over a 6 week period
16300498|NCT00643123|Other|Placebo|Inactive substance
16300499|NCT00643110|Drug|D50 glucose|D50 glucose would be administered, if necessary.
16300500|NCT00643097|Biological|PEP-3 vaccine|Given intradermally
16300501|NCT00643097|Biological|sargramostim|Given intradermally
16300502|NCT00643097|Drug|Temozolomide|Standard of care chemotherapy
16300503|NCT00643084|Procedure|low residue diet/no standard bowel preparation|low residue diet/no standard bowel preparation
16300504|NCT00643084|Procedure|standard bowel preparation|standard bowel preparation
16300505|NCT00643071|Drug|Tacrolimus|Oral
16300506|NCT00643058|Biological|LPS endotoxin|"Low challenge: saline (diluent), 5000EU, 10,000EU and 20,000EU LPS endotoxin as tolerated
~High challenge: Saline (diluent), 40,000EU and 80,000EU as tolerated
~Diluent Challenge: 3 X Sterile saline inhalation (2 ml)"
16300507|NCT00643045|Drug|Safinamide|
16300508|NCT00643045|Drug|Safinamide|
16300509|NCT00643045|Drug|Placebo|
16300510|NCT00643032|Procedure|Transcutaneous iliohypogastric|
16300511|NCT00643032|Procedure|Perioperative administration near the nerve|
16300512|NCT00643019|Behavioral|SAFE Behavioral Intervention|Group cognitive behavioral intervention sessions
16300513|NCT00643019|Other|Control|Individual Sexually Transmitted Infection Risk Reduction Counseling
16300514|NCT00643006|Behavioral|Physical exercise|Supervised walks with poles twice a week at moderate-high intensity
16300515|NCT00643006|Behavioral|Active comparator: low intensive exercise|Supervised walks once a week at low-intensity.
16300516|NCT00642993|Drug|SCH 497079|100 mg capsule administered orally
16300517|NCT00642993|Drug|Placebo|Placebo capsules matching SCH 497079 administered orally
16300521|NCT00642967|Drug|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
16300522|NCT00642954|Drug|Vorinostat|Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.
16300523|NCT00642954|Drug|Lenalidomide|Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.
16300524|NCT00642954|Drug|Dexamethasone|Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.
16300525|NCT00642941|Drug|RG1507|Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
16300526|NCT00642928|Drug|Placebo|1 capsule per day during 4 weeks
16300527|NCT00642928|Drug|BF 2.649 5 mg|one BF 2.649 capsule of 5 mg per day during 4 weeks
16300528|NCT00642928|Drug|BF 2.649 10 mg|One BF 2.649 capsule of 10 mg per day during 4 weeks
16300529|NCT00642928|Drug|BF 2.649 20 mg|One BF 2.649 capsule of 20 mg per day during 4 weeks
16300530|NCT00642928|Drug|BF 2.649 40 mg|One BF 2.649 capsule of 40 mg per day during 4 weeks
16300531|NCT00642915|Drug|Lantus, Amaryl|
16300532|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
16300533|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
16300534|NCT00642902|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
16300535|NCT00642902|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
16300536|NCT00642889|Drug|Safinamide|
16300537|NCT00642889|Drug|Safinamide|
16300538|NCT00642889|Drug|Placebo|
16300539|NCT00642876|Device|Allograft Fusion and ATLANTIS™ Cervical Plate System|The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS™ Cervical Plate System.
16300540|NCT00642876|Device|PRESTIGE® Cervical Disc|The PRESTIGE® Cervical Disc is a stainless steel device that was inserted into the intervertebral disc space. The device is composed of two metal plates that interface via a ball and socket mechanism permitting segmental spinal motion.
16300541|NCT00642863|Dietary Supplement|Ferrous Sulfate (liquid) + vitamins A and D|a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.) and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
16300542|NCT00642863|Dietary Supplement|vitamins A and D|a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
16300543|NCT00642863|Dietary Supplement|Ferrous sulfate (liquid)|Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
16300544|NCT00642850|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv monthly (starting dose)
16300545|NCT00642837|Drug|Tramadol/acetaminophen|Osteoarthritis, flexible dose depending on patients' pain relief
16300546|NCT00642837|Drug|Tramadol/acetaminophen|Post surgical neurophatic pain, flexible dose depending on patients' pain relief
16300547|NCT00642837|Drug|Tramadol/acetaminophen|Post traumatic neuropathic pain, flexible dose depending on patient pain relief
16300548|NCT00642837|Drug|Tramadol/acetaminophen|Spinal Cord Injury, flexible dose depending on patients' pain relief
16300549|NCT00642837|Drug|Tramadol/acetaminophen|Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
16300550|NCT00642837|Drug|Tramadol/acetaminophen|Diabetic Neuropathy, flexible dose depending on patients' pain relief
16300551|NCT00642837|Drug|Tramadol/acetaminophen|Post stroke pain, flexible dose depending on patients' pain relief
16300552|NCT00642837|Drug|Tramadol/acetaminophen|Low back pain, flexible dose depending on patients' pain relief
16300553|NCT00642837|Drug|Tramadol/acetaminophen|Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
16300554|NCT00642837|Drug|Tramadol/acetaminophen|Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
16300555|NCT00642824|Drug|Standard chemotherapy|As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
16300556|NCT00642824|Drug|bevacizumab [Avastin]|15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
16300557|NCT00642811|Drug|Ticagrelor|Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks
16300558|NCT00642811|Drug|Clopidogrel|(over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks
16300559|NCT00642811|Drug|Aspirin|Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study
16300560|NCT00642798|Drug|sitagliptin phosphate|Sitagliptin 100mg once daily on Day 1 for single dose, and once daily on Day4-9 for multiple dose.
16300561|NCT00642772|Other|Group Physical Therapy|12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
16300562|NCT00642759|Drug|carboplatin|Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles
16300563|NCT00642759|Drug|Nab-paclitaxel|Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles
16300564|NCT00642759|Drug|Bevacizumab|IV infusion
16300618|NCT00642460|Drug|corticosteroids|orally, as prescribed
16300619|NCT00642447|Drug|helium:oxygen mixture|
16300620|NCT00642434|Drug|carvedilol|variable
16300621|NCT00642434|Drug|metoprolol|variable
16300565|NCT00642746|Drug|Erlotinib|"Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.
~Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage."
16300566|NCT00642746|Drug|Fluorouracil|Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.
16300567|NCT00642746|Drug|Leucovorin|Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.
16300568|NCT00642746|Drug|Oxaliplatin|Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.
16300569|NCT00642746|Drug|Irinotecan|Chemotherapy agent given intravenously at 180 mg/m2.
16300570|NCT00642733|Drug|erlotinib [Tarceva]|100mg po daily
16300571|NCT00642733|Drug|gemcitabine|1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle
16300572|NCT00642720|Drug|Pegvisomant|if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly
16300573|NCT00642707|Drug|PRO 140 (humanized monoclonal antibody to CCR5)|
16300574|NCT00642707|Drug|Placebo Comparator|
16300575|NCT00642694|Drug|Escitalopram|Escitalopram 10 or 20mg qd based on symptoms at patient visit
16300576|NCT00642694|Drug|Ramelteon|Ramelteon 8 mg qd
16300577|NCT00642694|Other|Placebo|Matching placebo qd
16300578|NCT00642681|Drug|Technosphere Insulin|Technosphere® Insulin (TI) Inhalation Powder, prandial
16300579|NCT00642668|Drug|methoxy polyethylene glycol-epoetin beta|1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
16300580|NCT00642655|Drug|IVIG and Rituximab|IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22
16300581|NCT00642642|Biological|Autologous Human Fibroblasts (azficel-T)|"Collection of 3 mm post auricular skin punch biopsies.
~Administration of 3 study treatments administered 14 ± 7 days apart."
16300582|NCT00642642|Biological|Placebo|"Collection of 3 mm post auricular skin punch biopsies.
~Administration of 3 study treatments administered 14 ± 7 days apart."
16300583|NCT00642629|Drug|STA 5326 mesylate|STA 5326 mesylate 100mg taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
16300584|NCT00642629|Drug|Placebo|Placebo taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
16300585|NCT00642616|Drug|Technosphere® Insulin|Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents
16300586|NCT00642616|Drug|Usual Care|Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin
16300587|NCT00642603|Drug|capecitabine [Xeloda]|1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
16300588|NCT00642603|Drug|capecitabine [Xeloda]|1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
16300589|NCT00642603|Drug|bevacizumab [Avastin]|5 mg/kg taken intravenously on Day 1 of each 2 week cycle
16300590|NCT00642603|Drug|oxaliplatin|85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
16300591|NCT00642603|Drug|irinotecan|135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
16300592|NCT00642577|Drug|bevacizumab [Avastin]|5mg/kg iv every 2 weeks
16300593|NCT00642577|Drug|irinotecan|125mg/m2 iv weekly for 4 weeks of each 6 week cycle
16300594|NCT00642577|Drug|leucovorin|20mg/m2 iv weekly for 4 weeks of each 6 week cycle
16300595|NCT00642577|Drug|fluorouracil|500mg/m2 iv weekly for 4 weeks of each 6 week cycle
16300596|NCT00642564|Other|Observational study in Epileptic Patients|Observation study in Epileptic Patients with Migraine and Headache
16300597|NCT00642551|Dietary Supplement|menaquinone-7|180 µg menaquinone-7 daily for three years
16300598|NCT00642551|Dietary Supplement|placebo|1 placebo capsule daily for three years
16300599|NCT00642538|Drug|MKC253 Inhalation Powder|Inhalation Powder, prandial
16300600|NCT00642538|Drug|Technosphere Inhalation Powder|Inhalation Powder, prandial
16300601|NCT00642538|Drug|subcutaneous injection|10µg Exenatide, prandial
16300602|NCT00642525|Procedure|Contrast swallow radiography, endoscopy|Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
16300603|NCT00642512|Drug|dronabinol|10 - 20 mg
16300604|NCT00642512|Drug|ondansetron|8 - 16 mg
16300605|NCT00642512|Drug|dronabinol/ondansetron|10 - 20 mg/8 - 16 mg
16300606|NCT00642512|Drug|placebo|placebo
16300607|NCT00642499|Drug|Dronabinol|2.5 mg to 40 mg
16300608|NCT00642499|Drug|Placebo|placebo
16300609|NCT00642486|Other|Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)|portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.
16300610|NCT00642486|Other|Standard polysomnography (PSG)|laboratory-based testing
16300611|NCT00642473|Drug|Erlotinib|Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
16300612|NCT00642473|Drug|Metronidazole Actavis|Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
16300613|NCT00642473|Other|Non-active Moisturizing Cream|Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
16300614|NCT00642460|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
16300615|NCT00642460|Drug|Placebo|iv every 2 weeks for 12 weeks
16300616|NCT00642460|Drug|Non-steroidal anti-inflammatory drugs (NSAIDs)|as prescribed
16300617|NCT00642460|Drug|methotrexate|as prescribed
16300762|NCT00641446|Drug|budesonide|
16300622|NCT00642421|Drug|C2L-OCT-01 PR, 10 or 20 mg|The first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
16300623|NCT00642421|Drug|C2L-OCT-01 PR, 20 mg|The first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
16300624|NCT00642408|Dietary Supplement|Multiple micronutrient supplements (MMN)|Iron and folic acid: iron 60 mg and folic acid 400µg
16300625|NCT00642408|Dietary Supplement|IFA|Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).
16300626|NCT00642395|Drug|Bortezomib|bortezomib-Melphalan
16300627|NCT00642382|Device|Agilus|Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
16300628|NCT00642382|Device|Normal saline|Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
16300629|NCT00642369|Drug|quetiapine fumarate|600-750mg/day
16300630|NCT00642369|Drug|haloperidol|6-40mg/day
16300631|NCT00642356|Drug|Carbidopa/levodopa/entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
16300632|NCT00642356|Drug|Immediate release carbidopa/levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
16300633|NCT00642343|Behavioral|Evaluation of motor proficiency skills.|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
16300634|NCT00642343|Behavioral|Evaluation of motor proficiency|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
16300635|NCT00642343|Behavioral|Evaluation of motor proficiency|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
16300636|NCT00642343|Behavioral|Evaluation of motor proficiency.|The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
16300637|NCT00642330|Drug|oral ibuprofen|one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
16300638|NCT00642330|Drug|intravenous ibuprofen|one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
16300639|NCT00642317|Behavioral|Questionnaire|Questionnaire about tobacco and alcohol use, acculturation, and other related topics.
16300640|NCT00642304|Drug|methoxy polyethylene glycol-epoetin beta [C.E.R.A.]|Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
16300641|NCT00642291|Drug|Emtricitabine|emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if <30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if >=7 to <15kg; 10/2.5 mg/kg BID if >=15 to <=40 kg)
16300642|NCT00642291|Drug|Emtricitabine|emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).
16300643|NCT00642278|Drug|Canagliflozin (JNJ-28431754)|One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
16300644|NCT00642278|Drug|Sitagliptin|One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
16300645|NCT00642278|Drug|Placebo|One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
16300646|NCT00642265|Procedure|osteosynthesis|operative treatment
16300647|NCT00642265|Other|sling|conservative treatment
16300648|NCT00642252|Drug|Fluoride|Over-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
16300649|NCT00642252|Drug|Fluoride|Over-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
16300650|NCT00642239|Drug|placebo|placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
16300651|NCT00642239|Drug|Sodium Glycididazole|Sodium Glycididazole 700mg/m2 in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
16300652|NCT00642226|Procedure|Grid Laser|ETDRS Grid Laser
16300653|NCT00642226|Procedure|Vitrectomy and 20 mg triamcinolone|Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
16300654|NCT00642200|Procedure|Lichtenstein hernioplasty|
16300655|NCT00642200|Procedure|Laparoscopic TEP|
16300656|NCT00642187|Drug|budesonide|
16300657|NCT00642187|Drug|Placebo|
16300658|NCT00642174|Drug|prasugrel|Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.
16300659|NCT00642174|Drug|Clopidogrel|Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.
16300660|NCT00642161|Drug|budesonide|
16300661|NCT00642148|Drug|GW856553|Active tablet
16300664|NCT00642135|Drug|Mydriasert®|Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
16300665|NCT00642135|Drug|phenylephrine and tropicamide eyedrops|Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
16300666|NCT00642122|Drug|Budesonide|0.5mg once daily
16300667|NCT00642122|Drug|Budesonide|1mg once daily
16300668|NCT00642122|Drug|Budesonide|1mg twice daily
16300669|NCT00642122|Drug|Budesonide|2mg once daily
16300670|NCT00642122|Drug|Budesonide|4.00mcg twice daily
16300671|NCT00642109|Procedure|midurethral sling procedure|quality of life, voiding dysfunction
16300672|NCT00642096|Drug|Metoprolol Succinate|
16300673|NCT00642096|Drug|Hydrochlorothiazide|
16300674|NCT00642083|Device|Viabahn stent-graft|The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.
16300675|NCT00642057|Drug|tetrabenazine|25 mg titrated to optimal dose per patient
16300676|NCT00642044|Procedure|Corneal Collagen Crosslinking|UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
16300677|NCT00642031|Drug|Triciribine|15 mg/m^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.
16300678|NCT00642018|Drug|docetaxel|Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
16300679|NCT00642018|Drug|LY2181308 sodium|LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
16300680|NCT00642018|Drug|Prednisone|Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
16300681|NCT00642005|Procedure|Fisher and Paykel Humidifier (MR860)|Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.
16300682|NCT00642005|Procedure|Standard insufflation|No humidifier or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.
16300683|NCT00641979|Drug|budesonide|Current product
16300684|NCT00641979|Device|Budesonide|New type device
16300685|NCT00641979|Drug|Placebo|
16300686|NCT00641953|Drug|IMX-150|(0.3%) 0.5g topically BID to each foot for 4 weeks
16300687|NCT00641953|Drug|IMX-150|(0.6%) 0.5g topically BID to each foot for 4 weeks
16300688|NCT00641953|Drug|Placebo|0.5 g topically BID to each foot for 4 weeks
16300689|NCT00641940|Behavioral|Girls in Transition (GT) program|In the 11-session after-school GT program, girls learn cognitive and behavioral skills related to intrapersonal, interpersonal, and social/contextual risk factors for depression.
16300690|NCT00641940|Behavioral|Waitlist Control|Participants in the waitlist control group will complete the GT program during the third year of the study.
16300691|NCT00641927|Drug|Venlafaxine|37.5 mg - 375 mg daily, 12 Weeks
16300692|NCT00641927|Drug|Lithium Carbonate|300 mg - 2100 mg daily, 12 weeks
16300693|NCT00641914|Drug|budesonide|
16300694|NCT00641914|Drug|Placebo|
16300695|NCT00641901|Behavioral|counseling|"The 8-week study includes 3 visits to the dental facility at the Center for Women's Reproductive Health at UAB. Study visits are scheduled to coincide with pre-natal visits in the same facility.
~Each visit will include individually tailored one-to-one discussion with a dental professional coupled with a demonstration and instructions for using oral hygiene products. Home-care kits will be dispensed, to include a helpful digital video disk (DVD), a high-tech powered toothbrush, dental floss, toothpaste and alcohol-free mouth rinse and subjects will have their teeth professionally cleaned.
~First and final visits will include collection of gingival crevicular fluid and blood samples and subjects will complete pre and post study questionnaires."
16300696|NCT00641875|Procedure|Nocturnal Hemodialysis|
16300697|NCT00641862|Dietary Supplement|Vitamin B12|Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery
16300698|NCT00641862|Other|Placebo|Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
16300699|NCT00641849|Behavioral|Group A|Minimum Intervention Group A will fill out data forms at zero (0), two (2), four (4), and six (6) months.
16300700|NCT00641849|Behavioral|Group B|Maximum Intervention Group B will fill out data forms at zero (0), one (1), two (2), three (3), four (4), five (5), and six (6) months.
16300701|NCT00641836|Procedure|Transplantation of autologous endothelial progenitor cells|
16300702|NCT00641810|Behavioral|Caffeine reduction|Reduction in daily caffeine consumption from usual amounts to none.
16300703|NCT00641797|Drug|Meclizine|medication administration 25mg PO one time
16300704|NCT00641797|Other|Epley Maneuver|Patient has vestibular rehabilitation utilizing the Epley Maneuver.
16300705|NCT00641797|Drug|Lorazepam|Lorazepam 1 - 5mg PO/IV prn
16300706|NCT00641797|Drug|Diphenhydramine|25 - 50mg PO/IV once prn
16300707|NCT00641797|Drug|Ondansetron|Ondansetron 4 - 8 mg PO/IV prn
16300708|NCT00641784|Drug|Magnesium|Intravenous Magnesium 6 gram load, 3 grams/hr
16300709|NCT00641784|Drug|Nifedlipine|Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
16300710|NCT00641771|Drug|alendronate sodium (+) cholecalciferol|MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
16300759|NCT00641472|Drug|Budesonide inhalation suspension|0.5mg
16300760|NCT00641472|Drug|Montelukast Sodium|4mg or 5mg
16300763|NCT00641446|Drug|varicella zoster virus|
16300711|NCT00641771|Drug|Comparator: Placebo (unspecified)|MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
16300712|NCT00641758|Drug|Pycnogenol|Pycnogenol 100mg twice daily
16300713|NCT00641758|Drug|Placebo|Placebo 100mg twice daily
16300714|NCT00641745|Drug|Lurasidone HCl|40 - 120mg per day
16300715|NCT00641745|Drug|Risperidone|Risperidone
16300716|NCT00641732|Drug|TAK-442|TAK-442 40 mg, tablets, orally, once daily for up to 10 days.
16300717|NCT00641732|Drug|TAK-442|TAK-442 80 mg, tablets, orally, once daily for up to 10 days.
16300718|NCT00641732|Drug|TAK-442|TAK-442 10 mg, tablets, orally, twice daily for up to 10 days.
16300719|NCT00641732|Drug|TAK-442|TAK-442 20 mg, tablets, orally, twice daily for up to 10 days.
16300720|NCT00641732|Drug|TAK-442|TAK-442 40mg, tablets, orally, twice daily for up to 10 days.
16300721|NCT00641732|Drug|TAK-442|TAK-442 80 mg, tablets, orally, twice daily for up to 10 days.
16300722|NCT00641732|Drug|Enoxaparin|Enoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.
16300723|NCT00641719|Drug|Duloxetine hydrochloride|Duloxetine 40 mg QD, PO, 1 year
16300724|NCT00641719|Drug|Duloxetine hydrochloride|Duloxetine 60 mg QD, PO, 1 year
16300725|NCT00641706|Drug|vorinostat|Given orally
16300726|NCT00641706|Procedure|therapeutic conventional surgery|Patient undergoes surgery
16300727|NCT00641706|Drug|bortezomib|Given IV
16300728|NCT00641693|Drug|Budesonide|16mg Nasal Spray
16300729|NCT00641693|Drug|Budesonide|32mg Nasal Spray
16300730|NCT00641693|Drug|Budesonide|64mg Nasal Spray
16300731|NCT00641693|Drug|Placebo|
16300732|NCT00641680|Drug|Budesonide|
16300733|NCT00641680|Drug|Fluticasone propionate|
16300734|NCT00641680|Drug|Placebo|
16300735|NCT00641667|Drug|Fentanyl|Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).
16300736|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
16300737|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
16300738|NCT00641654|Drug|Pegylated interferon alfa-2a and ribavirin|Arm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks
16300739|NCT00641641|Drug|Tenofovir + emtricitabine + raltegravir.|TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
16300740|NCT00641628|Procedure|mastectomy|
16300741|NCT00641615|Biological|RNF43-721|Doses of 0.5mg, 1.0mg, 3.0mg/body/week
16300742|NCT00641602|Drug|Esomeprazole|40mg once daily
16300743|NCT00641602|Drug|Lansoprazole|30mg once daily
16300744|NCT00641589|Drug|epoetin alfa|
16300745|NCT00641576|Device|ACE CONNECT Endosseous dental implant|"Subjects in this study receive ACE CONNECT Internal-Connection dental implants to: 1)replace a missing tooth in an edentulous area of the maxilla or mandible restored with a single-unit crown (may include up to two non-adjacent areas as study sites) or, 2)subjects with an edentulous mandible will receive two implants placed in the lower canine position and restored with an implant-retained removable over-denture.
~Subjects will return for four follow-up evaluations scheduled at 6, 12, 18 and 24 months after delivery of the permanent restoration."
16300746|NCT00641563|Drug|Dexmedetomidine|Infusion of dexmedetomidine
16300747|NCT00641563|Drug|Midazolam|Midazolam infusion
16300748|NCT00641563|Drug|Remifentanil|Infusion of remifentanil
16300749|NCT00641550|Other|Physical exercise|Walking 3 times a week during 1 hours (moderate activity)
16300750|NCT00641537|Drug|Cladribine|Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
16300751|NCT00641537|Drug|Placebo|Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
16300752|NCT00641537|Drug|Cladribine|Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
16300753|NCT00641537|Drug|Cladribine|Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
16300754|NCT00641537|Drug|Placebo|Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
16300755|NCT00641524|Procedure|Phlebotomy|Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level
16300756|NCT00641511|Drug|SYN117 (nepicastat)|120 mg per day
16300757|NCT00641511|Drug|Placebo comparator|once per day placebo capsules
16300758|NCT00641498|Behavioral|Psychotherapy|Individual supportive
16300764|NCT00641433|Device|oxidized regenerated cellulose collagen-silver|Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
16300765|NCT00641433|Drug|topical silver sulfadiazine cream|Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
16300766|NCT00641420|Procedure|Fractionated Laser Resurfacing|
16300767|NCT00641407|Drug|NPL insulin|Starting dose 10 IU bedtime and then titration
16300768|NCT00641407|Drug|Insulin glargine|10 IU bedtime and then titration
16300769|NCT00641394|Behavioral|Psychotherapy: Emotional Freedom Techniques (EFT)|A form of therapy that includes cognitive reframing with somatic reinforcement through touch or tapping of specified points on the body
16300770|NCT00641394|Behavioral|Cognitive Behavioral Therapy (CBT)|A form of therapy that focuses on negative cognitions of problems, and reframing them in positive terms, but without somatic reinforcement.
16300771|NCT00641381|Drug|carmustine|150 mg/m2 day -7, -6,and -5 prior to stem cell reinfusion
16300772|NCT00641381|Drug|cyclophosphamide|100 mg/kg on day -2 prior to stem cell reinfusion
16300773|NCT00641381|Drug|etoposide|60 mg/kg on day -4 prior to stem cell reinfusion
16300774|NCT00641381|Other|pharmacological study|Prior to start of etoposide infusion, 2 hours after start of infusion, just prior to the end of infusion, then at 0.5, 1, 2, 4, 24 and 48 hours after the end of infusion
16300775|NCT00641381|Procedure|autologous hematopoietic stem cell transplantation|Reinfusion of autologous stem cells
16300776|NCT00641381|Procedure|peripheral blood stem cell transplantation|Reinfusion of autologous stem cells
16300777|NCT00641368|Behavioral|R4Power Program|In the 10-lesson online R4Power Program, adolescents will learn cognitive skills (link between thoughts, feelings, and behaviors; thinking traps; challenging negative beliefs) and problem-solving skills (assertiveness; relaxation and distraction; overcoming procrastination; decision-making) in order to cope with stressful situations.
16300778|NCT00641368|Other|Waitlist Control|Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.
16300779|NCT00641355|Procedure|No intervention|No intervention
16300780|NCT00641342|Device|onlay mesh|StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
16300781|NCT00641329|Drug|CLONICEL (clonidine HCl sustained release)|Flexible Dose (0.1 - 0.4 mg)
16300782|NCT00641329|Drug|Placebo|Matching placebo tablets
16300783|NCT00641316|Procedure|AtraumaticTeeth Extraction|Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
16300784|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
16300785|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
16300786|NCT00641316|Procedure|Atraumatic Teeth Extraction/Grafted Extraction Sockets|Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
16300787|NCT00641303|Procedure|acupuncture therapy|Given weekly for 8 sessions
16300788|NCT00641303|Procedure|sham intervention|Given weekly for 8 sessions
16300789|NCT00641290|Device|Vigileo FloTrac Sensor|Comparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output.
16300790|NCT00641264|Drug|Omeprazole|
16300791|NCT00641264|Behavioral|Quality of Life questionnaire|
16300792|NCT00641251|Other|intensive medical management|IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment consistent with standard of care for diabetes and other CVD risk factors.
16300793|NCT00641251|Other|RYGB & IMM|Roux-en-Y gastric bypass Surgery combined with intensive medical management
16300794|NCT00641238|Device|Radiofrequency ablation|Radiofrequency ablation
16300795|NCT00641225|Drug|SBI-087|Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.
16300796|NCT00641212|Drug|Budesonide|
16300797|NCT00641212|Drug|Placebo|
16300798|NCT00641199|Other|Jarro-Dophilus EPS probiotics|Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
16300799|NCT00641186|Drug|sodium oxybate|4.5 to 9.0 grams per night
16300800|NCT00641173|Drug|paroxetine|treatment with SSRI paroxetine
16300801|NCT00641173|Drug|placebo|treatment with placebo
16300802|NCT00641160|Drug|vinorelbine tartrate|Dose Level #1 PO for at least 7 days
16300803|NCT00641160|Drug|vinorelbine tartrate|Dose Level #2 PO for at least 7 days
16300804|NCT00641160|Drug|vinorelbine tartrate|Dose Level #3 PO for at least 7 days
16300805|NCT00641147|Drug|Curcumin|Given PO
16300806|NCT00641147|Other|Laboratory Biomarker Analysis|Correlative studies
16300807|NCT00641147|Other|Placebo|Given PO
16300808|NCT00641134|Other|A: Home-Based exercise after Cardiac Rehabilitation|Home-Based exercise program,after CR, with reinforcement sessions
16300809|NCT00641108|Drug|ADAM SPECT plus Cognitive Therapy|
16300810|NCT00641108|Drug|ADAM SPECT plus No Therapy|
16300811|NCT00641095|Biological|rituximab|concentrate for solution for infusion
16300812|NCT00641095|Drug|Cyclophosphamide|Tablets
16300813|NCT00641095|Drug|Fludarabine|Film coated tablet
16300814|NCT00641082|Drug|Clevudine|30mg for 48 weeks
16300815|NCT00641082|Drug|Adefovir dipivoxil|10mg for 48 weeks
16300816|NCT00641069|Device|Automated load-distributing band device|Blood pressure recording before and after starting up the automated band device
16300817|NCT00641056|Drug|Exenatide Once Weekly|subcutaneous injection, 2.0mcg, once weekly
16300818|NCT00641056|Drug|Insulin Glargine|subcutaneous injection, variable dose, QD
16300819|NCT00641043|Drug|placebo + pioglitazone (30 mg)|placebo + overcapsulated 30 mg tablet, once daily
16300820|NCT00641043|Drug|Linagliptin + pioglitazone (30 mg)|5 mg tablet + overcapsulated 30 mg tablet, once daily
16301160|NCT00638690|Drug|Placebo|Four tablets once daily until disease progression
16300821|NCT00641030|Drug|clofarabine|Administered at the appropriate dose level(dose level one = 30 mg/m2, dose level two and three = 40 mg/m2)on days -9 to day -5 from transplant
16300822|NCT00641030|Drug|melphalan|Administered at the appropriate dose level (dose level one and two = 100 mg/m2, dose level three = 140 mg/m2) on day -4 from transplant
16300823|NCT00641030|Genetic|gene expression analysis|Peripheral blood draw on day -9 and day -4 prior to transplant
16300824|NCT00641030|Genetic|reverse transcriptase-polymerase chain reaction|Peripheral blood draw on day -9 and day -4 prior to transplant
16300825|NCT00641030|Other|flow cytometry|Bone marrow aspirate and biopsy to confirm diagnosis prior to transplant, day -9 pre-transplant, day 30 post-transplant, day 100 post-transplant, 6 months post-transplant, one year post-transplant, then yearly through year 5 post-transplant
16300826|NCT00641030|Other|laboratory biomarker analysis|Peripheral blood draw day -9 or earlier pre-transplant, day 14 post-transplant, day 30 post-transplant, day 60 post-transplant, day 100 post-transplant, 6 months and one year post-transplant.
16300827|NCT00641030|Procedure|allogeneic hematopoietic stem cell transplantation|Infusion of allogeneic hematopoietic stem cells on day 0 of transplant
16300828|NCT00641017|Biological|rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine|Live attenuated Human Parainfluenza Type 1 Virus Vaccine
16300829|NCT00641017|Biological|Placebo|Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
16300830|NCT00641004|Drug|Rebamipide and Esomeprazole|"Rebamipide 100mg TID for 12 weeks
~Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks"
16300831|NCT00640991|Drug|glulisine insulin, glargine insulin|IV infusion of glulisine, SC injection of glargine
16300832|NCT00640978|Drug|RAD001|30 mg orally weekly for 4 weeks
16300833|NCT00640978|Drug|Erlotinib|150 mg by mouth daily for 28 Days
16300834|NCT00640965|Drug|DP-VPA|DP-VPA dose escalation to 900mg, then continued for 8 weeks
16300835|NCT00640965|Drug|DP-VPA Placebo|Matching Placebo to Active, dose escalation, then continued for 8 weeks
16300836|NCT00640952|Drug|acamprosate|333 mg 2 tabs tid
16300837|NCT00640939|Drug|diclofenac sodium|15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
16300838|NCT00640939|Drug|Matching Placebo|Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
16300839|NCT00640926|Drug|Radezolid|300 mg/day, orally for 7-10 days
16300840|NCT00640926|Drug|Radezolid|450 mg/day orally for 7-10 days
16300841|NCT00640926|Drug|Radezolid|900 mg/day orally for 7-10 days
16300842|NCT00640913|Procedure|Reversal of defunctioning stoma|Reversal of defunctioning stoma
16300843|NCT00640900|Behavioral|Usual care|Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.
16300844|NCT00640900|Behavioral|Commercial weight loss program|Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.
16300845|NCT00640887|Drug|rifabutin in combination with efavirenz|"Ia. arm 1a:
~D4T/3TC/EFV(600mg)+INH/Rifabutin(450 mg OD 4 wks switch to 600 mg OD 4 wks);
~Ib. arm 1b:
~D4T/3TC/EFV(600mg)+INH/Rifabutin(600 mg OD 4 wks switch to 450 mg OD 4 wks);"
16300846|NCT00640887|Drug|rifabutin in combination with nevirapine|"IIa. arm 2a:
~D4T/3TC/NVP(200mg)+INH/Rifabutin(300 mg OD 4 wks switch to 450 mg OD 4 wks);
~IIb. arm 2b :
~D4T/3TC/NVP(200mg)+INH/Rifabutin(450 mg OD 4 wks switch to 300 mg OD 4 wks);"
16300847|NCT00640887|Drug|rifabutin in combination with lopinavir/ritonavir|"IIIa. arm 3a :
~D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg TPW 4 wks switch to 150 mg OD 4 wks);
~IIIb. arm 3b:
~D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg OD 4 wks switch to 150 mg TPW 4 wks)."
16300848|NCT00640861|Biological|CpG oligodeoxynucleotide|
16300849|NCT00640861|Biological|HER-2/neu peptide vaccine|
16300850|NCT00640861|Biological|MUC-1 peptide vaccine|
16300851|NCT00640861|Biological|incomplete Freund's adjuvant|
16300852|NCT00640861|Biological|sargramostim|
16300853|NCT00640861|Other|immunoenzyme technique|
16300854|NCT00640861|Other|immunologic technique|
16300855|NCT00640848|Drug|almorexant|1 dose of 400 mg in two treatment sequences
16300856|NCT00640848|Drug|almorexant|1 dose of 200 mg in two treatment sequences
16300857|NCT00640848|Drug|almorexant|1 dose of 100 mg in two treatment sequences
16300858|NCT00640848|Drug|almorexant|1 dose of 50 mg mg in two treatment sequences
16300859|NCT00640848|Drug|almorexant|1 dose of 1000 mg in two treatment sequences
16300860|NCT00640835|Drug|Buprenorphine/naloxone Film Strip|Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
16300861|NCT00640835|Drug|Buprenorphine/naloxone Film Strip|Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route
16300862|NCT00640822|Drug|Calcipotriol plus hydrocortisone ointment vehicle|Once daily application for up to 8 weeks
16300863|NCT00640822|Drug|Tacalcitol Ointment|Once daily application for up to 8 weeks
16300864|NCT00640822|Drug|Calcipotriol plus hydrocortisone ointment|Once daily application for up to 8 weeks
16300865|NCT00640809|Drug|Celecoxib|200 mg oral capsule twice daily for 2 weeks
16300866|NCT00640809|Other|Placebo|Matched placebo for 2 weeks
16300867|NCT00640809|Drug|Ibuprofen plus Omeprazole|ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
16300868|NCT00640796|Procedure|Haploidentical donor derived natural killer cell infusion|Therapeutic cell infusion
16300869|NCT00640796|Drug|Chemotherapy|Cyclophosphamide, Fludarabine, Interleukin-2, Mesna
16300870|NCT00640796|Device|CliniMACS|Cell selection system based on magnetic-activated cell sorting
16300871|NCT00640783|Behavioral|Mediterranean diet|The dietary advice was tailored to each patient on the basis of 3-day food records. The recommended composition of the dietary regimen was as follows: carbohydrates, 50% to 60%; proteins, 15% to 20%; total fat, less than 30%; saturated fat, less than 10%; and cholesterol consumption, less than 300 mg per day. Moreover, patients were advised to consume at least 250 to 300 g of fruits, 125 to 150 g of vegetables, and 25 to 50 g of walnuts per day; in addition, they were also encouraged to consume 400 g of whole grains (legumes, rice, maize, and wheat) daily and to increase their consumption of olive oil.
16300975|NCT00640016|Other|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
16300872|NCT00640783|Behavioral|Control|Patients consuming the control diet were given general oral and written information about healthy food choices at baseline and at subsequent visits but were offered no specific individualized program. However, the general recommendation for macronutrient composition of the diet was similar to that for the intervention group (carbohydrates, 50%-60%; proteins, 15%-20%; and total fat, <30%).
16300873|NCT00640770|Device|balloon angioplasty|balloon angioplasty
16300874|NCT00640770|Device|drug eluting stent|Cypher Select+ Coronary or Infrapopliteal Stent
16300875|NCT00640757|Dietary Supplement|Methionine deficient diet|Hominex with a low protein diet
16300876|NCT00640757|Dietary Supplement|Methionine sufficient diet|Hominex, low protein diet and methionine capsules
16300877|NCT00640744|Drug|Atorvastatin|Atorvastatin 80 mg tablet/day for 3 months
16300878|NCT00640731|Device|OmniWave Endovascular System|Treatment with mechanical thrombolysis/thrombectomy
16300879|NCT00640705|Drug|diclofenac sodium|15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
16300880|NCT00640705|Drug|Matching placebo patch|Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
16300881|NCT00640679|Drug|Abrupt Clopidogrel Interruption|Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly.
16300882|NCT00640679|Drug|Clopidogrel Tapering|Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
16300883|NCT00640666|Behavioral|Exercise Behavior Change|Multidisciplinary
16300884|NCT00640653|Behavioral|Abstinence-only HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use.
16300885|NCT00640653|Behavioral|Safer-sex-only HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.
16300886|NCT00640653|Behavioral|Long comprehensive HIV/STD risk-reduction intervention|Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours).
16300887|NCT00640653|Behavioral|Short comprehensive HIV/STD risk-reduction intervention|Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.
16300888|NCT00640653|Behavioral|Health promotion control intervention|"Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
16300889|NCT00640640|Device|Pascal Dynamic Contour Tonometer|Pascal Dynamic Contour Tonometer is an ocular device that is able to safely measure the intraocular pressure and the ocular pulse amplitude
16300890|NCT00640640|Drug|Ranibizumab|measure the effect of intravitreal 0.5mg/0.05ml ranibizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
16300891|NCT00640640|Drug|Bevacizumab|measure the effect of intravitreal 1.25mg/0.05ml bevacizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
16300892|NCT00640627|Drug|Celecoxib|200 mg oral capsule once daily for 6 weeks
16300893|NCT00640627|Drug|Placebo|Matched oral placebo for 6 weeks
16300894|NCT00640614|Biological|T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens|"Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP
~Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours."
16300895|NCT00640601|Drug|Quetiapine Fumarate Extended- Release|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
16300896|NCT00640588|Drug|Telbivudine|Arm 1: 600 mg/day, oral telbivudina for 24 weeks
16300897|NCT00640588|Drug|oral adefovir|Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
16300898|NCT00640575|Drug|triamcinolone and lidocaine hydrochloride|Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region
16300899|NCT00640575|Drug|triamcinolone and lidocaine hydrochloride|Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region
16300900|NCT00640562|Drug|Quetiapine Extended Release|Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
16300901|NCT00640562|Drug|Risperidone|Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
16300902|NCT00640549|Drug|Atorvastatin|After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the atorvastatin group were treated with atorvastatin 20 mg tablets administered once daily orally for 8 weeks.
16300903|NCT00640549|Drug|Placebo|After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the placebo group were treated with placebo 20 mg tablets administered once daily orally for 8 weeks.
16300904|NCT00640523|Drug|forodesine HCl|2 x 100mg capsules daily
16300905|NCT00640510|Drug|Rapid Acting Intramuscular Olanzapine|10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
16300906|NCT00640510|Drug|Isotonic sodium chloride solution|0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
16300907|NCT00640497|Biological|IT-Combination|The treatment consists of a standard dose of 4 infusions of IT-combination (4 mg/m2), given 48-hours apart over a 4-hour period. The IT-combination is a combination of two immunotoxins. One immunotoxin is a mAb anti-CD3 conjugated to recombinant ricin A chain and the other immunotoxin is a mAb anti-CD7 conjugated to recombinant ricin A chain.
16300908|NCT00640484|Drug|carmoterol (CHF 4226)|"carmoterol (CHF 4226) 2 μg once a day, in the morning
~(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)"
16300909|NCT00640484|Drug|carmoterol (CHF 4226)|"carmoterol (CHF 4226) 4 μg once a day, in the morning
~(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)"
16300910|NCT00640484|Drug|placebo|"placebo once a day, in the morning
~(1 puff of placebo pMDI + 1 puff of placebo pMDI)"
16300911|NCT00640484|Drug|salmeterol|"Salmeterol 50 μg twice daily, in the morning and in the evening
~(1 blister of Serevent Diskus BID)"
16300912|NCT00640471|Biological|cetuximab|cetuximab (Erbitux®) - Initial dose - Day 1 (Week 1): 400 mg/m2 IV over 120 minutes Maintenance Infusions (subsequent weeks): 250 mg/m2 IV over 60 minutes
16300913|NCT00640471|Drug|brivanib alaninate|brivanib (BMS-582664) 800 mg po, QD
16300914|NCT00640458|Drug|Sildenafil 100 mg|
16300915|NCT00640458|Drug|Placebo|
16300916|NCT00640445|Behavioral|Expressive Writing|In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days
16300917|NCT00640445|Behavioral|Control Writing|Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
16300918|NCT00640432|Drug|Diclofenac|75 mg oral capsule twice daily for 7 days
16300919|NCT00640432|Drug|Celecoxib|400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
16300920|NCT00640419|Drug|ABT-089|Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
16300921|NCT00640419|Drug|placebo|Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.
16300922|NCT00640406|Device|Dynamic Renal Stent plus Best Medical Treatment|percutaneous transluminal angioplasty of the kidney artery at index procedure followed by best medical treatment for hypertension secondary to renal artery stenosis according to local standards
16300923|NCT00640406|Drug|Best Medical Treatment|best medical treatment for hypertension secondary to renal artery stenosis according to local standards
16300924|NCT00640393|Drug|Etanercept|Etanercept 50 mg, subcutaneous (SC) injection.
16300925|NCT00640393|Device|nbUVB|
16300926|NCT00640380|Other|Nerve stimulation|CPVB with NS
16300927|NCT00640380|Other|Loss of resistance to air|CPVB with LOR
16300928|NCT00640367|Other|Alteplase IA and/or mechanical thrombolysis|loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis
16300929|NCT00640367|Drug|Alteplase IV|intravenous recombinant tissue plasminogen activator
16300930|NCT00640354|Device|Automated external defibrillator|Residents randomized to this group had an automated external defibrillator available for the simulated cardiac arrest. The automated external defibrillator did not actually discharge energy into the simulated patient
16300931|NCT00640354|Device|Manual defibrillator|Residents randomized to this group had a manual defibrillator available for the simulated cardiac arrest. The defibrillator did not actually discharge energy into the simulated patient.
16300932|NCT00640341|Device|PureVision Contact Lens|contact lens for daily wear
16300933|NCT00640341|Device|Acuvue Oasys Contact Lens|contact lens for daily wear
16300934|NCT00640341|Device|O2Optix Contact lens|contact lens for daily wear
16300935|NCT00640328|Drug|Ofatumumab 100|100mg
16300936|NCT00640328|Drug|Ofatumumab 300|300mg
16300937|NCT00640328|Drug|Ofatumumab 700|700mg
16300938|NCT00640328|Drug|Placebo|matching placebo
16300939|NCT00640315|Drug|Riociguat (Adempas, BAY63-2521) 1.0 mg|1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).
16300940|NCT00640315|Drug|Riociguat (Adempas, BAY63-2521) 2.5 mg|2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).
16300941|NCT00640289|Drug|Fibrogammin P|Prophylaxis treatment
16300942|NCT00640276|Drug|pitavastatin|Pitavastatin 2mg daily once
16300943|NCT00640276|Behavioral|Lifestyle Modification|conducting mainly exercises and diet
16300944|NCT00640263|Drug|lopinavir/ritonavir (LPV/r)|Oral liquid formulation lopinavir/ritonavir(80 mg lopinavir + 20 mg ritonavir/mL); Dosing : 40/10mg twice daily if infant weight is between 2 to 4 kg and 80/20mg twice daily if infant weight is above 4kg The lopinavir/ritonavir will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight.
16300945|NCT00640263|Drug|Lamivudine (3TC)|"Oral liquid solution lamivudine(10 mg/mL). Dosing : 7,5 mg twice daily if if infant weight is between 2 to 4 kg ; 25 mg twice daily if infant weight is between 4 to 8 kg ; 50 mg twice daily if infant weight is above 8kg.
~The lamivudine will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight."
16300946|NCT00640250|Biological|T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens|"Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2
~Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours."
16300947|NCT00640237|Dietary Supplement|Alpha-D3|We will use the vitamin alpha-D3 drops of CTS pharmaceutical firm , that contains 5000 IU in ml. Every patient in the interventional group will receive two dose of 100000 IU (20 ml)vitamin alpha-D3 within a month period.
16300948|NCT00640224|Drug|rosiglitazone|4 mg daily for 6 months
16300949|NCT00640224|Drug|drospirenone/ethinyl estradiol|1 tab (3mg/30mcg) daily for 6 months
16300950|NCT00640198|Drug|memantine|Memantine was titrated in 5-mg weekly increments as recommended,from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24)
16300951|NCT00640198|Behavioral|constraint-induced language therapy (CIAT)|CIAT is an intensive form of language-action therapy for aphasia performed in a small group setting. In a therapeutic game context, participants had to request objects or cards from each other and understand requests made by others. Feedback of communicative success was regularly given, along with guidance, help and reinforcement. Gesturing replacing verbal language was discouraged although gestures accompanying speech were allowed. Difficulty levels were adjusted to the patients´ communicative abilities by choosing language materials and actions and reinforcement was administered taking into account each patient´s level of performance. Communication rules were introduced by shaping and modelling. Each patient received 30 hours of therapy.
16300952|NCT00640198|Drug|memantine|Memantine was titrated in 5-mg weekly increments as recommended, from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24).
16300953|NCT00640198|Drug|placebo|Placebo
16300954|NCT00640185|Drug|ABT-089|Subjects will take up to two 40 mg tablets once daily for 8 weeks.
16300955|NCT00640185|Drug|Placebo|Subjects will take one or two placebos once daily for the duration of the study.
16300956|NCT00640159|Drug|Zelapar|Switch from oral selegiline to Zelapar 1.25 mg QD titrated to 2.5 mg QD
16300957|NCT00640146|Drug|Methylnaltrexone bromide|Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
16300958|NCT00640146|Drug|Placebo|Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
16300959|NCT00640133|Device|Active DBS|In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.
16300960|NCT00640133|Device|Sham DBS|In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
16300961|NCT00640120|Device|WIM-PC™ device|wheeze detection during dynamic bronchial situations in infants
16300962|NCT00640094|Drug|melatonin|Patients will receive a total intravenous melatonin dose of 12 mg + intracoronary melatonin dose of 2 mg. The intravenous dose will be distributed in a volume of 50 ml of a isotonic and sterile solution and administered by intravenous infusion during 60 minutes. The intracoronary dose will be distributed in a volume of 10 ml of a isotonic and sterile solution and administered as a bolus.
16300963|NCT00640081|Biological|cetuximab|
16300964|NCT00640081|Drug|capecitabine|
16300965|NCT00640081|Drug|fluorouracil|
16300966|NCT00640081|Drug|leucovorin calcium|
16300967|NCT00640081|Drug|oxaliplatin|
16300968|NCT00640081|Other|immunohistochemistry staining method|
16300969|NCT00640081|Other|laboratory biomarker analysis|
16300970|NCT00640055|Other|Coordinator|Coordinator (non-physician) assigned cause of death
16300971|NCT00640055|Other|Physician-assigned cause of death|Physician (gold standard) cause of death
16300972|NCT00640042|Drug|morphine sulfate extended release capsules|30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
16300973|NCT00640029|Procedure|Arthrodesis|"posterior,
~anterior,
~circumference approach"
16300974|NCT00640029|Device|Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)|"SYNTHES : PRODISC-C® , PRODISC-L®
~LDR : Mobi-C®, Mobidisc®
~MEDTRONIC : PrestigeLP®, A-Mav®, O-Mav®
~SCIENT'X : DISCOCERV®"
16300976|NCT00640016|Biological|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
16300977|NCT00640016|Biological|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
16300978|NCT00640016|Other|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
16300979|NCT00640003|Drug|Baclofen|Drug given by orally via capsules. Escalation steps in 4-day intervals. Step 1: 5mg QAM. Step 2: 5mg BID. Step 3: 5mg TID. Step 4: 10mg QAM, 5mg BID. Step 5: 10mg BID, 5mg QMid-day. Step 6: 10mg TID. Step 6 will last up to 2 weeks. De-escalation will start from highest dose step and work backwards in 2-day intervals. Complete drug administration of escalating, staying constant at 10mg TID and de-escalating will be done with both drug and placebo.
16300980|NCT00640003|Drug|Placebo|placebo drug
16300981|NCT00639990|Other|PEEP|Application of positive end expiratory pressure
16300982|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
16300983|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
16300984|NCT00639990|Other|PEEP|Application of positive end-expiratory pressure
16300985|NCT00639977|Other|Acupuncture|20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
16300986|NCT00639977|Other|Sham|20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
16300987|NCT00639964|Other|blood tests|3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
16300988|NCT00639964|Other|diet questionnaire|questions about nutrition before and during pregnancy
16300989|NCT00639964|Other|umbilical cord blood collect|collected at the delivery
16300990|NCT00639964|Other|placenta collect|collected at the delivery
16300991|NCT00639951|Biological|A|20 vials up front in a Single Dose of Antivipmyn
16300992|NCT00639951|Biological|Antivipmyn ®|20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
16300993|NCT00639938|Drug|Nevirapine|200 mg Nevirapine tablet
16300994|NCT00639938|Drug|HIV immune globulin solution|5% intravenous HIV immune globulin solution
16300995|NCT00639925|Biological|VEGFR1-1084, VEGFR2-169, and gemcitabine|One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.
16300996|NCT00639912|Drug|sodium chloride|Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
16300997|NCT00639912|Drug|sodium chloride|Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours
16300998|NCT00639912|Drug|sodium bicarbonate|154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
16300999|NCT00639912|Drug|sodium bicarbonate|154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.
16301000|NCT00639899|Procedure|Sclerotherapy|Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
16301001|NCT00639873|Drug|Artesunate|2 or 4 mg/kg/day for 7 days
16301002|NCT00639873|Drug|quinine-doxycycline|quinine-doxycycline for 7 days
16301003|NCT00639860|Device|OSSIX-Plus|resorbable collagen membrane
16301004|NCT00639847|Behavioral|In-home asthma management program (AMP) provided by nurses|The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)
16301005|NCT00639847|Behavioral|In-home asthma management program (AMP) provided by respiratory therapists|The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)
16301006|NCT00639834|Biological|MDX-1342|One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.
16301007|NCT00639808|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
16301008|NCT00639808|Drug|TZP-101|1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
16301009|NCT00639795|Procedure|Thoracic Paravertebral Nerve Block|One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia
16301010|NCT00639795|Procedure|Thoracic Paravertebral Nerve Block|Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia
16301011|NCT00639782|Device|On-X Heart valve replacement|On-X Heart valve replacement
16301012|NCT00639782|Device|SJM Heart valve replacement|SJM Heart valve replacement
16301013|NCT00639769|Drug|cisplatin|Starting dose 30 mg/m2 Dose level -1 20 mg/m2
16301014|NCT00639769|Drug|irinotecan hydrochloride|50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
16301015|NCT00639756|Drug|Allopurinol|Allopurinol 300 mg
16301016|NCT00639756|Drug|Placebo|Placebo given for 2 weeks
16301017|NCT00639743|Drug|placebo ( group B)|placebo ( group B)
16301018|NCT00639743|Drug|tenecteplase (group A)|tenecteplase (group A)
16301019|NCT00639730|Dietary Supplement|modified Atkins diet|High fat, low carbohydrate diet
16301020|NCT00639717|Procedure|stem cell transplant|reduced intensity, matched unrelated donor stem cell transplant
16301021|NCT00639717|Drug|tacrolimus (standard GVHD prophylaxis)|"Tacrolimus(or cyclosporine when necessary)
~Tacrolimus will begin on day -3, IV or oral.
~Target trough level for tacrolimus is 8-12 ng/ml.
~In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant"
16301158|NCT00638703|Biological|Oxalobacter formigenes|NLT (not less than) 10^7 CFU Oxalobacter formigenes twice daily for 24 weeks
16301022|NCT00639717|Drug|mycophenolate (standard GVHD prophylaxis)|Mycophenolate will begin on day 0 at 10 mg/kg/dose (up to 1 gram per dose) every 8 hours orally or intravenously and will continue until day 28.
16301023|NCT00639717|Drug|etanercept|Etanercept will be given at a dose 0.4 mg/kg (actual weight) up to a maximum dose of 25 mg, subcutaneously, twice weekly from day 0 to day 56 (16 doses)
16301024|NCT00639717|Drug|methoxsalen|"Methoxsalen (UVADEX) treatments by Extracorporeal photopheresis (ECP) will be started day +28 post transplant and given weekly.
~On day +70 post transplant ECP frequency will be given every other week.
~On day +100 post transplant ECP will be given monthly until day +180 and stopped."
16301025|NCT00639691|Biological|omalizumab|sc
16301026|NCT00639678|Drug|placebo|40 mg/kg intravenously, double dose (day 0 and 14), Group 3
16301027|NCT00639678|Drug|raxibacumab|40 mg/kg intravenously, double dose (day 0 and 14), Group 1
16301028|NCT00639678|Drug|placebo|40 mg/kg placebo, single dose (day 0), Group 4
16301029|NCT00639678|Drug|raxibacumab|40 mg/kg intravenously, single dose, day 0, Group 2
16301030|NCT00639665|Other|Cocoa|Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.
16301031|NCT00639652|Procedure|3D-histology|The tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained.
16301032|NCT00639652|Procedure|Shave excision|Tumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1).
16301033|NCT00639639|Biological|tetanus toxoid|Given by injection
16301034|NCT00639639|Biological|therapeutic autologous dendritic cells|Given intradermally
16301035|NCT00639639|Biological|therapeutic autologous lymphocytes|Given IV
16301036|NCT00639626|Drug|insulin detemir [rDNA origin] injection|Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
16301037|NCT00639613|Procedure|Double-balloon enteroscopy|Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time. The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon. The procedure is usually done with the use of conscious sedation. The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel. Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated. Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube. The overtube balloon is then deployed, and the enteroscope balloon is deflated. The process is then continued until the entire small bowel is visualized. Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
16301038|NCT00639613|Other|Standard meal test|"Liquid meal consisting of 100 g Ny NAN dissolved in 300 ml water (ca. 5000 kJ) to be ingested over 5 minutes. Blood will be sampled for 4 hours following ingestion. Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations."
16301039|NCT00639600|Procedure|human pancreatic islet transplantation|human pancreatic islet transplantation
16301040|NCT00639587|Drug|Ketotifen|Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
16301041|NCT00639587|Drug|Cetirizine|Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
16301042|NCT00639574|Drug|Néfopam|"There are two groups :
~a group N : néfopam
~a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes."
16301043|NCT00639561|Dietary Supplement|10 g of fibres per day|10 g of fibres per day
16301044|NCT00639561|Dietary Supplement|40 g of fibres per day|40g of fibres per day
16301045|NCT00639522|Drug|Liposomal paclitaxel and capecitabine|Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.
16301046|NCT00639509|Biological|cixutumumab|Given IV
16301047|NCT00639509|Procedure|computed tomography|Undergo contrast-enhanced computed tomography
16301048|NCT00639509|Procedure|contrast-enhanced magnetic resonance imaging|Undergo contrast-enhanced magnetic resonance imaging
16301049|NCT00639496|Drug|n-acetylcysteine|600 mg x 3, for 12 months
16301050|NCT00639496|Drug|placebo|Placebo
16301051|NCT00639483|Drug|Celecoxib|200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
16301052|NCT00639483|Drug|Placebo|Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
16301053|NCT00639470|Other|easy to read fact sheets|easy to read fact sheets with illustrations and without illustrations
16301054|NCT00639457|Drug|Pioglitazone|Oral 30mg/day for 16 weeks
16301055|NCT00639457|Behavioral|Exercise training|Supervised aerobic and resistance exercise training (1.5hrs/day x 3 days/wk) for 16 weeks
16301056|NCT00639444|Dietary Supplement|gluten-free, normocaloric diet from 6 to 12 months|Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
16301057|NCT00639431|Behavioral|direct observation|direct observation of another person's foot moving
16301058|NCT00639431|Behavioral|mental visualization|mentally imagining moving one's phantom foot/feet
16301059|NCT00639418|Biological|Influenza vaccination|This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.
16301159|NCT00638703|Drug|Placebo|placebo
16301060|NCT00639392|Drug|Placebo|Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
16301061|NCT00639392|Drug|Zoledronic Acid|Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.
16301062|NCT00639379|Device|senofilcon A toric|silicone hydrogel toric lens, 2 wk replacement, daily wear
16301063|NCT00639379|Device|alphafilcon A toric|hydrogel toric lens, 2 wk replacement, daily wear
16301064|NCT00639366|Biological|trastuzumab|
16301065|NCT00639366|Drug|chemotherapy|
16301066|NCT00639366|Radiation|radiation therapy|
16301067|NCT00639353|Device|senofilcon A toric soft contact lens|contact lens
16301068|NCT00639353|Device|senofilcon A sphere soft contact lens|contact lens
16301069|NCT00639327|Drug|S-1 + irinotecan|Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
16301070|NCT00639327|Drug|irinotecan|Irinotecan 150mg/m2 iv on day one every two weeks until PD
16301071|NCT00639314|Procedure|pylorus-preserving pancreaticoduodenectomy|pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
16301072|NCT00639314|Procedure|pylorus-resecting pancreaticoduodenectomy|In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.
16301073|NCT00639301|Behavioral|Questionnaires|The survey will be administered by mail or telephone interview, based upon the participant preference. The survey has been adapted from the 2008 questionnaire being administered through the CCSS (11); it has been supplemented with questions addressing areas of interest specific to the retinoblastoma survivor population (eg, validated instruments that assess visual impairment).
16301074|NCT00639288|Other|modified CPT-C|modified CPT-C
16301075|NCT00639262|Drug|Sorafenib|Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)
16301076|NCT00639262|Drug|Temozolomide|For Cohort 2 - Gliomas only.
16301077|NCT00639262|Radiation|Radiotherapy|Radiation Therapy (XRT)
16301078|NCT00639249|Drug|placebo|Oral administration
16301079|NCT00639249|Drug|SA4503 Low|Oral administration
16301080|NCT00639249|Drug|SA4503 High|Oral administration
16301081|NCT00639236|Other|hypertonic saline|inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.
16301082|NCT00639223|Dietary Supplement|Red Yeast Rice|Four 600mg capsules twice daily for 12 weeks
16301083|NCT00639223|Drug|Pravastatin|One 20mg capsule twice daily for 12 weeks
16301084|NCT00639223|Behavioral|Lifestyle modification program|Weekly sessions each lasting 3 1/2 hours for 12 weeks
16301085|NCT00639210|Other|supervised training|Design: supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects. The training is guided by an experienced physical therapist.Content: The supervised training of the exercise group consists of two different classes alternating at four week periods; step aerobics class and circuit training class. The 60-minute aerobics and circuit training classes also include warming-up and cooling-down periods both lasting 10-15 minutes.
16301086|NCT00639197|Procedure|To tunnel|Using the standard Seldinger technique and under the guidance of ultrasound, the catheter will pass through a 3-5cm subcutaneous tunnel before it is eventually secured to reside at the internal jugular vein.
16301087|NCT00639197|Procedure|Standard (not to tunnel)|Using the standard Seldinger technique and under the guidance of ultrasound, the catheter is secured to reside at the internal jugular vein, without a subcutaneous tunnel.
16301088|NCT00639184|Other|Early intervention counseling|Bi-monthly home visits by counselor
16301089|NCT00639184|Other|Health education counseling|World Health Education health education counseling program at home visits,twice per month
16301090|NCT00639158|Drug|ABT-335|135 mg capsule, daily, 12 weeks
16301091|NCT00639158|Drug|placebo|placebo capsule, daily, 12 weeks
16301092|NCT00639158|Drug|atorvastatin|40 mg, tablet, daily, 12 weeks
16301093|NCT00639158|Drug|ezetimibe|10 mg capsule, daily, 12 weeks
16301094|NCT00639119|Drug|Ropinirole|8 + 8 weeks cross-over placebo controlled
16301095|NCT00639106|Procedure|Alloderm, Questionnaires|All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.
16301096|NCT00639106|Procedure|Without ALLODERM, Questionnaires|A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
16301097|NCT00639093|Behavioral|psychoeducational / motivational combined with crushing|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
16301098|NCT00639093|Behavioral|psychoeducational / motivational combined with control|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).
~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
16301099|NCT00639080|Other|Stop lipid lowering therapy (statin)|Subjects will only be included in the study and thus asked to stop the statin if they are taking less than or equal to 10 mg of lipitor or an equivalent of another statin.
16301100|NCT00639067|Device|Breath Collection Apparatus|Breath collected and analyzed for markers of lung cancer.
16301101|NCT00639054|Procedure|Bone marrow examination|7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples.
16301102|NCT00639054|Procedure|Blood samples|24 ml of cubital vein blood drawn in addition to diagnostic samples.
16301103|NCT00639041|Dietary Supplement|n-3 LC-PUFA|n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
16301104|NCT00639041|Dietary Supplement|Placebo|dairy products without special oils
16301105|NCT00639028|Other|Ankle echography|Ankle echography
16301106|NCT00639028|Other|Ankle echography + stress radiography|Ankle echography + stress radiography
16301107|NCT00639028|Other|stress radiography|ankle stress radiography
16301202|NCT00638274|Procedure|Air|3 mls used for identifying epidural space
16301108|NCT00639015|Drug|Phenylephrine|Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
16301109|NCT00639015|Drug|Norepinephrine|Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
16301110|NCT00639002|Drug|Ruxolitinib 25 mg|Ruxolitinib was supplied as 5 and 25 mg tablets.
16301111|NCT00639002|Drug|Dexamethasone 40 mg|Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
16301112|NCT00638989|Biological|CAT-354 150 mg (intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
16301113|NCT00638989|Biological|CAT-354 150 mg (subcutaneous)|A single dose of CAT-354 150 mg injection subcutaneously on Day 0.
16301114|NCT00638989|Biological|CAT-354 300 mg (subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
16301115|NCT00638976|Drug|eptifibatide|Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
16301116|NCT00638976|Drug|placebo|Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of DES >33 mm in length in the same coronary vessel, to IV placebo or IV eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure
16301117|NCT00638963|Drug|temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
16301118|NCT00638950|Dietary Supplement|n-3 LC-PUFA|Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils. The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA.
16301119|NCT00638950|Dietary Supplement|Placebo|The placebo products were commercial dairy products with comparable fat contents.
16301120|NCT00638937|Drug|saracatinib|Given PO
16301121|NCT00638924|Other|Shuttle walk test|the test requires patients to walk at a gradually increasing speed, up and down a 10 m course identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.
16301122|NCT00638898|Drug|busulfan|Given IV
16301123|NCT00638898|Drug|melphalan|Given IV
16301124|NCT00638898|Drug|topotecan hydrochloride|Given IV
16301125|NCT00638898|Other|laboratory biomarker analysis|Correlative studies
16301126|NCT00638898|Biological|filgrastim|Given IV or subcutaneously
16301127|NCT00638898|Procedure|autologous hematopoietic stem cell transplantation|Undergo transplantation
16301128|NCT00638898|Other|pharmacological study|Correlative studies
16301129|NCT00638898|Procedure|autologous bone marrow transplantation|Undergo transplantation
16301130|NCT00638872|Drug|Polydeoxyribonucleotide|3 times a week perilesional or intramuscular injections
16301131|NCT00638872|Other|0.9% NaCl|same as PDRN
16301132|NCT00638859|Drug|Telithromycin (HMR3647)|
16301133|NCT00638846|Device|senofilcon A toric|silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
16301134|NCT00638846|Device|balafilcon A toric|silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
16301135|NCT00638833|Drug|Memantine|Memantine 30 mg/day (20-10-0)
16301136|NCT00638833|Drug|Placebo|Placebo pills
16301137|NCT00638820|Procedure|Stem Cell or Umbilical Cord Blood Transplantation|Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42
16301138|NCT00638820|Drug|Campath, Busulfan, Clofarabine|"12 Campath-1H 0.3 mg/kg intravenously (IV) over 2 hours
~11 Campath-1H 0.3 mg/kg intravenously over 2 hours
~10 Campath-1H 0.3 mg/kg intravenously over 2 hours
~9 Busulfan <12 kg: 2.2 mg/kg/dose IV every 12 hours >12 kg: 1.6 mg/kg/dose IV every 12 hours
~8 Busulfan <12 kg: 2.2 mg/kg/dose IV every 12 hours >12 kg: 1.6 mg/kg/dose IV every 12 hours
~7 Rest
~6 Clofarabine 40 mg/m2 intravenously over 2 hours
~5 Clofarabine 40 mg/m2 intravenously over 2 hours
~4 Clofarabine 40 mg/m2 intravenously over 2 hours
~3 Clofarabine 40 mg/m2 intravenously over 2 hours
~2 Clofarabine 40 mg/m2 intravenously over 2 hours"
16301139|NCT00638820|Procedure|Total Lymphoid Irradiation|Dose 500 cGy via anteroposterior (AP) and posteroanterior (PA) fields (250 cGy AP and 250 cGy PA).
16301140|NCT00638807|Drug|Celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
16301141|NCT00638807|Other|Placebo|Matched oral placebo for 6 weeks
16301142|NCT00638794|Device|Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)|PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System
16301143|NCT00638781|Drug|Desmoteplase|Desmoteplase 62.5 µg/kg BW
16301144|NCT00638781|Drug|Desmoteplase|Desmoteplase 90 µg/kg BW
16301145|NCT00638781|Drug|Desmoteplase|Desmoteplase 125 µg/kg BW
16301146|NCT00638781|Drug|Placebo|Placebo
16301147|NCT00638768|Other|Physiotherapy|10 weekly individual sessions with the therapist each lasting approximately 45 minutes. Techniques included postural taping, massage, mobilisation, exercises. The patients also performed home exercises
16301148|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
16301149|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
16301150|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
16301151|NCT00638755|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
16301152|NCT00638742|Drug|latanoprost|latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.
16301153|NCT00638729|Drug|midazolam|midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
16301154|NCT00638729|Drug|clonidine|pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
16301155|NCT00638729|Drug|placebo|inert tablet p.o., 60-90 min prior to estimated induction time
16301156|NCT00638716|Drug|CJC-1134-PC|1.5 or 2.0 mg CJC-1134-PC
16301157|NCT00638716|Drug|Placebo|Placebo
16301161|NCT00638690|Drug|Abiraterone acetate|Four 250-mg tablets once daily until disease progression
16301162|NCT00638690|Drug|Prednisone/prednisolone|5 mg twice daily until disease progression
16301163|NCT00638677|Dietary Supplement|Sorbitol|Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
16301164|NCT00638677|Dietary Supplement|Xylitol + BB12|Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
16301165|NCT00638677|Dietary Supplement|Xylitol|Xylitol+BB 12 delivery with a pacifier max until 2 years
16301166|NCT00638651|Device|1064 nm Nd:YAG laser|The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy
16301167|NCT00638651|Drug|Imiquimod, 5% cream|2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
16301168|NCT00638638|Drug|Abciximab|"Abciximab: 0.25 mg/Kg bolus
~Abciximab placebo bolus
~Abciximab infusion 10 µg/Kg/min"
16301169|NCT00638638|Drug|Abciximab placebo|"Abciximab placebo Bolus
~Abciximab: 0.25 mg/Kg bolus
~Abciximab infusion 10 µg/Kg/min"
16301170|NCT00638612|Biological|AdV-tk|Four dose levels of AdV-tk with a fixed dose level of valacyclovir are evaluated independently in the two arms of the study due to differences in the concomitant standard of care treatments. The first AdV-tk course is given prior to surgery or radiation by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery in Arm A or same as the first injection in Arm B again followed by 14 days of valacyclovir. The AdV-tk dose levels are: Level 1= 3x10e10 vector particles (vp), Level 2= 1x10e11 vp, Level 3= 3x10e11 vp, Level 4= 1x10e12 vp
16301171|NCT00638612|Drug|Valacyclovir|Valacyclovir caplets at a dose of 2 grams orally three times per day is administered for 14 days starting 1-3 days after each of the two AdV-tk injections in both arms.
16301172|NCT00638599|Device|LMA®|LMA® is placed after anesthesia induction and removed after the operation
16301173|NCT00638599|Device|Endotracheal tube|Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation
16301174|NCT00638560|Dietary Supplement|Vitamin C, Vitamin E|Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily
16301175|NCT00638560|Dietary Supplement|Antioxidant treatment|no treatment
16301176|NCT00638547|Drug|IRT Laronidase|"Laronidase belongs to a class of drugs called enzyme replacement therapies or ERT that provides people with sufficient quantities of an important enzyme that they cannot create on their own. The main ingredient in laronidase is a protein that is identical to a naturally occurring form of the human enzyme alpha-L-iduronidase. Laronidase replaces the missing enzyme alpha-L-iduronidase and restores sufficient enzyme activity to break down GAG buildup.
~Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture"
16301177|NCT00638534|Drug|Telithromycin (HMR3647)|
16301178|NCT00638508|Drug|Ketorolac|Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
16301179|NCT00638508|Drug|Ketorolac and Ropivacaine|Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
16301180|NCT00638495|Drug|Nalfurafine Hydrochloride (TRK-820)|TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
16301181|NCT00638495|Drug|Placebo|Placebo is to be administered orally once daily, after supper in principle, for 28 days.
16301182|NCT00638482|Drug|Hydrochlorothiazide|Hydrochlorothiazide
16301183|NCT00638469|Radiation|UVB-311nm|UVB-311nm radiation given 3 times a week to one randomized body half
16301184|NCT00638469|Other|No treatment|no UV exposure
16301185|NCT00638456|Drug|Budesonide plus Prevacid|Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
16301186|NCT00638456|Drug|placebo plus Prevacid|Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
16301187|NCT00638443|Drug|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
16301188|NCT00638443|Drug|Diphenhydramine|diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
16301189|NCT00638417|Behavioral|Maximal strength training|maximal dynamic strength training from 1 week after the operation, 5 training bouts a week for 4 weeks. The regimen consisted of 2 exercises, leg press and hip abduction, that included 4 series of 5RM involving the operated leg only. 5RM corresponds to approximately 85% of 1RM. When the patients managed to perform 6RM, the load was increased by 5kg. The series were separated by resting periods of 2 minutes.
16301190|NCT00638417|Behavioral|conventional rehabilitation|conventional rehabilitation program: inpatient treatment in a rehabilitation center. Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed. Each session lasted 1 hour and was performed 5 days a week for 4 weeks.
16301191|NCT00638391|Drug|Anastrozole|
16301192|NCT00638378|Drug|Ruxolitinib|Ruxolitinib 25 mg tablets taken with water twice a day.
16301193|NCT00638365|Biological|KB001|Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
16301194|NCT00638365|Other|Placebo|Placebo single-dose administered intravenously
16301195|NCT00638326|Drug|clopidogrel|150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
16301196|NCT00638326|Drug|clopidogrel plus placebo|75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year
16301197|NCT00638313|Biological|Placebo|Subjects will be given either Placebo or PF-04603629.
16301198|NCT00638313|Biological|PF-04603629|Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
16301199|NCT00638300|Device|large pore (FX80) compared to small pore dialyzer (F8HPS)|Effect of pore size
16301200|NCT00638300|Other|Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L|Effect of dialysate bicarbonate concentration
16301201|NCT00638300|Other|Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L|Effect of dialysate calcium concentration
16301203|NCT00638274|Procedure|Saline|3 mls of saline used to identify epidural space
16301204|NCT00638261|Radiation|UVB-311nm|UVB-311nm radiation given 3 times a week to one randomized body-half
16301205|NCT00638248|Drug|Desmoteplase|Desmoteplase 90µg/kg BW i.v. bolus
16301206|NCT00638248|Drug|Desmoteplase|Desmoteplase 125 µg/kg BW i.v. bolus
16301207|NCT00638248|Drug|Placebo|Placebo i.v. bolus
16301208|NCT00638235|Device|AMS Apogee™ with IntePro|Mesh implant for posterior wall pelvic organ prolapse
16301209|NCT00638235|Device|AMS Apogee™ with Intexen LP|Graft implant for posterior wall pelvic organ prolapse
16301210|NCT00638235|Device|AMS Perigee™ with IntePro|Mesh implant for anterior wall pelvic organ prolapse
16301211|NCT00638235|Device|AMS Perigee™ with IntePro Lite|Mesh implant for anterior wall pelvic organ prolapse
16301212|NCT00638235|Device|AMS Apogee™ with IntePro Lite|Mesh implant for posterior wall pelvic organ prolapse
16301213|NCT00638235|Device|AMS Elevate™ Apical & Posteiror with IntePro Lite|Mesh implant for apical and posterior wall pelvic organ prolapse
16301214|NCT00638235|Device|AMS Elevate™ Apical & Posteiror with IntXen LP|Graft implant for apical and posterior wall pelvic organ prolapse
16301215|NCT00638235|Device|AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)|Mesh implant for anteiror and apical wall pelvic organ prolapse
16301216|NCT00638235|Device|AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)|Mesh implant for anteiror and apical wall pelvic organ prolapse
16301217|NCT00638222|Other|Carvedilol and Placebo|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.
16301218|NCT00638209|Drug|Human insulin|
16301219|NCT00638209|Drug|Saline|
16301220|NCT00638196|Drug|Linoleic Acid/Oleic Acid|Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid
16301221|NCT00638170|Biological|Cranberry juice|5 ml/kg up to 300 ml, 1-2 doses daily for six months
16301222|NCT00638170|Biological|Placebo juice|5 ml/kg up to 300 ml, 1-2 doses daily for six months
16301223|NCT00638157|Drug|daptomycin|Intravenous (i.v.) 6 mg/kg q24h
16301224|NCT00638157|Drug|daptomycin and gentamicin|i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin
16301225|NCT00638131|Drug|bosentan|62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
16301226|NCT00638118|Drug|Fexofenadine|
16301227|NCT00638092|Drug|sodium iodide|sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
16301228|NCT00638092|Drug|Sodium Chloride|Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
16301229|NCT00638079|Drug|Megestrol acetate oral suspension 625 mg/5 mL|Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
16301230|NCT00638079|Drug|Megestrol acetate oral suspension 625 mg/5 mL|Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
16301231|NCT00638066|Drug|botulinum toxin|500 units of botulinum toxin for the second arm
16301232|NCT00638066|Drug|botulinum toxin A|250 units of botulinum toxin A once
16301233|NCT00638053|Genetic|somatropin|Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months
16301234|NCT00638027|Drug|placebo|matched tablets bid
16301235|NCT00638027|Drug|memantine|10 mg bid
16301236|NCT00638014|Device|Rapid Sternal Closure System|Sternal talons will be used and supplemented with wires
16301237|NCT00638014|Device|Conventional wire closure|Conventional wire closure of sternum
16301238|NCT00638001|Device|custom-molded insoles and custom-molded shoes|"custom-made insoles in PELITE foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy
~custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy"
16301239|NCT00637988|Drug|Esomeprazole|40mg twice daily
16301240|NCT00637988|Drug|Aspirin|
16301241|NCT00637988|Drug|Rofecoxib|25mg once daily
16301242|NCT00637975|Drug|oxycodone|"Arm A - 20 mg/day
~Arm B - increasing dose startnig at 20 mg/day
~For 15 days or until unacceptable toxicity develops."
16301243|NCT00637975|Drug|pregabalin|"Arm A - pregabalin at increasing dose starting from 50 mg/day
~Arm B - pregabalin 50 mg/day
~For 15 days or until unacceptable toxicity develops."
16301244|NCT00637962|Biological|HIV glycoprotein CN54gp140 (vaccine)|vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle
16301245|NCT00637962|Biological|Carbopol 974|vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle
16301246|NCT00637949|Device|lumiracoxib|400 mg once daily, oral over 6 weeks
16301247|NCT00637949|Drug|rofecoxib|25 mg, oral, daily over 6 weeks
16301248|NCT00637936|Drug|Oxygen|Inspiratory fraction during anaesthesia
16301249|NCT00637923|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
16301250|NCT00637923|Drug|Placebo|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
16301251|NCT00637923|Biological|Peginterferon alfa-2a|One weekly injection of 180µg of peginterferon α-2a for 48 weeks.
16301252|NCT00637923|Drug|Ribavirin|Weight-based ribavirin for 48 weeks.
16301253|NCT00637910|Drug|Erlotinib|Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
16301254|NCT00637910|Drug|Docetaxel|Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
16301255|NCT00637897|Drug|docetaxel|
16301256|NCT00637897|Drug|ixabepilone|
16301257|NCT00637897|Drug|paclitaxel|
16301258|NCT00637897|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16301259|NCT00637897|Drug|paricalcitol|
16301260|NCT00637884|Drug|Fexofenadine HCl|
16301261|NCT00637871|Drug|Casodex|150mg once daily
16301262|NCT00637871|Drug|Tamoxifen|
16301263|NCT00637858|Dietary Supplement|Lyc-O-Mato 5mg|Daily Lyc-O-Mato 5mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
16301264|NCT00637858|Dietary Supplement|Lyc-O-Mato 15mg|Daily Lyc-O-Mato 15mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
16301265|NCT00637858|Dietary Supplement|Lyc-O-Mato 30mg|Daily Lyc-O-Mato 30mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule
16301266|NCT00637858|Dietary Supplement|Lycopene capsules (non Lyc-o-mato) 15 mg|Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).
16301267|NCT00637858|Other|Placebo|Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
16301268|NCT00637845|Drug|Esomeprazole Magnesium|40mg once daily
16301269|NCT00637845|Drug|Lansoprazole|30mg twice daily
16301270|NCT00637832|Biological|rituximab|
16301271|NCT00637832|Drug|cyclophosphamide|
16301272|NCT00637832|Drug|doxorubicin hydrochloride|
16301273|NCT00637832|Drug|prednisolone|
16301274|NCT00637832|Drug|vincristine sulfate|
16301275|NCT00637832|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16301276|NCT00637819|Drug|Leflunomide|A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo
16301277|NCT00637806|Drug|Megestrol acetate concentrated suspension 110 mg/mL|Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
16301278|NCT00637806|Drug|Megestrol acetate concentrated suspension 60 mg/mL|Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
16301279|NCT00637806|Drug|Placebo|Placebo oral suspension, 5 mL once daily
16301280|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
16301281|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
16301282|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
16301283|NCT00637793|Drug|NGX267|2 capsules in the am of each treatment period
16301284|NCT00637780|Drug|Sulfasalazine|Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
16301285|NCT00637767|Drug|melphalan|
16301286|NCT00637767|Procedure|autologous hematopoietic stem cell transplantation|
16301287|NCT00637767|Radiation|yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183|
16301288|NCT00637741|Device|Everflex 200|
16301289|NCT00637728|Drug|Megestrol acetate concentrated suspension 110 mg/mL|Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
16301290|NCT00637728|Drug|Placebo|Placebo oral suspension, 5 mL once daily
16301291|NCT00637715|Drug|Alfuzosin|
16301292|NCT00637702|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|single dose and multiple dose, escalating
16301293|NCT00637676|Procedure|VATS, Talc-Pleurodesis, tunneled pleural drainage|poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
16301294|NCT00637676|Procedure|VATS, Talc-pleurodesis|poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
16301295|NCT00637663|Drug|Entecavir|entecavir 0.5 mg QD
16301296|NCT00637663|Drug|Lamivudine|lamivudine 100 mg QD
16301297|NCT00637650|Procedure|Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments|
16301298|NCT00637650|Procedure|Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment|
16301299|NCT00637637|Drug|indinavir sulfate|
16301300|NCT00637637|Drug|ritonavir|
16301301|NCT00637637|Radiation|radiation therapy|
16301302|NCT00637624|Drug|N-Acetylcysteine|N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg
16301303|NCT00637624|Drug|Placebo|Placebo once every 3 weeks intravenous saline fluid
16301304|NCT00637611|Drug|Fexofenadine HCl|
16301305|NCT00637598|Radiation|Mammography and tomosynthesis imaging|All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
16301306|NCT00637585|Drug|Fexofenadine|
16301307|NCT00637572|Drug|Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL|Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
16301308|NCT00637572|Drug|Megestrol acetate oral suspension 40 mg/mL|Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
16301309|NCT00637559|Drug|Esomeprazole Magnesium|
16301310|NCT00637546|Other|Physiotherapy|Gait and Balance training based on recommendations of Robertson et al. and Page et al. (different balance control exercises; progression in consecutive stages: Sensimotor training, a static phase, a dynamic phase combined with functional tasks. The treatment takes place twice a week over 12 weeks. Patients were encouraged to perform specific home exercises.
16301311|NCT00637533|Procedure|Lumbar sympathetic block with Botulinum Toxin type A|
16301346|NCT00637299|Other|Active osteopathic treatment (OMT+PR): Active Comparator|The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).
16301312|NCT00637507|Other|High-frequency Oscillation and Tracheal Gas Insufflation|Patients will receive daily sessions of High-frequency Oscillation and Tracheal Gas Insufflation (HFO-TGI), which will last at least 6 hours. These sessions will comprise a recruitment period of at least 90 min, a stabilization period of at least 4 hours, and a weaning period of at least 60 min. The HFO-TGI strategy will be aimed at initially maximizing PaO2/FiO2 without causing hemodynamic compromise (e.g., >10% reduction in cardiac output/index), and subsequently maintaining PaO2/FiO2 >150 mm Hg, while gradually reducing mPaw to 4-6 cm H2O below its initial setting. The weaning from TGI and HFO will be according to the reversal of the oxygenation criterion that mandated their use (see also Detailed Description).
16301313|NCT00637494|Drug|mifepristone|1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
16301314|NCT00637494|Drug|placebo|Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
16301315|NCT00637481|Drug|atorvastatin calcium|Given orally
16301316|NCT00637481|Other|laboratory biomarker analysis|Correlative studies
16301317|NCT00637468|Drug|Intravenous injection of heparin|
16301318|NCT00637468|Drug|Intravenous injection of acetazolamide|
16301319|NCT00637468|Procedure|Local intra-arterial fibrinolysis|
16301320|NCT00637468|Procedure|Globe massage|
16301321|NCT00637468|Drug|Topical use of beta-blocker|
16301322|NCT00637468|Drug|Isovolaemic haemodilution|
16301323|NCT00637468|Drug|Acetylsalicylic acid|
16301324|NCT00637455|Drug|fexofenadine HCl|
16301325|NCT00637442|Drug|Reminyl retard|retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg
16301326|NCT00637416|Drug|Lansoprazole|Lansoprazole 30 mg taken by mouth daily for 3 months
16301327|NCT00637416|Other|Placebo|placebo taken by mouth daily for 3 months
16301328|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with normal renal function (CLcr >80 mL/min)
16301329|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with mild renal impairment (CLcr 50 - 80 mL/min)
16301330|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with moderate renal impairment (CLcr 30 - <50 mL/min)
16301331|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with severe renal impairment (CLcr <30 mL/min and not on hemodialysis)
16301332|NCT00637403|Drug|Megestrol acetate concentrated suspension 125 mg/mL|Megestrol acetate concentrated suspension (125 mg/mL) administered orally as 2 single doses of 300 mg (2.4 mL x 125 mg/mL) each in subjects with end stage renal disease undergoing hemodialysis. Washout period of 21 days between each dose
16301333|NCT00637390|Drug|Alemtuzumab|will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks
16301334|NCT00637377|Drug|Ranibizumab|Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16301335|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16301336|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16301337|NCT00637377|Biological|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16301338|NCT00637364|Procedure|High intensity focused ultrasound, HIFU|"The FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction).
~The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue."
16301339|NCT00637351|Procedure|Blood sample|One blood sample will be collected at the time of screening for subjects
16301340|NCT00637351|Procedure|Urine sample|One urine sample will be collected at the time of screening for subjects
16301341|NCT00637338|Biological|PF-04603629|Subjects will be given either PF-04603629 or Placebo in a blinded fashion. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
16301342|NCT00637338|Biological|Placebo|Subjects will be given either PF-04603629 or Placebo in a blinded fashion during the study. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
16301343|NCT00637325|Drug|trastuzumab|In the maintenance study trastuzumab will be administrated once every 3 weeks at the dose of 6 mg/kg by intravenous infusion over 90 minutes until progression of disease. In the 2nd line study, to accomplish the schedule of concomitant second line chemotherapy, trastuzumab will be given on a weekly (2 mg/kg) or a 3-weekly (6 mg/kg).
16301344|NCT00637312|Device|Cervical Artificial Disc (Advent™ Cervical Disc)|Advent™ Cervical Disc
16301345|NCT00637312|Device|Hallmark™ Anterior Cervical Plate System|Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)
16301347|NCT00637299|Other|sham osteopathic treatment (SOT+PR)|Only soft manipulation was performed
16301348|NCT00637286|Drug|Zolmitriptan|5mg Nasal Spray
16301349|NCT00637273|Drug|exenatide once weekly|subcutaneous injection, 2.0mg, once a week
16301350|NCT00637273|Drug|sitagliptin|oral tablet, 100mg, once a day
16301351|NCT00637273|Drug|pioglitazone|oral tablet, 45mg, once a day
16301352|NCT00637273|Drug|placebo tablet|oral tablet, once a day
16301353|NCT00637273|Drug|placebo once weekly|subcutaneous injection, once a week
16301354|NCT00637260|Device|Motor cortex stimulation on.|The parameters of stimulation will be: contact 0 cathode, contact 3anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5Volts. The stimulator will be switched on, continuously.
16301355|NCT00637260|Device|motor cortex stimulation off|The parameters of stimulation will be: contact 0 cathode, contact 3 anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5 volts. The stimulator will be switched off.
16301356|NCT00637247|Drug|imexon in combination with gemcitabine|875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
16301357|NCT00637247|Drug|imexon placebo + gemcitabine|imexon placebo IV + 1000 mg/m^2 gemcitabine IV
16301358|NCT00637234|Drug|Oxcarbazepine|Oxcarbazepine (OXC), 300 mg tablets, up to 600 mg three times daily
16301359|NCT00637234|Drug|Placebo|Placebo, 300 mg tablets, up to 600 mg three times daily
16301360|NCT00637221|Drug|NPL-2009|Single doses of either 50mg, 100 mg or 150 mg NPL-2009
16301361|NCT00637208|Procedure|venographic occlusion of spermatic veins|Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.
16301362|NCT00637195|Biological|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)|Intramuscular administration, 3 doses.
16301363|NCT00637195|Biological|Engerix™|Intramuscular administration, 4 doses.
16301364|NCT00637182|Drug|Anastrozole|
16301365|NCT00637169|Other|Titration of oxygen therapy|Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
16301366|NCT00637156|Device|PRESTIGE LP device at two adjacent levels|PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
16301367|NCT00637156|Device|Bi-level fusion with ATLANTIS Cervical Plate System|Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
16301368|NCT00637143|Drug|Tacrolimus|Oral
16301369|NCT00637143|Drug|Cyclosporine|Oral
16301370|NCT00637130|Drug|Travoprost ophthalmic solution, 0.0008%|
16301371|NCT00637130|Drug|Travoprost ophthalmic solution, 0.001%|
16301372|NCT00637130|Drug|Travoprost ophthalmic solution, 0.0012%|
16301373|NCT00637130|Drug|TRAVATAN|
16301374|NCT00637130|Other|Vehicle|
16301375|NCT00637117|Biological|Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS|Day 1 and Day 2: 2 Gy Radiation on Day 1 and Day 2 to tumor site. Day 4, 8, 11, 18: 0.5mL injection of Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS.
16301376|NCT00637104|Device|Mar-Tyn TiN coated Co-Cr Numen stent implant|Implant of the Mar-tyn TiN coated stent
16301377|NCT00637104|Device|Vision Co-Cr stent implant|Implant of the Vision stent
16301378|NCT00637091|Drug|Cetuximab, irinotecan|cetuximab, irinotecan
16301379|NCT00637078|Other|Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide|initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination
16301380|NCT00637065|Drug|Bosentan|Bosentan tablets - 62.5mg bd for first 4 weeks, then 125mg bd if tolerated until trial completion.
16301381|NCT00637065|Drug|Placebo|Placebo tables - identical to active drug but without the active ingredient -
16301382|NCT00637052|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
16301383|NCT00637039|Drug|AZD8931|Tolerability and Pharmacokinetics of AZD8931 in Patients with Advanced Solid Malignancies.
16301384|NCT00637026|Drug|Gefitinib|Iressa
16301385|NCT00637013|Procedure|Acromioplasty|Arthroscopic or open acromioplasty
16301386|NCT00637013|Procedure|Physiotherapy|Physiotherapy according to a standardized protocol
16301387|NCT00637000|Drug|Buprenorphine soluble film|Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.
16301388|NCT00637000|Drug|Buprenorphine/naloxone film strip|Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.
16301389|NCT00637000|Drug|Placebo|Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.
16301390|NCT00636987|Device|Biocor and Biocor Supra valves|Replacement for a diseased, damaged, malformed aortic or mitral heart valve
16301391|NCT00636974|Procedure|Combined spinal epidural anaesthesia|
16301392|NCT00636961|Drug|Indacaterol 300μg|300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device
16301393|NCT00636961|Drug|Placebo|Matching placebo devices and hard gelatin capsules
16301394|NCT00636935|Drug|Antibiotics only|Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
16301395|NCT00636935|Drug|Antibiotics + Corticosteroids|Prednisone 40mg orally twice daily for 11 days, followed by 40mg once daily for 5 days, followed by 20mg once daily for 5 days and antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone).
16301396|NCT00636935|Drug|Corticosteroids + antibiotics|Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
16301397|NCT00636922|Drug|RAD001(Everolimus)|In this study, 5-azacitidine will be administered sc for 7 doses over 9 days in a 28 day cycle. Everolimus will be administered orally with the first dose starting on day 5 (first Friday) of each cycle and continued until day 21 of each cycle. Patients will be treated with combined azacitidine + Everolimus for a minimum of 6 cycles and until at least 2 cycles after documentation of CR. Upon cessation of azacitidine, the patient will be permitted to take Everolimus maintenance therapy until progression at the investigator's discretion.
16301398|NCT00636909|Drug|Cyclophosphamide|preparative cytoreduction
16301399|NCT00636909|Drug|fludarabine|preparative cytoreduction
16301400|NCT00636909|Drug|cyclosporine|immunosuppressive therapy
16301401|NCT00636909|Drug|methotrexate|immunosuppressive therapy
16301402|NCT00636909|Biological|G-CSF|foster engraftment
16301403|NCT00636896|Drug|Olanzapine plus modafinil|Olanzapine 10 mg/d plus modafinil 200 mg/d
16301404|NCT00636896|Drug|Olanzapine plus placebo|Olanzapine 10 mg/d plus placebo
16301405|NCT00636883|Drug|Gemcitabine|GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1, Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each two weeks is a cycle.If at end of 12 cycles response continues, will administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib maintenance therapy.
16301406|NCT00636870|Drug|Fexofenadine|
16301407|NCT00636857|Procedure|Fluid administration|Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
16301408|NCT00636857|Procedure|Perioperative fluid management based on Lean Body Mass|Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
16301409|NCT00636831|Drug|Antibiotic: cefazolin Sodium|1g continuous IV at 30 minutes before starting operation
16301410|NCT00636818|Drug|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
16301411|NCT00636805|Drug|Palonosetron (Aloxi) and Dexamethasone|single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
16301412|NCT00636792|Drug|VELCADE|VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
16301413|NCT00636792|Drug|Bendamustine|Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
16301414|NCT00636792|Drug|Rituximab|Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5
16301415|NCT00636766|Drug|atorvastatin|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
16301416|NCT00636766|Drug|rimonabant|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
16301417|NCT00636766|Drug|rosiglitazone|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
16301418|NCT00636766|Drug|metformin|A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)
16301419|NCT00636740|Drug|Zoledronic Acid 20mg Tablets|Oral enteric coated tablets, 20mg, weekly, 8 weeks
16301420|NCT00636740|Drug|Zoledronic Acid|Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
16301421|NCT00636740|Drug|Zoledronic Acid 20mg Tablets|Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
16301422|NCT00636727|Procedure|arthrocentesis|Irrigate the TMJ with lactated ringers
16301423|NCT00636727|Procedure|arthroscopy|The TMJ will be inspected with an arthroscope and the joint irrigated with lactated ringers
16301424|NCT00636727|Procedure|arthroplasty|The disc will be surgically repositioned with open surgery
16301425|NCT00636714|Behavioral|Nursing judgement|Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L
16301426|NCT00636714|Behavioral|Nomogram|A preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be
16301427|NCT00636701|Device|Repetitive Transcranial Magnetic Stimulation|We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
16301428|NCT00636688|Behavioral|Lifestyle - detailed advice|Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity
16301429|NCT00636688|Behavioral|Control - general information|General information about healthy food choices and exercise
16301430|NCT00636675|Behavioral|Falls QI|"Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:
~In-House Falls Coordinator training on content and falls processes.
~Case-based modules about fall prevention and tailored for various team members.
~Academic Detailing in which researcher consults with staff regarding challenging residents with falls.
~Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.
~Toolbox: Handbook of useful measures and worksheets."
16301470|NCT00636363|Device|Ciba Vision Aquify Multipurpose Solution|daily care for contact lenses
16301471|NCT00636350|Dietary Supplement|Pepper|pepper carotenoids as meals
16301921|NCT00633412|Drug|Esomeprazole|20mg oral daily
16301431|NCT00636675|Behavioral|Connect|"Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:
~In-class learning sessions introduce interaction strategies.
~Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.
~Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role."
16301432|NCT00636662|Other|Non-invasive diagnostic testing|No patient treatment is altered by enrollment in this trial
16301433|NCT00636649|Drug|Escitalopram|10-20 mg
16301434|NCT00636649|Drug|Placebo|Placebo
16301435|NCT00636636|Drug|Gabapentin Extended Release tablets|Once-Daily; 300 mg and 600 mg tablets
16301436|NCT00636636|Drug|Placebo|Once daily; 300 mg and 600 mg tablets
16301437|NCT00636623|Other|Pilates exercises|15 FM patients participated in the PE programme three times a week during a 4-week period
16301438|NCT00636623|Other|Connective tissue massage|21 patients received CTM, three times a week during a 4-week period
16301439|NCT00636610|Drug|Vismodegib 150 mg|Vismodegib 150 mg was provided in hard gelatin capsules in 3 different strengths, 25 mg, 125 mg, and 150 mg.
16301440|NCT00636610|Drug|Placebo to vismodegib|Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.
16301441|NCT00636610|Drug|Bevacizumab|Bevacizumab 5 mg/kg was administered intravenously (IV) over 90 minutes for the first infusion, shortening to 60 and 30 minutes for subsequent infusions.
16301442|NCT00636610|Drug|Modified FOLFOX|Following administration of bevacizumab, patients received oxaliplatin 85 mg/m^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m^2 (d,I-racemic form, or 200 mg/m^2 I-isomer form) IV administered over 120 minutes, then fluorouracil 400 mg/m^2 administered as an IV bolus, then 2400 mg/m^2 administered as a continuous IV infusion over 46 hours.
16301443|NCT00636610|Drug|FOLFIRI|Following administration of bevacizumab, patients received irinotecan 180 mg/m^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m^2 (d,I-racemic form, or 200 mg/m^2 I-isomer form) administered IV over 120 minutes, then fluorouracil 400 mg/m^2 administered as an IV bolus, then fluorouracil 2400 mg/m^2 administered as a continuous IV infusion over 46 hours.
16301444|NCT00636584|Drug|sodium nitroprusside|sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
16301445|NCT00636584|Drug|placebo|placebo
16301446|NCT00636571|Behavioral|Exercise|Upright bike intervention for post-surgical lung cancer survivors.
16301447|NCT00636558|Drug|CVA21|IV infusion, dose escalation of one or two infusions of escalating strength
16301448|NCT00636545|Drug|Oblimersen (Genasense)|Intravenous
16301449|NCT00636545|Drug|Oblimersen (Genasense)|Intravenous
16301450|NCT00636519|Biological|Botulism Antitoxin Bivalent (Equine) Types A and B|One vial of Botulism Antitoxin Bivalent(Equine) Types A and B (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage A
16301451|NCT00636519|Biological|Botulism Antitoxin Heptavalent (Equine) Types A-G|One vial of Heptavalent Botulism Antitoxin (1:10 in saline) or an Equivalent Volume of Placebo on Day 0 in Stage B
16301452|NCT00636506|Device|AMS 700 IPP with MS Pump|AMS 700 Series Inflatable Penile Prosthesis with MS Pump
16301453|NCT00636493|Device|fluocinolone acetonide (Retisert Implant)|sustained release device consisting of 0.59 mg of fluocinolone acetonide
16301454|NCT00636480|Drug|Chlorhexidine gluconate|Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
16301455|NCT00636480|Drug|ChloraPrep One Step|Administer topically
16301456|NCT00636480|Drug|Sterile saline|0.9% NaCl solution
16301457|NCT00636467|Other|No name|Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
16301458|NCT00636454|Behavioral|Coping skills training (CST) for chronic pain|Participants will attend 10 sessions lasting between 45 and 60 minutes each. Topics will include relaxation training, managing activity cycles, and changing thought patterns to reduce the negative effects of pain.
16301459|NCT00636454|Other|Usual care|Participants will receive the care usually given to patients with knee or hip OA.
16301460|NCT00636441|Drug|Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)|Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) or Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy
16301461|NCT00636428|Drug|Midazolam|oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.
16301462|NCT00636415|Drug|morphine|1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and 25 mg (10 ml) 0.25% bupivacaine without epinephrine.
16301463|NCT00636402|Procedure|Cold Knife Tonsillectomy|Cold Knife Tonsillectomy (CKT) will be done on the other side.
16301464|NCT00636402|Procedure|Vessel Sealing System Tonsillectomy|Intervention by Vessel Sealing System Tonsillectomy (VSST) will be randomized and will be performed on one side.
16301465|NCT00636389|Device|Polyflux 210H dialyzer|Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
16301466|NCT00636389|Device|Polyflux HD-C4|Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
16301467|NCT00636376|Procedure|Place HOB in alternate positions from 0-50 degrees.|Patients will receive an US while the HOB(Elevation of the head of bed) is 30 degrees(baseline) then they will increase the angle to 40 degrees, then 50 degrees. Another US will be done then in 20, 10, and o degree angles. Then another US will be done
16301468|NCT00636363|Device|Bausch & Lomb Multipurpose Solution - Rub Care|Daily care for contact lenses - rub care regimen
16301469|NCT00636363|Device|Bausch & Lomb Multipurpose Solution - No Rub Care|Daily care for contact lenses - no rub care regimen
16301472|NCT00636337|Behavioral|Attention Training|Computer program training for attention difficulties.
16301473|NCT00636337|Behavioral|Placebo|Comparison computer program
16301474|NCT00636324|Device|Nasal CPAP, level 7 to 9 cmH2O|Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
16301475|NCT00636324|Device|Nasal CPAP, level 4 to 6 cmH2O|Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation
16301476|NCT00636311|Drug|Ifosfamide, Gemcitabine, Vinorelbine|Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
16301477|NCT00636311|Drug|Bortezomib + IGEV|Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
16301478|NCT00636298|Drug|Bevacizumab, cetuximab|"Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly
~Bevacizumab - 10 mg/kg every 2 weeks"
16301479|NCT00636285|Drug|Placebo|Placebo
16301480|NCT00636285|Drug|BSYX-A110|BSYX-A110, Dosed intravenously, 3 mg/kg
16301481|NCT00636285|Drug|BSYX-A110|BSYX-A110, Dosed intravenously, 10 mg/kg
16301482|NCT00636259|Drug|Bicalutamide (Casodex)|150mg
16301483|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.
16301484|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.
16301485|NCT00636246|Drug|sertraline|Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
16301486|NCT00636246|Drug|sertraline|Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
16301487|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
16301488|NCT00636246|Drug|Placebo|Tablets, orally once per day for 8 weeks
16301489|NCT00636246|Drug|sertraline/[S,S]-reboxetine|Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
16301490|NCT00636246|Drug|[S,S]-reboxetine monotherapy|Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
16301491|NCT00636207|Drug|Montelukast|Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
16301492|NCT00636207|Drug|Placebo|Placebo dry powder inhaler
16301493|NCT00636194|Device|Bausch & Lomb Multipurpose Solution|daily care of contact lenses
16301494|NCT00636194|Device|Alcon OptiFree Replenish Multipurpose Solution|daily care for contact lenses
16301495|NCT00636181|Device|Auto AFlex|Positive pressure therapy treatment
16301496|NCT00636181|Device|Auto CPAP|Positive pressure therapy treatment
16301497|NCT00636181|Device|CPAP|Positive pressure therapy treatment
16301498|NCT00636168|Drug|ipilimumab|IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
16301499|NCT00636168|Drug|Placebo|IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
16301500|NCT00636155|Drug|cenersen sodium|2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4
16301501|NCT00636155|Drug|Rituximab|375 mg/m2 on day 2
16301502|NCT00636155|Drug|Cyclophosphamide|250 mg/m2 on days 2, 3, and 4
16301503|NCT00636155|Drug|Fludarabine|25 mg/m2 on days 2, 3, and 4
16301504|NCT00636142|Biological|Infliximab|5 mg/kg body weight, maximal dose 500 mg; intravenous administration
16301505|NCT00636129|Behavioral|Relaxation Response + Stress Management Curriculum|Subjects will receive 8 weeks of Stress Management curriculum and guidance through 20 minute Relaxation Response with a research coordinator. They will also practice 20 minutes of Relaxation Response at home daily.
16301506|NCT00636116|Biological|Crotalinae (pit viper) equine immune F(ab)2|Anavip with Anavip Maintenance Therapy
16301507|NCT00636116|Biological|Crotalinae (pit viper) equine immune F(ab)2|Anavip with Placebo Maintenance Therapy
16301508|NCT00636116|Biological|Crotalidae Polyvalent Immune Fab, ovine|CroFab with CroFab Maintenance Therapy
16301509|NCT00636103|Drug|CUF2|"0.619g of dried aqueous extract of equal weights of 5 herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix Stemonae, Bulbus Fritillariae Cirrhosae, Radix scutellariae).
~The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
~Duration: 6 months"
16301510|NCT00636103|Other|Placebo|"Dark coloured corn starch
~The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
~Duration: 6 months"
16301511|NCT00636077|Device|Polyflux HD-C4 Big|Three consecutive treatments with the HD-C4 Big. During the third treatment, dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
16301512|NCT00636077|Device|HD-C4 Small|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
16301513|NCT00636077|Device|Optiflux 160NR|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
16301514|NCT00636077|Device|Optiflux 200NR|Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
16301515|NCT00636064|Drug|Parecoxib Sodium/Valdecoxib|Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
16301516|NCT00636064|Drug|Placebo/Valdecoxib|Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
16301517|NCT00636064|Other|Placebo/Placebo|Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
16301518|NCT00636038|Dietary Supplement|corn beta-carotene|yellow corn beta-carotene in a 1 mg level to be taken as corn porridge in one meal by volunteers
16301519|NCT00636012|Procedure|verum acupuncture|acupuncture at St36 and Pe6
16301520|NCT00636012|Procedure|sham acupuncture|superficial needling at sham points
16301521|NCT00635999|Behavioral|Applied relaxation and self-control desensitization|Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.
16301522|NCT00635999|Other|Cognitive therapy (CT)|CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.
16301523|NCT00635999|Behavioral|Cognitive-Behavioral Therapy|Includes all of the techniques in the other 2 interventions.
16301524|NCT00635986|Drug|Fentanyl|100 mcg Fentanyl intravenous or epidural route
16301525|NCT00635973|Drug|Gefitinib (Iressa)|Iressa
16301526|NCT00635960|Drug|Growth Hormone (Somatropin)|The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.
16301527|NCT00635960|Drug|Placebo|Same as for Growth hormone group
16301528|NCT00635947|Other|isotonic solution|1.5 L- during 2-4hours
16301529|NCT00635947|Other|water|1.5 L- during 2-4hours
16301530|NCT00635947|Other|water|200mL- during 2-4hours
16301531|NCT00635934|Device|A-MAV™ disc|The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.
16301532|NCT00635921|Drug|ziprasidone|Dose flexible from 40 to 200 mg/d during 12 weeks
16301533|NCT00635921|Drug|Placebo|flexible doses from 40 to 200 mg/d during 12 weeks
16301534|NCT00635895|Other|Manual Lymph Drainage Therapy and Connective Tissue Massage|The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
16301535|NCT00635882|Drug|mometasone furoate/formoterol 100/10 mcg|mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
16301536|NCT00635882|Drug|mometasone furoate/formoterol 200/10 mcg|mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
16301537|NCT00635882|Drug|mometasone furoate/formoterol 400/10 mcg|mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
16301538|NCT00635882|Drug|MF DPI 200 mcg|MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days
16301539|NCT00635882|Drug|MF MDI 200 mcg|MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days
16301540|NCT00635882|Drug|Placebo|MF/F MDI placebo twice daily (BID) (2 inhalations)
16301541|NCT00635869|Behavioral|ARCC standard information|EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs
16301542|NCT00635869|Behavioral|ARCC enhanced|same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation
16301543|NCT00635869|Behavioral|Placebo|didactic education sessions on physical assessment
16301544|NCT00635856|Drug|Gefitinib|Iressa
16301545|NCT00635843|Device|MAVERICK™ Disc|The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
16301546|NCT00635843|Device|LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft|The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
16301547|NCT00635830|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
16301548|NCT00635817|Drug|Leuprolide acetate 11.25 mg|Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
16301549|NCT00635817|Drug|Leuprolide acetate 30 mg|Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
16301550|NCT00635804|Drug|MK-3281|MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males)
16301922|NCT00633412|Drug|Ranitidine|150mg oral twice daily
16301551|NCT00635804|Drug|Placebo to MK-3281|Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
16301552|NCT00635791|Drug|Sorafenib|Given by mouth
16301553|NCT00635791|Drug|Vorinostat|Given by mouth
16301554|NCT00635778|Drug|dalotuzumab|Administered as an IV infusion over one to two hours
16301555|NCT00635765|Drug|C2L-OCT-01 PR 30 mg|Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.
16301556|NCT00635752|Other|TF-CBT|TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
16301557|NCT00635752|Other|Treatment as Usual (TAU)|Participants will receive regular therapy as is usually practiced in clinics
16301558|NCT00635739|Dietary Supplement|Whey protein|powdered, 46g supplement dissolved in fluids, twice daily
16301559|NCT00635739|Dietary Supplement|Maltodextrin placebo|powdered, 46g supplement dissolved in fluids, twice daily
16301560|NCT00635726|Drug|Methotrexate|Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
16301561|NCT00635726|Drug|Vinblastine|Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
16301562|NCT00635726|Drug|Doxorubicin|Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
16301563|NCT00635726|Drug|Cisplatin|Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
16301564|NCT00635726|Drug|Cisplatin|Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
16301565|NCT00635726|Drug|Gemcitabine|Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
16301566|NCT00635713|Drug|Fulvestrant|125mg
16301567|NCT00635713|Drug|Anastrozole|ARIMIDEX
16301568|NCT00635713|Drug|Fulvestrant|250mg
16301569|NCT00635700|Drug|ziprasidone|20-160 mg/d
16301570|NCT00635700|Drug|placebo|placebo
16301571|NCT00635687|Device|Fibroscan|transient elastography measure - Liver stiffness
16301572|NCT00635674|Device|CPAP device - REMstar Plus, Respironics, Murrysville, USA|continuous positive airway pressure device with heated humidification
16301573|NCT00635648|Drug|caspofungin acetate|Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy.
16301574|NCT00635635|Behavioral|Guided Imagery Audio|Guided Imagery Audio listened to 5x per week
16301575|NCT00635635|Behavioral|Music Audio|Music only audio to be listened to 5x per week
16301576|NCT00635622|Drug|LACTIN-V|Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
16301577|NCT00635622|Drug|Placebo control substance|Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
16301578|NCT00635609|Drug|Doxycycline hyclate (Doryx)|150mg/day, oral, delayed release tablets
16301579|NCT00635609|Drug|Doxycycline hyclate|100 mg/day, oral, tablets, immediate release
16301580|NCT00635596|Biological|MT110|MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses
16301581|NCT00635583|Other|Increased Dairy Consumption|"3 additional servings of dairy (two of which must be milk or yogurt)
~8 oz milk
~6 oz yogurt
~1.5 oz cheese"
16301582|NCT00635570|Drug|Ortho Tri-cyclen Lo|Low dose oral contraceptive
16301583|NCT00635570|Device|NuvaRing|Contraceptive vaginal ring
16301584|NCT00635557|Drug|MPC-6827 + Carboplatin|MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.
16301585|NCT00635544|Other|dietary treatment|dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
16301586|NCT00635544|Other|dietary treatment|dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
16301587|NCT00635531|Other|placebo|Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
16301588|NCT00635531|Drug|alprazolam XR|Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.
16301589|NCT00635518|Behavioral|Ten Steps for Healthy Feeding children programme|Ten Steps for Healthy Feeding children
16301590|NCT00635505|Drug|albuterol HFA (Armstrong's)|180 mcg QID 12 weeks
16301591|NCT00635505|Drug|albuterol HFA (Proventil HFA)|180 mcg QID 12 weeks
16301592|NCT00635505|Drug|HFA placebo|2 actuations QID 12 weeks or until use of rescue drug
16301593|NCT00635492|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16301594|NCT00635492|Drug|any human insulin or analog insulin(s) given in any regimen by subcutaneous injection|
16301595|NCT00635479|Device|VAC device|Vacuum Assisted Closure (VAC) device for surgical incision
16301596|NCT00635479|Other|Gauze dressing|Gauze dressing for surgical incision
16301638|NCT00635219|Drug|Vortioxetine (Lu AA21004)|2.5 mg/day; encapsulated tablets; orally
16301639|NCT00635219|Drug|Vortioxetine (Lu AA21004)|5 mg/day; encapsulated tablets; orally
16301640|NCT00635219|Drug|Vortioxetine (Lu AA21004)|10 mg/day; encapsulated tablets; orally
16301597|NCT00635466|Procedure|laparoscopic surgery for rectal carcinoma|Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).
16301598|NCT00635453|Behavioral|Dietary Advice|The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.
16301599|NCT00635440|Device|neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)|Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day.The amplitude of the electrical stimuli in the stimulated leg was adjusted to ensure maximum tolerable muscle contraction.
16301600|NCT00635440|Device|neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)|Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day. Current was increased until the patient could feel a tingling sensation but no muscle contraction was visible or palpable.
16301601|NCT00635427|Biological|VPRIV®|Intravenous infusion, every other week (EOW)
16301602|NCT00635414|Drug|Esomeprazole|40mg oral
16301603|NCT00635414|Drug|Esomeprazole|15 minute intravenous infusion
16301604|NCT00635401|Drug|Varenicline|0.5 mg BID for 7 weeks
16301605|NCT00635388|Other|Placebo|oral, placebo, once/day for 12 weeks
16301606|NCT00635388|Other|Lactobacillus (Probiotic 1)|oral, Lactobacillus, once/day for 12 weeks
16301607|NCT00635388|Other|Lactobacillus and Bifidobacterium (Probiotic 2)|oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
16301608|NCT00635375|Device|LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)|35-50 mW/cm2/nm
16301609|NCT00635375|Device|Metal halide phototherapy (Spot PT metal halide phototherapy)|29.3-57.6 mW/cm2/nm
16301610|NCT00635375|Device|LED bank phototherapy (Natus neoBlue LED bank phototherapy)|12-35 mW/cm2/nm
16301611|NCT00635375|Device|Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)|29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm
16301612|NCT00635362|Device|Levonorgestrel-releasing intrauterine system (LNG-IUS)|Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
16301613|NCT00635362|Device|Levonorgestrel-releasing intrauterine system (LNG-IUS)|Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
16301614|NCT00635349|Drug|Meloxicam|Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
16301615|NCT00635349|Drug|Aceclofenac|Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
16301616|NCT00635349|Drug|Tramadol Hydrochloride Plus Acetaminophen|Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam [7.5 mg or 15 mg once daily] or aceclofenac [100 mg twice daily]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).
16301617|NCT00635336|Biological|MPHOSPH1 and DEPDC1|DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
16301618|NCT00635323|Drug|Irinotecan plus capecitabine|Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for
16301619|NCT00635310|Procedure|Percutaneous liver biopsy|Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
16301620|NCT00635310|Procedure|Percutaneous liver biopsy|Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
16301621|NCT00635297|Procedure|Percutaneous vertebroplasty|PMMA injection 3-10 milliliter in each treated vertebrae
16301622|NCT00635284|Drug|ABI-009|nab-rapamycin
16301623|NCT00635258|Drug|triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)|0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.
16301624|NCT00635258|Drug|GnRH antagonist (Orgalutran®)|GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
16301625|NCT00635245|Biological|figitumumab|
16301626|NCT00635245|Other|imaging biomarker analysis|
16301627|NCT00635245|Other|laboratory biomarker analysis|
16301628|NCT00635245|Other|pharmacological study|
16301629|NCT00635245|Procedure|conventional surgery|
16301630|NCT00635245|Procedure|magnetic resonance spectroscopic imaging|
16301631|NCT00635245|Procedure|neoadjuvant therapy|
16301632|NCT00635232|Drug|irbesartan|300 mg (2 x 150 mg capsules) once daily for 12 weeks
16301633|NCT00635232|Drug|placebo|placebo capsules once daily for 12 weeks
16301634|NCT00635232|Drug|PS433540|200 mg (2 x 100 mg capsules) once daily for 12 weeks
16301635|NCT00635232|Drug|PS433540|400 mg (4 x 100 mg capsules) once daily for 12 weeks
16301636|NCT00635232|Drug|PS433540|800 mg (8 x 100 mg capsules) once daily for 12 weeks
16301637|NCT00635219|Drug|Placebo|capsules; daily; orally
16301641|NCT00635219|Drug|Duloxetine|60 mg/day; encapsulated capsules; orally
16301642|NCT00635206|Device|BiPap auto with Fi Flex|"MinEPAP = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
~MaxIPAP = 25 cm H2O
~MinPS = 2 cm H2O (cannot be adjusted)
~MaxPS = 8 cm H2O
~Bi-Flex setting of 3"
16301643|NCT00635206|Device|Standard CPAP|CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)
16301644|NCT00635193|Drug|M200 (Volociximab)|7.5 mg/kg, IV infusion every week until disease progression
16301645|NCT00635193|Drug|Liposomal Doxorubicin|40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
16301646|NCT00635193|Drug|M200 (Volociximab)|15 mg/kg, IV infusions every week until disease progression
16301647|NCT00635193|Drug|M200 (Volociximab)|15 mg/kg, IV infustions every other week until disease progression
16301648|NCT00635180|Behavioral|isometric exercise|
16301649|NCT00635167|Drug|Contrast Enhanced-Transrectal Ultrasound|Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).
16301650|NCT00635154|Biological|Anakinra (IL-1Ra)|100mg daily subcutaneously administered
16301651|NCT00635154|Drug|Dexamethasone acetate|"Low dose - 20 mg/week
~High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)"
16301652|NCT00635141|Drug|hypertonic saline (7 %) and isotonic saline (0.9%)|Patients in study arm 1 will receive hypertonic saline (7 %) during the first phase of the study and will crossover to placebo (0.9% isotonic saline) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
16301653|NCT00635141|Drug|hypertonic saline (7 %) and isotonic saline (0.9%)|Patients in study arm 2 will receive placebo (0.9% isotonic saline) during the first phase of the study and will crossover to hypertonic saline (7 %) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
16301654|NCT00635128|Biological|Boostrix-Polio|A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
16301655|NCT00635115|Device|a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal)|
16301656|NCT00635115|Device|an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)|
16301657|NCT00635102|Drug|D-Cycloserine PO and Glycine IV|Test days will involve administration of D-Cycloserine in the morning in pill form then 4 hours later a 30 minute infusion of Glycine.
16301658|NCT00635102|Drug|Placebo D-Cycloserine PO and placebo Glycine IV|Placebo
16301659|NCT00635102|Drug|Placebo D-Cycloserine PO and Glycine IV|
16301660|NCT00635102|Drug|D-Cycloserine PO and placebo Glycine IV|
16301661|NCT00635089|Drug|reslizumab|
16301662|NCT00635076|Other|placebo|Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
16301663|NCT00635076|Drug|alprazolam XR|Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.
16301664|NCT00635063|Drug|AD 923|
16301665|NCT00635050|Drug|Doxil, Paclitaxel, Cyclophosphamide, Avastin|"Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.
~Regimen B: Doxil 30 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation."
16301666|NCT00635037|Drug|bupivacaine and acupuncture|"trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h.
~acupuncture twice a week"
16301667|NCT00635024|Biological|anti-thymocyte globulin|2.5 mg/kg
16301668|NCT00635024|Drug|melphalan|16 mg/m^2
16301669|NCT00635011|Behavioral|psychotherapy|Cognitive Behavioral therapy
16301670|NCT00634998|Dietary Supplement|Vitamin C|1000mg Vitamin C capsules orally twice daily
16301671|NCT00634998|Dietary Supplement|Placebo|1000mg Placebo capsules orally twice daily for 90 days
16301672|NCT00634985|Drug|eletriptan|40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
16301673|NCT00634972|Drug|ACULAR|infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
16301674|NCT00634972|Drug|REFRESH TEARS|infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
16301675|NCT00634972|Drug|placebo|
16301676|NCT00634959|Drug|Maraviroc (UK-427,857)|150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
16301677|NCT00634959|Drug|Maraviroc (UK-427,857)|100 mg oral tablet once daily while fasted on Days 1-10
16301678|NCT00634959|Drug|Maraviroc (UK-427,857)|300 mg oral tablet once daily while fasted on Days 1-10
16301679|NCT00634959|Drug|Maraviroc (UK-427,857)|150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
16301680|NCT00634959|Other|Placebo|Matching placebo oral tablet on Days 1-10 (fed and fasted)
16301681|NCT00634946|Drug|SI-6603|SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
16301682|NCT00634946|Drug|Placebo|Placebo is administrated into the nucleus pulposus of an intervertebral disc.
16301683|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
16301684|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
16301685|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
16301686|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
16301687|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
16301688|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
16301689|NCT00634933|Drug|TRU-015|IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
16301690|NCT00634933|Drug|Methylprednisolone|IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
16301691|NCT00634933|Drug|Prednisone|Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
16301692|NCT00634920|Drug|everolimus|Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2.
16301693|NCT00634920|Drug|cyclosporine A|CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method
16301694|NCT00634920|Drug|Enteric Coated Mycophenolate Sodium (EC-MPS)|Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate)
16301695|NCT00634920|Drug|corticosteroids|For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.
16301696|NCT00634920|Drug|Basiliximab|Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.
16301697|NCT00634907|Genetic|Pharmacogenetic-based warfarin dosing|"Prior to elective joint replacement surgery a blood sample is collected for genetic information(genotyping)which was used for calculating warfarin doses for patients randomized to the cytochrome arm. Outcomes in terms of efficacy, safety, and management of warfarin were compared between this group and the group in which warfarin doses are determined per usual care.
~NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin was not specific to this study, nor was the duration of prophylaxis, however, warfarin dosing was influenced by the study arm as noted above."
16301698|NCT00634907|Other|Usual care warfarin dosing|"For patients in arm 2, the control group, warfarin dosing is per usual care. Outcomes in terms of safety, efficacy, and warfarin management was compared to that of patients in the other arm, who receive warfarin dosing based on genotyping.
~NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin was not specific to this study, nor was the duration of prophylaxis, however, warfarin dosing was influenced by the study arm as noted above."
16301699|NCT00634894|Drug|Femara|2.5 mg by mouth daily x 12 weeks
16301700|NCT00634894|Drug|Placebo|Placebo capsule by mouth daily x 12 weeks
16301701|NCT00634881|Biological|Alemtuzumab i.v.|"Alemtuzumab will be administered once per week as a 2 h infusion
~Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration
~Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)
~Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"
16301702|NCT00634881|Biological|Alemtuzumab s.c.|"Alemtuzumab will be administered once per week subcutaneously
~Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration
~Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)
~Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"
16301703|NCT00634868|Other|Qray light therapy device|The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.
16301704|NCT00634868|Device|Qray light therapy device-Sham|non curative light- the device emits the same broad light, but with very low intensity
16301705|NCT00634842|Drug|insulin detemir|Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
16301706|NCT00634842|Drug|insulin detemir|Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
16301707|NCT00634829|Drug|albuterol (Armstrong Albuterol HFA)|2 inhalations of 108 mcg albuterol sulfate prior to exercise, single dose
16301708|NCT00634829|Drug|Albuterol Sulfate (Provenetil-HFA)|2 inhalations of Proventil-HFA, 108 mcg/inhalation prior to exercise
16301709|NCT00634829|Drug|Placebo-HFA|Placebo containing HFA propellant without active drug substance
16301710|NCT00634816|Radiation|DXA Scan|The patients will undergo total body, spine, proximal femoral, and forearm DEXA testing in a standardized fashion. Patients who have undergone limb surgery or irradiation to an extremity for local disease control will also undergo selected site DEXA or pQCT scanning, depending upon the site, of the affected extremity and the identical site on the contra-lateral extremity.
16301711|NCT00634803|Behavioral|CBT|Cognitive behavioral therapy
16301712|NCT00634803|Drug|Buprenorphine|buprenorphine/naloxone
16301713|NCT00634803|Other|Educational Counseling|Didactic, lecture-discussion format to supplement information and advice provided by physicians
16301714|NCT00634803|Other|Physician Management|Brief physician counseling
16301757|NCT00634504|Drug|high-dose methotrexate, leucovorin|standard of care, leucovorin every 6 hours
16301715|NCT00634790|Drug|alprazolam XR|Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.
16301716|NCT00634777|Other|pet scan|pet scan
16301717|NCT00634751|Drug|Oxaliplatin|On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water.
16301718|NCT00634751|Drug|Capecitabine|Each course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis.
16301719|NCT00634751|Drug|Sorafenib|"Cohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating).
~Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length
~Sorafenib 200 mg BID Oral Daily Every 28 days
~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd.
~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
~Sorafenib 400 mg BID Oral Daily Every 28 days"
16301720|NCT00634738|Procedure|Ischemic Compression (thumb Pressure)|Pressure, one thumb on the other, applied on the trigger points
16301721|NCT00634725|Drug|capecitabine|
16301722|NCT00634725|Drug|erlotinib hydrochloride|
16301723|NCT00634725|Drug|gemcitabine hydrochloride|
16301724|NCT00634725|Other|laboratory biomarker analysis|
16301725|NCT00634725|Radiation|radiation therapy|
16301726|NCT00634712|Drug|Candesartan|
16301727|NCT00634712|Drug|Placebo|
16301728|NCT00634699|Procedure|Active Comparator, ischemic compressions|Ischemic Compressions,3 times a week,5 weeks.
16301729|NCT00634686|Dietary Supplement|DHA/EPA|1.2 gram capsule daily for 6 months
16301730|NCT00634686|Dietary Supplement|Placebo capsule|daily for 6 months
16301731|NCT00634686|Dietary Supplement|Calcium with vitamin D|1000 mg of calcium with 1000 IU vitamin D daily for 6 months
16301732|NCT00634673|Other|sandwich|standard meal:sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate)
16301733|NCT00634660|Drug|rAvPAL-PEG|rAvPAL-PEG will be administered as a single, SC injection at dose levels of 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg. The duration of treatment is a single dose of study drug with 42 days (6 weeks) of follow-up.
16301734|NCT00634647|Drug|Satraplatin|80 mg/m^2 days 1-5 of every 35 day cycle
16301735|NCT00634647|Drug|prednisone|5 mg twice daily every 35 days
16301736|NCT00634634|Drug|Sorafenib|sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
16301737|NCT00634634|Drug|Letrozole|Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
16301738|NCT00634621|Drug|Hexaminolevulinate (Hexvix)|Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.
16301739|NCT00634608|Other|Health Information Prescription|The patient education materials will consist of approximately 21 topics representing some of the most common conditions seen at the Fairview Internal Medicine Clinic. Twenty-one e-mails, one per topic, will be created by Fairview physicians to be distributed to selected clinic patients. There will be a standard e-mail for each condition with a specific link to MedlinePlus. To create the targeted health information topic email, the physician will review the information available at MedlinePlus. The physician will then select several links of appropriate information and, using the template, will write a short annotation on each link.
16301740|NCT00634595|Drug|E10A|E10A 1*10(12)VP, intratumoral injection, d1 d8, repeat every 3 weeks for 4 cycles
16301741|NCT00634595|Drug|Cisplatin|25 mg/m2/d ivd d3 d4 d5, repeat every 3 weeks for 4 cycles.
16301742|NCT00634595|Drug|Paclitaxel|160 mg/m2 ivd d3, repeat every 3 weeks for 4 cycles.
16301743|NCT00634582|Drug|paricalcitol|
16301744|NCT00634582|Other|immunoenzyme technique|
16301745|NCT00634582|Other|laboratory biomarker analysis|
16301746|NCT00634582|Procedure|dual x-ray absorptometry|
16301747|NCT00634582|Procedure|quality-of-life assessment|
16301748|NCT00634569|Biological|Flebogamma 5% DIF|Intravenous Immune Globulin (Human)
16301749|NCT00634556|Drug|levodopa solution 2mg/ml for i.v. use|2mg/mL in normal saline
16301750|NCT00634556|Drug|placebo|normal saline
16301751|NCT00634543|Drug|Tramadol hydrochloride/ Acetaminophen|Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
16301752|NCT00634543|Drug|Gabapentin|Participants will receive Gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
16301753|NCT00634530|Behavioral|Dietary Advice|The specific dietary advices according to nutritional status. Main advices: reduction of fat and sugar intake, increase of total energy, dairy intake of vegetables and fruits.
16301754|NCT00634517|Drug|Armstrong Albuterol Sulfate Inhalation Aerosol|Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
16301755|NCT00634517|Drug|Albuterol Sulfate Inhalation Aerosol|Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
16301756|NCT00634504|Drug|glucarpidase, high-dose methotrexate, leucovorin|single intravenous dose
16301758|NCT00634491|Drug|sodium bicarbonate|150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
16301759|NCT00634491|Drug|Acetazolamide|Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
16301760|NCT00634491|Drug|normal salin|1 cc/kg/hr 6 hour before and after angiography
16301761|NCT00634478|Radiation|Pre-lemniscal Radiation Deep Brain Stimulation|
16301762|NCT00634465|Device|RSA Beads|Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes
16301763|NCT00634452|Biological|MDX-1401|IV weekly for 4 weeks
16301764|NCT00634439|Drug|atomoxetine|
16301765|NCT00634439|Drug|Stimulants|Methylphenidate, amphetamines (including Adderall and mixed salts)
16301766|NCT00634439|Other|No intervention (general population)|
16301767|NCT00634426|Procedure|Surgical excision of the metastatic process|Surgical excision of the metastatic process
16301768|NCT00634426|Radiation|Radiotherapy of the metastatic spine process|Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
16301769|NCT00634413|Drug|Theophylline - ADC4022|Inhaled theophylline (ADC4022) administered twice daily for 28 days
16301770|NCT00634413|Drug|Placebo|Inhaled matching placebo administered twice daily for 28 days
16301771|NCT00634413|Drug|Budesonide|Inhaled budesonide twice daily for 28 days
16301772|NCT00634400|Drug|Candesartan|
16301773|NCT00634400|Drug|Placebo|
16301774|NCT00634387|Dietary Supplement|Anthocyans|Anthocyans
16301775|NCT00634387|Other|placebo|
16301776|NCT00634387|Dietary Supplement|Anthocyans|
16301777|NCT00634374|Device|Rx Medibottle|Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup
16301778|NCT00634361|Drug|ethyl-eicosapentaenoic acid|2 mg per day
16301779|NCT00634348|Drug|Aripiprazole|Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days
16301780|NCT00634348|Drug|Ziprasidone|Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days
16301781|NCT00634322|Drug|glucarpidase|IV dose based on weight, two doses given for 5 minutes, 24 hours apart
16301782|NCT00634322|Drug|leucovorin|IV or po given every 6 hours
16301783|NCT00634309|Drug|Candesartan|
16301784|NCT00634309|Drug|Placebo|
16301785|NCT00634296|Other|Inspiratory muscle added by aerobic to aerobic alone|Inspiratory muscle added by aerobic to aerobic alone
16301786|NCT00634283|Drug|venlafaxine|venlafaxine IR 150mg
16301787|NCT00634270|Drug|Sirolimus|This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry.
16301788|NCT00634257|Behavioral|Questionnaires|Nine questionnaires taking about 40 minutes to complete.
16301789|NCT00634244|Drug|alvocidib|Given IV
16301790|NCT00634244|Drug|mitoxantrone hydrochloride|Given IV
16301791|NCT00634244|Drug|carboplatin|Given IV
16301792|NCT00634244|Drug|cytarabine|Given IV
16301793|NCT00634244|Drug|sirolimus|Given PO
16301794|NCT00634244|Drug|etoposide|Given IV
16301795|NCT00634244|Drug|topotecan hydrochloride|Given IV
16301796|NCT00634231|Biological|AdV-tk|
16301797|NCT00634231|Drug|valacyclovir|
16301798|NCT00634231|Radiation|Radiation|
16301799|NCT00634218|Behavioral|Mail-based Self-help plus Internet-based Smoking Treatment|Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants.
16301800|NCT00634218|Behavioral|Self-Help Manual plus Telephone counseling|Participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions. The counseling sessions focus on the development of a personalized plan to quit smoking and occur over a 3 month period.
16301801|NCT00634218|Behavioral|Self-Help Manual|Participants will receive a self-help smoking cessation manual specifically developed for LGBT smokers. The manual provides information on quitting smoking and encourages the development of a personalized quit plan through various activities and exercises.
16301802|NCT00634218|Behavioral|Self-Help Manual plus Internet-based Intervention plus Telephone Counseling|Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants. Smokers will also receive 6 telephone-based counseling sessions which occur over a 3 month period
16301803|NCT00634205|Drug|Valproate plus doxorubicin|Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks
16301804|NCT00634192|Drug|tobramycin|1x300mg/d inhaled
16301805|NCT00634192|Drug|tobramycin|2x300mg/d inhaled
16301806|NCT00634179|Drug|Bortezomib|Bortezomib 1.6 mg/m² given on days 1 and 8
16301807|NCT00634179|Biological|Rituximab|Rituximab 375 mg/m²
16301808|NCT00634179|Drug|Doxorubicin|Doxorubicin 50 mg/m²
16301809|NCT00634179|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m²
16301810|NCT00634179|Drug|Vincristine|Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
16301811|NCT00634179|Drug|Prednisone|Prednisone 100 mg/day given orally on days 1-5
16301812|NCT00634166|Drug|Sulfamylon® For 5 % Topical Solution|Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.
16301813|NCT00634166|Drug|Topical Antimicrobial/Antifungal Medications|Various topical antimicrobials and antifungals.
16301814|NCT00634153|Other|Research Registry|We are asking for permission to allow us to place subject's past, current and future medical record information into a Surgical Gastrointestinal Disease Registry. By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
16301815|NCT00634140|Drug|ezetimibe|ezetimibe 10 mg daily for 4 to 6 weeks
16301816|NCT00634140|Drug|Placebo|placebo for 4-6 weeks
16301817|NCT00634114|Drug|Esomeprazole|10mg once daily oral administration
16301818|NCT00634114|Drug|Esomeprazole|20mg once daily oral administration
16301819|NCT00634114|Drug|Omeprazole|10mg once daily oral administration
16301820|NCT00634101|Device|nelfilcon A|contact lens
16301821|NCT00634101|Device|narafilcon A|contact lens
16301822|NCT00634088|Drug|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle.
16301823|NCT00634088|Drug|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle.
16301824|NCT00634088|Drug|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle.
16301825|NCT00634088|Drug|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.
16301826|NCT00634075|Drug|omega-3-fatty acids (Omegaven)|The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
16301827|NCT00634075|Drug|placebo|The enrolled patients will be randomized to receive either supplementation of fish oil-based lipid emulsion (10 % Omegaven) as group 1 or placebo (0.9% Normal Saline) as group 2 via a central venous catheter within 24 hours after ICU admission, 100 ml daily for 5 days, respectively.
16301828|NCT00634062|Drug|Lamotrigine|Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks
16301829|NCT00634062|Drug|Placebo|Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.
16301830|NCT00634049|Drug|isavuconazole|Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral
16301831|NCT00634036|Drug|pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
16301832|NCT00634036|Drug|placebo|matching placebo (inert tablet)
16301833|NCT00634010|Drug|Morphine|15 mg oral every 12 Hours; additional capsules taken every 2 hours as needed.
16301834|NCT00634010|Drug|Methadone|5 mg orally every 12 hours; additional capsules every 2 hours as needed.
16301835|NCT00633997|Drug|Vildagliptin|50 mg orally twice daily for 10 days (last dose morning of day 10)
16301836|NCT00633997|Drug|Vildagliptin|
16301837|NCT00633984|Behavioral|Cognitive Behavioral Group Therapy (CBGT)|The patient will then receive 12 weekly sessions of Cognitive Behavioral Therapy lasting approximately two and a half hours each. During these sessions, patients will receive information on the nature of social phobia and a model of treatment and will receive weekly training in how to become more comfortable with social situations, with the goal of achieving confidence in social interactions. As part of this training, the therapist will practice social interactions with the patient, who will also be asked to practice what they have learned outside of the therapists' office.
16301838|NCT00633984|Drug|D-Cycloserine|For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a 50mg pill of d-cycloserine. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.
16301839|NCT00633984|Drug|Placebo|For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a placebo. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.
16301923|NCT00633412|Drug|Esomeprazole|40mg oral tablet daily
16302361|NCT00630175|Drug|zolpidem (SL800750)|
16301840|NCT00633971|Other|complex lymphedema therapy|Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
16301842|NCT00633945|Drug|Lenalidomide|
16301843|NCT00633932|Drug|Esomeprazole|20mg once daily
16301844|NCT00633932|Drug|Esomeprazole|40 mg once daily
16301845|NCT00633932|Drug|Omeprazole|20mg once daily
16301846|NCT00633919|Biological|SLITone(TM) Dermatophagoides mix|Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years
16301847|NCT00633919|Biological|Placebo|Sublingual immunotherapy once daily for 2 years
16301848|NCT00633919|Drug|Salbutamol inhaler|200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use)
16301849|NCT00633919|Drug|Budesonide/formoterol inhaler|80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use)
16301850|NCT00633919|Drug|Prednisone tablet|5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use)
16301851|NCT00633919|Drug|Desloratadine tablet|5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use)
16301852|NCT00633919|Drug|Budesonide nasal spray|64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use)
16301853|NCT00633906|Behavioral|HORIZONS HIV Intervention|Two-session, group-based interactive HIV prevention intervention
16301854|NCT00633906|Behavioral|enhanced standard-of-care|1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV.
16301855|NCT00633893|Drug|Apixaban|Tablets, Oral, twice daily, 12 months
16301856|NCT00633893|Drug|Placebo|Tablets, Oral, twice daily, 12 months
16301857|NCT00633880|Drug|Placebo|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16301858|NCT00633880|Drug|Droxidopa|100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
16301859|NCT00633867|Device|McGrath|Tracheal intubation, using Mcgrath video-laryngoscope
16301860|NCT00633867|Device|Tracheal intubation using Macintosh Laryngoscope|Tracheal intubation using Macintosh Laryngoscope
16301861|NCT00633854|Procedure|Ultrasound examination|Immersion Ultrasound Exam: In the immersion technique, the patient lies down on the examination table. A steridrape with a central aperture is used to form a water-tight seal around the eye. After installation of 2 drops of 0.5% proparacaine HCl, a wire lid speculum is used to hold the patient's lids open. Warm 0.9% sterile saline solution is then used to create a waterbath about 1/2 inch deep to provide acoustic coupling between the transducer and the eye. The transducer (either the 10- and 20-MHz sector scan probe or the annular array) is placed in the waterbath, but does not touch the eye.
16301862|NCT00633841|Biological|AFFITOPE AD02|4 subcutaneous injections of IP in 4-week intervals
16301863|NCT00633828|Behavioral|Increased physical education in primary school (daily)|Increased physical education in primary school, 40 minutes per day
16301864|NCT00633815|Other|Supine positioning|Subjects underwent exercise testing on a stationary bicycle in the supine position
16301865|NCT00633815|Other|Upright positioning|Subjects underwent exercise testing on a stationary bicycle in the upright position
16301866|NCT00633802|Drug|Risperidone|1 mg/d risperidone for 10 weeks or placebo
16301867|NCT00633789|Drug|brivanib|Tablets, Oral, 800 mg, once daily, until progression
16301868|NCT00633789|Drug|Placebo|Tablets, Oral, 0 mg, once daily, until progression
16301869|NCT00633776|Drug|formoterol fumarate|Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
16301870|NCT00633763|Drug|18F-fallypride|Single bolus i.v. injection 60 minutes before PET-CT scanning. Maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.
16301871|NCT00633763|Drug|18F-fallypride|I.v. bolus maximum activity per single administration 5 mCi; maximum amount of drug per administration <10 micrograms.
16301872|NCT00633750|Drug|erlotinib hydrochloride|Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
16301873|NCT00633750|Genetic|TUNEL assay|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
16301874|NCT00633750|Genetic|protein expression analysis|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
16301875|NCT00633750|Other|immunohistochemistry staining method|Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
16301876|NCT00633750|Other|laboratory biomarker analysis|Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
16301877|NCT00633750|Other|liquid chromatography|Used to determine blood plasma levels of Erlotinib on the day of surgery
16301878|NCT00633750|Other|mass spectrometry|Used to determine blood plasma levels of Erlotinib on the day of surgery
16301879|NCT00633750|Other|matrix-assisted laser desorption ionization mass spectrometry|After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
16301880|NCT00633750|Procedure|therapeutic conventional surgery|Surgical treatment will occur within 24-hours following completion of therapy.
16301881|NCT00633737|Behavioral|Stress reduction intervention|In addition to standard care, patients in the intervention group will receive a one-hour individually delivered programme administered once by a psychologist at least 3 days prior to surgery. This session aims to reduce stress and involves teaching relaxation and guided imagery exercises. Patients are provided a CD (or audiotape)of the relaxation instructions to take home and practice once a day.
16301919|NCT00633438|Drug|Celecoxib|400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
16301882|NCT00633724|Biological|HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2|Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg.
16301883|NCT00633711|Device|Automatic (variable, automatically controlled) pressure CPAP|"CPAP at a variable level according to instantaneous patients' needs for treatment of sleep respiratory disorders, as evaluated by machine's software.
~Home nocturnal usage. Two-month treatment."
16301884|NCT00633711|Device|fixed continuous positive airway pressure (CPAP)|"CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
~Home nocturnal usage. Two-month treatment."
16301885|NCT00633698|Drug|Nicotinic acid (niacin)|oral medication Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day
16301886|NCT00633698|Drug|Placebo|Placebo Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day
16301887|NCT00633685|Drug|Fluoxetine|Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
16301888|NCT00633685|Drug|Placebo|Placebo will be empty gelatin capsules that are identical in size and shape to active treatment
16301889|NCT00633672|Drug|Esomeprazole|20mg Oral tablet once daily
16301890|NCT00633672|Drug|Ranitidine|150mg oral twice daily
16301891|NCT00633672|Drug|Esomeprazole|40mg oral tablet once daily
16301892|NCT00633659|Drug|Hemospan (MP4OX)|250 mL of Hemospan (MP4OX)
16301893|NCT00633659|Drug|Voluven (HES 130/0.4)|250 mL of Voluven (HES 130/0.4) solution
16301894|NCT00633646|Dietary Supplement|diets contained different levels of protein|diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d
16301895|NCT00633633|Other|Usual Care|Monthly visits with the cardiology team and a booklet about coping with heart failure.
16301896|NCT00633633|Behavioral|Exercise Training|Exercise training 3 times a week.
16301897|NCT00633633|Behavioral|Dietary Counseling|Food log, booklet, and a cookbook to help decrease the salt content in your diet.
16301898|NCT00633620|Device|Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)|colonoscopy withdrawal with NBI mode
16301899|NCT00633607|Other|Research Registry|Information regarding medical and family history is stored in the registry to be used for potential future studies
16301900|NCT00633594|Drug|Rituximab|"DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1
~Same for DL-1."
16301901|NCT00633594|Drug|Bortezomib|"DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11
~Same for DL-1."
16301902|NCT00633594|Drug|Lenalidomide|"DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest
~DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest
~DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest
~DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest"
16301903|NCT00633581|Dietary Supplement|Ascorbic acid (Vitamin C)|Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes
16301904|NCT00633581|Dietary Supplement|Normal saline|Single intravenous injection of 120ml of normal saline over 30 minutes
16301905|NCT00633568|Drug|Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel|Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
16301906|NCT00633568|Drug|Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel|Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
16301907|NCT00633542|Drug|thalidomide|100 mg/day orally until progression or severe toxicity
16301908|NCT00633542|Drug|interferon alpha|3 MU 3 times a week until progression or severe toxicity
16301909|NCT00633529|Drug|IMO-2055|0.08, 0.16, or 0.32 mg/kg SC (subcutaneous) on days 1,8,and 15 of every 21 day cycle until evidence of progressive disease, unacceptable treatment-related toxicities, withdrawal of patient consent and/or Investigator decision to withdraw study therapy with documented reason, whichever occurs first.
16301910|NCT00633516|Device|Optical Spectroscopy|Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
16301911|NCT00633490|Drug|apatinib|apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
16301912|NCT00633477|Drug|Resatorvid|Resatorvid 1.2 mg/kg emulsion, injection for 30 minutes and resatorvid 2.4 mg/kg per-day emulsion, injection, continuous infusion for 96 hours.
16301913|NCT00633477|Drug|Placebo|Resatorvid placebo-matching emulsion, injection for 30 minutes and resatorvid placebo-matching emulsion, injection, continuous infusion for 96 hours.
16301914|NCT00633464|Drug|ixabepilone|"injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.
~Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria."
16301915|NCT00633464|Drug|ixabepilone + cetuximab|"Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
~Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.
~Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
~Cetuximab 400 mg/m^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria."
16301916|NCT00633451|Other|Manual Therapy and Exercise|Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.
16301917|NCT00633451|Other|Exercise Only|A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
16301918|NCT00633438|Other|Placebo|Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
16301920|NCT00633425|Drug|GLIMEPIRIDE|
16301924|NCT00633399|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
16301925|NCT00633399|Drug|Placebo|"0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
16301926|NCT00633386|Drug|Celecoxib|400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery
16301927|NCT00633386|Other|Placebo|Matched placebo
16301928|NCT00633373|Drug|Cyclosporine Inhalation Solution|Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.
16301929|NCT00633360|Drug|Drospirenone and ethinyl estradiol|Once daily by mouth
16301930|NCT00633360|Drug|Placebo|Once daily by mouth
16301931|NCT00633347|Drug|Antagonist GnRH Cetrotide|Cetrotide 0.25 mg. daily/ 7 days
16301932|NCT00633347|Drug|Agonist GnRH Acetate Triptoreline|Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
16301933|NCT00633334|Other|Specimen bank|Patients will be asked to provide approximately 60-120 cc (4-8 tablespoons) of peripheral blood. Select patients who undergo surgical resection of their tumor will be asked to provide portions of the tumor and tumor draining lymph nodes for further analysis. In addition patients undergoing surgical resection may be asked to provide additional peripheral blood samples at time of routine follow-up (at least 4-6 weeks after initial blood draw and between subsequent draws).
16301934|NCT00633321|Biological|TA-NIC|TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
16301935|NCT00633321|Biological|Placebo|Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
16301936|NCT00633308|Device|NxStage System One (NxStage Medical, Lawrence, MA)|Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
16301937|NCT00633295|Drug|AMN107- NILOTINIB|The dose of nilotinib will be 400 mg bid.
16301938|NCT00633282|Behavioral|Life style intervention|"calorie limited diet: to subtract 500 kcal from daily mean calorie intake when entering the treatment
~activity: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate; or higher-intensity aerobic exercise for more than 90min per week with heart rate around 70% of the maximal heart rate"
16301939|NCT00633282|Drug|pioglitazone|pioglitazone tablet,15mg qd ,30 minutes before breakfast,for 16 weeks
16301940|NCT00633282|Drug|berberine|berberine tablet 0.5g tid,30 minutes before each meal,for 16 weeks
16301941|NCT00633269|Drug|AZD2281|100mg Oral Dose
16301942|NCT00633256|Drug|Cycloserine|50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.
16301943|NCT00633256|Drug|Placebo|Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
16301944|NCT00633243|Procedure|Modified Directly Observed Therapy (mDOT)|
16301945|NCT00633243|Procedure|Self-Administered Therapy (SAT)|
16301946|NCT00633230|Drug|standardized herbal formula, Sho-saiko-to (SST)|3 capsules containing 700 mg of the Sho-saiko-to (SST) herbal extract/capsule and 28 mg of the excipients, magnesium stearate, and silicon dioxide/capsule 2 x day
16301947|NCT00633230|Other|placebo capsule identical to the active herbal formula|3 placebo capsules 2 x day
16301948|NCT00633217|Drug|Fluticasone Propionate/Salmeterol DISKUS 250/50mcg|treatment drug
16301949|NCT00633217|Drug|Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg|treatment drug
16301950|NCT00633204|Biological|MPHOSPH1 and DEPDC1|DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week after curative surgery 8 times and BCG in bladder simultaneously. Then, DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered once every month. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
16301951|NCT00633191|Drug|Anti-pseudomonas IgY gargle|Gargle (solution), > 5FKU, every night after toothbrushing, life-long
16301952|NCT00633178|Behavioral|Group interpersonal therapy (IPT)|Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.
16301953|NCT00633178|Behavioral|Treatment as usual (TAU)|TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.
16301954|NCT00633165|Drug|Brostallicin|Patients will receive Brostallicin administered intravenously (IV) over 10 minutes at a dose of 10 mg/m2 on day one of a 21-day cycle. Safety and efficacy will be closely monitored and assessed.
16301955|NCT00633152|Drug|ceftaroline|600 mg injected every 12 hours for at least 5 but not more than 14 days
16301956|NCT00633152|Drug|linezolid|600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
16301957|NCT00633152|Drug|Aztreonam|1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
16301958|NCT00633139|Biological|Recombinant human Arylsulfatase A (rhASA)|intravenous infusion, every other week for 26 weeks
16301959|NCT00633126|Drug|ceftaroline|Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
16301960|NCT00633113|Procedure|MPPA|- Medial Parapatellar Arthrotomy
16301961|NCT00633113|Procedure|SV|- Subvastus Technique
16301962|NCT00633087|Drug|2-deoxyglucose|30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
16301963|NCT00633074|Biological|Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)|Intramuscular administration, 1 dose
16302362|NCT00630175|Drug|placebo|
16301964|NCT00633074|Biological|Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)|Intramuscular administration, 1 dose
16301965|NCT00633061|Drug|Enoxaparin|Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks.
16301966|NCT00633048|Drug|NSA-789|
16301967|NCT00633048|Drug|placebo|
16301968|NCT00633035|Drug|esomeprazole 40 mg|esomeprazole 40 mg po given for 7 days
16301969|NCT00633035|Drug|famotidine 20 mg|famotidine 20 mg intravenous bolus q12h for 7 days
16301970|NCT00633022|Drug|LOSMAPIMOD 7.5 MG|GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles.
16301971|NCT00633022|Drug|Placebo|Placebo tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised substance to visually match the active GW856553 tablets are also available. Tablets are packed into high-density polyethylene (HDPE) bottles.
16301972|NCT00633009|Biological|Leishmania tropica Skin Test Antigen (LtSTA)|Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction.
16301973|NCT00633009|Biological|Leishmania tropica Skin Test Antigen Placebo (Placebo)|Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo
16301974|NCT00632996|Other|Rehabilitation|Exercise, manual therapy, patient education, posture, home exercise program
16301975|NCT00632970|Drug|Raltegravir|1, 400mg tablet twice a day, with Truvada 1 tablet once a day
16301976|NCT00632970|Drug|Lopinavir/Ritonavir|2 tablets twice a day, with Truvada 1 tablet once a day
16301977|NCT00632970|Drug|Truvada|1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
16301978|NCT00632957|Dietary Supplement|Omega-3 Fatty acid (with SRP or OHI)|1000mg capsules three times daily, duration 28 weeks.
16301979|NCT00632957|Dietary Supplement|Placebo|corn/soybean oil capsules 1g/three times daily
16301980|NCT00632931|Drug|vorinostat|A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.
16301981|NCT00632931|Drug|Comparator: placebo (unspecified)|A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
16301982|NCT00632866|Drug|Hydroxychloroquine|Hydroxychloroquine : 200mg / day since 24 weeks
16301983|NCT00632866|Drug|Placebo|Placebo : 2cp/ day since 24 weeks
16301984|NCT00632853|Radiation|Standard Radiation Dose Therapy|45 Gy
16301985|NCT00632853|Drug|cisplatin|IV
16301986|NCT00632853|Drug|etoposide|IV
16301987|NCT00632853|Radiation|High Radiation Dose Therapy|70 Gy
16301988|NCT00632853|Drug|carboplatin|IV
16301989|NCT00632840|Drug|Atorvastatin and fenofibrate|atorvastatin (40mg/day) fenofibrate (200mg/day)
16301990|NCT00632827|Drug|Gemcitabine|Chemotherapy medication used to treat a number of types of cancer
16301991|NCT00632827|Drug|Navelbine|Navelbine is an chemotherapy medication used to treat a number of types of cancer
16301992|NCT00632827|Drug|Doxorubicin Hydrochloride Liposome Injection|Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug
16301993|NCT00632827|Drug|Granulocyte-colony stimulating factor (G-CSF)|G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
16301994|NCT00632827|Drug|Pegfilgrastim|Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF
16301995|NCT00632827|Drug|Cyclophosphamide|Cancer medication that interferes with the growth and spread of cancer cells in the body
16301996|NCT00632827|Drug|Vincristine|Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer
16301997|NCT00632827|Drug|Leucovorin|Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.
16301998|NCT00632827|Drug|Methotrexate|Methotrexate is a chemotherapy medication used to treat cancer
16301999|NCT00632827|Drug|Doxorubicin Hydrochloride|Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer
16302000|NCT00632827|Drug|Cytarabine|Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma
16302001|NCT00632827|Drug|Etoposide|Etoposide is a is a chemotherapy medication used to treat cancer
16302002|NCT00632827|Drug|Carmustine|Carmustine is a chemotherapy medication used to treat cancer
16302003|NCT00632827|Drug|Denileukin diftitox|Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells
16302004|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
16302005|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
16302363|NCT00630162|Genetic|amoeba|
16302006|NCT00632814|Drug|rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group
16302007|NCT00632801|Other|chewing gum|The patients in the gum chewing group (intervention group) will chew one stick of gum the first post-operative day, after the nasogastric tube is removed or if they patient does not have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set intervals
16302008|NCT00632788|Other|acute myocardial infarction checklist|For every patient fulfilling the criteria of enrollment, an acute myocardial infarction checklist was incorporated into the patient's medical records at emergency department immediately after a diagnosis of acute ST-elevation myocardial infarction was made. All the time sequences concerning different managements at different locations were recorded by nurses and/or physicians as instructions on the checklist.
16302009|NCT00632775|Drug|Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids|"Total daily fluid infusion equal to:
~100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg."
16302010|NCT00632775|Drug|Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids|"Total daily fluid infusion equal to:
~100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg."
16302011|NCT00632762|Drug|mantadix|dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
16302012|NCT00632749|Drug|BI 811283 (d 1 and 15)|BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle
16302013|NCT00632749|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
16302014|NCT00632749|Drug|BI 811283 (d1)|BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle
16302015|NCT00632749|Drug|Cytarabine|Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
16302016|NCT00632736|Drug|Ropinirole XL (formerly CR)|
16302017|NCT00632723|Drug|gefitinib (IRESSA™, ZD1839)|250 mg tablet; daily dose 500 mg daily
16302018|NCT00632710|Other|phototherapy|The laser used was low-level Aluminum Gallium Arsenide (AlGaAs)diodo laser, at a wavelength of 785 nm (infrared), dose of 3 J/cm2, mean power of 70 mW, 3 sec. per point, laser beam of 0,06cm2, BIOSET brand - Indústria de Tecnologia Eletrônica Ltda -Rio Claro, Brazil.
16302019|NCT00632710|Other|phototherapy placebo|disconnected laser (same device - experimental group)
16302020|NCT00632697|Drug|pentoxifylline|800 mg daily for six months
16302021|NCT00632697|Drug|placebo|
16302022|NCT00632684|Behavioral|Interviews with a single treatment planning session|Participants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities.
16302023|NCT00632684|Behavioral|Adaptive treatment model|The adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors.
16302024|NCT00632645|Drug|Olanzapine|Olanzapine Mylan oral dispersible form 5 to 10 mg / 2,5 à 20 mg per day
16302025|NCT00632645|Drug|Xenazine|Xenazine (tetrabenazine) tabs of 25mg , from 25 mg to 200 mg
16302026|NCT00632645|Drug|Tiapridal|Tiapridal (Tiapride), tabs 100 mg / from 300 to 800 mg per day
16302027|NCT00632632|Drug|D-Cycloserine|Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
16302028|NCT00632632|Other|Placebo|Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
16302029|NCT00632619|Behavioral|Group-based behavior therapy|Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
16302030|NCT00632619|Drug|Stimulant medication therapy|All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.
16302031|NCT00632619|Behavioral|Community-based psychosocial treatment|Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
16302032|NCT00632606|Drug|magnesium sulfate|magnesium sulfate 2 grams intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally
16302033|NCT00632606|Drug|metoclopramide|metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally
16302034|NCT00632593|Procedure|Laparoscopic Gastric Bypass|
16302035|NCT00632593|Procedure|Laparoscopic Gastric Bypass|
16302036|NCT00632580|Drug|intraarticular injection with ropivacaine|
16302037|NCT00632580|Drug|extraarticular injection with ropivacaine|
16302038|NCT00632567|Procedure|caesarean section|caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
16302039|NCT00632567|Procedure|vaginal delivery|vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
16302040|NCT00632554|Drug|prednisolone 0.5 mg/kg/day for three months|period of treatment
16302041|NCT00632554|Drug|prednisolone 0.5 mg/kg/day for six months|period of therapy
16302042|NCT00632541|Drug|Sorafenib|Sorafenib 200mg po daily
16302043|NCT00632541|Drug|Bevacizumab|"Bevacizumab 5mg/kg every other week
~1 Cycle = 4 weeks"
16302044|NCT00632541|Other|Imaging|Imaging every third cycle
16302045|NCT00632528|Drug|MEOPA|Administration of MEOPA gaz during postoperative physical therapy
16302046|NCT00632528|Drug|Medicinal air|Administration of medical air during postoperative physical therapy
16302455|NCT00629499|Drug|Cyclophosphamide|600 mg/m2 of IV cyclophosphamide
16302047|NCT00632515|Behavioral|Questionnaire|Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.
16302048|NCT00632502|Drug|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.
16302049|NCT00632502|Drug|Placebo|Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.
16302050|NCT00632502|Drug|Rescue medication|Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
16302051|NCT00632489|Drug|LBH589|LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
16302052|NCT00632489|Drug|Capecitabine|Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
16302053|NCT00632489|Drug|Lapatinib|Lapatinib, 1000 mg PO daily will be added to this combination.
16302054|NCT00632476|Other|Placebo|Placebo capsule once a day
16302055|NCT00632476|Dietary Supplement|Vitamin C|A 500-mg vitamin C capsule once a day
16302056|NCT00632463|Biological|RI-001|Dose 1
16302057|NCT00632463|Biological|RI-001|Dose 2
16302058|NCT00632463|Biological|RI-001|Placebo
16302059|NCT00632437|Procedure|Speckle-Contrast Imaging|Imaging camera scan that uses reflected red light to take pictures of the amount of blood flowing in brain and the amount of oxygen in blood.
16302060|NCT00632424|Drug|Ixabepilone (oral formulation)|Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity
16302061|NCT00632411|Drug|Nicotine Patch|"Participants who smoke more than 20 cigarettes per day will use a 21-mg patch for 4 weeks, a 14-mg patch for the next 2 weeks, a 7-mg patch for the next 2 weeks, and then no patch.
~Participants who smoke between 10 to 19 cigarettes per day will use a 14-mg patch for 4 weeks, a 7-mg patch for the next 4 weeks, and then no patch.
~Participants who smoke between 5 to 9 cigarettes per day will use a 7-mg patch for 8 weeks and then no patch.
~The proactive group will be given 8 weeks of patch treatment and the reactive group will be given 2 weeks of patch treatment."
16302062|NCT00632411|Behavioral|Tobacco Quit Line Program|"Phone session 1 will focus on smoking reduction.
~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days. Nicotine patches will be sent to participant with detailed instructions for patch use.
~Phone session 3 will focus on the first days after the quit date.
~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.
~Phone session 5 will focus on short-term relapse prevention.
~Phone session 6 will focus on long-term relapse prevention."
16302063|NCT00632398|Behavioral|Attention control (reading)|Caregivers read to the patient from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks
16302064|NCT00632398|Behavioral|Touch, Caring and Cancer DVD program|DVD- and manual-based instruction for caregivers and patients in the use of touch and massage techniques as supportive care in cancer, including: preparation for a session, safety precautions related to cancer and its treatments, communication about touch, centering to calm the mind; manual techniques for the head, neck, shoulders, back, feet and hands to promote relaxation; and acupressure for pain, nausea and anxiety.
16302065|NCT00632385|Drug|Eletriptan|40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
16302066|NCT00632372|Device|Cardiac Resynchronization Therapy|Pacing of the left ventricle to resynchronize ventricular contraction.
16302067|NCT00632372|Device|HeartPOD™ System|Left atrial pressure monitoring.
16302068|NCT00632359|Drug|Lenalidomide|10 mg daily given for 12 months
16302069|NCT00632333|Biological|URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil|Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.
16302070|NCT00632294|Procedure|Tissue Sample|A leftover sample of the removed allograft bone will be collected.
16302071|NCT00632281|Radiation|Stereotactic Body Radiation Therapy|Prescription dose: 48 Gy or 60 Gy RT
16302072|NCT00632268|Drug|RAD001; Cisplatin; 5-FU; Leucovorin|RAD001: oral 10mg/day on Day 1,8,15 Cisplatin:infusion 35mg/m2/day on Day 1,8 5-FU:infusion 2000mg/m2/day on Day 1,8,15
16302073|NCT00632255|Drug|Imatinib|Conventional therapy with imatinib
16302074|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min.
16302075|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 1.44 mg/kg given over 24 hours at a rate of 0.001 mg/kg/min.
16302076|NCT00632242|Drug|ARC1779|Initial stepwise infusion of 0.46 mg/kg over 30 minutes and subsequent continuous infusion of an additional 2.88 mg/kg given over 24 hours at a rate of 0.002 mg/kg/min.
16302077|NCT00632242|Drug|ARC1779|"Initial stepwise infusion of 0.23 mg/kg given over 30 minutes and subsequent continuous infusion of an additional 1.44 mg/kg given over 24 hours at a rate of 0.001 mg/kg/min to produce a target plasma concentration of 6 mcg/mL.
~Continuous infusion of ARC1779 Injection may continue for ≤ 14 days. After initial 24 hours dose may be titrated to achieve a target plasma concentration of 12 mcg/mL as needed, on the basis of clinical and laboratory data, according to the Investigator's judgment."
16302132|NCT00631774|Dietary Supplement|Glucerna SR|Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period.
16302203|NCT00631215|Procedure|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
16302078|NCT00632242|Drug|ARC1779|In one period of the sequence, ARC1779 will be administered to all subjects as a stepwise infusion of 0.23 mg/kg over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min in combination with a dummy 30-minute infusion of placebo. In another period, subjects will receive a single infusion of desmopressin at a dose of 0.4 mcg/kg given over 30 minutes in combination with a dummy 30-minute stepwise infusion followed by 4-hour continuous infusion of placebo. In the one other period, subjects will receive the combination of desmopressin at a dose of 0.4 mcg/kg given over 30 minutes and ARC1779 given as a stepwise infusion of 0.23 mg/kg over 30 minutes and subsequent continuous infusion of an additional 0.24 mg/kg given over 4 hours at a rate of 0.001 mg/kg/min
16302079|NCT00632229|Drug|Paliperidone|Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
16302080|NCT00632229|Drug|Placebo|Pill placebo taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
16302081|NCT00632216|Drug|Risedronate Sodium|
16302082|NCT00632203|Drug|Temozolomide|5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
16302083|NCT00632190|Other|fluorophotometry|
16302084|NCT00632190|Procedure|colposcopic biopsy|
16302085|NCT00632190|Procedure|colposcopy|
16302086|NCT00632190|Procedure|light-scattering spectroscopy|
16302087|NCT00632138|Behavioral|exercise intervention|
16302088|NCT00632138|Other|questionnaire administration|
16302089|NCT00632138|Procedure|biofeedback|
16302090|NCT00632138|Procedure|management of therapy complications|
16302091|NCT00632138|Procedure|psychosocial assessment and care|
16302092|NCT00632138|Procedure|quality-of-life assessment|
16302093|NCT00632125|Drug|HX575 recombinant human erythropoietin alfa|HX575 epoetin alfa i.v. will be administered according to the SmPC
16302094|NCT00632099|Drug|Oral micronized progesterone|Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
16302095|NCT00632099|Drug|Placebo|matched placebo
16302096|NCT00632086|Drug|PA32540|
16302097|NCT00632086|Drug|aspirin component of PA32540|The 325 mg aspirin component of PA32540
16302098|NCT00632086|Drug|Ecotrin|325 mg Ecotrin
16302099|NCT00632073|Drug|Vicriviroc|One tablet of vicriviroc maleate 30 mg once daily for 24 weeks (added to the subject's failing antiretroviral background regimen for 2 weeks, and then administered with optimized background therapy).
16302100|NCT00632060|Procedure|Manual / Manipulative Therapy (M/MT)|Subjects will receive M/MT twice a week for 4 weeks
16302101|NCT00632047|Other|active surveillance|
16302102|NCT00632047|Other|educational intervention|
16302103|NCT00632047|Procedure|examination|
16302104|NCT00632047|Procedure|long-term screening|
16302105|NCT00632034|Other|CD34+ haemopoietic stem cells|Expanded subset of CD34+ haemopoietic stem cell. Harvested from pelvic marrow aspiration at Day 0 of study. Undergoes refinement and minimum of 1000 fold expansion over 7 days in a dose escalation regime of a maximum dose of 1,000,000,000 cells in 5 millilitres. Injected at Day 7 via contralateral femoral artery under angiographic guidance. First regime up to 10,000,000 cells, second 100,000,000 cells, final regime maximum of 1,000,000,000 cells.
16302106|NCT00632021|Behavioral|Pharmacist Intervention for Low-Literacy in Cardiovascular Disease|Before hospital discharge, a pharmacist will provide medication reconciliation and counseling on how to take medications. Participants will receive a follow-up phone call 1 to 4 days after hospital discharge to discuss any medication problems, and additionally as needed.
16302107|NCT00632008|Drug|Soluble beta-glucan (SBG)|Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks
16302108|NCT00632008|Drug|Placebo comparator|Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.
16302109|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
16302110|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
16302111|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
16302112|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
16302113|NCT00631995|Biological|Meningococcal Polysaccharide Tetanus Protein Conjugate|0.5 mL, Intramuscular
16302114|NCT00631995|Dietary Supplement|Meningococcal polysaccharide group C conjugated|0.5 mL, Intramuscular
16302115|NCT00631982|Procedure|in vitro matuartion of oocytes|in vitro maturation of (immature) oocytes
16302116|NCT00631969|Drug|Vardenafil ODT (STAXYN, BAY38-9456)|Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
16302117|NCT00631969|Drug|Placebo|Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
16302118|NCT00631943|Drug|Pregabalin (Lyrica)|Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.
16302119|NCT00631917|Drug|Aliskiren|Aliskiren 300 mg once a day
16302120|NCT00631917|Drug|Ramipril|Ramipril 10 mg once a day
16302121|NCT00631917|Other|Placebo to Ramipril|Placebo capsules to match ramipril.
16302122|NCT00631917|Other|Placebo to Aliskiren|Placebo tablets to match aliskiren.
16302123|NCT00631878|Drug|Pagibaximab (formerly BSYX-A110)|Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
16302124|NCT00631865|Biological|Melanocyte transplantation|Injection of melanocytes directly in Epidermis
16302125|NCT00631852|Drug|American Ginseng root|four, 250mg tablets daily 5-14 days prior to surgery
16302126|NCT00631839|Radiation|Thoracic 3-D Conformal Radiotherapy|Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.
16302127|NCT00631813|Drug|Prucalopride|0.5 mg bid
16302128|NCT00631813|Drug|Prucalopride|1 mg bid
16302129|NCT00631813|Drug|Prucalopride|2 mg bid
16302130|NCT00631813|Drug|Placebo|bid
16302131|NCT00631800|Drug|Pagibaximab (formerly BSYX-A110)|Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14
16302602|NCT00628368|Genetic|polymorphism analysis|
16302133|NCT00631761|Other|educational workshop|The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas.
16302134|NCT00631761|Other|no intervention (usual resident activities)|usual activities
16302135|NCT00631748|Drug|quetiapine fumarate|At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 400 mg/day or alternatively 300, 200, 100, or 50 mg/day of study drug, as tolerated. If a subject is unable to tolerate the 50 mg/day dose, he or she will be discontinued from the drug portion of the study.
16302136|NCT00631748|Drug|Matched Placebo|Subjects randomized to the placebo comparator group will follow the same titration and dosing procedures as the experimental group, but will receive matched placebo tablets.
16302137|NCT00631748|Behavioral|Cognitive-behavioral Therapy|During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
16302138|NCT00631722|Drug|Quatiapine Fumarate|600-750mg/day
16302139|NCT00631722|Drug|Haloperidol|12-20mg/day
16302140|NCT00631709|Other|CareLink Remote Monitoring|Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits
16302141|NCT00631696|Drug|Pregabalin|pregabalin 600 mg given twice a day
16302142|NCT00631696|Drug|Placebo|Placebo
16302143|NCT00631670|Radiation|Stereotactic Body Radiation Therapy|15 Gy in one treatment
16302144|NCT00631670|Radiation|Stereotactic Body Radiation Therapy|Dose: 70 Gy at 2.8 Gy/treatment
16302145|NCT00631657|Drug|Esmirtazapine|One esmirtazapine 4.5 mg tablet once a day
16302146|NCT00631657|Drug|Placebo|One placebo tablet once a day
16302147|NCT00631631|Drug|Mifamurtide (L-MTP-PE)|Solution for intravenous infusion
16302148|NCT00631618|Drug|Sutent (sunitinib)|The initial dose will be 50mg daily taken for 4 consecutive weeks followed by 2-weeks off to comprise a complete cycle of 6 weeks.
16302149|NCT00631592|Drug|GSK1349572|
16302150|NCT00631579|Drug|Rasburicase (SR29142)|
16302151|NCT00631566|Drug|Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%|"BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).
~pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.
~Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days."
16302152|NCT00631566|Drug|Placebo|Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
16302153|NCT00631553|Drug|perflutren lipid microspheres|1.3 ml in 30 ml of saline, infused into vein at 2ml / min and titrated for optimal image quality (not to exceed 10 ml/ min at any time).
16302154|NCT00631540|Device|Formula Balloon-Expandable Stent|renal artery stenting
16302155|NCT00631527|Drug|Leuprolide|Injections given through a needle in the muscle every 3 months.
16302156|NCT00631527|Drug|Goserelin|Subcutaneous injections given once every 3 months.
16302157|NCT00631527|Drug|Sunitinib Malate|Starting dose of 12.5 mg by mouth daily for 4 weeks
16302158|NCT00631527|Drug|Casodex|Once a day by mouth for 2 weeks.
16302159|NCT00631527|Radiation|Radiation Therapy (RT)|Radiation treatment once daily over a period of 8 weeks.
16302160|NCT00631514|Drug|acetaminophen|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
16302161|NCT00631514|Drug|ibuprofen|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
16302162|NCT00631514|Drug|piroxicam|acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
16302163|NCT00631501|Drug|Placebo|
16302164|NCT00631501|Drug|Doxycycline|
16302165|NCT00631488|Drug|MK-0893|Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).
16302166|NCT00631488|Drug|Sitagliptin|Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
16302167|NCT00631488|Drug|Metformin|Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).
16302168|NCT00631488|Drug|Placebo for MK-0893|Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.
16302169|NCT00631488|Drug|Placebo for Sitagliptin|Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
16302170|NCT00631488|Drug|Placebo for Metformin|Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
16302171|NCT00631475|Drug|Bosentan|"For patients who were administered Bosentan during BUILD 3 (NCT00391443):
~continue on same dose
~For patients who were administered placebo during BUILD 3 (NCT00391443):
~Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.)"
16302172|NCT00631462|Drug|TG101348|Orally administered, once a day, for 28 days, up to 6 cycles.
16302173|NCT00631449|Drug|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.
16302202|NCT00631228|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease
16302174|NCT00631449|Drug|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
16302175|NCT00631410|Drug|sunitinib + mFOLFOX6|37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
16302176|NCT00631410|Drug|sunitinib + mFOLFOX6|50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
16302177|NCT00631397|Device|Ultrasound machine|Weekly Bone Density measurements using the Sonometer
16302178|NCT00631384|Behavioral|Couples VCT|Offer women coming to antenatal clinics to have their husbands come with them for couples VCT
16302179|NCT00631384|Behavioral|Individual VCT|Women to receive individual VCT
16302180|NCT00631371|Drug|Bevacizumab|Bevacizumab 10 mg/kg intravenous (IV) q8wks
16302181|NCT00631371|Drug|Temsirolimus|Temsirolimus 25 mg IV weekly
16302182|NCT00631371|Drug|Bevacizumab|Bevacizumab 10 mg/kg intravenous (IV) q8wks
16302183|NCT00631371|Drug|Interferon-Alfa 9MU|Interferon-Alfa 9MU SC TIW
16302184|NCT00631358|Drug|Maxidex|Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
16302185|NCT00631358|Other|No treatment|Healthy normal control group receiving no treatment
16302186|NCT00631345|Behavioral|Group-Based Lifestyle Intervention (Phases 1 and 2)|This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for the first 6-months of treatment (Phase 1) for a total weight loss of 5-7%. During Phase 2 (months 7-24) participants will be encouraged to continue weight loss as long as their BMI does not fall below 20 kg/m2, but the primary focus will be on weight maintenance. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
16302187|NCT00631345|Other|Individual Education Program (All Phases)|Comparison participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the RD will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle and will receive the lifestyle intervention manual and video series at the conclusion of their participation. These participants will be approached about the continuation at 24 months. If they agree to participate, these participants will continue to receive a monthly newsletter and will also receive biannual RD contacts.
16302188|NCT00631345|Behavioral|Self-Directed Maintenance (Phase 3)|Individuals from the lifestyle intervention group in the original HELP PD project who are randomized to self-directed maintenance will receive biannual nutrition counseling from the study RDs. In these sessions, the RD will cover basic aspects of transition from the group maintenance to individual maintenance, answer questions about healthy eating and activity to support weight loss, and discuss existing community resources that may fit the participants' needs as they attempt to maintain their weight loss, physical activity and dietary goals.
16302189|NCT00631345|Behavioral|Extended Group Maintenance (Phase 3)|The extended group maintenance condition will consist of monthly CHW-led group meetings, monthly individual telephone contacts with the CHW, biannual RD contacts, and other contacts as needed. During Phase 3, the objectives for Phase 2 of the initial program will be continued. That is, participants who were successful at weight loss (≥ 7% of initial body weight) are encouraged to either maintain their weight loss or to advance towards their own personal goals. Participants who were not successful are encouraged to problem solve the reasons for lack of success. The groups will focus on maintaining the healthy behaviors that produced weight loss and/or problem solving to overcome barriers to weight loss.
16302190|NCT00631319|Drug|OROS hydromorphone|hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
16302191|NCT00631319|Drug|Placebo|Placebo
16302192|NCT00631293|Dietary Supplement|lactisole|administration of lactisole followed by placebo
16302193|NCT00631293|Other|placebo|administration of placebo followed by lactisole
16302194|NCT00631280|Behavioral|Choice|Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a decision aid. Parent treatment preferences will be elicited and parents will receive coaching in deliberation about striking a balance between benefit and tolerable side effects. Parent will then choose the week that was best for their child and plan their next steps. Parents will also receive a consultation report that contains a physician dosage recommendation.
16302195|NCT00631280|Behavioral|Recommendation|Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a consultation report that also contains a physician dosage recommendation.
16302196|NCT00631267|Procedure|Manual Manipulation|The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
16302197|NCT00631267|Procedure|Finger Trap Traction|Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.
16302198|NCT00631254|Procedure|Allergen challenge|"Conventional allergen challenge: increasing allergen doses given by nebulisation through the mouth and stopped when a 20% fall in forced expiratory volume in one second is obtained.
~Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second.
~Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa."
16302199|NCT00631254|Procedure|Allergen challenge|"Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second.
~Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa."
16302200|NCT00631241|Procedure|Single Photon Emission Computed Tomography|First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.
16302201|NCT00631241|Procedure|Intraoperative Lymphatic Mapping|Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
16302204|NCT00631202|Drug|Epoetin alfa|Patients that will satisfy all inclusion/exclusion criteria will be sequentially treated with three single Epoetin alfa administrations. The first time the dose will be 600U/KG BW s.c. in a single administration. The outcome measures will be assessed. A washout period of 1 month will be necessary to eliminate any carry-over effect. A second administration of 1200U/KG BW s.c. will be performed. Outcome measures will be again assessed.
16302205|NCT00631189|Drug|Rosuvastatin|5mg oral
16302206|NCT00631189|Drug|Pravastatin|40mg oral
16302207|NCT00631189|Drug|Atorvastatin|10mg oral
16302208|NCT00631176|Behavioral|Just-In-Time Training|On-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function.
16302209|NCT00631163|Drug|Deferasirox (ICL670)|The recommended initial daily dose of Deferasirox is 20 mg/kg body weight.
16302210|NCT00631150|Drug|Levetiracetam (Keppra)|
16302211|NCT00631137|Drug|testosterone gel applied to skin|Application of testosterone gel
16302212|NCT00631137|Dietary Supplement|whey powder protein|
16302213|NCT00631124|Drug|BAY86-4891 (Estradiol / Drospirenone)|Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
16302214|NCT00631124|Drug|BAY86-4891 (Estradiol / Drospirenone)|Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
16302215|NCT00631111|Drug|effervescent ibuprofen tablets|
16302216|NCT00631111|Drug|effervescent Aspirin plus Vitamin C tablets|
16302217|NCT00631111|Drug|ibuprofen tablets|
16302218|NCT00631111|Drug|placebo|
16302219|NCT00631098|Procedure|venous cannulation|External jugular and cubital vein cannulation
16302220|NCT00631085|Drug|gamma tocopherol|Maxi Gamma softgels 1200mg QD
16302221|NCT00631072|Biological|INKT|Administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.
16302222|NCT00631072|Drug|GM-CSF|Given subcutaneously once daily for 10 days beginning the second day of the second and third infusion
16302223|NCT00631059|Other|Hem(A)+ Technology|The purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology.
16302224|NCT00631046|Dietary Supplement|Fish Oil|Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
16302225|NCT00631046|Dietary Supplement|Sunflower Oil|Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
16302226|NCT00631033|Drug|Placebo|
16302227|NCT00631033|Drug|Diazoxide|
16302228|NCT00631033|Drug|Metformin + Diazoxide|
16302229|NCT00631020|Behavioral|CBME|6 weeks of once a week one-on-one CBME
16302230|NCT00631020|Drug|Optional NRT|NicoDerm CQ nicotine transdermal patch
16302231|NCT00631007|Drug|INT131 besylate|Once-daily, oral
16302232|NCT00631007|Drug|Pioglitazone HCl|Once-daily, oral
16302233|NCT00631007|Drug|Placebo|Once-daily, oral
16302234|NCT00630994|Drug|Dacogen|
16302235|NCT00630981|Behavioral|Psychotherapy|Specific psychotherapy for dissociative disorders
16302236|NCT00630981|Drug|Pharmacological treatment (Quetiapine and/or Escitalopram)|Quetiapine for psychotic symptoms/Escitalopram if depressive disorders
16302237|NCT00630968|Drug|Levetiracetam (Keppra)|
16302238|NCT00630955|Drug|memantine|Memantine 20 mg once per day for 7 days
16302239|NCT00630955|Drug|Memantine|Memantine 40 mg once per day for 7 days
16302240|NCT00630955|Drug|Placebo|Placebo once per day for 7 days
16302241|NCT00630942|Drug|Minocycline|Minocycline 100 mg capsules twice a day before breakfast and before dinner.
16302242|NCT00630929|Drug|Ibuprofen|800 mg oral tablet 3 times daily with meals for 6 weeks
16302243|NCT00630929|Drug|Placebo|Matched placebo orally for 6 weeks
16302244|NCT00630929|Drug|Celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
16302245|NCT00630916|Device|Mitroflow Aortic Heart Valve|Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
16302246|NCT00630903|Drug|PUVA (8MOP + UVA) + IFN|Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)
16302247|NCT00630903|Drug|PUVA (8-MOP + UVA)|Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
16302248|NCT00630890|Radiation|External beam radiation and Cyberknife radiosurgery boost and capecitabine|External Beam Radiation to 45 Gy Stereotactic Body Radiotherapy with Cyberknife to 20 Gy in 5 fractions dose escalation to 25 Gy in 5 fractions, and then 30 Gy in 5 fractions Capecitabine 825 mg/m2 q12 hours taken orally 5 days per week
16302249|NCT00630877|Drug|Niacin extended-release (NER)|Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg
16302250|NCT00630877|Drug|Niacin extended-release (NER) placebo|Tablets administered once daily for 6 weeks
16302251|NCT00630877|Drug|Aspirin (ASA)|Tablets (325 mg) administered once daily for 6 weeks
16302252|NCT00630877|Drug|Aspirin (ASA) placebo|Tablets administered once daily for 6 weeks
16302253|NCT00630864|Drug|Fx-1006A|During Part 1, patients will receive Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for two weeks. During Part 2, patients will receive Fx-1006A 20mg soft gelatin capsules once daily to complete a total of 12 months of dosing
16302254|NCT00630851|Drug|Donepezil (Aricept)|Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
16302255|NCT00630851|Drug|Placebo|Matching placebo tablets orally once daily for 6 months
16302256|NCT00630838|Drug|VSL#3|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.
~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
16302257|NCT00630838|Drug|Placebo|Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months
16302258|NCT00630825|Drug|LY2189265|
16302259|NCT00630825|Drug|Placebo|
16302260|NCT00630812|Drug|inhaled mannitol|400 mg BD for 26 + 26 weeks
16302261|NCT00630812|Drug|Placebo comparator|BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
16302262|NCT00630799|Drug|leuprolide acetate|17 mg i.m.
16302263|NCT00630786|Drug|Panitumumab|Administered by intravenous infusion
16302264|NCT00630786|Drug|Conatumumab|Administered by intravenous infusion
16302265|NCT00630760|Drug|NRX 194204|NRX 194204 capsules given 3mg/m2 daily x 28 days. Repeated until PD
16302266|NCT00630747|Biological|Idursulfase|Solution for intravenous infusion, 0.5 mg/kg once-weekly
16302267|NCT00630734|Drug|Pravastatin|Pravastatin 40 mg by mouth daily on days 1-4
16302268|NCT00630734|Drug|Darunavir|Darunavir 600mg by mouth twice daily on days 12-18
16302269|NCT00630734|Drug|Ritonavir|Ritonavir 100mg by mouth twice daily on days 12-18
16302270|NCT00630734|Drug|Pravastatin|Pravastatin 40 mg by mouth daily on days 15-18
16302271|NCT00630734|Other|Washout|Washout (no medication) on days 5-11.
16302272|NCT00630721|Other|IFNbeta-1b|no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.
16302273|NCT00630708|Drug|Benazepril|20 mg per day
16302274|NCT00630708|Drug|Losartan|100 mg per day
16302275|NCT00630708|Drug|Benazepril+Losartan|combination treatment of 10 mg benazepril and 50 mg losartan per day
16302276|NCT00630695|Drug|Lanreotide LP 90|Lanreotide LP 90
16302277|NCT00630695|Drug|Placebo lanreotide|Placebo
16302278|NCT00630682|Drug|Dextroamphetamine|1 week placebo and 8 weeks 60mg d-AMP QD.
16302279|NCT00630682|Drug|Placebo|9 weeks of placebo 60mg capsules QD.
16302280|NCT00630669|Procedure|Rubber band ligation|placing rubber bands around the internal hemorrhoids
16302281|NCT00630669|Procedure|Bipolar coagulation|using electricity to cauterize
16302282|NCT00630656|Drug|Talactoferrin alfa|15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
16302283|NCT00630656|Drug|Placebo|Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
16302284|NCT00630643|Biological|NI-0401 (anti-CD3 mAB)|0.05 mg up to 10 mg
16302285|NCT00630643|Drug|Placebo|Placebo
16302286|NCT00630630|Drug|Levetiracetam|
16302287|NCT00630630|Other|Placebo|
16302288|NCT00630617|Behavioral|Diet, Physical activity, Physical inactivity|Community based participatory research design
16302289|NCT00630591|Behavioral|Standardized Materials Group|7 sets of print materials will be mailed every 6-7 weeks. A short survey about the information received and how useful it was will be completed.
16302290|NCT00630591|Behavioral|Independent Tailored Intervention|Personalized notebooks and newsletters of diet and exercise information will be mailed. A short survey about the information received and how useful it was will be completed.
16302291|NCT00630591|Behavioral|Partner-Assisted Tailored Intervention|Daughters and Mothers, as a team, will each receive personalized notebooks and newsletters of diet and exercise information. A short survey about the information received and how useful it was will be completed.
16302292|NCT00630578|Behavioral|Cognitive Processing Therapy|Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
16302293|NCT00630565|Biological|sargramostim|Given subcutaneously (SC) 10 μg/kg/day from day +3 until apheresis is completed
16302294|NCT00630565|Drug|busulfan|4 mg/kg po in 4 divided doses (.8 mg/kg/dose orally every 6 hours) on days -7 through -4.
16302295|NCT00630565|Drug|cyclophosphamide|4 gm/m^2 x 1 (day 0) and 60 mg/kg intravenous (IV) over 2 hours on days -3 and -2.
16302296|NCT00630565|Drug|dexamethasone|20 mg/m^2 x 4 doses every 12 hours given intravenously (IV) push before cytoxan on day 0 and then every 12 hours
16302297|NCT00630565|Drug|etoposide|300 mg/m^2/day x 2 days (day 0-1) over 3 hours intravenously (IV)
16302298|NCT00630565|Procedure|bone marrow transplantation|Day 0 infusion of bone marrow cells
16302299|NCT00630565|Procedure|hematopoietic stem cell transplantation|Stem cell infusion (>48 hours after the last dose of cyclophosphamide)
16302300|NCT00630565|Procedure|peripheral blood stem cell transplantation|Day 0 infusion of peripheral blood stem cells
16302301|NCT00630565|Radiation|total-body irradiation|165 cGy/dose given twice a day on days -7 through -4.
16302302|NCT00630552|Other|Placebo|Inactive dummy of AMG 655.
16302303|NCT00630552|Drug|AMG 479|AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
16302304|NCT00630552|Drug|AMG 655|AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
16302305|NCT00630539|Drug|Placebo|1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
16302306|NCT00630539|Drug|Ospemifene 5 mg|1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
16302307|NCT00630539|Drug|Ospemifene 15 mg|1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
16302308|NCT00630539|Drug|Ospemifene 30 mg|1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
16302309|NCT00630513|Drug|Ertapenem|3 days regimen with Ertapenem (1 g/day i.v.)
16302310|NCT00630513|Drug|Ampicillin-Sulbactam|3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
16302311|NCT00630500|Drug|Memantine|Tablets, 5 or 10 mg, twice daily
16302312|NCT00630500|Drug|Placebo|Tablets corresponding to 5 or 10 mg, twice daily, 6 months
16302359|NCT00630188|Other|Reducing Your Risks in the Crash|Publicly available video on highway safety and reducing individual risks in a crash
16302360|NCT00630175|Drug|zolpidem-MR (modified release)|
16302313|NCT00630487|Drug|Placebo|Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.
16302314|NCT00630487|Drug|Somatropin|Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.
16302315|NCT00630474|Drug|xylometazoline|xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril
16302316|NCT00630461|Biological|Clinical Center Reference Endotoxin|single inhalation challenge
16302317|NCT00630435|Drug|Premarin®/MPA formulation A|
16302318|NCT00630435|Drug|Premarin®/MPA formulation B|
16302319|NCT00630435|Drug|Premarin®/MPA formulation C|
16302320|NCT00630435|Drug|Premarin®/MPA currently marketed product|
16302321|NCT00630409|Drug|Gemcitabine|800 mg IV day 1 and 8
16302322|NCT00630409|Drug|Doxil|24 mg/m2 every 21 days IV
16302323|NCT00630396|Drug|Minocycline|"Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.
~Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.
~Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.
~Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses"
16302324|NCT00630383|Biological|Live Hookworm Larvae|25 live hookworm will be applied to the arm and will infect transdermally. They will be eradicated after 48 weeks.
16302325|NCT00630383|Other|Histamine|0.01% histamine solution is pipetted onto a plaster dressing.
16302326|NCT00630370|Drug|Placebo|2 Placebo tablets, TID, orally, 58 days
16302327|NCT00630370|Drug|20 mg ATI 7505|1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days
16302328|NCT00630370|Drug|40 mg ATI 7505|1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days
16302329|NCT00630370|Drug|80 mg ATI 7505|2 ATI 40mg tablets, TID, orally, 58 days
16302330|NCT00630357|Drug|Levetiracetam (Keppra)|
16302331|NCT00630344|Drug|RAD001|
16302332|NCT00630344|Drug|Bicalutamide|
16302333|NCT00630331|Biological|Cell culture-derived influenza vaccine|One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
16302334|NCT00630331|Biological|Egg-derived influenza virus vaccine|One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
16302335|NCT00630331|Biological|Placebo|One dose (0.5 mL) of phosphate buffered solution.
16302336|NCT00630318|Device|MRI|15-20 minutes MR imaging
16302337|NCT00630305|Device|alphafilcon A toric|Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
16302338|NCT00630305|Device|lotrafilcon B toric|Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
16302339|NCT00630305|Device|senofilcon A toric|Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
16302340|NCT00630292|Other|Magnetic Resonance Angiography (MRA) of the Breast|Magnetic Resonance Angiography (MRA) of the breast will be performed before or after pre-treatment magnetic resonance imaging (MRI) and then once again before or after the post-treatment MRI.
16302341|NCT00630279|Drug|Placebo|Placebo
16302342|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 150 mg/d, 7 days treatment
16302343|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 300 mg/d, 7 days treatment
16302344|NCT00630279|Drug|Recombinant Microbial Lipase SLV339|oral, 600 mg/d, 7 days treatment
16302345|NCT00630266|Device|CorCap CSD|The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.
16302346|NCT00630253|Biological|Anti-Thymocyte Globulin|30 mg/kg/day will be administered after MP on days -6, -5, -4, -3 and -2.
16302347|NCT00630253|Drug|Cyclophosphamide|5 mg/kg is to be given as a 2 hour infusion, Days -6 through -3.
16302348|NCT00630253|Drug|Fludarabine|35 mg/m^2 intravenously (IV) on days -6 through -2.
16302349|NCT00630253|Procedure|Hematopoietic Stem Cell Transplantation|Bone marrow or umbilical cord blood infusion on day 0.
16302350|NCT00630253|Drug|Methylprednisolone|Methylprednisolone (MP) 2 mg/kg/day intravenously every 24 hours will be given from day -6 until day -2 as a premedication for ATG.
16302351|NCT00630253|Drug|Filgrastim|5 mcg/kg per day intravenously (IV) continue until Absolute neutrophil count > or = 2.5 x 10^9/L
16302352|NCT00630253|Drug|Cyclosporine|Cyclosporine IV over 2 hours or orally every 8-12 hours beginning on day -3 and continuing until day 100, followed by a taper.
16302353|NCT00630253|Drug|Mycophenolate Mofetil|Day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute GVHD. Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours PO (to a maximum dose of 1 gram).
16302354|NCT00630227|Biological|Biologic Lung Volume Reduction|20 mL Hydrogel
16302355|NCT00630214|Dietary Supplement|Oral calcium plus vitamin D|calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.
16302356|NCT00630214|Dietary Supplement|Oral calcium alone|calcium carbonate (3 g/day, 1 g every 8 h)
16302357|NCT00630201|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
16302358|NCT00630188|Other|You Decide|"For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician
~For Physicians: a one-time educational session on prostate cancer and the value of shared decision making"
16302364|NCT00630149|Drug|Pemetrexed (Alimta)|500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
16302365|NCT00630136|Behavioral|interview|The parent/LAR who has consented to have their child undergo an outpatient endoscopy procedure will be interviewed prior to the procedure being performed.
16302366|NCT00630110|Drug|docetaxel|docetaxel (75 mg/m2)
16302367|NCT00630110|Drug|NPI-2358 + docetaxel|NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
16302368|NCT00630097|Drug|modafinil|Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
16302369|NCT00630084|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16302370|NCT00630084|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16302371|NCT00630058|Drug|MP-424(H), PEG-IFN-a-2b, RBV|MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
16302372|NCT00630058|Drug|MP-424 (L), PEG-IFN-a-2b, RBV|MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
16302373|NCT00630045|Drug|neoadjuvant chemotherapy with oxaliplatin and capecitabine|oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
16302374|NCT00630045|Procedure|resection of liver metastasis|surgery with the aim of R0 resection
16302375|NCT00630032|Drug|cyclophosphamide|500 mg/m² every 3 weeks
16302376|NCT00630032|Drug|Docetaxel|100 mg/m² every 3 weeks
16302377|NCT00630032|Drug|epirubicin hydrochloride|100 mg/m² every 3 weeks
16302378|NCT00630032|Drug|fluorouracil|500 mg/m² every 3 weeks
16302379|NCT00630032|Drug|ixabepilone|40 mg/m² every 3 weeks
16302380|NCT00630019|Drug|1.5% levofloxacin ophthalmic solution|Topical application
16302381|NCT00630019|Drug|0.5% moxifloxacin hydrochloride ophthalmic solution|Topical application
16302382|NCT00630006|Genetic|TNF-alpha and IL-10|
16302383|NCT00629993|Behavioral|Academic Detailing|It will involve multiple intervention components, some of which are standardized across physicians (i.e., self learning packets, post-tests for CME credit, CD-ROMS, videos, newsletters, culturally sensitive patient education materials, office staff informational sessions, chart and patient reminders, and a general office routine for cervical cancer counseling, including performance feedback, as well as media-ready materials). Academic detailing and the specific office routines will be customized to each physician, although the frequency of the detailing visits will be routinized across all participants, to reduce cost and to maximize its potential for dissemination.
16302384|NCT00629980|Drug|AzaSite®|ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
16302385|NCT00629967|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks
16302386|NCT00629967|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16302387|NCT00629941|Drug|AzaSite®|Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
16302388|NCT00629928|Drug|Esomeprazole|20mg oral capsule daily
16302389|NCT00629928|Drug|Esomeprazole|40mg oral capsule daily
16302390|NCT00629928|Drug|Placebo|
16302391|NCT00629889|Drug|levetiracetam|"After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg.
~Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study."
16302392|NCT00629889|Drug|pregabalin|"After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg.
~Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study."
16302393|NCT00629876|Drug|Peginesatide|"Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles.
~Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen."
16302394|NCT00629863|Drug|cisplatin|
16302395|NCT00629863|Drug|fluorouracil|
16302396|NCT00629863|Other|questionnaire administration|
16302397|NCT00629863|Procedure|diagnostic endoscopic procedure|
16302398|NCT00629863|Procedure|neoadjuvant therapy|
16302399|NCT00629863|Procedure|quality-of-life assessment|
16302400|NCT00629863|Procedure|therapeutic conventional surgery|
16302401|NCT00629863|Procedure|therapeutic endoscopic surgery|
16302402|NCT00629863|Procedure|ultrasound imaging|
16302403|NCT00629863|Radiation|radiation therapy|
16302404|NCT00629863|Radiation|radioisotope therapy|
16302405|NCT00629850|Device|Powerlung Performer|Inspiratory/Expiratory muscle trainer
16302406|NCT00629837|Biological|Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)|Low dose of BAY 79-4980 [13mg of liposomes/kg] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).
16302407|NCT00629837|Biological|Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)|High dose of BAY 79-4980 [22mg of liposomes/kg] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)
16302408|NCT00629837|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 [13mg of liposomes/kg]
16302409|NCT00629837|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 [22mg of liposomes/kg]
16302410|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
16302454|NCT00629499|Drug|nab paclitaxel|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
16302411|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
16302412|NCT00629824|Drug|pegylated interferon alpha and plus ribavirin|pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks
16302413|NCT00629811|Drug|Avotermin (Juvista)|"Intradermal avotermin administered to four wound sites per subject, one wound site per anatomically matched pair, according to the subject's assigned dose group:
~Group 1: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 1)
~Group 2: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 0)
~Each subject received four doses of active drug at concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site, one dose to one wound site per anatomically matched pair of wounds."
16302414|NCT00629811|Drug|Placebo|"Reference therapy was Placebo (vehicle). On Day 0, the four sites randomised to receive Placebo were administered with a 100μL intradermal injection of Placebo.
~Subjects in Group 2 were dosed again on Day 0 at 10 to 30 minutes after wound closure.
~Subjects in Group 1 were dosed again on Day 1 at 24 (+/-4) hours after initial administration of drug."
16302415|NCT00629798|Drug|Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant|Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days
16302416|NCT00629772|Drug|Placebo|Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.
16302417|NCT00629772|Drug|Infliximab|Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.
16302418|NCT00629759|Genetic|JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)|The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments.
16302419|NCT00629746|Device|Medtronic Xomed Nerve Integrity Monitor (NIM)|"patients receive surgery will be intubated with Medtronic Xomed NIM EMG endotracheal tube and the device will be connected to the monitoring system
~The channel leads from the NIM EMG reinforced endotracheal tube were connected to a NIM-response monitor
~A Prass monopolar probe was used in direct contact with the vagus nerve and RLN for laryngeal nerve stimulation.
~The stimuli were generated from the NIM-Response monitor for vagal and RLN stimulation.
~The NIM-response monitor was set to run with a 50 millisecond time window and an amplitude scale at 0.2 mV/division. Event capture was activated with a threshold at 100 μV. Peak to peak amplitudes of evoked EMG activities were directly read on the monitor screen."
16302420|NCT00629733|Drug|RO-14|
16302421|NCT00629720|Drug|alfuzosin (SL770499)|
16302422|NCT00629707|Other|intravenous fluid treatment|infusion of intravenous fluids (0.9% saline and 0.45% saline)
16302423|NCT00629694|Procedure|adenoidectomy, myringotomy, tubes insertion|adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
16302424|NCT00629694|Procedure|A-M|adenoidectomy and myringotomy alone
16302425|NCT00629681|Drug|Pregabalin|Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.
16302426|NCT00629668|Genetic|TNF-alpha and HBV genotype|
16302427|NCT00629668|Other|TNF-alpha and HBV genotypes|
16302428|NCT00629655|Other|motor task, sensory stimulation|"motor task: finger tapping, simple type and complex type
~sensory stimulation: electric or tactile stimulation"
16302429|NCT00629642|Drug|Solifenacin Succinate|Oral, 10mg
16302430|NCT00629642|Drug|Solifenacin Succinate|Oral, 5mg
16302431|NCT00629642|Drug|Oxybutynin Hydrochloride|Oral, 15mg
16302432|NCT00629642|Drug|Placebo|Oral
16302433|NCT00629629|Behavioral|Dietary Advice|
16302434|NCT00629616|Drug|anastrozole|1 mg/day for either 4 months or 6 months depending on the clinical evaluation
16302435|NCT00629616|Drug|fulvestrant|500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation
16302436|NCT00629603|Genetic|cytokine|polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
16302437|NCT00629603|Genetic|cytokine polymorphisms|Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
16302438|NCT00629603|Genetic|cytokine polymorphism|fibrosis-relating cytokine polymorphism
16302439|NCT00629590|Drug|AzaSite®|ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
16302440|NCT00629577|Genetic|microarray analysis|
16302441|NCT00629577|Other|flow cytometry|
16302442|NCT00629577|Procedure|biopsy|
16302443|NCT00629577|Procedure|colposcopy|
16302444|NCT00629564|Drug|Esomeprazole|20mg oral
16302445|NCT00629564|Drug|Esomeprazole|15 minute intravenous infusion
16302446|NCT00629551|Drug|saredutant (SR48968)|oral administration,capsules
16302447|NCT00629551|Drug|paroxetine|oral administration, capsules
16302448|NCT00629551|Drug|placebo|oral administration, capsules
16302449|NCT00629538|Procedure|Therapeutic thoracentesis|Thoracentesis was performed with drainage of 500 ml of pleural fluid first and every 200 ml thereafter until pleural pressure was lower than -20 cm H2O, chest discomfort developed, or no more pleural fluid could be removed.
16302450|NCT00629525|Drug|RAD001|RAD001 at a dose of 10 mg PO daily
16302451|NCT00629512|Drug|Esomeprazole|20mg oral daily
16302452|NCT00629512|Drug|Esomeprazole|40mg oral daily
16302453|NCT00629512|Drug|Placebo|
16302456|NCT00629499|Drug|Trastuzumab|8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.
16302457|NCT00629486|Genetic|Polymorphism of IL-1 beta and TNF-alpha|To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma
16302458|NCT00629473|Drug|NPI-0052 on Days 1, 8, 15 every 28 days|NPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles
16302459|NCT00629473|Drug|NPI-0052 on Days 1, 4, 8, 11 every 21 days|NPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles
16302460|NCT00629473|Drug|Dexamethasone|20 mg oral or IV day before and day after NPI-0052 dosing.
16302461|NCT00629447|Drug|Innohep|The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
16302462|NCT00629434|Other|diabetes education via telemedicine|This arm will receive diabetes group education via telemedicine
16302463|NCT00629434|Other|diabetes education in-person|In this arm the group of patients with diabetes will receive diabetes education in-person
16302464|NCT00629395|Behavioral|Captain's Log Computer Program|12 Computer Program
16302465|NCT00629382|Device|Polymyxin B immobilized fiber column|Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU.
16302466|NCT00629382|Other|Conventional medical therapy in the ICU|Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.
16302467|NCT00629369|Device|Extra 3 mouth guard, Shock doctor mouth guard v3.0|Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it.
16302468|NCT00629356|Genetic|dengue fever|
16302469|NCT00629343|Drug|Azacitidine In Combination With Temozolomide|mg, oral
16302470|NCT00629330|Behavioral|Academic Detailing|Multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients
16302471|NCT00629317|Other|Moisturizer|Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
16302472|NCT00629317|Drug|Methyl Aminolevulinate|Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
16302473|NCT00629304|Device|placebo|Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
16302474|NCT00629304|Device|VISITS + PDA-FIT system|patients will have face to face visits at 3 and 6 months + PDA-FIT system
16302475|NCT00629304|Device|PDA-FIT System + telephone follow-up|patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months
16302476|NCT00629278|Biological|trastuzumab|
16302477|NCT00629278|Drug|aromatase inhibition therapy|
16302478|NCT00629278|Drug|cyclophosphamide|
16302479|NCT00629278|Drug|docetaxel|
16302480|NCT00629278|Drug|doxorubicin hydrochloride|
16302481|NCT00629278|Drug|epirubicin hydrochloride|
16302482|NCT00629278|Drug|fluorouracil|
16302483|NCT00629278|Drug|paclitaxel|
16302484|NCT00629278|Drug|releasing hormone agonist therapy|
16302485|NCT00629278|Drug|tamoxifen citrate|
16302486|NCT00629278|Procedure|adjuvant therapy|
16302487|NCT00629278|Radiation|radiation therapy|
16302488|NCT00629265|Device|Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)|NMES or Sham NMES will be paired with repeated, effortful swallowing behavior, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
16302489|NCT00629252|Drug|Sertindole|oral 12-20 mg/day
16302490|NCT00629252|Drug|Risperidone|oral 2-6mg / day
16302491|NCT00629239|Drug|AZD4818|Dry Powder, inhalation, b.i.d., 4 weeks
16302492|NCT00629239|Drug|Placebo|
16302493|NCT00629226|Biological|cetuximab|Given IV
16302494|NCT00629226|Drug|bortezomib|Given IV
16302495|NCT00629226|Drug|cisplatin|Given IV
16302496|NCT00629226|Radiation|intensity-modulated radiation therapy|Once daily, 5 days a week, for up to 8 weeks
16302497|NCT00629213|Drug|acarbose|
16302498|NCT00629213|Drug|placebo|
16302499|NCT00629200|Drug|Sodium Stibogluconate|400 mg/m^2 IV daily on days 1-5.
16302500|NCT00629200|Drug|Interferon Alpha-2b|3x10^6 units subcutaneously three times weekly
16302501|NCT00629187|Drug|Temozolomide|Before taking part in this study, subjects will have stem cells collected in a procedure called apheresis. Once on this study, subjects will be admitted to the hospital and receive daily doses of temozolomide by mouth for 5 days. Stem cells will be given back to subjects who will remain in the hospital until blood counts have recovered. Doses of temozolomide will range from 350 mg to 1500 mg/m(squared) daily for 5 days (total dose 1750 to 7500 mg/m(squared).
16302502|NCT00629174|Behavioral|Exercise|Endurance and resistence training, 90 minutes, 3 times weekly
16302503|NCT00629174|Behavioral|Mental activity|Participation at computer lessons, 3 times weekly, 90 minutes each
16302504|NCT00629161|Drug|Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant)|12 months period of Traditional Chinese Medicinal Mixture per day plus 1 month wash-out period without herbal medicine
16302505|NCT00629161|Drug|placebo|12 months period of placebo plus 1 month period without placebo
16302506|NCT00629148|Drug|Vinorelbine and Capecitabine|Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
16302507|NCT00629148|Drug|Vinorelbine and Capecitabine|Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
16302603|NCT00628368|Other|laboratory biomarker analysis|
16302604|NCT00628368|Procedure|biopsy|
16302508|NCT00629135|Drug|Moxifloxacin/Metronidazole or Piperacillin/Tazobactam|Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
16302509|NCT00629122|Drug|Tacrolimus (Arm B)|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and clotrimazole troche x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, clotrimazole); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and clotrimazole troche x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subject by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
16302510|NCT00629122|Drug|Clotrimazole Troche|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and clotrimazole troche x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, clotrimazole); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and clotrimazole troche x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subject by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
16302511|NCT00629122|Drug|Tacrolimus (Arm A)|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and nystatin suspension x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, nystatin); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and nystatin suspension x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subjects by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
16302512|NCT00629122|Drug|Nystatin Suspension|Study day 1 (9a): Initiate sublingual (SL) tacrolimus and nystatin suspension x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, nystatin); Study day 5 (9p): End washout period; Study day 6 (9a): Initiate oral tacrolimus and nystatin suspension x 5 doses; Study day 8 (9a): Collection of pharmacokinetic parameters around the 5th oral tacrolimus dose; Study day 15: Contact subjects by telephone to assess for any adverse effects. To ensure that dietary intake does not affect the absorption profile of tacrolimus we will ensure that breakfast is given 15 minutes prior to drug administration on the days of pharmacokinetic assessment (study day 3 and 8).
16302513|NCT00629096|Procedure|Intracoronary infusion of autologous bone marrow cells|Autologous mononuclear bone marrow cells will be administered by intracoronary infusion via a percutaneous catheter
16302514|NCT00629083|Device|Bulkamid|Bulking injection with Bulkamid injection device
16302515|NCT00629083|Device|Contigen|Transurethral bulking injection
16302516|NCT00629070|Other|Traditional strength training|Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise)at 30 degrees/second; 6 sets of 5 maximum-effort concentric actions
16302517|NCT00629070|Other|Velocity-enhanced training|Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise). Subjects will perform 2 sets of 5 concentric exertions at 30°/second. The following 4 sets of 5 repetitions will be performed at a faster speed, starting at 60° /second. The velocity will be increased weekly in 15° /second increments up to a maximum of 120°/second.
16302518|NCT00629057|Biological|MVA-BN-PRO|1x10e8 TCID50 q 4 wks x 6
16302519|NCT00629057|Biological|MVA-BN-PRO|2 x 10e8 TCID50 q 4 wks x 6
16302520|NCT00629057|Biological|MVA-BN-PRO|4 x 10e8 TCID50 q 4 wks x 6
16302521|NCT00629044|Biological|Assessing the blood level of cholesterol 24 S Hydroxylase|Comparison of venous blood level of Cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma and AMD and in healthy subjects.
16302522|NCT00629044|Biological|Assessing the blood level of cholesterol 24 S hydroxylase|Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma, AMD end in healthy subjects
16302523|NCT00629044|Biological|assessing the blood level of cholesterol 24 S hydroxylase|Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with glaucoma, AMD and in healthy subjects
16302524|NCT00629031|Drug|Paromomycin|11 mg/kg for 14 days
16302525|NCT00629031|Drug|Paromomycin|Paromomycin for 21 days @ 11mg/kg by intramuscular injections
16302526|NCT00629018|Biological|CD34+ autologous stem cell transplantation|Peripheral blood stem cells will be mobilized by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labeled with technetium. Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment and the collected CD34+ cells will be injected intracoronary in the artery supplying the segments of reduced tracer accumulation
16302527|NCT00629018|Drug|Bone Marrow Stimulation|Patients will undergo filgrastim stimulation and viability assessment using the same protocol as in Arm 1. However, in this group, no intracoronary stem cell delivery will be performed; the patients will receive placebo (saline).
16302528|NCT00629018|Biological|SC therapy|In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect
16302529|NCT00629005|Behavioral|Constraint-Induced Movement Therapy + strength training|Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
16302605|NCT00628368|Procedure|endoscopic biopsy|
16302530|NCT00629005|Behavioral|Constraint-Induced Movement Therapy + range of motion|Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
16302531|NCT00628992|Other|No specific intervention, standard therapy serving as a control group, passive mobilization of the legs|Muscular rehabilitation of the leg
16302532|NCT00628992|Other|Electrical stimulation of the thigh|Muscular rehabilitation of the leg
16302533|NCT00628992|Other|Cycloergometer training|Muscular rehabilitation of the leg
16302534|NCT00628992|Other|Electrical stimulation of the thigh and cycloergometer training|Muscular rehabilitation of the leg
16302535|NCT00628979|Behavioral|CBT|cognitive- behavioral treatment for panic disorder.
16302536|NCT00628953|Drug|Esomeprazole|40mg twice a day
16302537|NCT00628953|Drug|Placebo|40mg twice a day
16302538|NCT00628940|Radiation|PET images with 18F-fluoromethylcholine|sequential PET images with 18F-fluoromethylcholine
16302539|NCT00628914|Drug|escitalopram and eszopiclone|escitalopram 10mg tabs QD and eszopiclone 3 mg tabs QD for 8 weeks
16302540|NCT00628914|Drug|Escitalopram, eszopiclone, and placebo|Escitalopram 10mg tabs QD for 8 weeks; Eszopiclone 3mg tabs QD for initial 4 weeks then placebo tabs QD for final 4 weeks
16302541|NCT00628914|Drug|Escitalopram|Escitalopram 10mg tabs QD and placebo tabs QD for 8 weeks
16302542|NCT00628901|Procedure|Uterine Fibroid Embolization (UFE)|Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.
16302543|NCT00628901|Device|Contour SE™ Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
16302544|NCT00628901|Device|Embosphere® Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
16302545|NCT00628888|Behavioral|Unified Protocol for Adolescents (UP-A)|All participants will be offered the UP-A intervention, inclusive of 8 and 21 weekly sessions of an emotion-focused treatment with cognitive-behavioral elements, either immediately following randomization or after an 8-week delayed treatment waitlist. The UP-A sessions are delivered in a flexible manner. Several of the UP-A's treatment elements are fixed and received by all participants (psychoeducation about emotions and emotional behavior, awareness and mindfulness skills, antecedent cognitive reappraisal/problem-solving skills, emotion exposure strategies, and relapse prevention skills), although applied for varying numbers of sessions depending on clinical need. Other strategies (motivational enhancement, parenting strategies and crisis management strategies) are applied on an as-needed basis based on client needs.
16302546|NCT00628862|Drug|Formoterol Turbuhaler® 4.5mg|4.5 mg inhaled twice daily
16302547|NCT00628862|Drug|Formoterol Turbuhaler® 9 mg|9 mg inhaled twice daily
16302548|NCT00628862|Drug|Turbuhaler® placebo|placebo inhaled twice daily
16302549|NCT00628836|Device|BION stimulation|"The study will have two phases, each with a six week duration. During phase 1, the BION group will be implanted with BIONs in the middle deltoid and supraspinatus muscles. The muscles will be stimulated electrically by way of the BION and an external controller for one to two hours per day at 5pps in an on-off duty cycle train. The SE group will begin surface stimulation similar to that of BE group.
~Subjects in either group whose initial therapy in phase 1 successfully reduces the amount of shoulder subluxation to 5mm or less will go off stimulation for six weeks, and be reassessed whether subluxation is redeveloping.
~If a subject in either group does not respond sufficiently to phase 1 therapy, the participant will move to phase 2 where the shoulder will be stimulated at up to 25 pps either with surface stimulation (SE group) or BION stimulation (BE group) for another six weeks. At the end of phase 2, participants will go off stimulation for six weeks and then be reevaluated."
16302550|NCT00628823|Dietary Supplement|Gluten-free diet|Gluten containing foods removed from diet
16302551|NCT00628810|Biological|bevacizumab|
16302552|NCT00628810|Drug|fluorouracil|
16302553|NCT00628810|Drug|irinotecan hydrochloride|
16302554|NCT00628810|Drug|leucovorin calcium|
16302555|NCT00628797|Radiation|UVA1|intraindividual half body irradiation
16302556|NCT00628797|Other|UVA1|60 J/cm2 at least 36 tx
16302557|NCT00628784|Procedure|Endoscopic spray cryotherapy|A special orogastric venting tube is passed alongside the endoscope and the cryocatheter then used to perform cryotherapy. Liquid nitrogen is sprayed through the catheter to achieve a uniform white frost in a hemicircumferential sector for 10 seconds. A thaw time of 45-60seconds is observed. This freeze-thaw cycle is repeated x 3 for a total of 40sec cryotherapy per segment. This therapy is repeated every 6 weeks until visible re-epithelialization is seen or a maximum of 6 sessions. Once a squamous lining is seen, biopsies are taken throughout the original area to assess for buried Barretts. If none is seen, followup with 4 quadrant q2cm biopsies are taken at 3,6,9,12, 18, 24, 36, 48 months.
16302558|NCT00628784|Procedure|Endoscopic spray cryotherapy|After passing a special orogastric venting tube, the cryocatheter is used to spray liquid nitrogen onto the tumor to achieve a white frost (frozen state) for 20 seconds. A 45-60 sec thaw is allowed and then retreatment x 2 for a total of 60 seconds therapy per session. Repeat treatments are permitted every 2 weeks for a maximum of 8 treatments.
16302559|NCT00628771|Behavioral|CenteringPregnancy Plus (CP+)|The CenteringPregnancy model of group prenatal care involves skill-building in the areas of efficacy, risk assessment, negotiation, and prevention. CP+ integrates HIV prevention into prenatal care, builds on motivations for healthy pregnancy, and creates a sustainable model via reimbursement mechanisms for prenatal care. There will be ten 2-hour prenatal group sessions.
16302560|NCT00628771|Behavioral|Usual care|Usual care includes standard individual prenatal care and no prenatal group sessions.
16302561|NCT00628758|Drug|Symbicort TBH - Turbuhaler|Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
16302606|NCT00628355|Drug|lidocaine|Women randomized for this treatment was submitted to 2mL of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks
16303632|NCT00621452|Genetic|polymerase chain reaction|Correlative studies
16302562|NCT00628758|Drug|beta-II-agonist, inhale steroid|Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
16302564|NCT00628732|Drug|Cyclophosphamide and Topotecan|Two courses of cyclophosphamide at 50 mg/m2/dose and topotecan 0.8 mg/m2/dose by mouth every morning for 14 days each.
16302565|NCT00628719|Drug|Liposomal Amphotericin B|a single dose of 10 mg/kg of liposomal amphotericin B
16302566|NCT00628719|Drug|amphotericin B deoxycholate|amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
16302567|NCT00628706|Drug|Delta9-tetrahydrocannabinol (THC)|inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
16302568|NCT00628680|Device|AAT-023 solution (Zuragen)|Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
16302569|NCT00628680|Drug|Heparin|Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
16302570|NCT00628667|Drug|Esomeprazole|40mg orally twice daily
16302571|NCT00628667|Drug|Placebo|
16302572|NCT00628628|Drug|As Needed Rasburicase|.15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
16302573|NCT00628628|Drug|Fixed Dose Rasburicase|.15 mg/kg IV Over 30 Minutes Daily
16302574|NCT00628602|Device|BION|"30 patients operated will be randomized into 2 equal groups, a BION Therapy Group (Rx group) and a Control Group (Control group)."
16302575|NCT00628589|Drug|Inhaled loxapine 5 mg|Inhaled loxapine 5 mg
16302576|NCT00628589|Drug|Inhaled loxapine 10 mg|Inhaled loxapine 10 mg
16302577|NCT00628589|Drug|Inhaled placebo|Inhaled placebo
16302578|NCT00628576|Drug|unfractionated heparin|UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value
16302579|NCT00628576|Drug|Tinzaparin (Leo)|FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
16302580|NCT00628550|Drug|Vasopressin|One dose of vasopressin (0.8 units/kg) intravenously rescue as the second vasopressor medication.
16302581|NCT00628550|Drug|Epinephrine|One standard dose epinephrine (0.01 mg/kg) intravenously rescue as the second vasopressor medication.
16302582|NCT00628537|Device|BION stimulation|"BION™ Experimental Group
~The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion.
~Surface Stimulation Group
~Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.
~Control Group with conservative therapy (Range of motion exercises)
~The research participant is instructed in self-administered, standard range of motion stretching exercises."
16302583|NCT00628511|Device|ARES (Apnea Risk Evaluation System)|application of portable monitoring device with PSG
16302584|NCT00628498|Drug|Defibrotide|"Defibrotide is a single-stranded polydeoxyribonucleotide derived from porcine intestinal mucosa by controlled depolymerisation. Defibrotide has a complex mechanism of action with antithrombotic, anti-ischemic, anti-inflammatory, anti-adhesive and thrombolytic properties but no significant systemic anti-coagulant effects.
~Defibrotide is dose intravenously as a 2-hour infusion every 6 hours at a dose of 25 mg/kg/day. Recommended duration of therapy is 21 days."
16302585|NCT00628498|Drug|Defibrotide|
16302586|NCT00628485|Device|BION|"The second group will have a High Stimulation paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions. Stimulation intensity will be adjusted to produce the strongest contractions that are tolerated."
16302587|NCT00628485|Device|BION|"The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal twitch stimulation. The period of the stimulation will probably be short for the first sessions as the muscles gain strength and fatigue resistance, but will eventually be 60 minutes per day in two spaced sessions of about 30 minutes each."
16302588|NCT00628485|Device|BION|A third group of experimental subjects will have a standardized program of voluntary swallowing exercises. Their BIONs will not be activated until they have worsening of dysphagia, and thus are considered to have failed conventional therapy.
16302589|NCT00628472|Drug|botulinum type a|12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort
16302590|NCT00628459|Dietary Supplement|micronutrient supplementation|Supplements are given daily, 5days/week, for 6 months, involving 15 mg iron (arm 1), 15 mg iron and 10 mg zinc (arm 2), or multiple micronutrient (arm 3): 15 mg iron, 10 mg zinc, 375 µg vitamin A, 5 µg vitamin D, 6 mg vitamin E, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 150 µg folic acid, 0.5 mg vitamin B6, 0.9 mg vitamin B12, 35 mg vitamin C, 10 µg vitamin K, 50 µg iodine, 0.6 mg copper.
16302591|NCT00628433|Drug|Placebo|Placebo
16302592|NCT00628433|Drug|HE3286|daily for 28 days
16302593|NCT00628420|Drug|ACP-104|25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
16302594|NCT00628420|Drug|ACP-104|Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
16302595|NCT00628420|Drug|Placebo|patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.
16302596|NCT00628394|Drug|Atomoxetine|40mg 2po qam
16302597|NCT00628394|Drug|Placebo|40mg 2po qam
16302598|NCT00628381|Dietary Supplement|L-citrulline supplementation|L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
16302599|NCT00628381|Dietary Supplement|L-alanine|L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
16302600|NCT00628368|Genetic|gene expression analysis|
16302601|NCT00628368|Genetic|mutation analysis|
16302607|NCT00628355|Procedure|Ischemic compression|Women randomized for treatment with ischemic compression will be first subjected to transcutaneal electrostimulation(TENS) for 30 minutes on trigger point to inhibit the painful stimulation. For this will be used 100 Hertz of frequency and pulse of 250ms. The intensity will be varying according the painful threshold of each patient. After, the ischemic compression will be applied. For this we will use an algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. The therapy will be applied in trigger point three times (60 seconds each) with 30 seconds of rest between the applications.
16302608|NCT00628342|Drug|Esomeprazole|20mg Oral tablet once daily
16302609|NCT00628342|Drug|Esomeprazole|40mg Oral tablet once daily
16302610|NCT00628342|Drug|Placebo|Oral once daily
16302611|NCT00628316|Dietary Supplement|caffeine|caffeine daily intake will be reduced form 150 ml per day
16302612|NCT00628303|Biological|Motavizumab|15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
16302613|NCT00628303|Other|Placebo|15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
16302614|NCT00628290|Drug|Cannabidiol|Capsules, 3 times daily, 200 mg, 4 weeks
16302615|NCT00628290|Drug|Amisulpride|Capsules, 3 times daily, 200 mg, 4 weeks
16302616|NCT00628277|Behavioral|high caloric expenditure exercise|high caloric expenditure exercise plus dietary counseling
16302617|NCT00628277|Behavioral|low caloric expenditure exercise plus dietary counseling|low caloric expenditure exercise plus dietary counseling
16302618|NCT00628264|Drug|AP214|Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
16302619|NCT00628264|Drug|Placebo|Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
16302620|NCT00628251|Drug|AZD2281|400mg Oral twice daily
16302621|NCT00628251|Drug|Liposomal Doxorubicin|50mg/m2 Monthly Intravenous
16302622|NCT00628251|Drug|AZD2281|200mg oral twice daily
16302623|NCT00628238|Drug|Lenalidomide and Rituximab|Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.
16302624|NCT00628238|Drug|Lenalidomide and Rituximab|Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.
16302625|NCT00628225|Behavioral|Counseling and Nicotine replacement (CN)|"Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. General practitioners were encouraged to advise nicotine replacement.
~Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement."
16302626|NCT00628225|Behavioral|Counseling, Nicotine replacement and Bupropion (CNB)|"Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. The general practitioner was encouraged to advice the patients to use both nicotine replacements and Bupropion-SR.
~Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement and Bupropion-SR."
16302627|NCT00628212|Drug|Teneligliptin 10mg|
16302628|NCT00628212|Drug|Teneligliptin 20 mg|
16302629|NCT00628212|Drug|Teneligliptin 40 mg|
16302630|NCT00628212|Drug|Placebo|
16302631|NCT00628199|Procedure|Improving the scientific process of human cell reprogramming|
16302632|NCT00628186|Device|external drainage tube [polyethylene pancreatic drainage tube]|External drainage tube was intubated with a 5F polyethylene pancreatic drainage tube with a small knob (Sumitomo Bakelite Co., Japan)(MD41515) across pancreaticojejunostomy in pancreaticoduodenectomy, and exteriorized through the jejunal limb.
16302633|NCT00628186|Device|internal drainage tube [polyethylene pancreatic drainage tube]|Internal drainage tube was intubated 5cm length of stent tube cut a 5F polyethylene pancreatic drainage tube with a small knob across pancreaticojejunostomy in pancreaticoduodenectomy, and pancreatic juice was led to reconstructed jejunum.
16302634|NCT00628173|Procedure|AGV implantation|
16302635|NCT00628160|Drug|Terlipressin|Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
16302636|NCT00628160|Drug|alpha adrenergic drugs|Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
16302637|NCT00628147|Device|Narrow band imaging colonoscope|Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
16302638|NCT00628134|Drug|calfactant|single inhaled dose by nebulizer
16302639|NCT00628134|Drug|isotonic saline|single inhaled dose by nebulizer
16302640|NCT00628121|Drug|Cetrorelix|1, 2 or 3mg, subcutaneouly dosed with single dose
16302641|NCT00628108|Drug|Levocetirizine 1.25 mg|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
16302642|NCT00628108|Other|Placebo|Placebo oral liquid once a day for two weeks
16302643|NCT00628095|Drug|CE-224,535|500 mg po BID
16302644|NCT00628095|Drug|Placebo|no active ingredient
16302645|NCT00628056|Drug|Perhexiline|Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
16302646|NCT00628043|Drug|epoetin beta|Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
16302647|NCT00628043|Drug|placebo|Subcutaneous administration of placebo once-weekly for 12 weeks
16303633|NCT00621452|Genetic|gene rearrangement analysis|Correlative studies
16302648|NCT00628030|Behavioral|NOURISH|Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
16302649|NCT00628030|Other|Wellness Group|Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.
16302650|NCT00628017|Dietary Supplement|omega-3 polyunsaturated fatty acids ( EPA+DHA)|Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.
16302651|NCT00628004|Device|Biatain Ibu|Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
16302652|NCT00628004|Device|Local best practice|"N/A - since intervention is local best practice"
16302653|NCT00627991|Drug|Valsartan|
16302654|NCT00627978|Drug|ixabepilone|ixabepilone 40 mg/m2 Q3w over 3 hours
16302655|NCT00627965|Drug|Sildenafil citrate|50mg tds
16302656|NCT00627965|Drug|Placebo|Placebo tds
16302657|NCT00627952|Drug|amlodipine 10 mg|amlodipine 10 mg once daily
16302658|NCT00627952|Drug|manidipine 20 mg|manidipine 20 mg once daily
16302659|NCT00627952|Drug|amlodipine 5 mg + delapril 30 mg|amlodipine 5 mg + delapril 30 mg once daily
16302660|NCT00627952|Drug|manidipine 10 mg + delapril 30 mg|manidipine 10 mg + delapril 30 mg once daily
16302661|NCT00627926|Biological|Pegylated Interferon Alfa 2a|subcutaneous injection, 180 micrograms once per week
16302662|NCT00627926|Drug|Telaprevir|375 mg tablets administered orally every 8 hours at a dose of 750 mg
16302663|NCT00627926|Drug|Ribavirin|200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg
16302664|NCT00627926|Other|Placebo|Telaprevir matching placebo
16302665|NCT00627913|Procedure|Healon 5 injection|Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement.
16302666|NCT00627913|Procedure|Retrobulbar anesthetic injection|3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion.
16302667|NCT00627900|Device|bare metal stent|implantation of a bare metal stent
16302668|NCT00627900|Device|Cypher-Stent (Implantation of a sirolimus-eluting stent)|Implantation of a sirolimus-eluting stent
16302669|NCT00627887|Procedure|Electroconvulsive therapy|unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
16302670|NCT00627887|Drug|venlafaxine|extended release target dose of 300mg/day duration of one year
16302671|NCT00627887|Drug|Lithium|serum concentration 0,5-0,8 mmol/L, one year duration
16302672|NCT00627874|Device|+3D Lenses|wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
16302673|NCT00627861|Drug|Aliskiren|150mg orally daily for 6 weeks. Dose may increase to 300mg orally daily dependent upon blood pressure parameters set by the protocol.
16302674|NCT00627861|Drug|Extended-release metoprolol|50mg orally daily for 1 week, dose will increase to 100mg orally daily or decrease to 25mg daily for a second week dependent upon blood pressure parameters set by the protocol. Subjects will take metoprolol for a total of 2 weeks, then be tapered off of it over 5-7 days.
16302675|NCT00627848|Drug|rivastigmine|Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.
16302676|NCT00627835|Drug|sorafenib|Cohort 1 - sorafenib 200 mg PO bid concurrent with radiation
16302677|NCT00627835|Drug|sorafenib|o Cohort 2 - sorafenib 400 mg PO bid concurrent with radiation
16302678|NCT00627835|Drug|sorafenib and cisplatin|Cohort 3 - sorafenib 200 mg PO bid / cisplatin 75 mg/m2 weeks 1, 4 and 7
16302679|NCT00627835|Drug|sorafenib and cisplatin|o Cohort 4 - sorafenib 400 mg PO bid/ cisplatin 75 mg/m2 weeks 1, 4 and 7
16302680|NCT00627835|Drug|sorafenib and cisplatin|Cohort 5 - sorafenib 400 mg PO bid/ cisplatin 100 mg/m2 weeks 1, 4 and 7
16302681|NCT00627809|Drug|Streptokinase|intracoronary infusion, 250.000 Units
16302682|NCT00627809|Procedure|primary percutaneous coronary intervention|balloon catheter, stent
16302683|NCT00627796|Drug|Lanreotide-Autogel 120 mg|ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were > 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were < 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels <1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration.
16302684|NCT00627783|Other|a bicycle exercise test|
16302685|NCT00627770|Device|bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia|edema evaluation using bioimpedance
16302686|NCT00627744|Drug|Sitagliptin|BE 1 receives Placebo tablets od during 12 weeks BE 2 receives Sitagliptin tablets 100 mg od during 12 weeks
16302687|NCT00627731|Drug|methylprednisolone sodium succinate (mPSL)|mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
16302688|NCT00627731|Drug|prednisolone (PSL)|PSL 40 mg per day for 10 days
16302689|NCT00627718|Device|HRT screening for macula edema|HRT screening for macula edema at time of initial diagnosis of macular degeneration
16302690|NCT00627705|Drug|N-Acetyl Cysteine|"Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
~Entire intervention lasts for 12 weeks (drug administration is continuous)."
16302782|NCT00627094|Device|Biatain|A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
16302691|NCT00627705|Other|Placebo - sugar pill|"Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
~Entire intervention lasts for 12 weeks (drug administration is continuous)."
16302692|NCT00627692|Drug|Prucalopride|0.5 mg o.d.
16302693|NCT00627692|Other|Placebo|o.d.
16302694|NCT00627692|Drug|Prucalopride|1 mg o.d.
16302695|NCT00627692|Drug|Prucalopride|2 mg o.d.
16302696|NCT00627692|Drug|Prucalopride|4 mg o.d.
16302697|NCT00627679|Drug|Budesonide Inhalation Suspension|Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
16302698|NCT00627679|Drug|MAP0010 low dose|Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
16302699|NCT00627679|Drug|MAP0010 intermediate dose|Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
16302700|NCT00627679|Drug|MAP0010 high dose|Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
16302701|NCT00627666|Biological|anti-thymocyte globulin|
16302702|NCT00627666|Drug|busulfan|
16302703|NCT00627666|Drug|fludarabine phosphate|
16302704|NCT00627666|Drug|leucovorin calcium|
16302705|NCT00627666|Drug|methotrexate|
16302706|NCT00627666|Procedure|allogeneic bone marrow transplantation|
16302707|NCT00627666|Procedure|allogeneic hematopoietic stem cell transplantation|
16302708|NCT00627666|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16302709|NCT00627653|Drug|fenofibrate|148mg daily for 30 days
16302710|NCT00627640|Drug|Safinimide 50-100 mg/day|Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
16302711|NCT00627640|Drug|Matching Placebo|Matching Placebo
16302712|NCT00627627|Drug|IPI-504|dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle
16302713|NCT00627614|Other|breast imaging study|"1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging.
~2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure."
16302714|NCT00627588|Biological|ProSavin|ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
16302715|NCT00627588|Biological|ProSavin|ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
16302716|NCT00627575|Drug|lamotrigine|Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.
16302717|NCT00627575|Drug|atorvastatin|Atorvastatin will available as 40 mg tablets.
16302718|NCT00627575|Drug|phenytoin|Phenytoin will available as 100 mg capsules.
16302719|NCT00627562|Device|robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System|Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System
16302720|NCT00627549|Procedure|Avaulta (surgical procedure using a mesh implant)|The use of Avaulta
16302721|NCT00627549|Procedure|Conventional surgery (anterior repair)|Anterior repair surgery
16302722|NCT00627536|Drug|Avotermin|A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
16302723|NCT00627536|Drug|Placebo|Matched to avotermin dosage strength
16302724|NCT00627523|Drug|Genotropin (PN-180,307) Somatropin|Injectable Genotropin
16302725|NCT00627523|Drug|Control-no treatment|Control-no treatment
16302726|NCT00627510|Other|Routine psychiatric inpatient treatment|Routine psychiatric inpatient treatment. This is not an interventional study.
16302727|NCT00627497|Procedure|Single-Level Posterior Decompression|The single level posterior decompression is a posterior surgical procedure.
16302728|NCT00627497|Device|DIAM Spinal Stabilization|The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
16302729|NCT00627497|Device|DIAM Spinal Stabilization|The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
16302730|NCT00627497|Device|Fusion|Posterolateral Interbody Fusion
16302731|NCT00627484|Procedure|Gastric bypass|NOTE: the surgery is not paid for by the study
16302732|NCT00627484|Procedure|Gastric banding|NOTE: the surgery is not paid for by the study
16302733|NCT00627484|Procedure|Sleeve gastrectomy|NOTE: the surgery is not paid for by the study
16302734|NCT00627484|Behavioral|Very low calorie diet|Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
16302735|NCT00627471|Drug|Insulin Glargine|For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.
16302736|NCT00627471|Drug|Insulin Glargine|"In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician.
~For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic."
16302737|NCT00627458|Biological|Infanrix Hexa|Vaccine administered as a booster dose at 16-20 months of age
16302738|NCT00627445|Drug|biphasic insulin aspart 30|Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
16302739|NCT00627445|Drug|metformin|Tablets, 500 - 2000 mg, once, twice or three times daily
16302740|NCT00627445|Drug|biphasic insulin aspart 50|Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
16302741|NCT00627432|Drug|gemcitabine hydrochloride|
16302742|NCT00627432|Drug|oxaliplatin|
16302743|NCT00627419|Drug|IPI-504|Dose as a 30 to 60 minute IV infusion as part of a 21-day treatment cycle until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for patient withdrawal. IPI-504 will be administered twice weekly on Study Days 1, 4, 8, and 11 of each 21-day cycle.
16302744|NCT00627406|Drug|Buserelin and Pregnyl|Subcutaneous injection 0.5 mg and 1500 IU
16302745|NCT00627406|Drug|Pregnyl|Subcutaneous injection 5000 IU
16302746|NCT00627406|Drug|Buserelin and Pregnyl|Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
16302747|NCT00627406|Drug|Pregnyl|Subcutaneous injection 5000 IU
16302748|NCT00627393|Drug|Standard antimicrobial therapy|Antimicrobial therapy is broadly defined as therapy within the standard of care for a particular infection and should be consistent within a given institution. Participants will undergo the recommended therapy for specific infections for 42 days.
16302749|NCT00627393|Biological|Granulocyte transfusions|Participants will receive one granulocyte transfusion per day until one of the following occurs: recovery from neutropenia, life-threatening toxicity, resolution or improvement of infection, or Day 42 after treatment. Granulocyte content of each transfusion is targeted to be at least 4 x 10^10 per collection (or proportionately less for participants less than 30 kg in weight).
16302750|NCT00627393|Drug|G-CSF/dexamethasone|Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.
16302751|NCT00627393|Device|Apheresis machine|Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.
16302752|NCT00627380|Behavioral|Yoga lifestyle intervention|Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions.
16302753|NCT00627380|Other|Standard of care|Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
16302754|NCT00627367|Drug|Hydromorphone|Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
16302755|NCT00627367|Drug|Nonprotocolized|An IV opioid the type and dose of which will be determined by the treating clinician
16302756|NCT00627354|Drug|etoposide|
16302757|NCT00627354|Drug|mitoxantrone hydrochloride|
16302758|NCT00627354|Drug|prednisone|
16302759|NCT00627354|Drug|vinorelbine tartrate|
16302760|NCT00627341|Behavioral|Food Exposure Therapy and Ritual Prevention with Motivational Enhancement for Relapse Prevention in Anorexia Nervosa (AN-EX/RP)|AN-EX/RP will consist of in-session exposures to feared eating situations without using avoidance behaviors as well as formal motivational interviewing techniques.
16302761|NCT00627341|Behavioral|Cognitive behavioral therapy (CBT)|CBT for anorexia nervosa sessions will focus on behaviorally normalizing eating patterns throughout the day and on cognitively addressing dysfunctional thinking that promotes disordered eating.
16302762|NCT00627315|Procedure|Gastric bypass|NOTE: Surgery will not be paid by the study
16302763|NCT00627315|Procedure|Gastric banding|NOTE: Surgery will not be paid by the study
16302764|NCT00627302|Drug|PEG-400|Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
16302765|NCT00627302|Drug|Systane|Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
16302766|NCT00627276|Dietary Supplement|omega-3 fatty acid|Oral, 3 times daily
16302767|NCT00627276|Other|placebo|Oral, 3 times daily
16302768|NCT00627263|Behavioral|Stress reduction treatment (SRT) program|The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
16302769|NCT00627250|Drug|Amantadine|Amantadine 100 mg every morning and 12 noon
16302770|NCT00627237|Behavioral|Immediate Start|Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
16302771|NCT00627237|Behavioral|Waitlist|Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
16302772|NCT00627211|Procedure|CO2 insufflation|From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.
16302773|NCT00627185|Behavioral|Internet-delivered continuing professional development|Interactive motivational website for dentists and hygienists with practice improvement resources, discussion forum, and educational cases on cessation counseling with email reminders.
16302774|NCT00627185|Other|No intervention arm|
16302775|NCT00627159|Other|High risk assessment|For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All participants predicted to be at high risk are referred for assessment to a High Risk clinic in the community via the family doctor.
16302776|NCT00627159|Other|Low to moderate risk|For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All low to -moderate risk participants are directed to self-refer to the Calgary Health Region Multicultural education classes.
16302777|NCT00627146|Drug|ChAgly CD3|6 days treatment 8mg/d intravenous
16302778|NCT00627146|Drug|Placebo|6 days
16302779|NCT00627133|Drug|levetiracetam|2 gram iv load, 500mg bid
16302780|NCT00627120|Drug|VGX-1027|Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
16302781|NCT00627107|Device|ReWalk - a motorized exoskeleton suit|The subject will wear the ReWalk suit and have training sessions for walking with the device.
16303428|NCT00622934|Drug|erythropoietin|300mg/kg erythropoietin 3 times on the first week of admission
16302783|NCT00627094|Device|Biatain Ibu|Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
16302784|NCT00627081|Drug|remifentanil|dosage
16302785|NCT00627055|Drug|LPV/r|LPV/r dosing = 400mg/100mg orally q12h for 48 weeks
16302786|NCT00627055|Drug|LPV/r + TDF/FTC or TDF/3TC|TDF/FTC (Truvada) 1 pill orally q 24 hr or TDF 300mg orally q 24 hr/3TC 300mg orally q 24 hr (or 3TC 150mg orally q 12 hr) for 48 weeks
16302787|NCT00627042|Biological|Ramucirumab (IMC-1121B)|Participants will receive ramucirumab (IMC-1121B) at 8 milligrams per kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
16302788|NCT00627029|Behavioral|Care Coordination|Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.
16302789|NCT00627016|Drug|Dexlansoprazole|30 mg capsule, orally, once daily for 4 weeks
16302790|NCT00627016|Drug|Placebo|1 capsule, orally, once daily for 4 weeks
16302791|NCT00627003|Drug|Cabergoline|Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks
16302792|NCT00627003|Other|Placebo|Placebo oral tablets administered daily for 5 weeks
16302793|NCT00626990|Drug|temozolomide|Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
16302794|NCT00626990|Genetic|DNA methylation analysis|MGMT methylation status is used for stratification at randomization.
16302795|NCT00626990|Other|laboratory biomarker analysis|Prognostic factor analyses
16302796|NCT00626990|Procedure|adjuvant therapy|Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
16302797|NCT00626990|Procedure|quality-of-life assessment|Quality of Life analysis will also be used to assess neurological deterioration free progression
16302798|NCT00626990|Radiation|radiation therapy|Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
16302799|NCT00626977|Drug|ropivacaine|15 ml of ropivacaine 0.125% peridural once
16302800|NCT00626977|Drug|ropivacaine and clonidine|15 ml of ropivacaine 0.0625% plus 75 mcg clonidine
16302801|NCT00626964|Procedure|Bariatric Surgery|Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
16302802|NCT00626964|Behavioral|Conservative Treatment:|Intensive Lifestyle Intervention Program
16302803|NCT00626951|Device|LMA Supreme|Extraglottic airway devices
16302804|NCT00626951|Device|LMA ProSeal|
16302805|NCT00626925|Drug|topiramate|up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
16302806|NCT00626925|Drug|placebo|placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
16302807|NCT00626912|Procedure|endovascular coil embolization|standard endovascular coil embolization with or without adjunct techniques
16302808|NCT00626886|Drug|Bupivacaine Collagen Sponge|collagen; Bupivacaine hydrocholoride
16302809|NCT00626886|Drug|placebo collagen sponge|collagen
16302810|NCT00626873|Drug|Definity|Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.
16302811|NCT00626873|Other|medical chart review|
16302812|NCT00626860|Biological|DC/tumor fusion vaccine|SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
16302813|NCT00626834|Drug|Vigabatrin|Dose 1 BID
16302814|NCT00626834|Drug|Vigabatrin|Dose 2 BID
16302815|NCT00626834|Drug|Vigabatrin|Dose 3 BID
16302816|NCT00626834|Drug|Matching placebo|Matching placebo BID
16302817|NCT00626821|Device|SenSura|Real life assessment of SenSura
16302818|NCT00626808|Drug|No Intervention|There were no interventions. No subjects were enrolled in this retrospective database study.
16302819|NCT00626795|Drug|TD1414 2% cream|BID 7 days
16302820|NCT00626795|Drug|TD1414 2% cream|TID 7 days
16302821|NCT00626795|Drug|Bactroban® (mupirocin) 2% cream|BID 7 days
16302822|NCT00626782|Drug|Ranibizumab|Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
16302823|NCT00626782|Drug|Mitomycin (MMC)|Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
16302824|NCT00626769|Dietary Supplement|aglycone genistein|2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
16302825|NCT00626769|Dietary Supplement|placebo|2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
16302826|NCT00626756|Device|LiDCO technology|non invasive monitoring of cardiac output
16302827|NCT00626743|Drug|SK3530 100mg, Placebo, Amlodipine|
16302828|NCT00626730|Procedure|adjuvant therapy|
16302829|NCT00626730|Radiation|radiation therapy|
16302830|NCT00626717|Procedure|Riboflavin/UVA crosslinking|Removal of epithelium. Riboflavin eye drops. UVA exposure.
16302831|NCT00626717|Procedure|Sham treatment|Fluorescein eye drops. Exposure with blue light
16302832|NCT00626704|Drug|AMG 655|AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
16302833|NCT00626704|Other|Placebo|Inactive dummy AMG 655 (to maintain blind)
16302834|NCT00626704|Drug|Doxorubicin|Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
16302881|NCT00626366|Drug|Omnipaque 240 Contrast Solution|Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
16303429|NCT00622934|Drug|placebo|placebo
16302835|NCT00626691|Behavioral|Walnut consumption|Subjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged.
16302836|NCT00626678|Drug|Azathioprine|It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
16302837|NCT00626678|Drug|Prednisone|Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.
16302838|NCT00626678|Drug|Placebo|Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
16302839|NCT00626665|Drug|Tadalafil|Tablets Tadalafil, 20 mg, alternate days, 6 weeks
16302840|NCT00626652|Drug|K201 Injection|single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
16302841|NCT00626639|Drug|Placebo|Administered by intravenous (IV) bolus injection
16302842|NCT00626639|Drug|palifermin|Administered by intravenous (IV) bolus injection
16302843|NCT00626639|Radiation|Radiotherapy|Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation [one fraction per day])
16302844|NCT00626639|Drug|Cisplatin|100 mg/m^2 intravenously (IV) on days 1, 22 and 43.
16302845|NCT00626626|Drug|Clofar, Cyclophos, Alemtuzumab|Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
16302846|NCT00626626|Drug|Clofar, Cyclophos,Alemtuzumab(Ph II)|Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
16302847|NCT00626613|Drug|Risperdal,reminyl|Risperdal:The dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg), The maximum dose will be 2ml/ per day reminyl:8 mg/ per day
16302848|NCT00626600|Drug|Oxycodone Hydrochloride|
16302849|NCT00626587|Device|Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)|The TBNA apparatus (Olympus NA-2C-1) is inserted through the working channel, and is advanced until it reaches the target lesion which is localized by EBUS. Negative manual suction is applied with the 20 ml syringe. The specimens are then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion are obtained.
16302850|NCT00626574|Drug|Epoetin alfa|Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
16302851|NCT00626574|Drug|Saline|3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
16302852|NCT00626561|Drug|Bevacizumab|10 mg/kg IV twice weekly on days 1 and 15.
16302853|NCT00626561|Drug|Paclitaxel|60 mg/m^2 IV weekly on days 1, 8, 15, and 22.
16302854|NCT00626548|Drug|ZD4054|10 mg once daily oral dose
16302855|NCT00626548|Drug|Palcebo|Matching Plcebo oral tablet once daily
16302856|NCT00626535|Drug|Esomeprazole|20mg Oral Once Daily
16302857|NCT00626535|Drug|Matching placebo|Oral Once Daily
16302858|NCT00626522|Drug|Aclidinium bromide and formoterol|once daily
16302859|NCT00626522|Drug|Aclidinium bromide and formoterol placebo|once daily
16302860|NCT00626509|Drug|sunitinib malate|
16302861|NCT00626509|Procedure|adjuvant therapy|
16302862|NCT00626509|Procedure|neoadjuvant therapy|
16302863|NCT00626509|Procedure|therapeutic conventional surgery|
16302864|NCT00626483|Biological|RNA-loaded dendritic cell vaccine|Only one dose of DCs (2 x 10^7) is being assessed.
16302865|NCT00626483|Drug|basiliximab|Basiliximab 20 mg and 40 mg is being assessed depending on dose-cohort enrollment.
16302866|NCT00626470|Procedure|Addition of TSP to DHS|All patients operated with DHS. Of these two groups. One operated with TSP and one without.
16302867|NCT00626457|Behavioral|Behavioral weight-loss/lifestyle interventions|6-month intervention (28 weekly classes)
16302868|NCT00626444|Drug|Intravenous vitamin C|Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
16302869|NCT00626431|Drug|Leuprolide acetate - Formulation A|Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.
16302870|NCT00626431|Drug|Leuprolide acetate - Formulation B|Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.
16302871|NCT00626418|Drug|Aplindore|Tablets 0.05, 0.1, 0.2, 0.3, 0.5 and 0.7 mg QD for up to 6 nights
16302872|NCT00626418|Drug|Placebo|Placebo tablets
16302873|NCT00626405|Biological|bevacizumab|Given IV over 30-90 minutes
16302874|NCT00626405|Drug|carboplatin|Given IV over 30 minutes
16302875|NCT00626405|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV over 30 minutes
16302876|NCT00626405|Drug|temozolomide|Oral temozolomide on days 1-5
16302877|NCT00626392|Drug|niacin extended-release (NER)|Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
16302878|NCT00626392|Drug|aspirin (ASA)|325 mg tablets administered once daily
16302879|NCT00626392|Drug|aspirin placebo (ASA Pbo)|Tablets administered once daily
16302880|NCT00626366|Radiation|Sinus CT Scan|Subjects will undergo a Xoran miniCAT scan of their sinuses
16303216|NCT00624429|Drug|Budesonide respules|Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
16302882|NCT00626366|Drug|Omnipaque 240 mg I/mL|Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
16302883|NCT00626353|Other|Home-based rehabilitation|Rehabilitation at home during hospital stay and after discharge
16302884|NCT00626353|Other|Standard care|Standard care during hospital stay and in the municipality after discharge
16302885|NCT00626340|Drug|MDD diagnosis and Estrogen treatment|Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.
16302886|NCT00626340|Drug|MDD diagnosis and Fluoxetine treatment|Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
16302887|NCT00626340|Drug|MDD diagnosis with both Estrogen and Fluoxetine treatment|Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
16302888|NCT00626340|Drug|No depression and estrogen treatment|Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.
16302889|NCT00626327|Biological|MenACWY-CRM + MMRV|One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
16302890|NCT00626327|Biological|MMRV|one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
16302891|NCT00626327|Biological|MenACWY-CRM|Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
16302892|NCT00626314|Biological|myoblast|autologous myoblast
16302893|NCT00626314|Biological|sham|sham injection procedure
16302894|NCT00626301|Drug|LPV/r|LPV/r 230/57.5 mg/m2 orally q12h or the adjusted dose based on therapeutic drug monitoring of LPV/r prior to enrollment as maintenance monotherapy
16302895|NCT00626288|Drug|Mesalazine|Mesalazine 800mg t.i.d. 12 weeks
16302896|NCT00626288|Drug|Placebo|Placebo cpr, t.i.d. 12 weeks
16302897|NCT00626275|Drug|ADL5859|
16302898|NCT00626275|Drug|Naproxen|
16302899|NCT00626275|Drug|Placebo|
16302900|NCT00626275|Drug|ADL5859|
16302901|NCT00626275|Drug|Placebo|
16302902|NCT00626262|Drug|Esomeprazole|Oral and Intravenous
16302903|NCT00626249|Drug|Technosphere Inhalation Powder|Technosphere Inhalation Powder
16302904|NCT00626236|Drug|SPN-810|capsule taken three times a day
16302905|NCT00626236|Drug|SPN-810|capsule taken TID
16302906|NCT00626236|Drug|SPN-810|capsule taken TID
16302907|NCT00626236|Drug|SPN-810|capsule taken TID
16302908|NCT00626223|Drug|5-MTHF (5-methyltetrahydrofolate)|50 mg intravenous at the end of each hemodialysis session
16302909|NCT00626223|Drug|folic acid|5 mg per day of oral folic acid
16302910|NCT00626210|Drug|modafinil|100-400 mg daily for 4 weeks
16302911|NCT00626197|Drug|Corticosteroids|Intravenous and oral repeating dose
16302912|NCT00626197|Drug|Cyclophosphamide|Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.
16302913|NCT00626197|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.
16302914|NCT00626197|Drug|Ocrelizumab|Ocrelizumab was administed at a dose and as per schedule in arm description
16302915|NCT00626197|Drug|Placebo|Placebo was administered as per schedule in arm description
16302916|NCT00626197|Drug|Azathioprine|Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.
16302917|NCT00626184|Drug|4 dose levels of ALV003|4 dose levels of ALV003 vs placebo
16302918|NCT00626171|Procedure|Allergen Challenge|Allergen challenge
16302919|NCT00626158|Drug|gemcitabine|1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)
16302920|NCT00626158|Drug|capecitabine|starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)
16302921|NCT00626145|Procedure|saline infusion|Patients receive intracoronary injections of saline 7 days after PCI.
16302922|NCT00626145|Procedure|autologous bone marrow mononuclear cells infusion|Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
16302923|NCT00626132|Dietary Supplement|Eucommia|two capsules three times a day orally for 2 weeks
16302924|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 2 - placebo with exemestane or fulvestrant
16302925|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant
16302926|NCT00626106|Drug|AMG 479 or placebo administered with either exemestane or fulvestrant|Arm 1 - AMG 479 administered with exemestane or fulvestrant
16302927|NCT00626093|Device|Cardiac Resynchronization Therapy - Defibrillator (CRT-D)|"Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT).
~Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions."
16302928|NCT00626080|Drug|Insulin detemir|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
16302929|NCT00626080|Drug|Insulin NPH|100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID
16302930|NCT00626067|Device|Fully functional monitoring device|Pt received fully functional monitoring dispenser for use with their Travatan eye drops
16302931|NCT00626067|Device|Partially functional monitoring device|Patient received a particually functional Travatan Compliance Monitoring Dispenser
16302932|NCT00626067|Device|Non-functional monitoring device|Patient received a non functioning Travatan Compliance Monitoring Dispenser
16302933|NCT00626054|Drug|PEG solution in a single dose of 3 liters|Group 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
16302934|NCT00626054|Drug|PEG solution|PEG solution: half the dose (1.5 liters) of the identical solution in the evening preceding the test and the other half (1.5 liters) on the morning of the test
16302935|NCT00626041|Other|participant referral to primary care network physician|blood pressure, cholesterol and hemoglobin A1c screening and management
16302936|NCT00626028|Drug|Nitric Oxide for inhalation|Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
16302937|NCT00626028|Drug|Oxygen|100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
16302938|NCT00626028|Drug|Nitric Oxide plus Oxygen|Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
16302939|NCT00626015|Biological|PEP-3-KLH conjugate vaccine|Given intradermally
16302940|NCT00626015|Biological|daclizumab|Given IV
16302941|NCT00626015|Drug|temozolomide|Given by mouth.
16302942|NCT00626015|Other|placebo|Given IV
16302943|NCT00626015|Biological|PEP-3-KLH|Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.
16302944|NCT00626002|Drug|ABT-874|100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks
16302945|NCT00625989|Drug|Aeroallergen|
16302946|NCT00625976|Behavioral|Graded exposure in vivo|Graded exposure in vivo according to the protocol of de Jong et al. (2005)
16302947|NCT00625976|Behavioral|Physiotherapy|Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
16302948|NCT00625950|Procedure|ENDOMETRIAL BIOPSY|Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.
16302949|NCT00625937|Drug|cisplatin|
16302950|NCT00625937|Drug|docetaxel|
16302951|NCT00625937|Drug|tegafur-gimeracil-oteracil potassium|
16302952|NCT00625937|Radiation|radiation therapy|
16302953|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States - Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
16302954|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States -Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
16302955|NCT00625924|Behavioral|questionnaires|Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States -Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'
16302956|NCT00625911|Drug|morphine|intravenous patient controlled analgesia, standard protocol
16302957|NCT00625911|Drug|morphine ketamine|low dose ketamine added to 2/3 standard dose of morphine
16302958|NCT00625898|Drug|Docetaxel|"75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B
~100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B"
16302959|NCT00625898|Drug|Trastuzumab|"First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B
~First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B"
16302960|NCT00625898|Drug|Carboplatin|6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6
16302961|NCT00625898|Drug|Bevacizumab|"15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B
~15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B"
16302962|NCT00625898|Drug|5-Fluorouracil|600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
16302963|NCT00625898|Drug|Epirubicin|90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
16302964|NCT00625898|Drug|Cyclophosphamide|600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
16302965|NCT00625872|Drug|Somatropin|Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
16302966|NCT00625872|Drug|Somatropin|Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
16302967|NCT00625859|Drug|GSK189075|GSK189075 will be available as film-coated tablets with a dose of 250 milligrams.
16302968|NCT00625859|Drug|Bupropion|Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally.
16302969|NCT00625859|Drug|Placebo|Placebo tablets will be given to subjects.
16302970|NCT00625846|Other|Laboratory Biomarker Analysis|Correlative studies
16302971|NCT00625846|Drug|Pazopanib Hydrochloride|Given PO
16302972|NCT00625833|Drug|Placebo|Oral tablet once a day dosing for 10 weeks.
16302973|NCT00625833|Drug|[S,S]-Reboxetine|Oral tablet once a day dosing for 10 weeks.
16302974|NCT00625820|Drug|6R BH4|400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks in all arms
16302975|NCT00625820|Dietary Supplement|Vitamin C|500 mg Vitamin C oral BID for another 6 weeks
16302976|NCT00625807|Behavioral|RR|A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
16302977|NCT00625807|Behavioral|MBSR|A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
16302978|NCT00625794|Drug|Nicotine nasal spray|8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).
16302979|NCT00625794|Behavioral|Smoking cessation counseling|8 weeks or counseling
16302980|NCT00625781|Drug|Insulin aspart and Insulin human (isophane)|Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.
16302981|NCT00625768|Drug|AS1409|Study drug
16302982|NCT00625755|Biological|Electrofusion DC vaccine|To assess the safety and efficacy of vaccinations
16302983|NCT00625742|Behavioral|Graded Resistance Training|Resistance training sessions twice weekly using Thera-bands.
16302984|NCT00625742|Behavioral|Aerobic Exercise|Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.
16302985|NCT00625742|Drug|Melatonin|20 mg by mouth (PO) Daily
16302986|NCT00625742|Dietary Supplement|Juven|90 calories of Juven, twice a day.
16302987|NCT00625742|Drug|Atenolol|Atenolol will only be taken if there's evidence of increased sympathetic activity (resting heart rate >110 beats/min) or resting energy expenditure (REE) > 110% of predicted.
16302988|NCT00625742|Drug|Ibuprofen|Ibuprofen 1200mg/day in three divided doses.
16302989|NCT00625729|Biological|aldesleukin|Day 0-14, 10 million international units, 3 times per week for 6 doses
16302990|NCT00625729|Biological|allogeneic natural killer cells|Day 0 infusion of cells (1.5-8 x 10^7 cells/kg).
16302991|NCT00625729|Biological|rituximab|Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m^2
16302992|NCT00625729|Drug|cyclophosphamide|60 mg/kg intravenous (IV) on Day -5.
16302993|NCT00625729|Drug|fludarabine phosphate|Day -6 through day -2, 25 mg/m^2 intravenous (IV)
16302994|NCT00625703|Drug|Linezolid|"Pharmacokinetics
~daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."
16302995|NCT00625690|Other|questionnaire administration|Subjects will be asked to complete an additional detailed questionnaire regarding personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members.
16302996|NCT00625690|Procedure|computed tomography|The baseline and repeat screening CT scans will be performed with a multi-slice helical CT scanner (8 or more rows), at a low-dose setting (120kVp, 40-80mA, slice thickness of 1.25 mm or less). In a single breath-hold, contiguous slices from the thoracic inlet to the adrenal glands will be obtained. Contrast material will not be used. Multi-slice scanners will be used because they provide higher-resolution images. Diagnostic studies, including HRCT will be performed with a multi-slice helical CT at diagnostic settings (120kVp, 140-300mA, slice thickness of 1.25 or less) with the nodule retrospectively reconstructed at a 15cm field of view.
16302997|NCT00625690|Procedure|evaluation of cancer risk factors|When the CT scan at baseline does not lead to the diagnosis of malignancy, repeat screening will be scheduled 12 months later. If the initial scan led to further evaluation, the repeat scan will be performed 12 months after the most recent scan. The subjects will be allowed to add relevant health information to their record in the web-based database as it develops. Similarly, when in the first repeat screening malignancy is not diagnosed; the second repeat screening will be scheduled 12 months later for a total period of 5 years.
16302998|NCT00625690|Procedure|study of high risk factors|When the CT scan at baseline does not lead to the diagnosis of malignancy, repeat screening will be scheduled 12 months later. If the initial scan led to further evaluation, the repeat scan will be performed 12 months after the most recent scan. The subjects will be allowed to add relevant health information to their record in the web-based database as it develops. Similarly, when in the first repeat screening malignancy is not diagnosed; the second repeat screening will be scheduled 12 months later for a total period of 5 years.
16302999|NCT00625677|Biological|NeisVacC (Meningococcal C conjugate vaccine)|Dosage
16303000|NCT00625677|Biological|Menjugate (Meningococcal C conjugate vaccine)|Dosage
16303001|NCT00625664|Drug|larotaxel (XRP9881)|administered on day 1 as a 1-hour infusion
16303002|NCT00625664|Drug|gemcitabine|administered on day 1, 8 and 15 as a 30-minute infusion
16303003|NCT00625664|Drug|cisplatin|1 hour infusion administered on day 1, 30 minutes after the other treatment
16303004|NCT00625651|Drug|Placebo|Inactive dummy AMG 655 (to maintain blind)
16303005|NCT00625651|Drug|AMG 655|AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
16303006|NCT00625651|Drug|Modified FOLFOX6|Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
16303007|NCT00625651|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
16303008|NCT00625638|Behavioral|Interactive Voice Response System|Phone calls made once daily, each taking about 3-5 minutes to complete.
16303009|NCT00625638|Other|Standard Care|Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.
16303010|NCT00625625|Drug|isosulfan blue|
16303011|NCT00625625|Genetic|polymerase chain reaction|
16303012|NCT00625625|Other|diagnostic laboratory biomarker analysis|
16303013|NCT00625625|Other|immunohistochemistry staining method|
16303014|NCT00625625|Procedure|diagnostic lymphadenectomy|
16303015|NCT00625625|Procedure|therapeutic conventional surgery|
16303016|NCT00625625|Procedure|therapeutic lymphadenectomy|
16303017|NCT00625612|Drug|Denufosol Tetrasodium (INS37217) Inhalation Solution|Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
16303018|NCT00625612|Drug|Placebo|Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
16303019|NCT00625599|Other|Osteoporosis Prevention Information|Primary investigator designed osteoporosis prevention information.
16303217|NCT00624416|Drug|Prednisolone synthetic cortisone and Isoproterenol together|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
16303020|NCT00625586|Biological|RAV12 plus gemcitabine|"Initial dose of gemcitabine plus RAV12 at 0.375 mg/kg qw escalated to 0.75 mg/kg qw.
~During the efficacy segment, 63 pts were to be treated with gemcitabine 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days plus RAV12 at Maximum Tolerated Dose (MTD) iv days 1; 4 or 5; 8, 11 or 12; and 15, 18 or 19 of each 28-day cycle until progression."
16303021|NCT00625573|Drug|Abraxane|100mg/m2 every week X's 3
16303022|NCT00625560|Drug|Entecavir|entecavir 1.0 mg QD
16303023|NCT00625560|Drug|Lamivudine|lamivudine 100 mg QD
16303024|NCT00625547|Drug|cabergoline|Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
16303025|NCT00625547|Drug|levodopa|Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
16303026|NCT00625534|Procedure|Laparoscopic totally extraperitoneal inguinal hernia repair|3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.
16303027|NCT00625534|Procedure|Open tension free inguinal hernia mesh repair|Classical Lichtenstein repair. Polyester flat 14x8cm mesh
16303028|NCT00625521|Drug|ASF 1096 0.5 % cream applied twice daily|
16303029|NCT00625521|Drug|Cream vehicle for ASF 1096 cream applied twice daily|
16303030|NCT00625495|Drug|Esomeprazole|40mg Intravenous infusion over 3 minutes
16303031|NCT00625495|Drug|Esomeprazole|40mg Oral
16303032|NCT00625482|Biological|OPV|
16303033|NCT00625482|Biological|OPV plus BCG|
16303034|NCT00625482|Biological|OPV|
16303035|NCT00625482|Biological|OPV plus BCG|
16303036|NCT00625469|Drug|bosentan|62.5mg orally bid for first month, followed by 125mg bid thereafter
16303037|NCT00625456|Drug|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)|Intravenous Dosage from 1 x 10^5 pfu/kg to 3 x 10^7 pfu/kg Intravenous infusion is administered once over a 60 minute period
16303038|NCT00625443|Drug|Blinded (placebo)|"Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
16303039|NCT00625443|Drug|Open Label (Avatrombopag tablets)|"Dose 10 mg
~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
16303040|NCT00625443|Drug|Blinded (Avatrombopoag tablets)|"Dose: 2.5, 5, 10, or 20 mg
~Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
~Duration - 6 months"
16303041|NCT00625430|Biological|Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine|"Subjects within a treatment group will be administered a single transrectal intraprostatic injection of FP253.
~Group A: 1 x 10Exp9 virus particles (VP); Group B: 3.2 x 10Exp9 VP; Group C: 1 x 10Exp10 VP; Group D: 3.2 x 10Exp10 VP; Group E: 1 x 10Exp11 VP; Group F: 3.2 x 10Exp 11 VP.
~If there are no dose-limiting toxicities, three additional patients may be treated at the highest dose.
~Twenty four hours following administration of the FP253, subjects will receive a first dose of fludarabine phosphate (20mg/m2 administered as an intravenous bolus). The first dose of fludarabine phosphate will be followed by 4 further doses at 24 hour intervals on treatment Days 3 to 6."
16303042|NCT00625417|Procedure|breast biopsy|
16303043|NCT00625417|Procedure|histopathologic examination|
16303044|NCT00625417|Procedure|light-scattering spectroscopy|
16303045|NCT00625417|Procedure|therapeutic conventional surgery|
16303046|NCT00625404|Drug|Truvada|Daily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
16303047|NCT00625404|Other|Placebo|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
16303048|NCT00625391|Drug|Placebo|500 mg medicinal starch pills daily
16303049|NCT00625391|Drug|Green Tea Polyphenols (GTP)|500 mg green tea polyphenols daily
16303050|NCT00625391|Drug|Placebo+Tai Chi (TC)|500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
16303051|NCT00625391|Drug|GTP+TC|500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
16303053|NCT00625365|Drug|DEFINITY®|DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert
16303054|NCT00625352|Drug|Gemcitabine, UFT|Gemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression.
16303055|NCT00625339|Drug|Entecavir|entecavir 0.5 mg QD
16303056|NCT00625339|Drug|Lamivudine|lamivudine 100 mg QD
16303057|NCT00625326|Drug|COL-121|75 µg/g COL-121 Ointment
16303058|NCT00625326|Drug|50 µg/g Calcipotriene Ointment|50 µg/g Calcipotriene Ointment
16303059|NCT00625326|Drug|Placebo|Placebo
16303060|NCT00625326|Drug|COL-121|150 µg/g COL-121 Ointment
16303061|NCT00625326|Drug|COL-121|300 µg/g COL-121 Ointment
16303062|NCT00625313|Device|HMY Model YA-60BB IOL|Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
16303063|NCT00625300|Device|repetitive transcranial stimulation (r-TMS)|Each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex.
16303064|NCT00625300|Device|Repetitive transcranial stimulation|Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of sham stimulation trains over the motor cortex and the prefrontal cortex.
16303065|NCT00625274|Drug|Esomeprazole|40mg Oral
16303066|NCT00625274|Drug|Lansoprazole|30mg Oral
16303067|NCT00625274|Drug|Pantoprazole|40mg Oral
16303068|NCT00625261|Other|Heidelberg Parent-based Language Intervention HPLI|The HPLI is a group program for parents of young children with language delay. This 12-14week program includes seven two-our sessions and one three-our session six months later. It is designed for 5 to 10 people and based of an interactive model of language intervention, wich presumes that optimized parental input will provide better language-learning opportunities.
16303069|NCT00625248|Drug|Antithrombotics|With or without or discontinuted use of Antithrombotics
16303070|NCT00625235|Dietary Supplement|VLED followed by a high protein or high carbohydrate diet|
16303071|NCT00625222|Procedure|transcranial direct current stimulation|1mA, 15 Minutes, constant direct current
16303072|NCT00625209|Drug|placebos|placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of fludrocortisone given through the nasogastric tube once a day for seven days plus placebo of activated protein C given as a continuous infusion for 96 hours
16303073|NCT00625209|Drug|hydrocortisone and fludrocortisone and placebo|hydrocortisone will be given as 50mg iv bolus every 6 hours for seven days and a tablet of 50µg of fludrocortisone will be given once a day via the nasogastric tube for seven days and a placebo of activated protein C will be given as a continuous infusion for 96 hours
16303074|NCT00625209|Drug|recombinant human activated protein C and placebos|activated protein C will be given as a continuous infusion at a dose of 24 µg/kg/h four 96 hours and hydrocortisone placebo as an iv bolus every 6 hours and fludrocortisone placebo once a day through the gastric tube will be given for seven days
16303075|NCT00625209|Drug|recombinant human activated protein C and hydrocortisone and fludrocortisone|96 hours continuous infusion of 24µg/kg/h of activated protein C plus seven day treatment with 50mg iv bolus of hydrocortisone every 6 hours and 50µg of fludrocortisone via the nasogastric tube once a day
16303076|NCT00625196|Drug|Fluticasone foroate/ vilanterol|Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.
16303077|NCT00625196|Drug|Fluticasone foroate|Fluticasone foroate 800 micrograms will be available as dry powder inhaler.
16303078|NCT00625196|Drug|Vilanterol|Vilanterol will be available as dry powder inhaler.
16303079|NCT00625196|Drug|Placebo|Placebo will be supplied as dry powder inhaler.
16303080|NCT00625183|Dietary Supplement|selenomethionine|
16303081|NCT00625183|Drug|capecitabine|
16303082|NCT00625183|Drug|oxaliplatin|
16303083|NCT00625183|Other|laboratory biomarker analysis|
16303084|NCT00625183|Other|pharmacological study|
16303085|NCT00625183|Procedure|adjuvant therapy|
16303086|NCT00625183|Procedure|neoadjuvant therapy|
16303087|NCT00625183|Procedure|therapeutic conventional surgery|
16303088|NCT00625183|Radiation|radiation therapy|
16303089|NCT00625170|Drug|olanzapine|olanzapine 10 mg/day for 8 days
16303090|NCT00625170|Drug|Haloperidol|haloperidol 3 mg/day for 8 days
16303091|NCT00625157|Drug|ASF 1096 0.5 % cream|
16303092|NCT00625157|Drug|ASF 1096 placebo cream|
16303093|NCT00625131|Drug|Nicotine|Delivered through transdermal nicotine patch
16303094|NCT00625131|Behavioral|Cognitive Behavioral Therapy for Smoking Cessation|Manualized protocol for CBT in smoking cessation
16303095|NCT00625131|Drug|Bupropion Sustained Release (SR)|Antidepressant
16303096|NCT00625131|Drug|Placebo patch|Pre-treatment placebo transdermal patch
16303097|NCT00625105|Behavioral|Biofeedback|
16303098|NCT00625092|Drug|fluorouracil|Post-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours
16303099|NCT00625092|Drug|leucovorin calcium|Day 0 200 mg/m^2 intraperitoneal held for 2 hours
16303100|NCT00625092|Drug|oxaliplatin|Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2
16303101|NCT00625092|Procedure|cytoreductive surgery|Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.
16303102|NCT00625079|Drug|sildenafil|the dose of sildenafil will be 20mg three times per day (orally)
16303103|NCT00625066|Other|biologic sample preservation procedure|
16303104|NCT00625066|Other|cytology specimen collection procedure|
16303105|NCT00625066|Other|medical chart review|
16303106|NCT00625066|Other|questionnaire administration|
16303107|NCT00625066|Other|survey administration|
16303108|NCT00625066|Procedure|biopsy|
16303109|NCT00625066|Procedure|evaluation of cancer risk factors|
16303110|NCT00625066|Procedure|screening colonoscopy|
16303111|NCT00625053|Procedure|Laparoscopic repair|Complete adhesiolysis between viscera and abdominal wall, complete dissection of round ligament and subumbilical fatty tissue to expose the posterior fascia at least 5 cm further than the cranial and caudal limits of the fascial defect or the original incision. Overlap of minimum 5 cm is calculated and mesh inserted in the abdominal cavity through 12mm optical trocar. Fixation of a antiadhesive composite mesh with helicoidal pins with maximum 15mm interval, double crown technique. No pressure decrease maneuver is done during mesh fixation or at another time during the operation. No transparietal suture fixation. No fascial closure.
16303112|NCT00625053|Procedure|Open midline incisional hernia repair|"Underlay retromuscular repair: Medial border of the anterior fascia opened, posterior aspect of rectus muscle dissected to reach lateral border of rectus sheet, bilaterally. Peritoneum and posterior rectus fascia closed with absorbable running suture. Polyester or light-weight polypropylene mesh is cut to fit the reconstructed area, to have 3cm overlap on caudal and cranial defect limits. Mesh is fixed by absorbable sutures. Anterior fascia is closed with absorbable running suture. Components separation upon need.
~Intraperitoneal onlay repair: Mesh is inserted intraperitoneally and fixed by a complete running suture (optional fixation with helicoidal pins or stapler). Fascial defect is closed with interrupted or running absorbable suture. Components separation upon need."
16303113|NCT00625040|Other|Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate|"OGTT: The test is performed with 50 g of glucose deluded in 300 ml water
~Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT
~Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water
~Gastric Emptying Rate: Paracetamol absorption test."
16303218|NCT00624403|Device|Laryngeal mask insertion (LMA ProSeal)|Laryngeal mask insertion
16303219|NCT00624403|Device|Laryngeal mask insertion (I-Gel)|Laryngeal mask insertion
16303114|NCT00625027|Other|Survey and Chart Review|After obtaining consent the survey will be completed. After a staff physician has assessed the patient, the chart will be consulted to retrieve the triage notes, diagnosis, treatment, and discharge recommendations. The physician will be asked to comment on the 'urgency' of the complaint and whether the patient would have been treated equally well at a walk-in clinic.
16303115|NCT00625014|Drug|Haloperidol|Haloperidol 3 mg/day for 8 days
16303116|NCT00624988|Procedure|Vibration Therapy|Treatment will consist of 10 sessions of 60 seconds each with one minute intervals in between at 50 Hz frequency three times per week for three months.
16303117|NCT00624975|Biological|Peru-15 Vaccine|up to 1 x 10^9 CFU of Peru-15 given in 5ml single dose vials with 20 ml buffer solution, given once
16303118|NCT00624975|Biological|Placebo|25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water)
16303119|NCT00624962|Dietary Supplement|nutritional intervention|Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)
16303120|NCT00624962|Dietary Supplement|therapeutic nutritional supplementation|enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
16303121|NCT00624936|Drug|Vidaza|Vidaza 75mg/m2 IV over 30min daily on days 1-7. This dose is the same for all dose levels.
16303122|NCT00624936|Drug|Velcade|Dose level 1 Velcade 0.7mg/m2 IVP on days 2 and 5 Dose level 2 Velcade 0.7mg/m2 IVP on days 2, 5, 9, 12 Dose level 3 Velcade 1.0 mg/m2 IVP on days 2, 5, 9, 12 Dose level 4 Velcade 1.3 mg/m2 IVP on days 2, 5, 9, 12
16303123|NCT00624923|Drug|Salsalate|Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
16303124|NCT00624923|Drug|Placebo|Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months
16303125|NCT00624910|Drug|Bupivacaine Collagen Sponge (CollaRx®)|The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
16303126|NCT00624910|Drug|placebo|The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
16303127|NCT00624871|Drug|Ascorbic acid (vitamin C)|IV, 100 mg/kg/day, every day, for 3 days
16303128|NCT00624871|Drug|Ibuprofen|PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
16303129|NCT00624871|Drug|Placebo|
16303130|NCT00624858|Drug|naltrexone SR 32 mg/ bupropion SR 360 mg daily|"All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
~During the study, subjects will receive ancillary therapy including advice on diet and exercise"
16303131|NCT00624845|Drug|OMS103HP|Maximum 6 bags of OMS103HP irrigation solution
16303132|NCT00624845|Drug|Vehicle|Maximum of 6 bags of vehicle irrigation solution
16303133|NCT00624832|Drug|Xolair|Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
16303134|NCT00624832|Drug|Placebo|Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
16303135|NCT00624819|Biological|GSK1024805A|No vaccination in this trial
16303136|NCT00624819|Biological|Prevenar|No vaccination in this trial
16303137|NCT00624819|Biological|Infanrix hexa|No vaccination in this trial
16303138|NCT00624819|Biological|Havrix|No vaccination in this trial
16303139|NCT00624819|Biological|Varilrix|No vaccination in this trial
16303140|NCT00624806|Behavioral|Daily telephone calls|Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
16303141|NCT00624806|Behavioral|Weekly telephone calls|Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
16303142|NCT00624793|Other|Acupuncture|Standard Acup point protocol for treating nausea
16303143|NCT00624793|Other|Individualized Acup based on TCM diagnosis|Acup
16303144|NCT00624793|Other|Sham Acup|Sham Acup - Non-Active
16303145|NCT00624780|Drug|Pregabalin|Pregabalin 150-300 mg given twice a day
16303146|NCT00624780|Drug|Lorazepam|Lorazepam 3-4 mg given twice a day
16303147|NCT00624780|Drug|Pregabalin|Pregabalin 450-600 mg given twice a day
16303148|NCT00624780|Drug|Placebo|Placebo
16303149|NCT00624767|Drug|Insulin (recombinant human insulin)|Insulin Nasal Spray at doses up to 200 IU.
16303150|NCT00624767|Drug|NovoLog|NovoLog at doses up to 30 IU
16303151|NCT00624754|Drug|Formoterol/Budesonide|Budesonide/Formoterol 400/12: 800 µg b.i.d for 1 month
16303152|NCT00624754|Drug|lactose|Lactose 2 puffs b.i.d for 1 month
16303153|NCT00624741|Drug|Pergolide|Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.
16303154|NCT00624728|Radiation|18F Fluorothymidine PET CT|"18 FLT will be provided by the Laboratoire des Radiopharmaceutiques- Université Bordeaux2, Hôpital Xavier Arnozan and prepared according to the method described by Grierson and Shields ( Grierson J, Shields A. Nucl Med Biol 27 :143-156 ; 2000).
~Specific activity of 18FLT will be more than 37 GBq/µmol (>1Ci/µmol) corrected for decay at the end of bombardment of cyclotron target. Before tracer injection to patients, each dosis will be tested for pH and for radiochemical purity (> 95%) via HPLC technique and thin layer chromatography.
~18FLT dosis will be injected intravenously to the patients (10 mL of salted isotonic solution with less than 10 % (v/v) of ethanol (USP). Administrated activity will be calculated estimating total body surface of patient (2,6 MBq/kg ou 0,07 mCi/kg) with maximal activity of 185 MBq.
~PET acquisition will be realized as follows : Dynamic acquisition in 3D mode for 35 min, Iterative reconstruction (OSEM) with and without attenuation correction."
16303220|NCT00624390|Device|Sepraspray|
16303221|NCT00624377|Drug|Tiotropium|Tiotropium 18 mcg HandiHaler once daily
16303222|NCT00624364|Drug|biphasic insulin aspart|
16303155|NCT00624715|Drug|THC|"High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking a full joint
~Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint
~Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking 1/10 of a joint"
16303156|NCT00624715|Drug|Placebo|Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).
16303157|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
16303158|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
16303159|NCT00624702|Drug|Indacaterol maleate|Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
16303160|NCT00624702|Drug|Placebo|
16303161|NCT00624689|Dietary Supplement|Modified formula (MFGM-enriched formula with reduced energy and protein content)|MFGM-enriched formula with reduced energy and protein content
16303162|NCT00624676|Drug|Lipo Hydroxy Acid|Twice a day
16303163|NCT00624676|Drug|5% benzoyl peroxide gel|Once a day
16303164|NCT00624663|Drug|Rivastigmine|Administration 1 (A): 1 x 1.5 mg Exelon® Capsule (Novartis) + 1 x Placebo Capsule Administration 2 (B): 2 x 1.5 mg Exelon® Capsules (Novartis) Administration 3 (C): 2 x Placebo Capsules
16303165|NCT00624650|Drug|Diuresis (furosemide) part I|"Goal: Overall I/O net negative 50ml/hour
~Initiation:
~Continuous IV furosemide at 3mg/hour or last known protocol specified dose
~Titrate up or down by 3mg/hour increments every hour as needed to establish diuresis goal
~Do not exceed 30mg/hour
~Furosemide Bolus:
~If unable to establish adequate diuresis at maximum dose may attempt furosemide bolusing as follows
~By intravenous bolus give 30, then 60, then 80, and 120 mg - one bolus dose every hour until urine output results in 1 ml/kg PBW/hr net negative fluid balance per hour
~Bolusing trials may be done at will but total furosemide dose may not exceed 800mg/24hour period"
16303166|NCT00624650|Other|Fluid Bolus (crystalloid or albumin)|15 ml/kg PBW crystalloid (round to nearest 250 ml) or 25 grams albumin as rapidly as possible. Used for patients with a measured CVP<8 or measured PaOP <12mmHg in addition to concurrent urine output of <0.5 ml/kg/hr
16303167|NCT00624650|Other|Fluid Bolus (crystalloid or albumin)|"10 ml/kg PBW crystalloid (round to nearest 70ml) or 25 grams albumin as rapidly as possible.
~Perform thermodilution immediately before and after and 60 minutes after each bolus. If EVLW increases > 2ml/kg PBW within 60 minutes after a bolus do not give any further boluses until next regularly scheduled measurement. This therapy is available for patients with a map < 60 or who are on vasopressors that also have a measured GEDI less than goal"
16303168|NCT00624650|Drug|Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)|"(may use any alone or in combination)
~Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
~Vasopressin - 0.04 international units/hour
~Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
~Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.
~Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg."
16303169|NCT00624650|Drug|Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)|"(may use alone or in combination)
~Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
~Vasopressin - 0.04 international units/hour
~Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
~Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.
~Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg.
~In the experimental arm vasopressors are a treatment option in patients with a Mean Arterial Pressure of < 60"
16303170|NCT00624650|Drug|Dobutamine|"Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
~Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
~If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol.
~Used in patients with a measured cardiac index < 2.5"
16303171|NCT00624650|Drug|Dobutamine|"Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
~Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
~If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol."
16303172|NCT00624650|Other|Concentrate all drips and nutrition|"Concentrate all drips and nutrition in order to minimize fluid volume as much as possible. Intravenous fluid to be run at keep vein open rate.
~EVLW arm: Patients with a MAP > 60 and off vasopressors for >12 hours, as well as patients with a measured cardiac index >2.5 that also have a measured GEDI > goal."
16303173|NCT00624650|Drug|Diuresis (furosemide) part II|"Withhold furosemide if:
~Significant hypokalemia (K+ <= 2.5 meq/L), or hypernatremia (Na+ >= 155 meq/L) occurs within last 12 hours may then be restarted if the prevailing condition no longer exists
~Dialysis dependence
~Oliguria (less than 0.5ml/kg/hour) with either creatinine > 3, or clinical suspicion of rapidly evolving ARF
~More than 800mg has been given in less then 24 hours
~Creatinine increases > 1.5 mg/dl in any 24 hour period"
16303174|NCT00624650|Procedure|Dialysis|"Need for CVVHD or intermittent hemodialysis to be determined by treating clinicians.
~CVC arm: If fluid management to be accomplished with dialysis then fluid balance goals to be determined per clinicians.
~EVLW arm: Fluid balance as per algorithm
~When using intermittent HD it is recommended that no more than 2 liters net negative fluid is removed per dialysis session. Total fluid removal per run to be estimated by the clinicians to attain CVP or GEDI goals per algorithm."
16303175|NCT00624637|Other|aromatherapy massage|Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
16303223|NCT00624364|Drug|metformin|
16303224|NCT00624351|Biological|Epratuzumab|Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
16303225|NCT00624351|Other|Placebo|Phosphate-buffered Saline (PBS) infusion.
16303176|NCT00624611|Procedure|Residual pump blood management post aortic cannula removal|Residual pump blood will be maximally hemoconcentrated by further ultrafiltation within the CPB machine. Resulting hematocrit will be approximately 0.4. The total residual pump blood volume, approximately 300ml, will be reinfused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Additional protamine sulfate will be given every 30 minutes during the infusion, .03 mg/ml of residual pump blood. Procedures in this group do not deviate from current standard practice.
16303177|NCT00624611|Procedure|Residual pump blood management post aortic cannula removal|All residual pump blood will be processed with a bedside red cell washing device (Cell Saver). The resulting total volume of concentrated red cells will be infused over one hour, beginning 15 minutes after removal of the aortic cross clamp. Administration of additional protamine is not required due to the low concentrations of heparin in the resulting product.
16303178|NCT00624598|Behavioral|SMART|Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
16303179|NCT00624585|Drug|Dasatinib|"DOSE ESCALATION OF DASATINIB AFTER 8 WEEKS IF ELIGIBLE
~Dose Level and Dose of dasatinib:
~Starting dose (1-8 weeks)= 100 mg orally (po) daily
~+1 (<8 weeks if no PR and well tolerated) = 150 mg po daily
~DOSE MODIFICATION OF DASATINIB
~Dose Level and Dose of dasatinib:
~Starting dose = 100 mg po daily
~-1 = 70 mg po daily
~-2 = 50 mg po daily
~OR
~Dose Level and Dose of dasatinib:
~Starting dose = 150 mg po daily
~-1 = 120 mg po daily
~-2 = 90 mg po daily
~-3 = 50 mg po daily"
16303180|NCT00624572|Drug|chlorexidine|Chlorexidine gel 1% during 7 days inside root canals
16303181|NCT00624559|Drug|celecoxib (Celebrex)|Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet
16303182|NCT00624559|Other|Placebo|Placebo pill taken twice per day on each day of the diet
16303183|NCT00624546|Drug|Prevacid Solutabs|BID Prevacid Solutabs
16303184|NCT00624546|Procedure|Antireflux surgery|Lap Nissen
16303185|NCT00624533|Behavioral|GDS Method (muscular chains physical therapy method)|Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.
16303186|NCT00624533|Behavioral|Conventional Physical Therapy in Primary Health Care|"Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.
~Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks."
16303187|NCT00624520|Behavioral|Cognitive Behavioral Stress Management (CBSM)|10 week program of weekly CBSM therapy group sessions
16303188|NCT00624520|Other|Patient Education|"10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
16303189|NCT00624494|Device|Conventional monitoring|In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
16303190|NCT00624494|Device|Advanced monitoring|In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.
16303191|NCT00624481|Drug|Teriparatide|20ug subcutaneous injection daily for 24 weeks
16303192|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
16303193|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
16303194|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
16303195|NCT00624481|Drug|Teriparatide Nasal Spray|teriparatide intranasally daily for 24 weeks
16303196|NCT00624468|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
16303197|NCT00624468|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
16303198|NCT00624455|Drug|Gabapentin|One dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg.
16303199|NCT00624455|Drug|Placebo|Placebo
16303200|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h
16303201|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h
16303202|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
16303203|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h
16303204|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h
16303205|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h
16303206|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h
16303207|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h
16303208|NCT00624442|Drug|Placebo|IV infusion for 2 hours
16303209|NCT00624442|Drug|Placebo|IV infusion for 24 hours
16303210|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
16303211|NCT00624442|Drug|Placebo|IV infusion for 72 hours
16303212|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
16303213|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h
16303214|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h
16303215|NCT00624442|Drug|CK-1827452|IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h
16303511|NCT00622375|Drug|mesalamine|encapsulated mesalamine granules
16303226|NCT00624338|Drug|Atacicept 75 mg|75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
16303227|NCT00624338|Drug|Atacicept 150 mg|150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
16303228|NCT00624338|Other|Placebo Comparator|Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
16303229|NCT00624325|Drug|interferon alfa-2b|12 MU daily continuously subcutaneous
16303230|NCT00624325|Drug|interferon alfa-2b|9 MU daily continuously subcutaneous
16303231|NCT00624325|Drug|interferon alfa-2b|6 MU daily continuously subcutaneous
16303232|NCT00624312|Drug|Procrit|"10 days prior to surgery - injection of 60,000 IU of Procrit
~Day of surgery - injection of 60,000 IU of Procrit"
16303233|NCT00624312|Drug|Placebo|"10 days prior to surgery - injection with 60,000 IU of placebo
~Day of surgery - injection with 60,000 IU of placebo"
16303234|NCT00624299|Drug|Botox|Botox injection (100 ius) per muscle
16303235|NCT00624299|Other|Saline|Saline injection
16303236|NCT00624286|Drug|Indacaterol 150 μg|Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16303237|NCT00624286|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16303238|NCT00624273|Drug|Sildenafil therapy|oral use
16303239|NCT00624260|Other|semi-annual systematic PET-TDM|semi-annual systematic PET-TDM
16303240|NCT00624260|Other|PET-TDM for current indication|PET-TDM for current indication (high isolated markers or before a metastasis curative resection)
16303241|NCT00624247|Other|routine HIV testing|Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
16303242|NCT00624234|Behavioral|Tutoring Program I|Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
16303243|NCT00624234|Behavioral|Tutoring Program II|Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
16303244|NCT00624221|Procedure|Descemet's stripping endothelial keratoplasty|Small incision corneal transplant procedure to treat dysfunctional endothelium.
16303245|NCT00624208|Drug|droperidol and saline|droperidol 20 mcg.kg-1 and saline
16303246|NCT00624208|Drug|ondansetron and saline|ondansetron 0.1 mg.kg-1 and saline
16303247|NCT00624208|Drug|droperidol and ondansetron|droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1
16303248|NCT00624208|Drug|saline and saline|saline and saline
16303249|NCT00624195|Drug|FDA Approved Antiretroviral Therapy (see list below)|"Combinations of FDA approved antiretroviral agents:
~Atripla, Combivir, Emtriva, Epivir, Epzicom, Retrovir, Trizivir, Truvada, Viread, Ziagen, Intelence, Rescriptor, Sustiva, Viramune, Agenerase, Aptivus, Invirase, Kaletra, Lexiva, Norvir, Prezista, Reyataz, Viracept, Fuzeon, Selzentry, Isentress
~Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
16303250|NCT00624182|Biological|Peptide vaccine for URLC10|Increasing the doses of URLC10 peptides will be administered by subcutaneous injection on day 1, 8, 15, and 22 of each 28-day treatment cycles. Doses of 0.5, 1.0, 2.0mg/body are planned. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
16303251|NCT00624182|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, and 15. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
16303252|NCT00624169|Procedure|An optimized perioperative course|A number of interventions before, during and after surgery
16303253|NCT00624156|Behavioral|Writing Intervention|Participants in the emotional disclosure condition will be instructed to write continuously for 20 minutes about their deepest thoughts and feelings regarding their cancer experience.
16303254|NCT00624156|Behavioral|Writing Intervention|Participants assigned to the control condition will be instructed to describe in a detailed, nonemotional manner their daily activities. The 20-minute writing task will be introduced as a time management intervention
16303255|NCT00624143|Drug|ORAL VORICONAZOLE and IV Amphotericin B|Oral Voriconazole will be given in dose of 6mg/kg 12 hourly on day1 then 4mg/kg 12 hourly daily or IV Amphotericin B 0.5 mg/kg/day weekly thrice till the completion of induction or recovery of ANC >1000/MM3 or development of fungal infection
16303256|NCT00624130|Drug|Yasmin 20|Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
16303257|NCT00624130|Drug|Mercilon|Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
16303258|NCT00624117|Behavioral|Progressive exercise|home-based exercise program, 2 to 3 exercise sessions per week
16303259|NCT00624104|Dietary Supplement|Food (fat free meal)|Fat free meal (40% of REE)
16303260|NCT00624091|Procedure|Cardiac surgery|Cardiac surgery within 48 hours of randomization
16303261|NCT00624091|Procedure|State-to-the-art treatment|Antibiotic treatment and surgery if emergency or sequelae of endocarditis as recommended in the guidelines
16303262|NCT00624078|Drug|Antivenin Centruroides (scorpion) F(ab)2 Anascorp™|three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.
16303263|NCT00624065|Drug|carvedilol controlled release/lisinopril|carvedilol CR + lisinopril given as separate pills
16303264|NCT00624065|Drug|lisinopril + placebo|lisinopril plus placebo to match carvedilol CR
16303265|NCT00624052|Drug|fixed-dose combination of telmisartan 40mg+amlodipine 10mg|
16303266|NCT00624052|Drug|fixed-dose combination of telmisartan 80mg+amlodipine10mg|
16303267|NCT00624039|Other|UBM with pilocarpine in presbyopia|ultrasound biomicroscopic examination in both eyes 30 minutes after one drop of 2% pilocarpine hydrochloride (Ocucarpine®, Samil Pharm., Seoul, Korea) instillation before and two months after cataract surgery
16303268|NCT00624026|Drug|Memantine-HCl|20 mg per day (once daily)
16303269|NCT00624013|Drug|sertraline|50 mg up to 100 mg daily for 6 months
16303270|NCT00624013|Drug|Placebo|50 mg up to 100 mg daily for 6 months
16303271|NCT00624000|Drug|IV tpa (Alteplase) vs IA tpa (Alteplase)|Alteplase was administered Either IA or IV x 1
16303272|NCT00623987|Drug|warfarin accordingly INR value|warfarin accordingly to INR value between 2.0-3.0
16303273|NCT00623974|Drug|Teriparatide (Forteo)|Subcutaneous Injection Every 12 Hours for 7 Days
16303274|NCT00623974|Drug|Calcium|1000 milligrams by mouth (PO) Every 12 Hours
16303275|NCT00623974|Drug|Calcitriol|0.25 micrograms PO Every 12 Hours
16303276|NCT00623948|Device|A fully implanted gluteal stimulation (GSTIM) system|A fully implanted gluteal stimulation system
16303277|NCT00623935|Drug|Fludarabine|Fludarabine (40 mg/m2/day x 4 days)
16303278|NCT00623935|Drug|Busulfan|Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
16303279|NCT00623935|Radiation|Total Body Irradiation|Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.
16303280|NCT00623935|Procedure|Stem Cell Transplant|Allogeneic stem cell transplant from related or unrelated donor
16303281|NCT00623922|Behavioral|Patient education with individual nurse consultations|3 group meetings followed by 1-2 individual nurse consultations.
16303282|NCT00623909|Device|AvicennaTM class IV laser application|AvicennaTM class IV laser for application over the skin of human subjects in the treatment of post-thoracotomy pain syndrome. Six sessions, twenty minutes applications over a period of six weeks.
16303283|NCT00623883|Procedure|Surgical removal of ACF|All ACF removed by either cold or hot colonoscopic biopsy forceps
16303284|NCT00623883|Procedure|Colonoscopic evaluation only|Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year
16303285|NCT00623870|Drug|RO5045337|Multiple ascending doses
16303286|NCT00623857|Dietary Supplement|Zinc|Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
16303287|NCT00623857|Dietary Supplement|Vitamins and minerals other than zinc|Daily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
16303288|NCT00623857|Dietary Supplement|Vitamins plus zinc and other minerals|Daily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
16303289|NCT00623857|Dietary Supplement|Placebo|Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks
16303290|NCT00623844|Behavioral|physical activity|activity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families
16303291|NCT00623831|Biological|Mixed bacterial vaccine|MBV was administered twice weekly by subcutaneous injection in Cohort 1 and by intralesional (preferred) or subcutaneous (if intralesional not possible) injection in Cohort 2. In Cohort 1, the MBV starting dose was 250 EU (dose level 1) with possible intrasubject escalations up to 547,000 EU (dose level 8). In Cohort 2, all subjects received MBV at a fixed dose of 60,800 EU (dose level 6).
16303292|NCT00623805|Drug|Bevacizumab|Bevacizumab was supplied as a solution in single-use vials.
16303293|NCT00623805|Drug|Capecitabine|Capecitabine was supplied as film-coated tablets.
16303294|NCT00623805|Drug|Oxaliplatin|Oxaliplatin was supplied as a lyophilized powder in vials.
16303295|NCT00623792|Behavioral|Preoperative lifestyle Intervention|"6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 booster telephone calls after surgery"
16303296|NCT00623779|Drug|AZD0837|ER formulation
16303297|NCT00623779|Drug|Aspirin|Oral form
16303298|NCT00623766|Drug|Ipilimumab|10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance
16303299|NCT00623766|Drug|Corticosteroid: Betamethasone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone
16303300|NCT00623766|Drug|Corticosteroid: Dexamethasone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with dexamethasone
16303301|NCT00623766|Drug|Corticosteroid: Fludrocortisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with fludrocortisone
16303302|NCT00623766|Drug|Corticosteroid: Hydrocortisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with hydrocortisone
16303303|NCT00623766|Drug|Corticosteroid: Meprednisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with meprednisone
16303555|NCT00621998|Drug|risperidone|0.5-6 mg/day
16303304|NCT00623766|Drug|Corticosteroid: Methylprednisolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with methylprednisolone
16303305|NCT00623766|Drug|Corticosteroid: Prednisolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisolone
16303306|NCT00623766|Drug|Corticosteroid: Prednisone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisone
16303307|NCT00623766|Drug|Corticosteroid: Triamcinolone|Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with triamcinolone
16303308|NCT00623753|Biological|EnvDNA, PolyEnv1, EnvPro|Description: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6.
16303309|NCT00623740|Drug|hydrocortisone|Intravenous slow of hemisuccinate hydrocortisone 0.5 mg/kg/12 hours during 7 days then 0.5mg/kg/24 hours during 3 days.
16303310|NCT00623740|Drug|placebo|intravenous slow of placebo 0.5mg/kg/12 hours during 7 days then 0.5 mg/kg/24 hours during 3 days
16303311|NCT00623727|Biological|rFVIII-FS/pegylated liposomes (BAY79-4980)|35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm
16303312|NCT00623727|Biological|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight intravenous 3x/week for 52 weeks
16303313|NCT00623714|Drug|Comparator: fluticasone|Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
16303314|NCT00623714|Drug|Placebo|Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
16303315|NCT00623701|Biological|Allerslit forte|sublingual placebo preparation, daily
16303316|NCT00623701|Biological|Allerslit forte|Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
16303317|NCT00623688|Device|Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC)|Albuterol is delivered by metered dose inhaler with valved holding chamber. For children less than 6 years of age, a mask is also used.
16303318|NCT00623688|Device|Airlife Sidestream High Efficiency Nebulizer|Albuterol is delivered as a mist mixed with normal saline using a nebulizer machine and face mask or mouth piece.
16303319|NCT00623675|Dietary Supplement|Mineralox C|Mineralox C 2 capsules three times a day.
16303320|NCT00623662|Other|Preoperative glucose infusion|Glucose infusion from 15:00 on the day before the operation until beginning of surgery.
16303321|NCT00623662|Other|Preoperative normal saline infusion|Normal saline infusion from 15:00 on the day before surgery until beginning of the operation.
16303322|NCT00623649|Drug|VCH 916|Dose escalation study with a full review of all safety data following each cohort.
16303323|NCT00623649|Drug|Placebo|Dose escalation study with a full review of all safety data following each cohort.
16303324|NCT00623636|Drug|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
16303325|NCT00623636|Drug|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
16303326|NCT00623623|Procedure|primary PCI|Standard primary PCI
16303327|NCT00623623|Drug|enoxaparin|Adjunctive treatment
16303328|NCT00623623|Procedure|catheterisation|Routine or rescue coronary intervention
16303329|NCT00623623|Drug|tenecteplase|Single, weight-adjusted i.v. bolus of tenecteplase
16303330|NCT00623623|Drug|clopidogrel|Adjunctive treatment
16303331|NCT00623610|Procedure|islet cell grafts|Intraportal injection of an islet cell graft into the liver.
16303332|NCT00623597|Drug|ritonavir|2.5-3.0mg/kg po bid (starting dose) for 48 weeks
16303333|NCT00623597|Drug|saquinavir [Invirase]|50mg/kg po bid (starting dose) for 48 weeks
16303334|NCT00623584|Procedure|Corneal transplantation|Full thickness penetrating keratoplasty
16303335|NCT00623584|Procedure|Corneal transplantation|Full thickness penetrating keratoplasty
16303336|NCT00623571|Other|Treatment of elderly patients in a GMW|
16303337|NCT00623571|Other|Treatment of elderly patients in GHHS|
16303338|NCT00623558|Drug|Cetuximab|400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
16303339|NCT00623558|Drug|Docetaxel|75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
16303340|NCT00623558|Drug|Cisplatin|75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
16303341|NCT00623545|Drug|Exenatide|Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
16303342|NCT00623532|Behavioral|Mind-body exercises|
16303343|NCT00623532|Behavioral|Adapted Tai-chi|
16303344|NCT00623506|Drug|Pregnenolone|"Placebo for two weeks (during placebo lead-in), then:
~Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
16303345|NCT00623506|Drug|Placebo|"Placebo for two weeks (placebo lead in), then:
~Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)"
16303426|NCT00622947|Procedure|right temporal low frequency (1 hz) rTMS|Right temporal low frequency (1 hz) rTMS.
16303427|NCT00622947|Procedure|Sham-rTMS|The coil is angled 90 degrees away from the scalp
16303346|NCT00623480|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
16303347|NCT00623480|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Treated according to the Kogenate FS package insert indications and study physician recommendations
16303348|NCT00623467|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
16303349|NCT00623454|Behavioral|Cognitive behaviour therapy|Three hours with cognitive therapy focusing on the chest pain and palpitations.
16303350|NCT00623441|Device|Endeavor Zotarolimus Eluting Coronary Stent|Drug eluting stent
16303351|NCT00623428|Drug|peginterferon alfa-2a|
16303352|NCT00623428|Drug|Ribavirin|
16303353|NCT00623415|Drug|Flupirtine|300 mg daily (divided in two doses)
16303354|NCT00623415|Drug|Placebo|twice daily
16303355|NCT00623402|Drug|Sorafenib|2x 400 mg orally per day (4 tablets)
16303356|NCT00623402|Drug|pegylated interferon α-2b|3 µg/kg body weight s.c. once a week
16303357|NCT00623389|Device|IST-16 (16-channel implanted stimulator-telemeter)|Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
16303358|NCT00623376|Drug|nabilone then placebo|The subjects were first on Nabilone, then crossed over to placebo
16303359|NCT00623376|Drug|placebo then nabilone|the subjects were first on placebo then crossed over to nabilone
16303360|NCT00623363|Drug|piclozotan|piclozotan, intravenous (IV) infusion
16303361|NCT00623363|Drug|0.9% sodium chloride (normal saline)|0.9% sodium chloride (normal saline) intravenous (IV) infusion
16303362|NCT00623350|Other|Telephone|Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
16303363|NCT00623350|Other|Two way audio/video telemedicine consult|Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
16303364|NCT00623337|Behavioral|Home visits|Home visits by community based surveillance volunteers (2 during pregnancy & 3 during 1st week of life) to promote facility delivery, careseeking during pregnancy and childbirth and essential newborn care practices and to identify & refer sick babies
16303365|NCT00623324|Drug|Aplindore|Tablets .05 - 5 mg BID dosing for 14 days
16303366|NCT00623324|Drug|Placebo|Placebo tablets to match the number of active tablets
16303367|NCT00623298|Behavioral|Narrative Exposure Therapy|
16303368|NCT00623298|Behavioral|group IPT|
16303369|NCT00623298|Other|6 months-baseline|
16303370|NCT00623285|Drug|Pregabalin|Pregabalin 150mg orally 60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive 150mg twice a day through the first 2 post-operative days for a total of six doses.
16303371|NCT00623285|Drug|Placebo/Lactose|Matching Placebo orally,60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive placebo twice a day through the first 2 post-operative days for a total of six doses. If the patient is unable to swallow and NG tube is in place, the medication can be dissolved in water and administered through the NG tube.
16303372|NCT00623272|Other|compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)|To compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction.
16303373|NCT00623259|Biological|MVA-mBN120B|
16303374|NCT00623246|Behavioral|MET|MET will involve motivational counseling sessions and phone calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns based on CPAP adherence monitoring.
16303375|NCT00623246|Behavioral|ED|ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
16303376|NCT00623233|Drug|Gemcitabine|Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.
16303377|NCT00623233|Drug|Bevacizumab|"Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event [AE], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.)
~Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
16303378|NCT00623220|Other|N2O|EMONO
16303379|NCT00623220|Other|oxygen|oxygen
16303380|NCT00623207|Drug|Atropine|I.V Atropine 0.5mg up to 2 mg
16303381|NCT00623194|Drug|insulin detemir|Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
16303382|NCT00623194|Drug|insulin aspart|Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
16303383|NCT00623181|Biological|Fluzone: Influenza virus vaccine|0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
16303384|NCT00623181|Biological|Fluzone: Influenza virus vaccine|0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
16303385|NCT00623168|Drug|Ribavirin|7 Day multiple dosing regime based on weight and dosage day
16303386|NCT00623155|Drug|Seasonal IPT in children - Sulfadoxine-pyrimethamine|Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
16303387|NCT00623142|Drug|Hyperbaric Oxygen|100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG
16303388|NCT00623129|Other|questionnaire administration|
16303389|NCT00623129|Procedure|electroacupuncture therapy|
16303390|NCT00623129|Procedure|management of therapy complications|
16303391|NCT00623129|Procedure|quality-of-life assessment|
16303392|NCT00623116|Drug|Short withdrawal of testosterone, gonadotropins or estrogenic compounds (see below)|clinical examination, biochemical profile, and genetic characterization. Possibility to stop hormone therapy with drugs containing testosterone (Atmos®, Testim®, Testogel®, Nebido®, Panteston®, Sustanon®), FSH (Gonal-F®, Puregon®), hCG (Pregnyl®), estrogenic compounds (such as Estrofem®, Divigel®, Estrena®, Climara®, Estradot®, Evorel®, Femseven®: Merimono®, Progynova®, Ovestin®, Zumenon®, Estrogel®, Femoston®, Femoston combi®, Divina®, Divitren®, Indivina®, Estalis sekvens®, Evorel sequi®, Novofem®, Trisekvens®, Activelle®, Estalis®, Evorel conti®, Kliogest®, Mericomb®, Mericomb Mite®, Merigest®: Angeliq®) for 3 mo to assess reversibility of GnRH-deficiency will be offered.
16303393|NCT00623103|Drug|Rivastigmine capsule|Rivastigmine capsules orally twice a day. Target dose 12 mg/day.
16303394|NCT00623103|Drug|Rivastigmine transdermal patch|Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm^2/day delivering 9.5 mg over a 24 hour period.
16303395|NCT00623090|Behavioral|educational internet site on prostate cancer screening|Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.
16303396|NCT00623090|Behavioral|Educational print booklet|Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
16303397|NCT00623090|Behavioral|Usual care|Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
16303398|NCT00623077|Biological|filgrastim|"Beginning 24 hours after chemotherapy end: 10 microgram/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophile count (ANC) > 1,000/mm^2.
~Starting that day, increase dose to 15 microgram/kg/day SQ or IV given as a single injection for 3 doses."
16303399|NCT00623077|Drug|busulfan|Part of pre-transplant conditioning chemotherapy: Administered as Busulfan 9.6 mg/kg IV (>4 yrs of age) or 13.2 mg/kg IV (< 4 years of age),every 6 hours on Days -8 through -6.
16303400|NCT00623077|Drug|etoposide|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 100 mg/m^2/day intravenous (IV) over 1 hour for 5 days.
16303401|NCT00623077|Drug|ifosfamide|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m^2/day intravenous (IV) over 1 hour on for 5 days.
16303402|NCT00623077|Drug|melphalan|Part of pre-transplant conditioning chemotherapy: Administered as 100 mg/m^2 intravenous (IV) over 30 min on Days -5 through -4.
16303403|NCT00623077|Drug|thiotepa|Part of pre-transplant conditioning chemotherapy: Administered as 500 mg/m^2 intravenously (IV) over 2 hrs on Days -3 through -2.
16303404|NCT00623077|Procedure|stem cell transplantation|Regardless of whether the patient will be receiving peripheral cells or bone marrow, infusion will be intravenous on day 0, immediately after thawing.
16303405|NCT00623077|Radiation|tomotherapy|"We plan to deliver the total marrow irradiation (TMI) to the upper half of the body using Tomotherapy TMI as explained in this protocol. However the lower part of the body will be treated with Anterior/Posterior linac based radiation treatment. Tomotherapy will then be delivered at a dose rate so as to keep the total treatment time to no more than 30 minutes. We anticipate that the dose rate will be around 400 cGy
~/minute (instantaneous dose rate)."
16303406|NCT00623077|Radiation|total marrow irradiation|"TMI will be delivered to all bony sites as part of the conditioning. Additional spot therapy to PET positive lesions, primary disease (if not previously irradiated to maximum tolerated dose), and lungs will be performed on Day +60. Cohorts of 3 patients will be treated at a total dose of 600 cGy, 900 cGy or 1200 cGy on Days -11 through -9."
16303407|NCT00623077|Drug|Mesna|Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m^2/day divided in every 6 hrs dosing for 5 days.
16303408|NCT00623077|Radiation|Whole lung radiation|At Day 60, patients with prior lung metastasis should receive whole lung irradiation (1500cGy in 10 fractions).
16303409|NCT00623064|Drug|cisplatin|
16303410|NCT00623064|Drug|gemcitabine hydrochloride|
16303411|NCT00623064|Drug|lapatinib ditosylate|
16303412|NCT00623064|Other|pharmacological study|
16303413|NCT00623051|Procedure|Male Circumcision|
16303414|NCT00623025|Drug|Creon 25000|6 to 9 capsules Creon 25000 per day
16303415|NCT00623025|Drug|Placebo|6 to 9 capsules placebo per day
16303416|NCT00623012|Drug|Rapamycin|Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
16303417|NCT00623012|Drug|Tacrolimus|Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks.
16303418|NCT00622986|Drug|an extract of Cimicifuga Foetida L.|Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
16303419|NCT00622986|Drug|an extract of Cimicifuga Foetida L.|Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
16303420|NCT00622986|Drug|placebo|Each patient will be given placebo of 2 tablets each day for 3 months.
16303421|NCT00622986|Drug|placebo|Each patient will be given placebo of 2 tablets each day for 3 months.
16303422|NCT00622973|Other|Imaging: diffusion-weighted MRI|Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
16303423|NCT00622973|Other|Sinerem (USPIO) enhanced MRI|USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.
16303424|NCT00622960|Other|High-MUFA diet|The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
16303425|NCT00622960|Other|High-CHO diet|The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
16303430|NCT00622921|Behavioral|Couples-based behavioral psychotherapy|12 weeks of Couples-based behavioral psychotherapy
16303431|NCT00622908|Drug|ISV-403|0.6% TID, 5 days
16303432|NCT00622908|Drug|Vehicle|Vehicle of ISV-403 TID, 5 days
16303433|NCT00622895|Drug|fludarabine phosphate|Given IV
16303434|NCT00622895|Drug|Mycophenolic Acid|Given PO
16303435|NCT00622895|Drug|tacrolimus|Given PO
16303436|NCT00622895|Radiation|total-body irradiation|Undergo TBI
16303437|NCT00622895|Procedure|bone marrow transplantation|Undergo transplantation
16303438|NCT00622895|Procedure|reduced intensity allogeneic hematopoietic stem cell transplantation|Undergo transplantation
16303439|NCT00622895|Procedure|quality-of-life assessment|Ancillary studies
16303440|NCT00622895|Other|laboratory biomarker analysis|Correlative studies
16303441|NCT00622895|Other|flow cytometry|Correlative studies
16303442|NCT00622895|Procedure|biopsy|Punch biopsy of skin involved with scleroderma
16303443|NCT00622882|Other|infectious disease specialist consultation|Randomised trial to determine the utility of an early Infectious disease Consultation in Staphylococcus aureus bacteremic patients ( in the first 48 hours of a positive blood culture)
16303444|NCT00622869|Drug|Tacrolimus (reduced tacrolimus)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization, a level which was maintained for the duration of the study.
16303445|NCT00622869|Drug|Tacrolimus (tacrolimus elimination)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization. Tacrolimus elimination was started beginning at Month 4. Tacrolimus was tapered after everolimus whole blood trough levels were within the target range of 6-10 ng/mL. Tacrolimus was completely eliminated by the end of Month 4.
16303446|NCT00622869|Drug|Tacrolimus (tacrolimus control)|Tacrolimus trough levels were targeted to be maintained at 8-12 ng/mL until Month 4. At Month 4, tacrolimus whole blood trough levels were decreased to a target trough level of 6-10 ng/mL for the remainder of the study.
16303447|NCT00622869|Drug|Everolimus (reduced tacrolimus)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL for the duration of the study.
16303448|NCT00622869|Drug|Everolimus (tacrolimus elimination)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL until Month 4; beginning with Month 4, the dose was adjusted to maintain everolimus trough blood levels between 6-10 ng/mL.
16303449|NCT00622869|Drug|Corticosteroids|For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids could be used for the duration of the study but could not be eliminated before Month 6.
16303450|NCT00622856|Behavioral|psychological intervention|Psychological intervention
16303451|NCT00622856|Behavioral|Diabetes education|5 sessions with diabetes nurse
16303452|NCT00622843|Biological|pneumococcal conjugate vaccine|"Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain:
~2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension."
16303453|NCT00622843|Biological|pneumococcal polysaccharide vaccine|PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
16303454|NCT00622830|Drug|SB-480848 (Darapladib)|
16303455|NCT00622817|Drug|xylometazoline HCL 0.05%|Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
16303456|NCT00622817|Drug|Epinephrine 1mg|Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
16303457|NCT00622804|Procedure|Billroth-II (B-II)|After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.
16303458|NCT00622804|Procedure|Roux en Y gastrojejunostomy (RY-GJ)|After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.
16303459|NCT00622804|Procedure|uncut Roux en Y gastrojejunostomy|After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.
16303460|NCT00622765|Drug|placebo|Placebo capsule twice daily
16303461|NCT00622765|Drug|R256918|5 mg capsule twice daily
16303462|NCT00622765|Drug|R256918|10 mg capsule twice daily
16303463|NCT00622765|Drug|R256918|15 mg capsule twice daily
16303464|NCT00622752|Drug|EVT 302, 10 mg|2 X EVT 302, 5 mg tablets
16303465|NCT00622752|Drug|placebo|2 X placebo tablets to match EVT 302 5 mg
16303466|NCT00622752|Drug|Nicotine replacement therapy (NRT)|NRT patch containing 21 mg of nicotine
16303467|NCT00622752|Device|NRT placebo|Medically inert plaster cut to match the NRT plaster
16303556|NCT00621998|Drug|olanzapine|2.5-20 mg/day
16303468|NCT00622739|Drug|Ziprasidone|Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
16303469|NCT00622739|Drug|Ziprasidone|Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
16303470|NCT00622726|Drug|Bevacizumab|Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
16303471|NCT00622726|Procedure|Conventional Laser for ROP|Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
16303472|NCT00622713|Drug|Rivastigmine transdermal patch|The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
16303473|NCT00622700|Drug|Teriflunomide|Film-coated tablet Oral administration
16303474|NCT00622700|Drug|Placebo|Film-coated tablet Oral administration
16303475|NCT00622687|Drug|iloprost|0.5-2 ng/kg x min for 6hours a day for 21 consecutive days
16303476|NCT00622687|Drug|iloprost low dose|0.5 ng/kg x min over 6 h per day for 21 consecutive days
16303477|NCT00622687|Drug|iloprost therapy up to 2 ng/kg x min|starting therapy at doses of 0.5 ng/kg x min, increase the dose every two days for 0.5 ng/kg x min up to the maximally tolerated dose or to 2 ng/kg x min
16303478|NCT00622674|Biological|cetuximab|A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
16303479|NCT00622674|Drug|bortezomib|The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
16303480|NCT00622661|Other|Low Glycemic Load Diet|consume both high and low glycemic load diets for 28 days each
16303481|NCT00622661|Other|High Glycemic Load Diet|consume both high and low glycemic load diets for 28 days each
16303482|NCT00622648|Drug|Enoxaparin|40 mg once daily for 6 to 14 days (10 ± 4 days)
16303483|NCT00622648|Drug|Placebo|Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
16303484|NCT00622635|Drug|Indacaterol 300 μg|Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
16303485|NCT00622635|Drug|Placebo to indacaterol|Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
16303486|NCT00622635|Drug|Salmeterol 50 μg|Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).
16303487|NCT00622622|Biological|VEGFR2-169 and gemcitabine|Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.
16303488|NCT00622609|Drug|GSK249320A|GSK249320A intravenous infusion will be formulated as 100 milligrams/milliliters in 2 milliliters vials (filled to 1 milliliter), in phosphate buffer and delivered by a syringe and programmable pump.
16303489|NCT00622609|Drug|Placebo|Sodium chloride intravenous infusion will be given as matching placebo.
16303490|NCT00622596|Other|Mobile Access|Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.
16303491|NCT00622570|Drug|Pentobarbital|10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
16303492|NCT00622570|Drug|thiopental|"2 mg/kg in bolus; if ICP is not below 20 mmHg then 3 mg/kg in bolus; if ICP is not below 20 mmHg it can be administrated a third bolus of 5 mg/kg.
~Maintenance: 3 mg/kg/h in perfusion"
16303493|NCT00622531|Device|BNP assay (Siemens ADVIA Centaur BNP)|Diagnostic test
16303494|NCT00622531|Other|hidden BNP value|no intervention
16303495|NCT00622518|Drug|Hyland's earache drops|3-4 drops in affected ear 3 times a day as needed for up to 5 days
16303496|NCT00622505|Drug|zoledronic acid|Zoledronic acid concentrate (4 mg/5 milliliters [ml]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
16303497|NCT00622492|Other|echocardiography Doppler sonography, blood and urine sampling|data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
16303498|NCT00622479|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib will be administered at 400mg BID for a 28 day cycle.
16303499|NCT00622466|Drug|paclitaxel|The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
16303500|NCT00622466|Drug|sorafenib tosylate|Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
16303501|NCT00622453|Other|Screening|Electrocardiography Blood Test
16303502|NCT00622440|Drug|AIJP (Arnebia Indigo Jade Pearl)|Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
16303503|NCT00622440|Drug|Placebo|Placebo twice daily for 48 weeks.
16303504|NCT00622427|Drug|Ramelteon|8 mg tablets every night for 2 weeks
16303505|NCT00622427|Drug|Placebo|placebo tablets for every night for 2 weeks
16303506|NCT00622414|Biological|ziv-aflibercept|Given IV
16303507|NCT00622401|Biological|Dendritic Cell/Tumor Fusion Vaccine|Vaccine is derived from the participants dendritic cells and tumor cells
16303508|NCT00622401|Drug|Interleukin-12|Given subcutaneously at dose of 30ng/kg
16303509|NCT00622401|Drug|Interleukin-12|Given subcutaneously at dose of 100ng/kg
16303510|NCT00622388|Drug|Ofatumumab|8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
16303512|NCT00622362|Biological|DEPIGOID Dermatophagoides pteronyssinus|Subcutaneous administration:0.5 ml/month during 1 year
16303513|NCT00622362|Biological|Polymerized TOL of Dermatophagoides pteronyssinus|Sublingual immunotherapy. Two drops daily during 1 year
16303514|NCT00622362|Biological|Placebo Comparator|Sublingual immunotherapy. Two drops daily during 1 year
16303515|NCT00622349|Drug|Cisplatin, Ifosfamide, Gemcitabine|Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
16303516|NCT00622349|Drug|Ifosfamide, Gemcitabine|Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
16303517|NCT00622349|Drug|Cisplatin, docetaxel|Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
16303518|NCT00622336|Drug|CC-5013|Oral 25mg daily on Days 1-21 every 28 days.
16303519|NCT00622336|Drug|Lenalidomide|Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.
16303520|NCT00622310|Behavioral|Walking exercise|Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
16303521|NCT00622284|Drug|Placebo identical to BI 1356 5mg|Placebo tablet once daily
16303522|NCT00622284|Drug|Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg|Placebo tablets once daily
16303523|NCT00622284|Drug|BI 1356|5mg, once daily in the morning for 104 weeks
16303524|NCT00622284|Drug|Glimepiride|1mg or 2mg or 3mg or 4mg in the morning for 104 weeks
16303525|NCT00622271|Behavioral|Group Therapy|Self-management Group Protocol: The parent sessions will be structured by general topic area, but teaching of clinical and behavioral information will be derived from questions and problems posed by the group in order to actively meet the needs and concerns of participants. The parent sessions will be an interactive process of eliciting concerns and questions, presenting information to address those questions, and following up with a discussion to review concerns and strategies to address the behavioral aspects of the issues. The child sessions will be activity focused, with hands-on opportunities to practice the skills being taught.
16303526|NCT00622258|Drug|Everolmus|
16303527|NCT00622245|Drug|Lu AA34893|per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
16303528|NCT00622245|Drug|Quetiapine fumarate|per oral, once daily, during 12 weeks, followed by a one-week tapering period
16303529|NCT00622245|Drug|Placebo|per oral doses, twice daily as capsules during 13 weeks
16303530|NCT00622232|Genetic|VRX496-transduced autologous CD4 T cells|The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
16303531|NCT00622219|Other|Randomized Drug Testing Trial|Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).
16303532|NCT00622206|Drug|ritonavir and saquinavir|saquinavir/ritonavir 1500/100 mg or 1500/50 mg Twenty HIV-infected volunteers on stable doses of SQV/RTV 1500/100 mg OD for at least 3 months with an NRTI backbone and undetectable viral load will participate. After collecting samples for a full PK curve subjects will be switched to SQV/RTV 1500 /50 mg OD + 2NRTIs for 1 week before repeating the PK assessment. Blood samples will be drawn at T 0, 1, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion. Consecutively to the assessment, subjects will return to SQV/RTV 1500/100 mg OD dosage.
16303533|NCT00622193|Drug|anamorelin HCl|50 mg tablet
16303534|NCT00622193|Drug|anamorelin HCl|100 mg tablet
16303535|NCT00622193|Drug|placebo|placebo tablet
16303536|NCT00622180|Device|NBUVB|NBUVB hand foot box
16303537|NCT00622180|Device|Monochromacitc Excimer light|Treatment with Monochromacitc Excimer light
16303538|NCT00622167|Device|Integrated Backscatter IVUS|All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
16303539|NCT00622167|Device|Dual Source Computed Tomography|All subjects have DSCT and IBIVUS imaging
16303540|NCT00622141|Drug|generic GPO saquinavir and novir vs invirase and norvir|Norvir® 100mg capsules, Invirase® 1,000 mg capsules Generic GPO Saquinavir 1,000 mg capsules For phase 1 and 2 - At day 1 subjects of group A will receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg, while group B will receive generic GPO saquinavir / Norvir® 1,000 mg / 100mg as single dose. The same day the first 24 hr PK curve will be done. After this, a 7-day washout period will follow. At day 8 group A will take generic GPO saquinavir / Norvir® and Group B will take Invirase®/Norvir®. At this day, the second 24 hr PK curve will be done
16303541|NCT00622128|Behavioral|Preventing Aggressive Behavior in Demented Patients|Preventing Aggressive Behavior in Demented Patients
16303542|NCT00622115|Drug|Enoxaparin|
16303543|NCT00622102|Behavioral|Lottery arm (Lottery and Med-eMonitor)|Lottery and Med-eMonitor
16303544|NCT00622102|Behavioral|Non-Lottery (Med-eMonitor only)|Med-eMonitor only
16303545|NCT00622089|Drug|DIO-902|150mg DIO-902 + 10mg atorvastatin
16303546|NCT00622089|Drug|DIO-902|300mg dose once per day for 24 weeks
16303547|NCT00622089|Drug|DIO-902|450mg dose once per day for 24 weeks
16303548|NCT00622076|Procedure|postoperative catheterization|postoperative catheterization after anterior colporrhaphy for five days versus two days.
16303549|NCT00622063|Drug|ARQ 501|Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received
16303550|NCT00622050|Behavioral|No TV viewing reduction|In the control group, no intervention will be acted upon. This group will receive the exact same protocol as the intervention group, but with observation only.
16303551|NCT00622050|Behavioral|TV viewing reduction|In the experimental arm, TV viewing time will be reduced for half of the study protocol time (3-4 weeks of a 6-8 week protocol).
16303552|NCT00622037|Drug|PEG-400 based artificial tear|Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
16303553|NCT00622037|Drug|Systane|Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
16303554|NCT00622011|Drug|Risperidone and Zotepine for delirium|try risperidone or zotepine in the treatment of delirium
16303557|NCT00621985|Drug|dexamethasone|Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.
16303558|NCT00621985|Drug|Hydrocortisone|Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.
16303559|NCT00621959|Drug|levocetirizine dihydrochloride|5mg daily (oral tablet) for 14 days
16303560|NCT00621959|Drug|placebo|0mg (matching oral tablet)for 14 days
16303561|NCT00621946|Drug|Placebo|Placebo Matching Escitalopram
16303562|NCT00621946|Drug|Escitalopram|Active Escitalopram
16303563|NCT00621920|Drug|FM-601|Dose-escalation, split dosage, liquid
16303564|NCT00621907|Drug|chirocaine (Levobupivacaine)|levobupivacaine 0,5 % 30 ml infiltration (150 mg)
16303565|NCT00621907|Drug|sodium chloride|sodium chloride : 0,9% 30 ml
16303566|NCT00621894|Drug|LGD-4665|LGD-4665 Thrombopoietin mimetic
16303567|NCT00621894|Drug|Placebo|Placebo
16303568|NCT00621881|Drug|naproxcinod|750 mg bid
16303569|NCT00621868|Drug|ipragliflozin|Oral
16303570|NCT00621868|Drug|Placebo|Oral
16303571|NCT00621855|Drug|placebo|matched placebo
16303572|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
16303573|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
16303574|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
16303575|NCT00621855|Drug|dabigatran etexilate|capsules, twice daily, 26 weeks treatment
16303576|NCT00621842|Drug|Lamotrigine regular tablet formulation|Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
16303577|NCT00621842|Drug|Lamotrigine novel formulation|"Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.
~Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds."
16303578|NCT00621829|Dietary Supplement|EPA enriched fish oils|Subjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.
16303579|NCT00621829|Dietary Supplement|EPA enriched fish oils|Subjects will take a Placebo capsule for 90 days, followed by an 8 week washout period, and then will take the (EPA)-enriched omega-3 polyunsaturated fatty acids supplements as a capsule (3-4 g of EPA/day) for 90 days.
16303580|NCT00621816|Drug|nitroprusside|nitroprusside continuous infusion, dose to be titrated to clinical effect
16303581|NCT00621816|Drug|placebo infusion|blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion
16303582|NCT00621803|Drug|Probiotic Lactobacillus casei rhamnosus (Lcr35)|
16303583|NCT00621790|Drug|fenoldopam|fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
16303584|NCT00621790|Drug|placebo|placebo
16303585|NCT00621777|Drug|Varenicline|"At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
16303586|NCT00621777|Drug|Placebo|"At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.
~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
16303587|NCT00621764|Biological|Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
16303588|NCT00621764|Biological|Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)|0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
16303589|NCT00621764|Biological|Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
16303590|NCT00621764|Biological|Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)|0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
16303591|NCT00621751|Drug|Carbamazepine|800 mg daily
16303592|NCT00621751|Drug|Placebo|Placebo
16303593|NCT00621725|Drug|AZD2171|Oral dose
16303594|NCT00621712|Device|GamCath® central venous catheter|choice of catheter type
16303595|NCT00621712|Device|GamCath Dolphin® Protect central venous catheter|choice of catheter type
16303596|NCT00621699|Drug|1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
16303597|NCT00621699|Drug|1 capsule Prograf(R) (tacrolimus), Astellas Pharma GmbH, Germany|administration of 1 capsule Prograf(R) (5 mg tacrolimus), 0-144 h blood sampling
16303598|NCT00621699|Drug|1 tablet Ezetrol(R) + 1 capsules Prograf(R)|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 1 capsule Prograf(R) (5 mg Tacrolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
16303599|NCT00621686|Biological|bevacizumab|
16303600|NCT00621686|Drug|sorafenib tosylate|
16303601|NCT00621673|Drug|Kogenate (BAY 14-2222)|Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week
16303602|NCT00621660|Procedure|Acupuncture|"Acupuncture was administered bilaterally to the standard antiemetic point2-4 pericardium six (PC6) located between the tendons of palmaris longus and flexor carpii radialis at two body-inches proximal of the wrist crease. Sharp needles, diameter 0.25 x length 40 millimetres, were inserted into a depth of a half body-inch. One body-inch (or a cun in traditional Chinese medicine context) is equivalent to the greatest width of the individual patients´ thumb at the distal phalanx, approximately one and a half centimetres or one American thumb. The needles were manipulated three times (at the start, middle and end of the treatment session) by twirling, thrusting and lifting until deqi occurred."
16303603|NCT00621660|Procedure|Sham|Sham acupuncture was administered bilaterally to a non-acupuncture point two body-inches proximal of PC6 with the telescopic Park sham device16, 0.30 x 40 millimetres (fully extended length). That needle looks identical with a real needle but is blunted and glides upwards into its handle instead of penetrating, which gives an illusion of penetration. The marking tubes hold the needles in place. The therapist gave an illusion of manipulation by turning the needle three times, each time for a couple of seconds until the needle touched the skin, but no deqi occurred. Except when placing and manipulating the sham needle, it was not pressed against the skin at all.
16303604|NCT00621647|Drug|Quetiapine Fumarate|
16303605|NCT00621647|Drug|Quetiapine Fumarate|
16303606|NCT00621647|Drug|Placebo|
16303607|NCT00621634|Dietary Supplement|Omega-3 fish oil capsules (including DHA)|Fish oil capsules of 1000 mg ea., including DHA 460-540 mg/capsule 2 capsules TID daily at mealtime for 12 consecutive weeks
16303608|NCT00621634|Dietary Supplement|Placebo|Corn/Soybean (1:1) placebo 1000 mg capsules 2 capsules TID daily at mealtime for 12 consecutive weeks
16303609|NCT00621621|Device|Freezor® Cardiac Cryoablation Catheter CryoConsole System|cryoablation
16303610|NCT00621608|Procedure|Hyperbaric Oxygen Therapy|Hyperbaric Oxygen Therapy (HBOT) will be provided 5 days per week for 6 weeks for a total of 30 treatments on average. Subjects will be placed into the hyperbaric chamber for approximately 90 minutes of HBOT at 2.4 ATA (partial pressure of oxygen = 1,800 mmHg) when inside the chamber. Subjects will receive dressing changes as required per standard of care.
16303611|NCT00621608|Procedure|Placebo Hyperbaric Oxygen Chamber|Patients will receive HBOT placebo 5 days per week for 6 weeks for a total of 30 treatments. Each patient will be placed into the hyperbaric chamber and will receive 90 minutes of room air while inside the chamber and the initial flow of air into the chamber will produce a small increase in pressure (0.3 ATA partial pressure of oxygen = 210 mmHg) which will then be released over a period of 10 minutes. Subjects will receive dressings changes as required per standard of care.
16303612|NCT00621595|Dietary Supplement|USDA School Breakfast|Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.
16303613|NCT00621569|Behavioral|Dietary Approaches to Stop Hypertension-The DASH diet|The purpose of this study is to create a culturally appropriate diet to test the effectiveness of the intervention to lower blood pressure in a grou pof African American individuals at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).
16303614|NCT00621569|Behavioral|Intervention with no dietary component - information regarding useful life skills|Participants receive information regarding useful life skills in a group setting
16303615|NCT00621556|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
16303616|NCT00621543|Device|IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]|When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.
16303617|NCT00621530|Drug|ketorolac tromethamine opthalmic solution|ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery
16303618|NCT00621530|Drug|placebo|placebo will be added to the patient's routine spinal anesthetic for surgery
16303619|NCT00621517|Drug|Bupropion|Partipants will receive 150 mg bupropion per night
16303620|NCT00621517|Drug|Placebo|1 capsule nightly for six weeks
16303621|NCT00621504|Drug|Ceftaroline fosamil for Injection|2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
16303622|NCT00621504|Drug|IV Ceftriaxone|1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
16303623|NCT00621504|Drug|Placebo|Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
16303624|NCT00621504|Drug|Clarithromycin|In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
16303625|NCT00621491|Drug|Warfarin|Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
16303626|NCT00621478|Drug|lorazepam or diazepam|"Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing.
~The medication will be administered as a slow IV push."
16303627|NCT00621465|Behavioral|Critical Time Intervention (CTI)|CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care. CTI does not replace community treatment and support, but instead is meant to complement available services. CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community. Participants will receive CTI for 9 months after hospital discharge.
16303628|NCT00621465|Behavioral|Usual care|Usual care will include the standard aftercare and community care services.
16303629|NCT00621452|Biological|therapeutic autologous lymphocytes|Given IV
16303630|NCT00621452|Drug|cyclophosphamide|Given IV
16303631|NCT00621452|Biological|aldesleukin|Given subcutaneously
16303634|NCT00621452|Procedure|lymph node biopsy|Optional correlative studies
16303635|NCT00621452|Biological|genetically engineered lymphocyte therapy|Receive genetically modified T cells
16303636|NCT00621452|Procedure|bone marrow aspiration|Optional correlative studies
16303637|NCT00621452|Other|flow cytometry|Correlative studies
16303638|NCT00621452|Other|laboratory biomarker analysis|Correlative studies
16303639|NCT00621452|Other|enzyme-linked immunosorbent assay|Correlative studies
16303640|NCT00621439|Drug|Pegylated Interfon Alpha 2B|Patients will receive PEG-IFN 6 mcg/kg subcutaneously 4 days prior to surgery. Patients will be premedicated with acetaminophen 700 mb orally prior to the injection. Only one dose of drug will be given. Enucleation will follow in 4 days.
16303641|NCT00621439|Drug|Placebo|Patients will receive placebo.
16303642|NCT00621400|Drug|Lenalidomide|5 mg/day, orally for 21 days with 7 days rest (28 day cycle) for the first cohort; or 10mg/day, orally for 21 days with 7 days rest (28 day cycle) for the second cohort, 15mg/day, orally for 21 days with 7 days rest (28 day cycle) for the third cohort or 20mg/day, orally for 21 days with 7 days rest (28 day cycle) for the last and fourth cohort
16303643|NCT00621400|Drug|Melphalan|0,18mg/Kg/day from day 1- 4
16303644|NCT00621400|Drug|Dexamethasone|40mg/day from day 1- 4.
16303645|NCT00621387|Drug|ofloxacin and roxithromycin|150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
16303646|NCT00621387|Drug|placebo|placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
16303647|NCT00621374|Behavioral|Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)|There is also the possibility that the two treatments together may be even more helpful than either one alone. Because some of the patients in this study will get both CBT and self-hypnosis, we will be able to determine if each one facilitates the efficacy of the other. If the patients treated in this study report benefits, as we expect they will, then this will encourage us to design and complete a larger study to better understand how patients with MS would benefit from these treatments.
16303648|NCT00621374|Behavioral|Cognitive Behavioral Therapy (CBT)|"One treatment module is we will study is called cognitive restructuring or cognitive-behavior therapy (CBT). In this treatment, people learn to identify negative thoughts that make them feel bad or anxious. Such negative thoughts lead to feelings of frustration and anxiety, and can even increase the experience of pain, because they cause a person to focus more on pain. With CBT, people learn to identify and stop these thoughts, and then replace them with more reassuring ones. When they do this, they feel more relaxed and focus less on their pain. As a result, they often say that they feel much better and are less aware of pain."
16303649|NCT00621374|Behavioral|Self-Hypnosis Training (HYP)|Self-hypnosis (HYP) is another strategy that people can learn to manage pain. With this treatment, people learn to enter a state of focused attention, and then change how they experience pain. Although we do not yet know how hypnosis works, research has repeatedly shown that the effects are real; when people report decreases in pain with hypnosis, scans and images of the brain's activity show decreases in the parts of the brain that process pain information. With hypnosis, people are not just pretending to feel less pain, they actually do feel less pain.
16303650|NCT00621374|Behavioral|Education Control (CONT)|The CONT condition for this study will include lectures that are interactive and are compelling and informative enough to be both (1) credible as an attentional control condition and (2) perceived as helpful to subjects. The CONT condition will not, however, include instructions in making specific cognitive or behavioral changes related to pain management. Thus, it could control for non-specific factors related to behavioral treatment, but will not impact the primary outcome measure (pain).
16303651|NCT00621361|Drug|AZD2171|Oral
16303652|NCT00621361|Drug|Etoposide|Intravenous
16303653|NCT00621361|Drug|Cisplatin|Intravenous
16303654|NCT00621348|Drug|Isotonic fluid|0.9% saline with 5% dextrose at standard maintenance rate
16303655|NCT00621348|Drug|Hypotonic fluid|Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose
16303656|NCT00621348|Drug|Hypotonic fluid|N/5 saline in 5% dextrose at standard maintenance rate
16303657|NCT00621322|Biological|GSK Biologicals' AS01B adjuvant|Intramuscular injection, 2 doses
16303658|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1|Intramuscular injection, 2 doses
16303659|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2|Intramuscular injection, 2 doses
16303660|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3|Intramuscular injection, 2 doses
16303661|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1|Intramuscular injection, 2 doses
16303662|NCT00621322|Biological|GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2|Intramuscular injection, 2 doses
16303663|NCT00621309|Drug|Rifampicin|Rifampicin, an antibiotic used to treat TB, is administered at a dose of 300 mg day x 7 days to induce CYP3A5.
16303664|NCT00621309|Dietary Supplement|sulforaphane plus rifampicin|Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes. Sulforaphane is administered daily for 7 days as a broccoli sprout extract, at a dose rate of 75 mg (~420 umoles)per day for 7 days. Rifampicin is also administered once per day at a dose rate of 300 mg/day for 7 days.
16303665|NCT00621309|Dietary Supplement|sulforaphane alone|Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription factor, Pregnane X-Receptor (PXR). This arm tests the hypothesis that SFN can block ligand binding to the PXR, thereby inhibiting transcriptional activation of PXR-regulated genes
16303666|NCT00621296|Drug|MP-424 (Telaprevir)|Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
16303667|NCT00621283|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
16303668|NCT00621270|Drug|BCI-540|BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
16303669|NCT00621257|Dietary Supplement|ergocalciferol|8000 units/ml
16303670|NCT00621257|Dietary Supplement|Cholecalciferol|400 units per drop
16303671|NCT00621244|Drug|LBH589|
16303672|NCT00621231|Dietary Supplement|Placebo|Placebo
16303673|NCT00621231|Dietary Supplement|Protein|30 E% from protein
16303674|NCT00621218|Drug|tretinoin gel 0.05%|Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
16303675|NCT00621218|Drug|vehicle|Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
16303676|NCT00621205|Behavioral|Weight reduction, Resistance training, Aerobic exercise training, Control|Weight reduction: 12 weeks intensive weight loss, 20 weeks maintenance Resistance and aerobic exercise training: individualized and progressive training programs
16303677|NCT00621192|Drug|meropenem|"Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.
~20 mg/kg every 12 hours in infants <32 weeks GA and PNA < 2 weeks 20 mg/kg every 8 hours in infants <32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA < 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks"
16303678|NCT00621179|Drug|Leuprolide acetate in depot suspension|Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
16303679|NCT00621179|Other|No intervention|
16303680|NCT00621166|Drug|generic lopinavir/ritonavir|"Patients will start with lopinavir/ritonavir new formulation 400/100 mg bid with a low fat diet plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The choice of the 2 NRTIs is at the discretion of the investigator, though in general the use of zidovudine+lamivudine (300/150mg Combivir®) is recommended. If patients can be included at or before gestational week 20, a 12h pharmacokinetic curve will be recorded at week 20 (± 2 weeks)(Group 1). There should be a minimum of 2 weeks between start of lopinavir and pharmacokinetic recording. If they are included after week 20, the first 12h pharmacokinetic curve will be recorded at gestational week 33 (± 2 weeks)(Group 2). For the patients in both groups a 12 hr curve will be recorded.
~Subjects in Group 1 will be offered to conduct a second 12h pharmacokinetic curve at week 20 (± 2 weeks), but this is only optional. Both groups will be asked to participate in the post partum curve, again this is optional."
16303681|NCT00621153|Drug|Candesartan Cilexetil|Candesartan Cilexetil 16 mg oral
16303682|NCT00621153|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg
16303683|NCT00621153|Drug|Candesartan Cilexetil|Candesartan Cilexetil 32 mg oral
16303684|NCT00621140|Drug|linagliptin|active
16303685|NCT00621140|Drug|placebo|placebo
16303686|NCT00621114|Device|GamCath® central venous catheter|Choice of central venous catheter type
16303687|NCT00621114|Device|GamCath Dolphin® Protect central venous catheter|Choice of central venous catheter type
16303688|NCT00621101|Drug|1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
16303689|NCT00621101|Drug|1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany|administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling
16303690|NCT00621101|Drug|1 tablet Ezetrol(R) + 1 tablet Rapamune(R)|administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
16303691|NCT00621088|Procedure|Intertan|Operations performed either with a Sliding Hip Screw or a nail (Intertan)
16303692|NCT00621075|Other|Pulmonary Arterial Hypertension - Lung Perfusion Scans|Correlation of data from non-invasive tests such as lung perfusion scans with hemodynamic measurements
16303693|NCT00621062|Procedure|High Ligation of the GSV|Performed in local or general anesthesia in accordance to clinical praxis and the patients own preference. After high ligation the GSV is stripped from the groin to the most distant insufficient part or just under the knee joint.All proximal branches are ligated. Including the superficial epigastric vein. The stripping instrument can be inserted in either cranial or caudal direction but all veins are stripped in the cranio-caudal direction.
16303694|NCT00621062|Procedure|Endovenous Laser Ablation|Laser ablation is performed in tumescence anesthesia which is performed with a 150-200 ml (sometimes more is required, up to 400ml in patients with a poorly formed saphenous sheath) solution of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). Laser is performed under duplex guidance and the catheter is inserted percutaneously into the GSV at knee level and parked distant to the saphenofemoral junction (SFJ) just distal to the superficial epigastric vein. Laser ablation is performed down to the most distal insufficient part of GSV or just below the knee joint. We use an effect of 14 Watt administration of 70-80 J / cm at a continuous mode at a speed of 1cm/5sec.
16303695|NCT00621062|Procedure|Radiofrequency ablation|RF ablation is performed in tumescence anesthesia which is performed with a 150-200 ml solution (same as above) of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). RF is performed under duplex guidance and the Closure-FAST catheter is inserted percutaneously into the GSV at the knee level and parked distant to the SFJ just distal to the superficial epigastric vein. Probe size and length used for RF is chosen in accordance to the manufacturer's recommendation and with a probe temperature of 120 degrees C. RF closure is performed down to the most distal insufficient part of GSV or just under the knee joint.
16303696|NCT00621062|Procedure|Foam Sclerotherapy|Sclerosant foam consists of 2ml 3% aethoxysclerol mixed with 8ml air (Tessari method). A maximum of 10 ml is injected. Access to the vein for the sclerosant is gained by a duplex guided puncture or a mini incision mid-thigh or just above the knee and the amount of sclerosant foam used is 2,5-10 ml. Duplex is used prior to the operation in order to mark the vein and during the operation in order to control the extent of the sclerofoam. Duplex validates that foam is deposed to the whole length of the GSV. Blood from the veins is drained by means of elevation prior to the deposition of the sclerofoam. The leg is then bandaged with elastic bandage.
16303733|NCT00620854|Drug|Nasal Spray|200 IU recombinant salmon calcitonin, single intranasal spray
16303734|NCT00620841|Other|genotyping|Restriction fragment lenght polymorphisms
16303697|NCT00621049|Drug|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
~Docetaxel should be administered before carboplatin.
~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
~Maintenance Treatment for patients in Cohort A:
~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
16303698|NCT00621049|Drug|Docetaxel/Carboplatin|"Adjuvant Treatment Cohort B:
~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
~Docetaxel should be administered before carboplatin.
~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
16303699|NCT00621036|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16303700|NCT00621036|Biological|sargramostim|
16303701|NCT00621036|Drug|methotrexate|
16303702|NCT00621036|Drug|thiotepa|
16303703|NCT00621036|Radiation|radiation therapy|
16303704|NCT00621023|Drug|Decitabine, Arsenic Trioxide and Ascorbic Acid|Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles.
16303705|NCT00621010|Drug|CTS21166 (ZPQ-21166)|"Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B.
~Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion"
16303706|NCT00620997|Drug|Proparacaine drops 0.05%|topical, 0.05% drops, PRN continuously for up to 7 days
16303707|NCT00620997|Drug|saline drops|saline drops continuously PRN for up to 7 days
16303708|NCT00620971|Drug|Vinorelbine|Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
16303709|NCT00620971|Drug|Cisplatin|Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
16303710|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
16303711|NCT00620971|Drug|Docetaxel|Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
16303712|NCT00620971|Drug|Gemcitabine|Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
16303713|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
16303714|NCT00620971|Drug|Docetaxel|Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
16303715|NCT00620971|Drug|Cisplatin|Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
16303716|NCT00620971|Drug|Bevacizumab|Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
16303717|NCT00620958|Behavioral|Individual cognitive behavioral therapy (ICBT)|ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
16303718|NCT00620958|Behavioral|Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)|Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
16303719|NCT00620958|Behavioral|Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)|Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
16303720|NCT00620945|Drug|Phenoxybenzamine|"Use of Phenoxybenzamine:
~Loading dose given at the time of going on CPB:
~For patients with obstructing lesions on systemic side:
~0.25 mg/kg dose in the bypass circuit
~None intravenous
~For patients without obstructing left sided lesions:
~0.5 mg/kg in the bypass circuit
~0.5 mg/kg I.V. at cannulation
~Maintenance dose given in the post-operative period:
~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours
~0.3 mg/kg P.O. every 8 hours for next 24 hours
~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop
~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
16303721|NCT00620932|Behavioral|Exercise|Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.
16303722|NCT00620919|Drug|RG1068 (Synthetic Human Secretin)|Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
16303723|NCT00620906|Procedure|Manipulation|HVLA manipulation to Sacroiliac Joint
16303724|NCT00620893|Drug|PEG- 400 based artificial tear|Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily
16303725|NCT00620893|Drug|Systane|Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily
16303726|NCT00620880|Behavioral|Blood sample|
16303727|NCT00620867|Drug|Ibuprofen|800 mg oral tablet three time daily with meals for 6 weeks
16303728|NCT00620867|Drug|celecoxib|200 mg oral capsule once daily with morning meal for 6 weeks
16303729|NCT00620867|Other|placebo|matched placebo orally for 6 weeks
16303730|NCT00620854|Drug|Recombinant Salmon Calcitonin (rsCT)|Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
16303731|NCT00620854|Drug|Oral Tablet|0.15 mgs recombinant salmon calcitonin, single oral dose
16303732|NCT00620854|Drug|Oral Tablet|0.2mgs recombinant salmon calcitonin, single oral tablet
16303735|NCT00620828|Other|Placebo saline injection|20 cc of sterile, injectable saline
16303736|NCT00620828|Drug|Ropivicaine 0.5%|Ropivicaine
16303737|NCT00620815|Biological|MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine|Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.
16303738|NCT00620815|Biological|Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1|Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.
16303739|NCT00620815|Biological|Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine|Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.
16303740|NCT00620815|Biological|Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1|Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.
16303741|NCT00620815|Biological|Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine|Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
16303742|NCT00620815|Biological|MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine|Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
16303743|NCT00620802|Drug|CGT-2168|(CGT-2168, one capsule each daily)
16303744|NCT00620802|Drug|Plavix|(clopidogrel, 75 mg)
16303745|NCT00620789|Drug|Escitalopram + CBT-I|"Escitalopram, 10 mg daily for the duration of the study (6 months)
~CBT-I, four biweekly sessions during eight week Treatment phase."
16303746|NCT00620789|Behavioral|CBT-I plus placebo antidepressant medication|"CBT-I, 4 biweekly sessions, eight week Treatment phase.
~Placebo,daily for duration of study(6 months)."
16303747|NCT00620789|Drug|Escitalopram|"Escitalopram, 10 mg daily for the duration of the study (6 months)
~SH, four biweekly sessions during eight week Treatment phase"
16303748|NCT00620776|Behavioral|Cognitive Behavioral Therapy|This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.
16303749|NCT00620776|Drug|Venlafaxine XR|Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
16303750|NCT00620763|Other|High Meat - High Potential Renal Acid Load (PRAL) diet|Menu high in meat protein
16303751|NCT00620763|Other|Low Protein - Low Potential Renal Acid Load (PRAL) diet|Menu low in meat protein
16303752|NCT00620750|Drug|Extended release injectable naltrexone (Vivitrol)|Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.
16303753|NCT00620737|Biological|Autologous Human Fibroblasts (Isolagen TherapyTM)|"Collection of skin biopsy.
~Administration of 2 study injections
~Performance of various study assessments during clinic visits"
16303754|NCT00620737|Biological|Placebo|"Collection of skin biopsy.
~Administration of 2 study injections
~Performance of various study assessments during clinic visits"
16303755|NCT00620724|Drug|Placebo|Placebo three times daily
16303756|NCT00620724|Drug|Nifedipine|20 mg of slow-release Nifedipine three times daily
16303757|NCT00620711|Device|Olympic Cool Cap|Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
16303758|NCT00620685|Drug|Placebo|Tablet, once daily for 4 weeks
16303759|NCT00620685|Drug|PH-797804|Tablet, 1 mg PH-797804, once daily for 4 weeks
16303760|NCT00620685|Drug|PH-797804|Tablet, 5 mg PH-797804, once daily for 4 weeks
16303761|NCT00620672|Dietary Supplement|omega 3 fatty acids|The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.
16303762|NCT00620672|Dietary Supplement|vegetable oil|The supplement is a dietary supplement of vegetable oil as a placebo
16303763|NCT00620659|Drug|Comparator: MK0249|Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).
16303764|NCT00620659|Drug|Comparator: placebo|Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
16303765|NCT00620659|Drug|Comparator: modafinil|Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.
16303766|NCT00620646|Drug|aspirin, clopidogrel|aspirin 100 mg plus clopidogrel 150mg qd
16303767|NCT00620646|Drug|aspirin, clopidogrel, cilostazol|aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid
16303768|NCT00620633|Biological|WT1-sensitized T cells|Eligible patients who consent to enter this trial and for whom WT1 sensitized T cells have been generated in vitro, will receive a single dose of allogeneic WT1-sensitized T cells by bolus intravenous infusion. In this phase I trial, 6 dose levels of T cells will be evaluated, in sequential groups of 3 patients. Dose Escalation will be based on the incidence and severity of toxicities.
16303769|NCT00620620|Drug|Inhaled placebo|Inhaled Staccato Placebo
16303770|NCT00620620|Drug|Inhaled Zaleplon 0.5 mg|Inhaled Staccato Zaleplon 0.5 mg
16303771|NCT00620620|Drug|Inhaled Zaleplon 1 mg|Inhaled Staccato Zaleplon 1 mg
16303772|NCT00620620|Drug|Inhaled Zaleplon 2 mg|Inhaled Staccato Zaleplon 2 mg
16303773|NCT00620620|Drug|Inhaled Zaleplon 4 mg|Inhaled Staccato Zaleplon 4 mg
16303774|NCT00620607|Drug|huC242-DM4|dose of 126 mg/m2 or 168 mg/m2 given as IV once every 3 weeks
16303775|NCT00620594|Drug|BEZ235|
16303776|NCT00620581|Drug|Paroxetine|Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
16303777|NCT00620568|Drug|SLV-313 SR|sustained release tablets taken once daily for 14 days
16303778|NCT00620555|Drug|gabapentin|Orally administered gabapentin
16303779|NCT00620542|Drug|Rosuvastatin|capsule, oral, once daily
16303780|NCT00620542|Drug|Atorvastatin|capsule, oral, one daily
16303781|NCT00620529|Dietary Supplement|Ocean Nutrition 2050|1000mg capsules, 4 capsules/day for 8 weeks
16303782|NCT00620529|Dietary Supplement|Olive oil capsules|Olive oil capsules, 4 per day for 8 weeks
16303783|NCT00620503|Drug|Proellex 25 mg formulation A|One Proellex 25 mg formulation A capsule
16303784|NCT00620503|Drug|Proellex 25 mg formulation B|One 25 mg Proellex capsule formulation B administered both fed and fasted
16303785|NCT00620490|Drug|ropivacaine|Ropivacaine 0.5% 0.1 ml/kg per hour
16303786|NCT00620490|Other|nacl 0,9%|saline 0.9% 0.1 ml/kg per hour
16303787|NCT00620477|Drug|injection in the knee joint with 20 ml of chirocaine 0.125%|injection in the knee joint with 20 ml of chirocaine 0.125%
16303788|NCT00620477|Drug|injection in the knee joint with 20 ml of physiological fluid|injection in the knee joint with 20 ml of physiological fluid
16303789|NCT00620464|Drug|Radiopaque Implanon|Radiopaque rod for 3 years
16303790|NCT00620464|Drug|Implanon (etonogestrel implant)|Implanon (etonogestrel implant) for 3 years
16303791|NCT00620451|Drug|larazotide acetate|gelatin capsule
16303792|NCT00620451|Drug|placebo|gelatin capsule
16303793|NCT00620438|Drug|Lumefantrine-artemether and nevirapine|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive patients receiving nevirapine 200mg twice daily as part of their antiretroviral treatment
16303794|NCT00620438|Drug|lumefantrine-artemether and efavirenz|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to HIV positive adults receiving efavirenz tablets 600mg once daily
16303795|NCT00620438|Drug|Lumefantrine-artemether and rifampicin|Administration of lumefantrine 480mg co-formulated with artemether 80mg twice daily for three days to patients receiving rifampicin as part of fixed dose combination therapy for tuberculosis
16303796|NCT00620425|Drug|Sumatriptan|injection
16303797|NCT00620412|Dietary Supplement|Lactobacillus rhamnosus|2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10^10 LGG organisms.
16303798|NCT00620412|Dietary Supplement|placebo control|2 capsules by mouth twice a day for 28 days
16303799|NCT00620412|Biological|Influenza Virus Vaccine Live, Intranasal|intranasal spray, 0.1ml per nostril, one time dose
16303800|NCT00620399|Other|lumbar corset|
16303801|NCT00620386|Device|Bonfils|Endotracheal intubation using Bonfils Intubating Fiberscope
16303802|NCT00620386|Device|Macintosh|Endotracheal intubation using Macintosh laryngoscopy
16303803|NCT00620373|Device|Molecular Breast Imaging|Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
16303804|NCT00620373|Device|Conventional Mammography|Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
16303805|NCT00620373|Drug|Technetium (99mTc) sestamibi|Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
16303806|NCT00620360|Dietary Supplement|fructose|acute administration of 4 times 0.3g fructose/kg lean body mass
16303807|NCT00620360|Dietary Supplement|Fructose|acute administration of 4 times 0.3 g/kg fat-free mass oral fructose
16303808|NCT00620347|Drug|sunitinib|sunitinib (50mg/day, 4weeks on, 2 weeks off) Repeat every 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, or patients' refusal.
16303809|NCT00620321|Drug|LY2181308 sodium|750 milligrams (mg) is administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 (28 days) and Days 1, 8, 15, 22 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
16303810|NCT00620321|Drug|cytarabine|1.5 grams per square meter (g/m²) will be administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
16303811|NCT00620321|Drug|idarubicin|12 milligrams per square meter (mg/m²) will be administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and on Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
16303812|NCT00620308|Drug|CD-NP|One of two dosage levels (20 ng/kg/min and another level to be finalized) as a continuous intravenous infusion for four hours
16303813|NCT00620308|Drug|Placebo|Dextrose 5% in water (the vehicle)
16303814|NCT00620295|Drug|bortezomib|Bortezomib will be given 1 hour after gemcitabine by intravenous pyelogram (IVP) over 3 to 5 seconds followed by a standard saline flush or through a running intravenous (IV) line at the patient's assigned dose (1.0 up to 1.8 mg/m^2) on days 1 and 8 of a 21 day treatment cycle until disease progression or for a maximum of 6 cycles.
16303815|NCT00620295|Drug|gemcitabine hydrochloride|Gemcitabine will be administered as a 30 minute intravenous infusion at the patient's assigned dose (800 up to 1000 mg/m^2) on day 1 and day 8 of a 21 day cycle.
16303816|NCT00620282|Drug|liraglutide|Stepwise dose increase, s.c. (under the skin) injection, once daily
16303817|NCT00620282|Drug|placebo|Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
16303818|NCT00620282|Drug|glimepiride|Tablets, 1 - 4 mg daily
16303819|NCT00620269|Drug|Erlotinib|Erlotinib 150 mg p.o. daily x21 days every 3 weeks
16303820|NCT00620269|Drug|Induction or consolidation IP chemotherapy|Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles
16303821|NCT00620269|Drug|CCRT with IP chemotherapy (Irinotecan + Cisplatin)|Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 & 8 every 3 weeks X 2 cycles
16303822|NCT00620269|Radiation|CCRT|CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)
16303823|NCT00620256|Drug|AL-37807 ophthalmic suspension, 0.1%|
16303824|NCT00620256|Drug|Timolol gel forming solution, 0.5%|
16303825|NCT00620256|Other|AL-37807 ophthalmic solution vehicle|
16303826|NCT00620256|Drug|Latanoprost ophthalmic solution|
16303827|NCT00620243|Procedure|1: FDG PET|The study will evaluate the potential of PET imaging to identify early responders to chemotherapy. Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy. All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes. This will be correlated with response determined by changes in serum CA 125 levels.
16303828|NCT00620230|Drug|NVP-VAK694|
16303829|NCT00620230|Drug|NVP-VAK694|
16303830|NCT00620217|Genetic|intramyocardial injection of VEGF-A165/bFGF:placebo plasmid|The plasmid will be given at a total dose of 0.5 mg, 10 injections of 0,2 ml each into the region of reversible ischemia. The process of injecting the solution into each of ten points within the ischemic zone will take 20 to 40 seconds to minimize muscle disruption
16303831|NCT00620204|Drug|atorvastatin|atorvastatin 40mg qd for 1 year
16303832|NCT00620191|Drug|Metformin|Metformin 1000 mg twice a day titrated from 500 mg once a day
16303833|NCT00620191|Drug|Placebo|Placebo identical to metformin 2 tablets twice a day titrated from one table once a day
16303834|NCT00620178|Drug|Candesartan Cilexetil|oral once daily dose
16303835|NCT00620178|Drug|Losartan|once daily oral dose
16303836|NCT00620165|Drug|levetiracetam|Subjects will receive levetiracetam titrated up over 6 weeks to a maximum dose of 3000 milligrams (mg) per day, and then continue at 1500 mg twice daily for an additional 6 weeks.
16303837|NCT00620165|Drug|placebo|Subjects will receive identical placebo titrated up over 6 weeks to a maximum daily dose, and then continue twice daily for an additional 6 weeks.
16303838|NCT00620152|Behavioral|1|Low glycemic load diet by telephone counseling
16303839|NCT00620152|Behavioral|2|Low fat diet by telephone counseling
16303840|NCT00620139|Biological|the arachidonic acid and EGFR signaling pathways and their interaction in HNSCC tumorigenesis,|patient will undergo transoral pretreatment biopsy of the tumor. A comparable second tumor biopsy will be performed in the office after exactly 5 days of concurrent CRT (5 daily fractions of 180-200 cGy radiotherapy and a single cycle of Cisplatin or Carboplatin/5-FU based chemotherapy).Blood plasma and single-void urine specimens will be collected contemporaneously,before and after 5 days of concurrent CRT.
16303841|NCT00620126|Other|UC Home Automated Telemanagement|Weekly assessment with UC Home Automated Telemanagement
16303842|NCT00620126|Other|Best Available Care|Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA
16303843|NCT00620113|Drug|Odanacatib|Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
16303844|NCT00620113|Dietary Supplement|Vitamin D3|Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
16303845|NCT00620113|Dietary Supplement|Calcium carbonate|Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
16303846|NCT00620113|Drug|Placebo|Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
16303847|NCT00620100|Drug|Docetaxel|
16303848|NCT00620087|Procedure|Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
16303849|NCT00620087|Procedure|Screening Mammography|A screening mammogram is used to look for signs of breast cancer in women who don't have any breast symptoms or problems. X-ray pictures of each breast are taken from 2 different angles.
16303850|NCT00620074|Drug|voriconazole|Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).
16303851|NCT00620074|Drug|anidulafungin|Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy
16303852|NCT00620061|Drug|Lubiprostone 24|24 mcg capsules for oral administration
16303853|NCT00620048|Biological|Intramyocardial injection of autologous CD34-positive cells (stem cells)|Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.
16303854|NCT00620035|Drug|Radiopaque Etonogestrel Implant|One implant inserted for a 3-year treatment period
16303855|NCT00620022|Drug|Indacaterol 300 μg|Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16303856|NCT00620022|Drug|Placebo|Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
16303857|NCT00620009|Behavioral|Empathy Feedback|Discussion of empathy ratings between patients and therapists during psychotherapy sessions.
16303858|NCT00619996|Drug|Sorafenib (Nexavar)|"Sorafenib 400 mg bid orally continuously
~Sorafenib will be administered from the start of treatment in combination with Docetaxel until progression of disease."
16303859|NCT00619996|Drug|Docetaxel|Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.
16303860|NCT00619983|Drug|donepezil|Group 1: Will receive donepezil 5mg once a day
16303861|NCT00619983|Drug|duloxetine|Group 2: Will receive duloxetine 30 mg twice a day
16303862|NCT00619983|Drug|donepezil 2.5 mg and duloxetine 30mg|Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg
16303863|NCT00619983|Drug|placebo|Group 4: Will receive placebo pills
16303864|NCT00619983|Drug|gabapentin|Week 8: all subjects will have open label gabapentin added to their randomized study medication
16303865|NCT00619970|Procedure|Lactulose Breath Test|Healthy controls will receive one lactulose breath test to assess for SIBO
16303866|NCT00619970|Drug|xifaxan|xifaxan 550mg TID x10days
16303867|NCT00619970|Drug|placebo|placebo TID x 10days
16303906|NCT00619710|Drug|Imipenem-cilastatin|Intravenous
16303868|NCT00619970|Procedure|Lactulose Breath Test|Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo
16303869|NCT00619957|Drug|Placebo tablet|one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
16303870|NCT00619957|Drug|Risedronate|one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
16303871|NCT00619944|Drug|Lumefantrine - lopinavir/ritonavir drug interaction|Lumefantrine 480 mg co-formulated with artemether 80 mg administered as single dose to HIV-positive adults receiving lopinavir/ritonavir 400 mg/100 mg twice daily
16303872|NCT00619944|Drug|Lumefantrine only arm|Lumefantrine 480 mg co-formulated with artemether 80 mg administered as a single dose to antiretroviral naive HIV-positive patients
16303873|NCT00619931|Drug|APD791|APD791 or matching placebo in escalating doses
16303874|NCT00619918|Drug|Nebulized 3% saline|4 ml inhaled q8h
16303875|NCT00619918|Drug|Placebo|normal saline
16303876|NCT00619905|Drug|ACZ885|
16303877|NCT00619905|Drug|ACZ885|
16303878|NCT00619892|Drug|quetiapine XR|Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
16303879|NCT00619892|Drug|placebo|Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
16303880|NCT00619879|Drug|Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients|"Total Body Irradiation (TBI) 1200 cGy will be given on days -8,-7,-6 and -5 in eight sessions, delivering 150cGy in each session.
~Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
~Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3, -2."
16303881|NCT00619879|Drug|Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies|"Busulfan administration:
~For children >/= 4 years of age, Busulfan 0.8 mg/kg/dose will be given every 6 hours over days -8,-7, -6, and -5 for a total of 16 doses.
~For children < 4 years of age, Busulfan 1 mg/kg/dose will be given every 6 hours over days -8, -7, -6, -5 for a total of 16 doses.
~Pharmacokinetic analysis will guide dose modifications targeted to receive an average AUC of 800-1200 microMols*min for the 16 doses.
~Lorazepam (0.05 mg/kg) IV will be administered one half hour before the initial dose of Busulfan is given and every 6 hours through day -4.
~Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
~Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3 and -2."
16303882|NCT00619879|Other|Hematopoietic Progenitor Cell Transplantation (HPCT)|Hematopoietic progenitor cells (HPCs) will be infused on day 0. Source of cells may be bone marrow, peripheral blood cells, or cord blood units, from matched related or unrelated donors.
16303883|NCT00619879|Radiation|CNS radiation treatment for ALL with prior CNS disease patients|"Patients with prior CNS disease over the age of 1 year will be treated with 600 cGy of cranial irradiation in addition to 1200 cGy of TBI.
~Patients diagnosed with ALL with CNS disease (at the time of diagnosis or relapse) < 1 year of age will receive CNS treatment as Intrathecal Methotrexate as follows:
~Infants ≤ 1 year of age at the time of Intrathecal Therapy will receive a dosing of 7.5 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count
~Children 1-2 years of age at the time of Intrathecal Therapy will receive 8 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count"
16303884|NCT00619866|Drug|Elagolix|Elagolix tablets administered orally
16303885|NCT00619866|Drug|placebo|Placebo tablet administered orally
16303886|NCT00619853|Behavioral|treatment approach - CIMT|CIMT, 2 months, 2Hr per day
16303887|NCT00619853|Behavioral|treatment approach - HABIT|HABIT-2 months, 2Hr per day
16303888|NCT00619840|Drug|methylphenidate hydrochloride|sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
16303889|NCT00619840|Drug|Placebo|10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
16303890|NCT00619827|Drug|300 IR grass pollen allergen extract tablet|300 IR grass pollen allergen extract tablet once daily during four months
16303891|NCT00619827|Drug|Placebo tablet|Placebo tablet once daily during four months
16303892|NCT00619814|Procedure|Double-contrast Barium enema, colonoscopy|This is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed.
16303893|NCT00619801|Drug|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
16303894|NCT00619801|Drug|Placebo|Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
16303895|NCT00619788|Device|4.0-5.0mm AngioSculpt Scoring Balloon Catheter|The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.
16303896|NCT00619775|Device|PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device|Carotid artery stenting with distal embolic protection.
16303897|NCT00619762|Device|LTM - a porcine-based surgical mesh|Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy
16303898|NCT00619749|Dietary Supplement|juice rich in polyphenols|juice during 2 weeks
16303899|NCT00619749|Dietary Supplement|juice poor in polyphenols|juice during 2 weeks
16303900|NCT00619736|Drug|NSA-789|
16303901|NCT00619736|Other|Placebo|
16303902|NCT00619723|Drug|Citicoline|Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.
16303903|NCT00619723|Drug|Placebo|Inactive ingredient matching the active medication in appearance.
16303904|NCT00619723|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT.
16303905|NCT00619710|Drug|Meropenem|Intravenous
16303907|NCT00619697|Drug|biphasic insulin aspart|
16303908|NCT00619697|Drug|insulin glargine|
16303909|NCT00619697|Drug|metformin|
16303910|NCT00619697|Drug|glimepiride|
16303911|NCT00619684|Drug|lenalidomide|Given PO
16303912|NCT00619671|Drug|Rituximab (Rituxan)|Four weekly IV infusions of Rituxan with dosage individually calculated per subject.
16303913|NCT00619658|Other|telephone follow-up|subjects undergoing medical abortion will recieve a telephone call and be asked a series of clinical questions. Expulsion of the pregnancy will be assessed based on the answers to those questions.
16303914|NCT00619645|Drug|busulfan|
16303915|NCT00619645|Drug|cyclosporine|
16303916|NCT00619645|Drug|fludarabine phosphate|
16303917|NCT00619645|Drug|mycophenolate mofetil|
16303918|NCT00619645|Procedure|allogeneic hematopoietic stem cell transplantation|
16303919|NCT00619645|Procedure|peripheral blood stem cell transplantation|
16303920|NCT00619632|Behavioral|Lactation Consultant|Lactation consultant- primary care based, meets with women pre-natally, in the hospital, and at home up to 6 months post-partum.
16303921|NCT00619632|Behavioral|Provider Prompt|Prompt in electronic prenatal record will appear 5 times throughout pregnancy re: up to 10 open-ended discussion points for provider to raise
16303922|NCT00619632|Behavioral|LC+ Provider Prompt|Participants in this group receive both the LC and Provider Prompt interventions.
16303923|NCT00619619|Drug|Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)|DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.
16303924|NCT00619606|Device|TwinGuard|A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.
16303925|NCT00619606|Device|Standard endoscopic bite block|Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
16303926|NCT00619606|Device|Standard nasal cannula|Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.
16303927|NCT00619606|Device|CO2 sample line|Samples expired air from a patients nose. Tubing is connected to a capnograph.
16303928|NCT00619593|Other|Intensified diagnostic and treatment measures following 1st appropriate ICD therapy|"Assessment of general health status (weight, BP, NYHA)
~Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)
~Echocardiography (LVEF, LVEDD, mitral regurgitation)
~Non-invasive ischemia evaluation
~Coronary angiography (if indicated by ischemia evaluation)
~Upgrade to CRT, if indicated
~Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry)
~24 hrs ECG Holter (Heart rate variability)
~Further treatment (if applicable)
~Changes in ICD settings, or medication"
16303929|NCT00619593|Other|Standard follow-up|Standard follow-up in patients without appropriate ICD therapy
16303930|NCT00619567|Behavioral|Smartbrain|The initial session will be set for 10 minutes, with weekly increases (of 10 minutes) to a maximum of 30 minutes per day, 7 days a week. Each subject will be trained using the same modules of the Smartbrain protocol, with an emphasis on speed of information processing.
16303931|NCT00619541|Drug|Infusional 5-Fluorouracil|5-FU 3000 mg/sqm 48 hours continuous infusion every 14 days. 5-FU will be administered for a maximum of 12 cycles.
16303932|NCT00619541|Drug|Sorafenib (Bay 43-9006)|Sorafenib 400 mg bid orally continuously. Sorafenib will be administered from the start of treatment in combination with 5-FU until progression of disease.
16303933|NCT00619528|Biological|Infusion of Donor Hematopoietic Stem Cells and Campath-1H|Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.
16303934|NCT00619515|Other|questionnaire administration|Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).
16303935|NCT00619515|Procedure|implanted fiducial-based imaging|Undergo fiducial placement imaging
16303936|NCT00619515|Radiation|stereotactic radiosurgery|Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
16303937|NCT00619502|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, intramuscular (IM)
16303938|NCT00619489|Drug|vedolizumab|Vedolizumab for intravenous (IV) infusion
16303939|NCT00619476|Drug|GEn 1200mg/day|gabapentin enacarbil 1200mg/day
16303940|NCT00619476|Drug|GEn 2400mg/day|gabapentin enacarbil 2400mg/day
16303941|NCT00619476|Drug|GEn 3600mg/day|gabapentin enacarbil 3600mg/day
16303942|NCT00619476|Drug|Placebo|placebo
16303943|NCT00619463|Behavioral|Exercise|Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.
16303944|NCT00619463|Behavioral|Exercise|Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks
16303945|NCT00619450|Other|3D C-arm CT scan|The patient will be given an intravenous contrast dye and then hold their breath for 15 seconds while pictures are taken. The equipment used to take the pictures is like an arch that will rotate around the body. As the arch rotates, it will collect the pictures of the heart. These pictures will then be used to compute a three-dimensional image of the heart. The physicians will then continue with the planned procedure. The three-dimensional images will be reconstructed and available for the doctor to view during the case. The images will also be examined after the procedure by the physician.
16303946|NCT00619424|Drug|pazopanib|Oral tablet administered daily in dosages of 400 - 800 mg.
16303947|NCT00619424|Drug|erlotinib|oral tablet taken daily in dosages of 100-150 mg.
16303948|NCT00619424|Drug|pemetrexed|IV chemotherapeutic agent administered every 21 days in dosages of 400-500 mg/m2
16303949|NCT00619411|Behavioral|Interpersonal Therapy for Depressed Adolescents & Parents|15 weekly psychotherapy sessions
16303950|NCT00619398|Drug|Prograf|Oral
16303951|NCT00619398|Drug|FK506MR capsule|Oral
16303952|NCT00619385|Drug|Proellex|Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
16303953|NCT00619372|Drug|OKT3|0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
16303954|NCT00619372|Drug|OKT3, GC|0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
16303955|NCT00619372|Drug|OKT3|1 mg OKT3, PO (in the mouth) on day 1 through 5
16303956|NCT00619372|Drug|OKT3, GC|1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
16303957|NCT00619372|Drug|OKT3|5 mg OKT3, PO (in the mouth) on day 1 through 5
16303958|NCT00619372|Drug|GC|7.5 mg GC, PO (in the mouth) on day 1 through 5
16303959|NCT00619359|Drug|Comparator: fosaprepitant dimeglumine|single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
16303960|NCT00619359|Drug|Comparator: Aprepitant|Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
16303961|NCT00619359|Drug|Dexamethasone|Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
16303962|NCT00619359|Drug|Dexamethasone|Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
16303963|NCT00619359|Drug|Ondansetron|single IV dose of 32 mg of ondansetron on Day 1.
16303964|NCT00619346|Drug|Placebo|Placebo tablets, BID X 14 days
16303965|NCT00619346|Drug|pafuramidine maleate|Pafuramidine maleate, 100 mg tablet BID X 14 days
16303966|NCT00619333|Drug|follitropin and lutropin|follitropin and lutropin
16303967|NCT00619320|Behavioral|Safer Sex Skills Building (SSB)|Test the effectiveness of an intervention for reducing sexual risk factors for HIV infection in two samples of pregnant drug-using women. The intervention, Safer Sex Skills Building (SSB)(El Bassel and Schilling (1991, 1992)), is a manual-driven, gender-specific group intervention delivered by mental health counselors. To date, its effectiveness has not been examined in pregnant, drug using women. The proposed study will examine the effectiveness of the intervention in both drug treatment (RBHA, N = 200) and prenatal care (PCC, N = 200) settings. Using a randomized clinical trial design, the study will compare the five-session SSB group intervention to a one-session standard group HIV Education session (ED). Study hypotheses: that women in the SSB intervention will have better outcomes (e.g., fewer unprotected penetrative sexual behaviors) than women in the control group (ED).
16303968|NCT00619307|Drug|Rebif New Formulation + prophylactic Ibuprofen|Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected
16303969|NCT00619307|Drug|Rebif New Formulation + ibuprofen PRN|Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.
16303970|NCT00619268|Drug|Temsirolimus|25 mg once per week administered intravenously
16303971|NCT00619268|Drug|Bevacizumab|10 mg/kg * 1 time /2 weeks administered intravenously
16303972|NCT00619268|Drug|Sunitinib|50 mg administered orally once daily in 6 weeks cycles :4 weeks of treatment followed by 2 weeks off
16303973|NCT00619268|Drug|Interferon alpha-2a|Administered subcutaneously as 9 MU three times per week
16303974|NCT00619255|Behavioral|Adolescent Trauma Support Program|The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.
16303975|NCT00619242|Drug|sorafenib|2 tablets with water by mouth twice a day for two weeks.
16303976|NCT00619229|Drug|Alprostadil (prostaglandin E1)|Alprostadil 20 µg ampoules; 60 µg alprostadil/d i.v. for 15 days.
16303977|NCT00619229|Other|Placebo|Placebo/d i.v. for 15 days
16303978|NCT00619216|Drug|Mycophenolic Acid (Myfortic)|Equimolar conversion from mycophenolate mofetil to mycophenolic acid
16303979|NCT00619203|Drug|Glycerol and paracetamol|"glycerol by mouth (po) 1.5ml/kg max 25 ml/dose x 6 hourly x 8 doses
~paracetamol PR 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7"
16303980|NCT00619203|Drug|Paracetamol|paracetamol 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses
16303981|NCT00619203|Drug|Paracetamol|paracetamol po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
16303982|NCT00619203|Drug|Paracetamol|po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
16303983|NCT00619203|Drug|Placebo|2 placebos, one po, one suppository
16303984|NCT00619203|Drug|Paracetamol and glycerol|"35 mg/kg po first dose, then 20 mg/kg 6 hourly x 7 paracetamol
~1.5 ml/kg max 25 ml/dose 6 hourly x 8 doses"
16303985|NCT00619203|Drug|Glycerol|glycerol 1.5 ml/kg /dose 6 hourly x 8 max dose = 25ml
16303986|NCT00619190|Drug|aripiprazole|aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
16303987|NCT00619164|Drug|E5555|E5555, 50 mg (tablet), taken orally, once a day.
16303988|NCT00619164|Drug|E5555|E5555, 100 mg (tablet), taken orally, once a day.
16303989|NCT00619164|Drug|E5555|E5555, 200 mg (tablet), taken orally, once a day.
16303990|NCT00619164|Drug|Placebo|Placebo tablet taken orally, once a day.
16303991|NCT00619151|Device|Top Hat|Implant of CarboMedics Top Hat mechanical valve.
16303992|NCT00619151|Device|Regent|Implant of the St. Jude Medical Regent mechanical valve
16303993|NCT00619138|Behavioral|individual cognitive-behavioural therapy|1 session per week for 12 weeks
16303994|NCT00619138|Behavioral|stepped care model|three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy
16303995|NCT00619125|Other|palm pilot recording responses to questionnaires|Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
16303996|NCT00619112|Drug|temozolomide|single arm study
16304102|NCT00618488|Dietary Supplement|Placebo|Placebo administered once a day for 6 weeks
16303997|NCT00619099|Drug|decitabine|Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
16303998|NCT00619099|Drug|decitabine|Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
16303999|NCT00619086|Drug|Dexamethason Helvepharm ®|8 mg Dexamethason i.v. 45 minutes prior to surgery
16304000|NCT00619086|Drug|Placebo|100 ml sodium chloride i.v. 45 minutes prior to surgery
16304001|NCT00619073|Drug|clopidogrel + aspirin|Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days.
16304002|NCT00619073|Drug|placebo|Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days.
16304003|NCT00619073|Drug|Aspirin|Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.
16304004|NCT00619060|Drug|Topical Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks.
16304005|NCT00619060|Drug|Placebo|Participants apply topical placebo to one forearm once daily for 4 weeks.
16304006|NCT00619034|Drug|Latanoprost, diclofenac and dorzolamide (eyedrops)|1 eyedrop twice daily in one week
16304007|NCT00619034|Drug|Diclofenac|dicolfenac eyedrops twice daily i one eye
16304008|NCT00619034|Drug|Dorzolamide|dorzolamide eyedrops twice daily, in one eye for one week
16304009|NCT00619021|Drug|gemcitabine hydrochloride|4 dose levels designated by cohort; 600 mg/m^2, 800 mg/m^2, 1000 mg/m^2, 1200 mg/m^2
16304010|NCT00619008|Other|Ad libitum low carbohydrate diet|6 week ad libitum low carbohydrate diet
16304011|NCT00619008|Other|Ad libitum High Complex Carbohydrate Diet|6 week ad libitum high complex carbohydrate diet
16304012|NCT00619008|Other|Energy-restricted high complex carbohydrate diet|6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.
16304013|NCT00618995|Drug|Comparator: ER niacin (+) laropiprant|ER niacin 2 g/ laropiprant 40 mg daily for 7 days.
16304014|NCT00618995|Drug|Comparator: ER niacin|ER niacin 2 g daily for 7 days.
16304015|NCT00618995|Drug|Comparator: laropiprant|laropiprant 40 mg daily for 7 days.
16304016|NCT00618995|Drug|Comparator: placebo|matching placebo tablets for each of the interventions once daily for 7 days
16304017|NCT00618982|Drug|Sorafenib (Nexavar, BAY43-9006)|The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.
16304018|NCT00618969|Other|haploidentical allogeneic PBSC transp|"Days -5 and -4: IV busulfan 3.2 mg/kg/dose daily for 2 days
~Day -3: IV melphalan 100 mg/m2 as a single dose
~Days -2 and -1: IV alemtuzumab 30 mg/dose daily for 2 days
~Day 0: Transplantation of haploidentical related allogeneic peripheral blood stem cells (PBSCs)- target cell dose 10 x 106 donor CD34+ cells per kilogram of recipient weight"
16304019|NCT00618956|Drug|Milnacipran hydrochloride|Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily [BID]), oral administration.
16304020|NCT00618956|Drug|Placebo|Placebo
16304021|NCT00618943|Behavioral|Tobacco Use Cessation|The proposed intervention will proceed in three steps. Step 1, provided to all intervention participants, includes multimedia, stage-based, expert-system contacts at intake, 3- and 6-months follow-up supported with brief (15-min) motivational counseling sessions. Step 2, reserved for intervention participants interested in quitting, consists of 12-weeks of individual CBT sessions for smoking cessation. Step 3, a 12-week course of nicotine patch, will be offered to adolescents who enter the CBT Cessation Treatment, who do not have any medical contraindications, and who smoke an average of 5 cigarettes or more per day in the past month.
16304022|NCT00618930|Drug|Moviprep®|use of Moviprep®
16304023|NCT00618930|Drug|Fleet|Use of Fleet
16304024|NCT00618917|Genetic|Manganese Superoxide Dismutase Plasmid Liposome|15 ml of liquid that contains either 0.3 mg, 3.0 mg or 30.0 mg (depending on which cohort is open when the subject is entered) of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses.
16304025|NCT00618917|Drug|carboplatin|Chemotherapy to stop the growth of tumor cells.
16304026|NCT00618917|Drug|paclitaxel|Chemotherapy to stop the growth of tumor cells. This drug kills tumor cells by inducing multipolar divisions. Cells entering mitosis in the presence of concentrations of paclitaxel equivalent to those in human breast tumors form abnormal spindles that contain additional spindle poles.
16304027|NCT00618904|Dietary Supplement|Probiotics - Lactobacillus and bifidobacterium|Probiotics administered bid for 6 weeks.
16304028|NCT00618904|Dietary Supplement|Placebo|Placebo administered bid for 6 weeks.
16304029|NCT00618878|Procedure|Electroacupuncture|twice a week for 26 treatments in total
16304030|NCT00618878|Procedure|Laser Therapy|twice a week for a total of 26 treatments
16304031|NCT00618865|Dietary Supplement|Omega-3 fatty acids|
16304032|NCT00618852|Drug|Furosemide|The dose of furosemide will be 1 mg/kg by intravenous bolus injection
16304033|NCT00618852|Drug|Saline|1 mg/kg by intravenous bolus injection
16304034|NCT00618839|Biological|StrataGraft Skin Tissue|StrataGraft™ skin tissue is provided as a suturable circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells).
16304035|NCT00618839|Procedure|Cadaver allograft|The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.
16304036|NCT00618826|Drug|Paclitaxel|Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
16304037|NCT00618826|Drug|Gemcitabine|Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
16304103|NCT00618475|Behavioral|Cognitive behavioral therapy|"10 sessions
~1 hour per week"
16304251|NCT00617513|Drug|Prucalopride|2 mg o.d.
16304397|NCT00616590|Procedure|quality-of-life assessment|
16304038|NCT00618826|Drug|Avastin|10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
16304039|NCT00618813|Other|radiation therapy|Undergo radiation therapy
16304040|NCT00618813|Other|therapeutic conventional surgery|Undergo surgery
16304041|NCT00618813|Drug|etoposide|Given IV
16304042|NCT00618813|Drug|ifosfamide|Given IV
16304043|NCT00618813|Drug|doxorubicin hydrochloride|Given IV
16304044|NCT00618813|Drug|cyclophosphamide|Given IV
16304045|NCT00618813|Drug|vincristine sulfate|Given IV
16304046|NCT00618813|Drug|topotecan hydrochloride|Given IV
16304047|NCT00618813|Biological|filgrastim|Given SC
16304048|NCT00618800|Behavioral|Pharmaceutical Care|Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen. The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.
16304049|NCT00618800|Other|Written Materials|Participants receive written information about falls prevention.
16304050|NCT00618787|Device|COPA AMD (note: name is not an acronym)|Foam dressing impregnated with Polyhexamethylene Biguanide
16304051|NCT00618787|Device|COPA (note: name is not an acronym)|Regular foam dressing without PHMB
16304052|NCT00618774|Drug|telmisartan40/amlodipine5|
16304053|NCT00618774|Drug|telmisartan80/amlodipine5|
16304054|NCT00618761|Other|hyperglycemic clamp test|hyperglycemic clamp test
16304055|NCT00618748|Drug|Olanzapine|5-20 mg/day, oral, daily
16304056|NCT00618735|Drug|BIIB021|Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
16304057|NCT00618735|Drug|BIIB021|Twice daily dosing
16304058|NCT00618722|Drug|Deoxycholic Acid Injection|
16304059|NCT00618722|Drug|Placebo|
16304060|NCT00618709|Drug|ATX-101|ATX-101 single dose
16304061|NCT00618696|Biological|anti-CD45 monoclonal antibody AHN-12|150 mg/m^2 cold antibody at Day 0
16304062|NCT00618696|Radiation|yttrium Y 90 anti-CD45 monoclonal antibody AHN-12|Dose per scheduled level; 2.5-12.5 mCi/m^2
16304063|NCT00618683|Procedure|Cardiac Invasive Electrophysiological Study|Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study
16304064|NCT00618670|Behavioral|Walking Exercise|Three times per week for 3 months
16304065|NCT00618670|Behavioral|Control--Resistance Training|Three times per week for 3 months
16304066|NCT00618657|Drug|Carboplatin|Given IV
16304067|NCT00618657|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16304068|NCT00618657|Drug|bevacizumab|Given IV
16304069|NCT00618657|Drug|trastuzumab|Given IV
16304070|NCT00618657|Procedure|magnetic resonance imaging|Optional correlative studies
16304071|NCT00618657|Procedure|therapeutic conventional surgery|Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts
16304072|NCT00618644|Drug|Ranibizumab|Ranibizumab 0.5 mg intravitreal injection
16304073|NCT00618631|Drug|Nicotine|
16304074|NCT00618631|Drug|Carfentanil|
16304075|NCT00618618|Drug|Deoxycholic Acid Injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16304076|NCT00618618|Drug|Placebo|
16304077|NCT00618605|Biological|Ad26.ENVA.01 HIV-1 vaccine|Recombinant adenovirus serotype 26 HIV-1 vaccine
16304078|NCT00618592|Dietary Supplement|PreOp carbohydrate drink|800 mL of PreOp evening before surgery, 400 mL at least two hours before surgery
16304079|NCT00618579|Drug|LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects|Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
16304080|NCT00618566|Behavioral|WPD and Depression Treatment Group|Intervention selected will depend on Phase I data analysis.
16304081|NCT00618553|Other|Questionnaire|Questionnaire regarding quality-of-life that lasts about 30 minutes.
16304082|NCT00618553|Behavioral|Pulmonary Rehabilitation|Rehabilitation treatment given over about 3-4 weeks.
16304083|NCT00618540|Biological|alemtuzumab|Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.
16304084|NCT00618540|Drug|fludarabine phosphate|Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3. (dose adjust if age <12 months)
16304085|NCT00618540|Drug|melphalan|Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)
16304086|NCT00618540|Procedure|stem cell transplantation|Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation
16304087|NCT00618527|Drug|mycophenolate mofetil (Cellcept)|1 gram po, bid
16304088|NCT00618527|Drug|human interferon beta 1a (Rebif)|44mcg sq injection every other day
16304089|NCT00618514|Device|Bright Tip Laser Fiber|Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber with a fitted ceramic tip on the end. Treatment performed on one leg.
16304090|NCT00618514|Device|Bare Tip Laser Fiber|Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber readily available on the market with a bare tip on the end. Treatment performed on one leg.
16304091|NCT00618501|Drug|cytarabine|
16304092|NCT00618501|Drug|daunorubicin hydrochloride|
16304093|NCT00618501|Drug|etoposide|
16304094|NCT00618501|Drug|imatinib mesylate|
16304095|NCT00618501|Drug|leucovorin calcium|
16304096|NCT00618501|Drug|methotrexate|
16304097|NCT00618501|Drug|prednisolone|
16304098|NCT00618501|Drug|therapeutic hydrocortisone|
16304099|NCT00618501|Drug|vincristine sulfate|
16304100|NCT00618501|Procedure|allogeneic hematopoietic stem cell transplantation|
16304101|NCT00618488|Dietary Supplement|Probiotic BB12 - Bifidobacterium lactis|Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks
16304104|NCT00618462|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include weekly 50-minute sessions for 8 weeks. The sessions will focus on learning skills to cope with urges to gamble and developing alternatives to gambling.
16304105|NCT00618462|Behavioral|Contingency management (CM)|CM will provide incentive, such as a gift certificate to a store or restaurant, for completing activities not related to gambling. Participants and their therapists will decide upon two potential alternative activities to gambling during each therapy session.
16304106|NCT00618462|Behavioral|Psychoeducation therapy|Psychoeducation therapy will include weekly 50-minute therapy sessions for 8 weeks. The sessions will focus on education about gambling and related problems.
16304107|NCT00618462|Behavioral|Case management|Case management will assist participants in obtaining additional services from the community as needed.
16304108|NCT00618462|Behavioral|Gamblers Anonymous (GA)|All participants will be referred to GA, a support group of people who are recovering from gambling addiction, and will be encouraged to attend meetings.
16304109|NCT00618449|Drug|Azithromcyin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 & Day 30 for a total of 2 doses.
16304110|NCT00618449|Drug|Azithromycin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given at Day 30 for a total of 1 dose.
16304111|NCT00618436|Drug|Levetiracetam|Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days.
16304112|NCT00618436|Drug|Phenytoin|The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.
16304113|NCT00618423|Drug|Placebo|50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
16304114|NCT00618423|Drug|Ketamine|50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
16304115|NCT00618410|Device|Carbon dioxide, USP|Carbon dioxide (CO2) delivered via a nosepiece at a flow rate of 0.5 (± 0.05) SLPM for 10 seconds /nostril
16304116|NCT00618410|Other|Placebo|Nasal placebo
16304117|NCT00618397|Drug|Ketamine|Ketamine administered in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr to PICU patients.
16304118|NCT00618384|Drug|Sorafenib|patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
16304119|NCT00618371|Drug|Raltegravir (MK-0518)|Antiretroviral drug intensification with Raltegravir (MK0518) 400mg orally every 12 hours for 28 days in addition to the prescribed antiretroviral therapy
16304120|NCT00618358|Device|Vascular Sealant System|The Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
16304121|NCT00618358|Other|Gelfoam/Thrombin|
16304122|NCT00618345|Drug|everolimus|
16304123|NCT00618345|Genetic|DNA analysis|
16304124|NCT00618345|Genetic|protein analysis|
16304125|NCT00618345|Genetic|western blotting|
16304126|NCT00618345|Other|flow cytometry|
16304127|NCT00618345|Other|laboratory biomarker analysis|
16304128|NCT00618345|Procedure|biopsy|
16304129|NCT00618332|Drug|mometasone furoate nasal spray|2 puffs in each nostril once a day for 2 weeks
16304130|NCT00618332|Drug|placebo|2 puffs in each nostril once a day for 2 weeks
16304131|NCT00618319|Drug|BIIB021|Dose, schedule, and duration specified in protocol
16304132|NCT00618293|Drug|Haemate HS|intravenous infusion of Haemate (dosage dependent on body weight)
16304133|NCT00618293|Other|NaCl-solution|intravenous infusion of 0.9%NaCl-Solution
16304134|NCT00618280|Drug|nicotine nasal spray|0,5 mg nicotine nasal spray or placebo (pepperspray)
16304135|NCT00618254|Drug|Granisetron|
16304136|NCT00618241|Drug|lamotrigine|100 mg
16304137|NCT00618241|Drug|Raltegravir|400 mg BD
16304138|NCT00618228|Drug|Balsalazide|
16304139|NCT00618215|Behavioral|peer group educational implementation strategy|"Delivery CPG
~Education session IQual group
~Online training website (individual feed back)
~Reminder (flow chart), individual feed back record form
~Feed back by email
~Registration in practice"
16304140|NCT00618202|Drug|Balsalazide|
16304141|NCT00618176|Drug|Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)|Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid
16304142|NCT00618176|Drug|Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)|Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid
16304143|NCT00618176|Drug|Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)|Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid
16304144|NCT00618163|Drug|Meloxicam|
16304145|NCT00618150|Behavioral|Patient education|An educational program: Three lessons spaced over 2 weeks.
16304146|NCT00618124|Drug|SU011248; Capecitabine|Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.
16304147|NCT00618111|Drug|Granisetron|
16304192|NCT00617799|Other|flow cytometry|
16304148|NCT00618098|Biological|Octaplex (human prothrombin complex concentrate)|INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.).
16304149|NCT00618098|Biological|Fresh frozen plasma|INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice.
16304150|NCT00618085|Behavioral|Motor imagery practice|During motor imagery practice a person imagines performing a skill or movement with all its sensory consequences without actually moving. In this study the therapists follow a motor imagery guideline designed for rehabilitation of skills and movement performance in subjects with neurological disease or damage. The guideline offers therapists structure and a strategy to deliver subject-specific imagery. The guideline is based on three major frameworks, namely; principles of motor learning, phased process of human movement and a training guide for sports coaches and performers from the National Coaching Foundation.
16304151|NCT00618085|Other|Standard physiotherapy and occupational therapy|Patients with neurological disease or damage will receive standard physiotherapy and occupational therapy.
16304152|NCT00618072|Drug|metformin and rosiglitazone|4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
16304153|NCT00618059|Drug|Pilocarpine|
16304154|NCT00618046|Drug|Oxcarbazepine|
16304155|NCT00618033|Procedure|Hemodialysis|varying concentration of glucose in dialysate
16304156|NCT00618020|Device|CiTop(tm) Guidewire|CiTop(tm)6 Guidewire
16304157|NCT00618007|Drug|PF-00734200 30 mg QD|30 mg QD
16304158|NCT00618007|Drug|PF-00734200 20 mg QD|20 mg QD
16304159|NCT00618007|Drug|Placebo|Placebo
16304160|NCT00617994|Drug|Ruxolitinib|Ruxolitinib 1.5% cream BID for 28 days
16304161|NCT00617981|Drug|ThermoDox|Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
16304162|NCT00617981|Drug|5% Dextrose Solution|Single 30 minute intravenous infusion
16304163|NCT00617968|Drug|DOCETAXEL|
16304164|NCT00617955|Drug|Aprotinin|compare outcomes of Aprotinin versus Amicar
16304165|NCT00617955|Drug|Amicar|compare outcomes of Aprotinin versus Amicar
16304166|NCT00617942|Drug|Cohort 1 neo-adjuvant|"Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
16304167|NCT00617942|Drug|Cohort 2 neo-adjuvant|Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
16304168|NCT00617942|Drug|Cohort 1 adjuvant|Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
16304169|NCT00617942|Drug|Cohort 2 adjuvant|Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
16304170|NCT00617929|Biological|anti-thymocyte globulin|administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
16304171|NCT00617929|Biological|rituximab|administered 375 mg/m^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
16304172|NCT00617929|Drug|clofarabine|administered 30 mg/m^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
16304173|NCT00617929|Procedure|stem cell transplantation|administered on Day 0 per institutional guidelines.
16304174|NCT00617903|Drug|Azelaic acid|15% foam to be applied topically twice daily
16304175|NCT00617903|Drug|Vehicle foam|Active-ingredient-free vehicle to be applied topically twice daily
16304176|NCT00617890|Biological|robatumumab|Robatumumab IV every two weeks until disease progression.
16304177|NCT00617877|Drug|losartan potassium|Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day (in case of BP more than 140/90 mm Hg.) Continued until the end of the study (visit 9-week 48).
16304178|NCT00617877|Drug|Comparator: Hydrochlorothiazide|Hydrochlorothiazide 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).
16304179|NCT00617864|Drug|Human Albumin Infusion|Group will receive single infusion of albumin at the time of oocyte retrieval.
16304180|NCT00617864|Drug|Saline Infusion|Group will receive single infusion of saline at the time of oocyte retrieval.
16304181|NCT00617851|Biological|Lot A of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
16304182|NCT00617851|Biological|Lot B of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
16304183|NCT00617851|Biological|Lot C of Influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
16304184|NCT00617851|Biological|Comparator influenza virus vaccine|1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
16304185|NCT00617851|Biological|All 3 consecutive lots of influenza virus vaccine pooled|1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
16304186|NCT00617838|Other|Optimal gluten introduction|Optimization of gluten introduction by nutritional counselling
16304187|NCT00617825|Other|cyrotherapy as a cool gel wrap|A cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study
16304188|NCT00617812|Biological|Shan5|Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
16304189|NCT00617799|Biological|aldesleukin|
16304190|NCT00617799|Genetic|gene expression analysis|
16304191|NCT00617799|Genetic|mutation analysis|
16304193|NCT00617786|Procedure|Current Perception Threshold (CPT) Testing|During the CPT testing a catheter will be placed in the bladder. The catheter has sensors to record the body's sensation of pressure. The sensation felt will be similar to a light touch and is painless. A gel pad will be placed in the general area of the vagina to record the feeling of a light touch.
16304194|NCT00617773|Biological|hu3S193|20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
16304195|NCT00617760|Biological|Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)|MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle
16304196|NCT00617760|Biological|7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)|PCV7 (0.5 ml) to be administered in the right thigh muscle
16304197|NCT00617760|Biological|Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)|MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
16304198|NCT00617747|Drug|Zolmitriptan|5mg Nasal Spray
16304199|NCT00617747|Drug|Placebo|
16304200|NCT00617734|Biological|IMC-A12 (cixutumumab)|IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops.
16304201|NCT00617734|Biological|cetuximab (Erbitux ®)|IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops.
16304202|NCT00617721|Other|Blood withdrawal|Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
16304203|NCT00617708|Biological|cixutumumab|Given IV
16304204|NCT00617708|Drug|erlotinib hydrochloride|Given PO
16304205|NCT00617708|Drug|gemcitabine hydrochloride|Given IV
16304206|NCT00617695|Drug|Zolmitriptan|5mg nasal spray
16304207|NCT00617695|Drug|Placebo|
16304208|NCT00617682|Biological|PNCRM9|0.5 mL IM at 30-35 wks gestation
16304209|NCT00617682|Biological|Placebo comparator|Sucrose cake (NaCl and sucrose) in aluminum phosphate adjuvant diluent at 0.5 mg per 0.5 mL dose IM at 30-35 wks gestation
16304210|NCT00617669|Drug|Docetaxel|intravenous infusion given every three weeks
16304211|NCT00617669|Drug|ZD4054|10 mg oral once daily dose
16304212|NCT00617669|Drug|Placebo|placebo oral tablet once daily
16304213|NCT00617656|Drug|Cisplatin, Docetaxel|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
16304214|NCT00617656|Drug|Gemcitabine, Cisplatin|Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
16304215|NCT00617656|Drug|Docetaxel, Cisplatin|Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
16304216|NCT00617656|Drug|Docetaxel|Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
16304217|NCT00617643|Drug|Nevirapine without dose escalation|Fixed dose combination tablets of stavudine 30mg,lamivudine 150mg and nevirapine tablets 200mg twice daily at initiation of antiretroviral therapy in patients receiving rifampicin for tuberculosis therapy
16304218|NCT00617643|Drug|Nevirapine initiation with dose escalation|Triomune® 30 (according to body weight) one tablet once daily (am) plus Zerit® 30 + Epivir 150mg once daily (pm) for two weeks
16304219|NCT00617617|Dietary Supplement|Prevastein HC®|Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.
16304220|NCT00617617|Other|Placebo|Control Group - Control Group participants will receive an identical placebo.
16304221|NCT00617604|Drug|Alefacept|IV and subcutaneous injection
16304222|NCT00617604|Drug|placebo|IV and subcutaneous injection
16304223|NCT00617604|Drug|Tacrolimus|The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
16304224|NCT00617604|Drug|Mycophenolate Mofetil|Mycophenolic mofetil was administered as 750 mg twice per day orally
16304225|NCT00617604|Drug|Steroids|"Methylprednisolone or equivalent:
~Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
~Prednisone or equivalent:
~Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally"
16304226|NCT00617591|Drug|Lenalidomide|25 mg orally on days 1-21
16304227|NCT00617591|Drug|Pegylated Liposomal Doxorubicin (PLD)|40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated)
16304228|NCT00617591|Drug|Dexamethasone|40 mg orally on days on 1-4
16304229|NCT00617578|Device|ATP One Shot ON|"The new antitachycardia pacing algorithm ATP One Shot attempts to terminate fast VT by one ATP sequence and thus avoid defibrillation shock delivery"
16304230|NCT00617578|Device|ATP One Shot OFF|Standard defibrillation shock delivery
16304231|NCT00617565|Drug|biphasic insulin aspart|
16304232|NCT00617565|Drug|biphasic human insulin|
16304233|NCT00617552|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
16304234|NCT00617552|Drug|TZP-101|20 micrograms/kg IV 2ml/minute for 30 minutes
16304235|NCT00617552|Drug|TZP-101|40 micrograms/kg IV 2 ml/minute for 30 minutes
16304236|NCT00617552|Drug|TZP-101|80 micrograms/kg IV 2ml/minute for 30 minutes
16304237|NCT00617552|Drug|TZP-101|160 micrograms/kg IV 2ml/minute over 30 minutes
16304238|NCT00617552|Drug|TZP-101|320 micrograms/kg IV 2ml/minute for 30 minutes
16304239|NCT00617552|Drug|TZP-101|480 micrograms/kg IV 2ml/minute over 30 minutes
16304240|NCT00617552|Drug|TZP-101|600 micrograms/kg IV 2ml/minute for 30 minutes
16304241|NCT00617539|Drug|irinotecan hydrochloride|
16304242|NCT00617539|Drug|temozolomide|
16304243|NCT00617526|Drug|RDEA806 400 mg|
16304244|NCT00617526|Drug|Placebo|Placebo
16304245|NCT00617526|Drug|RDEA806 1000 mg|
16304246|NCT00617526|Drug|RDEA806 600 mg|
16304247|NCT00617526|Drug|RDEA806 800 mg|
16304248|NCT00617513|Drug|Prucalopride|0.5 mg once daily
16304249|NCT00617513|Other|Placebo|o.d.
16304250|NCT00617513|Drug|Prucalopride|1 mg o.d.
16304252|NCT00617500|Other|flower therapy|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
16304253|NCT00617500|Other|therapeutic touch|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
16304254|NCT00617500|Other|auricular therapy|Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
16304255|NCT00617500|Drug|Hormones|Estradiol 1 mg and a drospirenone 2mg/day (3 months)
16304256|NCT00617474|Drug|Erythropoietin|sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.
16304257|NCT00617474|Drug|Placebo|placebo
16304258|NCT00617461|Drug|GEn 1200mg/day|1200mg/day gabapentin enacarbil
16304259|NCT00617461|Drug|GEn 3600mg/day|3600mg/day gabapentin enacarbil
16304260|NCT00617448|Procedure|diathermy haemorrhoidectomy under espinal anesthesia|For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
16304261|NCT00617448|Procedure|diathermy haemorrhoidectomy under local anesthesia|For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan). For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
16304262|NCT00617448|Procedure|Ligasure haemorrhoidetomy under spinal anestesia|For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
16304263|NCT00617448|Procedure|Ligasure haemorrhoidectomy under local anesthesia|For surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
16304264|NCT00617435|Dietary Supplement|vaccenic acid enriched diet|"The experimental milk fat, entitled vaccenic acid enriched milk fat (VAMF), has been obtained by feeding cows with a diet containing sunflower oil."
16304265|NCT00617435|Dietary Supplement|Elaidic acid enriched diet|Mixture of vegetable oils (including partially hydrogenated oils)
16304266|NCT00617435|Dietary Supplement|control diet|Mixed of different oil
16304267|NCT00617409|Drug|Paclitaxel|All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads. At any point when a patient develops evidence of progressive disease, the patient will be treated with second-line chemotherapy. Paclitaxel will be given at a dose of 200 mg/m² on day 1 of 21 day cycles.
16304268|NCT00617409|Biological|Drug: Ad.p53-DC vaccines|Patients randomized to Arm B will receive vaccinations on 3 occasions, at 2 week intervals. 1-5x106 p53 positive DCs in 1 ml will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2-3 weeks after vaccine # 3 (first vaccine course). If patients show no sign of disease progression at restaging, then a second leukopheresis will be performed. Patients will then be vaccinated 3 more times (second vaccine course) at 4-week intervals, for a total of 6 possible vaccines. Restaging will occur 2-4 weeks after completing the second vaccine course. Patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
16304269|NCT00617409|Drug|All -trans Retinoic Acid (ATRA)|The patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
16304270|NCT00617396|Drug|Quetiapine (50 mg/day-100mg/day)|Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
16304271|NCT00617370|Drug|epirubicin, cyclophosphamide, Paclitaxel,|EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). Paclitaxel (175 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg).
16304272|NCT00617357|Device|LTM (Strattice Reconstructive Tissue Matrix)|Surgical mesh
16304273|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine , 5555 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
16304274|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine , 5553 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
16304275|NCT00617344|Biological|Tetravalent CYD Dengue Vaccine, 4444 formulation|A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
16304276|NCT00617331|Biological|Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine|Inactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms.
16304277|NCT00617318|Dietary Supplement|Pomegranate|"All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks."
16304278|NCT00617318|Dietary Supplement|Placebo|"All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks."
16304279|NCT00617305|Drug|Ambrisentan|Ambrisentan was administered orally once daily; dose level was 5 mg for the first 4 weeks, followed by 10 mg for the remainder of the study; ambrisentan was supplied as 5-mg and 10-mg tablets.
16304280|NCT00617305|Drug|Placebo|Placebo to match ambrisentan was administered orally once daily.
16304281|NCT00617305|Drug|Sildenafil|Sildenafil was administered at the dose previously established for each subject (20-100 mg) orally three times daily. Sildenafil was supplied as 20-mg tablets, or formulated as sildenafil citrate in 25-, 50-, or 100-mg tablets.
16304282|NCT00617305|Drug|Tadalafil|Tadalafil was administered at the dose previously established for each subject (not to exceed 40 mg per day) orally once daily. Tadalafil was supplied as 20-mg tablets.
16304283|NCT00617279|Device|GORE PROPATEN Vascular Graft|Arterial Occlusion Bypass
16304284|NCT00617279|Procedure|Disadvantaged Autologous Vein Graft|Arterial Occlusion Bypass
16304285|NCT00617266|Other|tobacco cessation intervention|Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
16304286|NCT00617266|Other|Tobacco cessation intervention|Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
16304287|NCT00617266|Other|Tobacco cessation intervention|Distribution of pamphlets containing information on the hazards of tobacco
16304288|NCT00617266|Other|Tobacco cessation intervention|Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
16304289|NCT00617253|Drug|recombinant interleukin-21|3 mcg/kg, s.c. injection
16304290|NCT00617253|Drug|sunitinib|Hard gelatine capsules, 12.5 mg
16304291|NCT00617253|Drug|recombinant interleukin-21|10 mcg/kg, s.c. injection
16304292|NCT00617253|Drug|recombinant interleukin-21|30 mcg/kg, s.c. injection
16304293|NCT00617253|Drug|recombinant interleukin-21|100 mcg/kg, s.c. injection
16304294|NCT00617240|Drug|metformin|500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks
16304295|NCT00617240|Drug|placebo|500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
16304296|NCT00617201|Drug|atomoxetine|Once daily oral dosing
16304297|NCT00617201|Drug|placebo|Once daily oral dosing - matched placebo
16304298|NCT00617188|Drug|Fulvestrant|Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.
16304299|NCT00617175|Device|Implantable Defibrillator|Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
16304300|NCT00617175|Device|Implantable Defibrillator|number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
16304301|NCT00617149|Behavioral|Supervised exercise for the prevention high weight gain|Each session starts with ca 5 minutes warm up, followed by 30 minutes of aerobic activity, including cool down. This is followed by 15 minutes of strength training of the upper and lower limbs, and special focus on the deep abdominal stabilization muscles. The last 5 minutes contains stretching, relaxation and body awareness exercises. The exercise-program follows the ACOG exercise prescription, and all aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate), measured by ratings of perceived exertion at 11-14 (somewhat hard) on the 6-20 Borg's rating scale. Control-participants are neither encouraged nor discouraged from exercising.
16304302|NCT00617136|Device|Intraoperative warming (Bair Hugger)|Intraoperative warming
16304303|NCT00617136|Device|Pre- and intraoperative warming (HotDog)|Pre- and intraoperative warming by HotDog
16304304|NCT00617136|Device|Intraoperative warming (HotDog)|Intraoperative warming
16304305|NCT00617123|Drug|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg oral tablet
16304306|NCT00617123|Drug|Placebo|matching placebo oral tablet
16304307|NCT00617110|Other|live attenuated influenza virus (LAIV) with clean air|Allergic subjects will be exposed to air followed by administration of live attenuated influenza virus
16304308|NCT00617110|Other|LAIV and diesel exhaust particles|subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
16304309|NCT00617097|Drug|lidocaine|paracervical block with lidocaine
16304310|NCT00617097|Drug|ketorolac and lidocaine|paracervical block with ketorolac and lidocaine
16304311|NCT00617084|Device|Medtronic Endeavor Resolute|Medtronic Endeavor Resolute
16304312|NCT00617084|Device|Abbott Xience V|Abbott Xience V
16304313|NCT00617071|Other|medical chart review|
16304314|NCT00617071|Other|survey administration|
16304315|NCT00617071|Procedure|fecal occult blood test|
16304316|NCT00617071|Procedure|screening colonoscopy|
16304317|NCT00617058|Drug|metformin|open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
16304318|NCT00617058|Behavioral|healthy lifestyle intervention|additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
16304319|NCT00617045|Drug|duloxetine|"Total treatment period is 12 weeks
~30mg po qd times 1 week
~60mg po qd times 11 weeks"
16304320|NCT00617032|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^10 DNase resistant particles (DRP) / mL joint volume
16304321|NCT00617032|Genetic|tgAAC94 gene therapy vector|Single dose 1x10^11 DNase resistant particles (DRP) / mL joint volume
16304322|NCT00617032|Genetic|tgAAC94 placebo|Single dose
16304323|NCT00616993|Drug|Difluprednate|Difluprednate
16304324|NCT00616993|Other|Placebo|Vehicle
16304325|NCT00616980|Biological|CD34-positive cells|
16304326|NCT00616980|Biological|CD34-positive cells|
16304327|NCT00616980|Biological|Saline and 5% autologous plasma|
16304328|NCT00616967|Drug|carboplatin|Given IV
16304329|NCT00616967|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16304330|NCT00616967|Drug|vorinostat|Given orally
16304331|NCT00616967|Other|placebo|Given orally
16304332|NCT00616954|Drug|ATG-F|ATG-f
16304333|NCT00616941|Biological|NY-ESO-1 OLP4|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection.
16304334|NCT00616941|Biological|NY-ESO-1 OLP4 + Montanide|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.
16304335|NCT00616941|Biological|NY-ESO-1 OLP4 + Montanide + Poly-ICLC|1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.
16304396|NCT00616590|Procedure|fatigue assessment and management|
16304336|NCT00616928|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted|Two intramuscular injections at Days 0 and 21.
16304337|NCT00616928|Biological|Placebo|Two intramuscular injections at Days 0 and 21.
16304338|NCT00616915|Drug|Wellbutrin XL|Wellbutrin XL 300mg daily
16304339|NCT00616902|Drug|paricalcitol injection 4 mcg/mL|Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
16304340|NCT00616902|Drug|Placebo Injection 4 mcg/mL|Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
16304341|NCT00616889|Drug|Seroquel|The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.
16304342|NCT00616876|Drug|Lactulose|Babies in the study group received lactulose in a dose of 1% in their entire mother's breast milk or preterm formula feeds (1 gram per 100 ml feeds, based on the daily volume of feeds, and evenly distributed between all the feeds for the entire duration of their hospital stay). 67% lactulose in the original preparation (Laevolac, Fresenius Kabi, Austria) was diluted by distilled water to 33.5% preparation in the pharmacy in strict sterile conditions under hood. Just before feeding the nurses added the required volume of this 33.5% lactulose solution to the ordered volume of feed to generate a final concentration of 1% lactulose in each feed.
16304343|NCT00616876|Dietary Supplement|Dextrose|Babies in the control groups were given equal volumes of the comparable placebo in all their preterm formula feeds at final concentration of 1% dextrose. The 33.5% dextrose placebo solution was prepared by dissolving dextrose (Dextrose Pulv. USP.24/BP, Roquette Frores 6280, Lestrem, France) in distilled water under heat to the point of near boiling under the same strict sterile conditions in the pharmacy. This gave a placebo solution that looked similar in color, odor and liquidity to the study solution of 33.5% lactulose. Dark bottles were used to further blind the medical team as to what solution was the baby given.
16304344|NCT00616863|Drug|Oxcarbazepine|
16304345|NCT00616850|Procedure|Continuous femoral catheter block|A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.
16304346|NCT00616850|Drug|Lidocaine|Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
16304347|NCT00616850|Other|Preservative free normal saline|Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
16304348|NCT00616837|Other|Telemedicine consultation|Outpatient consultation by help of telemedicine (video conference)
16304349|NCT00616837|Other|Standard care in orthopaedic outpatient clinic|Standard care in orthopedic outpatient clinic (usual care)
16304350|NCT00616824|Procedure|Dermamatrix to cover lateral aspect of tissue expander|Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
16304351|NCT00616824|Procedure|Serratus anterior to cover lateral aspect of tissue expander|Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
16304352|NCT00616811|Drug|vildagliptin|
16304353|NCT00616811|Drug|Sitagliptin|
16304354|NCT00616798|Drug|RO4917838|10mg po daily
16304355|NCT00616798|Drug|RO4917838|30mg po daily
16304356|NCT00616798|Drug|RO4917838|60mg po daily
16304357|NCT00616798|Drug|Placebo|po daily
16304358|NCT00616798|Drug|Standard antipsychotic therapy|As prescribed
16304359|NCT00616785|Drug|cisplatin|
16304360|NCT00616785|Drug|etoposide|
16304361|NCT00616785|Drug|irinotecan hydrochloride|
16304362|NCT00616785|Radiation|radiation therapy|
16304363|NCT00616772|Drug|ABT-335|Capsule
16304364|NCT00616772|Drug|Placebo|Capsule
16304365|NCT00616772|Other|Atorvastatin|Capsule
16304366|NCT00616759|Procedure|electroconvulsive therapy|electroconvulsive therapy as usual
16304367|NCT00616759|Procedure|electroconvulsive therapy plus propofol|electroconvulsive therapy identical to the comparator group except that propofol 0.5 mg/kg is given intravenously 15 seconds after the electrical stimulation at each treatment in order to terminate the ECT-induced seizure
16304368|NCT00616759|Drug|propofol|Propofol 0.5 mg/kg intravenously given 15 seconds following electrical stimulation
16304369|NCT00616746|Drug|Nicotine|1.0 microg/kg/min IV x 10 minutes
16304370|NCT00616746|Drug|Ethanol|IV
16304371|NCT00616733|Drug|CS-0777 tablets|0.1 mg, once-weekly, for 12 weeks
16304372|NCT00616733|Drug|CS-0777 tablets|0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
16304373|NCT00616733|Drug|CS-0777 tablets|0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
16304374|NCT00616720|Biological|aldesleukin|
16304375|NCT00616720|Biological|idiotype-pulsed autologous dendritic cell vaccine APC8020|
16304376|NCT00616720|Biological|recombinant interferon gamma|
16304377|NCT00616720|Genetic|polymerase chain reaction|
16304378|NCT00616720|Genetic|reverse transcriptase-polymerase chain reaction|
16304379|NCT00616720|Other|flow cytometry|
16304380|NCT00616720|Other|laboratory biomarker analysis|
16304381|NCT00616694|Drug|Actonel|Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
16304382|NCT00616681|Drug|Oxcarbazepine|
16304383|NCT00616668|Device|Air- Limb|
16304384|NCT00616655|Drug|eszopiclone|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
16304385|NCT00616655|Drug|eszopiclone|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
16304386|NCT00616655|Drug|Placebo|Placebo total daily dose 0.9 mg
16304387|NCT00616642|Drug|rosiglitazone maleate|Given orally
16304388|NCT00616629|Drug|AZD1305|Intravenous infusion
16304389|NCT00616616|Procedure|single incision laparoscopic surgery|Surgery will be performed with ine laparoscopic incision
16304390|NCT00616603|Drug|Ropivacaine|20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once.
16304391|NCT00616603|Drug|Dexamethasone|8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once.
16304392|NCT00616603|Drug|Dexamethasone|2ml(8mg)Dexamethasone given once intravenously.
16304393|NCT00616603|Drug|Normal Saline|2ml of normal saline given once intravenously.
16304394|NCT00616590|Other|medical chart review|
16304395|NCT00616590|Other|questionnaire administration|
16304398|NCT00616577|Drug|Ropivacaine|caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
16304399|NCT00616577|Drug|Ropivacaine|caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
16304400|NCT00616577|Drug|Ropivacaine|local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
16304401|NCT00616564|Drug|GM-CSF|Concomitant Priming with GM-CSF
16304402|NCT00616551|Drug|C2L-OCT-01 PR, 30 mg|Administered by deep IM injection (gluteus) on days 1 and 42
16304403|NCT00616551|Drug|Octreotide acetate prolonged release, 30 mg|Administered by deep IM (gluteus) on Days 1, 28 and 56
16304404|NCT00616538|Device|Epiceram(r)|Topical barrier repair emulsion cream
16304405|NCT00616538|Drug|Fluticasone Propionate 0.05%|Topical mid-strength steroid
16304406|NCT00616512|Procedure|GF Strong Water Protocol|The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol.
16304407|NCT00616499|Drug|gefitinib|
16304408|NCT00616499|Procedure|neoadjuvant therapy|
16304409|NCT00616499|Procedure|therapeutic conventional surgery|
16304410|NCT00616486|Device|repetitive transcranial magnetic stimulation|6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
16304411|NCT00616486|Device|sham (placebo)|Sham treatment will mimic active treatment mentioned above.
16304412|NCT00616460|Drug|Bivalirudin|Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250
16304413|NCT00616447|Device|Repetitive transcranial magnetic stimulation|6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
16304414|NCT00616447|Device|placebo sham|Sham treatment will mimic active treatment mentioned above.
16304415|NCT00616434|Drug|BG9418 (Interferon beta-1a)|Avonex IM injection, self-administered per protocol
16304416|NCT00616434|Drug|Placebo|Placebo IM injection, self-administered per protocol.
16304417|NCT00616421|Biological|MenACWY-CRM|1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
16304418|NCT00616421|Biological|MenACWY-CRM|2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
16304419|NCT00616421|Biological|Licensed meningococcal ACWY vaccine|1 injection of the licensed meningococcal ACWY was administered intramuscularly
16304420|NCT00616408|Drug|Octreotide-LAR|Initial dose is 20 mg every 28 d for three months, then the dose is down-titrated to 10 mg/q28d if GH levels are below 1 ng/ml, up-titrated to 30 mg/q28d if GH levels are above 10 ng/ml and remains to 20 mg/q28 d if GH is between 1-10 ng/ml
16304421|NCT00616395|Device|No intervention|
16304422|NCT00616382|Drug|Indomethacin|IV indomethacin starting at a dose of 0.4 mg/kg given over 30 minutes, increased daily by increments of 0.2 mg/kg/dose and given at intervals of 12 hours until a maximum dose of 1 mg/kg is reached, or until a total indomethacin dose of 6 mg/kg has been given. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later, using the same dose used in the last indomethacin infusion.
16304423|NCT00616382|Drug|Pentoxifylline|IV indomethacin will be re-started at a dose of 0.2 mg/kg to run over 30 minutes at 12 hour intervals to be given concurrently with pentoxifylline (5 mg/kg/hour to run over 6 hour once a day for a maximum of 6 days. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later and another day of pentoxifylline infusion, provided that the 6 day maximum has not yet been
16304424|NCT00616343|Drug|Zonisamide|100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
16304425|NCT00616330|Drug|clindamycin phosphate/butoconazole nitrate|semi solid, single dose
16304426|NCT00616330|Drug|clindamycin phosphate|semi solid, single dose
16304427|NCT00616330|Drug|butoconazole nitrate|semi solid, single dose
16304428|NCT00616304|Drug|L-arginine hydrochloride|Patients will be randomized in two blocks of 18. The first block of 18 patients will receive either 12 g L-arginine or saline placebo. If safety is demonstrated in the first block, a further 18 patients will be enrolled in the second block and randomized to receive either 24g arginine or saline placebo Block 1: Standard RSMM artesunate regimen for severe falciparum malaria plus 12g of L-arginine diluted to a 10% solution and given over 8 hours (n=12); Block 2: Standard RSMM artesunate regimen for severe falciparum malaria plus a 24g dose of L-arginine diluted to a 10% solution given over 8 hours (n=12) Phase 2b: To evaluate any additional benefits of a longer infusion, a further 24 patients will receive L-arginine infusion 1.5g/hour for 24 hours
16304429|NCT00616304|Other|Normal saline|Patients with severe malaria will be randomized in two blocks of 18. The first block of 18 patients will receive either 12 g L-arginine or saline placebo. If safety is demonstrated in the first block, a further 18 patients will be enrolled in the second block and randomized to receive either 24g arginine or saline placebo. Blocks 1 and 2: Standard RSMM antimalarial artesunate regimen for severe falciparum malaria plus saline placebo, 240 ml given over 8 hours (n=12).
16304430|NCT00616291|Biological|NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine|
16304431|NCT00616265|Device|CPAP|Pressure device on airway to maintain it open
16304432|NCT00616239|Drug|20-30% Salicylic Acid peels to the right side of the face|Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.
16304433|NCT00616239|Drug|20-30% Salicylic Acid peels to the left side of the face|Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face
16304434|NCT00616213|Biological|filgrastim|filgrastim will be administered at a standard dose and schedule
16304435|NCT00616213|Drug|PR104|PR104 is administered intravenously once every 21 days
16304628|NCT00614640|Biological|Placebo patch|10% dextrose (D-glucose) solution
16304436|NCT00616213|Other|F-18-fluoromisonidazole|F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan
16304437|NCT00616200|Other|Very low carbohydrate diet|4 weeks on strictly controlled low carbohydrate diet
16304438|NCT00616187|Drug|interferon beta treatment to add-on atorvastatin treatment|IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
16304439|NCT00616187|Drug|untreated to atorvastatin treatment|no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
16304440|NCT00616174|Procedure|Active warming with Bair Hugger blanket|Standard care at BC Women's Hospital plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C). Warming will continue until the end of surgery unless otherwise requested by the mother.
16304441|NCT00616161|Drug|Istaroxime|0.5 microgram/kg/min IV for 6 hours
16304442|NCT00616161|Drug|Istaroxime|1.0 microgram/kg/min IV for 6 hours
16304443|NCT00616161|Drug|Istaroxime|1.5 microgram/kg/min IV for 6 hours
16304444|NCT00616161|Drug|Placebo|Placebo
16304445|NCT00616148|Drug|YKP3089|Oral dosage form
16304446|NCT00616148|Drug|Placebo|
16304447|NCT00616135|Procedure|ADRC-Enhanced Autologous Fat Transplant|Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.
16304448|NCT00616122|Drug|cyclophosphamide|
16304449|NCT00616122|Drug|methotrexate|
16304450|NCT00616122|Drug|sunitinib malate|
16304451|NCT00616122|Other|laboratory biomarker analysis|
16304452|NCT00616109|Drug|sunitinib|Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
16304453|NCT00616096|Procedure|immunoadsorption|"First cycle: week 1, day 1-5
~Second cycle: week 5, day 1-5"
16304454|NCT00616070|Drug|Difluprednate|Difluprednate
16304455|NCT00616070|Other|Placebo|Vehicle
16304456|NCT00616057|Dietary Supplement|Synergy 1|8 grams/day during the first week and then 8 grams twice a day during 3 months
16304457|NCT00616057|Dietary Supplement|maltodextrin|8 grams/day during the first week and then 8 grams twice a day during 3 months
16304458|NCT00616044|Procedure|continuous spinal anesthesia|bupivacaina isobaric 0.5%, 5 mg
16304459|NCT00616044|Procedure|Spinocath a catheter for continuous spinal anesthesia|Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric
16304460|NCT00616044|Procedure|combined spinal epidural anesthesia|CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany
16304461|NCT00616031|Drug|carboplatin|
16304462|NCT00616031|Drug|nitroglycerin|
16304463|NCT00616031|Drug|paclitaxel|
16304464|NCT00616018|Drug|acetaminophen|4 g/day for 10 consecutive days
16304465|NCT00616005|Drug|Temodar and Irinotecan|Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle & every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.
16304466|NCT00615992|Drug|Tiotropium|
16304467|NCT00615979|Device|Miniature echo machine|Images captured and real-time and store-and-forward file transfers performed
16304468|NCT00615966|Drug|Diannexin|single dose, 200 µg/kg IV
16304469|NCT00615966|Drug|Placebo|Single dose, IV
16304470|NCT00615966|Drug|Diannexin|Single dose, 400 µg/kg IV
16304471|NCT00615940|Drug|WX-671|capsules taken per os once daily until progression or toxicity
16304472|NCT00615940|Drug|placebo|capsule taken per os once daily until progression or toxicity
16304473|NCT00615927|Drug|Imatinib Mesylate & Hydroxyurea|"Imatinib administered orally on daily. Imatinib is local irritant & must be taken in sitting position; mini of 2hrs should be allowed between last drug intake & going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues.
~Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 & continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts."
16304474|NCT00615901|Drug|cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim|C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
16304475|NCT00615888|Procedure|Fast track patient management|no bowel washout, patient controlled epidural anesthesia, early enteral feeding
16304476|NCT00615888|Procedure|Traditional management|preoperative bowel washout, patient controlled analgesia, delayed start of enteral feeding
16304477|NCT00615875|Drug|naproxen|opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
16304478|NCT00615875|Drug|placebo|opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice
16304549|NCT00615238|Behavioral|Diet plus short bouts|Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week
16304671|NCT00614250|Drug|AVE0657|capsules once a day at bedtime
16304479|NCT00615862|Other|Observational study; no interventions|Validated questionnaires will be administered. Blood samples will be analyzed for levels of immune markers as well as cortisol. This is an observational study and patients will not undergo any treatment as part of study participation. Patients will not receive medications or other interventions if they participate in the study. Blood samples analyzed are from samples remaining in the hospital laboratory that were collected as part of routine patient care and destined to be discarded.
16304480|NCT00615849|Procedure|thoracoscopic surgery|stapled wedge resection of the lung mechanical pleural abrasion
16304481|NCT00615836|Drug|Desmopressin Melt|An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
16304482|NCT00615823|Drug|Atorvastatin|Patients were assigned to receive 10 mg of atorvastatin for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.
16304483|NCT00615823|Drug|Placebo|Patients were assigned to receive 10 mg of placebo for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.
16304484|NCT00615810|Drug|Atripla|Open label once daily for oral administration to be taken on an empty stomach
16304485|NCT00615810|Drug|Kivexa plus Sustiva|Open label once daily for oral administration
16304486|NCT00615797|Biological|Intravenous immunoglobulin|intravenous immunoglobulin 2g/kg total given over 2 days
16304487|NCT00615797|Drug|standard interventions penicillin VK and haloperidol|Penicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day
16304488|NCT00615784|Drug|Bexarotene|Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
16304489|NCT00615771|Procedure|Day 3 embryo transfer|Standard of care
16304490|NCT00615771|Procedure|Day 2 embryo transfer|Embryos are transferred 1 day prior to standard of care
16304491|NCT00615758|Drug|Erlotinib|Erlotinib at the dose of 150 mg orally once a day continually until progression
16304492|NCT00615745|Drug|Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg|Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime.
16304493|NCT00615732|Procedure|Qigong|18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
16304494|NCT00615732|Procedure|exercise therapy|18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
16304495|NCT00615706|Other|No intervention|no intervention
16304496|NCT00615693|Drug|AEB071|
16304497|NCT00615667|Drug|tacrolimus (FK506)|Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
16304498|NCT00615654|Other|aquatic physical therapy|The aquatic physiotherapy program for the SG was applied twice a week, in groups of six to seven people, with sessions lasting 40 minutes, over a 12-week period. The Control Group protocol included maintenance of the individuals' medication therapy and absence of any physical activity during the study period.
16304499|NCT00615615|Drug|Levetiracetam|"high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
~low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less"
16304500|NCT00615615|Drug|Placebo|Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy
16304501|NCT00615602|Drug|Docetaxel|Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
16304502|NCT00615602|Drug|Trastuzumab|Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months
16304503|NCT00615602|Drug|Epirubicin|Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
16304504|NCT00615602|Drug|Cyclophosphamide|Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
16304505|NCT00615602|Drug|5-fluoruracil|5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
16304506|NCT00615602|Drug|Granulocyte-colony stimulating growth factor|rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
16304507|NCT00615602|Drug|Trastuzumab|Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months
16304508|NCT00615589|Drug|Fludarabine/Busulfan x 4 days|"Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.
~The Fludarabine shall be administered prior to the Busulfan each day."
16304509|NCT00615589|Procedure|stem cell transplant|Allogeneic, peripheral blood stem cell transplant
16304510|NCT00615576|Drug|SB-656933|SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.
16304511|NCT00615576|Drug|Placebo|A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
16304512|NCT00615563|Behavioral|NO BI Drug administered|
16304513|NCT00615550|Drug|progesterone|8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
16304514|NCT00615550|Drug|placebo|vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
16304550|NCT00615238|Behavioral|Diet plus moderate lifestyle activity|Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
16304551|NCT00615225|Procedure|Muscle biopsy|Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
16304515|NCT00615537|Procedure|Laser Ablation of Thyroid Nodule|Laser ablation using a laser generator, disposable fiberoptic laser fiber, cooling catheter and pump, will be performed under conscious sedation. Ultrasound will be used to localize masses. Local anesthesia will be administered both intradermally and subcutaneously. The laser applicator will be placed into the mass and laser energy will be delivered at 15W for 30-120 seconds. Real-time ultrasound monitoring of the ablation front will be used to ensure complete treatment of the target lesion. In larger masses applicators may be placed of the applicator into multiple locations. The number of locations will be determined by the treatment team, and based on lesion morphology, size, location, and accessibility.
16304516|NCT00615524|Drug|exemestane and pazopanib|
16304517|NCT00615511|Dietary Supplement|placebo pregnenolone|Sugar pill, taken twice a day
16304518|NCT00615511|Dietary Supplement|pregnenolone|500mg in tablet form taken orally twice a day
16304519|NCT00615472|Drug|Isoflurane|Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
16304520|NCT00615472|Drug|Remifentanil|Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
16304521|NCT00615472|Drug|Propofol|Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
16304522|NCT00615459|Drug|Indacaterol|Indacaterol 150 μg or 300 μg, delivered via SDDPI
16304523|NCT00615459|Drug|Tiotropium|Tiotropium 18 μg once daily delivered via inhalation device
16304524|NCT00615459|Drug|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
16304525|NCT00615446|Drug|SU011248; Gemcitabine|Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
16304526|NCT00615433|Drug|Lurasidone|120mg/day
16304527|NCT00615433|Drug|Olanzapine|15mg/day
16304528|NCT00615433|Drug|Placebo comparator|Placebor Comparator
16304529|NCT00615433|Drug|Lurasidone 40 mg tablets|Lurasidone 40 mg tablets
16304530|NCT00615420|Dietary Supplement|manuka honey|Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
16304531|NCT00615420|Dietary Supplement|placebo gel|Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
16304532|NCT00615394|Procedure|intramyocardial bone marrow stem cells implantation|Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.
16304533|NCT00615381|Drug|Insulin|insulin infusion (0-10 U/hr) vs. 0.3 U/kg/hr and boluses (0-8 U) adjusted every 15 minutes during the intraoperative period to maintain intraoperative euglycemia (blood glucose levels 80-120 mg/dL)
16304534|NCT00615368|Drug|Epoetin alfa|1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.
16304535|NCT00615368|Drug|Isotonic NaCl (Placebo)|1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
16304536|NCT00615355|Radiation|UVB 311 nm radiation|UVB 311 nm radiation randomized to one half of the transplanted vitiligo lesion given 2 times a week for 3 months; the other half of the transplanted lesion remains UV-non-irradiated
16304537|NCT00615355|Device|UVB 311nm|Repeated UVB 311nm narrowband irradiation (24 exposures)
16304538|NCT00615316|Drug|Guaraná|Guaraná extract 75mg/day
16304539|NCT00615316|Drug|Placebo|Placebo 1tab/d
16304540|NCT00615303|Drug|Simethicone|2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded
16304541|NCT00615303|Drug|Placebo|2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day
16304542|NCT00615290|Drug|tipranavir|
16304543|NCT00615277|Dietary Supplement|Omega-3 fatty acids|600 mg EPA 120mg DHA daily, 16 weeks
16304544|NCT00615264|Drug|DiaPep277|1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
16304545|NCT00615264|Drug|Placebo|Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
16304546|NCT00615251|Drug|DR-2011|Progesterone vaginal ring for approximately 10 weeks
16304547|NCT00615251|Drug|Crinone 8%|progesterone vaginal gel for approximately 10 weeks
16304548|NCT00615238|Behavioral|Diet plus continuous bouts|Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
16304627|NCT00614640|Biological|DermaVir patch|DNA Vaccine
16304552|NCT00615212|Drug|GSK376501|GSK376501 oral tablet will be available with dosing strengths of 75 milligrams administered once daily. Biconvex, It will be a round, white film-coated tablets with both plain sides and no identifying markings.
16304553|NCT00615212|Drug|Midazolam|Midazolam oral syrup will be available with a dose of 5 milligrams administered once daily. It will be a clear, red to purplish-red, cherry-flavored syrup.
16304554|NCT00615212|Drug|Rosiglitazone|Rosiglitazone oral tablet will be available with dosing strengths of 4 milligrams administered once daily. It will be a orange colored tablet debossed with SB on one side and 4 on the other.
16304555|NCT00615212|Drug|Flurbiprofen|Rosiglitazone oral tablet will be available with dosing strengths of 50 milligrams administered once daily. It will be a blue, oval, film coated tablet.
16304556|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
16304557|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
16304558|NCT00615199|Drug|CP-690,550|administration via oral route twice daily
16304559|NCT00615199|Drug|Placebo|administration via oral route twice daily
16304560|NCT00615186|Drug|Neuradiab + Radiotherapy + Temozolomide|"Prior Surgery
~Rickham Catheter placement 99mTc-DTPA Flow Study
~Neuradiab Dosimetry Study
~Neuradiab Therapeutic Dose Administration
~Radiation Therapy (XRT) + Temozolomide:
~XRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks.
~Post-Radiation Temozolomide Therapy:
~Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment."
16304561|NCT00615186|Drug|Radiation Therapy + Temozolomide|"Prior Surgery: Gross total resection (< 1 cm. enhancing rim)
~Radiation Therapy (XRT) + Temozolomide:
~XRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks
~Post-Radiation Temozolomide Therapy:
~Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment."
16304562|NCT00615173|Drug|tacrolimus (FK506)|Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
16304563|NCT00615173|Drug|cyclophosphamide or azathioprine|Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.
16304564|NCT00615160|Drug|PTK787/ZK 222584|PTK-ZK capsules taken orally with a daily flat dose of 1250 mg
16304565|NCT00615160|Drug|Dacarbazine|Dacarbazine 850 mg/m² on day 1 q4w
16304566|NCT00615147|Procedure|CT pulmonary angiogram and d-dimer draw|A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
16304567|NCT00615134|Drug|enfuvirtide [Fuzeon]|90mg sc bid
16304568|NCT00615134|Drug|Optimized background ARV therapy|As prescribed
16304569|NCT00615095|Other|self-administered questionnaire and blood draw|Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
16304570|NCT00615095|Other|self-administered questionnaire and blood draw|Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
16304571|NCT00615095|Other|health questionnaire, blood draw and skin exam|Numbers will be randomly selected from a pool of prefixes. Numbers will be screened by computer for being working, non-business, non-fax, and non-modem numbers. After establishing eligibility for the study, we will send the potential control a letter further explaining the purpose of the study and its requirements. An interviewer will then call to arrange an appointment. During the interview, the subject will sign informed consent, be given the public health questionnaire, have 30 ml of blood drawn, and undergo the skin examination of arms and back.
16304572|NCT00615082|Behavioral|Mindfulness-Based Stress Reduction|An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
16304573|NCT00615082|Behavioral|Caregiver Education & Social Support|An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
16304574|NCT00615069|Device|31 mm GORE EXCLUDER® AAA Endoprosthesis|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA)
16304575|NCT00615056|Drug|Bevacizumab (avastin)|Bevacizumab intravenous [IV] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
16304576|NCT00615056|Drug|FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])|Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous [IV] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
16304577|NCT00615056|Drug|AG-013736 (axitinib)|Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
16304578|NCT00615056|Drug|FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])|Oxaliplatin (85 mg/m²) intravenous infusion [IV] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
16304579|NCT00615056|Drug|AG-013736 (axitinib)|Axitinib is given at a starting dose of 5 mg twice daily [BID] continuous dosing until disease progression, intolerance or withdrawal of consent.
16304580|NCT00615056|Drug|FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])|Irinotecan (180 mg/m²) intravenous infusion [IV] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
16304581|NCT00615056|Drug|Bevacizumab (avastin)|Bevacizumab intravenous infusion [IV] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
16304582|NCT00615056|Drug|FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])|Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion [IV] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
16304583|NCT00615043|Procedure|Bladder biopsy|provision of bladder tissue via cystoscopic biopsy during planned TURBT
16304584|NCT00615030|Drug|Indacaterol|300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
16304585|NCT00615030|Drug|Salmeterol|50 µg twice daily delivered via dry powder inhaler (DPI)
16304586|NCT00615030|Drug|Placebo to Indacaterol|Placebo matching indacaterol was delivered via SDDPI.
16304587|NCT00615030|Drug|Placebo to Salmeterol|Placebo matching salmeterol was delivered via DPI
16304588|NCT00615017|Drug|AZD9773 (CytoFab)|intravenous infusions
16304589|NCT00615017|Other|Placebo|Placebo
16304590|NCT00614991|Drug|Raltegravir|400mg BID
16304591|NCT00614991|Drug|Fosamprenavir|1400mg BID, 700 mg BID or 1400 mg QD
16304592|NCT00614991|Drug|Ritonavir|100 mg BID or QD
16304593|NCT00614978|Drug|lapatinib and temozolomide|Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.
16304594|NCT00614965|Drug|Irinotecan|Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
16304595|NCT00614965|Drug|Cisplatin|Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
16304596|NCT00614965|Drug|Pemetrexed|Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles
16304597|NCT00614952|Device|PSG (polysomnography)|POLYSOMNOGRAPHY
16304598|NCT00614952|Other|PR (respiratory polygraphy)|respiratory polygraphy: level III of AASM
16304599|NCT00614939|Drug|Saxagliptin|2.5 mg once daily oral dose
16304600|NCT00614939|Drug|Placebo|Placebo
16304601|NCT00614926|Drug|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
16304602|NCT00614926|Drug|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
16304603|NCT00614913|Radiation|Proton radiation therapy|A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
16304604|NCT00614874|Drug|rosiglitazone|2mg, 4mg, 8mg
16304605|NCT00614861|Other|Non-cancer pain management survey|Non-cancer pain management survey
16304606|NCT00614848|Device|Endeavor drug eluting coronary stent|Zotarolimus coated coronary stent (10ug/mm)
16304607|NCT00614835|Drug|Docetaxel plus Gemcitabine|Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles
16304608|NCT00614822|Drug|Carboplatin, Pemetrexed and Bevacizumab|Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
16304609|NCT00614809|Drug|gefitinib|gefitinib 250mg qd until disease progression or unacceptable toxicity.
16304610|NCT00614796|Behavioral|Coach, using a stepcounter with exercise counseling|5 counseling meetings of 30 min in the first 3 months. In counseling, patients will be stimulated individually to enhance a physically active lifestyle.
16304611|NCT00614770|Procedure|standard of care colonoscopy|"Standard White Light Colonoscopy
~one exam per patient"
16304612|NCT00614770|Procedure|colonoscopy|"Narrow Band Imaging Colonoscopy
~one exam per patient"
16304613|NCT00614770|Procedure|standard of care colonoscopy|"High Definition White Light Colonoscopy
~one exam per patient"
16304614|NCT00614757|Drug|N-acetylcysteine 20% 4ml|N-acetylcysteine 20% 4ml
16304615|NCT00614757|Drug|N-acetylcysteine 20% in 4 ml|N-acetylcysteine 20% in 4 ml
16304616|NCT00614744|Procedure|Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
16304617|NCT00614744|Procedure|Normothermic Control|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
16304618|NCT00614731|Biological|KLH carrier-protein|KLH carrier-protein vaccination containing no other protein or antibodies
16304619|NCT00614705|Drug|PH-797804|6 mg dose in oral capsule form, once daily for 28 days
16304620|NCT00614705|Drug|Placebo|oral capsule form, once daily for 28 days
16304621|NCT00614679|Drug|catheter lock solution consisting of N-acetylcystein, tigecycline and heparin|N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution
16304622|NCT00614666|Drug|nikkomycin Z|"Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.
~50 mg BID (n=8) vs placebo capsule BID (n=2)
~250 mg BID (n=8) vs Placebo capsule BID (n=2)
~500 mg BID (n=8) vs Placebo capsule BID (n=2)
~750 mg TID (n=8) vs Placebo capsule TID (n=2)
~At least 4 subjects complete lower dose before randomization includes next higher dose, thus there are 4 arms for active intervention and corresponding placebos.
~Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization."
16304623|NCT00614653|Drug|Bevacizumab|5 mg/kg IV Over 90 Minutes Every 2 Weeks
16304624|NCT00614653|Drug|Erlotinib|100 mg by mouth Once Daily on days with radiation.
16304625|NCT00614653|Drug|Capecitabine|400 mg/m^2 PO Twice Daily on days with radiation.
16304626|NCT00614653|Radiation|Radiation Therapy|Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
16304629|NCT00614614|Biological|GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)|One dose in the booster phase as intramuscular injection
16304630|NCT00614614|Biological|GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)|Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
16304631|NCT00614614|Biological|Infanrix®|One dose as intramuscular injection
16304632|NCT00614614|Biological|ActHIB®|Three doses in the priming phase as intramuscular injection
16304633|NCT00614614|Biological|Pediarix®|Three doses in the priming phase as intramuscular injection
16304634|NCT00614601|Biological|HyperAcute(R)-Pancreatic Cancer Vaccine|100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months
16304635|NCT00614588|Device|Body temperature thermometers|Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.
16304636|NCT00614562|Device|Neurally adjusted ventilatory assist (NAVA)|NAVA for 72 hours
16304637|NCT00614536|Drug|Rabeprazole Sodium|10mg - 20mg tablet once or twice daily for 12weeks
16304638|NCT00614523|Drug|Placebo|Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
16304639|NCT00614523|Biological|Romiplostim|Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
16304640|NCT00614510|Device|CardioWest temporary Total Artificial Heart (TAH-t)|The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines.
16304641|NCT00614484|Radiation|Proton Radiation Therapy|A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
16304642|NCT00614484|Drug|Taxol|200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
16304643|NCT00614484|Drug|Carboplatin|AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
16304644|NCT00614471|Drug|Entecavir|0.5mg po daily for 24 weeks
16304645|NCT00614471|Drug|Entecavir|0.5mg po daily from week 13 to week 36
16304646|NCT00614471|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc/week for 48 weeks
16304647|NCT00614471|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc/week from week 21 to week 68
16304648|NCT00614458|Drug|Raltegravir; valproic acid|raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily
16304649|NCT00614445|Drug|doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg|up to 4 tablets daily, titrated according to the protocol
16304650|NCT00614445|Drug|Placebo|2 to 4 tablets daily titrated according to the protocol
16304651|NCT00614419|Device|Prolene Polypropylene Mesh|The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0.
16304652|NCT00614419|Device|Surgisis Inguinal Hernia Matrix|The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0.
16304653|NCT00614406|Drug|Celebrex|One 400mg tablet daily.
16304654|NCT00614406|Drug|Placebo|One tablet daily.
16304655|NCT00614393|Biological|dalotuzumab|IV infusion
16304656|NCT00614393|Drug|irinotecan hydrochloride|IV infusion
16304657|NCT00614393|Biological|cetuximab|IV infusion
16304658|NCT00614393|Drug|placebo|IV infusion
16304659|NCT00614380|Drug|telmisartan/amlodipine 40/5 mg fixed combination|
16304660|NCT00614380|Drug|telmisartan/amlodipine 80/5 mg fixed combination|
16304661|NCT00614354|Drug|99mTc-glucarate solution|Patients will receive a single 22 - 27 mCi bolus intravenous dose of 99mTc-glucarate solution, as soon as possible after their arrival in the emergency department or the chest pain center
16304662|NCT00614341|Device|MedRelief SE 55|4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
16304663|NCT00614328|Drug|Naltrexone, Baclofen, Placebo and Behavior Therapy|Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
16304664|NCT00614315|Device|FLAIR™ Endovascular Stent Graft|The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).
16304665|NCT00614302|Drug|TPV|
16304666|NCT00614289|Device|Epikeia Coatings|Topical skin coating
16304667|NCT00614276|Behavioral|Focus Group|To evaluate a multimedia intervention program for women with cancer-related sexual dysfunction.
16304668|NCT00614276|Behavioral|TENDRILS|Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
16304669|NCT00614276|Behavioral|Questionnaires|The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function. The questionnaires take about 30-45 minutes to complete.
16304670|NCT00614276|Behavioral|Sexual Counseling Sessions|Attend 3 sexual counseling sessions at M. D. Anderson.
16304672|NCT00614250|Drug|placebo|capsules once a day at bedtime
16304673|NCT00614224|Behavioral|treadmill exercise training|3 months (3 times/week) progressive graded aerobic treadmill training with a duration of 10-45 min per training session
16304674|NCT00614211|Procedure|Total Abdominal Radical Hysterectomy|In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
16304675|NCT00614211|Procedure|Total Laparoscopic or Robotic Radical Hysterectomy|In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised.
16304676|NCT00614198|Other|Gluten- and casein-free diet|Removal of foods containing gluten (cereal produce) and casein (dairy produce)
16304677|NCT00614172|Radiation|Proton radiation therapy|Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
16304678|NCT00614159|Drug|Ketamine|Weight based dosage for Peds subjects, used for duration of the endoscopy.
16304679|NCT00614159|Drug|Propofol|Weight based dosage for Peds subjects, used for duration of the endoscopy.
16304680|NCT00614146|Device|MARS device|10 treatments with the MARS system during the first three weeks after enrollment of 5-8 hours each.
16304681|NCT00614146|Procedure|Standard medical therapy|Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
16304682|NCT00614146|Procedure|Standard medical therapy|Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
16304683|NCT00614133|Other|Intravenous nutrition with glucose and amino acids|Glucose and amino acids intravenously starting 20 hours before the operation until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
16304684|NCT00614133|Other|Intravenous nutrition with glucose and amino acids.|Glucose and amino acids intravenously starting with surgical skin incision until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
16304685|NCT00614120|Drug|liraglutide|0.6 mg/day, s.c. (under the skin) injection
16304686|NCT00614120|Drug|placebo|Glimepiride placebo, capsules
16304687|NCT00614120|Drug|liraglutide|1.2 mg/day, s.c. (under the skin) injection
16304688|NCT00614120|Drug|liraglutide|1.8 mg/day, s.c. (under the skin) injection
16304689|NCT00614120|Drug|glimepiride|Capsules, 4.0 mg/day
16304690|NCT00614120|Drug|metformin|Tablets, 1.5-2.0 g/day
16304691|NCT00614120|Drug|placebo|Liraglutide placebo, s.c. (under the skin) injection
16304692|NCT00614081|Device|Contrast-enhanced dynamic MRI|
16304693|NCT00614068|Behavioral|Trauma-focused cognitive behavioral therapy (TF-CBT)|TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
16304694|NCT00614068|Behavioral|Treatment as usual (TAU)|TAU outpatient sessions will include routine community care and nontrauma-focused therapy.
16304695|NCT00614055|Drug|insulin degludec/insulin aspart|Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
16304696|NCT00614055|Drug|insulin degludec/insulin aspart|Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
16304697|NCT00614055|Drug|insulin glargine|Treat-to-target dose titration scheme, injection s.c., once daily
16304698|NCT00614055|Drug|metformin|Tablets, 1500-2000 mg/day
16304699|NCT00614042|Drug|TRU-016 (anti-CD37 protein therapeutic)|TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
16304700|NCT00614029|Device|Sumatriptan (via Intraject System)|0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
16304701|NCT00614016|Drug|Sodium ST20|single administration of oral dosage form
16304702|NCT00614003|Behavioral|Decision support skills building Intervention|Decision support skills
16304703|NCT00613964|Drug|Carperitide heart failure therapy|carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
16304704|NCT00613964|Drug|Standard heart failure therapy|Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
16304705|NCT00613951|Drug|insulin degludec/insulin aspart|Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
16304706|NCT00613951|Drug|insulin degludec/insulin aspart|Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
16304707|NCT00613951|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme, injection s.c., twice daily
16304708|NCT00613951|Drug|metformin|Tablets, 1500-2000 mg/daily
16304709|NCT00613938|Drug|Tapentadol (CG5503)|50mg capsule q4-6 hrs for 3 days
16304710|NCT00613938|Drug|Tapentadol (CG5503)|75mg capsule q4-6 hrs for 3 days
16304711|NCT00613938|Drug|oxycodone|10mg capsule q4-6 hrs for 3 days
16304712|NCT00613938|Drug|placebo|1 capsule q4-6 hrs for 3 days
16304713|NCT00613925|Device|Pipelle de Cornier|A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.
16304714|NCT00613925|Device|Explora curette|The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.
16304715|NCT00613912|Other|Magnetic Resonance Imaging|"Morphological sequences
~Arterial Spin Labelling (Perfusion)
~Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter"
16304716|NCT00613899|Other|telesurveillance|A telesurveillance program for cough assistance will be approched by the use of an in-exoflator device. Measurement of oxygen saturation (SpO2) will be performed by a Nonin 9500 oxymeter (Minneapolis Plymouth USA).
16304744|NCT00613678|Behavioral|Education|The health education program is based on educational materials from the Arthritis Foundation.
16304745|NCT00613665|Biological|helicobacter pylori vaccine|Experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
16305030|NCT00611650|Other|placebo|Given orally
16304717|NCT00613886|Device|Programmable Shunt Insertion (Codman, Medtronic)|Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied.
16304718|NCT00613886|Behavioral|Assessments in physical therapy, occupational therapy, and speech therapy|Follow-up testing to be administered by trained Physician Assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, Mini-Mental Status Exam, 9-hole Grooved Pegboard, Motor Visual Perception Test (MVPT), Modified Rankin Score (MRS)
16304719|NCT00613873|Procedure|Colonoscopy and Questionnaire|Pt is asked to complete attitude and belief questionnaire then have a Colonoscopy. Then within 6 weeks post colonoscopy a final telephone interview.
16304720|NCT00613860|Device|Zephyr endobronchial valve|Endobronchial valve system to redirect the airflow within the bronchial system
16304721|NCT00613847|Radiation|PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab|Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
16304722|NCT00613847|Radiation|PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab|Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
16304723|NCT00613834|Drug|Lidocaine|5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
16304724|NCT00613834|Drug|Sterile Saline|5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
16304725|NCT00613821|Drug|Lidocaine|5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
16304726|NCT00613821|Drug|Lidocaine|Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
16304727|NCT00613808|Drug|Nitric Oxide 200ppm Group B|200 ppm, 8hrs / day for 6 weeks
16304728|NCT00613795|Dietary Supplement|Lactobacillus GG|Every 12 hours, the contents of a single capsule containing Lactobacillus GG will be suspended in 3 ml of water-soluble jelly. The suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second capsule will be suspended in 10 ml of sterile water and pushed through the NG tub followed by 10 mL of air to ensure complete administration.
16304729|NCT00613795|Dietary Supplement|placebo|Every 12 hours, the contents of a single identical placebo capsule containing the inert plant carbohydrate inulin will be suspended in 3 ml of water-soluble jelly. This suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second placebo capsule will be suspended in 10 ml of sterile water and pushed through eh NG tube followed by 10 mL of air to ensure complete administration
16304730|NCT00613782|Drug|Reandron 1000|1000mg at 0,6,18,30 weeks
16304731|NCT00613782|Drug|placebo|placebo injection 0,6.18.30 weeks
16304732|NCT00613769|Drug|trimethoprim-sulfamethoxazole + metronidazole|trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
16304733|NCT00613769|Drug|cefuroxime and metronidazole|cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
16304734|NCT00613743|Drug|mouth wash with morphine|morphine solution 0.2% concentration; 15ml per unit mouthwash 6 time à day
16304735|NCT00613743|Drug|placebo|placebo solution Quinine diHCl 0.3% at 50 mg/15 ml mouthwash 6 time/day
16304736|NCT00613730|Drug|Gemcitabine|Intravenous administration
16304737|NCT00613730|Drug|panitumumab|Intravenous administration
16304738|NCT00613717|Dietary Supplement|folic acid + iron prenatally, vits A & D + iron postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D."
16304739|NCT00613717|Dietary Supplement|folic acid + iron prenatally, vitamins A & D postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D."
16304740|NCT00613717|Dietary Supplement|folic acid prenatally, vitamins A & D + iron postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D."
16304741|NCT00613717|Dietary Supplement|folic acid prenatally, vitamins A & D postnatally|"Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid.
~Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D."
16304742|NCT00613691|Drug|SPI-1620|SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds
16304743|NCT00613678|Behavioral|Activity Strategy Training|The AST component will involve training in specific behavioral and environmental strategies to facilitate performance in daily activities and routines. The activity strategy training group sessions will use education, group discussion, and demonstration and practice of techniques to facilitate activity performance. Homework assignments will be given after many of the sessions to practice and reinforce concepts learned.
16304746|NCT00613665|Biological|helicobacter pylori vaccine|Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly
16304747|NCT00613665|Biological|helicobacter pylori vaccine|Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
16304748|NCT00613665|Biological|helicobacter pylori vaccine|Eight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly
16304749|NCT00613665|Biological|Placebo|Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly
16304750|NCT00613665|Biological|helicobacter pylori vaccine|Nine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
16304751|NCT00613665|Biological|helicobacter pylori vaccine|Ten subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
16304752|NCT00613652|Drug|AZD4877|10 mg IV (3 weeks treatment 1 week rest)
16304753|NCT00613626|Drug|Cisplatin|Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
16304754|NCT00613626|Drug|Etoposide|Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
16304755|NCT00613626|Drug|Placebo|Matched placebo oral daily
16304756|NCT00613626|Drug|ZD6474|ZD6474 100mg oral daily to be continued for the duration of the study.
16304757|NCT00613613|Drug|fenofibrate|Fenofibrate 145mg tablets once daily for 4 weeks
16304758|NCT00613613|Drug|fenofibrate|Fenofibrate 145mg tablets once daily for 4 weeks
16304759|NCT00613600|Dietary Supplement|Glucomannan|Two 665 mg capsules of glucomannan three times a day for 8 weeks
16304760|NCT00613600|Dietary Supplement|Inert microcrystalline cellulose|Two capsules of inert microcrystalline cellulose three times a day for eight weeks
16304761|NCT00613574|Drug|tiotropium-bromide|Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
16304762|NCT00613561|Drug|Fludarabine, Busulfan, and Anti-Thymocyte Globulin|Patients on this study will receive 5 days of Fludarabine, 1 day of Busulfan Test Dose, 2 Days of Busulfan Regimen Dose, and 4 days of Anti-Thymocyte Globulin
16304763|NCT00613548|Procedure|CABG alone|CABG alone
16304764|NCT00613548|Procedure|CABG + Mitral repair|CABG + Mitral repair
16304765|NCT00613535|Device|Mechanical debridement|Mechanical shaver will be used to remove large chondral flaps and loose fragments
16304766|NCT00613535|Device|Paragon T2|Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
16304767|NCT00613535|Procedure|Lavage debridement|Remove loose chondral fragments
16304768|NCT00613535|Device|Mechanical Debridement|Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
16304769|NCT00613535|Device|RF- based Debridement|Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.
16304770|NCT00613522|Other|polygraphic study|"Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.
~Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).
~Controls will be evaluated at 3 months using a phone interview"
16304771|NCT00613509|Biological|ALVAC(2) Melanoma multi-antigen therapeutic vaccine|0.5 mL, 2 cycles
16304772|NCT00613509|Biological|Intron A, Interferon alpha -2b|0.5 mL, 5 times per week for 4 weeks
16304773|NCT00613496|Drug|irbesartan|Irbesartan-tablet (150 mg) 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8 if no contraindication for up titration (investigator will decide on the basis of creatinin, urea and potassium after taking a blood sample) for 9 weeks.
16304774|NCT00613496|Drug|placebo|Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
16304775|NCT00613470|Drug|citalopram and escitalopram|"escitalopram tablets starting at 10 mg, increase to 20 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
~citalopram tablet or solution starting at 2o mg, increase to 40 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5."
16304776|NCT00613457|Drug|dexamethasone|10 mg/sqm/day from for 21 days
16304777|NCT00613457|Drug|asparaginase|native E-coli Asparaginase 5,000 IU/sqm x 8 doses
16304778|NCT00613457|Drug|Asparaginase|native E-Coli Asparaginase 10,000 IU/sqm x 4 doses
16304779|NCT00613457|Drug|cyclophosphamide|1,000 mg/sqm i.v. 2 doses in Induction phase 1000 mg/sqm i.v. 1 dose in Protocoll II 500 mg/sqm i.v. 1 dose in protocol III
16304780|NCT00613457|Drug|cytarabine|75 mg/sqm i.v.or s.c. 4 doses/week for 4 weeks in Induction phase 75 mg/sqm i.v.or s.c. 4 doses/week for 2 weeks in Protocol II and III
16304781|NCT00613457|Drug|daunorubicin|30 mg/sqm i.v. 4 doses in Induction phase
16304782|NCT00613457|Drug|doxorubicin|30 mg/sqm i.v. x 4 doses in Protocol II and III
16304783|NCT00613457|Drug|Etoposide|100 mg/sqm i.v. for 3 doses in HR block 3
16304784|NCT00613457|Drug|Ifosfamide|800 mg/sqm i.v.q12h x 5 in HR block 2
16304785|NCT00613457|Drug|mercaptopurine|60 mg/sqm p.o. c 28 days in Induction phase 60 mg/sqm p.o. x 56 days in Protocol M 50 mg/sqm daily in Maintenance phase
16304786|NCT00613457|Drug|Methotrexate|by age i.t. in Induction/Protocol M/Protocol II/Protocol III/HR Blocks and maintenance
16304787|NCT00613457|Drug|prednisone|60 mg/sqm daily p.o. for 28 days then tapered in Induction phase
16304788|NCT00613457|Drug|thioguanine|60 mg/sqm p.o. x 14 days in Protocol II and Protocol III
16304789|NCT00613457|Drug|Vincristine|1.5 mg/sqm i.v. x 4 doses in Induction phase and Protocol II 1.5 mg/sqm i.v. x 2 doses in Protocol III and HR block 1
16304790|NCT00613457|Drug|Vindesine|3 mg/sqm i.v. x 2 doses in HR block 2
16304895|NCT00612573|Drug|Doxycycline 2.4 mg/kg/day|doxycycline 160 mg/day, 12 weeks
16304896|NCT00612573|Drug|Placebo|Placebo, 12 weeks
16304897|NCT00612560|Drug|Anastrozole|1 mg per day
16304791|NCT00613444|Device|LumaCare LC-122M non-coherent light source|Subjects will receive a series of up to 6 treatment sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, light treatment parameters will be within the guidelines normally used clinically for red-light non-coherrent light sources, and thus fluences used will not exceed 75 J/cm2.
16304792|NCT00613431|Drug|CS8080|CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.
16304793|NCT00613431|Drug|Placebo|Some subjects will receive matching placebo instead of CS-8080.
16304794|NCT00613418|Device|IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System|Interwoven, self-expanding nitinol stent system, including delivery system and stent
16304795|NCT00613405|Other|Stress + cue exposure|Trier Social Stress Task(TSST): subject is asked to give a talk and perform a math task in front of an audience, follwed by neutral and marijuana cue exposure.
16304796|NCT00613405|Other|No stress + cue exposure|Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
16304797|NCT00613392|Dietary Supplement|powdered antioxidant|one vial mixed with water every day orally or through enteral tube
16304798|NCT00613392|Dietary Supplement|powdered cornstarch placebo|one vial mix with water and administer orally or via enteral tube
16304799|NCT00613379|Drug|PRO 140|10 mg/kg PRO 140, one IV dose (N=10)
16304800|NCT00613379|Drug|PRO 140|5 mg/kg PRO 140, one IV dose (N=10)
16304801|NCT00613379|Drug|Placebo|PBO, one IV dose (N=10)
16304802|NCT00613366|Drug|Misoprostol|Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
16304803|NCT00613366|Dietary Supplement|Magnesium Oxide|Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
16304804|NCT00613353|Other|Behavioral|Participants will be asked to wear an accelerometer
16304805|NCT00613340|Procedure|Cervical medial branch blocks|Cervical medial branch blocks done with 0.25 ml of local anesthetic and contrast
16304806|NCT00613340|Procedure|Cervical medial branch blocks|Cervical medial branch blocks with 0.5 ml of local anesthetic and contrast
16304807|NCT00613327|Drug|Oxybutynin chloride OROS|Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.
16304808|NCT00613288|Drug|Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo|"The trial is a double blinded, randomised cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young male participants will receive the GnRH-agonist leuprorelide 7,5 mg s.c. 3 weeks before examination on 3 occasions, and a fourth day without intervention.
~The four days will include treatment on the examination day, Day 1 with:
~Placebo (hypogonadism after leuprorelide injection)
~Testosterone gel 50 mg applicated in the morning at 06.00 am (physiologic substitution - after leuprorelide injection).
~Testosterone gel 150 mg applicated in the morning at 06.00 am (supra-physiologic substitution - after leuprorelide injection).
~No treatment."
16304809|NCT00613275|Other|patient Navigation|Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers
16304810|NCT00613262|Other|Narrow Band Imaging|Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
16304811|NCT00613249|Drug|Dapivirine Gel 4750, 0.05%, 2.5g|intravaginal gel, dosed daily
16304812|NCT00613249|Drug|Dapivirine Gel 4789, 0.05%, 2.5g|intravaginal gel, dosed daily
16304813|NCT00613249|Drug|HEC-based Placebo Gel|intravaginal gel, dosed daily
16304814|NCT00613223|Drug|Vandetanib and Etoposide|Vandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 100 mg/day for stratum 1 & 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at a flat dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle.
16304815|NCT00613197|Drug|Epanova|4g/day in divided doses
16304816|NCT00613184|Device|Nylon Flocked swab (Nasal secretion sampling)|Nasal Aspirate Nylon Flocked swab
16304817|NCT00613184|Device|Nylon Flocked swab (Nasal secretion sampling)|Nylon flocked swab Nasal Wash
16304818|NCT00613171|Drug|STI571|STI571 tablets taken orally once a day
16304819|NCT00613145|Drug|Capecitabine and Sorafenib|"During Cycle 1, patients will receive capecitabine alone for the first 7 days (Cohort A will receive 750 mg/m2 of capecitabine twice daily). For Days 8-14 of Cycle 1, patients will receive capecitabine (750 mg/m2 twice daily for Cohort A) combined with sorafenib (400 mg twice daily); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows:
~Cohort A will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 750 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle."
16304820|NCT00613145|Drug|Capecitabine and Sorafenib|During Cycle 1, patients will receive capecitabine alone for the first 7 days Cohort B will receive 1000 mg/m2 of capecitabine twice daily for the first 7 days of Cycle 1). For Days 8-14 of Cycle 1, patients will receive capecitabine (1000 mg/m2 twice daily for Cohort B) combined with sorafenib (400 mg twice daily for both cohorts); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows: Cohort B will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 1000 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle.
16304821|NCT00613132|Drug|Gleevec, RAD001, and Hydroxyurea|Dose of Gleevec will be 400 mg in 1st cohort & will be increased to 600 mg po/day & then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 & hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.
16304822|NCT00613106|Drug|HZT-501|Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
16304823|NCT00613106|Drug|Ibuprofen|Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
16304898|NCT00612560|Dietary Supplement|flaxseed|25 g per day ground
16304824|NCT00613093|Drug|Temodar and O6-Benzylguanine (BG)|"Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).
~BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle."
16304825|NCT00613080|Drug|capecitabine|1650 mg/m^2/day orally 5 days/week during radiotherapy.
16304826|NCT00613080|Drug|oxaliplatin|
16304827|NCT00613080|Procedure|resection|All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
16304828|NCT00613080|Radiation|radiation therapy|Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
16304829|NCT00613080|Drug|FOLFOX|"Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1.
~Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1."
16304830|NCT00613067|Drug|escitalopram|"Start with escitalopram 10mg
~According to patient's symptoms, stay on 10mg or increase up to 20mg
~Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages
~Length of washout period will be at least 2 weeks for any psychotropic drugs"
16304831|NCT00613054|Drug|Zactima, Gleevec, Hydroxyurea|"Pts will start treatment on day 1 of cycle 1 w Zactima, imatinib mesylate & hydroxyurea. All 3 agents administered in continuous daily, oral manner. Imatinib mesylate dose 400 mg/day for pts not on EIAEDs & 1000 mg/day for pts on EIAEDs based on previous studies demonstrating that pts on EIAEDs require significantly higher doses of imatinib mesylate & that such doses are safe & well tolerated. Dose of hydroxyurea 500 mg twice day. Dose level of Zactima will be increased in successive cohorts of pts as described below.
~Cohorts of 3-6 pts will accrue at each dose level until MTD is defined. Each cohort will consist of a mini of 3 newly enrolled pts. Intra-patient dose escalation is not permitted. Cohorts may be expanded at any dose level for further elaboration of safety & pharmacokinetic parameters as required.
~Treatment cycle is defined as daily administration of Zactima + imatinib mesylate & hydroxyurea for 28 days for purpose of scheduling evaluations."
16304832|NCT00613041|Procedure|CT Scan|All patients will undergo serial CT scans after 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months as is standard care. Nodules are to be scanned at 2.5mm collimation / 1.25 mm reconstruction. This resolution is necessary for volume measurements of nodules less than 1cm in diameter.
16304833|NCT00613028|Drug|Temo + Avastin|Patients have progressed/had gr3/> toxicity related to etoposide, with no had progression/gr 3/> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day.
16304834|NCT00613028|Drug|VP-16 + Avastin|Patients have progressed/had gr3/> toxicity related to temozolomide, but have not progressed/gr3/> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.
16304835|NCT00613015|Drug|Guanfacine|
16304836|NCT00613015|Drug|Modafinil|
16304837|NCT00613015|Drug|Placebo|
16304838|NCT00613002|Drug|testosterone gel|once daily transdermal testosterone gel, 300 mcg
16304839|NCT00613002|Drug|placebo gel|once daily transdermal placebo gel
16304840|NCT00612989|Drug|Temodar and O6-Benzylguanine|"O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses.
~Temodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG & then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle & every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days.
~Pts must fast for minimum of 1 hr prior to administration of each dose of Temodar & continue fasting 2 hrs after administration of each Temodar dose."
16304841|NCT00612963|Drug|Frio Oral Rinse|Prescription Mouth Rinse
16304842|NCT00612950|Drug|glucagon-like peptide-1,|GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
16304843|NCT00612950|Drug|glucose dependent insulinotropic polypeptide|continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
16304844|NCT00612950|Drug|Saline|continuous infusion of Saline for 120 min
16304845|NCT00612924|Device|Anaconda Stent Graft System|Endovascular device
16304846|NCT00612924|Device|Anaconda ONE-LOK Stent Graft System|Endovascular device
16304847|NCT00612911|Other|Cell therapy|bone marrow mononuclear cell
16304848|NCT00612898|Drug|apricitabine|800mg BID apricitabine orally for 48 weeks
16304849|NCT00612898|Drug|lamivudine|150mg BID lamivudine orally for 48 weeks
16304850|NCT00612872|Drug|[123I]CLINDE|Subjects will be injected with up to 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) of 123-I CLINDE followed by serial SPECT imaging.
16304851|NCT00612859|Drug|levetiracetam|
16304852|NCT00612846|Procedure|Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy|Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
16304853|NCT00612846|Procedure|Laparoscopic bile duct exploration during cholecystectomy|Laparoscopic bile duct exploration during cholecystectomy
16304854|NCT00612833|Procedure|Vasectomy occlusion techniques|Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
16304855|NCT00612820|Drug|GSK256066|200mcg bd,
16304856|NCT00612820|Drug|fluticasone propionate|200mcg od,100mcg bd
16304857|NCT00612807|Behavioral|Weekly marital therapy|Weekly marital therapy for 6 months.
16304899|NCT00612560|Drug|Placebo|Placebo pill 1 per day
16304858|NCT00612807|Drug|As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.|"Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002).
~SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine)
~SNRIs (e.g., venlafaxine)
~Bupropion SR (achieve dose of at least 150 mg BID)
~Mirtazapine
~Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl)
~Lithium augmentation
~MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)"
16304859|NCT00612794|Drug|exenatide once weekly|subcutaneous injection, once weekly
16304860|NCT00612794|Drug|placebo|subcutaneous injection, once weekly
16304861|NCT00612781|Procedure|cataract surgery (Hoya AF-1 [UY] YA-60BB)|implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens
16304862|NCT00612781|Procedure|cataract surgery (Hoya AF-1 [UV] VA-60BB lens)|implantation of an uncoloured Hoya AF-1 (UV) VA-60BB
16304863|NCT00612768|Biological|TRUE Test allergens Fragrance Mix and Thimerosol|"Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose
~Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone
~Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin
~Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin
~Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours."
16304864|NCT00612755|Drug|Peginterferon alfa-2a + ribavirin|Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
16304867|NCT00612729|Procedure|Polylens Y30 intraocular lens|cataract surgery
16304868|NCT00612729|Procedure|Orange Series Model PC 440 Y intraocular lens|cataract surgery
16304869|NCT00612716|Drug|busulfan|For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
16304870|NCT00612716|Drug|cyclophosphamide|Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
16304871|NCT00612716|Biological|Stem cell infusion|Infused on Day 0
16304872|NCT00612716|Radiation|Total body irradiation|165 cGy morning and evening on days -4 through -1.
16304873|NCT00612703|Drug|ARQ 197|Treatment with ARQ 197 in combination with erlotinib
16304874|NCT00612690|Behavioral|Community mental health consultation model program|The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning.
16304875|NCT00612690|Behavioral|Treatment as usual (TAU)|TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems.
16304876|NCT00612677|Drug|Oxaliplatin|Dose Regimen: 120 mg/m^2 on Days 1 every 21 days
16304877|NCT00612677|Drug|Pemetrexed|Dose Regimen: 500 mg/m^2 on Days 1 every 21 days
16304878|NCT00612664|Drug|Anti-CD137 (4-1BB) (BMS-663513)|IV solution, IV, until PD or toxicity
16304879|NCT00612651|Drug|Temodar and SCH 66336|2 separate strata accrued independently: Stratum 1-pts receiving CYP3A4-inducing anticonvulsants. Stratum 2-pts on non CYP3A4-inducing anticonvulsants or pts not on any anti-convulsants. Each strata treated & escalated independent of each other. Temozolomide administered orally at dose of 150 mg/m2 daily for 5 days, at bedtime, for 1st cycle & escalated to 200 mg/m2 daily for 5 days, at bedtime during subsequent cycles if tolerated. Treatment cycles repeated every 4wks following doses of Temozolomide from previous cycle. SCH 66336 administered orally twice daily, approximately every 12hrs. Except as specifically noted, pts advised to take capsules wh morning & evening meals, with approximately 240ml of non-carbonated water. Initial doses will be 125mg BID for stratum 1 & 75mg BID for stratum2. Treatment cycles repeated every 4 wks following dose of Temozolomide from previous cycle.
16304880|NCT00612638|Drug|Temodar, O6-BG, and Irinotecan|2 separate strata accrued independently: Stratum 1-pts receiving Dilantin, Tegretol or phenobarbital. Stratum 2-pts on anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any anti-convulsants. O6-BG administered intravenously 120mg/m2, over 1hr, prior to administration of Temozolomide on day 1 of 21day cycle. O6-BG administered intravenously 30mg/m2/day, over 48hrs, immediately after completion of CPT-11 infusion on day 1 of 21-day cycle. Temozolomide administered orally 355mg/m2 within 60 mins of end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3wks following dose of Temozolomide from previous cycle. CPT-11 administered intravenously in fasting state over 90mins. CPT-11 infusion will begin 1hr after Temozolomide administration. Initial doses 60mg/m2 for stratum 1 & 40mg/m2 for stratum2. Treatment cycles repeated every 3 wks following dose of CPT-11 from previous cycle.
16304881|NCT00612625|Drug|glucagon-like peptide-1|continuous infusion of GLP-1 (1½ pmol/kg/min)
16304882|NCT00612625|Drug|Saline|continuous infusion of saline
16304883|NCT00612612|Drug|obatoclax mesylate|Given IV
16304884|NCT00612612|Drug|fludarabine phosphate|Given IV
16304885|NCT00612612|Biological|rituximab|Given IV
16304886|NCT00612612|Other|laboratory biomarker analysis|Correlative study
16304887|NCT00612599|Drug|biphasic insulin aspart|
16304888|NCT00612586|Drug|Enzastaurin|1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease
16304889|NCT00612586|Drug|Placebo|oral, daily (up to 1 yr or until progressive disease)
16304890|NCT00612586|Drug|Leucovorin (LV)|400 milligram per meter squared (mg/m^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
16304891|NCT00612586|Drug|5-fluorouracil (5-FU)|400 mg/m^2 bolus then 2400 mg/m^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
16304892|NCT00612586|Drug|Bevacizumab (Bev)|5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
16304893|NCT00612573|Drug|Doxycycline 0.6 mg/kg/day|doxycycline 40 mg/day, oral, 12 weeks
16304894|NCT00612573|Drug|Doxycycline 1.2 mg/kg/day|doxycycline 80 mg/day, 12 weeks
16304900|NCT00612547|Drug|Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)|"Tablet:
~Children aged between 2 and 11 months: Artesunate 25 mg + Amodiaquine 67.5 mg et Children aged between 12 and 59 months: Artesunate 50 mg + Amodiaquine 135 mg Per os one intake per day/3 day"
16304901|NCT00612534|Drug|Sufentanil NanoTab|5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
16304902|NCT00612534|Drug|Placebo NanoTab|Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
16304903|NCT00612534|Drug|Sufentanil NanoTab|10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
16304904|NCT00612534|Drug|Sufentanil NanoTab|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
16304905|NCT00612521|Drug|Adenosine|For lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis.
16304906|NCT00612508|Drug|Desogen (ethinyl estradiol and desogestrel)|1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
16304907|NCT00612508|Drug|NuvaRing (ethinyl estradiol and etonogestrel)|Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
16304908|NCT00612495|Drug|oxaliplatin, 5 FU|"Oxaliplatin:130 mg/m² as a 2-hour intravenous (IV) infusion in 500 mL of 5% glucose solution on Day 1 and repeated every 3 weeks.
~5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 to Day 4, repeated every 3 weeks."
16304909|NCT00612482|Other|drug prevention curriculum|"Participants in the experimental arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes."
16304910|NCT00612469|Drug|Sodium Fluoride|Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
16304911|NCT00612469|Drug|vancomycin hydrochloride|Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
16304912|NCT00612469|Drug|vancomycin hydrochloride|Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
16304913|NCT00612469|Drug|chlorhexidine digluconate|Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
16304914|NCT00612456|Drug|Pazopanib|Pazopanib eye drops formulation
16304915|NCT00612443|Behavioral|Sham treatment|The sham/placebo treatment will consist of the RN graduate assistant standing near the table, slowly walking around from each side and to the foot of the table stopping periodically. The RN graduate assistant will be instructed to not focus on the patient in thought. While providing the placebo treatment the RN graduate assistant will mentally do multiplication equations. This serves as a distracter to keep the RN graduate assistant from setting intention or thoughts on the participant. At no time will the RN performing the placebo treatment move hands or arms over or around the participant or come in physical contact with the participant. The placebo treatment will be a minimum of 20 minutes but no greater than 30 minutes in length. A timer will be set in the treatment room to notify the practitioner of the time limit.
16304916|NCT00612443|Behavioral|Healing Touch|Behavioral: Healing Touch The Healing Touch intervention will consist of a brief meditative state in which the practitioners sets the intention of healing for the session. A hand scan to assess the biofield; consists of a technique of where the practitioner slowly moves her hands three to six inches above the body going from head to toe, to assess for any disturbances in the biofield; a non-contact Healing Touch treatment which will follow, to include a connection of the chakras. The chakras are connected by placing the hands above the body over each chakra, starting at the feet and progressing to the head. This will be followed by smoothing the biofield, achieved by the Practitioner slowly moving her hands above the body from the head and moving towards the feet (Hover-Kramer et al., 1996). At no time will the Practitioner make physical contact with the participant during the treatment. The treatment will be 20 minutes to 30 minutes in length.
16304917|NCT00612430|Drug|Bevacizumab and Etoposide|32 pts w recurrent WHO grade III MG & 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.
16304918|NCT00612417|Drug|Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402|Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
16304919|NCT00612391|Procedure|Lateral minimally invasive approach (plate fixation)|A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve.
16304920|NCT00612391|Procedure|Deltopectoral approach (plate fixation)|Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique.
16304991|NCT00611897|Drug|N-acetylcysteine and ketamine|Active drug (N-acetylcysteine)
16304921|NCT00612378|Device|GFX System|The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
16304923|NCT00612339|Drug|Avastin and Temozolomide|This is Phase II study with the combination of Avastin & Temozolomide for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to 4 cycles of Avastin & Temozolomide . Avastin administered at 10 mg/kg every 14 days beginning minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide will be dosed at 200 mg/m2 daily x 5 days in 28-day cycle. Patients will have baseline MRI & repeat MRI every 4 weeks. If there is no evidence of disease progression after each cycle, or unacceptable toxicity, or as determined by investigators, patient non-compliance or patient withdraws consent to continue therapy & requests discontinuation, patients will receive up to 4 cycles of Avastin & Temozolomide, then proceed with standard XRT therapy, & future therapy after 4 cycles will be at discretion of patient & treating physicians.
16304924|NCT00612326|Procedure|MRI and PET scanning procedures|a CT scan, MRI, and C-11 Acetate PET scan. All these scans will be done as an outpatient. After you finish these scans, your doctor will schedule you for surgery to remove your bladder and lymph nodes.
16304925|NCT00612313|Drug|Fluoxetine|Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
16304926|NCT00612313|Behavioral|Relapse prevention cognitive behavioral therapy (CBT)|After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.
16304927|NCT00612300|Behavioral|Lokomat - Physical therapy|A: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week
16304928|NCT00612300|Behavioral|Physical therapy - Lokomat|"B: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks.
~A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks."
16304929|NCT00612287|Drug|buprenorphine|Sublingual buprenorphine; product name Suboxone® (buprenorphine/naloxone). Dosing is informed by a clinical guideline which permits flexibility dependent up physician's clinical judgment. During the induction period (Day 1, at the physician's office) the first dose is 2 mg and can be brought up to 20 mg depending on patient's response. On Day 2 going forward dose can range from 2 mg q8h to 12 mg q8h. Rescue doses with buprenorphine are also permitted.
16304930|NCT00612274|Drug|tacrolimus|Tacrolimus will be administered at a dose of .02mg/kg/d IVCI beginning day -3 until able to take oral medicines reliably. Blood levels will be maintained at 5-10 ng/ml. The oral dose will be 4 times the IV dose. Tacrolimus will be converted to oral dosing prior to hospital discharge. Tacrolimus will be continued until 4 months post transplant (day +120) unless toxicity, refractory GVHD or the development of disease recurrence mandate discontinuation of the drug.
16304931|NCT00612274|Drug|Sirolimus|Sirolimus will be administered as a 12 mg oral loading dose on day -3 followed by 4mg daily. Sirolimus levels will be obtained on day +0 and then at least twice weekly to maintain a trough serum level of 3-12 ng/ml. Sirolimus will be continued until 5 months post transplant (day +150) unless toxicity, refractory GVHD or the development of disease recurrence mandate discontinuation of the drug.
16304932|NCT00612274|Drug|Methotrexate|Methotrexate, dose #1 will be administered on day +1 post transplantation, as an IV bolus, provided at least 24 hours have elapsed following infusion of donor stem cells at a dose of 10mg/m2. Dose #2 of Methotrexate will be administered 48 hours later, as IV bolus on day +3 at a dose of 5mg/m2.
16304933|NCT00612261|Procedure|Arteriovenous Crossing Sheathotomy|In each sheathotomy patient, a standard pars plana vitrectomy is performed, followed by surgical separation of the posterior cortical vitreous from the optic nerve and posterior retina. After the relevant arteriovenous crossing site is identified based on preoperative FA, a bent microvitreoretinal blade is used to open the internal limiting membrane and the nerve fiber layer over the artery, with the incision commencing 100-200 micrometer proximal to the AV crossing. The incision is continued parallel to and under the retinal arteriole, with a gentle lifting motion, until the common AV crossing sheath is encountered and incised in a side-to-side manner. The completion of AV dissection is confirmed by an elevation of the overlying artery.
16304934|NCT00612261|Procedure|Intravitreal Triamcinolone Acetonide Injection|The IVTA group receive intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (40 mg/mL; Tamceton®; Hanall Pharmaceutical, Seoul, Korea). The injections are performed using 0.5% proparacaine drops (Alcaine®; Alcon Laboratories, Fort Worth, TX) for topical anesthesia under sterile conditions. The drug is injected through the inferotemporal pars plana using a 30-gauge needle. The correct intravitreal localization of the suspension, and perfusion of the optic nerve head, are then confirmed by indirect ophthalmoscopy.
16304935|NCT00612248|Other|Splint|Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations
16304936|NCT00612235|Drug|Lamotrigine|Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
16304937|NCT00612235|Drug|Levetiracetam|Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
16304938|NCT00612235|Drug|Carbamazepine|Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.
16304939|NCT00612235|Other|No Intervention|No intervention was given
16304940|NCT00612222|Biological|autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes|ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
16304941|NCT00612222|Biological|ALVAC MART-1 Vaccine|ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.
16304992|NCT00611897|Drug|placebo and ketamine|placebo N-acetylcysteine
16304942|NCT00612222|Biological|aldesleukin|Aldesleukin - 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)
16304943|NCT00612222|Drug|cyclophosphamide|60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour
16304944|NCT00612222|Drug|fludarabine phosphate|25 mg/m^2 day intravenous piggy back over 30 minutes for 5 days
16304945|NCT00612209|Drug|ARQ 197|Treatment with ARQ 197
16304946|NCT00612196|Drug|TB-402|Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
16304947|NCT00612196|Drug|Placebo|
16304948|NCT00612183|Drug|bendamustine hydrochloride|bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.
16304949|NCT00612170|Drug|[S,S]-Reboxetine|10 mg oral tablet once a day dosing
16304950|NCT00612170|Drug|Placebo|0 mg oral tablet once a day dosing
16304951|NCT00612170|Drug|[S,S]-Reboxetine|4 mg oral tablet once a day dosing
16304952|NCT00612170|Drug|[S,S]-Reboxetine|8 mg oral tablet once a day dosing
16304953|NCT00612157|Drug|Eszopiclone|Eszopiclone 3mg orally at bedtime for 14 nights
16304954|NCT00612157|Drug|Placebo control|Matching placebo
16304955|NCT00612144|Drug|Glimepiride/metformin fixed combination|"Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks
~Maintenance dose for 10 weeks after 2~14 weeks of dose titration
~Dose titration according to titration algorithm based on daily mean SMBG"
16304956|NCT00612144|Drug|Metformin HCl|"Metformin HCl 500mg~1250mg bid for 12~26 weeks
~Maintenance dose for 10 weeks after 2~14 weeks of dose titration
~Dose titration according to titration algorithm based on daily mean SMBG"
16304957|NCT00612118|Drug|GSK256066|200mcg bd
16304958|NCT00612118|Drug|azelastine hydrochloride|140mcg
16304959|NCT00612105|Drug|Retigabine|150mg/day up to 900mg/day
16304960|NCT00612105|Drug|Placebo|daily
16304961|NCT00612092|Radiation|Spiral image acquisition|standard spiral scan protocol
16304962|NCT00612092|Radiation|sequential image acquisition|sequential CT scan protocol
16304963|NCT00612079|Drug|Sertindole|oral 3 x 4mg
16304964|NCT00612079|Drug|Placebo|3 x 4mg Placebo
16304965|NCT00612066|Drug|rosiglitazone maleate|
16304966|NCT00612040|Drug|insulin degludec|Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
16304967|NCT00612040|Drug|insulin degludec|Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
16304968|NCT00612040|Drug|insulin glargine|Treat-to-target dose titration scheme, injection s.c., once daily
16304969|NCT00612040|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
16304970|NCT00612014|Drug|5% dextrose in water|60 ml IV infusion over 30 minutes
16304971|NCT00612014|Drug|TZP-101|"40 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
16304972|NCT00612014|Drug|TZP-101|"80 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
16304973|NCT00612014|Drug|TZP-101|"160 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
16304974|NCT00612014|Drug|TZP-101|"320 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
16304975|NCT00612014|Drug|TZP-101|"600 micrograms/kg iv 2ml/minute for 30 minutes
~1 infusion/day for 4 consecutive days"
16304976|NCT00612001|Biological|glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine|
16304977|NCT00611988|Behavioral|Self-managed walking|The intervention includes individual therapy, group reinforcement, and follow-up phone contact
16304978|NCT00611988|Other|Control group|Attention control group will receive routine follow-up phone calls
16304979|NCT00611975|Drug|Fluoxetine|Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.
16304980|NCT00611975|Drug|Bupropion|Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
16304981|NCT00611962|Drug|Oxaliplatin, Paclitaxel|"Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient
~Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL."
16304982|NCT00611949|Other|Geranium oil|2 applications of topical oil per week for 2 weeks
16304983|NCT00611936|Drug|Placebo|Placebo
16304984|NCT00611936|Drug|Atomoxetine|20mg maximum of d-amphetamine
16304985|NCT00611923|Drug|Flutamide|Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
16304986|NCT00611923|Drug|Placebo|Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
16304987|NCT00611910|Device|sirolimus-eluting stent|due to randomization Cypher stent will be implanted
16304988|NCT00611910|Device|paclitaxel-eluting stent|due to randomization Taxus stent will be implanted
16304989|NCT00611910|Device|biodegradable-polymer-based sirolimus-eluting stent|due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
16304990|NCT00611910|Device|bare metal stents|Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist
16304993|NCT00611884|Drug|insulin glargine|Treat-to-target dose titration scheme, s.c. injection.
16304994|NCT00611884|Drug|insulin degludec|Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
16304995|NCT00611884|Drug|insulin degludec|Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
16304996|NCT00611884|Drug|insulin degludec|Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
16304997|NCT00611884|Drug|metformin|Tablets, 1500-2000 mg/day
16304998|NCT00611871|Drug|Propranolol|40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
16304999|NCT00611871|Drug|Placebo|40mg placebo, followed 2 hrs after with 60mg placebo
16305000|NCT00611858|Drug|Cetuximab|
16305001|NCT00611858|Drug|5-Fluorouracil|
16305002|NCT00611858|Radiation|Radiation|
16305003|NCT00611845|Drug|Aprotinin (Trasylol, BAYA0128)|Trasylol at either 1,000,000 KIU or 2,000,000 KIU
16305004|NCT00611832|Behavioral|"Triple P Media Series -- Standard Information-Only version"|10 episodes, 12 minutes per episode, 2 episodes viewed per week for a total of 5 weeks. Demonstrates parenting practices for effectively handling a range of difficult child behaviors.
16305005|NCT00611832|Behavioral|"Triple P Media Series -- Enhanced Behavior Activation version"|10 episodes, 12 minutes per episode, 2 episodes viewed per week for a total of 5 weeks. Demonstrates parenting practices for effectively handling a range of difficult child behaviors; includes specific content elements designed to promote parents' adoption of the targeted parenting skills
16305006|NCT00611819|Drug|Peg interferon + Ribavirin|Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
16305007|NCT00611819|Drug|Peg interferon + Ribavirin|Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
16305008|NCT00611806|Dietary Supplement|Folic Acid|Folic acid 2mg po daily
16305009|NCT00611806|Dietary Supplement|B12|B12 400 micrograms po daily
16305010|NCT00611806|Other|Placebo|1 capsule po daily
16305011|NCT00611793|Drug|PTK787/ZK222584 and Bevacizumab|PTK787/ZK222584 will be administered as a single agent orally on days 1-14 of cycle 1. The day 14 dose of PTK787/ZK222584 will be administered in the outpatient clinic and PK samples will be obtained. On Day 15 the patient will receive the initial dose of IV bevacizumab and PTK787/ZK222584. Bevacizumab will be repeated at 2 week intervals in patients with stable disease or better for four cycles of treatment (16 weeks). After four treatment cycles, only patients with a PR or CR will continue treatment with PTK787/ZK222584 and bevacizumab. Patients with stable disease may continue single agent PTK787/ZK22258 from cycle 5 onward. Protocol treatment will continue until disease progression or intolerable toxicity warrants drug discontinuation.
16305012|NCT00611780|Radiation|tube voltage|standard 120 kV
16305013|NCT00611780|Radiation|tube voltage|reduced voltage of 100 kV
16305014|NCT00611767|Drug|Thiopental|A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
16305015|NCT00611767|Drug|Placebo|A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
16305016|NCT00611754|Drug|Oxaliplatin, 5-FU|Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs.
16305017|NCT00611741|Drug|furosemide, Na supplements|furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days
16305018|NCT00611728|Drug|SU011248 & Irinotecan|"Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 & 1/2 hrs on 1st day of each cycle & then again on days 14 & 28.
~Sutent is approved for adult subjects w some forms of kidney cancer. It is considered investigational for brain tumors. Dosing will begin on day 1 of cycle 1 & continue daily for 4 wks by mouth.
~Irinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered investigational for brain tumors. Irinotecan dose will depend on your height & weight. Irinotecan will be given intravenously over 90 min on days 1, 14 & 28 of 6wk cycle.
~You will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, & then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, & then within 1 week prior to completion of every other cycle."
16305019|NCT00611715|Drug|erlotinib hydrochloride|OSI-774 150 mg/day
16305020|NCT00611715|Drug|letrozole|Letrozole 2.5 mg/day
16305021|NCT00611715|Genetic|fluorescence in situ hybridization|To determine HER2 gene amplification or excess copies of the HER2 gene
16305022|NCT00611715|Other|immunohistochemistry staining method|to measure the epidermal growth factor receptors (EGFR)
16305023|NCT00611715|Other|laboratory biomarker analysis|To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
16305024|NCT00611702|Procedure|Kidney biopsy|Kidney biopsy (recipients only) will be obtained for RT-PCR, microarray analyses and histology.
16305025|NCT00611689|Drug|Imatinib and PTK/ZK222584|Imatinib and PTK/ZK will each be administered orally daily. Two dose levels of imatinib (400 mg and 600 mg) will be tested with 4 dose levels of PTK/ZK (250 mg, 500 mg, 750 mg, and 1000 mg). 3 patients will be accrued at each individual dose level. If dose-limiting toxicities are reported in ≤ 1/3 patients, the dose level will be expanded to 6 patients. If dose-limiting toxicities are reported in < 2/6 patients, then dose escalation will continue. If ≥ 2/6 patients experience dose-limiting toxicity, the next lower dose will be considered the maximum tolerated dose and will be expanded to a total of 12 patients. There will be no intrapatient dose escalations. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered.
16305026|NCT00611676|Drug|Venlafaxine|Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.
16305027|NCT00611663|Biological|Prevenar® and Pneumo23®|Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)
16305028|NCT00611663|Biological|Placebo, Pneumo23®|Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24
16305029|NCT00611650|Drug|defined green tea catechin extract|Given orally
16305031|NCT00611637|Biological|CMV pp65 Specific T Cells|Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.
16305032|NCT00611624|Radiation|Mammosite brachytherapy radiation|Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.
16305033|NCT00611611|Biological|fluzone|once
16305034|NCT00611611|Biological|pneumovax|once
16305035|NCT00611598|Other|Blood draw and Questionnaires|Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
16305036|NCT00611598|Other|Blood draw and Questionnaires|Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
16305037|NCT00611585|Device|Birmingham Hip Resurfacing|Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
16305038|NCT00611572|Drug|iomazenil|Given as IV infusion
16305039|NCT00611572|Drug|iomazenil|saline IV infusion
16305040|NCT00611559|Biological|Infanrix™ penta|Subjects received a booster dose
16305041|NCT00611559|Biological|Infanrix™ hexa|Subjects received a booster dose
16305042|NCT00611546|Other|Photo-protection|Parenteral solutions are protected from day light using aluminum covers
16305043|NCT00611546|Other|Photo-exposure|Perenteral nutrition bottles and tubings are allowed to be exposed to day light.
16305044|NCT00611533|Drug|atomoxetine|Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
16305045|NCT00611533|Drug|placebo|Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
16305046|NCT00611507|Drug|Oxaliplatin, 5-Fluorouracil|5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.
16305047|NCT00611494|Drug|MMF|Gradual optimization of drug dosage, as clinically tolerated.
16305048|NCT00611494|Drug|EC-MPS|Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
16305049|NCT00611481|Behavioral|Tai Chi|a set of pre-designed Tai Chi Movements
16305050|NCT00611481|Behavioral|Strength training|Lower-extremity strength training exercises
16305051|NCT00611481|Behavioral|Low-Impact Exercise Control|a set of chair-based low-impact exercises
16305052|NCT00611468|Drug|Topotecan|All subjects receive treatment with intravenous topotecan and oral erlotinib.
16305053|NCT00611468|Drug|Erlotinib|All subjects receive treatment with intravenous topotecan and oral erlotinib.
16305054|NCT00611455|Drug|ofatumumab|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period
16305055|NCT00611455|Drug|Placebo|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
16305056|NCT00611442|Drug|lubiprostone|lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
16305057|NCT00611442|Drug|placebo|placebo gelcap, taken at noon the day prior to the colonoscopy
16305058|NCT00611429|Behavioral|Counseling sessions|The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.
16305059|NCT00611429|Behavioral|Group workshop|During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.
16305060|NCT00611416|Dietary Supplement|green tea|different catechin combinations
16305061|NCT00611416|Dietary Supplement|Mix of catechins and caffeine|3 tablet a day
16305062|NCT00611416|Dietary Supplement|EGCG|3 tablets a day
16305063|NCT00611416|Dietary Supplement|EGC|3 tablets a day
16305064|NCT00611416|Dietary Supplement|Caffeine|3 tablets a day
16305065|NCT00611416|Dietary Supplement|Placebo|3 tablets a day
16305066|NCT00611403|Drug|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)|Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
16305067|NCT00611403|Drug|Artificial Tears REFRESH ENDURA®|REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
16305068|NCT00611390|Dietary Supplement|mixture of aromatic essential oils.|3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.
16305069|NCT00611390|Dietary Supplement|placebo|0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.
16305070|NCT00611364|Other|Physical Therapy and education meetings|Physical therapy was realized three two times per week and education meeting every fifteen days
16305071|NCT00611364|Other|education meetings|This group only participed of education meeting (every fifteen days)
16305072|NCT00611351|Biological|anti-thymocyte globulin|
16305073|NCT00611351|Drug|busulfan|
16305074|NCT00611351|Drug|cyclophosphamide|
16305075|NCT00611351|Drug|mycophenolate mofetil|
16305076|NCT00611351|Drug|tacrolimus|
16305077|NCT00611351|Genetic|polymerase chain reaction|
16305078|NCT00611351|Genetic|polymorphism analysis|
16305079|NCT00611351|Other|flow cytometry|
16305080|NCT00611351|Other|laboratory biomarker analysis|
16305081|NCT00611351|Other|pharmacogenomic studies|
16305082|NCT00611351|Other|pharmacological study|
16305083|NCT00611351|Procedure|allogeneic bone marrow transplantation|
16305084|NCT00611351|Procedure|allogeneic hematopoietic stem cell transplantation|
16305085|NCT00611351|Procedure|peripheral blood stem cell transplantation|
16305086|NCT00611338|Behavioral|HIV Skills-based Prevention|
16305087|NCT00611325|Drug|Avastin|Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.
16305088|NCT00611325|Drug|Bortezomib|Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs & 2.5 mg/m2 for patients taking EIAEDs.
16305089|NCT00611312|Behavioral|Cognitive Training|Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day
16305090|NCT00611299|Dietary Supplement|BB-12 and CRL 431|
16305091|NCT00611286|Drug|clopidogrel treatment after bare metal stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent
16305092|NCT00611286|Drug|clopidogrel treatment after bare metal stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.
16305093|NCT00611286|Drug|clopidogrel after zotarolimus-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation
16305094|NCT00611286|Drug|clopidogrel after paclitaxel-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent
16305095|NCT00611286|Drug|clopidogrel after everolimus-eluting stent implantation|extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent
16305096|NCT00611286|Drug|clopidogrel after zotarolimus-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
16305097|NCT00611286|Drug|clopidogrel after paclitaxel-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
16305098|NCT00611286|Drug|clopidogrel after everolimus-eluting stent implantation|Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
16305099|NCT00611273|Device|GFX|The GFX system employs minimally invasive technique utilizing Bi-polar (radio frequency) RF technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
16305100|NCT00611260|Behavioral|Vipassana Meditation practice and instruction|2-3 instructed meditation sessions per week in addition to standard medical care.
16305101|NCT00611260|Other|Standard Medical Care|Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.
16305102|NCT00611247|Drug|Temozolomide|"Priming, Group 2 only, 100 mg/m2/day temozolomide.
~Induction (both arms) 200 mg/m2/day temozolomide"
16305103|NCT00611221|Procedure|Massage|Massage therapy by an RMT during labour
16305104|NCT00611221|Procedure|Massage|Massage by anyone else, eg. husband, nurse, doula
16305105|NCT00611208|Biological|A-dmDT390-bisFv(UCHT1)|A-dmDT390-bisFv(UCHT1) will be administered as 60 μg/kg total given as 7.5 μg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes
16305106|NCT00611195|Drug|propofol, remifentanil|propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
16305107|NCT00611169|Drug|tirofiban|tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
16305108|NCT00611156|Dietary Supplement|ginger|added to a brunch meal
16305109|NCT00611156|Dietary Supplement|black pepper|Added to a brunch meal
16305110|NCT00611156|Dietary Supplement|horseradish|Added to a brunch meal
16305111|NCT00611156|Dietary Supplement|mustard|Added to a brunch meal
16305112|NCT00611156|Dietary Supplement|placebo|Added to a bruch meal
16305113|NCT00611143|Drug|atorvastatin|atorvastatin 20 mg/d, started 3 days before surgery
16305114|NCT00611130|Drug|vigabatrin|Tablets twice a day for 9 weeks
16305115|NCT00611130|Drug|placebo|tablets twice daily for 9 weeks
16305116|NCT00611117|Other|Physical Activity Level|High vs. low physical activity during a high fat diet consumption.
16305117|NCT00611104|Dietary Supplement|standardized freeze-dried table grape powder|
16305118|NCT00611104|Other|laboratory biomarker analysis|
16305119|NCT00611104|Other|pharmacological study|
16305120|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|Follow-up appointment needs/plans
16305121|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|Laboratory follow-up needs
16305122|NCT00611091|Other|Electronic delivery of enhanced discharge information to the ambulatory physician|New medications
16305123|NCT00611065|Device|magnetic resonance imaging|MR contrast agent (0.1 mmol/kg)
16305124|NCT00611052|Behavioral|the Adolescent Coping with Stress|A group cognitive intervention, manualized and highly structured. Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention. Groups leaders are specifically trained for this course.
16305125|NCT00611052|Behavioral|Treatment as usual|The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
16305126|NCT00611052|Other|usual health education|usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale
16305127|NCT00611039|Drug|Darunavir 900mg + ritonavir 100 mg once a day|Darunavir 900mg + ritonavir 100 mg once a day
16305128|NCT00611039|Drug|Darunavir 600mg + ritonavir 100mg twice day|Darunavir 600mg + ritonavir 100mg twice day
16305129|NCT00611026|Drug|Tolterodine ER|The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
16305130|NCT00611026|Drug|Placebo|Placebo treatment will be once daily(QD) for 12 weeks.
16305576|NCT00607932|Procedure|adjuvant therapy|
16305131|NCT00611026|Drug|Fesoterodine|The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
16305132|NCT00611013|Device|Magnetic Resonance Imaging|Some participants may receive MRI contrast agent, 0.1 mmol/kg
16305133|NCT00611000|Dietary Supplement|folic acid|
16305134|NCT00611000|Genetic|DNA methylation analysis|
16305135|NCT00611000|Genetic|gene expression analysis|
16305136|NCT00611000|Genetic|microarray analysis|
16305137|NCT00611000|Genetic|polymorphism analysis|
16305138|NCT00611000|Other|laboratory biomarker analysis|
16305139|NCT00610987|Drug|cefazolin|Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.
16305140|NCT00610987|Drug|Placebo|Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo.
16305141|NCT00610974|Behavioral|Body-weight supported treadmill training|BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
16305142|NCT00610974|Behavioral|Body-weight supported treadmill training|BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
16305143|NCT00610948|Biological|panitumumab|Given IV
16305144|NCT00610948|Drug|everolimus|Given orally
16305145|NCT00610948|Drug|fluorouracil|Given IV
16305146|NCT00610948|Drug|leucovorin calcium|Given IV
16305147|NCT00610948|Drug|oxaliplatin|Given IV
16305148|NCT00610935|Drug|Peramivir|To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
16305149|NCT00610935|Drug|Placebo|Single intramuscular injection
16305150|NCT00610922|Dietary Supplement|Docosahexaenoic acid (DHA)|DHA 20 mg per day through 12 months of life
16305151|NCT00610909|Drug|Paroxetine CR|Those in the active treatment group will receive doses of Paxil CR in increments of 12.5 mg daily for the first week and increased at 12.5 mg increments at visit weeks to a maximum of 50 mg daily, as determined by the investigator. The investigator will adjust dosage based on clinical response. Following the completion of the double-blind phase, patients on placebo and non-responders to the study drug will be tapered off the study drug back to 0 over 2 weeks, and they will be referred to their Primary Care Physician, Internist or Gastroenterologist to be prescribed treatment for Irritable Bowel Syndrome.
16305152|NCT00610909|Drug|Placebo|Placebo
16305153|NCT00610883|Drug|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU|LSA4 intervention includes three phases: induction, consolidation and maintenance
16305154|NCT00610870|Drug|atorvastatin|atorvastatin 80mg/day before primary coronary intervention
16305155|NCT00610857|Drug|Anti-CTLA4 monoclonal antibody and HDI|"One course of therapy consists of three cycles (1 cycle=28days). Anti-CTLA4 monoclonal antibody (15 mg/kg i.v.) will be given during the first cycle only. HDI will be given all three cycles - cycle 1: 20 MU/m2 i.v. on days 0, 1, 2, 3, 4 a week (MTWRF) for 4 weeks; cycle 2: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks; and cycle 3: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks.
~Response assessment will be carried out at day 56 and day 84. Every patient will receive 3 cycles regardless of response status after the first 2 cycles. However, a patient may be taken off therapy in the event of clinical progression at the discretion of the treating physician.
~Patients without evidence for disease progression after 3 cycles may be offered additional cycles two weeks after completion of the third cycle. Therapy will continue for a maximum of 12 months."
16305156|NCT00610844|Procedure|pulmonary radiofrequency ablation|CT-guided pulmonary radiofrequency ablation
16305157|NCT00610831|Device|DIRECTVIEW CR Mammography|4 views screening mammogram
16305158|NCT00610818|Other|Palifermin|day -14, -13, -12 before transplant and then day 0,1,2 after transplant
16305159|NCT00610805|Other|Preventive Cardiology|Patients will receive those interventions recommended by the Preventive Cardiologist. This may include: exercise, electrocardiogram, specialized blood testing, blood pressure monitoring, nutrition counseling, smoking cessation counseling, and pharmacotherapy for hypercholesterolemia, hypertension, and blood sugar abnormalities.
16305160|NCT00610805|Other|Usual Care|Participants will receive usual care per their primary care physician.
16305161|NCT00610792|Drug|bortezomib|1.3 mg/m2 on Days 1, 4, 8 & 11 every 3 weeks (1 cycle = 21 days) for up to six cycles
16305162|NCT00610792|Drug|pegylated liposomal doxorubicin|30 mg/m2 on Day 1 every 3 weeks (1 cycle = 21 days) for up to six cycles
16305163|NCT00610779|Dietary Supplement|mixture of aromatic essential oils.|1% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the nose.
16305164|NCT00610779|Dietary Supplement|placebo|0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
16305165|NCT00610753|Behavioral|Family Behavior Therapy|This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues.
16305213|NCT00610480|Drug|1st visit Systane, then 2nd visit Optive|"First visit: Instillation of Systane followed by evaporometry assessment after 30 minutes.
~Second visit: Instillation of Optive followed by evaporometry assessment after 30 minutes."
16305670|NCT00607113|Drug|RAD001|10 mg By Mouth Daily For 21 Days
16305166|NCT00610753|Behavioral|Systems Family Therapy|This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change.
16305167|NCT00610740|Drug|topical gemcitabine hydrochloride|Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
16305168|NCT00610740|Procedure|therapeutic conventional surgery|hysterectomy
16305169|NCT00610727|Drug|Prochlorperazine 0.5 mg IV over 5 sec|IV Prochlorperazine for bioavailability
16305170|NCT00610727|Drug|Inhaled prochlorperazine 0.625 mg|Inhaled Staccato Prochlorperazine 0.625 mg
16305171|NCT00610727|Drug|Inhaled prochlorperazine 1.25 mg|Inhaled Staccato Prochlorperazine 1.25 mg
16305172|NCT00610727|Drug|Inhaled prochlorperazine 2.5 mg|Inhaled Staccato Prochlorperazine 2.5 mg
16305173|NCT00610727|Drug|Inhaled prochlorperazine 5 mg|InhaledStaccato Prochlorperazine 5 mg
16305174|NCT00610727|Drug|Inhaled prochlorperazine 10 mg|InhaledStaccato Prochlorperazine 10 mg
16305175|NCT00610727|Drug|Inhaled placebo|Inhaled Staccato Placebo (0 mg)
16305176|NCT00610727|Drug|Prochlorperazine 10 mg IV over 5 sec|Prochlorperazine 10 mg IV over 5 sec for patient qualification
16305177|NCT00610714|Drug|AZD0530|oral once daily dose
16305178|NCT00610714|Drug|Carboplatin|intravenous injection
16305179|NCT00610714|Drug|Paclitaxel|intravenous infusion
16305180|NCT00610701|Device|Anterior pin placement|Anteriorly-placed (front of the leg) femoral external fixator pins
16305181|NCT00610701|Device|Lateral pin placement|Laterally-placed (side of the leg) femoral external fixator pind
16305185|NCT00610675|Drug|Org 50081|One tablet daily
16305186|NCT00610649|Drug|MK-8777|Orally administered capsules containing either 50 mg or 100 mg MK-8777.
16305187|NCT00610649|Drug|Placebo|Orally administered matching placebo capsules.
16305188|NCT00610636|Procedure|Hepatic resection|Hepatic resection
16305189|NCT00610623|Drug|azithromycin|300 mg/day, IV from day 1 to 20
16305190|NCT00610623|Drug|placebo|once per day, IV from day 1 to 20
16305191|NCT00610610|Drug|Paroxetine CR|Those in the active treatment group will receive doses of Paxil CR in the following manner: week 1: 12.5 mg per day, week 2: 25 mg per day, week 3: 37.5 mg per day, wk 4: 50 mg per day and week 5: 62.5 mg per day.
16305192|NCT00610610|Drug|Placebo|Same shape Placebo
16305193|NCT00610584|Procedure|acupuncture|arm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
16305194|NCT00610584|Procedure|minimal (sham)acupuncture|arm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
16305195|NCT00610584|Drug|cetirizine dihydrochloride (rescue medication)|arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone
16305196|NCT00610571|Drug|Oral Topotecan and Temodar|"Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.
~Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose."
16305197|NCT00610558|Device|Arm 1: Juvenile Myoclonic Epilepsy|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
16305198|NCT00610558|Device|Arm 2: Frontal Lobe Epilepsy|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
16305199|NCT00610558|Device|Arm 3: Normal Controls|Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
16305200|NCT00610545|Drug|Atorvastatin|Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
16305201|NCT00610545|Drug|Atorvastatin|Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
16305202|NCT00610532|Drug|phenytoin|intravenous phenytoin (15 mg/kg) single dose
16305203|NCT00610532|Drug|phenytoin and probenecid|intravenous phenytoin (15 mg/kg) single dose and oral probenecid 2000 mg single dose
16305204|NCT00610519|Dietary Supplement|mixture of aromatic essential oils.|3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the throat.
16305205|NCT00610519|Dietary Supplement|placebo|0:1% of Lemon VIP (Florasynth,Israel), spraying to the throat.
16305206|NCT00610506|Drug|Escitalopram|Escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability.
16305207|NCT00610493|Drug|Bevacizumab|5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle
16305208|NCT00610493|Drug|Temsirolimus|5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle
16305209|NCT00610493|Procedure|Additional Blood Drawn|2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.
16305210|NCT00610493|Procedure|Biopsy|First tumor biopsy during screening visit and Second at the end of Cycle 1
16305211|NCT00610493|Procedure|DCE-MRI Scan|DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1
16305212|NCT00610480|Drug|1st visit Optive, then 2nd visit Systane|"First visit: Instillation of Optive followed by evaporometry assessment after 30 minutes.
~Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes."
16305716|NCT00606697|Drug|GR205171|10 milligrams (mg)
16305214|NCT00610467|Device|Disease Group|Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
16305215|NCT00610467|Device|Control Group|Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
16305216|NCT00610454|Drug|Levetiracetam|
16305217|NCT00610441|Drug|MK-8777|
16305218|NCT00610441|Drug|Placebo|
16305219|NCT00610428|Drug|Staccato Placebo|Inhaled Staccato Placebo
16305220|NCT00610428|Drug|Staccato Prochlorperazine 5 mg|Inhaled Prochlorperazine 5 mg
16305221|NCT00610428|Drug|Staccato Prochlorperazine 10 mg|Inhaled Prochlorperazine10 mg
16305222|NCT00610415|Procedure|tumor biopsy|
16305223|NCT00610402|Other|blood sample tear drop sample|blood sample tear drop sample
16305224|NCT00610389|Biological|immunotherapy with dendritic cells|We will administer four daily doses (repeated every 24 hours)o dendritic cells in two cycles one month apart. We will administer systemic treatment with PEG-IFN alfa and GM-CSF to potentiate activity.
16305225|NCT00610376|Behavioral|Preschool handwashing intervention program|This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
16305226|NCT00610376|Behavioral|Home component intervention|The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.
16305227|NCT00610363|Biological|Rilonacept|Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
16305228|NCT00610363|Other|Placebo (for Rilonacept)|Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
16305229|NCT00610350|Drug|levosimendan|24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
16305230|NCT00610350|Drug|Placebo|an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
16305231|NCT00610337|Drug|Cethrin® (BA-210)|Intraoperative epidural administration during spinal decompression surgery
16305232|NCT00610337|Procedure|placebo|Spinal decompression surgery without administration of Cethrin® BA-210
16305233|NCT00610324|Drug|Chlorhexidine gluconate|Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
16305234|NCT00610324|Drug|Potassium permanganate|Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
16305235|NCT00610311|Drug|cyclophosphamide|60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour
16305236|NCT00610311|Drug|fludarabine phosphate|25 mg/m^2 day intravenous piggy back over 30 minutes for 5 days
16305237|NCT00610311|Biological|Aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.
16305238|NCT00610311|Biological|ALVAC gp100 Vaccine|0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL)
16305239|NCT00610311|Biological|anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL)|3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.
16305240|NCT00610298|Device|whole body vibration using a Galileo vibrating platform|whole body vibration at 20 hertz for 3 minutes 3 to 5 days per week for up to 12 weeks
16305241|NCT00610285|Other|Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)|Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.
16305242|NCT00610272|Radiation|Radiotherapy|4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
16305243|NCT00610272|Radiation|Radiotherapy|8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
16305244|NCT00610272|Radiation|Radiotherapy|8 Gy in a single fraction; retreatments > 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);
16305245|NCT00610272|Radiation|Radiotherapy|12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments > 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;
16305246|NCT00610259|Behavioral|brief behavioral therapy for insomnia (bBT-I)|4 50-minute individual sessions every week for 4 weeks
16305247|NCT00610259|Other|Treatment as usual (TAU)|The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
16305248|NCT00610246|Drug|Sorafenib|Sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. Dose level 1 is 200mg of sorafenib. If full oral dose (400mg orally, twice a day) is reached in a given cohort then an additional dose level will open where sorafenib treatment is extended following radiation for a total of eight weeks.
16305249|NCT00610233|Procedure|deep brain stimulation ON|deep brain stimulation in the ON state
16305250|NCT00610233|Procedure|Deep brain stimulation OFF|Urodynamic investigation with deep brain stimulation in the OFF state
16305251|NCT00610220|Device|Fiberglass short arm cast|Cast will be applied for a 4-week period
16305252|NCT00610220|Device|Prefabricated wrist splint|Splint will be applied for a 4-week period
16305717|NCT00606697|Drug|GW597599|15 mg
16305253|NCT00610207|Device|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)|Surgical placement of the Surgisis AFP is performed under general anesthesia
16305254|NCT00610194|Drug|RDEA119|In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.
16305255|NCT00610181|Procedure|MRI|MRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery.
16305256|NCT00610168|Biological|Boostrix TM|Single booster dose of vaccine
16305257|NCT00610155|Drug|Placebo|BID
16305258|NCT00610155|Drug|Pregabalin|Dose 75 mg titrated to 150 mg, bid
16305259|NCT00610155|Drug|Tramadol SR|Dose 50mg titrated to 200 mg, bid
16305260|NCT00610142|Drug|pimecrolimus 1% cream|twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
16305261|NCT00610142|Drug|hydrocortison 1% cream|twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks
16305262|NCT00610129|Drug|MK-0646|MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.
16305263|NCT00610116|Device|Electronic Repositioning|Change of pacing vectors for CRT pacing
16305264|NCT00610103|Drug|apomorphine hydrochloride|Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
16305265|NCT00610090|Device|UniFit AAA Stent Graft|Endovascular repair of Abdominal Aortic Aneurysms
16305266|NCT00610077|Drug|Letrozole|Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
16305267|NCT00610077|Drug|Clomiphene citrate|Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
16305268|NCT00610064|Radiation|Baseline neuroimaging|Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
16305269|NCT00610064|Radiation|Neuroimaging during sacral neuromodulation|Neuroimaging during sacral neuromodulation using PET
16305270|NCT00610051|Drug|Alprostadil|central venous access continuous delivery with 2.5ng/kg/min
16305271|NCT00610038|Drug|glibenclamide|Switching the patients from subcutaneous insulin to oral glibenclamide therapy
16305272|NCT00610025|Procedure|Transgastric access to the abdomen|Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
16305273|NCT00609999|Drug|Erlotinib and Dasatinib|You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
16305274|NCT00609986|Drug|insulin|"The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
~After the regular insulin infusion is discontinued, the blood sugar levels will be measured by a finger stick blood glucose up to 5-6 times per day and the blood sugar levels will be corrected by a subcutaneous basal-bolus insulin injection for a blood sugar goal 70-110 mg/dL.
~Upon discharge from the hospital, the patient will be placed on a basal-bolus regimen consisting of 3-4 insulin injections to maintain a blood sugar between 70-140."
16305275|NCT00609986|Drug|NPH Insulin or glargine insulin and aspartame insulin|"The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.
~The blood sugar level will be checked every 1 hour while in the operating room and treated with rapid-acting insulin as needed to keep the blood sugar levels 70-180 mg/dL. The blood sugar level will be checked every 4 hours when in the recovery room and on the 6 East transplant unit. Once the patient is able to eat, the blood sugar will be checked five times a day (before meals, at bedtime, and at 3:00 am). Long-acting and rapid-acting insulin will be used to maintain the target blood sugar level.
~Upon discharge from the hospital, the patient will be placed on a minimum of one to two insulin injections to maintain a blood sugar between 90-180 mg/dL"
16305276|NCT00609973|Drug|Ciprofloxacin|Ciprofloxacin 500 mg oral bid for 6 months
16305277|NCT00609973|Drug|Placebo|Placebo bid for 6 months
16305278|NCT00609960|Behavioral|clowns present|clowns present during the proccess of induction of anesthesia
16305279|NCT00609960|Drug|midazolam|midazolam
16305280|NCT00609947|Device|Endeavor Zotarolimus-Eluting Coronary Stent|
16305281|NCT00609934|Drug|Sorafenib|Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84
16305282|NCT00609934|Radiation|external beam radiotherapy|3000cGy in 10 fractions
16305283|NCT00609921|Drug|ARQ197|treatment
16305284|NCT00609908|Procedure|Split skin graft|After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
16305285|NCT00609908|Procedure|skin stretching device|after woundbed preparation the wound is primarily closed by aid of the skin stretching device
16305286|NCT00609908|Procedure|serial excision|as much scar as possible is excised, whereafter the wound is closed
16305287|NCT00609908|Procedure|skin stretching device|after the scar is excised, the wound is primarily closed by aid of the skin stretching device
16305288|NCT00609895|Drug|INSULIN GLARGINE|
16305289|NCT00609882|Other|Nasal CPAP|"Infants randomized to the Standard nasal CPAP via bubble or ventilator support at levels of 4-8 cm H2O post extubation"
16305290|NCT00609882|Other|Humidified High Flow Nasal Cannula (HHFNC)|HHFNC
16305291|NCT00609869|Drug|Lenalidomide|Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.
16305359|NCT00609492|Biological|GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)|Single dose, intramuscular injection
16305292|NCT00609869|Drug|Rituximab|Rituximab was administered at 375 mg/m^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.
16305293|NCT00609856|Drug|pioglitazone|tablet, 30 mg, once daily, 26 weeks
16305294|NCT00609856|Drug|insulin glargine|subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
16305295|NCT00609843|Other|Lipiodol demarcation of the bladder tumour|1-3 drops of Lipiodol Ultra Fluid (iodine 38%W/W) will be injected into the submucosa on 4 locations around the bladder tumour. The procedure is done once during a planned cystoscopy approximately a week before the planning CT.
16305296|NCT00609830|Behavioral|Tailored Materials|Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
16305297|NCT00609830|Behavioral|Tailored Materials Plus Physician Feedback|Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
16305298|NCT00609830|Behavioral|Generic Materials|Participants received generic written educational materials about osteoporosis prevention.
16305299|NCT00609830|Behavioral|No Information|Participants received no informational materials.
16305300|NCT00609817|Drug|GCS-100|GCS-100 160mg/m2 IV (in the vein) on Study Days 1, 4, 8 and 11 for up to 12 consecutive 21-day treatment cycles. Three patients will be assigned to each cohort until maximum tolerated dose is reached. The dose levels: 1) 160 mg/m2; 2) 210 mg/m2; 3) 280 mg/m2; 4) 370 mg/m2
16305301|NCT00609817|Drug|Bortezomib/Dexamethasone|Bortezomid 1.3 mg/m2 and dexamethasone 20 mg/day plus an additional 20 mg of dexamethasone on the day following each of the GCS-100/bortezomib and dexamethasone dosing. GCS-100/bortezomib and dexamethasone dosed on Study Days 1, 4, 8 and 11 of each 21-day cycle after disease progression is noted.
16305302|NCT00609804|Drug|Sorafenib|Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
16305303|NCT00609804|Drug|Erlotinib|Erlotinib 150 mg once daily by mouth
16305304|NCT00609791|Drug|paclitaxel albumin-stabilized nanoparticle formulation|100 mg/m2 3 weeks on 1 week off
16305305|NCT00609791|Other|pharmacological study|Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours
16305306|NCT00609791|Other|physiologic testing|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
16305307|NCT00609791|Other|questionnaire administration|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
16305308|NCT00609791|Other|study of socioeconomic and demographic variables|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
16305309|NCT00609791|Procedure|cognitive assessment|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
16305310|NCT00609791|Procedure|psychosocial assessment and care|Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
16305311|NCT00609778|Device|LUCAS|Mechanical chest compression
16305312|NCT00609778|Other|Conventional manual resuscitation method|Manual compression
16305313|NCT00609765|Drug|Avastin|Every 28 Days: Avastin 5mg/kg iv days 1 and 15
16305314|NCT00609765|Drug|Fluorouracil|Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5
16305315|NCT00609765|Drug|Doxorubicin|Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1
16305316|NCT00609765|Drug|Streptozocin|Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
16305317|NCT00609765|Drug|Dexamethasone|Premedication: Dexamethasone 20mg intravenously days 1-5
16305318|NCT00609765|Drug|Ondansetron|Premedication: Ondansetron 16mg intravenously days 1-5
16305319|NCT00609752|Drug|prednisolone|Standard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period.
16305320|NCT00609752|Dietary Supplement|Alicalm (polymeric liquid formula)|"Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a normal unrestricted diet by 10 weeks."
16305321|NCT00609739|Drug|cyclosporine|Patients will receive CSA therapy beginning on day -3, with a taper commencing on day +60 (unless GVHD) and ending on day +90. For patients >40 kg with normal renal function (creatinine <1.3 mg/dL), the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children <40 kg, the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
16305322|NCT00609739|Drug|cytarabine|3000 mg/m^2 intravenously (IV) over 2 hours x 2 (i.e. total 6000 mg/m^2/day) on days -9 through -4.
16305323|NCT00609739|Drug|filgrastim|Patients with absolute neutrophil count (ANC) <0.2 x 10^8/L on day 21 may receive G-CSF at 5 mcg/kg/day. G-CSF will be continued until ANC ≥2.5 x 10^8/L for two consecutive days. As the malignant cell population of JMML is known to be hypersensitive to GM-CSF, this cytokine will not be given to these patients.
16305324|NCT00609739|Drug|methotrexate|MTX will be administered to recipients of non-genotypically identical BMT. MTX will be administered at a dose of 15 mg/m^2 (based on adjusted ideal body weight) intravenously (IV) on day +1 and at a dose of 10 mg/m^2 IV on days +3, +6, and +11.
16305325|NCT00609739|Drug|methylprednisolone|Recipients of UCB will receive methylprednisolone 2 mg/kg/day from day +5 to +19 at a dose of 1 mg/kg twice a day (bid) with a 10% taper every week thereafter.
16305326|NCT00609739|Drug|mitoxantrone hydrochloride|10 mg/m^2 over 30 minutes intravenously (IV) on days -9 through -7.
16305327|NCT00609739|Procedure|allogeneic bone marrow transplantation|Donor marrow will be collected in the usual sterile manner with a collection goal of 2.0 >10^8/kg recipient weight. Infused on Day 0.
16305328|NCT00609739|Procedure|umbilical cord blood transplantation|Umbilical cord blood (UCB) will be cryopreserved prior to transplantation. Cord blood units will be selected for transplantation according to current University of Minnesota Department of Blood and Marrow Transplantation Guidelines.
16305360|NCT00609492|Biological|Infanrix™-IPV/Hib|Single dose, intramuscular injection
16305329|NCT00609739|Drug|Cis-Retinoic acid|Post-Transplant Cis-Retinoic Acid (CRA) Therapy - CRA will be given at a dosage of 100 mg/m^2/day by mouth in a single daily dose starting on day +60 and continuing until 1 year after transplant.
16305330|NCT00609713|Behavioral|Comprehensive behavioral weight control program|Participants will meet weekly for 12 weeks, then every other week for 12 weeks, and once a month thereafter through week 52. Adolescents and parents will receive manuals that provide lessons and homework assignments for each meeting. The program for the first 22 weeks includes the following topics: 1) the causes of obesity; 2) components of healthy nutrition; 3) self-monitoring of calories, physical activity, and inactivity; 4) stimulus control procedures; 5) coping with high-risk social or psychological situations that trigger excess eating; 6) increasing physical activity; and 7) minimizing inactivity. At each session, participants will submit their self-monitoring diaries and completed homework. Incentives for completion of self-monitoring tasks are an integral part of the behavior modification program and a small gift certificate will be given to subjects for successful completion at each intervention session.
16305331|NCT00609713|Other|Individual 12-month nutrition education program|The other half of the participants (44 subjects) will be randomized to this arm of the intervention (usual care), which will also start in five waves. In contrast to the comprehensive behavioral weight control program, the nutrition education program will take place through individual appointments with a clinical dietician to reflect usual care and mimic the present approach used for the treatment of obese adolescents at the Children's Hospital of Philadelphia (CHOP) Nutrition Consultation. Parents will be required to take part in the consultations. The first consultation will last 60 minutes and the following consultations of 30 minutes will take place once a month for the first six months, then every other month for the second six months, as is the usual practice in our clinical setting.
16305332|NCT00609687|Procedure|Diagnostic Vitrectomy|"Three-port, 20-gauge pars plana vitrectomy instrumentation was utilized. An infusion line was inserted into one sclerotomy and secured to the globe. A second sclerotomy was made, and a fiberoptic light pipe was immediately inserted to minimize vitreous egress. A third sclerotomy was created, and the vitreous cutter was inserted. To obtain an undiluted vitreous sample, the vitreous was cut mechanically with the vitreous cutter, while the assistant surgeon simultaneously manually aspirated the vitreous. After sufficient undiluted sample was obtained, infusion fluid was allowed to enter the eye and a diluted vitreous sample was obtained in a similar manner. The samples were personally carried to the clinical laboratories by the operating surgeon.
~Vitreous fluid analysis was guided by clinical suspicion based on the pre-operative differential diagnosis and the intraoperative posterior segment appearance."
16305333|NCT00609674|Drug|Fluticasone furoate nasal spray|Fluticasone furoate nasal spray
16305334|NCT00609674|Drug|Placebo|Placebo
16305335|NCT00609648|Behavioral|Computer Assisted Relaxation Learning|A self-paced computer program for reducing dental injection fear.
16305336|NCT00609648|Behavioral|Pamphlet|A pamphlet reassuring patients about dental injections.
16305337|NCT00609622|Drug|sunitinib|Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
16305338|NCT00609622|Drug|mFOLFOX6|FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
16305339|NCT00609622|Drug|bevacizumab|Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
16305340|NCT00609622|Drug|mFOLFOX6|FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
16305341|NCT00609609|Procedure|Photopheresis|8-9 photopheresis treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments.
16305342|NCT00609609|Drug|Methylprednisolone|2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.
16305343|NCT00609596|Drug|GI198745|
16305344|NCT00609570|Dietary Supplement|NanoGreens|fruits and vegetables
16305345|NCT00609570|Dietary Supplement|Whey protein|Whey
16305346|NCT00609570|Dietary Supplement|Calcium pills|CA
16305347|NCT00609557|Drug|duloxetine|Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop
16305348|NCT00609544|Drug|Rilonacept|Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
16305349|NCT00609531|Drug|Citalopram|Pill, 5-20mg once a day for twelve weeks
16305350|NCT00609531|Drug|Placebo|Placebo pill once a day for twelve weeks
16305351|NCT00609518|Drug|pemetrexed|500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.
16305352|NCT00609518|Dietary Supplement|Folic acid|350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.
16305353|NCT00609518|Dietary Supplement|Folic Acid|350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.
16305354|NCT00609518|Dietary Supplement|Vitamin B12|1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
16305355|NCT00609518|Drug|dexamethasone|4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.
16305356|NCT00609518|Drug|dexamethasone|4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.
16305357|NCT00609505|Other|Telemedicine|Telemedicine genetic counseling
16305358|NCT00609505|Other|Face-to-Face|Face-to-face genetic counseling
16305361|NCT00609479|Procedure|Osteosynthesis|"Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12.
~Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12."
16305362|NCT00609466|Drug|CG5503 IR|75mg IR 4 - 6 hourly Total: 72 hours
16305363|NCT00609466|Drug|Morphine|Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
16305364|NCT00609466|Drug|Placebo|Placebo; 4 - 6 hourly; Total: 72 hours
16305365|NCT00609453|Behavioral|Brief Behavioral Activation Treatment for Depression|Weekly individual therapy sessions
16305366|NCT00609440|Other|physiotherapeutic treatment|At first, the patient was submitted to a conventional physiotherapeutic treatment and respiratory exercises; then, we gave emphasis to the motor development marks and to the march training; eventually, the kid was conducted to hydrotherapy.
16305367|NCT00609427|Behavioral|MEMO programme (Inst Universitaire de Geriatrie, Montreal)|8 weekly group training sessions in mnemonic strategies, administered by clinical psychologist.
16305368|NCT00609427|Behavioral|External memory aids training|8 weekly group sessions of training in the use of external memory aids, administered by clinical psychologist
16305369|NCT00609401|Drug|Nexavar (Sorafenib)|400 mg bid
16305370|NCT00609401|Drug|IL-2|IL-2 3 MU per 5 day/week for 2 weeks every 4
16305371|NCT00609388|Drug|Tacrolimus|Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
16305372|NCT00609388|Other|Saline solution 0.9% (250mL)|intraoperative intraportal infusion of Saline solution 0.9% (250mL)
16305373|NCT00609375|Drug|cefepime|Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.
16305374|NCT00609375|Drug|cefepime|Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours
16305375|NCT00609362|Drug|Rosiglitazone|one tablet of rosiglitazone 8 milligrams per day for 14 weeks
16305376|NCT00609362|Drug|Placebo pill|One encapsulated placebo pill a day for 14 weeks
16305377|NCT00609349|Device|ETED, CPET, RHC|"exercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2)
~right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values"
16305378|NCT00609336|Drug|gemcitabine hydrochloride|Given IV
16305379|NCT00609336|Drug|docetaxel|Given IV
16305380|NCT00609336|Drug|capecitabine|Given PO
16305381|NCT00609336|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16305382|NCT00609336|Drug|oxaliplatin|Given IV
16305383|NCT00609336|Procedure|pancreatic surgical procedure|Undergo pancreaticoduodenectomy
16305384|NCT00609336|Procedure|therapeutic conventional surgery|Undergo therapeutic conventional surgery
16305385|NCT00609336|Other|laboratory biomarker analysis|Correlative studies
16305386|NCT00609323|Drug|lidocaine and tetracaine cream 7%/7%|One treatment of up to 400 cm2 Cream applied for 60 minutes.
16305387|NCT00609323|Drug|Placebo|One treatment of up to 400 cm2 Cream applied for 60 minutes.
16305388|NCT00609310|Dietary Supplement|Flavonoids|Nutritional Supplement: flavonoid mixture with 20 mg apigenin and 20 mg epigallocathechin gallate as tablets per day
16305389|NCT00609297|Other|medical chart review|The Research Nurse will conduct a chart review after the patient's death.
16305390|NCT00609297|Other|questionnaire administration|The questionnaires will be completed at the end of week 1, week 2 and week 4.
16305391|NCT00609297|Other|survey administration|Given to patient and caregivers throughout the study
16305392|NCT00609284|Drug|cetuximab|D-7, D1, D8, D15, D22, D29, D43, D50
16305393|NCT00609284|Drug|Carboplatin, 5FU concomitant|Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
16305394|NCT00609284|Radiation|Radiotherapy|70 Gy in 7 weeks
16305395|NCT00609271|Behavioral|low carbohydrate diet|<40 grams carbohydrate/day
16305396|NCT00609271|Behavioral|low fat diet|<30% fat, <7% saturated fat
16305397|NCT00609245|Drug|Valproic Acid|The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
16305398|NCT00609245|Drug|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
16305399|NCT00609219|Biological|autologous EBV specific CTLs|"30-40cc of peripheral blood will be used to generate EBV specific CTLs
~Group One:
~Day 0 - 2 x 10^7 cells/m2 Day 14 - 2 x 10^7 cells/m2
~Group Two:
~Day 0 - 2 x 10^7 cells/m2 Day 14 - 1 x 10^8 cells/m2
~Group Three:
~Day 0 - 1 x 10^8 cells/m2 Day 14 - 2 x 10^8 cells/m2"
16305400|NCT00609193|Drug|lithium|standard clinical care
16305401|NCT00609193|Drug|quetiapine|standard clinical care
16305402|NCT00609180|Behavioral|Minimal (Trophic) Feeding|Enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.
16305403|NCT00609180|Behavioral|Full Feeding|Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.
16305404|NCT00609180|Dietary Supplement|Omega-3 Fatty Acids and Antioxidant Supplements|Omega-3 fatty acids, GLA, and antioxidants will be administered through a feeding tube every 12 hours as a 120-cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
16305405|NCT00609180|Dietary Supplement|Placebo|The study placebo will be administered through a feeding tube every 12 hours as a 120 cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
16305406|NCT00609167|Drug|bortezomib|"First 33 patients: 1.3 mg/m^2 IV Days 1, 4, 8 & 11
~Remaining 30 patients: 1.5 mg/m^2 IV Days 1, 8, 15 & 22"
16305407|NCT00609167|Drug|cyclophosphamide|300mg/m^2 PO days 1, 8, 15 & 22
16305408|NCT00609167|Drug|dexamethasone|"First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20
~Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond"
16305409|NCT00609154|Drug|glucagon like peptide-1|GLP-1 1 pmole/kg/min
16305410|NCT00609154|Dietary Supplement|glucose control|glucose without GLP-1
16305411|NCT00609141|Biological|cixutumumab|Given IV
16305412|NCT00609141|Other|pharmacological study|Correlative studies
16305413|NCT00609141|Other|laboratory biomarker analysis|Correlative studies
16305414|NCT00609128|Drug|olopatadine|olopatadine one drop in one eye for one week
16305415|NCT00609115|Device|AMES device|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
16305416|NCT00609115|Device|AMES device (sham)|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
16305417|NCT00609115|Device|AMES device|Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
16305418|NCT00609102|Drug|Placebo|one capsule BID
16305419|NCT00609102|Drug|n-aceylcysteine|450 mgm BID
16305420|NCT00609089|Behavioral|CRAFT-T|The Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction treatment (CRAFT-T) was be developed in phase 1 and 2 of the current study and consists of twelve manual-guided weekly one-hour individual sessions for the concerned significant other and 2 one hour sessions for the identified patient. The intervention also allows for up to two additional sessions (total of 14 visits) to help arrange re-entry into substance abuse treatment when needed. The identified patient receives this intervention in addition to the usual services at the drug treatment program (Maryhaven).
16305421|NCT00609089|Behavioral|Treatment as usual|Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.
16305422|NCT00609063|Drug|Atorvastatin|80-mg atorvastatin capsules taken daily for 6 months
16305423|NCT00609063|Drug|Placebo|Placebo capsules taken daily for 6 months
16305424|NCT00609050|Behavioral|Self-Regulated Exercise with Telephone Reinforcement|The self-regulated exercise with telephone reinforcement group will engage in a three-times-a-week (or more) at home exercise regimen for 6 months during which they may choose the mode of exercise. They will receive weekly telephone calls about exercise and airway clearance. After 6 months, they will be instructed to maintain their self-regulated exercise activity for the remaining 6 months of the study, but they will not receive telephone calls
16305425|NCT00609050|Behavioral|Standard Treatment|The attention control group will receive standard recommendations for exercise activity, during the first 6 months, as is common in our clinic. Also during the first 6 months, they will receive weekly telephone calls about airway clearance. For the final 6 months of the study, the attention control group will cross over to self-regulated exercise without telephone reinforcement.
16305426|NCT00609050|Behavioral|Qualitative Approach|A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
16305427|NCT00609011|Drug|MPC-6827 + Temozolomide|MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Temozolomide at 85 mg/m2 administered orally daily for 21 days in a 4 week cycle.
16305428|NCT00608985|Drug|almorexant|2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
16305429|NCT00608985|Drug|almorexant|1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
16305430|NCT00608985|Drug|Placebo|2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
16305431|NCT00608985|Drug|zolpidem|2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
16305432|NCT00608972|Drug|Doxil|Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
16305433|NCT00608972|Drug|Carboplatin|Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
16305434|NCT00608972|Drug|Bevacizumab|Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
16305435|NCT00608959|Drug|omiganan 1% gel|"Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2).
~In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site."
16305436|NCT00608959|Drug|chlorhexidine 2% solution|"Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days.
~Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only."
16305437|NCT00608946|Dietary Supplement|copper|intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
16305438|NCT00608946|Dietary Supplement|placebo|placebo
16305439|NCT00608933|Other|educational intervention|Health providers receive educational materials comprising a brief video about communicating with and providing guidance to patients regarding complimentary and alternative medicine (CAM) and a list of resources they can access to obtain information about herbs, CAM modalities, and drug/herb interactions. Approximately 2 weeks after the educational intervention, health providers receive a follow-up e-mail reminding them to ask patients about CAM use. The e-mail also includes a brief update regarding current research findings on CAM modalities and drug/herb interactions.
16305440|NCT00608933|Other|questionnaire administration|Patients complete questionnaires
16305441|NCT00608920|Other|Single Photon Emission Computed Tomography (SPECT)|
16305442|NCT00608907|Drug|bortezomib|1.3 mg/m^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
16305443|NCT00608907|Drug|bortezomib, rifampicin|bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3
16305542|NCT00608179|Other|glucose clamp|hypoglycemic glucose clamp procedure -120 minutes
16305444|NCT00608907|Drug|bortezomib, dexamethasone|bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3
16305445|NCT00608894|Drug|LCP-Tacro (tacrolimus)|LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
16305446|NCT00608894|Drug|Azathioprine|Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
16305447|NCT00608881|Drug|coenzyme Q10|4 - 300 mg CoQ chewable wafers taken orally twice a day
16305448|NCT00608881|Other|placebo|an inactive substance
16305449|NCT00608868|Drug|Gefitinib|Gefitinib tablet 250mg once daily orally
16305450|NCT00608855|Other|questionnaire administration|
16305451|NCT00608855|Procedure|cryosurgery|
16305452|NCT00608855|Procedure|pain therapy|
16305453|NCT00608855|Procedure|quality-of-life assessment|
16305454|NCT00608842|Drug|Deoxycholic Acid Injection|Administered via intralipomal injection.
16305455|NCT00608842|Drug|Placebo|Matching vehicle placebo administered via intralipomal injection.
16305456|NCT00608829|Device|GORE TAG® Thoracic Endoprosthesis|Implant
16305457|NCT00608816|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
16305458|NCT00608816|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2
16305459|NCT00608803|Drug|ZIO-201-T and doxorubicin|ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
16305460|NCT00608790|Drug|Salbutamol|Prophylactic salbutamol administered at a dose of 200 micrograms by metered dose inhaler (MDI) via a spacer.
16305461|NCT00608790|Drug|Sodium chloride 5%|30 ml sterile hypertonic saline solution (sodium chloride 5%) will be administered by jet nebulisation for 15-20 minutes.
16305462|NCT00608777|Drug|Calcipotriene/betamethasone|One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
16305463|NCT00608751|Radiation|IMRT|
16305464|NCT00608738|Other|informational intervention|
16305465|NCT00608738|Other|medical chart review|
16305466|NCT00608738|Other|questionnaire administration|
16305467|NCT00608738|Procedure|assessment of therapy complications|
16305468|NCT00608738|Procedure|management of therapy complications|
16305469|NCT00608725|Radiation|DAXOR|131-I-Human Serum Albumin Blood Volume Assessment Kit
16305470|NCT00608725|Procedure|QSweat|Quantitative Sweat Testing
16305471|NCT00608725|Drug|Intrinsic Heart Rate|Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses
16305472|NCT00608712|Drug|Esomeprazole|Esomeprazole 20mg oral tablet
16305473|NCT00608699|Drug|GSK256073A tablets + IR niacin tablets|single dosing for 4 to 5 sessions
16305474|NCT00608686|Dietary Supplement|Pregnenolone|30mg of pregnenolone administered orally, once, at 2 of 5 study visits.
16305475|NCT00608673|Drug|Pimecrolimus 1% cream|a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
16305476|NCT00608673|Drug|betamethasone valerate 0.1% cream|A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.
16305477|NCT00608660|Other|acupuncture|staging acupuncture
16305478|NCT00608660|Other|acupuncture and moxibustion|staging acupuncture and moxibustion
16305479|NCT00608660|Other|electroacupuncture|staging electroacupuncture
16305480|NCT00608660|Other|acupuncture along yangming tendons|staging acupuncture along Yangming musculature
16305481|NCT00608660|Other|acupuncture|non-staging acupuncture
16305482|NCT00608634|Drug|perillyl alcohol|Applied as topical cream
16305483|NCT00608634|Other|placebo|Applied as topical cream
16305484|NCT00608595|Drug|celecoxib|Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
16305485|NCT00608595|Genetic|gene expression analysis|not noted
16305486|NCT00608595|Genetic|protein expression analysis|Not noted
16305487|NCT00608595|Other|immunohistochemistry staining method|not noted
16305488|NCT00608595|Other|laboratory biomarker analysis|not noted
16305489|NCT00608595|Other|mass spectrometry|
16305490|NCT00608595|Procedure|biopsy|At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
16305491|NCT00608595|Procedure|neoadjuvant therapy|not noted
16305492|NCT00608595|Procedure|therapeutic conventional surgery|not noted
16305493|NCT00608582|Device|Transcranial Magnetic Stimulation, Repetitive|10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
16305494|NCT00608569|Drug|Lopinavir/ritonavir|Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily
16305495|NCT00608569|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily
16305496|NCT00608569|Drug|Tenofovir disoproxil fumarate|300-mg tablet taken orally once daily
16305497|NCT00608569|Drug|Zidovudine|300-mg tablet taken orally twice daily
16305498|NCT00608569|Drug|Emtricitabine|200-mg tablet taken orally once daily
16305499|NCT00608543|Drug|Aripiprazole|varied dose (5, 10, 15 mg qd) for 6 wks
16305500|NCT00608530|Behavioral|Cognitive Behavioral Therapy-Psychologist-Delivered|Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist
16305501|NCT00608530|Behavioral|Supportive Psychotherapy-Psychologist-Delivered|Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was administered by a psychologist
16305575|NCT00607932|Other|questionnaire administration|
16305502|NCT00608530|Behavioral|Cognitive Behavioral Therapy Nurse-Delivered|Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse
16305503|NCT00608530|Behavioral|Supportive Psychotherapy-Nurse-Delivered|Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian Therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was delivered by a nurse
16305504|NCT00608517|Biological|anti-thymocyte globulin|Given IV
16305505|NCT00608517|Drug|cyclophosphamide|Given IV
16305506|NCT00608517|Drug|fludarabine phosphate|Given IV
16305507|NCT00608517|Drug|methylprednisolone|Given IV
16305508|NCT00608517|Radiation|total-body irradiation|Given daily for 1-4 days
16305509|NCT00608491|Drug|Stepped pharmacologic care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.
16305510|NCT00608491|Device|Ultrafiltration|All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.
16305511|NCT00608465|Drug|Eplerenone|5 mg x 1 week followed by 10 mg x 9 weeks.
16305512|NCT00608465|Drug|Ramipril|Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.
16305513|NCT00608452|Other|Symptom Assessment Scale|"Memorial Symptom Assessment Scale
~History and neurologic examination"
16305514|NCT00608439|Drug|Centella asiatica selected triterpenes (CAST)|Drug provided to subjects in 60 mg capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52.
16305515|NCT00608439|Other|Placebo|"Placebo provided to subjects in 60 mg color-matched capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52."
16305516|NCT00608426|Behavioral|Proactive Outreach with choice of telephone or in-person smoking cessation services|This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
16305517|NCT00608400|Dietary Supplement|Clarinol CLA|0, 1.5 or 3.0 g/d dietary conjugated linoleic acids glycerides for 4 months, capsule form
16305518|NCT00608387|Behavioral|Chronic disease management Web-based software|Participants will have access to remotely based medical providers through the use of the Web-based software.
16305519|NCT00608374|Drug|chlorambucil|
16305520|NCT00608374|Drug|fludarabine phosphate|
16305521|NCT00608374|Procedure|quality-of-life assessment|
16305522|NCT00608361|Drug|Dasatinib|Given PO
16305523|NCT00608361|Other|Pharmacological Study|Correlative studies
16305524|NCT00608348|Procedure|Hyperinsulinemic glucose clamp procedures|2 hours of either euglycemic or hypoglycemic glucose clamping
16305525|NCT00608348|Procedure|moderate exercise|90 minutes of moderate exercise with either hyperinsulinemia or euinsulinemia
16305526|NCT00608335|Drug|Micafungin|IV
16305527|NCT00608322|Drug|Inhaled nitric oxide|Inhaled nitric oxide, 40 parts per million, for six hours.
16305528|NCT00608322|Other|Sham inhaled nitric oxide|Sham inhaled nitric oxide administration, 0 parts per million, for six hours.
16305529|NCT00608244|Drug|LCP Tacro|"In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.
~LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.
~Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL."
16305530|NCT00608244|Drug|Prograf|Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.
16305531|NCT00608231|Drug|Dexmedetomidine Hydrochloride Infusion|Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
16305532|NCT00608231|Drug|Normal Saline|Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
16305533|NCT00608218|Drug|Ciclesonide|This is an observational study. Therefore, the physician decides about dosage according to individual needs.
16305534|NCT00608205|Drug|cisplatin|Given IV
16305535|NCT00608205|Drug|fluorouracil|Given IV
16305536|NCT00608205|Radiation|radiation therapy|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
16305537|NCT00608192|Behavioral|Testing, Education, & Counseling (TEC)|Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral.
16305538|NCT00608192|Behavioral|Hepatitis Care Coordination (HCC)|HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care.
16305539|NCT00608179|Drug|Glimepiride|Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.
16305540|NCT00608179|Drug|glyburide|Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.
16305541|NCT00608179|Other|glucose clamp|Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes
16305543|NCT00608140|Procedure|Surgical mitral valvuloplasty with placement of annular ring (SMVR)|Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
16305544|NCT00608140|Drug|Optimal medical therapy (OMT)|Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.
16305545|NCT00608127|Device|LupusorbTM|Single treatment
16305546|NCT00608101|Drug|Fludrocortisone|Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
16305547|NCT00608101|Drug|Dexamethasone|Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1
16305548|NCT00608088|Behavioral|Usual Care|"The usual care group will received standard care from the Johns Hopkins Hospital lactation consultant and nurses, which may have included a visit in the hospital by the lactation consultant if mothers delivered Monday through Friday. The lactation consultant was also available by request. A warm-line was also standard. This was a telephone line that was connected to an answering machine; the lactation consultant checked this line once daily (Monday through Friday) and returned calls."
16305549|NCT00608088|Behavioral|Community Health Nurse/Peer Councelor Team|"Visits by a community health nurse/peer counselor team during the first six postpartum months. Based on prior research and experience, the team was developed to provide culturally relevant support and health-care education to low-income mothers, who were a high percentage of African American women. The goals of this team were to 1) increase the duration of breastfeeding while emphasizing ways to decrease fatigue, and decrease breast discomfort; 2) strengthen maternal competence with breastfeeding and commitment to breastfeeding; 3) provide parent education about the infant regarding breastfeeding; 4) provide/find social support needed for continued breastfeeding; and 5) foster linkages to community services that will facilitate the maintenance of breastfeeding.
~The specific activities of the CHN/peer counselor team included hospital visitation after enrollment, home visiting during the first postpartum month, and telephone support throughout the first six postpartum months."
16305550|NCT00608075|Drug|lithium|600 mg - 1800 mg per day
16305551|NCT00608075|Drug|Lithium|600 - 1800 mg
16305552|NCT00608062|Drug|GnRHant - Ganirelix acetate|1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7
16305553|NCT00608062|Drug|Transdermal estradiol patch|0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
16305554|NCT00608062|Drug|Transdermal placebo patch|Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
16305555|NCT00608049|Behavioral|High carbohydrate and low glycemic index (GI) diet|The high carbohydrate and low GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.
16305556|NCT00608049|Behavioral|Low carbohydrate and low GI diet|The low carbohydrate and low GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.
16305557|NCT00608049|Behavioral|High carbohydrate and high GI diet|The high carbohydrate and high GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.
16305558|NCT00608049|Behavioral|Low carbohydrate and high GI diet|The low carbohydrate and high GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.
16305559|NCT00608023|Drug|Tesamorelin|
16305560|NCT00608023|Drug|Placebo for Tesamorelin|
16305561|NCT00608010|Procedure|Vitrification|Embryos were vitrified according to a previously described technique
16305562|NCT00608010|Procedure|Slow freezing|Embryos were frozen with slow freezing technique
16305563|NCT00607997|Drug|vosaroxin|Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.
16305564|NCT00607984|Drug|thiotepa melphalan|thiotepa 900 mg per meter squared total, on days -11,-10,-4,-3 melphalan 140 mg per meter squared total on days -11,-10,-4,-3 autologous stem cell transplant in day 0
16305565|NCT00607971|Drug|Renzapride|All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52
16305566|NCT00607958|Drug|tipranavir/ritonavir (dose reduction)|tipranavir/ritonavir 500/100 BID
16305567|NCT00607945|Drug|Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant|Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
16305568|NCT00607945|Dietary Supplement|conjugated linoleic acid (CLA)|3.2 g/day, capsule, week 0 to week 32
16305569|NCT00607945|Dietary Supplement|conjugated linoleic acid (CLA)|6.4 g/day, capsule, week 0 to week 32
16305570|NCT00607932|Behavioral|behavioral dietary intervention|
16305571|NCT00607932|Dietary Supplement|Brassica vegetable|
16305572|NCT00607932|Drug|indole-3-carbinol|follow up at 2,4,6 months post baseline.
16305573|NCT00607932|Other|counseling intervention|2, 4, 6 months post baseline
16305574|NCT00607932|Other|medical chart review|2,4,6 months post baseline
16305577|NCT00607919|Drug|Atomoxetine|Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks
16305578|NCT00607919|Drug|Placebo|oral, daily, for 16 weeks
16305579|NCT00607906|Drug|SB-756050 immediate release capsule|SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050.
16305580|NCT00607906|Drug|SB-756050 modified release capsule|SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050.
16305581|NCT00607906|Drug|Placebo|Subjects will also receive placebo capsules.
16305582|NCT00607893|Device|Continuous Positive Airway Pressure (CPAP)|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
16305583|NCT00607893|Device|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
16305584|NCT00607880|Procedure|vascular access device placement|
16305585|NCT00607867|Other|LoBAG30 diet|A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.
16305586|NCT00607867|Other|Control Diet|A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
16305587|NCT00607854|Drug|Ibritumomab Tiuxetan (Zevalin)|"Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.
~Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)"
16305588|NCT00607841|Drug|Ispinesib|10 mg/m2 dose as a 1-hour intravenous infusion.
16305589|NCT00607841|Drug|Ispinesib|12 mg/m2 dose as a 1-hour intravenous infusion.
16305590|NCT00607841|Drug|Ispinesib|14 mg/m2 dose as a 1-hour intravenous infusion.
16305591|NCT00607828|Radiation|stereotactic body radiation therapy|Undergo radiotherapy
16305592|NCT00607815|Behavioral|Cognitive Processing Therapy|CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
16305593|NCT00607815|Behavioral|Present Centered Therapy|"Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
16305594|NCT00607802|Biological|leukocyte therapy|
16305595|NCT00607802|Genetic|polymerase chain reaction|
16305596|NCT00607789|Drug|Duloxetine|30 mg/day - 120 mg/day
16305597|NCT00607789|Drug|Placebo|identical to study drug
16305598|NCT00607776|Drug|(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400|Drops
16305599|NCT00607776|Drug|Systane|Drops
16305600|NCT00607763|Drug|Micafungin (Mycamine)|IV
16305601|NCT00607750|Drug|ATG003 (mecamylamine)|1% Ophthalmic solution, eyedrop BID, 48 weeks
16305602|NCT00607750|Drug|Placebo|Placebo eyedrops, BID, 48 weeks
16305603|NCT00607737|Drug|insulin detemir|3 cutaneous injections
16305604|NCT00607737|Drug|saline|3 cutaneous injections
16305605|NCT00607724|Drug|GDC-0449|
16305606|NCT00607711|Drug|oral palifosfamide tris|Capsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm.
16305607|NCT00607685|Drug|5 Fluorouracil with hyaluronic acid|Participants will receive a subconjunctival injection of 0.1ml of a mixure of 5 Fluorouracil (50mg/ml) with hyaluronic acid (23mg/ml) once at enrollment into the study.
16305608|NCT00607685|Drug|5 Fluorouracil|Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment
16305609|NCT00607672|Drug|Placebo|Placebo
16305610|NCT00607672|Drug|Ramipril|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
16305611|NCT00607672|Drug|Candesartan|Candesartan 16mg/d
16305612|NCT00607659|Other|No intervention, only observational|No intervention, only observational
16305613|NCT00607646|Drug|Dehydroepiandrosterone|Placebo tablets or tablets containing DHEA will be given orally before each hyperinsulinemic clamps on day 1 (x 2). Placebo tablets or tablets containing DHEA will be given orally before Day 2 hyperinsulinemic hypoglycemic clamp x 1.
16305614|NCT00607646|Drug|Placebo|Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
16305615|NCT00607620|Behavioral|Brief Intervention|Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
16305616|NCT00607607|Drug|MKC-1|capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
16305617|NCT00607594|Drug|saracatinib|Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.
16305618|NCT00607581|Drug|cyclophosphamide|cyclophosphamide: 500 mg orally on days 1, 8, 15
16305619|NCT00607581|Drug|lenalidomide|lenalidomide: 15 mg orally on days 1-21
16305620|NCT00607581|Drug|dexamethasone|dexamethasone: 40 mg orally on days on days 1, 8, 15, 22
16305621|NCT00607568|Drug|Atomoxetine|"atomoxetine 40mg per day or placebo
~For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II."
16305622|NCT00607555|Device|Insertion of specialized feeding tube for monitoring of EAdi|The specialized feeding tube will be inserted into the esophagus and positioned at the level of the crural diaphragm. EAdi will be measured with miniaturized coated stainless steel electrodes mounted on the feeding tube. The tube is connected to a monitor where EAdi will be recorded continuously throughout the entire study period
16305623|NCT00607542|Drug|baclofen|2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
16305671|NCT00607087|Drug|Insulin glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
16305672|NCT00607087|Drug|Insulin lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
16305624|NCT00607529|Other|hand-held POC creatinine analyzer-blood test|"This study will require the collection of a finger-puncture capillary blood specimen in addition to one green stoppered heparin containing collection tube. This is taken pre-therapy. The capillary whole blood specimen will be used to perform a creatinine determination on the investigational hand-held creatinine analyzer using special test strips for the analysis."
16305625|NCT00607516|Procedure|Cemented primary bipolar hemiarthroplasty of the hip|Cemented primary bipolar hemiarthroplasty of the hip
16305626|NCT00607516|Procedure|Uncemented primary bipolar hemiarthroplasty of the hip|Uncemented primary bipolar hemiarthroplasty of the hip
16305627|NCT00607503|Drug|Terbutaline|"Each subject will be treated with terbutaline for 21-28 days following the initiation of treatment during the CRC admission.
~Subjects weighing between 25 and 45 kg will be treated with a nightly oral dose of 2.5 mg and subjects who weigh more than 45 kg will be treated with 3.75 mg.
~The standard 2.5 mg terbutaline tablets available in a pharmacy will be used in the study, with subjects taking either 1 or 1.5 tablets nightly."
16305628|NCT00607490|Behavioral|Cognitive-Behavioral Therapy|Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
16305629|NCT00607490|Behavioral|Supportive Psychotherapy|Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
16305630|NCT00607477|Drug|Minoxidil|2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
16305631|NCT00607477|Drug|Hydralazine|25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
16305632|NCT00607464|Device|Polyethylene occlusive skin wrap|Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
16305633|NCT00607451|Drug|Neu-120|Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
16305634|NCT00607438|Drug|Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)|125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.
16305635|NCT00607438|Drug|Sorafenib (Nexavar)|400 mg orally twice a day continuously (even during rest week) starting on Day 1.
16305636|NCT00607412|Behavioral|Integrated psychotherapy for PTSD and substance use|integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence
16305637|NCT00607412|Behavioral|12-step based supportive therapy|supportive psychotherapy based on 12-step model
16305638|NCT00607399|Drug|SGX523 Capsules|This is a dose escalation study
16305639|NCT00607386|Biological|Idursulfase|Solution for intravenous infusion, 0.5 mg/kg weekly
16305640|NCT00607373|Drug|mipomersen|200 mg mipomersen administered once a week for 26 weeks as a 1 mL subcutaneous injection. Subjects weighing less than 50 kg received a lower dose of 160 mg (0.8mL) mipomersen.
16305641|NCT00607373|Drug|Placebo|1 mL subcutaneous injection once a week for 26 weeks. Subjects weighing less than 50 kg received 0.8 mL subcutaneous injection.
16305642|NCT00607360|Behavioral|Therapeutic Workplace Intervention|Therapeutic workplace intervention is intended for individuals with drug addiction and chronic unemployment. Participants are invited to participate in work and receive salary for participation and productivity contingent upon drug abstinence.
16305643|NCT00607347|Other|Glucose|Oral Glucose Tolerance Test
16305644|NCT00607334|Behavioral|Word-learning|Exposure to five nonwords for three sessions of controlled interaction with the experimenter
16305645|NCT00607334|Behavioral|Word-learning|Exposure to five nonwords for three sessions of controlled interaction with the experimenter
16305646|NCT00607321|Device|Medtronic Bifurcation Stent System|Percutaneous Coronary Stenting
16305647|NCT00607308|Biological|PF-04360365|Single dose of 0.1 mg/kg IV on Day 1
16305648|NCT00607308|Biological|PF-04360365|Single dose of 0.5 mg/kg IV on Day 1
16305649|NCT00607308|Biological|PF-04360365|Single dose of 1 mg/kg IV on Day 1
16305650|NCT00607308|Biological|PF-04360365|Single dose of 5 mg/kg IV on Day 1
16305651|NCT00607308|Drug|Placebo|Single dose of placebo IV on Day 1
16305652|NCT00607308|Biological|PF-04360365|Single dose of 10 mg/kg IV on Day 1
16305653|NCT00607295|Drug|clino-san vaginal lubricant|Clino-san 2ml vaginal application 3 times per week for 12 weeks
16305654|NCT00607282|Drug|Udenafil|oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
16305655|NCT00607269|Behavioral|Voucher-Based Reinforcement Therapy|"Participants were randomized into either the CM or control condition. Both conditions earned points for attendance and participation (max 364 points).
~Participants in the CM condition also earned points for targeted health-promoting behaviors and for drug/alcohol abstinence. CM points for targeted health-promoting behaviors were not limited. Points for abstaining from substance use were awarded based on a Level 1 (recent abstinence for amphetamine, methamphetamine, PCP, and cocaine metabolites, as well as blood alcohol <0.05) urine sample."
16305656|NCT00607256|Drug|[S,S]-reboxetine|S_S reboxetine dosed daily.
16305657|NCT00607243|Biological|smallpox vaccine CJ-50300|Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
16305658|NCT00607230|Biological|BCG|BCG vaccination at 0 and 4 weeks
16305659|NCT00607230|Biological|Saline|Saline vaccination at 0 and 4 weeks
16305660|NCT00607217|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
16305661|NCT00607217|Biological|placebo for influenza vaccine|Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
16305662|NCT00607217|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
16305663|NCT00607178|Biological|influenza vaccine|Intramuscular injection of one 0.5-mL dose of influenza vaccine
16305664|NCT00607178|Biological|placebo for influenza vaccine|Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
16305665|NCT00607152|Drug|Rasburicase|0.20mg/kg per day IV
16305666|NCT00607152|Drug|Allopurinol|100mg tablets
16305667|NCT00607126|Device|Lokomat|locomotor training using body weight support on a treadmill
16305668|NCT00607126|Procedure|resistive training|resistive training using theraband and/or weights
16305669|NCT00607113|Drug|Avastin|15 mg/kg By Vein Over 90 Minutes Every 21 Days
16305673|NCT00607087|Drug|Insulin aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
16305674|NCT00607074|Drug|Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)|Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)
16305675|NCT00607074|Drug|Anti-Giardia treatment only (secnidazole or albendazole)|Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole
16305676|NCT00607074|Drug|Control group (placebo)|Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo
16305677|NCT00607061|Procedure|Blood sample collection|Blood of the umbilical cord will be collected after delivery. A mother blood sample will be also collected in the few hours preceding delivery to determine glutathione and cysteine concentrations.
16305678|NCT00607048|Drug|Paclitaxel + Carboplatin + CP-870,893|Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
16305679|NCT00607048|Drug|Paclitaxel + Carboplatin + CP-870,893|Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
16305680|NCT00607035|Drug|Olmesartan medoxomil ＋Azelnidipine|The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day for 6 months.
16305681|NCT00607035|Drug|Olmesartan medoxomil + Hydrochlorothiazide|The ARB plus Diuretics combination therapy group is administered olmesartan medoxomil 20mg/day and hydrochlorothiazide 12.5mg/day for 6 months.
16305682|NCT00607022|Device|dental implant|Dental implant stability measured with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement.
16305683|NCT00607009|Behavioral|ALIVE|ALIVE email-based behavioral program based on the participants selected intervention - physical activity, fats/sugars or fruits/vegetabls
16305684|NCT00606996|Behavioral|Group interpersonal psychotherapy (IPT-G)|
16305685|NCT00606996|Behavioral|Psychoeducation on co-occurring disorders (PSYCHOED)|
16305686|NCT00606983|Drug|Tamsulosin|oral administration of Tamsulosin
16305687|NCT00606970|Dietary Supplement|Seigen Alpha EV|Orally administered Seigen Alpha EV, 1 packet (6 grams)3 times daily, for maximum of 3 months. Each packet is clearly marked for breakfast, lunch, or supper. The contents are to be dissolved in water or liquid and taken orally with meal. Subjects will be required to return any unused packets to study doctor at end of each month.
16305688|NCT00606970|Dietary Supplement|Placebo Comparator|Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.
16305689|NCT00606957|Dietary Supplement|Vitamin D3 (cholecalciferol)|Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.
16305690|NCT00606944|Behavioral|fast-track rehabilitation|fast-track rehabilitation with early ambulation and diet after elective colorectal resection
16305691|NCT00606931|Device|Stereo Navigator Accessory to PEM Flex PET Scanner|For patients with suspicious breast abnormalities seen on high resolution PET image, the patients will be biopsied using commercial vacuum biopsy devices (pre-validated to work with Stereo Navigator) using Naviscan's Stereo Navigator (interventional device) for PET image guidance.
16305692|NCT00606905|Biological|Gamimune N or Gamunex 10%|500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
16305693|NCT00606905|Other|normal saline|equivalent volume of normal saline
16305694|NCT00606892|Drug|Varenicline|Varenicline (1 mg per day) given for 4 days prior to laboratory session
16305695|NCT00606892|Drug|Placebo|Sugar Pill
16305696|NCT00606892|Drug|IV Nic|IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.
16305697|NCT00606879|Drug|SGX523 Capsules|This is a dose escalation study
16305698|NCT00606866|Drug|placebo|Placebo for four weeks
16305699|NCT00606866|Drug|Sorafenib|Sorafenib 200 mg twice daily
16305700|NCT00606866|Drug|Sorafenib|Sorafenib, 400 mg twice daily
16305701|NCT00606853|Behavioral|Contingency Management|Rewards valued $1-$100 for abstinence or treatment attendance
16305702|NCT00606840|Behavioral|large changes in eating and activity|Behavioral self-regulation interventions to prevent weight gain in young adults.
16305703|NCT00606840|Behavioral|small changes in eating and activity|Behavioral self-regulation interventions to prevent weight gain in young adults.
16305704|NCT00606827|Drug|Sodium Bicarbonate|Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
16305705|NCT00606827|Drug|Isotonic Saline|Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure
16305706|NCT00606814|Drug|IPI-504, docetaxel|"IPI-504 administered IV at a dose of 300mg/m2
~Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration"
16305707|NCT00606801|Drug|Galantamine|Galantamine 8 mg/day
16305708|NCT00606801|Drug|placebo|sugar pill
16305709|NCT00606788|Device|SmartCare/PS (Automated Weaning)|Patients received computer-driven protocolized weaning
16305710|NCT00606788|Procedure|Conventional weaning|Patients received physician-directed non-protocolized weaning
16305711|NCT00606775|Drug|Carvedilol|2.5-5mg/day
16305712|NCT00606762|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure
16305713|NCT00606749|Drug|KC706|300 mg once daily (QD) for 12 weeks.
16305714|NCT00606723|Biological|Hematopoietic stem cells from bone marrow or peripheral blood|> = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.
16305715|NCT00606710|Device|Cognis 100-D, Teligen DR, VR 100 HE|ICD or CRT - Therapy
16305718|NCT00606684|Drug|GW642444 6.25|GW642444 6.25
16305719|NCT00606684|Drug|GW642444 3mcg|once daily
16305720|NCT00606684|Drug|GW642444 12.5mcg|GW642444 12.5mcg
16305721|NCT00606684|Drug|GW642444 25mcg|GW642444 25mcg
16305722|NCT00606684|Drug|GW642444 50mcg|GW642444 50mcg
16305723|NCT00606684|Other|placebo|placebo
16305724|NCT00606658|Procedure|Shirodhara Oil Treatment|Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
16305725|NCT00606645|Biological|XmAb2513|Intravenous infusion of XmAb2513 administered at a dose of 0.3, 1.0, 3.0, 6.0, 9.0, or 12 mg/kg in sequential dose cohorts.
16305726|NCT00606632|Drug|124-Iodine-cG250 (124I-cG250)|i.v. and PET/CT scan 4+/-2 days after administration
16305727|NCT00606632|Procedure|CT|contrast enhanced CT scan
16305728|NCT00606619|Other|Conventional feeding|Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.
16305729|NCT00606619|Other|Early oral feeding|Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
16305730|NCT00606606|Other|Clinical Decision Support|
16305731|NCT00606593|Drug|ACT-078573 oral capsules at 25 and 100 mg and matching placebo|5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305732|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305733|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305734|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305735|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305736|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305737|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305738|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305739|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305740|NCT00606593|Drug|ACT-078573 and matching placebo|ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
16305741|NCT00606580|Drug|WR 279,396 topical cream|WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
16305742|NCT00606580|Drug|Paromomycin Alone topical cream|The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
16305743|NCT00606580|Drug|Vehicle placebo cream|Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
16305744|NCT00606567|Other|Methods for monitoring patients with ICD's|Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic.
16305745|NCT00606554|Device|Computer-assisted weaning program|Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
16305746|NCT00606554|Behavioral|Standard of Care weaning|Evidence-based standard of care weaning process.
16305747|NCT00606541|Drug|Quetiapine XR|This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).
16305748|NCT00606541|Drug|Placebo|Placebo
16305749|NCT00606528|Other|No intervention|None. This is an observational study.
16305750|NCT00606515|Drug|Liposomal paclitaxel|Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
16305751|NCT00606515|Drug|Paclitaxel|Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
16305752|NCT00606502|Drug|Pralatrexate|"Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).
~Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.
~Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.
~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."
16305753|NCT00606502|Drug|Erlotinib|"150 mg orally in tablet form
~Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met."
16305754|NCT00606502|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment."
16305797|NCT00606138|Drug|ranibizumab|One 0.5 mg intravitreal injection
16306303|NCT00602368|Other|laboratory biomarker analysis|
16305755|NCT00606502|Dietary Supplement|Folic Acid|"1-1.25 mg orally
~Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment."
16305756|NCT00606489|Drug|Caldolor|800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours
16305757|NCT00606489|Drug|Placebo|Placebo
16305758|NCT00606476|Drug|Bapineuzumab (AAB-001)|IV q13w
16305759|NCT00606463|Device|Cardiac Ablation (Gen2 Cardiac Ablation System)|Ablation of isthmus-dependent atrial flutter
16305760|NCT00606450|Drug|CC-10004|20 mg CC-10004 taken 1 time per day for 12 weeks
16305761|NCT00606450|Drug|CC-10004|20 mg of CC-10004 taken 2 times per day for 12 weeks
16305762|NCT00606450|Drug|Placebo|matching placebo taken either 1 or 2 times per day for 12 weeks
16305763|NCT00606437|Procedure|Total Body Irradiation with Fludarabine in UCB Transplants|Administration of the preparative regimen, infusion of the stem cell graft, inpatient care during the immediate post-transplant period and outpatient follow-up for the first 3 months after transplant and at 6, 12, 24 and 36 months. Patients will have human leukocyte antigen (HLA) serologic typing and DNA typing. Bags of UCB are thawed, and diluted by 1:1 volume using a 5% albumin/dextran solution. The thawed and diluted umbilical cord blood unit (UCBU) is next weighed and centrifuged. Specimens are obtained for cell count and viability, culture, clonogenic assays, and phenotype. The UCB is infused at a rate of 1-3 ml/min. Furosemide (0.5-1.0 mg/kg/dose) may be given if volume overload or decreased urine output occurs. Each UCB infusion shall be tested for sterility, CFU content, number of CD34+ cells, cell count and viability.
16305764|NCT00606424|Drug|20 mCi dose for a 50 kg individual of [F-18]HX4|All subjects, normal volunteers and cancer subjects will receive HX4 administered through a previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection, qualified site personnel will assay the dose in the dose calibrator and document the activity of the dose and time of assay. After injection, the line will be flushed with saline (approximately 10 mL).
16305765|NCT00606411|Drug|Topiramate or Placebo|25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
16305766|NCT00606398|Procedure|surgical resection for patients with both intra- and extra-hepatic metastases|Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted
16305767|NCT00606385|Procedure|Liver resection|Laparoscopic or Open hepatectomy
16305768|NCT00606372|Procedure|OPCAB - the off-pump coronary artery bypass|surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart
16305769|NCT00606359|Biological|Inactivated, split-virion influenza virus|0.1 mL, Intradermal. 2 vaccinations 12 months apart
16305770|NCT00606359|Biological|Inactivated, split-virion influenza virus|0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
16305773|NCT00606333|Device|NEVO™ Sirolimus-eluting Coronary Stent System|Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
16305774|NCT00606333|Device|Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)|Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
16305775|NCT00606320|Drug|Aripiprazole|oral, 24mg(4 tablets)/day
16305776|NCT00606307|Drug|ITF2357|50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
16305777|NCT00606294|Radiation|fluorine-18-labeled fluoro-misonidazole (18F-FMISO)|
16305778|NCT00606294|Device|18F-FMISO PET scan|
16305779|NCT00606294|Device|MRI|
16305780|NCT00606294|Device|FDG PET/CT scan|
16305781|NCT00606281|Drug|Aripiprazole|oral, 24mg/day
16305782|NCT00606281|Drug|placebo|oral, 0mg(4tablets)/day
16305783|NCT00606268|Drug|Micafungin|IV
16305784|NCT00606242|Drug|Fluticasone|Inhaled Fluticasone, either 100 or 1000 mcg per day
16305785|NCT00606229|Drug|Aripiprazole|oral, 24mg/day
16305786|NCT00606216|Procedure|MRI and cognitive evaluation|Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.
16305787|NCT00606216|Procedure|MRI and cognitive evaluation|Pt will undergo a Magnetic Resonance Imaging (MRI) study of the brain and a brief neuropsychological evaluation, at the time of enrollment for healthy controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients (Baseline/Time 1).
16305788|NCT00606216|Procedure|brain MRI study and a brief neuropsychological evaluation|A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls
16305789|NCT00606203|Drug|milnacipran|taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression
16305790|NCT00606203|Drug|placebo|placebo
16305791|NCT00606190|Procedure|Retrograde brain perfusion|observational
16305792|NCT00606190|Procedure|Antegrade brain perfusion|observational
16305793|NCT00606177|Drug|Aripiprazole|oral, 24mg(4 tablets)/day
16305794|NCT00606177|Drug|placebo|oral, 0mg(4tablets)/day
16305795|NCT00606164|Drug|Bryostatin for Injection|A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
16305796|NCT00606164|Drug|Placebo|A single one-hour intravenous infusion of placebo on Day 1
16305798|NCT00606138|Procedure|Laser photocoagulation|panretinal photocoagulation (up to 500 300-500 um laser spots)
16305799|NCT00606125|Drug|Nexavar (Sorafenib, BAY43-9006)|The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib.
16305800|NCT00606112|Drug|Trodusquemine (MSI-1436)|A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
16305801|NCT00606099|Drug|telbivudine|To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
16305802|NCT00606099|Drug|adefovir dipivoxil|Active Comparator
16305803|NCT00606086|Drug|GI-5005|40YU, subcutaneous
16305804|NCT00606086|Drug|Pegylated Interferon and Ribavirin|Pegylated interefron is an injection and ribavirin is an oral tablet
16305805|NCT00606073|Other|Universal IVF Medium + ISM1 Medium|Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection. Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance. After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only. The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
16305806|NCT00606060|Drug|Kogenate (BAY14-2222)|100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.
16305807|NCT00606047|Radiation|Magnetic resonance imaging (MRI)|Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
16305808|NCT00606034|Drug|U-500 Insulin delivered by Omnipod (disposable insulin pump)|U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
16305809|NCT00606021|Drug|pemetrexed|500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
16305810|NCT00606021|Drug|Best Supportive Care|Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
16305811|NCT00606008|Drug|Sunitinib Malate|Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
16305812|NCT00605995|Drug|Simvastatin|20 mg taken orally once daily for the first 4 weeks. Dosage will be increased to 40 mg/day at the end of week 4.
16305813|NCT00605982|Procedure|MRI|The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS. Biopsy of any suspicious areas by needle biopsy or at the time of surgery. If appropriate, repeat MRI after biopsy or surgery. Follow-up for 10 years (you will be contacted once a year to see how you are doing).
16305814|NCT00605969|Procedure|Motion analysis|Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.
16305815|NCT00605969|Diagnostic Test|Computed Tomography|Participants will undergo computed tomography (CT) scan of their hip.
16305816|NCT00605956|Drug|NatrOVA Creme Rinse - 1%|NatrOVA Creme Rinse - 1% spinosad
16305817|NCT00605956|Drug|NatrOVA Creme Rinse Vehicle Only|NatrOVA Creme Rinse Vehicle - no spinosad
16305818|NCT00605956|Drug|Blank Patch|Blank Patch
16305819|NCT00605930|Dietary Supplement|Pyruvate, creatine, niacinamide|A bar of 2 gm of pyruvate and 1 gm of creatine, and a pill of 1 gm of niacinamide once a day for 24 weeks.
16305820|NCT00605930|Dietary Supplement|Placebo|25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.
16305821|NCT00605917|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration."
16305822|NCT00605904|Drug|Acamprosate|orally administered tablet, 333mg, three times daily for a minimum of 2 weeks (14 days)
16305823|NCT00605904|Drug|Yohimbine|Intravenous infusion of yohimbine (0.4 mg/kg) administered once over 10 minutes
16305824|NCT00605904|Drug|mCPP|Intravenous infusion of mCPP (0.05 mg/kg) over 10 minutes, two times, for a total of 0.1 mg/kg
16305825|NCT00605904|Drug|Saline|"Intravenous infusion of 0.9% sodium chloride solution over 10 minutes, three times during the study (2 times for the Saline Infusion milestone, and one time immediately following the Yohimbine Infusion milestone)"
16305826|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 2.0 μg once a day, in the morning
~(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)"
16305827|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 1.0 μg once a day, in the morning
~(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))"
16305828|NCT00605891|Drug|carmoterol (CHF 4226)|"carmoterol pMDI 4.0 μg once a day, in the morning
~(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)"
16305829|NCT00605891|Drug|salmeterol|Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
16305830|NCT00605891|Drug|placebo|Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
16305831|NCT00605865|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration."
16305832|NCT00605852|Drug|GSK835726|GSK835726 will be available in single dose and repeat dose formulations.
16305833|NCT00605852|Drug|Placebo|Placebo will be given to subjects.
16305834|NCT00605839|Device|GlucoPak|We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
16305835|NCT00605839|Device|Cell Phone|We will provide cell phones and access to the clinic to facilitate communications
16305836|NCT00605839|Other|Usual Care|This intervention was usual care, without either device.
16305837|NCT00605826|Device|NASHA/Dx (Solesta) Gel|Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
16305838|NCT00605826|Device|Sham Injection|Sham injection at the start of the blinded phase.
16305839|NCT00605813|Drug|Sertraline hydrochloride|"J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan.
~Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms.
~Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration."
16305840|NCT00605800|Other|blood drawn|Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).
16305841|NCT00605800|Other|blood drawn|At the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood. Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top). Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3.
16305842|NCT00605787|Drug|Tetradecylthioacetic acid (TTA)|1000mg capsules once daily for 28 days
16305843|NCT00605774|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infused over two hours during experimental period on Day 2
16305844|NCT00605774|Drug|epinephrine|Epinephrine 0.06 µg/kg/min infusion during hyperinsulinemic euglycemic clamp on day 2
16305845|NCT00605761|Drug|SB656933|50 mg treatment
16305846|NCT00605761|Drug|SB656933|150 mg treatment
16305847|NCT00605748|Procedure|Segmental PV-Isolation of the arrhythmogenic vein(s)|isolation of pulmonary veins for curing atrial fibrillation
16305848|NCT00605748|Procedure|Segmental PV-Isolation of all veins|isolation of pulmonary veins for curing atrial fibrillation
16305849|NCT00605735|Drug|BMS-582949|Tablets, Oral, 300 mg, once daily, 12 weeks
16305850|NCT00605735|Drug|Placebo|Tablets, Oral, placebo, once daily, 12 weeks
16305851|NCT00605722|Drug|bevacizumab (Avastin)|5 mg/kg iv on day 1 of each 2 week cycle.
16305852|NCT00605722|Drug|erlotinib (Tarceva)|150 mg orally (po) daily.
16305853|NCT00605709|Drug|API 31510 Topical Cream|Topical treatments to lesion twice daily of randomized treatments.
16305854|NCT00605696|Drug|Insulin|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.
16305855|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
16305856|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
16305857|NCT00605683|Drug|Safinamide (as add-on therapy)|Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
16305858|NCT00605670|Behavioral|questionnaires|patients will fill out two questionnaires post surgery
16305859|NCT00605670|Behavioral|questionnaires|Patient will fill out questionnaire before and 3 to 6 months after treatment.
16305860|NCT00605657|Drug|Valproic Acid|Oral administration of valproic acid
16305861|NCT00605657|Procedure|CT Scan|CT scans were done before and after treating the patient with valproic acid
16305862|NCT00605657|Procedure|Blood Sample|Blood samples were collected before and after the intervention to monitor blood counts and biomarkers of ALPS
16305863|NCT00605644|Drug|MOA-728|Oral Capsules
16305864|NCT00605644|Drug|Placebo|Placebo
16305865|NCT00605631|Device|Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System|No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
16305866|NCT00605618|Drug|BMS-777607|Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation
16305867|NCT00605605|Drug|Dextromethorphan|120 mg/day, single once daily dose taken after breakfast by oral route
16305868|NCT00605592|Procedure|Pancreatic Islets of Langerhans Cell Transplant|Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
16305869|NCT00605566|Drug|Sorafenib|"During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
16305916|NCT00605176|Drug|imiquimod cream|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
16305917|NCT00605176|Drug|imiquimod cream|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
16305870|NCT00605566|Drug|Cyclophosphamide|"During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After run-in period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally."
16305871|NCT00605553|Drug|Placebo|"Placebo oral capsules
~Placebo for 7 days"
16305872|NCT00605553|Drug|Tozadenant|20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
16305873|NCT00605514|Drug|VRC-EBODNA023-00-VP|
16305874|NCT00605514|Drug|VRC-MARDNA025-00-VP|
16305875|NCT00605488|Procedure|novel PET tracer FACBC|Two IV catheters (heplock) will be placed in your forearms for injection of the dye-like material (FACBC) and blood sampling. An IV blood sample and a urine sample will be taken for testing. These samples will be used to measure the dye, FACBC, in blood and urine. You will be placed in the PET machine, where FACBC will be injected slowly over 30 seconds. Pictures of one region of your body will be taken for up to 60 minutes. Depending on your condition, your actual picture time may be shorter. You will come out of the scanner to stretch, walk around or sit in a chair. An optional urine sample and an IV blood sample will also be taken at this time. Again, these samples will be used to measure the dye, FACBC, in blood and urine. This will be followed by a picture of your body from the neck to the upper thighs. This picture will take about 30 minutes.
16305876|NCT00605475|Drug|Canakinumab|Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
16305877|NCT00605475|Drug|Placebo|Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
16305878|NCT00605475|Drug|Metformin|Participants continued on their stable daily dose of metformin throughout the study
16305879|NCT00605449|Drug|GSK376501|
16305880|NCT00605436|Behavioral|Restorative yoga therapy|3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.
16305881|NCT00605423|Drug|Fluocinolone Acetonide/Medidur|0.2 ug/day implant
16305882|NCT00605423|Drug|Fluocinolone Acetonide/Medidur|0.5 ug/day implant
16305883|NCT00605410|Drug|ipratropium bromide|2 puffs (40 micrograms) 2 puffs (0micrograms)
16305884|NCT00605410|Drug|placebo|Matched placebo
16305885|NCT00605397|Radiation|PET Imaging With Cu-64 Labeled Trastuzumab|The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.
16305886|NCT00605397|Radiation|PET Imaging With Cu-64 Labeled Trastuzumab|The remaining 20 patients will undergo one PET study.
16305887|NCT00605384|Drug|Entecavir + Tenofovir|Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
16305888|NCT00605384|Drug|Adefovir + continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
16305889|NCT00605371|Drug|Lamotrigine tablet|Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.
16305890|NCT00605371|Drug|Lamotrigine caplet|Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.
16305891|NCT00605358|Behavioral|Open Door intervention|"Open Door intervention subjects will:
~receive an evaluation
~receive a referral to a local mental health provider
~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
16305892|NCT00605345|Drug|Darbepoetin alfa|As prescribed
16305893|NCT00605345|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc 4-weekly (starting dose)
16305894|NCT00605332|Device|inferior vena cava filter|Crux Biomedical IVC Filter
16305895|NCT00605319|Drug|Toviaz (Fesoterodine)|4mg to 8mg by mouth once daily
16305896|NCT00605306|Drug|indacaterol maleate / mometasone furoate|Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
16305897|NCT00605306|Drug|placebo to indacaterol maleate/mometasone furoate|Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
16305898|NCT00605293|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms iv/month (starting dose)
16305899|NCT00605293|Drug|Epoetin alfa|As prescribed
16305900|NCT00605280|Drug|Standard of Care|Clinicians decision to use optional laser therapy.
16305901|NCT00605280|Drug|Macugen|Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
16305902|NCT00605267|Drug|Tamoxifen|20 mg once daily oral dose
16305903|NCT00605267|Drug|Anastrazole (Arimidex)|1 mg once daily oral dose
16305904|NCT00605267|Drug|Goserelin acetate (Zoladex)|3.6mg/month depot injection
16305905|NCT00605241|Drug|GSK598809|Drug
16305906|NCT00605228|Drug|MOVIPREP|2L Drug
16305907|NCT00605228|Drug|COLOPEG|4L Drug
16305908|NCT00605215|Drug|laquinimod|0.6 mg oral once daily for 24 months
16305909|NCT00605215|Drug|placebo|oral placebo once daily for 24 months
16305910|NCT00605215|Drug|Interferon β-1a (Avonex®)|Interferon β-1a (Avonex®) 30 mcg IM once weekly for 24 months
16305911|NCT00605202|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg a day for 14 days.
16305912|NCT00605202|Dietary Supplement|Licorice|Licorice candy 32 grams a day for 14 days.
16305913|NCT00605189|Device|Powered Suction Pump (VAC Freedom)|continuous foam based negative pressure wound therapy
16305914|NCT00605189|Device|Powered Suction Pump|continuous gauze based negative pressure wound therapy
16305915|NCT00605189|Device|MWT|moist wound therapy
16306004|NCT00604487|Device|AID (Atad double balloon Instillation Device)|Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour
16305918|NCT00605176|Drug|Placebo|cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
16305919|NCT00605150|Radiation|TheraSphere-Yttrium 90 microsphere|TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.
16305920|NCT00605137|Drug|insulin detemir|
16305921|NCT00605137|Drug|insulin NPH|
16305922|NCT00605124|Other|Knee muscle exercises|Home exercises three times a week, control every three months
16305923|NCT00605111|Drug|biphasic insulin aspart|
16305924|NCT00605098|Drug|Lopinavir / ritonavir|Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation and maintained for at least 6 weeks after delivery.
16305925|NCT00605098|Drug|Lopinavir/ritonavir|Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation, increase the lopinavir/r dosage (200/50 mg, 3 tablets every 12 hours) in the third trimester (from 25 weeks on), and return to standard dose(200/50 mg, 2 tablets every 12 hours)for at least 6 weeks after delivery.
16305926|NCT00605085|Biological|Japanese Encephalitis purified inactivated vaccine (IC51)|IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
16305927|NCT00605085|Biological|Placebo|Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
16305928|NCT00605072|Drug|candesartan|orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months
16305929|NCT00605072|Drug|lisinopril|orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months
16305930|NCT00605072|Drug|hydrochlorothiazide|orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months
16305931|NCT00605072|Drug|nifedipine, long acting|If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments
16305932|NCT00605072|Drug|metoprolol, long-acting|If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg
16305933|NCT00605059|Drug|[123I]AV94|Evaluation of [123I] AV94 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
16305934|NCT00605046|Drug|SPECT scan|AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
16305935|NCT00605033|Drug|Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484|Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
16305936|NCT00605033|Drug|Subutex, Buprenorphine Hydrochloride, SCH 28444|Subutex sublingual tablet 4-24 mg, daily for 28 days
16305937|NCT00605020|Drug|insulin detemir|
16305938|NCT00605020|Drug|insulin aspart|
16305939|NCT00605020|Device|biphasic insulin aspart|
16305940|NCT00604981|Behavioral|Multisystemic Therapy (MST)|MST is an intensive, family centered, community based treatment originally designed for use with adolescents presenting with serious mental health problems. In this study, MST interventions are aimed at increasing adolescent and family adherence to dietary and exercise recommendations and targeting barriers within the family system, and the broader community systems within which the family is embedded (peers, schools, health care). Decreasing caloric consumption consistent with recommended intake targets, increasing daily exercise and decreasing sedentary activity, are treatment focuses depending on whether the adolescent has difficulty with this aspect of weight management or not.
16305941|NCT00604981|Behavioral|Shapedown|Shapedown, is a clinic-based, adolescent weight loss intervention. Shapedown utilizes psycho educational, behavior, and family therapy techniques in a 10-week group intervention. In order to match MST's length of intervention (6 months), three follow-up sessions are added at monthly intervals.
16305942|NCT00604968|Drug|Caelyx (pegylated liposomal doxorubicin; SCH 200746)|Caelyx will be administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
16305943|NCT00604955|Drug|Paromomycin sulfate|Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
16305944|NCT00604942|Procedure|Heller's Myotomy|Long vs Short Heller's Myotomy for Achalasia
16305945|NCT00604942|Procedure|Nissen Fundoplication|Partial vs Full Fundoplication for GORD
16305946|NCT00604942|Drug|domperidone or esomeprazole (Conservative management)|Conservative management for dysphagia not referred for surgery. Conservative management: balloon dilatation or drugs such as domperidone 10 mg or esomeprazole 40 mg
16305947|NCT00604942|Drug|Esomeprazole 40 mg|Esomeprazole vs no esomeprazole for GORD not referred for surgery
16305948|NCT00604929|Dietary Supplement|carbohydrate and protein|The intake of carbohydrate and protein during endurance type exercise
16305949|NCT00604916|Other|standardized oral care protocol - electronic toothbrush|a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.
16305950|NCT00604916|Other|mimic protocol|a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.
16305951|NCT00604903|Device|Implant of Pressure sensor.|Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
16305952|NCT00604890|Drug|API 31510 3% Topical Cream|Topical treatment 3% active cream applied to the lesion
16305953|NCT00604890|Drug|API 31510 1.5% Topical Cream|Topical treatment 1.5% active cream applied to the lesion
16305954|NCT00604890|Other|Placebo|Topical treatment placebo applied to the lesion
16305955|NCT00604877|Behavioral|Treadmill Exercise|3 times per week for 6 months, with target of 45 minutes at 60-70% heart rate range
16305956|NCT00604877|Behavioral|Stretching/ROM|3 times per week for 6 months, passive and active stretching and range of motion (ROM) exercises for the upper and lower extremities
16306005|NCT00604487|Device|folly catheter|folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
16305957|NCT00604864|Drug|anti TNFa monoclonal antibody - Infliximab|Chimeric A2 (infliximab, RemicadeTM) IgG ; 100 mg infliximab IgG, Infliximab was freshly prepared immediately before each administration. Infliximab or placebo was administered as a slow infusion of 250mL on weeks 0, 2 and 6. Women were closely observed during, and for 1 hour after, the infusion in the event of any serious adverse reactions.
16305958|NCT00604864|Drug|placebo|Placebo
16305959|NCT00604838|Device|AL-SENSE Diagnostic Absorbent Panty liner|worn for 12 hours
16305960|NCT00604838|Device|AL-SENSE Diagnostic Absorbent Panty liner|Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours
16305961|NCT00604825|Drug|Other: Placebo|
16305962|NCT00604825|Drug|GSK232802|
16305963|NCT00604825|Drug|PREMARIN|
16305964|NCT00604812|Drug|rizatriptan benzoate (5 mg)|A single dose of rizatriptan 5 mg administered on Day 1.
16305965|NCT00604812|Drug|rizatriptan benzoate (10 mg)|A single dose of rizatriptan 10 mg administered on Day 1.
16305966|NCT00604812|Drug|Rizatriptan 5 mg Placebo|A single dose of rizatriptan 5 mg placebo administered on Day 1.
16305967|NCT00604812|Drug|Rizatriptan 10 mg Placebo|A single dose of rizatriptan 10 mg placebo administered on Day 1.
16305968|NCT00604799|Device|Talent Thoracic Stent Graft|TEVAR
16305969|NCT00604786|Drug|omalizumab|Dosing is based on IgE level and weight given every 2 or 4 weeks
16305970|NCT00604786|Drug|placebo|Dosing is based on IgE level and weight given every 2 or 4 weeks
16305971|NCT00604760|Drug|MEM 3454|Capsule 5 mg once a day
16305972|NCT00604760|Drug|MEM 3454|Capsule 15 mg once a day
16305973|NCT00604760|Drug|MEM 3454|Capsule 50 mg once a day
16305974|NCT00604760|Drug|Placebo for MEM 3454|Capsule once a day
16305975|NCT00604747|Other|Structure practice|there were 2 groups which received random practice and constant practice during acquisition phase
16305976|NCT00604734|Device|ReCap Total Hip Resurfacing System|This is a hip resurfacing system.
16305977|NCT00604721|Drug|selumetinib|Given orally
16305978|NCT00604721|Other|pharmacological study|
16305979|NCT00604708|Biological|IC51|IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
16305980|NCT00604708|Biological|JE-VAX|JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28
16305981|NCT00604695|Drug|Tenecteplase|Intracoronary injection of IV tenecteplase.
16305982|NCT00604695|Drug|Sterile Saline|Intracoronary injection of IV sterile saline
16305983|NCT00604682|Drug|CC10004|2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
16305984|NCT00604656|Drug|insulin aspart|
16305985|NCT00604643|Device|TALENT Aortic Cuff Abdominal Stent Graft|Endovascular Aneurysm Repair
16305986|NCT00604630|Drug|recombinant human erythropoietin alfa|40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
16305987|NCT00604630|Drug|0.9% NaCl|50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
16305988|NCT00604617|Procedure|Interferon-Gamma Release Assay|IGRAs
16305989|NCT00604617|Drug|RT-23|TST - tuberculin skin test
16305990|NCT00604604|Behavioral|Peer support|Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received telephone-based support from a peer volunteer (a mother who has previously experienced, and recovered from, postpartum depression and has participated in a 4-hour training session). Telephone contact with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.
16305991|NCT00604591|Drug|Tolcapone|200 mg by mouth three times a day
16305992|NCT00604591|Drug|Placebo|200 mg by mouth three times a day
16305993|NCT00604578|Drug|Pioglitazone Hydrochloride|
16305994|NCT00604565|Drug|soluble ferric pyrophosphate (SFP)|"Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).
~Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)"
16305995|NCT00604565|Other|placebo|Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
16305997|NCT00604539|Drug|Chondroitin sulphate (Condrosan)|800 mg (two capsules of 400 mg each) taken once a day for one year
16305998|NCT00604539|Drug|Placebo|Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day
16305999|NCT00604526|Radiation|High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds|"Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL
~*After 1 year, will follow up with doctor about every 6 months."
16306000|NCT00604513|Other|Ready. Set. ACTION! Protocol|"The intervention included three components: theater sessions; booster sessions; and family outreach. After-school theater sessions were conducted in the fall in the intervention schools. Sessions included: a check-in about changes made over the past week; healthy snacks; a movement component that involved fun and easy activities; and creating/education. Children at intervention schools participated in weekly after-school booster sessions in the winter to further address the behavioral messages addressed during the intervention. Throughout the program, weekly Fun & Fitness packs were sent home to families that included a healthy food with a simple recipe using that food or fitness incentives for the family. There were also two family events: a theater performance, and a reception."
16306001|NCT00604513|Other|Control|The control condition also participated in a theater-based intervention that addressed a health topic unrelated to weight, hand-washing and overall personal hygiene.
16306002|NCT00604500|Drug|SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.
16306003|NCT00604487|Device|ARD (Atad Ripener Device)|Atad double balloon ripener device
16306006|NCT00604474|Device|HiResolution Bionic Ear System (Cochlear Implant)|Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
16306007|NCT00604461|Drug|Carboplatin, Bevacizumab and Pemetrexed|Chemotherapy was given for 2 cycles after maximal response. Patients were taken off study at the time of progression. If the patient had stable disease or better, as a response, then the patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first. Computed tomography (CT) scans were be done every 12 weeks during the maintenance phase.
16306008|NCT00604448|Other|Dietary advise|Subjects in energy-restricted group will follow dietician advise to keep a conventional energy restriction diet.
16306009|NCT00604448|Other|Diet enriched with a meal containing pulses|Subjects in pulse group will consume the commercially available pulses for 8 weeks
16306010|NCT00604435|Drug|docetaxel and epirubicin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
16306011|NCT00604435|Drug|docetaxel and epirubicin plus endostatin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
16306012|NCT00604409|Radiation|SIRT|Undergo SIRT
16306013|NCT00604409|Drug|capecitabine|Given PO
16306014|NCT00604396|Drug|insulin detemir|
16306015|NCT00604396|Drug|insulin NPH|
16306016|NCT00604383|Drug|ruboxistaurin|32-mg tablet, orally, daily, up to 42 months
16306017|NCT00604383|Drug|placebo|1 tablet, orally, daily, up to 42 months
16306018|NCT00604357|Drug|anti-CD 25 mAb, Sirolimus, MMF|"Prior to reperfusion: 500 mg Prednisolone After OLT: anti-CD25-mAB (basiliximab 20 mg on day 0 and day 4 after the procedure)
~MMF 2 g/d, 2 applications per day i.v., later conversion to oral intake)
~Earliest, on day 10 after LT Sirolimus: 5 mg/d, thereafter a dosage of 2 mg/d (4 and 8 ng/mL)
~Steroids: 1mg/kg BW (tapered every 2 days for 5 mg to a dosage of 20 mg, 2.5 mg every two days to 7.5 mg, reduced to 5 mg and 2.5 mg for 1 week each and eliminated thereafter)."
16306019|NCT00604344|Drug|insulin detemir|
16306020|NCT00604344|Drug|insulin NPH|
16306021|NCT00604331|Drug|Pyruvate|sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.
16306022|NCT00604318|Drug|rhTSH|The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
16306023|NCT00604305|Device|Acrysof|Monofocal IOL
16306024|NCT00604305|Device|Acuity's AIOL|Accommodating IOL
16306025|NCT00604279|Drug|Paliperidone palmitate (R092670)|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
16306026|NCT00604279|Drug|Risperidone|Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
16306027|NCT00604253|Drug|insulin detemir|
16306028|NCT00604253|Drug|insulin NPH|
16306029|NCT00604227|Other|Hypoxic Exposure|ascent to 4559 m within 24 h without prior acclimatization
16306030|NCT00604214|Drug|Drotrecogin alfa (activated)|24 microgram/kilogram/hour, intravenous, 96 hours (hr)
16306031|NCT00604214|Drug|Placebo|0.9% sodium chloride, intravenous, 96 hours
16306032|NCT00604201|Biological|Umbilical Cord Blood|unrelated umbilical cord blood will be co-infused with haploidentical CD34-selected cells from a related donor for treatment of severe aplastic anemia and myelodysplastic syndrome.
16306033|NCT00604188|Drug|Suboxone (SCH 000484)|2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
16306034|NCT00604188|Drug|Subutex (SCH 028444)|2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
16306035|NCT00604175|Biological|Quadrivalent HPV vaccine|Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
16306036|NCT00604162|Device|PillCam COLON|The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
16306037|NCT00604162|Procedure|Standard colonoscopy|Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
16306038|NCT00604136|Biological|tumor infiltrating lymphocytes|Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro. Tumor infiltrating lymphocytes from these cultures will be assessed for tumor reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x2 days IV)and fludarabine (25 mg/mE2/day IV x5days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 10E9 tumor-reactive lymphocytes followed by high dose IL-2 (720,000 IU/kg/dose IV every 8 hours for up to 15 doses).
16306039|NCT00604123|Drug|JNJ-17166864|JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.
16306040|NCT00604123|Drug|Placebo|Placebo nasal spray twice daily for 2 weeks.
16306041|NCT00604110|Other|Biventricular pacing post cardiac surgery|Determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF<45%), is hemodynamically favourable.
16306042|NCT00604097|Behavioral|Attachment-Based Family Therapy|12-16 week family-based therapy
16306043|NCT00604097|Behavioral|Enhanced Usual Care|Rapid referral to community outpatient care with weekly monitoring of symptoms by study team
16306044|NCT00604084|Drug|Ivermectin|Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months
16306045|NCT00604084|Drug|Permethrin 5% lotion|apply lotion to entire body, excluding head, at bedtime, rinse off following morning, wait one week, repeat application for a total of 2 applications, PRN frequency, NMT 6 applications in 12 months, total duration = 12 months.
16306046|NCT00604058|Biological|Inactivated Poliomyelitis vaccine (IMOVAX)|Fractional dose (1/5th) 0.1 mL, intradermally
16306047|NCT00604058|Biological|Inactivated Poliomyelitis vaccine (IMOVAX)|A full dose, 0.5 mL, intramuscular
16306048|NCT00604045|Behavioral|Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
16306049|NCT00604045|Behavioral|Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
16306050|NCT00604032|Drug|Atralin (tretinoin) Gel, 0.05%|Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.
16306051|NCT00604019|Drug|Dopamine|Dopamine 5-20 mcg/kg/min to pre-determined max of 20
16306052|NCT00604019|Drug|Norepinephrine|Norepinephrine 5-20 mcg/min, to a pre-determined max of 20
16306053|NCT00604006|Drug|Spironolactone|25 mg tablets (placed in capsules for blinding) once daily.
16306054|NCT00604006|Drug|Placebo|Placebo (lactose in capsules for blinding) once daily
16306055|NCT00603993|Biological|Adalimumab|40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
16306056|NCT00603980|Drug|Inhaled placebo + oral placebo|Inhaled Staccato placebo + oral placebo
16306057|NCT00603980|Drug|Inhaled alprazolam 0.5 mg|Inhaled Staccato alprazolam 0.5 mg + oral placebo
16306058|NCT00603980|Drug|Inhaled alprazolam 1 mg|Inhaled Staccato alprazolam 1 mg + oral placebo
16306059|NCT00603980|Drug|Inhaled alprazolam 2 mg|Inhaled Staccato alprazolam 2 mg + oral placebo
16306060|NCT00603980|Drug|Oral alprazolam 1 mg|Oral alprazolam 1 mg + Inhaled placebo
16306061|NCT00603980|Drug|Oral alprazolam 2 mg|Oral alprazolam 2 mg + Inhaled placebo
16306062|NCT00603980|Drug|Oral alprazolam 4 m|Oral alprazolam 4 mg + Inhaled placebo
16306063|NCT00603980|Drug|Oral alprazolam 2 mg qualifying session|Qualifying session (2 mg oral alprazolam)
16306064|NCT00603980|Drug|Oral placebo qualifying session|Qualifying control session (oral placebo)
16306065|NCT00603967|Procedure|Dual x-ray absorptiometry (DXA)|Baseline, 6 months, and 12 months
16306066|NCT00603967|Procedure|Blood draw|Baseline - genotyping Baseline, 6 months, and 12 months - markers of bone turnover and hormonal assays
16306067|NCT00603967|Behavioral|Questionnaire|"Menopausal symptom questionnaire - baseline, 3 months, 6 months, 12 months
~Cognitive tests - baseline, 6 months, 12 months
~Depression assessment - baseline, 6 months, 12 months
~Dietary calcium intake questionnaire - baseline"
16306068|NCT00603954|Drug|Conditioning regimen TBI + Fludarabine|2 Gy TBI, Fludarabine 90 mg/m²
16306069|NCT00603954|Drug|Conditioning regimen II (TLI 8 Gy + ATG [Thymoglobulin])|TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg
16306070|NCT00603941|Drug|CS-7017|At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D).
16306071|NCT00603941|Drug|Paclitaxel|Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.
16306072|NCT00603915|Drug|Gemcitabine|1000mg/m^2 intravenous (IV) day 1 and day 8
16306073|NCT00603915|Drug|Carboplatin/Cisplatin|Area under curve (AUC)=5 (Carboplatin) or 70mg/m^2 (Cisplatin) intravenous (IV) day 1
16306074|NCT00603915|Drug|erlotinib|150mg daily (post GC therapy)
16306075|NCT00603902|Drug|Lorcaserin 10 mg once daily (QD)|Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
16306076|NCT00603902|Drug|Lorcaserin 10 mg twice a day (BID)|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
16306077|NCT00603902|Drug|Matching Placebo|Matching placebo tablet each morning and evening for a duration of 52 weeks.
16306078|NCT00603889|Biological|Na-ASP-2 Skin Test Reagent|Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
16306079|NCT00603876|Dietary Supplement|Almonds|100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
16306080|NCT00603863|Biological|IMMU-107 (hPAM4)|90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
16306081|NCT00603850|Device|ForeseeHome|human factor
16306082|NCT00603837|Device|NeoWrap|This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
16306083|NCT00603837|Device|InfaTherm|A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
16306084|NCT00603824|Drug|fondaparinux|fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
16306085|NCT00603824|Drug|argatroban or lepirudin|continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
16306086|NCT00603811|Biological|VAX102 [Flagellin.HuM2e]|dose ranging, 2 i.m. doses given 28 days apart
16306087|NCT00603811|Biological|Placebo|Placebo
16306088|NCT00603798|Drug|Imiquimod cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
16306135|NCT00603434|Drug|OROS-MPH|27mg bid on days 3 and 4
16306136|NCT00603434|Drug|OROS-MPH|35 mg bid on days 5-9
16306190|NCT00603018|Drug|Fluoxetine|8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
16306089|NCT00603798|Drug|Placebo cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
16306090|NCT00603798|Drug|Imiquimod cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
16306091|NCT00603785|Drug|Placebo|Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive placebo treatment for 6 months.
16306092|NCT00603785|Drug|Xolair|Subjects with chronic sinusitis and evidence of atopy and an elevated total IgE (>30 and <700 IU/ml) will be randomized to receive Xolair treatment for 6 months.
16306093|NCT00603772|Drug|Atralin (tretinoin) gel, 0.05%|Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.
16306094|NCT00603759|Drug|celecoxib|100 mg qid
16306095|NCT00603759|Drug|placebo|1 cap qid
16306096|NCT00603746|Drug|GW685698X|GW685698X
16306097|NCT00603733|Drug|5-ASA (5-Aminosalicylate)|500 mg tablet (modified extended release)
16306098|NCT00603733|Drug|5-ASA (5-Aminosalicylate)|500 mg tablet
16306099|NCT00603720|Drug|L-NAME|nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging
16306100|NCT00603720|Drug|L-Arginine|aids in nitric oxide production
16306101|NCT00603720|Drug|Phenylephrine|alpha agonist; 10 μg/kg/min infusion during PET study
16306102|NCT00603681|Drug|Polyethylene glycol 4000|powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
16306103|NCT00603681|Drug|Polyethylene glycol 4000 with electrolytes|granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
16306104|NCT00603668|Biological|milatuzumab|two or three times a week dosing of hLL1 for a total of 4 weeks
16306105|NCT00603655|Other|Low glycemic load diet|Low glycemic load diet
16306106|NCT00603655|Other|High glycemic load diet|High glycemic load diet
16306107|NCT00603642|Drug|Placebo|Subcutaneously administered, once a week, for 12 weeks
16306108|NCT00603642|Drug|AMG 531|Subcutaneously administered, once a week, for 12 weeks
16306109|NCT00603616|Drug|Placebo Comparator|Matching oral placebo pills to be taken twice daily for a total of 8 weeks
16306110|NCT00603616|Drug|Rifaximin|Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks
16306111|NCT00603603|Other|80% inhaled oxygen via non-rebreather mask|Patients randomized to treatment group will receive 80% inhaled oxygen via a non-rebreather face mask during their cesarean section and for 2 hours afterwards.
16306112|NCT00603603|Other|30% inhaled oxygen via nasal cannula|Patients randomized to treatment group will receive 30% inhaled oxygen via a nasal cannula (standard of care)during their cesarean section.
16306113|NCT00603590|Drug|Polypill|Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily
16306114|NCT00603590|Drug|Placebo drug|Inactive tablet Once a day Identical in appearance to intervention drug
16306115|NCT00603577|Drug|Placebo|Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
16306116|NCT00603577|Drug|Xaliproden|1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
16306117|NCT00603564|Procedure|Castar Starmed (CPAP) delivered by a helmet|Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
16306118|NCT00603538|Drug|CP-751,871 + carboplatin + paclitaxel|Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.
16306119|NCT00603525|Drug|Ofatumumab|1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each treatment cycle consisting of two IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period
16306120|NCT00603525|Drug|Placebo|1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
16306121|NCT00603512|Drug|Placebo|0 mg BID, 3 blinded tablets administered BID for 12 weeks
16306122|NCT00603512|Drug|CP-690,550|10 mg BID, 3 blinded tablets administered BID for 12 weeks
16306123|NCT00603512|Drug|CP-690,550|1 mg BID, 3 blinded tablets administered BID for 12 weeks
16306124|NCT00603512|Drug|CP-690,550|3 mg BID, 3 blinded tablets administered BID for 12 weeks
16306125|NCT00603512|Drug|CP-690,550|5 mg BID, 3 blinded tablets administered BID for 12 weeks
16306126|NCT00603499|Dietary Supplement|Magnesium chloride|Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.
16306127|NCT00603499|Other|Placebo|Subjects in the control group received inert placebo once per day during 4 months
16306128|NCT00603486|Device|GE DINAMAP with SuperSTAT algorithm monitor|Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)
16306129|NCT00603473|Drug|gabapentin|Orally administered gabapentin
16306130|NCT00603460|Biological|DCVax-L and T Cells|"Arm A
~Optional DCVax-L prior to chemotherapy
~Apheresis
~Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)
~Infusion of activated T cells
~DCVax-L vaccine
~End of study visit
~Arm B
~Optional DCVax-L prior to chemotherapy
~Apheresis
~Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide)
~Infusion of activated T cells
~DCVax-L vaccine
~Oral cyclophosphamide (one week on/one week off) for a total for a total of 6 weeks
~End of study visit"
16306131|NCT00603447|Drug|Carfilzomib|Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area.
16306132|NCT00603447|Drug|Lenalidomide|Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle.
16306133|NCT00603447|Drug|Dexamethasone|Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.
16306134|NCT00603434|Drug|OROS-MPH|18 mg bid on days 1 and 2
16306137|NCT00603421|Other|24 hour phone line|24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder
16306138|NCT00603421|Other|treatment as usual|Treatment as usual
16306139|NCT00603408|Drug|Cisplatin|
16306140|NCT00603408|Radiation|Radiation Therapy|
16306141|NCT00603408|Procedure|Mastectomy|(RECOMMENDED BUT NOT REQUIRED)
16306142|NCT00603395|Device|ReCap Total Hip Resurfacing System|This is a hip resurfacing system.
16306143|NCT00603382|Drug|GW685698X|GW685698X
16306144|NCT00603382|Drug|Placebo|placebo comparator
16306145|NCT00603369|Behavioral|group intervention|13-session intervention
16306146|NCT00603369|Behavioral|group intervention|2-session intervention
16306147|NCT00603356|Drug|OSI-930 and erlotinib|OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
16306148|NCT00603343|Drug|Mictonetten 5 mg, coated tablet|propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
16306149|NCT00603343|Drug|placebo|placebo corresponding to body weight
16306150|NCT00603330|Biological|Mesenchymal stem cells|Mesenchymal Stem Cell infusion
16306151|NCT00603317|Drug|Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo|Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily
16306152|NCT00603317|Drug|Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid|Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days
16306153|NCT00603304|Drug|Saw Palmetto - first 24 weeks|Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
16306154|NCT00603304|Drug|Placebo - first 24 weeks|Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
16306155|NCT00603304|Drug|Saw Palmetto - weeks 24 - 48|Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
16306156|NCT00603304|Drug|Placebo - weeks 24 - 48|Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
16306157|NCT00603304|Drug|Saw Palmetto - weeks 48 - 72|Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
16306158|NCT00603304|Drug|Placebo - weeks 48 - 72|Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
16306159|NCT00603291|Drug|Lorcaserin 10 mg once daily (QD)|Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
16306160|NCT00603291|Drug|Lorcaserin 10 mg twice a day (BID)|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
16306161|NCT00603291|Drug|Matching Placebo|Matching placebo tablet each morning and evening for a duration of 52 weeks.
16306162|NCT00603278|Drug|GW685698X|GW685698X
16306163|NCT00603278|Drug|placebo|placebo
16306164|NCT00603265|Drug|ADL5859|
16306165|NCT00603265|Drug|Duloxetine|
16306166|NCT00603265|Drug|Placebo|
16306167|NCT00603252|Biological|Twinrix|
16306168|NCT00603252|Biological|Engerix-B|
16306169|NCT00603252|Biological|Havrix|
16306170|NCT00603252|Biological|HBVAXPRO|
16306171|NCT00603252|Biological|Vaqta|
16306172|NCT00603239|Drug|exenatide|subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
16306173|NCT00603239|Drug|placebo|subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
16306174|NCT00603213|Procedure|Blood Volume Analysis, Echocardiogram|"Blood Volume Analysis: The use of radioactive tracer to determine plasma volume and red cell mass.
~Echocardiogram is an ultrasound of the heart."
16306175|NCT00603187|Drug|Acyline|20 mg GIPET enhanced oral dose, daily for 7-days
16306176|NCT00603174|Device|neurally adjusted ventilatory assist (NAVA)|Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.
16306177|NCT00603135|Drug|first-line i/v-levetiracetam|No effect after 30 min, standard therapy with f.e. lorazepam for NCSE
16306178|NCT00603122|Behavioral|ascent protocol|ascent protocol for the two groups has different acclimatization time
16306179|NCT00603109|Drug|rimonabant|rimonabant capsule 20 mg per day PO for 6 months
16306180|NCT00603109|Drug|placebo|Subjects take 20 mg placebo capsule one a day PO for 6 months
16306181|NCT00603096|Device|GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare|The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
16306182|NCT00603083|Drug|Ropivacaine, Ketorolac and Adrenalin|The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
16306183|NCT00603083|Drug|Placebo|This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.
16306184|NCT00603070|Other|E-prescribing system|Transition from home-grown to vendor-based ambulatory e-prescribing systems
16306185|NCT00603070|Other|Electronic transmission of medication discharge lists|Patient discharge medication lists will be transmitted upon discharge from their inpatient medical record to their outpatient medical record and their outpatient provider will be notified of this transmission.
16306186|NCT00603044|Drug|fluticasone furoate|treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
16306187|NCT00603031|Other|glucagon like peptide -1|continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
16306188|NCT00603031|Other|NaCl|infusion with NaCl for 120 minutes as placebo-arm
16306189|NCT00603031|Other|glucose dependent insulinotropic polypeptide|continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.
16306299|NCT00602407|Drug|Cilostazol|
16306191|NCT00603005|Device|Use of TravAlert dosing aid with or without drop guider|Each patient will use a dosing aid and/or drop guider for 6 months
16306192|NCT00602979|Device|Macintosh laryngoscope|Used during laryngoscopy to facilitate intubation.
16306193|NCT00602979|Device|Airtraq® Optical Laryngoscope|Used during laryngoscopy to facilitate intubation.
16306194|NCT00602979|Device|Storz DCI Video Laryngoscope®|Used during laryngoscopy to facilitate intubation
16306195|NCT00602979|Device|GlideScope® Video Laryngoscope|Used during laryngoscopy to facilitate intubation
16306196|NCT00602979|Device|McGRATH® Video Laryngoscope|Used during laryngoscopy to facilitate intubation
16306197|NCT00602953|Other|No intervention planned.|This is a cross-sectional observational study, no intervention is planned.
16306198|NCT00602940|Procedure|Acupuncture|12 treatments over 8 weeks
16306199|NCT00602940|Procedure|Sham Acupuncture|12 treatments over 8 weeks
16306200|NCT00602927|Drug|Varenicline|Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
16306201|NCT00602927|Drug|Placebo|Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
16306202|NCT00602914|Device|MicronJet|The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.
16306203|NCT00602914|Device|MicronJet|MicronJet, Intradermal Injection
16306204|NCT00602901|Other|HVLA-SM|High-velocity low amplitude spinal manipulation (HVLA-SM)
16306205|NCT00602901|Other|LVVA-SM|Low-velocity variable amplitude spinal manipulation (LVVA-SM)
16306206|NCT00602901|Drug|Usual medical care|Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.
16306207|NCT00602862|Drug|Sorafenib|Sorafenib 200 mg 2dd2 po for 4 weeks before surgery
16306208|NCT00602862|Drug|111Indium-bevacizumab|100 MBq / 1 mg 111Indium/bevacizumab iv
16306209|NCT00602862|Drug|111Indium-cG250|100 MBq / 10 mg 111Indium-cG250 iv
16306210|NCT00602849|Drug|Sertraline|
16306211|NCT00602836|Biological|Rituximab|Cycle 1: 100 mg by IV on day 1, 375 mg/m^2 by IV on day 2 Cycle 2-6: 375 mg/m^2 by IV on day 1 (every 21 days)
16306212|NCT00602836|Drug|Cyclophosphamide|600 mg/m^2 by IV on day 1 of cycles 1-6 (every 21 days)
16306213|NCT00602836|Drug|Lenalidomide|Cycle 7: 5 mg orally daily on days 1-28 Cycle 8: 10 mg orally daily on days 1-28 as tolerability permits Cycle 9 and beyond: 10 mg orally daily on days 1-28
16306214|NCT00602836|Drug|Pentostatin|2 mg/m^2 by IV on day 1 of cycles 1-6 (every 21 days)
16306215|NCT00602797|Drug|Paclitaxel|Given IV
16306216|NCT00602797|Other|Quality-of-Life Assessment|Ancillary studies
16306217|NCT00602797|Other|Questionnaire Administration|Ancillary studies
16306218|NCT00602797|Drug|Vinorelbine Tartrate|Given IV
16306219|NCT00602784|Biological|IC41|
16306220|NCT00602771|Drug|tipifarnib|Given orally
16306221|NCT00602771|Drug|etoposide|Given orally
16306222|NCT00602758|Behavioral|Motivational interviewing with cognitive behavioral therapy|Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.
16306223|NCT00602758|Behavioral|Modified directly observed therapy|From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.
16306224|NCT00602745|Drug|S-1|oral administration
16306225|NCT00602745|Drug|5-Fluorouracil|intravenous bolus
16306226|NCT00602732|Behavioral|The Reach Out for a Safe Environment (ROSE) program|Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help. The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery. Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
16306227|NCT00602732|Behavioral|Enhanced care as usual (ECU)|Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic. Participants will also receive educational material and a list of treatment resources for depression.
16306228|NCT00602719|Drug|Zolpidem|
16306229|NCT00602706|Biological|sargramostim|
16306230|NCT00602706|Drug|melphalan|
16306231|NCT00602706|Procedure|autologous hematopoietic stem cell transplantation|
16306232|NCT00602706|Procedure|peripheral blood stem cell transplantation|
16306233|NCT00602706|Radiation|samarium Sm 153 lexidronam pentasodium|
16306234|NCT00602693|Biological|umbilical cord blood transplantation|Infusion of umbilical cord blood
16306235|NCT00602693|Drug|Allopurinol|Administration begins Day -7 through Day 0, tablet or powder prescribed on an individual basis.
16306236|NCT00602693|Drug|fludarabine phosphate|40 mg/m^2 intravenously over 1 hour on Days -6, -5, -4, -3, -2
16306237|NCT00602693|Drug|Cyclophosphamide|50 mg/kg intravenous over 2 hours on Day -6
16306238|NCT00602693|Radiation|Total body irradiation|200 cGy on Day -1
16306239|NCT00602693|Biological|Treg infusion|Infusion of T regulatory cells on Day +1 (also Day +15 for Dose level 5 only). Dose escalation ranges include 1, 3, 10, 30, 100, 300 1000, and 300 x 10^5 Treg/kg.
16306240|NCT00602693|Drug|Sirolimus|Beginning on day -3 and continuing until day +100, patients receive sirolimus intravenously (IV) with 8-12 mg oral loading dose followed by a single dose of 4mg/day with a target serum concentration of 3-12 mg/mL with a taper until day +180.
16306241|NCT00602680|Drug|SSR180711C|duration of treatment: 4 weeks
16306242|NCT00602680|Drug|donepezil|duration of treatment: 4 weeks
16306243|NCT00602680|Drug|placebo|duration of treatment: 4 weeks
16306244|NCT00602667|Drug|Induction Chemotherapy|All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.
16306300|NCT00602394|Drug|Lithium|
16306301|NCT00602381|Drug|Lithium|
16306302|NCT00602368|Other|histological technique|
16306245|NCT00602667|Drug|Low-Risk Therapy|Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
16306246|NCT00602667|Drug|High-Risk Therapy|High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
16306247|NCT00602667|Drug|Intermediate-Risk Therapy|"Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).
~Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan."
16306248|NCT00602641|Other|Laboratory Biomarker Analysis|Optional correlative studies
16306249|NCT00602641|Drug|Lenalidomide|Given PO
16306250|NCT00602641|Drug|Melphalan|Given PO
16306251|NCT00602641|Drug|Prednisone|Given PO
16306252|NCT00602641|Other|Quality-of-Life Assessment|Ancillary studies
16306253|NCT00602641|Drug|Thalidomide|Given PO
16306254|NCT00602628|Other|questionnaire administration|
16306255|NCT00602628|Procedure|adjuvant therapy|
16306256|NCT00602628|Procedure|biopsy|
16306257|NCT00602628|Procedure|computed tomography|
16306258|NCT00602628|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16306259|NCT00602628|Procedure|magnetic resonance imaging|
16306260|NCT00602628|Procedure|therapeutic conventional surgery|
16306261|NCT00602628|Procedure|ultrasound imaging|
16306262|NCT00602628|Radiation|radiation therapy|
16306263|NCT00602615|Drug|Torsemide|
16306264|NCT00602602|Biological|bevacizumab|
16306265|NCT00602602|Drug|fluorouracil|
16306266|NCT00602602|Drug|gemcitabine hydrochloride|
16306267|NCT00602602|Drug|oxaliplatin|
16306268|NCT00602602|Other|immunohistochemistry staining method|
16306269|NCT00602602|Other|laboratory biomarker analysis|
16306270|NCT00602602|Procedure|conventional surgery|
16306271|NCT00602602|Procedure|endoscopic biopsy|
16306272|NCT00602602|Procedure|laparoscopy|
16306273|NCT00602602|Radiation|radiation therapy|
16306274|NCT00602589|Drug|Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations|
16306275|NCT00602576|Drug|sorafenib tosylate|Given orally
16306276|NCT00602576|Drug|temozolomide|Given orally
16306277|NCT00602563|Behavioral|AMP|The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word.
16306278|NCT00602563|Behavioral|Applied Relaxation (AR)|Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007)
16306279|NCT00602563|Behavioral|Clinical Monitoring (CM)|participants assigned to the clinical monitoring (CM) condition will receive the same information about the nature of GAD provided to participants in the active conditions
16306280|NCT00602563|Behavioral|Combining the AMP and AR|The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word. Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways
16306281|NCT00602550|Drug|Zidovudine|
16306282|NCT00602537|Drug|Venlafaxine|75 to 375 mg
16306283|NCT00602537|Drug|Lithium Carbonate|300 to 2400 mg
16306284|NCT00602524|Drug|Pilocarpine|
16306285|NCT00602511|Drug|Bortezomib|"Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles
~Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity"
16306286|NCT00602511|Drug|Thalidomide|"Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day
~Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity"
16306287|NCT00602498|Drug|Clarithromycin|
16306288|NCT00602485|Other|Action Control Education|30 minute educational intervnetion
16306289|NCT00602472|Drug|linagliptin|active
16306290|NCT00602472|Drug|placebo|placebo to linagliptin 5 mg
16306291|NCT00602459|Drug|Cyclophosphamide|Given IV
16306292|NCT00602459|Drug|Fludarabine Phosphate|Given IV or PO
16306293|NCT00602459|Other|Laboratory Biomarker Analysis|Correlative studies
16306294|NCT00602459|Drug|Lenalidomide|Given PO
16306295|NCT00602459|Biological|Rituximab|Given IV
16306296|NCT00602446|Drug|deferasirox|20 mg/kg once daily orally for 6 months
16306297|NCT00602420|Drug|naproxen|Oral naproxen twice daily for 5-8 days.
16306298|NCT00602420|Other|placebo|Oral placebo twice daily for 5-8 days.
16306304|NCT00602368|Procedure|colposcopic biopsy|
16306305|NCT00602368|Procedure|colposcopy|
16306306|NCT00602368|Procedure|light-scattering spectroscopy|
16306307|NCT00602368|Procedure|loop electrosurgical excision procedure|
16306308|NCT00602355|Drug|Sertraline|"Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care."
16306309|NCT00602355|Drug|Placebo|"Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline."
16306310|NCT00602355|Behavioral|Interpersonal psychotherapy (IPT)|IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
16306311|NCT00602355|Behavioral|Clinical management|Clinical management includes treatment as usual for those receiving medication for depression.
16306312|NCT00602355|Behavioral|Mothercrafting|Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
16306313|NCT00602342|Drug|Terbinafine|
16306314|NCT00602329|Biological|bevacizumab|Given IV
16306315|NCT00602329|Drug|fluorouracil|Given IV
16306316|NCT00602329|Drug|leucovorin calcium|Given IV
16306317|NCT00602329|Drug|oxaliplatin|Given IV
16306318|NCT00602316|Drug|gadolinium-chelate|
16306319|NCT00602316|Procedure|conventional surgery|
16306320|NCT00602316|Procedure|magnetic resonance imaging|
16306321|NCT00602316|Procedure|magnetic resonance spectroscopic imaging|
16306322|NCT00602303|Drug|Torsemide|
16306323|NCT00602290|Drug|Citalopram|Citalopram dosage will be 20 to 60 mg a day prior to FDA warning limiting it to 20-40 mg in 2011. Participants will begin taking one 20-mg capsule once per day for 4 weeks, and this dosage may be increased or decreased depending on the participant's response to the medication or side-effect profile. Participants will continue on their assigned dosage of citalopram that will be titrated up after week 4 if clinical global impressions (CGI) scores were > 2 until treatment completion.
16306324|NCT00602290|Drug|Methylphenidate (MPH)|MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule (2.5 mg) twice per day, which will be increased to a maximum up to 8 x 2.5 mg capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
16306325|NCT00602290|Drug|Placebo|Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day matching methylphenidate, and 1-3 capsules matching citalopram. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
16306326|NCT00602277|Other|Laboratory Biomarker Analysis|Correlative studies
16306327|NCT00602277|Biological|Wild-type Reovirus|
16306328|NCT00602251|Drug|Terbinafine|
16306329|NCT00602225|Drug|clofarabine|Given IV
16306330|NCT00602225|Drug|cytarabine|Given IV
16306331|NCT00602225|Biological|filgrastim|Given subcutaneously
16306332|NCT00602212|Behavioral|relaxation with virtual reality (VR)|VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
16306333|NCT00602212|Behavioral|relaxation and biofeedback virtual reality|The patients experienced the same protocol described above, but with the biofeedback support. Specifically, in the sessions with the therapist, HR variations were used to modify specific features of the virtual environment:
16306334|NCT00602199|Drug|ABT-510|
16306335|NCT00602199|Other|immunoenzyme technique|
16306336|NCT00602199|Other|immunohistochemistry staining method|
16306337|NCT00602199|Other|laboratory biomarker analysis|
16306338|NCT00602199|Other|pharmacological study|
16306339|NCT00602199|Procedure|biopsy|
16306340|NCT00602186|Drug|tamsolusin|0.4 mg /day
16306341|NCT00602186|Drug|prazosin|1 mg/day
16306342|NCT00602173|Drug|Cilostazol|
16306343|NCT00602160|Drug|FAHF-2 (TM)|"We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.
~Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy."
16306344|NCT00602147|Other|laboratory biomarker analysis|Blood or cheek cells wil be collected.
16306345|NCT00602134|Drug|6-Mercaptopurine|
16306346|NCT00602108|Procedure|adjuvant therapy|
16306347|NCT00602108|Procedure|conventional surgery|
16306348|NCT00602108|Radiation|hypofractionated radiation therapy|
16306349|NCT00602108|Radiation|intraoperative radiation therapy|
16306350|NCT00602095|Drug|misoprostol|0.025mg tablet vaginally every 4 hour until progress
16306351|NCT00602095|Drug|dinoprostone|2mg vaginal gel every 6 hours until progress
16306352|NCT00602095|Device|Bard Catheter (balloon catheter)|Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
16306353|NCT00602082|Drug|capecitabine|
16306354|NCT00602082|Drug|cisplatin|
16306355|NCT00602082|Drug|streptozocin|
16306356|NCT00602082|Genetic|DNA analysis|
16306357|NCT00602082|Genetic|RNA analysis|
16306358|NCT00602082|Genetic|protein analysis|
16306359|NCT00602082|Genetic|proteomic profiling|
16306360|NCT00602082|Other|laboratory biomarker analysis|
16306361|NCT00602069|Behavioral|Helping to Overcome PTSD through Empowerment (HOPE)|HOPE includes a maximum of 16 sessions of cognitive behavioral therapy. The sessions will emphasize stabilization and empowerment, both of which are identified as important goals by the theoretical and empirical literature on abused women and PTSD.
16306362|NCT00602069|Behavioral|Treatment as usual|Treatment as usual includes standard shelter services for abused women.
16306363|NCT00602056|Other|Redesigned immunization card|A low cost nad simplified redesigned immunization card
16306364|NCT00602056|Other|Center based education to mothers/caregivers|A 2-3 minute center based education to mothers/caregivers
16306365|NCT00602056|Other|Redesigned immunization card with center based education to mother/caregivers|Redesigned immunization card with center based education to mother/caregivers
16306366|NCT00602043|Radiation|F-18 16 alpha-fluoroestradiol|Undergo [^18F] FES PET
16306367|NCT00602043|Radiation|fludeoxyglucose F 18|Undergo standard clinical FDG PET/CT
16306368|NCT00602043|Procedure|positron emission tomography|Undergo [^18F] FES PET
16306369|NCT00602043|Procedure|positron emission tomography|Undergo standard clinical FDG PET/CT
16306370|NCT00602043|Procedure|computed tomography|Undergo standard clinical FDG PET/CT
16306371|NCT00602043|Other|laboratory biomarker analysis|Correlative studies
16306372|NCT00602030|Drug|entinostat|"Dose cohort 1: SNDX-275 5mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)
~Dose cohort 2: SNDX-275 10mg tablets on days 1 and 15 of 28-day cycle (max. 6 cycles)"
16306373|NCT00602030|Drug|SNDX-275|entinostat 5mg or 10mg (determined by Lead in study findings) on days 1 and 15 of a 28-day cycle until progression or unacceptable toxicity develops; maximum of 6 cycles
16306374|NCT00602030|Drug|erlotinib|erlotinib 150mg PO QD
16306375|NCT00602017|Drug|Amlodipine|
16306376|NCT00602004|Drug|losartan|losartan 50 mg a day
16306377|NCT00601991|Biological|VEGF Trap|Drug under investigation
16306378|NCT00601991|Procedure|Bone marrow biopsy|To determine response to treatment
16306379|NCT00601991|Procedure|bone marrow aspiration|To determine response to treatment
16306380|NCT00601991|Procedure|Venipuncture|For test of free VEGF Trap compared to bound VEGF Trap and for routine clinical testing during treatment
16306381|NCT00601978|Drug|carbidopa/levodopa|
16306382|NCT00601978|Drug|Carbidopa/Levodopa/Entacapone|
16306383|NCT00601965|Drug|Escitalopram|20 mg daily oral escitalopram
16306384|NCT00601965|Drug|Placebo|Placebo pill of daily oral escitalopram
16306385|NCT00601965|Behavioral|Cognitive behavioral therapy (CBT)|16 weekly 1-hour sessions
16306386|NCT00601952|Behavioral|Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
16306387|NCT00601952|Behavioral|Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
16306388|NCT00601939|Behavioral|Psychoeducational intervention (PEI)|PEI consists of 10 culturally competent group empowerment psychoeducational sessions. The sessions are directed by a treatment manual and are co-led by two therapists. The sessions are guided by the theory of triadic influence (TTI) model, which incorporates cultural-environmental influences, social-situational influences, and intrapersonal influences into treatment.
16306389|NCT00601939|Behavioral|Enhanced treatment as usual (ETAU)|ETAU contains an adherence protocol plus access to weekly support group and a resource room.
16306390|NCT00601926|Biological|bevacizumab|15 mg/kg over 90 minutes every 3 weeks
16306391|NCT00601913|Drug|erlotinib hydrochloride|
16306392|NCT00601913|Genetic|protein analysis|
16306393|NCT00601913|Genetic|western blotting|
16306394|NCT00601913|Other|immunohistochemistry staining method|
16306395|NCT00601913|Other|laboratory biomarker analysis|
16306396|NCT00601913|Other|liquid chromatography|
16306397|NCT00601913|Other|mass spectrometry|
16306398|NCT00601913|Procedure|neoadjuvant therapy|
16306399|NCT00601913|Procedure|therapeutic conventional surgery|
16306400|NCT00601900|Biological|Bevacizumab|Given IV
16306401|NCT00601900|Other|Laboratory Biomarker Analysis|Correlative studies
16306402|NCT00601900|Drug|Letrozole|Given PO
16306403|NCT00601900|Other|Questionnaire Administration|Ancillary studies
16306404|NCT00601900|Drug|Tamoxifen Citrate|Given PO
16306405|NCT00601887|Drug|Meloxicam|
16306406|NCT00601874|Drug|Pilocarpine|
16306407|NCT00601861|Drug|recombinant interleukin-21|Fixed and equal dose for s.c. injection, 3 times weekly
16306408|NCT00601848|Drug|chemotherapy|
16306409|NCT00601848|Drug|porfimer sodium|
16306410|NCT00601848|Other|immunohistochemistry staining method|
16306411|NCT00601848|Other|laboratory biomarker analysis|
16306412|NCT00601848|Procedure|spectroscopy|
16306413|NCT00601848|Procedure|therapeutic conventional surgery|
16306414|NCT00601835|Biological|Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine|0.5 mL, Intramuscular, single dose
16306415|NCT00601835|Biological|Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine|0.5 mL, Intramuscular, Single dose
16306416|NCT00601822|Behavioral|Cognitive remediation therapy (CRT)|CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.
16306417|NCT00601822|Behavioral|Cognitive behavioral therapy (CBT)|CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.
16306418|NCT00601809|Other|traditional conservative treatment (TT)|In the control group (TT: Traditional Treatment), the patients have been treated as in our daily surgical practice of traditional conservative treatment for ASIO, consisting in nil per os diet, nasogastric tube (NGT) decompression and intravenous fluid resuscitation therapy with electrolytes imbalances correction.
16306700|NCT00599872|Biological|Standardized Ragweed Allergenic Extract|Standardized Ragweed Allergenic Extract, sublingual oral
16306419|NCT00601809|Drug|Gastrografin®: G|The study group (GG: Gastrografin Group) received, beyond the traditional conservative treatment for ASIO above mentioned, a G meal with a follow-through study immediately.
16306420|NCT00601796|Biological|Vaccine Treatment|We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
16306421|NCT00601796|Drug|Cyclophosphamide|Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.
16306422|NCT00601796|Drug|All-trans retinoic acid (ATRA)|All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
16306423|NCT00601770|Biological|IC41|injection
16306424|NCT00601757|Behavioral|The Postpartum Prevention Program (PPP)|PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period.
16306425|NCT00601757|Behavioral|Enhanced care as usual (ECU)|ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice.
16306426|NCT00601744|Behavioral|Audio-Taped Interview|"Meeting with a research staff member either in person or by phone, lasting 2 to 2 1/2 hours
~Arm 1: Questions about emotional well-being, appearance, coping ability with the cancer, and the types of social relations and support available (such as relationships with friends and family)
~Arm 2: Questions regarding if and how social relations may have been affected by his/her cancer experiences after the orbital exenteration."
16306427|NCT00601744|Behavioral|Questionnaire|5-10 minute questionnaire to be completed after the interview.
16306428|NCT00601731|Biological|MenACWY-CRM197|Blood test, 40-months and 60-months children
16306429|NCT00601731|Biological|Blood test|Blood test, 40-months and 60-months children
16306430|NCT00601718|Drug|vorinostat|Given PO
16306431|NCT00601718|Biological|rituximab|Given IV
16306432|NCT00601718|Drug|ifosfamide|Given IV
16306433|NCT00601718|Drug|carboplatin|Given IV
16306434|NCT00601718|Drug|etoposide|Given IV
16306435|NCT00601718|Other|pharmacological study|Correlative studies
16306436|NCT00601718|Other|laboratory biomarker analysis|Correlative studies
16306437|NCT00601718|Genetic|gene expression analysis|Correlative studies
16306438|NCT00601705|Drug|cisplatin|20 mg/m2/day IV continuous infusion over 24 hours for 96 total hours.
16306439|NCT00601705|Drug|epirubicin hydrochloride|50 mg/m2 IV bolus
16306440|NCT00601705|Drug|fluorouracil|200 mg/m2/day will be given as a continuous intravenous infusion for all 9 weeks, beginning on day 1.
16306441|NCT00601705|Drug|oxaliplatin|130 mg/m2 IV infusion over 2 hours
16306442|NCT00601705|Procedure|adjuvant therapy|Between 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given to the esophago-gastric bed and draining lymphatic regions to a total dose of 50-55 Gy (60 Gy in the event of an R1 or R2 resection). Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation
16306443|NCT00601705|Procedure|neoadjuvant therapy|"Three weeks after discontinuing the fluorouracil (12 weeks after study entry) patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for approximately one week later (13 weeks after study entry).
~Surgery will consist of a transthoracic esophagogastrectomy or a total gastrectomy with Roux-en-Y esophagojejunostomy depending on the location and extent of the tumor at surgery. An appropriate lymphadenectomy will be performed. Immediate reconstruction is anticipated if possible."
16306444|NCT00601692|Drug|cisplatin|Given IV
16306445|NCT00601692|Drug|docetaxel|Given IV
16306446|NCT00601692|Drug|irinotecan hydrochloride|Given IV
16306447|NCT00601692|Radiation|radiation therapy|Given 5 days a week for 3 weeks
16306448|NCT00601679|Other|NT-proBNP guided care|knowledge of NT-proBNP results
16306449|NCT00601666|Drug|Zolpidem|
16306450|NCT00601653|Behavioral|Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)|CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.
16306451|NCT00601653|Behavioral|Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)|CBT+LED includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling that centers upon eating higher volumes of low-calorie foods.
16306452|NCT00601640|Drug|Diclofenac Na gel|Given topically twice daily on days 1-90
16306453|NCT00601640|Drug|Eflornithine HCL ointment|Given topically twice daily on days 1-90
16306454|NCT00601627|Biological|panitumumab|
16306455|NCT00601627|Drug|capecitabine|
16306456|NCT00601627|Drug|fluorouracil|
16306457|NCT00601627|Drug|gemcitabine hydrochloride|
16306458|NCT00601627|Radiation|radiation therapy|
16306459|NCT00601614|Drug|temozolomide|
16306460|NCT00601614|Drug|vandetanib|
16306461|NCT00601614|Other|immunoenzyme technique|
16306462|NCT00601614|Other|laboratory biomarker analysis|
16306463|NCT00601588|Drug|Sertraline|
16306464|NCT00601575|Drug|Lithium|
16306465|NCT00601562|Drug|Zidovudine|
16306466|NCT00601549|Procedure|Laparoscopic surgery|Laparoscopic surgery
16306467|NCT00601549|Procedure|Traditional open surgery|Open surgery
16306468|NCT00601536|Drug|Lithium|
16306469|NCT00601523|Drug|Placebo|Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
16306470|NCT00601523|Drug|Pramipexole|ER 0.375-4,5 mg
16306471|NCT00601510|Drug|capecitabine|
16306472|NCT00601510|Drug|cisplatin|
16306473|NCT00601510|Drug|imatinib mesylate|
16306474|NCT00601497|Device|InterX 5000|20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
16306475|NCT00601484|Drug|PF-04383119|PF-04383119 200 mcg/kg IV, single dose
16306476|NCT00601484|Drug|Placebo|placebo IV, single dose
16306477|NCT00601471|Other|proximal tibiofibular manipulation|proximal tibiofibular manipulation
16306478|NCT00601471|Other|distal tibiofibular manipulation|distal tibiofibular manipulation
16306479|NCT00601471|Other|no intervention|no intervention / control
16306480|NCT00601458|Drug|pregabalin|Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
16306481|NCT00601458|Drug|naproxen sodium|Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.
16306482|NCT00601458|Drug|Comparator: Placebo|Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
16306483|NCT00601445|Behavioral|Amount of sleep and wake|4 groups with different patterns of sleep and wake
16306484|NCT00601432|Drug|levofloxacin oral solution|
16306485|NCT00601419|Drug|Somatropin|"Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg.
~Dosage, Frequency: According to Japanese LPD, The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day.
~Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration."
16306486|NCT00601406|Genetic|gene expression analysis|
16306487|NCT00601406|Genetic|gene rearrangement analysis|
16306488|NCT00601406|Genetic|polymorphism analysis|
16306489|NCT00601406|Other|laboratory biomarker analysis|
16306490|NCT00601406|Radiation|radiation therapy|
16306491|NCT00601393|Behavioral|Cognitive behavioral therapy (CBT)|CBT treatment is delivered via the Internet. Adaptations to the CBT program will include the addition of content of particular relevance to mothers of young children and the incorporation of instructional design principles to promote self-learning. The treatment program will take advantage of the unique properties of the Internet, including multimedia presentations and interactive components with professional and moderated peer social support.
16306492|NCT00601393|Other|Treatment as usual (TAU)|Participants receiving TAU will be offered the CBT treatment after a wait-list period. During the wait-list period, participants will be offered facilitated referrals to treatment provided in the community.
16306493|NCT00601367|Drug|flibanserin flexible dose|"Initial dosage:
~Patients were to take one 50 mg flibanserin tablet in the evening.
~Subsequent dosage titrations:
~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
~Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.
~Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
16306494|NCT00601354|Behavioral|Emotion regulation group therapy|Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
16306495|NCT00601354|Drug|Orlistat/alli program|The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
16306496|NCT00601341|Other|lumbosacral joint manipulation|lumbosacral joint manipulation
16306497|NCT00601341|Other|lumbar passive range of motion|lumbar passive range of motion
16306498|NCT00601341|Other|No active intervention|Lie on exam table for 3 minutes
16306499|NCT00601328|Drug|Calcitriol|
16306500|NCT00601315|Drug|Clarithromycin|
16306501|NCT00601302|Drug|Amlodipine|
16306502|NCT00601289|Drug|temozolomide|
16306503|NCT00601289|Genetic|DNA methylation analysis|
16306504|NCT00601289|Genetic|microarray analysis|
16306505|NCT00601289|Genetic|protein expression analysis|
16306506|NCT00601289|Genetic|proteomic profiling|
16306507|NCT00601289|Other|laboratory biomarker analysis|
16306508|NCT00601276|Drug|leuprorelin|Subcutaneous injection, 3.75 mg every 4 weeks
16306509|NCT00601276|Drug|Cyproterone acetate|2.0 mg/kg/day, tablet, per os
16306510|NCT00601263|Drug|Anti-Asthma Herbal Medical Intervention (ASHMI)|We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.
16306511|NCT00601250|Drug|linagliptin|Patients receive linagliptin 5 mg tablets once daily
16306512|NCT00601250|Drug|linagliptin|Patients receive linagliptin 5 mg tablets once daily
16306513|NCT00601237|Behavioral|HIV-related text messaging|Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
16306514|NCT00601237|Behavioral|Nutrition-related text messaging|Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
16306515|NCT00601224|Behavioral|Social cognition and interaction training (SCIT)|SCIT is a group-based treatment that has the goal of improving social cognition and social functioning for individuals with psychotic disorders. SCIT is composed of three phases: emotion training, figuring out situations, and integration. SCIT will be delivered by two therapists in 20 weekly sessions over 5 months.
16306701|NCT00599872|Biological|Placebo|Placebo, sublingual oral
16306516|NCT00601224|Behavioral|Treatment as usual (TAU)|TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
16306517|NCT00601211|Drug|Pilocarpine|
16306518|NCT00601198|Drug|Amifostine|Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression
16306519|NCT00601185|Procedure|confocal microscopy in vivo|A dermatologist will perform a shave biopsy according to standard clinical procedures. This study will be carried out after the shave biopsy. The deep surface and the peripheral margins will be imaged on each patient.
16306520|NCT00601172|Drug|Casopitant|Experimental NK-1 receptor antagonist
16306521|NCT00601172|Drug|Dexamethasone|Standard antiemetics
16306522|NCT00601172|Drug|Placebo|Placebo to match IV casopitant
16306523|NCT00601172|Drug|Ondansetron|Standard antiemetics
16306524|NCT00601159|Drug|gemcitabine and cisplatin|Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks
16306525|NCT00601146|Procedure|chest computed tomography scan|Once a year for three years
16306526|NCT00601133|Other|Walking Test|"Timed Test 1: From sitting position walk 10 feet quickly, return to sitting position Timed Test 2: Walk 25 feet, turn around, and walk back
~Tests conducted twice, once on departure from rehabilitation center, and again at a return visit 1 month later"
16306527|NCT00601133|Other|Balance Test|Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.
16306528|NCT00601133|Behavioral|Questionnaire|To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.
16306529|NCT00601133|Behavioral|Diary|Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry
16306530|NCT00601120|Procedure|Radiofrequency Ablation|Needles are inserted into the tumor(s) under guidance by a CT scan or ultrasound. The electrodes in the needles will be heated up to 202 degrees Fahrenheit and will remain heated for up to 12 minutes.
16306531|NCT00601107|Drug|Doxercalciferol|
16306532|NCT00601107|Drug|Placebo|
16306533|NCT00601094|Biological|autologous dendritic cell-adenovirus CCL21 vaccine|Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
16306534|NCT00601068|Other|Observational|Group of patients with osteochemonecrosis related to oral bisphosphonate use
16306535|NCT00601055|Behavioral|Problem Solving-Rx Adherence (PSA)|In PSA, a therapist teaches the participant to identify problems related to depression, functioning, and treatment adherence; to generate multiple solutions; and to choose and implement one or more of those solutions.
16306536|NCT00601055|Behavioral|PID-C|In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
16306537|NCT00601042|Other|Swedish snus (smokeless tobacco)|Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
16306538|NCT00601042|Other|Onico|Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum.
16306539|NCT00601016|Drug|Imiquimod 5% cream|Imiquimod 5% cream applied topical on hemangioma once a day , 3 to 7 times a week for a maximum of 4 months.
16306540|NCT00601003|Drug|Nifurtimox|30mg/kg/day PO divided into TID dosing q day
16306541|NCT00601003|Drug|Cyclophosphamide|250 mg/m2/dose in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.
16306542|NCT00601003|Drug|Topotecan|0.75mg/m2/dose, in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.
16306543|NCT00600990|Drug|GW597599|
16306544|NCT00600977|Drug|Doxorubicine|9mg/m² J1 J4 2 COURSES
16306545|NCT00600977|Drug|Doxorubicine pegylated|40 MG/M² J1 2 courses
16306546|NCT00600964|Drug|GX15-070MS|A 60-minute or 3-hour IV infusion every 2-3 weeks.
16306547|NCT00600964|Drug|GX15-070MS|GX15-070MS at various doses and schedules
16306548|NCT00600938|Drug|Core Study: Deferasirox|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
16306549|NCT00600938|Drug|Core Study: Deferoxamine|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
16306550|NCT00600938|Drug|Extension: deferoxamine to deferasirox|40 mg/kg deferasirox once daily administered 30 minutes before taking food.
16306551|NCT00600938|Drug|Extension: deferasirox to deferoxamine|DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
16306552|NCT00600938|Drug|Deferasirox|
16306553|NCT00600938|Drug|Deferoxamine|
16306554|NCT00600925|Drug|gentamicin-collagen sponge dipped in saline|2 gentamicin-collagen sponges inserted before closure of the laparotomy
16306555|NCT00600912|Drug|SMOFlipid®|continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.
16306556|NCT00600912|Drug|2-ClinOleic 20%®|continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.
16306557|NCT00600899|Procedure|elastomeric pump with reservoir of 500 ml, infusion rate of 8 ml/h|Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 500 ml reservoir and infusion rate of 8 ml/h)
16306558|NCT00600899|Procedure|elastomeric pump with reservoir of 275 ml, infusion rate of 5 ml/h|Continuous perisciatic infusion of ropivacaine 2mg/ml (Baxter infusor with 275 ml reservoir and infusion rate of 5ml/h)
16306559|NCT00600886|Drug|Pasireotide|Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.
16306560|NCT00600886|Drug|Octreotide|Octreotide LAR - i.m. depot injection given once every 28 days.
16306561|NCT00600873|Drug|R(+) pramipexole dihydrochloride monohydrate|100 mg tid orally daily
16306562|NCT00600860|Other|No interventions|Only registration of clinical practice
16306563|NCT00600847|Drug|desloratadine|single dose for 7 days, oral, 20mg
16306564|NCT00600847|Drug|desloratadine|single dose for 7 days, oral, 5 mg
16306565|NCT00600847|Drug|placebo|single dose for 7 days, oral
16306566|NCT00600821|Drug|Bevacizumab|Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
16306567|NCT00600821|Drug|Carboplatin|Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
16306568|NCT00600821|Drug|Paclitaxel|Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
16306569|NCT00600821|Drug|AG-013736 (axitinib)|AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
16306570|NCT00600821|Drug|Carboplatin|Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
16306571|NCT00600821|Drug|Paclitaxel|Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
16306572|NCT00600808|Drug|BPLG-003|
16306573|NCT00600795|Other|CSF collection|CSF collection at time of VPS insertion
16306574|NCT00600782|Biological|GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)|Intramuscular injection, 2 doses at 0, 1 month
16306575|NCT00600769|Drug|Clarithromycin|Dosage dependent on clinical factors such as age, weight and patient-specific health status
16306576|NCT00600756|Drug|Quetiapine XR|Oral, once daily, tablets of 400 mg to 800 mg
16306577|NCT00600756|Drug|Risperidone|Oral, once daily, tablets of 2 mg to 6 mg
16306578|NCT00600743|Drug|GSKI181771X (CCK-1R agonist)|Drug one trial vs placebo
16306579|NCT00600743|Behavioral|Instructions to binge eat|Subjects will be instructed to binge eat and will also be given either drug or placebo
16306580|NCT00600743|Behavioral|Instructions to eat normally|Subjects will be instructed to eat normally and will also be given either drug or placebo
16306581|NCT00600743|Drug|Placebo|Drug one trial vs placebo
16306582|NCT00600730|Procedure|Hyperinsulinemic euglycemic clamp with fMRi|Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
16306583|NCT00600730|Procedure|Hyperinsulinemic hypoglycemic clamp study with fMRi|Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning
16306584|NCT00600704|Procedure|Fluid Restriction Policy|Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
16306585|NCT00600704|Procedure|Free fluid infusion|Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
16306586|NCT00600691|Drug|Finasteride|one tablet (5mg) of finasteride
16306587|NCT00600678|Dietary Supplement|ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)|Single, oral administration of nutritional supplement under fasting condition within 2 minutes.
16306588|NCT00600665|Behavioral|PAINReportIt|A pain assessment data collection tool
16306589|NCT00600665|Behavioral|PAINUCope|A multimedia patient education program tailored to the participant's SCD pain management misconceptions
16306590|NCT00600665|Behavioral|PAINConsultN|A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
16306591|NCT00600639|Device|Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option|A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask
16306592|NCT00600639|Drug|standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed|Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
16306593|NCT00600639|Drug|standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed|oxygen plus medical therapy for ARF
16306594|NCT00600626|Drug|biphasic insulin aspart|
16306595|NCT00600626|Drug|insulin NPH|
16306596|NCT00600626|Drug|insulin aspart|
16306597|NCT00600613|Radiation|cone beam imaging|All study patients will undergo simulation, treatment planning and verification as currently practiced. The contrast injection and cone beam imaging will be added to the standard procedure just prior to treatment delivery on the first and last days of treatment only.
16306598|NCT00600600|Drug|Tigecycline|Tigecycline dosage based on age and clinical status of patient.
16306599|NCT00600587|Drug|neoadjuvant erlotinib therapy|150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
16306600|NCT00600587|Drug|neoadjuvant gemcitabine/carboplatin therapy|3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.
16306601|NCT00600574|Other|physical therapy|weekly pool physiotherapy with muscle stretching
16306602|NCT00600574|Other|physical therapy|weekly pool physiotherapy with Ai Chi movements during a 6 months period
16306603|NCT00600561|Behavioral|MBSR|Mindfulness-Based Stress Reduction Intervention
16306604|NCT00600548|Drug|Miltefosine.|Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
16306605|NCT00600548|Drug|Meglumine antimoniate.|Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
16306606|NCT00600548|Drug|Miltefosine.|Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
16306607|NCT00600548|Drug|Meglumine antimoniate.|Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
16306608|NCT00600535|Drug|Stage 1 Group 1: abiraterone acetate|1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
16306609|NCT00600535|Drug|Stage 1 Group 2: abiraterone acetate|1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
16306610|NCT00600535|Drug|Stage 2: abiraterone acetate|1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
16306611|NCT00600535|Drug|Stage 3: abiraterone acetate|1000 mg tablets/day orally for 12 cycles (28 days/cycle).
16306612|NCT00600535|Drug|Stage 3: glucocorticoid|prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
16306613|NCT00600535|Drug|Stage 4: abiraterone acetate|1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
16306614|NCT00600535|Drug|Stage 4: glucocorticoid|prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
16306615|NCT00600522|Procedure|Ultrasound-guided hepatectomy|"After laparotomy and staging by intraoperative ultrasound (IOUS), anterior surface of the hepatocaval confluence is exposed. Than, compression by means of the surgeon's finger-tip is applied at the MHV caval confluence verifying at color-Doppler IOUS the disappearance of the blood flow in the MHV or its inversion. Then, MHV clamping itself is carried out, and parenchymal sparing resection would be selected if at least one of these 3 findings is confirmed:
~Reversal color-Doppler IOUS flow direction in the peripheral portion of the MHV, which suggests the drainage through collateral circulation in the RHV/LHV depending on the side of the MHV branch with reversal flow.
~Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV.
~Hepatopetal flow in P5-8 and/or P4inf portal branches. If none of these finding is confirmed and in particular hepatofugal flow direction in the P5-8 and/or P4 inf is detected the hepatectomy has to be extended."
16306616|NCT00600509|Drug|Levetiracetam|
16306617|NCT00600496|Drug|AZD6244|twice daily oral dose
16306618|NCT00600496|Drug|Dacarbazine|intravenous infusion
16306619|NCT00600496|Drug|Erlotinib|daily oral dose
16306620|NCT00600496|Drug|Docetaxel|intravenous infusion
16306621|NCT00600496|Drug|Temsirolimus|intravenous infusion
16306622|NCT00600483|Drug|gentamicin-collagen sponge dipped in saline|100-cm2 sponge
16306623|NCT00600470|Behavioral|Doctor-office collaborative care (DOCC) management|DOCC is an evidence-based psychosocial treatment approach that incorporates (1) adaptation of an evidence-based collaborative care approach using the chronic care model and participatory management theory to enhance training, implementation, and sustainability; (2) revised protocol content that includes medication management for ADHD, brief anxiety management, and attention to parental/partner dysfunction; (3) technological developments to facilitate screening/assessment, monitoring, and communication; and (4) an improved methodology that includes new samples, measures, and settings.
16306624|NCT00600470|Behavioral|Treatment as usual (TAU)|TAU involves routine care: psychoeducation and referral to outside providers.
16306625|NCT00600457|Device|Polyurethane Film|The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day
16306626|NCT00600444|Procedure|Venae sectio|surgical preparation of the cephalic vene to insert a totally implantable access port.
16306627|NCT00600444|Procedure|Punction of V. subclavia|radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
16306628|NCT00600405|Drug|tamsulosin|Tamsulosin 0.4 mg orally daily for ten days.
16306629|NCT00600405|Drug|Standard therapy with ibuprofen and oxycodone.|Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.
16306630|NCT00600379|Device|Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).|Training 2/w for 9 weeks (total 18 sessions).
16306631|NCT00600366|Drug|biphasic insulin aspart|
16306632|NCT00600353|Drug|Palonosetron|Palonosetron 0.25 mg IV over 30 seconds
16306633|NCT00600353|Drug|Aprepitant|Aprepitant 125 mg PO and Aprepitant 80 mg PO
16306634|NCT00600353|Drug|Dexamethasone|Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push
16306635|NCT00600340|Biological|Bevacizumab and Paclitaxel|A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
16306636|NCT00600340|Biological|Bevacizumab and Capecitabine|B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
16306637|NCT00600327|Device|EndoTex™ NexStent™|EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
16306638|NCT00600327|Device|Filter Wire EZ™|EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
16306639|NCT00600301|Drug|Triamcinolone Acetonide and Bevacizumab|
16306640|NCT00600288|Drug|diquafosol tetrasodium Ophthalmic Solution, 2%|1-2 drops administered in each eye 4 times a day for 6 weeks
16306641|NCT00600288|Drug|Non-preserved saline solution (Placebo)|1-2 drops administered in each eye 4 times a day for 6 weeks
16306642|NCT00600275|Drug|BGT226|
16306643|NCT00600262|Drug|intravitreal bevacizumab|
16306644|NCT00600249|Drug|Cetuximab|dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks
16306645|NCT00600249|Drug|Docetaxel|100mg/m2 every 21 days 6 cycles of 21 days
16306646|NCT00600236|Procedure|blood sample|
16306647|NCT00600223|Behavioral|questionnaires and standardized, digital voice recording|Patient will be asked to complete four sets of forms. Upon completion of these forms, the study subject and the investigator will proceed to a quiet room for the standardized, digital voice recording. Recording will be made on digital audiotape using a standardized portable, digital audio recorder.
16306648|NCT00600210|Drug|Bevacizumab|Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.
16306697|NCT00599898|Drug|Nifedipine|Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
16306649|NCT00600210|Drug|Carboplatin|Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.
16306650|NCT00600210|Radiation|Radiation Therapy|"Whole pelvis will be treated to a total dose of 45 Gy in 5 weeks.
~Cesium will be used with standard intracavitary systems preferably in two intracavitary applications. An effort should be made to deliver a minimum cumulative external and intracavitary dose to Point A of 85 Gy in 2 insertions."
16306651|NCT00600197|Behavioral|back school|A kind of educational program for low back pain
16306652|NCT00600171|Drug|GW642444M|GW642444M
16306653|NCT00600171|Drug|Placebo|Placebo mulit-dose dry powder inhaler
16306654|NCT00600158|Drug|bupivacaine with hydromorphone|bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h
16306655|NCT00600158|Drug|lidocaine|lidocaine 2 mg/min intravenously (or 3 mg/kg in patients > 70 kg)
16306656|NCT00600145|Drug|Mirtazapine|15 mg Mirtazapine is administered followed 2 hours later by 20 mg of methamphetamine / placebo (administered at each testing visit)
16306657|NCT00600145|Other|Placebo|Placebo
16306658|NCT00600119|Drug|placebo|placebo, oral, once daily (QD)
16306659|NCT00600119|Drug|NKTR-118|5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
16306660|NCT00600106|Drug|1/10 NA/EE|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)
16306661|NCT00600106|Drug|Placebo|1 mg placebo
16306662|NCT00600093|Drug|Amantadine|IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
16306663|NCT00600080|Device|etafilcon A|contact lens worn daily for one week (first or second week depending on arm)
16306664|NCT00600080|Device|nelfilcon A|Contact lens worn daily for one week (first or second week depending on arm)
16306665|NCT00600067|Drug|Phentermine/Topiramate|phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
16306666|NCT00600067|Drug|Placebo|Oral placebo capsules, once daily, 28 weeks
16306667|NCT00600054|Biological|nimotuzumab (anti EGFR humanized monoclonal antibody)|150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
16306668|NCT00600041|Drug|Pantoprazole|80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
16306669|NCT00600041|Drug|Placebo|Identical infusion manner like experimental arm
16306670|NCT00600028|Drug|Thalidomide|Thalidomide 50 - 100 mg by mouth daily
16306671|NCT00600028|Drug|Placebo|Placebo 50-100 mg by mouth per day
16306672|NCT00600015|Drug|Erlotinib + Sorafenib|Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.
16306673|NCT00600015|Drug|Erlotinib + Placebo|Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.
16306674|NCT00600002|Biological|GM-CSF|Cohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral.
16306675|NCT00599989|Procedure|adjuvant therapy|
16306676|NCT00599989|Procedure|conventional surgery|
16306677|NCT00599989|Radiation|3-dimensional conformal radiation therapy|
16306678|NCT00599989|Radiation|brachytherapy|
16306679|NCT00599989|Radiation|intracavitary balloon brachytherapy|
16306680|NCT00599989|Radiation|proton beam radiation therapy|
16306681|NCT00599976|Procedure|Pulmonary vein isolation|Pulmonary vein isolation
16306682|NCT00599963|Drug|paricalcitol|paricalcitol 1 mg/day
16306683|NCT00599950|Drug|Mitomycin C and Photorefractive keratectomy (PRK)|Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
16306684|NCT00599937|Drug|ATRA|early introduction of ATRA
16306685|NCT00599937|Drug|ATRA and or Chemo as maintenance|patients were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally), according to a 2-by-2 factorial design stratified on the initial induction treatment group
16306686|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
16306687|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
16306688|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
16306689|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
16306690|NCT00599924|Drug|sunitinib + FOLFOX|50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
16306691|NCT00599924|Drug|sunitinib + FOLFOX|37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
16306692|NCT00599924|Drug|sunitinib + FOLFOX|25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
16306693|NCT00599911|Drug|Lu AA24530|per oral, once daily for 6 weeks
16306694|NCT00599911|Drug|Duloxetine|per oral, once daily for 6 weeks
16306695|NCT00599911|Drug|Placebo|per oral, once daily for 6 weeks
16306696|NCT00599898|Drug|Atosiban|Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
16306698|NCT00599885|Drug|telmisartan|telmisartan 40-80mg once per day for 8 months
16306699|NCT00599885|Drug|valsartan|valsartan 80-160mg once per day for 8 months
16306702|NCT00599859|Dietary Supplement|lactose|consumption of 50g lactose/day in 2 divided doses mixed in water.
16306703|NCT00599859|Dietary Supplement|lactose|consumption of lactose 50g/day in 2 divided doses mixed in water
16306704|NCT00599833|Biological|cetuximab|
16306705|NCT00599833|Radiation|3-dimensional conformal radiation therapy|
16306706|NCT00599820|Drug|Intravitreal Bevacizumab|
16306707|NCT00599807|Dietary Supplement|Vitamin D3 (cholecalciferol)|the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)
16306708|NCT00599781|Genetic|gene transduced PBL and/or gene transduced HSC|infusions of autologous PBL and/or HSC transduced with retroviral vectors encoding ADA
16306709|NCT00599768|Other|ID-Pain DN4 Questionnaire|This is a non-interventional questionnaire validation study
16306710|NCT00599755|Radiation|Comparator: CT or MRI and FDG-PET|Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.
16306711|NCT00599755|Drug|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.
16306712|NCT00599742|Behavioral|Balance training|Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
16306713|NCT00599742|Behavioral|Motor training|Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
16306714|NCT00599716|Drug|sodium hyaluronate|a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation
16306715|NCT00599716|Drug|vehicle|identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate
16306716|NCT00599703|Other|fMRI Scan, pre- and post language evaluation|All subjects will undergo functional MR imaging, pre- and post-surgical language evaluation, and electrocortical stimulation mapping. The brain tumor patients will undergo these procedures twice.
16306717|NCT00599690|Procedure|Epi-LASK|10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
16306718|NCT00599677|Other|acupuncture|Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
16306719|NCT00599677|Drug|Itopride|Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.
16306720|NCT00599664|Drug|OMS201|OMS201 irrigation solution during surgery
16306721|NCT00599664|Drug|Vehicle|Vehicle irrigation solution during surgery
16306722|NCT00599651|Device|Surfactant administered via Laryngeal Mask Airway (LMA)|Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.
16306723|NCT00599651|Other|standard of care (nasal CPAP and supplemental oxygen)|Standard of care will be utilized which may mean surfactant is administered
16306724|NCT00599638|Drug|pregabalin|75mg bid titrating to 150mg bid on day 4
16306725|NCT00599638|Drug|pregabalin/PF-00489791|Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
16306726|NCT00599638|Drug|Placebo|Placebo
16306727|NCT00599625|Drug|Pravastatin|80mg administered daily for 6 consecutive weeks
16306728|NCT00599612|Drug|GW856553|A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution.
16306729|NCT00599599|Behavioral|Prolonged Exposure Therapy|Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.
16306730|NCT00599586|Other|acupuncture|Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
16306731|NCT00599573|Drug|ondansetron|Ondansetron 4mg BID for six weeks
16306732|NCT00599560|Genetic|vasopressin, V2 receptor and cyclic AMP|plasma vasopressin, V2 receptor, cyclic AMP
16306733|NCT00599547|Procedure|Allogeneic Stem Cell Transplantation|Allogeneic Stem Cell Transplantation after dose-reduced Conditioning for Myelofibrosis Patients
16306734|NCT00599534|Drug|Montelukast|4 mg oral tablets
16306735|NCT00599534|Drug|Placebo|5mg tablets
16306736|NCT00599521|Drug|Adapalene lotion 0.1%|Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
16306737|NCT00599521|Drug|Adapalene Lotion Vehicle|Vehicle will be applied topically to the face, once a day, for 12 weeks
16306738|NCT00599508|Dietary Supplement|Concord grape juice|Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.
16306739|NCT00599508|Dietary Supplement|placebo juice|several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight
16306740|NCT00599508|Dietary Supplement|blueberry juice|wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
16306741|NCT00599508|Dietary Supplement|whole fruit blueberry powder|whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
16306742|NCT00599508|Dietary Supplement|berry placebo powder|berry placebo powder administered daily for 16 weeks
16306743|NCT00599495|Procedure|allogeneic HSCT|dose-reduced conditioning regimen
16306744|NCT00599482|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far infrared radiation for 30 to 40 minutes during each session.
16306745|NCT00599469|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared radiation for 30 to 40 minutes per treatment session.
16306746|NCT00599456|Dietary Supplement|Omega 3 fatty acid vitamins|Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
16306747|NCT00599456|Dietary Supplement|Placebo capsules|Placebo capsules,2 capsules, by mouth, daily for 3 months
16306748|NCT00599443|Biological|Seasonal cell-derived influenza vaccine|0.5 mL im, single dose
16306749|NCT00599443|Biological|Placebo Comparator|0.5 mL im, single dose
16306750|NCT00599430|Dietary Supplement|Placebo|Inert excipient
16306751|NCT00599430|Dietary Supplement|Lactobacillus acidophilus NCFM|1e10 CFU/day
16306752|NCT00599430|Dietary Supplement|Combination of Lactobacillus acidophilus and Bifidobacterium lactis|1x10e10 CFU/day
16306753|NCT00599417|Drug|Bacterial Lysates|Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug
16306754|NCT00599417|Drug|placebo|placebo controlled
16306755|NCT00599404|Drug|PN400|500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
16306756|NCT00599391|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation for 30 to 40 minutes per session.
16306757|NCT00599378|Behavioral|Implementation Intentions-based telephone counseling|Implementation Intentions-based telephone counseling
16306758|NCT00599365|Other|Pharmacy care arm|"The pharmacist will take all your medication bottles, and give you medication boxes filled with your medications in the order you should take them in.
~You will need to give a complete list of medications to the pharmacist.
~You will need to describe how you take these medications.
~The pharmacist will teach you about the medications. This includes side effects, drug interactions, and directions.
~The pharmacist will give you a medication schedule, and other papers about your medications."
16306759|NCT00599352|Dietary Supplement|magnesium|Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)
16306760|NCT00599326|Drug|Deferasirox|250 mg of deferasirox once daily for 6 months
16306761|NCT00599313|Drug|Sunitinib|50 mg/day orally each of Days 1-28 of each 6 week cycle
16306762|NCT00599287|Drug|Haloperidol|Haloperidol 2,5 mg. 2 dd 1, oral. (if patient is 69 years or younger) Haloperidol 1 mg. 2 dd 1, oral (if patient is 70 years or older)
16306763|NCT00599287|Drug|Methylphenidate|Methylphenidate 5 mg. 2 dd 1, oral, increased every day with 10 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 30 mg./day
16306764|NCT00599287|Drug|Rivastigmine|Rivastigmine 1,5 mg. 2 dd 1, oral, increased every third day with 3 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 12 mg./day
16306765|NCT00599274|Drug|Interferon beta-1a|injection once a week
16306766|NCT00599274|Drug|Interferon beta-1a|injection three times a week
16306767|NCT00599261|Procedure|ICD/pacemaker pocket revision|Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
16306768|NCT00599248|Biological|TissueGene-C|TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
16306769|NCT00599248|Biological|Placebo|Placebo control (DMEM)
16306770|NCT00599235|Drug|sildenafil|50mg 3 times daily for 7 days
16306771|NCT00599235|Drug|hydralazine|25mg 3 times daily for 7 days
16306772|NCT00599235|Drug|placebo|3 times daily for 7 days
16306773|NCT00599222|Biological|ranibizumab|0.5 mg intravitreal injection
16306774|NCT00599222|Procedure|TTT|Transpupillary thermotherapy (TTT)
16306775|NCT00599222|Procedure|Sham TTT|Sham Transpupillary thermotherapy (TTT)
16306776|NCT00599209|Other|clinical decision support|CDS is provided to prescribers on intervention units upon ordering medication which offers advice on prescribing and monitoring practices
16306777|NCT00599196|Drug|Rotigotine|"Rotigotine trans-dermal patches, once daily:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
~Optimal dosing:
~During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
~After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours."
16306778|NCT00599183|Other|MRI-Diffusion Tensor Imaging and Tractrography|MRI scan: Baseline: Conventional MRI (as part of clinical care) with additional diffusion tensor imaging (DTI)sequence (research). 6-week follow up: MRI with DTI and tractography as part of the research
16306779|NCT00599170|Drug|Rituximab|375 mg/m2 IV
16306780|NCT00599144|Procedure|videolaparocholecystectomy|Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
16306781|NCT00599144|Procedure|videolaparocholecystectomy|Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
16306782|NCT00599144|Procedure|videolaparocholecystectomy|Group3: control group without any local anesthetic use.
16306783|NCT00599131|Drug|Cisplatin|1. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a < 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk features (i.e. extracapsular spread, > 2 positive lymph nodes, perineural invasion, or positive margins). Cisplatin will either be dosed a 100 mg/m2 every 21 days or 40 mg/m2 weekly at the discretion of the prescribing physician.
16306784|NCT00599131|Drug|Cetuximab|1. Cetuximab will be administered at 400 mg/m2 on Day 20 (2 hour administration). 2. Cetuximab will be administered in combination with radiation therapy to those subjects who had a Partial or Complete response after the first cycle of the chemotherapy regimen is administered. The dosage for these administrations is 250 mg/m2 over sixty minutes and it will be administered for six weeks.
16306785|NCT00599131|Drug|5-Fluorouracil|5-FU will be administered 750 mg/m2 in 0.9% normal saline as a 24-hour continuous infusion, days #1-4.
16306786|NCT00599131|Drug|Docetaxel|75 mg/m2 by I.V. over one hour on Day # 1 only
16306787|NCT00599105|Procedure|magnetic resonance imaging|MRI contrast agent, 0.1 mmol/kg
16306788|NCT00599079|Drug|Azithromycin|Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
16306789|NCT00599066|Device|study cases|Application of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia.
16306790|NCT00599053|Drug|Azithromycin|10 mg/kg IV per dose given for 10 days
16306791|NCT00599040|Behavioral|The DASH diet with weight loss|A reduced calorie diet is provided to participants based on the DASH diet.
16306792|NCT00599040|Behavioral|The DASH diet without weight loss|participants are given a weight maintainenance diet based on the DASH diet
16306793|NCT00599040|Behavioral|Dairy diet|participants are given a high dairy, reduced calorie diet
16307007|NCT00597207|Other|Manual|Manual chest compression
16306794|NCT00599027|Drug|Mometasone furoate nasal spray (MFNS)|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
16306795|NCT00599027|Drug|Placebo nasal spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
16306796|NCT00599001|Drug|SD-101|Single subcutaneous escalating dose
16306797|NCT00599001|Drug|placebo|placebo
16306798|NCT00598988|Procedure|traditional Chinese acupuncture|10 treatments over 6 weeks
16306799|NCT00598988|Other|standard medical care|standard care as provided by primary physician
16306800|NCT00598975|Drug|NKTR-102 100 mg/m2|"NKTR-102 100 mg/m2 + Cetuximab Arm:
~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
16306801|NCT00598975|Drug|NKTR-102 125 mg/m2|"NKTR-102 125 mg/m2 + Cetuximab Arm:
~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."
16306802|NCT00598975|Drug|Cetuximab|Cetuximab was administered once weekly via a 2-hour IV infusion at a starting dose of 400 mg/m2 on Day 1 and subsequently administered weekly at 250 mg/m2 via a 1-hour infusion thereafter.
16306803|NCT00598962|Drug|Azithromycin|Dosage dependent on clinical factors such as age, weight and patient-specific health status
16306804|NCT00598962|Drug|Rifabutin/rifampin|
16306805|NCT00598936|Device|CDI 1000 COM and INVOS 5100|CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.
16306806|NCT00598923|Drug|topiramate|100 mg twice per day for 3 months
16306807|NCT00598923|Drug|topiramate|100 twice per day for 6 days after loading dose of phenytoin
16306808|NCT00598923|Drug|phenytoin|loading dose of 20 mg/kg and then 300 mg/day for total of 7 days
16306809|NCT00598910|Drug|Omacor|n-3 PUFA
16306810|NCT00598910|Drug|Placebo|Placebo
16306811|NCT00598897|Drug|clarithromycin, rifabutin|Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
16306812|NCT00598884|Behavioral|Internet-Based Self-Management for Prolonged Grief Symptoms|The treatment consists of empirically derived cognitive behavioral therapy strategies to promote stable and active routines, self-care, accommodation of loss, enhanced self-efficacy, re-engagement in pleasurable activities, and reattachment with significant others. Treatment sessions will be Internet-based and will occur three times per week for 6 weeks.
16306813|NCT00598871|Drug|Thymosin Beta 4 (Tβ4)|There are 2 groups: active drug and placebo. The patients in the active arm receive an administration of 0.01% Tβ4 (w/w) eyedrops to the affected eye, 2 drops 4 times daily (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
16306814|NCT00598871|Other|Placebo|There are 2 groups: active drug and placebo. The patients in the placebo arm receive an administration of 0.00% Tβ4(w/w) eyedrops to the affected eye, 2 drops four times a day (QID) (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
16306815|NCT00598858|Drug|Docetaxel|Given IV
16306816|NCT00598858|Drug|Prednisone|Given PO
16306817|NCT00598845|Procedure|Tumor biopsy study|Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.
16306818|NCT00598832|Drug|Adapalene lotion 0.1%|Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
16306819|NCT00598832|Drug|Adapalene Lotion Vehicle|Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
16306820|NCT00598819|Device|CDI 1000 COM|CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
16306821|NCT00598806|Drug|Apaziquone|A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
16306822|NCT00598806|Drug|Placebo|A single intravesical dose of placebo instilled into the bladder post-TURBT
16306823|NCT00598806|Procedure|TURBT|TransUrethral Resection of the Bladder Tumor
16306824|NCT00598793|Drug|biphasic insulin aspart|
16306825|NCT00598793|Drug|insulin glargine|
16306826|NCT00598793|Drug|metformin|
16306827|NCT00598793|Drug|pioglitazone|
16306828|NCT00598741|Other|DCE-MRI|"Patients will undergo DCE-MRI prior to, and within 18-24 days of starting chemotherapy. These studies are designed to determine if the DCE-MRI data will provide an a priori or early prognostic marker of tumor response. The dynamic MRI is done on a standard clinical scanner using standard techniques described below.
~MR imaging studies will be acquired on a 1.5T GE (Milwaukee,WI) Signa LX scanner."
16306829|NCT00598728|Behavioral|Quality of Life Questionaires|A patient questionnaire, which includes questions on medical morbidities and QOL, will be mailed to participants.
16306830|NCT00598715|Device|Sirolimus eluting stent|Sirolimus-eluting stent will be implanted
16306831|NCT00598715|Device|Paclitaxel-eluting stent|Paclitaxel-eluting stent will be implanted
16306832|NCT00598702|Drug|IV Acetaminophen|Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
16306833|NCT00598689|Drug|0.3% hypromellose|0.3% hypromellose four times a day for 5 days prior to LASIK surgery
16306834|NCT00598676|Device|biodegradable polymer Rapamycin-eluting stent|due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
16306835|NCT00598676|Device|permanent polymer rapamycin-eluting stent (Cypher)|due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
16306836|NCT00598676|Device|permanent polymer everolimus-eluting stent (Xience, Promus)|due to randomization, everolimus-eluting stent with permanent polymer will be implanted
16306837|NCT00598663|Device|insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)|6 months of pump plus continuous glucose sensing in conjunction to SMBG
16307403|NCT00593554|Biological|Rabbit ATG|2.5 mg/kg/d on Day -5 to -2
16306838|NCT00598663|Device|insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)|insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
16306839|NCT00598650|Drug|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
16306840|NCT00598637|Device|Everolimus-eluting stent (Xience)|stent is implanted due to randomization
16306841|NCT00598637|Device|Zotarolimus-eluting stent (Endeavor Resolute)|stent is implanted due to randomization
16306842|NCT00598624|Drug|Treosulfan IV|Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
16306843|NCT00598611|Drug|desloratadine|singel dose, oral, 20 mg
16306844|NCT00598611|Drug|desloratadine|single dose, oral, 5 mg
16306845|NCT00598585|Drug|Sildenafil (Viagra)|25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.
16306846|NCT00598585|Drug|Placebo|Placebo pills 3X/day for 6 weeks
16306847|NCT00598572|Drug|Deferoxamine Mesylate|Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of patient's weight), administered daily by IV infusion for three consecutive days.
16306848|NCT00598559|Drug|IV Acetaminophen|Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
16306849|NCT00598546|Behavioral|EORTC QLQ-C30, QLQ-STO22, and MSK-10|QLQ-C30 is the generic QOL tool for patients with cancer undergoing clinical trials.QLQ-STO22, containing 22 questions specific to gastric cancer, is currently the only standardized disease-specific questionnaire to measure the QOL of gastric cancer and must be used in conjunction with the QLQ-C30.MSK-10 consists of ten additional questions that were developed by surgeons on the GMT service to answer specific questions about outcomes related to proximal subtotal, distal subtotal, and total gastrectomies. These questions focus on eating capabilities, work status and major life changing events.
16306850|NCT00598533|Device|Rapamycin + Probucol-eluting stent (ISAR stent)|due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
16306851|NCT00598533|Device|polymer based Zotarolimus-eluting stent (Endeavor Resolute)|due to randomization, Zotarolimus-eluting stent with polymer will be implanted
16306852|NCT00598507|Drug|ZK-EPO|Participants were treated with 16 mg/m^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity.
16306853|NCT00598481|Genetic|Gene Therapy|Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
16306854|NCT00598481|Drug|Busulfan|Busulfan is used for non-myeloablative conditioning
16306855|NCT00598481|Drug|PEG-ADA|polyethylene glycol (PEG)-ADA is discontinued prior to gene therapy
16306856|NCT00598442|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
16306857|NCT00598442|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16306858|NCT00598442|Drug|Darbepoetin alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16306859|NCT00598429|Drug|Inhaled Prostaglandin E1|Delivery of one dose of either high dose PGE1 (300 ng/kg/min), low dose PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug) via nebulizer over a 72-hour period
16306860|NCT00598416|Behavioral|Family-Responsive Psychoeducation Program (PERF)|Group psychoeducation for HCV patients and their primary caregiver.
16306861|NCT00598403|Drug|cefditoren pivoxil|400 mg, oral, single dose during 3 days
16306862|NCT00598403|Drug|Ciprofloxacin|250 mg, oral, twice a day for 3 days
16306863|NCT00598390|Drug|[11C]MePPEP|
16306864|NCT00598377|Drug|Tetracosactin|1 microgram tetracosactin, intravenous injection, once for the test
16306865|NCT00598338|Drug|Prucalopride|4 mg o.d.
16306866|NCT00598338|Other|Placebo|o.d.
16306867|NCT00598325|Biological|3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)|1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
16306868|NCT00598312|Drug|Leuprolide Acetate for Injectable Suspension|Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product
16306869|NCT00598299|Procedure|venous puncture|venous puncture
16306870|NCT00598299|Other|obtain serum from perripheral blood or cord blood|obtain serum from perripheral blood or cord blood
16306871|NCT00598286|Drug|[18F]FMPEP-d2|
16306872|NCT00598273|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
16306873|NCT00598273|Drug|peginesatide|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16306874|NCT00598273|Drug|Darbepoetin alfa|As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
16306875|NCT00598260|Procedure|induction of labor|study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
16306876|NCT00598247|Drug|Paclitaxel Poliglumex|Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.
16307873|NCT00589472|Other|Laboratory Biomarker Analysis|Correlative studies
16306877|NCT00598234|Drug|Celecoxib (Celebrex)|The study group received 400mg oral celecoxib about 1 hr prior to surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients received Acetaminophen 500mg qid for pain control.
16306878|NCT00598208|Drug|corifollitropin alfa|On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
16306879|NCT00598208|Drug|Follitropin beta injection|Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
16306880|NCT00598195|Drug|Ketamine|subject will then receive an intravenous bolus dose of ketamine 2 mg/kg as a rapid intravenous bolus, over less than two minutes just prior to CPB. In the non-CPB patients, ketamine will be administered just prior to the skin incision. All doses will be rounded to the nearest tenth of a milligram. Timed blood samples will be collected at standardized times after the completion of the ketamine infusion and samples will be obtained from an indwelling arterial line. Each blood sample for pharmacokinetic analysis will be 1 mL.
16306881|NCT00598169|Biological|rituximab|375mg/m2 on Day 1
16306882|NCT00598169|Drug|bortezomib|Part A: Velcade Day 1 and Day 8 of a 28-day cycle, with inter-subject dose escalation over four dose levels: 0.7 mg/m2, 1 mg/m2, 1.3 mg/m2 and 1.5 mg/m2 Part B: Velcade on Days 1 and 8 of a 21-day cycle.
16306883|NCT00598169|Drug|carboplatin|"Carboplatin will be dosed to an AUC=5, calculated using the Calvert formula (5 x [creatinine clearance + 25]; the maximum dose of carboplatin is 750 mg.
~Part A: AUC=5 (maximum 750 mg) IV administered on Day 9. Part B: AUC=5 (maximum 750 mg) IV administered on Day 2."
16306884|NCT00598169|Drug|dexamethasone|Part A: 20 mg IV on Days 8-10. Part B: 20 mg IV on Days 1-3 and on Day 8.
16306885|NCT00598169|Drug|etoposide|Part A: 100 mg/m2 IV Days 8-10. Part B: 100 mg/m2 IV daily on Days 1 to 3.
16306886|NCT00598169|Drug|ifosfamide|"Part A: 5000 mg/m2 mixed with an equal amount of Mesna as a 24 hour continuous IV infusion on Day 9.
~Part B: 5000 mg/m2 mixed with an equal dose of Mesna administered via continuous infusion for 24 hours beginning on Day 2."
16306887|NCT00598169|Genetic|polymerase chain reaction|Correlate EBV/HHV-8 viral load changes with lymphoma response. HIV and EBV/HHV-8 viral loads will be assessed on baseline, day 2, 4, and 8 of week 1 of Part A.
16306888|NCT00598169|Genetic|western blotting|Peripheral blood mononuclear cells will be collected at Day 1 prior to chemotherapy, Day 2, 4 and 8 (prior to chemotherapy) then weekly during Part A, just prior to each additional cycle of Part B and at treatment completion. Western blot using antibody specific for APOBEC3G and antibody against actin for internal control will be used to quantify APOBEC3G levels. Changes at will be compared with baseline using a paired t-test.
16306889|NCT00598156|Drug|erlotinib (Tarceva)|Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
16306890|NCT00598156|Drug|bevacizumab (Avastin)|Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
16306891|NCT00598143|Behavioral|Vignette, questionnaires and Saliva Samples|The short vignette discusses the health implications of potential molecular markers of cancer risk assessment. The questionnaire asks several multiple-choice questions to assess the participant's interest in and understanding of molecular risk assessment. Patients are instructed to swish with 10cc of Scope mouthwash and to expectorate into a sterile 50cc conical tube.
16306892|NCT00598143|Behavioral|Urine Collection, Smoking cessation treatment|Single void urine specimens (approximately 50 ml) will be collected in pre-labeled specimen containers on a 3-monthly (±1 month) basis for 12 months. Standard evidence-based therapy for smoking cessation, including behavioral therapy and pharmacological therapy, is provided.
16306893|NCT00598130|Biological|Fleece|Fibrin Patch
16306894|NCT00598117|Behavioral|Questionnaires|"Newly diagnosed patients will be assessed at four points Time 1 (prior to treatment)
~Initial QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 2 (initial post-op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS Time 3 (6 months post op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS, Time 4 (1 year post op)
~Follow up QOL form
~FACT-E, PAR, Symptom Assessment Scale, MDSS"
16306895|NCT00598104|Drug|QAX576|
16306896|NCT00598104|Drug|Placebo|
16306897|NCT00598091|Drug|gemcitabine|1000mg/m2, Days 1, 8, 15
16306898|NCT00598091|Drug|dasatinib|50mg, PO, QD
16306899|NCT00598091|Drug|gemcitabine|1000mg/m2, days 1, 8, 15
16306900|NCT00598091|Drug|dasatinib|50mg, PO, BID
16306901|NCT00598078|Drug|Sodium Oxybate|Dose 1
16306902|NCT00598078|Drug|Sodium Oxybate|Dose 2
16306903|NCT00598078|Other|Placebo|Dose 3
16306904|NCT00598065|Other|PET/CT|Synchronized PET/CT Imaging
16306905|NCT00598052|Drug|Escitalopram|10mg/day
16306906|NCT00598026|Other|Tele- follow-up|Remote transmission to the implantation centre every 3 months
16306907|NCT00598026|Other|Conventional follow-up|Visits at the implantation centre every 3 months
16306908|NCT00598013|Drug|Pioglitazone|The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
16306909|NCT00598000|Behavioral|questionnaires|"QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.
~Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits."
16306910|NCT00598000|Behavioral|questionnaires|"QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.
~Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits."
16306911|NCT00597974|Procedure|Angioplasty|(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty
16306912|NCT00597974|Device|Stent|(non-experimental) Precise™ Nitinol Self-Expanding Stent (Cordis Endovascular, Johnson & Johnson), S.M.A.R.T.® Control™ Stent (Cordis Endovascular, Johnson & Johnson), Wallstent® (Boston Scientific Medi-Tech)
16306913|NCT00597974|Other|Neurological and neuropsychological evaluations|Clinical examinations consisting of a neurological and neuropsychological evaluation
16306914|NCT00597974|Procedure|Angiography|(non-experimental) Coronary angiography
16306915|NCT00597948|Behavioral|Healthy Lifestyles Curriculum|Three consecutive days of six hours of training comprised of instruction and participant interaction.
16306916|NCT00597935|Procedure|SSLF|sacrospinous ligament fixation (SSLF)
16306917|NCT00597935|Procedure|ULS|uterosacral vaginal vault ligament suspension (ULS)
16306918|NCT00597935|Behavioral|PMT|Pelvic muscle training and exercises (PMT)
16306919|NCT00597909|Drug|sodium phenylacetate and sodium benzoate injection 10% / 10%|5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
16306920|NCT00597909|Drug|sodium phenylacetate and sodium benzoate injection 10% / 10%|2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
16306921|NCT00597909|Drug|placebo solution (10% dextrose)|Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
16306922|NCT00597896|Drug|pramipexole|po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
16306923|NCT00597870|Device|Endoluminal treament of thoracic lesions|Endoluminal treament of thoracic lesions with a thoracic stent-graft
16306924|NCT00597857|Drug|Hydrocortisone|Participants will receive a tapering low-dose of hydrocortisone in pill form for 10 days, twice a day, after the trauma.
16306925|NCT00597857|Drug|placebo|receipt of a placebo pill for 16 days
16306926|NCT00597844|Other|voice evaluation and fMRI|will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.
16306927|NCT00597844|Other|undergo voice evaluation and fMRI prior|in approximately one month and six months
16306928|NCT00597818|Drug|Cobiprostone|18 mcg cobiprostone capsules for oral administration
16306929|NCT00597818|Drug|Placebo|Matching placebo capsules for oral administration
16306930|NCT00597818|Drug|Non-steroidal anti-inflammatory drug|Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
16306931|NCT00597805|Behavioral|questionnaires/interviews|All patients who agree to participate will be interviewed for a baseline quality of life assessment prior to surgery. A brief in hospital interview will follow in the peri-operative period. In the ensuing months, patients will be interviewed at approximately 3, 6 and 12 months post-operatively (eg: 3 month interview will be done between 8-16 weeks and 6 month interview between 20-28 months post-operatively). Annual interviews in years two through five will be employed to determine areas for future study and solicit narrative on transition toward cancer survivorship.
16306932|NCT00597792|Device|NDO Full-thickness Plicator|A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
16306933|NCT00597779|Device|Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)|Surgical stabilization of unstable intertrochanteric hip fractures using two commonly used implant categories
16306934|NCT00597766|Drug|Lidocaine|One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
16306935|NCT00597766|Drug|Triamcinolone + Lidocaine|Low Dose -- One-time injection of 20 mg triamcinolone: 1.5 cc of normal saline, 0.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
16306936|NCT00597766|Drug|Triamcinolone + Lidocaine|Standard Dose -- One-time injection of 40 mg triamcinolone: 1 cc of normal saline, 1 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
16306937|NCT00597766|Drug|Triamcinolone + Lidocaine|High Dose -- One-time injection of 60 mg triamcinolone: 0.5 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
16306938|NCT00597753|Drug|peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
16306939|NCT00597753|Drug|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
16306940|NCT00597727|Drug|Peanut SLIT|Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
16306941|NCT00597727|Drug|Placebo SLIT|Liquid glycerin without peanut which are dosed under the tongue.
16306942|NCT00597714|Drug|Non-myeloablative Stem Cell Transplantation|The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. Group B's prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Patient evaluations will occur 2 times per week by physical exam for toxicity through day 45.
16306943|NCT00597701|Drug|Baclofen|Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
16306944|NCT00597701|Drug|Placebo|Placebo
16307008|NCT00597194|Procedure|Hernia repair|Hernia repair laparoscopically (LH) or by open operation (OH)
16306945|NCT00597701|Drug|Lorazepam|"Lorazepam was provided to all subjects (both arms of the study), as indicated by clinical condition. Standard symptom-triggered dosing of lorazepam for alcohol withdrawal was used. That is, the size and the frequency of the dose of lorazepam was determined by the severity of the alcohol withdrawal symptoms."
16306946|NCT00597688|Drug|Chlorhexidine gel|Oral mucosal application of chlorhexidine gel
16306947|NCT00597688|Drug|Placebo gel|Oral mucosal application of placebo gel
16306948|NCT00597675|Biological|Peanut OIT|Defatted peanut flour ingested daily as oral mucosal immunotherapy
16306949|NCT00597675|Biological|Placebo|Oat flour matched by weight and consistency that is ingested daily as a placebo
16306950|NCT00597662|Device|polylactide-caprolactone-trimethylenecarbonate copolymer|Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
16306951|NCT00597662|Device|Icodextrin 4%|1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
16306952|NCT00597649|Drug|Bicifadine|SR dosage form of 400 mg bid or tid for one year
16306953|NCT00597636|Behavioral|Questionaire, blood sample|Provide 30ml blood for laboratory assays Complete Health Questionnaire
16306954|NCT00597636|Behavioral|Questionaire, Blood sample|Provide 30ml blood for laboratory assays Complete Health Questionnaire
16306955|NCT00597623|Other|Adalimumab (Humira®)|syringes for injections under cutaneous dose = 40mg vol = 0.8 ml
16306956|NCT00597623|Other|Placebo|syringes under cutaneous vol = 8 ml
16306957|NCT00597610|Other|Transrectal ultrasound 3-D (TRUS)|Transrectal ultrasound (TRUS) is widely accepted as an accurate and effective technique for staging of rectal cancer. The decision to administer pre-operative chemotherapy/radiation therapy is often made based on the results of the TRUS. Three-dimensional TRUS (3-D TRUS) is a new modality that provides all of the information of traditional TRUS as well as the ability to provide three dimensional views of the tumor.
16306958|NCT00597597|Drug|Erlotinib|During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
16306959|NCT00597584|Drug|peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
16306960|NCT00597584|Drug|Epoetin alfa or Epoetin beta|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.
~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
16306961|NCT00597558|Drug|Egg white protein|Egg white protein powder
16306962|NCT00597545|Procedure|Carotid endarterectomy|When a shunt is inserted to increase blood flow to the brain
16306963|NCT00597545|Device|Shunt|A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.
16306964|NCT00597532|Dietary Supplement|Soy|soy (soy protein supplementation 50 grams/day)
16306965|NCT00597532|Dietary Supplement|Milk|placebo (milk protein supplementation 50 grams/day)
16306966|NCT00597519|Drug|Fludarabine, Cyclophosphamide|"Fludarabine 25 mg/m2/day IV in the morning x 3 days (days -7, -6 and -5) for a total dose of 75 mg/m2 followed by Cyclophosphamide on days -6 and -5. 60mg/kg/day IV over 30-60 minutes x 2 days (days -6 and -5). High volume fluids should commence approximately 12 hours prior to drug and continue until 24 hours after second dose.
~Total Body Irradiation: 125 cGy x 11 doses (TID on days -3, -2, -1 and BID on day 0) for a total TBI dose of 1375 cGy. Pediatric patients unable to tolerate a TID dosing schedule can receive 150 cGy x 8 doses (BID on days -3, -2, -1, and 0). All patients will receive GVHD prophylaxis with 2 drugs: Cyclosporine A and Mycophenolate mofetil (MMF).
~Units should be given consecutively each over approximately 10-30 minutes.Pre-medication should include acetaminophen and diphenhydramine or hydroxyzine.G-CSF 5 mcg/kg/day IV/SQ (dose rounded to vial size to a maximum of 480 mcg) will be given from day +1 until ANC recovery."
16306967|NCT00597519|Procedure|Transplantation|The UCB ( Umbilical Cord Blood) collection known as a unit is processed to remove excess plasma and red cells, tested for sterility, HLA-typed, cryopreserved and stored. This protocol involves the administration of two UCB units from two different donors. The units will be thawed in the Cytotherapy Laboratory as per the current standard operating procedure.
16306968|NCT00597506|Drug|Bevacizumab|10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle
16306969|NCT00597506|Drug|Everolimus|10 mg Everolimus(RAD001) daily by mouth, days 1-28
16306970|NCT00597493|Drug|Sorafenib and Temozolomide|Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).
16306971|NCT00597480|Drug|rhGH (Norditropine SimpleXx®)|the recommended dose in the EU of rhGH (Norditropine SimpleXx®
16306972|NCT00597480|Drug|rhGH norditropine simple Xx|"the dose to achieve a treat-to target value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day)"
16306973|NCT00597467|Device|VISA (comfilcon A) Silicone Hydrogel Soft contact lens|Test device
16306974|NCT00597467|Device|Acuvue 2 Soft Contact Lens|Control device
16307009|NCT00597181|Procedure|Trabeculectomy with mitomycin c|mitomycin c 0.2 mg/cc for 2 minutes
16307010|NCT00597181|Procedure|Ex-Press mini shunt with mitomycin c|mitomycin c 0.2 mg/cc for 2 minutes
16307118|NCT00596258|Drug|A-007|applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix
16307119|NCT00596245|Drug|MT400|MT 400, naproxen sodium 550mg
16307120|NCT00596219|Drug|celecoxib|celecoxib
16306975|NCT00597454|Other|Patient Navigation|"we will conduct a detailed analysis of how the patient navigators' time is actually utilized by having them record a detailed log categorizing their activities as it relates to the elimination of recognized barriers to care. Second, we will measure the time interval from receipt of a suspicious mammogram to appropriate diagnostic evaluation and or treatment.
~We will measure the number of women who experience diagnostic and or treatment delay and whether the presence of a Patient Navigator enables delivery of coordinated care that avoids delays. Third, we will measure patients' satisfaction with aspects of their care, focusing particularly on care coordination using validated instruments designed for this purpose."
16306976|NCT00597441|Biological|Thymic Transplantation for Recipients of UCB transplant|Subjects with hematologic malignancies or bone marrow failure disorders will undergo umbilical cord blood transplantation and two months post transplant will have thymic tissue from a third party donor transplanted into the thigh muscle.
16306977|NCT00597428|Drug|Lubiprostone|24 mcg capsules twice daily (BID)
16306978|NCT00597428|Drug|Placebo|0 mcg capsules twice daily (BID)
16306979|NCT00597415|Drug|celecoxib|celecoxib 200mg
16306980|NCT00597415|Drug|placebo|placebo
16306981|NCT00597402|Drug|Avastin|Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.
16306982|NCT00597402|Drug|Temozolomide|Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.
16306983|NCT00597402|Radiation|Radiation Therapy (XRT)|Treatment with standard XRT (radiation) for 6.5 weeks.
16306984|NCT00597402|Drug|Irinotecan|Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)
16306985|NCT00597389|Drug|Inderol (propranolol)|Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.
16306986|NCT00597376|Other|Cerefolin NAC (a medical food)|Cerefolin NAC one tablet each day
16306987|NCT00597376|Other|Cerefolin NAC placebo|Placebo tablet once a day
16306988|NCT00597363|Device|Neptune P.A.D. (R)|The Neptune Pad ® (Biotronik GmbH & Co. KG, Berlin, Germany) is a soft and hydrophilic wound dressing, which has been developed to accelerate local hemostasis, reduce compression times, enable early ambulation and minimize the risk for bleeding complications. Neptune Pad ® consists of calcium alginate, which is cationically charged and exerts potent procoagulant properties.
16306989|NCT00597363|Other|conventional manual compression|The most common technique for puncture site management is manual compression. This technique requires an extended pressure on the puncture site, and after achievement of hemostasis a pressure bandage is applied for several hours at bed rest.
16306990|NCT00597350|Dietary Supplement|Trigonella foenum-graecum (fenugreek)|2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart
16306991|NCT00597337|Behavioral|FearNot|Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)
16306992|NCT00597324|Procedure|coronary catheterisation|Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
16306993|NCT00597311|Radiation|radiotherapy|"Short term radiotherapy 5x5 Gy during 5 days
~Chemoradiotherapy 50 Gy + 5Fu/Lv"
16306994|NCT00597298|Device|Threshold|Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.
16306995|NCT00597298|Device|sham threshold|non-training physical activity
16306996|NCT00597272|Biological|KLH conjugates with GD2L and GD3L|6 vaccinations (on weeks 1, 2, 3, 8, 20 and 32) which will contain the same KLH conjugates with GD2L and GD3L. All vaccines contain KLH conjugates containing 30mcg of GD2L and 30mcg of GD3L and QS-DG or OPT-821. The initial 8 patients will receive the same QS-DG or OPT-821 vaccine dose in all of their vaccines. This dose will be 50 mcg for the first patient, 75 mcg for the second patient and 100 mcg for the third through eighth patients. In all subsequent patients the 1st, 4th and 5th vaccinations will include 150 mcg of OPT-821. The 2nd and 3rd vaccinations will contain 100 mcg of OPT-821 and the 6th vaccination will contain 200 mcg of OPT-821.
16306997|NCT00597259|Drug|Pegasys plus Entecavir|Pegasys 180 mcg in 0.5 mL solution administered sc once weekly for 24 weeks plus entecavir (0.5mg mg/capsule) 0.5 mg administered po daily for 24 weeks
16306998|NCT00597259|Drug|Entecavir|ETV 0.5 mg daily monotherapy for 144 weeks
16306999|NCT00597246|Drug|FACBC, Methionine|F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.
16307000|NCT00597246|Other|PET Scan|GE Advance PET scanner for sequential body imaging
16307001|NCT00597233|Drug|insulin aspart|
16307002|NCT00597233|Drug|soluble human insulin|
16307003|NCT00597233|Drug|insulin NPH|
16307004|NCT00597220|Dietary Supplement|Omega 3 (n-3 PUFA)|1 gram of n-3 PUFA containing DHA and EPA
16307005|NCT00597220|Drug|Placebo|Placebo
16307006|NCT00597207|Device|AutoPulse|Mechanical device that provides chest compression
16307011|NCT00597142|Device|Express™ Renal Premounted Stent System|"This device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a:
~Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery
~Lesion length ≤15mm
~Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
~RVD 4.0-7.0mm"
16307012|NCT00597129|Biological|90Y-hPAM4|Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
16307013|NCT00597116|Drug|Vinorelbine|
16307014|NCT00597116|Drug|Vandetanib|once daily oral dose
16307015|NCT00597103|Other|Cognitive Function Testing-10 Tests|Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
16307016|NCT00597103|Other|Sleep Assessment Testing|"Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously"
16307017|NCT00597103|Other|Periodic Leg Movement Syndrome Assessment|"Subjects will wear and Actiwatch on both legs for three consecutive nights."
16307018|NCT00597077|Other|Rate vs rhythm control strategies for atrial fibrillation|Rate vs rhythm control strategies for atrial fibrillation
16307019|NCT00597077|Other|Rate vs rhythm control strategies in atrial fibrillation|rate vs rhythm control strategies in atrial fibrillation
16307020|NCT00597064|Drug|prednisone|oral prednisone 40 mg/day for 15 +/- 5 days
16307021|NCT00597051|Drug|ARD-0403|
16307022|NCT00597038|Drug|Dasatinib and Dacarbazine (DTIC)|"Arm A/ Phase I Potential Dose Levels.
~Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m^2.
~Arm B/Phase II Potential Dose Levels.
~MTD1: Dasatinib 70 mg; DTIC 1000 mg/m^2. MTD2: Dasatinib 70 mg; DTIC 800 mg/m^2. MTD3: Dasatinib 100 mg: DTIC 1000 mg/m^2."
16307023|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
16307024|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days
16307025|NCT00597025|Dietary Supplement|Protein Food Bar Intelligent Indulgence|Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
16307026|NCT00597012|Procedure|Arthroscopic partial menisectomy|Arthroscopic partial meniscectomy is a surgical procedure that is performed to remove a piece of torn cartilage in the knee joint. Incisions for arthroscopy are quite small, usually about 1 centimeter each. The torn meniscus can be removed using a number of different instruments, including small shavers and scissors.
16307027|NCT00597012|Other|Standard physical therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. This physical therapy regimen will have similar elements and goals as the postoperative intervention offered to Group 1 participants.
16307028|NCT00597012|Other|Postoperative rehabilitative physical therapy|This physical therapy is geared specifically toward rehabilitation after APM surgery.
16307029|NCT00596999|Procedure|UCB and HPDSC|single dose of UCB followed by one unit of HPDSC
16307030|NCT00596986|Drug|Duloxetine|Duloxetine 30mg up to 120mg per day.
16307031|NCT00596986|Behavioral|Cognitive Behavioural Analysis System of Psychotherapy|Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.
16307032|NCT00596973|Procedure|Surgical Treatment|Ileal transposition with sleeve gastrectomy
16307033|NCT00596960|Behavioral|Motivational Enhancement Therapy (MET)|MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
16307034|NCT00596960|Behavioral|Health education|Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
16307035|NCT00596947|Drug|prednisone|In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on.
16307036|NCT00596947|Drug|rabbit antithymocyte globulin|Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection.
16307037|NCT00596947|Drug|Tacrolimus|Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study.
16307038|NCT00596947|Drug|Prednisone|Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely.
16307039|NCT00596947|Drug|Mycophenolate mofetil|Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
16307121|NCT00596206|Drug|leflunomide|20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months
16307040|NCT00596947|Drug|Mycophenolate mofetil|Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
16307041|NCT00596934|Drug|metreleptin|0.1 mg/kg/day once a day via subcutaneous injections
16307042|NCT00596895|Dietary Supplement|Isoflavone|Ingested 47 mg of isoflavone in three 8 oz servings per day
16307043|NCT00596882|Other|Message Prime|Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.
16307044|NCT00596882|Other|Message Prime|Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.
16307045|NCT00596856|Behavioral|Development and dissemination of priority oral health risk assessment and referral guidelines - PORRT|The RCT will compare passive distribution of guidelines by mail to an in-office intervention consisting of guideline distribution combined with educational outreach providing training in guideline use and patient mediated information provided by the risk and referral assessment tool (PORRT). The three-arm trial will consist of 25 medical practices that have never participated in IMB and 25 practices that are currently participating, both of which will receive the guidelines through the mail, and 25 practices currently participating in IMB that will receive the more intense in-office training intervention.
16307046|NCT00596843|Behavioral|Motivational interviewing|6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
16307047|NCT00596843|Behavioral|Educational intervention|6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
16307048|NCT00596830|Drug|CP-751,871 (Figitumumab)|CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
16307049|NCT00596830|Drug|Carboplatin|Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
16307050|NCT00596830|Drug|Paclitaxel|Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
16307051|NCT00596830|Drug|Carboplatin|Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
16307052|NCT00596830|Drug|Paclitaxel|Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
16307053|NCT00596817|Drug|Placebo|capsules, daily, orally
16307054|NCT00596817|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets, daily, orally
16307055|NCT00596804|Drug|veltuzumab|once weekly intravenous dosing for 4 weeks
16307056|NCT00596791|Drug|tafluprost|prostaglandine analoque
16307057|NCT00596778|Other|chest physiotherapy|The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion.
16307058|NCT00596765|Behavioral|Neuropsychological Cognitive Behavioral Therapy|Neuropsychological Cognitive Behavioral Therapy encompasses 2 foci: First emphasis is on neuropsychological compensatory strategies for the treatment of deficits in attention, memory, and executive functions. Secondly, cognitive behavioral intervention techniques are employed to support the patient in the process of coping with chronic illness: i.e. improve regulation of negative affect, diversify the impaired self-concept after acquired brain injury, and adjust important life-goals to changed circumstances.
16307059|NCT00596752|Drug|Alprostadil|"Active Substance: Prostaglandin E1
~Pharmaceutical Form: solution for infusion
~Concentration: 40 μg b.d.
~Route of Administration: intravenous infusion"
16307060|NCT00596752|Other|Placebo|"Active Substance: Lactose
~Pharmaceutical Form: solution for infusion
~Concentration: 40 μg b.d.
~Route of Administration: intravenous infusion"
16307061|NCT00596726|Device|IMPELLA LP/LD 5.0|IMPELLA LP/LD 5.0 Support System is intended to be used for up to seven (7) days as a left ventricular cardiac assist device for postcardiotomy patients who, despite having been weaned from cardiopulmonary bypass (CPB), require hemodynamic support
16307062|NCT00596700|Device|Given® Diagnostic System including PillCamTM SB Capsules|"Device for detection of pathologies as a tool in the diagnosis of gastrointestinal disorders.
~An ingestible,disposable video camera that transmits high quality images of the small intestinal mucosa"
16307063|NCT00596687|Drug|Insulin glargine|Insulin glargine once daily SQ
16307064|NCT00596687|Drug|Regular insulin|Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO
16307065|NCT00596687|Drug|Insulin glulisine|scheduled glulisine given SQ at mealtime TID; none given if patient NPO
16307066|NCT00596674|Behavioral|Lifestyle Counts|8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
16307067|NCT00596674|Other|Attention Control|8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
16307068|NCT00596661|Device|TriMaxx Coronary Stent placement|Angioplasty with coronary artery stent placement
16307069|NCT00596648|Drug|XL184|Capsules administered orally daily
16307070|NCT00596648|Drug|erlotinib|Tablets administered orally daily.
16307071|NCT00596635|Dietary Supplement|Once Daily Cranberry Capsule|650mg capsule pure cranberry powder
16307072|NCT00596635|Dietary Supplement|Twice Daily Cranberry Capsules|One 650mg cranberry capsule administered twice per day
16307073|NCT00596622|Drug|Lithium|Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
16307114|NCT00596284|Behavioral|Enhanced Usual Care (EUC)|Following in-person meetings, participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months.
16307115|NCT00596271|Biological|IC51|
16307116|NCT00596271|Biological|HAVRIX|
16307074|NCT00596609|Drug|Intrathecal Morphine|"In the IT morphine group, prior to IT morphine injection (within 15 minutes of the injection), the neurophysiologist will be asked to obtain a set of TceMEP recordings. The recordings collected at this time will be labeled Baseline. These will serve as controls for subsequent recording comparisons.
~In the IT morphine group, the time of IT morphine injection will be recorded, as well as the dose. A timer will be started. The neurophysiologist will then be asked to collect four additional sets of TceMEP recordings, at 5, 10, 20, and 30 minutes after morphine injection."
16307075|NCT00596596|Drug|prucalopride|0,5 mg once daily
16307076|NCT00596596|Drug|prucalopride|1 mg once daily
16307077|NCT00596596|Drug|2 mg prucalopride|2 mg once daily
16307078|NCT00596596|Drug|4 mg prucalopride|4 mg once daily
16307079|NCT00596596|Other|Placebo|placebo once daily
16307080|NCT00596583|Drug|DYME|2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
16307081|NCT00596583|Drug|DYME|2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
16307082|NCT00596570|Procedure|PCI|Percutaneous coronary interventiom
16307083|NCT00596557|Drug|everolimus|reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.
16307084|NCT00596544|Behavioral|questionnaires|will be offered referral to the Sexual Health Clinic (SHC) at MSKCC for evaluation and possible treatment. The effectiveness and compliance of the intervention offered at the SHC will be assessed at approximately 3, 6 and 12 months using the FSFI, SAQ, CES-D, MSC and IES. At each evaluation they will complete a Health Surveillance Form (HSF). They will have completed the study at 12 months after entering the study or at the time they have evidence of recurrent disease requiring treatment
16307085|NCT00596544|Behavioral|questionnaires|Those women who have a FSFI score > 26 will be reassessed at approximately 3, 6 and 12 months. They will complete the FSFI, SAQ, CES-D, IES, MSC and HSF at each assessment. They will be followed out until 12 months after entering the study or until they have evidence of recurrent disease.
16307086|NCT00596531|Drug|Acamprosate|Oral administration, 666 mg, tid, for 4 months
16307087|NCT00596531|Drug|Placebo|Oral administration of 2 pills, tid, for 4 months
16307088|NCT00596518|Drug|PF-00734200|The drug is administered as a single dose of four 5-mg tablets
16307089|NCT00596492|Drug|DYME|2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
16307090|NCT00596492|Drug|DYME|2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
16307091|NCT00596479|Drug|Filgrastim (rG-CSF)|
16307092|NCT00596466|Drug|pregabalin|pregabalin
16307093|NCT00596453|Drug|Ciprofloxacin hydrochloride|250 mg Ciprofloxacin hydrochloride twice a day for 14 days
16307094|NCT00596453|Drug|Placebo|Placebo twice a day for 14 days
16307095|NCT00596440|Drug|Transdermal nicotine patch|8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.
16307096|NCT00596427|Drug|Colesevelam HCL|Colesevelam HCL 625 mg: 3 tablets twice per day
16307097|NCT00596427|Drug|Placebo|Placebo tablets: 3 tablets twice per day
16307098|NCT00596414|Procedure|transjugular liver biopsy|liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
16307099|NCT00596414|Drug|placebo|
16307100|NCT00596414|Drug|midazolam|
16307101|NCT00596414|Drug|midazolam + pethidine|
16307102|NCT00596375|Procedure|Lubricant Instillation|Lubricant jelly instilled in urethra prior to catheterization
16307103|NCT00596375|Drug|Lidocaine Lubricant|2% Lidocaine lubricant instillation prior to urethral catheterization
16307104|NCT00596362|Drug|AVASTIN|a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
16307105|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL-Cancer Survivor FACT-Ovarian SF-36 (general QOL scale) CES-D (depression scale) Impact of Events Scale (anxiety scale) FACT-GOG-NTX (neurotoxicity scale) Female Sexual Functioning Index (FSFI) Cognition Testing Perception of disease chronicity/acuity Concerns about Recurrence Report of surveillance type, frequency, utility Health behaviors Self-report of co-morbidities Self-report of potential unmet needs Background information form List of current medications Patient-defined QoL domains
16307106|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL-Cancer Survivor FACT-Ovarian SF-36 (general QOL scale) CES-D (depression scale) Impact of Events Scale (anxiety scale) FACT-GOG-NTX (neurotoxicity scale) Female Sexual Functioning Index (FSFI) Cognition Testing Perception of disease chronicity/acuity Concerns about Recurrence Report of surveillance type, frequency, utility Health behaviors Self-report of co-morbidities Self-report of potential unmet needs Background information form List of current medications Patient-defined QoL domains
16307107|NCT00596349|Behavioral|questionnaires|study participants complete one-time survey, questionnaires, and cognition testing, comprising the following: QOL- Cancer Survivor, FACT-Ovarian, SF-36, CES-D, IES, FACT-GOG-NTX, FSFI, Cognition Testing, Perception of disease chronicity/acuity, Report of surveillance type, frequency, utility, Health behaviors, Self-report of co-morbidities, Self-report of potential unmet needs, Background information form, List of current medications,Patient-defined QoL domains
16307108|NCT00596336|Drug|Imiquimod cream|Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6
16307109|NCT00596336|Drug|influenza vaccine|trispecific influenza vaccine 0.5 ml subcutaneously
16307110|NCT00596310|Other|CT|Screening CT
16307111|NCT00596297|Drug|bevacizumab|Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
16307112|NCT00596297|Procedure|pars plana vitrectomy|4 weeks after baseline
16307113|NCT00596284|Behavioral|Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)|Cognitive behavioral therapy (CBT) will consist of 8 to 10 sessions over a period of 10 to 12 weeks. Each CBT session will last about 1 hour and will include meeting with a study staff member to discuss anxiety and how to cope with it. Participants will also complete practice activities at home for about 20 minutes per day.
16307122|NCT00596180|Drug|HBOT|total body exposure to greater than atmospheric pressure oxygen
16307123|NCT00596167|Drug|Intravenous antibiotics|Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through the venous limb of their HD access (or tunneled catheter) via an IV pump.
16307124|NCT00596154|Other|Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide|"The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.
~On day 2 you will be admitted to the hospital and will receive 3 other drugs:
~Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.
~Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle."
16307125|NCT00596141|Device|OroScience Topical Oral Wound Emulsion|TOWE will be applied 3 times daily for a period of 7 days by the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site.
16307126|NCT00596128|Behavioral|Implementation of SOP|SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine
16307127|NCT00596115|Drug|R(+) pramipexole dihydrochloride monohydrate|20 mg tid per day orally
16307128|NCT00596102|Biological|Japanese Encephalitis purified inactivated vaccine|Japanese Encephalitis purified inactivated vaccine
16307129|NCT00596076|Behavioral|Back School|"All the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed.
~A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month."
16307130|NCT00596063|Biological|Wosulin R|Penfill cartridges; Single Dose, 0.2 IU/ kg;
16307131|NCT00596063|Biological|Novolin R|Penfill cartridges; Single Dose, 0.2 IU/ kg;
16307132|NCT00596050|Drug|ketamine and midazolam|ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
16307133|NCT00596050|Drug|etomidate, fentanyl, and lidocaine|etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
16307134|NCT00596037|Drug|Growth hormone - LB03002|
16307135|NCT00596024|Dietary Supplement|lutein/zeaxanthin|daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
16307136|NCT00596024|Dietary Supplement|placebo|placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients
16307137|NCT00596011|Drug|Polyphenon E|Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.
16307138|NCT00596011|Drug|Placebo|Matching placebo BID
16307139|NCT00595985|Drug|sorafenib|sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
16307140|NCT00595972|Drug|ECF-endostar|Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
16307141|NCT00595959|Device|CLiRpath Photoablation System|Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
16307142|NCT00595946|Drug|Lubiprostone|24 mcg capsules twice daily (BID)
16307143|NCT00595946|Drug|Placebo|0 mcg capsules twice daily (BID)
16307144|NCT00595933|Other|sugar-free chewing gum|Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
16307145|NCT00595933|Other|chewing gum|Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
16307146|NCT00595933|Other|mouth rinse|Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
16307147|NCT00595933|Other|mouth rinse|Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
16307148|NCT00595933|Drug|mouth spray|Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
16307149|NCT00595933|Drug|mouth spray|Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
16307150|NCT00595920|Biological|Tovaxin|2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
16307151|NCT00595881|Device|Bedside emergency ultrasound|Ultrasound will be performed on the lesion in question.
16307152|NCT00595868|Drug|Varenicline|0.5 milligrams two times per day for 3 days, then 1.0 milligrams two times per day for an addition 11 days - 2 months
16307153|NCT00595868|Drug|Placebo|same as Varenicline arm
16307154|NCT00595855|Procedure|trabeculectomy|Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
16307155|NCT00595855|Procedure|deep sclerectomy|deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
16307156|NCT00595829|Drug|XL019|XL019 capsules administered orally
16307157|NCT00595816|Other|physical training and counselling|Neuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries
16307158|NCT00595790|Biological|IC51|
16307197|NCT00595413|Drug|Placebo matched to atacicept|Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
16307198|NCT00595413|Drug|Atacicept: with loading dose|Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
16307199|NCT00595413|Drug|Atacicept|Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
16307159|NCT00595777|Behavioral|EPAT© Educational Package|The EPAT package consists of an education programme, which deals with the known common barriers to effective pain control and the bedside pain tool. The pain tool is uniquely incorporated into the vital signs chart to enable a systematic approach to cancer pain assessment and review. EPAT consists of 2 steps: step 1 is a colour-coded pain assessment on the bedside vital signs chart. Patients with moderate or severe pain on step 1 will progress to to step 2, which helps to identify the aetiology of the pain, screening for opioid side effects and is linked via flags to simple management plans. The intervention will be delivered to the clusters randomised to the intervention, after collection of baseline data (pre-intervention data) on 50 patients.
16307160|NCT00595764|Behavioral|Manual-guided Physician Management (PM)|Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
16307161|NCT00595764|Behavioral|Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)|CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
16307162|NCT00595738|Other|Standard of care therapy for severe decompensated heart failure|Standard of care therapy for severe decompensated heart failure
16307163|NCT00595725|Other|Lymphatic Mapping|Intra-Operative Lymphatic Mapping
16307164|NCT00595712|Procedure|Iliac crest allograft|Opening wedge osteotomy of proximal tibia with allograft from iliac crest
16307165|NCT00595712|Procedure|Iliac crest autograft|open wedge osteotomy of proximal tibia using autogenous iliac bone graft
16307166|NCT00595699|Drug|escitalopram|10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
16307167|NCT00595699|Drug|placebo|Placebo
16307168|NCT00595686|Drug|SNX-5422|dose escalated; tablets every other day; undetermined duration until disease progression
16307169|NCT00595673|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
16307170|NCT00595660|Procedure|FNA - fine needle aspiration|Fine Needle aspiration
16307171|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
16307172|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
16307173|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
16307174|NCT00595660|Procedure|FNA - fine needle aspiration|Fine needle aspiration
16307175|NCT00595647|Device|Drug eluting stent|Implantation of stent
16307176|NCT00595647|Device|Bare metal stent|Implantation of stent
16307177|NCT00595621|Device|Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)|Multi-Channel Phased Gastric Pacemaker (MGP-1)
16307178|NCT00595608|Drug|Sterimar Spray|Post-op nasal spray, three times a day
16307179|NCT00595608|Drug|Generic homemade nasal saline spray (salt and water)|post op nasal saline spray in syringe, three times a day
16307180|NCT00595582|Dietary Supplement|curcumin + bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
16307181|NCT00595569|Behavioral|Flexible insulin therapy (FIT)|Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each
16307182|NCT00595556|Drug|zonisamide|flexible dosages of 100-500mg/day
16307183|NCT00595556|Drug|Placebo|Placebo
16307184|NCT00595543|Drug|Bromfenac|1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
16307185|NCT00595543|Drug|Ketorolac|1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
16307186|NCT00595543|Drug|Diclofenac|1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
16307187|NCT00595530|Drug|ketamine|"Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.
~Dosing Regimen:
~Patients begin the ketamine infusion at 0.05 mg/kg/hr.
~4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if:
~patient's pain has not improved to an acceptable level
~side effects remain acceptable
~4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr
~4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
~Maximum dose of ketamine is limited to 300 mg per 24 hrs
~Patient may receive ketamine up to 72 hrs after initiation."
16307188|NCT00595517|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg once daily
16307189|NCT00595504|Drug|Ramelteon|Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.
16307190|NCT00595504|Drug|Placebo|Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
16307191|NCT00595491|Biological|Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage|Bronchoalveolar lavage is performed in the lingula without instillation of diluent or allergen. A 2ml aliquot of diluent is instilled into the right upper lobe. The procedure is repeated in the right middle lobe with instillation of 2ml of Cat or Mite allergen. A test dose of allergen is administered first. This will consist of 2ml allergen at 1/10th the threshold concentration for Cat or DF Mite Allergen or at 1/30th the threshold concentration for DP Mite Allergen. If on visual inspection through the bronchoscope there is no evidence of reaction to the test dose, a 2nd allergen challenge is done in the right middle lobe using 2ml of full-dose allergen. After a 1,6, or 24hr recovery period, a single 2nd bronchoscopy is performed after delivery of allergen extract and diluent and 1 Tbsp of blood is obtained. Bronchoalveolar lavage will be obtained from the lobes in which the diluent and allergen were instilled. OFDI and endobronchial brushing of the airways will also be performed.
16307192|NCT00595478|Behavioral|Motivational Enhancement Therapy (MET)/CBT+CM|Behavioral Treatment
16307193|NCT00595478|Behavioral|Motivational Enhancement Therapy (MET)/CBT|Behavioral Treatment
16307194|NCT00595465|Biological|Japanese Encephalitis purified inactivated vaccine|IC51 6 mcg i.m. injection on Day 0 and Day 28
16307195|NCT00595426|Drug|YM150|Oral
16307196|NCT00595426|Drug|Warfarin|Oral
16307200|NCT00595413|Biological|Adalimumab|Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
16307201|NCT00595387|Other|Supportive Psychotherapy|Participants will attend 18 supportive therapy sessions over 5 months. Supportive psychotherapy focuses on reflecting and expressing feelings about current life issues. Participants are supported and comforted when coping with difficult situations, depression, mood swings, or anger.
16307202|NCT00595387|Other|Cognitive Behavioral Therapy (CBT)|Participants will attend 18 CBT sessions over 5 months. CBT for depression targets depressive symptoms through a range of different treatments. This includes psychoeducation about the disorder and educating patients about the role of thoughts and behaviors in the maintenance of depressed mood. CBT also includes mood and activity monitoring, activity scheduling, and teaching participants to critically investigate and challenge negative thoughts and core beliefs that help to maintain depression.
16307203|NCT00595374|Drug|insulin detemir|
16307204|NCT00595374|Drug|insulin NPH|
16307205|NCT00595374|Drug|insulin aspart|
16307206|NCT00595361|Drug|salmeterol|salmeterol 50 micrograms twice daily for 2 weeks
16307207|NCT00595335|Drug|Rituximab|Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
16307208|NCT00595335|Drug|Saline|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
16307209|NCT00595335|Drug|Methylprednisolone|Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.
16307210|NCT00595322|Other|bevacizumab and radiation (IMRT)|bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)
16307211|NCT00595309|Biological|IC51|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization
16307212|NCT00595296|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).
16307213|NCT00595283|Behavioral|Parent Child Interaction Therapy-Emotion Development (PCIT-ED)|PCIT-ED includes fourteen 1-hour therapy sessions over 14 weeks. Sessions will focus on positive parent-child interactions skills, ways to manage emotions, and relaxation techniques.
16307214|NCT00595283|Behavioral|Developmental Education Parenting Intervention (DEPI)|DEPI includes 14 weekly, 1-hour education sessions covering a range of child development and parenting topics. Classes are in a small group format and will emphasize emotional and social development.
16307215|NCT00595270|Biological|IC51|
16307216|NCT00595257|Device|centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)|autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
16307217|NCT00595244|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
16307218|NCT00595231|Drug|SYN111|500 mg for 1 week followed by 1000 mg for 7 weeks
16307219|NCT00595231|Drug|Placebo|0 mg tablets
16307220|NCT00595218|Behavioral|Physician behavior related to Patient Preference Survey|Access to initial Patient preference survey results
16307221|NCT00595218|Other|Patient Preference Results|Knowledge of Patient Preference Results
16307222|NCT00595205|Other|Hospital log review.|Reviewing of the hospital log to monitor for the occurrence of intussusception.
16307223|NCT00595166|Device|Vaginal Speculum Sheath|Patients received the sheathed speculum exam: The clinician will begin to place the sheath onto the speculum. The sheath is attached to a thin piece of cardboard. The proximal end of the cardboard is placed between the speculum blades and is pushed toward the speculum handle. The blades of the speculum are simultaneously guided to enter the 2 pockets of the sleeve, like fingers going into a glove. The speculum exam will then be completed according to usual procedures. In the event the sheathed speculum exam is unsatisfactory the clinician will do standard of care (the clinician's usual routine at the bedside).
16307224|NCT00595153|Drug|Pulmicort|inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
16307225|NCT00595140|Drug|pegvisomant|growth hormone receptor antagonist pegvisomant in patients´ individual dose
16307226|NCT00595140|Drug|combination with somatostatin analogue octreotide|s.c., 100µg, one time
16307227|NCT00595140|Drug|combination with dopamine agonist cabergoline|oral, 0.5mg, one time
16307228|NCT00595127|Drug|Cyclophosphamide|Cyclophosphamide (10mg/kg/day x 4days)
16307229|NCT00595127|Drug|Fludarabine|Fludarabine (30mg/m^2/day x 5 days)
16307230|NCT00595127|Radiation|Total body irradiation (TBI)|TBI (450 cGY in a single fraction)
16307231|NCT00595101|Drug|PF-03187207|
16307232|NCT00595101|Drug|Latanoprost 0.005%|
16307233|NCT00595101|Drug|PF-03187207 Vehicle|One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
16307234|NCT00595101|Drug|Latanoprost Vehicle|
16307235|NCT00595088|Biological|BC-819/PEI|Papillary tumors will be resected with the exception of one marker tumor that will remain to examine the effects of the treatment on the remaining tumor. Study treatments will consist of an induction course of six weekly instillations of 20 mg of DTA-H19/PEI into the urinary bladder. Intravesical therapy will be delivered through a Foley catheter. Patients will be instructed to hold the dose in the bladder for two hours after administration. If the patient has a complete response, then she/he will be eligible to receive three additional courses of 3 weekly intravesical administrations of the same dose of investigational product every 12 weeks.
16307236|NCT00595075|Drug|Ramelteon|Ramelteon 8 mg tablet by mouth x 1 dose
16307237|NCT00595075|Drug|placebo|placebo identical in appearance to active experimental drug x 1 dose
16307238|NCT00595062|Radiation|Intra Operative Radiation Therapy (IORT)|Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)
16307239|NCT00595049|Drug|bosentan|Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid
16307309|NCT00594347|Biological|Prevnar|Vaccine (Prevnar)
16307240|NCT00595023|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).
16307241|NCT00595010|Behavioral|SafeCare|Treatment will be based on an updated version of the SafeCare program, which specifically addresses parenting and discipline associated with child physical abuse. Participants will receive services from Comprehensive Home-Based Services.
16307242|NCT00594997|Behavioral|Education|Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
16307243|NCT00594997|Behavioral|Control (pre and post surveys)|Students fill out a pre and post survey and then receive the same intervention given to the controls.
16307244|NCT00594984|Drug|Cetuximab|IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
16307245|NCT00594984|Drug|Irinotecan|IV solution, IV, Q3W, 350 mg/m2, until progression
16307246|NCT00594984|Drug|Brivanib|Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
16307247|NCT00594984|Drug|Brivanib|Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
16307248|NCT00594984|Drug|Brivanib Placebo|Oral, tablet, QD, until progression
16307249|NCT00594971|Other|Organisational intervention|A shared care approach in which extra effort is put into improving the communication between the hospital and the primary sector.
16307250|NCT00594971|Other|Referral to a specialist palliative care team.|Discharge with referral to a specialist palliative care team. This is a patient-centred shared care model in which the palliative team helps to organise the patient's treatment and care.
16307251|NCT00594958|Biological|IC51|6 mcg, intramuscularly [i.m.], 0.5 mL
16307252|NCT00594945|Drug|Clonazepam|1 Dose
16307253|NCT00594932|Drug|mycophenolate mofetil|First treatment month: mycophenolate mofetil ascending doses orally Second treatment month to end of study: mycophenolate mofetil 3 gms/day (or less if tolerance issues arise)
16307254|NCT00594932|Other|placebo|"oral placebo will be given in ascending doses during the first month and at full dose during the second and third month (or at lower dose if tolerance issues warrant). During the fourth month mycophenolate mofetil will be given in ascending doses to 3 gms/day (or less if tolerance issues arise) and continues until the end of the study at 6 months."
16307255|NCT00594906|Drug|Teriparatide|Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
16307256|NCT00594906|Drug|Placebo|Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
16307257|NCT00594893|Procedure|Mini Incision Approach|Mini Incision Approach
16307258|NCT00594893|Procedure|2 Incision Approach|2 Incision Approach
16307259|NCT00594880|Drug|Pegylated Interferon-alpha 2a, 180 mcg/week sc|Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
16307260|NCT00594880|Drug|Pegylated Interferon-alpha 2a, 90 mcg/week sc|Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
16307261|NCT00594867|Drug|Acetaminophen - 4 grams per day + Placebo|Acetaminophen - 4 grams per day + Placebo
16307262|NCT00594867|Drug|Aspirin - 325 mg per day + Placebo|Aspirin - 325 mg per day + Placebo
16307263|NCT00594867|Drug|Acetaminophen 4 gram per day + Aspirin 325 mg per day|Acetaminophen 4 gram per day + Aspirin 325 mg per day
16307264|NCT00594854|Drug|PN400 (VIMOVO)|PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).
16307265|NCT00594854|Drug|Diclofenac/Misoprostol|Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.
16307266|NCT00594841|Procedure|Open Reduction Internal Fixation of AC joint dislocation|"Definitive surgical treatment (i.e., ORIF) will be performed within 28 days of the injury. In all cases the procedure will be performed by an orthopedic staff surgeon with the assistance of a fellow/resident(s). The operating surgeon will determine the positioning of the patient for surgery. ORIF of the AC joint dislocation will be carried out as follows:
~Anatomic reduction of the AC joint
~Definitive fixation with a hook plate and screws"
16307267|NCT00594841|Other|Non operative treatment of AC joint dislocation (sling)|Standard protocol for conservative treatment will consist of the implementation of a sling, for shoulder support and patient comfort, for four weeks followed by physiotherapy. Pendulum exercises may be implemented at any time as dictated by the attending surgeon.
16307268|NCT00594828|Device|CoaguChek (Patient self testing)|Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system
16307269|NCT00594828|Device|Anticoagulation Management Service (AMS)|Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician
16307270|NCT00594815|Drug|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine|Immunochemotherapy
16307271|NCT00594789|Other|Information letters|Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.
16307272|NCT00594776|Device|Cone Beam CT Scan|The Cone Beam Computerized Tomographic (CBCT) device utilizes computerized tomographic technology, a special digital imaging plate and a computer to create a three-dimensional image. The special imaging plate and software allow for small details to be imaged without tissue overlap.
16307273|NCT00594737|Drug|memantine hydrochloride|memantine hydrochloride oral tablets, 10mg po bid
16307310|NCT00594334|Drug|Risedronate|Weekly Risedronate
16307274|NCT00594724|Procedure|MRI|Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
16307275|NCT00594698|Drug|PB127 for injectable suspension|0.175 mg/kg diluted in 150 mL 5% Dextrose for Injection in glass bottles, to be administered as a single continuous infusion during image acquisition. Infusion time not to exceed 60 minutes
16307276|NCT00594659|Behavioral|Psychotherapy|Nine session treatment
16307277|NCT00594659|Behavioral|Computerized Psychotherapy|Nine session computer delivered treatment
16307278|NCT00594659|Behavioral|Motivational enhancement therapy|Two session treatment
16307279|NCT00594646|Drug|TRUVADA + raltegravir|TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
16307280|NCT00594633|Other|donepezil and questionaires|Patients will undergo a brief cognitive evaluation prior to (baseline/Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 2) ,Cognitive Re-Evaluation (about 6 months after discontinuation of Donepezil). Then pt will be tx with donepezil, an acetylcholinesterase inhibitor. They will undergo a four-week dose titration (i.e., 5mg QD during weeks 1-4) to reach a final dose of 10mg QD of oral donepezil there after for a maximum of 24 weeks.
16307281|NCT00594620|Dietary Supplement|Flav-ein capsules|Soy/isoflavone supplementation
16307282|NCT00594620|Drug|Placebo|Placebo
16307283|NCT00594607|Device|AN69ST dialysis membrane|AN69ST is the filter that the blood goes through during hemodialysis
16307284|NCT00594607|Device|Fx8 (Fresenius)|Polysulphone dialysis membrane
16307285|NCT00594594|Other|Probiotic Lactobacillus GR-1 and RC-14|Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months
16307286|NCT00594581|Drug|Juvista (avotermin) plus placebo, standard-care (within-subject controls)|Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
16307287|NCT00594568|Drug|LY450139|Administered orally once daily
16307288|NCT00594568|Drug|Placebo|Administered orally once daily
16307289|NCT00594555|Drug|Imatinib Mesylate|Imatinib Mesylate: 400mg po BID every day. Imatinib Mesylate will be administered Day 2 to Day 15
16307290|NCT00594555|Drug|CLAG|"Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2
~Cytarabine: 2gm/m2 administered through a 4 hour intravenous infusion starting 2 hours after the ignition of Cladribine for 5 days starting on Day 2
~G-CSF: 300mcg sc for 6 days starting at 24 hours (Day 1) before the first dose of Cladribine; administration starting on Day 1 for 6 days"
16307291|NCT00594542|Drug|lidocaine|Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.
16307292|NCT00594529|Procedure|Surgery|Liver resection for metastatic liver lesions
16307293|NCT00594516|Drug|tapentadol (CG5503) Immediate Release IR|21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period
16307294|NCT00594516|Drug|tapentadol (CG5503) Extended Release (ER)|During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second
16307295|NCT00594516|Drug|tapentadol (CG5503) Immediate Release (IR)|Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second
16307296|NCT00594503|Drug|Hyperbaric oxygen therapy|Total body exposure to increased atmospheric pressure oxygen
16307297|NCT00594477|Radiation|IMRT|
16307298|NCT00594464|Drug|Rotigotine|"2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;
~Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;
~One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery."
16307299|NCT00594438|Device|Synthes Reamer-Irrigator-Aspirator (RIA)|A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram (TEE) will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using the RIA device.
16307300|NCT00594438|Device|Zimmer Sentinel Reamer|A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram TEE will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using either a conventional reaming technique or the RIA device.
16307301|NCT00594425|Drug|Methyl aminolevulinate (MAL) PDT|Cream application followed by illumination with red light
16307302|NCT00594412|Procedure|Diagnostic Radiology: 1H-MRS of the liver|
16307303|NCT00594399|Behavioral|Physical Activity Counseling|Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback.
16307304|NCT00594386|Drug|Rotigotine|"Rotigotine transdermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.
~After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours."
16307305|NCT00594373|Drug|Tenofovir gel|1 gm/100 ml of 1% tenofovir gel vaginally daily
16307306|NCT00594373|Drug|Tenofovir gel placebo|1 gm/100 ml of placebo gel vaginally daily
16307307|NCT00594360|Behavioral|Exercise on Prescription|Exercise two times a week for two months at a physiotherapist. Afterwards exercise one time a week at a physiotherapist and self-contained training one time a week for 2 months.
16307308|NCT00594347|Biological|Pneumo 23|Vaccine (Pneumo 23)
16307311|NCT00594321|Device|SPACE CpsXL Bone Cement and SPACE 360 Delivery System|SPACE CpsXL Bone Cement and SPACE 360 Delivery System
16307312|NCT00594321|Device|standard vertebroplasty|standard vertebroplasty
16307313|NCT00594308|Drug|Cyclophosphamide|60mg/kg/day for two consecutive days (-7,-6).
16307314|NCT00594308|Drug|Fludarabine|25mg/m2/day for 5 consecutive days
16307315|NCT00594308|Drug|Cyclosporine|3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
16307316|NCT00594308|Drug|Mycophenolate mofetil|1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
16307317|NCT00594308|Drug|Basiliximab|20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
16307318|NCT00594282|Device|Radiolucent cushion|MammoPad radiolucent breast plate cushion used during mammogram
16307319|NCT00594269|Drug|Risperidone|Discontinuation
16307320|NCT00594269|Drug|Escitalopram|Discontinuation
16307321|NCT00594269|Drug|Citalopram|Discontinuation
16307322|NCT00594269|Drug|Sertraline|Discontinuation
16307323|NCT00594269|Drug|Paroxetine|Discontinuation
16307324|NCT00594256|Drug|Sodium Oxybate|Patients will undergo a one-week evaluation period, which will include a taper and discontinuation of any currently prescribed sedative/hypnotics, as well as baseline diagnostic, psychopathology, neurocognitive and polysomnographic measurements (see below for details). Hypnotic taper may be extended or abbreviated, depending on clinical judgment. Patients will then begin a 4-week trial of adjunctive Xyrem (sodium oxybate). Patients will begin at 4.5 g/night (in divided doses of 2.25 g, with 1st dose at bedtime and then 2nd dose four hours later). Dosage will increase by 1.5 g/day every week, until a dose of 9 g nightly is reached, or a patient cannot tolerate further dose escalations. Medication will be administered in divided dosage for the duration of the study. A three-week taper (by 3 g/day weekly) of sodium oxybate will follow the four-week trial of sodium oxybate.
16307325|NCT00594243|Behavioral|Mindfulness based stress reduction program|8-week mindfulness based stress reduction program
16307326|NCT00594243|Other|Wait-list control|No treatment given.
16307327|NCT00594230|Drug|Panobinostat|Panobinostat(20 mg or 30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
16307328|NCT00594217|Drug|oral micronized progesterone suspension|oral micronized progesterone suspension, single 100 mg oral dose
16307329|NCT00594217|Other|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
16307330|NCT00594204|Drug|varenicline tartrate (CP-526, 555-18)|1 mg twice a day for 12 weeks, starting with a 1-week titration period.
16307331|NCT00594204|Drug|Placebo|matching placebo 1 tablet twice a day for 12 weeks
16307332|NCT00594191|Drug|Simvastatin|20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
16307333|NCT00594191|Drug|Placebo|Placebo with the same characteristics of the drug and at the same dose
16307334|NCT00594178|Device|Motorized bicycle exercise training|Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months
16307335|NCT00594165|Drug|Rotigotine|"Rotigotine trans-dermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~During the first year:
~The maximum Rotigotine dose allowed is 6 mg/24 hours.
~After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours."
16307336|NCT00594152|Drug|CIIIT|The intravenous infusion group received three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to subcutaneous insulin.
16307337|NCT00594139|Biological|Autologous neobladder construct|provision of an autologous neo-bladder construct
16307338|NCT00594126|Drug|Imetelstat Sodium (GRN163L)|25% dose escalation infused over 2 hours weekly
16307339|NCT00594113|Other|Touch 2 Screen|"Multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of implementation intentions, an advanced planning model taken from the Theory of Planned Behavior"
16307340|NCT00594113|Other|Touch screen intervention|Touch screen intervention
16307341|NCT00594100|Device|GORE Flow Reversal System (GFRS)|Carotid artery angioplasty and stenting with embolic protection
16307342|NCT00594087|Drug|eszopiclone|eszopiclone 2mg or 3mg at bedtime
16307343|NCT00594087|Other|placebo|2 mg or 3 mg at bedtime
16307344|NCT00594074|Other|white wine|3.25 ounces of white wine twice a day with lunch and dinner
16307345|NCT00594061|Device|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.
16307346|NCT00594048|Device|Resperate|Use of the device 15 minutes a day for 9 weeks
16307347|NCT00594048|Device|discman with freely chosen music|Use the discman 15 minutes a day for 9 weeks
16307348|NCT00594035|Device|Spinal Sealant System|
16307349|NCT00594035|Device|Standard of care|Standard of care: devices intended to provide a watertight closure
16307350|NCT00594022|Device|"Electric stimulation of the Vestibular Nerve - VirtuSom"|This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes.
16307351|NCT00594022|Device|"Electric stim of the Vestibular Nerve - VirtuSom - SHAM"|This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only.
16307400|NCT00593554|Radiation|Total Body Irradiation|8 Gy on Day -9
16307401|NCT00593554|Drug|Thiotepa|5 mg/kg/d on Day -8 to -7
16307402|NCT00593554|Drug|Fludarabine|40 mg/m2/d on Day -6 to -3
16307352|NCT00594009|Device|Venovenous CO2 Removal (VVCO2R) in COPD|Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
16307353|NCT00593996|Other|Ergocalciferol (vitamin D2)|50,000 IU 3 times weekly for 4 weeks
16307354|NCT00593983|Behavioral|Peer-driven intervention|Consists of four structured intervention sessions lasting 6 hours in total, three peer education/recruitment experiences, and brief liaison contacts by an intervention facilitator during AIDS clinical trial screening
16307355|NCT00593983|Behavioral|Time-matched health education|Health education and standard of care treatment
16307356|NCT00593957|Drug|Dextromethorphan|Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial.
16307357|NCT00593957|Drug|Dextromethorphan|Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.
16307358|NCT00593944|Biological|MDX-1342|MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.
16307359|NCT00593931|Other|fMRI|Functional Magnetic Resonance Imaging without contrast
16307360|NCT00593905|Drug|Sitaxsentan|Sitaxsentan sodium 100 mg tablet every morning
16307361|NCT00593905|Drug|Bosentan, Ambrisentan|Bosentan 125 mg tablet twice daily Ambrisentan 5-10 mg tablet once daily
16307362|NCT00593879|Drug|Mecamylamine|2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
16307363|NCT00593866|Radiation|INTENSITY MODULATED RADIOTHERAPY|Five fractions weekly, fraction size determined by dose level
16307364|NCT00593866|Drug|Gemcitabine|1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
16307365|NCT00593853|Drug|Methylphenidate Hydrochloride|Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
16307366|NCT00593853|Drug|Matched Placebo|Run in period of 5mg QD,PO for 2 weeks followed by 5mg BID,PO for 8 weeks (full daily dose of 10mg). Followed by a 2 week taper period of 5mg QD,PO to complete 12 week cycle.
16307367|NCT00593840|Radiation|Intensity modulated radiation therapy|
16307368|NCT00593827|Drug|Ixabepilone|Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
16307369|NCT00593827|Drug|Ixabepilone|Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
16307370|NCT00593814|Device|GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability|Implant
16307371|NCT00593801|Drug|epoetin beta|250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day
16307372|NCT00593801|Drug|epoetin beta|250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
16307373|NCT00593775|Procedure|assisted hatching|assisted hatching with laser
16307374|NCT00593749|Behavioral|Healthy Corner Store Initiative|modification of snacks and beverages offered in corner store surrounding 10 schools
16307375|NCT00593749|Behavioral|Control|control group in study
16307376|NCT00593736|Drug|Ramelteon|Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.
16307377|NCT00593736|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once daily for up to two weeks.
16307378|NCT00593736|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to two weeks.
16307379|NCT00593736|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.
16307380|NCT00593723|Radiation|IMRT|
16307381|NCT00593710|Drug|Losartan|Losartan (25mg OD)
16307382|NCT00593710|Drug|Atenolol|Atenolol (25-50mg OD)
16307383|NCT00593697|Drug|trastuzumab (9 weeks) + docetaxel|"Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio:
~A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 ->FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)"
16307384|NCT00593697|Drug|trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)|Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
16307385|NCT00593684|Device|Silver Alginate|This is a sterile patch of polyurethane foam coated with silver alginate and maltodextrin matrix that is impregnated with 141 mg of ionic silver per 100 cm2.
16307386|NCT00593671|Procedure|Preimplantation genetic screening after embryo biopsy|Preimplantation genetic screening after embryo biopsy
16307387|NCT00593658|Drug|pentoxifylline|pentoxifylline extended release 800mg PO TID for 8 weeks
16307388|NCT00593645|Drug|Clofarabine|
16307389|NCT00593645|Drug|Cytarabine|
16307390|NCT00593645|Drug|Thymoglobulin|
16307391|NCT00593645|Procedure|Stem cell infusion|
16307392|NCT00593632|Dietary Supplement|Uncle Sam Cereal|two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet
16307393|NCT00593619|Drug|Iron dextran|300mg in 250cc normal saline given over 2 hours
16307394|NCT00593619|Drug|Iron sucrose|300mg in 250cc normal saline given over 2 hours
16307395|NCT00593606|Drug|Rotigotine|Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
16307396|NCT00593580|Drug|placebo|placebo
16307397|NCT00593580|Drug|alendronate/cholecalciferol|FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
16307398|NCT00593567|Drug|gentamicin-collagen sponge|Inserted daily into open ulcer
16307399|NCT00593567|Drug|Levofloxacin|750mg oral levofloxacin daily
16307404|NCT00593554|Drug|Palifermin|60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
16307405|NCT00593528|Device|Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)|Vascular Stents
16307406|NCT00593528|Device|PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)|Vascular Stents
16307407|NCT00593528|Procedure|Transjugular intrahepatic portosystemic shunt (TIPS)|Transjugular intrahepatic portosystemic shunt (TIPS)
16307408|NCT00593515|Behavioral|Family cognitive behavioral therapy|12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
16307409|NCT00593515|Behavioral|Child-focused cognitive behavioral therapy|12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
16307410|NCT00593502|Drug|oseltamivir|Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days
16307411|NCT00593502|Drug|placebo|The dosage of placebo will be similar to the active drug
16307412|NCT00593489|Other|Basal Insulin Initiation Strategy|This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop. Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation. Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose.
16307413|NCT00593476|Other|PCD|pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
16307414|NCT00593476|Other|DSE|12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24
16307415|NCT00593463|Drug|Cycloserine|Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
16307416|NCT00593463|Drug|Diltiazem|Diltiazem: 30, 60, 120 mg oral capsule may possibly be
16307417|NCT00593463|Drug|Gabapentin|Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
16307418|NCT00593463|Drug|Isradipine|Isradipine: 5, 10 mg oral capsule may possibly be given
16307419|NCT00593463|Drug|Naloxone|Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
16307420|NCT00593463|Drug|Nifedipine|Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
16307421|NCT00593463|Drug|Placebo|Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given
16307422|NCT00593463|Device|Saline|Saline: I.M. injection may possibly be given
16307423|NCT00593463|Drug|Verapamil|Verapamil: 30, 60, 120 mg oral capsule may possibly be given
16307424|NCT00593450|Drug|ranibizumab|• 0.5 mg (0.05 mL)intravitreal injection
16307425|NCT00593450|Drug|bevacizumab|• 1.25 mg (0.05 mL)intravitreal injection
16307426|NCT00593424|Other|Low Fat/High Carbohydrate|Low Fat/High Carbohydrate for 6 week period
16307427|NCT00593424|Other|High Monounsaturated Fat/Low Carbohydrate|High Monounsaturated Fat/Low Carbohydrate for 6 week period
16307428|NCT00593385|Device|iCAST covered stent|Iliac stent implantation
16307429|NCT00593372|Behavioral|Spaced Retrieval Training|Increasing time to remember important information.
16307430|NCT00593346|Radiation|brachytherapy|brachytherapy (radioactive implants)
16307431|NCT00593333|Device|Antegrade Intramedullary Nail|Use of an antegrade intramedullary nail implanted through the Piriformis fossa of the femur. The use of these nails has yielded a union rate of 97 - 99%, and has clearly become the most commonly utilized implant for femur fractures.
16307432|NCT00593333|Device|Trigen Trochanteric Femoral Nail|Antegrade intramedullary nails developed with a proximal lateral bend that allows implantation through the greater trochanter rather than the piriformis fossa. This start portal is remarkably easier to locate and may be associated with decreased risk of abductor muscle weakness and pain.
16307433|NCT00593320|Radiation|Stereotactic Radiosurgery|
16307434|NCT00593307|Other|high GI|high GI and high carb breakfast
16307435|NCT00593307|Other|Low GI|low GI, high carb breakfast
16307436|NCT00593307|Other|Low GI Low Carb|low GI low carb breakfast
16307437|NCT00593307|Other|High GI Low carb|high GI low carb breakfast
16307438|NCT00593294|Behavioral|Physical exercise|45 minutes each day for three times/week for 6 months
16307439|NCT00593294|Drug|OC - Drospirenone plus Ethynylestradiol|1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)
16307440|NCT00593294|Dietary Supplement|Vitamin, polyvitamins tablets|Tablet of vitamin 1cp for 21 days each month for 6 months
16307441|NCT00593281|Drug|Hylenex|Add Hylenex to SC injection of Morphine
16307442|NCT00593255|Drug|soluble human insulin|
16307443|NCT00593255|Drug|insulin aspart|
16307444|NCT00593255|Drug|insulin NPH|
16307445|NCT00593242|Biological|infusion of autologous cord blood|infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg
16307446|NCT00593242|Other|Neurodevelopmental outcomes|historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
16307447|NCT00593216|Device|Functional MRI imaging|The functional MRI imaging of whole brain will be obtained before, during and after the vestibular response which is induced by the designated caloric stimulation. Post-imaging analysis will reveal which region or neural pathways in the central nervous system may attributed to the development of vertigo.
16307448|NCT00593190|Drug|Gas SF6 (Sulfur Hexafluoride)|ONCE
16307449|NCT00593177|Drug|PTH (1-34) Gel / Placebo Gel|Topical dosing of gel twice daily for eight weeks.
16307450|NCT00593164|Device|Cooling with ThermoSuit with Magnesium Sulfate Infusion|Cooling with LRS ThermoSuit within 15 minutes of intravenous Magnesium Sulfate infusion (30 mg/kg, added to 100 ml normal NaCl solution, given over 15 min).
16307874|NCT00589472|Drug|Leuprolide Acetate|Given IM
16307451|NCT00593164|Device|Cooling with ThermoSuit with Normal Saline Infusion|Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).
16307452|NCT00593151|Other|Locteron (controlled-release interferon alpha 2b)|biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
16307453|NCT00593151|Biological|pegylated IFNa2b|biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg
16307454|NCT00593138|Drug|dex-methylphenidate|The drug is administered as a capsule by mouth. Participants are assigned to receive either 20, 30 or 40 mg doses before each scan visit.
16307455|NCT00593125|Drug|levetiracetam|The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will not be blind to the subject's medication administration. The medication will be discontinued over a two-week period
16307456|NCT00593112|Drug|OROS methylphenidate|Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.
16307457|NCT00593112|Other|No intervention|No intervention
16307458|NCT00593099|Drug|Bupropion|BUP [as the intermediate-release (IR) formulation] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg [as BUP SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10.
16307459|NCT00593099|Drug|Placebo|matching placebo capsules (PLA) containing only a dextrose matrix.
16307460|NCT00593086|Procedure|Pain management|Pain mamagement for burn care procedures.
16307461|NCT00593086|Other|Standard of care/no virtual reality game|no intervention for standard of care
16307462|NCT00593073|Behavioral|Electronic tailored messaging|Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.
16307463|NCT00593073|Behavioral|General Reminder Message|General CRC health education message and reminder to get screened.
16307464|NCT00593060|Drug|Temsirolimus|Given intravenously every week of each 28-day cycle (days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.
16307465|NCT00593060|Drug|Cetuximab|One dose is given intravenously 7 days prior to the start of each 28-day cycle, then it is given every week (along with temsirolimus)of each 28-day cycle (on days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.
16307466|NCT00593047|Drug|KB2115|tablet formulation given once daily for 12 weeks
16307467|NCT00593008|Drug|Temsirolimus|Given intravenously every week of each 28-day cycle (days 1, 8, 15 and 22). Participants may continue to receive study treatment as long as their tumor is responding and they don't experience any serious side effects.
16307468|NCT00593008|Drug|Gemcitabine|Given intravenously every other week of each 28-day cycle.
16307469|NCT00592995|Drug|Creatine monohydrate|10 to 30 grams daily
16307470|NCT00592995|Drug|Placebo|10 to 30 grams daily
16307471|NCT00592969|Drug|metformin|
16307472|NCT00592969|Drug|biphasic insulin aspart|
16307473|NCT00592943|Drug|armodafinil|tablet, taken by mouth, once each study day
16307474|NCT00592930|Drug|olanzapine|flexibly dosed oral olanzapine 2.5 to 15 mg/day
16307475|NCT00592930|Drug|placebo|
16307476|NCT00592917|Dietary Supplement|calcium carbonate and cholecalciferol|one tablet (calcium carbonate resembling 500 mg of calcium and 400 IU or 5 micrograms of vitamin-D3, cholecalciferol) twice daily for the whole duration of the study
16307477|NCT00592904|Drug|E2007|Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).
16307478|NCT00592891|Drug|Hyperbaric oxygen therapy|Total body pressurized oxygen
16307479|NCT00592852|Drug|fluoxetine|capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
16307480|NCT00592839|Drug|SCE-B|0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
16307481|NCT00592839|Drug|Placebo|Matching placebo for 0.3 mg and 0.625 mg tablets
16307482|NCT00592813|Behavioral|Enhanced Strong for Life|"The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion.
~Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars."
16307483|NCT00592813|Behavioral|cardiovascular nutrition education|administered as an attention control intervention using home visits, phone calls and mail-outs of information
16307484|NCT00592774|Drug|E2007 (perampanel)|2 mg titrated up to 8 mg maximum; taken once daily.
16307485|NCT00592774|Drug|Placebo|2 mg titrated up to 8 mg maximum; taken once daily.
16307486|NCT00592761|Behavioral|Mendelsohn Maneuver|Mendelsohn Maneuver with Surface Electromyography
16307487|NCT00592748|Radiation|Charged Particle Radiation Therapy|Radiation doses will be determined by planning CT
16307488|NCT00592735|Procedure|laparoscopic gastric banding|standard surgical procedure
16307489|NCT00592683|Drug|Aripiprazole|tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks
16307490|NCT00592683|Dietary Supplement|fish oil|1600mg (4 capsules) daily for 12 weeks
16307491|NCT00592683|Drug|Placebo|Placebo
16307492|NCT00592670|Drug|Fluoxetine|20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment
16307665|NCT00591123|Drug|5-FU|5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
16307493|NCT00592670|Drug|Placebo|20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.
16307494|NCT00592644|Procedure|Pulse Dye laser (PDL)|one-time PDL, in 10 subjects
16307495|NCT00592644|Procedure|CO2 laser or other traditional surgeries|once-time CO2 laser or other conventional surgeries, in other 10 subjects
16307496|NCT00592631|Device|CPAP-Continuous Positive Airway Pressure|Cpap will be worn at night by subjects 6 to 7 days duration.
16307497|NCT00592631|Device|SHAM|SHAM will be worn at night by subjects 6 to 7 days duration.
16307498|NCT00592618|Drug|Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeks|
16307499|NCT00592592|Radiation|Proton Beam Radiation|Once per day, 5 days a week for a total of 4 to 6 weeks.
16307500|NCT00592579|Drug|2-methoxyestradiol|800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
16307501|NCT00592566|Drug|Dexamethasone, desmopressin|200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion
16307502|NCT00592553|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the respective arms.
16307503|NCT00592553|Drug|Placebo|Placebo matching to ataluren will be administered as the schedule specified in the respective arm.
16307504|NCT00592540|Procedure|Unrelated Donor BMT|Unrelated donor bone marrow transplantation has not been performed with these patients in the past
16307505|NCT00592527|Drug|insulin detemir|
16307509|NCT00592488|Drug|Acetyl-L-Carnitine|Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
16307510|NCT00592475|Drug|conivaptan|IV
16307511|NCT00592475|Drug|Placebo|IV
16307512|NCT00592462|Procedure|Whole Body MRI|The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.
16307513|NCT00592449|Behavioral|Cognitive behavioral therapy (CBT) for insomnia|During CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist.
16307514|NCT00592449|Behavioral|Behavioral desensitization treatment for insomnia|The behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist.
16307515|NCT00592423|Other|Continuous Positive Airway Pressure during MRI|10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes.
16307516|NCT00592410|Drug|human regular insulin|administration of a primed continuous infusion of human regular insulin at a rate of 2.0 mU/kg/min while maintaining the plasma glucose level at 100 mg/dl via adjusting a variable infusion of 50% dextrose (i.e., a hyperinsulinemic euglycemic blood glucose clamp); duration of 3 hours; performed concomitantly with amino acid supplementation
16307517|NCT00592397|Other|Balanced macronutrient diet intervention|Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
16307518|NCT00592384|Drug|venlafaxine XR|Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg
16307519|NCT00592384|Drug|placebo|Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg
16307520|NCT00592358|Drug|paliperidone|tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks
16307521|NCT00592345|Radiation|Proton Beam Radiation|Administered over a period of 12 weeks.
16307522|NCT00592345|Radiation|Photon Beam Radiation|Administered over a period of 12 weeks.
16307523|NCT00592345|Radiation|Interoperative radiation|Radioactive plaque applied at the time of surgical removal of the tumor.
16307524|NCT00592332|Drug|Alprazolam|1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
16307525|NCT00592332|Other|control group|control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.
16307526|NCT00592319|Drug|Celebrex|oral taking of Celebrex (100 mg, BID) for 9 months
16307527|NCT00592319|Device|PDL|once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
16307528|NCT00592319|Procedure|CO2 laser or microsurgery|once-time surgery to remove laryngeal papilloma
16307529|NCT00592306|Drug|thymoglobulin (intraoperative)|"All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered.
~Each arm will also receive a single placebo dose.
~Arm I will receive thymoglobulin intraoperatively followed by a postoperative placebo dose and two subsequent thymoglobulin doses."
16307530|NCT00592306|Drug|thymoglobulin (postoperative)|"All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered.
~Each arm will also receive a single placebo dose.
~Arm II will receive placebo intraoperatively followed by 3 postoperative doses of thymoglobulin."
16307531|NCT00592293|Radiation|Proton Beam Radiation|Once per day, 5 days a week for a total of 4 to 6 weeks.
16307532|NCT00592280|Device|Two-Layer Method pancreas preservation system|Preserving the pancreas before transplantation in an oxygenated system containing highly oxygenated liquid perfluorocarbon (perfluorodecalin, C10F18. The perfluorocarbon combines low toxicity with a capacity to dissolve 75 times more oxygen than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury.
16307533|NCT00592241|Device|"Adi Insulin Pump Usability"|no intervention
16307534|NCT00592228|Device|Cypher, Taxus or Endeavor|"percutaneous drug-eluting stent implantation,
~FFR group: if FFR<0.75
~Routine DES group"
16307535|NCT00592215|Drug|Experimental (mifepristone and misoprostol)|Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
16307875|NCT00589472|Procedure|Therapeutic Conventional Surgery|Undergo radical prostatectomy
16307536|NCT00592202|Device|Placement of an adjustable gastric band|Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
16307537|NCT00592189|Procedure|blood draw|blood collection
16307538|NCT00592176|Drug|local injection of bevacizumab|Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.
16307539|NCT00592163|Drug|ZIO-101-C (Darinaparsin)|Dose Escalation study, 200 mg - 900 mg, cumulative daily dose split to be taken BID 7 times a week (>8 hours between doses) for 3 weeks followed by 1 week of rest
16307540|NCT00592150|Drug|fenoldopam|The fenoldopam infusion rate will be 0.05 μg/kg/min for 3 hours
16307541|NCT00592150|Drug|Placebo|Placebo infusion for 3 hours
16307542|NCT00592137|Dietary Supplement|C (smoothies based on soy protein containing no additional calcium)|Two smoothies per day based on soy protein containing no additional calcium
16307543|NCT00592137|Dietary Supplement|B (smoothies based on soy protein containing calcium)|Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
16307544|NCT00592137|Dietary Supplement|A (smoothies based on dairy protein containing calcium)|Two smoothies daily based on dairy protein containing 650 mg calcium
16307547|NCT00592111|Drug|COPP/ABV|4 courses of COPP/ABV hybrid
16307548|NCT00592111|Drug|COPP/ABV|6 courses of COPP/ABV hybrid
16307549|NCT00592111|Drug|intensive chemo with concurrent growth factor|6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
16307550|NCT00592098|Drug|Strontium chloride hexahydrate|Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
16307551|NCT00592098|Drug|Placebo|Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
16307552|NCT00592085|Behavioral|Questionnaires|Participants will use a computer to complete a series of questionnaires.
16307553|NCT00592085|Behavioral|Motivational Relapse Prevention Counseling|Total of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
16307554|NCT00592085|Behavioral|Relapse Plus Alcohol Risk Reduction Counseling|Total of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
16307555|NCT00592072|Dietary Supplement|Medium chain fatty acid (Octanoic and Decanoic acid)|Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
16307556|NCT00592072|Other|Splenda (Placebo Control)|Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.
16307557|NCT00592046|Drug|ZIO-101 (Darinaparsin)|ZIO-101 (Darinaparsin) given for five consecutive days to be repeated every 28 days for up to six months. This is a dose escalation study.
16307558|NCT00592033|Other|oxygen from a portable concentrator|2 l/minute during exercise
16307559|NCT00592020|Procedure|Short Transverse Incision|Short Transverse Incision for kidney transplantation
16307560|NCT00592020|Procedure|Hockey Stick Incision|Hockey Stick Incision for kidney transplantation
16307561|NCT00592007|Drug|Fulvestrant and Erlotinib|Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.
16307562|NCT00591994|Drug|piribedil|50 mg once a day, after lunch 3 month therapy
16307563|NCT00591981|Behavioral|TOGA Tools|ADL's, Zubrod, IADL's, BFI, MMS, MNS, GDS
16307564|NCT00591968|Device|SonoSite Titan portable ultrasound coupled with email telediagnosis|"Sonographic exam will be performed by principal investigator. A first-look diagnosis, correlated with patient symptomology and laboratory analysis, will be made at the point of care. Using a store-and-forward framework, properly formatted non-compressed sonographic images and Request for Interpretation (RFI) forms will be transmitted to participating radiologists. RFI forms will be used to record diagnostic findings and rate the quality of the images and/or diagnostic value using a five-point Likert scale. RFI forms will also include a five-digit patient number, age, sex, and symptomology / reason for sonographic exam. Completed RFI forms will be transmitted back to the clinic at the radiologist's earliest convenience."
16307565|NCT00591942|Device|Full ceramic crowns or 3-unit fixed partial dentures.|Subjects who met the inclusion/excluson criteria received two ceramic crowns or one three-unit dental bridge on posterior teeth. The crowns and dental bridge were cemented using two different dental adhesives. Follow-up to assess sensitivity of the crowns/bridges occur at 24 hrs. and 1 week post seating by telephone. Clinical visits to assess sensitivity and the integrity of the crowns/bridges occur at 6, 12, 18 and 24 months post seating of the restorations.
16307566|NCT00591929|Other|Continuous Passive Motion|at least 48 hours of continuous passive motion following ORIF of fractures around the knee
16307567|NCT00591916|Drug|Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]|Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).
16307568|NCT00591916|Procedure|Blood sample|Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
16307569|NCT00591916|Procedure|Biopsy|Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.
16307570|NCT00591890|Drug|indibulin|dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.
16307876|NCT00589472|Drug|Vorinostat|Given PO
16307571|NCT00591877|Procedure|Acupuncture|"Each patient will undergo a 30 minute session, twice a week, for a total of 12 sessions. The technique will involve electro-stimulation at predefined points followed by needle manipulation.
~The acupoints that will be used are:
~ST-36: 3 finger breadths inferior to lower edge of patella between tibialis anterior muscle and the tibia, 1 finger breadth lateral to the anterior crest of the tibia.
~PC-6: 2 finger breadths proximal to and in the middle of the most distal transverse crease of the wrist, between the tendons of palmaris longus and flexor carpi radialis.
~CV-12: 4 finger breadths superior to the umbilicus."
16307572|NCT00591877|Procedure|Sham Acupuncture|"The acupoints for SAC are:
~LI-4 : adjacent to and at the middle of the radial side of the 2nd metacarpal bone, at the same level as the end of the crease when the thumb and index fingers approximate.
~GB-32: on the lateral aspect of the thigh 5 finger breadths proximal to the popliteal crease, 2 finger breadths inferior to GB31.
~UB -15: 1.5 finger breadths lateral to the midline of the spine on a level between the 5 th and the 6 th thoracic vertebrae."
16307573|NCT00591877|Other|Yoga|The participants in this arm will undergo a 60 min session of yoga exercises. These exercises are specifically designed for reflux symptoms by a yoga instructor. This includes a set of specific physical postures (asana) and breathing techniques within the four-element setup. The set of asana are divided into (a) standing, (b) sitting, and (c) lying down positions. The session will begin with asana in standing position, followed by a position called Shavasan (relaxation), then asana in sitting down position followed by Shavasan, finally asana in lying down position followed by Shavasan. At the end of all asana, Pranayam (special breathing exercises) will be practiced.
16307574|NCT00591864|Device|Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
16307575|NCT00591851|Drug|AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)|No Intervention
16307576|NCT00591838|Radiation|Stereotactic Body Radiation Therapy (SBRT)|
16307577|NCT00591825|Drug|D-cycloserine|D-cycloserine
16307578|NCT00591825|Drug|Placebo|Placebo
16307579|NCT00591812|Device|ComPreSs Distal Femoral Replacement System.|ComPreSs system of intramedullary fixation along with the Finn Knee system
16307580|NCT00591799|Device|The Jarvik 2000 Ventricular Assist System|Jarvik 2000 Heart implantation is intended for patient's with end-stage heart failure who are approved heart transplant candidates - who meet all of the study's inclusion criteria and none of its exclusion criteria.
16307581|NCT00591786|Drug|Sugammadex|After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.
16307582|NCT00591773|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 40 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily; and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
16307583|NCT00591773|Drug|Azilsartan medoxomil and chlorthalidone|Azilsartan medoxomil 80 mg, tablets, orally, once daily; azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
16307584|NCT00591773|Drug|Chlorthalidone|Chlorthalidone 25 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily and azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.
16307585|NCT00591760|Drug|Somatotropin|Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
16307586|NCT00591747|Behavioral|Resistance Exercise|60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months
16307587|NCT00591747|Behavioral|Flexibility Training|60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
16307588|NCT00591734|Drug|Bevacizumab|15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
16307589|NCT00591734|Drug|Everolimus|10 mg by mouth daily
16307590|NCT00591721|Behavioral|Energy conservation education|The intervention for this study is a group-based educational program delivered by teleconference to 4-6 individuals with MS by a licensed occupational therapist. The program involves 6 weekly sessions. Each session is 1 hour and 15 minutes in duration. Key topics addressed include: importance of rest, positive and effective communication, modification of the environment, using equipment and technology, setting priorities, and activity analysis and modification. Direct instruction, group discussion, and peer support are key elements of the program. Participants receive a manual with application activities that are completed in between sessions.
16307591|NCT00591708|Dietary Supplement|Beverage containing calcium citrate malate|Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
16307592|NCT00591708|Dietary Supplement|Beverage fortified with calcium citrate malate|Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
16307593|NCT00591695|Procedure|Stent bridge to surgery + elective surgery|positioning in emergency of a metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
16307594|NCT00591695|Procedure|Emergency Surgery|Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
16307624|NCT00591435|Other|Comparison of performance of consultants versus residents|Anesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents
16307595|NCT00591682|Drug|MSX-122|"Dosage form = capsule
~Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.)
~If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort.
~If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort.
~If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort."
16307596|NCT00591669|Other|Definity|We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.
16307597|NCT00591669|Other|Definity|We will be placing one vial (1.3) of Definity® in 50 mL of preservative-free saline. Our infusions will be initiated at slightly lower than recommended starting rate (3mL/min) and will be adjusted as necessary to produce optimal enhancement. The rate will not exceed 10 ml/min and we will not give more than 1.3 mL of Definity® in 50mL saline in any 24-hour period.
16307598|NCT00591643|Procedure|Imaging, Adrenal acans|The patient will be given 5 drops of saturated solution of potassium iodide daily for 2 days prior to the study and will continue for 5 to 7 days later to minimize the radiation dose to the thyroid gland. One to 2 mCi of I 131 1,6-beta-iodomethyl-19-norcholesterol (NP-59) in 10% ethanol, 0.23% polysorbate 80 and 0.9% NaCl will be given intravenously slowly over 1-5 minutes. Anterior and posterior images of the adrenal area will be obtained 72 and 96 hours later. Additional images will be made if indicated. Each image would require 30 minutes carried out in the nuclear medicine laboratory. To verify the exact location of the adrenal glands, renal scan with 99m Tc DTPA or Mag 3 (routine nuclear medicine radiopharmaceuticals) will also be obtained whenever indicated. In some patients, dexamethasone suppression will be carried out to improve the specificity of NP 59 diagnosis for autonomous hormonal secretions by the adrenal tumors.
16307599|NCT00591643|Radiation|(NP-59)|One to 2 mCi of I 131 1,6-beta-iodomethyl-19-norcholesterol (NP-59) in 10% ethanol, 0.23% polysorbate 80 and 0.9% NaCl will be given intravenously slowly over 1-5 minutes.
16307600|NCT00591630|Drug|Zevalin|(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
16307601|NCT00591630|Drug|Carmustine|300 mg/m^2 by vein.
16307602|NCT00591630|Drug|Etoposide|200 mg/m^2 by vein every 12 hours.
16307603|NCT00591630|Drug|Cytarabine|200 mg/m^2 by vein every 12 hours.
16307604|NCT00591630|Drug|Melphalan|140 mg/m^2 by vein.
16307605|NCT00591630|Drug|Rituximab|"Arm 1, Arm 2 = 250 mg/m^2 by vein;
~Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant;
~Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy."
16307606|NCT00591630|Procedure|Stem Cell Transplant|Injection of stem cells (Autologous SCT)
16307607|NCT00591617|Other|Psychosocial treatment plus Suboxone pharmacotherapy|Participants randomly assigned to one of four psychosocial treatment conditions building on pharmacotherapy with Suboxone (buprenorphine + naloxone)
16307608|NCT00591604|Drug|Vitamin D|Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks
16307609|NCT00591591|Device|OxiplexTS|OxiplexTS is a Frequency Domain Near-Infrared Tissue oximeter which provides absolute values of tissue oxygenation in real time. It also provides physiological quantities of oxy, deoxy and total hemoglobin concentration, which form the basis for the functional measurement of brain hemodynamics. Both the control and OSA groups will undergo standard overnight sleep study (PSG). In addition to the standard PSG, with or without Continuous Positive Airway Pressure (CPAP), we will add the OxiplexTS, allowing us to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to the OSA sufferers. Participants with OSA who undergo PSG/CPAP will be also tested with the OxiplexTS. Their PSGs and PSG/CPAP data will be compared.
16307610|NCT00591578|Drug|Azilsartan Medoxomil|Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
16307611|NCT00591578|Drug|Azilsartan Medoxomil|Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
16307612|NCT00591578|Drug|Valsartan|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
16307613|NCT00591565|Drug|Acamprosate|acamprosate 333mg tab, 3 by mouth 3 times a day
16307614|NCT00591552|Device|Harmonic ACE23P Scalpel|Lymph node dissection
16307615|NCT00591552|Device|Electrocautery|
16307616|NCT00591539|Procedure|Carotid Ultrasound|Bilateral carotid ultrasound measurements: A test that uses sound waves to look at the blood vessels in the neck.
16307617|NCT00591526|Drug|Arac|Ommit ARAC in the chemotherapy
16307618|NCT00591500|Behavioral|Questionnaire|Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs
16307619|NCT00591500|Behavioral|Questionnaire|Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs.
16307620|NCT00591487|Drug|Lidocaine|Subcutaneous infiltration with Active/Placebo solutions with tumescent technique previous to suction assisted lipectomy. Patient abdomen and back will be divided in 4 zones anterior and posterior, one side (left or right) will be infiltrated with active solution and the other with placebo. The allocation of the side will be made with random numbers.
16307621|NCT00591474|Dietary Supplement|probiotics|100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
16307622|NCT00591474|Dietary Supplement|yogurt|100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks
16307623|NCT00591448|Other|Virtual Reality (VR)|See above
16309090|NCT00578734|Other|Sham Comparator|Slow intra-tracheal instillation
16307625|NCT00591422|Drug|ZIO-101-C (Darinaparsin)|Capsule, Dose escalation study from 100 mg to 1000 mg (or Maximum Tolerated Dose). 3 times weekly (>36 hours between doses) for 3 weeks with 1 week rest.
16307626|NCT00591409|Drug|sugammadex|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered."
16307627|NCT00591409|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of placebo IV was administered"
16307628|NCT00591396|Drug|ZIO-101 (Darinaparsin)|Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
16307629|NCT00591383|Drug|indibulin|indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
16307630|NCT00591383|Drug|erlotinib|erlotinib taken at 150 mg every morning with food.
16307631|NCT00591370|Drug|Temozolomide (TMZ)|One group treatment study
16307632|NCT00591357|Drug|loperamide|4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
16307633|NCT00591357|Drug|placebo|4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
16307634|NCT00591344|Behavioral|Progressive resistance training|Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.
16307635|NCT00591344|Behavioral|Modified Fitness Counts|The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.
16307636|NCT00591331|Drug|Spinosad (the active ingredient in NatrOVA)|This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
16307637|NCT00591331|Drug|placebo|
16307638|NCT00591318|Drug|ceftriaxone|2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses
16307639|NCT00591318|Drug|Normal Saline|50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions.
16307640|NCT00591305|Dietary Supplement|diindolylmethane (DIM)|3-month DIM
16307641|NCT00591305|Device|585 nm pulsed dye laser|once-time PDL
16307642|NCT00591292|Drug|indibulin|Dose escalation of indibulin given twice daily for up to 6 months
16307643|NCT00591266|Drug|Azilsartan Medoxomil and amlodipine|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
16307644|NCT00591266|Drug|Azilsartan Medoxomil and amlodipine|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
16307645|NCT00591266|Drug|Amlodipine|Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
16307646|NCT00591253|Drug|Azilsartan medoxomil|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
16307647|NCT00591253|Drug|Azilsartan medoxomil|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
16307648|NCT00591253|Drug|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
16307649|NCT00591227|Drug|insulins aspart and detemir|insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
16307650|NCT00591214|Drug|MP-424 (Telaprevir)|Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)
16307651|NCT00591201|Drug|infliximab|Infliximab 5mg/kg diluted in 250 ml of isotonic solution of sodium chloride will be administered by the intravenous route on weeks 0, 2, 6, 12, 18, 24, 30, 36, 42, and 48.
16307652|NCT00591201|Drug|Placebo|Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.
16307653|NCT00591188|Drug|capecitabine, interferon-alpha|Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
16307654|NCT00591175|Behavioral|Standard Care only|Dentist Provided Standard Care, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test
16307655|NCT00591175|Behavioral|Dental Hygienist provided counseling + Brief Questionnaire|Dental Hygienist provided + Brief Questionnaire, 3-month follow-up assessment,Clinic visit salivary cotinine test, 12-month follow-up, Clinic visit salivary cotinine test assessment
16307656|NCT00591175|Behavioral|Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire|Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test
16307657|NCT00591162|Drug|Tetracycline|Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
16307658|NCT00591162|Radiation|Duel Energy X-Ray Absorptiometry (DEXA)|DEXA before discharge from acute admission and again one year post burn.
16307659|NCT00591162|Procedure|Bone Biopsy|Bone biopsy to be taken in the operation room at the last skin grafting operation at the site of the iliac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.
16307660|NCT00591149|Drug|Oxaliplatin|130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
16307661|NCT00591149|Drug|Docetaxel|60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
16307662|NCT00591149|Drug|Cetuximab|400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
16307663|NCT00591136|Drug|indibulin|Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months
16307664|NCT00591123|Drug|FOLFOX|Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions
16307666|NCT00591123|Drug|Erlotinib|All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
16307667|NCT00591110|Behavioral|Eye care education|Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population
16307668|NCT00591110|Behavioral|Social-contact control|Participants receive an engaging informational session on a non-health related topic
16307669|NCT00591084|Drug|ginsenoside-Rd 10 mg|infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
16307670|NCT00591084|Drug|placebo|infusion placebo (group B)once a day and continued for 14 days
16307671|NCT00591084|Drug|ginsenoside-Rd 20mg|infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
16307672|NCT00591071|Other|Strict glycemic control|Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L
16307673|NCT00591071|Other|Conventional glycemic control|Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L
16307674|NCT00591058|Drug|TM-601|TM-601, administered intravenously (IV), once/week for 3 weeks
16307675|NCT00591045|Drug|mFOLFOX|oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
16307676|NCT00591019|Drug|Modafinil|200 mg/day, morning dose
16307677|NCT00591019|Other|Placebo|Sugar pill once per day in the morning.
16307678|NCT00591006|Drug|Phenytoin (brand name Dilantin)|Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total).
16307679|NCT00591006|Drug|Hydrocortisone|Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The doses were selected to achieve a low therapeutic blood level of phenytoin and stress level of cortisol. Newcomer et al. (1999) used this dose of hydrocortisone in healthy controls. The imaging will be performed at approximately 1300 hours.
16307680|NCT00591006|Drug|Placebo|Participants take two capsules of placebo 100 mg at 0900 hours and 2100 hours for a total of 3 days with the last dose at 0900 hours on the day of imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating placebo), participants will being taking 4 tablets containing placebo (20 mg) also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total).
16307681|NCT00590993|Other|MRI and MRSI|Compare treatment impact when using MRI and MRSI
16307682|NCT00590967|Radiation|IMRT extended field external beam radiation therapy|
16307683|NCT00590967|Radiation|Brachytherapy|
16307684|NCT00590967|Drug|Cisplatin|
16307685|NCT00590954|Drug|Perifosine|"Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
~In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4."
16307686|NCT00590941|Procedure|Blood draw|Sample Collection for Genotyping prior to cycle 1 treatment of R-CHOP, if patient is enrolled after cycle 1, sample for genotyping should be collected prior to cycle 2.
16307687|NCT00590928|Drug|esomeprazole|40mg once daily
16307688|NCT00590928|Drug|ranitidine|50mg every h hours
16307689|NCT00590915|Drug|Erwinia L-asparaginase|"Substitute Erwinia L-asparaginase 25,000 international units per meters squared, IM every other day (including weekends and holidays) x 6 doses for each dose of PEG-asparaginase that is replaced.
~NOTE: Erwinia L-asparaginase dosing to replace native E.coli L-asparaginase varies; consult protocol for specifics."
16307690|NCT00590902|Drug|OSI-774: erlotinib, TarcevaTM|150 mg, 100 mg and 25 mg tablets
16307691|NCT00590889|Device|Artificial Mechanical Heart Valve|Both arms used market released mechanical heart valves in accordance with approved labeling
16307692|NCT00590863|Drug|SSRI + placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
16307693|NCT00590863|Drug|Escitalopram + Bupropion SR|Participant will take Burpopion SR (150 to 450 mg/day) + Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
16307694|NCT00590863|Drug|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
16307695|NCT00590850|Device|ORIF with Plate and Screws|ORIF with plate and screws
16307696|NCT00590850|Device|Pin Fixation|Clavicle fixation with clavicle pin
16307697|NCT00590837|Drug|Lomustine|"Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1.
~Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1.
~Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1."
16307698|NCT00590824|Drug|hu14.18-IL2|6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course followed by surgery and up to 2 additional courses of hu14.18-IL2
16307699|NCT00590824|Drug|hu14.18-IL2|Surgery followed by 3 courses of 6 mg/m2 hu14.18-IL2 administered via IV on days 1, 2, and 3 of a 28-day course
16307700|NCT00590798|Behavioral|Walking|Patient will walk within 30 minutes of vascular closure system procedure
16307701|NCT00590785|Drug|Doxorubicin|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
16307877|NCT00589446|Device|Hysteroscope|An 8mm hysteroscope with irrigation channel and 30 degree view will be inserted into the uterus prior to curettage in cases of recurrent missed abortion
16307702|NCT00590785|Drug|Cyclophosphamide|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
16307703|NCT00590785|Drug|G-CSF|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
16307704|NCT00590785|Drug|tamoxifen|High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
16307705|NCT00590785|Drug|ciprofloxacin|High-dose sequential doxorubicin x 4 given with G-CSF on Days 3 - 12+ and followed by high-dose cyclophosphamide x 3 (A+C) given with G-CSF and ciprofloxacin on Days 3-12, followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamxifen 20 mg daily for 5 years.
16307706|NCT00590772|Drug|montelukast|10 mg po each day (compared to placebo for 2 weeks)
16307707|NCT00590772|Drug|placebo|placebo for 2 weeks
16307708|NCT00590759|Device|GORE TAG® Thoracic Endoprosthesis|implant
16307709|NCT00590720|Biological|MEDI528 50 mg|MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
16307710|NCT00590720|Other|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
16307711|NCT00590707|Device|Deeper sedation|The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
16307712|NCT00590707|Device|Moderate sedation|The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
16307713|NCT00590694|Drug|ranibizumab|0.5mg injection monthly according to protocol for one year
16307714|NCT00590681|Drug|Bevacizumab and Temozolomide|This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).
16307715|NCT00590668|Diagnostic Test|Transesophageal Echocardiography|Measurement of peak diastolic flow velocity
16307716|NCT00590655|Behavioral|weight loss programme with maintenance programme|After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
16307717|NCT00590655|Behavioral|weight loss programme|
16307718|NCT00590629|Drug|Niaspan|1500 mg Niaspan for 16 weeks
16307719|NCT00590616|Procedure|transthoracic examination|observational transthoracic examination
16307720|NCT00590603|Drug|Arsenic Trioxide, Ascorbic Acid and Bortezomib|"Phase I/Cohort I
~Loading:
~Arsenic Trioxide (ATO): 0.25 mg/kg IV over 1-2 hr qd x 5 days (Monday-Friday)
~Ascorbic Acid: 1000 mg by IV infusion over 15 minutes after each infusion of arsenic trioxide qd x 5 days
~Maintenance cycles (21 days)
~ATO: 0.25 mg/kg IV over 1-2 hr once a week x 2 weeks every 3 weeks (one cycle) for a total of 6 cycles.
~Ascorbic Acid 1000mg IV will be given within 30 minutes of completion of ATO.
~Bortezomib 1 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 8 of a 21-day cycle. ATO is given at least one hour prior to Bortezomib. The first cycle will start on week 2, after loading dose week.
~Phase I/Cohort 1 is followed by Cohort 2. Phase II uses maximum tolerated dose from Phase I."
16307721|NCT00590590|Drug|Lidocaine/Diphenhydramine|semi solid, twice weekly, 4 months
16307722|NCT00590590|Drug|lidocaine|semi solid, twice weekly for 4 months
16307723|NCT00590590|Drug|placebo|semi solid, twice weekly for 4 months
16307724|NCT00590577|Drug|Paliperidone palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64
16307725|NCT00590577|Drug|Paliperidone palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64
16307726|NCT00590577|Drug|Placebo|Placebo i.m. Days 1, 8, 36, 64
16307727|NCT00590577|Drug|Paliperidone palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64
16307728|NCT00590564|Drug|Sho-saiko-to|All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, and assessed for compliance and asked about side effects and pulmonary symptoms. At each clinic visit, a comprehensive metabolic profile will be performed. At the 6-month clinic visit, a CBC will be performed. At the 12-month clinic visit, quantitative HCV-RNA by PCR will be obtained (Viromed Labs, Inc., 6101 Blue Circle Drive, Minneapolis, MN 5534). Within 4 weeks after the 12-month clinic visit (after 52 weeks of SST therapy), the second liver biopsy will be scheduled and performed.
16307729|NCT00590551|Other|sling or no sling|Groups will be assigned as follows: 1-supine and with sling, 2-30o HOB elevation without leg elevation and with sling, 3-30o HOB elevation with 10o leg elevation and with sling, 4-supine and without sling, 5-30o HOB elevation without leg elevation and without sling, and 6-30o HOB elevation with 10o leg elevation and without sling
16307730|NCT00590538|Drug|Sodium 4-Phenylbutyrate|The standard oral adult dose is 20 g/day (tablets) for 4 days.
16307731|NCT00590538|Drug|Genistein (Unconjugated Isoflavones 100)|Every participant will be administered a perfusion of 50 MicroM of Genistein (Unconjugated Isoflavones 100) during the modified NPD procedure.
16307732|NCT00590538|Drug|Placebo|The placebo is given to match the active comparator for four days.
16307733|NCT00590525|Procedure|Cardioversion|Baseline hsCRP will be drawn the morning of, prior to, cardioversion. An EKG to document the patient's rhythm will be obtained at the one-month mark
16307734|NCT00590512|Dietary Supplement|High sodium|
16307735|NCT00590512|Dietary Supplement|Low sodium|
16307736|NCT00590473|Device|Interstim|Unilateral vs. Bilateral Placement of Interstim IPG
16307737|NCT00590460|Biological|CAMPATH-1H|Given intravenous on days -8, -7, and -6
16307738|NCT00590460|Biological|Anti-CD45|"Given intravenous on days -5, -4, -3 and -2
~dose is 400 micrograms/kg"
16307739|NCT00590460|Drug|Fludarabine|"Given intravenous on days -8, -7, -6, -5 and -4
~Dose is 30 mg/m2"
16307740|NCT00590460|Procedure|Stem cell infusion|Stem cells are infused on day 0
16307741|NCT00590447|Drug|rituximab monotherapy|375 mg/m2, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between course 4 and 5 the patients directly enter R-CHOP chemotherapy (Arm B).
16307742|NCT00590447|Drug|sequential R-CHOP|"375 mg/m2 rituximab, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. Cyclophosphamid 750 mg/m2, adriamycine 50 mg/m2 and vincristine 1.4mg/m2, IV and prednisone 50mg/m2, PO every 3 weeks at days 50, 72, 94 and 116.
~In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between antibody and R-CHOP administration the patients directly enter R-CHOP chemotherapy."
16307743|NCT00590408|Dietary Supplement|coenzyme Q10|60mg capsule twice daily for 12 weeks
16307744|NCT00590408|Dietary Supplement|matching placebo|matching placebo capsule twice daily for 12 weeks
16307745|NCT00590395|Drug|18FDG (an FDA-approved radiopharmaceutical)|Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
16307746|NCT00590382|Device|AMPLATZER Muscular VSD Occluder|AMPLATZER Muscular VSD Occluder
16307747|NCT00590369|Device|KCI -VAC|Negative pressure wound therapy device
16307748|NCT00590369|Device|Versatile One (EZCare)|Negative pressure wound therapy device
16307749|NCT00590356|Device|StarClose®|Closure device for femoral artery suture site occlusion
16307750|NCT00590356|Device|AngioSeal®|Closure device for femoral artery suture site occlusion
16307751|NCT00590343|Drug|vatalanib|Subjects who meet all inclusion and exclusion criteria will receive an initial dose of PTK787/ZK222584 1,250mg once daily, and subjects will remain on the scheduled doses of Sandostatin LAR 30mg every 4 weeks.
16307752|NCT00590317|Drug|Prochlorperazine|Patients receiving Prochlorperazine
16307753|NCT00590317|Drug|Ondansetron|Patients receiving Ondansetron
16307754|NCT00590278|Drug|Tomudex|
16307755|NCT00590278|Procedure|Radiotherapy|
16307756|NCT00590278|Procedure|Haematology|
16307757|NCT00590278|Procedure|Biochemistry|
16307758|NCT00590265|Device|Northern Light Technology (SADelite lamp) bright light-therapy|10 000 lux for 30 minutes
16307759|NCT00590265|Device|Northern Light Technology (SADelite lamp) Dim light-therapy|<100 lux for 30 minutes
16307760|NCT00590226|Drug|Detemir + aspart insulin before meals|Detemir insulin SQ once daily + aspart insulin SQ before meals
16307761|NCT00590226|Drug|NPH insulin + regular insulin|NPH insulin SQ + regular insulin SQ before breakfast and dinner
16307762|NCT00590213|Drug|Casodex 150mg|
16307763|NCT00590213|Procedure|Radiotherapy|
16307764|NCT00590213|Procedure|Haematology|
16307765|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 days every 3-4 weeks
16307766|NCT00590187|Drug|sapacitabine|300 mg b.i.d. x 7 days every 3 - 4 weeks
16307767|NCT00590187|Drug|sapacitabine|400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
16307768|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 consecutive days every 4 weeks
16307769|NCT00590187|Drug|sapacitabine|300 mg q.d. x 7 consecutive days every 4 weeks
16307770|NCT00590187|Drug|sapacitabine|300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
16307771|NCT00590187|Drug|sapacitabine|200 mg b.i.d. x 7 consecutive days every 4 weeks
16307772|NCT00590187|Drug|sapacitabine|300 mg q.d. x 7 consecutive days every 4 weeks
16307773|NCT00590187|Drug|sapacitabine|100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
16307774|NCT00590174|Drug|Aspirin|stopping clopidogrel at 1 year after DES implantation
16307775|NCT00590174|Drug|Aspirin,Clopidogrel|continue aspirin and clopidogrel 1year after DES
16307776|NCT00590161|Drug|pentoxifylline (PTX)|400 mg PO tid
16307777|NCT00590161|Drug|placebo|placebo tid
16307778|NCT00590135|Drug|atorvastatin (Lipitor)|atorvastatin 40 mg by mouth once daily
16307779|NCT00590122|Drug|Parcopa|at subjects current stable dose of comparator
16307780|NCT00590122|Drug|carbidopa-levodopa|at subjects current stable dose
16307781|NCT00590109|Other|Blood test|subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.
16307782|NCT00590109|Other|Questionnaire|A questionnaire encompassing medical, environmental exposure, and reproductive history.
16307783|NCT00590083|Biological|CTL administration|"Adenovirus specific T cells will be given by intravenous injection from day 30 post transplant.
~One infusion of Adenovirus-specific CTL given to patients at risk for Adenoviral disease after matched or mismatched unrelated or matched or mismatched related donor stem cell transplant. Four dose levels will be explored. The lowest level will be 1x dose of 5x10e6cells/m2 and the highest will be 1x dose of 1.35x10e8/m2."
16307784|NCT00590070|Drug|adenosine|Adenosine (80 mcg as fast bolus followed by 2 mg given in 33cc of saline in 2 minutes as slow bolus)
16307785|NCT00590070|Drug|nitroprusside|Nitroprusside (60 mcg as fast bolus followed by 100 mcg given in 33cc of 5% glucose in 2 minutes as slow bolus)
16307786|NCT00590070|Drug|placebo|33 cc of heparinized saline given in 2 minutes as slow bolus
16307787|NCT00590044|Drug|insulin glargine+ glulisine|Daily insulin glargine + glulisine before meals
16307788|NCT00590044|Drug|NPH + Regular insulin|Split-mixed NPH + Regular insulin twice daily
16307789|NCT00590031|Drug|Cisplatin|pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
16307790|NCT00590031|Drug|Irinotecan|Irinotecan will be given 65 mg/m2
16307791|NCT00590031|Radiation|External Beam Radiation Therapy|will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
16307792|NCT00590018|Drug|Hydrocortisone|Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
16307793|NCT00590018|Drug|Placebo|Placebo for 5 days intravenously.
16307794|NCT00589992|Drug|Ibutilide fumarate|During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
16307795|NCT00589979|Drug|Lidoderm (Lidocaine 5% Patch)|Topical Patch
16307796|NCT00589979|Drug|Placebo Patch|Topical Patch
16307827|NCT00589693|Drug|Doripenem|Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 4-hour infusion of doripenem will be administered every 8 hours for 7 days.
16307878|NCT00589420|Drug|docetaxel|
16307797|NCT00589966|Behavioral|Coping Skills Training|Coping Skills Training teaches skills for managing physical, emotional, and social challenges of symptoms commonly experienced by men who have undergone treatment for early stage prostate cancer. Coping skills include activity pacing, managing negative mood, communication enhancement, and applied relaxation.
16307798|NCT00589966|Behavioral|Prostate Cancer Education|Prostate Cancer Education provides information on the following topics: common treatment side-effects, medical options for symptom management, nutrition to support recovery, and guidelines for communicating with your healthcare team.
16307799|NCT00589953|Drug|Erythropoietin|"5 of first 10 subjects (Group 1): 400 units/kg/dose once daily for 7 days 5 of next 10 subjects (Group 2): 800 units/kg/dose once daily for 7 days 20 of next 30 subjects (Group 3): 1000 units/kg/dose once daily for 7 days administered i.v. over 1 hour.
~The volume of the study drug will be 1 mL in a 1 mL Tuberculin syringe to be administered over 1 hour."
16307800|NCT00589953|Drug|Saline placebo|Saline vehicle at a volume of 1 mL given over 1 hour intravenously once a day for the first seven days of life.
16307801|NCT00589927|Drug|cilostazol|cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
16307802|NCT00589927|Drug|placebo|placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
16307803|NCT00589914|Drug|RISPERDAL CONSTA|RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.
16307804|NCT00589914|Drug|Paliperidone palmitate|PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.
16307805|NCT00589901|Drug|capecitabine and cyclophosphamide|"capecitabine 1000 mg/m2 oral Bid d1-14
~cyclophosphamide 65 mg/m2 oral Qd d1-14"
16307806|NCT00589888|Drug|Intralipid 20% @ 20cc/hour|In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting
16307807|NCT00589888|Drug|Intralipid 20%@ 40cc/hour|In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.
16307808|NCT00589888|Drug|Normal Saline|In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.
16307809|NCT00589888|Dietary Supplement|32-gram oral fat load|In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
16307810|NCT00589888|Dietary Supplement|64-gram oral fat load|In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
16307811|NCT00589875|Biological|AdV-tk|Single dose of 3x10e11 vector particles of AdV-tk delivered to the tumor bed after resection on day 0.
16307812|NCT00589875|Drug|Valacyclovir|Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3
16307813|NCT00589862|Drug|Plavix (Clopidogrel)|150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
16307814|NCT00589849|Procedure|T-wave Alternans|T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave
16307815|NCT00589823|Drug|Fentanyl citrate|nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
16307816|NCT00589823|Drug|Immediate release morphine sulphate|drug dose as required by patient taken to treat up to four epsiodes of BTCP per day
16307817|NCT00589797|Device|Activ-L Artificial Disc|Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
16307818|NCT00589797|Device|ProDisc-L Total Disc Replacement or Charité Artificial Disc|Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
16307819|NCT00589784|Drug|Sunitinib|The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.
16307820|NCT00589771|Drug|Saccharomyces boulardii|"Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
~Ispaghula husk 1 Tsf daily after dinner for six weeks"
16307821|NCT00589771|Drug|Placebo|"Cap Placebo TDS for six weeks
~Ispaghula husk 1 Tsf daily after dinner for six weeks"
16307822|NCT00589758|Diagnostic Test|Echocardiography|2D and 3D echocardiography
16307823|NCT00589758|Other|Biomarker evaluation|Blood and urine collected
16307824|NCT00589745|Other|Nasal potential difference measurement|Nasal potential difference measurement involves dripping small amounts of 5 test solutions into the anterior nostril. This is designed to test the ability of the cells to regulate the movement of salt and water in people with features of CF in whom the diagnosis is not entirely clear.
16307825|NCT00589732|Drug|Valsartan|Valsartan 160mg per day
16307826|NCT00589706|Drug|MAb-425|MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
16307871|NCT00589472|Drug|Bicalutamide|Given PO
16307872|NCT00589472|Drug|Goserelin Acetate|Given SC
16307828|NCT00589693|Drug|Imipenem-Cilastatin|Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 1-hour infusion of imipenem-cilastatin will be administered every 8 hours for 10 days.
16307829|NCT00589693|Drug|Placebo|Form=solution, route=intravenous. Doripenem pacebo will be administered from Days 1 to 7 in imipenem-cilastatin arm and imipenem-cilastatin placebo will be administered in doripenem arm.
16307830|NCT00589667|Drug|Pemetrexed plus Gemcitabine|"Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
~Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.
~For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist."
16307831|NCT00589654|Other|Questionnaire|Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.
16307832|NCT00589641|Behavioral|CBT-RP (relapse prevention) + Enhanced TAU|CBT-RP is an 20-week augmenting intervention. CBT-RP is based primarily on Alan Marlatt's cognitive behavioral relapse prevention model for substance abuse, but also includes motivational interviewing and mindfulness meditation approaches. Sessions are twice a week in first week, then weekly thereafter, with tapering to biweekly in the last 8 weeks depending on improvement. Participants also receive treatment as usual, and monthly check-ins regarding treatment use.
16307833|NCT00589641|Behavioral|Enhanced TAU Alone|Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring
16307834|NCT00589628|Drug|infliximab|5mg/kg/dose IV at 4 week intervals
16307835|NCT00589628|Drug|infliximab|10mg/kg/dose IV at 4 week intervals
16307836|NCT00589615|Behavioral|multidisciplinary osteoporosis prevention educational program|The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
16307837|NCT00589602|Procedure|peripheral blood lymphocyte therapy|T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.
16307838|NCT00589602|Procedure|allogeneic hematopoietic stem cell transplantation|Allogeneic Hematopoietic Stem Cell Transplantation
16307839|NCT00589602|Procedure|peripheral blood stem cell transplantation|Peripheral blood stem cell transplantation
16307840|NCT00589602|Radiation|total-body irradiation (TBI)|Treatment will be delivered using 6MV photons twice daily for 3 days
16307841|NCT00589589|Device|Endo Tool|Computer tool to help achieve glucose control
16307842|NCT00589563|Biological|anti-thymocyte globulin|0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.5 mg/kg on day -1 or day 0 from stem cell transplant
16307843|NCT00589563|Drug|cyclophosphamide|60mg/kg on days -5 and -4 from stem cell transplant
16307844|NCT00589563|Drug|etoposide|60mg/kg on day -4 from stem cell transplant
16307845|NCT00589563|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant
16307846|NCT00589563|Drug|melphalan|Melphalan 140 mg/m2 on day -4 from stem cell transplant
16307847|NCT00589563|Drug|methotrexate|For high risk HLA-mismatch transplant only: 5 mg/m2 on days +1, +3 and +6 from stem cell transplant
16307848|NCT00589563|Drug|sirolimus|"Adults: 12 mg loading dose on day -3 from stem cell transplant followed by 4 mg orally single morning daily dose.
~Pediatric Patients <40kg: 3 mg/m2 orally on day -3 from stem cell transplant followed by 1 mg/m2 orally single morning daily dose"
16307849|NCT00589563|Drug|tacrolimus|0.02 mg/kd/d CIV beginning on day -3 from stem cell transplant
16307850|NCT00589563|Procedure|allogeneic hematopoietic stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
16307851|NCT00589563|Procedure|hematopoietic stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
16307852|NCT00589563|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant, Melphalan 140 mg/m2 on day -4 from stem cell transplant
16307853|NCT00589563|Procedure|peripheral blood stem cell transplantation|The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight
16307854|NCT00589563|Radiation|total-body irradiation|1320 cGy in 11 fractions from day -8 to day -5 or day -9 to day -6 prior to stem cell transplant
16307855|NCT00589550|Biological|PEG-interferon alfa-2b|administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
16307856|NCT00589550|Drug|Sorafenib|
16307857|NCT00589550|Genetic|gene expression analysis|
16307858|NCT00589550|Genetic|polymerase chain reaction|
16307859|NCT00589550|Genetic|reverse transcriptase-polymerase chain reaction|
16307860|NCT00589550|Other|flow cytometry|
16307861|NCT00589550|Other|immunoenzyme technique|
16307862|NCT00589550|Other|laboratory biomarker analysis|
16307863|NCT00589537|Other|questionnaire administration|
16307864|NCT00589537|Procedure|computed tomography|
16307865|NCT00589537|Procedure|magnetic resonance imaging|
16307866|NCT00589537|Procedure|quality-of-life assessment|
16307867|NCT00589524|Device|Computed tomography (CT)|Computed tomography (CT), as performed by Dual Source Computed Tomography (DSCT)(Siemens Medical Solutions Germany) to be conducted no sooner than 3 days before or after cardiac catheterization, but with 3 months of the cardiac cath.
16307868|NCT00589498|Dietary Supplement|1000 extra calories|Each subject received 1000 kcal/d in addition to weight maintenance requirements. The diet composition throughout the study was 40% carbohydrate, 40% fat, and 20% protein.
16307869|NCT00589485|Device|Simplex® Bone Cement|This arm will utilize Simplex® Bone Cement in total knee replacement.
16307870|NCT00589485|Device|Cobalt™ Bone Cement|This arm utilizes Cobalt™ Bone Cement in total knee replacement.
16307880|NCT00589394|Biological|pneumococcal vaccination (Pneumovax)|pneumovax was given
16307881|NCT00589381|Drug|fenretinide lipid matrix|
16307882|NCT00589368|Behavioral|Transfer of grasp control across hands|transfer of planning and execution of grasp across hands in terms of its effect on fingertip forces, and the timing and magnitude of muscle contraction in patients with hemiparesis and healthy controls
16307883|NCT00589329|Drug|erythromycin and metronidazole (antibiotics)|"Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days.
~Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days"
16307884|NCT00589329|Drug|placebo|IV and pill placebo
16307885|NCT00589316|Procedure|Allogeneic Bone Marrow Transplantation|Given via central line
16307886|NCT00589316|Drug|Cyclophosphamide|Given IV
16307887|NCT00589316|Drug|Fludarabine Phosphate|Given IV
16307888|NCT00589316|Radiation|Iodine I 131 Monoclonal Antibody BC8|Given IV (dosimetry dose) or via central line (therapeutic dose)
16307889|NCT00589316|Other|Laboratory Biomarker Analysis|Correlative studies
16307890|NCT00589316|Drug|Mycophenolate Mofetil|Given IV or PO
16307891|NCT00589316|Drug|Tacrolimus|Given IV or PO
16307892|NCT00589316|Radiation|Total-Body Irradiation|Undergo TBI
16307893|NCT00589303|Drug|FDA approved rate and rhythm control drugs|"Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.
~Rate Control:
~Beta-Blocker:
~metoprolol
~atenolol
~carvedilol
~Calcium Channel Blocker:
~verapamil
~diltiazem
~Rhythm Control:
~procainamide
~quinidine
~disopyramide
~propafenone
~flecainide
~sotalol
~dofetilide
~amiodarone"
16307894|NCT00589303|Device|AV Node ablation and device implant|"Pacing Systems:
~Enpusle Premarket Approval Number (PMA#) P980035
~EnRhythm PMA# P980035
~Adapta PMA# P980035
~Cardiac Resynchronization Therapy (CRT) Pacing Systems:
~- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031
~Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:
~EnTrust PMA# P980016
~Virtuoso PMA# P980016
~ICD CRT Pacing Systems:
~InSync Maximo PMA# P980016
~InSync Sentry PMA# P890003
~Concerto PMA# P980016"
16307895|NCT00589290|Drug|Belinostat (PDX101)|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
16307896|NCT00589277|Behavioral|Gain-Framed counseling & Gain-framed materials|Novel messages for quitting smoking
16307897|NCT00589277|Behavioral|Standard care counseling + standard materials|Standard messages for quitting smoking
16307898|NCT00589264|Dietary Supplement|zinc|10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age
16307899|NCT00589264|Dietary Supplement|iron + copper|10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age
16307900|NCT00589251|Other|penicillin skin test|"Prick skin tests will be performed on the volar surface of the forearm with each penicilloate and control reagents. The skin test sites will be examined at 15 minutes. A positive test result is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. Patients with negative prick test results to penicillin will undergo intradermal testing.
~Intradermal skin tests will be performed on the volar surface of the forearm. The test reagents will be injected intradermally to produce an initial wheal of 2x2 mm. The skin test sites will be examined at 15 minutes. A positive intradermal test is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. In order to ensure patient safety, we will consider using an end point titration technique."
16307901|NCT00589238|Drug|carboplatin|
16307902|NCT00589238|Drug|cyclophosphamide|
16307903|NCT00589238|Drug|doxorubicin hydrochloride|
16307904|NCT00589238|Drug|paclitaxel|
16307905|NCT00589225|Genetic|Genetic Analysis|We will draw one tube of blood from your arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing.
16307906|NCT00589212|Device|GliaSite Radiation Therapy System|GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.
16307907|NCT00589199|Procedure|Placement and use of the device|Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.
16307908|NCT00589186|Biological|Ad5F35-LMP1/LMP2-transduced autologous dendritic cells|
16307909|NCT00589186|Drug|celecoxib|
16307910|NCT00589186|Other|flow cytometry|
16307911|NCT00589186|Other|immunoenzyme technique|
16307912|NCT00589186|Other|laboratory biomarker analysis|
16307913|NCT00589173|Behavioral|Interactive Preventive Health Record (IPHR)|Preventive health record designed to a) show patients the status of their preventive care recorded in their electronic record and b) make recommendations on what USPSTF endorsed preventive services that the user needs to receive.
16307914|NCT00589173|Behavioral|"Standard preventive care"|Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).
16307915|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, modular cemented tibia|modular cemented tibia
16307916|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.|non-modular cemented tibia.
16307917|NCT00589147|Device|The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia|non-modular uncemented tibia
16307918|NCT00589134|Dietary Supplement|Gatorade Endurance Formula|carbohydrate electrolyte beverage
16307919|NCT00589134|Other|ganirelix acetate|GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days.
16307920|NCT00589121|Drug|Chemotherapy|Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
16309094|NCT00578695|Drug|Placebo|Oral Capsule
16307921|NCT00589121|Radiation|Radiation therapy|Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost.
16307922|NCT00589121|Procedure|Surgery|Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision.
16307923|NCT00589108|Device|Sigma Knee System|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
16307924|NCT00589108|Device|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
16307925|NCT00589108|Device|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray|Sigma Pressfit Condylar Posterior Cruciate Substituting System (fixed bearing with an all polyethylene tray)
16307926|NCT00589095|Other|dynamic contrast enhanced magnetic resonance imaging|dynamic contrast enhanced MRI using contrast agent gadodiamide
16307927|NCT00589082|Drug|DaunoXome|
16307928|NCT00589082|Drug|Daunorubicine|
16307929|NCT00589056|Drug|cisplatin|
16307930|NCT00589056|Drug|etoposide|
16307931|NCT00589056|Drug|nelfinavir mesylate|
16307932|NCT00589056|Genetic|protein expression analysis|
16307933|NCT00589056|Other|immunohistochemistry staining method|
16307934|NCT00589056|Other|laboratory biomarker analysis|
16307935|NCT00589056|Procedure|biopsy|
16307936|NCT00589056|Radiation|radiation therapy|
16307937|NCT00589030|Radiation|brachytherapy|The target dose of TheraSphere® is 80-150Gy
16307938|NCT00589030|Radiation|yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150Gy
16307939|NCT00588991|Drug|Carboplatin|Given IV
16307940|NCT00588991|Other|Laboratory Biomarker Analysis|Correlative study
16307941|NCT00588991|Drug|Topotecan Hydrochloride|Given IV
16307942|NCT00588991|Drug|Veliparib|Given orally
16307943|NCT00588978|Behavioral|diet and/or exercise|Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
16307944|NCT00588965|Drug|Placebo|Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test.
16307945|NCT00588965|Drug|Propranolol LA|Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test.
16307946|NCT00588952|Drug|Ketamine and Placebo|Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes
16307947|NCT00588939|Device|Cell~vizio (Laser connfocal microscopy)|completed during endoscopy
16307948|NCT00588926|Drug|Remifentanil|After the mapping electrode is in situ, recording of baseline electrical activity is done for two-three minutes and an infusion of Remifentanil, 0.1 microgram per kilogram per minute is started. This procedure continues for a few minutes until the patient is sedated and then the infusion is stopped and the patient allowed to recover. The recordings continue during the whole procedure.
16307949|NCT00588913|Biological|aldesleukin|
16307950|NCT00588913|Biological|therapeutic autologous lymphocytes|
16307951|NCT00588913|Drug|zoledronic acid|
16307952|NCT00588900|Drug|cediranib maleate|
16307953|NCT00588900|Drug|irinotecan hydrochloride|
16307954|NCT00588887|Device|Duracon®|This group utilizes the Duracon® prostheses for total knee replacement.
16307955|NCT00588887|Device|Vanguard™|This group will utilize the Vanguard™ prostheses for total knee replacement.
16307956|NCT00588861|Device|Answer® hip stem|Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
16307957|NCT00588861|Device|Answer® hip stem|Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
16307958|NCT00588848|Device|Autoadjusting CPAP (VPAP Auto)|An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).
16307959|NCT00588848|Device|CPAP|Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)
16307960|NCT00588835|Drug|aprepitant|125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
16307961|NCT00588835|Drug|Dexamethasone and Ondansetron during CE-treatment|Standard anti-emetic regimen during CE treatment
16307962|NCT00588822|Biological|Rituximab|Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22).
16307963|NCT00588809|Drug|selumetinib|Given PO
16307964|NCT00588783|Device|I-beam design|This group will utilize tibial components with an I-beam design for total knee replacement.
16307965|NCT00588783|Device|Cruciate design|This group will utilize tibial components with cruciate designs for total knee replacement.
16307972|NCT00588757|Device|Optease IVC filters|IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
16307973|NCT00588757|Device|Gunter-Tulip IVC filters|IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
16307974|NCT00588731|Drug|Cannabidiol|Active Cannabidiol daily over 6 weeks
16307975|NCT00588731|Drug|Placebo|Placebo
16308006|NCT00588393|Drug|FolateScan (Technetium Tc 99mEC20)|0.1 mg. of EC20 labeled with 20-25 mCi of technetium-99m followed by FolateScan
16308202|NCT00586547|Biological|T-Cell Infusion Dose Level 3|(1 x 10^6 T cells/Kg)
16307976|NCT00588705|Behavioral|focus group & questionaire|The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.
16307977|NCT00588692|Device|SphygmoCor|The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure.
16307978|NCT00588679|Other|Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging|All MR examinations will be performed on a 3.0 Tesla whole body GE MR scanner located at the main campus (1275 York Avenue) or the Breast and Imaging Center (BAIC)(located on Second Ave. between 65th and 66th Streets). The MR examination will include MR imaging and spectroscopic imaging employing a combined torso phased array and endorectal coil receiver. The examination will require one hour to one hour and ten minutes.
16307979|NCT00588666|Drug|Bevacizumab|
16307980|NCT00588666|Drug|Carboplatin|
16307981|NCT00588666|Drug|Gemcitabine|
16307982|NCT00588653|Device|Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through|Each patient undergoes each of the 4 diagnostic modalities, but the readers are blinded to results of the other 3.
16307983|NCT00588640|Drug|d-Methadone|8 subjects to receive 40 mg d-Methadone twice a day
16307984|NCT00588640|Drug|D-methadone|After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
16307985|NCT00588640|Drug|placebo|After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
16307986|NCT00588588|Procedure|Bronchoscopy|Bronchoscopy procedure
16307987|NCT00588588|Procedure|Clinical pulmonary infection score (CPIS)|Calculate CPIS
16307988|NCT00588536|Drug|Methotrexate|MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
16307989|NCT00588536|Drug|6-Thioguanine|6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
16307990|NCT00588536|Drug|Leucovorin Calcium|5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)
16307991|NCT00588523|Drug|temozolomide followed by high dose busulfan and thiotepa|Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion
16307992|NCT00588510|Other|Blood draw|Peripheral blood samples (6-9 ml) will be collected in purple top tubes, when routine laboratory tests are being drawn. The blood will be drawn through central venous catheters, whenever possible. Blood will be drawn once from patients with malignant diagnoses other than osteosarcoma, neuroblastoma, Ewing's sarcoma or synovial sarcoma. In patients with osteosarcoma we will obtain blood when baseline laboratory tests are obtained, after every two cycles of treatment (approximately every six weeks), at the end of planned surgery and chemotherapy, every three months for the first year off therapy and yearly thereafter. We will also obtain blood if the patient relapses.
16307993|NCT00588497|Procedure|Micro-insert hysteroscopic sterilization|Placement of micro-inserts transcervically with the aid of a hysteroscope
16307994|NCT00588497|Radiation|Plain abdominal Xray|Performed immediately after micro-inserts placement and at 3 months
16307995|NCT00588497|Procedure|Pelvic Ultrasound|Performed immediately after micro-inserts placement and at 3 months.
16307996|NCT00588497|Radiation|Hysterosalpingogram|Performed 3 months after micro-inserts placement
16307997|NCT00588471|Drug|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
16307998|NCT00588471|Drug|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
16307999|NCT00588458|Procedure|CT cholangiography|Cholografin 20ml will be diluted in 100 ml of normal saline and infused over 30 minute time interval. Following the infusion of the cholografin, morphine (0.04 mg/kg) will be administered to contract the sphincter of Oddi and improve bile duct distension and visualization. Thirty minutes following the administration of morphine a test scan (CT cholangiography) will be performed through the liver to determine if there is adequate biliary excretion. The test scan will consist of 10 mm thick image obtained through the mid liver. If there is evidence of biliary excretion, high-resolution images will be performed through the liver and bile ducts. The axial images will be reconstructed into maximum intensity projection models and volume rendered models that can be viewed in 3-dimension.
16308000|NCT00588445|Drug|Gefitinib|"Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
16308001|NCT00588419|Behavioral|breast exam and questionaire|A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.
16308002|NCT00588406|Drug|Budesonide|2mg/dose by nebulizer, four doses over 3 hours
16308003|NCT00588406|Drug|albuterol|2.5mg/dose by nebulizer, 7 doses over 6 hours
16308004|NCT00588406|Drug|Ipratropium bromide|2.5 mg, one dose
16308005|NCT00588406|Drug|Prednisone|60mg PO
16308007|NCT00588380|Drug|GLP-1|GLP-1 infused at 0.75 pmol/kg/min from 121-180 minutes, GLP-1 infused at 1.55 pmol/kg/min from 181-240 minutes,
16308008|NCT00588367|Device|Mayo Interactive Breath Hold Monitor|Biofeedback device
16308009|NCT00588354|Drug|Clonidine|200 or 400 micrograms clonidine
16308010|NCT00588354|Drug|Triamcinolone hexacetonide|40 or 80 milligrams triamcinolone
16308011|NCT00588354|Drug|Lidocaine HCl|1 ml 2% lidocaine (20 mg/mL)
16308012|NCT00588341|Drug|Temozolomide|"At the start of the trial a core needle biopsy of a palpable tumor will be obtained percutaneously in the office after administration of local anesthesia. Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks. After each cycle, patients will be re-evaluated for response.
~Responding patients will be offered another cycle of treatment. Patients will be treated until best response, progression of disease, or 6 cycles, whichever comes first.
~After completing temozolomide treatment, patients will be evaluated for surgical resection. It is expected that, unless there is progression of disease, patients will undergo resection (i.e. therapeutic lymph node dissection). In patients who have a complete clinical response to temozolomide, whether or not to do a subsequent lymph node dissection will be left up to the discretion of the surgeon and the patient."
16308013|NCT00588328|Device|PET/CT scan|PET/CT scans
16308014|NCT00588302|Drug|Moexipril|Moexipril was given at a starting dose of 7.5 mg daily for 1 week to all enrolled patients. If tolerated (no clinically significant hypotension or medication associated adverse event), the daily dosage was increased to 15 mg daily at the beginning of the 2nd treatment week. Patients took moexipril orally in the morning and 1 hour prior to food intake. The target dose was maintained for the 1-year period of the study unless the development of toxicities warranted dose reduction or discontinuation.
16308015|NCT00588276|Radiation|124I-Iodo-Azomycin Galacto-Pyranoside|You will receive the radioactive tracer through an injection in your vein. Blood (about 5 tablespoons in all) will be taken after the radioactive tracer has been given. Over the course of study day 1, bloods will be drawn 8 times and then 4 more times on study day 2. You will undergo three *IAZGP PET scans, one shortly after you receive the injection, one later the same day and one the following day. Each scan will take about an hour. This means you would be asked to come back 2 days in a row.
16308016|NCT00588250|Other|EmbryoGlue|G2 culture media from Vitrolife which contains hyaluronic acid
16308017|NCT00588237|Drug|Paclitaxel,Cisplatin, Bevacizumab|IV paclitaxel, followed by IV Bevacizumab on Day 1. Bevacizumab treatment will begin cycle 2, day 1. IP cisplatin will be given on Day 2, and IP Paclitaxel on Day 8. Subjects will receive up to six cycles of therapy, or until disease progression or unacceptable toxicity.
16308018|NCT00588224|Other|3D ultrasound|measurement of stomach volume by 3D ultrasound
16308019|NCT00588211|Behavioral|Interviews|45-minute individual interviews after the conclusion of their dental appointment
16308020|NCT00588211|Behavioral|focus group|A focus group of the preliminary cancer-related risk perception item pool.
16308021|NCT00588211|Behavioral|Survey|Quantitative item analysis of the final item pool.
16308022|NCT00588211|Behavioral|Survey|A second confirmatory factor analysis.
16308023|NCT00588185|Drug|[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone|Registered patients will undergo PET scanning using either FDHT alone or FDG and FDHT depending on the clinical question being asked. Scans will be performed serially at baseline, week 4, week 12, and every 12 weeks of treatment up to a maximum of 8 FDHT/FDG scan set in a 12 month period (maximum 40 scan sets per lifetime) unless the therapeutic protocol or scientific rationale of the therapeutic drug being applied specifically dictates an alternative schedule. Patients may have blood drawn for the purposes of establishing the pharmacokinetics of FDHT and may also undergo an initial dynamic scan if further pharmacokinetic information is warranted, followed by a standard whole body image. If no further pharmacokinetic information is warranted, then patients will only undergo a standard whole body image.
16308024|NCT00588172|Drug|Metformin|1000mg bid for 1 week
16308025|NCT00588159|Drug|Gabapentin|gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
16308026|NCT00588159|Drug|Diphenhydramine|Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
16308027|NCT00588146|Drug|Pegylated Interferon Alpha2b|Weekly subcutaneous injection of 1 microgram/kg/week
16308028|NCT00588146|Other|Standard care|Standard care
16308029|NCT00588133|Drug|tranexamic acid|"Loading dose: 6.6 mg/kg Prime dose: 50 mg for 2.5 Liter circuit (assuming 1 L/kg Vd in prime fluids), 40 mg for 2 Liter circuit Rate of infusion: 6 mg/kg/hr
~Renal Insufficiency (normal loading dose and prime dose):
~Serum Creatinine = 1.6-3.3: reduce infusion to 4.5 mg/kg/hr Serum Creatinine = 3.3-6.6: reduce infusion to 3.0 mg/kg/hr Serum Creatinine = >6.6: reduce infusion to 1.5 mg/kg/hr"
16308030|NCT00588133|Drug|tranexamic acid|10 mg/kg tranexamic acid given over 20 minutes followed by an infusion of 1 mg/kg/hr
16308031|NCT00588120|Drug|C-13 labeled oxalate|"A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose.
~Take one capsule by mouth for one day."
16308032|NCT00588107|Other|Web Intervention|Receives pharmacotherapy and access to an interactive Web site (Web condition). The Web site will offer tailored intervention messages and strategies in an interactive format that is much less labor-intensive and costly than the prior PFH peer telephone counseling intervention.
16308033|NCT00588107|Behavioral|print materials|tailored print materials designed to aid in smoking reduction and cessation
16308058|NCT00587821|Other|Blood draw|Peptide profiles from blood samples of all subjects will be determined by mass spectrometric analysis.
16308059|NCT00587808|Procedure|RHC with VO2 consumption|All pressure-volume data is acquired at 250 Hz and stored on the Leycom system for offline analysis. Volume data will be calibrated using the most recent EF from echocardiogram and stroke volume from the Fick method. Measured O2 consumption will be utilized along with sampling of SVC and arterial blood oximetry to determine cardiac output at rest and during exercise
16308034|NCT00588094|Drug|Rituximab, Ifosfamide, Carboplatin, VP-16, Mesna, G-CSF, Stem Cell Transplant|"ANC must be ≥1000/µl and platelet count must be ≥50,000/µl. Rituximab will be administered at a dose of 375 mg/m2 IV on days 1 and 3 of the each cycle. Premedication will be given.ICE will be administered as follows: Day 3: Etoposide 200 mg/m2 IV q12 hrs x 3. Day 4: Ifosfamide 10 g/m2 and MESNA 10 g/m2 mixed and infused together as a continuous infusion over 48 hours. Day 5: Carboplatin IV dosed by the Calvert formula using an AUC of 5.
~Carboplatin dose (mg) = 5 x (Clcr + 25) For the first ten patients enrolled, G CSF will be administered beginning on day seven of each cycle and G CSF will continue until stem cell collection is completed. The dose will be 960 ug or 10 ug/kg if weight is greater than 100 kg.
~For the remaining patients, G-CSF will be administered for 10 days beginning on day 7 for cycle 1. The dose will be 300-480 ug/d. For cycle 2 the dose will be 960 ug or 10ug/kg if weight is > 100kg. Leukapheresis will continue."
16308035|NCT00588081|Behavioral|QOL|Those women who chose to have an interview will be scheduled for a 45 to 60 minute open-ended interview with a trained research assistant and sign consent at the time of the interview.
16308036|NCT00588068|Other|Tumor and Marrow Markers|Tumor and Marrow Markers
16308037|NCT00588042|Device|Blood pressure cuff|Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes
16308038|NCT00588042|Device|blood pressure cuff|3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
16308039|NCT00588016|Drug|Itraconazole|Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.
16308040|NCT00588003|Drug|anastrozole|anastrozole 1mg/day 11 days before their surgery and to take the last dose of the oral endocrine agent (anastrozole) on the day before their surgery.
16308041|NCT00588003|Other|Placebo|No medication before surgery
16308042|NCT00587990|Biological|Lower dose mesenchymal stem cell (MSC) injection|Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10^7 cells. The injections will be administered following completion of CABG surgery.
16308043|NCT00587990|Genetic|Placebo|Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
16308044|NCT00587990|Biological|Higher dose MSC injection|Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10^8 cells. The injections will be administered following completion of CABG surgery.
16308045|NCT00587964|Radiation|Stereotactic Radiosurgery|"All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. The patient will initially receive premedication with 0.5- 1mg of Ativan orally prior to SRS procedure. Subsequently, the patient will have the stereotactic head ring placement under local anesthesia. A peripheral IV will be placed for administration of the intravenous contrast. Thin-section CT images will be obtained with intravenous contrast with head ring in place for the purpose of treatment planning.
~A fusion program will be used to combine the recently obtained MRI images along with the CT scans. The target volume as well as the critical structures will be contoured. SRS would be delivered using either the Brain Lab or Radionics Radiosurgery planning and delivery system. Patients would receive a single treatment ranging from 15-22 GY."
16308046|NCT00587925|Other|Bone Mineral Density|Clinic visits twice during the first 2 years of the study with medical care directed by your treating doctor.BMD is measured by an X-ray test. The most common type of BMD testing is by energy x-ray absorptiometry (DEXA). Usually BMD is measured every other year, but to closely monitor women on this study, the BMD will be evaluated more often. The BMD will be measured 3 times (baseline, 12 months and 24 months) on this study. Study blood work is obtained three times (baseline, 6 months, and 12 months). Blood (about 3 teaspoons).
16308047|NCT00587899|Procedure|Pulmonary Vein Isolation|The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
16308048|NCT00587886|Behavioral|Questionnaire|The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.
16308049|NCT00587886|Behavioral|Questionnaire|"The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.
~We will conduct interviews mainly by telephone but also in person (at home or another convenient place)if the participant prefers."
16308050|NCT00587873|Drug|Methotrexate|MTX 6mg/m2 given IV bolus, followed by 24mg/m2 given in 24hrs continuous infusion
16308051|NCT00587873|Drug|Leucovorin calcium|5 mg orally at 12 hours after the end of MTX infusion then every 12 hrs for a total of 3 doses.
16308052|NCT00587873|Drug|6-Thioguanine|6-TG 300 mg/m2 PO as a single oral dose
16308053|NCT00587860|Drug|St. John's wort|Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
16308054|NCT00587860|Drug|Placebo|Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day
16308055|NCT00587847|Drug|Campath|Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
16308056|NCT00587834|Device|Gintuit|Application of Gintuit at Day 0 to the gingival bed
16308057|NCT00587834|Other|Autologous palatal tissue|Tissue will be harvested from the subject's palate and placed on the gingival bed
16308101|NCT00587431|Drug|GnRh (Leuprolide)|Leuprolide LUPRON
16308060|NCT00587795|Device|StabilAir Wrist Brace|Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.
16308061|NCT00587795|Other|Placement of sugar tong splint or plaster cast|Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.
16308062|NCT00587769|Drug|Bupropion SR & Varenicline|"Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day.
~Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment."
16308063|NCT00587756|Procedure|One-stage ultrasound guided hepatectomy|Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.
16308064|NCT00587730|Device|GE Attenuation Corrected Hawkeye Camera|GE Hawkeye AC system and 360˚ camera orbit
16308065|NCT00587717|Drug|simvastatin|Two 80 mg pills simvastatin taken 24 hours prior to surgery
16308066|NCT00587717|Drug|placebo|take 2 80 mg pills placebo 24 hours prior to surgery
16308067|NCT00587704|Procedure|PVB using nerve stimulation|5ml of 1% ropivacaine injected incrementally
16308068|NCT00587704|Procedure|PVB using anatomic landmarks|5ml of 1% ropivacaine injected incrementally
16308069|NCT00587691|Biological|Tovaxin Autologous T Cell Vaccine|"Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period.
~Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods.
~Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods."
16308070|NCT00587678|Drug|Simvastatin|40mg each night
16308071|NCT00587678|Drug|Ezetimibe|10mg daily
16308072|NCT00587678|Drug|Simvastatin/Ezetimibe|40mg/10mg each night
16308073|NCT00587665|Drug|ketamine|Single IV dose of 0.1 mg/kg of ketamine
16308074|NCT00587665|Drug|Placebo|Saline given of equal volume to drug
16308075|NCT00587639|Device|rTMS Treatment|Active rTMS treatment.
16308076|NCT00587626|Device|Inactive InterX 5000|Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
16308077|NCT00587626|Device|InterX 5000 Treatment|Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
16308078|NCT00587600|Procedure|Photodynamic therapy|Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.
16308079|NCT00587600|Procedure|radiofrequency ablation of barrett's esophagus|radiofrequency ablation
16308080|NCT00587587|Device|Apligraf|Application at Day 0, potential re-application at Week 4
16308081|NCT00587587|Other|Standard dressing regimen|A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
16308082|NCT00587561|Behavioral|Social Cognition Interaction Training|manualized group therapy
16308083|NCT00587561|Behavioral|WLC|wait-list control for 6 months, followed by the experimental group therapy
16308084|NCT00587548|Other|Localizing the ureters during surgery|One-time injection 4.5mCi of 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be utilized for ureter location.
16308085|NCT00587522|Device|NDO Full-thickness Plicator|The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.
16308086|NCT00587496|Drug|valacyclovir hydrochloride|500 mg capsule, one per day for 30 days
16308087|NCT00587496|Drug|placebo|lactose placebo capsule, six per day for 30 days
16308088|NCT00587496|Drug|valacyclovir plus aspirin|500 mg valacyclovir capsule, one per day for 30 days 325 mg acetyl salicylic acid (aspirin) capsule, three per day for 30 days placebo capsule, two per day for 30 days
16308089|NCT00587483|Drug|Lidocaine|Lidocaine is a class I (sodium channel block) antiarrhythmic drug
16308090|NCT00587483|Drug|Amiodarone|300 mg
16308091|NCT00587483|Drug|Placebo|Saline
16308092|NCT00587470|Drug|Candesartan|Maximum vasodilation.
16308093|NCT00587470|Drug|atacand|maximum vasodilation
16308094|NCT00587470|Drug|Placebo|Placebo
16308095|NCT00587457|Drug|CAT-8015 5 mcg/kg|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
16308096|NCT00587457|Drug|CAT-8015 10 mcg/kg|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
16308097|NCT00587457|Drug|CAT-8015 20 mcg/kg|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
16308098|NCT00587444|Drug|Heparin|300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds
16308099|NCT00587444|Drug|HH or high heparin|initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB
16308100|NCT00587444|Drug|heparin concentration HC|"will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB.
~All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%"
16308102|NCT00587431|Drug|Testosterone Gel|Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
16308103|NCT00587431|Drug|Docetaxel|70 mg/m2 given on day o1 of each 3 week cycle
16308104|NCT00587418|Dietary Supplement|L-arginine|Arginaid (Novartis) 1 package (9.2g) bid for 7 days
16308105|NCT00587418|Dietary Supplement|Placebo|Placebo powder 9.2g bid for 7 days
16308106|NCT00587405|Procedure|cryotherapy|"The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.
~A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy."
16308107|NCT00587405|Procedure|Argon Plasma Coagulation|As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
16308108|NCT00587392|Device|NDO Full-thickness Plicator|The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.
16308109|NCT00587379|Drug|Atorvastatin|40 mg atorvastatin pill daily
16308110|NCT00587379|Drug|placebo|40 mg pill per day
16308111|NCT00587353|Other|Behavioral and pharmacologic tobacco use intervention|A novel approach to providing an intervention for tobacco users who are receiving radiation therapy is to provide an individual tobacco use intervention that utilizes concepts of motivational interviewing strategies to facilitate self-exploration of the reasons for continued smoking and a treatment plan that is comprehensive and builds self-efficacy, provides one-on-one counseling, and includes tobacco treatment pharmacotherapies. The pharmacotherapies will be tailored to the patients needs. One could utilize varenicline, bupropion, and/or nicotine replacement therapies.
16308112|NCT00587327|Drug|Barusiban|Solution for IV treatment. Bolus and infusion for 4 hours
16308113|NCT00587327|Drug|Atosiban|Solution for IV administration. Bolus and infusion for 4 hours
16308114|NCT00587327|Drug|Placebo|Saline solution for IV administration. Bolus and infusion for 4 hours.
16308115|NCT00587314|Other|Biopsy|Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus
16308116|NCT00587301|Device|Lap-Band|Obesity and adolescents
16308117|NCT00587288|Biological|Reslizumab|
16308118|NCT00587288|Other|Saline|
16308119|NCT00587275|Drug|AST-120|Oral, sachet, 2 grams daily for 4 weeks
16308120|NCT00587275|Drug|Celphere CP-305|Oral, sachet, 2 grams daily for 4 weeks
16308121|NCT00587249|Biological|Malaria ICC-1132|ICC-1132, a candidate malaria vaccine, with alhydrogel will be in 2 ml glass vials containing ICC-1132 at either 40 mcg/ml or 100 mcg/ml concentration formulated with alhydrogel at 1mg/ml. Each vial will contain approximately 0.8 ml solution to permit recovery of 0.5 ml for injection. When shaken, the solution is off-white to greyish-white turbid liquid free of foreign particulate matter.
16308122|NCT00587249|Biological|Alhydrogel|Aluminum hydroxide gel.
16308123|NCT00587223|Device|Apligraf|Up to 3 applications: Day 0, Month 1, Month 2.
16308124|NCT00587223|Other|Standard dressing regimen|Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer
16308125|NCT00587171|Device|Patching|2 hours daily patching
16308126|NCT00587171|Procedure|Near activities|30 minutes daily near activities at home
16308127|NCT00587171|Procedure|Active vision therapy|30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session
16308128|NCT00587171|Procedure|Control vision therapy|30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session
16308129|NCT00587158|Drug|Paricalcitol|Zemplar® - this medicine, which is the medicine being studied, will be given as a capsule containing 1 microgram of Zemplar® once daily beginning the day after the transplant. It will be continued at the same dose for the first two weeks then, depending on the results of blood and urine testing, will be increased to 2 micrograms daily. The dose will remain at 2 micrograms daily until the end of the study unless there is a medical reason to reduce or stop it or unless the study is stopped early.
16308130|NCT00587158|Other|Corticosteroid Avoidance Immune Suppression Protocol|Induction with Alemtuzumab and maintenance with Tacrolimus and Mycophenolate Mofetil. With standard antimicrobial prophylaxis and calcium supplementation.
16308131|NCT00587145|Drug|S-1,Docetaxel|"S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
~Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8"
16308132|NCT00587132|Drug|Synthetic Human Secretin|0.2mcg/kg one time dose.
16308133|NCT00587119|Drug|Budesonide|Oral Budesonide, 3 mg three times daily, will be given for 1 year.
16308134|NCT00587093|Other|CA 125 and CT scan|Within 14 days prior to surgery serum for CA125 will be obtained. The patient will also undergo a CT scan of the abdomen and pelvis with oral and intravenous contrast within 35 days prior to the procedure.
16308135|NCT00587067|Drug|FLOXURIDINE|"[0.16* mg/kg/day X 30 ml] / pump flow rate
~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
16308165|NCT00586820|Drug|BQ-123|BQ-123 is a cyclic peptide consisting of five amino acids. BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
16308136|NCT00587054|Drug|cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant|"Myeloablative and will consist of hyperfractionated TBI - 1375 cGy administered in 11 doses of 125 cGy each over a total of four days, with three doses on three days and two doses on the last day, fludarabine 25 mg/m2 IV x 5 days, and thiotepa 5mg/kg IV x 2 days. Recipients of HLA identical related transplants will not receive ATG to promote engraftment. Recipients of HLA mismatched related or unrelated stem cells will receive ATG for two days prior to the transplant. G-CSF mobilized CD34+E- PBSCs obtained from the HLA compatible donor will be infused on day 0. Post transplantation G-CSF will be administered only if clinically indicated and should begin on or after d+7.
~Patients will be clinically evaluated at each clinic visit for incidence and severity of acute and chronic GVHD and transplant associated morbidity. Sequential evaluation of functional reconstitution of hematopoiesis and immunity will be made as per the BMT Service guidelines."
16308137|NCT00587041|Dietary Supplement|Oxadrop|Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis).
16308138|NCT00587041|Dietary Supplement|Agri-King Synbiotic (AKSB)|AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
16308139|NCT00587041|Other|Placebo|1 placebo packet daily and 1 placebo capsule twice daily
16308140|NCT00587015|Drug|CAT-8015|The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes.
16308141|NCT00587002|Procedure|IVUS|Intravascular ultrasound with virtual histology
16308142|NCT00586989|Procedure|Upper endoscopy with biopsy|Endoscopy with biopsy 6 weeks after the initial endoscopy
16308143|NCT00586976|Drug|Ropivacaine|0.3% ropivacaine infusion at 4 ml/hr for 64 hours.
16308144|NCT00586976|Drug|Normal saline|Normal saline infusion at 4 ml/hour for 64 hours.
16308145|NCT00586937|Behavioral|questionnaires or telephone interview|In the first phase, a random sample of lung cancer survivors will complete a comprehensive telephone interview or questionnaire by self-report focusing on assessment of quality of life and related covariates. We estimate the total time for completion of the survey by telephone interview or self-report to be 45-60 minutes. second phase of the study, a subset of telephone survey participants will take part in a focus group discussion that will explore their perceptions of barriers for delivery of post-treatment medical and psychosocial follow-up care.
16308146|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 5 microgram per kilogram (mcg/kg) moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308147|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308148|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308149|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308150|NCT00586924|Drug|CAT 8015 (Moxetumomab Pasudotox)|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308151|NCT00586924|Drug|Moxetumomab Pasudotox (CAT 8015)|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
16308152|NCT00586911|Drug|Cystadane|Betaine 20 mg a day or identical placebo for 1 year.
16308153|NCT00586911|Drug|Identical Placebo|Placebo
16308154|NCT00586898|Drug|GnRH|leuprolide and goserelin are gonadotropin-releasing hormone analogues
16308155|NCT00586898|Drug|Ketoconazole|An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
16308156|NCT00586898|Drug|Bicalutamide|A pure nonsteroidal antiandrogen
16308157|NCT00586898|Drug|Testosterone transdermal gel|an androgenic anabolic steroid
16308158|NCT00586898|Drug|Estrogen transdermal patch|Estradiol is the primary and most potent estrogen
16308159|NCT00586885|Drug|L-alanine|6g of L-alanine (powder)once per day for the first month, twice per day for the second month, then three times per day from the third month for 10 months.
16308160|NCT00586859|Device|NDO Full-thickness Plicator|The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.
16308161|NCT00586846|Drug|Cisplatin|Cisplatin 120 mg/m^2
16308162|NCT00586846|Drug|Doxorubicin|75mg/m^2
16308163|NCT00586846|Drug|Methotrexate|Methotrexate 12g/m^2
16308164|NCT00586833|Procedure|O2 consumption max bike test|Single visit exercise study
16308201|NCT00586547|Biological|T-Cell Infusion Dose Level 2|(1 x 10^5 T cells/Kg)
16308166|NCT00586820|Drug|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
16308167|NCT00586807|Other|Stable amino acid isotopes|Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
16308168|NCT00586794|Drug|Sildenafil|3x per day 20 mg TID
16308169|NCT00586794|Drug|Placebo|3x per day, 20 mg TID
16308170|NCT00586781|Device|Scandinavian Total Ankle Replacement (STAR)|The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.
16308171|NCT00586755|Procedure|Intensive Induction-BMT|Patients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2 intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, subjects have not had progression of disease as noted on physical exam or radiographic scans, they will proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support. Following count recovery, rituximab will be used for 8 total doses as consolidation therapy. Involved field irradiation may be given post-transplant to those with localized bulky disease as well.
16308172|NCT00586742|Procedure|labral repair|labral repair with suture anchors
16308173|NCT00586742|Procedure|biceps tenodesis|biceps tenodesis with suture anchor
16308174|NCT00586742|Procedure|diagnostic arthroscopy|diagnostic arthroscopy
16308175|NCT00586729|Device|Vashe|Antimicrobial irrigant
16308176|NCT00586729|Drug|Mafenide acetate|Antimicrobial solution
16308177|NCT00586716|Drug|intravenous immune globulin|0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
16308178|NCT00586703|Device|NK-CD56|NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
16308179|NCT00586690|Device|NK Cell infusion using CD56 monoclonal antibody|The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
16308180|NCT00586690|Procedure|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
16308181|NCT00586677|Behavioral|Parent-Child Interaction Therapy|Sixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills.
16308182|NCT00586677|Behavioral|Health and Safety|Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.
16308183|NCT00586677|Behavioral|Early Relationships|Sixteen one-hour sessions for children age 0-2 provided in-home.
16308184|NCT00586664|Drug|Bepreve (bepotastine besilate ophthalmic solution) 1.5%|sterile ophthalmic solution
16308185|NCT00586664|Drug|placebo comparator|sterile ophthalmic solution
16308186|NCT00586664|Drug|Bepotastine Besilate Ophthalmic Solution 1.0%|sterile ophthalmic solution
16308187|NCT00586651|Drug|lestaurtinib|60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
16308188|NCT00586638|Behavioral|Video game based training|36 one-hour sessions over 12 weeks
16308189|NCT00586625|Drug|Bepreve|One drop, both eyes, twice a day
16308190|NCT00586625|Drug|Placebo|One drop, both eyes, twice a day
16308191|NCT00586612|Biological|Menitorix™|Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
16308192|NCT00586612|Biological|Infanrix™ penta|Intramuscular injection, 3 doses in the primary study
16308193|NCT00586612|Biological|Prevenar™|Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
16308194|NCT00586612|Biological|Infanrix™ IPV|Intramuscular injection, 1 dose in the Booster study.
16308195|NCT00586599|Other|measurement of inflammatory markers|measuring inflammatory markers and comparing to controls.
16308196|NCT00586586|Behavioral|Cognitive behavioural therapy|The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
16308197|NCT00586573|Drug|memantine hydrochloride|tablet, 5-20 mg, twice daily, by mouth, 12 weeks
16308198|NCT00586560|Drug|Kareniticin and cyclophosphamide|"An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle).
~Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity."
16308199|NCT00586547|Biological|T-Cell Infusion Dose Level -1|(1 x 10^3 T cells/Kg)
16308200|NCT00586547|Biological|T-Cell Infusion Dose Level 1|(1 x 10^4 T cells/Kg)
16308203|NCT00586547|Biological|T-Cell Infusion- Dose Level 4|(5 x 10^6 T cells/Kg)
16308204|NCT00586534|Behavioral|I/GDC + VR/CER|NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions.
16308205|NCT00586534|Behavioral|I/GDC|NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment
16308206|NCT00586521|Drug|Kogenate (BAY14-2222)|One group two treatment schedules, first on-demand then switch to prophylaxis
16308207|NCT00586508|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
16308208|NCT00586508|Drug|bevacizumab|10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).
16308209|NCT00586508|Drug|Enzyme-inducing antiepileptic drugs (EIAED)|Administered orally
16308210|NCT00586508|Drug|Non-enzyme inducing antiepileptic drugs (NEIAED)|Administered orally
16308211|NCT00586495|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
16308212|NCT00586482|Drug|Nicotine Lozenge|Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
16308213|NCT00586482|Drug|Placebo Lozenge|Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention.
16308214|NCT00586482|Behavioral|Abstinence Advisement|A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
16308215|NCT00586469|Biological|Fluviral|One dose, Intramuscular injection
16308216|NCT00586443|Drug|bevacizumab, everolimus, panitumumab|"Cohort # subjects Bevacizumab Everolimus Panitumumab
~3 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 3.6 mg/kg IV Q2 weeks
~2 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 4.8 mg/kg IV Q2 weeks
~1 3-6 10 mg/kg IV Q2 weeks 5 mg PO QD 4.8 mg/kg IV Q2 weeks
~3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 4.8 mg/kg IV Q2 weeks
~3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 6 mg/kg IV Q2 weeks 3a 10 RPTD* RPTD* RPTD* 3b 10 RPTD** RPTD** RPTD**
~Panitumumab and RAD001 started on Day 1, bevacizumab started on Day 15. **Bevacizumab and RAD001 started on Day 1, panitumumab started on Day 15."
16308217|NCT00586430|Drug|lorazepam|single 2 mg dose of lorazepam
16308218|NCT00586430|Drug|placebo|single dose of placebo
16308219|NCT00586417|Other|punch biopsy|skin biopsies
16308220|NCT00586391|Genetic|CD19CAR-28-zeta T cells|"Intravenous injection
~Dose Level 1:
~CD19CAR-28zeta - 2x10^7 cells/m^2
~Dose Level 2:
~CD19CAR-28zeta - 1 x10^8 cells/m^2
~Dose Level 3:
~CD19CAR-28zeta - 2x10^8 cells/m^2"
16308221|NCT00586391|Drug|Ipilimumab|For patients with intermediate or low grade leukemia/lymphoma, patients may receive ipilimumab once during the week 2 visit after the T cell infusion.
16308222|NCT00586378|Device|Ovatio DR and Ovatio VR|implantable cardioverter defibrillator
16308223|NCT00586365|Drug|Naproxen|500 mg Naproxen twice a day for two weeks
16308224|NCT00586352|Other|stable isotope infusions|Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
16308225|NCT00586339|Biological|Cervarix|Intramuscular injection, 3 doses
16308226|NCT00586339|Biological|Placebo Control|Intramuscular injection, 3 doses
16308227|NCT00586326|Device|MammoSite Radiation Therapy System|The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
16308228|NCT00586313|Device|Tru-cut biopsy|Tru-cut biopsy may be an alternative to percutaneous and transjugular liver biopsy.
16308229|NCT00586313|Procedure|Tru-cut|Tru-cut may be an alternative to percutaneous and transjugular liver biopsy.
16308230|NCT00586300|Other|Physical training program|The physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis.
16308231|NCT00586300|Behavioral|Self-management training program|The self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry.
16308232|NCT00586300|Other|Physical training and self-management training programs|"This multidimensional intervention will combine both the physical training and self-management training programs described for Groups 1 and 2."
16308233|NCT00586287|Other|Algorithm for phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm A published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
16308234|NCT00586287|Other|algorithm for phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm B published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
16308235|NCT00586287|Drug|Phenprocoumon|Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
16308236|NCT00586274|Procedure|CD34 selected haploidentical PBSCT|Infusion of CD34 selected haploidentical PBSCT
16308237|NCT00586274|Drug|Fludarabine|day -8 through day -4 Fludarabine 30 mg/m^2
16308238|NCT00586274|Biological|T cell infusion|"At least 30 days after the stem cell infusion, patients will be dosed with T cells. This study will begin with a dose of T cells known not to cause GvHD even in haploidentical recipients, even when the T cells administered have not first been allodepleted. Dose escalation will follow a traditional up and down method, but as results become available they will be used to determine subsequent dose levels by the continual reassessment method. Initially, 2 patients will be entered beginning at dose level 1. Each and every patient will receive up to three additional injections of T cells at the same dose, at monthly intervals, provided there is no evidence of grade 2 or higher GVHD, until total T cell numbers are > 1000/ul.
~Dose level -1 (1 x 10^3 T cells/Kg); Dose level 1 (1 x 10^4 T cells/Kg); Dose level 2 (1 x 10^5 T cells/Kg); Dose level 3 (1 x 10^6 T cells/Kg); Dose level 4 (5 x 10^6 T cells/Kg)"
16308239|NCT00586274|Biological|Campath 1h|10 mg iv over 4 hours day-8 through day-6
16308240|NCT00586274|Biological|anti-CD45|anti-CD45 400 ug/kg over 6 hours day -5 through day -2
16308241|NCT00586261|Drug|Pioglitazone|Pioglitazone 30 mg daily for 6 months
16308242|NCT00586261|Drug|Placebo|Placebo 30 mg daily for 6 months
16308243|NCT00586261|Drug|Nitroglycerin|0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.
16308244|NCT00586222|Dietary Supplement|Omega-3 Fatty Acid|600 mg of eicosapentaenoic acid, 340 g of docosahexanoic acid, and 96 mg gama-linoleic acid for 12 weeks.
16308245|NCT00586222|Other|Placebo|placebo pill of the same size, color, and shape as the dietary supplement.
16308246|NCT00586209|Drug|L-Glutamine|L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)
16308247|NCT00586209|Drug|Placebo|Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine
16308248|NCT00586196|Drug|donepezil|5 mg each day for 30 days
16308249|NCT00586196|Drug|Placebo|Encapsulated cornstarch One capsule daily for 30 days
16308250|NCT00586183|Procedure|PET scan|The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction.
16308251|NCT00586170|Device|EBI Bone Healing System|10 hours of treatment per day for up to 24 weeks
16308252|NCT00586170|Device|Placebo Device|10 hours of treatment per day for up to 24 weeks
16308253|NCT00586170|Procedure|Surgery|Open Reduction and Internal Fixation of the nonunion site
16308254|NCT00586157|Drug|Methylphenidate Transdermal System|Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
16308255|NCT00586157|Drug|Placebo|Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
16308256|NCT00586131|Drug|ammonium chloride or sodium citrate/citric acid|Dose dictated by changes in pH
16308257|NCT00586131|Drug|Sodium citrate/citratic acid|dictated by pH
16308258|NCT00586118|Drug|Sevoflurane|Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU
16308259|NCT00586118|Drug|Propofol|Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
16308260|NCT00586105|Drug|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
16308261|NCT00586092|Drug|bevacizumab, ABT-510|"Stage 1 (Cohorts -1, 2, 2, 3) ABT-510: 25, 50, 50, 100 mg SC BID*, bevacizumab: 5, 5, 10, 10 mg/kg IV every 14 days*
~Stage 2 (RPTD) ABT-510: X mg SC BID**, bevacizumab: Y mg/kg IV every 14 days**
~Stage I is the dose escalation stage. Stage II will include an additional 20 patients (10 patients in each group) enrolled at the RPTD in two different schedules to better assess safety and biomarker correlates.
~*Both agents begin on Day 1 of Cycle 1.
~**At the RPTD, ½ the patients will begin ABT-510 (Dose X) on Day 1 and bevacizumab (Dose Y) on Day 15 and the other ½ of the patients will begin bevacizumab on Day 1 and ABT-510 on Day 15. This will allow for a collection of some preliminary data of wound angiogenesis effects of ABT-510 alone versus the combination and bevacizumab alone versus the combination."
16308262|NCT00586079|Procedure|Deep brain stimulation surgery.|Deep brain stimulation surgery.
16308263|NCT00586066|Drug|Memantine|Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d.
16308264|NCT00586066|Drug|Placebo|Inactive comparator. Placebo-matching memantine tablet.
16308265|NCT00586040|Procedure|tissue bonding|application of rose bengal and treatment with green light
16308266|NCT00586040|Procedure|sutures|interrupted superficial sutures
16308267|NCT00586014|Procedure|High-Dose Sequential Chemotherapy followed by ASCT|Patient will receive Cyclophosphamide(4 g/m2 over 2 hours) and blood progenitor cell collection (day -49). G-CSF (10 mcg/kg/d) will be administered SQ. A six hour leukapheresis will be performed,cells will undergo CD34+ cell selection, patients will receive high dose VP-16 (Etopophos)(day -28)(2 g/m2 over 4 hours)and G-CSF (5 mcg/kg/d) will be administered SQ two days following VP-16. The an IV of sulfamethoxazole-trimethoprim 1 ampule BID for 5 days (Day -5). BCNU 500 mg/m2 IV over 2 hours (Day -4). Melphalan (Day -2) will be administered IV (200 mg/m2 over 20 minutes). The frozen peripheral blood mononuclear cells will be transfused on Day 0. Day +1: G-CSF 5 mcg/kg/d SQ for 3 days.
16308268|NCT00586001|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|Cognitive-behavioral treatment in development for emotional disorders
16308269|NCT00585988|Device|Hip Resurfacing System|This arm will utilize a hip resurfacing system.
16308270|NCT00585988|Device|M2a-Magnum™ Large Metal Articulation|This arm will utilize the M2a-Magnum™ implant system.
16308271|NCT00585975|Drug|bromfenac ophthalmic solution|sterile opthalmic solution
16308272|NCT00585962|Radiation|Proton Beam Radiation|Once a day, 5 days a week (Monday-Friday), for 8 weeks.
16308273|NCT00585949|Procedure|Percutaneous Coronary Angioplasty|This is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened.
16308274|NCT00585949|Procedure|Angiography|Angiography is an imaging technique to see coronary blood vessels.
16308275|NCT00585923|Device|Fixed hole C-Tek™ Plate|Fixed hole C-Tek™ Plate
16308276|NCT00585923|Device|Slotted hole C-Tek™ Plate|Slotted hole C-Tek™ Plate
16308277|NCT00585910|Drug|Atomoxetine and OROS Methylphenidate|Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
16308278|NCT00585897|Behavioral|discontinuation of sugar sweetened beverages|Individual sessions which utilize motivational interviewing to assist participants to eliminate sugar sweetened beverages from their diet.
16308279|NCT00585871|Drug|clonidine|0.1 mg tid
16308280|NCT00585871|Drug|metoprolol|25 mg tid
16308281|NCT00585845|Biological|CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin|2-hour IV infusion once every 21 days, up to 4 doses. Doses from 1x10^8 cfu to 1x10^10 cfu.
16308282|NCT00585832|Behavioral|DASH-4-Teens|24-week behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy foods and that is low in fat and sodium
16308283|NCT00585832|Other|Routine Care|individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.
16308284|NCT00585819|Procedure|reproduce breathing cycle utilizing spirometry|reproduce breathing cycle utilizing spirometry
16308285|NCT00585819|Procedure|Freebreathing in Body fix mold|Freebreathing in Body fix mold
16308286|NCT00585793|Drug|NRTI/NNRTI/ Kaletra|Fixed dose and cild formulation Kaletra
16308287|NCT00585780|Drug|Prazosin Tablet|Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.The titration schedule was as follows: 1 mg dose at bedtime for 2 nights, followed by a 1mg dose morning and night (8 AM/8 PM) on day 3, then 2 mg dose t.i.d., on days 4-6, 3 mg dose (2 pills each) morning and afternoon, and 4 mg dose (2 pills) at night for days 7-9, increased to 4 mg dosing t.i.d. on days 10-13, and from day 14 through week 11, 5 mg (1 pill) each in the morning and afternoon, and 6 mg for the night (2 pills) dose. This was followed by a 5-day taper in week 12. Patients were initiated on study medication upon presenting with a negative breathalyzer without any minimum pre-treatment alcohol abstinence period prior to medication initiation.
16308288|NCT00585780|Drug|Placebo Tablet|Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
16308289|NCT00585754|Drug|Guanfacine|1.5mg BID
16308290|NCT00585754|Drug|Placebo|placebo
16308291|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
16308292|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
16308293|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
16308294|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
16308295|NCT00585741|Procedure|Imaging with 18F-FLT PET|Imaging with 18F-FLT PET
16308296|NCT00585728|Procedure|CT Virtual Proctoscopy (CTVP)|CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.
16308297|NCT00585715|Device|1064 nm Nd:YAG laser|3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms
16308298|NCT00585689|Drug|ABI-007|ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle.
16308299|NCT00585689|Drug|Carboplatin|Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle.
16308300|NCT00585689|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.
16308301|NCT00585689|Procedure|Radical Cystectomy|
16308302|NCT00585650|Biological|Etanercept|Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.
16308303|NCT00585650|Other|Placebo injections|Placebo injections twice weekly for 12 weeks.
16308304|NCT00585637|Drug|Vitamin D|Taken orally every day for three months
16308305|NCT00585637|Dietary Supplement|Placebo|Placebo pill taken once daily for 3 month
16308306|NCT00585624|Dietary Supplement|Impact Advanced Recovery|Nutritional supplement
16308307|NCT00585624|Dietary Supplement|No supplement|No supplement
16308308|NCT00585611|Drug|Atorvastatin|Atorvastatin - 40 mg orally daily for 6 months
16308309|NCT00585611|Other|placebo|placebo
16308310|NCT00585598|Other|replacing supralaryngeal airway with ET tube|changing tube in trauma bay
16308311|NCT00585585|Drug|betahistine dihydrochloride|oral, 50-300 mg, daily
16308312|NCT00585559|Drug|Placebos for acetaminophen and N-acetylcysteine|Placebos for acetaminophen and N-acetylcysteine
16308313|NCT00585559|Drug|APAP 1 gm every 6 hours and N-acetylcysteine placebo|Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo
16308314|NCT00585559|Drug|NAC IV infusion at 0.5 gm hourly and APAP placebo|N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo
16308315|NCT00585559|Drug|APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly|Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
16308316|NCT00585559|Drug|APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly|Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
16308317|NCT00585546|Drug|clenbuterol|Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
16308318|NCT00585533|Drug|Erlotinib (Tarceva)|Erlotinib
16308319|NCT00585520|Drug|Progesterone|200mg BID for 5 days
16308320|NCT00585520|Drug|Placebo|Placebo
16308321|NCT00585507|Drug|Fulvestrant|500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
16308322|NCT00585481|Procedure|Samples collection for viral diagnosis|"At Enrollment and Termination Visits all subjects will have phlebotomy performed for RSV antibody levels (3 mL of blood).
~Subjects diagnosed with an LRTI during the study will have a nasopharyngeal lavage (NPL) for viral diagnosis. Phlebotomy for antibody levels will be performed if the current episode represents the first LRTI since study enrollment."
16308421|NCT00584688|Drug|quetiapine|quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.
16308323|NCT00585481|Procedure|Lung Function Analysis|Subjects enrolled in one study site (located in Porto Alegre city) will perform Lung Function Analysis. First measurement will be performed up to Visit 6 and repeated at Termination Visit. Measurements collected in the first analysis will include respiratory compliance and resistance by passive deflation pressure - volume curve, lung volumes by gas dilution method (washout with SF6), lung clearance index with SF6, and maximal flows (rapid thoracic compression from raised volumes).
16308324|NCT00585468|Drug|Myfortic|Myfortic 720 mg orally twice daily
16308325|NCT00585455|Drug|sertraline|open label 25-50 mg daily as tolerated
16308326|NCT00585442|Drug|calcitriol|1.0 mcg daily
16308327|NCT00585442|Drug|Placebo|Placebo
16308328|NCT00585416|Drug|CGC-11047|CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
16308329|NCT00585390|Dietary Supplement|Omega-3 Fatty Acids|"Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
~Docosahexaenoic acid fish oil concentrate at 1.6 grams"
16308330|NCT00585390|Other|Olive oil placebo|Olive oil capsules, 8 capsules per day
16308331|NCT00585390|Dietary Supplement|EPA fish oil concentrate; DHA fish oil concentrate|3.2 grams for EPA 1.6 grams for DHA
16308332|NCT00585390|Drug|Placebo|Olive oil capsule
16308333|NCT00585377|Drug|Bevacizumab and Erlotinib|Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
16308334|NCT00585351|Drug|Ranitidine|50 mg single dose injection of Ranitidine
16308335|NCT00585351|Drug|Placebo|50 mg single dose injection of normal saline (placebo)
16308336|NCT00585351|Other|Advanced notification|Advanced notification of study via faxed consent to local Emergency Room (ER)
16308337|NCT00585351|Other|No advanced notification|No advanced notification of study via faxed consent to local Emergency Room (ER)
16308338|NCT00585338|Device|Tandem 532/1064 nm Laser|Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
16308339|NCT00585325|Drug|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
16308340|NCT00585325|Other|Placebo (0.9% Normal Saline)|.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
16308341|NCT00585312|Drug|Celecoxib|celecoxib, 16 mg/kg/day, for 5 years
16308342|NCT00585312|Drug|Placebo|Masked, placebo comparator
16308343|NCT00585299|Other|Low-fat diet|20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks
16308344|NCT00585299|Other|Traditional diet|Traditional low-fat diet with dietitian follow-up in 16 weeks
16308345|NCT00585286|Device|10,600 nm fractional carbon dioxide laser system|1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
16308346|NCT00585260|Drug|mannitol|indirect mannitol challenge
16308347|NCT00585247|Drug|Imiquimod|Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
16308348|NCT00585247|Other|Placebo|Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
16308349|NCT00585234|Other|Digital Photography|Digital Photography
16308350|NCT00585221|Drug|Peginterferon-alpha 2b (PegIFNa2b);|Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible.
16308351|NCT00585221|Drug|Imatinib|Continue imatinib until progression.
16308352|NCT00585208|Drug|Ramelteon|Ramelteon 8mg daily
16308353|NCT00585208|Drug|Placebo|matching placebo for ramelteon 8mg daily
16308354|NCT00585195|Drug|PF-02341066|Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).
16308355|NCT00585195|Drug|Rifampin|600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
16308356|NCT00585195|Drug|Itraconazole|Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
16308357|NCT00585182|Drug|Enoxaparin 0.5 mg/kg once daily|Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
16308358|NCT00585169|Drug|Memantine Hydrochloride|10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
16308359|NCT00585156|Drug|Celecoxib|Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.
16308360|NCT00585143|Drug|ABT-335|45 mg once daily for 10 consecutive days
16308361|NCT00585143|Drug|Rosuvastatin|10 mg once daily for 10 days
16308362|NCT00585117|Procedure|PET-imaging with CuATSM|imaging with CuATSM
16308363|NCT00585117|Procedure|PET Imaging|Imaging with CuATSM
16308364|NCT00585117|Procedure|PET CuATSM|Imaging with CuATSM
16308365|NCT00585117|Procedure|PET imaging|imaging with CuATSM
16308366|NCT00585117|Procedure|PET imaging with CuATSM|Imaging with CuATSM
16308367|NCT00585117|Procedure|PET imaging with CuATSM|Imaging with CuATSM
16308368|NCT00585104|Drug|levosimendan|10-minute infusion
16308369|NCT00585091|Drug|phenylephrine|All patients undergo repeated phenylephrine infusions during standard up-titration and maintenance of carvedilol treatment.
16308370|NCT00585078|Drug|Capecitabine|
16308371|NCT00585078|Drug|Oxaliplatin|
16308372|NCT00585065|Other|Cardiac Resynchronization Therapy|Cardiac Resynchronization Therapy
16308373|NCT00585052|Drug|Paclitaxel|Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
16308374|NCT00585052|Drug|Lovastatin|Lovastatin, 80 mg, po, daily will be self-administered by the subject.
16308375|NCT00585039|Drug|xopenex|will receive xopenex rather than albuterol to treat acute exacerbation
16308376|NCT00585026|Device|D-28 bifocal lenses and frame|
16308377|NCT00585026|Device|Progressive addition computer lenses and frame|
16308456|NCT00584298|Drug|SMS995|
16308457|NCT00584298|Drug|Placebo|
16308378|NCT00585013|Drug|Nitric Oxide|Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
16308379|NCT00585000|Drug|CP-675,206|15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.
16308380|NCT00584987|Drug|Fluticasone furoate|2 puffs of each nasal spray in each nostril in the pm
16308381|NCT00584987|Drug|Placebo Fluticasone furoate|2 puffs of each nasal spray in each nostril in the pm
16308382|NCT00584987|Drug|Oxymetazoline|2 puffs of each nasal spray in each nostril in the pm
16308383|NCT00584987|Drug|Placebo Oxymetazoline|2 puffs of each nasal spray in each nostril in the pm
16308384|NCT00584974|Drug|SEP-225289|0.5 mg SEP-225289
16308385|NCT00584974|Drug|SEP-225289|2.0 mg SEP-225289
16308386|NCT00584974|Drug|Venlafaxine|150 mg Venlafaxine
16308387|NCT00584974|Drug|placebo|Placebo
16308388|NCT00584961|Other|non-interventional|non-interventional
16308389|NCT00584948|Drug|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
16308390|NCT00584948|Drug|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
16308391|NCT00584935|Drug|Rituximab|The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
16308392|NCT00584922|Procedure|Endoscopy in group I (all patients)|Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
16308393|NCT00584909|Drug|Paclitaxel and carboplatin combination|Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR).
16308394|NCT00584896|Drug|PB127 for Injectable Suspension|0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
16308395|NCT00584883|Drug|ABT 510|ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.
16308396|NCT00584870|Drug|Naproxen|Oral naproxen 500 mg twice daily for Weeks 1-12.
16308397|NCT00584870|Drug|Placebo|Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
16308398|NCT00584870|Drug|PF-04383119 (RN624)|Single IV infusion of 200 micrograms/kg RN624 on Day 1
16308399|NCT00584857|Drug|Paclitaxel ,Carboplatin , Megesterol Acetate|Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.
16308400|NCT00584844|Biological|Live F tularensis Vaccine|Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).
16308401|NCT00584831|Device|senofilcon A|toric contact lens
16308402|NCT00584831|Device|balafilcon A|toric contact lens
16308403|NCT00584831|Device|omafilcon A|toric contact lens
16308404|NCT00584831|Device|lotrafilcon B|toric contact lens
16308405|NCT00584818|Drug|PB127 for Injectable Suspension|"Stages 1 & 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.
~Stage 3 - will utilize infusion rate and dose established in Stages 1 & 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions."
16308406|NCT00584805|Biological|Inactivated, Dried, TSI-GSD 104, EEE|Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
16308407|NCT00584779|Drug|Gabapentin|CLcr:14-5 mL/min
16308408|NCT00584779|Drug|Gabapentin|CLcr: 29-15 mL/min
16308409|NCT00584779|Drug|Gabapentin|Hemodialysis
16308410|NCT00584779|Drug|Gabapentin|CLcr: 29-30 mL/min
16308411|NCT00584766|Procedure|High-dose chemotherapy|Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days
16308412|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
16308413|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
16308414|NCT00584753|Radiation|Positron emission tomography and computed tomography|Positron emission tomography and computed tomography
16308415|NCT00584740|Drug|AIN457|10 mg/kg
16308416|NCT00584740|Drug|Placebo|Matching placebo to AIN457
16308417|NCT00584727|Device|senofilcon A toric contact lens|contact lens
16308418|NCT00584727|Device|alphafilcon A toric|contact lens
16308419|NCT00584727|Device|etafilcon A sphere|contact lens
16308420|NCT00584701|Drug|Risperidone|Dose will start at 0.5 mg and may be increased throughout the course of the study if no adverse events occur
16308458|NCT00584259|Other|Coffee|3 cups of coffee over a 24 hour period
16308422|NCT00584675|Device|Dx-pH Measurement Probe|Dx-pH Measurement Probe measures gaseous pH values in the nasopharynx and oropharynx over a period of 24 hours.
16308423|NCT00584662|Drug|Oxymetazoline Hydrochloride|Oxymetazoline Hydrochloride TWO SPRAYS BID
16308424|NCT00584649|Procedure|electrophysiology study and radiofrequency ablation|stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart
16308425|NCT00584636|Drug|pulmicort respules|pulmicort respules 0.5 mg twice a day for 28 days versus placebo
16308426|NCT00584610|Device|Levonorgestrel-containing IUD (Mirena®)|Levonorgestrel-containing intrauterine device insertion
16308427|NCT00584610|Device|Copper-containing IUD (Paraguard®)|Copper-containing intrauterine device insertion
16308428|NCT00584597|Drug|Saline|Saline Control
16308429|NCT00584597|Drug|Traumeel S|Traumeel S 1 mL
16308430|NCT00584597|Drug|Traumeel S|Traumeel S 2mL
16308431|NCT00584597|Drug|Traumeel S|Traumeel S 3mL
16308432|NCT00584584|Drug|QAX576|
16308433|NCT00584584|Drug|Placebo|
16308434|NCT00584571|Procedure|Sensory Adaptation Training|This study will last for approximately 3 months and will include 4-6 clinic visits with each visit lasting 2 hours every week or every 2 weeks. At the beginning of each visit we will ask you about your health status and level of satisfaction of your bowel habits. We will then place the pencil-thick probe and balloon inside your rectum and attach it to the barostat device and a computer. We will increase and decrease the volumes of the balloon until the most pressure you can tolerate or a certain level of pressure as measured by the machine is reached, whichever occurs first. You will continue to keep stool diaries and pain diaries for 7 days before and after each visit.
16308435|NCT00584571|Drug|Escitalopram Therapy|Escitalopram; 10 mg every day, orally.
16308436|NCT00584558|Procedure|Catheter Ablation|Catheter Ablation of arrhythmias
16308437|NCT00584532|Drug|Placebo|10 Placebo Capsules taken orally every day.
16308438|NCT00584532|Drug|GCP - Genistein Combined Polysaccharide|Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
16308439|NCT00584519|Other|non-interventional|non-interventional
16308440|NCT00584493|Drug|CP-675,206|"This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma
~Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206."
16308441|NCT00584480|Other|Hyperbaric Oxygen Treatment (HBOT)|1.5 ATA at 100% Oxygen of HBOT
16308442|NCT00584454|Biological|Q Fever Vaccine (NDBR 105|Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study.
16308443|NCT00584428|Procedure|High-Dose Chemo with Autologous BMT|Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70
16308444|NCT00584415|Device|GP ablation + PV isolation|All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
16308445|NCT00584402|Drug|perflutren lipid microspheres|perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
16308446|NCT00584389|Drug|rimonabant|20mg/d (oral) once daily for 12 weeks
16308447|NCT00584389|Behavioral|Dietary intervention|Dietary intervention to match weight loss in group 1. The energy prescription will be based on the estimate of the energy deficit estimated from the weight loss in group one. For example a weight loss of 5kg over 12 weeks equates to an approximate energy deficit of 30,000 kcal or a daily energy reduction of approximately 357 kcal. If this is achieved in group 1 the daily energy target for subjects in group 2 will be daily energy expenditure minus 357 kcal.For the subjects randomised to the dietary intervention group there will be a delay until group 1 subjects have completed the study.
16308448|NCT00584376|Drug|Pregabalin|Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
16308449|NCT00584376|Drug|Placebo|Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
16308450|NCT00584350|Other|Hydratation according LVEDP + NaHCO3|"Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
~At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours."
16308451|NCT00584350|Other|normal saline|hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
16308452|NCT00584350|Other|Sodium bicarbonate|hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
16308453|NCT00584324|Combination Product|BIS 40|"Mini-mental state exam: For subjects > 60, this exam will be administered pre-operatively.
~Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
~Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
~Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
~Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure."
16308454|NCT00584324|Combination Product|BIS 60|"Mini-mental state exam: For subjects > 60, this exam will be administered pre-operatively.
~Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
~Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
~Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
~Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure."
16308455|NCT00584311|Other|MRI and Ultrasound|MRI and US of the joint
16308459|NCT00584246|Drug|Pregabalin (Lyrica)|50 - 150 mg po qhs for 2 months
16308460|NCT00584246|Drug|Placebo|50 - 150 mg po qhs for 2 months
16308461|NCT00584233|Device|computed tomography|Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
16308462|NCT00584220|Device|senofilcon A toric|contact lens
16308463|NCT00584220|Device|alphafilcon A toric|contact lens
16308464|NCT00584207|Procedure|radiofrequency ablation|Intraoperative RFA of uterine fibroids
16308465|NCT00584194|Biological|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
16308466|NCT00584168|Drug|Dexamethasone|They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.
16308467|NCT00584168|Drug|Placebo|They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.
16308468|NCT00584155|Drug|Normal Saline and 0.3% ofloxacin|The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear and are only to be used in the designated ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
16308469|NCT00584155|Drug|Lactated Ringer's with 0.03% Ofloxacin|The patient will be instructed to place one dropper full of solution in the external auditory canal. The bottle will be marked right or left ear. The drops will be administered at the start time, 30 minutes after chemotherapy starts and hourly for 4 hours after infusion.
16308470|NCT00584142|Behavioral|Mindfulness-Based Stress Reduction|MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program.
16308471|NCT00584129|Other|Pre-treatment swallowing exercises|Swallowing exercises will be started pre-treatment with radiation.
16308472|NCT00584129|Other|Post-treatment swallowing exercises.|Patients to start swallowing exercises after completion of radiation therapy.
16308473|NCT00584103|Device|Alpha P Control|Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
16308474|NCT00584103|Device|Beta P Experimental|Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
16308475|NCT00584090|Drug|Solifenacin Succinate (VESIcare)|5 - 10 mg po qd for 1 month
16308476|NCT00584090|Drug|Placebo|Placebo equivalent of 5-10 mg po qd for 1 month
16308477|NCT00584064|Device|Device closure with the AMPLATZER PFO Occluder|Device closure with the AMPLATZER PFO Occluder
16308478|NCT00584038|Behavioral|educational instruction and phone follow-up|Educational instruction and phone follow-up.
16308479|NCT00584038|Behavioral|educational instruction in clinic|Educational instruction in clinic.
16308480|NCT00584025|Drug|levetiracetam|100 - 500mg IV q 15 min
16308481|NCT00584025|Drug|Placebo|Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min
16308482|NCT00584012|Drug|Lovastatin|Given PO
16308483|NCT00584012|Drug|Docetaxel|Given IV
16308484|NCT00583999|Other|no interventions, only regular blood-draw|No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)
16308485|NCT00583986|Drug|Levalbuterol HFA MDI with top mounted actuation indicator|Levalbuterol HFA MDA with top mounted actuation indicator
16308486|NCT00583947|Drug|arformoterol|Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
16308487|NCT00583947|Drug|levalbuterol|Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
16308488|NCT00583908|Device|senofilcon A|toric contact lens
16308489|NCT00583908|Device|balafilcon A toric|toric contact lens
16308490|NCT00583908|Device|lotrafilcon B toric|toric contact lens
16308491|NCT00583908|Device|omafilcon A|toric contact lens
16308492|NCT00583895|Drug|10% ImCOOH cream|Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15.
16308493|NCT00583895|Drug|Placebo|Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15.
16308494|NCT00583882|Other|Routine change of central venous catheters|Changeing CVCs on a regular basis to decrease infection rate.
16308495|NCT00583869|Drug|Placebo|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive a placebo PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (placebo PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
16308535|NCT00583622|Procedure|Stem Cell Transplant|"Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest
~Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen"
16308536|NCT00583609|Drug|PEG3350|PEG3350
16309095|NCT00578682|Biological|MEDI-557|Single IV dose of 3 mg/kg
16308496|NCT00583869|Drug|Pregabalin|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 75mg PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (pregabalin 75mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
16308497|NCT00583869|Drug|Pregabalin|"Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 150mg PO BID beginning on the day of surgery until discharge.
~Upon discharge, the patient will be given study medication (pregabalin 150mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient."
16308498|NCT00583843|Procedure|Ultrasound|Ultrasound weekly during initial fields of radiation, and daily during the boost phase.
16308499|NCT00583830|Biological|Mapatumumab|30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
16308500|NCT00583830|Biological|Mapatumumab|10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
16308501|NCT00583830|Drug|Paclitaxel|200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
16308502|NCT00583830|Drug|Carboplatin|AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
16308503|NCT00583817|Device|Endovascular stent-graft implantation|Endovascular repair of aorta
16308504|NCT00583804|Device|IST-12|Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
16308505|NCT00583791|Device|Device closure with the AMPLATZER Muscular VSD Occluder|Device: AMPLATZER Muscular VSD Occluder
16308506|NCT00583778|Drug|ipratropium|0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
16308507|NCT00583765|Drug|Regional citrate anticoagulation|Continuous venovenous hemodiafiltration with regional anticoagulation using dilute trisodium citrate. This requires the use of a continuous renal replacement therapy (CRRT) machine in venovenous hemodiafiltration mode. Anticoagulation and buffer are provided by the use of a dilute solution of trisodium citrate in the replacement fluid which is infused in a predilution mode. Standard bicarbonate containing dialysate is used.
16308508|NCT00583752|Biological|Adenovirus/PSA Vaccine|1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
16308509|NCT00583739|Behavioral|Yoga|Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.
16308510|NCT00583726|Behavioral|motivational interviewing|telephone counseling
16308511|NCT00583726|Behavioral|written materials only|dietary guidance materials and pedometers
16308512|NCT00583713|Drug|BLI-800|BLI-800 oral solution (two doses)
16308513|NCT00583700|Drug|Pentoxifylline|Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
16308514|NCT00583700|Drug|Vitamin E|Vitamin E (Over-the-counter) 400 I.U. once daily
16308515|NCT00583687|Device|Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)|Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.
16308516|NCT00583687|Other|Passive leg raising|Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.
16308517|NCT00583687|Other|Volume challenge / Change of vasoactive drugs or inotropics|Either a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician.
16308518|NCT00583687|Device|Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)|Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.
16308519|NCT00583674|Drug|AMG 386 placebo|AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308520|NCT00583674|Drug|AMG 386 10mg/kg|AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308521|NCT00583674|Drug|AMG 386 3mg/kg|AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308522|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308523|NCT00583674|Drug|Capecitabine|Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308524|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308525|NCT00583674|Drug|Capecitabine|Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308526|NCT00583674|Drug|Cisplatin|Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308527|NCT00583674|Drug|Capecitabine|Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
16308528|NCT00583661|Device|EXCOR Pediatric|Extracorporeal Ventricular Assist Device
16308529|NCT00583648|Other|Urinanlysis|sending a Urine sample to the laboratory for processing
16308530|NCT00583622|Drug|Bevacizumab|5 mg/kg by vein daily over 90 minutes for 2 Days
16308531|NCT00583622|Drug|Carboplatin|333 mg/m^2 by vein over 2 hours for 3 Days
16308532|NCT00583622|Drug|Docetaxel|300 mg/m^2 by vein over 2 hours for 1 Day
16308533|NCT00583622|Drug|Gemcitabine|1,800 mg/m2 by vein over 3 hours for 4 Days
16308534|NCT00583622|Drug|Melphalan|50 mg/m^2 by vein over 15 minutes for 3 Days
16308537|NCT00583596|Device|Device closure with AMPLATZER Duct Occluder|Device closure with AMPLATZER Duct Occluder
16308538|NCT00583596|Other|Objective Performance Criteria|Compare results of device closure to objective performance criteria
16308539|NCT00583583|Device|Device closure with the AMPLATZER Duct Occluder|Device closure with the AMPLATZER Duct Occluder
16308540|NCT00583570|Behavioral|dietary education|dietary education
16308541|NCT00583557|Drug|belimumab|IV 10mg/kg Q28 days
16308542|NCT00583544|Drug|TC-2216|Multiple ascending dose groups will be explored.
16308543|NCT00583531|Drug|AST-120|Oral, 2 grams TID in sachets for 4 weeks
16308544|NCT00583518|Drug|Parathyroid hormone (PTH)|Postmenopausal women with primary osteoporosis
16308545|NCT00583505|Device|Device closure with the AMPLATZER Membranous VSD Occluder|Device closure with the AMPLATZER Membranous VSD Occluder
16308546|NCT00583492|Biological|Ad5-yCD/mutTKSR39rep-ADP|Ad5-yCD/mutTKSR39rep-ADP (1 x 10^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy
16308547|NCT00583492|Radiation|IMRT|40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
16308548|NCT00583479|Other|one injection into the celiac ganglion|one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
16308549|NCT00583479|Other|two injections into the celiac ganglion|two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
16308550|NCT00583466|Drug|Autologous blood injection|Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
16308551|NCT00583466|Drug|Normal saline|Normal saline will be injected under the lesion to create submucosal cushion
16308552|NCT00583466|Drug|HPMC|Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
16308553|NCT00583453|Drug|Celecoxib|"Celecoxib 200 mg capsule
~capsule the night before surgery
~capsules the morning of surgery
~1 capsule the night of surgery
~1 capsule twice daily for 10 days immediately after the surgery"
16308554|NCT00583453|Drug|Placebo|"Placebo capsule
~capsule the night before surgery
~capsules the morning of surgery
~1 capsule the night of surgery
~1 capsule twice daily for 10 days immediately after the surgery"
16308555|NCT00583440|Behavioral|12-step facilitation|12 weekly individual 12-step facilitation sessions
16308556|NCT00583440|Behavioral|Treatment as usual|Usual clinical treatment in a dual diagnosis treatment program
16308557|NCT00583427|Drug|Sulodexide|200 mg per day in an oral gelcap form
16308558|NCT00583414|Device|Endovascular Aneurysm Repair|Endovascular exclusion of aneurysm
16308559|NCT00583401|Device|Device closure with the AMPLATZER PFO Occluder|Device closure with the AMPLATZER PFO Occluder
16308560|NCT00583388|Dietary Supplement|L-arginine|Each subject will be exposed to three treatments, a) 5 g of L-arginine, b) 15 g of L-arginine, and c) placebo, the sequences will be randomly assigned to the 42 volunteers. The washout period between interventions will be from one to two days.L-arginine will be mixed in 60 cc of dextrose-based syrup to blind the taste and color of the L-arginine powder.
16308561|NCT00583388|Device|Ultrasound|Ultrasound from the brachial artery will be done on 3 occasions: at 9 pm after 4hs of fasting, at 6 am and at 11 am. The brachial artery images will be acquired above the antecubital fossa in the longitudinal plane of the artery with an ultrasound machine using a 6-MHz linear transducer. Flow-mediated vasodilatation will be assessed by the reactive hyperemia method (inflation of a blood pressure cuff around the forearm to 200 mmHg for 5 minutes and then released). The diameter of the brachial artery will be assessed 60 to 90 s after deflation of the cuff. After a 10min period a second baseline image of the brachial artery will be obtained. Non-low-mediated vasodilatation will be measured by an administration of a sublingual dose of nitroglycerin (0.4 mg).
16308562|NCT00583375|Device|Augment® Bone Graft|Augment® Bone Graft
16308563|NCT00583375|Procedure|Standard of Care|Autologous Bone Graft
16308564|NCT00583362|Biological|Belimumab|Belimumab 10mg/kg IV over one hour every 28 days
16308565|NCT00583349|Drug|Paclitaxel, nanoparticle albumin-bound|Intravesically administered, dose escalation, 6 weekly instillations
16308566|NCT00583336|Device|ShuntCheck|Thermal dilution test for CSF flow
16308567|NCT00583323|Drug|Lomotil|Orally 10ml of Lomotil
16308568|NCT00583323|Other|Normal saline|10 ml orally
16308569|NCT00583310|Behavioral|Telephone-based lifestyle counseling|Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.
16308570|NCT00583271|Drug|triamcinolone|80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
16308571|NCT00583271|Drug|98% dehydrated alcohol|10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB
16308572|NCT00583258|Drug|Alfuzosin (Xatral)|10 mg PO once a day
16308573|NCT00583258|Drug|Placebo Alfuzosin|10 mg PO once a day
16308574|NCT00583245|Other|Gait Training|Gait training with physical therapist 2/week for 3 months
16308575|NCT00583232|Drug|Stable isotope infusions|Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
16308576|NCT00583219|Drug|Botulinum-A toxin|A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
16308577|NCT00583219|Drug|Dimethyl sulfoxide (DMSO)|Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.
16308578|NCT00583193|Drug|Duloxetine hydrochloride|Start 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg.
16308579|NCT00583180|Drug|Capsaicin|instillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study.
16308580|NCT00583154|Drug|BLI-801|Dose 1
16308581|NCT00583154|Drug|BLI-801|Dose 2
16308582|NCT00583154|Drug|BLI-801|Dose 3
16308583|NCT00583154|Drug|BLI-801|Dose 4
16308584|NCT00583128|Drug|AST-120|oral, sachet, 2 grams three times daily for 8 weeks
16308585|NCT00583128|Drug|Celphere® CP-305|oral, placebo, sachet, 2 grams three times daily for 8 weeks
16308586|NCT00583115|Drug|Gleevec|260 mg/M2/day, given once daily by mouth
16308587|NCT00583102|Drug|Cytarabine|Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.
16308588|NCT00583102|Drug|Lovastatin|Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day.
16308589|NCT00583076|Drug|AST-120|AST-120, 2grams,three times daily for 4 weeks. Responders in the second cohort of patients are eligible to receive AST-120 for up to 52 weeks.
16308590|NCT00583063|Drug|sunitinib|25 mg daily (oral dosing)
16308591|NCT00583063|Drug|rapamycin|4 mg daily (oral dosing)
16308592|NCT00583050|Device|Endovascular Aneurysm Repair|Endovascular exclusion of aneurysm
16308593|NCT00583037|Device|Neurally Adjusted Ventilatory Assist (NAVA)|Mechanical ventilation controlled by diaphragm electrical activity
16308594|NCT00583024|Biological|ADENOVIRUS/PSA VACCINE|1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
16308595|NCT00583011|Drug|Local Anesthesia|Local anesthesia: 2 cc of 1% Lidocaine
16308596|NCT00583011|Drug|Placebo Group|Placebo Group: 2cc Normal Saline
16308597|NCT00582998|Procedure|Standard Wound Dressing|Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
16308598|NCT00582998|Device|Vacuum Assisted Closure Device|Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
16308599|NCT00582985|Drug|TRC105 chimeric anti-CD105 antibody|TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.
16308600|NCT00582972|Drug|Omeprazole|40 mg po qAM one-half hour before breakfast for 30 days
16308601|NCT00582959|Other|Cone Beam Imaging|Prototype, third generation EPID based portal imaging system utilizing the MV approach.
16308602|NCT00582946|Device|Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.
16308603|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
16308604|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
16308605|NCT00582933|Drug|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF|"All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment.
~The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction."
16308606|NCT00582920|Radiation|Zometa™|Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.
16308607|NCT00582907|Drug|Rilonacept|2.2 mg/kg/wk by subcutaneous injection, for 3 months
16308608|NCT00582907|Drug|Placebo|placebo by subcutaneous injection weekly for 3 months
16308609|NCT00582894|Drug|Busulfex, Fludarabine, ALemtuzumab|Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
16308610|NCT00582868|Device|Licox Brain Oxygen Monitor|use of data from brain oxygen monitor for analysis
16308611|NCT00582868|Other|CSF|analysis of CSF for cleaved tau protein
16308612|NCT00582868|Other|Whole blood|Analysis of whole blood for cleaved-tau protein
16308613|NCT00582855|Drug|AQW051|
16308614|NCT00582855|Drug|Placebo|
16308645|NCT00582556|Drug|Zometa|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
16309096|NCT00578682|Biological|MEDI-557|Single IV dose of 15 mg/kg
16308615|NCT00582842|Behavioral|Interview|The phone interview will consist of the following items from the follow up questionnaire; 14, 16, 20, 32, 33, 46, 47, 60, and 65. An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
16308616|NCT00582842|Behavioral|survey instruments using Web-Based Data Collection System (WBDC) survey content|The content of the WBDC questionnaire will be similar to the paper form, no alteration in the wording, the order, or the formate of the items will be done. In addition, at the time of each outpatient clinic visit to MSKCC, these subjects will be able to login to WBDC using a computer located in the patient waiting-area, and enter their responses to the different items of the questionnaire if their clinic visit corresponds to any of the study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment). An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
16308617|NCT00582829|Other|Generic Print Intervention|"Generic Print Intervention: The generic print intervention will consist of the pamphlet, Colorectal Cancer Screening Saves Lives published by the Center for Disease Control that will be mailed to the participant."
16308618|NCT00582829|Other|Tailored Print Intervention|Tailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant.
16308619|NCT00582829|Other|Tailored print plus tailored phone intervention|Tailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information.
16308620|NCT00582816|Device|Clinimacs Cell Separation System|Depletion of T-cells
16308621|NCT00582816|Drug|conditioning chemotherapy|Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab.
16308622|NCT00582816|Other|DLI|NK Cell selected DLI
16308623|NCT00582790|Drug|IL2|Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.
16308624|NCT00582790|Drug|Zoledronic acid|Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.
16308625|NCT00582777|Behavioral|USUAL - take your BP Meds as you usually do|The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning.
16308626|NCT00582777|Behavioral|HS DOSING|Take your usual BP meds at bed time
16308627|NCT00582777|Drug|ADD On Dosing|Take your usual BP meds but add one more med at bed time.
16308628|NCT00582764|Other|perform dynamic contrast enhanced (DCE) MRI|With an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection.
16308629|NCT00582738|Drug|CsA-TAC (standard Treatment)|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
16308630|NCT00582738|Drug|Everolimus|Hepatitis C recurrence after orthotopic liver transplantation (OLT)
16308631|NCT00582725|Drug|R-CHOP+GM-CSF|addition of GM-CSF
16308632|NCT00582712|Drug|Lithium carbonate|Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.
16308633|NCT00582699|Behavioral|assessment interview and blood draw|All subjects will be administered a battery of clinician rated and self report instruments including measures of depression, fatigue, and cognitive functioning. In addition, measures of pain, sleep, and anxiety will also be utilized to assess these important potential confounding variables. The SCIDIV will be used to ascertain the presence or absence of a current DSMIV diagnosis of Major Depressive Episode for all subjects. The interview should take approximately fortyfive minutes to complete. Patients will have their blood drawn once, in order to determine plasma levels of the cytokines IL1, IL6, TNFalpha, IL10, IL15 and IFNgamma.
16308634|NCT00582686|Procedure|ORIF of Calcaneus with bone grafting|The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting
16308635|NCT00582686|Procedure|ORIF of Calcaneus without bone grafting|The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)
16308636|NCT00582673|Drug|AFQ056|
16308637|NCT00582673|Drug|Placebo|
16308638|NCT00582660|Drug|Celecoxib|400 mg twice a day for 7 days prior to surgery
16308639|NCT00582660|Drug|Placebo|one tablet of placebo will be given for 7 days prior to surgery
16308640|NCT00582634|Drug|docetaxel and cisplatin|Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.
16308641|NCT00582608|Drug|131I-8H9|This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m^2 dose [intended specific activity of ~20 mCi/mg protein]
16308642|NCT00582608|Drug|8H9|administration of 50mg/1.73m^2 of unlabeled 8H9.
16308643|NCT00582582|Drug|Docetaxel plus doxercalciferol|Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
16308644|NCT00582582|Drug|Docetaxel plus placebo|Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
16308646|NCT00582556|Drug|zometa|GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6
16308647|NCT00582556|Drug|Zometa|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
16308648|NCT00582543|Other|eMRI/MRSI|Patients will undergo eMRI/MRSI examination. All subjects will be asked to administer a Fleet enema on the day of the study in order to reduce the potential for fecal residue to interfere with imaging acquisition and quality. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position. The entire eMRI/MRSI study will be performed within 55-60 minutes.
16308649|NCT00582530|Other|Whole Blood Draw|The plan is to obtain the research blood sample at the time of routine preoperative and postoperative blood testing, typically performed 1-2 weeks prior to surgery and then again 6 weeks to 12 months after surgery
16308650|NCT00582517|Device|Compass Universal Hinge External Fixator|Application of the Compass Knee Hinge adds approximately 30 minutes to the surgical time. After the apparatus has been in place for the appropriate amount of time (6-8 weeks), it is removed either in the clinical setting, or in the one-day surgery area of UAB Highlands.
16308651|NCT00582517|Procedure|Non-invasive External Knee Brace|For Group A patients, an external knee brace (several brands available and no one brace specified for this study) will be placed on the leg following surgical repair of the knee dislocation.
16308652|NCT00582504|Biological|VEE TC-83|Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm
16308653|NCT00582491|Drug|Modafinil|Modafinil 400mg orally every day for 16 days
16308654|NCT00582491|Drug|Placebo|Placebo orally everyday for 16 days
16308655|NCT00582478|Behavioral|questionnaires|Participants will be followed regularly at 3, 6, 12, and 18-month intervals
16308656|NCT00582452|Other|Telephone survey|Telephone survey
16308657|NCT00582439|Device|Reamer-Irrigator-Aspirator (RIA)|Patients must already be scheduled for bone grafting of a fracture or nonunion with harvest of autologous graft material from their femur using the RIA system. The reaming procedure will be conducted using the trochanteric entry portal through the tip of the greater trochanter.
16308658|NCT00582426|Drug|Octreotide Long Acting Release|Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first.
16308659|NCT00582426|Other|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
16308660|NCT00582413|Behavioral|questionnaires|Patient will fill out questionnaires, initial clinic visit, first post-surgery clinic evaluation and 3, 6, 12, 18 and 24 months following completion of all therapy.
16308661|NCT00582400|Drug|arsenic trioxide|"Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.
~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
16308662|NCT00582387|Genetic|specimen samples|blood, urine and tissue
16308663|NCT00582387|Behavioral|questionnaires|
16308664|NCT00582361|Procedure|Standard Wound Dressing|Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
16308665|NCT00582361|Device|VAC|Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
16308666|NCT00582309|Procedure|Glucommander-Guided Intravenous Insulin Infusion|"Glucommander-Guided Intravenous Insulin Infusion.
~Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids.
~During the infusion, enter glucose levels into the Glucommander and follow recommendations regarding infusion rate and time to measure next blood glucose levels."
16308667|NCT00582309|Procedure|Standard Intravenous Insulin Infusion|"Standard Intravenous Insulin Infusion Standard Intravenous Insulin Infusion in the ICU setting Prepare IV Insulin Drip: 250 units of glulisine (Apidra®) insulin with 250 ml NS (1.0 unit/ml). Piggyback insulin drip into IV fluids.
~Algorithm 1: Start here for most patients. Algorithm 2: For patients not controlled with Algorithm 1, or receiving glucocorticoids, or patient with diabetes receiving >80 units/day of insulin as an outpatient.
~Algorithm 3: For patients not controlled on Algorithm 2.No Patients Start Here."
16308668|NCT00582309|Procedure|Simple Calculated Intravenous Insulin Infusion|If the patient was on insulin prior to this admission, 1/2 of the total insulin dose divided by 24 will be the initial insulin infusion rate. The amount of insulin given will be dependant upon blood sugar levels ( BG levels 80-120= 0.5 units/hr, 121-160=1.0 units/hr, 161-200= 2.0 units/hr, 201-240= 3.0 units/hr, 241-280= 4.0 units/hr, 281-320= 5.0 units/hr, 321-360=6.0 units, 361-400= 7.0 units, greater than 400= 8.0 units.
16308669|NCT00582296|Behavioral|questionnaires, telephone interview, optional blood drawn|Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).
16308704|NCT00581945|Drug|Canakinumab|The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
16308670|NCT00582296|Behavioral|questionnaires, telephone interview and optional blood drawn|Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).
16308671|NCT00582283|Drug|I124-NM404|I-124-NM404
16308672|NCT00582257|Behavioral|questionnaires|Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
16308673|NCT00582244|Behavioral|CBT and relaxation|Group A: CBT and relaxation.
16308674|NCT00582244|Behavioral|Physical activity|Group B: Physical exercise program.
16308675|NCT00582244|Behavioral|CBT and physical activity|Group AB: Combined CBT and exercise program. Women assigned to Group AB will undergo the CBT and exercise elements of the program concurrently. To as great an extent as possible, the on-site CBT and in-clinic exercise training sessions will be scheduled on the same day.
16308676|NCT00582244|Other|Control group|Waiting list control group
16308677|NCT00582231|Other|Questionnaires.|Questionnaires.
16308678|NCT00582205|Drug|Paclitaxel, Cisplatin IP|Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
16308679|NCT00582192|Other|Consult visit|Your appointment with your doctor will be audio taped. The research team will listen to the tape(s) and type them up. The team will then look for patterns in the discussions between patients and doctors. They will use this information to see if the discussions can be improved.
16308680|NCT00582179|Procedure|Standard Pressure Dressing|If hematoma still draining at 5 days post surgery, patients who randomize to Group A will have a standard pressure dressing applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
16308681|NCT00582179|Device|VAC|If hematoma still draining at 5 days post surgery, patients who randomize to Group B will have a VAC negative pressure device applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
16308682|NCT00582166|Drug|Ibritumomab Tiuxetan (Zevalin) + Rituximab|Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
16308683|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
16308684|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
16308685|NCT00582140|Biological|pTVG-HP with rhGM-CSF|pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
16308686|NCT00582114|Drug|Lisinopril|Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
16308687|NCT00582114|Drug|Atenolol|Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
16308688|NCT00582101|Behavioral|Family-Based HIV Prevention for Latinos|7-hour one-day workshop with adolescents and parents in separate and joint sessions
16308689|NCT00582101|Behavioral|General Health Promotion|7 hour one-day workshop on general health promotion topics
16308690|NCT00582088|Biological|VEE C-84|Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20.
16308691|NCT00582075|Drug|temozolomide|TMZ 200mg/m2 days 1-5 repeat q28 days. Patients who have received prior chemotherapy will receive 150 mg/m2 days 1-5
16308692|NCT00582062|Other|washings for experimental marker testing|During the laparoscopy, a small amount of a mild salt solution will be introduced to gently wash the inside of the abdomen. The fluid will be removed and sent to the laboratory for two analyses: 1) washings for cytology (routine), and 2) washings for experimental marker testing (experimental).
16308693|NCT00582036|Drug|Regular Insulin|Use of sliding scale insulin as per Appendix 1
16308694|NCT00582036|Device|Deployment of the MiniMed Paradigm monitoring device|Automated insulin delivery system
16308695|NCT00582010|Drug|inhaled nitric oxide|inhaled 80ppm for duration of surgery.
16308696|NCT00582010|Drug|nitrogen gas|inhaled
16308697|NCT00581997|Drug|QAX576|
16308698|NCT00581997|Drug|Placebo|
16308699|NCT00581971|Drug|celecoxib|400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
16308700|NCT00581971|Drug|Carboplatin|IV, AUC 2.0, weekly for weeks 1 through 7
16308701|NCT00581971|Drug|Paclitaxel|IV 30 mg/m2, weekly for weeks 1 through 7
16308702|NCT00581971|Radiation|Radiation Therapy|70.2Gy, at 1.8Gy qd, Monday through Friday
16308703|NCT00581958|Other|Blood Samples|blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
16308705|NCT00581945|Drug|Placebo|Matching placebo to ACZ885 administered via intravenous infusion.
16308706|NCT00581919|Drug|Bort, Dex, and Dox with ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
16308707|NCT00581906|Radiation|DCE-MRI, DW-MRI and MRS|Pts undergo DCE-MRI, DW-MRI or 1^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners. Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) & group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI &/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite & will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment. Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible. 1st intra-treatment DCE-MRI is recommended between the 1st & 2nd weeks of treatment & the 2nd intra-treatment DCE-MRI is recommended between the 3rd & 4th weeks of treatment.
16308708|NCT00581893|Drug|Phenytoin|Phenytoin will be dosed to a target dose of 5 mg/kg qhs for one month
16308709|NCT00581893|Drug|Placebo oral capsule|Placebo
16308710|NCT00581880|Behavioral|questionnaires|A battery of questionnaires concerning your thoughts, opinions, and attitudes about your illness and outlook on life. In addition, we will ask to provide some background information about you and your illness. The questions will take approximately 30 to 45 minutes to complete. You fill out the questionnaire once only.
16308711|NCT00581867|Drug|Insulin Aspart|40IU insulin aspart applied intranasally
16308712|NCT00581867|Drug|Placebo|Placebo
16308713|NCT00581854|Drug|modified Hyper-CVAD|rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
16308714|NCT00581841|Other|Gait analysis, knee x-ray, and knee MRI|Gait analysis, knee x-rays, and knee MRIs will be done twice for each participant, 1 week apart.
16308715|NCT00581828|Drug|Vitamin D|50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)
16308716|NCT00581815|Device|Proton-decoupled 31P MRS at 1.5T|The study will use a dual 1H-31P surface coil pair obtained from IGG Medical Advances, Milwaukee, WI. The coil pair consists of a fixed, 12 cm square 31P resonator co-mounted with a flexible two-loop proton coil. The P.I. and colleagues have used this device for approximately 10 years with no apparent ill effects
16308717|NCT00581815|Device|1H Spectroscopy at 1.5T and 3T|The study will use surface coils manufactured by commercial vendors. The pulse sequence programs to be used will be monitored automatically by the scanner to insure that SAR limits are not exceeded.
16308718|NCT00581789|Drug|erlotinib, sunitinib|erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
16308719|NCT00581776|Drug|Bortezomib|Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
16308720|NCT00581776|Drug|Rituximab|Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
16308721|NCT00581776|Drug|Cyclophosphamide|Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
16308722|NCT00581776|Drug|Doxorubicin|Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
16308723|NCT00581776|Drug|Vincristine|1 mg administered by IV on day 3 of each cycle.
16308724|NCT00581776|Drug|Dexamethasone|40 mg orally on days 1-4 of each cycle.
16308725|NCT00581750|Other|Tissue specimen|Human tissues taken after the clinically indicated removal of these tissues from patients as part of their routine care.
16308726|NCT00581724|Behavioral|Telephone interview or self report survey.|We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.
16308727|NCT00581711|Other|3-Part Intervention|A combination of training, an otitis media episode grouper, and clinical decision support.
16308728|NCT00581711|Other|4-Part Intervention|A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
16308729|NCT00581711|Other|1-part intervention|Provision of feedback on otitis media quality indicators
16308730|NCT00581685|Drug|Pregabalin, Celecoxib|Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
16308731|NCT00581672|Behavioral|questionnaires of quality of life|Subjects will be asked to complete the MAX-PC along with additional psychosocial questionnaires which include anxiety, depression coping methods, resilience spirituality, religiosity, and quality of life measures and will take approximately one 30 to 45 minutes to complete by patient.
16308732|NCT00581646|Behavioral|survey instrument|Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
16308733|NCT00581633|Other|normal saline (0.9%)|liter normal saline over 30 minutes x 1 dose
16308734|NCT00581620|Biological|pneumococcus conjugate vaccine|Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
16308735|NCT00581607|Drug|Bosentan|62.5 mg bid for 4 weeks, then 125 mg bid
16308736|NCT00581607|Drug|Placebo|Placebo twice a day
16308737|NCT00581607|Drug|Bosentan|drug given for 16 weeks
16308738|NCT00581607|Drug|Placebo|placebo
16308776|NCT00581256|Radiation|IMRT|All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.
16309081|NCT00578799|Dietary Supplement|Kyo-Dophilus|5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening
16309082|NCT00578799|Dietary Supplement|placebo|placebo capsules (potato starch
16308739|NCT00581594|Procedure|Graft-augmented colporrhaphy|Patients will undergo randomized surgical procedure. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years for a pelvic exam for evaluation of posterior wall support and the questionnaires.
16308740|NCT00581594|Procedure|Traditional posterior colporrhaphy|Patients will undergo randomized surgical procedure. Patients will be seen at 2 weeks for routine post-op care and evaluation of any post-op complications. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months, for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years to have a pelvic exam for evaluation of posterior wall support and the questionnaires.
16308741|NCT00581568|Other|Cutaneous Effects of Cryogen Spray Cooling|Cutaneous Effects of Cryogen Spray Cooling
16308742|NCT00581555|Drug|Etanercept|Etanercept 50 mg QW initiated during taper of ciclosporin
16308743|NCT00581555|Other|Placebo|Randomized to placebo during taper of ciclosporin
16308744|NCT00581542|Drug|moxifloxacin|1-2 drops three times a day for 8-10 days.
16308745|NCT00581542|Drug|polytrim|1-2 drops four times a day for 8-10 days.
16308746|NCT00581529|Radiation|IMRT|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
16308747|NCT00581503|Device|diagnostic|oct imaging
16308748|NCT00581477|Drug|droxidopa|up to 300mg four times daily
16308749|NCT00581477|Drug|placebo|same frequency as experimental medication
16308750|NCT00581477|Drug|alpha-methyldopa|up to 250mg two times daily
16308751|NCT00581477|Drug|carbidopa|up to 25mg four times daily
16308752|NCT00581477|Drug|metyrosine|up to 1000mg three times daily
16308753|NCT00581477|Drug|levodopa|up to 250mg three times daily
16308754|NCT00581477|Drug|atomoxetine|up to 40mg twice daily
16308755|NCT00581477|Drug|metoclopramide|up to 10mg four times daily
16308756|NCT00581464|Behavioral|Standard Behavioral Therapy|Standard therapy to help participants with smoking cessation.
16308757|NCT00581464|Behavioral|Mindfulness Based Addiction Therapy|A novel mind body therapy that extends basic behavioral therapy principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
16308758|NCT00581451|Drug|bifeprunox|oral tablet once daily
16308759|NCT00581425|Biological|Imiquimod and Interferon alpha|Imiquimod first two weeks and last two weeks. Interferon middle five weeks.
16308760|NCT00581399|Device|NO-NUMO™ High Vacuum Body Cavity Drainage System|(1) disposable NO-NUMO™ body cavity drainage tubes, (2) disposable Vario™ fluid management canisters and (3) Vario™ portable vacuum pump
16308761|NCT00581399|Device|PVC Chest Tube|Standard PVC Chest Tube Sizes 14-36 French
16308762|NCT00581386|Device|LTS-D|supra-glottic airway device
16308763|NCT00581386|Device|ProSeal Laryngeal Mask Airway|pre-existing double-lumen supra-glottic device
16308764|NCT00581386|Device|Esophageal Tracheal Combitube (ETC)|disposable double-lumen tube
16308765|NCT00581373|Other|water 16 fl oz|water 16 fl oz in AM and repeat in late afternoon
16308766|NCT00581360|Drug|doxorubicin and bortezomib|Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges.
16308767|NCT00581347|Other|outreach services|Tracking/reminder/recall/home visit strategy.
16308768|NCT00581334|Procedure|Robotic-assisted laparoscopic sacrocolpopexy|4 abdominal incisions will be made: 1 infraumbilical port and 3 lateral ports. The peritoneum overlaying the sacrum is entered and the anterior longitudinal ligament is exposed. 3 permanent sutures are placed through the ligament at the S2-S3. Then a vaginal obturator is placed transvaginally and the apex of vagina is elevated into the operative field. The peritoneum overlying the anterior and posterior vaginal epithelium is reflected and the bladder is dissected off the underlying vagina to expose 4cm of apical vagina. 2 segments of polypropylene mesh are prepared and one segment is anchored along the anterior vagina with a series of interrupted permanent suture and the second segment is anchored along the posterior vagina. These 2 segments are brought together to the previously placed sutures within the anterior longitudinal ligament of the sacrum. The peritoneum is then closed over the graft complex and the pelvis irrigated. The 4 robotic ports are removed and the abdomen closed.
16308769|NCT00581321|Dietary Supplement|water|water 500 ml x 1
16308770|NCT00581308|Device|GORE® HELEX® Septal Occluder|Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)
16308771|NCT00581295|Device|Diffuse optical spectroscopy|Diffuse optical spectroscopy measurment
16308772|NCT00581282|Radiation|PET scan|positron emission tomography PET scan
16308773|NCT00581282|Other|fMRI|functional magnetic resonance imaging fMRI
16308774|NCT00581269|Behavioral|low-impact aerobic exercise|subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
16308775|NCT00581269|Dietary Supplement|low-calorie (low-fat) diet|subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
16309083|NCT00578786|Drug|ambrisentan|2.5, 5.0 or 10.0 mg ambrisentan po, qd, long-term
16308777|NCT00581256|Radiation|3D|All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease
16308778|NCT00581243|Drug|SLV-313 SR|sustained relase tablets taken once daily for 14 days
16308779|NCT00581230|Device|Laryngoscopy with RAMP|inflatable positioning ramp
16308780|NCT00581230|Device|Laryngoscopy without RAMP|Laryngoscopy without RAMP
16308781|NCT00581217|Other|Aquacel Ag|Aquacel Ag will be applied to one donor site.
16308782|NCT00581217|Other|Glucan II|Glucan II to be applied to a donor site on same patient for comparison
16308783|NCT00581204|Device|Near-Infrared Diffuse Optical Spectroscopy|Early predictor of hemorrhagic shock
16308784|NCT00581191|Drug|SLV-351|SLV-351 capsules taken once
16308785|NCT00581165|Drug|Etanercept|recommended dose of enbrel is 25mg administered twice weekly.
16308786|NCT00581139|Behavioral|Preoperative Preparation Program (Child Life Specialist)|This group will receive the standard preoperative visit to the hospital with Child Life intervention
16308787|NCT00581139|Drug|Midazolam|0.5 mg/kg oral midazolam
16308788|NCT00581139|Behavioral|Parental Presence during Induction of Anesthesia|One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.
16308789|NCT00581139|Other|PPIA preparation program PLUS Midazolam premedication|Subjects in this group will receive both interventions 2 and 3.
16308790|NCT00581126|Drug|Recombinant Factor IX Coagulation|Benefix IV each 12 hours for 2 a 5 days
16308791|NCT00581113|Radiation|Radiotherapy|Treatments are delivered through parallel opposed or 5 degree RAO/LAO fields that cover the entire cranial contents. There should be beam fall-f of at least 1 cm. The eyes must be excluded from the beam either by field arrangement or shielding.
16308792|NCT00581100|Drug|etanercept|"Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.
~Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period."
16308793|NCT00581087|Drug|DHEA treatment|DHEA : 200 mg/day hard gelatine capsule
16308794|NCT00581087|Drug|Placebo|Treatment : 200 mg/day hard gelatine capsule
16308795|NCT00581074|Behavioral|diet (grapefruit or grapefruit juice)|weight loss diet
16308796|NCT00581061|Drug|Vesicare|Vesicare will be taken daily for one or three months, depending on symptoms of subject.
16308797|NCT00581048|Drug|Natural source d-α-tocopheryl acetate|1500 units daily for 16 weeks
16308798|NCT00581035|Biological|Prevenar and Meningitec|1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months
16308799|NCT00581035|Biological|Prevenar|1 dose at 2,3.5,6 and 12 months
16308800|NCT00581035|Biological|Meningitec|1 dose at 2,6 and 12 months
16308801|NCT00581022|Procedure|Polysomnography|Overnight Sleep Study
16308802|NCT00581009|Other|chronobiological augmentation|Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days
16308803|NCT00581009|Drug|sertraline, lithium|"Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.
~Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks."
16308804|NCT00581009|Radiation|one night of sleep deprivation and two FDG PET scans|MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.
16308805|NCT00580996|Other|water high dose|water 16 oz PO x 1
16308806|NCT00580996|Other|water tiny dose|water 1 oz PO x 1
16308807|NCT00580983|Radiation|IMRT|
16308808|NCT00580983|Drug|Paclitaxel|
16308809|NCT00580983|Drug|Carboplatin|
16308810|NCT00580983|Drug|Cisplatin|
16308811|NCT00580983|Drug|5-Fluorouracil|
16308812|NCT00580970|Drug|lovastatin|The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.
16308813|NCT00580957|Drug|Blocked|Trimethaphan 4 mg/min IV will be infused for the duration of the study. L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance
16308814|NCT00580957|Drug|Intact|Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance
16308815|NCT00580944|Procedure|laser treatment of port wine stain birthmarks|Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
16308816|NCT00580931|Drug|Nicotinamide|1500 mg twice a day for 6 months
16308817|NCT00580931|Drug|Enduramide placebo|1 tab twice a day
16308818|NCT00580918|Other|functional magnetic resonance imaging fMRI|functional magnetic resonance imaging fMRI
16308819|NCT00580905|Drug|Adenosine|IV infusion of adenosine at a dose of 80 mcg/kg/min for 30 minutes.
16308820|NCT00580905|Drug|Sodium Nitroprusside|To compare the effects of adenosine on increasing cytokines, sodium nitroprusside will be infused at 5 mcg/kg/min (a dose expected to produce similar systemic effects to adenosine)
16309084|NCT00578773|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16308821|NCT00580905|Drug|Adenosine|"The local effects of adenosine or sodium nitroprusside will be studied in response to microinjection (intradermally) of both drugs. Two microdialysis catheters (CMA 100) will be inserted intradermally in the volar aspect of the forearm after numbing the area with local cold (ice applied in the study area). After 30 minutes,one catheter will be infused with sodium nitroprusside (2microliters/min of a 28 mM solution) and the other with adenosine (2mcl/min of a 100 microM solution) will then be started and continued for 60 minutes. Skin blood flow will be monitored throughout the study with the used of a skin laser Doppler fluxometer mounted adjacent to the area of the microdialysis probe.
~A 2 mm skin biopsy punch will be performed 60 minutes after the end of the infusion."
16308822|NCT00580892|Device|Optical Coherence Tomography imaging|Optical Coherence Tomography imaging
16308823|NCT00580866|Device|JAS Brace|For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
16308824|NCT00580853|Drug|varenicline|2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
16308825|NCT00580853|Drug|bupropion|300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
16308826|NCT00580853|Drug|Placebo|Placebo
16308827|NCT00580840|Drug|Certolizumab pegol|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
16308828|NCT00580840|Drug|Certolizumab pegol|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
16308829|NCT00580840|Other|Placebo|placebo (saline) administered as two injections every 2 weeks
16308830|NCT00580827|Drug|Placebo|Matched placebo.
16308831|NCT00580827|Drug|Disulfiram|disulfiram at 62.5 mg/day for 12 weeks.
16308832|NCT00580827|Drug|Disulfiram|Disulfiram at 125 mg/day for 12 weeks.
16308833|NCT00580827|Drug|Disulfiram|disulfiram at 250 mg/day for 12 weeks.
16308834|NCT00580814|Drug|Methylphenidate|Methylphenidate
16308835|NCT00580801|Drug|Telaprevir|Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
16308836|NCT00580801|Drug|Pegylated-interferon-alfa-2a|Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
16308837|NCT00580801|Drug|Placebo|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
16308838|NCT00580801|Drug|Ribavirin|Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
16308839|NCT00580788|Drug|PTHrP (1-36)|IND # 49,175
16308840|NCT00580762|Procedure|Roux-en-y gastric bypass (RYGB)|
16308841|NCT00580749|Procedure|Naso jejunal feeding tube insertion|Placement of feeding tube through nare and into jejunum for administration of enteral feeding.
16308842|NCT00580749|Procedure|NG feeding tube insertion|Placement of naso gastric feeding tube into stomach for purpose of enteral feedings.
16308843|NCT00580736|Device|Optical Clearing|Optical Clearing
16308844|NCT00580723|Other|PRK 124|Topical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks
16308845|NCT00580684|Biological|pneumococcus conjugate vaccine 7 valent to reduce carriage|plain polisacaride vaccine 23 valent to reduce carriage
16308846|NCT00580671|Behavioral|MET/CBT|Weekly Individual Counseling Sessions
16308847|NCT00580671|Behavioral|CM|Abstinence-based incentives delivered contingent on drug-negative urine test results.
16308848|NCT00580671|Behavioral|BPT|Behavioral parent training involve 14 weekly counseling curriculum to improve parenting skills.
16308849|NCT00580658|Device|Medtronic Activa Gpi|Activa Therapy, Gpi
16308850|NCT00580645|Drug|varenicline|2mg/day or 1mg/day with 1-week medication lead-in period.
16308851|NCT00580645|Drug|placebo|placebo
16308852|NCT00580619|Other|Autonomic Function Testing|The autonomic function tests include asking the subject to breathe deeply for two minutes and breathing as fast and as hard as they can for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, placing one hand in ice water for 1 minute and an orthostatic test. All these tests are meant to stimulate the autonomic nervous system to produce changes in blood pressure and heart rate of short duration that reflect how well the involuntary nervous system is working. In addition, a 24-hour blood pressure monitoring and exercise test may be also performed in some subjects.
16308853|NCT00580619|Other|Saline infusions|The effects of continuous IV infusion or pulse IV administration of saline in increasing total blood volume and fatigue score will be evaluated
16308854|NCT00580619|Drug|L-NMMA trimethaphan|Trimethaphan IV infusion for approximately 60 minutes at a dose of 4-6 mg/min L-NMMA IV infusion for approximately 45 minutes at 125, 250, and 500 mg/kg/min for 15 minutes each
16308855|NCT00580619|Drug|methyldopa|Aldomet oral twice a day for 12 weeks
16308856|NCT00580606|Drug|Glycerinated peanut allergenic extract|Glycerinated peanut extract delivered sublingually.
16308857|NCT00580606|Drug|Placebo for peanut extract (glycerin)|Placebo (glycerin) delivered sublingually.
16308858|NCT00580593|Device|BiPAP® S/T System|The BiPAP® S/T System is a NIPPV device that provides intermittent ventilatory assistance to people with difficulty breathing secondary to respiratory muscle weakness.
16308859|NCT00580593|Other|sham-NIPPV|a sham-device
16308860|NCT00580580|Drug|Optison|0.1-0.4 mL through intravenous injection at the beginning of the study.
16308861|NCT00580580|Drug|Definity|intravenous injection at 0.05-0.20 mL
16308862|NCT00580580|Drug|PESDA|intravenous injections dosage 0.05-0.20 mL
16308863|NCT00580541|Behavioral|variety|variety and nonvariety
16308864|NCT00580528|Behavioral|Tailored Internet Newsletters|Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
16308865|NCT00580528|Behavioral|Tailored print newsletters delivered via mail|Tailored Newsletters with content to improve eating and activity to reduce blood pressure
16309085|NCT00578773|Drug|Moxifloxacin otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16309091|NCT00578721|Drug|Aspirin|325 mg taken daily with an arginine-restricted diet
16308866|NCT00580515|Behavioral|Family Focused Group Therapy|6 Sessions of Family Focused Group Therapy (FFGT). The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases. The first two sessions are assessment sessions and occur one week apart. There will be two or six focused intervention sessions depending on the predetermined length of therapy. The first focused intervention session is approximately two weeks after the last assessment session. Subsequent focused intervention sessions are expected to follow once every month. Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart. The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months.
16308867|NCT00580515|Behavioral|Family Focused Group Therapy|10 Sessions of Family Focused Group Therapy (FFGT). The FFGT intervention will have assessment, focused therapy, consolidation, and termination phases. The first two sessions are assessment sessions and occur one week apart. There will be two or six focused intervention sessions depending on the predetermined length of therapy. The first focused intervention session is approximately two weeks after the last assessment session. Subsequent focused intervention sessions are expected to follow once every month. Finally, there will be two consolidation/termination sessions, which will occur one time each, approximately two months apart. The six session program is expected to extend over a period of 6 months and the 10 session program over 10 months
16308868|NCT00580515|Behavioral|Standard of Care|Standard of Care Families assigned to the Usual Care Condition will receive standard psychosocial care which is based on the following patterns: Social work consultations are routinely provided to the cancer patients, but relatives are only seen during admissions or upon request.
16308869|NCT00580502|Device|LAP-BAND® Adjustable Gastric Band (LAGB®)|Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2
16308870|NCT00580489|Drug|either fentanyl or morphine|either morphine 4mg IV or fentanyl 50mcg IV
16308871|NCT00580450|Drug|Thymosin alpha 1|1.6 mg sc once a day for 16 weeks
16308872|NCT00580437|Procedure|Dobutamine Stress Echocardiogram|stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition
16308873|NCT00580424|Drug|Norethindrone|Norethindrone 0.35 mg orally daily
16308874|NCT00580398|Behavioral|Smoking cessation counseling|Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
16308875|NCT00580398|Drug|varenicline|varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
16308876|NCT00580385|Other|Tissue Procurement|MTX polyglutamylation, MTX transport, XTT cytotoxicity assays, Quantitative RT-PCR, Southern blotting, Mutation detection, and Western blotting
16308877|NCT00580372|Drug|VAD|3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
16308878|NCT00580372|Drug|High-Dose cyclophosphamide|"Approximately 5-6 weeks after VAD 2 or 3:
~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1"
16308879|NCT00580372|Procedure|Hemopoietic stem cell procurement|Collection target = 10 x 10^6 cells/kg
16308880|NCT00580372|Drug|EDAP|Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5
16308881|NCT00580372|Procedure|Autologous Hemopoietic Stem Cell Transplant 1|4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2
16308882|NCT00580372|Procedure|Autologous Hemopoietic Stem Cell Transplant 2|4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2
16308883|NCT00580372|Drug|Maintenance|3 months after Transplant 2: Intron A 3 X 10^6 units /m2 M-W-F subcutaneously until relapse
16308884|NCT00580359|Drug|S-1, capecitabine|S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
16308885|NCT00580346|Device|Placement of laryngeal implant|Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
16308886|NCT00580333|Drug|cisplatin|Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
16308887|NCT00580333|Drug|bevacizumab|Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
16308888|NCT00580333|Drug|doxorubicin|Postoperative: Given intravenously for four 2-week cycles
16308889|NCT00580333|Drug|cyclophosphamide|Postoperative: Given intravenously for four two-week cycles
16308890|NCT00580333|Drug|paclitaxel|Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)
16308891|NCT00580320|Drug|Dacarbazine and bortezomib|Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
16308892|NCT00580307|Procedure|Septoplasty|Surgical straightening of nasal septum
16308893|NCT00580307|Procedure|Septoplasty and endoscopic contact point correction|Septoplasty (as previously described). Contact point correction: structures of the lateral nasal wall that impinge on the nasal septum are mobilized to a more lateral position under endoscopic guidance.
16308894|NCT00580294|Drug|Oxymorphone|IV PO
16308895|NCT00580281|Other|blood test, urine test, and bone density x-ray.|start of the study (month 0), and at months 3, 6, 9, 12 (1 year), 15, 18, 21, and 24 (2 years)
16308896|NCT00580242|Drug|Bortezomib|First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
16308897|NCT00580242|Drug|Bortezomib|Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
16308898|NCT00580242|Drug|Bortezomib|Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days
16308899|NCT00580242|Drug|Lenalidomide|Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period
16308900|NCT00580229|Drug|prednisone|prednisone 40mg by mouth 30-60 minutes prior to rituximab
16308901|NCT00580216|Drug|Idrabiotaparinux sodium|"Pre-filled syringes containing:
~0.5 mL for the 3.0 mg dosage;
~0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
~0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
~Subcutaneous injection"
16308902|NCT00580216|Drug|Warfarin|"Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
~Oral administration"
16308903|NCT00580216|Drug|Placebo (for idrabiotaparinux)|"Matching pre-filled syringes containing:
~0.5 mL for the 3.0 mg dosage;
~0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
~0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
~Subcutaneous injection"
16308904|NCT00580216|Drug|Placebo (for warfarin)|"Warfarin matching capsules
~Oral administration"
16308905|NCT00580216|Drug|Avidin|"Vial containing 105 mg of lyophilized powder for dilution
~Intravenous infusion for 30 minutes"
16308906|NCT00580216|Drug|Placebo (for avidin)|"Vial containing 105 mg of matching lyophilized powder for dissolution
~Intravenous infusion for 30 minutes"
16308907|NCT00580190|Drug|alprazolam|tablet, 0.5 mg, single dose, only on Day 7 of the study
16308908|NCT00580190|Other|Placebo|solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study
16308909|NCT00580190|Drug|PF-00572778|solution, 500 mg, single dose, only on Day 7 of the study
16308910|NCT00580177|Procedure|Lichtenstein mesh|The different techniques are compared and evaluated according to primary and secondary objectives.
16308911|NCT00580177|Procedure|PerFix Plug®|The different techniques are compared and evaluated according to primary and secondary objectives.
16308912|NCT00580177|Procedure|Prolene® Hernia System|The different techniques are compared and evaluated according to primary and secondary objectives.
16308913|NCT00580151|Drug|clonidine|3-5 microgram per kilogram every 6 hours for 10 days
16308914|NCT00580151|Drug|placebo|1 dose every 6 hours
16308915|NCT00580125|Drug|PF-00217830|PF-00217830 5 mg, oral capsule, once daily for 21 days
16308916|NCT00580125|Other|Placebo|Placebo, oral capsule, once daily for 21 days
16308917|NCT00580125|Drug|Aripiprazole|Aripiprazole 15 mg, oral capsule, once daily for 21 days
16308918|NCT00580125|Drug|PF-00217830|PF-00217830 15 mg, oral capsule, once daily for 21 days
16308919|NCT00580125|Drug|PF-00217830|PF-00217830 2 mg, oral capsule, once daily for 21 days
16308920|NCT00580112|Drug|Dexamethasone|Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
16308921|NCT00580112|Drug|Trabectedin|Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
16308922|NCT00580099|Other|assisted exercise|4 weeks of passive range of motion exercise
16308923|NCT00580099|Other|cuddle|cuddle infant for 20 minutes
16308924|NCT00580086|Other|MR spectroscopy|(1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI
16308925|NCT00580073|Drug|FOLFOX4|oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
16308926|NCT00580073|Drug|Cetuximab|Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
16308927|NCT00580060|Biological|GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)|In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations.
16308928|NCT00580047|Drug|Zoledronic Acid|4mg IV Annually
16308929|NCT00580047|Combination Product|Calcium with vitamin D|1200 mg Calcium with 800 International Units of vitamin D
16308930|NCT00580047|Drug|Alendronate|70mg weekly
16308931|NCT00580034|Drug|Campath Purged Non-myeloablative ASCT|"Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
16308932|NCT00580034|Procedure|Donor Apheresis|Donor will receive Granulocyte colony-stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.
16308933|NCT00580021|Other|Genotyping|Samples for DNA extraction will be shaved from archival paraffin-embedded tissue blocks (using normal lymph node preferentially)and placed in appropriate receptacles labeled only with the subject unique study number. This material will be transported to the genotyping laboratory, where it will be stored until the clinical record abstraction is complete. Briefly, DNA will be extracted from the archive paraffin-embedded material using standard protocols and the samples will be analyzed for the presence of the Ashkenazi BRCA founder mutations using either PCR-based or gel-electrophoresis-based approaches.
16308934|NCT00579995|Drug|Oral N-Acetylcysteine|600 mg
16308935|NCT00579995|Drug|Intravenous Sodium Bicarbonate|3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
16308936|NCT00579982|Drug|Lamotrigine|Experimental formulation
16308937|NCT00579969|Drug|Latanoprost|dosage form:eye drops, dosage: One drop in each eye twice a day
16308938|NCT00579969|Drug|Timolol|dosage form:eye drops, dosage: One drop in each eye twice a day
16308939|NCT00579956|Drug|Meropenem|Meropenem 1gm, diluted with 50ml normal saline solution IV every 8 hours for at least 10 days. The dose will be adjusted according to the creatinine clearance.
16308940|NCT00579956|Drug|Ceftazidime|Ceftazidime 120mg/kg/day divided into 3 equal doses (maximum dose 2 gram/dose), diluted with 50ml normal saline solution IV every 8 hours for at least 10 days The dose will be adjusted according to the plasma creatinine level
16308941|NCT00579917|Behavioral|Cognitive Behavioral Therapy: Questionnaires|CBT, we will interview you again after you have completed the 10 sessions. We call these follow-up interviews, and they include several phone calls and a questionnaire you would be asked to complete and then mail in. Each follow-up interview will take between 60 and 210 minutes. If you wish, these follow-up interviews can be done over different days. We will do the follow-up interviews three times; at approximately 4 months, 7 months, and 10 months after you complete the baseline interview.
16308942|NCT00579917|Behavioral|Usual Care: Questionnaires|If you receive Usual Care, you will not receive CBT while you are in the study. You will complete the questionnaires at the same time as participants who receive CBT. If you receive Usual Care you will be offered 10 sessions of CBT at no charge at the end of the study.
16308943|NCT00579904|Dietary Supplement|walnuts|Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.
16308944|NCT00579904|Dietary Supplement|almonds|Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.
16308945|NCT00579878|Drug|Leflunomide|A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diarrhea, liver enzyme elevations
16308946|NCT00579878|Drug|Methotrexate-Sulfasalazine-Hydroxychloroquine|"Methotrexate:
~dosing starts at 10mg/week (4 tabs/wk). If total remission (according to ACR criteria found in Appendix II) has not been achieved and the labs are acceptable at the 8-week evaluation, the dose increased to 15 mg/week (6 tabs/wk);at the 16-week evaluation, the dose increased to 20 mg/week (8 tabs/wk). This dose will remain stable until the end of the study.
~Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable,dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day)."
16308947|NCT00579878|Drug|Leflunomide-Sulfasalazine-Hydroxychloroquine|Leflunomide: dose of 100 mg (or placebo) for three (3) days. Followed by a dose of 20 mg/day will be maintained throughout the remainder of the study. dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur Sulfasalazine: dosing will start at 500 mg bid (1000 mg/day). This dose will remain steady until the 24-week evaluation. If total remission has not been achieved by this time and the labs remain acceptable, dose will be increased to 1000 mg bid (2000 mg/day) Hydroxychloroquine: dosing will be started and maintained throughout the study at 200 mg bid (400 mg/day).
16308948|NCT00579865|Behavioral|questionnaires|complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.
16308949|NCT00579865|Behavioral|questionnaires|complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.
16308950|NCT00579852|Procedure|CT Scan|Patients with NSCLC undergoing non-contrast CT scan of the chest will have a second, high resolution, non-contrast CT scan of the chest performed on the same day. The scans will be performed on the same CT scanner, generally within 30 minutes. Unidimensional, bi-dimensional, and volume measurements for the primary NSCLC lesion will be determined on both scans and the values compared. After completing the second scan, the patient will have completed participation in the protocol.
16308951|NCT00579839|Procedure|Delayed Cord Clamping|Delayed Cord Clamping: 30-35 seconds after birth
16308952|NCT00579839|Procedure|Immediate Cord Clamping|Immediate Cord Clamping: within 5 seconds of birth
16308953|NCT00579826|Drug|Letrozole|Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
16308954|NCT00579826|Drug|Placebo|Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
16308955|NCT00579813|Drug|Pioglitazone|Pioglitazone 30mg for 2 weeks, then Pioglitazone 45mg for 8 weeks.
16308956|NCT00579800|Procedure|new software sequences, FIESTA and Vibrant-DE and IDEAL|Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.
16308957|NCT00579774|Other|Low AGE Diet|Diet
16308958|NCT00579774|Other|Regular Diet|Diet
16308959|NCT00579709|Biological|Thymus Tissue for Transplantation|"3 Thymoglobulin doses given prior to thymus tx. Atypical subjects given Cyclosporine (Csa) pre-tx. Desired Csa concentration 180-300ng/ml. If post-tx T cell count remained <4000/cumm Csa weaned over 8 weeks. If T cell >4,000/cumm, Csa held at 180-300ng/ml.
~Thymus tissue, donor, & mother of donor were screened for transplant safety. In operating room, thymic slices were transplanted into quadriceps muscle in 1 or both legs.
~Subjects had routine blood research immune evaluations. 2-3 months post-tx, open biopsy of allograft. Immune blood studies continued on surviving subjects until January 2010. Biological Mother: Mother provided blood sample used for DNA extraction, to identify/look for maternal T cell presence in recipient pre-tx, and/or for immune testing post-tx."
16308960|NCT00579683|Other|Tumor core biopsy for RNA isolation|RNA isolation will be carried out using approximately 25 mg of gross tissue from these tumor specimens.
16308961|NCT00579670|Drug|Ziprasidone|Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection
16308962|NCT00579657|Other|control diet, supported by dietary supplement twice daily|control diet, see above
16308963|NCT00579657|Other|high cereal fiber diet, supported by dietary supplement twice daily|high cereal fiber diet, see above
16308964|NCT00579657|Other|high protein diet, supported by dietary supplement twice daily|high protein diet, see above
16308965|NCT00579657|Other|diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily|MIX diet, see above
16308984|NCT00579527|Drug|Tacrolimus|If unable to tolerate cyclosporine, then tacrolimus is given. Tacrolimus may be given every 8 to 12 hours enterally or IV before and after the CTTI transplant. Tacrolimus dose is dependent on the T cell numbers and the target tacrolimus trough levels. Tacrolimus is weaned as per protocol.
16309092|NCT00578708|Device|AMPLATZER Membranous VSD Occluder|Device closure with the AMPLATZER Membranous VSD Occluder
16308966|NCT00579644|Drug|Combination of Minocycline and MTX or MTX alone|"Methotrexate Dosing:
~1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
~3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
~4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg"
16308967|NCT00579644|Drug|methotrexate|"Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
~2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
~4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
~6, 8 and 10 month evaluations:
~If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
~If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study."
16308968|NCT00579631|Behavioral|Questionnaire or Interview|Complete a self-report survey once over the telephone or by mail. The questions are about your health beliefs and behaviors, your current health, and your mood. It should not take longer than 45 minutes to complete. About 15 of these people will participate in an additional, short audiotaped interview about sun protection.
16308969|NCT00579618|Other|Saliva or Blood samples|Extracting sample of saliva or blood only once.
16308970|NCT00579605|Behavioral|Motivational Interviewing|Client-centered strategy that may decrease ambivalence in behavior performance with attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
16308971|NCT00579592|Drug|Campath-1H, rituximab, myfortic|Campath-1H 30mg IV x 2 doses, rituximab 375mg/m2 IV x 1 dose, myfortic 720mg bid, cyclosporine po bid (target trough 200ng/ml) x 10-20 days
16308972|NCT00579579|Behavioral|Questionaires|Prior to surgery, patients will be asked to complete baseline surveys. In addition, a random subsample of approximately 30 patients will be asked to participate in a short qualitative interview to explore expectations regarding bowel function and quality of life following surgery. Follow-up surveys will be completed at 6, 12 and 24 months after bowel continuity has been restored (defined by their last surgical procedure). Patients with a permanent stoma will receive the Stoma-specific QOL questions in place of the MSKCC Bowel Function Instrument at 6 and 12 months after initial surgery.
16308973|NCT00579566|Other|Specimen protocol|The research specimen will be obtained from the residual specimen that would otherwise be discarded per usual hospital procedure.
16308974|NCT00579553|Drug|Intramuscular Progesterone|Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
16308975|NCT00579553|Drug|Vaginal Progesterone|Vaginal Progesterone: 100 mg vaginal suppository daily
16308976|NCT00579540|Dietary Supplement|Flax Seed Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
16308977|NCT00579540|Dietary Supplement|Fish Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
16308978|NCT00579540|Dietary Supplement|Soybean Oil|Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
16308979|NCT00579527|Biological|Cultured Thymus Tissue for Implantation (CTTI)|Potential thymus recipient subjects are screened for eligibility. Thymus donor (unrelated donor), and thymus donor's birth mother are screened for safety. CTTI is done under general anesthesia in the operating room. Cultured thymus tissue is implanted into the subject's quadriceps. Two to three months post CTTI, if medically stable, the subject undergoes allograft biopsy. At the time of implantation and biopsy, a skin biopsy is done. Immunosuppression is weaned as per protocol.
16308980|NCT00579527|Other|Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation|For subjects w/ hypoparathyroidism, the subject may receive CTTI and parathyroid transplant. For parathyroid transplant, parental parathyroid donors are screened. Parathyroid is harvested from the parent who shares the most Human Leukocyte Antigens (HLA) alleles with the thymus donor. Parathyroid gland is minced and placed in quadriceps muscle; there is no dose. Parathyroid donors are monitored as outpatients until recipients' discharge. Recipients' calcium and PTH levels are monitored indefinitely. Potential thymus recipient subjects are screened for eligibility. Thymus donor (unrelated donor), and thymus donor's birth mother are screened for safety. CTTI is done under general anesthesia in the operating room. Cultured thymus tissue is implanted into the subject's quadriceps. Two to three months post CTTI, if medically stable, the subject undergoes allograft biopsy. At the time of CTTI and biopsy, a skin biopsy is done. Immunosuppression is weaned as per protocol.
16308981|NCT00579527|Procedure|Blood Draw|Birth mothers of Thymus Recipients are asked to participate in the study and undergo phlebotomy to allow testing of T cell identity in the Complete DiGeorge subjects. If blood is not obtainable then a buccal swab may be done.
16308982|NCT00579527|Drug|Rabbit anti-thymocyte globulin|Three doses of 2 mg/kg IV (through a central venous catheter) prior to CTTI. Each dose of Rabbit anti-thymocyte globulin (RATGAM) is given over 12 hours. RATGAM is usually given on days-5, -4, and -3 prior to CTTI or CTTI and parathyroid transplantation. Medications (diphenhydramine, steroids, and acetaminophen) are given with rabbit anti-thymocyte globulin.
16308983|NCT00579527|Drug|Cyclosporine|"In addition to RATGAM, subjects with typical cDGA with PHA responses >50,000 cpm, or atypical cDGA with PHA response <75,000cpm (when not on immunosuppression) or <40,000 cpm to PHA while on immunosuppression, are started on cyclosporine (Csa) as soon as cDGA is diagnosed. Csa is continued with target trough levels of 180 to 220 ng/ml. If subject cannot tolerate Csa, Csa may be changed to tacrolimus (FK506) with target trough level 7 to 10 ng/ml. When trough levels are outside of range, dosing is modified appropriately.
~Csa may be given every 8 to 12 hours enterally or IV before and after CTTI. The Csa dose is dependent on T cell numbers and the target Csa trough levels. Csa is weaned as per protocol."
16309093|NCT00578695|Drug|lixivaptan|Oral Capsule
16308985|NCT00579527|Drug|Methylprednisolone or Prednisolone|Steroids IV or enterally may be given before and after CTTI or CTTI and parathyroid transplantation. Administration and dosage depends on T cell numbers and symptoms. Pre-transplant steroids may be used when pre-transplant T cells >4,000cumm. Steroids are weaned as per protocol.
16308986|NCT00579527|Drug|Daclizumab|In addition, subjects with Atypical DiGeorge with PHA responses >75,000cpm while on no immunosuppression or PHA responses >40,000cpm while on immunosuppression, Daclizumab 1 mg/kg single dose IV may be given depending on T cell counts. Administration of Daclizumab depends on T cell numbers and T cell activation. A single dose may be given after the administration of rabbit anti-thymocyte globulin and before CTTI. If Daclizumab is not given before CTTI, and, depending on the T cell numbers and T cell activation, a single dose of Daclizumab may be given 3-5 days after CTTI.
16308987|NCT00579527|Drug|Mycophenolate mofetil|In addition, subjects with Atypical DiGeorge with PHA responses >75,000cpm while on no immunosuppression or PHA responses >40,000cpm while on immunosuppression, Mycophenolate mofetil 15 mg/kg/dose every 8 hours IV or enterally may be given depending on T cell counts. Mycophenolate mofetil may be given if the T cell count remains elevated 5 days after CTTI. If MMF is given, the dose is 15 mg/kg IV. MMF may be stopped at 35 days after CTTI or continued for up to six months after CTTI.
16308988|NCT00579514|Genetic|PCR/PCR/LDR Strategy|Evaluate the extent to which polymorphisms in BRCA1, BRCA2, PTEN, T β R1, TGF β-1, DNA repair genes (including ATM and CHK2), APC, ER, PR, MCP-1, MPIF, CCR2/5 and CCR3 are correlated with cancer incidence. Candidate genes will also be selected from 1) cytokine signaling and 2) apoptosis regulatory pathways.
16308989|NCT00579501|Drug|Trabectedin|Trabectedin 1.5 mg/m^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.
16308990|NCT00579501|Drug|Dexamethasone|Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
16308991|NCT00579475|Drug|Mifegyne|tablets, 50 mg every other day
16308992|NCT00579475|Drug|placebo|
16308993|NCT00579462|Other|Blood and Tissue studies|Blood will be collected from participating patients at baseline, as close as possible to the date of their baseline radiologic assessment. Three follow-up blood collections will be drawn, each within 7-10 days of each follow-up radiologic evaluation.
16308994|NCT00579449|Behavioral|Healthy Families Durham|Implementation of Healthy Families America program plus Parents As Teachers curriculum
16308995|NCT00579449|Behavioral|Yearly Checkup|Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.
16308996|NCT00579436|Drug|omega-3 fatty acid|4g of omega-3 fatty acid daily by mouth for 12 weeks.
16308997|NCT00579436|Drug|placebo|4 inert capsules daily by mouth for 12 weeks.
16308998|NCT00579423|Biological|QS21|"Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug.
~Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs.
~Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient."
16308999|NCT00579384|Drug|JNJ-26489112|Single oral dose of JNJ-26489112 up to 3000 mg on Day 2.
16309000|NCT00579384|Drug|Placebo|Single dose of placebo on Day 1, and a second single dose of placebo on Day 3.
16309001|NCT00579371|Drug|Islets of Langerhans|Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.
16309002|NCT00579345|Biological|Cell culture derived seasonal trivalent influenza vaccine (cTIV)|cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
16309003|NCT00579345|Biological|Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).|egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
16309004|NCT00579345|Biological|cTIV or eTIV_a|0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.
16309005|NCT00579345|Biological|cTIV+PV OR eTIV_a+PV|0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).
16309006|NCT00579332|Dietary Supplement|brassica intervention|diet and phyto-chemical intervention
16309007|NCT00579280|Drug|quetiapine SR|flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
16309008|NCT00579280|Drug|divalproex sodium ER|Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
16309009|NCT00579280|Drug|placebo|placebo
16309010|NCT00579267|Other|MINI-KID|Structured Diagnostic Interview for children and adolescent psychiatric disorders.
16309011|NCT00579254|Drug|CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)|Patients who have been treated with Caduet 5/10 or 5/20 mg single pill treatment, based on their clinical conditions and latest locally approved packet insert recommendations will be eligible to be enrolled to this study
16309012|NCT00579241|Procedure|Ultrasound on Temporal Bone|All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
16309041|NCT00579033|Other|Tactile training + rTMS|tactile training 2.5/hr/day for 15 days plus daily 5Hz rTMS
16309042|NCT00579020|Drug|Moxifloxacin/dexamethasone phosphate ophthalmic solution|
16309043|NCT00579020|Drug|Moxifloxacin ophthalmic solution 0.5%|
16309044|NCT00579020|Drug|Dexamethasone phosphate solution, 0.1%|
16309086|NCT00578773|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
16309087|NCT00578760|Drug|aspirin|325mg ASA OD for the duration of the cisplatin
16309088|NCT00578760|Drug|placebo|OD for course of cisplatin chemotherapy
16309013|NCT00579215|Behavioral|Enhance Care|EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits
16309014|NCT00579215|Behavioral|Usual Care|As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.
16309015|NCT00579202|Device|Gambro HD-C4 Small Dialyzer|Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.
16309016|NCT00579189|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16309017|NCT00579189|Drug|Moxifloxacin otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16309018|NCT00579189|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
16309019|NCT00579137|Biological|Campath -1H|"Given intravenous on Days -8,-7, and -6
~Campath dose is weight based: for patients less than 15 kg the dose is 3 mg; for patients >15 kg to 30 kg the dose 5 mg; for patients > 30 kg the dose is 10 mg"
16309020|NCT00579137|Drug|Fludarabine|"Given intravenous on Days -8,-7,-6,-5, and -4
~Dose is 30 mg/m2"
16309021|NCT00579137|Biological|Anti-CD45|"Given intravenous over 6 hours on Days -5,-4,-3, and -2
~Dose is 400 microgram/kg"
16309022|NCT00579137|Procedure|Stem cell infusion|stem cells are infused on day 0
16309023|NCT00579124|Device|CliniMACs|T and B Cell depletion
16309024|NCT00579111|Drug|Campath|10 mg/day IV daily for 3 days on days -6 to D-4. Campath may be omitted from the conditioning regimen for patients with malignant diseases and matched related donor transplants
16309025|NCT00579111|Drug|Busulfan|3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4
16309026|NCT00579111|Drug|Fludarabine|30mg/m2/day IV daily for 4 days on Day -5 to D -2
16309027|NCT00579111|Procedure|Hematopoietic stem cell infusion|Peripheral blood stem cells when possible. Bone marrow cells will be used if peripheral blood cells are insufficient or unavailable.
16309028|NCT00579111|Drug|FK-506|FK-506 at a dose of 0.03 mg/kd/day will be administered via continuous infusion over 24 hours from 4pm on Day -2 until engraftment or when the patient is able to take PO, then 0.03 mg/kg PO every 12 hours.
16309029|NCT00579098|Drug|Atorvastatin|80 mg tablet taken by mouth daily for 90 days
16309030|NCT00579098|Drug|Placebo|Placebo tablet taken by mouth once daily for 90 days
16309031|NCT00579085|Drug|Ketamine|IV Ketamine .35mg/kg times ten days.
16309032|NCT00579085|Other|IV NSS|Placebo inactive ingredients
16309033|NCT00579085|Other|Normal Saline|"INFUSION PLAN:
~All patients will be infused intravenously with 100 ml of normal saline for four hours (25 ml/hr) daily for 10 days.Both patient arms will receive 2mg of Versed x two doses IV. They will also receive Clonidine (0.1 mg, po)"
16309034|NCT00579072|Behavioral|Questionaires|We will use a 6-month longitudinal design to assess the short-term cognitive effects of androgen ablation therapy. We will collect 6-month longitudinal data on 170 men with prostate cancer. All 170 men will be hormone naïve at the start of this study (Hormone Naïve Group). These 170 men will consist of two subgroups. The first subgroup will comprise 70 men with prostate cancer age 65 and older scheduled to start androgen ablation therapy. Their cognitive functioning will be assessed prior to starting androgen ablation therapy or within 21 days after initiation, (i.e. baseline) and then 6 months later (Androgen Ablation Subgroup).The second subgroup will serve as a control group, and consist of 100 men with prostate cancer age 65 and older who are at least 1-year post definitive localized treatment with no evidence of disease and no plan to start androgen ablation therapy (No Androgen Ablation Subgroup).
16309035|NCT00579072|Behavioral|Questionaires|To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group).
16309036|NCT00579072|Device|fMRI scan (optional)|Main study participants will be offered to complete an optional fMRI. Fifteen participants from the No Androgen Ablation Subgroup and 15 participants from the Comparison Androgen Ablation Subgroup or Longitudinal Androgen Ablation Subgroup will be recruited for this portion of the study. The fMRI will be scheduled either the same day as the neurocognitive assessment or within eight weeks of the neurocognitive testing. The fMRI will be performed only once at baseline for the Comparison Androgen Ablation Subgroup. The fMRI will be performed at the follow-up time point for the Longitudinal Androgen Ablation Subgroup. The fMRI will be performed at baseline for the No Androgen Ablation Subgroup; if the fMRI can not be completed at baseline (due to participant schedule conflict, lack of fMRI availability, staff schedule conflict, etc.), then the scan will be conducted at the follow-up time point if possible.
16309037|NCT00579059|Device|Maxim® Knee System with Removable Molded Polyethylene Tibia|Used for total knee replacements
16309038|NCT00579059|Device|Regular Maxim® Knee System|Used for total knee replacements
16309039|NCT00579046|Drug|Darbepoetin alfa|"Dosage form: injection (to store between 2 and 8 °C). Dosage: various dosages are available (10, 15, 20, 30, 40, 50, 60, 80, 100, 150 or 300 µg/ml).
~Frequency: every week for 2 months: 8 injections"
16309040|NCT00579033|Other|Tactile training + sham rTMS|tactile training for 2.5/hr/day for 15 days - this plus the sham rTMS
16309089|NCT00578734|Drug|Lucinactant|Slow intra-tracheal instillation
16309045|NCT00579007|Behavioral|telephone interviews|Telephone interviews take place before the first counseling appointment (baseline), and 1 week, 6 months and 12 months post-notification of the individual's genetic test results. In the event that a participant chooses not to undergo genetic testing, follow-up interviews will take place 1 month, 6 months and 12 months after the initial counseling visit.
16309046|NCT00578994|Device|Oxford® Meniscal Unicompartmental Knee System|Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.
16309047|NCT00578981|Behavioral|Osteoporosis Choice Decision Aid|The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
16309048|NCT00578968|Drug|Tiotropium|Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device.
16309049|NCT00578968|Drug|Placebo|Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.
16309050|NCT00578955|Drug|1% Azithromycin and 0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16309051|NCT00578955|Drug|1% Azithromycin|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16309052|NCT00578955|Drug|0.1% Dexamethasone|Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
16309053|NCT00578942|Drug|Campath Purged Non-myeloablative ASCT|"Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
16309054|NCT00578929|Drug|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine HCl 1 or 2 sprays per nostril twice daily
16309055|NCT00578929|Drug|Vehicle|Vehicle 1 or 2 sprays per nostril twice daily
16309056|NCT00578916|Drug|EVRI (BMS-690514)|Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay
16309057|NCT00578903|Drug|Cytoxan|Cytoxan will be given at 50 mg/kg per dose for 4 successive days.
16309058|NCT00578903|Drug|Campath|Campath will be given at a dose of 3 mg for patients whose weight is between 5 and 15 kg; at a dose of 5 mg for patients whose weight is between 16 and 30 kg; and at a dose of 10 mg for patients whose weight is greater than 30 kg. The last dose of Campath should be 24 hours or more before stem cell infusion.
16309059|NCT00578903|Radiation|Total Body Irradiation (TBI)|TBI will be given at a dose of 200 cGy for 6/6 HLA match and at a dose of 400 cGy in two fractions of 200 cGy each for 5/6 HLA matched donor.
16309060|NCT00578903|Drug|FK-506|FK-506 will be given at a dose of 0.03 mg/kg/day via continuous infusion over 24 hours from 4pm on day -2 until engraftment or when patient is able to take by mouth (PO), then 0.03 mg/kg PO every 12 hours.
16309061|NCT00578903|Drug|Methotrexate|Methotrexate will be administered on day +1, day +3, day +6 and day +11 at a dose of 5 mg/m2. The day +11 dose may be omitted at the discretion of the bone marrow transplant (BMT) in-patient attending physician.
16309062|NCT00578903|Procedure|Stem cell infusion|Where possible patients will receive bone marrow. Marrow will be collected as per National Marrow Donor Program (NMDP) guidelines to provide a volume of 15-20 ml/kg of marrow and/or 2-4 X 10^8 nucleated cells/kg. In case marrow cannot be collected, peripheral blood stem cell (PBSC) will be substituted. A minimum of 5-6 X 10^6 CD 34+ cells/kg should be collected, with a target of 10 X 10^6/kg.
16309063|NCT00578890|Procedure|Medical/surgical treatment versus medical treatment|A 12 week course antibiotics versus a limited resection of infected bone associated with a 4 week course antibiotics.
16309064|NCT00578877|Device|SILCS Diaphragm|SILCS Diaphragm used with 5 ml gel
16309065|NCT00578877|Combination Product|Nonoxynol-9 Gel|Gynol II (2% N-9 gel)
16309066|NCT00578877|Combination Product|Buffer Gel|Buffer Gel
16309067|NCT00578864|Drug|Protracted Oral Etoposide|"Cisplatin with Oral Protracted Etoposide for cycles 1, 2 and 4
~Day 1 - 5
~Hour 0: Etoposide 50 mg/m2 po daily
~Hours 1 to 7: Cisplatin 40 mg/m2
~Day 6 - 14
~Etoposide 50 mg/m2 po once daily"
16309068|NCT00578864|Drug|Doxorubicin|"Given together with cyclophosphamide for cycle 3 and 5 of induction chemotherapy Day 1 and 2
~Hours 0 to 6: Cyclophosphamide 2000 mg/m2 (67 mg/kg if < 12 kg) with Mesna 400 mg/m2 (13 mg/kg if < 12 kg) in D5½NS 600 mL/m2 IV over 6 hours to run at 100 mL/m2/hr
~Hours 6 to 6.25: Doxorubicin 37.5 mg/m2 (1.25 mg/kg if < 12 kg) IV over 15 minutes"
16309069|NCT00578864|Drug|IV Bolus Etoposide|"Cisplatin with Bolus IV Etoposide
~Day 1
~Hours 0 to 6: Cisplatin 40 mg/m2
~Days 2, 3, 4:
~Hours 0 to 1: Etoposide 200 mg/m2 Hours 1 to 7: Cisplatin 40 mg/m2
~Day 5:
~Hours 0 to 6: Cisplatin 40 mg/m2"
16309070|NCT00578864|Drug|Cisplatin|Cycle 1, 2, and 4
16309071|NCT00578864|Drug|Cyclophosphamide|Cycle 3 and 5 with doxorubicin
16309072|NCT00578864|Drug|Mesna|Standard weight-based dosing with cyclophosphamide
16309073|NCT00578864|Drug|Hematopoietic Factor|Standard weight-based dosing after cycle 3 and 5 and if needed for neutropenic recovery after cycles 1,2 and 4
16309074|NCT00578864|Procedure|Primary tumor resection|Resection of primary tumor after cycle 3, 4, or 5 as clinically appropriate
16309075|NCT00578851|Device|C2a - Taper™ Acetabular System|The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.
16309076|NCT00578838|Other|Magnetic Resonance|Patients each will undergo 4 MR examinations as part of this research study.
16309077|NCT00578838|Other|Magnetic Resonance|You will have two MR exams on two different days. There will be no injection of contrast material. An MR exam requires about 1 hour. The second MR exam will take place 2-3 weeks after the first one. This second MR exam will take about 1 hour and will look at whether the results from the MR exams are reliable and repeatable.
16309078|NCT00578825|Drug|Lopinavir / Ritonavir plus Ribavirin|
16309079|NCT00578812|Device|Anterior Cervical Discectomy and Fusion (ACDF)|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
16309080|NCT00578812|Device|PCM Cervical Disc|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
16309097|NCT00578682|Biological|MEDI-557|Single IV dose of 30 mg/kg
16309098|NCT00578682|Biological|MEDI-557|Single IV dose of 0.3 mg/kg
16309099|NCT00578669|Drug|Fluoxetine|20mg once daily for 16 weeks
16309100|NCT00578669|Drug|Dextrose|Once daily for 16 weeks
16309101|NCT00578656|Dietary Supplement|Baked Milk|Extensively heated milk
16309102|NCT00578643|Drug|Busulfan|"Days -9 through -6
~1 mg/kg initially (based on weight)"
16309103|NCT00578643|Biological|Alemtuzumab|"Day -5 through Day -2
~Dose is based on weight:
~Less than 15 kg: 3 mg
~More than 15 kg to 30 kg: 5 mg
~More than 30 kg: 15 mg"
16309104|NCT00578643|Drug|Cyclophosphamide|"Days -5 through -2
~50 mg/kg"
16309105|NCT00578643|Drug|Fludarabine|"Day -5 through Day -2
~30 mg/m^2"
16309106|NCT00578643|Drug|Cyclosporine|Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.
16309107|NCT00578643|Procedure|Stem Cell Infusion|Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells.
16309108|NCT00578630|Other|buccal swabs and obtaining peripheral blood|will be the collection of normal cells and assessments of toxicity following chemotherapy at routine clinic visits.
16309109|NCT00578617|Drug|Rate Control|Metoprolol 50-100mg
16309110|NCT00578617|Device|Ablation Therapy|
16309111|NCT00578617|Drug|Rate Control|Atenolol 50-100mg,
16309112|NCT00578617|Drug|Rate control|Propranolol 40-80mg
16309113|NCT00578617|Drug|Rate control|Acebutolol 200mg
16309114|NCT00578617|Drug|Rate control|Carvedilol 6.25mg
16309115|NCT00578617|Drug|Rate Control|Diltiazem 180-240mg
16309116|NCT00578617|Drug|Rate Control|Verapamil 180-240mg
16309117|NCT00578617|Drug|Rate Control|Digoxin 0.125mg
16309118|NCT00578617|Drug|Rhythm Control|Propafenone 450mg
16309119|NCT00578617|Drug|Rhythm control|Flecainide 200mg
16309120|NCT00578617|Drug|Rhythm control|Sotalol 240mg
16309121|NCT00578617|Drug|Rhythm control|Dofetilide 500mcg
16309122|NCT00578617|Drug|Rhythm control|Amiodarone 200mg
16309123|NCT00578617|Drug|Rhythm control|Quinidine 600-900mg
16309124|NCT00578604|Device|diffuse near infrared spectroscopy measurements|Measure blood flow to diabetic wounds
16309125|NCT00578591|Drug|Rituximab|"Rituximab 375 mg/m^2 is given weekly X 4. For patients with a partial response, an additional 4 doses will be permitted as needed (after 4 weeks from the last dose).
~Diagnosis of grade II to IV aGVHD will be confirmed, whenever possible, by a biopsy taken from at least one of the following three sites: skin, gut, or liver."
16309126|NCT00578578|Dietary Supplement|eicosapentaenoic acid (EPA),|three capsules daily (1350 mg daily) of EPA for 8 weeks or three capsules daily placebo for 8 weeks
16309127|NCT00578565|Drug|Rituximab|Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.
16309128|NCT00578552|Drug|Placebo|Placebo pill - non active sugar pill designed to look alike to the gabapentin medication
16309129|NCT00578552|Drug|Gabapentin - 1800 mg/day|gabapentin - 1800 mg/day for 12 weeks.
16309130|NCT00578552|Drug|Gabapentin - 2700 mg/day|gabapentin - 2700 mg/day for 12 weeks.
16309131|NCT00578539|Drug|ARA C|Ara C (3000 mg/m2) IV every 12 hours for 6 doses (days -8 to -5)
16309132|NCT00578539|Drug|Cyclophosphamide|Cyclophosphamide (45mg/kg) IV once daily on day -7 and day -6
16309133|NCT00578539|Drug|MESNA|MESNA (45mg/kg; divided into 5 doses) will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.
16309134|NCT00578539|Radiation|Total Body Irradiation (TBI)|TBI: total dose 14.0 Gy, will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1
16309135|NCT00578539|Biological|Campath-1h|CAMPATH (3 mg IV for patients between 5 and 15 kg; 5 mg for patients between 16 and 30 kg; and 10 mg for patients greater than 30 kg) will be given on day -4, day -3, day -2 and day-1.
16309136|NCT00578539|Procedure|Stem Cell Infusion|Stem cells are infused on day 0
16309137|NCT00578526|Drug|SU011248|50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
16309138|NCT00578526|Drug|Placebo|50 mg capsule OD PO for 28 days then 14 days rest until disease progression
16309139|NCT00578500|Procedure|ovarian transplantation|Patients will undergo laparoscopic oophorectomy, aspiration of oocytes and maturation followed by cryopreservation. In case of ovarian failure and approval by treating physicians, restoration of fertility will be attempted by thawing of oocytes or by transplantation of ovarian cortex to induce ovulation and obtain oocytes for fertilization and embryo transfer.
16309140|NCT00578474|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16309141|NCT00578474|Drug|Ofloxacin otic solution|5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
16309142|NCT00578474|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
16309143|NCT00578461|Drug|Ara C|3000 mg/m^2 - pts will recieve via IV every 12 hours for 6 doses starting at 20:00 hours on day -8
16309144|NCT00578461|Drug|Mesna|45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide
16309145|NCT00578461|Drug|Cyclophosphamide|45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours
16309146|NCT00578461|Radiation|TBI-Total Body Irradiation|Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4
16309147|NCT00578448|Drug|Belatacept|IV infusion
16309148|NCT00578435|Procedure|Busulfan, Cyclophosphamide, BMD|Busulfan 0.8 or 1 mg/Kg/day Days 8-6 Cyclophosphamide 50 mg/Kg/day Days 2-5 BMT Day 0
16309149|NCT00578422|Other|Ivus (Intravascular Ultrasound) of Amputation Specimens|Human lower extremity arterial segments will be obtained at autopsy and from amputation specimens. All imaging studies and vessel fixation will be undertaken immediately upon vessel procurement; in most cases this will occur within 2 hours of dissection and within 24 hours of death. The ex vivo portion of the study will make use of 150 excised vessels obtained over a 48-month period from randomly selected autopsy cases. From these vessels we expect to collect data from a minimum of 560 plaques
16309150|NCT00578422|Procedure|IVUS (Intravascular Ultrasound)|Standard diagnostic arteriographic images will be obtained. Appropriate oblique views will be acquired at the common femoral bifurcation. Next, IVUS will be performed obtaining ultrasound data from a 10 cm lower extremity artery.
16309151|NCT00578396|Dietary Supplement|grapes|1 pound of seedless red grapes
16309152|NCT00578396|Dietary Supplement|grapes|2/3 lb/day fresh red grapes
16309153|NCT00578396|Dietary Supplement|grapes|1/3 lb/day fresh red grapes
16309154|NCT00578383|Device|Low Field Magnetic Stimulation Device|The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.
16309155|NCT00578370|Drug|Ciclosporin 0.5% (Formulation 01B)|Cutaneous emulsion 200µl once a day (26 days)
16309156|NCT00578370|Drug|Ciclosporin 1.5% (Formulation 02B)|Cutaneous emulsion 200µl once a day (26 days)
16309157|NCT00578370|Drug|0.1% betamethasone|Solution 200µl once a day (26 days)
16309158|NCT00578370|Drug|0.005% calcipotriol|Solution 200µl once a day (26 days)
16309159|NCT00578370|Drug|Formulation 00B|Cutaneous emulsion (Vehicle to Formulation 01B and Formulation 02B) 200µl once a day (26 days)
16309160|NCT00578357|Behavioral|personalized feedback intervention|personalized feedback will be sent to participants after they complete and return self-help materials/questionnaires
16309161|NCT00578344|Drug|Busulfan|Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
16309162|NCT00578344|Biological|Campath 1H|Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
16309163|NCT00578344|Drug|Cyclophosphamide and MESNA|Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
16309164|NCT00578331|Drug|Olopatadine 0.6% nasal spray|2 sprays each nostril twice daily
16309165|NCT00578331|Drug|Placebo Nasal Spray|2 sprays each nostril twice daily
16309166|NCT00578318|Behavioral|Motivational Interviewing Active|Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
16309167|NCT00578305|Biological|Rituximab|Rituximab was supplied as a sterile liquid for iv administration.
16309168|NCT00578305|Drug|Placebo|Placebo was supplied as a sterile liquid in single-use vials for iv administration.
16309169|NCT00578305|Drug|Methylprednisolone|
16309170|NCT00578305|Drug|Methotrexate|
16309171|NCT00578305|Drug|Folic acid or folate|
16309172|NCT00578292|Drug|Busulfan|"4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg
~Days -9 through -6"
16309173|NCT00578292|Drug|Fludarabine|30mg/m2 Day -5 through Day -2
16309174|NCT00578292|Drug|Campath 1H|Per institutional guidelines Days -5 through -2
16309175|NCT00578292|Drug|Cyclophosphamide|50 mg/kg Days -5 through -2
16309176|NCT00578292|Drug|MESNA|10 mg/kg x 5 Days -5 through -2
16309177|NCT00578279|Drug|dehydrated alcohol|subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
16309178|NCT00578266|Drug|Cyclophosphamide,Campath IH and TBI|"DAY 5 TREATMENT
~6 5 CYTOXAN 50 mg/kg WITH MESNA
~5 CYTOXAN 50 mg/kg WITH MESNA;
~4 CYTOXAN 50 mg/kgWITH MESNA; CAMPATH 3-10 mg
~3 CYTOXAN 50 mg/kg WITH MESNA; CAMPATH;
~2 TBI; CAMPATH; TACROLIMUS
~1 TBI (second fraction); CAMPATH (am) 0 STEM CELL INFUSION (pm)"
16309179|NCT00578227|Biological|Cervarix™|Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
16309180|NCT00578227|Biological|Twinrix ™ Paediatric|Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
16309181|NCT00578214|Drug|Randomized Midazolam|Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup.
16309182|NCT00578214|Other|Placebo|The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
16309183|NCT00578214|Drug|Local Anesthesia|Lidocaine 1% with 1:100,000 epinephrine
16309184|NCT00578214|Drug|Prospective Midazolam|Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (>45 to 77 kg, 10 mg; >77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.
16309185|NCT00578201|Drug|radiochemotherapy,combination Cetuximab-FOLFOX|objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX
16309186|NCT00578175|Biological|Priorix-Tetra™ (MMRV vaccine 208136)|One subcutaneous injection.
16309187|NCT00578175|Biological|ProQuad®|One subcutaneous injection.
16309188|NCT00578175|Biological|Havrix®|Two intramuscular injections.
16309189|NCT00578175|Biological|Prevnar®|One intramuscular injection.
16309190|NCT00578162|Behavioral|we will screen potential agencies using our CALL SCRIPT and our AGENCY SCREENER|A cancer care facility or 'agency' is the study's unit of analysis. Data about participating agencies will be collected by electronic survey. Agencies will be identified using the NYSDOH's existing mailing list of care facilities located in the five boroughs of New York City, referral databases and resource guides created by the American Cancer Society (ACS), the New York Hospital Directory
16309191|NCT00578149|Drug|Bevacizumab|
16309192|NCT00578149|Drug|Carboplatin|
16309193|NCT00578149|Drug|Paclitaxel|
16309194|NCT00578136|Drug|Bupivacaine|Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.
16309195|NCT00578123|Behavioral|Quality of Life Questionnaires|Three surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper.
16309196|NCT00578110|Device|Glaucoma Diagnosis, Name: Neucodia|Sensitivity and Specificity
16309197|NCT00578097|Biological|Botulinum toxin type A|Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
16309198|NCT00578097|Drug|Placebo|Single injection cycle, intradetrusor injection at baseline (visit 2).
16309199|NCT00578071|Drug|Panitumumab|Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.
16309200|NCT00578071|Drug|Capecitabine|Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation
16309201|NCT00578071|Drug|Oxaliplatin|Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation
16309202|NCT00578071|Radiation|Radiation Therapy (RT)|Daily for 6 weeks
16309203|NCT00578058|Other|Counseling and Sound Therapy|Tinnitus counseling and sound therapy
16309204|NCT00578045|Procedure|Transfusion|Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
16309205|NCT00578032|Behavioral|Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment|All patients will complete the predefined questionnaires at the following four time points along the course of their care: preoperative clinic visit, and 3 months (±1 month), 6 months (±1), and 9 months (1 and +3) post-operatively. Completion of the questionnaires should take approximately 30 minutes
16309206|NCT00578019|Procedure|IM Nailing|Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith & Nephew supracondylar nail.
16309207|NCT00578019|Procedure|LISS|Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA).
16309208|NCT00578006|Behavioral|Questioners|The investigators will ask you to fill out a brief paper questionnaire periodically to tell us how you are feeling, and how satisfied you are with your care.
16309209|NCT00578006|Behavioral|STAR website|You can report your symptoms every time you come to Sloan-Kettering for an appointment or chemotherapy.
16309210|NCT00577993|Drug|Fludarabine|Group 1= 25 mg/m^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m^2 IV over 15 min. Days 1 through 3 for 8 Cycles.
16309211|NCT00577993|Drug|Novantrone|Group 1 = 10 mg/m^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m^2 IV over 15 min. Day 2 of 3rd Sequence.
16309212|NCT00577993|Drug|Decadron|Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year.
16309213|NCT00577993|Drug|Rituximab|Group 1 = 375 mg/m^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m^2 IV Days 1 through 8 of 3rd Sequence.
16309214|NCT00577993|Drug|Interferon|Group 1 = After Completion of Fludarabine, Novantrone, & Rituximab, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine & Novantrone, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m^2 SQ Days 1 through 14 Each Month for 1 year.
16309215|NCT00577993|Drug|Doxorubicin|25 mg/m^2 IV Days 2 & 3 of 1st Sequence.
16309216|NCT00577993|Drug|Vincristine|.7 mg/m^2 IV Days 2 & 3 of 1st Sequence; 1.4 mg/m^2 IV Day 2 of 3rd Sequence.
16309217|NCT00577993|Drug|Bleomycin|5 unit/m^2 IV Days 2 & 3 of 1st Sequence.
16309218|NCT00577993|Drug|Cyclophosphamide|750 mg/m^2 IV Day 2 of 1st Sequence.
16309219|NCT00577993|Drug|Etoposide|40 mg/m^2 IV Days 1 through 4 of 2nd Sequence.
16309220|NCT00577993|Drug|Cisplatin|25 mg/m^2 IV Days 1 through 4 of 2nd Sequence
16309221|NCT00577993|Drug|Ara-C|1.5 gm/m^2 IV Day 5 of 2nd Sequence.
16309222|NCT00577993|Drug|Methyl-Prednisolone|500 mg IV Days 1 through 5 of 2nd Sequence.
16309223|NCT00577993|Drug|Procarbazine|100 mg/m^2 PO Days 2 through 11 of 3rd Sequence.
16309224|NCT00577993|Drug|Prednisone|100 mg PO Days 1 through 5 of 3rd Sequence.
16309225|NCT00577980|Drug|Testosterone|Initial dose of Testosterone 200 mg IM administered followed by 200 mg - 400 mg every 2 weeks.
16309226|NCT00577967|Drug|Gabapentin|
16309227|NCT00577954|Procedure|Multimodal MRI|Multimodal MRI
16309228|NCT00577915|Other|Radiology/MRI scan|MRI spectroscopy
16309229|NCT00577902|Other|Observation|Head and neck cancer patients receiving chemoradiation
16309230|NCT00577889|Drug|gemcitabine hydrochloride|750 mg/m2 Given IV
16309231|NCT00577889|Drug|tanespimycin|154 mg/m2 Given IV
16309232|NCT00577876|Procedure|Trimix Injection with Doppler Ultrasound|"In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL.
~Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion."
16309233|NCT00577863|Drug|teriparatide|Subcutaneous injection of teriparatide 20 micrograms once daily using the Forteo B Pen. The primary phase of the study is 8 weeks after which time patients may participate in a study extension until the patient completes their maximum duration of teriparatide therapy or the Forteo B Pen becomes commercially available.
16309234|NCT00577850|Drug|risedronate|0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks
16309235|NCT00577850|Drug|alendronate|0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks
16309236|NCT00577837|Drug|risedronate|tablet, 5 mg risedronate daily for 6 months
16309237|NCT00577837|Drug|risedronate|tablet, 100 mg risedronate monthly for 6 months
16309238|NCT00577837|Drug|risedronate|tablet, 150 mg risedronate monthly for 6 months
16309239|NCT00577837|Drug|experimental|tablet, 200 mg risedronate monthly for 6 months
16309240|NCT00577824|Drug|exenatide|subcutaneous injection, 5mcg, twice a day
16309241|NCT00577824|Drug|exenatide|subcutaneous injection, 10mcg, twice a day
16309242|NCT00577824|Drug|placebo|subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
16309243|NCT00577798|Drug|doxorubicin hydrochloride|Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lyphoma and Hogdkin's lymphoma
16309244|NCT00577798|Procedure|contrast-enhanced magnetic resonance imaging|Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
16309245|NCT00577785|Other|tissue procurement|No intervention. Tissue procurement study.
16309246|NCT00577772|Drug|Xifaxan|Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients.
16309247|NCT00577772|Device|SmartPill|The SmartPill is a single-use, ingestible capsule that utilizes sensor technology to measure pressure, pH and temperature throughout the entire GI tract. The ACT-1 (SmartPill) GI Monitoring System includes an ingestible capsule, a receiver and video display software.
16309248|NCT00577772|Procedure|Lactulose hydrogen breath test (H_2BT)|A hydrogen breath test provides information about the digestion of certain sugars or carbohydrates, such as milk sugar (lactose) or fruit sugar (fructose). The test is also used for detecting abnormal growth of bacteria within the small bowel by having the patient ingest lactulose.
16309249|NCT00577759|Other|Active Intervention|Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources
16309250|NCT00577759|Other|Passive Intervention|Provision of tools to help with referrals to community resources
16309251|NCT00577759|Other|No intervention|No intervention
16309252|NCT00577720|Drug|risedronate|35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
16309253|NCT00577720|Drug|risedronate|35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
16309254|NCT00577720|Drug|risedronate|50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
16309255|NCT00577720|Drug|risedronate|50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
16309256|NCT00577707|Drug|erlotinib|One tablet daily of erlotinib pills (150 mg daily) for the first 21 days. After surgery, you will be asked to take adjuvant erlotinib 150 mg po daily x 2 years.
16309257|NCT00577707|Drug|Pemetrexed|pemetrexed 500 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
16309258|NCT00577707|Drug|Cisplatin|cisplatin 75 mg/m^2 every 3 weeks for 4 cycles treatment) on the first day of each cycle of treatment.
16309259|NCT00577707|Procedure|Resection|
16309260|NCT00577694|Drug|clofarabine|Intravenous, 20mg/m2, Days 1, 2, 3, 4 and 5; 2 cycles
16309261|NCT00577694|Drug|gemtuzumab ozogamicin|Intravenous, 3mg/m2, Day 1, one cycle
16309262|NCT00577681|Drug|Antiretroviral Therapy (ART)|Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.
16309263|NCT00577668|Drug|Melphalan, Velcade, Thalidomide, Dexamethasone|To assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg.
16309264|NCT00577655|Drug|Albuterol|Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.
16309265|NCT00577655|Drug|Placebo|Placebo HFA MDI four times a day (q.i.d) for 21 days.
16309266|NCT00577655|Drug|Proventil® HFA|Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
16309267|NCT00577642|Drug|Zoledronic acid|4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
16309268|NCT00577629|Drug|cyclophosphamide|1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
16309269|NCT00577629|Drug|etoposide|300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
16309270|NCT00577629|Drug|rituximab|375mg/m2 each week x 4 weeks of induction, beginning on day 1
16309271|NCT00577629|Drug|cytarabine|3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
16309272|NCT00577629|Drug|doxorubicin|45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
16309273|NCT00577629|Drug|tositumomab|450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.
16309274|NCT00577616|Procedure|Endovascular repair|Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
16309275|NCT00577603|Procedure|mesh reinforcement of stoma|Patients randomized to receive mesh will undergo stoma formation and will have a 8 cm x 12 cm piece of AlloDerm graft placed as a tissue reinforcement around the stoma and extending under the midline incision. The mesh will be trimmed to provide a minimum of 3cm of overlap around the stoma in all directions. The mesh will be secured with transabdominal number one Prolene (Ethicon, Inc) sutures every 4cm around the mesh. Additional fixation will be provided with Protack spiral tacks (US Surgical, Inc) every 1cm around the mesh. The midline fascia will be closed with running number one Prolene sutures. Skin will be closed in standard fashion.
16309276|NCT00577603|Other|no intervention|
16309277|NCT00577590|Drug|Metformin|Metformin is taken alone
16309278|NCT00577590|Drug|Rosiglitazone|Rosiglitizone is taken with Metformin
16309279|NCT00577590|Drug|Lovaza|Lovaza is taken with Metformin
16309280|NCT00577577|Drug|rhIGF-I/rhIGFBP-3|1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
16309450|NCT00576342|Drug|AL-3862+timolol ophthalmic suspension|
16309281|NCT00577577|Drug|placebo|1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
16309282|NCT00577512|Drug|DTPACE|"Dexamethasone 200 mg Intravenous Infusion Piggy-Back (IVPB) Days 1-7
~Thalidomide 200 mg by mouth (PO) Days 1-7
~Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency)
~Adriamycin 15 mg/m2 Days 1-4
~Cyclophosphamide 600 mg/m2 Days 1-4
~Etoposide 60 mg/m2 Days 1-4"
16309283|NCT00577473|Drug|mesalamine|mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
16309284|NCT00577473|Drug|mesalamine|mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
16309285|NCT00577460|Drug|Pramipexole|Pramipexole ER 0.375 -4.5 mg
16309286|NCT00577460|Drug|Placebo|Placebo tablets identical to Pramipexole ER tablets
16309287|NCT00577447|Dietary Supplement|docosahexaenoic acid (DHA)|Capsule containing 200mg of DHA
16309288|NCT00577447|Dietary Supplement|Placebo|Placebo capsule containing corn and soybean oil
16309289|NCT00577421|Drug|risedronate|5 mg tablet of risedronate once a day for 2 years
16309290|NCT00577408|Drug|depot naltrexone|On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
16309291|NCT00577408|Drug|Oral Naltrexone|For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
16309292|NCT00577395|Drug|placebo|oral tablet once a month for 12 months
16309293|NCT00577395|Drug|risedronate|tablet, 150 mg once a month for 12 months
16309294|NCT00577382|Drug|Sunitinib|
16309295|NCT00577369|Other|Desflurane Levels|The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.
16309296|NCT00577356|Drug|Docetaxel|Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.
16309297|NCT00577356|Biological|CG1940/CG8711|Immunotherapy allogeneic GM-CSF secreting cellular vaccine
16309298|NCT00577330|Dietary Supplement|Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)|Twice daily
16309299|NCT00577317|Procedure|Management of Therapy Complications|Receive standard home maintenance therapy and perform self-manual lymphatic drainage
16309300|NCT00577317|Procedure|Management of Therapy Complications|Receive Flexitouch home maintenance therapy
16309301|NCT00577317|Other|Quality-of-Life Assessment|Ancillary studies
16309302|NCT00577304|Drug|Nitroglycerin|Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
16309303|NCT00577304|Drug|Topical AmphiMatrix|Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
16309304|NCT00577278|Biological|rituximab|Given IV
16309305|NCT00577278|Drug|fludarabine phosphate|Given IV
16309306|NCT00577278|Drug|melphalan|Given IV
16309307|NCT00577278|Drug|sirolimus|Given PO
16309308|NCT00577278|Drug|tacrolimus|Given PO or IV
16309309|NCT00577278|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo APBSCT
16309310|NCT00577278|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
16309311|NCT00577278|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16309312|NCT00577278|Other|laboratory biomarker analysis|Correlative Studies
16309313|NCT00577200|Drug|Midazolam|Midazolam
16309314|NCT00577200|Drug|Sufentanil|Sufentanil
16309315|NCT00577200|Drug|Propofol|Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
16309316|NCT00577187|Device|EnSite NavX-Guided CRT implant|LV lead placement during CRT implant using EnSite NavX
16309317|NCT00577161|Drug|fludarabine and rituximab|days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
16309318|NCT00577161|Drug|fludarabine, rituximab, pixantrone|days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
16309319|NCT00577148|Drug|Rimonabant|Tablet, oral administration
16309320|NCT00577148|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16309321|NCT00577135|Drug|Furosemide-Q12 hour bolus|Q12 hours bolus
16309322|NCT00577135|Drug|Furosemide-Continuous Infusion|Continuous infusion
16309323|NCT00577135|Drug|Furosemide-Low Intensification|1x oral dose
16309324|NCT00577135|Drug|Furosemide-High Intensification|2.5x oral dose
16309325|NCT00577122|Drug|Medroxyprogesterone progesterone acetate (MPA)|1000 mg po daily
16309326|NCT00577122|Drug|Medroxyprogesterone with Cyclophosphamide + Methotrexate|Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week
16309327|NCT00577109|Drug|bevacizumab [Avastin]|5mg/kg iv on day 1 of each 2 week cycle
16309328|NCT00577109|Drug|Irinotecan|180mg/m2 iv on day 1 of each 2 week cycle
16309329|NCT00577109|Drug|Leucovorin|200mg/m2 iv on day 1 of each 2 week cycle
16309330|NCT00577109|Drug|5 FU|400mg/m2 iv on day 1 of each 2 week cycle
16309331|NCT00577109|Drug|Cetuximab|Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle
16309447|NCT00576368|Drug|INSULIN GLARGINE|The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.
16309332|NCT00577096|Drug|Epoetin Alfa|Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.
16309333|NCT00577096|Behavioral|Exercise|A home-based individualized exercise program that incorporated aerobic and strength resistance training.
16309334|NCT00577096|Biological|Autologous Peripheral Blood Stem Cell Transplantation|Standard PBSCT for multiple myeloma
16309335|NCT00577096|Biological|Red Blood Cell Transfusion|RBC Transfusion was administered as needed
16309336|NCT00577096|Drug|Thalidomide|Fifty percent of the participants received 400 mg daily
16309337|NCT00577096|Drug|Heparin, Low-Molecular-Weight|Patients who received thalidomide also received prophylactic low molecular weight heparin
16309338|NCT00577096|Biological|Platelet Transfusion|Platelet transfusions were administered as needed
16309339|NCT00577096|Drug|Melphalan|Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
16309340|NCT00577096|Drug|Epoetin Alfa|Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl
16309341|NCT00577096|Drug|Total Therapy II|Standard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.
16309342|NCT00577096|Biological|Red Blood Cell Transfusion|RBC Transfusion was administered as needed
16309343|NCT00577096|Drug|Thalidomide|Fifty percent of participants received 400 mg daily
16309344|NCT00577096|Drug|Heparin, Low-Molecular-Weight|Patients who received thalidomide also received prophylactic low molecular weight heparin
16309345|NCT00577096|Biological|Platelet Transfusion|Platelet transfusions were administered as needed
16309346|NCT00577096|Drug|Melphalan|Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
16309347|NCT00577083|Device|Cap-fitted colonoscopy|Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.
16309348|NCT00577070|Device|TMS|Transcranial Magnetic Stimulation (TMS) is a new tool in neuropsychiatry. This method is based on creating pre determined magnetic fields, which alternate rapidly. The magnetic fields are intended to cause electric induction in the brain cells and, as a consequence, generation of action potentials. The magnetic stimulation is delivered/ generated by a coil, positioned on the patient's scalp, inducing nerve stimulation within the brain. Therefore, when placed over the motor cortex, the magnetic stimulation creates Muscular Evoked potential, which can be measured by EMG.
16309349|NCT00577057|Procedure|Conventional Radiotherapy|
16309350|NCT00577057|Procedure|Accelerated Radiotherapy|
16309351|NCT00577057|Drug|Cisplatin|
16309352|NCT00577057|Drug|5-fluorouracil|
16309353|NCT00577057|Drug|Capecitabine|
16309354|NCT00577031|Drug|bevacizumab [Avastin]|7.5mg iv on day 1 of each 3 week cycle
16309355|NCT00577031|Drug|Oxaliplatin|130mg/m2 iv on day 1 of each 3 week cycle
16309356|NCT00577031|Drug|Xeloda|1000mg/m2 po bid on days 1-14 of each 3 week cycle
16309357|NCT00577018|Drug|Prucalopride|4 mg o.d.
16309358|NCT00577018|Drug|Prucalopride|1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter
16309359|NCT00577018|Other|Placebo|o.d.
16309360|NCT00577005|Drug|levetiracetam|The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period.
16309361|NCT00577005|Drug|Placebo|
16309362|NCT00576979|Drug|cyclophosphamide|Given IV
16309363|NCT00576979|Drug|etoposide|Given IV
16309364|NCT00576979|Procedure|allogeneic bone marrow transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
16309365|NCT00576979|Procedure|allogeneic hematopoietic stem cell transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
16309366|NCT00576979|Procedure|peripheral blood stem cell transplantation|Occurs approximately 48 hours after completion of cyclophosphamide
16309367|NCT00576979|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16309368|NCT00576979|Radiation|tomotherapy|Undergo IMRT using helical tomotherapy
16309369|NCT00576940|Drug|Reconvan|isocaloric, immunomodulating entral diet
16309370|NCT00576940|Drug|Peptisorb|isocaloric, isopeptic standard diet
16309371|NCT00576927|Drug|Ramelteon|Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results.
16309372|NCT00576927|Drug|Placebo|
16309373|NCT00576914|Drug|recombinant human endostatin|recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
16309374|NCT00576901|Drug|bevacizumab [Avastin]|15mg/kg iv on day 1 of each 3 week cycle
16309375|NCT00576901|Drug|Docetaxel|75mg/m2 iv on day 1 of each 3 week cycle
16309376|NCT00576901|Drug|Xeloda|2000mg/m2 po on days 1-15 of each 3 week cycle
16309377|NCT00576888|Other|no intervention|no intervention - observational only
16309448|NCT00576355|Behavioral|Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)|IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.
16309451|NCT00576342|Drug|Dorzolamide+timolol ophthalmic solution|
16309378|NCT00576862|Drug|INSULIN GLARGINE|The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.
16309379|NCT00576849|Drug|Balanced HES 130/0.42|Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
16309380|NCT00576849|Drug|Balanced HES 130/0.42|Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
16309381|NCT00576849|Drug|6% HES 130/0.4 prepared in saline solution|Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is <60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is <10 mmHg
16309382|NCT00576836|Biological|Cultured Thymus Tissue Implantation (CTTI)|Thymus tissue (from unrelated donor), thymus donor, and thymus donor's birth mother screened for safety. CTTI was done under general anesthesia. Cultured thymus tissue was implanted into quadriceps. Thymus dose at least 4grams/m2 body surface area (0.2 grams/kg body weight) and not >18 grams/m2 body surface area (1.0 grams/kg body weight). At time of CTTI, skin biopsy was obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy was done to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. (Allograft biopsy not done if subject medically unstable.) Post-CTTI, subjects followed by immune evaluations, using blood samples.
16309383|NCT00576836|Other|Cultured Thymus Tissue Implantation with Parathyroid Transplantation|Parental parathyroid donors screened for eligibility and safety. If both parents meet eligibility criteria, the parathyroid will be harvested from parent who shares the most Human Leukocyte Antigens (HLA) alleles with thymus donor. Parathyroid harvest & transplant preferably done at same time as CTTI. (If parathyroid transplant cannot be done at same time, then it is done within 3-8 weeks of CTTI.) Parathyroid harvest done under general anesthesia. One parathyroid gland is minced & placed in quadriceps muscle; there is no dose in mg. No biopsy done of the parathyroid. Parathyroid donors are monitored as outpatients until recipients' discharge. Recipients' calcium and PTH levels are monitored indefinitely.
16309384|NCT00576823|Drug|Alfuzosin|"Dose: 0.2 mg/kg/day
~Route: oral"
16309385|NCT00576810|Drug|sodium picosulphate|
16309386|NCT00576784|Drug|pioglitazone and glimepiride|switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
16309387|NCT00576771|Procedure|PSV|Pressure Support Ventilation
16309388|NCT00576771|Procedure|NAVA|Neurally Adjusted Ventilatory Assist
16309389|NCT00576771|Procedure|patient-controlled|assisted controlled MV through a button
16309390|NCT00576758|Drug|obinutuzumab (RO5072759)|1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
16309391|NCT00576758|Drug|rituximab|375 mg/m^2 rituximab IV infusion once a week for 4 weeks.
16309392|NCT00576745|Procedure|Vicryl Suture|A 4-0 vicryl suture will be used to close the subcuticular layer
16309393|NCT00576745|Device|3M TM S Surgical Skin Closure System|These steri-strips will be applied to close the skin in this cohort of patients
16309394|NCT00576732|Drug|Placebo|Oral solution qd or bid for 6 weeks
16309395|NCT00576732|Drug|Risperidone high dose|Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) qd or bid for 6 weeks
16309396|NCT00576732|Drug|Risperidone low dose|Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) qd or bid for 6 weeks
16309397|NCT00576719|Behavioral|Intensive panic control treatment without parent involvement|Intensive panic control treatment without parent involvement is an 8-day, intensive form of cognitive behavioral therapy (CBT) with exposure, including 15-20 hours of direct therapist contact. The basic treatment components are psychoeducation about anxiety, restructuring anxiety-provoking thoughts, exposure to bodily sensations that trigger panic, and in vivo exposures.
16309398|NCT00576719|Behavioral|Intensive panic control treatment with parent involvement|Intensive panic control treatment with parent involvement involves the same form of intensive CBT, but with direct parent involvement. Parents will attend the last 30 minutes of didactic sessions, complete homework assignments, learn ways to coach their children, and participate in selected exposures.
16309399|NCT00576719|Other|Waitlist control|Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
16309400|NCT00576706|Drug|Rebamipide|Rebamipide 100㎎, 12 weeks
16309401|NCT00576706|Drug|Misoprostol|Misoprostol 200㎍ 12 weeks
16309402|NCT00576693|Device|intracranial angioplasty and stenting|intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
16309403|NCT00576693|Other|intensive medical management|intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
16309404|NCT00576680|Drug|RAD001|Given orally once a day
16309405|NCT00576680|Drug|Temozolomide|Taken orally once a day for one week followed by a one-week break period
16309406|NCT00576667|Drug|Rimonabant|Tablet, oral administration
16309407|NCT00576667|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16309408|NCT00576654|Drug|Irinotecan Hydrochloride|Given IV
16309409|NCT00576654|Other|Laboratory Biomarker Analysis|Correlative studies
16309410|NCT00576654|Other|Pharmacological Study|Correlative studies
16309411|NCT00576654|Drug|Veliparib|Given PO
16309412|NCT00576641|Biological|autologous dendritic cells|
16309413|NCT00576628|Drug|methoxy polyethylene glycol-epoetin beta [C.E.R.A.]|Recommended starting dose 1.2 micrograms/kg sc monthly
16309414|NCT00576615|Drug|Placebo solution|On the day of the study infusion into the vein of a solution containing no drug, Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion. Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks.
16309415|NCT00576615|Drug|propofol|"On the study day you will receive study drug propofol. Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion.
~Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks."
16309416|NCT00576602|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
16309417|NCT00576602|Drug|Supportive treatment|As prescribed
16309418|NCT00576589|Drug|CE-326,597|CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.
16309419|NCT00576589|Drug|Placebo|CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
16309420|NCT00576576|Drug|Atorvastatin|Atorvastatin 80 mg a day
16309421|NCT00576563|Drug|FDG|contrast medium
16309422|NCT00576550|Drug|Urea|Urea cream applied twice daily up to six months
16309423|NCT00576550|Drug|betamethasone valerate|Application once daily for two weeks
16309424|NCT00576550|Drug|betamethasone valerate|Application twice daily for two weeks
16309425|NCT00576537|Biological|Dendritic Cell Immunotherapy|Patients will receive four vaccines.
16309426|NCT00576524|Device|ITD|ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
16309427|NCT00576524|Device|Sham|Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
16309428|NCT00576511|Drug|prucalopride|4 mg o.d.
16309429|NCT00576511|Drug|placebo|Placebo o.d.
16309430|NCT00576498|Other|NBI-AFI imaging|"Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars.
~Autofluorescence Imaging- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm).In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence."
16309431|NCT00576498|Other|Standard Endoscopy|Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.
16309432|NCT00576485|Procedure|Cataract surgery and intraocular lens implantation|Cataract surgery and implantation of an intraocular lens
16309433|NCT00576472|Drug|Methylphenidate|Please see detailed description for dosing information and study design.
16309434|NCT00576459|Drug|0.59 mg fluocinolone acetonide intravitreal implant|0.59 mg
16309435|NCT00576459|Drug|2.1 mg fluocinolone acetonide intravitreal implant|2.1 mg
16309436|NCT00576459|Procedure|standard of care laser photocoagulation|standard of care laser photocoagulation
16309437|NCT00576446|Biological|Dendritic cell Vaccine|Patients will receive three vaccines every two weeks
16309438|NCT00576433|Drug|Methotrexate|As prescribed
16309439|NCT00576433|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16309440|NCT00576420|Biological|FS VH S/D 500 s-apr, 60-seconds polymerization time|FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
16309441|NCT00576420|Biological|FS VH S/D 500 s-apr, 120-seconds polymerization time|Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
16309442|NCT00576420|Procedure|Manual compression with surgical gauze pads|Treatment of the study suture line with manual compression with surgical gauze pads.
16309443|NCT00576407|Biological|Cultured Thymus Tissue for Implantation (CTTI)|Cultured thymus tissue for implantation (CTTI) (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated thymus donors. Thymus tissue, the thymus donor, & thymus donor's birth mother were screened for safety. Approximately 2-3 weeks post-harvest thymus slices were implanted into the recipient's quadriceps. Dose was number of grams of cultured thymus tissue divided by the recipient's weight in kilograms. Minimum dose was 4 g/m2. Maximum dose 18g/m2. At time of CTTI, a skin biopsy was obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy to evaluate for thymopoiesis & graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. Post-CTTI, subjects followed by routine research immune evaluations, using blood samples for approximately 2 years.
16309444|NCT00576394|Drug|IV Insulin drip|IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
16309445|NCT00576394|Drug|Insulin|IV insulin drip to keep serum glucose between 80-120mg/dl.
16309446|NCT00576381|Drug|Dexmedetomidine|Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
16309449|NCT00576355|Behavioral|Treatment As Usual (TAU)|TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.
16309452|NCT00576329|Drug|Ketorolac|Topical use before surgery
16309453|NCT00576316|Drug|Symbicort Turbuhaler 160/4.5|
16309454|NCT00576303|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv monthly (starting dose)
16309455|NCT00576277|Drug|AV411|
16309456|NCT00576251|Drug|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
16309457|NCT00576251|Drug|TOBRADEX|TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
16309458|NCT00576238|Drug|betamethasone valerate|Topical application according to a fixed schedule for three weeks
16309459|NCT00576238|Drug|betamethasone valerate|Topical application according to a fixed schedule for three weeks
16309460|NCT00576238|Drug|urea|Topical application twice daily for up to 6 months
16309461|NCT00576225|Drug|CT-2103/carboplatin|CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
16309462|NCT00576225|Drug|paclitaxel/carboplatin|Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
16309463|NCT00576212|Behavioral|supportive call|Each subject in the intervention group will receive a 10 minute (or longer) biweekly telephone call from a psychologist intended to provide non-judgemental support to TOPFA women with the aim of reducing depression, guilt, isolation, shame, marital discord, and other common psychological sequelae of termination for fetal anomalies.
16309464|NCT00576199|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid in single-use vials.
16309465|NCT00576199|Procedure|Transarterial chemoembolisation (TACE)|"TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.
~Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE."
16309466|NCT00576173|Drug|tramadol hydrochloride; acetaminophen|
16309467|NCT00576160|Behavioral|PST therapy|Problem-Solving Therapy (PST) is a behavioral approach that teaches patients how to systematically solve their own behavioral difficulties. During telephone treatment sessions, the patient will discuss the problems and difficulties they face and that give rise to medication non-adherence.
16309468|NCT00576147|Device|Infrascanner|The main Near-Infrared spectroscopy (NIRS) head measurement
16309469|NCT00576134|Device|Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing|An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.
16309470|NCT00576108|Drug|KD7040 Topical Gel|KD7040 topical gel
16309471|NCT00576108|Drug|Placebo gel|Placebo gel
16309472|NCT00576082|Other|Cutaneous biopsy|Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
16309473|NCT00576069|Drug|budesonide/formoterol|2 inhalations 2X/daily in treated arm/group. No placebo group
16309474|NCT00576069|Drug|fluticasone/salmeterol|fluticasone 100ug/salmeterol 50ug, 1 inhalation bid noplacebo fluticasone 250ug/salmeterol 50ug, 1 inhalations bid no placebo Spiriva handihaler daily or respihaler 2 inhalations daily no placebo group
16309475|NCT00576069|Drug|mometasone/formoterol|"200/5 mcg two puffs bid 100/5 mcg two puffs bid Breo Ellipta once daily Spiriva capsule handihaler once daily or Spiriva respihaler 2 in
~no placebo group"
16309476|NCT00576069|Drug|Prednisone|0-15 mg daily as needed
16309477|NCT00576056|Drug|Sorafenib|Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
16309478|NCT00576056|Drug|TACE|TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.
16309479|NCT00576043|Procedure|Simulator Training|3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator with the GI-Mentor Virtual simulator device
16309480|NCT00576030|Other|hab cof with water|habitual coffee drinker provided with water
16309481|NCT00576030|Other|hab cof with dec espresso|habitual coffee drinkers given decaffeinated espresso
16309482|NCT00576030|Other|hab cof with caf espresso|habitual coffee drinkers given caffeinated espresso
16309483|NCT00576030|Other|non-hab cof with water|non-habitual coffee drinkers given water
16309484|NCT00576030|Other|non-hab cof with dec espresso|non-habitual coffee drinkers given decaffeinated espresso
16309485|NCT00576030|Other|non-hab cof with caf espresso|non-habitual coffee drinkers given caffeinated espresso
16309486|NCT00576017|Drug|Fentanyl-TTS|
16309487|NCT00576004|Procedure|Pelvic organ prolapse repair and Burch colposuspension|Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
16309488|NCT00575991|Dietary Supplement|Conjugated linoleic acid|3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)
16309489|NCT00575978|Drug|Hydralazine|Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
16309490|NCT00575965|Drug|Simvastatin|Oral tablets taken daily
16309491|NCT00575952|Drug|Cisplatin|Given IV or IP
16309492|NCT00575952|Drug|Doxorubicin Hydrochloride|Given IV
16309493|NCT00575952|Biological|Filgrastim|Given SC
16309494|NCT00575952|Drug|Paclitaxel|Given IV or IP
16309495|NCT00575952|Biological|Pegfilgrastim|Given SC
16309496|NCT00575926|Drug|LingZhi capsule|LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
16309497|NCT00575913|Drug|Alfuzosin|Alfuzosin 10 mg One tablet per day after evening meal
16309498|NCT00575900|Behavioral|dietary intervention|12 weeks of dietary intervention
16309499|NCT00575887|Drug|Temozolomide|100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
16309500|NCT00575874|Drug|Rivoglitazone HCl|0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
16309501|NCT00575874|Drug|rivoglitazone HCl|1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
16309502|NCT00575874|Drug|rivoglitazone HCl|1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
16309503|NCT00575874|Drug|pioglitazone HCl|30 mg capsules once daily for 12 weeks
16309504|NCT00575874|Drug|placebo|matching tablets or capsule once daily for 12 weeks
16309505|NCT00575861|Drug|zileuton|zileuton (Zyflo) 600mg qid for 2hr and for 30 days
16309506|NCT00575848|Dietary Supplement|Glycine|Subjects will consume glycine twice daily, once with breakfast and once with dinner. The medication is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.
16309507|NCT00575848|Dietary Supplement|Placebo|Subjects will consume placebo twice daily, once with breakfast and once with dinner. The placebo is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.
16309508|NCT00575835|Dietary Supplement|vitamin D twice daily|Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
16309509|NCT00575835|Dietary Supplement|Vitamin D3 oil three times in a year|Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year
16309510|NCT00575822|Device|NDO Full-thickness Plicator|A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
16309511|NCT00575822|Device|Sham Control|The sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind.
16309512|NCT00575809|Other|Mucositis and nutritional assessments|Mucositis and nutritional assessments before and during the hematopoietic stem cell transplantation
16309513|NCT00575796|Drug|Vinblastine Sulphate|Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.
16309514|NCT00575744|Procedure|Sentinel Node Biopsy|Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
16309515|NCT00575731|Behavioral|Weight management strategies|
16309516|NCT00575718|Behavioral|Hospital Counseling + Nicotine Replacement Therapy. questionaires|"brief face-to-face or telephone tobacco cessation counseling provided by a tobacco cessation specialist prior to admission and during hospitalization (15-20 minutes per encounter)provision of multi-media self-help materials (e.g., Smoking Cessation Guide for Cancer Patients and Their Families) tailored to address cancer-specific issues such as the benefits and barriers of quitting for cancer patients; 3) tobacco cessation pharmacotherapy, unless medically contraindicated (for this study we will standardize the pharmacotherapy as transdermal nicotine patch), and; 4) two brief telephone counseling (15 minutes) sessions completed as seen clinically appropriate by the tobacco cessation specialists. The content of these counseling sessions is based on the patient's smoking status."
16309517|NCT00575718|Behavioral|Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires|Same components of HC+NRT as well as the PS/SRS enhancement.The research team will provide education about scheduled reduced smoking either in person or over the phone. Purpose of the training session, will be audio taped, to prepare participants for daily PDA use over the dur of the scheduled-reduced smoking intervention. Training will demonstrate use of PDA and simulate common technical and procedural issues that might arise during the intervention (e.g., forgetting to record a cigarette or wake time; repeating a day's schedule if needed, prior to the quit date). The simulation will reflect anticipated problems and those identified by users of the PDA. A study helpline number and instructional manual will be provided. A member of the research staff will contact the study participants, once the reduced smoking schedule has begun, to check that the patient understands the schedule and that the PDA is working properly. Estimate patient training with the PDA will require 30 minutes.
16309518|NCT00575679|Behavioral|Brief motivational interview|The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.
16309519|NCT00575666|Drug|Insulin or Placebo|intranasal, 40IU, 4 times daily
16309520|NCT00575640|Drug|Hydralazine|Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
16309521|NCT00575627|Drug|Peg-Interferon alpha2a plus Ribavirin|Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily
16309522|NCT00575614|Drug|prucalopride|1 mg o.d.
16309523|NCT00575614|Drug|placebo|o.d.
16309524|NCT00575601|Drug|SIMVASTATIN|20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used
16309525|NCT00575588|Drug|Metformin|open-label metformin
16309526|NCT00575588|Drug|Sulphonylurea|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
16309527|NCT00575588|Drug|Saxagliptin|Saxagliptin 5 mg tablets
16309528|NCT00575575|Behavioral|cognitive behavior therapy|cognitive behavior therapy once a week
16309529|NCT00575562|Drug|KRN330|Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
16309530|NCT00575549|Other|Dobutamine: Perflutren Lipid Microsphere|Dobutamine with starting dose of 10 micrograms/kg/min and increased gradually to a maximum dose of 50 micrograms/kg/min Definity will be infused continuously at a rate of 4mL/min
16309531|NCT00575536|Procedure|Rhizotomy for children with spasticity|Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
16309532|NCT00575523|Drug|Atropine|Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
16309533|NCT00575523|Drug|Placebo|1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
16309534|NCT00575510|Behavioral|Intervention|Multiple component intervention based in the unified theory of behavior
16309535|NCT00575510|Behavioral|Active control|Partial intervention (full intervention minus cultural-specific component)
16309536|NCT00575497|Procedure|More frequent hemodialysis|Six Day per week short daily hemodialysis
16309537|NCT00575497|Procedure|More frequent hemodialysis|Six nights per week nocturnal hemodialysis
16309538|NCT00575497|Procedure|More frequent hemodialysis|Every other day short daily hemodialysis
16309539|NCT00575497|Procedure|More frequent hemodialysis|Every other night hemodialysis
16309540|NCT00575497|Procedure|More frequent hemodialysis|5 days per week short daily hemodialysis
16309541|NCT00575497|Procedure|More frequent hemodialysis|5 nights per week hemodialysis
16309542|NCT00575497|Procedure|Conventional Hemodialysis|3 days per week short daily hemodialysis
16309543|NCT00575484|Drug|Hypertonic saline, then oral sodium chloride|2mL/kg hypertonic saline (4.4% NaCl if serum sodium </=135, else 2.8% NaCl) infused over 30min BID and dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) until patient is switched to oral loop diuretic. After switch to oral diuretic, subject will receive oral 0.75gm sodium (NaCL) capsule dosed BID with loop diuretic (latter dose per treating physician) until 60d after discharge.
16309544|NCT00575484|Drug|Normal saline, then oral placebo capsule|20mL normal saline infusion X 30min BID dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction. After switch to oral diuretic, begin oral placebo capsule BID, dosed with loop diuretic (dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction.
16309545|NCT00575471|Drug|Rivoglitazone HCl|0.5 mg tablets once daily for 12 weeks
16309546|NCT00575471|Drug|rivoglitazone HCl|1.0 mg tablets once daily for 12 weeks
16309547|NCT00575471|Drug|rivoglitazone HCl|1.5 mg tablets once daily for 12 weeks
16309548|NCT00575471|Drug|Placebo|Matching placebo tablets once daily for 12 weeks
16309549|NCT00575432|Radiation|diffusion MRI|diffusion MRI
16309550|NCT00575432|Radiation|BOLD MRI|BOLD MRI
16309551|NCT00575432|Other|Clinical Outcome|Clinical outcome
16309552|NCT00575419|Drug|N-acetylcysteine|"Dose Level 1: 150 mg/kg/day
~Dose Level 2: 300 mg/kg/day
~Dose Level 3: 600 mg/kg/day
~Dose Level 4: 900 mg/kg/day
~Dose Level 5: 1200 mg/kg/day"
16309553|NCT00575406|Drug|Rituximab|i.v., 375 mg/m2, d0 or d1 of each treatment cycle
16309554|NCT00575406|Drug|Cyclophosphamide|i.v., 750 mg/m2, d1 of each treatment cycle
16309555|NCT00575406|Drug|Doxorubicin|i.v., 50 mg/m2, d1 of each treatment cycle
16309556|NCT00575406|Drug|liposomal Doxorubicin|i.v., 50 mg/m2, d1 of each treatment cycle
16309557|NCT00575406|Drug|Vincristin|i.v., 2mg, d1 of each treatment cycle
16309558|NCT00575406|Drug|Prednisolone|p.o., 100mg, d1 - d5 of each treatment cycle
16309559|NCT00575393|Drug|gold sodium thiomalate|
16309560|NCT00575393|Genetic|gene expression analysis|
16309561|NCT00575393|Other|fluorine F 18 fluorothymidine|
16309562|NCT00575393|Other|mass spectrometry|
16309563|NCT00575393|Other|pharmacological study|
16309564|NCT00575380|Drug|AzaSite Eye Drops|One drop two times a day for two days and once a day for the next five days.
16309565|NCT00575380|Drug|Vigamox Eye Drops|One drop three times a day for seven days
16309566|NCT00575367|Drug|AzaSite (azithromycin ophthalmic solution)|One drop ophthalmic solution at Visit 2
16309567|NCT00575367|Drug|Vigamox (moxifloxacin hydrochloride ophthalmic solution)|One drop ophthalmic solution at Visit 2
16309568|NCT00575354|Drug|Sevoflurane|3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.
16309569|NCT00575354|Drug|Isoflurane|3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.
16309570|NCT00575341|Drug|Dehydroepiandrosterone|25 mg DHEA, oral, once daily
16309571|NCT00575341|Drug|placebo|placebo, oral, once daily
16309572|NCT00575328|Drug|Maca Root|3g/day of Maca Root for 12 weeks.
16309573|NCT00575328|Drug|Placebo|Placebo provided by research pharmacy daily for 12 weeks.
16309574|NCT00575302|Drug|Gonal-f®: follitropin alpha|Gonal-f®: follitropin alpha, administration of 300 U
16309575|NCT00575302|Drug|Gonal-f®: follitropin alpha|Gonal-f®: follitropin alpha, administration of 450 U
16309576|NCT00575250|Behavioral|Osteoporosis Prevention and Self-Management Course|Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
16309577|NCT00575250|Behavioral|Introductory education session on osteoporosis|Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.
16309578|NCT00575237|Procedure|Recruitment manouver|In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
16309579|NCT00575224|Drug|Pegylated interferon and ribavirin|180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.
16309580|NCT00575198|Other|No drainage threshold|Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
16309581|NCT00575198|Other|Drainage <2 mL/kg|Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
16309582|NCT00575185|Drug|Valomaciclovir|4 grams orally of valomaciclovir (2 grams BID) for 21 days.
16309583|NCT00575185|Drug|placebo|Placebo tablets orally twice daily for 21 days.
16309584|NCT00575159|Drug|GSK189075|investigational drug
16309585|NCT00575159|Drug|placebo|placebo comparator
16309586|NCT00575146|Dietary Supplement|TAVARLIN|ketogenic diet, dietary supplementary products provided by TAVARLIN
16309587|NCT00575120|Other|ischemia reperfusion|reperfusion after a 15 min. lasting cuff induced arm ischemia
16309588|NCT00575107|Other|Exercise|Velocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition
16309589|NCT00575107|Other|Exercise|Standard training of leg extension
16309590|NCT00575094|Drug|tigecycline|Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
16309591|NCT00575081|Device|Stereotactic brain procedures|Stereotactic brain procedures
16309592|NCT00575068|Drug|IDEC-114|Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A & II-B - Dosage start at the MTD (up to 375 mg/m2)
16309593|NCT00575055|Drug|Bapineuzumab 0.5 mg/kg|given by infusion every 13 weeks for a total of 6 infusions.
16309594|NCT00575055|Drug|Placebo Control|given by infusion every 13 weeks for a total of 6 infusions.
16309595|NCT00575055|Drug|Bapineuzumab 1.0 m/kg|given by infusion every 13 weeks for a total of 6 infusions.
16309596|NCT00575042|Drug|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)|160 mg per day for 1 year
16309597|NCT00575029|Drug|megestrol acetate|600 mg by mouth daily
16309598|NCT00575016|Biological|Normal saline (Placebo); botulinum toxin Type A (200U)|Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
16309599|NCT00575016|Biological|botulinum toxin Type A (50U); botulinum toxin Type A (200U)|botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
16309600|NCT00575016|Biological|botulinum toxin Type A (100U); botulinum toxin Type A (200U)|botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
16309601|NCT00575016|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
16309602|NCT00575003|Drug|CYT003-QbG10|6 subcutaneous injections
16309603|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected must be < 10cm.
~Cohort 1: 3 x 10e7 p.f.u. Cohort 2: 1 x 10e8 p.f.u. Cohort 3: 3 x 10e8 p.f.u. Cohort 4: 1 x 10e9 p.f.u. Cohort 5: 3 x 10e9 p.f.u."
16309604|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected must be < 10cm.
~Cohort 1: 3 x 10e7 p.f.u. Cohort 2: 1 x 10e8 p.f.u. Cohort 3: 3 x 10e8 p.f.u. Cohort 4: 1 x 10e9 p.f.u. Cohort 5: 3 x 10e9 p.f.u."
16309605|NCT00574977|Biological|Vaccinia virus (vvDD-CDSR)|"Eligible subjects will receive 1 infusion of vvDD-CDSR.
~Cohort 1: 3 x 10e8 p.f.u; Cohort 2: 1 x 10e9 p.f.u.; Cohort 3: 3 x 10e9 p.f.u."
16309606|NCT00574964|Other|Gliadel Wafer, Temodar and Radiotherapy|Given concurrently starting 10-30 days after surgery.
16309607|NCT00574951|Drug|motesanib diphosphate|
16309608|NCT00574925|Drug|Esomeprazole|
16309609|NCT00574912|Drug|Placebo|single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours
16309610|NCT00574912|Drug|Insulin Glargine 0.5 u/kg body wt SC|8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)
16309611|NCT00574912|Drug|Insulin Glargine 1.0 u/kg body wt SC|
16309612|NCT00574912|Drug|Insulin Glargine 1.5 u/kg body wt SC|
16309613|NCT00574912|Drug|Insulin Glargine 2.0 u/kg body wt SC|
16309614|NCT00574899|Other|Questioners, blood specimens, prostate tissue specimens|"You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
~Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat."
16309615|NCT00574899|Other|Questioners, blood specimens, prostate tissue specimens|"You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
~Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat."
16309616|NCT00574886|Biological|Id-KLH|Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
16309617|NCT00574873|Drug|Bosutinib|500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
16309618|NCT00574873|Drug|imatinib|400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
16309619|NCT00574860|Drug|EN3285|Oral rinse
16309620|NCT00574860|Drug|Placebo|Oral rinse
16309621|NCT00574860|Other|Standard of care|This will be the therapy most commonly used the the institution treating the patient
16309622|NCT00574847|Drug|Escitalopram|Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
16309623|NCT00574847|Drug|Placebo|Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
16309624|NCT00574834|Drug|Ramipril|Ramipril 20 mg once daily for 6 months
16309625|NCT00574834|Drug|HCTZ-hydrochlorothiazide|HCTZ 25 mg once daily for 6 months
16309626|NCT00574834|Drug|Ramipril+HCTZ|Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
16309627|NCT00574808|Other|Outreach Facilitation implementing elements of the Chronic Care Model|"An outreach facilitator helps the practice identify areas for improvement, set goals and targets, and agree on the processes needed to reach them in order to improve the care delivery within the practices. Each facilitator will be assigned up to 12 practice sites. The first year of program implementation will involve frequent (once every 3-4 weeks) visits to the practices. Afterwards, the intervention will move into a sustainability mode, during which the frequency of visits will decrease to one every 6-8 weeks during the second year, and one every 12-15 weeks during the third year and thereafter. After the first year of program implementation, each facilitator will be able to take on 12 new practices during the second year, while still being able to sustain contact with the previous 12 practices. Similarly, in the third year, another set of 12 practices will begin the intense phase of program implementation."
16309628|NCT00574795|Biological|13vPnC|"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
16309629|NCT00574769|Drug|RAD001, Docetaxel, Bevacizumab|"RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily
~Bevacizumab infusion (IV), 15 mg/kg every 21 days
~Docetaxel infusion (IV), 75 mg/m^2 every 21 days"
16309630|NCT00574756|Drug|ranolazine|extended release 500 mg twice a day for two weeks
16309631|NCT00574743|Drug|Enteric-coated Mycophenolate Sodium|
16309632|NCT00574730|Drug|CHOP/Rituximab|"Six cycles of CHOP/Rituximab therapy at 21-day intervals. CHOP chemo will be administered on day 1 after rituximab.
~Cyclophosphamide750mg/m2 IV, Doxorubicin 50mg/m2 IV, Vincristine 1.4mg/m2 (max 2mg) IV, Prednisone 100mg PO daily x 5 days Rituximab 375mg/m2"
16309633|NCT00574730|Drug|PEG INTRON|Pegylated Interferon-alpha 2mg/kg/week for 52 weeks
16309634|NCT00574717|Procedure|Spectacles|Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia.
16309635|NCT00574704|Drug|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)|subcutaneous injections at 6 visits
16309636|NCT00574704|Drug|House dust mite allergen extract in combination with CYT003-QbG10-placebo|subcutaneous injections at 6 visits
16309637|NCT00574704|Drug|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo|subcutaneous injections at 6 visits
16309638|NCT00574704|Drug|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo|subcutaneous injections at 6 visits
16309639|NCT00574691|Device|7F Ensure Medical Vascular Closure Device|Vascular Closure Device
16309640|NCT00574678|Other|Tear collection|"A tear sample (~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an eye wash method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed."
16309641|NCT00574665|Other|Hyperinsulinemic Hyperglycemic Clamp|Glucose Clamp
16309642|NCT00574652|Drug|Proleukin|3 millions IU/day from day 1 to 5 every 21 days will be carried out at W1, W3, W6, and W9)
16309643|NCT00574639|Drug|Alprazolam|1 mg given orally prior to morning and afternoon clamps on Day 1
16309644|NCT00574639|Drug|Placebo|1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)
16309645|NCT00574626|Procedure|PBSCT|Peripheral Blood Stem Cell Transplant
16309646|NCT00574626|Procedure|Bone Marrow Transplant|Bone Marrow Transplant
16309647|NCT00574613|Drug|P144|Cream 0,3 ml once a day (3 months)
16309648|NCT00574613|Drug|placebo|Cream 0,3 ml once a day (3 months)
16309649|NCT00574600|Biological|SAAVI DNA-C2 vaccine|DNA vaccine
16309650|NCT00574600|Biological|SAAVI MVA-C vaccine|Boost vaccine
16309651|NCT00574600|Biological|Placebo|Placebo vaccine
16309652|NCT00574587|Drug|Vorinostat|Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
16309653|NCT00574587|Drug|Paclitaxel|Paclitaxel 80 mg/m2 weekly for 12 weeks
16309654|NCT00574587|Drug|Trastuzumab|Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
16309655|NCT00574587|Drug|Doxorubicin|Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
16309656|NCT00574587|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
16309657|NCT00574587|Procedure|Surgery|Surgical excision of tumor from breast
16309658|NCT00574574|Dietary Supplement|anthocyanin|500mg/d of anthocyanin each day for 12 weeks (84days). Route of administration: oral capsules, 4 X 250mg capsules (125mg anthocyanin/ capsule). Dosage advice; 2 capsules to be taken with food, twice per day (n=4 in total).
16309659|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
16309660|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
16309661|NCT00574548|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
16309662|NCT00574548|Biological|23-valent Pneumococcal Polysaccharide Vaccine|0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
16309663|NCT00574548|Biological|23-valent Pneumococcal Polysaccharide Vaccine|0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
16309664|NCT00574522|Radiation|Far infrared|Far infrared radiation with the wavelength between 5μm and 20μm for 30 to 40 minutes per session.
16309665|NCT00574509|Radiation|131Iodine-Anti-B1 Radioimmunotherapy|Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.
16309666|NCT00574496|Drug|cyclophosphamide|
16309667|NCT00574496|Drug|cyclosporine|
16309668|NCT00574496|Drug|fludarabine phosphate|
16309669|NCT00574496|Drug|gemcitabine hydrochloride|
16309670|NCT00574496|Drug|ifosfamide|
16309671|NCT00574496|Drug|mechlorethamine hydrochloride|
16309672|NCT00574496|Drug|melphalan|
16309673|NCT00574496|Drug|methotrexate|
16309674|NCT00574496|Drug|mycophenolate mofetil|
16309675|NCT00574496|Drug|prednisone|
16309676|NCT00574496|Drug|procarbazine hydrochloride|
16309677|NCT00574496|Drug|vincristine sulfate|
16309678|NCT00574496|Drug|vinorelbine tartrate|
16309679|NCT00574496|Procedure|allogeneic bone marrow transplantation|
16309680|NCT00574496|Procedure|allogeneic hematopoietic stem cell transplantation|
16309681|NCT00574496|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16309682|NCT00574496|Procedure|peripheral blood stem cell transplantation|
16309683|NCT00574496|Procedure|umbilical cord blood transplantation|
16309684|NCT00574496|Radiation|total-body irradiation|
16309685|NCT00574483|Drug|quinacrine|100 mg day
16309686|NCT00574470|Drug|daclizumab, infliximab|Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.
16309687|NCT00574457|Other|Carotid Ultrasound|All subjects that meet the inclusion criteria at each certified site will be invited to participate and go through the same intervention (questionaire-scan-post scan questionaire and 1 month follow up questionaire)
16309688|NCT00574444|Procedure|transvaginal diagnostic peritoneoscopy|For patients with pelvic pain, a transvaginal procedure can be done to explore the abdomen. Entering through the vagina, will hopefully decrease the number of ports in the abdomen and decrease pain and healing time.
16309689|NCT00574431|Other|Data Collection|Collection of patient data before implementation of a nutritional management protocol
16309690|NCT00574431|Other|Nutritional management protocol|Collection of patient data after implementation of a nutritional management protocol
16309691|NCT00574418|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
16309692|NCT00574405|Drug|MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])|MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
16309693|NCT00574405|Device|CSII (Animas Corporation insulin pump, model IR 1200)|CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
16309694|NCT00574392|Device|Multiwavelength and coherence confocal reflectance microscopy (Vivascope 1500m multiwavelength)|Patients will be imaged with the Vivascope 1500m multiwavelength coherence microscope during a single patient visit. The lesion will be photographed with high resolution photography and surface epiluminescence microscopy. The clinically uninvolved site will be imaged in the same manner.
16309695|NCT00574379|Drug|Bilastine|Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
16309696|NCT00574379|Drug|Placebo|Placebo tablets twice daily for 14 days
16309697|NCT00574366|Drug|erlotinib|"Levels:
~1 Erlotinib 50 mg/d
~2 Erlotinib 50 mg/d
~1 Erlotinib 100 mg/d
~2 Erlotinib 100 mg/d
~3 Erlotinib 150 mg/d
~4 Erlotinib 150 mg/d"
16309698|NCT00574366|Drug|RAD001|"Levels
~minus 1: RAD001 2.5 mg/d
~minus 2: RAD001 2.5 every other day
~RAD001 2.5 mg per day
~RAD001 5 mg per day
~RAD001 10 mg per day
~RAD001 10 mg per day"
16309699|NCT00574353|Radiation|Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission|You will be scanned 2 to 3 times on the same day, but you will only be administered one dose of the FMISO tracer. The first scan will last about 30 minutes. Then you will have 1 to 3 hours to wait before you are scanned again. Some patients will undergo a second scan approximately one-and-a-half hours after the start of the first scan. This scan will last about 10 minutes. The final scan will occur between 2-4 hours after the start of the first scan. This final scan will also last about 10 minutes. During the PET scan, you may have a separate i.v. line put into your other arm so that we can take 2 to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how quickly FMISO leaves your blood stream. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken with each subsequent scan.
16309700|NCT00574340|Other|Hyperinsulinemic Hypoglycemic Clamp|all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
16309701|NCT00574314|Other|No Intervention|Participants will be consented.
16309702|NCT00574301|Procedure|Percutaneous Removal and Margin Ablation|Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.
16309703|NCT00574288|Drug|Part 1: Daratumumab|First participant will receive intravenous (injection of a substance into a vein) 0.005 milligram per kilogram (mg/kg) (planned dose) infusion of daratumumab and other participants will receive different doses. The participants will receive 7 full infusions of daratumumab and 2 predose infusions every 2 weeks. The dose of daratumumab will be escalated sequentially and considering the safety and efficacy of dose in Part 1, dose for Part 2 of the study will be decided. A predose infusion of 10% of the full dose of daratumumab will be administered a day before the first 2 full infusions.
16309704|NCT00574288|Drug|Part 2: Daratumumab|In Part 2, the participants will receive dose of daratumumab as determined in part 1 (16 mg/kg) of the study. Participants will receive 8 full infusions at weekly intervals followed by biweekly (every 2 weeks) infusions for 16 additional weeks and monthly infusions until disease progression or unmanageable toxicity, whichever comes first. Predose was dropped at some point in Part 2. A predose infusion of 10 mg daratumumab will be administered on the day before the first full infusion in select cohorts.
16309848|NCT00573313|Drug|S-adenosylmethionine|Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
16309705|NCT00574288|Other|Methylprednisolone|"Pre-dose: Participants (part 1) will receive methylprednisolone 80 mg intravenous (IV) injection 30 minutes to 2 hours before treatment. Participants (part 2) will receive 100 mg methylprednisolone IV 60 minutes to 2 hours before treatment; if a patient experiences no significant infusion-related reactions, the dose of methylprednisolone may be decreased to 50 mg after Visit 4.
~Post-dose: All participants (part 1) will receive 40 mg methylprednisolone orally on the first and the second day after all full infusions. During Part 2, all participants will receive 20-25 mg methylprednisolone orally or equivalent on the first and second days after all full-dose infusions."
16309706|NCT00574288|Other|Dexamethasone|Participants (Part 2) will receive 20 mg dexamethasone intravenous (IV) injection pre-dose, on the first and second days after every full-dose infusions.
16309707|NCT00574275|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
16309708|NCT00574275|Drug|Placebo|4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle
16309709|NCT00574275|Drug|Gemcitabine|1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.
16309710|NCT00574249|Biological|adalimumab|subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
16309711|NCT00574249|Drug|Calcipotriol/Betamethasone Ointment|Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
16309712|NCT00574249|Drug|placebo (vehicle ointment)|Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
16309713|NCT00574236|Drug|PS-341, doxorubicin|bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
16309714|NCT00574223|Drug|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)|subcutaneous injections at 8 visits
16309715|NCT00574223|Drug|House dust mite allergen extract in combination with CYT003-QbG10-placebo|subcutaneous injections at 8 visits
16309716|NCT00574210|Drug|Bilastine|Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
16309717|NCT00574210|Drug|Placebo|Placebo Tablets administered twice per day
16309718|NCT00574197|Drug|Mycophenolate Sodium|1440mg/day (720mg by mouth, twice a day)
16309719|NCT00574171|Drug|lapatinib|1250mg by mouth daily one hour before or after breakfast on a continuous basis.
16309720|NCT00574171|Drug|Capecitabine|2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
16309721|NCT00574145|Procedure|Bio-field energy therapy|Practitioner's hands to influence the human energy field surrounding the patient's body.
16309722|NCT00574145|Procedure|fatigue assessment and management|duration
16309723|NCT00574145|Procedure|psychosocial assessment and care|duration
16309724|NCT00574145|Procedure|quality-of-life assessment|duration
16309725|NCT00574145|Procedure|therapeutic touch|Practitioner's hands to influence the human energy field surrounding the patient's body
16309726|NCT00574132|Drug|Bapineuzumab 0.5 mg/kg|infusion every 13 weeks for a total of 6 infusions
16309727|NCT00574132|Drug|Placebo Control|given by infusion every 13 weeks for a total of 6 infusions.
16309728|NCT00574132|Drug|Bapineuzumab 1.0 m/kg|infusion every 13 weeks for a total of 6 infusions
16309729|NCT00574119|Drug|spironolactone|spironolactone 50 mg daily for 6 months
16309730|NCT00574106|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength)
16309731|NCT00574093|Drug|Ranibizumab; Verteporfin|Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.
16309732|NCT00574080|Drug|Interim/Maintenance Dexamethasone|20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
16309733|NCT00574080|Drug|Induction/Consolidation Dexamethasone|40 mg Days 1-4
16309734|NCT00574080|Drug|Induction/Consolidation Cisplatin|10 mg/m2 by continuous infusion Days 1-4
16309735|NCT00574080|Drug|Induction/Consolidation Adriamycin|10 mg/m2 by continuous infusion Days 1-4
16309736|NCT00574080|Drug|InductionConsolidation Cyclophosphamide|400 mg/m2 by continuous infusion Days 1-4
16309737|NCT00574080|Drug|Induction/Consolidation Etoposide|40 mg/m2 by continuous infusion Days 1-4
16309738|NCT00574080|Drug|Induction Pegfilgrastim|6 mg Days 6 and 13
16309739|NCT00574080|Drug|Transplant 1 Dexamethasone|20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
16309740|NCT00574080|Drug|Transplant 1 Cisplatin|20 mg/m2 by continuous infusion Days -3 and -2
16309741|NCT00574080|Drug|Transplant 1 Adriamycin|20 mg/m2 by continuous infusion Days -3 and -2
16309742|NCT00574080|Drug|Transplant 1 Cyclophosphamide|800 mg/m2 by continuous infusion Days -3 and -2
16309743|NCT00574080|Drug|Transplant 1 Etoposide|80 mg/m2 by continuous infusion Days -3 and -2
16309744|NCT00574080|Drug|Transplant 1 Melphalan|50 mg/m2 Days -2 and -1
16309745|NCT00574080|Drug|Transplant 1 and 2 Pegfilgrastim|6 mg Day +6
16309746|NCT00574080|Procedure|Autologous Peripheral Blood Stem Cell Transplant (ASCT)|Day 0
16309747|NCT00574080|Drug|Transplant 2 Carmustine|300 mg/m2 Day -5
16309748|NCT00574080|Drug|Transplant 2 Etoposide|200 mg/m2 Days -5, -4, -3, -2
16309749|NCT00574080|Drug|Transplant 2 Cytarabine|400 mg/m2 Days -5, -4, -3, -2
16309750|NCT00574080|Drug|Transplant 2 Melphalan|140 mg/m2 Day -1
16309751|NCT00574080|Drug|Transplant 2 Dexamethasone|20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
16309752|NCT00574080|Drug|Transplant 1 and 2 Bortezomib|1 mg/m2 Days -4, -1, +3, +7
16309753|NCT00574080|Drug|Transplant 1 and 2 Thalidomide|200 mg Days -4 to +5
16309849|NCT00573313|Drug|Placebo|Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
16309754|NCT00574067|Drug|Buprenorphine +OTP|Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
16309755|NCT00574067|Drug|Buprenorphine +CHC|Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
16309756|NCT00574067|Drug|Counseling +OTP|Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
16309757|NCT00574067|Drug|Counseling +CHC|Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
16309758|NCT00574054|Radiation|Far Infrared|Far infrared radiation (5 μm to 20 μm wavelength) for 30 to 40 minutes per treatment session.
16309759|NCT00574041|Drug|Interferon beta-1a|injected, once a week
16309760|NCT00574015|Drug|hydrocodone/acetaminophen|oral hydrocodone 10 mg/acetaminophen 650 mg
16309761|NCT00574015|Drug|bupivacaine (supraperiosteal nerve block)|Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
16309762|NCT00573989|Drug|erlotinib hydrochloride|
16309763|NCT00573989|Drug|pemetrexed disodium|
16309764|NCT00573989|Procedure|quality-of-life assessment|
16309765|NCT00573989|Radiation|intensity-modulated radiation therapy|
16309766|NCT00573963|Drug|ropivacaine|2 injections of 20mL 0.375% ropivacaine - one given on each side.
16309767|NCT00573963|Drug|saline solution|2 injections of 20mL plain saline solution - one on each side.
16309768|NCT00573950|Drug|cilostazol|50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
16309769|NCT00573950|Drug|Placebo|Placebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks
16309770|NCT00573937|Drug|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
16309771|NCT00573937|Drug|Morphine|Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
16309772|NCT00573924|Drug|Proton pump inhibitor (lansoprazole)|"120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs
~90 mg IV bolus followed 9 mg/hr infusion for 24 hrs"
16309773|NCT00573911|Procedure|Endoscopy and pH study|endoscopy and PH study done one time
16309774|NCT00573885|Drug|defined green tea catechin extract|Given orally
16309775|NCT00573885|Other|placebo|Given orally
16309776|NCT00573872|Radiation|Radiosurgery|"Phase I: 20-25 Gy in 5 fractions
~Phase II: 9-24 GY in 1 fraction"
16309777|NCT00573859|Drug|ADHD medication|For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
16309778|NCT00573859|Drug|Placebo|For the placebo condition, participants received placebo pills for two consecutive days.
16309779|NCT00573833|Other|questionnaire administration|
16309780|NCT00573833|Procedure|quality-of-life assessment|
16309781|NCT00573833|Radiation|brachytherapy|
16309782|NCT00573820|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each treatment session.
16309783|NCT00573807|Radiation|Far Infrared Radiation (5μm to 20μm wavelength)|Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.
16309784|NCT00573794|Biological|adalimumab|adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
16309785|NCT00573781|Dietary Supplement|Diet with increased intake of rye bread, berries and fish|Dietary modification with commercial food items
16309786|NCT00573781|Dietary Supplement|Increased intake of whole grain and rye bread|Dietary modification with commercial food items
16309787|NCT00573781|Dietary Supplement|Control diet with decreased intake of rye bread, berries and fish|Dietary modification with commercial food items
16309788|NCT00573768|Drug|Diclofenac diethylamine 2.32% gel|Diclofenac diethylamine 2.32% gel twice daily
16309789|NCT00573768|Drug|Placebo|Vehicle 2 times daily
16309790|NCT00573768|Drug|Diclofenac diethylamine 2.32% gel / Placebo|Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
16309791|NCT00573755|Drug|anastrozole|given orally
16309792|NCT00573755|Drug|exemestane|given orally
16309793|NCT00573755|Drug|letrozole|given orally
16309794|NCT00573755|Drug|sorafenib tosylate|given orally
16309795|NCT00573755|Other|placebo|given orally
16309796|NCT00573742|Drug|Candesartan Cilexeotil 16mg|
16309797|NCT00573729|Other|Pulsed Dye Laser 577 nm|Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
16309798|NCT00573729|Other|Pulsed Dye Laser 595 nm|Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
16309799|NCT00573703|Procedure|Laparoscopic Burch colposuspension|Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.
16309800|NCT00573703|Procedure|Transobturator tape procedure|Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.
16309801|NCT00573690|Drug|carboplatin|Given IV
16309802|NCT00573690|Drug|cisplatin|Given IV
16309803|NCT00573690|Drug|etoposide|Given IV
16309804|NCT00573690|Drug|pemetrexed disodium|Given IV
16309805|NCT00573690|Drug|sorafenib tosylate|Given orally
16309806|NCT00573664|Drug|Gabapentin|single oral dose of 600mg gabapentin
16309807|NCT00573664|Other|lactose|Single dose
16309808|NCT00573651|Other|Blood Draws for Serum Titers|All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.
16309809|NCT00573638|Device|Xal-Ease device to be used with Xalatan eye drops|This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.
16309810|NCT00573612|Behavioral|Attention Control Counseling|Subjects will receive educational-based telephone counseling regarding fibromyalgia.
16309811|NCT00573612|Behavioral|Motivational Interviewing|Subjects will receive Motivational Interviewing telephone counseling.
16309812|NCT00573599|Drug|prochlorperazine and benadryl IV|prochlorperazine and benadryl IV, saline subQ
16309813|NCT00573599|Drug|Imitrex SubQ, saline IV|Imitrex SubQ, saline IV
16309814|NCT00573586|Device|Sonablate 500 (SB-500)|Sonablate 500 (SB-500)
16309815|NCT00573573|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
16309816|NCT00573560|Device|VPD Implant System|Percutaneous introduction using standard catheterization techniques of the VPD Implant.
16309817|NCT00573547|Drug|Fluoxetine|Fluoxetine will be dosed at 90 mg once a week
16309818|NCT00573534|Drug|Vyvanse|Patients will be titrated from 30 mgs to 50 mgs to 70 mgs over four weeks, as tolerated and as needed to control ADHD symptoms
16309819|NCT00573508|Drug|Placebo|Oral Administration
16309820|NCT00573508|Drug|Solifenacin Succinate|Oral Administration
16309821|NCT00573495|Biological|hTERT/Survivin Multi-Peptide Vaccine|100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations
16309822|NCT00573482|Behavioral|REDE|"The intervention group received the education in REDE techniques.
~The intervention in this study comprised four components:
~Four group education sessions to introduce the REDE principles of eating;
~Approximately 10 new lower energy-dense foods were introduced in the employee cafeteria daily at lunchtime;
~Food labels for all foods sold in the employee cafeteria at lunch time, which provided the energy density, calories, and macronutrient content of the prepared cafeteria foods. Prior to the intervention almost no foods had food labels.
~Price reductions for lower energy density items. Both groups were exposed to the food labels and the new lower ED foods, but only the intervention group received the education sessions about how to take advantage of the new labels and cafeteria foods and only they were eligible for the price reductions."
16309823|NCT00573482|Behavioral|control|The control group received no REDE intervention at all. Both groups were exposed to the food labels and the new lower ED foods, but the control group did not receive the education sessions.
16309824|NCT00573469|Drug|D9421-C, 9mg|D9421-C 9 mg was given once daily for 8 weeks.
16309825|NCT00573469|Drug|D9421-C, 15mg|D9421-C 15 mg was given once daily for 8 weeks.
16309826|NCT00573469|Drug|Placebo|D9421-C matching placebo was given once daily for 8 weeks.
16309827|NCT00573456|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes per session.
16309828|NCT00573443|Drug|dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg|Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
16309829|NCT00573443|Drug|dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg|Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
16309830|NCT00573443|Drug|Placebo|Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
16309831|NCT00573430|Drug|Candesartan Cilexetil|8 mg oral once daily dose
16309832|NCT00573430|Drug|Candesartan Cilexetil|16 mg oral once daily dose
16309833|NCT00573430|Drug|Candesartan Cilexetil 32mg|32 mg oral once daily dose
16309834|NCT00573417|Drug|modafinil|modafinil 100mg tablets. dose excalation up to 300mg
16309835|NCT00573417|Drug|Placebo|
16309836|NCT00573404|Drug|imatinib mesylate|will start at 200 mg daily and will be escalated up to 400 mg bid.If the 400 mg bid dose is tolerated, no further dose escalation will be performed. In the case of excessive toxicity on the starting dose, the option for de-escalation is provided. Sunitinib will start at 25 mg daily and if tolerated, will be escalated to 37.5 mg daily for subsequent dose levels.
16309837|NCT00573404|Drug|sunitinib malate|
16309838|NCT00573404|Other|pharmacological study|
16309839|NCT00573391|Drug|Velcade, Thalidomide, and Dexamethasone|"Velcade - Into vein (IV) Days 1, 4, 8, 11
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles
~Thalidomide - By Mouth Days 1-28
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles"
16309840|NCT00573391|Drug|Velcade, Melphalan, and Dexamethasone|"Velcade - Into vein (IV) Days 1, 4, 8, 11
~Yr 1: Every 28-35 days-12 cycles
~Yr 2: Every 8-10 weeks- 6 cycles"
16309841|NCT00573378|Drug|PEG-IFN-a2b|Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections.
16309842|NCT00573365|Device|Gentlewaves Select™ handheld high energy LED array|LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment
16309843|NCT00573365|Radiation|Radiation|Weekly radiation treatment
16309844|NCT00573365|Radiation|Radiation|Weekly radiation treatment
16309845|NCT00573352|Radiation|Far Infrared|Far Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session
16309846|NCT00573339|Other|Cardiac MRI|up to 3 Cardiac MRI scans per participant in 1-4 months
16309847|NCT00573326|Drug|Imatinib|200 mg p.o. once a day for 6 months
16309850|NCT00573300|Procedure|Phlebotomy|Single blood draw
16309851|NCT00573287|Drug|clozapine|clozapine--tabs, 450mg. max, daily, 24 weeks
16309852|NCT00573287|Drug|risperidone|risperidone--tabs, 6mg max, daily, 24 weeks
16309853|NCT00573274|Device|Physioflow Impedance|6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).
16309854|NCT00573261|Drug|Pregabalin|Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
16309855|NCT00573261|Drug|Placebo|Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
16309856|NCT00573248|Drug|Nicotine|"21 mg nicotine patches for smokers for 2 days
~7 mg nicotine patches for nonsmokers for 2 days"
16309857|NCT00573248|Other|Placebo|Placebo Patch
16309858|NCT00573222|Drug|Symbicort|
16309859|NCT00573209|Radiation|Far Infrared Radiation|Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
16309860|NCT00573196|Radiation|Far infrared|Far infrared radiation (5μm to 15μm wavelength)
16309861|NCT00573183|Behavioral|STAGE-12|The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.
16309862|NCT00573183|Behavioral|Treatment as Usual|
16309863|NCT00573170|Drug|TREXIMET®|Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg)
16309864|NCT00573170|Drug|Butalbital-containing Combination Medications (BCM)|butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]
16309865|NCT00573170|Drug|placebo|placebo
16309866|NCT00573157|Drug|Atacicept|Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
16309867|NCT00573157|Drug|Mycophenolate mofetil|MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
16309868|NCT00573157|Drug|Placebo|Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
16309869|NCT00573157|Drug|Corticosteroids|High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
16309870|NCT00573144|Drug|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
16309871|NCT00573144|Drug|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator)
16309872|NCT00573131|Drug|OncoGel (Paclitaxel gel)|6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
16309873|NCT00573131|Drug|cisplatin|75 mg/m2 IV (in the vein) once on Day 1 and Day 29
16309874|NCT00573131|Drug|5-FU|1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
16309875|NCT00573131|Radiation|radiation therapy|50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
16309876|NCT00573131|Procedure|esophageal resection|Removal of esophagus after completion of chemotherapy and radiation therapy
16309877|NCT00573105|Procedure|Laparoscopic Ventral hernia repair by heavy weight mesh|Laparoscopic Ventral hernia repair by heavy weight mesh
16309878|NCT00573105|Procedure|Laparoscopic Ventral hernia repair by lighter weight mesh|Laparoscopic Ventral hernia repair by lighter weight mesh
16309879|NCT00573066|Drug|Dexmedetomidine|Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
16309880|NCT00573053|Other|Oxygen saturation range|Maintain functional oxygen saturation range between 91 and 95%
16309881|NCT00573053|Other|Oxygen saturation range|Maintain functional arterial oxygen saturations in the range of 85- 89%
16309882|NCT00573027|Procedure|noninvasive tests|clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.
16309883|NCT00573014|Other|Cervical Spine Clearance|All OBTPs with gross movement of all four extremities admitted to MetroHealth Medical Center who underwent a CT CS at MHMC between October 2006 and September 2008 will be included. Prospective data will be collected on these patients including age, gender, mechanism of injury, Glasgow Coma Scale (GCS) on admission, results of CT CS, GCS at the time of collar clearance, day of collar clearance, collar complications, date of reexamination, and results of reexamination. We will define an obtunded patient as a patient who was unable to reliably describe the presence or absence of CS symptoms in the opinion of the examining physician. Patients needed to have gross movement of all four extremities to be included in the study. We defined cervical collar complications as skin breakdown identified either by the skin care team during weekly rounds in the intensive care unit or by the treating physician at any time.
16309884|NCT00573001|Drug|Tenofovir/Emtricitabine (Truvada) and Nevirapine|Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days
16309885|NCT00573001|Drug|Tenofovir/Emtricitabine/Efavirenz (Atripla)|Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
16309886|NCT00573001|Drug|Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)|Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
16309887|NCT00573001|Drug|Tenofovir/Emtricitabine (Truvada) and Zidovudine|Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
16309888|NCT00572975|Other|Pentadecanoic acid (PA) and Triheptadecanoin (THA)|"Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption.
~in breakfast shake x1"
16309889|NCT00572962|Procedure|use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair|use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
16309890|NCT00572936|Drug|Latanoprost|prostaglandin
16309891|NCT00572936|Drug|Dorzolamide|carbonic anhydrase inhibitor
16309892|NCT00572936|Drug|Timolol|beta blocker
16309893|NCT00572910|Biological|Comparator: Placebo (PBO)|Group 6: Placebo (PBO / PBO / PBO)
16309894|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
~Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA"
16309895|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
~Group 4B: V710 (60 mcg / PBO / PBO) with MAA"
16309896|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
~Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA"
16309897|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
~Group 2B: V710 (60 mcg / PBO / PBO) without MAA"
16309898|NCT00572910|Biological|V710 Comparator: Placebo (PBO)|"Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
~Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA"
16309899|NCT00572897|Drug|Fludarabine, Melphalan +/- ATG|"Conditioning regimen for Allogenic Stem Cell Transplant:
~Related Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily)
~Unrelated Donor Fludarabine days -6 to -2 (30mg/m2 IVPB over 30 minutes daily) Melphalan days -3 to -2 (70mg/m2 IVPB over 30 minutes daily) ATG (Thymoglobulin®) days -3 to -1 (0.5 mg/kg IV on day -3 [given over 6 hours], and 2 mg/kg on days -2 and -1 [given over 4 hours])"
16309900|NCT00572884|Other|permethrin insecticide|25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14
16309901|NCT00572871|Other|plyometric exercise|single bout of plyometric exercise
16309902|NCT00572871|Other|resistance exercise|single bout of resistance exercise
16309903|NCT00572871|Other|No exercise|Will not do any exercise
16309904|NCT00572858|Procedure|Blood test|for cholesterol, glucose and insulin levels and levels of various hormones, including but not limited to estrogen
16309905|NCT00572858|Genetic|Blood test|Blood test for genetic testing
16309906|NCT00572858|Procedure|Ultrasound of neck arteries|Non-invasive test using ultrasound waves to measure the thickness of the arteries
16309907|NCT00572858|Procedure|Saliva test|Saliva test for cotisol levels
16309908|NCT00572845|Other|Weaning of Antispasticity Medication|Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.
16309909|NCT00572832|Biological|Quadrivalent human papillomavirus vaccine on-time administration|The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
16309910|NCT00572832|Biological|Quadrivalent human papillomavirus vaccine delayed administration|The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
16309911|NCT00572819|Drug|Misoprostol|1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
16309912|NCT00572819|Drug|Placebo|Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
16309913|NCT00572806|Drug|insulin aspart|
16309914|NCT00572767|Drug|Dextro-Amphetamin|After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
16309915|NCT00572767|Other|Glucose|"After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
~The treatment of the control group will be the same as for the experimental group except the content of the drug capsule."
16309916|NCT00572754|Procedure|Circumcision|Circumcision by tying a ligature around the foreskin.
16309917|NCT00572741|Dietary Supplement|B12|Methylcobalamin Dose: 75 μg/kg every 3 days
16309918|NCT00572741|Dietary Supplement|Placebo|cellulose
16309919|NCT00572741|Dietary Supplement|folate|Folinic acid: Dose: 400 µg twice a day (BID)
16309920|NCT00572741|Dietary Supplement|B complex|B-Complex: B-1 (3 mg); B-2 (3.4 mg); B-352 (20 mg); B-6 (4 mg;) Pantothenic Acid(10 mg); Biotin (300 mcg); pyridoxal (25mg)
16309921|NCT00572741|Dietary Supplement|vitamin C|Vitamin C 500 mg
16309922|NCT00572741|Dietary Supplement|cod liver oil|Cod liver oil 1/2 teaspoon
16309923|NCT00572741|Dietary Supplement|Mineral complex|Magnesium citrate (200 mg); Selenium (50 mcg); Zinc picolinate (25 mg); Molybdenum (50 mcg); Calcium citrate (400 mg)
16309924|NCT00572741|Dietary Supplement|carnitine|Acetyl L-Carnitine Dose: 250 mg
16309925|NCT00572728|Procedure|CT|Undergo 18F-FLT PET/CT
16309926|NCT00572728|Drug|18F-FLT|Undergo 18F-FLT PET/CT
16309927|NCT00572728|Procedure|PET|Undergo 18F-FLT PET/CT
16309928|NCT00572702|Procedure|Vaginal fixation Amreich-Richter|Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
16309929|NCT00572702|Procedure|Prolift total|Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
16309930|NCT00572689|Drug|Exenatide|10 microgram injected sub-cutaneously once
16309931|NCT00572689|Genetic|Buccal/blood Sample Collection|Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing
16309932|NCT00572663|Drug|ACC (N-acetylcysteine) 1200 mg|N-acetylcysteine (ACC) 1200 mg In the 8-weeks run-in period angiotensin converting enzyme inhibitors and/or angiotensin II subtype 1 receptor antagonists were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 1200 mg N-acetylcysteine in two active treatment periods lasting 8 weeks each
16309933|NCT00572650|Drug|vildagliptin|16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.
16309934|NCT00572637|Drug|CEP-18770|Administered as intravenous infusion on days 1, 4, 8, and 11 of a 21-day cycle up to 6 cycles. Starting dose 0,1 mg/sqm
16309972|NCT00572455|Drug|PF-04217329 - Middle Dose|Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
16309973|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
16309935|NCT00572624|Behavioral|Diet|Participants attended 20 group behavioral modification sessions led by a behaviorist, a registered dietician, and a physical therapist. The meal plans ranged from 1200 to 1500 kilocalories per day, depending on subject sex and BMI, and were designed to achieve ≤1% body weight loss/week. Participants completed daily food records, and were taught a variety of weight management skills. The exercise component included strength, flexibility, balance, and endurance instruction, gradually increasing to 30 minutes of exercise 5 days/week.
16309936|NCT00572624|Procedure|Gastric bypass surgery|The same surgeon performed all bypass procedures using standard techniques. A small (~20 ml) proximal gastric pouch was created by stapling the stomach, and a 75-cm Roux-en-Y limb was constructed by transecting the jejunum distal to the ligament of Treitz, and creating a jejunojejunostomy 75 cm distal to the transection.
16309937|NCT00572611|Drug|[14C]-bilastine|Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
16309938|NCT00572598|Drug|4- [F-18] fluoropaclitaxel|4- [F-18] fluoropaclitaxel, <84 micrograms, <10 mCi, IV followed by PET/CT imaging
16309939|NCT00572585|Drug|AEB071|
16309940|NCT00572585|Drug|Placebo|
16309941|NCT00572572|Drug|Aprepitant|Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
16309942|NCT00572572|Drug|Placebo|Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
16309943|NCT00572559|Drug|Vancomycin|1 gram IV every 12 hours for 7 to 14 days
16309944|NCT00572559|Drug|Linezolid|600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days
16309945|NCT00572533|Other|ESA Dose Adjustment per standard Anemia Management Protocol|Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
16309946|NCT00572533|Other|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"|"Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by Smart Anemia Manager algorithm"
16309947|NCT00572520|Behavioral|Weight loss treatment|Over 2 years, this treatment involves a total of 26 group visits and 10 individual visits with a health education counselor. Group visits, led by a registered dietitian and a licensed exercise physiologist, will target diet and physical activity.
16309948|NCT00572520|Behavioral|Behavior therapy for depression|Behavior therapy for depression will be delivered by a trained behavior therapist. Participants receiving behavioral counseling will learn about depression, links between activity and mood, and will be asked to keep a diary of moods and activities.
16309949|NCT00572520|Behavioral|Health education counseling|Health education counseling will be delivered by a trained health education counselor. Participants receiving health education will learn about women's health topics and receive tips on staying healthy and preventing disease.
16309950|NCT00572507|Device|MonoMax®|Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy
16309951|NCT00572494|Device|MAGIC EXPLORER (Biotronik AG)|The lesion is pre-dilated with the PLEON EXPLORER balloon with a length of 10 mm or 15 mm or 20 mm under angiographic control. After dilation, the stenosed area is treated by one AMS implant. If the implanted stent is not fully apposed to the vessel wall or if initial angiography reveals a residual stenosis, the stent may be post-dilated with the delivery system balloon. If necessary, a high-pressure, non-compliant balloon catheter may be used.
16309952|NCT00572494|Device|PLEON EXPLORER (Biotronik AG)|The lesion is dilated with the PLEON EXPLORER balloon with lengths of 10 mm or 15 mm or 20 mm, respectively. In case that the PTA procedure results in a residual stenosis of >50%, the AMS implant should be used to improve the result. A flow-limiting dissection does not qualify for stenting. Best effort must be made to obtain a satisfactory result (e.g. multiple and prolonged inflations) before a patient in the PTA group can be treated with a stent.
16309953|NCT00572481|Procedure|Axillary Reverse Mapping|During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
16309954|NCT00572468|Drug|Simvastatin|40 mg of simvastatin
16309955|NCT00572468|Other|Placebo|placebo
16309956|NCT00572455|Drug|PF-04217329 - Lowest Dose|1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
16309957|NCT00572455|Drug|PF-04217329 - Low Dose|1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
16309958|NCT00572455|Drug|PF-04217329 - Middle Dose|1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
16309959|NCT00572455|Drug|PF-04217329 - High Middle Dose|1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
16309960|NCT00572455|Drug|PF-04217329 - High Dose|1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
16309961|NCT00572455|Drug|PF-4217329 - Highest Dose|1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
16309962|NCT00572455|Drug|PF-04217329 - Vehicle|1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
16309963|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
16309964|NCT00572455|Drug|PF-04217329 - Low Dose|Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
16309965|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
16309966|NCT00572455|Drug|PF-04217329 - Middle Dose|Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
16309967|NCT00572455|Drug|Latanoprost Vehicle|1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
16309968|NCT00572455|Drug|PF-04217329 - High Dose|Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
16309969|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
16309970|NCT00572455|Drug|PF-04217329 - Low Dose|Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
16309971|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
16309974|NCT00572455|Drug|PF-04217329 - High Dose|Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
16309975|NCT00572455|Drug|Latanoprost 0.005%|1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
16309976|NCT00572455|Drug|PF-04217329 - Vehicle|Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
16309977|NCT00572429|Dietary Supplement|l-carnitine|3 gram daily dose
16309978|NCT00572416|Behavioral|Individual Sleep Promotion Plan|Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene
16309979|NCT00572416|Behavioral|Healthy Eating Control|Equal time and attention and information about healthy eating
16309980|NCT00572390|Drug|oestrogen|Cyclic oestrogen substitution therapy
16309981|NCT00572377|Drug|FemLife Gel|the gel or placebo (240 mcg)applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
16309982|NCT00572377|Drug|Placebo|the gel or placebo (240 mcg) applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
16309983|NCT00572364|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16309984|NCT00572351|Other|Red Wine|8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
16309985|NCT00572351|Other|White Wine|8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
16309986|NCT00572338|Other|No drugs are involved|No treatment or drugs are involved in this research. Participating in this study requires that blood and bone marrow samples be obtained as a part of the diagnostic work-up or follow-up of participant's multiple myeloma. Bone marrow/peripheral blood samples will be collected at the same time for research purposes. Data will be collected including demographic information gathered from your medical record, including gender, date of birth, ethnicity, date of diagnosis, laboratory and pathology results, treatment protocols, dates of relapses, subsequent treatment protocols, and current treatments and medications.
16309987|NCT00572312|Drug|atorvastatin (Sortis) 40 mg|In the 8-weeks run-in period angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor blockers were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 40 mg of atorvastatin in two active treatment periods lasting 8 weeks each
16309988|NCT00572299|Drug|alendronate|70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months
16309989|NCT00572260|Drug|daptomycin 6 mg/kg IV|daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)
16309990|NCT00572247|Behavioral|Psychiatric Rehabilitation Approach to Weight Loss|The use of psychiatric rehabilitation as a way to lose weight
16309991|NCT00572234|Drug|bupropion SR|12 week course of bupropion SR 150 mg, BID
16309992|NCT00572221|Behavioral|Continuing Quality Improvement and Quality Assurance system|The main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation.
16309993|NCT00572221|Behavioral|CQI and QA System with Best-Practice Care Protocols|A facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions.
16309994|NCT00572208|Drug|Gabapentin group|"Gabapentin group:
~Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)
~st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
~th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)"
16309995|NCT00572195|Device|RNS® System|The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
16309996|NCT00572182|Drug|MK-0752|This is a dose escalation study. Patients may receive 150, 200, 260 or 325 mg/m2 orally for 3 consecutive days of every 7 days for 28 days (dosing regimen 1 - closed to accrual 2/23/2010) or 800, 1000, 1400, or 1800 mg/m2 orally once weekly for 28 days (1 course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 6 courses.
16309997|NCT00572169|Drug|Velcade|Will be given in central venous catheter
16309998|NCT00572169|Drug|Thalidomide|Capsule taken by mouth
16309999|NCT00572169|Drug|Dexamethasone|A pill taken by mouth
16310000|NCT00572169|Drug|Adriamycin|Given into the vein (IV) by a continuous infusion through a central catheter
16310001|NCT00572169|Drug|Cisplatin|Given into the vein (IV) by a continuous infusion through a central catheter
16310002|NCT00572169|Drug|Cyclophosphamide|Given into the vein (IV) by a continuous infusion through a central catheter
16310003|NCT00572169|Drug|Etoposide|Given into the vein (IV) by a continuous infusion through a central catheter
16310004|NCT00572156|Drug|NutropinAq® (Somatropin [rDNA origin])|rhGH (Somatropin) 45µg/kg once daily injection
16310005|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
16310006|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
16310007|NCT00572156|Drug|Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])|rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
16310008|NCT00572143|Other|ca coli follow-up by GP|patients randomized to follow up by GP
16310009|NCT00572130|Genetic|Rexin-G Dose 1|Rexin-G i.v., 1 x 10e11 cfu, two times a week x 4 weeks, rest 2 weeks May be repeated if grade 1 or less toxicity
16310010|NCT00572130|Genetic|Rexin-G Dose 2|Rexin-G i.v., 1 x 10e11 cfu, three times a week x 4 weeks; rest 2 weeks May repeated if grade 1 or less toxicity
16310011|NCT00572117|Drug|Topiramate|Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
16310012|NCT00572104|Other|resistance exercise|12 month training intervention of weight resistance exercise. All participants receive a daily calcium and vitamin D supplement
16310013|NCT00572104|Other|plyometric exercise|12 month training intervention of plyometric exercise. All participants receive a daily calcium and vitamin D supplement
16310014|NCT00572091|Device|PTMA Implant|Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
16310015|NCT00572078|Drug|Sorafenib|Cohort 1 200 mg po BID D1-5; Cohort 2 200 mg po BID; Cohort 3 400 mg po BID D1-5 Cohort 4 400 mg po BID
16310016|NCT00572065|Drug|arsenic trioxide|"Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO.
~Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated."
16310017|NCT00572065|Drug|cytarabine|"Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Trisenox will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO.
~Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated."
16310018|NCT00572052|Device|NovoFine® needle 6 mm|
16310019|NCT00572052|Device|Ultra-Fine needle 12.7 mm|
16310020|NCT00572039|Behavioral|PST|PST will be delivered in subjects' homes over the course of 6 weeks.
16310021|NCT00572039|Behavioral|ST|ST will be delivered in subjects' homes over the course of 6 weeks.
16310022|NCT00572026|Drug|Methylphenidate Transdermal System|Daytrana wear time up to 15 hours
16310023|NCT00572013|Drug|Rituxan|375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
16310024|NCT00572013|Drug|BEAM|BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1
16310025|NCT00572013|Procedure|Autologous stem cell transplant|following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
16310026|NCT00572000|Biological|HPV-16/18 L1 VLP AS04 vaccine|Representation: 0.5ml monodose vials Administration: intramuscular Schedule: 0, 1, 6 month
16310027|NCT00571987|Device|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)|Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
16310028|NCT00571974|Device|PDL-585, ScleroPLUS laser|PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue
16310029|NCT00571974|Drug|5-Aminolevulinic Acid (Levulan KerastickTM)|Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze
16310030|NCT00571974|Procedure|Fluorescence Diagnosis Imaging|FD Image taken prior to PDL-585 usage
16310031|NCT00571961|Drug|Kaletra (lopinavir/ritonavir)|4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study
16310032|NCT00571961|Drug|buprenorphine|Buprenorphine will be obtained through prescription at the subject's drug treatment program.
16310033|NCT00571961|Other|Clinical evaluations/Blood draws|Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (blood chemistry and blood counts), PK blood draws.
16310034|NCT00571948|Other|more meat and a vegetable oil rich in omega-3 fatty acids|"The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month.
~The intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids)."
16310035|NCT00571948|Other|Babyfood with usual meat content and corn oil|The active comparator (which is the control group) got babyfood with usual meat content (8%) and with corn oil, which is rich in omega 6 linoleic acid
16310036|NCT00571935|Drug|insulin aspart|
16310037|NCT00571935|Drug|soluble human insulin|
16310038|NCT00571922|Drug|Acamprosate|2 gr/day (333 mg, TID)
16310039|NCT00571922|Drug|placebo|matching placebo
16310040|NCT00571909|Procedure|video thorascopic splanchnicectomy (VSPL)|VSPL is a minimally invasive technique using 1-2cm incisions through which a camera and surgical tools are placed inside the thoracic cavity and the idea of the procedure is to cut the pain pathway linking the splanchnic ganglion with pain centers in the hypothalamus
16310041|NCT00571896|Drug|Senna+ docusate|Senna+Docusate: dose will be 8.6 mg senna concentrate with 50 mg docusate. The participants will take the medication as follows: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
16310118|NCT00571402|Behavioral|Enhanced care|Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
16310042|NCT00571896|Drug|placebo|Placebo pill: The participants will use the placebo pills in the following manner: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
16310043|NCT00571883|Other|questionnaire administration|
16310044|NCT00571883|Procedure|psychosocial assessment and care|
16310045|NCT00571883|Procedure|quality-of-life assessment|
16310046|NCT00571883|Procedure|regional lymph node dissection|
16310047|NCT00571883|Procedure|therapeutic conventional surgery|
16310048|NCT00571870|Drug|cetrorelix acetate|The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF. When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected. In Group A, the GnRH antagonist continued to be used until the day of hCG administration. In Group B, the GnRH antagonist was not administrated on the hCG day
16310049|NCT00571844|Behavioral|DASH diet|Participants in the DASH diet condition receive instruction in modifying the content of their diet to meet DASH guidelines. Participants are explicitly asked not to exercise or to attempt weight loss at this time, and to focus their attention on what they eat. Following the 2-week feeding period, participants will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 5 participants).
16310050|NCT00571844|Behavioral|DASH diet plus Weight loss|Participants in the DASH diet plus weight loss condition will receive the DASH dietary intervention as described in the DASH diet intervention and will participate in a program to promote weight loss consisting of 2 components: Supervised Aerobic Exercise and CBWL (Cognitive Behavioral Weight loss). During supervised exercise participants will exercise 3x/week under medical supervision at the Duke Center for Living. A trained exercise physiologist will supervise all exercise sessions, and will obtain exercise BP measurements to make sure that BP is not abnormally elevated. For the CBWL participants will meet in small groups of 3-5 patients for instruction in weight management techniques. CBWL will include Appetite Awareness Training (AAT), a self-monitoring strategy developed to provide more specific guidelines regarding how much to eat. Individuals learn to identify moderate hunger and fullness and use these internal cues to guide their eating.
16310051|NCT00571831|Procedure|intraocular lens implantation|Intraocular lens implantation
16310052|NCT00571818|Procedure|Oral glucose tolerance test|test done over 2 hours
16310053|NCT00571818|Procedure|IV Glucose Tolerance Test|Done over 4 hours
16310054|NCT00571805|Drug|varencline|2.0 mg/day varencline (1.0 mg BID)
16310055|NCT00571805|Drug|placebo|matching placebo
16310056|NCT00571779|Device|AtriCure Bipolar System|
16310057|NCT00571766|Drug|L-Arginine|Oral L-Arginine 2g, twice a day for 14 weeks
16310058|NCT00571766|Drug|Placebo|Placebo 2 g twice a day for 14 weeks
16310059|NCT00571753|Drug|isoniazid|modified daily isoniazid dose according to NAT2 genotype (appr. 2.5 mg/kg, 5 mg/kg and 7.5 mg/kg for slow, intermediate and rapid acetylators, respectively).
16310060|NCT00571753|Drug|isoniazid|Treatment with a standard isoniazid dose of isoniazid (appr. 5 mg/kg b.w.)
16310061|NCT00571740|Biological|bevacizumab|Given IV
16310062|NCT00571740|Biological|cetuximab|Given IV
16310063|NCT00571740|Drug|fluorouracil|Given IV
16310064|NCT00571740|Drug|leucovorin calcium|Given IV
16310065|NCT00571740|Drug|oxaliplatin|Given IV
16310066|NCT00571727|Drug|mecasermin|injections BID of rhIGF-1, mecasermin
16310067|NCT00571714|Drug|Peginterferon alpha-2a and ribavirin|Peginterferon alpha-2a 180mcg by subcutaneous injection every week and weight based ribavirin, 800 to 1400mg/day by mouth in two divided doses every day for 48 weeks
16310068|NCT00571714|Drug|Peginterferon alpha-2a , ribavirin and betaine|Peginterferon alpha-2a 180mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400 mg/day by mouth in divided doses twice a day plus betaine 10 gm dissolved in juice twice a day for twelve weeks followed by peginterferon alpha-2a 180 mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400mg/day by mouth in divided doses twice a day for 36 weeks.
16310069|NCT00571701|Drug|celebrex (celecoxib)|Adults: 400 mg celebrex (celecoxib) daily Pediatrics: 100 mg celebrex (celecoxib) daily for weight between 12-25 kg or 200 mg Celebrex (celecoxib) daily for weight >25 kg
16310070|NCT00571701|Drug|placebo|similar appearing capsules containing inert ingredients
16310071|NCT00571688|Drug|Risperdal (risperidone) Consta|Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.
16310072|NCT00571688|Drug|Treatment as usual|Treatment was provided in this arm based solely on the choice of the treatment provider and participant. Treatment providers were not part of the study staff and were completely free to make treatment choices except that they were not allowed to select a long-acting injectible.
16310073|NCT00571675|Drug|AT-101, prednisone and docetaxel|docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
16310074|NCT00571675|Drug|placebo, prednisone and docetaxel|docetaxel (75mg/m2 intravenously over 1 hour every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3
16310075|NCT00571662|Drug|Pentostatin|4 mg/m^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8)
16310218|NCT00570674|Radiation|Intensity Modulated Radiation Therapy|
16310076|NCT00571662|Radiation|Total-body irradiation (TBI)|TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.
16310077|NCT00571662|Drug|Cyclosporine A (CsA)|CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD
16310078|NCT00571662|Drug|Mycophenolate Mofetil (MMF)|MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg.
16310079|NCT00571662|Drug|G-CSF|10 mcg/kg/day subcutaneously for at least 4 consecutive days.
16310080|NCT00571649|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
16310081|NCT00571649|Drug|Enoxaparin|Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
16310082|NCT00571649|Drug|Rivaroxaban placebo|Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days
16310083|NCT00571649|Drug|Enoxaparin placebo|Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
16310084|NCT00571636|Drug|Fentanyl|"The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.
~Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is > 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage."
16310085|NCT00571636|Drug|5% glucose solution|ev continuous infusion
16310086|NCT00571623|Other|Chest Physiotherapy|10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU
16310087|NCT00571610|Device|PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant|Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
16310088|NCT00571584|Drug|activated recombinant human factor VII|
16310089|NCT00571571|Behavioral|Psychotherapy|Individual psychotherapy with parent collateral/psychoeducation as necessary.
16310090|NCT00571571|Behavioral|Individual Psychotherapy|Individual psychotherapy and family interventions (as needed)
16310091|NCT00571558|Drug|aminolevulinic acid hydrochloride|Given PO
16310092|NCT00571558|Drug|photodynamic therapy|Undergo photodynamic therapy
16310093|NCT00571558|Other|laboratory biomarker analysis|Correlative studies
16310094|NCT00571545|Behavioral|Aerobic exercise|A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.
16310095|NCT00571545|Behavioral|No exercise|Controls were wait-listed for the exercise program during the 10 week study period.
16310096|NCT00571519|Drug|Rivoglitazone HCl|0.5 mg tablets administered orally, once daily
16310097|NCT00571519|Drug|rivoglitazone HCl|1.0 mg tablets administered orally, once daily
16310098|NCT00571519|Drug|rivoglitazone HCl|1.5 mg tablets administered orally, once daily
16310099|NCT00571519|Drug|placebo|placebo tablets matching rivoglitazone tablets administered orally, once daily
16310100|NCT00571519|Drug|pioglitazone HCl|15 mg capsules administered orally, once daily
16310101|NCT00571519|Drug|pioglitazone HCl|30 mg capsules administered orally, once daily
16310102|NCT00571519|Drug|pioglitazone HCl 45 mg|45 mg capsules administered orally, once daily
16310103|NCT00571519|Drug|placebo|placebo capsules for pioglitazone administered orally, once daily
16310104|NCT00571519|Drug|metformin|Oral tablets. Rescue medication.
16310105|NCT00571506|Drug|Rosiglitazone|Rosiglitazone 4 mg tablets by mouth daily for 3 months
16310106|NCT00571506|Drug|Pioglitazone|Pioglitazone 30 mg tablet by mouth once daily
16310107|NCT00571493|Drug|Bortezomib|Patients will receive bortezomib in four dose cohorts ( .8. 1.0, 1.3, 1.5 mg/m²). Patients will receive bortezomib on days -11, -8, -5, and -2 before infusion of autologous stem cells.
16310108|NCT00571493|Drug|BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)|"All study patients will receive BEAM per the standard institution protocol:
~BCNU (carmustine): 300 mg/m²on day -5 etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2 cytarabine 100 mg/m² twice daily on days -5, -4, -3, -2 melphalan: 140 mg/m² on day -1 before infusion of autologous stem cells."
16310109|NCT00571480|Other|acupuncture|ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
16310110|NCT00571480|Other|Sham acupuncture|ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
16310111|NCT00571480|Other|standard of care|participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
16310112|NCT00571467|Drug|PRTX-100 (Staphylococcal protein A)|"4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:
~Cohort 1: 0.075 mcg/kg
~Cohort 2: 0.15 mcg/kg
~Cohort 3: 0.30 mcg/kg"
16310113|NCT00571454|Behavioral|telephone depression care management|"1 call per week for first 4 weeks
~1 call every other week for next 8 weeks"
16310114|NCT00571428|Drug|Arformoterol Tartrate Inhalation Solution|Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)
16310115|NCT00571428|Drug|Arformoterol Tartrate Inhalation Solution|Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)
16310116|NCT00571428|Drug|Placebo|Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day
16310117|NCT00571402|Behavioral|Family-focused therapy for adolescents|FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
16310119|NCT00571376|Other|Health information technology and exchange|Health information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use of central repositories of data and peer-to-peer models.
16310120|NCT00571363|Procedure|standard surgery|excision with 4 mm margins
16310121|NCT00571363|Procedure|Mohs micrographic surgery|excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.
16310122|NCT00571350|Procedure|tvt-o operation|transvaginal tention free obturator tape
16310123|NCT00571350|Procedure|tvt o operation|transobturator vaginal tape insertion
16310124|NCT00571337|Drug|Infliximab|Stopping infliximab in patients having been treated with this drug for at least one year and in stable remission for at least 6 month.
16310125|NCT00571324|Drug|Exendin-(9-39)|A short term intravenous infusion of the study drug, exendin-(9-39), will be given over 6 hours.
16310126|NCT00571324|Other|Vehicle|A short term intravenous infusion of normal saline, or the vehicle, will be given over 6 hours.
16310127|NCT00571298|Procedure|Extrapleural pneumonectomy (EPP)|Resection of the lung, the lining of the lung (pleura), the covering of the heart (pericardium), and the muscle that separates the chest and abdomen (diaphragm)
16310128|NCT00571298|Drug|Cisplatin|Given after the tumor is removed as a bath (perfusion) for one-hour
16310129|NCT00571298|Drug|gemcitabine|Given after the tumor is removed as a bath (perfusion) for one-hour
16310130|NCT00571298|Drug|amifostine|Given intravenously before perfusion chemotherapy and then 2 hours after the first dose
16310131|NCT00571298|Drug|sodium thiosulfate|Given intravenously immediately at the end of perfusion chemotherapy
16310132|NCT00571298|Procedure|Pleurectomy/Decortication|Resection of the lining of the lung (pleura), while the lung remains intact.
16310133|NCT00571285|Dietary Supplement|Vitamin D3|600 IU Vitamin D3 capsule daily
16310134|NCT00571285|Dietary Supplement|Vitamin D3 - high dose|50,000 IU Vitamin D3 capsule once a week
16310135|NCT00571285|Dietary Supplement|Placebo|Placebo capsule given once a week
16310136|NCT00571259|Drug|Heparin 1000U/mL|A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
16310137|NCT00571259|Drug|4% Sodium Citrate with Gentamicin 320 mcg/mL|A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
16310138|NCT00571246|Drug|Topiramate|Participants are randomized to take Topiramate (250mg/day) 2 times a day
16310139|NCT00571246|Drug|lamotrigine|Participants are randomized to take Lamotrigine (250 mg/day) 2 times a day
16310140|NCT00571246|Other|Placebo|Participants are randomized to take placebo
16310141|NCT00571220|Procedure|gastric bypass surgery|weight loss bariatric surgery
16310142|NCT00571220|Other|Diet induced weight loss|low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
16310143|NCT00571207|Device|On-site oral fluid screening devices|Comparison of screening device results to oral and/or blood sample results
16310144|NCT00571207|Behavioral|Checklist: drug recognition expert|Correlation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases
16310145|NCT00571194|Drug|pravastatin|"A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours.
~Vital Signs and Physical Exams will also be done throughout the study"
16310146|NCT00571181|Device|Closed-loop system|Automatic delivery of propofol and remifentanil
16310147|NCT00571181|Device|TCI (Infusion Toolbox)|TCI administration of propofol and remifentanil
16310148|NCT00571168|Drug|Emend|125 mg/d on day 1; 80 mg/d on day 2-4
16310149|NCT00571168|Drug|Placebo|Placebo capsules on day 1-4
16310150|NCT00571155|Drug|levetiracetam|oral and intravenous dosing 2000-3000 mg per day
16310151|NCT00571142|Procedure|Bevacizumab + Pars plana vitrectomy|2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
16310152|NCT00571142|Procedure|Bevacizumab + pars plana vitrectomy|2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy
16310153|NCT00571129|Procedure|DCR with no tubes or mitomycin|"The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR.
~In revision group patients were randomized into the two groups,ether with or without application of mitomycin C after DCR"
16310154|NCT00571116|Drug|Disulfiram|Given PO
16310155|NCT00571116|Drug|Arsenic trioxide|Given IV
16310156|NCT00571103|Drug|acamprosate|Two 333mg tablets taken three times daily.
16310157|NCT00571090|Procedure|Thyroid ultrasonography|Ultrasound-guided thyroid fine-needle aspiration biopsy
16310158|NCT00571077|Device|Electrical Impedance Scanning (EIS) of the Thyroid gland|Patients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort.
16310159|NCT00571064|Drug|Donepezil HCl|One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.
16310160|NCT00571051|Behavioral|Mindfulness Based Stress Reduction|8 week course in mindfulness training
16310161|NCT00571038|Behavioral|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
16310162|NCT00571038|Behavioral|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
16310163|NCT00571025|Behavioral|APOE Disclosure|Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
16310164|NCT00570999|Drug|Palifermin|60 mg/kg/day
16310165|NCT00570999|Other|Placebo|1,2 mL once daily
16310166|NCT00570986|Drug|Placebo|Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
16310167|NCT00570986|Biological|ABT-874|200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
16310168|NCT00570986|Biological|ABT-874|100mg every 12 weeks.
16310169|NCT00570973|Procedure|endoscopic band ligation|Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
16310170|NCT00570973|Procedure|TIPS-Implantation|Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,
16310171|NCT00570960|Drug|Dextran 70|dextran 70, 1.0 g/kg on days one, two and three
16310172|NCT00570960|Biological|human albumin|human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
16310173|NCT00570947|Other|CPR Anytime Kit|The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program
16310174|NCT00570934|Dietary Supplement|Cholecalciferol|2000IU Cholecalciferol P.O. Q.D.
16310175|NCT00570934|Dietary Supplement|Calcium|1 gm calcium as calcium carbonate
16310176|NCT00570934|Dietary Supplement|Calcium and cholecalciferol|2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
16310177|NCT00570934|Drug|Placebo|Placebo
16310178|NCT00570921|Drug|Everolimus|Everolimus tablets, two-5 mg tablets a day
16310179|NCT00570921|Drug|Fulvestrant|intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter
16310180|NCT00570908|Drug|sunitinib|Sutent
16310181|NCT00570908|Drug|capecitabine|concurrently
16310182|NCT00570908|Radiation|WBRT|Whole Brain Radiotherapy 30 Gy in 10 fractions
16310183|NCT00570895|Dietary Supplement|Vitamin C|"Visit 1: Subjects will receive 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid.
~Visit 2: Subjects will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid.
~Visit 3: During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2."
16310184|NCT00570882|Drug|Sunitinib 2/1|Sunitinib 50 mg PO 2 weeks followed by 1 week rest
16310185|NCT00570882|Drug|Sunitinib 4/2|Sunitinib 50 mg PO 4 weeks followed by 2 week rest
16310186|NCT00570869|Other|CPR Anytime|These participants will be consented, surveyed, asked to watch a 22-minute instructional Infant CPR DVD with an infant manikin.
16310187|NCT00570856|Drug|Folic acid|Folic acid 5 mg/day
16310188|NCT00570856|Drug|Placebo|Placebo similar to the folic acid tablets, 1/day
16310189|NCT00570843|Drug|New PEG based artificial tear|1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
16310190|NCT00570843|Drug|Optive|1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)
16310191|NCT00570830|Device|Retisert (fluocinolone acetonide implant)|Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.
16310192|NCT00570817|Other|12 hours of prehydration|12 hours of prehydration with an infusion rate of 150 ml/m2/hour with a solution of 5% glucose with 40 mmol sodium bicarbonate/L and 20 mmol potassium chloride/L.
16310193|NCT00570804|Behavioral|Telephone Counseling|7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.
16310194|NCT00570804|Behavioral|Telephone Assessments|4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.
16310195|NCT00570791|Device|Tonometer|Tonometer devices used to measure IOP: Pascal Dynamic Contour Tonometer, Goldman Applanation Tonometer, Tono Pen, Reichart pneumatonometer, Langham Ocular Blood Flow, Schiotz Tonometer and ICare tonometer
16310196|NCT00570778|Drug|indacaterol/glycopyrrolate|Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
16310197|NCT00570778|Drug|indacaterol|Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
16310198|NCT00570778|Drug|placebo|Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
16310199|NCT00570765|Drug|Placebo|Matching placebo tablets were administered orally once daily.
16310200|NCT00570765|Drug|Obeticholic Acid (OCA)|Starting dose of 10 or 50 mg administered orally once daily, followed by dose titration planned from 10 mg to 25 mg to 50 mg once daily, which could be modified for safety and tolerability issues or to achieve adequate therapeutic response.
16310201|NCT00570752|Other|Placebo|
16310202|NCT00570752|Drug|BMS-582949|
16310203|NCT00570752|Drug|Atorvastatin|
16310204|NCT00570752|Drug|Statin|
16310205|NCT00570739|Drug|Metformin HCl and Colesevelam Placebo|One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
16310206|NCT00570739|Drug|Metformin HCl tablets and Colesevelam tablets|One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
16310207|NCT00570739|Drug|Colesevelam placebo|Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
16310208|NCT00570739|Drug|Colesevelam|Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
16310209|NCT00570726|Drug|Ranibizumab (Lucentis)|
16310210|NCT00570713|Drug|MORAb-009|Monoclonal antibody administered once weekly by intravenous injection.
16310211|NCT00570713|Drug|Placebo|As per package insert.
16310212|NCT00570713|Drug|Gemcitabine|Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
16310213|NCT00570700|Drug|Dasatinib|150mg (3 pills) orally daily for as long as the drug benefits
16310214|NCT00570687|Drug|Technosphere Insulin|Inhalation 15U/30U
16310215|NCT00570674|Drug|Abraxane|
16310216|NCT00570674|Drug|Erbitux|
16310217|NCT00570674|Drug|Carboplatin|
16310219|NCT00570661|Drug|ITF2357|ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.
16310220|NCT00570648|Drug|sodium hyaluronate|1% sodium hyaluronate applied at the end of corneal transplant surgery. The amount will be determined on how much is necessary to cover the ocular surface.
16310221|NCT00570635|Drug|XL820|XL820 capsules administered orally as a single agent at a dose of 800 mg daily
16310222|NCT00570635|Drug|XL820|XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
16310223|NCT00570622|Drug|Pioglitazone|Patients receive 60mg of pioglitazone once a day orally for 9 days
16310224|NCT00570622|Drug|Placebo|Patients receive placebo once a day orally for 9 days
16310225|NCT00570609|Other|CPR Anytime education|After consent, participants will be asked to complete the 22 minute DVD CPR Anytime program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program
16310226|NCT00570570|Procedure|Muscular Strengthening for paretic knee flexor and extensor|thrice a week during 6 weeks
16310227|NCT00570570|Other|conventional physiotherapy|trice a week during 6 weeks
16310228|NCT00570557|Other|TOR-BSST© Refresher Training|Web-based refresher training in dysphagia screening
16310229|NCT00570544|Drug|tiotropium|18ug capsule daily for 30 days
16310230|NCT00570531|Drug|Bevacizumab|Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
16310231|NCT00570531|Drug|Paclitaxel|Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration.
16310232|NCT00570531|Drug|Cisplatin|Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel.
16310233|NCT00570531|Drug|5-Fluorouracil|Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
16310234|NCT00570531|Radiation|Radiation Therapy|Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered.
16310235|NCT00570531|Procedure|Esophagectomy|Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)
16310236|NCT00570505|Device|LAP-BAND System|Reduction of food intake due to creation of smaller stomach pouch
16310237|NCT00570492|Drug|Fluticasone furoate nasal spray|Fluticasone furoate nasal spray 110mg QD
16310238|NCT00570492|Drug|Placebo nasal spray|Placebo nasal spray
16310239|NCT00570479|Drug|anecortave acetate|Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
16310240|NCT00570466|Behavioral|Video Games|Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.
16310241|NCT00570466|Behavioral|Web and DVD knowledge|Web and DVD based knowledge games
16310242|NCT00570440|Drug|Oral contraceptives--ethinyl estradiol, levonorgestrel|3 visits - screening/enrollment, 6-months and 12 months
16310243|NCT00570427|Behavioral|Problem Solving Therapy (PST)|Counseling
16310244|NCT00570427|Behavioral|Medication Management|If a participant chooses to receive antidepressant medication while in the study, a depression care specialist works with the participant's usual primary care provider to initiate an appropriate prescription and to follow-up with side effects, adherence, efficacy, etc. on a monthly or biweekly basis.
16310245|NCT00570414|Device|Laryngeal mask airway|Airway management by the use of the flexible, reinforced laryngeal mask airway
16310246|NCT00570414|Device|Endotracheal tube|Airway management by the use of endotracheal tube
16310247|NCT00570401|Drug|dasatinib|
16310248|NCT00570388|Drug|Prometa Treatment Program|"Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion.
~Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep.
~Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
~Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
~Days 4 through 28•Gabapentin 1200 mg po 9 PM
~Days 29 through 31•Gabapentin 900 mg po 9 PM
~Days 32 through 34•Gabapentin 600 mg po 9 PM
~Days 35 through 38•Gabapentin 300 mg po 9 PM
~Flumazenil Dosing Schedule
~2 mg flumazenil is given as a slow IV push. Subjects in the placebo group will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol."
16310249|NCT00570375|Drug|Erlotinib|150 mg, PO, QD beginning day 1 week 1. Patients will receive treatment for 16 weeks as long as there is no evidence of disease progression. In no response is noted after 16 weeks of treatment, patients will be taken off the study. Patients achieving response (HI, CR, or PR) will continue on treatment until evidence of disease progression or relapse.
16310250|NCT00570349|Drug|Nitric Oxide for Inhalation|Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period.
16310251|NCT00570349|Drug|Nitric Oxide for Inhalation|Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period.
16310252|NCT00570349|Drug|Nitrogen|100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.
16310253|NCT00570336|Drug|CTS-1027|Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
16310254|NCT00570336|Other|Placebo|Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.
16310255|NCT00570323|Drug|Arimidex|Aromatase inhibitors
16310256|NCT00570323|Drug|Faslodex|Hormone Receptor
16310257|NCT00570310|Drug|Comparator: pregabalin|pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
16310258|NCT00570310|Drug|Comparator: Placebo (unspecified)|pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
16310259|NCT00570284|Drug|LBH589|orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)
16310260|NCT00570271|Other|Placebo with BP dec (written form)|Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
16310261|NCT00570271|Other|Placebo with BP dec (doctor)|Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
16310262|NCT00570271|Other|Placebo with BP inc (written)|Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
16310263|NCT00570271|Other|Placebo with BP inc (doctor)|Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
16310264|NCT00570271|Other|Placebo info given (written)|Subject informed about receiving placebo. Information provided to subjects in written form.
16310265|NCT00570271|Other|Placebo info given (doc)|Subject informed about receiving placebo. Information provided to subjects by doctor.
16310266|NCT00570258|Drug|Fulvestrant|Fulvestrant: 250 mg IM Q 4 weeks
16310267|NCT00570258|Drug|erlotinib|150 mg PO QD
16310268|NCT00570258|Drug|Fulvestrant|250 mg IM Q 4 weeks
16310269|NCT00570258|Drug|Placebo|Placebo 150 mg PO QD
16310270|NCT00570245|Drug|Nitric oxide|inhalation, 10 ppm, for up to 48 hours
16310271|NCT00570245|Drug|Nitric oxide|inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)
16310272|NCT00570232|Drug|Erlotinib|150 mg per day by mouth for 12 months
16310273|NCT00570219|Drug|valproate|Valproate 20 mg/kg per day for 2 weeks, reduction during week 3. Conversion of benzodiazepines to an equivalent dose of diazepam (maximum 80 mg per day). Dosage reduced 10 mg daily until 40 mg per day. Reduction then continued 5 mg daily.
16310274|NCT00570206|Behavioral|Motivational Interviewing|Probation officers trained to use Motivational Interviewing while conducting meetings with probationers.
16310275|NCT00570193|Drug|verteporfin (Visudyne)|Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
16310276|NCT00570193|Drug|ranibizumab (Lucentis)|ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
16310277|NCT00570180|Drug|Bortezomib|21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.
16310278|NCT00570167|Procedure|Hip resurfacacing|Hip resurfacing with cementless acetabular cup and cemented femoral head
16310279|NCT00570167|Procedure|Cementless total hip arthroplasty with m-o-m bearings|Cementless monoblock acetabular cup and cementless femoral stem with modular large head and metal-on-metal bearings..
16310280|NCT00570141|Device|OASIS Wound Matrix|OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
16310281|NCT00570128|Drug|Donepezil HCl|Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for participants with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).
16310282|NCT00570128|Drug|Placebo|Liquid formulation matched to active treatment for oral administration.
16310283|NCT00570102|Dietary Supplement|A highly hydrolyzed formula|Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months
16310284|NCT00570102|Dietary Supplement|A regular cow's milk based formula|Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin
16310285|NCT00570089|Drug|Ranolazine|500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
16310286|NCT00570089|Drug|Placebo|Placebo, 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
16310287|NCT00570063|Drug|PF-02545920|Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
16310288|NCT00570063|Drug|Placebo|Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
16310289|NCT00570050|Drug|Diluent / Insulin|Diluent (4 Weeks ) / Intranasal insulin (4 weeks)
16310290|NCT00570050|Drug|Insulin / Diluent|Intranasal Insulin (4 Weeks ) / Diluent (4 Weeks)
16310291|NCT00570037|Biological|Trivalent inactivated influenza vaccine|Intramuscular injection, 0.5 mL or 0.25 mL depending on age of vaccine recipient, one or two doses administered a month apart depending on age and prior influenza vaccination history of recipient
16310292|NCT00570024|Procedure|Traditional Acupuncture|In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
16310293|NCT00570024|Procedure|AA|In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
16310294|NCT00570011|Drug|Somatropin|3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.
16310295|NCT00570011|Drug|Somatropin|6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.
16310296|NCT00569998|Device|NovoPen™ 4|
16310297|NCT00569998|Device|NovoPen® 3|
16310298|NCT00569985|Biological|lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells|Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
16310299|NCT00569985|Drug|carmustine|Given IV
16310300|NCT00569985|Drug|cyclophosphamide|Given IV
16310301|NCT00569985|Drug|etoposide|Given IV
16310302|NCT00569985|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
16310303|NCT00569972|Drug|PD 0200390|Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
16310304|NCT00569972|Drug|PD 0200390|Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
16310305|NCT00569972|Drug|PD 0200390|Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
16310306|NCT00569972|Drug|PD 0200390|Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
16310307|NCT00569972|Drug|Placebo|Matched oral placebo for weeks 2-7.
16310308|NCT00569959|Other|fasting 12+ hours|fasting 12+ hours
16310309|NCT00569959|Other|Non-fasting|Non-fasting
16310310|NCT00569946|Drug|AG-013736|"AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.
~Number of cycles: until progression or unacceptable toxicity develops."
16310311|NCT00569933|Behavioral|Audio recording|Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.
16310312|NCT00569920|Drug|dexamethasone|IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).
16310313|NCT00569920|Drug|natriumchloride 0,9%|iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
16310314|NCT00569920|Drug|dexamethasone|IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
16310315|NCT00569894|Biological|FLuMist|One or two vaccinations with FluMist depending on prior vaccination status.
16310316|NCT00569894|Biological|TIV (Injection)|One or two injections of TIV depending on previous status.
16310317|NCT00569894|Other|Unvaccinated Control|no vaccine
16310318|NCT00569881|Drug|gatifloxacin and moxifloxacin|Comparison of wound healing between drugs
16310319|NCT00569868|Drug|Velcade|"Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.
~The platelet Aggregation Test will be done only if Platelet count is 100 000."
16310320|NCT00569855|Drug|Phenoxybenzamine|0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU
16310321|NCT00569829|Behavioral|cognitive behavioral therapy|1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
16310322|NCT00569816|Drug|Sevoflurane|1 MAC Sevoflurane will be given either continuously after induction of anesthesia until initiation of cardiopulmonary bypass or will be repetitively washed in and out twice before initiation of cardiopulmonary bypass.
16310323|NCT00569803|Drug|belatacept|single dose, 116 days
16310324|NCT00569803|Drug|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
16310325|NCT00569790|Drug|S-1, Irinotecan, Bevacizumab|"S-1 is administered orally on days 1 to 14 of a 28-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Irinotecan 100 mg/m2 is administered by intravenous infusion on days 1 and 15. Bevacizumab 5 mg/kg (body weight)is administered by intravenous infusion on days 1 and 15."
16310326|NCT00569777|Device|K-Lens (generic name not established) and Ketotifen|combination drug-device product: contact lens (device) and anti-allergy drug
16310327|NCT00569777|Device|Placebo Lens|contact lens without drug
16310328|NCT00569751|Device|TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System|Drug Eluting Stent used to treat de novo coronary artery lesions.
16310329|NCT00569738|Procedure|PET scan with Ga68-DOTANOC|Imaging: PET scan with Ga68-DOTANOC
16310330|NCT00569712|Drug|budesonide/formoterol fumarate dihydrate inhalation aerosol|
16310331|NCT00569712|Genetic|DNA methylation analysis|
16310332|NCT00569712|Genetic|comparative genomic hybridization|
16310333|NCT00569712|Genetic|microarray analysis|
16310334|NCT00569712|Other|bronchoalveolar lavage|
16310335|NCT00569712|Other|immunoenzyme technique|
16310336|NCT00569712|Other|laboratory biomarker analysis|
16310337|NCT00569712|Procedure|bronchoscopy|
16310338|NCT00569699|Drug|S-1, Bevacizumab|"S-1 is administered orally on days 1 to 28 of a 42-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25 m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15."
16310339|NCT00569686|Drug|lovaza|lovaza 4 gm po daily
16310340|NCT00569686|Drug|placebo|placebo
16310341|NCT00569673|Biological|filgrastim|
16310342|NCT00569673|Biological|pegfilgrastim|
16310343|NCT00569673|Drug|docetaxel|
16310344|NCT00569673|Drug|trabectedin|
16310345|NCT00569660|Drug|Azacitidine|75 mg/m^2 subcutaneous daily for 7 days (every 4 week cycle)
16310346|NCT00569647|Device|Virtual Reality Hypnosis|Use of virtual reality headset to induce hypnotic state
16310347|NCT00569647|Device|Placebo|no use of device
16310348|NCT00569634|Procedure|Venous blood gas analysis|When an ABG is deemed to be necessary as part of ICU management, a central venous sample will also be obtained with minimum delay (always < 2 minutes) between the samples. The samples will be analyzed by a blood gas analyzer as quickly as possible.
16310349|NCT00569621|Drug|Moxaverine|intravenous administration
16310350|NCT00569621|Drug|physiological saline|intravenous administration
16310351|NCT00569608|Other|Early Discharge|Application of an early discharge protocol from the neonatal intensive care unit.
16310352|NCT00569595|Behavioral|Self-Care Stimulating Disease Prevention Program|The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
16310353|NCT00569595|Behavioral|Fighting Cancer with Advice|"Patient health counseling program by lay health educators entitled Fighting Cancer with Advice."
16310354|NCT00569582|Drug|mifepristone|Patients take mifepristone by mouth once a day. The dose is increased during scheduled timepoints during the study or until symptoms improve or the highest dosage allowed is reached. Dose escalation will be based upon weight. During clinic visits, blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis will be performed.
16310355|NCT00569569|Drug|juxtascleral depot injection of Retaane|juxtascleral depot injection of Retaane
16310356|NCT00569556|Other|Case Management|Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed
16310357|NCT00569543|Other|high performance liquid chromatography|urine analysis
16310358|NCT00569543|Other|laboratory biomarker analysis|The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
16310359|NCT00569543|Other|mass spectrometry|The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.
16310360|NCT00569543|Other|medical chart review|Collection of information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease.
16310361|NCT00569530|Drug|Infasurf (ONY Inc.)|Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
16310362|NCT00569530|Drug|Sham|Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
16310363|NCT00569517|Behavioral|CBT|6-CBT based sesions
16310364|NCT00569517|Other|educational|subjects receive one hour of nutrition education and 5 weekly phone calls
16310365|NCT00569491|Device|TAXUS Express 2™|TAXUS Express™ Paclitaxel-Eluting Coronary Stent System
16310366|NCT00569478|Other|rehabilitation|Nursing consultations and physical training
16310367|NCT00569465|Drug|Arginine|1200 mg, once a day
16310368|NCT00569465|Drug|Acetylcysteine|600 mg twice a day
16310369|NCT00569465|Drug|Placebo|3 vials a day
16310370|NCT00569452|Device|Accu-Chek Spirit Insulin Pump|One basal rate
16310371|NCT00569452|Device|Accu-Chek Spirit Insulin Pump|Multiple basal rates
16310372|NCT00569439|Drug|D5NS|5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
16310373|NCT00569439|Drug|D10NS|10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
16310374|NCT00569439|Drug|NS|Normal Saline solution at 125 cc/hr
16310375|NCT00569426|Device|NovoFine® needle 6 mm|
16310376|NCT00569426|Device|NovoFine® needle 8 mm|
16310377|NCT00569400|Drug|human insulin|
16310378|NCT00569387|Biological|HyperAcute(R)-Pancreatic Cancer Vaccine|100 million vaccine cells will be injected intradermally for up to 14 vaccinations over approximately 8 months
16310379|NCT00569374|Drug|Modafinil|subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
16310380|NCT00569361|Procedure|Collection of nasal epithelial cells|Collection of nasal epithelial cells by brushing
16310381|NCT00569335|Drug|S-1, Irinotecan, Bevacizumab|"S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
~Irinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1."
16310382|NCT00569322|Procedure|BG Test|
16310383|NCT00569309|Biological|Streptococcus pneumoniae|Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
16310384|NCT00569309|Other|laboratory correlative studies|Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
16310385|NCT00569309|Other|quality-of-life assessment|Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.
16310386|NCT00569296|Biological|EGFRBi-armed autologous activated T cells|Dose escalation, dosage depends on when entered in study. 8 infusions (twice a week over 4 weeks. Each infusion will be over at least 1 hour.
16310387|NCT00569296|Biological|aldesleukin|300,00IU/m2/day beginning 3 days before the first Activated T-cell infusion and ending 1 week after the last infusion
16310388|NCT00569296|Biological|sargramostim|250 micrograms/m2/twice weekly beginning 3 days before the first activated T-cell infusion and ending 1 week after the last Activated T-cell infusion
16310389|NCT00569283|Biological|therapeutic allogeneic lymphocytes|
16310390|NCT00569270|Drug|Placebo|Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
16310391|NCT00569257|Drug|AEZS-108|intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
16310392|NCT00569244|Drug|Drug: YAZ flex (SH T00186D)|Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
16310393|NCT00569244|Drug|YAZ (SH T00186D)|YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
16310394|NCT00569231|Drug|Candida Antigen|Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
16310395|NCT00569192|Drug|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
16310396|NCT00569192|Drug|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
16310397|NCT00569192|Drug|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
16310398|NCT00569179|Device|CliniMACS CD34 Reagent System|Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
16310399|NCT00569166|Behavioral|Paced breathing (15 min once daily, 6 breaths/min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
16310400|NCT00569166|Behavioral|Paced breathing (15 min twice daily, 6 breaths/min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
16310401|NCT00569166|Behavioral|Paced breathing (10 min once daily, 14 breaths/min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
16310402|NCT00569153|Drug|TAK-700|"Phase 1 portion of study:
~TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.
~Phase 2 portion of study:
~Patients will receive one of 4 treatments:
~TAK-700 at 300 mg twice/day
~TAK-700 at 400 mg and 5 mg prednisone twice/day
~TAK-700 at 600 mg and 5 mg prednisone twice/day
~TAK-700 at 600 mg once/day in the morning"
16310403|NCT00569140|Drug|E10030|Intravitreal injection
16310404|NCT00569127|Biological|Bevacizumab|Given IV
16310405|NCT00569127|Other|Laboratory Biomarker Analysis|Correlative studies
16310406|NCT00569127|Drug|Octreotide Acetate|Given IM
16310407|NCT00569127|Biological|Recombinant Interferon Alfa-2b|Given SC
16310408|NCT00569114|Drug|TG01|Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD
16310409|NCT00569101|Drug|tacrolimus|during the first 2 months : tacrolimus 0.1 mg/kg + prednisolone 0.8 mg/kg p.o. ,then after : tacrolimus 0.1 mg ~0.02 mg/kg + prednisolone tapering
16310410|NCT00569088|Drug|Chinese herbs formula|"The chinese herbs formula includes eight herbs,and they are Radix et Rhizoma Rhei Palmati(Rhubarb,10 grams),Cornu Bubali(Buffalo Horn,30 grams),Radix Paeoniae Bubra(Red Peony Root,15 grams),Cortex Moutan Radicis(Tree Peony Root-bark,10 grams),Radix Rehmanniae(Adhesive Rehmannia Root Tuber,20 grams),Pheretima Aspergillum(Earth-worm,10 grams),Radix Notoginseng(Sanchi,5 grams)and Rhizoma Acori Tarainowii(Tararinow Sweetflag Rhizome,10 grams).
~Boiled together. 150ml of the juice,p.o.,twice a day,for 28 days"
16310411|NCT00569088|Drug|Mannitol|250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days
16310412|NCT00569075|Other|collection of gingival crevicular fluid|GCF samples will be collected at 3 month intervals
16310413|NCT00569062|Drug|GW856553X|GW856553X 7.5mg BID for 6 weeks
16310414|NCT00569062|Other|Placebo|Placebo to match GW856553X
16310415|NCT00569049|Procedure|breast tissue, lymph node tissue or blood|Molecular Analyses of samples
16310416|NCT00569036|Drug|BMS-754807|Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
16310417|NCT00569023|Dietary Supplement|alga Dunaliella bardawil|"Each patients will be treated with four capsules daily of Dunaliella bardawil for 90 days.
~Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers"
16310418|NCT00569010|Drug|Azacitidine|Group 1 and 3 at Level 0 = 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
16310419|NCT00569010|Drug|Ara-C|"Group 1 and 2 at Low-Dose = 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days
~Arms 3 and 4 at High-dose = 1 g/m^2 Daily CIV for 4 days (age<65 years) or 3 days (age>=65 years)"
16310420|NCT00568997|Drug|Pimecrolimus|Pimecrolimus 1% cream
16310421|NCT00568984|Drug|repaglinide|
16310422|NCT00568984|Drug|metformin|
16310423|NCT00568984|Drug|glicazide|
16310424|NCT00568971|Drug|Docetaxel, Cisplatin, 5-Fu|Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
16310425|NCT00568958|Behavioral|BASICS counseling|Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
16310426|NCT00568958|Drug|naltrexone|Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
16310427|NCT00568958|Drug|placebo naltrexone|Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
16310428|NCT00568945|Drug|Capadenoson (BAY68-4986)|4 mg BAY68-4986 for five days
16310429|NCT00568893|Drug|drotrecogin alfa (activated)|
16310430|NCT00568880|Drug|bortezomib|bortezomib 1.0-1.3mg/m2 IV
16310431|NCT00568880|Drug|hydroxychloroquine|hydroxychloroquine 200 mg pill
16310432|NCT00568854|Biological|BCG|Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
16310433|NCT00568841|Drug|erlotinib|erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
16310434|NCT00568841|Procedure|FDG-/FLT-PET|
16310435|NCT00568815|Drug|Rituximab combined with ESHAP|Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5
16310436|NCT00568802|Drug|Hydroxyurea|
16310437|NCT00568802|Drug|Placebo to match hydroxyurea|
16310438|NCT00568789|Drug|Ramelteon, zolpidem and placebo|"Ramelteon 8 mg, tablets, orally, one night only during Period 1, 2 or 3
~Zolpidem 10 mg, tablets, orally, one night only during Period 1, 2 or 3
~Ramelteon/Zolpidem placebo-matching tablets, orally one night only during Period 1, 2 or 3"
16310848|NCT00565968|Genetic|gene expression analysis|
16310439|NCT00568776|Drug|Placebo Control|ELND005 matched placebo capsules for oral administration, bid for 78 weeks
16310440|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
16310441|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
16310442|NCT00568776|Drug|ELND005|ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
16310443|NCT00568763|Biological|sargramostim|
16310444|NCT00568763|Other|immunoenzyme technique|
16310445|NCT00568763|Other|immunohistochemistry staining method|
16310446|NCT00568763|Other|immunologic technique|
16310447|NCT00568763|Other|laboratory biomarker analysis|
16310448|NCT00568763|Procedure|biopsy|
16310449|NCT00568763|Procedure|cryosurgery|
16310450|NCT00568763|Procedure|radiofrequency ablation|
16310451|NCT00568750|Drug|dasatinib|Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
16310452|NCT00568737|Drug|Drotrecogin alfa (activated)|Drotrecogin Alfa (activated)
16310453|NCT00568737|Drug|Placebo|0.9% sodium chloride
16310454|NCT00568711|Drug|doxycycline|a 5-day course of 100 mg bid doses of doxycycline
16310455|NCT00568711|Drug|rifampin|a 5-day course of daily 600-mg doses of rifampin
16310456|NCT00568698|Drug|Hydroxyurea|
16310457|NCT00568698|Drug|Placebo to match hydroxyurea|
16310458|NCT00568685|Drug|Atomoxetine Hydrochloride|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
16310459|NCT00568685|Drug|Atomoxetine hydrochloride|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
16310460|NCT00568685|Drug|Atomoxetine hydrochloride|"Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.
~Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days"
16310461|NCT00568672|Drug|Olanzapine|Olanzapine 5 mg / day for 6 months
16310462|NCT00568659|Procedure|specific elastance|The investigators study the specific lung elastance in ALI/ARDS patients in supine and prone position.
16310463|NCT00568646|Drug|MKC-1|Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles
16310464|NCT00568633|Procedure|Allogeneic HSCT|Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.
16310465|NCT00568633|Drug|Anti-thymocyte globulin (ATG)|1.5 mg/kg for 5 days by IV
16310466|NCT00568633|Drug|Cyclosporine (CSP)|6.25 mg/kg twice daily oral
16310467|NCT00568633|Drug|Mycophenolate mofetil (MMF)|15 mg/kg twice daily oral
16310468|NCT00568633|Radiation|Total lymphoid irradiation (TLI)|80 cGy/fraction radiotherapy in 10 fractions.
16310469|NCT00568633|Drug|Methylprednisolone sodium succinate|1.0 mg/kg for 5 days by IV
16310470|NCT00568633|Drug|Best standard care|"Intervention consist of:
~Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
~Autologous transplantation
~Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
~Umbilical cord blood transplantation
~Haploidentical transplantation"
16310471|NCT00568620|Procedure|Placement of nasogastric feeding tube|"Glucose tolerance test via nasogastric feeding tube
~50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3"
16310472|NCT00568620|Procedure|Nasojejunal feeding tube|"Glucose tolerance test via nasojejunal feeding tube
~50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3"
16310473|NCT00568607|Drug|IFO, VP-16, DDP, DXM|DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
16310474|NCT00568594|Drug|APL180|
16310475|NCT00568594|Drug|Placebo|
16310476|NCT00568568|Drug|Growth hormone|GH infusion from 8.00 pm to 03.00 am (dose 10,2 ng/kg/min) c) GH infusion from 02.00 am to 09.00 am (dose 10,2 ng/kg/min).
16310477|NCT00568555|Drug|Low Dose Naltrexone|3-4.5mg Naltrexone once daily
16310478|NCT00568555|Drug|Placebo - sugar pill|Placebo pill once daily
16310479|NCT00568542|Drug|erythropoetin beta|35 I.E. kg body weight subcutaneous once per week for 6 months
16310480|NCT00568542|Drug|placebo|35 I.E. kg body weight placebo to erythropoetin beta
16310481|NCT00568529|Drug|Capecitabine and Oxaliplatin|Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w
16310482|NCT00568516|Drug|ASP3550|subcutaneous administration
16310483|NCT00568503|Drug|QAX028|
16310484|NCT00568503|Drug|Placebo|
16310485|NCT00568503|Drug|Tiotropium bromide|
16310486|NCT00568503|Drug|QAX028|
16310487|NCT00568503|Drug|QAX028|
16310488|NCT00568490|Procedure|Tumor biopsy|For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen
16310489|NCT00568490|Procedure|Phlebotomy|Blood draw (approximately 20 cc) prior to any anticancer therapy Weekly blood draw (approximately 20cc) only for patients who are undergoing radiation treatment at Stanford University
16310490|NCT00568477|Drug|MabThera|"Rituximab (MabThera):
~375 mg/m² as IV infusions over >=6h each at time point 0 and 2 weeks. Initial infusion rate of 50 mg/h, stepwise rise is possible after 30 minutes"
16310491|NCT00568464|Drug|VCR, CTX, ADM; IFO, VP-16|VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
16310492|NCT00568451|Drug|carboplatin|AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
16310493|NCT00568451|Drug|paclitaxel|100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
16310494|NCT00568451|Drug|temozolomide|150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks
16310495|NCT00568412|Device|Zarzenda|Topical cream, applied twice daily for three weeks
16310496|NCT00568412|Drug|Elidel|1% cream, applied topically twice daily for three weeks
16310497|NCT00568399|Drug|sodium thiosulfate|sodium thiosulfate 12.5-25 gm/M2 after each thrice weekly hemodialysis treatments for 5 months.
16310498|NCT00568386|Other|Systane Lubricant Eye Drops|Systane Lubricant Eye Drops 1 drop each eye once time
16310499|NCT00568386|Other|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops 1 drop each eye one time
16310500|NCT00568373|Device|Enterra Gastric Pacemaker|Gastric Pacemaker
16310501|NCT00568360|Device|Oximeter|
16310502|NCT00568347|Drug|fluticasone 100mcg/ salmeterol 50mcg|inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
16310503|NCT00568347|Drug|fluticasone 250/salmeterol 50|inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
16310504|NCT00568347|Drug|salmeterol|salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
16310505|NCT00568347|Drug|Salmeterol|salmeterol 50mcg bid X 3months
16310506|NCT00568347|Drug|salmeterol and fluticasone propionate|salmeterol 50mcg/fluticasone 250mcg by DPI bid
16310507|NCT00568334|Biological|Varilrix (inactivated varicella vaccine)|subcutaneously injection
16310508|NCT00568321|Drug|RN624|50 mcg/kg
16310509|NCT00568321|Drug|RN624|200 mcg/kg
16310510|NCT00568321|Drug|Placebo|placebo
16310511|NCT00568308|Drug|PI-88|160mg subcutaneous injection
16310512|NCT00568308|Drug|placebo|matched placebo
16310513|NCT00568295|Drug|acetaminophen|Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
16310514|NCT00568295|Drug|Rofecoxib|Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
16310515|NCT00568295|Drug|Rofecoxib|Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
16310516|NCT00568282|Procedure|phlebotomy|Standard of care
16310517|NCT00568269|Procedure|Open repair|Open repair is according to the Lichtenstein technique
16310518|NCT00568269|Procedure|Laparoscopic repair|The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair
16310519|NCT00568256|Behavioral|Mind/Body Courses|8-week Mind/Body course held once a week for 2 hours at a time.
16310520|NCT00568230|Device|PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant|Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
16310521|NCT00568217|Drug|Diclofenac, Paracetamol, Ibuprofen|Immediately if temperature > 38 degree Celsius, diclofenac suppository 1,5 mg/kg once or placebo suppository After eight hours, if temperature still < 38 degree Celsius, acetaminophen mixture 15 mg/kg up to four times a day, or ibuprofen mixture 10 mg/kg up to four times a day, or placebo mixture up to four times a day as long as temperature < 38 degree Celsius
16310522|NCT00568204|Device|Mexyn-A|Atomised topical self-chilled pressurised spray
16310523|NCT00568178|Drug|Losartan Potassium|"Losartan Use During the Double-Blind Treatment Phase:
~Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg)
~or 100 mg/day (if the patient weighed ≥50 kg).
~Losartan Use During the Treatment Extension Phase:
~Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance."
16310524|NCT00568178|Other|Comparator: Placebo (Losartan)|Placebo (losartan suspension), administered orally, once daily for 12 weeks
16310525|NCT00568178|Drug|Comparator: amlodipine besylate|Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks
16310526|NCT00568178|Other|Comparator: Placebo (amlodipine besylate)|Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
16310527|NCT00568178|Other|Placebo (Losartan)|Normotensive patients randomized to losartan placebo for 12 weeks.
16310528|NCT00568178|Drug|Enalapril Maleate|Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
16310529|NCT00568165|Procedure|Mobile team|a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward
16310530|NCT00568165|Procedure|Standard care|Standard care
16310531|NCT00568152|Dietary Supplement|Low PA apple puree|Golden Delicious apple puree 230grams consumed daily for 14 days
16310532|NCT00568152|Dietary Supplement|High PA apple puree|High PA apple puree (Mitchalin) consumed daily for 14 days
16310533|NCT00568152|Drug|Aspirin|75mg dispersable aspirin taken daily for 14 days
16310534|NCT00568126|Drug|Maca Root|3g/day of Maca Root for 12 weeks.
16310535|NCT00568126|Drug|Placebo|Placebo provided by research pharmacy daily for 12 weeks.
16310593|NCT00567684|Other|Intravenous Urography (IVU)|A routine IVU procedure performed prior to or after CTU.
16310594|NCT00567671|Procedure|Corneal collagen|Corneal collagen cross-linking with riboflavin/UVA light
16310536|NCT00568113|Drug|acetylcysteine in arm 1|"Arm 2, control group: given hydroxyl progesterone caproate (150mgm) every 3 days starting from the 28th week of pregnancy till completed 36 weeks of gestation.
~Arm 1 patients were given hydroxyl progesterone caproate (150mgm) weekly injections plus NAC 0.6 gm (Sedico, Egypt) orally daily starting from the 28th week of pregnancy till delivery or completed 36th week of pregnancy."
16310537|NCT00568100|Procedure|PSV and NAVA|evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients
16310538|NCT00568087|Drug|N-acetylcysteine|Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.
16310539|NCT00568087|Drug|Placebo|Patients will take oral placebo (identical matching placebo) during the study period.
16310540|NCT00568074|Drug|repaglinide|
16310541|NCT00568074|Drug|Glurenorm®|
16310542|NCT00568074|Drug|Glucobay®|
16310543|NCT00568061|Drug|Nitric Oxide|Nitric oxide for inhalation
16310544|NCT00568061|Drug|Placebo|Nitrogen gas (placebo) for inhalation
16310545|NCT00568048|Biological|bevacizumab|10 mg/kg i.v., on day 1 of every cycle (14 days) until PD or any other event qualifying for stopping treatment
16310546|NCT00568048|Drug|temozolomide|150 mg/m2 p.o., on days 1-7 of every cycle (14 days) until PD or any other event qualifying for stopping treatment
16310547|NCT00568035|Drug|QR-333|QR-333 or placebo will be applied three times a day for 12 weeks
16310548|NCT00568022|Drug|Ixabepilone|Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles
16310549|NCT00568022|Drug|Capecitabine|Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles
16310550|NCT00568009|Drug|SLV320|1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
16310551|NCT00567996|Drug|Indacaterol 150 μg|Indacaterol 150 μg once daily (o.d) inhaled
16310552|NCT00567996|Drug|Salmeterol 50 μg|Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
16310553|NCT00567996|Drug|Placebo to Indacaterol|Placebo to Indacaterol inhaled via SDDPI.
16310554|NCT00567996|Drug|Placebo to Salmeterol|Placebo to salmeterol delivered via a proprietary dry powder inhaler
16310555|NCT00567983|Drug|Restasis|Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
16310556|NCT00567983|Drug|Endura|Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
16310557|NCT00567970|Procedure|quality-of-life assessment|
16310558|NCT00567970|Radiation|stereotactic body radiation therapy|
16310559|NCT00567957|Drug|Remifentanil|1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion
16310560|NCT00567957|Drug|Saline|same volume iv bolus before induction followed by same volume infusion
16310561|NCT00567944|Device|BrainPort Balance Device|The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.
16310562|NCT00567931|Drug|1-methyl-d-tryptophan|Given orally
16310563|NCT00567931|Other|pharmacological study|Correlative studies
16310564|NCT00567931|Other|laboratory biomarker analysis|Correlative studies
16310565|NCT00567918|Drug|FK506|Ophthalmic suspension
16310566|NCT00567905|Dietary Supplement|Green tea extract|main content is epigallocatechin gallate (EGCG, 58%)
16310567|NCT00567892|Device|rTMS|"Stimulation Settings:
~Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains)"
16310568|NCT00567879|Drug|Panobinostat|Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.
16310569|NCT00567879|Drug|Trastuzumab|Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.
16310570|NCT00567866|Drug|Quetiapine|50 or 100 mg of quetiapine orally
16310571|NCT00567853|Device|Implantation of the MEMO 3D Annuloplasty Ring|Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
16310572|NCT00567840|Drug|PA-824|200 mg, 600 mg, 100 mg, 1200 mg qd
16310573|NCT00567814|Drug|Metyrapone|Twice daily
16310574|NCT00567814|Drug|Oxazepam|Twice Daily
16310575|NCT00567814|Drug|Placebo|Twice daily
16310576|NCT00567801|Procedure|conventional embolectomy/thrombectomy|
16310577|NCT00567801|Procedure|embolectomy/thrombectomy with controlled reperfusion|
16310578|NCT00567788|Drug|Latanoprost-Bimatoprost|latanoprost 0.005% once daily followed by bimatoprost 0.03%
16310579|NCT00567788|Drug|Bimatoporost-Latanoprost|bimatoprost 0.03% once daily followed by latanoprost 0.005%
16310580|NCT00567775|Drug|human insulin|
16310581|NCT00567775|Drug|inhaled human insulin|
16310582|NCT00567762|Drug|FK506|Opthalmic suspension
16310583|NCT00567762|Drug|placebo|placebo eye drops
16310584|NCT00567736|Drug|Disci/Rhus toxicodendron comp.®|s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
16310585|NCT00567736|Drug|placebo solution|s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
16310586|NCT00567710|Drug|BL - 1020|10 mg/day
16310587|NCT00567710|Drug|BL - 1020|BL 1020 20-30 mg/day
16310588|NCT00567710|Drug|Placebo|Capsules
16310589|NCT00567710|Drug|Risperidone|Capsules
16310590|NCT00567697|Drug|ranibizumab|0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
16310591|NCT00567697|Drug|ranibizumab|Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
16310592|NCT00567684|Device|Computed Tomography Urography (CTU)|CTU performed at least a day before or after the IVU procedure.
16310595|NCT00567671|Procedure|Sham comparator|Sham treatment
16310596|NCT00567658|Drug|Esomeprazole|Esomeprazole or Nexium 40 mg BID is given for four months.
16310597|NCT00567606|Other|risedronate, calcium/vit D, strength weight training|G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine. G2 group receives the calcium, vitamin D, and risedronate, but do not participate in strength/weight training exercises.
16310598|NCT00567593|Drug|Rosiglitazone|8mg tablet once a day for 14 days
16310599|NCT00567580|Radiation|PBRT|1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.
16310600|NCT00567580|Radiation|PLNRT|1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.
16310601|NCT00567580|Drug|AA|Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.
16310602|NCT00567580|Drug|LHRH agonist|Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.
16310603|NCT00567567|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16310604|NCT00567567|Drug|Carboplatin|Given IV
16310605|NCT00567567|Drug|Cisplatin|Given IV
16310606|NCT00567567|Drug|Cyclophosphamide|Given IV
16310607|NCT00567567|Drug|Doxorubicin Hydrochloride|Given IV
16310608|NCT00567567|Drug|Etoposide|Given IV
16310609|NCT00567567|Radiation|External Beam Radiation Therapy|Undergo EBRT
16310610|NCT00567567|Biological|Filgrastim|Given IV or SC
16310611|NCT00567567|Drug|Isotretinoin|Given orally
16310612|NCT00567567|Other|Laboratory Biomarker Analysis|Correlative studies
16310613|NCT00567567|Drug|Melphalan|Given IV
16310614|NCT00567567|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16310615|NCT00567567|Other|Pharmacological Study|Correlative studies
16310616|NCT00567567|Drug|Thiotepa|Given IV
16310617|NCT00567567|Drug|Topotecan Hydrochloride|Given IV
16310618|NCT00567567|Drug|Vincristine Sulfate Liposome|Given IV
16310619|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel|
16310620|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + bevacizumab|
16310621|NCT00567554|Drug|paclitaxel|
16310622|NCT00567554|Drug|paclitaxel + everolimus (RAD001)|
16310623|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + trastuzumab|
16310624|NCT00567554|Drug|epirubicin - cyclophosphamide / docetaxel + lapatinib|
16310625|NCT00567541|Device|Battery Powered Microneuromodulator (BBPM)|The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).
16310626|NCT00567528|Drug|Ibuprofen|Apply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
16310627|NCT00567528|Drug|ibuprofen|Apply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
16310628|NCT00567515|Device|AtriCure LAA Exclusion System|Placement of clip of LAA.
16310629|NCT00567489|Drug|Physioneal|Physioneal 40 or Physioneal 35
16310630|NCT00567489|Drug|Dianeal|Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
16310631|NCT00567489|Drug|Extraneal|7.5% Icodextrin
16310632|NCT00567489|Drug|Nutrineal|Amino Acids 1.1%
16310633|NCT00567476|Drug|Omalizumab|Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.
16310634|NCT00567476|Drug|Inhaled corticosteroids (ICS)|Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent
16310635|NCT00567476|Drug|Long-acting beta 2-adrenergic agonist (LABA)|Fixed dose of LABA as prescribed prior to study entry
16310636|NCT00567476|Drug|Short-acting beta 2-adrenergic agonist (SABA)|Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.
16310637|NCT00567463|Device|Fluticasone|Fluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time
16310638|NCT00567450|Drug|ropivacaine|30ml of a mixture of ropivacaïne 0.75%
16310639|NCT00567450|Drug|ropivacaine plus mepivacaine|30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
16310640|NCT00567437|Other|NT-pro-BNP levels|pre- and post-exercise NT-pro-BNP levels
16310641|NCT00567424|Drug|GW273225|
16310642|NCT00567411|Drug|brimonidine 0.1%|1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
16310643|NCT00567411|Drug|Apraclonidine 0.5%|1 drop applied 1 hour prior to SLT
16310644|NCT00567398|Drug|Dianeal|Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)
16310645|NCT00567398|Drug|Physioneal|Physioneal 40 or Physioneal 35
16310646|NCT00567398|Drug|Extraneal|Extraneal - 7.5% Icodextrin
16310647|NCT00567398|Drug|Nutrineal|Nutrineal - 1.1% Amino Acids
16310648|NCT00567385|Drug|somatropin|
16310649|NCT00567372|Drug|bevacizumab (Sub-tenon´s injection)|a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)
16310650|NCT00567359|Drug|Erlotinib|Oral drug taken daily around the same time. Starting dose is 150mg once daily.
16310651|NCT00567346|Drug|Oralgen|Patients will receive drops of grass pollen immunotherapy sublingually
16310652|NCT00567346|Drug|grass pollen extract|Patients will receive matching placebo sublingually
16310653|NCT00567333|Other|Chiropractic care|A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.
16310654|NCT00567333|Other|Multidisciplinary, integrative care|A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.
16310655|NCT00567320|Drug|Varenicline|Varenicline up to 2 mg a day
16310656|NCT00567320|Drug|Sugar pill or Placebo|Placebo
16310657|NCT00567307|Drug|Red Heart Pill 2b (Polypill)|Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
16310658|NCT00567307|Other|Standard Practice|Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions
16310659|NCT00567294|Behavioral|Mailed education|Mailed education materials on osteoporosis and medication use over a 1-year period
16310660|NCT00567294|Behavioral|Telephone coaching program for patients|A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
16310661|NCT00567294|Behavioral|Medication adherence alert program for doctors|Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.
16310662|NCT00567281|Device|Magstim Rapid 2 system triggering Magstim Super Rapid system|Week 1 treatment includes rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
16310663|NCT00567281|Device|Magstim Rapid-2 system triggering Magstim Super Rapid system|Week 1 includes repetitive rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with sham rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, sham rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
16310664|NCT00567268|Drug|Gabapentin|"GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan.
~Dosage, frequency: According to Japanese LPD, Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
~Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration."
16310665|NCT00567255|Drug|Naltrexone SR 32 mg/bupropion SR 360 mg/day|
16310666|NCT00567255|Drug|Placebo|
16310667|NCT00567255|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
16310668|NCT00567242|Behavioral|Word-finding with intention component|Word-finding trials (picture-naming) with intention manipulation (initiating word-finding trials with a complex left-hand movement). 8 (or more) baseline sessions over 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
16310669|NCT00567242|Behavioral|Word-finding with no intention component|Word-finding trials with no intention manipulation. 8 (or more) baseline sessions in 4 days followed by 30 treatment sessions (2 sessions/day, 5 days/week for 3 weeks).
16310670|NCT00567229|Biological|rituximab|
16310671|NCT00567229|Drug|lenalidomide|
16310672|NCT00567229|Genetic|microarray analysis|
16310673|NCT00567229|Other|flow cytometry|
16310674|NCT00567229|Other|laboratory biomarker analysis|
16310675|NCT00567216|Drug|Nadolol|Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
16310676|NCT00567203|Drug|PF-3463275|PF-3463275 10mg
16310677|NCT00567203|Drug|PF-3463275|PF-3463275 25mg
16310678|NCT00567203|Drug|Placebo|Placebo
16310679|NCT00567190|Drug|Pertuzumab|Pertuzumab was administered as an intravenous (IV) loading dose of 840 milligrams (mg) q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 420 mg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
16310680|NCT00567190|Drug|Placebo|Placebo (matching pertuzumab) was administered intravenously.
16310681|NCT00567190|Drug|Trastuzumab|Trastuzumab was administered as an IV loading dose of 8 milligrams per kilogram (mg/kg) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 6 mg/kg q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination.
16310682|NCT00567190|Drug|Docetaxel|Docetaxel was administered as an IV dose of 75 milligrams per square meter of body surface area (mg/m^2) q3w on Day 2 of Cycle 1 (1 Cycle length = 21 days), and 75 mg/m^2 (up to 100 mg/m^2 as per treating physician discretion) q3w on Day 1 of subsequent cycles until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. On or prior to Cycle 6, docetaxel was only to be discontinued for progressive disease or unmanageable toxicity. After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician.
16310683|NCT00567177|Drug|Restasis, Refresh Plus|Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening
16310684|NCT00567164|Drug|EE20/DRSP (BAY86-5300)|Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
16310685|NCT00567164|Drug|EE20/DRSP (BAY86-5300)|Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
16310686|NCT00567164|Drug|EE20/DRSP (YAZ, BAY86-5300)|Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
16310687|NCT00567112|Drug|10 mg MK-0941 DFC (fasted)|single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
16310688|NCT00567112|Drug|10 mg MK-0941 OCT (after meal)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal
16310689|NCT00567112|Drug|10 mg MK-0941 OCT (before meal)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
16310690|NCT00567112|Drug|10 mg MK-0941 OCT (fasted)|single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
16310691|NCT00567099|Drug|Aripiprzole|"Dosage form, dosage, frequency and duration:
~Aripiprazole 5-30 mg tabs po qday x 3 months"
16310692|NCT00567086|Drug|TEZAMPANEL|Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
16310693|NCT00567060|Drug|Piracetam|
16310694|NCT00567047|Drug|vildagliptin|
16310695|NCT00567034|Drug|naltrexone|50mg naltrexone, 1 tablet a day for 12 weeks.
16310696|NCT00567034|Drug|placebo|lactose placebo, 1 capsule every day for 12 weeks
16310697|NCT00567008|Drug|varenicline|1.0 mg BID for 8 weeks
16310698|NCT00567008|Drug|placebo|placebo BID for 8 weeks
16310699|NCT00566995|Drug|ZACTIMA (Vandetanib) (ZD6474)|
16310700|NCT00566982|Drug|Ospemifene 60 mg|60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
16310701|NCT00566982|Drug|Placebo|Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
16310702|NCT00566969|Drug|sugar pill|Subjects randomized to placebo, carvedilol 25mg or 50mg
16310703|NCT00566969|Drug|Carvedilol 25 mg|subjects randomized to placebo, carvedilol 25mg or 50mg
16310704|NCT00566969|Drug|Carvedilol 50 mg|subjects randomized to placebo, carvedilol 25mg or 50mg
16310705|NCT00566956|Procedure|Hydrosalpinx needle aspiration to arm 1|For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded
16310706|NCT00566943|Device|PSD Veritas Collagen Matrix|Roux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss.
16310707|NCT00566943|Procedure|Roux-en-Y gastric by-pass surgery with no buttress|Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery.
16310708|NCT00566930|Other|spinal manipulation|Monthly cervical spinal manipulation
16310709|NCT00566930|Other|Spinal manipulation + exercises|Monthly cervical spine manipulation and daily home exercises
16310710|NCT00566917|Procedure|Anterior colporrhaphy|Standardised colporrhaphy of the anterior vaginal wall
16310711|NCT00566917|Procedure|Anterior PROLIFT|Transvaginal mesh surgery of the anterior vaginal wall
16310712|NCT00566904|Drug|Epikeia coatings with aspirin|Applied to affected skin area using a roll-on ball applicator
16310713|NCT00566904|Drug|Epikeia coatings with lidocaine|Applied to affected skin area using a roll-on ball applicator
16310714|NCT00566904|Other|Epikeia coatings alone|Applied to affected skin area using a roll-on ball applicator
16310715|NCT00566891|Drug|tirofiban|tirofiban high dose bolus 25µ/Kg
16310716|NCT00566891|Drug|Clopidogrel|
16310717|NCT00566878|Biological|alglucosidase alfa|At least one infusion of alglucosidase alfa post partum
16310718|NCT00566865|Drug|placebo for gemfibrozil|mitiglinide + placebo for gemfibrozil 600 mg bid
16310719|NCT00566865|Drug|gemfibrozil|Mitiglinide + 600 mg gemfibrozil bid
16310720|NCT00566852|Drug|Memantine|Patients began taking memantine(by mouth) while receiving radiation therapy. Patients continued taking memantine for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
16310721|NCT00566852|Other|Placebo|Patients began taking placebo(by mouth) while receiving radiation therapy. Patients continued taking placebo for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.
16310722|NCT00566852|Radiation|Whole brain radiation therapy|Whole brain radiation therapy (WBRT) once a day (2.5Gy), five days a week (Monday to Friday) for three weeks, for total fifteen treatments and 37.5 Gy
16310723|NCT00566839|Procedure|awake nonresectional LVRS|Thoracoscopic nonresectional lung volume reduction surgery carried out in awake patients under sole epidural anesthesia through plication of most emphysematous target areas of the lung
16310724|NCT00566839|Procedure|Nonawake resectional LVRS|Thoracoscopic lung volume reduction surgery carried out under general anesthesia and one-lung ventilation through nonanatomic resection of the most emphysematous target areas of the lung
16310725|NCT00566826|Behavioral|Patient support sessions|Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
16310726|NCT00566826|Behavioral|Treatment as usual|Treatment as usual includes standard care for TKR surgery rehabilitation.
16310727|NCT00566813|Drug|Islet Cell Transplant|1-3 allogeneic islet transplants; two doses of basiliximab 20 mg iv.; sirolimus po trough levels 10-15 ng/ml X 3 months, then 7-10 ng/ml; tacrolimus po trough levels 3-6 ng/ml
16310728|NCT00566813|Drug|Islet Cell Transplant plus|1-3 allogeneic Islets of Langerhans transplantations; two doses of basiliximab 20 mg iv.; sirolimus po daily to maintatin serum levels 12-15 ng/mL for 3 months, and 7-10 ng/mL thereafter; tacrolimus po twice daily to maintain serum levels 3-6 ng/mL; etanercept 50 mg IV before islet transplant, 25 mg subcutaneously post-transplant days 3, 7, 10; exenatide subcutaneously 5 mcg pre-transplant and twice daily for I week, then increased to 10-mcg twice daily for 6 months after the last islet transplant.
16310729|NCT00566800|Drug|erlotinib hydrochloride|
16310730|NCT00566800|Other|laboratory biomarker analysis|
16310731|NCT00566800|Procedure|biopsy|
16310732|NCT00566787|Device|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
16310733|NCT00566774|Other|Full drug coverage|Patients randomized to first-dollar coverage will have their pharmacy benefits changed so that they have no out-of-pocket costs for any beta-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) antagonist, or statin for every subsequent prescription after randomization. All co-pays and co-insurance will be waived at the point of care (i.e. pharmacy) as will any contribution that the cost of these drugs contributes to a patient's deductible
16310734|NCT00566774|Other|Usual coverage|Patients randomized to usual coverage will have no change in their existing benefits
16310735|NCT00566761|Drug|bevacizumab and triamcinolone|three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2
16310736|NCT00566735|Drug|Razadyne|The starting dose of study medication is 4 mg twice a day
16310737|NCT00566735|Drug|Placebo|4 mg, 2 times a day
16310738|NCT00566722|Biological|adalimumab|Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
16310739|NCT00566709|Procedure|Red blood cells transfusion|Patients will be transfused (one to one red blood cells unit transfusion)
16310740|NCT00566696|Device|CliniMACS|Miltenyi Biotec CliniMACS stem cell selection device
16310741|NCT00566696|Procedure|Stem cell transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
16310742|NCT00566696|Drug|Fludarabine|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310743|NCT00566696|Drug|Thioplex®|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310744|NCT00566696|Drug|L-phenylalanine mustard|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310745|NCT00566696|Drug|Mycophenolate mofetil|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310746|NCT00566696|Drug|Rituxan™|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310747|NCT00566696|Drug|Alemtuzumab|After January 2010, due to the unavailability of muromonab, transplant recipients received a conditioning regimen consisting of systemic chemotherapy and antibodies, including alemtuzumab.
16310748|NCT00566696|Drug|Cyclophosphamide|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310749|NCT00566696|Drug|Anti-thymocyte globulin (Rabbit)|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310750|NCT00566696|Drug|G-CSF|Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
16310751|NCT00566696|Drug|Muromonab|Prior to January 2010, transplant participants received a conditioning regimen consisting of systemic chemotherapy and antibodies, including muromonab. Muromonab became unavailable from the manufacturer at that time and was replaced by alemtuzumab.
16310752|NCT00566683|Drug|diazemuls, pethidine|5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine
16310753|NCT00566683|Drug|Propofol and Alfentanil|Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time
16310754|NCT00566657|Biological|riferminogene pecaplasmid|"Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid
~Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated"
16310755|NCT00566657|Biological|Placebo (for riferminogene pecaplasmid)|"Formulation: 5 ml glass vials containing 2,5 ml placebo
~Route: IM injection of 2.5 mL in the ischemic leg to be treated"
16310756|NCT00566644|Device|levonorgestrel-releasing intrauterine system|
16310757|NCT00566644|Other|questionnaire administration|
16310758|NCT00566644|Procedure|observation|
16310759|NCT00566631|Drug|Paliperidone|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
16310760|NCT00566618|Drug|Dasatinib|"Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
~Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I."
16310761|NCT00566618|Drug|Zoledronic Acid|"Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort.
~Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I."
16310762|NCT00566605|Procedure|Penetrating keratoplasty with IntraLase|penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
16310763|NCT00566605|Procedure|Penetrating keratoplasty with vacuum trephine|Group 2 - penetrating keratoplasty with vacuum trephine
16310849|NCT00565968|Genetic|protein expression analysis|
16310764|NCT00566592|Other|oral ethanol, overnight|Oral ethanol before bedtime to achieve approximate BAL of 0.08%
16310765|NCT00566592|Other|IV ethanol|IV ethanol before bedtime to achieve approximate BAL of 0.08%
16310766|NCT00566592|Other|soda water|Oral Placebo before bedtime to achieve approximate BAL of 0.00%
16310767|NCT00566592|Other|soda water|Oral Placebo to achieve approximate daytime BAL of 0.00%
16310768|NCT00566579|Procedure|Cryotherapy|Double freezing technique
16310769|NCT00566566|Other|sample without DNA|family history, anthropometric measurements and blood sampling
16310770|NCT00566553|Dietary Supplement|Grape Seed Extract|200 mg dose daily for 12 weeks.
16310771|NCT00566553|Dietary Supplement|Grape Seed Extract|400 mg dose daily for 12 weeks.
16310772|NCT00566553|Dietary Supplement|Grape Seed Extract|600 mg dose daily for 12 weeks.
16310773|NCT00566553|Dietary Supplement|Grape Seed Extract|800 mg dose daily for 12 weeks.
16310774|NCT00566540|Drug|Cisplatin|Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.
16310775|NCT00566540|Drug|Paclitaxel|Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10
16310776|NCT00566540|Radiation|Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation|Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.
16310777|NCT00566540|Procedure|Triple endoscopy and biopsy|Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.
16310778|NCT00566527|Biological|ProQuad® manufactured with recombinant Human Albumin (rHA)|A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).
16310779|NCT00566514|Dietary Supplement|D-ribose|5 grams administered orally TID
16310780|NCT00566514|Other|dextrose|5 grams orally TID
16310781|NCT00566501|Drug|23 mg SR in Study 326|Patients will receive 23 mg donepezil SR orally, once daily for 12 months.
16310782|NCT00566501|Drug|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
16310783|NCT00566488|Biological|Thymus/Parathyroid Transplantation|Thymus tissue, thymus donor, mother of thymus donor, & parental parathyroid donor screened for transplant safety. Depending on T cell phenotype & function, subjects were given 1 of 2 immunosuppression regimes. All received rabbit anti thymocyte globulin pretransplantation. Others also received cyclosporine pre & post-transplantation. The thymus dose was over 0.2 grams/kg recipient weight. Thymus transplant occurred in operating room; thymic slices were placed in quadriceps. Parathyroid harvest was done under general anesthesia. One parathyroid gland was minced and placed in quadriceps muscle. There was no dose in mg. An open biopsy of thymus allograft was done 2-3 months post-transplant. Biopsy tissue was examined by immunohistochemistry to evaluate for thymopoiesis & graft rejection.
16310784|NCT00566475|Other|telemedicine|School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent
16310785|NCT00566462|Drug|perampanel|2 mg/d for 14 days followed by 4 mg/d for 14 days
16310786|NCT00566462|Drug|placebo|Matching placebo for for 14 days followed by 4 mg/d for 14 days
16310787|NCT00566449|Drug|Placebo|one dose daily for 4 weeks
16310788|NCT00566449|Drug|JNJ-31001074|10 mg daily for 4 weeks
16310789|NCT00566449|Drug|JNJ-31001074|30 mg daily for 4 weeks
16310790|NCT00566436|Procedure|Remote endarterectomy of the superficial femoral artery|Exposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch.
16310791|NCT00566436|Procedure|Suprageniculate femoropopliteal bypass|Groin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping)
16310792|NCT00566423|Other|Blood draw|Venous and Arterial Blood draw samples; 6 Minute Walk test
16310793|NCT00566410|Drug|Dichloroacetate|Continuous daily oral dosage (bid).
16310794|NCT00566397|Drug|PF-04494700|15 mg for 6 days followed by daily dosing of 5mg
16310795|NCT00566397|Drug|PF-04494700|60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
16310796|NCT00566397|Drug|Placebo|Placebo
16310797|NCT00566384|Drug|Dehydroepiandrosterone, BAY86-5314|Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
16310798|NCT00566384|Drug|Placebo|Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
16310799|NCT00566371|Drug|atomoxetine|Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.
16310800|NCT00566371|Drug|placebo|placebo
16310845|NCT00565981|Drug|Alemtuzumab|subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose
16310846|NCT00565968|Drug|melphalan|
16310847|NCT00565968|Drug|sorafenib tosylate|
16310801|NCT00566358|Procedure|Duodenal exclusion surgery|Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create an excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
16310802|NCT00566345|Biological|Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)|Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
16310803|NCT00566345|Biological|Phosphate buffered saline|Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
16310804|NCT00566332|Drug|Chlorambucil|Chlorambucil 8 mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months By oral route
16310805|NCT00566332|Drug|Fludarabine|Fludarabine 40 mg/m² (30 mg/m² if patient aged more than 75 years old) 5 days every 28 days during 6 cycles By oral route
16310806|NCT00566319|Behavioral|PREPARE with pedometer|Structured educational programme with pedometer use
16310807|NCT00566319|Behavioral|PREPARE|Structured educational programme
16310808|NCT00566306|Other|Polyhexamethyleneguanidine (PHMG)|6 months in 3 experimental wards
16310809|NCT00566280|Procedure|Molecular Breast Imaging|A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 20 mCi of 99m Tc-sestamibi.
16310810|NCT00566267|Drug|simvastatin 20 mg/ezetimibe|see protocol
16310811|NCT00566254|Drug|Zonisamide|8mg/kg per day for approximately 24 weeks.
16310812|NCT00566254|Drug|Placebo|
16310813|NCT00566241|Drug|recombinant human IGF-1|rhIGF-1
16310814|NCT00566241|Drug|Placebo|Placebo
16310815|NCT00566228|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous stem cell transplantation
16310816|NCT00566228|Procedure|leukapheresis|Stem cells collected
16310817|NCT00566215|Procedure|Duodenal exclusion plus omentectomy|"Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
~Additionally, total omentectomy is performed."
16310818|NCT00566215|Procedure|Duodenal exclusion without omentectomy|Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
16310819|NCT00566202|Drug|Placebo|Form= capsule, route= oral use. Administration once daily for 8 weeks.
16310820|NCT00566202|Drug|Escitalopram|Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
16310821|NCT00566202|Drug|JNJ-18038683|Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
16310822|NCT00566189|Procedure|Roux-en-Y Bypass Gastroplasty|Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
16310823|NCT00566176|Device|Surgical Ablation using the AtriCure Bipolar System|Surgical Ablation using the AtriCure Bipolar System
16310824|NCT00566150|Drug|Levetiracetam|Flexible dose up to 2500mg per day, for 6 weeks.
16310825|NCT00566150|Drug|Placebo|Flexible dose up to 2500mg per day, for 6 weeks.
16310826|NCT00566124|Drug|Insulin detemir|0.4 U/kg bw insulin detemir injected s.c. in the thigh.
16310827|NCT00566124|Drug|Insulin glargine|0.4 U/kg bw insulin glargine injected s.c. in the thigh
16310828|NCT00566124|Drug|Insulatard|0.4 U/kg bw NPH insulin injected s.c. in the thigh
16310829|NCT00566111|Drug|ceftriaxone|2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
16310830|NCT00566111|Drug|Saline solution|Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
16310831|NCT00566098|Biological|MILs|
16310832|NCT00566098|Drug|Melphalan|
16310833|NCT00566098|Biological|PCV13|
16310834|NCT00566085|Procedure|Molecular Breast Imaging|A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.
16310835|NCT00566072|Behavioral|instructions and coaching|instructions and coaching or no intervention on the use and intake of ganciclovir
16310836|NCT00566046|Drug|Levetiracetam|1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
16310837|NCT00566046|Drug|Placebo|1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
16310838|NCT00566033|Behavioral|Audit-driven intervention|Patients included in this arm will undergo to the multi-method quality improvement intervention (intensive intervention) that adds practice visits, telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination and feedback on demand used in the less intensive intervention.
16310839|NCT00566020|Drug|BW430C (lamotrigine)|lamotrigine 50mg/day-400mg/day
16310840|NCT00566007|Procedure|Discectomy/ micro discectomy|Standard discectomy or micro discectomy
16310841|NCT00566007|Drug|Ozone therapy|Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic
16310842|NCT00566007|Drug|Oxygen therapy|Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic
16310843|NCT00565994|Procedure|Blood Draw|For patients undergoing routine hemodialysis for chronic renal failure, 5-10 ml of blood will be removed from the dialysis tubing during vascular access. All other subjects will have 5-10 ml of blood drawn by routine venipuncture.
16310844|NCT00565981|Drug|Fludarabine phosphate|orally, 40 mg/m2 d1-3 q4w, x4 cycles
16310850|NCT00565968|Genetic|western blotting|
16310851|NCT00565968|Other|pharmacological study|
16310852|NCT00565955|Drug|montelukast|"Standard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows:
~5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid."
16310853|NCT00565955|Drug|Placebo|The patients will receive placebo tablets.
16310854|NCT00565942|Procedure|Integrative care|In short, integrative care was up to 10 complementary therapy treatments delivered to the patient in addition to the usual care over an intervention period of up to 12 weeks. The integrative care was provided by a multidisciplinary team coordinated by a gate keeping general practitioner with clinical knowledge and experience of CTs and senior licensed/certified CT providers representing Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong.
16310855|NCT00565942|Procedure|Usual care|The usual care treatment was coordinated by the patient's general practitioner and complied with the clinical practice routines at the participating primary care units. Conventional procedures included but were not exclusive to advice, prescription of drugs, sick leave and physiotherapy/physical therapy. There were no constraints to the provided usual care as the study aimed to pragmatically reflect the general practitioners' standard care and treatment as usual.
16310856|NCT00565929|Drug|Placebo|Sterile saline (0.9%).
16310857|NCT00565929|Biological|MVA-BN|The smallpox vaccine is a liquid frozen solution formulated to contain 0.605 mg Tris and 4.090 mg sodium chloride (NaCl) per 0.5 mL dose. The concentration of the virus will be 1 X 10^8 tissue culture infectious dose 50 (TCID 50) per 0.5 mL dose and may be diluted in a solution of 0.9% saline prior to vaccination. Smallpox vaccine administered in 2 doses approximately 28 days apart in one of the following doses: 1X10^7 or 1X10^8 TCID 50.
16310858|NCT00565916|Drug|Estrogen|"Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo.
~Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO)."
16310859|NCT00565916|Drug|Progesterone|Estrogen plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken.
16310860|NCT00565916|Drug|Placebo|Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.
16310861|NCT00565890|Drug|thyroxine|thyroxine at the dose of 5 μg/kg-wt /day
16310862|NCT00565877|Other|Ultrasound inspection|post-PICC insertion Ultrasound inspection of the ipsilateral neck for PICC in a malposition (ipsilateral internal jugular vein)
16310863|NCT00565864|Drug|L-thyroxine (L-T4)|L-thyroxine (L-T4) is the intervention for each arm/group. In each arm/group, the dose of L-T4 is adjusted to achieve TSH levels in the randomly assigned arm. L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
16310871|NCT00565838|Procedure|AFS and TVT|Autologous Fascial Sling and Tension- Free Vaginal Tape
16310872|NCT00565812|Drug|SD-6010|200 mg tablets once a day for 2 years
16310873|NCT00565812|Drug|SD-6010|50 mg tablets once a day for 2 years
16310874|NCT00565812|Drug|Placebo|Placebo tablets once a day for 2 years
16310875|NCT00565799|Procedure|Omentectomy|Removing the omentum
16310876|NCT00565799|Other|No intervention|Only LAGB without Omentectomy
16310877|NCT00565786|Device|ArCom® Polyethylene|Argon packaged compression molded polyethylene
16310878|NCT00565786|Device|ArComXL® Polyethylene|Highly crosslinked Ultra High Molecular Weight Polyethylene
16310879|NCT00565773|Drug|Belatacept|Belatacept will be given within 24 hours of transplantation via a peripheral intravenous catheter at a dose of 10mg/kg (actual body weight) infused over 30 mins. The dose will be repeated on study days 4 (post op day 3) and 8 (post op day 7), then every 2 weeks for 5 additional doses. Thereafter, belatacept will be given once every 4 weeks (+/- 3 days) at 10mg/kg through 6 months then at 5mg/kg indefinitely.
16310880|NCT00565773|Drug|Sirolimus|Sirolimus will be started on postoperative day 1 at a dose of 2 mg per day orally. Doses will be adjusted to maintain 24-hour trough levels of 8-10ng/ml until the drug is weaned. Toxicity attributable to sirolimus (e.g., mouth ulcers, arthralgias) will prompt dose reduction to address clinical concerns in this regard. If sirolimus trough levels need to be reduced below 4ng/ml to control drug side effects, the patient will be considered intolerant to the drug and will be changed to other medications.
16310881|NCT00565773|Drug|Alemtuzumab|All participants will receive a single dose of 30 mgs of alemtuzumab on the day of transplantation.
16310882|NCT00565760|Drug|Q8003|Capsules
16310883|NCT00565760|Drug|Placebo|Capsules
16310884|NCT00565747|Device|Test culture|A standard culture medium with added GM-CSF (ready-to-use)
16310885|NCT00565747|Device|Control culture|The same standard culture medium, but without any additions (ready-to-use)
16310886|NCT00565721|Drug|Fluciclatide Injection - (AH111585 (F18))|18F labelled Cyclic RGD peptide PET agent for injection.
16310887|NCT00565708|Other|placebo|Placebo Comparator
16310888|NCT00565708|Drug|Acetylsalicylic acid|Adjuvant Therapy
16310889|NCT00565695|Device|aspheric ReSTOR multifocal intraocular lens (IOL)|Multifocal intraocular lens
16310890|NCT00565682|Drug|etoricoxib 120 mg|etoricoxib 120 mg, tablet, orally, OD
16310891|NCT00565669|Drug|Cyclosporin A Restasis®|
16310892|NCT00565669|Drug|Blink tears|blink tears to be used twice a day
16310893|NCT00565669|Drug|Systane|systane to be used twice a day
16310894|NCT00565656|Drug|BEVACIZUMAB|Administration of Bevacizumab
16310895|NCT00565643|Device|modified sodium hyaluronic acid and carboxymethylcellulose|Adhesion barrier applied at the time of initial cesarean delivery
16310896|NCT00565643|Device|Placebo|Routine abdominal closure without placement of adhesion barrier
16310897|NCT00565630|Device|Vigamox delivered via the device in spray form|Vigamox delivered 4 times, 1 hour prior to cataract surgery
16310898|NCT00565617|Device|Synergy, Epidural cortical stimulation|Epidural cortical stimulation
16310899|NCT00565604|Device|Short Catheter Delivery|For treating incompetent perforator veins of the lower extremities
16310900|NCT00565591|Drug|Albuterol sulfate|Single dose dry powder by inhalation
16310901|NCT00565565|Drug|BAY60-4552|Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
16310902|NCT00565552|Drug|Silicone gel (Dermatix®)|The half one the scar to treat was randomised among patients. After regular cleaning of the skin around the scar one half was thinly creamed with the silicone gel from medial to lateral and let dry for 5 minutes. It was done twice daily.
16310903|NCT00565539|Drug|PEGylated recombinant interleukin 29 (PEG-rIL-29)|subcutaneous administration either weekly or every other week
16310904|NCT00565513|Procedure|blood test|cord blood and maternal milk test
16310905|NCT00565500|Drug|celecoxib|celecoxib capsules 200 mg bid for 1 week
16310906|NCT00565500|Drug|ibuprofen|ibuprofen tablets 600 mg tid for 1 week
16310907|NCT00565500|Drug|placebo|placebo capsules tid for 1 week
16310908|NCT00565487|Drug|Capecitabine, Tarceva|Capecitabine is a self-administered (oral) medication & will be dose escalated and administered in four dose levels: Level I - 600 mg/m2 bid; Level II - 700 mg/m2 bid; Level III - 825 mg/m2 bid; Level IV - 925 mg/m2 bid. Tarceva will be self-administered(orally) in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single agent Tarceva 100 mg/day. Treatment of Capecitabine & Tarceva is continued daily until the completeness of the radiation or toxicity.
16310909|NCT00565474|Drug|Fluvastatin|Graft vasculopathy
16310910|NCT00565461|Biological|heat-labile enterotoxin of E. coli (LT)|37.5ug patch applied on either the deltoid or the thigh
16310911|NCT00565448|Drug|docetaxel|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
16310912|NCT00565448|Drug|cisplatin|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
16310913|NCT00565448|Drug|5-fluorouracil|"Pharmaceutical form:solution for infusion
~Route of administration:intravenous"
16310914|NCT00565422|Drug|Escitalopram|10 mg/day
16310915|NCT00565409|Drug|Etanercept|Subcutaneous (SC), 50 mg, once weekly for 88 weeks
16310916|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
16310917|NCT00565409|Drug|Etanercept|Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
16310918|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
16310919|NCT00565409|Drug|Placebo|Subcutaneous (SC), once weekly from week 36 to week 88.
16310920|NCT00565409|Drug|Methotrexate|"Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
~If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week)."
16310921|NCT00565396|Drug|Fosinopril and Losartan|Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
16310922|NCT00565383|Procedure|Combined spinal-epidural analgesia|Combined spinal-epidural
16310923|NCT00565383|Procedure|Intravenous fentanyl (50mcg)|Intravenous fentanyl
16310924|NCT00565370|Drug|Capecitabine, Cisplatin, Sorafenib|Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
16310925|NCT00565357|Device|Silicone Earplugs|Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first
16310926|NCT00565357|Other|Control|Standard care in the neonatal intensive care unit
16310927|NCT00565331|Drug|Rituximab|single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
16310928|NCT00565331|Drug|Placebo|saline solution
16310929|NCT00565318|Drug|Benfotiamine|3x 300 mg film coated tablet daily (900 mg per day). Duration: 12 weeks.
16310930|NCT00565318|Drug|Placebo|3x 1 film coated tablet daily. Duration: 12 weeks.
16310931|NCT00565305|Behavioral|Healing Touch|Healing Touch (HT) is a non-invasive therapeutic approach to healing which describes its mode of action as using touch to modulate the patient's energy system. The goal of HT is to restore harmony and balance in the patient's energy system to assist the person to self-heal.88 Healing Touch, as used here, refers to the techniques taught in Mentgen's standardized curriculum of Healing Touch offered through Healing Touch International and endorsed by the American Holistic Nurse's Association
16310932|NCT00565305|Radiation|Standard Treatment|4-6 cycles of cytotoxic chemotherapy followed by 5040 cGy of external beam whole breast radiotherapy in 28 fractions usually followed by a boost of 1000-1600 cGy
16310933|NCT00565292|Drug|MK0859|
16310934|NCT00565279|Drug|ASF1057|Twice daily, topical
16310935|NCT00565279|Drug|ASF1057|Twice daily, Topical
16310936|NCT00565266|Drug|tiotropium bromide|tiotropium bromide inhalation powder 18 mcg once daily
16310937|NCT00565266|Drug|salmeterol xinafoate|salmeterol xinafoate inhalation powder 50 mcg twice daily
16310938|NCT00565266|Drug|beclomethasone dipropionate|beclomethasone dipropionate 80 mcg twice daily (1xICS) or 160 mcg twice daily (2xICS)
16310939|NCT00565253|Drug|Inhaled nitric oxide (NO)|20 ppm for 15 minutes
16310940|NCT00565240|Drug|Marvelon|oral contraceptive
16310941|NCT00565240|Drug|Nuvaring|contraceptive vaginal ring
16310942|NCT00565240|Drug|Letrozole|Aromatase Inhibitors
16310972|NCT00564954|Drug|Dex-methylphenidate hydrochloride extended-release (Focalin XR)|20 mg capsule orally once a day for 7 days
16310943|NCT00565227|Drug|vorinostat (suberoylanilide hydroxamic acid)|Vorinostat will be administered by mouth as a pill for the first 14 days on a continuous basis during of each 21-day cycle (2 weeks of treatment, 1 week break).
16310944|NCT00565227|Drug|docetaxel|Docetaxel will be administered as an intravenous infusion (through the vein) on day 4 of each 21-day cycle.
16310945|NCT00565214|Dietary Supplement|Group 1|The treatment plan involves the administration of a combination of 3 vitamins (vitamin C 1000 mg, vitamin E 400 IU, selenomethionine 400 μg) to study volunteers in a 2:1 randomization, Vitamins are to be taken orally, once a day, for a duration of 30 days.
16310946|NCT00565214|Dietary Supplement|Group 2|The treatment plan involves the administration of a combination of 3 placebos to be taken orally, once daily for a duration of 30 days.
16310947|NCT00565201|Drug|Botox and rehab|Patients will BOTOX® (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
16310948|NCT00565201|Drug|Placebo and rehab|Patients will receive placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
16310949|NCT00565188|Drug|Adenosine 5'-triphosphate|Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min
16310950|NCT00565175|Drug|famotidine|Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
16310951|NCT00565175|Drug|Placebo (Microcrystallized cellulose)|Placebo administered in identical capsules as the experimental drug.
16310952|NCT00565162|Drug|Insulin Glargine|Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.
16310953|NCT00565149|Behavioral|PROOF|dietary overfeeding with high, low or normal protein content
16310954|NCT00565136|Device|TOPAS|A mesh sling permanently implanted to increase pelvic floor support
16310955|NCT00565123|Drug|0.5% levofloxacin eye drops|0.5% levofloxacin eye drops three times daily to each eye for 5 days
16310956|NCT00565123|Drug|0.5% levofloxacin eye drops|0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)
16310957|NCT00565110|Behavioral|ADAPt-C intervention|Experimental Arm patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
16310958|NCT00565097|Drug|Placebo|
16310959|NCT00565097|Drug|Lanreotide|
16310960|NCT00565084|Drug|ibuprofen|Patients will receive 800 mg ibuprofen in one of the three treatment periods.
16310961|NCT00565084|Drug|Placebo|Patients will receive placebo to ibuprofen in two of the three treatment periods.
16310962|NCT00565071|Device|Field microscopy and Paracheck Pf®|Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
16310963|NCT00565058|Biological|GTI-2040|GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC
16310964|NCT00565045|Device|Neuromuscular electrical stimulator|"Intervention Characteristics Common to Both Groups
~• 6-week intervention
~Home exercise, daily
~Exercise (at home) 2 sessions/day
~A session consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest
~A set entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions
~Lab therapy, 2x/week
~Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible)."
16310965|NCT00565019|Drug|Triamcinolone Acetonide|"Triamcinolone acetonide will be administered into the cord following surgery with a tuberculin syringe and a 25-gauge needle.
~Doses will range from 60-120 mg depending on extent of the disease.
~Patients will receive injections at 6 weeks and 3 months for persisting nodules or cords.
~PI will determine the dosages. Estimates will be made based on the following:
~Size of nodule/cord: 1-2 cm2, dosage 20-40 mg
~Size of nodule/cord: 2-6 cm2, dosage 40-80 mg
~Size of nodule/cord: 6-10 cm2, dosage 80-100 mg
~Size of nodule/cord: >10 cm2, dosage 100-120 mg"
16310966|NCT00565006|Drug|MK0859|
16310967|NCT00564993|Drug|Dobutamin|10&20 µg/kg/min
16310968|NCT00564980|Procedure|Wafer Procedure|A dorsal approach to the distal ulna is used dividing the extensor retinaculum between the 5th and 6th compartments. The ulnar head is exposed through a transverse capsulotomy. Cartilage and bone are resected to result in slight negative ulnar variance based on the preoperative pronated grip view. The ulnar styloid and TFCC attachments are preserved. The dorsal capsule and retinaculum are repaired in separate layers.
16310969|NCT00564980|Procedure|Ulnar shortening osteotomy|A longitudinal incision of approximately 8 cm is made at the distal third of the ulna along the ulnar border of the forearm. The interval between the flexor carpi ulnaris is used. The ulna is exposed at its distal third preserving the periosteum. Care is taken to protect the sensory branches of the lunar nerve. An oblique osteotomy is performed using a reciprocating saw, removing enough bone to result is slight negative ulnar variance. Fixation and compression at the osteotomy site is achieved using a 5 or 6 hole titanium LC-DCP plate.
16310970|NCT00564967|Behavioral|CBT via the Internet|15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week),
16310971|NCT00564967|Behavioral|CBT group therapy|15 weeks, 1 session/week, (2,5 hours.)
16310973|NCT00564954|Drug|Placebo|orally once a day for 7 days
16310974|NCT00564941|Drug|deferasirox|
16310975|NCT00564928|Drug|IPI-504|IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle
16310976|NCT00564915|Dietary Supplement|Ketogenic diet|Ketogenic diet
16310977|NCT00564902|Drug|3R 3'R Zeaxanthin|8 mg per day during 12 months
16310978|NCT00564902|Dietary Supplement|Lutein|9 mg of Lutein during 12 months
16310979|NCT00564902|Dietary Supplement|Lutein and Zeaxanthin|8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months
16310980|NCT00564889|Drug|cyclophosphamide|300 mg/m^2 days 1, 8 & 15 of a 28 day cycle taken orally with food
16310981|NCT00564889|Drug|dexamethasone|40 mg weekly taken orally
16310982|NCT00564889|Drug|lenalidomide|15 mg daily days 1-21 of a 28 day cycle taken orally with food
16310983|NCT00564876|Drug|Dasatinib|Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.
16310984|NCT00564863|Biological|CS19 expressing ETEC strain|Wild type ETEC strain expressing the colonization faction CS19, and LT and ST enterotoxins.
16310985|NCT00564850|Drug|Triptorelin pamoate 11.25mg (Decapeptyl® SR)|One intra muscular injection at day 1 and month 3.
16310986|NCT00564837|Procedure|Home-based rehabilitation program|Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
16310987|NCT00564837|Procedure|Physiotherapy-supervised rehabilitation program|Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months
16310988|NCT00564824|Drug|Caffeine|Caffeine 200 mg tablet
16310989|NCT00564824|Drug|Placebo|Placebo pills
16310990|NCT00564811|Dietary Supplement|Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)|Agaricus blazei powder, 10 grams/day, for 5 months
16310991|NCT00564785|Drug|Synera(TM)|Synera(TM) patch applied 20 minutes prior to epidural
16310992|NCT00564785|Other|Placebo patch|placebo patch applied 20 minutes prior to epidural
16310993|NCT00564772|Drug|Raltegravir, lopinavir, ritonavir|4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.
16310994|NCT00564759|Drug|retroviral SF71-gp91phox transduced CD34+ cells|autologous ex-vivo retroviral transduced (SF71-gp91phox) CD34+ cells
16310995|NCT00564746|Drug|A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323|"[14C] SB-681323 oral solution, is available as a powder which will be made into a solution of 0.1 milligram/milliliter (0.5 microcurie) [14C] SB-681323 in dextrose and water for injection on the day prior to dosing.
~For a 10 milligram/50 microcurie oral dose of [14C]SB-681323, 100 milliliters of 0.1 milligram/milliliter (0.5 microcurie/milliliter [14C] SB-681323 oral solution will be dosed."
16310996|NCT00564733|Drug|carboplatin|Given IV
16310997|NCT00564733|Drug|docetaxel|Given IV
16310998|NCT00564733|Drug|gemcitabine hydrochloride|Given IV
16310999|NCT00564733|Drug|paclitaxel|Given IV
16311000|NCT00564733|Procedure|computed tomography|Undergo FDG PET/CT
16311001|NCT00564733|Procedure|positron emission tomography|Undergo FDG PET/CT
16311002|NCT00564733|Radiation|fludeoxyglucose F 18|Given IV
16311003|NCT00564733|Other|imaging biomarker analysis|Correlative studies
16311004|NCT00564720|Drug|Gemcitabine|Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
16311005|NCT00564720|Drug|Gemcitabine|Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
16311006|NCT00564720|Drug|Erlotinib|Erlotinib 100 mg by mouth (p.o.), daily until disease progression
16311007|NCT00564720|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
16311008|NCT00564707|Behavioral|Biofeedback therapy|EMG guided biofeedback therapy using standard biofeedback computer software
16311009|NCT00564707|Procedure|Botulinum Toxin Type A Injection|Under EMG guidance Botox is injected directly into the painful levator ani muscle.
16311010|NCT00564694|Procedure|psychosocial assessment and care|
16311011|NCT00564694|Procedure|quality-of-life assessment|
16311012|NCT00564681|Biological|botulinum toxin type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
16311013|NCT00564681|Biological|botulinum toxin type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
16311014|NCT00564681|Drug|Normal Saline|Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
16311015|NCT00564668|Drug|biphasic insulin aspart|
16311016|NCT00564655|Procedure|bupivacaine with epinephrine (mid and upper abdomen)|Patients will receive localized infiltration of local anesthesia (0.25% bupivacaine with epinephrine 1:200,000) at the beginning of the procedure as is current standard practice. Localized anaesthetic of the mid and upper abdomen.
16311017|NCT00564655|Procedure|bupivacaine with epinephrine (transversus abdominis plane)|0.6 cc/kg (to a maximum of 20 ccs) of 0.25% bupivacaine with epinephrine 1:200,000 will be injected into the neuro-vascular plane between the internal oblique and transversus abdominis muscles. Regional anaesthetic block of the transversus abdominis plane.
16311018|NCT00564642|Drug|N Acetylcysteine|1200 mg, BD, 2weeks
16311019|NCT00564629|Drug|Intravenous acetaminophen plus oral placebo|Single dose of 1 gm IV acetaminophen
16311020|NCT00564629|Drug|Oral acetaminophen plus IV placebo|Single dose of 1 g PO APAP
16311021|NCT00564629|Biological|Reference standard endotoxin (RSE)|To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
16311022|NCT00564616|Device|video cell phone|"the voice group received voice CPR instruction via a voice-only cell phone, and the video group received interactive voice and video instruction via a video cell phone"
16311023|NCT00564603|Drug|Dexamethasone Sodium Phosphate Injection|Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
16311024|NCT00564603|Other|0.9% Saline|Saline, in same volume of 2mL
16311025|NCT00564590|Drug|Melatonin|4 mg of Melatonin once a day for 3 months
16311026|NCT00564590|Other|omeprazole|omeprazole 20 mg once a day
16311027|NCT00564590|Drug|Placebo|Placebo once a day
16311028|NCT00564577|Biological|CFA/I and CS17 challenge strain|Wild type ETEC strain expressing the colonization factor CS17, and heat labile (LT) enterotoxin
16311029|NCT00564564|Drug|Quetiapine|Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
16311030|NCT00564564|Drug|Clomipramine|Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
16311031|NCT00564551|Behavioral|High dairy and calcium intake|High intake of low-fat milk product intake (3-4 servings per day) plus one 350 mg calcium supplement per day during 500 kcal/day deficit diet.
16311032|NCT00564551|Behavioral|Usual intake|Usual intake of low milk product intake (1 serving/day) and low calcium intake with a placebo during a 500 kcal/day deficit diet
16311033|NCT00564538|Drug|anti-thymocyte globulin (rabbit)|1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg.
16311034|NCT00564538|Drug|tacrolimus|Tacrolimus will be administered orally on post op day #1 as per standard of care.
16311035|NCT00564525|Drug|Amitriptyline|Medication taken for 4 weeks
16311036|NCT00564525|Drug|Placebo|Medication taken for 4 weeks
16311037|NCT00564512|Biological|Campath|Fludarabine-Cyclophosphamide-Campath (FCCam)
16311038|NCT00564512|Biological|rituximab|Fludarabine-Cyclophosphamide-Rituximab (FCR)
16311039|NCT00564512|Drug|cyclophosphamide|Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)
16311040|NCT00564512|Drug|fludarabine|Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)
16311041|NCT00564486|Drug|IV Placebo|IV, every 6 hours for 24 hours (4 doses total)
16311042|NCT00564486|Drug|IV Placebo|IV, every 4 hours for 24 hours (6 doses total)
16311043|NCT00564486|Drug|IV Acetaminophen|IV, every 6 hours for 24 hours (4 doses total)
16311044|NCT00564486|Drug|IV Acetaminophen|IV, every 4 hours for 24 hours (6 doses total)
16311045|NCT00564473|Behavioral|questionnaire|"questionnaire of demographic and medical data, use of and attituded toward herbal medicine.
~Beck Depression Inventory-Second Edition (BDI-II)- Hebrew Translation"
16311046|NCT00564460|Drug|Finasteride|Finasteride 5 mg PO once daily for 8 weeks prior to TURP
16311047|NCT00564460|Drug|Placebo|Placebo once daily for 8 weeks
16311048|NCT00564447|Drug|Azithromycin|azithromycin topical solution 1% given as a single drop in a single eye
16311049|NCT00564447|Drug|Moxifloxacin|Moxifloxacin topical solution given as a single drop in a single eye
16311050|NCT00564421|Drug|epinastine nasal spray, low concentration, low dose volume|2 sprays in each nostril, dosed twice a day
16311051|NCT00564421|Other|placebo nasal spray|2 sprays in each nostril, dosed twice a day
16311052|NCT00564421|Drug|epinastine nasal spray, low concentration, high dose volume|2 sprays in each nostril, dosed twice a day
16311053|NCT00564421|Drug|epinastine nasal spray, high concentration, low dose volume|2 sprays in each nostril, dosed twice a day
16311054|NCT00564421|Drug|epinastine nasal spray, high concentration, high dose volume|2 sprays in each nostril, dosed twice a day
16311055|NCT00564408|Drug|Carbachol|3 microgram per kg bodyweight infused intravenously
16311056|NCT00564395|Drug|Insulin Detemir mixed with RAI injection|Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection
16311057|NCT00564395|Drug|Insulin Detemir and RAI injection|Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
16311058|NCT00564382|Procedure|Cardiac magnetic Resonance study|Routine cardiac MR study including contrast application
16311059|NCT00564369|Other|CDC HIV testing recommendations|Current vs. prior CDC recommendations
16311060|NCT00564356|Procedure|cataract surgery with phacoemulsification|removal of cataract with phacoemulsification technique
16311061|NCT00564343|Other|water based training program to improve balance|The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.
16311062|NCT00564330|Drug|Esomeprazole|20mg bid
16311063|NCT00564330|Drug|Placebo|Placebo bid
16311064|NCT00564317|Behavioral|KIDNET|Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events
16311065|NCT00564317|Behavioral|Meditation/Relaxation|a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
16311066|NCT00564291|Other|Examination with an OCT device|
16311067|NCT00564278|Drug|Standard antidepressant therapy (SADT)|Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
16311068|NCT00564278|Behavioral|Motivational antidepressant therapy (MADT)|The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
16311069|NCT00564265|Other|Observation|Not applied
16311070|NCT00564252|Drug|topical finasteride|0.2%topical(cream)finasteride twice a day for six months
16311071|NCT00564239|Behavioral|Cognitive Behavioral Group Therapy|12 children group sessions, 8 parent group sessions
16311072|NCT00564239|Behavioral|Cognitive Behavioral Group Therapy|12 children group sessions
16311073|NCT00564226|Drug|SSR240600C|oral administration
16311074|NCT00564226|Drug|tolterodine|oral administration
16311075|NCT00564226|Drug|placebo|oral administration
16311076|NCT00564213|Drug|PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds|Mitomycin 0.02%
16311077|NCT00564200|Drug|Bortezomib|"PREACONDICIONAMIENTO:
~2 cycles of 21 days : Velcade days: 1, 4, 8 and 11
~1 cycle of 13 days : Velcade days 1, 4, 8 and 11
~ACONDICIONAMIENTO:
~- Day -2: Velcade
~POSTRANSPLANTATION:
~2 cycles of 21 days : Velcade days 1, 8 and 15
~5 cycles of 56 days : Velcade days 1, 8 and 15"
16311078|NCT00564200|Drug|dexamethasone|"PREACONDICIONAMIENTO:
~- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11"
16311079|NCT00564200|Drug|Fludarabine|"ACONDICIONAMIENTO:
~- Days -9 al -5: Fludarabine"
16311080|NCT00564200|Drug|Melphalan|"ACONDICIONAMIENTO:
~- Days -4 and -3: Melphalan."
16311081|NCT00564187|Drug|Irbesartan|"Irbesartan: 150mg tablets
~Dosage: Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
~• 150mg/day for normalized patients and patients responding non normalized randomized in the group A"
16311082|NCT00564187|Drug|Irbesartan|"Irbesartan: 150mg tablets
~Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks:
~• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B"
16311083|NCT00564174|Drug|Low molecular weight heparin and low dose aspirin|Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery
16311084|NCT00564174|Drug|Low dose aspirin|81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
16311085|NCT00564148|Drug|Avastin|2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
16311086|NCT00564135|Procedure|on Foley time|A-no Foley B-remove Foley at 7AM in the morning of postoperative day 1 C-remove Foley at 7AM in the morning of postoperative day 2
16311087|NCT00564122|Device|Artificially-Intelligent Stethoscope|After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.
16311088|NCT00564122|Other|Physical Examination|A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.
16311089|NCT00564109|Procedure|retrospective Observation|retrospective Observation
16311090|NCT00564096|Device|DEEP TMS H1 coil|"A new coil (H-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS."
16311091|NCT00564096|Device|Deep H1 coil TMS|"A new coil (H-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS."
16311092|NCT00564083|Procedure|sacral colpopexy|This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum)
16311093|NCT00564070|Behavioral|Enhanced treatment as usual plus adherence training|The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
16311094|NCT00564070|Behavioral|Enhanced treatment as usual plus CBT-AD|The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.
16311095|NCT00564057|Drug|candesartan|tablet 8-16 mg once daily, one year
16311096|NCT00564057|Drug|lercanidipine|tablets 10-20 mg once daily, one year
16311097|NCT00564044|Procedure|excision of the protruding mesh and its surrounding vaginal tissue|A piece of vaginal tissue 12mm*5mm*3mm in sized (for control group) and another piece of vaginal tissue combined with protruding mesh of the same size (for study group) will be obtained respectively for each of the two arms during intervention.
16311098|NCT00564031|Drug|Femanest|2mg/day
16311099|NCT00564031|Drug|gestapuran|5mg/day
16311100|NCT00564031|Drug|placebo|daily
16311101|NCT00564031|Drug|Femanest plus Gestapuran|combined daily
16311102|NCT00564018|Drug|Insulin detemir|Dosage adjusted to meet age-specific glycemic goals throughout course of study.
16311103|NCT00564018|Drug|Glargine|Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
16311104|NCT00564018|Drug|NPH|Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
16311105|NCT00564005|Other|Constraint-induced therapy (CIT)|restraint of the unaffected arm and practice of the affected arm
16311106|NCT00564005|Other|Bilateral arm training (BAT)|bilateral symmetric, repetitive arm training
16311107|NCT00564005|Other|Combined therapy (CT)|combined different treatment approaches
16311108|NCT00564005|Behavioral|Control intervention|Conventional treatment program
16311109|NCT00563992|Drug|Lithium|Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
16311110|NCT00563992|Drug|Valproic acid|Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
16311111|NCT00563979|Dietary Supplement|VitaluxPlus®|1 tablet daily
16311112|NCT00563979|Dietary Supplement|Omega 3|1 tablet daily
16311113|NCT00563953|Drug|Liposomal pegylated doxorubicine|Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
16311114|NCT00563927|Procedure|Conventional RT|
16311115|NCT00563927|Drug|Cisplatin|
16311116|NCT00563927|Drug|5-fluorouracil|
16311117|NCT00563914|Drug|ferroquine (SSR97193)|associated with artesunate
16311118|NCT00563914|Drug|amodiaquine|associated with artesunate
16311119|NCT00563888|Behavioral|NET|Narrative Exposure Therapy for traumatized survivors of organized violence
16311120|NCT00563875|Drug|acetylsalicylic acid|75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.
16311121|NCT00563862|Procedure|Conventional RT|
16311122|NCT00563862|Procedure|Accelerated RT|
16311123|NCT00563862|Drug|Cisplatin|
16311124|NCT00563862|Drug|5-fluorouracil|
16311125|NCT00563849|Drug|Leflunomide|concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.
16311126|NCT00563836|Drug|Catumaxomab|10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
16311127|NCT00563823|Drug|vatalanib|
16311128|NCT00563810|Drug|MYO-029|
16311129|NCT00563797|Drug|Mecamylamine|mecamylamine 10mg/day for 12 weeks
16311130|NCT00563797|Drug|Placebo|Placebo pill
16311131|NCT00563784|Drug|Erlotinib|150 mg by mouth daily for 7 Weeks
16311132|NCT00563784|Drug|Carboplatin|2 AUC by vein weekly for 7 Weeks
16311133|NCT00563784|Drug|Paclitaxel|45 mg/m^2 by vein weekly for 7 Weeks
16311134|NCT00563784|Radiation|Radiation Therapy|63 GY/35 fractions for 7 weeks (+/- 5 days)
16311135|NCT00563771|Drug|Rasburicase|
16311136|NCT00563758|Drug|tegaserod|
16311137|NCT00563745|Device|telemedicine program|One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
16311138|NCT00563732|Drug|Lecozotan|
16311139|NCT00563706|Drug|vabicaserin|This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
16311140|NCT00563706|Drug|risperidone|
16311141|NCT00563706|Other|placebo|
16311142|NCT00563693|Device|ASV|Adaptive servo ventilator
16311143|NCT00563693|Other|without Autoset CS2|without Autoset CS2
16311144|NCT00563680|Drug|AMG 479|AMG 479 is a fully human monoclonal antibody (IgG1) against the insulin-like growth factor receptor-1 (IGF-1R). IGF-1R signaling has been shown to play a critical role in the survival of cancer cells. AMG 479 inhibits the binding of both IGF-1 and IGF-2 to IGF-1R, thus inhibiting ligand-dependent receptor activation. Inhibition of IGF-1R signaling with AMG 479 provides a potential mechanism for inhibiting tumor growth and survival.
16311145|NCT00563667|Procedure|pterygium excision|
16311146|NCT00563654|Drug|Alfuzosin GITS (Xatral XL)|
16311147|NCT00563641|Other|Very early surfactant and bubble NCPAP|For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O
16311148|NCT00563641|Other|bubble NCPAP|"Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach yes or no treatment failure criteria."
16311149|NCT00563628|Device|Panretinal photocoagulation with PASCAL system|Use the PASCAL laser system to deliver a retina photocoagulation
16311150|NCT00563615|Drug|Tegaserod|
16311151|NCT00563602|Other|Hemodynamic guided therapy|"To switch two or more different treatments for the prevention of variceal rebleeding according to the hemodynamic response. All patients in the experimental group will begin by:
~1) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)"
16311152|NCT00563589|Drug|mycophenolate mofetil, methotrexate, cyclosporin|
16311153|NCT00563589|Drug|Methotrexate and cyclosporin|
16311154|NCT00563576|Drug|Femring®|"Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use.
~Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 mm. Femring® 0.1 mg/day has a central core containing 24.8 mg of estradiol acetate which releases at a rate equivalent to 0.1 mg of estradiol per day for 3 months."
16311155|NCT00563576|Drug|DepoProvera ®|Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.
16311156|NCT00563563|Drug|NB32|All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
16311157|NCT00563563|Behavioral|Ancillary therapy|During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
16311158|NCT00563537|Radiation|18F-X PET SCAN|18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)
16311159|NCT00563524|Drug|ILV-094|SC and IV administration on days 1, 14, 28, and 42
16311160|NCT00563511|Procedure|adherence intervention|
16311161|NCT00563511|Procedure|intervention without adherence advice|
16311162|NCT00563511|Procedure|control|
16311163|NCT00563498|Drug|Glutamine|
16311164|NCT00563485|Drug|Doxazosin GITS (Cardura XL)|
16311165|NCT00563485|Drug|Terazosin (Hytrin)|
16311166|NCT00563472|Drug|estetrol|10 mg orally per day for 28 days
16311167|NCT00563472|Drug|estetrol|20 mg orally per day for 28 days
16311168|NCT00563472|Drug|estetrol and desogestrel|20 mg estetrol and 150 microg desogestrel orally per day for 28 days
16311169|NCT00563472|Drug|estetrol and progesterone|20 mg estetrol and 200 mg progesterone orally per day for 28 days
16311170|NCT00563459|Drug|carisbamate|400-1200 mg/day for 12 months
16311171|NCT00563459|Drug|topiramate|200-400mg/day for 12 months
16311172|NCT00563459|Drug|levetiracetam|1000-3000mg/day for 12 months
16311173|NCT00563446|Drug|Darbepoetin alfa|
16311174|NCT00563433|Drug|ofloxacin|400 mg twice a day for 14 days
16311175|NCT00563433|Drug|MSI-78|1%/2% topical cream twice a day for 14 days
16311176|NCT00563420|Procedure|Bronchoscopy|
16311177|NCT00563394|Drug|ofloxacin|400 mg twice a day for 14 days
16311178|NCT00563394|Drug|MSI-78|1%/2% topical cream twice a day for 14 days
16311179|NCT00563381|Drug|Tiotropium bromide|18 mcg/daily
16311180|NCT00563381|Drug|Salmeterol|100 mcg/daily
16311181|NCT00563381|Drug|Placebo Salmeterol|Placebo identical to Salmeterol device
16311182|NCT00563381|Drug|Placebo Tiotropium|Placebo identical to Tiotropium device
16311183|NCT00563368|Drug|VI-0521|phentermine 15 mg and topiramate 92 mg, po once daily
16311184|NCT00563368|Drug|VI-0521|phentermine 7.5 mg and topiramate 46 mg, po once daily
16311185|NCT00563368|Drug|topiramate|topiramate 46 mg, po once daily
16311186|NCT00563368|Drug|topiramate|topiramate 92 mg, po once daily
16311187|NCT00563368|Drug|phentermine|phentermine 7.5 mg, po once daily
16311188|NCT00563368|Drug|phentermine|phentermine 15 mg, po once daily
16311189|NCT00563368|Drug|VI-0521|placebo, po once daily
16311190|NCT00563355|Drug|erythropoietin|
16311191|NCT00563342|Drug|Ethanol|Examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis
16311192|NCT00563329|Procedure|Reduction Intervention + Adherence Intervention|
16311193|NCT00563329|Behavioral|Reduction Intervention|
16311194|NCT00563329|Procedure|control|
16311195|NCT00563316|Drug|Panitumumab|The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
16311196|NCT00563316|Drug|Irinotecan|The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
16311197|NCT00563303|Drug|hydrocortisone|200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
16311198|NCT00563303|Drug|NaCl|48mL from Day 1 to Day 6
16311199|NCT00563290|Drug|dasatinib|Given PO
16311200|NCT00563290|Other|laboratory biomarker analysis|Correlative studies
16311201|NCT00563277|Procedure|combined pterygium and cataract operation|
16311202|NCT00563277|Procedure|pterygium excision followed by cataract operation|
16311203|NCT00563264|Behavioral|KAN-DO|"The 10 month KAN-DO intervention includes eight mailed interactive activity modules involving both the preschooler and mother that include relevant printed materials emphasizing parenting skills, healthy eating habits and increased physical activity. Mailed kits will each be followed by a supportive telephone counseling session based on motivational interviewing techniques. Mailed modules and telephone calls will be supplemented with two in-person motivational and informational sessions (at the beginning and in the middle of the intervention period).
~The Active Comparator group will receive monthly newsletters over the 10 month period related to boosting reading skills in their preschool children."
16311204|NCT00563251|Drug|Azithromycin|
16311205|NCT00563251|Drug|Placebo tablet|
16311206|NCT00563238|Drug|Metoprolol|Metoprolol administered intravenously in 2.5mg boluses until the resting heart rate falls by 10% from baseline to a maximum dose of 10mg, or until there is any apparent adverse reaction.
16311207|NCT00563225|Drug|Insulin Glargine|Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
16311208|NCT00563212|Drug|aerosol interferon-gamma|aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year
16311209|NCT00563199|Behavioral|nurse-delivered stage-matched smoking cessation counseling|
16311210|NCT00563186|Other|Admission to a novel hospital ward|Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains)
16311211|NCT00563173|Drug|CHRONVAC-C®|DNA vaccine, solution for injection, i.m. administration in combination with electroporation
16311212|NCT00563160|Drug|gemcitabine, carboplatin|
16311213|NCT00563160|Procedure|surgery|
16311214|NCT00563147|Drug|tivozanib (AV-951) plus temsirolimus|ascending doses of tivozanib (AV-951) capsules administered orally for 21 days with discontinuation for 7 days; ascending doses of temsirolimus administered intravenously every 7 days
16311215|NCT00563134|Drug|GR270774|
16311216|NCT00563121|Procedure|Vitrectomy|Open-Sky vitrectomy, with resection of the tunica vasculosa lentis, and retinal reattachment
16311217|NCT00563108|Drug|Basiliximab|
16311218|NCT00563108|Drug|Placebo|
16311219|NCT00563095|Procedure|Transcatheter Arterial Chemoembolization (TACE)|
16311220|NCT00563095|Procedure|Transcatheter Arterial Pegylated Interferon Embolization (TAIE)|
16311221|NCT00563069|Drug|Midazolam|
16311222|NCT00563056|Drug|Flutiform|
16311223|NCT00563056|Drug|Flixotide plus Foradil|
16311224|NCT00563043|Procedure|PASCAL laser treatment|Patterns Scan Laser treatment in patients with PDR.
16311225|NCT00563017|Drug|Long-acting Risperidone microspheres injection|
16311226|NCT00563004|Dietary Supplement|DBCARE|Patients receive dbcare 2 tablets TID for 3 months
16311227|NCT00563004|Dietary Supplement|DBCARE|PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
16311228|NCT00562991|Device|measurement of exhaled NO is used to guide treatment|exhaled NO
16311229|NCT00562978|Biological|filgrastim|
16311230|NCT00562978|Drug|cyclophosphamide|
16311231|NCT00562978|Drug|etoposide|
16311232|NCT00562978|Procedure|AHSCT|
16311233|NCT00562978|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16311234|NCT00562965|Drug|inotuzumab ozogamicin|IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
16311235|NCT00562965|Drug|rituximab|IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
16311236|NCT00562965|Drug|rituximab|intravenous rituximab at a dose of 375 mg/m2 on day 1
16311237|NCT00562965|Drug|cyclophosphamide|intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
16311238|NCT00562965|Drug|vincristine|intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
16311239|NCT00562965|Drug|prednisone/prednisolone|oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
16311240|NCT00562965|Drug|mitoxantrone|mitoxantrone 10 mg/m2 intravenous on day 2
16311241|NCT00562965|Drug|fludarabine|fludarabine 25 mg/m2 intravenous on days 2 through 4
16311242|NCT00562965|Drug|dexamethasone|oral dexamethasone 20 mg/day on days 1-5
16311243|NCT00562952|Drug|Telmisartan, Bisoprolol|Dosage will be given dependent on the NT-pro-BNP levels. Up-titration will be performed until values are decreased to 50% or below normal cut-point
16311244|NCT00562952|Drug|placebo|no intervention
16311245|NCT00562939|Biological|Pneumococcal vaccines + CPG 7909|Day 0: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 90: 1 ml Prevenar (double dose) + 1 mg CpG 7909, IM Day 270: 0.5 ml Pneumo Novum + 1 mg CpG 7909, IM
16311246|NCT00562939|Biological|Pneumococcal vaccines|Day 0: 1 ml Prevenar (double dose) + placebo, IM Day 90: 1 ml Prevenar (double dose) + placebo, IM Day 270: 0.5 ml Pneumo Novum + placebo, IM
16311247|NCT00562926|Procedure|Extraction of 10ml blood sample for extraction of genomic DNA using DNA purification kits|
16311248|NCT00562913|Drug|Nexavar (Sorafenib, BAY43-9006)|Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin
16311249|NCT00562900|Procedure|robotic assisted cholecystectomy|robotic assisted cholecystectomy
16311250|NCT00562900|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy
16311251|NCT00562887|Biological|Placebo|every 4 weeks, IV
16311252|NCT00562887|Biological|ABT-874|400 mg IV every 4 weeks
16311253|NCT00562887|Biological|ABT-874|700 mg IV every 4 weeks
16311254|NCT00562874|Dietary Supplement|Meat Biscuit|75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
16311255|NCT00562874|Dietary Supplement|Soy Biscuit|75 women and one of their children will receive a biscuit containing soy four as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day.
16311256|NCT00562874|Dietary Supplement|Wheat Biscuit|75 women and one of their children will receive a biscuit containing only wheat lour as a source of protein as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 8 grams of protein per day and children will receive 350 calories and 5 grams of protein per day.
16311257|NCT00562861|Drug|citalopram + mood stabilizer|Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.
16311258|NCT00562861|Drug|placebo + mood stabilizer|This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.
16311259|NCT00562848|Drug|GSK962040|GSK962040 will be supplied in the following tablet strengths: 1 milligram, 5m milligrams, 25 milligrams, 125 milligrams.
16311260|NCT00562848|Drug|Placebo|Subjects will receive placebo.
16311261|NCT00562835|Drug|Methylprednisolone|"Drug: Methylprednisolone Day 0 Loading dose 1 mg/kg IV bolus (30 min) followed by continuous infusion; Days 0 to 14*† ‡ 1 mg/kg/day mixed in 240cc Normal saline (NS) and infused at 10 cc/hr; Days 15 to 21*‡ 0.5 mg/kg/day mixed in 240cc NS and infused at 10 cc/hr; Days 22 to 25*‡ 0.25 mg/kg/day; Days 26 to 28*‡ 0.125 mg/kg/day
~*Five days after the patient is able to ingest medications, methylprednisolone is given per os in one single daily equivalent dose.
~†If between days 1 to 14 the patient is extubated, he is advanced to day 15 of drug therapy and tapered according to schedule.
~‡ When leaving ICU, if the patient is still not tolerating p.o. intake for at least five days, he should receive the specified dosage as IV push every 6 hours until tolerating oral ingestion"
16311262|NCT00562835|Other|Normal saline intravenously and vitamin B1 per os|Patients in this group will receive sterile normal saline in an amount that would equal the total diluted dose of study drug (ie. if initial loading dose equals a total of 25 cc [prednisolone + diluting fluid], then the patient will receive 25 cc of sterile normal saline). Tapering doses will be equivalent to that of the study arm. Five days after the patient is able to ingest medications, placebo is administered per os in one single daily equivalent dose. The placebo will be a Vitamin B1 (thiamine) 50-mg tablet. We will now designate each placebo tab as a 16-mg equivalent to each tablet of active drug. These tablets are scored and half tabs can be given if needed. Therefore if a patient is receiving 40 mg of study drug: 40/16 = 2.5 tabs x 50 mg = 125 mg actual dose of thiamine.
16311263|NCT00562822|Procedure|Arthroscopic surgery|Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
16311264|NCT00562822|Other|Physical and medical therapy|Treatment with physical and medical therapy alone
16311265|NCT00562809|Drug|IRBESARTAN|150/12.5 mg tablets one or two tablets orally per day
16311266|NCT00562783|Drug|Vitaliver|
16311267|NCT00562783|Drug|Placebo|
16311268|NCT00562770|Drug|Valganciclovir|900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
16311269|NCT00562770|Drug|Valacyclovir|500 mg po QD during therapy and for 2 months post alemtuzumab initiation.
16311270|NCT00562744|Other|Simulation|Use of high-fidelity patient simulator for training and assessment of PALS scenario performance
16311271|NCT00562731|Drug|ARD-0403|Daily transdermal ARD-0403
16311272|NCT00562718|Drug|capecitabine|
16311273|NCT00562718|Procedure|adjuvant therapy|
16311274|NCT00562718|Radiation|radiation therapy|
16311275|NCT00562705|Behavioral|growth hormone- Genotropin or NorditropinSimplex and nutritional intervention|"A combined treatment of growth hormone (Genotropin or NorditropinSimplex or Biotropin) and nutritional intervention"
16311276|NCT00562705|Behavioral|"growth hormone-Genotropin or NorditropinSimplex or Biotropin"|"Growth hormone treatment (Genotropin, or NorditropinSimplex or Biotropin)."
16311277|NCT00562692|Drug|Nesiritide|Nesiritide 4 hour infusion
16311278|NCT00562692|Drug|Placebo|Placebo infusion
16311279|NCT00562679|Other|There is no intervention|
16311280|NCT00562666|Other|T gamma delta lymphocytes|Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
16311372|NCT00562094|Drug|Pantoprazole|This was an observational study. Therefore, the physician decided about dosage according to individual needs.
16311281|NCT00562640|Biological|filgrastim|Stem cell mobilization and harvest: Patients receive filgrastim (G-CSF) subcutaneously daily for five days. PBMC are collected by leukapheresis on the fifth day and then cryopreserved for subsequent reinfusion into the patient, in the event of prolonged cytopenia.
16311282|NCT00562640|Biological|therapeutic autologous lymphocytes|Autologous T-cell infusion with or without conditioning chemotherapy ( fludarabine treatment closed as of 12/01/2009): Approximately 4-6 weeks after T-cell sensitization, patients receive an infusion of autologous WT1-specific T cells over 5-10 minutes on day 0. Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2 and fludarabine phosphate IV over approximately 30 minutes on days -6 to -2. After a 48-hour rest period, patients receive autologous WT1-specific T cells. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after completion of therapy, may receive additional courses of autologous WT1-specific T cells every 14 days.
16311283|NCT00562640|Drug|cyclophosphamide|Patients enrolled in dose levels II and III also undergo pre-infusion lymphodepletive conditioning comprising cyclophosphamide IV on day -2
16311284|NCT00562640|Other|laboratory biomarker analysis|Obtained prior to adoptive therapy to quantitate baseline levels of WT1 reactive T cells, by quantitation of WT1 specific CTLp by LDA, T cells secreting IFNγ in response to peptide and, in HLA A0201+ patients, T cell binding WT1 peptide HLA A2 tetramers.
16311285|NCT00562627|Drug|ropivacaine|intraoperative and 1. postoperative day
16311286|NCT00562627|Drug|adrenaline|intraoperative LIA (IV and IA) and continuous EDA
16311287|NCT00562627|Drug|ketorolac|intraoperative and 1. postoperative day
16311288|NCT00562627|Drug|morphine|intraoperative
16311289|NCT00562627|Drug|fentanyl|continuous postoperatively
16311290|NCT00562627|Drug|bupivacaine|continuous postoperatively
16311291|NCT00562614|Drug|SLx-2101|
16311292|NCT00562588|Drug|Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)|
16311293|NCT00562588|Drug|ASA 100 mg qd|
16311294|NCT00562575|Drug|SLx-4090|
16311295|NCT00562575|Drug|Placebo|
16311296|NCT00562562|Other|osteopathic manipulative treatment|Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.
16311297|NCT00562549|Drug|SLx-2101|
16311298|NCT00562536|Procedure|Umbilical cord clamping|Delay of umbilical cord clamping 30 to 45 seconds
16311299|NCT00562523|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks
16311300|NCT00562510|Drug|Raltegravir|Raltegravir 400 mg BID added to stable HAART
16311301|NCT00562510|Drug|Placebo|Placebo BID added to stable HAART
16311302|NCT00562497|Drug|Prochymal|Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the active treatment group will receive Prochymal™ at 2 x 106 human mesenchymal stem cells (hMSC)/kg per infusion.
16311303|NCT00562497|Other|Placebo|Subjects will be treated with a total of 6 infusions of investigational agent during the first 4 weeks of the study. Four infusions will be administered during the first two weeks (twice weekly), then two infusions administered during the next two weeks (once weekly). Subjects assigned to the non active treatment group will receive placebo (excipient, less cells). It is recommended that all subjects receive all six infusions. The discontinuation of investigational agent is allowed for GVHD worsening with subsequent need for salvage therapy. All infusions must be given at least 3 days apart.
16311304|NCT00562484|Biological|CSL Limited Influenza Vaccine|A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
16311305|NCT00562484|Biological|Placebo|Placebo
16311306|NCT00562471|Other|Adhibit Adhesion Prevention Gel|A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.
16311307|NCT00562471|Other|Standard of Care Comparator|standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure
16311308|NCT00562458|Drug|anastrozole|
16311309|NCT00562432|Device|Plexisyl-AF|Plexisyl-AF implants
16311310|NCT00562432|Other|No Treatment|CABG without the experimental treatment
16311311|NCT00562419|Drug|CT-322|IV solution, weekly
16311312|NCT00562419|Drug|irinotecan hydrochloride|IV solution, biweekly
16311313|NCT00562406|Drug|Ranibizumab|intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
16311314|NCT00562406|Procedure|Laser photocoagulation|laser photocoagulation to the retina at the area of edema
16311315|NCT00562393|Other|Nutritional|Overfeeding high fat diet for 28 days
16311316|NCT00562380|Biological|ganitumab|
16311317|NCT00562380|Other|laboratory biomarker analysis|
16311318|NCT00562380|Other|pharmacological study|
16311319|NCT00562380|Procedure|biopsy|
16311320|NCT00562367|Drug|Cytomel (liothyronine)|Cytomel (liothyronine) 25-50 mcg/day for 4 weeks
16311321|NCT00562354|Biological|13vPnC|13vPnC for both stratum
16311322|NCT00562341|Other|Bariatric Surgery|one time lapb-band gastric bypass surgery
16311323|NCT00562328|Biological|Alemtuzumab|"Week 1 (dose escalation):
~Day 3: 3mg subcutaneously; Day 4: 10mg subcutaneously; Day 5 30mg subcutaneously
~Weeks 2-5:
~30mg subcutaneously three times a week."
16311324|NCT00562328|Biological|Rituximab|"Weeks 2-5:
~375 mg/m^2 by IV once weekly"
16311325|NCT00562328|Biological|Sargramostim|"Week 1-6:
~250 mcg subcutaneously three time as week"
16311326|NCT00562315|Drug|FACBC|Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
16311327|NCT00562315|Other|ProstaScinct|ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
16311328|NCT00562302|Device|Bio-Seal Plug|Deployment of the Bio-Seal plug in needle track
16311329|NCT00562289|Drug|aspirin|during the follow up
16311330|NCT00562289|Drug|Antivitamins K or rivaroxaban or dabigatran or apixaban|during the follow up
16311331|NCT00562289|Device|Devices for PFO closure|endovascular treatment no longer than 21 days after the random.
16311332|NCT00562276|Procedure|Immediate IUD insertion|Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
16311333|NCT00562263|Behavioral|Lifestyle modification|Dietary modification and regular physical activity
16311334|NCT00562250|Drug|Dapagliflozin|Tablets, Oral, 20 mg, once daily, single dose
16311335|NCT00562250|Drug|Glimepiride|Tablets, Oral, 4 mg, once daily, single dose
16311336|NCT00562250|Drug|Dapagliflozin + Glimepiride|Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
16311337|NCT00562237|Biological|S205 placebo|2 i.m. injections per subject (0.5 mL each)
16311338|NCT00562237|Biological|S205 10ugHA|2 i.m. injections per subject (0.5 mL each)
16311339|NCT00562237|Biological|S205 30ugHA|2 i.m. injections per subject (0.5 mL each)
16311340|NCT00562237|Biological|S205 10ugHA+500ugAlOH|2 i.m. injections per subject (0.5 mL each)
16311341|NCT00562237|Biological|S205 30ugHA+500ugAlOH|2 i.m. injections per subject (0.5 mL each)
16311342|NCT00562237|Biological|S205 10ugHA+1250ugAlOH|2 i.m. injections per subject (0.5 mL each)
16311343|NCT00562237|Biological|S205 30ugHA+1250ugAlOH|2 i.m. injections per subject (0.5 mL each)
16311344|NCT00562224|Drug|PCI-24781|"Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart (TID), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart (BID). If a DLT occurs on the BID schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached."
16311345|NCT00562211|Drug|LidoDyn|Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
16311346|NCT00562211|Drug|EMLA creme|Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
16311347|NCT00562198|Drug|entacapone and carbidopa|Entacapone 200mg carbidopa 50mg
16311348|NCT00562198|Drug|Sinemet 200mg/50mg|Sinemet 200mg/50mg once
16311349|NCT00562185|Drug|carboplatin|
16311350|NCT00562185|Drug|doxorubicin hydrochloride|
16311351|NCT00562172|Drug|Insulin glargine|Once daily in the morning
16311352|NCT00562172|Drug|Glimepiride|Once daily in the morning
16311353|NCT00562172|Drug|Metformin|At least 1000 mg/day
16311354|NCT00562159|Drug|Placebo|Placebo sublingual tablet
16311355|NCT00562159|Biological|SCH 697243|SCH 697243 (2800 Bioequivalent Allergen Units [BAU] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.
16311356|NCT00562159|Drug|Loratadine 10 mg Rescue Treatment|Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.
16311357|NCT00562159|Drug|Olopatadine 0.1% Rescue Treatment|Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for rhinoconjunctivitis, as needed.
16311358|NCT00562159|Drug|Mometasone 50 mcg Rescue Treatment|Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis, as needed.
16311359|NCT00562159|Drug|Prednisone 5 mg Rescue Treatment|"Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day
~(maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for rhinoconjunctivitis among participants with a total symptom score of ≥ 4 despite treatment with loratadine and mometasone furoate nasal spray."
16311360|NCT00562159|Drug|Albuterol sulfate 108 mcg|Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administed via inhalation at a dose of 2 inhalations every 4 to 6 hours, as needed, as rescue medication for asthma.
16311361|NCT00562159|Drug|Fluticasone propionate 44 mcg|Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice daily, as rescue medication for asthma among participants utilizing four or more albuterol sulfate inhalations/day for 2 days for nocturnal asthma or shortness of breath.
16311362|NCT00562159|Drug|Prednisone 5 mg|Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for asthma at the discretion of the investigator for the treatment of asthma exacerbation.
16311363|NCT00562146|Procedure|placement of spiral nasojejunal tube|spiral nasojejunal tube will be placed after enrollment of the patients
16311364|NCT00562133|Drug|Insulin Glulisine|100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
16311365|NCT00562133|Drug|Insulin|100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
16311366|NCT00562120|Drug|Placebo|A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.
16311367|NCT00562120|Drug|Allegra|A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
16311368|NCT00562120|Drug|Allegra-D|A single oral dose of Allegra-D is dosed to subjects as an active comparator.
16311369|NCT00562120|Drug|PF-03654746|A single oral dose of PF-03654746 is the investigational drug being studied.
16311370|NCT00562107|Device|Symphony DR 2550 and REPLY DR cardiac pacemakers|AAISafeR/SafeR ON
16311371|NCT00562107|Device|Symphony DR 2550 and REPLY DR cardiac pacemakers|DDD(R) (SafeR OFF)
16311373|NCT00562081|Behavioral|Education|24/7 access to a Certified Asthma Educator
16311374|NCT00562081|Behavioral|Education|Patient does not have 24/7 access to a Certified Asthma Educator.
16311375|NCT00562068|Biological|alemtuzumab|
16311376|NCT00562068|Drug|cyclophosphamide|
16311377|NCT00562068|Drug|doxorubicin hydrochloride|
16311378|NCT00562068|Drug|prednisolone|
16311379|NCT00562068|Drug|vincristine sulfate|
16311380|NCT00562068|Genetic|polymerase chain reaction|
16311381|NCT00562068|Other|flow cytometry|
16311382|NCT00562068|Other|laboratory biomarker analysis|
16311383|NCT00562068|Other|pharmacological study|
16311384|NCT00562055|Drug|Atomoxetine|
16311385|NCT00562055|Drug|PNU-165442G; [S,S]-reboxetine|
16311386|NCT00562029|Procedure|Duodenal-jejunal Bypass|Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
16311387|NCT00562016|Device|IMPLELLA LP 2.5|Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.
16311388|NCT00562016|Device|IABP Intra-aortic balloon pump|IABP uses counterpulsation to provide 0.2L/min coronary flow
16311389|NCT00562003|Procedure|Tenckhoff Catheter placement|'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.
16311390|NCT00562003|Drug|Ad5-delta24RGD|"Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed.
~The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'."
16311391|NCT00561990|Drug|Nimotuzumab|
16311392|NCT00561977|Behavioral|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
16311393|NCT00561977|Behavioral|low saturated fat diet|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.
16311394|NCT00561977|Behavioral|Combination diet|combination low saturated fat high fiber diet, with calorie restriction as specified.
16311395|NCT00561964|Drug|Irbesartan|Irbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end)
16311396|NCT00561964|Drug|placebo|Placebo group: 2 placebo capsules daily as a single morning intake
16311397|NCT00561951|Drug|fesoterodine fumarate|8mg tablets OD for 12 weeks
16311398|NCT00561951|Drug|Placebo|Corresponding placebo tablets OD for 12 weeks
16311399|NCT00561951|Drug|fesoterodine fumarate|4mg tablets OD for 12 weeks
16311400|NCT00561938|Procedure|Colonoscopy|microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist. General tolerance and potential late adverse events will be assessed by the careful inquiry performed 1 month after the procedure by consultant gastroenterologist.
16311401|NCT00561938|Procedure|Endoscopy|After obtaining a written informed consent from all the patients, standard upper GI endoscopy or colonoscopy will be performed under general anaesthesia using a videoendoscope EC-3870 (Pentax), which includes a miniaturized microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist.
16311402|NCT00561925|Drug|nevirapine IR|200 mg BID
16311403|NCT00561925|Drug|nevirapine XR|400 mg QD
16311404|NCT00561912|Drug|Decitabine|15 mg/m^2 IV Daily over one hour for 5 days
16311405|NCT00561912|Drug|Interferon Alfa-2b|0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.
16311406|NCT00561899|Drug|SP, amodiaquine, piperaquine, dihdroartemisinin|once every month during september, October and November
16311407|NCT00561899|Drug|intermittent preventive treatment|SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Du-Cotecxin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days
16311408|NCT00561899|Drug|Du-Cotecxin|Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days
16311409|NCT00561886|Drug|Formoterol|One inhalation of 24µg Formoterol
16311410|NCT00561860|Device|Telemedicine Arm|Telemedicine involves the provision or support of direct clinical care via the application of electronic and communicating technology, including the remote monitoring of health status. By providing patient data early in the course of CPAP prescription, we believe that this technology would be immensely useful in improving compliance and acceptance of the device in patients with sleep apnea.
16311411|NCT00561834|Drug|ranibizumab|All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.
16311412|NCT00561821|Drug|Esmirtazapine|one tablet daily
16311413|NCT00561821|Drug|Placebo|one tablet daily
16311459|NCT00561418|Drug|vorinostat|Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
16311414|NCT00561808|Other|In-vitro maturation oocytes|Immature oocytes (development stage GV or M1) will be matured in-vitro in IVM culture medium for approximately 28-32 hours. The oocytes will be routinely observed and when they reach maturation (M2) they will be fertilized. The developed embryo will be transferred to the patient 24 hours post-fertilization.
16311415|NCT00561795|Drug|pazopanib (GW786034)|800 mg orally once a day for 6 cycles
16311416|NCT00561795|Drug|carboplatin|IV over one hour every 3 weeks of 6 cycles
16311417|NCT00561795|Drug|paclitaxel|IV 175 mg/m^2 given over 3 hours on day one of a 21 day cycle for six cycles
16311418|NCT00561769|Drug|Norditropin pen|12 IU per day
16311419|NCT00561756|Biological|plasmid DNA vaccine therapy|
16311420|NCT00561756|Other|flow cytometry|
16311421|NCT00561756|Other|immunoenzyme technique|
16311422|NCT00561743|Drug|Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone|
16311423|NCT00561730|Drug|Pantoprazole|Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
16311424|NCT00561717|Drug|Azelastine and placebo|One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
16311425|NCT00561717|Drug|Loratadine and Placebo|One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
16311426|NCT00561717|Drug|Cetirizine and Placebo|One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
16311427|NCT00561717|Drug|Placebo and Placebo (spray and Tablet)|One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
16311428|NCT00561704|Drug|losartan|losartan, 100mg daily,
16311429|NCT00561691|Drug|nimotuzumab|monoclonal antibody
16311430|NCT00561678|Drug|Precedex (Dexmedetomidine)|0.5/ug/kg/hr Dexmedetomidine infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.
16311431|NCT00561678|Drug|Placebo|0.5/ug/kg/hr Placebo infusions will begin prior to the surgery (no loading dose), and will be maintained at 0.5 mcg/kg/hour throughout surgery and titrated postoperatively for 2 hours postoperatively.
16311432|NCT00561652|Behavioral|Education & Exercise|Education & Exercise
16311433|NCT00561652|Procedure|Chiropractic treatment (plus Education & Exercise)|Chiropractic treatment (plus Education & Exercise)
16311434|NCT00561626|Dietary Supplement|high fat diet followed by low fat diet|High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
16311435|NCT00561626|Dietary Supplement|low fat diet followed by high fat diet|Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
16311436|NCT00561613|Other|SILCS and lubricant|
16311437|NCT00561613|Other|SILCS and spermicide|
16311438|NCT00561600|Device|ASR™-XL Modular Acetabular Cup System|The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
16311439|NCT00561600|Device|Pinnacle™ acetabular shell|The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
16311440|NCT00561587|Drug|Seroquel®|dosage form: oral, adjusted in the range of 25 to max. 300 mg /day
16311441|NCT00561574|Drug|Esmirtazapine|One tablet daily
16311442|NCT00561561|Behavioral|Acoustic startle testing|recording of eyeblink component of acoustic startle reflex with small surface electrodes during presentation of acoustic stimuli through headphones
16311443|NCT00561548|Procedure|rectosigmoïdal biopsies|rectosigmoïdal biopsies
16311444|NCT00561535|Dietary Supplement|Lactobacillus FARCIMINIS|10.10 UFC of lactobacillus FARCIMINIS
16311445|NCT00561535|Dietary Supplement|placebo (starch)|Once daily
16311446|NCT00561522|Drug|Capecitabine|Capecitabine 1,250 mg/m2 twice daily on days 1-14, followed by a 7-day drug-free interval. Treatment repeats every 21 days. The above cycle is repeated for 4-6 times.If disease recurrence or unacceptable toxicity or other criteria for withdrawal are met, treatment will be stopped.
16311447|NCT00561522|Other|No other preventive treatment|No other preventive treatment
16311448|NCT00561509|Drug|SSRIs|Use within normal clinical practice
16311449|NCT00561509|Drug|Dual antidepressants|Use within clinical practice
16311450|NCT00561496|Drug|Tenofovir gel|Intravaginal (4grams)single dose followed by fourteen days
16311451|NCT00561470|Drug|Placebo|4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks
16311452|NCT00561470|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
16311453|NCT00561470|Drug|FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)|"The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1
~The FOLFIRI regimen included:
~180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
~5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
~5-FU 2400 mg/m² continuous IV infusion over 46-hours"
16311454|NCT00561470|Drug|FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)|"The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1
~The FOLFIRI regimen included:
~180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
~5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
~5-FU 2400 mg/m² continuous IV infusion over 46-hours"
16311455|NCT00561457|Device|Bard Luminexx Iliac Stent and Delivery System|Iliac Stenting
16311456|NCT00561444|Behavioral|Questionnaire|Questionnaires taking 20 minutes to complete.
16311457|NCT00561431|Device|Standard dose of dialysis|Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
16311458|NCT00561431|Device|High dose of dialysis|Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr
16311460|NCT00561418|Other|Correlative studies|Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)
16311461|NCT00561405|Behavioral|Motor Learning Walking Program|Motor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner. Sessions 45 minutes, 3x per week over 5 weeks for a total of 15 sessions
16311462|NCT00561405|Behavioral|Body Weight Supported Treadmill Training|Participants practice walking on a treadmill while supported with an overhead harness system. Up to 40% body weight support. Target Treadmill speed 2.0 mph. 1 or 2 Trainers (at least one Physical Therapist plus another Physical Therapist or Physiotherapy Assistant) will help guide participants leg, foot and trunk during treatment. Aim is to practice high numbers of repetition of the normal gait cycle on treadmill. Duration of sessions - 20 minutes of treadmill training within a 45 minute session ( 4 sets of 5 minutes of training with 5 minute rests). 3 sessions per week for 5 weeks. Total of 15 sessions.
16311463|NCT00561392|Drug|Rivastigmine 5 and 10 cm^2 patch|
16311464|NCT00561379|Drug|CHOP+RITUXIMAB|CHOP-14- Rituximab x 8 courses
16311465|NCT00561379|Drug|CEEP-RITUXIMAB|High dose chemotherapy with rituximab including autologous stem cell support.
16311466|NCT00561366|Drug|Placebo|Placebo t.i.d.
16311467|NCT00561366|Drug|Arimoclomol|capsule, 400 mg t.i.d.
16311468|NCT00561353|Drug|TMC435|TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.
16311469|NCT00561353|Drug|Placebo|Placebo capsules identical in appearance to TMC435 capsules taken orally (by mouth) once daily for 28 days.
16311470|NCT00561353|Drug|Peginterferon (PegIFNα-2a)|One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFNα-2a on Days 1, 8, 15, and 22
16311471|NCT00561353|Drug|Ribavirin|200-mg tablets of ribavirin (body-weight adjusted dose) taken orally (by mouth) twice daily for 21 or 28 days in Cohorts 1 and 2 and for 28 days in Cohorts 4 and 5.
16311472|NCT00561340|Dietary Supplement|Pediasure|50% will be randomized to pediasure with nutritional counseling
16311473|NCT00561340|Behavioral|Nutritional counseling|50% randomized to nutritional counseling only
16311474|NCT00561327|Drug|losartan|Daily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention)
16311475|NCT00561314|Other|questionnaire administration|
16311476|NCT00561314|Procedure|biopsy|
16311477|NCT00561314|Procedure|high-intensity focused ultrasound ablation|
16311478|NCT00561314|Procedure|magnetic resonance imaging|
16311479|NCT00561314|Procedure|quality-of-life assessment|
16311480|NCT00561301|Drug|GemDOx|gemcitabine oxliplatin
16311481|NCT00561288|Drug|acetaminophen|2 x 1000 mg doses per day
16311482|NCT00561288|Other|cornstarch|2 x 1000 mg cornstarch per day
16311483|NCT00561275|Biological|LY6K, VEGFR1, VEGFR2|1 mg/body every two week with GM-CSF, 4 cycles
16311484|NCT00561262|Other|questionnaire administration|
16311485|NCT00561262|Procedure|high-intensity focused ultrasound ablation|
16311486|NCT00561262|Procedure|quality-of-life assessment|
16311487|NCT00561249|Procedure|laser assisted hatching|Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo
16311488|NCT00561223|Drug|iloprost Inhalation|inhale 2.5 mg, repeat times one
16311489|NCT00561223|Drug|iloprost|inhaled 2.5 mg, repeat times one
16311490|NCT00561210|Dietary Supplement|Crucial|Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
16311491|NCT00561210|Dietary Supplement|Sondalis HP|Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
16311492|NCT00561197|Drug|AT-101|Patients will receive AT-101 starting at 10 mg once daily for 5 of 7 days in conjunction with RT (50.4 Gy for 28 fractions) for approximately 5.5 weeks. Concurrently, patients will receive docetaxel (20 mg/m2) IV weekly (Monday) and 5-fluorouracil (300 mg/m2) as a 24 hour continuous infusion for 5 of 7 days (Monday-Friday) of each RT week for approximately 5 weeks. Patients will continue for full 5.5 weeks unless unacceptable toxicity occurs.
16311493|NCT00561184|Biological|H5N1 influenza vaccine|One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
16311494|NCT00561184|Biological|H5N1 influenza vaccine|One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen
16311495|NCT00561171|Drug|SPP635|oral once daily
16311496|NCT00561158|Behavioral|Eat Well Live Well Nutrition Program|"12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information.
~The group sessions included are:
~Rate Your Plate: determining high fat foods
~Label Reading: reading food labels
~Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income
~Recipe Modification: preparing old recipes in new ways to reduce fat
~Eating Out: order healthier fast foods
~Coping with High Risk Situations: coping with situations in which these new habits may be threatened
~Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including:
~Substituting fat-modified foods for high fat foods
~Avoiding fat as a seasoning or flavoring
~Avoiding fried foods
~Modifying meat
~Replacing high fat foods with fruits, vegetables, grains and breads"
16311497|NCT00561145|Other|Energy restriction period|The experiment can be divided in 3 phases, namely (1) run-in phase, (2) energy restriction phase and (3) ad libitum food intake phase. Thus, for all participants the experiment consists of three subsequent phases.
16311498|NCT00561132|Dietary Supplement|Vanadyl sulfate|50 mg twice daily orally for a period of 4 weeks
16311499|NCT00561132|Other|Magnesium oxide|Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks
16311500|NCT00561119|Drug|gemcitabine , paclitaxel|"Gemcitabine 1250 mg/m2 i.v. Day 1 & 8
~Paclitaxel 175 mg/m2 i.v. day 1
~repeat every 3 weeks"
16311537|NCT00560859|Other|Watchful Waiting|Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
16311501|NCT00561106|Drug|prednisone- valacyclovir|prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.
16311502|NCT00561106|Drug|prednisone-placebo|prednisone, a dose of 1 mg/kg body weight was given daily for 7 days
16311503|NCT00561093|Drug|pentoxiphylline|pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311504|NCT00561093|Dietary Supplement|Nepro|Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311505|NCT00561093|Dietary Supplement|anti-inflammatory module (similar to Oxepa)|Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311506|NCT00561093|Drug|Placebo pill imitating pentoxiphylline|Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311507|NCT00561093|Dietary Supplement|Placebo to imitate Nepro|Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311508|NCT00561093|Dietary Supplement|Placebo to imitate anti-inflammatory module (similar to Oxepa)|Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
16311509|NCT00561080|Biological|Zostavax|
16311510|NCT00561067|Drug|Erythropoietin|EPO 500 IU/kg diluted in 50 ml saline and infused in 30 minutes; treatment is started within eight hours after the spinal injury; the same drug dosage will be infused at 24 and 48 hours
16311511|NCT00561067|Drug|Methylprednisolone|MP 30 mg/kg intravenous (iv) in the first hour, followed by 5.4 mg/kg/h for 23 hours if treatment is started within three hours after the spinal injury,or for 48 hours if treatment is started between three and eight hours (protocol NASCIS III, National Acute Spinal Cord Injury Study)
16311512|NCT00561054|Drug|CETUXIMAB|400 mg/m2 starting dose, 250 mg/m2 weekly dose
16311513|NCT00561041|Behavioral|Brief phone aftercare intervention|Interventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule
16311514|NCT00561041|Behavioral|individual aftercare therapy|composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule
16311515|NCT00561028|Other|blood sample analysis - mycoplasma and chlamydia antibodies|Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
16311516|NCT00561015|Drug|Telaprevir|Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
16311517|NCT00561015|Drug|Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)|Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
16311518|NCT00561015|Drug|Placebo|Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
16311519|NCT00561002|Biological|2007-2008 Influenza Virus Vaccine|0.25 mL, Intramuscular
16311520|NCT00561002|Biological|2007-2008 Influenza Virus Vaccine|0.25 mL, Intramuscular
16311521|NCT00560976|Drug|Iron Saccharate (Venofer)|Hemodialysis with IV iron administration of 100 mg Iron Saccharate (Venofer) in 150 ml 0.9 % saline to the arterial dialysis line during first hour of mid-week dialysis session. An alternative IV iron brand in some centers participating in the study could bebe 62.5 mg ferric gluconate (Ferrlecit).
16311522|NCT00560963|Drug|everolimus|
16311523|NCT00560950|Biological|pneumococcal 23v polysaccharide vaccine|Duration of Treatment: Single vaccination on Day 1
16311524|NCT00560937|Drug|Pregnenolone|Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks
16311525|NCT00560937|Drug|Placebo|Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks
16311526|NCT00560924|Drug|estradiol, 25 mcg|
16311527|NCT00560911|Behavioral|educational program for the self-management of OAC|"Patients in the self-management group participated in 4 consecutive weekly instruction sessions of 90 to 120 minutes each, in groups of 3 to 6 patients.
~After participation in the structured programme, the patients were encouraged to control their INR values by self-monitoring once a week and to adjust their anticoagulant dosage accordingly."
16311528|NCT00560911|Behavioral|1 hour education - afterwards physician leaded OAC control|"Patients in the routine control group participated a single 90-minute session
~During the whole study period, they were advised with regard to changes in the anticoagulant dosage by their usual attending physicians, either in general practice or at a hospital-based specialised anticoagulation clinic."
16311529|NCT00560898|Drug|ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
16311530|NCT00560898|Drug|Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
16311531|NCT00560898|Drug|Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
16311532|NCT00560898|Drug|ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution|Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
16311533|NCT00560885|Device|AtriCure Bipolar System|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
16311534|NCT00560872|Device|remote magnetic catheter navigation|use of the Stereotaxis system
16311535|NCT00560872|Procedure|cavotricuspid isthmus ablation|conventional (manual) approach
16311536|NCT00560859|Procedure|Adenotonsillectomy (AT) - removal of adenoids and tonsils|Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
16311538|NCT00560846|Dietary Supplement|Impact|Preoperative 5 day oral Impact and early post-operative enteral Impact
16311539|NCT00560846|Dietary Supplement|Glucose load|Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
16311540|NCT00560833|Drug|esmirtazapine|
16311541|NCT00560833|Drug|Placebo|
16311542|NCT00560820|Drug|Deferasirox|30 mg/kg/day
16311543|NCT00560807|Procedure|Mobilization|Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
16311544|NCT00560794|Biological|Blinatumomab (MT103)|Administered by continuous intravenous (CIV) over 4 weeks per cycle
16311545|NCT00560781|Drug|Pregnenolone or Placebo|Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
16311546|NCT00560768|Device|Ovatio VR 6250 or DR6550|"The study requires the implantation of locally approved material:
~A right ventricular defibrillation lead
~In case of use of a dual chamber ICD a right atrial pacing lead
~A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.
~Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar."
16311547|NCT00560755|Biological|ProQuad®|ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
16311548|NCT00560742|Procedure|Control|Coronary artery bypass grafting without bone marrow cells injection
16311549|NCT00560742|Procedure|Intramuscular administration of bone marrow cells|Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar
16311550|NCT00560742|Procedure|Intracoronary administration of bone marrow cells|Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar
16311551|NCT00560729|Dietary Supplement|Renutryl 500|
16311552|NCT00560729|Dietary Supplement|Generique|
16311553|NCT00560729|Dietary Supplement|Generique + Renutryl 500|
16311554|NCT00560716|Drug|CYC116|Dose escalation of CYC116
16311555|NCT00560703|Drug|COL-101 (doxycycline, USP) capsules|40mg, once per day for 84 days
16311556|NCT00560703|Drug|placebo|sugar capsule
16311557|NCT00560690|Drug|Metformin|500 mg oral three times a day for 6 months
16311558|NCT00560690|Drug|pegylated interferon|180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
16311559|NCT00560690|Drug|Ribavirin|800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
16311560|NCT00560664|Procedure|Autologous chondrocytes transplantation|Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.
16311561|NCT00560664|Procedure|Mosaicoplasty|Osteochondral patch are sampled and then implanted during the same surgical procedure
16311562|NCT00560651|Procedure|CCL (Corneal Cross Linking)|Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance
16311563|NCT00560638|Drug|loteprednol etabonate ophthalmic suspension, 0.5%|TID
16311564|NCT00560638|Drug|loteprednol etabonate ophthalmic suspension, 0.5%|QID
16311565|NCT00560638|Drug|vehicle of loteprednol etabonate|TID or BID according to the randomization
16311566|NCT00560612|Drug|Paroxetine|Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
16311567|NCT00560612|Drug|Placebo|Placebo: same as paroxetine (active comparator)
16311568|NCT00560599|Drug|mupirocin and chlorhexidine|"Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
~Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine."
16311569|NCT00560599|Behavioral|household cleaning and disinfection|Environmental cleaning with topical ethanol and laundering of clothes and linen.
16311570|NCT00560599|Drug|mupirocin, chlorhexidine, & household cleaning/disinfection|"Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
~Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine.
~Environmental cleaning with topical ethanol and laundering of clothes and linen."
16311571|NCT00560586|Drug|Budesonide|1 puff each nostril (32 micrograms) at bedtime
16311572|NCT00560586|Drug|placebo|1 puff each nostril at bedtime
16311573|NCT00560573|Drug|CP-751,871|CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).
16311574|NCT00560573|Drug|Cisplatin|"Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.
~* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine"
16311575|NCT00560573|Drug|Gemcitabine|Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles
16311576|NCT00560573|Drug|Pemetrexed|Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle
16311577|NCT00560560|Biological|CP-751, 871|Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
16311578|NCT00560547|Drug|methoxy polyethylene glycol-epoetin beta|120, 200 or 360 micrograms / 4 weeks iv (starting dose)
16311579|NCT00560534|Procedure|Whole body magnetic resonance angiography|Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.
16311580|NCT00560521|Behavioral|CPAP|Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.
16311581|NCT00560508|Drug|Pramipexole Immediate Release|titrated as individually needed (0.25 mg - 4.5 mg daily)
16311582|NCT00560508|Drug|Pramipexole Extended Release|titration as individually needed (0.375 mg -4.5 mg daily)
16311583|NCT00560495|Drug|ammonium tetrathiomolybdate|4 times daily for up to 3 weeks
16311584|NCT00560495|Other|immunoenzyme technique|
16311585|NCT00560495|Other|laboratory biomarker analysis|
16311586|NCT00560495|Radiation|Tc 99m sestamibi|
16311587|NCT00560495|Radiation|radiation therapy|once daily, 5 days a week, for 6-7 weeks
16311588|NCT00560482|Drug|ABR-215050, tasquinimod|Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
16311589|NCT00560482|Drug|Placebo|Identical appearing gelatin capsules containing placebo
16311590|NCT00560469|Other|Administration of 70% deuterated water|Subjects will drink 70% deuterated water daily for 8 weeks.
16311591|NCT00560456|Other|Chronic sleep restriction and driving simulator|"One night of normal sleep
~Driving simulator
~Night 1: night of total sleep deprivation
~Night 2: night of sleep recovery
~Night 1 to 5: nights of sleep restriction
~Driving simulator after night 1 to 5
~Night 6: night of sleep recovery
~Driving simulator"
16311592|NCT00560443|Drug|ketorolac|0,5 mg/kg per os one time
16311593|NCT00560443|Drug|tramadol|2,5 mg/ kg per os in one dose
16311594|NCT00560430|Drug|telmisartan|80 mg per day, orally, weeks 1-14
16311595|NCT00560430|Drug|telmisartan|80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
16311596|NCT00560430|Drug|placebo|placebo; orally weeks 1-14
16311597|NCT00560417|Drug|Insulin Lispro Protamine Suspension|Administered subcutaneously once a day at bedtime
16311598|NCT00560417|Drug|Insulin Glargine|Administered subcutaneously once a day at bedtime
16311599|NCT00560404|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc monthly (starting dose)
16311600|NCT00560404|Drug|Epoetin alfa|As prescribed
16311601|NCT00560391|Drug|Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg|Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
16311602|NCT00560391|Drug|Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg|Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
16311603|NCT00560391|Drug|Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg|Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
16311604|NCT00560391|Drug|Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg|Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
16311605|NCT00560391|Drug|Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg|Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
16311606|NCT00560378|Drug|Tacrolimus ointment 0.1%|Topical
16311607|NCT00560365|Other|laboratory biomarker analysis|
16311608|NCT00560365|Procedure|computed tomography|
16311609|NCT00560365|Procedure|magnetic resonance imaging|
16311610|NCT00560365|Procedure|quality-of-life assessment|
16311611|NCT00560352|Drug|Dasatinib|Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
16311612|NCT00560352|Drug|Bortezomib|Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m^2 QD, 1.3 mg/m^2 QD
16311613|NCT00560352|Drug|Dexamethasone|Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
16311614|NCT00560326|Drug|Tacrolimus Ointment 0.03%|Once or twice daily topical application
16311615|NCT00560313|Biological|Men ACWY CRM|A single dose of a 0.5 mL injectable solution
16311616|NCT00560313|Biological|4CMenB|All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
16311617|NCT00560300|Drug|1 alpha D2|Vitamin D sterol
16311618|NCT00560300|Drug|1,25 dihydroxy vitamin D3|Active vitamin D sterol
16311619|NCT00560300|Drug|Sevelamer HCl|Phosphate binder
16311620|NCT00560300|Drug|Calcium Carbonate|Phosphate binder
16311621|NCT00560287|Device|Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers|A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
16311622|NCT00560287|Device|Non invasive ventilation|A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
16311623|NCT00560274|Drug|Pegasys|As prescribed
16311624|NCT00560274|Drug|Ribavirin|As prescribed
16311625|NCT00560274|Drug|epoetin beta [NeoRecormon]|30,000 IU sc/week (starting dose)
16311626|NCT00560261|Other|NO-CO inhalation and expiration|NO-CO inhalation and expiration
16311627|NCT00560261|Other|NO-CO inhalation and expiration|NO-CO inhalation and expiration
16311628|NCT00560235|Drug|CP-751,871|Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
16311629|NCT00560222|Dietary Supplement|bovine lactoferrin|1gm of lactoferrin will be given each day
16311630|NCT00560222|Dietary Supplement|placebo [maltodextrin]|placebo that appears identical to lactoferrin will be given daily
16311631|NCT00560209|Drug|ONO-1101|placebo for 1 minute IV
16311632|NCT00560209|Drug|ONO-1101|0.06 mg/kg for 1 minute IV
16311633|NCT00560209|Drug|ONO-1101|0.125 mg/kg for 1 minute IV
16311634|NCT00560196|Other|Observation|
16311635|NCT00560183|Drug|Q8003 (morphine sulfate and oxycodone hydrochloride)|Capsules, four different mg dosage strengths
16311636|NCT00560183|Drug|Placebo|Capsules
16311637|NCT00560170|Drug|Simvastatin (Zocor)|40mg of Simvastatin (n=20) orally per-day for 28 days
16311638|NCT00560170|Drug|10mg/10mg of Ezetimibe/Simvastatin (Vytorin)|10mg/10mg of Ezetimibe/Simvastatin (n=20) orally per-day for 28 days
16311639|NCT00560157|Dietary Supplement|Crucial (enteral tube feeding)|Evaluation of new enteral product, Crucial, in ICU patients
16311640|NCT00560144|Drug|RG1507|3mg/kg iv weekly
16311641|NCT00560144|Drug|RG1507|9mg/kg iv weekly
16311642|NCT00560144|Drug|RG1507|Pharmacokinetic-derived dose, <=16mg/kg iv weekly
16311643|NCT00560118|Drug|fotemustine|
16311644|NCT00560118|Genetic|gene expression analysis|
16311645|NCT00560118|Genetic|polymerase chain reaction|
16311646|NCT00560105|Device|Lung Flute|8 weeks home use, twice daily
16311647|NCT00560105|Device|Acapella|8 weeks home use, twice daily
16311648|NCT00560092|Drug|intrathecal magnesium sulfate|intrathecal magnesium sulfate
16311649|NCT00560079|Drug|Allopurinol|Allopurinol 600mg/day bid for 28 days
16311650|NCT00560079|Drug|Dipyridamole|Dipyridamole 200mg/day bid for 28 days
16311651|NCT00560079|Drug|Placebo|Placebo
16311652|NCT00560066|Biological|Cell-derived influenza vaccine|1 dose of 0.5 mL in the deltoid region of the non-dominant arm
16311653|NCT00560066|Biological|Egg-derived influenza vaccine|1 dose of 0.5 mL in the deltoid region of the non-dominant arm
16311654|NCT00560053|Drug|Alternating chemotherapy|"4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.
~VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20."
16311655|NCT00560053|Procedure|Autologous Transplantation|"Autologous Transplantation :
~BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria"
16311656|NCT00560053|Drug|Maintenance|"At 3 months of transplantation or with >1.500 neutrophiles/ > 75.000 platelets mm 3 .
~Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse."
16311657|NCT00560053|Procedure|Second transplantation|In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
16311658|NCT00560053|Procedure|ALOGENIC MINI TRASPLANTATION|ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL
16311659|NCT00560027|Other|Case Management by Family Support Counselor (not RCT)|N/A. Had planned to study RCT of case management intervention but unable to carry out RCT. Instead studied screening practice and healthcare utilization in mothers with PPD, IPV or both.
16311660|NCT00560014|Dietary Supplement|Arginine and canola oil|Canola oil 1 tablespoon BID Arginine 9.0grams BID
16311661|NCT00560014|Dietary Supplement|Coromega and Arginine|Arginine 9.0 grams BID Coromega dose based on weight
16311662|NCT00560001|Behavioral|MD.2 Medication Dispenser|For those subjects receiving an MD.2 Medication Dispenser, the machine organizes medications and provides verbal and auditory explicit reminders for individuals to take their medications. At the scheduled time, the patient gets a series of reminders. The patient is then expected to push a single button to dispense a pre-filled medication cup. An automatic record is kept of the subject's medication adherence. Interviewer-administered surveys of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits will be given. Caregivers will complete the Caregiver Burden Interview.
16311663|NCT00559988|Drug|Home Monitoring Guided OAC|"Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy.
~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
16311664|NCT00559988|Drug|Physician-Directed OAC|"Patients will receive physician-directed anticoagulation therapy based on conventional criteria.
~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
16311665|NCT00559975|Biological|Subunit influenza vaccine|0.5 mL single dose vaccine
16311666|NCT00559975|Biological|Adjuvanted influenza vaccine|0.5 mL single dose vaccine
16311667|NCT00559975|Biological|Adjuvanted influenza vaccine combined with CpG7909|0.5 ml influenza vaccine combined with 10 mcg of CpG7909
16311668|NCT00559975|Biological|Adjuvanted influenza vaccine combine with CpG7909|0.5 mL single dose vaccine combined with 30 mcg of CpG7909
16311669|NCT00559975|Biological|Adjuvanted influenza vaccine combine with CpG7909|0.5 mL single dose vaccine combined with 100 mcg of CpG7909
16311670|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
16311671|NCT00559962|Drug|placebo|3 capsules each evening for each 4-week period
16311672|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
16311673|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
16311674|NCT00559962|Drug|AEGR-733|3 capsules each evening for each 4-week period
16311675|NCT00559962|Drug|AEGR-733 and atorvastatin|3 capsules each evening for each 4-week period
16311676|NCT00559962|Drug|AEGR-733 and fenofibrate|3 capsules each evening for each 4-week period
16311677|NCT00559962|Drug|AEGR-733 and ezetimibe|3 capsules each evening for each 4-week period
16311678|NCT00559949|Other|Laboratory Biomarker Analysis|Correlative studies
16311679|NCT00559949|Drug|Selumetinib|Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary.
16311680|NCT00559936|Drug|Topical Avastin 1%|Avastin (bevacizumab) 1%
16311681|NCT00559910|Drug|PH-797804|PH-797804 at four dose levels
16311682|NCT00559910|Drug|Placebo|Placebo
16311683|NCT00559897|Other|3'-deoxy-3'-[18F]FLT|Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
16311684|NCT00559897|Procedure|Single photon emission computed tomography|Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
16311685|NCT00559884|Drug|GSK189075 (Modified and immediate release formulations)|
16311686|NCT00559871|Drug|fipamezole|Fipamezole in Zydis formulation three times per day for up to 28 days
16311687|NCT00559858|Dietary Supplement|pyridoxine hydrochloride|
16311688|NCT00559858|Other|placebo|
16311689|NCT00559858|Procedure|quality-of-life assessment|
16311690|NCT00559845|Drug|5-fluorouracil|600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
16311691|NCT00559845|Drug|Epidoxorubicin|90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
16311692|NCT00559845|Drug|Cyclophosphamide|600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
16311693|NCT00559845|Drug|Paclitaxel|Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.
16311694|NCT00559845|Biological|Bevacizumab|Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
16311695|NCT00559832|Other|Hypoxic Exposure|Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
16311696|NCT00559819|Drug|placebo|Placebo (orange juice), same volume as alcohol
16311697|NCT00559819|Drug|Alcohol|Dose with Alcohol (Vodka) to make blood alcohol concentration 0.08%
16311698|NCT00559806|Other|2 weeks of unilateral immobilisation and 4 weeks of resistance training|2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
16311699|NCT00559806|Other|2 weeks of unilateral immobilisation and 4 weeks of resistance training|2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
16311700|NCT00559780|Behavioral|Resistance training|12 weeks of resistance training (3/week)
16311701|NCT00559780|Behavioral|Neuromuscular electrical stimulation of the quadriceps muscle|12 weeks of neuromuscular electrical stimulation of the quadriceps muscle (1h/day)
16311702|NCT00559780|Behavioral|Standard rehabilitation|12 weeks of standard physiotherapy exercises (1h/day)
16311703|NCT00559754|Drug|bevacizumab [Avastin]|15mg/kg iv on day 1 of each 3 week cycle
16311704|NCT00559754|Drug|Docetaxel|75mg/m2 iv on day 1 of each 3 week cycle
16311705|NCT00559754|Drug|Standard chemotherapy|As prescribed
16311706|NCT00559741|Biological|cetuximab|
16311707|NCT00559741|Drug|fluorouracil|
16311708|NCT00559741|Drug|irinotecan hydrochloride|
16311709|NCT00559741|Drug|leucovorin calcium|
16311710|NCT00559741|Other|pharmacological study|
16311711|NCT00559715|Drug|bevacizumab|1.25 mg intravitreally monthly/on demand
16311712|NCT00559715|Drug|ranibizumab|0.5 mg intravitreally monthly/on demand
16311713|NCT00559702|Drug|natalizumab|natalizumab
16311714|NCT00559702|Other|standard of care|standard of care as determined by the Investigator and Treating Neurologist
16311715|NCT00559689|Drug|Budesonide,hydrofluoroalkane-beclomethasone dipropionate|receive twice-daily administration
16311716|NCT00559689|Drug|Budesonide,hydrofluoroalkane-beclomethasone|once-daily administration at bedtime
16311717|NCT00559676|Drug|capecitabine|
16311718|NCT00559676|Drug|fluorouracil|
16311719|NCT00559676|Drug|irinotecan hydrochloride|
16311720|NCT00559676|Drug|leucovorin calcium|
16311721|NCT00559676|Drug|oxaliplatin|
16311722|NCT00559676|Other|laboratory biomarker analysis|
16311723|NCT00559676|Other|pharmacological study|
16311724|NCT00559663|Dietary Supplement|Green tea|"The green tea group consumed first daily one liter of green tea infusate made of 4 bags left in boiling water during 3 minutes.
~After a four week washout-time they were switched over to the dark chocolate treatment, which included consumption of 3.5 ounces 70% dark chocolate.
~Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels"
16311725|NCT00559663|Dietary Supplement|70% dark chocolate|"The dark chocolate group consumed 3.5 ounces 70% dark chocolate per day during a one week period.
~After a four week washout-time they were given the green tea treatment, which included ingestion of one liter green tea infusate (containing 4 green tea bags).
~Blood was drawn before and after each intervention, to check platelet activity with flow cytometry, HDL, LDL and hsCRP Levels."
16311726|NCT00559650|Drug|Placebo|Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
16311727|NCT00559650|Drug|Cinaciguat (BAY58-2667)|Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
16311728|NCT00559637|Drug|Methoxy polyethylene glycol-epoetin beta|Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
16311729|NCT00559624|Drug|Acadesine|For part I of the study one 4 hour intravenous infusion will be given. In part II upto five 4 hour intravenous infusions will be given over 20 days.
16311730|NCT00559611|Procedure|Endobronchial Ultrasound|A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
16311731|NCT00559611|Procedure|Mediastinoscopy|Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.
16311732|NCT00559598|Genetic|proteomic profiling|
16311733|NCT00559598|Other|medical chart review|
16311856|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7 and day 14
16311734|NCT00559585|Drug|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
16311735|NCT00559585|Drug|Intravenous (IV) Abatacept|"Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
~500mg (for body weight up to 60 kg)
~750 mg (body weight between 61 and 100 kg)
~1g (body weight above 100 kg)infusions"
16311736|NCT00559572|Behavioral|Motivational group sessions|Motivational group sessions include 4 weeks of weekly 1-hour exercise information sessions.
16311737|NCT00559572|Other|Time and attention control group sessions|Time and attention control group sessions include 4 weeks of weekly 1-hour general health information sessions.
16311738|NCT00559559|Device|ICD implant + Patient Notifier turned OFF|ICD implant, plus standard care, i.e. Patient Notifier turned off
16311739|NCT00559559|Procedure|ICD Implant + Patient Notifier turned ON|ICD implant. The Patient Notifier™ feature will be turned ON.
16311740|NCT00559546|Drug|montelukast|10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
16311741|NCT00559533|Drug|RO5045337|Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)
16311742|NCT00559520|Dietary Supplement|Impact|"Patient receiving 3 drinks Impact a day during 5 days before surgery"
16311743|NCT00559520|Dietary Supplement|Oral Impact|"Patient receiving 3 drinks Oral Impact a day during 5 days before surgery"
16311744|NCT00559507|Drug|saracatinib|
16311745|NCT00559507|Other|laboratory biomarker analysis|Correlative studies
16311746|NCT00559494|Drug|Minocycline|Minocycline IV BID x 7 days (first 10 patients 200 mg/dose, subsequent patients adjusted based on pharmacodynamic profiling to 800 mg loading dose, tapered 100 mg each dose to 400 mg then maintain at 400mg until day 7)
16311747|NCT00559494|Drug|placebo|Normal saline 250cc via central line similar to minocycline arm administration protocol
16311748|NCT00559494|Procedure|SCPP augmentation|maintenance of spinal cord perfusion pressure at 75 mmHg with fluids and inotrope protocol
16311749|NCT00559494|Procedure|SCPP control|maintenance of Mean arterial pressure of >65 mmHg with fluids and inotropes protocol without spinal cord perfusion pressure as target or guiding therapy
16311750|NCT00559481|Drug|dexamethasone|
16311751|NCT00559481|Drug|ketoconazole|
16311752|NCT00559481|Drug|therapeutic hydrocortisone|
16311753|NCT00559481|Procedure|pharmacological study|
16311754|NCT00559468|Drug|Sugammadex|Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
16311755|NCT00559468|Drug|Rocuronium|Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
16311756|NCT00559468|Drug|Sevoflurane|Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
16311757|NCT00559468|Drug|Propofol|Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
16311758|NCT00559455|Drug|Oxaliplatin|85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
16311759|NCT00559455|Drug|Fluorouracil|400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks
16311760|NCT00559455|Drug|Leucovorin|200mg/m², Day 1 and Day 2; Every 2 weeks
16311761|NCT00559442|Other|Altitude Exposure:|rapid ascent to Margherita Hut (4559 m) within 24 h
16311762|NCT00559429|Drug|Docetaxel|Docetaxel 50mg/m2 IV on day 1 and day 22
16311763|NCT00559429|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 and day 22
16311764|NCT00559429|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 and day 22
16311765|NCT00559429|Drug|Docetaxel|Docetaxel 75 mg/m2 IV on day 1, 22 and day 43
16311766|NCT00559416|Drug|Cell Transfer|
16311767|NCT00559403|Behavioral|HIV/STD Risk-Reduction|Let Us Protect Our Future consists of twelve 1-hour sessions to increase knowledge, motivation, and skills in practicing abstinence and condom use. It is highly structured, and Xhosa-speaking male and female co-facilitators implement the program using standardized manuals. Treatment sessions include mixed-gender and single-gender activities, games, brainstorming, and role-playing. Comic workbooks are used to address abstinence, condom use, and how risky behavior affects goals and dreams. The Xhosa culture is taken into account, including cultural transformations in urban township settings. Take-home assignments enlist parents' help to empower their children to reduce their STD risk and ensure that parents are aware of the nature of the treatment program.
16311768|NCT00559403|Behavioral|Health Promotion|The health promotion treatment is structurally similar to the HIV/STD treatment: each has the same number of sessions and sessions led by Xhosa-speaking male and female co-facilitators. It focuses on behaviors linked with risk of heart disease, diabetes, high blood pressure, certain cancers, and alcohol and drug abuse, which are all leading causes of morbidity and mortality among South Africans. Participants are taught that healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance use, can prevent these health problems. Comic workbook story lines are used to increase risk perception and awareness of health risks. Take-home assignments are used to foster communication with parents about healthful lifestyle.
16311769|NCT00559377|Other|18F-fluoromisonidazole|Undergo ^18F FMISO PET scan
16311770|NCT00559377|Radiation|fluorodeoxyglucose F 18|Undergo ^18F FDG PET scan
16311771|NCT00559377|Procedure|positron emission tomography|Undergo ^18F-FMISO and ^18F FDG PET scan
16311772|NCT00559377|Other|tissue oxygen measurement|Undergo ^18 F FMISO PET and ^18F FDG PET
16311773|NCT00559364|Drug|Viokase® 16|Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
16311774|NCT00559364|Drug|Placebo|Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.
16311775|NCT00559364|Drug|Proton pump inhibitor (PPI)|Patients on PPI during Screening will continue their usual PPI therapy throughout the study.
16311776|NCT00559364|Drug|Omeprazole|Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.
16311777|NCT00559351|Procedure|transthoracic esophagectomy 2-field extended lymphadenectomy|right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck
16311778|NCT00559351|Drug|neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)|21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
16311779|NCT00559351|Radiation|neoadjuvant chemoradiotherapy|21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
16311780|NCT00559338|Drug|recombinant B-type, natriuretic peptide|The intravenous infusion of nesiritide consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The nesiritide was mixed in 250 ml of 0.9% normal saline solution.
16311781|NCT00559338|Drug|placebo|The intravenous infusion of placebo consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The placebo was mixed in 250 ml of 0.9% normal saline solution.
16311782|NCT00559312|Drug|fluticasone/salmeterol combination|Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration
16311783|NCT00559312|Drug|placebo|Placebo Diskus inhaler, twice daily, 6-week duration
16311784|NCT00559299|Drug|GSK163090|
16311785|NCT00559286|Drug|Telmisartan|application of 80mg or 20mg Telmisartan per day for 30 days
16311786|NCT00559273|Drug|Methoxy polyethylene glycol-epoetin beta|1.2 mcg/kg SC monthly, starting dose
16311787|NCT00559273|Drug|Darbepoetin alfa|0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
16311788|NCT00559260|Device|Passive monitoring with pulse-oximetry, NIBP and ECG|
16311789|NCT00559247|Drug|BMS-650032 or Placebo|Oral, Once daily, Single Dose
16311790|NCT00559221|Drug|FLAG+IDA|Fludarabine, cytarabine, G-CSF
16311791|NCT00559195|Biological|epoetin beta|
16311792|NCT00559195|Procedure|quality-of-life assessment|
16311793|NCT00559182|Drug|Comparator: MK-8033|"MK-8033 will be administered as an oral formulation in sequentially rising dose levels starting at 50 mg and continuing at 100% dose increments until dose level 4 (800 mg total daily dose). Dose levels 5 to 11 will be escalated at ~40% dose increments until 3000mg (total daily dose). The daily dose of MK-8033 will be divided into two equal doses. MK-8033 will be administered in a first cycle of 14 days (continuous drug administration from Day 1 through Day 14), followed by a 1 week drug holiday (Cycle 1, Day 15 through Day 21). Subsequent cycles of MK-8033 will be administered for 14 days (Cycles 2 to 4) and 28 days (Cycle 5 and beyond).
~Enrollment in Parts A and B has been completed."
16311794|NCT00559182|Drug|Comparator: MK-8033 +/- omeprazole|"Part C will occur at only one of the investigational sites.
~In Cycle 1, patients will be randomized to one of two treatment sequences, A/B or B/A, over two treatment periods. Treatment A: 770 mg MK-8033 twice daily with co-administration of 20 mg omeprazole once daily. Treatment B: 770 mg MK-8033 twice daily. After Cycle 1 is complete, patients may continue to receive MK-8033 until disease progression or unacceptable toxicity.
~Enrollment for Part C has been suspended."
16311795|NCT00559169|Drug|verapamil hyrochloride|80 mg daily by mouth, 5 days prior to menses for 3 months
16311796|NCT00559156|Dietary Supplement|arginine/omega-3 fatty acids/nucleotides oral supplement|
16311797|NCT00559156|Drug|cisplatin|
16311798|NCT00559156|Procedure|adjuvant therapy|
16311799|NCT00559156|Radiation|radiation therapy|
16311800|NCT00559143|Other|Biventricular Pacing (DDD(R)- BiV)|Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV
16311801|NCT00559130|Device|CytoSorb Hemoperfusion|Daily hemoperfusion for 6 hours with CytoSorb device
16311802|NCT00559117|Drug|VB-111|A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute
16311803|NCT00559104|Drug|carmustine|Unique to the Carmustine in Conditioning arm
16311804|NCT00559104|Drug|cyclophosphamide|Used in Both Arms
16311805|NCT00559104|Drug|etoposide|Used in Both Arms
16311806|NCT00559104|Procedure|autologous hematopoietic stem cell transplantation|Both arms are given autologous stem cell transplantation
16311807|NCT00559104|Procedure|peripheral blood stem cell transplantation|Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).
16311808|NCT00559104|Radiation|total-body irradiation|Unique to the Radiation in Conditioning Arm
16311809|NCT00559104|Drug|G-CSF|G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
16311810|NCT00559091|Drug|ribavirin|Ribavirin will be administered orally, twice daily, in the morning and evening with food. The dose selected is 400 mg AM and 600 mg PM. Intrapatient dose escalations can also be performed in defined circumstances. The maximal dose administered will be 1000 mg AM and 1000 mg PM.
16311811|NCT00559078|Other|Interview|Hour-long, qualitative, phone interview
16311812|NCT00559052|Drug|VIOKASE 16|The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.
16311813|NCT00559039|Other|questionnaire administration|
16311814|NCT00559039|Procedure|evaluation of cancer risk factors|
16311815|NCT00559026|Biological|Melan-A|i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses
16311816|NCT00559026|Other|Melan-A plus Dacarbazine|Dacarbazine plus vaccine: the vaccination schedule as in arm 1 was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.
16311817|NCT00559013|Device|Staple line reinforcement|Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
16311818|NCT00559000|Behavioral|KIDNET|Narrative Exposure Therapy for Children
16311920|NCT00558220|Procedure|immunotherapy|"Given together with induction chemotherapy:
~Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses"
16311819|NCT00558987|Behavioral|Discipline Video|"The discipline video will be shown to the caregiver before the visit while they are waiting to see the doctor. The video gives specific guidance on avoiding physical discipline, setting consistent, safe and age appropriate limits.
~A copy of the discipline video and the handout reinforcing the messages presented in the video will be given to the caregiver by the research staff to share with other caregivers."
16311820|NCT00558987|Behavioral|Nutrition Video|A brief educational video on nutrition information, a topic not related to discipline.
16311821|NCT00558961|Drug|Gleevec and Chlorambucil|The first cohort will receive Gleevec at 300 mg daily on days 1-10 and chlorambucil 8mg/m2/d from day 3-7. This will be repeated every 28 days. Cohort 2 will receive 400 mg Gleevec and Cohort 3 will receive 600 mg Gleevec. Each dose level may be expanded up to 6 patients if 1 of 3 patients experiences any dose limiting toxicities.
16311822|NCT00558935|Dietary Supplement|Red Wine|20g alcohol daily/red wine for 4 weeks
16311823|NCT00558922|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1.
16311824|NCT00558909|Drug|BI 44847|
16311825|NCT00558909|Drug|placebo for BI 44847|
16311826|NCT00558896|Drug|dexamethasone|40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.
16311827|NCT00558896|Drug|pomalidomide|2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
16311828|NCT00558883|Drug|acarbose|oral application
16311829|NCT00558870|Drug|Morphine|"Arm 1: 2 Doses of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).Immediate-release morphine may be used, if needed, for pain."
16311830|NCT00558870|Drug|Methadone|"1 Dose of Methadone PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)
~Arm 2: 1 Dose of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).).Immediate-release morphine may be used, if needed, for pain."
16311831|NCT00558857|Device|Dynamic Substrate Mapping-guided ablation|Radiofrequency ablation
16311832|NCT00558844|Drug|Arikayce™ 560 mg|"Arikayce™ at 560 mg
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
16311833|NCT00558844|Drug|Placebo for 560 mg|"Matching placebo
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
16311834|NCT00558844|Drug|Arikayce™ 70 mg|Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16311835|NCT00558844|Drug|Arikayce™ 140 mg|Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
16311836|NCT00558844|Drug|Placebo for 70 mg / 140 mg|"Matching placebo
~Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer."
16311837|NCT00558831|Drug|Benzoyl Peroxide|Benzoyl Peroxide 2.5%
16311838|NCT00558831|Drug|Moisturizing Lotion|
16311839|NCT00558818|Drug|Clevudine|clevudine 30 mg qd
16311840|NCT00558805|Behavioral|FISP + Usual Care|
16311841|NCT00558805|Behavioral|Usual Care|
16311842|NCT00558792|Drug|Isovue 370, 70 mL|70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
16311843|NCT00558792|Drug|Isovue 370, 80 mL|80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
16311844|NCT00558792|Drug|Isovue 370, 90 mL|90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
16311845|NCT00558779|Procedure|OBCAB (Off Pump Coronary Artery Bypass Grafting)|OPCAB with sparing of aortic manipulation (eg, no aortic cannulation for cardiopulmonary bypass, no aortic cross-clamp, no side-clamping of the aorta). Graft anastomosis to the central circulation with y-grafts on the arteria thoracica interna or on the aorta with help of the Heart-string-system (Guidant)
16311846|NCT00558779|Procedure|CABG (coronary artery bypass grafting)|conventional CABG with cardiopulmonary bypass
16311847|NCT00558753|Drug|pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
16311848|NCT00558753|Drug|Placebo|Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
16311849|NCT00558740|Other|high protein intake|acute high protein intake chronic (6-day) high protein intake acute+chronic high protein intake control
16311850|NCT00558727|Drug|RH-1|1.5 mg/m2 to 12 mg/m2, depending on protocol cohort, administered via intravenous (IV) infusion over 3 hours once every 21 days.
16311851|NCT00558701|Device|Microcurrent stimulator|Microcurrent stimulation from 15-50 microamps
16311852|NCT00558701|Device|Silverlon Wound Contact Dressing|Silver coated nylon dressing FDA approved for use on donor sites in burn patients
16311853|NCT00558688|Procedure|Photodynamic therapy|Photodynamic therapy applied to actinic keratoses
16311854|NCT00558675|Biological|AlloStim|single intravenous infusion of 1 x 10^9 AlloStim cells
16311855|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7
16311857|NCT00558675|Biological|AlloStim|Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7, day 14 and day 21
16311858|NCT00558662|Device|Coban 2|Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.
16311859|NCT00558662|Device|SSB|Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.
16311860|NCT00558649|Biological|Flu Vaccine (FLUARIX®)|Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
16311861|NCT00558636|Drug|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
16311862|NCT00558636|Drug|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
16311863|NCT00558623|Dietary Supplement|calcium carbonate|daily supplement of 1,200 milligrams calcium (two-600 mg tablets calcium carbonate at bedtime)
16311864|NCT00558584|Device|protein A immunoadsorption|protein-A immunoadsorption and i.v. IgG substitution
16311865|NCT00558584|Device|pseudo-immunoadsorption|pseudo-immunoadsorption followed by an intravenous infusion without IgG
16311866|NCT00558571|Drug|BI 10773 low dose|
16311867|NCT00558571|Drug|placebo to BI 10773|
16311868|NCT00558571|Drug|BI 10773 medium dose|
16311869|NCT00558571|Drug|BI 10773 high dose|
16311870|NCT00558558|Drug|Haelan|4 oz orally twice daily for 8 Weeks
16311871|NCT00558545|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly only on weeks when paclitaxel is administered, with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1.
16311872|NCT00558532|Procedure|Bariatric Surgery|Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery
16311873|NCT00558519|Drug|cyclophosphamide|
16311874|NCT00558519|Drug|cytarabine|
16311875|NCT00558519|Drug|daunorubicin hydrochloride|
16311876|NCT00558519|Drug|dexamethasone|
16311877|NCT00558519|Drug|doxorubicin hydrochloride|
16311878|NCT00558519|Drug|mercaptopurine|
16311879|NCT00558519|Drug|methotrexate|
16311880|NCT00558519|Drug|pegaspargase|
16311881|NCT00558519|Drug|thioguanine|
16311882|NCT00558519|Drug|vincristine sulfate|
16311883|NCT00558519|Radiation|radiation therapy|
16311884|NCT00558506|Drug|abatacept|intravenously 750mg (in patients with weight of 60- 100kg)
16311885|NCT00558493|Drug|Clevudine|clevudine 30 mg qd for 24 seeks
16311886|NCT00558480|Drug|Vitamin A|Vitamin A capsules, as retinol palmitate 200,000 IU at enrollment, 3 and 6 months
16311887|NCT00558480|Drug|Vitamin A placebo|Vitamin A placebo at enrollment, 3 and 6 months
16311888|NCT00558467|Drug|pramipexole immediate release (IR)|
16311889|NCT00558467|Drug|Placebo|
16311890|NCT00558454|Drug|Iron|Ferrous succinate mixture
16311891|NCT00558441|Device|IVMRI|Intra Vascular Magnetic Resonance Imaging
16311892|NCT00558428|Drug|fixed dose combination of telmisartan+amlodipine|
16311893|NCT00558428|Drug|amlodipine|
16311894|NCT00558402|Behavioral|Meditation|meditation class 1/week for 8 weeks
16311895|NCT00558402|Behavioral|Education|Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers
16311896|NCT00558402|Behavioral|Respite only|Respite care 90 mins per week for 8 weeks
16311897|NCT00558376|Drug|polyethylene glycol|Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy
16311898|NCT00558376|Drug|Sodium phosphate|Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy
16311899|NCT00558363|Drug|Avodart|0.5 mg administered orally once daily
16311900|NCT00558363|Other|placebo|Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo
16311901|NCT00558337|Drug|levodopa-carbidopa|novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
16311902|NCT00558324|Procedure|LASIK|Mechanical microkeratome Hansatome 160 microns
16311903|NCT00558324|Procedure|LASIK|Mechanical microkeratome K 3000 130 microns
16311904|NCT00558324|Procedure|LASIK|Femtoseconds laser 100 microns
16311905|NCT00558311|Drug|Clazosentan|Intravenous clazosentan administered by continuous infusion at 5 mg/h
16311906|NCT00558311|Drug|Placebo|Placebo administered by continuous infusion matching clazosentan administration
16311907|NCT00558298|Drug|risperidone|
16311908|NCT00558285|Drug|indacaterol/glycopyrrolate|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
16311909|NCT00558285|Drug|indacaterol|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
16311910|NCT00558285|Drug|glycopyrrolate|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
16311911|NCT00558285|Drug|placebo|Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
16311912|NCT00558272|Drug|AZD0530|Daily oral dose
16311913|NCT00558272|Drug|Zoledronic Acid|
16311914|NCT00558259|Drug|dabigatran etexilate 150 mg twice daily (BID)|dabigatran etexilate capsules 150 mg BID
16311915|NCT00558259|Drug|matching placebo twice daily (BID)|Matching placebo BID
16311916|NCT00558246|Device|Dermabond Protape (Prineo)|cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
16311917|NCT00558246|Device|Suture|Topical Suturing
16311918|NCT00558233|Behavioral|CHOICE decision aid|computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
16311919|NCT00558233|Behavioral|YourMeds patient education program|computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
16311921|NCT00558220|Procedure|Induction treatment part 1|"cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks.
~3 cycles consisting of combination treatment of above mentioned drugs are given."
16311922|NCT00558220|Procedure|Induction treatment part 2 with PBPC collection|"Starts three weeks after last cycle of Induction part 1.
~Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection.
~Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are >20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood."
16311923|NCT00558220|Procedure|Induction treatment part 3|"Part 3 of induction treatment is given approximately one week after the end of Part 2.
~Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart."
16311924|NCT00558220|Procedure|Consolidation treatment part 1: HD-chemotherapy with ASCT|"Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3.
~High dose chemotherapy (HD-chemotherapy) consists of:
~BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6.
~On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery."
16311925|NCT00558220|Radiation|Consolidation treatment part 2: Radiotherapy|Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.
16311926|NCT00558207|Drug|ARQ 197|120 mg capsule administered twice daily for 240 mg total daily dose
16311927|NCT00558207|Drug|gemcitabine|1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week.
16311928|NCT00558194|Behavioral|Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training|12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
16311929|NCT00558194|Behavioral|Standard Behavioral Weight Loss Treatment|12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
16311930|NCT00558181|Drug|rituximab, methylprednisolone|Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.
16311931|NCT00558155|Drug|peptisorb|standard isocaloric eteral diet (1 ml = 1 kcal)
16311932|NCT00558155|Drug|Stresson|Oligopeptic, enteral diet (1 ml=1.25 kcal)
16311933|NCT00558155|Drug|Parenteral nutrition|Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
16311934|NCT00558155|Drug|Omegaven, Dipeptiven|Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
16311935|NCT00558142|Drug|Acetylcysteine|Participants will receive packs of either 8 placebo capsules or 8 acetylcysteine (600mg) capsules. They will be asked to take 2 tablets at 08.00 and 22.00 on the day before the study and the day of the study. On the day of the study participants will receive an IV infusion of either normal saline or acetylcysteine (200mg/kg)
16311936|NCT00558142|Drug|Visipaque 320|100mls IV dose as single dose
16311937|NCT00558142|Drug|Visipaque 320|The dose of Visipaque will be administered by the consultant cardiologist performing the coronary angiography
16311938|NCT00558129|Device|X-STOP®|Surgical implantation of X-STOP IPD device
16311939|NCT00558129|Procedure|Laminectomy|Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.
16311940|NCT00558116|Device|Dynamic splinting|The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
16311941|NCT00558103|Drug|lapatinib|Oral administration
16311942|NCT00558103|Drug|Pazopanib|Oral administration
16311943|NCT00558090|Drug|morphine|patients receive 7,5 mg morphine iv 30 minutes before intervention (turning of the patient), the day after admission in the ICU. before, during and after, the patient will be asked to rate the pain using the NRS
16311944|NCT00558077|Drug|Metformin plus clomiphene citrate|Metformin administration will start from 3rd day of a P-induced withdrawal bleeding with a dose of 850 mg (1 tablet daily) and increasing the dosage after one week up to 1700 mg/day (two tablets daily). Clomiphene citrate CC will be administered for five days beginning on cycle day 3rd of a P-induced withdrawal bleeding using a starting dose of 50 mg daily. If ovulation will not occur, the dose will be increased by 50 mg in successive cycles until the ovulation will be achieved or up to a maximal dose of 150 mg daily.
16311945|NCT00558077|Procedure|Laparoscopic ovarian drilling|Laparoscopic ovarian drilling will be performed as follows: according to ovary size three to six punctures will be performed at each ovary inserting an insulated needle cautery of 36 mm perpendicularly as possible to the ovarian surface with a cutting current of 100 watt power. Then, the needle will be activated for 2-3 seconds at each point using a coagulating current of 40 watt power. At completion of the procedure, the ovarian surface will be washed with a crystalloid solution and all injured areas will be completely covered with hyaluronic acid gel.
16311946|NCT00558064|Drug|telmisartan+amlodipine|
16311947|NCT00558064|Drug|amlodipine|
16311948|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 4 intradermal injections once a day for 4 days.
16311949|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 1 intranodal injection.
16311950|NCT00558051|Biological|DC-based vaccine|Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of a 4-day intralymphatic infusion.
16311951|NCT00558038|Drug|AST-120|AST-120
16311952|NCT00558038|Drug|lactulose|lactulose
16311953|NCT00558025|Drug|Pramipexole Extended Release|
16311954|NCT00558025|Drug|Pramipexole Immediate Release|
16311955|NCT00558012|Drug|Intravenous zoledronic acid|Intravenous zoledronic acid 5.0 mg once
16311956|NCT00558012|Dietary Supplement|Vitamin D 800 IU/daily|Daily divided dose
16311957|NCT00558012|Dietary Supplement|Calcium 1200 mg/daily|supplement plus diet
16311958|NCT00557999|Other|Application of mechanical ventilation weaning protocol|Application protocol for 8 months in experimental group
16311959|NCT00557986|Procedure|Primary surgery|Primary breast surgery before systemic therapy
16311960|NCT00557973|Drug|XP19986 SR1, 10 mg BID|XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
16311961|NCT00557973|Drug|XP19986 SR1, 20 mg BID|XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
16311962|NCT00557973|Drug|XP19986 SR1, 30 mg BID|XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
16311963|NCT00557973|Drug|Placebo|Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.
16311964|NCT00557960|Drug|Mixed salts of a single-entity amphetamine|
16311965|NCT00557960|Drug|Atomoxetine hydrochloride|
16311966|NCT00557947|Device|Suture|intradermal and topical suturing
16311967|NCT00557947|Device|Dermabond Protape (Prineo)|cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
16311968|NCT00557934|Other|dobutamine|dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
16311969|NCT00557921|Drug|CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin|(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
16311970|NCT00557921|Drug|Plavix (clopidogrel 75 mg) and aspirin|(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
16311971|NCT00557908|Drug|VWF/FVIII products|"Participants in the prospective phase of the study undergo an escalation of treatment from receipt of one to three levels of VWD product. All subjects enrolled will begin treatment on the level one and remain on this regimen for the duration of follow-up, or until they meet the criteria for escalation to level two or three (if indeed they do meet the criteria.)
~Dosing for joint bleeding, epistaxis, and GI bleeding indications: 50 U RCo/kg once per week, 50 U RCo/kg twice per week, or 50 U RCo/kg three times per week.
~Dosing for menorrhagia: 50 U RCo/kg on day 1 of menses for 2 cycles, 50 U RCo/kg on days 1 and 2 of menses for 2 cycles, or 50 U RCo/kg on days 1, 2, and 3 of menses"
16311972|NCT00557882|Device|synthetic polypropylene mesh|Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
16311973|NCT00557856|Drug|PF-03446962|To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.
16311974|NCT00557843|Drug|Bupivacaine|Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
16311975|NCT00557843|Drug|Saline|Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
16311976|NCT00557830|Drug|Sorafenib Escalated Dose|Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
16311977|NCT00557830|Drug|Sorafenib Standard Dose|Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
16311978|NCT00557817|Drug|Darbepoetin alpha (Aranesp)|Darbepoetin alpha (Aranesp) will be administered subcutaneously (s.c.) at the dose of 300 µg. The first dose will be given on day 28 and the following doses at 2-week intervals around days 42, 56, 70, 84, 98 and 112 post-transplant. Once the target Hb (13 g/dL) has been attained, the dose of Aranesp will be reduced by half to 150 µg. If the Hb increases to > 14 g/dL, Aranesp will be withheld and resumed at the dose of 150 µg when the Hb decreases < 13 g/dL. If the Hb decreases to < 12 g/dL, the dose of Aranesp will be increased to 300 µg again.
16311979|NCT00557817|Drug|Iron saccharate (Venofer)|Iron saccharate (Venofer) will be administered intravenously (i.v.) at the dose of 200 mg (2 vials of Venofer) on days 28, 42 and 56 after the transplant. Venofer will be diluted in 250 ml saline and infused over 60 minutes. Iron will be omitted in patients with severe iron overload (serum ferritin > 2500 µg/L in the absence of inflammation or liver necrosis) or elevated transferrin saturation (TS > 60%) between days 21 and 56. No iron supplementation will be allowed in arm 1. No iron supplementation will be allowed in arm 2 before day 70 after the transplant. In arms 2 and 3, if patients have evidence of functional iron deficiency (transferrin saturation < 20%) on day 70 or later, they will receive 300 mg of Venofer over 90 min, for a minimum of 2 doses.
16311980|NCT00557804|Device|MUSE clinical system|non-invasive external monitoring device
16311981|NCT00557791|Drug|Bevasiranib|Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
16311982|NCT00557791|Drug|ranibizumab|Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
16311983|NCT00557752|Device|Non-invasive ventilation|Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
16311984|NCT00557739|Drug|mometasone furoate|Topical 0.1% mometasone furoate
16311985|NCT00557739|Drug|nortriptyline HCl|Topical 0.05% or 0.1% nortriptyline HCl
16311986|NCT00557739|Drug|Vehicle (placebo)|Topical placebo
16311987|NCT00557713|Drug|bevacizumab|"-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
~-Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
~-Surgery (6-8 weeks after last bevacizumab dose)
~-Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)"
16311988|NCT00557700|Drug|Administration of inhaled tiotropium bromide|Administration of inhaled tiotropium bromide
16311989|NCT00557700|Drug|Administration of placebo|Administration of placebo
16311990|NCT00557661|Drug|CD-NP|24 hr intravenous infusion
16311991|NCT00557648|Behavioral|Group CBT for children|CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
16311992|NCT00557648|Behavioral|Group CBT for children plus parent training|CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.
16311993|NCT00557635|Procedure|Chirurgical procedure|Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
16311994|NCT00557622|Drug|paroxetine|BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD)
16311995|NCT00557622|Other|placebo|placebo
16311996|NCT00557609|Drug|ARQ 197|360 mg administered twice daily until disease progression or other discontinuation criterion is met
16311997|NCT00557596|Drug|AEG35156|AEG35156 will be given as a 2-hour intravenous infusion once weekly, only on weeks when gemcitabine is administered, with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1
16311998|NCT00557583|Drug|VBY 376|Doses of 50mg and higher or placebo will be evaluated.
16311999|NCT00557557|Drug|Drug: 5-FU|Dose escalation (200 to 900 mg/m²) scheme, one hour isolated hepatic perfusion prior to standard treatment.
16312000|NCT00557557|Drug|Drug: Oxaliplatin|40 mg/m², one hour isolated hepatic perfusion prior to standard treatment.
16312001|NCT00557544|Drug|metoclopramide|metoclopramide 0,15 mg/kg
16312002|NCT00557544|Drug|placebo|placebo per os
16312003|NCT00557544|Drug|ketoprofen|ketoprofen 1 mg/Kg
16312004|NCT00557531|Device|BL-1040|2 mL of BL-1040
16312005|NCT00557518|Drug|Alagebrium|200 mg bid
16312006|NCT00557518|Drug|Placebo|bid
16312007|NCT00557505|Drug|PF-03732010|IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.
16312008|NCT00557492|Drug|Avastin (bevacizumab)|10 mg/kg, days 1, 15, 29 and 43
16312009|NCT00557492|Drug|Gemzar (Gemcitabine)|On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
16312010|NCT00557492|Radiation|external beam radiotherapy|3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
16312011|NCT00557466|Drug|indacaterol|Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
16312012|NCT00557466|Drug|formoterol|Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
16312013|NCT00557466|Drug|placebo to indacaterol|Placebo TWISTHALER® device
16312014|NCT00557466|Drug|placebo to formoterol|Placebo AEROLIZER® device
16312015|NCT00557466|Drug|short acting β2- agonist|100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
16312016|NCT00557453|Drug|Antibiotic treatment|Cefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement.
16312017|NCT00557453|Drug|No antibiotics|Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.
16312018|NCT00557440|Drug|fluticasone propionate/salmeterol|Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.
16312019|NCT00557440|Drug|indacaterol maleate / mometasone furoate|Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.
16312020|NCT00557440|Drug|placebo to indacaterol/mometasone|Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.
16312021|NCT00557440|Drug|placebo to fluticasone propionate/salmeterol|Placebo to fluticasone propionate / salmeterol delivered via MDDPI.
16312022|NCT00557427|Drug|hypericum|250mg tablets twice daily for 8 weeks
16312023|NCT00557427|Drug|fluoxetine|20mg - 40mg daily for 8 weeks
16312024|NCT00557401|Drug|XP19986 SR3, 20 mg QD|XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
16312025|NCT00557401|Drug|XP19986 SR3, 40 mg QD|XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
16312026|NCT00557401|Drug|XP19986 SR3, 60 mg QD|XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
16312027|NCT00557401|Drug|XP19986 SR3, 30 mg BID|XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
16312028|NCT00557401|Drug|Placebo|Placebo tablet taken orally for approximately 32 days with titration and taper periods.
16312029|NCT00557388|Dietary Supplement|Protein/Amino Acids|Casein Whey Leucine
16312082|NCT00557076|Behavioral|Sham Auditory Sensory Training|The sham intervention is zero minutes of Familiar Auditory Sensory Training. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence.
16312221|NCT00556075|Drug|Proellex 25 mg|1 capsule daily for 4 months
16312030|NCT00557388|Other|Physical exercise|The physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets.
16312031|NCT00557362|Drug|Natamycin 5%|One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake
16312032|NCT00557362|Drug|Voriconazole|"Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution.
~One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake"
16312033|NCT00557362|Procedure|Corneal de-epithelialization|Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.
16312034|NCT00557349|Drug|Omeprazole|40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
16312035|NCT00557349|Drug|Famotidine|40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
16312036|NCT00557336|Drug|somatropin|
16312037|NCT00557323|Drug|Lanthanum carbonate|
16312038|NCT00557310|Drug|teriparatide|20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
16312039|NCT00557284|Drug|Montelukast|4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
16312040|NCT00557284|Drug|Placebo|Oral granules or chewable tablet, PO QD (given oral daily)
16312041|NCT00557245|Drug|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
16312042|NCT00557245|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
16312043|NCT00557245|Drug|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
16312044|NCT00557232|Drug|bevacizumab|1.25mg/month
16312045|NCT00557219|Drug|fenoldopam (Corlopam)|continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
16312046|NCT00557219|Drug|placebo|continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
16312047|NCT00557219|Drug|ketanserin (Sufrexal)|continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
16312048|NCT00557206|Drug|Oxaliplatin and Docetaxel|"Chemotherapy
~Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days."
16312049|NCT00557193|Drug|Asparaginase|Given IV, IM, or PO
16312050|NCT00557193|Drug|Cyclophosphamide|Given IV
16312051|NCT00557193|Drug|Cytarabine|Given IV or IT
16312052|NCT00557193|Drug|Daunorubicin Hydrochloride|Given IV
16312053|NCT00557193|Drug|Dexamethasone|Given IV or PO
16312054|NCT00557193|Drug|Etoposide|Given IV
16312055|NCT00557193|Biological|Filgrastim|Given IV or SC
16312056|NCT00557193|Other|Laboratory Biomarker Analysis|Correlative studies
16312057|NCT00557193|Drug|Lestaurtinib|Given PO
16312058|NCT00557193|Drug|Leucovorin Calcium|Given IV
16312059|NCT00557193|Drug|Mercaptopurine|Given PO
16312060|NCT00557193|Drug|Methotrexate|Given IV, IT, or PO
16312061|NCT00557193|Drug|Methylprednisolone|Given IV
16312062|NCT00557193|Drug|Pegaspargase|Given IM
16312063|NCT00557193|Other|Pharmacological Study|Correlative studies
16312064|NCT00557193|Drug|Prednisone|Given PO
16312065|NCT00557193|Drug|Therapeutic Hydrocortisone|Given IT
16312066|NCT00557193|Drug|Vincristine Sulfate|Given IV
16312067|NCT00557180|Drug|Beclomethasone dipropionate HFA|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
16312068|NCT00557180|Drug|Tiotropium bromide|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
16312069|NCT00557180|Drug|Salmeterol xinafoate|Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
16312070|NCT00557154|Device|ultrasound|ultrasound used to identify target vein
16312071|NCT00557154|Device|standard technique for venipuncture|routine equipment
16312072|NCT00557128|Drug|COREG CR and lisinopril (FDC)|
16312073|NCT00557115|Other|Early pulmonary rehabilitation (EPR)|Multidisciplinary exercise programme in the format of standard pulmonary rehabilitation. Consists of 2 supervised exercise and educations sessions per week for up to 16 sessions within 3-months. Participants are encouraged to keep an exercise diary at perform at least one exercise session at home unsupervised.
16312074|NCT00557102|Biological|cetuximab|
16312075|NCT00557102|Biological|filgrastim|
16312076|NCT00557102|Drug|fluorouracil|
16312077|NCT00557102|Drug|irinotecan hydrochloride|
16312078|NCT00557102|Drug|leucovorin calcium|
16312079|NCT00557089|Drug|rhDNAse|2.5 mg rhDNase will be dispensed in 2.5 ml vials and administered once a day for 28 days. Treatment will be administered by inhalation.
16312080|NCT00557089|Other|Placebo|2.5 mg of the placebo will be dispensed in 2.5 ml vials and administered once a day over 28 days. Treatment will be administered by inhalation.
16312081|NCT00557076|Behavioral|Familiar Auditory Sensory Training|Patient is provided with customized recordings of stories told by people well known to the patient at least 1 year prior to injury. The stories represent specific events experienced by both the patient and the storyteller. Patients received FAST for 10 minutes 4 times per day, with at least 2 hours in between, for 6 week.
16312083|NCT00557050|Other|Training|10-week eccentric hamstring muscle training
16312084|NCT00557037|Drug|Phenoxodiol|Oral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months
16312085|NCT00557024|Procedure|RFA|radiofrequency ablation
16312086|NCT00557024|Procedure|radiotherapy after RFA|radiotherapy after RFA
16312087|NCT00557011|Drug|NRP104|30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
16312088|NCT00557011|Drug|Adderall XR|10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
16312089|NCT00557011|Drug|Placebo|Placebo capsule taken once daily in the morning
16312090|NCT00556998|Drug|Voriconazole|Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.
16312091|NCT00556972|Device|Fecal Incontinence Management System|The device is intended to remedy fecal incontinence.
16312092|NCT00556959|Drug|high dose clonidine HCl sustained release|high dose clonidine HCl sustained release tablets for 8 weeks
16312093|NCT00556959|Drug|low dose clonidine HCl sustained release|low dose clonidine HCl sustained release tablets for 8 weeks
16312094|NCT00556959|Drug|placebo|placebo tablets for 8 weeks
16312095|NCT00556946|Drug|Combined Photodynamic & Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser
16312096|NCT00556933|Drug|rabbit anti-thymocyte globulin|A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.
16312097|NCT00556933|Drug|mycophenolate mofetil|Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.
16312098|NCT00556933|Drug|rabbit anti-thymocyte globulin|6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.
16312099|NCT00556933|Drug|sirolimus|Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection
16312100|NCT00556933|Drug|tacrolimus|Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.
16312101|NCT00556920|Drug|COREG CR|
16312102|NCT00556907|Radiation|Intraoperative radiotherapy|20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
16312103|NCT00556907|Device|Intraoperative radiotherapy|20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
16312104|NCT00556894|Drug|CF101|orally q12h
16312105|NCT00556894|Drug|Placebo|orally q12h
16312106|NCT00556868|Other|Breakfast/no breakfast|"A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention.
~B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention"
16312107|NCT00556855|Other|E-DO|topical lotion, once daily (evening), total duration: 4 weeks
16312108|NCT00556855|Other|Placebo|topical lotion, once daily (evening), total duration: 4 weeks
16312109|NCT00556842|Device|Total hip arthroplasty|Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
16312110|NCT00556842|Device|Hemi-arthroplasty|Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.
16312111|NCT00556816|Behavioral|on demand clinic|Outpatient on demand clinic
16312112|NCT00556816|Behavioral|Control|conventional outpatient clinic
16312113|NCT00556803|Procedure|radiofrequency ablation|radiofrequency ablation
16312114|NCT00556803|Procedure|TACE after RFA|TACE after RFA within one month
16312115|NCT00556790|Procedure|Standard Care|standard fluid regime, delayed feeding
16312116|NCT00556790|Procedure|Fast Track care|restrictive fluid regime, early oral feeding, enforced mobilisation
16312117|NCT00556777|Procedure|axillary lymph node dissection|
16312118|NCT00556777|Procedure|conventional surgery|
16312119|NCT00556777|Procedure|sentinel lymph node biopsy|
16312120|NCT00556777|Radiation|intraoperative radiation therapy|
16312121|NCT00556764|Drug|[123I] IBVM and SPECT imaging|Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
16312122|NCT00556764|Drug|Subjects will undergo the 123-I IBVM imaging visit|Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.
16312123|NCT00556738|Procedure|Nasal Continuous Positive Airway Pressure ventilation|Nasal Continuous Positive Airway Pressure ventilation
16312124|NCT00556738|Procedure|Intrapulmonary Percussive Ventilation|Intrapulmonary Percussive Ventilation
16312125|NCT00556712|Drug|erlotinib [Tarceva]|150mg po daily
16312126|NCT00556712|Drug|Placebo|po daily
16312127|NCT00556699|Drug|rituximab|Escalating intravenous repeating dose
16312128|NCT00556699|Drug|SGN-40|Escalating intravenous repeating dose
16312129|NCT00556673|Drug|indacaterol maleate/mometasone furoate|Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.
16312130|NCT00556673|Drug|placebo to indacaterol maleate/mometasone furoate|Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
16312131|NCT00556673|Drug|fluticasone proprionate / salmeterol xinafoate|Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.
16312132|NCT00556660|Drug|[123I] AV-151|To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
16312133|NCT00556647|Procedure|fast track diagnosis|fast-track diagnosis, PET-CT, bronchoscopy
16312134|NCT00556647|Procedure|conventional diagnosis|out-patient diagnosis
16312135|NCT00556634|Drug|Efavirenz|"Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward)
~OR
~Efavirenz usual dosage (600 mg/day from the first day)"
16312136|NCT00556621|Drug|cisplatin|
16312137|NCT00556621|Drug|gemcitabine hydrochloride|
16312138|NCT00556621|Procedure|biopsy|
16312139|NCT00556621|Procedure|cystoscopy|
16312140|NCT00556621|Procedure|therapeutic conventional surgery|
16312141|NCT00556621|Radiation|radiation therapy|
16312142|NCT00556608|Device|Sinovial® (syringe containing sodium hyaluronate solution)|2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
16312143|NCT00556608|Device|Synvisc® ( syringe containing Hylan G-F 20 solution)|2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
16312144|NCT00556595|Procedure|primary electrophysiological approach|primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
16312145|NCT00556595|Procedure|primary anatomical approach|primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps
16312146|NCT00556569|Other|CHAM JAM|"CHAM JAM (previously known as Moving Smart (MS) program) is a daily, 10-minute classroom-based physical activity program led by teachers that integrates academic objectives with physical activity"
16312147|NCT00556543|Device|U-plate fracture repair system|All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery.
16312148|NCT00556504|Drug|TCM-700C|An add-on drug to conventional treatment of Hepatitis C
16312149|NCT00556504|Drug|Peginterferon alfa-2a|conventional treatment of Hepatitis C
16312150|NCT00556504|Drug|Ribavirin|conventional treatment of Hepatitis C
16312151|NCT00556504|Drug|Placebo|Placebo, without acting ingredient.
16312152|NCT00556491|Drug|minocycline|given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
16312153|NCT00556491|Drug|placebo|placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
16312154|NCT00556478|Drug|PSD502, contains a mixture of lidocaine and prilocaine|"PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
16312155|NCT00556478|Drug|Placebo|"The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
16312156|NCT00556465|Drug|N-acetylcysteine|600 mg of effervescent N-acetylcysteine tablet twice per day for three months
16312157|NCT00556452|Drug|Clofarabine/Busulfan x 4|"Clofarabine IV (dose levels)
~1st dose level: 20 mg/m2/day x 5 days
~2nd dose level: 30 mg/m2/day x 5 days
~3rd dose level: 40 mg/m2/day x 5 days
~Busulfan IV 3.2 mg/kg daily x 4 days"
16312158|NCT00556452|Procedure|Peripheral blood stem cell transplant|Peripheral blood stem cell transplant, after pre-conditioning drug treatment
16312159|NCT00556452|Radiation|Total Lymphoid Irradiation|Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant
16312160|NCT00556439|Drug|Abatacept|"Participants will receive a fixed dose of abatacept, approximating 10mg per kilogram of body weight. The following dosing rules will be followed:
~Participants weighing less than 60kg will receive 500mg of abatacept.
~Participants weighing 60 to 100kg will receive 750mg of abatacept.
~Participants weighing more than 100kg will receive 1000mg of abatacept.
~Abatacept will be administered in a 30-minute intravenous infusion on Days 1, 15, 29 (Month 1) and at Month 2. In the absence of toxicity or relapse, participants will remain on abatacept at the same dosage until randomization at Month 3. After randomization, only Group A (giant cell arteritis) and Group C (Takayasu arteritis) participants will continue on abatacept."
16312161|NCT00556439|Drug|Placebo|Placebo abatacept infusions will be given monthly after random assignment at Month 3.
16312162|NCT00556426|Device|Bard Recovery G2 Filter System|Retrieval of previously placed RECOVERY G2 IVC filter
16312163|NCT00556413|Biological|cetuximab|
16312164|NCT00556413|Drug|fluorouracil|
16312165|NCT00556413|Drug|irinotecan hydrochloride|
16312166|NCT00556413|Drug|leucovorin calcium|
16312167|NCT00556413|Drug|oxaliplatin|
16312168|NCT00556400|Drug|Lo-Ovral Oral Contraceptive Pills|
16312169|NCT00556400|Drug|Placebo - sugar pill|
16312170|NCT00556387|Drug|saline|1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
16312171|NCT00556387|Drug|Ketamine|1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)
16312172|NCT00556374|Drug|Placebo|
16312173|NCT00556374|Biological|Denosumab|Administered as a subcutaneous injection
16312174|NCT00556374|Drug|Non-steroidal aromatase inhibitor therapy|An approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting
16312175|NCT00556374|Drug|Zoledronic Acid|5 mg zoledronic acid administered at a constant infusion rate
16312176|NCT00556374|Other|Standard of Care|Standard of care (SoC) as recommended by the treating physician, depending on individual factors such as bone density, lifestyle recommendations by the Investigator such as diet, physical activities and sun exposure, as well as local treatment standards.
16312177|NCT00556361|Drug|saline|2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
16312178|NCT00556361|Drug|ketamine|2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
16312179|NCT00556348|Drug|bevacizumab|1.25mg
16312180|NCT00556335|Procedure|manual aspiration|air aspiration
16312181|NCT00556335|Procedure|conventional drainage|drainage, pneumocath
16312182|NCT00556322|Drug|Alimta or Taxotere|500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
16312183|NCT00556322|Drug|erlotinib [Tarceva]|150mg po daily
16312184|NCT00556309|Device|Optical Coherence Tomography|Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
16312185|NCT00556296|Drug|NRP104|NRP104 30mg capsule once daily in a.m.
16312186|NCT00556296|Drug|NRP104|NRP104 50mg capsule once daily in a.m.
16312187|NCT00556296|Drug|NRp104|NRP104 70mg capsule once daily in a.m.
16312188|NCT00556296|Drug|Placebo|Placebo
16312189|NCT00556283|Device|STARR|Stapled Trans-Anal Rectal Resection for the treatment of ODS
16312190|NCT00556283|Behavioral|Biofeedback|electromyographic-based treatment sessions
16312191|NCT00556270|Drug|Matrifen|as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)
16312192|NCT00556257|Drug|Cyclosporine|Standard of care
16312193|NCT00556257|Drug|CP-690-,550|CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12
16312194|NCT00556244|Procedure|ILM peeling|ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.
16312195|NCT00556218|Behavioral|Tibetan Meditation Program|12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.
16312196|NCT00556218|Behavioral|No Meditation|No meditation; usual care.
16312197|NCT00556205|Drug|Sunitinib|Sunitinib orally once daily
16312198|NCT00556205|Drug|Bevacizumab|Intravenously every 14 days
16312199|NCT00556192|Drug|rituximab|"Rituximab of 1000 mg given 2 weeks apart. On day the of rituximab, and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5.
~A treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14.
~Sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. Oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period."
16312200|NCT00556179|Drug|Lactoserum (Dermacyd Femina®)|Once a day during three months
16312201|NCT00556166|Device|Enterra Therapy Gastric Stimulator|"The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2 x 2 x 1/2 and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.
~The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control."
16312202|NCT00556153|Drug|[F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical|A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent.
16312203|NCT00556140|Drug|Aripiprazole|"Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study.
~Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
~You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day."
16312204|NCT00556127|Drug|Rituximab|375 mg/m2 on day 1
16312205|NCT00556127|Drug|Epirubicin|110 mg/m2 on day 3
16312206|NCT00556127|Drug|Cyclophosphamide|1200 mg/m2 on day 3
16312207|NCT00556127|Drug|Vincristine|1.4 mg/m2 (maximum 2 mg) on day 3
16312208|NCT00556127|Drug|Prednisone|40 mg/m2 from day 1 to 5
16312209|NCT00556127|Drug|Granulocyte-colony-stimulating factor|(G-CSF 5 μg/Kg/day) from day 5 to day 11
16312210|NCT00556127|Drug|Mitoxantrone|8 mg/m2 for 3-day
16312211|NCT00556127|Drug|Cytarabine ARA-C|2 g/m2/12 hours for six doses in 3-hour infusion
16312212|NCT00556127|Drug|Dexamethasone|4 mg/m2/12 hours before ARA-C administration
16312213|NCT00556127|Drug|Carmustine BCNU|300 mg/m2 on day -7
16312214|NCT00556127|Drug|Etoposide|100 mg/m2/12 hours
16312215|NCT00556127|Drug|Melphalan|140 mg/m2 on day -2
16312216|NCT00556127|Radiation|Radiotherapy|Involved Field Radiotherapy (IF-RT)
16312217|NCT00556127|Procedure|PBSC reinfusion|ASCT
16312218|NCT00556114|Device|Optical Coherence Tomography|Optical Coherence Tomography
16312219|NCT00556101|Procedure|Whole body magnetic resonance angiography|
16312220|NCT00556088|Drug|LBH589, Paclitaxel, Carboplatin, Bevacizumab|"LBH589 will be administered orally twice weekly. Paclitaxel and carboplatin will be administered intravenously every 21 days.
~Once the MTD is established, drug dosages will be adjusted downward by one dose level and bevacizumab 15mg/kg intravenously every 3 weeks will be administered to a subset of patients with non-small cell lung cancer."
16312222|NCT00556075|Drug|Placebo|1 capsule daily for 4 months
16312223|NCT00556075|Drug|Proellex 50 mg|2 capsules daily for 4 months
16312224|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
16312225|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
16312226|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
16312227|NCT00556062|Biological|seasonal split influenza vaccine|0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
16312228|NCT00556049|Drug|Gemcitabine|Intravenously on days 1 and 8 of each 21-day treatment cycle.
16312229|NCT00556049|Drug|Sunitinib|Orally on days 1-14 of each 21-day treatment cycle
16312230|NCT00556023|Drug|CP-675,206 and gemcitabine|Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
16312231|NCT00555997|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
16312232|NCT00555997|Drug|Ziprasidone|20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
16312233|NCT00555997|Drug|Placebo|"0mg Placebo per day. Dose increases and dose decreases may occur, but patient will remain at 0mg placebo"
16312234|NCT00555984|Drug|Propofol + Remifentanil|Administered intravenously during surgery for maintenance of General Anesthesia
16312235|NCT00555984|Drug|Sevoflurane + Remifentanil|the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
16312236|NCT00555971|Drug|Omalizumab|Subjects randomized to Omalizumab prior to aspirin desensitization
16312237|NCT00555971|Drug|placebo|Subjects randomized to Placebo prior to aspirin desensitization
16312238|NCT00555958|Device|Active, implantable, intra-abdominal vagal blocking medical device|Intermittent, programmable, intra-abdominal vagal blocking
16312239|NCT00555945|Procedure|Gamma3 intramedullary nail (Stryker)|The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
16312240|NCT00555945|Procedure|Sliding Hip Screw|The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
16312241|NCT00555932|Procedure|Ultrasound|All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.
16312242|NCT00555919|Drug|Lonaprisan (ZK 230211, BAY86-5044)|25 mg daily oral treatment
16312243|NCT00555919|Drug|Lonaprisan (ZK 230211, BAY86-5044)|100 mg daily oral treatment
16312244|NCT00555906|Drug|Bortezomib|Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
16312245|NCT00555906|Drug|Dexamethasone|20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
16312246|NCT00555906|Drug|PD 0332991|Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
16312247|NCT00555893|Drug|Oseltamivir|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:
~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
16312248|NCT00555893|Drug|Placebo|Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.
16312249|NCT00555880|Drug|Midodrine hydrochloride|one dose, 10-30mg, given orally
16312250|NCT00555880|Drug|Placebo|Placebo
16312251|NCT00555867|Drug|Anastrozole|oral
16312252|NCT00555854|Behavioral|An individual motivational intervention program to promote and maintain self-care behaviour|5 individual interviews in an one year period
16312253|NCT00555841|Drug|ALC and Placebo|ALC and Placebo
16312254|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|25 M allogeneic MPCs by transendocardial injection
16312255|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
16312256|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|75 M allogeneic MPCs by transendocardial injection
16312257|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
16312258|NCT00555828|Genetic|Allogeneic Mesenchymal Precursor Cells (MPCs)|150 M allogeneic MPCs by transendocardial injection
16312259|NCT00555828|Procedure|Standard-of-care treatment with NOGA® mapping and staged injections.|Standard-of-care treatment with NOGA® mapping and staged injections.
16312260|NCT00555802|Other|exercise|exercise
16312261|NCT00555789|Drug|AEB071|200mg oral b.i.d.
16312262|NCT00555789|Drug|mycophenolic plus tacrolimus|720mg b.i.d. 2yrs
16312263|NCT00555776|Drug|Gabapentin|Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary.
16312264|NCT00555776|Drug|placebo|placebo is given with the same definition as Gabapentin
16312265|NCT00555763|Device|Tonometry|Tonometry : measurement of intraocular pressure with an applanation tonometer
16312266|NCT00555750|Drug|eszopiclone|3mg tablet, by mouth nightly 30 min before bed, for two months
16312267|NCT00555750|Drug|placebo|inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months
16312268|NCT00555737|Device|Capsule Endoscopy|Given® Diagnostic system with Pillcam SB
16312269|NCT00555724|Drug|BIIB022|IV infusion once every three weeks until disease progression or unacceptable toxicity
16312270|NCT00555711|Device|Modulated Imaging|Modulated Imaging
16312271|NCT00555698|Device|Deep Brain Stimulations for Depression|Deep Brain Stimulations for Depression
16312272|NCT00555685|Drug|NaCl 7,5% (Hypertonic Saline Solution)|Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
16312273|NCT00555685|Drug|NaCl 0,9%|Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days
16312274|NCT00555672|Drug|5-fluorouracil|5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16312275|NCT00555672|Drug|cisplatin|Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16312276|NCT00555672|Drug|sunitinib malate|sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16312277|NCT00555646|Drug|PH-10 (rose bengal disodium 0.001%)|"PH-10 with 544 nm LED light illumination
~OR
~PH-10 with ambient light exposure"
16312278|NCT00555646|Drug|Control|No treatment control.
16312279|NCT00555620|Drug|capecitabine|Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
16312280|NCT00555620|Drug|oxaliplatin|Oxaliplatin is given 110mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16312281|NCT00555620|Drug|sunitinib malate|sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
16312282|NCT00555620|Drug|capecitabine|Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.
16312283|NCT00555620|Drug|cisplatin|Cisplatin is given 80mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
16312284|NCT00555620|Drug|sunitinib malate|sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
16312285|NCT00555607|Drug|prednisolone|Prednisolone oral tablets (10 mg active ingredient per tablet) once a day at a dose of 0.5mg/kg bodyweight, during 14 days.
16312286|NCT00555594|Drug|Bevacizumab (Avastin)|One dose of 0.1cc of subconjunctival Bevacizumab was applied
16312287|NCT00555581|Drug|Imatinib Mesylate|In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months.
16312288|NCT00555568|Behavioral|recovery oriented mental health peer support group|This is a recovery-focused mental health education and support group led by peer facilitators
16312289|NCT00555568|Behavioral|recovery-oriented mental health clinician-led group|This is a recovery-focused mental health education and support group led by a mental health clinician
16312290|NCT00555555|Biological|Alphanate SD/HT|A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded.
16312291|NCT00555542|Drug|rituximab|Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
16312292|NCT00555529|Procedure|radial artery applanation tonometry (RAAP)|non-invasive tonometry
16312293|NCT00555516|Other|EW02|"Name: EW02
~Dosage form: capsule.
~Dose(s): 350mg per capsule, 2 capsule tid.
~Dosing schedule: 2 capsule tid; 15 days (D3 to D17) of EW02 or placebo in Cycles 2 and 3."
16312294|NCT00555490|Dietary Supplement|Soy protein|35 % of protein from soy protein for 4-years
16312295|NCT00555477|Drug|anastrozole|1 mg tablet by mouth once a day
16312296|NCT00555464|Drug|Vincristine|Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI.
16312297|NCT00555464|Drug|Prednisone|Prednisolone given at 3 mg/kg/day by mouth for 12 week
16312298|NCT00555451|Drug|HE3286|"Dose escalating cohort driven study. 6 planned cohorts.
~HE3286 5 mg or placebo QD for 28 days;
~HE3286 10 mg (5 mg BID) or placebo BID for 28 days
~HE3286 20 mg (10 mg BID) or placebo BID for 28 days
~HE3286 40 mg (20 mg BID) or placebo BID for 28 days
~HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
~HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)"
16312299|NCT00555438|Drug|fondaparinux 1.5 mg/day|Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery
16312300|NCT00555425|Behavioral|Behavioral: Buprenorphine/naloxone maintenance (Mtn)|Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
16312435|NCT00554541|Other|Ankle Brachial Index Venous physiologic study|Assessment of lower extremity venous disease
16312301|NCT00555425|Behavioral|Behavioral: Buprenorphine/naloxone detoxification (Dtx)|Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.
16312302|NCT00555412|Drug|A - 10 mg loxapine q 4 h x 3 (30 mg total)|loxapine aerosol inhalation high dose regimen (30 mg total)
16312303|NCT00555412|Drug|B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)|loxapine aerosol inhalation middle dose regimen (20 mg total)
16312304|NCT00555412|Drug|C - 5 mg loxapine q 4 h x 3 (15 mg total)|loxapine aerosol inhalation low dose regimen (15 mg total)
16312305|NCT00555412|Drug|D - inhaled placebo q 4 h x 3|placebo aerosol inhalation (0 mg total)
16312306|NCT00555399|Drug|Vorinostat|"Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days.
~Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days."
16312307|NCT00555399|Drug|Isotretinoin|"Phase I/Arm 1: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days.
~Phase I/Arm 2: Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days.
~Phase I/Arm 3: Level -II = 100 mg/m^2/day PO x 21 days; Level -I = 100 mg/m^2/day PO x 21 days; Level 0 = 100 mg/m^2/day PO x 21 days; Level I = 100 mg/m^2/day PO x 21 days; Level II = 100 mg/m^2/day PO x 21 days."
16312308|NCT00555399|Procedure|Surgical Resection|Surgical Resection for recurrent Glioblastoma Multiforme
16312309|NCT00555399|Drug|Temozolomide|"Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days.
~Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days."
16312310|NCT00555386|Dietary Supplement|Soy and Selenium|6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
16312311|NCT00555373|Drug|Sirolimus|"Tacrolimus (Prograf®) At 6 months post-transplantation, patients will have Prograf® tapered by 25% per week such that they will be off of this medication by 7 months post-transplantation.
~Sirolimus (Rapamune®):
~At 6 months post-transplantation, all patients will be administered Sirolimus at a dose of 1.65-2.79 mg/m2/day as a tablet or liquid (administered q 12 hours)."
16312312|NCT00555360|Behavioral|HITCM+CP|Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.
16312313|NCT00555360|Behavioral|HITCM only|Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.
16312314|NCT00555347|Drug|Armodafinil|Dosage 150-250 mg
16312315|NCT00555347|Drug|Placebo|Placebo
16312316|NCT00555334|Procedure|RFA|radiofrequency ablation
16312317|NCT00555334|Drug|lamivudine or entecavir|lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA
16312318|NCT00555321|Drug|Tacrolimus|Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (Long-Term Extension [LTE])
16312319|NCT00555321|Drug|Basiliximab|Intravenous (IV), 20 mg, Day1 and Day 5
16312320|NCT00555321|Drug|Belatacept More Intensive (MI)|"Intravenous (IV),
~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.
~After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE])"
16312321|NCT00555321|Drug|Belatacept Less Intensive (LI)|"Intravenous (IV),
~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.
~After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)"
16312322|NCT00555321|Drug|Mycophenolate Mofetil (MMF)|Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
16312323|NCT00555308|Other|emergency department targeted ultrasound imaging|bedside ultrasound performed by emergency physician to identify hydronephrosis
16312324|NCT00555282|Device|central venous catheter|coated central venous catheter
16312325|NCT00555282|Device|central venous catheter|standard central venous catheter
16312326|NCT00555256|Drug|sunitinib and rapamycin (Drug will be held)|Any toxicity causing a total of 14 days delay of therapy will be considered dose limiting.
16312327|NCT00555243|Procedure|Laparoscopic Simulation training|five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
16312328|NCT00555243|Procedure|Traditional Surgical Education|Traditional surgical teaching (no simulator)
16312329|NCT00555230|Drug|Rosuvastatin|5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
16312330|NCT00555230|Drug|Placebo|5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
16312331|NCT00555217|Drug|losartan|50 or 100mg/day
16312332|NCT00555217|Drug|lisinopril|10, 20 or 40 mg/day
16312333|NCT00555204|Drug|ABT-089|10 mg - capsules once daily for 12 weeks
16312334|NCT00555204|Drug|ABT-089|5 mg - capsules once daily for 12 weeks
16312335|NCT00555204|Drug|ABT-089|15 mg - capsules once daily for 12 weeks
16312336|NCT00555204|Drug|ABT-089|20 mg - capsules once daily for 12 weeks
16312337|NCT00555204|Drug|ABT-089|30 mg - capsules once daily for 12 weeks
16312338|NCT00555204|Drug|ABT-089|35 mg - capsules once daily for 12 weeks
16312339|NCT00555204|Drug|placebo|placebo - capsules once daily for 12 weeks
16312340|NCT00555191|Behavioral|diet restriction|each meal should contain less than 2 gm fructose
16312341|NCT00555165|Device|Telescope prosthesis|Monocular implantation of the telescope prosthesis after cataract extraction
16312342|NCT00555152|Other|Laboratory Biomarker Analysis|Correlative studies
16312343|NCT00555152|Drug|Lapatinib Ditosylate|Given PO
16312344|NCT00555152|Other|Placebo|Given PO
16312345|NCT00555139|Drug|GSK561679 tablet|GSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A.
16312346|NCT00555139|Drug|GW876008 tablet|GW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base).
16312477|NCT00554177|Drug|Placebo|2 doses of 1200mg, administered 2-3 days apart
16312347|NCT00555139|Drug|alprazolam|Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).
16312348|NCT00555139|Drug|Placebo|GW876008 placebo tablets will visually match the active GW876008 tablets. GSK561679 placebo tablets will visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that will visually match the active but containing only a filler.
16312349|NCT00555126|Device|Forced Air Warming|Warming after Randomization
16312350|NCT00555126|Device|Warming with endovascular catheter + forced air warming|Warming after Randomization
16312351|NCT00555100|Drug|lenalidomide|10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
16312352|NCT00555100|Drug|dexamethasone|40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
16312353|NCT00555087|Drug|Testosterone Undecanoate and/or PDE-5|Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
16312354|NCT00555074|Drug|Sodium Tungstate|Sodium Tungstate, 200 mg BID, oral route during 6 weeks
16312355|NCT00555074|Drug|Placebo|Placebo, BID, oral route during 6 weeks
16312356|NCT00555061|Drug|Retapamulin Ointment, 1%|1% Ointment
16312357|NCT00555048|Biological|alemtuzumab|
16312358|NCT00555048|Drug|busulfan|
16312359|NCT00555048|Drug|cyclophosphamide|
16312360|NCT00555048|Drug|methotrexate|
16312361|NCT00555048|Drug|tacrolimus|
16312362|NCT00555048|Procedure|allogeneic hematopoietic stem cell transplantation|
16312363|NCT00555048|Procedure|peripheral blood stem cell transplantation|
16312364|NCT00555035|Drug|GSK1349572|
16312365|NCT00555022|Drug|GSK1160724|GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.
16312366|NCT00555022|Drug|Tiotropium bromide|Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.
16312367|NCT00555022|Drug|Placebo|Subjects will receive placebo.
16312368|NCT00555009|Drug|Genotropin|Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
16312369|NCT00555009|Drug|Placebo|Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
16312370|NCT00554996|Device|E. coli 83972 coated urinary catheter|E. coli 83972 coated urinary catheter
16312371|NCT00554983|Biological|recombinant birch pollen allergen|subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
16312372|NCT00554983|Biological|placebo|subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
16312373|NCT00554970|Drug|MAP0010 low dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
16312374|NCT00554970|Drug|MAP0010 high dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
16312375|NCT00554970|Drug|Budesonide inhalation suspension 0.25mg|a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
16312376|NCT00554970|Drug|Budesonide inhalation suspension 0.5mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
16312377|NCT00554944|Procedure|Esophageal probe|Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe
16312378|NCT00554918|Drug|docetaxel|
16312379|NCT00554918|Drug|prednisolone|
16312380|NCT00554918|Drug|zoledronic acid|
16312381|NCT00554918|Procedure|quality-of-life assessment|
16312382|NCT00554918|Radiation|strontium chloride Sr 89|
16312383|NCT00554905|Procedure|Radiofrequency ablation|For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, California, USA) and a needle electrode with a 15-gauge insulated cannula with 10 hook-shape expandable electrode tines with a diameter of 3.5cm at expansion (LeVeen; RadioTherapeutics, Mountain View, California, USA).
16312384|NCT00554905|Procedure|TACE|TACE first, then RFA within 2 weeks
16312385|NCT00554892|Procedure|bowel preparation|oral laxatives, retrograde enemas
16312386|NCT00554892|Procedure|no preparation bowel|no preparation bowel
16312387|NCT00554879|Procedure|Acupuncture|Needles placed bilaterally on the ears at the auriculotherapy points. Additional needles placed in both index fingers. A third set of needles inserted on both index fingers between LI-1 adn LI-2.
16312388|NCT00554879|Procedure|Sham acupuncture|Four needles will be placed on the left and right upper shoulder areas. Small circular adhesive tape will be placed in an ear area, but not on the acupuncture points.
16312389|NCT00554866|Other|blood sample and buccal swab sample|"one blood sample (500 mL) will be obtained from each VLBW infant between 6 and12 hours after birth from an umbilical-artery or peripheral artery catheter.
~Additional DNA collection buccal cell samples were obtained with a sterile OmniSwab."
16312390|NCT00554853|Drug|pioglitazone|daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily
16312391|NCT00554853|Drug|Sublingual nitroglycerine|Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed.
16312392|NCT00554840|Drug|varenicline|Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
16312393|NCT00554840|Drug|placebo|At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
16312520|NCT00553800|Drug|Erlotinib|
16312643|NCT00553124|Procedure|medical chart review|
16312394|NCT00554827|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
~Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
16312395|NCT00554827|Dietary Supplement|Folic Acid|"1 mg orally
~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
~Administered daily throughout the study and for at least 30 days after last dose of pralatrexate."
16312396|NCT00554827|Drug|Pralatrexate|Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or
16312397|NCT00554814|Drug|Bledilait Biofer®|Bledilait Biofer® 2 mg/100 kcal
16312398|NCT00554814|Drug|Milk supplemented with ferrous sulphate|Milk supplemented with ferrous sulphate (2mg/100kcal)
16312399|NCT00554814|Drug|Blédilait Biofer®|Blédilait Biofer® milk (1,1mg/100kcal)
16312400|NCT00554801|Procedure|Audiological testing|Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.
16312401|NCT00554788|Procedure|Autologous Bone Marrow Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
16312402|NCT00554788|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
16312403|NCT00554788|Drug|Carboplatin|Given IV
16312404|NCT00554788|Drug|Cisplatin|Given IV
16312405|NCT00554788|Drug|Cyclophosphamide|Given IV
16312406|NCT00554788|Drug|Etoposide|Given IV
16312407|NCT00554788|Biological|Filgrastim|Given SC
16312408|NCT00554788|Procedure|In Vitro-Treated Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell or bone marrow transplant
16312409|NCT00554788|Radiation|Radiation Therapy|Undergo radiotherapy
16312410|NCT00554788|Drug|Thiotepa|Given IV
16312411|NCT00554788|Drug|Vincristine Sulfate|Given IV
16312412|NCT00554775|Drug|erlotinib hydrochloride|PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
16312413|NCT00554775|Drug|placebo|WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride
16312414|NCT00554762|Drug|GW842166X|Administer
16312415|NCT00554749|Behavioral|Interventions at home, in the kindergarten/school|Weekly interventions including behavior techniques (stimulus fading)
16312416|NCT00554736|Biological|Lactobacillus acidophilus L-92|Nasal challenge and acoustic rhinometry will be performed at the first study visit and again at the end of the 4-month supplement period. Standardized perennial ryegrass pollen extract (Lolium perenne) (Hollister-Stier, Inc., Spokane, WA) will be used. Dilutions of the standard product will be made in sterile saline prior to use. The standard product strength is 100,000 BAU/mL. Provocation will start with 100 BAU/mL, delivered as a 100 microliter puff into each nostril nose during breath holding, followed by expiration. Acoustic rhinometry, performed in each nostril, will be recorded at 15 minutes. A change of 30% from baseline in the composite score is considered significant. The dose will be increased every 20 minutes if there is no response. The concentrations used will be 100 BAU, 330 BAU, 1000 BAU, 3300 BAU, 10,000 BAU or 33,000 BAU/mL.
16312417|NCT00554723|Drug|NeuroAid|4 capsules 3 times daily, for three months
16312418|NCT00554723|Drug|NeuroAid matched Placebo|NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
16312419|NCT00554710|Drug|infliximab+azathioprine|infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg
16312420|NCT00554710|Drug|methylprednisolone or budesonide|methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper
16312421|NCT00554671|Other|Algorithm driven medication titration|Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
16312422|NCT00554671|Behavioral|Monitoring|Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
16312423|NCT00554671|Behavioral|Group support|Peer support are provided in the group setting
16312424|NCT00554671|Behavioral|Self efficacy|Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision
16312425|NCT00554658|Drug|Quetiapine|Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.
16312426|NCT00554645|Behavioral|multi-disciplinary group intervention|children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months
16312427|NCT00554645|Other|traditional information|1 session of nutritional advise for parents and child and 1 follow-up after one month
16312428|NCT00554632|Drug|Ethinyl estradiol and norgestimate|Oral contraceptive
16312429|NCT00554632|Drug|Ethinyl estradiol and norelgestromin|Transdermal hormonal contraceptive changed weekly
16312430|NCT00554619|Drug|GSK1325760A|2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.
16312431|NCT00554606|Drug|Canakinumab|Canakinumab
16312432|NCT00554580|Procedure|Continuous Positive Airway Pressure (CPAP)|"Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy:
~stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status."
16312433|NCT00554580|Procedure|usual care of acute pulmonary oedema|"Usual treatment of acute pulmonary oedema including :
~Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg.
~Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes.
~As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min."
16312434|NCT00554567|Behavioral|HIV Testing and Care Services|Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
16312436|NCT00554528|Device|cervical disc prosthesis with a mobile insert named Mobi-C|"Stage 1: partial discectomy
~stage 2: location of the medial axis
~stage 3: centering pin
~stage 4: installation of the caspar spacer
~stage 5: total discectomy
~stage 6: parallel distraction
~stage 7: depth measurement
~stage 8: trial implant
~stage 9: assembly
~stage 10: implant insertion
~stage 11: anchorage optimization"
16312437|NCT00554528|Procedure|arthrodesis - cervical disk surgery|discectomy and arthrodesis
16312438|NCT00554515|Drug|HD IL2|
16312439|NCT00554502|Drug|supportive therapy with: ACE-inhibitor / ARB / Statin|"Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines).
~ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated)
~Other antihypertensive medications depending on the clinical decision and following current guidelines.
~Statin therapy
~Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day."
16312440|NCT00554502|Drug|supportive and immunosuppressive therapy|"supportive therapy as outlined above
~depending on GFR:
~methylprednisolone and prednisolone
~cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone
~Concomitant medication with the immunosuppressive treatment following current clinical practice"
16312441|NCT00554489|Behavioral|exercise intervention|participation in physical activity intervention program weeks 2 through 5
16312442|NCT00554476|Drug|Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting|
16312443|NCT00554463|Drug|Filgrastim|5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.
16312444|NCT00554463|Drug|Pegfilgrastim|6 mg via subcutaneous injection days 46 and 67
16312445|NCT00554463|Drug|Etoposide|Concurrent: 120 mg/m^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m^2, IV on days 43-45 and days 65-66.
16312446|NCT00554463|Drug|Cisplatin|Concurrent: 60 mg/m^2, IV on days 1 and 22. Adjuvant: 60 mg/m^2, IV on days 43 and 64.
16312447|NCT00554463|Radiation|radiation therapy|A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.
16312448|NCT00554450|Drug|Dapagliflozin|Tablets, Oral, once daily
16312449|NCT00554437|Behavioral|UW Falls Prevention Program|The intervention model is of a community-based multifactorial intervention that links participants to existing medical care and service networks. The intervention used an algorithm based on the University of Wisconsin Falls Prevention Clinic, designed to identify predisposing factors for falls; induce risk reduction changes in medical conditions, medications, behavior, physical status, and home environment through recommendations to participants and their physicians; and make sure these changes are long-lasting through follow-up and linkages to other care networks.
16312450|NCT00554424|Drug|lignocaine|20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary
16312451|NCT00554424|Drug|normal saline|20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary
16312452|NCT00554398|Drug|MK-0518 400mg twice a day|Raltegravir, MK-0518
16312453|NCT00554385|Drug|ABT-089|Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
16312454|NCT00554372|Genetic|JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)|Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29.
16312455|NCT00554359|Drug|I5NP (a small interfering RNA)|Single IV injection of experimental drug
16312456|NCT00554359|Drug|placebo|Single IV injection of saline
16312457|NCT00554346|Drug|Arcoxia(etoricoxib 90 mg/tablet)|Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days
16312458|NCT00554333|Biological|Flu-ID 15μg|Inactivated Split-Virion Influenza Vaccine for Intradermal Route
16312459|NCT00554333|Biological|Inactivated adjuvanted Influenza Vaccine|Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
16312460|NCT00554320|Procedure|tDCS|During each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.
16312461|NCT00554320|Procedure|tDCS|For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
16312462|NCT00554307|Device|INVOS Cerebral/Somatic oximeter|Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.
16312463|NCT00554294|Behavioral|environmental and behavioral change|In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
16312464|NCT00554281|Device|Use of glucose sensor (Paradigm Guardian)|Use glucose sensor to prevent episodes of severe hypoglycemia
16312465|NCT00554268|Drug|PBI-05204|Starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle
16312466|NCT00554255|Drug|SB751689|
16312467|NCT00554242|Dietary Supplement|Grape seed extract and ascorbic acid|Grape seed extract 450 mg and ascorbic acid 1500 mg daily
16312468|NCT00554229|Drug|ZD4054|ZD4054 10 mg oral tablet once daily
16312469|NCT00554229|Drug|Placebo|Matching placebo oral tablet once daily
16312470|NCT00554216|Drug|VI-0521|3.75 mg phentermine/23 mg topiramate
16312471|NCT00554216|Drug|VI-0521|15 mg phentermine/92 mg topiramate
16312472|NCT00554216|Drug|Placebo matched phentermine/topiramate|Placebo matched phentermine/topiramate
16312473|NCT00554203|Drug|Sulfasalazine|sulfasalazine 2 grams daily for 6 weeks
16312474|NCT00554190|Device|AdvaCoat sinus gel|A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body
16312475|NCT00554190|Device|Merogel Injectable|Bioresorbable hyaluronic acid product
16312476|NCT00554177|Drug|Medicane (mifepristone)|2 doses of 1200mg, Administered 2-3 days apart
16312641|NCT00553124|Procedure|immunohistochemistry staining method|
16312478|NCT00554164|Drug|(R-)CHOP protocol|Patients with a persistently positive interim-PET scan assigned to arm B1 will receive another six cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone).
16312479|NCT00554164|Drug|B-ALL protocol|Patients with a persistently positive interim-PET scan assigned to arm B2 will receive six blocks of the B-ALL protocol (rituximab, methotrexate, ifosfamide, etoposide, cytarabine, vincristine, cyclophosphamide, doxorubicine, vindesine, dexamethasone).
16312480|NCT00554164|Drug|(R-)CHOP protocol|Patients with a negative interim-PET scan assigned to arm A1 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone). Arm A1 was closed when the number of patients required for the randomisation between arms A1 and A2 was reached.
16312481|NCT00554164|Drug|(R-)CHOP protocol|Patients with a negative interim-PET scan assigned to arm A2 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) plus two additional doses rituximab. Since the number of patients required for the randomisation between arms A1 and A2 has been reached, all patients with a negative interim-PET scan are treated according to arm A2.
16312482|NCT00554151|Device|Adjustable Annuloplasty Ring|The investigational device is intended for use in the treatment of mitral valve regurgitation.
16312483|NCT00554138|Drug|placebo|1 dd for 7-10 days
16312484|NCT00554138|Drug|rosuvastatin|1 dd 20 mg for 7-10 days
16312485|NCT00554125|Drug|sirolimus|given at an initial dose of 3 mg/m2, and adjusted over time to achieve steady-state whole-blood trough levels of approximately 5-8 ng/mL
16312486|NCT00554112|Behavioral|Exercise|Exercise
16312487|NCT00554099|Drug|Mesalamine|6 - 400 mg tablets once daily
16312488|NCT00554099|Drug|Probiotic|Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
16312489|NCT00554099|Drug|Placebo|6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
16312490|NCT00554099|Other|Dietary Advice|Dietary advice
16312491|NCT00554099|Drug|Antibiotic for Diverticulitis|Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
16312492|NCT00554086|Drug|Escalating dose of Casodex from 50mg daily to 150 mg daily|Casodex dosage increase from 50mg to 150mg daily until baseline serum PSA is reduced by 50%
16312493|NCT00554047|Other|Multidisciplinary Memory Clinic|Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)
16312494|NCT00554047|Other|General Practitioners|Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners
16312495|NCT00554034|Drug|periopatch|Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
16312496|NCT00554008|Procedure|laparoscopic appendectomy|appendix removal via scope
16312497|NCT00554008|Procedure|open appendectomy|open operation for removal of appendix
16312498|NCT00553995|Drug|salsalate|Salsalate 3-4 grams per day as tolerated for nine days
16312499|NCT00553995|Drug|Placebo|
16312500|NCT00553982|Procedure|Patellar component|Resurfacing with onlay technique
16312501|NCT00553982|Procedure|No patellar component|Trimming of osteophytes when appropriate
16312502|NCT00553969|Drug|carvedilol phosphate|Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
16312503|NCT00553969|Drug|lisinopril|tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
16312504|NCT00553969|Drug|carvedilol phosphate and lisinopril|carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
16312505|NCT00553969|Drug|placebo and placebo|capsule once daily for 9 months; dosage unknown
16312506|NCT00553956|Behavioral|Narrative Exposure Therapy/Interpersonal Psychotherapy|The experimental group will receive 5 weekly individual sessions of NET in addition to 3 weekly individual sessions of IPT.
16312507|NCT00553943|Drug|Rituximab|375 mg/m2 D1
16312508|NCT00553943|Drug|Cytarabine|50 mg D3
16312509|NCT00553930|Drug|Pegylated interferon alfa-2a and Ribavirin|All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures.
16312510|NCT00553930|Drug|Pegylated interferon alfa 2a and Ribavirin|Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures.
16312511|NCT00553904|Dietary Supplement|Cranberry juice|480 ml of double strength cranberry juice daily for four weeks
16312512|NCT00553891|Drug|mometasone furoate nasal spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
16312513|NCT00553891|Drug|placebo nasal spray|One spray in each nostril once daily for 3 months.
16312514|NCT00553878|Drug|Dutasteride|dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
16312515|NCT00553865|Drug|OJP-2028|Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.
16312516|NCT00553852|Drug|Recombinant GH Saizen (Merck-Serono)|Treatment will start at the initial dose 0.15-0.30 mg/day; dose adjustment will be performed according to IGF-I levels. The duration of medical treatment is 6 months.
16312517|NCT00553839|Drug|ketamine hydrochloride|Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
16312518|NCT00553813|Drug|TPI 287|Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.
16312519|NCT00553800|Drug|bevacizumab|
16312521|NCT00553787|Drug|VI-0521|phentermine 15 mg and topiramate 92 mg, po once daily
16312522|NCT00553787|Drug|VI-0521|phentermine 7.5 mg and topiramate 46 mg, po once daily
16312523|NCT00553787|Drug|VI-0521|placebo
16312524|NCT00553774|Dietary Supplement|Cocoa Flavanols|Cocoa Flavanols (BD for 21 - 28 days)
16312525|NCT00553774|Other|Placebo|Placebo (BD 21 - 28 Days)
16312526|NCT00553761|Device|Pattern electroretinogram|Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.
16312527|NCT00553748|Drug|F-18 FLT|One - 10 mci dose of F-18 FLT is administered IV over about 5 seconds prior to PET imaging. Each imaging dose contains no more than 6.1 micrograms of FLT.
16312528|NCT00553735|Drug|Cyclosporine A 0.05%|Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
16312529|NCT00553735|Drug|Arificial Tear|Artificial Tear - three times a day for 18 months.
16312530|NCT00553722|Drug|Eplerenone|Administer Eplerenone, 25 mg,orally twice daily for 4 weeks.
16312531|NCT00553722|Drug|Placebo|Administer a placebo tablet orally twice daily for 4 weeks.
16312532|NCT00553709|Drug|Nicotine|Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
16312533|NCT00553696|Drug|Cisplatin|Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
16312534|NCT00553696|Drug|S-1|S-1 80 mg/m2 on days 1-21 of each 28 day cycle
16312535|NCT00553696|Drug|Sunitinib|Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
16312536|NCT00553683|Drug|cyclophosphamide|
16312537|NCT00553683|Drug|poly ICLC|
16312538|NCT00553683|Procedure|hepatic artery embolization|
16312539|NCT00553683|Radiation|3-dimensional conformal radiation therapy|
16312540|NCT00553657|Drug|DETROL LA (drug)|
16312541|NCT00553644|Drug|Bortezomib|Given IV
16312542|NCT00553644|Other|Laboratory Biomarker Analysis|Correlative studies
16312543|NCT00553644|Drug|Lenalidomide|Given PO
16312544|NCT00553631|Biological|velaglucerase alfa|IV infusion, 60 U/kg every other week for 9 months
16312545|NCT00553631|Biological|imiglucerase|IV infusion, 60 U/kg every other week for 9 months
16312547|NCT00553605|Drug|Ketoprofen 100mg|Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
16312548|NCT00553605|Drug|Parecoxib 40mg|Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
16312549|NCT00553592|Drug|Bicifadine|600mg/day
16312550|NCT00553592|Drug|Bicifadine|placebo tablet
16312551|NCT00553592|Drug|Bicifadine|1200 mg
16312552|NCT00553566|Procedure|medical chart review|
16312553|NCT00553566|Procedure|questionnaire administration|
16312554|NCT00553566|Procedure|study of socioeconomic and demographic variables|
16312555|NCT00553553|Drug|Morphine sulphate|Intravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery
16312556|NCT00553553|Drug|Morphine hydrochloride, remifentanil hydrochloride|"Pre-induction intrathecal morphine HCl (< 3 attempts), single shot via 25 G pencil point spinal needle at 10 micrograms/kilogram
~Intra-operative intravenous remifentanil HCl at titratable dose range 0.1-0.25 micrograms/kilogram/minute until start of wound closure"
16312557|NCT00553540|Device|Back supports|The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
16312558|NCT00553527|Procedure|Humeral Stem replacement surgery|Patient will receive humeral stem replacement.
16312559|NCT00553514|Drug|AS900672-Enriched 10 microgram (mcg)|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
16312560|NCT00553514|Drug|AS900672-Enriched 20 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
16312561|NCT00553514|Drug|AS900672-Enriched 30 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
16312562|NCT00553514|Drug|AS900672-Enriched 40 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
16312563|NCT00553514|Drug|Follitropin alfa 75 international unit (IU)|Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
16312564|NCT00553514|Drug|Recombinant human chorionic gonadotropin (r-hCG)|Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm).
16312565|NCT00553501|Biological|epratuzumab|Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
16312566|NCT00553501|Biological|rituximab|Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV
16312642|NCT00553124|Procedure|laboratory biomarker analysis|
16312567|NCT00553488|Drug|Regular insulin (Humulin)|Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
16312568|NCT00553488|Drug|Insulin lispro (Humalog)|Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
16312569|NCT00553475|Drug|placebo|Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
16312570|NCT00553475|Drug|pregabalin|Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
16312571|NCT00553475|Drug|pregabalin|Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
16312572|NCT00553462|Drug|carboplatin|
16312573|NCT00553462|Drug|erlotinib hydrochloride|
16312574|NCT00553462|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16312575|NCT00553462|Radiation|radiation therapy|
16312576|NCT00553449|Drug|rabeprazole|
16312577|NCT00553436|Device|Tissue Apposition System (TAS) Device|Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
16312578|NCT00553423|Drug|Lactulose|Lactulose 30 ml q6h for 48 hrs
16312579|NCT00553423|Drug|Placebo|Placebo 30 ml q6hrly for 48 hrs
16312580|NCT00553410|Drug|Letrozole|Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
16312581|NCT00553410|Drug|Letrozole|Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
16312582|NCT00553371|Other|biomarker analysis|
16312583|NCT00553371|Procedure|computed tomography|
16312584|NCT00553358|Drug|Lapatinib|Small molecule receptor tyrosine kinase inhibitor
16312585|NCT00553358|Biological|Trastuzumab|Therapeutic Monoclonal Antibody
16312586|NCT00553358|Drug|Paclitaxel|antimicrotubule agent
16312587|NCT00553345|Drug|selenium|
16312588|NCT00553345|Drug|vitamin E|
16312589|NCT00553345|Procedure|chemoprevention|
16312590|NCT00553332|Drug|selumetinib|Given orally
16312591|NCT00553332|Other|laboratory biomarker analysis|Correlative studies
16312592|NCT00553319|Drug|Placebo|Placebo group
16312593|NCT00553319|Drug|Adderall-XR|Adderall-XR 60mg/day
16312594|NCT00553319|Drug|Adderall-XR|Adderall-XR 80mg/day
16312595|NCT00553306|Biological|therapeutic autologous lymphocytes|Given IV
16312596|NCT00553306|Biological|aldesleukin|Given subcutaneously
16312597|NCT00553306|Drug|cyclophosphamide|Given IV
16312598|NCT00553306|Procedure|biopsy|Optional correlative studies
16312599|NCT00553306|Other|immunohistochemistry staining method|Optional correlative studies
16312600|NCT00553306|Other|flow cytometry|Correlative studies
16312601|NCT00553306|Genetic|polymerase chain reaction|Correlative studies
16312602|NCT00553293|Drug|recombinant luteinizing hormone (Luveris)|75 iu/day form cycle day 6
16312603|NCT00553293|Drug|recombinant follicle stimulating hormone (Gonal-f)|rFSH 150 iu/day
16312604|NCT00553280|Drug|pregabalin|Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
16312605|NCT00553267|Drug|fixed dose combination of telmisartan+amlodipine|
16312606|NCT00553267|Drug|amlodipine|
16312607|NCT00553254|Drug|PF-00299804|Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent
16312608|NCT00553228|Biological|Tdap|0.5 mL IM once at visit #2
16312609|NCT00553228|Biological|Td|0.5 mL IM once at visit #2
16312610|NCT00553215|Procedure|quality-of-life assessment|
16312611|NCT00553215|Procedure|questionnaire administration|
16312612|NCT00553202|Biological|anti-thymocyte globulin|Given IV
16312613|NCT00553202|Drug|busulfan|Given IV
16312614|NCT00553202|Drug|cyclophosphamide|Given IV
16312615|NCT00553202|Drug|cyclosporine|Given IV or orally
16312616|NCT00553202|Drug|methotrexate|Given IV
16312617|NCT00553202|Drug|methylprednisolone|Given IV
16312618|NCT00553202|Drug|tacrolimus|Given IV
16312619|NCT00553202|Other|laboratory biomarker analysis|Correlative studies
16312620|NCT00553202|Other|pharmacological study|Correlative studies
16312621|NCT00553202|Procedure|allogeneic bone marrow transplantation|allogeneic bone marrow transplantation
16312622|NCT00553202|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic hematopoietic SCT
16312623|NCT00553189|Drug|ABT-888|
16312624|NCT00553189|Drug|Topotecan|
16312625|NCT00553176|Other|No intervention|At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations
16312626|NCT00553163|Behavioral|Gut focussed hypnotherapy|Gut focussed hypnotherapy
16312627|NCT00553163|Behavioral|Control educational sessions|Control educational sessions
16312628|NCT00553150|Drug|everolimus|
16312629|NCT00553150|Drug|temozolomide|
16312630|NCT00553150|Radiation|radiation|
16312631|NCT00553137|Drug|fluconazole|750 mg (5 tablets of 150 mg tablets)taken once
16312632|NCT00553137|Drug|fluconazole|150 mg fluconazole tablets once daily for 14 days
16312633|NCT00553124|Drug|selenium|
16312634|NCT00553124|Drug|vitamin E|
16312635|NCT00553124|Procedure|biopsy|
16312636|NCT00553124|Procedure|chemoprevention|
16312637|NCT00553124|Procedure|cryopreservation|
16312638|NCT00553124|Procedure|cytology specimen collection procedure|
16312639|NCT00553124|Procedure|diagnostic procedure|
16312640|NCT00553124|Procedure|gene expression analysis|
16312644|NCT00553124|Procedure|mutation analysis|
16312645|NCT00553124|Procedure|polymerase chain reaction|
16312646|NCT00553124|Procedure|quality-of-life assessment|
16312647|NCT00553124|Procedure|questionnaire administration|
16312648|NCT00553124|Procedure|study of socioeconomic and demographic variables|
16312649|NCT00553111|Other|educational video|educational video
16312650|NCT00553098|Biological|Alemtuzumab|Given IV
16312651|NCT00553098|Procedure|Allogeneic Bone Marrow Transplantation|Undergo HCT
16312652|NCT00553098|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
16312653|NCT00553098|Drug|Cyclosporine|Given PO or IV
16312654|NCT00553098|Drug|Fludarabine Phosphate|Given IV
16312655|NCT00553098|Other|Laboratory Biomarker Analysis|Correlative study
16312656|NCT00553098|Drug|Mycophenolate Mofetil|Given PO or IV
16312657|NCT00553098|Radiation|Total-Body Irradiation|Undergo low dose TBI
16312658|NCT00553072|Drug|Magnesium sulphate|250 mg/kg/dose in 1 ml normal saline
16312659|NCT00553072|Drug|Normal saline|1 ml/kg/dose
16312660|NCT00553059|Drug|dexamethasone|10 mg IV 30 minutes prior to administration of chemotherapy
16312661|NCT00553059|Drug|dronabinol|5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy
16312662|NCT00553059|Drug|palonosetron hydrochloride|0.25 mg IV 30 minutes prior to administration of chemotherapy
16312663|NCT00553059|Other|placebo|1 tablet by mouth three times a day beginning 30 minutes before chemotherapy
16312664|NCT00553046|Other|survey administration|application of a family survey on last 3 months of life for their relatives under HMV
16312665|NCT00553033|Procedure|Laparoscopic liver surgery|Ultrasonic dissector, harmonic scalpel
16312666|NCT00553020|Drug|Insulin glargine|"Lantus (commercial formulation, Reference):
~10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)
~NPH-insulin (Protaphan) (Test):
~10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)"
16312667|NCT00553007|Procedure|Periodontal therapy|Normal periodontal therapy is performed.
16312668|NCT00552994|Device|Cypher Select plus|Drug eluting stent
16312669|NCT00552994|Device|Xience V stent|Drug eluting stent
16312670|NCT00552981|Procedure|inhalation of warm air in a Finnish sauna|three times on three following days, each 2-3 minutes
16312671|NCT00552981|Procedure|inhalation of ambient air in a Finnish sauna|three times on three following days, each 2-3 minutes
16312672|NCT00552942|Procedure|laparoscopic gastric bypass plus omentectomy|
16312673|NCT00552929|Drug|Sugammadex|"After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered."
16312674|NCT00552916|Device|Compex Motion Stimulator|'True' Functional Electrical Stimulation Assisted Walking
16312675|NCT00552916|Device|Compex Motion Stimulator|'False' FES
16312676|NCT00552903|Behavioral|Health coaching|Personal health coach providing advice and counselling by telephone, weekly contacts
16312677|NCT00552890|Other|modified Atkins diet|subjects assigned to follow modified Atkins diet for 1 year
16312678|NCT00552890|Other|ADA recommended diet|subjects assigned to follow ADA recommended diet for period of 1 year
16312679|NCT00552877|Device|Percutaneous coronary intervention (Xience V stent)|Cypher Select plus coronary stent Xience V coronary stent
16312680|NCT00552864|Drug|Ropivacaine|0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.
16312681|NCT00552864|Drug|Levobupivacaine|0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.
16312682|NCT00552851|Drug|pegvisomant|booster dosage 80 mg once sc., than 10 mg once per day, uptitration in steps of 5 mg up to an IGF-1 level in the normal range (every 4 weeks), max. 30 mg once per day. Duration of treatment: one year
16312683|NCT00552838|Behavioral|Academic Detailing by the Antimicrobial Utilization Team (AUT)|Physicians caring for patients who were prescribed one of three antimicrobials were randomly assigned to academic detailing by the AUT. The AUT would review the antimicrobial prescription and provide consultation to the ordering physician if the prescription is appropriate and provide feedback on a better alternative if inappropriate.
16312684|NCT00552812|Device|Stent therapy of aortic coarctation|Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
16312685|NCT00552799|Drug|Penicillin VK|Biconcave tablet 250mg oral, b.d.
16312686|NCT00552799|Other|placebo|biconcave tablet matching active comparator as much as possible in size and shape
16312687|NCT00552786|Drug|N-acetylcysteine (NAC)|600mg twice daily for 2 weeks
16312688|NCT00552786|Drug|glucose|1 gm glucose capsule
16312689|NCT00552773|Drug|Cyclamen Europaeum|Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
16312690|NCT00552760|Drug|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
16312691|NCT00552760|Drug|Placebo|one tablet at bedtime for up to 6 months
16312692|NCT00552747|Drug|fenofibrate|fenofibrate 160 mg capsules qd
16312693|NCT00552747|Drug|placebo|capsules placebo
16312884|NCT00551421|Other|gene expression analysis|Correlative study
16312694|NCT00552734|Device|Insulin Guidance Software|At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.
16312695|NCT00552721|Other|Physical therapy with strength training|12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.
16312696|NCT00552721|Other|Physical therapy without strength training|12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.
16312697|NCT00552708|Drug|COREG CR|
16312698|NCT00552708|Drug|Lisinopril|
16312699|NCT00552695|Device|Lidocaine tetracaine|Lidocaine 70 mg/tetracaine 70 mg
16312700|NCT00552695|Device|Placebo|Placebo patch identical in appearance to Synera
16312701|NCT00552682|Drug|Duloxetine 60 mg, QD|Duloxetine 60 mg, 1 table/day, 1 year
16312702|NCT00552669|Drug|Oral sirolimus|Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
16312703|NCT00552669|Device|Drug Eluting stent|Any Drug eluting stent
16312704|NCT00552656|Device|Firebird(TM) Sirolimus-Eluting Stent|balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm
16312705|NCT00552643|Device|Suspension of polystyrene beads (POLYHEAL 1)|Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle
16312706|NCT00552643|Device|Saline (0.9% NaCl)|Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle
16312707|NCT00552630|Device|d-penicillamine|d-penicillamine twice daily, 15 mg/kg/day, for 6 weeks
16312708|NCT00552630|Drug|placebo|placebo with same characteristics as drug
16312709|NCT00552617|Drug|Sugammadex|"After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered"
16312710|NCT00552617|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
~At reappearance of T2 the randomized single dose of Placebo IV was administered"
16312711|NCT00552617|Drug|Rocuronium|"After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary."
16312712|NCT00552617|Drug|Vecuronium|After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
16312713|NCT00552604|Drug|standardized cannabis extract|Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily
16312714|NCT00552604|Drug|Placebo|Matching placebo capsules, twice daily
16312715|NCT00552591|Behavioral|12-week risk reduction program, managed by a Heart Health Educator|The educator and participant will negotiate a personal plan for achieving the goals through lifestyle change (i.e. smoking cessation, increased exercise, improved nutrition) and, if necessary, pharmacotherapy coordinated by the participant's personal physician. Educational modules have been developed to address specific lifestyle issues including smoking cessation, healthy eating, exercise, and weight management, and will be provided to participants as required. A summary of the risk factor profile and personal plan will be incorporated into a report for the participant's personal physician as well. Participants will also receive telephone-based motivational counseling sessions for 12 weeks to address specific lifestyle issues.
16312716|NCT00552578|Drug|buprenorphine/naloxone|sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response)
16312717|NCT00552578|Drug|buprenorphine/naloxone|sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response
16312718|NCT00552565|Drug|Rezular 15mg|Oral Tablets
16312719|NCT00552565|Drug|Placebo|placebo
16312720|NCT00552565|Drug|Rezular|Rezular 37.5mg 3xday up to 12 weeks
16312721|NCT00552565|Drug|Rezular|Rezular 75mg 3xday up to 12 weeks
16312722|NCT00552552|Behavioral|Fatigue Patient Education Program (FIBS)|6 weekly sessions, 90 min each
16312723|NCT00552552|Behavioral|Fatigue Patient Education Program (FIBS)|Participation in the program after the second follow-up
16312724|NCT00552539|Other|'educational video'|'educational video'
16312725|NCT00552526|Dietary Supplement|Ketogenic diet|Ketogenic diet is a very strict high fat diet
16312726|NCT00552526|Drug|Antiepileptic drug (AED)|An AED,not used by the patient before, which we consider to be the most appropriate will be given orally or by gastrostomy. Serum concentration, the body weight, side effects and effects on the epilepsy will be considered when deciding the dose of the AED. Traditions for amount of medicine/kg body weight or optimal serum concentration at our center will be followed. This tradition will be the same as in other major European epilepsy centers but might propose lower, but not higher amounts than recommended by the drug company. Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate, zonisamide, vigabatrin, tiagabil, lamotrigine, pregabalin, rufinamide, clobazam, clonazepam, tiagabine, gabapentin, phenytoin, phenobarbital, ethosuximide, acetazolamide, nitrazepam and other new antiepileptic drugs that might be released during the study period.
16312727|NCT00552513|Procedure|Early Coronary Intervention|Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (and within 24 hours of randomisation).
16312728|NCT00552513|Procedure|Delayed Coronary Intervention|Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
16312729|NCT00552500|Drug|Depakote (valproate)|500 mg -2000 mg QD based on individual tolerance and VPA levels
16312730|NCT00552487|Drug|synacthen|1 µg synacthen in the vein
16312731|NCT00552474|Device|Libra Deep Brain Stimulation System|Active DBS Therapy
16312732|NCT00552474|Device|Libra Deep Brain Stimulation System|Implanted system but no stimulation
16312733|NCT00552461|Drug|rituximab|IV, 1000 mg, two weeks, 2 times
16312734|NCT00552448|Device|High Frequency Chest Compression VEST|every 6 hours for 20 minutes
16312735|NCT00552435|Device|Laser photocoagulation|Laser therapy is applied using a slit lamp and specific laser contact lens.
16312736|NCT00552422|Drug|domperidone|10mg orally four times per day
16312737|NCT00552409|Dietary Supplement|Cholecalciferol|2000 IU by mouth daily for one year
16312738|NCT00552409|Dietary Supplement|Placebo|One softgel daily for one year
16312739|NCT00552396|Drug|Anti-KIR (1-7F9)|human monoclonal antibody
16312740|NCT00552383|Procedure|NIDCAP based developmental care|"Infants in the intervention arm will receive care in the NICU by nursing staff who have received basic education in NIDCAP - based developmental care. They will also have NIDCAP behavioural observations performed by NIDCAP - Certified staff [this includes 3 of the investigators], at intervals during their stay at the study site NICU. These behavioural observations form the basis for behaviourally guided baby -friendly care, so that the timing and pace of caregiving is synchronised to the infant's readiness. Parents are actively encouraged to become the infant's primary caregiver in the NICU."
16312741|NCT00552370|Drug|Lantus®|
16312742|NCT00552344|Biological|Cimzia|"Active substance: Certolizumab Pegol
~Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe
~Concentration: 200 mg/ml
~Route of Administration: Subcutaneous use"
16312743|NCT00552331|Device|Plates to treat fractures of the distal femur|use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures
16312744|NCT00552331|Device|LISS|treatment of distal femur fractures with less invasive stabilization systems
16312745|NCT00552305|Drug|lacosamide|50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
16312746|NCT00552279|Biological|Cervarix TM|Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
16312747|NCT00552279|Biological|Cervarix TM|Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
16312748|NCT00552266|Drug|Methylphenidate|tablets 10-60 mg/day administered once or twice daily 6 weeks
16312749|NCT00552253|Drug|Levothyroxin treatment|Levothyroxin 100 micogram will be administered once daily 1 hour before meal of just after meal for 3 months, and the dose will be titrate to keep serum TSH level between 0.1~0.3 mU/L. It will be discontinued for 3 months. Then
16312750|NCT00552240|Drug|tenofovir DF 300 mg QD|300 mg QD
16312751|NCT00552240|Drug|tenofovir DF 300 mg QD|300 mg QD
16312752|NCT00552240|Drug|emtricitabine 200 mg QD|200 mg QD
16312753|NCT00552240|Drug|emtricitabine 200 mg QD|200 mg QD
16312754|NCT00552240|Drug|Nevirapine 200 mg BID|200 mg BID
16312755|NCT00552240|Drug|Atazanavir 300 mg|300 mg QD
16312756|NCT00552240|Drug|Ritonavir 100 mg|100 mg QD
16312757|NCT00552227|Drug|ruboxistaurin|oral 32 mg daily
16312758|NCT00552227|Other|placebo|placebo
16312759|NCT00552214|Device|Blood test|Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
16312760|NCT00552201|Drug|Tacrolimus|Administration Twice a day after adjustment to blood level
16312761|NCT00552188|Drug|VIA-2291|100 mg, oral dosing, 1 time daily for 24 weeks
16312762|NCT00552188|Drug|Placebo|oral dosing, 1 time daily for 24 weeks
16312763|NCT00552175|Drug|Duloxetine hydrochloride - 40 mg|duloxetine 40 mg taken orally every day
16312764|NCT00552175|Drug|placebo|placebo taken orally every day
16312765|NCT00552175|Drug|Duloxetine hydrochloride - 60 mg|duloxetine 60 mg taken orally every day
16312766|NCT00552162|Procedure|NOTES Transvaginal Cholecystectomy|The gallbladder will be dissected free and will be removed through an incision in the vagina.
16312767|NCT00552162|Procedure|NOTES Transvaginal Appendectomy|The appendix will be dissected free and will be removed through an incision in the vagina.
16312768|NCT00552149|Drug|Gemox, Cetuximab|"GEMOX (Arms 1 and 2), every two weeks:
~Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h
~Cetuximab (ErbituxÒ) (Arm B only) every two weeks:
~(chemotherapy will be started one hour after the end of the cetuximab infusion).
~Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes"
16312769|NCT00552136|Procedure|Ankle Arthroplasty|
16312770|NCT00552136|Procedure|Ankle Arthrodesis|
16312771|NCT00552110|Drug|OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)|MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).
16312772|NCT00552110|Drug|OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)|MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.
16312773|NCT00552110|Drug|mometasone furoate nasal spray (MFNS) once daily|MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.
16312774|NCT00552110|Drug|oxymetazoline nasal spray (OXY) twice daily|OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.
16312775|NCT00552110|Drug|Placebo|Matching placebo to MFNS given every morning and every evening x 2 weeks.
16312776|NCT00552097|Drug|ezetimibe (plus simvastatin)|oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
16312777|NCT00552097|Drug|placebo (plus simvastatin)|tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
16312778|NCT00552084|Drug|Fish oil|Fish oil supplements 4 gms will be taken daily for 24 weeks.
16312779|NCT00552084|Drug|Placebo|Placebo supplements will be taken daily for 24 weeks.
16312780|NCT00552071|Drug|Octreotide LAR 30 MG Injection|Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.
16312781|NCT00552058|Biological|certolizumab pegol (CDP870, CZP)|Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
16312782|NCT00552058|Other|Placebo|Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
16312783|NCT00552032|Drug|Mometasone Furoate nasal spray|Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
16312784|NCT00552032|Drug|Placebo|Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
16312785|NCT00552006|Behavioral|Narrative Exposure Therapy|"Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.
~NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner."
16312786|NCT00552006|Behavioral|Academic Counseling|"Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.
~AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner."
16312787|NCT00551993|Procedure|robotic laparoscopic sacrocolpopexy|Da Vinci Robot
16312788|NCT00551993|Procedure|Laparoscopic Sacral Colpopexy|Standard laparoscopy
16312789|NCT00551980|Behavioral|Cognitive, Relaxation, Exercise Therapy|The intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce hyperfunction of the craniofacial and cervical muscles during the day
16312790|NCT00551967|Procedure|Hip replacement|Surgical implantation of hip replacement components for the treatment of osteoarthritis
16312791|NCT00551954|Drug|acarbose|100 mg (tablets) t.i.d.
16312792|NCT00551954|Drug|placebo|one tablet t.i.d.
16312793|NCT00551941|Procedure|BMP-7 in adjunct to fresh frozen allograft|non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
16312794|NCT00551941|Procedure|allograft together with DBM|non-union of diaphysary tibial fractures treated with allograft together with DBM
16312795|NCT00551928|Drug|Melphalan|High dose Melphalan 200mg/sm with autologous stem cell support
16312796|NCT00551928|Drug|Lenalidomide|Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids (day 22 to 28), for 6 cycles every 28 days.
16312797|NCT00551928|Drug|Prednisone|Given orally at the dose of 2 mg/Kg for 4 days followed by a 24 day rest period (days 5 to 28), for 6 cycles every 28 days
16312798|NCT00551928|Drug|Melphalan|Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days, followed by a 24 days rest period (day 5 to 28)for 6 cycles every 28 days
16312799|NCT00551915|Biological|AR51 (12, 10)|vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
16312800|NCT00551915|Biological|PR51 (3, 10)|vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
16312801|NCT00551915|Biological|PR51 (6, 10)|vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
16312802|NCT00551915|Biological|PENTACEL™|licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label
16312803|NCT00551915|Biological|RECOMBIVAX HB™|licensed vaccine for hepatitis, administered open-label
16312804|NCT00551902|Procedure|Trabeculectomy with anterior chamber infusion system|Trabeculectomy with anterior chamber infusion system
16312805|NCT00551902|Procedure|Trabeculectomy without anterior chamber infusion system|Standard trabeculectomy surgery
16312806|NCT00551889|Drug|celecoxib|
16312807|NCT00551889|Drug|cyclophosphamide|
16312808|NCT00551889|Other|laboratory biomarker analysis|
16312809|NCT00551876|Drug|MK0653, ezetimibe / Duration of Treatment: 30 Weeks|
16312810|NCT00551876|Drug|Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks|
16312811|NCT00551863|Behavioral|IVPT|Violence prevention intervention based on Motivational Interviewing and CBT
16312812|NCT00551850|Drug|AV-412|oral solid dosage form administered three times weekly for 4 weeks (1 cycle)
16312813|NCT00551824|Drug|Mitomycin C|Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.
16312814|NCT00551811|Drug|SB-656933-AAA|SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
16312815|NCT00551811|Drug|Placebo|Placebo tablets will be intended to be administered orally.
16312816|NCT00551798|Procedure|TEP au MIBI|Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.
16312817|NCT00551772|Drug|SB-742457|
16312818|NCT00551759|Drug|5-Fluorouracil|given IV
16312819|NCT00551759|Drug|Oxaliplatin|given IV
16312820|NCT00551759|Drug|Cetuximab|given IV
16312821|NCT00551759|Drug|Docetaxel|given IV
16312822|NCT00551759|Procedure|Surgery|Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.
16312823|NCT00551759|Radiation|Radiotherapy|Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.
16312824|NCT00551746|Dietary Supplement|Purple Grape Juice|Grape Juice
16312825|NCT00551733|Drug|carboplatin|Given IV
16312826|NCT00551733|Drug|paclitaxel|Given IV
16312827|NCT00551733|Drug|paclitaxel poliglumex|Given IV
16312885|NCT00551421|Other|mutation analysis|Correlative study
16312828|NCT00551720|Behavioral|Standard Care|Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
16312829|NCT00551720|Behavioral|Motivational Enhancement|Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
16312830|NCT00551707|Drug|CRx-102 (2.7/180)|prednisolone 2.7 mg plus dipyridamole 180 mg
16312831|NCT00551707|Drug|prednisolone|prednisolone (2.7 mg)
16312832|NCT00551707|Drug|dipyridamole|dipyridamole 360 mg
16312833|NCT00551707|Drug|placebo|placebo
16312834|NCT00551707|Drug|CRx-102 (2.7/360)|Prednisolone 2.7 mg plus Dipyridamole 360 mg
16312835|NCT00551694|Drug|GSK256073A tablets|
16312836|NCT00551681|Device|biventricular pacemaker with epicardial left ventricular lead|epicardial left ventricular lead placement
16312837|NCT00551681|Device|transvenous left ventricular lead placement|implantation of biventricular pacemaker with transvenous left ventricular lead placement
16312838|NCT00551668|Procedure|proximal patellar surgery|Initial proximal patellar surgery
16312839|NCT00551668|Procedure|Nonoperative|Nonoperative without surgery
16312840|NCT00551642|Drug|Nitric oxide|Nitric Oxide vapour (gas) for inhalation (400 ppm)
16312841|NCT00551642|Drug|Placebo|Placebo gas for inhalation
16312842|NCT00551629|Biological|AR51 (12, 10)|vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
16312843|NCT00551629|Biological|PR51 (3, 10)|vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
16312844|NCT00551629|Biological|PR51 (6, 10)|vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
16312845|NCT00551629|Biological|PR51 (6, 15)|vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
16312846|NCT00551616|Drug|CDB-2914|Single dose
16312847|NCT00551616|Drug|Levonorgestrel|Single dose
16312848|NCT00551603|Drug|switch (epoetinum beta, darbepoetinum)|switching from epoetinum beta once weekly to once-fortnightly darbepoetinum
16312849|NCT00551603|Drug|continuation (darbepoetinum)|continuation of the previous darbepoetinum administration schedule
16312850|NCT00551590|Drug|Placebo tablet|placebo PO (placebo control for sitagliptin) for three days
16312851|NCT00551590|Drug|Sitagliptin tablet|Sitagliptin 100 mg PO for three days.
16312852|NCT00551590|Drug|Saline infusion|Saline IV (placebo control for exendin(9-39)) on two consecutive study days
16312853|NCT00551590|Drug|Exendin(9-39) infusion|Exendin(9-39) IV on two consecutive study days.
16312854|NCT00551577|Procedure|neoadjuvant chemotherapy (Carboplatin/Docetaxel)|3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
16312855|NCT00551577|Procedure|neoadjuvant chemotherapy (Carboplatin/Docetaxel)|2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative
16312856|NCT00551564|Drug|rosiglitazone maleate|Rosiglitazone tablets 4 mg dose will be administered orally by subjects
16312857|NCT00551551|Other|Pelvic floor muscle training with physiotherapist|8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
16312858|NCT00551551|Other|Written information about kegel exercises|Information about pelvic floor disorders prevention with personal pelvic floor exercises
16312859|NCT00551538|Drug|Lispro mix 75/25|Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
16312860|NCT00551538|Drug|Glargine|SC injection, once-daily, given in conjunction with oral antidiabetic medications.
16312861|NCT00551525|Radiation|Radiotherapy|3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.
16312862|NCT00551525|Drug|Samarium 153|Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
16312863|NCT00551512|Drug|CBP501 and Cisplatin|CBP501 is given IV on Day 1 of each cycle (every 21 days). Dose escalation of CBP501 and cisplatin will be starting doses of 3.6 mg/m² CBP501 and 50 mg/m² cisplatin (Dose Level 1). Step 1, if during the first 2 cycles, at least 2 out of 3 to 6 patients experience Dose Limiting Toxicity (DLT) at 50 mg/m² cisplatin, then the cisplatin dose will be de-escalated to 30 mg/m². If no more than 1 out of 6 patients experiences DLT, cisplatin dose will be escalated to 75 mg/m². Step 2, dose escalation will be performed using the cisplatin MTD, with escalating CBP501 doses. CBP501 dose escalation will take place until the MTD has been defined or 74 mg/m² is reached.
16312864|NCT00551499|Device|CRT + AOP|The CSA group will undergo 2 sleep evaluation on two consecutive nights, during which the device will be programmed according to the randomization scheme (one night CRT, DDD/45 and the other CRT, DDD/15 bpm over mean nocturnal heart rate). The mean nocturnal heart rate over the last week is derived from the device memory.
16312865|NCT00551486|Procedure|ultrasound-guided fine needle aspiration biopsy|Fine needle aspiration (FNA)with cytologic analysis has become a mainstay of thyroid nodule evaluation was used. Nonpalpable nodules were aspirated under ultrasound guidance to facilitate precise targeting of the nodule and to sample the part most likely to improve diagnostic yield.
16312866|NCT00551473|Drug|Lavoltidine|
16312867|NCT00551460|Drug|arsenic trioxide|
16312868|NCT00551460|Drug|gemtuzumab ozogamicin|
16312869|NCT00551460|Drug|mercaptopurine|
16312870|NCT00551460|Drug|methotrexate|
16312871|NCT00551460|Drug|tretinoin|
16312872|NCT00551447|Drug|MK0653, ezetimibe / Duration of Treatment: 27 Weeks|
16312873|NCT00551447|Drug|MK0733, simvastatin / Duration of Treatment: 27 Weeks|
16312874|NCT00551447|Drug|Comparator: simvastatin / Duration of Treatment: 27 Weeks|
16312875|NCT00551434|Dietary Supplement|Creatine|Creatine 21 g daily
16312876|NCT00551434|Dietary Supplement|L-arginine and creatine|L-arginine
16312877|NCT00551434|Dietary Supplement|l-arginine|l-arginine 9 g daily
16312878|NCT00551434|Dietary Supplement|placebo, double|placebo
16312879|NCT00551421|Biological|pertuzumab|Given IV
16312880|NCT00551421|Biological|cetuximab|Given IV
16312881|NCT00551421|Drug|irinotecan hydrochloride|Given IV
16312882|NCT00551421|Other|immunohistochemistry staining method|Correlative study
16312883|NCT00551421|Other|fluorescence in situ hybridization|Correlative study
16312886|NCT00551421|Other|polymerase chain reaction|Correlative study
16312887|NCT00551421|Other|laboratory biomarker analysis|Correlative study
16312888|NCT00551395|Procedure|selective laser trabeculoplasty - early completion|180 degrees of laser on day 1 and other 180 degrees on day 2.
16312889|NCT00551395|Procedure|Selective laser trabeculoplasty - late completion|180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.
16312890|NCT00551382|Drug|Muntelukast|Tablets or granules; 4 mg once a day for 12 weeks
16312891|NCT00551382|Drug|Placebo|Look alike tablets or granules 1 per day for 12 weeks
16312892|NCT00551369|Radiation|SBRT|SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
16312893|NCT00551356|Drug|Insulin lispro mix 25|Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
16312894|NCT00551356|Drug|Glargine|Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
16312895|NCT00551343|Drug|Exenatide|10ug Exenatide single s.c. injection
16312896|NCT00551330|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily
16312897|NCT00551330|Drug|Placebo|One tablet of placebo once daily
16312898|NCT00551317|Drug|Darapladib (SB480848)|
16312899|NCT00551304|Device|Ardian Catheter|
16312900|NCT00551291|Drug|Mycophenolate mofetil|1 gm twice daily orally until end of study.
16312901|NCT00551291|Drug|Prednisone|10 mg/day orally until end of study.
16312902|NCT00551291|Drug|Erythropoietin Beta|Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
16312903|NCT00551278|Device|GeneSearch™ Breast Lymph Node (BLN) Assay|"For in vitro diagnostic use only.
~The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.
~Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required."
16312904|NCT00551265|Drug|Cyclophosphamide|Given IV
16312905|NCT00551265|Procedure|Laboratory Biomarker Analysis|Correlative studies
16312906|NCT00551265|Biological|Oregovomab|Given IV
16312907|NCT00551252|Drug|Imatinib mesylate plus Gemcitabine|Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles
16312908|NCT00551239|Biological|rituximab|Given IV
16312909|NCT00551239|Drug|fludarabine phosphate|Given IV
16312910|NCT00551239|Drug|pixantrone dimaleate|Given IV
16312911|NCT00551213|Biological|Robatumumab|
16312912|NCT00551213|Drug|Irinotecan|
16312913|NCT00551213|Biological|Cetuximab|
16312914|NCT00551213|Drug|Capecitabine|
16312915|NCT00551213|Drug|FOLFOX|Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX)
16312916|NCT00551213|Drug|CAPEOX/XELOX|Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX)
16312917|NCT00551213|Drug|FOLFIRI|Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI)
16312918|NCT00551200|Drug|HPN-100|Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
16312919|NCT00551200|Drug|BUPHENYL®|BUPHENYL® (sodium phenylbutyrate) tablets and powder have been approved for marketing in the United States since 1996 as an adjunctive therapy in the long-term management of patients with UCDs involving deficiencies of CPS, OTC, or ASS.
16312920|NCT00551187|Biological|V504|V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
16312921|NCT00551187|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
16312922|NCT00551187|Biological|Comparator: Placebo (unspecified)|V504 Placebo in 3 dose regimen for 6 month treatment period.
16312923|NCT00551174|Drug|ibandronate [Bonviva/Boniva]|3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
16312924|NCT00551174|Drug|ibandronate [Bonviva/Boniva]|2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
16312925|NCT00551161|Drug|memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 10 mg orally b.i.d., in addition to their ongoing stable cholinesterase inhibitor treatment
16312926|NCT00551148|Drug|PD 0200390|oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
16312927|NCT00551148|Drug|PD 0200390|oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
16312928|NCT00551148|Drug|PD 0200390|oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
16312929|NCT00551148|Drug|PD 0200390|oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
16312930|NCT00551148|Other|Placebo|oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
16312931|NCT00551135|Drug|Pregabalin|150 mg BID
16312932|NCT00551135|Drug|placebo|Placebo
16312933|NCT00551135|Drug|Pregabalin|75 mg BID
16312934|NCT00551135|Drug|Pregabalin|25 mg BID
16312935|NCT00551122|Biological|filgrastim|
16312936|NCT00551122|Biological|lenograstim|
16312937|NCT00551122|Biological|pegfilgrastim|
16312938|NCT00551122|Drug|cisplatin|
16312939|NCT00551122|Drug|gemcitabine hydrochloride|
16312940|NCT00551122|Drug|ifosfamide|
16312941|NCT00551122|Drug|paclitaxel|
16312942|NCT00551109|Drug|placebo|placebo, oral administration, once daily for 8 weeks
16312943|NCT00551109|Drug|SA4503 Low|Low dose, oral administration, once daily for 8 weeks
16312944|NCT00551109|Drug|SA4503 High|High dose, oral administration, once daily for 8 weeks
16312945|NCT00551096|Drug|Gemcitabine|Gemcitabine administered intravenously over 30 minutes on days 1, 8 and 15 of each cycle at a fixed dose of 1000mg/m2.
16312946|NCT00551096|Drug|Capecitabine|Capecitabine administered orally at 1660 mg/m2/day divided into two doses for 21 days followed by a week-off.
16312947|NCT00551096|Drug|ZD6474|Administered orally at 300 mg/day once daily. One cycle will consist of 28 days
16312948|NCT00551083|Other|Computerized Decision Support System for Depression (CDSS-D)|The CDSS for depression was based on an up-to-date model of the Texas Medication Algorithm Project that employs the principles of Measurement Based Care (MBC), while at the same time having a user interface for providers that is easy-to-use. MBC is the systematic use of measuring clinical outcomes at routine visits to guide treatment management. These outcomes may include symptoms, side effects, and medication adherence. Recent efforts from the large, multi-site effectiveness study, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), show that a treatment plan guided by MBC is integral in implementing algorithm based care.
16312949|NCT00551083|Other|Usual Care (UC)|"Usual Care was up to the discretion of the study physician and the patient treated. These physicians were provided with up-to-date treatment protocols for depression, but were not instructed to strictly adhere to a treatment algorithm. Therefore, they treated depressed patients as they usually would."
16312950|NCT00551070|Other|Laboratory Biomarker Analysis|Correlative studies
16312951|NCT00551070|Other|Pharmacological Study|Correlative studies
16312952|NCT00551070|Drug|Selumetinib|Given PO
16312953|NCT00551070|Drug|Selumetinib Sulfate|Given PO
16312954|NCT00551057|Behavioral|Expression type|to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue
16312955|NCT00551044|Drug|Bicalutamide|Bicalutamide 150mg once daily, oral administration, for 12 months
16312956|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)|0.1 mL, Intradermal (ID)
16312957|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)|0.1 mL, Intradermal (ID)
16312958|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)|0.5 mL, Intramuscular (IM)
16312959|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (High-dose)|0.5 mL, Intramuscular (IM)
16312960|NCT00551031|Biological|Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)|0.5 mL, Intramuscular (IM)
16312961|NCT00551018|Drug|Vicriviroc|one 30 mg tablet QD
16312962|NCT00551018|Drug|emtricitabine and tenofovir disoproxil fumarate|one 200/300 combination tablet QD
16312963|NCT00551005|Drug|celecoxib|
16312964|NCT00551005|Drug|etoposide|
16312965|NCT00551005|Other|immunoenzyme technique|
16312966|NCT00551005|Other|laboratory biomarker analysis|
16312967|NCT00550992|Biological|anti-thymocyte globulin|
16312968|NCT00550992|Drug|asparaginase|
16312969|NCT00550992|Drug|busulfan|
16312970|NCT00550992|Drug|cyclophosphamide|
16312971|NCT00550992|Drug|cyclosporine|
16312972|NCT00550992|Drug|cytarabine|
16312973|NCT00550992|Drug|daunorubicin hydrochloride|
16312974|NCT00550992|Drug|etoposide|
16312975|NCT00550992|Drug|leucovorin calcium|
16312976|NCT00550992|Drug|melphalan|
16312977|NCT00550992|Drug|mercaptopurine|
16312978|NCT00550992|Drug|methotrexate|
16312979|NCT00550992|Drug|mitoxantrone hydrochloride|
16312980|NCT00550992|Drug|pegaspargase|
16312981|NCT00550992|Drug|prednisolone|
16312982|NCT00550992|Drug|prednisone|
16312983|NCT00550992|Drug|therapeutic hydrocortisone|
16312984|NCT00550992|Drug|thioguanine|
16312985|NCT00550992|Drug|vincristine sulfate|
16312986|NCT00550992|Procedure|allogeneic bone marrow transplantation|
16312987|NCT00550992|Procedure|allogeneic hematopoietic stem cell transplantation|
16312988|NCT00550992|Procedure|umbilical cord blood transplantation|
16312989|NCT00550966|Behavioral|Psychoeducative program in fibromyalgic patients|Multi-component program including information about the illness, counselling about physical exercise and training in autogenic relaxation. The intervention consists on nine 2 hour sessions delivered during a two month period. The pharmacological treatment prescribed by the physician is maintained in both groups.
16312990|NCT00550953|Drug|telmisartan+amlodipine|
16312991|NCT00550953|Drug|telmisartan|
16312992|NCT00550927|Biological|bevacizumab|
16312993|NCT00550927|Drug|enzastaurin hydrochloride|
16312994|NCT00550927|Other|diagnostic laboratory biomarker analysis|
16312995|NCT00550927|Other|pharmacological study|
16312996|NCT00550901|Drug|cisplatin|
16312997|NCT00550901|Drug|dexrazoxane hydrochloride|
16312998|NCT00550901|Other|high performance liquid chromatography|
16312999|NCT00550901|Other|laboratory biomarker analysis|
16313000|NCT00550901|Other|mass spectrometry|
16313001|NCT00550901|Other|pharmacological study|
16313002|NCT00550888|Procedure|suture techniques|
16313003|NCT00550875|Biological|Grass pollen allergenic extract (L. perenne-C. dactylon )|Sublingual. 2 drops/daily 1000 DPP/ml 2 years
16313004|NCT00550875|Biological|Grass pollen allergenic extract (L. perenne-C. dactylon )|Sublingual. 2 drops/daily 10000 DPP/ml 2 years
16313005|NCT00550875|Biological|placebo|Sublingual. 2 drops/daily 2 years
16313006|NCT00550862|Drug|INT-747|Once a day (QD) by mouth (PO)
16313007|NCT00550862|Drug|Ursodeoxycholic Acid (URSO)|Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
16313008|NCT00550862|Drug|Placebo|Placebo
16313009|NCT00550849|Drug|RTA 402|5 mg oral capsules
16313010|NCT00550849|Drug|RTA 402|25 mg oral capsules
16313011|NCT00550849|Drug|RTA 402|50 mg oral capsules
16313012|NCT00550836|Biological|panitumumab|Given IV
16313013|NCT00550836|Drug|erlotinib hydrochloride|Given orally
16313014|NCT00550836|Drug|gemcitabine hydrochloride|Given IV
16313015|NCT00550823|Device|Cardiac CT 0BRILLIANT 64|Cardiac CT
16313016|NCT00550810|Drug|Sunitinib (SU011248)|SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
16313017|NCT00550797|Biological|TPI ASM8|Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
16313018|NCT00550797|Biological|placebo|Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
16313019|NCT00550784|Biological|filgrastim|
16313020|NCT00550784|Drug|cisplatin|
16313021|NCT00550784|Drug|cyclophosphamide|
16313022|NCT00550784|Drug|melphalan|
16313023|NCT00550784|Drug|paclitaxel|
16313024|NCT00550784|Drug|topotecan hydrochloride|
16313025|NCT00550784|Genetic|TdT-mediated dUTP nick end labeling assay|
16313026|NCT00550784|Genetic|gene expression analysis|
16313027|NCT00550784|Other|immunohistochemistry staining method|
16313028|NCT00550784|Other|pharmacological study|
16313029|NCT00550784|Procedure|peripheral blood stem cell transplantation|
16313030|NCT00550771|Drug|doxorubicin, cyclophosphamide, paclitaxel, trastuzumab|doxorubicin 60 mg/m^2 IV push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
16313031|NCT00550771|Drug|PLD, cyclophosphamide, trastuzumab, paclitaxel|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
16313032|NCT00550758|Drug|Methachoine|inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)
16313033|NCT00550758|Device|spirometry|spirometry
16313034|NCT00550745|Biological|Zoster Vaccine, Live|single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
16313035|NCT00550745|Biological|Comparator: placebo|single 0.65 mL Placebo injection. 6 month treatment period.
16313036|NCT00550732|Drug|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
16313037|NCT00550693|Device|Chlorhexidine-impregnated foam dressing|Patients during the intervention period had this foam dressing applied around their central venous catheter. This was replaced once a week as recommended by the package insert unless the dressing was soiled, bloody, or fell off.
16313038|NCT00550680|Drug|Methoxy polyethylene glycol-epoetin beta|Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
16313039|NCT00550654|Other|questionnaire administration|Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
16313040|NCT00550654|Radiation|3-dimensional conformal radiation therapy|Conformal radiation therapy improves the ability to spare normal tissues.
16313041|NCT00550654|Radiation|hypofractionated radiation therapy|Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
16313042|NCT00550654|Radiation|image-guided radiation therapy|Image guided radiation therapy targets the specific site of disease.
16313043|NCT00550654|Radiation|tomotherapy|Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.
16313044|NCT00550641|Other|physical therapy|physical therapy in warm pool performing stretching
16313045|NCT00550641|Other|physical therapy|physical therapy in warm pool performing Ai Chi
16313046|NCT00550628|Genetic|DNA methylation analysis|
16313047|NCT00550628|Genetic|fluorescence in situ hybridization|
16313048|NCT00550628|Genetic|gene expression analysis|
16313049|NCT00550628|Genetic|polymerase chain reaction|
16313050|NCT00550628|Genetic|protein expression analysis|
16313051|NCT00550628|Genetic|reverse transcriptase-polymerase chain reaction|
16313052|NCT00550628|Other|diagnostic laboratory biomarker analysis|
16313053|NCT00550628|Other|immunoenzyme technique|
16313054|NCT00550628|Other|immunohistochemistry staining method|
16313055|NCT00550628|Procedure|biopsy|
16313056|NCT00550628|Procedure|therapeutic conventional surgery|
16313057|NCT00550628|Radiation|fludeoxyglucose F 18|
16313058|NCT00550615|Drug|Dasatinib|"Dasatinib will be orally administered once daily for 28 day cycles.
~There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts:
~Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day
~The MTD will be determined in the Phase I portion of this trial."
16313059|NCT00550615|Drug|Dasatinib Maximum Tolerated Dose|An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.
16313060|NCT00550589|Drug|cidofovir|1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.
16313061|NCT00550589|Genetic|DNA methylation analysis|formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation
16313062|NCT00550589|Genetic|gene expression analysis|punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
16313063|NCT00550589|Genetic|polymerase chain reaction|performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
16313064|NCT00550589|Procedure|biopsy|punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation
16313065|NCT00550589|Procedure|histopathologic examination|Evaluated at baseline and 6 weeks after treatment discontinuation
16313066|NCT00550576|Drug|Digibind (Fab)|Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.
16313067|NCT00550563|Dietary Supplement|cholecalciferol|Oral
16313068|NCT00550563|Genetic|polymerase chain reaction|companion study
16313069|NCT00550563|Genetic|polymorphism analysis|companion study
16313070|NCT00550563|Genetic|protein expression analysis|companion study
16313071|NCT00550563|Genetic|reverse transcriptase-polymerase chain reaction|companion study
16313072|NCT00550563|Genetic|western blotting|companion study
16313073|NCT00550563|Other|high performance liquid chromatography|companion study
16313074|NCT00550563|Other|laboratory biomarker analysis|companion study
16313075|NCT00550563|Other|pharmacological study|companion study
16313076|NCT00550563|Procedure|adjuvant therapy|Additional therapy
16313077|NCT00550563|Procedure|immunoscintigraphy|additional testing
16313078|NCT00550550|Drug|Placebo|Placebo sublingual tablet, once daily
16313079|NCT00550550|Biological|SCH 697243|Grass sublingual tablet, once daily
16313080|NCT00550550|Drug|Loratadine Syrup 1 mg/mL Rescue Treatment|Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to <6 years of age and at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
16313081|NCT00550550|Drug|Loratadine 10 mg Rescue Treatment|Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
16313082|NCT00550550|Drug|Olopatadine 0.1% Rescue Treatment|Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis.
16313083|NCT00550550|Drug|Mometasone furoate 50 mcg Rescue Treatment|Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to <12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to <18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray.
16313084|NCT00550550|Drug|Albuterol 108 mcg Rescue Treatment|Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to <18 years with asthma symptoms .
16313085|NCT00550550|Drug|Fluticasone 44 mcg Rescue Treatment|Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to <18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath.
16313086|NCT00550550|Drug|Prednisone 5 mg Rescue Treatment|Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.
16313087|NCT00550537|Drug|bevacizumab|15 mg/m2 given through a vein for every 3 weeks
16313088|NCT00550537|Drug|carboplatin|AUC = 6 given through a vein on day 1 of each cycle.
16313089|NCT00550537|Drug|erlotinib hydrochloride|150 mg taken by mouth daily
16313090|NCT00550537|Drug|paclitaxel|200 mg/m2 given through a vein on day 1 of each cycle.
16313091|NCT00550537|Genetic|gene expression analysis|Blood and tissue collection.
16313092|NCT00550537|Genetic|protein expression analysis|Blood and tissue collection.
16313093|NCT00550537|Genetic|proteomic profiling|Blood and tissue collection.
16313094|NCT00550537|Other|laboratory biomarker analysis|Blood and tissue collection.
16313095|NCT00550524|Biological|Autologous Stem Cell Transplantation|Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 20-25 million cells; in a maximum volume of 4-6 ml. Cells will be injected in the knee joint with a 21 gauge needle.
16313096|NCT00550511|Radiation|Surgeon-performed ultrasound|After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
16313097|NCT00550498|Biological|Autologous Stem Cell Transplantation|Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 3-5 million cells, in a maximum volume of 0.3 ml. Cells will be injected in vitreal at 3.5 millimeter of limbus with a 26 gauge insulin needle.
16313098|NCT00550485|Drug|escitalopram|escitalopram 4 mg
16313099|NCT00550472|Dietary Supplement|probiotics|Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420
16313100|NCT00550459|Drug|Tolvaptan|15-60 mg oral tablet given once a day for 21 days.
16313101|NCT00550459|Drug|Placebo|Placebo tablet given once daily for 21 days
16313102|NCT00550446|Drug|Adalimumab|40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
16313103|NCT00550446|Drug|CP-690-550|15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
16313104|NCT00550446|Drug|CP-690-550|10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
16313105|NCT00550446|Drug|CP-690-550|5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
16313106|NCT00550446|Drug|CP-690,550|3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
16313107|NCT00550446|Drug|CP-690,550|1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
16313108|NCT00550446|Drug|Placebo|Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
16313109|NCT00550433|Device|Bazedoxifene/Conjugated Estrogens|
16313110|NCT00550420|Drug|Rosiglitazone XR|experimental drug
16313111|NCT00550407|Drug|lamotrigine|lamotrigine 100mg/day or 200mg/day
16313112|NCT00550407|Drug|Placebo|placebo once daily
16313113|NCT00550394|Drug|quetiapine and placebo|"Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
~Dosing Schedule and Titration of Topiramate:
~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
16313114|NCT00550394|Drug|Quetiapine and Topiramate|"Dosing Schedule and Titration of Quetiapine:
~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1
~Dosing Schedule and Titration of Topiramate:
~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.
~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
16313115|NCT00550381|Drug|HKI-357|Single-dose capsule
16313116|NCT00550368|Biological|Biological intervention: Enteropathogenic E. coli|5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.
16313117|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
16313118|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
16313119|NCT00550355|Drug|PD 0360324|3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
16313120|NCT00550355|Drug|Placebo|3 doses of Placebo administered over 12 weeks
16313121|NCT00550342|Drug|rituximab|375 mg/m2 intravenously for 4 doses
16313122|NCT00550329|Drug|Glipizide GITS|
16313123|NCT00550303|Drug|bazedoxifene/conjugated estrogens combination|
16313124|NCT00550290|Drug|Cefazolin PostOperatively|Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.
16313125|NCT00550290|Drug|Cefazolin Preoperatively|Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.
16313126|NCT00550277|Drug|LBH589|LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles.
16313127|NCT00550264|Other|Automatic notification of readmissions|The experimental group physicians will receive automatic e-mail notification when a patient is readmitted, including contact information for the readmitting team.
16313128|NCT00550251|Device|Acupressure Wrist Bands (Sea-Bands)|Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
16313129|NCT00550251|Device|Placebo wristbands|Elasticated wrist bands without active bead.
16313130|NCT00550238|Drug|Pimavanserin tartrate (ACP-103)|Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
16313131|NCT00550225|Drug|GSK961081|GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
16313132|NCT00550225|Drug|GSK961081 matching placebo|GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
16313133|NCT00550212|Drug|neratinib|HKI-272, Single-dose capsule and solution
16313134|NCT00550199|Drug|LBH589, Gemcitabine|Phase I dose escalation: LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days.
16313135|NCT00550186|Other|placebo|
16313136|NCT00550186|Drug|Ringers Lactate|
16313137|NCT00550186|Drug|HaemoHES 6%|
16313138|NCT00550173|Drug|pemetrexed|500 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops
16313139|NCT00550173|Drug|erlotinib|150 mg, orally, once daily until progression or unacceptable toxicity develops
16313140|NCT00550160|Drug|Amodiaquine plus Artesunate co-administration|"Under the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
~Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days."
16313141|NCT00550147|Drug|Oros Methylphenidate|"Oros methylphenidate will be titrated over 3 visits according to the following schedule:
~Visit 2 dose of 18 mg QAM
~Visit 3 dose of 36mg QAM
~Visit 4 dose of 54mg QAM."
16313290|NCT00548925|Drug|placebo|BID tablets, 8 weeks of treatment
16313291|NCT00548912|Drug|Spironolactone|
16313449|NCT00547716|Dietary Supplement|Omega-3 Fatty Acids|Omega-3 Fatty Acids - 4 grams per day
16313142|NCT00550147|Drug|quetiapine|"Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1).
~Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg)
~Visit 5 dose of 25mg BID
~Visit 6 dose of 50mg BID
~Visit 7 dose of 100mg BID
~Visit 8 dose of 200mg BID
~Visit 9 dose of 300mg BID
~Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule."
16313143|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
16313144|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
16313145|NCT00550134|Behavioral|Questionnaires, MRI, Comet assay and Cell senescence|Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
16313146|NCT00550121|Drug|vitamin C|
16313147|NCT00550121|Drug|placebo|
16313148|NCT00550108|Other|Ethanol lavage|Ethanol lavage of pancreatic cysts.
16313149|NCT00550095|Drug|valsartan|
16313150|NCT00550056|Behavioral|Narrative Exposure Therapy|Six session of Narrative Exposure Therapy
16313151|NCT00550056|Behavioral|Trauma Counselling|Six sessions of Trauma Counselling, using a variety of skills incl. exposure methods following the skills of the therapist
16313152|NCT00550043|Drug|INCB018424|
16313153|NCT00550043|Drug|Placebo|
16313154|NCT00550030|Radiation|UVB-311nm radiation|UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.
16313155|NCT00550030|Other|No treatment|no UV exposure
16313156|NCT00550017|Drug|Epofolate|Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1 through 4 of a 21-day cycle, until the disease progresses
16313157|NCT00550004|Drug|RP101|190 mg oral tablet
16313158|NCT00550004|Drug|Gemcitabine (1000 mg/m2)|30 minute intravenous infusion
16313159|NCT00549978|Drug|Cilostazol|cilostazol, then cilostazol/probucol
16313160|NCT00549978|Drug|Probucol|Probucol probucol/ cilostazol
16313161|NCT00549965|Drug|Risedronate Sodium|
16313162|NCT00549952|Other|no intervention study|
16313163|NCT00549939|Drug|Alfuzosin|"Form: solution or tablet according to age
~Route: oral
~Dose: daily dose adjusted to body weight"
16313164|NCT00549939|Drug|Placebo|"Form: matching solution or matching tablet according to age
~Route: oral
~Dose: daily dose adjusted to body weight"
16313165|NCT00549926|Drug|Fluvastatin|
16313166|NCT00549926|Drug|Pravastatin|
16313167|NCT00549926|Drug|Pitavastatin|
16313168|NCT00549926|Drug|Atorvastatin|
16313169|NCT00549913|Biological|NeoFuse|immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
16313170|NCT00549913|Procedure|posterolateral spinal fusion with instrumentation|autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
16313171|NCT00549900|Biological|GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)|Intramuscular injection, 3 doses
16313172|NCT00549887|Drug|Analog or Human Insulin|prescribed in accordance with usual clinical practice
16313173|NCT00549874|Drug|Rosiglitazone|oral 8 mg/once daily for 6 months
16313174|NCT00549874|Drug|Glyburide|20 mg/ once daily for 6 months
16313175|NCT00549861|Procedure|Cardiac Magnetic Resonance study|Cardiac MRI study
16313176|NCT00549848|Drug|Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine|See Detailed Description section for details of treatment interventions.
16313177|NCT00549848|Drug|Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib|See Detailed Description section for details of treatment interventions.
16313178|NCT00549835|Procedure|Real Acupuncture|
16313179|NCT00549835|Procedure|Sham Acupuncture|"Sham needles are developed to exclude sham effect and to prove real acupuncture efficacy. We will use specifically retractable Park Sham Device (AcuPrime, Exeter, UK) for control group. Because this sham device gives the impression of insertion with telescopic needle body and some pricking sensation with a bunt needle tip. It is a valid control for many acupuncture trials as it doesn't penetrate skin and doesn't create active stimulation as much as real needles or acupressure. To avoid unnecessary stimulation of penetrating skin in this population, we plan to use non-penetrating sham device rather than penetrating non-acupuncture point with real needles as control intervention.
~All other procedures will be same as Real Acupuncture group except using non-penetrating sham needles on non-acupuncture points. After final session, we will ask all subjects in both groups which form of treatment each subject believe to have during study and will analyze blinding credibility."
16313180|NCT00549822|Drug|Letrozole|Treatment is intermittent with possible breaks between each 28 day treatment cycle if CA 15-3 or CA 27.29 level that has decreased by at least 50% of that individual patient's baseline or peak level on firstline letrozole or anastrozole therapy or has decreased into the normal reference range per institutional parameters. Letrozole or anastrozole therapy will be interrupted until CA 15-3 or CA 27.29 levels rise by at least 25% above trough CA 15-3 or CA 27.29 level. If the trough level is in the normal reference range then the CA 15-3 or CA 27.29 must rise into the normal reference range.
16313181|NCT00549809|Procedure|Intermittent mandatory ventilation (IMV) and synchronous IMV|Patients divided to receive two different modes of mechanical ventilation.
16313182|NCT00549796|Other|Percutaneous coronary intervention (PCI)|Patients undergo routine, clinically indicated PCI
16313183|NCT00549783|Biological|Botulinum Toxin Type A 900kD|"The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit."
16313335|NCT00548639|Other|Statin Choice Decision Aid|Paper based instrument with pictures indicating level of risk.
16313336|NCT00548639|Other|Control Pamphlet|ADA Diabetes Sheet
16313184|NCT00549783|Biological|Placebo|"The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit."
16313185|NCT00549770|Drug|LCZ696|
16313186|NCT00549770|Drug|Valsartan|
16313187|NCT00549770|Drug|AHU377|
16313188|NCT00549770|Drug|Placebo|
16313189|NCT00549757|Drug|Aliskiren|Aliskiren 150 mg film-coated tablets
16313190|NCT00549757|Drug|Placebo|Placebo to match aliskiren 150 mg film-coated tablets
16313191|NCT00549744|Drug|GSK256066|
16313192|NCT00549718|Drug|Lurasidone HCl|Once daily
16313193|NCT00549692|Drug|Omega-3 fatty acid ethylester90|Dosage form :1g soft capsule Dosage : two capsules, twice a day.
16313194|NCT00549679|Drug|GSK256066|PDE4 inhibitor
16313195|NCT00549679|Drug|Placebo|Placebo
16313196|NCT00549666|Drug|Lurasidone 40 mg|Lurasidone 40 mg days 12-21 once daily
16313197|NCT00549666|Drug|Placebo 40 mg|Placebo 40 mg once daily during treatment period
16313198|NCT00549666|Drug|Ortho Tri-Cyclen|Ortho Tri-Cyclen during 28-day lead in period
16313199|NCT00549653|Drug|GW856553|
16313200|NCT00549640|Drug|Methylphenidate|54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day).
16313201|NCT00549640|Drug|Placebo|non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)
16313202|NCT00549627|Device|Pediguard|PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.
16313203|NCT00549614|Drug|acipimox|capsule, 250 mg, 4 times daily for 28 days
16313204|NCT00549614|Drug|placebo|capsule, 250 mg, 4 times daily for 28 days
16313205|NCT00549601|Drug|Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
16313206|NCT00549601|Drug|Rivastigmine patch (9.5 mg/day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
16313207|NCT00549601|Drug|Rivastigmine capsules (6 mg to 12 mg/day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
16313208|NCT00549588|Other|After-sun-lotion with DNA repair enzymes|2 mg/cm2 immediately after UV exposure
16313209|NCT00549588|Other|SPF30 sunscreen|2 mg/cm2 2o min before UV exposure
16313210|NCT00549588|Other|Placebo after-sun-lotion|2mg/cm2 immediately after UV exposure
16313211|NCT00549588|Other|Intervention: none (only UV)|
16313212|NCT00549575|Drug|L ARG|Patients received 14 g/day of L-arginine (90 mL syrup, Veyron France Laboratories).
16313213|NCT00549575|Drug|Placebo|After double blind randomization, patients received a placebo.
16313214|NCT00549562|Drug|Paliperidone ER|Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
16313215|NCT00549549|Drug|Indomethacin|indomethacin 50 mg three times a day (TID) for 8 days.
16313216|NCT00549549|Drug|Celecoxib|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.
16313217|NCT00549549|Drug|Celecoxib|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.
16313218|NCT00549549|Drug|Celecoxib|Celecoxib 50 mg two times a day (BID) for 8 days
16313219|NCT00549536|Dietary Supplement|tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)|1500 mg of elemental calcium per day.
16313220|NCT00549523|Drug|Placebo|Capsules containing 0 mg bid (placebo)
16313221|NCT00549523|Drug|Low Dose|Capsules containing 400 mg bid of L. frutescens.
16313222|NCT00549523|Drug|Mid Dose|Capsules containing 800 mg bid of L. frutescens.
16313223|NCT00549523|Drug|High Dose|Capsules containing 1200 mg bid of L. frutescens.
16313224|NCT00549510|Drug|COREG CR and lisinopril (FDC)|
16313225|NCT00549497|Drug|GW870086X|
16313226|NCT00549471|Other|physiotherapy|CG children will undergo a program of intensive physiotherapy
16313227|NCT00549471|Other|Botulinum Toxin A and physiotherapy|BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis, while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg.
16313228|NCT00549458|Behavioral|Pilates|The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.
16313229|NCT00549458|Procedure|Pelvic muscle rehabilitation therapy|The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.
16313230|NCT00549445|Drug|Azithromycin|250 mg daily
16313231|NCT00549445|Drug|Placebo|Daily
16313448|NCT00547729|Device|HeartPOD™ System|HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.
16313232|NCT00549432|Device|TALENT Enhanced LPS Endoluminal Stent-Graft System|roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
16313233|NCT00549419|Drug|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine|The Control group will be assessed using the standard care of traditional vital signs
16313234|NCT00549419|Drug|Goal-directed hemodynamic therapy|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
16313235|NCT00549419|Drug|Standard of care|Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
16313236|NCT00549406|Procedure|computerized visual training|two one-hour training sessions per week, for five consecutive weeks
16313237|NCT00549406|Procedure|computerized word puzzles|two one-hour sessions per week, for five consecutive weeks
16313238|NCT00549406|Procedure|video-game based visual training|two one-hour training sessions per week, for five consecutive weeks
16313239|NCT00549393|Drug|2% Chlorhexidine gluconate cloth|Daily bathing
16313240|NCT00549380|Device|Endologix, Inc. Endoluminal Technology|Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
16313241|NCT00549367|Behavioral|Nutrition Counselling|Clients will receive ongoing nutrition assessment and dietary counselling. The intervention arm will receive all baseline assessments and individual nutritional assessment, counselling and nutrition management plans using standards of practice
16313242|NCT00549354|Device|Endoluminal Graft|
16313243|NCT00549341|Drug|Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin|100U vials, doses ranged from 50U-200U, single injection.
16313244|NCT00549341|Other|Physiologic saline|Single injection.
16313245|NCT00549328|Drug|Pazopanib (GW786034)|Pazopanib monotherapy
16313246|NCT00549315|Device|Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter|VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
16313247|NCT00549302|Drug|tadalafil|20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).
16313248|NCT00549302|Drug|tadalafil|40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.
16313249|NCT00549289|Drug|cyclosporine A|
16313250|NCT00549263|Drug|SB797620|
16313251|NCT00549237|Dietary Supplement|Glucose load (Nutricia)|Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
16313252|NCT00549237|Other|Post operative early enteral feeding|Enteral feeding starting 6 hours post surgery
16313253|NCT00549211|Drug|GSK557296|
16313254|NCT00549198|Drug|Abacavir/lamivudine and efavirenz|
16313255|NCT00549198|Drug|Tenofovir/Emtricitabine and efavirenz|
16313256|NCT00549185|Drug|SAR3419|Intravenous infusion
16313257|NCT00549172|Procedure|Operative (partial arthroscopy)|Partial arthroscopic resection of degenerative rupture of the medial meniscus
16313258|NCT00549172|Procedure|Conservative (diagnostic arthroscopy)|Diagnostic arthroscopy
16313259|NCT00549159|Device|Thermal Balloon Endometrial Ablation|Thermal balloon endometrial ablation
16313260|NCT00549159|Device|Transcervical Resection of the Endometrium|Transcervical resection of the endometrium
16313261|NCT00549146|Drug|fluticasone propionate/salmeterol 250/50 DISKUS combination product|
16313262|NCT00549146|Drug|fluticasone propionate DISKUS 500mcg|
16313263|NCT00549133|Drug|Irbesartan|
16313264|NCT00549120|Drug|Propranolol|40 mg tablets
16313265|NCT00549120|Drug|Salbutamol|Metered dose inhaler (600 μg)
16313266|NCT00549120|Drug|Ipratropium|Metered dose inhaler (40 μg)
16313267|NCT00549120|Drug|Placebo|Placebo for propranolol tablets
16313268|NCT00549107|Drug|Levosimendan|
16313269|NCT00549107|Drug|Milrinone|
16313270|NCT00549081|Dietary Supplement|DHEA|oral DHEA tablets 75 mg daily
16313271|NCT00549068|Drug|Risedronate Sodium (Actonel)|
16313272|NCT00549055|Drug|Macugen|Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
16313273|NCT00549042|Drug|OROS hydromorphone|hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
16313274|NCT00549042|Drug|Placebo|Placebo
16313275|NCT00549029|Genetic|DNA|withdraw 5~10mL blood from vein only once during the whole design
16313276|NCT00549016|Device|PTPE Encapsulation of Nitinol Stents|Both common femoral arteries (CFAs) are surgically exposed to allow bilateral access of diagnostic and therapeutic devices. The endoluminal stent graft is then deployed in accordance with the Instructions for Use.
16313277|NCT00549003|Device|Rapid Diagnostic Test for P. falciparum malaria|
16313278|NCT00548990|Behavioral|cardiovascular exercise training|
16313279|NCT00548990|Behavioral|flexibility/balance control|
16313280|NCT00548977|Other|Drawing blood to study genetic polymorphism|
16313281|NCT00548964|Drug|Lithium|600-900mg of Li carbonate
16313282|NCT00548964|Drug|Ketamine|0.5mg/kg of ketamine
16313283|NCT00548951|Other|Snoezelen Room|Session in a Snoezelen room once per week for 12 weeks
16313284|NCT00548951|Other|Snoezelen Room|Session in a Snoezelen room three times per week for 12 weeks
16313285|NCT00548951|Other|Control|Receive no sessions in a Snoezelen Room.
16313286|NCT00548938|Drug|Gliadel wafer|Implanted at surgery
16313287|NCT00548938|Drug|Temozolomide|During External Beam Radiation
16313288|NCT00548938|Radiation|External Beam Radiation Therapy|60 Gy
16313289|NCT00548925|Drug|ABT-894|6 mg BID tablets, 8 weeks of treatment
16313450|NCT00547716|Drug|Placebo comparator|
16313292|NCT00548899|Drug|Nexavar (Sorafenib)|Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day
16313293|NCT00548886|Drug|Epinephrine|We will follow the protocol outlined by Ackerman et al. known as the Mayo protocol4 which is currently used routinely in our electrophysiology laboratory. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes and a twelve-lead electrocardiogram is obtained at time=0 minutes, 5 minutes, and 10 minutes. The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes and the electrocardiogram repeated. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes and electrocardiogram obtained. The epinephrine infusion is then discontinued and measurements are obtained at five minutes and ten minutes after stopping the epinephrine infusion. The total time of procedure will be 35 minutes.
16313294|NCT00548860|Drug|Ferric Carboxymaltose|
16313295|NCT00548860|Drug|Standard Medical Care (SMC)|
16313296|NCT00548847|Biological|GM-CSF|Dosing schedule: 250 mcg/m² subcutaneously Mon-Wed-Fri. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
16313297|NCT00548847|Biological|Interferon-α-2b|Dosing schedule: 1.5 mcg/kg subcutaneously Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
16313298|NCT00548834|Drug|CDP870|
16313299|NCT00548821|Drug|Cisplatin|
16313300|NCT00548808|Drug|Insulin lispro low mixture|Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
16313301|NCT00548808|Drug|Insulin glargine|Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
16313302|NCT00548808|Drug|Insulin lispro|Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
16313303|NCT00548782|Other|Paleolithic diet|diet
16313304|NCT00548782|Other|ADA ( American Diabetes Association) recommended diet|diet
16313305|NCT00548769|Drug|Formulation A|Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.
16313306|NCT00548769|Drug|Formulation B|Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
16313307|NCT00548769|Drug|Formulation C|Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.
16313308|NCT00548769|Drug|Formulation D|Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
16313309|NCT00548756|Procedure|Whole Brain Radiation Therapy|Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.
16313310|NCT00548756|Other|Observation|Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.
16313311|NCT00548756|Behavioral|Questionnaire|Questionnaire taking 40 minutes to complete.
16313312|NCT00548743|Behavioral|Screening and follow up|Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
16313313|NCT00548743|Behavioral|Usual care|usual care for identification and management of postpartum depression
16313314|NCT00548730|Procedure|Bronchoscopy|The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions.
16313315|NCT00548717|Drug|Sirolimus|
16313316|NCT00548717|Drug|Mycophenolate mofetil|
16313317|NCT00548717|Drug|Bortezomib|
16313318|NCT00548704|Drug|Dexrazoxane|
16313319|NCT00548691|Drug|Ferric Carboxymaltose|
16313320|NCT00548691|Drug|Standard Medical Care (SMC)|
16313321|NCT00548678|Drug|intravenous diclofenac sodium (DIC075V)|intravenous diclofenac sodium
16313322|NCT00548678|Drug|ketorolac|intravenous ketorolac
16313323|NCT00548678|Drug|oral diclofenac (Cataflam)|oral diclofenac (Cataflam)
16313324|NCT00548678|Drug|aspirin|oral aspirin
16313325|NCT00548665|Device|Carotid ultrasound for plaque screening|Carotid ultrasound for plaque screening
16313326|NCT00548665|Behavioral|Brief advice for smoking cessation|We will use the 5A's heuristic (Ask about smoking, Advise on cessation, Assess willingness to change, and for those willing to make quit attempt: Assist with attempt to quit, and Arrange for follow-up) and the gold standard for brief smoking cessation advice. At each visit, smokers will receive smoking cessation counseling and nicotine replacement therapy, similar to the experimental group.
16313327|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
16313328|NCT00548652|Behavioral|medical crisis councelling|group counselling sessions
16313329|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
16313330|NCT00548652|Drug|methyphenidate|methyphenidate will be used to treat apathy dose 10mg bid
16313331|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
16313332|NCT00548652|Drug|methyphenidate|methyphenidate will be used to treat apathy dose 10mg bid
16313333|NCT00548652|Behavioral|medical crisis councelling|group counselling sessions
16313334|NCT00548652|Behavioral|MOVE|is a VA based multidesciplinary weight loss intervention
16313807|NCT00545311|Drug|Placebo|
16313337|NCT00548626|Procedure|Single needle|Patients will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
16313338|NCT00548626|Procedure|Multiple needle|Patients will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
16313339|NCT00548613|Biological|MESENDO|Intracoronary transplantation of autologous stem cells via balloon catheter
16313340|NCT00548613|Biological|MESENDO|Intracardiac transplantation of autologous stem cells via direct injection
16313341|NCT00548600|Procedure|Iridium Implant|Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.
16313342|NCT00548600|Radiation|Standard external beam irradiation|Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.
16313343|NCT00548587|Drug|E5555|
16313344|NCT00548587|Drug|Placebo|
16313345|NCT00548574|Drug|SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|
16313346|NCT00548574|Drug|Mesalazine|
16313347|NCT00548561|Drug|Dexrazoxane|
16313348|NCT00548548|Drug|Bevacizumab|Intravenous bevacizumab 7.5 mg/kg once every 3 weeks, given until disease progression or unmanageable toxicity.
16313349|NCT00548548|Drug|Capecitabine|Oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, given until disease progression or unmanageable toxicity.
16313350|NCT00548548|Drug|Cisplatin|Cisplatin 80 mg/m˄2 as a 2 hr intravenous infusion with hyper-hydration and pre-medication (steroids and anti-emetics), given every 3 weeks for a maximum of 6 cycles or until disease progression or unmanageable toxicity.
16313351|NCT00548548|Drug|Placebo|Intravenous placebo every 3 weeks, given until disease progression or unmanageable toxicity.
16313352|NCT00548548|Drug|5-fluorouracil|For participants with difficulty swallowing, malabsorption, or other conditions that could affect intake of oral capecitabine medication, 5-fluorouracil was administered instead, at a dose of 800 mg/m˄2/day as a continuous intravenous infusion over 5 days (days 1 to 5 of each cycle), every 3 weeks.
16313353|NCT00548535|Procedure|Reliability of complication assessment|
16313354|NCT00548509|Drug|Menatetrenone (Vitamin K2)|
16313355|NCT00548496|Drug|SB-751689|SB-751689
16313356|NCT00548496|Other|Placebo|Placebo to match
16313357|NCT00548483|Drug|dexamethasone (Oradexon, Nederland)|dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2
16313358|NCT00548470|Drug|Varenicline|Varenicline 1-2 mg/day
16313359|NCT00548444|Biological|MVA85A|Vaccine. Dose: 1 x 10^8 plaque-forming units (pfu) given by intradermal injection into the deltoid region of the upper arm.
16313360|NCT00548444|Other|Deuterated glucose infusion|6,6D2-glucose given as a timed intravenous infusion. The total dose of deuterated glucose will be 1g/kg volunteer body weight (up to a maximum of 60g).
16313361|NCT00548431|Drug|6-mercaptopurine|Standard dose 25 mg/m^2/day. Can be increased up to 75 mg/m^2/day if the myelosuppression is acceptable (ANC>0.5 T-count >50)
16313362|NCT00548418|Drug|Topotecan|
16313363|NCT00548418|Drug|Cisplatin|
16313364|NCT00548418|Drug|Bevacizumab|
16313365|NCT00548405|Biological|Alemtuzumab 12 mg|Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
16313366|NCT00548405|Biological|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
16313367|NCT00548405|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
16313368|NCT00548379|Drug|vitamin D|vitamin D 100,000 units once in 3 months
16313369|NCT00548379|Drug|placebo|olive oil 1ml
16313370|NCT00548366|Other|Sodium restriction|4 gram sodium diet
16313371|NCT00548366|Other|Sodium restriction|2 gram sodium diet
16313372|NCT00548353|Drug|MK3207|M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).
16313373|NCT00548353|Drug|Comparator: Placebo (unspecified)|M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).
16313374|NCT00548340|Drug|VEC-162 20 mg|20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
16313375|NCT00548340|Drug|Placebo|Placebo capsules, PO daily for five weeks
16313376|NCT00548340|Drug|VEC-162 50 mg|50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
16313377|NCT00548327|Drug|Atomoxetine|Comparison between Atomoxetine and Placebo
16313378|NCT00548327|Procedure|Functional magnetic resonance imaging|Comparison between Atomoxetine and Placebo arms
16313379|NCT00548327|Procedure|Neuropsychological Testing|Comparison between Atomoxetine and Placebo arms
16313380|NCT00548327|Drug|Placebo|25 mg, 40 mg, 60 mg and 80 mg Atomoxetine Placebo
16313381|NCT00548314|Other|dermal matrix|1mm thickness matrix composed of collagen-elastin hydrolosate
16313382|NCT00548314|Procedure|Split skin graft|
16313383|NCT00548314|Device|VAC therapy (KCI)|VAC therapy for 3-5 days 125mmHg
16313384|NCT00548301|Drug|cyclosporine|
16313385|NCT00548288|Drug|pamidronate|
16313386|NCT00548275|Behavioral|Enhanced Sexual Risk Management|management of sexual risk
16313387|NCT00548275|Behavioral|Standard Sexual Risk Management|management of sexual risk
16313388|NCT00548262|Drug|Anidulafungin|All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.
16313389|NCT00548262|Drug|Voriconazole|Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).
16313390|NCT00548249|Device|Standard Bicarbonate Solution|Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
16313391|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
16313392|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
16313393|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
16313394|NCT00548249|Drug|Soluble Ferric Pyrophosphate|Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
16313395|NCT00548236|Behavioral|Telephone-Based exercise intervention|Exercise counselling offered via telephone calls
16313396|NCT00548223|Drug|Dengzhan Shengmai capsule|Capsule, 0.18g, 2#, Bid*1year
16313397|NCT00548223|Drug|placebo|Capsule, 0.18g, 2#, Bid*1year
16313398|NCT00548197|Drug|Bevacizumab|one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
16313399|NCT00548184|Drug|Lapatinib|Monoclonal Antibody
16313400|NCT00548184|Drug|Trastuzumab|Monoclonal Antibody
16313401|NCT00548184|Drug|Endocrine|Hormonal Therapy
16313402|NCT00548171|Biological|Boostrix™|Intramuscular injection, 1 dose
16313403|NCT00548145|Drug|Pitavastatin|2 mg by orally/day Duration: 12 months
16313404|NCT00548145|Drug|cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)|duration: 12 months
16313405|NCT00548132|Device|Chlorhexidine-impregnated foam dressing|Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.
16313406|NCT00548119|Biological|NeoCart|autologous tissue implant
16313407|NCT00548119|Procedure|microfracture|microfracture
16313408|NCT00548106|Dietary Supplement|partially hydrolyzed whey|Total infant feeding by study formula.
16313409|NCT00548106|Dietary Supplement|Nan HA|Total infant diet by study formula.
16313410|NCT00548093|Drug|PF-00299804|PF-00299804 orally at 45 mg daily, on continuous schedule
16313411|NCT00548093|Drug|PF-00299804|PF-00299804 orally at 45 mg daily, on continuous schedule
16313412|NCT00548080|Drug|MK0991, caspofungin acetate / Duration of Treatment:|
16313413|NCT00548067|Drug|Valsartan/hydrochlorothiazide (HCTZ)|
16313414|NCT00548067|Drug|Valsartan/amlodipine|
16313415|NCT00548067|Drug|Amlodipine/hydrochlorothiazide(HCTZ)|
16313416|NCT00548067|Drug|Valsartan/amlodipine/hydrochlorothiazide(HCTZ)|
16313417|NCT00548054|Biological|Bivalent killed oral cholera vaccine|Oral, 1.5 ml, given 2 times at least 14 days apart
16313418|NCT00548054|Biological|Killed Escherichia coli K12 placebo|oral, 1.5 ml per dose
16313419|NCT00548041|Other|HIV test by oral swab|Eligible subjects underwent rapid HIV testing by oral swab.
16313420|NCT00548015|Behavioral|state-of-the art strategy and extented strategy|state-of-the art: education, reminders, performance feedback, extented:state-of-the art and coaching ward manager,modeling of informal leaders, norm and target setting
16313421|NCT00548002|Drug|trovafloxacin and levofloxacin|Trovafloxacin: <60 kg 200 mg iv/orally once daily and >60 kg 300 mg iv/orally once daily Levofloxacin: < 60 kg 500 mg iv/orally once daily and >60 kg 500 mg iv/orally bid
16313422|NCT00547989|Drug|standard anaesthesia (bupivacaine)|Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
16313423|NCT00547989|Drug|additional pvb (ropivacaine) and elastomeric disposable infusion pump|Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
16313424|NCT00547989|Drug|additional pvb (ropivacaine)|Patients in group 1 will receive PVB with ropivacaine
16313425|NCT00547976|Drug|[C-11]PBR28|
16313426|NCT00547963|Behavioral|brief counseling|baseline assessment + two 40 minute sessions of brief counseling
16313427|NCT00547950|Drug|:Deng Zhan Sheng Mai Capsule|capsule，0.18g，2＃，po，Bid*1year.
16313428|NCT00547937|Device|nasal continuous positive airway pressure (CPAP) therapy|Nocturnal ventilation through a nasal mask to avoid sleep apneas
16313429|NCT00547924|Behavioral|Transoesophageal echocardiography|Transoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion
16313430|NCT00547911|Drug|Droxidopa|
16313431|NCT00547911|Drug|Carbidopa|
16313432|NCT00547911|Drug|Entacapone|
16313433|NCT00547898|Drug|Crofelemer 125 mg|Crofelemer 125 mg
16313434|NCT00547898|Drug|Crofelemer 250 mg|Crofelemer 250 mg
16313435|NCT00547898|Drug|Crofelemer 500 mg|Crofelemer 500 mg
16313436|NCT00547898|Drug|Placebo|Placebo
16313437|NCT00547885|Drug|Dihydrocodeine|"Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo short action
~Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo short action
~Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo short action
~Group 4: 2 placebo for long acting + up to 4*30 mg dihydrocodeine short acting
~Group 5: 3 placebo for long acting + up to 6*30 mg dihydrocodeine short acting
~Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting"
16313438|NCT00547872|Procedure|exercise testing - coronary angiography - revascularization|Those patients with a positive exercise ECG test will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery
16313439|NCT00547846|Drug|PDC-748|
16313440|NCT00547820|Other|placebo|
16313441|NCT00547820|Device|Urinary sensor|
16313442|NCT00547807|Other|Non-nutritive sucking|Non-nutritive sucking is applied by using a gloved finger
16313443|NCT00547807|Other|Swaddling|Swaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted
16313444|NCT00547781|Procedure|PGD|
16313445|NCT00547768|Drug|Fexofenadine HCI|
16313446|NCT00547742|Procedure|PET/CT Scan|
16313447|NCT00547742|Procedure|phlebotomy|
16313451|NCT00547703|Drug|Nortriptyline|Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
16313452|NCT00547703|Drug|Placebo|An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
16313453|NCT00547690|Other|Acupuncture and Strengthening|Acupuncture and strengthening
16313454|NCT00547690|Other|Strengthening Alone|Strengthening training program
16313455|NCT00547677|Radiation|stereotactic radiosurgery|
16313456|NCT00547664|Drug|Hylenex recombinant , morphine, saline|Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.
16313457|NCT00547664|Other|Saline|Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
16313458|NCT00547651|Drug|Amrubicin|Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
16313459|NCT00547651|Drug|Topotecan|Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
16313460|NCT00547638|Device|cyanoacrylate with pressure sensitive mesh|Topical Skin Adhesive
16313461|NCT00547638|Device|cyanoacrylate|Topical Skin Adhesive
16313462|NCT00547625|Drug|tadalafil|Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
16313463|NCT00547625|Drug|placebo|Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
16313464|NCT00547612|Other|high performance liquid chromatography|
16313465|NCT00547612|Other|pharmacological study|
16313466|NCT00547612|Radiation|[18F]-labeled substance P antagonist receptor quantifier|
16313467|NCT00547599|Drug|tadalafil|20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
16313468|NCT00547586|Drug|N-methylnaltrexone bromide (MOA-728)|Oral
16313469|NCT00547586|Other|placebo|placebo
16313470|NCT00547573|Drug|tadalafil|10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
16313471|NCT00547573|Drug|tadalafil|20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
16313472|NCT00547573|Drug|placebo|placebo tablet taken by mouth as needed for 12 weeks not more than once a day
16313473|NCT00547560|Drug|GSI-953|Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.
16313474|NCT00547547|Dietary Supplement|high-selenium Brassica juncea|Dose Level A: 3200 mcg orally day -7 through duration of treatment. Dose Level B: 4800 mcg orally day -7 through duration of treatment. Dose Level C: 6400 mcg orally day -7 through duration of treatment. Dose Level D: 7200 mcg orally day -7 through duration of treatment. Dose Level E: 8000 mcg orally day -7 through duration of treatment.
16313475|NCT00547547|Drug|capecitabine|Dose Level 1: 750 mg/m2, 2x daily x 14 days every 21 days. Dose Level 1.5: 850 mg/m2, 2x daily x 14 days every 21 days. Dose Level 2: 1000 mg/m2, 2x daily x 14 days every 21 days.
16313476|NCT00547547|Drug|irinotecan hydrochloride|Dose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days.
16313477|NCT00547534|Drug|bortezomib|1.3 mg/m^2 on days 1, 4, 8, 11
16313478|NCT00547534|Drug|bendamustine|90 mg/m^2 days 1 and 4
16313479|NCT00547534|Drug|rituximab|375 mg/m^2 day 1
16313480|NCT00547521|Drug|abatacept|solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
16313481|NCT00547521|Drug|Methotrexate (MTX)|Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
16313482|NCT00547508|Drug|tadalafil|10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313483|NCT00547508|Drug|placebo|Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313484|NCT00547508|Drug|tadalafil|20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313485|NCT00547508|Drug|tadalafil|20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313486|NCT00547508|Drug|tadalafil|10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313487|NCT00547508|Drug|placebo|Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
16313488|NCT00547495|Drug|tadalafil|5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
16313489|NCT00547495|Drug|placebo|placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
16313490|NCT00547495|Drug|tadalafil|10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
16313491|NCT00547495|Drug|tadalafil|20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
16313492|NCT00547482|Device|TANTALUS(TM) System|"All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the Treatment Group or Control Group after surgery at Week 1, Visit 5 (device activation)."
16313493|NCT00547469|Drug|DDP733|
16313494|NCT00547456|Drug|Oxygen|Oxygen 2-3L Nasal cannula
16313495|NCT00547443|Drug|carboplatin|Given IV
16313496|NCT00547443|Drug|paclitaxel|Given IV
16313497|NCT00547443|Drug|sorafenib tosylate|Given orally
16313498|NCT00547443|Radiation|radiation therapy|Given 5 days a week for 7.5 weeks
16313499|NCT00547417|Drug|tadalafil|20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
16313500|NCT00547404|Drug|P276-00|IV drug infusion over a period of 30 min on day 1,4,8 and 11 in21 day cycle for 6 cycles
16313501|NCT00547391|Procedure|Tonsillectomy|Tonsillectomy under general anesthesia as a day surgery using diathermy or blunt dissection. Follow up started from the day of surgery.
16313502|NCT00547391|Other|no intervention|No intervention (controls). Follow up started from the day of randomization.
16313503|NCT00547378|Device|InterStim|
16313504|NCT00547378|Drug|Standard Medical Therapy|Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg
16313505|NCT00547365|Biological|Human immune globulin intravenous (IGIV)|Analyze the therapeutic potential of human immune globulin intravenous (IGIV) when given to patients with cardiac-associated AL amyloidosis
16313506|NCT00547352|Drug|tadalafil|20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.
16313507|NCT00547352|Drug|sildenafil|Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.
16313508|NCT00547339|Radiation|stereotactic body radiation therapy|
16313509|NCT00547326|Procedure|treated with osteopatic cranial techniques|treated with osteopatic cranial techniques
16313510|NCT00547326|Procedure|Treatment with placebo|Treatment with placebo
16313511|NCT00547300|Drug|Metoprolol ER|Metoprolol ER once daily, oral administration
16313512|NCT00547300|Drug|Nebivolol|Nebivolol once daily, oral administration
16313513|NCT00547287|Drug|tadalafil|20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
16313514|NCT00547287|Drug|sildenafil|Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
16313515|NCT00547274|Drug|MK0767|
16313516|NCT00547261|Drug|SSR97225|every 3 weeks
16313517|NCT00547248|Biological|Synflorix|Intramuscular injection, 1 dose
16313518|NCT00547248|Biological|Tritanrix-HepB|Intramuscular injection, 1 dose
16313519|NCT00547248|Biological|Hiberix|Reconstituted with Tritanrix-Hep B before injection
16313520|NCT00547248|Biological|Polio Sabin|Oral, 1 dose
16313521|NCT00547248|Biological|Poliorix|Intramuscular injection, 1 dose
16313522|NCT00547248|Biological|Prevenar (Wyeth)|Intramuscular injection, 1 dose
16313523|NCT00547235|Biological|therapeutic allogeneic lymphocytes|
16313524|NCT00547235|Procedure|allogeneic bone marrow transplantation|
16313525|NCT00547235|Radiation|total-body irradiation|
16313526|NCT00547209|Drug|air|60% air combined with 40% oxygen for ventilation
16313527|NCT00547209|Drug|Nitrous oxide|60% nitrous oxide combined with 40% oxygen for ventilation
16313528|NCT00547196|Biological|filgrastim|
16313529|NCT00547196|Drug|busulfan|
16313530|NCT00547196|Drug|cyclophosphamide|
16313531|NCT00547196|Drug|cyclosporine|
16313532|NCT00547196|Drug|fludarabine phosphate|
16313533|NCT00547196|Drug|melphalan|
16313534|NCT00547196|Drug|mycophenolate mofetil|
16313535|NCT00547196|Procedure|allogeneic hematopoietic stem cell transplantation|
16313536|NCT00547196|Procedure|umbilical cord blood transplantation|
16313537|NCT00547196|Radiation|total-body irradiation|
16313538|NCT00547183|Drug|tadalafil|2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
16313539|NCT00547183|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
16313540|NCT00547183|Drug|placebo|Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
16313541|NCT00547170|Drug|Doxycycline pre-operatively|"Two capsules of Doxycycline 100 mg before vacuum aspiration Placebo 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)"
16313542|NCT00547170|Drug|Doxycycline post-operatively|"Two capsules of placebo 100 mg before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)"
16313543|NCT00547157|Drug|Panitumumab|Arm 2 consists of panitmumab plus RT
16313544|NCT00547157|Drug|Cisplatin|Cisplatin
16313545|NCT00547144|Drug|Gemcitabine|1000 mg/m2 intravenoulsy once a week according to protocol schedule
16313546|NCT00547144|Procedure|Dendritic Cell Immunotherapy|The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
16313547|NCT00547131|Drug|temozolomide|
16313548|NCT00547131|Other|laboratory biomarker analysis|
16313549|NCT00547131|Other|liquid chromatography|
16313550|NCT00547131|Other|mass spectrometry|
16313551|NCT00547131|Other|pharmacological study|
16313552|NCT00547131|Procedure|conventional surgery|
16313553|NCT00547131|Radiation|stereotactic radiosurgery|
16313554|NCT00547118|Drug|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
16313555|NCT00547118|Drug|Placebo|One placebo tablet given 1 time per day for 112 days.
16313556|NCT00547105|Drug|Erlotinib|Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
16313557|NCT00547105|Radiation|SBRT|SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
16313558|NCT00547092|Drug|tadalafil|10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
16313559|NCT00547092|Drug|sildenafil|25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
16313560|NCT00547066|Biological|veltuzumab|hA20 will be administered intravenously in two doses over two weeks
16313561|NCT00547053|Drug|Amiloride Solution for Inhalation|4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months
16313562|NCT00547040|Other|no intervention|no intervention
16313877|NCT00544830|Drug|Leuprolide Acetate|Given via injection
16313563|NCT00547027|Behavioral|print-based physical activity intervention|individually-based, print-based physical activity intervention
16313564|NCT00547027|Behavioral|usual care|print-based materials of nutritional information
16313565|NCT00547014|Drug|Placebo Comparator: Cohort 1 Placebo|Drug: placebo for cohort 1 as single dose
16313566|NCT00547014|Drug|52364 3 mg|3 mg capsule single dose administered orally as a single dose
16313567|NCT00547014|Drug|Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo|Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose
16313568|NCT00547014|Drug|52364 10 mg|Drug: 52364 30 mg capsule as a single dose
16313569|NCT00547014|Drug|52364 30 mg|Drug: 52364 30 mg capsule administered as a single dose
16313570|NCT00547014|Drug|52364 100 mg|Drug 52364 100 mg capsule administered as a single dose
16313571|NCT00547014|Drug|52364 1 mg|1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
16313572|NCT00547001|Drug|Estradiol|1mg during stabilization & then a taper to 0.75mg, 0.5mg, 0.25mg, 0.125mg.
16313573|NCT00546988|Biological|allogeneic stem cell transplant|
16313574|NCT00546975|Dietary Supplement|Resource Support®|
16313575|NCT00546975|Dietary Supplement|Resource Protein®|
16313576|NCT00546975|Dietary Supplement|Placebo|
16313577|NCT00546949|Procedure|Minimal invasive decompression|foraminotomy, laminotomy, microscopic decompression
16313578|NCT00546949|Procedure|Interspinous Process Decompression (IPD)|Interspinous device
16313579|NCT00546936|Drug|ranibizumab|0.5mg ranibizumab
16313580|NCT00546936|Drug|verteporfin|Photodynamic therapy with verteporfin every 3 months for 1 year
16313581|NCT00546923|Drug|Venlafaxine XR|
16313582|NCT00546910|Drug|Atomoxetine|A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.
16313583|NCT00546910|Drug|Placebo|3 capsules of placebo have to be taken once daily in the morning, with or without food.
16313584|NCT00546897|Drug|Lenalidomide|
16313585|NCT00546884|Behavioral|MI condition|Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it.
16313586|NCT00546884|Behavioral|GI|The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
16313587|NCT00546871|Drug|Immune Globulin Intravenous (Human), 10%|Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3
16313588|NCT00546858|Other|Physical Examination|Patients will be invited to be evaluated in the Urology Research office at a future date.
16313589|NCT00546845|Device|Balloon angioplasty|Balloon angioplasty. Only stent if PTA fails
16313590|NCT00546845|Device|Use of self-expanding Expert stent|Nitinol stent
16313591|NCT00546832|Drug|TDS-943 (topical diclofenac sodium 4% spray)|
16313592|NCT00546832|Drug|celecoxib|
16313593|NCT00546832|Other|placebo|
16313594|NCT00546819|Biological|Zoster Vaccine, Live|A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
16313595|NCT00546819|Biological|Comparator: Placebo|A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
16313596|NCT00546806|Other|Programs of Care|Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
16313597|NCT00546793|Biological|veltuzumab|veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
16313598|NCT00546780|Drug|Tanespimycin|Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
16313599|NCT00546780|Drug|Bortezomib|Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
16313600|NCT00546767|Behavioral|Mail and Live Phone|This group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments.
16313601|NCT00546767|Behavioral|Interactive Voice Response (IVR)|In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants.
16313602|NCT00546767|Behavioral|Home-based Computer Kiosk|Participants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device.
16313603|NCT00546767|Behavioral|Traditional Evaluation Instruments|Evaluation methods typically used in clinical trials
16313604|NCT00546754|Drug|losartan potassium (+) hydrochlorothiazide|losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
16313605|NCT00546754|Drug|Comparator: Valsartan (+) Hydrochlorothiazide|Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
16313606|NCT00546741|Drug|Dapagliflozin|Tablets, Oral, 20 mg, once daily single dose
16313607|NCT00546741|Drug|Metformin|Tablets, Oral, 1000 mg, once daily, single dose
16313608|NCT00546741|Drug|Dapagliflozin + Metformin|"Tablets, Oral, once daily, single dose
~Dapagliflozin: 20 mg
~Metformin: 1000 mg"
16313609|NCT00546728|Drug|Exenatide|exenatide 10 mcg twice daily
16313610|NCT00546728|Drug|Metformin|metformin 500 twice daily
16313611|NCT00546715|Drug|Daclatasvir|Oral Solution, Oral, Single Dose
16313612|NCT00546715|Drug|Placebo|Oral Solution, Oral, Single Dose
16313613|NCT00546702|Drug|Insuline Glulisine|
16313614|NCT00546676|Drug|Telithromycin|
16313878|NCT00544817|Radiation|Radiation Therapy|2 Gy/fraction, single daily fractions M-F, to 60 Gy total
16313615|NCT00546663|Drug|inhaled 7% hypertonic saline (HS)|"7% hypertonic saline administered twice daily for 14 days by nebulization.
~A Pari Sprint Junior nebulizer equipped with a Pari Baby face mask and a Pari Proneb compressor will be used to administer the HS (PARI Respiratory Equipment, Inc., Midlothian, VA).
~To minimize the risk of cough and bronchospasm with HS inhalation, infants will be pre-treated prior to each dose of HS with albuterol by metered dose inhaler"
16313616|NCT00546650|Drug|Sumatriptan succinate|NP101 iontophoretic transdermal system
16313617|NCT00546650|Drug|Sumatriptan succinate|oral, subcutaneous, and intranasal formulations
16313618|NCT00546637|Drug|Fesoterodine|Fesoterodine 4mg or 8mg
16313619|NCT00546637|Drug|Placebo|Placebo
16313620|NCT00546624|Drug|MK0777|
16313621|NCT00546611|Drug|PEP005|
16313622|NCT00546598|Device|Total hip replacement/arthroplasty|Hip replacement
16313623|NCT00546585|Biological|Influenza A/H7N7 Vaccine|Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.
16313624|NCT00546585|Drug|Placebo|Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.
16313625|NCT00546572|Biological|13 valent Pneumococcal Conjugate Vaccine|0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
16313626|NCT00546572|Biological|23vPS|0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
16313627|NCT00546559|Drug|statins (simvastatin, pravastatin)|
16313628|NCT00546546|Drug|early immunosuppressants (azathioprine, methotrexate)|azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
16313629|NCT00546533|Drug|Etanercept|
16313630|NCT00546520|Drug|Ciclesonide|
16313631|NCT00546507|Drug|TDS-943 (topical diclofenac sodium 4% spray)|
16313632|NCT00546507|Drug|celecoxib|
16313633|NCT00546507|Other|placebo|
16313634|NCT00546494|Drug|Effexor® (Venlafaxine)|
16313635|NCT00546481|Drug|methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]|0.6 micrograms/kg every 2 weeks
16313636|NCT00546481|Drug|Epoetin|As prescribed, iv, 3 times weekly
16313637|NCT00546468|Procedure|laparoscopy assisted distal gastrectomy|under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.
16313638|NCT00546468|Procedure|Open distal gastrectomy|Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
16313639|NCT00546455|Drug|Fenretinide|200 mg/day
16313640|NCT00546455|Drug|Placebo|2 capsules/day
16313641|NCT00546442|Drug|Metformine|850-2550 mg/daily for 48 weeks
16313642|NCT00546442|Other|Placebo of metformine|850-2550 mg/daily for 48 weeks
16313643|NCT00546429|Device|Intramedullary nailing|Trochanteric nailing for proximal femoral fractures.
16313644|NCT00546403|Drug|Modafinil|Adjunctive treatment with titrated dose of modafinil
16313645|NCT00546403|Drug|Placebo|Adjunctive treatment with placebo
16313646|NCT00546390|Device|Blood Pressure Cuff|The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
16313647|NCT00546377|Biological|filgrastim|
16313648|NCT00546377|Biological|pegfilgrastim|
16313649|NCT00546377|Biological|rituximab|
16313650|NCT00546377|Biological|sargramostim|
16313651|NCT00546377|Drug|cyclophosphamide|
16313652|NCT00546377|Drug|mitoxantrone hydrochloride|
16313653|NCT00546377|Drug|pentostatin|
16313654|NCT00546377|Genetic|fluorescence in situ hybridization|
16313655|NCT00546377|Genetic|gene rearrangement analysis|
16313656|NCT00546377|Genetic|polymerase chain reaction|
16313657|NCT00546377|Genetic|protein expression analysis|
16313658|NCT00546377|Other|flow cytometry|
16313659|NCT00546377|Procedure|biopsy|
16313660|NCT00546364|Drug|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
16313661|NCT00546364|Drug|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
16313662|NCT00546364|Drug|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
16313663|NCT00546351|Drug|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
16313664|NCT00546325|Drug|Rimonabant|White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
16313665|NCT00546325|Drug|Placebo|Matching placebo tablets. Once daily before breakfast
16313666|NCT00546312|Device|Thoracic EXCLUDER Endoprosthesis|Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.
16313667|NCT00546299|Drug|oxygen|cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion
16313668|NCT00546286|Drug|dorzolamide hydrochloride (+) timolol maleate|"Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
~For patients who achieve target IOP at 6 weeks, dorzolamide/timolol is continued for another 6 weeks."
16313944|NCT00544466|Drug|melphalan|140 mg/m2 day -2 prior to transplant
16313669|NCT00546286|Drug|Comparator: dorzolamide HCl/timolol maleate + prostaglandin|"Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
~For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks."
16313670|NCT00546273|Biological|RUTI|dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
16313671|NCT00546273|Biological|RUTI|dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
16313672|NCT00546273|Biological|RUTI|dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
16313673|NCT00546273|Biological|RUTI|dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
16313674|NCT00546273|Biological|placebo of the vaccine RUTI|placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
16313675|NCT00546260|Drug|placebo|administration of iv bolus prior to angiography
16313676|NCT00546260|Drug|PRT060128 Potassium|administration of iv bolus prior to angiography
16313677|NCT00546247|Drug|Epofolate|Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses
16313678|NCT00546234|Drug|tiotropium|18 mcg daily via Handihaler
16313679|NCT00546234|Drug|long acting beta agonist|Turbohaler, 6 & 12 mcg
16313680|NCT00546221|Behavioral|Psychosocial support exercise programme|The experimental arm will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will comprise: fifteen minutes of psychosocial and motivational support, run by a qualified rehabilitation psychologist and overseen by a qualified health psychologist; a half hour preferred intensity exercise session run by a qualified sports physiotherapist. Participants preferred intensity (chosen exertion level) will be established using the Borg RPE scale (Borg G 1998).
16313681|NCT00546221|Behavioral|Prescribed exercise|This group will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will be an half hour exercise session, at a typically (GP) prescribed level, designed in accordance with national guidelines and run by a qualified sports physiotherapist.
16313682|NCT00546169|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|haemorrhages in cholecystectomy
16313683|NCT00546156|Drug|Doxorubicin|Standard chemotherapy regimen
16313684|NCT00546156|Drug|Cyclophosphamide|Standard chemotherapy regimen
16313685|NCT00546156|Drug|Paclitaxel|Standard chemotherapy regimen
16313686|NCT00546156|Drug|Bevacizumab|One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles.
16313687|NCT00546143|Drug|Omalizumab|
16313688|NCT00546143|Drug|Omalizumab|
16313689|NCT00546143|Drug|Omalizumab|
16313690|NCT00546130|Drug|Irinotecan hydrochloride|"Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16313691|NCT00546130|Drug|Cisplatin|Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16313692|NCT00546130|Drug|Krestin|Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
16313693|NCT00546117|Drug|lansoprazole|Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.
16313694|NCT00546117|Drug|placebo|Placebo Solutab in 15 and 30 mg dosages.
16313695|NCT00546104|Drug|Dasatinib|An initial dose of 50 mg PO BID; following 4 weeks of treatment, dose adjustment will be based on inhibition of phosphorylation of FAK and paxillin per biopsy assessment, as well as toxicity assessment.
16313696|NCT00546078|Biological|Cervarix™|Intramuscular injection, one or three doses
16313697|NCT00546065|Drug|esomeprazole treatment|concomitant esomeprazole treatment
16313698|NCT00546052|Drug|losartan potassium (+) hydrochlorothiazide|All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.
16313699|NCT00546039|Drug|Genistein|Capsule, 30 mg, oral daily for 3 to 6 weeks
16313700|NCT00546039|Drug|Placebo|Capsule
16313701|NCT00546026|Other|placental function assessment|Formal assessment of placental function in mid-gestation by placental morphology and uterine artery Doppler at 20-22 weeks and re-interpretation of prior biochemical tests for Down's syndrome and spina bifida.
16313702|NCT00546000|Drug|Fluticasone propionate 0.05% lotion|Daily applications
16313703|NCT00545987|Device|TriGrid™ Delivery System|Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
16313704|NCT00545987|Device|conventional intramuscular injection|administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
16313705|NCT00545974|Drug|memantine|memantine 10mg BID
16313706|NCT00545974|Drug|Placebo pill|Placebo pill BID
16313707|NCT00545961|Drug|placebo|mixture, 0.28125 ml/kg twice a day for 7 days
16313708|NCT00545961|Drug|amoxicillin clavulanate acid|mixture 0.28125 ml / kg twice a day for 7 days
16313709|NCT00545948|Drug|Vinorelbine followed by Cisplatin|Vinorelbine 25 mg/m2 IV over 6-10 minutes on days 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes on day 1 (every 21 days x 4 cycles).
16313710|NCT00545948|Drug|Pemetrexed followed by Cisplatin|Pemetrexed 500 mg/m2 IV infusion over approximately 10 minutes on day 1, followed by Cisplatin 75 mg/m2 IV over 60 min on day 1 (every 21 days x 4 cycles)
16313711|NCT00545935|Drug|Methylenblue-Amodiaquine (MB-AQ)|For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
16313712|NCT00545935|Drug|Methylenblue-Artesunate (MB-AS)|3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
16313713|NCT00545935|Drug|Artesunate-Amodiaquine (AS-AQ)|For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
16313714|NCT00545922|Behavioral|Cognitive behavioral therapy|Seven weekly sessions (2 hrs) in groups
16314029|NCT00544076|Procedure|robotic-assisted laparoscopic surgery|Undergo prostatectomy
16313715|NCT00545922|Behavioral|Minimal Telephone Contact|Telephone contact (max. 10 minutes) every other week during the 7-week intervention
16313716|NCT00545909|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months (+ feedback)
16313717|NCT00545909|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months (- feedback)
16313718|NCT00545896|Procedure|Extracorporeal shockwave therapy|Extracorporeal application of shockwaves on the surface of chronic wounds.
16313719|NCT00545870|Drug|bevacizumab|intravitreal application
16313720|NCT00545870|Drug|Ranibizumab|intravitreal application
16313721|NCT00545857|Drug|pioglitazone|Pioglitazone daily; dose varies with size
16313722|NCT00545857|Drug|Placebo control|Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
16313723|NCT00545844|Drug|montelukast sodium|montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
16313724|NCT00545831|Device|Taurolidine|2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
16313725|NCT00545831|Device|Physiologic Serum|2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
16313726|NCT00545818|Device|OsseoSpeed™ length 6 mm|OsseoSpeed™ dental implant, length: 6 mm
16313727|NCT00545818|Device|OsseoSpeed™ length 11 mm|OsseoSpeed™ dental implant, length: 11 mm
16313728|NCT00545805|Procedure|Roux-en-Y Gastric Bypass plus total omentectomy|Roux-en-Y Gastric Bypass plus total omentectomy
16313729|NCT00545805|Procedure|Roux-en-Y Gastric Bypass|Roux-en-Y Gastric Bypass without omentectomy
16313730|NCT00545792|Drug|Avastin|Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
16313731|NCT00545779|Drug|Ibandronate|150 mg orally once monthly for 6 months
16313732|NCT00545766|Drug|Vinflunine|Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
16313733|NCT00545753|Drug|Spinosad|10 minute topical application product, following by a complete rinse off.
16313734|NCT00545753|Drug|Spinosad|10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
16313735|NCT00545753|Drug|Permethrin 1%|Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
16313736|NCT00545740|Drug|SPD476 (1.2g)|1.2g SPD476 once daily (QD) orally
16313737|NCT00545740|Drug|SPD476 (2.4 g)|2.4g SPD476 QD orally
16313738|NCT00545740|Drug|SPD476 (4.8 g)|4.8g SPD476 QD orally
16313739|NCT00545740|Drug|Placebo|QD orally
16313740|NCT00545727|Behavioral|Diet|Whole-foods, low glycemic index diet
16313741|NCT00545727|Other|Standard diet|Standard diet meeting American Diabetes Association guidelines
16313742|NCT00545714|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
16313743|NCT00545714|Drug|Fludarabine|Fludarabine 25 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
16313744|NCT00545714|Drug|Rituximab|Rituximab 375 mg/m^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
16313745|NCT00545701|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5 mL, Intramuscular
16313746|NCT00545688|Drug|Herceptin|8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
16313747|NCT00545688|Drug|Docetaxel|75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
16313748|NCT00545688|Drug|Pertuzumab|840mg iv loading dose, followed by 420mg iv 3-weekly
16313749|NCT00545675|Drug|Abilify(aripiprazole)|Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
16313750|NCT00545675|Drug|Depakote (divalproate)|Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
16313751|NCT00545662|Drug|Placebo|Drug Placebo Inactive twice a day given orally or enterally. The first dose is given within 24 hours of injury and treatment continues until 90 days or until the 90-day outcome assessment.
16313752|NCT00545662|Drug|citicoline|1000 mg twice a day orally or enterally. The first dose is within 24 hours of injury and treatment continues for 90-days or until the 90-day outcome assessment.
16313753|NCT00545649|Behavioral|Exercise and education|
16313754|NCT00545649|Behavioral|Education|
16313755|NCT00545636|Other|education|The intervention is an education of the medical teams that instruct children to fast before the administration of general anesthesia
16313756|NCT00545623|Procedure|Acupuncture|acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
16313757|NCT00545623|Behavioral|Relaxation Response|listening to CDs with verbal instructions of techniques to elicit relaxation response
16313758|NCT00545623|Other|sham acupuncture|sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
16313759|NCT00545597|Drug|Lorenzo's oil|4:1 glyceryl trioleate-glyceryl trierucate (Lorenzo's oil)given orally, daily as approximately 10% of nutritional calories with supplementation.
16313760|NCT00545584|Drug|sitagliptin phosphate|sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
16313761|NCT00545584|Behavioral|Comparator: Diet|Diet
16313762|NCT00545584|Behavioral|Comparator: Physical Activity|Physical Activity
16313763|NCT00545571|Drug|Methoxy polyethylene glycol-epoetin beta|Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
16313764|NCT00545558|Drug|Efavirenz|600 mg tablet taken orally daily
16313765|NCT00545558|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally daily
16313766|NCT00545545|Biological|Safety and efficacy of escalating doses|Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
16313767|NCT00545545|Biological|Safety and efficacy of escalating doses.|Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
16313768|NCT00545532|Drug|oseltamivir|Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
16313769|NCT00545532|Other|placebo|Placebo matched to oseltamivir po twice daily for 10 days
16313770|NCT00545519|Drug|thymoglobulin|
16313771|NCT00545506|Device|conventional bandage|
16313772|NCT00545506|Device|warming bandage|
16313773|NCT00545493|Drug|Tacrolimus|tacrolimus capsules, dosing according to blood trough levels: 12-15 ng/ml during months 1-6, 5-10 ng/ml during months 7-12 and 5-8 ng/ml thereafter
16313774|NCT00545493|Drug|i.v. immunoglobulins|infusions, dosing: initially on three consecutive days 0,4 g/kg KG, thereafter 0,4 g/kg KG every month, after 12 months of treatment every two months).
16313775|NCT00545480|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 12 months (with feedback)
16313776|NCT00545480|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 12 months (without feedback)
16313777|NCT00545467|Drug|Aripiprazole|Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
16313778|NCT00545454|Drug|SSR150106|
16313779|NCT00545454|Drug|Placebos|
16313780|NCT00545441|Device|Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)|Surgical placement of the Surgisis AFP is performed under general anesthesia.
16313781|NCT00545441|Device|Flap|Advancement flap surgery is performed; no anal fistula plug is placed
16313782|NCT00545428|Procedure|Rhinoplasty|Mastoid bone autograft for dorsal nasal augmentation
16313783|NCT00545415|Dietary Supplement|Order 1|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313784|NCT00545415|Dietary Supplement|Order 2|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313785|NCT00545415|Dietary Supplement|Order 3|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313786|NCT00545415|Dietary Supplement|Order 4|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313787|NCT00545415|Dietary Supplement|Order 5|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313788|NCT00545415|Dietary Supplement|Order 6|"Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
~Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out."
16313789|NCT00545402|Drug|Mycophenolate mofetil, adjusted dose|3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.
16313790|NCT00545402|Drug|Tacrolimus|Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
16313791|NCT00545402|Drug|Corticosteroids, IV|10-15 mg/kg IV pre-operation on Day 0
16313792|NCT00545402|Drug|Mycophenolate mofetil, Standard dose|2 g/d PO BID during meals from Day 0 to Month 12
16313793|NCT00545402|Drug|Corticosteroids, PO|20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
16313794|NCT00545389|Drug|SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|
16313795|NCT00545376|Procedure|Osteopathic Manipulative Treatment - in clinic|I will do a thoracic/rib screening and treatment with muscle energy or facilitated positional release, a diaphragm soft tissue release, suboccipital release, and a thoracic compression. This treatment takes 10 minutes and is only done at the first visit.
16313796|NCT00545376|Procedure|Osteopathic Manipulative Treatment - at home|One group will learn how to do three home OMT techniques: suboccipital release, pectoral traction, and rib raising. They will be asked to do this at least 4 times a week for two weeks.
16313797|NCT00545376|Other|Education to physicians|I will educate physicians using demonstration and reading material as to the possible benefits of incorporating it into the treatment of asthma.
16313798|NCT00545363|Drug|Ibandronate|Participants will receive ibandronate 150 mg QM orally for 6 months.
16313799|NCT00545350|Other|Fall prevention exercise program|"Weekly physical exercise sessions in small groups, led by a qualified and specially trained instructor, and supplemented by simple exercises to do at home.
~The exercise program will focus on progressive balance retraining but will also include strength/resistance, coordination and flexibility training exercises."
16313800|NCT00545337|Drug|Insuline glulisine|
16313801|NCT00545324|Drug|MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks|
16313802|NCT00545324|Drug|Comparator: Fluticasone / Duration of Treatment: 6 Weeks|
16313803|NCT00545311|Drug|NVA237|
16313804|NCT00545311|Drug|NVA237|
16313805|NCT00545311|Drug|NVA237|
16313806|NCT00545311|Drug|NVA237|
16313808|NCT00545298|Drug|Nitric Oxide - same dose 6 wks|200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
16313809|NCT00545298|Drug|Nitric Oxide modified treatment|200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
16313810|NCT00545285|Procedure|Total Hip Arthroplasty|Surgical implantation of specific hip replacement components for treatment of osteoarthritis
16313811|NCT00545272|Drug|indacaterol|Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
16313812|NCT00545272|Drug|formoterol|Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
16313813|NCT00545272|Drug|placebo to indacaterol|Placebo TWISTHALER® device
16313814|NCT00545272|Drug|placebo to formoterol|Placebo AEROLIZER® device
16313815|NCT00545272|Drug|short acting β2-agonist|100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
16313816|NCT00545259|Drug|AEB071|
16313817|NCT00545246|Drug|aflibercept (AVE0005)|intravenous infusion
16313818|NCT00545246|Drug|docetaxel|intravenous infusion
16313819|NCT00545233|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms subcutaneous weekly for 48 weeks
16313820|NCT00545233|Drug|ribavirin [Copegus]|1000-1600 mg day orally for 48 weeks.
16313821|NCT00545233|Drug|Pioglitazone|30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
16313822|NCT00545220|Behavioral|problem-solving training|
16313823|NCT00545220|Behavioral|sham intervention|
16313824|NCT00545207|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 2 years
16313825|NCT00545207|Drug|Placebo|po monthly for 2 years
16313826|NCT00545194|Drug|Prostaglandin E2|
16313827|NCT00545181|Drug|Vaginal acidifying gel (RepHresh)|"placement of vaginal acidifying gel into vagina to restore normal vaginal pH."
16313828|NCT00545181|Drug|Metronidazole control|oral metronidazole therapy alone
16313829|NCT00545168|Drug|Spinosad|10 minute topical application of product, followed by a complete rinse off.
16313830|NCT00545168|Drug|Spinosad|10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
16313831|NCT00545168|Drug|Permethrin 1%|Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
16313832|NCT00545142|Drug|Abilify(Aripiprazole)|co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
16313833|NCT00545142|Drug|Depakote(Divalproate)|co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
16313834|NCT00545129|Drug|Tanezumab 10 mg IV|Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
16313835|NCT00545129|Drug|IV Placebo for tanezumab|Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
16313836|NCT00545116|Other|Hesperidin|250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
16313837|NCT00545103|Drug|SPD476, MMX™ mesalazine, 1.2g extended release tablet|SPD476 1.2g administered Once Daily (QD)
16313838|NCT00545103|Drug|SPD476, MMX™ mesalazine, 2.4g extended release tablet|SPD476 2.4g administered Once Daily (QD)
16313839|NCT00545103|Drug|SPD476, MMX™ mesalazine, 4.8g extended release tablet|SPD476 4.8g administered Once Daily (QD)
16313840|NCT00545103|Drug|Placebo|Placebo administered Once Daily (QD)
16313841|NCT00545090|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months
16313842|NCT00545077|Drug|Letrozole|
16313843|NCT00545077|Drug|Bevacizumab|
16313844|NCT00545077|Drug|Fulvestrant|
16313845|NCT00545064|Drug|dorzolamide hydrochloride (+) timolol maleate|dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment
16313846|NCT00545051|Drug|Placebo|po monthly for 12 months
16313847|NCT00545051|Drug|ibandronate|150mg po monthly for 12 months
16313848|NCT00545025|Biological|Influenza Vaccine GSK1247446A|Single dose, Intramuscular injection
16313849|NCT00545025|Biological|Fluarix™|Single dose, Intramuscular injection
16313850|NCT00545012|Drug|Levetiracetam|
16313851|NCT00544999|Drug|cytarabine|
16313852|NCT00544999|Drug|daunorubicin hydrochloride|
16313853|NCT00544999|Drug|everolimus|
16313854|NCT00544999|Other|laboratory biomarker analysis|
16313855|NCT00544999|Other|pharmacological study|
16313856|NCT00544986|Drug|Anastrozole|
16313857|NCT00544960|Drug|AT-101 and docetaxel|AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
16313858|NCT00544960|Drug|placebo and docetaxel|placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
16313859|NCT00544934|Drug|GLY-230|125, 250 0r 375 mg bid for 14 days
16313860|NCT00544934|Other|Placebo|No drug administered
16313861|NCT00544921|Drug|GLY-230|
16313862|NCT00544921|Other|Placebo|No drug administered
16313863|NCT00544908|Drug|dasatinib|
16313864|NCT00544908|Other|immunoenzyme technique|
16313865|NCT00544908|Other|immunohistochemistry staining method|
16313866|NCT00544908|Other|laboratory biomarker analysis|
16313867|NCT00544908|Procedure|quality-of-life assessment|
16313868|NCT00544882|Drug|DR-1021|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
16313869|NCT00544882|Drug|Mircette®|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
16313870|NCT00544882|Drug|Kariva®|Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
16313871|NCT00544869|Drug|OPC-41061 （Tolvaptan)|15-30mg/day,daily for 14days
16313872|NCT00544856|Behavioral|complex cognitive training|
16313873|NCT00544830|Drug|Bicalutamide|Given PO
16313874|NCT00544830|Drug|Goserelin Acetate|Given SC
16313875|NCT00544830|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16313876|NCT00544830|Other|Laboratory Biomarker Analysis|Correlative studies
16313879|NCT00544817|Drug|Temozolomide|"In Combined Modality Therapy, administered as 75 mg/m2 by mouth once daily
~In follow-up systemic therapy, administered as 150 mg/m2 by mouth on days 1-5 every 28 days for 6 cycles"
16313880|NCT00544817|Drug|Sorafenib|In follow-up systemic therapy, administered as 400 mg by mouth twice daily for 6 months
16313881|NCT00544804|Drug|lapatinib ditosylate|
16313882|NCT00544804|Genetic|gene expression analysis|
16313883|NCT00544804|Other|diagnostic laboratory biomarker analysis|
16313884|NCT00544791|Drug|melatonin|5 mg, oral, daily dose for 6 months
16313885|NCT00544791|Drug|placebo like melatonin tablets|
16313886|NCT00544778|Biological|filgrastim|
16313887|NCT00544778|Drug|dexrazoxane hydrochloride|
16313888|NCT00544778|Drug|doxorubicin hydrochloride|
16313889|NCT00544778|Drug|ifosfamide|
16313890|NCT00544778|Drug|irinotecan hydrochloride|
16313891|NCT00544778|Genetic|protein expression analysis|
16313892|NCT00544778|Other|immunoenzyme technique|
16313893|NCT00544778|Procedure|adjuvant therapy|
16313894|NCT00544778|Procedure|conventional surgery|
16313895|NCT00544778|Procedure|neoadjuvant therapy|
16313896|NCT00544778|Radiation|radiation therapy|
16313897|NCT00544765|Drug|TAC|Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks
16313898|NCT00544765|Drug|NX|Vinorelbine 25 mg/m² as a < 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks
16313899|NCT00544752|Other|16|indoor temperature of 16 degrees celcius
16313900|NCT00544752|Other|indoor temperature of 20 degrees celcius|indoor temperature of 20 degrees celcius
16313901|NCT00544752|Other|indoor temperature of 24 degrees celcius|indoor temperature of 24 degrees celcius
16313902|NCT00544726|Behavioral|Physical training|
16313903|NCT00544726|Behavioral|No training|
16313904|NCT00544713|Drug|Carboxymethylcellulose and Glycerin based artificial tear|As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
16313905|NCT00544713|Drug|Carboxymethylcellulose|As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
16313906|NCT00544700|Biological|bevacizumab|7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
16313907|NCT00544700|Other|no maintenance|No treatment until progression
16313908|NCT00544687|Drug|CRx-191|topical (mometasone furoate + nortriptyline HCl)
16313909|NCT00544687|Drug|mometasone furoate|topical mometasone furoate
16313910|NCT00544687|Drug|nortriptyline HCl|topical nortriptyline HCl
16313911|NCT00544687|Drug|Karison® Creme|topical Karison® Creme (clobetasol-17-propinate 0.05%)
16313912|NCT00544687|Drug|Vehicle|topical (placebo)
16313913|NCT00544674|Drug|PR104|administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks
16313914|NCT00544674|Other|F-18-fluoromisonidazole|administered intravenously prior to PET scan
16313915|NCT00544648|Drug|carboplatin|(AUC 2) through a vein over 30 minutes following nab-paclitaxel, once per week x 7 weeks
16313916|NCT00544648|Drug|nab-paclitaxel|Phase I: beginning at 40 mg/m2 through a vein over 30 minutes once per week x 7 weeks Phase II: Maximum tolerated dose through a vein over 30 minutes once per week x 7 weeks
16313917|NCT00544648|Radiation|Radiation therapy|3D conformal radiotherapy or Intensity-Modulated Radiation Therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy
16313918|NCT00544635|Device|no intervention|no intervention
16313919|NCT00544635|Device|light|scars will be treated with light
16313920|NCT00544622|Procedure|structured therapeutic chain of stroke treatment|
16313921|NCT00544609|Drug|Sorafenib|Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day
16313922|NCT00544609|Procedure|Radiotherapy|3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2
16313923|NCT00544596|Drug|R-(-)-gossypol acetic acid|Given orally
16313924|NCT00544596|Drug|cisplatin|Given IV
16313925|NCT00544596|Drug|etoposide|Given IV
16313926|NCT00544583|Procedure|Interrupted sutures|Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
16313927|NCT00544583|Procedure|Continuous sutures|Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
16313928|NCT00544570|Biological|filgrastim|
16313929|NCT00544570|Drug|carmustine|
16313930|NCT00544570|Drug|cyclophosphamide|
16313931|NCT00544570|Drug|etoposide|
16313932|NCT00544570|Drug|melphalan|
16313933|NCT00544570|Procedure|autologous hematopoietic stem cell transplantation|
16313934|NCT00544570|Procedure|peripheral blood stem cell transplantation|
16313935|NCT00544570|Radiation|radiation therapy|
16313936|NCT00544570|Radiation|total-body irradiation|
16313937|NCT00544557|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16313938|NCT00544544|Drug|Riluzole|50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks
16313939|NCT00544518|Drug|metformin|2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time
16313940|NCT00544518|Drug|benfluorex|2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time, one of 2 tablets is dummy tablet.
16313941|NCT00544505|Drug|Fluorouracil/Epirubicin/Cyclophosphamide|Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
16313942|NCT00544492|Device|catheter for AV fistula cannulation|catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
16313943|NCT00544466|Drug|fludarabine phosphate|25 mg/m2 day -7 through day -3 prior to transplant
16313945|NCT00544466|Procedure|allogeneic hematopoietic stem cell transplantation|Cells infused on Day 0 of transplant regimen
16313946|NCT00544466|Radiation|intensity-modulated radiation therapy|Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
16313947|NCT00544453|Drug|[123I] MNI-308|Injection of [123I] MNI-308 and SPECT scanning
16313948|NCT00544440|Drug|Abiraterone acetate|Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
16313949|NCT00544440|Drug|Prednisone|Prednisone 5 mg tablet taken orally twice daily
16313950|NCT00544427|Device|Optical coherence tomography|Optical coherence tomography imaging
16313951|NCT00544414|Drug|cisplatin|
16313952|NCT00544414|Drug|docetaxel|
16313953|NCT00544414|Drug|fluorouracil|
16313954|NCT00544414|Drug|gemcitabine hydrochloride|
16313955|NCT00544414|Drug|leucovorin calcium|
16313956|NCT00544414|Genetic|gene expression analysis|
16313957|NCT00544414|Genetic|protein expression analysis|
16313958|NCT00544414|Other|laboratory biomarker analysis|
16313959|NCT00544414|Procedure|adjuvant therapy|
16313960|NCT00544414|Procedure|biopsy|
16313961|NCT00544414|Procedure|conventional surgery|
16313962|NCT00544414|Procedure|neoadjuvant therapy|
16313963|NCT00544414|Procedure|quality-of-life assessment|
16313964|NCT00544414|Radiation|radiation therapy|
16313965|NCT00544401|Other|Hypnopuncture (Hypnosis+Acupuncture)|hypnosis and acupuncture
16313966|NCT00544388|Drug|levocetirizine dihydrochloride|
16313967|NCT00544375|Device|Optical measurement|Optical measurement neonatal tissues
16313968|NCT00544362|Biological|cetuximab|
16313969|NCT00544362|Drug|cisplatin|
16313970|NCT00544362|Drug|fluorouracil|
16313971|NCT00544362|Procedure|conventional surgery|
16313972|NCT00544349|Biological|cetuximab|
16313973|NCT00544349|Drug|fluorouracil|
16313974|NCT00544349|Drug|leucovorin calcium|
16313975|NCT00544349|Drug|oxaliplatin|
16313976|NCT00544336|Other|questionnaire administration|no intervention
16313977|NCT00544336|Other|survey administration|no intervention
16313978|NCT00544336|Procedure|quality-of-life assessment|no intervention
16313979|NCT00544323|Device|oral implant|
16313980|NCT00544310|Biological|Anti adhesion agent|Adhesions prevention
16313981|NCT00544297|Drug|PEP005 gel|Two day application, 0.05%
16313982|NCT00544284|Drug|bortezomib|
16313983|NCT00544284|Drug|temozolomide|
16313984|NCT00544284|Other|pharmacological study|
16313985|NCT00544271|Biological|INFANRIX|
16313986|NCT00544271|Biological|BOOSTRIX|
16313987|NCT00544271|Biological|HAVRIX|
16313988|NCT00544258|Drug|PEP005|
16313989|NCT00544245|Behavioral|Self monitoring of estimated energy balance|Participant estimation of energy intake and energy expenditure
16313990|NCT00544232|Drug|Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa|"Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×
~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel"
16313991|NCT00544232|Drug|Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa|"Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF
~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF"
16313992|NCT00544219|Biological|rituximab|375 mg/m2 i.v. per cycle
16313993|NCT00544219|Drug|cyclophosphamide|750 mg/m2 i.v. per cycle
16313994|NCT00544219|Drug|doxorubicin hydrochloride|50 mg/m2 i.v. per cycle
16313995|NCT00544219|Drug|prednisone|100 mg/day p.o. per cycle
16313996|NCT00544219|Drug|vincristine sulfate|1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
16313997|NCT00544219|Procedure|positron emission tomography|PET Scan during treatment
16313998|NCT00544206|Other|standard enteral feeding product|16 hrs daily x 5 days
16313999|NCT00544206|Other|Diabetes specific feeding product|16 hrs daily for 5 days
16314000|NCT00544193|Drug|gemcitabine hydrochloride|
16314001|NCT00544193|Genetic|polymerase chain reaction|
16314002|NCT00544193|Other|immunohistochemistry staining method|
16314003|NCT00544193|Procedure|conventional surgery|
16314004|NCT00544193|Radiation|intraoperative radiation therapy|
16314005|NCT00544193|Radiation|radiation therapy|
16314006|NCT00544180|Drug|Risedronate|
16314007|NCT00544167|Drug|Doxorubicin|
16314008|NCT00544167|Drug|Cyclophosphamide|
16314009|NCT00544167|Drug|Paclitaxel|
16314010|NCT00544167|Drug|Sorafenib|
16314011|NCT00544154|Drug|CDP870|
16314012|NCT00544128|Drug|lamivudine, abacavir , ritonavir, atazanavir|Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
16314013|NCT00544128|Drug|emtricitabine, tenofovir, ritonavir, atazanavir|Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
16314014|NCT00544115|Drug|busulfan|
16314015|NCT00544115|Drug|cyclophosphamide|
16314016|NCT00544115|Drug|cyclosporine|
16314017|NCT00544115|Drug|etoposide|
16314018|NCT00544115|Drug|fludarabine phosphate|
16314019|NCT00544115|Drug|melphalan|
16314020|NCT00544115|Drug|methotrexate|
16314021|NCT00544115|Drug|mycophenolate mofetil|
16314022|NCT00544115|Drug|sirolimus|
16314023|NCT00544115|Drug|tacrolimus|
16314024|NCT00544115|Procedure|allogeneic hematopoietic stem cell transplantation|
16314025|NCT00544115|Procedure|peripheral blood stem cell transplantation|
16314026|NCT00544115|Radiation|total-body irradiation|
16314027|NCT00544076|Drug|sildenafil citrate|Given orally
16314028|NCT00544076|Drug|alprostadil|Given intraurethrally
16314030|NCT00544076|Procedure|quality-of-life assessment|Ancillary studies
16314031|NCT00544076|Other|questionnaire administration|Ancillary studies
16314032|NCT00544063|Drug|irinotecan hydrochloride|
16314033|NCT00544063|Drug|oxaliplatin|
16314034|NCT00544050|Drug|Levetiracetam|
16314035|NCT00544037|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Standard Therapy for Multiple Sclerosis
16314036|NCT00544011|Biological|bevacizumab|
16314037|NCT00544011|Drug|capecitabine|
16314038|NCT00544011|Drug|fluorouracil|
16314039|NCT00544011|Drug|irinotecan hydrochloride|
16314040|NCT00544011|Other|diagnostic laboratory biomarker analysis|
16314041|NCT00543998|Device|Optical Measurement transillumination|Optical Measurement of sinus
16314042|NCT00543985|Procedure|Stress Echocardiography|Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
16314043|NCT00543972|Drug|AVE9633|Intravenous Infusion
16314044|NCT00543959|Drug|MK0533|Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.
16314045|NCT00543959|Drug|Comparator: Placebo (unspecified)|MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
16314046|NCT00543959|Drug|Comparator: pioglitazone|pioglitazone 45mg. Study period is a total of 24 wks.
16314047|NCT00543946|Drug|GAP-134|24-Hour IV infusion, SAD
16314048|NCT00543933|Drug|iNO administered|iNO at 40 ppm through a non-rebreather mask for 5 minutes
16314049|NCT00543920|Drug|MK0777|
16314050|NCT00543881|Device|Remote patient monitoring (Partnership for the Heart)|Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness
16314051|NCT00543881|Device|Usual care group|Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits
16314052|NCT00543868|Drug|MK0782|
16314053|NCT00543855|Drug|3 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
16314054|NCT00543855|Drug|5 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
16314055|NCT00543855|Drug|10 mg Donepezil hydrochloride|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
16314056|NCT00543855|Drug|Placebo|"Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
16314057|NCT00543842|Drug|Bevacizumab|5 mg/kg By Vein Every 2 Weeks x 3 Doses (Weeks 1, 3, 5)
16314058|NCT00543842|Drug|Capecitabine|Starting Dose 650 mg/m^2 By Mouth Twice Daily Monday-Friday x 6 Weeks
16314059|NCT00543842|Drug|Erlotinib|Starting Dose 50 mg By Mouth Daily Weeks 1-3
16314060|NCT00543842|Radiation|Radiation Therapy|30 minute radiation treatments, dose of 50.4 Gy once daily on 5 consecutive days, for up to 5 weeks and 3 days, totaling 28 treatments
16314061|NCT00543842|Procedure|Surgery|At least 8 weeks after radiation therapy, surgical removal of rectal tumor
16314062|NCT00543829|Drug|doxorubicin, docetaxel, tamoxifen|Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery)
16314063|NCT00543829|Drug|doxorubicin, docetaxel|Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
16314064|NCT00543816|Drug|MK0767|
16314065|NCT00543790|Drug|PRA-027|PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
16314066|NCT00543777|Diagnostic Test|Magnetic Resonance Elastogram|Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.
16314067|NCT00543777|Diagnostic Test|2-Point Dixon Magnetic Resonance Imaging|Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
16314068|NCT00543764|Other|pathway|Comparison of pre and post pathway
16314069|NCT00543751|Drug|MK0767|
16314070|NCT00543738|Drug|MK0767|
16314071|NCT00543725|Drug|TMC278|25 mg tablet once daily for 96 weeks
16314072|NCT00543725|Drug|efavirenz|600 mg tablet once daily for 96 weeks
16314073|NCT00543712|Drug|PRO95780|Intravenous repeating dose
16314074|NCT00543686|Drug|Montelukast|Intake of Montelukast
16314075|NCT00543686|Drug|Fluticasone|Intake of Fluticasone
16314076|NCT00543673|Other|Milk based formula A|feed as per HCP directions
16314077|NCT00543673|Other|#2 Standard formula|Feed as per HCP directions
16314078|NCT00543673|Other|#3 Human Milk|Feed as per HCP directions
16314079|NCT00543673|Other|Milk based formula C|Feed as per HCP direction
16314080|NCT00543660|Procedure|Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)|
16314081|NCT00543647|Drug|Fenofibrate 160 mg tablet|
16314082|NCT00543647|Drug|Placebo|
16314083|NCT00543634|Drug|Premarin/MPA|0.625 mg/2.5 mg X4
16314084|NCT00543634|Drug|Premarin/MPA|0.625 mg/5 mg X 2
16314085|NCT00543634|Drug|Provera 10 mg|2.5 mg of MPA, 4 tablets dissoved in water
16314086|NCT00543621|Other|daily enteral nutritional product and/or behavioral changes|
16314087|NCT00543608|Drug|iclaprim|
16314088|NCT00543608|Drug|vancomycin|
16314089|NCT00543595|Drug|MK0916|
16314090|NCT00543582|Drug|MGCD0103 and Azacitidine|"In Part 1 of the study, up to 22 people to enroll will receive a single, oral dose (75 mg gelcap) of MGCD0103 and FB-MGCD0103 during their first 2 weeks in the study. Up to 22 additional people will receive a single dose of both MGCD0103 and TA-FB-MGCE0103. The next group of people to enroll will receive 2 different single doses (25, 50, 100 mg) of FB-MGCD0103 or TA-FB-MGCD0103 during their first 2 weeks in the study.
~In Part 2 of the study, from Day 1-5 of each 28-day cycle, all subjects will receive a dose of azacitidine (75 mg/m2) either subcutaneously or through an intravenous device, and on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, a single, oral dose (85 mg) of MGCD0103 until progression or unacceptable toxicity develops."
16314091|NCT00543569|Drug|Alefacept|Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
16314092|NCT00543569|Drug|tacrolimus|The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
16314093|NCT00543569|Drug|basiliximab|Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
16314094|NCT00543569|Drug|mycophenolate mofetil|Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
16314095|NCT00543569|Drug|Corticosteroids|Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
16314096|NCT00543556|Drug|MK0767|
16314097|NCT00543543|Biological|Comparator: GARDASIL|GARDASIL (quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen
16314098|NCT00543543|Biological|Experimental: V503|V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen (and a fourth injection for Cohort 1 only).
16314099|NCT00543530|Drug|MK0831|
16314100|NCT00543517|Drug|MK0767|
16314101|NCT00543504|Drug|Bevacizumab|2.5 mg/kg By Vein Over 90 Minutes.
16314102|NCT00543504|Drug|Sorafenib|200 mg By Mouth Daily for 28 Days
16314103|NCT00543504|Drug|Erlotinib|50 mg By Mouth Daily for 28 Days.
16314104|NCT00543504|Drug|Trastuzumab|Loading 2 mg/kg by vein then Maintenance 1 mg/kg by vein on Day 1
16314105|NCT00543504|Drug|Lapatinib|250 mg By Mouth Daily for 21 Days.
16314106|NCT00543504|Drug|Sunitinib|12.5 mg orally daily for 4 weeks, then 2 weeks off.
16314107|NCT00543504|Drug|Cetuximab|Loading 100 mg/m² by vein and Maintenance 75 mg/m² by vein on Days 1, 8, 15, 22
16314108|NCT00543491|Drug|MK0767|
16314109|NCT00543478|Drug|Saccharomyces boulardii|250mg, twice a day in sachets, for 8 weeks
16314110|NCT00543478|Drug|Methyl cellulose powder (low viscosity)|twice a day sachets for 10 weeks
16314111|NCT00543465|Drug|MK0782|
16314112|NCT00543452|Other|Oxygen|4 liters of oxygen a minute
16314113|NCT00543452|Other|Air from a placebo oxygen delivery|4 liters a minute of air from a placebo device
16314114|NCT00543439|Biological|Moroctocog alfa (AF-CC)|On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
16314115|NCT00543439|Biological|Moroctocog alfa (AF-CC)|"Routine prophylaxis crossover:
~45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year."
16314116|NCT00543426|Drug|Fuzheng Huayu Tablets|Tablet,three times a day,four tablets one time
16314117|NCT00543426|Drug|sham Fuzheng Huayu Tablets (placebo)|Tablet, three times a day, four tablets one time
16314118|NCT00543413|Drug|MK8141|MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
16314119|NCT00543413|Drug|Comparator: placebo (unspecified)|MK8141 Pbo tablet once daily. 4 week treatment period.
16314120|NCT00543413|Drug|Enalapril|Enalapril 20 mg tablet once daily. 4 week treatment period.
16314121|NCT00543400|Drug|M118|intravenous (IV) infusion
16314122|NCT00543400|Drug|Unfractionated Heparin|IV infusion
16314123|NCT00543387|Drug|MK-5108|MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
16314124|NCT00543387|Drug|docetaxel|Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.
16314125|NCT00543374|Drug|Placebo|Placebo
16314126|NCT00543374|Drug|PROCHYMAL adult human mesenchymal stem cells|intravenous infusion four times over two weeks; possibly repeated once
16314127|NCT00543361|Drug|MK0767|Duration of Treatment: 52 Weeks
16314128|NCT00543361|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 52 Weeks
16314129|NCT00543361|Drug|Comparator: metformin|Duration of Treatment: 52 Weeks
16314130|NCT00543348|Procedure|CUTTING BALLOON ANGIOPLASTY|CUTTING BALLOON
16314131|NCT00543348|Procedure|HIGH PRESSURE BALLOON|
16314132|NCT00543335|Drug|Sorafenib|Starting dose 200 mg PO (by mouth) Daily
16314133|NCT00543335|Procedure|Radiation Therapy|45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks
16314134|NCT00543309|Drug|nesiritide|Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted
16314135|NCT00543309|Drug|milrinone|Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted
16314136|NCT00543309|Drug|placebo|Placebo bolus on CPB, then placebo infusion
16314137|NCT00543296|Drug|0.59 mg Fluocinolone Acetonide implant|0.59 mg Fluocinolone Acetonide implant
16314281|NCT00542139|Drug|Bupivocaine|Intraarticular injection of 10ml of Bupivocaine
16314138|NCT00543270|Device|Powerlink infrarenal bifurcated stent graft delivery system|Endovascular abdominal aortic aneurysm repair
16314139|NCT00543270|Procedure|Open Surgery|Open surgical abdominal aortic aneurysm repair
16314140|NCT00543257|Other|Use of paper forms to write down information|Parents will be asked to write down information specific to their child's ADHD using paper forms.
16314141|NCT00543257|Other|Computer|Parents will use a computer to complete data entry on information specific to their child's ADHD care
16314142|NCT00543244|Drug|Pegylated interferon alfa and ribavirin|"Pegylated interferon alfa-2a 180 ug/week or pegylated interferon alfa-2b 1.5 ug/kg/week Ribavrin 800-1200 mg/day (genotype 1: < 75 kg 1000 mg/day, >=75 kg 1200 mg/day; genotype 2: 800 mg/day)
~HCV genotype: baseline (Day 0) HCV RNA (real time PCR test): baseline (Day 0), Day 1 (4,8,12 hours after pegylated interferon + ribavirin), Day 2 (24,36 hours), Day 3(48 hours), Day 4 (72 hours), Day 5 (96 hours), Week 2,4,6,8,12,16,20,24, and 28,32,36,40,44,48,72 (for genotype 1 with 48 weeks of treatment), and 48 (for genotype 1 or 2 with 24 weeks of treatment)"
16314143|NCT00543231|Drug|G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide|
16314144|NCT00543218|Drug|teriparatide 20 micrograms/day subcutaneous|
16314145|NCT00543218|Drug|calcitonin 100 IU/day subcutaneous|
16314146|NCT00543205|Drug|Genasense® (G3139, oblimersen sodium)|Genasense 7 mg/kg/day for 5 days
16314147|NCT00543179|Drug|Somatuline (Lanreotide Autogel®)|
16314148|NCT00543166|Drug|dehydroepiandrosterone|50 mg of dehydroepiandrosterone in the morning for 4 months in the treatment group.
16314149|NCT00543153|Behavioral|Interview|Interview lasting approximately 30-45 minutes.
16314150|NCT00543140|Device|REALIZE™ Swedish Adjustable Gastric Band|Laparoscopic placement of the Swedish Adjustable Gastric Band
16314151|NCT00543127|Drug|Fulvestrant|500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
16314152|NCT00543127|Drug|Anastrozole|1 mg oral Anastrozole per day during 5 years.
16314153|NCT00543114|Drug|Lenalidomide|Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period
16314154|NCT00543114|Drug|Fludarabine|Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days
16314155|NCT00543114|Drug|Rituximab|Given intravenously on Day 1 of each 28 day cycle
16314156|NCT00543101|Drug|Darunavir (DRV/r)|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
16314157|NCT00543101|Drug|continue on current dual boosted PI|Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks
16314158|NCT00543075|Drug|Genasense (oblimersen, G3139)|3 mg/kg/day by intravenous infusion for up to 48 hours
16314159|NCT00543062|Drug|Inhaled placebo|Inhaled Staccato placebo (0 mg)
16314160|NCT00543062|Drug|Oral placebo|Oral placebo (identical to 400 mg moxifloxacin)
16314161|NCT00543062|Drug|Inhaled prochlorperazine 5 mg|Staccato prochlorperazine 5 mg, single dose
16314162|NCT00543062|Drug|Inhaled prochlorperazine 10 mg|Inhaled prochlorperazine 10 mg, single dose
16314163|NCT00543062|Drug|Oral moxifloxacin|Oral moxifloxacin 400 mg, si/ngle dose
16314164|NCT00543049|Drug|Sunitinib|Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year
16314165|NCT00543049|Drug|SUNITINIB|Sunitinib, oral, 37,5 mg once daily continuously, up to one year
16314166|NCT00543036|Device|H-Coil deep TMS|
16314167|NCT00543023|Drug|teriparatide 20 micrograms/day subcutaneous|
16314168|NCT00543023|Drug|salmon calcitonin 100 IU/day subcutaneous|
16314169|NCT00543010|Drug|MK0767|
16314170|NCT00542997|Biological|Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.
16314171|NCT00542984|Drug|teriparatide 20 micrograms/day subcutaneous|
16314172|NCT00542984|Drug|salmon calcitonin 100 IU/day subcutaneous|
16314173|NCT00542971|Drug|Idarubicin|12 mg/m^2 IV over 1 hour daily (days 1-3)
16314174|NCT00542971|Drug|Sorafenib|Starting dose 400 mg by mouth for 7 days
16314175|NCT00542971|Drug|Ara-C|1.5 g/m^2 IV over 24 hours daily (days 1-4)
16314176|NCT00542958|Drug|NK012|9.0, 12.0, 16.0, 21.0, 28.0 mg/m^2, and to be determined. Intravenous infusion
16314177|NCT00542945|Device|ICD|Implantation of an ICD
16314178|NCT00542945|Other|Optimal medical treatment|ACE-inhibitors or ARB Beta-blocker Optional aldosterone antagonist
16314179|NCT00542932|Other|Exercise|"Watched Film A (promotional film)
~Film B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home"
16314180|NCT00542919|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily until progressive disease
16314181|NCT00542906|Other|localization|localization of the several types of somatosensory stimuli
16314182|NCT00542893|Drug|Genasense® (G3139, oblimersen sodium)|
16314183|NCT00542893|Drug|Genasense followed by DTIC; then DTIC alone|Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
16314184|NCT00542893|Drug|DTIC alone; then Genasense followed by DTIC|Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
16314185|NCT00542880|Drug|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg|
16314186|NCT00542880|Drug|Seretide Diskus (salmeterol/fluticasone) 50/500 μg|
16314187|NCT00542854|Device|MP3|4 different brands of MP3 players will be tested at 3 distances from ICD/pacemaker site in children and adults with congenital heart disease.
16314188|NCT00542841|Procedure|Hydrocortisone withdrawal|This is considered a non-standard treatment. On Day 1, participants will receive one 10-mg pill of hydrocortisone. On Day 3, participants will receive intravenously a medicine called cosyntropin, a synthetic form of a hormone that the body makes. Participants will receive one last pill of hydrocortisone prior to the end of the study.
16314282|NCT00542126|Drug|Decapeptyl 0.1 mg after embryo transfer|Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer
16314189|NCT00542828|Biological|Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)|All patients were to be treated with rATG 3.75 mg/kg/day administered by intravenous (IV) infusion over ≥6 hours for 5 consecutive days (cumulative dose: 18.75 mg/kg)
16314190|NCT00542815|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
16314191|NCT00542815|Drug|Another Phosphate binder (Sevelamer)|Current approved dosing recommendations for 12 weeks
16314192|NCT00542802|Drug|Levetiracetam|Levetiracetam tablets 250-500 mg. The drug dosage will be up-titrated from 250 mg bid in the first 2 weeks to 500 mg bid during the rest of the treatment period. The dosage can be incremented until 1500 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
16314193|NCT00542802|Drug|Carbamazepine|Carbamazepina tablets 200 mg. The drug dosage will be up-titrated from 100 mg die in the first 3 days to 100 mg bid during days 4 to 7, to 200 mg bid in the 2nd week, to 300 mg bid during the rest of the treatment period. The dosage can be incremented until 800 mg bid, at Investigator judgement if crisis continue, or it can be reduced in case of adverse events
16314194|NCT00542789|Drug|Esomeprazole|20mg once daily oral
16314195|NCT00542789|Drug|Placebo|once daily oral
16314196|NCT00542776|Other|blood draw|drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)
16314197|NCT00542763|Drug|Mycophenolate sodium|Medical treatment is initiated with one tablet of 360 mg mycophenolate sodium orally per day for eligible patient. The dosage will be increased weekly by 360 mg up to a maximum stable dose of 1440mg daily. In patients not well tolerating the drug the dosage can be reduced to 720 mg per day.
16314198|NCT00542750|Drug|N-Acetylcysteine|N-Acetylcysteine 1200 mg twice daily for four weeks
16314199|NCT00542737|Behavioral|Web-Based Educational Program|Participating clinicians at each hospital will access the Web site as often as necessary for a 6-month period. The Web site will contain background and educational information on ALI/ARDS and LPV, including how to recognize ALI/ARDS and how to implement LPV in patients. Scholarly articles and other materials, including a chart to help clinicians determine appropriate ventilator settings for each patient, will be available to download. Clinicians will also be able to email questions to critical care experts.
16314200|NCT00542724|Drug|VIAject™|Dosage as individually required
16314201|NCT00542724|Drug|Regular Human Insulin|Dosage as individually required
16314202|NCT00542711|Drug|liquid tumeric/curcumin extract|30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.
16314203|NCT00542698|Behavioral|Effect of Physical Activity on Type II Diabetes Mellitus|Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.
16314204|NCT00542685|Drug|PD 0332334|Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
16314205|NCT00542685|Drug|Placebo|Capsules, oral, placebo BID, 8 weeks with 2 week taper.
16314206|NCT00542685|Drug|PD 0332334|Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
16314207|NCT00542685|Drug|PD 0332334|Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
16314208|NCT00542646|Procedure|Endovascular Intervention|Peritoneal Lined Stent Endovascular Intervention
16314209|NCT00542633|Drug|VIAject™|Dosage as individually required
16314210|NCT00542633|Drug|Regular Human Insulin|Dosage as individually required
16314211|NCT00542620|Drug|insulin detemir|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart
16314212|NCT00542620|Drug|insulin aspart|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir
16314213|NCT00542620|Drug|insulin detemir|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart
16314214|NCT00542620|Drug|insulin aspart|Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir
16314215|NCT00542607|Drug|levocetirizine dihydrochloride|
16314216|NCT00542581|Device|The Acrysof toric SN60T3 IOL|Intraocular Lens
16314217|NCT00542568|Biological|EPODURE (dermal Biopump for erythropoietin)|Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump
16314218|NCT00542555|Drug|Placebo|At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
16314219|NCT00542555|Drug|Naproxcinod 375 mg|
16314220|NCT00542555|Drug|Naproxen|
16314221|NCT00542555|Drug|Naproxcinod 750 mg|
16314222|NCT00542542|Procedure|Paravertebral Block|Paravertebral block given as a bolus injection into the paravertebral space.
16314223|NCT00542542|Drug|Propofol|2-2.5 mg/kg IV over 1-4 hours during surgery.
16314224|NCT00542542|Drug|Fentanyl|50-250 mcg IV over 1-4 hours during surgery.
16314225|NCT00542542|Drug|Ropivacaine|Ropivacaine given by injection into the paravertebral space along the spinal canal.
16314226|NCT00542542|Drug|Midazolam|0.08 mg/kg IV over 1-4 hours during the surgery.
16314227|NCT00542529|Biological|Imprime PGG TM for Injection|Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
16314228|NCT00542516|Drug|Hydroxyethyl Starch|Dosage: 30ml/kg; frequency: one time; duration: 60min
16314229|NCT00542516|Drug|Ringer's lactate|Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups
16314230|NCT00542490|Radiation|Vaginal Cuff Brachytherapy|Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
16314231|NCT00542464|Biological|Imprime PGG TM for Injection|Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
16314232|NCT00542451|Drug|Paclitaxel|Every week for 12 weeks
16314233|NCT00542451|Drug|Trastuzumab|Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
16314234|NCT00542438|Behavioral|Physical Activity Recall|Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.
16314235|NCT00542438|Behavioral|Environmental Assessments|Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).
16314236|NCT00542425|Drug|teriparatide|teriparatide 20 µg subcutaneous daily
16314237|NCT00542425|Drug|Placebo|Placebo subcutaneous daily
16314238|NCT00542425|Drug|BA058 20 µg|BA058 20 µg subcutaneous daily
16314239|NCT00542425|Drug|BA058 40 µg|BA058 40 µg subcutaneous daily
16314240|NCT00542425|Drug|BA058 80 µg|BA058 80 µg subcutaneous daily
16314241|NCT00542412|Drug|Riluzole|
16314242|NCT00542399|Drug|Levemir (insulin detemir)|Levemir once a day
16314243|NCT00542399|Drug|Levemir twice a day|Levemir twice a day
16314244|NCT00542386|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
16314245|NCT00542386|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
16314246|NCT00542373|Other|Cytology Specimen Collection Procedure|Undergo oral tissue collection
16314247|NCT00542373|Procedure|Diagnostic Microscopy|Mouth tissue examined microscopically for cytologic features
16314248|NCT00542373|Procedure|Diagnostic Procedure|Undergo standard white light headlamp oral examination
16314249|NCT00542373|Procedure|Fluorescence Imaging|Undergo widefield fluorescent and reflectance imaging
16314250|NCT00542373|Procedure|Fluorescence Spectroscopy|Undergo point fluorescent spectroscopy
16314251|NCT00542360|Behavioral|Marketing program to motivate exercise class participation|Using qualitative research methods, a targeted social marketing program, including a 'marketing toolkit,' was developed to motivate participation in exercise classes by older adult members of churches. The Health Belief and Transtheoretical Models formed the theoretical basis for the social marketing planning process and guided program design. The marketing program aimed to increase exercise class attractiveness, usability, and uptake by reducing barriers and costs, and using messaging about benefits and enhanced convenience to motivate participation. The intervention was implemented through churches.
16314252|NCT00542347|Drug|Esomeprazole first|"esomeprazole 20mg po once per day for 7 days
~24hr pH study on day 7
~followed by washout for 7 days
~generic omeprazole 20mg po once per day for 7 days
~24hr pH study on day 7"
16314253|NCT00542347|Drug|Generic omeprazole first|"generic omeprazole 20mg po once per day for 7 days
~24hr pH study on day 7
~followed by washout for 7 days
~esomeprazole 20mg po once per day for 7 days
~24hr pH study on day 7"
16314254|NCT00542321|Other|Manual turn|Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
16314255|NCT00542321|Device|kinetic therapy bed|Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
16314256|NCT00542308|Drug|Zalutumumab|Individual dose titration weekly i.v. doses
16314257|NCT00542295|Drug|alverine citrate and simeticone|
16314258|NCT00542295|Drug|placebo|
16314259|NCT00542269|Drug|Amlodipine|amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
16314260|NCT00542269|Drug|Aliskiren|aliskiren 150-300 mg tablets. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
16314261|NCT00542269|Drug|Ramipril|ramipril 5-10 mg capsules. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
16314262|NCT00542256|Device|Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy|14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.
16314263|NCT00542256|Device|Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy|14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
16314264|NCT00542243|Drug|Finasteride|Finasteride (5mg) will be given once per day for 6 months.
16314265|NCT00542243|Drug|Placebo|Placebo will be given once a day for 6 months.
16314266|NCT00542217|Biological|Imprime PGG|
16314267|NCT00542204|Behavioral|Online disease management|The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.
16314268|NCT00542191|Drug|Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin|DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks
16314269|NCT00542191|Procedure|Definitive Surgery|Standard of care definitive surgery as determined by medical provider
16314270|NCT00542191|Radiation|Radiotherapy|Standard of care RADIATION THERAPY as indicated
16314271|NCT00542178|Drug|Hypoglycemic Agents|Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
16314272|NCT00542178|Drug|Standard glycemia control|A strategy of glycemia drugs for HbA1c 7% - 7.9%
16314273|NCT00542178|Drug|Intensive BP treatment|A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
16314274|NCT00542178|Drug|Standard BP control|A strategy of BP drugs for SBP less than 140 mm Hg
16314275|NCT00542178|Drug|Fenofibrate|Blinded fenofibrate
16314276|NCT00542178|Drug|Simvastatin|Simvastatin 20-40 mg/d
16314277|NCT00542178|Drug|Placebo|Placebo
16314278|NCT00542165|Drug|Alfuzosin|
16314279|NCT00542152|Drug|CYCLOSPORINE VS INFLIXIMAB|"Cyclosporine 2mg/kg/day intravenous for 7 days then Neoral 4mg/kg/day orally for 3 months.
~Infliximab 5mg/kg at weeks 0, 2 and 6"
16314280|NCT00542139|Drug|Betamethasone|Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)
16314283|NCT00542113|Behavioral|DvtProgram ENERGY|11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
16314284|NCT00542113|Behavioral|DvtProgram ENERGY|6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
16314285|NCT00542113|Behavioral|DvtProgramENERGY|Children participating in Program ENERGY but no newsletters or family challenges sent home to parents
16314286|NCT00542100|Device|PCMRI|
16314287|NCT00542087|Drug|MK0663, etoricoxib / Duration of Treatment: 6 Weeks|
16314288|NCT00542087|Drug|Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks|
16314289|NCT00542074|Other|hygienic information plus 62% ethyl alcohol in emollient gel|The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®).
16314290|NCT00542074|Other|hygienic information|Couples received a brochure with information on control of STI and good hygienic practices.
16314291|NCT00542061|Device|half-yearly monitoring routine|A written expert advice for GPs on additional diagnostic, treatment, and referral of patients with asthma and COPD based on half-yearly monitoring routines (lung function assessments including extensive anamnese) supported by half-yearly visits of an AC nurse consultant to the general practices.
16314292|NCT00542048|Drug|EndoTAG®-1|EndoTAG®-1 22 mg/m² twice weekly
16314293|NCT00542035|Drug|ARRY-371797, p38 inhibitor; oral|dose 1, dose 2
16314294|NCT00542035|Drug|Placebo; oral|dose 1, dose 2
16314295|NCT00542035|Drug|Placebo; oral|dose 1
16314296|NCT00542035|Drug|ARRY-371797, p38 inhibitor; oral|dose 2
16314297|NCT00542022|Drug|MK0812 / Duration of Treatment: 12 Weeks|
16314298|NCT00542022|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks|
16314299|NCT00542009|Drug|CE-326,597 100 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
16314300|NCT00542009|Drug|CE-326,597 50 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
16314301|NCT00542009|Drug|CE-326,597 25 mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
16314302|NCT00542009|Drug|Placebo|Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
16314303|NCT00542009|Drug|CE-326,597 5mg QD|Administered orally, once daily with morning meal for duration of trial (84 days).
16314304|NCT00541996|Drug|vabicaserin|
16314305|NCT00541983|Drug|XOMA 052|Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
16314306|NCT00541983|Drug|Placebo|Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
16314307|NCT00541970|Biological|Cervarix|Intramuscular injection, different dosing /schedule
16314308|NCT00541970|Drug|Placebo|Intramuscular injection, different dosing /schedule
16314309|NCT00541957|Behavioral|behavior therapy|10 sessions over 4 months
16314310|NCT00541957|Drug|Medication prescribed by PCP|Can include any antidepressant medication
16314311|NCT00541931|Drug|Dietary Supplement: LifePak Nano|Daily use
16314312|NCT00541918|Drug|Diprivan (propofol, Astra Zeneca)|Total intravenous anesthesia with propofol
16314313|NCT00541918|Drug|Sevorane (sevoflurane, Abbott)|inhaled anesthesia with sevoflurane
16314314|NCT00541905|Drug|NT 201|Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.
16314315|NCT00541892|Other|Medium with no human serum albumine added|See above
16314316|NCT00541892|Other|Conventional medium|See above
16314317|NCT00541879|Behavioral|Program ENERGY|Weekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented
16314318|NCT00541879|Other|comparison|
16314319|NCT00541866|Drug|Voreloxin injection and cytarabine|"Dose-escalation Phase
~Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion of 400 mg/m2/day × 5 days)
~Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
~Expansion Phase The MTD determined in the dose-escalation phase was used in the expansion phase.
~Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
~Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)"
16314320|NCT00541853|Drug|Candesartan|Candesartan upto 8mg
16314321|NCT00541853|Drug|Candesartan and Cilnidipine|Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
16314322|NCT00541853|Drug|Candesartan plus non-CCB agents|Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI
16314323|NCT00541840|Drug|Sorafenib|"Phase I:
~Level 1: Sorafenib 200 mg bid, orally Ifosfamide 2,0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Level 2: Sorafenib 400 mg bid, orally Ifosfamide 2.00 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Level 3 : Sorafenib 400mg bid, orally Ifosfamide 2.5 g/m2 , intravenously , over 4 hours , on 3 consecutive days . Mesna 500mg/m2,iv,at 0,4 and 8 hours after ifosfamide administration .
~Level 4 : Sorafenib 400 mg bid, orally Ifosfamide 3.0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 600 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
~Phase II:
~Sorafenib and Ifosfamide administered at the doses recommended in phase I until progression or unacceptable toxicity."
16314324|NCT00541814|Drug|Cyclosporine|Target drug level 50-100 ng/ml or cyclosporine withdrawal
16314325|NCT00541801|Device|Doppler-echocardiography and acoustic cardiography|Patients receive a Doppler-echocardiography and an acoustic cardiography
16314326|NCT00541788|Other|Administration of Common Sage|Administration of Common Sage
16314327|NCT00541775|Drug|Sitagliptin|Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
16314328|NCT00541775|Drug|Comparator: Rosiglitazone|Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
16314329|NCT00541775|Drug|Comparator: Placebo|placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
16314330|NCT00541775|Drug|Comparator: Metformin|Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
16314331|NCT00541762|Dietary Supplement|Fat perfusion to the small intestine|"Triglycerides, long chain fatty acids, medium chain fatty acids perfused to the small intestine
~Orlistat perfused to the small intestine
~DEXLOX as CCK-1 receptor antagonist"
16314332|NCT00541749|Drug|rhuMAb IFNalpha|Intravenous repeating dose
16314333|NCT00541736|Drug|Nitroglycerine|Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
16314334|NCT00541723|Drug|IncobotulinumtoxinA (Xeomin)|Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
16314335|NCT00541723|Drug|Placebo|Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
16314336|NCT00541710|Dietary Supplement|genistein|pills of 27 mg, twice per day for 12 months
16314337|NCT00541710|Dietary Supplement|placebo|sugar pills twice per day for 12 months
16314338|NCT00541697|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|
16314339|NCT00541697|Drug|Comparator: atorvastatin / Duration of Treatment: 6 Weeks|
16314340|NCT00541684|Drug|MK0954, /Duration of Treatment : 16 Weeks|
16314341|NCT00541684|Drug|Comparator : atenolol /Duration of Treatment : 16 Weeks|
16314342|NCT00541671|Drug|Saline|10 c of saline
16314343|NCT00541671|Drug|Phenergan|Physician ordered dose
16314344|NCT00541658|Drug|risedronate|5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
16314345|NCT00541658|Drug|risedronate|35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
16314346|NCT00541658|Drug|risedronate|35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
16314347|NCT00541606|Other|Pharmacist collaboration in diabetes care|Patients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12.
16314348|NCT00541606|Other|Usual care|Control patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period.
16314349|NCT00541593|Procedure|Pancreatic Pseudocystgastrostomy|An operation to connect the pancreatic pseudocyst to the stomach so it can drain into the stomach and intestines
16314350|NCT00541567|Drug|ibipinabant|oral, tablet, once daily
16314351|NCT00541554|Drug|Abilify (aripiprazole)|
16314352|NCT00541541|Procedure|Phrenic nerve stimulation|Patients receive a phrenic nerve stimulation
16314353|NCT00541515|Device|continuous glucose sensors and insulin pump|continuous glucose sensors and insulin pump
16314354|NCT00541489|Drug|Naproxcinod|750 mg, bid
16314355|NCT00541489|Drug|Naproxen|500 mg, bid
16314356|NCT00541489|Drug|Placebo|bid
16314357|NCT00541463|Drug|MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks|
16314358|NCT00541463|Drug|Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks|
16314359|NCT00541450|Drug|Comparator: sitagliptin phosphate (sitagliptin)|sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period
16314360|NCT00541450|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period
16314361|NCT00541450|Drug|Comparator: pioglitazone|pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.
16314362|NCT00541450|Drug|Matching placebo to pioglitazone|"matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.
~Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks."
16314363|NCT00541450|Drug|Matching placebo to sitagliptin|matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.
16314364|NCT00541450|Drug|Matching Placebo to Sita/Met FDC|matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
16314365|NCT00541424|Procedure|PET/CT Scanning|Full-body PET/CT procedure will be performed. Gas will be pumped into the colon before the scan so the colon will be opened up (inflated) and the study doctor will be able to more easily look for any lesions. This procedure is called gas insufflation.
16314366|NCT00541411|Drug|Vincristine, Actinomycin-D, Ifosfamide|Chemotherapy
16314367|NCT00541398|Behavioral|Implementation of guideline|Outreach visits with interactive education for health staff
16314368|NCT00541385|Drug|pyronaridine artesunate|The strength of the granule formulation is 60:20 mg pyronaridine artesunate per sachet. Depending on their body weight, patients will receive between 1 to 3 pyronaridine artesunate sachets per day, for 3 consecutive days The actual dose-range covered by this regimen is 7.0:2.3 mg/kg to 13.3:4.4 mg/kg pyronaridine artesunate, which has shown to be effective and safe in the phase II studies conducted in children and adults.
16314369|NCT00541385|Drug|arthemeter lumefantrine|"Artemether 20 mg and lumefantrine 120 mg fixed dose combination, 6 dose regimen 120 mg artemether and 720 mg lumefantrine total (Novartis).
~The posology is twice daily for 3 consecutive days 1 tablet for patients weighing ≥5 kg to <15 kg, 2 tablets for patients weighing ≥15 to <25 kg."
16314447|NCT00540982|Drug|lidocaine|1 mg/kg will be administered to determine metabolic capacity
16314370|NCT00541372|Device|insulin injection needle size|The intervention in this study is a specific needle with a length of 5 mm and 8 mm to be used with an insulin pen.
16314371|NCT00541359|Drug|bortezomib|Given IV
16314372|NCT00541359|Drug|topotecan hydrochloride|Given IV
16314373|NCT00541359|Other|immunohistochemistry staining method|Correlative studies
16314374|NCT00541359|Other|pharmacological study|Correlative studies
16314375|NCT00541346|Drug|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
16314376|NCT00541333|Drug|Copaxone Injection|
16314377|NCT00541320|Drug|GW813893|
16314378|NCT00541307|Device|Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface|Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
16314379|NCT00541281|Drug|docetaxel|35mg/m² on day 2 and 9 (21days in a cycle)
16314380|NCT00541281|Drug|estramustine|140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle
16314381|NCT00541281|Drug|prednisone|2x5 mg a day
16314382|NCT00541268|Device|ICD|Intracardioverter defibrillators from 2 different manufacturers
16314383|NCT00541268|Other|Optimal medical treatment|ACEi or angiotensin receptor blockers Betablockers Aldosterone blockers
16314384|NCT00541242|Drug|bimatoprost 0.03% eye drops|Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
16314385|NCT00541242|Drug|latanoprost 0.005% eye drops|Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
16314386|NCT00541229|Drug|sitagliptin phosphate|sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
16314387|NCT00541229|Drug|sitagliptin phosphate|sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
16314388|NCT00541229|Drug|Comparator: Placebo|sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
16314389|NCT00541216|Drug|Ephedrine|
16314390|NCT00541190|Other|Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA|Subjects perform a single nuclear medicine scan after inhaling an aerosol containing Technetium 99m sulfur colloid and Indium 111 DTPA.
16314391|NCT00541177|Drug|atropine|0.25% atropine
16314392|NCT00541177|Drug|tropicamide|0.5% tropicamide
16314393|NCT00541164|Drug|Coenzyme Q10|300 mg CoQ10 twice a day for 48 weeks
16314394|NCT00541164|Dietary Supplement|Coenzyme Q10|300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
16314395|NCT00541151|Device|MiniArc|sling system
16314396|NCT00541138|Drug|carboplatin|CBDCA AUC=3
16314397|NCT00541138|Drug|tamoxifen citrate|Tamoxifen 100mg bid
16314398|NCT00541138|Drug|topotecan hydrochloride|Topotecan 0.75 g/m2/d
16314399|NCT00541138|Other|pharmacological study|Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.
16314400|NCT00541125|Biological|bevacizumab|
16314401|NCT00541125|Biological|filgrastim|
16314402|NCT00541125|Drug|fluorouracil|
16314403|NCT00541125|Drug|irinotecan hydrochloride|
16314404|NCT00541125|Drug|leucovorin calcium|
16314405|NCT00541112|Biological|cetuximab|
16314406|NCT00541112|Drug|capecitabine|
16314407|NCT00541112|Drug|fluorouracil|
16314408|NCT00541112|Drug|leucovorin calcium|
16314409|NCT00541112|Drug|oxaliplatin|
16314410|NCT00541112|Procedure|adjuvant therapy|
16314411|NCT00541112|Procedure|conventional surgery|
16314412|NCT00541112|Procedure|neoadjuvant therapy|
16314413|NCT00541112|Radiation|radiation therapy|
16314414|NCT00541099|Biological|bevacizumab|Avastin 10.0 mg/kg on days 1 and 15
16314415|NCT00541099|Drug|docetaxel|Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
16314416|NCT00541086|Drug|anastrozole|1 mg per day, orally
16314417|NCT00541086|Drug|exemestane|25 mg per day, orally
16314418|NCT00541086|Drug|letrozole|2.5 mg per day, orally
16314419|NCT00541086|Drug|tamoxifen citrate|20 mg per day, orally
16314420|NCT00541073|Dietary Supplement|vitamin B12|
16314421|NCT00541073|Drug|cisplatin|
16314422|NCT00541073|Drug|pemetrexed disodium|
16314423|NCT00541073|Genetic|gene expression analysis|
16314424|NCT00541073|Other|laboratory biomarker analysis|
16314425|NCT00541073|Other|pharmacological study|
16314426|NCT00541060|Genetic|mutation|a mutation of a gene coding
16314427|NCT00541047|Drug|bicalutamide|
16314428|NCT00541047|Drug|goserelin acetate|
16314429|NCT00541047|Drug|leuprolide acetate|
16314430|NCT00541047|Procedure|adjuvant therapy|
16314431|NCT00541047|Procedure|quality-of-life assessment|
16314432|NCT00541047|Radiation|radiation therapy|
16314433|NCT00541034|Biological|rituximab|
16314434|NCT00541034|Drug|cyclophosphamide|
16314435|NCT00541034|Drug|pentostatin|
16314436|NCT00541021|Drug|gemcitabine hydrochloride|
16314437|NCT00541021|Drug|sorafenib tosylate|
16314438|NCT00541008|Drug|sunitinib malate|
16314439|NCT00540995|Drug|busulfan|Given IV
16314440|NCT00540995|Drug|etoposide|Given IV
16314441|NCT00540995|Radiation|intensity-modulated radiation therapy|Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
16314442|NCT00540995|Procedure|allogeneic hematopoietic stem cell transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
16314443|NCT00540995|Procedure|allogeneic bone marrow transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
16314444|NCT00540995|Procedure|peripheral blood stem cell transplantation|Stem cell transplantation occurs on Day 0 after High Dose Therapy
16314445|NCT00540995|Radiation|tomotherapy|Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
16314446|NCT00540982|Drug|indocyanine green|0.5 mg/kg will be administered by IV push to determine clearance
16314589|NCT00539929|Drug|E6201 0.005%|
16314448|NCT00540982|Drug|vinorelbine ditartrate|Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
16314449|NCT00540982|Other|high performance liquid chromatography|Used to determine plasma concentrations of vinorelbine
16314450|NCT00540982|Other|intracellular fluorescence polarization analysis|Used to determine concentration of lidocaine metabolic capacity
16314451|NCT00540982|Other|liquid chromatography|Used to determine concentrations of vinorelbine and its metabolites
16314452|NCT00540982|Other|mass spectrometry|Used to determine concentrations of vinorelbine and its metabolites
16314453|NCT00540982|Other|pharmacological study|Determination of concentrations of vinorelbine and its metabolites
16314454|NCT00540969|Procedure|cryosurgery|Patients undergo cryosurgery using guidance from CT scan or ultrasound
16314455|NCT00540969|Radiation|radiation therapy|Patients undergo radiotherapy for 1 week
16314456|NCT00540956|Drug|cytarabine|
16314457|NCT00540956|Other|laboratory biomarker analysis|
16314458|NCT00540943|Drug|Pazopanib|Pazopanib is a potent, multi-targeted tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit.
16314459|NCT00540943|Drug|Cetuximab|"Cetuximab will be supplied as a single-use 50 milliliter vial containing 100 micrograms of cetuximab as a sterile, preservative-free, injectable liquid at a concentration of 2 milligram per milliliter in phosphate.
~buffered saline"
16314460|NCT00540943|Drug|Irinotecan|Irinotecan hydrochloride trihydrate is an antineoplastic agent of the topoisomerase I inhibitor class.
16314461|NCT00540930|Drug|Ranibizumab|Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
16314462|NCT00540917|Procedure|cooling spray during laser treatment|skin temperature measurement
16314463|NCT00540904|Drug|sodium bicarbonate|IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
16314464|NCT00540904|Drug|NaCl|IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
16314465|NCT00540891|Drug|ALFUZOSIN|
16314466|NCT00540878|Drug|SB-751689 oral tablets (400 mg)|
16314467|NCT00540865|Behavioral|Problem-solving therapy (PST)|The premise of PST is that psychotherapies implicitly help people to become better managers of their lives, in effect, to become better at solving problems. Unlike Case Management (CM) that seeks to increase its clients' availability and utilization of resources, PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment. Although CM and PST have different theoretical premises, they both focus on the resolution of concrete problems promoting depression.
16314468|NCT00540865|Behavioral|Case management (CM)|Different types of CM exist, but all share the theme of helping individuals cope with their illnesses through linkage to social services, advocacy, rehabilitation, and ongoing support during recovery from illnesses. CM will consist of the following components: 1) socialization to treatment; 2) needs assessment; 3) psychoeducation about depression; 4) service planning; 5) linkage to social services; 6) help with access to health care; 7) advocacy; and 8) exploration of barriers that perpetuate unmet needs.
16314469|NCT00540852|Device|Diffuse Optical Spectroscopy Imaging|Diffuse Optical Spectroscopy Imaging
16314470|NCT00540839|Drug|Montelukast sodium|Montelukast 4 mg OG or montelukast 4 mg CT
16314471|NCT00540839|Drug|Placebo to montelukast|Placebo OG or CT
16314472|NCT00540839|Drug|Fluticasone propionate|Fluticasone 50 mcg inhalation aerosol metered dose inhaler
16314473|NCT00540839|Drug|Placebo to fluticasone|Placebo inhalation aerosol metered dose inhaler
16314474|NCT00540826|Drug|Atomoxetine|in-label use
16314475|NCT00540826|Drug|stimulants (any approved ADHD medication)|in-label use
16314476|NCT00540813|Device|drug eluting balloon|drug eluting balloon bifurcated coronary lesions single arm study
16314477|NCT00540800|Drug|docetaxel|given in combination with epirubicin or capecitabine
16314478|NCT00540800|Drug|epirubicin|for patients with locally advanced breast cancer, or metastatic breast cancer not previously treated with anthracyclines
16314479|NCT00540800|Drug|capecitabine|for metastatic breast cancer patients previously treated with anthracyclines
16314480|NCT00540787|Device|Radiofrequency ablation, antiarrhythmic drugs|Patients receive either treatment.
16314481|NCT00540787|Drug|Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs|Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.
16314482|NCT00540787|Device|ThermoCool Radiofrequency Catheter|Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.
16314483|NCT00540774|Device|detection of oral pathology|detection of oral pathology
16314484|NCT00540761|Device|OFDI imaging|Intervention of OFDI system and Imaging of the culprit lesion using the OFDI system.
16314485|NCT00540748|Drug|oxytocin|5 U i.v. during surgical abortion
16314486|NCT00540735|Procedure|photodynamic therapy|
16314487|NCT00540722|Drug|R-(-)-gossypol acetic acid|Given PO
16314488|NCT00540722|Other|laboratory biomarker analysis|Correlative studies
16314489|NCT00540709|Drug|Insulin Glargine|
16314490|NCT00540696|Drug|darbepoetin alfa|"Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses.
~Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses."
16314491|NCT00540683|Device|Diffuse Optical Spectroscopy|Muscle properties
16314492|NCT00540670|Drug|E5555 50 mg|E5555 50 mg (tablet) taken orally, once a day.
16314493|NCT00540670|Drug|E5555 100 mg|E5555 100 mg (tablet) taken orally, once a day.
16314494|NCT00540670|Drug|E5555 200 mg|E5555 200 mg (tablet) taken orally, once a day.
16314495|NCT00540670|Drug|Placebo|Placebo (tablet) taken orally, once a day.
16314496|NCT00540657|Drug|CCX282-B|250mg capsule, twice daily, 13 weeks
16314497|NCT00540657|Drug|Placebo|Placebo capsule, twice daily, 13 weeks
16314498|NCT00540644|Drug|lenalidomide (Revlimid®)|25 mg p.o. daily on days 1-21 of each 28 day cycle
16314499|NCT00540644|Drug|Cyclophosphamide|50 mg p.o. BID daily on days 1-21 of each 28 day cycle
16314500|NCT00540644|Drug|Prednisone|50 mg p.o. Q.O.D.
16314501|NCT00540631|Biological|specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)|"Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
~to be det. A 0.1 100 TU
~7 (+7) days later A 0.2 200 TU
~7 (+7) days later A 0.4 400 TU
~7 (+7) days later A 0.6 600 TU
~7 (+7) days later B 0.1 1000 TU
~7 (+7) days later B 0.2 2000 TU
~7 (+7) days later B 0.4 4000 TU
~7 (+7) days later B 0.6 6000 TU
~Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
~to be det. A 0.1 100 TU
~7 (+7) days later A 0.2 200 TU
~7 (+7) days later A 0.4 400 TU
~7 (+7) days later A 0.6 600 TU
~7 (+7) days later B 0.1 1000 TU
~7 (+7) days later B 0.2 2000 TU
~7 (+7) days later B 0.4 4000 TU
~7 (+7) days later B 0.6 6000 TU
~Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued"
16314502|NCT00540618|Drug|MEDI-507|Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
16314503|NCT00540618|Other|Placebo|
16314504|NCT00540618|Drug|MEDI-507|Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
16314505|NCT00540618|Drug|MEDI-507|Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
16314507|NCT00540592|Biological|GlaxoSmithKline Biologicals' influenza vaccine GSK576389A|Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
16314508|NCT00540592|Biological|Fluarix|Single dose, Intramuscular injection
16314509|NCT00540579|Drug|Pomalidomide|Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21
16314510|NCT00540579|Drug|Gemcitabine|1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle
16314511|NCT00540566|Device|Optical Biopsy imaging|Optical Biopsy imaging
16314512|NCT00540553|Drug|placebo|
16314513|NCT00540553|Drug|GSK971086|
16314514|NCT00540540|Device|Diffuse Optical Spectroscopy|Breast properties scanning
16314515|NCT00540527|Drug|local interarterial recombinant tissue plasminogen activator|Endovascular treatment must be performed asap after random.and definitely within 6h from symp. onset.It includes intrarterial thrombolysis with rt-PA,if necessary,associated to or substituted by mechanical clot disruption and/or retrieval.Fibrinolytic therapy should be performed within 1h,the full dose of rt-PA infusion should not exceed 0.9 mg/kg (max 90 mg in the case of body weight ≥100 kg).If a complete recanalization is achieved,rt-PA infusion can be interrupted before reaching the maximum dosage.The option of performing a thrombolysis by mechanical means to obtain a mechanical disintegration/shift/detach/fissure of the thrombus and/or a retraction/aspiration can be considered on the basis of the type,location and characteristics of the occlusion.These choices may involve the use of the microguidewire as a mechanical instrument to favour the disintegration of the thrombus,using systems to capture the thrombus by extraction or more complex systems to crush and aspirate the thrombus
16314516|NCT00540527|Drug|intravenous (IV) rt-PA|IV thrombolytic treatment is started immediately after randomization, within 4.5 h of symptoms onset. IV rt-PA is administered at a dose of 0.9 mg/kg (max 90 mg), 10% of which is given as a bolus, followed by the delivery of the remaining 90% as a constant infusion over 60 mins
16314517|NCT00540514|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion.
16314518|NCT00540514|Drug|Paclitaxel|Administered by intravenous infusion.
16314519|NCT00540514|Drug|Carboplatin|Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate [GFR] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).
16314520|NCT00540501|Drug|Oseltamivir and Intravenous Zanamivir|"Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.
~Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.
~Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes."
16314521|NCT00540488|Other|Adult enteral formula|
16314522|NCT00540462|Procedure|gastric bypass|
16314523|NCT00540462|Procedure|sleeve gastrectomy|
16314524|NCT00540449|Drug|TMC278|25 mg tablet once daily for 96 weeks
16314525|NCT00540449|Drug|Efavirenz|600mg once daily for 96 weeks
16314526|NCT00540436|Drug|GSK1325760A|Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.
16314527|NCT00540423|Drug|SB-497115-GR 12.5mg|SB-497115-GR 12.5mg tablet once a day
16314528|NCT00540423|Drug|SB-497115-GR 25mg|SB-497115-GR 25mg tablet once a day
16314529|NCT00540423|Drug|SB-497115-GR 12.5mg matching placebo|SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day
16314530|NCT00540423|Drug|SB-497115-GR 50 mg|SB-497115-GR 25mg tablet x2 once a day
16314531|NCT00540410|Drug|Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)|Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
16314532|NCT00540410|Drug|Coartem® (arthemether+ lumefantrine)|"Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.
~Duration of treatment: 3 days"
16314533|NCT00540397|Drug|Fuzhenghuayu Tablet, Huangqi Decoction Granule|
16314534|NCT00540384|Drug|Placebo|Placebo
16314535|NCT00540384|Drug|Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)|Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
16314536|NCT00540371|Other|Port wine stain Birthmark|Port wine stain Birthmark
16314537|NCT00540358|Drug|gemcitabine/carboplatin|Gemcitabine and carboplatin administered according to instructions in the package inserts.
16314538|NCT00540358|Drug|iniparib|"Body weight adjusted dose
~1 hour intravenous infusion"
16314539|NCT00540345|Drug|pegylated interferon alpha 2a and plus ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks
16314540|NCT00540345|Drug|Pegylated interferon alfa-2a and ribavirin|pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks
16314541|NCT00540345|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16314542|NCT00540345|Drug|pegylated interferon alpha 2a and ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
16314543|NCT00540332|Drug|Placebo|Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
16314544|NCT00540332|Drug|palifermin|120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course
16314545|NCT00540319|Behavioral|HIP|"The Health in Pregnancy (HIP) computer program provides tailored, interactive Video Doctor counseling about behavioral risks, educational worksheets for the patients, and a cueing sheet for providers."
16314546|NCT00540306|Device|Diffuse Optical Spectroscopy|Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
16314547|NCT00540293|Drug|Atorvastatin|Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
16314548|NCT00540280|Radiation|Surgery alone or surgery plus preoperative Gemcitabine-Cisplatin|Surgery + Chemo + RT
16314549|NCT00540267|Other|No Intervention|No Intervention
16314550|NCT00540254|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems
16314551|NCT00540254|Other|Usual Care for Chronic Fatigue Syndrome (Active Control Group)|Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs
16314552|NCT00540241|Drug|Pemetrexed|in-label use
16314553|NCT00540228|Biological|Influenza Vaccine GSK1247446A - 4 different formulations|Single dose, Intramuscular injection
16314554|NCT00540228|Biological|Fluarix™|Single dose, Intramuscular injection
16314555|NCT00540215|Other|Glucagonlike peptide|450 nmol native form, synthetic
16314556|NCT00540202|Drug|artemether-lumefantrine|Tablets taken twice daily for 3 days according to weight based guidelines.
16314557|NCT00540202|Drug|Oral quinine|Quinine tablets given at 10mg/kg 8 hourly for 7 days
16314558|NCT00540189|Procedure|Initial appendectomy|
16314559|NCT00540189|Procedure|Interval appendectomy|
16314560|NCT00540176|Drug|Dichloroacetate (DCA)|Oral DCA given twice daily for the 24 week period of the study. Continuation of therapy will be indefinite if efficacious.
16314561|NCT00540150|Biological|specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)|We treat each patient with mite-allergen following the two different protocols.
16314562|NCT00540137|Drug|nevirapine|400mg once daily
16314563|NCT00540137|Drug|atazanavir/ritonavir|atazanavir 300 mg once daily ritonavir 100 mg once daily
16314564|NCT00540124|Drug|Tadalafil|5 mg once a day
16314565|NCT00540124|Drug|Placebo|once a day
16314566|NCT00540124|Drug|Tamsulosin|0.2 mg once a day
16314567|NCT00540111|Dietary Supplement|soluble fiber® (partially hydrolyzed guar gum)|HIV-positive individuals with hypertriglyceridemia and who had been on the same HAART regimen for at least 6 months, had no change in therapy during the study,received 20g/day of soluble fiber for 4 months at pre-established times.
16314568|NCT00540098|Drug|paroxetine + aerobic exercise|paroxetine, 40 mg once daily + regular aerobic exercise
16314569|NCT00540098|Drug|Paroxetine + relaxation|paroxetine, 40 mg once daily + regular relaxation training
16314570|NCT00540098|Drug|Placebo + aerobic exercise|placebo pill once daily + regular aerobic exercise
16314571|NCT00540098|Drug|Placebo + relaxation|placebo pill once daily + regular relaxation training
16314572|NCT00540085|Drug|Rocuronium|0.6 mg/kg given intravenously before intubation
16314573|NCT00540072|Drug|daptomycin|
16314574|NCT00540046|Device|Copper T 380A IUD|Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
16314575|NCT00540033|Dietary Supplement|infloran|Study group was fed with probiotics as infloran 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;
16314576|NCT00540033|Dietary Supplement|infloran|Study group was fed with infloran [Lactobacilli acidophilus (CFU 109 NCDO 1748, obtained from the National Collection of Dairy Organisms)] and Bifidobacteria bifidum [(CFU 109, NCDO 1453 obtained from the National Collection of Dairy Organisms)]; Laboratorio Farmaceutico S.I.T S.r.I ITALY] 125mg/kg/dose twice daily by adding it to breast milk or mixed feeding (breast and formula) for 6 weeks;
16314577|NCT00540020|Other|Rehabilitation|
16314578|NCT00540007|Drug|Lenalidomide|
16314579|NCT00539994|Drug|retapamulin|200mg BID retapamulin 3 days
16314580|NCT00539994|Drug|Retapamulin|200mg BID retapamulin 5 days
16314581|NCT00539994|Drug|Placebo|200mg BID placebo 5 days
16314582|NCT00539981|Biological|FluBlok®|Dose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004
16314583|NCT00539981|Biological|Placebo|Dose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular
16314584|NCT00539968|Drug|Docetaxel plus lonafarnib|"Docetaxel: 60-75 mg/m2
~Lonafarnib: 150-375 mg PO BID"
16314585|NCT00539955|Behavioral|Standard Batterer Intervention|Standard state-mandated batterer intervention program (40 hours)
16314586|NCT00539955|Behavioral|Brief Alcohol Intervention|Brief alcohol intervention combined with state mandated batterer intervention program
16314587|NCT00539942|Drug|Arixtra (fondaparinux sodium)|Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.
16314588|NCT00539942|Device|Intermittent compression devices (ICD)|All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
16314593|NCT00539916|Behavioral|Regular orange juice consumption|600 mL /day.
16314594|NCT00539903|Behavioral|Physical activity (PA) and immigrants|
16314595|NCT00539890|Drug|Technosphere Insulin|
16314596|NCT00539877|Drug|irinotecan|"Postoperative day 1, IP CPT-11 chemotherapy will be given by CAPD catheter. CPT-11 in 1L of normal saline, prewarmed to 37°C will be given intraperitoneally.
~If there is no DLT and patients agree with the treatment, patients can receive 3 more times of IP chemotherapy with same dose of CPT-11 at 3 weeks interval. After total 4 cycles of IP chemotherapy, peritoneal disease will be reassessed with abdominal-pelvis CT. Pharmacokinetic study is not planned with this treatment."
16314597|NCT00539864|Biological|FluBlok Influenza Vaccination|0.5mL dose for intramuscular injection
16314598|NCT00539864|Biological|TIV (Fluzone) Influenza Vaccination|0.5mL dose for intramuscular injection
16314599|NCT00539838|Drug|Prednisone|Oral repeating dose
16314600|NCT00539838|Drug|Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)|Oral repeating dose
16314601|NCT00539838|Drug|Methylprednisolone|Intravenous repeating dose
16314602|NCT00539838|Drug|Ocrelizumab|Intravenous repeating dose
16314603|NCT00539838|Drug|Placebo|Intravenous repeating dose
16314604|NCT00539825|Drug|GSK704838|
16314605|NCT00539812|Behavioral|Standard Care|Standard 40 hour state mandated batterer intervention program
16314606|NCT00539812|Behavioral|Brief Alcohol Intervention combined with standard care|Brief alcohol intervention combined with standard 40 hour state mandated batterer intervention program
16314607|NCT00539799|Drug|prednisolone|5 - 7.5 mg/day
16314608|NCT00539799|Drug|Placebo|Matched placebo to prednisolone
16314609|NCT00539786|Drug|Proton pump inhibitor (rabeprazole)|Patients receives rabeprazole 20mg AM and 20mg PM for 14 days
16314610|NCT00539773|Drug|BCG, Interferon|Chemotherapy
16314611|NCT00539760|Drug|GSK1827771|GSK1827771 will be administered using injection via subcutaneous (SC) route.
16314612|NCT00539760|Drug|Placebo|Placebo to GSK1827771 for Injection will be administered via SC route
16314613|NCT00539734|Drug|ranibizumab|A single dose of 0.5 mg ranibizumab injected intravitreally.
16314614|NCT00539721|Drug|Rolapitant Dose 1|Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
16314615|NCT00539721|Drug|Rolapitant Dose 2|Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
16314616|NCT00539721|Drug|Rolapitant Dose 3|Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
16314617|NCT00539721|Drug|Rolapitant Dose 4|200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
16314618|NCT00539721|Drug|Ondansetron|Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
16314619|NCT00539721|Drug|Placebo|Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
16314620|NCT00539708|Procedure|Non-invasive ventilation|Non-invasive ventilation after extubation for 24 hours
16314621|NCT00539695|Biological|IL-2|"IL2 Administration:
~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as 'week beginning with first IL-2 injection."
16314622|NCT00539669|Drug|Docetaxel|
16314623|NCT00539656|Biological|Ex vivo expansion of cord blood|Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
16314624|NCT00539643|Device|Bead Block microspheres|Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
16314625|NCT00539643|Other|Bead + Dox Arm|Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
16314626|NCT00539630|Drug|Docetaxel|
16314627|NCT00539617|Drug|Erlotinib|Tarceva single agent therapy: 150 mg/day PO
16314628|NCT00539617|Drug|5-fluorouracil|5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks
16314629|NCT00539617|Drug|Leucovorin|400 mg/m2 IV once every 2 weeks for 16 weeks
16314630|NCT00539617|Drug|Oxaliplatin|85 mg/m2 IV once every 2 weeks for 16 weeks
16314631|NCT00539604|Procedure|MDCT and Coronary Angiography|
16314632|NCT00539591|Drug|Peginterferon alfa-2b|Given either IV or SQ. Therapeutic drug class: interferon.
16314633|NCT00539591|Drug|Temozolomide|Given PO. Therapeutic drug class: antineoplastic agent.
16314634|NCT00539591|Drug|Recombinant interferon alfa-2b|Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon
16314635|NCT00539578|Drug|MK0777|Duration of Treatment: 4 weeks
16314636|NCT00539578|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 4 weeks
16314637|NCT00539565|Drug|prednisolone|"2 mg/kg /day from post-op day 7 - day 21
~1 mg/kg /day from post-op day 22 - day 30"
16314638|NCT00539565|Drug|placebo|
16314639|NCT00539539|Other|Laerdal Q-CPR /technology|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
16314640|NCT00539526|Drug|Bimatoprost 0.03%|bimatoprost 0.03%, 1 drop nightly for 3 months
16314641|NCT00539526|Drug|travoprost 0.004%|travoprost 0.004% eye drops, 1 drop nightly for 3 months
16314642|NCT00539526|Drug|latanoprost 0.005% eye drops|latanoprost 0.005%, 1 drop nightly for 3 months
16314643|NCT00539513|Drug|N-Acetylcysteine|3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks
16314644|NCT00539513|Drug|placebo|placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks
16314645|NCT00539500|Drug|Carboplatin|Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.
16314646|NCT00539500|Drug|Etoposide|300 mg/m^2 by vein over 24 hours for 4 days
16314647|NCT00539500|Drug|Melphalan|70 mg/m^2 Intravenous Bolus for 3 Days
16314648|NCT00539500|Procedure|Stem Cell Infusion|Stem Cell Infusion (approximately 5x10^8 TNC cells/kg CD133+ selected) on Day 0.
16314649|NCT00539500|Device|ClinicMACS|Device used to process the blood and separate the CD 133+ cells needed for transplantation
16314650|NCT00539474|Procedure|Radio guided occult lesion localisation|ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire
16314651|NCT00539448|Drug|insulin glargine|in combination with insulin Glulisine as bolus regimen
16314652|NCT00539448|Drug|insulin glulisine|in combination with insulin Glargine as bolus regimen
16314653|NCT00539435|Procedure|Intravenous Insulin on cardiac disease in diabetic pts|Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
16314654|NCT00539422|Genetic|pcr and serum markers for breast cancer|DNA extraction and genotyping of cytochrome P450-2D6*4 gene using conventional PCR followed by restriction enzyme (Mva1) digestion. Separated plasma was used for measurement of plasma malondialdehyde(MDA)concentration, total plasma antioxidant capacity and plasma ferretin level.
16314655|NCT00539409|Procedure|Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)|Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
16314656|NCT00539396|Drug|Technosphere Insulin|
16314657|NCT00539383|Drug|ANG1005|IV infusion once every 21 days
16314658|NCT00539357|Device|Cranial electrotherapy stimulation (CES)|Cranial electrotherapy stimulation (CES) is a noninvasive procedure that involves applying a pulsed, low-amplitude electrical current to the head using electrodes placed on the earlobes. Cranial electrotherapy stimulation CES received U.S. Food and Drug Administration (FDA) approval for the treatment of insomnia, depression, and anxiety in 1979.
16314659|NCT00539344|Drug|ANG1005|IV infusion once every 21 days
16314660|NCT00539331|Drug|AZD2171|oral tablet
16314661|NCT00539331|Drug|Paclitaxel|intravenous infusion
16314662|NCT00539331|Drug|Carboplatin|intravenous injection
16314663|NCT00539318|Procedure|Blood drawing|Once when enroll in study
16314664|NCT00539305|Drug|testosterone gel|50-100mg applied topically daily for six months
16314665|NCT00539305|Drug|placebo gel|applied topically daily for six months
16314666|NCT00539292|Procedure|Primary placement of a spring-loaded silo|
16314667|NCT00539292|Procedure|Primary Closure|primary closure of abdomen
16314668|NCT00539279|Behavioral|Prolonged Exposure Therapy (PE)|PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
16314669|NCT00539279|Behavioral|Relaxation Training (RT)|RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
16314670|NCT00539266|Biological|bone marrow derived mononuclear cells|40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
16314671|NCT00539266|Biological|placebo|40 IM injections (calf muscle) of placebo suspension
16314672|NCT00539253|Drug|gadobenate dimeglumine (MultiHance)|The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
16314673|NCT00539240|Drug|Rabeprazole 20mg, placebo dinner and bedtime|Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
16314674|NCT00539240|Drug|Rabeprazole 20 mg two times, Placebo at bedtime|Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
16314675|NCT00539240|Drug|Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant|Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
16314676|NCT00539227|Procedure|NAC Sparing Mastectomy|A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).
16314677|NCT00539227|Behavioral|Questionnaire|Questionnaires taking about 20-30 minutes to complete.
16314678|NCT00539201|Drug|GSK706769|
16314679|NCT00539188|Drug|N-Acetylcysteine|3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
16314680|NCT00539188|Drug|placebo|placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
16314681|NCT00539175|Device|infrared light|pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy
16314682|NCT00539175|Device|infrared light; placebo|patients will be exposed to the same machine used to provide pulsed infrared light, but the light emitting diodes will not be activated. All other aspects of the treatment will be the same. The patient and investigator will be blind to treatment assignment.
16314683|NCT00539162|Behavioral|Questionnaire|Questionnaires completed at baseline and during each follow up visit.
16314684|NCT00539149|Drug|Amoxycillin|50 mg/kg/day twice daily
16314685|NCT00539149|Drug|Placebo equivalent to amoxycillin|50 mg/kg/d twice daily
16314686|NCT00539136|Drug|GSK561679 tablet or solution|
16314687|NCT00539123|Behavioral|behavioral drug and HIV risk reduction counseling (BDRC)|BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia.
16314688|NCT00539123|Behavioral|abstinence-contingent buprenorphine (ACB)|Participants achieving heroin abstinence documented by an opioid-negative urine test receive take-home doses of buprenorphine-naloxone, with the number of take-home doses permitted increasing depending on the number of consecutive opioid-negative urine tests. Participants who test positive receive all doses of buprenorphine-naloxone under direct observation in the clinic, using a three-times per week dosing protocol.
16314689|NCT00539110|Drug|zolipidem|zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
16314690|NCT00539110|Drug|ramelteon|ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
16314691|NCT00539097|Dietary Supplement|Juven (Ross Products) protein supplement|Juven supplement oral x 3 weeks postop
16314762|NCT00538538|Drug|vitrectomy with subretinal lucentis|These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
16314692|NCT00539084|Device|MicronJet|The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.
16314693|NCT00539071|Drug|long-acting injectable risperidone|Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).
16314694|NCT00539071|Drug|long acting injectable risperidone|Study dose remains 50 mg for the length of the study.
16314695|NCT00539071|Drug|long acting injectable risperidone|Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
16314696|NCT00539032|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16314697|NCT00539032|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16314698|NCT00539019|Other|calories measured 5x following wound healing|measure REE at various time points postburn
16314699|NCT00539006|Drug|FPNS|fluticasone propionate nasal spray
16314700|NCT00539006|Drug|FFNS|fluticasone furoate nasal spray
16314701|NCT00539006|Drug|placebo FPNS|placebo nasal spray matching fluticasone propionate nasal spray
16314702|NCT00539006|Drug|placebo FFNS|placebo nasal spray matching fluticasone furoate nasal spray
16314703|NCT00538993|Behavioral|Stage based counseling|
16314704|NCT00538980|Drug|Dasatinib|Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
16314705|NCT00538967|Drug|doxycycline|2 weeks once daily
16314706|NCT00538954|Drug|Post operative laxation (Magnesium Oxide)|20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
16314707|NCT00538954|Dietary Supplement|Preoperative metabolic conditioning postoperative nutritional supplementation|Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
16314708|NCT00538954|Other|Standard ERAS group|
16314709|NCT00538941|Dietary Supplement|Nestlé Noir intense 40 grx2|daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.
16314710|NCT00538941|Dietary Supplement|Nestlé Placebo Chocolate 40 grx2|Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.
16314711|NCT00538928|Other|lung protective ventilation|tidal volume 6 ml/kg ideal body weight
16314712|NCT00538915|Biological|Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]|Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks.
16314713|NCT00538902|Biological|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
16314714|NCT00538902|Biological|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
16314715|NCT00538902|Biological|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously every other week for 104 weeks
16314716|NCT00538889|Drug|Lecozotan SR|
16314717|NCT00538889|Drug|Citalopram|
16314718|NCT00538876|Drug|decitabine|"Decitabine will be administered by intravenous injection at a dose of 20 mg/m2/day as a daily 1hr infusion (Arm A) or by continuous infusion (Arm B) for 3, 5 or 7 days. On the day following the final dose of decitabine, standard 7+3 induction chemotherapy will begin."
16314719|NCT00538863|Drug|Fentanyl sublingual spray|Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
16314720|NCT00538850|Drug|Fentanyl sublingual spray|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.
16314721|NCT00538850|Drug|Placebo|Matching placebo to fentanyl sublingual spray.
16314722|NCT00538824|Drug|dexamethasone|"Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
~Maintenance therapy will consist of:
~• Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)"
16314763|NCT00538525|Drug|Doxorubicin, Docetaxel, Cisplatin|Doxorubicin, Docetaxel, Cisplatin
16314764|NCT00538512|Biological|Fluzone|single dose licensed trivalent inactivated influenza vaccine (2007-08)
16314765|NCT00538512|Biological|Flumist|single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
16314766|NCT00538512|Other|Physiologic saline|single dose placebo administered as an intranasal spray or intramuscular injection
16314767|NCT00538499|Drug|Fentanyl citrate|
16314723|NCT00538824|Drug|thalidomide|"Cycles 1-4
~• Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy."
16314724|NCT00538824|Drug|lenalidomide|"Cycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
~After completing 4 cycles:
~Patients who demonstrate disease progression at any time will be taken off study.
~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
~Maintenance therapy will consist of:
~• Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min*"
16314725|NCT00538811|Drug|interferon alpha-2b, ribavirin, interferon-gamma,|
16314726|NCT00538811|Drug|interferon alpha-2b, ribavirin, amantadine|
16314727|NCT00538798|Drug|[18F]SP203|
16314728|NCT00538785|Biological|Motavizumab|15 mg/kg IM administered at monthly intervals
16314729|NCT00538785|Biological|Palivizumab|15 mg/kg IM administered at monthly intervals
16314730|NCT00538772|Other|Not applicable - blood tests/tissue specimen tests will be undertaken|Not applicable - blood tests/tissue specimen tests will be undertaken
16314731|NCT00538759|Device|External beam radiation therapy|Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty
16314732|NCT00538759|Other|Sham Control|
16314733|NCT00538746|Device|BIPAP|
16314734|NCT00538746|Device|PSV|
16314735|NCT00538746|Device|PSV + CPAP|
16314736|NCT00538733|Drug|thalomid|"Cycles 1-4
~• Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)"
16314737|NCT00538733|Drug|lenalidomide|"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
~• Lenalidomide (25 mg daily days 1-21 of every 28 day cycle)
~During BiRD phase • 25mg daily days 1-21 of every 28 day cycle)
~During Maintenance Phase
~• 25 mg daily for days 1-21 out of a 28 day cycle"
16314738|NCT00538733|Drug|clarithromycin|"During T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle)
~During BiRD Phase:
~• Clarithromycin (500mg twice daily for each 28 day cycle)"
16314739|NCT00538733|Drug|dexamethasone|"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
~During BiRD Phase:
~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
~During Maintenance Phase
~• Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)"
16314740|NCT00538720|Drug|Vitamin D|Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).
16314741|NCT00538720|Device|Four-dimensional computed tomography (4DCT)|Four-dimensional computed tomography (4DCT) scan of the neck.
16314742|NCT00538707|Behavioral|2-minute Bondet test|2-minute Bondet test
16314743|NCT00538694|Drug|daptomycin|
16314744|NCT00538681|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression
16314745|NCT00538681|Drug|pemetrexed|500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
16314746|NCT00538681|Drug|cisplatin|75 mg/m², IV, every 21 days, for each 21-day cycle
16314747|NCT00538681|Drug|placebo|po, QD
16314748|NCT00538668|Drug|117Lu-J591|There will be 9 groups of patients. The first group will receive 20 units of test drug and the 9th group will receive 55 units of the test drug. The exact dose of the test drug will depend upon how many patients have been included in this protocol at the time of patient enrollment. Patients will receive 20-55 units (or millicuries) of radioactivity depending upon patient specific height and weight. The assignment of each patient for a specific dose level is purely based on the sequence of recruitment basis and does not depend on the clinical status of the patient.
16314749|NCT00538655|Drug|modafinil|400mg vs. 200mg (PO) daily
16314750|NCT00538642|Drug|ziprasidone|Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic
16314751|NCT00538629|Other|no intervention|No intervention
16314752|NCT00538616|Drug|Dexmedetomidine|in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
16314753|NCT00538616|Drug|Propofol|in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
16314754|NCT00538603|Drug|pegylated liposomal Doxorubicin (CAELYX) & Carboplatin|Chemotherapy
16314755|NCT00538603|Drug|Paclitaxel & Carboplatin|Chemotherapy
16314756|NCT00538590|Device|Collagen Matrix in Glaucoma Filtering Surgery|Collagen Matrix implantation in Glaucoma Filtering Surgery
16314757|NCT00538590|Drug|Mitomycin-C(MMC) and glaucoma filtering surgery|If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
16314758|NCT00538564|Drug|tadalafil|10mg oral tablets taken 3 times a week for 2 months
16314759|NCT00538564|Drug|placebo|Placebo tablets taken orally 3 times a week for 2 months
16314760|NCT00538551|Other|Database|Database
16314761|NCT00538538|Drug|vitrectomy with subretinal lucentis|A gas bubble will be placed in the eye after the gel has been removed.
16314885|NCT00537758|Behavioral|CBT and BWL|
16314768|NCT00538499|Drug|Bupivacaine hydrocloride|
16314769|NCT00538499|Procedure|videothoracoscopy|
16314770|NCT00538486|Drug|Telmisartan plus Metformin|Telmisartan 80mg 1/d, Metformin 250mg 2/d
16314771|NCT00538486|Drug|Telmisartan|Telmisartan 80mg 1/d
16314772|NCT00538486|Drug|Candesartan|Candesartan 8mg daily
16314773|NCT00538486|Drug|Candesartan plus Metformin|Candesartan 8mg 1/d Metformin 250mg 2/d
16314774|NCT00538486|Drug|Amlodipine|Amlodipine 5mg 1/d
16314775|NCT00538486|Drug|Amlodipine plus Metformin|Amlodipine 5mg 1/d, Metformin 250mg 2/d
16314776|NCT00538473|Biological|GSK Biologicals' influenza vaccine GSK576389A|Single dose, intramuscular injection
16314777|NCT00538473|Biological|Fluarix™|Single dose, intramuscular injection
16314778|NCT00538447|Other|Database|data base for CML
16314779|NCT00538434|Biological|Reslizumab|
16314780|NCT00538434|Other|Saline|
16314781|NCT00538421|Drug|Propofol|Infusion intravenously (IV) 0-10 mg/kg/h
16314782|NCT00538421|Drug|Sevoflurane|0,7-1,5 MAC
16314783|NCT00538408|Procedure|Whole body magnetic resonance angiography (dotarem)|
16314784|NCT00538408|Device|Whole body magnetic resonance angiography (vasovist)|
16314785|NCT00538395|Drug|Adriamycin, Taxol and Cytoxan|Chemotherapy
16314786|NCT00538382|Drug|Artesunate|A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
16314787|NCT00538369|Other|Ramsay Scale|While receiving sedation, subjects will be monitored with the Ramsay scale
16314788|NCT00538369|Device|Bispectral index monitor|While receiving sedation, subjects will receive BIS monitoring
16314789|NCT00538356|Device|ICD or CRT-D with Home Monitoring feature deactivated|Standard care
16314790|NCT00538356|Device|ICD or CRT-D with Home Monitoring feature activated|Standard care + patient management by Home Monitoring
16314791|NCT00538343|Drug|berubicin hydrochloride (RTA 744)|
16314792|NCT00538330|Drug|Tamoxifen|Tamoxifen
16314793|NCT00538317|Drug|tirofiban|bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
16314794|NCT00538317|Drug|tirofiban|bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min
16314795|NCT00538304|Drug|bimatoprost eye drops|1 drop in each eye daily for 1 month
16314796|NCT00538304|Drug|placebo|1 drop in each eye daily for 1 month
16314797|NCT00538291|Biological|cetuximab|
16314798|NCT00538291|Drug|capecitabine|
16314799|NCT00538291|Genetic|gene expression analysis|
16314800|NCT00538291|Genetic|microarray analysis|
16314801|NCT00538291|Genetic|polymorphism analysis|
16314802|NCT00538291|Genetic|reverse transcriptase-polymerase chain reaction|
16314803|NCT00538291|Other|immunohistochemistry staining method|
16314804|NCT00538278|Other|Database|database
16314805|NCT00538265|Drug|tacrolimus|Tacrolimus started at 0.50 mg/kg b.i.d. starting at D0, by nasogastric tube and then 1 to 2 hours before meals. The dose of tacrolimus will be adjusted as soon as possible to obtain trough concentrations of the product between 10 and 20 µg/L between D0 and 6 months and then between 8 and 15 µg/L after 6 months
16314806|NCT00538265|Drug|tacrolimus, ATG|"immunoprophylaxis allowing sparing of steroids in maintenance therapy combining induction therapy with 3 injections of antithymocyte globulins (ATG) (1.5 mg/kg/d at D0, D2 and D4) and tacrolimus at usual dosage.
~In this group of patients, the first injection of ATG will be infused over a period of at least 6 hours and will be started as soon as vascular anastomosis has been completed. It will be preceded by an injection of 3 mg/kg/d methylprednisolone. The second injection of ATG at D2, post transplantation will also be infused over 6 hours and will be preceded by an injection of 1 mg/kg methylprednisolone, and then subsequently steroids will be excluded from the treatment. The third and last injection at D4 post transplantation will be administered over a 6-hour period but will not be preceded by steroids.
~In this study arm, tacrolimus will be administered as in arm (A)"
16314807|NCT00538265|Drug|ATG+mycophénolate mofétil+tacrolimus|"immunoprophylaxis allowing sparing of steroids in maintenance therapy combined with mycophenolate mofetil, at an initial dosage of 2 grams a day, and then adjusted to safety and tolerability in such a way so as to maintain PMN ≥ 750/mm3, and platelet counts ≥ 30000/mm3.
~In this study arm, the patients will receive the same doses of ATG and steroids (and according to the same methods) as in arm B. Tacrolimus started at 0.05 mg/kg b.i.d. starting at D0 by nasogastric tube and then 1 to 2 hours before meals. In this study arm, the tacrolimus dose will be reduced: targeted trough concentrations will be between 7 and 12 µg/L between D0 and 6 months and then between 3 et 7 µg/L after 6 months."
16314808|NCT00538239|Drug|ridaforolimus|Four 10 mg tablets taken by mouth for 5 days per week continuously
16314809|NCT00538239|Drug|Placebo|Four 10 mg tablets taken by mouth for 5 days per week continuously
16314810|NCT00538226|Device|External Electric Muscle Stimulation|
16314811|NCT00538213|Biological|Fluarix™|Single dose, Intramuscular injection
16314812|NCT00538213|Biological|GSK Bio's Influenza Vaccine GSK576389A|Single dose, Intramuscular injection
16314813|NCT00538200|Dietary Supplement|Oral Nutritional Supplements (Fortisip)|These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 3 month period.
16314814|NCT00538200|Other|Dietary Advice|Standard dietary advice
16314815|NCT00538187|Drug|obatoclax mesylate|Given IV
16314816|NCT00538187|Drug|bortezomib|Given IV
16314817|NCT00538187|Other|laboratory biomarker analysis|correlative study
16314818|NCT00538187|Other|pharmacological study|correlative study
16314819|NCT00538174|Drug|Dapagliflozin|Tablets, Oral, once daily up, to 14 days
16314820|NCT00538174|Drug|placebo|Tablets, Oral, 0 mg, once daily, up to 14 days
16314821|NCT00538161|Other|Ventilation strategy|
16314822|NCT00538148|Drug|Telithromycin|
16314823|NCT00538135|Behavioral|Cognitive Behavioural Therapy|
16314824|NCT00538135|Other|Treatment as usual|Standard National Health Service treatment as usual for borderline personality disorder
16314886|NCT00537758|Behavioral|Behavioral Weight Loss Treatment|
16314887|NCT00537745|Drug|Vivitrol (Medication Therapy)|Vivitrol 380 mg/monthly
16315289|NCT00535119|Other|Laboratory Biomarker Analysis|Correlative studies
16314825|NCT00538122|Device|24 Holter Monitor Recording|"All subjects will be fitted with a device to obtain 24-hour Holter EKG continuous recordings of bipolar leads C5C5R. They will also receive a standard 12-lead EKG recording prior to the placement of the Holter device. The subjects will be asked to keep a diary during the course of the 24 hours to record information such as wake and sleep times and symptoms such as shortness of breath, heart palpitations, lightheadedness, etc.
~From each recording, 12 sets of 10 consecutive QRS epochs, plus QRS samplings obtained during sleep will be analyzed by a cardiologist blind to the medication status of subjects."
16314826|NCT00538109|Drug|Glivec®/Gleevec®|Chemotherapy
16314827|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
16314828|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
16314829|NCT00538096|Drug|MEDI-538|1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
16314830|NCT00538083|Other|Chocolate|74 grams of single dose solid dark chocolate versus placebo
16314831|NCT00538083|Other|Chocolate|22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo
16314832|NCT00538083|Other|Chocolate|22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks
16314833|NCT00538070|Dietary Supplement|Sarcosine|You will receive two grams of sarcosine or placebo per day. Each capsule will contain 500 mg of sarcosine or placebo. You will take two capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.
16314834|NCT00538057|Drug|GW685698X & GW642444M|study drug
16314835|NCT00538044|Drug|simvastatin|medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation
16314836|NCT00538031|Drug|cyclophosphamide|Given orally
16314837|NCT00538031|Drug|celecoxib|Given orally
16314838|NCT00538018|Drug|Telithromycin|
16314839|NCT00538005|Biological|bevacizumab|
16314840|NCT00538005|Drug|oxaliplatin|
16314841|NCT00538005|Drug|sorafenib tosylate|
16314842|NCT00537992|Procedure|combined surgery|UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure
16314843|NCT00537979|Drug|Paricalcitol injection|Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
16314844|NCT00537979|Drug|Paricalcitol capsules|Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
16314845|NCT00537966|Drug|Dolutegravir|In this arm patients with primary HIV-1 infection are treated with standard antiretroviral combination therapy (only drugs that have been approved by Swiss Medic)
16314846|NCT00537966|Drug|Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate|standard dosage
16314847|NCT00537966|Drug|Raltegravir|standard dosage
16314848|NCT00537966|Drug|Darunavir|standard dosage
16314849|NCT00537966|Drug|Ritonavir|used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
16314850|NCT00537966|Drug|Rilpivirine|standard dosage
16314851|NCT00537966|Drug|Lamivudine|standard dosage
16314852|NCT00537966|Drug|tenofovir|standard dosage
16314853|NCT00537966|Drug|Emtricitabine|standard dosage
16314854|NCT00537966|Drug|Abacavir|standard dosage
16314855|NCT00537953|Drug|Miltefosine , meglumine antimoniate|
16314856|NCT00537940|Drug|Pregabalin|150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
16314857|NCT00537940|Drug|Gabapentin|300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
16314858|NCT00537927|Procedure|laparoscopic correction of hernia with mesh|Correction of hernia with mesh and fixation of mesh using one of the arms.
16314859|NCT00537914|Drug|Somatropin|Infant, Small for Gestational Age, Omnitrope®/Somatropin, rhGH,
16314860|NCT00537901|Radiation|First-Line Bevacizumab and Chemotherapy|Chemotherapy
16314861|NCT00537901|Drug|Bevacizumab|Chemotherapy
16314862|NCT00537888|Drug|fluconazole|Intravenous or oral 400 md/d
16314863|NCT00537875|Dietary Supplement|Ginger|Capsule, 1000 mg, BID, 3 days
16314864|NCT00537875|Dietary Supplement|Placebo|Capsule, 1000 mg, BID, 3 days
16314865|NCT00537862|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16314866|NCT00537849|Device|Sonablate 500(SB-500)|
16314867|NCT00537836|Drug|BAY 86-5310 (ZK 283197)|3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks
16314868|NCT00537836|Drug|Placebo|Placebo, once daily p.o. over 8 weeks
16314869|NCT00537836|Drug|17ß-estradiol|1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks
16314870|NCT00537823|Drug|Cetuximab|
16314871|NCT00537823|Drug|Bevacizumab|
16314872|NCT00537823|Drug|Leucovorin|
16314873|NCT00537823|Drug|Oxaliplatin|
16314874|NCT00537823|Drug|Fluorouracil|
16314875|NCT00537810|Drug|Sibutramine|15 mg daily
16314876|NCT00537810|Drug|Placebo|Daily
16314877|NCT00537810|Behavioral|Self-help CBT + Sibutramine|Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
16314878|NCT00537810|Behavioral|Self-help CBT + Placebo|Cognitive behavioral treatment manual for binge eating Placebo daily
16314879|NCT00537797|Other|FDG-PET Scan|Positron emission tomography with 18F-fluorodeoxyglucose
16314880|NCT00537784|Biological|Autologous platelets|Local injection 10mL, about 2.5 x 10E10 platelets.
16314881|NCT00537784|Biological|no injection|
16314882|NCT00537771|Drug|Anastrozole|1 mg once daily oral dose
16314883|NCT00537771|Drug|Tamoxifen|20 mg once daily oral dose
16314884|NCT00537758|Behavioral|Cognitive Behavior Therapy|
16314888|NCT00537745|Other|Medication Management Therapy|Medication Management Therapy once a month.
16314889|NCT00537732|Drug|omeprazole|20 mg daily
16314890|NCT00537732|Drug|omeprazole|20 vs. 60 mg daily, genotype dependent
16314891|NCT00537719|Drug|GSK716155|albiglutide subcutaneous injection
16314892|NCT00537719|Drug|Placebo|placebo injection
16314893|NCT00537693|Procedure|Continuous Renal Replacement Therapy|Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.
16314894|NCT00537680|Drug|Idebenone|Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients > 45 kg/99 lbs: idebenone 900 mg/day
16314895|NCT00537680|Drug|Idebenone|Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day
16314896|NCT00537680|Drug|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
16314897|NCT00537667|Drug|anakinra|anakinra
16314898|NCT00537667|Drug|anakinra and PEG sTNF-R1|anakinra and PEG sTNF-R1
16314899|NCT00537654|Drug|Treatment sequence A|Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state
16314900|NCT00537654|Drug|Treatment sequence B|Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state
16314901|NCT00537654|Drug|Treatment sequence C|Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state
16314902|NCT00537654|Drug|Treatment sequence D|Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state
16314903|NCT00537615|Drug|PD 0332334|
16314904|NCT00537602|Drug|miglustat|
16314905|NCT00537602|Drug|placebo|
16314906|NCT00537589|Procedure|Ultrasound guided arthrocentesis|Guidance of joint aspiration by ultrasound guidance
16314907|NCT00537576|Biological|Low dose LACTIN-V applicator|Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days
16314908|NCT00537576|Biological|Medium dose LACTIN-V applicator|Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
16314909|NCT00537576|Biological|High dose LACTIN-V applicator|High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
16314910|NCT00537576|Other|Low dose Placebo applicator|Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
16314911|NCT00537576|Other|Medium dose Placebo|Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
16314912|NCT00537576|Other|High dose Placebo applicator|High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
16314913|NCT00537563|Drug|Telithromycin|
16314914|NCT00537550|Drug|Vincristine|Steroids pre-treatment
16314915|NCT00537550|Drug|Vincristin, Daunorubicine, Asparaginase, Methotrexate|Induction therapy
16314916|NCT00537537|Drug|Telbivudine|
16314917|NCT00537524|Biological|H5N1 Influenza Vaccine|Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
16314918|NCT00537524|Biological|H5N1 Influenza Vaccine|Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
16314919|NCT00537511|Drug|Pomalidomide|
16314920|NCT00537511|Drug|Cisplatin|
16314921|NCT00537511|Drug|Etoposide|
16314922|NCT00537498|Drug|Urokinase|"Daily intravenous application of urokinase over 30 minutes
~Dosage:
~If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l"
16314923|NCT00537485|Drug|SPM 962|transdermal application, 1 time per day
16314924|NCT00537485|Drug|placebo|transdermal application, 1 time per day
16314925|NCT00537472|Drug|Low dose bupivicaine in spinal anesthetic|Bupivacaine 9 mg intrathecal single shot injection at start of surgery
16314926|NCT00537472|Drug|Standard dose bupivacaine in spinal anesthetic|Bupivacaine 13 mg intrathecal single shot injection at start of surgery
16314927|NCT00537459|Drug|16448|
16314928|NCT00537446|Device|noninvasive positive pressure ventilation|Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
16314929|NCT00537446|Device|noninvasive positive pressure ventilation|Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
16314930|NCT00537433|Other|Pictogram|"The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication.
~Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home."
16314931|NCT00537420|Drug|Nasal Placebo|Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
16314932|NCT00537420|Drug|Placebo Capsule|Placebo capsules will be taken once daily with or without food.
16314933|NCT00537420|Drug|PYY3-36|Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
16314934|NCT00537420|Drug|PYY3-36|Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
16314935|NCT00537420|Drug|PYY3-36|Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
16314936|NCT00537420|Drug|Sibutramine|Sibutramine will be taken once daily with or without food
16314937|NCT00537407|Drug|Debio 025|Debio 025 supplied as a 100 mg/mL oral solution
16314938|NCT00537407|Drug|Peg-IFNα2a|Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes
16314939|NCT00537407|Drug|Ribavirin|Ribavirin supplied as 200 mg tablets
16314940|NCT00537394|Drug|Enfuvirtide|90mg subcutaneously twice daily
16314941|NCT00537394|Drug|Raltegravir|400 mg twice daily
16314942|NCT00537394|Drug|Darunavir|Two 300-mg tablets twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)
16314943|NCT00537394|Drug|Tipranavir|Two 250-mg capsules twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)
16314944|NCT00537394|Drug|Etravirine|Two 100-mg tablets twice daily
16314945|NCT00537394|Drug|Maraviroc|Dosage dependent on regimen in which maraviroc is included
16314946|NCT00537381|Drug|Docetaxel|Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
16314947|NCT00537381|Drug|Prednisone|Prednisone 5 mg orally twice daily.
16314948|NCT00537381|Biological|Intetumumab|Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
16314949|NCT00537381|Drug|Placebo|Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
16314950|NCT00537368|Drug|CNTO 888|
16314951|NCT00537355|Biological|Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate|6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
16314952|NCT00537355|Drug|Histamine|6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
16314953|NCT00537342|Biological|Immunotherapy with modified extract of O. europaea pollen|Sublingual (2 drops daily during 2 months)
16314954|NCT00537329|Drug|Anidulafungin|Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.
16314955|NCT00537316|Biological|Infliximab (IFX)|IFX intravenous (IV) infusion dosed at 5mg/kg of body weight
16314956|NCT00537316|Drug|Azathioprine (AZA)|AZA 50 mg tablet dosed at 2.5 mg/kg of body weight orally every day
16314957|NCT00537316|Drug|Placebo to Azathioprine|Placebo to AZA tablet orally every day
16314958|NCT00537316|Drug|Placebo infusion|Placebo to IFX intravenous (IV) infusion
16314959|NCT00537303|Drug|insulin detemir|Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
16314960|NCT00537303|Drug|insulin aspart|Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
16314961|NCT00537303|Drug|insulin aspart|Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
16314962|NCT00537290|Drug|Rituximab|Rituximab 1000mg IV on Days 0 and 15
16314963|NCT00537277|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
16314964|NCT00537264|Other|Health-related quality of life assessment|Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D. The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
16314965|NCT00537264|Other|Health-related quality of life assessment|Study participants will be asked to complete the following health-related quality of life questionnaires: EQ-5D, Health Utilities Index 3, SF-8 and SF-6D. The Singapore (Chinese) versions of these questionnaires have been previously tested and validated in a pilot cohort of the same study population.
16314966|NCT00537251|Drug|Insulin glargine|
16314967|NCT00537238|Drug|pregabalin|300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
16314968|NCT00537238|Drug|levetiracetam|1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
16314969|NCT00537225|Behavioral|exercise|tailored multifactor CVD risk reduction
16314970|NCT00537212|Other|The South Beach Diet|"Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of The South Beach Diet."
16314971|NCT00537212|Other|The Ornish Diet|"Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of The Ornish Diet book."
16314972|NCT00537212|Other|Control Group|This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.
16314973|NCT00537199|Other|Visual Examination|Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.
16314974|NCT00537199|Drug|OraTest|Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.
16314975|NCT00537186|Drug|Iron oligosaccharide|
16314976|NCT00537173|Procedure|Core Biopsy|biopsy
16314977|NCT00537173|Procedure|Blood Collection|Blood/serum sample
16314978|NCT00537173|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV, day 1, 8 and 15
16314979|NCT00537173|Drug|Avastin|Avastin 10 mg/kg IV, day 1 and 15
16314980|NCT00537160|Behavioral|Behavior modification, Nutrition Education, Exercise|
16314981|NCT00537147|Biological|WN/DEN4delta30 vaccine|Live attenuated WN/DEN4delta30 vaccine (one of two doses)
16314982|NCT00537147|Biological|Placebo|Placebo for WN/DEN4delta30 vaccine
16314983|NCT00537134|Device|Embolization, coiling|Endovascular embolization with platinum coils
16314984|NCT00537121|Drug|fluorouracil|Given IV
16314985|NCT00537121|Drug|irinotecan hydrochloride|Given IV
16314986|NCT00537121|Drug|leucovorin calcium|Given IV
16314987|NCT00537121|Drug|vorinostat|Taken Orally
16314988|NCT00537121|Other|pharmacological study|Correlative Study
16315047|NCT00536861|Drug|erlotinib|"Level 1 : erlotinib 100 mg/day from day -7 to the time of completion of 10 fractions of cranial irradiation, followed by 150 mg/day until disease progression or toxicity
~Level 2 : erlotinib 150 mg/day from day -7 before cranial irradiation, followed by 150 mg/day until disease progression or toxicity"
16315048|NCT00536848|Dietary Supplement|Lactobacillus rhamnosus GR-1 + Lactobacillus reuteri RC-14|
16315049|NCT00536848|Dietary Supplement|Placebo|
16315050|NCT00536848|Drug|Metronidazole|
16315290|NCT00535119|Drug|Paclitaxel|Given IV
16315291|NCT00535119|Other|Pharmacological Study|Correlative studies
16314989|NCT00537108|Behavioral|Home visiting and care management|Third trimester teens are assigned a Care Manager (CM) who establishes a continuity relationship and provides monthly visits until the index child is 2 years old. Core services for intervention group include: 1)Baseline and ongoing assessment of health, mental health, housing, daycare, and school needs; 2)Administration of a culturally sensitive, developmentally relevant parenting curriculum; 3)Computer Assisted Motivational Interviewing to promote healthy relationships, improve contraceptive practices, focus on goals, and promote school continuation; 4)Efforts to engage the young father; 5)Linkage and coordination with primary care for teen, child, young father; 6)Support & skills-building for school continuation, higher education, and job readiness.
16314990|NCT00537095|Drug|Vandetanib|300 mg oral once daily oral dose
16314991|NCT00537095|Other|Placebo|
16314992|NCT00537082|Drug|FTY720|Administered orally once daily for 6 months
16314993|NCT00537082|Drug|Placebo|Administered orally once daily for 6 months
16314994|NCT00537056|Procedure|FDG PET CT|nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
16314995|NCT00537056|Procedure|DCE MRI|DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
16314996|NCT00537056|Drug|F-18 Fluoro-deoxi-glucose|15 mCi iv
16314997|NCT00537056|Drug|Gadolinium-DTPA|0.1 mmol/kg iv
16314998|NCT00537056|Drug|Sunitinib|50 mg/day po
16314999|NCT00537043|Drug|SK&F-105517 (COREG CR FDC)|
16315000|NCT00537030|Drug|Asparaginase|Given IM
16315001|NCT00537030|Other|Laboratory Biomarker Analysis|Correlative studies
16315002|NCT00537030|Other|Pharmacological Study|Correlative studies
16315003|NCT00537017|Drug|Preladenant|5 mg BID capsules
16315004|NCT00537017|Drug|L-dopa|Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
16315005|NCT00537017|Drug|Other Parkinson's Disease treatments|Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.
16315006|NCT00536991|Dietary Supplement|Calcitriol|Given PO
16315007|NCT00536991|Drug|Ketoconazole|Given PO
16315008|NCT00536991|Other|Laboratory Biomarker Analysis|Correlative studies
16315009|NCT00536991|Other|Pharmacological Study|Correlative studies
16315010|NCT00536991|Drug|Therapeutic Hydrocortisone|Given PO
16315011|NCT00536978|Drug|ARA-C|100 mg/m^2 IV Daily Over 1 Hour for 4 Days
16315012|NCT00536978|Drug|BCNU|300 mg/m^2 IV Over 1 Hour for 1 Day
16315013|NCT00536978|Drug|Campath-1H|15 mg IV Daily Over 30 Minutes for 3 Days
16315014|NCT00536978|Drug|Cyclophosphamide|1000 mg/m^2 IV Daily Over 1 Hour for 3 Days
16315015|NCT00536978|Drug|Etoposide|100 mg/m^2 IV Daily Over 3 Hours for 4 Days
16315016|NCT00536978|Drug|Fludarabine|30 mg/m^2 IV Daily Over 1 Hour for 3 Days
16315017|NCT00536978|Drug|Melphalan|100 mg/m^2 IV Over 30 Minutes for 1 Day.
16315018|NCT00536978|Drug|Rituximab|375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks.
16315019|NCT00536978|Other|Allogeneic Stem Cell Transplantation|Stem Cell Infusion on Day 0.
16315020|NCT00536978|Radiation|Total body radiation (TBI)|TBI on Day 5 following chemotherapy, before stem cell infusion.
16315021|NCT00536978|Drug|Methotrexate|5 mg/m2 IV on Days +1, +3, and +6.
16315022|NCT00536978|Drug|Tacrolimus|0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.
16315023|NCT00536978|Procedure|Adback NK or T Cell|Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.
16315024|NCT00536952|Drug|Pulmozyme|Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
16315025|NCT00536952|Drug|Placebo|Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
16315026|NCT00536952|Radiation|Radiation Therapy|5 days per week for 4 weeks
16315027|NCT00536939|Drug|Enzastaurin|1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
16315028|NCT00536939|Drug|Bevacizumab|10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
16315029|NCT00536939|Drug|Paclitaxel|90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
16315030|NCT00536939|Drug|Placebo|Oral, daily, until disease progression
16315031|NCT00536926|Device|Home spirometry with data transfer via cell phone|home spirometry recording
16315032|NCT00536926|Device|Home spirometer with BT-cellphone|Data transfer of home spirometry recordings via bluetooth to clinical database.
16315033|NCT00536926|Device|Home spirometer w/o BT|Standard home spirometry
16315034|NCT00536913|Drug|Budesonide/formoterol pMDI 40/2.25ug + spacer|
16315035|NCT00536913|Drug|Budesonide/formoterol pMDI 40/2.25 ug|
16315036|NCT00536900|Behavioral|Advisor-Teller Money Manager|The acronym for the functions of ATM are TTT-- Teller (storing patient funds), Training patients by making and reviewing monthly budgets, and Treatment-Linked Spending in which weekly behavioral contracts link disbursement to completion of abstinence-related activities
16315037|NCT00536900|Behavioral|FIT|FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
16315038|NCT00536887|Drug|atorvastatin|atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
16315039|NCT00536874|Drug|gemcitabine hydrochloride|1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles
16315040|NCT00536874|Drug|oxaliplatin|80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.
16315041|NCT00536874|Genetic|protein expression analysis|
16315042|NCT00536874|Genetic|proteomic profiling|
16315043|NCT00536874|Other|diagnostic laboratory biomarker analysis|
16315044|NCT00536874|Procedure|adjuvant therapy|
16315045|NCT00536874|Procedure|neoadjuvant therapy|
16315046|NCT00536874|Procedure|therapeutic conventional surgery|
16315051|NCT00536835|Drug|GSK461364|GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.
16315052|NCT00536809|Drug|lapatinib|onced daily Days 1-21
16315053|NCT00536809|Drug|oxaliplatin|Day one of each cycle
16315054|NCT00536809|Drug|capecitabine|given BID days 1-14
16315055|NCT00536783|Drug|Quetiapine|
16315056|NCT00536770|Drug|placebo + gemcitabine + erlotinib|
16315057|NCT00536770|Drug|Placebo + gemcitabine|
16315058|NCT00536770|Drug|calcitriol + gemcitabine|
16315059|NCT00536770|Drug|calcitriol + gemcitabine + erlotinib|
16315060|NCT00536744|Device|acoustical pulse energy (extracorporeal shockwave)|Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.
16315061|NCT00536744|Other|Sham|Non-energized (inactive - Sham) application + standard of care
16315062|NCT00536731|Drug|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
16315063|NCT00536731|Drug|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
16315064|NCT00536731|Drug|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
16315065|NCT00536718|Genetic|gene expression analysis|
16315066|NCT00536718|Genetic|molecular diagnostic method|
16315067|NCT00536718|Genetic|polymorphism analysis|
16315068|NCT00536718|Genetic|protein expression analysis|
16315069|NCT00536718|Other|medical chart review|
16315070|NCT00536718|Other|questionnaire administration|
16315071|NCT00536705|Drug|montelukast|montelukast 5-mg chewable tablet with matching placebo once daily in the evening at bedtime.The study consisted of a 2-week, single-blind placebo baseline period and a 12-week double-blind, active treatment period
16315072|NCT00536692|Drug|mecamylamine|topical ocular drops
16315073|NCT00536679|Drug|GSK163090 capsule, fasted|GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water.
16315074|NCT00536679|Drug|GSK163090 Tablet, fasted|GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water.
16315075|NCT00536679|Drug|GSK163090 Tablet, fed|GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast.
16315076|NCT00536666|Drug|Iron oligosaccharide|
16315077|NCT00536653|Drug|Bicalutamide and Calcium/ Vitamin D supplementation|Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
16315078|NCT00536653|Drug|LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation|3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily
16315079|NCT00536653|Drug|LHRH agonists (Goserelin acetate)|3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
16315080|NCT00536640|Drug|Erlotinib|150 mg per os, given daily until tumor progression
16315081|NCT00536640|Drug|Bevacizumab|15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
16315082|NCT00536640|Drug|Gemcitabine|1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
16315083|NCT00536640|Drug|Cisplatin|80 mg/m2 i.v. on day 1 (three-week cycle) until tumor progression for a maximum of 6 cycles. (The administration of 40 mg/2 Cisplatin on day 1 and day 8 is also possible)
16315084|NCT00536627|Biological|DNA vaccine pCMVS2.S|Patients will receive injections of 1 ml of vaccine (1 mg/ml) at weeks 0, 8, 16, 40 and 44
16315085|NCT00536614|Genetic|cetuximab|Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.
16315086|NCT00536601|Drug|etoposide|Given IV
16315087|NCT00536601|Drug|cyclophosphamide|Given IV
16315088|NCT00536601|Drug|carmustine|Given IV
16315089|NCT00536601|Drug|melphalan|Given IV
16315090|NCT00536601|Drug|busulfan|Given IV
16315091|NCT00536601|Drug|carboplatin|Given IV
16315092|NCT00536601|Drug|thiotepa|Given IV
16315093|NCT00536601|Radiation|total-body irradiation|Undergo TBI
16315094|NCT00536601|Procedure|autologous hematopoietic stem cell transplantation|Undergo ASCT
16315095|NCT00536601|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Undergo tandem ASCT
16315096|NCT00536588|Genetic|SCH 721015 with SCH 209702|Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10^9 to 3 x 10^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).
16315097|NCT00536575|Drug|Bortezomib|"Dose Level 1: Bortezomib 1.3mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
~Dose Level 2: Bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
~Dose Level 3: Bortezomib 1.6mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle."
16315098|NCT00536575|Drug|Sorafenib|"Dose Levels 1 and 2: 200 mg by mouth twice daily
~Dose Level 3: 400 mg by mouth twice daily"
16315099|NCT00536562|Behavioral|Comprehensive Cardiac Rehabilitation (CR)|6-month Comprehensive Cardiac Rehabilitation program consisting of: 1) initial medical assessment by case manager and physician to determine CR strategies; 2) entry exercise stress test; 3) multi-disciplinary assessment and intervention to achieve risk factor targets in nutrition & psychological services as needed; 4) twice per week supervised exercise training and twice per week home-based exercise following an individualized, progressive prescription; 5) Exit assessment at 6 months.
16315100|NCT00536549|Device|Guardian RT|
16315101|NCT00536549|Behavioral|Education about the self monitoring blood glucose|
16315102|NCT00536536|Behavioral|Obesity management framework|Treatment in primary care will be compared to treatment in a secondary hospital setting. Treatment in both cases will be provided by a multi-disciplinary team of: obesity or practice nurse, dietitian, exercise specialist with some input from medical team.
16315147|NCT00536172|Drug|Placebo|Placebo distribution matches the active medication.
16315292|NCT00535119|Drug|Veliparib|Given PO
16315103|NCT00536510|Drug|laropiprant/niacin (MK0524A)|"Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks
~Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks.
~All patients will receive placebo for a 4 week run-in period before randomization"
16315104|NCT00536510|Drug|Comparator: placebo|"Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks
~Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks.
~All patients will receive placebo for a 4 week run-in period before randomization."
16315105|NCT00536497|Drug|GW842166X|
16315106|NCT00536484|Drug|Fesoterodine|4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
16315107|NCT00536484|Drug|Placebo|Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
16315108|NCT00536471|Drug|Duloxetine hydrochloride|
16315109|NCT00536471|Drug|Placebo|
16315110|NCT00536458|Procedure|radiotherapy|mini chep+ radiotherapy
16315111|NCT00536458|Drug|MINI CHEP|chemotherapy minichep 6 courses
16315112|NCT00536445|Device|NAVA|Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
16315113|NCT00536419|Drug|Methylphenidate|Methylphenidate SODAS 0.3 mg/kg/day (day 1); 0.7 mg/kg/day (day 2); 1.0 mg/kg/day (days 3 and 4)
16315114|NCT00536419|Other|Placebo|Placebo, daily dose, 4 days, oral administration
16315115|NCT00536406|Behavioral|BE-ACTIV|BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
16315116|NCT00536406|Behavioral|Treatment as usual (TAU)|TAU includes usual treatment in nursing care facility.
16315117|NCT00536393|Drug|Doxorubicin|
16315118|NCT00536393|Drug|Doxorubicin pegylated|
16315119|NCT00536380|Drug|5-mg Desloratadine|5-mg desloratadine tablets, once daily for four weeks.
16315120|NCT00536380|Drug|10-mg Desloratadine|10-mg desloratadine tablets, once daily for four weeks.
16315121|NCT00536380|Drug|20-mg Desloratadine|20-mg desloratadine tablets, once daily for four weeks.
16315122|NCT00536367|Other|No intervention - observational study only|
16315123|NCT00536354|Other|Postural Orientation|
16315124|NCT00536341|Drug|lenalidomide|2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6
16315125|NCT00536341|Drug|Rituximab|375 mg/m2 Cycle 1 (split over Day 1 & Day 2); 500 mg/m2 Day 1 of Cycles 2-6
16315126|NCT00536341|Drug|Fludarabine|25 mg/m2 on Days 1, 2, and 3
16315127|NCT00536302|Dietary Supplement|Collagen Hydrolysate|Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
16315128|NCT00536302|Dietary Supplement|Placebo|Matching placebo solution per day by mouth for 48 weeks.
16315129|NCT00536289|Device|Blunt needle|Blunt tipped suture needle
16315130|NCT00536276|Dietary Supplement|Vitamin D2|Daily enteral dose of 100IU/kg
16315131|NCT00536276|Dietary Supplement|Vitamin D3|Daily enteral dose of 100IU/kg
16315132|NCT00536263|Drug|pegylated interferon alpha-2b|1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
16315133|NCT00536263|Drug|pegylated interferon alpha-2b|1.5 mcg/kg S.C. QW for 24 weeks
16315134|NCT00536263|Drug|pegylated interferon alpha-2b|1.5 mcg/kg S.C. QW for 48 weeks
16315135|NCT00536237|Drug|Comparator: niacin / Duration of Treatment: 17 Weeks|
16315136|NCT00536237|Drug|MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks|
16315137|NCT00536237|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks|
16315138|NCT00536224|Behavioral|Full counseling|"The health educator generated a computerized report for the patient that outlined his/her Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal. Based on the Ask-Advise-Assess-Assist-Arrange follow-up (5A's) framework for behavior change, counseling for specific risk-related behaviors (diet, physical activity, and smoking) was provided by a cardiovascular rehabilitation health educator in the emergency department and during telephone follow-up (2 sessions over 6 weeks). Patients also received a general informational handout on self-management of cardiovascular risk factors (AHA Brochure Controlling your risk factors). A full report was also be sent to the patient's primary care physician (if any) at the conclusion of counseling."
16315139|NCT00536224|Behavioral|Minimal counseling|"Patients assigned to the minimal counseling intervention received brief counseling (<5 minutes) on the benefits of changing lifestyle and a handout with general information on self-management of cardiovascular risk factors.
~Patients assigned to minimal intervention also received an AHA brochure (Controlling your risk factors) with general information on management of cardiovascular risk factors. At the end of 6-month follow-up, patients received a computerized report that outlined their Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal."
16315140|NCT00536211|Behavioral|Exercise|Exercise training will consist of walking and/or jogging on a treadmill 5 out of 7 d each week at ~60% of each subject's predetermined VO2max (75% maximal heart rate as monitored by heart rate monitors), 45 min/session, for 12 weeks. The exercise training will follow a three-stage progression: 1. wk 1 = 30 min, 3 d/wk, 60% VO2max; 2. wk 2 = 30 min, 5 d/wk, 60% VO2max; and 3. wk 3-12 = 45 min, 5 d/wk, 60% VO2max.
16315141|NCT00536211|Drug|Metformin|oral tablet, 1000 mg daily for 17 days
16315142|NCT00536198|Drug|Sertraline|50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
16315143|NCT00536198|Drug|Placebo|50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
16315144|NCT00536185|Dietary Supplement|Fish Oil|capsules, 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA), 6 weeks
16315145|NCT00536185|Dietary Supplement|Placebo|capsule, 5.0 g/d corn/soybean oil (50/50 mixture), 6 weeks
16315146|NCT00536172|Drug|Escitalopram|Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
16315148|NCT00536159|Other|Medicaid Maternal and Infant Support Services|Enhanced services include home visiting, transportation, psychosocial counseling, multidisciplinary planning, case management, nutritional guidance, and pregnancy and parenting education during pregnancy and infancy. The services are delivered primarily by nurses with occasional visits by social workers or nutritionists. In the county of the study (Kent), women who were assessed were provided intervention services.
16315149|NCT00536159|Other|Nurse-CHW team|A nurse and two CHWs functioned as a team, using visit and clinical guidelines that detailed expected care. Each team provided services for approximately 50-60 families. While occasional visits were made by both providers, most visits were made by either provider alone. Nurses guided the CHW care, led a multidisciplinary team assessment (with social workers, nutritionists, and others), provided crisis intervention and case management, assessed and managed health problems (including screening for depression and mental health care), and had periodic office visits with prenatal providers. CHWs provided relationship-based support by attempting weekly prenatal contact that alternated phone and face-to-face visits and used peer role modeling and personal empowerment approaches.
16315150|NCT00536133|Drug|Zinc|5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
16315151|NCT00536133|Other|placebo|5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
16315152|NCT00536120|Biological|BG00002 (natalizumab)|
16315153|NCT00536120|Biological|keyhole limpet hemocyanin (KLH)|KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.
16315154|NCT00536120|Biological|tetanus diphtheria toxoid vaccine (Td)|Td administered in accordance with the manufacturer's prescribing information.
16315155|NCT00536107|Drug|Gefitinib|250 mg oral
16315156|NCT00536107|Procedure|CT or MRI|performed at screening and every 6 weeks
16315157|NCT00536107|Drug|Docetaxel|60mg/m2 intravenous infusion
16315158|NCT00536094|Behavioral|Cognitive behavioral therapy (CBT)|CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
16315159|NCT00536094|Behavioral|Treatment as usual (TAU)|TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
16315160|NCT00536081|Drug|pegfilgrastim|6 mg s.c. 24-36 h post-chemotherapy
16315161|NCT00536068|Drug|Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo|"Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days
~Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days
~Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days
~Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days"
16315162|NCT00536042|Drug|Minocycline|addition of 150 mg to 250 mg po bid to standard asthma care regiment
16315163|NCT00536016|Drug|JSM6427|Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml.
16315164|NCT00536003|Drug|progesterone|vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
16315165|NCT00536003|Drug|placebo|vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
16315166|NCT00535977|Dietary Supplement|Broccoli|400g ITC-enriched broccoli per week for 12 months
16315167|NCT00535977|Dietary Supplement|Peas|400g frozen garden peas per week for 12 months
16315168|NCT00535951|Drug|LBH589|
16315169|NCT00535938|Other|botulinum toxin type A|There will be no protocol-mandated intervention with regard to physician treatment choice or management of patient condition once the patient is enrolled in the project.
16315170|NCT00535925|Drug|SoC therapy|the patients have to be treated according the standard good medical practice by any center
16315171|NCT00535925|Drug|irbesartan|"Therapy for hypertension:
~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"
16315172|NCT00535925|Drug|ramipril|"Therapy for hypertension:
~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"
16315173|NCT00535925|Drug|hydrochlorothiazide|"Therapy for hypertension
~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"
16315174|NCT00535925|Drug|furosemide|"Therapy for hypertension
~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"
16315175|NCT00535925|Drug|amlodipine|"Therapy for hypertension
~- Step 3: amlodipine up to 10 mg/die"
16315176|NCT00535925|Drug|atenolol|"Therapy for hypertension
~- Step 4: atenolol up to 100 mg/die"
16315177|NCT00535925|Drug|doxazosin|"Therapy for hypertension
~- Step 5: doxazosin up to 4 mg/die"
16315178|NCT00535925|Drug|clonidine|"Therapy for hypertension
~- Step 6: clonidine"
16315179|NCT00535925|Drug|insulin|"Therapy for Hyperglycaemia (to achieve HbA1c <7):
~- insulin"
16315180|NCT00535925|Drug|simvastatin|"Therapy for hypercholesterolemia:
~- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die"
16315181|NCT00535925|Drug|fibrate|"Therapy for hypertriglyceridemia
~- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate"
16315182|NCT00535925|Drug|erythropoietin|"Treatment of anaemia:
~- erythropoietin"
16315183|NCT00535925|Drug|aspirin|"Antiplatelet therapy (in all patients without contraindications):
~- aspirin up to 160 mg/die"
16315184|NCT00535912|Procedure|Stem cells autograft|Treatment by Intensive Chemotherapy and autograft
16315185|NCT00535886|Dietary Supplement|Man-made Trans FA|EA as 6% of total energy
16315186|NCT00535886|Dietary Supplement|Natural Trans FA|VA as 6% of total energy
16315187|NCT00535886|Dietary Supplement|Oleic Acid|OA as 6% of total energy
16315188|NCT00535873|Drug|Lenalidomide|Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
16315189|NCT00535860|Drug|Teriparatide|Daily for 96 days
16315190|NCT00535847|Drug|Telaprevir|Tablet
16315191|NCT00535847|Drug|Ribavirin|Tablet
16315192|NCT00535847|Drug|Pegylated interferon alfa 2a|Solution for Injection
16315193|NCT00535834|Procedure|diagnostic procedure|
16315194|NCT00535834|Procedure|molecular diagnostic method|
16315195|NCT00535834|Procedure|protein expression analysis|
16315196|NCT00535821|Device|Esophageal Doppler monitoring - CardioQ, Deltex Inc|6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM
16315197|NCT00535821|Device|Central line with CVP and continuous ScvO2 monitoring|6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring
16315198|NCT00535808|Drug|nitroprusside|Administration of nitroprusside
16315199|NCT00535808|Drug|nitroglycerine|Administration of nitroglycerine
16315200|NCT00535808|Drug|sevoflurane|Administration of Sevoflurane
16315201|NCT00535795|Radiation|Radiation Therapy|Radiation Therapy
16315202|NCT00535782|Drug|Tocilizumab|Administered by intravenous infusion, 8 mg/kg every 4 weeks.
16315203|NCT00535782|Drug|Placebo|Placebo to tocilizumab administered by intravenous infusion every 4 weeks.
16315204|NCT00535782|Drug|Methotrexate|Administered orally or parenterally, 7.5-25 mg weekly.
16315205|NCT00535769|Device|Electronic + no text message|Electronic monitor is attached but no text-messages are sent through cellular phones
16315206|NCT00535769|Device|Electronic monitor + text messages|Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
16315207|NCT00535756|Drug|Creon|3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
16315208|NCT00535756|Drug|Placebo|Placebo
16315209|NCT00535743|Drug|Sugammadex|Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
16315210|NCT00535743|Drug|Placebo|0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
16315211|NCT00535743|Drug|Esmeron®|Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
16315212|NCT00535730|Biological|Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™|0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
16315213|NCT00535730|Biological|Comparator: placebo (concomitant-vaccine matched)|Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
16315214|NCT00535730|Biological|Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23|Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
16315215|NCT00535717|Procedure|uttarbasti (per urethral administration of medicated oil )|
16315216|NCT00535704|Behavioral|Strong African American Families-Teen Program|5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.
16315217|NCT00535704|Behavioral|FUEL|5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours
16315218|NCT00535691|Drug|Tacrolimus Ointment 0.03%|Twice daily, 14 days treatment.
16315219|NCT00535691|Drug|Tacrolimus Ointment 0.03%|Once daily, 14 days treatment.
16315220|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 14 days apart: 5 microgram per dose
16315221|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 5 microgram per dose
16315222|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 10 microgram per dose
16315223|NCT00535665|Biological|pandemic influenza vaccine (H5N1 strain NIBRG-14)|two-dose regimen with 28 days apart: 15 microgram per dose
16315224|NCT00535652|Drug|Ertapenem|powder for infusion, 1 gram I.V., single dose over 30 min.
16315225|NCT00535639|Drug|Betula Verrucosa allergen extract|
16315226|NCT00535626|Device|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell
16315227|NCT00535613|Drug|Propofol|IV, single bolus at completion of anesthetic, 0.1 ml/kg
16315228|NCT00535587|Behavioral|Exercise|
16315229|NCT00535587|Drug|pyridostigmine|
16315230|NCT00535587|Drug|Placibo|
16315231|NCT00535587|Behavioral|Attention Control|
16315232|NCT00535574|Drug|Bexarotene (Targretin LGD1069)|75 mg per day for 6 weeks
16315233|NCT00535574|Drug|bexarotene|75 mg/day 6 weeks
16315234|NCT00535561|Drug|Ferrous sulfate tablets 325 mg, po, TID|
16315235|NCT00535561|Drug|Ferrous sulfate plus levothyroxine|Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
16315236|NCT00535548|Biological|Stem cell therapy|Injection of a hematopoietic stem cell suspension (50'000 CD 34+ cells per microliter) into the wound (1 microliter per cm2 of wound surface)
16315237|NCT00535535|Dietary Supplement|Fructose|Fructose, 0.5 g/kg
16315238|NCT00535535|Dietary Supplement|Fructose and Glucose|Fructose:Glucose 1:1, 1 g/kg
16315239|NCT00535535|Dietary Supplement|Fructose and Glucose|Fructose:Glucose 1:1, 2g/kg
16315240|NCT00535522|Drug|TAK-285 Dose Escalation Cohorts|TAK-285 50 mg tablet, orally, once or twice daily for three weeks, followed by seven days off. Dose escalation to maximum tolerated dose, with possibility of continuous dosing per cycle (daily dosing for four weeks without a break between cycles).
16315241|NCT00535522|Drug|TAK-285 Recommended Phase 2 Dosing Cohort|Expanded cohort with dose and regimen dependent upon the safety profile of the maximally tolerated dose and schedule determined in the dose escalation phase of the study.
16315242|NCT00535509|Radiation|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
16315243|NCT00535509|Other|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
16315244|NCT00535509|Drug|Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT
16315245|NCT00535496|Drug|sugammadex|Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.
16315246|NCT00535470|Drug|0.04% Mechlorethamine gel|Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.
16315247|NCT00535457|Other|Preoperative Magic Tricks|"Watching magic; Study patients will watch the anesthesiologist performing tricks (magic) before anesthesia induction."
16315248|NCT00535444|Other|Parish nurse visit|One visit with the parish nurse in 2 weeks
16315249|NCT00535431|Drug|AER 001|60 mg (in nebuliser), twice daily for 28 days
16315250|NCT00535431|Drug|placebo|Sterile saline nebulised, twice daily for 28 days
16315251|NCT00535418|Drug|Letrozole|
16315252|NCT00535405|Drug|Atorvastatin 10 mg|Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
16315253|NCT00535405|Drug|Ezetimibe 10 mg/simvastatin 20 mg|Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
16315254|NCT00535405|Drug|Atorvastatin 20 mg|Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
16315255|NCT00535405|Drug|Ezetimibe 10 mg/simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
16315256|NCT00535405|Drug|Atorvastatin 40 mg|Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
16315257|NCT00535392|Drug|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
16315258|NCT00535379|Drug|Sunitinib|Patients will receive SUTENT 37.5mg (3 x 12.5mg capsules) PO daily in the morning after breakfast. After 2 weeks without treatment-related adverse events grade ≥ 2 (ECOG common toxicity criteria: refer to Protocol Attachment A.4) a SUTENT dose escalation to 50mg (4 x 12.5mg capsules) PO daily has to be performed. Treatment will continue until patients develop progression of disease or until unacceptable adverse events occur.
16315259|NCT00535366|Drug|Tiotropium|Oral inhalation by HandiHaler® device
16315260|NCT00535366|Drug|Salmeterol|Oral inhalation from Diskus®
16315261|NCT00535366|Drug|Fluticasone|Oral inhalation from metered dose inhaler (MDI)
16315262|NCT00535366|Drug|Ciclesonide low|Oral inhalation from MDI
16315263|NCT00535366|Drug|Ciclesonide high|Oral inhalation from MDI
16315264|NCT00535366|Drug|Placebo|Oral inhalation from MDI
16315265|NCT00535353|Drug|irinotecan hydrochloride|In Part A, a continuous oral AZD2281 dose will be given in combination with irinotecan given as a 90 minute infusion on day 1 every 21 days. In Part B, AZD2281 will be given on days 1-5 and irinotecan as a 90 minute infusion on day 3 each cycle. Cycles are repeated every 14 days.
16315266|NCT00535353|Drug|olaparib|In Part A, a continuous oral AZD2281 dose will be given in combination with irinotecan given as a 90 minute infusion on day 1 every 21 days. In Part B, AZD2281 will be given on days 1-5 and irinotecan as a 90 minute infusion on day 3 each cycle. Cycles are repeated every 14 days.
16315267|NCT00535340|Drug|SR58611A|
16315268|NCT00535314|Drug|RTA 402 Dose1|
16315269|NCT00535314|Drug|RTA 402 Dose2|
16315270|NCT00535301|Device|grafted anterior prolapse repair|anterior vaginal prolapse repair with graft
16315271|NCT00535301|Procedure|sutured anterior vaginal prolapse repair|anterior vaginal prolapse repair with suture
16315272|NCT00535288|Drug|Esmirtazapine|Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
16315273|NCT00535288|Drug|Placebo|Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
16315274|NCT00535275|Drug|Chemotherapy with platine|Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
16315275|NCT00535275|Drug|Chemotherapy without Cisplatine|Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
16315276|NCT00535262|Drug|EmSam|Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
16315277|NCT00535236|Biological|V212|0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
16315278|NCT00535236|Biological|Placebo|0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
16315279|NCT00535223|Behavioral|Group Based Exposure Therapy|GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
16315280|NCT00535223|Behavioral|Present Centered Group Therapy|"Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
16315281|NCT00535210|Behavioral|Cardiovascular training|The cardiovascular training group will receive their usual therapy plus 3 days of 30 minutes of exercise per week. This program will last for 6 weeks while the participant is in the hospital. The cardiovascular training program will include pushing and pulling on pulleys, wheeling over mats, punching a boxing bag, and using an arm ergometer. The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital.
16315282|NCT00535210|Behavioral|Balance training|The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital. The balance training program will include sitting on mats - moving arm support from in front of the body to behind body, moving from sitting to lying and back up, and catching soft foam ball thrown directly to centre of chest and throwing it back.
16315283|NCT00535197|Biological|Infusion of autologous CD34+ stem cells into middle cerebral artery|intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
16315284|NCT00535158|Drug|Ergocalciferol (Vitamin D 2)|50,000units once weekly for 8 weeks then every other week for 4 weeks
16315285|NCT00535145|Drug|Treatment as usual (TAU), Paliperidone ER|Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
16315286|NCT00535132|Drug|Oral Risperidone|4 or 6 mg MG once daily for 0-2 weeks
16315287|NCT00535132|Drug|Paliperidone ER|6, 9 or 12 MG once daily for 4-6 weeks
16315288|NCT00535119|Drug|Carboplatin|Given IV
16315293|NCT00535106|Device|Automated external defibrillator (Philips FR2+ AED)|Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts.
16315294|NCT00535106|Device|SmartCPR|Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient.
16315295|NCT00535106|Other|Delayed defibrillation|In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.
16315296|NCT00535093|Device|rapid streptococcal testing|Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture
16315297|NCT00535080|Drug|Metvix (methyl aminolevulinate)|Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm².
16315298|NCT00535067|Behavioral|Questionnaire|Questionnaires taking 60 minutes total to complete.
16315299|NCT00535054|Drug|Tears Again|Liposome Eye Spray
16315300|NCT00535041|Drug|Chemotherapy, radiation therapy & surgery|radiation and chemotherapy
16315301|NCT00535028|Drug|AER 001|AER 001 25 mgs s.c. once daily for 28 days
16315302|NCT00535028|Drug|placebo|sterile saline
16315303|NCT00535015|Drug|Betamarc|2 tabs BID
16315304|NCT00535002|Drug|Yohimbine|Participants were pre-treated with either yohimbine or placebo.
16315305|NCT00535002|Drug|Placebo|
16315306|NCT00534989|Procedure|FDG PET|FDG PET
16315307|NCT00534976|Drug|Comparator: montelukast sodium|"Patients 4-5 years: 4 mg Montelukast chewable tablet daily
~Patients 6-14 years: 5 mg chewable tablet daily"
16315308|NCT00534976|Drug|Comparator: Comparator: placebo (unspecified)|"Patients 4-5 years: 4 mg Pbo chewable tablet daily
~Patients 6-14 years: 5 mg Pbo chewable tablet daily"
16315309|NCT00534963|Procedure|cervical vs. uterine placement of balloon catheter|
16315310|NCT00534950|Radiation|5 vs 6 weekly fraction of RT|Chemotherapy
16315311|NCT00534937|Procedure|Compression wrapping|Short-stretch compression wrap will be applied at least once a week.
16315312|NCT00534937|Procedure|Flexitouch compression pump|In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.
16315313|NCT00534924|Drug|Vit C|
16315314|NCT00534924|Procedure|Postconditioning|
16315315|NCT00534924|Other|no intervention|
16315316|NCT00534911|Behavioral|Cognitive Behavioral Therapy|"Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
~Other Name: Primary and secondary coping enhancement training (PASCET)"
16315317|NCT00534911|Behavioral|Supportive Non-directive Therapy (SNDT)|SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
16315318|NCT00534898|Drug|Bexarotene|
16315319|NCT00534898|Drug|Fenretinide|
16315320|NCT00534898|Drug|Placebo|
16315321|NCT00534885|Biological|Healive® Lot 1|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
16315322|NCT00534885|Biological|Healive® Lot 2|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
16315323|NCT00534885|Biological|Healive® Lot 3|Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart
16315324|NCT00534885|Biological|Havrix|Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
16315325|NCT00534872|Drug|SB-649868|10 mg
16315326|NCT00534859|Device|High Risk PCI|High Risk Percutaneous Coronary Intervention
16315327|NCT00534846|Drug|toremifene|The medication is given in tablet form, and the participants are instructed to take one tablet daily from cycle day 15 until the next menstruation. The active (toremifene 20 mg) and control (placebo) tablets were identical in appearance.
16315328|NCT00534846|Drug|placebo|tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
16315329|NCT00534833|Biological|DTaP-HB-PRP~T vaccine|0.5 mL, Intramuscular
16315330|NCT00534833|Biological|Tritanrix-HepB/Hib™|0.5 mL, Intramuscular
16315331|NCT00534833|Biological|Oral Polio Vaccine|0.5 mL, Oral
16315332|NCT00534820|Procedure|Cytogenetic Analysis of Bone Marrow Specimen|Cytogenetic Analysis of BM Specimen
16315333|NCT00534807|Drug|Vinflunine|
16315334|NCT00534807|Drug|Rifampin|
16315335|NCT00534794|Drug|Elestat|Elestat BID for 2 days
16315336|NCT00534794|Drug|Pataday|Pataday QD for 2 days
16315337|NCT00534781|Device|plasma microdebrider|Coblation of the Achilles
16315338|NCT00534781|Procedure|Mechanical Surgical Debridement|Surgical Debridement of the Achilles
16315339|NCT00534768|Procedure|active debridement|debridement on 1st, 3-5th and 7th postoperative days
16315340|NCT00534768|Procedure|control group|Postoperative debridement on 7th postoperative day
16315341|NCT00534755|Other|Breast Cancer database|prospective breast cancer database
16315342|NCT00534729|Drug|Weekly Carboplatin & Taxol w/concurrent RT|Chemotherapy
16315343|NCT00534703|Genetic|AAV1/SERCA2a|AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles)
16315497|NCT00533637|Drug|Cetirizine dihydrochloride (10 mg/ml) buffer solution|2x110μL in each nostril, as a single dose
16315344|NCT00534703|Drug|Placebo|Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.
16315345|NCT00534690|Procedure|One-Lung ventilation|Low Vt, High PEP
16315346|NCT00534690|Procedure|One-Llung ventilation|High Vt, low PEP
16315347|NCT00534677|Drug|Terlipressin|2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
16315348|NCT00534677|Drug|Octreotide|Octreotide 50mcg/hr infusion & a placebo of Terlipressin
16315349|NCT00534664|Device|TheraBionic device|Daily outpatient treatment with theraBionic device
16315350|NCT00534651|Drug|Paracetamol|Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
16315351|NCT00534638|Biological|Cervarix|Intramuscular injection, 3 doses
16315352|NCT00534638|Biological|Engerix-B|Intramuscular injection, 3 doses
16315353|NCT00534625|Drug|zileuton|Single injection of zileuton 150 mg
16315354|NCT00534625|Drug|placebo|Single injection of placebo
16315355|NCT00534625|Drug|zileuton|Single injection of zileuton 300 mg
16315356|NCT00534612|Procedure|aspiration biopsy|fine needle aspiration biopsy of the parotid gland masses
16315357|NCT00534599|Drug|Placebo|oral
16315358|NCT00534599|Drug|quetiapine fumarate XR|oral
16315359|NCT00534586|Drug|Propofol|TCI 0.5 mcg/ml 1.0 mcg/ml
16315360|NCT00534586|Drug|Remifentanil|continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min
16315361|NCT00534586|Drug|S-Ketamine|continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h
16315362|NCT00534586|Drug|Sevoflurane|via face mask 0.40 Vol% 0.80 Vol%
16315363|NCT00534573|Drug|Amisulpride, Moclobemide|Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
16315364|NCT00534560|Drug|Tonabersat|Tablets, 4 week dose titration and 16 weeks treatment at target dose of 40 mg per day
16315365|NCT00534560|Drug|Tonabersat|Tablets: 4 week titration and 16 weeks at target dose of 80 mg per day
16315366|NCT00534560|Drug|Placebo|Tablets; 4 week dose titration with 16 weeks at target dose
16315367|NCT00534547|Procedure|Duodenal Exclusion|duodenal-jejunal bypass
16315368|NCT00534534|Behavioral|Repeated behavioural intervention without any drugs|"All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period."
16315369|NCT00534521|Device|Posterior Tibial Nerve Device|The PTNS device (Urgent® PC) is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve (PTNS). It is a combination of a stimulator and a lead set. The stimulator is a battery powered, external pulse generator and is designed, constructed, and manufactured for multiple use in conjunction with the lead set. The lead set (comprised of the lead wires, needle electrode, and alcohol pad) transfers the electrical current from the stimulator to the tibial nerve via the needle electrode. The tibial nerve travels up the leg to the sacral nerve plexus which regulates the bladder and pelvic floor function.
16315370|NCT00534521|Device|Sham|This 2- piece needle, comprised of a needle handle and blunt-tip shaft feels like a slight prick when touched to the skin. However the shaft retracts as it appears to enter the skin but the skin is not punctured. The Streitberger needle specifically activates the dorsolateral prefrontal cortex, which is associated with the placebo effect.
16315371|NCT00534508|Drug|Tacrolimus Ointment 0.1%|Twice daily, 14 days treatment
16315372|NCT00534495|Biological|Rilonacept|2.2 mg/kg subcutaneously
16315373|NCT00534482|Behavioral|Enhanced Office|Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
16315374|NCT00534482|Behavioral|Conventional Office|Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
16315375|NCT00534482|Behavioral|AIM-HI program with enhanced feedback|Patient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
16315376|NCT00534482|Behavioral|AIM-HI program and regular feedback|Patients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
16315377|NCT00534469|Biological|aldesleukin|
16315378|NCT00534469|Biological|filgrastim|
16315379|NCT00534469|Drug|busulfan|
16315380|NCT00534469|Drug|cytarabine|
16315381|NCT00534469|Drug|etoposide|
16315382|NCT00534469|Drug|idarubicin|
16315383|NCT00534469|Procedure|autologous hematopoietic stem cell transplantation|
16315384|NCT00534469|Procedure|bone marrow transplantation|
16315385|NCT00534469|Procedure|peripheral blood stem cell transplantation|
16315386|NCT00534469|Radiation|total-body irradiation|
16315387|NCT00534456|Drug|Placebo|Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group.
16315388|NCT00534456|Drug|Darbepoetin alfa|Starting dose: 0.75 mcg/kg subcutaneously Q2W. Subsequent doses: Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL.
16315442|NCT00534092|Device|X STOP® Interspinous Process Decompression System|The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.
16315443|NCT00534079|Drug|Dornase alfa (Pulmozyme)|1 x 2,5 ml per day, inhalation use, for 28 days
16315389|NCT00534443|Procedure|Endoscopy of upper GI tract|"Upper GI endoscopy, one time on diagnosis and a second time 15 days after the end of the treatment. Gastric juice will be aspirated immediately after the entrance of the endoscope into the gastric lumen. Four biopsy specimens will be obtained from adjacent areas of the gastric antrum. Each biopsy will be used for in vitro culture. Blood will be sampled from one antecubital vein under aseptic conditions.
~Each patient will be given antisecretory treatment and - if necessary- eradication treatment of H. pylori according to international guidelines."
16315390|NCT00534430|Drug|busulfan|
16315391|NCT00534430|Drug|cyclosporine|
16315392|NCT00534430|Drug|etoposide|
16315393|NCT00534430|Drug|mycophenolate mofetil|
16315394|NCT00534430|Procedure|allogeneic bone marrow transplantation|
16315395|NCT00534430|Procedure|allogeneic hematopoietic stem cell transplantation|
16315396|NCT00534430|Procedure|peripheral blood stem cell transplantation|
16315397|NCT00534430|Radiation|total-body irradiation|
16315398|NCT00534417|Drug|capecitabine|Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg.
16315399|NCT00534417|Drug|fulvestrant|Fulvestrant will be given at 500mg on Day 1 followed by 250 mg on Days 15 and 29, then 250mg every 28 days(Q28d).
16315400|NCT00534404|Drug|Nicotine patches|Participants will wear nicotine patches.
16315401|NCT00534404|Behavioral|Telephone counseling|Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
16315402|NCT00534404|Behavioral|iQuit Smoking website|Participants will access the Project Quit (iQuit Smoking) website.
16315403|NCT00534391|Drug|neomycin sulfate, polymyxin B sulfate and gramicidin|to the effected eye 4 times a day
16315404|NCT00534391|Drug|Artificial tear|4 times daily
16315405|NCT00534378|Drug|Midazolam|The study drug was administered IM into the anterior thigh using the preloaded autoinjector. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects were assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.
16315406|NCT00534365|Device|tension-free vaginal tape|Retropubic mid-urethral sling
16315407|NCT00534365|Device|TVT-SECUR device|Mid-urethral mini-sling
16315408|NCT00534352|Drug|TMC125; darunavir; ritonavir|TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks
16315409|NCT00534339|Device|Easyband (Telemetrically adjustable gastric banding device)|EasyBand
16315410|NCT00534326|Procedure|Standard Reaming|Femoral reaming using standard reaming techniques of multiple reamers
16315411|NCT00534326|Procedure|Reaming/Irrigating/Aspirating|Reaming using the Reamer/Irrigator/Aspirating
16315412|NCT00534313|Drug|Abatacept|Solution, intravenous, monthly, short-term = 24 weeks (6 months)
16315413|NCT00534313|Drug|Placebo|Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
16315414|NCT00534300|Drug|Omegaven|Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
16315415|NCT00534300|Drug|Isotonic saline|Intravenous infusion, 100 mL, 25mL/h
16315416|NCT00534287|Drug|meropenem|Empirical antibiotic therapy with 3 x 1 g intravenous meropenem. Dosage is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
16315417|NCT00534287|Drug|meropenem, moxifloxacin|Empirical antibiotic therapy with 3 x 1 g intravenous meropenem plus 1 x 400 mg intravenous moxifloxacin. Dosage of meropenem is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
16315418|NCT00534274|Other|3'-deoxy-3'-[18F]fluorothymidine|
16315419|NCT00534261|Drug|Interferon beta-1a|IM injection
16315420|NCT00534248|Biological|Zoster Vaccine, Live (Zostavax™)|A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
16315421|NCT00534248|Biological|Comparator: Placebo|A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.
16315422|NCT00534235|Procedure|Decompression|Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
16315423|NCT00534235|Device|Posterolateral Fusion and Implantation of Pedicle Screws|
16315424|NCT00534235|Device|Implantation of coflex Interlaminar Technology|
16315425|NCT00534209|Biological|Allogeneic B7.1/HLA-A1|Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally
16315426|NCT00534209|Other|Placebo|Given intradermally
16315427|NCT00534196|Radiation|Permanent iodine-125 (Brachytherapy)|Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
16315428|NCT00534183|Drug|Olanzapine|Olanzapine in dose range of 10-20mg
16315429|NCT00534183|Drug|Risperidone|Risperidone 1-6mg
16315430|NCT00534183|Drug|Haloperidol|Haloperidol 10-20mg
16315431|NCT00534170|Dietary Supplement|Probiotic (Yakult)|It is a dietary supplement ,65 ml containing 15 billion lactobacillus
16315432|NCT00534144|Drug|iron sucrose injection, USP|iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
16315433|NCT00534144|Drug|sodium ferric gluconate complex in sucrose injection|sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
16315434|NCT00534131|Procedure|Standard abdominal approach for rectal excision|Standard abdominal approach for rectal excision
16315435|NCT00534131|Procedure|APPEAR Procedure|Perineal incision to reach the distal rectum
16315436|NCT00534131|Procedure|Proctectomy|standard rectal excision which does not preserve the anal canal
16315437|NCT00534118|Biological|donor lymphocytes|Given IV
16315438|NCT00534105|Other|Total Cholesterol|
16315439|NCT00534105|Other|Triglyceride|
16315440|NCT00534105|Other|HDL|
16315441|NCT00534105|Other|LDL|
16315444|NCT00534079|Drug|isotonic saline|1 x 2,5 ml per day, inhalation use, for 28 days
16315498|NCT00533637|Drug|Placebo|Citrate buffer with preservatives
16315445|NCT00534053|Other|Mailed Educational Reminder|1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.
16315446|NCT00534027|Drug|AMG 655|AMG 655 is a monoclonal antibody directed against TR-2.
16315447|NCT00534027|Other|AMG 655 placebo|Inactive dummy AMG 655 (to maintain blind)
16315448|NCT00534014|Dietary Supplement|Vitamin C|Arm A = 0 mg Vitamin C, Arm B = 250 mg Vitamin C, Arm C = 500 mg Vitamin C, Arm D = 1000 mg Vitamin C
16315449|NCT00534001|Drug|bupropion hydrochloride|Given orally
16315450|NCT00534001|Other|placebo|Given orally
16315451|NCT00533988|Device|Antimicrobial impregnated catheter (5593)|Comparison of 14-day placement of a standard triple lumen (ARROW Standard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US) versus an antimicrobial impregnated catheter (Chlorhexidine-silver sulfadiazine)(ARROWgard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US)
16315452|NCT00533962|Drug|Anterior Juxtascleral Depot of Anecortave Acetate|
16315453|NCT00533949|Biological|Cetuximab|Loading dose: 400 mg/m2, IV, one week prior to start of radiation therapy (RT). Then, beginning day 1 of RT, 250 mg/m2, IV, weekly; for 60 Gy arm for 15 weeks, for 74 Gy arm for 16 weeks.
16315454|NCT00533949|Drug|Carboplatin|"Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy; for 74 Gy arms, on day 43 as well.
~Consolidation, 3 weeks after completion of RT, AUC=6, IV, days 1 and 22."
16315455|NCT00533949|Drug|Paclitaxel|"Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy (RT); for 74 Gy arms, on day 43 as well.
~Consolidation, 3 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22."
16315456|NCT00533949|Radiation|60 Gy RT|Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.
16315457|NCT00533949|Radiation|74 Gy RT|Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.
16315458|NCT00533936|Biological|trastuzumab|
16315459|NCT00533936|Drug|cyclophosphamide|
16315460|NCT00533936|Drug|doxorubicin hydrochloride|
16315461|NCT00533936|Drug|fluorouracil|
16315462|NCT00533936|Drug|paclitaxel|
16315463|NCT00533936|Procedure|adjuvant therapy|
16315464|NCT00533936|Procedure|conventional surgery|
16315465|NCT00533936|Procedure|neoadjuvant therapy|
16315466|NCT00533923|Drug|Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF|intravenous
16315467|NCT00533910|Drug|Rifaximin|550mg BID rifaximin for 8 weeks
16315468|NCT00533910|Drug|placebo|same as the experimental arm
16315469|NCT00533897|Drug|Abatacept|Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)
16315470|NCT00533897|Drug|Placebo|Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)
16315471|NCT00533884|Other|Assessment of therapy complications|Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
16315472|NCT00533884|Other|Neurocognitive assessment|Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
16315473|NCT00533884|Other|Quality-of-life assessment|Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment
16315474|NCT00533858|Drug|lacidipine (4 mg) or losartan (50 mg)|lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 AM) for 12 weeks
16315475|NCT00533845|Drug|On-Q Pain Pump|Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
16315476|NCT00533832|Device|vagus nerve stimulation (VNS)|"intermittent vagus nerve stimulation
~Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase."
16315477|NCT00533819|Other|6 months of healthy physical activity|half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week
16315478|NCT00533806|Behavioral|Cognitive Behavior Therapy|CBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management.
16315479|NCT00533806|Behavioral|Relaxation Therapy|Relaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing.
16315480|NCT00533793|Procedure|open fracture reduction|internal fracture fixation: osteosynthesis plates or intra-medullary nails
16315481|NCT00533780|Procedure|Healing Touch|
16315482|NCT00533754|Procedure|drawing blood|
16315483|NCT00533741|Drug|Aluminum hydroxide|Adjuvant; administered with SARS-CoV vaccine.
16315484|NCT00533741|Drug|Placebo|Saline for injection.
16315485|NCT00533741|Biological|SARS-CoV|Whole-virus vaccine, grown in certified Vero cells and doubly inactivated by treatment with formalin and ultraviolet light (UV). Supplied in liquid formulation in single dose vials with and without aluminum hydroxide as an adjuvant. Doses supplied without aluminum hydroxide will be 2.5, 5.0 and 10.0 mcg. Doses supplied with aluminum hydroxide adjuvant will be 2.5 and 5.0 mcg.
16315486|NCT00533728|Drug|Soluble beta-glucan (SBG)|
16315487|NCT00533702|Biological|IMC-1121B (ramucirumab)|10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
16315488|NCT00533702|Drug|Dacarbazine|1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
16315489|NCT00533689|Procedure|Electroretinography (ERG), Visual Evoked Potentials (VEP)|
16315490|NCT00533676|Drug|MK0524A, /Duration of Treatment : 8 Weeks|
16315491|NCT00533676|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks|
16315492|NCT00533663|Procedure|Healing Touch|every other week (during their infusion)
16315493|NCT00533663|Drug|Standard care|
16315494|NCT00533663|Drug|guided relaxation|
16315495|NCT00533650|Drug|MK0429|
16315496|NCT00533637|Drug|Cetirizine dihydrochloride (10 mg/ml) liposomal formulation|2x110μL in each nostril twice daily for 7 days
16315499|NCT00533624|Drug|Mycophenolate Sodium Delayed Release Tablets|Myfortic® 1,440 mg/day
16315500|NCT00533624|Drug|Mycophenolate Mofetil|Cellcept® 2,000 mg/day
16315501|NCT00533611|Drug|MK0524A, /Duration of Treatment : 4 Weeks|
16315502|NCT00533611|Drug|Comparator : niacin /Duration of Treatment : 1 Weeks|
16315503|NCT00533598|Drug|MK0557|
16315504|NCT00533585|Drug|BAY 43-9006|Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
16315505|NCT00533585|Drug|Paclitaxel|200 mg/m^2 By Vein Over 3 Hours on Day 1.
16315506|NCT00533585|Drug|Carboplatin|Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
16315507|NCT00533585|Drug|Bevacizumab|Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
16315508|NCT00533559|Drug|sodium phenylbutyrate|buphenyl, 7.5 gm/day for two weeks for two studies, one with saline and one admission with intralipid and heparin
16315509|NCT00533559|Drug|Placebo|Placebo comparator
16315510|NCT00533546|Drug|Activated Protein C|Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset
16315511|NCT00533533|Drug|docetaxel, oxaliplatin|"Oxaliplatin will be administered in combination with docetaxel as a first-line chemotherapy in advanced gastric cancer patients. Each cycle is repeated every 3 weeks.
~Docetaxel Oxaliplatin Level 1 60 mg/m2/day 1 100 mg/m2/day 1 Level 2 75 mg/m2/day 1 100 mg/m2/day 1 Level 3 75 mg/m2/day 1 130 mg/m2/day 1"
16315512|NCT00533520|Drug|ranibizumab|Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
16315513|NCT00533507|Biological|Synflorix|Intramuscular injection, 3 doses.
16315514|NCT00533507|Biological|Infanrix hexa|Intramuscular injection, 3 doses.
16315515|NCT00533507|Biological|Rotarix|Oral, 2 doses.
16315516|NCT00533494|Behavioral|physician feedback (A)|Feedback information to physicians
16315517|NCT00533481|Drug|MK0557|
16315518|NCT00533468|Drug|Lidocaine Cream 4%|Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
16315519|NCT00533455|Drug|Gabapentin|
16315520|NCT00533442|Drug|Rapamycin|Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
16315521|NCT00533442|Drug|Mycophenolate Mofetil|MMF 1 gm BID beginning 1st day postoperative day
16315522|NCT00533442|Drug|Tacrolimus|Part of standard maintenance.
16315523|NCT00533442|Drug|Steroids|Part of standard maintenance
16315524|NCT00533429|Drug|enzastaurin|1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression
16315525|NCT00533429|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
16315526|NCT00533429|Drug|carboplatin|Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
16315527|NCT00533429|Drug|bevacizumab|15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
16315528|NCT00533429|Drug|Placebo|oral, daily
16315529|NCT00533416|Drug|ON 01910 Na|
16315530|NCT00533403|Drug|MK0686|
16315531|NCT00533390|Drug|efavirenz|600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS
16315532|NCT00533377|Drug|CP-533, 536|Active study drug
16315533|NCT00533377|Drug|Placebo|Placebo vehicle
16315534|NCT00533377|Procedure|Standard of Care|Standard surgical procedure
16315535|NCT00533377|Drug|CP-533,536|Active study drug
16315536|NCT00533377|Drug|CP-533,536|Active study drug
16315537|NCT00533377|Drug|CP-533,536|Active study drug
16315538|NCT00533364|Drug|SBG (Soluble beta-glucan)|Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.
16315539|NCT00533351|Drug|AGN201781|AGN201781 50 mg capsules three-times daily for 2 weeks
16315540|NCT00533351|Drug|placebo|placebo 50 mg capsules three-times daily for 2 weeks
16315541|NCT00533338|Behavioral|Weight Gain Prevention Program|Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.
16315542|NCT00533338|Behavioral|Questionnaire|Packet of questionnaires will be completed.
16315543|NCT00533312|Drug|Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks|
16315544|NCT00533312|Drug|MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks|
16315545|NCT00533312|Drug|Comparator : niacin / Duraton of Treatment: 4 Weeks|
16315546|NCT00533299|Drug|Hydralazine and magnesium valproate|Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d.
16315547|NCT00533299|Drug|Placebo|Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.
16315548|NCT00533286|Drug|benzodiacepine|diazepam (2 x 5 mg/ die)
16315549|NCT00533273|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500 0.58 mg/placebo into the cord of the affected hand in the double-blind phase. In the open-label extension phase, subjects could have received up to five additional injections of AA4500, with each injection separated by at least 30 days. Individual joints could have received up to a maximum of three AA4500 injections.
16315550|NCT00533247|Drug|Celecoxib|
16315551|NCT00533234|Device|ExploR® Modular Radial Head|The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
16315552|NCT00533221|Drug|somatotropin|0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
16317744|NCT00516295|Biological|bevacizumab|Given IV
16315553|NCT00533221|Drug|Placebo|0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
16315554|NCT00533208|Drug|MK0524|
16315555|NCT00533195|Drug|5-Methoxypsoralen|1,2 mg/kg 2 hours before UVA irradiation p.o. 3 times weekly for 5 weeks
16315556|NCT00533195|Device|UVA1 phototherapy|"Treatment 5 x week for 3 weeks (=15 irradiations). Determination of the UVA 1 MED prior to treatment. Start with 1 MED. Increments of the UVA 1 dose in 20 % steps until a maximal dose of 70 J/cm2 in the absence of an erythemal reaction and by good tolerability.
~No maintenance therapy except emollients."
16315557|NCT00533169|Drug|ZD6474|Part A = Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = Starting dose 50 mg/m^2 by mouth daily on days 2-28.
16315558|NCT00533169|Drug|Retinoic Acid|Part B, C = 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
16315559|NCT00533156|Device|Vascular access site closure (7F Ensure)|
16315560|NCT00533143|Other|non invasive ventilation (NIV)|NIV is a form of mechanical ventilation delivered through a face or nasal mask and therefore not requiring endotracheal intubation. It will be delivered according to the compliance and tolerance of the patients.
16315561|NCT00533130|Procedure|clinical evaluation|analyze the x ray from each patient and evaluate the treatment y development of bone healing.
16315562|NCT00533130|Procedure|observational study|evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months
16315563|NCT00533117|Drug|Fluoxetine|Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
16315564|NCT00533117|Behavioral|Dialectical Behavior Therapy|Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
16315565|NCT00533117|Behavioral|Supportive psychotherapy|Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
16315566|NCT00533104|Procedure|BM-MNC preparation|"For autologous bone marrow - mononuclear cells preparation, 500ml of bone marrow are collected under general anaesthesia; mononuclear cells are separated using a blood-cells separator (COBE SPECTRA, GAMBRO BCT) and concentrated to produce a final volume of 40ml.
~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."
16315567|NCT00533104|Procedure|PB-MNC preparation|"Peripheral blood - mononuclear cells are collected through cytapheresis with the same blood-cells separator which is adjusted to obtain a 40 mL cell product. No previous mobilization with hematopoïetic growth-factor is administered.
~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."
16315568|NCT00533091|Biological|MEDI-545|"MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
~Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
16315569|NCT00533091|Other|Placebo|"Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
~Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 12 weeks.
~Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks."
16315570|NCT00533078|Dietary Supplement|omegaven|Trial participants are prescribed TPN by the attending physician as soon as indicated, which will be administered via a central venous line over a time period of approximately 20 hours per day. The formulation given to all patients is Nutriflex lipid spezial®, an emulsion containing the full supply of carbohydrates, amino acids and lipids (SO:MCT = 1:1) with a total energy content of 2215 kcal in a 1875 ml volume, see Investigator's Brochure. In addition, they receive daily infusional Omegaven® 100 ml over 4 hours, which equal FO 10 g/d or omega-3 PUFA 3-6 g/d.
16315571|NCT00533065|Drug|Donepezil|week1 - week12: 1 tablet per day (5mg) week13 - week52: 1 tablet per day (10mg)
16315572|NCT00533052|Behavioral|Affective and Cognitive Skills Training|24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training
16315573|NCT00533039|Drug|Varespladib (A-002)|250mg tablets BID for 3-5 days pre-angioplasty and 5 days post-angioplasty.
16315574|NCT00533039|Drug|placebo|250mg tablets BID 3-5 days pre-angioplasty and 5 days post-angioplasty.
16315575|NCT00533026|Drug|Duloxetine|
16315576|NCT00533026|Drug|Warfarin|
16315577|NCT00533013|Other|Usual Care|Management of heart failure is provided by primary practitioners and consultant cardiologists
16315578|NCT00533013|Other|Disease Management and Tele-Monitoring|Management of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate.
16315579|NCT00533000|Procedure|Smoking cessation|Weekly smoking cessation by professional counseling and nicotine substitute on request
16315580|NCT00532987|Behavioral|Questionnaire|Questionnaire form to be completed by patient
16315581|NCT00532974|Biological|EP1090|Low dose
16315582|NCT00532974|Biological|EP1090|High dose
16315583|NCT00532961|Drug|Loteprednol etabonate 0.5% and tobramycin 0.3%|ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
16315584|NCT00532961|Drug|Dexamethasone 0.1% and tobramycin 0.3%|ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.
16315585|NCT00532948|Drug|capecitabine [Xeloda]|500mg/m2 po bid (starting dose)
16315586|NCT00532935|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
16315587|NCT00532935|Drug|Comparator: pioglitazone|pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
16315588|NCT00532909|Drug|Vandetanib|100mg or 300mg By mouth every day continuous
16317827|NCT00515489|Drug|Risperidone|as prescribed
16315589|NCT00532909|Drug|Capecitabine|Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
16315590|NCT00532909|Drug|Oxaliplatin|dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
16315591|NCT00532909|Drug|Bevacizumab|Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)
16315592|NCT00532883|Drug|Hydroxyurea|HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
16315593|NCT00532883|Drug|Magnesium Pidolate|HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)
16315594|NCT00532883|Other|Placebo Pills and Placebo Liquid|HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
16315595|NCT00532870|Other|laparoscopic|
16315596|NCT00532857|Drug|Paclitaxel/Gemcitabine/Trastuzumab|80 mg/m2 of paclitaxel 1,200 mg/m2 of gemcitabine, day 1, day 8 every 3-week. trastuzumab at a dose of 4 mg/kg IV on D1 of first treatment cycle subsequently given weekly at a dose of 2 mg/kg
16315597|NCT00532844|Drug|Sapropterin Dihydrochloride|Sapropterin Dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.
16315598|NCT00532844|Drug|Sapropterin Dihydrochloride and Vitamin C|Sapropterin Dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.
16315599|NCT00532818|Drug|Hydralazine and magnesium valproate|Cisplatin + Topotecan plus hydralazine valproate
16315600|NCT00532818|Drug|Placebo|Cisplatin + Topotecan plus placebo
16315601|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
16315602|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
16315603|NCT00532792|Biological|A/H5N1|Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
16315604|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
16315605|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
16315606|NCT00532792|Biological|A/H5N1|Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
16315607|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
16315608|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
16315609|NCT00532792|Biological|A/H5N1|High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
16315610|NCT00532792|Biological|Placebo|Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
16315611|NCT00532779|Drug|Naltrexone SR 16 mg/Bupropion SR 360 mg /day|
16315612|NCT00532779|Drug|Naltrexone SR 32 mg/Bupropion SR 360 mg /day|
16315613|NCT00532779|Drug|Placebo|
16315614|NCT00532779|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
16315615|NCT00532766|Drug|Jusline|
16315616|NCT00532753|Behavioral|Community Empowerment|
16315617|NCT00532740|Radiation|Yttrium Y 90 glass microspheres|Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
16315618|NCT00532727|Drug|Carboplatin|AUC 6 every 3 weeks for six cycles (18 weeks)
16315619|NCT00532727|Drug|Docetaxel|100mg/m2 every 3 weeks for six cycles (18 weeks)
16315620|NCT00532714|Drug|Irinotecan plus capecitabine|"Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period.
~Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period)."
16315621|NCT00532701|Drug|Peg-IFN + WB RBV for 16 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 5-16"
16315622|NCT00532701|Drug|Peg-IFN + LD RBV for 16 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-6
~Rapid virologic response (RVR) at week 4 of therapy: achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16"
16315623|NCT00532701|Drug|Peg-IFN + WB RBV for 24 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: not achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24"
16315624|NCT00532701|Drug|Peg-IFN + WB RBV for 48 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (< 75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) from weeks 1-4
~Rapid virologic response (RVR) at week 4 of therapy: not achieved
~Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48"
16315625|NCT00532701|Drug|Peg-IFN + LD RBV for 24 weeks|"Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24
~Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved"
16315626|NCT00532688|Drug|N-acetylcysteine|28 days of oral n-acetylcysteine (500mg bd)(in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.
16315627|NCT00532675|Drug|LBH589|PAN 5 mg and PAN 20 mg capsules
16315628|NCT00532675|Combination Product|Lenalidomide|Lenalidomide 5mg or 25 mg
16315629|NCT00532662|Drug|S(+)-ketamine|epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
16315630|NCT00532636|Procedure|Ventilation|Mask ventilation in neutral and head extension position
16315631|NCT00532636|Procedure|Ventilation|Mask ventilation in neutral and head extension position
16315632|NCT00532623|Drug|Gemcitabine plus Vinorelbine|Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles
16315633|NCT00532623|Drug|Sequential|"Gemcitabine monotherapy followed by Vinorelbine monotherapy:
~-Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles."
16315634|NCT00532610|Drug|GSK189075|
16315635|NCT00532597|Procedure|On-line hemodiafiltration|
16315636|NCT00532597|Procedure|Low flux hemodialysis|
16315637|NCT00532584|Drug|Beclomethasone|The treatment with inhaled beclomethasone will be administered to Group A from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
16315638|NCT00532571|Drug|CoQ10|
16315639|NCT00532558|Drug|Lapaquistat acetate|Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.
16315640|NCT00532558|Drug|Placebo|Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks.
16315641|NCT00532545|Drug|Teriparatide|Teriparatide 20 micrograms/daily subcutaneously
16315642|NCT00532532|Drug|tolperisone HCl|Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
16315643|NCT00532532|Drug|tolperisone HCl|High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
16315644|NCT00532532|Drug|tolperisone HCl|Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
16315645|NCT00532519|Drug|citalopram (cipralex)|10-20 mg/day, for 12 weeks.
16315646|NCT00532506|Drug|SK-0403|
16315647|NCT00532493|Drug|prazosin|"Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
16315648|NCT00532493|Other|placebo|"sugar pill"
16315649|NCT00532480|Drug|Duloxetine|60 mg capsules
16315650|NCT00532467|Drug|SRX251|
16315651|NCT00532454|Drug|Tamoxifen|tamoxifen 20mg, PO, QD until disease progression
16315652|NCT00532441|Drug|Erlotinib|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
16315653|NCT00532441|Drug|Docetaxel|Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
16315654|NCT00532428|Drug|Raloxifene|60 mg QD
16315655|NCT00532428|Drug|Raloxifene|120 mg QD
16315656|NCT00532428|Drug|Placebo|Placebo
16315657|NCT00532415|Drug|Triamcinolone Acetonide Injectable Suspension|Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
16315658|NCT00532389|Drug|LBH589|
16315659|NCT00532350|Drug|QAT370|
16315660|NCT00532350|Drug|Placebo|
16315661|NCT00532350|Drug|Tiotropium|
16315662|NCT00532337|Drug|ONO-5334|Placebo - 24/mos.
16315663|NCT00532337|Drug|ONO-5334|100mg QD /24 months
16315664|NCT00532337|Drug|ONO-5334|50mg BID /24 mos.
16315665|NCT00532337|Drug|ONO-5334|300mg QD /24 mos.
16315666|NCT00532337|Drug|ONO-5334|Alendronate 70mg once weekly / 24 mos
16315667|NCT00532324|Other|CA-MRSA Decolonization|In later stages of this study, women found to be nasally and/or vaginally colonized with CA-MRSA will be randomized to receive postpartum, either: 1) attempted decolonization with intranasal mupirocin twice a day for one to two weeks with or without diluted chlorhexidine or Clorox baths two to three times a week for one to two weeks or, 2) no intervention. The primary study is observational only.
16315668|NCT00532311|Drug|Lapaquistat acetate and stable statin therapy|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.
16315669|NCT00532311|Drug|Stable statin therapy|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.
16315670|NCT00532298|Biological|GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]|Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
16315671|NCT00532298|Biological|GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]|Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
16315672|NCT00532298|Biological|Fluarix [NH 2006/07 season]|Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
16315673|NCT00532298|Biological|Fluarix [NH 2007/08 season]|Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
16315674|NCT00532285|Drug|Paclitaxel/Gemcitabine|Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.
16315675|NCT00532272|Drug|Letrozole ,Goserelin|Letrozole 2.5mg qd. Goserlin 3.6mg monthly(premenopausal)
16315676|NCT00532259|Drug|CT-011|IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
16315677|NCT00532246|Drug|raloxifene|
16315678|NCT00532246|Drug|Placebo|
16315679|NCT00532233|Drug|QAX576|
16315680|NCT00532220|Drug|Ibandronate IV|Ibandronate IV (Bonviva® IV), 10.5 mg divided in 4 single infusions within 2 weeks(1x1.5 mg, 3x3 mg), followed by a fifth infusion after 3 months (V4)
16315681|NCT00532220|Drug|Placebo|Placebo IV, divided in 4 single infusions within 2 weeks, followed by a fifth infusion after 3 months (V4)
16315682|NCT00532207|Drug|teriparatide|subcutaneous 20 micrograms
16315683|NCT00532194|Drug|cediranib|Once-daily oral tablet starting dose 20mg
16315684|NCT00532181|Behavioral|Savings Behavior and Consumer's Approach to Risk|
16315685|NCT00532168|Drug|tenofovir + emtricitabine + efavirenz|tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
16315686|NCT00532168|Drug|tenofovir + emtricitabine + lopinavir-ritonavir|tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
16315687|NCT00532168|Drug|tenofovir + emtricitabine + atazanavir-ritonavir|tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
16315688|NCT00532155|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
16315689|NCT00532155|Drug|Placebo|Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
16315690|NCT00532155|Drug|Docetaxel (Taxotere®)|75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
16315691|NCT00532155|Drug|Dexamethasone (pre- and post-medication for docetaxel)|As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
16315692|NCT00532142|Drug|Intravitreal Triamcinolone|
16315693|NCT00532142|Procedure|Radial Optic Neurotomy|
16315694|NCT00532142|Other|Placebo - Sham Intravitreal Injection|
16315695|NCT00532129|Drug|Rituximab|375mg/m^2 IV on Day 1 of Cycle 1; 500mg/m^2 on Day 1 of Cycles 2-6.
16315696|NCT00532129|Drug|Chlorambucil|10 mg/m^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.
16315697|NCT00532116|Drug|EMSAM (Selegiline Transdermal System) 6mg|STS 6mg/24hr
16315698|NCT00532116|Drug|EMSAM (Selegiline Transdermal System) 12mg|EMSAm 12mg/24Hr
16315699|NCT00532090|Drug|RG4733|Administered orally daily at ascending doses to successive cohorts of patients
16315700|NCT00532090|Drug|RG4733|Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
16315701|NCT00532090|Drug|RG4733|Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
16315702|NCT00532077|Drug|rhPTH(1-34)|
16315703|NCT00532077|Drug|SB-751689 100 mg|
16315704|NCT00532077|Drug|SB-751689 400 mg|
16315705|NCT00532064|Procedure|Biospecimen Collection|Undergo collection of blood
16315706|NCT00532064|Other|Questionnaire Administration|Ancillary studies
16315707|NCT00532051|Device|OCT measurements|This study is about a new imaging method to study the front part of the eye. This imaging method is called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography), and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systemsThe measurements from the OCT systems are used in selecting IOL power.
16315708|NCT00532038|Drug|ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)|Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.
16315709|NCT00532025|Drug|Sorafenib|Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.
16315710|NCT00532012|Drug|RhuDex®|
16315711|NCT00531999|Drug|Raltegravir then lopinavir/ritonavir|raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study
16315712|NCT00531999|Drug|Lopinavir/ritonavir then raltegravir|lopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study
16315713|NCT00531986|Drug|Lopinavir-Monotherapy|Patients on triple HAART will be switched to LPV/r-monotherapy
16315714|NCT00531986|Drug|HAART|Patients will continued their current HAART
16315715|NCT00531973|Drug|liposomal doxorubicin|5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
16315716|NCT00531973|Drug|epirubicin|5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
16315717|NCT00531960|Drug|Erlotinib|150 mg, PO, daily
16315718|NCT00531960|Drug|Bevacizumab|15 mg/kg, IV, Day 1 of Cycles 1 through 7
16315719|NCT00531960|Drug|Standard platinum-based chemotherapy|At the discretion of the investigator
16315720|NCT00531947|Drug|Selegiline Transdermal System|EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
16315721|NCT00531947|Drug|Placebo|Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
16315722|NCT00531934|Drug|Doxycline|100mg po daily
16315723|NCT00531934|Drug|erlotinib [Tarceva]|150mg po daily
16315724|NCT00531908|Drug|furosemide|furosemide
16315725|NCT00531895|Drug|duloxetine|duloxetine 60 mg/d
16315726|NCT00531882|Drug|Pioglitazone|30 mg once a day
16315727|NCT00531882|Drug|Simvastatin|40 mg once a day
16315728|NCT00531882|Drug|Ibuprofen|Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
16315729|NCT00531869|Behavioral|biases towards products|
16315730|NCT00531856|Drug|Inhaled carbon monoxide|0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
16315731|NCT00531856|Drug|Inhaled carbon monoxide|2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
16318038|NCT00514007|Drug|OSI-906|OSI-906 administered orally
16315732|NCT00531856|Drug|Inhaled carbon monoxide|3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
16315733|NCT00531856|Drug|Inhaled Carbon Monoxide|3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
16315734|NCT00531856|Drug|Inhaled Carbon Monoxide|2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.
16315735|NCT00531843|Drug|fondaparinux sodium|fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians.
16315736|NCT00531843|Device|sequential compression devices|Sequential compression devices at all times during the patient's hospital admission will be used in patients who have a contraindication to pharmacologic DVT prophylaxis. This is already the current standard of care.
16315737|NCT00531817|Drug|Tocilizumab|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
16315738|NCT00531817|Drug|Placebo|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
16315739|NCT00531817|Drug|Permitted DMARDs|As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
16315740|NCT00531804|Drug|gantenerumab|Administered iv at escalating doses (7 cohorts)
16315741|NCT00531791|Drug|prednisone group|Patients in the prednisone group will receive prednisone 40 mg per day with concomitant placebo diskus 2 inhalations twice a day for 10 days. All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.
16315742|NCT00531791|Drug|Advair group|Patients in the second group will receive Advair® 50/500 ug 2 inhalations twice daily with placebo pills once a day for 10 days (twice the regular dosage). All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.
16315743|NCT00531765|Other|sodium bicarbonate infusion|short infusion of sodium bicarbonate
16315744|NCT00531752|Drug|PF-03654746|Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21
16315745|NCT00531752|Drug|Placebo capsules|Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.
16315746|NCT00531752|Drug|PF-03654746|Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks
16315747|NCT00531739|Other|Polylactic Acid Sheet|SurgiWrapTM film will be secured in two study areas: directly below the abdominal incision and on the posterior pelvic rim. The film will not be wrapped directly around an anastomosis.
16315748|NCT00531726|Device|DBS of Cg25|
16315749|NCT00531713|Drug|Triiodothyronine|50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3
16315750|NCT00531700|Other|Health messaging|Combinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects
16315751|NCT00531700|Other|Health messages|community level health messages unrelated to the study originating exposures
16315752|NCT00531687|Drug|Paclitaxel|"Paclitaxel 175 mg/m2 day 1 (3 hour infusion)
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered."
16315753|NCT00531687|Drug|Cisplatin|"cisplatin 50 mg/m2 day 1 and 2
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered."
16315754|NCT00531687|Drug|Gemcitabine|"gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion)
~Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered"
16315755|NCT00531674|Dietary Supplement|fortified milk-based beverage|Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
16315756|NCT00531674|Dietary Supplement|Sprinkles|Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
16315757|NCT00531674|Dietary Supplement|tablets|Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
16315758|NCT00531674|Dietary Supplement|Fortified milk-based pap|Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.
16315759|NCT00531674|Dietary Supplement|Sprinkles|Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
16315760|NCT00531674|Dietary Supplement|Syrup|Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
16315761|NCT00531661|Device|HF Pressure Measurement System|A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
16315762|NCT00531635|Drug|Mycophenolate Mofetil|Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil
16315763|NCT00531622|Drug|saredutant (SR48968)|oral administration, capsules
16315764|NCT00531622|Drug|escitalopram|oral administration, capsules
16315765|NCT00531622|Drug|placebo|oral administration, capsules
16315766|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 6mg/24Hr|EMSAM 6mg/24HR
16315767|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 9mg/24Hr|EMSAM 9mg/24Hr
16315768|NCT00531596|Drug|EMSAM (Selegiline Transdermal System) 12mg/24hr|EMSAM 12mg/24Hr
16315769|NCT00531583|Drug|Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation|Autologous PBSCT
16315770|NCT00531557|Drug|Darunavir ritonavir|
16315771|NCT00531544|Drug|SU011248|SU011248 Expanded Access Protocol for Systemic Therapy
16315772|NCT00531518|Drug|aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine|Oral, daily, generally at lower than manufacturer's recommendations
16315859|NCT00530777|Drug|valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
16318349|NCT00511875|Drug|placebo|placebo taken once daily for 24 months
16315773|NCT00531518|Behavioral|Psychoeducational multifamily group treatment|Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
16315774|NCT00531518|Behavioral|Supported employment and education|Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
16315775|NCT00531492|Behavioral|TK as soon as possible within 24 hours after birth|Start TK as soon as possible within 24 hours after birth
16315776|NCT00531492|Other|Conventional care|Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
16315777|NCT00531479|Drug|voriconazole|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
16315778|NCT00531479|Drug|anidulafungin|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
16315779|NCT00531479|Drug|voriconazole|"First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
~Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
~Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
~OR
~Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
~Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy."
16315780|NCT00531466|Drug|tolperisone HCl (AV650)|One tablet orally three times a day for 28 days
16315781|NCT00531466|Drug|Placebo|One tablet orally three times a day for 28 days
16315782|NCT00531453|Drug|bortezomib, dexamethasone, and thalidomide|"VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21)
~Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
~Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime)."
16315783|NCT00531453|Drug|bortezomib, dexamethasone, thalidomide, and cyclophosphamide|"VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21).
~Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
~Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).
~Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles."
16315784|NCT00531440|Drug|Everolimus (RAD001)|
16315785|NCT00531427|Drug|Buprenorphine|transdermal system 10 and 20 applied for 7-day wear
16315786|NCT00531427|Drug|Placebo|transdermal system (placebo) applied for 7-day wear
16315787|NCT00531401|Drug|Salirasib|600mg BID until disease progression or unacceptable toxicity occurs.
16315788|NCT00531375|Device|Silicone hydrogel contact lens|
16315789|NCT00531362|Drug|Plain aspirin|Plain aspirin 75 mg or 150 mg
16315790|NCT00531349|Procedure|propofol general anesthesia|Regional analgesia combined with sedation or a propofol general anesthesia
16315791|NCT00531349|Drug|Sevoflurane|General anesthesia
16315792|NCT00531336|Drug|intravitreal injection of Bevacizumab (Avastin)|1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2
16315793|NCT00531336|Drug|Pegaptanib (Macugen)|0.3 mg intravitreally applied every 6 weeks as long as required
16315794|NCT00531323|Drug|TMC125 once daily|Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
16315795|NCT00531323|Drug|TMC125 twice daily|Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
16315796|NCT00531310|Drug|Reduced Intensity Conditioning, Busulfan and Fludarabine|Busulfan and Fludarabine
16315797|NCT00531297|Procedure|endoscopic posterior mesorectal resection|6 weeks after local excision of a T1 rectal cancer a rectum sparing endoscopic removal of the dorsal part of the mesorectum by EPMR is performed.
16315798|NCT00531284|Drug|Carfilzomib|Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
16315799|NCT00531284|Drug|Dexamethasone|Administered orally or by IV infusion prior to carfilzomib
16315800|NCT00531271|Drug|ABI-008 (nab-docetaxel)|ABI-008; 60-200 mg/m²; Intravenous infusion every 3 weeks.
16315801|NCT00531258|Device|rTMS|Bilateral rTMS
16315802|NCT00531258|Device|Sham rTMS|sham rTMS
16315803|NCT00531245|Drug|TS-1, oxaliplatin|Oxaliplatin(130 mg/m2) day 1, intravenously TS-1 at a dose of 60, 70, 80, 90, 100, 110, 120 mg/m2 given orally starting day 1 until day 14(2 weeks ON, 1 weeks OFF), every 3 weeks
16315804|NCT00531232|Drug|clofarabine|Oral daily x 5 every 28 days. 25 mg/day. Up to 8 cycles
16315805|NCT00531219|Procedure|Transgastric Appendectomy|The appendix will be removed through an incision in the stomach and pulled out through the mouth
16315806|NCT00531219|Procedure|Transgastric Cholecystectomy|The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.
16315807|NCT00531206|Drug|Tipranavir|
16315808|NCT00531206|Drug|Ritonavir|low dose
16315809|NCT00531193|Drug|BIIB014|oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol
16315810|NCT00531193|Other|[11C]SCH442416|11C]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. [11C]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan.
16315811|NCT00531180|Procedure|4D CT scans|Three 4D CT scans will be performed. After you are out of the CT scanner, ventilation images will be calculated from the 4D CT images and will be compared with the standard ventilation imaging method.
16315812|NCT00531180|Procedure|Lung Function Imaging|Lung function imaging performed to provide information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.
16315813|NCT00531167|Drug|combination of lamivudine+adefovir vs entecavir|Lamivudine 100 mg/day, Adefovir 10 mg/day, Entecavir 0.5 mg/day
16315814|NCT00531141|Other|examination only|OCT performed twice
16315815|NCT00531128|Behavioral|High/Low Sitosterol|
16315816|NCT00531115|Drug|cetuximab 5mg/ml|"Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21).
~The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment."
16315817|NCT00531102|Other|continuous positive airway pressure|Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes
16315818|NCT00531102|Other|Free flow oxygen|Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.
16315819|NCT00531089|Drug|Rituximab|Rituximab will be administered on weeks 1, 2, 3, and 4 at a dose of 375 mg/m2 per infusion. Premedications (prednisone 50 mg, diphenhydramine 50 mg, acetaminophen) will be administered prior to study infusion. Patients will also be treated with plasma exchange as per institution/apheresis centre.
16315820|NCT00531076|Biological|bevacizumab|"Intravenous bevacizumab at 7.5mg/kg and 15mg/kg concurrently with thoracic radiotherapy in sequential cohorts.
~In the final dose level, bevacizumab 15mg/kg concurrent with radiation will be followed by maintenance bevacizumab 15mg/kg up to a maximum of 6 cycles"
16315821|NCT00531063|Drug|Everolimus (RAD001)|
16315822|NCT00531050|Drug|Indacaterol|Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).
16315823|NCT00531050|Drug|Placebo|Single dose indacaterol matching placebo via Concept 1 device
16315824|NCT00531050|Drug|Salmeterol|Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.
16315825|NCT00531024|Drug|Bevacizumab|3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
16315826|NCT00531024|Drug|Sodium Chloride|3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals
16315827|NCT00531011|Device|XIENCE V® Everolimus Eluting Coronary Stent System|Coronary artery placement of a drug-eluting stent
16315828|NCT00531011|Device|TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System|Coronary artery placement of a drug-eluting stent
16315829|NCT00530998|Procedure|Transvaginal Appendectomy|The appendix will be removed via an incision in the vagina.
16315830|NCT00530998|Procedure|Transvaginal Cholecystectomy|The gallbladder will be removed via an incision in the vagina.
16315831|NCT00530985|Behavioral|Benefits Counseling|Help deciding whether to work
16315832|NCT00530985|Behavioral|VA Orientation|Orientation to services available at VA
16315833|NCT00530972|Drug|Peginterferon alfa-2a plus ribavirin adjusted to body weight|PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
16315834|NCT00530946|Drug|Amlodipine 2.5mg/Atorvastatin 5mg|Single pill combination, dosed once daily for 8 weeks
16315835|NCT00530946|Drug|Amlodipine 2.5mg/Atorvastatin 10mg|Single pill combination, dosed once daily for 8 weeks
16315836|NCT00530946|Drug|Amlodipine 5mg/Atorvastatin 5mg|Single pill combination, dosed once daily for 8 weeks
16315837|NCT00530946|Drug|Amlodipine 5mg/Atorvastatin 10mg|Single pill combination, dosed once daily for 8 weeks
16315838|NCT00530933|Procedure|Percutaneous posterior tibial nerve stimulation|Once weekly for 30 minutes
16315839|NCT00530933|Procedure|Transcutaneous tibial nerve stimulation|30 minutes once weekly
16315840|NCT00530933|Procedure|Sham transcutaneous tibial nerve stimulation|Once weekly for 30 minutes
16315841|NCT00530920|Drug|tipranavir|
16315842|NCT00530920|Drug|ritonavir|
16315843|NCT00530907|Drug|Valproic Acid|5.3 mg/kg by mouth daily x 28 days
16315844|NCT00530907|Drug|Bevacizumab|2.5 mg/kg by vein over 90 minutes every 2 weeks
16315845|NCT00530894|Device|Edwards SAPIEN Transcatheter Heart Valve|
16315846|NCT00530894|Device|Surgical Valve Replacement|
16315847|NCT00530894|Other|medical management and/or balloon aortic valvuloplasty|
16315848|NCT00530881|Drug|PHX1149|
16315849|NCT00530868|Other|Letrozole (Femara)|Letrozole 2.5 mg PO a day for 24 weeks
16315850|NCT00530868|Drug|Letrozole; Avastin|Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
16315851|NCT00530855|Drug|Lacosamide|50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
16315852|NCT00530842|Drug|Tiotropium plus Salmeterol|
16315853|NCT00530842|Drug|Fluticasone/Salmeterol|
16315854|NCT00530829|Drug|zinc|10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
16315855|NCT00530816|Drug|carfilzomib|Intravenous (IV) injection over 2 to 10 minutes twice weekly for three weeks followed by 12 days of rest.
16315856|NCT00530803|Drug|EMLA Cream|60 minutes x1
16315857|NCT00530803|Combination Product|Synera Patch|20 minutes x1
16315858|NCT00530790|Drug|ropinirole controlled release (CR)-RLS|White film-coated round-shaped tablet
16318389|NCT00511563|Drug|GW876008 and GSK561679|GW876008 and GSK561679
16315860|NCT00530777|Drug|placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
16315861|NCT00530764|Drug|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
16315862|NCT00530764|Drug|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
16315863|NCT00530764|Drug|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
16315864|NCT00530751|Other|counseling intervention|Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool [GREAT]) are explored.
16315865|NCT00530738|Drug|Lipoplus|i.v. fat emulsion for parenteral nutrition
16315866|NCT00530738|Drug|Lipofundin MCT|i.V. fat emulsion for parenteral nutrition
16315867|NCT00530725|Procedure|chest drainage|may be a chest tube of chest drainage procedure of any type (ie formal tube, pig-tail catheter, etc)
16315868|NCT00530725|Other|close clinical observation|close clinical observation in an operating room or intensive care unit without active intervention
16315869|NCT00530712|Device|PROTÉGÉ® EverFlex™ Self-Expanding Stent System|Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
16315870|NCT00530699|Drug|AZD1152|intravenous
16315871|NCT00530686|Drug|Islet cell transplantation|The process is based on the enzymatic isolation of the pancreatic islets of Langerhans from an organ procured from a cadaveric donor; the islets obtained are injected into the liver of the recipient via percutaneous catheterization of the portal venous system . This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity.
16315872|NCT00530660|Biological|H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted|All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.
16315873|NCT00530634|Drug|cisplatin|
16315874|NCT00530634|Drug|gemcitabine hydrochloride|
16315875|NCT00530634|Genetic|gene expression analysis|
16315876|NCT00530634|Genetic|reverse transcriptase-polymerase chain reaction|
16315877|NCT00530634|Other|immunohistochemistry staining method|
16315878|NCT00530634|Procedure|adjuvant therapy|
16315879|NCT00530634|Procedure|conventional surgery|
16315880|NCT00530634|Radiation|radiation therapy|
16315881|NCT00530621|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
16315882|NCT00530621|Drug|placebo|oral, daily
16315883|NCT00530621|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
16315884|NCT00530595|Drug|candesartan or valsartan or losartan|
16315885|NCT00530582|Drug|progesterone|300mg progesterone /placebo each for 21 days
16315886|NCT00530569|Procedure|Blood Test|CBC and HER2 level at baseline, prior to each chemo and/or herceptin cycle, one month after chemo and/or herceptin completion, quarterly up to 12 months or a maximum of 20 blood draws.
16315887|NCT00530556|Drug|zolpidem|
16315888|NCT00530543|Procedure|Robot-assisted gait training|
16315889|NCT00530530|Drug|ASP8825|oral
16315890|NCT00530530|Drug|Placebo|oral
16315891|NCT00530517|Device|Intraject Sumatriptan|needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
16315892|NCT00530504|Device|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device|Carotid artery stenting with distal embolic protection.
16315893|NCT00530491|Procedure|Fast track lung surgery|fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
16315894|NCT00530478|Drug|Donepezil|
16315895|NCT00530452|Drug|CG100649|Dual-acting COX-2 inhibitor & carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
16315896|NCT00530452|Drug|Silicified microcrystalline cellulose + talc|Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.
16315897|NCT00530439|Other|Lifestyle intervention|Dietician counselling and physical training
16315898|NCT00530439|Other|Control|Repeated measuring of maternal weight gain, blood samples and ultrasound
16315899|NCT00530439|Behavioral|Physical activity, dietetic counselling|"The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.
~Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week."
16315900|NCT00530413|Drug|Phenobarbital|Phenobarbital will be given based on weight range
16315901|NCT00530413|Other|Placebo|Placebo group
16315902|NCT00530400|Drug|cefuroxime|preoperative intravenous 1.5g cefuroxime
16315903|NCT00530400|Drug|placebo|preoperative intravenous placebo
16315904|NCT00530387|Drug|19 organic sunscreen filters and 5 topical NSAIDs|
16315905|NCT00530374|Dietary Supplement|Oral Iron Supplement|Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
16315906|NCT00530374|Dietary Supplement|Placebo|Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
16315907|NCT00530361|Drug|Nesiritide|
16315908|NCT00530348|Biological|Alemtuzumab|Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
16315909|NCT00530348|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
16315910|NCT00530335|Drug|Atomoxetine|40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
16315911|NCT00530322|Procedure|Laparoscopy|"A second-look laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy)."
16315912|NCT00530309|Drug|GSK716155 for injection|GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.
16315913|NCT00530309|Drug|Placebo|Subjects will also receive placebo.
16315914|NCT00530296|Behavioral|Cognitive Behavioral Therapy|"Group therapy, 12 sessions (90 minutes each, one session per week) manual Coping with depression course"
16315915|NCT00530283|Other|PET-CT|
16315916|NCT00530270|Drug|Dexamethasone|Individuals meeting entry criteria will be randomized to receive dexamethasone 0.3 mg/kg (12 mg maximum single dose). The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days.
16315917|NCT00530270|Drug|Placebo|Individuals meeting entry criteria will be randomized to receive 0.3 mg/kg (12 mg maximum single dose) of placebo. The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days.
16315918|NCT00530257|Drug|Placebo|Placebo (sugar pill)
16315919|NCT00530257|Drug|OROS-methylphenidate|18 mg to 54 mg once a day for 1 week
16315920|NCT00530244|Dietary Supplement|Docosahexaenoic acid (DHA)|Infant formula with 0.96% of fatty acids as DHA
16315921|NCT00530244|Dietary Supplement|Standard formula (Enfamil)|This is a standard, commercially available infant formula.
16315922|NCT00530218|Drug|Ganciclovir|Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks
16315923|NCT00530205|Other|physiologic testing|
16315924|NCT00530205|Other|questionnaire administration|
16315925|NCT00530205|Procedure|management of therapy complications|
16315926|NCT00530205|Radiation|radiation therapy|
16315927|NCT00530192|Other|Treatment based on Molecular Profiling|Treatment with commercially available treatments (per package insert instructions)
16315928|NCT00530179|Procedure|Autologous Blood Stem Transplantation|2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY AUTOLOGOUS BLOOD STEM CELL TRANSPLANTATION
16315929|NCT00530179|Drug|R-CHOP|6 - 21 DAY Cycles of R-CHOP
16315930|NCT00530166|Drug|JNJ-18054478|3(100 mg) tablets once daily for 12 weeks
16315931|NCT00530166|Drug|sham comparator|3(100 mg) tablets once daily for 12 weeks
16315932|NCT00530153|Behavioral|dietary counseling|Various activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition.
16315933|NCT00530153|Dietary Supplement|xylitol|Delivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing.
16315934|NCT00530140|Biological|Follicular lymphoma, patient-specific, soluble protein idiotype vaccine|0.5 mg of idiotype conjugated to 0.5 mg of KLH + 125 mcg of GM-CSF 5 monthly vaccinations followed by 3 bi-monthly vaccinations, followed by one boost every three months until either relapse or death from cause unrelated to lymphoma
16315935|NCT00530127|Drug|placebo|Same dose and frequency as treatment
16315936|NCT00530127|Drug|deferiprone|100 mg/mL
16315937|NCT00530127|Drug|deferiprone|100 mg/mL
16315938|NCT00530127|Drug|placebo|Same dosage and frequency as study drug
16315939|NCT00530127|Drug|deferiprone|100 mg/mL
16315940|NCT00530114|Drug|AMG 223|1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
16315941|NCT00530114|Drug|Placebo|1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
16315942|NCT00530101|Drug|Doxorubicin|"This pilot study will select patients who are at increased likelihood to develop cardiotoxicity, due to borderline cardiac function at baseline, advanced age, or the anticipation of a high cumulative dose of administered doxorubicin. Patients who will receive radiation therapy to the left chest during chemotherapy (i.e., left breast cancer) will be excluded so as to eliminate possible cardiotoxic effects from radiation. CMR studies will be performed at no charge to the patient, supported by the sponsor of this study. CMR imaging will be subject to IRB approval, informed consent, and HIPAA regulations. Contrast-enhanced CMR will be obtained at three time points:
~Patients will not undergo contrast-enhanced MR unless calculated GFR is equal to or greater than 60 mL/min/1.73 m2"
16315943|NCT00530088|Drug|porfimer sodium|IV
16315944|NCT00530088|Drug|Photdynamic Therapy (PDT)|
16315945|NCT00530075|Drug|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles
16315946|NCT00530062|Drug|Albuterol-HFA-MDI|Inhalation Aerosols, 90 mcg, 1 dose per treatment period
16315947|NCT00530062|Drug|Albuterol-HFA-BAI|Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
16315948|NCT00530049|Other|questionnaire administration|
16315949|NCT00530049|Procedure|assessment of therapy complications|
16315950|NCT00530049|Procedure|psychosocial assessment and care|
16315951|NCT00530049|Procedure|quality-of-life assessment|
16315952|NCT00530023|Device|MiniMed Paradigm REAL-Time System|MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
16315953|NCT00530010|Radiation|yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.
16315954|NCT00529997|Device|Stabilimax NZ® Dynamic Spine Stabilization System|Surgical Implantation
16315955|NCT00529984|Biological|AVX701|4 doses of AVX701 at 4e7 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
16315956|NCT00529984|Biological|AVX701|4 doses of AVX701 at 1e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
16315957|NCT00529984|Biological|AVX701|4 doses of AVX701 at 4e8 IU given at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
16315958|NCT00529984|Biological|AVX701|4 doses of AVX701 given at the maximally tolerated dose at T=0, 3, 6, 9 weeks. Option for subjects to receive additional immunizations every 3 months after the 4th immunization if no dose-limiting toxicities or is without progressive disease
16315959|NCT00529984|Biological|AVX701|4 Doses of AVX701 given to Stage III colon cancer subjects at the maximally tolerated dose at T=0, 3, 6, 9 weeks. There will be no option for subjects to receive additional immunizations.
16315960|NCT00529971|Behavioral|MBSR group|8-week MBSR group, 3 hours per week plus one all day retreat
16315961|NCT00529971|Other|Control|Treatment as usual, which could include medications or psychotherapy
16315962|NCT00529958|Procedure|Patellar Tendon|Patellar Tendon autograft
16315963|NCT00529958|Procedure|Hamstring Tendon|Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
16315964|NCT00529958|Procedure|Double-Bundle|Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
16315965|NCT00529945|Device|PFx Closure System|
16315966|NCT00529932|Other|CD133+ infusion|Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
16315967|NCT00529932|Other|placebo infusion|Buffered normal saline will be infused in the coronary artery during an angiography.
16315968|NCT00529919|Dietary Supplement|Weight loss|Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil
16315969|NCT00529880|Drug|Fludarabine , cytarabine|
16315970|NCT00529867|Drug|Artemether/lumefantrine tablets|"Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine
~Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets
~Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2"
16315971|NCT00529867|Drug|Artemether/Lumefantrine suspension|"Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension
~Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml
~Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2"
16315972|NCT00529854|Other|SIC-IR Billing Module|Medical informatic application designed to help with billing and documentation within the surgical and trauma intensive care unit
16315973|NCT00529841|Drug|Hydrocortisone sodium acetate|Subcutaneous administration of medication via insulin pump
16315974|NCT00529828|Procedure|Consumption of CLA enriched food|
16315975|NCT00529815|Device|Continuous Glucose Monitor|The intervention group will alternate the use of the CGM with episodic self blood glucose monitoring for four cycles of two weeks using the CGM and episodic SBGM and one week only using episodic SBGM during the 12 week study.
16315976|NCT00529815|Device|Glucometer|The control group (SBGM) will be instructed in the use of the Accuchek Aviva glucometer.
16315977|NCT00529802|Drug|RAD001|take 2 tablets of RAD001 once a day by mouth (10 mg per day)
16315978|NCT00529789|Drug|duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
16315979|NCT00529776|Procedure|Continuous lateral rotation therapy|
16315980|NCT00529763|Drug|Dasatinib|Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
16315981|NCT00529750|Drug|IRBESARTAN|Tablets
16315982|NCT00529750|Drug|Atenolol|Tablets
16315983|NCT00529737|Procedure|Breast Biopsy|Stereotactic-guided breast biopsy via standard practice of care
16315984|NCT00529737|Procedure|Post Procedure Mammogram|View of post-procedure mammogram same projection as used in the biopsy procedure (View A), and mammographic view orthogonal projection to the first view (View B).
16315985|NCT00529724|Behavioral|Energy metabolism by chronic bilateral subthalamic stimulation|Patients will be studied before and after STN-DBS surgery
16315986|NCT00529711|Drug|Hypertonic lactate|"Solution given parenterally as follows:
~Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours."
16315987|NCT00529711|Drug|Ringer's lactate|"Solution given parenterally as follows:
~Intraoperative 3 ml./kg BW for 15 minutes at beginning of surgery; During surgery 1.5 ml/kg BW/hour; Second loading 1.5 ml/kg BW for 15 minutes after protamin administration; Post-operative 1 ml/kg BW/hour for 12 hours."
16315988|NCT00529698|Biological|Biologically active recombinant Tat protein|
16315989|NCT00529672|Procedure|crossectomy and short stripping|under spinal or complete anaesthesia
16315990|NCT00529672|Procedure|ultrasound guided sclerotherapy with foam|1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
16315991|NCT00529672|Procedure|endovenous laser therapy|940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.
16315992|NCT00529659|Drug|Comparator: MK-0773|MK-0773 50 mg tablets twice daily, 6 month treatment period
16315993|NCT00529659|Drug|Comparator: Placebo|Placebo tablets twice daily, 6 month treatment period
16315994|NCT00529646|Drug|APD791|
16315995|NCT00529633|Drug|Thalidomide|Thalidomide by mouth at night for a total of 24 weeks
16315996|NCT00529633|Other|Sugar pill|Placebo by mouth at night for a total of 24 weeks
16315997|NCT00529620|Drug|sulfalene-pyrimethamine plus amodiaquine|Monthly treatments during the malaria transmission season
16315998|NCT00529620|Drug|dihydroartemisinin plus piperaquine|Monthly treatments during the transmission season
16315999|NCT00529620|Drug|sulfadoxine pyrimethamine plus piperaquine|Monthly treatments during the malaria transmission season
16316000|NCT00529607|Drug|contrast echocardiography|directly after PCI, at 24 h after PCI, before discharge and at 6 months
16316001|NCT00529607|Procedure|2D and 3D echocardiography|directly after PCI, at 24 h after PCI, before discharge and at 6 months
16316002|NCT00529607|Procedure|cardiac MRI|before discharge and after 6 months
16316003|NCT00529607|Procedure|blood sampling|"routine lab work plus infarction and inflammation biomarkers
~1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3"
16316004|NCT00529594|Drug|placebo (Control Group)|Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
16316005|NCT00529594|Drug|Etoricoxib (Treatment Group)|Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation
16316006|NCT00529581|Drug|C105|
16316007|NCT00529568|Drug|eltrombopag|double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg
16316008|NCT00529568|Drug|placebo|double-blind matched placebo control daily oral administration
16316009|NCT00529555|Drug|minocycline HCl 2.1%|Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
16316010|NCT00529555|Procedure|Scaling and root planing|scaling and root planing
16316011|NCT00529542|Drug|Lipitor|40mg caplets per day for six weeks
16316012|NCT00529542|Drug|Placebo|1 placebo caplet per day for six weeks.
16316013|NCT00529529|Drug|Indacaterol 300 μg|Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
16316014|NCT00529529|Drug|Salmeterol 50 μg|Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
16316015|NCT00529529|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
16316016|NCT00529529|Drug|Placebo to salmeterol|Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
16316017|NCT00529516|Biological|Fluarix|Single dose, Intramuscular injection
16316018|NCT00529516|Biological|GSK Biologicals Influenza Vaccine GSK576389A|Single dose, Intramuscular injection
16316019|NCT00529503|Drug|SGN-40|2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
16316020|NCT00529503|Drug|placebo|Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
16316021|NCT00529503|Drug|rituximab|375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
16316022|NCT00529503|Drug|etoposide|100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
16316023|NCT00529503|Drug|carboplatin|AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
16316024|NCT00529503|Drug|ifosfamide|5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
16316025|NCT00529490|Drug|Hypertonic lactate|Parenteral solution administered to a maximal volume of 10 ml/kg BW over the first 12 hours post-CABG
16316026|NCT00529490|Drug|Ringer's lactate|Parenteral solution administered to a maximal dose of 30 ml/kg BW over the first 12 hours post-CABG
16316027|NCT00529477|Other|1. Wright Nebulizer|The Wright nebulizer will be used to perform the methacholine challenge.
16316028|NCT00529477|Other|Pari LC Nebulizer|The Pari LC nebulizer will be used to perform the methacholine challenge.
16316029|NCT00529477|Other|The Pari Sinustar Nebulizer|The Pari Sinustar nebulizer will be used to perform the methacholine challenge.
16316030|NCT00529464|Procedure|Fluorescence Spectroscopy|Pictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue.
16316031|NCT00529464|Procedure|Colposcopy|A standard colposcopy will be performed.
16316032|NCT00529464|Procedure|LEEP Procedure|A small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam.
16316033|NCT00529451|Drug|Aliskiren|Aliskiren
16316034|NCT00529451|Drug|Ramipril|comparator
16316035|NCT00529438|Drug|Bardoxolone methyl|
16316036|NCT00529425|Drug|Ropivacaine|
16316037|NCT00529412|Other|Seprafilm|two sheets per body
16316038|NCT00529399|Drug|GAD-Alum|Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
16316039|NCT00529399|Drug|GAD-Alum and Aluminum hydroxide|Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
16316040|NCT00529399|Drug|Aluminum hydroxide|Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
16316041|NCT00529386|Drug|Botox|300 units
16316042|NCT00529373|Drug|Odanacatib|50 mg tablet orally once weekly (OW)
16316043|NCT00529373|Drug|Placebo for Odanacatib|50 mg tablet orally OW
16316044|NCT00529373|Dietary Supplement|Vitamin D3|5600 IU orally OW
16316045|NCT00529373|Dietary Supplement|Calcium carbonate|If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg
16316046|NCT00529360|Drug|Clofarabine|Dose escalation of clofarabine on Days -9, -8, -7, -6, -5: 1 - 30 mg/m2; 2 - 40 mg/m2; 2 - 46 mg/m2; 3 - 52 mg/m2
16316047|NCT00529360|Drug|Clofarabine|Use dose of clofarabine established in Part A to further define event free, disease free and overall survival.
16316048|NCT00529347|Device|neurally adjusted ventilatory assist (NAVA)|assessment of breathing pattern at various ventilator settings
16316131|NCT00528762|Behavioral|Focus Group|Focus group discussion about puberty and body image lasting 1 1/2 hours.
16318930|NCT00507533|Procedure|Continuous positive airway pressure|
16316049|NCT00529334|Radiation|CyberKnife Partial Breast Irradiation|Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
16316050|NCT00529321|Biological|MVA-HCV (Immunotherapy)|MVA-HCV
16316051|NCT00529308|Device|Transcranial Magnetic Stimulation (active)|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
16316052|NCT00529308|Device|Transcranial Magnetic Stimulation (sham)|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
16316053|NCT00529295|Drug|misoprostol|Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
16316054|NCT00529282|Drug|Ceftobiprole Medocaril|500 mg every 8 hours
16316055|NCT00529282|Drug|Cefepime with or without vancomycin|120-minute infusion [250 mL]
16316056|NCT00529269|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16316057|NCT00529256|Behavioral|Feeback group|The intervention practices received a quarterly comparative feedback performance report based on the Achievable Benchmarks of Care (ABC) research conducted by Kieffe (YEAR).
16316058|NCT00529243|Drug|raltegravir|This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
16316059|NCT00529230|Behavioral|Questionnaire|A set of questionnaires regarding sexual function, physical and psychological symptoms.
16316060|NCT00529230|Other|Blood draws to assess gonadal function|Testosterone, FSH, and LH levels at study onset.
16316061|NCT00529217|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
16316062|NCT00529204|Drug|exenatide|Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24
16316063|NCT00529191|Drug|Atorvastatin|Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months
16316064|NCT00529191|Other|Placebo|One out of three subjects will receive a placebo.
16316065|NCT00529178|Drug|Pravastatin|
16316066|NCT00529165|Procedure|injection-meal-interval|"The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
~Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
~Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
~Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks."
16316067|NCT00529152|Drug|Deferiprone|Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks.
16316068|NCT00529139|Device|Standard extended dialysis|Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
16316069|NCT00529139|Device|Intensified extended dialysis|Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)
16316070|NCT00529126|Drug|SKY0402|SKY0402
16316071|NCT00529126|Drug|Bupivacaine HCl|Bupivacaine HCl
16316072|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (150 mg/day) for 21 days
16316073|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (300 mg/day) for 21 days
16316074|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (150 mg/day) for 28 days
16316075|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (200 mg/day) for 28 days
16316076|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (250 mg/day) for 28 days
16316077|NCT00529113|Drug|Bardoxolone methyl|Bardoxlone methyl capsules (300 mg/day) x 28 days
16316078|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl capsules (350 mg/day) x 28 days
16316079|NCT00529113|Drug|Gemcitabine|1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
16316080|NCT00529113|Drug|Placebo|Placebo capsules x 28 days
16316081|NCT00529113|Drug|Bardoxolone methyl|Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
16316082|NCT00529100|Drug|Pemetrexed Phase 1|300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles
16316083|NCT00529100|Drug|Cisplatin Phase 1|"Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles
~Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles."
16316084|NCT00529100|Procedure|Radiation Therapy|Phases 1 and 2: 61-65 Gy in 33-35 fractions
16316085|NCT00529100|Drug|Pemetrexed Phase 2|Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
16316086|NCT00529100|Drug|Cisplatin Phase 2|Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.
16316087|NCT00529087|Drug|N-methylnaltrexone bromide (MOA-728)|Subcutaneous
16316088|NCT00529087|Other|placebo|placebo
16316132|NCT00528749|Other|Patient will wear ARES device while undergoing sleep study|Device is worn on forehead
16316133|NCT00528723|Drug|salbutamol 100 mcg|To be used as needed for symptom relief
16316134|NCT00528723|Drug|BDP/salbutamol HFA pMDI|Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo
16316180|NCT00528411|Drug|Ticagrelor Tablets|Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
16318931|NCT00507520|Procedure|Full dose almonds|
16316089|NCT00529074|Device|Epidural Catheter for Analgesia|Patients enrolled will be placed into one of two groups of 30 patients. The decision to place the patients in either one of the two groups will be randomized as above. The Epidural group will have a thoracic epidural catheter placed pre-operatively at the T6-T7 level before general anesthesia is given. (using a .1% Marcaine and .1% Meperidine solution) A dose of Ketorolac will be given 15 minutes before the patient will be awakened from anesthesia (provided that there is good renal function and the patient is not hypovolemic) The catheter will be used preoperatively as an adjunct for general anesthesia as well as used postoperatively for continuous epidural analgesia(CEA). The control group will be given general anesthesia alone and post-operative PCA along with NSAIDS before leaving for the recovery room (as above).
16316090|NCT00529048|Other|Oral Glucose Tolerance Test|The test is preformed 3 times with 3 different amounts of glucose (25g, 75g and 125g) deluded in 300ml of water.
16316091|NCT00529048|Other|Isoglycemic clamp|I.v. glucose infusion initiating the glucose responds curves from the OGTT
16316092|NCT00529048|Other|Gastric emptying rate|Paracetamol absorption test. Intake of 1,5g of paracetamol followed by measuring the absorption curve
16316093|NCT00529035|Drug|Interleukin-2|Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.
16316094|NCT00529022|Drug|Azacitidine|75 mg/m^2 Subcutaneous Injection or by vein Daily for 5 Days.
16316095|NCT00529022|Drug|Valproic Acid|40 mg/kg by mouth Daily for 7 days.
16316096|NCT00529022|Drug|Carboplatin|AUC 2 by vein on Days 3 and 10 over 60 Minutes.
16316097|NCT00529009|Drug|UDCA|
16316098|NCT00528996|Drug|BEA 2180 BR|Solution
16316099|NCT00528996|Drug|Tiotropium Bromide|Solution
16316100|NCT00528996|Drug|Placebo|Solution
16316101|NCT00528983|Drug|Subcutaneous (SC) Azacitidine|75 mg/day for first 7 days of 28 day cycle for 1 cycle only.
16316102|NCT00528983|Drug|Oral Azacitidine|Cycle 2 and beyond starting dose of 120 mg/day for first 7 days of 28 day cycle. Dose will escalate in increments of 60 mg. Following evaluation dose escalation will occur in 120 mg increments until maximum tolerated dose (MTD) is reached.
16316103|NCT00528983|Drug|Oral Azacitidine|Starting dose for 14 day-QD treatment schedule will be 300 mg/day. Starting dose for 14 day-BID, 21 day-QD, 21 day-BID treatment schedules will be 100 mg, 200mg, 300mg. Dose will escalate in increments of 100 mg until MTD is reached.
16316104|NCT00528970|Drug|MOA-728|MOA-728 will be administered per the dose and schedule specified in the arm.
16316105|NCT00528970|Drug|Placebo|Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
16316106|NCT00528957|Drug|Tenofovir DF|Tenofovir DF (oral powder or tablet): 300-mg tablets for participants > 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to > 37 kg may be switched from the oral powder to the tenofovir DF tablet.
16316107|NCT00528957|Drug|Zidovudine|Zidovudine as prescribed by the investigator prior to study entry (pediatric participants < 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).
16316108|NCT00528957|Drug|Stavudine|Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m^2 every 8 hours; pediatric participants > 12 years of age: 300 mg twice daily).
16316109|NCT00528931|Biological|collagenase clostridium histolyticum|Single dose of AA4500 0.58 mg into the cord
16316110|NCT00528918|Drug|Glulisine (Apidra)|An algorithm to determine the initial doses of insulin and dose adjustments is as follows: Lean subjects (BMI less than 25 kg/m2) will initially receive a total of 0.4 units/kg/day, overweight subjects (BMI 25-30 kg/m2) 0.5 units/kg/day and obese subjects (BMI greater than 30 kg/m2) 0.6 units/kg/day. Fifty percent of the total amount of insulin will be given as Glargine and 50% as regular insulin or Apidra. Supplemental short-acting insulin will be given for hyperglycemia before meals. Automated order sets shall be generated to minimize errors in order entries. Glucose concentrations will be measured before each meal and at bedtime, and if symptomatic. In addition, eight-point blood glucose profiles will be obtained every three days starting on day 2. Dose adjustments will be made to keep blood glucose concentrations between 80 and 120 mg/dl pre-prandially and less than180 mg/dl after meals.
16316111|NCT00528905|Drug|AZD3480|oral capsule
16316112|NCT00528892|Drug|Raltegravir|switching PI to raltegravir
16316113|NCT00528892|Drug|boosted PI|continue on boosted-PI
16316114|NCT00528879|Drug|Dapagliflozin|Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
16316115|NCT00528879|Drug|Placebo|Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
16316116|NCT00528879|Drug|Metformin|Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
16316117|NCT00528866|Drug|bicalutamide|50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration
16316118|NCT00528866|Drug|docetaxel|75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy
16316119|NCT00528866|Drug|flutamide|250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration
16316120|NCT00528866|Drug|LHRH agonist|LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration
16316121|NCT00528866|Radiation|3-dimensional conformal radiation therapy|
16316122|NCT00528866|Radiation|radiation therapy|66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones
16316123|NCT00528840|Biological|collagenase clostridium histolyticum|Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
16316124|NCT00528827|Drug|Cardene® I.V.|"5 mcg/kg/min Cardene I.V.
~2.5 mcg/kg/min Cardene I.V.
~0.5 mcg/kg/min Cardene I.V."
16316125|NCT00528814|Other|Active Hand Sanitizer|Active Hand Sanitizer
16316126|NCT00528801|Behavioral|NP Battery|Neuropsych Battery with 7 different tests that evaluate the patients neurological functioning.
16316127|NCT00528801|Procedure|MRI|The MRI is a standard procedure involving 30 minutes under the machine in order to obtain various images of the patients brain.
16316128|NCT00528788|Drug|doxercalciferol|
16316129|NCT00528775|Drug|HPPH|4 mg/m2 IV
16316130|NCT00528775|Procedure|endoscopic procedure|Treatment with 150 joules from laser
16316135|NCT00528723|Drug|BDP/salbutamol CFC pMDI|Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo
16316136|NCT00528710|Dietary Supplement|SAM-e (S-Adenosyl-L-Methionine)|One 400 mg tablet daily in the morning.
16316137|NCT00528697|Drug|ABT-089|Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
16316138|NCT00528697|Drug|atomoxetine|Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
16316139|NCT00528697|Drug|placebo|Subject will take a tablet once daily for 8 weeks
16316140|NCT00528684|Biological|REOLYSIN®|REOLYSIN® is administered as a single intratumoral infusion over 72 hours. Dose levels in Phase 1 will be 1x10E8, 3x10E8, 1x10E9, 3x10E9, 1x10E10 TCID50. The dose level for Phase 2 will be the top dose reached in Phase 1.
16316141|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.8 - 2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients, INR-self management once a week
16316142|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management once a week
16316143|NCT00528671|Drug|phenprocoumon|The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management twice a week
16316144|NCT00528658|Drug|Paracetamol|1g qid
16316145|NCT00528658|Drug|Ibuprofen|400mg tid
16316146|NCT00528658|Drug|Paracetamol Placebo|equivalent to 1g qid
16316147|NCT00528658|Drug|Ibuprofen placebo|Equivalent to 400mg tid
16316148|NCT00528645|Drug|saracatinib|Given orally
16316149|NCT00528632|Other|Specimen biopsy and serum laboratory tests|"Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy
~Laboratory tests measuring levels of plasma total cholesterol and triglycerides"
16316150|NCT00528619|Drug|Sunitinib, Pemetrexed, Cisplatin, Carboplatin|Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.
16316151|NCT00528606|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
16316152|NCT00528606|Biological|Placebo|Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
16316153|NCT00528593|Drug|epoetin alfa|Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
16316154|NCT00528580|Drug|Simvastatin|80 mg once daily PO/NG x 4 days
16316155|NCT00528580|Drug|Identical-appearing placebo|once daily x 4 days
16316156|NCT00528567|Drug|Bevacizumab|Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
16316157|NCT00528567|Drug|Standard adjuvant chemotherapy|All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
16316158|NCT00528554|Procedure|laser acupuncture|laser acupuncture according to traditional chinese medicine criteria, energy dosage 1J/point, average of 8 points to be treated, once daily during chemotherapy course
16316159|NCT00528554|Procedure|placebo laser acupuncture|laser acupuncture according to traditional chinese medicine criteria, average of 8 points to be treated, once daily during chemotherapy course
16316160|NCT00528541|Biological|botulinum toxin type A|200 Units at Visit 1 (Day 1)
16316161|NCT00528541|Biological|botulinum toxin type A|750 Units at Visit 1 (Day 1)
16316162|NCT00528528|Drug|Telaprevir|Oval tablets containing 375 mg of telaprevir for oral administration.
16316163|NCT00528528|Drug|Peg-IFN-alfa-2a|Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.
16316164|NCT00528528|Drug|Peg-IFN-alfa-2b|Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.
16316165|NCT00528528|Drug|Ribavirin (RBV) tablet|Tablets containing 200 mg RBV for oral administration.
16316166|NCT00528528|Drug|Ribavirin (RBV) capsule|Capsules containing 200 mg RBV for oral administration.
16316167|NCT00528515|Drug|Diprivan (propofol), Astra-Zeneca|continuous intravenous infusion with a dose of 3-5 mg/kg/h
16316168|NCT00528515|Drug|Suprane (desflurane), Baxter|a vapor concentration of 3-7 vol% is maintained with use of vaporizer and under control of arterial blood pressure, heart rate, and BIS index.
16316169|NCT00528502|Drug|Lidocaine|Lidocaine is misted into the air that you breathe during the surgery.
16316170|NCT00528502|Drug|Saline|Saline is misted into the air that you breathe during the surgery.
16316171|NCT00528489|Biological|PennVax B|DNA vaccine containing the HIV genes Gag, Pol, and Env
16316172|NCT00528489|Biological|IL-12|Cytokine injection
16316173|NCT00528489|Biological|IL-15|Cytokine injection
16316174|NCT00528463|Procedure|sciatic nerve block|Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op
16316175|NCT00528450|Drug|arsenic trioxide|
16316176|NCT00528450|Drug|idarubicin|
16316177|NCT00528450|Drug|tretinoin|
16316178|NCT00528437|Drug|temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid|13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
16316179|NCT00528424|Biological|AA4500|Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.
16316181|NCT00528411|Drug|Clopidogrel (over encapsulated) capsule|Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
16316182|NCT00528411|Drug|Aspirin Tablets|Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
16316183|NCT00528398|Drug|cytarabine|
16316184|NCT00528398|Drug|idarubicin|
16316185|NCT00528385|Drug|Spironolactone (Spironol) 25 mg|In the 8-weeks run-in period ACEI, cilazapril (5 mg), telmisartan (80 mg) and hydrochlorotiazyd (12.5 mg) were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 25 mg of spironolactone in two active treatment periods lasting 8 weeks each.
16316186|NCT00528372|Drug|Dapagliflozin|Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
16316187|NCT00528372|Drug|Dapagliflozin placebo|Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks
16316188|NCT00528372|Drug|Metformin|
16316189|NCT00528359|Drug|quetiapine or olanzapine or risperidone or aripiprazole|
16316190|NCT00528346|Behavioral|cognitive training using fMRI|Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity.
16316191|NCT00528346|Behavioral|placebo|Some participants will see simulated data that does not come from their own brains.
16316192|NCT00528333|Drug|Lintuzumab (SGN-33)|600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.
16316193|NCT00528333|Drug|Low dose cytarabine|20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
16316194|NCT00528333|Drug|Placebo|IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles
16316195|NCT00528320|Device|Ovatio CRT|
16316196|NCT00528307|Device|HIS buldle ablation|HIS bundle ablation, followed by implant of a biventricular pacemaker
16316197|NCT00528294|Radiation|GRID radiotherapy|GRID-radiotherapy followed by biological imaging guided IMRT
16316198|NCT00528281|Drug|Lapatinib|Lapatinib was administered once daily orally. Patients will begin treatment at Dose Level 0, using a lower dose of pemetrexed, 400mg (approved dose is 500mg). Absent a DLT or need for treatment delay in cycle 1, Dose level 0 or 1, patients may be dose escalated to dose level 1 or 2, respectively in cycle 2.
16316199|NCT00528281|Drug|Pemetrexed|Pemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg.
16316200|NCT00528268|Drug|Sodium phenylbutyrate (NaPB)|The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months.
16316201|NCT00528255|Drug|Misoprostol Vaginal Insert (MVI 100)|The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.
16316202|NCT00528242|Drug|SLx-2101|
16316203|NCT00528242|Drug|Placebo|
16316204|NCT00528229|Radiation|Computer Tomography|
16316205|NCT00528216|Drug|Capsaicin Dermal Liquid|
16316206|NCT00528190|Drug|Itraconazole|Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
16316207|NCT00528177|Drug|Morphine and oxycodone|"At the end of surgery, group 1 will receive intravenous morphine 0.07 mg/kg and intravenous PCA morphine 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. Group 2 will receive intravenous oxycodone 0.07 mg/kg and intravenous PCA oxycodone 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours.
~The patients will use the PCA until the next morning."
16316208|NCT00528164|Behavioral|Team PLAY|Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home. The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
16316209|NCT00528151|Drug|curcumin|curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.
16316210|NCT00528138|Other|Laboratory Test|CRP, white blood cell count, hepatic function tests
16316211|NCT00528125|Procedure|active laser acupuncture|low level laser acupuncture, 830 nm, 30 mW, 0,3 J per acupoint, 2 points per neonate (Hegu and Shen Men). Overall 30 seconds of treatment
16316212|NCT00528125|Procedure|placebo laser acupuncture|placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.
16316213|NCT00528112|Drug|LCS12|Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
16316214|NCT00528112|Drug|LCS16|Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
16316215|NCT00528099|Drug|IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
16316216|NCT00528073|Drug|Rifaximin-EIR|Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease
16316217|NCT00528060|Drug|Atazanavir|2pills/day
16316218|NCT00528060|Drug|Ritonavir|1 pill/day
16316219|NCT00528060|Drug|Tenofovir/emtricitabine|1 pill/day
16316220|NCT00528047|Drug|PRLX 93936|PRLX 93936 will be administered intravenously over one hour daily for 5 days.
16316221|NCT00528034|Procedure|Lymphoscintigraphy|Procedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy.
16316222|NCT00528021|Drug|Placebo|Vehicle Only
16316223|NCT00528021|Drug|BGC20-0582|BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.
16316224|NCT00528008|Other|povidone-iodine solution|Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.
16316555|NCT00525694|Other|Diet Coke|10 ounces of Diet Coke
16316225|NCT00528008|Other|chlorhexidine gluconate|Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
16316226|NCT00527995|Drug|Sildenafil|Orally administered, Sildenafil 100mg, unique administration
16316227|NCT00527982|Drug|Celecoxib|600 mg by mouth daily for a total of 12 months.
16316228|NCT00527969|Drug|HT1001 extract of Panax quinquefolius L|
16316229|NCT00527943|Drug|Vorapaxar|oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
16316230|NCT00527943|Drug|Placebo|oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year
16316231|NCT00527930|Drug|TS-1 and Eloxatin|"S-1 80 mg/m2/day on day 1-14 Oxaliplatin 130 mg/m2 IV for 2 hour on day 1 Every 3 week
~Number of Cycles: until progression or unacceptable toxicity"
16316232|NCT00527917|Device|placebo|bladder instillation
16316233|NCT00527917|Device|Uracyst|20 ml sterile solution for weekly intravesical instillation
16316234|NCT00527904|Drug|PN400 (VIMOVO)|Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.
16316235|NCT00527904|Drug|PN 400 (VIMOVO)|500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months
16316236|NCT00527891|Procedure|Signa Excite 3.0 T MRI Scan|Signa Excite 3.0 T MRI scan within a two week period from the date of receiving standard 1.5 T MR of the liver area.
16316237|NCT00527878|Drug|Ranitidine|Double blinded, randomized placebo controlled crossover study. Patients received 12 months of placebo and 12 months of treatment medication (ranitidine).
16316238|NCT00527878|Drug|Placebo|
16316239|NCT00527865|Drug|DAS181|DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
16316240|NCT00527865|Drug|Placebo|Capsules containing 10.5 mg of lactose will be supplied as placebo.
16316241|NCT00527852|Device|Flocked swab|
16316242|NCT00527826|Drug|Salmeterol / Fluticasone (50/500 µg) BID fixed combination|comparator
16316243|NCT00527826|Drug|Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers|comparator
16316244|NCT00527813|Procedure|prone position|prone position for at least 16 hours per day
16316245|NCT00527800|Drug|Dihydroartemisinin-piperaquine|Once daily for 3 days, given in fixed dose tablets (40 mg dihydroartemisinin + 320 mg piperaquine) according to weight-based guidelines
16316246|NCT00527800|Drug|Artemether-lumefantrine|Dosed twice daily for 3 days, given in fixed dose tablets (20 mg artemether + 120 mg lumefantrine) according to weight-based guidelines
16316247|NCT00527800|Drug|Trimethoprim-sulfamethoxazole|Once daily dosing according to weight based guidelines
16316248|NCT00527787|Drug|PN400 (VIMOVO)|PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
16316249|NCT00527787|Drug|Naproxen|Naproxen (500 mg) dosed twice daily (bid) orally
16316250|NCT00527761|Drug|Cisplatin|20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.
16316251|NCT00527761|Drug|Docetaxel|Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).
16316252|NCT00527761|Drug|Temodar|150 mg by mouth (PO) on Days 1 - 5.
16316253|NCT00527748|Device|Non-Measuring Ankle Exerciser|Stretching exercise performed 10 times per day, for six (6) weeks.
16316254|NCT00527735|Drug|Ipilimumab|Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
16316255|NCT00527735|Drug|Placebo|Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
16316256|NCT00527735|Drug|Paclitaxel|175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
16316257|NCT00527735|Drug|Carboplatin|Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
16316258|NCT00527722|Device|Bio-Seal Track Plug|The lung plug will be inserted into the left track when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.
16316259|NCT00527722|Other|No lung plug|Standard lung biopsy without placement of the plug.
16316260|NCT00527696|Procedure|transvaginal obturator tape|
16316261|NCT00527683|Drug|Vigabatrin|crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks
16316262|NCT00527683|Drug|Placebo|orange juice is administered twice daily in containers indistinguishable from the treatment arm.
16316263|NCT00527683|Behavioral|Group therapy|Participants attend group sessions once a week
16316264|NCT00527670|Procedure|Normal Controls|The control group will have small slivers of tissue removed from the skin and abdomen during surgery to compare genomic information.
16316265|NCT00527670|Procedure|Recurrent Hernia|This group will have small slivers of tissue removed from the skin and abdomen during hernia repair surgery to find genetic proof of hernias being inherited.
16316266|NCT00527657|Drug|Lomustine|Starting dose 30 mg/m^2 by mouth daily on Day 1 and 29.
16316267|NCT00527657|Drug|Temozolomide|75 mg/m^2 by mouth daily on Days 1 to 42.
16316268|NCT00527657|Drug|Thalidomide|200 mg/m^2 by mouth daily.
16316269|NCT00527644|Device|5mm spring clip|Microline Pentax 5mm Visu-Loc Clip Applier
16316270|NCT00527631|Radiation|whole abdomen irradiation using IMRT|Whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions
16316271|NCT00527618|Drug|valacyclovir|valacyclovir 1000 mg orally twice daily for 12 weeks.
16316272|NCT00527618|Drug|acyclovir|acyclovir 400 mg orally twice daily for 12 weeks.
16316273|NCT00527605|Drug|Dutasteride 0.5mg capsule|Dutasteride 0.5mg once daily orally
16316274|NCT00527605|Drug|Dutasteride matched placebo|Dutasteride matched placebo once daily orally
16316275|NCT00527592|Drug|Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
16316276|NCT00527592|Drug|Latanoprost ophthalmic solution 0.005% (XALATAN®)|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
16316277|NCT00527579|Drug|[F-18]FBR|
16316278|NCT00527566|Biological|Mepolizumab|IV mepolizumab, 750 mg
16316279|NCT00527553|Dietary Supplement|not enriched egg|daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin
16316280|NCT00527553|Dietary Supplement|lutein|daily lutein enriched egg
16316281|NCT00527553|Dietary Supplement|zeaxanthin|daily zeaxanthin enriched egg
16316282|NCT00527553|Dietary Supplement|egg product from enriched eggs|daily egg product from lutein enriched eggs
16316283|NCT00527540|Drug|Pegylated Interferon alpha 2a + Ribavirin|Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
16316284|NCT00527527|Procedure|flexion distraction|Chiropractic treatment using the flexion distraction apparatus
16316285|NCT00527527|Other|placebo control|Placebo for comparison with flexion distraction treatment
16316286|NCT00527514|Drug|Amlodipine|Tablets
16316287|NCT00527514|Drug|Olmesartan medoxomil plus amlodipine|Tablets
16316288|NCT00527501|Drug|Travoprost/brinzolamide|
16316289|NCT00527488|Drug|Degarelix|Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
16316290|NCT00527488|Drug|Degarelix|One dose of 32 mg administered as a single administration will be evaluated for 42 days.
16316291|NCT00527488|Drug|Degarelix|Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
16316292|NCT00527488|Drug|Degarelix|One dose of 64 mg administered as a single administration will be evaluated for 42 days.
16316293|NCT00527475|Drug|ranibizumab|0.5 mg. given as an intraocular injection
16316294|NCT00527475|Drug|verteporfin|Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
16316295|NCT00527462|Procedure|Bronchoscopy|bronchoscopy with segmental allergen challenge
16316296|NCT00527462|Other|Exposure to ultrafine carbon black particles|Exposure to ultrafine carbon black particles for 2 hours
16316297|NCT00527449|Drug|Epirubicin, Carboplatin, Docetaxel|75 mg/m² Docetaxel (60 minutes i.v.) and 90 mg/m² Epirubicin (10-15 min i.v.) on day 1, 22, 42. After these 3 cycles 75 mg/m² Docetaxel (60 minutes i.v.) and Carboplatin AUC 5 (30 min i. v.) on day 63, 84, 105.
16316298|NCT00527436|Dietary Supplement|fish oil|Fish oil pills will be taken daily for 12 weeks
16316299|NCT00527436|Dietary Supplement|Placebo|Placebo (corn oil) will be taken daily for 12 weeks
16316300|NCT00527423|Drug|VEGF Trap Eye|Intravitreal injection
16316301|NCT00527410|Drug|RTA 744|Aqueous solution of RTA 744 is packaged in 5 ml vials - 1 mg/ ml. The drug is mixed in D10W and infused over 2 hours on three consecutive days.
16316302|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
16316303|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
16316304|NCT00527397|Drug|CP-464,005|Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose:adjusted based on the results of self-monitoring of blood glucose before each meal.
16316305|NCT00527371|Device|GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]|Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007.
16316306|NCT00527371|Procedure|Transurethral resection of the prostate|Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.
16316307|NCT00527358|Behavioral|SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)|"community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;
~youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence;
~school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;
~Youth drop-in center will provide youth with an adult supervised place to hang out, do homework, or participate in sports and job training."
16316308|NCT00527332|Drug|Bupivacain|5 mg/mL, 4 mL intrathecally as a single dos
16316309|NCT00527332|Drug|Morphine|0.4 mg/mL; 0.5 mL intrathecally as a single dosage
16316310|NCT00527332|Drug|Propofol|2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
16316311|NCT00527332|Drug|Propofol|Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery
16316312|NCT00527332|Drug|Fentanyl|100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.
16316313|NCT00527332|Drug|Rocuronbromid|0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery
16316314|NCT00527332|Drug|Morphine|5 mg is given IV (intravenously) before end of surgery
16316315|NCT00527319|Drug|VT-122 low dose|VT-122 low dose, dose escalated
16316316|NCT00527319|Drug|VT-122 high dose|VT-122 high dose, dose escalated
16316556|NCT00525694|Other|Coke Zero|10 ounces of Coke Zero
16316317|NCT00527306|Dietary Supplement|multivitamin|Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.
16316318|NCT00527293|Procedure|adjuvant therapy|If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
16316319|NCT00527293|Radiation|3-dimensional conformal radiation therapy|3-dimensional conformal radiotherapy twice daily for 5-10 days.
16316320|NCT00527293|Radiation|brachytherapy|Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
16316321|NCT00527280|Procedure|Feasibility ot face transplantation|Feasibility ot face transplantation
16316322|NCT00527267|Drug|Placebo|30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally
16316323|NCT00527267|Drug|AMG 073|30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily
16316324|NCT00527254|Device|Telemedicine system|Possibility of sending the SMBG values of the patients to a web page via phone mobile sms messages. The HCP had a password access to this web page to check the blood glucose values of the patients and if necessary send to them sms messages with recommendations.
16316325|NCT00527241|Behavioral|Raices nuevas|8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.
16316326|NCT00527228|Drug|deflazacort|In the first 12 months, patients will receive no treatment to assess the natural history of the disease. Afterwards, patients will be treated with deflazacort 1mg/kg/day or placebo for the first month on treatment, from the second month on deflazacort or placebo will be administered on an alternate day regimen). Patients will be randomized to six months verum or placebo each, after a 3-months wash-out patients cross over to the alternate treatment for six months. In a 2-years follow-up phase after the double-blind treatment phase, long-term development of the disorder will be documented.
16316327|NCT00527228|Drug|placebo|
16316328|NCT00527215|Drug|darbepoetin alfa|starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL
16316329|NCT00527202|Drug|botulinum toxin A|Botulinum toxin A versus saline in parallel groups
16316330|NCT00527189|Behavioral|Balance Exercises|Home based balance exercises based on Otago Exercise programme
16316331|NCT00527150|Drug|Varenicline Tartrate|Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
16316332|NCT00527150|Drug|Varenicline Tartrate|Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
16316333|NCT00527150|Drug|Varenicline Tartrate|Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
16316334|NCT00527150|Drug|Varenicline Tartrate|The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
16316335|NCT00527150|Drug|Varenicline Tartrate|The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
16316336|NCT00527137|Drug|darbepoetin alfa|Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
16316337|NCT00527137|Drug|rHuEPO|same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
16316338|NCT00527124|Drug|cediranib maleate|Given orally
16316339|NCT00527124|Drug|docetaxel|Given IV
16316340|NCT00527124|Drug|prednisone|Given orally
16316341|NCT00527124|Other|laboratory biomarker analysis|Correlative studies
16316342|NCT00527111|Drug|Cetuximab|
16316343|NCT00527111|Drug|5-fluorouracil|
16316344|NCT00527111|Radiation|Pelvic irradiation|
16316345|NCT00527085|Drug|AMG 073|30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
16316346|NCT00527085|Drug|Placebo|30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
16316347|NCT00527072|Biological|infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
16316348|NCT00527059|Drug|Levosimendan in addition to standard therapy|intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy
16316349|NCT00527059|Drug|spironolactone, beta-blockers,ecc|
16316350|NCT00527046|Drug|CP-424,391|
16316351|NCT00527033|Drug|YM178|Oral
16316352|NCT00527033|Drug|Placebo|Oral
16316353|NCT00527020|Drug|GSK1018921|GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.
16316354|NCT00527020|Drug|Nicotine Lozenges|Nicotine Lozenges will be supplied as 4 milligrams lozenges.
16316355|NCT00527020|Drug|Placebo|Placebo tablets will be given to the subjects.
16316356|NCT00527007|Other|External cooling|External cooling
16316357|NCT00526994|Other|screened|Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
16316358|NCT00526994|Behavioral|universal education|receives referral information
16316359|NCT00526981|Other|Prone position|Prone position during spontaneous breathing.
16316360|NCT00526968|Drug|EVT 101|8 mg capsule, single oral dose
16316361|NCT00526968|Drug|EVT 101|15 mg capsule, single oral dose
16316362|NCT00526968|Drug|placebo|Placebo capsule, single oral dose
16316363|NCT00526942|Behavioral|SAAGE-designed, visual memory-based cognitive training|Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
16316364|NCT00526929|Drug|darbepoetin alfa|10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week
16316365|NCT00526916|Drug|[C-11]PBR28|
16316366|NCT00526903|Behavioral|Elimination Diet|Daily diet change for 8 days.
16316367|NCT00526890|Dietary Supplement|selenomethionine|Oral Twice daily
16316368|NCT00526890|Drug|carboplatin|Weekly IV
16316369|NCT00526890|Drug|paclitaxel|Weekly IV
16316370|NCT00526890|Other|laboratory biomarker analysis|Correlative Study
16316371|NCT00526890|Radiation|radiation therapy|Undergoing radiation Therapy
16316372|NCT00526877|Drug|Risperidone|Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
16316373|NCT00526851|Other|survey administration|Nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).
16316374|NCT00526838|Drug|XL228|1-hour IV infusion
16316375|NCT00526812|Drug|RTA 744|Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.
16316376|NCT00526812|Drug|RTA 744 injection|Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.
16316377|NCT00526799|Drug|Sorafenib|"Phase I: Dose Escalation, Phase II: MTD
~Dose level -1: 200mg po daily Dose level 1: 400mg po daily (MTD) Dose level 2: 400mg po bid"
16316378|NCT00526799|Drug|Topotecan|3.5mg/m2 weekly, 3 weeks on and one week off.
16316379|NCT00526786|Device|CryoSpray Ablation System (510(k) NO: K070893)|no drug interventions specified
16316380|NCT00526773|Other|telephone management plus a motivational intervention|heart failure intervention
16316381|NCT00526773|Other|telephone management with standard patient education|heart failure intervention
16316382|NCT00526760|Drug|Dexmedetomidine|
16316383|NCT00526734|Biological|filgrastim|
16316384|NCT00526734|Biological|pegfilgrastim|
16316385|NCT00526734|Drug|melphalan|
16316386|NCT00526734|Procedure|autologous hematopoietic stem cell transplantation|
16316387|NCT00526695|Drug|Sevoflurane (Preconditioning)|Inhalation of sub-anesthetic doses of sevoflurane
16316388|NCT00526682|Dietary Supplement|Irvingia/cissus combo|
16316389|NCT00526669|Drug|Lapatinib and Capecitabine|oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
16316390|NCT00526656|Drug|sunitinib malate|50mg PO daily 4 weeks on -2 weeks off
16316391|NCT00526643|Drug|gemcitabine|1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles
16316392|NCT00526643|Drug|cisplatin|cisplatin 60 mg/m2 on day 1 for 4 cycles
16316393|NCT00526630|Drug|Methylphenidate (MPD)|Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day.
16316394|NCT00526630|Drug|Placebo|Participants will be given placebo instead of active MPD.
16316395|NCT00526617|Drug|ABT-888|Oral capsules
16316396|NCT00526617|Drug|Temozolomide|Oral capsules
16316397|NCT00526604|Behavioral|work related rehabilitation|"The workplace intervention includes two steps:
~Evaluations of the work site: The occupational ergonomists task is to identify conditions at the work site, as for instance ergonomic, work demand and relations to the employer and colleagues.
~Therapeutic Return to work: The occupational ergonomists will organize contacts and meetings between the employer and the patients and make a schedule for return to work. The therapeutic return-to-work-process will take place at the work place, with progressively more days at work and progressively increasing tasks."
16316398|NCT00526591|Drug|Everolimus|Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week
16316399|NCT00526591|Procedure|conventional surgery|Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
16316400|NCT00526578|Behavioral|Questionnaire|Questionnaire taking about 30-40 minutes to complete.
16316401|NCT00526565|Behavioral|Tapas Acupressure Technique|Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. The TAT pose involves lightly touching the tips of the left thumb and 4th finger to the area 1/8 inch above the inner corner of each eye and the 3rd finger to the point midway between the eyes, about ½ inch above eyebrow level. The right hand is on the back of the head, with the palm cradling the occiput and the thumb just above the hairline. Once in this position, the process is to 1) focus attention on the identified problem or behavior to be changed (e.g., over-eating); 2) focus on a positive thought related to the problem; 3) focus on the thought of healing or clearing the origins of the problem; and 4) focus on an awareness of healing or clearing any storage of the problem, at a cellular, mental, emotional, or energetic level.
16316402|NCT00526565|Behavioral|Social support|The LIFE SS maintenance intervention will consist of a series of professionally facilitated social support groups where the session content is directed by the participants. The contact hours for SS will match those of the TAT intervention. The initial SS group session will orient participants to the basics of weight maintenance, and subsequent sessions will provide opportunities for participants to share experiences and ask questions. Participants may choose to use behavioral tools as desired. In addition to the basic materials about weight loss maintenance used in both maintenance interventions, will we use the materials already used in the weight loss program for the SS group as needed. We will measure adherence by taking attendance at the SS group sessions.
16316403|NCT00526539|Other|Total hip replacement, Spectron and Taperloc|
16316404|NCT00526513|Drug|Insulin Glulisine|subcutaneous injection of insulin glulisine at meal, 1 to 3 injections a day based on the condition of the patient in addition to a basal SC insulin injection at bedtime
16316405|NCT00526500|Behavioral|Tilt Table With Integrated Stepping System|Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.
16316406|NCT00526487|Device|Zenith® Dissection Endovascular System|The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
16316407|NCT00526487|Device|Endovascular Repair|Endovascular Repair
16316408|NCT00526474|Drug|Vorapaxar|2.5-mg tablet daily for at least 1 year
16316409|NCT00526474|Drug|Placebo|matching tablet daily for at least 1 year
16316410|NCT00526461|Drug|HPPH|IV
16316411|NCT00526448|Drug|ribavirin|2000 mg/day
16316412|NCT00526448|Drug|ribavirin|1000-1200 mg/day
16316413|NCT00526448|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 180 mcg/week
16316414|NCT00526448|Drug|epoetin beta|epoetin beta 450 UI/week
16316415|NCT00526435|Behavioral|Walk with Ease - Group|Participate in 6-week, 1 hour per week group assisted classes (with instructor).
16316416|NCT00526435|Behavioral|Walk with Ease - Self|SUbject will receive the WWE workbook and follow it without group/instructor assistance.
16316417|NCT00526422|Procedure|Dental Preventive|
16316418|NCT00526409|Drug|Prednisolone|Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days
16316419|NCT00526409|Drug|Daunorubicin|Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1
16316420|NCT00526409|Drug|Vincristine|Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22
16316421|NCT00526409|Drug|L-Asparaginase|Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22
16316422|NCT00526409|Drug|Cyclophosphamide|Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15
16316423|NCT00526409|Drug|Methotrexate|Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)
16316424|NCT00526409|Drug|Cytosine Arabinoside|Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44
16316425|NCT00526396|Drug|cisplatin|80 mg/m2 on day 1 for 6 cycles
16316426|NCT00526396|Drug|etoposide|100 mg/m2 on days 1,2,3 for 6 cycles
16316427|NCT00526396|Drug|cisplatin|cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
16316428|NCT00526396|Drug|etoposide|etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
16316429|NCT00526383|Drug|Tricyclic antidepressants|antidepressant version medical dispositive
16316430|NCT00526357|Drug|omega-3 fatty acid|Pharmaceutical grade fish oil administered daily in the form of 10 capsules (5 capsules b.i.d.) each containing 400mg of eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA) which will equate to a daily dose of 4000 mg of EPA and 2000 mg or DHA. The matched placebo containing a 50/50 mix of soybean and corn oil will be supplied by the same manufacturer (Ocean Nutrition, Canada)
16316431|NCT00526331|Device|Vigileo Monitor|Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.
16316432|NCT00526331|Device|FloTrac Sensor|Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.
16316433|NCT00526318|Biological|filgrastim|
16316434|NCT00526318|Drug|carboplatin|
16316435|NCT00526318|Drug|cisplatin|
16316436|NCT00526318|Drug|cyclophosphamide|
16316437|NCT00526318|Drug|dacarbazine|
16316438|NCT00526318|Drug|doxorubicin hydrochloride|
16316439|NCT00526318|Drug|etoposide phosphate|
16316440|NCT00526318|Drug|ifosfamide|
16316441|NCT00526318|Drug|isotretinoin|
16316442|NCT00526318|Drug|melphalan|
16316443|NCT00526318|Drug|topotecan hydrochloride|
16316444|NCT00526318|Drug|vincristine sulfate|
16316445|NCT00526318|Drug|vindesine|
16316446|NCT00526318|Procedure|autologous hematopoietic stem cell transplantation|
16316447|NCT00526318|Radiation|iobenguane I 131|
16316448|NCT00526318|Radiation|radiation therapy|
16316449|NCT00526305|Drug|Vincristine|1,5 mg/m2 i.v., days 1 and 8
16316450|NCT00526305|Drug|Daunorubicin|60 mg/m2, i.v., days 1 and 8
16316451|NCT00526305|Drug|Prednisone|60 mg/m2 day, i.v. or oral, days 1 to 14
16316452|NCT00526305|Drug|L-Asparaginase|10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
16316453|NCT00526305|Drug|Mitoxantrone|12 mg/m2 i.v days 15, 16 and 17
16316454|NCT00526305|Drug|Cytosine Arabinoside|1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
16316455|NCT00526305|Drug|Hydrocortisone|10 mg ,15 mg or 20 mg depending of age
16316456|NCT00526305|Drug|Mercaptopurine|50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
16316457|NCT00526305|Drug|Cyclophosphamide|600 mg/m2 day, i.v., days 1 to 15 in consolidation
16316458|NCT00526305|Drug|Dexamethasone|10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
16316459|NCT00526292|Biological|natural killer cell therapy|The patient must be admitted by Day -8 to the Bone Marrow Transplant Service. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor and will be monitored for hematopoietic recovery.
16316460|NCT00526292|Drug|cyclophosphamide|Day -6 cyclophosphamide 60mg/kg infused over 1 hour (dose adjusted for body weight) for 2 days
16316461|NCT00526292|Drug|fludarabine|Day -5 fludarabine 25mg/m2 CIV for 5 days
16316462|NCT00526266|Behavioral|Emotional Freedom Techniques (EFT)|A half hour treatment with EFT following a standardized protocol. Both Range of Motion (ROM) physical issues are treated with EFT, as well as any possible emotional issues underlying limited ROM.
16316463|NCT00526266|Behavioral|Diaphragmatic Breathing (DB)|"Diaphragmatic Breathing (DB) instead of EFT tapping, but with all the Setup Statements and components of the Experimental Group, with the exception of tapping. DB is substituted for tapping."
16316464|NCT00526253|Biological|MyoCell|Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.
16316465|NCT00526253|Biological|MyoCell|Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.
16316466|NCT00526253|Procedure|Hypothermosol|After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.
16316467|NCT00526227|Device|Secura ICD|Secura Implantable Cardioverter Defibrillator (ICD) will be implanted
16316468|NCT00526214|Drug|celecoxib medication|In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
16316469|NCT00526201|Behavioral|12-weeks EnhanceFitness|EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.
16316470|NCT00526201|Behavioral|Control|Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).
16316471|NCT00526188|Drug|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
16316472|NCT00526175|Drug|Prednisone|60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
16316473|NCT00526175|Drug|Vincristine|1,5 mg/m2 i.v., days 8, 15, 22 and 28
16316474|NCT00526175|Drug|Daunorubicin|30 mg/m2, i.v., days 8 and 15
16316475|NCT00526175|Drug|L-Asparaginase|10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
16316476|NCT00526175|Drug|Cyclophosphamide|1000 mg/m2, i.v., day 22.
16316477|NCT00526175|Drug|Methotrexate|Age <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg
16316478|NCT00526175|Drug|Cytosine Arabinoside|Edad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
16316479|NCT00526175|Drug|Mercaptopurine|50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
16316480|NCT00526175|Drug|VP-16|150 mg/m2 i.v., days 14-15 and 42-43
16316481|NCT00526162|Device|Bi-ventricular Implantable Cardioverter Defibrillator|Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
16316482|NCT00526149|Drug|BI 2536|
16316483|NCT00526149|Other|high performance liquid chromatography|
16316484|NCT00526149|Other|mass spectrometry|
16316485|NCT00526149|Other|pharmacological study|
16316486|NCT00526136|Drug|Placebo|
16316487|NCT00526136|Drug|Vernakalant (oral)|Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
16316488|NCT00526123|Device|Symmetric Tip Catheter|Dialysis catheter
16316489|NCT00526123|Device|Conventional Split-tip Catheter|Dialysis Catheter
16316490|NCT00526110|Drug|5-Fluorouracil|2.2 Gm/m^2 IV over 48 hours on Day 1.
16316491|NCT00526110|Drug|Docetaxel|20 mg/m^2 IV over 60 minutes
16316492|NCT00526110|Drug|Oxaliplatin|85 mg/m^2 IV over 120 minutes on Day 1.
16316493|NCT00526097|Drug|Bisacodyl 10 mg|2 x 5 mg bisacodyl once daily
16316494|NCT00526097|Drug|Placebo|Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily
16316495|NCT00526071|Drug|migalastat HCl|
16316496|NCT00526058|Device|Secura then Futura|Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.
16316497|NCT00526058|Device|Futura then Secura|Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.
16316498|NCT00526045|Drug|AUY922 2 mg/m2|
16316499|NCT00526032|Procedure|OIR Imaging|Images from 4 different positions will be taken per lesion. The entire imaging procedure will take about 5 minutes per lesion.
16316500|NCT00526006|Drug|esomeprazole|40 mg od for 8 wks
16316501|NCT00525993|Drug|etoricoxib 90mg 14 days|each patient in this group will receive 90mg once daily, for the 14 days treatment.
16316502|NCT00525993|Drug|etoricoxib 60mg daily for 14 days|Patients in this group will receive 60mg of the drug, daily
16316503|NCT00525980|Behavioral|Computer Program|"Participants will be given a program to learn about breast cancer risk and genetic testing.
~Arm 3 Only = Participants will use the program with the assistance of a promotora (female promoter, community health worker, sometimes known as a lay health advisor)."
16316504|NCT00525980|Behavioral|Focus Group|Focus group discussion lasting about 60 to 90 minutes.
16316505|NCT00525980|Other|Written Materials|Printed materials will be given. The CD-ROM will be offered at the end of the study.
16316506|NCT00525980|Behavioral|Questionnaires|Occasional questionnaire, written or verbal phone survey, about knowledge and attitudes toward cancer and genetic testing.
16316507|NCT00525967|Drug|Methadone plus Acetaminophen or Placebo|Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid
16316508|NCT00525954|Drug|A-002|
16316509|NCT00525941|Drug|NBI-34060|10 mg capsules; dosed as needed for falling back asleep after a bothersome awakening provided there are at least 4 hours remaining in bed; no more than one dose per night.
16316510|NCT00525928|Drug|varenicline|varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization
16316511|NCT00525915|Drug|5-Fluorouracil|"Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks.
~Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15."
16316512|NCT00525915|Drug|Oxaliplatin|"Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks
~Arm B: 100 mg/m^2 IV on Day 1 and 15"
16316513|NCT00525915|Radiation|Radiation Therapy|Radiation treatment every weekday for 5 weeks.
16316514|NCT00525915|Procedure|Surgery|Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
16316515|NCT00525902|Drug|Adalimumab|40 mg delivered every 2 weeks by subcutaneous injection
16316516|NCT00525889|Drug|IL-2|Administered by subcutaneous injection at a dose of 4.5x10^6 IU/day, three times weekly for 28 days starting on day 0.
16316517|NCT00525889|Drug|Rapamycin|Administered orally, initial daily dose of 2mg. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml.
16316518|NCT00525876|Drug|Cyclophosphamide|"Matched Donors:
~750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
~Unrelated or Mismatched Donors:
~1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
16316519|NCT00525876|Drug|Fludarabine|"30 mg/m^2 given intravenously on Days -5 and -3 before transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
16316520|NCT00525876|Drug|Rituximab|"Matched Donors:
~375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
~Unrelated/Mismatched Donors:
~375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)
~For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m^2 given intravenously, then 1000 mg/m^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks.
~DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies:
~375 mg/m^2 then 1000 mg/m^2 weekly x 3 if immunomanipulation is undertaken for persistent disease."
16316521|NCT00525876|Drug|Alemtuzumab|"Unrelated/Mismatched Donors:
~15 mg per day given intravenously days 1 through 3 after transplantation.
~(Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)"
16316522|NCT00525876|Procedure|Allogeneic Stem Cell Infusion|Infusion of stem cells.
16316523|NCT00525863|Drug|oxygen|Patients will be treated with oxygen for 1 month and then for 1 month with regular air with the same flow rate and procedure or randomly in the opposite order. We propose to enrich the inspired oxygen partial pressure from 21 kPA to ~40 kPa in a double blind cross-over design. Ninety percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours/day, throughout the night.
16316524|NCT00525850|Other|high fat diet|high saturated fat no starch diet
16316525|NCT00525850|Other|low saturated fat diet|low calorie low saturated fat low trans fat high fiber diet
16316526|NCT00525837|Drug|fixed dose varenicline|varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.
16316527|NCT00525837|Drug|varenicline|up to 1 mg twice daily
16316528|NCT00525824|Drug|Rosuvastatin (Crestor)|10mg and 20 mg
16316529|NCT00525824|Drug|Ezetimibe|10 mg
16316530|NCT00525824|Drug|Simvastatin|40mg and 80 mg
16316531|NCT00525811|Other|patient dialogue|Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
16316532|NCT00525811|Other|patient information|Information on acute low back pain, information on depression
16316533|NCT00525798|Drug|SMC021 Oral calcitonin|0.8mg SMC021 - oral calcitonin, once daily
16316534|NCT00525798|Drug|SMC021 Placebo|SMC021 - Placebo, once daily
16316535|NCT00525785|Drug|5-Fluorouracil|"2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.
~Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump."
16316536|NCT00525785|Drug|Folinic Acid|200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.
16316537|NCT00525785|Drug|Oxaliplatin|"100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.
~Chemoradiotherapy: 45 mg/m^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week)."
16316538|NCT00525785|Radiation|Radiotherapy|45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.
16316539|NCT00525785|Procedure|Surgery|4-6 weeks after completion of chemoradiotherapy, restaged & surgical resection of the primary tumor and lymph nodes attempted.
16316540|NCT00525772|Drug|ciclesonide|low dose- 50ug and 200ug
16316541|NCT00525772|Drug|ciclesonide|high dose- 100ug and 400ug
16316542|NCT00525759|Drug|5-FU, Epirubicin, Cyclophosphamide, Docetaxel|3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days
16316543|NCT00525759|Drug|5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid|3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days Zoledronic acid: 4mg intravenous infusion Day 2, AFTER FIRST CYCLE CHEMOTHERAPY ONLY
16316544|NCT00525746|Behavioral|Interview|Interview lasting about 50 minutes.
16316545|NCT00525733|Drug|darunavir 800 mg|darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
16316546|NCT00525733|Drug|FTC 200 mg/TDF 300mg|Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
16316547|NCT00525733|Drug|Maraviroc|Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
16316548|NCT00525733|Drug|Raltegravir|Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)
16316549|NCT00525733|Drug|Ritonavir 100 mg|one tablet of ritonavir is taken with darunavir daily
16316550|NCT00525720|Drug|Brachytherapy|Brachytherapy implant procedure lasting 1-2 hours.
16316551|NCT00525720|Behavioral|Questionnaire|Questionnaires taking 30 total minutes.
16316552|NCT00525707|Drug|tezosentan|tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
16316553|NCT00525694|Other|Glucose tolerance test|10 ounces glucose tolerance test solution
16316554|NCT00525694|Other|glucose tolerance test solution|75 grams glucose load
16316557|NCT00525681|Drug|cyclosporine A|Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study.
16316558|NCT00525681|Drug|tacrolimus|Dosing of tacrolimus is given twice daily and individualized as per center practice.
16316559|NCT00525668|Drug|epigallocatechin-gallate (Sunphenon)|200 mg twice daily, after 3 months 400 mg twice daily
16316560|NCT00525668|Drug|placebo|2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
16316561|NCT00525655|Behavioral|Web-Based Multimedia Intervention|Website designed to offer information and support for adolescents and young adults with FAP, viewed for 30-60 minutes.
16316562|NCT00525655|Behavioral|Questionnaire|Questionnaires taking 10-15 minutes to complete.
16316563|NCT00525642|Drug|Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide|Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
16316564|NCT00525642|Drug|Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide|Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
16316565|NCT00525629|Dietary Supplement|Walnuts|48 Grams of Walnuts Daily
16316566|NCT00525629|Dietary Supplement|Control|Control Diet with No Walnuts
16316567|NCT00525616|Drug|Mabthera|Two IV perfusions of 1000mg at 15 days intervals
16316568|NCT00525603|Drug|Cyclophosphamide|200 mg/m^2/day 3-5 IV 5-30 minutes
16316569|NCT00525603|Drug|Fludarabine|20 mg/m^2/day 3-5 IV 5-30 minutes
16316570|NCT00525603|Drug|Alemtuzumab|30 mg Days 1, 3, 5 IV 2-4 hours
16316571|NCT00525603|Drug|Rituximab|375 mg/m^2/day 2 IV 4-6 hours
16316572|NCT00525590|Drug|GLIADEL|Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.
16316573|NCT00525577|Drug|Placebo|Placebo tablet, once daily
16316574|NCT00525577|Drug|AGI-1067|75 mg AGI-1067 tablet, once daily
16316575|NCT00525577|Drug|AGI-1067|150 mg AGI-1067 Tablet, once daily
16316576|NCT00525564|Drug|Placebo|Placebo diskus inhalation powder
16316577|NCT00525564|Drug|Salmeterol diskus inhalation powder|50 micrograms twice a day
16316578|NCT00525551|Drug|Acetylcysteine|150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.
16316579|NCT00525551|Drug|Placebo (NaCl)|300 mL 0.9% NaCl
16316580|NCT00525538|Radiation|conformal radiotherapy|
16316581|NCT00525525|Drug|Bevacizumab|Patients are given 10 mg/kg IV Q2 weeks.
16316582|NCT00525525|Drug|Tarceva|Patients receive 150 mg PO daily. If patients are not experiencing intolerable toxicity, they may escalate their dose to 200 mg PO daily. If patients are experiencing intolerable toxicity, their dose will be held until the toxicity improves or resolves, then re-treated at a lower dose level, i.e. 100 mg PO daily.
16316583|NCT00525525|Drug|Temozolomide|Patients receive 200 mg/m2 for Days 1-5 of every 28 day cycle. Although the calendar days may be slightly altered, the patient should always receive this dose for 5 days within a treatment cycle. If the patient experiences certain toxicities specified in the protocol, Temodar will be held then given at a reduced dose, i.e. 150 mg/m2 Days 1-5.
16316584|NCT00525512|Drug|tiotropium 18 mcg|Oral inhalation once daily of 18mcg tiotropium via handihaler
16316585|NCT00525512|Drug|Placebo|Oral inhalation of once-daily placebo matching tiotropium via handihaler
16316586|NCT00525499|Drug|ASC-J9 cream|Topical application to the face twice daily for 12 weeks.
16316587|NCT00525499|Drug|placebo|vehicle control applied topically twice daily for 12 weeks
16316588|NCT00525486|Drug|Nifedipine extended release|Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
16316589|NCT00525473|Drug|Azathioprine|azathioprine usual dosage 100mg per day
16316590|NCT00525460|Behavioral|Fertility-Sparing Survey|A questionnaire completed either in the clinic or at home
16316591|NCT00525447|Drug|SGN-40|2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
16316592|NCT00525447|Drug|lenalidomide|Up to 25 mg daily of a 21-day cycle.
16316593|NCT00525447|Drug|dexamethasone|40 mg administered weekly.
16316594|NCT00525434|Device|Seraffix LTB|wounds closure by using laser and albumin
16316595|NCT00525421|Drug|Curcuminoids|Curcuminoids tablets 2000mg three times per day for 12 days
16316596|NCT00525421|Drug|Placebo|
16316597|NCT00525408|Biological|Mycobacterium w.|Immunomodulator
16316598|NCT00525408|Drug|Docetaxel|Chemotherapeutic agent
16316599|NCT00525395|Genetic|Sequential phototherapy|Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
16316600|NCT00525395|Procedure|Continuous phototherapy|Group B: 6 months non-stop treatment.
16316601|NCT00525382|Drug|levocetirizine dihydrochloride|
16316602|NCT00525356|Device|Medtronic Talent Stent-Graft-System|
16316603|NCT00525330|Drug|KRP-104 QD Drug: Placebo Drug: Metformin|KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal
16316604|NCT00525330|Drug|Placebo Drug: Metformin|Two tablets 15 to 30 minutes before each meal, morning and evening.
16316605|NCT00525330|Drug|KRP-104 BID Drug: Placebo Drug: Metformin|KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
16316606|NCT00525317|Drug|"Nycoplus Magnesium (120 mg x 3 daily for 2 weeks)"|120 mg x 3 or placebo
16316607|NCT00525304|Behavioral|Self-management program for chronic illness|Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
16316656|NCT00524797|Dietary Supplement|Profonycia|
16316712|NCT00524303|Drug|FEC75|5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles
16318932|NCT00507520|Procedure|Half dose almonds+half dose muffin|
16316608|NCT00525291|Device|Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation|In the 3T arm, patients were stimulated with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 Hz. Anxious patients trained at first only in the biofeedback mode. The stimulation was introduced after four weeks for these patients. Patients were instructed to carry out the training at home, with an alternating combination in the morning and with EMG-triggered stimulation in the evening, each for 20-minute periods. Apart from this, the protocol of the active treatment group was identical to that of the control group.
16316609|NCT00525291|Device|EMG-biofeedback alone|In the biofeedback arm, patients were instructed to carry out EMG-biofeedback training at home, standing, mornings and evenings, for 20-minute periods. The core of the task was to pull the plug-electrode upward inside the anal channel, like a lift, and to hold it there during varying periods of tension. This can only be done successfully if the perineum rises and at the same time the puborectal muscle is activated. Just squeezing the sphincter muscles does not produce this lifting effect.
16316610|NCT00525278|Drug|Levocetirizine dihydrochloride|
16316611|NCT00525265|Drug|OPC-41061(Tolvaptan)|Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
16316612|NCT00525265|Drug|Placebo|Subjects will be orally administered placebo once daily after breakfast for seven days.
16316613|NCT00525252|Drug|Baclofen|Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.
16316614|NCT00525252|Drug|placebo|Placebo will be orally administered for 12 consecutive weeks
16316615|NCT00525239|Drug|ritonavir, lopinavir/ritonavir, atazanavir/ritonavir, efavirenz|100 mg, twice daily, for four weeks
16316616|NCT00525213|Drug|Rob 803|two capsules per day during 12 weeks
16316617|NCT00525213|Drug|Placebo|two capsules per day during 12 weeks
16316618|NCT00525200|Drug|5-Fluoruracil, Cisplatinum|"5 FU 1000mg/m2; days 1-5; 3 cycles: q21
~Cisplatin 80mg/m2; day 1; 3 cycles: q21"
16316619|NCT00525200|Drug|Docetaxel|Docetaxel 75mg/m2, day 1; 3 cycles; q21
16316620|NCT00525174|Device|Bangerter filters|Bangerter filter worn on sound eye spectacle lens full time
16316621|NCT00525174|Device|Patching|2 hours daily patching of the sound eye
16316622|NCT00525174|Procedure|Near activities|one hour near visual activities
16316623|NCT00525161|Drug|sorafenib|400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
16316624|NCT00525148|Drug|BIBW 2992|This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs
16316625|NCT00525135|Drug|Valproic Acid|"OUTLINE: This is a pilot study.
~Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.
~Quality of life is assessed at the end of every week through a study diary.
~Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months."
16316626|NCT00525109|Other|No Intervention|No intervention
16316627|NCT00525096|Drug|placebo|2 tablets twice a day per os
16316628|NCT00525096|Drug|Celecoxib|2*200 mg tablets twice a day per os
16316629|NCT00525096|Drug|Exemestane|Exemestane 25 mg per day per os
16316630|NCT00525057|Drug|Dalteparin|Given SC
16316631|NCT00525044|Drug|Ambroxol|
16316632|NCT00525044|Drug|Placebo|
16316633|NCT00525031|Drug|Temozolomide (TMZ)|150 mg/m^2 by mouth once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
16316634|NCT00525031|Drug|Pegylated Interferon Alpha-2b (PGI)|0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
16316635|NCT00525018|Device|contact heat evoked potential stimulator|
16316636|NCT00525005|Drug|DOS (Docetaxel, Oxaliplatin and S-1)|Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)
16316637|NCT00524966|Procedure|Bipolar Versus Ultrasonic Hemostasis Techniques|OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.
16316638|NCT00524953|Device|EUMATRON - EN 600 NT|frequency - once a week, starting 4 days after transplantation for four weeks (total of 4 treatments) each treatment will last ~20 minutes. In addition - standard GVHD preventive protocol will be given to patients (including cyclosporine and steroids - if necessary)
16316639|NCT00524940|Biological|Inactivated, Split-Virion Influenza Virus|0.5 mL, Intramuscular
16316640|NCT00524927|Drug|Methoxyflurane|
16316641|NCT00524927|Drug|Normal Saline|
16316642|NCT00524914|Drug|apomorphine|Acute apomorphine subcutaneous 3 mg
16316643|NCT00524914|Drug|placebo|placebo subcutaneous
16316644|NCT00524901|Drug|Epoetin alpha|A single dose of epoetin alpha during CABG for three vessel disease, 60.000 IU intravenously.
16316645|NCT00524901|Drug|NaCl 0.9%|A single dose of NaCl 0.9% during CABG for three vessel disease, 1 ml intravenously.
16316646|NCT00524888|Procedure|suturing laceration|suturing simple lacerations of the hand
16316647|NCT00524888|Procedure|bioadhesive|using bioadhesive on simple lacerations of the hand
16316648|NCT00524875|Drug|Bevacizumab|One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy
16316649|NCT00524862|Drug|Optimized medical therapy|Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
16316650|NCT00524862|Device|Implantable Cardioverter Defibrillator|an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly
16316651|NCT00524849|Biological|Zoledronic acid|Zometa 1 mg weekly (intravenous)
16316652|NCT00524849|Drug|Zoledronic acid|Zometa 4 mg every four weeks (intravenous)
16316653|NCT00524836|Drug|levocetirizine dihydrochloride|
16316654|NCT00524810|Drug|Pegylated liposomal doxorubicin|Caelyx 30 mg/m² day 1 every 3 weeks
16316655|NCT00524810|Drug|Docetaxel|Taxotere 75 mg/m² day 2 every 3 weeks
16316657|NCT00524784|Biological|ApoCell|Three subjects per cohort will be treated with ApoCell according to an escalating schedule of doses starting at a single dose of 35 million apoptotic cells/kg in the first cohort of three subjects. Unless a DLT is experienced by subjects in a given cohort, the dose in the subsequent cohort will be increased by two-fold. The second cohort will receive 70 millions cells/kg, and the third cohort 140 millions cells/kg. The final fourth cohort will receive 210 millions cells/kg.
16316658|NCT00524758|Device|ologen (oculusgen) collagen matrix|Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
16316659|NCT00524758|Drug|MMC in Trabeculectomy|MMC in Trabeculectomy
16316660|NCT00524745|Biological|Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.
16316661|NCT00524732|Biological|Tetanus and diphtheria toxoids and acellular pertussis|0.5 mL, Intramuscular
16316662|NCT00524719|Procedure|Open Reduction and Internal Fixation|Fixation with volar locked plate
16316663|NCT00524719|Procedure|Non-Spanning External Fixation|Radio-radial external fixation
16316664|NCT00524719|Procedure|Closed Reduction with Percutaneous Fixation|Percutaneous intrafocal pinning (Kapandji technique)
16316665|NCT00524706|Drug|S-1, oral Leucovorin, Oxaliplatin|
16316666|NCT00524693|Drug|Montelukast|4mg sachets
16316667|NCT00524693|Drug|Placebo granules|
16316668|NCT00524680|Dietary Supplement|cholecalciferol|Given orally
16316669|NCT00524667|Drug|Valproic acid & fludarabine|valproic acid (VPA) starting dose of 15 mg/day p.o. in divided doses, increased weekly by 5 mg/kg/day until >1mM Fludarabine 40 mg/m2/day orally will be added after completing 28 days of VPA if participant has been identified as having stable or progressive disease.
16316670|NCT00524654|Procedure|HVLA chiropractic manipulation|
16316671|NCT00524615|Drug|spironolactone|25 mg of spironolactone once daily or placebo for 2 months
16316672|NCT00524602|Procedure|Catheter ablation using the Stereotaxis equipment|Energy delivery through ablation catheter during an interventional catheterisation of the heart.
16316673|NCT00524589|Dietary Supplement|calcitriol|IV
16316674|NCT00524589|Drug|dexamethasone|Oral
16316675|NCT00524589|Genetic|protein expression analysis|Correlative Study
16316676|NCT00524589|Other|laboratory biomarker analysis|Correlative Study
16316677|NCT00524576|Biological|Engerix™-B|One dose (10µg Hepatitis B surface antigen (HBsAg))
16316678|NCT00524550|Dietary Supplement|moderate alcohol consumption|drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks
16316679|NCT00524524|Drug|ARQ 501|Weekly IV Infusion; 450 mg/m2
16316680|NCT00524511|Device|Surgical skin staples|Standard method to close abdominal surgical wounds
16316681|NCT00524511|Device|Dermabond|Alternative method (superglue) to close abdominal surgical wounds
16316682|NCT00524498|Drug|OPC-18|OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
16316683|NCT00524498|Drug|cisplatin|infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
16316684|NCT00524485|Drug|aminolevulinic acid|
16316685|NCT00524485|Procedure|laser therapy|
16316686|NCT00524472|Other|Hyperinsulinemic-normoglycemic clamp|Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
16316687|NCT00524472|Other|insulin at the standard of care levels|Subjects will be administered insulin at the standard of care levels established by the participating institution.
16316688|NCT00524459|Drug|docetaxel|
16316689|NCT00524459|Drug|pegylated liposomal doxorubicin hydrochloride|
16316690|NCT00524459|Procedure|conventional surgery|
16316691|NCT00524459|Procedure|neoadjuvant therapy|
16316692|NCT00524446|Dietary Supplement|Milk-containing fortified spread|Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.
16316693|NCT00524446|Dietary Supplement|Soy-containing fortified spread|Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.
16316694|NCT00524446|Dietary Supplement|Maize-soy flour|Counseling + Vitamin A as for ST_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.
16316695|NCT00524433|Drug|tezosentan|tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
16316696|NCT00524433|Drug|placebo|
16316697|NCT00524420|Device|rTMS|10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
16316698|NCT00524420|Device|Sham rTMS|10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
16316699|NCT00524407|Drug|Epoetin alfa|
16316700|NCT00524381|Drug|Etanercept (Enbrel)|TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
16316701|NCT00524381|Drug|Sodium chloride (placebo)|NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.
16316702|NCT00524368|Drug|Darunavir (DRV)|DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.
16316703|NCT00524368|Drug|Ritonavir (rtv)|DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.
16316704|NCT00524342|Drug|Oprelvekin, Interleukin 11, IL-11|25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
16316705|NCT00524316|Drug|doxorubicin hydrochloride|Transarterial chemoembolization
16316706|NCT00524316|Drug|sunitinib malate|Given Orally
16316707|NCT00524316|Other|laboratory biomarker analysis|Correlative Study
16316708|NCT00524316|Procedure|hepatic artery embolization|Surgical procedure
16316709|NCT00524316|Procedure|quality-of-life assessment|Correlative Study
16316710|NCT00524303|Drug|Trastuzumab|4mg/kg IV loading dose followed by 2mg/kg IV weekly
16316711|NCT00524303|Drug|Paclitaxel|80mg/m2 IV weekly for 4 (21 day) cycles
16316713|NCT00524303|Drug|Lapatinib|1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3
16316714|NCT00524277|Biological|GP2 peptide + GM-CSF vaccine|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
16316715|NCT00524277|Biological|GM-CSF (sargramostim)|GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
16316716|NCT00524277|Biological|AE37 + GM-CSF vaccine|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
16316717|NCT00524277|Biological|GM-CSF (sargramostim)|Given intradermally every 3-4 weeks for a total of up to 6 inoculations
16316718|NCT00524264|Drug|ketorolac|"Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.
~Placebo"
16316719|NCT00524251|Drug|esomeprazole|
16316720|NCT00524238|Drug|L-thyroxine|The hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months.
16316721|NCT00524225|Drug|Neumega (Oprelvekin, Interleukin 11, IL-11)|25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
16316722|NCT00524199|Drug|Mesna|12 mg/kg IV infusion over five minutes at the beginning of dialysis thrice weekly.
16316723|NCT00524199|Other|Saline|Saline IV infusion over five minutes at the beginning of dialysis thrice weekly.
16316724|NCT00524186|Drug|fluorouracil|Given IV
16316725|NCT00524186|Drug|irinotecan hydrochloride|Given IV
16316726|NCT00524186|Drug|leucovorin calcium|Given IV
16316727|NCT00524186|Drug|sunitinib malate|Taken Orally
16316728|NCT00524186|Other|flow cytometry|Correlative Study
16316729|NCT00524186|Other|pharmacological study|Correlative Study
16316730|NCT00524173|Drug|Tenofovir & Emtricitabine|
16316731|NCT00524173|Drug|Tenofovir|
16316732|NCT00524160|Drug|Fentanyl transdermal patch|
16316733|NCT00524147|Procedure|Pigtail drainage|
16316734|NCT00524134|Drug|Carvedilol-CR|Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication.
16316735|NCT00524121|Drug|erlotinib hydrochloride|Oral
16316736|NCT00524121|Other|immunohistochemistry staining method|Correlative Study
16316737|NCT00524121|Radiation|radiation therapy|Radiation Treatment
16316738|NCT00524095|Drug|azithromycin and fluticasone|azithromycin 500 mg once a day three times a week for 6 months and then inhaled steroids (fluticasone 500 ug bid) for 6 months
16316739|NCT00524095|Drug|fluticasone and azithromycin|inhaled steroids (fluticasone 500 ug bid) for 6 months and then azithromycin 500 mg once a day three times a week for 6 months
16316740|NCT00524069|Biological|bevacizumab|
16316741|NCT00524069|Drug|capecitabine|
16316742|NCT00524069|Drug|gemcitabine hydrochloride|
16316743|NCT00524069|Other|flow cytometry|
16316744|NCT00524069|Other|laboratory biomarker analysis|
16316745|NCT00524069|Procedure|adjuvant therapy|
16316746|NCT00524069|Procedure|computed tomography|
16316747|NCT00524069|Procedure|neoadjuvant therapy|
16316748|NCT00524056|Drug|Carisbamate|two 100 mg tablets twice per day
16316749|NCT00524056|Drug|Placebo|two placebo tablets twice per day
16316750|NCT00524043|Drug|Paliperidone ER|1.5 mg tablet once daily for 6 weeks
16316751|NCT00524043|Drug|Placebo|Once daily for 6 weeks
16316752|NCT00524043|Drug|Paliperidone ER|6 mg tablet once daily for 6 weeks
16316753|NCT00524030|Drug|pregabalin 600 mg/day|pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
16316754|NCT00524030|Drug|pregabalin 150 mg/day|pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
16316755|NCT00524017|Biological|cetuximab|given IV
16316756|NCT00524004|Biological|Anti-CsbD Bovine IgG|Three times a day for seven days
16316757|NCT00524004|Other|Placebo|Three times a day for seven days
16316758|NCT00524004|Biological|Anti-CS17 Bovin IgG|Three times a day for seven days
16316759|NCT00523991|Drug|tiotropium|Oral inhalation once daily of 18mcg tiotropium via handihaler
16316760|NCT00523991|Drug|Placebo|Oral inhalation once daily of placebo matching tiotropium via handihaler
16316761|NCT00523978|Device|Arctic Front® Cryoablation Catheter|Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.
16316762|NCT00523978|Drug|Flecainide or Sotalol or Propafenone|Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
16316763|NCT00523965|Drug|amphotericin B deoxycholate|Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
16316764|NCT00523965|Drug|Liposomal Amphotericin B with Miltefosine|Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg
16316765|NCT00523965|Drug|Liposomal Amphotericin B and Paromomycin Sulfate|AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11
16316766|NCT00523965|Drug|miltefosine + Paromomycin sulfate|oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days
16316767|NCT00523952|Drug|tacrolimus ointment|tacrolimus, single arm, 0.1 ointment
16316768|NCT00523939|Drug|cytarabine liposome injection|50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
16316769|NCT00523926|Drug|TMC207|
16316770|NCT00523913|Drug|rosiglitazone|
16316771|NCT00523900|Dietary Supplement|Quaker Complete Nutrition Supplements|3-6 250ml cans of Quaker Complete Nutrition Supplements per day
16316772|NCT00523887|Drug|Fentanyl transdermal therapeutic system|
16316773|NCT00523861|Dietary Supplement|Moderate alcohol consumption|
16316774|NCT00523848|Drug|bortezomib|IV
16316775|NCT00523848|Drug|pegylated liposomal doxorubicin hydrochloride|IV
16316776|NCT00523848|Drug|thalidomide|Oral
16316777|NCT00523822|Other|Spinal Manipulative Therapy|
16316778|NCT00523809|Drug|Bevacizumab|10 mg/kg IV Daily Over 30 Minutes for 1 Day
16316779|NCT00523809|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Stem Cell Transplantation on Day 8.
16316780|NCT00523809|Drug|Fludarabine|25 mg/m^2 IV Daily Over 30 Minutes for 5 Days
16316781|NCT00523809|Drug|Melphalan|70 mg/m^2 IV Daily Over 30 Minutes for 2 Days
16316782|NCT00523809|Drug|Thymoglobulin|0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.
16316783|NCT00523770|Procedure|Urine sample collection|Urine samples will be collected and tested for the presence of S. pneumoniae
16316784|NCT00523757|Drug|Spironolactone|
16316785|NCT00523757|Drug|Placebo|
16316786|NCT00523744|Drug|Amlodipine|Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
16316787|NCT00523744|Drug|Olmesartan medoxomil|Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
16316788|NCT00523744|Drug|Amlodipine+valsartan|Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
16316789|NCT00523744|Drug|Hydrochlorothiazide|Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.
16316790|NCT00523731|Procedure|Angiogenic Cell Precursors (ACPs) or Vescell TM|
16316791|NCT00523718|Drug|riluzole|50 mg PO bid, 12 weeks
16316792|NCT00523718|Drug|placebo|placebo, 1 capsule PO bid, 12 weeks
16316793|NCT00523705|Drug|escitalopram|10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
16316794|NCT00523705|Other|placebo|Placebo tablets matched to drug
16316795|NCT00523692|Drug|Etanercept, methotrexate and depomedrone|Etanercept (50mg weekly; subcutaneous) Methotrexate (7.5-25mg weekly; oral) Depomedrone (up to 120mg; intraarticular / intramuscular)
16316796|NCT00523692|Drug|depemedrone|depomedrone (up to 120mg im/ia) methotrexate (added after symptoms have been present for 12 weeks)
16316797|NCT00523666|Drug|Galantamine (Reminyl®)|8mg - 24mg
16316798|NCT00523666|Drug|Placebo/Galantamine (Reminyl®)|"Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months.
~Dose scheme: 8mg-24mg"
16316799|NCT00523653|Other|blood test|looking at DNA
16316800|NCT00523640|Drug|combination of gemcitabine, capecitabine, and bevacizumab|gemcitabine 1000 mg/m^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
16316801|NCT00523588|Procedure|laser treatment (Candela Vbeam Perfecta™)|This laser has an adjustable pulse duration (0.45-40 ms), fixed wavelength 595 nm, spot size (3 mm, 5 mm, 7 mm, and 10 mm), and incident fluence range of 10-40 J/cm2. The laser is also equipped with a dynamic cooling device (DCD) (FDA cleared under K001589) that delivers cryogen (R-134a) from a small nozzle positioned 4 cm above the skin at an angle of approximately 70 degrees with respect to the skin surface. All patients will be treated with the laser device on which the varying cooling device parameters will be selected based on the clinical judgment of the treating physician. Factors used in this decision include patient age, skin type and epidermal pigmentation, size and depth of vessels, color of lesions, anatomic location, etc. In all instances, a test-dose in an inconspicuous location on the skin will be conducted prior to the first treatment.
16316802|NCT00523575|Dietary Supplement|Cubitan|400 ml/d
16316803|NCT00523562|Other|diet intervention|controlled hypercaloric high fructose, high fat, or high fat/high protein diet
16316804|NCT00523549|Drug|valsartan|160 mg or 320 mg tablets once a day
16316805|NCT00523549|Drug|amlodipine|5 mg or 10 mg tablets once a day
16316806|NCT00523536|Behavioral|Patient Navigator - Nurse Team Intervention|The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.
16316807|NCT00523523|Behavioral|Constraint-Induced Movement Therapy + auditory rhythm cues|The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. Participants in the experimental group will perform this practice to the beat of a metronome. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
16316808|NCT00523523|Behavioral|Constraint-Induced Movement Therapy|The intervention is functional task practice with the paretic arm and hand for 4 hours/day for 10 sessions over 2 weeks plus a home program for the intervening weekend. All participants will also wear a mitt on the less affected hand for up to 90% of waking hours.
16316809|NCT00523510|Procedure|Infant feeding counseling that includes Flash-heat|Intensive infant feeding counseling which includes description and demonstration of the WHO recommended option for HIV-infected mothers to pasteurize their breastmilk. Flash-heat pasteurization will be described and demonstrated to interested mothers. More intensive counseling and support will be provided home visits.
16316810|NCT00523497|Device|Non invasive mechanical ventilation|
16316811|NCT00523471|Procedure|Blood test|
16316812|NCT00523458|Drug|efavirenz or nevirapine|"Patients co-infected with HIV and TB will receive either standard doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or high doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin."
16316813|NCT00523445|Drug|Varenicline(Chantix)|The dose of antipsychotic drug will remain fixed throughout the study and the titration of varenicline will be as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice per day for days 4 to 7, then 1 mg twice per day through week 8.
16316814|NCT00523445|Drug|Placebo|The dose of antipsychotic and concomitant medications remained fixed throughout the study and the titration of varenicline was as follows: Placebo will be supplied twice daily through week 8.
16316815|NCT00523432|Drug|Topotecan|Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
16316816|NCT00523432|Drug|CCI-779 (temsirolimus)|Weekly 25mg dose via IV infusion.
16318933|NCT00507520|Procedure|Full dose whole wheat muffin|
16316817|NCT00523419|Drug|Pemetrexed|500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.
16316818|NCT00523406|Procedure|Photodynamic therapy and intravitreal triamcinolone|combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD
16316819|NCT00523393|Drug|Insulin Glargin|Titration of bedtime insulin glargin aiming at normal morning fasting glucose
16316820|NCT00523393|Drug|Human Insulin|Titration of bedtime human insulin aiming at normal morning fasting glucose
16316821|NCT00523380|Drug|recombinant interleukin-21|Administered i.v. in treatment cycles of 28 days.
16316822|NCT00523380|Drug|caelyx (pegylated liposomal doxorubicin)|Administered i.v. in treatment cycles of 28 days.
16316823|NCT00523367|Procedure|24 hour pH testing|24 hour pH testing will be used to screen patients
16316824|NCT00523354|Drug|Infliximab|Induction therapy with 2 infusions, each 5 mg/kg body weight within 2 wks
16316825|NCT00523341|Biological|Denosumab|Administered by subcutaneous injection once every 6 months.
16316826|NCT00523328|Drug|BG9924|dosage administered as per Biogen-idec protocol
16316827|NCT00523302|Device|Active TMS|Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
16316828|NCT00523302|Device|Sham TMS|Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
16316829|NCT00523289|Drug|Bupivacaine|Dosage: 150mg at once for anesthesia induction
16316830|NCT00523289|Drug|Ropivacaine|Single dose of ropivacaine, 150mg
16316831|NCT00523263|Device|heparin-bonded and collagen coated polyster|femoro-popliteal bypass
16316832|NCT00523263|Device|Human umbilical vein femoro-popliteal bypass|
16316833|NCT00523250|Drug|AR-102 0.003% Ophthalmic Solution|
16316834|NCT00523250|Drug|AR-102 0.005% Ophthalmic Solution|
16316835|NCT00523250|Drug|AR-102 0.01% Ophthalmic Solution|
16316836|NCT00523250|Drug|AR-102 0.03% Ophthalmic Solution|
16316837|NCT00523250|Drug|AR-102 Vehicle Ophthalmic Solution|
16316838|NCT00523237|Drug|Raltegravir|400 mg Twice daily for 24 weeks
16316839|NCT00523224|Procedure|Angiogenic Cell Precursors(ACPs) or Vescell TM|at least 1.5 million of ACPs per one time of treatment
16316840|NCT00523224|Biological|Angiogenic Cell Precusors|Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment
16316841|NCT00523211|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily.
16316842|NCT00523211|Drug|Placebo|One tablet of placebo once daily.
16316843|NCT00523185|Drug|Lorazepam|Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
16316844|NCT00523185|Drug|Diazepam|Diazepam 20 mg by mouth every two hours x 3 doses, or for parenteral treatment, diazepam 10 mg intravenously every one hour x 6 doses. Give additional diazepam 10 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
16316845|NCT00523172|Procedure|manual or manipulative therapy|Active comparator will receive 9 treatments of manual or manipulative therapy to the hip (HVLA hip manipulations per protocol 1) with pre-manipulative static and post manipulative active-assisted stretch of hip muscles after each manipulation.
16316846|NCT00523172|Procedure|Manual / Manipulative Therapy|Active comparator will receive 9 treatments of manual or manipulative therapy to the lumbosacral, sacroiliac, hip and knee, ankle and foot joints (HVLA and Grades I-IV mobilization per protocol 2) stretching and exercise.)
16316847|NCT00523172|Procedure|Supportive Care|"Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous trial) throughout the follow up period.
~Enrolled subjects will commonly receive 2 treatments per week (occasionally, less or more than 1 to 2 treatments per week due to (College or University) semester breaks, exams, clinic closures and so forth) until 9 treatments are completed."
16316848|NCT00523159|Drug|Endoxana, IMA901, Leukine|a single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901
16316849|NCT00523159|Drug|IMA901 and Leukine|Intradermal injection of GM-CSF followed by intradermal injection of IMA901
16316850|NCT00523146|Drug|Kanion Capsule|
16316851|NCT00523133|Drug|naltrexone|50 mg naltrexone daily for 3 months
16316852|NCT00523133|Drug|naltrexone|50 mg of naltrexone daily for 6 months
16316853|NCT00523133|Behavioral|Broad Spectrum Treatment|8-14, one hour sessions over 6 months
16316854|NCT00523133|Behavioral|Motivational Enhancement Treatment|4, 20 minute sessions over 3 months
16316855|NCT00523120|Drug|diclofenac sodium|topical solution used in ear 5 drops 8 3/day
16316856|NCT00523120|Drug|dexotc|aural drops
16316857|NCT00523107|Drug|PG2|PG2 500 mg / 500 ml normal saline t.i.w. per week
16316858|NCT00523107|Drug|Placebo|500 ml normal saline t.i.w. per week
16316859|NCT00523081|Behavioral|Cognitive Behavioral Therapy (CBT)|Half the teens in the study will also meet with a research counselor for five to nine individual, weekly sessions that last about 50 minutes each. Whether a teen attends the weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned to these sessions, they will learn ways to deal with stress and feel better. If teens take part in the counseling sessions, the study counselor will also talk to the teen's doctor from time to time to help plan for the best possible care.
16316860|NCT00523081|Behavioral|Active control|Teens in the active control arm will keep seeing their doctor as usual. Teens and a parent are interviewed briefly over the phone to see if they are appropriate for the study. If they qualify for the study, there is an hour-long interview with teen over the telephone and a 30 minute interview with the parent. They will be interviewed six more times in the next two years.
16316861|NCT00523068|Drug|Tolterodine|
16316862|NCT00523068|Procedure|tension free vaginal tape|
16316863|NCT00523055|Drug|Lidocaine|Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline
16316864|NCT00523042|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
16316865|NCT00523042|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16316866|NCT00523029|Behavioral|Chronic Disease Self-Management Program|Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.
16316867|NCT00523016|Procedure|Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)|LCCNPAP: acupuncture needle insertion at acupuncture points on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks.
16316868|NCT00523016|Procedure|Sham acupuncture|Sham acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks. This group will be offered the LCCNPAP treatment at the completion of study participation.
16316869|NCT00523003|Dietary Supplement|high protein|2.2 g protein/kg of LBM per day
16316870|NCT00523003|Dietary Supplement|standard protein|1.1 g protein/kg LBM/day standard protein diet
16316871|NCT00522990|Drug|AT9283|Three weekly intravenous administration of AT9283
16316872|NCT00522964|Behavioral|behavioral intervention|The intervention is based on Social Cognitive Theory and principles of Chinese culture and practices. The intervention program includes a one-hour small-group session for eight weeks for children and two 2-hour small-group sessions for parents.
16316873|NCT00522951|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
16316874|NCT00522951|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
16316875|NCT00522951|Drug|ProHance|ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
16316876|NCT00522938|Drug|CHR-2797 (tosedostat)|Once daily, oral ingestion of CHR-2797 capsules(PhaseI: 120mg, 160mg or 200mg depending on cohort or Phase II: recommended dose) capsules until progressive disease or withdrawal from the study
16316877|NCT00522938|Drug|erlotinib|Once daily, oral ingestion of erlotinib tablets 150mg tablets until progressive disease or withdrawal from the study. Per protocol, the Investigator may reduce the dose of erlotinib or cease treatment with erlotinib(per label) with Sponsor approval.
16316878|NCT00522925|Drug|PS433540|200mg capsule, once daily for 28 days
16316879|NCT00522925|Drug|placebo|placebo capsule, once daily for 28 days
16316880|NCT00522925|Drug|PS433540|500mg capsule, once daily for 28 days
16316881|NCT00522912|Procedure|Trichiasis surgery|Posterior lamella tarsal rotation
16316882|NCT00522912|Procedure|Epilation|Epilation of lashes by another well sighted person using quality epilating forceps
16316883|NCT00522899|Behavioral|Group 1|Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
16316884|NCT00522899|Behavioral|Group 2|Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
16316885|NCT00522899|Behavioral|Group 3|Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
16316886|NCT00522899|Behavioral|Group 4|Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
16316887|NCT00522886|Drug|Cetuximab|"Eligible patients will be given 2 cycles(of 21 days) of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. Patients without progressive disease will be entered in the phase I dose-escalation part of the study. Chest radiation will be given concurrently with cetuximab, cisplatin and vinorelbine, which will be escalated in 3 steps until dose-limiting toxicity occurs.
~14 days after the last gemcitabine (=day 43), radiotherapy is started : First 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose of 19 Gy. Cetuximab: 400 mg/m2 7 days before radiotherapy (= day 36) and during the course of radiotherapy a weekly dose 250 mg/m2. Cetuximab will be delivered at the same days as chemotherapy.
~Cisplatin(all steps): 50 mg/m2 days 43, 50; 40 mg/m2 day 64.
~Vinorelbine:
~Step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73."
16316888|NCT00522873|Drug|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
16316889|NCT00522873|Drug|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
16316890|NCT00522860|Procedure|Trichiasis surgery with absorbable sutures|Posterior lamellar tarsal rotation. Vicryl sutures, 5/0, 3/8 curved needle, cutting. Three everting sutures.
16316891|NCT00522860|Procedure|Trichiasis surgery with non-absorbable sutures|Posterior lamellar tarsal rotation. Silk sutures. 4/0. 3/8 curved cutting needle. Three sets of everting sutures.
16316892|NCT00522834|Drug|Elesclomol (STA-4783)|213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
16316893|NCT00522834|Drug|Paclitaxel|80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops
16316894|NCT00522821|Drug|intravenous immunoglobulins|"Adults: 600 mg/kg bodyweight every 3 weeks
~Children: 800 mg/kg bodyweight every 3 week"
16316895|NCT00522821|Drug|antibiotics|"Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid.
~Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid."
16316896|NCT00522808|Drug|A-831|
16316897|NCT00522795|Drug|PPX with cisplatin and radiation|weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
16316898|NCT00522782|Drug|Nebulized Budesonide|Pulmicort Respules 0.5mg/2cc
16316899|NCT00522782|Device|Nitric Oxide Analyzer|Niox NO analyzer
16316900|NCT00522769|Behavioral|Cognitive Behavioral Therapy|Girls enrolled in the study will either receive the 6-20 session CBT intervention at the time of enrollment or 6 months after they enroll. Assessments including questions about eating behaviors, mood, and general functioning are given on enrollment in the study, and 3- and 6-months following enrollment (also at 9- and 12-months for those in the delayed treatment condition
16316901|NCT00522756|Drug|Sodium bicarbonate|Three ampoules of 7.5% sodium bicarbonate (89.3 mOsm/ampoule; total 150 ml for three ampoules) added to 750 ml of 5% dextrose in water, given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
16316902|NCT00522756|Drug|Sodium chloride|0.9% sodium chloride given at 1 ml/kg/hour through a dedicated intravenous line for 6 hours, and completed prior to the initiation of cardiopulmonary bypass.
16316903|NCT00522743|Drug|growth hormone and gonadotropin-releasing hormone agonist|GH & GNRHa treatment
16316904|NCT00522743|Drug|growth hormone|GH treatment
16316905|NCT00522730|Other|Parenteral nutrition|Duration : 5 days
16316906|NCT00522730|Other|Enteral nutrition|Duration : 5 days
16316907|NCT00522717|Behavioral|Cognitive Behavioral Therapy (CBT)|Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
16316908|NCT00522717|Behavioral|Usual Care|Subjects receive Usual Care for 8 weeks followed by CBT
16316909|NCT00522704|Other|Dynamic Arterial line Pressure (DALP)|eEBF will be record with dynamic arterial line pressure of -60 mmHg (eEBF-60 mmHg), -100 mmHg (eEBF-100 mmHg), -160 mmHg (eEBF-160 mmHg), -200 mmHg (eEBF-200 mmHg) and -260 mmHg (eEBF-260 mmHg) during the first one half hour of the dialysis session. Access Blood flow will be performed with blood thermal monitor.
16316910|NCT00522691|Procedure|sacral nerve stimulation|sacral nerve stimulation for fecal incontinence
16316911|NCT00522678|Drug|GW685698X|Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS
16316912|NCT00522678|Drug|Placebo|Subject will receive Placebo matching GW685698X via DISKUS.
16316913|NCT00522665|Drug|Irinotecan|Irinotecan 125 mg/m2 IV days 1 and 8
16316914|NCT00522665|Biological|Cetuximab|Cetuximab 250mg/m2 IV days 1, 8 and 15
16316915|NCT00522665|Biological|RAD001|Patients on Arm A will crossover and receive RAD001 at disease progression
16316916|NCT00522652|Drug|PX-478|Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity
16316917|NCT00522639|Other|18F-deoxyglucose (FDG)|contrast medium
16316918|NCT00522626|Device|Maternal fetal monitoring|Simultaneous monitoring of maternal and fetal physiology
16316919|NCT00522613|Behavioral|Recovery Group Project|Recovery Group Workbook & Group Sessions
16316920|NCT00522587|Drug|Fixed sevoflurane dose 1|Dose 1 of sevoflurane
16316921|NCT00522587|Drug|Fixed sevoflurane dose 2|Dose 2 of sevoflurane
16316922|NCT00522587|Drug|Fixed sevoflurane dose 3|Dose 3 of sevoflurane
16316923|NCT00522587|Drug|Fixed sevoflurane dose 4|Dose 4 of sevoflurane
16316924|NCT00522587|Drug|Fixed sevoflurane dose 5|Dose 5 of sevoflurane
16316925|NCT00522587|Drug|Fixed sevoflurane dose 6|Dose 6 of sevoflurane
16316926|NCT00522587|Drug|Fixed remifentanil dose 1|Dose 1 of remifentanil
16316927|NCT00522587|Drug|Fixed remifentanil dose 2|Dose 2 of remifentanil
16316928|NCT00522587|Drug|Fixed remifentanil dose 3|Dose 3 of remifentanil
16316929|NCT00522587|Drug|Fixed remifentanil dose 4|Dose 4 of remifentanil
16316930|NCT00522587|Drug|Fixed remifentanil dose 5|Dose 5 of remifentanil
16316931|NCT00522587|Drug|Fixed remifentanil dose 6|Dose 6 of remifentanil
16316932|NCT00522574|Drug|XL019|gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths
16316933|NCT00522561|Other|energetic and non invasive limb mechanical measurements|Force velocity stiffness running
16316934|NCT00522548|Drug|Enteric coated mycophenolate sodium|Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
16316935|NCT00522548|Drug|Mycophenolate mofetil|Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
16316938|NCT00522509|Drug|Floxuridine FUDR|
16316939|NCT00522470|Drug|rosiglitazone|
16316940|NCT00522457|Drug|ertumaxomab|Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.
16316941|NCT00522444|Drug|Nebulized Magnesium Sulfate|6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
16316942|NCT00522444|Other|Nebulized normal saline|standard of care
16316943|NCT00522431|Drug|Testosterone|2% gel
16316944|NCT00522418|Device|Vagal Nerve Simulation (VNS) Therapy|VNS Therapy + Best Medical Practice including anti-epileptic drugs
16316945|NCT00522418|Drug|Best Medical Practive|Best Medical Practice including anti-Epileptic Drugs
16316988|NCT00522106|Behavioral|Behavioral graded activity|The intervention is directed at increasing the level of activities in a time-contingent way, with the goal to integrate these activities in the daily living of the patients. The intervention is performed by physical therapists in primary care, on individual basis. Treatment period of maximal 12 weeks (with maximal 18 sessions), followed by 5 pre-set boostermoments with a maximum of 7 sessions (respectively in week 18, 25, 34, 42, and 55).
16317084|NCT00521248|Drug|Oral morphine solution|0.4 mg/kg/day morphine every 4 hours
16317085|NCT00521222|Drug|Fluticasone with salmeterol|Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
16316946|NCT00522405|Procedure|TACE|"Under local anesthesia, the Femoral artery would be punctured
~A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency
~Superselective catheterization of the hepatic artery feeding the tumor would be done
~By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered.
~Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture.
~The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way.
~Gelfoam particles would be injected following this for embolization"
16316947|NCT00522392|Drug|bortezomib|Given IV
16316948|NCT00522392|Drug|lenalidomide|Given PO
16316949|NCT00522392|Drug|dexamethasone|Given PO
16316950|NCT00522379|Drug|Rotigotine|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
16316951|NCT00522379|Drug|Rotigotine|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
16316952|NCT00522379|Other|Placebo|Placebo transdermal patch applied daily
16316953|NCT00522379|Drug|Rotigotine|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
16316954|NCT00522379|Drug|Rotigotine|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
16316955|NCT00522353|Dietary Supplement|Oligofructose|21 grams per day in distributed over 3 doses per day for 3 months
16316956|NCT00522353|Dietary Supplement|Placebo|7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
16316957|NCT00522340|Behavioral|Aerobic Exercise Program|Home walking 1 hour a day for 5 days/week for 8 weeks. Then 30 minutes a day on all or most days of the week.
16316958|NCT00522327|Other|remote simultaneous medical interpreting|remote simultaneous medical interpretation
16316959|NCT00522327|Other|usual and customary|usual and customary interpreting
16316960|NCT00522327|Other|ENglish speaking|English speakers
16316961|NCT00522314|Device|NIV and ACBT|
16316962|NCT00522314|Other|Active Cycle of Breathing Techniques|
16316963|NCT00522301|Drug|sorafenib tosylate|
16316964|NCT00522301|Other|immunoenzyme technique|
16316965|NCT00522301|Other|immunohistochemistry staining method|
16316966|NCT00522301|Other|laboratory biomarker analysis|
16316967|NCT00522301|Other|pharmacological study|
16316968|NCT00522288|Device|Soft contact lenses|Daily wear soft contact lenses disposed of daily or biweekly
16316969|NCT00522288|Device|Spectacle|Spectacles for the treatment of myopia
16316970|NCT00522275|Drug|lacosamide|50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
16316971|NCT00522262|Behavioral|Aerobic exercise intervention|Women in the exercise arm underwent a year-long exercise intervention of five days per week of 45 minutes/session of moderate-vigorous intensity aerobic exercise.
16316972|NCT00522249|Drug|Pegylated Alfa Interferon|Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level.
16316973|NCT00522249|Drug|sunitinib|Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level.
16316974|NCT00522249|Drug|erlotinib|Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration.
16316975|NCT00522236|Biological|Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008|"A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:
~A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
~A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
~B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.
~The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.
~A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm."
16316976|NCT00522223|Behavioral|Questionnaire|"Participants who are treated with radiation therapy: Questionnaires 5 times.
~Participants who undergo a radical hysterectomy: Questionnaires 4 times."
16316977|NCT00522210|Drug|Detemir|Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.
16316978|NCT00522210|Other|Novolin NPH or Humulin N|Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.
16316979|NCT00522197|Dietary Supplement|multi-herbal agent ACAPHA|
16316980|NCT00522197|Dietary Supplement|Sugar Pill|
16316981|NCT00522184|Procedure|intra-articular injection of etanercept|
16316982|NCT00522184|Procedure|intra-articular injection of steroid|
16316983|NCT00522171|Device|The Harmonic™ ultrasonic scalpel|A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
16316984|NCT00522158|Drug|simvastatin|
16316985|NCT00522158|Drug|atorvastatin|
16316986|NCT00522145|Drug|XL647|Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets
16316987|NCT00522132|Drug|Artesunate|intravenous application
16317037|NCT00521664|Biological|Therapeutic platelet transfusion|In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.
16317038|NCT00521638|Biological|TRU-015|Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks
16316989|NCT00522106|Other|Exercise therapy|Treatment according to the Dutch physiotherapy guideline for patients with osteoarthritis of hip and/or knee. This guideline consists of general recommendations, emphasizing provision of information and advice, exercise therapy, and encouragement of a positive coping with the complaints. The treatment consisted of a maximum of 18 sessions within a period of 12 weeks. The treatment could be discontinued within the 12 week period if, according to the physiotherapists, all treatment goals were achieved.
16316990|NCT00522093|Drug|TJ-100|TJ-100 2.5g three times per day for 6 weeks
16316991|NCT00522067|Biological|Adjuvanted influenza vaccine|Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine
16316992|NCT00522054|Other|Physical exercise|Tai Chi exercise, twice a week during 12 weeks
16316993|NCT00522041|Drug|Cellegesic|Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.
16316994|NCT00522041|Drug|Placebo|Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.
16316995|NCT00522015|Drug|rivastigmine|rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
16316996|NCT00521989|Drug|CRx-102 (2.7/90)|CRx-102 dose 1
16316997|NCT00521989|Drug|Prednisolone|Prednisolone
16316998|NCT00521989|Drug|Placebo|Placebo
16316999|NCT00521989|Drug|CRx-102 (2.7/180)|CRx-102 dose 2
16317000|NCT00521989|Drug|CRx-102 (2.7/360)|CRx-102 dose 3
16317001|NCT00521963|Biological|Intraarticular injection of infliximab|A single injection of 100 mg of infliximab
16317002|NCT00521950|Genetic|TPMT genotyping; Drug: azathioprine or 6-mercaptopurine|"Assessment of the polymorphisms G238C, G460A, and A719G in a venous blood sample to identify functional genetic variants (TPMT*2, *3A, *3C) of the TPMT gene (chromosome 6) associated with reduced or negligible TPMT enzyme activity.
~Patients are advised an initial treatment dose based on the enzyme activity:
~Normal: AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);
~Reduced: AZA 1-1.25 mg/kg/day or 6-MP 0.5-0.75 mg/kg/day;
~Negligible: AZA 0-0.2 mg/kg/day or 6-MP 0-0.1 mg/kg/day;"
16317003|NCT00521950|Drug|azathioprine (AZA) or 6-mercaptopurine (6-MP)|"Patients will be advised a standard initial treatment dose:
~AZA 2-2.5 mg/kg/day or 6-MP 1-1.5 mg/kg/day (standard care);"
16317004|NCT00521937|Other|Dermagen®|Weekly topical applications
16317005|NCT00521924|Biological|infliximab|infliximab 3 mg/kg and basic treatment
16317006|NCT00521924|Drug|DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.|Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89
16317007|NCT00521911|Behavioral|Cognitive Behavioural Therapy|
16317008|NCT00521898|Procedure|Descemet Membrane Endothelial Keratoplasty (DMEK)|
16317011|NCT00521872|Procedure|STARR Operation|
16317012|NCT00521859|Drug|Cloretazine|800 mg/m^2 by vein daily
16317013|NCT00521859|Drug|Fludarabine|25 mg/m^2 by vein daily x 5 Days
16317014|NCT00521846|Device|Biomet Explor Modular Radial Head Replacement|As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.
16317015|NCT00521833|Procedure|phacoemulsification and intraocular lens implantation|clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively
16317016|NCT00521820|Drug|Pioglitazone|Pioglitazone 30 mg (titrated to 45mg with tolerance), tablets, orally once daily and glyburide placebo-matching tablets, orally, once daily for up to 24 weeks.
16317017|NCT00521820|Drug|Glyburide|Pioglitazone placebo-matching tablets, orally, once daily and glyburide 10 mg (titrated to 15mg with tolerance), capsules, orally, once daily for up to 24 weeks.
16317018|NCT00521807|Procedure|Hypnosis|a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week,
16317019|NCT00521781|Drug|Abraxane|100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)
16317020|NCT00521781|Drug|Leuprolide|7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years
16317021|NCT00521781|Drug|Bicalutamide|50 mg p.o. daily starts week 36 of initiating Abraxane.
16317022|NCT00521768|Behavioral|Prolonged exposure|
16317023|NCT00521755|Device|Seraffix LTB|laser soldering for soft tissue wounds
16317024|NCT00521742|Drug|Pioglitazone|Pioglitazone 15 mg to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 52 weeks.
16317025|NCT00521742|Drug|Glyburide|Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
16317026|NCT00521742|Drug|Pioglitazone|Pioglitazone 15 mg or 30 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally once daily for up to 52 weeks.
16317027|NCT00521742|Drug|Glyburide|Glyburide 5 mg or 10 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally once daily for up to 52 weeks.
16317028|NCT00521729|Procedure|Exposure to Cold Temperature|
16317029|NCT00521716|Device|Intracapsular Femoral Fracture Fixation|The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
16317030|NCT00521716|Device|WaisFix100i for Intracapsular Femoral Fracture Fixation|The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
16317031|NCT00521703|Drug|Lidocaine|oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing
16317032|NCT00521703|Drug|Tannic acid|oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
16317033|NCT00521690|Drug|insulin detemir|
16317034|NCT00521677|Procedure|Sage oral care|Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
16317035|NCT00521677|Procedure|Traditional oral care|Cleaning of oral cavity with menthol solution, TID
16317036|NCT00521664|Biological|Prophylactic platelet transfusion|In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.
16317039|NCT00521612|Drug|sevoflurane|Volatile anaesthetic sevoflurane 1 MAC (2,0 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic sevoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic sevoflurane. Change will be +10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
16317040|NCT00521612|Drug|isoflurane|Volatile anaesthetic isoflurane 1 MAC (1,2 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic isoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic isoflurane. Change will be +10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
16317041|NCT00521599|Drug|Mometasone furoate dry powder inhaler|
16317042|NCT00521599|Drug|Placebo|
16317043|NCT00521586|Biological|13 valent pneumococcal conjugate vaccine|TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
16317044|NCT00521586|Biological|13 valent pneumococcal conjugate vaccine|TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
16317045|NCT00521573|Other|Dark chocolate|
16317046|NCT00521560|Drug|Zevalin|"All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively.
~High dose therapy will be given as BEAM"
16317047|NCT00521547|Procedure|Electroacupuncture|
16317048|NCT00521534|Device|CRT with atrial overdrive pacing|Both groups receive CRT, one group receives atrial overdrive pacing
16317049|NCT00521521|Drug|docetaxel and cisplatin|
16317050|NCT00521521|Drug|docetaxel|
16317051|NCT00521508|Procedure|gene transcription and cytometry|samply of 30 ml of blood
16317052|NCT00521495|Device|neodymium permanent magnet|"3/4 diameter by 1/8 thick permanent magnet"
16317053|NCT00521495|Device|neodymium magnet|A. 450 Gauss static magnetic field at target B. 150 Gauss static magnetic field at target C. 0 Gauss static magnetic field at target
16317054|NCT00521495|Device|magnet|0 Gauss magnets are worn every night during hours of sleep for 6 weeks.
16317055|NCT00521482|Drug|Temozolomide|
16317056|NCT00521482|Drug|Temozolomide plus Thalidomide|
16317057|NCT00521469|Device|Pro Adjuster|
16317058|NCT00521456|Drug|ketorolac eye drops|"1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day
~Placebo"
16317059|NCT00521443|Procedure|Cryopreservation, thawing and blastocyst culture|Good quality human embryos were frozen - thawed and cultured to the blastocyst stage.
16317060|NCT00521430|Biological|anti-thymocyte globulin|
16317061|NCT00521430|Drug|busulfan|
16317062|NCT00521430|Drug|cyclosporine|
16317063|NCT00521430|Drug|fludarabine phosphate|
16317064|NCT00521430|Drug|methotrexate|
16317065|NCT00521430|Drug|methylprednisolone|
16317066|NCT00521430|Procedure|allogeneic hematopoietic stem cell transplantation|
16317067|NCT00521430|Procedure|peripheral blood stem cell transplantation|
16317068|NCT00521417|Behavioral|short-term dynamic therapy|
16317069|NCT00521417|Behavioral|long-term dynamic therapy|
16317070|NCT00521404|Drug|CS-1008 (humanized anti-DR5 antibody)|CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
16317071|NCT00521404|Drug|gemcitabine|Gemcitabine - 1000mg/meter sq
16317072|NCT00521391|Other|Allez Hop|a tailored physical activity intervention involving moderate-intensity exercise
16317073|NCT00521365|Drug|Quetiapine 600mg|"300 mg quetiapine fumarate tablets for oral use.
~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day."
16317074|NCT00521352|Device|Active Repetitive Transcranial Magnetic Stimulation (rTMS)|Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks.
16317075|NCT00521352|Device|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain.
16317076|NCT00521339|Drug|Apremilast|20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.
16317077|NCT00521300|Drug|Octreotide|First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months
16317078|NCT00521300|Procedure|Direct surgery for acromegaly|Direct transsphenoidal surgery
16317079|NCT00521287|Other|Immune profiling and DC vaccine|"For observational study (immune profiling): blood sampling 3-5 mL
~For DC vaccine: one dose of DC vaccine(~10 million cells)/2 week for at least 6 month or until progression."
16317080|NCT00521274|Biological|MVA 5T4|Docetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration.
16317081|NCT00521274|Drug|Docetaxel|Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration.
16317082|NCT00521261|Biological|anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells|
16317083|NCT00521248|Drug|buprenorphine|sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
16317086|NCT00521222|Drug|Fluticasone HFA|Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
16317087|NCT00521209|Behavioral|Self-Care Stimulating Disease Prevention Program (SCSDPP)|"The SCSDPP development is guided by the following premises: a) patient-directed lifestyle change or self-prescription of behavior change is potentially a more empowering, sustainable, and proactive approach to addressing personal health habits than the more conventional physician-directed approach; b) patient-directed lifestyle change or self-prescription of behavior change is potentially an important predictor of self-efficacy and long-term adherence to healthy habits; c) behavior change in isolation is less sustainable than change that is reinforced by other distinct but related changes (e.g., the potential synergy of improving diet and physical activity concurrently to prevent chronic disease); d) a multi-level change directed at the service delivery system and physician support, however small, has the added benefit of potentially reducing provider and staff burden while maximizing available clinic and community resources; and f) brief physician counseling"
16317088|NCT00521209|Other|Stand procedures, no intervention|
16317089|NCT00521196|Device|DC Stimulator (Transcranial Direct Current Stimulator)|Subjects will receive a total of 10 sessions of either active tDCS or sham tDCS over a four-week period (administered every other day during weekdays over the course of one month). During each tDCS session, two electrodes are placed over selected areas of the brain. The anode is placed on the motor cortex contralateral to the side where migraines predominant; the cathode is placed near the supraorbital area, opposite the anode. A small battery powered device drives 2 mA of direct current through the two electrodes. The direct current will flow through the electrodes, penetrate the scalp, and create a flow of electrical current in the brain. The procedure will last 20 minutes. For sham tDCS, an alternate method of stimulation will be used.
16317090|NCT00521183|Drug|Cytochlor|The study's starting dose of CldC is 50 mg/m2/day. The dose of CldC will be escalated / de-escalated for patients. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
16317091|NCT00521183|Drug|Tetrahydrouridine|A fixed dose of H4U at 720 mg/m2/day will be used, regardless of the dose of CldC administered. H4U will be delivered by an IV bolus infusion over a period of 5 minutes, followed 5 minutes later by an IV bolus infusion of CldC. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
16317092|NCT00521183|Radiation|Radiation Therapy|One treatment of 3 Gy will be given daily 5 days per week (10 fractions) for a total of 30 Gy over two weeks.
16317093|NCT00521170|Drug|Levocetirizine|
16317094|NCT00521157|Drug|Go Medical Naltrexone implants|Naltrexone implants 3.2 g (double of 1,6 g)
16317095|NCT00521144|Drug|obatoclax mesylate|Given IV
16317096|NCT00521144|Drug|topotecan hydrochloride|Given IV
16317097|NCT00521144|Other|laboratory biomarker analysis|Correlative studies
16317098|NCT00521131|Drug|Levocetirizine dihydrochloride|
16317099|NCT00521118|Other|Laboratory Biomarker Analysis|Correlative studies
16317100|NCT00521118|Procedure|Therapeutic Conventional Surgery|Undergo second curettage
16317101|NCT00521105|Other|Virtual visit|Participants will alternate between a multidisciplinary visit (MD, RN and RD) and a phone contact with the diabetes nurse educator (the phone contact will replace the physician-only visit). Prior to the phone contact, transmission of information from the participant will be sent through either fax or a web browser.
16317102|NCT00521092|Drug|sunitinib malate|Given orally
16317103|NCT00521092|Procedure|laboratory biomarker analysis|Correlative study
16317104|NCT00521092|Procedure|pharmacological study|Correlative study
16317105|NCT00521079|Device|Therapy ON|Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)
16317106|NCT00521079|Device|Therapy OFF|Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)
16317107|NCT00521066|Device|GYNECARE PROSIMA* Pelvic Floor Repair System|procedure for pelvic organ prolapse
16317108|NCT00521053|Drug|PV-10 (10% rose bengal disodium)|Intralesional injection for chemoablation
16317109|NCT00521040|Drug|Levocetirizine dihydrochloride|
16317110|NCT00521027|Device|Versajet Hydrosurgery System|Debridement with Versajet Hydrosurgery System
16317111|NCT00521027|Procedure|Conventional surgical debridement techniques|Conventional surgical debridement with scalpel and pulse lavage
16317112|NCT00521014|Biological|filgrastim|
16317113|NCT00521014|Biological|rituximab|
16317114|NCT00521014|Biological|sargramostim|
16317115|NCT00521014|Drug|carmustine|
16317116|NCT00521014|Drug|cytarabine|
16317117|NCT00521014|Drug|etoposide|
16317118|NCT00521014|Drug|melphalan|
16317119|NCT00521014|Procedure|autologous hematopoietic stem cell transplantation|
16317120|NCT00521001|Drug|everolimus|
16317121|NCT00521001|Drug|temozolomide|
16317122|NCT00520988|Behavioral|Use of telephone-based Interactive Voice Recognition system|Use of telephone-based Interactive Voice Recognition system, for reporting of health information and blood pressure measurements
16317123|NCT00520975|Biological|Bevacizumab|Given IV
16317124|NCT00520975|Drug|Carboplatin|Given IV
16317125|NCT00520975|Drug|Paclitaxel|Given IV
16317126|NCT00520975|Other|Placebo|Given IV
16317127|NCT00520975|Biological|Trastuzumab|Given IV
16317128|NCT00520949|Drug|Augmentin (Amoxicillin-clavulanic)|Amoxicillin-clavulanic acid 1 gram b.i.d
16317129|NCT00520949|Drug|Furoxone (furazolidone)|furazolidone 200 mg b.i.d
16317130|NCT00520949|Drug|Cebes (colloidal bismuth subcitrate)|colloidal bismuth subcitrate 240 mg b.i.d
16317131|NCT00520949|Drug|Esso (esomeprazole)|esomeprazole 40 mg b.i.d for 14 days
16317224|NCT00520338|Drug|celecoxib|"placebo
~celecoxib 400 mg oral single dose"
16318991|NCT00507091|Drug|Irinotecan|intravenous infusion
16317132|NCT00520936|Drug|pemetrexed|1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles
16317133|NCT00520923|Drug|LY2140023|80mg, PO (by mouth) BID (twice a day) for up to 4 weeks.
16317134|NCT00520923|Drug|LY2140023|40mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
16317135|NCT00520923|Drug|LY2140023|20mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
16317136|NCT00520923|Drug|LY2140023|5mg, PO (by mouth) BID (twice daily) for up to 4 weeks.
16317137|NCT00520923|Drug|Olanzapine|10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks.
16317138|NCT00520923|Drug|Placebo|Taken PO (by mouth) QAM (every morning) for up to 4 weeks.
16317139|NCT00520923|Drug|Placebo|Taken PO (by mouth) BID (twice daily) for up to 4 weeks.
16317140|NCT00520910|Drug|Polypodium leucotomos|Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.
16317141|NCT00520897|Drug|Raltegravir (MK0518)|400mg BID; 48 weeks
16317142|NCT00520897|Drug|Placebo|400mg QD
16317143|NCT00520897|Procedure|Leukopheresis|pack of cells as per protocol
16317144|NCT00520897|Procedure|Sigmoid Biopsy|gut samples as per protocol
16317145|NCT00520884|Drug|Ghrelin Infusion - Healthy|At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
16317146|NCT00520884|Drug|Ghrelin Infusion - Frail|At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
16317147|NCT00520884|Other|Placebo Infusion -Healthy|At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
16317148|NCT00520884|Other|Placebo Infusion - Frail|At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
16317149|NCT00520871|Drug|Blueberry juice|
16317150|NCT00520858|Other|Resistance Exercise (RE)|
16317151|NCT00520858|Other|Aerobic Exercise (AE)|
16317152|NCT00520858|Other|Resistance and Aerobic Exercise (RAE)|
16317153|NCT00520845|Drug|celecoxib|600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.
16317154|NCT00520845|Drug|Docetaxel|75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle
16317155|NCT00520845|Drug|pemetrexed disodium|500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.
16317156|NCT00520845|Other|laboratory biomarker analysis|Blood collection
16317157|NCT00520832|Device|Microcurrent|20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
16317158|NCT00520832|Device|Microcurrent|Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
16317159|NCT00520819|Drug|Antioxidant-rich food items|
16317160|NCT00520806|Drug|Relaxin|Intravenous infusion for 48 h at 30 ug/kg/day
16317161|NCT00520806|Drug|Placebo|Intravenous infusion for 48 h
16317162|NCT00520780|Drug|Ferinject ® (Ferric carboxymaltose)|"Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.
~After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase)."
16317163|NCT00520780|Drug|Normal saline (0.9%)|During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
16317164|NCT00520767|Drug|bortezomib|Bortezomib 1.3 mg/m2 days 1, 8, 15, 22
16317165|NCT00520767|Drug|dexamethasone|Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23
16317166|NCT00520767|Drug|melphalan|Melphalan 9 mg/m2/day days 1-4
16317167|NCT00520767|Genetic|microarray analysis|≤28 days prior to enrollment
16317168|NCT00520767|Other|flow cytometry|Day 1 of cycles 6, 12, 18 and at end of study.
16317169|NCT00520767|Other|laboratory biomarker analysis|≤28 days prior to enrollment
16317170|NCT00520767|Procedure|quality-of-life assessment|Start of each cycle
16317171|NCT00520754|Drug|levocetirizine dihydrochloride|
16317172|NCT00520741|Drug|Lacosamide|50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
16317173|NCT00520741|Drug|Lacosamide|50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
16317174|NCT00520728|Behavioral|Occupational Time Use Intervention|12 week behavioral intervention administered by Occupational Therapists.
16317175|NCT00520702|Procedure|Intensity Modulated Radiation Therapy|66 Gy in 33 Daily Fractions at 2 Gy per fraction.
16317176|NCT00520702|Procedure|3-Dimensional Conformal Radiation Therapy|66 Gy in 33 Daily Fractions at 2 Gy per fraction.
16317177|NCT00520689|Device|Silicone Hydrogel Contact Lens|use of lens over 2 days
16317178|NCT00520676|Drug|pemetrexed|500 mg/m^2, IV, q 21 days x 6 cycles maximum
16317179|NCT00520676|Drug|docetaxel|75 mg/m^2, IV, q 21 days x 6 cycles maximum
16317180|NCT00520676|Drug|carboplatin|AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
16317181|NCT00520663|Drug|14C-SB649868|SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.
16317182|NCT00520650|Drug|Aripiprazole|
16317183|NCT00520637|Drug|EZN-2208|
16317184|NCT00520624|Device|inspiratory muscle strength training|
16317185|NCT00520624|Procedure|Surgery|
16317370|NCT00519233|Drug|AGS-1C4D4|IV
16317186|NCT00520611|Behavioral|Financial Incentives|Participants call in their weight on daily basis. Participants must report under their daily targets to qualify for entry into lottery. Call-in weights are verified at monthly weigh-ins.
16317187|NCT00520611|Behavioral|Financial Incentives|Participants call in their weight on daily basis. Participants must report under their daily targets to qualify to receive daily incentive. Call-in weights are verified at monthly weigh-ins.
16317188|NCT00520598|Biological|Comparator: V505 formulation 1|0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
16317189|NCT00520598|Drug|Comparator: V505 formulation 2|0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
16317190|NCT00520598|Drug|Comparator: V505 formulation 2|0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
16317191|NCT00520598|Biological|Comparator: V505 formulation 3|0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
16317192|NCT00520598|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant|0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
16317193|NCT00520598|Biological|Comparator: Placebo (unspecified)|0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
16317194|NCT00520585|Drug|atorvastatin|atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo
16317195|NCT00520572|Drug|AZD9056|
16317196|NCT00520572|Drug|Etanercept|
16317197|NCT00520572|Drug|Placebo|
16317198|NCT00520546|Other|18F-Ethylcholine Positron Emission Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. After a short gap due to computer processing time the whole body scan was performed starting at the upper thoracic aperture down to the proximal femur. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
16317199|NCT00520546|Other|Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2w spin echo (SE) sagittal, transversal and coronal sequences were acquired.
16317200|NCT00520533|Biological|Chimeric monoclonal antibody cG250|"First Cycle: cG250 10 mg/m² intravenous infusion, weekly for five weeks, followed by a two-week break. 1st & 5th dose will be trace-labeled with a radioactive substance detectable on a PET scanner (124I-cG250).
~Second cycle (investigator discretion): cG250 10 mg/m² intravenous infusion, weekly for four weeks followed by a two-week break. No 124I-cG250 will be used in the 2nd cycle.
~Up to 2 cycles available."
16317201|NCT00520533|Drug|Sunitinib malate|"First Cycle: Sunitinib 50 mg orally daily for 4 weeks (starts 8th day of 1st treatment cycle), followed by a two-week period off sunitinib.
~Second cycle (investigator discretion): Sunitinib 50 mg orally daily for 4 weeks (starts on 1st day of 2nd treatment cycle), followed by a two-week period off sunitinib.
~Up to 2 cycles available on-study."
16317202|NCT00520507|Drug|Olanzapine|Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
16317203|NCT00520507|Drug|Placebo|An inactive form of the treatment will be taken once daily at 6pm for 1 month.
16317204|NCT00520494|Drug|Vivaglobin|Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
16317205|NCT00520481|Drug|IMC-A12 (Cixutumumab)|10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks.
16317206|NCT00520468|Drug|Erythropoietin|40,000 units injected under the skin (SQ) weekly
16317207|NCT00520468|Drug|Cyclosporin A|300 mg (tablets) by mouth daily for 6 months
16317208|NCT00520468|Drug|G-CSF|300 mcg injected under the skin (SQ) two times per week
16317209|NCT00520468|Drug|Prednisone|60 mg per day for 7 days, taper over 1 month
16317210|NCT00520455|Drug|levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms|levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
16317211|NCT00520442|Drug|ibuprofen|
16317212|NCT00520442|Drug|acetamin w codeine|
16317213|NCT00520429|Behavioral|ACCES - Adjusting to Chronic Conditions with Education and Support|The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
16317214|NCT00520416|Procedure|Carbon dioxide angiogram|see description of procedure
16317215|NCT00520403|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
16317216|NCT00520403|Drug|Interferon alfa-2a|3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
16317217|NCT00520403|Drug|Vinblastine|0.1mg/kg iv every 3 weeks
16317218|NCT00520390|Drug|EZN-2208|
16317219|NCT00520377|Drug|MD05|recombinant human GDF-5 coated onto beta-tricalcium phosphate
16317220|NCT00520377|Device|Beta-TCP and autologous bone|beta-tricalcium phosphate and autologous bone
16317221|NCT00520364|Other|Observation of IVF outcomes in relation to chemo history and AMH|Women undergoing IVF with or without history of chemotherapy, AMH levels compared
16317222|NCT00520351|Drug|ClearCare|contact lens care system
16317223|NCT00520351|Drug|Optifree Replenish|contact lens care system
16317225|NCT00520325|Drug|Intravenous recombinant human mannose binding lectin|Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16317226|NCT00520325|Drug|Intravenous recombinant human mannose binding lectin|Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16317227|NCT00520299|Drug|ADI PEG 20|Intramuscular injections were administered into the deltoid, gluteal, or quadricep muscles once weekly (± 2 days) for 9 weeks during cycle 1 and 8 weeks during subsequent cycles
16317228|NCT00520286|Drug|Modafinil|200 mg or 400 mg /daily
16317229|NCT00520286|Drug|Placebo|Placebo / daily
16317230|NCT00520273|Device|cobas s 201 TaqScreen MPX Test|Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.
16317231|NCT00520260|Drug|bromfenac|0.09%, BID, 6 weeks
16317232|NCT00520260|Drug|ketorolac|0.4%, BID, 6 weeks
16317233|NCT00520247|Drug|enalapril plus folic acid|enalapril 10.0 mg daily for 8 weeks (the control group); enalapril 10.0 mg plus folic acid 0.4 mg daily for 8 weeks (Low-dose group); enalapril 10.0 mg plus folic acid 0.8 mg daily for 8 weeks (High-dose group)
16317234|NCT00520234|Drug|Caspofungin|50 mg IV daily
16317235|NCT00520234|Drug|Normal Saline|100 cc IV daily
16317236|NCT00520208|Drug|Tamibarotene|For induction therapy, tamibarotene will be self-administered via tablets on an outpatient basis at a dose of 6 mg/m2 per day, taken orally, in two divided doses approximately one hour after breakfast and dinner. Induction therapy will continue for a maximum of 56 days until either a morphologic leukemia-free state or complete response (CR) has been achieved. For patients who achieve a CR with induction therapy, consolidation therapy will commence 4 to 8 weeks after the end of induction therapy. For patients who have a morphologic leukemia-free state after induction therapy but who fail to achieve a CR, consolidation therapy will commence 8 weeks after the end of induction therapy.
16317237|NCT00520195|Behavioral|Physical activity|Climbing stairs instead of taking elevators at worksite during 12 weeks.
16317238|NCT00520182|Behavioral|MUFA diet|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). MUFA diet included only low glycemic index carbohydrates. The diet consisted of 35% carbohydrates and 45% fat (50% of them were mono-unsaturated fatty acids [MUFA]). Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
16317239|NCT00520182|Behavioral|ADA 2003|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). The carbohydrates are with mixed glycemic index. The diet contains 50-55% carbohydrates, 30% fat and 15-20% protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
16317240|NCT00520182|Behavioral|Low Glycemic index (LGI) diet|Patients were advised to consume 23 cal/kg/day. The diet contained sodium (up to 3000mg/day), potassium (more than 3000 mg/day), calcium (around 1300 mg/day) and magnesium (more than 800 mg/day). LGI diet included only low glycemic index carbohydrates. The diet consisted of 50-55% carbohydrates, 30% fat and 20%. protein. Participants were advised to eat 4-6 meals per day according to their lifestyle and to participate in 30-45 min of aerobic activity at least 3 days a week.
16317241|NCT00520169|Drug|intranasal ketamine|A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
16317242|NCT00520156|Device|Continuous positive airway pressure (CPAP)|Patients diagnosed with obstructive sleep apnea (OSA) will be offered standard of care treatment of CPAP (patients given oral appliances for OSA are excluded from our study). Note: our study is a survey-based and observational study following patients who are being evaluated for sleep disorders. Those patients diagnosed with OSA would be offered CPAP or possibly an oral appliance regardless of whether they are entered into our study or not.
16317243|NCT00520143|Biological|alglucosidase alfa (recombinant human acid alpha-glucosidase [rhGAA])|IV infusion: 20mg/kg qow
16317244|NCT00520130|Biological|Rituximab|Rituximab: 375 mg/m(2) intravenous (IV), day 1 for patients with cluster of differentiation 20 (CD20)-positive disease.
16317245|NCT00520130|Drug|Cyclosporine|Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if graft versus host disease (GVHD) does not develop.
16317246|NCT00520130|Drug|Allogenic stem cell transplant (ASCT)|Allogenic stem cell transplant
16317247|NCT00520130|Drug|Conditioning Chemotherapy|"Fludarabine:30 mg/m(2) per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3.
~Cyclophosphamide:1200 mg/m(2) per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m(2) per day IV infusion, Daily on days 6, -5,-4, and -3"
16317248|NCT00520130|Drug|TMS|Tacrolimus: starting day -3 before transplant, given initially at 0.02 mg/kg/day CIV. Continue IV and then switch to an equivalent oral dose (when patient taking po) titrated for a goal level of 5 to 10 ng/ml; Sirolimus: given as an initial loading dose of 12 mg p.o. on day -3 pre-transplant, 4 mg starting day -2 pre-transplant and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post-transplant. Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-transplant as tolerated.
16317249|NCT00520130|Drug|FLAG|Fludarabine:25 mg/m(2) per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m(2) IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day subcutaneous (SC) beginning 24 hours PRIOR to initiation of chemotherapy
16317250|NCT00520130|Drug|EPOCH-F|Fludarabine:25 mg/m(2) per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m(2) per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m(2)/day CIV, days 1-4 Vincristine:0.4 mg/m(2) per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide:750 mg/m(2) IV infusion over 30 minutes on day 5
16317251|NCT00520130|Biological|Alemtuzumab|Alemtuzumab:20 mg/day IV over 8 h on days 8 to 4 pre-transplant.
16317252|NCT00520104|Drug|intranasal ketamine|drug interaction
16317253|NCT00520091|Drug|CPT- 11|65mg/m2 given on days 1, 8 ,22 and 29 prior to surgery
16317254|NCT00520091|Drug|Cisplatin|Cisplatin 30mg/m2 will be administered on days 1, 8, 22 and 29 prior to surgery
16317255|NCT00520091|Drug|Celecoxib|400 mg, orally, twice per day beginning on day minus 3 and continue until the end of chemoradiation with CPT-11 and Cisplatin
16317256|NCT00520091|Radiation|Radiation|4,500 cGy in 180 cGy fractions 5 days per week, over a period of 5 weeks
16317257|NCT00520091|Procedure|Surgery|Surgery will occur prior to chemoradiation therapy for those patients with resectable disease
16317258|NCT00520065|Other|enteral nutritional formula|Meal glucose tolerance test
16317259|NCT00520065|Other|Diabetes specific enteral product|Meal Glucose tolerance test
16317260|NCT00520052|Drug|zoledronic acid|5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
16317261|NCT00520039|Procedure|osteopathic manipulative medicine (OMM)|At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
16317262|NCT00520026|Drug|lithium|
16317263|NCT00520026|Drug|placebo|
16317264|NCT00520013|Drug|bevacizumab|
16317265|NCT00520013|Drug|erlotinib|
16317266|NCT00520013|Drug|paclitaxel|
16317267|NCT00520013|Drug|carboplatin|
16317268|NCT00520000|Drug|Carboplatin|standard dose of area under the curve (AUC) AUC of 6 in all arms
16317269|NCT00520000|Drug|Abraxane|75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
16317270|NCT00520000|Drug|Abraxane|180mg/m2 - 340mg/m2, repeated every 21 days
16317271|NCT00520000|Drug|Abraxane|100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
16317272|NCT00519987|Drug|intranasal ketamine|intranasal ketamine
16317273|NCT00519974|Other|counseling intervention|
16317274|NCT00519974|Other|study of socioeconomic and demographic variables|
16317275|NCT00519974|Procedure|management of therapy complications|
16317276|NCT00519974|Procedure|psychosocial assessment and care|
16317277|NCT00519961|Device|Elecsys®proBNP|
16317278|NCT00519948|Drug|new MPS, opti-free express no rub MPS|
16317279|NCT00519935|Behavioral|Multisystemic Therapy|MST is an individualized approach that begins with a comprehensive, multi-informant assessment that allows for the development of treatment goals and interventions that are individually tailored for each family. Therapists draw upon a menu of evidenced-based interventions that include cognitive-behavioral therapy, parent training and behavioral family systems therapy.
16317280|NCT00519922|Other|Kinesthesia, Balance, and Agility (KBA) Exercise|"Participants will exercise three times per week 20 to 30 minutes per session. Agility/Active Range of Motion exercises provide warm-up, improve joint range-of-motion & agility, dynamic proprioception,functional strength & endurance.
~Kinesthesia & Balance Training will challenge the subject's proprioceptive and neuromuscular control mechanisms to adapt and stabilize the knee joints during dynamic ADL activities (walking, climbing, etc); improve static and dynamic balance and sense of stability & confidence in ADL activities.
~Soft pads will be used to progress some of the kinesthesia & balance challenge training. Thera-Band® balance pads at 3 levels of softness will be used. These balance pads allow both appropriate starting difficulty and progression of difficulty level (i.e., the softer the pad, the greater the difficulty). Subjects will demonstrate safe balance on a stable surface (i.e. one-footed standing on floor) prior to progressing to the first level of the soft pads."
16317281|NCT00519922|Other|Standard LE Strength Training|Standard therapeutic exercises for knee OA which are widely used. Body weight and Thera-Band® color coded elastic bands will be used as appropriate to provide resistance. Exercises will be progressed according to the individual participant's improvement. All training for the ST condition will be conducted on stable surfaces (e.g. standing on floor, sitting in chair, lying on floor). Exercises may include 4-direction straight leg lifts, heel slides, quad sets, internal & external hip rotation, heel raises, toe raises, knee extension, knee flexion, partial squats/wall slides, etc.
16317282|NCT00519909|Other|Dairy calcium|Diets with different content of calcium and fat
16317283|NCT00519896|Drug|sunitinib malate|Given PO
16317284|NCT00519883|Other|Exercise|
16317285|NCT00519883|Other|Supportive Care|
16317286|NCT00519870|Drug|nifedipine, losartan|I: nifedipine 30 mg/d II: losartan 50 mg/d
16317287|NCT00519870|Drug|losartan|II: losartan
16317288|NCT00519870|Drug|Nifedipine, losartan|I: nifedipine II: losartan
16317289|NCT00519857|Drug|Tibolone|1.25 mg p.o, once daily for 3 years
16317290|NCT00519857|Drug|Placebo|Tablet p.o, once daily for 3 years
16317291|NCT00519844|Drug|somatropin|
16317292|NCT00519831|Biological|cetuximab|400 mg/m² week 1,then 250 mg/m² weekly
16317293|NCT00519831|Drug|vinflunine|Vinflunine 320 mg/m² every 21 days
16317294|NCT00519818|Drug|Chronocort|Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration
16317295|NCT00519818|Drug|Cortef|Cortef 3 times daily(total dose 30 mg)for minimum of 7 days
16317296|NCT00519805|Drug|dalteparin|
16317297|NCT00519805|Procedure|quality-of-life assessment|
16317298|NCT00519792|Drug|Omega DUROS device|Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
16317299|NCT00519779|Dietary Supplement|omega-3 supplementation|2.5 g/day omega-3
16317300|NCT00519779|Dietary Supplement|Oral omega-3 fish oil placebo|to match experimental dosage
16317301|NCT00519753|Drug|Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)|One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
16317302|NCT00519740|Other|inhalative specific bronchial provocation with grass-pollen|
16317303|NCT00519727|Drug|ISIS 325568|"4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg
~Placebo: 0.9% Sodium Chloride"
16317304|NCT00519714|Dietary Supplement|1-Methylnicotinamide (1-MNA)|Following a 6-8-week placebo and dietary-controlled baseline period, 195 men and women will be randomized to receive placebo, 30 mg MNA or 90 mg MNA three times daily for twelve weeks.
16317305|NCT00519714|Dietary Supplement|Placebo|Placebo
16317306|NCT00519701|Drug|hydroxyurea|
16317307|NCT00519688|Drug|Thalidomide|100 mg, BID
16317308|NCT00519688|Drug|Tegafur/Uracil|125 mg/m2, based on tegafur, BID
16317309|NCT00519675|Drug|alitretinoin|
16318992|NCT00507091|Drug|5-Fluorouracil|intravenous infusion
16317310|NCT00519662|Drug|SNS-314|"Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15
~Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1"
16317311|NCT00519649|Biological|Engerix™-B Kinder|Intramuscular injection, 1 dose
16317312|NCT00519636|Drug|FPNS|fluticasone propionate nasal spray
16317313|NCT00519636|Drug|FFNS|fluticasone furoate nasal spray
16317314|NCT00519636|Drug|placebo FFNS|placebo nasal spray matching fluticasone furoate nasal spray
16317315|NCT00519636|Drug|placebo FPNS|placebo nasal spray matching fluticasone propionate nasal spray
16317316|NCT00519623|Other|PassPort(R) Transdermal Insulin Delivery System|The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
16317317|NCT00519610|Other|Chart Review|Patients' charts will be reviewed for relevant medical information.
16317318|NCT00519597|Device|ResMed S8 (Auto-CPAP)|AutoCPAP during sleep
16317319|NCT00519584|Drug|Ropivacaine|30 ml 0.5%
16317320|NCT00519584|Drug|dex|8 mg (2 ml)
16317321|NCT00519584|Drug|Bupivacaine|30 ml 0.5%
16317322|NCT00519584|Drug|Saline|0.9% saline; systemic and local
16317323|NCT00519571|Device|ImplantLock device|dental implant
16317324|NCT00519558|Drug|somatropin|
16317325|NCT00519545|Behavioral|Prayer|Data collection on physiological biomarkers
16317326|NCT00519532|Drug|Rotigotine|"Rotigotine transdermal patches:
~10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
~Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h"
16317327|NCT00519519|Drug|Omeprazole|intravenous 80mg bolus followed by 8mg / hr for 3 days
16317328|NCT00519506|Other|ThromboView|Radiopharmaceutical, single dose, of the diagnosis of venous thromboembolism
16317329|NCT00519493|Procedure|Suture|One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
16317330|NCT00519493|Device|Clozex|One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
16317331|NCT00519480|Drug|GSK189075|GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.
16317332|NCT00519480|Drug|Metformin|Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
16317333|NCT00519480|Drug|Placebo|Placebo will be available as an oral tablets.
16317334|NCT00519467|Drug|Chlorproguanil-dapsone-artesunate (CDA)|
16317335|NCT00519454|Other|Peripheral lab draws|100ml blood for analysis, taken no more than 4 times in one year.
16317336|NCT00519441|Other|pH study|All patients will have 48 hour pH study
16317337|NCT00519428|Drug|escitalopram|10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted
16317338|NCT00519428|Drug|bupropion extra long (XL)|150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted
16317339|NCT00519428|Drug|escitalopram + bupropion|same dosing schedule as for monotherapy
16317340|NCT00519415|Other|Tongue plate|A functional appliance use for maxillary protraction.It has two adams clasp and two C clasp to retained the appliance and long palatal plate in the canine area which cages the tongue and transfer the force of the tongue during physiological activity to the upper arch. It has posterior bite plate and middle screw for maxillary expansion.It should be used all the time except meal time and brushing the teeth,the acrylic appliance makes specifically for the patient.
16317341|NCT00519415|Other|Facemask|An extraoral appliance use for treatment of maxillary deficiency in growing patients.It takes anchorage from chin and forehead, it has removable intraoral appliance with hooks for elastics that exerted a force of 300 gr.It should be used 14 hours a day.
16317342|NCT00519402|Other|tonsillar examination and questionnaire completion|
16317343|NCT00519389|Biological|H5N1 VLP Vaccine|Two doses - Day 0 & Day 28
16317344|NCT00519389|Biological|Placebo|Two doses - Day 0 & Day 28
16317345|NCT00519376|Drug|GW642444M|drug
16317346|NCT00519376|Drug|GW642444H|drug
16317347|NCT00519376|Drug|placebo|
16317348|NCT00519363|Drug|atorvastatin|atorvastatin 40mg, given orally daily for 3 months.
16317349|NCT00519350|Procedure|Blood collection|In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation
16317350|NCT00519337|Drug|Ascorbic acid|Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days
16317351|NCT00519337|Drug|Placebo|Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days
16317352|NCT00519324|Drug|Everolimus|10 mg/day (2 tablets of 5 mg each)
16317353|NCT00519311|Behavioral|Health Intervention Package|CHAP and Ask Diary
16317354|NCT00519298|Drug|SAM-531|dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531
16317355|NCT00519298|Other|placebo|placebo
16317356|NCT00519298|Drug|Donepezil|dosage form: 5 mg encapsulated tablets one single dose of 5 mg.
16317357|NCT00519285|Drug|Aflibercept|"25 mg/ml solution
~6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle"
16317358|NCT00519285|Drug|Placebo (for aflibercept)|"Sterile aqueous buffered solution identical to aflibercept
~1-hour IV on Day 1 of each 3-Week cycle"
16317359|NCT00519285|Drug|Docetaxel|"Marketed formulation
~75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)"
16317360|NCT00519285|Drug|Prednisone or Prednisolone|"Marketed formulation
~5 mg twice daily PO from day 1 continuously"
16317361|NCT00519272|Behavioral|Questionnaire|Series of surveys to be completed at the time of diagnosis and within one month after completion of treatment, taking approximately 45 minutes each time.
16317362|NCT00519259|Drug|Lobeline|
16317363|NCT00519246|Drug|Saline|Saline 5 ml administrated intravenously
16317364|NCT00519246|Drug|Opioid|Butorphanol tartrate 1 mg i.v.
16317365|NCT00519246|Drug|Opioid|Butorphanol Tartrate 2 mg i.v.
16317366|NCT00519246|Drug|NSAID|Flurbiprofen Axetil 50 mg i.v.
16317367|NCT00519246|Drug|NSAID|Flurbiprofen Axetil 100 mg i.v.
16317368|NCT00519246|Drug|Opioid|Tramadol Hydrochloride 10 mg i.v.
16317369|NCT00519246|Drug|Opioid|Tramadol Hydrochloride 20 mg i.v.
16317371|NCT00519220|Other|Symptom questionnaire|Patients will answer questionnaires evaluating their symptoms of achalasia.
16317372|NCT00519207|Drug|Lidocaine|1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
16317373|NCT00519207|Drug|24% Sucrose Solution|2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
16317374|NCT00519194|Device|Epicor LP Cardiac Ablation System|Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
16317375|NCT00519194|Procedure|Surgical ablation of permanent AF|Concomitant AF ablation during mitral valve surgery
16317376|NCT00519181|Drug|Valproic Acid|Valproic acid by oral route (20mg/Kg/day) during one year.
16317377|NCT00519168|Procedure|Urine sample|Standard of care
16317378|NCT00519168|Device|Electrode sleep recorder|Standard of care
16317379|NCT00519168|Procedure|phlebotomy|Standard of care
16317380|NCT00519155|Drug|MD05 and open flap debridement|recombinant human GDF-5 coated onto ß-tricalcium phosphate
16317381|NCT00519155|Procedure|Open flap debridement|Open flap debridement alone
16317382|NCT00519142|Drug|placebo for mitiglinide|three times a day with meals
16317383|NCT00519142|Drug|mitiglinide|three times a day with meals
16317384|NCT00519142|Drug|mitiglinide|two times a day with meals
16317385|NCT00519129|Device|3D-imager|3D-imager vs fluoroscopy during coloscopy
16317386|NCT00519116|Drug|Rapamune® (Sirolimus)|
16317387|NCT00519116|Drug|Tacrolimus|
16317388|NCT00519116|Drug|Perioperative Corticosteroids|The corticosteroids use was left up to the investigators decision.
16317389|NCT00519103|Other|exercise|
16317390|NCT00519090|Drug|Imatinib|Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
16317391|NCT00519090|Drug|Nilotinib (AMN107)|Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
16317392|NCT00519077|Drug|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
16317393|NCT00519064|Biological|Adjuvanted influenza vaccine|
16317394|NCT00519051|Other|monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)|Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization
16317395|NCT00519038|Other|Clinical Pathways|Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams
16317396|NCT00519038|Other|Usual Care|Usual care is the current practice actually performed in the hospital
16317397|NCT00519012|Drug|Sertraline to Paroxetine|For subjects enrolled in this arm, sertraline will be initiated at 25mg, increased to 50mg on day 3, and maintained until day 14. If subjects show an early response (i.e. a 20% improvement in the MADRS total score from baseline) at week 2, sertraline will be continued and titrated at 50 - 100mg based on clinical judgment. On the other hand, if subjects fail to show an early response at week 2, they will be randomly divided into two groups. In one group, sertraline will be continued and titrated at 50 - 100mg, whereas in the other group sertraline will be switched to paroxetine. In this switching group, paroxetine will be started at 10mg on days 15 and 16, increased to 20mg on day 17, and further increased to 40mg by a weekly 10mg increase, while sertraline will be dosed at 25mg on day 15 and terminated on day 16.
16317398|NCT00519012|Drug|Paroxetine to Sertraline|Paroxetine will be initiated at 10mg, increased to 20mg on day 3, and maintained until day 14. If subjects show an early response (i.e. a 20% improvement in the MADRS total score from baseline) at week 2, paroxetine will be continued and titrated at 20 - 40mg based on clinical judgment. On the other hand, if subjects fail to show an early response at week 2, they will be randomly divided into two groups. In one group, paroxetine will be continued and titrated at 20 - 40mg, whereas in the other group paroxetine will be switched to sertraline. In this switching group, sertraline will be started at 25mg on days 15 and 16, increased to 50mg on day 17, and further increased to 100mg by a weekly 25mg increase, while paroxetine will be dosed at 10mg on day 15 and terminated on day 16.
16317399|NCT00518986|Drug|armodafinil|200 mg/day
16317400|NCT00518986|Drug|placebo|placebo
16317401|NCT00518973|Drug|Quetiapine|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
16317402|NCT00518973|Drug|Placebo|Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
16317403|NCT00518960|Drug|ProAlgaZyme|
16317404|NCT00518947|Drug|Lithium|Treatment with lithium carbonate was initiated at a dose of 900-1200 mg/day. Serum lithium levels were monitored twice weekly, and the dose was adjusted to attain target levels between 0.8 and 1.0 mmol/L by the end of week one, with subsequent levels as high as 1.4 mmol/L permitted if needed.
16317405|NCT00518947|Drug|verapamil|The initial dose of verapamil was 80 mg b.i.d., and this was raised by 80 mg/day every three days to a maximum of 480 mg/day, unless intolerable side effects were produced at a lower level, in which case the dose was maintained at the highest tolerated amount.
16317406|NCT00518947|Drug|verapamil plus lithium|
16317407|NCT00518934|Other|Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell|
16317408|NCT00518921|Drug|Capadenoson (BAY 68-4986)|1mg Capadenoson, double dummy
16317409|NCT00518921|Drug|Capadenoson (BAY 68-4986)|2mg Capadenoson, double dummy
16317410|NCT00518921|Drug|Capadenoson (BAY 68-4986)|4mg Capadenoson, double dummy
16317411|NCT00518921|Drug|Placebo|Placebo, double dummy
16317412|NCT00518908|Drug|Sevoflurane|3.2 Vol % for postconditioning
16317413|NCT00518895|Drug|dacarbazine plus Genasense|Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
16317414|NCT00518895|Drug|dacarbazine plus placebo|Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
16317415|NCT00518882|Drug|liraglutide|1.8 mg once daily for s.c. (under the skin) injection.
16317416|NCT00518882|Drug|exenatide|10 mcg twice daily for s.c. (under the skin) injection.
16317417|NCT00518869|Drug|PG2|500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.
16317418|NCT00518856|Other|Neonatal resuscitation protocol|training in neonatal resuscitation and sepsis identification early treatment
16317419|NCT00518856|Other|Standard of care|continued with current standard of care for birth attendants
16317420|NCT00518843|Behavioral|FBT-BN|Mobilizing parents to curtail binge eating and purging
16317421|NCT00518843|Behavioral|SPT|Supportive the individual patient to explore factors that might underlie the eating disorder
16317422|NCT00518830|Other|multi-component intervention|The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
16317423|NCT00518830|Other|Usual care|included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
16317424|NCT00518804|Behavioral|Functional Behavioural Skills Group and Parent Training|
16317425|NCT00518791|Other|Multidisciplinary Care|A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
16317426|NCT00518791|Other|Usual Care|No altered organisation of care
16317427|NCT00518765|Drug|Aliskiren|
16317428|NCT00518765|Drug|Aliskiren plus placebo|
16317429|NCT00518765|Drug|Aliskiren|
16317430|NCT00518765|Drug|Aliskiren plus placebo|
16317431|NCT00518752|Procedure|Standard Oral Care|Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
16317432|NCT00518752|Procedure|Comprehensive Oral Care|Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day
16317433|NCT00518739|Drug|MK2461|Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).
16317434|NCT00518726|Biological|Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008|seasonal influenza vaccine 15ug
16317435|NCT00518713|Drug|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
16317436|NCT00518713|Drug|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
16317437|NCT00518713|Drug|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
16317438|NCT00518713|Drug|Placebo|tablets; orally; daily for 15-18 weeks
16317439|NCT00518700|Other|new MPS|
16317440|NCT00518700|Other|RepleniSH|
16317441|NCT00518687|Biological|V710|0.5-mL single injection of V710 (60 µg)
16317442|NCT00518687|Biological|Placebo|0.5-mL single injection of matching placebo
16317443|NCT00518674|Procedure|local infiltration analgesia|local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)
16317444|NCT00518648|Other|Multifactorial fall prevention program|Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
16317445|NCT00518648|Other|Usual care|Usual care
16317446|NCT00518635|Drug|Nutropin|Nutropin 0.1 mg/day self-administered once a day
16317447|NCT00518622|Drug|Comparator: MK7009|Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
16317448|NCT00518622|Drug|Comparator: Placebo|MK7009 Placebo
16317449|NCT00518596|Dietary Supplement|Probiotic supplementation (Lactobacillus plantarum)|GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.
16317450|NCT00518583|Drug|Pegylated Liposomal Doxorubicin (Doxil)|Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
16317503|NCT00518180|Biological|Tdap Vaccine|One dose of vaccine administered intramuscularly
16318993|NCT00507091|Drug|Leucovorin|intravenous infusion
16317451|NCT00518570|Drug|Levetiracetam|Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months.
16317452|NCT00518557|Procedure|Transcatheter Arterial Chemoembolization|The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
16317453|NCT00518544|Drug|administration of hydroxyehtyl starch|colloid is administered during operation according to blood loss.
16317454|NCT00518531|Drug|alendronate|Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.
16317455|NCT00518531|Drug|denosumab|Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.
16317456|NCT00518518|Drug|Staloral 300|Staloral 300
16317457|NCT00518518|Drug|placebo|placebo
16317458|NCT00518505|Other|Symptom questionnaire|This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.
16317459|NCT00518492|Procedure|Blood Sampling|Blood draws at 6 and 12 months following end of 6108A1-500 trial.
16317460|NCT00518479|Drug|Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD|
16317461|NCT00518479|Drug|Valsartan 160mg OD; Moxonidine 400mcg OD|
16317462|NCT00518466|Drug|topiramate|25 mg modified-release capsules
16317463|NCT00518466|Drug|phentermine|7.5 mg immediate-release capsules
16317464|NCT00518466|Drug|topiramate|100 and 25 mg immediate-release tablets
16317465|NCT00518466|Drug|phentermine|37.5 and 7.5 mg immediate-release tablets
16317466|NCT00518453|Biological|Surface antigen inactivated influenza vaccine|1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
16317467|NCT00518427|Drug|Insulin Glargine|"Lantus (insulin glargine [rDNA origin] injection), individual dosing , subcutaneous injection, 100 IU/ml.
~Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment."
16317468|NCT00518414|Other|Marketed infant formula with DHA and ARA|
16317469|NCT00518414|Other|Milk-based infant formula with DHA and ARA|
16317470|NCT00518414|Other|Milk-based formula with DHA, ARA, prebiotics|
16317471|NCT00518401|Biological|Mesendo|Intramuscular injection of 0.5 cc per site of the combination stem cell mixture in approximately 40 different ischemic sites of the gastrocnemius area of the calf.
16317472|NCT00518388|Behavioral|Focus Group|Focus groups each lasting about 2 hours.
16317473|NCT00518388|Behavioral|Questionnaire|Questionnaire relating to your health practices and knowledge about cervical cancer and HPV.
16317474|NCT00518375|Drug|Rapamune® (Sirolimus)|
16317475|NCT00518375|Drug|Neoral® (Cyclosporine)|
16317476|NCT00518375|Drug|Corticosteroids|Left up to local practice but steroids are typically used perioperatively
16317477|NCT00518362|Drug|TW|TW,120 mg/d
16317478|NCT00518349|Device|Passive bending function|Colonoscope with a passive bending function
16317479|NCT00518349|Device|No passive bending function|Examination using standard colonoscope without passive bending function
16317480|NCT00518336|Procedure|Blood sampling|Blood sampling at Visit 3, 5 and 7.
16317481|NCT00518336|Procedure|Collection of cervical specimen|Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
16317482|NCT00518336|Biological|Cervarix|Three doses administered intramuscularly at 0, 1 and 6 months.
16317483|NCT00518323|Drug|Paliperidone ER|3 mg or 6 mg tablet once daily for 6 weeks
16317484|NCT00518323|Drug|Placebo|Once daily for 6 weeks
16317485|NCT00518323|Drug|Paliperidone ER|1.5 mg tablet once daily for 6 weeks
16317486|NCT00518323|Drug|Paliperidone ER|6 mg or 12 mg tablet once daily for 6 weeks
16317487|NCT00518310|Drug|Placebo|
16317488|NCT00518310|Drug|AZAPRED|The initial dose of prednisone will be 0.5 mg/kg/day for 4 weeks, then 0.25 mg/kg/day for 8 weeks. The dose will continue to decrease at a rate of 5 to 10 mg per week, to a dose of 0.25 or 0.125 mg/kg/day. Azathioprine will be given at a dose of 2-3 mg/kg/day (max 100 mg).
16317489|NCT00518297|Drug|Raltegravir|Tablet, Oral, 400 mg, twice daily for 5 Days
16317490|NCT00518297|Drug|Atazanavir|Capsule, Oral, 300 mg, twice daily for 7 Days
16317491|NCT00518297|Drug|Atazanavir + Raltegravir|Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
16317492|NCT00518284|Drug|Nanoparticle Paclitaxel|Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
16317493|NCT00518271|Drug|Rapamune® (Sirolimus)|
16317494|NCT00518271|Drug|Tacrolimus|
16317495|NCT00518271|Drug|Corticosteroids|Perioperative
16317496|NCT00518245|Drug|enoxaparin|Enoxaparin will be given subcutanteously at a dose of 1mg/kg every 12 hours for a minimum of 48 hours (4 doses) and a maximum of 8 days until a diagnostic / therapeutic procedure is performed, or at the discretion of the investigator.
16317497|NCT00518232|Drug|OROS-methylphenidate|
16317498|NCT00518219|Drug|TW|TW,120mg/d
16317499|NCT00518206|Biological|NY-ESO-1 ISCOMATRIX® vaccine|NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
16317500|NCT00518206|Drug|Cyclophosphamide|Cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
16317501|NCT00518193|Drug|ERBITUX|400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
16317502|NCT00518180|Biological|Novartis Meningococcal ACWY Conjugate Vaccine|One dose of vaccine administered intramuscularly
16317504|NCT00518180|Biological|Novartis Meningococcal ACWY Conjugate Vaccine|One dose of vaccine administered intramuscularly
16317505|NCT00518167|Behavioral|Intensive lifestyle counselling|"Individualized dietary and physical activity counselling aiming at
~weight reduction
~dietary fibre 15 g /1000 kcal or more
~energy proportion of dietary fat less than 30%
~energy proportion of saturated fat less than 10%
~moderate physical activity >30 minutes per day or 4 hours per week"
16317506|NCT00518154|Drug|Pyridostigmine tablets|Patients will take 30mg tid PO for 12 weeks
16317507|NCT00518141|Drug|Acetyl Salicylic Acid and Terbutalin|ASA 75 mg, Terbutalin 5mg
16317508|NCT00518128|Procedure|Surgical OSA treatment|uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
16317509|NCT00518128|Procedure|Positive Airway Pressure Therapy|Continuous positive airway pressure for treatment of obstructive sleep apnea
16317510|NCT00518115|Drug|Albiglutide (GSK716155) or exenatide|Albiglutide weekly subcutaneous injection or exenatide twice daily injection
16317511|NCT00518102|Drug|REGRANEX (becaplermin)|A cohort of REGRANEX (becaplermin) users (ie, patients treated with REGRANEX (becaplermin), a topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes).
16317512|NCT00518102|Other|REGRANEX (becaplermin) comparators|A cohort of REGRANEX (becaplermin) nonusers (ie, patients who are not treated with REGRANEX [becaplermin]) but are similar in characteristics to patients in the REGRANEX [becaplermin] user cohort)
16317513|NCT00518089|Drug|Gatifloxacin 0.5% eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
16317514|NCT00518089|Drug|placebo eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
16317515|NCT00518050|Behavioral|Focus group|"Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of:
~Screening, skin self-examination, sun protection, and other cancer preventive practices;
~Cognitive factors (knowledge, awareness, melanoma worry, and perceived risk) related to screening and sun protection practices; and,
~Impact of melanoma on quality of life, family relationships, and economic issues arising from treatment"
16317516|NCT00518050|Behavioral|Survey|History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors
16317517|NCT00518037|Behavioral|surveys|anxiety surveys
16317518|NCT00518024|Procedure|Repetitive Transcranial Magnetic Stimulation (rTMS)|Bilateral Theta Burst Stimulation
16317519|NCT00518011|Drug|Erlotinib|150 mg po daily
16317520|NCT00518011|Drug|Gemcitabine|As prescribed
16317521|NCT00517998|Drug|Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel|10 mL Hydrogel
16317522|NCT00517985|Drug|Duloxetine|During the current study, for a short period of time participants will receive a placebo (a pill that looks like the study drug but which does not contain any medication), although during the majority of the study, participants will be receiving the actual study medication (Duloxetine). The initial dose of Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per day. This study will be blinded, meaning that participants will not know whether they are taking placebo or the study drug. However, all subjects will receive duloxetine for the majority of the time they are enrolled in the trial. Investigators will know when subjects are receiving the placebo but in order to maintain the blinding of this study, the study staff will not be able to tell participants when they are taking placebo and when they are taking Duloxetine.
16317523|NCT00517972|Drug|Omacor (omega-3-acid ethyl esters)|
16317524|NCT00517959|Radiation|Stereotactic Conformal radiotherapy|SCRT
16317525|NCT00517959|Radiation|Conventional radiotherapy|
16317526|NCT00517946|Drug|pseudoephedrine hydrochloride|
16317527|NCT00517946|Drug|cetirizine hydrochloride|
16317528|NCT00517933|Drug|Sildenafil Citrate|Sildenafil citrate (20mg 3 times a day [TID] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)
16317529|NCT00517933|Other|Placebo|Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)
16317530|NCT00517920|Drug|ABT-869|0.25 mg/kg QD
16317531|NCT00517907|Drug|Preimplantation factor (PIF-1)|"The study will include 6 patients and will last for at least six months. The first three patients will receive PIF-1 (0.5 mg/kg/day for 14 days) by subcutaneous injection. The dosage in the next three patients may be increased to 1 mg/kg/day for 14 days.
~Patients will be treated serially: each patient will be followed for 2 weeks after cessation of PIF-1 administration before the next patient begins PIF-1 administration."
16317532|NCT00517894|Drug|CEOP/IMVP-Dexa chemotherapy|Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28
16317533|NCT00517881|Drug|Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)|Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
16317534|NCT00517868|Drug|URG101|Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
16317535|NCT00517868|Drug|Placebo|Liquid formulation without active URG101 drug components
16317536|NCT00517855|Biological|PRTX-100 (Staphylococcal protein A)|
16317537|NCT00517842|Drug|ViNeuro|
16317538|NCT00517829|Drug|Docetaxel|Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
16317539|NCT00517829|Drug|cetuximab|ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
16317540|NCT00517829|Drug|oxaliplatin|Eloxatin 130 mg/m2 IV over 2 hours
16317541|NCT00517816|Drug|RG1671|Administered iv at escalating doses (with a starting dose of 0.0015mg)
16317542|NCT00517803|Dietary Supplement|Probiotic Yogurt B: with various micronutrients|175g probiotic yogurt / day 25% RDA for each nutrient
16317543|NCT00517803|Dietary Supplement|Probiotic Yogurt A: Kaiser micronutrients|175g probiotic yogurt/ day 25% RDA for each nutrient
16317544|NCT00517803|Dietary Supplement|Probiotic yogurt C: with basic micronutrients|175g yogurt/ day 25% RDA for each nutrient
16317545|NCT00517803|Dietary Supplement|Probiotic Yogurt D: Placebo -- no added micronutrients|175g/day probiotic yogurt
16317546|NCT00517790|Drug|ABT-869 .25 mg/kg|Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
16317547|NCT00517790|Drug|ABT-869 0.10 mg/kg|Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
16317548|NCT00517777|Device|continuous positive airway pressure ventilation|nighttime
16317549|NCT00517777|Behavioral|dietary and life style recommendations|
16317550|NCT00517777|Behavioral|dietary and life style recommendations|
16317551|NCT00517764|Drug|escitalopram|Patients started on 20mg of escitalopram and this dose was increased based on tolerability and therapeutic response to a maximum dose of 40mg by week 12. The trial was 16 weeks. The treatment trial has completed and is no longer accepting patients.
16317552|NCT00517751|Device|X-STOP PEEK|Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.
16317553|NCT00517738|Other|Physical training|A program of exercising under strict surveillance, with endurance and coordination maneuvers
16317554|NCT00517738|Other|Diet intervention|Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
16317555|NCT00517725|Drug|carvedilol|
16317556|NCT00517725|Drug|bisoprolol|
16317557|NCT00517725|Drug|Nebivolol|
16317558|NCT00517712|Drug|Single agent arsenic trioxide|duration of maintenance therapy, 6 months versus 12 months
16317559|NCT00517699|Drug|rituximab [MabThera/Rituxan]|750mg/m2 iv
16317560|NCT00517699|Drug|Methotrexate|8g/m2 iv
16317561|NCT00517699|Drug|Cytarabine|2g/m2 iv
16317562|NCT00517686|Other|Information feedback intervention|This study will evaluate an information feedback intervention: measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD).
16317563|NCT00517673|Drug|GSK945237|
16317564|NCT00517673|Drug|Sugar Pill|Placebo
16317565|NCT00517647|Drug|ATMX|Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
16317566|NCT00517634|Drug|FP|Fluticasone Propionate 100 mcg BD
16317567|NCT00517634|Drug|SFC|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD
16317568|NCT00517634|Drug|Placebo|Matching Placebo
16317569|NCT00517621|Drug|Paclitaxel|
16317570|NCT00517621|Drug|EPO|
16317571|NCT00517608|Device|Laparoscopic colectomy|
16317572|NCT00517595|Drug|Pemetrexed and Gemcitabine plus Bevacizumab|Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m^2 and gemcitabine 1500 mg/m^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
16317573|NCT00517582|Drug|HOE-140|Subcutaneous at time 0 and 6 hours
16317574|NCT00517582|Other|Placebo|Subcutaneous at time 0 and 6 hours
16317575|NCT00517569|Genetic|GX-12|a mixed plasma DNA (HIV-1 antigen genes and human IL-12 mutant) 4, 8, 16mg, i.m., once every other weeks for 22 weeks (total 12 times)
16317576|NCT00517569|Drug|HAART|Highly active antiretroviral therapy; Discontinuation at 24 weeks; NB: The patients should be treated with 2 NRTIs+1 NNRTI or 2 NRTIs + 1 PI, according to the guidelines published by DHHS in the USA.
16317577|NCT00517556|Drug|CCOCP|(CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol
16317578|NCT00517556|Drug|Traditional OCP|(traditional OCP) (21 active days/7 inactive days) treatment regimen
16317579|NCT00517543|Drug|GW856553|
16317580|NCT00517530|Drug|Obinutuzumab|Obinutuzumab was provided in single-dose glass vials as a freeze-dried powder.
16317581|NCT00517517|Biological|Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation|Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
16317582|NCT00517504|Drug|Methylphenidate|"1-week single blind placebo lead-in phase.
~step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week.
~Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects.
~After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control."
16317583|NCT00517491|Drug|lanreotide (Autogel formulation)|120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.
16317584|NCT00517478|Procedure|Blood Sample|
16317585|NCT00517465|Drug|Placebo|po bid
16317586|NCT00517465|Drug|RG1511|Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
16317587|NCT00517439|Drug|Copegus|1000/1200mg po daily for 24 weeks
16317588|NCT00517439|Drug|Pegasys|180 micrograms sc weekly for 24 weeks
16317589|NCT00517439|Drug|Pegasys|90 micrograms sc weekly for 24 weeks
16317590|NCT00517439|Drug|RO4588161|1000mg po bid for 24 weeks
16317591|NCT00517439|Drug|RO4588161|500mg po bid for 24 weeks
16317592|NCT00517439|Drug|RO4588161|1500mg po bid for 24 weeks
16317593|NCT00517426|Drug|acetazolamide|i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days
16317594|NCT00517413|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms sc or iv monthly, starting dose
16317595|NCT00517400|Device|Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham|
16317596|NCT00517387|Drug|Quetiapine XR|All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.
16317597|NCT00517361|Drug|carboplatin|AUC 6 in 250mL saline IV over 30 minutes
16317598|NCT00517361|Drug|bevacizumab|15mg/kg in 100mL saline IV over 60 - 90 minutes
16317599|NCT00517348|Biological|IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
16317600|NCT00517335|Procedure|Functional magnetic resonance imaging (fMRI) scan|Healthy control women, recovered bulimia women, and also recovered anorexia women will complete specific tasks in an fMRI scanner that will take up to 60 minutes.
16317601|NCT00517322|Drug|ramipril|ramipril 2.5- 5 mg once daily
16317602|NCT00517322|Drug|irbesartan|irbesartan 150-300 mg once daily
16317603|NCT00517309|Biological|V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years|
16317604|NCT00517309|Biological|Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years|
16317605|NCT00517296|Procedure|EUA with seton placement if necessary|Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
16317606|NCT00517296|Drug|adalimumab|Patients began therapy with adalimumab using clinic standards for dosing.
16317607|NCT00517296|Procedure|EUS|Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.
16317608|NCT00517283|Drug|exenatide and placebo|Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
16317609|NCT00517283|Drug|Exenatide and placebo|Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
16317610|NCT00517283|Drug|Exenatide and placebo|Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
16317611|NCT00517270|Drug|Rabeprazole 20mg twice daily|
16317612|NCT00517257|Drug|Atorvastatin|80 mg orally once daily for 24 weeks
16317613|NCT00517257|Drug|Placebo|Placebo tablet orally once daily for 24 weeks
16317614|NCT00517218|Drug|Genasense® (, oblimersen sodium G3139)|
16317615|NCT00517205|Procedure|Non-contrast helical computerized tomogram (NCHCT)|
16317616|NCT00517192|Drug|Tipranavir|
16317617|NCT00517192|Drug|Darunavir|
16317618|NCT00517192|Drug|Ritonavir|
16317619|NCT00517179|Drug|Vardenafil 10mg|
16317620|NCT00517166|Device|CAT (Combat Arms Tourniquet)|device
16317621|NCT00517153|Drug|miglustat|Patients aged 12 years or more randomised to the treatment group will receive 200 mg OGT 918 three times daily initially for twelve months. An additional sub-study of up to 12 patients aged under 12 years will receive a lower dose of OGT 918 according to their BSA
16317622|NCT00517140|Procedure|Repeat Caesaen section|
16317623|NCT00517140|Procedure|vaginal delivery|
16317624|NCT00517127|Drug|Lactated Ringer's Solution|Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
16317625|NCT00517127|Drug|Hydroxyethylstarch 6% 130/0.4|Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
16317626|NCT00517114|Drug|Rabeprazole 20mg twice daily|
16317627|NCT00517088|Drug|IPAQ|
16317628|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
16317629|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
16317630|NCT00517075|Device|Transcranial Magnetic Stimulation (TMS)|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
16317739|NCT00516321|Drug|placebo|matched placebo taken once daily orally
16317740|NCT00516308|Device|NightHawk|
16317631|NCT00517075|Device|repetitive transcranial magnetic stimulation|For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
16317632|NCT00517062|Drug|Growth hormone (Genotropin)|Growth hormone 0.1 mg self-injected once a day subcutaneously at bedtime.
16317633|NCT00517062|Drug|Placebo|Placebo self-injected once a day subcutaneously at bedtime.
16317634|NCT00517049|Drug|PRO95780|Intravenous repeating dose
16317635|NCT00517049|Drug|rituximab|Intravenous repeating dose
16317636|NCT00517036|Dietary Supplement|EPA omega-3 fatty acid|1 gram per day of an EPA-enriched mixture for 8 weeks
16317637|NCT00517036|Dietary Supplement|DHA omega-3 fatty acid|1 gram per day of pure DHA for 8 weeks
16317638|NCT00517036|Dietary Supplement|Placebo comparator|1 gram per day of an inactive substance for 8 weeks
16317639|NCT00517023|Device|Sleuth Implantable Loop Recorder|ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
16317640|NCT00517023|Other|Other|Routine care and tests usually offered for syncope patients.
16317641|NCT00517010|Drug|Proton beam irradiation and ranibizumab|ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
16317642|NCT00516984|Procedure|Placebo|No-touch control condition applied while subject was at a 50-degree head-up tilt.
16317643|NCT00516984|Procedure|Sham|Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
16317644|NCT00516984|Procedure|OMT|Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
16317645|NCT00516971|Drug|Esomeprazole 20mg once daily|
16317646|NCT00516958|Drug|Topical Dermacyn|Topical Dermacyn once a day for 10 Days
16317647|NCT00516958|Drug|Topical Dermacyn and Levofloxacin|Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
16317648|NCT00516958|Drug|Topical Saline and Levofloxacin|Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
16317649|NCT00516945|Drug|Lamivudine|
16317650|NCT00516919|Drug|Xenical + behavioral intervention|120 mg TID; Behavioral weight loss in Spanish
16317651|NCT00516919|Behavioral|Behavioral intervention + placebo|Behavioral weight loss treatment in Spanish Placebo TID
16317652|NCT00516906|Drug|Chlorhexidine gluconate|2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
16317653|NCT00516906|Drug|Transparent Adhesive Dressing|Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
16317654|NCT00516893|Biological|BG00002-E (natalizumab high titer)|
16317655|NCT00516880|Drug|rosiglitazone|
16317656|NCT00516867|Radiation|UV radiation|UV radiation with 99.5% UVA and 0.5%UVB
16317657|NCT00516867|Radiation|UV radiation|UVB 1.4 % and UVA 98.6
16317658|NCT00516854|Drug|chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily|
16317659|NCT00516841|Drug|Volociximab|15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops
16317660|NCT00516828|Drug|cytarabine|subcutaneously twice daily from Day 1 to 10
16317661|NCT00516802|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16317662|NCT00516802|Drug|dacarbazine|intravenous injection over at least 20 minutes
16317663|NCT00516750|Drug|cisplatin|
16317664|NCT00516750|Drug|doxorubicin hydrochloride|
16317665|NCT00516750|Drug|methotrexate|
16317666|NCT00516750|Drug|vinblastine|
16317667|NCT00516750|Genetic|gene expression profiling|
16317668|NCT00516750|Procedure|neoadjuvant therapy|
16317669|NCT00516737|Drug|Comparator: rizatriptan benzoate|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
16317670|NCT00516737|Drug|Comparator: Placebo|Matching placebo; one dose, treatment of a single migraine attack
16317671|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16317672|NCT00516724|Drug|Carboplatin|intravenous injection
16317673|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|Oral
16317674|NCT00516724|Drug|Paclitaxel|Intravenous injection
16317675|NCT00516724|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|Oral
16317676|NCT00516724|Drug|Paclitaxel + Carboplatin|Intravenous injection
16317677|NCT00516711|Drug|Sevoflurane|
16317678|NCT00516698|Genetic|polymorphism analysis|
16317679|NCT00516698|Other|high performance liquid chromatography|
16317680|NCT00516698|Other|laboratory biomarker analysis|
16317681|NCT00516698|Procedure|radiomammography|
16317682|NCT00516685|Biological|Recombinant Human rEGF-P64K/Montanide Vaccine|
16317683|NCT00516672|Drug|pazopanib|Pazopanib oral tablet
16317684|NCT00516672|Drug|Lapatinib|Lapatinib oral tablet
16317685|NCT00516659|Biological|Heat-Labile Enterotoxin of Escherichia coli (LT)|Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
16317686|NCT00516659|Biological|Placebo|The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
16317687|NCT00516646|Drug|ALT-711|200 mg bid
16317688|NCT00516646|Drug|Placebo|bid
16317689|NCT00516633|Behavioral|Extra information and support|Four group discussions with parents in close connection to diagnosing the children
16317690|NCT00516620|Behavioral|No further instruction|Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
16317691|NCT00516620|Behavioral|Food Delivery|Participants receive Canada's Food Guide and Physical Activity guide, in addition to a a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
16317741|NCT00516295|Drug|topotecan hydrochloride|Given IV
16317742|NCT00516295|Drug|vincristine sulfate|Given IV
16317743|NCT00516295|Drug|cyclophosphamide|Given IV
16317692|NCT00516620|Behavioral|Fruits (F), vegetables (V), and whole grain (WG) counseling|Participants receive Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317693|NCT00516620|Behavioral|Counseling to reduce soft drink intake.|Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317694|NCT00516620|Behavioral|Food Delivery & F, V & WG counseling.|Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317695|NCT00516620|Behavioral|Food delivery & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317696|NCT00516620|Behavioral|F, V, WG & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counseling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317697|NCT00516620|Behavioral|Food delivery and F,V, WG & soft drink counseling|Participants receive Health Canada's Food Guide and Physical Activity guide, receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
16317698|NCT00516607|Drug|enzastaurin hydrochloride|
16317699|NCT00516607|Drug|temozolomide|
16317700|NCT00516607|Other|pharmacological study|
16317701|NCT00516594|Procedure|Diet with polyfructans and viscous fibers or soy protein|
16317702|NCT00516542|Drug|letrozole|A daily dose of 2.5 mg will be used throughout the study.
16317703|NCT00516542|Drug|DHEA|Will be dispensed in either 500mg or 1000mg tablets. Subjects will start at a dose of 500 mg and may increase up to 5000mg depending on the cohort.
16317704|NCT00516542|Other|pharmacological study|PK draws will happen on day 1 and day 14, then every 2 weeks.
16317705|NCT00516516|Dietary Supplement|L-Carnitine|L-Carnitine, 1g orally, twice daily
16317706|NCT00516516|Dietary Supplement|Placebo|Placebo, similar in appearance to study tablets, given orally, twice daily.
16317707|NCT00516503|Drug|baclofen/amitriptyline/ketamine gel|Applied topically
16317708|NCT00516503|Other|placebo|Applied topically
16317709|NCT00516490|Drug|triptorelin acetate|Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
16317710|NCT00516490|Drug|Na Cl %0.9|0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer
16317711|NCT00516477|Biological|voretigene neparvovec-rzyl|Subjects will be dosed unilaterally (one eye) beginning with the lowest dose. Subjects will be injected with AAV2-hRPE65v2 by means of a subretinal injection. Dose escalation to the next cohort will be dependent on assessment of the safety data by the DSMB out to at least 4 weeks following the injection. Because there is a delay between time of delivery of AAV2 and the peak transgene expression there will be a delay of six weeks between all subjects.
16317712|NCT00516464|Drug|Lucentis (ranibizumab)|
16317713|NCT00516451|Drug|BMS-690514|Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more
16317714|NCT00516438|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16317715|NCT00516438|Drug|Topotecan|intravenous infusion
16317716|NCT00516425|Biological|pegfilgrastim|
16317717|NCT00516425|Drug|cyclophosphamide|
16317718|NCT00516425|Drug|doxorubicin hydrochloride|
16317719|NCT00516425|Drug|epirubicin hydrochloride|
16317720|NCT00516425|Genetic|proteomic profiling|
16317721|NCT00516425|Other|diagnostic laboratory biomarker analysis|
16317722|NCT00516425|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16317723|NCT00516425|Other|pharmacological study|
16317724|NCT00516425|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
16317725|NCT00516425|Procedure|adjuvant therapy|
16317726|NCT00516412|Drug|everolimus|Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16317727|NCT00516412|Genetic|molecular response by PCR|Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue
16317728|NCT00516399|Drug|povidone-iodine 1.25% ophthalmic solution|
16317729|NCT00516399|Drug|natamycin ophthalmic suspension, USP 5%|
16317730|NCT00516386|Drug|RhIGF-1|35-40 mcg/k/dose twice daily SC
16317731|NCT00516373|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16317732|NCT00516360|Device|3.15% chlorhexidine as daily antiseptic on needleless access port|3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed
16317733|NCT00516347|Genetic|comparative genomic hybridization|
16317734|NCT00516347|Genetic|genetic linkage analysis|
16317735|NCT00516347|Other|laboratory biomarker analysis|
16317736|NCT00516347|Other|questionnaire administration|
16317737|NCT00516347|Procedure|study of high risk factors|
16317738|NCT00516321|Drug|eltrombopag|25, 50, 75, 100 mg tablets taken once daily orally
16317745|NCT00516282|Drug|CLORETAZINE|CLORETAZINE will be administered intravenously on day 7. The starting dose of CLORETAZINE will be 100 mg/m2 given within 3 hours after the last dose of Temodar on day 7. CLORETAZINE will be given as an IV infusion over 15-30 minutes via a freely flowing peripheral or central intravenous line. CLORETAZINE will be escalated by 50 mg/m2 for the second cohort then by 25 mg/m2 increments in the following cohorts of 3-6 patients using a standard phase I trial design until a MTD is determined. If dose level 2 has two DLTs then patients will be accrued to a new dose level of 125 mg/m2. Prior to receiving Cloretazine, blood will be drawn for gene methylation studies.
16317746|NCT00516282|Drug|temozolomide|Temozolomide will be given orally at a dose of 75mg/m2 daily on day 1 through 7. There will be no dose modification for this agent. Prior to receiving Temozolomide, blood will be drawn for gene methylation studies.
16317747|NCT00516269|Drug|Methylphenidate|18 mg by mouth daily for 2 weeks
16317748|NCT00516269|Drug|Placebo|Capsule by mouth daily for 2 weeks
16317749|NCT00516256|Behavioral|CHESS System|Internet-based computer program for 6 months.
16317750|NCT00516256|Behavioral|Cancer Information Mentor|Phone calls to the patient for 6 months.
16317751|NCT00516243|Other|placebo|Given PO
16317752|NCT00516243|Other|quality-of-life assessment|Ancillary studies
16317753|NCT00516243|Procedure|questionnaire administration|Ancillary studies
16317754|NCT00516243|Procedure|laboratory biomarker analysis|Correlative studies
16317755|NCT00516243|Drug|defined green tea catechin extract|Given PO
16317756|NCT00516217|Biological|galiximab|
16317757|NCT00516191|Drug|Liposomal Doxorubicin/Melphalan/Bortezomib|"Day 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV
~The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2)"
16317758|NCT00516178|Drug|Fish oil emulsion|0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA
16317759|NCT00516178|Drug|Saline|3 infusions, perioperative or post-PTCA
16317760|NCT00516165|Drug|RAD001|Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days
16317761|NCT00516152|Drug|Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF|"Day Preparative Regimen for GVHD Prophylaxis
~7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
~3 Fludarabine 30 mg/m(2)IV
~2 REST Tacrolimus 0.01 mg/kg CIVI
~1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
~1 Methotrexate 5mg/m(2)IV
~3 Methotrexate 5mg/m(2)IV
~6 Methotrexate 5mg/m(2)IV
~7 G-CSF 5mcg/kg SQ daily
~11 Methotrexate 5mg/m(2)IV
~90 Evaluate Response"
16317762|NCT00516139|Drug|Lamotrigine|Open-label
16317763|NCT00516113|Drug|paroxetine|Capsules containing either placebo or paroxetine 20 mg. The treatment start after ovulation and when the subject has experienced premenstrual irritability for 2 days. The dosage is one capsule daily at 8 AM
16317764|NCT00516100|Drug|bortezomib|MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.
16317765|NCT00516087|Biological|Genetically modified CTLs|"LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~Three different dosing schedules will be evaluated. Each patient will receive two injections, 14 days apart, according to the following dosing schedules:
~Group One Day 0 2x10^7 cells/m2 Day 14 2x10^7 cells/m2
~Group Two Day 0 2x10^7 cells/m2 Day 14 1x10^8 cells/m2
~Group Three Day 0 1x10^8 cells/m2 Day 14 2x10^8 cells/m2"
16317766|NCT00516074|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16317767|NCT00516074|Drug|placebo|subcutaneous injection, volume equivalent to active, twice a day
16317768|NCT00516048|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16317769|NCT00516035|Biological|Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)|Vaccine given by nasal spray
16317770|NCT00516022|Drug|Mistletoe extract|The drug will be administered 3 times a week at home.
16317771|NCT00516009|Drug|DEXAMETHASONE|
16317772|NCT00516009|Other|PLACEBO|
16317773|NCT00515983|Biological|DC/Apo-Nec|
16317774|NCT00515970|Procedure|Curettage|"Curettage without subcutaneous tissue using a 7 mm ring curette and the fountain-pen technique (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm."
16317775|NCT00515970|Procedure|Deep excision|12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.
16317776|NCT00515970|Procedure|Shave excision|Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.
16317828|NCT00515476|Behavioral|physical exercise|8 weeks of regular exercise training
16317829|NCT00515463|Biological|denosumab|60 mg denosumab in 1mL
16317830|NCT00515463|Biological|denosumab|60 mg denosumab in 1mL
16317831|NCT00515450|Biological|GB-0998 (Intravenous immunoglobulin)|
16317832|NCT00515450|Procedure|Plasmapheresis|
16317833|NCT00515437|Biological|Botulinum Toxin Type B (Myobloc)|
16317834|NCT00515437|Biological|Matched placebo to Myobloc|
16317835|NCT00515424|Drug|RKI983|
16317777|NCT00515970|Procedure|Curettage|"Curettage with a 7 mm ring curette with the potato-peeler technique (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining."
16317778|NCT00515957|Genetic|genetically modified CTLs in combo with CD45 antibodies|"LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb).
~--Infusions of CD45 MAbs: A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used43, 400ug/kg over 6 to 8 hrs daily x 4 given as 4 daily intravenous infusions that will be completed 48-72 hours prior to CTL infusion.
~Day 1 YTH 24/54 400ug/kg over 6 to 8 hr 2 YTH 24/54 400ug/kg over 6 to 8 hr 3 YTH 24/54 400ug/kg over 6 to 8 hr 4 YTH 24/54 400ug/kg over 6 to 8 hr 5 Rest 6-8 CTL Infusion (provided CD45 MAb level <100 ng/ml)
~--LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~2x 10^7 cells/m2
~1x 10^8 cells/m2 3 x 10^8 cells/m2
~1 x 10^9 cells/m2"
16317779|NCT00515944|Drug|Botulinum neurotoxin type A, free of complexing proteins|
16317780|NCT00515931|Radiation|Radiation therapy (external beam photons)|A cumulative radiation dose of 30 to 40 Gy is administered in 1.8 to 2.0 Gy fractions, 5 fractions per week, to the target lesion(s).
16317781|NCT00515918|Dietary Supplement|iron|
16317782|NCT00515905|Drug|Sevoflurane/propofol|Sevoflurane/propofol
16317783|NCT00515892|Drug|Immunotoxin therapy|
16317784|NCT00515892|Drug|CAT-8015 Immunotoxin|
16317785|NCT00515892|Procedure|Biological therapy|
16317786|NCT00515892|Procedure|Antibody Therapy|
16317787|NCT00515892|Procedure|Monoclonal Antibody Therapy|
16317788|NCT00515879|Drug|D-cycloserine|50 mg
16317789|NCT00515879|Behavioral|Cognitive behavioral therapy (CBT)|CBT sessions aim to help participants become more comfortable with social situations.
16317790|NCT00515879|Drug|Placebo|Same dosage as active pill
16317791|NCT00515866|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16317792|NCT00515866|Drug|Gemcitabine|intravenous injection
16317793|NCT00515853|Behavioral|Biofeedback|Biofeedback sessions or biofeedback exercises
16317794|NCT00515840|Other|Physiotherapist|Physiotherapist administered breathing retraining programme
16317795|NCT00515827|Drug|Raltegravir (MK-0518)|400 mg tablet taken orally twice daily
16317796|NCT00515827|Drug|Placebo|400 mg placebo tablet taken orally twice daily
16317797|NCT00515814|Device|Retina implant is surgically placed into subretinal position|Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.
16317798|NCT00515801|Drug|glibenclamide|glibenclamide 15 mg single dose
16317799|NCT00515801|Drug|placebo|placebo capsules, single dose
16317800|NCT00515788|Drug|DepoCyt|Starting dose of 50 mg Intrathecal on Day 1 every 14 days for a total of 12 weeks (6 treatments). After the first 12 weeks, 50 mg Intrathecal on Day 1 every 28 days for 40 weeks (10 treatments).
16317801|NCT00515788|Drug|Temozolomide|100 mg/m^2 (capsules) by mouth daily for 7 consecutive days every 14 days.
16317802|NCT00515762|Device|elasto-gel cap|scalp cooling cap
16317803|NCT00515736|Drug|Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E|Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
16317804|NCT00515736|Drug|Placebo|vehicle
16317805|NCT00515723|Drug|risperidone|randomized to 12 week trial of risperidone.
16317806|NCT00515723|Drug|olanzapine|randomized to 12 week trial of olanzapine.
16317807|NCT00515723|Drug|quetiapine|randomized to 12 week trial of quetiapine.
16317808|NCT00515723|Drug|ziprasidone|randomized to 12 week trial of ziprasidone.
16317809|NCT00515697|Biological|Ramucirumab|Ramucirumab is an injectable solution administered as an intravenous infusion over 1 hour at a dose of 8 mg/kg day 1 of every 14-day cycle.
16317810|NCT00515684|Drug|bevacizumab (Avastin)|
16317811|NCT00515671|Behavioral|Illness Management and Recovery|a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
16317812|NCT00515671|Behavioral|Problem Solving|Weekly problem-solving support group
16317813|NCT00515658|Device|theta-burst rTMS|
16317814|NCT00515645|Other|Head-down tilt and immersion|Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two
16317815|NCT00515632|Drug|Balaglitazone|One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
16317816|NCT00515619|Drug|Lacosamide|50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
16317817|NCT00515606|Drug|helium:oxygen|
16317818|NCT00515593|Drug|Parathyroid hormone (PTH) (Preotact)|Patients with severe postmenopausal osteoporosis
16317819|NCT00515580|Procedure|Tongue Sutures for Obstructive Sleep Apnea|Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.
16317820|NCT00515554|Drug|Rituximab|addition of Rituximab to BEACOPP escalated
16317821|NCT00515554|Drug|BEACOPP escalated|chemotherapy with BEACOPP escalated
16317822|NCT00515541|Drug|Lovaza|First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
16317823|NCT00515528|Biological|4-peptide melanoma vaccine|Experimental cancer vaccine given as a shot under the skin once every two weeks
16317824|NCT00515528|Drug|Ontak|A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.
16317825|NCT00515502|Drug|GSK573719|250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg
16317826|NCT00515502|Drug|Tiotropium|strips of five capsules, each containing 18 μg administered via dry powder inhaler
16317836|NCT00515411|Drug|Docetaxel, Leucovorin, Fluorouracil, Cisplatin|Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
16317837|NCT00515411|Drug|Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen|"Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg* subcut x 7 d 10-17
~* 300 mcg for weight < 60 kg, 480 mcg for weight > 60 kg
~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
16317838|NCT00515411|Drug|Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab|"Treatment for Her2 Positive Participants
~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
16317839|NCT00515398|Other|Observation|Ex vivo administration of AT2220
16317840|NCT00515385|Drug|MGAWN1|"Eight subjects per cohort, each receives a single IV infusion of MGAWN1 of saline control on study day 0 (6 MGAWN1, 2 saline control.
~Cohort 1 - 0.3 mg/kg Cohort 2 - 1 mg/kg Cohort 3 - 3 mg/kg Cohort 4 - 10 mg/kg Cohort 5 - 30 mg/kg"
16317841|NCT00515385|Drug|MGAWN1|Single IV dose
16317842|NCT00515385|Other|Placebo|Single IV dose
16317843|NCT00515372|Other|Telephone Counseling|Weekly phone calls lasting about 30 minutes.
16317844|NCT00515372|Other|Usual Care|Lists of professional resources and referral recommendations will be provided.
16317845|NCT00515359|Procedure|Intermittent Propofol Sedation|Intermittent versus continuous dosage
16317846|NCT00515359|Procedure|Continuous Propofol Sedation|intermittent vs continuous dosage
16317847|NCT00515346|Device|Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia|
16317848|NCT00515333|Drug|TRx0014|Hard capsule; 60 milligrams; t.i.d.
16317849|NCT00515333|Drug|TRx0014|Hard capsule; 30 milligrams; t.i.d.
16317850|NCT00515333|Drug|Placebo|Hard capsule; 0 milligrams; t.i.d.
16317851|NCT00515333|Drug|TRx0014|Hard capsule, 100 milligrams, t.i.d.
16317852|NCT00515320|Drug|Fluoxetine|Once daily oral dispersible tablet 2mg 9mg or 18mg
16317853|NCT00515320|Drug|Placebo|Oral dispersible tablet placebo
16317854|NCT00515307|Procedure|Cellular transplantation|600 million to 1 billion cells will be infused through the portal vein over 30 minutes. Infusion will be done one time.
16317855|NCT00515294|Drug|Caffeinated Alcoholic Beer|Alcoholic Beer plus Caffeine Citrate powder.
16317856|NCT00515294|Other|Non-Caffeinated Alcoholic Beer|Alcoholic Non-Caffeinated Beer
16317857|NCT00515294|Drug|Caffeinated Non-Alcoholic Beer|Non-Alcoholic Beer plus Caffeine Citrate powder.
16317858|NCT00515294|Other|Non-Caffeinated, Non-Alcoholic Beer|Non-Alcoholic Beer
16317859|NCT00515281|Drug|inhaled nitric oxide|The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.
16317860|NCT00515281|Drug|oxygen|The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation.
16317861|NCT00515268|Drug|GSK256066|GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
16317862|NCT00515268|Drug|Placebo|Subjects will receive placebo inhaler.
16317863|NCT00515255|Drug|Minocycline|Capsules
16317864|NCT00515242|Behavioral|massage|therapeutic massage
16317865|NCT00515242|Behavioral|thermotherapy|heat therapy
16317866|NCT00515242|Behavioral|relaxing environment|time in a relaxing environment
16317867|NCT00515229|Drug|amitriptyline|"Each individual capsule has a filling volume of 25 mg, 50 mg und 75 mg Amitriptyline.
~Placebo: 25 mg corn starch"
16317868|NCT00515216|Drug|5-fluorouracil|
16317869|NCT00515216|Drug|Oxaliplatin|
16317870|NCT00515216|Drug|Leucovorin|
16317871|NCT00515203|Drug|Placebo|Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
16317872|NCT00515203|Drug|AMG 531|Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
16317873|NCT00515190|Drug|S-1,oxaliplatin|"Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.
~Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles."
16317874|NCT00515177|Behavioral|Mindfulness-Based Stress Reduction|The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
16317875|NCT00515177|Drug|eszopiclone|"One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
16317876|NCT00515164|Drug|Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel|20 mL Hydrogel
16317877|NCT00515151|Drug|0.1% Octenidine with 30% 1-propanol and 45% 2-propanol|Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
16317878|NCT00515151|Drug|74% Ethanol with 10% 2-propanol|Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
16317918|NCT00514904|Biological|Mencevax|Single dose, subcutaneous injection
16317879|NCT00515138|Drug|Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib|Bortezomib starting at 1 mg/m(2), and escalating to 1.3, 1.5, 1.7. Bortezomib will be given on Days 1 (prior to rituximab) and 4, rituximab at 375 mg/m(2) on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 mg/m(2), on day 3 and etoposide 100 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6
16317880|NCT00515125|Behavioral|Dietary Advice|Dietary Advice sheet
16317881|NCT00515125|Dietary Supplement|Oral Nutritional Supplements (Fortisip)|"These products are classified as non-medicinal, borderline substances, foods for special medical purposes.
~A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 12 week period."
16317882|NCT00515112|Drug|AndroGel|Androgel 1%, 10g daily
16317883|NCT00515112|Drug|placebo|placebo
16317884|NCT00515099|Drug|Antithymocyte globulin|Daily 4-day escalating dose
16317885|NCT00515099|Drug|Placebo|Daily 4-day saline solution
16317886|NCT00515086|Drug|Everolimus|Tablets taken once a day with a full glass of water.
16317887|NCT00515086|Procedure|Surgery|Salvage surgical resection
16317888|NCT00515073|Drug|Paclitaxel|50 mg/m^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.
16317889|NCT00515073|Radiation|Pelvic Radiation|Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.
16317890|NCT00515073|Drug|Dexamethasone|20 mg IV given 30 minutes prior to chemotherapy
16317891|NCT00515073|Drug|Cimetidine|300 mg IV given 30 minutes prior to chemotherapy
16317892|NCT00515073|Drug|Diphenhydramine|50 mg IV given 30 minutes prior to chemotherapy
16317893|NCT00515060|Other|Sensory Tests|Tests to find the threshold at which perceive stimuli.
16317894|NCT00515034|Drug|Imipenem/cilastatin|Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
16317895|NCT00515034|Drug|Imipenem/cilastatin|Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
16317896|NCT00515034|Drug|Doripenem|1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
16317897|NCT00515034|Drug|Doripenem|1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
16317898|NCT00515021|Drug|Eplerenone (Morning)|"Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg.
~100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks."
16317899|NCT00515021|Drug|Eplerenone (Night-time)|Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg
16317900|NCT00515008|Behavioral|Tai Chi Intervention|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
16317901|NCT00515008|Behavioral|Control Intervention|Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
16317902|NCT00514995|Drug|Sodium Oxybate|4.5 g/night - 9 g/night, liquid taken twice per night
16317903|NCT00514982|Drug|Mesalamine|5-Aminosalicylic Acid Derivative used to treat mild to moderate Ulcerative Colitis
16317904|NCT00514982|Drug|Infliximab|Antirheumatic, Disease Modifying Gastrointestinal Agent, Miscellaneous, Monoclonal Antibody, Tumor Necrosis Factor (TNF) Blocking Agent used to treat gastrointestinal disorders.
16317905|NCT00514982|Drug|Corticosteroids|Systemic Corticosteroid used to treat inflammatory conditions.
16317906|NCT00514982|Drug|6-Mercaptopurine|Antineoplastic Agent, Antimetabolite, Immunosuppressant Agent used traditionally to treat Acute lymphoblastic leukemia. Unlabeled use as steroid-sparing agent for corticosteroid-dependent Crohn's disease (CD) and ulcerative colitis (UC); maintenance of remission in CD; fistulizing Crohn's disease.
16317907|NCT00514982|Drug|Tacrolimus|Immunosuppressant Agent used to treat Liver, Heart, Kidney transplant, prevent host vs graft disease, severe atopic dermatitis.
16317908|NCT00514982|Drug|Adalimumab|Antirheumatic, Monoclonal Antibody, Tumor Necrosis Factor (TNF) Blocking Agent used to treat Rheumatoid arthritis and Crohn's disease.
16317909|NCT00514969|Drug|Imatinib (STI571)|
16317910|NCT00514956|Behavioral|Emotional Freedom Techniques (EFT)|
16317911|NCT00514943|Drug|BIBW 2992|experimental drug taken once daily orally
16317912|NCT00514943|Drug|Cetuximab|active comparator administered weekly intravenously
16317913|NCT00514930|Device|Hexablate|
16317914|NCT00514917|Drug|Docetaxel|75 mg/m^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
16317915|NCT00514917|Drug|Leuprolide|22.5 mg injection subcutaneously every 12 weeks up to 18 months.
16317916|NCT00514917|Drug|Bicalutamide|50 mg tablet orally once daily for first 4 weeks of treatment.
16317917|NCT00514904|Biological|Nimenrix|Single dose, intramuscular injection
16317919|NCT00514891|Biological|Vitamin A|The effect of vitamin A given with different vaccines will be studied
16317920|NCT00514865|Drug|ONO-2333Ms|5-10 mg QD for 8 weeks
16317921|NCT00514865|Drug|ONO-2333Ms|0 mg QD for 8 weeks
16317922|NCT00514865|Drug|ONO-2333Ms|1-2 mg QD for 8 weeks
16317923|NCT00514852|Drug|Carboxymethylcellulose and Glycerin based artificial tear|1 to 2 drops into each eye as needed but at least twice daily
16317924|NCT00514852|Drug|Carboxymethylcellulose|1 to 2 drops into each eye as needed but at least twice daily
16317925|NCT00514839|Behavioral|Motivational Interviewing|Two sessions of Motivational Interviewing (after baseline assessment and 4 weeks later) plus one individualized feedback based on the Transtheoretical Model of Behavior Change (8 weeks after baseline assessment)
16317926|NCT00514826|Other|altitude exposure|sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each
16317927|NCT00514813|Drug|Dynepo|Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
16317928|NCT00514800|Behavioral|Intervention - a validated home BP monitor and support from the specialist nurse|
16317929|NCT00514800|Behavioral|Control - usual care (BP monitoring by their practice)|"Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management.
~GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings."
16317930|NCT00514774|Drug|ursodiol|"ursodiol 300 mg twice daily for study days 0 through 28
~ursodiol 600mg twice daily on study days 0 through 28"
16317931|NCT00514774|Drug|placebo|placebo 600mg twice daily for study days 0 through 28
16317932|NCT00514761|Drug|AZD6244|oral vial
16317933|NCT00514761|Drug|Capecitabine|oral tablet
16317934|NCT00514748|Procedure|DIEP|flap survival, operation time, flap complications, donor site morbidity.
16317935|NCT00514748|Procedure|Interconnected DIEP|flap survival, operation time, flap complications, donor site morbidity.
16317936|NCT00514735|Procedure|Medtronic Cardiac Ablation System|Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.
16317937|NCT00514735|Drug|Class I or III Antiarrhythmic Medications|Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.
16317938|NCT00514722|Other|umbilical cord stem cells|umbilical cord stem cell allogeneic transplantation
16317939|NCT00514709|Biological|DTaP-HB PRP~T Combined Vaccine|0.5 mL, Intramuscular (IM)
16317940|NCT00514709|Biological|DTaP-HB-PRP~T vaccine|0.5 mL, IM
16317941|NCT00514709|Biological|Oral Polio Vaccine|Oral co-administered with study vaccine.
16317942|NCT00514696|Drug|GCS-100|GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle
16317943|NCT00514683|Drug|low dose BIBF1120 once daily|low dose BIBF1120 once daily
16317944|NCT00514683|Drug|low dose BIBF 1120 twice daily|low dose BIBF 1120 twice daily
16317945|NCT00514683|Drug|intermediate dose BIBF 1120 twice daily|intermediate dose BIBF 1120 twice daily
16317946|NCT00514683|Drug|high dose BIBF 1120 twice daily|high dose BIBF 1120 twice daily
16317947|NCT00514683|Drug|placebo|placebo
16317948|NCT00514670|Other|Alcohol-based hand sanitizer & quaternary ammonium wipes|
16317949|NCT00514657|Drug|Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)|
16317950|NCT00514644|Other|Carotid ultrasound examination|Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
16317951|NCT00514644|Other|Panorama examination|"Examination with the odontological radiological method Panorama, including a frontal verification image"
16317952|NCT00514618|Drug|Misoprostol|patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4)
16317953|NCT00514618|Dietary Supplement|Placebo|patients will receive placebo (vitamin C) q day for two days (days 1 and 4)
16317954|NCT00514605|Other|Behavioral counseling|Standard-of-Care counseling at the Point-of-Care.
16317955|NCT00514605|Device|HIV-1 Antibody Test Kit|Assay to detect HIV antibodies
16317956|NCT00514592|Other|New Guidelines|New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
16317957|NCT00514579|Procedure|Cord blood transplantation|Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
16317958|NCT00514566|Device|Suture for midline abdominal closure|closure with Polyamide or Polydioxanone
16317959|NCT00514540|Drug|Docetaxel|75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.
16317960|NCT00514540|Drug|Carboplatin|AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
16317961|NCT00514540|Drug|Etoposide|120 mg/m^2 daily for 3 days of 21 day cycle.
16317962|NCT00514540|Drug|Cisplatin|25 mg/m^2 for 3 days of 21 day cycle.
16317963|NCT00514527|Drug|oritavancin|Oritavancin as a single, infrequent or daily dose.
16317964|NCT00514514|Drug|Everolimus|Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen
16317965|NCT00514514|Drug|Myfortic|"1 tablet containing 180 mg or 360 mg
~Dosing schedule:
~Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day)"
16317966|NCT00514514|Drug|Sandimmun Optoral|1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level
16317967|NCT00514514|Drug|Simulect®|Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4
16317968|NCT00514501|Drug|Iodofiltic acid I 123|
16317969|NCT00514488|Drug|STI571 (400 mg/day; or 800 mg/day)|
16317970|NCT00514475|Drug|90Y-ibritumomab tiuxetan (Zevalin)|90Y-ibritumomab tiuxetan (Zevalin) at 0.4 mCi/kg is administered one week prior to start high-dose chemotherapy (BEAM/BEAC) in patients who have not achieved CR after induction therapy. Predosing with rituximab 250 mg/m2 one weeks prior to radioimmunotherapy and the same day.
16317971|NCT00514462|Device|diode laser|wavelength at 830nm, 9.7J/cm2 for 10 min
16317972|NCT00514449|Drug|Valacyclovir|1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic
16317973|NCT00514449|Drug|Placebo|2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic
16317974|NCT00514436|Behavioral|Asthma coaching|Inperson contact followed by telephone with approach by issues raised by family
16317975|NCT00514423|Other|Psychoeducation by professonals|
16317976|NCT00514423|Other|Psychoeducation by peer-moderators|
16317977|NCT00514423|Other|Video-education|
16317978|NCT00514423|Other|Noneducational video group (control group)|
16317979|NCT00514410|Drug|Folic Acid|Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment
16317980|NCT00514410|Drug|Placebo|Matching placebo taken once a day for three months
16317981|NCT00514397|Drug|motexafin gadolinium|
16317982|NCT00514397|Drug|temozolomide|
16317983|NCT00514397|Procedure|adjuvant therapy|
16317984|NCT00514397|Procedure|quality-of-life assessment|
16317985|NCT00514397|Radiation|radiation therapy|
16317986|NCT00514371|Drug|tanespimycin|High dose
16317987|NCT00514371|Drug|Bortezomib|Mid dose, and low dose
16317988|NCT00514345|Genetic|gene expression analysis|
16317989|NCT00514345|Genetic|polymorphism analysis|
16317990|NCT00514345|Procedure|management of therapy complications|
16317991|NCT00514332|Procedure|stent|stent placement for colorectal cancer obstruction
16317992|NCT00514306|Drug|OSI-906|Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
16317993|NCT00514293|Drug|bexarotene|
16317994|NCT00514293|Drug|capecitabine|
16317995|NCT00514293|Drug|carboplatin|
16317996|NCT00514293|Drug|cisplatin|
16317997|NCT00514293|Drug|docetaxel|
16317998|NCT00514293|Drug|tretinoin|
16317999|NCT00514267|Drug|YM 155|IV
16318000|NCT00514267|Drug|Docetaxel|IV
16318001|NCT00514267|Drug|Prednisone|Oral
16318002|NCT00514254|Other|questionnaire administration|
16318003|NCT00514254|Other|study of socioeconomic and demographic variables|
16318004|NCT00514254|Procedure|evaluation of cancer risk factors|
16318005|NCT00514241|Device|The GPS™ II Platelet Concentrate Separation Kit|The GPS™ II Platelet Concentrate Separation Kit system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
16318006|NCT00514228|Drug|sunitinib malate|"Starting dose: 37.5 mg 3 x 12.5 mg capsule
~Reduced dose: 25 mg 2 x 12.5 mg capsule"
16318007|NCT00514215|Biological|sargramostim|250 μg, inhaled, two times a day, on days 4-10 and days 36-42
16318008|NCT00514215|Other|flow cytometry|Days 1 & 32
16318009|NCT00514215|Other|immunoenzyme technique|Days 1 & 32
16318010|NCT00514215|Procedure|biopsy|CT guided biopsy on days 1 & 32
16318011|NCT00514215|Procedure|cryosurgery|Days 1 and 32
16318012|NCT00514202|Drug|Placebo|matched placebo
16318013|NCT00514202|Drug|Dextroamphetamine SR|60 mg/day
16318014|NCT00514189|Biological|Autologous Dendritic Cells|The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).
16318015|NCT00514163|Drug|gemcitabine + S-1|gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
16318016|NCT00514163|Drug|gemcitabine|gemcitabine DIV on day one , 8th and 15th
16318017|NCT00514150|Drug|Sodium Bicarbonate plus normal saline 0.9%|IV sodium bicarbonate 8.4% solved in 154 mEq/ L NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
16318018|NCT00514150|Drug|normal saline 0.9%|IV 154 mEq/L solution of NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.)
16318019|NCT00514137|Drug|sunitinib malate|Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
16318020|NCT00514111|Drug|pegylated-interferon, conventional-interferon, ribavirin|Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.
16318021|NCT00514085|Biological|recombinant human interleukin-21|"Patients enrolled in Part A will receive treatment daily x 5 on weeks 1, 3, and 5 of an 8 week cycle.
~Patients enrolled in Part B will receive treatment daily x 5 on weeks 1, and 3 of a 6 week cycle"
16318022|NCT00514085|Other|immunohistochemistry staining method|Cycle 1 Day 1 and Cycle 1 Day 29
16318023|NCT00514085|Other|laboratory biomarker analysis|slides will be blocked for 15 minutes in 20% normal goat serum and then incubated in primary antibody
16318024|NCT00514085|Other|pharmacological study|Starting dose of 50μg/kg/day as an IV push
16318025|NCT00514072|Biological|BCG vaccine|given intradermally
16318026|NCT00514072|Biological|prostate cancer vaccine ONY-P1|given intradermally
16318027|NCT00514072|Other|placebo|given intradermally
16318028|NCT00514059|Drug|Boostrix polio|1 dose (0.5 ml) i.m.
16318029|NCT00514046|Drug|Vandetanib|once daily continuously (28 day cycles)
16318030|NCT00514033|Biological|Poliomyelitis vaccine (inactivated) -PoliorixTM|Deep intramuscular injections for the primary vaccination and booster vaccination.
16318031|NCT00514020|Drug|fluorouracil|Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
16318032|NCT00514020|Drug|leucovorin calcium|through a vein over 2 hours on days 1 and 15.
16318033|NCT00514020|Drug|oxaliplatin|500 ml D5W through a vein over 2 hours on days 1 and 15.
16318034|NCT00514020|Genetic|gene expression analysis|Blood collection
16318035|NCT00514020|Genetic|polymorphism analysis|Blood collection
16318036|NCT00514020|Genetic|protein expression analysis|Blood collection
16318037|NCT00514020|Other|pharmacological study|Blood collection
16318039|NCT00513994|Drug|Nitroglycerin|MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
16318040|NCT00513981|Drug|leucovorin calcium|
16318041|NCT00513981|Drug|methotrexate|
16318042|NCT00513981|Other|mass spectrometry|
16318043|NCT00513981|Other|pharmacological study|
16318044|NCT00513968|Genetic|a mixed plasmid DNA (HB-110)|HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.
16318045|NCT00513968|Drug|Adefovir|Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
16318046|NCT00513955|Drug|bortezomib|
16318047|NCT00513955|Drug|cyclophosphamide|
16318048|NCT00513955|Drug|doxorubicin hydrochloride|
16318049|NCT00513955|Drug|prednisolone|
16318050|NCT00513955|Drug|vincristine sulfate|
16318051|NCT00513955|Other|questionnaire administration|
16318052|NCT00513955|Procedure|quality-of-life assessment|
16318053|NCT00513942|Other|Fetal Movement Counting|Women in the intervention group will receive an information pamphlet. The main items will be basic information and interpretation of fetal activity and instructions when to contact health professionals if experiencing DFM.
16318054|NCT00513929|Dietary Supplement|Zinc sulphate|Arm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment.
16318055|NCT00513916|Dietary Supplement|soy isoflavones|High or low dose of soy isoflavones in the diet.
16318056|NCT00513903|Behavioral|Minimal intervention|Minimal intervention patients will be seen by a clinical pharmacist during the hospitalization period to improve continuity of pharmacy care following hospital discharge.
16318057|NCT00513903|Behavioral|Enhanced Intervention|Enhanced intervention patients will be visited in the hospital and will also be called by the clinical pharmacist following discharge to follow-up on any problems that might have developed after discharge.
16318058|NCT00513890|Device|Infantflow [EME, Brighton, England]|
16318059|NCT00513877|Drug|bortezomib|
16318060|NCT00513877|Procedure|quality-of-life assessment|
16318061|NCT00513864|Drug|Dextromethorphan|one time dose - 0.3mg/kg PO
16318062|NCT00513864|Drug|Codeine|one time dose - 2mg/kg PO
16318063|NCT00513864|Drug|Morphine|one time dose - 0.15mg/kg IV
16318064|NCT00513851|Drug|OSI-930|Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
16318065|NCT00513851|Drug|OSI-930|Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
16318066|NCT00513825|Drug|Sodium Bicarbonate|IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
16318067|NCT00513799|Drug|Mupirocin ointment|Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
16318068|NCT00513799|Genetic|Chlorhexidine showers|Apply Clorhexidine wash to entire body once daily for 5 days.
16318069|NCT00513799|Procedure|Bleach baths (dilute)|Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
16318070|NCT00513799|Behavioral|Intensive education on personal hygiene|Repeat hygiene methods for 5 days.
16318071|NCT00513786|Drug|Carboplatin|AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
16318072|NCT00513786|Drug|Paclitaxel|175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
16318073|NCT00513786|Drug|bevacizumab|15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
16318074|NCT00513760|Dietary Supplement|Grapefruit juice|Coingestion of 240 ml of grapefruit juice with 10 mg of montelukast.
16318075|NCT00513760|Dietary Supplement|Orange Juice|Coingestion of 240 ml of orange juice with 10 mg of montelukast.
16318076|NCT00513760|Dietary Supplement|Gatorade|Coingestion of 240 ml of Gatorade with 10 mg of montelukast.
16318077|NCT00513747|Biological|rituximab|Given IV over 4 hours
16318078|NCT00513747|Drug|fludarabine phosphate|Given IV over 30 minutes
16318079|NCT00513734|Other|Hydrogel dressing|3x3cm hydrogel dressing over closed eye
16318080|NCT00513734|Other|Lacrilube ointment|lubricant put into eye (inferior formix)
16318081|NCT00513708|Behavioral|Motivation Enhancement Therapy (MET)|"Participants assigned to this arm will receive a 60-minute MET intervention in addition to usual care while hospitalized for detoxification."
16318082|NCT00513708|Behavioral|Peer-Twelve Step Facilitation (P-TSF)|"In addition to usual care while hospitalized for detoxification, participants assigned to this arm will receive a 60-minute visit by peers who are recovering from alcoholism and who are active in 12-step oriented self-help programs."
16318083|NCT00513695|Drug|sunitinib malate|Given PO
16318084|NCT00513695|Drug|paclitaxel|Given IV
16318085|NCT00513695|Drug|doxorubicin hydrochloride|Given IV
16318086|NCT00513695|Drug|cyclophosphamide|Given PO
16318087|NCT00513695|Biological|filgrastim|Given SC
16318088|NCT00513695|Procedure|therapeutic conventional surgery|Undergo surgery
16318089|NCT00513695|Other|laboratory biomarker analysis|Correlative studies
16318090|NCT00513695|Other|flow cytometry|Correlative studies
16318091|NCT00513682|Drug|Ultrase® MT20|Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be followed by a washout phase of 6 to 7 days, in which participants will receive only high-fat diet; then stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) will be administered orally for 7 to 11 days during treatment phase. The stabilized dose should not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
16318092|NCT00513669|Biological|PEV 301& 302 in virosomes|PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90
16318994|NCT00507091|Drug|ZD6474 (vandetanib) 300mg|once daily oral tablet
16318093|NCT00513669|Biological|Inflexal V (active comparator)|Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90
16318094|NCT00513656|Drug|Oxycodone|
16318095|NCT00513656|Drug|Oxycodone/Naloxone|
16318096|NCT00513643|Drug|insulin aspart|6, 12, 24 U s.c.
16318097|NCT00513643|Drug|human regular insulin|6, 12 and 24 IU sc
16318098|NCT00513630|Drug|Glipizide|
16318099|NCT00513630|Drug|Metformin|
16318100|NCT00513617|Drug|Arginine|Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.
16318101|NCT00513617|Drug|Placebo|Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.
16318102|NCT00513604|Biological|aldesleukin|Given subcutaneously every 8 hours for up to 15 doses, day 0, 720,000 IU/kg
16318103|NCT00513604|Biological|therapeutic autologous lymphocytes|Given as infusion, up to 3 x 10^11 lymphocytes (minimum of 1 x 10^9), day 0
16318104|NCT00513604|Drug|Cyclophosphamide|Given intravenously 60 mg/kg/day, day -7 to -6
16318105|NCT00513604|Drug|Fludarabine phosphate|Given intravenously 25 mg/m^2/day over 15-30 minutes, day -5 to -1
16318106|NCT00513604|Radiation|Total body irradiation|600 cGy
16318107|NCT00513578|Biological|PR1 leukemia peptide vaccine|
16318108|NCT00513578|Biological|incomplete Freund's adjuvant|
16318109|NCT00513578|Biological|sargramostim|
16318110|NCT00513565|Drug|single dose|Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
16318111|NCT00513552|Drug|Rifabutin, Clarithromycin, and Clofazimine|Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning
16318112|NCT00513539|Drug|porfimer sodium|
16318113|NCT00513539|Procedure|biliary stenting|
16318114|NCT00513526|Biological|Gardasil|week 0, 8, 24, 128
16318115|NCT00513513|Drug|TMC114 (darunavir) / ritonavir|
16318116|NCT00513500|Drug|Coartem and amoxicillin|Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
16318117|NCT00513500|Drug|Coartem|Give Coartem without RDT and refer fast breathing
16318118|NCT00513487|Drug|Dust mite extract, Fluticasone, Methacholine|Dust mite extract, Fluticasone, Methacholine
16318119|NCT00513474|Drug|busulfan|Busulfan 3.2 mg/kg/day from day -7 to day -4 as standard of care for myeloablative (bone marrow depletion) conditioning at the investigator's discretion
16318120|NCT00513474|Drug|cyclophosphamide|Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion
16318121|NCT00513474|Drug|cyclosporin-A|Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion
16318122|NCT00513474|Drug|etoposide|Etoposide as standard of care for myeloablative conditioning at the investigator's discretion
16318123|NCT00513474|Drug|methotrexate|Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion
16318124|NCT00513474|Drug|rasburicase|Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days
16318125|NCT00513474|Drug|sirolimus|Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion
16318126|NCT00513474|Drug|tacrolimus|Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion
16318127|NCT00513474|Procedure|allogeneic hematopoietic stem cell transplantation|
16318128|NCT00513474|Procedure|peripheral blood stem cell transplantation|
16318129|NCT00513474|Radiation|total-body irradiation|Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion
16318130|NCT00513474|Drug|fludarabine|Fludarabine 40 mg/m^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion
16318131|NCT00513474|Drug|allopurinol|Allopurinol per institutional guidelines
16318132|NCT00513461|Drug|S-adenosyl-L-methionine disulfate p-toluene-sulfonate|Given PO
16318133|NCT00513461|Other|placebo|Given PO
16318134|NCT00513461|Other|laboratory biomarker analysis|Correlative studies
16318135|NCT00513461|Other|immunoenzyme technique|Correlative studies
16318136|NCT00513461|Other|high performance liquid chromatography|Correlative studies
16318137|NCT00513448|Other|Group wellness intervention|
16318138|NCT00513448|Other|Individualized physical rehabilitation|
16318139|NCT00513435|Drug|saracatinib|Given PO
16318140|NCT00513435|Other|laboratory biomarker analysis|Correlative studies
16318141|NCT00513422|Dietary Supplement|Glucosamine sulphate and chondroitin|"Glucosamine: Two 750mg capsules once daily for two years;
~Chondroitin: Two 400mg capsules once daily for two years."
16318142|NCT00513422|Dietary Supplement|Glucosamine sulphate|"Glucosamine: Two 750mg capsules once daily for two years;
~Placebo Chondroitin: Two capsules once daily for two years."
16318143|NCT00513422|Dietary Supplement|Chondroitin sulphate|"Chondroitin sulphate: Two 400mg capsules once daily for two years;
~Placebo glucosamine: Two capsules once daily for two years."
16318144|NCT00513422|Dietary Supplement|Placebo capsules for glucosamine and chondroitin|"Two placebo glucosamine capsules once daily for two years;
~Two placebo chondroitin capsules once daily for two years."
16318145|NCT00513409|Biological|Synflorix|Intramuscular injection, 1 or 2 doses
16318146|NCT00513409|Biological|Infanrix Hexa|1 Intramuscular injection
16318147|NCT00513409|Biological|Havrix|1 Intramuscular injection
16318148|NCT00513396|Drug|Isoniazid|"High-dose isoniazid (16-18 mg/kg/day) in addition to standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)
~Regular dose isoniazid (5 mg/kg/day) in addition to standard regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)"
16318149|NCT00513396|Drug|Placebo|Similar appearing and similarly packaged placebo tablets in addition to the standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)
16318150|NCT00513383|Drug|Panitumumab|Part A: Intravenously once a week for 7 weeks Part B (Induction Chemotherapy): Intravenously on Day 1 of a 21-day cycle for 3 cycles Part B (After Induction chemotherapy): Intravenously once a week for 7 weeks at the dosing level established during Part A
16318151|NCT00513383|Drug|Carboplatin|Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
16318152|NCT00513383|Drug|Paclitaxel|Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
16318153|NCT00513383|Radiation|Intensity Modulated Radiation Therapy|Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks
16318154|NCT00513383|Drug|5-Fluorouracil|Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles
16318155|NCT00513383|Drug|Docetaxel|Intravenously on day 1 of a 21-day cycle for 3 cycles
16318156|NCT00513383|Drug|Cisplatin|Intravenously on day 1 of a 21-day cycle for 3 cycles
16318157|NCT00513370|Biological|Humira (adalimumab)|Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.
16318158|NCT00513357|Drug|Melatonin|20 mg by mouth daily for 4 Weeks
16318159|NCT00513357|Drug|Placebo|Capsule by mouth daily for 4 Weeks
16318160|NCT00513344|Dietary Supplement|Dark Chocolate|1 portion
16318161|NCT00513344|Dietary Supplement|Milk Chocolate|1 portion
16318162|NCT00513344|Dietary Supplement|"Control (polyphenol-free) Chocolate"|one portion
16318163|NCT00513331|Procedure|Endoscopy|Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
16318164|NCT00513331|Procedure|Radiofrequency ablation protocol|Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
16318165|NCT00513331|Procedure|Endoscopic mucosal resection protocol|Excision of lesion using DUETTE, marketed by Wilson-Cook
16318166|NCT00513305|Drug|Arsenic trioxide|Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.
16318167|NCT00513305|Drug|Low-dose cytarabine alone|Cytarabine will be administered at a dose of 10 mg/m^2 subcutaneously (sc) twice a day (bid).
16318168|NCT00513292|Drug|Cyclophosphamide|Given IV
16318169|NCT00513292|Drug|Epirubicin Hydrochloride|Given IV
16318170|NCT00513292|Other|Laboratory Biomarker Analysis|Correlative studies
16318171|NCT00513292|Drug|Paclitaxel|Given IV
16318172|NCT00513292|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16318173|NCT00513292|Biological|Trastuzumab|Given IV
16318174|NCT00513279|Drug|GSK618334|GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water.
16318175|NCT00513279|Drug|GSK618334 matching placebo tablets|GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water.
16318176|NCT00513266|Biological|bevacizumab|
16318177|NCT00513266|Biological|cetuximab|
16318178|NCT00513266|Drug|fluorouracil|
16318179|NCT00513266|Drug|irinotecan hydrochloride|
16318180|NCT00513266|Drug|leucovorin calcium|
16318181|NCT00513266|Drug|oxaliplatin|
16318182|NCT00513266|Other|laboratory biomarker analysis|
16318183|NCT00513266|Procedure|adjuvant therapy|
16318184|NCT00513266|Procedure|biopsy|
16318185|NCT00513266|Procedure|conventional surgery|
16318186|NCT00513266|Procedure|neoadjuvant therapy|
16318187|NCT00513253|Drug|lapatinib|
16318188|NCT00513240|Drug|Erythropoetin|Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2
16318189|NCT00513240|Drug|Normal saline|"Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.
~."
16318190|NCT00513214|Drug|XOMA 052|"Part 1, Single IV infusion at one of six dose levels (mg/kg).
~Part 2, Single SC injection at one of three dose levels (mg/kg).
~Part 3, Three biweekly SC injections at one of two dose levels (mg/kg)."
16318191|NCT00513214|Drug|Placebo|"Part 1, Single IV infusion at one of six dose levels (mg/kg).
~Part 2, Single SC injection at one of three dose levels (mg/kg).
~Part 3, Three biweekly SC injections at one of two dose levels (mg/kg)."
16318192|NCT00513201|Drug|lyspro|
16318193|NCT00513201|Drug|regular insulin|
16318194|NCT00513188|Biological|denileukin diftitox|
16318195|NCT00513188|Drug|cyclophosphamide|
16318196|NCT00513188|Drug|cytarabine|
16318197|NCT00513188|Drug|doxorubicin hydrochloride|
16318198|NCT00513188|Drug|leucovorin calcium|
16318199|NCT00513188|Drug|methotrexate|
16318200|NCT00513188|Drug|prednisone|
16318201|NCT00513188|Drug|vincristine sulfate|
16318202|NCT00513188|Genetic|protein expression analysis|
16318203|NCT00513188|Other|flow cytometry|
16318204|NCT00513188|Other|laboratory biomarker analysis|
16318205|NCT00513162|Drug|Valproate|Starting Dose of 10 mg/kg By Mouth Daily
16318206|NCT00513162|Drug|Etoposide|25 - 50 mg/m^2 By Mouth Daily
16318207|NCT00513149|Drug|Clopidogrel|Clopidogrel 600 mg loading
16318208|NCT00513136|Behavioral|Group based mind body medicine intervention|Small groups of women (5-15) will participate in 10 weekly sessions that will include learning relaxation and yoga techniques, principles of exercise and nutrition, cognitive behavioral therapy and exploration of common issues and concerns
16318541|NCT00510289|Drug|Sorafenib|400 mg twice a day until progression or unacceptable toxicity develops.
16318209|NCT00513136|Behavioral|Group-based mind body medicine intervention + family focus|In addition to the 10 weekly group-based sessions, women and their key family members will meet twice with a cognitive therapist and family members will participate in selected aspects of the 10 week program.
16318210|NCT00513123|Procedure|Colposcopy|As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.
16318211|NCT00513110|Genetic|AMPD1 polymorphism|Endotoxin 2ng/kg to subjects with a AMPD1 polymorphism
16318212|NCT00513110|Drug|Caffeine infusion|Endotoxin 2ng/kg combined with caffeine. Caffeine (4mg/kg) is used as an adenosine receptor antagonist.
16318213|NCT00513110|Drug|placebo|Endotoxin 2ng/kg combined with saline infusion (0.9%)
16318214|NCT00513097|Behavioral|Smoking Prevention Program|Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.
16318215|NCT00513097|Behavioral|Focus Group|A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.
16318216|NCT00513097|Behavioral|Survey|On-line evaluations and questionnaires
16318217|NCT00513084|Behavioral|SDT and Motivational Interviewing in Obesity Treatment|Thirty group sessions, designed to follow SDT, covering PA, eating/nutrition, body image, and other cognitive-behavioral contents. Central to the intervention are improving autonomy, intrinsic motivation, and self-regulation of behavior change. Accepting ambivalence for change, rolling with resistance, and developing discrepancy were used throughout the program, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control.
16318218|NCT00513071|Drug|saracatinib|Given orally
16318219|NCT00513071|Other|laboratory biomarker analysis|Correlative studies
16318220|NCT00513058|Drug|Lapatinib|Dose level (DL) 1 : 750 mg/d DL2, DL3, DL4: 1000 mg/d DL5, DL7, DL8: 1250 mg/d DL6: 1500 mg/d
16318221|NCT00513058|Drug|vinorelbine|DL1, DL2: 20 mg/m2 DL3: 22.5 mg/m2 DL4, DL5, DL6: 25 mg/m2 DL7: 27.5 mg/m2 DL8: 30 mg/m2
16318222|NCT00513045|Behavioral|IRT|Cognitive behavior intervention
16318223|NCT00513045|Behavioral|Exposure|Exposure intervention
16318224|NCT00513032|Drug|methylene blue|5mg.kg-1 methylene blue in 250 ml 5% glucose-saline, administered intravenously approximately 60 min before anaesthesia induction
16318225|NCT00513019|Drug|Lamictal (lamotrigine)|once daily from beginning to end of study. Dosage varies.
16318226|NCT00513019|Drug|Placebo|daily
16318227|NCT00512993|Drug|Zoledronic acid|Infusion of zoledronic acid (4 mg) every 4 weeks for six doses, followed by every 3 months for 8 doses, followed by every 6 months for 5 doses
16318228|NCT00512980|Drug|prednisone|
16318229|NCT00512980|Drug|vinblastine|
16318230|NCT00512980|Drug|doxorubicin|
16318231|NCT00512980|Drug|gemcitabine|
16318232|NCT00512928|Drug|acenocoumarol|max 5 mg per day during 10 weeks
16318233|NCT00512928|Dietary Supplement|menaquinone-7|In successive weeks (6 weeks) the dosage is increased over the range 10 µg to 20 µg increasing to 45 µg MK-7 for the final week.
16318234|NCT00512915|Device|pacemaker implantation|St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer
16318235|NCT00512902|Drug|Imatinib|All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits.
16318236|NCT00512902|Drug|Imatinib|Up to 600 mg QD PO for up to 1 year.
16318237|NCT00512889|Biological|therapeutic autologous lymphocytes|Autologous CTL generated from peripheral blood following culture with MART1/Melan-A peptide pulsed aAPC.
16318238|NCT00512889|Genetic|Use of an artificial antigen presenting cell (aAPC) to generate CTL|A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
16318239|NCT00512889|Drug|GM-CSF|GM-CSF will be used as an immune activator and combined with the infusion of MART1/Melan-A specific CTL.
16318240|NCT00512889|Radiation|Irradiation of cutaneous tumor lesion|Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.
16318241|NCT00512876|Drug|Bevacizumab (Avastin)|Bevacizumab 10mg/mL 1 drop BID x 3 weeks
16318242|NCT00512863|Drug|Humira (adalimumab)|
16318243|NCT00512850|Dietary Supplement|Folic acid|Intervention group 1g folic acid per day
16318244|NCT00512850|Other|Placebo|One placebo pill per day
16318245|NCT00512837|Behavioral|Mobile phone technology|
16318246|NCT00512824|Dietary Supplement|low calcium milk of 180 ml|twice daily for 24 weeks
16318247|NCT00512824|Dietary Supplement|regular milk of 180 ml|twice daily for 24 weeks
16318248|NCT00512824|Dietary Supplement|regular milk of 180 ml + probiotics|twice daily for 24 weeks
16318249|NCT00512824|Dietary Supplement|regular milk of 180 ml + probiotics|twice daily for 24 weeks
16318250|NCT00512811|Drug|furosemide|
16318251|NCT00512798|Drug|PS-341 (VELCADE)|"Dose Levels PS-341 (day 1)
~Level -1 0.7 mg/m2
~Level 1 1.0 mg/m2
~Level 2 1.0 mg/m2
~Level 3 1.3 mg/m2
~Level 4 1.5 mg/m2"
16318252|NCT00512798|Drug|temozolomide|"Temozolomide (day 8)
~Level - 1 50 mg/m2
~Level 1 50 mg/m2
~Level 2 75/mg/m2
~Level 3 75 mg/m2
~Level 4 75 mg/m2"
16318253|NCT00512798|Other|immunoenzyme technique|Not noted
16318254|NCT00512798|Drug|PS-341 (VELCADE)|1.3 mg/m2 by IV on days 1, 4, 8, and 11 of every 21 days
16318255|NCT00512798|Drug|Temozolomide|75 mg/m2 by mouth, daily, during weeks 2-8 (42 days) of every 9-week course.
16318256|NCT00512785|Drug|imidafenacin, KRP-197/ONO-8025|0.1 mg BID for 52 weeks
16318257|NCT00512785|Drug|imidafenacin, KRP-197/ONO-8025|0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks
16318258|NCT00512759|Drug|Goal-directed preload and afterload decrement|Early goal-directed preload and afterload decrement with a target systolic blood pressure (RR) of 90-110 mmHg for the entire hospitalization using sublingual nitrates (Nitroglycerin Streuli®) or nitrospray (Corangin Nitrospray®) transdermal nitrates (Nitroderm TTS 10®), ACE-inhibitors (Triatec®) and/or ARB (Atacand®).
16318259|NCT00512746|Other|cytology and cytometry specimen collection procedure|Samples tested and further interventions added if positive
16318260|NCT00512746|Other|Chest x ray|Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
16318261|NCT00512746|Procedure|Autofluorescence bronchoscopy|The bronchial tree will be inspected first under white light and then under blue light. All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
16318262|NCT00512746|Procedure|CT scan|All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
16318263|NCT00512707|Drug|Sildenafil citrate (open label)|On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
16318264|NCT00512707|Drug|Testosterone gel|Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
16318265|NCT00512707|Other|Placebo gel|3 tubes of placebo gel equivalent to the amount of the testosterone gel will be applied during the placebo-controlled testosterone gel intervention for 16 weeks..
16318266|NCT00512681|Drug|Irinotecan, Oxaliplatin, TS-1|"S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
~Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1
~Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1"
16318267|NCT00512668|Drug|leuprolide acetate|Given intramuscularly
16318268|NCT00512668|Drug|goserelin acetate|Given subcutaneously
16318269|NCT00512668|Drug|bicalutamide|Given PO
16318270|NCT00512668|Drug|nilutamide|Given PO
16318271|NCT00512668|Drug|flutamide|Given PO
16318272|NCT00512668|Drug|temsirolimus|Given IV
16318273|NCT00512668|Other|laboratory biomarker analysis|Optional correlative studies
16318274|NCT00512655|Behavioral|Fall prevention course|Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.
16318275|NCT00512629|Drug|Omegaven|Omegaven is a fish based intravenous fat emulsion
16318276|NCT00512629|Drug|Intralipid|Intralipid is a plant based intravenous fat emulsion
16318277|NCT00512616|Drug|Ceftriaxone|
16318278|NCT00512590|Behavioral|Relaxation and Guided Imagery|"The intervention consisted of 3 relaxation and guided imagery audiotapes used in a proscribed order for 6 weeks and used in any order for weeks 7 through 10.
~Protocol: Tape 1: Basic Relaxation used for weeks 1 and 2. Tape 2: Pleasant Scene Imagery to elicit sensory involvement for enhanced sense of overall well-being; used for weeks 3 and 4. Tape 3: End-State Imagery designed to facilitate improved symptom management; used for weeks 5 and 6. Any of the tapes used as often as desired but at least once daily for weeks 7 to 10."
16318279|NCT00512577|Other|Red cell blood transfusion|
16318280|NCT00512564|Other|Laboratory analyses of iron overload|Summary of clinical status related to iron overload and laboratory analysis of Iron overload including Total serum Iron, Transferrin, Ferritin and Non transferrin Binding Iron and Labile Plasma Iron
16318281|NCT00512551|Procedure|Tumor Biopsies|Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.
16318282|NCT00512538|Device|Bi-layered cell therapy (Apligraf)|
16318283|NCT00512525|Drug|Ghrelin and saline (as placebo)|Intravenous infusion
16318284|NCT00512512|Procedure|Transoral Endoscopic Liver Biopsy|Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass
16318285|NCT00512499|Behavioral|Control group|Informing patient that fracture probably of fragility origin and suggesting to consult primary care practitioner. After 8 months, if not treated, Intensive intervention will be offered
16318286|NCT00512499|Behavioral|Minimal Intervention|Multiple layers of intervention will be added: results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
16318287|NCT00512499|Behavioral|Intensive Intervention|"INTENSIVE INTERVENTION GROUP: 1/2 of patients, randomly selected results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
~Sequential serum will be stored frozen in order to measure levels of blood markers of bone metabolism (at a later date)"
16318288|NCT00512486|Biological|MEDI-563|"BIW-8405/MEDI-563 administered at one of five dose levels:
~0.03 mg/kg intravenous injection
~0.1 mg/kg intravenous injection
~0.3 mg/kg intravenous injection
~1.0 mg/kg intravenous injection
~3.0 mg/kg intravenous injection
~Following the -3.0 mg/kg dose level,
~BIW-8405/MEDI-563 administered at one of two lower dose levels:
~0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection"
16318289|NCT00512473|Drug|Saline infusion|0.9 % NaCl
16318290|NCT00512473|Drug|Human Growth Hormone|0.5 mg genotropin administered as a bolus at t = 0
16318291|NCT00512473|Drug|Pegvisomant|30 mg Somavert administered at t = - 36 hours
16318292|NCT00512460|Drug|RTA 744|4.8 mg/m^2 by vein Over 2 Hours On Days 1-3.
16318293|NCT00512434|Procedure|Osteosynthesis|Nail or external fixator Intervention 'Osteosynthesis'
16318294|NCT00512421|Procedure|computer-assisted surgery|
16318295|NCT00512408|Drug|testosterone|
16318296|NCT00512395|Drug|epidural analgesia (Duracain/Fentanyl/Naropin)|naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h
16318629|NCT00509626|Other|questionnaire administration|
16318630|NCT00509626|Procedure|CAM exercise therapy|
16318297|NCT00512382|Device|WEEM - Wheezy Monitoring|loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
16318298|NCT00512356|Biological|Anti-Adhesion Product|Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.
16318299|NCT00512317|Drug|ganaxolone|liquid suspension dosed tid
16318300|NCT00512304|Procedure|association chemotherapy and radiochemotherapy|
16318301|NCT00512291|Drug|Olanzapine|5 mg subcutaneous injection every 8 hours for 9 doses. Each injection should take about 1 to 2 minutes.
16318302|NCT00512278|Drug|Infliximab|Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
16318303|NCT00512278|Drug|Placebo|Placebo
16318304|NCT00512265|Drug|n-acetylcysteine|150mg/kg N-Acetylcysteine in 250mL Glucose 5% at time of induction of anaesthesia 50mg/kg N-Acetylcysteine in 250mL Glucose 5% on post-op days 1-3
16318305|NCT00512265|Drug|250mL glucose 5%|placebo (250mL glucose 5%) at time of induction of anaesthesia placebo (250mL glucose 5%) on post-op days 1-3
16318306|NCT00512252|Drug|AMD3100|
16318307|NCT00512252|Drug|Mitoxantrone|
16318308|NCT00512252|Drug|Etoposide|
16318309|NCT00512252|Drug|Cytarabine|
16318310|NCT00512226|Other|Cardiac and Liver T2* MRI|Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.
16318311|NCT00512213|Dietary Supplement|Immunonutrition for 5 days preoperative|Impact vs Meritene
16318312|NCT00512213|Dietary Supplement|Standard enteral nutrition for 5 days preoperative|Impact vs Meritene
16318313|NCT00512187|Other|low calorie diet|Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein
16318314|NCT00512174|Other|BladderScan BVI 3000|
16318315|NCT00512148|Device|Autologous neobladder construct|augmentation cystoplasty with autologous neo-bladder construct
16318316|NCT00512135|Drug|IncobotulinumtoxinA (Xeomin) (20 units)|Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
16318317|NCT00512122|Other|Withholding PN during the first week of ICU stay|Patients in this arm will receive exclusively enteral nutrition. If enteral nutrition is insufficient after the seventh day of ICU stay, parenteral nutrition will be started.
16318318|NCT00512122|Drug|Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E|PN will be started the morning of the third ICU hospitalisation day. The amount of PN to be given will be calculated to cover the caloric needs of the patient, based on the enteral energy intake the previous 24 hours.
16318319|NCT00512096|Drug|Ifosfamide|1200 mg/m^2 By Vein Over 2 Hours on Days 1-3
16318320|NCT00512096|Drug|Paclitaxel (Taxol)|175 mg/m^2 By Vein Over 3 Hours on Day 1
16318321|NCT00512096|Drug|Cisplatin|25 mg/m^2 By Vein Over 2 Hours on Days 1-3
16318322|NCT00512083|Drug|AS1411|AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
16318323|NCT00512070|Drug|olanzapine and melatonin|In treatment phase I, all subjects will receive olanzapine, 10-25 mg/day. In treatment phase II, all subjects will receive olanzapine (10-25 mg/day) plus melatonin. Subjects will be randomized at a ratio of 1:1 to receive melatonin, 0.3 mg/day or 3.0 mg/day. Group IIA will receive 0.3mg day melatonin. Group IIB will receive 3.0 mg/day melatonin.
16318324|NCT00512057|Drug|allopurinol|allopurinol 300mg twice a day
16318325|NCT00512057|Drug|placebo|placebo
16318326|NCT00512044|Procedure|Local anesthesia (pudendal block)|local anesthesia as indicated
16318327|NCT00512044|Procedure|general anesthesia (spinal and general)|general according to guidelines
16318328|NCT00512018|Device|NMES|"In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES limbs).For the NMES, a symmetric double-phase sine-wave was used. Bearing wave frequency was of 2500 Hz, modulated in 50 bursts/s, with pulse duration of 200 µs, interburst interval of 10 ms. This configuration is known as Russian current."
16318329|NCT00512018|Other|Isokinetic exercise|Subjects realized training sessions twice a week with a 2-day minimum interval between the sessions, for 4 weeks. Each session included 5 min period of warm-up in a stationary bicycle, followed by 3 series of quadriceps stretching, as previously described. After being positioned at the isokinetic dynamometer, just as in the evaluation sessions, subjects firstly performed 3 sets of 10 maximum isokinetic concentric repetitions at the speed of 30º/s with one limb (EX limb), respecting the rest interval of 3 minutes between the sets.
16318330|NCT00512005|Device|Percutaneous mitral valve repair|Ventricular reshaping to treat functional mitral insufficiency
16318331|NCT00511992|Drug|Avastin|"Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
~Consolidation Treatment:
~Avastin 15mg/kg IV every 21 days x 12 cycles"
16318332|NCT00511992|Drug|Paclitaxel|Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
16318333|NCT00511992|Drug|Cisplatin|75mg/m2 IP day 2 every 21 days x 6 cycles
16318334|NCT00511979|Drug|Technosphere Insulin|
16318335|NCT00511979|Drug|Technosphere insulin|
16318336|NCT00511979|Drug|Technosphere insulin|
16318337|NCT00511979|Drug|Regular human insulin|
16318338|NCT00511966|Other|Non-Pharmacologic Treatment|Non-Pharmacologic Treatment
16318339|NCT00511966|Drug|Rabeprazole|As prescribed
16318340|NCT00511953|Drug|Gabapentin Extended Release tablets|1800mg
16318341|NCT00511953|Drug|Gabapentin|1800mg
16318342|NCT00511940|Drug|acamprosate|999 mg/day - 2997 mg/day, oral
16318343|NCT00511940|Other|placebo|oral, placebo
16318344|NCT00511914|Biological|cTIV|One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle
16318345|NCT00511901|Drug|placebo|
16318346|NCT00511901|Drug|epoetin alpha|
16318347|NCT00511901|Drug|Niferex|
16318348|NCT00511875|Drug|doxycycline monohydrate|50mg once daily for 24 months
16318350|NCT00511862|Device|Yttrium 90 glass microspheres|120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
16318351|NCT00511849|Drug|carboplatin + SU011248 (sunitinib) + paclitaxel|AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.
16318352|NCT00511836|Drug|VIVITROL 380 mg|Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension.
16318353|NCT00511836|Drug|Placebo|Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.
16318354|NCT00511823|Drug|casopitant|The doses of casopitant will be comprised of 150 mg (one 150 mg tablet) and 50 mg (one 50 mg tablet). Casopitant will be taken with 240 milliliters (mL) of water on an empty stomach following at least 2 hour fast.
16318355|NCT00511823|Drug|dolasetron|The dose of oral dolasetron will be comprised of 100 mg (one 100 mg tablet or two 50 mg tablets). Dolasetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
16318356|NCT00511823|Drug|granisetron|The dose of oral granisetron will be comprised of 2 mg (two 1 mg tablets). Granisetron will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
16318357|NCT00511823|Drug|rosiglitazone|The dose of oral rosiglitazone will be comprised of 4 mg (two 2 mg tablets or one 4 mg tablet). Rosiglitazone will be taken with 240 mL of water on an empty stomach following at least 2 hour fast.
16318358|NCT00511810|Drug|Low Dose Fish Oil|Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
16318359|NCT00511810|Drug|High Dose Fish Oil|Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
16318360|NCT00511797|Drug|SH T04740B|Drospirenone 1mg/EE 20µg (ß-CDC)
16318361|NCT00511797|Drug|SH T00186DF|Drospirenone 3 mg/EE 20µg (ß-CDC)
16318362|NCT00511797|Drug|SH T04740F|Drospirenone 2 mg/EE 20µg (ß-CDC)
16318363|NCT00511797|Drug|Placebo|Placebo
16318364|NCT00511771|Drug|Tegaserod|Tegaserod maleate
16318365|NCT00511758|Procedure|Digital Imaging|Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
16318366|NCT00511745|Drug|Rabeprazol|As prescribed
16318367|NCT00511732|Drug|Technosphere Insulin|Technosphere Insulin Inhalation Powder
16318368|NCT00511732|Drug|Technosphere Placebo|Technosphere Inhalation Powder
16318369|NCT00511719|Drug|Technosphere Insulin|48U
16318370|NCT00511719|Drug|Actrapid|24IU
16318371|NCT00511706|Drug|dexamethasone|Intravitreal injection of dexamethasone 700 µg at Day 1.
16318372|NCT00511706|Biological|ranibizumab|Ranibizumab 500 µg at day -30 and Day 7-14.
16318373|NCT00511706|Other|sham|Sham needle-less injection administered in the study eye at Day 1.
16318374|NCT00511693|Behavioral|centralized osteoporosis coordinator|The regional osteoporosis coordinator will phone fracture patients and counsel them about their risk of osteoporosis, reiterating messages in the print material. The coordinator will also follow-up with family physicians by phone and send them a patient-specific reminder that informs them that their patient has experienced a fracture and they are at high risk for future fracture. As part of the reminder, a set of evidence-based recommendations about appropriate BMD testing and treatment based on the recent Canadian guidelines will be included. If the patient does not have a family physician, the regional osteoporosis coordinator will facilitate referral to the MOP.
16318375|NCT00511693|Behavioral|fall prevention|Fracture patients from hospitals receiving falls prevention advice will also be called by the osteoporosis regional coordinator. The patient will receive educational material and telephone counseling regarding fall prevention. During the call, patients will be encouraged to visit their family physician for fracture follow-up. They will not receive counseling or educational materials about osteoporosis at this time. Patients in the falls prevention group will receive the physician and patient osteoporosis program six months post-fracture.
16318376|NCT00511680|Behavioral|Behavioral Based In-Home Intervention|The 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research.
16318377|NCT00511667|Drug|MK0941|MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
16318378|NCT00511667|Drug|Comparator: Placebo|Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
16318379|NCT00511654|Drug|GW823296 tablet|GW823296 immediate release tablets will be available as white film-coated tablets containing 5 milligrams (mg) and 20 mg of GW823296 for oral administration.
16318380|NCT00511654|Drug|GW823296 matching placebo|Matching placebo tablets will be identical in appearance to the GW823296 tablets.
16318381|NCT00511654|Drug|Midazolam|Midazolam will be administered as 5 milliliter (mL) of an intravenous solution for oral application (5 mg/5 mL, Dormicum).
16318382|NCT00511641|Behavioral|Questionnaire|Questionnaires lasting up to 30 minutes.
16318383|NCT00511628|Drug|Risperidone|As prescribed
16318384|NCT00511615|Procedure|Loop Electrosurgical Excision Procedure (LEEP)|Tissue sample removed from cervix using LEEP and contrast agent.
16318385|NCT00511602|Drug|Technosphere Insulin|Technosphere Insulin Inhalation Powder
16318386|NCT00511602|Drug|Technosphere Placebo|Technosphere Inhalation Powder
16318387|NCT00511589|Other|chagas disease diagnostic|
16318388|NCT00511576|Drug|MGCD0103 & Docetaxel|"In both Parts 1 and 2, subsequent doses of MGCD0103 will be escalated in 25 mg increments until the MTD of MGCD0103 in combination with each fixed dose (60 mg/m2 or 75 mg/m2) ofIV docetaxel is determined.
~In both parts 1 and 2, MGCD0103 will be administered orally TIW for 3 weeks beginning on Day 1 at 1 hour prior to the start of the IV docetaxel infusion.
~There will be no scheduled break between cycles and no limit to the number of cycles a subject can receive provided they do not have disease progression as defined by RECIST, or a clinically significant drug-related adverse event (AE) that does not resolve or respond to treatment intervention with 3 weeks."
16318390|NCT00511524|Drug|GW842166X|GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.
16318391|NCT00511524|Drug|[carbonyl-^11C]GW842166|[carbonyl-^11C]GW842166 will b available as Intravenous solution.
16318392|NCT00511498|Drug|Sildenafil|50 mg daily at bedtime
16318393|NCT00511485|Drug|Vintafolide|Induction: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: vintafolide 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.
16318394|NCT00511485|Drug|Etarfolatide|
16318395|NCT00511472|Drug|MK-0941|"In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
~Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2."
16318396|NCT00511472|Drug|Placebo|10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
16318397|NCT00511472|Drug|LANTUS insulin|LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
16318398|NCT00511459|Drug|AMG 386 Placebo|AMG 386 Placebo [blinded]
16318399|NCT00511459|Drug|AMG 386|AMG 386 3mg/kg IV QW [blinded]
16318400|NCT00511459|Drug|Bevacizumab|Bevacizumab 10mg/kg IV Q2W
16318401|NCT00511459|Drug|AMG 386|AMG 386 10mg/kg IV QW [Open-Label]
16318402|NCT00511459|Drug|AMG 386|AMG 386 10mg/kg IV QW [blinded]
16318403|NCT00511459|Drug|Paclitaxel|Paclitaxel 90mg/m2 IV QW (3 on/1 0ff)
16318404|NCT00511446|Drug|docetaxel, oxaliplatin, capecitabine|"Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16318405|NCT00511433|Drug|NOMAC-E2|"Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28
~for 6 consecutive 28-day menstrual cycles."
16318406|NCT00511433|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
16318407|NCT00511420|Dietary Supplement|Cocoa product type 1|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
16318408|NCT00511420|Dietary Supplement|Cocoa product type 2|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
16318409|NCT00511420|Dietary Supplement|Cocoa product type 3|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
16318410|NCT00511420|Dietary Supplement|Cocoa product type 4|6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
16318411|NCT00511407|Device|Renal tubule assist device|Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
16318412|NCT00511394|Drug|20% Human Albumin|Infusion of 100 mL of 20% Albumin over 3 hours
16318413|NCT00511394|Drug|Normal Saline|Infusion of 100 mL of Normal Saline
16318414|NCT00511381|Genetic|No intervention|No intervention
16318415|NCT00511368|Drug|matching placebo|
16318416|NCT00511368|Drug|Bevirimat|
16318417|NCT00511355|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
16318418|NCT00511355|Drug|Levonorgestrel and Ethinyl Estradiol|Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
16318419|NCT00511342|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
16318420|NCT00511342|Drug|LNG-EE|Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
16318421|NCT00511329|Drug|somatropin [rDNA origin] for injection|Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
16318422|NCT00511316|Drug|Montelukast/ Singulair|20 mg daily for six months
16318423|NCT00511316|Drug|Placebo|Placebo 20 mg daily for 6 months
16318424|NCT00511303|Drug|STI571|
16318425|NCT00511290|Other|no generic names|
16318426|NCT00511277|Drug|Seroquel®|dosage form: oral, dosage: 300-800mg/d, frequency: twice daily
16318427|NCT00511238|Drug|carfilzomib|Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered.
16318428|NCT00511238|Drug|carfilzomib|Subjects will receive carfilzomib intravenously over up to 10 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. In cycle 1, the dose is 20 mg/m2. If all doses are administered and well-tolerated over Cycle 1, beginning with Cycle 2 the dose will escalate to 27 mg/m2 cycle. A maximum of 12 cycles will be administered.
16318429|NCT00511225|Dietary Supplement|cholecalciferol|10,000 IU weekly
16318430|NCT00511225|Dietary Supplement|placebo|placebo capsule
16318431|NCT00511212|Drug|intravenous immunoglobulin|
16318432|NCT00511199|Drug|NOMAC-E2|"Nomegestrol Acetate and Estradiol Tablets, 2.5 mg
~NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year)."
16318433|NCT00511199|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
16318434|NCT00511186|Drug|Placebo|placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.
16318435|NCT00511186|Drug|BIAP|AP is administered intravenously over 48 hours. An initial loading dose of 67.5U/Kg body weight over 10-minutes is followed by continuous infusion of 132.5U/Kg/24H administered over 48H
16318436|NCT00511173|Genetic|Warfarin Dose based on pharmacogenetics|Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
16318437|NCT00511160|Procedure|Myocardial biopsies with TRU CUT 14 Gauge needle|Myocardial needle biopsy and right atrial appendectomy
16318438|NCT00511160|Procedure|Endomyocardial biopsies|The control arm C consists of routine-workup of patients with suspected myocarditis, independent of the study arm C, but with analogous screening methods and comparable biopsy sampling
16318439|NCT00511147|Biological|IGIV3I Grifols 10%|IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
16318440|NCT00511134|Drug|Eszopiclone|eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule
16318441|NCT00511134|Drug|Bupropion|bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.
16318442|NCT00511121|Drug|STI571 and PEG INTRON|
16318443|NCT00511108|Drug|Comparator: sitagliptin phosphate|sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
16318444|NCT00511108|Drug|Comparator: pioglitazone|pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
16318445|NCT00511108|Drug|Comparator: placebo to pioglitazone|pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
16318446|NCT00511108|Drug|Comparator: placebo to sitagliptin|sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
16318447|NCT00511095|Biological|HEPLISAV|Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
16318448|NCT00511082|Drug|OPB-31121|Patients will receive OPB-31121 administered orally, once daily for 4 weeks.
16318449|NCT00511069|Drug|Bortezomib|
16318450|NCT00511043|Drug|PTK787|PTK787 - 1250mg p.o. daily. Initial dose of 750mg p.o daily starting on day 1 and increased weekly to an intermediate dose of 1000 mg and then a target dose of 1250mg unless a grade ≥ 2 toxicity. Patients who tolerate the study target dose of 1250mg will remain on that dose until study completion at 12 months or until disease progression, unacceptable toxicity, withdrawal of consent or patient non-compliance with the protocol requirement.
16318451|NCT00511017|Drug|Doxercalciferol|.05 mcg/kg by mouth daily x 28 Days
16318452|NCT00511004|Drug|Albendazole|Comparing 400 mg to 800 mg dose
16318453|NCT00511004|Drug|Diethylcarbamazine|Providing diethylcarbamazine more frequently in combination with albendazole
16318454|NCT00510991|Device|nippv|
16318455|NCT00510978|Biological|Bifidobacterium infantis 35624|1 sachet/day for one year
16318456|NCT00510978|Biological|Lactobacillus salivarius UCC118|1 sachet per day for 1 year
16318457|NCT00510978|Biological|Placebo|1 sachet per day for 1 year
16318458|NCT00510965|Drug|Intravitreal injection ranibizumab|Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year
16318459|NCT00510952|Drug|Insulin Lispro Protamine Suspension|Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
16318460|NCT00510952|Drug|Insulin Glargine|Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
16318461|NCT00510939|Drug|Tipifarnib plus Bortezomib|
16318462|NCT00510926|Drug|Imatinib Mesilate (Glivec)|
16318463|NCT00510913|Drug|tacrolimus|
16318464|NCT00510887|Drug|Bortezomib|Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
16318465|NCT00510887|Drug|Rituximab|Rituximab 375 mg/m2 IV on day 1
16318466|NCT00510887|Drug|Fludarabine|Fludarabine 25 mg/m2 IV on days 1,2,3
16318467|NCT00510887|Drug|Mitoxantrone|Mitoxantrone 10 mg/m2 IV on day 2
16318468|NCT00510887|Drug|Dexamethasone|Dexamethasone 20 mg orally on days 1,2,3,4,5
16318469|NCT00510874|Biological|Pumarix™|Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
16318470|NCT00510874|Biological|Pandemrix ™|Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
16318471|NCT00510848|Procedure|autograft tendon|Reconstruction with an autograft tendon (hamstrings)
16318472|NCT00510848|Procedure|allograft tendon|Reconstruction with an allograft tendon (tibialis posterior)
16318473|NCT00510835|Procedure|Early Goal Directed Therapy (EGDT)|Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements.
16318474|NCT00510835|Procedure|Protocolized Standard Care (PSC)|Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status.
16318475|NCT00510835|Procedure|Usual Care (UC)|Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices.
16318476|NCT00510822|Drug|Cimicoxib|50 mg per tablet, bid (total daily dose 100 mg)
16318477|NCT00510822|Drug|Placebo|tablet
16318478|NCT00510809|Drug|Policosanol|Policosanol 20 mg daily
16318479|NCT00510809|Other|Placebo|Placebo daily
16318480|NCT00510809|Drug|Policosanol Plus Already In Use Statin Therapy|Policosanol 20 mg daily Statin Therapy
16318481|NCT00510796|Behavioral|Interview|Interview regarding perception of pain and the benefits and barriers to the combined screening.
16318482|NCT00510783|Drug|Keppra|The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes.
16318483|NCT00510783|Drug|Fosphenytoin|IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals.
16318631|NCT00509626|Procedure|management of therapy complications|
16318484|NCT00510783|Drug|Dilantin|IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals.
16318485|NCT00510770|Device|CPAP application|
16318486|NCT00510744|Drug|pancreatic enzyme supplement|4 caps with meals, 2 with snacks
16318487|NCT00510718|Drug|MDV3100|MDV3100 daily until progression or dose-limiting toxicity
16318488|NCT00510705|Other|exercise training|physical exercise training on a bicycle ergometer daily for 4 weeks
16318489|NCT00510705|Other|exercise training + metformin|physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
16318490|NCT00510705|Other|exercise training + glitazone|physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
16318491|NCT00510692|Drug|Eicosapentanoic Acid (EPA)|2 x 500mg EPA capsules twice daily for 6 months
16318492|NCT00510692|Procedure|Endoscopy|Endoscopy with video and photographs at baseline and month 6.
16318493|NCT00510692|Procedure|Biopsies taken|9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
16318494|NCT00510692|Drug|Placebo|2 x 500mg placebo capsules twice daily for 6 months
16318495|NCT00510679|Behavioral|Health worker supports (supervision, job aids, incentives)|
16318496|NCT00510666|Drug|Saline|Saline infusion adjunct to morphine PCA pump
16318497|NCT00510666|Drug|Butorphanol tartrate|Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
16318498|NCT00510666|Drug|Tramadol Hydrochloride|100mg tramadol was used preemptively to morphine PCA pump
16318499|NCT00510666|Drug|Saline|Preemptive saline as a control group to tramadol one
16318500|NCT00510653|Drug|Imatinib Mesylate|600 mg by mouth daily for 6 Weeks
16318501|NCT00510640|Drug|Sunitinib|Capsule, 12.5 or 50 mg, starting dose level 50 mg daily
16318502|NCT00510627|Device|Radiofrequency Ablation (RFA)|The RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue.
16318503|NCT00510627|Drug|Chemotherapy|Standard of care chemotherapy regimen
16318504|NCT00510614|Drug|tinidazole|1 gram twice weekly for 12 weeks
16318505|NCT00510614|Drug|Placebo|one pill twice weekly for 12 weeks
16318506|NCT00510601|Device|Kaneka Liposorber|LDL-apheresis on a bi-weekly basis
16318507|NCT00510588|Other|training|regular physical exercise training for 6 months
16318508|NCT00510588|Other|training + metformin|regular physical exercise training in combination with metformin for 6 months
16318509|NCT00510588|Other|training + glitazon|regular physical exercise training in combination with a glitazon for 6 months
16318510|NCT00510575|Device|Spinal rod|Posterior spinal fusion using a 5.5 or 6.35 size rod
16318511|NCT00510562|Procedure|Cranial osteopathic manipulation|This treatment is performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
16318512|NCT00510562|Procedure|Sham/Placebo|A laying on of hands with no treatment being performed.
16318513|NCT00510549|Procedure|Modality: Peritoneal Dialysis|Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
16318514|NCT00510536|Drug|Acetaminophen|dose to be determined by investigator
16318515|NCT00510536|Drug|NSAID|dose to be determined by investigator
16318516|NCT00510523|Device|Whole Body Vibration machine|
16318517|NCT00510510|Drug|NVA237 100 µg|Dry powder inhalation once a day for up to 28 days
16318518|NCT00510510|Drug|Placebo|Placebo to NVA237 dry powder inhalation once a day for up to 28 days
16318519|NCT00510510|Drug|NVA237 200 µg|Dry powder inhalation once a day for up to 28 days
16318520|NCT00510497|Biological|Autologous HIV-1 ApB DC Vaccine|Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
16318521|NCT00510484|Drug|Pancrelipase Delayed Release|24000 unit Capsule
16318522|NCT00510484|Drug|Placebo Comparator|Placebo
16318523|NCT00510471|Drug|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16318524|NCT00510458|Device|LFIT™ Femoral Heads With X3® Insert|LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
16318525|NCT00510445|Drug|Imetelstat Sodium (GRN163L)|"The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg.
~Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle."
16318526|NCT00510419|Drug|"InvestigationalAuto-injector (sumatriptan succinate)"|
16318527|NCT00510406|Drug|tamsulosin hydrochloride|Alphablocker
16318528|NCT00510406|Drug|solifenacin succinate|antimuscarinic
16318529|NCT00510406|Drug|Placebo|Placebo
16318530|NCT00510393|Device|XIENCE V everolimus eluting coronary stent system|
16318531|NCT00510393|Device|MULTILINK VISION coronary stent system|
16318532|NCT00510367|Drug|5-Fluorouracil|500 mg/m^2 By Vein Daily x 2 Days
16318533|NCT00510367|Drug|Cyclophosphamide|500 mg/m^2 By Vein On Day 1
16318534|NCT00510367|Drug|Doxorubicin|50 mg/m^2 By Vein Over 72 Hours
16318535|NCT00510354|Drug|Imatinib mesylate|
16318536|NCT00510341|Behavioral|Collaborative Management in Pediatrics (CMP) Program|Pediatric residents will receive two 4.5 hour training sessions on the CMP Program.
16318537|NCT00510328|Device|Whole Body Vibration|
16318538|NCT00510315|Other|Questionnaires, Laboratory tests, Abdominal MRI|Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement
16318539|NCT00510302|Behavioral|Questionnaire|Questionnaire regarding melanoma risk-reduction.
16318540|NCT00510302|Behavioral|Interview|Interview via telephone about topics related to melanoma risk-reduction.
16318542|NCT00510276|Drug|Atomoxetine hydrochloride|20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
16318543|NCT00510276|Drug|Placebo|twice a day, by mouth for 12 weeks
16318544|NCT00510263|Drug|Prednisolone + placebo|Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
16318545|NCT00510263|Drug|Valaciclovir + placebo|Valaciclovir 500 mg 2 tablets 3 times daily for 7 days. Placebo tablets 12 per day for 5 days, tapering 2 tablets per day until day 10.
16318546|NCT00510263|Drug|Prednisolone + valaciclovir|Prednisolone 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Valaciclovir 500 mg 2 tablets 3 times daily for 7 days.
16318547|NCT00510263|Drug|Placebo + placebo|Placebo 5 mg 12 tablets per day for 5 days, tapering 2 tablets per day until day 10. Placebo 2 tablets 3 times daily for 7 days.
16318548|NCT00510250|Drug|Sorafenib|200mg PO BID x 7 days prior to Radiation and Cisplatin for Low-Risk Patients or 200mg PO BID x 7 days prior to, and 35 days during Radiation and Cisplatin for High-Risk Patients
16318549|NCT00510250|Drug|Cisplatin|40mg/m2 administered weekly via IV, with Radiation
16318550|NCT00510250|Procedure|Radiation|Administered for 30-40 days.Combination of external beam radiotherapy followed by intra-cavitary brachytherapy.
16318551|NCT00510237|Behavioral|"Adolescents Coping, Connecting, Empowering, and Protecting Together (Project ACCEPT)"|The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
16318552|NCT00510224|Drug|Sandostatin|Sandostatin 30mg intramuscular every 28 days
16318553|NCT00510211|Drug|olanzapine|
16318554|NCT00510198|Device|Cardiac Compass with OptiVol Fluid Status Monitoring|Review of Cardiac Compass with OptiVol Fluid Status Monitoring
16318555|NCT00510198|Device|Standard of Care alone (clinical assessment)|Clinical assessment utilizing standard of care, alone.
16318556|NCT00510185|Other|systematic coronary intervention|Coronary angiography within 72 hrs
16318557|NCT00510185|Other|coronary intervention only for cases refractory to medical therapy|Initially conservative treatment with coronary angiography only for recurrent ischemia
16318558|NCT00510172|Drug|Prostacyclin, PGI2|10 ng/kg/min of epoprostenol (stable PGI2)
16318559|NCT00510172|Drug|Placebo|NaCL 0,9%
16318560|NCT00510159|Drug|Artesunate+Sulfamethoxypyrazine/pyrimethamin|
16318561|NCT00510159|Drug|Praziquantel|
16318562|NCT00510146|Drug|Olanzapine|5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).
16318563|NCT00510146|Drug|Placebo|placebo tablets, oral, once daily at bedtime, 6 weeks
16318564|NCT00510133|Biological|GRNVAC1|Autologous dendritic cell vaccine
16318565|NCT00510120|Behavioral|Parent management training (PMT)|PMT primarily involves teaching parents strategies to respond consistently and correctly to their child's behavior. Parents assigned to the PMT group will be taught how to respond consistently and appropriately to their child's positive and negative behaviors. Participants will attend a 1-hour treatment session each week for 10 weeks.
16318566|NCT00510120|Behavioral|Collaborative problem solving (CPS)|CPS is a treatment approach that involves both the parent and child by teaching parents to help their child control their emotions and to problem solve as a family. Parents assigned to the CPS group will be taught strategies to help their child identify and regulate emotions and to solve behavior problems together as a family. Participants will attend a 1-hour treatment session each week for 10 weeks.
16318567|NCT00510120|Behavioral|Waitlist control|Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.
16318568|NCT00510107|Drug|oxaliplatin|oxaliplatin 120 mg/m2 will be given on day 1.
16318569|NCT00510107|Drug|Cisplatin|Cisplatin 60 mg/m2 will be given on day 1.
16318570|NCT00510094|Behavioral|Friend to Friend program|Friend to Friend arm is a social information processing group treatment to help aggressive girls learn better social problem solving and decision making choices. Participants will learn how to identify signs of physiological arousal, evaluate others' intentions, react to a potential conflict situation, and generate and evaluate alternatives. Treatment sessions are twice per week (30 to 40 minutes per session) for ten weeks.
16318571|NCT00510094|Behavioral|Psychoeducational attention control intervention|Psychoeducational attention control group also meets two times per week for 10 weeks to control for nonspecific factors of treatment. Participants learn homework, study skills, and organizational skills.
16318572|NCT00510081|Device|Calcium Hydroxylapatite injection|filler injection
16318573|NCT00510068|Drug|Everolimus|A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.
16318574|NCT00510068|Drug|Everolimus Placebo|a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.
16318575|NCT00510055|Procedure|subdermal manipulation ONLY|scars receive subdermal manipulation ONLY
16318576|NCT00510055|Procedure|subdermal manipulation AND injection of a filler|scars receive subdermal manipulation AND injection of a filler
16318577|NCT00510029|Drug|GAP-134|atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO
16318578|NCT00510016|Drug|Clonidine HCL|Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
16318579|NCT00510003|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16318580|NCT00509990|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16318581|NCT00509977|Procedure|Light Treatment|Light treatment applied to half of the face at each study visit
16318582|NCT00509977|Procedure|Laser Treatment|Laser treatment applied to half of the face at each study visit
16318583|NCT00509964|Drug|irinotecan|Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
16318584|NCT00509964|Drug|ILF|Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.
16318632|NCT00509626|Procedure|psychosocial assessment and care|
16318633|NCT00509626|Procedure|quality-of-life assessment|
16318634|NCT00509613|Drug|Sorafenib|
16318635|NCT00509613|Drug|Sirolimus|
16318585|NCT00509951|Behavioral|One-session exposure treatment|Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner.
16318586|NCT00509951|Behavioral|Augmented one-session exposure treatment|Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session.
16318587|NCT00509938|Drug|human lactoferrin peptide 1-11|Each subject will receive a single intravenous dose of hLF1-11 given in a volume of 20mL given over 20 minutes i.e. 1mL/per minute.
16318588|NCT00509925|Drug|insulin detemir|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
16318589|NCT00509925|Drug|insulin NPH|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
16318590|NCT00509925|Drug|insulin aspart|Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
16318591|NCT00509899|Drug|Ruxolitinib|5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.
16318592|NCT00509886|Drug|Drysol|20% aluminum chloride hexahydrate
16318593|NCT00509886|Drug|Drioff|1% aluminum acetate
16318594|NCT00509873|Drug|Gatifloxacin 0.5% eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
16318595|NCT00509873|Drug|placebo eye drops|Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
16318596|NCT00509860|Drug|Irinotecan|16 mg/m2 by vein Daily Over 1 Hour x 5 Days
16318597|NCT00509847|Drug|human lactoferrin peptide 1-11|(A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10
16318598|NCT00509834|Drug|hLF1-11|"The study treatment consists of IV administration of:
~(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10"
16318599|NCT00509834|Drug|hLF1-11|0.5mg hLF1-11 iv per day for 14 consecutive days
16318600|NCT00509834|Drug|Placebo|Placebo
16318601|NCT00509821|Drug|Enzastaurin 500 milligram (mg) Once Daily (QD)|1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment.
16318602|NCT00509821|Drug|Enzastaurin 250 mg Twice Daily (BID)|1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment.
16318603|NCT00509808|Device|Electrostimulation|"1st month GN wearing (activated or sham mode)
~2nd month wearing (opposite mode)
~3rd - 5th month: activated GN wearing for 1, 5 or 10 minutes
~6th - 8th month: activated GN wearing for 1, 5 or 10 minutes
~9th - 11th month: activated GN wearing for 1, 5 or 10 minutes"
16318604|NCT00509795|Biological|ranibizumab|Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16318605|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16318606|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16318607|NCT00509795|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
16318608|NCT00509782|Drug|ZIO-101|Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks.
16318609|NCT00509769|Drug|Trastuzumab emtansine [Kadcyla]|Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
16318610|NCT00509756|Drug|FXR-450|capsule, single oral doses from 10 mg to 450 mg
16318611|NCT00509756|Drug|Placebo|capsule similar to active drug
16318612|NCT00509743|Drug|Intravenous diclofenac sodium (DIC075V)|High dose Diclofenac
16318613|NCT00509743|Drug|Intravenous diclofenac sodium (DIC075V)|Low Dose Diclofenac
16318614|NCT00509730|Procedure|Urodynamics|
16318615|NCT00509717|Other|intensive implementation programme|educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.
16318616|NCT00509717|Other|control|educational manual
16318617|NCT00509691|Biological|cytomegalovirus pp65-specific cytotoxic T lymphocytes|
16318618|NCT00509691|Genetic|polymerase chain reaction|
16318619|NCT00509691|Other|diagnostic laboratory biomarker analysis|
16318620|NCT00509691|Other|flow cytometry|
16318621|NCT00509691|Other|immunologic technique|
16318622|NCT00509678|Drug|Rituximab|1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
16318623|NCT00509665|Drug|doxorubicin hydrochloride|given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.
16318624|NCT00509665|Drug|gemcitabine hydrochloride|given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
16318625|NCT00509652|Procedure|Arm 1: Erythrocyte apheresis|Erythrocyte apheresis
16318626|NCT00509652|Procedure|Arm 2: Whole blood phlebotomy|Traditional whole blood phlebotomy
16318627|NCT00509639|Drug|10% Metronidazole Ointment|Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
16318628|NCT00509626|Behavioral|exercise intervention|
16318636|NCT00509600|Drug|Etanercept|0.8 mg/kg Subcutaneously Once A Week for 90 Days
16318637|NCT00509587|Drug|pazopanib hydrochloride|Given orally
16318638|NCT00509587|Procedure|pharmacological study|Correlative studies
16318639|NCT00509587|Procedure|laboratory biomarker analysis|Correlative studies
16318640|NCT00509561|Biological|cetuximab|
16318641|NCT00509561|Drug|capecitabine|
16318642|NCT00509561|Drug|cisplatin|
16318643|NCT00509561|Radiation|radiation therapy|
16318644|NCT00509548|Drug|TG100801|Eye drop, twice a day, 30 days.
16318645|NCT00509535|Drug|vitreoscilla filiformis cream|
16318646|NCT00509496|Drug|fludarabine phosphate|25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days.
16318647|NCT00509496|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenous
16318648|NCT00509496|Biological|aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16318649|NCT00509496|Biological|autologous anti-gp 100:154-162 T-cell receptor gene-engineered tumor infiltrating lymphocytes|"Patients will receive a minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL .
~The cells are infused intravenously over 20-30 minutes."
16318650|NCT00509496|Biological|autologous anti-gp 100:154-162 T-cell receptor gene-engineered peripheral blood lymphocytes|"Patients will receive a minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered PBL.
~The cells are infused intravenously over 20-30 minutes."
16318651|NCT00509483|Radiation|Radioactive iodine|Radioactive iodine preceded by rhTSH
16318652|NCT00509470|Drug|telmisartan plus hydrochlorothiazide|Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day
16318653|NCT00509470|Device|Amlodipine|
16318654|NCT00509457|Biological|GV 1001 Telomerase peptide|
16318655|NCT00509444|Behavioral|Educational materials|
16318656|NCT00509444|Behavioral|educational materials, plus patient navigation|
16318657|NCT00509431|Drug|Erlotinib + Sirolimus|In arm I of dose escalation phase,starting dose of erlotinib is 150 mg daily. Starting dose of sirolimus includes a 15 mg loading dose, followed by continuous dosing at 5 mg daily.Dose escalation will proceed according to protocol Phase II of the study was not conducted only Phase I
16318658|NCT00509418|Dietary Supplement|Viusid|Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
16318659|NCT00509418|Other|Hypocaloric Diet with controlled exercise|Modified ADA diet in combination with controlled exercise daily 24 weeks
16318660|NCT00509405|Drug|potassium citrate|6 times 10 mEq per day, oral for 24 months
16318661|NCT00509392|Device|Seg. RF Ablation & ClosureFAST catheter|Seg. RF Ablation & ClosureFAST catheter
16318662|NCT00509392|Device|Endovenous Laser|laser catheter
16318663|NCT00509379|Drug|Rituximab|Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
16318664|NCT00509379|Drug|VELCADE|VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
16318665|NCT00509366|Drug|Cisplatin & Gemcitabine|"Squamous Cell NSCLC:
~Gemcitabine 1250 mg/m2 IV over 30 minutes day 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes day 1; repeat every 21 days for up to 6 cycles"
16318666|NCT00509366|Drug|Cisplatin & Pemetrexed|"Non-Squamous Cell NSCLC:
~Pemetrexed 500 mg/m2 IV over approximately 10 minutes day 1, followed by Cisplatin 75 mg/m2 IV over 60 minutes day 1; repeat every 21 days for up to 6 cycles"
16318667|NCT00509366|Drug|Docetaxel & Gemcitabine|"Squamous Cell NSCLC:
~Docetaxel 75 mg/m2 IV over 60 minutes day 1, followed by Gemcitabine 1250 mg/m2 IV over 30-60 minutes day 1 and alone day 8; repeat every 21 days for up to 6 cycles"
16318668|NCT00509366|Drug|Pemetrexed & Gemcitabine|"Non-Squamous Cell NSCLC:
~Pemetrexed 500 mg/m2 IV over approximately 10 minutes day 1, followed by Gemcitabine 1250 mg/m2 IV over 30-60 minutes day 1 and alone day 8; repeat every 21 days for up to 6 cycles"
16318669|NCT00509353|Drug|irinotecan hydrochloride|
16318670|NCT00509353|Drug|vincristine sulfate|
16318671|NCT00509353|Radiation|iobenguane I 131|
16318672|NCT00509340|Behavioral|Cognitive behavioral therapy (CBT)|Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
16318673|NCT00509327|Drug|bisacodyl|10mg capsule twice daily from one day preoperatively to day three postoperatively
16318674|NCT00509327|Drug|glucosemonohydricum|10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
16318675|NCT00509314|Behavioral|melanocyte self-assembly and functional analysis|
16318676|NCT00509301|Drug|131-I-chTNT-1/B MAB|The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.
16318677|NCT00509288|Biological|autologous anti-MART-1 F5 T-cell receptor|"Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes.
~A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL."
16318678|NCT00509288|Drug|Cyclophosphamide|Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
16318679|NCT00509288|Drug|Fludarabine|Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days
16318680|NCT00509288|Biological|Aldesleukin|Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion
16318681|NCT00509288|Biological|autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes|
16318682|NCT00509275|Drug|W0027|capsule
16318683|NCT00509275|Drug|Placebo|Placebo
16318684|NCT00509262|Drug|Sitagliptin|Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
16318685|NCT00509262|Drug|Glipizide|Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
16318686|NCT00509262|Drug|Placebo for Sitagliptin|Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
16318687|NCT00509262|Drug|Placebo for Glipizide|Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
16318688|NCT00509249|Biological|ziv-aflibercept|Given IV
16318689|NCT00509249|Other|laboratory biomarker analysis|Correlative studies
16318690|NCT00509249|Other|pharmacological study|Correlative studies
16318691|NCT00509236|Drug|Sitagliptin|25 mg (one 25-mg tablet) once daily
16318692|NCT00509236|Drug|Glipizide|2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg
16318693|NCT00509223|Device|Positive Airway Pressure therapy|Positive Airway Pressure (PAP) therapy initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.
16318694|NCT00509223|Behavioral|Lifestyle counseling|Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
16318695|NCT00509210|Drug|telaprevir (VX-950)|
16318696|NCT00509197|Drug|Placebo (sham inhaler)|
16318697|NCT00509197|Drug|Fluticasone|Fluticasone 250mcg bid for one month
16318698|NCT00509184|Drug|Rituximab|375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap
16318699|NCT00509171|Device|Reamer Irrigator Aspirator|Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
16318700|NCT00509158|Biological|arm I: PfLSA-3-rec with aluminium hydroxide as adjuvant|
16318701|NCT00509158|Biological|arm 2: PfLSA-3-rec with Montanide Isa 720 as adjuvant|
16318702|NCT00509145|Drug|Laquinimod|Laquinimod 0.6 mg capsule, oral, once daily
16318703|NCT00509145|Other|Placebo|oral, once daily, capsule
16318704|NCT00509132|Drug|trodusquemine|
16318705|NCT00509106|Drug|Ceftaroline fosamil for Injection|2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
16318706|NCT00509106|Drug|Ceftriaxone|1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
16318707|NCT00509106|Drug|Placebo|Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
16318708|NCT00509093|Drug|imatinib mesylate|Patients will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. The study dose can be split but the dose of 600 mg must be given within a 12 hour period.
16318709|NCT00509093|Genetic|gene expression analysis|Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
16318710|NCT00509093|Genetic|mutation analysis|FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
16318711|NCT00509093|Genetic|polymerase chain reaction|AF1q gene analysis (on bone marrow aspirate)
16318712|NCT00509093|Other|flow cytometry|C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated as the c-kit mean channel number (MCN) of the blasts/ MCN auto fluorescence.
16318713|NCT00509093|Procedure|biopsy|Diagnostic bone marrow biopsy/aspirate must be done within 3 weeks of registration documenting complete remission
16318714|NCT00509067|Drug|Galantamine|Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.
16318715|NCT00509067|Drug|CDP-choline|CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.
16318716|NCT00509067|Drug|Placebo|The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.
16318717|NCT00509067|Drug|risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole|All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.
16318718|NCT00509054|Procedure|Prophylactic mesh|A low weigth partly absorbable mesh in a subaly posistion
16318719|NCT00509041|Drug|dasatinib|50 mg PO bid
16318720|NCT00509028|Drug|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
16318721|NCT00509028|Drug|Conventional Asthma Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
16318722|NCT00509015|Drug|Sulphadoxine-pyrimethamine (day 1: 500mg S&25mg P/20 kg)|500mg S&25mg P/20 kg, 1 day, single dose
16318723|NCT00509015|Drug|Artesunate (day 1,2,3: 4 mg/kg)|4 mg/kg, daily single dose over three days
16318724|NCT00509015|Drug|Primaquine-base (day 3: 0.75 mg/kg)|single dose at 0.75 mg/kg on day 3
16318725|NCT00509015|Drug|placebo tablets|3 days of lactose tablets (160mg) albochin
16318726|NCT00509002|Drug|Gefitinib|250 mg by mouth once a day, every day, at about same time in morning.
16318727|NCT00508989|Drug|Niacin-ER|500 mg daily for 4 weeks, 1000 mg daily for 4 weeks, and 1500 mg daily for 4 weeks
16318728|NCT00508989|Drug|Placebo|500 mg daily for 4 weeks, 1000 mg daily for 4 weeks, and 1500 mg daily for 4 weeks
16318729|NCT00508989|Drug|L-NMMA|
16318730|NCT00508989|Drug|Acetylcholine|
16318731|NCT00508976|Drug|Injected bupivacaine post-operatively|Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
16318732|NCT00508976|Drug|Streamed bupivacaine versus streamed normal saline|Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
16318733|NCT00508976|Drug|Aerosolized bupivacaine versus aerosolized saline|Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
16318734|NCT00508976|Drug|Injected lidocaine pre-incision vs saline pre-incision|Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
16318735|NCT00508963|Drug|sodium stibogluconate (Pentostam)|20 mg/kg IV every day for 20 or 28 days
16318736|NCT00508950|Procedure|Large volume blood draw|Large volume blood draw
16318737|NCT00508937|Other|Diet|15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)
16318738|NCT00508937|Other|Diet|20% protein, 35% carbohydrate, 45% fat (7% saturated, 7% polyunsaturated)
16318739|NCT00508937|Other|Diet|20% protein, 35% carbohydrate, 45% fat (15% saturated, 7% polyunsaturated)
16318740|NCT00508937|Other|Diet|30% protein, 35% carbohydrate, 35% fat (7% saturated, 7% polyunsaturated)
16318741|NCT00508937|Other|Diet|30% protein, 35% carbohydrate, 35% fat (15% saturated, 7% polyunsaturated)
16318742|NCT00508924|Drug|Argatroban|
16318743|NCT00508924|Drug|Argatroban|
16318744|NCT00508924|Drug|Argatroban|
16318745|NCT00508924|Drug|Heparin|
16318746|NCT00508911|Drug|GW876008|GW876008 tablets will be available as white to off-white coated tablets. Each subject will receive a single oral dose of GW876008, daily for up to 35 days in Session 2. GW876008 will be administered in the morning with a light breakfast.
16318747|NCT00508911|Drug|COC|COC containing ethinylestradiol 30 microgram and levonorgestrel 150 microgram will be administered in the morning with a light breakfast.
16318748|NCT00508898|Drug|Calcitriol|Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
16318749|NCT00508898|Drug|Multivitamin|Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
16318750|NCT00508885|Drug|Niacinamide|Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
16318751|NCT00508885|Drug|Placebo|Placebo
16318752|NCT00508872|Drug|5-Fluorouracil|400 mg/m^2 IV over 15 minutes, followed by 2400 mg/m^2 IV Over 46 Hours
16318753|NCT00508872|Drug|Bevacizumab|5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
16318754|NCT00508872|Drug|Leucovorin|400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
16318755|NCT00508872|Drug|Oxaliplatin|85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
16318756|NCT00508859|Drug|Sertraline|maintenance treatment with sertraline
16318757|NCT00508859|Drug|placebo|placebo
16318758|NCT00508846|Behavioral|Questionnaire|Two-part telephone questionnaire lasting about 60 minutes total.
16318759|NCT00508833|Biological|287615 containing HBsAg with adjuvants|
16318760|NCT00508820|Biological|Romiplostim|Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
16318761|NCT00508807|Drug|RTA 402|5 mg by mouth (PO) daily for 21 days
16318762|NCT00508794|Behavioral|Yoga Group|3 sessions of yoga each week for 6 weeks.
16318763|NCT00508794|Behavioral|Stretching Control Group|3 sessions of stretching each week for 6 weeks
16318764|NCT00508794|Behavioral|Waitlist Control Group|Option of participating in the yoga or stretching program after the study has ended.
16318765|NCT00508794|Other|Questionnaire|Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
16318766|NCT00508781|Behavioral|Multiphoton laser image in cutaneous pathology|
16318767|NCT00508768|Drug|Oral SCIO-469 capsule|
16318768|NCT00508755|Device|Gait Robot|gait training with the use of a gait robot
16318769|NCT00508755|Device|Functional Neuromuscular stimulation with intramuscular electrodes|gait training with use of functional electrical stimulation
16318770|NCT00508742|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 2, 4, 6 and 12 months of age
16318771|NCT00508742|Biological|7 valent pneumococcal conjugate vaccine|1 dose at 2, 4, 6 and 12 months of age
16318772|NCT00508729|Drug|Qingyi granules|
16318773|NCT00508716|Behavioral|Health Literacy-Tailored Education|Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
16318774|NCT00508703|Radiation|Intensity Modulated Radiotherapy (IMRT)|Dose of 45Gy
16318775|NCT00508703|Procedure|CT Scan|CT Scans: Twice a week during the 5 weeks of radiation treatment.
16318776|NCT00508690|Drug|cefmetazole|Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
16318822|NCT00508365|Drug|Placebo|Placebo capsules to match each dose level will be provided.
16318777|NCT00508690|Drug|kanamycin/metronidazole|2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
16318778|NCT00508664|Radiation|Radiation|Radiation start in week 11
16318779|NCT00508664|Drug|Cetuximab|Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
16318780|NCT00508664|Drug|Docetaxel|75 mg/m2 i.v. day 1 3 times
16318781|NCT00508664|Drug|Cisplatin (TP)|75 mg/m2 i.v. day 1 3 times
16318782|NCT00508664|Drug|5-Fluorouracil (TPF) (only until Feb 2009)|Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
16318783|NCT00508651|Biological|MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
16318784|NCT00508651|Biological|Placebo|Placebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
16318785|NCT00508625|Drug|AMG 951 (rhApo2L/TRAIL)|AMG 951 is recombinant human Apo2Ligand/Tumor necrosis factor related apoptosis inducing ligand (rhApo2L/TRAIL) that triggers apoptosis through activation of death receptor 4 (DR4) and death receptor 5 (DR5).
16318786|NCT00508625|Drug|Bevacizumab|Bevacizumab is a recombinant humanized version of a murine antibody to vascular endothelial growth factor (VEGF).
16318787|NCT00508625|Drug|Carboplatin|Standard platinum based chemotherapy
16318788|NCT00508625|Drug|Paclitaxel|Standard taxane chemotherapy
16318789|NCT00508612|Behavioral|Williams LifeSkills Stress and Anger Management Workshop|Williams LifeSkills Stress and Anger Management Workshop
16318790|NCT00508612|Behavioral|High school classes|The control group will attend regular high school classes.
16318791|NCT00508599|Other|Study 2 (48 hours of complete bed rest)|Effects of 48 hours of bed rest on insulin resistance in type 2 diabetic subjects.
16318792|NCT00508586|Drug|PTC299|PTC299 orally administered twice per day given in combination with anastrozole (Arimidex®), letrazole (Femara®), or exemestane (Aromasin®)
16318793|NCT00508573|Behavioral|Questionnaire|Follow-up questionnaire done once a year for five years.
16318794|NCT00508560|Behavioral|Contingency Management|"Participants draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Tokens include messages of encouragement (Good job!) or VA canteen vouchers of varying monetary value."
16318795|NCT00508560|Behavioral|Reward|Participants receive set reward (VA canteen voucher) for each week of smoking cessation treatment they attend. The value of the reward will not change regardless of attendance at consecutive sessions.
16318796|NCT00508534|Drug|SB-751689|
16318797|NCT00508521|Device|Functional Electrical Stimulation|commercially available surface electrical stimulator
16318798|NCT00508521|Other|Standard Care|Standard care as ordered by their physician and covered by their insurance company.
16318799|NCT00508508|Behavioral|Interactive Voice Response System|Participants using IVR will receive training in peer communication techniques and participate in an initial nurse-led interactive group visit. They will then be asked to communicate at least weekly with their partner using the IVR system. The IVR system will also automatically send reminder calls to participants and allow them to leave voice mail messages for their partner and their care manager.
16318800|NCT00508508|Behavioral|Nurse-Led Group Clinic Visits|At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.
16318801|NCT00508495|Drug|Paracetamol (acetaminophen)|Four 100 mL, 15 min IV infusions at six hour intervals
16318802|NCT00508495|Drug|Paracetamol 1% solution|Four 100 mL, 15 min IV infusions at six hour intervals
16318803|NCT00508495|Drug|0.9% sodium chloride solution|Four 100 mL, 15 min IV infusions at six hour intervals
16318804|NCT00508482|Other|deep needling|"Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain.
~Once a day, five times a week, four weeks."
16318805|NCT00508482|Drug|Lactulose|20-30ml, once a day before breakfast, for the whole study except the run-in period
16318806|NCT00508482|Other|shallow needling|Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
16318807|NCT00508469|Drug|Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
16318808|NCT00508469|Drug|Travoprost 0.004% eye drops|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
16318809|NCT00508469|Drug|Timolol 0.05% eye drops|One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
16318810|NCT00508469|Device|Travalert Dosing Aid|Approved device used with study medication to record time of instillation and quantify dosing
16318811|NCT00508456|Drug|Temodar (Temozolomide)|150 mg/m^2 orally once a day for 7 consecutive days (days 8 through 15).
16318812|NCT00508456|Dietary Supplement|Hominex-2|"Methionine free diet during Days 1 - 7 and Days 15 - 21 by consuming only shakes containing Hominex-2®."
16318813|NCT00508443|Radiation|Radiation Therapy|Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
16318814|NCT00508430|Drug|ASP8825|oral
16318815|NCT00508430|Drug|Placebo|oral
16318816|NCT00508404|Drug|Panitumumab|Administered by intravenous infusion
16318817|NCT00508404|Drug|FOLFIRI|FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².
16318818|NCT00508391|Device|Optimized interventricular delay biventricular pacing|Lumax HF-T with optimized interventricular delay biventricular pacing
16318819|NCT00508378|Behavioral|Interview|Interview regarding side-effects of chemotherapy, 30-45 minutes.
16318820|NCT00508378|Behavioral|Questionnaire|Quality of life survey and symptom assessment questionnaire, 15 minutes.
16318821|NCT00508365|Drug|Carvedilol CR capsules|The carvedilol micropump (COREG) CR cpsules will be available with doses of 20 milligrams and 40 milligrams administered orally once daily.
16318823|NCT00508365|Drug|Lisinopril|Lisinopril will be available as 10 milligrams tablets administered orally once daily.
16318824|NCT00508352|Procedure|Helical tomotherapy IMRT|Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
16318825|NCT00508339|Behavioral|Questionnaire|Toronto Extremity Salvage Score (TESS) questionnaire.
16318826|NCT00508326|Drug|Paclitaxel|Starting dose 150 mg/m^2 HAI once every 4 weeks
16318827|NCT00508313|Procedure|Thermal Imaging|Thermal imaging sessions, each taking approximately 10 minutes.
16318828|NCT00508300|Procedure|Epidural analgesia|Thoracic epidural analgesia until day 2
16318829|NCT00508300|Procedure|Patient controlled analgesia|Patient controlled analgesia (morphine-based)
16318830|NCT00508287|Drug|BMS-686117|Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
16318831|NCT00508287|Drug|Byetta|Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
16318832|NCT00508287|Drug|Placebo|Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
16318833|NCT00508274|Drug|lapatinib|Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally.
16318834|NCT00508274|Drug|capecitabine|Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.
16318835|NCT00508261|Biological|Meningococcal vaccine GSK134612|Single dose intramuscular injection
16318836|NCT00508261|Biological|Infanrix™ hexa|Single dose intramuscular injection
16318837|NCT00508261|Biological|Meningitec™|Single dose intramuscular injection
16318838|NCT00508248|Dietary Supplement|omega 3 fatty acids|1g daily
16318839|NCT00508248|Dietary Supplement|placebo|olive oil capsule
16318840|NCT00508235|Behavioral|Questionnaire|Questionnaire about the patient's relationship with their best friend.
16318841|NCT00508222|Drug|Kaletra Tablets|Kaletra 800/200 OD
16318842|NCT00508209|Drug|bortezomib|1.3 mg/sqm days -5 and -2 in connection with high-dose melphalan (200mg/sqm day -2) and autologous stem cell support
16318843|NCT00508196|Other|RVP-min|DDD pacing with long AV delay
16318844|NCT00508196|Other|RVP-max|DDD pacing with short AV delay
16318845|NCT00508183|Procedure|single row|This method involves using a single row of anchor(s) to reattach the cuff to the bone.
16318846|NCT00508183|Procedure|double row fixation|"This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
16318847|NCT00508170|Behavioral|Questionnaire|The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete.
16318848|NCT00508157|Drug|Aripiprazole|Tablets, Oral, 5 to 30 mg, once daily, 16 weeks
16318849|NCT00508157|Drug|Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)|Tablets, Oral, According to summary of product characteristics (SmPC)
16318850|NCT00508144|Drug|Alimta|500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks
16318851|NCT00508131|Other|Whole Cows Milk|400 mL, administered as two 200 mL drinking episodes per day of either fortified or not fortified milk for 12 months.
16318852|NCT00508118|Drug|Nicardipine|on bypass
16318853|NCT00508118|Drug|0.9% saline|on bypass
16318854|NCT00508105|Procedure|subscapularis peel|"Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel."
16318855|NCT00508105|Procedure|osteotomy|This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
16318856|NCT00508092|Procedure|local anesthetic administration|"Pre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight
~OR
~Pre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight"
16318857|NCT00508066|Drug|Bupivacaine|Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
16318858|NCT00508066|Drug|Normal Saline|Normal Saline, 4ml/hour for 72 hours.
16318859|NCT00508053|Procedure|Small stitches|
16318860|NCT00508053|Procedure|Mass closure|
16318861|NCT00508040|Drug|interferon alpha 2a|We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
16318862|NCT00508040|Drug|prednisone|We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not expose to a worsening of the disease because of the slow pathologic processus.
16318863|NCT00508027|Drug|Simvastatin|Comparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.
16318864|NCT00508014|Other|Usual Care|Usual Care with primary care provider during time period
16318865|NCT00508014|Behavioral|Concurrent Peer Review visit|Participants are offered an office visit with a peer of their clinician primary clinician. This office visit is structured and focused on blood pressure, diabetic, and/or lipid control with decision support available at point of care
16318866|NCT00508001|Drug|Vandetanib|ZD6474 300mg
16318867|NCT00508001|Drug|Vandetanib|ZD6474 100 mg
16318868|NCT00508001|Drug|Best Supportive Care|Placebo + Best Supportive Care
16318869|NCT00507988|Behavioral|Complex Problem Solving Training|10 sessions of 45 minutes complex problem solving training over 3 weeks (including 30 minutes of computerized planning and problem-solving training with Plan-A-Day and 15 minutes group session for transfer to everyday situations)
16318870|NCT00507988|Behavioral|Basic Cognitive Training|10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
16318871|NCT00507975|Drug|nicotine versus placebo|The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
16318872|NCT00507962|Drug|Cisplatin|100 mg/m^2 Intraarterial On Day 1 Every 4 Weeks
16318873|NCT00507962|Drug|Liposomal Doxorubicin|Starting dose 20 mg/m^2 IV On Day 1 Every 4 Weeks
16318874|NCT00507949|Drug|Megestrol acetate|Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
16318875|NCT00507949|Drug|placebo|sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
16318876|NCT00507936|Drug|ABT-894|ABT-894 1 mg capsule BID throughout treatment period
16318877|NCT00507936|Drug|ABT-894|ABT-894 2 mg capsule BID throughout treatment period
16318878|NCT00507936|Drug|ABT-894|ABT-894 4 mg capsule BID throughout treatment period
16318879|NCT00507936|Drug|placebo|placebo capsule BID throughout the treatment period
16318880|NCT00507936|Drug|Duloxetine|Duloxetine 60 mg QD throughout treatment period
16318881|NCT00507923|Device|Actigraph|Wear actigraph
16318882|NCT00507923|Other|Best Practice|Receive usual care
16318883|NCT00507923|Other|Quality-of-Life Assessment|Ancillary studies
16318884|NCT00507923|Other|Questionnaire Administration|Ancillary studies
16318885|NCT00507923|Other|Sleep Diary|Complete sleep diary
16318886|NCT00507923|Other|Stretching|Participate in stretching sessions
16318887|NCT00507923|Procedure|Yoga|Participate in Tibetan yoga
16318888|NCT00507884|Procedure|3 Tesla MRI Scan|MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours.
16318889|NCT00507858|Drug|Pemetrexed|Starting dose of 500 mg/m^2 IV Once Over 10 Minutes Every 3 Weeks
16318890|NCT00507858|Drug|Dexamethasone|Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days
16318891|NCT00507845|Drug|Ramipril-Felodipine|Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).
16318892|NCT00507832|Drug|Pimecrolimus|twice daily topical
16318893|NCT00507832|Drug|Hydrocortisone|twice daily topical
16318894|NCT00507832|Drug|Pimecrolimus|topical application as a cream twice daily
16318895|NCT00507819|Drug|Sildenafil|One 20 mg capsule of sildenafil will be taken by mouth three times-a-day.
16318896|NCT00507819|Drug|Placebo|One placebo capsule will be taken by mouth three times-a-day.
16318897|NCT00507806|Drug|perflutren lipid microsphere|
16318898|NCT00507793|Drug|Sirolimus|
16318899|NCT00507793|Drug|Cyclosporine|
16318900|NCT00507780|Drug|GnRH antagonist|
16318901|NCT00507767|Drug|dasatinib|Given PO or via PEG tube
16318902|NCT00507767|Procedure|pharmacological study|Correlative studies
16318903|NCT00507767|Procedure|laboratory biomarker analysis|Correlative studies
16318904|NCT00507754|Other|T-SPOT TB test|Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.
16318905|NCT00507741|Drug|Vintafolide|Part A: Induction Phase: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance Phase: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting. Part B: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.
16318906|NCT00507741|Drug|Ertafolide|
16318907|NCT00507728|Drug|Bupropion|Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
16318908|NCT00507728|Drug|Varenicline|Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
16318909|NCT00507728|Drug|Placebo|Placebo by mouth for 12 weeks.
16318910|NCT00507728|Behavioral|Smoking Cessation Counseling|Counseling over 8 months and telephone support calls.
16318911|NCT00507715|Drug|Plantago ovata husk|5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
16318912|NCT00507715|Other|hemicellulose crystalline|5g effervescent powder t.id. during 14 days
16318913|NCT00507702|Procedure|phlebotomy|Standard of care
16318914|NCT00507689|Drug|FTC/TDF|Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.
16318915|NCT00507689|Drug|Hepatitis B Immunoglobulin (HBIg)|HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.
16318916|NCT00507663|Drug|Atenolol|Patients with a standing prescription for β-blockers will be continued on that medication. Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7.
16318917|NCT00507650|Dietary Supplement|Fluid intervention|Volume of fluid prescribed by physician or provider/day X 5 days.
16318918|NCT00507650|Dietary Supplement|Fluid intervention plus 10 ml/kg/day|Fluid volume and type prescribed by physician or provider plus 10 ml/kg/day X 5 days.
16318919|NCT00507637|Drug|NT 201|Injection of up to 50 Units NT 201 (incobotulinumtoxinA/Xeomin®) per eye and injection visit (8 injections visits in total).
16318920|NCT00507611|Procedure|Sentinel node mapping|Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization. Intraoperatively, patients will also be injected with approximately 4 to 5 mL of 1% isosulfan blue dye (by intradermal, intraparenchymal, or subareolar route). Patients will undergo intraoperative identification and biopsy of all SLN candidates. A confirmatory axillary lymph node dissection will then be performed on all patients.
16318921|NCT00507598|Other|No intervention|Correlative study collecting serum and tissue samples
16318922|NCT00507585|Drug|Fluorouracil|300 mg/m^2 IV over 10 Minutes, then 600 mg/m^2 IV over 22 Hours repeated every 3 weeks (1 Cycle).
16318923|NCT00507585|Drug|Avastin|10 mg/m^2 IV Over 90 Minutes repeated every 3 weeks (1 Cycle).
16318924|NCT00507585|Drug|Leucovorin|200 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).
16318925|NCT00507585|Drug|Oxaliplatin|60 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).
16318927|NCT00507559|Device|Aptus Endovascular AAA Repair System|EVAR (endovascular aneurysm repair)
16318928|NCT00507546|Drug|Ramelteon|8 mg nightly
16318929|NCT00507546|Drug|Placebo|Nightly 8mg of placebo (same appearance as ramelteon)
16318934|NCT00507507|Drug|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily
16318935|NCT00507507|Drug|FTC|Emtricitabine (FTC) 200 mg capsule taken orally once daily
16318936|NCT00507507|Drug|Placebo|Placebo to match FTC taken once daily
16318937|NCT00507494|Drug|pioglitazone|Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.
16318938|NCT00507468|Procedure|Transendocaridal Transplantation of Autologous Bone Marrow|Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.
16318939|NCT00507455|Drug|solifenacin succinate|Solifenacin succinate tablets
16318940|NCT00507455|Drug|tamsulosin hydrochloride|Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
16318941|NCT00507455|Drug|Placebo to solifenacin|
16318942|NCT00507455|Drug|Placebo to tamsulosin|
16318943|NCT00507442|Drug|VELCADE (bortezomib)|bortezomib 1.3 mg/m^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance).
16318944|NCT00507442|Drug|dexamethasone|dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop
16318945|NCT00507442|Drug|cyclophosphamide|cyclophosphamide 500 mg/m^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop
16318946|NCT00507442|Drug|Revlimid (lenalidomide)|"lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm)
~lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)"
16318947|NCT00507429|Drug|CA4P|CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
16318948|NCT00507429|Drug|paclitaxel|200mg/m squared on Day 1
16318949|NCT00507429|Drug|carboplatin|6 AUC on Day 1 following paclitaxel
16318950|NCT00507416|Drug|Bortezomib|Bortezomib bolus intravenous (IV) injection
16318951|NCT00507416|Drug|Dexamethasone|Dexamethasone for oral administration
16318952|NCT00507416|Drug|Melphalan|Melphalan for oral administration
16318953|NCT00507416|Drug|Prednisone|Prednisone for oral administration
16318954|NCT00507416|Drug|Thalidomide|Thalidomide for oral administration
16318955|NCT00507403|Drug|infliximab|
16318956|NCT00507390|Dietary Supplement|n-3 polyunsaturated fatty acids (PUFAs)|2g n-3 PUFAs once daily for 8 weeks
16318957|NCT00507390|Dietary Supplement|olive oil|1 capsule day
16318958|NCT00507364|Drug|Local injection of activated macrophages to anal fissure|
16318959|NCT00507351|Behavioral|Questionnaire|3 questionnaires that will take 20 minutes total to complete.
16318960|NCT00507338|Procedure|PCI|early PCI for NSTEMI; primary PCI for STEMI
16318961|NCT00507325|Procedure|Blood Sample|Blood samples will be collected.
16318962|NCT00507325|Procedure|Tumor Sample|Tumor samples will be collected using a small needle, a punch knife, or a small surgery.
16318963|NCT00507312|Device|HD medical device (ViScope)|Device
16318964|NCT00507312|Device|CSIRO device|device
16318965|NCT00507299|Behavioral|Enhanced pediatric primary care|Residents received special training to address targeted psychosocial problems. Parents bringing in children (0 - 5 years) completed a screening questionnaire and gave this to their doctor. The resident briefly assessed the identified problems and helped address them. A social worker was present to assist.
16318966|NCT00507299|Behavioral|Standard pediatric primary care|Residents did not receive special training on the targeted psychosocial problems. They did not use the parent screening questionnaire, and they did not have a dedicated social worker.
16318967|NCT00507286|Drug|combination of various doses of sildenefil and alprostadil|
16318968|NCT00507273|Other|GIST Registry|Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.
16318969|NCT00507260|Behavioral|Food Record|A record of the amount and kind of food and drink you intake will be completed.
16318970|NCT00507260|Other|Nutritional Consults|Meeting with a dietician consultant regarding issues related to food intake. Participants will also receive the results from the food records.
16318971|NCT00507247|Drug|Daptomycin|6mg/kg/day IV for at least 10 days.
16318972|NCT00507234|Drug|formoterol fumarate inhalation solution|
16318973|NCT00507221|Drug|Albendazole|"Every 3 months for 24 months (enrollment 3, 6, 9, 12, 15, 18, 21, and 24 months):
~400mg/day X 3 days"
16318974|NCT00507221|Drug|Praziquantel|At enrollment and 12 months: 25mg/kg X 1
16318975|NCT00507221|Drug|Current standard of care in Kenya|Current standard of care for HIV patients in Kenya based on WHO guidelines.
16318976|NCT00507208|Device|Dynasplint Trismus System|The Dynasplint System will be used for 6 months.
16318977|NCT00507208|Other|Tongue Depressors|Tongue depressors to be used for 3 months at which time mouth opening will be measured. If there is no change then the patient will crossover to the Dynasplint Trismus System for another 3 months.
16318978|NCT00507195|Drug|Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam|
16318979|NCT00507182|Procedure|Fluorescence Spectroscopy|1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.
16318980|NCT00507169|Drug|SVT-40776|
16318981|NCT00507156|Procedure|Standard primary PCI|Acute re-opening of the occluded coronary artery
16318982|NCT00507156|Procedure|Mechanical postconditioning|Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
16318983|NCT00507143|Drug|irinotecan|
16318984|NCT00507130|Biological|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
16318985|NCT00507130|Biological|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
16318986|NCT00507130|Biological|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
16318987|NCT00507130|Other|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
16318988|NCT00507117|Drug|Lunesta|Lunesta 3mg prior to PSG
16318989|NCT00507117|Drug|Placebo control|matching placebo
16318990|NCT00507091|Drug|ZD6474 (vandetanib) 100mg|once daily oral tablet
16318995|NCT00507078|Procedure|Surgical treatment for OSA|
16318996|NCT00507065|Drug|Mixed salts of a single-entity amphetamine (ADDERALL XR)|
16318997|NCT00507065|Drug|Placebo|
16318998|NCT00507052|Drug|N-acetylcysteine|
16318999|NCT00507039|Procedure|inhalative grass-pollen provocation|Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
16319003|NCT00507013|Device|QuickClose device|
16319004|NCT00507000|Drug|Cholecalciferol|Drug: Cholecalciferol Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months Arms: A, Cholecalciferol
16319005|NCT00507000|Drug|Lactose granules|Drug: Lactose placebo Lactose placebo granules in identical sachet given weekly and two lactose tablets for first two months followed one sachet of placebo granules every month and two tablets of lactose containing placebo tablets taken daily for next four months
16319006|NCT00506987|Drug|SCH 486757|SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment
16319007|NCT00506987|Drug|Placebo Dose 1|Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment
16319008|NCT00506974|Drug|sodium oxybate|3.5 g of sodium oxybate or placebo on two of the five overnights.
16319009|NCT00506961|Drug|Rosuvastatin|10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
16319010|NCT00506961|Drug|Simvastatin|20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
16319011|NCT00506948|Drug|Mycophenolate Mofetil (MMF)|15 mg/kg by vein or by mouth every 12 hours.
16319012|NCT00506948|Drug|Thymoglobulin|1.5 mg/kg by vein daily for 4 days
16319013|NCT00506948|Drug|Sirolimus|6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
16319014|NCT00506948|Procedure|Stem Cell Transplant|Stem cell infusion on Day 0.
16319015|NCT00506935|Drug|GVG|5 grams GVG
16319016|NCT00506935|Drug|placebo|placebo
16319017|NCT00506922|Drug|Pentostatin|"Given intravenously on days +8, +15, +22 and +30 post transplant:
~Group 2 - Pentostatin 0.5 mg/m^2
~Group 3 - Pentostatin 1 mg/m^2
~Group 4 - Pentostatin 1.5 mg/m^2
~Group 5 - Pentostatin 2 mg/m^2"
16319018|NCT00506922|Drug|Tacrolimus|Given intravenously from day -2, and will be switched to oral dosing when tolerated.
16319019|NCT00506922|Drug|Methotrexate|Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.
16319020|NCT00506909|Drug|Oxytocin|20 IU BID or 40 IU BID
16319021|NCT00506909|Drug|Placebo|20 IU BID or 40 IU BID
16319022|NCT00506896|Drug|intraarticular injection|Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
16319023|NCT00506883|Drug|High Dose Colchicine (4.8 mg total dose)|At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
16319024|NCT00506883|Drug|Low Dose Colchicine (1.8mg total dose)|At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center
16319025|NCT00506883|Other|Placebo Control|At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
16319026|NCT00506870|Device|INRatio / Coaguchek XS|INR measured by patient himself using INRation or Coaguchek device. And one follow-up of INR per month, measured in laboratory.
16319027|NCT00506870|Device|Conventional follow-up of anti-coagulation|At least, one follow-up of INR per month. Measured in laboratory.
16319028|NCT00506857|Drug|Busulfan|Starting Dose 0.8 mg/kg by vein every 6 hours x 12 doses.
16319029|NCT00506857|Drug|Fludarabine|30 mg/m^2 by vein daily x 4 days.
16319030|NCT00506844|Drug|Cetuximab, Irinotecan, Capecitabine|
16319031|NCT00506831|Drug|Imatinib mesylate|100 mg orally daily increased by 100 mg/day every 2 weeks to maximum of 400 mg daily as tolerated. Treatment for 6 months total.
16319032|NCT00506818|Other|Multifactorial vascular-risk-factor-intervention|
16319033|NCT00506805|Drug|SNX-5422|dose escalated, tablets every other day; undetermined duration until disease progression
16319034|NCT00506792|Drug|QAU145|
16319035|NCT00506792|Drug|Placebo|
16319036|NCT00506779|Drug|Imatinib Mesylate|Phase I = Maximum tolerated dose (MTD) derived from dose escalation of 400, 500, 600 mg by mouth daily
16319037|NCT00506779|Drug|Paclitaxel|175 mg/m^2 by vein over 3 Hours every 21 Days
16319038|NCT00506766|Behavioral|Bladder Health Class consisting of 6 weekly group sessions|1 time
16319039|NCT00506766|Behavioral|Practice PFMT and BT|As needed for 4 years
16319040|NCT00506766|Behavioral|Clinic examination for pelvic muscle function|1/year for 4 years
16319041|NCT00506766|Behavioral|Record keeping in 3-day voiding diary|Every 6 months for 4 years
16319042|NCT00506753|Behavioral|MI/CBT|Motivational Interviewing followed by Cognitive Behavior Therapy
16319043|NCT00506753|Behavioral|RT/SU|Relaxation Training followed by Treatment as Usual
16319090|NCT00506415|Drug|Placebo to 15 cm^2 patch|Placebo of rivastigmine transdermal patch 15 cm^2.
16319044|NCT00506740|Device|Ultrasonic scalpel|A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
16319045|NCT00506740|Device|monopolar electrosurgery generator and tip|
16319046|NCT00506727|Drug|Mixed amphetamine salts (ADDERALL XR)|
16319047|NCT00506727|Drug|Atomoxetine hydrochloride|
16319048|NCT00506714|Device|single point cane|Adjustable single point cane with SureGrip handle
16319049|NCT00506701|Drug|Tadalafil|40 mg tablet
16319050|NCT00506688|Drug|reduced glutathione sodium salt|646 mg GSH-Na powder per vial to prepare a 4ml solution, twice daily for 24 weeks.
16319051|NCT00506688|Drug|0.9% normal saline (control)|4 ml of a 0.9% normal saline solution (9mg/ml NaCl), twice daily for 24 weeks.
16319052|NCT00506675|Device|Patching|42 hours per week of patching
16319053|NCT00506675|Drug|Atropine|daily atropine (1%)
16319054|NCT00506675|Device|Patching|two hours of daily patching for 4 weeks, then no treatment
16319055|NCT00506675|Drug|Atropine|once weekly atropine for 4 weeks, then no treatment
16319056|NCT00506662|Drug|insulin detemir|Treat-to-target, s.c. (under the skin) injection, once daily
16319057|NCT00506662|Drug|insulin NPH|Treat-to-target, s.c. (under the skin) injection, once daily
16319058|NCT00506649|Other|protocol|management protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium.
16319059|NCT00506636|Behavioral|Tissue engineering for hair follicle regeneration|
16319060|NCT00506623|Drug|Capecitabine, Irinotecan|
16319061|NCT00506610|Drug|T-62|
16319062|NCT00506597|Drug|Erwinase|If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.
16319063|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
16319064|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day
16319065|NCT00506584|Dietary Supplement|Human milk fortifier (bovine-based), pre-term formula|Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
16319066|NCT00506584|Dietary Supplement|Pasteurized human milk and pasteurized human milk fortifier|Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day
16319067|NCT00506584|Dietary Supplement|Pre-term/term formula|Bovine milk-derived nutrition formulated for very low birth weight infants
16319068|NCT00506571|Drug|S-1, irinotecan, oxaliplatin|
16319069|NCT00506558|Procedure|Ventral Surgical Decompression with Instrumented Fusion|Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.
16319070|NCT00506558|Procedure|Dorsal Decompression With or Without Fusion|Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion
16319071|NCT00506545|Drug|SCH 619734|SCH 619734 50-mg capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
16319072|NCT00506545|Drug|Placebo Dose 1|Matching placebo capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
16319073|NCT00506532|Drug|Surfactant (calfactant)|
16319074|NCT00506519|Drug|Antithrombin alfa (INN name)|
16319075|NCT00506519|Drug|Control (Standard treatment)|
16319076|NCT00506506|Drug|N-acetylcysteine|N-acetylcysteine 1200 mg twice daily x 48 hours
16319077|NCT00506506|Drug|Placebo|
16319078|NCT00506493|Device|Cardioblate Surgical Ablation System|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
16319079|NCT00506493|Procedure|Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
16319080|NCT00506480|Procedure|endometrial sampling|Endometrial biopsy is a procedure in which a tissue sample is obtained from the endometrium. This procedure is performed without anesthesia during pelvic examination. The cervix is cleaned with an antiseptic solution and then grasped with an instrument (tenaculum) to steady the uterus. A small, hollow plastic tube is gently passed into the uterine cavity. Gentle suction removes a sample of the lining. The tissue sample and instruments are removed, and the sample is examined by pathology, immunohistochemistry, PCR and western blotting.
16319081|NCT00506467|Procedure|Vibration Response Imaging|Lung function test performed using the VRI system immediately before or after the standard lung function test.
16319082|NCT00506454|Drug|Lipidose|Over the course of 2 weeks, immediately following subject's three (Monday/Wednesday/Friday (M/W/F)) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of Lipidose over a 2-hour period.
16319083|NCT00506454|Drug|Placebo|Over the course of 2 weeks, immediately following subject's three (M/W/F) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of placebo over a 2-hour period.
16319084|NCT00506441|Drug|MCI-196|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
16319085|NCT00506441|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
16319086|NCT00506428|Behavioral|chronic sleep restriction|5.6 hours of sleep per 24 hours for 3 weeks
16319087|NCT00506415|Drug|Rivastigmine 5 cm^2|5 cm^2 transdermal patch
16319088|NCT00506415|Drug|Rivastigmine 10 cm^2|10 cm^2 transdermal patch.
16319089|NCT00506415|Drug|Rivastigmine 15 cm^2|15 cm^2 transdermal patch.
16319091|NCT00506415|Drug|Placebo to 10 cm^2 patch|Placebo of rivastigmine transdermal patch 10 cm^2.
16319092|NCT00506402|Drug|MKC-1|Capsule, 30 mg and 100 mg, BID, continuous dosing
16319093|NCT00506389|Drug|Esmirtazapine|Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name corn starch), magnesium stearate, and lactose monohydrate.
16319094|NCT00506389|Drug|Placebo|The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.
16319095|NCT00506376|Behavioral|Interview|Interview that will take about 20 minutes to complete.
16319096|NCT00506363|Procedure|pulsed dye laser therapy|Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
16319097|NCT00506350|Biological|Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose|A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
16319098|NCT00506350|Biological|Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses|Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
16319099|NCT00506337|Drug|Qingyi granules|"Control group: The therapeutic methods accord to the concert schemes cited in the Guides to diagnosis and treatment of severe acute pancreatitis introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association.
~Treatment group: In addition to the concert schemes cited in the Guides to diagnosis and treatment of severe acute pancreatitis, during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD."
16319100|NCT00506311|Drug|Fibrin Sealant|Tisseel applied externally to the dissected groin area.
16319101|NCT00506298|Drug|bezafibrate + diflunisal|bezafibrate + diflunisal
16319102|NCT00506298|Drug|bezafibrate + placebo|bezafibrate + placebo
16319103|NCT00506285|Drug|Methylphenidate Transdermal System (MTS)|MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.
16319104|NCT00506285|Other|placebo patch|This patch is designed to appear identical to the actual intervention patch
16319105|NCT00506272|Procedure|Self blood glucose monitoring and insulin administration|Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin
16319106|NCT00506272|Procedure|Standard care|finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
16319107|NCT00506259|Drug|dTR Melatonin (NIH CC PDS)|
16319108|NCT00506259|Device|Phototherapy (Bright Light)|
16319109|NCT00506259|Drug|Melatonin CR|
16319110|NCT00506246|Drug|Propofol|"intravenous (total intravenous anaesthesia)
~induction and maintenance"
16319111|NCT00506233|Behavioral|Questionnaire|Completion of questionnaires at 3 different times (when joining this study, 3 months later, and 6 months later). Each should take about 20-30 minutes to complete.
16319112|NCT00506207|Drug|S-1, Irinotecan, Oxaliplatin|
16319113|NCT00506194|Drug|Insulin|
16319114|NCT00506194|Drug|OAD|Gliclazide-MR, Metformin, Glimepiride
16319115|NCT00506181|Drug|probiotic mixture|"Jarro-Dophilus probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day."
16319116|NCT00506181|Drug|Placebo|
16319117|NCT00506168|Drug|Irinotecan, Capecitabine|
16319118|NCT00506155|Drug|Avastin|10 mg/kg by vein over 90 minutes
16319119|NCT00506155|Drug|Cisplatin|70 mg/m^2 by vein over 4 hours
16319120|NCT00506155|Drug|Doxorubicin|30 mg/m^2 by vein over 15 minutes
16319121|NCT00506155|Drug|Methotrexate|30 mg/m^2 by vein over 30 minutes
16319122|NCT00506155|Drug|Vinblastine Sulfate|3 mg/m^2 by vein over 30 minutes
16319123|NCT00506142|Drug|Marqibo® (vincristine sulfate liposomes injection)|"Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
~Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week."
16319124|NCT00506129|Drug|Fludarabine|25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.
16319125|NCT00506129|Drug|Melphalan|70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.
16319126|NCT00506129|Procedure|Allogeneic Transplant|Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.
16319127|NCT00506129|Drug|Thymoglobulin|2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
16319128|NCT00506116|Behavioral|Videotape, routine care, PME instruction|A 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit.
16319129|NCT00506116|Behavioral|PME practice and record keeping (in diaries)|
16319130|NCT00506116|Behavioral|Non-directed or directed,spontaneous or sustained pushing|Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.
16319131|NCT00506116|Procedure|Data collection|Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum
16319132|NCT00506090|Procedure|pulsed dye laser therapy|Treatment will begin on the day of suture removal. Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.
16319133|NCT00506077|Drug|MK0249|MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
16319134|NCT00506077|Drug|Comparator: Placebo (unspecified)|MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.
16319135|NCT00506064|Drug|Melatonin|0.15 mg/kg by mouth (PO) Daily
16319136|NCT00506064|Drug|Placebo|Two, three, or four starch tablet or capsules before bed
16319137|NCT00506064|Behavioral|Questionnaire|Sleep study surveys, two per day completed each evening, lasting 10 minutes
16319138|NCT00506051|Drug|ZD6474 (vandetanib) 100mg|once daily oral tablet
16319139|NCT00506051|Drug|pemetrexed|intravenous infusion
16319140|NCT00506051|Drug|ZD6474 (vandetanib) 300mg|
16319141|NCT00506038|Procedure|fine needle technique|
16319142|NCT00506025|Dietary Supplement|Cranberry Juice|Low-calorie, Low-carbohydrate content 8 oz dose of Cranberry juice
16319143|NCT00506025|Dietary Supplement|De-Activated Cranberry juice|De-Activated Cranberry juice in the am, then placebo (P) in the pm
16319144|NCT00506012|Drug|T2000|T2000 at doses of 200 mg a day to 1000 mg a day
16319145|NCT00505999|Behavioral|Questionnaire|Questionnaire taking 30-40 minutes to complete.
16319146|NCT00505986|Procedure|endometrial biopsy|
16319147|NCT00505973|Drug|SCA-136|
16319148|NCT00505960|Behavioral|Diabetes Care for Korean Americans|Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.
16319149|NCT00505947|Drug|infliximab|infliximab 5 mg/Kg body weight by intravenous infusion
16319150|NCT00505947|Drug|placebo|placebo 5 mg/Kg body weight by intravenous infusion
16319151|NCT00505934|Drug|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days
~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
16319152|NCT00505921|Drug|Campath-1H|3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.
16319153|NCT00505921|Drug|G-CSF|10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.
16319154|NCT00505921|Drug|GM-CSF|250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.
16319155|NCT00505921|Drug|BCNU|300 mg/m2 IV over 1 hour on day -6
16319156|NCT00505921|Drug|Stem Cell Transplant|Stem cell infusion on Day 0.
16319157|NCT00505921|Drug|Preparative Regimen for Allogenic Stem Cell Transplantation|Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.
16319158|NCT00505921|Drug|Cytarabine|200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),
16319159|NCT00505921|Drug|Etoposide|200 mg/m2 IV twice on day -5 to -2 (total 8 doses)
16319160|NCT00505921|Drug|Melphalan|140 mg/m2 IV on day -1.
16319161|NCT00505921|Drug|Campath|15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation
16319162|NCT00505921|Drug|Fludarabine|30 mg/m2 IV/day (days -6 to -4)
16319163|NCT00505921|Drug|Cyclophosphamide|750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).
16319164|NCT00505921|Radiation|Low dose total body irradiation|Low dose total body irradiation of 2 Gy day 0.
16319165|NCT00505895|Drug|Melphalan|Arm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1.
16319166|NCT00505895|Drug|Fludarabine|30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
16319167|NCT00505895|Procedure|Stem Cell Infusion|Stem Cell Infusion on Day 0.
16319168|NCT00505895|Drug|Rituximab|375 mg/m^2 intravenous on Day -5, +2 +9 and +16.
16319169|NCT00505882|Drug|Pramlintide|Pramlintide will be started at 15 mcg (2.5 units) subcutaneously immediately prior to major meals and it will be increased by 15mcg every 3 days as tolerated (i.e. nausea, vomiting, upset stomach) to a maximum dose of 60 mcg (10 units) before meals. If significant nausea persists at 45 or 60 mcg level, the dose should be decreased to 30 mcg (5 units) before meals. If the 30 mcg dose is not tolerated, investigator will evaluate for possibility of withdrawing the pramlintide. The dose of preprandial short acting insulin (eg: Novolog/Humalog) will be reduced by 30 to 50% at the start of pramlintide 15 mcg (2.5 units) and then will be adjusted every time the dose of pramlintide is increased by 15 mcg (2.5 units) as needed based on blood glucose readings.
16319170|NCT00505882|Drug|Glargine|
16319171|NCT00505882|Drug|Lispro|
16319172|NCT00505882|Drug|Aspart|
16319173|NCT00505869|Behavioral|Health & Wellness Intervention|Counseling focusing on health concerns related to pregnancy, information about smoking and pregnancy, tips for quitting, and problem-solving skills to manage situations that might be triggers for smoking.
16319174|NCT00505869|Behavioral|Questionnaire|Questionnaires about mood, confidence in quitting, smoking behavior, and social support.
16319175|NCT00505869|Behavioral|Mood Management Intervention|Counseling focusing on learning to manage negative moods (depressed mood, tension, anxiety), as well as providing tips for quitting smoking, problem-solving skills, and information about smoking and pregnancy.
16319176|NCT00505843|Drug|MK0657|7mg MK0657 capsules
16319177|NCT00505843|Drug|Comparator: Placebo (unspecified)|7mg MK0657 Pbo capsules
16319178|NCT00505843|Drug|Comparator: levodopa|levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
16319179|NCT00505843|Drug|Comparator: carbidopa|carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
16319180|NCT00505830|Other|questionnaires|"Primary outcome:
~Autism Spectrum Quotient (AQ)
~Secondary outcome measure:
~Empathy quotient (EQ) Systemizing quotient (SQ) WISC III or WISC IV ADOS score ADI score"
16319181|NCT00505817|Drug|Cetrorelix and Leuprolide|
16319224|NCT00505531|Drug|Benadryl|Placebo group will take up to 25 mg of Benadryl
16319182|NCT00505804|Drug|dexmedetomidine|Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.
16319183|NCT00505804|Drug|haloperidol|Haloperidol IV loading dose of 2.5mg, followed by a continuous infusion of 0.0 to 2mg/hr for as long as deemed necessary by the treating clinician
16319184|NCT00505791|Drug|Nesiritide|Study drug will be administered for 24 hours. Study drug will be initiated with a 2-µg/kg loading bolus followed by .01-µg/kg/min infusion. This may be increased at a rate of .005-µg/kg/min. every 3 hours until maximum dose of .03-µg/kg/min. Any increase in the infusion rate will be preceded by a 1-µg/kg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure > 100 mmHg.
16319185|NCT00505778|Drug|Mesalamine Once-Daily|Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
16319186|NCT00505778|Drug|Mesalamine Twice-Daily|Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
16319187|NCT00505765|Drug|AL-108|AL-108, 5 mg/day- one spray in each nostril once per day
16319188|NCT00505765|Drug|AL-108|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
16319189|NCT00505765|Drug|Placebo|Placebo- 3 sprays in each nostril, twice per day
16319190|NCT00505765|Drug|Placebo|Placebo- one spray in each nostril, once per day
16319191|NCT00505752|Drug|AS900672-Enriched 50 microgram (mcg)|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
16319192|NCT00505752|Drug|AS900672-Enriched 100 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
16319193|NCT00505752|Drug|AS900672-Enriched 150 mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.
16319194|NCT00505752|Drug|Follitropin alfa 150 international unit (IU)|Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.
16319195|NCT00505752|Drug|Recombinant human chorionic gonadotropin (r-hCG)|Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels will approximately 150 picogram per milliliter [pg/mL] per mature follicle).
16319196|NCT00505739|Drug|Mifepristone|200 mg by mouth (PO) Daily x 4 Weeks
16319197|NCT00505726|Procedure|Reflectance Confocal Imaging|Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
16319198|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu two times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity
16319199|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319200|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 3 x 10e11 cfu i.w. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319201|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 4 x 10e 11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319202|NCT00505713|Genetic|Rexin-G|Dosing Schedule: 2 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319203|NCT00505700|Drug|velcade|
16319204|NCT00505700|Drug|Idarubicin|
16319205|NCT00505700|Drug|Cytarabine|
16319206|NCT00505687|Drug|Rotigotine|"Rotigotine transdermal patches:
~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
~Optimal dosing:
~The maximum rotigotine dose allowed is 16 mg/24 hours."
16319207|NCT00505661|Drug|Letrozole|2.5 mg PO Once Daily
16319208|NCT00505648|Drug|Tegeline®|2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.
16319209|NCT00505635|Drug|Temozolomide|250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1
16319210|NCT00505635|Drug|Velban|1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4
16319211|NCT00505635|Drug|Cisplatin|20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4
16319212|NCT00505635|Drug|Interleukin-2|9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4
16319213|NCT00505635|Drug|Intron-A|5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5
16319214|NCT00505635|Drug|Thalidomide|400 mg By Mouth Daily
16319215|NCT00505622|Drug|Perampanel|
16319216|NCT00505609|Behavioral|Standard Days Method|The Standard Days Method is a fertility awareness-based method of family planning. Users avoid unprotected intercourse during cycle days 8 to 19. Study participants were for up to 13 cycles of method use.
16319217|NCT00505596|Behavioral|Informed free choice|Women will be instructed to view an updated prenatal testing decision aid and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study
16319218|NCT00505583|Drug|MOA-728|
16319219|NCT00505570|Device|AMPLATZER® PFO Occluder Device|PFO device closure
16319220|NCT00505557|Procedure|Transaxillary dual plane technique|
16319221|NCT00505544|Behavioral|Questionnaire|Questionnaires that ask about your sleep, symptoms, and mood.
16319222|NCT00505544|Device|Actigraph|Wear actigraph to collect information on activity levels and sleep patterns for one week.
16319223|NCT00505531|Drug|Tramadol Extended Release Oral Capsule|Tramadol ER- up to either 200 mg or 300 mg based on randomization
16319358|NCT00504543|Drug|Neoral|twice daily
16319225|NCT00505518|Drug|Psychotropic medication (at discretion of psychiatrist)|Antidepressant medication, prescribed at discretion of psychiatrist
16319226|NCT00505518|Behavioral|Collaborative psychiatric and primary medical care|Regular care visits from health workers
16319227|NCT00505505|Drug|Insulin (Actrapid)|50 UI Actrapid diluted in 50 ml of saline
16319228|NCT00505492|Drug|Carboplatin|AUC 5 by vein once every 28 Days
16319229|NCT00505492|Drug|Cisplatin|40 mg/m^2 by vein (IV) Weekly Over 4 Hours
16319230|NCT00505492|Drug|Paclitaxel|135 mg/m^2 by vein (IV) Once Every 28 Days
16319231|NCT00505466|Behavioral|Genetic Counseling|Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.
16319232|NCT00505453|Biological|Fluviral®|
16319233|NCT00505440|Behavioral|Telephone case management and motivational interviewing|'Telephone case management and motivational interviewing': Immediate screening results are given to the physician during the patient's visit. Telephone case management and motivational interviewing (MI) at 1, 6, and 9 weeks to enhance engagement and commitment to change
16319234|NCT00505440|Behavioral|Usual care|Usual care with mailed screening results
16319235|NCT00505427|Dietary Supplement|Alpha Lipoic Acid|
16319236|NCT00505414|Drug|Tapentadol in the Titration Phase|
16319237|NCT00505414|Drug|Morphine in the Maintenance Phase|"Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase.
~Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase."
16319238|NCT00505414|Drug|Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase|Participant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
16319239|NCT00505414|Drug|Tapentadol in the Maintenance Phase|The participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase.
16319240|NCT00505414|Drug|Morphine in the Titration Phase|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted.
16319241|NCT00505401|Biological|recombinant HIV-1 Tat protein|
16319242|NCT00505375|Drug|CTLA-4 Ig|Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
16319243|NCT00505375|Other|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
16319244|NCT00505362|Procedure|Rectus closure|Reapproximation of the rectus muscles with three-interrupted sutures
16319245|NCT00505349|Behavioral|Computer-based cognitive training|The experimental cognitive training program consists of interactive training exercises in which the participant responds to visual patterns and stimuli. The program is designed upon the principles of brain-plasticity, and, for the purposes of this study, is intended to be used for an 8-10 week period (40 total hours of training.)
16319246|NCT00505336|Drug|Eplerenone|oral Eplerenone titrated to 50mg for duration of 12 months
16319247|NCT00505336|Other|No additional treatment|normal disease modifying therapy for heart failure i.e. ACE-I, beta blockers
16319248|NCT00505336|Drug|Atorvastatin|oral Atorvastatin 40mg
16319249|NCT00505323|Device|Implantation of neurostimulators and their auxiliary components|"Implantation neurostimulators and their auxiliary components :
~Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482"
16319250|NCT00505310|Behavioral|Writing|20 minutes of writing on different topics at four different times.
16319251|NCT00505310|Behavioral|Questionnaire|Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
16319252|NCT00505284|Drug|Placebo|Placebo tablets, once daily, for 15 weeks (taken orally).
16319253|NCT00505284|Drug|E2007 (2 mg)|Perampanel, 2 mg once daily, for 15 weeks (taken orally).
16319254|NCT00505284|Drug|E2007 (4 mg)|Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).
16319255|NCT00505284|Drug|E2007 (6 mg)|Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).
16319256|NCT00505284|Drug|E2007 (8 mg)|Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).
16319257|NCT00505271|Genetic|Rexin-G|"Three patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held.
~At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity."
16319258|NCT00505258|Drug|ceftobiprole medocaril|
16319259|NCT00505245|Other|Interview|Complete interview
16319260|NCT00505245|Other|Quality-of-Life Assessment|Complete quality of life assessment
16319261|NCT00505245|Other|Questionnaire Administration|Complete questionnaires
16319419|NCT00504127|Drug|Naproxen 500 mg bid|Naproxen 500 mg bid
16319262|NCT00505232|Drug|Y-90 Ibritumomab tiuxetan|"Study Design
~The present study will be split into two cohorts:
~Patients younger than 60 years who will receive 8 chemotherapy cycles
~Patients older than 60 years who will receive 6 chemotherapy cycles
~The induction schema summarises as follows :
~Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy twice. Afterward, response will be evaluated, followed by, either, four cycles further patients younger than 60 years who will obtain a CR or PR, or 2 cycles patients older than 60 y. (see figure 1 and flow chart).
~Consolidation treatment will consist in a single dose of Y90-Ibritumomab -Tiuxetan (Zevalin) [0.4 mCi/Kg b.w or 0.3 mCi/kg if platelets < 100,000/µl] will be administered 8 to 12 weeks after last chemotherapy."
16319263|NCT00505219|Biological|Ixmyelocel-T|Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.
16319264|NCT00505219|Other|Standard of Care Only|Core decompression of the femoral head to remove necrotic tissue
16319265|NCT00505167|Drug|Memantine|Patients randomized to receive either memantine or donepezil
16319266|NCT00505167|Drug|Donepezil|Patients randomized to receive either memantine or donepezil
16319267|NCT00505154|Drug|Rosuvastatin|Rosuvastatin 10 mg tablets od for 6 months
16319268|NCT00505154|Drug|placebo|placebo
16319269|NCT00505128|Procedure|Endoscopic sphincterotomy|procedure
16319270|NCT00505102|Drug|Everolimus|cyclosporine dose reduced of 50% after introduction of everolimus
16319271|NCT00505089|Drug|ACZ885|
16319272|NCT00505089|Drug|ACZ885|
16319273|NCT00505089|Drug|ACZ885|
16319274|NCT00505089|Drug|ACZ885|
16319275|NCT00505076|Drug|MK-0777|MK-0777 GEM, 8 mg BID
16319276|NCT00505076|Drug|MK-0777|MK-0777 GEM, 3 mg BID
16319277|NCT00505076|Drug|placebo|2 tablets placebo BID
16319278|NCT00505063|Biological|Immunization Schedule patients <7 years.|"Time 0 months: Prevnar 13 #1, Hib #1
~Time 1 months: Pediarix #1
~Time 2 months: Prevnar 13 #2, Hib #2
~Time 3-4 months: Pediarix #2
~Time 4-6 months: Draw post vaccine titers
~Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations."
16319279|NCT00505063|Biological|Immunization Schedule patients > or = to 7 years and <11 years of age|"Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
~Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
~Time 2-3 months: Prevnar 13 #2, Hib #2
~Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations."
16319280|NCT00505063|Biological|Immunization Schedule patients > or = to 11 years of age|"Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
~Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
~Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
~Time 3-6 months: IPV, Draw post vaccine titers
~Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)"
16319281|NCT00505050|Other|Disease Program Management|"This DMP inclused intervention content with education for out patients and caregivers; medication management with optimized therapy based on guidelines, and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, physical therapists, psychologists; face-to-face individual/group communication, and telephone in-person; the intensity/complexity was long-term follow-up with 6 months interval repetitive education; the environment was hospital out-patient; and the outcomes measured were clinical, quality of life, and adherence.
~After randomization patients undergone our multidisciplinary education sessions 60-minute long that covered the basic principles related to heart failure. Telephone calls were used to reinforce the contents of the sessions of the ambulatory education activity, and monitoring of the compliance/adherence, symptoms/signs of worsening heart failure, and self-control mechanisms."
16319282|NCT00505037|Drug|ASP1585|Oral
16319283|NCT00505037|Drug|Placebo|Oral
16319284|NCT00505037|Drug|Sevelamer hydrochloride|Oral
16319285|NCT00505024|Behavioral|Interactive Voice Response System|Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
16319286|NCT00505024|Other|Symptoms Report|A report of severe symptoms will be sent to your doctor or nurse.
16319287|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319288|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 1 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319289|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 2 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319290|NCT00504998|Genetic|Rexin-G|Dose Schedule: 3 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has less than Grade 1 or less toxicity.
16319291|NCT00504998|Genetic|Rexin-G|Dosing Schedule: 4 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
16319292|NCT00504985|Behavioral|Surveys|2 surveys, taking about 10-15 minutes each, during Emergency Center visit
16319293|NCT00504972|Drug|hLL1|hLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.
16319294|NCT00504959|Drug|ranibizumab|
16319295|NCT00504946|Drug|prednisone, lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~20mg prednisone+ 0.3mg lactose"
16319296|NCT00504946|Drug|prednisone, colecalciferol, lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~20mg prednisone + 1000j colecalciferol + 0.3mg lactose"
16319297|NCT00504946|Drug|lactose|"Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
~0.3mg lactose"
16319298|NCT00504946|Drug|montelukast sodium|Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime
16319299|NCT00504946|Drug|lactose|Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
16319300|NCT00504933|Drug|bilastine|20 mg (encapsulated) tablets QD/14days
16319301|NCT00504933|Drug|Cetirizine|10 mg (encapsulated) tablets. QD/14 days
16319302|NCT00504933|Drug|Placebo|(encapsulated) Tablets QD/14 days
16319303|NCT00504920|Behavioral|Questionnaire|Questionnaires (30 minutes each) + instruction on telephone survey system for measuring symptoms. Questionnaires 2 times a week while in the hospital or until able to use the telephone survey system.
16319304|NCT00504907|Drug|BTA9881|Single oral escalating doses
16319305|NCT00504907|Drug|Placebo|
16319306|NCT00504894|Drug|Placebo|A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
16319307|NCT00504894|Drug|Propofol|A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
16319308|NCT00504894|Drug|Thiopental|A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
16319309|NCT00504881|Drug|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
16319310|NCT00504881|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
16319311|NCT00504855|Other|Casting using Gortex (waterproof) cast padding materials|
16319312|NCT00504855|Other|Casting using cotton/cotton-poly cast padding materials|
16319313|NCT00504842|Drug|MRX-801|
16319314|NCT00504842|Drug|Placebo|
16319315|NCT00504829|Drug|LCP-AtorFen|40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia
16319316|NCT00504829|Drug|atorvastatin|dyslipidemia and mixed dyslipidemia
16319317|NCT00504829|Drug|fenofibrate|dyslipidemia and mixed dyslipidemia
16319318|NCT00504816|Drug|GSK189075|Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
16319319|NCT00504816|Drug|Brevicon|Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
16319320|NCT00504803|Procedure|Mesenchymal stem cell infusion|Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.
16319321|NCT00504790|Drug|GSK923295|anti-mitotic compound
16319322|NCT00504777|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16319323|NCT00504777|Drug|Methotrexate|10-25mg/week po or parenteral
16319324|NCT00504764|Drug|Arsenic Trioxide|"Induction ATO 0.15 mg/kg/day IV until CR or a maximum of 60 days In isolated molecular relapse ATO will be administered at same dose, 5 days a week, during 6 weeks.
~Consolidation ATO 0.15 mg/kg/day IV 5 days week, during 5 weeks"
16319325|NCT00504764|Procedure|Autologous Transplantation|Autologous Transplantation
16319326|NCT00504764|Procedure|Allogenic Transplantation|Allogenic Transplantation
16319327|NCT00504764|Drug|ATRA|Consolidation: ATRA 45 mg/m²/day oral during 5 weeks
16319328|NCT00504751|Drug|bortezomib, dexamethasone, ifosfamide|"VIPER chemotherapy will be administered every 28 days at the following doses:
~Dexamethasone 40 mg IV days 1-4
~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
~Cisplatin 25 mg IV days 1-4
~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
~VELCADE 1.5 mg/m2 on days 2 and 5"
16319329|NCT00504751|Drug|mesna, cisplatin, etoposide, rituximab|"VIPER chemotherapy will be administered every 28 days at the following doses:
~Dexamethasone 40 mg IV days 1-4
~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
~Cisplatin 25 mg IV days 1-4
~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
~VELCADE 1.5 mg/m2 on days 2 and 5"
16319330|NCT00504725|Drug|Ketamine|Interventional
16319331|NCT00504725|Drug|0.9% saline|placebo
16319332|NCT00504712|Drug|Testosterone|Sustanon- 200mg- Intramuscular testosterone every 2 weeks
16319333|NCT00504712|Drug|saline|Saline injection every two weeks
16319334|NCT00504699|Procedure|Ovarian stimulation in vitro fertilization cryopreservation|Letrozole 5 mg/day during ovarian stimulation
16319335|NCT00504686|Other|manual therapy|manual therapy - thoracic spine thrust manipulation
16319336|NCT00504686|Other|exercise|therapeutic exercise
16319337|NCT00504673|Drug|insulin detemir|
16319338|NCT00504673|Drug|insulin NPH|
16319339|NCT00504673|Drug|insulin aspart|
16319340|NCT00504660|Drug|Capecitabine|Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
16319341|NCT00504660|Drug|Celecoxib (Celebrex)|Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
16319342|NCT00504660|Drug|Temozolomide|Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
16319343|NCT00504660|Drug|Lomustine|Arms 2,3 = 100 mg/m^2 PO on Day 4.
16319344|NCT00504660|Drug|6-Thioguanine|Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
16319345|NCT00504647|Device|Biventricular Pacemaker|
16319346|NCT00504634|Drug|Bortezomib|1 mg/m^2 IV On Days 1, 4, 8, and 11.
16319347|NCT00504608|Drug|Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)|
16319348|NCT00504595|Drug|ACZ885 (investigational)|The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
16319349|NCT00504595|Drug|Placebo|Matching placebo of ACZ885 was supplied in the form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
16319351|NCT00504556|Drug|Edoxaban (DU-176b)|30mg tablet once daily
16319352|NCT00504556|Drug|Edoxaban (DU-176b)|60mg tablet once daily
16319353|NCT00504556|Drug|Edoxaban (DU-176b)|30mg tablet two times a day
16319354|NCT00504556|Drug|Edoxaban (DU-176b)|60mg tablet two times a day
16319355|NCT00504556|Drug|warfarin|warfarin tablets
16319356|NCT00504543|Drug|AEB071|oral, twice daily
16319357|NCT00504543|Drug|Certican|twice daily
16319359|NCT00504530|Drug|Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)|
16319360|NCT00504517|Other|Evaluating Educational Models|Evaluating various forms of educational models for physicians.
16319361|NCT00504504|Drug|Rituximab|375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
16319362|NCT00504504|Drug|Adriamycin|25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
16319363|NCT00504504|Drug|Bleomycin|10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
16319364|NCT00504504|Drug|Vinblastine|6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
16319365|NCT00504504|Drug|Dacarbazine (DTIC)|375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
16319366|NCT00504491|Drug|Rituximab-CHOP-Alemtuzumab|Four Rituximab - CHOP courses will be given The courses will be given every 21 days
16319367|NCT00504478|Dietary Supplement|omega-3 fatty acids|omega-3 supplement will be given in addition to high complex carbohydrate diet.
16319368|NCT00504478|Other|high complex carbohydrate diet|
16319369|NCT00504465|Drug|dinoprostone|
16319370|NCT00504452|Drug|KP-1461|Oral dosage, 1600 mg bid for 124 days
16319371|NCT00504439|Drug|SB-656933-AAA|The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.
16319372|NCT00504439|Drug|Matching placebo|SB-656933-AAA matching placebo tablets will be administered orally.
16319373|NCT00504439|Drug|Simvastatin|Simvastatin will be provided as a 40 mg tablet.
16319374|NCT00504426|Drug|OPC-249|1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
16319375|NCT00504413|Drug|midazolam(drug), digoxin (drug)|Midazolam (2mg po) and digoxin (0.5mg po) will be administered one time, an hour apart. Blood concentration will be collected at various points in an 8 hour period.
16319376|NCT00504413|Drug|Bupropion (drug)|Bupropion (150mg po) will be administered one time on a separate visit. Blood concentrations will be collected at various points in a 72 hour period.
16319377|NCT00504413|Drug|Methadone (drug)|Methadone (10mg po) will be administered at a separate visit 2 weeks after the bupropion visit. The dose is given once. Blood concentrations will be measured at various points in a 72 hour period. Pupil constriction will be measured and urine will be collected during this period as well.
16319378|NCT00504400|Drug|Intravitreal injection ranibizumab|Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
16319379|NCT00504374|Behavioral|Questionnaire|Symptoms questionnaire lasting about 5 to 10 minutes.
16319380|NCT00504348|Drug|Tacrolimus|Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
16319381|NCT00504335|Drug|BIO 300 Capsules|
16319382|NCT00504322|Genetic|AdcuCD40L|Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10^11 particle units) will be used for all individuals enrolled in this efficacy study. Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo). This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.
16319383|NCT00504322|Genetic|Placebo|The placebo will be the salt water-sugar solution used as a vehicle for the vector.
16319384|NCT00504309|Drug|4/day of 4g P-OM3 capsules|4/day of 4g P-OM3 capsules for 8 weeks
16319385|NCT00504309|Drug|4/day of 1g P-OM3 capsules|4/day of 1g P-OM3 capsules for 8 weeks
16319386|NCT00504309|Drug|Corn Oil Placebo, 4 capsules/day for 8 weeks|4 capsules per day of corn oil placebo for 8 weeks
16319387|NCT00504296|Drug|HDAC inhibitor SB939|SB939 will be administered initially for 3 consecutive days every other week at the first dose level and then for 5 consecutive days every other week at escalating doses.
16319388|NCT00504296|Other|immunoenzyme technique|
16319389|NCT00504296|Other|immunohistochemistry staining method|
16319390|NCT00504296|Other|immunologic technique|
16319391|NCT00504296|Other|laboratory biomarker analysis|
16319392|NCT00504296|Other|liquid chromatography|
16319393|NCT00504296|Other|mass spectrometry|
16319394|NCT00504296|Other|pharmacological study|
16319395|NCT00504283|Drug|Toradol|
16319396|NCT00504283|Drug|Morphine|
16319397|NCT00504270|Drug|Placebo|po daily
16319398|NCT00504270|Drug|RG3421 120mg|120mg po daily
16319399|NCT00504270|Drug|RG3421 20mg|20mg po daily
16319400|NCT00504257|Drug|Avastin|Day 1, every 21 day cycle
16319401|NCT00504257|Drug|Docetaxel|Day 1, 8, every 21 day cycle
16319402|NCT00504244|Drug|switch to Myfortic|Myfortic 2 dd 720 mg
16319403|NCT00504244|Drug|continuation of azathioprine|Azathioprine 2 mg/kg
16319404|NCT00504231|Biological|Fluzone Influenza Vaccine (2007-2008)|Manufactured by Sanofi Pasteur
16319405|NCT00504205|Drug|multitargeted receptor tyrosine kinase inhibitor MP470|
16319406|NCT00504205|Other|laboratory biomarker analysis|
16319407|NCT00504205|Other|pharmacological study|
16319408|NCT00504205|Procedure|positron emission tomography|
16319409|NCT00504192|Drug|Gemcitabine and Oxaliplatin|gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks
16319410|NCT00504179|Procedure|Osteopathic Manipulative Treatment|
16319411|NCT00504166|Drug|alendronate sodium|alendronate sodium 70 mg tablet once week for 24 months
16319412|NCT00504166|Other|placebo comparator|placebo to match alendronate sodium one tablet once a week for 24 months
16319413|NCT00504153|Drug|dasatinib|
16319414|NCT00504153|Other|laboratory biomarker analysis|Correlative studies
16319415|NCT00504140|Drug|Etoposide|100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
16319416|NCT00504140|Drug|Interferon Alpha|5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
16319417|NCT00504127|Drug|Naproxcinod 375 mg bid|Naproxcinod 375 mg bid
16319418|NCT00504127|Drug|Naproxcinod 750 mg bid|Naproxcinod 750 mg bid
16319421|NCT00504114|Procedure|ACL Reconstruction Surgery|
16319422|NCT00504114|Procedure|Cartilage Resurfacing Surgery|
16319423|NCT00504114|Procedure|Total Knee Replacement|
16319424|NCT00504101|Drug|Arsenic trioxide|Arsenic Trioxide will be given on day -6, -5, -4,-3,-2 (total of 5 doses). The dose of Arsenic trioxide (ATO) is 0.25 mg/m2.
16319425|NCT00504101|Drug|Bortezomib|Bortezomib will be given on day -6, -4, -2 (total 3 doses) beginning at a dose of 0.8 mg/m2 each day of therapy.
16319426|NCT00504101|Drug|Melphalan|Melphalan will be given at 200 mg/m2 on day -2 (1 dose only)
16319427|NCT00504101|Biological|Autologous hematopoietic stem cell transplantation|On day 0 a minimal of 2 x 106 CD 34 cells/kg will be infused by central catheter according to institutional standards.
16319428|NCT00504088|Procedure|Bypass|
16319429|NCT00504088|Procedure|Silverhawk Plaque Excision|
16319430|NCT00504075|Biological|Gammaplex, intravenous immunoglobulin|"Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).
~The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX."
16319431|NCT00504062|Drug|budesonide|
16319432|NCT00504062|Drug|fluticasone|
16319433|NCT00504036|Device|inflatable intra-gastric balloon|inflatable intra-gastric balloon
16319434|NCT00504023|Drug|imiquimod|The patient will be seen in clinic every six weeks during treatment for examination. Imiquimod cream is to be applied 3 times per week for 12 weeks.
16319435|NCT00504023|Procedure|biopsy|Punch biopsy and photography will be performed at the baseline and 12 week time points.
16319436|NCT00504023|Procedure|therapeutic conventional surgery|If the lesion is still present after 12 weeks of therapy, the treating physician will recommend excision of the lesion four weeks after completion of therapy (week 16).
16319437|NCT00504010|Drug|Arnica Montana|Applied to lower extremity once a day for 3 days
16319438|NCT00504010|Drug|placebo cream|placebo cream applied to leg daily for 3 days
16319439|NCT00503997|Drug|oxaliplatin|"Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
~Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy."
16319440|NCT00503997|Drug|pemetrexed disodium|"Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
~Group II: Patients receive treatment as in group I. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy."
16319441|NCT00503984|Drug|Azacitidine|Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.
16319442|NCT00503984|Drug|Docetaxel|Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.
16319443|NCT00503984|Drug|Prednisone|Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.
16319444|NCT00503984|Genetic|GADD45α methylation and expression analysis|"Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.
~Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so."
16319445|NCT00503984|Drug|Pegfilgrastim|Growth factor support.Granulocyte-colony stimulating factor (G-CSF)
16319446|NCT00503984|Drug|Filgrastim|Growth factor support. Granulocyte-colony stimulating factor (G-CSF)
16319447|NCT00503971|Drug|Vorinostat plus Erlotinib|"Phase I:
~Dose level 1: 300 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2: 400 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2b: 300 mg V d1-7 and 15-21 every 28 days plus 100 mg E daily Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily
~Phase II:
~Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily"
16319448|NCT00503958|Genetic|DNA methylation analysis|
16319449|NCT00503958|Genetic|DNA stability analysis|
16319450|NCT00503958|Genetic|gene expression analysis|
16319451|NCT00503958|Other|epidemiologic study|
16319452|NCT00503958|Other|study of socioeconomic and demographic variables|
16319453|NCT00503958|Procedure|biopsy|
16319454|NCT00503958|Procedure|evaluation of cancer risk factors|
16319455|NCT00503958|Procedure|study of high risk factors|
16319456|NCT00503945|Device|Nasal continuous positive airway pressure (nCPAP)|
16319457|NCT00503932|Procedure|Proton Therapy|Radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all).
16319458|NCT00503932|Drug|Capecitabine|825 mg/m^2 by mouth (PO) twice daily on days receive radiation.
16319459|NCT00503919|Procedure|Multi-spectral Digital Colposcopy (MDC)|Use of a digital camera and a special light to take pictures of the cervix and vagina.
16319460|NCT00503906|Drug|Avastin|
16319461|NCT00503906|Drug|Gemcitabine|
16319462|NCT00503906|Drug|Abraxane|
16319463|NCT00503893|Behavioral|Questionnaire|Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.
16319464|NCT00503893|Other|Blood specimen|Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.
16319465|NCT00503880|Biological|filgrastim|subcutaneously one day prior to treatment
16319466|NCT00503880|Drug|clofarabine|single IV dose over 1 hour daily for 5 days
16319467|NCT00503880|Drug|cytarabine|subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion
16319468|NCT00503880|Genetic|microarray analysis|Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.
16319469|NCT00503880|Procedure|biopsy|bone marrow biopsy
16319470|NCT00503867|Device|SIR-Spheres microspheres|SIR-Spheres Yttrium-90 microspheres
16319471|NCT00503854|Behavioral|Questionnaire|Ancillary studies
16319472|NCT00503841|Drug|erlotinib hydrochloride|Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
16319473|NCT00503841|Other|immunohistochemistry staining method|Assessed at the time of the initial biopsy and at the time of surgery.
16319474|NCT00503841|Other|laboratory biomarker analysis|Correlative studies
16319475|NCT00503841|Procedure|biopsy|14 days prior to surgery
16319476|NCT00503841|Procedure|conventional surgery|14 days after taking study drug erlotinib hydrochloride.
16319477|NCT00503841|Procedure|neoadjuvant therapy|14 days after taking study drug erlotinib hydrochloride.
16319478|NCT00503828|Drug|Derris scandens Benth extracts|Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
16319479|NCT00503828|Drug|naproxen|Naproxen 500 mg/day for 4 weeks
16319480|NCT00503815|Drug|BLI-800|
16319481|NCT00503815|Drug|Polyethylene glycol 3350 based bowel preparation|
16319482|NCT00503802|Procedure|Radiofrequency Turbinate Reduction|Radiofrequency Turbinate Reduction
16319483|NCT00503802|Procedure|Sham RF|The steps of the procedure are as follows: 1) application of topical anesthetic to the turbinate mucosa bilaterally; 2) injection of 1.0 ml of lidocaine 1% with epinephrine 1:100,000 with a 30-gauge needle into each inferior turbinate anteriorly; 3) delay five minutes for local anesthetic to take full effect; 4) re-insertion of the anesthetic needle to check for complete anesthesia on one side, and injection of another 1.0 ml of lidocaine 1% with epinephrine 1:100,000 5) placement of the radiofrequency electrode (23-gauge, 1 cm long) into the inferior turbinate; 6) delivery of 300 Joules of radiofrequency energy to the turbinate over 29 seconds (no energy will be delivered in sham procedure)7) placement of a cotton pledget (soaked in oxymetazoline solution 0.05%) against the treatment site 8) repeat steps 3 - 8 for the contra-lateral inferior turbinate; 9) removal of the cotton pledgets after several minutes; and 11) observation of hemostasis.
16319484|NCT00503789|Procedure|fecal bacteria analysis|ad lib feeding
16319485|NCT00503776|Behavioral|exercise intervention|Patients undergo low weight resistance training.
16319486|NCT00503776|Drug|amifostine trihydrate|Given subcutaneously
16319487|NCT00503776|Procedure|therapeutic dietary intervention|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
16319488|NCT00503763|Drug|Simvastatin|
16319489|NCT00503750|Drug|Pre operativeTrastuzumab|"Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.
~As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52."
16319490|NCT00503750|Drug|ABI-007 (Abraxane)|ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8).
16319491|NCT00503750|Drug|Vinorelbine|Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).
16319492|NCT00503737|Behavioral|National Colorectal Cancer Roundtable Toolbox|
16319493|NCT00503724|Drug|enzastaurin hydrochloride|Participants receive 200, 260, 340, or 440 mg/m2/day of enzastaurin orally once daily for 28 days (one course) during the dose escalation phase of the study. To study the toxicity profile of the MTD or phase II recommended dose established during the dose escalation phase, participants receive twice daily doses of enzastaurin orally at the phase II recommended dose for 28 days (one course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 13 courses (approximately one year).
16319494|NCT00503711|Drug|Vandetanib|100 mg every other day, 100mg once daily
16319495|NCT00503711|Drug|Vandetanib 300 mg|300mg once daily
16319496|NCT00503698|Drug|somatropin|20 mcg/kg/day, injected s.c. (under the skin)
16319497|NCT00503698|Drug|placebo|Placebo injected s.c (under the skin)
16319498|NCT00503685|Biological|IMC-A12|10 milligrams/kilogram (mg/kg) intravenous infusion every 2 weeks.
16319499|NCT00503685|Biological|cetuximab|Participants will receive cetuximab 500 milligrams/square meter (mg/m²) intravenous over 2 hours every 2 weeks.
16319500|NCT00503659|Procedure|Bronchial methacholine provocation|A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)
16319501|NCT00503659|Procedure|Bronchial methacholine provocation|A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
16319502|NCT00503646|Other|communication intervention|
16319503|NCT00503646|Other|counseling intervention|
16319504|NCT00503646|Other|questionnaire administration|
16319505|NCT00503646|Procedure|psychosocial assessment and care|
16319506|NCT00503620|Drug|Botulinum Toxin A|Injection into the gastrocnemius/soleus muscles for spasticity
16319507|NCT00503607|Drug|BLI-800|
16319508|NCT00503607|Drug|Polyethylene glycol 3350 based bowel preparation|
16319509|NCT00503594|Drug|Methotrexate and temozolomide|Methotrexate and temozolomide
16319510|NCT00503594|Drug|Methotrexate , procarbazine ,vincristine ,cytarabine|Methotrexate , procarbazine ,vincristine ,cytarabine
16319511|NCT00503581|Procedure|Biopsy|Undergo biopsy
16319512|NCT00503581|Other|Laboratory Biomarker Analysis|Correlative studies
16319513|NCT00503581|Drug|Megestrol Acetate|given orally
16319514|NCT00503581|Other|Pharmacological Study|Correlative studies
16319515|NCT00503581|Other|Quality-of-Life Assessment|Ancillary studies
16319516|NCT00503581|Procedure|Therapeutic Conventional Surgery|undergo hysterectomy
16319517|NCT00503568|Biological|Ad100-gp96Ig-HLA A1|Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
16319518|NCT00503542|Drug|Terazol or oral fluconazole for candidal vaginitis|Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1
16319519|NCT00503542|Drug|Metronidazole or Clindamycin for Bacterial Vaginosis|Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin
16319520|NCT00503542|Drug|Flagyl for definitively diagnosed vaginal trichomoniasis|Metronidazole 2 gms po x 1
16319687|NCT00502047|Drug|Plantago ovata husk|
16319521|NCT00503542|Other|Empiric Management|In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
16319522|NCT00503529|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)
16319523|NCT00503516|Drug|Megestrol acetate|1 sachet of powder containing 160 mg of megestrol acetate b.i.d. during 24 weeks
16319524|NCT00503516|Drug|Placebo|1 sachet of 160 mg of placebo b.i.d.
16319525|NCT00503503|Drug|Enbrel (etanercept)|
16319526|NCT00503490|Drug|MP-376 (Levofloxacin solution for Inhalation)|40, 80, 120mg RDD
16319527|NCT00503490|Drug|placebo|BID
16319528|NCT00503477|Drug|AZD2171|oral tablet
16319529|NCT00503451|Drug|LBH589|
16319530|NCT00503438|Device|Salto Talaris Ankle|Salto Talaris Anatomic Ankle total joint prosthesis
16319531|NCT00503425|Drug|Rituximab [MabThera/Rituxan]|1000 mg IV on days 1 and 15
16319532|NCT00503412|Drug|AZD2171|oral 14C
16319533|NCT00503399|Drug|Teriparatide|20 µg/day sc for 18 months
16319534|NCT00503399|Drug|Risedronate|35 mg/week po for 18 months
16319535|NCT00503386|Drug|Palonosetron|
16319536|NCT00503386|Drug|Granisetron|
16319537|NCT00503360|Drug|SAD448|
16319538|NCT00503347|Drug|bavituximab|The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab.
16319539|NCT00503334|Dietary Supplement|preOP booster (oral nutritional supplement, food for special medical purposes)|3x1 dosage pre-operatively
16319540|NCT00503321|Drug|Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)|S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
16319541|NCT00503321|Drug|Tegafur/gimeracil/oteracil potassium (S-1)|S-1 80mg/m2, 4weeks on followed by 2 weks off
16319542|NCT00503308|Procedure|Abbreviated HIV test counseling|abbreviated HIV pre-test counseling
16319543|NCT00503295|Biological|REOLYSIN®|REOLYSIN® is given intravenously at a dose of 3x10E10 TCID50 over 60 minutes on Days 1-5 of a 28 day cycle.
16319544|NCT00503269|Procedure|Hemorrhoidectomy|Hemorrhoidectomy under local anaesthesia
16319545|NCT00503269|Procedure|Hemorrhoidectomy|General anaesthetic haemorrhoidectomy
16319546|NCT00503256|Behavioral|Questionnaire|Questionnaires each taking 60 minutes to complete.
16319547|NCT00503243|Drug|Delayed and extended release mesalazine|
16319548|NCT00503230|Behavioral|Standard Care Intervention (SCI)|Standard Care Intervention (SCI)
16319549|NCT00503230|Behavioral|Culturally Tailored Intervention (CTI)|Culturally Tailored Intervention (CTI)
16319550|NCT00503217|Drug|Tryptorelin|
16319551|NCT00503204|Drug|Cediranib|oral tablet
16319552|NCT00503204|Drug|Lomustine|oral capsule
16319553|NCT00503191|Behavioral|NeuroModulation Technique|NeuroModulation Technique is an informational technique that works by identifying and bringing awareness of the mind-body to incorrect informational states of the nervous system which has led to illness or maladaptive behavior. NeuroModulation Technique then directs the body to correct these information states, thereby helping the nervous system resume more adaptive functioning.
16319554|NCT00503178|Procedure|Biological imaging guided antalgic radiotherapy|Biological imaging guided antalgic radiotherapy is followed.
16319555|NCT00503165|Biological|Menitorix (MenC and Hib conjugate)|
16319556|NCT00503152|Drug|Benazepril|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16319557|NCT00503152|Drug|Valsartan|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16319558|NCT00503152|Drug|Benazepril/Valsartan|After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16319559|NCT00503139|Drug|Enbrel (etanercept)|Enbrel 10 to 25 mg twice a week subcutaneous injection
16319560|NCT00503126|Drug|bivalirudin|anticoagulation
16319561|NCT00503113|Drug|ibandronate [Bonviva/Boniva]|3mg intravenous (iv) injection every 3 months
16319562|NCT00503113|Drug|ibandronate [Bonviva/Boniva]|3mg intravenous (iv) infusion every 3 months
16319563|NCT00503113|Drug|Alendronate|70mg per oral (po) weekly
16319564|NCT00503100|Device|Thermal stimulation|Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.
16319565|NCT00503087|Procedure|Saline Injection|
16319566|NCT00503087|Device|Pneumatic Skin Flattening (PSF)|
16319567|NCT00503074|Behavioral|TV modification|Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.
16319757|NCT00501501|Procedure|Cesarean section|
16319568|NCT00503074|Behavioral|safety and injury prevention|Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.
16319569|NCT00503035|Drug|Celecoxib|400 mg by mouth twice daily x 6 months
16319570|NCT00503035|Procedure|Colonoscopy Biopsy|Up to 23 additional colon tissue biopsies (the size of a pencil tip), additional 20 minutes on colonoscopy procedure
16319571|NCT00503022|Drug|ACZ885|
16319572|NCT00503009|Drug|fluticasone propionate/salmeterol|comparator
16319573|NCT00503009|Drug|fluticasone propionate|Comparator
16319574|NCT00503009|Drug|placebo|Placebo
16319575|NCT00502996|Drug|Methotrexate|>=15 mg po/week
16319576|NCT00502996|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
16319577|NCT00502983|Behavioral|Interview|Interview lasting approximately 50 minutes.
16319578|NCT00502970|Drug|16 weeks Interferon Tiw with Ribavirin|16 weeks Interferon Tiw
16319579|NCT00502970|Drug|24 weeks Interferon|24 weeks Interferon Tiw with Ribavirin
16319580|NCT00502957|Behavioral|Biofeedback|
16319581|NCT00502944|Behavioral|Counselor-based HIV screening|Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
16319582|NCT00502944|Behavioral|Emergency staff member-based HIV screening|Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months
16319583|NCT00502918|Device|CLM - HA Continuous Monitoring System Heart Application|
16319584|NCT00502905|Drug|Busulfan|130 mg/m^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine.
16319585|NCT00502905|Drug|Fludarabine|40 mg/m^2 through a central venous catheter over one hour, once a day, for four days.
16319586|NCT00502892|Drug|Topotecan|0.5 mg/m^2 IV Daily x 3 Days
16319587|NCT00502892|Drug|Ifosfamide|1.8 grams/m^2 IV Over 1 Hour x 5 Days
16319588|NCT00502892|Drug|Carboplatin|AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days]
16319589|NCT00502879|Drug|Enbrel (etanercept)|
16319590|NCT00502853|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16319591|NCT00502853|Drug|Methotrexate|10-25mg/week
16319592|NCT00502840|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
16319593|NCT00502827|Behavioral|Cell Phone Intervention|Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
16319594|NCT00502827|Other|Recommended Standard of Care|Advice from your physician to stop smoking and written materials designed to help you quit smoking.
16319595|NCT00502814|Procedure|3-D Optical Surface Scan|3-D digitized images of the breasts and chest will be taken over a period of five minutes.
16319596|NCT00502814|Procedure|Mechanical Testing|A small device with a mild suction will be used to measure how the skin tends to stretch.
16319597|NCT00502814|Procedure|Cutaneous Ultrasound|Cutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded.
16319598|NCT00502814|Procedure|Breast MRI and/or CT|Imaging of the breasts and chest using an MRI and/or CT scan over about one hour.
16319599|NCT00502801|Drug|doripenem|1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
16319600|NCT00502788|Drug|Peginterferon Alfa-2a and Ribavirin|"Patients will be treated with alfa-2a and ribavirin as follows:
~Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly."
16319601|NCT00502788|Drug|Ribavirin|Ribavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight > 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
16319602|NCT00502775|Drug|fluticasone furoate, fexofenadine|
16319603|NCT00502762|Drug|topotecan|
16319604|NCT00502749|Behavioral|Exercise program|Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.
16319605|NCT00502749|Behavioral|Questionnaires|Questionnaires taking 15 minutes to complete.
16319606|NCT00502736|Drug|ibandronate [Bondronat]|6mg iv on days 1-3
16319607|NCT00502723|Procedure|Radical retropubic prostatectomy|Radical retropubic prostatectomy
16319608|NCT00502723|Procedure|Radical laparoscopy prostatectomy|Radical laparoscopy prostatectomy
16319609|NCT00502710|Drug|Placebo|Placebo po daily.
16319610|NCT00502710|Drug|RO4876904|Escalating doses, at a starting dose of 12.5mg po daily.
16319611|NCT00502697|Behavioral|Targeted Nurse Home Visits|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic care. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
16319612|NCT00502697|Other|Conventional prenatal/postpartum care|Women in this group received conventional prenatal care and postpartum clinic care.
16319613|NCT00502684|Drug|Propranolol, etodolac|propranolol 10 mg X 4 /day, starting on day -3 pre-op, for 6 days, till POD 2 Etodolac 400 mg X2/day, starting on day -3 pre-op, for 6 days, till POD 2
16319614|NCT00502671|Drug|capecitabine [Xeloda]|1250mg/m2 po bid on days 1-14 of each 3 week cycle
16319615|NCT00502658|Behavioral|Dietary supplement containing vitamins, minerals, and herbs|
16319616|NCT00502658|Behavioral|Shakes with nutrients and herbs|
16319617|NCT00502658|Behavioral|Control dietary supplement|
16319618|NCT00502658|Behavioral|Isocaloric, isonitrogenous control shakes without herbs|
16319619|NCT00502658|Behavioral|Personal energy tracking tool|
16319620|NCT00502645|Device|CS-1 DECISION SUPPORT SYSTEM|
16319621|NCT00502632|Drug|Urokinase and Dornase alfa|"Intrapleural administration of:
~Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
~Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days"
16319688|NCT00502034|Drug|Interferon Alfa-2a|Interferon Alfa-2a in combination with Interleukin
16319622|NCT00502632|Drug|Urokinase|"Intrapleural administration of:
~Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
~25ml normal saline, twice daily for 4 days"
16319623|NCT00502619|Procedure|Acupuncture|A specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks.
16319624|NCT00502619|Other|Treadmill Exercise|After the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments.
16319625|NCT00502593|Biological|Pandemic Influenza Vaccine (GSK1562902A)|2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.
16319626|NCT00502593|Biological|Fluarix™|2 doses, intramuscular injection on Days 0 and 21.
16319627|NCT00502580|Behavioral|Interview|Interview taking about 10 minutes to complete.
16319628|NCT00502567|Drug|AZD2171|oral tablet once daily
16319629|NCT00502567|Drug|FOLFOX|intravenous infusion
16319630|NCT00502567|Drug|Pemetrexed|intravenous infusion
16319631|NCT00502567|Drug|Irinotecan (administered with & without Cetuximab)|intravenous injection
16319632|NCT00502567|Drug|Docetaxel|intravenous infusion
16319633|NCT00502554|Procedure|photopheresis|2-day cycles of photopheresis every 3 weeks for 3 months
16319634|NCT00502541|Drug|fluocinolone acetonide|fluocinolone acetonide 0.59 mg intravitreal implant
16319635|NCT00502541|Procedure|Standard of Care|Repeat macular grid laser or observation
16319636|NCT00502528|Drug|Placebo|Peri-interventional
16319637|NCT00502528|Drug|BQ-123|Peri-interventional
16319638|NCT00502515|Drug|SSR180575|Oral, once daily dosing
16319639|NCT00502515|Drug|Placebo|Oral, once daily dosing
16319640|NCT00502502|Behavioral|Questionnaire|Weekly questionnaires lasting about 30 minutes.
16319641|NCT00502489|Procedure|Closed-loop sytem for5 weaning from mechanical ventilation|
16319642|NCT00502476|Procedure|Bathing with Chlorhexidine Impregnated Washcloths|
16319643|NCT00502463|Procedure|radio-immunotherapy|
16319644|NCT00502437|Drug|GRANISETRON|
16319645|NCT00502424|Device|Splint|
16319646|NCT00502411|Drug|Doxorubicin|17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4.
16319647|NCT00502411|Radiation|Radiation Therapy|Radiation treatments 5 days a week for 6 - 6 1/2 weeks. 60 Gy in 6 weeks (negative resection margin) to 66 Gy in 6.5 weeks (positive resection margin).
16319648|NCT00502398|Procedure|Blood test|
16319649|NCT00502385|Drug|AZD2171|
16319650|NCT00502372|Dietary Supplement|Nutritional Supplement/Amino acids and HMB|Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
16319651|NCT00502372|Dietary Supplement|Juven|comparison of Juven with arginine only product in wound healing
16319652|NCT00502359|Device|capillary blood glucose measurement|
16319653|NCT00502346|Drug|PM10|
16319654|NCT00502320|Drug|Ramelteon|one 8 mg tablet at bed for up to 4 months
16319655|NCT00502320|Drug|Placebo|one tablet at bedtime for up to 4 months
16319656|NCT00502307|Drug|Tivozanib (AV-951)|solid oral dosage form taken daily for three weeks per one month cycle
16319657|NCT00502307|Drug|Placebo comparator|solid oral capsule containing excipients dosed daily for three weeks per month
16319658|NCT00502294|Drug|Visilizumab (HuM291; Nuvion®)|
16319659|NCT00502281|Drug|highly purified urinary FSH|
16319660|NCT00502281|Behavioral|timed intercourses, intrauterine insemination|
16319661|NCT00502268|Drug|Doxercalciferol administration|Doxercalciferol administration
16319662|NCT00502268|Drug|Doxercalciferol administered by 1-84-7-84|Doxercalciferol administered by 1-84-7-84
16319663|NCT00502255|Device|Health Buddy system|Patients are followed on distance by the Health Buddy system.
16319664|NCT00502255|Device|Telemonitoring in patients with heart failure|Health Buddy in patients home situation.
16319665|NCT00502242|Drug|ramipril|Capsule - initial treatment is 5 mg (active)- oral - once per day
16319666|NCT00502242|Drug|ramipril|Capsule - initial treatment is 5 mg (placebo) - oral - once per day
16319667|NCT00502229|Drug|Clomiphene citrate, metformin, highly purified urinary FSH|
16319668|NCT00502216|Drug|Naltrexone|Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
16319669|NCT00502216|Drug|Varenicline|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day; Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
16319670|NCT00502203|Drug|Carboplatin|AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses
16319671|NCT00502203|Drug|Paclitaxel|175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
16319672|NCT00502190|Device|Silicon ring positioned in the vagina, around the cervix|Silicon ring positioned in the vagina, around the cervix
16319673|NCT00502177|Behavioral|Questionnaire|QOL Questionnaires taking a total of 10 minutes to complete.
16319674|NCT00502164|Drug|AZD2171|
16319675|NCT00502138|Drug|Continuous Pramlintide infusion|pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
16319676|NCT00502125|Procedure|Reflectance Confocal Imaging|A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.
16319677|NCT00502112|Drug|lintuzumab|4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
16319678|NCT00502112|Drug|lenalidomide|10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
16319679|NCT00502099|Drug|Pegylated interferon alpha 2a|Injections: 180 ug once per week
16319680|NCT00502099|Drug|Ribavirin|Tablets, 1000-1200 daily
16319681|NCT00502099|Drug|Pegylated interferon alpha 2 b plus ribavirin|Pegylated interferon alpha 2 b injections
16319682|NCT00502086|Dietary Supplement|Viusid (nutritional supplement)|Viusid three sachets daily during 96 weeks
16319683|NCT00502086|Other|Placebo|Placebo three sachets daily during 96 weeks
16319684|NCT00502073|Drug|cyclosporine|
16319689|NCT00502034|Drug|Interleukin-2|Interferon Alfa-2a in combination with Interleukin
16319690|NCT00502021|Dietary Supplement|Placebo|Manioc powder (placebo) 60 g/day
16319691|NCT00502021|Dietary Supplement|Alpha-linolenic acid/ALA|Flaxseed powder 60 g/day (10 g ALA)
16319692|NCT00502021|Dietary Supplement|Alpha linolenic acid/ALA|Flaxseed oil 30 ml/day (10 g ALA)
16319693|NCT00502021|Dietary Supplement|Placebo|Safflower oil 30 ml/day
16319694|NCT00502008|Drug|Coccinia Cordifolia (herbal extract)|
16319695|NCT00501995|Drug|IV Cyclophosphamide|Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
16319696|NCT00501982|Drug|Poractant alfa (Curosurf®)|
16319697|NCT00501969|Drug|Rotigotine|"Rotigotine trans-dermal patches once daily:
~20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)"
16319698|NCT00501956|Drug|Intradialytic Parenteral Nutrition (IDPN)|compounded IDPN, 3 x/week, 16 weeks intervention
16319699|NCT00501943|Drug|Avonex (Interferon beta 1a)|
16319700|NCT00501943|Drug|Riluzole|
16319701|NCT00501943|Drug|Placebo|
16319702|NCT00501930|Drug|GSK189075|
16319703|NCT00501917|Drug|G-CSF with/without darbepoetin, peripheral blood stem cell infusion|
16319704|NCT00501904|Drug|Metformin|
16319705|NCT00501891|Drug|Bevacizumab|Bevacizumab administered intravenously 10mg/kg every other week.
16319706|NCT00501891|Drug|Metronomic Temozolomide|Temozolomide 50mg/m2 given orally on a daily basis.
16319707|NCT00501878|Drug|2.5% or 10% phenylephrine|
16319708|NCT00501865|Drug|GW273225|GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature.
16319709|NCT00501852|Drug|NVA237|single-dose dry-powder inhaler (SDDPI)
16319710|NCT00501852|Drug|Placebo|single-dose dry-powder inhaler (SDDPI)
16319711|NCT00501852|Drug|Tiotropium|Handihaler inhaler
16319712|NCT00501839|Drug|clomiphene citrate|
16319713|NCT00501826|Drug|Cyclophosphamide|Given IV
16319714|NCT00501826|Drug|Cytarabine|Given IV
16319715|NCT00501826|Drug|Dexamethasone|Given IV or PO
16319716|NCT00501826|Drug|Doxorubicin Hydrochloride|Given IV
16319717|NCT00501826|Drug|Mercaptopurine|Given PO
16319718|NCT00501826|Drug|Methotrexate|Given IV and PO
16319719|NCT00501826|Drug|Nelarabine|Given IV
16319720|NCT00501826|Drug|Pegaspargase|Given IV
16319721|NCT00501826|Drug|Prednisone|Given PO
16319722|NCT00501826|Drug|Venetoclax|Given PO
16319723|NCT00501826|Drug|Vincristine Sulfate|Given IV
16319724|NCT00501813|Procedure|Hepatectomy|irregular Hepatectomy
16319725|NCT00501813|Procedure|TACE combined with local regional therapies without hepatectomy|TACE combined with RFA, MCT, PEI, and so on.
16319726|NCT00501787|Drug|Metformin|
16319727|NCT00501761|Behavioral|Personalized Exercise Program|Walking up to thirty minutes on most days of the week.
16319728|NCT00501761|Behavioral|Questionnaire|Questionnaires regarding physical activity, exercise, and quality of life.
16319729|NCT00501761|Behavioral|Suggested Exercise Program|Exercise program performed over 7 days.
16319730|NCT00501748|Drug|Rituximab|Rituximab is a highly purified, 1328-amino acid antibody with an approximate molecular mass of 145 kD. Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials. In this single arm study all subjects are treated with two cycles of rituximab. Each cycle consists of two 1000 mg infusions administered two weeks apart. The cycles of rituximab treatment are administered at baseline and at 9 months.
16319731|NCT00501735|Drug|Forodesine 200 mg|2 x 100mg tablets once daily
16319732|NCT00501722|Drug|satavaptan (SR121463B)|
16319733|NCT00501709|Drug|Belatacept and Raptiva|immunosuppressant agent to prevent rejection in transplant recipients
16319734|NCT00501696|Drug|4.5 mg Naltrexone|low dose naltrexone 4,5mg on the multiple sclerosis quality of life inventory (MSQLI54)
16319735|NCT00501696|Drug|Naltrexone|4,5mg low dose naltrexone on the multiple sclerosis quality of life inventory (MSQLI54)
16319736|NCT00501683|Drug|Radiolabelled GSK189075|
16319737|NCT00501670|Procedure|Herpes zoster sampling procedure for VZV PCR|Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
16319738|NCT00501670|Procedure|Blood sampling|Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
16319739|NCT00501657|Drug|Sitagliptin|100mg mane for 2 days
16319740|NCT00501657|Drug|Placebo|100mg mane for 2 days
16319741|NCT00501644|Drug|Carboplatin|AUC of 5 by 1 hour IV infusion every 28 days.
16319742|NCT00501644|Drug|GM-CSF (Sargramostim)|Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy.
16319743|NCT00501644|Drug|Interferon Gamma|0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle).
16319744|NCT00501631|Drug|VIVITROL 380 mg|Administered via IM injection once every 4 weeks.
16319745|NCT00501631|Drug|Placebo for VIVITROL 380 mg|Administered via IM injection once every 4 weeks.
16319746|NCT00501618|Drug|Fazaclo|single-arm
16319747|NCT00501605|Drug|AZD2171|
16319748|NCT00501592|Drug|INT-747|25 mg by mouth once daily, 50 mg by mouth once daily
16319749|NCT00501592|Drug|Placebo|Placebo
16319750|NCT00501579|Drug|Difluprednate|
16319751|NCT00501579|Drug|Prednisolone Acetate|
16319752|NCT00501566|Drug|satavaptan (SR121463B)|
16319753|NCT00501540|Drug|Lithium Carbonate|Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.
16319754|NCT00501527|Biological|Immunotherapy with modified extract of P. pratense pollen|Sublingual (2 drops daily)
16319755|NCT00501527|Other|Placebo|Placebo 2 drops daily
16319758|NCT00501501|Procedure|Vaginal delivery|
16319759|NCT00501488|Drug|rosiglitazone|
16319760|NCT00501475|Drug|NAC Bicarbonate|
16319761|NCT00501462|Drug|GSK189075|single 250 mg dose of drug
16319762|NCT00501449|Behavioral|Questionnaire|Mailed packets including cover letter describing purpose of study, study questionnaire, and return envelope.
16319763|NCT00501410|Drug|5-FU|2400 mg/m^2 by vein over 46 Hours On Days 1 & 2.
16319764|NCT00501410|Drug|Cetuximab|Initial Dose = 400 mg/m^2 by vein, then 250 mg/m^2 Weekly On Days 1 & 8
16319765|NCT00501410|Drug|Dasatinib|Starting dose level: 100 mg by mouth daily on days 1-14.
16319766|NCT00501410|Drug|Leucovorin|400 mg/m^2 by vein on day 1.
16319767|NCT00501410|Drug|Oxaliplatin|85 mg/m^2 by vein on day 1.
16319768|NCT00501397|Drug|ketoconazole|
16319769|NCT00501397|Drug|GSK189075|
16319770|NCT00501384|Drug|satavaptan (SR121463B)|
16319771|NCT00501371|Drug|MCS|soft-gel capsule, 15 mg/cap., Qd, 12 weeks
16319772|NCT00501371|Drug|Placebo|soft-gel capsule, Qd, 12 weeks
16319773|NCT00501345|Drug|Aspirin|325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily
16319774|NCT00501332|Biological|Maxy-G34|Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles.
16319775|NCT00501319|Behavioral|Interactive Voice Response (IVR)|Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
16319776|NCT00501319|Behavioral|Questionnaire|Questionnaires taking 20 minutes to complete.
16319777|NCT00501293|Drug|Methylphenidate Transdermal System|One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
16319778|NCT00501280|Behavioral|Interview|Interview by telephone or on-site in language of choice (English or Spanish), 60 to 70 minutes to complete the mother's and the child participants' questionnaires
16319779|NCT00501267|Drug|solabegron and oxybutynin|
16319780|NCT00501254|Drug|Slow release acetyl salicylic acid|
16319781|NCT00501254|Behavioral|Antithrombotic effect|
16319782|NCT00501241|Drug|ATI-7505|Tablet,placebo, BID
16319783|NCT00501241|Drug|ATI-7505|ATI-7505 20 mg BID for 4 weeks
16319784|NCT00501241|Drug|ATI-7505|tablet, 40 mg, BID, $ weeks
16319785|NCT00501241|Drug|ATI-7505|80 mg ATI-7505, BID for 4 weeks
16319786|NCT00501241|Drug|ATI-7505|120 mg ATI-7505, BID, for 4 weeks
16319787|NCT00501228|Drug|Filgrastim|5 mg/kg ID Once Daily x 1 Week
16319788|NCT00501215|Procedure|Parathyroid Surgery|Parathyroid surgery 1-3 weeks after the first PSG.
16319789|NCT00501215|Behavioral|Telephone Interview|Interview about sleep quality lasting 15-20 minutes.
16319790|NCT00501215|Procedure|Parathyroid Surgery|Parathyroid surgery after completing the second PSG and after the study participation ends.
16319791|NCT00501215|Behavioral|Polysomnography (PSG)|"2 overnight sleep tests
~Group 1: First PSG 1-3 weeks before surgery + Second PSG 6-8 weeks after surgery
~Group 2: First PSG 1-3 weeks before phone interview + Second PSG 6-8 weeks after phone interview"
16319792|NCT00501202|Drug|placebo|twice daily for 4 weeks
16319793|NCT00501202|Drug|RWJ-333369 (carisbamate)|200 mg tablet twice daily for 4 weeks
16319794|NCT00501189|Biological|human papillomavirus vaccine L1, type 6,11,16,18|Subjects are those getting gradasil vaccination already. This is really not an intervention
16319795|NCT00501176|Procedure|Plastic and metalic stent inserion|Patient randomizes to metal or plastic insertion prior to Whipple procedure
16319796|NCT00501150|Drug|linezolid|
16319797|NCT00501137|Biological|HPV (Human Papillomavirus) Vaccine|HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
16319798|NCT00501124|Drug|Clevudine|
16319799|NCT00501124|Biological|Purified hepatitis B surface antigen|
16319800|NCT00501111|Drug|AZD3480|3 oral doses
16319801|NCT00501111|Drug|Donepezil|
16319802|NCT00501098|Drug|Caspofungin|"Patients will receive caspofungin, starting from the first day of induction chemotherapy for leukemia, as a single daily dose intravenously at the dosage of 70 mg q.d. and followed by 50 mg q.d. thereafter until documentation of complete hematologic remission after the first induction cycle or of leukemia persistence after one cycle of induction and one cycle of salvage chemotherapy.
~No stratification is planned."
16319803|NCT00501085|Device|LAP-BAND AP Adjustable Gastric Banding System|Reduction of food intake due to creation of smaller stomach pouch.
16319804|NCT00501072|Device|Real-Time Continuous Glucose monitoring System (RT-CGMS)|
16319805|NCT00501059|Drug|Aspirin (Acetylsalicylic acid, BAYE4465)|100mg enteric coated Aspirin, taken daily
16319806|NCT00501059|Drug|Placebo|Placebo, taken daily
16319807|NCT00501046|Drug|Placebo|9g /day (3 times a day)
16319808|NCT00501046|Drug|AST-120|9g /day (3 times a day)
16319809|NCT00501033|Device|Mechanical induction of labor|
16319810|NCT00501033|Device|Double Balloon|
16319811|NCT00501033|Device|Foley Catheter|
16319812|NCT00501020|Drug|Rosiglitazone|
16319814|NCT00500981|Procedure|Volume challenge|
16319815|NCT00500981|Procedure|Ultrasound evaluation of internal jugular vein|
16319816|NCT00500968|Procedure|stent|ERCP guided stent insertion before transection of the gland
16319817|NCT00500968|Procedure|Distal pancreatectomy|conventional distal pancreatectomy
16319818|NCT00500955|Drug|Rosiglitazone|
16319819|NCT00500942|Behavioral|Questionnaire|Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.
16319820|NCT00500929|Drug|CMI X-11S|
16319821|NCT00500916|Device|ProSeal LMA|GEB vs digital vs introducer tool
16319822|NCT00500903|Drug|Alisertib|Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg and will be given on an empty stomach, with patients remaining nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose. Each dose will be given by mouth with 8 ounces of water for 7 to 21 consecutive days. A 14-day recovery period will follow each dosing period regardless of its duration.
16319823|NCT00500890|Drug|Carboplatin|350 mg/m^2 by vein, Over 2 Hours x 2 Days
16319824|NCT00500890|Drug|Cyclophosphamide|1 g/m^2 by vein, Over 1 Hour x 2 Days
16319825|NCT00500890|Drug|Etoposide|100 mg/m^2 by vein, Over 1 Hour x 5 Days
16319826|NCT00500890|Drug|Vincristine|1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5
16319827|NCT00500890|Radiation|Radiation Therapy|Radiation treatment over a period of about 6 weeks.
16319828|NCT00500877|Behavioral|Mood Management Phone Counseling for Smoking Cessation|Phone counseling addressed mood management and smoking cessation
16319829|NCT00500864|Drug|Magnesium Sulfate 2 grams|
16319830|NCT00500851|Device|Electromagnetic imaging for jejunal tube placement (CORTRAK)|Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
16319831|NCT00500851|Device|Endoscopy|Endoscopic placement of jejunal feeding tubes
16319832|NCT00500838|Device|Transthoracic Impedance|Impedance measures will be automatically collected via the device
16319833|NCT00500825|Procedure|Measurement of Resting Energy Expenditure|Non-invasive measurement of Resting Energy Expenditure
16319834|NCT00500812|Drug|Cethrin|
16319835|NCT00500786|Biological|CYT006-AngQb|
16319836|NCT00500760|Drug|Cisplatin|Administered intravenously (IV; in a vein)
16319837|NCT00500760|Radiation|Standard Fractionation Radiotherapy|70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
16319838|NCT00500760|Drug|Panitumumab|Administered intravenously
16319839|NCT00500747|Biological|HCV E1E2/MF59|The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.
16319840|NCT00500747|Drug|Placebo|Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
16319841|NCT00500734|Procedure|Blood Sample|One time blood draw of 2 teaspoons.
16319842|NCT00500721|Drug|HCV-796|HCV-796 500mg BID x 14 days
16319843|NCT00500721|Drug|Desipramine|"Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6.
~Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9.
~Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10."
16319844|NCT00500695|Behavioral|Motivational Interviewing|Motivational Interviewing
16319845|NCT00500695|Behavioral|Psychoeducation|Psychoeducation
16319846|NCT00500682|Drug|Placebo|9g /day (3 times a day)
16319847|NCT00500682|Drug|AST-120|9g /day (3 times a day)
16319848|NCT00500669|Drug|Betadine|Topically
16319849|NCT00500656|Drug|Icatibant|Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.
16319850|NCT00500656|Drug|Tranexamic Acid|over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.
16319851|NCT00500656|Drug|Oral Placebo|hard capsule matched to tranexamic acid
16319852|NCT00500656|Drug|S.C. Placebo|solution for injection, matched to icatibant for injection
16319853|NCT00500630|Device|Body fixed 3D sensors|
16319854|NCT00500617|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16319855|NCT00500604|Drug|Irbesartan/hydrochlorothiazide|150/12.5mg tablet and 300/12.5mg tablet
16319856|NCT00500604|Drug|Valsartan/hydrochlorothiazide|80/12.5mg tablet and 160/12.5mg tablet
16319857|NCT00500604|Drug|Hydrochlorothiazide|12.5 mg administered orally, once daily in the morning
16319858|NCT00500591|Behavioral|Questionnaire|Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes.
16319859|NCT00500578|Drug|Ribavirin|Arm 1 = 6 Grams Over 18 hours Every 24 Hours
16319860|NCT00500578|Drug|Ribavirin|Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.
16319861|NCT00500565|Drug|Saline|On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
16319862|NCT00500565|Drug|Bupivicaine|On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.
16319863|NCT00500552|Drug|Perhexiline/Placebo|
16319864|NCT00500539|Drug|omalizumab|The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.
16319865|NCT00500526|Other|Singing practice|
16319866|NCT00500526|Other|Singing classes|
16319867|NCT00500526|Other|Hand craft classes|
16319868|NCT00500513|Procedure|CT Scans|CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
16319869|NCT00500513|Procedure|Implanted markers|Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope
16319870|NCT00500513|Radiation|Radiation Treatment (RT)|Radiotherapy incorporating respiratory treatment delivery
16319871|NCT00500500|Drug|EGb 761® (Tanakan®)|
16319872|NCT00500487|Behavioral|Affect Management|12-session group intervention including affect management training as well as sexual health skills training.
16319873|NCT00500487|Behavioral|HIV Prevention Skills|12-session group intervention including sexual health skills training.
16319874|NCT00500487|Behavioral|General Health Promotion|12-session group intervention including health information on a variety of health topics.
16319875|NCT00500474|Procedure|endolymphatic sac drainage with steroids|
16319876|NCT00500461|Drug|GSK233705|GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
16319877|NCT00500448|Device|Electrical Stimulation|Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks
16319878|NCT00500435|Procedure|Extraperitoneal Laparoscopic Lymphadenectomy|Laparoscope used to find and remove para aortic lymph nodes in abdomen.
16319879|NCT00500422|Drug|Doxil|Starting dose of 20 mg/m^2 IV over 2 hours on Day 1, 21 day cycle
16319880|NCT00500422|Drug|Gemcitabine|500 mg/m^2 IV over 30 minutes on Days 1 and 8, 21 day cycle
16319881|NCT00500422|Drug|Velcade|Starting dose of 0.7 mg/m^2 IV on Days 1 and 8 of first 21 day cycle; increased dose of 1.0 to 1.3 on Days 1, 4, 8, and 11 of subsequent 21 day cycles
16319882|NCT00500409|Drug|Osteoform|Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days
16319883|NCT00500409|Drug|SHELCAL|Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days
16319884|NCT00500396|Procedure|Open-Sky Vitrectomy|Open-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment
16319885|NCT00500370|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
16319886|NCT00500370|Drug|placebo|subcutaneous injection (equivalent volume to active dose), twice a day
16319887|NCT00500357|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose 13vPnC
16319888|NCT00500344|Drug|Lucentis (ranibizumab)|intravitreal injection
16319889|NCT00500331|Drug|GSK189075|Experimental Drug
16319890|NCT00500331|Drug|pioglitazone|Active Control
16319891|NCT00500331|Other|Placebo|Placebo Comparator
16319892|NCT00500318|Drug|Aclidinium Bromide|Aclidinium Bromide, 200μg. Once daily oral inhalation.
16319893|NCT00500318|Drug|Placebo|Dose matched placebo, once daily oral inhalation.
16319894|NCT00500305|Procedure|Withhold standard INDO dose if BNP < 100 pg/ml|
16319895|NCT00500292|Drug|Vandetanib|once daily oral tablet two dose strengths
16319896|NCT00500292|Drug|FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid|intravenous infusion
16319897|NCT00500279|Drug|Celecoxib|
16319898|NCT00500253|Device|exhaled nitric oxide measurement|exhaled nitric oxide measurement
16319899|NCT00500253|Procedure|bronchial hyperresponsiveness with methacholine (PC20M)|bronchial hyperresponsiveness with methacholine (PC20M)
16319900|NCT00500253|Procedure|symptom score diary (according to 2007 GINA guidelines)|symptom score diary (according to 2007 GINA guidelines)
16319901|NCT00500240|Drug|Insulin Glargine|Use of human insulin glargine for slow decrease of blood sugar level over 24 hours.
16319902|NCT00500240|Drug|Insulin Aspart|Use of human insulin aspart for rapid lowering of the blood glucose level over 24 hours.
16319903|NCT00500214|Procedure|elective ilioinguinal nerve excision|
16319904|NCT00500201|Drug|SB- 773812 60 mg|SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
16319905|NCT00500201|Drug|SB- 773812 120 mg|SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
16319906|NCT00500201|Drug|Placebo|Placebo tablets will be administered orally by subjects.
16319907|NCT00500188|Drug|Imatinib Mesylate (Gleevec)|300 mg orally twice daily
16319908|NCT00500175|Device|TempTouchRM|
16319909|NCT00500175|Device|Offloading|
16319910|NCT00500162|Behavioral|Tri-Luma Maintenance regimen|
16319911|NCT00500149|Drug|Vyvanse (lisdexamfetamine dimesylate)|Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day).
16319912|NCT00500149|Drug|Placebo|Placebo
16319913|NCT00500136|Procedure|mortality salience|
16319914|NCT00500123|Procedure|Alpha-1 Antitrypsin Genotype|Home fingerstick testing for alpha-1 antitrypsin genotype
16319915|NCT00500110|Drug|Docetaxel|30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.
16319916|NCT00500110|Drug|Imatinib Mesylate|600 mg by mouth (PO) Daily x 42 Days.
16319917|NCT00500110|Drug|Leuprolide|Hormone injections given every other month or every 3 months, as determined by the doctor.
16319918|NCT00500110|Drug|Goserelin Acetate|Hormone injections given every other month or every 3 months, as determined by the doctor.
16319919|NCT00500097|Device|Digital retina image|
16319920|NCT00500097|Device|direct ophthalmoscopy|
16319921|NCT00500097|Procedure|comprehensive eye exam|
16319922|NCT00500084|Drug|Liprotamase|Administered orally
16319923|NCT00500071|Drug|Vyvanse (lisdexamfetamine dimesylate)|Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.
16319924|NCT00500058|Drug|SB-485232|SB-485232 for injection, 7 mg/vial, will be available as a lyophilized cake. It will be reconstituted with 1.4 mL of water for injection. Each vial of this drug product is a clear, colorless solution containing 5 mg/mL of SB-485232.
16319925|NCT00500058|Drug|Rituximab|Rituximab 375 mg/m^2 will be administered by IV infusion.
16319926|NCT00500045|Drug|nicotinic acid|niacin 1500 mg po qd
16319927|NCT00500032|Procedure|blood draw|Blood draw from subjects previously vaccinated in 6108A1-500 trial
16319928|NCT00500006|Drug|MK0457|"Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour.
~Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour."
16319929|NCT00500006|Drug|dasatinib|Oral dasatinib 70 mg b.i.d. tablets twice daily.
16319930|NCT00499993|Drug|lanreotide (Autogel formulation), duration of treatment 46-48 weeks|
16319931|NCT00499967|Drug|GS-9191 ointment|GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
16320025|NCT00499460|Dietary Supplement|garlic powder tablets|Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet
16320026|NCT00499460|Drug|oxycodone|Single administration of three 5-mg oxycodone tablets or a 15-mg dose
16320027|NCT00499447|Procedure|radiofrequency ablation|
16319932|NCT00499967|Drug|GS-9191|GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
16319933|NCT00499967|Drug|Placebo|Placebo matching GS-9191 ointment
16319934|NCT00499954|Procedure|Microdialysis|
16319935|NCT00499954|Device|Guardian RT|
16319936|NCT00499954|Device|Glucoday S|
16319937|NCT00499928|Drug|SB-751689|
16319938|NCT00499915|Behavioral|Secondhand Smoke Reduction and Smoking Cessation Counseling|A secondhand smoke reduction program, including smoking cessation counseling (if appropriate), and feedback about the children's cotinine levels will be implemented using principles of Motivational Interviewing.
16319939|NCT00499915|Behavioral|Asthma Education|Asthma education will be provided at NICU discharge.
16319940|NCT00499902|Drug|alfimeprase|Alfimeprase will be given as a single bolus of 1mg/2mL, or a split bolus of 5mg/2mL or 10mg/2mL in a three-tier dose escalation format. The 5mg and 10mg doses will be administered as split doses with 1/2 of the total dose given initially and 1/2 of the total dose given 30 minutes after the initial dose.
16319941|NCT00499889|Drug|Imatinib Mesylate|400 mg by mouth twice daily for 9 Days
16319942|NCT00499889|Drug|Fludarabine (Fludara)|40 mg/m^2 by vein daily for 4 Days
16319943|NCT00499889|Drug|Busulfan|130 mg/m^2 by vein daily for 2 Days
16319944|NCT00499889|Drug|Antithymocyte Globulin (ATG)|2.5 mg/kg by vein daily for 3 Days
16319945|NCT00499889|Drug|Tacrolimus|Tacrolimus levels maintained between 5-15 ng/dl, first as continuous IV infusion, and converted to oral every 12 hour dosing as tolerated. Starting day -2 until day 180.
16319946|NCT00499889|Drug|Methotrexate|5 mg/m2 on days 1, 3, 6 and 11.
16319947|NCT00499889|Procedure|Donor lymphocyte infusion (DLI)|Infusion of lymphocytes from the original bone marrow donor by vein if relapse after >4 weeks of imatinib.
16319948|NCT00499889|Procedure|Stem Cell Transplant|Infusion of donor bone marrow or blood stem cells by vein over approximately one hour on day 0.
16319949|NCT00499876|Drug|mefloquine|250mg weekly PO for 6 months
16319950|NCT00499876|Other|placebo|1 tablet weekly PO for 6 months
16319951|NCT00499863|Drug|methylphenidate transdermal system|dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
16319952|NCT00499863|Drug|Placebo|Placebo patch
16319953|NCT00499850|Drug|ZD6474 (vandetanib)|once daily oral dose
16319954|NCT00499850|Drug|5-Fluorouracil|intravenous infusion
16319955|NCT00499850|Drug|Leucovorin|intravenous infusion
16319956|NCT00499850|Drug|Oxaliplatin|intravenous infusion
16319957|NCT00499837|Drug|Aerosolized, human, plasma-derived Alpha-1 Antitrypsin|
16319958|NCT00500266|Biological|13-valent Pneumococcal Conjugate Vaccine (13vPnC)|
16319959|NCT00499824|Behavioral|Education of general practitioners on the IDF-WPR guidelines|"The intervention will comprise an educational program on the guidelines for GPs, and will be carried out by the national coordinating centre in each country, based on a template provided by the international coordinating centre (International Diabetes Institute, Australia). This will involve:
~an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a diabetes passport to be held by the patient."
16319960|NCT00499811|Drug|vorinostat|Given orally
16319961|NCT00499811|Other|pharmacological study|Correlative studies
16319962|NCT00499759|Behavioral|Resting vitals|The fitness assessments will include the assessment of resting vitals including, blood pressure, heart rate, and hemoglobin saturation (pulse oximeter).
16319963|NCT00499759|Behavioral|Body Composition|Body composition and body circumference measurements (anthropometry) will be the only assessments performed multiple times during the study to monitor possible changes in the body composition and swelling of the patients. Body composition analyses will be performed via skinfold measurements following generalized three-site skinfold equations for male and females as recommended by the ACSM, 2005 and via the utilization of a bioelectrical impedance body fat analyzer device.
16319964|NCT00499759|Behavioral|Timed Get-up and Go test (TGUG).|"The functional mobility of the subjects that will participate in the study will be assessed through the Timed Get-up and Go test (TGUG). The administration of the TGUG includes measuring a distance of 3 meters from the legs of a straight-backed armchair with a seat height of approximately 46 centimeters. The subject will be asked to sit with the back against the chair with the arms on the arm rests. When instructed to begin the test (on the command Go), the subject will have to stand upright then walk at a normal walking pace toward the 3 meters mark placed on the ground, turn around, return to the chair, and sit down. The stopwatch was started on the word Go and stopped when the subject gets back to starting position."
16319965|NCT00499759|Behavioral|Cardiorespiratory assessment|The cardiorespiratory assessment will be performed on a recumbent cycle ergometer. Subjects will be asked to cycle at a target submaximal intensity of 60 % of their percentage of heart rate range until a RPE (Rate of Perceived Exertion) of 7 is reached on the modified Borg Scale or when the subject requests termination. The Borg modified RPE scale is a scale ranging from 0 to 11 where 0 means no exertion at all and 11 equals to an exertion of absolute maximum. The total time cycling and heart rate (HR) at the end of the test will be recorded immediately after the test is completed.
16319966|NCT00499759|Behavioral|Handgrip evaluation|Handgrip strength will be tested using a handgrip dynamometer. Subjects will be asked to stand and hold the handgrip dynamometer in one hand lined with the forearm that will be placed beside the body. Maximum grip strength is then determined without swinging the arm and by squeezing the handgrip dynamometer as hard as possible using one brief maximal contraction with no extraneous body movement. The test will be administered three times for each hand with a one-minute rest in between trials. The best score within the three trials for each arm will be the one that will be used for analysis.
16320028|NCT00499447|Radiation|radiation therapy|
16320029|NCT00499421|Procedure|Computed Tomography (CT) Scan|CT scan of the prostate three times a week, just before the delivery of radiation.
16320103|NCT00499070|Genetic|polymerase chain reaction|
16319967|NCT00499759|Behavioral|Dynamic muscular endurance|Subjects will be asked to squat to a 75 degree knee angle with moderate speed, pressing back against the ball at all times. This is repeated as many repetitions as it takes for the subject to report an RPE of 7 or wishes to stop. The second test is the biceps curl exercise. The biceps curls exercise test will follow a protocol developed at the Rocky Mountain Cancer Rehabilitation Institute (RMCRI), Greeley, Colorado. The protocol involves the administration of the exercise biceps curls, done with dumbbells. Subjects will be asked to perform as many repetitions as possible during an alternated biceps curl exercise using a percentage of their body weight as resistance.
16319968|NCT00499746|Drug|tramadol|oral dose, once per day
16319969|NCT00499746|Drug|placebo|oral dose, once per day
16319970|NCT00499746|Drug|Hydromorphone|oral dose, once per day
16319971|NCT00499746|Drug|Methylphenidate|oral dose, once per day
16319972|NCT00499733|Drug|cyclophosphamide|500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
16319973|NCT00499733|Device|Cryoablation|Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
16319974|NCT00499720|Drug|Aztreonam Lysine for Inhalation|75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
16319975|NCT00499707|Drug|rosiglitazone maleate/metformin hydrochloride|rosiglitazone maleate/metformin hydrochloride
16319976|NCT00499694|Biological|bevacizumab|10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
16319977|NCT00499694|Drug|satraplatin|80 mg/m(2), Orally, Days 1-5, every 35 days
16319978|NCT00499681|Drug|lapatinib ditosylate|Given once daily, 1500mg, for 2 weeks; Given once daily, 1500mg, for 14 weeks in Arm II
16319979|NCT00499681|Drug|letrozole|Given once daily, 2.5mg, for 2 weeks; Given once daily, 2.5mg, for 14 weeks
16319980|NCT00499681|Other|placebo|Given once daily for 2 weeks
16319981|NCT00499668|Drug|aprepitant|125 mg orally for 7 days
16319982|NCT00499668|Drug|ondansetron hydrochloride|24 mg orally for 7 days
16319983|NCT00499655|Drug|erlotinib hydrochloride|Given orally
16319984|NCT00499655|Drug|celecoxib|Given orally
16319985|NCT00499655|Other|placebo|Given orally
16319986|NCT00499655|Other|laboratory biomarker analysis|Correlative studies
16319987|NCT00499655|Other|immunohistochemistry staining method|Correlative studies
16319988|NCT00499655|Genetic|fluorescence in situ hybridization|Correlative studies
16319989|NCT00499655|Genetic|mutation analysis|Correlative studies
16319990|NCT00499655|Genetic|protein expression analysis|Correlative studies
16319991|NCT00499655|Genetic|gene expression analysis|Correlative studies
16319992|NCT00499642|Drug|Lecozotan SR|
16319993|NCT00499642|Drug|Moxifloxacin|
16319994|NCT00499629|Drug|FXR 450|capsule, single oral doses from 10 mg to 450 mg
16319995|NCT00499629|Drug|placebo|capsule similar to active drug
16319996|NCT00499616|Drug|carboplatin|Given IV
16319997|NCT00499616|Drug|cyclophosphamide|Given IV
16319998|NCT00499616|Drug|doxorubicin hydrochloride|Given IV
16319999|NCT00499616|Drug|etoposide|Given orally
16320000|NCT00499616|Drug|topotecan hydrochloride|Given IV
16320001|NCT00499616|Drug|Isotretinoin|Given orally
16320002|NCT00499616|Procedure|Surgery|With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.
16320003|NCT00499616|Drug|Filgrastim|Administered subcutaneously or by IV beginning 24-48 hrs after the last dose of chemotherapy & continuing daily until the ANC is greater than or equal to 1500 following the myelosuppressive nadir . Supportive care given to stimulate neutrophil recovery following chemotherapy and to shorten the duration of chemotherapy-induced neutropenia. On ANBL0531 the use of filgrastim was required for patients less than 60 days of age and was optional for other patients.
16320004|NCT00499603|Drug|Paclitaxel|80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
16320005|NCT00499603|Drug|5-Fluorouracil|500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
16320006|NCT00499603|Drug|Epirubicin|100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
16320007|NCT00499603|Drug|Cyclophosphamide|500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
16320008|NCT00499603|Drug|RAD001|30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.
16320009|NCT00499590|Drug|bevasiranib|Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
16320010|NCT00499590|Drug|ranibizumab|Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
16320011|NCT00499577|Biological|CMV pp65 peptide|Given intramuscularly
16320012|NCT00499577|Biological|hTERT I540/R572Y/D988Y multipeptide vaccine|Given subcutaneously
16320013|NCT00499577|Biological|pneumococcal polyvalent vaccine|Given intramuscularly
16320014|NCT00499577|Biological|survivin Sur1M2 peptide vaccine|Given subcutaneously
16320015|NCT00499551|Device|Iontophoresis second generation Eyegate II device|
16320016|NCT00499538|Drug|SKI-606|
16320017|NCT00499525|Drug|paclitaxel|given IV
16320018|NCT00499525|Drug|sorafenib tosylate|given orallly
16320019|NCT00499525|Other|placebo|given orally
16320020|NCT00499512|Behavioral|Questionnaire|Questionnaires that ask questions about religion, spirituality, and decisions about treatment at three points (at time of diagnosis, end of primary chemotherapy, and one year later).
16320021|NCT00499499|Drug|E7107|E7107 will be administered as an intravenous infusion over 30 minutes at a starting dose of 0.6 mg/m^2 to the first cohort of patients. The same dose will be given on Days 1 and 8 of a 21-day cycle. Dose escalation will not occur until the maximum tolerated dose is reached. The selection of subsequent dose levels will be performed according to an accelerated design.
16320022|NCT00499486|Drug|sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
16320023|NCT00499473|Drug|sunitinib malate|Given orally
16320024|NCT00499473|Other|pharmacological study|Correlative studies
16320030|NCT00499408|Dietary Supplement|Vitamin D|Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)
16320031|NCT00499408|Dietary Supplement|soy|Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
16320032|NCT00499395|Procedure|positron emission tomography|All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. When evaluating patients with liver metastases, we routinely obtain a dedicated liver PET study (Liver View) after the whole body PET. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA
16320033|NCT00499395|Procedure|radiofrequency ablation|All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA
16320034|NCT00499382|Procedure|Nuclear Medicine Cardiac Scan|Scan lasting 30 minutes while being hooked up to a heart monitor that takes pictures every time your heart beats.
16320035|NCT00499382|Procedure|PET/CT Cardiac Scan|Scan lasting 10-15 minutes and performed after the normally scheduled PET/CT scan.
16320036|NCT00499369|Drug|irinotecan hydrochloride|Given IV
16320037|NCT00499369|Drug|leucovorin calcium|Given IV
16320038|NCT00499369|Drug|fluorouracil|Given IV
16320039|NCT00499369|Biological|cetuximab|Given IV
16320040|NCT00499369|Biological|bevacizumab|Given IV
16320041|NCT00499356|Device|pressure reducing insole|
16320042|NCT00499356|Device|GlideSoft®|
16320043|NCT00499343|Drug|Etoposide|150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.
16320044|NCT00499343|Drug|G-CSF|Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
16320045|NCT00499343|Drug|GM-CSF|250 mcg/m^2 injection given every evening till the completion of apheresis.
16320046|NCT00499343|Drug|Isophosphamide|10 g/m^2 given intravenously continuous infusion over 72 hours.
16320047|NCT00499343|Drug|Rituximab|Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.
16320048|NCT00499343|Procedure|Apheresis|Peripheral blood stem cell collection.
16320049|NCT00499330|Procedure|lobectomy|
16320050|NCT00499330|Procedure|segmentectomy or wedge resection|
16320051|NCT00499291|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16320052|NCT00499291|Procedure|gene expression analysis|
16320053|NCT00499291|Procedure|laboratory biomarker analysis|
16320054|NCT00499291|Procedure|pharmacological study|
16320055|NCT00499291|Procedure|polymerase chain reaction|
16320056|NCT00499278|Behavioral|Rehabilitation after joint replacement surgery|
16320057|NCT00499265|Drug|gemcitabine hydrochloride|1000 mg/m2 as 30 min i.v. infusion once weekly for 7/8 weeks and then every 3/4 weeks
16320058|NCT00499265|Drug|Serine Proteinase Inhibitor WX-671|oral, daily
16320059|NCT00499265|Drug|Serine Proteinase Inhibitor WX-671|oral, daily
16320060|NCT00499252|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|
16320061|NCT00499239|Drug|GS-9219|"GS-9219 Injection is a clear, and colorless to slightly yellow aqueous solution containing 4 mg/mL of GS 9219.
~GS 9219 will be administered via IV infusion over 30 minutes in 100 mL of normal saline solution, every 21 days."
16320062|NCT00499213|Procedure|Home Care Assisted Peritoneal Dialysis|
16320063|NCT00499200|Drug|SRA-444|
16320064|NCT00499187|Procedure|Blood Draws|A single whole blood sample was collected for genomic analysis.
16320065|NCT00499174|Procedure|conventional surgery|Radical prostatectomy
16320066|NCT00499174|Radiation|brachytherapy|high dose rate temporary seed implant; permanent seed implant.
16320067|NCT00499174|Radiation|external beam radiation therapy|3D conformal radiation therapy; intensity modulated radiation therapy.
16320068|NCT00499174|Procedure|Biopsies|Periodic repeat biopsies
16320069|NCT00499161|Behavioral|New model of nursing care|
16320070|NCT00499148|Other|herbal extract; root of woody shrub grown in India/Sri-Lanka|
16320071|NCT00499135|Other|Computed Tomography|Correlative studies
16320072|NCT00499135|Other|Fluorothymidine F-18|Correlative studies
16320073|NCT00499135|Other|Laboratory Biomarker Analysis|Correlative studies
16320074|NCT00499135|Other|Pharmacological Study|Correlative studies
16320075|NCT00499135|Other|Positron Emission Tomography|Correlative studies
16320076|NCT00499135|Drug|Sunitinib Malate|Given PO
16320077|NCT00499122|Drug|Cyclophosphamide|
16320078|NCT00499122|Drug|Docetaxel|
16320079|NCT00499122|Drug|Doxorubicin|
16320080|NCT00499122|Drug|NOV 002|
16320081|NCT00499109|Drug|Docetaxel|"GD Group: 40 mg/m^2 on days 1 and 8, every 21 days
~DCb Group: 75 mg/m^2 on day 1
~DV Group: 50 mg/m^2 on days 1 and 15, every 28 days"
16320082|NCT00499109|Drug|Vinorelbine|DV Group: 35 mg/m^2 on days 1 and 15
16320083|NCT00499109|Drug|Carboplatin|"GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days
~DCb Group: AUC 6 on day 1, every 21 days
~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."
16320084|NCT00499109|Drug|Gemcitabine|"GCb Group: 1,250 mg/m^2 on days 1 and 8
~GD Group: 1,250 mg/m^2 on days 1 and 8
~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."
16320085|NCT00499096|Behavioral|Chronic care model for Bipolar Disorder|The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.
16320086|NCT00499083|Biological|therapeutic autologous dendritic cells|injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments. If, after a cycle(s) of chemotherapy, no tumor can be localized by ultrasound, the DCs will be injected where the tumor bed was localized by the clip or marker.
16320087|NCT00499083|Drug|aromatase inhibition therapy|Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
16320088|NCT00499083|Drug|cyclophosphamide|600 mg/m2 IV day 1 every 2 weeks for 4 cycles
16320089|NCT00499083|Drug|doxorubicin hydrochloride|60 mg/m2 IV day 1 every 2 weeks for 4 cycles
16320090|NCT00499083|Drug|paclitaxel|175 mg/m2 intravenously (IV) over at least 3 hours day 1 every 2 weeks for 4 cycles.
16320091|NCT00499083|Drug|tamoxifen citrate|Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
16320092|NCT00499083|Genetic|gene expression analysis|IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
16320093|NCT00499083|Genetic|protein expression analysis|Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration.
16320094|NCT00499083|Genetic|reverse transcriptase-polymerase chain reaction|delta Ct (quantitative real time- reverse transcription-polymerase chain reaction (qRT-PCR)) of COX-2 and VEGF will be divided into the upper or lower median and Fisher Exact test used to assess the difference in response.
16320095|NCT00499083|Other|immunoenzyme technique|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
16320096|NCT00499083|Other|immunohistochemistry staining method|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
16320097|NCT00499083|Other|laboratory biomarker analysis|"Estrogen and progesterone receptor, Her2/neu testing: Tumor biopsy material (preferably the initial diagnostic biopsy if tissue is available) will be examined by Immunohistochemistry (IHC) with appropriate controls for estrogen, progesterone receptors and Her2/neu. If the IHC is 2+ or in the indeterminate range, further testing of over-expression of Her2/neu by fluorescent in situ hybridization (FISH) will be done . If this has already been done and reported by the referring hospital, it will not be repeated. These tests are standard of care.
~CEA and Survivin testing: IHC for CEA and Survivin with appropriate controls will be done on the tumor biopsy material (preferably from the initial diagnostic biopsy).
~COX-2 and VEGF A , T cell and Dendritic Cells: Tumor biopsymaterial (preferably from the initial diagnostic biopsy) will be stained by IHC with appropriate controls for COX-2, VEGF A, T cell and Dendritic Cell infiltration."
16320098|NCT00499083|Procedure|adjuvant therapy|Hormone manipulation Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor (AI) or those drugs in sequence as determined by the treating oncologist. Hormone therapy will be given for at least 5 years.
16320099|NCT00499083|Procedure|biopsy|Two tumor biopsies will be performed. The first tumor biopsy will be performed before apheresis for diagnostic purposes, and again after completion of the first four chemotherapy treatments. Patients will undergo local anesthesia with lidocaine and 1% epinephrine followed by 1-2 core biopsies of the breast primary and/or palpable axillary node with a 14 gauge, 16 cm. Bard needle or other similar needle. The procedure may be done under ultrasound guidance. If a metal clip or marker has not been previously placed in the tumor, it will be placed before treatment.
16320100|NCT00499083|Procedure|conventional surgery|Definitive breast surgery Surgery will occur two to four weeks after the last course of chemotherapy. Modified radical mastectomy or lumpectomy and standard axillary dissection could be performed and the specific procedure will be decided by the patient and physician team. If a sentinel node dissection was done prior to chemotherapy and was negative, no further node dissection is necessary. A standard node dissection will be necessary if no node assessment was done prior to chemotherapy or if the pre- chemotherapy sentinel node was positive.
16320101|NCT00499083|Procedure|neoadjuvant therapy|Chemotherapy: Paclitaxel (T) 175 mg/m2 intravenously (IV) over at least 3 hours day 1. Repeat every 2 weeks for 4 cycles. IT DCs will be injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
16320102|NCT00499083|Radiation|radiation therapy|Radiation therapy Radiation is started two to four weeks after surgery for all patients receiving lumpectomy and those patients after mastectomy that the physician feels chest wall radiation is warranted (example: T3 or T4 breast lesion, four or more axillary nodes etc.). The exact doses and methods of administration will be determined by the treating radiation therapist, but should be standard breast radiotherapy and not partial breast or investigational methods.
16320104|NCT00499070|Other|flow cytometry|For analyzing GPI deficient clones full blood will be analyzed by phenotyping using flowcytometry. For that purpose CD14, CD16 and CD24 expression will be evaluated in CD45 positive cells. Erythroid cells will be evaluated for CD55 and CD59 expression searching for clear populations with a lack of GPI-linked molecules. In addition, immunophenotyping using flowcytometry will be performed to evaluate which differentiation stages of the major hematopoietic lineages in BM and PB are associated with TCRVβ repertoire skewing. Comparison between BM and PB will identify which is the optimal compartment to analyze the responsible hematopoietic clones.
16320105|NCT00499070|Other|immunologic technique|
16320106|NCT00499070|Procedure|biopsy|
16320107|NCT00499057|Radiation|interstitial high dose-rate brachytherapy, PBI|Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.
16320108|NCT00499044|Other|CDR Computerized Cognitive Assessment System|Cognitive Drug Research Computerized Cognitive Assessment System consists of performance tasks that measure reaction time, numeric and spatial working memory, word and picture recall and recognition, and episodic secondary memory. CDR is a single, unified battery that can be stored and administered using a laptop computer.
16320109|NCT00499044|Other|MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery measures functioning across various cognitive domains, such as attention, working memory (verbal and nonverbal), learning (verbal and visual), reasoning and problem solving, and social cognition. Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes.
16320110|NCT00499031|Biological|Cetuximab|Given IV
16320111|NCT00499018|Drug|Rituximab|375 mg/m2 day 1
16320112|NCT00499018|Drug|Ciclofosfamide|1200 mg/m2 day 1
16320113|NCT00499018|Drug|Doxorubicina|70 mg/m2 day 1
16320114|NCT00499018|Drug|Vincristina|1,4 mg/m2 (max 2 mg) day 1
16320115|NCT00499018|Drug|Prednisone|100 mg day g 1-5
16320116|NCT00499018|Drug|Pegfilgrastim|6 mg day +1
16320117|NCT00499018|Drug|Mitoxantrone|8 mg/m2/days 1-3
16320118|NCT00499018|Drug|ARA-C|2000 mg/m2/12h day 1 - 3
16320119|NCT00499018|Drug|Lenograstim|5 μg/Kg/days +2
16320120|NCT00499018|Drug|BCNU|300 mg/m2 day -7
16320121|NCT00499018|Drug|ARA-C|200 mg/m2/12 days -6,-5,-4,-3
16320122|NCT00499018|Drug|VP-16|100 mg/m2/12h days -6,-5,-4,-3
16320123|NCT00499018|Procedure|ASCT|PBSC Reinfusion
16320124|NCT00499018|Drug|Ciclofosfamide|750 mg/m2 day 1
16320125|NCT00499018|Drug|Doxorubicina|50 mg/m2 day 1
16320126|NCT00499018|Drug|Vincristina|1,4 mg/m2 (max 2 mg) day 1
16320127|NCT00499005|Drug|Syntommetrine and Carbetocin|Syntommetrine 1ml and Carbetocin 100microgram
16320128|NCT00499005|Drug|Syntommetrine and Carbetocin|Syntommetrine 1ml and Carbetocin 100micgrams
16320129|NCT00498992|Dietary Supplement|collagen/aloe vera/vitamin E/lidocaine topical hydrogel|
16320130|NCT00498979|Biological|recombinant interferon alfa-2b|recombinant interferon alfa-2b
16320131|NCT00498979|Drug|cisplatin|recombinant interferon alfa-2b
16320132|NCT00498979|Drug|sodium stibogluconate|sodium stibogluconate
16320133|NCT00498979|Drug|dacarbazine|dacarbazine
16320134|NCT00498979|Drug|vinblastine|vinblastine
16320135|NCT00498966|Drug|Perifosine|"Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient.
~Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food."
16320136|NCT00498953|Drug|carboplatin|
16320137|NCT00498953|Drug|cisplatin|
16320138|NCT00498953|Drug|docetaxel|
16320139|NCT00498953|Drug|fluorouracil|
16320140|NCT00498953|Drug|lapatinib ditosylate|
16320141|NCT00498953|Genetic|cytogenetic analysis|
16320142|NCT00498953|Genetic|fluorescence in situ hybridization|
16320143|NCT00498953|Genetic|in situ hybridization|
16320144|NCT00498953|Genetic|polymerase chain reaction|
16320145|NCT00498953|Genetic|reverse transcriptase-polymerase chain reaction|
16320146|NCT00498953|Other|immunohistochemistry staining method|
16320147|NCT00498953|Other|laboratory biomarker analysis|
16320148|NCT00498953|Procedure|conventional surgery|
16320149|NCT00498953|Procedure|neoadjuvant therapy|
16320150|NCT00498953|Radiation|fludeoxyglucose F 18|
16320151|NCT00498953|Radiation|radiation therapy|
16320152|NCT00498940|Device|Optimization Testing|Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.
16320153|NCT00498940|Device|Temporary Biventricular Pacing|Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate.
16320154|NCT00498927|Drug|temozolomide|
16320155|NCT00498927|Genetic|protein expression analysis|
16320156|NCT00498927|Genetic|reverse transcriptase-polymerase chain reaction|
16320157|NCT00498927|Other|diagnostic laboratory biomarker analysis|
16320158|NCT00498927|Other|immunoenzyme technique|
16320159|NCT00498914|Drug|YM155|Continuous IV infusion
16320160|NCT00498901|Drug|goserelin|
16320161|NCT00498901|Drug|letrozole|
16320162|NCT00498901|Drug|leuprolide acetate|
16320163|NCT00498901|Procedure|conventional surgery|
16320164|NCT00498888|Procedure|tolterodine|Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
16320165|NCT00498888|Procedure|bladder training|Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
16320166|NCT00498888|Procedure|pelvic floor muscle training|Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
16320167|NCT00498888|Procedure|pelvic floor rehabilitation|The Pelvic floor rehabilitation protocol based on bladder training protocol and PFMT and lifestyle advice and information about good bladder and bowel habits. Four visits in 3 months was made with pelvic floor physical therapist, who is trained in the procedure.
16320168|NCT00498875|Behavioral|Questionnaire|Questionnaire regarding mood, coping with cancer, how closely you follow your treatment schedule, your thoughts, your demographic information (such as age and race), and your medical history. If the answers to your questionnaire indicate that you may be depressed, you will be offered the intervention portion of the study.
16320169|NCT00498875|Behavioral|Depression Intervention|"Sessions given over 7 weeks and each lasting 30-45 minutes, that use cognitive-behavioral techniques."
16320170|NCT00498849|Device|CPAP|
16320171|NCT00498836|Drug|CP-4055|CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion
16320172|NCT00498836|Drug|Sorafenib (Nexavar)|Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing
16320173|NCT00498810|Procedure|complete repair|
16320174|NCT00498810|Procedure|partial repair of the abdominal wall|
16320175|NCT00498797|Drug|Zactima (vandetanib)|
16320176|NCT00498797|Drug|Docetaxel|
16320177|NCT00498797|Drug|Prednisolone|
16320178|NCT00498784|Drug|Mirena|Mirena 52mg during 1 year
16320179|NCT00498771|Behavioral|Aquatic Exercise arm|Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
16320180|NCT00498758|Device|APOS System - biomechanical wedge shoe|
16320181|NCT00498745|Drug|neratinib|HKI-272
16320182|NCT00498732|Device|CPAP|CPAP treatment for 4 weeks
16320183|NCT00498719|Behavioral|Cognitive Training Program|Cognitive training sessions over a 4 to 6 month training period, each lasting about 2 hours.
16320184|NCT00498719|Other|Control Group|Standard educational support.
16320185|NCT00498706|Behavioral|Telephone-administered cognitive behavioral therapy (T-CBT)|Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
16320186|NCT00498706|Behavioral|Face-to-face administered CBT (FtF-CBT)|Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
16320187|NCT00498680|Drug|Sildenafil, Vardenafil|Sildenafil 100mg, vardenafil 20mg, combination of both half dosage.
16320188|NCT00498680|Drug|Sildenafil|100mg
16320189|NCT00498680|Drug|Vardenafil|20mg
16320190|NCT00498680|Drug|Sildenafil & Vardenafil|50mg & 10 mg
16320191|NCT00498654|Biological|Ty800 (Salmonella typhi) Oral Vaccine|
16320192|NCT00498641|Procedure|computer program and patching|
16320193|NCT00498628|Drug|Quetiapine fumarate|Quetiapine fumarate- taken daily, for 12 weeks
16320194|NCT00498628|Other|Placebo|Placebo
16320195|NCT00498615|Drug|Fasudil|Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible sequences. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.
16320196|NCT00498602|Biological|ACC-001 + QS-21|IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
16320197|NCT00498602|Biological|QS-21|IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
16320198|NCT00498602|Other|Diluent: Phosphate Buffered Saline|IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
16320199|NCT00498602|Biological|ACC-001|IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
16320200|NCT00498589|Drug|methotrexate|25 mg per week IM or SC during 24 weeks
16320201|NCT00498589|Drug|placebo|one intramuscular injection per week
16320202|NCT00498563|Procedure|altitude exposure in hypobaric chamber|
16320203|NCT00498550|Drug|Clozapine|Clozapine up to 550mg per day
16320204|NCT00498550|Drug|Treatment as usual|Remain on pre-study antipsychotic treatment
16320205|NCT00498537|Drug|spironolactone|
16320206|NCT00498524|Device|ICD|Received an ICD
16320207|NCT00498524|Device|ICD|Have not received an ICD
16320208|NCT00498511|Procedure|upper gastrointestinal endoscopy, colonoscopy|
16320209|NCT00498485|Drug|Placebo|Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
16320210|NCT00498485|Drug|Sodium Oxybate|Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
16320211|NCT00498472|Procedure|Pre-discharge NT-ProBNP based treatment|"Discharge date, treatment and follow-up based also on the knowledge of NT-ProBNP levels measured at 2-3 days before discharge.
~Discharge may be postponed and medical treatment may be changed when NT-ProBNP is >3000 pg/ml. Changes in medical treatment will include the following: increase in the diuretic dose, association of a different diuretic; combination of digoxin therapy; increase in the dose of the renin-angiotensin inhibitor; association of an ARB; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy."
16320212|NCT00498459|Behavioral|Physical activity|Physical promotion according to socio-ecological model Limitation of sedentary behaviour
16320213|NCT00498433|Drug|Aliskiren|300 mg tablet once daily
16320214|NCT00498433|Drug|Amlodipine|5 mg capsule once daily
16320215|NCT00498433|Drug|Placebo of Aliskiren|Matching placebo of aliskiren 300 mg tablet
16320216|NCT00498433|Drug|Placebo of amlodipine|Matching placebo of amlodipine 5 mg capsule
16320217|NCT00498407|Drug|CP-4055|CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion
16320218|NCT00498394|Behavioral|Clinical diet trial|
16320219|NCT00498381|Device|CPAP|
16320220|NCT00498368|Drug|Intravenous Rituximab|"Rituximab Therapy [27 Patients]
~Rituximab 1 gm IV on Treatment Day 1
~Rituximab 1 gm IV on Treatment Day 15
~Rituximab 1 gm IV on Treatment Day 168
~Rituximab 1 gm IV on Treatment Day 182"
16320221|NCT00498368|Drug|ACE/ARB|ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB
16320222|NCT00498368|Dietary Supplement|Omega-3 Fatty Acid Fish Oil Supplement|Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day
16320223|NCT00498355|Drug|Ranibizumab|0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
16320224|NCT00498342|Drug|N-acetylcysteine|
16320225|NCT00498316|Procedure|Cord Blood Infusion|Cord blood transplantation performed on day 0.
16320226|NCT00498316|Drug|Busulfan|32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
16320227|NCT00498316|Drug|Fludarabine|"10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
~40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
~40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
16320228|NCT00498316|Drug|Rituximab|375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
16320229|NCT00498316|Other|ATG|"1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
~1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
16320230|NCT00498316|Drug|Cyclophosphamide|50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are > 55 and < 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
16320231|NCT00498316|Drug|Clofarabine|30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are >1 and < 55 years old. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
16320232|NCT00498316|Radiation|Total Body Irradiation (TBI)|200 cGy at 25 cGy/minute delivered on Day -3.
16320233|NCT00498316|Drug|Melphalan|140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are >1 and < 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
16320234|NCT00498316|Drug|Tacrolimus|0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.
16320235|NCT00498316|Drug|Mycophenolate Mofetil|1 gram by vein twice a day Days -3 through Day 100.
16320236|NCT00498316|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is > 2.5 x 109/L.
16320237|NCT00498303|Biological|trivalent split influenza vaccine|
16320238|NCT00498290|Procedure|enhanced recovery after surgery (ERAS) protocol|An integrated protocol aims to allow patients to recover more quickly from major surgery, avoid medium-term sequelae of conventional postoperative care (e.g. decline in nutritional status and fatigue) and reduce health care costs by reducing hospital stay
16320239|NCT00498290|Procedure|control|normal recovery protocol as usually
16320240|NCT00498277|Procedure|Magnetic Resonance Imaging|One MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion.
16320241|NCT00498264|Behavioral|walking program, resistance muscular exercise|
16320242|NCT00498251|Drug|inhalation of salbutamol (5 mg)|
16320243|NCT00498251|Drug|ipratropium|
16320244|NCT00498238|Drug|Levothyroxine|
16320245|NCT00498225|Drug|Gemcitabine plus TS-1|Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
16320246|NCT00498225|Drug|TS-1|TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
16320247|NCT00498225|Drug|Gemcitabine|Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
16320248|NCT00498212|Biological|1018 ISS-HBsAg-Single|Intramuscular (IM) injection at Day 0, Week 4 and Week 24
16320249|NCT00498212|Biological|1018 ISS-HBsAg-Double|Intramuscular (IM) injection at Day 0, Week 4 and Week 24
16320250|NCT00498199|Procedure|visual tests|
16320251|NCT00498186|Drug|Rotigotine|"Rotigotine transdermal patches once daily:
~2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)"
16320252|NCT00498173|Drug|Atomoxetine|Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.
16320253|NCT00498173|Drug|Placebo|Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.
16320254|NCT00498160|Biological|Enriched Hematopoietic Stem Cell Infusion|Enriched Hematopoietic Stem Cell Infusion
16320255|NCT00498147|Other|ADEC Program|Interventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed.
16320256|NCT00498134|Drug|Triple therapy for H. pylori infection|
16320257|NCT00498134|Drug|Cox-2 inhibitor|
16320258|NCT00498121|Device|PROCALCITONIN LEVEL|measuring PROCALCITONIN LEVEL
16320259|NCT00498108|Drug|Rotigotine|
16320260|NCT00498095|Procedure|Renal biopsy|
16320261|NCT00498069|Device|Harvest Smartprep2 BMAC System|injection of 40cc bmac
16320262|NCT00498069|Device|SmartPReP2 BMAC System|Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
16320263|NCT00498069|Biological|placebo|injection of placebo into ischemic tissue of the lower extremity
16320264|NCT00498056|Biological|VRC-HIVDNA016-00-VP|DNA vaccine administered intramuscularly
16320265|NCT00498056|Biological|VRC-HIVADV014-00-VP|Adenovirus vaccine administered intramuscularly
16320266|NCT00498056|Biological|VRC-HIVDNA016-00-VP placebo|DNA vaccine placebo administered intramuscularly
16320267|NCT00498056|Biological|VRC-HIVADV014-00-VP placebo|Adenovirus vaccine placebo administered intramuscularly
16320268|NCT00498043|Drug|R-CHOP14 induction regimen|R-CHOP14 induction regimen
16320269|NCT00498043|Drug|R-ACVBP14 induction regimen|R-ACVBP14 induction regimen
16320270|NCT00498004|Drug|Quetiapine, Risperidone|The dose of quetiapine will be titrated over 4 days to 300mg/day (50mg at day 1, 100mg at day 2, 200mg at day 3 and 300mg at day 4) and thereafter flexible dose will be administered depending on the clinical state. The dose of risperidone will be titrated as following 2mg at day 1 and 4mg at day 4 and thereafter flexible dose will be administered depending on the clinical state. The dosage of drugs should be 400-800mg/day of quetiapine and 4-6mg/day of risperidone between 6 and 8 weeks of trial.
16320271|NCT00497991|Drug|AZD1152|
16320272|NCT00497978|Dietary Supplement|taurine|6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day
16320273|NCT00497978|Dietary Supplement|placebo|a similar amount of placebo will be given each day in capsules, starting the day of admission till the sixth postoperative day
16320274|NCT00497965|Procedure|Chiropractic Manipulation|
16320275|NCT00497965|Behavioral|Balance Exercises|
16320276|NCT00497952|Biological|hematopoetic stem cell infusion|Enriched hematopoietic stem cell infusion
16320277|NCT00497939|Drug|Saw palmetto and sanmiaoshan capsule|
16320278|NCT00497926|Biological|Enriched Hematopoietic Stem Cell Infusion|Enriched Hematopoietic Stem Cell Infusion
16320279|NCT00497913|Drug|NaCl 0.9%|
16320280|NCT00497913|Drug|Botulinum Toxin A|
16320281|NCT00497900|Drug|Vitamin D|Daily vitamin D (cholecalciferol) tablets and rocaltrol
16320282|NCT00497874|Behavioral|Computer-tailored intervention|Stage-based manual and three computer-tailored reports
16320283|NCT00497861|Procedure|Activator Methods Chiropractic Technique|
16320284|NCT00497848|Behavioral|motivational interviewing|"An individual intervention building on the Motivational Interviewing by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy"
16320285|NCT00497848|Other|The System-Orientated Intervention|"Principles in this intervention come from Clinical Risk Managing and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on."
16320286|NCT00497822|Procedure|Aerobic exercise training|
16320287|NCT00497809|Drug|AVI-014 versus Filgrastim|3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
16320288|NCT00497796|Drug|maribavir|100mg twice a day for 14 weeks.
16320289|NCT00497796|Drug|ganciclovir|1000mg three times per day for 14 weeks.
16320290|NCT00497783|Drug|Lactoserum|
16320291|NCT00497770|Drug|Pemetrexed|Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
16320292|NCT00497757|Biological|enriched hematopoetic stem cell infusion|Enriched Hematopoetic Stem Cell Infusion
16320293|NCT00497744|Drug|Intraperitoneal Cefepime|
16320294|NCT00497731|Drug|AZD1152|2-hour continuous intravenous infusion
16320295|NCT00497718|Procedure|Chiropractic Manipulation|
16320296|NCT00497692|Drug|Lactoserum|
16320297|NCT00497679|Drug|AZD1152|7-day continuous intravenous infusion
16320298|NCT00497666|Drug|Rosiglitasone (retrospective observation)|
16320299|NCT00497653|Drug|DCI|D-chiro-inositol 1200mg twicely daily for 6 weeks
16320300|NCT00497653|Drug|Placebo|Placebo, twice daily for 6 weeks
16320301|NCT00497640|Procedure|Artificial Neural Network|Use of a predicted optimal CPAP
16320302|NCT00497614|Drug|adalimumab|
16320303|NCT00497601|Drug|Amphotericin B fat emulsion in visceral leishmaniasis|Amphotericin B in fat emulsion (Amphomul) 7.5 mg/kg on day 1 & 3 in group A Amphotericin B in fat emulsion (Amphomul) 10 & 5 mg/kg on day 1 & 3 in group B Amphotericin B in fat emulsion (Amphomul) 12.5 & 2.5 mg/kg on day 1 & 3 in group C Amphotericin B in fat emulsion (Amphomul) 15 mg/kg on day 1 in group D
16320304|NCT00497601|Drug|Amphotericin B fat emulsion|Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
16320305|NCT00497601|Drug|Amphotericin B in fat emulsion|Starting with 7.5 mg/kg on day 1 and 3, 10 and 5 mg/kg on day 1 and 3, 12.5 and 2.5 mg/kg on day 1 and 3 and finally 15 mg/kg on day 1
16320306|NCT00497588|Procedure|surgery|
16320307|NCT00497588|Radiation|radiotherapy|
16320308|NCT00497562|Drug|sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)|
16320309|NCT00497562|Drug|amitriptyline, fluoxetine and tramadol alone (control group)|
16320310|NCT00497549|Procedure|side-to-side stapled|5 cm of the mobilized stomach will be placed in the neck. Three interrupted sutures will be taken between the posterior wall of esophagus and anterior wall of stomach. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of esophagus and another between posterior corner of esophagus and the middle of the gastrotomy. The stapler device (Endopath, EZ45) will be introduced.The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis and the anterior edges of the gastrotomy and open esophagus will be approximated with interrupted 3-0 silk.
16320311|NCT00497549|Procedure|hand sewn|A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.
16320312|NCT00497536|Drug|Insulin Aspart (IAsp)|"IAsp 100 U.
~≈ bolus protocol: From 6 pm until 6 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm
~1 dose/h + 50 % s.c. (≈ bolus)."
16320313|NCT00497536|Drug|Insulin Aspart (IAsp).|"IAsp 100 U From 6 pm until 8 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm 50 % increase of basal rate"
16320314|NCT00497536|Drug|Insulin Aspart (IAsp)|"IAsp 100 U From 6 pm until 8 am
~• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
~From 8 am until 6 pm 50 % increase of basal rate"
16320315|NCT00497523|Drug|Beclomethasone dipropionate|
16320316|NCT00497523|Drug|Beclomethasone dipropionate/Salbutamol combination|
16320317|NCT00497523|Drug|Salbutamol|
16320318|NCT00497510|Procedure|Chiropractic manipulation|
16320319|NCT00497497|Drug|bevacizumab|(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
16320320|NCT00497497|Drug|cetuximab|Intravenous repeating dose
16320321|NCT00497497|Drug|FOLFIRI regimen|Intravenous repeating dose
16320322|NCT00497497|Drug|irinotecan|Intravenous repeating dose
16320323|NCT00497497|Drug|PRO95780|Intravenous repeating dose
16320324|NCT00497484|Drug|recombinant human somatotropin|
16320325|NCT00497471|Drug|Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)|
16320326|NCT00497471|Drug|iron (2 mg/kg/daily)|
16320327|NCT00497458|Drug|Testosterone|testosterone 40 or 80 mg once a day
16320328|NCT00497445|Procedure|angioplasty / surgery|Percutaneous vascular intervention or surgery for peripheral arterial disease
16320329|NCT00497445|Procedure|Angioplasty / surgery and exercise therapy|Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy
16320330|NCT00497419|Procedure|fast track|
16320331|NCT00497406|Procedure|Salivary gland transfer|Retrograde flow method
16320332|NCT00497406|Procedure|Helical Tomotherapy treatment|total of 30 fractions
16320333|NCT00497393|Behavioral|Clinical Decision Unit|a dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging.
16320334|NCT00497380|Dietary Supplement|Arginine|Oral nutritional supplement
16320335|NCT00497367|Device|Percutaneous Coronary Intervention (PCI) TAXUS Petal|TAXUS Petal, paclitaxel eluting stent
16320336|NCT00497354|Drug|Variation in volume of local anesthetic|
16320337|NCT00497354|Procedure|Ultrasound-guided interscalene brachial plexus block|
16320338|NCT00497341|Drug|cefuroxime|cefuroxime is administered at a dosage of 1.5 g before tourniquet inflation and release in experimental arm and only before tourniquet inflation in control arm
16320339|NCT00497341|Drug|placebo|cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery
16320340|NCT00497328|Drug|N-acetylcysteine|
16320341|NCT00497328|Drug|Sodium Bicarbonate|
16320342|NCT00497315|Drug|combination chemotherapy (pemetrexed + cisplatin)|pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
16320343|NCT00497315|Radiation|thoracic irradiation + pemetrexed|pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
16320344|NCT00497302|Behavioral|RBT|Contingency management and behavioral counseling including motivational interviewing
16320345|NCT00497302|Behavioral|usual care|receives usual comprehensive care at Center for Addiction and Pregnancy
16320346|NCT00497289|Drug|Lipofundin MCT/LCT 20 %|daily i.v. infusion for up to 5 days
16320347|NCT00497289|Drug|Lipidem 20%|daily i.v. infusion for up to 5 days
16320348|NCT00497276|Procedure|placement of popliteal catheter|Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
16320349|NCT00497263|Device|Niti CAR|
16321344|NCT00489736|Drug|amiodarone|oral administration
16320350|NCT00497250|Drug|Gefitinib|gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT.
16320351|NCT00497250|Device|Radiation Therapy|group 1.54Gy/27Fx concurrent with gefitinib group 2.56Gy/28Fx concurrent with gefitinib group 3.58Gy/29Fx concurrent with gefitinib group 4.60Gy/30Fx concurrent with gefitinib
16320352|NCT00497237|Drug|Beclomethasone plus formoterol fixed combination|100+6 pMDI
16320353|NCT00497237|Drug|Fluticasone plus salmeterol fixed combination|diskus 250/50
16320354|NCT00497224|Drug|Erlotinib|Erlotinib starting at 150 mg PO (by mouth) daily. Dose may increase or decrease by the study doctor as per protocol (study plan).
16320355|NCT00497211|Procedure|Intracoronary mononuclear cell infusion|
16320356|NCT00497198|Drug|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
16320357|NCT00497198|Drug|Placebo of MCI-196 Tablet|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
16320358|NCT00497185|Behavioral|Mindfulness-Based Cognitive Therapy for Functional Disorders|"Mindfulness-based cognitive therapy: A manualized program will be delivered by two instructors who are experienced cognitive therapists in eight weekly 3½-hour group training sessions and one follow-up session after a month involving up to 12 patients with somatoform disorders. The patients must be willing and able to attend and devote up to 1 hour per day for homework.
~The therapy is compared with a group of controls receiving shared care defined as: Treatment as usual augmented by psychiatric consultation intervention: The patients are offered a psychiatric consultation after the assessment interview. It is the aim to optimise treatment in the present health care system."
16320359|NCT00497172|Device|CYPHER Sirolimus-eluting stent|drug-eluting stent
16320360|NCT00497172|Device|Bx SONIC bare metal stent|bare-metal stent
16320361|NCT00497159|Other|Placebo|Placebo TID x 90 days
16320362|NCT00497159|Drug|Dimebon|Dimebon 20 mg TID x 90 days
16320363|NCT00497146|Drug|paricalcitol|2 µg capsule
16320364|NCT00497146|Drug|placebo|placebo capsule
16320365|NCT00497120|Drug|acetazolamide|
16320366|NCT00497120|Drug|placebo|
16320367|NCT00497120|Procedure|uvulopalatopharygoplasty|
16320368|NCT00497107|Drug|UFT, Calcium Folinate, PSK|
16320369|NCT00497107|Drug|UFT, Calcium Folinate|
16320370|NCT00497094|Device|carotid artery stenting|Using retrograde transfemoral access an overview aortic angiogram is established. A stiff wire is then placed in the external carotid or distal common carotid artery to introduce a long hydrophilic sheath into the common carotid artery. The stenosis is then crossed with a Filter wire. For stent implantation Monorail Carotid Wallstents or the Monorail Nitinol Stent of Boston Scientific are used. Road map or overlay technique with a magnification of 20 to 28 inch is used to localize the stenosis during the procedure. Finally a control angiogram is performed to ensure correct placement of the stent. After successful completion of the procedure, the arterial access site is closed using a standard closure device.
16320371|NCT00497081|Drug|mirtazapine|mirtazapine 30 mg daily for 3 months
16320372|NCT00497081|Drug|placebo|placebo 30 mg daily for 3 months
16320373|NCT00497068|Behavioral|tobacco abstinent contingent|Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
16320374|NCT00497068|Behavioral|non-contingent|Participants receive vouchers regardless of tobacco use status
16320375|NCT00497068|Behavioral|control|this group receives no vouchers
16320376|NCT00497055|Drug|Aripiprazole|
16320377|NCT00497055|Drug|Placebo|Sugar pill manufactured to mimic Aripiprazole gel caps.
16320378|NCT00497042|Device|Self Adjusting File|
16320379|NCT00497029|Drug|fluoride varnish|
16320380|NCT00497029|Behavioral|patient education|
16320381|NCT00497016|Drug|atorvastatin 80 mg|
16320382|NCT00497003|Drug|Treatment with either metoprolol or carvedilol|
16320383|NCT00496990|Behavioral|Enhanced care|this group received counseling, contingency management and methadone or detoxification
16320384|NCT00496990|Behavioral|control|this group receives the opportunity to participate in a support group
16320385|NCT00496977|Procedure|annual CT screening|
16320386|NCT00496964|Drug|Botulinum toxin A + exercise|Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain
16320387|NCT00496964|Drug|Placebo|Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome
16320388|NCT00496951|Device|Vagal tone assessment|An EKG will be obtained using a Physio-control EKG monitor (R wave Electronics of Florida) in standard application, with three chest leads. The EKG data is inputted into a vagal tone monitor (Delta Biometrix, Bethesda MD) which computes vagal tone from the EKG signal. This data is then transferred to a disk which is analyzed off-line.
16320389|NCT00496938|Device|XIENCE V®/ XIENCE PRIME™|Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
16320390|NCT00496873|Drug|Cytoxan|600 mg/m^2 on Day 1 of 21-day cycle.
16320391|NCT00496873|Drug|Nipent|4 mg/m^2 on Day 1 of 21 Day Cycle.
16320392|NCT00496873|Drug|Rituxan|375 mg/m^2 on Day 1 of 21 Day Cycle.
16320393|NCT00496860|Biological|ALT-801|Dose escalation (0.015 mg/kg, 0.04 mg/kg, 0.08 mg/kg, 0.12 mg/kg, 0.14 mg/kg, 0.16 mg/kg), intravenous infusions, two treatment cycle, each cycle with 4 daily on-dose infusion, 10 days rest between cycles.
16320394|NCT00496847|Drug|PERIOGEN|Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
16320395|NCT00496847|Drug|Beta TCP alone|Implantation of β-TCP (0.5 g) alone
16320396|NCT00496834|Drug|losartan potassium|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
16320430|NCT00496600|Drug|Patupilone|RAD001 will be taken orally starting at a dose of 30 mg every week for the first cohort of patients, one hour prior to administration of patupilone. Patupilone will then be administered as an infusion, starting at 5 mg/m2 for the first cohort of patients. The dosage and scheduling of RAD001 and patupilone during each 21-day cycle will vary according to cohort assignment
16320397|NCT00496834|Drug|Comparator: carvedilol|Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
16320398|NCT00496834|Drug|Comparator: losartan (+) hydrochlorothiazide (HCTZ)|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
16320399|NCT00496834|Drug|Comparator: carvedilol (+) hydrochlorothiazide|Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
16320400|NCT00496821|Drug|ALN-RSV01|
16320401|NCT00496808|Drug|Herceptin (Trastuzumab)|8 mg/kg IV Over 90 Minutes
16320402|NCT00496795|Other|epirubicin/docetaxel sequential|Epirubicin 60 mg/m2, q2w 4 cycles. Followed by docetaxel 100 mg/m2 q2w 4 cycles
16320403|NCT00496782|Drug|maraviroc|Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
16320404|NCT00496782|Procedure|Trofile Assay and HIV RNA quantification assay|Trofile Assay and HIV RNA quantification assay
16320405|NCT00496769|Drug|Apixaban|Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
16320406|NCT00496769|Drug|Acetylsalicylic acid|Tablets, oral, 81-324 mg, once daily, up to 156 weeks
16320407|NCT00496756|Drug|Sorafenib|initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg
16320408|NCT00496743|Device|Low-dose total skin electron beam therapy (4 Gy)|
16320409|NCT00496730|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
16320410|NCT00496730|Drug|Comparator: atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
16320411|NCT00496717|Device|Helicoidal fast scann|Each patient will have an computed aortic tomodensitometric scan without contrast injection. This procedure lasts few minutes and irradiation is low. The aortic calcium scoring is calculated using a specific program included in the scan machine
16320412|NCT00496704|Drug|capecitabine|
16320413|NCT00496704|Drug|gemcitabine hydrochloride|
16320414|NCT00496704|Drug|oxaliplatin|
16320415|NCT00496691|Behavioral|Family-based HIV prevention program|comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
16320416|NCT00496678|Behavioral|Navigation|Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system
16320417|NCT00496678|Behavioral|Standard of Care|Cancer patients receive standard of care for their cancer treatment
16320418|NCT00496665|Drug|Vandetanib|Taken orally once a day in 28-day cycles (the dose will vary)
16320419|NCT00496665|Drug|Cyclophosphamide|Metronic Chemotherapy: Low dose pills taken every day of each 28-day cycle
16320420|NCT00496665|Drug|Methotrexate|Metronic Chemotherapy: low dose pills taken on days 1 and 2 of each week
16320421|NCT00496652|Radiation|Radiotherapy|Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
16320422|NCT00496652|Drug|Zalutumumab|Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
16320423|NCT00496639|Procedure|angioplasty|Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.
16320424|NCT00496639|Procedure|stent placement|Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft
16320425|NCT00496626|Biological|Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)|Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
16320426|NCT00496626|Biological|Comparator: Placebo|aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
16320427|NCT00496613|Behavioral|Mini-Mental State Exam and Blood draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
16320428|NCT00496613|Behavioral|Mini-Mental State Exam and Blood Draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
16320429|NCT00496613|Behavioral|Mini-Mental State Exam and Blood Draw|The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
16320527|NCT00495820|Other|Placebo|Standard inactive pill.
16320431|NCT00496600|Drug|RAD001|RAD001 will be taken orally starting at a dose of 30 mg every week for the first cohort of patients, one hour prior to administration of patupilone. Patupilone will then be administered as an infusion, starting at 5 mg/m2 for the first cohort of patients. The dosage and scheduling of RAD001 and patupilone during each 21-day cycle will vary according to cohort assignment
16320432|NCT00496587|Drug|Capecitabine|800 mg/m^2 By Mouth Twice Daily On Days 1-21.
16320433|NCT00496587|Drug|Gemcitabine|900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15.
16320434|NCT00496587|Drug|Bevacizumab|10 mg/kg By Vein On Days 1 and 15.
16320435|NCT00496574|Biological|Novo Helisen Depot, Phostal|subcutaneous immunotherapy
16320436|NCT00496561|Biological|subcutaneous immunotherapy (House Dust Mites)|subcutaneous immunotherapy (House Dust Mites)
16320437|NCT00496561|Other|placebo of subcutaneous immunotherapy (House Dust Mites)|placebo of subcutaneous immunotherapy (House Dust Mites)
16320438|NCT00496548|Procedure|Fecal calprotectin|Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
16320439|NCT00496548|Procedure|Urinary PGE-M Level|Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
16320440|NCT00496535|Drug|TNFerade biologic|
16320441|NCT00496522|Procedure|Proton Beam Therapy|A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
16320442|NCT00496509|Drug|ZD6474 (Zactima) 100mg|
16320443|NCT00496509|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR)|
16320444|NCT00496509|Procedure|Biomarker Draws|
16320445|NCT00496509|Drug|ZD6474 (Zactima) 300mg|
16320446|NCT00496483|Drug|LCP Tacro (tacrolimus)|"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
~Other Names:
~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."
16320447|NCT00496483|Drug|Prograf|"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
~Other Names:
~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."
16320448|NCT00496470|Drug|Symbicort (budesonide/formoterol turbuhaler 320/9ug)|Symbicort (budesonide/formoterol turbuhaler 320/9ug)
16320449|NCT00496470|Drug|Spiriva (tiotropium bromide 18ug)|Spiriva (tiotropium bromide 18ug)
16320450|NCT00496457|Drug|Experimental|Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
16320451|NCT00496457|Drug|Placebo comparator|4 Capsules of PBO per day before noon meal
16320452|NCT00496444|Drug|Azacitidine|Starting Dose 20 mg/m^2 administered subcutaneously (under the skin), daily, for ten days (Days 1 -10) of every 4 Week Cycle.
16320453|NCT00496444|Drug|Valproic Acid|Starting Dose 10 mg/Kg once daily by mouth, every day of 4 Week Cycle.
16320454|NCT00496431|Drug|histone deacetylase inhibitor (ITF2357)|50 mg b.i.d. (or every 8 hours or every 6 hours), every day
16320455|NCT00496418|Device|Mesh in permanent colostomy|
16320456|NCT00496405|Drug|bevacizumab|
16320457|NCT00496392|Drug|Nasal fentanyl|Breakthrough pain in patients with breast or prostate cancer
16320458|NCT00496379|Drug|ZK219477|Given intravenously over approximately 30 minutes once every 3 weeks
16320459|NCT00496366|Drug|Capecitabine|The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).
16320460|NCT00496366|Drug|Lapatinib|The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.
16320461|NCT00496353|Drug|MK2461|MK2461 treatment, bid, 28-day
16320462|NCT00496340|Drug|Pentostatin|"Pre-conditioning therapy:
~All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
~Participant will receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3."
16320463|NCT00496340|Drug|Busulfan|"Pre-conditioning therapy:
~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
~Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600."
16320464|NCT00496340|Drug|Rituximab|"Pre-conditioning therapy:
~Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines."
16320465|NCT00496340|Procedure|Allogeneic Hematopoietic Cell Transplant|Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.
16320466|NCT00496327|Biological|Varicella Virus Vaccine Live (Oka-Merck)|VARIVAX(TM) (Refrigerated) [Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.
16320467|NCT00496314|Device|e2TM Cervical Cell Collector|
16320468|NCT00496301|Drug|Gemcitabine, Capecitabine and Sorafenib (6 cycles)|Gemcitabine: 1000 mg/m2 i.v. days 1 and 8. Capecitabine: 650 mg/m2 i.v. day 1 to 14. (change to 500mg/m2 after amendment nº2 (dated on 10/10/2007) Sorafenib:400 mg/12h v.o. day 1 to 21
16320469|NCT00496288|Radiation|Prophylactic radiation to the contralateral breast|The contralateral breast will be treated with 2 tangent fields, using 1.8-2 Gy/fx to a total dose of 50-50.4 Gy. The whole breast will be treated according to traditional guidelines and as described in the RTOG/NSABP B39 study. The heart should be maximally blocked for left sided breasts, included lung tissue should be reduced to minimum. No overlapping field is allowed on the skin between the two breast fields in the midline. Maximal dose should not exceed 110%
16320470|NCT00496275|Drug|Zactima (ZD6474)|
16320471|NCT00496275|Drug|Vinorelbine plus cisplatin|
16320472|NCT00496275|Drug|Gemcitabine plus cisplatin|
16320473|NCT00496262|Biological|Human Fibrinogen Concentrate|Single intravenous infusion of 70 mg/kg body weight
16320474|NCT00496236|Drug|TNFerade biologic|
16320475|NCT00496223|Drug|Sunitinib|Sunitinib will be given PO once daily on days 1-14 of each 21 day cycle. The exact dose of sunitinib will be determined during the Phase I part of the trial.
16320476|NCT00496223|Drug|Dacarbazine|Dacarbazine will be given at 1000 mg/m2 on day 1 of every 21 day cycle.
16320477|NCT00496197|Drug|Eraxis (anidulafungin)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
16320478|NCT00496197|Drug|Diflucan (fluconazole)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.
16320479|NCT00496197|Drug|Vfend (voriconazole)|Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
16320480|NCT00496184|Drug|Nifedipine cream topical application|
16320481|NCT00496158|Drug|Clevudine|
16320482|NCT00496158|Drug|Adefovir|
16320483|NCT00496145|Behavioral|Spanish Diabetes Self-Management Program|small-group self management education program
16320484|NCT00496132|Drug|PRO131921|Escalating doses by IV infusion
16320485|NCT00496119|Radiation|Proton Beam Therapy|70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.
16320486|NCT00496119|Radiation|Photon Beam Therapy|Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.
16320487|NCT00496106|Behavioral|Telephone counseling|6 telephone counseling sessions
16320488|NCT00496106|Behavioral|Telephone interview|telephone interview
16320489|NCT00496093|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
16320490|NCT00496080|Device|Doppler-Guided Uterine Artery Occlusion Device (DUAO)|Investigational transvaginal clamp inserted one time for 6 hours.
16320491|NCT00496067|Device|Doppler-Guided Uterine Artery Occlusion Device|For bilateral occlusion of the uterine arteries
16320492|NCT00496054|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
16320493|NCT00496041|Procedure|Registry|A Registry will be used.
16320494|NCT00496028|Drug|AZD0530|oral tablet
16320495|NCT00496028|Drug|Carboplatin|intravenous infusion
16320496|NCT00496028|Drug|Paclitaxel|intravenous infusion
16320497|NCT00496015|Biological|Pneumococcal conjugate vaccine GSK1024850A.|1 intramuscular injection.
16320498|NCT00496015|Biological|Infanrix hexa.|1 intramuscular injection.
16320499|NCT00496015|Biological|Meningococcal vaccine GSK134612.|1 intramuscular injection.
16320500|NCT00496015|Drug|Paracetamol.|Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.
16320501|NCT00496002|Drug|Clevudine|
16320502|NCT00496002|Drug|Adefovir|
16320503|NCT00495989|Procedure|saliva sampling + dental calculus collection|
16320504|NCT00495976|Other|A commercially produced cordial drink|
16320505|NCT00495963|Procedure|bronchoaleolar lavage|
16320506|NCT00495963|Procedure|Bronchoscopy|
16320507|NCT00495950|Behavioral|Questionnaire|Questionnaires relating to symptoms experienced during and following standard cancer treatment.
16320508|NCT00495924|Procedure|Pancreatic resection (PD)|PD is a standard therapeutic surgical procedure. No additional interventions are performed.
16320509|NCT00495898|Device|CYPHER sirolimus-eluting stent|drug-eluting stent
16320510|NCT00495898|Device|uncoated Bx VELOCITY balloon-expandable stent|bare metal stent
16320511|NCT00495885|Drug|volinanserin (M100907)|oral, one tablet taken around bedtime
16320512|NCT00495885|Drug|Placebo|oral, one tablet taken around bedtime
16320513|NCT00495872|Drug|Dasatinib|50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days
16320514|NCT00495872|Drug|Erlotinib|100 mg PO Daily for 28 Days Every 28 Days
16320515|NCT00495872|Drug|Lapatinib|1000 mg PO Daily for 28 Days Every 28 Days
16320516|NCT00495872|Drug|Lenalidomide|15 mg PO Daily for 28 Days Every 28 Days
16320517|NCT00495872|Drug|Sorafenib|400 mg PO Daily for 21 Days Every 28 Days
16320518|NCT00495872|Drug|Sunitinib|25 mg PO Daily for 21 Days Every 28 Days
16320519|NCT00495872|Drug|Valproic Acid|40 mg/kg PO Daily for 7 Days, then 7 Days Off
16320520|NCT00495859|Dietary Supplement|Immunonutrition|food for special medical purpose (FSMP)
16320521|NCT00495859|Dietary Supplement|food for special medical purposes (FSMP)|an isocaloric isonitrogenous non-specific nutritional support
16320522|NCT00495846|Drug|Octreotide-LAR, Lanreotide Autogel|Octreotide-LAR intramuscular, dose of 30 mg every 28 days to increase up to 60 mg; lanreotide autogel 120 mg deep subcutaneous every 28 days for 3 months then uptitrated according with the protocol.
16320523|NCT00495846|Other|Locoregional treatments|
16320524|NCT00495833|Behavioral|Personalized brochure|either photo personalization, blood pressure personalization, both, or no personalization
16320525|NCT00495833|Behavioral|Promotional gift|half of participants who go to a fire station will receive a gift card.
16320526|NCT00495820|Drug|Methylphenidate|Subject will receive 5mg twice a day for two weeks then 10mg twice a day until week 12 of the study.
16320528|NCT00495807|Behavioral|No Words|Without any words was given during pain management
16320529|NCT00495807|Behavioral|Positive words|Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
16320530|NCT00495807|Behavioral|Partially Negative Words|Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
16320531|NCT00495807|Behavioral|Totally Negative Words|Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
16320532|NCT00495794|Behavioral|Clinical pharmacist-based intervention|Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms
16320533|NCT00495781|Procedure|%-hypo (laboratory parameter, functional iron deficiency)|
16320534|NCT00495781|Procedure|CHr (laboratory parameter, functional iron deficiency)|
16320535|NCT00495781|Procedure|RET-HE (laboratory parameter, functional iron deficiency)|
16320536|NCT00495768|Behavioral|Group Training|Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.
16320537|NCT00495755|Drug|Alemtuzumab (Campath)|An escalating dose given over 4 weeks
16320538|NCT00495729|Drug|SB-649868|Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
16320539|NCT00495729|Drug|Placebo|Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
16320540|NCT00495729|Drug|Simvastatin|Subjects will receive Simvastatin 10 mg tablets orally.
16320541|NCT00495716|Drug|acyclovir|800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
16320542|NCT00495716|Drug|acyclovir|400 mg acyclovir orally twice daily for 1 year
16320543|NCT00495703|Behavioral|Exercise|6-months of regular aerobic exercise
16320544|NCT00495703|Behavioral|Usual Care|6-months of behavioral strategies to aid memory/cognition
16320545|NCT00495690|Drug|Oral zinc gluconate (5 mg elemental)|Each infant in the study received placebo or 5 mg of elemental zinc (1 RDA) as zinc acetate syrup once daily from 4 weeks of age till 6 months of age.
16320546|NCT00495677|Drug|PF-00232798|Solution, 20 mg. once daily, 10 days
16320547|NCT00495677|Drug|PF-00232798|Solution, 150 mg. once daily, 10 days
16320548|NCT00495677|Drug|PF-00232798|Solution, 5 mg. once daily, 10 days
16320549|NCT00495677|Drug|PF-00232798|Solution, 40 mg. once daily, 10 days
16320550|NCT00495677|Drug|PF-00232798|Solution, 300 mg. once daily, 10 days
16320551|NCT00495677|Drug|PF-00232798|Solution, 400 mg. once daily, 10 days
16320552|NCT00495664|Device|Titan stent and Taxus-Liberte stent|
16320553|NCT00495651|Drug|Antiretroviral medications|Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed.
16320554|NCT00495651|Drug|Antiretroviral medications+Isoniazid prophylaxis|"Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed.
~Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion"
16320555|NCT00495651|Drug|Antiretroviral medications|Early ART initiation on the day of inclusion, before reaching the current WHO criteria
16320556|NCT00495651|Drug|Antiretroviral medications+Isoniazid prophylaxis|"Early Antiretroviral medications initiation on the day of inclusion, before reaching the current WHO criteria
~Isoniazid prophylaxis: 300 mg of INH once a day before breakfast for six months, starting one month after study inclusion"
16320557|NCT00495625|Drug|Sunitinib Malate|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
16320558|NCT00495612|Drug|Omalizumab|Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
16320559|NCT00495612|Drug|Placebo|Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
16320560|NCT00495599|Procedure|Cytokines assessed from fat tissue|Cytokines assessed from fat tissue
16320561|NCT00495586|Drug|Placebo|One pill to be taken every eight hours for 8 days
16320562|NCT00495586|Drug|Amoxicillin and clavulanic acid|500-125 mg to be taken every eight hours for 8 days
16320563|NCT00495573|Drug|acyclovir|400 mg acyclovir, orally three times a day for 5 days
16320564|NCT00495560|Drug|Addition of misoprostol 25 mcg 12 hours before induction|Misoprostol given buccally the night before induction
16320565|NCT00495547|Drug|Azacitidine|Azacitidine
16320566|NCT00495547|Drug|Beta Erythropoietin|Beta Erythropoietin
16320567|NCT00495521|Drug|4-Aminosalicylic acid extended release granules|Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm
16320568|NCT00495508|Drug|Quinine|
16320569|NCT00495508|Drug|artemether / lumefantrine|
16320570|NCT00495495|Device|Ozone treatment|Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits.
16320571|NCT00495495|Device|Placebo treatment|Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.
16320572|NCT00495469|Drug|GSK189075|GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet
16320573|NCT00495469|Drug|Placebo|Available as Placebo matching tablet to GSK189075
16320574|NCT00495443|Device|Peterio|
16320575|NCT00495417|Biological|AFFITOPE AD01|s.c. injection
16320576|NCT00495417|Biological|AFFITOPE AD01 adjuvanted|s.c. injection
16320577|NCT00495404|Behavioral|Physician Treatment Guidelines|
16320578|NCT00495391|Drug|Nitazoxanide|One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
16320579|NCT00495391|Drug|Placebo|One oral placebo tablet twice daily for 52 weeks.
16321345|NCT00489723|Drug|tamsulosin 0.4mg|
16320580|NCT00495391|Biological|Peginterferon alfa-2a|Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
16320581|NCT00495391|Drug|Ribavirin|1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
16320582|NCT00495378|Drug|epoetin alfa|
16320583|NCT00495365|Drug|Epoetin alfa|
16320584|NCT00495352|Drug|Hihg-doseNRT, Low-dose NRT, bupropion|
16320585|NCT00495339|Drug|Levofloxacin|500-1000 mg once a day daily per os with combination of drugs.
16320586|NCT00495326|Drug|Nevirapine based therapy|"Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg
~Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)"
16320587|NCT00495326|Drug|Efavirenz based therapy|Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)
16320588|NCT00495326|Drug|Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)|"Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase.
~Continuation phase: 4 months daily H(RMP).
~Patients with meningitis will receive Streptomycin instead of E during intensive phase."
16320589|NCT00495313|Drug|doxycycline|COL-101, QD plus metronidazole
16320590|NCT00495313|Drug|doxycycline|40 mg with metronidazole QD
16320591|NCT00495287|Drug|cytosine arabinoside|"Arm A: use of standard-dose cytosine arabinoside (100 mg/m2/bd iv. on days 1-7) in association with idarubicin and etoposide.
~Arm B: use of high-dose cytosine arabinoside (1000-2000 mg/m2/bd according to age +/-65 years iv. on days 1-2 and 8-9) in association with idarubicin."
16320592|NCT00495274|Drug|Formulation A|Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A.
16320593|NCT00495274|Drug|Formulation B|Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A.
16320594|NCT00495274|Drug|Formulation C|Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.
16320595|NCT00495274|Drug|Formulation D|Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A.
16320596|NCT00495274|Drug|Formulation E|Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A.
16320597|NCT00495274|Drug|Formulation F|Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A.
16320598|NCT00495274|Drug|Formulation G|Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast
16320599|NCT00495261|Behavioral|Mindfulness-enhanced cognitive behavioural therapy (MCBT)|a variation of cognitive behavioural therapy (CBT)
16320600|NCT00495261|Behavioral|relaxation-enhanced cognitive behavioural therapy (RCBT)|a variation of cognitive behavioural therapy (CBT)
16320601|NCT00495248|Behavioral|Group intervention inspired by Lifestyle Redesign|Group intervention inspired by Lifestyle Redesign
16320602|NCT00495248|Behavioral|Group intervention inspired by Lifestyle redesign|Lifestyle programme once a week for two hours over an intervention period of 9 months
16320603|NCT00495235|Behavioral|Questionnaire|Questionnaire taking about 20 minutes to complete.
16320604|NCT00495222|Procedure|Tissue plication|Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
16320605|NCT00495222|Device|Endoscopic Suturing System|Tissue plication of dilated GJ stoma
16320606|NCT00495222|Device|Tissue Plication|Tissue plication for GJ stoma reduction
16320607|NCT00495209|Other|Qigong|EQT daily for 5 consecutive days prior to surgery.
16320608|NCT00495196|Procedure|Experimental lung function test|Administration of several CO2 gas mixtures
16320609|NCT00495183|Drug|caffeine|caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
16320610|NCT00495183|Drug|Biperiden|Biperiden 2-4 mg/d, divided in 2 doses per day.
16320611|NCT00495183|Drug|Placebo|Placebo
16320612|NCT00495170|Drug|Carboplatin|2 area under curve (AUC) by vein Weekly
16320613|NCT00495170|Radiation|Proton Radiotherapy|2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).
16320614|NCT00495170|Drug|Paclitaxel|50 mg/m^2 by vein Weekly
16320615|NCT00495157|Behavioral|Symptom-based adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
16320616|NCT00495157|Behavioral|Biomarker-based adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
16320617|NCT00495157|Behavioral|Guideline-based adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
16320618|NCT00495144|Drug|TH-302|
16320619|NCT00495131|Drug|Pegylated interferon alfa-2a plus ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
16320620|NCT00495131|Drug|Pegylated interferon alfa-2a plus ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
16320621|NCT00495118|Drug|risperidone|
16320622|NCT00495105|Behavioral|Two Servings of Dairy Snacks|2 servings of dairy products as snacks at school to third, fourth, and fifth grade students each day for 24 weeks. The serving size of each dairy snack is based on its calcium content with the goal of adding an extra 300 mg of calcium to the intervention group's daily intake.
16320623|NCT00495092|Drug|Caffeine|Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
16320624|NCT00495092|Drug|Biperiden|Biperiden 2-4 mg/d p.o.
16320625|NCT00495092|Drug|Placebo|Placebo + Placebo
16320711|NCT00494494|Drug|Standard Care|topical antibiotic for 10 days plus topical corticosteroids for 1 month
16320626|NCT00495079|Drug|Marqibo® (vincristine sulfate liposomes injection)|Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.
16320627|NCT00495066|Drug|Ipilimumab|Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; Until disease progression, unacceptable toxicity or withdrawal of consent
16320628|NCT00495053|Drug|hMaxi-K|Two dose levels (5000 µg/90 mL intravesical instillation and 10000 µg/90 mL intravesical instillation)
16320629|NCT00495053|Other|Placebo|Matching placebo (PBS-20% sucrose)
16320630|NCT00495040|Radiation|Proton Radiotherapy|87.5 CGE with 2.5 Gy/fraction for 35 treatments
16320631|NCT00495027|Behavioral|Internet-delivered Stress Innoculation Training|
16320632|NCT00495014|Drug|GSK376501|
16320633|NCT00495014|Drug|Placebo|
16320634|NCT00494988|Drug|insulin aspart|
16320635|NCT00494988|Drug|insulin NPH|
16320636|NCT00494975|Device|Narrow band UVB phototherapy , long wave UVA phototherapy|A UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. ) and 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
16320637|NCT00494962|Drug|lecozotan SR|
16320638|NCT00494949|Drug|Hemospan (MP4OX)|200, 400, 600, 750, or 1000 mL of Hemospan (MP4OX)
16320639|NCT00494949|Drug|Ringer's lactate|200, 400, 600, 750, or 1000 mL of Ringer's lactate solution
16320640|NCT00494910|Behavioral|Meaning Centered Group Psychotherapy|this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future
16320641|NCT00494910|Behavioral|Supportive Group Psychotherapy|The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.
16320642|NCT00494897|Drug|Asparaginase|
16320643|NCT00494897|Drug|Cyclophosphamide|
16320644|NCT00494897|Drug|Cytarabine|
16320645|NCT00494897|Drug|Daunorubicin|
16320646|NCT00494897|Drug|Mercaptopurine|
16320647|NCT00494897|Drug|Prednisone|
16320648|NCT00494897|Drug|Vincristine|
16320649|NCT00494897|Drug|Methotrexate|
16320650|NCT00494897|Procedure|Intrathecally treatment|
16320651|NCT00494884|Drug|vildagliptin|
16320652|NCT00494871|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)
16320653|NCT00494871|Drug|Warfarin|Participants orally administered a warfarin potassium tablet (INR [international normalized ratio] target was 1.6-2.6 for patients >70 years and 2.0-3.0 for patients <70 years)
16320654|NCT00494871|Drug|Rivaroxaban placebo|Participants orally administered a rivaroxaban placebo tablet
16320655|NCT00494871|Drug|Warfarin placebo|Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)
16320656|NCT00494858|Behavioral|Cognitive behavioral therapy - focused (CBT-EF)|Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
16320657|NCT00494858|Behavioral|Cognitive behavioral therapy - broad (EB)|Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
16320658|NCT00494845|Behavioral|Mindfulness|8-week mindfulness program will be compared to an education control group.
16320659|NCT00494845|Behavioral|Control: Health Education Class|8-week education program
16320660|NCT00494832|Drug|Dexmedetomidine|"10 minutes loading dose of 0.9 mcg/kg
~Maintenance dose of 0.6 mcg/kg/hour"
16320661|NCT00494832|Drug|Normal Saline|"10 minutes loading dose of 0.9 mcg/kg
~Maintenance dose of 0.6 mcg/kg/hour"
16320662|NCT00494806|Other|Rocking Chair Intervention|Patient out of bed rocking in a rocking chair at a constant rate of one rock cycle per second (back and forth), in ten to twenty minute increments, for at least sixty minutes per day or 3600 rock cycles and ambulate at least twice per day beginning the first postoperative day.
16320663|NCT00494793|Procedure|VAWC and mesh mediated fascial traction|"The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
~The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
~Finally the mesh is removed and the fascia is closed"
16320664|NCT00494780|Drug|Ofatumumab|ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given
16320665|NCT00494780|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
16320666|NCT00494780|Drug|Doxorubicin|Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
16320667|NCT00494780|Drug|Vincristine|Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
16320668|NCT00494780|Drug|Prednisolone, Prednisone or equivalent|100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
16320669|NCT00494767|Drug|GW869682|GW869682 tablet with a dose strength of 250 mg will be available for subjects
16320670|NCT00494767|Drug|GSK189075|GSK189075 tablet with a dose strength of 250 mg will be available for subjects
16320671|NCT00494767|Drug|GSK189075-Placebo|Placebo tablets to match GSK189075 250 mg will be available for subjects
16320672|NCT00494767|Drug|GW869682-Placebo|Placebo tablets to match GW869682 250 mg will be available for subjects
16320806|NCT00493662|Drug|0.15% sodium Hyaluronate|
16320807|NCT00493662|Drug|sodium chloride|
16320673|NCT00494741|Drug|mycophenolate mofetil|Patients randomized in this group will receive 750 mg of MMF per os twice a day starting on the day of transplant. MMF dose will be reduced in case of white blood cell count lower than 2,000/mm3 and whenever deemed clinically appropriate.
16320674|NCT00494741|Drug|azathioprine|Patients randomized in this group will receive 75 mg of AZA per os (or 125 mg if body weight > 75 kg) once a day starting on the day of transplant. AZA dose will be reduced in case of white blood cell count lower than 2,000/mm3 and whenever deemed clinically appropriate.
16320675|NCT00494728|Behavioral|Smoking Cessation Treatment|12 60-minute individual sessions of standard smoking cessation treatment.
16320676|NCT00494728|Drug|Nicotine Replacement Therapy|21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.
16320677|NCT00494728|Behavioral|CBASP|Individual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking.
16320678|NCT00494715|Drug|Benazepril|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16320679|NCT00494715|Drug|Valsartan|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16320680|NCT00494715|Drug|Benazepril/Valsartan|Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
16320681|NCT00494702|Procedure|Resuscitation|Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%
16320682|NCT00494702|Procedure|Resuscitation|Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%
16320683|NCT00494676|Device|High power (57 prism diopter) peripheral prism glasses|All patients will wear two pairs of prism glasses in a crossover design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks
16320684|NCT00494676|Device|Low power sham peripheral prism glasses|Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.
16320685|NCT00494663|Drug|DIO-902|150mg tablet once per day for 16 weeks
16320686|NCT00494663|Drug|DIO-902|300mg tablet once per day for 16 weeks
16320687|NCT00494663|Drug|DIO-902|450mg DIO-902 tablet once daily for 16 weeks
16320688|NCT00494663|Drug|DIO-902 placebo|DIO-902 placebo tablet once daily for 16 weeks
16320689|NCT00494663|Drug|DIO-902|150mg tablet of DIO-902 once daily for 16 weeks
16320690|NCT00494663|Drug|DIO-902|300mg DIO-902 tablet daily for 16 weeks
16320691|NCT00494663|Drug|DIO-902|450mg DIO-902 tablet for 16 weeks
16320692|NCT00494663|Drug|DIO-902 placebo|DIO-902 placebo tablet once daily for 16 weeks
16320693|NCT00494650|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 12 to 16 counseling sessions, occurring weekly or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions.
16320694|NCT00494650|Behavioral|Brief PTSD treatment|Brief PTSD treatment will include three weekly meetings with a therapist. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.
16320695|NCT00494637|Drug|sodium bicarbonate|isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
16320696|NCT00494624|Drug|prednisolone|
16320697|NCT00494611|Drug|Peri operative Cetuximab.|Cetuximab will be given immediately preoperative and early post surgery period.
16320698|NCT00494598|Drug|Sufentanil|200 mcg intra-arterial one time bolus
16320699|NCT00494585|Drug|CEP-701|80 mg orally twice a day for 30 days
16320700|NCT00494572|Drug|Montelukast|10 mg rapid dissolving granule in sterile water orally once
16320701|NCT00494572|Other|sterile water|sterile water
16320702|NCT00494559|Drug|Pioglitazone|Actos 15mg once a day before breakfast
16320703|NCT00494559|Drug|Placebo|Placebo drug with the same appearance as actos
16320704|NCT00494546|Procedure|Pd-103 with 20 vs 44 Gy supplemental beam XRT|
16320705|NCT00494533|Drug|Remodulin (treprostinil sodium)|
16320706|NCT00494520|Procedure|Errorful training condition|"Errorful training condition: Participant saw a picture and named it without any cues. If an error was produced, the cue with the least amount of information was provided (e.g. for pumpkin, pu). Cues with increasing information were provided until the picture was correctly named (e.g. for pumpkin: pump, pumpki, then pumpkin). Once the correct name was provided, the trial ended."
16320707|NCT00494520|Procedure|Errorless training condition|"Errorless learning (EL) condition: Participant saw a picture with its name, and repeated the word. The participant continued to name the picture as the auditory cues provided less and less of the word (e.g. for banana she would hear banan, bana then ba and finally no cue). If an error was produced at any stage, the whole word was presented, the participant repeated it, and the trial ended."
16320708|NCT00494507|Drug|Dichlorphenamide (double-blind)|50mg tablet; maximum dosage 400mg/day
16320709|NCT00494507|Drug|Placebo (double-blind)|Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
16320710|NCT00494507|Drug|Dichlorphenamide (open-label)|50mg tablet; maximum dosage 400mg/day
16320808|NCT00493662|Drug|sodium phosphate monobasic|
16320712|NCT00494494|Drug|nepafenac|liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid
16320713|NCT00494481|Drug|Vandetanib (ZD6474)|once daily oral dose
16320714|NCT00494481|Drug|Docetaxel|intravenous infusion
16320715|NCT00494468|Drug|Zolpidem|
16320716|NCT00494455|Device|continuous subcutaneous glucose monitoring|continuous subcutaneous glucose monitoring for 72h
16320717|NCT00494455|Device|continuous subcutaneous glucose monitoring|continuous subcutaneous glucose monitoring for 72h
16320718|NCT00494442|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16320719|NCT00494442|Drug|KU-0059436 (AZD2281)(PARP inhibitor)|oral
16320720|NCT00494429|Drug|Morphine|Gestational Age< 29 weeks: A loading dose of 0.05 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.005 mg/kg/h.
16320721|NCT00494429|Drug|Morphine|Gestational Age>= 29 weeks: A loading dose of 0.1 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.01 mg/kg/h.
16320722|NCT00494416|Other|delivery approaches of malaria intermittent preventive treatment in pregnancy|"Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.
~Joint with advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs)."
16320723|NCT00494377|Drug|duloxetine|
16320724|NCT00494351|Procedure|Long-pulsed Nd:YAG laser 1064 nm|Laser once monthly
16320725|NCT00494338|Drug|Docetaxel|
16320726|NCT00494312|Drug|Pioglitazone|Pioglitazone 15 mg or 30 mg titrated to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 156 weeks.
16320727|NCT00494312|Drug|Glyburide|Pioglitazone placebo-matching tablets, orally, once daily and glyburide 5 mg or 10 mg titrated to 15 mg, capsules, orally, once daily for up to 156 weeks.
16320728|NCT00494299|Drug|Sorafenib (Nexavar, BAY43-9006)|Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
16320729|NCT00494299|Drug|Placebo|Placebo: matching placebo
16320730|NCT00494286|Behavioral|Abused-focused cognitive behavioral therapy (AF-CBT)|Practitioners will be randomly assigned to provide the AF-CBT treatment for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive AF-CBT at treatment visits. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months.
16320731|NCT00494286|Behavioral|Treatment as usual (TAU)|This condition consists of those practitioners in each agency who will not receive study training in AF-CBT. These practitioners will simply provide services as available within their agencies.
16320732|NCT00494273|Behavioral|Cognitive Behavioral and Standard Care with Healthy Living|
16320733|NCT00494260|Behavioral|Social Learning and Cognitive Behavioral Therapy (SLCBT)|The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques
16320734|NCT00494260|Behavioral|Education Support (ES)|The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention.
16320735|NCT00494247|Device|coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cells|coronary stent covered with anti-CD34 antobody, (Genous, R-stent, produced by OrbusNeich). 30 patients will undergo PCI with implantation of Genous stent and 30 patients will receive bare metal stent (BMS)
16320736|NCT00494234|Drug|KU-0059436 (AZD2281) (PARP inhibitor)|oral
16320737|NCT00494234|Drug|KU-0059436 (AZD2281) (PARP inhibitor)|
16320738|NCT00494221|Drug|AZD2171|oral tablet
16320739|NCT00494221|Drug|FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)|intravenous infusion
16320740|NCT00494221|Drug|Placebo Cediranib|oral tablet
16320741|NCT00494208|Drug|Testosterone|Testosterone ester
16320742|NCT00494195|Genetic|rAAV1.tMCK.human-alpha-sarcoglycan- First cohort|"The first cohort of subjects with LGMD2D (alpha-sarcoglycan deficiency) and proven mutations will undergo gene transfer with a minimum of three subjects enrolled into this cohort and will receive a total of 1.5 ml volume of study agent in two to six separate injections into the selected muscle (extensor digitorum brevis) or other muscle if more appropriate upon considering the individual patient. The dose will be 3.25 X 10 to the 11 vg in 1.5 ml.
~In each cohort, only one extremity will receive vector with transgene while the opposite extremity will be injected with placebo."
16320743|NCT00494195|Genetic|Genetic: rAAV1.tMCK.human-alpha-sarcoglycan- Second cohort|The second cohort will receive the same dosis of 3.25 X 10 to the 11 vg in 1.5 ml delivered to muscle according to the same paradigm. In each cohort, only one extremity will receive vector with transgene while the opposite extremity will be injected with placebo.
16320744|NCT00494182|Drug|Carboplatin|Given IV
16320745|NCT00494182|Drug|Paclitaxel|Given IV
16320746|NCT00494182|Drug|Sorafenib|Given PO
16320747|NCT00494156|Drug|heparin|
16320748|NCT00494156|Drug|aspirin and clopidogrel|
16320749|NCT00494143|Device|CESR Prosthetic Foot|a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle
16320750|NCT00494143|Device|typical prosthetic foot|patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team
16320751|NCT00494143|Device|standardized prosthetic foot|a standard foot that has had weights applied to match the mass of the CESR foot
16320752|NCT00494117|Device|ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
16320893|NCT00493025|Radiation|radiation therapy|Radiotherapy
16320753|NCT00494104|Dietary Supplement|Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day|Infants receive daily 0.5 ml of code labeled supplement
16320754|NCT00494091|Drug|Temsirolimus (CCI-779)|20 mg/m2 IV TEMSR weekly (Japan, n=6)
16320755|NCT00494091|Drug|Temsirolimus (CCI-779)|25 mg IV TEMSR weekly (all other pts)
16320756|NCT00494078|Device|Real-time glucose monitoring system (Guardian, Medtronic)|Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
16320757|NCT00494078|Drug|intensive insulin therapy|intensive insulin therapy according to an algorithm
16320758|NCT00494065|Other|Home exercise|Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.
16320759|NCT00494065|Other|Chiropractic Spinal Manipulative Therapy + Home exercise|The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
16320760|NCT00494052|Behavioral|Heart to Heart (Web-Based Decision Aid)|Participants in the intervention group will access Heart to Heart, a Web site designed to educate them about their overall CHD risk, specific risk factors, and strategies and preferences for risk reduction.
16320761|NCT00494052|Behavioral|Physician Education Session|A physician education session will be included in the program.
16320762|NCT00494039|Procedure|Radioactive seed implant to prostate|
16320763|NCT00494026|Drug|pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles
16320764|NCT00494026|Drug|carboplatin|Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles
16320765|NCT00494026|Procedure|radiotherapy|2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)
16320766|NCT00494013|Drug|Insulin Lispro Protamine Suspension|Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
16320767|NCT00494013|Drug|Detemir|Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
16320768|NCT00493987|Drug|Testosterone Enanthate|testosterone ester
16320769|NCT00493987|Drug|Dutasteride|5 alpha-reductase inhibitor
16320770|NCT00493974|Drug|Zileuton|Zyflo tablets, 600 mg, 4 times a day
16320771|NCT00493974|Drug|Placebo|Placebo 4 x daily
16320772|NCT00493961|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)
16320773|NCT00493948|Device|ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
16320774|NCT00493922|Procedure|Rapid diagnostic test|Introduction of rapid diagnostic test for malaria
16320775|NCT00493922|Procedure|Microscopy|Microscopy for diagnosis of malaria
16320776|NCT00493922|Procedure|Clinical diagnosis for malaria|The use of Clinical diagnosis for the diagnosis of malaria
16320777|NCT00493909|Procedure|intrathecal opioids and thoracic paravertebral analgesia|
16320778|NCT00493909|Procedure|thoracic epidural analgesia|
16320779|NCT00493896|Drug|Fondaparinux|The dose for Arixtra is 2.5 mg once daily, subcutaneously.
16320780|NCT00493896|Drug|Enoxaparin|The dose for Lovenox is 40 mg once daily, subcutaneously.
16320781|NCT00493883|Device|yttrium Y 90 microspheres (TheraSphere®)|Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver
16320782|NCT00493870|Drug|Docetaxel|Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
16320783|NCT00493870|Drug|Doxorubicin|• Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).
16320784|NCT00493870|Drug|Cyclophosphamide|600 mg/m2 IV over 15-30 minutes on Day 1.
16320785|NCT00493857|Drug|Nimotuzumab Humanized Monoclonal Antibody|Nimotuzumab 400mg every week
16320786|NCT00493857|Drug|Nimotuzumab|Nimotuzumab 400mg every 2 weeks
16320787|NCT00493844|Other|Exercise testing|Exercise testing
16320788|NCT00493844|Other|Clinical evaluation + NTproBNP|Clinical evaluation + NTproBNP levels
16320789|NCT00493831|Drug|nicotine polacrilex, transdermal system or inhaler|
16320790|NCT00493818|Drug|GSK690693|
16320791|NCT00493805|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks(Group A) or 60 weeks (Group B) postrandomization.
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks (Group A) or 60 weeks (Group B) postrandomization"
16320792|NCT00493805|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks"
16320793|NCT00493792|Device|Stryker X3 crosslink|Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
16320794|NCT00493779|Procedure|Blood Collection|4 weeks
16320795|NCT00493766|Drug|LBH589|
16320796|NCT00493753|Procedure|Acupuncture|
16320797|NCT00493740|Procedure|chocolate cake|
16320798|NCT00493727|Drug|N-acetylcysteine(Mucomyst)|
16320799|NCT00493714|Behavioral|Questionnaire|Surveys lasting 30 minutes or more.
16320800|NCT00493701|Behavioral|High Fat Diet|Daily eating
16320801|NCT00493701|Behavioral|Low Fat Diet|Life style eating habits
16320802|NCT00493688|Other|Cardiopulmonary Exercise Testing (CPET)|Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
16320803|NCT00493675|Procedure|endoscopic bile duct stenting|
16320804|NCT00493662|Drug|Polyethylene Glycol 400 0.4%|
16320805|NCT00493662|Drug|Propylene Glycol 0.3%|
16320809|NCT00493649|Drug|Taxotere|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
16320810|NCT00493649|Drug|Cytoxan|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
16320811|NCT00493649|Drug|Herceptin|On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
16320812|NCT00493636|Drug|Gemcitabine|Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
16320813|NCT00493636|Drug|Sorafenib|Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
16320814|NCT00493636|Drug|Placebo|Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
16320815|NCT00493636|Drug|Capecitabine|Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
16320816|NCT00493623|Drug|Placebo|Placebo i.v. single dose
16320817|NCT00493623|Drug|ibandronate [Bonviva/Boniva]|3mg i.v. single dose
16320818|NCT00493610|Drug|N-acetylcysteine(Mucomyst)|
16320819|NCT00493584|Procedure|Primary Percutaneous Coronary Intervention|Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
16320820|NCT00493584|Procedure|Coronary angiography / Percutaneous coronary intervention|Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
16320821|NCT00493571|Drug|Gimatecan|Starting dose: 0.6 mg capsules administered orally once daily.
16320822|NCT00493558|Device|Trabecular Metal Intervertebral Cage with RSA beads|Roentgen Stereophotogrammetric Analysis beads will be inserted at time of implant of the Trabecular Metal Intervertebral Cage.
16320823|NCT00493545|Biological|HspE7 and Poly-ICLC|3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
16320824|NCT00493532|Drug|ibandronate [Bonviva/Boniva]|3mg iv every 3 months
16320825|NCT00493519|Procedure|chocolate cake|
16320826|NCT00493506|Drug|ProAlgaZyme|
16320827|NCT00493493|Procedure|surgery (Pore Excision, Curettage, and Injection of Cymetra)|
16320828|NCT00493480|Drug|carvedilol|6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 25 mg carvedilol daily.
16320829|NCT00493480|Drug|propranolol|80 mg of propranolol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubles weekly up to a maximum of 360 mg propranolol daily
16320830|NCT00493467|Drug|Ibritumomab Tiuxetan (Zevalin)|"111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.
~90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8."
16320831|NCT00493467|Drug|Rituximab|250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8.
16320832|NCT00493454|Drug|Zevalin|.3 mCi IV Over 10 Minutes x 1 Day
16320833|NCT00493454|Drug|Rituximab|250 mg/m^2 IV Over 6 to 8 Hours
16320834|NCT00493454|Drug|^111 In Ibritumomab Tiuxetan|1.6 mg IV Over 10 Minutes x 1 Day
16320835|NCT00493441|Drug|AVN944|150, 200, 250, 300, or 400 mg q12h
16320836|NCT00493428|Drug|Baclofen|Patients will receive an initial dose of: 5 mg tid to be increased as tolerated to a maximum dose of 20 mg qid. This dose range and schedule reflects that suggested for the drug's muscle relaxant properties in human.
16320837|NCT00493415|Drug|nitroglycerin iv|loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes
16320838|NCT00493415|Drug|placebo = nacl 0.9%|4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
16320839|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
16320840|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
16320841|NCT00493402|Procedure|Transarterial chemoembolization (TACE)|Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
16320842|NCT00493389|Drug|Adrenocorticotrophic hormone|
16320843|NCT00493376|Procedure|Cervical tissue biopsy analysis: Comet assay|Cervical tissue biopsy analysis: Comet assay
16321346|NCT00489710|Drug|talabostat mesylate|
16320844|NCT00493376|Procedure|Biopsy: Measurement of histone gamma H2AX phosphorylation|Biopsy: Measurement of histone gamma H2AX phosphorylation
16320845|NCT00493376|Procedure|Biopsy: Immunohistochemistry: Ca9, Glut1, HIF-1 alpha|Biopsy: Immunohistochemistry: Ca9, Glut1, HIF-1 alpha
16320846|NCT00493376|Procedure|Measurement of vascular perfusion: contrast enhanced MRI|contrast enhanced MRI
16320847|NCT00493363|Drug|Artesunate|Artesunate 2 mg/kg/day for 7 days
16320848|NCT00493363|Drug|Artesunate + Mefloquine|Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4
16320849|NCT00493350|Procedure|Blood Sample|1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)
16320850|NCT00493337|Behavioral|advanced adherence counseling+reminder|
16320851|NCT00493337|Device|Compliance Card|
16320852|NCT00493324|Drug|alefacept|Intramuscular
16320853|NCT00493324|Drug|polyvalent pneumococcal vaccine|Injection
16320854|NCT00493311|Drug|IV Placebo|IV Placebo
16320855|NCT00493311|Drug|IV Acetaminophen|Intravenous acetaminophen solution 1 g / 100 ml
16320856|NCT00493311|Biological|Reference Standard Endotoxin (RSE)|Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
16320857|NCT00493298|Drug|natalizumab|According to the local prescribing information
16320858|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
16320859|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
16320860|NCT00493285|Biological|MEDI-534|Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
16320861|NCT00493272|Drug|Fibrinogen|Fibrinogen behandling
16320862|NCT00493259|Behavioral|Health-Related Quality of Life instrument|Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome
16320863|NCT00493259|Behavioral|Depression Scale for Children (CES-DC)|questionnaire
16320864|NCT00493246|Drug|IV Acetaminophen|"This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
~Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen"
16320865|NCT00493246|Drug|IV Acetaminophen|"This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
~Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen"
16320866|NCT00493233|Drug|2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)|"Primary antipsychotic medication (olanzapine, oral risperidone, seroquel, clozapine, haldol, perphenazine) will be determined by the treating physician and participants will continue taking the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the second antipsychotic drug will remain fixed throughout the study period."
16320867|NCT00493233|Drug|main antipsychotic medication and placebo|"The main antipsychotic drug will be determined by the treating physician. Participants will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician."
16320868|NCT00493220|Drug|SC HYLENEX and Ceftriaxone|single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
16320869|NCT00493220|Drug|SC Placebo and Ceftriaxone|single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
16320870|NCT00493220|Drug|IV Ceftriaxone|single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
16320871|NCT00493194|Drug|sirolimus|
16320872|NCT00493194|Drug|cyclosporine|
16320873|NCT00493194|Drug|daclizumab|
16320874|NCT00493181|Drug|Interleukin-11 (IL-11 or Neumega)|10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.
16320875|NCT00493155|Drug|RG1530|Administered po at escalating doses (10 cohorts)
16320876|NCT00493142|Behavioral|Exercise|physical therapy home exercise
16320877|NCT00493129|Drug|Ontak (Denileukin Diftitox)|9 µg/kg by vein Days 1-5 of a 21 day cycle.
16320878|NCT00493116|Drug|Interferon-beta-1a|dosage and frequency as per Biogen Idec protocol
16320879|NCT00493116|Drug|methylprednisolone|dosage and frequency as per Biogen Idec protocol
16320880|NCT00493090|Behavioral|modification of an interactive seminar|
16320881|NCT00493077|Drug|low immunogenic interferon-beta-1a|dosage and frequency as per Biogen Idec protocol
16320882|NCT00493064|Drug|Nicotinic acid|topical eye drops
16320883|NCT00493064|Drug|Prednisolone acetate|topical eye drops
16320884|NCT00493051|Biological|GAM501|Ad5PDGF-B formulated in a collagen gel
16320885|NCT00493051|Biological|Placebo|Collagen gel
16320886|NCT00493051|Other|Standard of care|moist dressing changes daily
16320887|NCT00493038|Drug|Moxifloxacin (Avelox, BAY12-8039)|Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
16320888|NCT00493038|Drug|Amoxicillin/Clavulanate|Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
16320889|NCT00493025|Drug|cisplatin|Cisplatin IV
16320890|NCT00493025|Drug|gefitinib|Gefitinib IV
16320891|NCT00493025|Drug|paclitaxel|Paclitaxel IV
16320892|NCT00493025|Procedure|adjuvant therapy|Postoperative ZD1839
16320894|NCT00493012|Dietary Supplement|vitamin D|6 drops of a vitamin D containing oil
16320895|NCT00492999|Drug|dexamethasone|Given by hepatic arterial infusion
16320896|NCT00492999|Drug|floxuridine|Given by hepatic arterial infusion
16320897|NCT00492999|Drug|fluorouracil|Given IV
16320898|NCT00492999|Drug|irinotecan hydrochloride|Given IV
16320899|NCT00492999|Drug|leucovorin calcium|Given IV
16320900|NCT00492999|Drug|oxaliplatin|Given IV
16320901|NCT00492986|Drug|Nexavar (Sorafenib, BAY43-9006)|Multikinase inhibitor: Sorafenib mono therapy 400 mg bid
16320902|NCT00492973|Drug|methylprednisolone acetate|Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
16320903|NCT00492973|Drug|active comparator|bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
16320904|NCT00492960|Drug|larazotide acetate|gelatin capsules
16320905|NCT00492960|Drug|placebo|gelatin capsules
16320906|NCT00492960|Dietary Supplement|900 mg gluten|gelatin capsules
16320907|NCT00492947|Biological|dendritic cell vaccine|3 vaccinations total: Day 10, Day 20, Day 30
16320908|NCT00492934|Drug|human menopausal gonadotrophins|Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation
16320909|NCT00492921|Drug|Cyclophosphamide|
16320910|NCT00492908|Device|Helistent Titan2 (Titanium coated stent)|Titan2
16320911|NCT00492908|Device|EndeavorTM (Zotarolimus-Eluting Stent)|Endeavor
16320912|NCT00492895|Drug|Discontinuation of Azathioprin|Discontinuation of Azathioprin
16320913|NCT00492882|Drug|usual administration of exogenous recombinant FSH|
16320914|NCT00492869|Drug|AEB071|
16320915|NCT00492856|Drug|mercaptopurine|Given orally
16320916|NCT00492856|Drug|methotrexate|Given orally
16320917|NCT00492856|Drug|tretinoin|Given orally
16320918|NCT00492843|Drug|Ibandronate (Bondronat)|Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
16320919|NCT00492830|Drug|TRC093 recombinant humanized IgG1k monoclonal antibody|TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops.
16320920|NCT00492817|Procedure|Stereotactic Body Radiotherapy|On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
16320921|NCT00492804|Procedure|Lichtenstein hernia repair|Lichtenstein hernia repair with tension free mesh
16320922|NCT00492804|Procedure|Neurectomy|Neurectomy
16320923|NCT00492791|Device|wireless endoscopy capsule|Firslty patency ingestion then wireless endoscopy capsule exam done
16320924|NCT00492778|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-dimensional conformal radiation therapy
16320925|NCT00492778|Drug|Cisplatin|Given IV
16320926|NCT00492778|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16320927|NCT00492778|Radiation|Internal Radiation Therapy|Given intracavitarily or interstitially
16320928|NCT00492765|Drug|Interferon-beta-1a|dosage and frequency as per label
16320929|NCT00492765|Drug|Simvastatin|dosage and frequency as per Biogen Idec protocol
16320930|NCT00492765|Drug|Placebo|dosage and frequency the same as simvastatin as per Biogen Idec Protocol
16320931|NCT00492752|Drug|Sorafenib (Nexavar, BAY43-9006)|multikinase inhibitor; Sorafenib 400 mg (orally) twice daily
16320932|NCT00492752|Drug|Placebo|Matching placebo (orally) twice daily
16320933|NCT00492739|Biological|Vaccination with VZV vaccine|Varicella vaccination 2 doses 2 months apart.
16320934|NCT00492726|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin, 400mg, administered intravenously once daily
16320935|NCT00492726|Drug|Ertapenem intravenous|Active treatment: Ertapenem 1.0g, administered intravenously once daily
16320936|NCT00492713|Other|dark chocolate|dark chocolate
16320937|NCT00492713|Other|Milk chocolate 1|Milk chocolate 1
16320938|NCT00492713|Other|Milk chocolate 2|Milk chocolate 2
16320939|NCT00492700|Drug|rosiglitazone|
16320940|NCT00492687|Drug|carboplatin|
16320941|NCT00492687|Drug|tamoxifen citrate|
16320942|NCT00492687|Drug|temozolomide|
16320943|NCT00492687|Procedure|adjuvant therapy|
16320944|NCT00492687|Radiation|radiation therapy|
16320945|NCT00492674|Device|APOS biomechanical gait system|
16320946|NCT00492674|Procedure|Physical Therapy|
16320947|NCT00492661|Drug|Tacrolimus With Diet and Exercise Intervention|Participants on tacrolimus for immunosuppression will be provided with intensive dietary advice and supervised for a period of 6 months. Dosage and administration of tacrolimus will be as per Investigator's discretion.
16320948|NCT00492648|Procedure|Blood sampling for assay of persistence of immunogenicity|Two blood samples: 30 and 42 months after first vaccination
16320949|NCT00492635|Drug|Levitra (Vardenafil, BAY38-9456)|9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
16320950|NCT00492635|Drug|Levitra (Vardenafil, BAY38-9456)|9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
16320951|NCT00492635|Drug|Placebo|9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
16320952|NCT00492622|Drug|Immediate-release omeprazole|Immediate-release omeprazole 40 mg qam for 7 days
16320953|NCT00492622|Drug|Delayed-release omeprazole|Delayed-release omeprazole 40 mg qam for 7 days
16320954|NCT00492596|Device|AttenueX IntraVesical System|Insertion of the Solace AttenueX Intravesical System on Day 0
16320955|NCT00492596|Procedure|Sham Procedure|Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
16321022|NCT00492232|Drug|Ramelteon and zolpidem|Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
16321023|NCT00492232|Drug|Placebo and zolpidem|Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
16320956|NCT00492583|Drug|Bifidobacterium lactis (BB-12)|The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).
16320957|NCT00492583|Drug|Placebo|The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
16320958|NCT00492557|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.
16320959|NCT00492557|Biological|13vPnC + TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.
16320960|NCT00492544|Biological|Cervarix™ (HPV-16/18 L1 VLP AS04)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16320961|NCT00492531|Drug|Sildenafil|Oral Sildenafil 20mg three times daily for 6 weeks,followed by 40mg three times daily for 4 weeks followed by 80mg three times daily for 6 weeks.
16320962|NCT00492531|Drug|Placebo|Placebo 20mg three times daily for 6 weeks,followed by 40mg three times daily for 4 weeks followed by 80mg three times daily for 6 weeks.
16320963|NCT00492518|Drug|Acetylcysteine|
16320964|NCT00492518|Drug|Theophylline|
16320965|NCT00492518|Drug|Placebo|
16320966|NCT00492505|Drug|cisplatin|
16320967|NCT00492505|Drug|sorafenib tosylate|
16320968|NCT00492505|Drug|tamoxifen citrate|
16320969|NCT00492505|Procedure|adjuvant therapy|
16320970|NCT00492492|Procedure|trans-styloid and intrafocal pinning on the one side|
16320971|NCT00492492|Procedure|volar fixed-angle plating on the other side|
16320972|NCT00492479|Drug|Kinerase Pro+Therapy Line day repair, serum, night repair|
16320973|NCT00492479|Drug|Kinerase Pro+Therapy Line Ultra rich day repair|
16320974|NCT00492479|Drug|LubriDerm|
16320975|NCT00492466|Drug|Interferon-beta-1a|dosage and frequency as per label
16320976|NCT00492466|Drug|methylprednisolone|dosage and frequency as per Biogen Idec protocol
16320977|NCT00492453|Procedure|laparoscopic cholecystectomy|elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
16320978|NCT00492440|Biological|recombinant interleukin-7|
16320979|NCT00492440|Genetic|gene expression analysis|
16320980|NCT00492440|Genetic|polymerase chain reaction|
16320981|NCT00492440|Genetic|protein expression analysis|
16320982|NCT00492440|Other|flow cytometry|
16320983|NCT00492440|Other|immunoenzyme technique|
16320984|NCT00492440|Other|immunologic technique|
16320985|NCT00492440|Other|laboratory biomarker analysis|
16320986|NCT00492440|Other|pharmacological study|
16320987|NCT00492427|Drug|R744|25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25~250μg(s.c.)/4week for 24~26weeks in total.
16320988|NCT00492427|Drug|Epoetin beta|6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k~12000IU(s.c.)/2week for 24~26weeks in total.
16320989|NCT00492414|Drug|Paroxetine CR|
16320990|NCT00492401|Drug|decitabine|Given IV
16320991|NCT00492401|Other|laboratory biomarker analysis|Correlative studies
16320992|NCT00492401|Other|pharmacological study|Correlative studies
16320993|NCT00492401|Other|high performance liquid chromatography|Correlative studies
16320994|NCT00492401|Genetic|microarray analysis|Correlative studies
16320995|NCT00492401|Genetic|RNA analysis|Correlative studies
16320996|NCT00492401|Other|mass spectrometry|Correlative studies
16320997|NCT00492401|Genetic|DNA methylation analysis|Correlative studies
16320998|NCT00492401|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|Correlative studies
16320999|NCT00492388|Drug|PMI-150 (intranasal ketamine)|intranasal dosing
16321000|NCT00492388|Drug|placebo|placebo
16321001|NCT00492362|Behavioral|ergometer exercise during hemodialysis|
16321002|NCT00492362|Behavioral|pedometer activity outside of hemodialysis|
16321003|NCT00492349|Drug|Varenicline|Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
16321004|NCT00492349|Drug|Placebo|Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
16321005|NCT00492336|Drug|rasagiline (Pharmacodynamics)|Rasagiline 1 mg/day for 12 weeks
16321006|NCT00492336|Drug|Placebo|Placebo 1 tablet each day
16321007|NCT00492323|Drug|placebo|twice daily for 4 weeks
16321008|NCT00492323|Drug|carisbamate|200 mg tablet twice daily for 4 weeks
16321009|NCT00492310|Behavioral|yoga|vinyasa yoga
16321010|NCT00492310|Behavioral|cognitive therapy|cognitive behavioral therapy once weekly
16321011|NCT00492310|Behavioral|yoga|vinyasa yoga twice weekly with smoking cessation once weekly
16321012|NCT00492310|Behavioral|wellness|wellness program with smoking cessation
16321013|NCT00492297|Drug|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
16321014|NCT00492284|Drug|verteporfin|Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
16321015|NCT00492284|Drug|verteporfin|Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
16321016|NCT00492284|Drug|ranibizumab|0.5 mg intravitreal injection
16321017|NCT00492284|Drug|dexamethasone|0.5 mg intravitreal injection
16321018|NCT00492271|Drug|Friulimicin B|Intravenous, once daily, single dose
16321019|NCT00492258|Drug|sorafenib tosylate|
16321020|NCT00492258|Procedure|adjuvant therapy|
16321021|NCT00492245|Procedure|PTK with mitomycin in Adenoviral Opacities|
16321076|NCT00491855|Drug|Bevacizumab|Starting dose level 2.5 mg/kg given intravenously on day 1.
16321024|NCT00492219|Device|Vanguard M fixed-bearing or Oxford mobile-bearing prostheses|Patients that are appropriate for partial knee replacement will be randomized to receive one of these two FDA-approved implant systems.
16321025|NCT00492219|Device|Total Knee Replacement|Patients undergoing total knee replacement with the Vanguard Complete Knee implant system
16321026|NCT00492206|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.
16321027|NCT00492167|Biological|beta-glucan|
16321028|NCT00492167|Biological|monoclonal antibody 3F8|
16321029|NCT00492167|Other|immunohistochemistry staining method|
16321030|NCT00492167|Other|laboratory biomarker analysis|
16321031|NCT00492141|Drug|Temozolomide|Cycle 2, Dose Level 1 = 100 mg/m^2 by mouth (PO) Daily, Days 1-5 Prior to L9-NC; Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, advance to 100 mg/m^2 PO Every 12 Hours, Days 1-5 Prior to L9-NC. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2; Cycle 4 and beyond = Patients will continue on dose level 1 or 2 as given in cycle 3.
16321032|NCT00492141|Drug|L9-NC|"Cycle 1 = Administered by aerosol 5 consecutive days per week for 2 weeks. A total of 10 ml of 0.4 mg/ml in an aerosol reservoir delivered over approximately 30 minutes per day given once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
~Cycle 2, Dose Level 1 = Week 1, doses 1-5 preceded by temozolomide. Continue L9-NC once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
~Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, due to drug, during cycle 2, L9-NC may be increased to twice daily, approximately 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given twice a day, 5 days a week, for 2 weeks, followed by 2 weeks off. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2.
~Cycle 4 and beyond, patients will continue on dose level 1 or 2 as given in cycle 3."
16321033|NCT00492128|Drug|Losartan/amlodipine or losartan/hydrochlorothiazide|Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.
16321034|NCT00492115|Device|Continuous positive airway pressure (CPAP)|therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks
16321035|NCT00492115|Device|Placebo CPAP|Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks
16321036|NCT00492102|Drug|Montelukast|One oral dose of Montelukast 0.15mg (infants weighing 500-1000gm) or 0.2mg (infants weighing >1000gm). Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.
16321037|NCT00492089|Drug|bevacizumab|Given IV
16321038|NCT00492089|Drug|placebo|Given IV
16321039|NCT00492089|Procedure|magnetic resonance imaging|
16321040|NCT00492089|Procedure|quality-of-life assessment|
16321041|NCT00492076|Biological|Pangramin Plus D. pteronyssinus 100%|"Active. Pangramin Plus D. pteronyssinus 100%
~Placebo. Pangramin Plus placebo"
16321042|NCT00492063|Biological|Cell culture-derived trivalent subunit influenza vaccine (cTIV)|One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
16321043|NCT00492063|Biological|Egg-derived trivalent subunit influenza vaccine (TIV)|One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
16321044|NCT00492050|Drug|Bortezomib|1.6 mg/m^2 IV Weekly on Days 1, 8, 15 and 22.
16321045|NCT00492050|Drug|Rituximab|375 mg/m^2 IV on Day 8 and 22.
16321046|NCT00492050|Drug|Valacyclovir|500 mg orally daily (or acyclovir 200 mg orally twice daily)
16321047|NCT00492037|Drug|YM087 oral|
16321048|NCT00492024|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin - 400 mg once a day for 5 days
16321049|NCT00492024|Drug|Placebo|Placebo - 380 mg Microcrystalline Cellulose
16321050|NCT00492011|Drug|Ramelteon|Ramelteon 1 mg, tablets, orally, once nightly for 4 nights.
16321051|NCT00492011|Drug|Ramelteon|Ramelteon 4 mg, tablets, orally, once nightly for 4 nights.
16321052|NCT00492011|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once nightly for 4 nights.
16321053|NCT00492011|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for 4 nights.
16321054|NCT00491998|Drug|V1512|6 doses of IMP at 2-hourly intervals
16321055|NCT00491998|Drug|V1512|3-hourly dosing
16321056|NCT00491998|Drug|V1512 and Entacapone|4 doses of IMP and Entacapone at 3-hourly intervals
16321057|NCT00491985|Biological|A/H5N1 Inactivated, split-virion pandemic influenza vaccine|0.5 mL, Intramuscular
16321058|NCT00491985|Biological|A/H5N1 Inactivated, split virion pandemic influenza vaccine|0.5 mL, Intramuscular
16321059|NCT00491985|Biological|A/H5N1 Inactivated, split virion pandemic influenza vaccine|0.25 mL, Intramuscular
16321060|NCT00491959|Procedure|Cultured oral mucosa cell sheet transplantation|Cultivated oral mucosal cell sheets will be transplanted on the denuded corneal surface or the scleral surface of the symblepharon area. Therapeutic contact lenses will be applied after surgery.
16321061|NCT00491946|Drug|Actinomycin-D|
16321062|NCT00491946|Drug|Vincristine|
16321063|NCT00491933|Procedure|Quantiferon-TB Gold assay|
16321064|NCT00491933|Procedure|Tuberculin skin test|
16321065|NCT00491920|Drug|cholecalciferol (Vitamin D3)|"20 000 Iu x2/week
~+ calcium 500 mg/cholecalciferol 400 IU x2/d"
16321066|NCT00491920|Drug|placebo|Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
16321067|NCT00491907|Drug|folic acid 5mg/day|
16321068|NCT00491894|Drug|Oral Glycopyrrolate Liquid|Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver
16321069|NCT00491881|Behavioral|no added salt diet|
16321070|NCT00491868|Drug|R744|100μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
16321071|NCT00491868|Drug|R744|150μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
16321072|NCT00491868|Drug|rHuEPO|2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
16321073|NCT00491868|Drug|rHuEPO|4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
16321074|NCT00491868|Drug|R744 placebo|0 μg/4week for 24 weeks
16321075|NCT00491868|Drug|rHuEPO placebo|0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
16321077|NCT00491855|Drug|Oxaliplatin|Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
16321078|NCT00491855|Drug|Paclitaxel|Starting dose level 110 mg/m^2 given continuous infusion on day 1 and 30 mg/m^2 given intraperitoneally on day 8.
16321079|NCT00491829|Drug|50 mg qhs|flibanserin 50 mg
16321080|NCT00491829|Drug|100 mg|flibanserin 100mg
16321081|NCT00491829|Drug|placebo|placebo
16321082|NCT00491816|Drug|Erlotinib with neoadjuvant chemotherapy|150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
16321083|NCT00491803|Drug|Sildenafil|sildenafil 20 mg orally
16321084|NCT00491803|Drug|Sildenafil|sildenafil 40 mg orally
16321085|NCT00491790|Drug|Montelukast|Montelukast 4 mg rapid dissolving granules in sterile water given orally once
16321086|NCT00491790|Other|Sterile water|Sterile water
16321087|NCT00491777|Device|Noninvasive Hemodynamic Patient Monitor|
16321088|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
16321089|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
16321090|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
16321091|NCT00491764|Drug|SCH 56592|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
16321092|NCT00491764|Drug|Terbinafine|Terbinafine 250 mg QD for 12 weeks.
16321093|NCT00491764|Drug|Placebo|Placebo for 24 weeks.
16321094|NCT00491751|Drug|atorvastatin|atorvastatin 40 or 80 mg/day
16321095|NCT00491751|Drug|ascorbic acid|ascorbic acid 500 mg/day
16321096|NCT00491751|Drug|Placebo|matching placebo
16321097|NCT00491738|Drug|bevacizumab|Intravenous repeating dose
16321098|NCT00491738|Drug|sunitinib|Oral repeating dose
16321099|NCT00491738|Drug|placebo|Intravenous repeating dose
16321100|NCT00491725|Drug|repaglinide|
16321101|NCT00491725|Drug|metformin|
16321102|NCT00491712|Procedure|Glaucoma drainage implant with/without triamcinolone|
16321103|NCT00491699|Drug|XL999|XL999 will be administered as a once-weekly 4 hour IV infusion as a single agent. The first cohort will be dosed at 0.4 mg/kg IV once weekly. The maximum dose cohort will not exceed 1.6 mg/kg IV once weekly. Ten subjects are planned for each dosing cohort, with dose escalation dependent on safety and available PK data from prior cohorts
16321104|NCT00491686|Drug|AZD6765|intravenous infusion
16321105|NCT00491673|Procedure|Uncemented primary bipolar hemiarthroplasty of the hip|Uncemented primary bipolar hemiarthroplasty of the hip
16321106|NCT00491673|Procedure|Cemented primary bipolar hemiarthroplasty of the hip|Cemented primary bipolar hemiarthroplasty of the hip
16321107|NCT00491660|Behavioral|supine positioning|
16321108|NCT00491660|Behavioral|lateral positioning|
16321109|NCT00491634|Drug|treosulfan|12 g/m2 x 3 days
16321110|NCT00491634|Drug|Treosulfan|12 g/m2 x 3
16321111|NCT00491621|Procedure|surgery or biopsy of the kidney tumor|surgery or biopsy of the kidney tumor
16321112|NCT00491608|Biological|rThrombin|1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder
16321113|NCT00491595|Drug|High Dose Soy isoflavones|
16321114|NCT00491582|Drug|Growth hormone replacement therapy in growth hormone deficient patients only.|Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months
16321115|NCT00491569|Drug|Sarcosine and D-serine|
16321116|NCT00491556|Procedure|Early Initiation of Highly Active Anti-Retroviral Therapy|Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
16321117|NCT00491556|Procedure|Standard Care|Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
16321118|NCT00491543|Drug|ALT-2074|
16321119|NCT00491530|Drug|ABT-335|Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
16321120|NCT00491530|Drug|rosuvastatin calcium|Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
16321121|NCT00491530|Drug|simvastatin|Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
16321122|NCT00491530|Drug|atorvastatin calcium|Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
16321123|NCT00491517|Drug|Sirolimus|Patients will be given Sirolimus starting at the oral daily dose of 3 mg with periodically whole blood level measurements. The daily dose will be adjusted to keep sirolimus concentration within 10-15 ng/ml.
16321124|NCT00491517|Drug|conventional therapy|Antihypertensive drugs for patients with high blood pressure.
16321125|NCT00491504|Drug|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
16321126|NCT00491504|Other|Placebo|Placebo: 2 sprays in each nostril
16321127|NCT00491491|Drug|ibritumomab tiuxetan|0.4 mCi/kg
16321128|NCT00491491|Procedure|BEAM chemotherapy and autologous stem-cell transplantation|
16321129|NCT00491478|Drug|sertraline|
16321130|NCT00491465|Behavioral|Intensive Physical activity|
16321131|NCT00491465|Behavioral|Control- regular physical activity|
16321132|NCT00491426|Drug|Ampicillin|Drug prescribed per routine medical care.
16321133|NCT00491426|Drug|Metronidazole|Drug prescribed per routine medical care.
16321134|NCT00491426|Drug|Piperacillin/Tazobactam|Drug prescribed per routine medical care.
16321135|NCT00491426|Drug|Acyclovir|Drug prescribed per routine medical care.
16321339|NCT00489775|Drug|Duloxetine|
16321136|NCT00491426|Drug|Amphotericin B|Drug prescribed per routine medical care.
16321137|NCT00491426|Drug|Ambisome|Drug prescribed per routine medical care.
16321138|NCT00491426|Drug|Anidulafungin|Drug prescribed per routine medical care.
16321139|NCT00491426|Drug|Caspofungin|Drug prescribed per routine medical care.
16321140|NCT00491413|Drug|epoetin|
16321141|NCT00491400|Drug|Fenofibrate|140 mg/day for 8 weeks
16321142|NCT00491400|Drug|Atorvastatin|20 mg/day for 8 weeks
16321143|NCT00491387|Drug|Metoprolol Succinate|Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.
16321144|NCT00491374|Drug|Mometasone Furoate Nasal Spray|Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.
16321145|NCT00491374|Drug|Placebo|Placebo Nasal Spray 4 sprays once daily every morning for 28 days.
16321146|NCT00491348|Drug|duloxetine hydrochloride|duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
16321147|NCT00491322|Dietary Supplement|Ergocalciferol|Ergocalciferol 50000 international units once a week for 12 weeks
16321148|NCT00491322|Dietary Supplement|Ergocalciferol placebo|Ergocalciferol placebo once a week for 12 weeks
16321149|NCT00491309|Behavioral|exercise training|exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
16321150|NCT00491296|Device|SYNERGO|
16321151|NCT00491296|Device|SYNERGO-intravesical chemotherapy instillation combined with hyperthermia|
16321152|NCT00491283|Device|Swab Specimen Collection (QuickVue)|
16321153|NCT00491270|Device|VS Sense|An applicator to diagnose pH increase above 5.2
16321154|NCT00491257|Biological|Inactivated influenza vaccine (split virion) NH 2007-2008 formulation|0.5 mL, Intramuscular
16321155|NCT00491244|Drug|Peginterferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
16321156|NCT00491244|Drug|Peginterferon alfa-2a|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
16321157|NCT00491192|Drug|Diclofenac|
16321158|NCT00491179|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
16321159|NCT00491179|Drug|Pegylated interferon alfa-2a and ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
16321160|NCT00491166|Drug|Bromfenac ophthalmic solution|
16321161|NCT00491140|Genetic|Gene mutations analysis and FISH|FISH and mutation analysis of multiple genes
16321162|NCT00491127|Drug|gemcitabine|
16321163|NCT00491127|Drug|cisplatin|
16321164|NCT00491127|Drug|dexamethasone|
16321165|NCT00491114|Drug|Gemcitabine|
16321166|NCT00491101|Other|Polish Version of PAQLQ(S) by Juniper|Polish Version of PAQLQ(S) by Juniper
16321167|NCT00491101|Other|spirometry|spirometry
16321168|NCT00491088|Device|CPAP|CPAP for 12 weeks
16321169|NCT00491075|Drug|Pemetrexed|500 mg/m^2 IV Over 10 Minutes on Day 1.
16321170|NCT00491075|Drug|Gemcitabine|1500 mg/m^2 IV Over 30 Minutes on Day 1, Immediately After Infusion of Pemetrexed.
16321171|NCT00491062|Procedure|Biopsies|
16321172|NCT00491049|Drug|0.5% levofloxacin eye drops|
16321173|NCT00491036|Device|Intraaortic balloon pump|intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
16321174|NCT00491010|Procedure|radiofrequency catheter ablation|
16321175|NCT00490997|Drug|Ketamine only|"Ketamine 1.0 mg/kg IV and placebo intralipid as initial sedation agents (double blinded).
~Ketamine .25 mg/kg IV and placebo intralipid q2 minutes prn for additional sedation"
16321176|NCT00490997|Drug|Ketamine - Propofol|"Ketamine .5 mg/kg and Propofol 1 mg/kg as initial sedation agents (double-blinded).
~Saline Placebo and Propofol .5 mg/kg q 2minutes for additional sedation"
16321177|NCT00490984|Device|Aspire Medical Advance System|The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
16321178|NCT00490971|Drug|Olanzapine|Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence
16321179|NCT00490971|Drug|Paliperidone ER|Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence
16321180|NCT00490971|Drug|Placebo|Once daily until recurrence (only after initial 15 weeks on paliperidone ER)
16321181|NCT00490958|Drug|telmisartan|
16321182|NCT00490945|Drug|VEC-162|
16321183|NCT00490932|Drug|Hypo-osmolar ORS|
16321184|NCT00490919|Drug|Buprenorphine transdermal system|Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
16321185|NCT00490919|Drug|Placebo|transdermal system (placebo) worn for 7 days
16321186|NCT00490906|Drug|Copaxone|20 mg, subcutaneous injections, taken daily
16321187|NCT00490906|Drug|Interferon-beta 1a|30 mcg injected intramuscularly, once weekly
16321188|NCT00490906|Drug|Interferon-beta 1b|.25 mg/day, taken every other day, subcutaneous injections
16321189|NCT00490893|Drug|Detemir|
16321190|NCT00490880|Drug|gemcitabine|
16321191|NCT00490880|Drug|cisplatin|
16321192|NCT00490880|Procedure|radical cystectomy|
16321193|NCT00490880|Procedure|radiotherapy|
16321194|NCT00490867|Drug|Alpha lipoic acid|
16321195|NCT00490854|Drug|Human Insulin Inhalation Powder|patient specific, inhaled, at meals, 76 weeks
16321196|NCT00490854|Drug|Neutral protamine hagedorn insulin|patient specific dose, injected, daily, 76 weeks
16321197|NCT00490841|Device|Herculink Elite Renal Stent System|This is a prospective, non-randomized, single arm, multi-center study to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with sub-optimal renal PTA results in de novo or restenotic renal artery lesions. Patients who satisfy the inclusion/exclusion criteria will be enrolled at sites in the United States. Patients will have follow up visits for evaluation.
16321198|NCT00490828|Drug|Hydrocortisone|Hydrocortisone
16321199|NCT00490815|Drug|Fluocinolone Acetonide|0.5 mg fluocinolone acetonide intravitreal insert
16321200|NCT00490815|Drug|Fluocinolone Acetonide|0.2 mg fluocinolone acetonide intravitreal insert
16321201|NCT00490802|Drug|Oxytocin|Intranasal Oxytocin
16321202|NCT00490802|Drug|Placebo|Placebo Comparator
16321203|NCT00490789|Drug|sirolimus|daily oral sirolimus with dosage individualised by trough blood levels
16321204|NCT00490776|Drug|Panobinostat|Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.
16321205|NCT00490763|Behavioral|Survey|7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life.
16321206|NCT00490750|Procedure|Dor fundoplication|Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
16321207|NCT00490750|Procedure|Toupet fundoplication|Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication
16321208|NCT00490737|Drug|daptomycin|6mg/kg, i.v. infusion over 30 minutes; every 48 hours for a total of 3 doses
16321209|NCT00490724|Drug|Nesiritide (1+0.01)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg.
16321210|NCT00490724|Drug|Nesiritide (2+0.005)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg.
16321211|NCT00490724|Drug|Nesritide (2+0.01)|Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg.
16321212|NCT00490711|Drug|gemcitabine|
16321213|NCT00490711|Drug|carboplatin|
16321214|NCT00490711|Drug|paclitaxel|
16321215|NCT00490698|Drug|Zoledronate|4 mg IV Once Every 4 Weeks
16321216|NCT00490698|Drug|Atorvastatin|20 mg PO Daily
16321217|NCT00490685|Drug|Sorafenib (BAY-43-9006)|
16321218|NCT00490672|Behavioral|No Active Intervention.|Conventional Chronic Disease Management in Malaysia Primary Care
16321219|NCT00490672|Behavioral|Community Based Multiple Risk Factor Intervention Strategies|Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.
16321220|NCT00490659|Drug|gemcitabine|
16321221|NCT00490659|Drug|cisplatin|
16321222|NCT00490659|Procedure|radical surgery|
16321223|NCT00490659|Procedure|chemoradiotherapy|
16321224|NCT00490646|Drug|ixabepilone|"Ixabepilone 40 mg/m^2 was administered as a 3-hour I.V. continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity.
~For the first cycle, ixabepilone was administered the day following the first dose of trastuzumab (in the first cycle trastuzumab was given on Day 0); in all the following cycles, ixabepilone was administered immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated."
16321225|NCT00490646|Drug|docetaxel|Docetaxel 100 mg/m^2 was administered as a 1-hour IV continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity. For the first cycle, docetaxel was administered the day following the first dose of trastuzumab (i.e. in the first cycle trastuzumab was given on Day 0); in all following cycles, docetaxel was administered immediately after trastuzumab if the preceding dose of trastuzumab was well tolerated.
16321226|NCT00490646|Drug|trastuzumab|Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.
16321227|NCT00490633|Behavioral|Ear Loop Procedure Mask|Facemasks were requested to be worn while participants were in the residence hall for year one, and while they were in residence halls for a minimum of six hours per day in year two.
16321228|NCT00490633|Behavioral|62% Ethyl Alcohol Hand Sanitizer|Hand sanitizer was provided to participants in the facemask and hand hygiene arm for year one and year two of the study.
16321229|NCT00490620|Drug|Combination antiviral therapy|Zidovudine 300mg and lamivudine 150mg BID for 6 months
16321230|NCT00490620|Drug|Placebo|placebo BID for 6 months
16321231|NCT00490594|Device|ACL Reconstruction (SeriACL™ Device)|Bioresorbable ACL
16321232|NCT00490581|Other|case management and supportive housing|patients randomized to the study group are offerred respite care/interim housing and case management upon discharge from enrolling hospitalization. They are also offerred stable housing within 90 days of enrolling hospital discharge, with case management at all 3 stages - hospital, respite care/interim housing, and stable housing.
16321233|NCT00490568|Drug|Rosiglitazone XR|Experimental drug
16321234|NCT00490555|Drug|Testosterone gel|Testosterone gel 10 g
16321235|NCT00490555|Drug|Dutasteride|dutasteride 0.5 mg orally
16321236|NCT00490555|Drug|Depo-Medroxyprogesterone (DMPA)|300 mg DMPA injection on Day 0 IM (into the muscle)
16321237|NCT00490555|Other|Placebo Testosterone gel|Place gel applied daily for 12 weeks
16321238|NCT00490555|Other|Placebo dutasteride|placebo pill for 12 weeks
16321239|NCT00490555|Other|Placebo DMPA|placebo DMPA injection Once
16321240|NCT00490542|Drug|ziprasidone (Geodon)|ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.
16321241|NCT00490542|Drug|placebo|Placebo, sugar pill arm. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.
16321340|NCT00489775|Drug|Paroxetine|
16321341|NCT00489762|Procedure|Installation of an energy efficient heater|
16321242|NCT00490529|Biological|CpG-MCL vaccine|CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.
16321243|NCT00490529|Biological|PF-3512676|PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.
16321244|NCT00490529|Procedure|Vaccine-primed T-cells|Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.
16321245|NCT00490529|Procedure|Autologous hematopoietic stem cell transplant (HSCT)|Regular medical procedure
16321246|NCT00490529|Drug|Rituximab|375 mg/m² by infusion
16321247|NCT00490529|Drug|Standard induction chemotherapy|Patient-specific, regular medical care treatment as determined by treating oncologist
16321248|NCT00490529|Drug|Cyclophosphamide|Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
16321249|NCT00490529|Drug|Filgrastim|Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
16321250|NCT00490516|Drug|ACP-104|200 mg, tablet, BID, 6 weeks
16321251|NCT00490516|Drug|ACP-104|100 mg, tablet, BID, 6 weeks
16321252|NCT00490516|Drug|Placebo|placebo, tablet BID, 6 weeks
16321253|NCT00490503|Procedure|Magnetic Resonance Imaging (MRI)|3 Scans performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
16321254|NCT00490503|Procedure|Magnetic Resonance Spectroscopy (MRS)|3 MRI Scans with MRS performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
16321255|NCT00490490|Drug|Bexxar (tositumomab)|Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.
16321256|NCT00490490|Procedure|External beam radiotherapy (XRT)|Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.
16321257|NCT00490490|Drug|Potassium Iodide (KI)|"Potassium iodide (KI) will be administered as:
~Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,
~Lugol's solution 20 drops orally 3-times-a-day, OR
~KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab"
16321258|NCT00490477|Device|Polymyxin -B fiber hemoperfusion system|two hours treatment for two days
16321259|NCT00490464|Drug|Nicardipine and Nipride|
16321260|NCT00490451|Drug|LY573636-sodium|LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
16321261|NCT00490425|Drug|Lactobacillus rhamnosus strain GG ATCC 53103 (LGG, 1010 cfu)|
16321262|NCT00490412|Dietary Supplement|Vitamin D supplement|Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
16321263|NCT00490412|Other|Placebo|A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
16321264|NCT00490399|Drug|gemcitabine|
16321265|NCT00490399|Drug|cisplatin|
16321266|NCT00490373|Drug|pemetrexed|
16321267|NCT00490360|Drug|Gemcitabine / Cisplatin|
16321268|NCT00490347|Device|VentrAssist Left Ventricular Assist Device|
16321269|NCT00490321|Device|VentrAssistTM Left Ventricular Assist Device|
16321270|NCT00490308|Drug|Treatment with estradiol valerate|
16321271|NCT00490282|Radiation|Intensity Modulated Radiation Therapy|IMRT Treatment Over 6-7 Weeks
16321272|NCT00490282|Radiation|Adaptive Radiotherapy|ART Treatment Over 6-7 Weeks
16321273|NCT00490269|Drug|Placebo|
16321274|NCT00490269|Drug|Dronabinol|
16321275|NCT00490256|Procedure|Modified Selective Cerebral Perfusion|Modified Selective perfusion is a cardiopulmonary bypass circuit that has been modified to allow blood flow to the lower body as well as the upper body while the surgery is being performed.
16321276|NCT00490243|Drug|budesonide and montelukast|
16321277|NCT00490243|Drug|budesonide and formoterol|
16321278|NCT00490243|Drug|montelukast|
16321279|NCT00490243|Drug|budesonide|
16321280|NCT00490243|Drug|placebo|
16321281|NCT00490230|Drug|WR 279396|
16321282|NCT00490204|Drug|Cetirizine|
16321283|NCT00490191|Drug|Somatropin|
16321284|NCT00490178|Drug|Fenofibrate 80 mg and metformin 1000 mg (fixed combination)|
16321285|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
16321286|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
16321342|NCT00489749|Procedure|Protected early weightbearing/Achilles tendon surgery|
16321343|NCT00489736|Drug|dronedarone (SR33589)|oral administration
16321287|NCT00490152|Behavioral|Automated diary system|"Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with Juliana to discuss the product and the technology used in the study. They will also have the opportunity to send emails to Juliana during the course of the study."
16321288|NCT00490139|Drug|Lapatinib|Small molecule inhibitor
16321289|NCT00490139|Biological|Trastuzumab|Antibody
16321290|NCT00490126|Other|Laparoscopic Surgery Data Collection|Prospectively and retrospectively collect data on patients who had laparoscopic surgery since January 1, 1990 forward. Data from the initial patient visit note, consultation notes, operative report, discharge summary, and follow-up progress notes will be entered into the database.
16321291|NCT00490113|Drug|Pyridoxamine|Two 250 mg capsules, or placebo, given twice a day for four, 4 week periods. Subjects with primary hyperoxaluria will aslo receive escalated doses up to 3500 mg/day for up to 6 1/2 days.
16321292|NCT00490100|Drug|Increlex|
16321293|NCT00490087|Device|Levonorgestrel intrauterine device (IUD)|
16321294|NCT00490074|Biological|DNA-C|1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
16321295|NCT00490074|Biological|NYVAC-C|NYVAC-C 1 ml IM
16321296|NCT00490061|Drug|Lapatinib|1500 mg po daily orally
16321297|NCT00490061|Procedure|Radiotherapy (radiation)|Standard of Care
16321298|NCT00490061|Device|G.E. Healthcare 1.5T MR, systems revision 12.0 M5|Standard of Care, used to deliver IMRT
16321299|NCT00490061|Device|DCE-MRI|A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.
16321300|NCT00490048|Procedure|Induced sputum (inhalation of 3.5% saline)|
16321301|NCT00490035|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
16321302|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
16321303|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
16321304|NCT00490035|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
16321305|NCT00490022|Drug|Dihydrotestosterone (DHT) gel (0.7%)|DHT gel, 70 mg/day for one month
16321306|NCT00490022|Drug|Placebo gel|Placebo gel for one month
16321307|NCT00490009|Drug|Bexxar|"Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.
~Bexxar will be administered to provide the following patient-specific radiotherapy:
~Platelet count of 150,000/mm³ = 75 cGy
~Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy"
16321308|NCT00490009|Drug|Acetaminophen|As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
16321309|NCT00490009|Drug|Diphenhydramine|As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
16321310|NCT00490009|Drug|Potassium Iodide (KI)|Administered to prevent thyroid blockage 130 mg orally 3 times a day,
16321311|NCT00489996|Drug|gemcitabine|
16321312|NCT00489996|Drug|cisplatin|
16321313|NCT00489983|Drug|pemetrexed|
16321314|NCT00489983|Drug|gemcitabine|
16321315|NCT00489970|Procedure|Taking of blood samples|No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.
16321316|NCT00489970|Biological|Boostrix|A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
16321317|NCT00489970|Biological|Adacel|A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
16321318|NCT00489944|Drug|cisplatin|
16321319|NCT00489944|Drug|sunitinib malate|
16321320|NCT00489944|Drug|tamoxifen citrate|
16321321|NCT00489944|Procedure|adjuvant therapy|
16321322|NCT00489931|Drug|VRC-AVIDNA036-00-VP|
16321323|NCT00489918|Drug|teriparatide|Macroflux® patch applied to the abdomen for 30 minutes daily
16321324|NCT00489918|Drug|teriparatide|FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
16321325|NCT00489905|Drug|Zolderonic acid (Zometa)|
16321326|NCT00489892|Drug|Modafinil|
16321327|NCT00489879|Device|Mobile Health Care System (DrUB)|
16321328|NCT00489866|Drug|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
16321329|NCT00489866|Drug|Placebo|Same as active drug.
16321330|NCT00489853|Drug|budesonide/formoterol Turbuhaler 320/9µg|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
16321331|NCT00489853|Drug|formoterol Turbuhaler 9µg|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
16321332|NCT00489853|Other|Placebo|Placebo, 1 inhalation twice daily
16321333|NCT00489840|Drug|Anecortave Acetate Sterile suspension 15 mg|anecortave acetate sterile suspension 15 mg., juxtascleral injection, every 6 months. for 24 months
16321334|NCT00489840|Drug|Anecortave Acetate|anecortave acetate suspension 15 mg. juxtascleral injection every 6 months for 24 months.
16321335|NCT00489827|Drug|Intravenous infusion of saline|Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
16321336|NCT00489827|Other|Intravenous glutamate infusion|Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
16321337|NCT00489814|Behavioral|Questionnaire|Questionnaires administered within 3 weeks before the beginning of the radiation treatment course, twice during radiation therapy, and upon completion of radiation therapy.
16321338|NCT00489801|Other|Exercise|Exercise intervention and lifestyle counseling at centre or exercise intervention at home
16321347|NCT00489710|Procedure|diagnostic procedure|
16321348|NCT00489710|Procedure|enzyme inhibitor therapy|
16321349|NCT00489710|Procedure|flow cytometry|
16321350|NCT00489710|Procedure|laboratory biomarker analysis|
16321351|NCT00489710|Procedure|non-specific immune-modulator therapy|
16321352|NCT00489697|Device|real-time contrast-enhanced ultrasound imaging (CEUS)|Real time contrast enhanced sonography was performed using an ultrasound dedicated system after bolus injection of 1.2 and 2x2.4 ml Sonovue ® (Bracco, Milan, Italy)
16321353|NCT00489658|Drug|Eflornithine plus Nifurtimox combination therapy|
16321354|NCT00489645|Drug|placebo|placebo SC during euglycemia
16321355|NCT00489645|Drug|pramlintide|pramlintide SC during eglycemia
16321356|NCT00489645|Drug|placebo|placebo during hyperglycemia
16321357|NCT00489645|Drug|pramlintide|pramlintide SC during hyperglycemia
16321358|NCT00489632|Behavioral|Questionnaire|Questionnaires administered to pediatric patients and their parent(s) or caregiver(s).
16321359|NCT00489606|Drug|SK3530|
16321360|NCT00489593|Drug|Olanzapine|2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.
16321361|NCT00489580|Device|SaeboFlex Dynamic Hand Orthosis|
16321362|NCT00489580|Procedure|Saebo F.T.M. Arm Training Program|
16321363|NCT00489567|Procedure|Blood sample collection|
16321364|NCT00489554|Biological|Synflorix|Intramuscular injection, 3 doses.
16321365|NCT00489554|Biological|Infanrix hexa|Intramuscular injection, 3 doses.
16321366|NCT00489554|Biological|Rotarix|Oral, 2 doses.
16321367|NCT00489541|Device|Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation|TAXUS Element stent implantation
16321368|NCT00489528|Drug|Somatropin; Recombinant human growth hormone (r hGH)|
16321369|NCT00489502|Behavioral|Brief Counseling|
16321370|NCT00489502|Device|REE Assessment|
16321371|NCT00489489|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16321372|NCT00489489|Drug|Placebo (for Teriflunomide)|"Film-coated tablet
~Oral administration"
16321373|NCT00489489|Drug|Interferon-β|Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
16321374|NCT00489476|Drug|Staccato Loxapine|
16321375|NCT00489476|Drug|Staccato Placebo|Placebo aerosol inhalation (0mg)
16321376|NCT00489463|Device|intra-uterine device (TCu 380A)|
16321377|NCT00489450|Drug|SK3530|
16321378|NCT00489437|Device|ID-PaGIA Heparin/PF4 antibody test|All patients have a 4T's Score completed, a same-day PaGIA performed and a Serotonin Release Assay performed.
16321379|NCT00489437|Procedure|Clinical Prediction Score-HIT Score Card|"clinical prediction rule
~rapid immunoassay"
16321380|NCT00489424|Drug|Placebo|
16321381|NCT00489424|Drug|Acetaminophen|
16321382|NCT00489424|Drug|Fluvastatin|
16321383|NCT00489411|Drug|duloxetine hydrochloride|Given orally
16321384|NCT00489411|Other|placebo|Given orally
16321385|NCT00489398|Drug|epinastine HCL and olopatadine HCL|
16321386|NCT00489385|Drug|Albinterferon|
16321387|NCT00489385|Drug|Ribavirin|
16321388|NCT00489385|Drug|Albuferon|
16321389|NCT00489372|Drug|Se-methyl-seleno-L-cysteine|Given orally
16321390|NCT00489372|Other|placebo|Given orally
16321391|NCT00489372|Other|pharmacological study|Correlative studies
16321392|NCT00489372|Other|laboratory biomarker analysis|Correlative studies
16321393|NCT00489359|Drug|Pemetrexed - Phase 1|500, 600, 700, 800, or 900 milligrams per square meter (mg/m^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)
16321394|NCT00489359|Drug|Carboplatin - Phase 1|area under the concentration time curve (AUC) 5 or 6 mg/mL*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)
16321395|NCT00489359|Drug|Pemetrexed - Phase 2|Dose determined from Phase 1: 500 mg/m^2, administered IV, every 21 days x 6 cycles
16321396|NCT00489359|Drug|Carboplatin - Phase 2|Dose determined from Phase 1: AUC 6 mg/mL*min, administered IV, every 21 days x 6 cycles
16321397|NCT00489346|Drug|MK0476, montelukast sodium / Duration of Treatment: 1 Year|
16321398|NCT00489346|Drug|Comparator : fluticasone propionate / Duration of Treatment: 1 Year|
16321399|NCT00489333|Drug|ProAlgaZyme|
16321400|NCT00489320|Device|Cypher Stent|
16321401|NCT00489307|Drug|Dexamethasone|4 mg PO (by mouth) twice daily x 14 days
16321402|NCT00489307|Drug|Placebo|Placebo PO twice daily x 14 days
16321403|NCT00489294|Drug|Syntropin|
16321404|NCT00489281|Drug|Cyclophosphamide|Cyclophosphamide (Cy) 14.5 mg/kg/day intravenously (IV) on Days -6 and -5 and 50 mg/kg/day IV on Days +3 and +4.
16321405|NCT00489281|Drug|Fludarabine|Fludarabine 30 mg/m^2/day IV on Days -6, -5, -4, -3, and -2.
16321406|NCT00489281|Drug|Mycophenolate mofetil|Mycophenolate mofetil 15 mg/kg by mouth (PO) three times a day from Day +5 to Day +35.
16321407|NCT00489281|Drug|Sirolimus|The first dose of Sirolimus is 6 mg PO on Day +5. Further dosing is adjusted according to drug levels. Sirolimus is continued through Day +365.
16321408|NCT00489281|Procedure|Allogeneic bone marrow transplant|An allogeneic bone marrow transplant is a procedure that involves taking bone marrow from a donor and giving it to a recipient.
16321409|NCT00489281|Radiation|Total body irradiation - 200|200 centigray (cGy) in one fraction on Day -1.
16321410|NCT00489281|Drug|Levetiracetam|Given at 500 mg PO twice daily from Day -6 to Day +365.
16321411|NCT00489281|Biological|Anti-thymocyte globulin|Test dose of 0.5 mg/kg IV given on Day -9, then 2 mg/kg/day IV on Day -8 and -7.
16321412|NCT00489281|Radiation|Total body irradiation - 400|400 centigray (cGy) in one fraction on Day -1.
16321413|NCT00489268|Device|HALO Ablation System|"Phase I: 1-2 ablation visits; Phase II 1 to 12 months: 1-2 ablation visits; Phase II 12 to 30 months: 1-3 ablation visits Phase II 55-60 months: 0-1 ablation visit
~******Phase I was a dosimetry study and Phase II used the preferred dose. The same intervention was used for each dose."
16321414|NCT00489255|Drug|Tigan®|Oral capsule, 300mg three times daily
16321415|NCT00489255|Drug|Placebo|Oral capsule, three times daily
16321416|NCT00489242|Procedure|Procedure / Percutaneous angioplasty|
16321417|NCT00489229|Drug|Rosiglitazone|
16321418|NCT00489229|Drug|Ramipril|
16321419|NCT00489216|Biological|efalizumab|"Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at
~1mg/kg"
16321420|NCT00489203|Drug|beclomethasone dipropionate|Given orally
16321421|NCT00489203|Drug|placebo|Given orally
16321422|NCT00489203|Drug|tacrolimus|Given after transplant
16321423|NCT00489203|Drug|methotrexate|Given after transplant
16321424|NCT00489203|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo stem cell transplant
16321425|NCT00489190|Drug|Insulin Glulisine|
16321426|NCT00489177|Device|A|QuickOpt intra-cardiac electrogram optimization
16321427|NCT00489177|Device|B|Single optimization in initial month post-implant
16321428|NCT00489164|Device|Sirolimus-Eluting BX Velocity Balloon-Expandable Stent|
16321429|NCT00489151|Drug|adefovir dipivoxil|
16321430|NCT00489151|Drug|lamivudine|
16321431|NCT00489138|Drug|Ertapenem|1g a day by drip of 30 min
16321432|NCT00489125|Other|physiologic testing|physical testing of range of motion, grip strength etc.
16321433|NCT00489112|Drug|Alfuzocine XL 10 mg once a day|
16321434|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot A|
16321435|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot B|
16321436|NCT00489099|Biological|V232 Modified Process Hepatitis B Vaccine: Lot C|
16321437|NCT00489099|Biological|V232 Current Process Hepatitis B Vaccine|
16321438|NCT00489086|Drug|tazarotene|Tazarotene is a member of the acetylenic class of retinoids.
16321439|NCT00489073|Drug|duloxetine|
16321440|NCT00489073|Drug|placebo|
16321441|NCT00489060|Procedure|Cryoablation and External Beam Radiation|
16321442|NCT00489034|Behavioral|Quantitative Interview|Index participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI.
16321443|NCT00489034|Behavioral|Ethnographic Interview|Qualitative interviews will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of 18 months. Interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and guide their progression.
16321444|NCT00489034|Behavioral|Gender Interview|Qualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey.
16321445|NCT00489021|Procedure|sub-acute hospitalization|
16321446|NCT00489008|Procedure|Stereotactic Body Radiation Therapy (SBRT)|"Cohorts 1 & 2: 50 gray (GY) with 12.5 GY per Fraction for 4 treatments
~Cohort 3: 40 GY with 10 GY per Fraction for 4 treatments"
16321447|NCT00488995|Drug|CP-675,206|
16321448|NCT00488982|Drug|Docetaxel|Docetaxel 75mg/m2 every 21 days
16321449|NCT00488982|Drug|Docetaxel and GM-CSF|Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28
16321450|NCT00488969|Drug|Modified-release morphine|During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first. During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication. During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.
16321451|NCT00488969|Drug|Placebo|
16321452|NCT00488943|Device|AAA Endovascular Bifurcated Stent-Graft|Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.
16321453|NCT00488930|Other|Observational|data collection ONLY
16321454|NCT00488904|Dietary Supplement|supportan|2 sip feed pr. day
16321455|NCT00488904|Dietary Supplement|supportan placebo|2 sip feed pr. day
16321456|NCT00488891|Drug|Paliperidone ER|Route = oral. Paliperidone ER will be prescribed to the patients at the investigator's discretion. Patient receive their medication according to usual care in their treatment setting ie, no study drug is provided
16321457|NCT00488891|Drug|Atypical antipsychotics (AAP)|Route = oral. AAP including quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion
16321458|NCT00488878|Procedure|Biospecimen Collection|Patients' residual tissue samples are collected
16321459|NCT00488878|Other|Electronic Health Record Review|Medical records are reviewed
16321460|NCT00488865|Device|Intravascular Filter Device|Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.
16321461|NCT00488839|Drug|IPX056 20 mg|IPX056 Extended Release capsule containing 20 mg baclofen
16321462|NCT00488839|Drug|IPX056 40 mg|IPX056 Extended Release capsule containing 40 mg baclofen
16321463|NCT00488839|Drug|Encapsulated Baclofen 20 mg|Baclofen 20mg tablet was encapsulated for blinding.
16321464|NCT00488839|Drug|Placebo Baclofen Tablet|Placebo capsule encapsulated placebo Baclofen tablet
16321465|NCT00488839|Drug|IPX056 10 mg|IPX056 Extended Release capsule containing 10 mg baclofen
16321466|NCT00488839|Drug|IPX056 30 mg|IPX056 Extended Release capsule containing 30 mg baclofen
16321467|NCT00488839|Drug|IPX056 35 mg|IPX056 Extended Release capsule containing 35 mg baclofen
16321468|NCT00488839|Drug|Placebo IPX056 20 mg|Placebo capsule for IPX056 20 mg
16321469|NCT00488839|Drug|Placebo IPX056 40 mg|Placebo capsule for IPX056 40 mg
16321470|NCT00488826|Biological|7-valent pneumococcal conjugate vaccine|
16321471|NCT00488826|Biological|Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)|
16321472|NCT00488813|Drug|Third generation cephalosporins|
16321473|NCT00488800|Biological|pneumococcal conjugate vaccine|
16321474|NCT00488787|Drug|intranasal ketamine|low dose
16321475|NCT00488787|Drug|intranasal ketamine|medium dose
16321476|NCT00488787|Drug|intranasal ketamine|high dose
16321477|NCT00488787|Drug|placebo|placebo
16321478|NCT00488774|Other|Placebo|Matching placebo for golimumab, intravenous infusion administered at Week 0
16321479|NCT00488774|Drug|Golimumab 1 mg per kg|Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
16321480|NCT00488774|Drug|Golimumab 2 mg per kg|Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
16321481|NCT00488774|Drug|Golimumab 4 mg per kg|Golimumab 4 mg per kg intravenous (IV) infusion at Week 0
16321482|NCT00488761|Drug|Tigecycline|
16321483|NCT00488748|Device|Thymatron|Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
16321484|NCT00488748|Device|Magstim Theta|100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
16321485|NCT00488735|Behavioral|Cognitive-behavioral rehabilitation|
16321486|NCT00488735|Behavioral|Traditional primary care|
16321487|NCT00488722|Drug|Zoladex|
16321488|NCT00488709|Drug|Topotecan|
16321489|NCT00488709|Drug|Fludarabine|
16321490|NCT00488709|Drug|Cytarabine|
16321491|NCT00488696|Device|Endovascular Bifurcated Stent-Graft|Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.
16321492|NCT00488683|Biological|MenACWY-CRM|One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.
16321493|NCT00488683|Biological|DTaP-Hib-IPV|IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.
16321494|NCT00488683|Biological|PCV|IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.
16321495|NCT00488683|Biological|MMR|IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.
16321496|NCT00488683|Biological|Hib|IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.
16321497|NCT00488670|Drug|Escitalopram|See Detailed Description.
16321498|NCT00488657|Device|SpeechEasy Model ITC|The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.
16321499|NCT00488644|Drug|Levothyroxine|75 mcg by mouth (PO) Daily for 8 Weeks
16321500|NCT00488644|Drug|Liothyronine|15 mcg PO Daily for 8 Weeks
16321501|NCT00488631|Biological|Placebo|Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
16321502|NCT00488631|Biological|Golimumab 50 mg|Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
16321503|NCT00488631|Biological|Golimumab 100 mg|Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
16321504|NCT00488631|Biological|Golimumab 200 mg|Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
16321505|NCT00488618|Drug|Cariprazine (RGH-188)|Cariprazine 3 mg - 12 mg oral administration, once per day.
16321506|NCT00488618|Drug|Placebo|Dose-matched placebo oral administration, once per day.
16321507|NCT00488605|Drug|Prednisone, Vinblastin, 6-mercaptopuroine|Initial Therapy:Prednisone- by mouth 3 times/day daily as a 4-week course, then gradually decreased over 2 more weeks. Vinblastine-IV (into a vein)1 day/week for 6 weeks. Patients w/o evidence of active disease at this time will proceed to continuation therapy. If disease is improved or unchanged, pts. will receive additional therapy with: Prednisone- 3 divided doses by mouth for 3 days every week, from week 7-12. Vinblastine- IV 1day/week for 6 more weeks. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP:by mouth daily until the end of month 12. Prednisone in 3 doses daily day 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12.
16321508|NCT00488605|Drug|Leucovorin, Methotrexate, Vinblastine, Prednisone|Initial Therapy:Prednisone-by mouth 3x/day daily as a 4-week course then gradually decreased over 2 more weeks. Vinblastine- IV 1 day/week for 6 weeks. Methotrexate-a 24 hour IV infusion day 1 of weeks 1, 3, and 5, followed by leucovorin.The drug will be given by mouth. Pts w/o evidence of active disease at this time will proceed to continuation therapy. Pts whose disease is improved or unchanged will receive additional therapy w/:Prednisone- 3 divided doses, days 1-3 weekly from week 7-12. Vinblastine IV 1day/week for 6 more weeks. Methotrexate-a 24 hour IV infusion day 1 of week 7, 9, and 11, followed by leucovorin. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP by mouth daily until the end of month 12. Prednisone- 3 doses daily days 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12. Methotrexate by mouth once weekly until the end of month 12.
16321543|NCT00488267|Drug|Ketoprofen matrix/placebo CHADD Patch|Transdermal knee applied to the knee for 12 hours daily.
16321544|NCT00488241|Device|Zarzenda|Topically applied daily for 2 weeks
16321545|NCT00488228|Behavioral|self-regulation|The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.
16321509|NCT00488592|Biological|WT1:126-134|"Subjects were given 6 doses of PR1:169-177 in Montanide adjuvant and 6 doses of WT1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals."
16321510|NCT00488592|Biological|PR1:169-177 Peptide|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
16321511|NCT00488592|Drug|GM-CSF (Sargramostim)|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
16321512|NCT00488592|Biological|Montanide adjuvant|Subjects were given 6 doses of PR1:169-177 in montanide adjuvant and 6 doses of WT-1:126-134 in Montanide adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injection were rotated every 2 weeks. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
16321513|NCT00488579|Drug|Two policies of iron prophylaxis|60mg ferrous sulphate daily (+folic acid); Screening and therapy: Hb measurement on each visit, Hb>9g/dl only folic acid, Hb<9g/dl 60-120 of ferrous sulphate daily (+folic acid).
16321514|NCT00488566|Drug|GSK drug|GSK drug
16321515|NCT00488566|Other|Placebo|Placebo
16321516|NCT00488566|Other|Lamictal|Positive control
16321517|NCT00488553|Behavioral|Questionnaire|Questions about cancer risk factors, medical history, and family history of cancer.
16321518|NCT00488540|Drug|Paracetamol|Suppository
16321519|NCT00488540|Drug|Placebos|Suppository
16321520|NCT00488527|Drug|Insulin glargine|Patients will begin with a fixed, subcutaneous dose of insulin glargine, (10 U), in its commercial presentation, which will be adjusted week by week, according to the values of the glycemia when fasting (FBG), adding 2, 4, 6 or 8 units of insulin glargine over the following twelve weeks, during which the therapeutic objective should be attained, namely the glucose goal during fasting of 100 mg/dl (<6.0 mmol/L), and the active treatment is to be continued for three more months.
16321521|NCT00488514|Drug|Combination Tablet of Treximet (sumatriptan/naproxen sodium)|Combination Tablet of Treximet(sumatriptan/naproxen sodium)
16321522|NCT00488488|Drug|tigecycline|The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16321523|NCT00488475|Drug|etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16321524|NCT00488462|Device|non-pneumatic anti-shock garment|In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.
16321525|NCT00488449|Drug|GSK256073A tablets|
16321526|NCT00488436|Drug|Antithymocyte globulin|
16321527|NCT00488436|Drug|Cyclosporine|
16321528|NCT00488423|Procedure|Mixed Meal Tolerance test, Hyperglycemic clamp|Subjects undergo a standard mixed meal tolerance test & hyperglycemic clamp to assess insulin secretion & sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp & mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting & specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass & gastric banding.
16321529|NCT00488410|Device|Doppler echocardiography|
16321530|NCT00488397|Other|In-vitro testing|This is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study.
16321531|NCT00488384|Drug|Chemopreventive application (Acitretin)|Chemopreventive application (Acitretin)
16321532|NCT00488371|Biological|Pneumococcal Conjugated Vaccine (Prevnar®)|
16321533|NCT00488345|Drug|Tygacil|
16321534|NCT00488332|Procedure|Optical Coherence Tomography|Before radiation treatment and once a week thereafter.
16321535|NCT00488332|Procedure|Fluorescence Spectroscopy|Before radiation treatment and once a week thereafter.
16321536|NCT00488332|Behavioral|Pain Scale Questionnaire|Administered before the examination, OCT, and FS and immediately afterward.
16321537|NCT00488319|Drug|Paliperidone ER|1.5 to 12 mg tablet once daily for 6 months
16321538|NCT00488306|Drug|tigecycline|
16321539|NCT00488293|Procedure|Store and forward teledermatology|Standard electronic consult, standardized history, and image set
16321540|NCT00488280|Behavioral|Locomotor Training|Task-specific practice of walking with assistance from trainers using body weight support and treadmill followed by training over ground, 5x/week, approximately 1.5 hours/day
16321541|NCT00488267|Drug|ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)|Transdermal patch applied to the knee for 12 hours daily.
16321542|NCT00488267|Drug|Placebo Matrix/CHADD Patch|Transdermal patch applied to the knee for 12 hours daily.
16321546|NCT00488215|Drug|prucalopride|The dose will be consecutively escalated in 2 mg steps per day, starting from 2 mg up to 20 mg once daily or until severe drug-related adverse events occur (= individual maximum tolerable dose, on decision of the subject and/or investigator).
16321547|NCT00488215|Other|Placebo|During the placebo session, the number of placebo tablets will be consecutively escalated in an identical way as described for prucalopride. This means 1 tablet more every day, up to 10 tablets.
16321548|NCT00488189|Drug|Tazocin (pipercillin/tazobactam)|over 50% third generation cephalosporin should be replaced by Pip/Taz
16321549|NCT00488176|Drug|montelukast|montelukast sodium
16321550|NCT00488176|Drug|cetirizine|cetirizine
16321551|NCT00488176|Drug|montelukast and cetirizine|montelukast and cetirizine
16321552|NCT00488176|Drug|placebo|placebo
16321553|NCT00488163|Drug|Atomoxetine|Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
16321554|NCT00488137|Drug|Prucalopride|2 mg o.d.
16321555|NCT00488137|Other|Placebo|o.d.
16321556|NCT00488137|Drug|Prucalopride|4 mg o.d.
16321557|NCT00488124|Drug|somatropin (Genotropin® treatment)|0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)
16321558|NCT00488111|Other|Ringer's Lactate|Ringer's Lactate was used 15min before operation
16321559|NCT00488111|Other|6% Starch|6% Starch was used 15min before operation
16321560|NCT00488098|Drug|GSK372475|
16321561|NCT00488072|Drug|Mirtazapine|15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.
16321562|NCT00488072|Drug|Placebo|One placebo tablet by mouth daily.
16321563|NCT00488059|Drug|enfuvirtide [Fuzeon]|90 mg SC twice daily
16321564|NCT00488059|Drug|Optimized background ARV|As prescribed
16321565|NCT00488059|Drug|Integrase inhibitor|As prescribed
16321566|NCT00488059|Drug|enfuvirtide [Fuzeon]|180 mg SC once daily
16321567|NCT00488046|Biological|H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)|Intranasal vaccine
16321568|NCT00488033|Procedure|CT Angiography|If results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids.
16321569|NCT00488020|Procedure|stem cells transplant|
16321570|NCT00488007|Device|Hearing aids used : PHONAK Savia and Valeo|5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)
16321571|NCT00487994|Drug|Lapaquistat acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin placebo-matching capsules, orally, once daily for up to 96 weeks.
16321572|NCT00487994|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
16321573|NCT00487994|Drug|Atorvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
16321574|NCT00487981|Device|Precision Spinal Cord Stimulation|Stimulation on throughout the study once device is implanted
16321575|NCT00487968|Drug|eltrombopag|
16321576|NCT00487955|Procedure|Resting Energy Expenditure examination|
16321577|NCT00487942|Drug|armodafinil|50 mg/day armodafinil
16321578|NCT00487942|Drug|armodafinil|100 mg/day armodafinil
16321579|NCT00487942|Drug|armodafinil|200 mg/day armodafinil
16321580|NCT00487942|Drug|placebo|placebo
16321581|NCT00487929|Device|nasal CPAP|Nocturnal
16321582|NCT00487929|Device|Sham CPAP|Nocturnal
16321583|NCT00487916|Drug|AMA1-C1/ISA 720|
16321584|NCT00487903|Drug|PB127 for Injectable Suspension|0.062 mg/kg continuous IV (100-250 mL/hr) during echocardiogram, single dose, infusion not to exceed 60 minutes.
16321585|NCT00487877|Device|SenseWear Pro3 Armband|
16321586|NCT00487877|Device|i-button DS2191 H|
16321587|NCT00487851|Procedure|surgery|hepaticojejunostomy and gastroenterostomy
16321588|NCT00487851|Procedure|endoscopic strategy|Stent insertion
16321589|NCT00487825|Drug|Canakinumab (investigational)|Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
16321590|NCT00487825|Drug|Placebo|Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
16321591|NCT00487825|Drug|Methotrexate (MTX)|Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
16321592|NCT00487812|Procedure|Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging|All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)
16321593|NCT00487799|Drug|Ularitide|
16321594|NCT00487786|Drug|OGX-427|OGX-427 injection at 200mg, 400mg, 600mg, 800mg or 1000mg once a week until withdrawn
16321595|NCT00487786|Drug|Docetaxel|injection - 75 mg/M2 IV on Day 1 every 21 days for cohorts 6 & 7 only, together with appropriate dose of OGX-427 until withdrawn from study
16321596|NCT00487773|Drug|budesonide|budesonide
16321597|NCT00487773|Drug|D3 vitamin|D3 vitamin
16321598|NCT00487773|Drug|montelukast sodium|montelukast sodium
16321599|NCT00487773|Drug|salbutamol|salbutamol
16321600|NCT00487747|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
16321601|NCT00487734|Radiation|Testosterone gel|testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
16321602|NCT00487734|Drug|Placebo for testosterone gel|Placebo gel, 2.5g for each gel packet
16321603|NCT00487721|Drug|Silibin-Phytosome|Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.
16321604|NCT00487708|Drug|canakinumab|
16321707|NCT00486850|Other|Extubation to Nasal IPPV|Comparison of extubation to NIPPV versus NCPAP
16321757|NCT00486525|Procedure|Yoga Therapy|Patients will undergo yoga therapy
16321605|NCT00487695|Device|confocal laser endomicroscopy (CLE)|Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.
16321606|NCT00487695|Device|standard endoscopy (EGD)|Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
16321607|NCT00487682|Drug|ASP2151|oral
16321608|NCT00487682|Drug|Valacyclovir hydrochloride|oral
16321609|NCT00487669|Drug|paclitaxel poliglumex, pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued
16321610|NCT00487656|Drug|ART-123|6mg/ml ampule solution for injection @ .01mg/kg
16321611|NCT00487656|Drug|placebo|6 mg/ml ampule solution for injection at .01mg/kg
16321612|NCT00487643|Procedure|Tear Collection|The tear sample will be collected from the left eye of each subject. Subjects wearing contact lenses will be instructed to remove their lenses and wait at least 5 minutes before proceeding with the tear collection procedure. The patient will then be instructed to sit with eyes gently closed for two minutes after instilling one (1) drop of 0.5% proparacaine on the cornea and conjunctiva. Tear collection was accomplished by using a polyester fiber rod wick. This wick will be placed in contact with the tear fluid at the lower cul-de-sac for a minimum time to obtain fluid without irritating the subject's eye approx. for 3 to 5 minutes.
16321613|NCT00487630|Drug|recombinant alpha-galactosidase A|
16321614|NCT00487617|Procedure|Fruit juice or placebo absorption|absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
16321615|NCT00487591|Drug|Omacor (omega-3-acid ethyl esters)plus simvastatin|Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)
16321616|NCT00487591|Drug|simvastatin plus placebo|simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo
16321617|NCT00487578|Drug|naratriptan HCl|naratriptan 2.5mg tablet bid x 30 days OR matching placebo
16321618|NCT00487565|Device|Total knee arthroplasty|Total knee arthroplasty using a posterior stabilized implant
16321619|NCT00487552|Device|Cook Magnetic Anastomosis Device (MAD) with Stent|Gastro-jejunal anastomosis
16321620|NCT00487539|Biological|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
16321621|NCT00487539|Biological|Golimumab 100 mg|Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group.
16321622|NCT00487539|Biological|Golimumab 200 mg|Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group.
16321623|NCT00487539|Biological|Golimumab 400 mg|Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group.
16321624|NCT00487539|Biological|Golimumab 50 mg|Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group.
16321625|NCT00487526|Procedure|duodenal jejunal bypass|
16321626|NCT00487513|Procedure|Procurement of Follicular B Cell Lymphoma Cells|Participants will undergo the following procedure(s) that are appropriate for collecting their tissue: Blood collection, lymph node biopsy, drainage of an effusion, or bone marrow biopsy
16321627|NCT00487500|Device|Electroconvulsive Therapy (ECT)|Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
16321628|NCT00487474|Device|DL6049 (injectable poly-L-lactic acid)|Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
16321629|NCT00487461|Drug|Simvastatin 40 mg|Comparing two doses of Simvastatin to placebo
16321630|NCT00487461|Drug|Placebo|Placebo tablet
16321631|NCT00487461|Drug|Simvastatin 80 mg|Comparing two doses of Simvastatin to placebo
16321632|NCT00487448|Drug|Fludarabine|
16321633|NCT00487448|Drug|Cytarabine|
16321634|NCT00487448|Drug|G-CSF|
16321635|NCT00487448|Drug|Idarubicin|
16321636|NCT00487448|Procedure|Peripheral blood stem cell transplantation|
16321637|NCT00487448|Procedure|Bone marrow transplantation|
16321638|NCT00487435|Drug|Tapentadol (CG5503) Extended Release (ER)|100, 150, 200, 250 mg oral tablet twice daily for 52 weeks
16321639|NCT00487422|Drug|prucalopride|2 mg o.d.
16321640|NCT00487422|Drug|Prucalopride|4 mg o.d.
16321641|NCT00487422|Other|Placebo|o.d.
16321642|NCT00487409|Procedure|Bipolar electrosurgical generator and instruments|laparoscopic colectomy using the Ligasure device
16321643|NCT00487409|Procedure|Disposable stapling instruments|laparoscopic colectomy using clips, cautery and stapler
16321644|NCT00487396|Device|Capsule Endoscopy|Pillcam Platform with RAPID5 software and supporting SB2 capsules
16321645|NCT00487370|Procedure|Implantation of gold beads around a knee through needles|
16321646|NCT00487370|Procedure|Sham implantation: Insertion of needles around a knee|
16321647|NCT00487357|Behavioral|Supplemental Survey|Questionnaire give during home visit to collect behavioral, risk factors and other smoking status data on MATCh parents/guardians.
16321648|NCT00487344|Procedure|Non-Personalized Meal Planning|
16321649|NCT00487344|Procedure|Personalized Meal Planning and Dietetic Consultation|
16321650|NCT00487331|Other|Acupuncture|Acupuncture sessions 1-3 times per week.
16321651|NCT00487331|Behavioral|Survey|2 pain questionnaires + satisfaction survey completed at beginning and end of treatment
16321652|NCT00487318|Drug|standard of care|peginterferon/RBV
16321653|NCT00487318|Drug|fluvastatin|Add fluvastatin at 20-40 mg/day to standard of care
16321708|NCT00486837|Drug|Alpha1-Proteinase Inhibitor (Human)|25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.
16321830|NCT00485979|Drug|larotaxel (XRP9881)|intravenous administration
16321654|NCT00487305|Biological|Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells|Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines.
16321655|NCT00487292|Behavioral|naps and pulses of bright light|
16321656|NCT00487279|Device|Defibrillator|ICD(Implantable Cardioverter Defibrillator)
16321657|NCT00487279|Other|Control|No Intervention
16321658|NCT00487266|Other|Acupuncture|Acupuncture of low back and legs.
16321659|NCT00487253|Drug|Miltefosine|Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
16321660|NCT00487253|Drug|Meglumine antimoniate|Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
16321661|NCT00487240|Drug|Insulin Lispro Protamine Suspension|Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
16321662|NCT00487240|Drug|Insulin Levemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
16321663|NCT00487227|Drug|caffeine|
16321664|NCT00487227|Drug|Placebo|
16321665|NCT00487201|Procedure|endoscopic balloon dilatation|
16321666|NCT00487201|Procedure|plastic stent placement|
16321667|NCT00487188|Drug|Enfuvirtide|90 mg subcutaneous injection twice a day
16321668|NCT00487188|Drug|Highly active antiretroviral treatment (HAART)|An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.
16321669|NCT00487175|Drug|Tramadol|to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
16321670|NCT00487162|Procedure|intensive glycemic control|intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
16321671|NCT00487162|Drug|conventional glycemic control|Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
16321672|NCT00487136|Drug|Warfarin|Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
16321673|NCT00487136|Drug|warfarin plus ABT-335 plus rosuvastatin 5 mg|Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
16321674|NCT00487136|Drug|warfarin plus ABT-335 plus rosuvastatin 20 mg|Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
16321675|NCT00487123|Drug|Valsartan+/- Hydrochlorothiazide|
16321676|NCT00487110|Drug|Tropisetron|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol
16321677|NCT00487110|Drug|paracetamol|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol
16321678|NCT00487097|Dietary Supplement|Eicosapentanoic acid, docosahexaenoic acid|Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
16321679|NCT00487084|Drug|Morphine-CP-saline (MCS)|3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision
16321680|NCT00487084|Drug|saline-2CP-morphine (SCM)|6ml of saline will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 3mg of preservative free morphine will be administered at skin incision
16321681|NCT00487084|Drug|saline-lidocaine-morphine (SLM)|3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 2% lidocaine with epinephrine 1:200,000 will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision
16321682|NCT00487071|Device|Anal fistula plug|
16321683|NCT00487058|Drug|Gimatecan|
16321684|NCT00487045|Device|Hem-Avert Perianal Stabilizer|Hem-Avert Perianal Stabilizer, TNP-01L, single-use, disposable, sterile, individually packaged instrument
16321685|NCT00487032|Drug|Oxymetazoline 0.05% w/v|2 squirts in each nostril thrice daily
16321686|NCT00487032|Drug|Fluticasone propionate 50 micrograms per actuation|2 Squirts in each nostril twice daily
16321687|NCT00487032|Drug|Prazosin hydrochloride|Prazosin 1mg one dose only
16321688|NCT00487032|Drug|Placebo to Prazosin|Placebo 1 tablet one dose only
16321689|NCT00487006|Other|Serum Lab testing|Serum Lab testing
16321690|NCT00486993|Behavioral|Dietary and nutritional modification|
16321691|NCT00486993|Behavioral|Stop smoking|
16321692|NCT00486993|Behavioral|Regular physical activities|
16321693|NCT00486993|Behavioral|Weight reduction to normal ranges|
16321694|NCT00486993|Behavioral|Regular intake of polyphenols, esp. from Ilex paraguayensis|
16321695|NCT00486980|Drug|Peramivir 150mg|
16321696|NCT00486980|Drug|Peramivir 300mg|
16321697|NCT00486954|Drug|Lapatinib|6 pills at 250 mg each once daily
16321698|NCT00486954|Drug|Paclitaxel|Infusion at 80 mg/m2 weekly
16321699|NCT00486941|Behavioral|Exercise and diet - based on DPS and DPP|
16321700|NCT00486915|Procedure|Left Atrial Appendage Ligation|
16321701|NCT00486902|Drug|Ketamine|Ketamine 10 mg diluted to 20 mL delivered over 10 minutes via an infusion pump set at 2ml/minute
16321702|NCT00486902|Drug|Placebo|Saline 20 mL IV infusion delivered over 10 minutes via an infusion pump set at 2ml/minute
16321703|NCT00486889|Biological|alglucosidase alfa|Intravenous (IV) infusion: 20mg/kg every 2 weeks
16321704|NCT00486876|Drug|Dextofisopam|capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
16321705|NCT00486863|Drug|Praziquantel|60 mg/kg administered orally given in split dose (30/mg/kg each) separated by 3 hours; over-encapsulated in gelatin capsules. Two capsule sizes will be made which will be differentiated by color; these will contain 300 mg or 150 mg to allow for best dosing by weight.
16321706|NCT00486863|Other|Placebo|Made with the same color coded gelatin capsules with the inert compound dextrose.
16321831|NCT00485979|Drug|docetaxel|intravenous administration
16321709|NCT00486824|Drug|Indomethacin|One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
16321710|NCT00486824|Drug|Nifedipine|Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
16321711|NCT00486811|Drug|Tapentadol ER (100 to 250 mg twice daily)|50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
16321712|NCT00486811|Drug|Matching Placebo (twice daily)|Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
16321713|NCT00486811|Drug|Oxycodone CR (20 to 50 mg twice daily)|10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
16321714|NCT00486798|Drug|Quetiapine|
16321715|NCT00486798|Procedure|Rating Scales|
16321716|NCT00486798|Procedure|Self Assessment Form|
16321717|NCT00486798|Procedure|Blood and urine samples|
16321718|NCT00486798|Procedure|Sleeping pattern|
16321719|NCT00486785|Drug|Alfuzosin|Alfuzosin 10mg Once Daily for 24 weeks
16321720|NCT00486772|Drug|Sevelamer (Renagel), calcium acetate (Phos-ex)|
16321721|NCT00486759|Drug|Bevacizumab|Bevacizumab was administered at a dose of 15 mg/kg IV on Day 1 of each 21-day cycle for 8 cycles or at a dose 10 mg/kg IV on Day 1 of each 14-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
16321722|NCT00486759|Drug|Rituximab|Rituximab was administered at a dose of 375 mg/m^2 IV on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
16321723|NCT00486759|Drug|CHOP|Cyclophosphamide was administered at a dose of 750 mg/m^2 IV on Day 1 of each cycle. Doxorubicin was administered at a dose of 50 mg/m^2 IV on Day 1 of each cycle. Vincristine was administered at a dose of 1.4 mg/m^2 IV (maximum of 2 mg) on Day 1 of each cycle. Prednisone was administered at a dose of 100 mg orally on Days 1-5 of each cycle. All 4 drugs were administered either every 21 days for 8 cycles or every 14 days for 6 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
16321724|NCT00486759|Drug|Placebo|Placebo to bevacizumab was administered on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.
16321725|NCT00486746|Behavioral|Lifestyle intervention (physical activity and dietary counseling)|One-year intervention
16321726|NCT00486746|Behavioral|General information on healthy lifestyle habits|A single session
16321727|NCT00486733|Device|DermaGold|The first four follow-up study assessment and data collection points will coincide with scheduled operative interventions on the wound guided by clinical situation and the treating physician's judgment (approximately every 3-4 days). Subsequent follow-up study assessment and data collection points will occur on study days 28 ± 3, 42 ± 3, 60 ± 3, and 90 ± 3.
16321728|NCT00486720|Drug|vorinostat|vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.
16321729|NCT00486720|Drug|vorinostat|vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.
16321730|NCT00486707|Behavioral|Questionnaire|A questionnaire will be completed.
16321731|NCT00486694|Drug|Sulfadoxine-pyrimethamine + artesunate|
16321732|NCT00486694|Drug|Chloroquine|
16321733|NCT00486681|Device|Accu Chek Inform and Cobas IT 1000|period II (warning activated)
16321734|NCT00486668|Drug|doxorubicin|60 mg/m2 IV every 21 days for cycles 1-4
16321735|NCT00486668|Drug|cyclophosphamide|600 mg/m2 IV every 21 days for cycles 1-4
16321736|NCT00486668|Drug|paclitaxel|80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
16321737|NCT00486668|Drug|trastuzumab|First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery
16321738|NCT00486668|Drug|lapatinib|Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.
16321739|NCT00486655|Procedure|NOTES-Assisted Cholecystectomy|
16321740|NCT00486642|Drug|Bicalutamide|Given PO
16321741|NCT00486642|Other|Laboratory Biomarker Analysis|Correlative studies
16321742|NCT00486642|Drug|Pazopanib Hydrochloride|Given PO
16321743|NCT00486642|Other|Pharmacological Study|Correlative studies
16321744|NCT00486629|Behavioral|Exercise and dietary education|Exercise and dietary education. Aerobic exercise or walk for 3-5 times/day for 30-45 min/time from 20 weeks to 36 weeks of pregnancy. Dietary education on nutrition for healthy pregnancy through weekly class during pregnancy.
16321745|NCT00486616|Device|electrical impedance tomography|
16321746|NCT00486616|Procedure|double-lumen tube placement|
16321747|NCT00486603|Drug|hydroxychloroquine|see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles
16321748|NCT00486603|Drug|temozolomide|TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)
16321749|NCT00486603|Other|pharmacological study|Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4
16321750|NCT00486603|Radiation|Radiation|Radiation during the first six weeks of treatment Monday-Friday
16321751|NCT00486590|Procedure|Prolact-Plus Human Milk Fortifier|
16321752|NCT00486577|Procedure|significant chronic primary auditory cortex stimulation during the first two weeks|significant chronic primary auditory cortex stimulation during the first two weeks of the follow up than wash out period followed by two weeks of non significant stimulation
16321753|NCT00486577|Procedure|non significant chronic primary auditory cortex stimulation during the first two weeks|non significant stimulation during the first two weeks of the follow up than wash out period followed by two weeks of significant chronic primary auditory cortex stimulation
16321754|NCT00486564|Drug|Nifurtimox|Escalating dose by cohort starting at 20mg/kg/day. PO drug taken TID.
16321755|NCT00486551|Behavioral|Anger control training|
16321756|NCT00486538|Drug|ABT-869|One oral dose daily.
16321758|NCT00486512|Drug|0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)|
16321759|NCT00486512|Drug|75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)|
16321760|NCT00486512|Drug|placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)|
16321761|NCT00486512|Drug|placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)|
16321762|NCT00486512|Procedure|Colonoscopy|
16321763|NCT00486499|Procedure|I-125 versus Pd-103 radioactive seed insertion|
16321764|NCT00486486|Drug|Drug: bimatoprost/timolol fixed combination AM|3-month chronic dosing in the morning
16321765|NCT00486486|Drug|Bimatoprost/timolol fixed combination dosed PM|Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
16321766|NCT00486473|Drug|Multihance|0.5 Molar at a single dose injection
16321767|NCT00486473|Drug|Magnevist|0.5M at a single dose injection
16321768|NCT00486460|Drug|Gemcitabine|
16321769|NCT00486460|Drug|Curcumin|
16321770|NCT00486460|Drug|Celebrex|
16321771|NCT00486447|Device|64 Channel VCT|cardiac CT angiography exam
16321772|NCT00486434|Drug|SMC021 Oral Calcitonin|0.8mg SMC021 (Oral Calcitoinin) twice daily
16321773|NCT00486434|Drug|SMC021 Placebo|Placebo orally, twice daily
16321774|NCT00486421|Biological|Rituximab|375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
16321775|NCT00486421|Drug|Prednisone|1mg/kg/d PO, taper to off by 8 weeks
16321776|NCT00486408|Biological|MRKAd5 HIV-1 gag/pol/nef|1.5x10^10 Ad vg
16321777|NCT00486395|Device|CPAP|"CPAP administered via Bubble method or Infant Flow Driver"
16321778|NCT00486395|Device|Mechanical ventilation|Volume guarantee strategy
16321779|NCT00486382|Biological|Leish-111f + MPL-SE Adjuvant|
16321780|NCT00486369|Drug|Oral salmon calcitonin|
16321781|NCT00486356|Drug|capecitabine|
16321782|NCT00486356|Drug|carboplatin|
16321783|NCT00486356|Drug|epirubicin hydrochloride|
16321784|NCT00486356|Genetic|microarray analysis|
16321785|NCT00486356|Genetic|polymorphism analysis|
16321786|NCT00486356|Other|pharmacological study|
16321787|NCT00486343|Drug|Zileuton CR|Zileuton CR tablets 2x600mg BID for 24 weeks
16321788|NCT00486343|Drug|Placebo|Placebo tablets 2x600mg BID for 24 weeks
16321789|NCT00486330|Drug|Buprenorphine, Tipranavir and ritonavir|After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days.
16321790|NCT00486317|Drug|Oral salmon calcitonin, salmon calcitonin nasal spray|
16321791|NCT00486304|Other|ADD|The ADD has a composition of 65% carbohydrate, 20% fat, and 15% protein. The diet will be completely depleted of vitamins A, E and beta-carotene; it will have 10 mg of vitamin C (6.5% of RDA) added per person per day
16321792|NCT00486304|Other|Placebo|Jevity 1.5 (1.5 cal/mL) will be used for the placebo patients in this study. This will simulate the standard of care for patients not on the ADD. Jevity 1.5 is an isotonic, fiber-fortified, high-nitrogen liquid formula providing complete, balanced nutrition for patients requiring short- or long-term tube feeding, given once per day
16321793|NCT00486291|Drug|VI-0521|phentermine 15mg/topiramate 100mg
16321794|NCT00486291|Drug|Placebo|matched placebo
16321795|NCT00486278|Drug|eptacog alfa (activated)|90 mcg/kg, injected i.v.
16321796|NCT00486278|Drug|vatreptacog alfa (activated)|5 mcg/kg, injected i.v.
16321797|NCT00486278|Drug|vatreptacog alfa (activated)|10 mcg/kg, injected i.v.
16321798|NCT00486278|Drug|vatreptacog alfa (activated)|20 mcg/kg, injected i.v.
16321799|NCT00486278|Drug|vatreptacog alfa (activated)|40 mcg/kg, injected i.v.
16321800|NCT00486278|Drug|vatreptacog alfa (activated)|80 mcg/kg, injected i.v.
16321801|NCT00486265|Drug|AZD4877|intravenous infusion administered on days 1, 2 and 3
16321802|NCT00486252|Other|Observational|This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.
16321803|NCT00486239|Behavioral|neuropsychological evaluation|
16321804|NCT00486226|Device|Vascular Reconstruction Device|CORDIS ENTERPRISE™ VRD
16321805|NCT00486213|Dietary Supplement|pyridoxine hydrochloride|Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
16321806|NCT00486213|Other|Placebo|
16321807|NCT00486200|Drug|ASP2151|Oral administration.
16321808|NCT00486200|Drug|valacyclovir|Oral administration of active comparator.
16321809|NCT00486200|Drug|Placebo|Oral administration of placebo.
16321810|NCT00486187|Drug|rosiglitazone|
16321811|NCT00486187|Drug|metformin or sulfonylurea|
16321812|NCT00486174|Drug|methylene blue|2.0 mg/kg of Methylene Blue administered every 6 hours (as required) for up to 48 hours.
16321813|NCT00486148|Other|Infant formula (with GOS)|Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
16321814|NCT00486135|Drug|XL147 (SAR245408)|Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
16321815|NCT00486135|Drug|XL147 (SAR245408)|Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths
16321816|NCT00486122|Drug|Atomoxetine Hydrochloride|
16321817|NCT00486122|Drug|Placebo|
16321818|NCT00486109|Device|I-Port(TM) Injection Port|
16321819|NCT00486083|Drug|Atomoxetine Hydrochloride|
16321820|NCT00486083|Drug|Methylphenidate Hydrochloride|
16321821|NCT00486044|Drug|Simvastatin|40 mg tablet each night for one month, then 80 mg for 8 months
16321822|NCT00486044|Drug|Placebo|Matching tablet each night for 9 months
16321823|NCT00486031|Drug|Balsalazide Disodium|
16321824|NCT00486018|Drug|Ranibizumab injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
16321825|NCT00486018|Drug|Ranibizumab injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
16321826|NCT00486018|Drug|Sham injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
16321827|NCT00486005|Drug|Olanzapine Hydrochloride|
16321828|NCT00486005|Drug|Nizatidine|
16321829|NCT00486005|Drug|Placebo|
16321832|NCT00485979|Drug|trastuzumab|intravenous administration
16321833|NCT00485966|Drug|CX-3543|360 mg/m2 daily x 5 q 21 days
16321834|NCT00485953|Drug|risedronate|risedronate 35 mg per week
16321835|NCT00485940|Drug|Prucalopride|2 mg o.d.
16321836|NCT00485940|Other|Placebo|Placebo o.d.
16321837|NCT00485940|Drug|Prucalopride|4 mg o.d.
16321838|NCT00485927|Behavioral|stress|
16321839|NCT00485914|Behavioral|On-site work evaluation|Researchers will measure the effects of worksite assessment through an on-site work evaluation by an occupational therapist on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through one-to-one contact and an individualized work plan. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
16321840|NCT00485914|Behavioral|Educational material|Researchers will measure the effects of worksite assessment through educational materials on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through educational materials to develop strategies to compensate. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
16321841|NCT00485901|Drug|Olanzapine Hydrochloride|
16321842|NCT00485901|Drug|Haloperidol|
16321843|NCT00485888|Drug|Cipralex|10-20mg; one per day
16321844|NCT00485888|Drug|Placebo|Matched to Cipralex
16321845|NCT00485875|Drug|Atomoxetine Hydrochloride|
16321846|NCT00485862|Drug|Atomoxetine Hydrochloride|
16321847|NCT00485862|Drug|Sertraline|
16321848|NCT00485862|Drug|Placebo|
16321849|NCT00485849|Drug|Atomoxetine Hydrochloride|
16321850|NCT00485836|Drug|Sham injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
16321851|NCT00485836|Drug|Ranibizumab injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
16321852|NCT00485836|Drug|Ranibizumab injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
16321853|NCT00485823|Drug|Olanzapine Hydrochloride|
16321854|NCT00485823|Procedure|Weight Management Program|
16321855|NCT00485810|Drug|Olanzapine Hydrochloride|
16321856|NCT00485797|Drug|Ritalin|The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design
16321857|NCT00485784|Other|Blood test|Blood test
16321858|NCT00485771|Drug|Olanzapine|
16321859|NCT00485771|Drug|Fluoxetine|
16321860|NCT00485771|Drug|Lamotrigine|
16321861|NCT00485758|Drug|ER niacin/laropiprant|One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.
16321862|NCT00485758|Drug|Comparator : placebo (unspecified)|ER niacin/laropiprant Placebo
16321863|NCT00485732|Biological|HPV-16/18 VLP/AS04 vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16321864|NCT00485732|Biological|Placebo|Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
16321865|NCT00485719|Drug|XL765 (SAR245409)|Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
16321866|NCT00485706|Procedure|high calcium dialysate|
16321867|NCT00485693|Drug|Bupivacaine HCl|150 mg Bupivacaine HCl
16321868|NCT00485693|Drug|SKY0402|600 mg SKY0402 (study drug)
16321869|NCT00485680|Drug|Olanzapine Hydrochloride|
16321870|NCT00485680|Drug|Lithium Carbonate|
16321871|NCT00485667|Drug|SKY0402|Subects received either 300mg or 450mg
16321872|NCT00485667|Drug|Moxifloxacin 400mg|
16321873|NCT00485667|Drug|Placebo injection|
16321874|NCT00485667|Drug|Placebo tablet|
16321875|NCT00485641|Device|SaeboFlex Dynamic Hand Orthosis|
16321876|NCT00485641|Procedure|Saebo F.T.M. Arm Training Program|
16321877|NCT00485628|Drug|Atomoxetine Hydrochloride|
16321878|NCT00485615|Drug|Omega 3 Joy enteric coated concentrated fish oil|1500-3000mg; one per day
16321879|NCT00485602|Procedure|"orthodontic treatment with Rafenalign appliance"|
16321880|NCT00485589|Drug|Methotrexate|Oral repeating dose
16321881|NCT00485589|Drug|Ocrelizumab|Intravenous repeating dose
16321882|NCT00485589|Drug|Placebo|Intravenous repeating dose
16321883|NCT00485576|Drug|eculizumab|eculizumab 600 mg or matching placebo iv infusion.
16321884|NCT00485563|Biological|EC90 (KLH-FITC)|1.2mg in combination with adjuvant GPI-0100 administered subcutaneously (beneath the skin) weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
16321885|NCT00485563|Biological|GPI-0100|3.0 mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first cycle of treatment, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
16321886|NCT00485563|Drug|EC17 (Folate-FITC)|0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks for the first two treatment cycles and then 3 days per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
16321887|NCT00485563|Drug|Interleukin-2|7.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 2.5 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
16321888|NCT00485563|Drug|Interferon-alpha|3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 4 consecutive weeks during the first 2 cycles of treatment, then 3.0 MIU administered subcutaneously 3 times per week (Monday, Wednesday, Friday) for 3 consecutive weeks for each additional cycle.
16321889|NCT00485550|Drug|Atomoxetine Hydrochloride|
16321890|NCT00485550|Drug|Methylphenidate Hydrochloride|
16321891|NCT00485550|Drug|Placebo|
16321892|NCT00485537|Procedure|oocyte retrieval and ICSI procedure|
16321893|NCT00485511|Drug|Hydroxyurea|
16321894|NCT00485498|Drug|Olanzapine Hydrochloride|
16321895|NCT00485498|Drug|Risperidone|
16321896|NCT00485485|Drug|Imatinib Mesylate|400 mg by mouth daily
16321897|NCT00485485|Drug|Docetaxel|60 mg/m^2 by vein (IV) over 1 hour every 3 weeks
16321898|NCT00485472|Drug|lacosamide|50 or 100mg tablet, 400mg daily, for 12 weeks
16321899|NCT00485472|Other|Placebo|50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
16321900|NCT00485459|Drug|Atomoxetine Hydrochloride|
16321901|NCT00485459|Drug|Placebo|
16321902|NCT00485446|Procedure|blood analysis|
16321903|NCT00485433|Drug|Bupivacaine HCl|Bupivacaine HCl given during hernia repair
16321904|NCT00485433|Drug|SKY0402|SKY0402 given during hernia repair
16321905|NCT00485420|Other|Internet based disease management program|Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
16321906|NCT00485407|Drug|Atomoxetine Hydrochloride|
16321907|NCT00485394|Drug|OT-551|OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
16321908|NCT00485394|Drug|OT-551|OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
16321909|NCT00485394|Drug|vehicle placebo|OT-551 0% ophthalmic solution, 2 drops 4 times daily
16321910|NCT00485368|Drug|Coversyl (perindopril)|
16321911|NCT00485355|Procedure|conventional laparoscopic hysterectomy|Total laparoscopic hysterectomy
16321912|NCT00485355|Procedure|robotic assisted laparoscopic hysterectomy|Robotic assisted laparoscopic hysterectomy with DaVinci robot
16321913|NCT00485342|Drug|Peg-interferon alpha 2a and ribavin|"Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (1000 mg/day if weight < 75 kg and 1200 mg/day if weight ≥ 75 kg).
~Duration of treatment : 48 weeks Duration of study for patients : 72 weeks"
16321914|NCT00485342|Drug|ribavirin with adaptation dose|"Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (dose adaptation) Dose adaptation : Day 7, dependant of result of AUC Ribavirin dose increments : 200 mg, 400 mg or 600 mg with a maximum of 50% of the initial dose (600 mg) applied every 4 days up to the adjusted dose proposed in order to reach the targeted AUC.
~The maximum daily dose will not exceed 3600 mg Duration of treatment : 48 weeks Duration of study for patients : 72 weeks"
16321915|NCT00485329|Other|Papain|15,000 USP U/ml
16321916|NCT00485329|Other|Papain|30,000 USP U/ml
16321917|NCT00485329|Other|Papain|60,000 USP U/ml
16321918|NCT00485316|Procedure|Laparoscopic assisted resection of colorectal carcinoma|
16321919|NCT00485303|Drug|Abiraterone acetate|Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.
16321920|NCT00485303|Drug|Prednisone|Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.
16321921|NCT00485290|Behavioral|meal (food intake)|600 kcal. (16% protein, 49%carbohydrate, 35% fatt)
16321922|NCT00485277|Biological|MVA-BN-HER2|Experimental vaccine, subcutaneous injection q3weeks x 3
16321923|NCT00485264|Drug|Raltegravir poloxamer film coated tablet|Final Selected Dose: 400-mg tablet taken orally twice daily.
16321924|NCT00485264|Drug|Raltegravir chewable tablet|Final Selected Dose: Weight based dose of ~6 mg/kg according to the dosing table, to a maximum dose of 300 mg, taken orally twice daily.
16321925|NCT00485264|Drug|Raltegravir oral granules for suspension (20 mg/mL)|Weight based dose of ~6 mg/kg orally every 12 hours according to dosing table in protocol or the dose determined by review of all available data.
16321926|NCT00485264|Drug|Raltegravir poloxamer film coated tablet|Final Selected Dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg. Participants < 25 kg were switched to a weight-based dose of the chewable tablet.
16321927|NCT00485251|Procedure|hand-assisted laparoscopic right hemicolectomy|using the lap disc that allows the insertion of single and into the abdomen for operation
16321928|NCT00485251|Procedure|total laparoscopic right hemicolectomy|using laparoscopic instruments for mobilization and dissection inside the abdomen
16321929|NCT00485251|Procedure|hand-assisted right hemicolectomy|hand-assisted right hemicolectomy
16321930|NCT00485251|Procedure|laparoscopic right hemicolectomy|using laparoscopic instruments for mobilization and dissection inside the abdomen
16321931|NCT00485238|Procedure|Argon laser Iridoplasty|
16321932|NCT00485238|Drug|Intravenous acetazolamide|
16321933|NCT00485225|Drug|EN3270|Transdermal Therapeutic System
16321934|NCT00485212|Device|compression bandage|
16321935|NCT00485199|Procedure|Pneumatic Retinopexy|
16321936|NCT00485199|Procedure|Vitrectomy with Gas|
16321937|NCT00485173|Device|INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate|All patients enrolled in this study will receive the investigational device.
16321938|NCT00485160|Drug|Continuous indomethacin|
16321939|NCT00485160|Drug|ibuprofen|
16321940|NCT00485147|Procedure|Recording of GPS during a free walking in a public park|Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.
16321941|NCT00485134|Biological|240 µg Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
16321942|NCT00485134|Biological|480 µg Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
16321943|NCT00485134|Biological|690 Shigella flexneri 2a Invaplex 50 vaccine|Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
16321944|NCT00485134|Other|Shigella challenge strain|300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T
16321945|NCT00485121|Drug|Ezetimibe|
16321946|NCT00485108|Drug|prednisolone 1%|eye drop once in each eye treated, 4 times / day for 5 days post-laser
16321947|NCT00485108|Drug|ketorolac 0.5%|eye drop once in each eye treated, 4 times / day for 5 days post-laser
16321948|NCT00485108|Drug|Artificial Tears (Methyl cellulose drops)|eye drop once in each eye treated, 4 times / day for 5 days post-laser
16321949|NCT00485095|Behavioral|Intake of plant sterols|
16321950|NCT00485069|Drug|ROP|Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.
16321951|NCT00485069|Drug|ROP+L-Dopa|Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
16321952|NCT00485056|Drug|Pioglitazone|45mgs daily
16321953|NCT00485043|Behavioral|Modified T'ai Chi: T'ai Chi for Arthritis|
16321954|NCT00485030|Device|Cypher|sirolimus-eluting stent
16321955|NCT00485030|Device|Xience-V|everolimus-eluting stent
16321956|NCT00485017|Drug|THR-4109|THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
16321957|NCT00485017|Drug|Placebo|Oral capsules daily in a.m. and in p.m. for 24 weeks
16321958|NCT00485004|Device|Cutting balloon|Cutting balloon
16321959|NCT00485004|Device|Sirolimus-eluting stent|Sirolimus-eluting stent
16321960|NCT00484991|Drug|Sapropterin dihydrochloride|20mg/kg/day orally, physicians may adjust the dose within a range of 5-20mg/kg/day as warranted by their clinical judgment.
16321961|NCT00484978|Procedure|Stereotactic Radiosurgery|
16321962|NCT00484965|Procedure|Coronary stenting|
16321963|NCT00484939|Drug|Bevacizumab|Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
16321964|NCT00484939|Drug|Capecitabine|Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
16321965|NCT00484926|Drug|Aspirin monotherapy|stopping clopidogrel at 1 year after DES
16321966|NCT00484926|Drug|Aspirin,Clopidogrel|continue aspirin and clopidogrel 1year after DES
16321967|NCT00484913|Procedure|abdominal hot compress|
16321968|NCT00484900|Drug|Co-Arinate FDC|
16321969|NCT00484900|Drug|Coartem|
16321970|NCT00484874|Drug|I-131 Tositumomab therapeutic regimen|Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
16321971|NCT00484848|Device|Vortex port and Celsite port|
16321972|NCT00484835|Procedure|Performing abdominal hysterectomy using gyrus electrocoagulation forceps|
16321973|NCT00484822|Drug|Bemiparina Sodica|3.500 UI/día.
16321974|NCT00484822|Drug|Heparina Cálcica|10.000 UI/día.
16321975|NCT00484809|Drug|Enbrel (Etanercept)|
16321976|NCT00484796|Procedure|MED-SEP|intraoperative neurophysiological monitoring
16321977|NCT00484796|Procedure|TRI-SEP|intraoperative neurophysiologic monitoring
16321978|NCT00484796|Procedure|neuropsychological tests|neurological short- and longterm outcome
16321979|NCT00484783|Procedure|Natural Orifice Transluminal Endoscopic Surgery (NOTES)|Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
16321980|NCT00484783|Procedure|Natural Orifice Translumenal Endoscopic Surgery (NOTES)|chart review of historical data from control group
16321981|NCT00484770|Device|Brain Natriuretic Peptide Levels -- Diagnostic testing|
16321982|NCT00484770|Other|clinical assessment|
16321983|NCT00484757|Drug|Orexine A|
16321984|NCT00484744|Drug|Acetaminophen|
16321985|NCT00484744|Drug|Avicel (placebo)|
16321986|NCT00484744|Drug|Ibuprofen|
16321987|NCT00484731|Procedure|Infiltration with Saline|Infiltration with Bupivacaine according to protocol
16321988|NCT00484731|Procedure|Infiltration with Bupivacaine|
16321989|NCT00484718|Drug|celecoxib|oral, 100 mg bid
16321990|NCT00484718|Drug|Oxycodone|oral, 20 mg bid
16321991|NCT00484718|Drug|placebo|oral bid
16321992|NCT00484705|Procedure|Electroacupuncture|
16321993|NCT00484705|Procedure|Physical exercise|
16321994|NCT00484705|Procedure|Untreated control|
16321995|NCT00484692|Drug|sustained-release bupropion (Zyban(R))|
16321996|NCT00484692|Behavioral|Psychodynamic Model Training (R) = PDM(R)|
16321997|NCT00484679|Drug|Triamcinolone Acetonide 10 mg/mL (Kenalog-10)|Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
16321998|NCT00484653|Procedure|cervical smear|biological analysis
16321999|NCT00484640|Drug|Coumadin|
16322000|NCT00484627|Procedure|Use of creatine monohydrate (a dietary supplement)|
16322001|NCT00484627|Behavioral|Progressive resistance exercise training|
16322002|NCT00484614|Procedure|Positron Emission Mammography|Molecular Imaging Device
16322003|NCT00484614|Procedure|Magnetic Resonance Imaging|Imaging Device
16322004|NCT00484601|Drug|Ifosfamide|
16322005|NCT00484601|Drug|Doxorubicin|
16322006|NCT00484575|Drug|Sevoflurane|given by infusion via AnaConDa for sedation with target MAAS 2-3
16322007|NCT00484575|Drug|propofol|propofol given intravenously for sedation in control group
16322008|NCT00484562|Device|Standard oxygen delivery system|Standard oxygen tank with pulse dose regulator
16322009|NCT00484562|Device|Homefill oxygen delivery system|Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
16322010|NCT00484562|Device|Helios oxygen delivery system|Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
16322011|NCT00484562|Device|FreeStyle oxygen system|portable battery-powered oxygen concentrator delivery system
16322012|NCT00484549|Procedure|Blood sample|Ischemic stroke hospitalized
16322013|NCT00484536|Drug|CDP323|250 mg capsules, 500 mg bid (1000 mg/day)
16322014|NCT00484536|Drug|placebo|capsules, once daily
16322015|NCT00484536|Drug|CDP323|250 mg Capsules, 500 mg, once daily
16322016|NCT00484523|Procedure|SPET, PET and MRI|60 healthy subjects after a a consultation with a neurologist for wich 4 examinations will be programmed in two days ( 1 cerebral MRI, 1pet scan, 1 spet, 1 datascan
16322017|NCT00484510|Drug|Ascorbic acid (Vitamin C)|Eight 500 mg capsules/day of ascorbic acid. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months. (Total 4 gr/day).
16322018|NCT00484510|Drug|placebo|Eight 500 mg capsules/day of placebo. Subjects will take four (4)capsules each morning and four (4) capsules each evening for 24 months.
16322019|NCT00484497|Drug|cyclamax|
16322020|NCT00484484|Drug|Ketamine|Ketamine
16322021|NCT00484471|Drug|aripiprazole|15-30 mg/day aripiprazole, 22 weeks
16322022|NCT00484471|Drug|valproate|sufficient dose as determined by investigator to maintain the therapeutic level.
16322023|NCT00484471|Drug|placebo|placebo to aripiprazole, 22 weeks
16322024|NCT00484458|Device|Interspinous process and dynamic stabilization (Wallis System)|Interspinous stabilization
16322025|NCT00484458|Device|Total Disc Replacement|Total disc
16322026|NCT00484432|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs
16322027|NCT00484432|Drug|doxorubicin|Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²
16322028|NCT00484419|Drug|Colesevelam HCl|coleveselam tablets 625 mg; 6 tablets/day
16322029|NCT00484419|Drug|rosiglitazone maleate|rosiglitazone tablets 4mg
16322030|NCT00484419|Drug|sitagliptin phosphate|sitagliptin phosphate tablets 100mg/day
16322031|NCT00484393|Drug|tetracaine 4% gel|tetracaine applied prior to 1 injection
16322032|NCT00484393|Drug|Placebo|placebo applied prior to 1 injection
16322033|NCT00484380|Procedure|Coronary scanner|multislice spiral computed tomography coronary angiography
16322034|NCT00484367|Behavioral|Adolescent group therapy|Adolescent group therapy
16322035|NCT00484367|Behavioral|Transitional family therapy|Transitional family therapy
16322036|NCT00484354|Drug|Sodium bicarbonate|IV bicarbonate given with amount based on patient weight
16322037|NCT00484354|Other|Normal saline|IV Normal saline with volume given determined by patient weight
16322038|NCT00484354|Other|Bicarbonate|IV bicarbonate, dosed by weight
16322039|NCT00484354|Other|Placebo|Normal saline, with volume given based on patient weight
16322040|NCT00484341|Drug|low-dose NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
16322041|NCT00484341|Drug|high-dose NGR-hTNF|NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
16322042|NCT00484341|Drug|Doxorubicin|Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion) on day 1 every 3 weeks for a maximum of 6 cycles or until cumulative dose of 550 mg/m²
16322043|NCT00484328|Drug|Ribavirin|different dosing regimes of Ribavirin
16322044|NCT00484315|Device|Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation|TAXUS Element stent placement
16322045|NCT00484315|Device|Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement|TAXUS Express Stent Implant
16322046|NCT00484302|Behavioral|Cognitive behavioral therapy with motivational interviewing|Individual and group therapy, education of family and case-manager.
16322047|NCT00484302|Behavioral|Non-manualized standard treatment|Treatment by case-manager
16322048|NCT00484289|Drug|Abatacept|Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.
16322049|NCT00484276|Drug|NGR-hTNF|iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
16322050|NCT00484263|Drug|Hypertonic saline 6% -|Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
16322051|NCT00484250|Drug|metronidazole,doxycycline|
16322052|NCT00484237|Drug|etanercept|
16322053|NCT00484211|Drug|NGR-hTNF|iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
16322054|NCT00484198|Drug|Pioglitazone|45 mg over-encapsulated tablet administered orally, once daily
16322055|NCT00484198|Drug|Placebo|Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
16322056|NCT00484198|Drug|Rivoglitazone|1.0 mg tablet administered orally, once daily
16322057|NCT00484198|Drug|Rivoglitazone|1.5 mg tablet administered orally, once daily
16322058|NCT00484185|Drug|BeneFIX (coagulation factor IX (recombinant))|BeneFIX will be administered according to physician's discretion.
16322059|NCT00484172|Procedure|blood draws|
16322060|NCT00484159|Procedure|Radiofrequency denervation of medial branches|Radiofrequency of medial branches that innervate the lumbar facet joints
16322061|NCT00484159|Drug|0.5% bupivacaine|Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.
16322062|NCT00484159|Drug|2% lidocaine|Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.
16322136|NCT00483639|Other|Medical chart review|medical chart review
16322063|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation without a diagnostic block
16322064|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.
16322065|NCT00484159|Procedure|Radiofrequency denervation|Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
16322066|NCT00484159|Procedure|Radiofrequency denervation|Radiofrequency lumbar facet denervation without a diagnostic facet block.
16322067|NCT00484133|Drug|Dopamine|
16322068|NCT00484133|Drug|dobutamine|
16322069|NCT00484133|Drug|enoximone|
16322070|NCT00484133|Drug|nitroglycerine|
16322071|NCT00484133|Drug|noradrenaline|
16322072|NCT00484120|Drug|3%-Diclofenac-Nano-Emulsion Cream|3%-Diclofenac-Nano-Emulsion Cream
16322073|NCT00484120|Drug|Placebo cream|Placebo cream
16322074|NCT00484107|Drug|Conjugated Estrogen Cream (Premarin®)|
16322075|NCT00484094|Drug|sirolimus|Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
16322076|NCT00484081|Procedure|Microdissection Testicular Sperm Extraction|
16322077|NCT00484081|Procedure|ICSI|
16322078|NCT00484068|Drug|enalapril|
16322079|NCT00484068|Procedure|chicken diet|
16322080|NCT00484055|Drug|Local application of collagen-gentamicin|Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure
16322081|NCT00484055|Procedure|Fixation of the sternotomy with more than six wires|At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure
16322082|NCT00484029|Drug|Nasal Carbon Dioxide|Nasal Carbon Dioxide
16322083|NCT00484029|Other|Air|Air (Medical Grade)
16322084|NCT00484003|Drug|Pimecrolimus cream 1%|
16322085|NCT00483990|Drug|PSD502|
16322086|NCT00483977|Drug|Oxycodone|Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
16322087|NCT00483977|Drug|Placebo|Placebo: oral for 2 weeks.
16322088|NCT00483977|Drug|PF-000592379|PF-00592379: oral, 30 mg, once a day for 2 weeks
16322089|NCT00483964|Drug|Bacopa monnieri|
16322090|NCT00483964|Drug|Nardostachys jatamansi|
16322091|NCT00483964|Drug|Olanzapine|
16322092|NCT00483951|Device|Toshiba Aquilion ONE CT|The Toshiba Aquilion ONE CT system has the ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy.
16322093|NCT00483951|Device|SWiemens MRI scanner|Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
16322094|NCT00483938|Drug|Pegylated-interferon Alfa-2a|Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
16322095|NCT00483938|Drug|Ribavirin|Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
16322096|NCT00483912|Device|Molecular adsorbent recirculating system|
16322097|NCT00483899|Drug|GW870086X|Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
16322098|NCT00483899|Drug|Placebo|Placebo matching GW870086X will be administered by subjects
16322099|NCT00483886|Drug|Prucalopride|2 mg o.d.
16322100|NCT00483886|Other|Placebo|Placebo o.d.
16322101|NCT00483886|Drug|Prucalopride|4 mg o.d.
16322102|NCT00483860|Drug|Topotecan|once a day
16322103|NCT00483834|Drug|Bevacizumab|7.5mg/kg, IV, day 1 of each cycle
16322104|NCT00483834|Drug|Irinotecan|200mg/m^2, IV, day 1 each cycle
16322105|NCT00483834|Drug|Capecitabine|1000mg/m^2 or 750mg/m^2 for patients over 65yrs old PO BID, day 1-14 each cycle
16322106|NCT00483821|Other|medical chart review|medical chart review
16322107|NCT00483808|Device|Ardian Symplicity™ Catheter|Renal denervation using the Symplicity Catheter
16322108|NCT00483795|Drug|sodium citrate, sodium chloride, sodium borate, propylene glycol. citrate, tetronic 1304, AMP 95|
16322109|NCT00483782|Biological|bevacizumab|
16322110|NCT00483782|Drug|carboplatin|
16322111|NCT00483782|Drug|paclitaxel|
16322112|NCT00483782|Other|questionnaire administration|
16322113|NCT00483782|Other|study of socioeconomic and demographic variables|
16322114|NCT00483782|Procedure|quality-of-life assessment|
16322115|NCT00483769|Drug|Glargine|
16322116|NCT00483756|Drug|Cyclosporine|Standard of care
16322117|NCT00483756|Drug|CP-690,550|CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
16322118|NCT00483756|Drug|CP-690,550|CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
16322119|NCT00483743|Drug|TPI 1020|250 mcg/caps 2 caps BID x 42 days
16322120|NCT00483743|Drug|Budesonide|400mcg mcg capsules- 2 capsules BID
16322121|NCT00483743|Drug|Placebo|2 caps BID x42 days
16322122|NCT00483730|Drug|Deproteinised hemoderivative of calf blood (Actovegin)|Symptomatic diabetic peripheral polyneuropathy
16322123|NCT00483717|Drug|Ketorolac tromethamine|31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
16322124|NCT00483717|Drug|Placebo|Intranasal (IN) placebo
16322125|NCT00483704|Drug|Telcagepant 140 mg|Telcagepant 140 mg tablets
16322126|NCT00483704|Drug|Talcagepant 280 mg|Telcagepant 280 mg tablets
16322127|NCT00483704|Drug|Placebo|Placebo tablets
16322128|NCT00483691|Behavioral|Home Visit|Homw visits scheduled weekly for one year.
16322129|NCT00483678|Other|counseling intervention|
16322130|NCT00483678|Other|questionnaire administration|
16322131|NCT00483678|Procedure|psychosocial assessment and care|
16322132|NCT00483665|Procedure|Computed tomography angiography|Computed tomography angiography
16322133|NCT00483665|Procedure|Magnetic resonance imaging|Magnetic resonance imaging after injection of Vasovist
16322134|NCT00483652|Drug|Fampridine-SR|Tablets, 10 mg, twice daily, 9 weeks
16322135|NCT00483652|Drug|Placebo|placebo (sugar pill)
16322137|NCT00483639|Other|Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory|survey administration
16322138|NCT00483639|Procedure|management of therapy complications|management of therapy complications
16322139|NCT00483639|Procedure|Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID|psychosocial assessment
16322140|NCT00483639|Other|Functional Assessment of Cancer Therapy-General (FACT-G)|survey administration
16322141|NCT00483626|Drug|oral sildenafil|
16322142|NCT00483613|Behavioral|Cognitive-behavioral therapy of Meichenbaum|
16322143|NCT00483600|Drug|fondaparinux|injections of 2.5mg every other day for 4 weeks
16322144|NCT00483587|Drug|Heme arginate|1-3 x heme arginate infusion, in 30 minutes iv. Heme arginate is dissolved in 250 ml NACl.
16322145|NCT00483574|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, IM at age 9 and 12 months
16322146|NCT00483574|Biological|Measles-mumps-rubella-varicella vaccine|0.5 mL, intramuscular at 12 months of age
16322147|NCT00483574|Biological|Routine paediatric vaccine - Pneumococcal conjugate (PCV)|0.5 mL, Intramuscular at age 12 months
16322148|NCT00483574|Biological|Routine paediatric vaccine - Hepatitis A|0.5 mL, Intramuscular at age 12 months
16322149|NCT00483561|Drug|Gefitinib plus etoposide|Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
16322150|NCT00483548|Drug|Ziprasidone|Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
16322151|NCT00483548|Drug|Placebo|Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
16322152|NCT00483535|Drug|GW273225|GW273225 will be available as 25 milligram tablets.
16322153|NCT00483535|Drug|COC|COC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets.
16322154|NCT00483522|Behavioral|Self-management telephone counseling|Subjects are contacted 7 times in year 1 after discharge from hospital rehabilitation unit and 4 times in year 2. Telephone counseling based on a self-management/problem-solving model is conducted by a research care manager.
16322155|NCT00483509|Drug|NGR-hTNF|iv q3W 0.8 mcg/sqm NGR-hTNF
16322156|NCT00483509|Drug|Doxorubicin|iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion
16322157|NCT00483496|Drug|Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)|
16322158|NCT00483496|Drug|Ti02 pigmentary 3% alone (formula RV3131A-MV1211)|
16322159|NCT00483496|Drug|bisoctrizole 10% alone (formula RV3131A-MV1237)|
16322160|NCT00483496|Drug|Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)|
16322161|NCT00483496|Drug|Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)|
16322162|NCT00483496|Drug|Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)|
16322163|NCT00483496|Drug|Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]|
16322164|NCT00483496|Drug|V0096 CR vehicle (formula RV3131A-MV1197)|
16322165|NCT00483483|Behavioral|Individual and group HIV risk behavior counseling sessions|Healthy Relationships Intervention (HRI) culturally adapted and modified to address substance use and associated risk behaviors; subjects will attend three 2-hour structured group sessions in addition to two 1-hour individualized sessions over the course of 10 days.
16322166|NCT00483483|Behavioral|health education and support group|general health information (nutrition, stress reduction) in 2 individual sessions and 3 group sessions.
16322167|NCT00483470|Biological|Hepatitis A vaccine AVAXIM 80U|0.5 mL, Intramuscular
16322168|NCT00483470|Biological|Hepatitis A vaccine (HAVRIX 720)|0.5 mL, Intramuscular
16322169|NCT00483457|Drug|enzyme inhibitor therapy|enzyme inhibitor therapy
16322170|NCT00483457|Genetic|protein expression analysis|protein expression analysis
16322171|NCT00483457|Other|immunohistochemistry staining method|immunohistochemistry staining method
16322172|NCT00483457|Other|laboratory biomarker analysis|laboratory biomarker analysis
16322173|NCT00483457|Procedure|biopsy|biopsy
16322174|NCT00483444|Behavioral|Scheduled telephone follow-up|Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.
16322175|NCT00483431|Dietary Supplement|Placebo|
16322176|NCT00483431|Dietary Supplement|MK7|
16322177|NCT00483405|Biological|cetuximab|250 mg/m2, intravenously, once per week
16322178|NCT00483405|Drug|capecitabine|850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
16322179|NCT00483405|Drug|oxaliplatin|130 mg/m2, intravenously on Day 1 of each 21 day cycle
16322180|NCT00483392|Drug|metformin, rosiglitazone|
16322181|NCT00483379|Biological|alglucosidase alfa|intravenous infusion
16322182|NCT00483366|Drug|capecitabine|"Dose level Capecitabine
~-1 400 mg/m2 bid
~0 500 mg/m2 bid
~500 mg/m2 bid
~600 mg/m2 bid
~600 mg/m2 bid
~725 mg/m2 bid
~725 mg/m2 bid
~850 mg/m2 bid
~850 mg/m2 bid"
16322183|NCT00483366|Drug|gemcitabine hydrochloride|"Dose level Gemcitabine
~-1 400 mg/m2 0 450 mg/m2
~550 mg/m2
~550 mg/m2
~675 mg/m2
~675 mg/m2
~825 mg/m2
~825 mg/m2
~1000 mg/m2"
16322184|NCT00483366|Drug|imatinib mesylate|"Dose level Imatinib
~-1 400 mg/d 0 400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d
~400 mg/d"
16322185|NCT00483366|Genetic|mutation analysis|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
16322247|NCT00482872|Genetic|gene expression analysis|
16322248|NCT00482872|Genetic|mutation analysis|
16322249|NCT00482872|Genetic|polymerase chain reaction|
16322186|NCT00483366|Genetic|nucleic acid sequencing|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
16322187|NCT00483366|Genetic|polymerase chain reaction|C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.
16322188|NCT00483353|Procedure|Intra-nasal allergen challenge with Phleum pratense.|
16322189|NCT00483353|Procedure|Collection of nasal effluent using filter paper.|
16322190|NCT00483353|Procedure|Measurement of nasal congestion using acoustic rhinometry.|
16322191|NCT00483327|Drug|Megestrol Acetate|
16322192|NCT00483314|Drug|N-acetylcysteine|2 g p.o. BID x 60 days
16322193|NCT00483301|Drug|Sorafenib (BAY 43-9006)|dosage
16322194|NCT00483301|Drug|ABI-007(Abraxane)|dosage
16322195|NCT00483288|Other|educational intervention|
16322196|NCT00483288|Other|questionnaire administration|
16322197|NCT00483288|Other|study of socioeconomic and demographic variables|
16322198|NCT00483288|Other|survey administration|
16322199|NCT00483275|Drug|Alfacalcidol|
16322200|NCT00483275|Behavioral|Balance, gait and strength training|
16322201|NCT00483275|Behavioral|Patient education|
16322202|NCT00483262|Drug|CCI-779|Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles
16322203|NCT00483262|Drug|Bortezomib|Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles
16322204|NCT00483249|Device|Endovascular Branched Stent-Graft|Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
16322205|NCT00483223|Drug|Cisplatin|Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
16322206|NCT00483223|Drug|carboplatin|Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
16322207|NCT00483210|Drug|Fenofibrate|
16322208|NCT00483197|Device|VentrAssistTM Left Ventricular Assist Device|
16322209|NCT00483184|Biological|Veldona,|Very low dose oral natural human interferon alpha lozenges
16322210|NCT00483171|Drug|CP-945,598|CP-945,598
16322211|NCT00483171|Behavioral|Non-pharmacological weight loss program (NPP)|Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
16322212|NCT00483171|Behavioral|Low Calorie Diet|Low calorie diet
16322213|NCT00483158|Drug|Finafloxacin hydrochloride|Tablets, oral single dose and multiple dose once daily for 7d
16322214|NCT00483145|Device|Long-pulsed dye laser (Candela) and PDT (methylaminolevulinate)|
16322215|NCT00483145|Device|Long-pulsed dye laser|
16322216|NCT00483145|Device|Long-pulsed dye laser assisted fotodynamic therapy (methylaminolevulinate)|
16322217|NCT00483132|Drug|interferon alpha 2a|
16322218|NCT00483119|Drug|intravenous immunoglobulin|Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
16322219|NCT00483119|Drug|cyclophosphamide|cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
16322220|NCT00483106|Drug|Ritalin|0.25 mg/kg bid, orally for 7 consecutive days
16322221|NCT00483106|Drug|Placebo|taken orally twice a day for 7 consecutive days
16322222|NCT00483093|Drug|NGR-hTNF|iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm
16322223|NCT00483093|Drug|Cisplatin|iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles
16322224|NCT00483080|Drug|NGR-hTNF|iv q3W or q1W NGR-hTNF 0.8 μg/m²
16322225|NCT00483067|Drug|2-CdA|12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
16322226|NCT00483067|Drug|Ara-C|1 gm/m^2/day IV Over 2 Hours x 5 Days
16322227|NCT00483067|Drug|G-CSF (Granulocyte colony-stimulating factor)|5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
16322228|NCT00483054|Drug|efavirenz|efavirenz 600 mg/day + stavudine + lamivudine
16322229|NCT00483054|Drug|nevirapine|nevirapine 400 mg/day + stavudine +lamivudine
16322230|NCT00483041|Other|PLACEBO|Placebo administered as a single intravenous infusion
16322231|NCT00483041|Biological|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
16322232|NCT00483028|Drug|donezepil (Aricept)|
16322233|NCT00483015|Behavioral|smoking|
16322234|NCT00483002|Drug|varenicline|As prescribed by physician in usual clinical practice.
16322235|NCT00482989|Biological|MEDI 545|"MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
~Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
16322236|NCT00482989|Other|Placebo|"Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
~Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."
16322237|NCT00482976|Drug|Ruboxistaurin|
16322238|NCT00482976|Drug|Placebo|
16322239|NCT00482963|Drug|levonorgestrel, efavirenz|
16322240|NCT00482950|Drug|PHX1149T|
16322241|NCT00482937|Drug|CD-NP|
16322242|NCT00482924|Other|Lifestyle intervention|Regular sports and dietary advices. Controlled by analysis of laboratory parameters, BMI change and performance diagnostics. No drugs included so far.
16322243|NCT00482911|Drug|cyclophosphamide|25-50 mg by mouth once daily on days 1-28.
16322244|NCT00482911|Drug|lenalidomide|10 mg by mouth once daily on days 1-28.
16322245|NCT00482911|Drug|sunitinib malate|12.5 - 25 mg by mouth once daily on days 1-28.
16322246|NCT00482898|Drug|MK0359|
16322250|NCT00482872|Genetic|polymorphism analysis|
16322251|NCT00482872|Other|flow cytometry|
16322252|NCT00482872|Other|laboratory biomarker analysis|
16322253|NCT00482846|Biological|Palifermin|Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
16322254|NCT00482846|Drug|melphalan|"Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:
~Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;
~Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:
~Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;"
16322255|NCT00482846|Other|questionnaire administration|Day -5 to Day +28
16322256|NCT00482846|Procedure|autologous peripheral blood stem cell transplantation|Day 0
16322257|NCT00482846|Other|quality-of-life assessment|Day -5 to Day +28
16322258|NCT00482833|Drug|arsenic trioxide|"Induction Arsenic Trioxide (As2O3=ATO), 0.15 mg/Kg IV over 2 hours daily starting on day 1. ATO will be continued until hematological CR or for a maximum of 60 days.
~Consolidation ATO, 0.15 mg/Kg IV over 2 hours daily for 5 days every week. Treatment will be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles (last cycle administered on weeks 25 - 28)."
16322259|NCT00482833|Drug|idarubicin|"Induction
~Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 by short (20') intravenous infusion .
~If no hematological CR is achieved by 60 days after start of induction, patient will go off-study.
~Consolidation
~1st cycle Idarubicin, 5 mg/m2/day by short (20') intravenous infusion on days 1, 2, 3, 4.
~3rd cycle Idarubicin, 12 mg/m2/day as short (20') intravenous infusion only on day 1."
16322260|NCT00482833|Drug|mercaptopurine|Maintenance therapy 6-Mercaptopurine (6-MP), 50 mg/m2/day orally. The dose will be adjusted according to hematopoietic toxicity during the follow-up period
16322261|NCT00482833|Drug|methotrexate|Maintenance therapy Methotrexate (MTX), 15 mg/m2/weekly intramuscularly. The dose will be adjusted according to toxicity during the follow-up period.
16322262|NCT00482833|Drug|all-trans retinoic acid|"Induction ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological CR and for a maximum of 60 days.
~Consolidation
~st cycle ATRA, 45 mg/m2/day, will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~nd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~rd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
~Maintenance therapy
~ATRA, 45 mg/m2/day orally, for 15 days every three months until a two year period is completed."
16322263|NCT00482833|Drug|all-trans retinoic acid (ATRA)|"Induction All-trans retinoic acid (ATRA), 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological complete remission (CR, see below for definition) or for a maximum of 60 days.
~Consolidation ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment. Treatment will be administered for 2 weeks on 2 weeks off and for a total of 7 cycles (last cycle administered on weeks 25 - 26)."
16322264|NCT00482820|Behavioral|attention-bias training|one group recive an attention training away from threat. The second group, the controll group, recive a placebo training
16322265|NCT00482807|Drug|bicalutamide|
16322266|NCT00482807|Drug|docetaxel|
16322267|NCT00482807|Drug|goserelin|
16322268|NCT00482807|Radiation|intensity-modulated radiation therapy|
16322269|NCT00482781|Biological|Infanrix|
16322270|NCT00482781|Biological|Pediatrix|
16322271|NCT00482768|Behavioral|Practice Facilitation|Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.
16322272|NCT00482755|Drug|sunitinib malate|
16322273|NCT00482755|Other|immunohistochemistry staining method|
16322274|NCT00482755|Other|laboratory biomarker analysis|
16322275|NCT00482755|Other|pharmacological study|
16322276|NCT00482755|Procedure|needle biopsy|
16322277|NCT00482755|Procedure|neoadjuvant therapy|
16322278|NCT00482742|Device|CiTop(TM) Guidewire|
16322279|NCT00482729|Drug|sitagliptin phosphate (+) metformin hydrochloride|sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
16322280|NCT00482729|Drug|metformin|metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
16322281|NCT00482716|Biological|epoetin alfa|
16322282|NCT00482716|Biological|epoetin beta|
16322283|NCT00482716|Dietary Supplement|iron dextran complex|
16322284|NCT00482716|Dietary Supplement|iron sucrose injection|
16322285|NCT00482703|Drug|Dasatinib|tablets, Oral, 100 mg, once daily
16322286|NCT00482703|Drug|dasatinib|tablets, Oral, 50 mg, twice daily
16322287|NCT00482690|Drug|nicotine polacrilex|
16322288|NCT00482690|Drug|nicotine transdermal system|
16322289|NCT00482690|Drug|nicotine inhaler|
16322290|NCT00482677|Drug|temozolomide|Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.
16322291|NCT00482677|Genetic|DNA methylation analysis|A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms
16322292|NCT00482677|Procedure|quality-of-life assessment|prior to randomization until end of study
16322293|NCT00482677|Radiation|Radiation|Short course radiotherapy
16322294|NCT00482664|Drug|CP-866,087|Tablets for oral administration
16322295|NCT00482664|Drug|CP-866,087|Tablets for oral administration
16322296|NCT00482664|Drug|CP-866,087|Tablets for oral administration
16322297|NCT00482664|Drug|Placebo|Tablets for oral administration
16322298|NCT00482651|Radiation|Multidetector computed tomography scanning|contrast Multidetector CT-scanning
16322299|NCT00482651|Procedure|Coronary angiography (CAG)|CAG and if necessary PCI. Included patients are already assigned for CAG
16322300|NCT00482651|Procedure|Intravascular ultrasound|During CAG Intravascular Ultrasound will be performed in the three coronary arteries
16322301|NCT00482651|Procedure|Blood sample|a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
16322302|NCT00482638|Drug|MK0493|
16322303|NCT00482625|Drug|erlotinib hydrochloride|Given PO
16322304|NCT00482625|Procedure|conventional surgery|Undergo pancreatectomy
16322305|NCT00482625|Other|immunohistochemistry staining method|Correlative studies
16322306|NCT00482625|Genetic|protein expression analysis|Correlative studies
16322307|NCT00482625|Procedure|biopsy|Correlative studies
16322308|NCT00482625|Other|pharmacological study|Correlative studies
16322309|NCT00482625|Other|laboratory biomarker analysis|Correlative studies
16322310|NCT00482612|Drug|Esmirtazapine|Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
16322311|NCT00482612|Drug|Placebo|Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
16322312|NCT00482599|Drug|Sugammadex|2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
16322313|NCT00482586|Other|medical chart review|Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
16322314|NCT00482586|Other|questionnaire administration|Patients with hepatic neoplasms who undergo Image-guided Therapy
16322315|NCT00482586|Procedure|quality-of-life assessment|Patients with hepatic neoplasms who undergo Image-guided Therapy
16322316|NCT00482573|Procedure|Dental local anesthesia|"2% lidocaine solution with epinephrine 1:100,000
~infusion of 1,8 mL (one cartridge)
~Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)"
16322317|NCT00482573|Procedure|Dental local anesthesia|"2% lidocaine solution without vasoconstrictor
~infusion of 1,8 mL (one cartridge)
~Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)"
16322318|NCT00482560|Drug|Sucrose solution 30%1 ml|
16322319|NCT00482560|Behavioral|Breastfeeding|
16322320|NCT00482547|Device|Hydrogel Silver Salts Coated Latex Urinary Catheter System|Silver-coated catheter
16322321|NCT00482547|Device|Bard silicone elastomer coated latex catheter system|Silicone-coated catheter
16322322|NCT00482521|Drug|CC-4047|Oral CC-4047 once daily on days 1-21 followed by a 7-day recovery period. Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined.
16322323|NCT00482508|Drug|Omalizumab|
16322324|NCT00482495|Biological|bevacizumab|
16322325|NCT00482495|Genetic|gene expression analysis|
16322326|NCT00482495|Genetic|protein expression analysis|
16322327|NCT00482495|Other|laboratory biomarker analysis|
16322328|NCT00482482|Behavioral|psychoeducation|on weekly basis for 8 weeks
16322329|NCT00482482|Behavioral|Yoga|on weekly basis for 8 weeks
16322330|NCT00482456|Drug|Nitrous oxide|
16322331|NCT00482443|Other|A software programme in mobile telephone|Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
16322332|NCT00482443|Other|Standard Education Programme.|Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
16322333|NCT00482430|Drug|MK0557|MK0557 10mg tablet qd for a 15-wk treatment period
16322334|NCT00482430|Drug|Comparator: Placebo (unspecified)|MK0557 Pbo tablet qd for a 15-wk treatment period
16322335|NCT00482417|Drug|MK0359|
16322336|NCT00482404|Behavioral|Romantic kissing|
16322337|NCT00482391|Biological|trastuzumab|
16322338|NCT00482391|Drug|cyclophosphamide|
16322339|NCT00482391|Drug|doxorubicin hydrochloride|
16322340|NCT00482391|Drug|lapatinib ditosylate|
16322341|NCT00482391|Drug|paclitaxel|
16322342|NCT00482391|Other|laboratory biomarker analysis|
16322343|NCT00482378|Drug|Pamidronate|90 mg by IV monthly.
16322344|NCT00482378|Drug|Zoledronic acid|4 mg by IV monthly.
16322345|NCT00482378|Radiation|Sm 153 lexidronam|0.5 mCi/kg or 1 mCi/kg by IV.
16322346|NCT00482365|Other|biologic sample preservation procedure|biologic sample preservation procedure
16322347|NCT00482365|Other|medical chart review|review of patients' medical records at study entry and every 6 months
16322348|NCT00482365|Other|Patient interview|Elicit demographic data as well as information about personal habits such as drinking and smoking.
16322349|NCT00482352|Other|laboratory biomarker analysis|Correlative studies
16322350|NCT00482313|Drug|PR OROS Methylphenidate|PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.
16322351|NCT00482313|Drug|Placebo|Sugar pill
16322352|NCT00482300|Procedure|Systematic pelvic lymphadenectomy|
16322353|NCT00482287|Drug|MTR105|Intravenous administration, dose escalating (4 arms), single dose
16322354|NCT00482274|Drug|docetaxel|Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
16322355|NCT00482261|Drug|Lenalidomide|15mg daily, days 1-21 of a 28 day cycle for 4 cycles. Patients who get stable disease or better will then receive 15mg on days 1-21 from cycle 5 onwards
16322356|NCT00482261|Drug|dexamethasone|20mg day 1-4, 9-12, 17-20 for 4 cycles. Patients who get stable disease or better will then get dexamethasone 20mg on days 1-4 of a 28 day cycle, from cycle 5 onwards
16322357|NCT00482261|Drug|aspirin|100mg/day
16322358|NCT00482248|Drug|Omalizumab|
16322359|NCT00482235|Drug|MK0359|
16322365|NCT00482222|Other|study of socioeconomic and demographic variables|
16322366|NCT00482222|Procedure|adjuvant therapy|
16322367|NCT00482222|Procedure|neoadjuvant therapy|
16322368|NCT00482222|Procedure|quality-of-life assessment|
16322369|NCT00482209|Drug|Mifepristone, misoprostol|200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
16322370|NCT00482209|Drug|mifepristone, misoprostol|200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
16322371|NCT00482196|Drug|MK0493|
16322372|NCT00482183|Drug|Pioglitazone|
16322373|NCT00482170|Device|Enbrel (etanercept)|Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
16322374|NCT00482170|Device|Etanercept|Arm 2 = Enbrel 50 mg Autoinjector twice weekly
16322375|NCT00482157|Drug|Vitamin D (Calcitriol)|
16322376|NCT00482144|Procedure|PDL 450 microseconds|The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.
16322377|NCT00482144|Procedure|PDL 1.5 milliseconds|The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.
16322378|NCT00482105|Other|EGIR Tape|Tape stripping is a non-invasive method that allows the recovery of cells
16322379|NCT00482092|Drug|adult human mesenchymal stem cells|Intravenous infusion of suspension of adult human mesenchymal stem cells, total of 1200 million (high dose) or 600 million (low dose) cells infused in four visits over two weeks.
16322380|NCT00482092|Drug|Placebo|Placebo
16322381|NCT00482079|Drug|MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks|
16322382|NCT00482079|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks|
16322383|NCT00482066|Drug|Abatacept (Orencia)|"500mg for patients under 60kg 750mg for patients 60-100kg
~1g for patients>100kg given as i.v. infusion over 30 minutes at day 0, 14, 28 and then monthly for a further 11 months 914 infusions in total) placebo groups receive saline only I.v."
16322384|NCT00482053|Procedure|Autologous hematopoietic stem cell transplantation (auto-HSCT)|Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
16322385|NCT00482053|Procedure|Allogeneic hematopoietic stem cell transplantation (allo-HSCT)|Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
16322386|NCT00482053|Procedure|Total lymphoid irradiation (TLI)|TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
16322387|NCT00482053|Drug|Rituximab|375 mg/m2 IV days 1 and 7 over 4 to 8 hours
16322388|NCT00482053|Drug|Carmustine|"Based on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours.
~Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)"
16322389|NCT00482053|Drug|Etoposide|60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization)
16322390|NCT00482053|Drug|Filgrastim|10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery
16322391|NCT00482053|Drug|Anti-thymocyte globulin (ATG)|1.5 mg/kg/day for 5 days
16322392|NCT00482053|Drug|Cyclosporine|5.0 mg/kg twice daily from day -3 until after day +56
16322393|NCT00482053|Drug|Mycophenolate mofetil (MMF)|"250 mg (total) twice daily, oral
~15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor."
16322394|NCT00482053|Drug|Cyclophosphamide|100 mg/kg will be administered over 2 hours on day -2
16322395|NCT00482053|Drug|Acetaminophen|Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
16322396|NCT00482053|Drug|Diphenhydramine|Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion
16322397|NCT00482053|Drug|Hydrocortisone|Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
16322398|NCT00482053|Drug|Methylprednisolone|Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7
16322399|NCT00482040|Device|Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP|
16322400|NCT00482027|Biological|tgAAC09|one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
16322401|NCT00482014|Drug|pemetrexed|"Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles
~Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles
~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase"
16322402|NCT00482014|Drug|cisplatin|"Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43
~Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles"
16322403|NCT00482014|Drug|carboplatin|"Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43
~Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles"
16322404|NCT00482014|Radiation|radiation therapy|"Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51
~Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45"
16322405|NCT00482001|Drug|donepezil|
16322406|NCT00482001|Drug|Placebo (cornstarch)|
16322407|NCT00481988|Device|transcranial direct current stimulation|Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.
16322408|NCT00481988|Device|transcranial direct current stimulation|transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.
16322409|NCT00481988|Device|transcranial direct current stimulation|one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
16322410|NCT00481988|Device|iomed phoresor transcranial direct current stimulation|for the sham group the current is turned off after 10 seconds
16322411|NCT00481975|Drug|rimonabant (SR141716)|
16322412|NCT00481962|Drug|Tygacil|Initial dose of 100mg followed by 50mg every 12 hours for 5 to 14 days
16322413|NCT00481936|Drug|VB6-845|Intravenous infusion once weekly for 4 weeks
16322414|NCT00481923|Drug|rimonabant (SR141716)|
16322415|NCT00481897|Behavioral|low-fat, vegan diet|Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.
16322416|NCT00481884|Other|RadiaPlexRx Gel|RadiaPlexRx Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply RadiaPlexRx gel topically 3 Times Daily to one half of the irradiated breast skin and the control, Aquaphor gel, to the other half of irradiated breast skin. This is determined through randomization process.
16322417|NCT00481884|Other|Aquaphor Gel|Aquaphor Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply Aquaphor gel topically 3 Times Daily to one half of the irradiated breast skin and the experimental, RadiaPlexRx gel, to the other half of irradiated breast skin. This is determined through randomization process.
16322418|NCT00481871|Drug|Pralatrexate Injection|"Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).
~Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.
~Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
16322419|NCT00481871|Drug|Gemcitabine Hydrochloride|"Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.
~Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.
~Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
16322420|NCT00481871|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
16322421|NCT00481871|Dietary Supplement|Folic Acid|"1 mg orally
~Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate."
16322422|NCT00481845|Drug|Vandetanib|300 mg daily
16322423|NCT00481845|Drug|Anastrozole|1 mg daily
16322424|NCT00481832|Drug|Cyclophosphamide|4 gm /m² IV over 2 hours on day 8
16322425|NCT00481832|Drug|BCNU|"The dose of BCNU will be based on actual body weight unless the actual body weight is more than 15 kg greater than the ideal body weight in which case the adjusted ideal body weight will be used:
~Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)"
16322426|NCT00481832|Drug|Etoposide|60mg/kg, IV over 4 hours on day -4 pre-transplant and for preparative regimen. The dose of etoposide for mobilization is 2 gm/ m².
16322427|NCT00481832|Drug|Filgrastim|10µg/kg sc qd starting day following cyclosphamide (or VP-16) until last day of apheresis
16322428|NCT00481832|Drug|Antithymocyte globulin|1.5 mg/kg/d, IV from day -11 to -7
16322429|NCT00481832|Drug|Cyclosporine|5mg/kgbid,variable, po or IV
16322430|NCT00481832|Drug|Mycophenolate mofetil|15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. Thereafter, beginning on day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor. Doses will be rounded up to the nearest 250 mg (capsules are 250 mg). MMF will be stopped on day +28 for matched related donors. For one antigen mismatched related or unrelated donors, the taper will begin on day +40. MMF will be tapered by 10% weekly till off, typically by day +96. If there is nausea and vomiting at any time preventing the oral administration of MMF, MMF should be administered intravenously at an equal dose. MMF dosing is based on actual body weight.
16322431|NCT00481832|Drug|Rituximab|375 mg/m2 IV (calculated based on actual body weight) on day 1 and day 7. Administered per current standard of care..
16322432|NCT00481832|Procedure|Autologous hematopoietic stem cell transplantation (auto-HSCT)|Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
16322433|NCT00481832|Procedure|Allogeneic hematopoietic stem cell transplantation (allo-HSCT)|Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
16322434|NCT00481832|Procedure|Total lymphoid irradiation|TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
16322435|NCT00481832|Drug|CD34+ Cells|2 x 10e6 CD34+ cells per kg actual body weight on Day 0
16322436|NCT00481832|Drug|Solu-Medrol|1 mg/kg, Day-11 to Day-7
16322437|NCT00481819|Drug|FK506MR|oral
16322438|NCT00481819|Drug|Prograf|oral
16322439|NCT00481819|Drug|Mycophenolate Mofetil|oral
16322440|NCT00481819|Drug|Methylprednisolone|oral
16322441|NCT00481819|Drug|Prednisolone|oral
16322442|NCT00481780|Device|plain balloon angioplasty|
16322443|NCT00481780|Device|cutting balloon angioplasty|
16322444|NCT00481767|Biological|Cervarix|The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
16322445|NCT00481767|Drug|Placebo Al(OH)3|Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
16322446|NCT00481741|Device|SafeSeal(TM) Hemostasis Patch|
16322447|NCT00481728|Drug|Tolterodine|Single dose per patient as determined by protocol.
16322448|NCT00481728|Procedure|Filling cystometry|This is a procedure.
16322449|NCT00481728|Procedure|Intravesical neurostimulation|This is a procedure.
16322450|NCT00481715|Behavioral|Web-Based Weight Loss Program|Participants will take part in a Web-based weight loss program.
16322451|NCT00481715|Behavioral|Cash Incentive Weight Loss Program|Participants will take part in a cash incentive weight loss program.
16322452|NCT00481702|Drug|Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks|
16322453|NCT00481702|Drug|MK0826, /Duration of Treatment : 8 Weeks|
16322454|NCT00481702|Drug|Comparator: metronidazole / Duration of Treatment: 8 Weeks|
16322455|NCT00481689|Drug|Cipro XR (Ciprofloxacin, BAYQ3939)|Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days
16322456|NCT00481676|Drug|Omalizumab 75-375 mg|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
16322457|NCT00481676|Drug|Placebo to omalizumab|Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
16322458|NCT00481676|Drug|Loratadine|All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
16322459|NCT00481676|Drug|Clemastine|All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
16322460|NCT00481663|Drug|Sitagliptin|
16322461|NCT00481663|Drug|Placebo to sitagliptin|
16322462|NCT00481663|Drug|Metformin|
16322463|NCT00481663|Drug|Rescue|Patients whose FPG >240 mg/dL from Week 16 or HbA1C >8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently >240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C >8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C >7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.
16322464|NCT00481650|Drug|Leios/Alesse|
16322465|NCT00481624|Drug|Epoetin Alfa plus Iron|"One (1) injection of Procrit®, by needle, inserted just under the skin;
~125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.
~These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.
~In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan."
16322466|NCT00481598|Procedure|magnet resonance spectroscopy|magnet resonance spectroscopy
16322467|NCT00481572|Drug|Terlipressin|continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
16322468|NCT00481572|Drug|Vasopressin|continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
16322469|NCT00481572|Drug|Norepinephrine|titrated norepinephrine over a period of 48 hrs
16322470|NCT00481559|Drug|Voraxaze (glucarpidase)|50 Units/kg in a bolus intravenous injection over 5 minutes
16322471|NCT00481546|Genetic|rAAV2-CBSB-hRPE65|One or two, uniocular, subretinal injections; relative doses: 0.3X (Cohort 1), 0.6X (Cohort 2), 0.45X (Cohort 3), 0.9X (Cohorts 4 and 5)
16322472|NCT00481533|Drug|Methyl-Ergonovine-Oxytocin|
16322473|NCT00481533|Drug|Oxytocin|
16322474|NCT00481520|Drug|SAM-531|
16322475|NCT00481520|Other|placebo|
16322476|NCT00481507|Other|Kefir|The intervention was Kefir,a drink that is commercially available in the United States. The following probiotics are present in the Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150mL) everyday.
16322477|NCT00481507|Other|Placebo|The intervention was Kefir, a drink that is commercially available in the United States. The following probiotics are present in active Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. The placebo group was heat-treated to kill all cultures. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150 mL)everyday.
16322478|NCT00481481|Drug|tacrolimus|immunosuppression
16322479|NCT00481455|Drug|Panzem NCD|2000 mg q8h, continuous dosing in 28 day cycles
16322480|NCT00481455|Drug|Temozolomide|Fixed dose
16322481|NCT00481442|Drug|Phenylephrine|
16322482|NCT00481429|Drug|Rosiglitazone|Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
16322483|NCT00481416|Device|PillCam Eso|
16322484|NCT00481403|Behavioral|Microarray analysis|Microarray analysis
16322485|NCT00481403|Behavioral|Microarray|Microarray
16322486|NCT00481390|Procedure|Cheek cells sample|Cheek cells sample
16322487|NCT00481390|Procedure|Blood sample|Blood sample
16322488|NCT00481377|Procedure|ablation|
16322489|NCT00481364|Drug|atorvastatin|atorvastatin 40 mg/day
16322490|NCT00481364|Drug|placebo|1 tb/day
16322491|NCT00481351|Drug|Simvastatin 20mg plus ezetimibe 10mg|simvastatin 20mg plus ezetimibe 10mg once a day for 6 week.
16322492|NCT00481351|Drug|ezetimibe|ezetimiba 10mg once a day
16322493|NCT00481351|Drug|simvastatin 20mg|simvastatin 20mg once a day
16322494|NCT00481351|Drug|Simvastatin 80mg|simvastatin 20mg for 6week and then simvastatin 80mg for the next 6week.
16322495|NCT00481338|Procedure|X-rays|X-rays (hip and knee) every 2 years
16322496|NCT00481338|Biological|biological samples|biological sample (blood and urine) every 2 years
16322610|NCT00480441|Behavioral|BRENDA therapy|weekly therapy sessions for 6 weeks
16322497|NCT00481338|Other|medical information about osteoarthritis|several questionnaires about pain and function (WOMAC), physical activity (MAQ), quality of life (generic SF-36 and OA specific OAKHQOL/AMIQUAL), comorbidities (FCI), mental status (MMS), heath status (GHQ 28) and health resource consumption
16322498|NCT00481325|Drug|pexacerfont|Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
16322499|NCT00481325|Drug|escitalopram|Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
16322500|NCT00481325|Drug|placebo|Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
16322501|NCT00481312|Drug|Dexmedetomidine|Continuous Infusion
16322502|NCT00481312|Drug|Midazolam|Continuous Infusion
16322503|NCT00481286|Behavioral|Improving outcomes using group clinics for older patients|Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.
16322504|NCT00481286|Behavioral|Standard of Care|Standard of care for diabetes patients
16322505|NCT00481273|Drug|Azacitidine|Physician's discretion
16322506|NCT00481260|Procedure|Medical history and basic laboratory analysis|Medical history and basic laboratory analysis
16322507|NCT00481247|Drug|Dasatinib|Tablets, oral, dasatinib 50-140 mg once daily (QD)
16322508|NCT00481247|Drug|Imatinib|Tablets, oral, imatinib 200-800 mg, QD
16322509|NCT00481234|Device|Heart Rate Variability analysis|
16322510|NCT00481221|Procedure|Observation of results from laboratory tests|Laboratory data summary only
16322511|NCT00481195|Drug|Armodafinil|Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
16322512|NCT00481195|Drug|Placebo|Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
16322513|NCT00481182|Drug|fosamprenavir + ritonavir + methadone|
16322514|NCT00481169|Drug|Bazedoxifene Acetate (TSE-424)|
16322515|NCT00481156|Behavioral|Cognitive Remediation|
16322516|NCT00481156|Behavioral|Cognitive Behavioral Social Skills Training|
16322517|NCT00481156|Other|Retest in Health Controls|Pre/Post test performance and neuroimaging only
16322518|NCT00481143|Drug|ICL670/Deferasirox|
16322519|NCT00481117|Drug|LY2405319|
16322520|NCT00481117|Drug|Placebo|
16322521|NCT00481104|Drug|Tesofensine|
16322522|NCT00481091|Drug|ABT-263|Tablet; Oral
16322523|NCT00481078|Drug|vorinostat|Given PO
16322524|NCT00481078|Drug|paclitaxel|Given IV
16322525|NCT00481078|Drug|carboplatin|Given IV
16322526|NCT00481078|Other|placebo|Given PO
16322527|NCT00481078|Other|laboratory biomarker analysis|Correlative studies
16322528|NCT00481065|Biological|MF59-eH5N1|
16322529|NCT00481065|Biological|eTIV_a|
16322530|NCT00481065|Biological|MF59-eH5N1 + eTIV_a|
16322531|NCT00481052|Drug|Nilotinib|
16322532|NCT00481039|Procedure|Medical history and basic laboratory analysis|Medical history and basic laboratory analysis
16322533|NCT00481026|Device|transcranial direct current stimulation (tDCS)|tDCS
16322534|NCT00481026|Device|active tDCS|Active tDCS
16322535|NCT00481013|Drug|Valproic Acid (VPA)|Drug: Valproic Acid and Levocarnitine; capsules
16322536|NCT00481013|Drug|Placebo|For six months, pts are randomized into placebo or treatment. After 6 months, all pts are on treatment
16322537|NCT00481000|Behavioral|Dialectical Cognitive Therapy|Dialectical Behavior Therapy in Combination with Traumafocused CBT
16322538|NCT00480987|Drug|Oxaliplatin|30 mg/m^2 IV days 1-4
16322539|NCT00480987|Drug|Fludarabine|30 mg/m^2 IV days 2-6
16322540|NCT00480987|Drug|Cytarabine|500 mg/m^2 by IV continuous infusion days 2-6
16322541|NCT00480974|Other|Clinical follow up and laboratory analysis|Clinical follow up and laboratory analysis
16322542|NCT00480961|Procedure|intramiocardiac autograft of autologous stem cells|
16322543|NCT00480948|Behavioral|Infant formula feeding (InFat™)|Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk
16322544|NCT00480948|Dietary Supplement|Control|Standard vegetable oil based infant formula
16322545|NCT00480935|Drug|Sunitinib Malate (Sutent)|Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week washout period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period.
16322546|NCT00480922|Behavioral|Low glycemic load diet|Outpatient behavioral counseling
16322547|NCT00480922|Behavioral|Low fat diet|Outpatient behavioral counseling
16322548|NCT00480896|Drug|tacrolimus ointment|Topical application
16322549|NCT00480896|Drug|Placebo ointment|Topical application
16322550|NCT00480883|Drug|meglumine antimoniate, allopurinol|first drug in injectable, second is in tablet form.
16322551|NCT00480883|Drug|meglumine antimoniate|injectable 20 mg/kg/day/intramuscular for 21 days.
16322611|NCT00480441|Drug|Placebo|4 capsules daily for 2 weeks followed by a 1 week taper
16322552|NCT00480883|Drug|meglumine antimoniate, allopurinol|injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.
16322553|NCT00480870|Drug|donepezil|donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
16322554|NCT00480870|Drug|Placebo|Placebo 1p / day for 1 month and 2 / day for 5 months on
16322555|NCT00480857|Drug|Docetaxel (Taxotere)|Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
16322556|NCT00480844|Drug|Sertindole|Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.
16322557|NCT00480844|Drug|Risperidone|Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.
16322558|NCT00480831|Drug|bevacizumab|Intravenous repeating dose
16322559|NCT00480831|Drug|carboplatin|Intravenous repeating dose
16322560|NCT00480831|Drug|paclitaxel|Intravenous repeating dose
16322561|NCT00480831|Drug|placebo|Intravenous repeating dose
16322562|NCT00480831|Drug|PRO95780|Intravenous repeating dose
16322563|NCT00480818|Drug|SAM-531|
16322564|NCT00480805|Drug|MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks|
16322565|NCT00480805|Drug|Comparator : ramipril /Duration of Treatment : 8 Weeks|
16322566|NCT00480792|Biological|GenHevac B Pasteur|Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
16322567|NCT00480792|Biological|GenHevac B Pasteur|Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
16322568|NCT00480792|Biological|GenHevac B Pasteur|GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
16322569|NCT00480779|Behavioral|GLB Group|The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
16322570|NCT00480779|Behavioral|GLB DVD|The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and weekly telephone contact with a trained lifestyle coach.
16322571|NCT00480766|Drug|MK0217/Duration of Treatment : 12 Months|
16322572|NCT00480753|Drug|Nitroglycerin|
16322573|NCT00480740|Drug|Dexmedetomidine|Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
16322574|NCT00480727|Procedure|Halo pin re-tensioning|Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
16322575|NCT00480727|Procedure|Placebo Re-tensioning|Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
16322576|NCT00480714|Biological|BCG (SSI Strain)|
16322577|NCT00480701|Drug|[123I]-IBVM|Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours.
16322578|NCT00480688|Biological|BCG|
16322579|NCT00480675|Procedure|trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine|Depomedrol 60 mg + bupivacaine 2.5 ml
16322580|NCT00480675|Procedure|Trochanteric bursa injection with depomedrol and bupivacaine|Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.
16322581|NCT00480662|Drug|alendronate|Duration of Treatment : 6 Months
16322582|NCT00480649|Drug|Salmeterol/ fluticasone propionate|2 active arms (parellel group)
16322583|NCT00480636|Drug|Fragmin (dalteparin sodium )|Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
16322584|NCT00480623|Drug|Satraplatin plus radiation therapy|
16322585|NCT00480610|Drug|tacrolimus ointment|Topical application
16322586|NCT00480610|Drug|Placebo ointment|Topical application
16322587|NCT00480597|Drug|gemcitabine|
16322588|NCT00480597|Drug|cisplatin|
16322589|NCT00480597|Drug|vinorelbine|
16322590|NCT00480597|Drug|capecitabine|
16322591|NCT00480584|Drug|gemcitabine|Levels 1 through 4: 1000 mg/m^2
16322592|NCT00480584|Drug|capecitabine|Level 1: 500 mg/m^2; Level 2: 825 mg/m^2; Level 3: 1000 mg/m^2; Level 4: 1250 mg/m^2
16322593|NCT00480584|Drug|erlotinib|Levels 1 through 4: 100 mg
16322594|NCT00480571|Drug|BL-1020|BL-1020 Low Dose
16322595|NCT00480571|Drug|BL 1020 High Dose|BL 1020 High Dose
16322596|NCT00480558|Biological|MVA 85A|Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
16322597|NCT00480532|Drug|Lybrel|All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
16322598|NCT00480532|Drug|Doxycycline|100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline.
16322599|NCT00480532|Drug|Oracea|40-mg tablet daily for 84 days
16322600|NCT00480532|Drug|Placebo|Placebo pill orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of placebo
16322601|NCT00480532|Drug|Doxycycline 100bid x5 days at the time of bleeding|Doxycycline 100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline
16322602|NCT00480532|Drug|Subantimicrobial doxycycline daily|Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study
16322603|NCT00480532|Drug|placebo daily|Placebo daily for the first 84 days of the study
16322604|NCT00480519|Procedure|Meatotomy|
16322605|NCT00480493|Behavioral|STEP|Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
16322606|NCT00480480|Behavioral|Trauma and Grief Component Therapy for Adolescents (Group Version)|
16322607|NCT00480467|Drug|SAM-315|
16322608|NCT00480454|Biological|MVA 85A|intradermal vaccine
16322609|NCT00480441|Drug|Dronabinol|10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week
16322612|NCT00480402|Drug|200 mg of Progesterone|Administration of 200 mg of Progesterone
16322613|NCT00480402|Drug|400 mg Progesterone|Administration of 400 mg Progesterone
16322614|NCT00480402|Drug|Placebo|Administration of a Placebo
16322615|NCT00480389|Drug|Sorafenib|Starting dose: 400 mg (2x200mg tablets) BID (total= 800mg/day) taken orally. The dose can be adjusted as per investigator if required due to toxicity (ex. 200mg BID, 200mg QD). Study drug is taken for 12 weeks preoperatively. Patients restart on study drug 6 weeks postoperatively and continue until progression or unacceptable toxicity occurs.
16322616|NCT00480376|Drug|ofloxacin|
16322617|NCT00480376|Drug|gentamicin|
16322618|NCT00480363|Procedure|Maintenance with lower doses of lenalidomide and dexamethasone|After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
16322619|NCT00480350|Behavioral|rice based food supplement|
16322620|NCT00480337|Procedure|In Vitro Maturation of immature oocytes|
16322621|NCT00480324|Biological|Rotarix|Two-dose oral vaccination.
16322622|NCT00480324|Biological|Placebo|Two-dose oral administration.
16322623|NCT00480311|Other|WHODAS II (World Health Organization Disability Assessment Schedule II)|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).
16322624|NCT00480298|Drug|Administration of oral methylprednisolone|
16322625|NCT00480285|Procedure|Laparoscopic Nissen Fundoplication|
16322626|NCT00480285|Procedure|Laparoscopic anterior partial fundoplication|
16322627|NCT00480272|Drug|adalimumab, plus prednisone|adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day
16322628|NCT00480272|Drug|adalimumab plus placebo|adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
16322629|NCT00480259|Behavioral|hyperproteic nutrition|
16322630|NCT00480246|Drug|BL 1020|
16322631|NCT00480246|Drug|Perphenazine|
16322632|NCT00480220|Procedure|Global care and support program|
16322633|NCT00480207|Dietary Supplement|folic acid|
16322634|NCT00480207|Dietary Supplement|omega-3|
16322635|NCT00480207|Dietary Supplement|vit B12|
16322636|NCT00480207|Other|folic acid placebo|
16322637|NCT00480207|Other|omega-3 placebo|
16322638|NCT00480194|Drug|xylometazoline hydrochloride and ipratropium bromide (ZyComb)|Common cold in a real-life OTC setting
16322639|NCT00480181|Drug|nabilone|Cesamet (nabilone) capsules given at titrating dosages as per protocol.
16322640|NCT00480181|Other|placebo|placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.
16322641|NCT00480155|Biological|Frozen FluMist®|Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
16322642|NCT00480155|Other|Placebo|
16322643|NCT00480142|Drug|Oxycodone 10 mg|
16322644|NCT00480129|Behavioral|Probiotic or placebo yogurt consumed daily|
16322645|NCT00480129|Device|Mini Rhinoconjunctivitis Quality of Life Questionnaire|
16322646|NCT00480129|Procedure|Blood sample|
16322647|NCT00480129|Procedure|Nasal lavage|
16322648|NCT00480116|Biological|Adjuvanted Hepatitis B vaccine Lot 1|20 µg, IM, month 0 and 1
16322649|NCT00480116|Biological|Adjuvanted Hepatitis B vaccine Lot 2|20µg, IM, month 0 and 1
16322650|NCT00480116|Biological|Adjuvanted Hep B vaccine Lot 3|20µg, IM, month 0 and 1
16322651|NCT00480103|Device|in vivo (ANECOVA D-1) or in vitro culture in 25-µl droplets of cleavage medium (Medicult®) under paraffin oil|
16322652|NCT00480090|Drug|Cytarabine|Initially given at 1g/m2 bid for 2 days every 3 weeks over 2 hours. The dose will be escalated: level 1 - 1.25g/m2, level 2, 1.5g/m2.
16322653|NCT00480077|Device|Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )|OptiVol® Fluid status Monitoring with Cardiac Compass
16322654|NCT00480064|Drug|Lomustine, intermediate dose cytarabine|
16322655|NCT00480051|Device|Cardiac Resynchronization Pacing|
16322656|NCT00480038|Other|WHODAS II|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
16322657|NCT00480025|Biological|GSK1572932A Antigen-Specific Cancer Immunotherapeutic|Intramuscular administration, 13 doses
16322658|NCT00480025|Biological|Placebo Control|Intramuscular administration, 13 doses
16322659|NCT00480012|Device|rTMS|repetitive transcranial meagnetic stimulation of the brain
16322660|NCT00479999|Drug|VRC-HIVADV027-00-VP|
16322661|NCT00479999|Drug|VRC-HIVADV038-00-VP|
16322662|NCT00479986|Drug|pioglitazone|
16322663|NCT00479986|Drug|placebo|
16322664|NCT00479973|Dietary Supplement|Cinnamonforce|"Cinnamonforce™ is a proprietary blend of Cinnamomum aromaticum and Cinnamomum verum bark containing 47 mg of hydroethanolic extract (min. 8% total phenolics) and 23 mg supercritical extract (min. 35% cinnamaldehyde) per capsule.
~2 capsules after the two largest meals of the day"
16322665|NCT00479973|Dietary Supplement|Placebo|Placebo. 2 capsules after the two largest meals of the day
16322666|NCT00479960|Behavioral|commercially available omega-3 fatty acids supplementation|
16322667|NCT00479947|Drug|Probiotics (Natural product)|
16322668|NCT00479947|Drug|Probiotics (L. rhamnosus GR-1 and L. reuteri RC-14)|
16322669|NCT00479934|Drug|imatinib mesylate|6 month treatment with 400mg/day (per os)
16322670|NCT00479921|Biological|Trivalent influenza subunit vaccine|
16322671|NCT00479908|Drug|Sildenafil citrate|
16322672|NCT00479908|Drug|Glyceryl trinitrate|
16322673|NCT00479895|Drug|Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)|Pre-oxygenated HBOC-201
16322674|NCT00479882|Drug|Comparator: simvastatin|
16322675|NCT00479882|Drug|MK-0524A|Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
16322676|NCT00479882|Drug|Placebo|
16322677|NCT00479882|Drug|MK-0524B|
16322678|NCT00479856|Drug|Lapatinib|Small molecule tyrosine kinase inhibitor
16322679|NCT00479856|Drug|Capecitabine|Chemotherapy
16322680|NCT00479856|Drug|Docetaxel|Chemotherapy
16322681|NCT00479856|Drug|nab-Paclitaxel|Chemotherapy
16322682|NCT00479843|Behavioral|Nutritional programme|
16322739|NCT00479440|Drug|SAM-315|
16322683|NCT00479830|Behavioral|Focus Groups|Eight Focus Groups Consisting of 8-10 Members Each
16322684|NCT00479830|Behavioral|Questionnaire|To collect data to assess the unmet health and cancer needs of the South Asian population in the Greater Houston area and to determine barriers and other factors that affect health in this population.
16322685|NCT00479830|Behavioral|Interview|To collect data to assess the unmet health and cancer needs of the South Asian population in the Greater Houston area and to determine barriers and other factors that affect health in this population.
16322686|NCT00479817|Drug|AMG 386|10mg/kg
16322687|NCT00479817|Drug|AMG 386|3 mg/kg
16322688|NCT00479817|Drug|Paclitaxel|Paclitaxel 80 mg/m2 IV QW (3 on/1 off)
16322689|NCT00479817|Drug|AMG 386 Placebo|AMG 386 Placebo
16322690|NCT00479804|Device|inertgas rebreathing|determination of cardiac output by inertgas rebreathing
16322691|NCT00479804|Device|spirometry|spirometry for testing the ventilatory function
16322692|NCT00479804|Device|cardiac magnetic resonance imaging (CMR)|CMR examination which delivers the hemodynamic reference parameters
16322693|NCT00479791|Behavioral|Test meals rich in different fatty acids|
16322694|NCT00479778|Drug|Bazedoxifene/conjugated estrogens|
16322695|NCT00479765|Drug|OncoGel (ReGel/Paclitaxel)|OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
16322696|NCT00479752|Drug|FOLFOX4 (Oxaliplatin), Cetuximab|"Arm A FOLFOX4:
~Oxaliplatin 85 mg/m² d1
~Leucovorin 200 mg/m² d1+d2, followed by
~Bolus 5FU 400 mg/m², followed by
~Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks
~Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m².
~Arm B FOLFOX4:
~Oxaliplatin 85 mg/m² d1
~Leucovorin 200 mg/m² d1+d2, followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks
~Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks."
16322697|NCT00479739|Drug|Salmeterol/fluticasone propionate or formoterol/budesonide|
16322698|NCT00479726|Drug|duloxetine hydrochloride|
16322699|NCT00479713|Drug|ezetimibe (+) simvastatin|ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
16322700|NCT00479713|Drug|Comparator : rosuvastatin calcium|rosuvastatin 10mg. The treatment duration will be 6 weeks.
16322701|NCT00479713|Drug|Comparator: Placebo (unspecified)|rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
16322702|NCT00479713|Drug|Comparator: Placebo (unspecified)|ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
16322703|NCT00479700|Drug|SAM-531|
16322704|NCT00479687|Device|SUPARTZ®|Three Supartz injections over 2 weeks into the glenohumeral joint space.
16322705|NCT00479687|Device|Phosphate Buffered Saline|Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
16322706|NCT00479674|Drug|Abraxane|100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
16322707|NCT00479674|Drug|Bevacizumab|10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
16322708|NCT00479674|Drug|Carboplatin|area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
16322709|NCT00479661|Drug|Dexmedetomidine|Continuous infusion
16322710|NCT00479661|Drug|Propofol|Continuous infusion
16322711|NCT00479648|Biological|CSL412|
16322712|NCT00479648|Biological|Inactivated trivalent influenza vaccine|
16322713|NCT00479635|Drug|TPI 287|160 mg/m2 every three weeks for six cycles
16322714|NCT00479635|Drug|TPI 287|160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
16322715|NCT00479622|Drug|TRU-015|Arm 1 = 800 mg Arm 2 = 2000 mg
16322716|NCT00479609|Drug|Transdermal testosterone therapy|testosterone 1% hydroalcohol gel
16322717|NCT00479609|Drug|Placebo|Placebo gel
16322718|NCT00479596|Drug|Botox|
16322719|NCT00479583|Drug|BMS-690514 / FOLFIRI|Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
16322720|NCT00479583|Drug|BMS-690514 / FOLFOX|Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
16322721|NCT00479570|Drug|PF-00446687|Single 200mg dose
16322722|NCT00479570|Drug|Placebo|
16322723|NCT00479557|Biological|ACC-001 + QS-21|Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
16322724|NCT00479557|Biological|ACC-001|Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
16322725|NCT00479557|Biological|QS-21|QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
16322726|NCT00479557|Drug|Placebo: Phosphate buffered saline|Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
16322727|NCT00479531|Device|AirCast Sequential Compression Device|
16322728|NCT00479505|Drug|UK-369,003|UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
16322729|NCT00479505|Drug|Placebo|Placebo
16322730|NCT00479492|Drug|CP-866,087|1 mg of CP-866,087, administered QD for 84 days
16322731|NCT00479492|Drug|CP-866,087|5 mg of CP-866,087, administered QD for 84 days
16322732|NCT00479492|Drug|CP-866,087|10 mg of CP-866,087, administered QD for 84 days
16322733|NCT00479492|Drug|placebo|placebo administered QD for 84 days
16322734|NCT00479479|Drug|Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)|an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
16322735|NCT00479466|Drug|MK0893|MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
16322736|NCT00479466|Drug|Metformin|Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
16322737|NCT00479466|Drug|Placebo to MK0893|Dose-matched placebo tablets to MK0893; taken orally once daily.
16322738|NCT00479466|Drug|Placebo to Metformin|Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
16322740|NCT00479427|Drug|GW842166|100 mg once daily
16322741|NCT00479427|Drug|Placebo|once daily
16322742|NCT00479401|Drug|Pramipexol Extended Release|
16322743|NCT00479401|Drug|Pramipexol Immediate Release|
16322744|NCT00479401|Drug|Placebo|
16322745|NCT00479388|Drug|Comparator: simvastatin|simvastatin (20mg to 40mg) for 12 weeks.
16322746|NCT00479388|Drug|niacin (+) laropiprant|One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
16322747|NCT00479388|Drug|Comparator: atorvastatin calcium|atorvastatin calcium (20mg to 40mg) for 12 weeks.
16322748|NCT00479375|Procedure|Adding Human Papillomavirus testing to organised cervical screening|
16322749|NCT00479362|Drug|Warfarin|Warfarin is either interrupted or uninterrupted prior to device implantation
16322750|NCT00479362|Drug|Aspirin|Aspirin is continued without interruption prior to device implantation
16322751|NCT00479362|Device|Permanent pacemaker|Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
16322752|NCT00479362|Device|Implantable Cardioverter-defibrillator|Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.
16322753|NCT00479349|Drug|SAM-531|Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.
16322754|NCT00479336|Drug|OPC-41061 7.5mg|7.5mg, 1 tablet a day
16322755|NCT00479336|Drug|OPC-41061 placebo|placebo, 1 tablet a day
16322756|NCT00479336|Drug|OPC-41061 15mg|15mg, 1 tablet a day
16322757|NCT00479336|Drug|OPC-41601 30mg|30mg, 1 tablet a day
16322758|NCT00479323|Biological|Pneumovax 23|Licensed pneumococcal vaccine (Pneumovax 23).
16322759|NCT00479310|Drug|Summers 5% L.A.|
16322760|NCT00479297|Drug|SAM-531|
16322761|NCT00479284|Procedure|Average volume assured pressure support (AVAPS)|
16322762|NCT00479271|Behavioral|Home based, flexible, stepped care intervention|Home based, flexible, stepped care intervention
16322763|NCT00479271|Behavioral|Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.|Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.
16322764|NCT00479258|Drug|Inhaled insulin (Exubera)|Inhaled insulin with dose adjusted according to premeal blood glucose
16322765|NCT00479258|Drug|Subcutaneous Insulin (subject's prescribed)|Subcutaneous insulin with dose adjusted according to premeal blood glucose
16322766|NCT00479245|Other|Set of questionnaires (respondent)|To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
16322767|NCT00479232|Drug|vorinostat|
16322768|NCT00479232|Drug|decitabine|
16322769|NCT00479219|Drug|GSI-953|
16322770|NCT00479219|Other|Placebo|
16322771|NCT00479206|Drug|Artesunate|
16322772|NCT00479193|Drug|bacitracin/xeroform|single layer, change every 3 days
16322773|NCT00479193|Drug|Polymem|single layer of Polymen, change every 3 days
16322774|NCT00479180|Biological|Vascugel|One time implant on the day of surgery
16322775|NCT00479180|Biological|Placebo Comparator|One time implant on the day of surgery
16322776|NCT00479167|Drug|Bortezomib and Tositumomab I-131|
16322777|NCT00479154|Drug|Botulinum Toxin A|Maximum dose of 90 units/leg was injected.
16322778|NCT00479141|Behavioral|HIV skills training|Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
16322779|NCT00479141|Behavioral|Popular Opinion Leaders training|Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
16322780|NCT00479128|Drug|Bortezomib|Starting dose: 0.8 mg/m^2 IV Over 3-5 Seconds
16322781|NCT00479128|Drug|Gemcitabine|Starting dose: 225 mg/m^2 IV Up to 90 Minutes
16322782|NCT00479128|Drug|Doxorubicin|Starting dose: 12.5 mg/m^2 IV Over 15-30 minutes
16322783|NCT00479115|Drug|AMD3100|240 mcg/kg subcutaneously, minimum of two days; maximum of eight days
16322784|NCT00479115|Device|AmCell CliniMACs|CD34+ cell selection from peripheral collection
16322785|NCT00479102|Drug|Ferripel-3 - iron polysaccharide complex for prevention|
16322786|NCT00479089|Drug|Docetaxel|25 mg/m2 IV over 30 minutes for 4 weeks, followed by 2 weeks off therapy.
16322787|NCT00479089|Drug|ZD1839|250 mg by mouth daily, without break.
16322788|NCT00479089|Drug|Dexamethasone|"Course #1: 3 doses of prophylactic Dexamethasone 4mg orally every 12 hours, starting the night before the Docetaxel infusion.
~Course #2: If no hypersensitivity reactions and no significant fluid retention during course 1, the Dexamethasone is reduced to 4mg orally twice daily on the day of therapy.
~Course #3 and subsequent courses: If no hypersensitivity reactions and no significant fluid retention during course 2, the Dexamethasone is reduced to 4mg orally one hour before treatment."
16322789|NCT00479076|Drug|aflibercept (AVE0005)|intravenous infusion
16322790|NCT00479076|Drug|S-1|oral administration
16322791|NCT00479050|Procedure|chemoembolization ,Radiofrequency ablation|
16322792|NCT00479037|Drug|Full Length Parathyroid Hormone, PTH(1-84)|Once daily subcutaneous injection in the abdomen by self administration
16322793|NCT00479037|Drug|Strontium Ranelate|The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water
16322794|NCT00479024|Drug|iodinated contrast agent|iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque
16322795|NCT00479011|Procedure|fluid management based on arterial pulse pressure variation|
16322796|NCT00478998|Drug|Tamsulosin|
16322797|NCT00478985|Behavioral|Imatinib ending|Interruption of the treatment by Imatinib
16322798|NCT00478972|Drug|Rimonabant|Tablet, oral administration
16322799|NCT00478972|Drug|placebo (for Rimonabant)|Tablet, oral administration
16322800|NCT00478972|Other|Diet and exercise|Target daily caloric intake: Ideal body weight × 25 kcal
16322843|NCT00478556|Drug|Gastroview|Oral CT contrast
16322801|NCT00478959|Drug|Lenalidomide (Revlimid®)|25mg PO daily for 21 out of 28days per cycle
16322802|NCT00478946|Drug|(FOLPI) Picoplatin with 5-FU and Leucovorin|Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
16322803|NCT00478946|Drug|FOLPI|Picoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
16322804|NCT00478946|Drug|FOLFOX|Oxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.
16322805|NCT00478933|Device|Defibrillator, Dual Chamber ; Implantable|Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.
16322806|NCT00478933|Procedure|Blood sampling|Blood sampling
16322807|NCT00478907|Drug|KETAMINE, PROPOFOL, THIOPENTAL|
16322808|NCT00478881|Drug|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
16322809|NCT00478881|Drug|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
16322810|NCT00478855|Drug|Tazocin (Piperacillin/Tazobactem)|
16322811|NCT00478842|Device|Deep brain stimulation|Deep brain stimulation
16322812|NCT00478816|Biological|Fluad H5N1 Pandemic Influenza Vaccine|Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.
16322813|NCT00478803|Procedure|Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty|"Remodeling procedure associated with a subvalvular aortic ring: a) Five U stitches are placed inside out in the subvalvular plane (3 stitches 2 mm below the nadir of insertion of each cusp, 2 stitches below 2 of the 3 commissures at the base of the interleaflet triangles (no suture is placed at the base of the interleaflet triangle situated between the right and noncoronary sinuses to avoid injury of the bundle of His)); b) remodeling of the aortic root by scalloping a bulged graft (Gelweave ValsalvaTM); c) The 5 anchoring U stitches are passed through the inner aspect of the prosthetic aortic ring and tied down externally in the subvalvular position; d) anastomosis of the coronary ostia and to distal ascending aorta."
16322814|NCT00478803|Device|Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots|Expansible Prosthetic Aortic Ring: Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
16322815|NCT00478790|Device|ologen™ Collagen matrix implantation in glaucoma filtering surgery|ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
16322816|NCT00478777|Drug|Lenalidomide|Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.
16322817|NCT00478777|Drug|dexamethasone|Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.
16322818|NCT00478764|Drug|intraocular triamcinolone and gatifloxicin|
16322819|NCT00478738|Drug|GSK961081|
16322820|NCT00478725|Drug|GW786034, oral|oral, 800 mg
16322821|NCT00478725|Drug|GW786034, IV|IV, 5 mg
16322822|NCT00478725|Drug|GW786034, radiolabeled oral|oral, 400 mg radiolabeled
16322823|NCT00478712|Other|Identification of genetic causes of Hirschsprung Disease|Blood, saliva, or DNA samples are requested from all study participants. The blood or saliva samples are used to isolate DNA in all participants. Blood samples are also used to establish cell lines in some participants.
16322824|NCT00478699|Drug|Docetaxel/Cisplatin|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
16322825|NCT00478699|Drug|Docetaxel|Docetaxel 75 mg/m2 day 1, 4 cycles
16322826|NCT00478699|Drug|Gemcitabine/Cisplatin|Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
16322827|NCT00478699|Drug|Docetaxel/Cisplatin|Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
16322828|NCT00478686|Procedure|Phlebotomy|5 to 7.5 milliliter (mL) Blood Sample
16322829|NCT00478673|Device|NexStent Carotid Stent System (Monorail Delivery System)|Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
16322830|NCT00478673|Device|FilterWire EZ™ Embolic Protection System|Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
16322831|NCT00478660|Drug|adalimumab (Humira)|
16322832|NCT00478647|Biological|GA-GCB (velaglucerase alfa)|15-60 U/kg, every other week via intravenous infusion
16322833|NCT00478634|Drug|RAD001, Cetuximab, Irinotecan|
16322834|NCT00478621|Biological|GSK Biologicals' HPV vaccine (GSK1674330A)|Intramuscular administration, 5 different formulations
16322835|NCT00478621|Biological|Cervarix TM|Intramuscular administration
16322836|NCT00478608|Drug|Sirolimus (Rapamune®)|(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.
16322837|NCT00478595|Drug|Rimonabant|Tablet, oral administration
16322838|NCT00478595|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16322839|NCT00478595|Drug|Anti-diabetic monotherapy|Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
16322840|NCT00478582|Procedure|Estimation of Hb concentrations with the HemoHue card|
16322841|NCT00478569|Drug|Parathyroid Hormone (PTH) (1-84)|Adherence to PTH(1-84) treatment in Usual Clinical Settings
16322842|NCT00478556|Drug|Omnipaque|Oral CT contrast
16322845|NCT00478530|Procedure|ELECTRORETINOGRAM|Bevacizumab 1.25 mg/0.05 ml unilaterally into the vitreous cavity as part of the standard management for choroidal neovascular AMD. ERG responses form both eyes will be measured at baseline and 1 month after intravitreal injection
16322846|NCT00478517|Drug|Erythropoetin (rHuEPO, EPREX®)|
16322847|NCT00478504|Drug|Letrozole|Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
16322848|NCT00478504|Drug|Clomifene citrate|Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
16322849|NCT00478478|Procedure|Mechanical Thrombectomy|Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.
16322850|NCT00478465|Drug|valganciclovir|
16322851|NCT00478452|Biological|DC-Ova|
16322852|NCT00478452|Biological|DC Ova with Cyclophosphamide|
16322853|NCT00478439|Dietary Supplement|ZeaVision EyePromise Restore|Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,
16322854|NCT00478439|Dietary Supplement|Multivitamin|Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,
16322855|NCT00478426|Drug|Sunitinib Malate|Given PO
16322856|NCT00478387|Biological|The current season's trivalent killed influenza vaccine|
16322857|NCT00478374|Drug|Sorafenib|Sorafenib 400mg bid
16322858|NCT00478374|Procedure|Transarterial chemoembolisation with doxorubicin|Transarterial chemoembolisation (TACE)
16322859|NCT00478361|Drug|Gemcitabine hydrochloride|Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days.
16322860|NCT00478361|Drug|Paclitaxel|135 mg/m^2 IV over 1 hour
16322861|NCT00478361|Drug|Doxorubicin hydrochloride|Doxorubicin 40 mg/m^2 IV over 20 minutes
16322862|NCT00478361|Drug|Pegfilgrastim|Subcutaneously injection on day 1.
16322863|NCT00478348|Procedure|Prosthetic repair of abdominal incisional hernia|Rives-Stoppa repair of incisional hernia
16322864|NCT00478335|Drug|sildenafil|25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight
16322865|NCT00478335|Drug|calcitonin|one nasal spray daily for 4 days
16322866|NCT00478335|Drug|hydrochlorothiazide/amiloride|25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight
16322867|NCT00478335|Drug|indomethacin|50 mg QD or 50 mg BID x 8 days depending on subject weight
16322868|NCT00478335|Drug|Placebo for sildenafil|one tablet daily for 4 days
16322869|NCT00478335|Drug|placebo for calcitonin|one nasal spray daily
16322870|NCT00478322|Drug|Placebo|Matching placebo of 100 mg BID
16322871|NCT00478322|Drug|INCB013739|INCB013739 100 mg BID
16322872|NCT00478309|Other|counseling intervention|
16322873|NCT00478309|Other|educational intervention|
16322874|NCT00478283|Other|survey administration|
16322875|NCT00478270|Drug|ibandronate [Bondronat]|6mg iv on days 1-3
16322876|NCT00478257|Device|bright white light|Intervention: Bright white light administered for 30 minutes each morning
16322877|NCT00478257|Device|comparator red light treatment|dim red light administered for 30 minutes every morning
16322878|NCT00478244|Drug|busulfan|Day -9 through Day -6: 1.1 mg/kg if < 12 kg IV every 6 hours; 0.8 mg/kg if > 12 kg.
16322879|NCT00478244|Drug|cyclophosphamide|Day -5 through Day -2: 50 mg/kg IV over 120 min.
16322880|NCT00478244|Drug|fludarabine phosphate|Day -5 through Day -3: 25 mg/m2 IV over 60 min.
16322881|NCT00478244|Procedure|hematopoietic bone marrow transplantation|allogeneic bone marrow, peripheral stem cell or umbilical cord blood transplantation
16322882|NCT00478231|Drug|Maraviroc|Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.
16322883|NCT00478218|Drug|cyclophosphamide|300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
16322884|NCT00478218|Drug|dexamethasone|40 mg administrated by PO (with food)on Days 1, 8, 15 & 22
16322885|NCT00478218|Drug|lenalidomide|25 mg administrated by PO (with food)on Days 1-21
16322886|NCT00478205|Drug|Aricept (donepezil SR 23 mg)|"Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
~23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation."
16322887|NCT00478205|Drug|Aricept (donepezil IR 10 mg)|"Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:
~10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation."
16322888|NCT00478192|Drug|Conivaptan|premix bag
16322889|NCT00478192|Drug|Placebo|premix bag
16322890|NCT00478179|Drug|Transdermal/Patch (Bupivacaine TTS [Eladur™])|
16322891|NCT00478140|Biological|trastuzumab|For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.
16322892|NCT00478140|Other|laboratory biomarker analysis|Correlative studies
16322893|NCT00478114|Drug|sorafenib|sorafenib in the patients with advanced Renal Cell Carcinoma
16322894|NCT00478101|Drug|oxycodone fentanyl|
16322895|NCT00478088|Device|NeoDisc|The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
16322896|NCT00478088|Device|Instrumented Anterior Cervical Discectomy and Fusion (ACDF)|Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
16322897|NCT00478075|Drug|bortezomib|
16322898|NCT00478075|Other|immunologic technique|
16322899|NCT00478075|Radiation|samarium Sm 153 lexidronam pentasodium|
16322900|NCT00478062|Biological|Hodgkin's antigens-GM-CSF-expressing cell vaccine|
16322901|NCT00478062|Procedure|adjuvant therapy|
16322902|NCT00478049|Drug|Gefitinib|250 mg oral tablet
16322903|NCT00478049|Drug|Docetaxel|intravenous infusion
16322904|NCT00478036|Drug|Acular LS|Details covered in arm description
16322905|NCT00478036|Drug|Pred Forte|Details covered in arm description
16322906|NCT00478036|Other|Refresh Tears|Placebo
16322907|NCT00478023|Drug|Morphine|20 mg IR; 4 - 6 hourly; Total 72 hours
16322908|NCT00478023|Drug|CG5503 IR|50mg; 4 - 6 hourly; Total 72 hours
16322909|NCT00478023|Drug|CG5503 IR|75mg; 4 -6 hourly; Total 72 hours
16322910|NCT00478023|Drug|CG5503 IR|100mg, 4 - 6 hourly; Total 72 hours
16322911|NCT00478023|Drug|Placebo|4 - 6 hourly; Total 72 hours
16322912|NCT00478010|Other|counseling intervention|
16322913|NCT00478010|Other|study of socioeconomic and demographic variables|
16322914|NCT00478010|Procedure|psychosocial assessment and care|
16322915|NCT00478010|Procedure|quality-of-life assessment|
16322916|NCT00477997|Device|Physiological Bolus of Growth Hormone|0,5 mg Norditropin
16322917|NCT00477984|Drug|alcohol|alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
16322918|NCT00477971|Biological|filgrastim|No administration information given
16322919|NCT00477971|Drug|dexamethasone|Given orally
16322920|NCT00477971|Drug|melphalan|Given IV or orally
16322921|NCT00477971|Procedure|autologous hematopoietic stem cell transplantation|Given on day 0
16322922|NCT00477958|Other|questionnaire administration|Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
16322923|NCT00477958|Procedure|cognitive assessment|Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
16322924|NCT00477958|Procedure|psychosocial assessment and care|Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
16322925|NCT00477945|Drug|clofarabine|"Cohort N Clofarabine (mg/m2/day)
~3-6 30
~3-6 40
~3-6 50
~3-6 60
~6-10 70"
16322926|NCT00477906|Biological|M-Vax- autologous, hapten-modified melanoma vaccine|Autologous, DNP-modified melanoma cells in suspension Dose: 12+-8 million cells Route: intradermal Frequency: weekly X7 + 6 month booster
16322927|NCT00477893|Drug|Adalimumab|sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
16322928|NCT00477893|Drug|Placebo|sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
16322929|NCT00477880|Biological|Cetuximab|
16322930|NCT00477867|Procedure|quality-of-life assessment|
16322931|NCT00477854|Drug|Chromium Picolinate|Test whether Chromium Picolinate supplementation affects food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later among healthy, overweight and/or obese, adult women who are determined to be carbohydrate creavers.
16322932|NCT00477841|Procedure|Esophageal stent placement|
16322933|NCT00477841|Procedure|dysphagia scores|
16322934|NCT00477841|Procedure|complications of therapy|
16322935|NCT00477841|Procedure|survival time of therapy|
16322936|NCT00477828|Device|Continuous positive airway pressure|
16322937|NCT00477815|Biological|rituximab|375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22)
16322938|NCT00477815|Drug|melphalan|100/m2 in 1000 ml 0.9% NaCI IV infusion over 1 hour daily x 2 days.
16322939|NCT00477815|Biological|Stem Cell|greater than or equal to 2 x 106 CD34+/kg by IV
16322940|NCT00477815|Biological|Sargramostim (GM-CSF)|500 mcg by Subcutaneous QD
16322941|NCT00477815|Radiation|90Y-Zevalin|Dose escalation scheme. The dose of Zevalin will be based on the calculated radiation to the liver.
16322942|NCT00477815|Biological|111In Zevalin|5.0 mCi by IV
16322943|NCT00477802|Biological|Botulinum Toxin Type A|Injected once during the course of the study.
16322944|NCT00477802|Biological|Placebo|Injected once during the course of the study.
16322945|NCT00477789|Drug|allopurinol|
16322946|NCT00477776|Drug|Metoclopramide (Maxolon)|Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12
16322947|NCT00477776|Drug|Placebo|Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12
16322948|NCT00477763|Drug|Restasis, Refresh Endura|"Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
~Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening"
16322949|NCT00477750|Drug|lenalidomide|"Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression
~Phase II - 10 mg orally days 1-21 every 28 days until progression"
16322950|NCT00477750|Drug|melphalan|"Phase I - dose escalating: 5mg/m^2 dose level -1, 5 mg/m^2 dose level 0, 8 mg/m^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression
~Phase II - 5mg/m^2 orally days 1-4 every 28 days until progression"
16322951|NCT00477750|Drug|prednisone|60mg/m^2, orally days 1-4 every 28 days until progression
16322952|NCT00477737|Drug|Sevoflurane|
16322953|NCT00477737|Drug|propofol|
16322954|NCT00477724|Behavioral|exercise and respiratory therapy|exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
16322955|NCT00477724|Other|sedentary control group|control group with no specific training
16322956|NCT00477711|Drug|cetuximab, cisplatin, capecitabine|Product 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously
16322957|NCT00477685|Device|OculusGen Biodegradable Collagen Matrix Implant|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
16322958|NCT00477672|Drug|Pimavanserin tartrate (ACP-103)|10 mg, tablet, once daily by mouth, 6 weeks
16322959|NCT00477672|Drug|Pimavanserin tartrate (ACP-103)|40 mg, tablet, once daily by mouth, 6 weeks
16322960|NCT00477672|Drug|Placebo|tablet, once daily by mouth, 6 weeks
16322961|NCT00477659|Drug|donepezil HCl (Aricept)|Oral donepezil 5mg/day for 4 weeks, followed by 10 mg/day for 8 weeks
16322962|NCT00477646|Behavioral|Prevention Care Management|Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
16322963|NCT00477633|Drug|Norethindrone/ethinyl estradiol|1 tablet per day
16322964|NCT00477620|Behavioral|Wearing of reading glasses during prolonged near work|
16322965|NCT00477607|Drug|alpha-lipoic acid|Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
16322966|NCT00477607|Behavioral|Audiology|otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
16322967|NCT00477607|Biological|laboratory biomarker analysis|Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
16322968|NCT00477607|Drug|Placebo|Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
16322969|NCT00477594|Drug|mipomersen sodium|200 mg/ml, in 1 ml solution for subcutaneous injection.
16322970|NCT00477581|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
16322971|NCT00477581|Drug|sitagliptin|oral administration (100mg), once a day in the morning
16322972|NCT00477555|Device|Aortic implantation of Mosaic Ultra porcine bioprosthesis|All patients get implanted with a Mosaic Ultra tissue valve to evaluate hemodynamic performance at 6 months post implant.
16322973|NCT00477542|Drug|clofarabine|"Cohort- n- Clofarabine (mg/m2/day)
~-1 3-10 20
~3-6 30
~3-6 40
~3-6 50
~3-6 60
~6-10 70"
16322974|NCT00477529|Drug|ABI-008|nab-docetaxel
16322975|NCT00477516|Procedure|exposure to a high-calcium dialysate bath|Subjects are exposed to a high calcium (3.5 mEq/L) dialysate bath for 150 minutes (part 1). At defined timepoints (0, 45, 90, and 150 min) blood is sampled for calcium, PTH, phosphorous, and FGF-23. At another (later) dialysis session (part 2), the process is repeated except that the subjects are exposed to a normal calcium bath (2.5 mEq/L). For each subject, results from part 1 are compared to the results from part 2.
16322976|NCT00477503|Drug|Gallium-67 Citrate (Ga-67)|"Group A: Ga-67 citrate injection alone, in the baseline study.
~Group B: Ga-67 and In 111 DTPA injection in the baseline study.
~Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study."
16322977|NCT00477503|Drug|In-111 DTPA (In-111 pentetate)|"Group B: Ga-67 and In 111 DTPA injection in the baseline study.
~Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study."
16322978|NCT00477490|Drug|desmopressin acetate|Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
16322979|NCT00477490|Drug|Placebo|Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
16322980|NCT00477477|Other|Diet|Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
16322981|NCT00477477|Other|Diet|Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
16322982|NCT00477464|Drug|Lapatinib|1250mg once daily
16322983|NCT00477464|Drug|capecitabine|2000mg/m^2 twice daily (14 days out of 21 days)
16322984|NCT00477451|Drug|Inhaled placebo|Inhaled Staccato Alprazolam Placebo
16322985|NCT00477451|Drug|Inhaled alprazolam 1 mg|Inhaled Staccato Alprazolam 1 mg
16322986|NCT00477451|Drug|Inhaled alprazolam 2 mg|Inhaled Staccato Alprazolam 2 mg
16322987|NCT00477451|Drug|IV doxapram|0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
16322988|NCT00477412|Drug|Bortezomib|Given IV
16322989|NCT00477412|Drug|Cyclophosphamide|Given IV
16322990|NCT00477412|Drug|Cytarabine|Given IV
16322991|NCT00477412|Drug|Dexamethasone|Given PO or IV
16322992|NCT00477412|Drug|Doxorubicin|Given IV
16322993|NCT00477412|Drug|Methotrexate|Given IV
16322994|NCT00477412|Biological|Rituximab|Given IV
16322995|NCT00477412|Drug|Vincristine|Given IV
16322996|NCT00477399|Behavioral|The Evje Model|
16322997|NCT00477386|Drug|decitabine|"Decitabine dose will be escalated as follows.
~Dose level 1: 10mg/m2 IV QD X 5 days Dose level 2: 20mg/m2 IV QD X 5 days Dose level -1: Carboplatin AUC 4."
16322998|NCT00477373|Drug|depakine chrono|Depakine Chrono 500 mg
16322999|NCT00477360|Device|Humeral surface replacement hemiarthroplasty (CAP)|C.A.P hemiarthroplasty
16323000|NCT00477347|Device|Closed loop administration|intraoperative closed loop administration of propofol and remifentanil
16323001|NCT00477347|Device|Manual administration|intraoperative manual administration of propofol and remifentanil
16323002|NCT00477334|Drug|Famciclovir|oral; two 500 mg tablets twice a day; single day treatment
16323003|NCT00477334|Drug|Placebo|oral; two tablets twice a day; single day treatment
16323004|NCT00477321|Drug|CYT 107|3 dose levels: 3, 10 and 20µg/kg/week.3administrations
16323005|NCT00477308|Procedure|salvage therapy|
16323006|NCT00477295|Drug|Zonisamide|Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
16323007|NCT00477295|Drug|Carbamazepine|Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
16323008|NCT00477282|Drug|Karenitecin|Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
16323009|NCT00477282|Drug|Topotecan|Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
16323010|NCT00477269|Drug|Imatinib mesylate|
16323011|NCT00477269|Drug|Placebo|
16323012|NCT00477256|Behavioral|Questionnaires|5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
16323013|NCT00477243|Behavioral|Questionnaire|8 questionnaires will take about 40 minutes to complete.
16323014|NCT00477230|Device|Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
16323015|NCT00477230|Drug|Standard Anti-arrhythmic Drug (AAD) Therapy|Medication as prescribed by physician.
16323016|NCT00477217|Drug|Zoledronic acid|
16323017|NCT00477204|Drug|Simvastatin|simvastatin 20 mg daily
16323018|NCT00477204|Drug|Ezetimibe/Simvastatin|Ezetimibe (10mg)/Simvastatin (20mg)
16323019|NCT00477191|Drug|Etanercept|TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
16323020|NCT00477165|Drug|Citalopram|20mg/day for 4 weeks, then 40 mg/day for 4 weeks
16323021|NCT00477165|Drug|Placebo|Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks
16323022|NCT00477152|Drug|hyaluronidase (human recombinant)/rehydration fluid|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
16323023|NCT00477126|Drug|GPO ritonavir versus Norvir|RTV generic compared to reference drugs (Norvir, Abbott)
16323024|NCT00477100|Procedure|Biospecimen Collection|Undergo collection of blood, tissue, and stool
16323025|NCT00477100|Other|Interview|Participate in interview
16323026|NCT00477100|Other|Medical Chart Review|Undergo collection of medical data
16323027|NCT00477100|Other|Questionnaire Administration|Ancillary Studies
16323028|NCT00477087|Drug|Mitoxantrone|Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
16323029|NCT00477087|Drug|GM-CSF|GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
16323030|NCT00477074|Procedure|bronchoalveolar lavage, blood analysis|
16323031|NCT00477061|Drug|Morphine|
16323032|NCT00477048|Drug|Saquinavir|SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
16323033|NCT00477035|Drug|CIK cells|2x10e8 cells/kg
16323034|NCT00477035|Drug|etoposide|60 mg/kg
16323035|NCT00477035|Drug|bcnu|15 mg/kg
16323036|NCT00477035|Drug|cyclophosphamide|100 mg/kg
16323037|NCT00477035|Drug|gemcitabine|1250 mg/m2
16323038|NCT00477035|Drug|vinorelbine|30 mg/m2
16323039|NCT00477035|Drug|melphalan|200 mg/m2
16323040|NCT00477022|Device|Vasotrain-447|
16323041|NCT00477009|Device|Mandibular repositioning appliance, adjustable|Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.
16323042|NCT00476996|Drug|Leflunomide|Oral repeating dose
16323043|NCT00476996|Drug|Methotrexate|Oral or parenteral repeating dose
16323044|NCT00476996|Drug|Ocrelizumab|Intravenous repeating dose (200mg)
16323045|NCT00476996|Drug|Ocrelizumab|Intravenous repeating dose (500mg)
16323046|NCT00476996|Drug|Placebo|Intravenous repeating dose
16323047|NCT00476983|Drug|saquinavir/ritonavir plus truvada|SQV/r 1500/100 mg OD + Truvada OD for 2 years
16323048|NCT00476970|Behavioral|Patient Navigation|Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
16323049|NCT00476957|Device|Stent|Stent implantation
16323050|NCT00476957|Device|Stent|Stent implantation
16323051|NCT00476944|Procedure|Percutaneous Coronary Intervention (PCI)|
16323052|NCT00476931|Biological|SB-509|60 mg dose
16323053|NCT00476931|Other|Placebo|Saline
16323054|NCT00476918|Drug|Intravitreal injection (triamcinolone acetonide)|
16323055|NCT00476905|Device|Spectral Diagnosis Probe|The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.
16323056|NCT00476892|Procedure|Pelvic Floor Muscle Training|Women in the intervention group attend 5 physiotherapy sessions. At each appointment a clinical history is taken, pelvic floor muscle assessment carried out, exercises taught and prescribed, and appropriate lifestyle advice given. At the first of these appointments a detailed explanation of the pelvic anatomy and different types of prolapse is given.
16323057|NCT00476879|Drug|Somatropin and pegvisomant|Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
16323058|NCT00476866|Device|intermittent positive-pressure breathing (IPPB)|
16323059|NCT00476853|Drug|HAART containing nevirapine|Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.
16323060|NCT00476827|Drug|Bevacizumab|Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops
16323061|NCT00476827|Drug|Docetaxel|Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops
16323062|NCT00476827|Drug|CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops
16323063|NCT00476827|Drug|Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops
16323064|NCT00476827|Drug|Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops
16323065|NCT00476827|Drug|Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops
16323066|NCT00476801|Device|German manufactured UVA1 light emitting device|The UVA1 dose will be up to 130 J/cm2.
16323067|NCT00476788|Device|Omnipod Insulin Management System|Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
16323068|NCT00476775|Behavioral|after school ethnic dance program - ballet folklorica|
16323069|NCT00476775|Behavioral|culturally-tailored, home-based screen time reduction|
16323070|NCT00476775|Behavioral|culturally-tailored health and nutrition education|
16323071|NCT00476736|Drug|Effect on small airways (N-Acetylcystein)|
16323072|NCT00476710|Drug|Colesevelam HCl|
16323073|NCT00476697|Device|German manufactured UVA1 emitting light system|The dose and scheduling of irradiation is as follows: Up to 130J/cm2 from a UVA1 Sellamed irradiation device with irradiations up to 5 times per week.
16323074|NCT00476684|Procedure|radiofrequency treatment|Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
16323075|NCT00476684|Procedure|sham neurotomy|Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
16323076|NCT00476671|Procedure|lumbar puncture, MRI, MRS|lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia
16323077|NCT00476645|Drug|Fulvestrant|Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly
16323078|NCT00476632|Behavioral|Questionnaire|50 Minute Interview
16323079|NCT00476619|Drug|erythropoeitin|Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
16323080|NCT00476606|Drug|Zidovudine, Stavudine, Didanosine, Lamivudine|Refer to the Thai guideline for HIV management 2007
16323081|NCT00476606|Drug|Nevirapine, Efavirenz|Refer to the Thai guideline for HIV management 2007
16323082|NCT00476606|Drug|LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir|Refer to the Thai guideline for HIV management 2007
16323083|NCT00476593|Drug|Diclofenac|"Preservative- free Diclofenac Na 0.1% eye drops (Voltaren Ophta SDU;Novartis Pharms). One drop four times daily in one eys for three days.
~The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design."
16323084|NCT00476593|Drug|Dexamethasone|"Dexamethasone sodium phosphate 0.1% eye drops (Spersadex OmniVision, Novartis Pharma), one drop six times daily for three days in one eye.
~Pharms). One drop four times daily in one eys for three days.
~The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design."
16323085|NCT00476580|Behavioral|Questionnaire|Questions to collect health information specific to Sri Lankans.
16323086|NCT00476567|Other|standard|standard antenatal care
16323087|NCT00476567|Behavioral|specific training program|a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
16323088|NCT00476554|Drug|Sapacitabine|Sapacitabine
16323089|NCT00476541|Drug|Gemtuzumab ozogamicin|Two courses of Gemtuzumab vs. no further therapy
16323090|NCT00476528|Behavioral|Reality Orientation|Two matched groups of patients diagnosed with TBI are selected from two university hospitals. In addition to conventional treatment, patients in one group are introduced to a reality- orientation programme consisting of systematic orientation, information, and systematic cooperation with the patient´s relatives.Patients in the other group receive conventional treatment only. All patients are tested on a daily basis in accordance with the RLAS and the GOAT test.
16323091|NCT00476528|Behavioral|Reality Orientation|A quasiexperimental study
16323092|NCT00476515|Drug|Rituximab|the recommended dosage of Rituximab is 375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22).
16323093|NCT00476502|Genetic|identify genetic polymorphism in Thai HIV infected|Gene sequencing of Cyp450 metabolic pathway
16323094|NCT00476476|Drug|Erlotinib|Orally every day for about 4-6 weeks
16323095|NCT00476463|Drug|Emtricitabine|Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
16323096|NCT00476437|Drug|biphasic insulin aspart|
16323097|NCT00476437|Drug|biphasic human insulin|
16323098|NCT00476424|Drug|efavirenz|EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days
16323099|NCT00476411|Biological|HBV vaccine|HBV vaccine 3 doses at month 0, 1, and 6
16323100|NCT00476398|Procedure|Capsule endoscopy|Patient will undergo a capsule endoscopy for the evaluation of their chest pain.
16323101|NCT00476385|Drug|somatropine|subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
16323102|NCT00476359|Drug|Lopinavir/r plus saquinavir|lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
16323103|NCT00476346|Dietary Supplement|Calcium & Vitamin D|Calcium 2000mg / daily Vitamin D 800IU / daily
16323104|NCT00476333|Device|APOS biomechanical gait system|
16323105|NCT00476320|Procedure|Magnetic Resonance Imaging|
16323106|NCT00476320|Procedure|Revascularization|
16323107|NCT00476320|Procedure|Echocardiography with myocardial deformation imaging|
16323108|NCT00476307|Biological|Fluarix™/Influsplit SSW® 2007/2008|
16323109|NCT00476294|Other|Telephone Questionnaire|Follow-Up Telephone Calls Every 6 Months for 5 Years.
16323110|NCT00476281|Procedure|Urinary collect|
16323111|NCT00476281|Procedure|Continuous Glucose Monitoring System (CGMS)|
16323112|NCT00476268|Drug|beclomethasone/formoterol (100/6µg) pMDI|Two puffs b.i.d
16323113|NCT00476268|Drug|Beclometasone dipropionate 250 µg/unit dose pMDI|2 inhalations bid
16323114|NCT00476268|Drug|Formoterol powder 12 µg/unit dose|2 inhalations bid
16323115|NCT00476255|Behavioral|Enhanced Standard Care (ESC)|Reading material
16323116|NCT00476255|Behavioral|Brief Motivational Intervention (BMI)|Motivational interview with trained therapist
16323117|NCT00476242|Drug|Vivitrol|intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
16323118|NCT00476242|Drug|memantine|Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.
16323119|NCT00476229|Drug|Thymoglobulin|1.5 mg/kg by vein on Days -11 to -7.
16323120|NCT00476229|Radiation|Total Lymphoid Irradiation|80 cGy daily on days -11 to -7 and -4 to 0.
16323121|NCT00476229|Procedure|Peripheral Blood Stem Cell Infusion|PBSC infusion administered on day 0.
16323122|NCT00476229|Drug|Rituximab|375 mg/m^2 by vein on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.
16323123|NCT00476216|Drug|Combination of Arixtra with chemotherapy|"Single arm, 2 cohort feasibility study:
~Carboplatin will be administered intravenously over approximately 30 minutes after paclitaxel infusion is completed and the dose will be calculated on basis of an area under the curve (AUC) of 6, according to the formula administered every 21 days. Paclitaxel will be administered 200 mg/m2 over 3 hours every 21 days.
~Patients in both cohorts 1 & 2 will receive standard chemotherapy alone during cycle 1.
~Cohort 1:During subsequent cycles (2-4) patients will receive a daily prophylactic dose (day 1 through 21) of Arixtra and continue 21 days after the last course of chemotherapy.
~Cohort 2: Patients in cohort 2 will receive standard chemotherapy alone during cycle 1. During subsequent cycles, the patient will receive a therapeutic weight based dose of Arixtra for the first 2 days of each chemotherapy cycle followed by a daily prophylactic dose of Arixtra (day 3 through 21) until the next course of chemotherapy."
16323124|NCT00476203|Behavioral|Yoga|Instructor-led yoga classes 1/time per week + 4 days of home practice
16323125|NCT00476203|Other|Delayed yoga classes|Delayed yoga classes (after 6 months) offered [wait list control group]
16323126|NCT00476190|Drug|Doxorubicin|Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.
16323127|NCT00476190|Drug|Cytarabine|Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks
16323128|NCT00476190|Drug|Methotrexate|"Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).
~Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks."
16323129|NCT00476190|Drug|Vincristine|Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.
16323130|NCT00476190|Drug|Cyclophosphamide|Consolidation IB: Intravenously on day 1
16323131|NCT00476190|Drug|Methylprednisone|Prophase: Intravenously on days 1-3
16323132|NCT00476190|Drug|Hydrocortisone Sodium Succinate|Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.
16323133|NCT00476190|Drug|Dexamethasone|Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.
16323134|NCT00476190|Drug|6-MP|Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.
16323135|NCT00476190|Drug|PEG-Asparaginase|"Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.
~Consolidation II: Intravenously every 3 weeks."
16323136|NCT00476190|Drug|Imatinib|Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.
16323137|NCT00476190|Drug|Etoposide|Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.
16323138|NCT00476190|Procedure|Radiation Therapy|Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF
16323139|NCT00476190|Drug|E. coli Asparaginase|Intramuscularly Day 7 of Induction.
16323140|NCT00476177|Biological|Infusion of donor dendritic cells|Given in the outpatient setting
16323141|NCT00476177|Biological|Infusion of donor lymphocytes|Given in outpatient setting
16323142|NCT00476164|Drug|Rituximab|2 doses of 1g 14 days apart
16323143|NCT00476164|Other|Control arm|Continue of optimised oral immunosuppression
16323144|NCT00476151|Drug|EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream|topical cream applied daily for 4 weeks
16323145|NCT00476151|Drug|placebo cream|inactive placebo cream applied two times daily
16323146|NCT00476138|Drug|Epigallocatechin-gallate|
16323147|NCT00476125|Behavioral|Dietary manipulation ketogenic diet|Subjects will consume a ketogenic diet for 3 days.
16323148|NCT00476125|Behavioral|Dietary Manipulation - 12 day ketogenic diet|Subjects will consume a ketogenic diet for 12 days.
16323149|NCT00476125|Behavioral|16 Hour Fast|Subjects will fast for 16 hours.
16323150|NCT00476112|Drug|Vernakalant Injection 20 mg/mL|
16323154|NCT00476086|Drug|Gemcitabine|
16323155|NCT00476086|Drug|Oxaliplatin|
16323156|NCT00476086|Radiation|Radiation|
16323157|NCT00476073|Drug|FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)|
16323158|NCT00476060|Procedure|Autologous mesenchymal stem cell transplantation|Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein
16323159|NCT00476047|Combination Product|Tositumomab and Iodine I 131 Tositumomab|Give IV
16323160|NCT00476034|Drug|lumiracoxib|
16323161|NCT00476021|Device|Levonorgestrel-releasing IUD (Mirena)|levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
16323162|NCT00476008|Drug|Memantine|One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
16323163|NCT00476008|Drug|Placebo|One tablet placebo morning and evening (BID) for 12 months
16323164|NCT00475982|Behavioral|Weight Loss|Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
16323165|NCT00475982|Other|No Weight Loss Group|These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
16323168|NCT00475956|Drug|AZD2171|oral tablet multiple ascending doses 20, 30 or 45 mg
16323169|NCT00475956|Drug|AZD0530|oral tablet multiple ascending doses 125 mg or 175 mg
16323170|NCT00475930|Drug|2% chlorhexidine gluconate (CHG) impregnated cloths|self applied three times per week
16323171|NCT00475930|Drug|Comfort Bath cloths (placebo cloths)|self applied three times weekly
16323172|NCT00475917|Drug|XL844|Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.
16323173|NCT00475917|Drug|Gemcitabine|once-weekly 30-minute IV infusion
16323174|NCT00475904|Drug|EpiCept-NP-1 Cream|ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
16323175|NCT00475904|Drug|Gabapentin Capsules|1800mg/day capsules for 4 weeks
16323176|NCT00475904|Drug|placebo|placebo cream and caps
16323177|NCT00475878|Drug|escitalopram|10mg escitalopram/day for 3 months
16323178|NCT00475878|Drug|placebo|placebo capsule/day for 3 months
16323179|NCT00475865|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16323180|NCT00475865|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
16323181|NCT00475865|Drug|Glatiramer Acetate (GA)|Solution in prefilled syringe for subcutaneous injection
16323182|NCT00475852|Drug|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
16323183|NCT00475852|Drug|Placebo|matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
16323184|NCT00475839|Device|Tension-free Vaginal Tape|
16323185|NCT00475839|Device|Monarc sub-fascial hammock|
16323186|NCT00475826|Drug|Statins and Ezetimibe|
16323187|NCT00475813|Drug|FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)|
16323188|NCT00475800|Drug|Lumiracoxib|
16323189|NCT00475787|Procedure|Spinal Manipulation|Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
16323190|NCT00475787|Procedure|Detuned Ultrasound|"US machine is turned on and set at 0 w/cm2"
16323191|NCT00475774|Behavioral|Long-chain (C18:2) and medium chain fatty acid (C8 and C10).|
16323192|NCT00475748|Procedure|Early and late surgery for traumatic central cord syndrome|Surgical decompression of the spinal cord, either front, back or combined
16323193|NCT00475735|Drug|MK0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
16323194|NCT00475735|Drug|Concerta (methylphenidate)|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
16323195|NCT00475735|Drug|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
16323196|NCT00475722|Behavioral|1 Healthy Eating|6 months telephone counseling
16323197|NCT00475722|Behavioral|2 Mediterranean|6 months telephone counseling
16323198|NCT00475709|Device|Trifecta Aortic Heart Valve|Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
16323199|NCT00475696|Drug|Duloxetine|
16323200|NCT00475683|Other|Mouth wash|Mouth wash with chlorehexidin, three times a day
16323201|NCT00475683|Dietary Supplement|Curcumol|5 ml in 50 ml water, mouthwash for 30 seconds, three times a day
16323202|NCT00475670|Drug|Trastuzumab|4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.
16323203|NCT00475670|Drug|Taxane (docetaxel or paclitaxel)|Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.
16323204|NCT00475657|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
16323205|NCT00475657|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles
16323206|NCT00475644|Drug|Enzastaurin|Administered orally
16323207|NCT00475618|Procedure|topical fluoride varnish application.|Vanish application every 6 months in all accesible tooth surfaces
16323208|NCT00475618|Procedure|professional cleaning|Daily use fluoride toothpaste 500 ppm.
16323209|NCT00475618|Procedure|No fluoride toothpaste|Daily use no fluoride toothpaste.
16323210|NCT00475592|Device|Esophageal Capsule Endoscopy|
16323211|NCT00475592|Device|Upper Gastrointestinal Endoscopy|
16323212|NCT00475579|Procedure|tube with subglottic drainage and polyurethane cuff|
16323213|NCT00475566|Device|Dynalink®-E everolimus-eluting peripheral stent|Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
16323214|NCT00475566|Device|Dynalink®-E, everolimus-eluting peripheral stent|Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
16323215|NCT00475553|Other|remove ring if bleeding or spotting occurs more than 5 days|Both groups of women will be using the nuvaring continuously, ie if the ring is placed on 3rd of January, on the 3rd of February the ring would be removed and a new one inserted. On the 3rd of March the same thing would happen and so forth. Group 2 if bleeding or spotting occurs for more than 5 days then on the 6th day the ring is removed and will keep it out for three more days and reinsert the same ring on the 4th day.
16323216|NCT00475553|Other|If bleeding does not remove ring|Subject is using the nuvaring continuously. For example she puts the ring in on 3rd of January then the 3rd of February is when that ring is removed and another one is inserted. The 3rd of March the same thing occurs.
16323217|NCT00475540|Device|synthetic monofilament polypropylene mesh|Vaginal prolapse repair with mesh
16323218|NCT00475527|Drug|omeprazole,clarithromycin,amoxicillin (or metronidazole)|
16323219|NCT00475514|Drug|Frovatriptan 2.5mg QD|
16323220|NCT00475514|Drug|Frovatriptan 2.5 mg BID|
16323221|NCT00475514|Drug|placebo|
16323222|NCT00475501|Drug|Testosterone Enanthate|125 mg, i.m. injection, once/week, for 52 weeks
16323223|NCT00475501|Drug|Finasteride|5 mg, oral, once/day, for 52 weeks
16323224|NCT00475501|Other|Placebo|Placebo
16323225|NCT00475488|Procedure|Coronary artery bypass grafting|Surgery performed due to coronary artery disease.
16323226|NCT00475475|Behavioral|Fructose|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
16323227|NCT00475475|Behavioral|glucose|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
16323228|NCT00475475|Behavioral|non-caloric sweetener|25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
16323229|NCT00475462|Drug|metoprolol|
16323230|NCT00475462|Drug|conventional treatment|
16323231|NCT00475449|Procedure|percutaneous coronary intervention|
16323232|NCT00475449|Procedure|coronary artery bypass grafting|
16323233|NCT00475436|Drug|GSK573719|
16323234|NCT00475423|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16323235|NCT00475410|Drug|ASCs (Cx401, company code)|"Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then.
~Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then."
16323236|NCT00475410|Drug|Fibrin adhesive|Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then.
16323237|NCT00475397|Drug|Duloxetine|
16323238|NCT00475397|Drug|Placebo|
16323239|NCT00475371|Drug|MKC253 Inhalation Powder|Inhalation powder
16323240|NCT00475358|Drug|Duloxetine|
16323241|NCT00475358|Drug|Placebo|
16323242|NCT00475345|Behavioral|Bedtime snacks|
16323243|NCT00475332|Drug|Iodine I -01 Tositumomab (Bexxar)|"Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed dosimetric dose, involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determining the rate of whole body clearance of radioactivity (residence time) so that the administered activity (mCi or GBq) to deliver a 75 cGy (or 65 cGy for patients with baseline platelet count from 100,000 to 149,999/mm^3) total body radiation dose can be calculated."
16323244|NCT00475332|Procedure|External Beam Radiation Therapy|All patients are to receive 20 Gy in 10 fractions of 200 cGy to the PTV
16323245|NCT00475319|Drug|placebo|comparison of different dosages of drug
16323246|NCT00475319|Drug|1% OPC-12759 ophthalmic suspension|comparison of different dosages of drug
16323247|NCT00475319|Drug|2% OPC-12759 ophthalmic suspension|comparison of different dosages of drug
16323248|NCT00475306|Drug|metoclopramide 10 mg|an anti-emetic medication
16323249|NCT00475306|Drug|Diphenhydramine 25 mg|used for prophylaxis against akathisia
16323250|NCT00475306|Drug|Placebo|placebo
16323251|NCT00475306|Drug|Metoclopramide 20 mg|Metoclopramide 20 mg
16323252|NCT00475293|Drug|Panitumumab and CPT-11|"Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg
~Irinotecan: 350 or 300 mg/m2. day 1
~One treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities"
16323253|NCT00475280|Procedure|Geriatric assessment adapted therapy|Geriatric assessment is performed before the induction phase starts.
16323254|NCT00475280|Procedure|Stem cells autotransplantation|Stem cells autotransplantation is performed after consolidation treatment
16323255|NCT00475267|Device|Trifecta aortic heart valve|Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
16323256|NCT00475241|Behavioral|Prolonged Exposure therapy for PTSD|exposure-based treatment for PTSD
16323257|NCT00475241|Behavioral|Present centered therapy for PTSD|present focused coping and problem solving for PTSD
16323258|NCT00475228|Drug|Levonorgestrel IUD|intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
16323259|NCT00475215|Drug|Sugammadex|Sugammadex solution for injection.
16323260|NCT00475215|Drug|Rocuronium|Rocuronium bromide solution for injection.
16323261|NCT00475189|Drug|loestrin 24/4 vs loestrin 1/20|One month of loestrin 1/20 then randomized to Loestrin 24/4 or Loestrin 1/20 x 3 months. After 3 months if randomized to 1/20 will be switched to 24/4 if already on 24/4 will be given a choice which OC they want to continue for 3 more months.
16323262|NCT00475189|Drug|loestrin 1/20|loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE
16323263|NCT00475176|Drug|Peginterferon alfa-2a|
16323264|NCT00475176|Drug|Ribavirin|
16323265|NCT00475176|Drug|S-adenosyl methionine for Chronic Liver Disease|
16323266|NCT00475163|Behavioral|Behavior modification|
16323267|NCT00475150|Drug|cediranib maleate|Given orally
16323268|NCT00475150|Other|laboratory biomarker analysis|Correlative studies
16323269|NCT00475137|Drug|Lamotrigine|Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. For subjects in this combination therapy arm, antidepressant dose will remain constant throughout the study.
16323324|NCT00474734|Device|Intravascular ultrasound of the liver|
16323325|NCT00474721|Drug|ibuprofen|
16323326|NCT00474721|Drug|acetaminophen with codeine|
16323327|NCT00474708|Drug|Effexor|
16323270|NCT00475137|Drug|Lamotrigine|Lamotrigine will be initiated at 25mg daily for two weeks, then increased to 50mg daily for one week, and then increased to 100 mg daily. The dose may then be adjusted upward or downward by 50-100mg weekly, at the investigator's discretion, provided that it remains within the protocol defined range of 100mg - 400mg daily. Subjects in this group will discontinue their antidepressants prescribed to them before the study.
16323271|NCT00475124|Device|Home Monitoring of pacemaker|Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
16323272|NCT00475124|Device|Home Monitoring of pacemaker deactivated|No Home Monitoring data transmission.
16323273|NCT00475111|Behavioral|Cognitive Behavior Therapy for Pain (CBT-P)|
16323274|NCT00475111|Behavioral|Mindfulness Meditation for Emotion Regulation (MM-ER)|
16323275|NCT00475111|Behavioral|Rheumatoid arthritis education|
16323276|NCT00475098|Drug|Tinzaparin sodium 100 UI/Kg/OD for 12 weeks|treatment in lung tumours
16323277|NCT00475085|Drug|aprepitant|Given orally or IV
16323278|NCT00475085|Drug|dexamethasone|Given orally or IV
16323279|NCT00475085|Drug|granisetron hydrochloride|Given orally or IV
16323280|NCT00475085|Drug|palonosetron hydrochloride|Given orally or IV
16323281|NCT00475085|Drug|prochlorperazine|Given orally or IV
16323282|NCT00475085|Drug|placebo|Given orally
16323283|NCT00475072|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
16323284|NCT00475072|Drug|ribavirin|1000/1200mg po daily for 48 weeks
16323285|NCT00475059|Drug|cimetidine arrow|patients who received cimétidine
16323286|NCT00475046|Behavioral|Motivational Interviewing|
16323287|NCT00475033|Biological|13-valent Pneumococcal Conjugate Vaccine|13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
16323288|NCT00475033|Biological|7-valent pneumococcal conjugate vaccine|7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
16323289|NCT00475020|Drug|Busulfan|Test dose = 32 mg/m^2 by vein x 1 day; 100 mg/m^2 by vein daily over 3 hours x 4 days
16323290|NCT00475020|Drug|Fludarabine|40 mg/m^2 by vein daily over 1 hour x 4 days
16323291|NCT00475020|Drug|Thymoglobulin (ATG)|2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor
16323292|NCT00475007|Device|IBV® Valve System|The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
16323293|NCT00474994|Drug|sunitinib malate|
16323294|NCT00474981|Behavioral|IMNCI|Implementation of IMNCI in the intervention sites
16323295|NCT00474968|Device|e2 Cell Collector [SoftPAP(R)]|Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]
16323296|NCT00474968|Device|Spatula/Brush|Cervical cells collected using a combination of a cervical spatula and an endocervical brush
16323297|NCT00474955|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms or 135 micrograms sc weekly for 48 weeks
16323298|NCT00474929|Drug|RAD001|Phase I: Dose level 0: RAD001 5mg every other day; Dose level 1: RAD001 5mg every day; Dose level 2: RAD001 5mg every day; Dose level 3: RAD001 10mg every day; Phase II: RAD001 5mg every day;
16323299|NCT00474929|Drug|Sorafenib|Phase I: Dose level 0: Sorafenib 200 mg twice daily; Dose level 1: Sorafenib 200 mg twice daily; Dose level 2: Sorafenib 400 mg twice daily; Dose level 3: Sorafenib 400 mg twice daily; Phase II: Sorafenib 200 mg twice daily;
16323300|NCT00474916|Drug|KRN5500|Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
16323301|NCT00474916|Drug|Placebo|Normal Saline given as dose escalation for placebo
16323302|NCT00474903|Drug|acetylsalicylic acid|Given orally
16323303|NCT00474903|Drug|esomeprazole magnesium|Given orally
16323304|NCT00474903|Other|placebo|Given orally
16323305|NCT00474890|Drug|cetericine and pseudoephedrine|
16323306|NCT00474877|Device|Static resting splints|
16323307|NCT00474864|Drug|GW856553|
16323308|NCT00474851|Drug|Norethindrone acetate + estrogens|Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily
16323309|NCT00474851|Drug|norethindrone acetate + placebo|norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily
16323310|NCT00474838|Drug|intensive insulin group|Once daily long acting insulin and preprandial rapid acting insulin injection
16323311|NCT00474838|Drug|Oral AntiDiabetic Drug (glimepiride and metformin)|glimepiride and metformin combined therapy
16323312|NCT00474825|Drug|Hyperbaric Oxygen Therapy|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
16323313|NCT00474825|Drug|Hyperbaric Oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
16323314|NCT00474825|Drug|Hyperbaric oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
16323315|NCT00474825|Drug|Hyperbaric oxygen|Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
16323316|NCT00474812|Drug|dasatinib|
16323317|NCT00474812|Procedure|laboratory biomarker analysis|Correlative study
16323318|NCT00474812|Procedure|physiologic testing|Correlative study
16323319|NCT00474799|Drug|MNS075|MNS075 7.5mg q1h MNS075 15mg q3h
16323320|NCT00474786|Drug|Sorafenib|Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
16323321|NCT00474786|Drug|temsirolimus (Torisel)|Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
16323322|NCT00474773|Drug|Celecoxib|
16323323|NCT00474760|Drug|CP-751,871|Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
16323329|NCT00474695|Drug|Lucentis|0.05 mg intravitreal injection
16323330|NCT00474682|Drug|Micronized dispersible ferric pyrophosphate|
16323331|NCT00474669|Drug|docetaxel|Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol
16323332|NCT00474656|Device|High-frequency oscillation|
16323333|NCT00474656|Device|Conventional lung-open mechanical ventilation|
16323334|NCT00474630|Drug|Naltrexone SR 32 mg/bupropion SR 360 mg/ day|
16323335|NCT00474630|Drug|Placebo|
16323336|NCT00474630|Behavioral|Ancillary therapy|Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
16323337|NCT00474617|Drug|Sugammadex|
16323338|NCT00474617|Drug|Rocurium|intravenous (IV) single bolus dose of 0.6 mg.kg-1
16323339|NCT00474604|Procedure|diffusion-weighted magnetic resonance imaging|A scan will be performed.
16323340|NCT00474604|Procedure|dynamic contrast-enhanced magnetic resonance imaging|A scan will be performed.
16323341|NCT00474604|Procedure|magnetic resonance spectroscopic imaging|A scan will be performed.
16323342|NCT00474591|Drug|Fondaparinux|
16323343|NCT00474565|Procedure|Placement of an aortic root pigtail catheter.|Seldinger technique for placement of catheter.
16323344|NCT00474552|Drug|SAM-315|Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;
16323345|NCT00474539|Biological|13-valent pneumococcal conjugate vaccine|1 dose at 2,4,6 and 15 months of age
16323346|NCT00474539|Biological|7-valent pneumococcal conjugate vaccine|1 dose at 2,4,6 and 15 months of age
16323347|NCT00474526|Biological|Meningococcal ACWY Conjugate Vaccine|
16323348|NCT00474526|Biological|DTaP-IPV-HBV|
16323349|NCT00474526|Biological|Hib|
16323350|NCT00474526|Biological|Rotavirus|
16323351|NCT00474526|Biological|Pneumococcal 7-valent Conjugate Vaccine|
16323352|NCT00474526|Biological|HAV|
16323353|NCT00474526|Biological|MMR-V|
16323354|NCT00474526|Biological|DTaP|
16323355|NCT00474513|Drug|GSK239512|
16323356|NCT00474500|Drug|Coca, Cola, Diet Coke|
16323357|NCT00474487|Biological|Meningococcal ACWY Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
16323358|NCT00474487|Biological|MenACWY CRM (19 to 55 years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
16323359|NCT00474487|Biological|Meningococcal ACWY Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
16323360|NCT00474487|Biological|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
16323361|NCT00474474|Procedure|Virtual patient is NOT introduced|
16323362|NCT00474461|Biological|Treatment group|Intracoronary injection of cardiac stem cells
16323363|NCT00474435|Drug|Emtricitabine/tenofovir/efavirenz|"Co-formulated in one tablet (taken once daily by oral administration):
~emtricitabine 200 mg
~tenofovir DF 300 mg
~efavirenz 600 mg"
16323364|NCT00474422|Behavioral|Proactive assignment to attend a breastfeeding clinic|
16323365|NCT00474409|Drug|Merislon|
16323366|NCT00474396|Behavioral|Low fat dairy diet|
16323367|NCT00474383|Drug|Abiraterone acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.
16323368|NCT00474383|Drug|Glucocorticoid|Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.
16323369|NCT00474370|Drug|Vicriviroc|One tablet of vicriviroc 30 mg once daily.
16323370|NCT00474370|Drug|Placebo|One tablet of placebo once daily.
16323371|NCT00474357|Behavioral|Brief Structured Psychoeducation Group Therapy|weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
16323372|NCT00474305|Behavioral|Virtual Reality Treatment for PTSD|12 session protocol for Prolonged Exposure with Virtual Reality. All sessions 90 minutes.
16323373|NCT00474279|Drug|Orally active growth hormone secretagogue (MK-677)|
16323374|NCT00474266|Biological|Meningococcal vaccine GSK134612 (Nimenrix)|Single dose intramuscular injection
16323375|NCT00474266|Biological|Priorix-Tetra|2-dose subcutaneous injection
16323376|NCT00474266|Biological|Meningitec|Single dose intramuscular injection
16323377|NCT00474253|Drug|Sugammadex|Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex
16323378|NCT00474253|Drug|Succinylcholine|Single bolus IV dose of 1.0 mg/kg succinylcholine
16323379|NCT00474253|Drug|Rocuronium|Single bolus IV dose of 1.2 mg/kg rocuronium
16323380|NCT00474240|Drug|Atorvastatin 20 mg|
16323381|NCT00474240|Drug|AEGR-733 5 mg|
16323382|NCT00474240|Drug|AEGR-733 10 mg|
16323383|NCT00474240|Drug|Placebo|
16323384|NCT00474240|Drug|AEGR-733 5 mg + atorvastatin 20 mg|
16323385|NCT00474240|Drug|AEGR-733 10 mg + atorvastatin 20 mg|
16323386|NCT00474227|Behavioral|group therapy, physical exercise, nutrition lectures|weekly group therapy, physical exercize, nutrition guidance
16323387|NCT00474214|Behavioral|Early hospital discharge facilitated by close nurse practitioner follow-up|
16323388|NCT00474201|Drug|Lopinavir/Ritonavir|lopinavir 400 mg + ritonavir 100 mg twice daily for 2 weeks
16323389|NCT00474201|Drug|Gemfibrozil|Control arm (no intervention used in this arm)
16323390|NCT00474188|Drug|CC-5013 (lenalidomide)|Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
16323391|NCT00474188|Drug|dexamethasone|Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
16323392|NCT00474175|Drug|Placebo gel|single dose (less than 1g) of a matching placebo gel
16323393|NCT00474175|Drug|benzocaine|single dose (less than 1g) of 10% benzocaine gel formulation
16323394|NCT00474175|Drug|benzocaine|single dose (less than 1g) of 20% benzocaine gel formulation
16323395|NCT00474162|Drug|Pentaspan®|15 ml/kg of starch solution, approximately 1 litre
16323396|NCT00474162|Drug|Normal Saline|15 ml/kg of either saline solution, approximately 1 litre
16323397|NCT00474136|Drug|Intravenous diclofenac sodium (DIC075V) 18.75 mg|DIC075V 18.75 mg
16323398|NCT00474136|Drug|Intravenous diclofenac sodium (DIC075V) 37.5 mg|DIC075V 37.5 mg
16323399|NCT00474136|Drug|Oral diclofenac potassium 50 mg|Oral diclofenac potassium 50 mg
16323400|NCT00474123|Drug|Simvastatin 80 mg/day for 6 weeks|Simvastatin 80 mg/day, single dose, for 6 weeks.
16323401|NCT00474123|Drug|Ezetimibe 10 mg / Simvastatin 20 mg|"Ezetimibe 10 mg / Simvastatin 20 mg
~Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks"
16323402|NCT00474110|Drug|Ketamine & hydromorphone|See Detailed Description
16323403|NCT00474084|Device|Intravascular Coronary Stent|
16323404|NCT00474071|Drug|Remifentanil|See Detailed Description.
16323405|NCT00474058|Drug|Rotigotine|"Rotigotine transdermal patches:
~10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
~Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h"
16323406|NCT00474058|Other|Placebo|Placebo transdermal patches
16323407|NCT00474045|Drug|insulin detemir|Treat-to-target, dose titration, s.c. (under the skin) injection
16323408|NCT00474045|Drug|NPH insulin|Treat-to-target, dose titration, s.c. (under the skin) injection
16323409|NCT00474045|Drug|insulin aspart|Treat-to-target, dose titration, s.c. (under the skin) injection
16323410|NCT00474032|Drug|Botulinum Toxin (Type A) injection (10 U/Kg)|See Detailed Description.
16323411|NCT00474019|Drug|esomeprazole|IV qd for 4 days
16323412|NCT00474006|Drug|arm II|Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days
16323413|NCT00473980|Drug|Indomethacin, celecoxib, esomeprazole|
16323414|NCT00473967|Biological|Na-ASP-2 Hookworm Vaccine|Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.
16323415|NCT00473954|Genetic|EGEN-001 (phIL-12-005/PPC)|"In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart.
~Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals."
16323416|NCT00473941|Behavioral|Expressive writing|Quality of life measures through writing
16323417|NCT00473928|Drug|POT-4|Single intravitreal injection.
16323418|NCT00473915|Drug|fluticasone furoate|corticosteroid nasal spray
16323419|NCT00473902|Behavioral|Training|
16323420|NCT00473902|Drug|Creatine Monohydrate, Conjugated Linoleic Acid|
16323421|NCT00473889|Drug|vorinostat|vorinostat 400 mg capsules once daily. Up to 6 months of treatment
16323422|NCT00473889|Drug|Comparator: paclitaxel|intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
16323423|NCT00473889|Drug|Comparator: carboplatin|intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
16323424|NCT00473889|Drug|Comparator: placebo|vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment
16323425|NCT00473876|Drug|Metformin|Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks
16323426|NCT00473876|Drug|Matched Placebo (Capsules)|Similar dosing regime as active comparator
16323427|NCT00473863|Procedure|Coronary Computed Tomographic Angiography|CCTA will be performed
16323428|NCT00473837|Drug|Chloroquine|This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days
16323429|NCT00473837|Drug|Placebo|The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul
16323430|NCT00473824|Biological|Hepatitis C Immune Globulin Intravenous (Human) 5%|Hepatitis C Immune Globulin Intravenous (Human) 5%, [Civacir]: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight given with standard post-transplant therapy inclusive of immunosuppressive agents.
16323431|NCT00473811|Behavioral|Low GI|low-GI education
16323432|NCT00473811|Behavioral|ADA diet|ADA dietary education
16323433|NCT00473798|Behavioral|Questionnaire|Questionnaire
16323434|NCT00473785|Behavioral|Group-based motivational interviewing|
16323435|NCT00473785|Behavioral|Individual CVD-risk factor feedback|
16323436|NCT00473785|Behavioral|Education for protective health behavior change|
16323437|NCT00473772|Device|DEBlue stent vs. Cypher stent|DES vs. DEB with BMS
16323438|NCT00473746|Drug|Abiraterone acetate|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established.
16323439|NCT00473746|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg daily under fasted conditions upto 10 cycles of therapy.
16323440|NCT00473746|Drug|prednisone/prednisolone or dexamethasone|prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate
16323441|NCT00473733|Procedure|GLP receptors expression|
16323442|NCT00473733|Procedure|ESOPHAGOGASTRODUODENOSCOPY|
16323443|NCT00473720|Drug|Satraplatin|Dose escalation of 40, 60 and 80 mg/m²/day on days 1-5
16323444|NCT00473720|Drug|Abraxane|Dose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days
16323506|NCT00473317|Behavioral|Sun Exposure|Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).
16323445|NCT00473707|Procedure|Active management of the third stage of labor|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
16323446|NCT00473707|Procedure|Expectant management of the third stage of labor|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
16323447|NCT00473707|Drug|Oxytocin and gentle cord traction with fundal massage|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
16323448|NCT00473707|Drug|Oxytocin|standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
16323449|NCT00473694|Drug|sugammadex|Administered as an intravenous (IV) infusion
16323450|NCT00473694|Drug|neostigmine|Administered as an IV infusion
16323451|NCT00473694|Drug|vecuronium|Administered as an IV infusion
16323452|NCT00473694|Drug|rocuronium|Administered as an IV infusion
16323453|NCT00473694|Drug|glycopyrrolate|Administered as an IV infusion
16323454|NCT00473681|Behavioral|Self-Help Intervention Program-High Blood Pressure|
16323455|NCT00473668|Biological|Zilbrix-Hib|Intramuscular injection, 1 dose
16323456|NCT00473668|Biological|Tritanrix™-HepB/ Hiberix™|Intramuscular injection, 1 dose
16323457|NCT00473655|Drug|rosuvastatin|10mg or 20mg
16323458|NCT00473642|Drug|Ranibizumab|intravitreal administered ranibizumab 0.5 mg in 0.05 mL
16323459|NCT00473642|Drug|Verteporfin|Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
16323460|NCT00473642|Drug|Verteporfin|Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
16323461|NCT00473616|Drug|AZD7762|intravenous infusion
16323462|NCT00473616|Drug|Irinotecan|intravenous injection
16323463|NCT00473603|Drug|lipid/heparin infusion|to perform an i.v. lipid heparin infusion infusion for 4 h
16323464|NCT00473590|Drug|Bevacizumab|15 mg/kg administered by intravenous infusion
16323465|NCT00473590|Drug|Bortezomib|1.3 mg/m^2 administered by intravenous bolus injection
16323466|NCT00473590|Drug|placebo|Intravenous repeating dose
16323467|NCT00473577|Drug|CRA-24781|
16323468|NCT00473564|Procedure|da Vinci® Robotic System|Head and Neck Surgery using the da Vinci® Robotic System
16323469|NCT00473551|Drug|Rituximab|375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8.
16323470|NCT00473551|Drug|Cyclophosphamide|50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine.
16323471|NCT00473551|Drug|Fludarabine|40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6.
16323472|NCT00473551|Drug|Mesna|10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide.
16323473|NCT00473551|Radiation|Radiation Treatment|2Gy Total body radiation day before transplantation
16323474|NCT00473551|Procedure|Stem Cell Transplantation (SCT)|Allo CD34+ Selected SCT/Infusion of stem cells.
16323475|NCT00473551|Drug|Sirolimus|6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7.
16323476|NCT00473551|Procedure|Anti-third Party Cytolytic T-lymphocytes (CTL)|Intravenous infusion of anti-third party CTL.
16323477|NCT00473538|Behavioral|Structured exercise training|
16323478|NCT00473538|Behavioral|Hypocaloric hyperproteic diet|
16323479|NCT00473525|Drug|Placebo|Placebo QD
16323480|NCT00473525|Drug|PF-00734200 10 mg QD|10 mg QD
16323481|NCT00473525|Drug|PF-00734200 20 mg QD|20 mg QD
16323482|NCT00473525|Drug|PF-00734200 5 mg QD|5 mg QD
16323483|NCT00473525|Drug|PF-00734200 2 mg QD|2 mg QD
16323484|NCT00473512|Drug|Abiraterone acetate|Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.
16323485|NCT00473512|Drug|Abiraterone acetate MTD|Abiraterone acetate MTD orally for 12 cycles (28 day each).
16323486|NCT00473512|Drug|Dexamethasone|Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.
16323487|NCT00473499|Device|DEBlue vs Cypher vs BMS|BMS vs DES vs DEB+BMS
16323488|NCT00473486|Drug|pemetrexed, carboplatin, sorafenib|"Ph. 1: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; Sorafenib 200mg po bid days 2-19; 400mg po bid days 2-19
~Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1;sorafenib depending on results of Ph 1"
16323489|NCT00473486|Drug|pemetrexed, carboplatin, placebo|Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; placebo day 2-19
16323490|NCT00473473|Drug|Potassium Dichromate (Homeopathy)|twice daily with an interval of 12 hours, for a period of up to 14 days
16323491|NCT00473473|Drug|Placebo homeopathic remedy|identical to treatment without active component
16323492|NCT00473460|Drug|Avelox (Moxifloxacin, BAY12-8039)|Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
16323493|NCT00473460|Drug|Placebo|Matching placebo capsules orally once daily for 5 days every 8 weeks.
16323494|NCT00473447|Behavioral|Modified Constraint-induced movement therapy|
16323495|NCT00473434|Drug|Paliperidone|3mg or 6mg or 9mg or 12mg once daily for 52 weeks
16323496|NCT00473421|Procedure|Barium Sulphate and Zirconium Oxide|
16323497|NCT00473408|Device|Functional MRI (DCE-MRI)|MRI examination with i.v. gadolinium contrast to assess blood perfusion in remaining tumor tissue.
16323498|NCT00473408|Procedure|Blood sample|See protocol.
16323499|NCT00473408|Procedure|Tumor sample|See protocol.
16323500|NCT00473382|Drug|Ranibizumab|Sterile solution for intravitreal injection.
16323501|NCT00473382|Drug|Sham injection|
16323502|NCT00473356|Dietary Supplement|receive amino acid supplement|Receive amino acid supplement
16323503|NCT00473343|Procedure|Photodynamic therapy with Metvix 160 mg/g cream|
16323504|NCT00473330|Drug|Ranibizumab|Sterile solution for intravitreal injection.
16323505|NCT00473330|Drug|Sham injection|
16323507|NCT00473304|Device|Johnson&Johnson Acuevue daily disposable lenses|
16323508|NCT00473265|Drug|PTH|
16323509|NCT00473239|Drug|cholecalciferol.|100,000 IU of Vitamin D
16323510|NCT00473213|Drug|Interferon Beta 1|
16323511|NCT00473200|Dietary Supplement|S-adenosylmethionine|1200 mg daily
16323512|NCT00473187|Drug|somatropin|
16323513|NCT00473174|Drug|Ramipril|Dosing on awakening versus bedtime
16323514|NCT00473174|Device|ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
16323515|NCT00473161|Device|surface EMG biofeedback|
16323516|NCT00473148|Procedure|BNP-guided weaning|BNP-guided weaning
16323517|NCT00473148|Procedure|Standard physician-directed weaning|Standard physician-directed weaning
16323518|NCT00473135|Biological|rDEN1delta30|Live attenuated rDEN1delta30 vaccine at a dose of 10^3 PFU
16323519|NCT00473135|Biological|Placebo|Placebo for rDEN1delta30
16323520|NCT00473122|Procedure|Delayed-Immediate Breast Reconstruction|Immediate reconstruction surgery if no XRT required; or reconstruction surgery delayed until XRT complete.
16323521|NCT00473109|Procedure|Dialysis without systemic heparinization|Dialysis without systemic heparinization
16323522|NCT00473096|Behavioral|Informed breast cancer surgical treatment|
16323523|NCT00473083|Drug|Minocycline|Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
16323524|NCT00473083|Drug|Clindamycin 2% in hydrocortisone 1% lotion|"Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture.
~If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles."
16323525|NCT00473083|Drug|Erlotinib|Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.
16323526|NCT00473083|Drug|Topical clindamycin 2%, triamcinolone acetonide 0.1% soln|Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water
16323527|NCT00473070|Drug|Tobradex AF|
16323528|NCT00473057|Other|Autologous cell transplantation|Intra-arterial or intravenous delivery of autologous bone marrow cells
16323529|NCT00473044|Behavioral|Sisters in Motion|
16323530|NCT00473031|Behavioral|Caloric restriction, high protein|Weight loss with higher protein (35%) intake
16323531|NCT00473031|Behavioral|Caloric restriction; normal protein|Weight loss with recommended level of protein (18%)intake
16323532|NCT00473031|Behavioral|Counseling|Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
16323533|NCT00473018|Behavioral|standard versus enhanced risk reduction counseling|
16323534|NCT00473005|Drug|Capecitabine|825 mg/m2 bid, Oral
16323535|NCT00473005|Drug|RAD001|2.5mg QOD, 2.5mg QD, 5.0mg QD, Oral
16323536|NCT00472966|Drug|Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels|Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10
16323537|NCT00472953|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
16323538|NCT00472953|Drug|insulin aspart|Treat-to-target dose titration scheme, pre-prandial, injection s.c.
16323539|NCT00472927|Drug|Premarin/MPA 0.45 mg/1.5 mg|
16323540|NCT00472914|Device|portable surface electromyography|
16323541|NCT00472901|Drug|Afamelanotide (CUV1647)|16mg implant
16323542|NCT00472875|Drug|Glibenclamide|
16323543|NCT00472862|Behavioral|Cognitive training|Cognitive training for 16 weeks integrated in OPUS psychosocial treatment
16323544|NCT00472849|Drug|Oxaliplatin|Oxaliplatin 30 mg/m^2/day, over approximately 2 hours, before fludarabine is started, on days 1-4.
16323545|NCT00472849|Drug|Fludarabine|Fludarabine 30 mg/m^2 daily IV, over approximately 30 minutes, on days 2-3, 2-4, or 2-5 until maximum tolerated dose is reached.
16323546|NCT00472849|Drug|Cytarabine|Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose is started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose is reached.
16323547|NCT00472849|Drug|Rituximab|Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
16323548|NCT00472849|Drug|Pegfilgrastim|6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy
16323549|NCT00472836|Drug|CP-945,598|Administration of CP-945,598 in subjects with normal renal function.
16323550|NCT00472836|Drug|CP-945,598|Administration of CP-945,598 in subjects with severe renal impairment.
16323551|NCT00472823|Dietary Supplement|Vitamin D3|Orally for one year
16323552|NCT00472823|Dietary Supplement|Calcium Citrate (Citracal)|Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
16323553|NCT00472810|Device|ologen collagen matrix in glaucoma filtering surgery|If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
16323554|NCT00472810|Drug|MMC in glaucoma filtering surgery|If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
16323555|NCT00472797|Drug|Rebif New Formulation Non Titrated|human interferon beta 1a - Rebif New Formulation
16323556|NCT00472797|Drug|Rebif New Formulation Titrated|Human interferon beta 1a Rebif New Formulation
16323557|NCT00472771|Drug|INNO-206|
16323558|NCT00472758|Biological|MEDI 545|IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
16323559|NCT00472758|Other|Placebo|IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
16323560|NCT00472745|Behavioral|Weight Loss|Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months
16323561|NCT00472745|Behavioral|Weight Maintenance|Diet for weight maintenance for 6 months
16323562|NCT00472719|Biological|VRC-HIVADV027-00-VP|Adenoviral vector booster vaccine
16323563|NCT00472719|Biological|VRC-HIVADV038-00-VP|Adenovirus vector booster vaccine
16323564|NCT00472719|Biological|VRC-HIVDNA044-00-VP|Experimental, multiclade, multigene HIV DNA vaccine
16323565|NCT00472706|Procedure|excision|excision 3 mm margin
16323566|NCT00472706|Procedure|Photodynamic therapy|Photodynamic therapy
16323567|NCT00472693|Drug|Bevacizumab, Abraxane|Bevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities.
16323568|NCT00472680|Behavioral|Caloric restriction, high protein|Weight loss with higher protein (35%) intake
16323569|NCT00472680|Behavioral|Caloric restriction; normal protein|Weight loss with normal level of protein (18%) intake
16323570|NCT00472680|Behavioral|Nutrition Education|Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month
16323571|NCT00472667|Procedure|Procalcitonin guided strategy|Procalcitonin guided strategy
16323572|NCT00472654|Behavioral|Weight Loss|Diet for weight loss for 6 weeks; all weight loss participants will attend 6 weekly counseling sessions (about 50 minutes per session)
16323573|NCT00472654|Dietary Supplement|Vitamin D 2500 IU|Daily Vitamin D 2500 IU supplement for 6 weeks
16323574|NCT00472654|Behavioral|Weight Maintenance|Diet for weight maintenance for 6 weeks
16323575|NCT00472641|Drug|Ziprasidone/Geodon|Ziprasidone/Geodon
16323576|NCT00472628|Procedure|Blood samples collected|
16323577|NCT00472576|Drug|MK-0657|Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day)
16323578|NCT00472576|Drug|Placebo|Daily double-blind administration of placebo
16323579|NCT00472563|Drug|Bicarbinate 150 mEq/L|75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
16323580|NCT00472550|Drug|esomeprazole 20 mg|
16323581|NCT00472537|Procedure|Retromuscular Mesh repair of midline incisional hernia|
16323582|NCT00472537|Procedure|Laparoscopic repair of midline incisional hernia|
16323583|NCT00472524|Procedure|Mydriasis/cycloplegia via different modes of administration|
16323584|NCT00472485|Procedure|eye movement therapy|
16323585|NCT00472472|Device|paclitaxel coated balloon catheter (device with drug)|PTA vs Paccocath
16323586|NCT00472459|Procedure|Photodynamic therapy with Metvix 160 mg/g cream|
16323587|NCT00472446|Drug|bilateral superficial cervical block|10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.
16323588|NCT00472446|Drug|placebo bilateral superficial cervical block|"10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.
~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
16323589|NCT00472433|Drug|Alemtuzumab|
16323590|NCT00472420|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv every 3 weeks
16323591|NCT00472420|Drug|First line chemotherapy|As prescribed
16323592|NCT00472381|Drug|Insulin|Insulin
16323593|NCT00472368|Drug|LBH589|
16323594|NCT00472355|Drug|apomorphine|
16323595|NCT00472342|Behavioral|exercise prescription|
16323596|NCT00472329|Procedure|Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors|
16323597|NCT00472329|Drug|fludarabine|
16323598|NCT00472329|Procedure|TBI|
16323599|NCT00472316|Behavioral|Active Case Finding for Tuberculosis|Active case finding of TB in the community using community health workers
16323600|NCT00472303|Drug|Tapentadol Extended Release|Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg.
16323601|NCT00472303|Drug|Matching Placebo after Tapentadol in the Titration Phase.|Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. In the maintenance phase only to participants that were randomized to tapentadol in the titration phase.
16323602|NCT00472303|Drug|Morphine Sulphate Controlled Release|Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 40 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
16323603|NCT00472290|Drug|Romiplostim (formerly AMG 531)|"Subjects will begin the study at an initial dose of 750 µg.
~Except for:
~Subject whose doses were escalated to doses higher than 750 µg AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.
~Subjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count."
16323604|NCT00472264|Procedure|PET imaging|Medical imaging assessment
16323605|NCT00472238|Behavioral|endurance training|control group.
16323606|NCT00472238|Behavioral|exercise training|Treadmill exercise training to optimize physical endurance
16323607|NCT00472225|Drug|Rituximab|"Rituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks
~Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months"
16323608|NCT00472212|Device|Spectacles|Hyperopic spectacle lenses
16323609|NCT00472212|Device|Control|Plano (no power, control) spectacle lenses
16323610|NCT00472199|Drug|Pramipexole|
16323611|NCT00472199|Drug|Placebo|
16323656|NCT00471796|Behavioral|Biofeedback|
16323838|NCT00470353|Dietary Supplement|calcium carbonate|
16323612|NCT00472186|Drug|Lansoprazole|If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.
16323613|NCT00472186|Drug|Placebo|Placebo will also be administered based on weight.
16323614|NCT00472173|Drug|Mineral Trioxide Aggregate|Apexification treatment of the tooth with Mineral Trioxide Aggregate
16323615|NCT00472173|Drug|Calcium hydroxide|Apexification treatment of the tooth with Calcium hydroxide
16323616|NCT00472160|Procedure|Non Invasive Ventilation|Non Invasive Ventilation
16323617|NCT00472147|Procedure|shock efficacy|
16323618|NCT00472134|Drug|bupivacaine|administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.
16323619|NCT00472134|Device|On-Q PainBuster pump|local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days
16323620|NCT00472121|Device|TOF-Watch SX (neuromuscular monitor)|The variation between arms (dominant or non-dominant) when monitored with the same method on both arms
16323621|NCT00472108|Procedure|PDT with Metvix 160 mg/g cream|
16323622|NCT00472108|Procedure|PDT with placebo cream|
16323623|NCT00472095|Other|Fotonovela|
16323624|NCT00472095|Other|Placebo Fotonovela|
16323625|NCT00472082|Drug|efalizumab|Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study.
16323626|NCT00472069|Procedure|transplantation of the squeletic muscular cells|transplantation of the squeletic muscular cells
16323627|NCT00472056|Drug|Carmustine|300 mg/m^2 IV for 1 Day
16323628|NCT00472056|Drug|Etoposide|Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
16323629|NCT00472056|Drug|Cytarabine|Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days
16323630|NCT00472056|Drug|Melphalan|140 mg/m^2 IV x 1 Day
16323631|NCT00472056|Drug|Rituximab|Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.
16323632|NCT00472043|Procedure|PDT with Metvix 160 mg/g cream and Placebo cream|
16323633|NCT00472030|Drug|Omalizumab|Patients will be treated with 150-375 milligrams of Omalizumab (Xolair), based on their baseline weight and serum Immunoglobulin E levels. Omalizumab will be administered subcutaneously on Day 1, and on Week 2, 4, 6, 8, 10, 12 and 14 treatment.
16323634|NCT00472030|Drug|prednisone|Prednisone, to a maximum dose of 0.5 mg/kg/day.
16323635|NCT00472017|Drug|vandetanib|Oral vandetanib administration will start on the same day as RT. Treatment with vandetanib will extend for the entire duration of RT, and then will be continued after completion of RT for a maximum duration of 2 years.
16323636|NCT00472004|Drug|17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)|17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
16323637|NCT00472004|Drug|Tibolone (Livial)|Tibolone 2.5 mg 1 daily, 1 year duration
16323638|NCT00471991|Drug|SH T04769G|The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.
16323639|NCT00471991|Drug|Ethinyl estradiol / dienogest (SH D00659 AF)|The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.Volunteers have to undergo a series of blood sampling during the 2nd treatment cycle to evaluate the pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the new oral contraceptive.
16323640|NCT00471965|Drug|Oxaliplatin + 5-Fluorouracil/Leucovorin|"Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.
~Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.
~Repeated every 2 weeks"
16323641|NCT00471965|Drug|Doxorubicin|Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
16323642|NCT00471952|Drug|Maxalt 10mg MLT plus Caffeine 75mg|One migraine attack will be treated
16323643|NCT00471952|Drug|Maxalt 10mg MLT plus Placebo|One migraine attack will be treated with Maxalt 10mg plus placebo
16323644|NCT00471952|Drug|Placebo + Placebo|One migraine attack will be treated with double placebo
16323645|NCT00471939|Drug|I-020502|1 mcg/mL TG-PDGF.AB
16323646|NCT00471913|Device|Femoral Nailing with Different Entry Points|See Detailed Description.
16323647|NCT00471900|Drug|dehydroepiandrosterone (DHEA)|
16323648|NCT00471887|Biological|CP-675,206|Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity.
16323650|NCT00471835|Procedure|computed tomography|
16323651|NCT00471835|Procedure|positron emission tomography|
16323652|NCT00471835|Radiation|stereotactic body radiation therapy|
16323653|NCT00471809|Drug|Budesonide + Salmeterol + Azithromycin|
16323654|NCT00471809|Drug|Budesonide + Salmeterol + Montelukast|
16323655|NCT00471809|Drug|Budesonide + Salmeterol + Placebo|
16323657|NCT00471783|Procedure|Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.|
16323658|NCT00471744|Drug|Treatment with levetiracetam or sulthiame over a six-month period.|
16323659|NCT00471718|Drug|ABT-751|"Phase I:
~Cohort | Number of Patients |Dose (mg) ABT-751 (BID)
~-1 | 3-6 |100 mg BID
~1 | 3-6 |125 mg BID
~2 | 3-6 |150 mg BID
~3 | 3-6 |175 mg BID
~4 | 3-6 |200 mg BID
~Phase II:
~Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle"
16323660|NCT00471705|Drug|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
16323661|NCT00471705|Device|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
16323662|NCT00471705|Drug|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
16323663|NCT00471692|Drug|Ropivicaine|
16323664|NCT00471679|Drug|ethanol|
16323665|NCT00471653|Drug|temozolomide|
16323666|NCT00471653|Genetic|comparative genomic hybridization|
16323667|NCT00471653|Genetic|polymorphism analysis|
16323668|NCT00471653|Other|laboratory biomarker analysis|
16323669|NCT00471653|Other|pharmacological study|
16323670|NCT00471653|Radiation|radiation therapy|
16323671|NCT00471640|Drug|dexamethasone|4 days 5 mg
16323672|NCT00471627|Procedure|Pancreaticojejunostomy without stiches through the pancreas|The pancreas is cut with knife, without electric cautery and without stay sutures. Bleeding is controlled with 2-3 exactly placed stiches. The pancreatic stump is sunk inside the jejunum, which is tightened around the pancreas with a purse string. A biodegradable stent is left into the pancreatic duct to prevent its occlusion when tightning the purse string.
16323673|NCT00471614|Drug|NucleomaxX (contains uridine)|Escalated doses of NucleomaxX tid
16323674|NCT00471601|Behavioral|counseling intervention|
16323675|NCT00471601|Behavioral|questionnaire administration|
16323676|NCT00471601|Behavioral|psychosocial assessment and care|
16323677|NCT00471601|Behavioral|quality-of-life assessment|
16323678|NCT00471588|Drug|Pramipexole, Amisulpride|Study Drug
16323679|NCT00471575|Procedure|ultra sound examination|
16323680|NCT00471562|Biological|therapeutic angiotensin-(1-7)|sequentially increasing doses 50-1000 mcg/kg
16323681|NCT00471549|Drug|Statin (simvastatin)|
16323682|NCT00471536|Drug|pazopanib hydrochloride|800 mg Given orally
16323683|NCT00471523|Drug|Clomiphene citrate|
16323684|NCT00471523|Drug|Metformin|
16323685|NCT00471510|Drug|tetrapeptide aldehyde proteasome inhibitor (NEOSH101)|Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
16323686|NCT00471497|Drug|nilotinib|Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
16323687|NCT00471497|Drug|imatinib|Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
16323688|NCT00471484|Biological|recombinant interferon alfa-2b|
16323689|NCT00471484|Drug|doxorubicin hydrochloride|
16323690|NCT00471484|Drug|fluorouracil|
16323691|NCT00471484|Drug|oxaliplatin|
16323692|NCT00471484|Other|diagnostic laboratory biomarker analysis|
16323693|NCT00471484|Other|immunoenzyme technique|
16323694|NCT00471484|Other|immunohistochemistry staining method|
16323695|NCT00471484|Procedure|adjuvant therapy|
16323696|NCT00471484|Procedure|biopsy|
16323697|NCT00471484|Procedure|neoadjuvant therapy|
16323698|NCT00471484|Procedure|therapeutic conventional surgery|
16323699|NCT00471471|Biological|Peptide vaccine|Multi-epitope peptide vaccine containing MART-1 (26-35, 27L), gp100 (209-217, 210M) and tyrosinase (368-376, 370D) peptides
16323700|NCT00471471|Biological|GM-CSF|80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
16323701|NCT00471471|Biological|PF3512676|0.6 mg/0.04 mL given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).
16323702|NCT00471445|Drug|ketamine/amitriptyline NP-H cream|Subjects were instructed to apply up to, but not exceeding, 4 g of ketamine/amitriptyline NP-H cream two times per day to each area with pain, numbness, and/or tingling. A measuring device was provided to assist in dispensing the proper amount of the cream.
16323703|NCT00471445|Other|placebo|Applied topically
16323704|NCT00471432|Drug|custirsen sodium|
16323705|NCT00471432|Drug|docetaxel|
16323706|NCT00471432|Other|pharmacological study|
16323707|NCT00471419|Drug|Rimexolone|
16323708|NCT00471406|Procedure|Photodynamic Therapy with Verteporfin|
16323709|NCT00471393|Drug|1.5% diclofenac in 45.5% DMSO (topical treatment)|
16323710|NCT00471393|Drug|45.5% DMSO (topical placebo)|
16323711|NCT00471380|Drug|travoprost 0.004% and brinzolamide 1%|Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)
16323712|NCT00471380|Drug|fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle|group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
16323713|NCT00471367|Drug|AZD4877|intravenous infusion administered twice a week for 2 weeks
16323714|NCT00471354|Drug|Atomoxetine|atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
16323715|NCT00471341|Drug|Celecoxib|
16323716|NCT00471341|Drug|placebo|
16323717|NCT00471328|Drug|Nilotinib|Nilotinib 400 mg twice daily (bid)
16323718|NCT00471328|Other|Best Supportive Care (BSC) +/- imatinib or sunitinib|Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.
16323719|NCT00471315|Drug|Duloxetine|A preliminary, open-label single center study of duloxetine in patients with SOD
16323720|NCT00471289|Device|PTA with placement of paclitaxel-eluting stent|PTA with placement of paclitaxel-eluting stent
16323721|NCT00471289|Device|PTA|PTA
16323722|NCT00471276|Drug|sunitinib|sunitinib (Sutent), 37.5 mg, daily dosing
16323723|NCT00471263|Drug|Casigold|
16323724|NCT00471263|Drug|Casimax|
16323725|NCT00471263|Drug|Placebo|
16323726|NCT00471237|Drug|Ronacaleret|100mg, 200mg, 300mg, 400mg
16323727|NCT00471237|Drug|Teriparatide|PTH (1-34)
16323728|NCT00471237|Drug|Alendronate|Bisphosphonate
16323729|NCT00471224|Other|Observational Trial|No intervention is being used in this study.
16323730|NCT00471211|Drug|PBT2|
16323731|NCT00471185|Drug|Acyline|10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.
16323732|NCT00471172|Behavioral|Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)|
16323733|NCT00471172|Behavioral|Face-to-face counseling by a dietitian (monthly)|
16323734|NCT00471172|Behavioral|Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)|
16323735|NCT00471172|Behavioral|Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)|
16323736|NCT00471172|Behavioral|Self help|
16323737|NCT00471159|Drug|docetaxel|
16323738|NCT00471159|Drug|PF-3512676|
16323739|NCT00471146|Drug|AG-013736|oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.
16323740|NCT00471146|Drug|Gemcitabine|intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
16323741|NCT00471146|Drug|Gemcitabine|intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
16323742|NCT00471146|Drug|placebo|placebo
16323743|NCT00471133|Biological|Xenogeneic Tyrosinase DNA Vaccine|
16323744|NCT00471133|Device|TriGrid Delivery System for Intramuscular Electroporation|
16323745|NCT00471120|Other|P2x7 assay|compare P2X7 assay to biopsy
16323746|NCT00471107|Device|DC brain polarization|0.08 mA/cm2
16323747|NCT00471094|Drug|Ilaprazole|Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
16323748|NCT00471094|Drug|Ilaprazole|Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
16323749|NCT00471094|Drug|Ilaprazole|Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
16323750|NCT00471094|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
16323751|NCT00471081|Biological|Meningococcal vaccine GSK134612|One or 2 intramuscular injections.
16323752|NCT00471068|Drug|Travatan|Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
16323753|NCT00471068|Drug|Cosopt|treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
16323754|NCT00471068|Drug|Placebo (Timolol Vehicle)|Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
16323755|NCT00471055|Drug|"0.0125% Capsaicin gel CAPSIKA gel"|
16323756|NCT00471055|Drug|Placebo|Placebo
16323757|NCT00471042|Drug|Buprenorphine|Dose is determined according to the participants' individual need.
16323758|NCT00471029|Drug|esomeprazole|
16323759|NCT00471016|Behavioral|Guided intervention|
16323760|NCT00471003|Drug|Pritor (Telmisartan , BAY68-9291)|Primary care hypertensive patients starting the therapy with Telmisartan
16323761|NCT00470990|Drug|GnRH antagonist (Acyline)|3 Subcutaneous injections (300 mcg/kg) over 36 days
16323762|NCT00470977|Drug|ranibizumab injection (0.5 mg)|ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
16323763|NCT00470964|Procedure|Titanium Sapphire laser trabeculoplasty|
16323764|NCT00470951|Procedure|open rectal resection|open rectal resection
16323765|NCT00470951|Procedure|laparoscopic rectal resection|laparoscopic assisted rectal resection
16323766|NCT00470938|Device|SpineForce Reactive Neuromuscular Trainer|
16323767|NCT00470925|Drug|123-I MZINT injection and SPECT imaging|SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI
16323768|NCT00470912|Drug|sunscreen RV 2547C|
16323769|NCT00470899|Procedure|drainage of placenta of fetal blood|
16323770|NCT00470886|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan
16323771|NCT00470873|Drug|Levitra (Vardenafil, BAY38-9456)|Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil
16323772|NCT00470860|Behavioral|Participation in LOFTS online tutorial|
16323773|NCT00470847|Drug|Lapatinib|Orally twice daily
16323774|NCT00470847|Procedure|Whole Brain Radiation|15 treatments over a period of 3 weeks
16323775|NCT00470847|Drug|Herceptin|Herceptin 4mg/kg loading dose then 2 mg/kg IV once weekly, then once every three weeks after cycle 3.
16323776|NCT00470834|Drug|dutasteride|0.5mg dutasteride (Investigation Product)
16323777|NCT00470834|Drug|placebo|making placebo
16323778|NCT00470834|Drug|bicalutamide|50 mg Casodex or generic equivalent
16323779|NCT00470821|Drug|Oral melatonin 3mg BID|Identical tablets containing melatonin 3 mg. Nurses are requested to give two tablets daily, at 8 PM and 12 PM
16323780|NCT00470821|Drug|Placebo|Identical tablets without the active principles. Each evening nurses are requested to give 2 tablets at 8 PM and 12 PM
16323781|NCT00470808|Drug|POMx|
16323782|NCT00470795|Other|Acupuncture|acupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment)
16323783|NCT00470795|Procedure|placebo/sham acupuncture|acupuncture at sham points without skin penetration
16323784|NCT00470769|Procedure|Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy|
16323785|NCT00470756|Other|mechanical triggering of peroneal activity|mechanical triggering of peroneal activity
16323786|NCT00470743|Drug|Ibuprofen|
16323787|NCT00470743|Drug|Indomethacin|
16323788|NCT00470717|Procedure|Weekly telephone call|Details of feeding and health/sickness will be obtained
16323789|NCT00470704|Drug|Lapatinib|Oral dose taken daily
16323790|NCT00470704|Drug|Herceptin|Given intravenously once a week or once every 3 weeks
16323791|NCT00470691|Procedure|plaster cast|complete circular plaster cast
16323792|NCT00470691|Procedure|dorsal splint|dorsal plaster splint
16323793|NCT00470678|Drug|ranibizumab|
16323794|NCT00470665|Drug|Rapamune|
16323795|NCT00470652|Device|computer-assisted decision support|at the end of the pre-intervention period, the patient flow software was modified to open popup windows automatically when pain intensity was not documented or pain was not reevaluated within the recommended interval. The popup window also detailed appropriate pain treatment guidelines based on the documented pain intensity. In addition, the patient's icon in the flow software changed from black to red when pain intensity was >4/10. After a 10-day test period, the post-intervention data collection started.
16323796|NCT00470639|Device|Transcranial Magnetic Stimulation|
16323797|NCT00470626|Device|Celect Vena Cava Filter|Effective filtration of inferior vena cava blood to prevent thromboembolism.
16323798|NCT00470613|Genetic|SGT-53|For Phase Ib: SGT-53 (2.4 mg DNA per infusion) will be administered in combination with docetaxel at 40 mg/m2 starting dose, cohort 1, cycle 1. SGT-53 will be administered weekly, on day 1 in weeks 2, 3, 5, and 6, and biweekly on days 1 and 4 in weeks 1, 4, and 7. Docetaxel will be administered every 3 weeks (weeks 1, 4, and 7)on day 3. Patients completing cohort 1, cycle 1 without DLT at 40 mg/m2 docetaxel will be allowed to dose escalate to 60 mg/m2 docetaxel in cycles 2 and 3.Cohort 2 (2.4mg DNA/infusion;75mg/m2 Docetaxel) will open 3 weeks after demonstration of 0/3 or ≤1/6 DLTs at docetaxel 60 mg/m2. Cohort 3 (3.6 mg DNA/infusion; 75 mg/m2 Docetaxel) will open after demonstration of 0/3 or ≤1/6 DLTs at SGT-53 2.4 mg DNA/infusion and docetaxel 75 mg/m2.
16323799|NCT00470600|Drug|Caldolor|800 milligrams intravenous
16323800|NCT00470600|Other|Normal Saline|Placebo comparator
16323801|NCT00470574|Biological|QS21|
16323802|NCT00470574|Biological|sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine|
16323803|NCT00470574|Other|immunoenzyme technique|
16323804|NCT00470574|Other|immunologic technique|
16323805|NCT00470574|Other|laboratory biomarker analysis|
16323806|NCT00470561|Drug|Aspirin|Two 325 mg doses of aspirin per day for 6 months
16323807|NCT00470561|Drug|Placebo|Two placebo pills per day for 6 months
16323808|NCT00470548|Drug|Abraxane|ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
16323809|NCT00470548|Drug|Alimta|Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)
16323810|NCT00470535|Drug|erlotinib hydrochloride|Oral
16323811|NCT00470535|Other|immunohistochemistry staining method|Correlative Study
16323812|NCT00470535|Other|laboratory biomarker analysis|Correlative Study
16323813|NCT00470522|Drug|Methotrexate and folic acid|
16323814|NCT00470509|Drug|Adalimumab|2 subcutaneous injections on day 0 and 7
16323815|NCT00470509|Drug|Placebos|2 subcutaneous injections on day 0 and 7
16323816|NCT00470496|Drug|HPPH|Given IV
16323817|NCT00470496|Drug|photodynamic therapy|Undergo laser light exposure
16323818|NCT00470496|Procedure|conventional surgery|Undergo surgery
16323819|NCT00470483|Drug|Placebo treatment during 8 weeks|comparator
16323820|NCT00470483|Drug|Paroxetine treatment during 8 weeks|treatment drug
16323821|NCT00470470|Drug|imatinib mesylate|Given orally
16323822|NCT00470470|Other|laboratory biomarker analysis|Correlative studies
16323823|NCT00470457|Biological|Allergen specific immunotherapy|
16323824|NCT00470444|Procedure|Transfusion with Red Blood Cells|Units of donated Red blood cells
16323825|NCT00470444|Biological|1 unit of donated red blood cells|Units of red blood cells
16323826|NCT00470444|Biological|1 unit of donated red blood cells|Units of donated red blood cells
16323827|NCT00470418|Drug|NIC5-15|a natural product, found in many foods and plants with mild insulin sensitizing effects
16323828|NCT00470418|Drug|Placebo|placebo comparator
16323829|NCT00470405|Drug|oxaliplatin|75-100 mg/m2 iv infusion Approximately 2 hours beginning approximately 30 minutes after the end of ALIMTA infusion on Day 1 of a 14-days cycle
16323830|NCT00470405|Drug|pemetrexed disodium|a novel antifolate with multiple targets.
16323831|NCT00470392|Drug|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
16323832|NCT00470392|Drug|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
16323833|NCT00470379|Drug|resiquimod|Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.
16323834|NCT00470366|Biological|pegfilgrastim|
16323835|NCT00470366|Drug|cisplatin|
16323836|NCT00470366|Drug|ifosfamide|
16323839|NCT00470353|Dietary Supplement|cholecalciferol|
16323840|NCT00470353|Other|immunohistochemistry staining method|
16323841|NCT00470353|Other|laboratory biomarker analysis|
16323842|NCT00470353|Other|pharmacological study|
16323843|NCT00470353|Procedure|biopsy|
16323844|NCT00470340|Drug|Oxaliplatin, gemcitabine, cisplatin, lipiodol|Oxaliplatin, gemcitabine, cisplatin, lipiodol
16323845|NCT00470314|Drug|L-Ornithine L-Aspartate|
16323846|NCT00470301|Drug|tipifarnib|Given orally
16323847|NCT00470301|Drug|paclitaxel|Given IV
16323848|NCT00470301|Drug|doxorubicin|Given IV
16323849|NCT00470301|Drug|cyclophosphamide|Given IV
16323850|NCT00470288|Procedure|bladder flap during cesarean section|
16323851|NCT00470275|Drug|cytarabine|Given IV
16323852|NCT00470262|Drug|Fenofibrate 145mg PO QD|Subjects will be randomized to either fenofibrates or combination of both fenofibrate and pioglitazone
16323853|NCT00470262|Drug|Pioglitazone 45 mg PO QD|Subjects will be randomized to either fenofibrate 145 mg PO QD or a combination of both fenofibrate 145 mg PO QD and pioglitazone 45 mg PO QD
16323854|NCT00470249|Drug|Carboplatin|At a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle
16323855|NCT00470249|Drug|Gemcitabine Hydrochloride|1500 mg/m2 on day 2 of every 2-week cycle
16323856|NCT00470236|Radiation|Standard WB fractionation|A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
16323857|NCT00470236|Radiation|Shorter WB fractionation|A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
16323858|NCT00470236|Radiation|Standard WB fractionation+Boost|"Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
~Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week."
16323859|NCT00470236|Radiation|Shorter WB fractionation + Boost|"Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
~Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week."
16323860|NCT00470223|Drug|cisplatin|
16323861|NCT00470223|Drug|doxorubicin hydrochloride|
16323862|NCT00470223|Drug|etoposide|
16323863|NCT00470223|Drug|ifosfamide|
16323864|NCT00470223|Drug|methotrexate|
16323865|NCT00470223|Drug|zoledronic acid|
16323866|NCT00470223|Procedure|conventional surgery|
16323867|NCT00470210|Drug|Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week|Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
16323868|NCT00470210|Drug|Ribavirin (Copegus®) 1600 mg/day|Ribavirin (Copegus®) 1600 mg/day
16323869|NCT00470210|Drug|Epoetin β (450 UI/kg/week)|Epoetin β (450 UI/kg/week)
16323870|NCT00470197|Drug|alvocidib|Given IV
16323871|NCT00470197|Drug|cytarabine|Given IV
16323872|NCT00470197|Drug|mitoxantrone hydrochloride|Given IV
16323873|NCT00470197|Other|pharmacological study|Correlative study
16323874|NCT00470184|Drug|capecitabine|Oral
16323875|NCT00470184|Drug|oxaliplatin|IV
16323876|NCT00470184|Genetic|gene expression analysis|Correlative Study
16323877|NCT00470184|Genetic|microarray analysis|Correlative Study
16323878|NCT00470184|Genetic|reverse transcriptase-polymerase chain reaction|Correlative Study
16323879|NCT00470184|Procedure|adjuvant therapy|Metastatic growth control
16323880|NCT00470184|Procedure|biopsy|Examination of tissue type
16323881|NCT00470184|Procedure|conventional surgery|Tissue removal
16323882|NCT00470184|Procedure|neoadjuvant therapy|Tumor shrinkage
16323883|NCT00470184|Procedure|quality-of-life assessment|Correlative Study
16323884|NCT00470184|Radiation|radiation therapy|Undergoing radiation therapy
16323885|NCT00470171|Drug|Ursodesoxycholic acid|
16323886|NCT00470158|Dietary Supplement|iron and zinc combined|Children >= 12 months received an average of 5mg zinc/day, 6.25 Iron/day, and 25IU folic acid/day. children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
16323887|NCT00470158|Dietary Supplement|iron and zinc on separate days|Children >= 12 months received an average of 5mg zinc/day, alternating daily with 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
16323888|NCT00470158|Dietary Supplement|iron|Children >= 12 months received an average 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
16323889|NCT00470158|Dietary Supplement|Zinc|Children >= 12 months received an average of 5mg zinc/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
16323890|NCT00470158|Dietary Supplement|placebo|Children received daily placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
16323891|NCT00470145|Drug|SB-568859|
16323892|NCT00470119|Behavioral|behavioral dietary intervention|A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss
16323893|NCT00470119|Behavioral|Exercise intervention|Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week
16323894|NCT00470106|Behavioral|Cognitive remediation|Computer exercises in attention, memory, and speed of processing.
16323895|NCT00470106|Behavioral|Social Cognitive skills training|Group training on emotion perception, social perception, and understanding others' mental states.
16323896|NCT00470106|Behavioral|hybrid intervention|A combination of the two groups listed above.
16323897|NCT00470106|Behavioral|skills training|Skills training in how to identify symptoms of illness and medication side effects.
16323898|NCT00470093|Biological|recombinant interferon-α|
16323899|NCT00470093|Biological|recombinant interleukin-6|
16323900|NCT00470080|Procedure|venepuncture|venepuncture
16323901|NCT00470067|Drug|carboplatin|IV
16323902|NCT00470067|Drug|pegylated liposomal doxorubicin hydrochloride|IV
16323903|NCT00470054|Drug|dasatinib|Given PO
16323904|NCT00470041|Drug|administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation|
16323905|NCT00470028|Device|Transcranial Magnetic Stimulation|
16323906|NCT00470015|Biological|MART-1 antigen|1000 mcg; Day 1 of a 21 day cycle x 4
16323907|NCT00470015|Biological|IL-2|0.5x10^6/m^2
16323908|NCT00470015|Biological|gp100 antigen|1000 mcg; Day 1 of a 21 day cycle x 4
16323909|NCT00470015|Biological|GM-CSF|300mcg
16323910|NCT00470015|Biological|MART-1a peptide|1000 mcg; Day 1 of a 21 day cycle x 4
16323911|NCT00470002|Drug|Somatropin|
16323912|NCT00469989|Procedure|Infection with hookworm larvae|
16323913|NCT00469976|Drug|bevacizumab|
16323914|NCT00469976|Drug|carboplatin|
16323915|NCT00469976|Drug|enzastaurin hydrochloride|
16323916|NCT00469976|Drug|gemcitabine hydrochloride|
16323917|NCT00469963|Procedure|quality-of-life assessment|quality-of-life assessment
16323918|NCT00469963|Radiation|yttrium Y 90 resin microspheres|radiation therapy
16323919|NCT00469950|Behavioral|exercise training|Exercise training in groups
16323920|NCT00469937|Drug|lithium carbonate|Dose levels Neoadjuvant lithium Concurrent lithium Dose level -1 300mg po QD 300mg po QD Dose level (starting dose) 300mg po BID 300mg po BID Dose level 2 300mg po TID 300mg po TID Dose level 3 300mg po QID 300mg po QID
16323921|NCT00469937|Procedure|cognitive assessment|cognitive assessment
16323922|NCT00469937|Procedure|quality-of-life assessment|quality-of-life assessment
16323923|NCT00469937|Radiation|radiation therapy|Protocol radiotherapy must begin within seven days following initiation of Lithium therapy if day seven falls on a holiday or weekend; it is acceptable to begin treatment the next business day. One treatment of 3Gy will be given daily with the exception of weekends and holidays for a total of (10 fractions) for a total of 30 Gy over 2 to 3 weeks.
16323924|NCT00469924|Procedure|Real Time Clinical Alerting|
16323925|NCT00469911|Procedure|Magnetic Resonance Spectroscopy|Magnetic Resonance Spectroscopy is a noninvasive procedure that provides detailed body images on any plane.
16323926|NCT00469911|Procedure|Ex vivo heart biopsy|Heart transplant patients will have their normal clinical routine heart biopsy
16323927|NCT00469898|Drug|Carboplatin|"Carboplatin dosage calculation to be given on day 1, every 21 days:
~Carboplatin (mg) = (AUC of 5) x (GFR + 25)
~*up to 6 cycles at physician's discretion"
16323928|NCT00469898|Drug|irinotecan hydrochloride|"50 mg/m2 IV on days 1 and 8 every 21 days
~Should be infused IV over 30- 90 minutes."
16323929|NCT00469885|Drug|Nicotine replacement|For reduction
16323930|NCT00469885|Behavioral|Motivational counseling|No drugs
16323931|NCT00469872|Procedure|Context-focused compared to child-focused interventions|
16323932|NCT00469859|Drug|cytarabine|given IV
16323933|NCT00469859|Drug|idarubicin|Given IV
16323934|NCT00469859|Drug|lestaurtinib|Given orally
16323935|NCT00469846|Procedure|L-arginine supplementation in a medical food|
16323936|NCT00469846|Procedure|Vitamin C and E supplementation in a medical food|
16323937|NCT00469833|Drug|insulin glargine|Diabetic subjects will be treated with insulin glargine once daily for 2 months. Subjects will monitor their blood glucose and have their insulin dose adjusted in steps of 4-6 units to achieve a goal of less than or equal to 120 mg/dl for fasting blood glucose.
16323938|NCT00469820|Biological|autologous tumor cell vaccine|
16323939|NCT00469820|Biological|peripheral blood lymphocyte therapy|
16323940|NCT00469794|Procedure|stress test|
16323941|NCT00469781|Drug|2. Xibrom (Bromfenac)|Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
16323942|NCT00469781|Drug|1. Pred Forte|"Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.
~Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks."
16323943|NCT00469768|Drug|dapivirine reservoir intravaginal ring|a silicone elastomer reservoir ring containing 25mg of dapivirine
16323944|NCT00469768|Drug|dapivirine matrix intravaginal ring|a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
16323945|NCT00469768|Other|placebo intravaginal ring|a silicone elastomer intravaginal ring containing no dapivirine
16323946|NCT00469755|Drug|Adapalene Gel, 0.1%|Apply once daily in the evening for 12 weeks
16323947|NCT00469755|Drug|Tazarotene Cream, 0.1%|Apply once daily in the evening for 12 weeks
16323948|NCT00469755|Drug|Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%|Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks
16323949|NCT00469729|Drug|StemEx®|The stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood cells, which is infused to subject at a rate of 1-3 ml/min in combination with non-manipulated cells derived from the same cord blood unit.
16323950|NCT00469716|Drug|Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)|
16323951|NCT00469703|Drug|Thalidomide|
16323952|NCT00469690|Drug|Acular, Xibrom|"Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
~Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)"
16323953|NCT00469664|Drug|Guanfacine/Tenex|
16323954|NCT00469651|Biological|MSP 3 Long Synthetic Peptide|Lyophilized MSP3 vaccine adjuvanted in Aluminium hydroxide
16323955|NCT00469651|Biological|MSP3 vaccine|Lyophilized vaccine adjuvanted in Aluminium hydroxide
16323956|NCT00469651|Biological|Hepatitis B vaccine|Hepatitis B vaccine adjuvanted in Aluminium hydroxide
16323957|NCT00469651|Biological|MSP3 candidate vaccine|Lyophilized MSP3 adjuvanted in Aluminium hydroxide
16323958|NCT00469651|Biological|Hepatitis B control vaccine|Hepatitis B vaccine adjuvanted in Aluminium Hydroxide
16323959|NCT00469638|Procedure|Left atrial catheter ablation guided by introducer using Agilis sheeth|Left atrial catheter ablation guided by introducer using Agilis sheeth
16323960|NCT00469638|Procedure|Left atrial catheter ablation guided by introducer using Non-steerable sheeth|Left atrial catheter ablation guided by introducer using Non-steerable sheeth
16323961|NCT00469625|Drug|paricalcitol (initial dose 1 mcg orally per day)|
16323962|NCT00469612|Device|NeuroVision's NVC treatment for Low Myopia|"NeuroVision's NVC vision correction technology is a method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain).
~The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity and CSF) will be tested in order to continuously monitor a subject's progress."
16323963|NCT00469599|Drug|paricalcitol|3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
16323964|NCT00469599|Drug|alfacalcidol|1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
16323965|NCT00469586|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
16323966|NCT00469586|Drug|metformin|Tablets, 2000 mg/day.
16323967|NCT00469586|Drug|glimepiride|Tablets, 4 mg/day.
16323968|NCT00469586|Drug|inhaled human insulin|Treat-to-target dose titration scheme, post-prandial, inhalation.
16323969|NCT00469573|Drug|1. Optive|Optive 15ml- (in the eye) Instill one drop twice daily in each eye
16323970|NCT00469560|Drug|Deferasirox|
16323971|NCT00469547|Other|62% ethanol in emollient gel|62% ethanol in emollient gel used as a topical male microbicide
16323972|NCT00469547|Drug|Placebo|15% ethanol in emollient gel used as a topical male microbicide
16323973|NCT00469547|Other|15% ethanol in emollient gel|15% ethanol in emollient gel used as a topical male microbicide
16323974|NCT00469534|Procedure|IMRT|
16323975|NCT00469521|Drug|Refresh Tears, 9582X|
16323976|NCT00469508|Drug|Modafinil|400mg pills taken orally daily for 12 wks.
16323977|NCT00469508|Drug|Placebo|400mg pills taken orally daily for 12 wks
16323978|NCT00469495|Drug|Anti-helminthic|
16323979|NCT00469495|Drug|meglumine antimony|
16323980|NCT00469482|Other|Sedation,RASS Targeted plus BIS Monitoring|Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring
16323981|NCT00469482|Other|Sedation, RASS Targeted|Patient sedation utilizing standard of care methods (RASS targeted)
16323982|NCT00469469|Drug|Bevacizumab|
16323983|NCT00469456|Drug|Memantine|Memantine 20mg (10mg twice daily) oral administration for 12 weeks
16323984|NCT00469456|Drug|placebo|Placebo oral administration twice daily for 12 weeks
16323985|NCT00469443|Drug|Irinotecan|Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
16323986|NCT00469443|Drug|5-Fluorouracil|5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
16323987|NCT00469443|Drug|Leucovorin|Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
16323988|NCT00469443|Drug|Capecitabine|Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
16323989|NCT00469443|Drug|Bevacizumab|Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
16323990|NCT00469443|Drug|Bevacizumab|Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
16323991|NCT00469443|Drug|Irinotecan|Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
16323992|NCT00469430|Drug|cefotaxim and metronidazol|iv administration for at least 24 h
16323993|NCT00469417|Procedure|Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream|
16323994|NCT00469404|Drug|Buprenorphine|
16323995|NCT00469391|Device|GI Sleeve Implantable weight loss device (EndoBarrier)|device for weight loss
16323996|NCT00469391|Procedure|Sham Procedure|Weight loss
16323997|NCT00469378|Drug|firategrast|900 (females) or 1200 (males) mg twice daily for 24 weeks
16323998|NCT00469365|Behavioral|pharmacist contact with the patient via telephone|
16323999|NCT00469365|Behavioral|Pharmacist contact with the patient's physician via fax|
16324000|NCT00469365|Behavioral|Usual care|
16324001|NCT00469352|Drug|Ranibizumab|Ranibizumab as needed
16324002|NCT00469326|Drug|Atorvastatin|two days 80mg atorvastatin pre-treatment before PCI
16324003|NCT00469300|Drug|Iontophoretic delivery of acyclovir|
16324004|NCT00469274|Drug|Antibiotic PEP|Azithromycin 1000mg po x 1, then 500mg po Q day for 4 days; TMP-SMX DS one BID for 14 days
16324005|NCT00469274|Drug|Antibiotic PEP|TMP-SMX DS po BID for 14 days
16324006|NCT00469261|Drug|Doxycycline|Doxycycline 100 mg bid for seven days after enrollment
16324007|NCT00469261|Drug|Current medical therapy for AMI|Current medical therapy for AMI
16324008|NCT00469248|Device|Intra-aortic balloon pump counterpulsation|
16324009|NCT00469235|Drug|Avotermin|"10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.
~10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure."
16324010|NCT00469222|Procedure|hypofractionated external beam|
16324011|NCT00469209|Drug|Trisenox (Arsenic Trioxide)|0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
16324012|NCT00469209|Drug|Velcade (Bortezomib)|"Arm 1 (Level 1):
~1.0 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
~Arm 2 (Level 2):
~1.5 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute)."
16324013|NCT00469209|Drug|Melphalan|100 mg/m2 by vein days -4,-3, over 30 minutes
16324014|NCT00469209|Drug|Vitamin C (Ascorbic Acid)|1000 mg once a day through the vein for 7 days.
16324015|NCT00469196|Procedure|Tomotherapy|40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.
16324016|NCT00469183|Drug|Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%|Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
16324017|NCT00469170|Device|intravaginal ring|silicone elastomer intravaginal ring containing no drug product
16324018|NCT00469157|Drug|Optive|Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery
16324019|NCT00469144|Drug|Busulfan|"Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days.
~Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day.
~Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%."
16324020|NCT00469144|Drug|Fludarabine|40 mg/m^2 IV Daily Over 1 Hour x 4 Days
16324021|NCT00469131|Drug|tacrolimus + steroid|
16324022|NCT00469131|Drug|tacrolimus + mycophenolate mofetil|
16324023|NCT00469118|Device|DRX9000™|Nonsurgical spinal decompression
16324024|NCT00469105|Behavioral|Literacy/Numeracy oriented educational intervention|Receives comprehensive literacy/num sensitive diabetes care
16324025|NCT00469105|Behavioral|Control Group|Receives standard diabetes disease management
16324026|NCT00469092|Drug|biphasic insulin aspart|Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
16324027|NCT00469092|Drug|insulin glargine|Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
16324028|NCT00469092|Drug|metformin|Tablets, 2550 mcg. Administered once daily.
16324029|NCT00469092|Drug|glimepiride|Tablets 2 mg. 4, 6 or 8 mg administered once daily.
16324030|NCT00469079|Drug|Nicotine gum and lozenge|Nicotine replacement
16324031|NCT00469079|Other|Taboka|smokeless tobacco product
16324032|NCT00469079|Other|Camel Snus|smokeless tobacco product
16324033|NCT00469053|Drug|Buprenorphine|
16324034|NCT00469040|Drug|GW642444M for 14 days|M salt
16324035|NCT00469027|Biological|eNOS transfected EPCs will be delivered via a PA line|incremental dosing over 3 days
16324036|NCT00469014|Drug|Clofarabine|Day -6 to Day -3 for Arm 1 = 10 mg/m^2 intravenous (IV) Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
16324037|NCT00469014|Drug|Busulfan|"Day -6 to Day -3 for Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily.
~Test dose Day -8 32 mg/ m^2 IV over 45 min, rest on Day -7."
16324038|NCT00469014|Drug|Fludarabine|Day -6 to Day -3 for Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily
16324039|NCT00469014|Other|Stem Cell Infusion|Day 0 stem cell infusion (Bone marrow or peripheral blood progenitor cells (PBPC))
16324040|NCT00469014|Drug|Thymoglobulin (ATG)|Day -3 to Day -1 at 0.5 mg/kg IV on Day -3; 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1.
16324041|NCT00469014|Drug|Filgrastim|Subcutaneous injection daily, starting 1 week after Stem Cell Transplant.
16324042|NCT00469001|Procedure|Treatment according NT Pro BNP level|
16324043|NCT00468988|Drug|Travatan® Z|
16324044|NCT00468988|Drug|Xalatan®|
16324045|NCT00468975|Drug|PF-610,355|
16324046|NCT00468975|Drug|Salmeterol|
16324047|NCT00468962|Drug|FACOS (functional food)|
16324048|NCT00468936|Drug|Myfortic|enteric coated Cellcept pills in applicable dose for patient
16324049|NCT00468923|Drug|Candesartan/HCT|Candesartan 16 mg/HCT 12.5 once daily
16324050|NCT00468923|Drug|Rosuvastatin|Rosuvastatin 10 mg once daily
16324051|NCT00468910|Drug|acetylsalicylic acid|Given orally
16324052|NCT00468910|Drug|placebo|Given orally
16324053|NCT00468910|Other|laboratory biomarker analysis|Correlative study
16324054|NCT00468897|Drug|RSG XR|RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
16324055|NCT00468884|Drug|Increasing doses of GLP-1|
16324056|NCT00468884|Drug|PYY3-36|
16324057|NCT00468871|Drug|fluocinolone acetonide intravitreal implant|surgical intravitreal implant of fluocinolone acetonide
16324058|NCT00468871|Drug|corticosteroids and immunosuppressants|Systemic corticosteroids alone or combined with immunosuppressants
16324059|NCT00468858|Other|Placebo|"Lyophilized, single dose vials and sterile water for
~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
16324060|NCT00468858|Biological|T-DEN-Post-Transfection F17|Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
16324061|NCT00468858|Biological|T-DEN-Post-Transfection F19|Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
16324062|NCT00468845|Drug|pregabalin (Lyrica)|150 mg/day double blind (divided doses)
16324063|NCT00468845|Drug|pregabalin (Lyrica)|300 mg/day double blind (divided doses)
16324064|NCT00468845|Drug|matched placebo|matched placebo
16324065|NCT00468819|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
16324066|NCT00468806|Drug|GSK598809, using [11C]-(+)-PHNO|
16324067|NCT00468793|Procedure|Intravenous fluid|The same intravenous fluids will be used in both arms but the volume will be different
16324068|NCT00468767|Drug|Vernakalant Injection 20 mg/mL|
16324069|NCT00468754|Device|Insulin pumps|
16324070|NCT00468741|Behavioral|CHESS (Comprehensive Health Enhancement Support System)|Full CHESS for subject use
16324071|NCT00468741|Behavioral|CHESS|informational services of CHESS available to subject
16324072|NCT00468741|Behavioral|CHESS|CHESS informational services and social support available to subject
16324073|NCT00468728|Drug|PAR-101/OPT-80|capsules
16324074|NCT00468728|Drug|Vancomycin|Capsules
16324075|NCT00468715|Drug|bicalutamide|
16324076|NCT00468715|Other|diagnostic laboratory biomarker analysis|
16324077|NCT00468715|Other|immunohistochemistry staining method|
16324078|NCT00468702|Device|CoaguChek S|
16324079|NCT00468689|Drug|SB-751689 oral tablets (100 and 400 ng)|
16324080|NCT00468689|Drug|Ketoconazole (NIZORAL) oral tablets (200 mg)|
16324081|NCT00468676|Behavioral|Nurse-led case management|The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.
16324082|NCT00468676|Behavioral|Treatment as usual|Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
16324083|NCT00468650|Drug|sildenafil citrate|Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.
16324084|NCT00468624|Drug|pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks|
16324085|NCT00468624|Procedure|GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo)|
16324086|NCT00468624|Procedure|blood sampling before and after pegvisomant/placebo|
16324087|NCT00468624|Procedure|arginine stimulation test after each limb|
16324088|NCT00468611|Drug|MBP8298|500mg MBP8298 IV every six months for a period of two years
16324089|NCT00468585|Drug|Capecitabine|
16324090|NCT00468585|Drug|Bevacizumab|
16324091|NCT00468572|Behavioral|Affectionate Writing|Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well.
16324092|NCT00468572|Behavioral|Meaningless Writing|Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Participants will undergo the same testing during the writing session as the experimental group.
16324093|NCT00468559|Drug|Open Label Run In Esomeprazole|Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
16324094|NCT00468559|Drug|Double Blind Esomeprazole|Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
16324095|NCT00468559|Drug|Double Blind Placebo|Double Blind Placebo
16324096|NCT00468546|Drug|MabThera/Rituxan|1
16324097|NCT00468546|Drug|Methotrexate|2
16324098|NCT00468546|Other|Placebo|3
16324099|NCT00468533|Drug|Aripiprazole|
16324100|NCT00468520|Drug|low dose oxytocin|
16324101|NCT00468507|Dietary Supplement|nutritional intervention with Respifor and Diasip|Four nutritional interventions on four separate days per test person
16324102|NCT00468481|Drug|Drospirenone/Ethinylestradiol/Methyltetrahydrofolate|0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
16324103|NCT00468481|Drug|Drospirenone/Ethinylestradiol (Yaz)|0.020 mg ethinylestradiol with 3.0 mg drospirenone
16324104|NCT00468468|Behavioral|CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor|computer based education and support
16324105|NCT00468455|Procedure|Laparoscopic or open colorectal surgery|Application of a post-operative diary to be completed by subjects. The intervention is standard of care laparoscopic or open surgery.
16324106|NCT00468442|Biological|Allogeneic Pancreatic Islet Cells|transplant of islet cells injected into the portal vein of the liver
16324107|NCT00468442|Biological|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
16324108|NCT00468442|Biological|Daclizumab|Will replace antithymocyte globulin in all islet transplantations after the first one
16324109|NCT00468442|Biological|Rituximab|Depletes transient B-cells
16324110|NCT00468442|Drug|Sirolimus|Maintenance immunosuppressive therapy
16324111|NCT00468429|Drug|Subconjunctival Bevacizumab|
16324112|NCT00468416|Device|Compression Anastomosis Ring (CAR)|
16324113|NCT00468403|Biological|Allogeneic Pancreatic Islet Cells|Transplant of islet cells from a healthy pancreas. A dose of at least 5,000 Islet Equivalents (IEQ)/kg recipient body weight (BW) infused intraportally for the first transplant, and at least 4,000 IEQ/kg recipient BW infused intraportally for subsequent transplants.
16324114|NCT00468403|Biological|Belatacept|Belatacept is an inhibitor of the 2 signals that stimulate T-cells. Subjects will receive NULOJIX® (belatacept)10mg/kg through a peripheral vein on Day 0 and post-operative days 4, 14, 28, 56, 84. After Day 84 subjects will receive belatacept at a maintenance dose of 5 mg/kg every 4 weeks for the duration of study follow-up (2 years after the final islet transplant). Infusion doses will be based upon the subject's actual body weight at study Day 0 and will not be modified during the course of the study unless there is a change in body weight plus or minus 10% of Day 0 body weight.
16324115|NCT00468403|Biological|Basiliximab|Immunosuppressive medication for prophylaxis of acute transplant rejection. Two Intravenous (IV) doses of basiliximab, a monoclonal antibody Interleukin 2 (IL-2) receptor blocker, will be given with the first and second (if necessary) transplants. The first dose will be 20 mg and will be given within two hours prior to islet transplant on the day of islet transplantation. The second 20 mg dose will be given on Day 4 after the transplant.If a third islet transplant is deemed necessary and performed more than 70 days after the second transplant, both doses of basiliximab will be repeated. No additional doses of basiliximab will be given with a third transplant that is performed between 30 and 70 days after the second transplant.
16324116|NCT00468403|Drug|Mycophenolate Mofetil|Maintenance immunosuppressive therapy. Subjects will receive mycophenolate mofetil starting immediately pre-transplant on Day 0 at a dose of 1g orally twice a day for the duration of study follow-up (2 years after the final islet transplant).
16324117|NCT00468403|Drug|Tacrolimus|Tacrolimus may be used only as a supplement to maintenance mycophenolate mofetil (MMF) in those cases where the trough level is below the therapeutic range. Tacrolimus will be administered orally twice a day to maintain trough levels of 3-5 ng/mL. Generic equivalents of Prograf® will not be permitted.
16324118|NCT00468403|Procedure|Intraportal infusion of islet cells|The infusion of allogeneic pancreatic islet cells (islet transplant[s]) will occur intraportally.
16324119|NCT00468364|Drug|insulin glargine|
16324120|NCT00468364|Drug|NPH insulin|
16324121|NCT00468351|Procedure|Intravitreal Injection of 1,5 mg of bevacizumab|
16324122|NCT00468351|Procedure|Intravitreal injection of 4 mg of Triamcinolone acetonide|
16324123|NCT00468338|Device|BIS monitor|BIS monitor measures the depth of anesthesia and was used in the entire group
16324124|NCT00468325|Procedure|Multi-slice computed tomography|Patient receives a CT scan (multi-slice computed tomography) of the heart.
16324125|NCT00468325|Procedure|Rest-stress Nuclear Myocardial Perfusion Imaging|Patient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution.
16324126|NCT00468325|Procedure|Multi-slice Computed Tomography|Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart.
16324127|NCT00468312|Drug|Mometasone furoate nasal spray|Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning
16324128|NCT00468312|Drug|Placebo|Two sprays in each nostril in the morning
16324129|NCT00468299|Drug|Misoprostol and placebo|Women in this group receive 800 mcg misoprostol plus a placebo
16324130|NCT00468299|Drug|Mifepristone and misoprostol|This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally
16324131|NCT00468286|Drug|Degarelix|"Experimental
~Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months."
16324132|NCT00468286|Drug|Degarelix|"Experimental
~Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months."
16324133|NCT00468273|Drug|Immune Globulin Intravenous (Human) Omr-IgG-am IGIV|IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
16324134|NCT00468260|Drug|Patupilone|
16324135|NCT00468247|Device|Navigator|Navigator circulatory mgt system
16324136|NCT00468247|Other|Conventional care|Conventional haemodynamic care
16324137|NCT00468234|Drug|nicotine polacrilex|
16324138|NCT00468234|Drug|nicotine transdermal system|
16324139|NCT00468234|Drug|nicotine inhaler|
16324140|NCT00468221|Drug|Ozone Exposure|Low dose ozone exposure in chamber
16324141|NCT00468208|Drug|Abatacept|"A participant's abatacept dose depended on body weight and will remain the same throughout the study:
~500 mg of abatacept for body weight less than 60 kg
~750 mg of abatacept for body weight between 60 and 100 kg
~1000 mg of abatacept for body weight greater than 100 kg
~Abatacept is administered in a 30-minute intravenous infusion."
16324142|NCT00468182|Drug|Interferon-beta 1b (Betaseron)|Treatment of patients with FDA-approved Rx
16324143|NCT00468169|Drug|Cetuximab|250mg/m2(day 1, weekly x 10);
16324144|NCT00468169|Drug|5-FU|600 mg/m2/day; days 0-5 (120 h total) every other week x 5
16324145|NCT00468169|Drug|Hydroxyurea|500 mg PO BID, days 0-5 every other week x 5
16324146|NCT00468169|Radiation|Twice-daily radiation|150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
16324147|NCT00468169|Drug|Cisplatin|100 mg/m2, week 1 and 4 on day 1 (or 2)
16324148|NCT00468169|Radiation|Accelerated fraction radiotherapy with concomitant boost|72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
16324149|NCT00468156|Behavioral|written materials only|related to fruit/vegetable servings/day
16324150|NCT00468156|Behavioral|written materials|related to fruit/vegetable servings/day
16324151|NCT00468156|Behavioral|telephone support|related to fruit/vegetable servings/day
16324152|NCT00468143|Drug|Adderall ® Immediate Release|Adderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration.
16324153|NCT00468143|Drug|Adderall XR ®|Adderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.
16324154|NCT00468130|Drug|Aripiprazole|Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects
16324155|NCT00468130|Drug|Placebos|"Inactive tablet made to resemble active tablet
~Subjects under 40 kg will be started on 2.5mg per day of placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects"
16324156|NCT00468117|Procedure|Islet transplantation|
16324157|NCT00468117|Biological|Antithymocyte Globulin|Participants will begin receiving ATG 2 days prior to the initial islet transplant and will continue to receive ATG until Day 2 post-transplant.
16324158|NCT00468117|Biological|Daclizumab or Basiliximab|Daclizumab or Basiliximab will be used for subsequent transplants.
16324217|NCT00467662|Drug|Acyclovir 5%|
16324159|NCT00468117|Biological|Etanercept|Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
16324160|NCT00468117|Biological|Allogenic human purified pancreatic islets|200 ml suspension of allogenic human purified islets
16324161|NCT00468104|Drug|Alteplase|25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days
16324162|NCT00468104|Drug|Placebo|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days
16324163|NCT00468091|Drug|exendin(9-39)amide|
16324164|NCT00468091|Drug|atropine|
16324165|NCT00468078|Procedure|PET/CT|10min acquisition, 90min after injection of F-18 FPCIT
16324166|NCT00468078|Drug|F-18 FPCIT|5mCi, intravenous injection
16324167|NCT00468065|Device|VeinViewer|Veinveiwer is used to view veins subQ
16324168|NCT00468065|Device|Veinviewer|near infrared light reveals veins subcutaneously
16324169|NCT00468052|Drug|dexmedetomidine|2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion
16324170|NCT00468052|Drug|fentanyl|1 microgram/kilogram as a bolus
16324171|NCT00468039|Drug|vildagliptin + metformin|
16324172|NCT00468026|Device|ProstaPlant Stent|
16324173|NCT00468013|Behavioral|Resilience Building Exercises|Weekly exercises for 6 weeks
16324174|NCT00468013|Behavioral|Journaling|Weekly exercises for 6 weeks
16324175|NCT00468000|Biological|Ixmyelocel-T|IM injection
16324176|NCT00468000|Biological|Placebo|IM Injection
16324177|NCT00467987|Drug|androgel|androgel 1%
16324178|NCT00467987|Drug|placebo|placebo
16324179|NCT00467974|Procedure|TEA with LEM|Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
16324180|NCT00467974|Procedure|TACE|Transarterial chemoembolisation (TACE)
16324181|NCT00467961|Combination Product|Miltenyi system|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach.
16324182|NCT00467948|Drug|cefazolin|
16324183|NCT00467935|Drug|intravitreal injection Lucentis (ranibizumab)|intravitreal injection Lucentis (ranibizumab)
16324184|NCT00467922|Drug|Hextend|Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
16324185|NCT00467922|Drug|Lactated Ringers|Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
16324186|NCT00467909|Behavioral|micronutrients|
16324187|NCT00467896|Drug|Iloprost PD-6|Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.
16324188|NCT00467896|Drug|Iloprost PD-15|Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.
16324189|NCT00467883|Drug|Liposomal Amphotericin B|high dosage
16324190|NCT00467870|Drug|Testosterone Undecanoate 750 mg|
16324191|NCT00467870|Drug|Testosterone Undecanoate 1000 mg|
16324192|NCT00467857|Procedure|InteguSeal* skin sealant and standard surgical preparation|Surgical skin preparation prior to incision using InteguSeal* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
16324193|NCT00467857|Other|Standard preoperative skin preparation|Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
16324194|NCT00467844|Drug|GTx-024|1 mg GTx 024
16324195|NCT00467844|Drug|GTx-024|3 mg GTx-024
16324196|NCT00467844|Drug|Placebo|Matching Placebo
16324197|NCT00467831|Drug|Losartan|Losartan potassium tablet, 25 mg by mouth every night at bedtime.
16324198|NCT00467831|Drug|Zileuton|Zileuton tablet, 1200 mg by mouth twice daily.
16324199|NCT00467831|Drug|N-Acetylcysteine|N-acetylcysteine solution, 600 mg by mouth three times daily.
16324200|NCT00467831|Drug|Pravastatin|Pravastatin sodium tablet, 20 mg by mouth every night at bedtime.
16324201|NCT00467831|Drug|Erythromycin|Erythromycin tablet, 333 mg by mouth three times daily.
16324202|NCT00467818|Drug|Omega 3 fatty acids|The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
16324203|NCT00467818|Other|Placebo|Same dosage as that of omega 3 fatty acids
16324204|NCT00467805|Procedure|Light therapy|
16324205|NCT00467779|Drug|cobimetinib|Repeating oral dose
16324206|NCT00467779|Drug|dextromethorphan|In Stage III only: single dose of dextromethorphan
16324207|NCT00467779|Drug|midazolam|In Stage III only: single dose of midazolam
16324208|NCT00467766|Behavioral|Psychosocial information, counseling, and support|
16324209|NCT00467766|Drug|Donepezil (Aricept)|
16324210|NCT00467753|Drug|Oxcarbazepine|Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose.
16324211|NCT00467753|Other|Placebo/sugar pill|Dosage similar to active drug
16324212|NCT00467740|Drug|BI 1744 CL|
16324213|NCT00467727|Other|Phase Contrast Mammography|Standard and magnification views
16324214|NCT00467714|Procedure|rhinoplasty|COLUMELLA STRUT PLACEMENT
16324215|NCT00467688|Device|Real time access to current glucose values during CGMS|One arm gets real time access to current measured glucose values and hypoglycemic or hyperglycemic alerts are elicited, The second arm get´s a retrospective analysis of glucose values
16324216|NCT00467675|Device|CGM System for Type 1 and Type 2 Diabetes Mellitus|
16324220|NCT00467649|Drug|pramlintide acetate (Symlin)|subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
16324221|NCT00467649|Drug|rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])|subcutaneous injection, dosing based on titration guidelines
16324222|NCT00467649|Drug|basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])|subcutaneous injection, dosing based on titration guidelines
16324223|NCT00467636|Procedure|Blood glucose monitoring|Regular pre and post meal blood glucose monitoring.
16324224|NCT00467636|Drug|Insulin Glulisine|Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI < 30 = 0.1 unit/kg. BMI > 30 = 0.2 unit/kg)
16324225|NCT00467610|Drug|Panhematin|
16324226|NCT00467597|Drug|Levodopa (delivered intravenously)|"IV Levodopa is given from 09:00 to 11:00 am during the testing phase of the study. The IV Levodopa allows the researchers to watch one full on and off levodopa cycle while in the inpatient unit."
16324227|NCT00467584|Drug|High Dose Aspirin (1300 mg/day)|1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
16324228|NCT00467584|Drug|Low Dose Aspirin (162 mg/day)|162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
16324229|NCT00467584|Drug|Placebo|Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
16324230|NCT00467571|Drug|lansoprazole, clarithromycin, amoxycillin|lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days
16324231|NCT00467558|Drug|Naltrexone|daily
16324232|NCT00467558|Drug|Sugar pill|daily
16324233|NCT00467545|Drug|telbivudine|
16324234|NCT00467519|Biological|Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)|0.5 mL, IM
16324235|NCT00467519|Biological|DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)|0.5 mL, IM
16324236|NCT00467506|Drug|bispecific antibody and di-DTPA-131I|
16324237|NCT00467493|Drug|Anastrozole|
16324238|NCT00467467|Drug|Alfuzosin Hydrochloride|
16324239|NCT00467454|Drug|Naltrexone|daily
16324240|NCT00467454|Drug|Placebo|daily
16324241|NCT00467441|Drug|VSF-173|
16324242|NCT00467428|Drug|NS2359|
16324243|NCT00467428|Drug|Placebo|
16324244|NCT00467415|Behavioral|Partial body weight support treadmill training|Treadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
16324245|NCT00467415|Behavioral|Exercise|Functional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
16324246|NCT00467402|Drug|agomelatine|
16324247|NCT00467402|Drug|placebo|
16324248|NCT00467389|Drug|Donepezil, 5 mg daily|This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
16324249|NCT00467389|Other|Oral Placebo|Inactive Comparator with Similar Appearance to Active Medication
16324250|NCT00467376|Drug|Insulin Glulisine|3 times a day before each meal
16324251|NCT00467376|Drug|Lispro|3 times a day before each meal
16324252|NCT00467376|Drug|Insulin Glargine|once daily
16324253|NCT00467363|Drug|acetylsalicylic-acid (aspirin)|81mg of low-dose aspirin plus 400micrograms of folic acid.
16324254|NCT00467363|Dietary Supplement|Folic acid|400micrograms of folic acid.
16324255|NCT00467350|Drug|PEG 3350|PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
16324256|NCT00467350|Drug|milk and molasses enema|enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
16324257|NCT00467337|Procedure|Medial-Wedge Insole intervention|
16324258|NCT00467324|Device|Aspire Medical Advance System|The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
16324259|NCT00467298|Behavioral|Exercise adherence|The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.
16324260|NCT00467298|Behavioral|Self-management- prevention of illness|Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.
16324261|NCT00467298|Behavioral|Self-management of illness|This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.
16324262|NCT00467272|Drug|Daptomycin|6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for SA and at least 7 days for enterococci and CNS, Corynebacterium, and Propionibacterium.
16324263|NCT00467259|Drug|Testosterone Transdermal System|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
16324264|NCT00467259|Drug|Placebo patch|placebo patch, changed twice a week for 52 weeks
16324265|NCT00467246|Drug|Levemir|
16324266|NCT00467233|Procedure|Laser Treatment|Laser treatment to half of the face at each study visit
16324267|NCT00467233|Procedure|Acid Peel|Acid peel to half of the face at each study visit
16324268|NCT00467220|Behavioral|calorie restriction|"Subjects in the calorie restriction arm and the alternate day fasting arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction."
16324269|NCT00467207|Drug|Botulinum Toxin A|
16324270|NCT00467207|Behavioral|Resistance training|
16324271|NCT00467194|Drug|Rapamycin|
16324272|NCT00467194|Drug|Bevacizumab|
16324273|NCT00467181|Drug|Fenoldopam|
16324274|NCT00467168|Behavioral|Diet|
16324275|NCT00467142|Biological|bevacizumab|
16324276|NCT00467142|Drug|fluorouracil|
16324277|NCT00467142|Drug|irinotecan hydrochloride|
16324278|NCT00467142|Drug|leucovorin calcium|
16324279|NCT00467142|Genetic|polymorphism analysis|
16324280|NCT00467129|Genetic|microarray analysis|
16324281|NCT00467129|Genetic|mutation analysis|
16324282|NCT00467129|Genetic|polymerase chain reaction|
16324283|NCT00467129|Genetic|polymorphism analysis|
16324284|NCT00467129|Other|laboratory biomarker analysis|
16324285|NCT00467129|Other|questionnaire administration|
16324286|NCT00467116|Biological|cetuximab|400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.
16324287|NCT00467116|Drug|gemcitabine hydrochloride|"Dose Level Gemcitabine dose Gemcitabine infusion
~-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes
~300mg/m2 30 minutes
~400mg/m2 40 minutes"
16324288|NCT00467116|Radiation|radiation therapy|"50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm.
~The prescription point will be designated at the intersection of the multiple beams.
~There are no planned interruptions > 3 days."
16324289|NCT00467077|Biological|PEG-interferon alfa-2b|PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks
16324290|NCT00467077|Drug|gefitinib|ZD1839 will be administered at a dose of 250 mg orally once daily,
16324291|NCT00467064|Behavioral|Arthritis Quick Start|Two week, lay led, workshop focusing on goal setting, problem solving, and content specific to disease management.
16324292|NCT00467064|Other|Delayed treatment intervention|After four months delay, participants in Control Group receive Experimental workshop.
16324293|NCT00467051|Drug|Carboplatin|Given IV
16324294|NCT00467051|Biological|Filgrastim|Given IV or subcutaneously
16324295|NCT00467051|Drug|Ifosfamide|Given IV
16324296|NCT00467051|Other|Laboratory Biomarker Analysis|Optional correlative studies
16324297|NCT00467051|Drug|Paclitaxel|Given IV
16324298|NCT00467038|Behavioral|Dialectical Behavior|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
16324299|NCT00467025|Drug|AMG 386|3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
16324300|NCT00467025|Drug|Sorafenib|400 mg PO BID
16324301|NCT00467025|Drug|AMG 386 placebo IV|AMG 386 placebo IV
16324302|NCT00467012|Drug|bevacizumab|10mg/kg，Day1, 15 of 1 cycle(4 weeks)
16324303|NCT00467012|Drug|Paclitaxel|90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
16324304|NCT00466999|Drug|misoprostol|single dose of 400 mcg misoprostol administered sublingually
16324305|NCT00466999|Procedure|surgery|standard surgical treatment (dilation and curettage or manual vacuum aspiration)
16324306|NCT00466986|Drug|Abraxane|Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days
16324307|NCT00466973|Device|Dry bipolar radiofrequency (RF) clamp|Specified device used for ablation during standard surgical procedure
16324308|NCT00466973|Device|Unipolar microwave antenna|Specified device used for ablation during standard surgical procedure
16324309|NCT00466973|Device|Unipolar cryothermic probe|Specified device used for ablation during standard surgical procedure
16324310|NCT00466973|Device|Irrigated unipolar RF antenna|Specified device used for ablation during standard surgical procedure
16324311|NCT00466973|Device|Irrigated bipolar RF clamp|Specified device used for ablation during standard surgical procedure
16324312|NCT00466973|Device|Hi-intensity focused ultrasound wand|Specified device used for ablation during standard surgical procedure
16324313|NCT00466960|Biological|sargramostim|Given SC
16324314|NCT00466960|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16324315|NCT00466960|Other|laboratory biomarker analysis|Correlative studies
16324316|NCT00466960|Other|immunologic technique|Correlative studies
16324317|NCT00466947|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 4 doses
16324318|NCT00466947|Biological|Havrix|Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
16324319|NCT00466947|Biological|Engerix-B|Intramuscular injection, 3 doses
16324320|NCT00466947|Biological|Infanrix hexa|Intramuscular injection,3 doses
16324321|NCT00466947|Biological|GSK Biologicals' DTPa-IPV/Hib vaccine|Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
16324322|NCT00466921|Drug|lenalidomide|10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.
16324323|NCT00466908|Device|Pentacam and IOL Master|Pentacam and IOL Master
16324324|NCT00466895|Drug|lenalidomide|Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
16324325|NCT00466882|Device|Inamed Lap-Band System|Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years.
16324326|NCT00466869|Drug|Betahistine|
16324327|NCT00466856|Drug|octreotide acetate|"Lung/liver Ratio Dose of SIR-Spheres
~<10% Administer full dose of SIR-Spheres
~10% to 15% Reduce dose of SIR-Spheres by 20%
~16% to 20% Reduce dose of SIR-Spheres by 40%
~>20% Do not give SIR-Spheres"
16324328|NCT00466856|Radiation|yttrium Y 90 resin microspheres|radiation
16324329|NCT00466843|Drug|Antithymocyte globulin (ATG)|ATG 2.5 mg/kg/day via IV will be given for 4 doses. Each participant will receive only one cycle of therapy. The daily infusion will be administered over at least 6 hours and slowed as necessary to minimize infusion-related symptoms.
16324330|NCT00466843|Drug|Prednisone|All participants will be pre-treated with prednisone (1 mg/kg/day by mouth) 2 days prior to the first ATG does and continuing for 14 days after the final dose to prevent serum sickness
16324331|NCT00466830|Other|questionnaire administration|
16324332|NCT00466830|Procedure|management of therapy complications|
16324333|NCT00466830|Procedure|psychosocial assessment and care|
16324334|NCT00466830|Procedure|quality-of-life assessment|
16324335|NCT00466817|Other|Placebo|9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.
16324336|NCT00466817|Drug|Valganciclovir|Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
16324337|NCT00466804|Procedure|Heart transplant|People in this study will have a heart transplant and be monitored for signs of rejection
16324338|NCT00466791|Drug|Methylphenidate Transdermal System|Placebo
16324339|NCT00466765|Device|Brava Autologous Fat Transfer System|Number of procedures is based on patient need
16324340|NCT00466752|Drug|sorafenib tosylate|Given PO
16324341|NCT00466752|Genetic|microarray analysis|Correlative studies
16324342|NCT00466752|Other|immunohistochemistry staining method|Correlative studies
16324343|NCT00466752|Genetic|gene expression analysis|Correlative studies
16324344|NCT00466752|Procedure|needle biopsy|Correlative studies
16324345|NCT00466752|Procedure|therapeutic conventional surgery|Undergo prostatectomy
16324346|NCT00466752|Other|laboratory biomarker analysis|Correlative studies
16324347|NCT00466752|Genetic|western blotting|Correlative studies
16324348|NCT00466752|Genetic|RNA analysis|Correlative studies
16324349|NCT00466726|Biological|bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine|
16324350|NCT00466726|Biological|sargramostim|
16324351|NCT00466713|Drug|Rosiglitazone therapy|
16324352|NCT00466687|Biological|bevacizumab|10mg/kg, slow IV infusion, Days 1 and 14
16324353|NCT00466687|Drug|erlotinib hydrochloride|150mg PO qd
16324354|NCT00466687|Genetic|fluorescence in situ hybridization|Targeting multiple genetic aberrations in isolated tumor cells.
16324355|NCT00466687|Genetic|gene expression analysis|gene expression analysis
16324356|NCT00466687|Other|immunologic technique|immunologic technique
16324357|NCT00466687|Other|laboratory biomarker analysis|laboratory biomarker analysis
16324358|NCT00466687|Procedure|biopsy|biopsy
16324359|NCT00466674|Drug|reduced intensity conditioning|reduced intensity conditioning for allogenic transplant
16324360|NCT00466661|Drug|Acamprosate|666 mg po TID
16324361|NCT00466661|Drug|Placebo|2 tabs po TID
16324362|NCT00466648|Procedure|Tissue adhesive|
16324363|NCT00466635|Drug|GT267-004 (tolevamer potassium sodium)|
16324364|NCT00466622|Drug|Metformin|1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
16324365|NCT00466622|Drug|Placebo|Placebo 2 tablets x 2 daily. Orally from Weifa
16324366|NCT00466609|Drug|Clomipramine (fluoxetine plus clomipramine)|Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
16324367|NCT00466609|Drug|Quetiapine (fluoxetine plus quetiapine)|Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
16324368|NCT00466609|Drug|Placebo (fluoxetine plus placebo)|Placebo plus fluoxetine at maximum dosage of 80mg per day
16324369|NCT00466596|Drug|Gamma Tocopherol|14 days of daily high dose (1200mg) Gamma Tocopherol. Subjects will receive a 14 day supply (28 softgel capsules, approximately 600 grams of gT each) dispensed by the University of North Carolina Hospitals Investigational Drug Service and provided by YASOO Medical.
16324370|NCT00466583|Drug|Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)|IV infusion of EZN 2968 given in 6 week cycles for (3 weeks on 3 weeks off) until recommended phase 2 dose identified. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.
16324371|NCT00466570|Drug|gatifloxacin, moxifloxacin|
16324372|NCT00466544|Device|Plasmaknife|
16324373|NCT00466544|Device|Monopolar|
16324374|NCT00466531|Biological|therapeutic autologous lymphocytes|
16324375|NCT00466531|Drug|cyclophosphamide|
16324376|NCT00466518|Drug|Administration of sitagliptin|Sitagliptin 100 mg daily for 3 months
16324377|NCT00466505|Biological|cetuximab|400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
16324378|NCT00466505|Drug|celecoxib|200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.
16324379|NCT00466505|Genetic|proteomic profiling|Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. We will use LC-MS-MS or MALDITOF mass spectrometry.
16324380|NCT00466505|Other|immunohistochemistry staining method|phospho-EGFR levels using western blots of tissue extracts and immunohistochemistry on frozen and (if no other option available, paraffinembedded tissue sections).
16324381|NCT00466505|Other|laboratory biomarker analysis|Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction.
16324382|NCT00466505|Other|mass spectrometry|We will use LC-MS-MS or MALDITOF mass spectrometry. Before any tissues are received, the drug of interest is evaluated via MALDI mass spectrometry on a MDS/Sciex QStar QqTOF mass spectrometer.
16324383|NCT00466492|Procedure|Sedation or no sedation during mechanical ventilation|No sedation to critically ill patients
16324384|NCT00466479|Drug|brimonidine|
16324385|NCT00466479|Procedure|laser trabeculoplasty|
16324386|NCT00466466|Drug|Everolimus|RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
16324387|NCT00466453|Behavioral|knowledge-adaptive Web-based instruction|
16324388|NCT00466440|Drug|enzastaurin|1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
16324389|NCT00466440|Drug|placebo|Loading dose, then po QD until unblinding
16324390|NCT00466440|Drug|docetaxel|75 mg/m^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
16324391|NCT00466440|Drug|prednisone|5 mg po BID, six 21-day cycles
16324392|NCT00466414|Device|Polycaprolactone Scaffold|
16324393|NCT00466401|Drug|Simvastatin|
16324394|NCT00466401|Drug|Ezetimibe|
16324395|NCT00466375|Genetic|Cheek cell samples or blood sample (4mL)|DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.
16324396|NCT00466375|Genetic|Cheek cell sample or blood sample (4mL)|DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly.
16324397|NCT00466362|Behavioral|The Evje Model|
16324398|NCT00466323|Behavioral|Family Member Provider Outreach|Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
16324399|NCT00466323|Behavioral|Enhanced treatment as usual (e-TAU)|Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
16324400|NCT00466310|Drug|Aripiprazole|Aripiprazole for 4 weeks
16324401|NCT00466310|Drug|Risperidone|Subjects will be randomized to risperidone for 4 weeks
16324402|NCT00466310|Other|Healthy volunteers|Healthy volunteers
16324403|NCT00466297|Behavioral|Face-to-face communication interactions|
16324404|NCT00466284|Drug|Tarceva (erlotinib)|
16324405|NCT00466258|Drug|R-CHOP|"Cyclophosphamide 750 mg/m2 i.v. day 1
~Adriamycin 50 mg/m2 i.v. day 1
~Vincristine 1,4 mg/m2 i.v. day 1
~Prednisone 100 mg i.v or oral. days 1-5."
16324406|NCT00466258|Drug|Highly active antiretroviral therapy|Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
16324407|NCT00466258|Drug|Central nervous system (CNS) prophylaxis|methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
16324408|NCT00466258|Drug|Prophylaxis of opportunistic infections and support treatment|Pegfilgrastim
16324409|NCT00466245|Drug|MVA Smallpox vaccine|Two 0.5mL subcutaneous injections, separated by 28 days
16324410|NCT00466245|Drug|Placebo|Two 0.5mL subcutaneous injections, separated by 28 days
16324411|NCT00466232|Drug|Topotecan|4 mg/m2 IV on day 1, 8, 15. Repeat every 28 days.
16324412|NCT00466232|Drug|Sorafenib|Dose escalation study at 3 dose levels: 200 mg po daily, 200 mg po bid, 400 mg po bid.
16324413|NCT00466219|Drug|Ribavirin|
16324414|NCT00466219|Drug|Pegylated interferon alpha2a|
16324415|NCT00466206|Device|Magnetic Mini-Mover Procedure (3MP)|"A rare earth magnet encased in FDA-approved titanium will be implanted securely on the outer surface of the lower end of the sternum in patients with pectus excavatum. This is accomplished as an outpatient procedure, under brief general anesthesia.
~A 2-inch transverse skinline incision is made at the junction of the sternum and xyphoid and the space in front and behind the sternum is dissected bluntly. The titanium can containing the magnet is securely fixed to the sternum by screwing it into a titanium fixation disk in front of the sternum. The procedure takes 1/2-hour, and the patient can go home the same day.
~In another outpatient procedure, the Magnimplant is explanted 18 months after implantation."
16324416|NCT00466206|Device|Magnatract (external magnet in a removable external brace)|"An external orthotic device Magnatract which includes an external magnet in a removable brace is fitted specifically to the patient's chest wall deformity. A calibrated meter in the external device measures the force applied between the two magnets. When the patient and family are comfortable with the device and comfort and skin condition have been assessed, the patient will be allowed to take the Magnatract home and begin the process of gradually advancing the sternum forward as the abnormal costal cartilage is reformed."
16324417|NCT00466206|Procedure|3MP (Magnetic Mini-Mover Procedure)|"Subject has EKG performed to measure baseline cardiac activity.
~Magnimplant is implanted.
~After one week, Magnatract is fitted.
~Chest x-ray and 2nd EKG performed 30 days post-implantation.
~Patient and parents complete QoL questionnaire 30d post-implantation.
~Patient seen weekly for first month post-implantation to assess comfort and skin condition. Thereafter, will be seen monthly.
~At each monthly visit, patient will have lateral and anterior-posterior chest X-rays to monitor sternal correction.
~At each visit data logger is downloaded to measure strength of pull since last visit and amount of wear-time.
~Magnimplant explanted 18 months later as 1/2-hr outpatient procedure.
~CT scan and third EKG performed after explanation.
~Patient and parents complete QOL questionnaires after explantation and 1 yr post-explantation."
16324418|NCT00466193|Drug|zolpidem tartrate sublingual tablet|3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16324419|NCT00466193|Drug|Placebo|Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16324420|NCT00466180|Behavioral|Nevirapine from twice-a-day to once-a-day|
16324421|NCT00466167|Drug|Pramipexol Extended Release|
16324422|NCT00466167|Drug|Pramipexol Immediate Release|
16324423|NCT00466167|Drug|Placebo|
16324424|NCT00466154|Drug|Aspirin|
16324425|NCT00466141|Behavioral|Increased Exercise for weight loss maintenance|
16324426|NCT00466141|Behavioral|Daily Self-weighing for weight loss maintenance|
16324427|NCT00466141|Behavioral|Education for weight loss maintenance|
16324428|NCT00466128|Drug|indomethacin|Indomethacin 50mg PO followed by 25mg PO q6hrs
16324429|NCT00466102|Drug|RAD001|Tablet of 5 mg, 2 tablets (10 mg) are taken once daily during study therapy
16324430|NCT00466102|Drug|Placebo|2 tablets are taken once daily during study therapy
16324431|NCT00466089|Drug|Erlotinib (Tarceva®)|Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
16324432|NCT00466076|Drug|Copaxone (Glatiramer acetate)|
16324433|NCT00466063|Drug|Deferasirox|
16324434|NCT00466037|Biological|Influenza vaccine|
16324435|NCT00466024|Behavioral|Health Coach and HEPA Air cleaners|Health Coach for ETS reduction in home and 2 HEPA air cleaners
16324436|NCT00466024|Behavioral|Health Coach and HEPA air cleaners|Behavioral training and 2 HEPA air cleaners
16324437|NCT00465985|Drug|ACZ885|
16324438|NCT00465985|Drug|Placebo|
16324592|NCT00464542|Drug|Metronidazole|500 mg, taken by mouth, two times a day, 7 days
16324439|NCT00465972|Drug|Doxepin|Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length
16324440|NCT00465972|Drug|Temazepam|Temazepam capsule 15 mg po nightly x duration of study
16324441|NCT00465972|Drug|Placebo|Placebo capsule nightly for duration of study
16324442|NCT00465959|Drug|trospium chloride inhalation powder (TrIP)|
16324443|NCT00465959|Drug|Placebo|
16324444|NCT00465946|Behavioral|Salt Supplementation|
16324445|NCT00465933|Drug|AIDA|
16324446|NCT00465920|Behavioral|modified cognitive behavioural therapy (mCBT)|
16324447|NCT00465907|Drug|Paclitaxel, Carboplatin and Irinotecan|Paclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks
16324448|NCT00465894|Drug|Extended Release Tolterodine LA|Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks
16324449|NCT00465894|Drug|Intra Vaginal Estradiol Cream|17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
16324450|NCT00465881|Device|CGM System for Type 1 and Type 2 Diabetes Mellitus|
16324451|NCT00465868|Procedure|PCI (percutaneous coronary intervention)|Outcome of PCI following AMI
16324452|NCT00465855|Combination Product|Hyperbaric Oxygen (HBO2) - 3 sessions|"Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
~For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods."
16324453|NCT00465855|Combination Product|Hyperbaric Oxygen (HBO2) - 1 session|"During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
~The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods."
16324454|NCT00465816|Biological|Nimenrix (Meningococcal vaccine 134612)|Single dose intramuscular injection
16324455|NCT00465816|Biological|Twinrix|3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
16324456|NCT00465803|Drug|Travoprost 0.004%/timolol 0.5% ophthalmic solution|One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
16324457|NCT00465803|Drug|Travoprost ophthalmic solution, 0.004%|One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
16324458|NCT00465803|Drug|Timolol maleate ophthalmic solution, 0.5%|One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid
16324459|NCT00465777|Behavioral|Guideline adherence and financial incentive|
16324460|NCT00465764|Other|Alternate protein infant formula|Feed as per HCP directions
16324461|NCT00465764|Other|Standard infant formula|Feed as per HCP directions
16324462|NCT00465751|Drug|chenodeoxycholic acid|chenodeoxycholic acid 500 mg capsules tid po
16324463|NCT00465751|Drug|placebo capsules|placebo capsules containing mannitol tid po
16324464|NCT00465738|Drug|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)"|active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
16324465|NCT00465725|Drug|Picoplatin|The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.
16324466|NCT00465712|Procedure|transabdominal amnioinfusion|transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
16324467|NCT00465699|Drug|Topical B12 0.07%|
16324468|NCT00465686|Device|ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)|ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions
16324469|NCT00465686|Device|ergonomic desk and chair (Q-Learn Desk)|child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
16324470|NCT00465673|Drug|Liposomal Doxorubicin|40mg/m2 over 1 hour infusion for 21 days
16324471|NCT00465660|Behavioral|Progressive resistance training|
16324472|NCT00465647|Drug|Hydromorphone|Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
16324473|NCT00465621|Drug|Xalatan|
16324474|NCT00465608|Drug|propranolol|propranolol by mouth (per os)
16324475|NCT00465595|Drug|psilocybin|The dose of psilocybin received in the two sessions will range anywhere from low to high.
16324476|NCT00465569|Drug|cow's milk powder|Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks
16324477|NCT00465569|Other|Placebo|
16324478|NCT00465556|Behavioral|Public Health Nurse Home Visit|The perinatal public health nurse home visit intervention also includes a trifold brochure, printed on 8X10 inch paper, with 6 panels, that can be read with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Participants will receive three prenatal and three postpartum sessions. The first prenatal sessions will be given during the first (enrollment), second, and third trimesters, with at least three weeks between sessions. Women entering the study after the first trimester will receive the initial session at enrollment, with two subsequent sessions spread out over the remainder of the scheduled prenatal home visitation program sessions.
16324593|NCT00464529|Device|Real-Time Continuous Glucose monitoring System (RT-CGMS)|
16324479|NCT00465556|Behavioral|Intimate Partner Violence (IPV) Protocol|The current protocol in use by the participating health departments when a women screens positive for intimate partner violence (IPV), current or history within the last year.
16324480|NCT00465543|Other|Mint tea high in rosmarinic acid|Mint tea high in rosmarininc acid contains 150mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
16324481|NCT00465543|Other|Mint tea low in rosmarinic acid|Mint tea low in rosmarininc acid contains 10mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
16324482|NCT00465530|Drug|Saline|Intranasal Saline
16324483|NCT00465530|Drug|Gentamycin|Intranasal irrigation
16324484|NCT00465517|Drug|Ganaxolone|Oral suspension 200-500 mg 3x/day
16324485|NCT00465517|Other|Placebo|non-active placebo
16324486|NCT00465504|Procedure|iontophoresis|See Detailed Description.
16324487|NCT00465491|Drug|picoplatin|IV picoplatin 150mg/m2 q3wk
16324488|NCT00465491|Other|best supportive care|best supportive care
16324489|NCT00465478|Procedure|Autologous bone marrow mononuclear cell transplantation|
16324490|NCT00465465|Biological|MVA 85A|i.d. injection
16324491|NCT00465452|Drug|Continuous Release Dopamine Agonists|Continuous Release Dopamine Agonists
16324492|NCT00465439|Drug|Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine|10 ml subcutaneously
16324493|NCT00465413|Device|Small volume spacer and/or Rinsing the mouth with water|
16324494|NCT00465387|Behavioral|Falls, Fractures & Osteoporosis Risk Assessment & Management|
16324495|NCT00465374|Procedure|Change ventilatory parameters with stress index monitoring|
16324496|NCT00465361|Procedure|performance feedback with an educational module|individual performance feedback with an educational module
16324497|NCT00465322|Drug|fluvastatin|
16324498|NCT00465309|Procedure|protective ventilation with CO2 removal technique|In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.
16324499|NCT00465296|Drug|rosiglitazone|
16324500|NCT00466388|Drug|Cevimeline|
16324501|NCT00465283|Drug|Donepezil|Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
16324502|NCT00465270|Device|AMPLATZER PFO Occluder|patent foramen ovale closure device
16324503|NCT00465270|Other|Standard of Care - Medical Management|Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
16324504|NCT00465257|Drug|artesunate + amodiaquine|
16324505|NCT00465244|Drug|Levetiracetam 1 g IV + Lorazepam 2 mg IV|Levetiracetam 1 g IV + Lorazepam 2 mg IV
16324506|NCT00465244|Drug|Placebo + Lorazepam 3 mg IV|Placebo + Lorazepam 3 mg IV
16324507|NCT00465231|Drug|bupivacaine, fentanyl|10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml
16324508|NCT00465231|Drug|preservative free saline|10mL saline solution
16324509|NCT00465218|Procedure|Prophylaxis of Thrombosis after aortic valve replacement|Two standard prophylactic treatments of thrombosis within the first 3 months postsurgery currently used in our institution: a) daily dose of aspirin (325 mgs; b) daily dose of aspirin (81 mg) plus Warfarin for target INR 2.0-2.5
16324510|NCT00465205|Drug|Valacyclovir|500mg oral twice daily
16324511|NCT00465205|Drug|Matching Placebo|500 mg oral twice daily
16324512|NCT00465192|Drug|estradiol, 10 mcg|
16324513|NCT00465192|Drug|estradiol, 25 mcg|
16324514|NCT00465192|Drug|placebo|
16324515|NCT00465179|Drug|Sunitinib Malate|50 mg by mouth daily for 4 weeks, then 2 weeks off.
16324516|NCT00465166|Procedure|Ultrasound|Lumbar ultrasound from L1-S1, carried out using a portable ultrasound system equipped with a 2-5 MHz curved array probe.
16324517|NCT00465153|Dietary Supplement|flax oil containing alpha linolenic acid|14g alpha linolenic acid per day
16324518|NCT00465153|Behavioral|Resistance exercise training|Resistance training
16324519|NCT00465140|Drug|creatine supplementation|
16324520|NCT00465140|Behavioral|aerobic exercise training|
16324521|NCT00465114|Procedure|Hemodynamic Monitoring|
16324522|NCT00465101|Device|GreenLight HPS|Greenlight HPS laser system for treatment of BPH
16324523|NCT00465088|Drug|Niacin ER/Simvastatin Tablets|Up to 2000 mg/40 mg at bedtime
16324524|NCT00465088|Drug|atorvastatin|40 mg at bedtime
16324525|NCT00465075|Drug|Bazedoxifene/conjugated estrogens combination|
16324526|NCT00465049|Other|PRIMARY CLOSRE|SUTURE
16324527|NCT00465049|Other|SECONDARY CLOSURE|ALLOW TO HEAL SPONTANEOUSLY
16324528|NCT00465049|Other|SPONTANEOUS HALING|SECONDARY HEALING AFTER I&D
16324529|NCT00465036|Dietary Supplement|Whole flaxseeds, flaxseed mucilage, glucomannan|
16324530|NCT00465023|Procedure|Proton Beam Radiation|Once a day, 5 days a week (Monday-Friday) for 3 weeks.
16324531|NCT00465010|Behavioral|Talking Parents, Healthy Teens|Talking Parents, Healthy Teens is a worksite-based parenting program to help parents of 6th-10th graders learn to promote their adolescents' healthy sexual development. The program is administered in 8 weekly one-hour sessions during the lunch hour to groups of about 15 parents and focuses on parent-adolescent relationships and communication, with an emphasis on promoting sexual health and reducing sexual risk. It is led by a trained facilitator and assistant facilitator.
16324532|NCT00464984|Behavioral|Lifestyle intervention|Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
16324533|NCT00464971|Drug|estradiol, 25 mcg|
16324534|NCT00464958|Drug|sublingual tizanidine 12 mg|Single sublingual tizanidine 12 mg tablet, to be administered once nightly, via sublingual administration for 12 months
16324535|NCT00464945|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 2,3,4 and 12 months of age
16324536|NCT00464932|Drug|Vasoactive Intestinal Peptide (VIP)|
16324537|NCT00464919|Drug|Sorafenib|
16324538|NCT00464919|Drug|tegafur/uracil (UFUR®)|
16324539|NCT00464893|Drug|Catumaxomab|10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
16324540|NCT00464893|Drug|catumaxomab|10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
16324542|NCT00464867|Biological|Whole cell killed cholera vaccine & probiotic|The oral cholera vaccine Dukoral will be administered to all study participants in two doses,two weeks between doses.Each dose of the formalin inactivated whole cell vaccine contains one mg of recombinant B subunit of cholera toxin(rCTB).The vaccine will be administered in bicarbonate-tartaric acid buffer to counteract the effect of low pH in the stomach.
16324543|NCT00464854|Drug|Glargine and insulin aspart or lispro|
16324544|NCT00464841|Procedure|Combined spinal epidural|0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
16324545|NCT00464841|Procedure|Tsui Test for intrathecal catheter|0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
16324546|NCT00464828|Procedure|Internal jugular vein cannulation|
16324547|NCT00464828|Device|ultrasound|
16324548|NCT00464815|Biological|Meningococcal vaccine GSK134612|One intramuscular dose
16324549|NCT00464815|Biological|Mencevax™ ACWY|One subcutaneous dose
16324550|NCT00464802|Drug|MOA-728|
16324551|NCT00464789|Drug|Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet|
16324552|NCT00464776|Drug|Aliskiren|
16324553|NCT00464776|Drug|Aliskiren|
16324554|NCT00464776|Drug|Aliskiren|
16324555|NCT00464776|Drug|Aliskiren|
16324556|NCT00464763|Drug|Dexmedetomidine|
16324557|NCT00464763|Drug|Placebo|
16324558|NCT00464750|Device|Pulmonary artery catheter|Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.
16324559|NCT00464737|Drug|Rotigotine|Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)
16324560|NCT00464737|Drug|Rotigotine|Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)
16324561|NCT00464737|Other|Placebo|Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
16324562|NCT00464724|Procedure|3T Magnetic Resonance Spectroscopic Imaging|Part 1 of Study = One MRSI exam with an air-filled endorectal coil (AIR-MRSI) and one with a PFC-filled endorectal coil (PFC-MRSI); Part 2 of Study = MRSI exam with PFC using an endorectal coil only.
16324563|NCT00464711|Drug|Escitalopram|Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
16324564|NCT00464698|Drug|Duloxetine|Participants received increasing amounts of Duloxetine for 7 weeks.
16324565|NCT00464685|Drug|Dexamethasone|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
16324566|NCT00464685|Drug|Sham injection|Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
16324567|NCT00464685|Procedure|Laser Photocoagulation|Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
16324568|NCT00464672|Biological|Influenza virus vaccine|Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
16324569|NCT00464672|Biological|Comparator influenza vaccine|Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
16324570|NCT00464659|Device|Effective CPAP|Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water
16324571|NCT00464659|Device|Sham CPAP|Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
16324577|NCT00464633|Drug|alvocidib|"1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion
~Then, every treatment week, depending upon the patient's objective response to initial therapy:
~30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or
~30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours."
16324578|NCT00464620|Drug|Dasatinib|oral agent, continuous dosing, Cycles = 28 days
16324579|NCT00464607|Drug|hMG-IBSA|
16324580|NCT00464607|Procedure|Ovarian stimulation|
16324581|NCT00464594|Behavioral|Standard lifestyle guidance|
16324582|NCT00464594|Drug|Lifestyle guidance and monotherapy with acarbose|
16324583|NCT00464594|Drug|Lifestyle guidance and monotherapy with metformin|
16324584|NCT00464594|Drug|Lifestyle guidance and monotherapy with gliclazide|
16324585|NCT00464568|Drug|GSK256066|
16324586|NCT00464555|Procedure|Islet transplant|Transplantation of pancreatic islet cells
16324587|NCT00464555|Drug|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
16324588|NCT00464555|Drug|Basiliximab|Will replace antithymocyte globulin in all islet transplantations after the first one
16324589|NCT00464555|Drug|Lisofylline|An anti-inflammatory that may reduce the rate at which islet cells die.
16324590|NCT00464555|Drug|Sirolimus|Maintenance immunosuppressive therapy
16324591|NCT00464555|Drug|Tacrolimus|Maintenance immunosuppressive therapy
16324594|NCT00464516|Drug|placebo|once daily for 14 days orally
16324595|NCT00464516|Drug|Estetrol|once daily for 14 days orally
16324596|NCT00464503|Drug|Rosuvastatin-Crestor|
16324597|NCT00464503|Drug|Pravastatin-Pravasine|
16324598|NCT00464490|Drug|Dexmedetomidine|Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine will be titrated according to blood pressure, RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced.
16324599|NCT00464464|Behavioral|cognitive-behavioral therapy|The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.
16324600|NCT00464451|Drug|Dexmedetomidine|Dexmedetomidine 3 micrograms per kilogram per os; subsequent dose of 1 microgram per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
16324601|NCT00464451|Drug|Chloral hydrate|Chloral hydrate 75 milligrams per kilogram per os; subsequent dose of 25 milligrams per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
16324602|NCT00464438|Drug|gatifloxacin|Day 1-6 = 1 drop of study medication three times a day
16324603|NCT00464438|Drug|moxifloxacin 0.5% eye drops|Day 1-6 = 1 drop of study medication three times a day
16324604|NCT00464425|Procedure|Electroacupuncture|EA using sharp needles placed at various acupoints; electrical stimulation at 50 Hz applied to the needles
16324605|NCT00464425|Procedure|Sham Acupuncture|Acupuncture using blunt-tip needles placed 15 mm away from acupoints; no electrical stimulation used
16324606|NCT00464425|Other|No Acupuncture|Control
16324607|NCT00464412|Behavioral|Education|
16324608|NCT00464399|Drug|everolimus|
16324609|NCT00464386|Device|Continuous Glucose Monitoring|measure glucose levels on burn patients
16324610|NCT00464373|Drug|Botulinum Toxin Type A|Single intrasphincteric injection at the 3,6,9, and 12 o'clock positions of the external urethral sphincter (1 ml of drug solution each)
16324611|NCT00464373|Drug|Placebo|4ml NaCl 0.9%
16324612|NCT00464347|Drug|Avastin|
16324613|NCT00464347|Procedure|Photodynamic Therapy (PDT)|
16324614|NCT00464347|Drug|Preservative-Free Triamcinolone Acetonide (TAC-PF)|
16324615|NCT00464334|Biological|V950|V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
16324616|NCT00464334|Biological|ISCOMATRIX™|ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
16324617|NCT00464334|Biological|Placebo to V950|
16324618|NCT00464321|Biological|GC1008|1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
16324619|NCT00464321|Biological|GC1008|2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
16324620|NCT00464321|Biological|GC1008|4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
16324621|NCT00464321|Biological|GC1008|0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
16324622|NCT00464308|Drug|Esomeprazole|20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
16324623|NCT00464308|Drug|Rabeprazole|20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
16324624|NCT00464308|Drug|Esomeprazole|40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
16324625|NCT00464295|Drug|Capecitabine in HCC|
16324626|NCT00464269|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Film-coated tablet
~Concentration: 2.5 mg, 10 mg and 25 mg
~Route of Administration: Oral use"
16324627|NCT00464269|Drug|Brivaracetam 2.5 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 2.5 mg
~Route of Administration: Oral use"
16324628|NCT00464269|Drug|Brivaracetam 10 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 10 mg
~Route of Administration: Oral use"
16324629|NCT00464269|Drug|Brivaracetam 25 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
16324630|NCT00464256|Drug|rimonabant|
16324631|NCT00464243|Drug|volinanserin|oral administration
16324632|NCT00464243|Drug|placebo|oral administration
16324633|NCT00464230|Procedure|Bipolar hemiarthroplasty (Charnley/Hastings)|
16324634|NCT00464230|Procedure|Internal fixation with two parallel screws (Olmed)|
16324635|NCT00464217|Drug|ARA-C|
16324636|NCT00464217|Drug|Idarubicin|
16324637|NCT00464217|Drug|Leucomax|
16324638|NCT00464204|Drug|"6 % Hydroxyethylstarch 130/0.4 = Voluven®"|Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.
16324639|NCT00464204|Drug|0.9 % NaCl|NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
16324640|NCT00464191|Drug|escitalopram|
16324641|NCT00464178|Drug|Bortezomilb|Bortezomilb will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.
16324642|NCT00464165|Drug|rimonabant|
16324643|NCT00464139|Procedure|Laparoscopy|Laparoscopy
16324644|NCT00464126|Other|5% albumin|5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
16324645|NCT00464126|Other|crystalloid|saline in 10cc/kg aliquots for postoperative volume resuscitation
16324646|NCT00464113|Drug|XL228|1-hour IV infusion
16324647|NCT00464087|Drug|Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin|
16324648|NCT00464061|Drug|Volinanserin|oral administration
16324649|NCT00464061|Drug|Placebo|oral administration
16324650|NCT00464048|Procedure|controlled physical exercise|
16324651|NCT00464035|Behavioral|high calcium intake|
16324652|NCT00464022|Device|Carbon dioxide|
16324708|NCT00463567|Drug|Placebo to Indacaterol|In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
16324709|NCT00463567|Drug|Placebo to Formoterol|In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
16324653|NCT00464009|Behavioral|Continuing medical education|"Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using learning collaborative methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist."
16324654|NCT00463983|Drug|octreotide|
16324655|NCT00463970|Behavioral|Brief Intervention|Physical examination, education and follow up by a physiotherapist
16324656|NCT00463970|Behavioral|Cognitive Behavioural Therapy|7 sessions of CBT over a period of 2 months, included a booster session after 3 months
16324657|NCT00463970|Dietary Supplement|Seal oil|20 capsules per day for 3 months
16324658|NCT00463970|Dietary Supplement|Soy oil|20 capsules per day for 3 months
16324659|NCT00463957|Drug|sildenafil|
16324660|NCT00463957|Drug|tadalafil|
16324661|NCT00463957|Drug|placebo|
16324662|NCT00463944|Behavioral|Effect of an electronic voting system|
16324663|NCT00463918|Drug|varenicline|
16324664|NCT00463905|Procedure|Clinical assessment +/- radiography|Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance
16324665|NCT00463892|Procedure|High-resolution contrast-enhanced MRI scan|High-resolution contrast-enhanced MRI scan of regional lymph nodes every 6 months on study
16324666|NCT00463879|Drug|Galantamine|
16324667|NCT00463866|Drug|Budesonide/formoterol|
16324668|NCT00463853|Procedure|Autologous stem cell therapy|
16324669|NCT00463853|Procedure|CABG|
16324670|NCT00463853|Radiation|CMRI|
16324671|NCT00463840|Drug|Oxaliplatin|
16324672|NCT00463840|Drug|5FU|
16324673|NCT00463840|Radiation|Radiation|
16324674|NCT00463840|Procedure|Surgery|
16324675|NCT00463840|Drug|FOLFOX 6|this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin
16324676|NCT00463827|Drug|Atorvastatin|
16324677|NCT00463827|Drug|atorvastatin|atorvastatin 40mg
16324678|NCT00463827|Drug|matched placebo|Matched placebo
16324679|NCT00463814|Drug|AZD6244|oral capsule
16324680|NCT00463801|Drug|Daptomycin|
16324681|NCT00463788|Drug|cetuximab, cisplatin|"Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m^2) followed by weekly doses of 250 mg/m^2. All doses will be given by intravenous (IV) infusion.
~Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
~Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent."
16324682|NCT00463788|Drug|cisplatin|"Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.
~Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles.
~Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent."
16324683|NCT00463775|Drug|Topiramate|SSRI plus topiramate SSRI plus placebo
16324684|NCT00463762|Drug|CP-75385-02 Cefoperazone/sulbactam|
16324685|NCT00463749|Drug|Acetylcystein|high-dose N-Acetylcystein during PCI and for 2/day for 2 days
16324686|NCT00463749|Drug|Placebo|NaCl as placebo
16324687|NCT00463736|Drug|Magnesium sulfate|
16324688|NCT00463723|Drug|FK506 0.06% (eye drops)|
16324689|NCT00463710|Drug|Avonex® monotherapy (6.0 MIU administered i.m. each week)|
16324690|NCT00463697|Drug|GW642444H (100mcg)|H salt
16324691|NCT00463697|Drug|placebo|placebo
16324692|NCT00463697|Drug|GW642444M (25, 100 & 400 mcg)|M salt
16324693|NCT00463684|Biological|Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine|Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.
16324694|NCT00463684|Biological|Live, attenuated measles vaccine|Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.
16324695|NCT00463671|Drug|N-acetylcysteine|
16324696|NCT00463658|Other|Falls Prevention|Subjects in the interdisciplinary group will receive home care services from a team of professional service providers (CCAC Case Manager, Public Health Nurse (Registered Nurse), Occupational Therapist, Physiotherapist, Nutritionist) with experience and training in falls prevention. The team will provide a comprehensive, coordinated and evidence based approach to falls prevention through weekly case conferencing, a written interdisciplinary care plan, and joint client visits.
16324697|NCT00463645|Procedure|microdialysis|
16324698|NCT00463645|Procedure|microperfusion|
16324699|NCT00463619|Drug|Retarded release phosphatidylcholine|2g phosphatidylcholine, given QTD
16324700|NCT00463606|Drug|ABT-335 and rosuvastatin calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
16324701|NCT00463606|Drug|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
16324702|NCT00463606|Drug|rosuvastatin calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
16324703|NCT00463580|Drug|Infliximab|Participants will receive three infusions 5mg/kg of infliximab (at Baseline, Week 2 and Week 6)
16324704|NCT00463580|Drug|Placebo|Participants will receive three infusions of a placebo (at Baseline, Week 2 and Week 6)
16324705|NCT00463567|Drug|Indacaterol|In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
16324706|NCT00463567|Drug|Formoterol (12 µg b.i.d.)|Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
16324707|NCT00463567|Drug|Tiotropium (18 µg o.d.)|Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
16324710|NCT00463554|Device|GYNECARE TVT-SECUR* System|A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency
16324711|NCT00463541|Drug|solifenacin succinate|oral
16324712|NCT00463515|Drug|carboplatin/gemcitabine|
16324713|NCT00463515|Procedure|cisplatin/radiation therapy|
16324714|NCT00463502|Drug|Metformin|
16324715|NCT00463489|Behavioral|Lifestyle intervention|Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.
16324716|NCT00463489|Behavioral|Mail-based|Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.
16324717|NCT00463476|Biological|Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV)|Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right upper arm using 23 gauge needles.
16324718|NCT00463463|Drug|90Yttrium Ibritumomab Tiuxetan (Zevalin)|
16324719|NCT00463450|Drug|Gynodian® Depot (BAY86-5032)|Injection monthly
16324720|NCT00463450|Drug|BAY86-4980|orally
16324721|NCT00463437|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 1 dose.
16324722|NCT00463437|Biological|Prevenar|Intramuscular injection, 1 dose.
16324723|NCT00463437|Biological|Infanrix hexa|Intramuscular injection, 1 dose. In Germany and Poland.
16324724|NCT00463437|Biological|Infanrix IPV Hib|Intramuscular injection, 1 dose. In Spain.
16324725|NCT00463437|Biological|Infanrix penta|Intramuscular injection, 1 dose. In Germany and Poland.
16324726|NCT00463437|Biological|Infanrix IPV|Intramuscular injection, 1 dose. In Spain.
16324727|NCT00463437|Biological|Meningitec|Intramuscular injection, 1 dose.
16324728|NCT00463437|Biological|NeisVac-C|Intramuscular injection, 1 dose.
16324729|NCT00463437|Biological|Menitorix|Intramuscular injection, 1 dose.
16324730|NCT00463424|Device|NeuFlex metacarpophalangeal implant|
16324731|NCT00463424|Device|Swanson metacarpophalangeal implant|
16324732|NCT00463385|Drug|Pomalidomide|
16324733|NCT00463385|Drug|Prednisone|Participants will take oral prednisone in the evening for 3 cycles of 28 days each (up to 84 days). The dose will be as follows: 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day.
16324734|NCT00463385|Drug|Placebo to pomalidomide|Matching pomalidomide placebo tablets
16324735|NCT00463385|Drug|Placebo to prednisone|Matching prednisone placebo tablets
16324736|NCT00463372|Drug|PF-02545920|
16324737|NCT00463359|Drug|Imiquimod cream|
16324738|NCT00463359|Procedure|curettage and cautery|
16324739|NCT00463346|Drug|Acamprosate|Acamprosate 1998 mg tid
16324740|NCT00463346|Drug|Placebo|Placebo
16324741|NCT00463320|Drug|Pazopanib eye drops and Allergen Refresh Plus eye drops|
16324742|NCT00463294|Procedure|Coronary Artery Bypass Graft with the use of CPB|Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures
16324743|NCT00463294|Procedure|Coronary Artery Bypass Graft without the use of CPB|Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia
16324744|NCT00463268|Drug|alendronate|alendronate 70 mg every 2 weeks
16324745|NCT00463268|Dietary Supplement|Calcium/Vitamin D|Calcium 500 mg and vitamin D supplementation according to serum level
16324746|NCT00463268|Drug|placebo|identical placebo every 2 weeks
16324747|NCT00463255|Behavioral|diet|
16324748|NCT00463242|Drug|Agomelatine|Either 25 mg or 50 mg agomelatine orally once daily
16324749|NCT00463242|Drug|paroxetine|
16324750|NCT00463242|Drug|placebo|
16324751|NCT00463229|Other|Interprofessional Team Approach|Subject in the second group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
16324752|NCT00463216|Behavioral|A multidisciplinary diagnostic evaluation|
16324753|NCT00463203|Drug|Bevacizumab|10 mg/kg every 2 weeks
16324754|NCT00463203|Drug|Irinotecan|125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks
16324755|NCT00463190|Drug|Biothree|
16324756|NCT00463151|Drug|rebamipide|0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
16324757|NCT00463138|Behavioral|Crisis intervention|
16324758|NCT00463125|Drug|Platelet Gel|
16324759|NCT00463112|Drug|Sibutramine|
16324760|NCT00463086|Drug|isoniazid|A self-administered daily dose of 5mg/kg of Isoniazid or placebo for 12months(300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)
16324761|NCT00463086|Drug|Placebo|A self-administered dose of 5mg/kg of placebo (300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)
16324762|NCT00463073|Drug|Cetuximab|
16324763|NCT00463073|Drug|Bevacizumab|
16324764|NCT00463073|Drug|Irinotecan|
16324765|NCT00463060|Drug|sunitinib malate (Sutent)|Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43.
16324766|NCT00463060|Procedure|radiotherapy|Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated
16324816|NCT00462735|Drug|Cetuximab|250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
16324890|NCT00462332|Drug|Campath|Post-induction therapy
16324767|NCT00463047|Drug|Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone|Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.
16324768|NCT00463034|Genetic|microarray analysis|
16324769|NCT00463034|Genetic|polymerase chain reaction|
16324770|NCT00463034|Genetic|polymorphism analysis|
16324771|NCT00463034|Other|high performance liquid chromatography|
16324772|NCT00463034|Other|immunohistochemistry staining method|
16324773|NCT00463034|Other|laboratory biomarker analysis|
16324774|NCT00463034|Other|questionnaire administration|
16324775|NCT00463021|Drug|Hectorol (doxercalciferol capsules)|
16324776|NCT00463021|Drug|Zemplar (paricalcitol injection)|
16324777|NCT00463008|Drug|methotrexate|
16324778|NCT00463008|Other|pharmacological study|
16324779|NCT00462995|Drug|Erlotinib|150mg once a day for 28 days
16324780|NCT00462995|Drug|Erlotinib|28 days of Erlotinib before surgery in patients with stage I-IIb NSCLC
16324781|NCT00462982|Drug|sunitinib malate|
16324782|NCT00462969|Procedure|Sonohysterography|Sonohysterography
16324783|NCT00462956|Drug|Tykerb|lapatinib 1500mg daily
16324784|NCT00462943|Drug|Omacetaxine mepesuccinate|"Induction: 1.25mg/m^2 subcutaneously twice daily for 14 consecutive days, every 28 days.
~Maintenance: 1.25mg/m^2 subcutaneously twice daily for 7 consecutive days, every 28 days.
~Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study."
16324785|NCT00462917|Behavioral|Pleiotropic info, in-person disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
~Genetic counselors communicate results to participants during an in-person disclosure session."
16324786|NCT00462917|Behavioral|AD-only info, in-person disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
~Genetic counselors communicate results to participants during an in-person disclosure session."
16324787|NCT00462917|Behavioral|Pleiotropic info, phone disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
~Genetic counselors communicate results to participants during a telephone disclosure session."
16324788|NCT00462917|Behavioral|AD-only info, phone disclosure|"Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
~Genetic counselors communicate results to participants during an in-person disclosure session."
16324789|NCT00462904|Drug|BPI|BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
16324790|NCT00462891|Other|IT System|
16324791|NCT00462878|Drug|Meropenem|antibiotic
16324792|NCT00462878|Drug|Vancomycin|Antibiotic
16324793|NCT00462878|Drug|Teicoplanin|Antibiotic
16324794|NCT00462865|Drug|Gemcitabine and Capecitabine and Avastin|avastin administered concurrently with chemotherapy (gemcitabine + capecitabine) for six cycles followed by single agent avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.
16324795|NCT00462852|Drug|dalteparin|
16324796|NCT00462852|Drug|gemcitabine hydrochloride|
16324797|NCT00462852|Other|diagnostic laboratory biomarker analysis|
16324798|NCT00462839|Procedure|blood loss estimation|Participants were randomized in blocks, by provider type to view either the four calibrated stations or the four non-calibrated stations. The order of the volumes within each set of stations was randomized. Participants received a data card for each station on which they wrote the volume estimated. After each station, the data card was collected. Alterations to the estimations were not allowed once the answers were recorded. Subjects were then crossed over to the other group and asked to estimate the blood volumes in the non-calibrated drapes if they had first viewed the calibrated drape or the calibrated drape if they had viewed the non-calibrated drape. The order of viewing the four volumes was again randomized. The volumes were the same at the corresponding station for the calibrated and non-calibrated stations so the impact of the calibration markings on accuracy could be determined.
16324799|NCT00462826|Biological|ziv-aflibercept|
16324800|NCT00462813|Drug|oral microencapsulated diindolylmethane|
16324801|NCT00462813|Genetic|polymerase chain reaction|
16324802|NCT00462813|Other|cervical Papanicolaou test|
16324803|NCT00462813|Other|cytology specimen collection procedure|
16324804|NCT00462813|Procedure|colposcopic biopsy|
16324805|NCT00462787|Biological|filgrastim|
16324806|NCT00462787|Drug|clofarabine|
16324807|NCT00462787|Drug|dexamethasone|
16324808|NCT00462787|Drug|thiotepa|
16324809|NCT00462787|Drug|topotecan hydrochloride|
16324810|NCT00462787|Drug|vinorelbine tartrate|
16324811|NCT00462774|Procedure|Intramyocardial injection of autologous CD133+ marrow cells|
16324812|NCT00462761|Drug|AC220|Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.
16324813|NCT00462748|Drug|ezetimibe (+) simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
16324814|NCT00462748|Drug|Comparator: atorvastatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
16324815|NCT00462748|Drug|Comparator: rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
16325061|NCT00460785|Drug|Opioid|
16324817|NCT00462735|Drug|Hydroxyurea|500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
16324818|NCT00462735|Drug|Fluorouracil|continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
16324819|NCT00462735|Procedure|radiotherapy|"Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.
~Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients."
16324820|NCT00462722|Drug|Ibuprofen|400 mg with each exercise session (up to 5 days per week) for 9 months
16324821|NCT00462722|Drug|Placebo|with each exercise session (up to 5 days per week) for 9 months
16324822|NCT00462722|Behavioral|musculoskeletal-loading exercise|Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months
16324823|NCT00462709|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
16324824|NCT00462696|Drug|docetaxel|
16324825|NCT00462696|Drug|epirubicin hydrochloride|
16324826|NCT00462696|Procedure|conventional surgery|
16324827|NCT00462696|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16324828|NCT00462696|Procedure|neoadjuvant therapy|
16324829|NCT00462696|Procedure|radiomammography|
16324830|NCT00462670|Drug|OPC-41061(Tolvaptan)|0, 15mg of OPC-41061 per day for 7days p.o. administration
16324831|NCT00462657|Genetic|polymerase chain reaction|
16324832|NCT00462657|Other|bronchoalveolar lavage|
16324833|NCT00462657|Other|immunoenzyme technique|
16324834|NCT00462657|Other|laboratory biomarker analysis|
16324835|NCT00462657|Procedure|bronchoscopy|
16324836|NCT00462657|Procedure|management of therapy complications|
16324837|NCT00462644|Drug|RSI sedation with etomidate/succinylcholine|etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
16324838|NCT00462644|Drug|RSI sedation with fentanyl/midazolam/succinylcholine|100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV
16324839|NCT00462631|Device|Paclitaxel Eluting Balloon|Paclitaxel eluting balloon
16324840|NCT00462631|Device|paclitaxel eluting stent|paclitaxel eluting stent
16324841|NCT00462631|Device|bare metal stent|bare metal stent
16324842|NCT00462618|Drug|Quetiapine|
16324843|NCT00462618|Behavioral|Cogntive behavioral therapy|
16324844|NCT00462605|Drug|entinostat|Given PO
16324845|NCT00462605|Drug|sargramostim|Given SC
16324846|NCT00462592|Drug|budesonide|inhaled budesonide turbuhaler 200ug taken 1 puff morning & 1 puff evening.
16324847|NCT00462592|Drug|montelukast|montelukast 5 mg ( < 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening
16324848|NCT00462592|Other|placebo|placebo
16324849|NCT00462566|Device|motor cortex stimulation|
16324850|NCT00462553|Drug|sunitinib malate|Given orally
16324851|NCT00462553|Drug|gemcitabine hydrochloride|Given IV
16324852|NCT00462540|Drug|Formoterol Fumurate inhalation solution 20 mcg|
16324853|NCT00462540|Drug|Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg|
16324854|NCT00462501|Biological|bevacizumab|
16324855|NCT00462501|Drug|fluorouracil|
16324856|NCT00462501|Drug|leucovorin calcium|
16324857|NCT00462501|Drug|oxaliplatin|
16324858|NCT00462501|Procedure|conventional surgery|
16324859|NCT00462501|Radiation|radiation therapy|
16324860|NCT00462488|Drug|Vicinium|Intravesical administration of Vicinium
16324861|NCT00462475|Drug|Recombinant Growth Hormone, Genotropin (Pfizer)|
16324862|NCT00462462|Drug|Ethanol 96% Gel|
16324863|NCT00462462|Drug|Ethanol 98% Solution|
16324864|NCT00462449|Device|Functional Electrical Stimulation (FES) through the Ness H200|Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
16324865|NCT00462436|Behavioral|Consumption of Dietary Portfolio|The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.
16324866|NCT00462423|Drug|Avastin|Avastin 10 mg/kg IV every 2 weeks (without rest period).
16324867|NCT00462423|Drug|Abraxane|Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle.
16324868|NCT00462410|Other|counseling intervention|
16324869|NCT00462410|Procedure|psychosocial assessment and care|
16324870|NCT00462397|Drug|carboplatin|
16324871|NCT00462397|Drug|cisplatin|
16324872|NCT00462397|Drug|paclitaxel|
16324873|NCT00462397|Procedure|neoadjuvant therapy|
16324874|NCT00462397|Radiation|brachytherapy|
16324875|NCT00462397|Radiation|radiation therapy|
16324876|NCT00462384|Drug|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
16324877|NCT00462371|Device|Insulin pump (CSII)|
16324878|NCT00462358|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
16324879|NCT00462358|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|Part 1: standard of care; Part 2: standard of care.
16324880|NCT00462345|Drug|rituximab|1000 mg i.v. on Days 1 and 15
16324881|NCT00462345|Drug|Methotrexate|10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24
16324882|NCT00462345|Drug|Corticosteroid or NSAID|≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24
16324883|NCT00462345|Dietary Supplement|Folate|≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24
16324884|NCT00462332|Drug|Fludarabine|Induction therapy
16324885|NCT00462332|Drug|Campath|Induction therapy
16324886|NCT00462332|Procedure|Transplant|Post-induction therapy
16324887|NCT00462332|Drug|Campath|Post-induction therapy
16324888|NCT00462332|Drug|Fludarabine|Induction therapy
16324889|NCT00462332|Drug|Campath|Induction therapy
16324891|NCT00462319|Behavioral|Education, weight reduction and physical exercise|
16324892|NCT00462306|Procedure|Survey: Berlin questionnaire|Completion of questionnaire
16324893|NCT00462280|Drug|lovastatin|Given PO
16324894|NCT00462280|Other|placebo|Given PO
16324895|NCT00462280|Procedure|biopsy|Correlative studies
16324896|NCT00462280|Procedure|laboratory biomarker analysis|Correlative studies
16324897|NCT00462267|Behavioral|Enriched lifestyle intervention|Multi-component lifestyle intervention
16324898|NCT00462254|Drug|ROZEREM|8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
16324899|NCT00462254|Drug|Ramelteon|8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
16324900|NCT00462241|Procedure|chiropractic treatment|Participants in the therapy group undergo a physical examination by an experienced, primary sector chiropractor, lasting up to one hour. The chiropractors choose an individual treatment strategy based on a combination of their findings, the patient history, and a standardized protocol reflecting routine practice. The standardized treatment protocol includes high velocity, low amplitude manipulation directed towards the thoracic and/or cervical spine in combination with any of the following: Joint mobilisation, soft tissue techniques, stretching, stabilising or strengthening exercises, heat or cold treatment, and advice. The protocol specifies up to ten treatment sessions of approximately 20 minutes, 1-3 times per week, or treatment until the patient is pain free. The chiropractors record the types of treatment rendered at sessions.
16324901|NCT00462241|Other|Self-management|Advice group: Advice is directed towards promoting self-management. The participants are told that their chest pain generally has a benign, self limiting course. The participants receive individual instructions regarding posture and two or three exercises aiming to increase spinal or muscle stretch based on clinical evaluation. They are advised to seek medical attention for re-evaluation (general physician, chest pain clinic or emergency department) in case of severe or unfamiliar chest pain. The session lasts on average 15 minutes. Further, the advice group is also asked not to seek any manual treatment for the next four weeks.
16324902|NCT00462228|Drug|Memantine|After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.
16324903|NCT00462228|Drug|Placebo|After randomization of the subject, subjects will be titrated up to 20 mg of memantine or placebo per day. Memantine and placebo are provided as 5 mg tablets. Subjects will be started at 5 mg per day. The dose will be increased by 5 mg increments to 10 mg per day (5 mg twice per day), 15 mg per day (5 mg and 10 mg as separate doses) and 20 mg per day (10 mg twice per day). The minimum interval between dose increases will be one week. Subjects will take memantine or placebo for 12 weeks during each part of the crossover study. Subjects are randomized to begin either memantine or placebo in each arm of the study.
16324904|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004
16324905|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004
16324906|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005
16324907|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005
16324908|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
16324909|NCT00462215|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
16324910|NCT00462202|Drug|sulodexide|
16324911|NCT00462189|Drug|Immunotoxin therapy|
16324912|NCT00462189|Drug|CAT-8015 Immunotoxin|
16324913|NCT00462189|Procedure|Biological therapy|
16324914|NCT00462176|Procedure|multidisciplinary laparoscopy|Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.
16324915|NCT00462176|Other|Questionnaires|All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
16324916|NCT00462150|Behavioral|home-based emotional disclosure|
16324917|NCT00462150|Behavioral|time management control condition|
16324918|NCT00462137|Procedure|Sleep Studies|
16324919|NCT00462124|Device|Absorbable perirectal spacer|biodegradable balloon implant to increase the distance between prostate and anterior rectal wall
16324920|NCT00462111|Drug|Indometacin|
16325062|NCT00460759|Drug|Moxifloxacin|
16324921|NCT00462098|Device|hyperbaric oxygen|40 sessions of 100% oxygen at 2 atmospheres of pressure for 2 hours each
16324922|NCT00462098|Device|non-treated control group|no change from routine care, no HBO
16324923|NCT00462072|Drug|Infliximab|Subjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg.
16324924|NCT00462059|Behavioral|Treatment|
16324925|NCT00462046|Drug|Berberine|
16324926|NCT00462020|Drug|5 days of IV antibiotics (ceftriaxone and metronidazole)|5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)
16324927|NCT00462020|Drug|Home with oral antibiotics when eating (ampicillin/clavulanic acid)|Augmentin 40mg/kg BID when tolerating POs to complete 7 days total
16324928|NCT00462007|Drug|Stalevo|Oral 3-4 daily doses for 6 weeks
16324929|NCT00461994|Behavioral|diet|
16324930|NCT00461994|Behavioral|exercise|
16324931|NCT00461994|Behavioral|diet and exercise|
16324932|NCT00461981|Biological|TIV, Trivalent Inactivated Influenza Virus Vaccine|0.25 mL will be administered intramuscularly for each of two doses
16324933|NCT00461981|Biological|FluMist, Influenza Virus Vaccine Live|0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
16324934|NCT00461968|Drug|Ezetimibe and Simvastatin|
16324935|NCT00461955|Procedure|autologous peripheral blood stem cell transplantation, ex vivo amplified|autologous peripheral blood stem cell transplantation, ex vivo amplified
16324936|NCT00461942|Drug|Green Tea Polyphenols (EGCG/ECG)|
16324937|NCT00461929|Procedure|bone marrow aspiration|
16324938|NCT00461916|Drug|Half-Dose Depot Triptorelin|
16324939|NCT00461916|Drug|Reduced-Dose Daily Buserelin|
16324940|NCT00461903|Drug|Perindopril|Perindopril 4 mg or matching placebo , 1 tablet administrated once daily for the first 2 weeks. If tolarable, dosage increased to 8mg/day until the end of the study (
16324941|NCT00461890|Drug|Injectable Naltrexone|
16324942|NCT00461864|Procedure|ultrasound examination of the hip|
16324943|NCT00461851|Drug|Gemcitabine|Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
16324944|NCT00461851|Drug|Carboplatin|Carboplatin will be given on day 1 to an AUC of 5.
16324945|NCT00461851|Drug|Sorafenib|Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
16324946|NCT00461838|Procedure|multidisciplinary laparoscopy|Multidisciplinary (with active involvement of the colorectal surgeon/urologist) fertility-sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis.
16324947|NCT00461838|Other|Questionnaires|Patients (n=56) were asked to complete questionnaires regarding quality of life (QOL), pain, fertility and sexuality to compare their status before and after surgery, and their medical files were analyzed.
16324948|NCT00461825|Drug|Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups|
16324949|NCT00461825|Drug|Group A: CsA + Azathioprine(1 to 2 mg/kg/day)|
16324950|NCT00461825|Drug|Group B: CsA + CellCept(500 mg x 2/day)|
16324951|NCT00461825|Drug|Group C: CsAm|
16324952|NCT00461812|Drug|Mometasone|
16324953|NCT00461812|Drug|Advair|
16324954|NCT00461799|Drug|orlistat|
16324955|NCT00461786|Drug|pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
16324956|NCT00461773|Drug|Letrozole|Letrozole 2.5 mg po qd
16324957|NCT00461773|Drug|Bevacizumab|bevacizumab 10 mg/kg IV
16324958|NCT00461760|Procedure|Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive|See Detailed Description.
16324959|NCT00461760|Procedure|Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive|See detailed description.
16324960|NCT00461747|Drug|VBMCP/VBAD/Velcade|"VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.
~VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20."
16324961|NCT00461747|Drug|Thalidomide/Dexamethasone|"Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.
~Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days"
16324962|NCT00461747|Drug|Velcade/Thalidomide/Dexamethasone|"Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.
~Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.
~Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days"
16324963|NCT00461734|Other|RV lead placement site|Patients randomised to RV apical or high septal lead placement site
16324964|NCT00461708|Drug|Erlotinib|100 mg, PO, once per day
16324965|NCT00461708|Drug|Gemcitabine|1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
16324966|NCT00461695|Biological|Vaccination against TBEV (FSME Immun CC)|Intramuscular injection into the left (or right) deltoid muscle of 0.5 ml FSME Immun CC for adults (2.4 ug of formalin inactivated TBEV antigen) at time point 0, after 4 weeks and after 24 weeks.
16324967|NCT00461682|Drug|SB-705498|
16324968|NCT00461669|Procedure|ultrasound examination of the hip|
16324969|NCT00461656|Drug|Preoperative conjunctival irrigation with 5% or 1.25% PI|Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%
16324970|NCT00461643|Drug|Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins|
16324971|NCT00461630|Drug|ER niacin/laropiprant|
16324972|NCT00461630|Drug|simvastatin|40 mg simvastatin tablet orally per day as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level
16324973|NCT00461630|Drug|ezetimibe/simvastatin|10 mg ezetimibe plus 40 mg simvastatin in single tablet taken once daily as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level
16324974|NCT00461617|Drug|Mitiglinide|10mg tablet, 10mg TID
16324975|NCT00461591|Drug|Apaziquone|A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
16324976|NCT00461591|Drug|Placebo|A single intravesical dose of placebo instilled into the bladder post-TURBT
16324977|NCT00461591|Procedure|TURBT|TransUrethral Resection of the Bladder Tumor
16324978|NCT00461578|Drug|Chlorproguanil-dapsone + artesunate|
16324979|NCT00461565|Drug|Sildenafil|A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
16324980|NCT00461565|Drug|Placebo|A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
16324981|NCT00461565|Drug|Vardenafil (Levitra, BAY38-9456)|B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
16324982|NCT00461565|Drug|Placebo|B2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
16324983|NCT00461552|Drug|Leptin|weight based, sub-cutaneous injection, twice daily
16324984|NCT00461552|Other|Placebo|weight based, sub-cutaneous injection, twice daily
16324985|NCT00461539|Other|Treatment as usual|Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
16324986|NCT00461539|Behavioral|Behavioral health intervention|Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention.
16324987|NCT00461526|Drug|crofelemer|125 mg crofelemer vs. placebo
16324988|NCT00461513|Behavioral|Intervention|Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF. Disease management in this study will use a multidisciplinary collaborative care, leveraging health information technology, and focusing on patient self-care.Collaborative care is the use of multidisciplinary teams to deliver evidence-based treatment to a defined population of patients with chronic illness.
16324989|NCT00461500|Drug|Salmeterol xinafoate/fluticasone propionate combination|SFC 100
16324990|NCT00461500|Drug|Fluticasone propionate|FP 100
16324991|NCT00461487|Behavioral|Active control on hygiene and nutrition|The active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
16324992|NCT00461487|Behavioral|Families Talking Together|The intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
16324993|NCT00461474|Behavioral|Shoulder strengthening exercises|
16324994|NCT00461474|Behavioral|Movement Optimization|
16324995|NCT00461461|Procedure|meeting nurses / physicians, quality improvement sessions|"For each iatrogenic indicator, the interventions are:
~Meeting with the ICU staff to discuss the epidemiology of patients on each theme.
~Pocket card with guidelines on the theme and ICU protocol in each study ICU.
~Feedback meeting twice a month on errors in the unit, preventability, and appropriate changes in procedures on the subject."
16324996|NCT00461448|Dietary Supplement|Potassium supplement|Patients were randomly allocated to receive either an EGJ containing 234.5 mmol microcrystalline KCl a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) or PGJ for 28 days.
16324997|NCT00461435|Procedure|hyperbaric oxygen therapy|
16324998|NCT00461422|Drug|Ganirelix|sc injection of Ganirelix 0.25 mg per day
16324999|NCT00461396|Drug|Interferon-1beta (Betaseron, BAY86-5046)|Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months
16325000|NCT00461370|Drug|SRX251|
16325001|NCT00461344|Drug|Docetaxel|
16325002|NCT00461344|Drug|Doxorubicin|
16325003|NCT00461331|Drug|Insulin Aspart|Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.
16325004|NCT00461331|Drug|Insulin Lispro|Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
16325005|NCT00461318|Procedure|Individual placement and support (vocational rehabilitation)|
16325006|NCT00461305|Drug|DRSP 3 mg/EE 20 µg (13 cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
16325007|NCT00461305|Drug|DRSP 3 mg/EE 30 µg (6 cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
16325008|NCT00461292|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor
16325009|NCT00461292|Biological|botulinum toxin Type A (300U)|botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
16325010|NCT00461292|Other|Normal saline (Placebo); botulinum toxin Type A (200U)|Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor
16325011|NCT00461292|Other|Normal saline (Placebo); botulinum toxin Type A (300U)|Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
16325012|NCT00461279|Behavioral|Cognitive Behavior Therapy|Reframing and understanding cognitions of depression
16325063|NCT00460759|Drug|Rifapentine|
16325013|NCT00461279|Behavioral|Interpersonal Psychotherapy|Established psychotherapy for depression
16325014|NCT00461266|Drug|enfuvirtide [Fuzeon]|90mg sc bid
16325015|NCT00461266|Drug|Antiretroviral therapy|As prescribed
16325016|NCT00461253|Device|Levonorgestrel-releasing IUD|"This is a case-control-study; strictly speaking the category intervention type does not apply to this study."
16325017|NCT00461253|Device|Copper IUD|"This is a case-control-study; strictly speaking the category intervention type does not apply to this study."
16325018|NCT00461214|Other|Participation in laparoscopic training curriculum|General Surgery Training Outcome
16325019|NCT00461201|Procedure|Nurse practitioner care of patients|
16325020|NCT00461162|Behavioral|Internet DSMP|Internet Dyspnea Self-management Program (i-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. I-DSMP participants will receive their accessing the modules through the website and participating in weekly online group chat sessions with the research nurse and other participants.
16325021|NCT00461162|Behavioral|Face-to-Face Dyspnea Self-management|Face-to-Face Dyspnea Self-management Program (f-DSMP): Education and skills training for dyspnea management; an individualized tailored exercise plan; self-monitoring of exacerbation symptoms and exercise; and reinforcement/personalized feedback for self management. F-DMSP participants will attend face-to-face group education sessions. The f-DSMP participants will be provide with a hard copy of the education modules and will participate in six 1-hour group sessions for a period of 6 weeks.
16325022|NCT00461162|Behavioral|Attention Control|6 Monthly general health education classes and biweekly telephone calls from a health educator.
16325023|NCT00461149|Drug|Octreotide-LAR|
16325024|NCT00461136|Drug|Aliskiren|
16325025|NCT00461123|Drug|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
16325026|NCT00461123|Drug|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
16325027|NCT00461110|Drug|BMS-663513|mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
16325028|NCT00461097|Drug|Egg oral immunotherapy|Egg white solid powder
16325029|NCT00461097|Drug|Control Group|Placebo for egg white solid
16325030|NCT00461084|Drug|BIAXIN (CLARITHROMYCIN)|Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
16325031|NCT00461084|Drug|Biaxin (clarithromycin)|Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
16325032|NCT00461071|Behavioral|Guided Self-help for Bulimia nervosa|bibliotherapy
16325033|NCT00461058|Drug|Actos|Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
16325034|NCT00461058|Drug|aleglitazar|Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
16325035|NCT00461045|Drug|MRZ 0.5 mg/m^2|NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle
16325036|NCT00461032|Drug|montelukast|montelukast 5 mg tablet Once a day (QD) for 8 weeks
16325037|NCT00461032|Drug|Comparator: Placebo|Placebo to montelukast QD for 8 weeks
16325038|NCT00461019|Procedure|Implantation and activation of the vagus nerve stimulator|Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead
16325039|NCT00461006|Drug|Actos|45mg po daily
16325040|NCT00461006|Drug|aleglitazar|0.6mg po daily
16325041|NCT00460993|Drug|Lunesta|"Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.
~Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4."
16325042|NCT00460980|Behavioral|Virtual reality laparoscopic simulator training|The aim of this project is to determine whether a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience. We aim to show that with the virtual reality trainer, operative skills will be improved and that overall operative time will be decreased.
16325043|NCT00460967|Device|Rheopheresis|8 rheopheresis treatments over 10 wks.
16325044|NCT00460967|Device|Rheopheresis|Sham treatment
16325045|NCT00460954|Drug|Sinemet® controlled release (Carbidopa/levodopa)|
16325046|NCT00460941|Drug|Placebo|sc weekly
16325047|NCT00460941|Drug|Taspoglutide 20mg|sc weekly
16325048|NCT00460941|Drug|Taspoglutide 20mg-30mg|sc weekly
16325049|NCT00460941|Drug|Taspoglutide 20mg-40mg|sc weekly
16325050|NCT00460928|Drug|intravenous immune globulin (IVIG)|
16325051|NCT00460915|Drug|Lacidipine & Amlodipine|
16325052|NCT00460902|Device|Transcranial Magnetic Stimulation (TMS)|
16325053|NCT00460889|Procedure|donor nephrectomy|The objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN.
16325054|NCT00460876|Drug|Topotecan|
16325055|NCT00460863|Procedure|using cool versus warm dialysate during hemodialysis|
16325056|NCT00460850|Drug|peginterferon alfa-2a (40KD) [PEGASYS]|180 micrograms sc weekly for 48 weeks
16325057|NCT00460837|Drug|bowel preparation: senna & gastrofin versus picolax (standard)|The intervention is a bowel cleansing procedure
16325058|NCT00460811|Drug|Linaclotide Acetate|Oral, once daily
16325059|NCT00460811|Drug|Matching placebo|Oral, once daily
16325060|NCT00460798|Other|Sutent: observational study|SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
16325064|NCT00460746|Drug|TMC125, Darunavir; Ritonavir|TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;
16325065|NCT00460733|Drug|Risedronate sodium|Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
16325066|NCT00460733|Drug|Calcium & Vitamine D3|1000 mg of calcium and 400 UI of Vitamine D3
16325067|NCT00460720|Other|Observational treatment compliance survey|Observational treatment compliance survey
16325068|NCT00460707|Drug|Casopitant 150 mg|Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
16325069|NCT00460707|Drug|Ketoconazole|Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).
16325070|NCT00460707|Drug|Casopitant 150 mg matching placebo|Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
16325071|NCT00460707|Drug|Casopitant 50 mg|Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.
16325072|NCT00460707|Drug|Casopitant 50 mg matching placebo|Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
16325073|NCT00460694|Biological|infusion of allogeneic CIK cells|infusion of allogeneic CIK cells at graded doses
16325074|NCT00460681|Drug|Thymopentin|subcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months.
16325075|NCT00460668|Behavioral|pulmonary rehabilitation|2 or 3 times a week during 8 weeks
16325076|NCT00460655|Drug|GSK1358820|botulinum toxin type A
16325077|NCT00460655|Drug|Placebo|Placebo
16325078|NCT00460642|Drug|GnRH Antagonist (Cetrotide)|
16325079|NCT00460629|Procedure|Application of activated donor T cells|Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens
16325080|NCT00460616|Drug|Cabergoline|According with our previous studies, in the patients with microprolactinoma and in those with non-tumoral hyperprolactinemia, cabergoline treatment was administered orally at a starting dose of 0.25 mg twice weekly for the first two weeks and then 0.5 mg twice weekly. After 2 months of treatment, dose adjustment was carried out every 2 months on the basis of serum PRL suppression.
16325081|NCT00460603|Drug|bevacizumab|bevacizumab 5 mg/kg every 2 weeks
16325082|NCT00460603|Drug|AG-013726|AG-013726 5 mg bid every 2 weeks
16325083|NCT00460603|Drug|AG-013736 (axitinib)|AG-013736 5 mg bid starting dose
16325084|NCT00460590|Biological|MVA 85A|ID vaccine
16325085|NCT00460577|Drug|Formoterol fumerate|12 micrograms stat (twice if necessary). Inhaled via aerolizer
16325086|NCT00460577|Drug|fenoterol/ipratropium bromide|0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.
16325087|NCT00460564|Drug|GSK1358820|botulinum toxin type A
16325088|NCT00460564|Drug|Placebo|Placebo
16325089|NCT00460551|Biological|Zalutumumab|8 mg/kg
16325090|NCT00460551|Drug|Induction chemotherapy|Combination of cisplatin and docetaxel administered as two cycles given every three weeks
16325091|NCT00460551|Radiation|Radiotherapy|64 Gy in 32 fractions over 6.5 weeks
16325092|NCT00460538|Dietary Supplement|Lectranal|"Dosage form: capsule
~1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks"
16325093|NCT00460538|Dietary Supplement|placebo|Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks
16325094|NCT00460525|Biological|FMP2.1/AS02A|3 doses administered a month apart: 50 µg recombinant subunit protein FMP2.1 (Plasmodium falciparum Apical Membrane Antigen-1 from strain 3D7 expressed in and purified from Escherichia coli), adjuvanted with 0.5 mL of AS02A (proprietary oil-in-water emulsion and phosphate buffered saline with the immunostimulants monophosphoral lipid A and QS21).
16325095|NCT00460525|Biological|Rabies Vaccine|White, freeze-dried vaccine for reconstitution with the diluent prior to use; dosage 1.0 mL of rabies vaccine.
16325096|NCT00460512|Drug|Paliperidone ER|Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons.
16325097|NCT00460499|Drug|A IV Insulin drip|These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.
16325098|NCT00460499|Drug|B Low Dose GIK|These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl
16325099|NCT00460499|Drug|C High Dose GIK|This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl
16325100|NCT00460486|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
16325101|NCT00460473|Drug|Dexmedetomidine|
16325102|NCT00460473|Drug|Placebo|
16325103|NCT00460460|Drug|AZD4877|
16325104|NCT00460447|Drug|Gemtuzumab Ozogamicin|
16325105|NCT00460434|Device|TVT|Prophylactic TVT
16325106|NCT00460434|Other|Sham|Sham TVT
16325107|NCT00460421|Drug|Palifermin|Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).
16325108|NCT00460421|Radiation|Total Body irradiation|
16325109|NCT00460421|Drug|Chemotherapy|High dose etoposide, Cyclophosphamide
16325110|NCT00460408|Drug|Macugen|Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
16325111|NCT00460395|Procedure|Surgery|
16325112|NCT00460395|Procedure|Stereotactic radiosurgery|
16325113|NCT00460382|Drug|raltegravir potassium|400 mg twice a day
16325114|NCT00460382|Drug|darunavir/ritonavir|2 pills of 300 mg twice a day
16325115|NCT00460382|Drug|etravirine|2 pills of 100 mg twice a day
16325116|NCT00460382|Drug|Optimized background regimen|NRTIs and or enfuvirtide (investigator choice)
16325117|NCT00460369|Drug|sulfadoxine-pyrimethamine|"tablets 1,25/25 mg
~1 tablet per 20 kg of body weight Single drug intake"
16325237|NCT00459420|Drug|placebo|placebo
16325118|NCT00460369|Drug|artemether-lumefantrine|"tablets 20/120 mg
~1 tablet twice daily for 3 days below 15 kg of bodyweight
~2 tablets twice daily for 3 days below 24 kg of bodyweight
~3 tablets twice daily for 3 days below 35 kg of bodyweight"
16325119|NCT00460369|Drug|amodiaquine-artesunate coformulation|"one 25mg/67,5mg tablet, once daily for 3 days below 9 kg
~one 50/135mg tablet, once daily for 3 days below 18 kg"
16325120|NCT00460356|Other|Laboratory Biomarker Analysis|Correlative studies
16325121|NCT00460356|Procedure|Lymphadenectomy|Undergo lymphadenectomy
16325122|NCT00460343|Other|extensive implementation programme|experimental pharmacists follow an extensive implementation programme. They attend two interactive half a day educational meetings tailored to individual needs: one at start of the intervention, and one in May or September 2007. Special attention is given to multiprofessional cooperation with general practitioners and nurse practitioners. Additionally, guided by their own project planning pharmacists receive three or more telephone calls, both as a reminder, feedback, and in order to investigate whether they need any more help.
16325123|NCT00460343|Other|control|pharmacists only receive a written manual with instructions to implement the patient compliance intervention.
16325124|NCT00460317|Drug|AMG 706|125 mg QD orally every day
16325125|NCT00460317|Drug|placebo|125 mg QD orally every day
16325126|NCT00460317|Drug|paclitaxel|200mg/m2 on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
16325127|NCT00460317|Drug|carboplatin|AUC of 600mg/mL x min by Calvert formula on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles
16325128|NCT00460304|Drug|pramlintide|
16325129|NCT00460304|Procedure|continuous glucose monitoring|
16325130|NCT00460291|Device|Implantation of the ProVena vein graft during bypass surgery|
16325131|NCT00460278|Drug|XL418|
16325132|NCT00460265|Drug|ARM 2|Subjects will receive Cisplatin plus 5FU
16325133|NCT00460265|Drug|ARM 1|Subjects will receive Panitumumab plus cisplatin and 5FU
16325134|NCT00460252|Procedure|insulin titration applying a computer algorithm|
16325135|NCT00460239|Drug|Buprenorphine|Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week.
16325136|NCT00460239|Drug|Morphine|Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind
16325137|NCT00460239|Drug|Placebo|Intramuscular; double blind; once per week
16325138|NCT00460226|Drug|lamotrigine|lamotrigine treatment for 12weeks
16325139|NCT00460213|Drug|Valsartan 80mg daily|
16325140|NCT00460213|Drug|Valsartan 160mg daily|
16325141|NCT00460200|Genetic|polymorphism analysis|
16325142|NCT00460200|Other|laboratory biomarker analysis|
16325143|NCT00460200|Other|physiologic testing|
16325144|NCT00460200|Other|questionnaire administration|
16325145|NCT00460200|Procedure|conventional surgery|
16325146|NCT00460200|Procedure|fatigue assessment and management|
16325147|NCT00460200|Procedure|psychosocial assessment and care|
16325148|NCT00460187|Device|Percutaneous intervention of the carotid artery|
16325149|NCT00460174|Biological|bevacizumab|10 mg/kg every 2 weeks as an intravenous infusion after gemcitabine and before radiation
16325150|NCT00460174|Drug|gemcitabine|1000 mg/m2, 30 minute intravenous infusion, cycle 1 (weeks 1, 2), cycle 2 (weeks 4, 5, 6) and cycle 3 (weeks 8 and 9). During cycle 2, gemcitabine will be delivered prior to radiation therapy
16325151|NCT00460174|Procedure|conventional surgery|If resectable, patients will undergo surgery no less than 6 weeks following last dose of bevacizumab. Unresectable patients will not undergo surgery.
16325152|NCT00460174|Radiation|radiation therapy|2.4 Gy fractions, 5 fractions/week during cycle 2 only (weeks 4, 5, 6). Total dose 36 Gy.
16325153|NCT00460161|Procedure|acupuncture|2 treatments/week for 4 weeks
16325154|NCT00460161|Other|placebo/sham acupuncture|2 treatments/week for 4 weeks
16325155|NCT00460148|Drug|Ropinirole|
16325156|NCT00460135|Behavioral|resistance training|2 times a week resistance training
16325157|NCT00460109|Biological|denileukin diftitox|
16325158|NCT00460109|Biological|rituximab|
16325159|NCT00460096|Drug|Kamada-API|
16325160|NCT00460083|Drug|Elidel(R) (pimecrolimus 1%)|
16325161|NCT00460083|Device|EpiCeram(R) -ceramide based barrier repair cream|
16325162|NCT00460057|Drug|Alendronate|Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
16325163|NCT00460031|Drug|ketoconazole|400 tid
16325164|NCT00460031|Drug|lenalidomide|Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
16325165|NCT00460031|Drug|therapeutic hydrocortisone|20mg qam 10mg qhs
16325166|NCT00460018|Behavioral|Diet, Exercise, and Breastfeeding Intervention|"Phase I (Pregnancy Program from GDM diagnosis to delivery): One in-person session with the lifestyle coach, two phone calls with the lifestyle coach, and one in-person session with the lactation consultant
~Phase II (Early Post-partum Period from delivery to 6 weeks post-partum): Two to four routine phone calls with the lactation consultant
~Phase III (Late Post-partum Period 6 weeks to 7 months postpartum): Two in-person sessions with the lifestyle coach, up to 11 phone calls with the lifestyle coach, and two to three routine calls with the lactation consultant
~Phase IV (Maintenance Phase 8 months to 1 year postpartum): One newsletter from the lifestyle coaches, two recipe letters and continue calls with the lifestyle coach (optional)"
16325167|NCT00459992|Drug|Betahistine Hydrochloride|
16325168|NCT00459979|Drug|sunitinib malate|Sunitinib will be dosed at 50 mg p.o. daily
16325169|NCT00459979|Procedure|conventional surgery|nephrectomy
16325170|NCT00459966|Procedure|Preoperative rehabilitation|
16325171|NCT00459953|Drug|Extended treatment|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
16325172|NCT00459940|Drug|Pioglitazone|
16325173|NCT00459927|Device|Floseal tonsillectomy|
16325174|NCT00459927|Device|Coblation tonsillectomy|
16325175|NCT00459914|Device|cpap treatment during sleep|CPAP
16325176|NCT00459901|Drug|Erlotinib and capecitabine|
16325282|NCT00459043|Drug|ZD6474|Taken orally once every morning
16325177|NCT00459888|Device|PolarCath Peripheral Dilatation System (Boston Scientific)|
16325178|NCT00459875|Drug|sunitinib malate|
16325179|NCT00459862|Other|laboratory biomarker analysis|Correlative study
16325180|NCT00459862|Drug|pazopanib hydrochloride|Given orally
16325181|NCT00459849|Procedure|Intraoperative ultrasonography|Intraoperative ultrasonography will be used to determine plaque placement.
16325182|NCT00459836|Drug|PR-104|
16325183|NCT00459836|Drug|docetaxel|
16325184|NCT00459836|Drug|gemcitabine hydrochloride|
16325185|NCT00459836|Other|laboratory biomarker analysis|
16325186|NCT00459836|Other|pharmacological study|
16325187|NCT00459823|Drug|E7107|E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.
16325188|NCT00459810|Drug|transdermal estradiol|Transdermal estradiol given 0.2mg/day for duration of study.
16325189|NCT00459810|Drug|paclitaxel poliglumex|Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2
16325190|NCT00459797|Device|Conventional (reusable) Glidescope|
16325191|NCT00459797|Device|Single-use Glidescope videolaryngoscope|
16325192|NCT00459784|Procedure|Dementia Training Program|
16325193|NCT00459771|Drug|AT1 blocker candesartan|AT1 blocker candesartan, 32 mg oral QD
16325194|NCT00459771|Drug|Placebo|Placebo, 32 mg, oral QD
16325195|NCT00459758|Device|Hans unit|
16325196|NCT00459745|Drug|Pravafen|
16325197|NCT00459745|Drug|Pravastatin|
16325198|NCT00459745|Drug|Fenofibrate|
16325199|NCT00459732|Dietary Supplement|Zinc|25 mg of elemental zinc as zinc sulphate take once daily for 18 months
16325200|NCT00459732|Dietary Supplement|Placebo|Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months
16325201|NCT00459719|Drug|Tacrolimus modified-release|oral
16325202|NCT00459719|Drug|Prograf|oral
16325203|NCT00459706|Device|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
16325204|NCT00459706|Device|Enbrel 50 mg Autoinjector|Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
16325205|NCT00459693|Drug|[11C]PBR28|
16325206|NCT00459680|Device|Laser acupoint treatment|Laser
16325207|NCT00459680|Procedure|Acupuncture|Needle acupuncture on ST36 and LI11.
16325208|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
16325209|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
16325210|NCT00459667|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|"Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.
~Phase B: All patients will receive 500µg s.c.every other day (open-label)."
16325211|NCT00459654|Drug|Radium-223 dichloride (BAY88-8223)|Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.
16325212|NCT00459654|Drug|Saline|Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.
16325213|NCT00459641|Drug|I-040302|doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
16325214|NCT00459641|Other|Standard of Care|Bone marrow aspirate or steroids
16325215|NCT00459628|Radiation|Conventional radiotherapy|Radiation treatment delivered by conventional linear accelerator using matching fields
16325216|NCT00459628|Radiation|Tomotherapy|CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
16325217|NCT00459615|Drug|Artesunate for Injection|
16325218|NCT00459589|Behavioral|nutritional intervention with dietician plus usual nutritional care|nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d
16325219|NCT00459589|Behavioral|usual nutritional care|usual nutritional care
16325220|NCT00459563|Drug|Vitamin D|200,000 IU once weekly for 3 weeks (600,000 IU total dose)
16325221|NCT00459563|Drug|calcitriol|calcitriol 0.5 mcg twice a day for 1 week
16325222|NCT00459563|Drug|Placebo|Placebo once a week for 3 weeks
16325223|NCT00459550|Drug|GSK933776|"Part A planned doses cohort 1 to cohort 3 0.001 mg/kg, 0.01 mg/kg and 0.1 mg/kg.
~Part B planned doses cohort 4 to cohort 7 0.1 mg/kg, 1mg/kg, 3mg/kg and 10 mg/kg"
16325224|NCT00459550|Drug|Placebo to match GSK933776|Part A first 2 cohorts 5 patients per cohort 2 placebo and 3 active third cohort part A 2 placebo 6 active. Part B 8 patients per cohort 2 placebo 6 active.
16325225|NCT00459537|Drug|terbinafine hydrogen chloride|10 % terbinafine hydrogen chloride (HCL)
16325226|NCT00459537|Drug|amorolfine nail lacquer|5 % amorolfine nail lacquer
16325227|NCT00459524|Behavioral|Questionnaire|Questionnaires taking about 30 minutes to complete.
16325228|NCT00459524|Behavioral|Neurocognitive Testing|Neurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
16325229|NCT00459511|Procedure|Blood AM, IL-6, ACTH, Cortisol, Glucose and Insulin|
16325230|NCT00459485|Dietary Supplement|zinc sulfate|20 or 10 mg zinc per day for 3 weeks
16325231|NCT00459485|Dietary Supplement|Placebo|Daily placebo for 3 weeks
16325232|NCT00459472|Behavioral|laparoscopic training curriculum|All general surgery interns and PGY-2-5's already participate in a surgery training curriculum that includes lectures, surgery, laparoscopic training, attending surgeons evaluating performance of residents at the end of surgical procedures, written tests, and skills tests.
16325233|NCT00459459|Procedure|Fine needle aspiration of the thyroid|
16325234|NCT00459446|Drug|MS-325 Injection (Gadofosveset Trisodium)|
16325235|NCT00459433|Procedure|Biopsychosocial intervention|Psychosocial versus usual care
16325236|NCT00459420|Drug|Caffeine 100-200 mg BID|Caffeine 100 mg BID for three weeks, then 200 mg BID for three weeks, then 100 mg BID for 1 week, then placebo
16325238|NCT00459407|Dietary Supplement|defined green tea catechin extract|Given orally
16325239|NCT00459407|Drug|placebo|Given orally
16325240|NCT00459407|Other|immunohistochemistry staining method|Correlative studies
16325241|NCT00459407|Other|immunoenzyme technique|Correlative studies
16325242|NCT00459407|Other|laboratory biomarker analysis|Correlative studies
16325243|NCT00459407|Procedure|biopsy|Undergo biopsy
16325244|NCT00459407|Other|mass spectrometry|Correlative studies
16325245|NCT00459407|Other|high performance liquid chromatography|Correlative studies
16325246|NCT00459381|Drug|pazopanib hydrochloride|Given orally
16325247|NCT00459381|Other|laboratory biomarker analysis|Correlative studies
16325248|NCT00459368|Behavioral|Feedback of patient adherence information|Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.
16325249|NCT00459368|Behavioral|Active control group|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
16325250|NCT00459355|Behavioral|Home Safety Toolkit|Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.
16325251|NCT00459342|Drug|dasatinib|Given orally
16325252|NCT00459329|Behavioral|Program to Encourage Active, Rewarding Lives (PEARL)|"Eight 50-minute in-home sessions over 19 weeks with a masters-level social work counselor using Problem Solving Therapy (PST).
~PST is a skills-enhancing behavioral depression treatment based on the assumption that an accumulation of problems in living cause and maintain depressive symptoms, and through systematically identifying and addressing these problems, patients achieve decreased depressive symptoms. Counselors also help participants to increase social and physical activities and to incorporate pleasant activities into patients' lives.
~Counselors provide education and monitoring for antidepressant use, and work with the participant's physician and PEARL psychiatrist to recommend initiating or adjusting antidepressant medications. The PHQ-9 is administered at each session to track depression change.
~After 19 weeks, counselors will maintain monthly telephone calls with participants, administering the PHQ-9 and assessing PST success."
16325253|NCT00459316|Biological|Quadrivalent meningococcal conjugate vaccine|MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than three times for each participant, depending on adverse reactions.
16325254|NCT00459303|Device|aspherical intraocular lens|implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
16325255|NCT00459303|Device|spherical intraocular lens|implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
16325256|NCT00459290|Drug|mifepristone|
16325257|NCT00459277|Drug|Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|
16325258|NCT00459264|Drug|Folic Acid|Folic acid oral solution 2.5mg/5ml daily for up to 3 years
16325259|NCT00459264|Drug|Placebo|Matching placebo for folic acid oral solution (2.5mg/5ml)
16325260|NCT00459238|Other|counseling intervention|subjects will receive telephone based counseling
16325261|NCT00459238|Other|educational intervention|subjects will received telephone based education
16325262|NCT00459225|Drug|Iron (ferrous sulfate)|The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants.
16325263|NCT00459212|Drug|GTI-2040|Given IV
16325264|NCT00459212|Procedure|pharmacological study|Correlative study
16325265|NCT00459212|Procedure|laboratory biomarker analysis|Correlative study
16325266|NCT00459186|Drug|RAD001|Daily for two weeks
16325267|NCT00459186|Drug|Docetaxel|Infusion once per cycle
16325268|NCT00459186|Drug|Prednisone|Prednisone 5 mg by mouth twice daily
16325269|NCT00459173|Drug|rimonabant (SR141716)|
16325270|NCT00459160|Procedure|Intraoperative Hypotensive Resuscitation|Patients will have a target minimum MAP of 50 for the case
16325271|NCT00459134|Dietary Supplement|ArginMax|Given orally
16325272|NCT00459134|Dietary Supplement|Placebo|Given orally
16325273|NCT00459121|Drug|carboplatin|Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1
16325274|NCT00459121|Drug|paclitaxel|Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.
16325275|NCT00459121|Drug|Zactima|Zactima- 100 mg orally daily, starting on day 1 of cycle 1.
16325276|NCT00459121|Procedure|neoadjuvant therapy|Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
16325277|NCT00459108|Drug|dasatinib|Given orally
16325278|NCT00459082|Drug|Dexmedetomine|
16325279|NCT00459069|Biological|Dendritic Cell Tumor Fusion Vaccine|Vaccine administered on weeks 0, 3 and 6
16325280|NCT00459056|Drug|Carvedilol CR + Lisinopril|Participants were given Carvedilol CR + Lisinopril for three months. Oral medication. Carvedilol CR and Lisinopril combination therapy was initiated at 20 mg and 10 mg, respectively. Patients returned one week later and doses of carvedilol CR and lisinopril were increased to 40 mg and 20 mg, respectively, depending on blood pressure.
16325281|NCT00459056|Drug|Lisinopril + HCTZ|Participants were given Lisinopril + HCTZ for three months. Oral medication. Lisinopril + HCTZ combination therapy was initiated at 12.5 mg and 10 mg, respectively. Patients returned 1 week later and doses of hydrochlorothiazide and lisinopril were increased to 25 mg and 20 mg, respectively, depending on blood pressure levels.
16325283|NCT00459043|Drug|Docetaxel|Given on the first day of every treatment cycle (every 3 weeks)
16325284|NCT00459030|Other|educational intervention via internet|additional cancer screening information via password protected internet site
16325285|NCT00459030|Other|educational intervention mailed|
16325286|NCT00459030|Other|No additional educational intervention|
16325287|NCT00459017|Device|Portable blood pressure wrist manometer|
16325288|NCT00459004|Drug|rimonabant (SR141716)|
16325289|NCT00458991|Drug|Dextromethorphan and Caffeine|"All subjects received standard medical therapy with rhGH and at specified times low doses of the pharmacologic probes (e.g., caffeine and dextromethorphan) as surrogate markers to determine CYP450 activity. The only direct treatment effect measured was the biological response to rhGH."
16325290|NCT00458978|Drug|Cediranib Maleate|Given orally
16325291|NCT00458978|Other|Laboratory Biomarker Analysis|Correlative studies
16325292|NCT00458952|Drug|Ultratrace Iobenguane (MIBG) I 131|Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose
16325293|NCT00458913|Drug|bortezomib|
16325294|NCT00458913|Drug|cisplatin|
16325295|NCT00458900|Drug|IV and enteral administration of moxifloxacin|IV and enteral administration of moxifloxacin
16325296|NCT00458887|Procedure|management of therapy complications|Undergo hearing tests
16325297|NCT00458874|Behavioral|CIMT results|"Both groups will receive a weekly confidential packet of scripted materials (e.g. educational materials, class schedules, feedback from diet/exercise logs). The R-CIMT group will also receive an CIMT report which contains a copy of one of their own ultrasound scans, with a comparison normal scan. This report will also include the CIMT thickness, an interpretation that states their measurements are in the highest quartile for persons of their age and gender, and associated CVD risk. Interpreting Your CIMT Results tutorial will be included in the first weekly packet to educate subjects on the detection of atherosclerosis with carotid ultrasound. The CIMT results are withheld from the W-CIMT group until the end of their study participation along with the CIMT tutorial."
16325298|NCT00458861|Biological|BG9924|Subcutaneous administration of BG9924 given every other week for 12 weeks
16325299|NCT00458861|Other|Placebo Comparator|Subcutaneous administration of placebo given every other week for 12 weeks
16325300|NCT00458848|Drug|asparaginase|
16325301|NCT00458848|Drug|daunorubicin hydrochloride|
16325302|NCT00458848|Drug|etoposide|
16325303|NCT00458848|Drug|idarubicin|
16325304|NCT00458848|Drug|imatinib mesylate|
16325305|NCT00458848|Drug|mercaptopurine|
16325306|NCT00458848|Drug|methotrexate|
16325307|NCT00458848|Drug|methylprednisolone|
16325308|NCT00458848|Drug|mitoxantrone hydrochloride|
16325309|NCT00458848|Drug|prednisone|
16325310|NCT00458848|Drug|vincristine sulfate|
16325311|NCT00458848|Procedure|allogeneic hematopoietic stem cell transplantation|
16325312|NCT00458848|Procedure|autologous hematopoietic stem cell transplantation|
16325313|NCT00458848|Procedure|peripheral blood stem cell transplantation|
16325314|NCT00458848|Radiation|radiation therapy|
16325315|NCT00458835|Drug|Ciclesonide|
16325316|NCT00458822|Drug|bortezomib|Given IV
16325317|NCT00458822|Drug|dexamethasone|Given orally
16325318|NCT00458809|Drug|oxaliplatin|Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin
16325319|NCT00458796|Drug|zoledronic acid|
16325320|NCT00458796|Procedure|quality-of-life assessment|
16325321|NCT00458783|Biological|Prolonged RBC storage|Transfusion with oldest available matching RBCs
16325322|NCT00458783|Biological|Short RBC storage|Transfusion with youngest available matching RBCs
16325323|NCT00458770|Procedure|position emission transaxial tomography|cerebral position emission transaxial tomography using 18Fluorodeoxyglucose
16325324|NCT00458744|Drug|talotrexin|
16325325|NCT00458744|Procedure|chemotherapy|
16325326|NCT00458731|Biological|bevacizumab|Given IV
16325327|NCT00458731|Drug|cediranib maleate|Given orally
16325328|NCT00458718|Drug|rimonabant (SR141716)|
16325329|NCT00458705|Drug|bortezomib|
16325330|NCT00458705|Drug|dexamethasone|
16325331|NCT00458705|Drug|pegylated liposomal doxorubicin hydrochloride|
16325332|NCT00458705|Drug|thalidomide|
16325333|NCT00458679|Biological|CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE|Patients will receive a fixed dose (2 x 10^7) of IL-2 secreting B-cells together with (2 x 10^7)hCD40L expressing B-cells. They will receive 18 deltoid injections over 52 weeks.
16325334|NCT00458653|Biological|Dendritic Cell Tumor Fusion|"Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.
~Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT"
16325335|NCT00458614|Drug|Lansoprazole|
16325336|NCT00458601|Drug|CDX-110 with GM-CSF|Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
16325337|NCT00458601|Drug|Temozolomide|Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
16325338|NCT00458588|Other|physiologic testing|
16325339|NCT00458588|Other|questionnaire administration|
16325340|NCT00458588|Procedure|breast imaging study|
16325341|NCT00458588|Procedure|dual x-ray absorptometry|
16325342|NCT00458588|Procedure|evaluation of cancer risk factors|
16325343|NCT00458588|Procedure|magnetic resonance imaging|
16325344|NCT00458575|Drug|CNTO 2476|Participant 1 will receive 5.6x100000; Participants 2, 3, 5, 6, and 7 will receive 6.0x10000; Participant 4 will receive 3.0x100000; and Participants 8 and 9 will receive 1.2x100000 of CNTO 2476 as a single dose of viable cells in phosphate buffered saline (PBS) in a total volume of 100 μL injected subretinally.
16325345|NCT00458549|Dietary Supplement|omega-3 fatty acids|omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
16325346|NCT00458549|Procedure|biopsy|
16325347|NCT00458536|Biological|Dendritic Cell Tumor Fusion Vaccine|3 vaccinations at three week intervals
16325348|NCT00458536|Drug|Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)|Combined with the vaccine in the remaining subjects after the first 6 are enrolled.
16325349|NCT00458523|Biological|alemtuzumab|
16325350|NCT00458523|Genetic|fluorescence in situ hybridization|
16325351|NCT00458523|Genetic|mutation analysis|
16325352|NCT00458523|Other|flow cytometry|
16325353|NCT00458510|Drug|Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|treatment of up to 4 episodes of pain per day
16325354|NCT00458497|Device|Holofiber fabric|Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET) fabric to which Holofiber particles have been added during fiber manufacture.
16325355|NCT00458497|Device|PET fabric|Subjects will be given 3 pairs of socks (subjects with foot pain only) and bedding (mattress pad)fabricated from 1.8 dernier polyethylene terephthalate (PET)fabric.
16325356|NCT00458484|Radiation|stereotactic radiosurgery|"Series I: Radiation will be delivered in 4 fractions.
~Series II: Radiation will be delivered in 3 fractions."
16325357|NCT00458484|Procedure|Renal Biopsy|At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
16325358|NCT00458484|Procedure|Serum Blood Markers|ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
16325359|NCT00458471|Device|Insertion of a urinary catheter coated with benign E. coli|
16325360|NCT00458458|Drug|Norethindrone Acetate (NA)|52 weeks of treatment with Norethindrone Acetate
16325361|NCT00458458|Drug|GnRH Agonist (Lupron Depot)|24 weeks of treatment with Lupron Depot then 28 weeks of treatment with Norethindrone Acetate
16325362|NCT00458445|Drug|SPD465|
16325363|NCT00458445|Other|Placebo|Placebo is a material that may look similar to SPD465, however, contains no active drug.
16325364|NCT00458419|Drug|naloxone versus placebo|10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
16325365|NCT00458419|Drug|intravenous injection of normal saline or naloxone|Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
16325366|NCT00458406|Device|Bi-Flex|"Bi-Flex: Subjects in this arm undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
~Positive pressure used during sleep for 3 months"
16325367|NCT00458406|Device|CPAP|"CPAP: Subjects in this arm undergo standard continuous positive airway pressure (CPAP) therapy.
~Positive pressure used during sleep for 3 months."
16325368|NCT00458393|Drug|daily TDF/FTC|daily oral medication
16325369|NCT00458393|Drug|Placebo|daily oral medication
16325370|NCT00458380|Procedure|Controlled ovarian stimulation, perifollicular vascularity assessment, IVF, embryo transfer.|
16325371|NCT00458367|Drug|Open label risperidone long acting injectable|intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg
16325372|NCT00458354|Device|Spinal Sealant|Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.
16325373|NCT00458354|Procedure|Standard Methods of Closing of the Dura|Standard methods such as the closing of the dura with stitches.
16325374|NCT00458341|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water, milk, or apple juice. Participants are to receive a total of 42 doses of ataluren during each cycle, for a total of 84 doses of ataluren in both cycles.
16325375|NCT00458328|Drug|Z-338|
16325376|NCT00458315|Drug|Cisplatin|
16325377|NCT00458315|Drug|Paclitaxel|
16325378|NCT00458315|Drug|Gemcitabine|
16325379|NCT00458315|Drug|Avastin (Bevacizumab)|
16325380|NCT00458302|Drug|darunavir (DRV, TMC114)|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
16325381|NCT00458302|Drug|darunavir (DRV, TMC114)|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
16325382|NCT00458289|Drug|Lanthanum carbonate (chewed vs. crushed)|single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
16325383|NCT00458276|Drug|tezosentan|Tezosentan (ACT-050089, Ro 61-0612) as a 1% solution in 0.9% NaCl (i.e., normal saline) for i.v. use.
16325384|NCT00458276|Drug|placebo|Placebo (i.e., normal saline) for i.v. use.
16325385|NCT00458263|Drug|Somatotropin growth hormone recombinant human|daily Sub Cutaneous injections
16325386|NCT00458250|Procedure|Haploidentical hematopoietic stem cell transplantation|
16325387|NCT00458250|Drug|Busulfan|
16325388|NCT00458250|Drug|Cyclophosphamide|
16325389|NCT00458250|Drug|CAMPATH-1H|
16325390|NCT00458250|Drug|Cyclosporin A|
16325391|NCT00458250|Drug|Methotrexate|
16325392|NCT00458237|Drug|Everolimus|Everolimus is being administered orally 7 days per week.
16325393|NCT00458237|Drug|Trastuzumab|Trastuzumab is being administered at a dose of 6 mg/kg intravenously once every 21 days.
16325394|NCT00458224|Behavioral|parental counseling|Group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training
16325395|NCT00458211|Drug|ziprasidone|Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
16325396|NCT00458198|Behavioral|Integrated behavioral therapy (BT)|Participants in the BT condition will receive twenty 60-minute sessions over 24 weeks. Sessions will focus on graduated exposure to new speaking situations as the primary agent of anxiety reduction. Behavioral procedures will include systematic desensitization, shaping, and self-modeling procedures. Although a variety of exposure exercises will be routinely conducted in-session, any behavioral assignments will take place outside of session. Behavioral exercises will be implemented, as needed, in a modular fashion. For example, exercises may focus on speaking in-session to therapist, either at school or at home with others present. The therapist will be primarily responsible for developing the exposure parameters, but collaboration of parent, teacher, child will be emphasized increasingly over time. Reinforcement for attempts to complete assignments (contingency management program) will occur throughout treatment.
16325397|NCT00458185|Drug|etanercept|
16325398|NCT00458172|Behavioral|Assessment of beliefs and attitudes|
16325399|NCT00458159|Drug|CC-11006|Doses: 10mg, 15mg, 25mg, 35mg, & 50mg, taken once daily, orally.
16325400|NCT00458146|Drug|MM-093|60mg MM-093/week as a subcutaneous injection for 3 months
16325401|NCT00458133|Behavioral|exercise|compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
16325402|NCT00458120|Biological|rDEN1delta30|Live attenuated 10^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.
16325403|NCT00458120|Biological|rDEN2/4delta30(ME)|Live attenuated 10^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.
16325404|NCT00458120|Biological|Placebo to rDEN1delta30 or rDEN2/4delta30(ME)|Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)
16325405|NCT00458107|Drug|SCA-136|
16325406|NCT00458094|Behavioral|Physical activity intervention with peer support (PA+PS)|Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions.
16325407|NCT00458094|Behavioral|Physical activity intervention without peer support (PA)|Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.
16325408|NCT00458081|Drug|Rimonabant|20 mg once per day + slightly reduced calorie diet
16325409|NCT00458081|Drug|Placebo|placebo once per day + slightly reduced calorie diet
16325410|NCT00458068|Drug|Oral administration of ferrous sulphate|
16325411|NCT00458055|Drug|Atorvastatin; Fenofibrate; Niacin|Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.
16325412|NCT00458042|Drug|treprostinil sodium|
16325413|NCT00458029|Behavioral|integrated program of nutrition, activity, behavior, and promotion|implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008
16325414|NCT00458016|Drug|MB07803|Daily oral administration
16325415|NCT00458016|Drug|Placebo|Daily oral administration
16325416|NCT00458003|Drug|Ephedrine|Ephedrine concentration: 8 mg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
16325417|NCT00458003|Drug|Phenylephrine|Phenylephrine concentration: 100 mcg/mL. The infusion will be initiated immediately after completion of the spinal injection at a rate of 1 mL/min and continued for a minimum of 2 min after which the infusion will be stopped, continued or increased based on the SBP each minute. After each SBP measurement the infusion will be stopped if SBP > 80% baseline, and the infusion will be continued or restarted if the SBP is approximately equal to 80% baseline. The infusion will be increased by 1 mL/min if the SBP < 80% baseline. Each time there is hypotension the patient will receive a 1 mL IV bolus of the study solution and the infusion will be increased by 1 mL/min until delivery.
16325418|NCT00457990|Drug|Oral administration of ferrous sulphate|
16325419|NCT00457977|Biological|Pneumovax (PPSV23)|Injection
16325420|NCT00457977|Biological|Prevnar (PCV7)|Injection
16325421|NCT00457964|Drug|RAD001|5 and 10 mg/day or 30, 50, 70mg/week
16325422|NCT00457951|Drug|Open-Label|ODSH administered open-label
16325423|NCT00457951|Drug|Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride|Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride
16325424|NCT00457951|Drug|ODSH|Randomized, Blinded, ODSH Arm
16325425|NCT00457938|Other|low-fat diet ( Still recruiting )|This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.
16325426|NCT00457938|Other|Diet|10 % versus 35 % fat in diet
16325427|NCT00457925|Drug|GSK221149A|
16325428|NCT00457899|Drug|Quetiapine IR (Immediate Release)|oral
16325429|NCT00457873|Drug|0.9% saline in 5% dextrose (intravenous)|
16325430|NCT00457873|Drug|0.45% saline in 5% dextrose (intravenous)|
16325431|NCT00457860|Drug|Immunotoxin therapy|
16325432|NCT00457860|Drug|CAT-8015 immunotoxin|
16325433|NCT00457860|Procedure|Biological therapy|
16325434|NCT00457834|Device|InSync III|Bi-ventricular pacing from leads in LV+RVA or LV+RVOT
16325435|NCT00457821|Drug|Ivacaftor 25 mg/75 mg|25 mg or 75 mg q12h for a total of 28 days (Part 1)
16325436|NCT00457821|Drug|Ivacaftor 75 mg/150 mg|75 mg or 150 mg q12h for a total of 28 days (Part 1)
16325437|NCT00457821|Drug|Ivacaftor 150 mg or 250 mg|150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2)
16325438|NCT00457821|Drug|Placebo|Given q12h for 28 days each in Part 1 and Part 2 of the study
16325439|NCT00457808|Drug|Rapamycin, sirolimus|
16325440|NCT00457795|Drug|brimonidine 0.1% (Alphagan® P)|Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
16325441|NCT00457782|Drug|KW-2478|Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts
16325442|NCT00457769|Drug|Donepezil and self-generated memory training|Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
16325443|NCT00457769|Drug|Donepezil and experimenter-administered memory training|Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
16325444|NCT00457756|Dietary Supplement|BiosLife Complete|
16325445|NCT00457756|Dietary Supplement|Placebo|
16325446|NCT00457743|Drug|Sunitinib malate (SU011248)|SU011248
16325447|NCT00457730|Drug|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
16325448|NCT00457730|Drug|Placebo|Subjects are randomized to either Duloxetine or Placebo
16325449|NCT00457717|Drug|0.25 % atropine|
16325450|NCT00457717|Drug|0.5 % atropine|
16325451|NCT00457717|Procedure|0.25 % atropine+auricular acupoints|
16325512|NCT00457184|Procedure|Blood tests|
16325452|NCT00457691|Drug|5 fluorouracil|400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
16325453|NCT00457691|Drug|irinotecan|180mg/m2 iv day 1 every 14 days
16325454|NCT00457691|Drug|levo- leucovorin|200mg/m2 iv; day 1 every 14 days
16325455|NCT00457691|Drug|sunitinib|37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
16325456|NCT00457691|Drug|5 fluorouracil|400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
16325457|NCT00457691|Drug|irinotecan|180mg/m2 iv day 1 every 14 days
16325458|NCT00457691|Drug|levo- leucovorin|200mg/m2 iv; day 1 every 14 days
16325459|NCT00457691|Drug|placebo|37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
16325460|NCT00457678|Drug|Visudyne|
16325461|NCT00457678|Drug|Lucentis|
16325462|NCT00457678|Drug|Dexamethasone|
16325463|NCT00457665|Drug|Nelfinavir|
16325464|NCT00457665|Drug|Efavirenz|
16325465|NCT00457652|Drug|Rosuvastatin|7 day treatment rosuvastatin 20mg
16325466|NCT00457639|Drug|Cholic Acid|Capsules of active Cholic Acid or matching placebo, total dose is 15 mg/kg per day, maximum dose of 1500 mg per day, taken PO, BID.
16325467|NCT00457626|Drug|Valsartan|Extemporaneous suspension of valsartan, orally.
16325468|NCT00457613|Drug|bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)|
16325469|NCT00457600|Procedure|patient-driven health IT product|
16325470|NCT00457574|Drug|GMX1777|
16325471|NCT00457548|Behavioral|Brief Telephone Counseling for risky aclohol use|Two brief sessions (30-40 minutes) of brief counseling using a motivational interviewing approach. The counseling session are delivered by telephone and focus on the alcohol use of inuured ED patients who randomize into the treatment arm of the study. Patient who randomize into the controla rm of the study receive standard emergency department care only plus study assessments.
16325472|NCT00457522|Behavioral|Nurse/community health worker telephone intervention|
16325473|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
16325474|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
16325475|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
16325476|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant|0.5 mL, Intramuscular
16325477|NCT00457509|Biological|A/H5N1 inactivated, split-virion influenza vaccine|0.5 mL, Intramuscular
16325478|NCT00457496|Behavioral|Cognitive, behavioral, exercise|Relaxation exercises once a day, visual feedback, exercises for neck and shoulder
16325479|NCT00457483|Drug|hydrochlorothiazide|12.5 mg once-a-day
16325480|NCT00457483|Drug|valsartan, 80 mg once-a-day|80 mg once-a-day
16325481|NCT00457470|Drug|AG-014699|
16325482|NCT00457457|Drug|Tamsulosin|Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
16325483|NCT00457457|Drug|UK-369,003|UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED
16325484|NCT00457444|Drug|Pollen|
16325485|NCT00457431|Procedure|Mild therapeutic hypothermia|Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
16325486|NCT00457418|Drug|PEG-Intron|
16325487|NCT00457405|Drug|dipyridamole|dipyridamole 200mg twice daily
16325488|NCT00457392|Drug|erlotinib|plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
16325489|NCT00457392|Drug|sunitinib|Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
16325490|NCT00457392|Drug|erlotinib|plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
16325491|NCT00457392|Drug|placebo|Placebo daily by oral capsules in a continuous regimen
16325492|NCT00457379|Behavioral|physical exercise|
16325493|NCT00457366|Drug|Quetiapine|Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD
16325494|NCT00457366|Drug|Haloperidol|given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
16325495|NCT00457366|Drug|Lorazepam|given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
16325496|NCT00457366|Drug|Cogentin|given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
16325497|NCT00457353|Drug|Bacillus Clausii|For 5 days
16325498|NCT00457353|Other|Oral rehydration therapy|For 5 days
16325499|NCT00457340|Drug|Atorvastatin 80mg|
16325500|NCT00457327|Procedure|protective ileostomy|
16325501|NCT00457314|Behavioral|Exercise|Regular exercise training
16325502|NCT00457301|Behavioral|HUI score card|Patients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients
16325503|NCT00457288|Drug|TF 002|
16325504|NCT00457275|Drug|MK0653, ezetimibe / Duration of Treatment: 4 Weeks|
16325505|NCT00457262|Procedure|soy consumption|
16325506|NCT00457249|Biological|ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
16325507|NCT00457249|Biological|DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed|0.5 mL, IM
16325508|NCT00457223|Procedure|Amniotic membrane transplantation using fibrin glue|After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
16325509|NCT00457210|Procedure|Brain Radiotherapy/Stereotactic Radiosurgery|
16325510|NCT00457197|Drug|Placebo|Inactive ingredient matching the active medication in appearance.
16325511|NCT00457197|Drug|Quetiapine|Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
16325514|NCT00457158|Device|ALN optional filter|J1 : ALN optional filter M3 : ALN optional filter removed
16325515|NCT00457145|Drug|Ranibizumab|
16325516|NCT00457132|Device|APOS biomechanical gait system|
16325517|NCT00457119|Drug|RAD001|5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
16325518|NCT00457106|Drug|Paroxetine|
16325519|NCT00457106|Drug|Risperidone|
16325520|NCT00457093|Drug|glargine|
16325521|NCT00457093|Drug|detemir|
16325522|NCT00457080|Device|Alaris ETCO2 monitor - cont. resp. rate, & apnea events|
16325523|NCT00457067|Drug|Ranibizumab|
16325524|NCT00457054|Drug|Lithium|starting dose 600 mg increase as tolerated
16325525|NCT00457015|Drug|ecallantide|dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
16325526|NCT00457015|Drug|Phosphate Buffer Saline (PBS), pH 7.0|given as three 1mL subcutaneous injections.
16325527|NCT00457002|Drug|Apixaban|"Apixaban: Twice daily, 30 days
~Placebo: Once daily, 6-14 days"
16325528|NCT00457002|Drug|Enoxaparin|"Enoxaparin: Once daily, 6-14 days
~Placebo: Twice daily, 30 days"
16325529|NCT00456989|Drug|Taxotere|Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.
16325530|NCT00456989|Drug|Doxil|Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
16325531|NCT00456976|Drug|Selegiline|
16325532|NCT00456963|Behavioral|Diet|total fat < 5%, saturated fat < 10%, vegetables, fruit
16325533|NCT00456963|Behavioral|Moderate exercise|30 min at least 5 times/week
16325534|NCT00456963|Drug|enalapril tablets|one Enalapril 10mg tablet once daily for four weeks. Subsequentely one Enalapril 20mg tablet once daily until the end of the randomized treatment phase
16325535|NCT00456963|Drug|placebo tablets|one Enalapril placebo tablet and one Losartan placebo tablet once daily until study end.
16325536|NCT00456963|Drug|Losartan Tablets|one Losartan 50mg tablet once daily for four weeks. Subsequentely one Losartan 100mg tablet once daily until the end of the randomized treatment phase.
16325537|NCT00456937|Drug|Escitalopram|
16325538|NCT00456924|Drug|VA2914|
16325539|NCT00456911|Behavioral|Fat and carbohydrate controlled diet|
16325540|NCT00456898|Drug|desvenlafaxine sustained release (DVS SR)|
16325541|NCT00456898|Drug|Paroxetine|
16325542|NCT00456898|Drug|Codeine|
16325543|NCT00456885|Drug|exenatide|5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
16325544|NCT00456885|Drug|Placebo|Twice daily injection of placebo
16325545|NCT00456872|Drug|lidocaine|
16325546|NCT00456859|Drug|Kremezin|
16325547|NCT00456846|Drug|ABI-007|100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest
16325548|NCT00456833|Drug|RAD001|
16325549|NCT00456833|Drug|erlotinib|
16325550|NCT00456820|Drug|Wellbutrin XL|
16325551|NCT00456807|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16325552|NCT00456807|Biological|Cervarix TM|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16325553|NCT00456794|Drug|Istradefylline (KW-6002)|
16325554|NCT00456781|Device|Augmentation|Rotator Cuff Repair plus Graft Jacket
16325555|NCT00456781|Procedure|Rotator Cuff Repair without augmentation|Rotator Cuff Repair without augmentation
16325556|NCT00456755|Drug|Shi-Bi-Lin|4 weeks of treatment, dose of 1 g (two capsules), twice daily
16325557|NCT00456755|Other|Placebo|4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
16325558|NCT00456729|Drug|Metronidazole|
16325559|NCT00456729|Procedure|Blood tests|
16325560|NCT00456716|Drug|sorafenib|400mg po bid
16325561|NCT00456703|Other|intraoperative fluid management|fluid restriction
16325562|NCT00456703|Other|fluid restriction|restriction of fluids
16325563|NCT00456690|Other|Nutritional recommendations|Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done
16325564|NCT00456677|Drug|minocycline|addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
16325565|NCT00456677|Drug|Placebos|Addition of oral placebo capsule in addition to standard of care regimen
16325566|NCT00456664|Genetic|IE gene|
16325567|NCT00456651|Device|CPAP (Continuous Positive Airway Pressure)|
16325568|NCT00456638|Drug|Depodur|Depodur vs. traditional management
16325569|NCT00456625|Biological|Engerix™-B|Intramuscular injection, 1 dose
16325570|NCT00456612|Procedure|CyberKnife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
16325571|NCT00456599|Drug|gemcitabine|Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
16325572|NCT00456599|Drug|oxaliplatin|Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
16325573|NCT00456599|Procedure|Radiation|The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
16325574|NCT00456586|Drug|KW-6002 (istradefylline)|
16325575|NCT00456573|Procedure|tonsillectomy|medically indicated tonsillectomy in subjects with and without OAS
16325576|NCT00456560|Drug|AV650|
16325577|NCT00456560|Drug|Fluvoxamine|
16325578|NCT00456560|Drug|Paroxetine|
16325579|NCT00456547|Procedure|Blood Draw|Blood was obtained for coagulation studies at 2 hours following hysterectomy or cesarean delivery.
16325580|NCT00456521|Drug|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day|
16325581|NCT00456521|Drug|Placebo|
16325582|NCT00456521|Behavioral|Intensive group lifestyle modification counseling|
16325583|NCT00456508|Drug|ecallantide|solution for SC injection, one 30 mg dose per HAE attack
16325584|NCT00456495|Drug|ranibizumab|Subconjunctival injection of drug every 2 to 4 weeks
16325585|NCT00456482|Drug|Fluocinolone Acetonide 0.59mg|Fluocinolone Acetonide Intravitreal Implant 0.59 mg
16325586|NCT00456482|Drug|Fluocinolone Acetonide 2.1mg|Fluocinolone Acetonide Intravitreal Implant 2.1 mg
16325587|NCT00456443|Procedure|Historical records|
16325588|NCT00456430|Drug|Escitalopram|10 mg a day of escitalopram by mouth per day for 4 weeks. Dose may be increased to 20 mg a day after the 4th week depending on tolerance and treatment response.
16325589|NCT00456417|Drug|123-I MNI-187 Injection and Imaging Procedures|
16325590|NCT00456404|Drug|peppermint water|
16325591|NCT00456391|Procedure|Medical history|
16325592|NCT00456391|Procedure|Brain CT scan|
16325593|NCT00456378|Device|DIAM™ Spinal Stabilization System|Surgical procedure with implantation of the Investigational device
16325594|NCT00456378|Procedure|Conservative care|Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.
16325595|NCT00456365|Drug|pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
16325596|NCT00456365|Drug|Placebo|Placebo daily
16325597|NCT00456352|Procedure|duodenal exclusion|
16325598|NCT00456339|Drug|Prednisolone and amoxicillin/clavulanate|Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
16325599|NCT00456313|Drug|FLIXOTIDE and SERETIDE|comparator
16325600|NCT00456300|Drug|Exenatide|In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
16325601|NCT00456300|Drug|Insulin|Each subject received a baseline study with insulin alone
16325602|NCT00456287|Device|CPAP (Continuous Positive Airway Pressure)|
16325603|NCT00456274|Procedure|Frequent baseline blood sampling|3 ml of blood sampled every 10 minutes for a total of 8-12 hours
16325604|NCT00456261|Drug|Pemetrexed|pemetrexed 500 mg/m2
16325605|NCT00456261|Drug|Gemcitabine|gemcitabine 1500 mg/m2
16325606|NCT00456261|Drug|Bevacizumab|bevacizumab 10mg/kg bevacizumab 15mg/kg
16325607|NCT00456261|Drug|Carboplatin|carboplatin AUC=5
16325608|NCT00456248|Drug|Infergen and ribavirin|Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
16325609|NCT00456235|Drug|Mycophénolate Mofétil|
16325610|NCT00456235|Drug|Ciclosporine A|
16325611|NCT00456235|Drug|Tacrolimus|
16325612|NCT00456222|Behavioral|Disrupting or changing the timing or the duration of sleep|Disrupting or changing the timing or the duration of sleep
16325613|NCT00456183|Biological|MVA 85A|
16325614|NCT00456170|Procedure|Performing Vaginal hysterectomy with Harmonic Scalpel|
16325615|NCT00456157|Drug|Intra-articular Injection of OP-1 to affected knee|
16325616|NCT00456144|Drug|Gonadotropin Releasing Hormone Agonist Therapy|Given either for 24 months and 6 months
16325617|NCT00456131|Behavioral|Healthy Eating Behaviors Training|The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.
16325618|NCT00456105|Behavioral|Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician|See Detailed Description.
16325619|NCT00456105|Behavioral|Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team|See detailed description.
16325620|NCT00456105|Behavioral|Subjects without diabetes will have their blood glucose levels monitored while in the hospital|See detailed description.
16325621|NCT00456092|Drug|Apremilast|Capsules for oral administration
16325622|NCT00456092|Drug|Placebo|Capsules for oral administration
16325623|NCT00456066|Device|Export Aspiration System|Patients scheduled for emergency angioplasty
16325624|NCT00456053|Drug|FG2216|
16325625|NCT00456027|Drug|rhGAD65 formulated in Alhydrogel® (Diamyd®)|20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
16325626|NCT00456014|Drug|Escitalopram|Escitalopram will be administered at a dose of 10 mg daily for 4 weeks. If participants have not achieved response (greater than 50 % improvement in Hamilton Depression Rating Scale) by 4 weeks, the dose will be increased to 20 mg. Remission status is determined after an 8-week trial.
16325627|NCT00456014|Drug|Desipramine|Subsequent to escitalopram trial, non-remitters will be offered pharmacotherapy with desipramine. Desipramine will be initiated at a dose of 50 mg and titrated according to a treatment manual, with monitoring of therapeutic blood levels. Remission status is determined after an 8-week trial.
16325628|NCT00455975|Drug|Bevacizumab|Bevacizumab
16325629|NCT00455962|Drug|Estradiol steroid infusion|Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr
16325630|NCT00455962|Drug|Progesterone steroid infusion|Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr
16325631|NCT00455936|Drug|Gefitinib|gefitinib 250mg tablet/ QD daily until Progression
16325632|NCT00455936|Procedure|chemotherapy|gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles
16325633|NCT00455923|Drug|Seretide|Seretide
16325634|NCT00455923|Drug|Flixotide|Flixotide
16325635|NCT00455910|Drug|Thalidomide|
16325636|NCT00455897|Drug|GM-CSF|Given 11 days before day 1 of cycle 1 for 10 days
16325637|NCT00455897|Drug|CHOP|Administered as part of standard care
16325638|NCT00455897|Drug|Rituximab|Administered as part of standard treatment
16325639|NCT00455871|Drug|reduced fluence photodynamic therapy with Visudyne|reduced fluence photodynamic therapy with visudyne
16325640|NCT00455871|Drug|Lucentis|Lucentis intravitreal injection
16325641|NCT00455858|Drug|insulin detemir|Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
16325642|NCT00455845|Device|Levonorgestrel IUD|levonorgestrel IUD
16325643|NCT00455832|Procedure|peginterferon alpha and ribavirin|sperm collection
16325644|NCT00455819|Procedure|home treatment|
16325645|NCT00455806|Drug|esomeprazole|
16325646|NCT00455806|Drug|moxifloxacin|
16325647|NCT00455806|Drug|amoxicillin|
16325648|NCT00455780|Behavioral|Weight Loss Phase|Weight loss using CBT and meal replacements
16325900|NCT00454168|Other|placebo|Given subcutaneously
16325649|NCT00455780|Behavioral|Continued CBT|Using CBT during weight loss maintenance
16325650|NCT00455780|Behavioral|reduced energy density education|Additional nutritional learning
16325651|NCT00455780|Behavioral|continued use of meal replacements|continued use of meal replacements during weight loss maintenance
16325652|NCT00455767|Drug|EPI-hNE4|I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
16325653|NCT00455767|Drug|Placebo|Placebo
16325654|NCT00455754|Drug|Esomeprazole|
16325655|NCT00455741|Drug|Estradiol infusion|Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.
16325656|NCT00455741|Drug|Progesterone infusion|Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study.
16325657|NCT00455715|Drug|Sildenafil|1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
16325658|NCT00455702|Drug|d-cycloserine|50mg dose d-cycloserine v placebo
16325659|NCT00455689|Drug|Leuprolide acetate|"Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection
~Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women."
16325660|NCT00455676|Procedure|Chevron osteotomy versus Scarf osteotomy|
16325661|NCT00455663|Behavioral|Cognitive Adaptation Training|Environmental supports for all independent living skills
16325662|NCT00455663|Behavioral|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
16325663|NCT00455663|Other|Treatment as usual|Medication follow-up and limited case management provided by local community mental health authority
16325664|NCT00455650|Drug|Mecamylamine|A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
16325665|NCT00455650|Drug|Varenicline|A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
16325666|NCT00455650|Drug|Placebo|The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
16325667|NCT00455637|Biological|Botulinum toxin type A|
16325668|NCT00455624|Drug|Androgen deprivation therapy|According to standard medical care
16325669|NCT00455611|Device|CPAP (Continuous Positive Airway Pressure)|
16325670|NCT00455598|Drug|ISIS 113715|doses of 100 and 200 mg per week
16325671|NCT00455585|Drug|nevirapine, stavudine, lamivudine|
16325672|NCT00455572|Biological|Immunotherapeutic GSK1572932A|Intramuscular injection, 8 doses
16325673|NCT00455572|Drug|Cisplatin (CDDP)|Four cycles with doses based on patient's body surface area, intravenous administration
16325674|NCT00455572|Drug|Vinorelbine|Four cycles with doses based on patient's body surface area , intravenous administration
16325675|NCT00455572|Procedure|Radiotherapy|Regimen will be based upon the site's own standard procedures
16325676|NCT00455559|Drug|Perifosine|
16325677|NCT00455559|Drug|Imatinib Mesylate|
16325678|NCT00455546|Drug|A-002|
16325679|NCT00455533|Drug|Ixabepilone|Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks
16325680|NCT00455533|Drug|Paclitaxel|Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks
16325681|NCT00455533|Drug|Cyclophosphamide|Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks
16325682|NCT00455533|Drug|Doxorubicin|Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
16325683|NCT00455520|Drug|CG5503|100, 150, 200, 250 mg twice daily given for up to 15 weeks
16325684|NCT00455520|Drug|placebo|matching placebo twice daily for 12 weeks
16325685|NCT00455507|Drug|Istradefylline|Two 10 mg KW-6002 tablets orally once daily for 12 weeks
16325686|NCT00455507|Drug|Istradefylline|Two 20 mg tablets orally once a day for 12 weeks
16325687|NCT00455507|Drug|Placebo|Two placebo tablets orally once daily for 12 weeks
16325688|NCT00455494|Drug|AQ-13|
16325689|NCT00455468|Procedure|Day-care treatment vs. hospital care|
16325690|NCT00455455|Drug|Optifree RepleniSH Multipurpose Disinfecting Solution|lens care system
16325691|NCT00455455|Drug|ReNu Multiplus Multipurpose Solution|lens care system
16325692|NCT00455442|Drug|Mifepristone|
16325693|NCT00455429|Drug|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.
16325694|NCT00455429|Drug|JNJ-26113100 (50 mg) once daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
16325695|NCT00455429|Drug|JNJ-26113100 (100 mg) once daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
16325696|NCT00455429|Drug|JNJ-26113100 (100 mg) twice daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
16325697|NCT00455429|Drug|JNJ-26113100 (250 mg) twice daily|JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
16325698|NCT00455416|Drug|Omega 3 fatty acids (EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid))|1000mgx5 daily
16325699|NCT00455416|Drug|Selenium (L-Selenomethionine),|100mcgx2 daily
16325700|NCT00455416|Drug|Garlic extract (Allicin)|6 garlic pearls daily
16325701|NCT00455416|Drug|Pomegranate juice (ellagic acid)|Pomegranate juice 100%, 660ml /495 ml every second day.
16325702|NCT00455416|Drug|Grape juice (resveratrol, quercetin)|Merlot grape juice 100%, 660ml /495 ml every second day
16325703|NCT00455416|Drug|Green Tea (Epigallocathechin gallate)|Green Tea. 2 cups daily
16325704|NCT00455403|Drug|Chloroquine|One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24
16325705|NCT00455403|Drug|Placebo Comparator|Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
16325706|NCT00455390|Procedure|Post-immediate Psychotherapeutic Intervention|
16325707|NCT00455364|Drug|Voriconazole|
16325708|NCT00455351|Drug|Vorinostat|Increasing dosing, phase I
16325709|NCT00455338|Behavioral|Meal Composition|
16325710|NCT00455325|Drug|Placebo Comparator Limb 1|1 chloroquine placebo tablet for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
16325711|NCT00455325|Drug|Chloroquine|80mg chloroquine or placebo tablet weekly for Weeks 1-3;euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
16325712|NCT00455325|Drug|Chloroquine|80mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
16325713|NCT00455325|Drug|Chloroquine|250mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
16325714|NCT00455312|Drug|Campath 1H|10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).
16325715|NCT00455312|Drug|Cyclophosphamide|7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).
16325716|NCT00455312|Drug|Fludarabine|6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)
16325717|NCT00455312|Procedure|Total Body Irradiation|1 day before the transplant one dose (200 cGy) of total body irradiation is given
16325718|NCT00455312|Procedure|Stem Cell Transplantation|Infusion of stem cells on Day 0.
16325719|NCT00455312|Drug|antithymocyte globulin|ATG (rabbit) 3 mg/kg for 3 days.
16325720|NCT00455312|Drug|Methylprednisolone|2mg/kg IV is given before each dose of antithymocyte globulin (ATG).
16325721|NCT00455299|Procedure|Laparoscopic ventral hernia repair|
16325722|NCT00455286|Drug|Methotrexate|
16325723|NCT00455286|Drug|Methylprednisolone|
16325724|NCT00455286|Drug|Temozolomide|
16325725|NCT00455260|Drug|hGH-ViaDerm™ System (hGH or somatropin)|transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day)
16325726|NCT00455260|Device|hGH-ViaDerm™ System|"The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin).
~The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system."
16325727|NCT00455247|Drug|Glutamine|
16325728|NCT00455234|Drug|Intramuscular Olanzepine 10 mg|
16325729|NCT00455234|Drug|Intramuscular Haloperidol 5-10 mg + Promethazine 25-50 mg|
16325730|NCT00455221|Biological|Bcr-abl multipeptide vaccine|The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial
16325731|NCT00455221|Genetic|Cytokine gene adjuvant|Cytokine gene adjuvant
16325732|NCT00455208|Drug|Cura-100|
16325733|NCT00455195|Biological|alglucosidase alfa|IV infusion of 20 mg/kg; every other week (qow)
16325734|NCT00455182|Procedure|Acupuncture|Standard medical care plus a single true acupuncture treatment.The needles are strategically inserted into the scalp, trunk, arms or legs (not near the surgical site) and manipulated. The needles are withdrawn between 5 minutes and 30 minutes after insertion.
16325735|NCT00455182|Procedure|Sham Acupuncture|Standard medical care plus sham acupuncture. A single treatment, using a maximum of 9 sham needles, which adhere to the skin but do not penetrate it. The sham needles are strategically placed on the scalp, trunk, arms or legs (not near the surgical site)
16325736|NCT00455182|Procedure|Standard medical care|Standard medical care at Woodwinds Hospital includes guided imagery, essential oils and massage.
16325737|NCT00455169|Biological|Trivalent Inactivated Influenza Vaccine|Influenza vaccine
16325738|NCT00455156|Drug|150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)|150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
16325739|NCT00455143|Drug|Precedex (Dexmedetomidine)|Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
16325740|NCT00455143|Drug|Placebo|Matching placebo given prior to surgery and continued for 24 hours postoperatively
16325741|NCT00455130|Drug|Inhaled mannitol|
16325742|NCT00455117|Drug|Intravenous Parecoxib ('Dynastat' Pfizer)|parecoxib or placebo
16325743|NCT00455104|Other|No intervention|This is an observational, voluntary registry.
16325744|NCT00455091|Drug|Adefovir Dipivoxil and Lamivudine|Adefovir Dipivoxil 10mg/day x 36 months,Lamivudine 100 mg/day x 18 months#, when HBV DNA =/> 105 copies/mL and ALT > 2.0 x UNL
16325745|NCT00455078|Procedure|esophagogastroduodenoscopy|EGD will be done pretransplant then again before 18mos post transplant.
16325746|NCT00455078|Other|Standard GER questionnaire (RDQ)|RDQ questionnaire will be done pretransplant then again before 18mos post transplant.
16325747|NCT00455078|Procedure|Scintigraphic evaluation of solid gastric emptying|Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.
16325748|NCT00455078|Procedure|Twenty-four hour ambulatory pH testing|Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
16325749|NCT00455078|Procedure|Esophageal manometry testing|Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.
16325750|NCT00455065|Behavioral|Whole Grain Foods|
16325751|NCT00455052|Drug|XMT-1001|XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.
16325752|NCT00455039|Drug|GW572016|Dose: 1500 mg daily
16325753|NCT00455026|Drug|remifentanil|target effect site concentration during induction
16325754|NCT00455013|Drug|Thymoglobulin|Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours
16325755|NCT00455013|Drug|Belatacept|Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial
16325756|NCT00455013|Drug|Sirolimus|Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter
16325757|NCT00455013|Drug|Tacrolimus|The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial
16325758|NCT00455013|Drug|Mycophenolate Mofetil (MMF)|Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
16325759|NCT00455000|Biological|PF-04360365|Monoclonal antibody
16325760|NCT00455000|Drug|Placebo|Placebo
16325761|NCT00454987|Biological|Menitorix|Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.
16325762|NCT00454987|Biological|Infanrix IPV|Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
16325763|NCT00454974|Device|Wearable artificial kidney|
16325764|NCT00454961|Drug|artemether-lumefantrine|
16325765|NCT00454948|Behavioral|Home-based nutrition sessions and play group exercise|
16325766|NCT00454948|Behavioral|Group-based nutrition sessions and mail-out activities|
16325767|NCT00454922|Behavioral|standard of care|no intervention
16325768|NCT00454922|Other|education|meet with trained glaucoma educator 6 times over life of study
16325769|NCT00454909|Biological|Meningococcal vaccine 134612|Single dose intramuscular injection.
16325770|NCT00454909|Biological|Menactra®|Single dose intramuscular injection.
16325771|NCT00454896|Drug|VESIcare®|Oral
16325772|NCT00454896|Drug|placebo|Oral
16325773|NCT00454883|Drug|ziprasidone|Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
16325774|NCT00454870|Drug|MEM 3454|
16325775|NCT00454857|Other|Retrospective Chart Review|Retrospective chart review for up to 36 months of enrollment date.
16325776|NCT00454857|Other|Patient-reported Outcome Questionnaires|Quality of lige questionnaires as well as treatment satisfaction questionnaires are required monthly. Includes QOL, ITP-PAQ (immune thrombocytopenic purpura - patient assessment questionnaire), EQ-5D, and TSQM (Treatment Satisfaction Questionnaire for Medication).
16325777|NCT00454857|Other|Physician Survey|Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.
16325778|NCT00454831|Device|HEP-40 chitosan|Enzymatically Hydrolyzed Polychitosamine-40 kDa
16325779|NCT00454818|Genetic|MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)|MYDICAR administered by antegrade epicardial coronary artery infusion
16325780|NCT00454818|Procedure|Placebo Infusion|Saline; epicardial coronary artery infusion
16325781|NCT00454818|Genetic|MYDICAR Phase 2 (Placebo-controlled, Randomized Study)|MYDICAR administered by antegrade epicardial coronary artery infusion
16325782|NCT00454805|Drug|AZD2171|Oral tablet
16325783|NCT00454805|Drug|Fulvestrant|intramuscular injection
16325784|NCT00454792|Other|Exercise|Back exercise: At home every day. In groups once a week. Duration 10 weeks.
16325785|NCT00454792|Other|Restitution|Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
16325786|NCT00454779|Drug|Cisplatin|chemotherapy arm
16325787|NCT00454779|Drug|Panitumumab|experimental arm
16325788|NCT00454779|Drug|Docetaxel|chemotherapy arm
16325789|NCT00454779|Drug|Cisplatin|experimental arm
16325790|NCT00454779|Drug|Docetaxel|experimental arm
16325791|NCT00454766|Behavioral|Questionnaire|Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
16325792|NCT00454753|Drug|Dasatinib|"tablet, Oral, 140mg/day, BID, until;
~the time of reimbursement in Korea
~the application for marketing authorization is withdrawn
~the application for marketing authorization is denied"
16325793|NCT00454740|Drug|solifenacin succinate|Oral
16325794|NCT00454714|Drug|single dose Sildenafil|Application of a single dose Sildenafil
16325795|NCT00454714|Drug|Single dose placebo|Application of a single dose placebo
16325796|NCT00454701|Drug|Alefacept exposure|Observational
16325898|NCT00454168|Biological|PR1 leukemia peptide vaccine|Given subcutaneously
16325899|NCT00454168|Biological|sargramostim|Given subcutaneously
16325797|NCT00454688|Drug|Asimadoline|Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
16325798|NCT00454688|Drug|Placebo|Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
16325799|NCT00454662|Drug|olmesartan medoxomil / amlodipine or azelnidipine|AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine
16325800|NCT00454662|Drug|olmesartan medoxomil / low dose thiazide type drug|AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug
16325801|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
16325802|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
16325803|NCT00454649|Drug|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
16325804|NCT00454649|Drug|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
16325805|NCT00454649|Drug|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
16325806|NCT00454649|Drug|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
16325807|NCT00454649|Drug|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
16325808|NCT00454649|Drug|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
16325809|NCT00454649|Drug|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
16325810|NCT00454649|Drug|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
16325811|NCT00454636|Drug|Cisplatin|80 mg/m2/day, intravenous (IV), every 3 weeks
16325812|NCT00454636|Drug|Capecitabine|1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
16325813|NCT00454636|Drug|Epirubicin|50 mg/m2/day, IV, every 3 weeks
16325814|NCT00454636|Drug|Cisplatin|60 mg/m2/day, IV, every 3 weeks
16325815|NCT00454636|Drug|Capecitabine|625 mg/m2, oral, twice daily per 3-week cycle
16325816|NCT00454636|Drug|Oxaliplatin|130 mg/m2/day, IV, every 3 weeks
16325817|NCT00454636|Drug|Docetaxel|60 mg/m2/day, IV, every 3 weeks
16325818|NCT00454636|Drug|Capecitabine|825 mg/m2, oral, twice daily for 2 weeks
16325819|NCT00454623|Behavioral|drawing serum adiponectin level|
16325820|NCT00454610|Behavioral|FLOW|
16325821|NCT00454610|Behavioral|SelfHelp|
16325822|NCT00454597|Procedure|omentectomy|surgery omentectomy
16325823|NCT00454584|Drug|CNTO 1275 45 mg|Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous
16325824|NCT00454584|Drug|CNTO 1275 90 mg|Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous
16325825|NCT00454584|Drug|Etanercept 50 mg|Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
16325826|NCT00454571|Drug|pazopanib hydrochloride|Given PO
16325827|NCT00454571|Drug|leuprolide acetate|
16325828|NCT00454571|Drug|goserelin acetate|
16325829|NCT00454558|Drug|Riociguat (Adempas, BAY63-2521)|Biweekly uptitration of BAY63-2521 (Oral sGC Stimulator) starting from 1.0 mg TID up to 2.5 mg TID in steps of +0.5 mg according to safety and tolerability.
16325830|NCT00454545|Drug|Atorvastatin|
16325831|NCT00454532|Drug|BZL101|Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.
16325832|NCT00454519|Procedure|cytoreductive surgery|the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
16325833|NCT00454519|Procedure|intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin|Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.
16325834|NCT00454493|Drug|Omacor (omega-3-acid ethyl esters)|
16325835|NCT00454480|Biological|alemtuzumab|
16325836|NCT00454480|Drug|arsenic trioxide|
16325837|NCT00454480|Drug|azacitidine|
16325838|NCT00454480|Drug|busulfan|
16325839|NCT00454480|Drug|clofarabine|
16325840|NCT00454480|Drug|cytarabine|
16325841|NCT00454480|Drug|daunorubicin hydrochloride|
16325842|NCT00454480|Drug|fludarabine phosphate|
16325843|NCT00454480|Drug|gemtuzumab ozogamicin|
16325844|NCT00454480|Drug|melphalan|
16325845|NCT00454480|Drug|tipifarnib|
16325846|NCT00454480|Genetic|DNA methylation analysis|
16325847|NCT00454480|Genetic|cytogenetic analysis|
16325848|NCT00454480|Genetic|gene expression analysis|
16325849|NCT00454480|Genetic|mutation analysis|
16325850|NCT00454480|Other|diagnostic laboratory biomarker analysis|
16325851|NCT00454480|Other|immunologic technique|
16325852|NCT00454480|Procedure|allogeneic hematopoietic stem cell transplantation|
16325853|NCT00454480|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16325854|NCT00454467|Procedure|Baseline Questionnaire|Patients will fill out a baseline questionnaire prior to surgery.
16325855|NCT00454467|Procedure|Operative Data|Type of prosthesis and other operative data will be uploaded into our database.
16325856|NCT00454467|Procedure|Intra-operative data will be collected post-operatively|Research assistants will post-operatively collect data from patient charts.
16325857|NCT00454467|Procedure|In-hospital post-operative data will be collected|Research assistants will collect information about hospital stay from patient charts.
16325858|NCT00454467|Procedure|Satisfaction data will be extracted from Press/Ganey and on follow-up questionnaires|Follow-up questionnaires will be mailed to participants.
16325859|NCT00454467|Procedure|Cost Data|Cost Data will be collected via hospital billing databases.
16325860|NCT00454467|Procedure|Follow-up questionnaires|Participants will be mailed follow-up questionnaires.
16325861|NCT00454441|Drug|MF101|
16325862|NCT00454428|Procedure|pulsatile intra-aortic balloon pump|
16325863|NCT00454402|Drug|Alfuzosin|
16325864|NCT00454389|Device|Epi-Rad90™ Ophthalmic System|A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
16325865|NCT00454389|Drug|ranibizumab|Lucentis injection administered monthly for the first 3 injections followed by quarterly injections
16325866|NCT00454376|Other|questionnaire administration|
16325867|NCT00454376|Procedure|quality-of-life assessment|
16325868|NCT00454363|Other|Laboratory Biomarker Analysis|Correlative studies
16325869|NCT00454363|Drug|Pazopanib Hydrochloride|Given PO
16325870|NCT00454363|Other|Pharmacological Study|Correlative studies
16325871|NCT00454350|Drug|Hectorol (doxercalciferol injection)|
16325872|NCT00454350|Drug|Zemplar (Paricalcitol injection)|
16325873|NCT00454337|Drug|FTC/TDF + EFV or LPV/R +T20|emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day) + enfuvirtide 90mg twice a day
16325874|NCT00454337|Drug|FTC/TDF + EFV or LPV/R|emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day)
16325875|NCT00454324|Drug|Carboplatin|Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle
16325876|NCT00454324|Drug|Abraxane|"Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
16325877|NCT00454311|Procedure|Biopsy of Day 3 Embryo|
16325878|NCT00454311|Procedure|· day embryo biopsy|
16325879|NCT00454298|Drug|AGG-523 (Aggrecanase Inhibitor)|
16325880|NCT00454285|Drug|Effect of Amoxicillin on bacteremia following a single-tooth extraction|Administer Amoxicillin 1 hour prior to single-tooth extraction.
16325881|NCT00454272|Drug|Teicoplanin|
16325882|NCT00454272|Drug|Vancomycin|
16325883|NCT00454259|Drug|Fentanyl/Placebo injection|Ultra low dose intravenous injection
16325884|NCT00454246|Drug|methoxy polyethylene glycol-epoetin beta|Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
16325885|NCT00454246|Drug|epoetin alfa|Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
16325886|NCT00454246|Drug|darbepoetin alfa|Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
16325887|NCT00454233|Drug|YM543|Oral
16325888|NCT00454233|Drug|Metformin|Oral
16325889|NCT00454233|Drug|Placebo|oral
16325890|NCT00454220|Other|Placebo|33 patients to placebo + 131-I arm
16325891|NCT00454220|Drug|MRrhTSH|33 patients to 0.01 mg MRrhTSH + 131-I arm
16325892|NCT00454220|Drug|MRrhTSH|33 patients to 0.03 mg MRrhTSH + 131-I arm
16325893|NCT00454207|Drug|sildenafil citrate (UK-92,480)|sildenafil citrate (UK-92,480)
16325894|NCT00454194|Drug|pemetrexed disodium|given IV
16325895|NCT00454194|Drug|sorafenib tosylate|given orally
16325896|NCT00454181|Drug|Interferon-alpha|500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
16325897|NCT00454181|Other|placebo|200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
16325901|NCT00454155|Drug|Opebacan|4 mg/kg continuous IV infusion for 30 minutes followed immediately by 6 mg/kg/day continuous IV infusion for 3 days
16325902|NCT00454142|Drug|pazopanib hydrochloride|Given PO
16325903|NCT00454142|Other|pharmacological study|Correlative studies
16325904|NCT00454142|Procedure|computed tomography|Correlative studies
16325905|NCT00454129|Procedure|cholangiography via double-balloon enteroscopy|
16325906|NCT00454129|Procedure|MR cholangiography|
16325907|NCT00454116|Drug|Vandetanib|once daily oral tablet two doses
16325908|NCT00454116|Drug|FOLFIRI|Intravenous infusion
16325909|NCT00454103|Drug|123I-Iodometomidate|
16325910|NCT00454090|Drug|AZD8330|oral tablet
16325911|NCT00454077|Procedure|radioiodine therapy after rhTSH|
16325912|NCT00454064|Behavioral|cognitive-behavioral treatment|
16325913|NCT00454051|Drug|Omalizumab|Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab.
16325914|NCT00454051|Drug|placebo|Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.
16325915|NCT00454038|Device|HYPRO SORB F|resorbable, double layered, collagen membrane
16325916|NCT00454012|Procedure|biophysical profile|
16325917|NCT00453999|Drug|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
16325918|NCT00453999|Drug|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
16325919|NCT00453999|Drug|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
16325920|NCT00453986|Biological|Meningococcal vaccine GSK134612|One intramuscular dose
16325921|NCT00453986|Biological|Mencevax™ACWY|One subcutaneous dose
16325922|NCT00453986|Biological|Fluarix™|One intramuscular dose
16325923|NCT00453973|Drug|peginesatide|Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
16325924|NCT00453973|Drug|peginesatide|Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
16325925|NCT00453960|Dietary Supplement|Genivis|54 mg/day daily for 6 months
16325926|NCT00453960|Drug|Norethisterone Acetate|tablets 10mg/day from day 16 to 25 of menstruation
16325927|NCT00453960|Other|placebo|tablets daily for 6 months
16325928|NCT00453947|Device|CPAP and Non Invasive Ventilation|
16325929|NCT00453934|Device|h-Patch|
16325930|NCT00453921|Drug|Methylphenidate|Dosage dependent on weight
16325931|NCT00453921|Behavioral|Memory and Attention Training|Weekly Memory and Attention Training with at home practice.
16325932|NCT00453921|Other|Placebo as both treatments|Placebo capsules and Placebo Memory and Attention Training
16325933|NCT00453908|Drug|Alfuzosin|
16325934|NCT00453895|Drug|Sunitinib|50mg Sunitinib
16325935|NCT00453882|Device|flostat (TM) System|
16325936|NCT00453869|Other|liver fibrosis evaluation|Evaluation of liver fibrosis with blood test
16325937|NCT00453856|Drug|Sulfadoxine Pyrimethamine|
16325938|NCT00453843|Device|rehabilitation robotics|sequence of intervention
16325939|NCT00453843|Procedure|Movement therapy|sequence of intervention
16325940|NCT00453830|Procedure|laparoscopic sigmoid resection|a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis
16325941|NCT00453817|Drug|ferucarbotran (iron-based MRI contrast agent)|islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation
16325942|NCT00453817|Procedure|Islet transplantation|intraportal percutaneous islet transplantation
16325943|NCT00453817|Procedure|Magnetic resonance imaging|Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)
16325944|NCT00453804|Drug|injectable naltrexone|
16325945|NCT00453804|Drug|oral naltrexone|
16325946|NCT00453791|Drug|GW805858|GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
16325947|NCT00453791|Drug|Placebo|Placebo MDI will be given to the subjects.
16325948|NCT00453778|Drug|FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)|
16325949|NCT00453765|Drug|montelukast|montelukast, 8 weeks, once daily, 10 milligrams
16325950|NCT00453765|Drug|placebo|placebo
16325951|NCT00453726|Procedure|Non invasive mechanical ventilation|
16325952|NCT00453700|Procedure|Trypanosoma cruzi serology|
16325953|NCT00453687|Drug|GSK233705|investigational drug
16325954|NCT00453661|Behavioral|Questionnaire|"Intervention Group:
~Cancer Screening Assessment (CSA) questionnaire 45-60 minutes annually for 4 years + Exit Questionnaire at end of study.
~Comparison Group:
~Exit Questionnaire only."
16325955|NCT00453661|Behavioral|Patient Navigator (PN)|Staff member, called patient navigator (PN), who assist with medical care and/or screenings, questionnaires.
16325956|NCT00453648|Other|White-fleshed sweet potatoes|
16325957|NCT00453648|Other|Orange-fleshed sweet potatoes (boiled)|
16325958|NCT00453648|Other|Orange-fleshed sweet potatoes (fried)|
16325959|NCT00453648|Other|WFSP and capsule of retinyl palmitate|
16325960|NCT00453635|Drug|Docetaxel|Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
16325961|NCT00453635|Drug|Carboplatin|Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
16325962|NCT00453635|Drug|Herceptin|Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
16325963|NCT00453635|Drug|Vinorelbine|Vinorelbine at the dose of 60mg/m^2 per os,weekly
16325964|NCT00453622|Device|Cardiac Resynchronization Therapy-Defibrillator|Implantation of a CRT-D device
16325965|NCT00453609|Drug|long-lasting injectable naltrexone|
16325966|NCT00453570|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, IM
16325967|NCT00453570|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, IM
16325968|NCT00453570|Biological|Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed|0.5 mL, IM
16325969|NCT00453557|Drug|rhGH|
16325970|NCT00453544|Other|Enhanced Consent Procedure|This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved
16325971|NCT00453544|Other|Routine Consent Procedure|This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)
16325972|NCT00453531|Procedure|Limb Ischemia|
16325973|NCT00453531|Drug|Acetylcholine|
16325974|NCT00453518|Device|FiberNet EPS used during SVG intervention.|The FiberNet EPS is indicated for use as a guide wire and embolic protection system to capture and remove embolic material produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts.
16325975|NCT00453505|Diagnostic Test|MRI|The MRI studies were conducted on a 3 or 7 Tesla MRI scanner located in the NIH Magnetic Resonance Imaging Research Facility (NMRF), under the guidelines of the FDA, NIH, and NMRF. Subjects lie down in the scanner in a comfortable position, and will be monitored by investigators in the control room. They are able to communicate with the investigators by intercom at the operating console at all times. If subjects ask to stop the experiment, they will be removed immediately from the scanner. During the scan, the subjects hear a rhythmic tapping sound caused by the switching of the gradient coil that is necessary to produce the image. They are required to wear Nonmagnetic earplugs. The scanning session lasts up to approximately 2 hours.
16325976|NCT00453505|Diagnostic Test|fMRI|The MRI studies were conducted on a 3 or 7 Tesla MRI scanner located in the NIH Magnetic Resonance Imaging Research Facility (NMRF), under the guidelines of the FDA, NIH, and NMRF. Subjects lie down in the scanner in a comfortable position, and will be monitored by investigators in the control room. They are able to communicate with the investigators by intercom at the operating console at all times. If subjects ask to stop the experiment, they will be removed immediately from the scanner. During the scan, the subjects hear a rhythmic tapping sound caused by the switching of the gradient coil that is necessary to produce the image. They are required to wear nonmagnetic earplugs. The scanning session lasts up to approximately 2 hours.
16325977|NCT00453505|Diagnostic Test|MRS|MRS was used to assess (1) local changes in neurotransmitter concentrations (ie.- GABA or glutamine/glutamate) due to stimulation or behavioral training, or (2) the relationship between baseline neurotransmitter concentrations and response to stimulation or behavioral intervention(s).
16325978|NCT00453505|Diagnostic Test|MEG|Magnetoencephalogra phy (MEG) records small magnetic field changes from resulting brain activity145,146. Up to four small coils will be attached to fiducial landmarks with adhesive stickers and tape to localize the subject s head position inside the scanner. Participants will be seated comfortably during recordings, with their head positioned inside a helmet containing magnetic field detectors. The recording may occur while participants are sitting quietly or performing a cognitive or motor behavioral task. Some subjects may be provided with ear- pieces if the task includes auditory stimuli and communicate with the experimenters throughout the session from within the MEG room.
16325979|NCT00453505|Diagnostic Test|EEG|EEG records the electrical activity of the brain. Small electrodes were either individually placed on the participant s scalp or multi-channel electrode arrays positioned using an electrode cap. The recording might have occurred while participants were sitting quietly or performing a cognitive or motor behavioral task. The electrodes were removed once the EEG was complete. A device consisting of computer hardware and digital signal processing software might have used to enable triggering of a stimulator system in response to a pre-defined EEG-signal. The device was used according to the Collaboration Agreement with University Neurology Hospital T(SqrRoot) bingen and Hertie Institute for Clinical Brain Research. The new device controls the timing of the stimuli based on pre-set parameters. Additional electrodes might have been placed on the scalp or limbs for offline removal of physiological artifacts from MEG or EEG data. Individual MEG or EEG sessions lasted up to 4 hours in length.
16325980|NCT00453492|Drug|risedronate sodium|
16325981|NCT00453479|Drug|GSK233705B|
16325982|NCT00453466|Behavioral|EBW group intervention to empower battered women|
16325983|NCT00453453|Drug|Nesiritide|Nesiritide given orally in the emergency department
16325984|NCT00453440|Procedure|Cheek swab & blood test|Cheek swab & blood test
16325985|NCT00453427|Drug|Alemtuzumab (Campath-1H)|The investigational drug is alemtuzumab (Campath-1H). It is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (> 95%) normal lymphocytes and T-cell and B-cell lymphomas. Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and anti-tumour T-cell activity.
16325986|NCT00453414|Drug|Iloprost Inhalation Solution (Ventavis)|
16325987|NCT00453401|Drug|NB-001|
16325988|NCT00453388|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
16325989|NCT00453388|Drug|Cyclophosphamide|Given IV
16325990|NCT00453388|Drug|Cyclosporine|Given IV or PO
16325991|NCT00453388|Drug|Fludarabine Phosphate|Given IV
16325992|NCT00453388|Other|Laboratory Biomarker Analysis|Correlative studies
16325993|NCT00453388|Drug|Mycophenolate Mofetil|Given PO
16325994|NCT00453388|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic stem cell transplant
16325995|NCT00453388|Radiation|Total-Body Irradiation|Undergo TBI
16326291|NCT00450983|Biological|natural killer cell therapy|
16325996|NCT00453375|Drug|BHT-3021|Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
16325997|NCT00453375|Drug|BHT-Placebo|Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
16325998|NCT00453362|Other|2-deoxy-2-[18F]fluoro-D-glucose (FDG)|FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
16325999|NCT00453362|Other|3'-deoxy-3'-[18F]fluorothymidine (FLT)|FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
16326000|NCT00453362|Drug|erlotinib HCl|Tablets taken orally 150 mg/day.
16326001|NCT00453349|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
16326002|NCT00453349|Drug|Levofloxacin & Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
16326003|NCT00453336|Drug|Porfimer Sodium|Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
16326004|NCT00453336|Procedure|Photodynamic Therapy|Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.
16326005|NCT00453323|Drug|Paclitaxel|paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
16326006|NCT00453323|Drug|Capecitabine|capecitabine 900mg/m2 bid po on day 1~14, 1 weeks rest, until disease progression
16326007|NCT00453310|Drug|sunitinib malate|
16326008|NCT00453297|Drug|MF101|
16326009|NCT00453271|Drug|NB-002|
16326010|NCT00453271|Drug|Vehicle control|
16326011|NCT00453258|Other|Eye Examination|Subjects receiving eye examination
16326012|NCT00453232|Biological|bleomycin sulfate|
16326013|NCT00453232|Biological|pegfilgrastim|
16326014|NCT00453232|Drug|cisplatin|
16326015|NCT00453232|Drug|etoposide|
16326016|NCT00453219|Procedure|Screening evaluation|A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
16326017|NCT00453219|Procedure|Meal Response|The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
16326018|NCT00453219|Genetic|Blood Collection|A blood sample will be collected and used to check for genetic markers of stress vulnerability.
16326019|NCT00453219|Procedure|Functional MRI|research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
16326020|NCT00453219|Procedure|Endocrine Assessment|research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
16326021|NCT00453206|Procedure|allogeneic bone marrow transplantation|
16326022|NCT00453206|Procedure|allogeneic hematopoietic stem cell transplantation|
16326023|NCT00453206|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16326024|NCT00453206|Procedure|peripheral blood stem cell transplantation|
16326025|NCT00453193|Drug|Pentostatin|4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
16326026|NCT00453193|Drug|Alemtuzumab|30 mg IV three times weekly
16326027|NCT00453180|Drug|N-acetylcysteine|Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.
16326028|NCT00453180|Drug|Placebo|Subjects randomized to placebo arm will receive placebo pill for duration of study.
16326029|NCT00453167|Drug|Paclitaxel|Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
16326030|NCT00453167|Drug|Gemcitabine|Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
16326031|NCT00453154|Drug|Carboplatin|Given IV
16326032|NCT00453154|Drug|Cisplatin|Given IV
16326033|NCT00453154|Drug|Etoposide|Given IV
16326034|NCT00453154|Other|Laboratory Biomarker Analysis|Correlative studies
16326035|NCT00453154|Other|Placebo Administration|Given PO
16326036|NCT00453154|Drug|Sunitinib Malate|Given PO
16326037|NCT00453141|Drug|dosing of Betamethasone|
16326038|NCT00453115|Drug|Oxaliplatin|oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression
16326039|NCT00453115|Drug|Gemcitabine|gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression
16326040|NCT00453102|Drug|Rituximab|IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
16326041|NCT00453102|Drug|Ibritumomab Tiuxetan|"IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
16326042|NCT00453089|Drug|VG101|
16326043|NCT00453076|Device|Paclitaxel eluting covered metal stent and control covered metal stent|Paclitaxel eluting covered metal stent and control covered metal stent are inserted with standard ERCP technique
16326044|NCT00453063|Drug|mometasone furoate|50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning
16326045|NCT00453063|Drug|Placebo|Two sprays in each nostril once daily in the morning
16326046|NCT00453050|Drug|imiquimod|
16326047|NCT00453050|Drug|indocyanine green solution|
16326048|NCT00453050|Other|flow cytometry|
16326049|NCT00453050|Other|immunologic technique|
16326050|NCT00453050|Other|laboratory biomarker analysis|
16326160|NCT00452218|Drug|Sorafenib|200 mg daily and dose escalated to a maximum of 400 mg twice daily
16326161|NCT00452192|Drug|Telmisartan|telmisartan 80 mg daily over 2 weeks
16326051|NCT00453037|Behavioral|structured educational program|structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program
16326052|NCT00453037|Behavioral|participation in the educational program after 6 months|Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group
16326053|NCT00453024|Procedure|Pericardial graft & tissue glue|
16326054|NCT00453024|Procedure|scleral flap & sutures|
16326055|NCT00453011|Device|posterior chamber intraocular lens|
16326056|NCT00453011|Device|anterior chamber intraocular lens|
16326057|NCT00452998|Procedure|Q-switched fd Nd:yag in Laser Iridotomy|
16326058|NCT00452985|Drug|Docetaxel|60-75 mg/m²
16326059|NCT00452985|Drug|Carboplatin|AUC 5
16326060|NCT00452972|Drug|Spinal Anesthesia|
16326061|NCT00452920|Drug|docetaxel|
16326062|NCT00452920|Radiation|cesium Cs 137|
16326063|NCT00452920|Radiation|radiation therapy|
16326064|NCT00452907|Drug|Artesunate|oad, per os, 3 days of treatment
16326065|NCT00452907|Drug|Artesunate + Sulfadoxine-Pyrimethamine|oad, per os
16326066|NCT00452907|Drug|arthemether + lumefantrine|bid, per os. Duration of treatment: 3 days
16326067|NCT00452894|Drug|varenicline tartrate|
16326068|NCT00452881|Drug|gemcitabine|Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
16326069|NCT00452881|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
16326070|NCT00452881|Drug|Cisplatin|Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
16326071|NCT00452868|Drug|Donepezil|Donepezil 5 milligrams a day for 6 weeks
16326072|NCT00452855|Procedure|Sevoflurane-remifentanil anaesthesia|
16326073|NCT00452829|Drug|Folic Acid and inositol|Folic Acid and inositol
16326074|NCT00452829|Drug|Folic acid and placebo|Folic acid and placebo
16326075|NCT00452816|Behavioral|Workplace Solutions Consulting approach|"Consulting process includes:
~baseline measure of best practices
~gap analysis and recommendations reporting
~delivery of solution set toolkits for each practice chosen for implementation"
16326076|NCT00452816|Behavioral|Delayed intervention|Abbreviated version of the Workplace Solutions Consulting process applied in the intervention group
16326077|NCT00452803|Drug|chemotherapy|Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
16326078|NCT00452803|Drug|Concurrent chemoradiation therapy|Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
16326079|NCT00452803|Radiation|Concurrent chemoradiation therapy|Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx
16326080|NCT00452790|Biological|13-valent Pneumococcal Conjugate Vaccine|1 dose at 6, 10, 14 weeks and 12 months of age
16326081|NCT00452790|Biological|7 valent pneumococcal conjugate vaccine|1 dose at 6, 10, 14 weeks and 12 months of age
16326082|NCT00452777|Drug|BVT.115959|
16326083|NCT00452777|Drug|Placebo|
16326084|NCT00452764|Behavioral|Withdrawal of medication|
16326085|NCT00452751|Procedure|laparoscopy-assisted distal gastrectomy|
16326086|NCT00452751|Procedure|open distal gastrectomy|
16326087|NCT00452738|Behavioral|Therapy dog|
16326088|NCT00452738|Behavioral|Costumed character|
16326089|NCT00452738|Behavioral|Parents-only|
16326090|NCT00452725|Drug|MAXOMAT ®, biosynthetic growth hormone|2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration
16326091|NCT00452712|Procedure|All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing.|
16326092|NCT00452699|Drug|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
16326093|NCT00452699|Drug|Fluticasone propionate 250 mcg BID|Fluticasone propionate 250 mcg BID
16326094|NCT00452686|Biological|Boostrix|
16326095|NCT00452686|Biological|Chinese DT vaccine|
16326096|NCT00452673|Drug|Dasatinib|Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
16326097|NCT00452673|Drug|Capecitabine|Tablets, Oral, 660 - 1250 mg/m^2 twice a day (BID). Treatment may continue until disease progression.
16326098|NCT00452660|Drug|Exjade|
16326099|NCT00452634|Drug|Irinotecan|Irinotecan 65mg/m2/iv over 90min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.
16326100|NCT00452634|Drug|Cisplatin|Cisplatin 30mg/m2/iv over 30min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.
16326101|NCT00452634|Drug|Simvastatin|simvastatin 40mg/QD, PO, daily, every 3 weeks
16326102|NCT00452621|Procedure|blood draw|
16326103|NCT00452608|Drug|amido pill|one pill of amido/d by mouth for 10 days
16326104|NCT00452608|Drug|atorvastatina|atorvastatina 80 mg/day by mouth for 10 days
16326105|NCT00452595|Drug|DVS-233 SR (desvenlafaxine sustained release )|
16326106|NCT00452582|Drug|Sildenafil (Viagra)|Dose escalation (one of the following): 25 mg daily for 2 weeks, 50 mg daily for 2 weeks, 75 mg daily for 2 weeks, 50 mg twice daily for two weeks, 50 mg AM and 75 mg PM for 2 weeks, 75 mg twice daily for 2 weeks, 75 mg in AM and 100 mg in PM for 2 weeks, 100 mg twice daily for 2 weeks.
16326107|NCT00452582|Other|Usual care|Physical therapy, occupational therapy, speech therapy
16326108|NCT00452569|Drug|Thalidomide|Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days).
16326109|NCT00452569|Drug|Dexamethasone|High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
16326110|NCT00452556|Drug|Docetaxel|Weekly
16326111|NCT00452556|Drug|Leuprolide Acetate (Eligard®)|2.5 years
16326162|NCT00452179|Drug|APD125|
16326163|NCT00452166|Drug|rosiglitazone|
16326112|NCT00452556|Radiation|Intensity-Modulated Radiotherapy|Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
16326113|NCT00452556|Radiation|Intensity-Modulated Radiotherapy|Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first
16326114|NCT00452543|Drug|acamprosate|Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.
16326115|NCT00452543|Drug|escitalopram|Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.
16326116|NCT00452543|Behavioral|Medical management|Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
16326117|NCT00452543|Drug|Placebo|Placebo, 2 capsules PO TID, for 12 weeks
16326118|NCT00452530|Drug|Enoxaparin|40 mg, administered once daily by subcutaneous injection, for 12 days
16326119|NCT00452530|Drug|Apixaban|2.5 mg, administered twice daily as tablets, for 12 days
16326120|NCT00452530|Drug|Enoxaparin-matching placebo|Administered once daily by subcutaneous injection
16326121|NCT00452530|Drug|Apixaban-matching placebo|Oral tablet administered twice daily
16326122|NCT00452517|Procedure|Percutaneous Coronary Intervention|
16326123|NCT00452504|Drug|SRA-444|
16326124|NCT00452491|Drug|somatropin|0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years
16326125|NCT00452491|Drug|somatropin|0.2 IU/kg/day 7 days per week given continuously for 3 years
16326126|NCT00452478|Drug|Lanthanum carbonate|2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
16326127|NCT00452465|Behavioral|ElderCare Plan|Nursing assessment and development of an appropriate care plan.
16326128|NCT00452452|Biological|13-valent Pneumococcal Conjugate Vaccine|
16326129|NCT00452439|Drug|Actonel (Risedronate)|35 mg (pill) by mouth weekly
16326130|NCT00452439|Dietary Supplement|Calcium|500 mg by mouth twice a day for a total of 24 months.
16326131|NCT00452439|Dietary Supplement|Vitamin D|400 IU by mouth twice a day for a total of 24 months.
16326132|NCT00452426|Device|Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)|propofol sedation per device instructions for use
16326133|NCT00452426|Other|benzodiazepines and opioid sedation|per site's current standard of care
16326134|NCT00452413|Drug|enzastaurin|Administered orally
16326135|NCT00452413|Drug|erlotinib|Administered orally
16326136|NCT00452400|Drug|BI 1744CL|
16326137|NCT00452387|Drug|Mitoxantrone|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Mitoxantrone 9mg/m2
~Dose Level -1 Mitoxantrone 12mg/m2
~Dose Level 1 Mitoxantrone 12mg/m2"
16326138|NCT00452387|Drug|Prednisone|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Prednisone 5mg bid
~Dose Level -1 Prednisone 5mg bid
~Dose Level 1 Prednisone 5mg bid"
16326139|NCT00452387|Drug|Sorafenib|"Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion.
~Dose Level -2, Sorafenib 400 mg QD
~Dose Level -1 Sorafenib 400 mg QD
~Dose Level 1 Sorafenib 400 mg bid"
16326140|NCT00452374|Drug|Cytarabine|1 g/m^2 given IV for two days (Days 2 and 3).
16326141|NCT00452374|Drug|Fludarabine|30 mg/m^2 given IV for two days (Days 2 and 3).
16326142|NCT00452374|Drug|Oxaliplatin|Starting dose of 17.5 mg/m^2 IV for 4 days (Days 1 through 4).
16326143|NCT00452374|Drug|Rituximab|375 mg/m^2 IV on Day 3 of the first cycle over 4-6 hours and on Day 1 on every cycle following.
16326144|NCT00452361|Drug|Sirolimus+MMF or MPS or AZA+Steroid|Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
16326145|NCT00452361|Drug|Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid|"The maintenance dose of:
~MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
~AZA will not exceed 75 mg/day
~Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:
~continued for the entire 104-week period of randomized therapy
~subsequently discontinued
~restarted after discontinuation"
16326146|NCT00452348|Drug|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID|Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
16326147|NCT00452348|Drug|Fluticasone propionate 250 mcg BID|Fluticasone propionate 250 mcg BID
16326148|NCT00452335|Drug|Lubiprostone|12 mcg capsule once daily (QD)
16326149|NCT00452335|Drug|Lubiprostone|12 mcg capsule twice daily (BID)
16326150|NCT00452335|Drug|Lubiprostone|24 mcg capsule twice daily (BID)
16326151|NCT00452322|Drug|Testosterone Substitution by Testosterone Undecanoate i.m.|
16326152|NCT00452296|Drug|tight insulin treatment in patients hospitalized with COPD exacerbation|treatment with basal plus bolus insulin
16326153|NCT00452296|Procedure|tight glycemic control|treatment with basal and bolus insulin
16326154|NCT00452270|Drug|Xylometazoline|
16326155|NCT00452257|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease
16326156|NCT00452244|Drug|simvastatin|Simvastatin 40mg/QD po daily every 3 weeks
16326157|NCT00452244|Drug|gefitinib only|gefitinib 250mg/QD po daily every 3 weeks
16326158|NCT00452231|Drug|D-cycloserine|
16326159|NCT00452231|Behavioral|Cognitive-Behavioral Therapy|
16326164|NCT00452153|Procedure|Characterization Legionnella|"Characterisation Legionnella by polymerase chain reaction (PCR)
~Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region"
16326165|NCT00452140|Biological|ertumaxomab|10 µg, IV on day 0 followed by 100 µg every 7 days up to a maximum of 12 infusions.
16326166|NCT00452127|Drug|PRO131921|Escalating doses by IV infusion
16326167|NCT00452114|Device|In-Exsufflator Cough Assist Device|
16326168|NCT00452114|Device|Active Comparator: Flutter Valve Device|Active Comparator
16326169|NCT00452101|Drug|Aquamin F|
16326170|NCT00452088|Biological|MSP 3 Long Synthetic Peptide|Lyophilized vaccine given at 15 or 30 microgrammes
16326171|NCT00452088|Biological|Hepatitis B vaccine|Hepatitis vaccine adjuvanted in Aluminium hydroxide
16326172|NCT00452088|Biological|Hepatitis B control vaccince|Hepatitis B vaccine adjuvanted in Aluminium hydroxide
16326173|NCT00452075|Drug|erlotinib|150mg daily
16326174|NCT00452062|Drug|Dexamethasone|
16326175|NCT00452049|Procedure|parathyroidectomy|parathyroidectomy
16326176|NCT00452023|Drug|IFN-alpha2a|Starting dose 90 microgram (mcg) injection under the skin once a week
16326177|NCT00452010|Device|CEFAR PRIMO TENS Class IIA (active)|Active TENS. 4 sessions per day during 3 months.
16326178|NCT00452010|Device|CEFAR PRIMO TENS Class IIA (no active)|Placebo TENS. 4 sessions per day during 3 months.
16326179|NCT00451997|Drug|Gleevec|600 mg (capsules) by mouth once daily
16326180|NCT00451997|Drug|Ara-C|10 mg as an injection under the skin daily for 21 days of every 28 day cycle
16326181|NCT00451984|Biological|Twinrix|
16326182|NCT00451984|Biological|interleukin-2|
16326183|NCT00451971|Drug|LEFLUNOMIDE|
16326184|NCT00451958|Drug|Degarelix 80 mg / Degarelix 80 mg|
16326185|NCT00451958|Drug|Degarelix 160 mg / Degarelix 160 mg|
16326186|NCT00451958|Drug|Leuprolide 7.5 mg / Degarelix 80 mg|
16326187|NCT00451958|Drug|Leuprolide 7.5 mg / Degarelix 160 mg|
16326188|NCT00451945|Procedure|biopsy|
16326189|NCT00451945|Device|3d-ultrasound and fusion of UL and PET/CT|
16326190|NCT00451932|Drug|FK778|
16326191|NCT00451906|Drug|Platinum-based chemotherapy|As prescribed
16326192|NCT00451906|Drug|Bevacizumab [Avastin]|15 mg/kg IV on Day 1 of each 3 week cycle
16326193|NCT00451893|Procedure|Lichtenstein operation with a heavy-weight mesh|Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
16326194|NCT00451893|Procedure|Lichtenstein operation with a light-weight mesh|Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
16326195|NCT00451880|Drug|XL281|Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
16326196|NCT00451880|Drug|famotidine|single dose, supplied as 20-mg or 40-mg tablets
16326197|NCT00451867|Drug|Mycophenolate Mofetil|
16326198|NCT00451867|Drug|Mycofenolate Mofetil (MMF)|2000 mg per day divided into 2 equal doses.
16326199|NCT00451867|Drug|Placebo|Placebo
16326200|NCT00451854|Procedure|Random, no advanced notice drug and alcohol testing|
16326201|NCT00451841|Device|RTube Exhaled Breath Condensate Collection System|Subjects breath through the device to collect exhaled breath condensate
16326202|NCT00451828|Drug|Simvastatin|40mg/day
16326203|NCT00451815|Drug|active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.|
16326204|NCT00451815|Drug|placebo|
16326205|NCT00451776|Drug|etomidate|patients who received etomidate
16326206|NCT00451776|Drug|propofol|patients who received propofol
16326207|NCT00451763|Drug|Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)|
16326208|NCT00451750|Drug|Cortisol|20 mg for 3 times
16326209|NCT00451737|Device|Isokinetic test|
16326210|NCT00451724|Drug|Intranasal ketamine|
16326211|NCT00451711|Drug|Liposomal amphotericin B|
16326212|NCT00451698|Drug|acyanotic erythropoietin|Single dose IV push
16326213|NCT00451698|Drug|acyanotic placebo|Single dose IV push
16326214|NCT00451672|Drug|bromocriptine|
16326215|NCT00451646|Drug|SMOF lipid and Intralipid|1-2 g, 5-7 days, 28 days
16326216|NCT00451633|Drug|E2007|
16326217|NCT00451620|Drug|glyburide|Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
16326218|NCT00451620|Drug|GlucoNorm|Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
16326219|NCT00451594|Drug|Dexamethasone|"Pulse high dose dexamethasone (Arm 1)
~Patients will receive 40 mg of oral dexamethasone daily for four consecutive days.
~Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14
~If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given.
~If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering.
~Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments."
16326220|NCT00451594|Drug|Prednisolone|"Conventional dose prednisone (Arm 2)
~Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter.
~Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months"
16326221|NCT00451581|Procedure|Endoscopic papillary balloon dilation-5 minutes|
16326222|NCT00451581|Procedure|Endoscopic papillary balloon dilation-1 minute|
16326223|NCT00451568|Drug|Metformin|500 mg 2 tablets 2 times a day
16326224|NCT00451568|Drug|Desorelle|1 tablet/day in 21 days
16326290|NCT00450983|Biological|muromonab-CD3|
16326225|NCT00451555|Drug|enzastaurin|1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
16326226|NCT00451555|Drug|placebo|oral, daily
16326227|NCT00451555|Drug|fulvestrant|500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
16326228|NCT00451516|Drug|Herbal medicine (St. John's wort and Kava)|
16326229|NCT00451503|Device|Middle Ear Implant|surgery
16326230|NCT00451490|Drug|Agomelatine|
16326231|NCT00451490|Drug|Fluoxentine|
16326232|NCT00451451|Drug|BG00012|
16326233|NCT00451451|Drug|Placebo|
16326234|NCT00451451|Drug|Glatiramer Acetate|
16326235|NCT00451425|Behavioral|motivational intervention in pregnancy|Motivational program including individualized counseling on diet and physical activity
16326236|NCT00451412|Drug|Certoparin|3000 U anti XA of certoparin in 0.3 ml solution, once daily
16326237|NCT00451412|Drug|Unfractionated Heparin|solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
16326238|NCT00451399|Drug|metformin|
16326239|NCT00451399|Behavioral|lifestyle intervention|
16326240|NCT00451386|Drug|MK0826, ertapenem sodium /Duration of Treatment: 14 Days|
16326241|NCT00451386|Drug|Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days|
16326242|NCT00451373|Device|CVVH and SLED|
16326243|NCT00451373|Drug|Vancomycin|
16326244|NCT00451373|Drug|Daptomycin|
16326245|NCT00451373|Device|FX60, AV600 (dialyzer)|
16326246|NCT00451360|Drug|diacerein|
16326247|NCT00451347|Device|Quadriceps strength training|
16326248|NCT00451347|Device|Taping|
16326249|NCT00451347|Device|Home exercise|
16326250|NCT00451321|Drug|Otelixizumab|Infusion
16326251|NCT00451308|Procedure|Induction of labor with foley balloon - 60cc of saline|60 cc of fluid
16326252|NCT00451308|Procedure|Induction of labor with foley balloon with 30cc|30cc of saline in foley
16326253|NCT00451295|Drug|MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
16326254|NCT00451295|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
16326255|NCT00451282|Behavioral|stepped preventive care|2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
16326256|NCT00451269|Device|Rapid diagnosis test for malaria|Rapid diagnosis test for malaria
16326257|NCT00451256|Drug|AVI-5126|
16326258|NCT00451230|Drug|cocaine|
16326259|NCT00451230|Drug|hydrocortisone|
16326260|NCT00451217|Drug|Sugammadex|After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
16326261|NCT00451217|Drug|Neostigmine|After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
16326262|NCT00451204|Drug|Estriol|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
16326263|NCT00451204|Drug|Placebo|Placebo capsule, once a day, treatment duration is 2 years
16326264|NCT00451204|Drug|Copaxone|Injection, once a day, all subjects
16326265|NCT00451191|Drug|botulinum toxin type A (BoNT/A)|100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
16326266|NCT00451178|Drug|enzastaurin|1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
16326267|NCT00451178|Drug|rituximab|375 milligrams per square meter (mg/m^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
16326268|NCT00451178|Drug|cyclophosphamide|750 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
16326269|NCT00451178|Drug|doxorubicin|50 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
16326270|NCT00451178|Drug|vincristine|1.4 mg/m^2, IV, Day 1 every 21 days, six 21-day cycles
16326271|NCT00451178|Drug|prednisone|100 mg, oral, Days 1-5, six 21-day cycles
16326272|NCT00451165|Procedure|laparoscopic colorectal surgery|laparoscopic colorectal surgery
16326273|NCT00451152|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.
16326274|NCT00451152|Other|Anecortave Acetate Vehicle|Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.
16326275|NCT00451139|Drug|artemether/lumefantrine|
16326276|NCT00451139|Drug|quinine|
16326277|NCT00451139|Drug|atovaquone/proguanil|
16326278|NCT00451113|Drug|Sitagliptin 100 mg|All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.
16326279|NCT00451100|Drug|Sugammadex|Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered
16326280|NCT00451100|Drug|neostigmine|Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered
16326281|NCT00451087|Procedure|leg press training|quadriceps muscle strengthening. 30min/ 3times/ week
16326282|NCT00451087|Procedure|isokinetic training|quadriceps muscle training. 30 min/ 3 times/ week
16326283|NCT00451074|Drug|Gentamicin infusions twice a week for six months|Gentamicin infusions twice a week
16326284|NCT00451061|Drug|Alfuzosin|
16326285|NCT00451061|Drug|Tamsulosin|
16326286|NCT00451048|Drug|sunitinib malate|Given orally
16326287|NCT00451035|Drug|LBH589|
16326288|NCT00451009|Device|Viacell's product Media Kits|
16326289|NCT00450996|Drug|Topical Steroids|
16326749|NCT00447980|Drug|NT-501|Low Dose
16326292|NCT00450983|Drug|fludarabine phosphate|
16326293|NCT00450983|Drug|methotrexate|
16326294|NCT00450983|Drug|thiotepa|
16326295|NCT00450983|Genetic|gene expression analysis|
16326296|NCT00450983|Other|flow cytometry|
16326297|NCT00450983|Other|immunologic technique|
16326298|NCT00450983|Procedure|allogeneic hematopoietic stem cell transplantation|
16326299|NCT00450983|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16326300|NCT00450983|Radiation|total-body irradiation|
16326301|NCT00450970|Drug|Oral Satraplatin|The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.
16326302|NCT00450957|Dietary Supplement|lycopene|Given orally
16326303|NCT00450957|Other|pharmacological study|Correlative studies
16326304|NCT00450944|Biological|deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins|
16326305|NCT00450931|Other|counseling intervention|
16326306|NCT00450931|Other|educational intervention|
16326307|NCT00450905|Device|PRIMA Device|
16326308|NCT00450892|Drug|docetaxel+lapatinib|3 cycles of docetaxel (100 mg/m²) + lapatinib (1000 mg/d) followed by 3 cycles of FEC
16326309|NCT00450892|Drug|docetaxel + trastuzumab|3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule followed by 3 cycles of FEC 100
16326310|NCT00450892|Drug|docetaxel + trastuzumab + lapatinib|"3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule
~+lapatinib (1000 mg/d) followed by 3 cycles of FEC 100"
16326311|NCT00450879|Drug|Pazopanib Hydrochloride|Given PO
16326312|NCT00450879|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
16326313|NCT00450879|Other|Pharmacological Study|Correlative studies
16326314|NCT00450879|Other|Laboratory Biomarker Analysis|Correlative studies
16326315|NCT00450866|Biological|epothilone B|Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
16326316|NCT00450853|Drug|granisetron|Granisetron SC followed by granisetron IV
16326317|NCT00450840|Drug|Simvastatin|
16326318|NCT00450827|Biological|bevacizumab|
16326319|NCT00450827|Biological|filgrastim|
16326320|NCT00450827|Procedure|autologous hematopoietic stem cell transplantation|
16326321|NCT00450827|Radiation|iodine I 131 monoclonal antibody 3F8|
16326322|NCT00450814|Drug|Cyclophosphamide|Given IV
16326323|NCT00450814|Other|Laboratory Biomarker Analysis|Correlative studies
16326324|NCT00450814|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given IV
16326325|NCT00450814|Other|Pharmacological Study|Correlative studies
16326326|NCT00450801|Drug|Rituximab|Rituximab 375 mg/m2 IV, Days 1 of all cycles
16326327|NCT00450801|Drug|Cyclophosphamide|Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.
16326328|NCT00450801|Drug|Cytarabine|Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
16326329|NCT00450801|Drug|Doxorubicin|Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
16326330|NCT00450801|Drug|Etoposide|Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
16326331|NCT00450801|Drug|Ifosfamide|Ifosfamide 1.5 grams/m2 IV once a day (QD) x 5 days, Cycles 2 and 4
16326332|NCT00450801|Drug|Leucovorin|Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.
16326333|NCT00450801|Drug|Methotrexate|Methotrexate 1,200 mg/m2 in 250 cc 5 percent dextrose in water (D5W) IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.
16326334|NCT00450801|Drug|Thalidomide|Maintenance therapy.
16326335|NCT00450801|Drug|Vincristine|Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
16326336|NCT00450801|Drug|Mesna|Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
16326337|NCT00450801|Drug|Filgrastim (G-CSF)|G-CSF 480 mcg subcutaneous (SQ) starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
16326338|NCT00450801|Drug|Granisetron|Granisetron 1 mg IV on Day 1, Cycle 1 and 3
16326339|NCT00450801|Drug|Decadron|Decadron 10 mg IV on Day 1, Cycles 1 and 3
16326340|NCT00450775|Drug|Dermatix Q|Dermatix Q applied twice daily
16326341|NCT00450762|Drug|gemcitabine|
16326342|NCT00450762|Drug|carboplatin|
16326343|NCT00450749|Other|placebo|Given PO
16326344|NCT00450749|Procedure|therapeutic conventional surgery|Undergo radical prostatectomy
16326345|NCT00450749|Other|laboratory biomarker analysis|Correlative studies
16326346|NCT00450749|Drug|lycopene|Given PO
16326347|NCT00450736|Drug|celecoxib|
16326348|NCT00450736|Procedure|adjuvant therapy|
16326349|NCT00450736|Radiation|radiation therapy|
16326350|NCT00450723|Drug|Isosulfan blue|Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
16326351|NCT00450723|Procedure|Axillary Lymph Node Dissection|Axillary Lymph Node Dissection
16326352|NCT00450723|Procedure|Surgery|The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
16326353|NCT00450723|Procedure|Sentinel Lymph Node Biopsy|Sentinel Lymph Node Biopsy
16326354|NCT00450723|Procedure|Thoracoscopic Surgery|Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
16326355|NCT00450723|Radiation|Technetium Tc 99m Sulfur Colloid|Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots
16326356|NCT00450710|Procedure|ileal interposition with a sleeve gastrectomy|
16326357|NCT00450684|Device|Implantation and testing of CRT|Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON).
16326358|NCT00450684|Device|Implantation and testing of CRT|Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).
16326359|NCT00450671|Procedure|Collagen Plug Placement|
16326360|NCT00450671|Procedure|Seton placement|
16326361|NCT00450658|Drug|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
16326362|NCT00450658|Drug|Ibuprofen|Ibuprofen 800mg orally 3 times daily for 24 weeks
16326363|NCT00450645|Drug|low molecular weight heparin|LMWH were continued for additional 6 months after detection of residual vein thrombosis (6 months after the index deep vein thrombosis) in patients randomized to group A. LMWH are stopped in patients randomized to group B or in those patients without residual vein thrombosis after 6 months from the index DVT. Dosage of LMWH are 75% of the therapeutic dosage (almost 1 mg/Kg every 12 hours)
16326364|NCT00450619|Radiation|Samarium Sm 153 lexidronam pentasodium|1 mCi/Kg given intravenous (IV)over 1 minute on day 8.
16326365|NCT00450619|Biological|Sargramostim|100 mcg/injection x 4 days given subcutaneously
16326366|NCT00450619|Biological|Recombinant vaccinia-TRICOM vaccine|2 x 10^8 PFU given subcutaneously on day 1.
16326367|NCT00450619|Biological|Recombinant fowlpox-TRICOM vaccine|1 x 10^9 PFU given subcutaneously on days 15 and 29
16326368|NCT00450606|Procedure|Balneotherapy and hydrotherapy|
16326369|NCT00450593|Genetic|gene expression analysis|
16326370|NCT00450593|Genetic|microarray analysis|
16326371|NCT00450593|Genetic|molecular genetic technique|
16326372|NCT00450593|Genetic|mutation analysis|
16326373|NCT00450593|Other|laboratory biomarker analysis|
16326374|NCT00450593|Procedure|mutation carrier screening|
16326375|NCT00450593|Procedure|study of high risk factors|
16326376|NCT00450580|Drug|fosamprenavir/ritonavir|Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent
16326377|NCT00450567|Procedure|computed tomography|
16326378|NCT00450567|Procedure|positron emission tomography|
16326379|NCT00450567|Radiation|fludeoxyglucose F 18|
16326380|NCT00450541|Behavioral|Questionnaire|Four questionnaires taking 15-20 minutes total to complete.
16326381|NCT00450541|Behavioral|Interview|Interview lasting about 30 minutes.
16326382|NCT00450515|Drug|capecitabine|
16326383|NCT00450515|Drug|vinflunine|
16326384|NCT00450502|Drug|Batracylin|
16326385|NCT00450476|Device|Hi-Lo Evac Endotracheal Tube|
16326386|NCT00450463|Drug|Sargramostim (GM-CSF, Leukine)|A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae). Sargramostim is a 127 amino acid glycoprotein, altered from the native, natural human GM-CSF molecule; the position 23 arginine has been replaced with a leucine to facilitate the expression of the protein in yeast.
16326387|NCT00450463|Drug|Flutamide (Eulexin)|Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex.
16326388|NCT00450463|Biological|PROSTVAC-F/ TRICOM|A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three costimulatory molecules.
16326389|NCT00450463|Biological|PROSTVAC-V/TRICOM|A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.
16326390|NCT00450450|Procedure|allogeneic bone marrow transplantation|Patients undergo allogeneic BMT
16326391|NCT00450450|Other|laboratory biomarker analysis|Correlative studies
16326392|NCT00450450|Biological|filgrastim|Given IV
16326393|NCT00450437|Biological|MenACWY CRM|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
16326394|NCT00450437|Biological|Meningococcal ACWY Conjugate vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
16326395|NCT00450424|Other|counseling intervention|Participants in the Counseling intervention will meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
16326396|NCT00450424|Other|CD-ROM intervention|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
16326397|NCT00450411|Radiation|125-Iodine|Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
16326398|NCT00450411|Radiation|103-palladium|Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
16326399|NCT00450398|Drug|YSPSL|YSPSL administered as an ex vivo flush (20 mg YSPSL in Viaspan® 200 mL total volume) into the portal vein prior to transplant at the back table; YSPSL 1 mg/kg administered IV to the transplant recipient prior to arterial reperfusion of the liver.
16326400|NCT00450398|Drug|Placebo|Ex vivo flush of placebo control (200 mL Viaspan®) into the portal vein prior to transplant and 0.1 mL/kg placebo control (saline) IV to the transplant recipient prior to arterial reperfusion of the liver.
16326401|NCT00450385|Drug|Rituximab|Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
16326402|NCT00450385|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
16326403|NCT00450385|Drug|Doxorubicin|Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
16326404|NCT00450385|Drug|Prednisone|Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
16326405|NCT00450385|Drug|Vincristine|Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
16326406|NCT00450372|Biological|ADI-PEG-20|There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.
16326407|NCT00450372|Other|Pharmacology Studies|tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue
16326408|NCT00450359|Procedure|breast imaging study|
16326409|NCT00450359|Procedure|comparison of screening methods|
16326410|NCT00450359|Procedure|radiomammography|
16326411|NCT00450333|Drug|Dynepo (Epoetin delta)|subcutaneous, BIW for 24 weeks
16326412|NCT00450333|Drug|Dynepo|subcutaneous, QW for 24 weeks
16326413|NCT00450333|Drug|Dynepo|subcutaneous, QW for 24 weeks
16326414|NCT00450333|Drug|Dynepo|subcutaneous, Q2W for 24 weeks
16326415|NCT00450320|Drug|sirolimus|The target rapamycin trough level will be 5-10 ng/mL. The initial dose will be dependent upon the type of HAART regimen. Subjects will continue on study protocol for six cycles as long as their KS is stable or continuing to respond to study medication. Treatment will be extended for up to six additional cycles if the subject has met criteria for a response. Subjects with no more than stable disease will have treatment discontinued after six cycles. Protocol treatment will be discontinued if the subject develops tumor progression, unacceptable toxicity or develops one of the protocol-defined reasons for treatment discontinuation at any time during the study.
16326416|NCT00450307|Biological|monoclonal antibody 3F8|
16326417|NCT00450307|Biological|sargramostim|
16326418|NCT00450281|Genetic|chromogenic in situ hybridization|
16326419|NCT00450281|Genetic|gene expression analysis|
16326420|NCT00450281|Genetic|mutation analysis|
16326421|NCT00450281|Genetic|polymerase chain reaction|
16326422|NCT00450281|Genetic|polymorphism analysis|
16326423|NCT00450281|Other|fluorescent antibody technique|
16326424|NCT00450281|Other|immunohistochemistry staining method|
16326425|NCT00450281|Other|laboratory biomarker analysis|
16326426|NCT00450281|Other|matrix-assisted laser desorption/ionization time of flight mass spectrometry|
16326427|NCT00450281|Other|study of socioeconomic and demographic variables|
16326428|NCT00450281|Procedure|study of high risk factors|
16326429|NCT00450268|Procedure|blood draw, skin shave biopsy|
16326430|NCT00450255|Biological|ziv-aflibercept|Given IV
16326431|NCT00450255|Other|pharmacological study|Correlative studies
16326432|NCT00450242|Drug|5% topical lidocaine ointment|Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
16326433|NCT00450242|Drug|Placebo cream|hydrophilic petrolatum, dime-sized amount, applied nightly.
16326434|NCT00450229|Drug|diindolylmethane|Given PO
16326435|NCT00450229|Drug|placebo|Given PO
16326436|NCT00450229|Procedure|therapeutic conventional surgery|Undergo surgical resection
16326437|NCT00450229|Other|laboratory biomarker analysis|Correlative studies
16326438|NCT00450229|Other|pharmacological study|Correlative studies
16326439|NCT00450216|Drug|Ibuprofen/famotidine|HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks
16326440|NCT00450216|Drug|Ibuprofen|Ibuprofen 800mg administered orally 3 times daily for 24 weeks
16326441|NCT00450203|Biological|bevacizumab|7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.
16326442|NCT00450203|Drug|capecitabine|dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)
16326443|NCT00450203|Drug|cisplatin|60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
16326444|NCT00450203|Drug|Epirubicin|50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
16326445|NCT00450203|Procedure|adjuvant therapy|3 cycles of ECX chemotherapy post operatively
16326446|NCT00450203|Procedure|conventional surgery|Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.
16326447|NCT00450203|Procedure|neoadjuvant therapy|3 cycles of pre-operative ECX chemotherapy.
16326448|NCT00450203|Drug|Lapatinib|1250mg/day Day 1-21 of each cycle of chemotherapy (6 cycles) plus day 1-21 of each maintenance course every 21 days for 6 doses.
16326449|NCT00450190|Device|Saizen® E-Device|Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
16326450|NCT00450177|Drug|Ferrous Sulfate|Iron group
16326451|NCT00450177|Drug|Placebo Oral Tablet|Placebo group
16326452|NCT00450164|Procedure|esofagic varices ligation|
16326453|NCT00450164|Drug|Nadolol|
16326454|NCT00450164|Drug|Isosorbide mononitrate|
16326455|NCT00450164|Drug|Prazosin|
16326456|NCT00450138|Drug|ZD6474 (vandetanib)|once daily oral dose
16326457|NCT00450138|Drug|Cisplatin|intravenous infusion
16326458|NCT00450138|Radiation|Radiation|radiation of head and neck
16326459|NCT00450125|Other|Six-Minute Walk Test|Six-Minute walk tests at least one hour after vigorous exertion (such as exercise stress test) and at least 20 minutes in between the first and second six-minute walk tests
16326460|NCT00450125|Other|Exercise stress test|Scheduled gold standard exercise test, i.e. stress test, cycle ergometry with incremental workloads or oxygen consumption exercise studies
16326461|NCT00450112|Device|Gel-200|Single Intra-articular Injection
16326462|NCT00450099|Drug|bupivacaine|0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL.
16326463|NCT00450086|Drug|Budesonide|9 mg per day
16326464|NCT00450086|Drug|Mesalazine|3 g per day
16326465|NCT00450086|Drug|Placebo|0 g per day
16326466|NCT00450073|Drug|ergocalciferol (vitamin D2)|50,000 IU weekly
16326467|NCT00450073|Device|Sperti Del Sol Lamp|5 times a week for 12 weeks
16327078|NCT00445510|Drug|GSK256066|
16326468|NCT00450073|Drug|Vitamin D3|50,000 IU weekly
16326469|NCT00450060|Device|lumbar puncture with Quincke-design needles|
16326470|NCT00450060|Device|lumbar puncture with Sprotte-design needles|
16326471|NCT00450047|Device|Speed-feedback therapy system with a bicycle ergometer|
16326472|NCT00450047|Device|Ergometer at conventional settings|
16326473|NCT00450034|Procedure|drug - oriented multifaceted intervention|oriented multifaceted intervention
16326474|NCT00450021|Drug|[(11)C] MePPEP|
16326475|NCT00450008|Drug|GM-CSF|fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
16326476|NCT00450008|Drug|thalidomide|Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.
16326477|NCT00450008|Drug|docetaxel|Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.
16326478|NCT00449995|Procedure|confocal laser microscopy|
16326479|NCT00449982|Drug|Polyphenon E Ointment 10%, Polyphenon E Ointment 15%|
16326480|NCT00449969|Device|Zoll AED pro|Arm one (Extended feedback) offers full feedback guidance during CPR
16326481|NCT00449969|Device|Zoll AED pro|In arm two (limited feedback) feedback is modified lacking several elements of feedback
16326482|NCT00449956|Drug|dorzolamide hydrochloride (+) timolol maleate|Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
16326483|NCT00449956|Drug|Comparator: timolol maleate|timolol maleate 0.5%, 8-week
16326484|NCT00449956|Drug|Comparator: dorzolamide hydrochloride|dorzolamide hydrochloride 1%, 8-week
16326485|NCT00449943|Procedure|Computed Tomographic Angiography|CT scan
16326486|NCT00449943|Procedure|Myocardial Perfusion Imaging Scan|SPECT
16326487|NCT00449930|Drug|sitagliptin phosphate|(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
16326488|NCT00449930|Drug|Comparator: metformin hydrochloride|(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.
16326489|NCT00449917|Drug|lutein|
16326490|NCT00449917|Drug|DHA|
16326491|NCT00449917|Drug|vitamins|
16326492|NCT00449904|Drug|Liprotamase|Administered orally
16326493|NCT00449878|Drug|Liprotamase|Administered orally
16326494|NCT00449878|Drug|Placebo|Administered orally
16326495|NCT00449865|Drug|creatine|"Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
~The study is comparing creatine 5 grams twice daily with placebo."
16326496|NCT00449865|Other|placebo|an inactive substance
16326497|NCT00449852|Behavioral|Interactive Voice Response|The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
16326498|NCT00449839|Drug|Insulin Aspart|"A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus.
~C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted."
16326499|NCT00449826|Procedure|Computed Tomographic Angiography|CT scan
16326500|NCT00449813|Drug|Pantoprazole|40 mg Pantoprazole
16326501|NCT00449800|Drug|ceftriaxone|
16326502|NCT00449787|Drug|Sumatriptan 100 mg|Sumatriptan 100mg tablet
16326503|NCT00449787|Drug|Naproxen|Naproxen 500mg tablet
16326504|NCT00449774|Drug|Lamotrigine IR tablets|Lamotrigine IR tablets will be available in dose strength of 200 mg.
16326505|NCT00449774|Drug|Lamotrigine ODT tablets|Lamotrigine ODT tablets will be available in dose strength of 200 mg.
16326506|NCT00449761|Drug|LBH589|
16326507|NCT00449748|Drug|RAD001 (Everolimus)|Oral RAD001 10 mg daily for 30 days
16326508|NCT00449722|Drug|mesalazine|
16326509|NCT00449709|Drug|GSK221149|
16326510|NCT00449696|Device|Gel-200|Single intra-articular injection
16326511|NCT00449696|Device|Placebo|Single intra-articular injection
16326512|NCT00449683|Drug|terazosin|off-label use of terazosin to treat antidepressant-induced sweating
16326513|NCT00449670|Biological|H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)|Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
16326514|NCT00449670|Biological|H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)|Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
16326515|NCT00449670|Biological|H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)|Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.
16326516|NCT00449657|Drug|Taxol (paclitaxel)|paclitaxel 15mg/m2 Q am on Mon/Wed/Fri
16326517|NCT00449657|Procedure|Radiotherapy|"Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before.
~Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5"
16326518|NCT00449657|Drug|Carboplatin|Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9
16326519|NCT00449657|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9
16326520|NCT00449644|Drug|TMC207|TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.
16326521|NCT00449644|Drug|Placebo|Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.
16326522|NCT00449644|Drug|Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)|Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.
16327010|NCT00445900|Other|laboratory biomarker analysis|
16326523|NCT00449618|Drug|Aspirin 100 mg|dose of 100 mg administered on awakening or at bedtime
16326524|NCT00449618|Device|Ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
16326525|NCT00449618|Procedure|Chronotherapy, timing of medication|Dosing on awakening versus bedtime
16326526|NCT00449618|Drug|Placebo|Use of placebo on awakening versus bedtime
16326527|NCT00449605|Drug|Rimonabant|Tablet, oral administration
16326528|NCT00449605|Drug|Glimepiride|Tablet, oral administration
16326529|NCT00449605|Drug|Metformin|Metformin continued at stable dose as background therapy
16326530|NCT00449592|Drug|Zinc|Oral Zincol 1 Tab TID from day -6/-7 until discharge
16326531|NCT00449592|Drug|Placebo|Oral placebo 1 Tab TID from day -6/-7 until discharge
16326532|NCT00449579|Device|Excercise stress test with high frequency ECG recording (HyperQ™ System)|
16326533|NCT00449553|Drug|Pioglitazone and sulphonylurea|Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
16326534|NCT00449553|Drug|Pioglitazone and sulphonylurea|Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
16326535|NCT00449553|Drug|Pioglitazone and metformin|Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
16326536|NCT00449553|Drug|Pioglitazone and metformin|Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
16326537|NCT00449540|Device|Active Transcranial Magnetic Stimulation (TMS) Device|Transcranial Magnetic Stimulation Device treatment
16326538|NCT00449540|Device|Sham TMS Device|Simulated Sham treatment without TMS delivery
16326539|NCT00449527|Drug|Budesonide/formoterol pMDI|
16326540|NCT00449527|Drug|Budesonide HFA pMDI|
16326541|NCT00449514|Drug|tamoxifen|
16326542|NCT00449514|Drug|clomiphene citrate|
16326543|NCT00449501|Drug|Budesonide/formoterol pMDI|
16326544|NCT00449501|Drug|Budesonide HFA pMDI|
16326545|NCT00449488|Drug|epoetin alfa|epoetin alfa 60.000 IU one i.v. bolus
16326546|NCT00449462|Procedure|consumption of CLA enriched food|
16326547|NCT00449449|Drug|Pertubation with Lidocain Solution|
16326548|NCT00449436|Drug|TRIZIVIR|TRIZIVIR
16326549|NCT00449436|Drug|Non-nucleoside reverse transcriptase inhibitor|Non-nucleoside reverse transcriptase inhibitor
16326550|NCT00449436|Drug|Boosted Protease Inhibitor|Boosted Protease Inhibitor
16326551|NCT00449423|Drug|acipimox|
16326552|NCT00449410|Drug|Atorvastatin|
16326553|NCT00449410|Drug|ezetimibe|
16326554|NCT00449397|Drug|Quetiapine Fumarate|
16326555|NCT00449384|Behavioral|Diagnostic Screening|
16326556|NCT00449358|Procedure|apply methyl-ALA cream|
16326557|NCT00449345|Procedure|Blood test for Quantiferon-GOLD assay|
16326558|NCT00449319|Procedure|Identification of appropriate therapies according to risks factors|
16326559|NCT00449319|Drug|Daunorubicine|
16326560|NCT00449319|Procedure|Transplant|
16326561|NCT00449293|Behavioral|standard cognitive behavioral therapy|Standard therapy to help participants with smoking cessation.
16326562|NCT00449293|Behavioral|Mindfulness Based Cognitive Therapy|A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
16326563|NCT00449280|Drug|Sorafenib|400mg BID (200 mg twice daily)
16326564|NCT00449280|Drug|Rapamycin|30mg once weekly
16326565|NCT00449280|Drug|Rapamycin|3mg once daily
16326566|NCT00449267|Device|Intraocular Lens|Phacoemulsification with in the bag implantation of the IOL
16326567|NCT00449254|Drug|oleoyl-estrone (MP-101)|
16326568|NCT00449241|Device|Acupuncture|
16326569|NCT00449228|Procedure|-preoperative education and total hip replacement|-preoperative education and total hip replacement
16326570|NCT00449202|Drug|oleoyl-estrone (MP 101)|
16326571|NCT00449176|Drug|tapentadol (CG5503) ER|50, 100, 150, 200, 250 mg twice daily for 15 weeks
16326572|NCT00449176|Drug|oxycodone CR|10, 20, 30, 40, 50 mg twice daily for 15 weeks
16326573|NCT00449176|Drug|placebo|matching placebo twice daily for 15 weeks
16326574|NCT00449163|Biological|Bevacizumab|
16326575|NCT00449163|Drug|Floxuridine|
16326576|NCT00449163|Drug|Irinotecan|
16326577|NCT00449163|Drug|Leucovorin|
16326578|NCT00449150|Drug|Cetrorelix 78 mg + 78 mg|
16326579|NCT00449150|Drug|Cetrorelix 78 mg + 52 mg|
16326580|NCT00449150|Drug|Placebo|
16326581|NCT00449137|Drug|Arsenic trioxide|ATO will be administered at dose levels determined by the dose escalation scheme (section 4.2). Intra-venous (IV) infusion of ATO (mg/kg body weight) over 1-4 hours will be administered for 5 consecutive days (day 1 to day 5) during the first week, twice a week on weeks 2 and 3 (days 8, 11, 15, and 18), and only one day (day 22) of week 4. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
16326582|NCT00449137|Drug|Fluorouracil|Escalate 5-FU, starting at dose 1600 mg/m2. On day 8, 15, and 22 the assigned dose of 5 FU plus 500 mg/m2 of leucovorin will be administered over 24 hours intravenous infusion following the administration of arsenic trioxide. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
16326583|NCT00449137|Drug|Leucovorin calcium|On day 8, 15, and 22 the assigned dose of 5 FU plus 500 mg/m2 of leucovorin will be administered over 24 hours intravenous infusion following the administration of arsenic trioxide. Treatment will continue for a maximum of 8 cycles, provided that the patient tolerates treatment and there is evidence of clinical benefit.
16326584|NCT00449137|Other|Plasma levels of elemental arsenic|Pre-Treatment and and one hour post ATO on days 1, 5, 8, 11,15, 18, and 22
16326585|NCT00449137|Genetic|Peripheral Blood Mononuclear Cells (PBMC) for mRNA analysis|Peripheral blood samples (PAXgene Blood RNA tube, Qiagen, USA) will be obtained up to 2 weeks prior to start of treatment (same day as the first FNA) and one hour post ATO on days 1, 5, 8, 11,15, 18, and 22. Along with FNA an additional blood sample will be obtained on day 23 of every odd treatment cycle.
16326586|NCT00449137|Procedure|Tumor Biopsy (Fine-Needle Aspiration)|Pre-Treatment, Day 23 of Cycles 1, 3, 5, 7
16326587|NCT00449124|Drug|Placebo|Injections of 0.5 mL of normal saline solution (0.9% NaCl).
16326588|NCT00449124|Biological|TG4040|Modified vaccinia virus Ankara encoding hepatitis C virus (HCV) proteins NS3, NS4, and NS5B administered by subcutaneous injection into the thigh. Dosages: TG4040 10^6 PFU, TG4040 10^7 PFU and TG4040 10^8 PFU.
16326589|NCT00449111|Drug|MK0954, losartan potassium / Duration of Treatment - 12 weeks|
16326590|NCT00449098|Device|OculusGen Biodegradable Collagen Matrix Implant|Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
16326591|NCT00449098|Drug|Trabeculectomy with MMC|Trabeculectomy with MMC
16326592|NCT00449085|Procedure|Electrophysiology|
16326593|NCT00449085|Device|CARTO™ XP EP Navigation System V9|
16326594|NCT00449072|Other|Placebo|Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration
16326595|NCT00449072|Other|Placebo|Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period
16326596|NCT00449072|Drug|TAA-AQ, Nasacort® AQ|110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period
16326597|NCT00449072|Drug|Claritin®|Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label
16326598|NCT00449059|Drug|acute infusion of nitroglycerine into the pulmonary artery|
16326599|NCT00449046|Drug|GW815SF Salmeterol/Fluticasone propionate(HFA MDI)|
16326600|NCT00449033|Drug|Sorafenib (Nexavar, BAY43-9006)|Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV
16326601|NCT00449033|Drug|Placebo|Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m^2 IV, Cisplatin 75 mg/m^2 IV
16326602|NCT00449033|Drug|Gemcitabine|Chemotherapy component; Gemcitabine 1250 mg/m^2 IV
16326603|NCT00449033|Drug|Cisplatin|Chemotherapy component; Cisplatin 75 mg/m^2 IV
16326604|NCT00449020|Drug|Carboplatin|CARBOPLATIN (AUC=2) IV in 250 cc NS over 30 minutes, weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
16326605|NCT00449020|Drug|Docetaxel|DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.
16326606|NCT00449020|Drug|irinotecan hydrochloride|IRINOTECAN 30 mg/m2 IV over 90 minutes weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
16326607|NCT00449020|Radiation|radiation therapy|Radiotherapy will start on the first day of scheduled chemotherapy. The daily administered dose will be 1.8 Gy, 5 days a week for 4.4 weeks, 22 fractions, ( 39.6 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV). After 39.6 Gy, the same targets will be treated by oblique fields at 1.8 GY for 3 fxs to a toal dose of 45 GY. Thereafter, the primary tumor and involved nodal metastasis (secondary planning target volume SPTV) will be boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose will be 63 Gy in 35 fractions over seven weeks.
16326608|NCT00449007|Drug|fluoxetine|6 months
16326609|NCT00449007|Drug|bupropion|6 months
16326610|NCT00448981|Behavioral|Hand hygiene and educational material|
16326611|NCT00448981|Device|Mask, alcohol and hand sanitizer|
16326612|NCT00448955|Drug|ARD-0403|ARD-0403
16326613|NCT00448942|Behavioral|Daily bathing with Chlorhexidine based product|
16326614|NCT00448929|Device|OculusGen Biodegradable Collagen Matrix Implant|Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
16326615|NCT00448916|Drug|Pregabalin|Orally-administered pregabalin
16326616|NCT00448903|Drug|Bemiparin|Bemiparin sodium
16326617|NCT00448903|Drug|Placebo|Sodium Chloride 0,9%
16326618|NCT00448890|Drug|GSK729327|Tablets
16326619|NCT00448890|Drug|Placebo|GSK729327 Matching placebo - Tablets
16326620|NCT00448877|Device|fNIR light emitting and sensing device|
16326621|NCT00448864|Drug|Ecallantide|
16326622|NCT00448864|Drug|Placebo|
16326623|NCT00448851|Biological|inhaled allergen challenge|Subjects will inhale gradually increasing concentrations of Dermatophagoides farinae until a 15% drop in FEV1 is noted
16326624|NCT00448838|Biological|Cetuximab|Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.
16326625|NCT00448838|Drug|Gemcitabine Hydrochloride|Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.
16326626|NCT00448838|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.
16326627|NCT00448825|Drug|Topiramate + Cognitive Behavioral Therapy|Topiramate up to 300 mg per day
16326628|NCT00448825|Drug|Placebo + Cognitive Behavioral Therapy|Placebo twice a day
16326629|NCT00448812|Device|Bronchial Thermoplasty with the Alair System|Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).
16326630|NCT00448799|Radiation|[123-I] AV-83 Injection and Imaging Procedures|Evaluation of [123I] AV83 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
16326631|NCT00448786|Drug|AMG 706|Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
16326632|NCT00448786|Drug|AMG 706|Arm C - 75 mg BID 5-days on, 2-days off
16326633|NCT00448786|Drug|AMG 706|AMG 706 125 mg daily continuously (Arm A)
16326634|NCT00448773|Behavioral|Online education|
16326635|NCT00448760|Drug|Docetaxel|Intravenously, 25 mg/m2, over 30 minutes, 2 cycles
16326636|NCT00448760|Drug|Floxuridine|Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles
16326637|NCT00448760|Drug|Leucovorin|Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles
16326638|NCT00448760|Drug|Oxaliplatin|Intravenously, 85 mg/m2, over 2 hours, 2 cycles
16326639|NCT00448760|Genetic|Microarray analysis|Analysis of tumor for pathologic response to protocol therapy
16326640|NCT00448760|Genetic|reverse transcriptase-polymerase chain reaction|Analysis of tumor for pathologic response to protocol therapy
16326641|NCT00448760|Procedure|Conventional surgery|Surgical removal of tumor for correlative studies
16326642|NCT00448747|Drug|AEZS-130 (formerly ARD-07)|A single oral administration of AEZS-130 as Growth Hormone Stimulation Test
16326643|NCT00448747|Drug|L-ARG+GHRH|A single administration of L-ARG+GHRH (iv bolus) followed by a 30min infusion of L-ARG as Growth Hormone Stimulation Test
16326644|NCT00448734|Drug|Picoplatin|"The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
~Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion."
16326645|NCT00448734|Drug|docetaxel|"The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
~Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion."
16326646|NCT00448721|Drug|Perifosine|Perifosine will be administered orally at 100mg PO daily with food.
16326647|NCT00448708|Device|Vascular Wrap Paclitaxel-Eluting Mesh|0.9 µg/mm^2 paclitaxel
16326648|NCT00448708|Device|Lifespan® ePTFE Vascular Graft|vascular graft
16326649|NCT00448708|Device|Lifespan® ePTFE Vascular Graft|vascular graft
16326650|NCT00448695|Procedure|MRI Targeted Focal Thermal Therapy of Prostate Cancer|The Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure.
16326651|NCT00448682|Drug|Docetaxel|
16326652|NCT00448682|Drug|Floxuridine|
16326653|NCT00448682|Drug|Leucovorin|
16326654|NCT00448682|Drug|Oxaliplatin|
16326655|NCT00448669|Drug|Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg|
16326656|NCT00448669|Drug|Placebo Oral Tablet|
16326657|NCT00448656|Procedure|ablation of pulmonary veins by video assisted thoracic surgery|epicardial ablation using HIFU
16326658|NCT00448643|Radiation|Vaginal Brachytherapy|High-Dose Rate [HDR] or Low-Dose Rate [LDR], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy
16326659|NCT00448643|Drug|Cisplatin|Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy
16326660|NCT00448643|Radiation|Whole Abdominal Radiation [WAR] Therapy|Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
16326661|NCT00448630|Other|No intervention|Non-interventional study
16326662|NCT00448591|Drug|bevacizumab [Avastin]|10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
16326663|NCT00448591|Drug|Taxane-based chemotherapy|As prescribed
16326664|NCT00448578|Drug|Quetiapine Fumarate|
16326665|NCT00448578|Drug|Lithium|
16326666|NCT00448552|Drug|capecitabine|
16326667|NCT00448552|Drug|oxaliplatin|
16326668|NCT00448539|Drug|Rufinamide|Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
16326669|NCT00448526|Behavioral|low protein diet|
16326670|NCT00448513|Dietary Supplement|catechin extracts|comparison with placebo
16326671|NCT00448474|Behavioral|Mailed Arthritis Self-Management Education|
16326672|NCT00448461|Drug|heparin|comparison between heparin and bivalirudin
16326673|NCT00448461|Drug|bivalirudin|comparison between heparin and bivalirudin
16326674|NCT00448448|Device|Brace|Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.
16326675|NCT00448448|Other|Observation|Clinical, radiographic, and self-report follow-up every 6 months.
16326676|NCT00448435|Drug|GW815SF HFA MDI|salmeterol and fluticasone propionate combination
16326677|NCT00448435|Drug|salmeterol and fluticasone propionate|salmeterol + fluticasone propionate
16326678|NCT00448422|Drug|prulifloxacin|Tablet
16326679|NCT00448409|Biological|TroVax|11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.
16326680|NCT00448409|Drug|GM-CSF|168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).
16326681|NCT00448396|Drug|Patupilone|
16326682|NCT00448383|Biological|adalimumab|40mg every other week
16326683|NCT00448357|Biological|rabbit anti-thymocyte globulin (ATG)|.5 mg/kg on day -3 and 2.5 mg/kg on day -2
16326684|NCT00448357|Biological|therapeutic allogeneic lymphocytes|minimum total cluster of differentiation (CD34+) cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on day 0
16326685|NCT00448357|Drug|busulfan|PK-targeted continuous IV infusion over 90 hours on Days -7 to -4.
16326686|NCT00448357|Drug|fludarabine phosphate|30 mg/m^2/day x 5 days intravenous piggyback (IVPB) over 30 minutes on Days -7 through -3
16326687|NCT00448357|Drug|tacrolimus|The suggested starting dose is 0.03 mg/kg po bid starting on day -1
16326688|NCT00448357|Procedure|allogeneic hematopoietic stem cell transplantation|A minimum total CD34+ cell dose of 3 x 10^6 cells/kg and maximum of 8 x 10^6 cells/kg will be infused on day 0
16326689|NCT00448357|Procedure|peripheral blood stem cell transplantation|minimum total CD34+ cell dose of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on day 0
16326690|NCT00448357|Drug|methotrexate|5 mg/m^2 on days +1, +3 and +6
16326691|NCT00448344|Behavioral|Family-supported|Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking
16326692|NCT00448344|Behavioral|Standard Telephone counseling|Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
16326693|NCT00448318|Procedure|Music Therapy|
16326694|NCT00448305|Drug|EndoTAG-1 + paclitaxel|EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
16326695|NCT00448305|Drug|EndoTAG-1|EndoTAG-1 44 mg/m² twice weekly
16326696|NCT00448305|Drug|Paclitaxel|Paclitaxel 90 mg/m² weekly
16326697|NCT00448292|Drug|PRX-00023|Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
16326698|NCT00448292|Drug|Placebo for PRX-00023|Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
16326699|NCT00448279|Drug|trastuzumab|2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
16326700|NCT00448279|Drug|Chemotherapy|Schedule and dose at the investigator's discretion
16326701|NCT00448266|Drug|Intensified Cyclophophamide, Carboplatin and Thiotepa|2 courses of Intensified Cyclophophamide, Carboplatin and Thiotepa with PBPC support
16326702|NCT00448266|Drug|dose dense adriamycine and cyclophosphamide|dose dense adriamycine and cyclophosphamide, Q 2 weeks
16326703|NCT00448253|Biological|NP-015|"Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo.
~And a Fourth Cohort at 840 units TNA with 2 additional product lots."
16326704|NCT00448240|Drug|Erlotinib|loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
16326705|NCT00448227|Drug|famciclovir|Administered orally as a single individualized dose between 25-200 mg based on body weight.
16326706|NCT00448214|Drug|YM150|Oral
16326707|NCT00448214|Drug|warfarin|Oral
16326708|NCT00448201|Biological|anti-thymocyte globulin|0.5 mg/kg on day -3, 2.5 mg/kg on day -2 (groups 2, 3 and 4) and 3 mg/kg on day -1 (group 4 only)
16326709|NCT00448201|Biological|sargramostim|GM-CSF 500 ug everyday (QD) subcutaneously will be given to recipients who remain with an Absolute neutrophil count (ANC) < 1000/microliter (uL) past day 20
16326710|NCT00448201|Biological|therapeutic allogeneic lymphocytes|A minimum total cluster of differentiation 34 (CD34)+ cell dose of 3 x 10^6 cells/kg and a maximum 8 x 10^6 cells/kg will be infused on day 0
16326711|NCT00448201|Drug|busulfan|6.4 mg/kg by continuous IV infusion over 48 hours on Days -6 and -5
16326712|NCT00448201|Drug|fludarabine phosphate|fludarabine 30 mg/m^2/day x 5 days IV piggyback (IVPB) over 30 minutes on Days -7 through -3
16326713|NCT00448201|Drug|methotrexate|Methotrexate 5 mg/m^2 per day on days +1, +3 and +6
16326714|NCT00448201|Drug|tacrolimus|Suggested starting dose is 0.03 mg/kg po bid starting on Day -1
16326715|NCT00448201|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Minimum total CD34+ cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on Day 0
16326716|NCT00448201|Procedure|peripheral blood stem cell transplantation|Minimum total CD34+ cells of 3 x 10^6 cells/kg and a maximum of 8 x 10^6 cells/kg will be infused on Day 0
16326717|NCT00448188|Procedure|central venous catheter application|
16326718|NCT00448175|Device|Urgent PC Neuromodulation System|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
16326719|NCT00448175|Drug|Tolterodine|
16326720|NCT00448149|Drug|RAD001|RAD001 will be administered orally once a day, daily, without interruption per 4 wk cycle for 2 cycles. MTD is established in Phase I portion of trial (2.5, 5 or 10mg). If responding, additional therapy will be given.
16326721|NCT00448149|Drug|Sorafenib|A dose of 400mg of Nexavar® will be administered orally twice a day, daily, without an interruption per 4 week cycle for 2 cycles. If responding, additional therapy will be given.
16326722|NCT00448136|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 every 3 weeks
16326723|NCT00448136|Drug|5 FU|400mg/m2/day iv on days 1-5 every 6 weeks
16326724|NCT00448136|Drug|Streptozotocin|500mg/m2/day iv on days 1-5 every 6 weeks
16326725|NCT00448136|Drug|Xeloda|1000mg/m2 po bid on days 1-14 every 3 weeks
16326726|NCT00448123|Drug|Tamsulosin|Study Drug
16326727|NCT00448123|Drug|Placebo|Placebo
16326728|NCT00448110|Drug|Intravenous Diclofenac (DIC075V)|Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
16326729|NCT00448110|Drug|Intravenous Ketorolac|Intravenous Ketorolac
16326730|NCT00448110|Drug|placebo|placebo
16326731|NCT00448097|Drug|cetuximab|No verifiable data available, PI relocated
16326732|NCT00448097|Drug|docetaxel|No verifiable data available, PI relocated
16326733|NCT00448071|Drug|MTR107|
16326734|NCT00448058|Drug|GSK372475|daily administration during the 10-week treatment phase
16326735|NCT00448058|Drug|venlafaxine|daily administration during the 10-week treatment phase
16326736|NCT00448058|Drug|placebo|daily administration during the 10-week treatment phase
16326737|NCT00448045|Behavioral|Manual and mechanical assisted cough|Individuals will be given a pulse oximeter and taught both manually assisted and mechanically assisted coughing techniques to maximize their cough. Manually assisted coughing consists of air stacking to deep insufflations. An abdominal thrust is then applied upon glottic opening to augment the cough. These subjects will also have rapid access to a mechanical in-exsufflator (CoughAssistTM) and will be trained on how to access and use this device. Mechanically assisted coughing (MAC) involves the use of the CoughAssistTM to expand the lungs and then quickly reverse the pressure to rapidly empty the lungs with expiratory (cough) flows of 600 L/m. An abdominal (manual) thrust is applied in conjunction with the negative pressure (exsufflation) to further increase cough.
16326738|NCT00448045|Behavioral|Incentive spirometry|These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
16326739|NCT00448032|Drug|PPM-204|
16326740|NCT00448019|Drug|Fludarabine|25 mg/m^2 IV over 30 minutes daily for 3 days
16326741|NCT00448019|Drug|Cyclophosphamide|250 mg/m^2 IV over 30 minutes daily for 3 days
16326742|NCT00448019|Drug|Rituximab|375 mg/m^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m^2 IV 30-minute infusion.
16326743|NCT00448019|Drug|Bevacizumab|10 mg/Kg IV on Day 3, course 1 over 30-90 minutes
16326744|NCT00448006|Device|Allium Biliary Stent|device
16326745|NCT00448006|Device|allium biliary stent|allium biliary stent
16326746|NCT00447993|Drug|NT-501|High Dose
16326747|NCT00447993|Drug|NT-501|Low Dose
16326748|NCT00447980|Drug|NT-501|High Dose
16326750|NCT00447967|Drug|Irinotecan|Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
16326751|NCT00447967|Drug|Oxaliplatin|Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
16326752|NCT00447967|Drug|Fluorouracil|Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
16326753|NCT00447967|Drug|Leucovorin|Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
16326754|NCT00447967|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
16326755|NCT00447954|Drug|NT-501 implant|High Dose
16326756|NCT00447954|Drug|NT-501 implant|Low Dose
16326757|NCT00447954|Other|Sham Procedure|Sham Procedure
16326758|NCT00447941|Drug|SCA-136|
16326759|NCT00447928|Drug|OrthoDerm transdermal nitroglycerin patch|
16326760|NCT00447915|Drug|ibandronic acid 0.5mg|0.5mg(i.v.)/month for 35 months
16326761|NCT00447915|Drug|RIS placebo|0 mg(p.o.)/day for 36 months
16326762|NCT00447915|Drug|1.0mg ibandronic acid|1.0mg(i.v.)/month for 35 months
16326763|NCT00447915|Drug|ibandronic acid placebo|0mg(i.v.)/month for 35 months
16326764|NCT00447915|Drug|2.5mg RIS|2.5 mg(p.o.)/day for 36 months
16326765|NCT00447915|Dietary Supplement|Calcium and Vitamine D3|Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
16326766|NCT00447902|Drug|tipranavir|
16326767|NCT00447902|Drug|ritonavir|
16326768|NCT00447889|Drug|gadoteric acid|
16326769|NCT00447876|Biological|Botulinum toxin type A|Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
16326770|NCT00447876|Drug|Placebo|0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
16326771|NCT00447863|Drug|Levonorgestrel/Ethinyl Estradiol|
16326772|NCT00447850|Procedure|endometrial biopsy|
16326773|NCT00447837|Drug|SPRC-AB01|90 mg/3 mL BID, 180 mg/3 mL bid, placebo
16326774|NCT00447824|Procedure|Introduction of better conditions during blood sampling|
16326775|NCT00447811|Drug|MOA-728|
16326776|NCT00447798|Behavioral|Prevention Care Advocate|Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management
16326777|NCT00447772|Biological|Botulinum toxin type A|Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
16326778|NCT00447759|Drug|Celecoxib|200-400mg daily in divided doses
16326779|NCT00447759|Drug|Diclofenac|prescribed medication taken orally
16326780|NCT00447746|Procedure|D1 or D2 lymphadenectomy for gastric cancer patients|
16326781|NCT00447733|Behavioral|Integrated mental health and substance use treatment|Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
16326782|NCT00447733|Behavioral|Treatment as usual|Non-standardized psychiatric outpatient treatment
16326783|NCT00447720|Behavioral|PATH|We have chosen to translate two proven prevention programs for delivery to the SMI populations by their case managers. These interventions are the Brief Counseling intervention from the Project Respect program and the Community-Based Outreach Program (CBOM). Together we will translate them into ongoing case management for SMI persons who also abuse substances in the Preventing AIDS through Health Project (PATH). Consistent with other findings regarding HIV infections among the SMI, in our preliminary studies we found that these individuals are at much higher risk within the population of persons being served in Philadelphia.
16326784|NCT00447707|Behavioral|Positive Choice|
16326785|NCT00447694|Drug|Deferasirox|Oral deferasirox 30mg/kg/day once per day for 77 weeks.
16326786|NCT00447681|Drug|ILV-094|
16326787|NCT00447668|Behavioral|Yoga|Yoga for back pain
16326788|NCT00447668|Behavioral|Exercise|exercises for back pain
16326789|NCT00447668|Behavioral|Self-care book recommendations|Self-care book for back pain
16326790|NCT00447655|Behavioral|Self-management and peer support|
16326791|NCT00447642|Drug|LX201|"LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
~LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded."
16326792|NCT00447642|Other|Placebo|The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
16326793|NCT00447629|Drug|PPM-204|
16326794|NCT00447603|Drug|hydrochlorothiazide (+) losartan potassium|losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
16326795|NCT00447603|Drug|losartan potassium|Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
16326796|NCT00447603|Drug|Placebo for Losartan|
16326797|NCT00447603|Drug|Placebo for Losartan/HCTZ|losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
16326798|NCT00447590|Device|LAP-BAND System|Restriction of food intake
16326799|NCT00447577|Drug|Loteprednol etabonate and tobramycin ophthalmic suspension|Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
16326800|NCT00447577|Drug|Tobramycin and dexamethasone ophthalmic suspension|Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
16326801|NCT00447564|Drug|Probuphine|4 implants
16326802|NCT00447564|Drug|placebo|4 implants
16326803|NCT00447551|Drug|Poly-L-Lactic Acid|Deep dermal injection
16326804|NCT00447525|Biological|REVAXIS®|
16326805|NCT00447525|Biological|DT-Polio®|
16326806|NCT00447512|Drug|ghrelin|acylated ghrelin
16326807|NCT00447499|Drug|Somatuline Autogel (lanreotide acetate)|Injections
16326808|NCT00447499|Behavioral|Home administration|Questionnaire
16326809|NCT00447486|Drug|GW842166|
16326810|NCT00447473|Drug|GM-CSF|GM-CSF will be administered as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) on weeks 2 and 3 each 21 day cycle (total of 14 days).
16326811|NCT00447473|Drug|Ketoconazole|Ketoconazole will be administered daily at a dose of 400 mg po tid (either 1 hour before or 2 hours after meals), ascorbic acid 250 mg po tid (given with ketoconazole) and replacement doses of hydrocortisone (20 mg po in the morning and 10 mg po in the evening).
16326812|NCT00447473|Drug|Mitoxantrone|Mitoxantrone will be given at dose of 12 mg/m2 every 3 weeks, up to a maximum cumulative dose of 140 mg/m2
16326813|NCT00447460|Procedure|Mesenchymal stem cell (MSC)|
16326814|NCT00447434|Drug|Natto extract (Nattokinase)|
16326815|NCT00447421|Drug|pemetrexed|"Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
~Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles"
16326816|NCT00447421|Drug|cisplatin|Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
16326817|NCT00447421|Radiation|radiation|Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4
16326818|NCT00447408|Behavioral|Standard hemodialysis dietary instruction|Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
16326819|NCT00447408|Behavioral|Behavioral counseling plus PDA-based self-monitoring of diet|Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.
16326820|NCT00447382|Drug|insulin detemir|NN304 injected s.c. (under the skin). Given as basal insulin.
16326821|NCT00447382|Drug|insulin aspart|Injected s.c. (under the skin). Given as bolus insulin.
16326822|NCT00447382|Drug|insulin detemir|NN729 injected s.c. (under the skin). Given as basal insulin
16326823|NCT00447369|Drug|Pregabalin|
16326824|NCT00447369|Drug|sodium valproate|
16326825|NCT00447356|Drug|recombinant interferon alfa|
16326826|NCT00447343|Procedure|Decompressive cervical spine surgery|"Treatment group (25 patients) will undergo decompressive anterior cervical spine surgery
~Healthy volunteers will ONLY undergo two scans 6 months apart."
16326827|NCT00447343|Procedure|fMRI and MRS scan|A scan pre-op and 6 months post-op.
16326828|NCT00447330|Drug|capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin)|"Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.
~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.
~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
16326829|NCT00447317|Behavioral|BalanceWise-PD|Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
16326830|NCT00447317|Behavioral|Attention control|Standard peritoneal dialysis dietary education
16326831|NCT00447304|Drug|moxifloxacin|
16326832|NCT00447304|Procedure|cholecystectomy|
16326833|NCT00447291|Drug|Supplement: Omega-3 Fish Oil|
16326834|NCT00447291|Behavioral|Multi-Disciplinary Nutrition & Exercise program|
16326835|NCT00447278|Drug|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
16326836|NCT00447278|Drug|Other standard therapy for ADHD|Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
16326837|NCT00447265|Drug|Etanercept|1.) Immune suppressant. 2.) Tumor necrosis factor (TNF) inhibitor.
16326838|NCT00447265|Drug|Lupus Treatment- Standard of Care|Individualized standard of care treatment for lupus with corticosteroids and with mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA)
16326839|NCT00447265|Drug|Placebo|
16326840|NCT00447239|Procedure|glucontrol (insulin therapy)|
16326841|NCT00447226|Drug|Oral lapatinib tablets or placebo tablets|Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.
16326842|NCT00447213|Drug|Insulin glargine|Patient specific, injected, daily, 24 weeks
16326843|NCT00447213|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals,12 weeks
16326844|NCT00447213|Drug|Injectable Insulin|Patient specific dose,injected, before meals, 12 weeks
16326845|NCT00447200|Procedure|Esophagus Doppler monitoring|
16326846|NCT00447200|Procedure|Fluid optimization|
16326847|NCT00447187|Drug|LX201|"LX201 is a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
~LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant was 0.08 inch wide and 0.04 inch in height. The implants were flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded."
16326848|NCT00447187|Other|Placebo|The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
16326849|NCT00447174|Behavioral|Dyadic treatment for parental bereavement|
16326850|NCT00447161|Drug|Bacillus Clausii Multi ATB Resist|Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
16326851|NCT00447161|Drug|Placebo|Matched placebo
16326852|NCT00447148|Procedure|3-dimensional coronary angiography|3-dimensional coronary angiography
16326853|NCT00447122|Drug|gemcitabine and Lapatinib|
16326854|NCT00447109|Device|Closed system suction|
16326855|NCT00447096|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Repetitive transcranial magnetic stimulation (rTMS).
16326856|NCT00447083|Device|UVB|UVB exposure by a tanning bed
16326857|NCT00447083|Procedure|Non-UVB|Non-UVB exposure by a tanning bed
16326858|NCT00447070|Drug|ATAZANAVIR|
16326859|NCT00447057|Drug|Pemetrexed|500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity
16326860|NCT00447057|Drug|Erlotinib|150 mg given orally (po), daily (QD), starting on the first day of the first cycle
16326861|NCT00447057|Drug|Pemetrexed|500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
16327011|NCT00445900|Procedure|biopsy|
16326862|NCT00447057|Drug|Erlotinib|150 mg given po, QD, starting on the first day of the first cycle
16326863|NCT00447044|Behavioral|Resistance Exercise|Subjects will lift weights with their legs.
16326864|NCT00447044|Dietary Supplement|diet orange soda|Subjects drink diet orange soda 3x day for 2 days.
16326865|NCT00447044|Dietary Supplement|essential amino acids|Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.
16326866|NCT00447031|Drug|intravitreal bevacizumab and triamcinolone acetonide|
16326867|NCT00447018|Drug|20% mannitol|
16326868|NCT00447018|Drug|7.45% hypertonic saline solution|
16326869|NCT00447005|Drug|Axitinib (AG-013736)|AG-013736 5mg twice daily [BID]
16326870|NCT00446992|Drug|Olanzapine|16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
16326871|NCT00446979|Drug|Placebo gel|HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
16326872|NCT00446979|Drug|UC 781|UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
16326873|NCT00446966|Drug|Omega Three Polyunsaturated fatty acids|2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.
16326874|NCT00446953|Drug|betamethasone|2x12 mg betamethazone c-section at 38 weeks
16326875|NCT00446953|Other|placebo|c-section at 39 weeks
16326876|NCT00446940|Drug|rosuvastatin|
16326877|NCT00446940|Drug|atorvastatin|
16326878|NCT00446914|Behavioral|Systems Change (High Blood Pressure Strategy)|
16326879|NCT00446901|Dietary Supplement|Selenium|Selenized yeast, 300 ug/day
16326880|NCT00446888|Behavioral|Standardized Meals for Diet Stabilization|Subjects will eat prepared meals for 3 days prior to their study; or they will document their dietary intake over this period.
16326881|NCT00446888|Dietary Supplement|Forticare|400 ml of commercially-available nutritional supplement.
16326882|NCT00446888|Dietary Supplement|Product 4808|400 ml Forticare, to which has been added extra protein and the amino acid leucine.
16326883|NCT00446875|Other|Administration of oral Sucrose|Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
16326884|NCT00446875|Other|Administration of oral Placebo|Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
16326885|NCT00446862|Drug|enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers|10 mg by mouth every day; 25 mg by mouth every day
16326886|NCT00446849|Drug|MMX Mesalamine|MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).
16326887|NCT00446836|Drug|Paclitaxel polyglumex (Xyotax)|biologically enhanced chemotherapeutic
16326888|NCT00446823|Device|XCell cellulose wound dressing|
16326889|NCT00446823|Device|Impregnated gauze dressing|
16326890|NCT00446810|Drug|Benfotiamine|
16326891|NCT00446810|Drug|Placebo|
16326892|NCT00446797|Drug|Non-selective NSAIDS|Non-selective NSAIDs administered at usual (standard) doses.
16326893|NCT00446797|Drug|Celecoxib|celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
16326894|NCT00446784|Drug|CE-224,535|
16326895|NCT00446784|Drug|Methotrexate|
16326896|NCT00446771|Drug|Mannitol|
16326897|NCT00446758|Dietary Supplement|Zinc|zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
16326898|NCT00446732|Device|UroSshield|Attachment of the UroShield device to the external part of the urinary catheter
16326899|NCT00446719|Drug|Rellidep|2000 mg P.O. daily for 8 weeks
16326900|NCT00446693|Device|EndoFast Reliant™ system for Pelvic Organ Prolapse repair|The EndoFast Reliant™ system is a new concept of reinforcing the vaginal wall with proprietary mesh and soft-tissue Fasteners in a minimally-invasive procedure.
16326901|NCT00446680|Drug|Mannitol|400mg BD for 6 months followed by a 6 month open label period
16326902|NCT00446680|Drug|placebo|placebo BD for 6 months
16326903|NCT00446667|Drug|mannitol|400mg BD for 2 days
16326904|NCT00446654|Drug|CGC-11047|16.5 mg (3.3%) subconjunctival injection
16326905|NCT00446641|Drug|Cilostazol|cilostazol 100mg twice a day for 4 weeks
16326906|NCT00446641|Drug|placebo|placebo 1 tablet twice a day matching for cilostazol
16326907|NCT00446628|Behavioral|behaviors reducing spread of influenza|Non-pharmaceutical interventions for flu prevention
16326908|NCT00446615|Behavioral|computer decision support tool|
16326909|NCT00446615|Behavioral|audit and feedback|
16326910|NCT00446615|Behavioral|group learning session|
16326911|NCT00446602|Drug|Epoetin alfa|Type=exact, unit=units, number=80,000, form=solution for injection, route=subcutaneous use, once every week or once every 2 weeks.
16326912|NCT00446589|Drug|ibandronate|iv 1mg ibandronate monthly for one year
16326913|NCT00446589|Drug|teriparatide|sc injection using a pen like device during every hemodialysis session (thrice a week)
16326914|NCT00446576|Drug|Epoetin Alfa|
16326915|NCT00446563|Drug|Valsartan|160 mg film coated tablets taken orally once daily in the morning.
16326916|NCT00446563|Drug|Amlodipine|5 mg or 10 mg tablets taken orally once daily in the morning.
16326917|NCT00446563|Drug|Hydrochlorothiazide|12.5 mg or 25 mg tablets taken orally once daily in the morning.
16326918|NCT00446563|Drug|Losartan|100 mg tablets taken orally once daily in the morning.
16326919|NCT00446550|Drug|afegostat tartrate|
16326920|NCT00446537|Procedure|Methylphenidate|
16326921|NCT00446524|Drug|Valsartan + Amlodipine besilate|During the run-in period, either Valsartan 80 mg or Amlodipine 5 mg tablet was given once daily. Throughout the Valsartan + Amlodipine treatment period, a Valsartan + Amlodipine tablet 80/5 mg was given once daily at around 8:00 AM in the morning.
16326922|NCT00446511|Drug|Valsartan|Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
16326923|NCT00446511|Drug|Enalapril|Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
16326924|NCT00446511|Drug|placebo matched to enalapril|Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
16326925|NCT00446511|Drug|placebo matched to valsartan|placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
16326926|NCT00446498|Device|CPAP and Non Invasive Ventilation|
16326927|NCT00446485|Drug|Ginkgo biloba standardized extract 24/6|tablets, 120 mg/day (60 mg two times daily) during 6 months
16326928|NCT00446485|Drug|Ginkgo Biloba standardized extract 24/6|tablets, 60 mg/day during 6 months
16326929|NCT00446485|Drug|placebo|placebo during 6 months
16326930|NCT00446472|Drug|Regranex®|Regranex gel will be used for a total of 16 weeks
16326931|NCT00446472|Drug|Hydrogel|Placebo hydrogel will be applied for 16 weeks
16326932|NCT00446459|Drug|mycophenolate mofetil (CellCept)|500mg - 1,000mg, taken PO, twice daily.
16326933|NCT00446446|Drug|Panitumumab|Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.
16326934|NCT00446433|Drug|CC-5013|
16326935|NCT00446420|Drug|Propofol, midazolam, fentanyl|All drugs administered in doses according to anaesthetists' discretion during sedation for colonoscopy
16326936|NCT00446407|Other|Collaborative Stepped Care Intervention|Psychoeducation, interpersonal therapy, fluoxetine (20-40 mg/d), adherence management
16326937|NCT00446407|Other|Enhanced Usual Care|Screening plus Antidepressants based on practice guidelines
16326938|NCT00446394|Behavioral|Resources and Activities for Life Long Independence (RALLI)|Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks
16326939|NCT00446394|Behavioral|Social Walking program (SW)|Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
16326940|NCT00446381|Drug|Macugen (pegaptanib)|Pegaptanib 0.3 mg by intravitreal injection once pre-operatively
16326941|NCT00446381|Drug|Macugen (Pegaptanib)|Pegaptanib 0.3 mg by intravitreal injection once pre-operatively.
16326942|NCT00446368|Drug|RAD001|Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
16326943|NCT00446342|Drug|SNS-032 Injection|"Stage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle
~Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1"
16326944|NCT00446329|Drug|cinacalcet|Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.
16326945|NCT00446316|Drug|Antacids (Mg-Al-based)|the antacid (Maximum Strength Maalox®Max® Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide).
16326946|NCT00446316|Drug|Imatimib Mesylate (Gleevec®)|Gleevec® will be administered at a dose of 400 mg. Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The antacids will be administered 15 minutes before the Gleevec® dose.
16326947|NCT00446303|Drug|Azacitidine|"Azacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study.
~Extension of maintenance in responders after 24 courses until relapse or death."
16326948|NCT00446290|Drug|Docetaxel, Capecitabine and Oxaliplatin|
16326949|NCT00446277|Procedure|cataract surgery|
16326950|NCT00446264|Procedure|islet transplantation|Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
16326951|NCT00446264|Drug|daclizumab - sirolimus - tacrolimus|Immunosuppressive consisted of Tacrolimus, target through level at 3-6 ng/ml, Sirolimus, target through level at 12-15 ng/ml for three months and at 7-10 ng/ml thereafter. A five-dose induction course of Daclizumab 1mg/Kg was administered biweekly beginning one hour prior to the first infusion
16326952|NCT00446251|Drug|Rituximab|Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15).
16326953|NCT00446251|Drug|Mycophenolate mofetil (MMF)|Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.
16326954|NCT00446238|Behavioral|Cognitive Behavioral Therapy|CBT enhanced with physical illness narrative, family education, and social skills components.
16326955|NCT00446238|Behavioral|Standard of Community Care Treatment|Treatment as usual for depression and related symptoms provided within the community.
16326956|NCT00446225|Drug|Erlotinib (Tarceva)|150 mg/day
16326957|NCT00446225|Drug|Carboplatin // Gemcitabine // Docetaxel //Cisplatin|Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2); Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8); Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)
16326958|NCT00446212|Drug|Propofol|target controlled infusion of propofol
16326959|NCT00446212|Drug|desflurane|Anaesthetic maintenance with desflurane
16326960|NCT00446199|Drug|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
16326961|NCT00446199|Drug|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
16326962|NCT00446199|Drug|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
16326963|NCT00446199|Drug|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
16326964|NCT00446186|Drug|MK0476, montelukast sodium / Duration of Treatment: 2 Weeks|
16326965|NCT00446186|Drug|Comparator: placebo / Duration of Treatment: 2 Weeks|
16326966|NCT00446173|Drug|Busulfan|130 mg/m^2 IV Daily Over 3 Hours x 4 Days
16326967|NCT00446173|Drug|Cyclophosphamide|60 mg/kg IV Daily Over 4 Hours x 2 Days
16326968|NCT00446173|Drug|G-CSF|10 mcg/kg Subcutaneously Once Daily
16326969|NCT00446173|Drug|GM-CSF|250 mcg/kg Subcutaneously Once Daily
16326970|NCT00446147|Drug|Pyridoxine|100mg BID/daily, Per oral
16326971|NCT00446147|Drug|Placebo|placebo 100mg BID/daily, Per oral
16327012|NCT00445887|Other|Laboratory Biomarker Analysis|Correlative studies
16327013|NCT00445887|Drug|Levonorgestrel|Given orally
16326972|NCT00446134|Drug|Taribavirin|Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
16326973|NCT00446134|Drug|Taribavirin|Oral (200 mg) Tablet: 25mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
16326974|NCT00446134|Drug|Taribavirin|Oral (200mg)Tablet: 30mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
16326975|NCT00446134|Drug|Ribavirin|Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.
16326976|NCT00446095|Drug|fostamatinib|200 mg PO BID
16326977|NCT00446082|Drug|Pasireotide|
16326978|NCT00446069|Drug|Morphine Sulphate|Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
16326979|NCT00446056|Drug|MK0476, montelukast sodium / Duration of Treatment: 4 Weeks|
16326980|NCT00446056|Drug|Comparator: ketotifen / Duration of Treatment: 4 Weeks|
16326981|NCT00446043|Drug|Adapalene/Benzoyl Peroxide|
16326982|NCT00446030|Drug|Docetaxel|"75 mg/m^2 administered IV on Day 1 for Cycles 1-6
~All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg)."
16326983|NCT00446030|Drug|Doxorubicin|50 mg/m^2 administered IV on Day 1 for Cycles 1-6
16326984|NCT00446030|Drug|Carboplatin|6 mg/mL/min (target area under the curve [AUC] dose) administered IV on Day 1 for Cycles 1-6
16326985|NCT00446030|Drug|Cyclophosphamide|500 mg/m^2 administered IV on Day 1 for Cycles 1-6
16326986|NCT00446030|Drug|Trastuzumab|A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy
16326987|NCT00446030|Drug|Bevacizumab|15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy
16326988|NCT00446017|Drug|adrenaline|
16326989|NCT00446017|Drug|milrinone|
16326990|NCT00446004|Drug|Imatinib Mesylate|Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
16326991|NCT00446004|Drug|Omeprazole|Dosage form: capsules Dosage: 40 mg Frequency: On an 18-day schedule, once daily day 10 through day 16 (for Arm A); or once daily day -4 through day 1 (for Arm B)
16326992|NCT00445978|Drug|Sapropterin Dihydrochloride|Subjects will receive oral, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Dosing was with 100 mg tablets and rounded to the nearest whole tablet. Each dose was taken within 1 hour after the morning meal. Subjects may continue in an optional extension phase at the highest tolerated dose for up to a total of 2 years.
16326993|NCT00445965|Genetic|DNA analysis|
16326994|NCT00445965|Other|immunologic technique|
16326995|NCT00445965|Other|pharmacological study|
16326996|NCT00445965|Radiation|iodine I 131 monoclonal antibody 3F8|
16326997|NCT00445965|Radiation|131I-3F8|Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
16326998|NCT00445952|Other|clinical observation|
16326999|NCT00445952|Procedure|management of therapy complications|
16327000|NCT00445939|Biological|adalimumab|160 mg at Week 0, 80 mg at Week 2
16327001|NCT00445939|Biological|adalimumab|80 mg at Week 0, 40 mg at Week 2
16327002|NCT00445939|Biological|placebo|Placebo at Week 0 and Week 2
16327003|NCT00445926|Device|deep TMS H-coil|
16327004|NCT00445913|Biological|Diabetes-suppressive dendritic cell vaccine|The dendritic cells will be treated ex vivo with the antisense oligonucleotides and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to the dendritic cell vaccine will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
16327005|NCT00445913|Biological|control dendritic cells|The dendritic cells will be treated ex vivo with vehicle and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to these control dendritic cells will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
16327006|NCT00445900|Drug|cyclophosphamide|
16327007|NCT00445900|Drug|prednisone|
16327008|NCT00445900|Drug|thalidomide|
16327009|NCT00445900|Other|immunohistochemistry staining method|
16327014|NCT00445887|Other|Placebo|Given orally
16327015|NCT00445874|Drug|Ketotifen with a Contact Lens (no generic name)|
16327016|NCT00445861|Biological|cetuximab + docetaxel + cisplatin|Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.
16327017|NCT00445861|Biological|Treatment level 1|Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.
16327018|NCT00445861|Biological|Treatment level 2|Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.
16327019|NCT00445861|Procedure|conventional surgery|Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.
16327020|NCT00445848|Biological|bevacizumab|
16327021|NCT00445848|Drug|erlotinib hydrochloride|
16327022|NCT00445835|Other|Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds|A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis
16327023|NCT00445835|Other|Conservative arm|Conservative medical approach
16327024|NCT00445796|Drug|Artesunate|
16327025|NCT00445796|Drug|Amodiaquine|
16327026|NCT00445783|Genetic|gene expression analysis|
16327027|NCT00445783|Genetic|mutation analysis|
16327028|NCT00445783|Other|immunohistochemistry staining method|
16327029|NCT00445783|Other|laboratory biomarker analysis|
16327030|NCT00445783|Procedure|examination|
16327031|NCT00445783|Procedure|mutation carrier screening|
16327032|NCT00445783|Procedure|study of high risk factors|
16327033|NCT00445770|Drug|Etanercept|10 mg twice weekly, subcutaneous injection for 52 weeks
16327034|NCT00445770|Drug|Etanercept|25 mg, twice weekly, subcutaneous injection for 52 weeks
16327035|NCT00445770|Drug|Methotrexate|up to 8 mg per week, oral dosing for 52 weeks
16327036|NCT00445757|Procedure|conventional surgery|Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
16327037|NCT00445757|Radiation|stereotactic radiosurgery|Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached.
16327038|NCT00445744|Drug|cyclophosphamide|Given IV
16327039|NCT00445744|Drug|busulfan|Given IV
16327040|NCT00445744|Drug|tacrolimus|Given IV or PO
16327041|NCT00445744|Drug|methotrexate|Given IV
16327042|NCT00445744|Genetic|cytogenetic analysis|Correlative studies
16327043|NCT00445744|Other|flow cytometry|Correlative studies
16327044|NCT00445744|Other|pharmacological study|Correlative studies
16327045|NCT00445744|Other|pharmacogenomic studies|Correlative studies
16327046|NCT00445744|Procedure|peripheral blood stem cell transplantation|Undergo PBPC transplantation
16327047|NCT00445744|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
16327048|NCT00445731|Behavioral|exercise intervention|
16327049|NCT00445731|Procedure|management of therapy complications|
16327050|NCT00445731|Procedure|observation|
16327051|NCT00445718|Procedure|computed tomography|
16327052|NCT00445718|Procedure|3-Tesla magnetic resonance imaging|
16327053|NCT00445718|Procedure|Abdominal Sonogram|Sonogram of the abdomen area
16327054|NCT00445705|Drug|placebo|Part A: Placebo every 12 hours for 4 weeks
16327055|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 3 mg every 12 hours for 4 weeks
16327056|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 20 mg every 12 hours for 4 weeks
16327057|NCT00445705|Drug|AGN 203818|Part A: AGN 203818 60 mg every 12 hours for 4 weeks
16327058|NCT00445692|Drug|Clarithromycin|Given Orally (PO)
16327059|NCT00445692|Drug|Dexamethasone|Given PO
16327060|NCT00445692|Drug|Lenalidomide|Given Orally (PO)
16327061|NCT00445679|Drug|DVS SR|Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
16327062|NCT00445679|Drug|Paroxetine|20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
16327063|NCT00445614|Behavioral|Effects of trout on CVD risk markers and plasma proteome|
16327064|NCT00445601|Drug|gemcitabine hydrochloride|Given intravesically
16327065|NCT00445601|Other|placebo|Given intravesically
16327066|NCT00445588|Drug|erlotinib hydrochloride|150mg Given orally once daily
16327067|NCT00445588|Drug|sorafenib tosylate|400mg Given orally twice daily
16327068|NCT00445588|Other|pharmacological study|Correlative studies
16327069|NCT00445575|Drug|risedronate|During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
16327070|NCT00445575|Drug|placebo|placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
16327071|NCT00445575|Drug|risedronate|During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
16327072|NCT00445575|Drug|placebo|placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
16327073|NCT00445562|Other|biologic sample preservation procedure|
16327074|NCT00445562|Other|informational intervention|
16327075|NCT00445549|Drug|Vandetanib|300 mg daily dose, 28 day cycle
16327076|NCT00445523|Biological|TroVax® (Immunological Vaccine Therapy)|16 Intramuscular injections of TroVax® over 47 weeks
16327077|NCT00445523|Drug|Interferon-alpha|36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)
16327079|NCT00445497|Drug|amoxicillin-clavulanate potassium|
16327080|NCT00445497|Drug|ciprofloxacin|
16327081|NCT00445497|Procedure|psychosocial assessment and care|
16327082|NCT00445497|Procedure|quality-of-life assessment|
16327083|NCT00445484|Biological|pneumococcal polyvalent vaccine|Given intramuscularly
16327084|NCT00445484|Drug|lenalidomide|Given orally
16327085|NCT00445471|Behavioral|Mifne Approach to PDD|
16327086|NCT00445471|Behavioral|Treatment as usual|
16327087|NCT00445458|Drug|HKI-272|
16327088|NCT00445458|Drug|Paclitaxel|
16327089|NCT00445445|Other|physiologic testing|Urine samples will be assessed for levels of bisphenol-A
16327090|NCT00445445|Other|screening questionnaire administration|Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
16327091|NCT00445445|Procedure|breast imaging study|Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
16327092|NCT00445445|Procedure|radiomammography|Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
16327093|NCT00445445|Procedure|study of high risk factors|"Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
~Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis."
16327094|NCT00445432|Biological|adalimumab|Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)
16327095|NCT00445432|Other|Placebo|Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)
16327096|NCT00445419|Biological|PEV2A PEV2B|
16327097|NCT00445406|Drug|bevacizumab + doxorubin hydrochloride liposme|Patients receive bevacizumab IV over 30-90 minutes and doxorubicin hydrochloride liposome IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses
16327098|NCT00445406|Drug|Bevacizumab|Patients then receive bevacizumab alone IV over 30-90 minutes on days 1 and 15. Courses with bevacizumab repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
16327099|NCT00445354|Drug|cinnamon|
16327100|NCT00445341|Drug|Flavopiridol|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
16327101|NCT00445328|Drug|Dalteparin (Fragmin)|Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
16327102|NCT00445328|Drug|Unfractionated heparin|Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
16327103|NCT00445315|Drug|PF-00868554|300 mg BID
16327104|NCT00445315|Drug|PF-00868554|450 mg BID
16327105|NCT00445315|Drug|PF-00868554|100 mg BID
16327106|NCT00445315|Drug|PF-00868554|300 mg TID
16327107|NCT00445315|Drug|Placebo|Placebo
16327108|NCT00445302|Drug|plerixafor|Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection
16327109|NCT00445289|Device|SmartCare/PS|
16327110|NCT00445276|Drug|Diacerein|
16327111|NCT00445263|Drug|TIROFIBAN|intravenous infusion
16327112|NCT00445263|Procedure|CORONAROGRAPHY|standard procedure of coronarography
16327113|NCT00445250|Drug|Calcipotriol|
16327114|NCT00445237|Device|H1 and H2 deep TMS coils|
16327115|NCT00445224|Other|Hip Progressive Resistive Exercise|Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.
16327116|NCT00445224|Other|Quad Progressive Resistive Exercises|Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.
16327117|NCT00445211|Drug|Heparin|Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
16327118|NCT00445211|Other|Without Heparin|Intra-Aortic balloon Pump (IABP) without Heparin.
16327119|NCT00445198|Drug|ABT-263|"Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.
~- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study.
~Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.
~- 40 patients with SCLC"
16327120|NCT00445185|Biological|Henogen HB vaccine|Month 12, 24 and 36
16327121|NCT00445185|Biological|Fendrix vaccine|Month 12, 24 and 36
16327122|NCT00445172|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin twice a week.
16327123|NCT00445159|Drug|UT-15C SR (treprostinil diethanolamine) 1mg oral tablets|
16327124|NCT00445146|Drug|EVG|Elvitegravir (EVG) tablet administered orally once daily with food
16327125|NCT00445146|Drug|RTV|Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
16327126|NCT00445146|Drug|ARV regimen|The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
16327127|NCT00445133|Device|Magnetic Sleep Pad|
16327128|NCT00445120|Drug|Lactobacillus Rhamnosus GG|patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months
16327129|NCT00445120|Drug|placebo (sugar)|Placebo will be administered to patients once daily for six months
16327130|NCT00445107|Drug|MK0476, montelukast sodium / Duration of Treatment: 8 Weeks|
16327131|NCT00445094|Drug|MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days|
16327132|NCT00445094|Drug|Comparator: amikacin / Duration of Treatment: 3 Days|
16327133|NCT00445094|Drug|Comparator: tazocin / Duration of Treatment: 3 Days|
16327134|NCT00445094|Drug|Comparator: vancomycin / Duration of Treatment: 3 Days|
16327135|NCT00445081|Drug|Prednisolone|
16327136|NCT00445081|Drug|Ciclosporine A|
16327137|NCT00445068|Drug|LBH589|
16327138|NCT00445055|Drug|Droperidol|Intravenous injection
16327139|NCT00445042|Drug|Sorafenib|The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the protocol, providing no dose limiting toxicity (Grade 3 or 4) is observed.
16327140|NCT00445016|Procedure|peripheral regional anesthesia|evaluation and description of adverse effects
16327141|NCT00445003|Drug|Ranibizumab|Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks
16327142|NCT00445003|Drug|Triamcinolone Acetonide|Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
16327143|NCT00445003|Behavioral|Sham injection|Sham injection at baseline and 4 weeks
16327144|NCT00445003|Procedure|Focal/grid laser|Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
16327145|NCT00444990|Device|Magnetic Flex Pad|
16327146|NCT00444977|Behavioral|Case-management linkage intervention|dental care
16327147|NCT00444964|Drug|Nutropin AQ|0.0125 mg/kg/day
16327148|NCT00444951|Biological|Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine|0.5 mL, Intramuscular
16327149|NCT00444951|Biological|Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine|0.5 mL, Subcutaneous
16327150|NCT00444951|Biological|Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine|0.5 mL, Intramuscular
16327151|NCT00444938|Device|H1 -coil TMS device|
16327152|NCT00444925|Drug|fesoterodine fumarate|4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
16327153|NCT00444925|Drug|placebo|once daily (OD)for 12 weeks
16327154|NCT00444925|Drug|tolterodine tartrate|4 mg once daily (OD) for 12 weeks
16327155|NCT00444912|Drug|G-CSF plus plerixafor|Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
16327156|NCT00444912|Drug|G-CSF plus plerixafor|Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5*10^6 CD34+ cells/kg were collected.
16327157|NCT00444912|Biological|rituximab|Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF.
16327158|NCT00444899|Behavioral|Intensive treatment|Subjects will be followed by the dietician in combination with his/her endocrinologist. Diet, physical activity, smoking cessation and drug prescriptions will be used to treat subjects.
16327159|NCT00444899|Other|Normal follow-up|Subject will continue to be followed by their endocrinologist and general practitioner as they already do.
16327160|NCT00444886|Drug|Botulinum Toxin Type A injection (BOTOX)|Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
16327161|NCT00444886|Drug|Botulinum Toxin Type A injection (BOTOX)|Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
16327162|NCT00444873|Drug|lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval|Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
16327163|NCT00444860|Biological|Zoster Vaccine, Live, (Oka-Merck)|A single dose of 0.65 ml of Zostavax injection was given to each study subject
16327164|NCT00444847|Device|Hyperbaric chamber|
16327165|NCT00444834|Drug|Carvedilol|50 mg
16327166|NCT00444821|Device|AneuRx AAA stent graft / Talent AAA stent graft|Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
16327167|NCT00444808|Drug|Intranasal calcitonin|
16327168|NCT00444795|Drug|Sunitinib malate|Sunitinib : dosing not pre-determined
16327169|NCT00444795|Drug|Sunitinib malate|Sunitinib : dosing not pre-determined
16327170|NCT00444795|Drug|sunitinib malate|Sunitinib : dosing not pre-determined
16327171|NCT00444782|Biological|GV1001|
16327172|NCT00444769|Drug|GW842166|
16327173|NCT00444756|Procedure|J-tip jet injection of 1% buffered lidocaine|
16327174|NCT00444743|Drug|MM-093|60 mg, administered subcutaneously, weekly
16327175|NCT00444743|Other|Placebo|Placebo
16327176|NCT00444730|Procedure|Radical Prostatectomy|Surgical procedure for prostate cancer.
16327177|NCT00444730|Procedure|InterStim Implantation|surgical placement of the interstim
16327178|NCT00444730|Procedure|Pelvic organ prolapse repair|Surgical pelvic organ prolapse repair
16327179|NCT00444717|Drug|pitavastatin|Pitavastatin (2mg/day) was administered for 12 weeks
16327180|NCT00444704|Drug|PRA-027|
16327181|NCT00444691|Device|ultra-sonography|"o The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz).
~The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline."
16327182|NCT00444678|Drug|Cetuximab|500 mg/m2, IV every two weeks
16327183|NCT00444678|Drug|Oxaliplatin|85 mg/m2, IV, q 2 weeks
16327184|NCT00444678|Drug|Capecitabine|2500 mg, po bid x 7 days every two weeks
16327185|NCT00444665|Drug|Travatan-Z|
16327186|NCT00444652|Drug|Enoxaparin|injection of enoxaparin a few time
16327187|NCT00444639|Drug|Triptorelin (Decapeptyl®)|Two injections of 11.25mg given every 12 weeks
16327188|NCT00444626|Device|Dermal Gel Extra (DGE)|Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.
16327189|NCT00444626|Device|Restylane|Restylane was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of Restylane to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period.
16327190|NCT00444626|Drug|EMLA Cream|EMLA Cream (Eutectic Mixture of Local Anesthetics) is an FDA-approved topical anesthetic comprised of 2.5% each of lidocaine/prilocaine. EMLA Cream was applied in approximately equal amounts prior to all injections of DGE and Restylane.
16327191|NCT00444613|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
16327192|NCT00444613|Drug|E0302 (mecobalamin)|Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
16327193|NCT00444613|Drug|Placebo|Intramuscular injection, placebo twice a week for 3.5 years.
16327194|NCT00444600|Drug|Triamcinolone Acetonide + laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
16327195|NCT00444600|Drug|Ranibizumab + laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
16327196|NCT00444600|Drug|Sham injection + laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
16327197|NCT00444600|Drug|Ranibizumab + deferred laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
16327198|NCT00444587|Drug|Second line chemotherapy|As prescribed
16327199|NCT00444587|Drug|trastuzumab [Herceptin]|6mg/kg iv every 3 weeks
16327200|NCT00444574|Drug|Methylphenidate Transdermal System|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
16327201|NCT00444574|Drug|Placebo|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
16327202|NCT00444574|Drug|Concerta|The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
16327203|NCT00444561|Drug|pramlintide acetate|Clear, colorless, sterile solution for SC administration
16327204|NCT00444548|Drug|[S,S]-Reboxetine|
16327207|NCT00444522|Drug|Alprazolam thermal aerosol|
16327208|NCT00444509|Drug|GW685698X|GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
16327209|NCT00444509|Drug|GW685698X containing magnesium stearate|GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
16327210|NCT00444483|Behavioral|Structured diabetes teaching and treatment program|
16327211|NCT00444470|Drug|Tranexamic acid|"Eligible patients who have consented to be in the study and have been randomised to be in Arm A will receive 10 mg/kg of tranexamic acid, and then a continuous infusion of 1 mg/kg/hr of tranexamic acid."
16327212|NCT00444470|Drug|Placebo|"Eligible patients who have consented to be in the study and have been randomised to be in Arm B will receive 10 mg/kg of placebo followed by a continuous infusion of 1 mg/kg/hr of placebo."
16327213|NCT00444457|Biological|13-valent Pneumococcal Conjugate Vaccine|0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
16327214|NCT00444457|Biological|7vPnC|0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
16327215|NCT00444431|Procedure|Pyeloplasty|
16327216|NCT00444418|Drug|Naltrexone|Naltrexone, 100 mg. oral dosage, daily for 12 weeks.
16327217|NCT00444418|Behavioral|Modified Behavioral Self-Control Psychotherapy|Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
16327218|NCT00444418|Behavioral|Brief Behavioral Compliance Enhancement Therapy|Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
16327219|NCT00444392|Behavioral|Calorie controlled diabetic diet for the control patients|Calorie controlled diabetic diet for the control patients
16327357|NCT00020267|Drug|MAGE-12 peptide vaccine|
16327358|NCT00020267|Drug|Montanide ISA-51|
16327220|NCT00444379|Drug|Lopinavir/ritonavir plus Emtricitabine/Tenofovir versus Efavirenz plus Emtricitabine/Tenofovir|Lopinavir/ritonavir 200/50mg plus Emtricitabine/Tenofovir 200/300mg versus Efavirenz 600mg plus Emtricitabine/Tenofovir 200/300mg
16327221|NCT00444353|Device|DL6049 (injectable poly-L-lactic acid)|
16327222|NCT00444340|Drug|Enbrel (Etanercept)|
16327223|NCT00444314|Drug|Panzem® NCD|NCD suspension, 1500 mg TID daily for 6 week cycles
16327224|NCT00444314|Drug|Sunitinib Malate|Sunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
16327225|NCT00444275|Drug|esomeprazole (Nexium®)|"This randomized study was conducted on parallel groups and included two phases:
~One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
~One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed"
16327226|NCT00444275|Drug|Xolaam®|"This randomized study was conducted on parallel groups and included two phases:
~One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
~One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed"
16327227|NCT00444262|Procedure|hemodynamic optimisation guided using esophageal Doppler|hemodynamic optimisation guided using esophageal Doppler
16327228|NCT00444262|Drug|VOLUVEN and others solute|VOLUVEN and others solute
16327229|NCT00444249|Procedure|White Alcon IOL|Implantation of white Alcon IOL
16327230|NCT00444249|Procedure|Yellow Alcon IOL|Implantation of yellow Alcon IOL
16327231|NCT00444249|Procedure|White Hoya IOL|Implantation of white Hoya IOL
16327232|NCT00444249|Procedure|Yellow Hoya IOL|Implantation of yellow Hoya IOL
16327233|NCT00444236|Drug|Nexium|nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
16327234|NCT00444236|Drug|Placebo|matching placebo for active drug
16327235|NCT00444223|Procedure|fluorine F 18 FEQA + positron emission tomography|
16327236|NCT00444210|Device|DL6049 (injectable poly-L-lactic acid)|
16327237|NCT00444197|Behavioral|Mentoring and violence prevention curriculum with parental monitoring|
16327238|NCT00444184|Drug|Travoprost/timolol fixed combination, travoprost|
16327239|NCT00444171|Procedure|insulin infusion rate controled by computer algorithm|
16327240|NCT00444171|Procedure|insulin infusion rate guided by in-house glucose management protocol|
16327241|NCT00444158|Drug|MOA-728|
16327242|NCT00444145|Drug|Prevacid|30 mg bid for 3 months
16327243|NCT00444145|Procedure|Esophageal and Laryngeal Biopsies|repeat egd with biopsy after Prevacid 30 mg bid for 3 months
16327244|NCT00444132|Drug|clopidogrel|
16327245|NCT00444106|Drug|Artesunate-mefloquine|
16327246|NCT00444106|Drug|Atovaquone-proguanil|
16327247|NCT00444106|Drug|Artemether-lumefantrine|
16327248|NCT00444093|Drug|Opii normata treatment|"After beginning of diarrhea grade 1:
~5 drops tincture of opium three times a day
~After beginning of diarrhea grade 2:
~Intensive therapy with 15 drops tincture of opium three times a day."
16327249|NCT00444093|Drug|Loperamid Treatment|"All patients who receive as a result of randomisation loperamide
~After beginning of diarrhea grade 1:
~Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day.
~After beginning of diarrhea grade 2:
~Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day."
16327250|NCT00444080|Procedure|Trabeculectomy|"Standard trabeculectomy procedure
~Creation of a fornix or limbal based conjunctival flap in upper quadrants
~Creation of a limbal-based scleral flap extending into clear cornea
~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
~Creation of fistula 1mm x 2mm in size
~Iridectomy
~Suturing the scleral flap
~Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged."
16327251|NCT00444080|Device|Ex-PRESS mini shunt|"Ex-PRESS implantation procedure:
~Creation of a fornix or limbal based conjunctival flap in upper quadrants
~Creation of limbal-based scleral flap extending into clear cornea
~Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
~Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus
~Prior to implantation, a thorough mobility check should be performed
~Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
~Withdrawal of introducer
~Tucking plate under the scleral flap, and verification of its position
~Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged."
16327252|NCT00444067|Device|Spinal Sealant|Spinal Sealant System
16327253|NCT00444067|Other|Standard of Care|Standard of Care
16327254|NCT00444054|Behavioral|Very low carbohydrate diet (approximately 20 grams per day)|Very low carbohydrate diet for a duration of four weeks.
16327255|NCT00444041|Drug|Bevacizumab|neoadjuvant therapy prior to elective surgery
16327256|NCT00444028|Drug|inhaled Loxapine 0.625 mg|Single 0.625 mg (lowest) dose of inhaled loxapine
16327257|NCT00444028|Drug|inhaled Loxapine 1.25 mg|Single 1.25 mg (2nd) dose of inhaled loxapine
16327258|NCT00444028|Drug|inhaled Loxapine 2.5 mg|Single 2.5 mg (3rd) dose of inhaled loxapine
16327259|NCT00444028|Drug|inhaled Loxapine 5 mg|Single 5 mg (4th) dose of inhaled loxapine
16327260|NCT00444028|Drug|inhaled Loxapine 10 mg|Single 10 mg (5th) dose of inhaled loxapine
16327261|NCT00444028|Drug|inhaled Placebo (0 mg)|Single placebo dose of inhaled loxapine
16327262|NCT00444015|Drug|Erlotinib in combination with Dasatinib|6 Cycles @ 28 Days
16327263|NCT00443976|Drug|Aurora kinase inhibitor AT9283|The starting dose of AT9283 will be 1.5 mg/m2 given as a 24 hour IV infusion on Days 1 and 8 every three weeks.
16327264|NCT00443963|Drug|Esomeprazole Magnesium|PPI compared to H2RA
16327265|NCT00443950|Drug|Etanercept|
16327266|NCT00443937|Drug|enteric-coated mycophenolate sodium|oral
16327267|NCT00443937|Drug|everolimus|oral
16327359|NCT00443326|Drug|AMG 714|Dosing Regimen is 6 Doses over 3 Months
16327268|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
16327269|NCT00443924|Drug|Placebo|One drop of placebo in each eye every 12 hours for three days
16327270|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
16327271|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
16327272|NCT00443924|Drug|INS115644 Ophthalmic Solution|One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
16327273|NCT00443898|Drug|terbinafine|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
16327274|NCT00443898|Drug|Placebo|vehicle (placebo) applied once daily for 48 weeks
16327275|NCT00443898|Drug|terbinafine|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
16327276|NCT00443898|Drug|Placebo|vehicle (placebo) applied once daily for 24 weeks
16327277|NCT00443872|Drug|orally disintegrating selegiline (Zelapar)|1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated
16327278|NCT00443846|Biological|RotaTeq®|Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
16327279|NCT00443846|Biological|NeisVac-C®|Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
16327280|NCT00443820|Drug|terbinafine|Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
16327281|NCT00443820|Drug|Placebo|Vehicle (placebo) once daily for 48 weeks
16327282|NCT00443820|Drug|terbinafine|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
16327283|NCT00443820|Drug|Placebo|Vehicle (placebo) once daily for 24 weeks
16327284|NCT00443807|Device|On-line EEG monitoring during neurosurgery|Comparison of 2 ways of processing the EEG signal
16327285|NCT00443807|Device|EEGo vs BIS|comparison of two processed EEG monitors.
16327286|NCT00443794|Drug|Thiazides|Capsule (blinded) oral administration once daily for 12 weeks
16327287|NCT00443794|Drug|Ramipril with Thiazide|Capsule (blinded) oral administration 12 weeks
16327288|NCT00443794|Drug|Thiazide plus atenolol|Caspule (blinded) for oral administration once daily for 12 weeks
16327289|NCT00443794|Drug|Ramipril plus atenolol|Capsule ( blinded) for oral administration once daily for 12 weeks
16327290|NCT00443794|Drug|Ramipril plus atenolol plus thiazide|Capsule (blinded) for oral administration once daily for 12 weeeks
16327291|NCT00443794|Drug|POLYCAP|Capsule for Oral Administration once daily for 12 weeks
16327292|NCT00443794|Drug|Thiazide + Ramipril+Atenolol+Aspirin|Capsule (Blinded) for oral administration once daily for 12 weeks
16327293|NCT00443794|Drug|Simvastatin|Capsule (Blinded) for oral administration once daily for 12 weeks
16327294|NCT00443794|Drug|aspirin|capsule (Blinded) for oral administration once daily for 12 weeks
16327295|NCT00443781|Procedure|functional anesthetic discography|Functional Anesthetic Discography (F.A.D.) involves the placement and anchoring of a small catheter into a disc. After placement, functional testing is performed, in which the subject elicits his/her back pain via functional maneuvers or postures. Local anaesthetic is then delivered into the target disc through the catheter and the effect on functional back pain is noted.
16327296|NCT00443781|Procedure|provocative discography|"Provocative discography (PD) has been used as a preoperative diagnostic tool for patients with back pain attributed to degenerative disc disease considering lumbar disc surgery. During PD, a clinically suspected disc is accessed with a needle and injected under pressure with radiopaque contrast dye. The subject rates his/her experience of pain for intensity and whether the pain is exactly the same as (concordant) or different from (not concordant or discordant) typical back pain."
16327297|NCT00443755|Drug|metformin|To minimize side effects the metformin will be initiated at 500 mg twice daily with meals and increased to 1 gm twice daily with meals after two weeks and continue to a total of 3 months of dosing.
16327298|NCT00443755|Drug|pioglitazone|To minimize side effects, the pioglitazone will be initiated at 30 mg daily and increased to 45 mg daily after two weeks, and continue to a total of 3 months of dosing.
16327299|NCT00443755|Drug|Placebo|Placebo tablets matching the metformin and pioglitazone tablets are given in the same regimen as the active drug arm for 3 months.
16327300|NCT00443742|Procedure|Validation|
16327301|NCT00443729|Drug|Comparator: raltegravir|raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
16327302|NCT00443729|Drug|Comparator: placebo|lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
16327303|NCT00443729|Drug|Comparator: lopinavir (+) ritonavir|lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment
16327304|NCT00443729|Drug|Comparator: placebo|raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
16327305|NCT00443716|Drug|estrogen|
16327306|NCT00443703|Drug|MK0518 (raltegravir)|MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
16327307|NCT00443703|Drug|Comparator: KALETRA™ (lopinavir (+) ritonavir )|KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
16327308|NCT00443703|Drug|Comparator: placebo|MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
16327309|NCT00443703|Drug|Comparator: placebo|KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
16327310|NCT00443690|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
16327311|NCT00443690|Drug|Comparator: Placebo (unspecified)|rolofylline Pbo 30 mg IV QD; 3 days
16327312|NCT00443677|Drug|COPPEBVCAD vs BEACOPP vs ABVD|
16327313|NCT00443664|Device|EXTERNAL MICROPULSE DIODE LASER TRANSSCLERAL TRABECULOPLASTY|
16327314|NCT00443651|Drug|Rituximab|Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials.
16327360|NCT00443287|Drug|ataciguat (HMR1766)|oral administration
16327315|NCT00443651|Drug|Anti-inflammatory drugs|Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs).
16327316|NCT00443638|Behavioral|nurse home visitation|Nurse home visitation
16327317|NCT00443625|Drug|SK3530|
16327318|NCT00443612|Drug|Irbesartan/Hydrochlorothiazide|Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
16327319|NCT00443612|Drug|Irbesartan|Administration of irbesartan 150 mg/day
16327320|NCT00443599|Drug|Insulin|Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
16327321|NCT00443599|Other|Usual Care|Participants receive standard Cardiac ICU care without tight blood glucose control.
16327322|NCT00443586|Behavioral|Developmental Screening|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
16327323|NCT00443586|Behavioral|Screening plus Transportation|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
16327324|NCT00443586|Behavioral|Screening, Transport, Prenatal Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
16327325|NCT00443586|Behavioral|Screen, Transport, Prenatal/Inf Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.
16327326|NCT00443573|Drug|recombinant nematode anticoagulant protein c2 (rNAPc2)|escalating dose administered 2x/week sq.
16327327|NCT00443560|Other|Case controlled analysis of epidural labor analgesia patterns|A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
16327328|NCT00443547|Device|Vectra-T|Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
16327329|NCT00443534|Drug|SU011248|Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol
16327330|NCT00443521|Drug|Triamcinolone Acetonide 4 mg intravitreal injection|
16327331|NCT00443521|Procedure|Panretinal photocoagulation|
16327332|NCT00443508|Drug|adding Certican to therapy|
16327333|NCT00443508|Drug|reducing Tacrolimus|
16327334|NCT00443495|Drug|Chitin microparticles by nasal route|
16327335|NCT00443482|Drug|formoterol|
16327336|NCT00443469|Device|magnetic stimulation|SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.
16327337|NCT00443469|Device|Magnetic Stimulation with tilted coil|The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.
16327338|NCT00443456|Drug|Amlodipine|Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
16327339|NCT00443430|Drug|methotrexate|Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone
16327340|NCT00443430|Drug|methotrexate - etanercept - prednisolone arm|methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
16327341|NCT00443417|Drug|SK-PC-B70M|dosage, frequency
16327342|NCT00443404|Procedure|perioperative epidural catheter|Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control)
16327343|NCT00443391|Drug|ABT-089|Open label study, subjects will take up to 80mg daily for 24 months.
16327344|NCT00443378|Behavioral|CARE+|CARE+ is a .NET based application on tablet computers that comprises risk assessment, medication monitoring, tailored feedback, stage-based skills-building videos, motivational interviewing counseling, an integrated health promotion plan, and printout with referrals. Evidence-based approaches (pharmacist education, self-efficacy/importance scaling exercises, and consequence-framing) are incorporated.
16327345|NCT00443365|Procedure|Mitral valve repair|mitral valve annuloplasty
16327346|NCT00443352|Drug|duloxetine|Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
16327347|NCT00443339|Drug|Darbepoetin|
16327348|NCT00020475|Drug|gp100 antigen|
16327349|NCT00020475|Drug|interleukin-2|
16327350|NCT00020475|Drug|MART-1 antigen|
16327351|NCT00020475|Drug|Montanide ISA-51|
16327352|NCT00020371|Drug|BMS-247550|
16327353|NCT00020371|Drug|filgrastim|
16327354|NCT00020345|Drug|fluorouracil|
16327355|NCT00020345|Drug|gemcitabine|
16327356|NCT00020267|Drug|interleukin-2|
16327361|NCT00443287|Drug|placebo|oral administration
16327362|NCT00443287|Drug|cilostazol|oral administration
16327363|NCT00443274|Other|NBIR Placeholder|
16327364|NCT00443274|Device|410 Arm|
16327365|NCT00443274|Device|BIFs|
16327366|NCT00443261|Drug|Azacitidine|SC azacitidine
16327367|NCT00443261|Drug|Cisplatin|cisplatin 75 mg/m^2 day 8 every 28 days
16327368|NCT00443248|Device|Vaginal Heat Wash-Out Device|No drug administered. Device tested twice with each subject.
16327369|NCT00443235|Drug|Melphalan/Prednisone/Velcade|"One cycle:
~Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)"
16327370|NCT00443235|Drug|Thalidomide/Prednisone/Velcade|"One cycle:
~Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)
~Five cycles:
~Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)"
16327371|NCT00443222|Drug|Infliximab|
16327372|NCT00443209|Drug|Telcagepant 300 mg soft gel capsules|One capsule taken orally at onset of migraine
16327373|NCT00443209|Drug|Telcagepant 280 mg tablets|One tablet taken orally at onset of migraine
16327374|NCT00443209|Drug|Rizatriptan 10 mg tablets|One tablet taken orally at onset of migraine
16327375|NCT00443209|Drug|Placebo to telcagepant capsules|One capsule taken orally at onset of migraine
16327376|NCT00443209|Drug|Placebo to telcagepant tablets|One tablet taken orally at onset of migraine
16327377|NCT00443209|Drug|Placebo to rizatriptan tablets|One tablet taken orally at onset of migraine
16327378|NCT00443196|Procedure|MiCK Assay|Physician determined treatment
16327379|NCT00443183|Behavioral|Brief Negotiation Interview (BNI)|The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.
16327380|NCT00443183|Behavioral|Discharge Instructions|Used as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length.
16327381|NCT00443170|Drug|GSK626616, placebo, midazolam|
16327382|NCT00443170|Drug|omeprazole, caffeine, flurbiprofen, rosiglitazone|
16327383|NCT00443157|Biological|Meningococcal B Vaccine NZ|
16327384|NCT00443144|Drug|recombinant human growth hormone|
16327385|NCT00443131|Biological|GSK Malaria vaccine 257049|Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).
16327386|NCT00443118|Device|T-piece resuscitator Neopuff TM|Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
16327387|NCT00443118|Device|Self Inflating Bag with PEEP|Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
16327388|NCT00443118|Device|Self Inflating Bag without PEEP|Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
16327389|NCT00443105|Drug|Tacrolimus 0.03% ointment (Protopic)|
16327390|NCT00443092|Other|proprietary cherry juice blend (food)|2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
16327391|NCT00443092|Other|control juice (kool aid blend)|2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
16327392|NCT00443079|Drug|IdB 1016 (Siliphos)|1 pill 3 times daily x 6 weeks
16327393|NCT00443079|Drug|Matched placebo|1 pill 3 times daily x 6 weeks
16327394|NCT00443053|Drug|Fondaparinux 2.5mg or placebo|Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
16327395|NCT00443040|Drug|Asimadoline|Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.
16327396|NCT00443040|Drug|Placebo|Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.
16327397|NCT00443027|Device|Vaginal Heat Wash-Out Device|No drug administered. Device tested three times with each subject.
16327398|NCT00443014|Device|Cognitive, physical and social stimulation|Sessions of 30 minutes daily five days a week for one year
16327399|NCT00443001|Device|Non invasive blood pressure monitor|Updated device and software to improve performance in patients with dysrhythmia
16327400|NCT00442975|Biological|Fluarix|
16327401|NCT00442962|Drug|Efavirenz|600-mg tablet taken orally daily
16327402|NCT00442962|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
16327403|NCT00442949|Procedure|Catheterization immediate PCI|Catheterization immediate PCI
16327404|NCT00442949|Procedure|delayed PCI|delayed PCI
16327405|NCT00442936|Drug|Telcagepant potassium 150 mg|Telcagepant 150 mg liquid-filled soft gel capsules
16327406|NCT00442936|Drug|Telcagepant potassium 300 mg|Telcagepant 300 mg liquid-filled soft gel capsules
16327407|NCT00442936|Drug|Zolmitriptan 5 mg|Zolmitriptan 5 mg tablets
16327408|NCT00442936|Drug|Placebo to telcagepant 150 mg|Placebo to match telcagepant 150 mg liquid-filled soft gel capsules
16327409|NCT00442936|Drug|Placebo to tecagepant 300 mg|Placebo to match tecagepant 300 mg liquid-filled soft gel capsules
16327410|NCT00442936|Drug|Placebo to zolmitriptan 5 mg|Placebo to match zolmitriptan 5 mg tablets
16327488|NCT00442533|Drug|Indium-111 pentetreotide|4 cycles of 500 mCi treatments every 10-12 weeks
16327489|NCT00442507|Drug|Erlotinib|
16327490|NCT00442507|Drug|Avastin|
16327411|NCT00442936|Drug|Rescue medication|If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.
16327412|NCT00442923|Drug|Coreg|
16327413|NCT00442910|Drug|3% SPL7013 Gel (VivaGel)|3% vaginal gel
16327414|NCT00442910|Drug|Placebo Gel|Placebo for SPL7013 gel
16327415|NCT00442910|Drug|HEC Placebo Gel|HEC Placebo gel intravaginally bd for 14 days
16327416|NCT00442897|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
16327417|NCT00442897|Drug|Comparator: atorvastatin|atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
16327418|NCT00442884|Behavioral|Trier Social Stress Test (TSST)|
16327419|NCT00442871|Drug|eltrombopag|eltrombopag 50 mg oral
16327420|NCT00020202|Drug|FR901228|
16327421|NCT00020046|Drug|docetaxel|
16327422|NCT00020046|Drug|thalidomide|
16327423|NCT00019968|Drug|melphalan|
16327424|NCT00019968|Drug|tumor necrosis factor|
16327425|NCT00019890|Drug|dendritic cell-gp100-MART-1 antigen vaccine|
16327426|NCT00019890|Drug|sargramostim|
16327427|NCT00019760|Drug|floxuridine|
16327428|NCT00019760|Drug|leucovorin calcium|
16327429|NCT00019760|Drug|melphalan|
16327430|NCT00019695|Drug|alendronate sodium|
16327431|NCT00019695|Drug|ketoconazole|
16327432|NCT00019630|Drug|doxorubicin HCl liposome|
16327433|NCT00019448|Drug|gp100 antigen|
16327434|NCT00019448|Drug|interleukin-2|
16327435|NCT00019396|Drug|flt3 ligand|
16327436|NCT00019396|Drug|gp100 antigen|
16327437|NCT00019396|Drug|MART-1 antigen|
16327438|NCT00019396|Drug|Montanide ISA-51|
16327439|NCT00019396|Drug|tyrosinase peptide|
16327440|NCT00019188|Drug|interleukin-12|
16327441|NCT00019097|Drug|autologous tumor cell vaccine|
16327442|NCT00019097|Drug|keyhole limpet hemocyanin|
16327443|NCT00019097|Drug|melphalan|
16327444|NCT00019097|Drug|sargramostim|
16327445|NCT00003552|Drug|allogeneic lymphocytes|
16327446|NCT00003552|Drug|anti-thymocyte globulin|
16327447|NCT00003552|Drug|cyclophosphamide|
16327448|NCT00003552|Drug|fludarabine|
16327449|NCT00442845|Drug|Atorvastatin (Lipitor)|
16327450|NCT00442832|Drug|TD-1792|TD-1792 2 mg/kg/day IV
16327451|NCT00442832|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs
16327452|NCT00442819|Procedure|Hemodialysis with Polymethylmethacrylate Artificial Kidney|
16327453|NCT00442806|Drug|Injection of ADRC's|ADRC's are injected
16327454|NCT00442806|Other|Injection of Placebo|Placebo is injected
16327455|NCT00442793|Drug|Epoetin beta|As prescribed, 3 times weekly
16327456|NCT00442793|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.4 micrograms/kg iv every 2 weeks
16327457|NCT00442780|Drug|BIIB014|oral administration of BIIB014 per dose, schedule,and duration specified in protocol
16327458|NCT00442780|Drug|Placebo|Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
16327459|NCT00442767|Drug|Insulin|Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.
16327460|NCT00442767|Drug|Pramlintide + Insulin|30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
16327461|NCT00442754|Biological|Allogeneic Tumour Lysate (MelCancerVac)|subcutaneaus, /once weekly /4 wks then /4 weekly
16327462|NCT00442741|Drug|Patupilone|
16327463|NCT00442741|Drug|Patupilone + Omeprazole|
16327464|NCT00442728|Device|ELECTRICAL STIMULATION|
16327465|NCT00442715|Procedure|Exercise chalenge test|
16327466|NCT00442702|Drug|Mircera|Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
16327467|NCT00442702|Drug|Darbepoetin alfa|As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
16327468|NCT00442689|Drug|flutamide|250 mg twice daily
16327469|NCT00442689|Drug|ethinyl estradiol 35 mcg and drospirenone 3 mg|one active pill per day for three weeks and then 1 sugar pill per day for one week
16327470|NCT00442689|Other|placebo|
16327471|NCT00442676|Drug|Celecoxib|Capsule, 200 mg/day until 32 weeks of gestation
16327472|NCT00442676|Drug|Placebo|Gelatin capsules of lactose
16327473|NCT00442663|Device|Transcervical Foley Catheter|
16327474|NCT00442663|Device|Transcervical Foley Catheter with an EASI|
16327475|NCT00442650|Drug|Efalizumab|
16327476|NCT00442637|Drug|capecitabine + bevacizumab|Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w
16327477|NCT00442637|Other|observation|observation after induction treatment
16327478|NCT00442611|Drug|Abatacept|
16327479|NCT00442611|Drug|Placebo|
16327480|NCT00442598|Drug|Glufosfamide|
16327481|NCT00442585|Drug|S(+)-ibuprofen|
16327482|NCT00442572|Drug|PEGASYS [peginterferon alfa-2a]|There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
16327483|NCT00442559|Drug|montelukast sodium|Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
16327484|NCT00442559|Drug|inhaled corticosteroid|Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
16327485|NCT00442546|Drug|pregabalin|150 milligram (mg)/ day (double blind)
16327486|NCT00442546|Drug|pregabalin|300 mg/day (double blind)
16327487|NCT00442546|Drug|Placebo|Placebo
16327661|NCT00441064|Drug|Aliskiren|
16327491|NCT00442494|Drug|intravenous hydrocortisone|
16327492|NCT00442481|Drug|Escitalopram|
16327493|NCT00442481|Procedure|A baseline overnight polysomnography (oPSG)|
16327494|NCT00442468|Other|Non-interventional study.|This is a non-interventional (no drug treatment administered), prevalence (observational) study.
16327495|NCT00442455|Drug|Erlotinib chlorhydrate|150 mg/day for 7 weeks
16327496|NCT00442455|Drug|Cisplatin|30 mg/m2 i.v. weekly for 7 weeks
16327497|NCT00442455|Procedure|Radiation therapy|63 Gy, five days a week, for 7 weeks
16327498|NCT00442442|Device|mosquito coils|mosquito coil / night mosquito coil & LLIN / night
16327499|NCT00442442|Device|LLIN|Sleep under LLIN every night
16327500|NCT00442416|Drug|Epoetin alfa|As prescribed, SC
16327501|NCT00442416|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120-360 micrograms SC monthly, starting dose
16327502|NCT00019578|Procedure|Sterotactic radiosurgery|
16327503|NCT00019006|Drug|Detox-B adjuvant|
16327504|NCT00019006|Drug|ras peptide cancer vaccine|
16327505|NCT00442403|Drug|chloroquine|
16327506|NCT00442403|Drug|dehydroepiandrosterone sulphate|
16327507|NCT00442390|Drug|hydrocortisone substitution therapy versus withdrawal|
16327508|NCT00442377|Procedure|exposure to malaria sporozoites|
16327509|NCT00442364|Drug|Polidocanol (1%) Microfoam (Varisolve)|Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.
16327510|NCT00442364|Procedure|Endovenous Microfoam Occlusion|Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
16327511|NCT00442351|Drug|Asmanex twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
16327512|NCT00442351|Other|Placebo for Asmanex twisthaler|Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
16327513|NCT00442338|Drug|montelukast sodium|Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
16327514|NCT00442338|Drug|montelukast sodium|Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
16327515|NCT00442338|Drug|aminophylline hydrate|Aminophylline 250 mg IV drip infusion over 60 minutes
16327516|NCT00442325|Drug|Atorvastatin (Lipitor)|
16327517|NCT00442312|Drug|Combigan Ophthalmic Solutiom|
16327518|NCT00442299|Device|Fractionated Plasma Separation and Adsorption (FPSA)|
16327519|NCT00442286|Device|Rheos® Baroreflex Hypertension System|Electrical activation of the Carotid Baroreflex
16327520|NCT00442273|Drug|Umbilical cord serum eyedrops|
16327521|NCT00442273|Drug|Autologous serum eyedrops|
16327522|NCT00442260|Drug|DOXIL|
16327523|NCT00442260|Drug|Abraxane|
16327524|NCT00442247|Device|Pelvicol|
16327525|NCT00442234|Drug|Monteplase|
16327526|NCT00442221|Drug|Sumatriptan and Naproxen sodium|
16327527|NCT00442208|Drug|PN 200|
16327528|NCT00442182|Drug|ITF2357|
16327529|NCT00442169|Biological|ChimeriVax-WN02 Low Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.
16327530|NCT00442169|Biological|ChimeriVax-WN02 Medium Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
16327531|NCT00442169|Biological|ChimeriVax-WN02 High Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
16327532|NCT00442169|Biological|0.9% Saline solution|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
16327533|NCT00442169|Biological|ChimeriVax-WN02 High Dose|Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
16327534|NCT00442169|Biological|0.9 % NaCl solution|Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
16327535|NCT00442156|Procedure|Laser photocoagulation|modified ETDRS focal photocoagulation generally completed in a single sitting on the day of enrollment, but if little or no improvement, may be repeated at 16 weeks
16327536|NCT00442143|Procedure|Stem cell implantation|
16327537|NCT00442130|Biological|GM-K562 vaccine|The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.
16327538|NCT00442130|Procedure|stem cell transplantation|Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation
16327539|NCT00442117|Drug|mometasone furoate dry powder inhaler|MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
16327540|NCT00442117|Drug|Budesonide DPI|Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.
16327541|NCT00442104|Drug|Ganaxolone|
16327542|NCT00442091|Drug|dandelion juice|10 ml bid for 20-30 days
16327543|NCT00442078|Device|I-STOP TOMS male sling|Bulbus urethral compression with polypropylene mesh
16327544|NCT00442065|Device|Aorfix™ Stent Grafts (AAA endovascular procedure)|Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System
16327545|NCT00442052|Drug|aspirin|
16327546|NCT00442052|Drug|omeprazole|
16327547|NCT00442039|Drug|Lithium Carbonate|The starting dose of lithium was 300 mg for patients weighing < 20 kg
16327548|NCT00442039|Drug|Lithium Carbonate|"The dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability. The starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability"
16327549|NCT00442039|Drug|Lithium Carbonate|"The starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patients response and tolerability."
16327550|NCT00442039|Drug|Placebo|During the third phase, which is the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks.
16327551|NCT00442026|Drug|Docetaxel|Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
16327552|NCT00442026|Drug|Gemcitabine|Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
16327553|NCT00442026|Drug|Gemcitabine|Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
16327554|NCT00442013|Drug|Lansoprazole|Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.
16327555|NCT00442013|Drug|Matching placebo|Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
16327556|NCT00442000|Procedure|Prostatectomy|Patients undergoing prostatectomy.
16327557|NCT00441987|Drug|GSI-953|
16327558|NCT00441974|Drug|adefovir dipivoxil|adefovir dipivoxil once daily one tablet 10mg orally
16327559|NCT00441961|Drug|methotrexate|methotrexate
16327560|NCT00441948|Device|Peterio|
16327561|NCT00441935|Device|Interstim Neuromodulation|Two stage procedure to implant an interstim device for neuromodulation.
16327562|NCT00441922|Drug|Docetaxel|Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
16327563|NCT00441922|Drug|Vinorelbine|Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
16327564|NCT00441909|Drug|UC-781|0.1% UC-781 Vaginal Gel
16327565|NCT00441909|Drug|UC-781 placebo|Vaginal Gel Placebo
16327566|NCT00441896|Drug|Ganaxolone|
16327567|NCT00441896|Other|Placebo|
16327568|NCT00441883|Drug|PF-03187207 and Latanoprost Vehicle|
16327569|NCT00441883|Drug|Latanoprost 0.005% and PF-03187207 Vehicle|
16327570|NCT00441870|Drug|EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)|Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
16327571|NCT00441870|Drug|99mTC-EC20 (Folic acid-technetium 99m conjugate)|20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
16327572|NCT00441857|Behavioral|plant stanol consumption|
16327573|NCT00441844|Drug|Simvastatin|
16327574|NCT00441818|Drug|TNX-650|
16327575|NCT00441805|Device|Radio Frequency|
16327576|NCT00441792|Drug|Etomidate|Etomidate at induction dose based on weight
16327577|NCT00441792|Drug|midazolam|Midazolam at induction dose based on weight
16327578|NCT00441766|Drug|AGN 203818|Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks
16327579|NCT00441766|Drug|AGN 203818|Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks
16327580|NCT00441766|Drug|AGN 203818|Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks
16327581|NCT00441766|Drug|placebo|Part A: placebo capsule every 12 hours for 4 weeks
16327582|NCT00441740|Drug|Vinorelbine|Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
16327583|NCT00441740|Drug|Gemcitabine|Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
16327584|NCT00441740|Drug|Docetaxel|Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
16327585|NCT00441740|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
16327586|NCT00441727|Drug|Esomeprazole 40 mg|Esomeprazole 40 mg once daily
16327587|NCT00441727|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg once daily
16327588|NCT00441727|Drug|Placebo|Placebo once daily
16327589|NCT00441714|Procedure|repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise|
16327590|NCT00441701|Drug|Navarixin 1 mg|Navarixin 1 mg capsules
16327591|NCT00441701|Drug|Navarixin 10 mg|Navarixin 10 mg capsules
16327592|NCT00441701|Drug|Placebo to match navarixin|Placebo to navarixin capsules
16327593|NCT00441701|Drug|Rescue medication|Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief
16327594|NCT00441688|Drug|GI265235|
16327595|NCT00441675|Procedure|Symptom Score|Symptom Score
16327596|NCT00441675|Procedure|Symptom Score and PD20|Symptom Score and PD20
16327597|NCT00441662|Drug|Sub-Tenon triamcinolone 40mg|
16327598|NCT00441649|Drug|Methylphenidate|
16327599|NCT00441636|Device|continuous positive airway pressure (CPAP)|CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist
16327600|NCT00441623|Behavioral|observational|effect of protein-bound uremic retention solutes
16327601|NCT00441610|Drug|Gimatecan|
16327602|NCT00441597|Drug|atorvastatin|atorvastatine 80mg, during 3 days
16327603|NCT00441584|Biological|PegIntron (peginterferon alfa-2b)|Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
16327604|NCT00441584|Drug|Rebetol (ribavirin)|200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks
16327605|NCT00441571|Drug|177Lu-CYT-500|
16327606|NCT00441558|Drug|Flibanserin|flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
16327607|NCT00441545|Drug|Fosrenol (Lanthanum Carbonate)|The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
16327608|NCT00441545|Drug|Sevelamer hydrochloride|The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
16327609|NCT00441532|Drug|Lidocaine|
16327610|NCT00441519|Drug|aspirin|
16327611|NCT00441519|Drug|omeprazole|
16327612|NCT00441506|Drug|daily interruption of sedatives|
16327613|NCT00441493|Drug|fluvastatin|
16327614|NCT00441480|Dietary Supplement|Plant sterols esters|1.6g phytosterols and 1.3g omega-3 fatty acids per day
16327615|NCT00441480|Dietary Supplement|placebo|4 gr of corn oil
16327616|NCT00441467|Drug|Glufosfamide|5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
16327617|NCT00441454|Device|Transobturator Tension-free vaginal tape (TVT-O)|tension-free vaginal tape (TVT)
16327618|NCT00441454|Device|Retropubic Tension-free vaginal tape (TVT)|Retropubic Tension-free vaginal tape (TVT)
16327619|NCT00441441|Drug|fluticasone propionate|fluticasone propionate 100mcg HFA
16327620|NCT00441441|Drug|fluticasone propionate/salmeterol|fluticasone propionate/salmeterol 100/50mcg HFA
16327621|NCT00441428|Drug|solifenacin|
16327622|NCT00441415|Drug|Adapalene BPO|
16327623|NCT00441376|Drug|ThermoDox|15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.
16327624|NCT00441363|Drug|Bromocriptine Mesylate|0.8 mg tablet
16327625|NCT00441350|Drug|OM 40|Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
16327626|NCT00441350|Drug|OM/HCTZ 40/12.5|Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
16327627|NCT00441337|Biological|MDX-1106|patients will receive a single dose of MDX-1106 as a 60 minute infusion.
16327628|NCT00441324|Procedure|recombinant human LH|
16327629|NCT00441311|Behavioral|Academic Detailing|The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also be customized to each physician, although the frequency of the detailing visits will be routinized across all participants to reduce cost and to maximize its potential for dissemination.
16327630|NCT00441298|Drug|Tenofovir gel|Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
16327631|NCT00441298|Drug|Placebo (Universal HEC placebo)|Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
16327632|NCT00441285|Drug|Praziquantel|- Praziquantel 50 mg / kg / d (up to 3600 mg / d ) for 10 days.
16327633|NCT00441285|Drug|Albendazole|"Albendazole 15 mg / kg / d ( up to 800 mg /d ) in Arm I for 10 days.
~Albendazole at an increased dose, 22.5 mg / kg / d (up to 1200 mg / d ), in Arm II for 10 days."
16327634|NCT00441285|Drug|ABZ Placebo|- Placebo (of Albendazole ) 7.5 mg / kg / d in Arm I and II for 10 days.
16327635|NCT00441285|Drug|PZQ Placebo|- Placebo (of Praziquantel) 50 mg / kg / d in Arm II and III for 10 days.
16327636|NCT00441272|Drug|Pioglitazone|
16327637|NCT00441259|Biological|ChimeriVax™-JE|One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously
16327638|NCT00441259|Biological|Japanese Encephalitis Inactivated Mouse Brain Vaccine|Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously
16327639|NCT00441246|Drug|Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)|
16327640|NCT00441233|Device|Silicone hydrogel contact lens|
16327641|NCT00441207|Drug|Ascorbic Acid|Delivered via IV Infusion.
16327642|NCT00441194|Device|Visual Field (Octopus 311 and the HFA 700 series)|
16327643|NCT00441181|Drug|Travoprost|
16327644|NCT00441168|Drug|adriamycin|adriamycin: 9mg/m² intravenous (IV) push on days 1 to 4
16327645|NCT00441168|Drug|bortezomib|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11
16327646|NCT00441168|Drug|dexamethasone|dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
16327647|NCT00441168|Drug|vincristine|vincristine: 0.4mg IV push on days 1 to 4
16327648|NCT00441155|Drug|Nilotinib, Imatinib|Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.
16327649|NCT00441142|Drug|ZD6474|Taken orally once a day (at 100 mg/day is the phase II dose; the MTD determined by the phase I portion of the trial) until disease gets worse or participants experience unacceptable side effects
16327650|NCT00441142|Drug|temozolomide|"During the 'Induction' phase: 75/mg/m2/day temozolomide will be given orally daily for 6 weeks (42 days) during radiation therapy, beginning either the night before or on the first day of the first fraction of radiation, including weekends and holidays. This is followed by a 4-6 week break.
~During the 'Maintenance' phase: The first post-radiation temozolomide cycle will be administered at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle. If 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given. This is given for 12 cycles."
16327651|NCT00441142|Radiation|Radiation Therapy|Radiotherapy must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy.
16327652|NCT00441129|Device|Minimed paradigm Real Time Sytem|Minimed paradigm Real Time Sytem
16327653|NCT00441129|Device|Minimed Paradigm 512/712 Insulin pump|Minimed Paradigm 512/712 Insulin pump
16327654|NCT00441116|Drug|Dutasteride 0.5mg oral tablets|Dutasteride
16327655|NCT00441103|Drug|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.
16327656|NCT00441103|Drug|Placebo|Matching placebo will be administered subcutaneously three times a week for 16 weeks.
16327657|NCT00441103|Drug|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.
16327658|NCT00441090|Drug|Placebo|Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
16327659|NCT00441090|Drug|Avatrombopag tablets|Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.
16327660|NCT00441077|Behavioral|Education|
16327662|NCT00441051|Drug|Diclofenac sodium 1mg/g|
16327663|NCT00441038|Behavioral|The Back Guide|Education on postural hygiene and handout of The Back Guide
16327664|NCT00441038|Behavioral|The Back Book|Education on active management and Handout of The Back Book
16327665|NCT00441038|Behavioral|Cardiovascular and general health|Education on cardiovascular and general health
16327666|NCT00441025|Drug|Alemtuzumab|
16327667|NCT00441012|Biological|Comparator: Modified Process Vaccine|Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.
16327668|NCT00441012|Biological|Comparator: COMVAX™|COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
16327669|NCT00440999|Drug|Pyronaridine artesunate|
16327670|NCT00440999|Drug|Chloroquine|
16327671|NCT00440986|Procedure|Eritrocytoapheresis|
16327672|NCT00440973|Drug|Bevacizumab|monoclonal antibody with anti-angiogenesis properties used as chemotherapy
16327673|NCT00440973|Drug|Interleukin-2|immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T & B lymphocyte proliferation
16327674|NCT00440960|Drug|propofol|
16327675|NCT00440960|Drug|midazolam|
16327676|NCT00440960|Drug|alfentanil|
16327677|NCT00440960|Drug|lidocaine|
16327678|NCT00440947|Drug|Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)|Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen
16327679|NCT00440947|Drug|Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)|Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen
16327680|NCT00440934|Device|Amplitude-modulated electromagnetic fields|
16327681|NCT00440921|Drug|Single donor Allogenous Fibrin Sealant|
16327682|NCT00440895|Drug|Abciximab|Abciximab (bolus) i.c. or i.v. or placebo, bolus dose is calculated according to current dosage (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
16327683|NCT00440869|Dietary Supplement|N-acetylcysteine|600 mg po bid
16327684|NCT00440869|Dietary Supplement|placebo|bid oral dosing
16327685|NCT00440856|Behavioral|Presentation of excised intervertebral disc fragments|
16327686|NCT00440843|Drug|Olanzapine (Zyprexa)|OLZ
16327687|NCT00440843|Drug|Typicals|Stay on typicals regimen
16327692|NCT00440817|Other|No intervention|All treatments are prescribed by a physician on the basis of usual clinical practice.
16327693|NCT00440804|Drug|ibuprofen l-lysine iv solution (NeoProfen (R) )|
16327694|NCT00440791|Device|PillCam Colon capsule endoscopy|
16327695|NCT00440778|Drug|Abciximab|100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
16327696|NCT00440765|Drug|bortezomib|dose as determined (observational study) by treating physician
16327697|NCT00440739|Drug|etoricoxib|etoricoxib 120 mg
16327698|NCT00440739|Drug|flavoxate|flavoxate 200 mg 3 times
16327699|NCT00440739|Drug|etoricoxib, flavoxate|etoricoxib 120 mg once and flavoxate 200 mg 3 times
16327700|NCT00440739|Drug|placebo|placebo once and placebo 3 times
16327701|NCT00440726|Drug|Bortezomib|Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.
16327702|NCT00440726|Drug|Dexamethasone|10 mg/m2/day divided BID, oral administration for 14 days.
16327703|NCT00440726|Drug|PEG-asparaginase|2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22
16327704|NCT00440726|Drug|Doxorubicin|60 mg/m2/day IV over 15 minutes on Day 1
16327705|NCT00440726|Drug|Cytarabine|"Given intrathecally on Day 1 of course 1 at the dose defined by age below.
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age"
16327706|NCT00440726|Drug|Methotrexate|"Given intrathecally to all patients who are CNS 1 at study entry on Day 15 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
16327707|NCT00440726|Drug|Vincristine|1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.
16327708|NCT00440726|Drug|Triple IT Therapy|"Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:
~Methotrexate-
~<2 years: 8 mg
~2 - <3 y: 10 mg
~3 - <9 y: 12 mg
~>=9 y: 15 mg
~Cytarabine:
~<2 years: 16 mg
~2 - <3 y: 20 mg
~3 - <9 y: 24 mg
~>=9 y: 30 mg
~Hydrocortisone:
~<2 years: 8 mg
~2 - <3 y: 10 mg
~3 - <9 y: 12 mg
~>=9 y: 15 mg"
16327709|NCT00440713|Drug|Aripiprazole|
16327710|NCT00440713|Behavioral|Interpersonal Therapy|
16327711|NCT00440700|Behavioral|Anxiety Self-Management, Patient preferred relaxing music|Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
16327712|NCT00440700|Behavioral|Control 1: Noise-cancelling headphones|Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
16327713|NCT00440700|Behavioral|Control 2: Standard of Care|Usual ICU nursing care.
16327714|NCT00440687|Drug|Fluticasone 500mcg BD via accuhaler or identical placebo|
16327715|NCT00440674|Device|CoStar Paclitaxel-eluting coronary stent system|
16327716|NCT00440661|Drug|Diacerhein|
16327717|NCT00440648|Drug|sevelamer carbonate, sevelamer hydrochloride|Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
16327718|NCT00440648|Drug|sevelamer hydrochloride, sevelamer carbonate|Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
16327719|NCT00440635|Drug|Bortezomib, tradename Velcade|
16327720|NCT00440622|Drug|Gemcitabine|Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
16327721|NCT00440622|Drug|Herceptin|Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV
16327722|NCT00440622|Drug|Capecitabine (Xeloda)|Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
16327723|NCT00440609|Drug|ranibizumab|0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.
16327724|NCT00440596|Behavioral|Mindfulness based stress reduction|8 weeks group MBSR
16327725|NCT00440596|Behavioral|Progressive Muscle Relaxation|8 weeks PMR in group format
16327726|NCT00440583|Drug|chemotherapy followed by Zevalin|6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin
16327727|NCT00440570|Device|Low levels of amplitude-modulated electromagnetic fields|
16327728|NCT00440570|Device|Emitter of low levels of amplitude-modulated electromagnetic fields|
16327729|NCT00440557|Drug|Epoetin alfa 3 times weekly /once weekly|Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)
16327730|NCT00440557|Drug|Epoetin alfa once weekly|Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).
16327731|NCT00440557|Drug|Epoetin alfa once every two weeks|Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).
16327732|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen in BCG naive subjects
16327733|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
16327734|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|50 ug H1 antigen in BCG immunized subjects
16327735|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
16327736|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen in BCG immunized subjects
16327737|NCT00440544|Biological|Ag85B-ESAT6 fusion protein H1|100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
16327738|NCT00440531|Biological|Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)|RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
16327739|NCT00440531|Biological|Comparator: Modified Process Hepatitis B Vaccine (Experimental)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
16327740|NCT00440531|Biological|Comparator: ENGERIX-B™ (currently licensed product)|ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.
16327741|NCT00440518|Drug|Lacosamide|Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
16327742|NCT00440518|Other|Placebo|Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
16327743|NCT00440518|Drug|Lacosamide|Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
16327744|NCT00440505|Drug|Placebo|Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
16327745|NCT00440505|Drug|Nicotine (5 mg)|Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
16327746|NCT00440505|Drug|Nicotine (10 mg)|Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
16327747|NCT00440492|Drug|PLA-695|
16327748|NCT00440479|Drug|Bortezomib|dose as determined (observational study) by treating physician
16327749|NCT00440466|Drug|epoetin alfa|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
16327750|NCT00440466|Drug|epoetin alfa|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
16327751|NCT00440466|Drug|epoetin alfa|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
16327752|NCT00440453|Other|Nutritional therapy|Nutritional therapy by dietician
16327753|NCT00440440|Drug|Testosterone gel|Testosterone gel to be applied daily, starting does 5g.
16327754|NCT00440440|Drug|placebo|placebo gel apply daily
16327755|NCT00440427|Drug|Desvenlafaxine Sustained Release (DVS SR)|
16327756|NCT00440414|Drug|Erlotinib (Tarceva)|Erlotinib at the dose of 150 mg orally once a day continually until progression
16327757|NCT00440414|Drug|Pemetrexed (Alimta)|Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
16327758|NCT00440401|Drug|fibrinogen (human) + thrombin (human)|
16327759|NCT00440401|Drug|Standard haemostatic treatment in cardiovascular surgery|Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)
16327760|NCT00440388|Drug|AT-101|AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
16327761|NCT00440388|Drug|Rituximab|Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.
16327762|NCT00440375|Drug|Rosiglitazone|
16327763|NCT00440362|Biological|AVX502|1 dose at 2e8 IU given at t=0 via IM route
16327764|NCT00440362|Biological|AVX502|1 dose at 2e7 IU given at T=0 via the IM route
16327765|NCT00440362|Biological|AVX502|1 dose at 2e7 IU given at t=0 via the SC route
16327766|NCT00440362|Biological|AVX502|1 dose at 2e8 IU given at T=0 via the SC route
16328086|NCT00438321|Drug|Anastrozole Pill|
16327767|NCT00440362|Biological|AVX502|2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route
16327768|NCT00440362|Biological|AVX502|2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route
16327769|NCT00440362|Biological|AVX502|2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route
16327770|NCT00440362|Biological|AVX502|2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route
16327771|NCT00440362|Biological|Placebo|1 dose of placebo given at T=0 via the IM route
16327772|NCT00440362|Biological|Placebo|1 dose of placebo given at T=0 via the SC route
16327773|NCT00440362|Biological|Placebo|2 doses of placebo given at T=0 and 8 weeks via the IM route
16327774|NCT00440362|Biological|Placebo|2 doses of placebo given at T=0 and 8 weeks via the SC route
16327775|NCT00440349|Drug|Tamoxifen|
16327776|NCT00440349|Drug|Prednisone|
16327777|NCT00440336|Drug|Cosopt|
16327778|NCT00440336|Drug|Xalatan|
16327779|NCT00440323|Drug|SB-649868|SB-649868 tablets will be available with dose strength of 5 and 25 mg.
16327780|NCT00440323|Drug|Zolpidem|Zolpidem capsules will be available with dose strength of 10 mg.
16327781|NCT00440323|Drug|Placebo|Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
16327782|NCT00440310|Drug|Talaporfin sodium|LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
16327783|NCT00440310|Procedure|Percutaneous placement of device in liver metastases|Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
16327784|NCT00440310|Device|Interstitial light emitting diodes|200 J/cm per Light Source at 20 mW/cm light energy
16327785|NCT00440310|Drug|FOLFOX4 regimen|Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
16327786|NCT00440310|Drug|FOLFIRI regimen|Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
16327787|NCT00440297|Biological|Comparator: modified process hepatitis B vaccine|Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
16327788|NCT00440297|Biological|Comparator: ENGERIX-B™|ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
16327789|NCT00440284|Drug|conventional vs. flexible, intensive insulin therapy|
16327790|NCT00440271|Drug|tipranavir|
16327791|NCT00440271|Drug|ritonavir|
16327792|NCT00440271|Drug|Optimized Background Regimen (OBR)|Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.
16327793|NCT00440258|Drug|Cabergoline|
16327794|NCT00440258|Procedure|MR|
16327795|NCT00440258|Procedure|Ultrasound|
16327796|NCT00440258|Procedure|Blood Analysis|
16327797|NCT00440245|Drug|salbutamol|200 micrograms salbutamol from MDI
16327798|NCT00440232|Drug|Frovatriptan|Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
16327799|NCT00440232|Drug|Placebo|Inert tab identical in appearance to Frovatriptan
16327800|NCT00440219|Drug|Oral Prednisone|Prednisone 50 mg once daily for 10 days pre-op
16327801|NCT00440219|Drug|Placebo comparator|Placebo pill identical to Prednisone 10 days once daily pre-op
16327802|NCT00440193|Drug|Rivaroxaban (Xarelto, BAY59-7939)|During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
16327803|NCT00440193|Drug|Enoxaparin followed by VKA|Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
16327804|NCT00440180|Drug|Anastrozole|1 mg qd for 4 months
16327805|NCT00440180|Drug|Placebo|Placebo Comparator
16327806|NCT00440167|Drug|Gemcitabine|Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
16327807|NCT00440167|Drug|Capecitabine|"Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause (Flat Dosing)"
16327808|NCT00440167|Drug|Erlotinib|Erlotinib 150 mg/d oral, daily without break
16327809|NCT00440154|Drug|AVE5530|
16327810|NCT00440154|Drug|placebo|
16327811|NCT00440154|Drug|ezetimibe|
16327812|NCT00440141|Drug|latanoprost 0.005% eye drops and brimonidine 0.1% eye drops|latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
16327813|NCT00440141|Drug|latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops|latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
16327814|NCT00440128|Drug|Docetaxel|Docetaxel
16327815|NCT00440128|Drug|Casopitant/Docetaxel|Casopitant/Docetaxel
16327816|NCT00440115|Behavioral|High intensity disease management|Health education mailings, 6 motivation interviews/counseling
16327817|NCT00440115|Behavioral|Low intensity disease management|Health education mailings, one motivation interview/counseling
16327818|NCT00440115|Behavioral|Comparison group|Health education mailings
16327819|NCT00440115|Drug|Bupropion|Buproprion or Nicotine Replacement Therapy
16327820|NCT00440102|Drug|Ketamine|Ketamine
16327821|NCT00440102|Drug|Etomidate|Etomidate
16327822|NCT00440089|Behavioral|Hands-on-Healing|
16327823|NCT00440076|Drug|Velcade|
16327824|NCT00440063|Drug|epoetin beta [NeoRecormon]|
16327825|NCT00440050|Drug|DHA (Docosahexaenoic Acid)|950 mg soft-gel capsules which contain approximately 510 mg DHA, 2 capsules twice a day for 18 months
16327826|NCT00440050|Drug|Placebo|2 placebo capsules twice a day for 18 months
16327827|NCT00440037|Biological|AMG 531|AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.
16327828|NCT00440024|Drug|Tazorac|Tazarotene 0.1% cream applied to the face once daily before bed
16327829|NCT00440024|Drug|Dove Mild Cleanser|Ultra mild cleanser: Dove Non-foaming cleansing lotion
16327830|NCT00440024|Drug|Dove Facial Moisturizer|Moisturizing cream - Dove facial moisturizer with SPF 15
16327831|NCT00440011|Drug|bimatoprost 0.03% eye drops|bimatoprost 0.03% 1 drop nightly for 3 months
16327832|NCT00440011|Drug|travoprost 0.004% eye drops|travoprost 0.004% 1 drop nightly for 3 months
16327833|NCT00439998|Procedure|Ultrasound|ultrasound scan of the lumbar spine with 2-5 MHz curved array probe
16327834|NCT00439985|Behavioral|Cognitive Behavioral Therapy|The treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work).
16327835|NCT00439972|Drug|Ortho-Cyclen (R)|The first 21 tablets contain 35 micrograms ethinyl-estradiol and 250 micrograms norgestimate per tablet. The last 7 tablets contain no hormones. Ortho Cyclen (R) is taken for 1-2 months during the screening phase and for 2 months during the treatment phase of the study.
16327836|NCT00439972|Drug|Ortho Evra (R)|Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule is to apply one patch each week for 3 weeks and no patch the 4th week. Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
16327837|NCT00439972|Drug|extended use of Ortho Evra (R)|The extended use regimen of Ortho Evra (R) contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch. The dosing schedule for Ortho-Evra (R) is to apply one patch each week for 7 weeks and no patch the 8th week. Extended use Ortho Evra (R) is taken for 2 months during the treatment phase of the study.
16327838|NCT00439959|Drug|GSK625433/placebo|
16327839|NCT00439946|Drug|treprostinil|rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
16327840|NCT00439946|Device|Crono Five ambulatory pump|Used for administration of IV Remodulin (treprostinil)
16327841|NCT00439933|Behavioral|low fat and polysaccharide rich diet|
16327842|NCT00439933|Behavioral|specific physical training program for obese children|
16327843|NCT00439920|Drug|High-dose anthracycline|
16327844|NCT00439907|Procedure|End-to-end repair of the external anal sphincter muscle|Surgical procedure: End-to-end repair of the external anal sphincter muscle
16327845|NCT00439907|Procedure|Overlap repair of the external anal sphincter muscle|Surgical procedure: Overlap repair of the external anal sphincter muscle
16327846|NCT00439894|Procedure|Blood draw|blood draw at baseline, week 12 and week 24
16327847|NCT00439881|Drug|SB-681323|
16327848|NCT00439868|Drug|WellbutrinXL|WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
16327849|NCT00439868|Drug|placebo|Matching placebo tablets to WELLBUTRIN XL.
16327850|NCT00439855|Drug|Enoxaparin i.v.|
16327851|NCT00439855|Drug|unfractionated heparin|
16327852|NCT00439842|Behavioral|Heart Failure Group Clinic Appointments|Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
16327853|NCT00439829|Drug|Gonal F|"450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork).
~Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below).
~Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS."
16327854|NCT00439829|Drug|Luveris|"0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:
~leading follicle is > 13 mm in diameter
~if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
~Dosing to continue until administration of hCG (see below)."
16327855|NCT00439829|Drug|Cetrotide|"0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:
~leading follicle is > 13 mm in diameter
~if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
~Dosing to continue until administration of hCG (see below)."
16327856|NCT00439829|Drug|hCG|"- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when:
~o > 3 follicles are > 17 mm in diameter"
16327857|NCT00439816|Behavioral|Group Visits|
16327858|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
16327859|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the IM route
16327860|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
16327861|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the SC route
16327862|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
16327863|NCT00439803|Biological|AVX601|3 doses of placebo given at T=0, 8, 24 weeks via the IM route
16327864|NCT00439803|Biological|AVX601|3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
16327865|NCT00439803|Biological|Placebo|3 doses of placebo given at T=0, 8, 24 weeks via the SC route
16327866|NCT00439790|Procedure|Microneurography|Microneurography
16327867|NCT00439777|Drug|Rivaroxaban (Xarelto, BAY59-7939)|During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
16327868|NCT00439777|Drug|Enoxaparin overlapping with and followed by VKA|Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
16327869|NCT00439764|Behavioral|General health talk|Routine clinical practice and talk on general health
16327870|NCT00439764|Behavioral|Handout of The Back Book|Talk on health of the back and handout of The Back Book
16327871|NCT00439764|Behavioral|Back exercise|Routine clinical practice, talk on back health, handout of The Back Book and back exercise
16327872|NCT00439751|Drug|Goserelin Acetate|Continuous goserelin, 12 week (10.8 mg) depot, will be used as ADT for both study arms. It is supplied as a sterile syringe for subcutaneous use.
16327873|NCT00439738|Drug|HCTZ + Amlodipine|"12.5 mg HCTZ capsules
~25 mg HCTZ capsules
~5 mg amlodipine capsules
~10 mg amlodipine capsules"
16327874|NCT00439738|Drug|Valsartan/HCTZ|"160 mg film-coated valsartan tablets
~320 mg film-coated valsartan tablets
~12.5 mg HCTZ capsules
~25 mg HCTZ capsules"
16327875|NCT00439725|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
16327876|NCT00439725|Drug|Placebo|Patients allocated to placebo will receive a matching placebo tablet once daily.
16327877|NCT00439712|Drug|Levocetirizine|1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days
16327878|NCT00439712|Drug|Placebo|1 placebo tablet OD in the morning for 29+/-4 days
16327879|NCT00439699|Drug|Memantine|Mematine administration
16327880|NCT00439686|Drug|ZIO-201|ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months
16327881|NCT00439673|Drug|5-Azacytidine|
16327882|NCT00439673|Drug|Valproic Acid|
16327883|NCT00439673|Drug|ATRA|
16327884|NCT00439660|Biological|Oral Rotavirus Vaccine 116E Live Attenuated|
16327885|NCT00439647|Drug|Zoledronic acid 5 mg iv|Zoledronic acid 5 mg iv given once a year.
16327886|NCT00439647|Drug|Placebo|Placebo intravenous (i.v.) once a year
16327887|NCT00439634|Drug|AVE1625|oral administration
16327888|NCT00439634|Drug|placebo|oral administration
16327889|NCT00439621|Biological|RP 01|Active immunotherapy
16327890|NCT00439608|Drug|Cetuximab,Paclitaxel, Carboplatin|IV treatment for 6 weeks
16327891|NCT00439595|Device|Hemocue 210 meter|Diagnostic device
16327892|NCT00439595|Device|Copack HBCS|
16327893|NCT00439582|Dietary Supplement|vaccenic acid enriched milk fat (VAMF) [Transfact1]|
16327894|NCT00439582|Dietary Supplement|hydrogenated oil|Partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats
16327895|NCT00439569|Drug|sodium phenylbutyrate|500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD
16327896|NCT00439556|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
16327897|NCT00439556|Biological|Anti-Thymocyte Globulin|Given IV
16327898|NCT00439556|Drug|Bortezomib|Given IV
16327899|NCT00439556|Drug|Carmustine|Given IV
16327900|NCT00439556|Drug|Cytarabine|Given IV
16327901|NCT00439556|Drug|Etoposide|Given IV
16327902|NCT00439556|Biological|Filgrastim|Given SC
16327903|NCT00439556|Drug|Melphalan|Given IV
16327904|NCT00439556|Drug|Methotrexate|Given IV
16327905|NCT00439556|Biological|Rituximab|Given IV
16327906|NCT00439556|Drug|Tacrolimus|Given IV and PO
16327907|NCT00439543|Drug|Iloprost inhalation|
16327908|NCT00439530|Drug|oseltamivir|
16327909|NCT00439530|Drug|probenecid|
16327910|NCT00439517|Drug|UFOX + Cetuximab|"Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)
~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
16327911|NCT00439517|Drug|FOLFOX4 + Cetuximab|"Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)
~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)
~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16
~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
16327912|NCT00439504|Drug|Lobeline|
16327913|NCT00439491|Behavioral|Hypocaloric diet|
16327914|NCT00439478|Drug|Radioiodine|
16327915|NCT00439465|Biological|Ex-vivo expanded effector cells|This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
16327916|NCT00439452|Other|Telemedicine-Based Collaborative Care|Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers. Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response. Telephone pharmacist activities include documenting medication histories and conducting medication management. Tele-psychologist activities include providing cognitive behavioral therapy via interactive video. Tele-psychiatrist activities include conducting patient consultation via interactive video.
16327917|NCT00439452|Other|Practice Based Collaborative Care|One-site nurse care manager works collaboratively with on-site primary care providers. Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
16327918|NCT00439439|Radiation|Beamer Ablation (Argon Plasma Coagulation)|APC-Beamerablation of heterotopic gastric mucosa
16327919|NCT00439426|Drug|Oxaliplatin|130mg/m2 iv on day 1 of each 3 week cycle
16327920|NCT00439426|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-14 of each 3 week cycle
16327921|NCT00439413|Drug|Selegiline Transdermal Patch|Selegiline cm(2) via transdermal system
16327922|NCT00439413|Drug|Placebo|Matching placebo via transdermal system
16327923|NCT00439413|Behavioral|Smoking Cessation Counseling|Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
16327924|NCT00439400|Drug|doxycycline|
16327925|NCT00439400|Drug|placebo|
16327926|NCT00439374|Drug|17 alpha-hydroxyprogesterone caproate|Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
16327927|NCT00439374|Other|Placebo Oil|Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
16327928|NCT00439361|Drug|Bortezomib|1.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4
16328087|NCT00438321|Other|Placebo|
16327929|NCT00439361|Drug|Carboplatin|5 AUC by Vein Over 1 Hour On Day 1
16327930|NCT00439361|Drug|Etoposide|100 mg/m^2 By Vein Over 2 Hours On Days 1-3
16327931|NCT00439361|Drug|Ifosfamide|5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1
16327932|NCT00439361|Drug|Mesna|5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion
16327933|NCT00439348|Behavioral|Verbal advice|Patients receive verbal advice regarding specific over-the-counter medications.
16327934|NCT00439348|Behavioral|Prescription|Patients receive a prescription for a specific over-the-counter medication.
16327935|NCT00439335|Biological|Inactivated Influenza A Vaccine A/H5N1|Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection. Vaccine will be administered to each subject at Days 0 and 28.
16327936|NCT00439335|Biological|Inactivated Influenza A Vaccine A/H5N1|Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection. Vaccine will be administered to each subject at Days 0 and 28.
16327937|NCT00439335|Drug|Placebo (IM)|The placebo will be 0.1 mL of saline administered by the IM route.
16327938|NCT00439335|Drug|Placebo (ID)|The placebo will be 0.1 mL of saline administered by the ID route.
16327939|NCT00439309|Device|Gelfoam/Thrombin|Gelfoam/Thrombin
16327940|NCT00439309|Device|VascuSeal|VascuSeal
16327941|NCT00439296|Drug|ABT-751|"Treatment Course 1:
~Oral capsule to be given daily for 21 days at assigned dose.
~Treatment Course 2:
~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.
~Treatment Course 3:
~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest."
16327942|NCT00439296|Drug|Dexamethasone|"In Treatment Course 1 only:
~10 mg/m2/day divided BID.
~Take dexamethasone by mouth days 1-14."
16327943|NCT00439296|Drug|PEG-asparaginase|"In Treatment Course 1:
~2500 IU's/m2/day.
~Intramuscular injection (IM) on days 4, 11 and 18.
~In Treatment Course 2:
~2500 IU's/m2/day.
~Intramuscular injection (IM) on day 15."
16327944|NCT00439296|Drug|Doxorubicin|"In Treatment Course 1 only:
~• 60 mg/m2/day IV over 15 minutes on day 1."
16327945|NCT00439296|Drug|Cytarabine|"Given Intrathecally on day 1 of course 1 at the dose defined by age below.
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age
~Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.
~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12."
16327946|NCT00439296|Drug|Methotrexate|"In Treatment Course 1:
~• Given Intrathecally on day 15 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~In Treatment Course 2:
~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~In Treatment Course 3:
~Intrathecally on day 1 at the age-defined dose"
16327947|NCT00439296|Drug|Cyclophosphamide|Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.
16327948|NCT00439296|Drug|6-thioguanine|Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.
16327949|NCT00439283|Drug|infliximab|
16327950|NCT00439283|Drug|methotrexate|
16327951|NCT00439270|Drug|Dasatinib|Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
16327952|NCT00439270|Drug|Docetaxel|Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
16327953|NCT00439244|Drug|Zoledronic acid|Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.
16327954|NCT00439244|Drug|Placebo|Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle
16327955|NCT00439244|Drug|Teriparatide|"Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL.
~Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days."
16327956|NCT00439231|Drug|Lenalidomide|Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
16327957|NCT00439218|Drug|sodium phenylbutyrate|500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD.
16327958|NCT00439205|Device|FastEEM4 System|The FastEEM4 probe is moved toward the edge of the lesion(s) until it measures what appears to be normal mouth tissue.
16327959|NCT00439205|Device|Multispectral Digital Microscope|The MDM instrument will take pictures of abnormal-appearing and normal-appearing areas in the mouth.
16327960|NCT00439192|Drug|ELB245|
16327961|NCT00439192|Drug|Tolterodine|
16327962|NCT00439179|Drug|cohort 1|Weekly gem + GW572016, 1000mg/day (combination)
16327963|NCT00439179|Drug|cohort 2|Weekly gem + GW572016, 1500 mg/day (combination)
16327964|NCT00439179|Drug|cohort 3|GEMOX + GW572016 1000 mg/day (combination)
16327965|NCT00439179|Drug|cohort 4|GEMOX + GW572016 1500 mg/day (combination)
16327966|NCT00439166|Drug|doxycycline|capsule, 100 mg, b.i.d., daily for 1 year
16327967|NCT00439166|Drug|rifampicin|capsule, 300mg, o.d., daily for 11 months (administration starts in 2nd month of trial)
16327968|NCT00439166|Drug|Placebo matched to doxycycline|Doxycycline-matched - blue capsule, b.i.d.,daily for 12 months
16327969|NCT00439166|Drug|Placebo matched to Rifampin|Rifampin-matched - red capsule, o.d., daily for 11 months starting at month 2.
16327970|NCT00439153|Device|Tourniquet instrument capable of measuring LOP in combination with tourniquet cuffs|See Detailed Description.
16327971|NCT00439140|Biological|botulinum toxin Type A|Botulinum toxin Type A injection into the detrusor.
16327972|NCT00439140|Drug|Normal Saline (Placebo)|Placebo (Normal Saline) injection into the detrusor.
16327973|NCT00439101|Drug|Megstrol Acetate|Megestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days.
16327974|NCT00439101|Other|Placebo|Placebo (lemon-lime suspension) taken orally for 90 days.
16327975|NCT00439075|Procedure|CPAP|
16327976|NCT00439075|Drug|standard treatment|
16327977|NCT00439062|Drug|Roxithromycin|
16327978|NCT00439049|Drug|modafinil|400 mg daily
16327979|NCT00439049|Drug|d-amphetamine|60mg daily
16327980|NCT00439049|Drug|L-Dopa|800/200mg daily
16327981|NCT00439049|Drug|Naltrexone|50mg daily
16327982|NCT00439036|Behavioral|Behavior Therapy|The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.
16327983|NCT00439036|Behavioral|Drug Counseling|
16327984|NCT00439023|Procedure|dialysis with glucose in dialysis water|
16327985|NCT00439010|Drug|[123I] AV 39|
16327986|NCT00438984|Drug|cyclophosphamide|Given IV
16327987|NCT00438984|Biological|therapeutic autologous lymphocytes|Given IV
16327988|NCT00438984|Biological|aldesleukin|Given IV or SC
16327989|NCT00438984|Other|immunohistochemistry staining method|Correlative studies
16327990|NCT00438984|Procedure|biopsy|Optional correlative studies
16327991|NCT00438984|Other|laboratory biomarker analysis|Correlative studies
16327992|NCT00438984|Other|immunologic technique|Correlative studies
16327993|NCT00438984|Genetic|polymerase chain reaction|Correlative studies
16327994|NCT00438971|Drug|Duloxetine|Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.
16327995|NCT00438958|Biological|filgrastim|Given on day 0.
16327996|NCT00438958|Procedure|allogeneic bone marrow transplantation|Given on day 0
16327997|NCT00438958|Procedure|peripheral blood stem cell transplantation|Given on day 0
16327998|NCT00438945|Drug|Eprosartan|
16327999|NCT00438932|Drug|Lanthanum Carbonate|Lanthanum carbonate 1000mg 3x/day
16328000|NCT00438932|Dietary Supplement|Low Phosphorus Diet|Low phosphorus diet will consist of 800 mg of phosphorus per day.
16328001|NCT00438932|Dietary Supplement|Unrestricted Phosphorus Diet|Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
16328002|NCT00438932|Drug|Placebo|Lanthanum Carbonate placebo given three times a day with meals.
16328003|NCT00438919|Device|drug-eluting stent|CYPHER SELECT™ Sirolimus-eluting Coronary Stent
16328004|NCT00438906|Procedure|Biopsy, Fine Needle Aspiration (FNA)|If a pancreatic lesion of concern is identified, a small needle is inserted in the lesion in the pancreas and cells of the lesion are aspirated. Diagnosis of the lesion can typically occur with FNA.
16328005|NCT00438906|Drug|Secretin (human synthetic) - ChiRhoClin|Secretin is a synthetic human hormone that encourages the pancreas to create fluid. This will allow pancreatic juice to be collected via gentle suction in the duodenum where the pancreatic juice naturally flows.
16328006|NCT00438893|Dietary Supplement|Dietary portfolio of cholesterol-lowering foods|A plant based dietary portfolio providing plant sterols (1.0g/1000 kcal), soy protein (22.5g/1000 kcal, viscous fibers 10 g/1000 kcal and almonds 22.5g/1000 kcal)
16328007|NCT00438880|Drug|Agatolimod Sodium|Given IV
16328008|NCT00438880|Radiation|Indium In-111 Ibritumomab Tiuxetan|Given IV
16328009|NCT00438880|Other|Laboratory Biomarker Analysis|Correlative study
16328010|NCT00438880|Procedure|Radionuclide Imaging|Undergo imaging scans
16328011|NCT00438880|Biological|Rituximab|Given IV
16328012|NCT00438880|Procedure|Single Photon Emission Computed Tomography|Undergo imaging scans
16328013|NCT00438880|Radiation|Yttrium Y-90 Ibritumomab Tiuxetan|Given IV
16328014|NCT00438867|Genetic|Ad5FGF-4|Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
16328015|NCT00438867|Genetic|Placebo|Control group
16328016|NCT00438854|Drug|Dasatinib|Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
16328017|NCT00438841|Drug|bortezomib|
16328018|NCT00438841|Drug|cyclophosphamide|
16328019|NCT00438841|Drug|dexamethasone|
16328020|NCT00438841|Drug|thalidomide|
16328021|NCT00438828|Drug|dexamethasone|8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
16328022|NCT00438815|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
16328023|NCT00438802|Drug|Alefacept|Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8
16328024|NCT00438789|Drug|eculizumab|600mg IV every week and 900mg IV every 2 weeks
16328025|NCT00438776|Drug|olanzapine|2.5mg to 15mg daily
16328026|NCT00438776|Drug|sugar pill|matching placebo to olanzapine
16328027|NCT00438750|Other|Independent Excercises|Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.
16328028|NCT00438750|Other|Occupational Therapy|Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.
16328029|NCT00438737|Biological|bevacizumab|
16328030|NCT00438737|Biological|cetuximab|
16328031|NCT00438737|Drug|fluorouracil|
16328032|NCT00438737|Drug|leucovorin calcium|
16328033|NCT00438737|Drug|oxaliplatin|
16328034|NCT00438737|Procedure|adjuvant therapy|
16328035|NCT00438737|Procedure|conventional surgery|
16328036|NCT00438737|Procedure|neoadjuvant therapy|
16328037|NCT00438724|Behavioral|Information, counseling and support|
16328038|NCT00438698|Other|Low Glycemic Index diet|Diet to emphasize carbohydrate foods low in glycemic index
16328039|NCT00438698|Other|High Cereal Fibre Diets|Diet to emphasize whole wheat carbohydrate cgoices
16328040|NCT00438685|Behavioral|Outpatient MST/OPTION-A|
16328041|NCT00438685|Behavioral|Usual Services|
16328042|NCT00438672|Drug|Placebo Injection|Injection without steroid
16328043|NCT00438672|Drug|Steroid (dexamethasone) Injection|Injection with steroid (dexamethasone)
16328044|NCT00438659|Drug|mometasone furoate|Applied to treatment area
16328045|NCT00438659|Other|placebo|Applied to treatment area
16328046|NCT00438620|Behavioral|Home-based physical activity program|the role of physical activity as a Quality of Life intervention
16328047|NCT00438607|Drug|BIIB014|oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
16328048|NCT00438607|Drug|Placebo|Matched placebo for MTD or MTD-1
16328049|NCT00438594|Behavioral|home visitation|Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
16328050|NCT00438581|Drug|Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )|
16328051|NCT00438568|Drug|Regular Insulin|administered intra-nasally twice a day for 16 weeks
16328052|NCT00438568|Drug|Placebo|administered intra-nasally twice a day for 16 weeks
16328053|NCT00438555|Behavioral|Parents and children group|3 months workshops of parents and children intervention, guided by dietician and phycologist
16328054|NCT00438555|Behavioral|Parent's group|3 months workshop of parents intervention, guided by dietician and phycologist
16328055|NCT00438516|Behavioral|nurse home visitation|Nurse home visits from midway through pregnancy to child age 2
16328056|NCT00438503|Procedure|Procedure|
16328057|NCT00438490|Drug|Recombinant Human Prolactin|
16328058|NCT00438477|Drug|Isosulfan Blue|At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
16328059|NCT00438477|Procedure|Lymphangiography|2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
16328060|NCT00438477|Radiation|Technetium Tc 99m sulfur colloid|"At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection.
~At the time of surgery, patients receive isosulfan blue by subareolar injection."
16328061|NCT00438464|Drug|Finasteride|Given PO
16328062|NCT00438464|Other|Placebo|Given PO
16328063|NCT00438464|Procedure|Prostatectomy|Undergo prostatectomy
16328064|NCT00438464|Other|Laboratory biomarker analysis|Correlative studies
16328065|NCT00438451|Drug|Levetiracetam|LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.
16328066|NCT00438451|Drug|Carbamazepine|CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.
16328067|NCT00438451|Drug|Lamotrigine|LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.
16328068|NCT00438438|Behavioral|forced desynchrony protocol with sleep restriction|Subjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance.
16328069|NCT00438425|Dietary Supplement|Dietary Portfolio - Intensive|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 7 visits during a 6-month period with the study dietitian.
16328070|NCT00438425|Dietary Supplement|Dietary Portfolio - Routine|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 2 visits during a 6-month period with the study dietitian.
16328071|NCT00438425|Dietary Supplement|Control (low saturated fat therapeutic diet)|Dietitians advised participants to consume the following therapeutic diet components (<7% of energy saturated fat, <200 mg/d cholesterol) with a focus on low-fat dairy and whole grain cereals together with fruit and vegetables as part of a low fat vegetarian diet, and avoidance of the specific portfolio components.
16328072|NCT00438399|Drug|C. propionate - Corticosteroid 1|Twice daily application
16328073|NCT00438399|Drug|C. propionate- Corticosteroid 2|Twice daily application
16328074|NCT00438399|Drug|C. propionate -Corticosteroid 3|Twice daily application
16328075|NCT00438399|Drug|Corticosteroid 1- C. propionate|Twice daily application
16328076|NCT00438399|Drug|Corticosteroid 2 - C. propionate|Twice daily application
16328077|NCT00438399|Drug|Corticosteroid 3 - C. propionate|Twice daily application
16328078|NCT00438386|Drug|Aripiprazole|
16328079|NCT00438360|Drug|Cyclosporine A microemulsion|Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations
16328080|NCT00438360|Drug|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
16328081|NCT00438347|Behavioral|Aerobic Exercise|One hour per day three times a week for one year
16328082|NCT00438347|Behavioral|Stretching and toning|One hour per day three times a week for one year
16328083|NCT00438334|Device|Programmable directional/omni-directional hearing aid|
16328084|NCT00438321|Drug|Zoladex|
16328085|NCT00438321|Drug|Testosterone gel|
16328088|NCT00438295|Procedure|temperature control|
16328089|NCT00438282|Behavioral|home visitation|Home visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.
16328090|NCT00438269|Drug|Site-specific empiric regimens included: Meropenem|
16328091|NCT00438269|Drug|Piperacillin/tazobactam|
16328092|NCT00438269|Drug|Ciprofloxacin and cefazolin +/- metronidazole|
16328093|NCT00438256|Procedure|Proton Beam Radiation|Given over different schedules and duration
16328094|NCT00438256|Drug|Capecitabine|Given orally starting on day one of radiation therapy for 2 weeks
16328095|NCT00438243|Drug|Bromfenac (Xibrom)|1 drop to affected eye twice daily.
16328096|NCT00438243|Drug|Refresh Plus|1 drop in the affected eye twice daily
16328097|NCT00438230|Drug|Warfarin|
16328098|NCT00438217|Drug|Triptorelin (GnRH agonists)|
16328099|NCT00438217|Drug|Leuprolide (GnRH agonists)|
16328100|NCT00438204|Biological|bevacizumab|Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
16328101|NCT00438204|Drug|gemcitabine hydrochloride|Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
16328102|NCT00438204|Drug|pemetrexed disodium|Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.
16328103|NCT00438178|Drug|Obatoclax mesylate (GX15-070MS)|
16328104|NCT00438165|Behavioral|home visitation|Home visitation by nurses from midway through pregnancy until child age 12
16328105|NCT00438152|Drug|Saquinavir (Invirase®)|Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks
16328106|NCT00438152|Drug|Lopinavir/ritonavir (Kaletra®)|Lopinavir/ritonavir 400/100 mg BD 24 weeks
16328107|NCT00438139|Drug|Dronabinol|
16328108|NCT00438126|Behavioral|A lifestyle educational program|
16328109|NCT00438113|Drug|Aggressive Blood Pressure control|Aggressive Blood Pressure therapy, alone or combination therapy, to reach a target BP equal to or less than 120/80 mmHg
16328110|NCT00438100|Drug|Capecitabine|1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
16328111|NCT00438100|Drug|S-1|80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
16328112|NCT00438087|Drug|methylprednisolone|methylprednisolone administrated intra and post operatively
16328113|NCT00438061|Behavioral|Weight loss by dietary restriction|
16328114|NCT00438048|Procedure|pilocarpine|or secondary symptomatic SS with clinically significant dry mouth were randomized to receive either 5 mg oral Pilocarpine solution (5ml) or artificial saliva (5 ml) 3 times a day for 12 weeks
16328115|NCT00438048|Drug|Artificial Saliva|5ml 3 times daily
16328116|NCT00438035|Procedure|ECG spectral|
16328117|NCT00438009|Drug|Coxsackievirus A21|Two doses of drug, separated by 48 hours
16328118|NCT00437996|Drug|Clonidine|
16328119|NCT00437996|Drug|Levobupivacaine|
16328120|NCT00437996|Drug|Sufentanil|
16328121|NCT00437983|Dietary Supplement|PS-Omega3|Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
16328122|NCT00437983|Dietary Supplement|Placebo|Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
16328123|NCT00437970|Drug|Pioglitazone|15mg of Pioglitazone taken orally twice a day
16328124|NCT00437970|Drug|Metformin|500 mg of Metformin taken orally twice a day
16328125|NCT00437957|Drug|Temozolomide|75 Mg/m2/day for all Cohorts
16328126|NCT00437957|Drug|Valproic Acid|Cohort 1: 20 mg/kg/day Cohort 2: 30 mg/kg/day Cohort 3: 40 mg/kg/day Cohort 4: 50 mg/kg/day
16328127|NCT00437957|Procedure|Whole Brain Radiation Therapy|Concurrently with Temozolomide and VPA
16328128|NCT00437918|Drug|nateglinide|
16328129|NCT00437918|Drug|acarbose|
16328130|NCT00437905|Procedure|angioplasty|
16328131|NCT00437892|Drug|atorvastatin|tablets, 40 mg day, 3 months
16328132|NCT00437892|Drug|atorvastatin|tablets, 40 mg once daily
16328133|NCT00437892|Behavioral|diet|daily
16328134|NCT00437892|Behavioral|diet|daily diet
16328135|NCT00437853|Drug|Anastrozole|
16328136|NCT00437840|Drug|GSK598809|GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose.
16328137|NCT00437840|Drug|Placebo|Subjects will receive single oral dose of matching placebo tablet to GSK598809.
16328138|NCT00437827|Other|Star*D algorithm|Standard of care based upon the therapies selected in the Star*D study.
16328139|NCT00437827|Other|rEEG-guided therapy|An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.
16328140|NCT00437814|Drug|Ketamine, effect on intracranial pressure|
16328141|NCT00437762|Drug|Botulinum Toxin A Injection|Botulinum Toxin A Injection
16328142|NCT00437762|Drug|Placebo injection|Placebo Injection
16328143|NCT00437749|Drug|CBT-1|(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
16328144|NCT00437749|Other|Placebo|(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
16328145|NCT00437736|Drug|APO010|APO010 starting at 2.5 µg/m² IV on D1, D15, D22 and D29 followed by a two-week drug rest.
16328146|NCT00437723|Drug|epoetin beta [NeoRecormon]|At a dose to achieve and maintain an Hb level of 120-135g/dL.
16328147|NCT00437710|Procedure|cell therapy, bone marrow derived stem cell|
16328148|NCT00437697|Drug|dalteparin|
16328149|NCT00437684|Drug|LPV/r|200/50 mg 2 cpr bid monotherapy
16328150|NCT00437684|Drug|PEG-IFNa 2a|PEG-IFNa 2a 180 mcg/week
16328151|NCT00437684|Drug|Ribavirin|Ribavirin 1-1.2 g/day
16328152|NCT00437684|Drug|NUCS|Nucleoside Reverse Transcriptase Inhibitors
16328153|NCT00437671|Drug|Tetanus Immune Globulin (Human)|Based on package insert recommendation and recommendations of WHO
16328154|NCT00437671|Biological|Diphtheria-Tetanus Toxoids Adsorbed|Based on package insert recommendations and recommendations of WHO
16328155|NCT00437658|Drug|Elagolix|Provided as tablets for oral administration
16328156|NCT00437658|Drug|Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)|Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
16328333|NCT00436566|Drug|lapatinib ditosylate|
16328157|NCT00437658|Drug|Placebo to Elagolix|Matching placebo tablets for oral administration
16328158|NCT00437658|Drug|Placebo to DMPA-SC|Matching placebo for subcutaneous injection in a pre-filled syringe
16328159|NCT00437645|Drug|Valsartan 160 mg capsules|
16328160|NCT00437645|Drug|Amlodipine 5 mg capsules|
16328161|NCT00437645|Drug|placebo|capsules
16328162|NCT00437632|Drug|GSK598809|GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
16328163|NCT00437632|Drug|Placebo|Subjects will receive matching placebo capsules to GSK598809 orally with water.
16328164|NCT00437632|Drug|Caffeine|Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
16328165|NCT00437619|Drug|calcipotriol hydrate [Daivonex]|50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4.
16328166|NCT00437606|Drug|GK Activator (2)|100mg po
16328167|NCT00437606|Drug|Ethanol|40g po
16328168|NCT00437593|Procedure|ppVE, MP, ICG|surgery with ILM staining
16328169|NCT00437593|Procedure|ppVE, MP, MB|Surgery with ERM staining
16328170|NCT00437580|Drug|Lactobacillus casei rhamnosus (strain Lcr 35 LC)|Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic or to a 5 weeks regimen with placebo.
16328171|NCT00437567|Dietary Supplement|Galacto-oligosaccharide (GOS)|Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
16328172|NCT00437567|Other|Placebo|Similar quantity of sterile water to be added to milk
16328173|NCT00437554|Drug|Glimepiride|
16328174|NCT00437541|Device|Insulation retrofitted into house|
16328175|NCT00437502|Biological|tumor peptide vaccine|Cohort 1 low dose level of vaccine @ 0.3 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.
16328176|NCT00437502|Biological|tumor peptide vaccine|Cohort 2 high dose vaccine @ 1 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.
16328177|NCT00437489|Drug|Inhaled Human Insulin (Exubera)|Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
16328178|NCT00437489|Drug|Inhaled Human Insulin (Exubera)|Initial dose of 1mg TID of inhaled human insulin
16328179|NCT00437476|Drug|LPV/r|Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)
16328180|NCT00437476|Drug|Nucleoside Reverse Transcriptase Inhibitors|NRTIs for 26 weeks (A) or 24 weeks (B)
16328181|NCT00437476|Drug|PEG-IFNa 2a|PEG-IFNa 2a 180 mcg/week (48 weeks)
16328182|NCT00437476|Drug|Ribavirin|Ribavirin 1-1.2 g/day (48 weeks)
16328183|NCT00437463|Drug|Ramipril|2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
16328184|NCT00437450|Drug|Epoetin/Atra|
16328185|NCT00437437|Drug|Brivanib|Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression
16328186|NCT00437424|Drug|Brivanib|Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
16328187|NCT00437411|Behavioral|Affective Self-Awareness workshop|Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices.
16328188|NCT00437398|Biological|Islet Transplant|Purified pancreatic islets
16328189|NCT00437385|Drug|TCAs, SSRIs, NARIs, SNRIs, Lithium|Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
16328190|NCT00437385|Procedure|Electroconvulsive therapy|ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions.
16328191|NCT00437385|Behavioral|Cognitive behavioral group therapy|"The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called EffECTive. This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up."
16328192|NCT00437372|Drug|Sunitinib|"The use of the FDA approved drug sunitinib, used in an off-label manner with external beam radiation therapy."
16328193|NCT00437372|Radiation|External Beam Radiation Therapy|Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.
16328194|NCT00437359|Drug|Toremifene citrate|Toremifene citrate: 40-mg tablets by mouth once daily.
16328195|NCT00437359|Drug|Anastrozole|Anastrozole: 1-mg tablets by mouth once daily.
16328196|NCT00437346|Procedure|Individualized and comprehensive information|Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.
16328197|NCT00437346|Drug|Lanzo Melt|30mg, od, 1/2 h before meal
16328198|NCT00437346|Drug|Lanzo Melt|30mg, od, 1/2 h before meal
16328199|NCT00437333|Drug|Metformin cloridrate|
16328200|NCT00437320|Procedure|Metvix PDT|Metvix PDT
16328201|NCT00437320|Procedure|placebo|placebo
16328202|NCT00437307|Drug|Topotecan|Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
16328203|NCT00437294|Drug|enzastaurin|1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease
16328334|NCT00436566|Drug|paclitaxel|
16328204|NCT00437294|Drug|placebo|oral, daily, 21-day cycles until progressive disease
16328205|NCT00437294|Drug|capecitabine|1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
16328206|NCT00437281|Drug|Placebo|Placebo
16328207|NCT00437281|Drug|Pregabalin|Orally-administered pregabalin
16328208|NCT00437268|Drug|enzastaurin|1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease
16328209|NCT00437268|Drug|irinotecan|300 milligrams per square meter (mg/m^2) intravenously on Day 1 of each 21-day cycle until progressive disease
16328210|NCT00437268|Drug|cetuximab|400 mg/m^2, intravenously on Day 1, 250 mg/m^2 on Day 8, Day 15 Cycle 1 then 250 mg/m^2, on Day 1, 8 and 15 of each cycle, intravenously 21-day cycles until progressive disease
16328211|NCT00437255|Drug|Clobetasol Propionate, 0.05%|Topical, twice daily for 4 weeks
16328212|NCT00437255|Drug|Calcipotriene and betamethasone dipropionate ointment|Topical, once daily
16328213|NCT00437242|Drug|Odiparcil|
16328214|NCT00437229|Drug|Casopitant (GW679769) Oral Tablets|Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
16328215|NCT00437229|Drug|dexamethasone|Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
16328216|NCT00437229|Drug|ondansetron|Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
16328217|NCT00437216|Drug|Clobetasol Propionate, 0.05%|Apply twice daily for 2 or 4 weeks as monotherapy
16328218|NCT00437216|Drug|Clobetasol propionate, 0.05% Spray|Apply twice daily for 2 or 4 weeks as add-on therapy
16328219|NCT00437203|Drug|PF-00477736|"Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
~If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion."
16328220|NCT00437203|Drug|gemcitabine|gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
16328221|NCT00437190|Device|ATLANTIS™ Cervical Plate System and allograft|Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
16328222|NCT00437190|Device|BRYAN Cervical Disc Prosthesis|The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.
16328223|NCT00437177|Drug|apomorphine|Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
16328224|NCT00437177|Drug|[(123)I] iodobenzamide|[(123)I] iodobenzamide 185 MBq I.V., at discharge.
16328225|NCT00437164|Drug|Insulin|
16328226|NCT00437164|Drug|Oral GW677954 Capsules (15 mg)|
16328227|NCT00437151|Other|More frequent than normal office visits|Mode of patient reminder
16328228|NCT00437151|Other|Electronic reminders (voice, e-mail, text messages)|Mode of patient reminder
16328229|NCT00437151|Other|Parenteral involvement / intervention reminders|Mode of patient reminder
16328230|NCT00437151|Other|No intervention or reminders|Mode of patient reminder
16328231|NCT00437138|Behavioral|Exposure to dilute diesel exhaust (300µg/m3) or filtered air|
16328232|NCT00437125|Drug|Duloxetine hydrochloride|Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks
16328233|NCT00437112|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 weeks
16328234|NCT00437112|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 24 weeks
16328235|NCT00437099|Drug|Omacor®|arm 1: Omacor 1680 Arm 2: Omacor 3360
16328236|NCT00437099|Drug|Placebo|Placebo
16328237|NCT00437086|Drug|PS-341|1.6 mg/m2 by IV; 4 out of 5 weeks
16328238|NCT00437073|Drug|capecitabine|capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days
16328239|NCT00437073|Drug|topotecan|topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days
16328240|NCT00437073|Drug|lapatinib|lapatinib administered 1250mg once daily orally
16328241|NCT00437060|Procedure|Cognitive Assessment|Ancillary studies
16328242|NCT00437060|Procedure|Diffusion Tensor Imaging|Correlative studies
16328243|NCT00437060|Other|Laboratory Biomarker Analysis|Correlative studies
16328244|NCT00437060|Other|Pharmacological Study|Correlative studies
16328245|NCT00437060|Procedure|Psychosocial Assessment and Care|Ancillary studies
16328246|NCT00437034|Biological|aflibercept|Given IV
16328247|NCT00437021|Drug|Placebo (subcutaneous)|0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia [Sterile Saline Placebo (SSP)].
16328248|NCT00437021|Drug|Placebo (scarification)|Physiologic normal saline for injection.
16328249|NCT00437021|Biological|Dryvax®|Dryvax® Vaccinia Vaccine (~10^5 [plaque forming units (pfu)/dose] given via scarification, titer 10^8 pfu per mL after reconstitution).
16328250|NCT00437021|Biological|IMVAMUNE®|IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
16328251|NCT00437008|Drug|Benfotiamine 1050mg, 3 days|
16328252|NCT00437008|Behavioral|high-AGE vs. low-AGE meal|
16328253|NCT00436995|Drug|Darbepoetin Alfa|Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
16328254|NCT00436982|Device|Cemented Triathlon total knee system|Orthopaedic implant
16328255|NCT00436982|Device|Duracon total knee system|Orthopaedic implant
16328256|NCT00436969|Device|Orthovisc|Orthovisc injection
16328257|NCT00436969|Drug|Control|Celestone (betamethasone sodium phosphate and acetate) - 2 mL
16328258|NCT00436956|Procedure|Magnetic Resonance Imaging (DCE-MRI)|Scans evaluate tumor tissue and blood flow.
16328259|NCT00436956|Drug|AZD2171|20 mg oral daily for 28 days
16328260|NCT00436956|Drug|Prednisone|10mg orally daily in combination with AZD2171 20mg daily.
16328261|NCT00436943|Drug|nicotine replacement therapy and bupropion|3-6 months
16328262|NCT00436943|Behavioral|smoking cessation counseling and referrals|Organizational counseling and referrals
16328263|NCT00436930|Biological|autologous tumor cell vaccine|Given subcutaneously
16328264|NCT00436930|Biological|sargramostim|Given subcutaneously
16328265|NCT00436930|Biological|therapeutic autologous dendritic cells|Given subcutaneously
16328266|NCT00436917|Drug|zoledronic acid|zoledronic acid
16328267|NCT00436917|Procedure|Letrozole as adjuvant therapy|standard care
16328268|NCT00436904|Drug|Alemtuzumab|30 mg Monday, Wednesday, and Friday x 5 weeks
16328269|NCT00436904|Drug|Rituximab|375mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
16328270|NCT00436878|Behavioral|Food portion size|Each of four experiments involves a 2 x 2 within-subjects factorial design, in which the first factor is the portion size of a food served to children: foods will be served in a reference amount (i.e. 250 g macaroni and cheese) or doubled in size(i.e. 500 g of macaroni and cheese). In the Experiment 1, the second factor of the 2 x 2 design is meal type: whether the food is consumed at a meal or a snack. In experiment #2, the second factor is food type: fruit vs. vegetable. In experiment #3, the second factor is entree energy density: a regular energy density or a 40% greater energy density. In experiment #4, the second factor is plate size: a 6 inch plate vs. a 10 inch plate.
16328271|NCT00436865|Behavioral|Weight loss|
16328272|NCT00436852|Drug|ABT-751|Given orally
16328273|NCT00436852|Procedure|quality-of-life assessment|Ancillary studies
16328274|NCT00436839|Drug|Docetaxel|75mg/m² intravenously (day 1) every 21 days
16328275|NCT00436839|Drug|Mitoxantrone|12mg/m² intravenously every 21 days
16328276|NCT00436839|Drug|Prednisone|10mg orally given daily
16328277|NCT00436826|Drug|Cladribine|Participants were administered with cladribine tablets orally as cumulative dose.
16328278|NCT00436826|Drug|Placebo|Participants were administered with placebo orally.
16328279|NCT00436826|Drug|Interferon-beta (IFN-beta)|Participants received IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during both DB period of 96 weeks and OL extension period of 48 weeks.
16328280|NCT00436800|Drug|Gemcitabine|1000mg/m² over 10mg/m²/min
16328281|NCT00436800|Drug|Oxaliplatin|100 mg/m² over 2 hours.
16328282|NCT00436787|Drug|Fondaparinux Sodium|
16328283|NCT00436774|Procedure|assessment of therapy complications|
16328284|NCT00436774|Procedure|quality-of-life assessment|
16328285|NCT00436761|Biological|anti-thymocyte globulin|
16328286|NCT00436761|Biological|graft-versus-tumor induction therapy|
16328287|NCT00436761|Biological|sargramostim|
16328288|NCT00436761|Drug|busulfan|
16328289|NCT00436761|Drug|cyclosporine|
16328290|NCT00436761|Drug|melphalan|
16328291|NCT00436761|Drug|methylprednisolone|
16328292|NCT00436761|Other|flow cytometry|
16328293|NCT00436761|Other|immunologic technique|
16328294|NCT00436761|Other|laboratory biomarker analysis|
16328295|NCT00436761|Procedure|allogeneic hematopoietic stem cell transplantation|
16328296|NCT00436761|Procedure|umbilical cord blood transplantation|
16328297|NCT00436748|Drug|Darbepoetin Alfa|Administered by subcutaneous or intravenous injection
16328298|NCT00436748|Drug|Placebo|Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
16328299|NCT00436722|Drug|ATG (Fresenius Biotech)|ATG-Fresenius 9 mg/kg at induction
16328300|NCT00436709|Biological|bevacizumab|
16328301|NCT00436709|Biological|pegfilgrastim|
16328302|NCT00436709|Drug|cyclophosphamide|
16328303|NCT00436709|Drug|doxorubicin hydrochloride|
16328304|NCT00436709|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16328305|NCT00436709|Other|flow cytometry|
16328306|NCT00436709|Other|immunoenzyme technique|
16328307|NCT00436709|Other|immunologic technique|
16328308|NCT00436709|Other|laboratory biomarker analysis|
16328309|NCT00436709|Procedure|adjuvant therapy|
16328310|NCT00436709|Procedure|immunoscintigraphy|
16328311|NCT00436696|Other|Laboratory Biomarker Analysis|Correlative studies
16328312|NCT00436683|Drug|Fermagate|Film coated tablet 500mg
16328313|NCT00436683|Drug|Sevelamer HCl|tablet 800mg
16328314|NCT00436670|Biological|AMG 317 75 mg|75 mg SC weekly injection
16328315|NCT00436670|Biological|AMG 317 150 mg|150 mg SC once weekly injection
16328316|NCT00436670|Biological|AMG 317 300 mg|300 mg weekly SC injection
16328317|NCT00436670|Biological|Placebo|Placebo SC once weekly injection
16328318|NCT00436657|Drug|CHPP of Cisplatin|Starting dose of 100 mg/m^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.
16328319|NCT00436657|Procedure|Abdominal Surgery|Surgical removal of abdominal tumors.
16328320|NCT00436644|Drug|Lapatinib|1250 mg orally days 1 -28.
16328321|NCT00436644|Drug|Topotecan|3.2 mg/m2 IV over 30 min in 100mL D5W (5% dextrose in water) or 0.9% NS at days 1, 8 & 15.
16328322|NCT00436631|Behavioral|Dietary management of seizures|Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially. This is a 3-month study of this diet.
16328323|NCT00436618|Drug|Everolimus|Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
16328324|NCT00436605|Drug|dasatinib|
16328325|NCT00436592|Device|NeuroFlo™ Catheter|45 minute Treatment
16328326|NCT00436579|Drug|sorafenib tosylate|Given orally
16328327|NCT00436579|Other|pharmacological study|
16328328|NCT00436579|Procedure|assessment of therapy complications|Ancillary studies
16328329|NCT00436579|Other|laboratory biomarker analysis|Correlative studies
16328330|NCT00436566|Biological|trastuzumab|
16328331|NCT00436566|Drug|cyclophosphamide|
16328332|NCT00436566|Drug|doxorubicin hydrochloride|
16328335|NCT00436566|Genetic|gene expression analysis|
16328336|NCT00436566|Genetic|reverse transcriptase-polymerase chain reaction|
16328337|NCT00436566|Other|fluorophotometry|
16328338|NCT00436566|Other|laboratory biomarker analysis|
16328339|NCT00436566|Other|mass spectrometry|
16328340|NCT00436566|Procedure|adjuvant therapy|
16328341|NCT00436566|Procedure|quality-of-life assessment|
16328342|NCT00436553|Drug|Verteporfin Photodynamic Therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
16328343|NCT00436553|Drug|Ranibizumab|Ranibizumab 0.5 mg administered as an intravitreal injection.
16328344|NCT00436553|Drug|Verteporfin Placebo|To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
16328345|NCT00436553|Drug|Ranibizumab Placebo|To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.
16328346|NCT00436540|Drug|Clobetasol Propionate 0.05% Spray|Apply to affected areas twice daily
16328347|NCT00436540|Drug|Clobetasol Propionate 0.05% Foam|Apply to affected areas twice daily
16328348|NCT00436527|Drug|Metronidazole gel 1%|Applied once to a test site on the right or left cheek (as determined by a randomization design)
16328349|NCT00436514|Behavioral|diet and absorption of ColoPEG|4l of PEG during 2 days
16328350|NCT00436514|Procedure|Colonoscopy with colic videocapsule|2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)
16328351|NCT00436514|Procedure|Standard colonoscopy|1l of PEG the morning just before colonoscopy
16328352|NCT00436501|Drug|docetaxel|25 mg/m^2 given intravenously (IV) over 1 hour (+/- 10 minutes) following VEGF Trap every 3 weeks starting cycle 1 (21 day cycles)
16328353|NCT00436501|Biological|ziv-aflibercept|Starting dose 2 mg/kg given IV Cycle 0. Phase I Group: Every 3 weeks beginning with Cycle 0 (Completed 03/14/2008); Phase II Group: Every 3 weeks starting cycle 1 (Opened 05/09/2008).
16328354|NCT00436501|Other|laboratory biomarker analysis|Correlative studies
16328355|NCT00436501|Other|pharmacological study|Correlative studies
16328356|NCT00436475|Drug|Vitamin D3 2,000 IU orally once daily|Vitamin D3 2,000 IU orally once daily
16328357|NCT00436475|Drug|Calcium Carbonate 400 mg orally twice daily|Calcium Carbonate 400 mg orally twice daily
16328358|NCT00436475|Drug|Vitamin D3-Placebo|Vitamin D3-Placebo
16328359|NCT00436475|Drug|Calcium-Placebo|Calcium-Placebo
16328360|NCT00436449|Drug|Avotermin|
16328361|NCT00436436|Drug|O6-benzylguanine|
16328362|NCT00436436|Drug|temozolomide|
16328363|NCT00436423|Drug|gemcitabine, TS-1|
16328364|NCT00436410|Biological|colloidal gold-bound tumor necrosis factor|
16328365|NCT00436410|Other|electron microscopy|
16328366|NCT00436410|Other|pharmacological study|
16328367|NCT00436410|Procedure|conventional surgery|
16328368|NCT00436397|Radiation|radiation therapy|
16328369|NCT00436384|Procedure|Monitoring-blood samples drawn for CMV testing|
16328370|NCT00436371|Drug|Amisulpride|Oral tablets
16328371|NCT00436358|Other|Not applicable: none|Please refer to the detailed description section
16328372|NCT00436345|Drug|Remifentanil|analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
16328373|NCT00436345|Drug|Propofol|conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
16328374|NCT00436332|Biological|bevacizumab|
16328375|NCT00436332|Drug|erlotinib hydrochloride|
16328376|NCT00436319|Procedure|Duration of GnRH agonist downregulation|"This is a randomized controlled trial. Patients will be randomized to two groups during the first consultation. GnRH agonist will be administrated according to the long luteal protocol. Down-regulation of the pituitary will be controlled on the first day of the menstrual period.
~The purpose of this study is to compare the pregnancy rates between the two groups. In the eventuality that pituitary down-regulation has not been confirmed (down-regulation levels determined as Ε2<80 pg/ml and progesterone <1.6 ng/ml), the patient will be assigned to a third group (group 3) and ovarian stimulation will only be initiated after down-regulation has been confirmed.
~The GnRH agonist that will be administrated is Buserelin Acetate. Recombinant FSH will be used for the ovarian stimulation and dose determination will be based on patient characteristics and previous history."
16328377|NCT00436306|Behavioral|Individualized Intervention|Individualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention.
16328378|NCT00436306|Behavioral|Computer-based contraceptive information|Contraceptive method information is provided on a computer.
16328379|NCT00436293|Drug|Docetaxel|75 mg/m²
16328380|NCT00436293|Drug|Cisplatin|75 mg/m²
16328381|NCT00436280|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
16328382|NCT00436280|Drug|gemcitabine|1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
16328383|NCT00436280|Drug|rituximab|375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
16328384|NCT00436280|Drug|oxaliplatin|100 mg/m², IV, once every two weeks, four to eight 2 week cycles
16328385|NCT00436267|Drug|fluorouracil|
16328386|NCT00436267|Radiation|selective external radiation therapy|
16328387|NCT00436267|Radiation|tomotherapy|
16328388|NCT00436267|Radiation|yttrium Y 90 glass microspheres|
16328389|NCT00436267|Radiation|yttrium Y 90 resin microspheres|
16329767|NCT00425906|Other|Placebo|
16328397|NCT00436241|Drug|Oxaliplatin|85mg/m2 iv on day 1 of each 2 week cycle
16328398|NCT00436241|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-10 of each 2 week cycle
16328399|NCT00436215|Drug|Bevacizumab|bevacizumab 5 mg/kg intravenous (IV) every two weeks
16328400|NCT00436215|Drug|BAY 43-9006|BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
16328401|NCT00436202|Behavioral|Iron supplement|
16328402|NCT00436189|Procedure|Blood Draw|
16328403|NCT00436176|Behavioral|Expanded Chronic Care Model|Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.
16328404|NCT00436163|Drug|Peginterferon alfa-2a|180 mcg subcutaneously once per week for 48 weeks.
16328405|NCT00436150|Behavioral|Interpersonal therapy-based treatment|Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend weekly 1-hour sessions for 5 weeks.
16328406|NCT00436150|Behavioral|Standard care|Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.
16328407|NCT00436137|Behavioral|Patient mailing|Patient will receive a mailing recommending colonoscopy, followed by telephone outreach
16328408|NCT00436124|Drug|oseltamivir [Tamiflu]|
16328409|NCT00436098|Behavioral|Motorpedagogic exercise|physical training
16328410|NCT00436085|Behavioral|Cognitive behavioral stress management training|
16328411|NCT00436072|Drug|ZD6474|Orally on a daily basis
16328412|NCT00436072|Drug|Cetuximab|Infusion once weekly
16328413|NCT00436072|Drug|Irinotecan|Infusion once the safe dose of ZD6474 and cetuximab is established
16328414|NCT00436059|Drug|bortezomib|
16328415|NCT00436046|Biological|Trivalent inactivated influenza virus vaccine (2006-2007 formulation)|Commercially available trivalent inactivated influenza virus vaccine without or with 1 of 2 dosages of commercially available type 1 interferon administered once by nasal instillation. Dosages: 0.6 ml of IVV or 0.7 ml of IVV.
16328416|NCT00436046|Biological|Type 1 interferon|Commercially available lyophilized IFN; dosages 1 M unit (Mu) of IFN; 10 M units (Mu) of IFN.
16328417|NCT00436033|Drug|milnacipran|
16328418|NCT00436033|Drug|Placebo|
16328419|NCT00436020|Device|TMS|Transcranial Magnetic Stimulation
16328420|NCT00436020|Device|Sham TMS|Sham Transcranial Magnetic Stimulation
16328421|NCT00436007|Biological|GSK 257049|GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine
16328422|NCT00436007|Biological|Tritanrix™ HepB/Hib|GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)
16328423|NCT00436007|Biological|Rouvax™|Aventis Pasteur's attenuated measles vaccine.
16328424|NCT00436007|Biological|Stamaril™|Aventis Pasteur's attenuated yellow fever vaccine.
16328425|NCT00436007|Biological|Polio Sabin™|GSK Biologicals' oral polio virus vaccine
16328426|NCT00435994|Drug|Inhaled primatene will be given as a breathing treatment|While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
16328427|NCT00435994|Other|Nasal Washing|1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence
16328428|NCT00435981|Drug|rhGAD65 formulated in Alhydrogel® (Diamyd®)|
16328429|NCT00435968|Drug|CVT E002 (Cold-fX)|
16328430|NCT00435955|Procedure|High dose chemotherapy with autologous transplantation|
16328431|NCT00435955|Drug|Rituximab|
16328432|NCT00435942|Device|Relay Thoracic Stent-Graft|implant
16328433|NCT00435942|Procedure|Open Repair|Open surgery
16328434|NCT00435929|Drug|Ritonavir|100mg po bid
16328435|NCT00435929|Drug|saquinavir [Invirase]|1000mg po bid
16328436|NCT00435916|Drug|SGN-40|1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
16328437|NCT00435903|Device|Palm Pilot|
16328438|NCT00435890|Behavioral|Triage Liaison Physician|triage liaison physician stationed with nurses at the triage desk of the Emergency Department.
16328439|NCT00435864|Procedure|Blood test|The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.
16328440|NCT00435851|Drug|Thyrogen, thyroid hormone withdrawal, iode 131|
16328441|NCT00435838|Drug|No Intervention -- Observational study|
16328442|NCT00435825|Drug|peginterferon alfa-2a [Pegasys]|90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
16328443|NCT00435812|Biological|HEPLISAV and/or Placebo|Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
16328444|NCT00435812|Biological|Engerix-B|Intramuscular (IM) injections on Week 0, Week 4, and Week 24
16328445|NCT00435799|Procedure|corneal cross-linking (CCL)|
16328446|NCT00435799|Drug|Riboflavin/dextran eyedrops|
16328447|NCT00435799|Device|UV-X system|
16328448|NCT00435773|Procedure|Single Leeching|
16328449|NCT00435773|Procedure|Repeated Leeching after 4 weeks|
16328450|NCT00435773|Procedure|Placebo Leeching|
16328451|NCT00435760|Drug|Aclidinium bromide|200 micrograms, once daily, 1 day treatment
16328452|NCT00435760|Drug|Placebo Tiotropium|1 puff once daily, 1 day treatment
16328453|NCT00435760|Drug|Tiotropium|1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
16328454|NCT00435760|Drug|Placebo LAS34273|1 puff, 1 dat treatment
16328455|NCT00435747|Drug|PARECOXIB SODIUM|
16328456|NCT00435734|Behavioral|obesity intervention|
16328457|NCT00435721|Behavioral|Psychoeducation|
16328710|NCT00433784|Procedure|Blood sampling - platelet aggregation|
16328458|NCT00435708|Behavioral|5 portions fruit and vegetables/day|Participants consume > = 5 portions fruit and veg per day
16328459|NCT00435695|Drug|GSK163090|
16328460|NCT00435682|Drug|Botox (Allergan Inc., US)|
16328461|NCT00435669|Drug|Brivanib|Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME
16328462|NCT00435669|Drug|Brivanib|Tablet, Oral, Brivanib 800 mg, QD, until progression
16328463|NCT00435643|Procedure|nasal continuous positive airway pressure|After an average interval of three months, 10 patients with severe OSAS (AHI of more than 30 events per hour of sleep) treated with a mean nCPAP pressure of 11.2 ± 0.7 cm of H2O were reassessed and all mentioned measurements above were repeated
16328464|NCT00435630|Other|LapSim training|complete curriculum training on LapSim surgical simulator
16328465|NCT00435617|Device|Hand Mentor|Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
16328466|NCT00435604|Drug|Hylenex|
16328467|NCT00435591|Drug|Conivaptan|ampoule or premix bag
16328468|NCT00435591|Drug|placebo|ampoule or premix bag
16328469|NCT00435578|Drug|Glufosfamide|
16328470|NCT00435552|Procedure|Ease-It Spray|
16328471|NCT00435539|Drug|ocriplasmin|Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
16328472|NCT00435539|Drug|ocriplasmin|Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
16328473|NCT00435539|Drug|Sham Comparator|Intravitreal sham injection
16328474|NCT00435526|Biological|anti-CFA/I bovine IgG, and anti-CfaE bovine IgG|
16328475|NCT00435500|Drug|Fluoride varnish|
16328476|NCT00435487|Drug|Dalteparin ( Fragmin)|Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.
16328477|NCT00435487|Drug|Unfractionated heparin|Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).
16328478|NCT00435474|Procedure|Wound treatment|wound treatment (silver product, alginate and foam dressing)
16328479|NCT00435474|Procedure|wound treatment|wound treatment (honey product, alginate and foam dressing)
16328480|NCT00435474|Other|psycho-social support|psycho-social support (based on the structure in cognitive therapy)
16328481|NCT00435474|Other|relaxation therapy|relaxation therapy
16328482|NCT00435461|Drug|Fluticasone furoate and fexofenadine|Fluticasone furoate and fexofenadine
16328483|NCT00435448|Drug|Lonidamine|
16328484|NCT00435435|Drug|Disulfiram|
16328485|NCT00435435|Drug|Acamprosate|
16328486|NCT00435435|Drug|Naltexone|
16328487|NCT00435422|Procedure|Stroke volume optimization|Stroke volume optimization
16328488|NCT00435409|Drug|Sunitinib + Capecitabine|"Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.
~Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons."
16328489|NCT00435409|Drug|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
16328490|NCT00435396|Biological|GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A|Intramuscular injection, 3 doses
16328491|NCT00435370|Drug|Tropisetron|10 mg/day
16328492|NCT00435370|Drug|Placebo|placebo
16328493|NCT00435370|Drug|Risperidone|6mg/day
16328494|NCT00435357|Device|mobile-bearing TKA|
16328495|NCT00435357|Device|fixed- bearing TKA|
16328496|NCT00435344|Behavioral|Pediatric Practice-Based Smoking Intervention|
16328497|NCT00435331|Drug|sapropterin dihydrochloride (6R-BH4)|2.5 mg/kg/day for two weeks, 5 mg/kg/day for two weeks, 10 mg/kg/day for four weeks, then 20 mg/kg/day for two days
16328498|NCT00435318|Procedure|Iontophoresis|
16328499|NCT00435305|Drug|Meropenem|
16328500|NCT00435305|Drug|Vancomycin|
16328501|NCT00435305|Drug|Linezolid|
16328502|NCT00435305|Drug|Piperacillin/Tazobactam|
16328503|NCT00435305|Drug|Cefepim|
16328504|NCT00435305|Drug|Ceftazidim|
16328505|NCT00435292|Drug|Naproxen|nonsteroidal anti-inflammatory drug
16328506|NCT00435292|Dietary Supplement|flavocoxid 250 mg|flavonoid mixture
16328507|NCT00435292|Dietary Supplement|flavocoxid 500 mg|flavonoid mixture
16328508|NCT00435279|Drug|Eszopiclone|Eszopiclone 3 mg
16328509|NCT00435279|Drug|Placebo|Placebo
16328510|NCT00435279|Drug|Venlafaxine|Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
16328511|NCT00435266|Procedure|Remote ischemic preconditioning|Inflation of blood pressure cuff 4 x 5 minutes during transportation to primary PCI
16328512|NCT00435253|Biological|BLVR Treatment|BLVR Treatment, 10 mL Hydrogel
16328513|NCT00435240|Behavioral|Paleolithic diet|
16328514|NCT00435227|Biological|Motavizumab|A single IM dose of 30 mg/kg will be administered on Day 0 of the study.
16328515|NCT00435227|Other|Placebo|A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.
16328516|NCT00435188|Behavioral|Multi-component physical activity counseling program|A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
16328517|NCT00435175|Drug|estradiol|
16328518|NCT00435162|Drug|Valsartan 0.25 mg/kg|once daily
16328519|NCT00435162|Drug|Valsartan 1.0 mg/kg|once daily
16328520|NCT00435162|Drug|Valsartan 4.0 mg/kg|once daily
16328521|NCT00435149|Procedure|Carpal tunnel release surgery|Patient will have carpal tunnel release surgery and will be put in a splint after surgery.
16328522|NCT00435149|Procedure|Carpal tunnel release surgery|Patient will have carpal tunnel release surgery and will have a bandage placed over the incision site after surgery.
16328523|NCT00435123|Dietary Supplement|Nutritional Supplement ProStat 64 twice a day|
16328524|NCT00435123|Dietary Supplement|Placebo supplement|Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
16328525|NCT00435110|Procedure|standard ventilatory settings|
16328526|NCT00435110|Procedure|PEEP and FiO2|
16328527|NCT00435084|Drug|APO866|
16328528|NCT00435071|Procedure|Carpal Tunnel Release Surgery|Patient will have large incision size during carpal tunnel release surgery.
16328529|NCT00435071|Procedure|Carpal tunnel release surgery|Patient will have a small incision size during carpal tunnel release surgery.
16328530|NCT00435058|Drug|timolol maleate 0,5%|
16328531|NCT00435058|Drug|brimonidine tartrate 0,2%|
16328532|NCT00435058|Drug|travoprost 0,004%|
16328533|NCT00435045|Drug|Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin|Lovaza + atorvastatin
16328534|NCT00435045|Drug|atorvastatin|atorvastatin + placebo
16328535|NCT00435032|Procedure|early appendectomy|Appendectomy within 24 hours of admission
16328536|NCT00435032|Procedure|interval appendectomy|Initial antibiotic treatment followed by appendectomy at 6-8 weeks
16328537|NCT00435019|Drug|insulin detemir|s.c. injection, once or twice daily.
16328538|NCT00435019|Drug|insulin NPH|s.c. injection, once or twice daily.
16328539|NCT00435019|Drug|insulin aspart|s.c. injection, at main meals.
16328540|NCT00434993|Drug|Albuterol Sulfate|"Albuterol sulfate, USP, solution for inhalation will be diluted as follows:
~The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution.
~The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution.
~A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first."
16328541|NCT00434993|Procedure|Mini-Bronchoalveolar Lavage (BAL)|The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3
16328542|NCT00434993|Drug|Placebo|"Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative.
~A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle).
~The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first."
16328543|NCT00434980|Behavioral|Family-Directed Cognitive Adaptation Program|
16328544|NCT00434967|Drug|Candesartan cilexetil|32 mg oral tablet
16328545|NCT00434967|Drug|Hydrochlorothiazide|25 mg oral tablet
16328546|NCT00434967|Drug|Candesartan/HCT 32/25 mg|
16328547|NCT00434954|Drug|exenatide twice daily (BID)|subcutaneous injection (5 mcg or 10 mcg), twice a day
16328548|NCT00434954|Drug|premixed insulin aspart twice daily (BID)|subcutaneous injection (titrated appropriately), twice a day
16328549|NCT00434941|Drug|Capecitabine|
16328550|NCT00434941|Radiation|Radiotherapy|
16328551|NCT00434915|Drug|DHEA|
16328552|NCT00434876|Drug|Quetiapine XR|Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.
16328553|NCT00434876|Drug|Placebo.|Inactive or inert pill which will be used as a comparator.
16328554|NCT00434863|Drug|botulinum toxin type A|
16328555|NCT00434850|Biological|Allogeneic Pancreatic Islet Cells|Preparation of allogeneic pancreatic islet cells injected into the portal vein of the liver
16328556|NCT00434850|Drug|Deoxyspergualin|An anti-inflammatory agent that blocks proinflammatory cytokine production and inhibits T-cells and B-cells and affects antigen presenting cells.
16328557|NCT00434850|Biological|Antithymocyte globulin|Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
16328558|NCT00434850|Biological|Daclizumab or basiliximab|Will replace antithymocyte globulin in all islet transplantations after the first one
16328559|NCT00434850|Drug|Sirolimus|Maintenance immunosuppressive therapy
16328560|NCT00434850|Drug|Tacrolimus|Maintenance immunosuppressive therapy
16328561|NCT00434850|Biological|Etanercept|Blocks TNF-alpha which is toxic to islet cells
16328562|NCT00434837|Procedure|Initial graft tension during ACL reconstruction surgery|"The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the High Tension treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the Low Tension treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown."
16328563|NCT00434824|Drug|Oral testosterone undecanoate (Andriol)|treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
16328564|NCT00434824|Drug|Placebo|treatment for 12 months with placebo in divided doses
16328565|NCT00434811|Biological|Allogeneic Pancreatic Islet Cells|200 ml suspension of allogenic human purified islets
16328566|NCT00434811|Biological|Antithymocyte Globulin|Participants will begin receiving ATG 2 days prior to the first islet transplant. ATG will continue to be given until Day 2 post-transplant.
16328567|NCT00434811|Drug|Sirolimus|Participants will begin receiving sirolimus 2 days prior to the first islet transplant and will be given for the duration of the study.
16328568|NCT00434811|Drug|Tacrolimus|On Day 1 post-transplant, participants will receive tacrolimus, which will also be taken for the duration of the study.
16328569|NCT00434811|Biological|Etanercept|Etanercept will be taken on the day of transplant and Days 3, 7, and 10 post-transplant.
16330455|NCT00421291|Behavioral|Education|
16328570|NCT00434811|Procedure|Islet Transplantation|Transplantation of pancreatic islet cell
16328571|NCT00434811|Biological|Basiliximab|Basiliximab will be used in place of ATG for the second and third transplants, if they are necessary.
16328572|NCT00434798|Biological|Campylobacter jejuni strains CG8421 and BH-01-0142|Campylobacter jejuni strains CG8421 and BH-01-0142 at a single dose. Dosing will be based on attack rate, to achieve a 75% attack rate. Anticipate use of 10^6-10^9 CFU
16328573|NCT00434785|Drug|AGG-523|
16328574|NCT00434772|Drug|glucagon|
16328575|NCT00434759|Behavioral|cognitive therapy|changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
16328576|NCT00434759|Behavioral|stepped care program based on cognitive therapy|starting with a digital-video-disk-based (DVD-based) self-help module (8 Sessions) followed by face-to-face-therapy including 8 or 16 sessions depending on remission status; including: changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
16328577|NCT00434746|Drug|ILV-094|Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo
16328578|NCT00434733|Biological|Pandemic influenza vaccine|
16328579|NCT00434720|Device|GlideScope Specific Stylet|
16328580|NCT00434694|Procedure|Pulmonary Vein Isolation (Radiofrequency Catheter Ablation)|
16328581|NCT00434681|Drug|paracetamol 4.8% paediatric oral suspension|
16328582|NCT00434668|Drug|cisplatin/docetaxel|
16328583|NCT00434668|Drug|cisplatin/vinorelbine|
16328584|NCT00434655|Procedure|Laparoscopic restrictive procedure|Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
16328585|NCT00434642|Drug|Carboplatin|Carboplatin was provided as commercially available drug.
16328586|NCT00434642|Drug|Gemcitabine|Gemcitabine was provided as commercially available drug.
16328587|NCT00434642|Drug|Bevacizumab|Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL [25 mg/mL]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
16328588|NCT00434642|Drug|Placebo|Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
16328589|NCT00434629|Drug|Bexxar|"Day 0: Tositumomab, IV (in the vein) followed by test dose of 131I-Tositumomab, IV (in the vein) to determine treatment dose of 131I-Tositumomab.
~1-2 weeks after Day 0: Tositumomab, IV (in the vein) followed by therapeutic dose 131I-Tositumomab (in the vein)."
16328590|NCT00434616|Procedure|Autologous bone marrow cell concentrate transplantation|bone marrow aspiration (240 ml), processing and reinjection
16328591|NCT00434616|Biological|saline injection|saline injections
16328592|NCT00434603|Behavioral|Expressive Arts--Theatre Skills Training Program|The experimental intervention was an intensive theatre skills training program. The group of adolescent participants recovering from ABI met daily for four hours over a period of 4 weeks. During this 4 hour period, regular breaks were scheduled to provide the participants with a mental and physical break from therapy. Theatre training included voice work, breathing, movement, physical warm-up, character development, script analysis, writing skills, three-dimensional awareness, group dynamics, story development, mask work and clowning among others.
16328593|NCT00434590|Drug|Enteric coated mycophenolate sodium (Myfortic®)|
16328594|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Low Dose|Single or two-dose intramuscular injection.
16328595|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Medium Dose|Single or two-dose intramuscular injection.
16328596|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A High Dose|Single or two-dose intramuscular injection.
16328597|NCT00434577|Biological|Herpes Zoster vaccine GSK1437173A Modified|Single or two-dose intramuscular injection.
16328598|NCT00434577|Biological|Placebo|Single intramuscular injection
16328599|NCT00434564|Procedure|Stress nuclear scan|
16328600|NCT00434538|Device|BST-DermOn|
16328601|NCT00434525|Procedure|Laparoscopic restrictive procedure|Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
16328602|NCT00434525|Procedure|Sleeve gastrectomy|Sleeve gastrectomy
16328603|NCT00434512|Biological|HIV vaccine 732461|
16328604|NCT00434499|Drug|EGCG|EGCG 400 mg by mouth twice/daily for 4 weeks duration.
16328605|NCT00434486|Drug|SKI-606|
16328606|NCT00434473|Drug|A-001|A-001
16328607|NCT00434473|Other|Placebo|Placebo
16328608|NCT00434460|Behavioral|Education|Implementation of clinical practice guideline for ventilator associated pneumonia through education.
16328609|NCT00434447|Drug|Zoledronic acid|
16328610|NCT00434434|Drug|omalizumab|Aged Liquid; subcutaneous repeating dose
16328611|NCT00434434|Drug|omalizumab|Lyophilized; subcutaneous repeating dose
16328612|NCT00434434|Drug|placebo|Subcutaneous repeating dose
16328613|NCT00434421|Drug|Glycerinated German cockroach allergenic extract|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
16328614|NCT00434421|Drug|Placebo|Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.
16328615|NCT00434408|Behavioral|chx once|4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
16328616|NCT00434408|Behavioral|CHX x 7 days|4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
16328617|NCT00434408|Behavioral|dry cord care|Household members are instructed to apply nothing to the newborn's umbilical cord stump.
16328618|NCT00434395|Drug|MOA-728|
16328619|NCT00434382|Drug|Sevoflurane|
16328620|NCT00434382|Drug|Isoflurane|
16328621|NCT00434382|Drug|Desflurane|
16328622|NCT00434382|Drug|Propofol|
16328623|NCT00434382|Drug|Fentanyl|
16328624|NCT00434382|Drug|Sufentanil|
16328625|NCT00434382|Drug|Alfentanil|
16328626|NCT00434382|Drug|Remifentanil|
16328627|NCT00434382|Device|Midlatency auditory evoked potentials|
16328628|NCT00434369|Drug|CoFactor (ANX-510)|
16328629|NCT00434356|Drug|bevacizumab|Intravenous repeating dose
16328630|NCT00434356|Drug|sunitinib|Oral repeating dose
16328631|NCT00434356|Drug|paclitaxel|Intravenous repeating dose
16328632|NCT00434343|Procedure|Physical Therapy|
16328633|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
16328634|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
16328635|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
16328636|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
16328637|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
16328638|NCT00434330|Drug|peginesatide|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
16328639|NCT00434317|Drug|Zoledronic acid|
16328640|NCT00434304|Drug|Ropinirole prolonged release/extended release(PR/XR)|Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).
16328641|NCT00434291|Drug|TG-873870(Nemonoxacin)|
16328642|NCT00434278|Drug|Dornase alfa|2.5 mg inhalation dose twice daily for 14±2 days
16328643|NCT00434278|Drug|placebo|2.5 mg inhalation dose twice daily for 14±2 days
16328644|NCT00434265|Behavioral|Physical training|
16328645|NCT00434252|Drug|bevacizumab|15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
16328646|NCT00434252|Drug|carboplatin|Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles
16328647|NCT00434252|Drug|paclitaxel|175 mg/m^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change)
16328648|NCT00434252|Drug|placebo|Administered by IV infusion on the first day of each 3-week cycle
16328649|NCT00434239|Drug|Lenalidomide + Ancestim|Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
16328650|NCT00434226|Drug|bevacizumab|Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
16328651|NCT00434226|Drug|sunitinib|25 mg/day for 2 weeks, followed by 1 week of rest
16328652|NCT00434226|Drug|carboplatin|On the first day of each cycle for 4 cycles
16328653|NCT00434226|Drug|paclitaxel|On the first day of each cycle for 4 cycles
16328654|NCT00434213|Drug|Daytrana|Methylphenidate Transdermal System (MTS)
16328655|NCT00434200|Procedure|long-term intensive exercise|
16328656|NCT00434187|Drug|ERB-041|
16328657|NCT00434174|Drug|Everolimus|"RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths.
~Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed."
16328658|NCT00434174|Drug|Pemetrexed|Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
16328711|NCT00433784|Procedure|Blood sampling - genotyping|
16329121|NCT00430898|Drug|Basiliximab|3 doses of 40mg, IV at baseline, week 2, and week 4
16328659|NCT00434161|Drug|Palifermin before only|One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 days before-high dose chemotherapy and one bolus IV injection at 60 μg/kg/day of matched placebo on days 0, 1 & 2 days after-high dose chemotherapy. Minimum of 4 days between before-chemotherapy and after-transplantation dosing.
16328660|NCT00434161|Drug|Placebo|"One bolus IV injection at 60 μg/kg/day of matched placebo on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
~Minimum of 4 days between pre-chemotherapy and post-transplantation dosing."
16328661|NCT00434161|Drug|Palifermin before and after|"One bolus IV injection at 60 μg/kg/day, on Days 6, 5 & 4 (before-high dose chemotherapy) and on Days 0, 1 & 2 (after-high dose chemotherapy).
~Minimum of 4 days between before-chemotherapy and after-transplantation dosing."
16328662|NCT00434148|Drug|Pasireotide|
16328663|NCT00434135|Drug|gemcitabine plus pemetrexed, paclitaxel plus gemcitabine|gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8
16328664|NCT00434122|Drug|Degarelix mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
16328665|NCT00434122|Drug|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
16328666|NCT00434109|Drug|Sunitinib malate|Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations.
16328667|NCT00434109|Procedure|Hepatic Artery Embolizations|1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.
16328668|NCT00434096|Drug|rimonabant (SR141716)|oral administration once daily
16328669|NCT00434096|Drug|placebo|oral administration once daily
16328670|NCT00434083|Drug|sumatriptan|
16328671|NCT00434083|Drug|naproxen sodium|
16328672|NCT00434057|Device|MelaFind(R)|Biopsy ratio comparison
16328673|NCT00434044|Drug|Enbrel (etanercept)|
16328674|NCT00434031|Drug|docetaxel|
16328675|NCT00434031|Drug|cyclophosphamide|
16328676|NCT00434031|Drug|trastuzumab|
16328677|NCT00434031|Drug|liposomal doxorubicin|
16328678|NCT00434018|Behavioral|Wheelchair Skills Training|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
16328679|NCT00434018|Behavioral|Basic Health Education|Five sessions are held with subjects to provide them with educational information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc.
16328680|NCT00434005|Drug|N-acetylcysteine, ascorbate|NAC: 600mg twice daily for the day prior to exposure and 1x pre-exposure Ascorbate: 500mg twice daily for 7 days prior to exposure
16328681|NCT00434005|Drug|Placebo|matched appearance to acetylcysteine and ascorbate intervention
16328682|NCT00433979|Drug|antiretroviral treatment|These antiretroviral drugs are a part of the participant's current drug regimen.
16328683|NCT00433966|Drug|Bivalirudin|Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
16328684|NCT00433966|Drug|Unfractionated heparin|60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
16328685|NCT00433966|Device|Bare metal stent|Uncoated bare metal stent
16328686|NCT00433966|Device|Paclitaxel-eluting stent|slow rate-release paclitaxel-eluting stent
16328687|NCT00433953|Drug|Mycophenolate Mofetil (CellCept)|
16328688|NCT00433953|Behavioral|Dietary Monitoring|
16328689|NCT00433953|Behavioral|Drug Diary|
16328690|NCT00433953|Procedure|Blood Sampling|
16328691|NCT00433940|Drug|Prednisolone|Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.
16328692|NCT00433927|Drug|5-FU|5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
16328693|NCT00433927|Drug|folinic acid|Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
16328694|NCT00433927|Drug|irinotecan|Irinotecan 180 mg/m² iv, 30 - 90 min day 1
16328695|NCT00433927|Drug|cetuximab|Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
16328696|NCT00433927|Drug|bevacizumab|Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1
16328697|NCT00433914|Biological|rMenB|One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
16328698|NCT00433914|Biological|rMenB+OMV|One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
16328699|NCT00433901|Behavioral|Targeted parental instruction for positive lifestyle change with follow-up calls.|
16328700|NCT00433888|Drug|R744|100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
16328701|NCT00433888|Drug|R744|150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
16328702|NCT00433875|Drug|AMG 714|
16328703|NCT00433849|Drug|R744|100μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
16328704|NCT00433849|Drug|R744|150μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
16328705|NCT00433836|Drug|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
16328706|NCT00433836|Drug|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
16328707|NCT00433823|Drug|Atorvastatin, Ezetimibe|
16328708|NCT00433797|Dietary Supplement|Prostate cancer, phytochemical and PUFA|Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
16328709|NCT00433784|Drug|Clopidogrel|
16328712|NCT00433771|Device|WallFlex™ Biliary Fully Covered Metal Stent placement|Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.
16328713|NCT00433758|Device|GlucoTrack|GT
16328714|NCT00433745|Drug|WT1 Peptide Vaccine|WT1 vaccination (9 doses of WT-1:126-134 peptide (in Montanide adjuvant) administered concomitantly with GM-CSF (Sargramostim)
16328715|NCT00433732|Drug|sumatriptan|
16328716|NCT00433732|Drug|naproxen sodium|
16328717|NCT00433719|Drug|Combivir and efavirenz|Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months
16328718|NCT00433706|Procedure|Control position by 3DOBI before the fraction|
16328719|NCT00433706|Procedure|Standard imaging|
16328720|NCT00433693|Drug|R744|50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25~300μg(i.v.)/4 week
16328721|NCT00433680|Behavioral|Healthy Weight|4 weekly 1 hour meetings that encourage reductions in fat and sugar intake and increases in physical activity to decrease onset of obesity and body dissatisfaction.
16328722|NCT00433667|Drug|RWJ-333369|
16328723|NCT00433654|Device|Implantable Pulse Generator (IPG) and Pacing Leads (wires)|Pacer and leads
16328724|NCT00433654|Other|Magnetic Resonance Imaging (MRI) scan|One hour MRI scan on the head and lower back.
16328725|NCT00433641|Drug|sibutramine|placebo
16328726|NCT00433641|Drug|sibutramine|oral 15 mg sibutramine once per day
16328727|NCT00433641|Drug|sibutramine|oral sibutramine 10 mg once per day
16328728|NCT00433615|Drug|R744|100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
16328729|NCT00433615|Drug|R744|150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
16328730|NCT00433602|Other|clinical observation|
16328731|NCT00433602|Procedure|management of therapy complications|
16328732|NCT00433602|Procedure|ultrasound imaging|
16328733|NCT00433589|Drug|anthracycline-based|
16328734|NCT00433589|Drug|docetaxel and capecitabine|
16328735|NCT00433576|Drug|resveratrol|Given orally
16328736|NCT00433576|Other|pharmacological study|Correlative studies
16328737|NCT00433576|Other|laboratory biomarker analysis|Correlative studies
16328738|NCT00433563|Radiation|Once daily radiotherapy|Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
16328739|NCT00433563|Radiation|Twice daily radiotherapy|Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy
16328740|NCT00433550|Drug|capecitabine|given orally
16328741|NCT00433550|Drug|irinotecan hydrochloride|given IV
16328742|NCT00433550|Drug|oxaliplatin|given IV
16328743|NCT00433537|Drug|bortezomib|Given IV
16328744|NCT00433537|Biological|rituximab|Given IV
16328745|NCT00433537|Drug|cyclophosphamide|Given IV
16328746|NCT00433537|Drug|doxorubicin hydrochloride|Given IV
16328747|NCT00433537|Drug|vincristine|Given IV
16328748|NCT00433537|Drug|dexamethasone|Given IV
16328749|NCT00433537|Biological|filgrastim|Given SC
16328750|NCT00433537|Biological|pegfilgrastim|Given SC
16328751|NCT00433537|Procedure|Autologous stem cell transplantation (ASCT)|
16328752|NCT00433524|Procedure|computed tomography|
16328753|NCT00433511|Biological|Bevacizumab|Given IV
16328754|NCT00433511|Drug|Cyclophosphamide|Given IV
16328755|NCT00433511|Drug|Doxorubicin Hydrochloride|Given IV
16328756|NCT00433511|Other|Laboratory Biomarker Analysis|Correlative studies
16328757|NCT00433511|Drug|Paclitaxel|Given IV
16328758|NCT00433511|Other|Placebo Administration|Given IV
16328759|NCT00433511|Other|Quality-of-Life Assessment|Ancillary studies (closed as of 5/28/10)
16328760|NCT00433498|Drug|carboplatin|Should be given according to local practice but suggested doses and schedules are provided in the protocol.
16328761|NCT00433498|Drug|cisplatin|Should be given according to local practice but suggested doses and schedules are provided in the protocol.
16328762|NCT00433498|Drug|etoposide phosphate|Day 1: given by IV, days 2 and 3 given by IV or oral. Dose should be given according to local practice but suggested doses and schedules are provided in the protocol.
16328763|NCT00433498|Drug|pravastatin sodium|40mg daily oral tablet taken for a maximum of 2 years
16328764|NCT00433485|Drug|sirolimus|
16328765|NCT00433485|Genetic|comparative genomic hybridization|
16328766|NCT00433485|Genetic|gene expression analysis|
16328767|NCT00433485|Genetic|microarray analysis|
16328768|NCT00433485|Genetic|protein expression analysis|
16328769|NCT00433485|Genetic|proteomic profiling|
16328770|NCT00433485|Other|laboratory biomarker analysis|
16328771|NCT00433485|Other|mass spectrometry|
16328772|NCT00433485|Procedure|biopsy|
16328773|NCT00433472|Device|magnetic resonance imaging (MRI)|MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
16328774|NCT00433459|Drug|cyclophosphamide|drug is used in first line treatment in combination (COPP or COPDAC)
16328775|NCT00433459|Drug|dacarbazine|drug is used in first line treatment in combination (COPDAC)
16328776|NCT00433459|Drug|prednisolone|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
16328777|NCT00433459|Drug|prednisone|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
16328778|NCT00433459|Drug|procarbazine hydrochloride|drug is used in first line treatment in combination (COPP)
16328779|NCT00433459|Drug|vincristine sulfate|drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
16328780|NCT00433459|Radiation|fludeoxyglucose F 18|used as a diagnostic marker for metabolically active tumour at staging and response assessment
16328781|NCT00433459|Radiation|radiation therapy|part of combination treatment (combined modality between chemo- and radiotherapy)
16328782|NCT00433446|Biological|CNTO 328|
16328783|NCT00433433|Drug|ABVD q4 weeks|Doxorubicin 25 mg/m2 i.v. day 1 and 15; Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15; Vinblastine 6 mg/m2 i.v. day 1 and 15; Dacarbazine 375 mg/m2 i.v. day 1 and 15
16331291|NCT00415077|Procedure|PRK|PRK
16328784|NCT00433433|Drug|BEACOPP escalated q3 weeks|Cyclophosphamide 1250 mg/m2 i.v. day 1; Doxorubicin 35 mg/m2 i.v. day 1; Vincristine 1.4 mg/m2 i.v.(max.2mg) day 8; Bleomycin 10 mg/m2 i.v./i.m. day 8; Etoposide 200 mg/m2/ i.v. day 1 to 3; Procarbazine 100 mg/m2 orally day 1 to 7; Prednisone 40 mg/m2 orally day 1 to 14; G-CSF 5 mcg/kg s.c. day 9 to recovery leukocytes>1.0x109/l
16328785|NCT00433433|Radiation|IN-RT 30 Gy (+ boost 6 Gy residual)|
16328786|NCT00433433|Procedure|FDG-PET scan|
16328787|NCT00433420|Biological|pegfilgrastim|
16328788|NCT00433420|Drug|cyclophosphamide|
16328789|NCT00433420|Drug|epirubicin hydrochloride|
16328790|NCT00433420|Drug|fluorouracil|
16328791|NCT00433420|Drug|paclitaxel|
16328792|NCT00433420|Procedure|adjuvant therapy|
16328793|NCT00433407|Biological|trastuzumab|
16328794|NCT00433394|Procedure|cancer prevention intervention|
16328795|NCT00433394|Procedure|educational intervention|
16328796|NCT00433381|Biological|Bevacizumab|Given IV
16328797|NCT00433381|Drug|Irinotecan Hydrochloride|Given IV
16328798|NCT00433381|Drug|Temozolomide|Given orally
16328799|NCT00433368|Drug|L-Ornithine L-Aspartate|
16328800|NCT00433342|Drug|Flucloxacillin|500 mg QD oral
16328801|NCT00433329|Drug|Bosentan|Oral bosentan 62.5 mg BID first 4 weeks followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated
16328802|NCT00433329|Drug|Sildenafil|Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16
16328803|NCT00433316|Drug|ropivacaine|1% ropivacaine
16328804|NCT00433316|Device|Aeroneb Pro Nezulizer, Aerogen, Ireland|Aeroneb Pro Nezulizer, Aerogen, Ireland
16328805|NCT00433303|Behavioral|Correlation between early delivery and coital activity|
16328806|NCT00433290|Drug|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
16328807|NCT00433290|Drug|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
16328808|NCT00433277|Drug|twice-daily dosage with 0.5% cyclosporine-A eyedrops|
16328809|NCT00433264|Procedure|peritoneal dialysis|individualised
16328810|NCT00433238|Behavioral|Participants will be screened for depression and cognitive impairment, then receive screening results.|
16328811|NCT00433225|Drug|Prednisolone Acetate|
16328812|NCT00433225|Drug|Ketorolac 0.4%|
16328813|NCT00433225|Drug|Gatifloxacin 0.3%|
16328814|NCT00433212|Device|nCPAP|Deliver non-invasive respiratory support via ventilator with nCPAP device
16328815|NCT00433212|Device|NIPPV|Deliver non-invasive respiratory support via ventilator with NIPPV device
16328816|NCT00433199|Drug|Testosterone (T) Gel 1.62%|Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
16328817|NCT00433199|Drug|Placebo|Placebo Control
16328818|NCT00433186|Drug|Mycophenolate Mofetil|Mycophenolate 3000 mg each day
16328819|NCT00433173|Procedure|intravenous glucose tolerance test|The IVGTT (70) is a 4 hour study with baseline sampling for insulin and glucose, followed by the administration of 0.3 mg/kg infusion of glucose, and subsequent frequent samples through 180 minutes. At 20 minutes, subjects will receive a 0.03 U/kg infusion of regular human insulin over 45 seconds to enhance the insulin level to better help us assess the impact of insulin on glucose uptake and to facilitate minimal model analysis. The IVGTT will be administered at baseline and after 3 months.
16328820|NCT00433173|Drug|testosterone|transdermal 7.5 g/per day for 3 months
16328821|NCT00433173|Drug|anastrozole|tablet (per oral) 10.0 mg/ daily 3 months
16328822|NCT00433173|Drug|goserelin acetate implant|single depot injection 10.8 mg 3 months
16328823|NCT00433173|Procedure|aerobic capacity (VO2 Max)|This test is employed to assess VO2max in all subjects. O2 and CO2 will be collected and measured from the expired air during the exercise stress test and used to calculate VO2max. This test will be administered at baseline and after 3 months.
16328824|NCT00433173|Procedure|MRI|1H-MR spectroscopy will be performed to measure IMCL at baseline and after 3 months.
16328825|NCT00433173|Procedure|muscle biopsy|Biopsies (20-50mg) will be obtained from the vastus lateralis muscle under local anesthesia (1% lidocaine) using a 5 mm Bergström needle (65) with suction applied. The muscle biopsy will be performed at baseline and after 3 months.
16328826|NCT00433173|Procedure|measurement of resting metabolic rate (energy expenditure)|Energy expenditure in the form of resting metabolic rate (RMR) will be measured via a metabolic monitor at baseline and after 3 months.
16328827|NCT00433173|Procedure|Dual energy x-ray absorptiometry|Total and regional percent body fat, fat mass, lean tissue mass and bone mineral content will be determined by DEXA (Lunar Prodigy version 8.50). DEXA provides an in vivo assessment of body composition with minimal requirements for subject cooperation and will be employed at baseline and after 3 months.
16328828|NCT00433173|Procedure|Fasting oral glucose tolerance test|To examine glucose and insulin metabolism a standard 75g OGTT will be conducted at baseline and after 3 months.
16328829|NCT00433160|Drug|Teriparatide|daily, subcutaneous
16328830|NCT00433160|Drug|Placebo|daily, subcutaneous
16328831|NCT00433147|Drug|Afegostat tartrate|
16328832|NCT00433134|Behavioral|Adherence|
16328833|NCT00433121|Drug|Risperidone|
16328834|NCT00433121|Drug|Olanzapine|
16328835|NCT00433121|Drug|Haloperidole|
16328836|NCT00433121|Drug|Quetiapin|
16328837|NCT00433121|Drug|Escitalopram|
16328838|NCT00433121|Drug|Citalopram|
16328839|NCT00433121|Drug|Sertralin|
16328840|NCT00433108|Drug|Mitoquinone mesylate (MitoQ)|
16328841|NCT00433095|Drug|Navelbine|
16328842|NCT00433095|Drug|Herceptin|
16328843|NCT00433095|Drug|Navelbine (oraly)|
16328844|NCT00433082|Behavioral|Ramadan Fasting|
16328845|NCT00433069|Drug|Pioglitazone|Increase early virological response to pegylated interferon alpha plus ribavirin by increasing insulin sensitivity
16328846|NCT00433069|Drug|Interferon Alfa-2a|Standard of care for chronic hepatitis C
16328847|NCT00433069|Drug|Ribavirin|Standard of care for chronic hepatitis C
16328848|NCT00433056|Other|STI|CD4 guided treatment interruption
16328849|NCT00433056|Drug|stable HAART|continuous therapy
16328850|NCT00433043|Drug|Beta blocker (carvedilol or metoprolol succinate)|Both groups get CRT. Group 1 is uptitrated to target dose beta blocker after CRT. Group 2 maintains their b-blocker dose from study entry.
16328851|NCT00433043|Procedure|CRT (cardiac resynchronization therapy)|Both arms
16328852|NCT00433017|Drug|Verteporfin Photodynamic Therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of the infusion.
16328853|NCT00433017|Drug|Ranibizumab|Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
16328854|NCT00433017|Drug|Placebo|As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
16328855|NCT00433004|Drug|Plan B (Levonorgestrel)|PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
16328856|NCT00432991|Drug|Ephedrine [Synonyms: Ephedra, Ephedrinum]|25 mg, IM (in the muscle), one time
16328857|NCT00432991|Drug|Saline Placebo|0.5 mL, IM (in the muscle), one time
16328858|NCT00432978|Drug|Bosentan administration|
16328859|NCT00432965|Device|Moist Wound Therapy|Moist Wound Therapy (Standard of Care)
16328860|NCT00432965|Device|VAC Therapy|VAC Therapy
16328861|NCT00432952|Behavioral|Intake of rainbow trout from different feeding conditions versus a control poultry meal|
16328862|NCT00432926|Behavioral|EDGE counseling, no maintenance|Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).
16328863|NCT00432926|Behavioral|EDGE counseling, plus maintenance|Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.
16328864|NCT00432926|Behavioral|Attention control|An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
16328865|NCT00432913|Drug|Eicosapentaenoic Acid (EPA)|Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)
16328866|NCT00432913|Procedure|Endoscopy|At baseline, month 3 and month 6.
16328867|NCT00432913|Procedure|Biopsies taken|9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.
16328868|NCT00432913|Procedure|Clinical chemistry|Full blood count at baseline, month 3 and month 6.
16328869|NCT00432913|Procedure|Haematology|Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
16328870|NCT00432913|Procedure|Physical examination|Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
16328871|NCT00432913|Procedure|Vital signs|Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
16328872|NCT00432913|Procedure|Urine pregnancy test|For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
16328873|NCT00432913|Procedure|Completion of patient diary card|Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.
16328874|NCT00432900|Radiation|[(11)C]PBR28|PET Ligand
16328875|NCT00432887|Drug|caffeine administration|
16328876|NCT00432874|Procedure|wound hydration method|Anterior vs lateral wound hydration
16328877|NCT00432861|Drug|PANCRECARB® (pancrelipase)|Capsules
16328878|NCT00432861|Drug|Placebo|Capsules
16328879|NCT00432835|Device|Gastric Electrical Stimulator, Enterra, Medtronics, Inc.|All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
16328880|NCT00432822|Drug|tetrahydrobiopterin (BH4)|
16328881|NCT00432809|Procedure|Gastric bypass|Roux-en-Y gastric bypass
16328882|NCT00432809|Procedure|Sleeve Gastrectomy|Laparoscopic sleeve gastrectomy
16328883|NCT00432796|Drug|Dalteparin|5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
16328884|NCT00432796|Other|Placebo|"patients will be randomized post-operative to receive either active treatment or placebo.
~the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery.
~ie. 5,000 iu or 200 iu/kg"
16328885|NCT00432770|Drug|ARC1779|
16328886|NCT00432757|Drug|Ketotifen with a Contact Lens (generic name not yet established)|
16328887|NCT00432744|Drug|CoenzymeQ10|CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.
16328888|NCT00432744|Drug|Placebo|Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
16328889|NCT00432731|Biological|VARIVAX®|
16328890|NCT00432731|Biological|M-M-RTM II|
16328891|NCT00432718|Procedure|Saline Instillation before Tracheal Suctioning|
16328892|NCT00432705|Procedure|Checking stability of ankle|Flexing and walking
16328893|NCT00432692|Procedure|Falls Prevention Program|
16328894|NCT00432679|Drug|Rosiglitazone (BRL49653C)|study drug
16328995|NCT00431873|Drug|MGCD0103|MGCD0103 Administered orally three times per week.
16328996|NCT00431860|Procedure|Coronary computed tomographic angiography|
16328997|NCT00431847|Procedure|Regional Anesthesia|Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.
16329122|NCT00430885|Drug|Octagam (IVIG)|Intravenous immunoglobulin 0.4 g/kg given as infusion
16328895|NCT00432666|Drug|IncobotulinumtoxinA (Xeomin)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection"
16328896|NCT00432666|Drug|Placebo|Placebo
16328897|NCT00432653|Drug|rituximab|
16328898|NCT00432640|Procedure|Endoscopic ultrasound staging|Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
16328899|NCT00432640|Procedure|Surgical staging|Surgical staging
16328900|NCT00432627|Drug|Deferasirox|one dose of 20 mg/kg/day
16328901|NCT00432614|Drug|SR58611A|oral administration
16328902|NCT00432614|Drug|escitalopram|oral administration
16328903|NCT00432614|Drug|placebo|oral administration
16328904|NCT00432601|Behavioral|type of decision aid|We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
16328905|NCT00432588|Drug|misoprostol|
16328906|NCT00432588|Drug|dinoprostone|
16328907|NCT00432575|Drug|surinabant (SR147778)|oral administration
16328908|NCT00432575|Drug|placebo|oral administration
16328909|NCT00432562|Drug|Vinorelbine Tartrate|Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.
16328910|NCT00432549|Drug|Almotriptan|
16328911|NCT00432549|Drug|Topiramate|
16328912|NCT00432536|Other|Quality improvement intervention|determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
16328914|NCT00432510|Drug|C1 esterase inhibitor [human] (C1INH-nf)|
16328915|NCT00432484|Drug|Lingzhi and Sen Miao San|G lucidum and SMS were supplied as capsules, containing 4.0 gm of G lucidum extract, 2.4 gm of Rhizoma atractylodis (Cangzhu), 2.4 gm of Cotex phellodendri(Huangbai), and 2.4 gm of Radix achyranthes Bidentatae(Niuxi). Each patient took either 3 capsules twice daily as recommended by the TCM experts or identical-looking placebo.
16328916|NCT00432471|Procedure|Optical Imaging|Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.
16328917|NCT00432458|Drug|Thalidomide|200 mg orally on days 1-28 of 28 day cycle
16328918|NCT00432458|Drug|zoledronic acid|4 mg^2 by IV on day 1 every 84 days for 1 year and once per year thereafter
16328919|NCT00432445|Radiation|Proton Beam Radiation Therapy|Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.
16328920|NCT00432445|Procedure|Ophthalmic EUA|Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)
16328921|NCT00432432|Drug|Infliximab and MTX|MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
16328922|NCT00432419|Procedure|autologous peripheral blood cell transplantation|
16328923|NCT00432406|Drug|Infliximab|Infliximab 5 mg/kg given at day 1, week 2, week 6
16328924|NCT00432406|Drug|Etanercept|Etanercept 25 mg twice weekly
16328925|NCT00432393|Drug|levodopa-carbidopa|
16328926|NCT00432380|Biological|Rotarix™|oral doses
16328927|NCT00432380|Biological|Placebo|oral dose
16328928|NCT00432367|Drug|Amodiaquine plus artesunate combination; sulphadoxine-pyrimethamine|"Eligible women will be allocated randomly to one of three groups and treated as follows:
~Arm 1 (OptiMAL® antigen screening and treatment with SP plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment if her screening test is positive.
~Arm 2 (OptiMAL® antigen screening and treatment with AQ+AS plus LLIN) - a woman in this will receive 300mg of AQ and 100mg co-administered two times a day for 3 days if her screening test is positive. The first dose is observed on enrolment day at the ANC.
~Arm 3 (SP-IPTp plus LLIN group) - a woman in this will receive 1500mg/75mg (S/P) administered at the ANC as single dose on enrollment as recommended by national policy.
~All enrolled women will be given one long lasting insecticide treated bed net each for use."
16328929|NCT00432354|Drug|atorvastatin|
16328930|NCT00432341|Biological|botulinum toxin type A|200 Units at Visit 1 (Day 1)
16328931|NCT00432341|Biological|botulinum toxin type A|500 Units at Visit 1 (Day 1)
16328932|NCT00432328|Drug|Avotermin|
16328933|NCT00432315|Drug|Docetaxel + CDDP|"3 cycles chemotherapy : docetaxel + CDDP
~Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered)
~3 cycles adjuvant chemotherapy docetaxel"
16328934|NCT00432315|Drug|docetaxel + CDDP|"3 cycles chemotherapy: docetaxel + CDDP
~Radiochemotherapy
~3 cycles adjuvant chemotherapy docetaxel"
16328935|NCT00432302|Drug|Sagopilone (BAY 86-5302, ZK 219477)|First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.
16328936|NCT00432289|Procedure|Acupuncture|Acupunture treatment 3x per week for 6 weeks.
16328937|NCT00432276|Drug|Alogliptin|Alogliptin tablets.
16328938|NCT00432276|Drug|Pioglitazone|Pioglitazone tablets.
16328939|NCT00432276|Drug|Metformin|Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose.
16328940|NCT00432276|Drug|Placebo|Matching placebo tablets.
16328941|NCT00432263|Drug|Genotropin (PN-180,307) Somatropin|
16328942|NCT00432250|Procedure|Cervical length ultrasound|
16328943|NCT00432237|Drug|MK0974 50 mg|
16328944|NCT00432237|Drug|MK0974 150 mg|
16328945|NCT00432237|Drug|MK0974 300 mg|
16328946|NCT00432237|Drug|Comparator: Placebo|MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
16328947|NCT00432224|Procedure|photodynamic therapy|
16329119|NCT00430924|Drug|Eplerenone|Once daily administration for 8 weeks and 8 weeks control.
16328948|NCT00432211|Drug|Avotermin|"Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration.
~Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration."
16328949|NCT00432198|Drug|Zolpidem (Myslee®)|Oral
16328950|NCT00432198|Drug|placebo|Oral
16328951|NCT00432185|Drug|PEP005|0.25% PEP005 Gel
16328952|NCT00432172|Drug|Epirubicin|
16328953|NCT00432172|Drug|Cyclophosphamide|
16328954|NCT00432172|Drug|Docetaxel|
16328955|NCT00432172|Drug|Exemestane|
16328956|NCT00432172|Drug|Goserelin|
16328957|NCT00432172|Drug|Carboplatin|
16328958|NCT00432159|Device|Cervical TDR|Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
16328959|NCT00432159|Device|ACDF with plate|Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
16328960|NCT00432146|Drug|lugol's solution|
16328961|NCT00432133|Behavioral|Protection Motivation Theory-Based Intervention|Targets perceptions of outcome severity and susceptibility, self-efficacy, response efficacy, response costs, and rewards of physical inactivity. One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
16328962|NCT00432133|Behavioral|Environmenta|Targets increased awareness and use of local parks and trials near the home and work environments. Targets increased access by providing membership to a local fitness facility for 12 months. One computer interactive session is followed by 3 automated telephone counseling sessions and 4 tailored newletters spread over a 6 month period.
16328963|NCT00432120|Drug|clopidogrel|To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention
16328964|NCT00432107|Drug|APO866|APO866 is administered as 0.126 mg/m²/hr IV every 4 weeks for 4 consecutive days (96 hours) for a total of 3 cycles
16328965|NCT00432094|Drug|carboplatin|Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes
16328966|NCT00432094|Drug|etoposide|600mg/m^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
16328967|NCT00432094|Drug|ifosfamide|2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
16328968|NCT00432094|Drug|paclitaxel|225 mg/m^2 intravenous over 3 hours on Day -7.
16328969|NCT00432094|Drug|thiotepa|150mg/m^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
16328970|NCT00432094|Procedure|autologous hematopoietic stem cell transplantation|Peripheral blood stem cell infusion (< 4 x 10^6 CD34+ cells/kg)
16328971|NCT00432094|Drug|Mesna|2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
16328972|NCT00432094|Biological|filgrastim|Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
16328973|NCT00432081|Drug|indomethacin|
16328974|NCT00432068|Drug|Octreotide pamoate|
16328975|NCT00432055|Drug|Botulinum toxin type A (Botox)|
16328976|NCT00432055|Drug|placebo (saline)|
16328977|NCT00432042|Biological|ProQuad®|Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose [CCID]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units [PFU]).
16328978|NCT00432042|Biological|Infanrix® hexa|Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).
16328979|NCT00432029|Procedure|Forearm blood flow measurement, Flow mediated dilation (FMD)|Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
16328980|NCT00432029|Device|Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light|Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
16328981|NCT00432016|Drug|zidovudine|
16328982|NCT00432016|Drug|amdoxovir|
16328983|NCT00432016|Procedure|pharmacokinetic sampling|
16328984|NCT00431990|Drug|depsipeptide|Cohort 1. Dose escalation, IV, Weeklyx3 in a 4week cycle. Cohort 2A. 12mg/m2, IV, Weeklyx3 in a 4week cycle. Cohort 2B. 12mg/m2, IV, Weeklyx2 in a 3week cycle.
16328985|NCT00431990|Drug|bortezomib|Cohort 1 and 2A. 3.5mg/m2, IV, day 1, 4, 8, 11 in 28 day cycle. Cohort 2B. 3.5mg/m2, IV, day 1, 4, 8, 11 in 21 day cycle
16328986|NCT00431990|Drug|dexamethasone|20mg for 2 days with each dose of bortezomib
16328987|NCT00431977|Procedure|coronary computed tomography angiography|
16328988|NCT00431964|Drug|azithromycin 250 mg tablets|"One (1) tablet three times weekly for patients who weigh 40-79 lbs
~Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
16328989|NCT00431964|Drug|placebo tablets|"One (1) tablet three times weekly for patients who weigh 40-79 lbs
~Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
16328990|NCT00431951|Drug|ST-246|250 mg, 400 mg or 800 mg capsules given once daily for 21 days
16328991|NCT00431951|Drug|Placebo|Capsules to match experimental drug
16328992|NCT00431912|Drug|APO866|APO866 is administered as 0.126 mg/m²/hr for 4 consecutive days (96 hours), every 3 weeks for a total of 3 cycles
16328993|NCT00431899|Behavioral|fish oil supplementation|
16328994|NCT00431886|Procedure|64 multi-detector computed tomography|
16328998|NCT00431847|Procedure|Standard Pain Management Protocol|Intermittent dosing of analgesics and anxiolytics instituted prior to continuous intravenously dosing which was individually titrated to patient care goals.
16328999|NCT00431834|Device|Cardioblate System Surgical Ablation System|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
16329000|NCT00431834|Procedure|Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
16329001|NCT00431821|Behavioral|Exercise|Home-based exercise prescriptions with weekly motivational telephone calls.
16329002|NCT00431821|Other|Stroke education|Stroke education program with matched attention phone calls
16329003|NCT00431808|Biological|Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]|3 doses of AMA 1 vaccine
16329004|NCT00431808|Biological|AMA1|50 micrograms of AMA1
16329005|NCT00431795|Drug|Pegylated liposomal doxorubicin (Caelyx)|Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
16329006|NCT00431795|Drug|Epirubicin|Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
16329007|NCT00431782|Drug|ATI-5923|
16329008|NCT00431769|Drug|Bortezomib|Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).
16329009|NCT00431743|Drug|Hydroxyethylstarch 130/0,4|
16329010|NCT00431743|Drug|Lactated Ringer's solution|
16329011|NCT00431730|Procedure|flicker light stimulation|
16329012|NCT00431704|Drug|vinorelbine|25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
16329013|NCT00431704|Drug|carboplatin|AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
16329014|NCT00431704|Drug|trastuzumab|8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
16329015|NCT00431691|Drug|vitamin and mineral supplement|"dose: 4 tablets daily for two weeks
~vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg"
16329016|NCT00431691|Drug|Escherichia coli Endotoxin (LPS)|dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
16329017|NCT00431691|Drug|100% O2|breathing for 30 minutes, 2 breathing periods on both study days
16329018|NCT00431691|Drug|nitroglycerin|dose: 0,8 mg sublingual, applied during FMD measurements on both study days
16329019|NCT00431678|Drug|Avelox (Moxifloxacin, BAY12-8039)|Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
16329020|NCT00431678|Drug|Levofloxacin + Ceftriaxone|Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).
16329021|NCT00431665|Drug|NG-monomethyl-L-Arginine (L-NMMA)|
16329022|NCT00431665|Drug|triglycerides (Intralipid 20%)|
16329023|NCT00431665|Drug|heparin|
16329024|NCT00431665|Drug|somatostatin|
16329025|NCT00431665|Drug|insulin|
16329026|NCT00431665|Drug|glucose|
16329027|NCT00431665|Drug|inulin|
16329028|NCT00431665|Drug|paraamino hippurate (PAH)|
16329029|NCT00431639|Behavioral|Animal Assisted Therapy|Every subject will be exposed to both treatment and comparison conditions.
16329030|NCT00431626|Drug|Dutasteride (Avodart)|
16329031|NCT00431626|Drug|Placebo|Placebo before and after treatment of TURP
16329032|NCT00431613|Drug|Docetaxel|Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
16329033|NCT00431613|Drug|Gemcitabine|Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
16329034|NCT00431613|Drug|Carboplatin|Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
16329035|NCT00431613|Radiation|Chemoradiotherapy|"After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy.
~During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32"
16329036|NCT00431613|Drug|Docetaxel|Docetaxel 75mg/m2 IV on day 1 for 3 cycles
16329037|NCT00431600|Other|100% Oxygen|100% Oxygen- breathing over 30 minutes
16329038|NCT00431574|Procedure|dosing|
16329039|NCT00431561|Drug|AP 12009 10 µM|10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
16329040|NCT00431561|Drug|AP 12009 80 µM|80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
16329041|NCT00431561|Drug|temozolomide or PCV|temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen
16329042|NCT00431561|Device|Drug delivery system for administration of AP 12009|Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.
16329043|NCT00431561|Procedure|Placement of Drug Delivery System|Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
16329044|NCT00431548|Drug|100% O2|
16329045|NCT00431522|Drug|Valproic acid, sodium salt|
16329046|NCT00431509|Procedure|conventional vs. navigated total knee arthroplasty|
16329047|NCT00431496|Drug|Cinacalcet|Cinacalcet tablets
16329120|NCT00430911|Drug|Radiotherapy|
16329048|NCT00431483|Behavioral|pharmaceutical consulting|to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials
16329049|NCT00431470|Behavioral|Six classroom based character building education lessons|
16329050|NCT00431457|Device|Implantation of an intracranial electrode|Implantation of an intracranial electrode will be followed.
16329051|NCT00431457|Procedure|amygddohyppocampertomy|Resective surgery
16329052|NCT00431444|Drug|Raloxifene|
16329053|NCT00431444|Drug|Zoledronic acid|
16329054|NCT00431444|Drug|Placebo oral pills|
16329055|NCT00431444|Drug|Placebo intravenous (i.v.) infusion|
16329056|NCT00431431|Drug|tibolone|2 years treatment with tibolone (1.25 mg Org OD-14)
16329057|NCT00431431|Drug|raloxifen|2 years treatment with raloxifene (60 mg)
16329058|NCT00431418|Drug|Sildenafil|Sildenafil oral solution
16329059|NCT00431418|Drug|Placebo|Placebo solution
16329060|NCT00431392|Drug|Phenylephrine|
16329061|NCT00431392|Drug|NG-Monomethyl-L-Arginine|
16329062|NCT00431392|Drug|Propanolol|
16329063|NCT00431392|Drug|Atropine|
16329064|NCT00431379|Drug|Tenecteplase|
16329065|NCT00431353|Drug|Ganciclovir|5mg/kg iv bid for 21 days
16329066|NCT00431353|Drug|valganciclovir [Valcyte]|900mg po bid for 21 days
16329067|NCT00431340|Drug|PXD101|
16329068|NCT00431327|Behavioral|Peer coach phone call|
16329069|NCT00431288|Behavioral|diet high in fruits, vegetables, and dairy|
16329070|NCT00431288|Behavioral|Routine nutrition care|
16329071|NCT00431275|Drug|CP-675,206|CP-675,206 15 mg/kg iv single dose on Day 1
16329072|NCT00431275|Drug|CP-675,206|CP-675,206 15 mg/kg iv single dose on Day 1
16329073|NCT00431262|Drug|antabuse (disulfiram)|
16329074|NCT00431249|Drug|Cilostazol|
16329075|NCT00431236|Drug|Oral Casopitant (GW679769)|
16329076|NCT00431236|Drug|IV Casopitant (GW679769)|
16329077|NCT00431236|Drug|IV ondansetron hydrochloride|
16329078|NCT00431236|Drug|Oral dexamethasone|
16329079|NCT00431223|Behavioral|Cognitive remediation therapy|36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.
16329080|NCT00431210|Biological|Epstein-Barr virus-specific adoptive T-cells immunotherapy|Given intravenously on Day 1 and Day 14
16329081|NCT00431197|Drug|Ketoconazole, Dexamethesone, Androgel,GnRH|
16329082|NCT00431184|Drug|Pentazocine|see arms description
16329083|NCT00431184|Drug|Lorazepam|see arms description
16329084|NCT00431171|Drug|Lithium carbonate|
16329085|NCT00431158|Other|Different Mechanical Ventilation Protocols|"OLA Group: Open lung approach protocol and recruitment maneuvers
~ARDSnet Group: ARDSnet protocol"
16329086|NCT00431145|Drug|Niacin|
16329087|NCT00431145|Drug|Niacin+Statin|
16329088|NCT00431132|Drug|estradiol, 10 mcg|Tablets, administered intravaginally twice weekly
16329089|NCT00431119|Drug|Azathioprine or Mycophenolate mofetil|
16329090|NCT00431106|Drug|Gemcitabine|Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
16329091|NCT00431106|Drug|Capecitabine|Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
16329092|NCT00431106|Drug|Vinorelbine|Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
16329093|NCT00431093|Drug|tibolone|uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).
16329094|NCT00431093|Drug|low-dose estradiol/noresterone|"Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.
~Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time)."
16329095|NCT00431080|Drug|Docetaxel|Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
16329096|NCT00431080|Drug|Paclitaxel|Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
16329097|NCT00431080|Drug|Epirubicin|Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
16329098|NCT00431080|Drug|Cyclophosphamide|Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
16329099|NCT00431080|Drug|5-fluoruracil|5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
16329100|NCT00431080|Drug|Granulocyte-colony stimulating growth factor|rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
16329101|NCT00431067|Drug|BIBW 2992|
16329102|NCT00431054|Drug|Perifosine|Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily
16329103|NCT00431054|Drug|Docetaxel|75 mg/m^2 by vein over 1 hour every 4 weeks
16329104|NCT00431041|Drug|solifenacin|Oral
16329105|NCT00431041|Drug|oxybutynin immediate release|Oral
16329106|NCT00431028|Device|slow delivery ciprofloxacin + triamcinolone|2 mg ciprofloxacin + 25mg triamcinolone
16329107|NCT00431015|Drug|IPI-504|IV Hsp90 inhibitor
16329108|NCT00431002|Behavioral|Resistance training|See Detailed Description.
16329109|NCT00430989|Other|Nitrous Oxide|General anaesthesia with the inclusion of Nitrous Oxide at 70%
16329110|NCT00430989|Other|No Nitrous Oxide|General anaesthesia with no use of Nitrous Oxide
16329111|NCT00430976|Behavioral|Minds in Motion|
16329112|NCT00430963|Drug|IncobotulinumtoxinA (Xeomin) (20 Units)|
16329113|NCT00430963|Drug|Placebo|
16329114|NCT00430950|Drug|olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets|olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
16329115|NCT00430950|Drug|olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
16329116|NCT00430937|Drug|Daptomycin|4 mg/kg intravenous once daily
16329117|NCT00430937|Drug|Vancomycin|1 g intravenous twice daily
16329118|NCT00430937|Drug|Teicoplanin|400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
16329374|NCT00429104|Drug|GM-CSF|250 mcg/m^2 Subcutaneously
16329123|NCT00430872|Behavioral|Survey|Survey about the severity of certain symptoms lasting 10-15 minutes.
16329124|NCT00430859|Drug|Alkaline Phosphatase|Intravenous over a period of 24 hours
16329125|NCT00430859|Drug|Placebo|Saline over a period of 24h
16329126|NCT00430846|Drug|SGN-35|Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
16329127|NCT00430833|Drug|candesartan|
16329128|NCT00430820|Procedure|per intervention|per intervention
16329129|NCT00430807|Drug|hydroxychloroquine/placebo|
16329130|NCT00430794|Drug|Spironolactone|
16329131|NCT00430781|Drug|pazopanib (GW786034)|
16329132|NCT00430781|Drug|lapatinib (GW572016)|
16329133|NCT00430768|Biological|rAAV1-CB-hAAT|
16329134|NCT00430755|Device|Computer-assisted history|"Methods The intervention was use of an expert system to acquire medical histories by direct interview of patients.
~Description of the software program - The program tested in this study consisted of a data acquisition [history-taking] component and a data analysis component. The data acquisition component was constructed on the basis of established principles of pathophysiology. Medical knowledge was formalized as software algorithms that were machine-readable by representing the knowledge as branched chain decision trees."
16329135|NCT00430755|Procedure|physician taken history|Convential history taking by physicians
16329136|NCT00430755|Other|Computer-assisted history taking|
16329137|NCT00430742|Drug|Taranabant|Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
16329138|NCT00430742|Drug|Comparator: Placebo|Placebo capsule once daily. Treatment for 52 weeks.
16329139|NCT00430729|Drug|Roflumilast|
16329140|NCT00430716|Drug|Sildenafil citrate|oral, 20 mg, tid
16329141|NCT00430716|Drug|Sildenafil citrate|oral 1 mg, tid
16329142|NCT00430716|Drug|Sildenafil citrate|oral 5 mg, tid
16329143|NCT00430716|Drug|Sildenafil citrate|oral 20 mg, tid
16329144|NCT00430703|Behavioral|body weight support treadmill training|Gait training: Gait robot (Lokomat®, Hocoma, Switzerland) is adjusted to the patient/healthy volunteer individually with chest strap, pelvic straps, harness, leg cuffs and foot lifters. Weight is adjusted individually, so there is a minimum weight support (i.e. when one foot is standing on the treadmill the other foot lifts free from the treadmill thereby simulating normal gait). Gait speed is 1,7-2,3 km/hour (speed can be changed and adjusted that the normal step length is achieved).The duration of the training session is 20 minutes.Blood pressure and pulse are monitored.
16329145|NCT00430690|Procedure|acoustic startle testing|acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
16329146|NCT00430677|Drug|Corticosteroids (prednisone or prednisolone)|tablets, oral, 0.5-0.8 mg/kg, daily
16329147|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 30 mg/kg, every 28 days
16329148|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 10 mg/kg, every 28 days
16329149|NCT00430677|Drug|Mycophenolate mofetil (MMF)|tablets, oral, 1.5 to 2 g, daily
16329150|NCT00430677|Drug|Abatacept|intravenous solution, injectable, 10 mg/kg, every 28 days
16329151|NCT00430664|Procedure|Pleurodesis with either talc or iodopovidone|
16329152|NCT00430651|Drug|Docetaxel|Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
16329153|NCT00430651|Drug|Carboplatin|Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
16329154|NCT00430638|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary|olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
16329155|NCT00430638|Drug|Placebo|Oral tablets administered for once daily for 12 weeks
16329156|NCT00430625|Biological|VPRIV ®,|Intravenous (IV) infusion, every other week via intravenous infusion for 12 months
16329157|NCT00430586|Drug|Botulinum neurotoxin type A, free of complexing proteins|Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
16329158|NCT00430586|Drug|Placebo|Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
16329159|NCT00430573|Drug|D-cycloserine|Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
16329160|NCT00430573|Drug|Placebo|Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
16329161|NCT00430560|Behavioral|cognitive rehabilitation|computer training
16329162|NCT00430560|Procedure|work therapy|opportunity to work in carefully supervised hospital job
16329163|NCT00430560|Behavioral|work therapy|work therapy
16329164|NCT00430547|Drug|Carbimazole, radio-active iodine (I131)|
16329165|NCT00430534|Biological|EBV vaccine (268664)|
16329166|NCT00430521|Biological|Pandemic influenza vaccine (GSK1119711A)-formulation 1|2 or 3 doses, intramuscular injection, at different time points.
16329167|NCT00430521|Biological|Pandemic influenza vaccine (GSK1119711A)-formulation 2|2 or 3 doses, intramuscular injection, at different time points.
16329168|NCT00430508|Drug|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
16329169|NCT00430508|Drug|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
16329170|NCT00430508|Drug|olmesartan medoxomil/hydrochlorothiazide tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
16329171|NCT00430508|Drug|olmesartan medoxomil/hydrochlorothiazide tablets|olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
16329245|NCT00430027|Drug|Oxaliplatin|Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
16329172|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
16329173|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
16329174|NCT00430495|Drug|Atacicept|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
16329175|NCT00430495|Drug|Placebo matched to atacicept|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
16329176|NCT00430482|Behavioral|Cognitive Behavioral Therapy|12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
16329177|NCT00430482|Behavioral|Individual Counseling|12 weekly sessions and 3 booster sessions of individual counseling
16329178|NCT00430469|Drug|human lactoferrin (hLF1-11)|intravenous 0.5mg in NaCl-solution
16329179|NCT00430456|Procedure|Exercise|Treadmill Training
16329180|NCT00430443|Drug|Liposomal Annamycin|3-day IV infusion
16329181|NCT00430430|Procedure|High MUFA dietary portfolio|high monounsaturated fat background diet to dietary portfolio
16329182|NCT00430430|Procedure|Low MUFA dietary portfolio|low monounsaturated fat background diet to dietary portfolio
16329183|NCT00430404|Other|Collaborative care (Intervention)|Structured shared care with treatment protocol & support
16329184|NCT00430391|Other|DVD Consent|Participants are randomized to DVD enhanced consent that is either high risk or low risk.
16329185|NCT00430391|Other|Routine Control|Participants are assigned to the routine, standard consent.
16329186|NCT00430378|Procedure|Acupuncture|Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.
16329187|NCT00430378|Other|Standard Care|No Acupuncture.
16329188|NCT00430365|Drug|lenalidomide|oral drug
16329189|NCT00430365|Drug|placebo|oral placebo
16329190|NCT00430352|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv every 8 weeks
16329191|NCT00430326|Drug|Avotermin|
16329192|NCT00430313|Procedure|Electro-Stimulation of Yongquan (K1) Acupoint|Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
16329193|NCT00430313|Procedure|Electro-Stimulation of Yongquan (K1) Acupoint|"Electro-stimulation at a inactive site on the bottom of the foot (a placebo site)."
16329194|NCT00430300|Drug|UK-432,097|Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
16329195|NCT00430300|Drug|Placebo|Capsules containing 100% lactose administered BID using an atomizer device
16329196|NCT00430261|Drug|sunitinib|50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
16329197|NCT00430248|Drug|Febuxostat|Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
16329198|NCT00430248|Drug|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
16329199|NCT00430248|Drug|Allopurinol|"Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.
~Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily."
16329200|NCT00430235|Drug|BAY 43-9006|BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)
16329201|NCT00430196|Drug|BOTOX®|
16329202|NCT00430196|Drug|Zanaflex®|
16329203|NCT00430183|Drug|docetaxel|75 mg/m^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days
16329204|NCT00430183|Drug|LHRH agonist|Given intramuscularly
16329205|NCT00430183|Procedure|surgery|Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
16329206|NCT00430170|Drug|Dipyridamole|Dipyridamole 2x200mg 7day per os
16329207|NCT00430170|Drug|caffeine|caffeine 4mg/kg iv
16329208|NCT00430157|Drug|GSK256066|
16329209|NCT00430144|Drug|Belotecan(CKD-602)|Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
16329210|NCT00430131|Procedure|Cognitive Orientation to Occupational Performance|
16329211|NCT00430131|Procedure|Contemporary Treatment Approach|
16329212|NCT00430118|Drug|asparaginase|
16329213|NCT00430118|Drug|cyclophosphamide|
16329214|NCT00430118|Drug|cytarabine|
16329215|NCT00430118|Drug|daunorubicin hydrochloride|
16329216|NCT00430118|Drug|dexamethasone|
16329217|NCT00430118|Drug|doxorubicin hydrochloride|
16329218|NCT00430118|Drug|etoposide|
16329219|NCT00430118|Drug|ifosfamide|
16329220|NCT00430118|Drug|mercaptopurine|
16329221|NCT00430118|Drug|methotrexate|
16329222|NCT00430118|Drug|prednisone|
16329223|NCT00430118|Drug|thioguanine|
16329224|NCT00430118|Drug|vincristine sulfate|
16329225|NCT00430118|Drug|vindesine|
16329226|NCT00430118|Radiation|radiation therapy|
16329227|NCT00430105|Drug|cyclophosphamide|
16329228|NCT00430092|Drug|Difluprednate|
16329229|NCT00430092|Drug|Difluprednate|
16329230|NCT00430092|Drug|Placebo|
16329231|NCT00430079|Drug|etanidazole|Given IV
16329232|NCT00430079|Procedure|conventional surgery|Undergo surgery
16329233|NCT00430079|Other|pharmacological study|Correlative studies
16329234|NCT00430079|Other|laboratory biomarker analysis|Correlative studies
16329235|NCT00430066|Drug|Imatinib Mesylate|400 mg/die for 6 months
16329236|NCT00430053|Genetic|gene rearrangement analysis|
16329237|NCT00430053|Genetic|polymerase chain reaction|
16329238|NCT00430053|Genetic|proteomic profiling|
16329239|NCT00430053|Other|flow cytometry|
16329240|NCT00430053|Other|immunohistochemistry staining method|
16329241|NCT00430053|Procedure|biopsy|
16329242|NCT00430040|Drug|carvedilol|carvedilol
16329243|NCT00430040|Drug|lisinopril|lisinopril
16329244|NCT00430027|Drug|Capecitabine|Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
16329246|NCT00430027|Drug|Cetuximab|Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
16329247|NCT00430014|Drug|Atiprimod|Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.
16329248|NCT00430001|Drug|docetaxel|
16329249|NCT00430001|Drug|vinorelbine|
16329250|NCT00430001|Drug|trastuzumab|
16329251|NCT00429988|Genetic|fluorescence in situ hybridization|
16329252|NCT00429988|Genetic|polymerase chain reaction|
16329253|NCT00429988|Genetic|proteomic profiling|
16329254|NCT00429988|Other|cytology specimen collection procedure|
16329255|NCT00429988|Other|immunohistochemistry staining method|
16329256|NCT00429988|Procedure|breast duct lavage|
16329257|NCT00429975|Drug|levofloxacin|
16329258|NCT00429975|Drug|ceftriaxone|
16329259|NCT00429962|Drug|intravitreal ranibizumab|intraocular injection
16329260|NCT00429962|Drug|intravitreal ranibizumab & photodynamic therapy|intraocular injection photodynamic treatment (LASER) after intravenous injection
16329261|NCT00429949|Drug|Dasatinib|
16329262|NCT00429936|Drug|Fenretinide|Once daily 30 minutes after the evening meal for 24 months
16329263|NCT00429923|Drug|Difluprednate|
16329264|NCT00429923|Drug|Difluprednate|
16329265|NCT00429923|Drug|Placebo|
16329266|NCT00429897|Drug|Bendroflumethiazide 2.5mg - 5mg|
16329267|NCT00429897|Drug|Amiloride 20-40mg|
16329268|NCT00429897|Drug|Spironolactone 50-100mg|
16329269|NCT00429897|Drug|Frusemide 20-40mg|
16329270|NCT00429897|Drug|Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined|
16329271|NCT00429871|Drug|Docetaxel|Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
16329272|NCT00429871|Drug|Capecitabine|Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
16329273|NCT00429871|Drug|Epirubicin|Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
16329274|NCT00429871|Drug|Docetaxel|Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
16329275|NCT00429858|Drug|S-1|S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
16329276|NCT00429858|Drug|gemcitabine hydrochloride|Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
16329277|NCT00429845|Behavioral|Nutritional|
16329278|NCT00429832|Drug|Ondansetron|
16329279|NCT00429832|Drug|promethazine|
16329280|NCT00429806|Drug|DHEA|DHEA
16329281|NCT00429806|Drug|Placebo|Placebo
16329282|NCT00429793|Drug|temsirolimus|Given IV
16329283|NCT00429780|Biological|Alum-ALM + BCG|Alum-ALM + BCG 200 ug per injection
16329284|NCT00429754|Drug|Aprepitant|
16329285|NCT00429728|Drug|GW876008|
16329286|NCT00429715|Biological|Alum-ALM + BCG|Alum precipitated autoclaved L. major
16329287|NCT00429715|Biological|Alum-ALM + BCG|Arm 1=Alum-ALM + BCG Arm 2=BCG Arm 3=Placebo comparator
16329288|NCT00429715|Biological|Alum-ALM + BCG|Alum-ALM + BCG
16329289|NCT00429702|Drug|Decadron®|Given IV
16329290|NCT00429702|Drug|Benadryl®|Given IV
16329291|NCT00429702|Drug|Ativan®|Given IV
16329292|NCT00429702|Drug|ondansetron hydrochloride|Given IV
16329293|NCT00429689|Procedure|Saliva sample|
16329294|NCT00429676|Drug|Haloperidol|
16329295|NCT00429663|Device|reamed, interlocking intramedullary nail|Standard of care device for femur fracture repair
16329296|NCT00429663|Device|locking periarticular plate|Standard of care device for femur fractures
16329297|NCT00429650|Behavioral|increased exercise|Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
16329298|NCT00429650|Behavioral|diet|Use a prescribed diet to maintain weight loss
16329299|NCT00429650|Behavioral|Exercise and Diet|Use a combination of exercise and diet to maintain weight loss.
16329300|NCT00429624|Procedure|Chiropractic manipulation|
16329301|NCT00429624|Drug|acetaminophen|
16329302|NCT00429611|Procedure|Cardiac defibrillation at high energy vs low energy levels|Defibrillation with progressive high-energy biphasic shocks at 200J, 300J and 360J or low-energy biphasic shocks at 150J, 150J and 150J.
16329303|NCT00429585|Device|reamed, interlocking intramedullary nail|Standard of care device for tibia fracture repair; Randomized Treatment - Nail
16329304|NCT00429585|Device|locking periarticular plate|Standard of care device for tibia fracture repair; Randomized Treatment - Plate
16329305|NCT00429572|Drug|Fludarabine|30 mg/m^2 intravenously Daily for 5 Days
16329306|NCT00429572|Drug|Melphalan|70 mg/m^2 intravenously Daily for 2 Days
16329307|NCT00429572|Procedure|Stem Cell Infusion|Stem Cell Infusion on Day 0.
16329308|NCT00429559|Drug|Hycamptin|1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
16329309|NCT00429559|Drug|Gemcitabine|"Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
~Number of cycles: until progression"
16329310|NCT00429546|Behavioral|Teaching, Raising, and Communicating with Kids (TRACK)|TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.
16329311|NCT00429546|Other|Treatment as usual|Treatment as usual includes standard care for HIV infected mothers.
16329312|NCT00429533|Drug|Dapsone|
16329313|NCT00429520|Drug|Hyaluronic acid filler/IMD1 basic|
16329314|NCT00429507|Drug|153 Sm-EDTMP|Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
16329315|NCT00429507|Behavioral|Questionnaire|Questionnaires taking about 15 minutes to complete.
16329316|NCT00429507|Procedure|Stem Cell Transplant|Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
16329317|NCT00429494|Drug|Leuprolide Acetate|22.5 mg IM injection 2 months before transplant and 3 months post-transplant.
16329318|NCT00429494|Behavioral|Questionnaire|Questionnaires taking about 15 minutes to complete.
16329319|NCT00429494|Procedure|Hematopoietic Stem Cell Transplantation|Stem cell infusion on Day 0.
16329320|NCT00429481|Biological|Rotarix|
16329321|NCT00429468|Drug|Vicodin® CR (extended-release hydrocodone/acetaminophen)|
16329322|NCT00429455|Behavioral|Survey|3-Part Questionnaire
16329323|NCT00429442|Drug|Simvastatin|80 mg once daily
16329324|NCT00429442|Drug|placebo|calcium tablets once daily
16329325|NCT00429429|Procedure|Sublingual immunotherapy|Drops of peanut protein placed and held under the tongue for a specific time before swallowed.
16329326|NCT00429416|Drug|L-leucyl-L-leucine Methyl Ester (LLME)|Infusion of L-leucyl-L-leucine methyl ester (LLME) treated donor white blood cells
16329327|NCT00429416|Drug|Fludarabine|Fludarabine 30 mg/m2 prior to HSCT infusion
16329328|NCT00429416|Drug|Cytarabine|Cytarabine 2gm/m2 prior to HSCT infusion
16329329|NCT00429416|Drug|Cyclophosphamide|Cyclophosphamide 1gm/m2 prior to HSCT infusion
16329330|NCT00429416|Drug|Tacrolimus|Tacrolimus given before and after HSCT infusion
16329331|NCT00429416|Drug|Mesna|Mesna 1gm/m2/day given prior to HSCT infusion.
16329332|NCT00429416|Biological|Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)|GM-CSF given post HSCT infusion
16329333|NCT00429416|Procedure|Hematopoietic stem cell transplantation (HSCT)|CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells
16329334|NCT00429403|Drug|Goserelin|3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
16329335|NCT00429390|Behavioral|Ramadan Fasting|
16329336|NCT00429377|Drug|tacrolimus|
16329337|NCT00429364|Drug|Losartan Potassium|Losartan .3 - 1.4 mg/kg
16329338|NCT00429364|Drug|Atenolol|Atenolol .5 - 4 mg/kg
16329339|NCT00429338|Procedure|AIR-MRSI|3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI).
16329340|NCT00429338|Procedure|PFC-MRSI|3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI).
16329341|NCT00429312|Biological|JX-594|Thymidine kinase-deleted vaccinia virus plus GM-CSF
16329342|NCT00429299|Drug|lapatinib|Arm B 1250mg/d PO Arm C 750mg/d PO
16329343|NCT00429299|Biological|trastuzumab|First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
16329344|NCT00429299|Drug|paclitaxel|80mg/sqm 1 hour infusion for 12 weeks
16329345|NCT00429299|Drug|fluorouracil|600mg/sqm iv day 1 q21 days for four coursess
16329346|NCT00429299|Drug|epidoxorubicin|75mg/sqm iv day 1 q21 days for four courses
16329347|NCT00429299|Drug|cyclophosphamide|600mg/sqm day 1 q21 days for four courses
16329348|NCT00429286|Behavioral|Problem Solving Training|A systematic cognitive-behavioral intervention teaching problem solving skills for addressing functional impairment related to breast cancer and its treatment.
16329349|NCT00429273|Drug|Guanfacine|Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures
16329350|NCT00429273|Drug|Methylphenidate (MPH)|Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
16329351|NCT00429260|Drug|Saredutant|
16329352|NCT00429247|Drug|Trastuzumab|Trastuzumab,first administration at the dose of 8mg/Kg IV, subsequent administrations at the dose of 6mg/Kg IV,every 3 weeks for 6 cycles
16329353|NCT00429234|Drug|Dasatinib|Starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks.
16329354|NCT00429234|Drug|Gemcitabine|Starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
16329355|NCT00429221|Behavioral|Tailored Medication Messages for Parents|
16329356|NCT00429208|Drug|Nicotine|
16329357|NCT00429195|Behavioral|Dietary Fatty Acid Modification|
16329358|NCT00429182|Drug|Carboplatin|Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
16329359|NCT00429182|Drug|Cyclophosphamide|1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
16329360|NCT00429182|Drug|Thiotepa|120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
16329361|NCT00429182|Procedure|Stem Cell Transplant|Stem Cell Transplant on Day 0.
16329362|NCT00429169|Drug|Paroxetine|Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment.
16329363|NCT00429169|Drug|Bupropion|Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment.
16329364|NCT00429156|Device|Home non-invasive ventilation|Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home NIV for 1 year.
16329365|NCT00429156|Device|Home non-invasive ventilation (sham)|Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home sham NIV (CPAP 5 cm H2O) for 1 year.
16329366|NCT00429143|Radiation|Total Body Irradiation (TBI)|TBI twice daily days 6-9 prior to transplant (HSCT)
16329367|NCT00429143|Biological|Donor Lymphocyte Infusion (DLI)|DLI given 6 days prior to transplant (HSCT).
16329368|NCT00429143|Drug|Cyclophosphamide (CY)|Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
16329369|NCT00429143|Drug|Tacrolimus|Tacrolimus given one day prior to transplant (HSCT).
16329370|NCT00429143|Drug|Mycophenolate Mofetil (MMF)|MMF given one day prior to transplant (HSCT).
16329371|NCT00429143|Biological|Hematopoietic Stem Cell Transplant (HSCT)|CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed. This is the day of transplantation.
16329372|NCT00429117|Behavioral|Survey|Internet survey lasting 30 to 40 minutes.
16329373|NCT00429104|Drug|Herceptin|4 mg/kg IV Over 90 Minutes
16329375|NCT00429091|Drug|ABT-894|Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
16329376|NCT00429091|Drug|atomoxetine|Subjects will take 40 mg BID or placebo for up to four weeks.
16329377|NCT00429091|Drug|placebo|Subjects will take BID for up to four weeks
16329378|NCT00429078|Genetic|2nd Generation Designer T Cells|
16329379|NCT00429065|Drug|Rituximab|
16329380|NCT00429039|Drug|L-leucyl-L-leucine methyl ester (LLME)|
16329381|NCT00429026|Drug|Fludarabine|25 mg/m^2 intravenous (IV) daily for 5 Days
16329382|NCT00429026|Drug|Melphalan|70 mg/m^2 IV Daily for 2 Days
16329383|NCT00429026|Drug|Cyclophosphamide|60 mg/kg IV Daily for 2 Days
16329384|NCT00429026|Procedure|Stem Cell Transplant|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor
16329385|NCT00429013|Device|Tongue Display Unit|lingual electric stimulation
16329386|NCT00429000|Device|thermospot|
16329387|NCT00428974|Drug|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
16329388|NCT00428974|Drug|CF101 2mg|CF101 2 mg q12 hours for 12 weeks
16329389|NCT00428974|Drug|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
16329390|NCT00428974|Drug|Placebo|Placebo tablets q12 hours for 12 weeks
16329391|NCT00428948|Drug|Tolvaptan|Tolvaptan was supplied as tablets.
16329392|NCT00428948|Drug|Placebo|Placebo was supplied as tablets.
16329393|NCT00428935|Biological|rAAV2.5-CMV-minidystrophin (d3990)|Recombinant adeno-associated virus (AAV) carrying a truncated human dystrophin gene (mini-dystrophin) expressed from a cytomegalovirus (CMV) promoter.
16329394|NCT00428922|Drug|Trastuzumab|administered every three weeks on day 1, every 21 days. The dose given will be 6 mg/kg. The initial loading dose is 8mg/kg and is administered as a 90-minute infusion. Thereafter, the maintenance dose is 6mg/kg every three weeks administered as a 30 minute infusion (unless the treating physician indicates a longer infusion duration is warranted). Trastuzumab is given prior to bevacizumab. Trastuzumab is to be continued until disease progression or unacceptable toxicity.
16329395|NCT00428922|Drug|Bevacizumab|administered every three weeks on day 1, every 21 days. The dose given will be 15 mg/kg. The initial dose is administered over 90 minutes. If the first infusion is well tolerated, the second dose is given over 60 minutes, and if that is well tolerated, then subsequent doses may be given over 30 minutes. Avastin is given after trastuzumab and prior to docetaxel.
16329396|NCT00428922|Drug|Docetaxel|administered every three weeks on day 1, every 21 days. The dose given will be 75 mg/M². All doses of docetaxel are administered over 60 minutes. Docetaxel is given after trastuzumab and bevacizumab.
16329397|NCT00428909|Drug|Imatinib/Acetaminophen|
16329398|NCT00428896|Drug|ZD1839|ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
16329399|NCT00428883|Drug|N-acetylcysteine (NAC)|
16329400|NCT00428870|Procedure|Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)|
16329401|NCT00428857|Procedure|non invasive ventilation|non invasive ventilation
16329402|NCT00428844|Drug|daptomycin|6 mg/kg
16329403|NCT00428844|Drug|daptomycin|8 mg/kg
16329404|NCT00428844|Drug|vancomycin|1 gram
16329405|NCT00428844|Drug|teicoplanin|6 mg/kg; used only at UK sites
16329406|NCT00428844|Drug|nafcillin|1-2 gram
16329407|NCT00428844|Drug|oxacillin|1-2 gram
16329408|NCT00428844|Drug|flucloxacillin|1-2 mg
16329409|NCT00428818|Drug|trimethoprim-sulfamethoxazole or doxycycline|
16329410|NCT00428805|Behavioral|classroom curriculum|"classroom curriculum for 3 & 4 year old children includes activities to increase intake of fruits, vegetables, & whole grains; increase physical activity; decrease intake of fats and sugared drinks; and decrease screen time following monthly learning modules.
~Teachers are trained to carry out the classroom curriculum."
16329411|NCT00428805|Behavioral|In-service training for Head Start teachers/aides|Teachers and teacher aides are trained quarterly by certified trainers and receive a certificate for participating in the training. Topics include the content as well as developmental concepts.
16329412|NCT00428805|Behavioral|Training for Head Start food service|Food service workers are trained (quarterly) to modify food ordering, food preparation, and food serving to match the aims of the study
16329413|NCT00428805|Behavioral|Family intervention component|Families receive the CHILE intervention quarterly at Family Events. These include family activities to increase intake of fruits, vegetables, whole grains, decrease intake of fats and sugared drinks, increase of physical activity and decrease screen time. Parenting skills are also included.
16329414|NCT00428805|Behavioral|Food source|The grocery store component includes field trips, self labeling, and taste testing of promoted foods.
16329415|NCT00428805|Behavioral|Health care providers|The health care provider component includes the health care providers presenting at the Family Events and reinforcing the CHILE intervention message in the practice setting when talking with families of head start children.
16329416|NCT00428805|Behavioral|CHILE Head Start Intervention|There are six components of this transcommunity social-ecological intervention including a classroom curriculum, health care provider component, family component, training of Head Start teachers/aides, training of food service staff and grocery store component.
16329417|NCT00428792|Drug|Methylphenidate 20 mg long-acting capsules|
16329418|NCT00428779|Procedure|running during 24 hours without sleep|patients running during 24 hours without sleep
16329419|NCT00428779|Other|no sleeping|patients without sleep during 24 hours
16329420|NCT00428766|Drug|MORAb-003|
16329421|NCT00428727|Drug|Controlled nitric oxide releasing patch|daily application of nitric oxide patch during 90 days
16329422|NCT00428727|Drug|placebo patch|daily application during 90 days
16329423|NCT00428714|Drug|enzastaurin|Administered orally
16329424|NCT00428701|Drug|Esomeprazole Sodium|
16329425|NCT00428662|Device|drug eluting nonpolymeric nanoporous stent|
16329426|NCT00428649|Dietary Supplement|20 µg selenium|20 µg selenium as selenomethionine
16329427|NCT00428649|Dietary Supplement|40 µg selenium|40 µg selenium as selenomethionine
16329428|NCT00428649|Dietary Supplement|60 µg selenium|60 µg selenium as selenomethionine
16329429|NCT00428649|Dietary Supplement|80 µg selenium|80 µg selenium as selenomethionine
16329538|NCT00427856|Drug|Rituximab|Rituximab
16329430|NCT00428649|Dietary Supplement|100 µg selenium|100 µg selenium as selenomethionine
16329431|NCT00428649|Dietary Supplement|120 µg selenium|120 µg selenium as selenomethionine
16329432|NCT00428649|Dietary Supplement|placebo|placebo
16329433|NCT00428636|Procedure|ileostomy|
16329434|NCT00428623|Procedure|wound dressing|
16329435|NCT00428610|Drug|LY573636-sodium|LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
16329436|NCT00428597|Drug|sunitinib malate|"sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
~Dose may be decreased to 25 mg daily in case of adverse events.
~It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
~Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination."
16329437|NCT00428597|Drug|Placebo|Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
16329438|NCT00428584|Drug|New Formulation of rebif - human interferon beta-1a|New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
16329439|NCT00428584|Drug|Interferon beta -1b|Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
16329440|NCT00428571|Procedure|laparoscopic gastric bypass surgery|Laparoscopic Gastric Bypass Surgery
16329441|NCT00428571|Procedure|laparoscopic adjustable gastric banding|laparoscopic adjustable gastric banding
16329442|NCT00428571|Procedure|Intensive Medical Management|lifestyle, diet, medication optimization
16329443|NCT00428558|Drug|Chemotherapy (DAUNORUBICINE-CYTARABINE)|A Phase 3 Trial of Systematic versus Response-adapted Timed-SEQUENTIAL Induction in Patients with Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)
16329444|NCT00428558|Drug|Chemotherapy (DAUNORUBICINE-CYTARABINE)|Chemotherapy induction sequential
16329445|NCT00428545|Drug|Bevacizumab|Starting Dose 2.5 mg/kg By Vein On Day 1 Every 21 Days
16329446|NCT00428545|Drug|Bortezomib|Starting Dose 0.7 mg/m^2 By Vein On Days 1 and 8 Every 21 Days
16329447|NCT00428532|Drug|Licorice root extract or Pomegranate juice|
16329448|NCT00428519|Drug|Placebo|Placebo for 14 days
16329449|NCT00428519|Drug|Aprepitant|Aprepitant at a dose of 125 mg daily for 14 days
16329450|NCT00428519|Drug|Aprepitant|Aprepitant at a dose of 250 mg daily for 14 days
16329451|NCT00428506|Drug|albumin 4 gr/L ascites removed|albumin 4 gr/L ascites removed
16329452|NCT00428506|Drug|albumin 8 gr/L ascites removed|albumin 8 gr/L ascites removed
16329453|NCT00428480|Behavioral|Daily reinforcement of walking speed (DRS)|Inpatients are encouraged to walk faster and given feedback on their walking speed during a daily 10-meter walk as part of their usual physical therapy.
16329454|NCT00428480|Behavioral|No reinforcement of walking speed (NRS)|Inpatients complete a 10-meter walk as part of their daily physical therapy but are not given any encouragement to walk faster or feedback on their walking speed.
16329455|NCT00428467|Procedure|LV Apex Compression|
16329456|NCT00428454|Device|sirolimus-eluting stent, zotarolimus-eluting stent|PCI in chronically occluded coronary artery
16329457|NCT00428441|Drug|Warfarin|tablets, based on INR levels, according to D-dimer levels
16329458|NCT00428428|Drug|Isoproterenol|ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
16329459|NCT00428415|Drug|Tesofensine|
16329460|NCT00428402|Behavioral|Focus Group Discussion|Focus groups meeting for up to 1 hour during the regular school day.
16329461|NCT00428389|Drug|Rivastigmine 5 cm^2 transdermal patch|Rivastigmine 5 cm^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.
16329462|NCT00428389|Drug|Rivastigmine 10 cm^2 transdermal patch|Rivastigmine 10 cm^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.
16329463|NCT00428376|Device|Building Blocks|
16329464|NCT00428363|Device|Cataract surgery with implantation of an intraocular lens|
16329465|NCT00428350|Drug|Quetiapine Fumarate (Seroquel)|
16329466|NCT00428337|Biological|EP-1233|DNA-HIV-recombinant vaccine
16329467|NCT00428337|Biological|MVA-mBN32|HIV-recombinant viral vaccine
16329468|NCT00428311|Drug|Metformin|
16329469|NCT00428311|Drug|Ethynyl-estradiol plus cyproterone acetate|
16329470|NCT00428298|Drug|Valacyclovir|Subjects take two 500 mg capsules twice daily for 16 weeks.
16329471|NCT00428298|Drug|Placebo|Subjects take two 500 mg capsules twice daily for 16 weeks.
16329472|NCT00428285|Procedure|Argon Plasma Coagulation|Argon Plasma Coagulation (APC) is a non-contact electrosurgical technique delivering a high-frequency electrical current through ionized argon gas i.e. the argon plasma. This current produces a zone of coagulation, desiccation, and devitalisation 2-3 mm deep. Patients will be offered up to 3 treatments if recurrence occur after the first two.
16329473|NCT00428272|Drug|Lexatumumab alone|Dose escalation : 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg
16329474|NCT00428272|Drug|Lexatumumab in combination|Dose escalation : 1mg/kg, 3mg/kg, 5mg/kg, 8mg/kg, 10mg/kg
16329475|NCT00428272|Drug|Interferon gamma 1b in combination|Dosing at the following for each lexatumumab dose level: .75mcg/m2/dose and 25mcg/m2/dose
16329476|NCT00428272|Drug|Gamma 1b potential expansion|Potential expansion (at 10mg/kg lexatumumab): 1.5mcg/m2/dose and 50mcg/m2/dose
16329477|NCT00428246|Drug|paricalcitol|1 mcg or 2 mcg for 4 weeks.
16329478|NCT00428246|Drug|Placebo|Placebo
16329479|NCT00428233|Procedure|Leukemia cell harvest|Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node
16329480|NCT00428220|Drug|sunitinib|sunitinib
16329481|NCT00428207|Drug|Insulin Aspart versus Insulin Lispro|Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.
16329482|NCT00428207|Drug|Insulin Lispro versus Insulin Aspart|Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients.
16329483|NCT00428194|Drug|cisplatin|40 mg/m^2 every 7 days during radiation
16329484|NCT00428194|Drug|erlotinib hydrochloride|Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
16329485|NCT00428194|Procedure|radiation therapy|standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
16329486|NCT00428181|Behavioral|Brief alcohol intervention|Brief alcohol intervention
16329487|NCT00428181|Behavioral|Brief alcohol intervention plus booster|Brief alcohol intervention plus booster in a later session
16329488|NCT00428168|Drug|Betahistine|Betahistine 24mg BID
16329489|NCT00428155|Device|closure device placement|
16329490|NCT00428142|Biological|rituximab|375mg/m2 day 1
16329491|NCT00428142|Drug|bortezomib|1.3mg/m2 days 1 & 8
16329492|NCT00428142|Drug|cyclophosphamide|750mg/m2 day 1
16329493|NCT00428142|Drug|prednisone|40mg/m2 days 1-5
16329494|NCT00428142|Drug|vincristine sulfate|1.4mg/m2 day 1 (dose capped at 2mg)
16329495|NCT00428129|Drug|microplasmin|20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
16329496|NCT00428116|Drug|HAART|Combination first line antiretrovirals as previously described.
16329497|NCT00428103|Procedure|3 dimensional echocardiography|Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
16329498|NCT00428090|Drug|Rosiglitazone|XR (extended release) oral tablets
16329499|NCT00428077|Biological|bcr-abl peptide vaccine|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
16329500|NCT00428077|Genetic|reverse transcriptase-polymerase chain reaction|"A baseline reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a baseline circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction."
16329501|NCT00428064|Drug|Sirolimus|
16329502|NCT00428064|Drug|cyclosporine|
16329503|NCT00428051|Other|Surveillance|No study drug, only interventions are blood draws and Chest X-rays
16329504|NCT00428025|Drug|diclofenac|100 mg diclofenac rectal suppository
16329505|NCT00428025|Drug|placebo|similar shape and size suppository
16329506|NCT00428012|Behavioral|Quality of Life Therapy|8 weekly individual counseling sessions
16329507|NCT00428012|Behavioral|Supportive Therapy|8 weekly individual counseling sessions
16329508|NCT00427999|Drug|imatinib mesylate|
16329509|NCT00427999|Drug|Treosulfane|
16329510|NCT00427999|Drug|etoricoxib|
16329511|NCT00427999|Drug|pioglitazone|
16329512|NCT00427999|Drug|dexamethasone|
16329513|NCT00427986|Drug|Galactose, intravenous|
16329514|NCT00427973|Drug|cediranib maleate|Given orally
16329515|NCT00427973|Other|laboratory biomarker analysis|Peripheral blood was obtained from all patients enrolled for studies of early changes in circulating proangiogenic and proinflammatory molecules and cells. Blood samples were collected in EDTA-containing tubes before and after cediranib therapy on days 1 and 14 of cycle 1. Circulating VEGF, placental growth factor (PlGF), sVEGFR1, basic fibroblast growth factor (bFGF), interleukin (IL)-6, IL-8, transforming growth factor a ((TNF-a), gamma interferon (IFN-g) were measured using multiplex ELISA plates from Meso-Scale Discovery. Hepatocyte growth factor (HGF), insulin-like growth factor 1 (IGF-1), sVEGFR2, angiopoietin 2 (Ang-2), sTie2, soluble c-KIT, carbon anhydrase 9 (CAIX), and stromal cell-derived factor-1a (SDF1a) were measured using ELISA kits from R&D Systems.
16329516|NCT00427973|Procedure|computed tomography|computed tomography (CT) every 8 weeks to evaluate response and progression.
16329517|NCT00427973|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Magnetic resonance imaging (MRI) every 8 weeks to evaluate response and progression.
16329518|NCT00427973|Other|pharmacological study|Blood samples to characterize the steady-state PK of cediranib were drawn from a peripheral vein shortly before patients received the dose on days 8 and 15 of cycle 1 and at the following times relative to dosing on day 1 of cycle 2: 5 min and 1, 2, 4, 6, 8, and 24 hours, with the last sample collected before taking the next daily dose.
16329519|NCT00427960|Behavioral|Dietary advice|
16329520|NCT00427960|Drug|rosuvastatin|rosuvastatin 5 mg
16329521|NCT00427960|Drug|atorvastatin|atorvastatin 10 mg
16329522|NCT00427947|Drug|ropivacaine/placebo|Continuous sciatic nerve bloc
16329523|NCT00427934|Drug|Maraviroc|300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
16329524|NCT00427934|Drug|Maraviroc Placebo|Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
16329525|NCT00427921|Biological|adalimumab|160 mg loading dose, 80 mg at week 2, 40 mg every other week
16329526|NCT00427908|Biological|GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)|One intramuscular dose.
16329527|NCT00427908|Biological|Mencevax™ ACWY|One subcutaneous dose.
16329528|NCT00427908|Biological|Meningitec™|One intramuscular dose.
16329529|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
16329530|NCT00427895|Biological|23-valent Pneumococcal Polysaccharide Vaccine (23vPS)|0.5 mL dose administered on day 1
16329531|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
16329532|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered on day 1
16329533|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered 3-4 years after dose 1
16329534|NCT00427895|Biological|23-valent Pneumococcal Polysaccharide Vaccine (23vPS)|0.5 mL dose administered 3-4 years after dose 1
16329535|NCT00427895|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL dose administered 3-4 years after dose 1
16329536|NCT00427882|Drug|ALFUZOSIN|
16329537|NCT00427856|Drug|Obatoclax mesylate|Obatoclax mesylate 40mg, and 60mg
16329539|NCT00427843|Behavioral|home exercise program for the hip abductor muscles|"All patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs.
~The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns."
16329540|NCT00427830|Biological|MVA85A|
16329541|NCT00427804|Drug|calcitriol|0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose
16329542|NCT00427791|Drug|Etoposide|60 mg/kg IV Daily Over 4 Hours for 1 Day
16329543|NCT00427791|Radiation|Total Body Irradiation|3 Gy Daily for 4 Days
16329544|NCT00427791|Drug|Rituximab|375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
16329545|NCT00427778|Device|incontinence ring|"Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.
~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
16329546|NCT00427765|Drug|Busulfan|Test Dose = 32 mg/m^2 IV for 1 Day; 130 mg/m^2 IV for 4 Days
16329547|NCT00427765|Drug|Melphalan|70 mg/m^2 IV for 2 Days
16329548|NCT00427752|Procedure|Transgastric endoscopic peritoneoscopy.|Exploration of the abdominal area
16329549|NCT00427739|Procedure|Cardiac CT|64 slice spiral computerized tomography
16329550|NCT00427713|Drug|capecitabine|
16329551|NCT00427713|Drug|oxaliplatin|
16329552|NCT00427713|Procedure|adjuvant therapy|
16329553|NCT00427713|Procedure|standard follow-up care|
16329554|NCT00427700|Drug|clomiphene citrate|100mg PO on days 5-9 of the menstrual cycle
16329555|NCT00427700|Drug|raloxifene|100mg PO on days 5-9 of the menstrual cycle
16329556|NCT00427687|Drug|AGG-523|
16329557|NCT00427674|Drug|[123I] mZINT injection and serial dynamic SPECT imaging|Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.
16329558|NCT00427661|Other|Busulfan; Fludarabine; cyclosporine A and MMF|Hematopoietic stem cell transplantation from a matched sibling or unrelated donor following a reduced intensity conditioning regimen
16329559|NCT00427648|Drug|alkalinized xylocaine|30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
16329560|NCT00427648|Drug|placebo|normal saline
16329561|NCT00427635|Drug|Esomeprazole|
16329562|NCT00427622|Other|physiologic testing|
16329563|NCT00427609|Drug|Bicillin L-A|Bicillin L-A administered intramusculary in a dose of 2.4 million units every three weeks or normal saline injection administered intramusculary in a dose of 3 cc every three weeks
16329564|NCT00427596|Drug|Solabegron|
16329565|NCT00427583|Drug|imatinib mesylate|
16329566|NCT00427570|Biological|BCG vaccine|
16329567|NCT00427570|Biological|biological therapy|
16329568|NCT00427570|Drug|fluorouracil|
16329569|NCT00427570|Drug|semustine|
16329570|NCT00427570|Drug|vincristine sulfate|
16329571|NCT00427557|Drug|Fludarabine|30 mg/m^2 by vein for 4 Days (Day -10 through Day -7).
16329572|NCT00427557|Drug|Melphalan|140 mg/m^2 by vein for 1 Day (Day -7).
16329573|NCT00427557|Procedure|Umbilical Cord Blood|1 UCB Unit by vein on Day -5.
16329574|NCT00427557|Drug|Rituximab|375 mg/m^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).
16329575|NCT00427557|Other|Peripheral Blood Stem Cell Infusion|Infusion of blood stem cells on Day 0.
16329576|NCT00427544|Drug|PRA-027|
16329577|NCT00427531|Other|physiologic testing|
16329578|NCT00427505|Drug|Deferasirox|
16329579|NCT00427492|Drug|Magnesia|Tablet magnesia 500mg. 2 tablet 2 times a day for a week
16329580|NCT00427492|Drug|Placebo|
16329581|NCT00427466|Drug|Pemetrexed|
16329582|NCT00427453|Biological|MVA85A|
16329583|NCT00427440|Drug|AMG 102 at 20 mg/kg|AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
16329584|NCT00427440|Drug|AMG 102 at 10 mg/kg|AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
16329585|NCT00427427|Drug|Trastuzumab|
16329586|NCT00427414|Drug|liposomal daunorubicin citrate|40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
16329587|NCT00427401|Drug|PF-00915275|
16329588|NCT00427388|Drug|Methylprednisolone|Given by IV in 2 doses (250 mg each dose for a total of 500 mg)
16329589|NCT00427388|Other|Placebo|Given in 2 IV doses (approximately 4 ml of 0.9% normal saline solution in each dose)
16329590|NCT00427375|Procedure|local rectal excision|New surgical option in good responders after neoadjuvant treatment for low rectal cancer
16329591|NCT00427375|Procedure|total mesorectal excision|standard surgery
16329592|NCT00427362|Drug|Adalimumab|
16329593|NCT00427349|Drug|AMG 706|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment
16329594|NCT00427349|Drug|octreotide|One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.
16329595|NCT00427336|Drug|Fludarabine|30 mg/m^2 by vein daily over 30 minutes
16329596|NCT00427336|Drug|Cyclophosphamide|300 mg/m^2 by vein daily over 2 hours
16329597|NCT00427336|Drug|Antithymocyte Globulin|3.75 mg/kg by vein daily over 4 hours
16329598|NCT00427323|Procedure|light exposure|
16329599|NCT00427310|Drug|fluorouracil|
16329600|NCT00427310|Other|Observation|
16329601|NCT00427310|Drug|sodium heparin|
16329602|NCT00427297|Drug|AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)|First line regimen
16329603|NCT00427297|Drug|d4T/3TC/NVP (stavudine/lamivudine/nevirapine)|First line regimen
16329604|NCT00427297|Drug|AZT/3TC/ABC (zidovudine/lamivudine/abacavir)|First line regimen
16329605|NCT00427297|Drug|d4T/3TC/ABC (stavudine/lamivudine/abacavir)|First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.
16329606|NCT00427297|Drug|ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir)|Second line regimen
16329607|NCT00427297|Drug|ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz)|Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
16329608|NCT00427297|Drug|ABC/3TC/NVP (abacavir/lamivudine/nevirapine)|First line regimen
16329609|NCT00427271|Drug|aspirin|
16329610|NCT00427258|Drug|MOA-728|
16329611|NCT00427245|Drug|cyclophosphamide|
16329612|NCT00427245|Drug|goserelin acetate|
16329613|NCT00427245|Procedure|adjuvant therapy|
16329614|NCT00427245|Procedure|fertility assessment and management|
16329615|NCT00427245|Procedure|neoadjuvant therapy|
16329616|NCT00427232|Drug|BQ-123 and BQ-788|
16329617|NCT00427219|Drug|Ozarelix|Ozarelix 15 mg will be administered IM on Day 0 and Day 14.
16329618|NCT00427219|Drug|Placebo|Placebo will be administered IM on Day 0 and Day 14.
16329619|NCT00427206|Drug|acetaminophen (4g/day)|
16329620|NCT00427206|Drug|placebo|
16329621|NCT00427193|Behavioral|Caloric Restriction (CR)|Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
16329622|NCT00427193|Behavioral|Control|Participants continue their current diet for 24 months
16329623|NCT00427180|Device|Retinal Implant System (IRIS)|AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
16329624|NCT00427167|Biological|AMA1-C1/Alhydrogel + CPG 7909 (Saline)|
16329625|NCT00427167|Biological|AMA1-C1/Alhydrogel + CPG 7909 (Phosphate)|
16329626|NCT00427167|Drug|AMA1-C1/Alhydrogel + CPG 7909|
16329627|NCT00427154|Drug|rosiglitazone|Tablets, 4 mg once or twice daily.
16329628|NCT00427154|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16329629|NCT00427154|Drug|metformin|Tablets, 2000 mg/day.
16329630|NCT00427154|Drug|glimepiride|Tablets, 8 mg/day.
16329631|NCT00427141|Drug|GSK580416|
16329632|NCT00427128|Drug|fluoxetine|10mg/day increased over 12 weeks to 20-80 mg/day; 20-80 mg/day maintained from week 13-36.
16329633|NCT00427128|Drug|placebo|Week 13-36.
16329634|NCT00427115|Behavioral|Multimodal exercise and psychosocial program|
16329635|NCT00427102|Drug|Oral MRX-1024|
16329636|NCT00427102|Procedure|Standard Fractionation Radiation Therapy|
16329637|NCT00427102|Drug|High-Dose Cisplatin Chemotherapy|
16329638|NCT00427089|Drug|Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate|2L gut lavage solution
16329639|NCT00427089|Drug|Sodium Phosphate solution (NaP)|45 ml solution; BID
16329640|NCT00427076|Drug|Cotrimoxazole|Cotrimoxazole arm: intravenous cotrimoxazole 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 12 hours. Patients intolerant of volume overload will be given the same dose in 250ml D5W (as in the current recommendations used in the hospital). The dose was selected basing on the existing randomized controlled trial and a pharmacokinetic study . 21 For patients with GFR< 30 the dosage interval will be increased to 4 amp (320 mg trimethoprim/ 1600 mg sulfamethoxazole) diluted in 500 ml D5W or N.S. Q 24 hours. 22 Patients on peritoneal dialysis will be given 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) Q 48 hours. Patients with acute renal failure treated with hemodialysis will be given the 2 amp (160 mg trimethoprim/ 800 mg sulfamethoxazole) after dialysis. Patients on continuous hemofiltration for acute renal failure will be administered the dose for GFR<30.
16329641|NCT00427076|Drug|Vancomycin|intravenous vancomycin 1gr Q 12 hours. Adjustment to creatinine clearance: GFR 10-50 1 gr Q 24-96 hours, GFR <10 1gr Q 4-7 days.
16329642|NCT00427050|Drug|PEP005|
16329643|NCT00427037|Drug|Cholecalciferol|50,000 IU weekly by mouth
16329644|NCT00427037|Drug|Placebo|identical placebo pill orally by mouth
16329645|NCT00427011|Drug|E2007|E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.
16329646|NCT00426998|Drug|Verteporfin|
16329647|NCT00426998|Drug|Bevacizumab|
16329648|NCT00426985|Drug|Ketoprofen Topical Patch 20%|
16329649|NCT00426972|Drug|estradiol (Zesteem)|
16329650|NCT00426959|Device|Image Guided Dynamic Dosimetry|Image Guided Dynamic Dosimetry
16329651|NCT00426946|Drug|Reboxetine|
16329652|NCT00426933|Drug|Daptomycin|
16329653|NCT00426933|Drug|Vancomycin|
16329654|NCT00426920|Drug|Insulin|
16329655|NCT00426907|Procedure|Unlimited postoperative weightbearing|Unlimited postoperative weightbearing
16329656|NCT00426894|Procedure|samples from nostrils, mouth, axillas, perianal area and postoperative wound|
16329657|NCT00426881|Behavioral|Exercise Training|Twice weekly resistance training for 52 weeks.
16329658|NCT00426881|Behavioral|Exercise training|Once weekly resistance training for 52 weeks.
16329659|NCT00426881|Behavioral|Exercise training|Twice weekly resistance training for 52 weeks.
16329660|NCT00426868|Other|Direct injection of ADRCs into the Left Ventricle|Dose escalation
16329661|NCT00426868|Other|Direct injection of placebo into the Left Ventricle|
16329662|NCT00426855|Drug|Bendamustine|starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
16329663|NCT00426855|Drug|Bortezomib|weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
16329664|NCT00426842|Drug|Midodrine Hydrochloride|Alpha1-agonist, exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure.
16329665|NCT00426829|Drug|Bevacizumab|10 mg/kg by vein every 14 days +/- 2 days, starting on day 1.
16329766|NCT00425906|Drug|nicotine|
16329666|NCT00426829|Radiation|Proton Radiation Therapy|3 Gy dose/fraction x 20 fractions.
16329667|NCT00426816|Drug|SB-649868|Active compound at doses of 10mg, 30mg and 60mg
16329668|NCT00426816|Drug|Placebo|Placebo to match SB-649868
16329669|NCT00426803|Drug|activated recombinant human factor VII|
16329670|NCT00426790|Procedure|Positive end-expiratory pressure|
16329671|NCT00426777|Drug|risedronate|risedronate 35mg tablet, weekly for 12 months
16329672|NCT00426777|Drug|risedronate|35mg weekly
16329673|NCT00426777|Drug|Control|risedronate-matched placebo weekly
16329674|NCT00426764|Drug|Romidepsin|Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.
16329675|NCT00426751|Drug|Abciximab|Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
16329676|NCT00426751|Drug|Eptifibatide|Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.
16329677|NCT00426725|Device|EasyLabour|According to the trial protocol
16329678|NCT00426712|Biological|1018 ISS immunostimulatory oligonucleotide with HBV surface antigen|Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
16329679|NCT00426712|Biological|Hepatitis B Vaccine (Recombinant)|IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
16329680|NCT00426673|Drug|Brivaracetam (ucb34714)|
16329681|NCT00426660|Drug|maraviroc|The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
16329682|NCT00426647|Drug|Buprenorphine|
16329683|NCT00426647|Drug|Tramadol|
16329684|NCT00426621|Drug|Diclofenac Sodium Gel|4 grams per knee, 4 times per day, for 12 weeks
16329685|NCT00426621|Drug|Placebo|4 grams per knee, 4 times per day, for 12 weeks
16329686|NCT00426608|Drug|metyrapone|Metyrapone will be available as 250 mg dose capsule.
16329687|NCT00426608|Drug|alprazolam|Alprazolam capsules will be available with dose strength of 0.25mg
16329688|NCT00426608|Drug|placebo|GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.
16329689|NCT00426608|Drug|GSK561679|GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
16329690|NCT00426595|Drug|Administration of omeprazole suspension|
16329691|NCT00426595|Drug|omeprazole administered as a multi-unit-pellet system|
16329692|NCT00426582|Drug|Patupilone|
16329693|NCT00426556|Drug|Everolimus|Everolimus (RAD001) was supplied as tablets in 3 different dosage strengths, 2.5, 5, and 10 mg. The drug was packaged in blisters containing 10 tablets per blister. Blisters and packaging labels were compliant with local regulations and were printed in local language.
16329694|NCT00426556|Drug|Trastuzumab|Commercially-available trastuzumab was used in this study. A 4 mg/kg loading dose was administered, intra-venous (IV), over 90 minutes on Day 1 (if patient was not already receiving trastuzumab); this was followed by weekly trastuzumab 2 mg/kg IV administered over 30 minutes. For patients who continued to receive trastuzumab and everolimus after completion/discontinuation of chemotherapy in the core treatment phase, trastuzumab may have been administered once every 3 weeks at a dose of 6 mg/kg. PT = Paclitaxel & Trastuzumab
16329695|NCT00426556|Drug|Paclitaxel|Commercially-available paclitaxel was used in this study. Paclitaxel infusion was administered on Days 1, 8, and 15 of each 28-day cycle, after administration of trastuzumab. Paclitaxel (80 mg/m2) was administered as a 60-minute continuous IV infusion after standard premedication. Patients received paclitaxel for 6 cycles. At the investigator's discretion, treatment with paclitaxel could continue beyond 6 cycles.
16329696|NCT00426543|Drug|MabThera (rituximab)|1000 mg infusion twice with 14 days interval
16329697|NCT00426543|Drug|Rituximab, Mabthera|1000 mg Rituximab infusion in 500 ml isotonic sodiumchloride twice with 14 days interval
16329698|NCT00426530|Drug|everolimus (RAD001)|
16329699|NCT00426517|Drug|Campath 1H|Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days
16329700|NCT00426517|Drug|Busulfan|Busulfan 5-10 mg/kg total dose given intravenously over 2 days based on patient underlining immune deficiency disorder
16329701|NCT00426517|Drug|Horse Anti-human Thymocyte Globulin (h-ATG)|Conditioning with h-ATG 40 mg/kg total dose over 4 days given intravenously
16329702|NCT00426517|Drug|Total Body Irradiation (TBI)|TBI 200 - 300 centigray (cGy) in two fractions at day -2 or same day depending on patient underlining immune deficiency disorder
16329703|NCT00426517|Drug|Sirolimus or equivalent based on response|post Transplantation immunosuppressants
16329704|NCT00426504|Procedure|Radiotherapy|Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) with the intend of delivering radical radiotherapy to a dose of 66-70 Gy to involved areas and at least 50 Gy to un-involved sites to be treated prophylactically.
16329705|NCT00426491|Drug|Misoprostol|400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.
16329706|NCT00426478|Drug|Valsartan plus Hydrochlorothiazide (80mg/12.5mg)|
16329707|NCT00426478|Drug|Amlodipine (5mg)|
16329708|NCT00426452|Drug|Vatalinib|
16329709|NCT00426439|Drug|Chloroquine|Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.
16329710|NCT00426439|Drug|Artemether-lumefantrine (Coartem)|Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
16329711|NCT00426426|Behavioral|Cognitive-Behavioural Therapy|12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.
16329712|NCT00426426|Behavioral|Meta-Cognitive Therapy|12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .
16329713|NCT00426426|Behavioral|Waiting list|
16329714|NCT00426413|Drug|pioglitazone|Obese AA subjects with DKA or severe hyperglycemia that are able to discontinue insulin at 12 weeks or less will be randomized (blinded fashion) to receive either placebo or pioglitazone qd. The subjects will be followed while in the study arm and beta-cell function will be assessed using OGTT at set intervals.
16329715|NCT00426400|Drug|The cessation of anti-aggregative treatment for 10 days|
16329716|NCT00426374|Procedure|echocardiography and blood test|
16329717|NCT00426361|Biological|Boostrix ® Polio|One dose of vaccine administered intramuscularly
16329718|NCT00426361|Biological|GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively
16329719|NCT00426348|Drug|Valsartan|Valsartan (80-160mg/day)
16329720|NCT00426348|Drug|Probucol|Probucol (750mg/day)
16329721|NCT00426348|Drug|Placebo|Placebo
16329722|NCT00426322|Device|bovine bone mineral particles (Bio-Oss®)|bovine bone mineral particles used for sinus augmentation prior to dental implant placement
16329723|NCT00426296|Drug|atazanavir (Reyataz)|
16329724|NCT00426296|Drug|ritonavir (Norvir)|
16329725|NCT00426283|Drug|Flovent|1760 mcg daily
16329726|NCT00426283|Other|Placebo|Placebo
16329727|NCT00426270|Drug|Octagam 10%|Octagam 10% was supplied as a ready-to-use solution in glass bottles.
16329728|NCT00426257|Procedure|Secondary debulking|Secondary debulking
16329729|NCT00426257|Procedure|secondary debulking with intraperitoneal chemotherapy|secondary debulking with intraperitoneal chemotherapy
16329730|NCT00426244|Other|Osteopathic Manipulative Treatment|OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.
16329731|NCT00426244|Other|Placebo Ultrasound|"In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT.
~The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects."
16329732|NCT00426231|Behavioral|Navigation by a health worker|Help provided by health worker to navigate medication access programs
16329733|NCT00426231|Behavioral|Information control|Information about medication access programs provided to the participant and their healthcare provider
16329734|NCT00426218|Drug|ACZ885|
16329735|NCT00426205|Biological|GM-CSF secreting leukemia vaccine|Vaccine given subcutaneously or intradermally on the leg, arm, or abdomen 6 times. The first three vaccines will be given once a week for three weeks. The last three vaccines will be given once every other week for three doses.
16329736|NCT00426192|Drug|i.v. mannitol|
16329737|NCT00426192|Procedure|hemofiltration|
16329738|NCT00426179|Drug|Imatinib|
16329739|NCT00426166|Device|Low Level Laser Therapy|Low Level Laser Therapy on Wound
16329740|NCT00426153|Drug|Octreotide|Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year
16329741|NCT00426153|Drug|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
16329742|NCT00426140|Drug|Patupilone|
16329743|NCT00426127|Drug|Docetaxel|
16329744|NCT00426127|Drug|Liposomal Doxorubicin|
16329745|NCT00426127|Drug|Enoxaparin|
16329746|NCT00426114|Drug|Administration of an IV glucose-injection|
16329747|NCT00426101|Drug|Dexamethasone|"10 mg/m2 daily wk 1-2 5 mg/m2 daily wk 3-4 2.5 mg/m2 daily wk 5-6 1.25 mg/m2 daily wk 7 Steroids tapered wk 8
~If continuation:
~Pulses every 2nd wk, 10 mg/m2 for 3 days"
16329748|NCT00426101|Drug|Etoposide|"150 mg/m2 iv twice/wk (wk 1-2) 150 mg/m2 iv once/wk (wk 3-8)
~If continuation:
~150 mg/m2 iv, every 2nd wk"
16329749|NCT00426101|Drug|Cyclosporin|"WK 1-8:
~- Aim at around 200 microgram/L (trough value). Start: 6 mg/kg daily (divided in 2 daily doses) wk 1, if kidney function is normal.
~If continuation:
~- Aim for around 200 microgram/L. Monitor GFR."
16329750|NCT00426101|Procedure|Intrathecal therapy|"If at 2 wks there are progressive neurological symptoms or if an abnormal CSF (cell count and protein) has not improved, then give 4 wkly intrathecal inj. Be aware that some pat may have increased intracranial pressure.
~Methotrexate: <1 yr 6 mg, 1-2 yrs 8 mg, 2-3 yrs 10 mg, >3 yrs 12 mg. Prednisolone: <1 yr 4 mg, 1-2 yrs 6 mg, 2-3 yrs 8 mg, >3 yrs 10 mg."
16329751|NCT00426101|Procedure|Stem cell transplant|The SCT procedure is up to the treating physician. However, a suggested regimen is provided.
16329752|NCT00426075|Device|Elastic stockings|
16329753|NCT00426049|Drug|Everolimus|
16329754|NCT00426036|Drug|Licarbazepine|
16329755|NCT00426023|Drug|Cyclosporine A 0,05% eye drop|Cyclosporine A 0.05% eye drops will be administered 2 times daily for six months in the first year of the study and in the second year of the study in a cross-over manner(from March to September)
16329756|NCT00426023|Drug|ketotifen fumarate 0.025% eye drops|ketotifen fumarate 0.025% eye drops 2 times daily for 6 months in the first year of the study (from March to September) and 6 months in the same period in the second year of the study in cross over manner.
16329757|NCT00426010|Drug|caffeine/placebo|caffeine or placebo, either overt or covert
16329758|NCT00425997|Drug|Valsartan/HCTZ|
16329759|NCT00425997|Drug|amlodipine|
16329760|NCT00425997|Drug|HCTZ|
16329761|NCT00425984|Procedure|Adult male circumcision|
16329762|NCT00425971|Drug|BMEC-1217B|
16329763|NCT00425945|Drug|Pine Bark Extract (Flavangenol®)|"Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
~Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks."
16329764|NCT00425932|Biological|Rituximab|At Week 24 or any time up to Week 48 if the Patient DAS 28 > 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.
16329765|NCT00425919|Drug|PPM-204|
16329768|NCT00425906|Procedure|Quality of life|
16329769|NCT00425893|Behavioral|hand hygiene|alcohol-based hand wash
16329770|NCT00425893|Other|health education|Proper nutrition, etc.
16329771|NCT00425893|Device|face masks|face masks
16329772|NCT00425867|Behavioral|PAR1 polymoprhisms and placental invasion|
16329773|NCT00425854|Drug|BIBW 2992|high dose once daily
16329774|NCT00425841|Drug|gemcitabine hydrochloride|
16329775|NCT00425841|Drug|oxaliplatin|
16329776|NCT00425841|Procedure|adjuvant therapy|
16329777|NCT00425841|Procedure|neoadjuvant therapy|
16329778|NCT00425841|Radiation|hypofractionated radiation therapy|
16329779|NCT00425841|Radiation|stereotactic radiosurgery|
16329780|NCT00425815|Drug|Org 24448|Org 24448 is a moderate-potency selective AMPA positive modulator that enhances the glutamate system in the brain.
16329781|NCT00425815|Other|Placebo|Placebo comparison
16329782|NCT00425802|Biological|anti-thymocyte globulin|
16329783|NCT00425802|Biological|filgrastim|
16329784|NCT00425802|Biological|graft-versus-tumor induction therapy|
16329785|NCT00425802|Biological|rituximab|
16329786|NCT00425802|Drug|cyclophosphamide|
16329787|NCT00425802|Drug|cyclosporine|
16329788|NCT00425802|Drug|fludarabine phosphate|
16329789|NCT00425802|Drug|mycophenolate mofetil|
16329790|NCT00425802|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16329791|NCT00425802|Radiation|total-body irradiation|
16329792|NCT00425789|Procedure|Treatment with Hyperbaric oxygen|
16329793|NCT00425776|Device|acupuncture|
16329794|NCT00425776|Device|Sham acupuncture|
16329795|NCT00425763|Drug|AQAS|AQAS dosed by body weight, on days 0, 1, 2
16329796|NCT00425750|Drug|bortezomib|1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
16329797|NCT00425750|Drug|docetaxel|40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1.
16329798|NCT00425750|Other|laboratory biomarker analysis|Tissue and blood collection.
16329799|NCT00425750|Other|pharmacological study|Blood collection.
16329800|NCT00425737|Biological|Rotarix|
16329801|NCT00425724|Drug|Methylprednisolone pulses plus prednisone versus Cyclosporine A|The patients will be randomised to receive either MP pulses i.v. or cyclosporine A p.o. The MP pulses will consist of three doses of methylprednisolone 30 mg/kg i.v. given over a period of one week in hospital. On the intermediate days and for a month after the MP pulses, the patients will be given prednisone 30 mg/m2/day p.o., after which the prednisone medication will be gradually run down over 3 months. The patients randomised into the cyclosporine A group will receive an initial dose of 5 mg/kg/day, after which the dosage will be titrated to an optimal therapeutic level by monitoring the B-Cya concentration. The cyclosporine A treatment will be continued for 12 months.
16329802|NCT00425711|Drug|Acamprosate|Acamprosate 666 mg tid, or 333 tid in renal impairment, for 12 weeks
16329803|NCT00425698|Drug|Recombinant erythropoietin alpha (rHuEPO alpha)|Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation
16329804|NCT00425698|Drug|Placebo|Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation
16329805|NCT00425672|Biological|ONTAK|Given IV
16329806|NCT00425672|Other|flow cytometry|Correlative studies
16329807|NCT00425672|Other|immunohistochemistry staining method|Correlative studies
16329808|NCT00425672|Other|enzyme-linked immunosorbent assay|Correlative studies
16329809|NCT00425672|Other|laboratory biomarker analysis|Correlative studies
16329810|NCT00425672|Genetic|protein expression analysis|Correlative studies
16329811|NCT00425659|Device|home sleep study|different in algorithm arrangement for diagnosing sleep apnea
16329812|NCT00425659|Device|home CPAP titration (Autoset)|continuous positive airway pressure device for treatment of sleep apnea
16329813|NCT00425659|Device|CPAP|usual practice
16329814|NCT00425646|Biological|bevacizumab|
16329815|NCT00425646|Drug|imatinib mesylate|
16329816|NCT00425633|Drug|Homeopathic Potassium Dichromate|5 pellets under tongue q12h until extubation
16329817|NCT00425620|Drug|SinuNase|Lavage
16329818|NCT00425607|Drug|Lonafarnib|Lonafarnib will be taken orally, twice per day, by all patients enrolled on this study. The drug is supplied to patients in capsule form, and for patients who are unable to swallow pills, the drug may be dissolved into solution. Every patient will start lonafarnib therapy at a dose of 115mg/kg. The study allows for patients to receive a dose escalation (up to 150mg/kg) if the drug is being well-tolerated. Every patient enrolled on this study will undergo two years of lonafarnib therapy.
16329819|NCT00425594|Drug|HalfLytely and Bisacodyl Tablets - Formulation 1|
16329820|NCT00425594|Drug|HalfLytely and Bisacodyl Tablets - Formulation 2|
16329821|NCT00425594|Drug|NuLYTELY|
16329822|NCT00425568|Drug|AndroGel (Transdermal Testosterone Gel)|
16329823|NCT00425555|Drug|Panobinostat|
16329824|NCT00425542|Other|Outpatient care (vs traditional inpatient care)|Patients randomized to the outpatient arm are discharged from the emergency department within 24 hours after randomization. Patients randomized to the inpatient arm are admitted to the hospital and are discharged based on the decision of the managing physician at the hospital.
16329825|NCT00425529|Device|Module AOX (attached to Sondalis ISO)|
16329826|NCT00425516|Drug|Taxotere|
16329827|NCT00425516|Drug|5-Fluorouracil|
16329828|NCT00425516|Drug|Epirubicin|
16329829|NCT00425516|Drug|Cyclophosphamide|
16329830|NCT00425503|Drug|PS-341 (bortezomib)|PS-341 is a dipeptidyl boronic acid inhibitor with high specificity for the proteasome developed by Millennium Pharmaceuticals Inc. to treat human malignancies. It is the first member of this class of anti-tumor agents to come to human trials. Patients will receive PS-341 (1.6mg/m2/dose) by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed.
16329831|NCT00425490|Drug|sitagliptin|
16329832|NCT00425477|Biological|sargramostim|
16329833|NCT00425477|Drug|bexarotene|
16329834|NCT00425477|Genetic|cytogenetic analysis|
16329835|NCT00425477|Genetic|fluorescence in situ hybridization|
16329836|NCT00425477|Other|flow cytometry|
16329837|NCT00425477|Other|laboratory biomarker analysis|
16329838|NCT00425477|Procedure|biopsy|
16329839|NCT00425464|Device|Standard Monofocal Intraocular Lens|"The control (active comparator) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a standard monofocal intraocular lens.
~Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis."
16329840|NCT00425464|Device|Synchrony® Dual Optic Intraocular Lens|"The Synchrony® Dual Optic Intraocular Lens (experimantal) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a Synchrony® Dual Optic Intraocular Lens.
~Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis."
16329841|NCT00425451|Drug|PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip|
16329842|NCT00425438|Drug|Mycophenolate Mofetil|0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48
16329843|NCT00425438|Drug|Corticosteroids|0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
16329844|NCT00425438|Drug|Azathioprine|100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48
16329845|NCT00425438|Drug|Cyclophosphamide|0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24
16329846|NCT00425425|Biological|cetuximab|
16329847|NCT00425425|Drug|fluorouracil|
16329848|NCT00425425|Drug|oxaliplatin|
16329849|NCT00425425|Procedure|conventional surgery|
16329850|NCT00425425|Procedure|neoadjuvant therapy|
16329851|NCT00425425|Radiation|radiation therapy|
16329852|NCT00425399|Procedure|Shiatsu|Shiatsu treatment provided in 40-minute sessions, twice a week for 4 weeks
16329853|NCT00425386|Drug|erlotinib hydrochloride|"Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
~150 mg/day, continuous daily"
16329854|NCT00425386|Drug|sunitinib malate|Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
16329855|NCT00425386|Procedure|biopsy|Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius.
16329856|NCT00425373|Drug|Valsartan + amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329857|NCT00425373|Drug|Valsartan + amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329858|NCT00425373|Drug|Valsartan + amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329859|NCT00425373|Drug|Valsartan + amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329860|NCT00425373|Drug|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329861|NCT00425373|Drug|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
16329862|NCT00425373|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
16329863|NCT00425373|Drug|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
16329864|NCT00425373|Drug|Placebo|4 tablet and 2 capsule placebos taken once daily
16329865|NCT00425360|Biological|sargramostim|
16329866|NCT00425360|Biological|telomerase peptide vaccine GV1001|
16329867|NCT00425360|Drug|capecitabine|
16329868|NCT00425360|Drug|gemcitabine hydrochloride|
16329869|NCT00425347|Drug|HuLuc63|Not applicable for HuLuc63.
16329870|NCT00425334|Drug|Hemospan (MP4OX)|250 mL or 500 mL Hemospan (MP4OX)
16329871|NCT00425334|Drug|Ringer's lactate|250 mL or 500 mL Ringer's lactate USP
16329872|NCT00425321|Drug|RWJ-445380 100 mg|RWJ-445380 100 mg once daily for up to 12 weeks
16329873|NCT00425321|Drug|RWJ-445380 200 mg|RWJ-445380 200 mg once daily for up to 12 weeks
16329874|NCT00425321|Drug|RWJ-445380 300 mg|RWJ-445380 300 mg once daily for up to 12 weeks
16329875|NCT00425321|Drug|Placebo|Placebo once daily for up to 12 weeks
16329876|NCT00425308|Drug|Everolimus + Cyclosporine|
16329877|NCT00425308|Drug|Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)|
16329878|NCT00425308|Drug|Steroids|
16329879|NCT00425295|Behavioral|Human Simulation Training|Fellows will undergo Human Simulation Training (HST) composed of one 1 hour session of high-fidelity simulation of crisis scenarios requiring management of critical care skills, including triage, Advanced Cardiac Life Support (ACLS), team management, and difficult airway management.
16329880|NCT00425282|Drug|RWJ-333369|
16329881|NCT00425269|Behavioral|lifestyle intervention (diet and physical activity)|The intervention will include a combination of individual counselling group sessions. The intervention groups will be divided into subgroups of 10-12 subjects. Each group will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a culturally adapted exercise program of low intensity twice a week.
16329882|NCT00425256|Drug|Bremelanotide|
16329883|NCT00425243|Drug|zolpidem-MR (SL800750)|
16329884|NCT00425230|Drug|Duloxetine|
16329885|NCT00425217|Drug|Rituximab|
16329886|NCT00425204|Drug|Panitumumab (ABX-EGF)|Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.
16330007|NCT00424333|Drug|Inhaled human insulin|
16330008|NCT00424320|Drug|Sodium bicarbonate|
16332080|NCT00408759|Behavioral|hypnosis|
16329887|NCT00425191|Drug|Docetaxel and Gemcitabine|Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8
16329888|NCT00425191|Drug|Docetaxel and Gemcitabine|Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.
16329889|NCT00425191|Drug|Gemcitabine cisplatin followed by docetaxel|Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2
16329890|NCT00425178|Drug|FGF-1|
16329891|NCT00425165|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|Denufosol 60 mg is administered as an inhalation solution one time during the study.
16329892|NCT00425152|Drug|fluorouracil|
16329893|NCT00425152|Drug|leucovorin calcium|
16329894|NCT00425152|Drug|levamisole hydrochloride|
16329895|NCT00425139|Behavioral|Re-Mission|
16329896|NCT00425126|Drug|Epoetin Alfa|
16329897|NCT00425113|Drug|Metronidazole|
16329898|NCT00425113|Procedure|Blood Draw|
16329899|NCT00425113|Procedure|CT Scan|
16329900|NCT00425113|Procedure|PET Scan|
16329901|NCT00425100|Drug|fesoterodine fumarate|12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
16329902|NCT00425074|Drug|slow release acetyl salicylic acid|150 mg in capsules via oral, during 14 days.
16329903|NCT00425074|Drug|ASA|normal release acetylsalicylic acid
16329904|NCT00425074|Drug|SR-ASA|slow release acetylsalicylic acid 150 mg
16329905|NCT00425061|Biological|IMA-638|SC Injection, 12 weeks
16329906|NCT00425061|Biological|IMA-638|SC Injection, 12 weeks
16329907|NCT00425061|Other|placebo|placebo
16329908|NCT00425048|Procedure|wearing gloves|
16329909|NCT00425035|Drug|Panitumumab (ABX-EGF)|
16329910|NCT00425022|Procedure|thoracoscopy|
16329911|NCT00425009|Drug|Berberine|
16329912|NCT00425009|Drug|Metformin|
16329913|NCT00424983|Drug|Zoledronic acid|
16329914|NCT00424970|Drug|acetazolamide|
16329915|NCT00424944|Biological|GMZ2 (malaria vaccine)|100 micrograms of GMZ2 in each vaccination
16329916|NCT00424944|Biological|GMZ2 malaria vaccine|100 micrograms of GMZ2
16329917|NCT00424944|Biological|Verorab vaccine|Anti-rabies vaccine
16329918|NCT00424931|Drug|JNJ-17216498|50mg one time
16329919|NCT00424931|Drug|JNJ-17216498|10mg one time
16329920|NCT00424931|Drug|Modafinil|200 mg X 2
16329921|NCT00424918|Behavioral|Physical Activity, reduced sedentary behavior|
16329922|NCT00424905|Drug|Bacillus clausii|2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
16329923|NCT00424892|Drug|Desvenlafaxine Sustained Release|
16329924|NCT00424866|Drug|FGF-1|"Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg
~Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg"
16329925|NCT00424866|Drug|Placebo|Vehicle: 0 µg/kg
16329926|NCT00424853|Drug|Docetaxel and cisplatin followed by gemcitabine|docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles
16329927|NCT00424853|Drug|docetaxel and cisplatin followed by gemcitabine|docetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles.
16329928|NCT00424840|Drug|Bortezomib 1.3 mg/m2|"Level I (every 21 day cycle, D8), 1.3 mg/m2:
~Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2
~Level II (every 21 day cycle):
~Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2
~Level III(every 21 day cycle):
~Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2"
16329929|NCT00424840|Drug|Bortezomib 1.6 mg/m2|Level II (every 21 day cycle, D8), 1.6 mg/m2
16329930|NCT00424840|Drug|Bortezomib 1.8 mg/m2|Level III (every 21 day cycle, D8) 1.8 mg/m2
16329931|NCT00424840|Drug|Carboplatin AUC 6|Carboplatin AUC6
16329932|NCT00424840|Drug|Bevacizumab|Bevacizumab 15 mg/kg
16329933|NCT00424840|Drug|Taxotere|Taxotere 70 + G-CSF
16329934|NCT00424827|Drug|Gemcitabine/Fluorouracil with External Beam Radiation|This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
16329935|NCT00424814|Drug|Kaletra (lopinavir/ritonavir)|(200/50 mg x2)x 2/d= 2 pills twice daily
16329936|NCT00424814|Drug|Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)|Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily
16329937|NCT00424801|Drug|Lercanidipine|Individual titration, max. dose 20 mg OD for 8 months
16329938|NCT00424801|Drug|Valsartan|Individual titration, max. dose 160 mg OD for 8 months
16329939|NCT00424801|Drug|Nicorandil|Individual titration, max. dose 20 mg BD for 8 months
16329940|NCT00424801|Drug|Doxazosin|Individual titration, max. dose 4 mg OD for 8 months
16329941|NCT00424801|Drug|Moxonidin|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 0,2 mg OD for 8 months
16329942|NCT00424801|Drug|Pindolol|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 10 mg OD for 8 months
16329943|NCT00424801|Drug|Amiloride, hydrochlorothiazide|Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 1 tbl. OD for 8 months
16329944|NCT00424788|Procedure|Plasma exchange|
16329945|NCT00424788|Drug|natalizumab treatment|
16329946|NCT00424775|Drug|MK0683, vorinostat|vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
16329947|NCT00424762|Drug|rosiglitazone|6 months of treatment of blinded study drug
16329948|NCT00424762|Drug|placebo|blinded treatment with matching placebo
16329949|NCT00424749|Drug|Rituximab|Patients received 4 weekly doses of rituximab 375 mg/m^2.
16329950|NCT00424749|Drug|Prednisone|Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months
16329951|NCT00424736|Procedure|whole body CT scan|
16329952|NCT00424723|Drug|Pemetrexed|Given intravenously over 10 minutes every 21 days (21 days equals one cycle). Subjects will continue to receive pemetrexed as long as their disease does not worsen and they do not experience any serious side effects.
16329953|NCT00424710|Drug|ranibizumab intravitreal injection|liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
16329954|NCT00424697|Drug|placebo|
16329955|NCT00424697|Drug|lorazepam|
16329956|NCT00424697|Drug|GW876008|
16329957|NCT00424684|Procedure|collection of blood sample|
16329958|NCT00424671|Drug|Licarbazepine|
16329959|NCT00424658|Procedure|SAHS diagnosis|
16329960|NCT00424645|Drug|Voraxaze (Glucarpidase)|50 units/kg IV within 12 hours of study eligibility being confirmed.
16329961|NCT00424645|Drug|Placebo|Administered by IV within 12 hours of study eligibility being confirmed.
16329962|NCT00424632|Drug|PF-03814735|1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.
16329963|NCT00424619|Drug|Vitamin D2|50 000 IU vitamin D2, one time bolus dose
16329964|NCT00424619|Drug|Vitamin D2|100 000 IU vitamin D2, one time bolus dose
16329965|NCT00424619|Drug|Placebo|Placebo, 1 time bolus dose
16329966|NCT00424606|Drug|Docetaxel|Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
16329967|NCT00424606|Drug|Epirubicin|Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
16329968|NCT00424606|Drug|Epirubicin|Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
16329969|NCT00424606|Drug|Docetaxel|Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
16329970|NCT00424593|Drug|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
16329971|NCT00424593|Drug|Placebo|every day (QD), by mouth (PO), 13 weeks
16329972|NCT00424580|Drug|Montelukast (10mg) and Desloratadine (5mg)|
16329973|NCT00424567|Procedure|Fracture surgery|
16329974|NCT00424567|Drug|Cultured Bone Marrow Tissue|
16329975|NCT00424554|Drug|temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
~As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion."
16329976|NCT00424541|Drug|SPP100 (aliskiren)|
16329977|NCT00424528|Drug|Arformoterol Tartrate Inhalation Solution|Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.
16329978|NCT00424528|Drug|Tiotropium|Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.
16329979|NCT00424528|Drug|Arformoterol and Tiotropium|Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.
16329980|NCT00424528|Drug|Placebo|Placebo inhalation solution and placebo inhalation powder
16329981|NCT00424515|Drug|Imatinib|Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
16329982|NCT00424502|Drug|rituximab [MabThera/Rituxan]|1g iv on days 1 and 15
16329983|NCT00424502|Drug|Methotrexate|10-25mg po/week
16329984|NCT00424489|Biological|Hematopoietic Stem Cell Transplantation|Autologous Hematopoietic Stem Cell Transplantation
16329985|NCT00424489|Drug|Cyclophosphamide|
16329986|NCT00424489|Drug|ATG (rabbit)|
16329987|NCT00424489|Drug|Mesna|
16329988|NCT00424489|Drug|Methylprednisolone|
16329989|NCT00424489|Drug|G-CSF|
16329990|NCT00424476|Drug|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
16329991|NCT00424476|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
16329992|NCT00424476|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
16329993|NCT00424463|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
16329994|NCT00424463|Drug|Placebo of MCI-186|Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.
16329995|NCT00424450|Procedure|lower limb artery bypass surgery|bypass of severe atherosclerotic vascular lesion
16329996|NCT00424450|Procedure|percutaneous angioplasty (PTA)|PTA of severe atherosclerotic lesion
16329997|NCT00424437|Drug|Inhaled human insulin|
16329998|NCT00424424|Drug|MK0719|
16329999|NCT00424411|Drug|Inhaled human insulin (EXUBERA™)|
16330000|NCT00424398|Drug|Bepreve|sterile ophthalmic solution
16330001|NCT00424398|Drug|Placebo|sterile ophthalmic solution
16330002|NCT00424398|Drug|Bepotastine Besilate|sterile ophthalmic solution
16330003|NCT00424385|Drug|Gleevec + Sorafenib|400 mg Sorafenib every day (QD) 300mg Gleevec QD
16330004|NCT00424372|Drug|pregabalin|Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
16330005|NCT00424346|Drug|Canakinumab|
16330006|NCT00424346|Drug|Placebo|
16330009|NCT00424307|Device|HiResolution Bionic Ear System|
16330010|NCT00424294|Drug|CP-195,543|CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.
16330011|NCT00424294|Drug|celecoxib|Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
16330012|NCT00424294|Drug|Methotrexate|Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
16330013|NCT00424281|Drug|Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability|
16330014|NCT00424268|Drug|Roflumilast|500 µg, once daily, oral administration in the morning
16330015|NCT00424268|Drug|Placebo|once daily
16330016|NCT00424255|Drug|Lapatinib|Dual ErbB1/2 inhibitor
16330017|NCT00424255|Radiation|Chemoradiation|Radiation plus platinum based chemotherapy
16330018|NCT00424255|Other|Placebo|Placebo
16330019|NCT00424242|Drug|Pemetrexed|Orally beginning at 500 mg/m2 every 3 weeks until disease progression
16330020|NCT00424229|Drug|LENALIDOMIDE|
16330021|NCT00424216|Procedure|DC Polarization|
16330022|NCT00424203|Drug|AC regimen|
16330023|NCT00424203|Drug|cyclophosphamide|
16330024|NCT00424203|Drug|doxorubicin hydrochloride|
16330025|NCT00424203|Procedure|adjuvant therapy|
16330026|NCT00424203|Procedure|cognitive assessment|
16330027|NCT00424203|Procedure|management of therapy complications|
16330028|NCT00424203|Procedure|psychosocial assessment and care|
16330029|NCT00424203|Procedure|quality-of-life assessment|
16330030|NCT00424190|Drug|IV Vancomycin plus IV Aztreonam|vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
16330031|NCT00424190|Drug|Ceftaroline|600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
16330032|NCT00424177|Drug|eltrombopag|experimental
16330033|NCT00424164|Drug|lapatinib ditosylate|
16330034|NCT00424164|Drug|tamoxifen citrate|
16330035|NCT00424164|Other|pharmacological study|
16330036|NCT00424151|Drug|Rituximab|
16330037|NCT00424138|Radiation|FDG|
16330038|NCT00424125|Behavioral|Enhanced Pharmacy Care|"Participants randomized to Enhanced Pharmacy Care will have their prescriptions electronically transmitted or faxed to one of the five participating pharmacies.
~Pharmacists will then provide real-time, targeted education around the purpose and use of the new and refilled ICS medications to study participants and their families at each point of contact, including rationale for their use, device teaching, dosage review, and importance of compliance. Families randomized to enhanced care will also be contacted monthly by phone and mail with reminders to fill their controller medications prescriptions and to seek ongoing longitudinal asthma care with their primary care providers."
16330039|NCT00424125|Behavioral|Control|Usual care.
16330040|NCT00424099|Drug|Methylphenidate|5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.
16330041|NCT00424099|Behavioral|Nursing Telephone Intervention|Call from study nurse 3 times weekly to ask about side effects and other symptoms.
16330042|NCT00424099|Drug|Placebo|One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.
16330043|NCT00424099|Behavioral|Non NTI|Non NTI are calls from research staff 3 times weekly.
16330044|NCT00424086|Biological|Inactivated seasonal influenza vaccine (split virus, vero cell derived)|
16330045|NCT00424086|Biological|Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]|
16330046|NCT00424060|Drug|sagopilone|
16330047|NCT00424060|Genetic|fluorescence in situ hybridization|
16330048|NCT00424060|Genetic|gene expression analysis|
16330049|NCT00424060|Other|immunohistochemistry staining method|
16330050|NCT00424060|Other|laboratory biomarker analysis|
16330051|NCT00424060|Other|pharmacological study|
16330052|NCT00424047|Drug|CC-5013 plus dexamethasone|25 mg daily for 21 days every 28 days.
16330053|NCT00424047|Drug|Dexamethasone plus Placebo|Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
16330054|NCT00424034|Drug|GSK1325760A|
16330055|NCT00424021|Drug|ambrisentan|1, 2.5, 5, and 10 mg ambrisentan given orally once daily
16330056|NCT00424008|Drug|Mometasone furoate/formoterol (MF/F) MDI|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
16330057|NCT00424008|Drug|Fluticasone propionate/salmeterol (F/SC) DPI|Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
16330058|NCT00423995|Drug|Loratadine/montelukast combination|
16330059|NCT00423982|Drug|Rifampin-combination therapy|Rifampin 300 mg x 3 po and cloxacillin 2 g x 4 iv for two weeks. Then rifampin 300 mg x 3 po and cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, rifampin 300 mg x 3 po and vancomycin 1 g x 2 iv for 6 weeks.
16330060|NCT00423982|Drug|Monotherapy|Cloxacillin 2 g x 4 iv for two weeks, then cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, vancomycin 1 g x 2 iv for 6 weeks.
16330061|NCT00423969|Drug|Galantamine|
16330062|NCT00423969|Drug|Escitalopram|
16330063|NCT00423956|Procedure|Repairing Induced tooth root resorption by ultrasound|Repairing Induced tooth root resorption by ultrasound
16330064|NCT00423943|Drug|modafinil|200 milligrams daily dose
16330065|NCT00423943|Drug|Placebos|capsule containing placebo
16330066|NCT00423930|Biological|bevacizumab|
16330067|NCT00423930|Drug|cisplatin|
16330068|NCT00423930|Procedure|conventional surgery|
16330069|NCT00423930|Radiation|intensity-modulated radiation therapy|
16330070|NCT00423917|Biological|bevacizumab|
16330071|NCT00423917|Drug|fulvestrant|
16330072|NCT00423904|Behavioral|Brief intervention|
16330849|NCT00418067|Device|Endeavor|Zotarolimus-eluting stent
16330073|NCT00423891|Drug|Entecavir|Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
16330074|NCT00423878|Drug|Risperidone|Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
16330075|NCT00423878|Drug|Olanzapine|Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
16330076|NCT00423878|Drug|Quetiapine|Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
16330077|NCT00423878|Drug|Aripiprazole|Switching medication to aripiprazole for schizophrenia for up to 6 months in study
16330078|NCT00423865|Drug|cisplatin|cisplatin (20 mg/m2 intravenously on Days 1, 8, and 15)
16330079|NCT00423865|Drug|everolimus|escalating doses of daily RAD001 tablets (per oral or via percutaneous gastrostomy tube, Days 1 -21 of a 28-Day Cycle)
16330080|NCT00423865|Genetic|gene expression analysis|Each biopsy specimen will be formalin-fixed and paraffin-embedded for IHC, and analysis of p53 and p21 will follow methods previous reported by our group. The avidin-biotin immunoperoxidase technique will be employed.
16330081|NCT00423865|Other|immunohistochemistry staining method|After the phase 2 recommended dose is established in the phase I portion of the study (Part A), we plan to enroll an additional 6 patients for pharmacodynamic studies (Part B). Entry into Part B requires the patient have tumor tissue which is easily accessible for research biopsy. The patients will be asked to provide written informed consent for the research biopsies. Patients also will be asked to provide written informed consent to allow the use of their tissue for future research studies. The research biopsies are not mandatory for any patient. Patients who do not consent to the research biopsies or who withdraw consent for the research biopsies may still receive RAD001 + cisplatin in the study
16330082|NCT00423865|Other|laboratory biomarker analysis|Laboratory data (complete blood count, comprehensive metabolic panel including magnesium) regarding adverse events will be collected on each cisplatin treatment day. Additional adverse event data will be collected at regularly scheduled clinic visits at which history and physical are performed by the investigator (Cycle 1 - Days 1, 8, 15, and 21. Cycle 2 - Days 1 and 15. Cycle 3 and beyond - Day 1)
16330083|NCT00423865|Other|pharmacological study|For patients in Part A, research bloods for pharmacokinetics are drawn on Day 1 and Day 8.
16330084|NCT00423865|Procedure|biopsy|"Pre-treatment Research Biopsy: Within 14 days prior to treatment, research biopsy (of primary tumor, metastatic deposit, or involved lymph node) will be performed. Baseline labs should be drawn within 14 days of the research biopsy. The biopsy sample will be formalin-fixed and paraffin-embedded for immunohistochemistry. Post-treatment Research Biopsy: Research biopsy (of primary tumor, metastatic deposit, or involved lymph node) will be requested again for Day 15 of Cycle 1, prior to administration of RAD001 and cisplatin on that day."
16330085|NCT00423852|Biological|filgrastim|
16330086|NCT00423852|Drug|carboplatin|
16330087|NCT00423852|Drug|ifosfamide|
16330088|NCT00423852|Drug|paclitaxel|
16330089|NCT00423852|Procedure|autologous hematopoietic stem cell transplantation|
16330090|NCT00423852|Procedure|peripheral blood stem cell transplantation|
16330091|NCT00423839|Biological|MVA85A (Tuberculosis vaccine)|
16330092|NCT00423826|Drug|Busulfan|3 mg/kg intravenously over 3 hours
16330093|NCT00423826|Drug|Cytarabine|Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.
16330094|NCT00423826|Drug|Fludarabine phosphate|25 mg/M2/day IV
16330095|NCT00423826|Drug|mycophenolate mofetil|Orally at the dose of 1 gm every 8 hours.
16330096|NCT00423826|Drug|tacrolimus|0.015 mg/kg IV every 12 hours by continuous infusion.
16330097|NCT00423826|Procedure|allogeneic hematopoietic stem cell transplantation|10 days post drug intervention
16330098|NCT00423826|Procedure|umbilical cord blood transplantation|10 days post drug intervention
16330099|NCT00423826|Radiation|total-body irradiation|10 days post drug intervention
16330100|NCT00423813|Drug|placebo|Oral Solution
16330101|NCT00423813|Drug|Xyrem®|two doses
16330102|NCT00423800|Drug|Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)|"Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
~200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks"
16330103|NCT00423787|Biological|Ragweed MATA MPL|"4 injections of increasing dose strength:
~300 SU/0.5 ml
~700 SU/0.5 ml
~2000 SU/0.5 ml
~6000 SU/0.5 ml"
16330104|NCT00423774|Behavioral|Problem-Solving Education|
16330105|NCT00423761|Drug|midazolam|
16330106|NCT00423761|Drug|GW876008|
16330107|NCT00423748|Drug|ambrisentan|
16330108|NCT00423735|Drug|Dasatinib|Given PO
16330109|NCT00423735|Other|Pharmacological Study|Correlative studies
16330110|NCT00423722|Drug|Saline|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
16330111|NCT00423722|Drug|Saline|100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
16330112|NCT00423709|Procedure|Allogeneic Blood Stem Cell Transplantation|
16330113|NCT00423709|Drug|Fludarabine|
16330114|NCT00423709|Drug|Melphalan|
16330115|NCT00423696|Biological|bevacizumab|
16330116|NCT00423696|Drug|capecitabine|
16330117|NCT00423696|Drug|fluorouracil|
16330118|NCT00423696|Drug|irinotecan hydrochloride|
16330119|NCT00423696|Drug|leucovorin calcium|
16330120|NCT00423683|Drug|Arixtra alone|Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
16330121|NCT00423683|Device|Arixtra + filter|Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
16330122|NCT00423670|Drug|boceprevir (SCH 503034)|200 mg capsules taken as 800 mg orally three times daily (TID)
16330123|NCT00423670|Drug|peginterferon-alfa 2b (PegIntron)|1.5 μg/kg subcutaneously (SC) once weekly (QW)
16330124|NCT00423670|Drug|ribavirin|200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
16330125|NCT00423670|Drug|ribavirin (low-dose)|200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
16330850|NCT00418067|Device|Cypher|Sirolimus-eluting stent
16330126|NCT00423657|Drug|ceftaroline|600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
16330127|NCT00423657|Drug|vancomycin plus aztreonam|vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
16330128|NCT00423657|Drug|Placebo|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
16330129|NCT00423644|Drug|Darinaparson|420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months
16330130|NCT00423631|Behavioral|Standard care and web|A static web site containing cognitive and behavioral self management instructions.
16330131|NCT00423631|Behavioral|Standard Care|Standard care delivered by the primary care provider.
16330132|NCT00423618|Radiation|radiotherapy|radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
16330133|NCT00423605|Drug|Xyrem®|flexible dosing
16330134|NCT00423592|Drug|ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
16330135|NCT00423579|Drug|Ezetimibe/Simvastatin 10/20 mg|1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks
16330136|NCT00423579|Drug|simvastatin 40 mg|1 tablet containing 40 mg of simvastatin per day for 6 weeks
16330137|NCT00423566|Biological|MVA85A (Tuberculosis vaccine)|
16330138|NCT00423540|Drug|Intravenous Infusion of Magnesium Sulfate|See Detailed Description.
16330139|NCT00423527|Drug|levetiracetam|Levetiracetam tablets 500 mg, total daily dose 3000 mg
16330140|NCT00423514|Biological|filgrastim|
16330141|NCT00423514|Drug|clofarabine|
16330142|NCT00423514|Drug|melphalan|
16330143|NCT00423514|Drug|mycophenolate mofetil|
16330144|NCT00423514|Drug|tacrolimus|
16330145|NCT00423514|Drug|thiotepa|
16330146|NCT00423514|Procedure|allogeneic bone marrow transplantation|
16330147|NCT00423514|Procedure|allogeneic hematopoietic stem cell transplantation|
16330148|NCT00423514|Procedure|peripheral blood stem cell transplantation|
16330149|NCT00423501|Drug|Placebo|sc weekly
16330150|NCT00423501|Drug|taspoglutide|20mg sc weekly
16330151|NCT00423501|Drug|taspoglutide|10mg sc every 2 weeks
16330152|NCT00423501|Drug|taspoglutide|5mg sc weekly
16330153|NCT00423501|Drug|taspoglutide|10mg sc weekly
16330154|NCT00423501|Drug|taspoglutide|20mg sc every 2 weeks
16330155|NCT00423488|Drug|Ezetimibe 10 mg|1 x 10-mg tablet, provided as blinded study treatment
16330156|NCT00423488|Drug|Simvastatin 20 mg|1 x 20-mg tablet, provided as open-label study treatment
16330157|NCT00423488|Drug|Ezetimibe Placebo|1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment
16330158|NCT00423488|Drug|Simvastatin 20 mg|1 x 20-mg tablet, provided as blinded study treatment
16330159|NCT00423488|Drug|Simvastatin Placebo|1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment
16330160|NCT00423475|Drug|goserelin acetate|
16330161|NCT00423475|Procedure|adjuvant therapy|
16330162|NCT00423475|Radiation|radiation therapy|
16330163|NCT00423462|Behavioral|Brief dynamic psychotherapy|
16330164|NCT00423449|Drug|vorinostat|Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days
16330165|NCT00423449|Drug|Gemcitabine|Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle
16330166|NCT00423449|Drug|Platinum-based agent|Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.
16330167|NCT00423436|Behavioral|Questionnaire|Questionnaires taking about 30-45 minutes to complete.
16330168|NCT00423436|Behavioral|Interactive Voice Response Telephone System|IVR Only = Phone calls twice weekly, each call lasting less than 5 minutes.
16330169|NCT00423436|Behavioral|IVR Plus Triage|"IVR system will triage, or sort, the symptom data by symptom severity, notifying health care professionals when a symptom is greater than the set threshold limit."
16330170|NCT00423410|Drug|EPC2407 (crinobulin)|IV infusion 1 to 4 hours
16330171|NCT00423397|Biological|PEG-interferon alfa-2a|
16330172|NCT00423397|Drug|gefitinib|
16330173|NCT00423384|Drug|Placebo|Placebo
16330174|NCT00423384|Drug|Ibandronate|I.v.
16330175|NCT00423371|Device|sodium hyaluronate|EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
16330176|NCT00423371|Device|placebo|Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
16330177|NCT00423358|Dietary Supplement|Vitamin D|Ergocalciferol 50,000 IU loading dose then twice monthly for one year
16330178|NCT00423358|Dietary Supplement|placebo|matching placebo
16330179|NCT00423332|Drug|Cediranib|45 mg oral tablet
16330180|NCT00423332|Drug|Cediranib Placebo|oral tablet
16330181|NCT00423319|Drug|Enoxaparin|Subcutaneous, 40 mg, once daily, 5 weeks
16330182|NCT00423319|Drug|Apixaban|Oral tablets, 2.5 mg, twice daily, 5weeks
16330183|NCT00423319|Drug|Enoxaparin-matching placebo|Administered as injection
16330184|NCT00423319|Drug|Apixaban-matching placebo|Administered as oral tablets
16330185|NCT00423306|Drug|Darinaparsin|420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest, for up to 6 months
16330186|NCT00423293|Drug|fluorouracil|1000 mg/m^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.
16330187|NCT00423293|Drug|mitomycin C|10 mg/m^2 intravenous therapy on day 1 and day 29 of radiation therapy.
16330297|NCT00422500|Behavioral|Telephone Interactive System|Automated telephone system call once a week during therapy, rating of severity of symptoms and daily life interference done with numeric key pad. Post therapy is complete, a call every two weeks for up to six months.
16330188|NCT00423293|Radiation|Intensity-modulated radiation therapy|"Prescription dose depends on tumor staging.
~T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions.
~T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions.
~For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes > 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx."
16330189|NCT00423280|Drug|6R-BH4|6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
16330190|NCT00423267|Drug|Posaconazole|Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months
16330191|NCT00423267|Drug|Fluconazole|Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months
16330192|NCT00423254|Biological|PSMA/PRAME|Low dose
16330193|NCT00423254|Biological|PSMA/PRAME|high dose
16330194|NCT00423241|Device|SEMPERFLO Pain Management System|continuous infusion of 0.5% bupivacaine at 2mL per hour
16330195|NCT00423241|Device|ON-Q PainBuster Post-Op Pain Relief System|continuous infusion of 0.5% bupivacaine at 2mL per hour
16330196|NCT00423228|Drug|ZT-1|Patients in the ZT-1 treatment group will receive ZT 1-1 mg capsules administered p.o. daily during the first month of treatment, followed by ZT-1 implants (9 mg) administered s.c. during the second month of treatment, followed by ZT-1 implants (12 mg) administered s.c. every 4 weeks during months 3 to 6 of treatment. Patients in the ZT-1 treatment group will receive dummy donepezil capsules during months 2 to 6 of the treatment period.
16330197|NCT00423228|Drug|Donepezil|Patients in the donepezil treatment group will receive donepezil 5 mg capsules administered p.o. during the first month of treatment, followed by donepezil 10 mg/day during months 2 to 6 of the treatment period. Patients in the donepezil treatment group will also receive s.c. injections of dummy ZT 1 implants every 4 weeks during months 2 to 6 of the treatment period.
16330198|NCT00423215|Drug|Insulin glargine (LANTUS)|"The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day.
~Treatment duration: 4 months."
16330199|NCT00423202|Drug|ambrisentan|
16330200|NCT00423189|Drug|Ranibizumab (Lucentis)|as needed, one intravitreal injection of 0.50mg ranibizumab
16330201|NCT00423189|Drug|0.5mg ranibizumab|as needed, one intravitreal injection of 0.50mg ranibizumab
16330202|NCT00423176|Drug|MFNS and antibiotic|MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
16330203|NCT00423176|Drug|Matching Placebo nasal spray plus antibiotic|Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
16330204|NCT00423163|Drug|micafungin|
16330205|NCT00423163|Drug|voriconazole|
16330206|NCT00423150|Drug|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.
16330207|NCT00423137|Drug|BIBW 2948 BS|
16330208|NCT00423137|Drug|Placebo|
16330209|NCT00423124|Genetic|HSV-TK|Infusion of genetically modified lymphocytes (1x10^6-1x10^7 c/kg): first at +21-+49 days after HSCT; in absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.
16330210|NCT00423098|Drug|Mycophenolate sodium|Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
16330211|NCT00423098|Drug|Prednisone|Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
16330212|NCT00423098|Drug|Methylprednisolone|All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
16330213|NCT00423085|Drug|Rivastigmine transdermal patch|"Rivastigmine transdermal patch was provided in the following sizes and doses:
~2.5 cm^2 (4.5 mg), 5 cm^2 (9 mg), 7.5 cm^2 (13.5 mg), and 10 cm^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day."
16330214|NCT00423085|Drug|Placebo|Placebo transdermal patch was provided in the following sizes: 2.5 cm^2, 5 cm^2, 7.5 cm^2 and 10 cm^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.
16330215|NCT00423059|Drug|bevacizumab|
16330216|NCT00423046|Biological|GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)|Three doses administered intramuscularly at months 0, 1 and 6
16330217|NCT00423046|Biological|Gardasil ® (Merck & Co. Inc)|Three doses administered intramuscularly at months 0, 2 and 6
16330218|NCT00423046|Biological|Placebo|One dose administered intramuscularly at month 1 to maintain blinding
16330219|NCT00423046|Biological|Placebo|One dose administered intramuscularly at month 2 to maintain blinding
16330220|NCT00423020|Drug|Erythropoietin|
16330221|NCT00423007|Drug|Bromfenac|
16330222|NCT00423007|Drug|Placebo|
16330223|NCT00422994|Drug|ropinirole dosing for up to 28 days|
16330224|NCT00422981|Drug|AL-108|5 mg QD
16330225|NCT00422981|Drug|AL-108|15 mg BID
16330226|NCT00422981|Drug|Placebo|Placebo
16330227|NCT00422968|Device|Percutaneous coronary intervention|Using silorimus eluting stent
16330228|NCT00422968|Procedure|coronary artery bypass graft|coronary artery bypass graft
16330229|NCT00422955|Drug|rosiglitazone|
16330230|NCT00422942|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15
16330231|NCT00422942|Drug|Methotrexate|10-25mg po weekly
16330232|NCT00422916|Behavioral|behavioral intervention|
16330233|NCT00422903|Drug|lapatinib|1500 mg administered orally daily
16330234|NCT00422903|Drug|letrozole|2.5 mg administered orally daily
16330235|NCT00422903|Other|placebo|1500 mg administered orally daily
16330236|NCT00422890|Drug|5-Azacytidin|in case of decreasing CD34 chimerism
16330237|NCT00422877|Drug|Taxoprexin|DHA-paclitaxel
16332223|NCT00407862|Drug|Losartan 50 mg|
16330238|NCT00422864|Drug|oxaliplatin|"Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU).
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1."
16330239|NCT00422864|Drug|fluorouracil|"Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
~Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy, Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1."
16330240|NCT00422864|Drug|leucovorin|Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
16330241|NCT00422864|Procedure|External beam radiotherapy|Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy, Weeks 8-10: as per Weeks 3-5
16330242|NCT00422838|Procedure|fine-needle aspiration biopsy|aspiration of intrahepatic cells
16330243|NCT00422825|Drug|imatinib|
16330244|NCT00422812|Drug|Inhaled Placebo|Inhaled Staccato Placebo
16330245|NCT00422812|Drug|Inhaled PCZ 5 mg|Inhaled Staccato Prochlorperazine 5 mg
16330246|NCT00422812|Drug|Inhaled PCZ 7.5 mg|Inhaled Staccato Prochlorperazine 7.5 mg
16330247|NCT00422812|Drug|Inhaled PCZ 10 mg|Inhaled Staccato Prochlorperazine 10 mg
16330248|NCT00422799|Drug|Bortezomib|Once weekly for 3 weeks
16330249|NCT00422799|Drug|Rituximab|Intravenously once a week for the first and fourth weeks of a cycle
16330250|NCT00422786|Drug|CAP-232|Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
16330251|NCT00422773|Drug|Cetuximab|Dose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg/m² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg/m² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg/m² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg/m² 400 400 400 400 5-FU Infusion 46.0 mg/m² 3200 3200 3200 3200
16330252|NCT00422747|Drug|beclomethasondipropionate|2 x 100 ug dd for two months, via aerochamber
16330253|NCT00422734|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
16330254|NCT00422734|Drug|Placebo|placebo tablet taken by mouth once a day for 12 weeks
16330255|NCT00422721|Procedure|realization of a family tree|
16330256|NCT00422721|Procedure|refractometry|
16330257|NCT00422721|Procedure|evaluation of the presence of a nystagmus|
16330258|NCT00422721|Procedure|ocular behavior|
16330259|NCT00422721|Procedure|test of baby vision|
16330260|NCT00422721|Procedure|test of keenness|
16330261|NCT00422721|Procedure|reading test|
16330262|NCT00422721|Procedure|visual field|
16330263|NCT00422721|Procedure|color vision|
16330264|NCT00422721|Procedure|electroretinographical activity|
16330265|NCT00422721|Procedure|biomicroscopical test|
16330266|NCT00422721|Procedure|retinal imaging|
16330267|NCT00422721|Procedure|retinal autofluorescence|
16330268|NCT00422721|Procedure|genotyping|
16330269|NCT00422708|Procedure|Local anesthesia|
16330270|NCT00422682|Drug|bsi-201 + topotecan|21 day cycle
16330271|NCT00422682|Drug|bsi-201 + temozolomide|28 day cycle
16330272|NCT00422682|Drug|bsi-201 + gemcitabine|28 day cycle
16330273|NCT00422682|Drug|bsi-201 + carboplatin/paclitaxel|21 day cycle
16330274|NCT00422669|Device|Medtronic Dual-Chamber Pacemaker|A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
16330275|NCT00422669|Device|Medtronic SelectSecure 3830 Lead|Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
16330276|NCT00422656|Drug|Perifosine|
16330277|NCT00422643|Drug|Sodium hyaluronate (hyaluronic acid)|
16330278|NCT00422630|Behavioral|The DASH diet|The DASH diet was originally conceived as the optimal diet for individuals with hypertension, based on epidemiologic and clinical trial data suggesting a beneficial effect of plant-based diets on blood pressure It is a diet rich in fruits, vegetables, whole grains, and low-fat dairy products, with moderate amounts of nuts, legumes, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet
16330279|NCT00422630|Behavioral|The low glycemic Index Diet|The carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets
16330280|NCT00422630|Behavioral|Reduced calorie American Diet|The reduced-calorie diets will provide at least the Recommended Daily Allowance (RDA) for protein (0.8 g/kg/day).
16330281|NCT00422617|Drug|Alefacept (Amevive)|
16330282|NCT00422604|Drug|salmeterol|
16330283|NCT00422604|Drug|tiotropium|
16330284|NCT00422604|Drug|GSK233705|
16330285|NCT00422591|Drug|Cytarabine|1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
16330286|NCT00422591|Drug|Idarubicin|12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
16330287|NCT00422578|Drug|tadalafil|
16330288|NCT00422565|Device|Endeavor, Medtronic|Zotarolimus-eluting stent
16330289|NCT00422565|Device|Cypher, Cordis|Sirolimus-eluting stent
16330290|NCT00422565|Device|Taxus Liberte, Boston Scientific|Paclitaxel-eluting stent
16330291|NCT00422552|Drug|Indacaterol (QAB149)|
16330292|NCT00422539|Drug|70% trichloroacetic acid|
16330293|NCT00422526|Drug|Micronised progesterone (Utrogestan)|
16330294|NCT00422513|Drug|methoxy polyethylene glycol-epoetin beta|120-360 micrograms intravenous (iv) monthly, starting dose
16330295|NCT00422513|Drug|Epoetin alfa|As prescribed, iv, 3 times weekly
16330296|NCT00422500|Behavioral|Questionnaire|Surveys about symptoms, mood, and quality of life.
16332383|NCT00406458|Other|Normal Saline|
16330298|NCT00422500|Other|Blood Samples|For participating patients, 3 additional tablespoons of blood drawn at the beginning of each chemotherapy treatment (before treatment starts) and at the beginning of each cycle of treatment.
16330299|NCT00422487|Drug|MBX-2044|MBX-2044 1.5 mg one capsule daily for 14 days
16330300|NCT00422487|Drug|MBX-2044|MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
16330301|NCT00422487|Drug|MBX-2044|MBX-2044 15 mg one capsule daily for 14 days
16330302|NCT00422487|Drug|MBX-2044|MBX-2044 30 mg two 15 mg capsules daily for 14 days
16330303|NCT00422487|Drug|MBX-2044|MBX-2044 60 mg one capsule daily for 14 days
16330304|NCT00422487|Drug|MBX-2044|MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
16330305|NCT00422487|Drug|Placebo for MBX-2044|Placebo Intervention
16330306|NCT00422461|Drug|placebo|placebo, oral, tablets, once daily, for 28 days
16330307|NCT00422461|Drug|PF-00489791|PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days
16330308|NCT00422461|Drug|PF-00489791|PF-00489791 4 mg, oral, tablets, once daily, for 28 days
16330309|NCT00422461|Drug|PF-00489791|PF-00489791 10 mg, oral, tablets, once daily, for 28 days
16330310|NCT00422448|Genetic|To test the frequency of BRAF and NRAS mutations among nevi|Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations
16330311|NCT00422435|Device|CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter|Paclitaxel-Eluting Coronary Stent
16330312|NCT00422422|Drug|Brivaracetam|"Oral solution
~Evaluation period (3 weeks up-titration):
~For subjects ≥8 years:
~~0.4 mg/kg bid for Week 1
~~0.8 mg/kg bid for Week 2
~~1.6 mg/kg bid for Week 3
~For subjects <8 years:
~~0.5 mg/kg bid for Week 1
~~1.0 mg/kg bid for Week 2
~~2.0 mg/kg bid for Week 3
~Down-titration period (up to 2 weeks):
~For subjects ≥8 years:
~~0.8 mg/kg bid for Week 4
~~0.4 mg/kg bid for Week 5
~For subjects <8 years:
~~1.0 mg/kg bid for Week 4
~~0.5 mg/kg bid for Week 5"
16330313|NCT00422409|Procedure|Endoscopic stenting|
16330314|NCT00422396|Drug|Fenofibrate (drug)|
16330315|NCT00422383|Drug|rituximab [MabThera/Rituxan]|500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
16330316|NCT00422383|Drug|rituximab [MabThera/Rituxan]|500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
16330317|NCT00422383|Drug|rituximab [MabThera/Rituxan]|1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
16330318|NCT00422370|Device|lipid based additives based on vegetable oil & lecithin|
16330319|NCT00422357|Drug|Urtica Dioica (Tea bag)|
16330320|NCT00422344|Drug|RAD001, Sunitinib|Patients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs
16330321|NCT00422331|Drug|Lithium Carbonate Capsule|
16330322|NCT00422318|Drug|Benzbromarone (drug)|
16330323|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL dose, intramuscular (IM)
16330324|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL dose, IM
16330325|NCT00422292|Biological|Meningococcal Polysaccharide Diphtheria Conjugate Vaccine|0.5 Ml dose, IM
16330326|NCT00422292|Biological|Measles, Mumps, Rubella and Varicella|0.5 mL dose, SC
16330327|NCT00422279|Device|Nobel Replace Tapered Groovy|Bone inductive implant placed in supralveoral position or extraction site
16330328|NCT00422266|Drug|Omega 3 fatty acids and plant sterol enriched drink|
16330329|NCT00422266|Dietary Supplement|Omega 3 fatty acids and plant sterols|Capsules and Yoghurt based minidrink
16330330|NCT00422253|Behavioral|dietary intervention|
16330331|NCT00422240|Drug|Adapalene/Benzoyl Peroxide|
16330332|NCT00422227|Drug|Etanercept , Methotrexate|"Etanercept: 25 mg twice weekly over 16 weeks, SC
~Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO"
16330333|NCT00422227|Drug|Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide|"Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
~Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
~Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
~Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily"
16330334|NCT00422214|Drug|Quetiapine fumarate (Seroquel) SR|
16330335|NCT00422201|Drug|Mifepristone|Singe dose
16330336|NCT00422188|Drug|Deoxycholic Acid Injection|Administered via intralipomal injection.
16330337|NCT00422188|Drug|Placebo|Administered via intralipomal injection.
16330338|NCT00422175|Drug|BAF 312|
16330339|NCT00422162|Drug|Duloxetine hydrochloride|60 mg once or twice a day, by mouth
16330340|NCT00422162|Drug|Placebo|placebo capsule by mouth
16330341|NCT00422149|Drug|SUBLIVAC® Grasses/Placebo treatment|SUBLIVAC® Grasses/Placebo treatment
16330342|NCT00422149|Drug|SUBLIVAC® Grasses treatment|SUBLIVAC® Grasses treatment
16330343|NCT00422149|Drug|Placebo treatment|Placebo treatment
16330344|NCT00422123|Drug|Quetiapine fumarate (Seroquel) SR|
16330345|NCT00422110|Drug|Seletracetam|
16330346|NCT00422097|Drug|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330347|NCT00422097|Drug|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330395|NCT00421824|Drug|Oxaliplatin, capecitabine|OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery
16330851|NCT00418067|Device|Taxus Liberte|Paclitaxel-eluting stent
16330348|NCT00422097|Drug|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330349|NCT00422097|Drug|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330350|NCT00422097|Drug|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330351|NCT00422097|Drug|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
16330352|NCT00422097|Drug|Ixabepilone, 25 mg, with famotidine|Participants crossed over from Cycle 1 to receive famotidine, 40 mg, in an oral dose given 2 hours before ixabepilone, 25 mg, on Day 1 of Cycle 2 only.
16330353|NCT00422097|Drug|Ixabepilone, 25 mg, with food|Participants consume a low-fat meal starting 30 minutes before dose administration on Day 1 of Cycle 2. Food consumed within 30 minutes. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
16330354|NCT00422084|Drug|Pyronaridine artesunate|Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)
16330355|NCT00422084|Drug|Coartem® (artemether lumefantrine)|AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)
16330356|NCT00422058|Drug|liraglutide|Injected s.c. (under the skin) once daily
16330357|NCT00422058|Drug|orlistat|120 mg capsule. Administered thrice daily
16330358|NCT00422058|Drug|placebo|Injected s.c. (under the skin) once daily
16330359|NCT00422045|Device|Low Level Laser Therapy|Low Level Laser Therapy done after surgery.
16330360|NCT00422032|Drug|Clofarabine|"Group A: 15 mg/m^2 IV over 1 hour daily for 5 days
~Group B: 30 mg/m^2 IV over 1 hour daily for 5 days"
16330361|NCT00422019|Drug|AMG 102 at 10 mg/kg|AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
16330362|NCT00422019|Drug|AMG 102 at 20 mg/kg|AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
16330363|NCT00422006|Procedure|biopsy of muscle, of liver, and of adipose tissue|biopsy of muscle, of liver, and of adipose tissue
16330364|NCT00422006|Procedure|clamp euglycemic - hyperglycemic|clamp euglycemic-hyperglycemic
16330365|NCT00422006|Behavioral|diet|diet
16330366|NCT00422006|Other|biopsies for biological and genetic analyses|biopsies for biological and genetic analyses
16330367|NCT00421993|Drug|Adapalene/Benzoyl Peroxide|Topical Gel, One application daily in the evening for 12 weeks
16330368|NCT00421993|Drug|Adapalene|Topical Gel,One application daily in the evening for 12 weeks
16330369|NCT00421993|Drug|Benzoyl Peroxide|Topical Gel, one application daily in the evening for 12 weeks
16330370|NCT00421993|Drug|Topical Gel Vehicle|Topical Gel Vehicle,one application daily in the evening for 12 weeks
16330371|NCT00421980|Drug|Etanercept|
16330372|NCT00421967|Drug|Ropivacaine, Ketorolac, adrenaline|Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac
16330373|NCT00421967|Drug|Ropivacaine Ketorolac|Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg
16330374|NCT00421954|Drug|Ziprasidone|subjects will use ziprasidone
16330375|NCT00421941|Procedure|Tube feeding|
16330376|NCT00421928|Drug|oxycodone|10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
16330377|NCT00421928|Drug|placebo|matching placebo twice a day (BID) during 15 weeks
16330378|NCT00421928|Drug|tapentadol (CG5503)|50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
16330379|NCT00421915|Drug|Enbrel (etanercept)|
16330380|NCT00421902|Procedure|Acupuncture|Patients will be have acupuncture (with electro stimulation)
16330381|NCT00421889|Drug|belinostat|
16330382|NCT00421889|Drug|Paclitaxel|
16330383|NCT00421889|Drug|Carboplatin|
16330384|NCT00421876|Behavioral|multifactorial continued educational - behavioural programme|
16330385|NCT00421863|Drug|Triatec 10 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330386|NCT00421863|Drug|Triatec HCT 5|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330387|NCT00421863|Drug|Lasix 25|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330388|NCT00421863|Drug|Micardis 80 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330389|NCT00421863|Drug|Micardis plus 80/12.5|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330390|NCT00421863|Drug|Catapresan TTS 2|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330391|NCT00421863|Drug|Norvasc 10 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330392|NCT00421863|Drug|Triatec 5 mg|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330393|NCT00421863|Drug|Pluscor|Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
16330394|NCT00421850|Behavioral|UNITED Planned Care|
16330396|NCT00421824|Drug|Oxaliplatin, capecitabine|XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
16330397|NCT00421811|Drug|ADH-1|4 gm IV Days 1 and 8
16330398|NCT00421811|Drug|melphalan|By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
16330399|NCT00421785|Drug|Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeks.|
16330400|NCT00421759|Device|Vibrating Insoles|Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other.
16330401|NCT00421746|Drug|Piboserod|
16330402|NCT00421733|Drug|Zemplar (paricalcitol ) capsules|Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
16330403|NCT00421733|Drug|Zemplar (paricalcitol) capsules|Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
16330404|NCT00421733|Drug|Placebo|Group 1 - Placebo once daily (two placebo capsules once daily)
16330405|NCT00421720|Drug|Sufentanil|
16330406|NCT00421720|Drug|Remifentanil|
16330407|NCT00421707|Drug|GW876008|
16330408|NCT00421707|Other|Placebo|
16330409|NCT00421694|Drug|Bicalutamide|
16330410|NCT00421681|Behavioral|Fit and Strong! Exercise Program|Fit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.
16330411|NCT00421668|Drug|Zinc|zinc
16330412|NCT00421668|Drug|Multivitamins|Vitamins C, E, B1, B2, niacin, B6, folate and B12
16330413|NCT00421668|Drug|Placebo|Placebo
16330414|NCT00421655|Drug|Grazax|Tablets 75,000 SQT and matching placebo. One tablet daily.
16330415|NCT00421642|Drug|Adalimumab|The loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly.
16330416|NCT00421629|Behavioral|After-sales service and supportive supervision (AfterSS)|
16330417|NCT00421629|Behavioral|Prospective reimbursement (PR)|
16330418|NCT00421629|Behavioral|Both (AfterSS and PR)|
16330419|NCT00421616|Behavioral|High protein diet study|
16330420|NCT00421603|Drug|Adderall-XR and Topiramate|Adderall-XR 60mg/day and Topiramate 300mg/day
16330421|NCT00421603|Drug|Placebo|Placebo
16330422|NCT00421590|Drug|SMC021|
16330423|NCT00421564|Drug|DBT-Danggui Buxue Tang|
16330424|NCT00421551|Drug|Darunavir|during the 48 first weeks of the trial, (2x300mg) twice a day between W48 and W96, (2x400mg) once a day
16330425|NCT00421551|Drug|ritonavir|during the first 48 weeks, 100mg twice a day between W48 and W96, 100mg once a day
16330426|NCT00421538|Drug|nadroparine calcium|Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.
16330427|NCT00421538|Drug|Placebo|Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks
16330428|NCT00421525|Biological|milatuzumab|twice weekly dosing for 4 weeks, total of 8 doses
16330429|NCT00421512|Drug|Bevacizumab and Sunitinib|On Cycle 1, Day 0, patients will begin treatment with bevacizumab. Sunitinib will begin on Day 1. The starting dose for sunitinib will be 25mg orally daily. sunitinib will be given in a four weeks on-two weeks off schedule. Bevacizumab will begin on Day 0 and will be administered every two weeks at 10mg/kg. A cycle of therapy is 6 weeks. The sunitinib dose escalation portion of the trial will be performed to determine the MTD of sunitinib given in combination with bevacizumab. Once the MTD has been determined, 10 additional patients will be treated at the MTD of sunitinib in combination with bevacizumab.
16330430|NCT00421499|Drug|dark chocolate|
16330431|NCT00421486|Procedure|Oral swabs for HPV-typing and high-risk HPV-determination|Oral swabs for HPV-typing and high-risk HPV-determination
16330432|NCT00421473|Drug|Atovaquone / Proguanil|
16330433|NCT00421460|Drug|Testosterone Undecanoate,1000mg|duration for 4 injections
16330434|NCT00421447|Drug|Anastrozole|Group of women with breast cancer
16330435|NCT00421434|Drug|Nitazoxanide|One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
16330436|NCT00421434|Biological|Peginterferon alfa-2a|Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
16330437|NCT00421434|Biological|Peginterferon alfa-2a|Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
16330438|NCT00421434|Drug|Ribavirin|Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
16330439|NCT00421434|Drug|Ribavirin|Oral ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.
16330440|NCT00421421|Drug|Dutasteride|
16330441|NCT00421408|Dietary Supplement|Whey protein supplement|40-g whey protein supplement daily for 18 months
16330442|NCT00421408|Dietary Supplement|Placebo|Placebo supplement daily for 18 months
16330443|NCT00421395|Biological|90Y-hLL2|weekly dosing for either 2 or 3 weeks
16330444|NCT00421369|Drug|sertraline|
16330445|NCT00421369|Drug|triiodothyronine (T3)|
16330446|NCT00421369|Drug|reboxetine|
16330447|NCT00421343|Drug|alendronate with cholecalciferol|alendronate 70mg /cholecalciferol 2800IU orally once weekly
16330448|NCT00421343|Drug|calcium carbonate with cholecalciferol|calcium carbonate 500mg /cholecalciferol 200IU orally twice daily
16330449|NCT00421343|Behavioral|Falls prevention measures|personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications
16330450|NCT00421330|Procedure|Open Aneurysm Repair|
16330451|NCT00421330|Procedure|Endovascular Aneurysm Repair|
16330452|NCT00421317|Drug|Imatinib|800 mg/day until disease progression or toxicity
16330453|NCT00421304|Biological|Motavizumab|A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.
16330454|NCT00421304|Other|Placebo|A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.
16330456|NCT00421278|Drug|MK0633|Single dose MK0633 100mg po in the fed state administered during a 4-wk study.
16330457|NCT00421252|Drug|clopidogrel 600 mg|Clopidogrel load > 2hrs pre-angiography
16330458|NCT00421252|Device|arterial access sheath|randomize to 5Fr vs 6Fr
16330459|NCT00421226|Drug|ACZ885|
16330460|NCT00421213|Drug|Darinaparsin|300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
16330461|NCT00421200|Drug|Hemospan (MP4OX)|250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers
16330462|NCT00421200|Drug|Voluven (HES 130/0.4)|250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers
16330463|NCT00421187|Drug|Liposomal amphotericin B (AmBisome®)|
16330464|NCT00421187|Drug|Liposomal amphotericin B (AmBisome®)|
16330465|NCT00421174|Drug|Etanercept|Etanercept will be given eight doses of study drug over a 4-week period. The initial dose of etanercept will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated.
16330466|NCT00421174|Drug|Placebo plus corticosteroid|"Patients will receive a total of eight doses of placebo over a 4-week period. The initial dose of placebo will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. The placebo will be the inert diluent used for the etanercept formulation.
~Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated."
16330467|NCT00421161|Drug|olive oil and omega 3 in a combined cream|
16330468|NCT00421148|Drug|Sugammadex 0.5 mg/kg|IV infusion
16330469|NCT00421148|Drug|Sugammadex 1 mg/kg|IV infusion
16330470|NCT00421148|Drug|Sugammadex 2 mg/kg|IV infusion
16330471|NCT00421148|Drug|Sugammadex 4 mg/kg|IV infusion
16330472|NCT00421148|Drug|Placebo|IV infusion
16330473|NCT00421148|Drug|Rocuronium bromide|IV infusion
16330474|NCT00421135|Drug|ZIO-201|ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.
16330475|NCT00421122|Drug|budesonide/formoterol (Symbicort)|inhalation therapy
16330476|NCT00421122|Drug|budesonide (Pulmicort)|inhalation
16330477|NCT00421122|Drug|terbutaline sulfate (Bricasol)|inhalation therapy
16330478|NCT00421109|Drug|Bilastine|Encapsulated 20 mg Tablet. Once daily for 28 days
16330479|NCT00421109|Drug|Levocetirizine|Encapsulated 5 mg tablet. Once daily for 28 days
16330480|NCT00421109|Drug|Placebo|Encapsulated tablet. Once daily for 28 days
16330481|NCT00421096|Drug|Gemcitabine|125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
16330482|NCT00421096|Procedure|Radiotherapy|"45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
~+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area"
16330483|NCT00421096|Drug|Cisplatin|40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
16330484|NCT00421083|Drug|tadalafil|
16330485|NCT00421070|Procedure|Massage therapy|A qualified massage therapist will administer a 20-minute standard massage procedure with the client sitting fully clothed in a special massage chair. The massage therapy session will consist of ; 1) long, broad stroking with light-moderate pressure to the back, compression to the back (parallel to spine) from the shoulders to base of spine, trapezius squeeze, finger pressure on the shoulder; 2) arms dropped to the side with arms kneaded from shoulder to lower arm and pressing down on upper and lower arms; 3) entire hands massaged and pulling of fingers, light kneading to area of cervical vertebrae, pressing down on trapezius with finger pressure and squeezing continuing down the arms.
16330486|NCT00421057|Behavioral|Combined Strength Training and Functional Endurance Exercise|Participants will be taught to stretch a Theraband as far as your arms or legs can stretch and the proper posture for walking for exercise. The Estimated Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test will be performed to check your level of fatigue and physical ability.
16330487|NCT00421057|Behavioral|Questionnaire|Questionnaires taking approximately 30 minutes total to complete.
16330488|NCT00421044|Drug|Patupilone/EPO906|
16330489|NCT00421031|Drug|DVS-233 SR|
16330490|NCT00421018|Drug|Single corticosteroid inhalers and Singulair|Treatment steps according to preset algorithm
16330491|NCT00421005|Drug|fluvastatin|Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
16330492|NCT00420992|Drug|ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)|capsules, up to 80 mg bid
16330493|NCT00420992|Drug|Placebo|capsules, bid
16330494|NCT00420953|Drug|Cordarone|
16330495|NCT00420940|Device|Juvent 1000 Dynamic Motion Therapy (DMT) Platform|Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
16330496|NCT00420940|Device|Juvent 1000 Dynamic Motion Therapy (DMT) Platform|Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
16330497|NCT00420927|Biological|adalimumab|Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
16330498|NCT00420927|Drug|methotrexate|Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.
16330499|NCT00420927|Biological|placebo|Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
16330500|NCT00420914|Procedure|low dose of 2.25 x 10^11 platelets/transfusion (range 1.5 to 2.9)|
16330501|NCT00420901|Drug|sildenafil|
16330502|NCT00420888|Drug|ABR-217620/naptumomab estafenatox|10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
16330503|NCT00420888|Drug|IFN-alpha|3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
16330560|NCT00420433|Procedure|Skeletal Scintigraphy|Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
16330561|NCT00420433|Procedure|Radiography|Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
16330852|NCT00418054|Drug|Nitazoxanide plus peginterferon alfa-2b|
16330853|NCT00418054|Drug|Peginterferon alfa-2b|
16330504|NCT00420875|Device|TOPAZ MicroDebrider|The TOPAZ MicroDebrider will be used for patients that fail conservative care. Under sterile conditions in the operating room, patients will be given intravenous sedation (drugs that make you sleepy and unaware of your surroundings) in a hand vein and local anesthetic (drugs to numb the area where the surgical procedure will be done). Depending on the technique used the study doctor may or may not make an incision (cut) about 1 inch long on the side of your foot to expose your tendon. If the study doctor chooses to use the percutaneous method, an incision will not be made. The study doctor will put the tip of the TOPAZ MicroDebrider device (which is about 1/16th of an inch long) into the tendon. A current of energy will be applied on and around the tendon. Steri strips will be placed on the skin to close the area treated.
16330505|NCT00420862|Procedure|Spiral Computed Tomography|
16330506|NCT00420849|Drug|Lenalidomide|Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.
16330507|NCT00420849|Drug|Dexamethasone|Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
16330508|NCT00420836|Drug|Tobramycin|
16330509|NCT00420823|Drug|Taurine 4g|
16330510|NCT00420810|Drug|MK0928 / Duration of Treatment : 8 Weeks|
16330511|NCT00420797|Drug|10% Phenylephrine hydrochloride gel|
16330512|NCT00420784|Drug|Telaprevir|tablet
16330513|NCT00420784|Drug|Ribavirin|tablet
16330514|NCT00420784|Drug|Pegylated Interferon Alfa 2a|Solution for injection
16330515|NCT00420784|Drug|Matching Placebo|Tablet
16330516|NCT00420771|Drug|Gabapentin|For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsules taken 3 times per day for 3 days, then one 400 mg Gabapentin capsule taken 3 times per day for 4 days. Placebo study medication appears identical to active medication and is prescribed with an identical dosing schedule.
16330517|NCT00420771|Drug|Placebo|placebo comparator appears identical to active medication and is prescribed with an identical dosing schedule with a maximum dose of 400mg taken three times per day
16330518|NCT00420758|Dietary Supplement|Food supplement: fortified spread|Provision of fortified spread
16330519|NCT00420758|Dietary Supplement|Food supplement: maize-soy flour|Provision of corn-soy blend (maize-soy flour)
16330520|NCT00420745|Biological|Rotarix™|Two-dose oral vaccination.
16330521|NCT00420745|Biological|Placebo|Two-dose oral administration
16330522|NCT00420732|Biological|HyperAcute-Lung Cancer Vaccine|300 million cells given intradermally every 3 weeks for up to a total of 12 vaccinations
16330523|NCT00420719|Device|Intramuscular diaphragm electrodes|Conditioning of the diaphragm
16330524|NCT00420706|Drug|SCA-136|
16330525|NCT00420693|Drug|sevoflurane|
16330526|NCT00420680|Drug|Sugammadex|Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium
16330527|NCT00420680|Drug|Sugammadex|Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.
16330528|NCT00420680|Drug|Placebo|Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium
16330529|NCT00420667|Drug|Enoxaparin|
16330530|NCT00420654|Drug|Growth Hormone|1.25 mg, 6 months
16330531|NCT00420654|Drug|Placebo|Equivalent to 1.25 mg, 6 months
16330532|NCT00420654|Other|Healthy controls|Healthy controls
16330533|NCT00420641|Drug|GSK372475|GSK372475 1.0-1.5 mg/day
16330534|NCT00420641|Drug|Paroxetine|Paroxetine 20-30 mg/day
16330535|NCT00420641|Other|Placebo|Placebo to Match
16330536|NCT00420628|Drug|loteprednol etabonate/tobramycin opthalmic suspension|Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
16330537|NCT00420628|Drug|vehicle|topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
16330538|NCT00420615|Drug|Patupilone and Omeprazole|
16330539|NCT00420615|Drug|Patupilone + Midalzolam|
16330540|NCT00420602|Dietary Supplement|Over the counter DHA/EPA dietary supplementation|1000 mg/day DHA/EPA
16330541|NCT00420589|Drug|taranabant|taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
16330542|NCT00420589|Drug|Comparator: placebo|Placebo capsules once daily. Treatment for 52 weeks
16330543|NCT00420576|Drug|DBT-Danggui Buxue Tang|Herbal Combination of Danggui (Radix Angelicae Sinensis) and Huangqi (Radix Astragali)in granules form, in 3 different dosage 6g/3g/1.5g, once time per day for 3 Months treatment
16330544|NCT00420563|Drug|CYCLOPHOSPHAMIDE|50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
16330545|NCT00420563|Drug|MEGESTROL|320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
16330546|NCT00420550|Behavioral|Relaxation Response using Guided Imagery|
16330547|NCT00420537|Drug|cyclosporine|cyclosporine trough levels between 100 and 150
16330548|NCT00420537|Drug|cyclosporine|cyclosporine trough levels between 40 and 90 ng/ml
16330549|NCT00420537|Drug|Mycophenolate mofetil|mycophenolate with low doses
16330550|NCT00420537|Drug|Everolimus|
16330551|NCT00420524|Drug|Patupilone/EPO906|
16330552|NCT00420511|Drug|Sitagliptin|sitagliptin 100 mg once a day
16330553|NCT00420511|Drug|Placebo|placebo once a day
16330554|NCT00420511|Drug|metformin|metformin 1000 mg twice a day (bid) by mouth (po)
16330555|NCT00420498|Drug|Atomoxetine (Strattera™)|
16330556|NCT00420485|Drug|gimatecan|
16330557|NCT00420472|Drug|mycophenolate mofetil [CellCept]|
16330558|NCT00420459|Drug|Aripiprazole|All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.
16330559|NCT00420446|Behavioral|Adjusted diet|
16330854|NCT00418028|Drug|Capecitabine|
16330562|NCT00420433|Procedure|CT Scan|CT scan will include your chest, abdomen, and pelvis. Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
16330563|NCT00420420|Drug|MK0249|MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.
16330564|NCT00420420|Drug|Comparator: Placebo (unspecified)|MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period
16330565|NCT00420407|Drug|normal saline control|no vasopressin added to bolus or 5 hour continuous infusion
16330566|NCT00420407|Drug|vasopressin|vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
16330567|NCT00420394|Procedure|Chemotherapy|
16330568|NCT00420394|Procedure|surgery|
16330569|NCT00420394|Procedure|radiotherapy|
16330570|NCT00420381|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until progressive disease
16330571|NCT00420368|Dietary Supplement|No food supplement|
16330572|NCT00420368|Dietary Supplement|Food supplement: fortified spread|
16330573|NCT00420368|Dietary Supplement|Food supplement: maize-soy flour|
16330574|NCT00420355|Drug|atazanavir|Atazanavir 300 mg daily on Days 6-12.
16330575|NCT00420355|Drug|lopinavir/ritonavir|Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.
16330576|NCT00420342|Drug|Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)|SH K 00641 A -Active study medication encapsulated tablet
16330577|NCT00420342|Drug|Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)|SH K 00641 B - Active study medication encapsulated tablet
16330578|NCT00420342|Drug|SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)|Active control encapsulated tablet
16330579|NCT00420316|Biological|Rotarix (primary vaccination study)|GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
16330580|NCT00420316|Biological|Placebo (primary vaccination study)|Two liquid oral doses of placebo
16330581|NCT00420303|Drug|Etanercept|50 mg injection once weekly
16330582|NCT00420303|Other|Placebo|placebo
16330583|NCT00420290|Drug|kineret|100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
16330584|NCT00420290|Drug|placebo|100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
16330585|NCT00420277|Drug|Hemospan (MP4OX)|250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
16330586|NCT00420277|Drug|Voluven (HES 130/0.4)|250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
16330587|NCT00420264|Device|Uterine Ablation|Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation
16330588|NCT00420251|Drug|Genotropin|
16330589|NCT00420238|Drug|Etanercept (Enbrel)|50 mg injection once weekly
16330590|NCT00420238|Other|Placebo|placebo
16330591|NCT00420225|Device|Low-weight prolypropylene mesh|
16330592|NCT00420212|Drug|BG00012|
16330593|NCT00420212|Drug|Placebo|
16330594|NCT00420199|Drug|Abatacept|Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
16330595|NCT00420199|Drug|Placebo|Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment
16330596|NCT00420186|Drug|BMS-690514|Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos
16330597|NCT00420173|Procedure|Laboratory analysis|blood withdrawal
16330598|NCT00420160|Behavioral|Smoking cessation treatment plus moderate intensity exercise|
16330599|NCT00420160|Behavioral|Smoking cessation treatment plus health education|
16330600|NCT00420147|Device|wedged inshoe orthosis|Treatment subjects were prescribed an inshoe wedged orthosis
16330601|NCT00420147|Device|neutral inshoe orthosis|Control subjects were prescribed a neutral inshoe orthosis
16330602|NCT00420134|Procedure|injection of progenitor of hepatocyte drived from Mesenchymal stem cell|
16330603|NCT00420121|Procedure|laboratory analysis|blood withdrawal for laboratory analysis
16330604|NCT00420095|Drug|Human insulin 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
16330605|NCT00420095|Drug|Insulin lispro low mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
16330606|NCT00420082|Drug|Bilastine|Encapsulated Bilastine 20 mg tablets Q.D.
16330607|NCT00420082|Drug|Fexofenadine|Encapsulated Fexofenadine 120 mg tablets Q.D.
16330608|NCT00420082|Drug|Cetirizine|Encapsulated Cetirizine 10 mg tablets Q.D.
16330609|NCT00420082|Drug|Placebo|Encapsulated Placebo tablets Q.D.
16330610|NCT00420069|Device|MRTX device|device for ventilation
16330611|NCT00420056|Drug|PD-0332991|125 mg, oral, Days 1-21 of a 28-day cycle
16330612|NCT00420043|Drug|imatinib|
16330613|NCT00420030|Drug|Abciximab|Abciximab - IIb/IIIa GP inhibitor, dosage - bolus + continuous infusion
16330614|NCT00420017|Drug|Amiodarone|Intravenous amiodarone continuous infusion x 4 days
16330615|NCT00420017|Other|Control|No amiodarone
16330616|NCT00420004|Drug|LY2216684|3-mg and 6-mg tablets
16330617|NCT00420004|Drug|Placebo|
16330618|NCT00420004|Drug|Escitalopram|10-mg capsules
16330619|NCT00419991|Drug|Tigecycline|All patients will receive tigecycline infusions approximately every 12 or 24 hours. The usual regimen of tigecycline is (an initial intravenous (IV) dose of 100 mg followed by 50 mg approximately every 12 hours). Patients with severe hepatic dysfunction may, at the investigator's discretion with CPL Associates approval (call enrollment hotline) may be given a total daily dose of 50 mg (one 50 mg dose or 25 mg approximately every 12 hours). Tigecycline infusions will be administered over approximately 30 minutes in 100 mL of normal saline.
16330620|NCT00419978|Procedure|Colectomy|
16330621|NCT00419952|Drug|Budesonide/formoterol (SYMBICORT) pMDI|Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
16330622|NCT00419952|Drug|Budesonide HFA pMDI|Budesonide HFA pMDI 160 ug x 2 actuations BID
16330623|NCT00419926|Drug|Enteric-coated mycophenolate sodium (Myfortic)|1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
16330792|NCT00418535|Drug|Concurrent Radiotherapy (RT)/cisplatin, VIPD|
16330624|NCT00419926|Drug|Cyclosporine (Neoral)|cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels
16330625|NCT00419926|Drug|Prednisone|20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.
16330626|NCT00419913|Dietary Supplement|Dehydroepiandrosterone|DHEA 25 mg tid
16330627|NCT00419900|Procedure|diagnosis of breast cancer by x-ray diffraction of hair|
16330628|NCT00419887|Drug|Vildagliptin (LAF237)|
16330629|NCT00419848|Drug|Doxycycline|Cap 100mg- 100mg/daily
16330630|NCT00419848|Drug|Azithromycin|Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
16330631|NCT00419835|Drug|enalapril|
16330632|NCT00419835|Drug|losartan|
16330633|NCT00419822|Procedure|Acupuncture|6 Acupuncture visits
16330634|NCT00419822|Procedure|Sham Acupuncture|6 Acupuncture visits with sham procedure
16330635|NCT00419822|Other|Patient to receive standard care without Acupuncture or Sham Acupuncture.|Standard care
16330636|NCT00419809|Drug|SB-681323 oral tablets|
16330637|NCT00419796|Drug|Lumiracoxib|
16330638|NCT00419783|Drug|bilastine|20 mg tablets.
16330639|NCT00419783|Drug|Bilastine|100 mg (5 tablets of 20 mg)
16330640|NCT00419783|Drug|Bilastine & Ketoconazole|1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
16330641|NCT00419783|Drug|Moxifloxacin|1 capsule containing moxifloxacin 400 mg tablet
16330642|NCT00419783|Drug|Placebo|Placebo tablets
16330643|NCT00419770|Drug|deferasirox|20 mg/kg enterally per day
16330644|NCT00419770|Drug|Placebo|
16330645|NCT00419770|Drug|Liposomal amphotericin B|
16330646|NCT00419757|Drug|Budesonide/formoterol (SYMBICORT) pMDI|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
16330647|NCT00419757|Drug|Budesonide HFA pMDI|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
16330648|NCT00419744|Drug|Budesonide/formoterol (SYMBICORT) pMDI|
16330649|NCT00419744|Drug|Formoterol Turbuhaler|
16330650|NCT00419731|Drug|Bupropion|"Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
~Placebo, 25 mg, q.d., for 7 weeks."
16330651|NCT00419731|Drug|Bupropion + Naltrexone|"Bupropion, Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
~Naltrexone, 25 mg, q.d., for 7 weeks."
16330652|NCT00419718|Drug|inhaled human insulin|
16330653|NCT00419705|Device|NeuroThera® Laser System|Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
16330654|NCT00419692|Drug|Ropinirole|Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.
16330655|NCT00419679|Procedure|x-ray diffraction of human hair|
16330656|NCT00419666|Drug|Calcitriol 3mcg/g|Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
16330657|NCT00419653|Drug|Amisulpride|
16330658|NCT00419653|Drug|Olanzapine|
16330659|NCT00419653|Drug|Haloperidol|
16330660|NCT00419640|Device|Pacemaker implantation with RA lead in LAS position|Pacemaker implantation with RA lead placed in low atrial septal position
16330661|NCT00419640|Device|Pacemaker implantation with RA lead in LAS position|Pacemaker implantation with RA lead placed in low atrial septal position
16330662|NCT00419640|Device|Pacemaker implantation with RA lead in RAA position|Pacemaker implantation with RA lead placed in right atrial appendage position
16330663|NCT00419640|Device|Pacemaker implantation with RA lead in RAA position|Pacemaker implantation with RA lead placed in right atrial appendage position
16330664|NCT00419601|Drug|Remifentanyl|Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h
16330665|NCT00419601|Drug|Fentanyl|start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h
16330666|NCT00419562|Drug|Oral Insulin|7.5 mg oral insulin or placebo given before breakfast on a daily basis.
16330667|NCT00419562|Drug|Placebo|Placebo capsule designed to match active drug
16330668|NCT00419549|Drug|Glyceryl - trinitrate|Transdermal Patch once only
16330669|NCT00419549|Drug|Valdecoxib|Single parenteral administration
16330670|NCT00419536|Drug|LBH589|
16330671|NCT00419510|Behavioral|Culturally Tailored Genetic Counseling|
16330672|NCT00419497|Behavioral|Paleolithic diet vs Mediterranean diet|Prudent diets with or without grains and dairy
16330673|NCT00419484|Drug|pioglitazone|
16330674|NCT00419471|Drug|Escitalopram|Study medication will be provided as 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day, and matched placebo. The initial dose of escitalopram was 10mg/day generally, but 5mg/day for those aged 65 or over and with hepatic dysfunction. After the 2nd evaluation, the treatment doses are determined by the investigators' clinical decision considering the severity of depression and tolerability of drug. Drugs are taken once daily per orally within 30 min after the supper meal.
16330675|NCT00419471|Drug|Placebo|Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
16330676|NCT00419458|Procedure|inspiratory muscle strength training|
16330677|NCT00419445|Drug|GTS21/Placebo|
16330678|NCT00419432|Other|Routine Observational Analysis (prior to procedure)|Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.
16330679|NCT00419432|Other|Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)|This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data
16330680|NCT00419419|Drug|Topical AmphiMatrix with nitroglycerin (MQX-503)|
16330681|NCT00419406|Procedure|UVA1 phototherapy|
16330682|NCT00419406|Procedure|NB-UVB phototherapy|
16330683|NCT00419393|Drug|Keppra XR (Levetiracetam XR)|500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
16330684|NCT00419380|Drug|dornase alfa (Pulmozyme®)|This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
16330685|NCT00419367|Drug|Comparator: vorinostat|Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.
16330686|NCT00419341|Biological|Human Normal Immunoglobulin for Subcutaneous Administration|
16330687|NCT00419328|Drug|NGR-hTNF|iv q3W escalating dose up 1.6 mcg/sqm
16330688|NCT00419315|Behavioral|Alcohol Care Management|Care management for alcohol dependence with a focus on pharmacotherapy
16330689|NCT00419315|Behavioral|Usual Care|Usual care included a referral to a specialty addiction treatment program.
16330690|NCT00419302|Drug|Technosphere/Insulin|
16330691|NCT00419289|Behavioral|follow-up rehabilitation of participants with COPD|
16330692|NCT00419276|Procedure|Ambulatory continuous femoral nerve block for 100 hours|Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.
16330693|NCT00419263|Drug|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
16330694|NCT00419263|Drug|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
16330695|NCT00419263|Drug|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
16330696|NCT00419250|Drug|lenalidomide|
16330697|NCT00419250|Drug|lenalidomide|
16330698|NCT00419250|Drug|lenalidomide|
16330699|NCT00419250|Drug|lenalidomide|
16330700|NCT00419250|Drug|lenalidomide|
16330701|NCT00419237|Drug|GW685698X|GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.
16330702|NCT00419224|Biological|inactivated split-virus influenza vaccine|
16330703|NCT00419211|Behavioral|Exercise|Tailored exercise program
16330704|NCT00419198|Procedure|Postconditioning|Postconditioning during angioplasty
16330705|NCT00419198|Procedure|standard angioplasty|standard angioplasty without postconditioning
16330706|NCT00419185|Procedure|Delamination of the Internal limiting membrane|
16330707|NCT00419172|Drug|Deferasirox|
16330708|NCT00419172|Drug|Rifampicin|
16330709|NCT00419159|Drug|Everolimus (RAD001)|Everolimus was supplied in 5 mg tablets in blister packs.
16330710|NCT00419146|Drug|Ethyl-eicosapentaenoic acid (EPA)|Capsules, 2 g per day for 16 weeks
16330711|NCT00419146|Drug|Vitamins E + C|RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks
16330712|NCT00419146|Other|Etyl EPA (placebo)|Paraffin oil. Capsules, each 0.5 g.
16330713|NCT00419146|Other|Vitamins E+C (placebo)|Tablets containing dicalciumphosphate
16330714|NCT00419133|Biological|Killed bivalent whole cell oral cholera vaccine|"Each 1.5 mL dose, given orally, contains:
~V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS"
16330715|NCT00419133|Biological|Heat Killed E. coli Placebo|Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
16330716|NCT00419120|Biological|Autologous neo bladder construct|augmentation cystoplasty with autologous neo-bladder construct
16330717|NCT00419094|Drug|Keppra XR|Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
16330718|NCT00419094|Drug|Keppra XR|Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
16330719|NCT00419081|Drug|Forodesine Hydrochloride Sterile Solution, 5 mg/mL|
16330720|NCT00419081|Drug|Forodesine Hydrochloride Capsules (100 mg)|
16330721|NCT00419068|Drug|Cholecalciferol|
16330722|NCT00419068|Drug|Migliol Placebo Oil|
16330723|NCT00419055|Procedure|Early discharge after percutaneous coronary intervenntion|Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.
16330724|NCT00419042|Drug|TARCEVA|Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
16330725|NCT00419042|Drug|Gemzar|GEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes
16330726|NCT00419029|Behavioral|telephone-administered motivational interviewing|telephone motivational interviewing
16330727|NCT00419029|Behavioral|control|brief telephone check-in (no motivational interviewing)
16330728|NCT00419003|Drug|Lamotrigine|anticonvulsant medication
16330729|NCT00419003|Drug|Ketamine|subanesthetic dose of NMDAR antagonist
16330730|NCT00419003|Drug|Riluzole|glutamate release inhibitor
16330731|NCT00418990|Drug|Multivitamin/Mineral supplements|
16330732|NCT00418977|Behavioral|"Family-Based Therapy (Maudsley Method)"|The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction.
16330793|NCT00418522|Drug|Insulin glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
16330794|NCT00418522|Drug|Inhaled Insulin (Exubera)|Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
16330795|NCT00418509|Drug|Mometasone furoate|
16330796|NCT00418509|Drug|Formoterol fumarate|
16330733|NCT00418977|Behavioral|Individual Supportive Psychotherapy|The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment.
16330734|NCT00418964|Procedure|Single bundle hamstring|Single bundle hamstring
16330735|NCT00418964|Procedure|Double bundle hamstring|Double bundle hamstring
16330736|NCT00418964|Procedure|Bone patellar tendon bone|Bone patellar tendon bone
16330737|NCT00418951|Drug|Voriconazole|400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily
16330738|NCT00418951|Drug|Liposomal amphotericin B|3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes
16330739|NCT00418951|Drug|Liposomal amphotericin B|9 mg/kg intravenously once per week over 2 hours +/- 15 minutes
16330740|NCT00418938|Drug|Panitumumab|6mg/kg IV
16330741|NCT00418938|Drug|Bevacizumab|Either 5mg/kg OR 10mg/kg IV
16330742|NCT00418938|Drug|Leucovorin|400mg/m^2 IV (in the vein)
16330743|NCT00418938|Drug|Irinotecan|180mg/m^2 IV (in the vein)
16330744|NCT00418938|Drug|5-Fluorouracil|400mg/m^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m^2 thereafter if no significant side effects
16330745|NCT00418925|Drug|Dronabinol|2.5 mg tablets; titrated over 14 days and 7 days steady dose
16330746|NCT00418899|Behavioral|Questionnaire|Questionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information).
16330747|NCT00418886|Drug|Vandetanib|oral once daily tablet
16330748|NCT00418886|Drug|Pemetrexed|intravenous infusion
16330749|NCT00418873|Drug|Zotepine|Oral
16330750|NCT00418873|Drug|Risperidone|Oral
16330751|NCT00418860|Drug|Aspirin, Clopidogrel|Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
16330752|NCT00418847|Drug|miglustat|Target dose of 320 mg/m^2/day (divided in 3 doses) will be based on the Body Surface Area (BSA). For children with a BSA > 1.3, 200 mg TID will be administered. For children with a BSA of 0.8-1.3, 100 mg TID will be administered.
16330753|NCT00418834|Drug|ezetimibe and atorvastatin|ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
16330754|NCT00418834|Drug|atorvastatin|Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
16330755|NCT00418834|Drug|Placebo (unspecified)|Placebo (unspecified) daily for 12 weeks
16330756|NCT00418821|Biological|Aldurazyme (laronidase)|dose of 0.58mg/kg body weight intravenously (IV) every week
16330757|NCT00418795|Drug|recombinant human porphobilinogen deaminase (Porphozym)|
16330758|NCT00418782|Drug|naproxen|
16330759|NCT00418782|Drug|CE-224535|
16330760|NCT00418782|Drug|placebo|
16330761|NCT00418769|Drug|Nilotinib|
16330762|NCT00418756|Drug|Nilotinib|Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.
16330763|NCT00418730|Drug|tetrapeptide aldehyde proteasome inhibitor (NEOSH101)|Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
16330764|NCT00418717|Drug|etanercept|Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
16330765|NCT00418704|Drug|Erlotinib|Tarceva (150 mg) is a pill you take once a day -- every day
16330766|NCT00418704|Drug|taxotere|Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.
16330767|NCT00418691|Drug|IR Methylphenidate|10 mg by mouth (PO) twice daily x 4 Weeks
16330768|NCT00418691|Drug|Modafinil|200 mg PO Once Daily x 4 Weeks
16330769|NCT00418691|Drug|SR Methylphenidate|18 mg PO Once Daily x 4 Weeks
16330770|NCT00418678|Drug|Cesamet|2 mg BID on Days 2-5.
16330771|NCT00418665|Biological|AMG 531|AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
16330772|NCT00418665|Drug|Placebo|Subjects in the control group will receive placebo via subcutaneous injection.
16330773|NCT00418652|Device|No TMS intervention|"In the no TMS condition, no simulation was given and no coil placed near participants' heads."
16330774|NCT00418652|Device|TMS over the PO3 EEG site|10Hz TMS over the dorsal stream (PO3 EEG site)
16330775|NCT00418652|Device|TMS over the vertex|10Hz TMS for over vertex.
16330776|NCT00418639|Drug|Nitazoxanide|
16330777|NCT00418626|Drug|Nilotinib|
16330778|NCT00418613|Drug|MK633|MK0633 100mg capsules qd for a 12-wk treatment period.
16330779|NCT00418613|Drug|Comparator: Placebo (unspecified)|MK0633 100mg Pbo capsules for a 12-wk treatment period
16330780|NCT00418600|Drug|Hectorol® (doxercalciferol capsules)|Hectorol capsules at 1.0 times current injection dose
16330781|NCT00418600|Drug|doxercalciferol capsules, Hectorol®|Hectorol capsules at 1.5 times current injection dose
16330782|NCT00418600|Drug|doxercalciferol capsules, Hectorol® capsules|Hectorol capsules at 2.0 times current injection dose
16330783|NCT00418587|Drug|Cholecalciferol|800 IU oral daily
16330784|NCT00418587|Drug|Cholecalciferol|2000 IU oral daily
16330785|NCT00418587|Drug|Cholecalciferol|4000 IU oral daily
16330786|NCT00418574|Biological|Abagovomab|2 mg/ml SC (subcutaneously)
16330787|NCT00418574|Biological|Placebo|2 mg/ml SC (subcutaneously)
16330788|NCT00418561|Biological|rhASA - Dose Level 1|Intravenous infusion 25 U/kg as a single dose - hereafter 50 U/kg every other week for 26 weeks
16330789|NCT00418561|Biological|rhASA - Dose Level 2|Intravenous infusion 100 U/kg every other week for 26 weeks
16330790|NCT00418561|Biological|rhASA - Dose Level 3|Intravenous infusion 200 U/kg every other week for 26 weeks
16330791|NCT00418548|Drug|Etanercept|
16330797|NCT00418496|Drug|Aldesleukin|600,000 IU/kg every 8 hours on days 1-5 (week 1) to a maximum of 12 doses. Another cycle of HD aldesleukin will be started on day 15 (week 3).
16330798|NCT00418496|Drug|Sorafenib|To be initiated at a dose of 200 mg orally. Once it is determined that no further HD aldesleukin therapy will be given, sorafenib may be given daily at the FDA approved dose of 400 mg twice daily until there is lack of clinical benefit or intolerable side effects develop.
16330799|NCT00418483|Biological|Plasmin (Human) 25 mg|Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330800|NCT00418483|Biological|Plasmin (Human) 50 mg|Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330801|NCT00418483|Biological|Plasmin (Human) 75 mg|Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330802|NCT00418483|Biological|Plasmin (Human) 100 mg|Plasmin (Human) 100 mg
16330803|NCT00418483|Biological|Plasmin (Human) 125 mg|Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330804|NCT00418483|Biological|Plasmin (Human) 150 mg|Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330805|NCT00418483|Biological|Plasmin (Human) 175 mg|Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
16330806|NCT00418470|Procedure|regular dilution of antibiotic in NS|IV administration of ceftazidime tid diluted in regular NS volume
16330807|NCT00418470|Procedure|higher dilution of antibiotic in NS|IV administration of ceftazidime tid diluted in larger NS volume
16330808|NCT00418457|Drug|General anesthesia and opioids|General anesthesia, usually with sevoflurane, and opioid analgesia
16330809|NCT00418457|Drug|Regional analgesia and propofol|Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
16330810|NCT00418444|Behavioral|Group Therapy Intervention|
16330811|NCT00418431|Drug|Intravitreal injection of Bevacizumab|
16330812|NCT00418418|Procedure|Coronary bypass operation|Coronary bypass operation is performed via sternotomy during cardiac arrest.
16330813|NCT00418418|Procedure|Bone marrow aspiration (crista iliaca)|The bone marrow is aspirated from the iliac crest (100ml). During the operation the aspirate is transported to the stem cell laboratory, where the sample is centrifugated through Ficoll(Registered Trademark).
16330814|NCT00418418|Biological|Intramyocardial mesenchymal stem cell transplantation|During the cardiac arrest, stem cells are directly injected to myocardium. The amount of the cells varies individually (5-1000 x 10e6 cells), the cells are diluted in autologous serum (5 ml)
16330815|NCT00418418|Biological|Intramyocardial injection of autologous serum|Intramyocardial injection of autologous serum is injected during cardiac arrest
16330816|NCT00418392|Procedure|Simple aspiration with minocycline pleurodesis|Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration
16330817|NCT00418392|Procedure|simple aspiration|Simple aspiration for primary spontaneous pneumothorax by pigtail catheter
16330818|NCT00418379|Drug|300 IR (4M)|300 IR grass pollen allergen extract tablet starting 4 months before the pollen season
16330819|NCT00418379|Drug|300 IR (2M)|300 IR grass pollen allergen extract tablet starting 2 months before the pollen season
16330820|NCT00418379|Drug|Placebo|Placebo tablet
16330821|NCT00418366|Drug|MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days|
16330822|NCT00418353|Drug|Betamethasone(Celestone soluspan) and Dexamethasone|
16330823|NCT00418340|Drug|probiotic (bacterial/dietary supplement)|
16330824|NCT00418327|Drug|Tarceva (Erlotinib Hydrochloride)|tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily
16330825|NCT00418314|Device|Control|Empiric programming or one-time optimization using a non-IEGM method.
16330826|NCT00418314|Device|QuickOpt|Frequent optimization using QuickOpt to optimize AV/PV and VV delays.
16330827|NCT00418301|Other|Precision Spinal Cord Stimulation and PET Scan|Imaging procedure to assess spinal Cord Stimulation.
16330828|NCT00418288|Drug|glucagon-like-peptide-1|intravenous infusion of 1.2pmol/kg/min for 7 hours
16330829|NCT00418288|Drug|placebo|intravenous infusion of 1.2pmol/kg/min
16330830|NCT00418275|Genetic|Recombinant Human Plasminogen Activator (HTUPA)|
16330831|NCT00418262|Drug|Atomoxetine|Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.
16330832|NCT00418249|Drug|AS101|
16330833|NCT00418210|Radiation|Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)|Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days
16330834|NCT00418197|Device|Total Facet Arthroplasty System® (TFAS®)|
16330835|NCT00418184|Dietary Supplement|Phosphatidylserine-Omega3|Phosphatidylserine-Omega3 conjugate capsules. Weeks 0-15: 300 mg/day. weeks 16-30: 150 mg/day and a 150 mg/day one year follow-up.
16330836|NCT00418184|Other|Colored cellulose tainted with fishy odor|as arm 1
16330837|NCT00418171|Drug|Ziprasidone|
16330838|NCT00418171|Drug|Olanzapine|
16330839|NCT00418158|Behavioral|use of Airlife (therapy)|
16330840|NCT00418145|Drug|megadose oral methylprednisolone|1400 mg qd/5 days
16330841|NCT00418145|Drug|IV methylprednisolone|1000 mg/qd/5 days
16330842|NCT00418132|Drug|Thalidomide|Thalidomide at a dose of 50 mg/day. The dose will be increased to 100 mg/day at Week 2, then to 200 mg/day at Week 4, and finally to 300 mg/day at Week 6.
16330843|NCT00418132|Drug|Placebo thalidomide|Participants will receive placebo thalidomide. The placebo dose will be increased through to Week 6.
16330844|NCT00418119|Drug|erythropoietin|
16330845|NCT00418093|Drug|Gemcitabine|Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
16330846|NCT00418093|Drug|Oxaliplatin|Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
16330847|NCT00418093|Drug|Bevacizumab|Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
16330848|NCT00418080|Drug|bicalutamide|
16330855|NCT00418015|Procedure|Blood Draw|Blood for OPRM1 analysis
16330856|NCT00418002|Drug|AQW051|
16330857|NCT00417989|Device|MiniMed Paradigm REAL-Time System|Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter
16330858|NCT00417976|Drug|Gemcitabine|1000 mg/m2 over 100 minutes every 2 weeks.
16330859|NCT00417976|Drug|Bevacizumab|10 mg/kg every 2 weeks.
16330860|NCT00417976|Drug|Infusional 5-Fluorouracil|2400 mg/m2 over 48 hours every 2 weeks.
16330861|NCT00417963|Device|Carotid Artery Stenting|placement of a bare metal stent at sites of stenosis in the carotid artery
16330862|NCT00417950|Drug|Acarbose|
16330863|NCT00417937|Drug|azelaic acid 15% gel|15% gel, topically applied once daily for six weeks
16330864|NCT00417937|Drug|azelaic acid 15% gel|15% gel, topically applied twice daily for six weeks
16330865|NCT00417924|Behavioral|Patient education|
16330866|NCT00417911|Drug|bortezomib|Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles
16330867|NCT00417898|Drug|Aspirin|
16330868|NCT00417885|Drug|exemestane|25 mg, oral, daily dosing
16330869|NCT00417885|Drug|sunitinib malate|37.5 mg, oral, continuous dosing, daily
16330870|NCT00417872|Drug|Nitazoxanide|
16330871|NCT00417872|Drug|Metronidazole|
16330872|NCT00417859|Device|Total knee arthroplasty: mobile bearing|Total knee arthroplasty: mobile bearing
16330873|NCT00417833|Drug|Intravitreal Bevacizumab|
16330874|NCT00417820|Drug|BCT194|
16330875|NCT00417807|Drug|Imatinib mesilate|
16330876|NCT00417794|Drug|Strattera|escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy
16330877|NCT00417794|Drug|Placebo|0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.
16330878|NCT00417768|Drug|Tissue Plasminogen Activator|The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.
16330879|NCT00417768|Other|Normal Saline|Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
16330880|NCT00417742|Behavioral|Service delivery through a Headache Management Program|
16330881|NCT00417729|Drug|Acarbose|After an 8-week period of metformin monotherapy (500 mg t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., respectively, for the last 12 weeks.
16330882|NCT00417716|Drug|Intravitreal Bevacizumab|
16330883|NCT00417690|Drug|4-Aminosalicylic acid|Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
16330884|NCT00417690|Drug|PASER placebo granules|Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks
16330885|NCT00417677|Drug|Combination of Temsirolimus and Sunitinib|
16330886|NCT00417664|Drug|dexmedetomidine|
16330887|NCT00417664|Drug|midazolam|
16330888|NCT00417664|Drug|propofol|
16330889|NCT00417638|Device|Endovascular cooling by the Celsius Control System|
16330890|NCT00417638|Other|Standard of care|
16330891|NCT00417612|Drug|Paricalcitol|Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits.
16330892|NCT00417612|Other|Placebo|Placebo sugar pill
16330893|NCT00417599|Behavioral|Lifestyle Intervention|lifestyle intervention .
16330894|NCT00417599|Other|control group|waiting list control group
16330895|NCT00417586|Device|Specialized Doppler Ultrasound Instrument|Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening
16330896|NCT00417573|Drug|IV Gamunex 10%|
16330897|NCT00417560|Biological|inactivated influenza A/H5N1 vaccine|
16330898|NCT00417521|Behavioral|Family-Based Treatment|
16330899|NCT00417508|Dietary Supplement|Sip feeding|Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
16330900|NCT00417508|Dietary Supplement|Dietary Advice|The patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements.
16330901|NCT00417495|Behavioral|Sentinel Lymph Node Technique|
16330902|NCT00417482|Drug|risperidone|Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial
16330903|NCT00417469|Device|NADGL|
16330904|NCT00417456|Other|Evisit|Asynchronous,remote care delivery via a secure web platform
16330905|NCT00417456|Other|Office visit|Conventional office-based care
16330906|NCT00417443|Drug|Clonidine|
16330907|NCT00417430|Drug|ICI 182,780 (Faslodex)|
16330908|NCT00417417|Drug|Rilonacept|Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine, arginine, and sucrose (pH 6.5). Matching placebo in the identical formulation will also be supplied, and also reconstituted with 2.3 mL of sterile water for injection. Each administration of study drug will consist of two syringes containing 2.0 mL in each syringe (320 mg total drug).
16330909|NCT00417417|Drug|Placebo|Normal saline subcutaneously at each treatment visit.
16330910|NCT00417404|Drug|Aquasol A|IM Aquasol A 10,000IU three times weekly
16330911|NCT00417404|Drug|aquasol A|10,000 IU three times weeks, by intramuscular injection
16330912|NCT00417404|Other|sham injection|sham injection
16330913|NCT00417391|Drug|RR110 (Tamibarotene)|1 mg RR110
16330914|NCT00417391|Drug|RR110 (Tamibarotene)|4 mg RR110
16330915|NCT00417378|Device|Left Ventricular Assist Device Impella LP 2.5|Left Ventricular Assist Device
16330916|NCT00417378|Device|Intraaortic Balloon Pump|Counterpulsation
16330917|NCT00417365|Device|WaterWorks Douching Device|
16330918|NCT00417352|Device|Brace|
16330919|NCT00417352|Device|Added mass|
16330920|NCT00417339|Procedure|hemodialysis|individualised
16330921|NCT00417326|Drug|ONO-5046Na|twenty four hour infusion at 0 mg/kg/hr for 14 days
16330922|NCT00417326|Drug|ONO-5046Na|twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days
16330923|NCT00417313|Device|periosteal electro-acupuncture (osteopuncture).|
16330924|NCT00417287|Drug|PX-12|3 hour intravenous infusion as a dose of either 54 mg/m2 or 128 mg/m2 daily for 5 days every three weeks.
16330925|NCT00417274|Drug|Quinacrine|100 mg daily
16330926|NCT00417261|Drug|ATF936|
16330927|NCT00417261|Drug|AXT914|
16330928|NCT00417248|Drug|Cisplatin|Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
16330929|NCT00417248|Drug|Etoposide|Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
16330930|NCT00417248|Procedure|Radiotherapy|Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
16330931|NCT00417248|Drug|Sorafenib|Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
16330932|NCT00417235|Device|Chlorhexidine Sponge (Biopatch TM)|dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
16330933|NCT00417235|Behavioral|7-day catheter dressing frequency|dressing changes every 7 days versus every classical change every 3 days
16330934|NCT00417222|Drug|olmesartan medoxomil|5 to 40mg P.O. daily until the end of the study
16330935|NCT00417209|Drug|Larotaxel (XRP9881)|administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
16330936|NCT00417209|Drug|5-Fluorouracil|administered as IV infusion from Day 1 to Day 4
16330937|NCT00417209|Drug|Capecitabine|administered orally from Day 1 to Day 14 q3w
16330938|NCT00417196|Drug|QAX576|
16330939|NCT00417183|Drug|Arvekap 0.1 mg (Triptorelin, Ipsen, France)|
16330940|NCT00417183|Drug|Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)|
16330941|NCT00417170|Drug|Aliskiren|Aliskiren 300 mg tablets taken orally once daily
16330942|NCT00417170|Drug|Amlodipine|Amlodipine 5 mg capsule taken orally once daily
16330943|NCT00417170|Drug|Placebo Aliskiren|Placebo Aliskiren taken orally once daily.
16330944|NCT00417170|Drug|Placebo Amlodipine|Placebo Amlodipine taken orally once daily
16330945|NCT00417157|Drug|recombinant FSH (Puregon, Organon, The Netherlands)|
16330946|NCT00417157|Drug|GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)|
16330947|NCT00417157|Drug|hCG (Pregnyl, Organon, The Netherlands)|
16330948|NCT00417144|Drug|Arvekap 0.1mg (Triptorelin, Ipsen, France)|
16330949|NCT00417144|Drug|Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)|
16330950|NCT00417118|Drug|Saredutant|oral administration (capsules)
16330951|NCT00417118|Drug|Escitalopram|oral administration (capsules)
16330952|NCT00417118|Drug|Placebo|oral administration (capsules)
16330953|NCT00417105|Procedure|hemodialysis|group 1: twice weekly, four hours
16330954|NCT00417105|Procedure|hemodialysis|group 2: twice weekly, eight hours
16330955|NCT00417105|Procedure|hemodialysis|group 3: every other day, eight hours
16330956|NCT00417105|Procedure|hemodialysis|group 4: six days a week, eight hours
16330957|NCT00417092|Procedure|Postoperative Pacing|
16330958|NCT00417079|Drug|cabazitaxel (XRP6258) (RPR116258)|25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
16330959|NCT00417079|Drug|mitoxantrone|12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
16330960|NCT00417079|Drug|prednisone|10 mg daily administered by oral route
16330961|NCT00417066|Drug|Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)|
16330962|NCT00417066|Drug|Arvekap 0.1mg (Triptorelin, Ipsen, France)|
16330963|NCT00417053|Biological|filgrastim|
16330964|NCT00417053|Drug|busulfan|
16330965|NCT00417053|Drug|carboplatin|
16330966|NCT00417053|Drug|cyclophosphamide|
16330967|NCT00417053|Drug|doxorubicin hydrochloride|
16330968|NCT00417053|Drug|etoposide phosphate|
16330969|NCT00417053|Drug|melphalan|
16330970|NCT00417053|Drug|vincristine sulfate|
16330971|NCT00417053|Procedure|autologous bone marrow transplantation|
16330972|NCT00417053|Procedure|bone marrow ablation with stem cell support|
16330973|NCT00417053|Procedure|conventional surgery|
16330974|NCT00417053|Procedure|peripheral blood stem cell transplantation|
16330975|NCT00417053|Radiation|radiation therapy|
16330976|NCT00417040|Other|internet-based intervention|Use the STAR database system
16330977|NCT00417040|Other|assessment of therapy complications|Use the STAR database system
16330978|NCT00417040|Other|Questionnaire Administration|Ancillary studies
16330979|NCT00417027|Procedure|Programmed Intermittent Epidural Bolus (PIEB)|A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes.
16330980|NCT00417014|Drug|chlorambucil|
16330981|NCT00417014|Drug|prednisolone|
16330982|NCT00417014|Drug|procarbazine hydrochloride|
16330983|NCT00417014|Drug|vinblastine sulfate|
16330984|NCT00417014|Radiation|radiation therapy|
16330985|NCT00417001|Procedure|Aroma therapy|
16330986|NCT00416988|Other|educational intervention|
16330987|NCT00416975|Other|counseling intervention|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
16330988|NCT00416975|Other|educational intervention|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
16330989|NCT00416975|Procedure|evaluation of cancer risk factors|Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
16330990|NCT00416962|Drug|amantadine hydrochloride|
16330991|NCT00416962|Drug|oseltamivir phosphate|
16330992|NCT00416949|Device|Patient-specific dosimetry|Patient-specific 3D-RD dosimetry was applied to the data collected
16330993|NCT00416923|Biological|rituximab|
16330994|NCT00416910|Biological|Filgrastim|
16330995|NCT00416910|Drug|Fludarabine|
16330996|NCT00416910|Drug|Cyclophosphamide|
16330997|NCT00416910|Drug|Mitoxantrone|
16330998|NCT00416897|Drug|chemotherapy|
16330999|NCT00416897|Drug|dexamethasone|
16331000|NCT00416897|Procedure|plasmapheresis|
16331001|NCT00416884|Drug|Campath|30 mg on day -8 over 5-6 hours
16331002|NCT00416884|Drug|Fludarabine|Fludarabine 30 mg/m^2 on day -4 through day -2
16331003|NCT00416884|Radiation|Total Body Irradiation (TBI)|Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0
16331004|NCT00416884|Other|T-Cell Deplete|Stem cells will be T cell depleted and given on day 0
16331005|NCT00416871|Biological|aldesleukin|
16331006|NCT00416871|Biological|recombinant interferon alfa|
16331007|NCT00416858|Drug|cisplatin|
16331008|NCT00416858|Drug|fluorouracil|
16331009|NCT00416858|Procedure|adjuvant therapy|
16331010|NCT00416858|Procedure|conventional surgery|
16331011|NCT00416858|Procedure|neoadjuvant therapy|
16331012|NCT00416858|Radiation|radiation therapy|
16331013|NCT00416845|Drug|FTY720|
16331014|NCT00416832|Drug|cyclophosphamide|
16331015|NCT00416832|Drug|dacarbazine|
16331016|NCT00416832|Drug|doxorubicin hydrochloride|
16331017|NCT00416832|Drug|etoposide|
16331018|NCT00416832|Drug|prednisone|
16331019|NCT00416832|Drug|procarbazine hydrochloride|
16331020|NCT00416832|Drug|vincristine sulfate|
16331021|NCT00416832|Radiation|radiation therapy|
16331022|NCT00416819|Biological|filgrastim|
16331023|NCT00416819|Biological|rituximab|
16331024|NCT00416819|Drug|cytarabine|
16331025|NCT00416819|Drug|etoposide phosphate|
16331026|NCT00416819|Drug|leucovorin calcium|
16331027|NCT00416819|Drug|methotrexate|
16331028|NCT00416819|Drug|temozolomide|
16331029|NCT00416793|Drug|bortezomib|Given IV
16331030|NCT00416793|Drug|carboplatin|Given IV
16331031|NCT00416793|Other|laboratory biomarker analysis|Correlative studies
16331032|NCT00416780|Other|counseling intervention|
16331033|NCT00416780|Other|educational intervention|
16331034|NCT00416780|Procedure|psychosocial assessment and care|
16331035|NCT00416767|Drug|fluorouracil|
16331036|NCT00416767|Drug|irinotecan hydrochloride|
16331037|NCT00416767|Drug|leucovorin calcium|
16331038|NCT00416754|Other|counseling intervention|subjects will receive genetic counseling
16331039|NCT00416741|Behavioral|Implementation of guidelines|Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose
16331040|NCT00416728|Drug|Aliskiren|
16331041|NCT00416728|Drug|Valsartan|
16331042|NCT00416715|Drug|letrozole|Given PO
16331043|NCT00416715|Dietary Supplement|calcium carbonate|Given PO
16331044|NCT00416715|Other|laboratory biomarker analysis|Optional correlative studies
16331045|NCT00416715|Dietary Supplement|calcium citrate|Given PO
16331046|NCT00416715|Dietary Supplement|calcium glucarate|Given PO
16331047|NCT00416715|Drug|calcium gluconate|Given PO
16331048|NCT00416715|Dietary Supplement|cholecalciferol|Given PO
16331049|NCT00416715|Procedure|assessment of therapy complications|Ancillary studies
16331050|NCT00416715|Procedure|musculoskeletal complications management/prevention|Correlative studies
16331051|NCT00416702|Drug|QAB149|
16331052|NCT00416689|Procedure|assessment of therapy complications|
16331053|NCT00416689|Procedure|quality-of-life assessment|
16331054|NCT00416676|Drug|carboplatin|
16331055|NCT00416676|Drug|cisplatin|
16331056|NCT00416676|Drug|cyclophosphamide|
16331057|NCT00416676|Drug|etoposide|
16331058|NCT00416676|Drug|vincristine sulfate|
16331059|NCT00416676|Procedure|adjuvant therapy|
16331060|NCT00416676|Procedure|conventional surgery|
16331061|NCT00416676|Procedure|neoadjuvant therapy|
16331062|NCT00416676|Radiation|radiation therapy|
16331063|NCT00416663|Procedure|Intracoronary administration of autologous ACPs|Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment
16331064|NCT00416650|Drug|erlotinib hydrochloride|All patients will receive 150 mg orally daily
16331065|NCT00416637|Biological|Bevacizumab (Avastin)|
16331066|NCT00416624|Drug|darbepoetin alfa|
16331067|NCT00416624|Drug|epoetin alfa|
16331068|NCT00416624|Procedure|fatigue assessment and management|
16331069|NCT00416624|Procedure|quality-of-life assessment|
16331070|NCT00416611|Behavioral|Implementation of guidelines|
16331071|NCT00416598|Procedure|Autologous Bone Marrow Transplantation|Undergo autologous bone marrow transplantation
16331072|NCT00416598|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC transplantation
16331073|NCT00416598|Drug|Busulfan|Given IV
16331074|NCT00416598|Drug|Cytarabine|Given IV
16331075|NCT00416598|Drug|Daunorubicin Hydrochloride|Given IV
16331076|NCT00416598|Drug|Decitabine|Given IV
16331077|NCT00416598|Drug|Etoposide|Given IV
16331078|NCT00416598|Biological|Filgrastim|Given SC
16331079|NCT00416598|Other|Laboratory Biomarker Analysis|Correlative studies
16331080|NCT00416598|Other|Pharmacological Study|Correlative studies
16331081|NCT00416585|Drug|isotretinoin (Roaccutane)|
16331082|NCT00416572|Behavioral|Education Intervention|Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.
16331083|NCT00416572|Behavioral|Nutrition Education Intervention|The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.
16331084|NCT00416559|Other|clinical observation|
16331085|NCT00416546|Drug|AEB071|
16331086|NCT00416533|Drug|docetaxel|
16331087|NCT00416533|Drug|doxorubicin hydrochloride|
16331088|NCT00416533|Drug|prednisone|
16331089|NCT00416520|Drug|MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)|3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
16331090|NCT00416520|Drug|Placebo|3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
16331091|NCT00416520|Drug|Another phosphate binder (Sevelamer)|Current approved dosing recommendations for 12 weeks
16331092|NCT00416507|Drug|fluorouracil|
16331093|NCT00416507|Drug|gemcitabine hydrochloride|
16331094|NCT00416507|Drug|liposomal cisplatin|
16331095|NCT00416494|Biological|bevacizumab|10 mg/kg intravenously over 30-90 minutes on day 1
16331096|NCT00416494|Drug|oxaliplatin|85 mg/m2 intravenously over 2 hours on day 1.
16331097|NCT00416494|Drug|Capecitabine|Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
16331098|NCT00416494|Drug|Capecitabine|Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
16331099|NCT00416481|Behavioral|quality of life questionnaires|
16331100|NCT00416468|Drug|Aliskiren|
16331101|NCT00416468|Drug|Valsartan|
16331102|NCT00416455|Radiation|fludeoxyglucose F 18|Undergo FDG PET/CT
16331103|NCT00416455|Procedure|positron emission tomography|Undergo FDG PET/CT
16331104|NCT00416455|Procedure|computed tomography|Undergo FDG PET/CT
16331105|NCT00416455|Drug|ferumoxtran-10|Undergo femoxtran-10 MRI
16331106|NCT00416455|Procedure|magnetic resonance imaging|Undergo femoxtran-10 MRI
16331107|NCT00416455|Procedure|diagnostic lymphadenectomy|Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
16331108|NCT00416455|Procedure|lymph node biopsy|Undergo pelvic and abdominal lymph node biopsy
16331109|NCT00416442|Drug|RSV604|
16331110|NCT00416429|Biological|aldesleukin|
16331111|NCT00416429|Biological|recombinant interferon alpha-2a|
16331112|NCT00416429|Drug|medroxyprogesterone|
16331113|NCT00416403|Drug|fluvastatin sodium|Given orally
16331114|NCT00416403|Procedure|Breast Cancer Surgery Only - Arm III|Breast Cancer Surgery
16331115|NCT00416390|Dietary Supplement|lycopene|
16331116|NCT00416390|Other|laboratory biomarker analysis|
16331117|NCT00416390|Procedure|biopsy|
16331118|NCT00416377|Biological|bleomycin sulfate|
16331119|NCT00416377|Drug|chlorambucil|
16331120|NCT00416377|Drug|dacarbazine|
16331121|NCT00416377|Drug|doxorubicin hydrochloride|
16331122|NCT00416377|Drug|prednisolone|
16331123|NCT00416377|Drug|procarbazine hydrochloride|
16331124|NCT00416377|Drug|vinblastine sulfate|
16331125|NCT00416377|Drug|vincristine sulfate|
16331126|NCT00416377|Radiation|radiation therapy|
16331127|NCT00416351|Drug|clofarabine|
16331128|NCT00416338|Device|film dressing by adhesive|
16331129|NCT00416325|Dietary Supplement|lycopene|
16331130|NCT00416325|Other|laboratory biomarker analysis|
16331131|NCT00416312|Device|Patient-specific dosimetry|"Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software.
~Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7."
16331168|NCT00415935|Drug|methotrexate|
16331169|NCT00415922|Drug|ELC200 (carbidopa+levodopa+entacapone)|
16331170|NCT00415909|Drug|Imatinib Mesylate (IM)|IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.
16331290|NCT00415090|Drug|Nevirapine|Switch one of ARV drugs to Nevirapine
16331132|NCT00416312|Device|conventional dosimetry|"Doses calculated using conventional dosimetry software.
~Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9."
16331133|NCT00416273|Drug|Bortezomib|Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.
16331134|NCT00416273|Drug|No intervention|Participants in the observation group will be observed and will not receive any consolidation therapy.
16331135|NCT00416260|Other|High Frequency Oscillation and Tracheal Gas Insufflation|Intermittent combined use of High Frequency Oscillation and Tracheal Gas Insufflation until the PaO2/inspired oxygen fraction ratio remains above than 150 mm Hg for more than 24 hours.
16331136|NCT00416247|Behavioral|Hypnosis|Hypnosis
16331137|NCT00416234|Procedure|Laparoendoscopic Rendez vous|intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
16331138|NCT00416234|Procedure|preoperative ERCP and CBD clearance|ERCP and CBD clearance followed by laparoscopic cholecystectomy
16331139|NCT00416221|Drug|Lexapro, an antidepressant medicine|
16331140|NCT00416221|Behavioral|Physical Activity|
16331141|NCT00416221|Behavioral|Mood Management Skills|
16331142|NCT00416221|Behavioral|Personalized support from a Family Nurse Practitioner|
16331143|NCT00416208|Drug|Bortezomib|1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
16331144|NCT00416195|Drug|E2007|
16331145|NCT00416195|Drug|Placebo|
16331146|NCT00416182|Drug|Pulmozyme (dornase alfa)|2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
16331147|NCT00416182|Drug|Placebo|2.5 mL of placebo delivered via Sinustar nebulizer device
16331148|NCT00416169|Drug|galantamine hydrobromide|
16331149|NCT00416156|Behavioral|Lifestyle modification|
16331150|NCT00416143|Procedure|bed rest|
16331151|NCT00416143|Drug|prednisone - oral corticosteroid 1mg/kg/D for 1 week|
16331152|NCT00416130|Drug|Vorinostat|MK-0683 capsules, 100 mg, 400mg once a day, continuously (at dose level 0 - Phase 1 part of the study)
16331153|NCT00416117|Procedure|Manual Physical Therapy and Exercise|
16331154|NCT00416117|Procedure|Minimal Intervention|
16331155|NCT00416078|Behavioral|caregiver website support|caregiver access to website support for 6 months embedded in one year of customary care
16331156|NCT00416078|Behavioral|caregiver brief supportive phone calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
16331157|NCT00416065|Device|PET/CT imaging|
16331158|NCT00416039|Drug|Midazolam|0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
16331159|NCT00416039|Drug|Placebo|placebo at 0.2 mg/kg and morphine 0.5 mg/kg
16331160|NCT00416026|Behavioral|Educational/Counseling/Training|
16331161|NCT00415987|Procedure|Hematopoietic Stem Cell Transplantation|
16331162|NCT00415974|Behavioral|Physician Counseling|Physician-patient visits will occur in the primary care setting and are scheduled at study onset (beginning of step 1) and at the end of the first year. An extra physician visit will occur for patients who do not progress from step 1 after two attempts. At study entry, physicians will discuss the purpose and importance of the intervention and encourage participation. Physicians will underline the value of attending all study visits and complying with study protocol and instructions. Subsequent physician visits will focus on weight loss progress and overcoming barriers.
16331163|NCT00415974|Behavioral|Health Educator|Health education sessions are held with teens and parents at the primary care setting. These include information on nutrition, physical activity, and weight loss. Behavioral approaches are used to enhance the home environment, food preparation, and planned physical activity to elicit weight loss, including discovery of perceived and actual barriers to modification of eating and physical activity behaviors. The Health Educator focuses on problem-solving and tailored selection of behavior change skills to help participants overcome difficulties. In addition to reviewing the assessment and generating solutions to barriers, sample meal plans (including strategies for restricting calories) and pedometers will be distributed at the initial health educator visit. Pedometers are encouraged to monitor progress with physical activity goals. An initial binder is distributed to teen and parent participants at the initial session and subsequent materials are added with each visit.
16331164|NCT00415974|Behavioral|Phone Counseling|Brief counseling calls will occur between PACE-PC participants and assigned counselors during all steps. In general, these calls occur on a bi-weekly to monthly basis in steps 1 and 2, and monthly in step 3. Such calls are intended to encourage continued goal attainment and progression and to promote healthy eating and physical activity behaviors. Counselors will review progress since the last clinical interaction (e.g., health educator visit, phone call, or physician visit) and help adolescents set new goals that are appropriate and attainable. Data from pedometers may be discussed during these sessions as an interim assessment of progress on physical activity behaviors between formal study measurement visits. After speaking with the adolescent, the counselor will talk with the parent (when feasible) to reinforce parental involvement and emphasize the importance of the healthy changes in the home environment to encourage goal attainment.
16331165|NCT00415974|Behavioral|Health promotion materials on physical activity and nutrition|PACE-PC adolescents and their families will receive information regarding healthy eating and physical activity behaviors on a weekly basis via mail. These behavioral-based materials will educate participants and their families on healthy behaviors that are necessary for successful weight management. Topics will coincide with the intervention goals and include supplemental information to enhance quality of life and improve body image. Topics will include realistic goal-setting and attainment, how to handle holidays and celebrations, eating fast food, grocery shopping and food preparation, and relapse prevention, etc.. Topics will include specific strategies related to the adolescent's readiness to change to reflect processes that are most appropriate. Content from these materials will be addressed by the phone counselors to ensure that participants received and understood intervention messages.
16331166|NCT00415961|Device|CoStar Paclitaxel Drug-Eluting Coronary Stent System|CoStar Paclitaxel Drug-Eluting Coronary Stent System
16331167|NCT00415948|Device|Biomarkers|
16331171|NCT00415909|Drug|TALL-104 cells|TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells
16331172|NCT00415896|Device|positive pressure ventilation|
16331173|NCT00415883|Drug|Valsartan|
16331174|NCT00415870|Behavioral|Printed Material|Printed Material
16331175|NCT00415870|Behavioral|Weekly Weighing|Weekly Weighing
16331176|NCT00415870|Behavioral|Cell phone will serve as a self monitoring device|Cell phone will serve as a self monitoring device
16331177|NCT00415870|Device|Text Message|Text Message
16331178|NCT00415870|Behavioral|Diet Goals via Cell Phone|Diet Goals via Cell Phone
16331179|NCT00415870|Behavioral|Food Monitoring|Food Monitoring
16331180|NCT00415857|Biological|Peptide Vaccine (PR1 Peptide)|PR1 peptide will be administered at a dose of 0.5 mg of PR1 on weeks 0, 3, 6 and 18 for a total of 4 doses.
16331181|NCT00415857|Drug|Peginterferon alfa-2b|Subcutaneous injection of interferon 0.5 microg/kg with each PR1 vaccination.
16331182|NCT00415857|Drug|Imatinib|Continue receiving imatinib by mouth at the same dose received during the last 6 months.
16331183|NCT00415857|Drug|GM-CSF|75 micrograms subcutaneously in the same area as the vaccine with every vaccination.
16331184|NCT00415844|Drug|ELC200 (carbidopa+levodopa+entacapone)|
16331185|NCT00415831|Drug|ELC200 (carbidopa+levodopa+entacapone)|
16331186|NCT00415818|Biological|MVA-MUC1-IL2|"MVA-MUC1-IL2:
~Dose of 10exp8 plaque forming units (pfu).
~Chemotherapy:
~Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first."
16331187|NCT00415818|Drug|1st line Chemotherapy|
16331188|NCT00415805|Drug|Multihance|0.5 Molar, single injection at 0.2 mL/kg
16331189|NCT00415805|Drug|vasovist|0.25 molar single injection 0.03 ml/kg
16331190|NCT00415792|Drug|Arvekap, Pregnyl|
16331191|NCT00415779|Drug|docetaxel|given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
16331192|NCT00415779|Drug|zoledronic acid|2 mg IV every 2 weeks
16331193|NCT00415766|Drug|rHCG 250ug|Injection of 250 ug Ovitrelle to trigger final oocyte maturation
16331194|NCT00415766|Drug|uHCG 5000 IU|Injection of 5000 IU Pregnyl to trigger final oocyte maturation
16331195|NCT00415766|Drug|uHCG 7500 IU|Injection of 7500 IU Pregnyl to trigger final oocyte maturation
16331196|NCT00415753|Behavioral|No antibiotics if se-procalcitonin is below stated limit|
16331197|NCT00415740|Drug|ELC200 (carbidopa+levodopa+entacapone)|
16331198|NCT00415727|Device|auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation|
16331199|NCT00415714|Device|Portable Biofeedback|
16331200|NCT00415701|Drug|Etomidate|Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
16331201|NCT00415701|Drug|Propofol|Single induction dose of propofol 2%; total dose 1.5 mg/kg
16331202|NCT00415701|Drug|Hydrocortisone|Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
16331203|NCT00415701|Drug|NaCl 0.9%|NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
16331204|NCT00415701|Other|Tetracosactin|Diagnostic test, Tetracosactin 250 microg iv
16331205|NCT00415688|Behavioral|Low carbohydrate, ketogenic diet|
16331206|NCT00415688|Behavioral|Low glycemic index, reduced calorie diet|
16331207|NCT00415675|Procedure|Motion CT Scans|A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.
16331208|NCT00415662|Device|Pulsed Signal Therapy (PST)|
16331209|NCT00415649|Biological|VRC-HIVDNA016-00-VP|
16331210|NCT00415649|Biological|VRC-HIVADV014-00-VP|
16331211|NCT00415649|Biological|Vaccine placebo|Placebo comparator
16331212|NCT00415636|Drug|IC83/LY2603618|40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.
16331213|NCT00415636|Drug|IC83/LY2603618|70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
16331214|NCT00415636|Drug|IC83/LY2603618|105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
16331215|NCT00415636|Drug|IC83/LY2603618|150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
16331216|NCT00415636|Drug|IC83/LY2603618|195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
16331217|NCT00415636|Drug|pemetrexed|pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
16331218|NCT00415636|Drug|pemetrexed|pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
16331219|NCT00415623|Drug|Amlodipine|Amlodipine 5mg/ day
16331220|NCT00415623|Drug|Amlodipine|Amlodipine 10mg/ day
16331221|NCT00415610|Drug|nicardipine|"Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
~Started at 5mg/h
~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
16331222|NCT00415597|Drug|ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)|capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
16331223|NCT00415584|Drug|Cinacalcet HCl|
16331224|NCT00415571|Drug|Fispemifene (once daily for 8 weeks)|
16331225|NCT00415558|Device|Microwave Ablation System|
16331226|NCT00415545|Behavioral|Fluid Watchers LITE Educational Intervention|Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.
16331288|NCT00415103|Drug|Palonosetron|Palonosetrón: 0.25 mg iv every 48 hours, starting day 1
16331289|NCT00415103|Drug|Granisetron|Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment
16331227|NCT00415545|Behavioral|Fluid Watchers PLUS Educational Intervention|Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.
16331228|NCT00415532|Drug|Medical Standard of Care for ITP|
16331229|NCT00415532|Biological|Romiplostim|
16331230|NCT00415519|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16331231|NCT00415519|Drug|Placebo of MCI-186|Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16331232|NCT00415506|Drug|Rituximab|Two 500 or 1000mg infusions over 2 weeks with the option of retreating after 6 months if initial improvement was seen.
16331233|NCT00415493|Other|Cold-dry air provocation|15 minute exposure to cold-dry air by nasal mask
16331234|NCT00415493|Other|Warm-moist air provocation|15 minute exposure to warm-moist air by nasal mask
16331235|NCT00415467|Device|GliaSite Radiation Therapy System|Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
16331236|NCT00415454|Genetic|Ad5-yCD/mutTKSR39rep-ADP|Single injection on day 1 at one of five dose levels
16331237|NCT00415441|Procedure|Physiotherapy program|
16331238|NCT00415441|Procedure|Placebo physiotherapy treatment|
16331239|NCT00415428|Behavioral|Patient adherence to national educational guidelines.|
16331240|NCT00415402|Drug|Vitamin D3|
16331241|NCT00415389|Behavioral|interactive educational program|2-session interactive stroke educational program
16331242|NCT00415389|Behavioral|usual medical care|standard educational materials and usual care
16331243|NCT00415376|Drug|levetiracetam|
16331244|NCT00415376|Procedure|quality-of-life assessment|
16331245|NCT00415363|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression
16331246|NCT00415363|Drug|placebo|oral, daily
16331247|NCT00415350|Drug|Azithromycin|Azithromycin Tablet 250 mg daily
16331248|NCT00415350|Other|Placebo|Placebo tablet 1 daily
16331249|NCT00415337|Procedure|endobronchial ultrasound|EBUS
16331250|NCT00415324|Drug|eribulin mesylate|Given IV
16331251|NCT00415324|Drug|cisplatin|Given IV
16331252|NCT00415324|Other|laboratory biomarker analysis|correlative study
16331253|NCT00415324|Other|pharmacological study|correlative study
16331254|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16331255|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16331256|NCT00415311|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16331257|NCT00415298|Drug|DACH polymer platinate AP5346|
16331258|NCT00415298|Drug|oxaliplatin|
16331259|NCT00415298|Genetic|gene expression analysis|
16331260|NCT00415298|Other|immunohistochemistry staining method|
16331261|NCT00415298|Other|pharmacological study|
16331262|NCT00415298|Procedure|biopsy|
16331263|NCT00415285|Drug|Docetaxel|
16331264|NCT00415285|Drug|Capecitabine|
16331265|NCT00415285|Drug|Docetaxel/Capecitabine|
16331266|NCT00415272|Behavioral|Pulmonary Rehabilitation|
16331267|NCT00415259|Device|Laterally wedged shoe insoles|Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
16331268|NCT00415259|Device|Control insole group|Flat control insoles worn inside the shoes daily for 12 months
16331269|NCT00415246|Drug|Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)|
16331270|NCT00415233|Biological|recombinant thyroid-stimulating hormone|Recombinant thyroid stimulating hormone (rhTSH) should be given at a dose of 0.9mg by intramuscular injection on two consecutive days before ablation.
16331271|NCT00415233|Radiation|Radiodine ablation without rhTSH|Patients in this group do not receive rhTSH pre ablation.
16331272|NCT00415220|Procedure|Spinal Manipulation, Microdiscectomy|
16331273|NCT00415194|Drug|pemetrexed|500 mg/m^2, IV, every 21 days, six 21 day cycles
16331274|NCT00415194|Drug|cisplatin|75 mg/m^2, administered IV, every 21 days, six 21 day cycles
16331275|NCT00415194|Drug|placebo|Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
16331276|NCT00415168|Drug|pemetrexed|700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles
16331277|NCT00415168|Drug|cisplatin|75 mg/m2, IV, every 21 days x 6 cycles
16331278|NCT00415155|Drug|LY2181308|"Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation)
~Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle."
16331279|NCT00415142|Drug|saredutant (SR48968)|oral administration (capsules)
16331280|NCT00415142|Drug|placebo|oral administration (capsules)
16331281|NCT00415142|Drug|escitalopram|oral administration (capsules)
16331282|NCT00415129|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5mL, Intramuscular
16331283|NCT00415129|Biological|A/H5N1 inactivated, split-virion influenza virus|0.5mL, Intramuscular
16331284|NCT00415116|Drug|carboplatin|
16331285|NCT00415116|Drug|docetaxel|
16331286|NCT00415116|Drug|lenalidomide|
16331287|NCT00415103|Drug|Aprepitant|Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days
16331292|NCT00415077|Procedure|MMC PRK|mitomycin C PRK
16331293|NCT00415077|Procedure|LASEK|LASEK
16331294|NCT00415064|Drug|Perifosine|Perifosine given in either 50 mg or 100 mg / day
16331295|NCT00415064|Drug|Lenalidomide|Lenalidomide given in either 15 or 25 mg / day
16331296|NCT00415064|Drug|Dexamethasone|Dexamethasone given in 20 mg / day
16331297|NCT00415051|Biological|RVF MP-12|Administer 1 ml SQ
16331298|NCT00415038|Drug|Rostafuroxin|1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
16331299|NCT00415038|Drug|Rostafuroxin|1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
16331300|NCT00415038|Drug|Rostafuroxin|1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
16331301|NCT00415038|Drug|Rostafuroxin|1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
16331302|NCT00415038|Drug|Rostafuroxin|1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
16331303|NCT00415025|Procedure|adjuvant therapy|
16331304|NCT00415025|Procedure|management of therapy complications|
16331305|NCT00415025|Procedure|quality-of-life assessment|
16331306|NCT00415025|Radiation|intensity-modulated radiation therapy|
16331307|NCT00414999|Drug|TG100801|
16331308|NCT00414986|Behavioral|Standard CQI intervention|In-practice change facilitator assists the practice in implementing a chronic disease registry
16331309|NCT00414986|Behavioral|Chronic Care Improvement (CCI) Intervention|An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.
16331310|NCT00414986|Behavioral|Self-directed practice comparison|Practices will have access to all tools used in Arm 1 via a project website
16331311|NCT00414973|Drug|Teriparatide|Subcutaneous, 20 micrograms/day, 24 weeks
16331312|NCT00414973|Drug|Salmon Calcitonin|Intranasal, 200 International Units (IU)/day, 24 weeks
16331313|NCT00414960|Drug|Enzastaurin|500 mg po QD for 6 months
16331314|NCT00414960|Drug|Placebo|po QD for 6 months
16331315|NCT00414947|Drug|Vildagliptin (LAF237)|
16331316|NCT00414921|Drug|clonidine|Clonidine is FDA-approved for the treatment of hypertension in adults
16331317|NCT00414921|Drug|methylphenidate|Methylphenidate is known to safely and effectively treat many ADHD symptoms.
16331318|NCT00414921|Other|placebo|inactive substance
16331319|NCT00414908|Drug|Pancrelipase delayed release capsule|24,000 unit capsule
16331320|NCT00414908|Drug|Placebo Comparator|Placebo
16331321|NCT00414869|Drug|NCX-1000|500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days
16331322|NCT00414869|Drug|Placebo|Inactive powder matching NCX-1000
16331323|NCT00414856|Drug|AFQ056|
16331324|NCT00414817|Behavioral|Automated Phone-Based Refill Reminders|The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
16331325|NCT00414804|Device|Precision SCS|Precision Spinal Cord Stimulation (SCS) Therapy
16331326|NCT00414804|Procedure|Nerve Blocks and PT|Pain therapy utilizing Nerve Blocks with Physical Therapy
16331327|NCT00414778|Drug|LHT344|
16331328|NCT00414765|Drug|Aldesleukin|
16331329|NCT00414752|Drug|AFQ065|
16331330|NCT00414739|Drug|Benzalkonium chloride|
16331331|NCT00414726|Drug|NBO (Normobaric Oxygen)|High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
16331332|NCT00414726|Drug|Room Air|Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
16331333|NCT00414713|Procedure|red blood cell transfusion|red blood cell transfusion
16331334|NCT00414700|Drug|ChondroCelect implantation|"10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.
~The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm²."
16331335|NCT00414700|Procedure|Microfracture|A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.
16331336|NCT00414687|Drug|Ventavis (Iloprost, BAYQ6256)|
16331337|NCT00414661|Drug|CP-690,550|Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.
16331338|NCT00414648|Drug|Sirolimus|A sirolimus dose of 2 mg will be given in the form of 2 tablets (1 mg/tablet) per day for 1 year.
16331339|NCT00414648|Drug|Placebo sirolimus|A placebo dose of 2 mg will be given in the form of 2 tablets (1 mg/tablet) per day for 1 year.
16331340|NCT00414635|Drug|Intermitent Dosing|"Intermittent dosing treatment is the maintenance of the 5/2 schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. ."
16331341|NCT00414622|Drug|DMXB-A|
16331342|NCT00414609|Drug|Aliskiren|Aliskiren was available in 75 mg tablet, 150 mg tablet
16331343|NCT00414609|Drug|placebo|Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.
16331344|NCT00414596|Device|DRX9000™|Device is designed to apply spinal decompressive forces.
16331345|NCT00414583|Other|No intervention|Observational study, only laboratory analysis and diagnostic interventions done; no drug tested
16331346|NCT00414570|Drug|[18]F-FLT PET scan|Injection of [18]F-FLT radiopharmaceutical followed by PET imaging.
16331347|NCT00414557|Procedure|Quadriceps strengthening|
16331348|NCT00414544|Device|CosmetaLife|Dermal filler
16331349|NCT00414544|Device|Restylane|Dermal filler
16331350|NCT00414531|Drug|Atorvastatin|20 to 80 mg per day
16331351|NCT00414518|Drug|Tenofovir disoproxil fumarate/Emtricitabine|300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
16331352|NCT00414518|Drug|Lopinavir/Ritonavir|Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
16331353|NCT00414505|Device|Intradermal Acupuncture Treatment|
16331354|NCT00414479|Drug|praziquantl, iron, ACT|
16331355|NCT00414466|Drug|Intraspinal Gabapentin|Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
16331356|NCT00414453|Drug|Lidocaine patch 5%|lidocaine 5% patch; 12 hours on, 12 hours off
16331357|NCT00414453|Drug|Extended-release oxycodone|extended-release oxycodone titrating schedule
16331358|NCT00414453|Drug|Placebo extended-release oxycodone pills|placebo pills with titrating schedule
16331359|NCT00414453|Drug|Placebo lidocaine patches|used with extended release oxycodone group; used with placebo pills/placebo patches
16331360|NCT00414440|Drug|Placebo|placebo comparator
16331361|NCT00414440|Drug|Everolimus|experimental
16331362|NCT00414427|Procedure|Intraarticular steroids|
16331363|NCT00414414|Drug|Prednisone|
16331364|NCT00414414|Drug|placebo|placebo
16331365|NCT00414401|Behavioral|Clinical Reminder|
16331366|NCT00414388|Drug|Sorafenib|400mg twice daily
16331367|NCT00414375|Procedure|Operation on Admission|Laparoscopic appendectomy on admission
16331368|NCT00414375|Procedure|Drainage and Interval Appendectomy|drainage with interval appendectomy
16331369|NCT00414349|Drug|Topical analgesic|max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
16331370|NCT00414349|Drug|oral intake|300 to 600 mg per day taken orally
16331371|NCT00414349|Drug|Topical analgesic|3 plasters for PHN patients per day 4 plasters for DPN patients per day
16331372|NCT00414336|Drug|AMA1-C1/Alhydrogel + CPG 7909 Vaccine|
16331373|NCT00414323|Drug|Duloxetine|
16331374|NCT00414323|Drug|Escitalopram|
16331375|NCT00414323|Drug|Placebo|
16331376|NCT00414310|Drug|Decitabine|20 mg/m^2 IV over 1 hour daily for 5 days.
16331377|NCT00414310|Drug|Valproic Acid|50 mg/kg orally daily for 7 days
16331378|NCT00414297|Device|ECP Therapy|application of ECP Therapy to CAD Patients
16331379|NCT00414284|Drug|Increased dose of Kaletra|
16331380|NCT00414271|Drug|Docetaxel|Docetaxel 60 mg/m2 IV on day 1
16331381|NCT00414271|Drug|Capecitabine|Capecitabine 900 mg/m2 PO two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
16331382|NCT00414258|Procedure|breastfeeding|See detailed description.
16331383|NCT00414245|Drug|metformin|
16331384|NCT00414219|Behavioral|Visual quality of patients with corneal eye injuries|Visual quality of patients with corneal eye injuries
16331385|NCT00414206|Drug|Mecamylamine|
16331386|NCT00414206|Drug|Placebo|
16331387|NCT00414180|Drug|Bupropion SR|
16331388|NCT00414167|Drug|bupropion|300 mg per day for 8 weeks
16331389|NCT00414167|Other|Placebo|Placebo
16331390|NCT00414154|Behavioral|Group based multidisciplinary patient education programme|
16331391|NCT00414141|Biological|Grass MATA MPL|4 subcutaneous injections
16331392|NCT00414141|Biological|Placebo|4 subcutaneous injections
16331393|NCT00414128|Drug|mycophenolate mofetil|2-3g/day for 3-6 months, in tablet, capsule or liquid form
16331394|NCT00414128|Drug|cyclophosphamide|intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)
16331395|NCT00414102|Drug|Ramelteon|Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.
16331396|NCT00414102|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.
16331397|NCT00414089|Drug|90Y-ibritumomab tiuxetan (Zevalin)|
16331398|NCT00414076|Drug|Letrozole|2.5 mg Tablet By Mouth Daily for 12 Weeks.
16331399|NCT00414050|Biological|Modified Process Hepatitis B Vaccine (Experimental)|Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).
16331400|NCT00414050|Biological|Hepatitis B Vaccine (Recombinant)|RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.
16331401|NCT00414050|Biological|Hepatitis B Vaccine (Recombinant)|ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
16331402|NCT00414037|Drug|Eszopiclone|
16331403|NCT00414037|Drug|Placebo|Placebo-treatment
16331404|NCT00414024|Drug|Tegaserod|
16331405|NCT00414011|Drug|Moxifloxacin|1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
16331406|NCT00414011|Drug|Gatifloxacin|1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
16331407|NCT00413998|Procedure|CABG + Mitral valve annuloplasty|Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
16331408|NCT00413998|Procedure|CABG|Patients will undergo coronary artery bypass grafting alone.
16331409|NCT00413985|Drug|Nutrient-enriched human milk|
16331410|NCT00413972|Drug|ezetimibe with simvastatin|Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks
16331411|NCT00413972|Drug|Ezetimibe with Simvastatin|Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks
16331412|NCT00413972|Drug|Ezetimibe with Simvastatin|Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks
16331413|NCT00413972|Drug|Placebo|Placebo once daily for a total of eight weeks
16331414|NCT00413959|Drug|VELCADE®|1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
16331739|NCT00411229|Drug|Oxaliplatin|IV infusion, 130mg/m²
16331415|NCT00413959|Drug|Rituximab|375 mg/m^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
16331416|NCT00413959|Drug|Cyclophosphamide|400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
16331417|NCT00413959|Drug|Decadron|40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
16331418|NCT00413946|Drug|Recombinant human Erythropoietin|3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight
16331419|NCT00413946|Drug|saline|three doses of 1.0 ml saline per body weight
16331420|NCT00413933|Procedure|Comprehensive Multidisciplinary Intervention|Comprehensive Multidisciplinary Intervention
16331421|NCT00413920|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
16331422|NCT00413920|Drug|Prednisone|Oral tablets
16331423|NCT00413894|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa
16331424|NCT00413881|Procedure|WAVEFRONT- GUIDED LASIK ENHANCEMENT|Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system
16331425|NCT00413881|Procedure|CONVENTIONAL LASIK ENHANCEMENT|Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.
16331426|NCT00413868|Procedure|LASIK|
16331427|NCT00413868|Procedure|PRK|
16331428|NCT00413868|Behavioral|Small target contrast sensitivity and disability glare|
16331429|NCT00413855|Procedure|laparoscopic appendectomy or not (surgery)|
16331430|NCT00413829|Drug|Intravitreal ranibizumab with photodynamic therapy|Intravitreal injection, photodynamic therapy
16331431|NCT00413803|Procedure|4-hour thrice weekly in center hemodialysis|conventional hemodialysis
16331432|NCT00413803|Procedure|8-hour thrice weekly in center hemodialysis|long dialysis
16331433|NCT00413790|Drug|Darifenacin|Darifenacin tablets 15 mg once daily
16331434|NCT00413790|Drug|Tolterodine|Tolterodine extended release (ER) 4 mg once daily
16331435|NCT00413790|Drug|Placebo|Placebo tablet once daily
16331436|NCT00413777|Drug|Tolvaptan|Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.
16331437|NCT00413764|Drug|tibolone|tibolone (2.5 mg) over 24 weeks
16331438|NCT00413764|Drug|estradiol-norethisterone|transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
16331439|NCT00413751|Drug|Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)|
16331440|NCT00413738|Device|Antiseptic-coated central venous catheters|
16331441|NCT00413725|Biological|MRKAd5 HIV-1 gag/pol/nef|Experimental Clade-B based Adenovirus serotype 5 HIV-1 gag/pol/nef vaccine
16331442|NCT00413725|Other|Placebo|Placebo
16331443|NCT00413712|Drug|Calcium Channel Blocker & Adenosine|
16331444|NCT00413699|Drug|CP-690,550|5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
16331445|NCT00413699|Drug|CP-690,550|10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
16331446|NCT00413686|Drug|AZD7762|intravenous infusion
16331447|NCT00413686|Drug|Gemcitabine|weekly intravenous infusion
16331448|NCT00413673|Procedure|PRK|PRK
16331449|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
16331450|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
16331451|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
16331452|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
16331453|NCT00413660|Drug|CP-690,550|4 blinded tablets administered BID
16331454|NCT00413660|Drug|CP-690,550|Oral tablets
16331455|NCT00413660|Other|placebo|Placebo
16331456|NCT00413647|Drug|CardioPET|
16331457|NCT00413634|Drug|anagrelide hydrochloride|Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.
16331458|NCT00413634|Drug|anagrelide hydrochloride|Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.
16331459|NCT00413608|Drug|Clopidogrel|Clopidogrel
16331460|NCT00413595|Other|No intervention|Observational, epidemiological, prognosis study; no drug tested; only laboratory analysis and diagnostic interventions done.
16331461|NCT00413582|Drug|Epidural Analgesia|Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max 5mg) and/or fentanyl 0.5 - 2 mcg/kg IV for comfort during the procedure. Once the epidural is placed, the patient will be positioned for surgery. The epidural catheter will be initially bolused with 0.3ml/kg of ropivacaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivacaine 0.10%, fentanyl 2mcg/ml and clonidine 1.5mcg/ml will be initiated immediately at the rate of 0.3ml/kg/hr (max 10ml/hr). Intraoperatively, patients will receive intravenous fentanyl if indicated.
16331515|NCT00413166|Drug|Arsenic Trioxide (ATO)|Induction: 0.15 mg/kg daily IV beginning day 1
16331516|NCT00413166|Drug|Idarubicin|"12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
~If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date."
16331462|NCT00413582|Drug|Patient-Controlled IV Analgesia|In the PCA arm, patients will receive fentanyl (3-6 mcg/kg) at anesthesia induction. Additional fentanyl may be administered intraoperatively as indicated. Patients who are > 35 Kg. (in keeping with current FDA approved labeling) will receive a clonidine 0.1 mg/day transdermal patch to the deltoid immediately after induction of anesthesia. Subjects in the epidural arm also receive clonidine. Upon arrival to the post anesthesia care unit, patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose). An additional hydromorphone dose (8mcg/kg) will be available every 2 hours for pain scores of > 4/10 throughout the duration of PCA use.
16331463|NCT00413569|Procedure|cervical spine surgery|
16331464|NCT00413556|Biological|ALK Grass tablet|
16331465|NCT00413543|Other|early pulmonary lung rehabilitation|early pulmonary rehabilitation, 10 days after discharge
16331466|NCT00413517|Procedure|Epi-Lasik|A vision correcting surgery
16331467|NCT00413504|Drug|Fondaparinux|
16331468|NCT00413491|Procedure|MR mammography|MR mammography
16331469|NCT00413491|Procedure|MR|MR
16331470|NCT00413478|Drug|5-Azacytidine|Starting dose level: 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
16331471|NCT00413465|Drug|Escherichia Coli Endotoxin|
16331472|NCT00413452|Drug|Etanercept|50 mg once weekly
16331473|NCT00413439|Drug|Isavuconazole|Intravenous solution or oral capsules
16331474|NCT00413426|Drug|Darifenacin (DAR328)|
16331475|NCT00413413|Drug|Valsartan/amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
16331476|NCT00413413|Drug|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
16331477|NCT00413413|Drug|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
16331478|NCT00413400|Drug|Etanercept|50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months
16331479|NCT00413400|Drug|Placebo|50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months
16331480|NCT00413387|Drug|beclomethasone dipropionate plus formoterol fumarate combination|100mcg beclomethasone diproprionate plus 6 mcg formoterol
16331481|NCT00413387|Drug|budesonide plus formoterol combination|200mcg budesonide plus 6 mcg formoterol
16331482|NCT00413374|Drug|Enoxaparin|Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.
16331483|NCT00413361|Drug|versus hydroxychloroquine|versus hydroxychloroquine
16331484|NCT00413348|Drug|Lactobacillus acidophilus NCFM|
16331485|NCT00413335|Drug|Rosiglitazone|2mg to begin then 4mg, twice daily for 4 months
16331486|NCT00413335|Drug|Placebo|Subject receives placebo.
16331487|NCT00413322|Drug|belinostat|300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
16331488|NCT00413322|Drug|5-Fluorouracil (5-FU)|250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.
16331489|NCT00413309|Procedure|Video Capsule Endoscopy|Noninvasive pill endoscopy is undertaken after 90 days of Aspirin/Clopidogrel in patients who have had percutaneous coronary intervention with drug-eluting stents.
16331490|NCT00413296|Drug|levetiracetam|Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
16331491|NCT00413296|Drug|Placebo|Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
16331492|NCT00413296|Drug|Levetriracetam|Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study.
16331493|NCT00413283|Biological|Romiplostim|Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
16331494|NCT00413283|Drug|Placebo|Placebo subcutaneous injection.
16331495|NCT00413283|Drug|Gemcitabine|Intravenous infusion
16331496|NCT00413283|Drug|Carboplatin|Intravenous infusion
16331497|NCT00413283|Drug|Cisplatin|Intravenous infusion
16331498|NCT00413270|Drug|nilotinib|
16331499|NCT00413257|Drug|Nefopam|0,3mg/kg IV bolus preoperative and 65 µg/kg/h during H48 postoperative
16331500|NCT00413257|Drug|néfopam|bolus Néfopam (0,3mg/kg) during 10 min at the end of surgery and 65 µg/kg/h during postoperative H48
16331501|NCT00413257|Drug|Placebo comparator|bolus NaCl during 10 min at the end of surgery and during postoperative H48
16331502|NCT00413244|Drug|AndroGel 5 Grams|"Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
~Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months."
16331503|NCT00413244|Drug|Placebo|"Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
~Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months."
16331504|NCT00413231|Device|Valiant Thoracic Stent Graft System|Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
16331505|NCT00413218|Drug|Isavuconazole|Administered by intravenous infusion.
16331506|NCT00413218|Drug|Caspofungin|Administered by intravenous infusion.
16331507|NCT00413218|Drug|Voriconazole|Administered by intravenous infusion.
16331508|NCT00413205|Drug|Placebo|po daily
16331509|NCT00413205|Drug|RAR Gamma|5mg po daily
16331510|NCT00413192|Drug|E7389|1.4 mg/m^2 administered as an intravenous (I.V.) bolus infusion on Days 1 and 8 of every 21 days.
16331511|NCT00413179|Drug|Metformin|
16331512|NCT00413179|Drug|Clomiphene citrate|
16331513|NCT00413179|Drug|Placebo|
16331514|NCT00413166|Drug|All-Trans Retinoic Acid (ATRA)|Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1
16331517|NCT00413166|Drug|Gemtuzumab Ozogamicin|Induction: 9 mg/m2 on day 1 of induction
16331518|NCT00413153|Drug|atazanavir/ritonavir|atazanavir 300mg + ritonavir 100mg once daily
16331519|NCT00413153|Drug|lopinavir/ritonavir|patient remains on their pre-study dose of lopinavir/ritonavir
16331520|NCT00413127|Drug|lidocaine|administration of lidocaine intravenously or epidural or administration of placebo
16331521|NCT00413127|Drug|NaCl 0,9%|Administration of placebo i.v.
16331522|NCT00413114|Drug|Obatoclax mesylate (GX15-070MS)|
16331523|NCT00413101|Drug|epoetin beta [NeoRecormon]|At a dose to achieve and maintain an Hb level of 120-135g/L
16331524|NCT00413088|Drug|bemiparin|
16331525|NCT00413075|Drug|oral belinostat|oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules.
16331526|NCT00413062|Drug|NOMAC-E2|Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
16331527|NCT00413062|Drug|DRSP-EE|Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
16331528|NCT00413049|Drug|Valsartan/amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
16331529|NCT00413049|Drug|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
16331530|NCT00413036|Drug|lenalidomide|once daily oral capsule
16331531|NCT00413023|Drug|GW679769|
16331532|NCT00413010|Drug|pregabalin|pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period
16331533|NCT00413010|Drug|placebo|placebo + concurrent GAD treatment from the open-label study period
16331534|NCT00412997|Drug|LBH589|
16331535|NCT00412984|Drug|warfarin|Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
16331536|NCT00412984|Drug|apixaban|Oral tablets, 5.0 mg or 2.5 mg, twice daily
16331537|NCT00412971|Drug|Hexvix|Single installation, TURB
16331538|NCT00412971|Other|Standard white light cystoscopy|
16331539|NCT00412958|Drug|Ocriplasmin 25µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
16331540|NCT00412958|Drug|Ocriplasmin 75µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
16331541|NCT00412958|Drug|Ocriplasmin 125µg|Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
16331542|NCT00412958|Drug|Placebo|Intravitreal injection of placebo
16331543|NCT00412932|Drug|Olmesartan medoxomil|Tablets
16331544|NCT00412932|Drug|Olmesartan medoxomil/hydrochlorothiazide|Tablets
16331545|NCT00412919|Drug|Azacitidine|
16331546|NCT00412906|Drug|Escherichia Coli Endotoxin|
16331547|NCT00412893|Drug|Isavuconazole|Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
16331548|NCT00412893|Drug|Voriconazole|Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
16331549|NCT00412880|Drug|BI 2536|
16331550|NCT00412867|Drug|Alteplase|0.6 mg/kg of Alteplase is intravenously administered
16331551|NCT00412854|Biological|Infanrix™/Hib|
16331552|NCT00412854|Biological|Infanrix|
16331553|NCT00412854|Biological|Hiberix|
16331554|NCT00412841|Drug|Atorvastatin|Atorvastatin 40mg vs placebo 40mg daily
16331555|NCT00412841|Procedure|MRI, Venipuncture|MRIs done baseline, four and nine months
16331556|NCT00412841|Drug|Placebo|Tablets identical to atorvastatin 40mg
16331557|NCT00412828|Drug|CR011-vcMMAE|administered as an intravenous infusion of 250 mL over 90 min
16331558|NCT00412815|Behavioral|Exercise training|
16331559|NCT00412802|Drug|dose adaptation of Enoxaparin|A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.
16331560|NCT00412802|Drug|normal injection of Enoxaparine|No dose adaptation of Enoxaparine
16331561|NCT00412789|Drug|Patupilone|
16331562|NCT00412776|Drug|Proxinium|700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
16331563|NCT00412763|Drug|Silymarin (Silybum marianum)|
16331564|NCT00412750|Drug|Telbivudine (LdT)|600 mg orally once daily for 104 weeks.
16331565|NCT00412750|Drug|peginterferon alpha-2a|180 μg subcutaneous injection once a week for 52 weeks.
16331566|NCT00412737|Drug|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
16331567|NCT00412737|Drug|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
16331568|NCT00412698|Drug|rimonabant|"Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning.
~White film-coated tablets, for oral administration containing 20 mg of active rimonabant"
16331569|NCT00412698|Drug|Placebo|Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.
16331570|NCT00412659|Procedure|Surgery for pilonidal disease, midline excision|A midline excision is made for the treatment of pilonidal sinus disease.
16331571|NCT00412659|Procedure|Surgery for pilonidal disease, Karydakis operation|A Karydakis operation is done for the treatment of pilonidal sinus disease.
16331572|NCT00412646|Drug|TMC125|
16331573|NCT00412633|Behavioral|Diet and physical activity interventions|Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
16331680|NCT00411749|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)|V501; Gardasil, 0.5 ml injection in 3 dosing regimen
16331574|NCT00412633|Behavioral|Computer technology to tailor, promote and sustain health behavior change & improve health care delivery.|Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
16331575|NCT00412620|Drug|ABT-925|
16331576|NCT00412620|Drug|Placebo|
16331577|NCT00412607|Device|NAVISTAR® THERMOCOOL® Catheter|The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease
16331578|NCT00412594|Drug|Cladribine|Given IV
16331579|NCT00412594|Other|Laboratory Biomarker Analysis|Correlative studies
16331580|NCT00412594|Biological|Rituximab|Given IV
16331581|NCT00412581|Drug|Lenalidomide|25 mg by mouth daily for 2 weeks, followed by 1 week of rest.
16331582|NCT00412581|Drug|Dacarbazine|600 mg/m^2 intravenously on Day 1 of every study cycle.
16331583|NCT00412568|Procedure|Photorefractive Keratectomy (PRK)|vision correction with PRK
16331584|NCT00412555|Drug|oseltamivir [Tamiflu]|30-75mg po daily for 6 weeks
16331585|NCT00412542|Drug|Thalidomide|100 mg PO (by mouth) daily for 8 weeks
16331586|NCT00412542|Drug|CPT-11|125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest
16331587|NCT00412542|Procedure|MRI Scan|Dynamic MRI scan with dye injection through vein, every 6 weeks
16331588|NCT00412542|Procedure|Quantitative Sensory Tests (QST)|QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.
16331589|NCT00412529|Drug|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
16331590|NCT00412529|Drug|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
16331591|NCT00412516|Biological|Live attenuated SA 14-14-2 vaccine|Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
16331592|NCT00412503|Drug|Topotecan, Temozolomide|
16331593|NCT00412490|Behavioral|Questionnaire|Written survey at 1 Month & 6 Months post surgery.
16331594|NCT00412490|Behavioral|Interview|One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.
16331595|NCT00412477|Biological|HIV LFn-p24|HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel.
16331596|NCT00412464|Drug|Fondaparinux|Fondaparinux 0.1 mg/kg (up to 7.5 mg max initial dose) once daily for up to 21 days.
16331597|NCT00412451|Drug|ocriplasmin|Intravitreal injection, single administration
16331598|NCT00412451|Other|Sham injection|Sham intravitreal injection
16331599|NCT00412425|Drug|Palonosetron|0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.
16331600|NCT00412412|Drug|CNF2024|Oral doses of CNF2024 as specified in the protocol.
16331601|NCT00412412|Drug|CNF2024 + trastuzumab|Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.
16331602|NCT00412373|Drug|Placebo|for 6 weeks
16331603|NCT00412373|Drug|Paliperidone ER|(3-12mg/day in 3 mg/day increments for 6 weeks)
16331604|NCT00412373|Drug|Paliperidone ER|(3-12mg/day in 3 mg/day increments for 6 weeks)
16331612|NCT00412347|Drug|Insulin Drip Therapy|
16331613|NCT00412334|Drug|Copegus|1200-1600mg/day po
16331614|NCT00412334|Drug|Copegus|1000-1200mg/day po
16331615|NCT00412334|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly
16331616|NCT00412334|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc twice weekly
16331617|NCT00412321|Drug|CNTO 328|Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.
16331618|NCT00412308|Procedure|Tidal volume used in mechanical ventilation|
16331619|NCT00412295|Device|Alcon Ladarvision (Wavefront-guided PRK)|Wavefront-guided PRK using Alcon Ladarvision
16331620|NCT00412256|Drug|Omegaven (10% fish-oil emulsion; Fresenius-Kabi)|
16331621|NCT00412243|Drug|Clofarabine|40 mg/m^2 Daily for 3 Days
16331622|NCT00412243|Drug|Cyclophosphamide|Beginning dose 200 mg/m^2 every 12 hours for 3 days
16331623|NCT00412217|Drug|Placebo|Participants will receive placebo tablets (matched to erlotinib) once daily.
16331624|NCT00412217|Drug|Erlotinib|Erlotinib will be given as 150 mg PO once daily.
16331625|NCT00412217|Other|Standard of care|Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
16331626|NCT00412204|Drug|tiotropium bromide|Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.
16331627|NCT00412204|Other|Placebo|Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.
16331628|NCT00412191|Drug|Lamotrigine|In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
16331629|NCT00412178|Device|telecommunication based glucose monitoring system|
16331630|NCT00412165|Behavioral|Cell Phone|The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
16331631|NCT00412165|Behavioral|Weekly access to interactive web site|This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
16331632|NCT00412165|Behavioral|Group|The Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
16331633|NCT00412152|Drug|Oxycodone nalaxone prolonged release tablets (OXN)|
16331634|NCT00412126|Drug|Insulin|
16331635|NCT00412113|Drug|Amlodipine besylate|Amlodipine besylate 5 mg
16331636|NCT00412113|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Amlodipine/atorvastatin single pill combination 10/20 mg
16331637|NCT00412113|Drug|Amlodipine besylate|Amlodipine besylate 10 mg
16331638|NCT00412113|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Amlodipine/atorvastatin single pill combination 5/20 mg
16331639|NCT00412100|Drug|Oxycodone naloxone prolonged release tablets (OXN)|
16331640|NCT00412087|Drug|cholecalciferol (vitamin D3)|randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day
16331641|NCT00412087|Drug|cholecalciferol|randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3
16331642|NCT00412087|Drug|cholecalciferol|cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
16331643|NCT00412074|Drug|400 IU Vitamin D3 (cholecalciferol)|400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
16331644|NCT00412074|Drug|2400 IU Vitamin D3 (cholecalciferol)|2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
16331645|NCT00412074|Drug|6400 IU Vitamin D3 (cholecalciferol)|6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
16331646|NCT00412061|Drug|Octreotide|Octreotide 30 mg intramuscularly (i.m.) every 28 days.
16331647|NCT00412061|Drug|Placebo|A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
16331648|NCT00412061|Drug|Everolimus|A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
16331649|NCT00412048|Procedure|fMRI to detect MCI patients who will convert to Alzheimer's disease|There is a fMRI to be realized in the 3 arms. No drug is administered
16331650|NCT00412035|Drug|Botulinum toxin A injection|10 units per kilo to maximum of 400 units
16331651|NCT00412035|Drug|saline injection|10 units per kilo to maximum of 400 units
16331652|NCT00412022|Drug|tamoxifen|20 mg daily for 5 years
16331653|NCT00412022|Drug|triptorelin|Premenopausal patients will receive triptorelin 3.75 mg IM at the beginning of therapy and every 4 weeks for 5 years or up to age 55
16331654|NCT00412022|Drug|letrozole|2.5 mg daily for 5 years
16331655|NCT00412022|Drug|zoledronic acid|4 mg every 6 months
16331656|NCT00412009|Procedure|Comprehensive package of activities|
16331657|NCT00411996|Drug|indinavir/ritonavir|IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
16331658|NCT00411970|Device|20- and 23 gauge vitreoretinal surgery systems|
16331659|NCT00411957|Drug|Atazanavir|ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
16331660|NCT00411931|Drug|Multihance|0.5M administered as a single injection
16331661|NCT00411905|Drug|Bortezomib|
16331662|NCT00411892|Drug|pioglitazone|Tablets, 45 mg/day.
16331663|NCT00411892|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16331664|NCT00411879|Drug|Vasopressin, Epinephrine, and Steroids|During resuscitation, study group patients receive vasopresssin [20 IU IV maximum dose = 100 IU] and methylprednisolone (40 mg IV). Epinephrine is given to both groups according to guidelines for resuscitation 2005. In the study group, postresuscitation shock is treated with stress-dose hydrocortisone.
16331665|NCT00411879|Drug|Placebo, Epinephrine, Placebo|Epinephrine is given to both groups according to guidelines for resuscitation 2005. Control group patients receive placebo instead of vasopressin and steroids.
16331666|NCT00411866|Drug|SB773812|SB-773812 20 mg will be available as white round film coated tablets.
16331667|NCT00411866|Drug|Ketoconazole|Ketoconazole will be available as 200mg tablets.
16331668|NCT00411853|Drug|Fermented Wheat germ extract|Fermented Wheat Germ powder, given orally, per os, 17 gram daily
16331669|NCT00411840|Procedure|intraarterial and intramuscular injection of BMCs|
16331670|NCT00411827|Procedure|PRK with conjunctival impression cytology before and after surgery|
16331671|NCT00411827|Procedure|LASIK with conjunctival impression cytology before and after surgery|LASIK with conjunctival impression cytology before and after surgery
16331672|NCT00411814|Drug|GSK679586|Active Drug
16331673|NCT00411814|Drug|Placebo|Saline
16331674|NCT00411801|Biological|Uniplas|Uniplas will be provided frozen in sterile plastic bags.
16331675|NCT00411801|Biological|Cryosupernatant plasma|Cryosupernatant plasma will be provided frozen in sterile plastic bags.
16331676|NCT00411788|Drug|Rapamycin|oral rapamycin 6 mg daily
16331677|NCT00411788|Drug|Trastuzumab|Trastuzumab 4 mg/kg will be administered (intravenous) on day 1, and this will be followed by weekly dose of 2 mg/kg starting day 8.
16331678|NCT00411762|Drug|Capecitabine|
16331679|NCT00411762|Drug|PHY906|
16336559|NCT00375765|Drug|Dutasteride|
16331681|NCT00411749|Biological|Comparator: Placebo (unspecified)|Placebo 0.5 ml injection in 3 dosing regimen
16331682|NCT00411736|Drug|Study medication, azithromycin or placebo|Granulate for syrup in the group under 8 years, 40 mg/ml. Dose: 5 mg/kg/day in one daily dose.
16331683|NCT00411736|Drug|Azithromycin or placebo tablets|Tablets of 250 mg, azithromycin or placebo. Dosage: 1 tablet every other day for participants with a weight less than 40 kg´s. 1 tablet every day for participants weighing 40 kg´s or more.
16331684|NCT00411723|Drug|RTL1000 (recombinant T cell receptor ligand)|Dosage form: IV infusion. Dosage: Single dose @ 2, 6, 20, 60, 100 or 200mg. Duration: 1 - 2 hours.
16331685|NCT00411723|Drug|RTL1000 Placebo|Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.
16331686|NCT00411697|Biological|Engerix™-B Kinder|Intramuscular injection, 1 dose
16331687|NCT00411684|Drug|CDB-2914|
16331688|NCT00411671|Drug|Sorafenib|400 mg By Mouth Twice Daily for 28 Days.
16331689|NCT00411658|Device|Investigational Device|
16331690|NCT00411658|Device|Experimental|
16331691|NCT00411658|Other|Cryopreserved|
16331692|NCT00411645|Drug|maribavir|100 mg twice daily for up to 12 weeks
16331693|NCT00411645|Other|placebo|twice daily for up to 12 weeks
16331694|NCT00411632|Drug|Bexarotene|400 mg/m^2 by mouth daily x 28 Days
16331695|NCT00411632|Drug|Erlotinib|150 mg by mouth daily x 28 Days
16331696|NCT00411619|Drug|Everolimus|Initial everolimus dosage will be 3 mg/m2/d taken daily or every other day, with titration to achieve a trough serum level of 5-15 ng/ml. Patients unable to tolerate levels in this range will have doses held or reduced 25% to achieve trough serum levels of 5-10 ng/ml. If trough serum level of 5-15 ng/ml is not achieved at a dosage of 3 mg/m2/d, then dosage escalation by 25% will be undertaken as tolerated. Everolimus will be similarly adjusted during the extension phase. If a subject misses more than 10 consecutive everolimus doses, additional days of everolimus treatment will be added so total duration of treatment is 6 months. If this occurs, dates of subsequent study events will be adjusted according to number of missed doses. This process will also be followed in the extension phase.
16331697|NCT00411606|Procedure|Thermography|Subjects will have a picture of their face taken with a thermal camera
16331698|NCT00411593|Drug|Bevacizumab|15 g/kg by vein every 3 weeks on day 1 of each cycle.
16331699|NCT00411593|Drug|Bortezomib|"Phase I Starting dose: 1.6 mg/m2 by vein on days 1, 8 of each 3 week cycle.
~Phase II: MTD from Phase I."
16331700|NCT00411580|Biological|CAD106|
16331701|NCT00411580|Drug|Placebo|
16331702|NCT00411567|Drug|inhaled corticosteroid therapy|
16331703|NCT00411554|Drug|sitagliptin phosphate|sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
16331704|NCT00411554|Drug|Comparator: voglibose|voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
16331705|NCT00411541|Drug|vincristine|
16331706|NCT00411541|Drug|dexamethasone|
16331707|NCT00411528|Drug|Patupilone|
16331708|NCT00411528|Drug|prednisone|
16331709|NCT00411528|Drug|docetaxel|
16331710|NCT00411515|Drug|Mycophenolate Mofetil 2x 1g|
16331711|NCT00411489|Procedure|endolumenal surgery|
16331712|NCT00411463|Behavioral|Interpersonal and Social Rhythm Therapy (IPSRT-BPII)|"IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
16331713|NCT00411463|Drug|Seroquel|"Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder."
16331714|NCT00411450|Biological|Panitumumab|Administered by intravenous infusion
16331715|NCT00411450|Drug|FOLFIRI|Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
16331716|NCT00411437|Drug|Tolterodine ER|
16331717|NCT00411437|Drug|Oxybutynin ER|
16331718|NCT00411424|Drug|ASK8007|IV
16331719|NCT00411424|Drug|Placebo|IV
16331720|NCT00411411|Drug|Januvia|200 mg t.i.d
16331721|NCT00411411|Drug|Placebo|Placebo
16331722|NCT00411398|Drug|Namenda/Memantine|5mg tablets, 1-4 tabs by mouth per day
16331723|NCT00411385|Drug|albumin interferon alfa-2b|900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
16331724|NCT00411385|Drug|peginterferon alfa-2a|180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
16331725|NCT00411385|Drug|Ribavirin|800mg/day for 24 weeks
16331726|NCT00411372|Drug|fluticasone propionate/salmeterol 250/50mcg combination, salmeterol 50mcg|
16331727|NCT00411359|Behavioral|Cardiac rehabilitation|Phase III cardiac rehabilitation programme
16331728|NCT00411346|Procedure|Nurse-led telemonitoring|
16331729|NCT00411333|Drug|triamcinolone acetonide (Kenalog)|
16331730|NCT00411320|Drug|oral steroid-dexamethasone|2 week steroid trial
16331731|NCT00411307|Drug|OROS hydromorphone HCI|
16331732|NCT00411281|Drug|cytarabine|Given subcutaneously
16331733|NCT00411281|Procedure|observation|No intervention
16331734|NCT00411268|Drug|OROS hydromorphone HCI SR (slow release)|
16331735|NCT00411255|Procedure|repetitive transcranial magnetic stimulation (rTMS)|Three arms on three different days 180 stimuli will be delivered to the AC with a sham coil, with the H-coil and with a standard circular coil in separate sessions.
16331736|NCT00411242|Drug|agomelatine|
16331737|NCT00411242|Drug|placebo|
16331738|NCT00411229|Drug|Capecitabine|1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
16331740|NCT00411216|Other|Control exercises|saccadic eye movements against a plain background; no head movements
16331741|NCT00411216|Other|gaze stabilization exercises|adaptation and substitutin exercises encorporating retinal lsip and head movements
16331742|NCT00411203|Drug|Tamoxifen Citrate|
16331743|NCT00411203|Drug|Placebo|
16331744|NCT00411190|Drug|Relacatib|Subjects will administer 60 or 120 mg tablets in Session 2
16331745|NCT00411190|Drug|Acetaminophen|Acetaminophen will be administered orally
16331746|NCT00411190|Drug|Ibuprofen|Ibuprofen will be administered orally
16331747|NCT00411190|Drug|Atorvastatin|Atorvastatin will be administered orally
16331748|NCT00411177|Procedure|post-dilution on-line hemodiafiltration|post-dilution on-line hemodiafiltration, 3 times a week 4 hours
16331749|NCT00411177|Procedure|high flux hemodialysis|High-flux hemodialysis, 3 times a week 4 hours
16331750|NCT00411164|Drug|OROS hydromorphone HCI (slow release)|
16331751|NCT00411151|Drug|Sunitinib-Malate|Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects
16331752|NCT00411138|Radiation|Radiation Therapy|External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
16331753|NCT00411138|Drug|cisplatin|cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
16331754|NCT00411138|Drug|carboplatin|carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
16331755|NCT00411138|Drug|Paclitaxel|paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
16331756|NCT00411125|Drug|Oral salmon calcitonin|
16331757|NCT00411112|Procedure|blue and isotopic detection of sentinel lymph nodes|
16331758|NCT00411099|Drug|agomelatine|
16331759|NCT00411099|Drug|placebo|
16331760|NCT00411086|Biological|Rituximab|375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.
16331761|NCT00411086|Biological|Sargramostim (GM-CSF)|250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
16331762|NCT00411073|Drug|Darapladib|
16331763|NCT00411047|Drug|gefitinib|oral drug taken daily around the same time
16331764|NCT00411034|Drug|OROS Hydromorphone HCI|
16331765|NCT00411021|Procedure|Pipelle (Endometrial Sampling)|
16331766|NCT00410995|Drug|Naproxen|
16331767|NCT00410982|Drug|Busulfan|Day -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous
16331768|NCT00410982|Drug|Gemcitabine|Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
16331769|NCT00410982|Drug|Melphalan|Day -3 and Day -2 = 60 mg/m^2 Intravenous.
16331770|NCT00410982|Other|Hematopoietic Cell Transplantation|Infusion of stem cells on Day 0.
16331771|NCT00410982|Drug|Rituximab for Patients with B-Cell Malignancies|375 mg/m^2 Intravenous on Days 1 and 8.
16331772|NCT00410982|Drug|Palifermin|60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
16331773|NCT00410969|Device|ThermoSuit(R) System|The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.
16331774|NCT00410956|Biological|bevacizumab|
16331775|NCT00410956|Drug|dexamethasone|
16331776|NCT00410956|Drug|floxuridine|
16331777|NCT00410956|Genetic|protein expression analysis|
16331778|NCT00410956|Other|flow cytometry|
16331779|NCT00410956|Other|immunoenzyme technique|
16331780|NCT00410956|Other|immunohistochemistry staining method|
16331781|NCT00410956|Other|immunologic technique|
16331782|NCT00410956|Other|laboratory biomarker analysis|
16331783|NCT00410956|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16331784|NCT00410943|Drug|OROS Hydromorphone HCI SR (slow release)|
16331785|NCT00410930|Biological|Subcutaneous immunotherapy - Recombinant birch pollen|
16331786|NCT00410904|Drug|cediranib maleate|
16331787|NCT00410904|Drug|pemetrexed disodium|
16331788|NCT00410891|Drug|gatifloxacin|
16331789|NCT00410878|Drug|OROS Hydromorphone HCI (slow release)|
16331790|NCT00410865|Genetic|INGN 201|Mouth rinse given one time on the first day and two times on Days 2-5 of each course of INGN 201. The injection and rinse (first day of each cycle), or the two rinses (Days 2-5 of each cycle), will be separated by at least two hours.
16331791|NCT00410852|Procedure|Computer-assisted IV insulin infusion protocol (algorithm A)|Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl.
16331792|NCT00410852|Procedure|Leuven Strict glycemic control protocol (Algorithm B)|Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.
16331793|NCT00410852|Procedure|Conventional Intermittent Insulin Protocol (Algorithm C)|Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl.
16331794|NCT00410839|Procedure|ALA rich diet|
16331795|NCT00410826|Drug|erlotinib hydrochloride|Given orally
16331796|NCT00410826|Drug|cisplatin|Given IV
16331797|NCT00410826|Radiation|3-dimensional conformal radiation therapy|35 fractions
16331798|NCT00410826|Radiation|intensity-modulated radiation therapy|35 fractions
16331799|NCT00410826|Procedure|quality-of-life assessment|Ancillary studies
16331800|NCT00410813|Drug|dasatinib|given orally
16331801|NCT00410787|Drug|OROS hydromorphone HCI (slow release)|
16331802|NCT00410774|Biological|bevacizumab|
16331803|NCT00410774|Drug|gemcitabine hydrochloride|
16331804|NCT00410774|Procedure|adjuvant therapy|
16331805|NCT00410761|Drug|ZD6474 (Vandetanib)|once daily oral tablet
16331806|NCT00410748|Drug|OROS hydromorphone HCI CR|
16331807|NCT00410735|Drug|Placebo|0 mg BID for 12 weeks
16331808|NCT00410735|Drug|Pranlukast hydrate|225 mg BID for 12 weeks
16331809|NCT00410722|Dietary Supplement|Whole wheat and bran muffin|
16331810|NCT00410722|Dietary Supplement|Mixed tree nuts|
16331811|NCT00410709|Drug|NatrOVA Creme Rinse (1%)|
16331812|NCT00410696|Drug|Filgrastim|5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
16331813|NCT00410696|Drug|Pegfilgrastim|6 mg/day sc at day +1
16331814|NCT00410683|Other|clinical observation|
16331815|NCT00410683|Procedure|adjuvant therapy|
16331816|NCT00410683|Radiation|3-dimensional conformal radiation therapy|
16331817|NCT00410657|Biological|alemtuzumab|
16331818|NCT00410657|Drug|methylprednisolone|
16331819|NCT00410657|Drug|prednisone|
16331820|NCT00410657|Other|flow cytometry|
16331821|NCT00410657|Other|immunologic technique|
16331822|NCT00410657|Other|pharmacological study|
16331823|NCT00410644|Drug|OROS Hydromorphone HCI|
16331824|NCT00410631|Biological|filgrastim|
16331825|NCT00410631|Drug|carboplatin|
16331826|NCT00410631|Drug|cisplatin|
16331827|NCT00410631|Drug|cyclophosphamide|
16331828|NCT00410631|Drug|dacarbazine|
16331829|NCT00410631|Drug|doxorubicin hydrochloride|
16331830|NCT00410631|Drug|etoposide phosphate|
16331831|NCT00410631|Drug|ifosfamide|
16331832|NCT00410631|Drug|isotretinoin|
16331833|NCT00410631|Drug|melphalan|
16331834|NCT00410631|Drug|topotecan hydrochloride|
16331835|NCT00410631|Drug|vincristine sulfate|
16331836|NCT00410631|Drug|vindesine|
16331837|NCT00410631|Procedure|autologous hematopoietic stem cell transplantation|
16331838|NCT00410631|Procedure|conventional surgery|
16331839|NCT00410631|Procedure|peripheral blood stem cell transplantation|
16331840|NCT00410631|Radiation|iobenguane I 131|
16331841|NCT00410631|Radiation|radiation therapy|
16331842|NCT00410618|Procedure|cognitive assessment|
16331843|NCT00410618|Procedure|magnetic resonance imaging|
16331844|NCT00410618|Procedure|management of therapy complications|
16331845|NCT00410605|Biological|bevacizumab|Given IV
16331846|NCT00410605|Drug|lenalidomide|Given orally
16331847|NCT00410605|Drug|dexamethasone|Given orally
16331848|NCT00410592|Drug|Esomeprazole 40mg|
16331849|NCT00410592|Drug|Pantoprazole 40mg|
16331850|NCT00410592|Drug|Lansoprazole 30mg|
16331851|NCT00410579|Other|Telephone interview|Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)
16331852|NCT00410566|Drug|rhASM|Single dose of 0.03mg/kg body weight IV
16331853|NCT00410566|Drug|rhASM|Single dose of 0.1mg/kg body weight IV
16331854|NCT00410566|Drug|rhASM|Single dose of 0.3mg/kg body weight IV
16331855|NCT00410566|Drug|rhASM|Single dose of 0.6mg/kg body weight IV
16331856|NCT00410566|Drug|rhASM|Single dose of 1.0mg/kg body weight IV
16331857|NCT00410553|Drug|Eribulin Mesylate|Given IV
16331858|NCT00410553|Drug|Gemcitabine Hydrochloride|Given IV
16331859|NCT00410540|Drug|OROS hydromorphone HCL ; Morphine sulfate|
16331860|NCT00410527|Drug|Merrem|
16331861|NCT00410514|Drug|Mirabegron|oral
16331862|NCT00410514|Drug|Placebo|oral
16331863|NCT00410501|Drug|Indacaterol (QAB149)|
16331864|NCT00410488|Drug|Palonosetron - Single Dose|0.25 mg by vein for 1 dose (day 0).
16331865|NCT00410488|Drug|Palonosetron - Triple Dose|0.25 mg by vein for 3 doses (days 0, 2, 4).
16331866|NCT00410488|Drug|Adriamycin|75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
16331867|NCT00410488|Drug|Ifosfamide chemotherapy (AI)|Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
16331868|NCT00410488|Drug|Zinecard|750 mg/m2 as an IV bolus.
16331869|NCT00410488|Drug|Mesna|500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
16331870|NCT00410488|Drug|Vincristine|"2 mg IV by rapid administration on day 0 (for patients with small cell histology).
~For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only."
16331871|NCT00410488|Drug|Dexamethasone|IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
16331872|NCT00410462|Drug|brostallicin|
16331873|NCT00410462|Drug|doxorubicin hydrochloride|
16331874|NCT00410449|Drug|Alpha tocopherol|
16331875|NCT00410436|Behavioral|Resistance Exercise|Subjects demonstrating adequate compliance during the run-in period will then be randomized in equal numbers to Resistance Training (R) 3X/week progressing to 3 sets, 8 repetitions of 8 exercises at the maximum load that can be lifted 8 times in a controlled manner, maintaining proper form (8RM), or waiting-list control (C).
16331876|NCT00410423|Drug|Bortezomib with mitoxantrone, etoposide and cytarabine|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
16331877|NCT00410423|Drug|Bortezomib 1.0mg/m^2|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
16331878|NCT00410423|Drug|Bortezomib 1.3mg/m^2|All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
16331879|NCT00410410|Drug|abatacept (ABA)|"Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57 (ABA 30/~10 mg/kg Group).
~Induction Period 3 months
~Maintenance Period 12 months"
16331880|NCT00410410|Drug|placebo|"Normal saline, IV, 0 mg/kg, every 28 days.
~Induction Period 3 months
~Maintenance Period 12 months"
16331881|NCT00410410|Drug|abatacept|"~10 mg/kg, once monthly
~Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued"
16331882|NCT00410397|Procedure|Osteopathic Manipulative Medicine|Pelvic balancing, myofascial release of the anterior pelvis.
16331883|NCT00410397|Procedure|Sham Manipulation|Neutral positional, gentle palpation
16331884|NCT00410384|Drug|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16331885|NCT00410384|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16331886|NCT00410384|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16331887|NCT00410371|Drug|Lamotrigine|Lamotrigine
16331888|NCT00410371|Drug|GI267119|25 mg ODT
16331889|NCT00410358|Drug|Gimatecan|
16331890|NCT00410345|Drug|Mifepristone|
16331891|NCT00410332|Drug|Traumeel S|homeopathic remedy
16331892|NCT00410332|Drug|Placebo|placebo drug, identical in size, form and taste as treatment remedy
16331893|NCT00410319|Behavioral|Fear-reducing Information|
16331894|NCT00410319|Behavioral|Symptom-based exercise|
16331895|NCT00410306|Drug|Testosterone Undecanoate (Nebido, BAY86-5037)|Patients from routine practice
16331896|NCT00410293|Procedure|NT-proBNP testing|
16331897|NCT00410280|Biological|IMA-638 is a biologic|
16331898|NCT00410254|Drug|HCV-796|
16331899|NCT00410254|Drug|midazolam|
16331900|NCT00410228|Drug|AHT956|
16331901|NCT00410215|Drug|picosalax plus bisacodyl|10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax
16331902|NCT00410215|Drug|picosalax|two sachets of picosalax taken orally the day prior to colonoscopy
16331903|NCT00410215|Drug|sodium phosphate|two 45 ml bottles of sodium phosphate the day prior to colonoscopy
16331904|NCT00410202|Drug|Entecavir|Tablets, Oral, 1mg, once daily, 100 weeks
16331905|NCT00410202|Drug|Tenofovir|Tablets, Oral, 300 mg, once daily
16331906|NCT00410202|Drug|Adefovir|Tablets, Oral, 10mg, once daily, 100 weeks
16331907|NCT00410202|Drug|Lamivudine|Tablets, Oral, 100mg, once daily, 100 weeks
16331908|NCT00410189|Drug|ZD6474|300 mg by mouth daily for 28 Days.
16331909|NCT00410176|Behavioral|sanitation and personal hygiene|
16331910|NCT00410163|Drug|Ofatumumab 500mg|Ofatumumab 500mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.
16331911|NCT00410163|Drug|Ofatumumab 1000mg|Ofatumumab 1000mg or should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 6½ hours.Infusions should be given every 4 weeks until a total of 6 infusions has been given.
16331912|NCT00410163|Drug|Fludarabine|Fludarabine (25 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses
16331913|NCT00410163|Drug|Cyclophosphamide|Cyclophosphamide (250 mg/m2) should be administered as an IV infusion daily, Days 2 through 4 of Course 1, and Days 1 through 3 of Courses 2 through 6, every 4 weeks for 6 courses.
16331914|NCT00410150|Drug|Helium-oxygen-driven albuterol nebulizer|Subjects will be treated with continuous albuterol nebs with Heliox
16331915|NCT00410150|Drug|Oxygen|Subjects will be treated with continuous albuterol nebs in oxygen
16331916|NCT00410124|Drug|RAD001|The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.
16331917|NCT00410124|Drug|Placebo|
16331918|NCT00410098|Behavioral|Bikram Yoga|
16331919|NCT00410085|Drug|L-NMMA (N-mono.methyl-L-arginine)|
16331920|NCT00410072|Drug|Entecavir|Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
16331921|NCT00410072|Drug|Entecavir + Tenofovir|Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
16331922|NCT00410059|Drug|Erlotinib|150 mg by mouth daily x 28 days
16331923|NCT00410046|Drug|Enbrel (etanercept)|Etanercept 50 mg SC injection once weekly
16331924|NCT00410033|Drug|soluble human insulin|
16331925|NCT00410033|Drug|isophane human insulin|
16331926|NCT00410033|Drug|insulin aspart|
16331927|NCT00410020|Behavioral|Alpha-linolenic enriched diet|
16331928|NCT00410007|Behavioral|High Sodium Diet|250-350 mmol
16331929|NCT00410007|Behavioral|Low Sodium Diet|25-35 mmol
16331930|NCT00410007|Behavioral|Hypertonic saline infusion|7 ml/ kg of 3% saline were given over 30 minutes.
16331931|NCT00409994|Drug|Rapamycin|dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
16331932|NCT00409981|Device|paclitaxel coated balloon catheter (device with drug)|
16331933|NCT00409968|Procedure|Tumor Biopsy|A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).
16331934|NCT00409955|Procedure|Lamellar transplant with lyophilized corneas|
16331935|NCT00409942|Drug|Torasemide Prolonged Release|Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
16331936|NCT00409942|Drug|Furosemide|Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
16331937|NCT00409929|Drug|AEB071|
16331938|NCT00409916|Device|BioZ Dx|
16331939|NCT00409903|Drug|Eprosartan|
16331940|NCT00409890|Drug|Hyoscine Butyl Bromide|
16331941|NCT00409864|Procedure|Endoscopic biliary stenting, Percutaneous biliary stenting|percutaneous 10 F stent, endoscopic 10 F stent insertion
16331942|NCT00409851|Drug|valsartan+amlodipine|
16331943|NCT00409838|Drug|Abatacept|Intravenous (IV) solution, - weight tiered (500 mg <60 kg); (750 mg 60-100 kg); (1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
16331944|NCT00409838|Drug|Methotrexate|Tablets, Oral, ≥ 15 mg, weekly, 6 months
16331945|NCT00409838|Drug|Placebo|IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
16331946|NCT00409838|Drug|Abatacept|Solution, intravenous, 10 mg/kg, every 28 days
16331947|NCT00409838|Drug|Methotrexate|Tablets, oral, 15 mg weekly to be adjusted according to patient condition
16331948|NCT00409825|Drug|17-OHPC|Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.
16332023|NCT00409253|Drug|URAPIDIL (EUPRESSYL*)|Urapidil (Eupressyl*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
16337224|NCT00370318|Drug|Paracetamol|
16331949|NCT00409825|Procedure|Blood Draws|10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.
16331950|NCT00409799|Drug|I-0401 (a new bone graft substitute)|1 time application
16331951|NCT00409786|Behavioral|Virtual Lifestyle Management (VLM)|16 weekly lessons followed by monthly maintenance lessons
16331952|NCT00409773|Drug|ezetimibe (+) simvastatin|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
16331953|NCT00409773|Drug|Comparator: atorvastatin calcium|"Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
~Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks."
16331954|NCT00409773|Drug|Comparator: Placebo (unspecified)|"Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
~ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
~Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks."
16331955|NCT00409760|Drug|valsartan+amlodipine combination, valsartan, amlodipine|
16331956|NCT00409747|Drug|Minocycline|
16331957|NCT00409734|Behavioral|Children with pyloric stenosis|Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
16331958|NCT00409734|Behavioral|Children without pyloric stenosis|Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
16331959|NCT00409721|Drug|Memantine|
16331960|NCT00409708|Drug|Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy|
16331961|NCT00409708|Behavioral|Behavior Therapy|
16331962|NCT00409695|Drug|Low Dose Thymoglobulin (ATG)|2.5 mg /kg by vein every other day for 3 doses (total dose = 7.5 mg/ kg).
16331963|NCT00409695|Drug|High Dose Thymoglobulin (ATG)|1.25mg/kg by vein every other day for 3 doses (total dose = 3.75mg/kg)
16331964|NCT00409682|Biological|Adalimumab|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
16331965|NCT00409682|Biological|Adalimumab|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
16331966|NCT00409682|Biological|Adalimumab|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
16331967|NCT00409669|Device|Barraquer tonometer|barraquer tonometer
16331968|NCT00409656|Drug|Basiliximab|
16331969|NCT00409643|Drug|valsartan+amlodipine combination|
16331970|NCT00409643|Drug|valsartan|
16331971|NCT00409643|Drug|amlodipine|
16331972|NCT00409630|Drug|fluticasone|
16331973|NCT00409617|Biological|adalimumab|Adalimumab 40 mg Every Other Week dosing
16331974|NCT00409617|Biological|adalimumab|Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.
16331975|NCT00409604|Device|Temporary RV VVI pacing|temporary pacing at the onset of revascularisation
16331976|NCT00409591|Drug|Maternal and infant nevirapine|"In women, one NVP 200 mg tablet at onset of labor;
~In neonates, NVP oral suspension 6 mg in the delivery room immediately"
16331977|NCT00409591|Drug|Maternal placebo and infant nevirapine|"In women, one placebo tablet at onset of labor;
~In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
~Comparison between Arms 1 and 2 is double-blinded."
16331978|NCT00409591|Drug|Maternal lopinavir+ritonavir|- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
16331979|NCT00409591|Drug|zidovudine|In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
16331980|NCT00409578|Drug|Placebo|Placebo tablets and capsules. In order to adequately blind the study, patients were required to take a total of 1 tablet and 2 capsules during the first 4 weeks of the study. During the remainder of the study, patients were required to take 2 tablets and 2 capsules. Each dose was taken by mouth with water at approximately 8:00 AM with or without food.
16331981|NCT00409578|Drug|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
16332024|NCT00409253|Drug|NICARDIPINE|Nicardipine : IV 6.25 mg bolus until PAD >105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days
16338653|NCT00358579|Drug|Vasopressin|40 IU
16331982|NCT00409578|Drug|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
16331983|NCT00409578|Drug|Aliskiren/valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.
16331984|NCT00409565|Drug|Cetuximab|"Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
~Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations"
16331985|NCT00409565|Drug|Bevacizumab|Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
16331986|NCT00409552|Behavioral|Virtual Reality based distraction|Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
16331987|NCT00409552|Behavioral|VR with flat projection display|VR with flat projection display
16331988|NCT00409552|Behavioral|non-interactive video with head display|non-interactive video with head display
16331989|NCT00409552|Behavioral|non-interactive video with with flat projection display|non-interactive video with with flat projection display
16331990|NCT00409539|Drug|Placebo|Placebo, 2 week duration.
16331991|NCT00409539|Drug|Placebo|Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
16331992|NCT00409539|Drug|SMP-986|Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
16331993|NCT00409526|Drug|Inhaled Iloprost|50 micrograms for one hour followed by 100 micrograms for one hour
16331994|NCT00409500|Drug|AQW051|
16331995|NCT00409487|Device|Continuous positive airway pressure (CPAP)|8 weeks of CPAP
16331996|NCT00409487|Drug|Valsartant treatment|8 weeks of Valsartant treatment (160 mg / day)
16331997|NCT00409461|Drug|ATG-Sirolimus-Tacrolimus|
16331998|NCT00409448|Behavioral|Counselor-assisted problem solving (CAPS)|In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.
16331999|NCT00409448|Behavioral|Internet-resource comparison (IRC)|Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.
16332000|NCT00409435|Drug|pyridostigmine|one 180 mg capsule per day for 3 days
16332001|NCT00409435|Drug|Placebo|one capsule per day for 3 days
16332002|NCT00409422|Behavioral|weight management program|
16332003|NCT00409409|Drug|300 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16332004|NCT00409409|Drug|Placebo tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16332005|NCT00409396|Procedure|Urinary PGEm level|Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
16332006|NCT00409396|Procedure|fecal calprotectin|Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
16332007|NCT00409383|Drug|Genasense® (oblimersen)|Cohorts 1 and 2: Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 7 days (Week 1) and beginning again on Day 22 and continuing for 7 days (Week 4); Cohort 3: Genasense 900 mg as a 1-hour intravenous infusion on Day 1, 4, 8, and 11 (Weeks 1 and 2) and Day 22, 25, 29, and 32 (Weeks 4 and 5).
16332008|NCT00409383|Drug|Abraxane® (paclitaxel protein-bound particles for injectable suspension)|Cohorts 1 and 2: Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense continuous infusion; Cohort 3: Abraxane 175 mg/m2 as a 30-minute intravenous infusion on Day 4 and Day 25 following end of Genasense 1-hour infusion
16332009|NCT00409383|Drug|Temodar® (temozolomide)|Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
16332010|NCT00409370|Device|SOMA safe enclosure|
16332011|NCT00409357|Drug|SL77.0499-10 (alfuzosin hydrochloride)|
16332012|NCT00409344|Drug|Dexmedetomidine|A continuous infusion of dexmedetomidine will be started at a dose of 0.8mcg/kg/hr. This will continue for no longer than 24 hours. Four hours post extubation the study drug wii be discontinued using a standard tapering protocol: 0.6mcg/kg/hr for 4 hours then 0.4mcg/kg/hr for 4 hours, then 0.2 mcg/kg/hr for 4 hours and then 0.1mcg/kg/hr for 4 hours and then turned off.
16332013|NCT00409344|Other|Normal Saline|Normal Saline will be given as the placebo and will administered at 0.8mcg/kg/hr
16332014|NCT00409331|Drug|Amifostine|500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
16332015|NCT00409331|Procedure|Intensity- Modulated Radiation Therapy|2.0 to 2.2 Gy delivered in 30 fractions
16332016|NCT00409318|Drug|Etanercept|50 mg SC q week
16332017|NCT00409318|Drug|Placebo|SC q week
16332018|NCT00409305|Drug|Betahistine|
16332019|NCT00409305|Behavioral|Dietary counseling|
16332020|NCT00409292|Drug|RAD001|Taken orally daily for as long as the participant continues to receive a benefit.
16332021|NCT00409279|Behavioral|Information, counseling and support|individual-family consultation, support group, and ad hoc consultation
16332022|NCT00409266|Device|Computer assisted navigation|
16332078|NCT00408772|Procedure|neoadjuvant therapy|
16332079|NCT00408772|Procedure|radiofrequency ablation|
16332025|NCT00409240|Other|MEDIC|Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
16332026|NCT00409227|Drug|Alpha blocker-alfuzosin|P.O. alfuzosin 10 mg once a day
16332027|NCT00409227|Drug|placebo|placebo once a day for 3 months or stone free
16332028|NCT00409214|Drug|LS11 (talaporfin sodium)|
16332029|NCT00409214|Device|Light source (interstitial light emitting diodes)|
16332030|NCT00409214|Procedure|Intraoperative placement of device in glioma|
16332031|NCT00409201|Drug|reboxetine adjuvant therapy|
16332032|NCT00409188|Biological|Tecemotide (L-BLP25)|After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.
16332033|NCT00409188|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.
16332034|NCT00409188|Drug|Placebo|A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.
16332035|NCT00409175|Drug|Fx-1006A|Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
16332036|NCT00409175|Drug|Placebo|Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
16332037|NCT00409162|Device|Eraser TM device, with washing fluid|
16332038|NCT00409149|Behavioral|CALM Approache|
16332039|NCT00409149|Behavioral|DASH approach|standard dietary DASH approach in hypertensive patients
16332040|NCT00409136|Behavioral|Human Alert|An alert from study staff informing a physician that his/her patient is at high risk for DVT and/or PE, but is not receiving any prophylaxis.
16332041|NCT00409097|Drug|Rosiglitazone|
16332042|NCT00409084|Procedure|endoscopic variceal band ligation|endoscopic variceal band ligation
16332043|NCT00409071|Drug|Cocculine®|12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
16332044|NCT00409071|Drug|placebo|12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
16332045|NCT00409058|Behavioral|Teen Online Problem Solving|We will test the following hypotheses: 1) Children with TBI receiving TOPS will have fewer behavior problems, greater social competence, and better functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 2) Caregivers of children receiving TOPS will report less depression and psychological distress, less parent-child conflict, and better family functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 3) Social resources will moderate treatment efficacy, such that children with limited social and economic resources will show greater improvements in the more comprehensive TOPS intervention. We hypothesize better teen problem solving and communication skills, fewer teen emotional/behavioral problems, less parental burden and distress, and less parent-teen conflict at follow-up among the TOPS group compared to the IRC group.
16332046|NCT00409032|Drug|Strontium malonate|
16332047|NCT00409019|Drug|Telbivudine|Study cancelled: Withdrawn before enrollment of any participants
16332048|NCT00409019|Drug|Adefovir|
16332049|NCT00409019|Drug|Tenofovir|
16332050|NCT00409006|Drug|Pemetrexed|500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
16332051|NCT00409006|Drug|Cisplatin|75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity
16332052|NCT00409006|Drug|Gefitinib|250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
16332053|NCT00408993|Drug|Duloxetine Hydrochloride|60 mg every day (QD) (morning or evening), by mouth (PO)
16332054|NCT00408993|Drug|Placebo|Placebo every day (QD), by mouth (PO)
16332055|NCT00408980|Behavioral|Fat and calorie controlled diet|
16332056|NCT00408967|Drug|Tucotuzumab celmoleukin (EMD 273066)|
16332057|NCT00408954|Drug|UK-369,003|100 mg MR tablet once daily for 2 weeks
16332058|NCT00408954|Drug|UK-369,003|UK-369,003-100 mg MR formulation for 2 weeks
16332059|NCT00408941|Drug|Propofol|
16332060|NCT00408941|Drug|Prilocaine|
16332061|NCT00408928|Drug|Bortezomib|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
16332062|NCT00408915|Drug|Continuous Subcutaneous Lisuride Infusion|
16332063|NCT00408902|Drug|tandutinib|Given orally, 500 mg bid daily
16332064|NCT00408902|Other|laboratory biomarker analysis|Correlative studies
16332065|NCT00408876|Drug|Duloxetine|
16332066|NCT00408876|Drug|Placebo|
16332067|NCT00408863|Drug|tibolone|tibolone 2.5 mg/day
16332068|NCT00408863|Drug|placebo|
16332069|NCT00408850|Drug|Pioglitazone|15 mg per day for 6 weeks and 30 mg per day for further 6 weeks
16332070|NCT00408850|Drug|sugar pill|One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks
16332071|NCT00408798|Drug|Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units|See Detailed Description.
16332072|NCT00408785|Drug|Botulinum Toxin Type A|botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
16332073|NCT00408785|Drug|sodium chloride|sodium chloride 0.9 mg
16332074|NCT00408772|Biological|bevacizumab|
16332075|NCT00408772|Drug|capecitabine|
16332076|NCT00408772|Drug|oxaliplatin|
16332077|NCT00408772|Procedure|conventional surgery|
16332081|NCT00408746|Behavioral|palatal development|Impressions of preterm and term palates.
16332082|NCT00408733|Other|Medication Education Tool|Picture and Icon-based Customizable Educational Tool
16332083|NCT00408707|Procedure|local infiltration analgesia|
16332084|NCT00408694|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16332085|NCT00408694|Biological|Bevacizumab|Given IV
16332086|NCT00408694|Drug|Cisplatin|Given IV
16332087|NCT00408694|Drug|Fluorouracil|Given IV
16332088|NCT00408694|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16332089|NCT00408681|Drug|lithium carbonate|Given orally
16332090|NCT00408681|Other|laboratory biomarker analysis|Correlative studies
16332091|NCT00408668|Biological|PEV3A|
16332092|NCT00408668|Biological|FP9 ME-TRAP|
16332093|NCT00408668|Biological|MVA ME-TRAP|
16332094|NCT00408655|Drug|paclitaxel|Given IV
16332095|NCT00408655|Drug|carboplatin|Given IV
16332096|NCT00408655|Drug|temsirolimus|Given IV
16332097|NCT00408642|Behavioral|Enhanced adherence support|The enhanced adherence support intervention consists of 5 one-on-one, Information-Motivation-Behavioral Skills (IMB) theory-based counseling sessions, as well as a problem-solving card which summarizes key messages and strategies. The counseling sessions are given at key points post-initiation of therapy: at baseline, 2 weeks, 2 months, 3 months, and 6 months. Three brief weekly ART planning sessions are conducted post-initiation of therapy.
16332098|NCT00408642|Behavioral|Standard adherence support|The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.
16332099|NCT00408629|Biological|adalimumab|Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.
16332100|NCT00408629|Biological|placebo|Matching Placebo for prefilled syringe, 40 mg,
16332101|NCT00408616|Biological|Grazax-R|Grass tablet, 75.000 SQ per day for one year
16332102|NCT00408616|Biological|Grazax Placebo|Grazax Placebo, 0 SQ tablet per day for one year
16332103|NCT00408603|Drug|Voreloxin Injection|All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
16332104|NCT00408590|Biological|carcinoembryonic antigen-expressing measles virus|
16332105|NCT00408590|Biological|oncolytic measles virus encoding thyroidal sodium iodide symporter|
16332106|NCT00408590|Genetic|reverse transcriptase-polymerase chain reaction|
16332107|NCT00408590|Other|laboratory biomarker analysis|
16332108|NCT00408577|Drug|L-arginine|
16332109|NCT00408564|Biological|cetuximab|
16332110|NCT00408564|Drug|capecitabine|
16332111|NCT00408564|Drug|oxaliplatin|
16332112|NCT00408564|Procedure|conventional surgery|
16332113|NCT00408564|Radiation|radiation therapy|
16332114|NCT00408564|Drug|Gemcitabine|
16332115|NCT00408551|Drug|floxuridine|Given IV
16332116|NCT00408551|Drug|fluorouracil|Given IV
16332117|NCT00408551|Drug|irinotecan hydrochloride|Given IV
16332118|NCT00408551|Drug|leucovorin calcium|Given IV
16332119|NCT00408551|Drug|oxaliplatin|Given IV
16332120|NCT00408538|Drug|UC-781 microbicide gel (0.1% and 0.25%)|
16332121|NCT00408538|Drug|placebo|
16332122|NCT00408525|Drug|donepezil|donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.
16332123|NCT00408512|Drug|thiazides|Up to 25 mg per day
16332124|NCT00408512|Procedure|Non thiazidic treatment|Amximum tolerated dosage as indicated from the label
16332125|NCT00408499|Drug|cetuximab|Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
16332126|NCT00408499|Drug|erlotinib|Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
16332127|NCT00408473|Drug|Flecainide|
16332128|NCT00408460|Drug|imatinib mesylate|Given PO
16332129|NCT00408460|Drug|paclitaxel|Given IV
16332130|NCT00408447|Drug|Busulfan|Busulfan 4 mg/kg/d x 4d
16332131|NCT00408447|Drug|Fludarabine|Fludarabine 30 mg/m2/d x 6d
16332132|NCT00408447|Drug|Alemtuzumab|Alemtuzumab 2mg/m2 x 1d, 6mg/m2 x 2 d, 20mg/m2 x 2d
16332133|NCT00408447|Procedure|Allogeneic stem cell transplant|Allogeneic stem cells will be given on day 0 (after chemotherapy conditioning)obtained either from a family donor (first degree relative) or sibling cord blood donor.
16332134|NCT00408434|Drug|CS-7017|CS-7017 0.05mg and 1.0mg tablets
16332135|NCT00408421|Drug|Duloxetine|
16332136|NCT00408421|Drug|placebo|
16332137|NCT00408408|Biological|bevacizumab|15 mg/kg IV
16332138|NCT00408408|Drug|capecitabine|825 mg/m2 orally
16332139|NCT00408408|Drug|cyclophosphamide|600 mg/m2 IV
16332140|NCT00408408|Drug|docetaxel|100 mg/m2 IV
16332141|NCT00408408|Drug|doxorubicin hydrochloride (Adriamycin)|60 mg/m2 IV
16332142|NCT00408408|Drug|gemcitabine hydrochloride|1000 mg/m2 IV
16332143|NCT00408395|Biological|Influenza vaccine|Seasonal Influenza Vaccine
16332144|NCT00408382|Drug|atorvastatin, Lipitor|
16332145|NCT00408369|Drug|DB289|
16332146|NCT00408356|Drug|Zinc|
16332147|NCT00408330|Drug|Azelaic Acid 15% Gel|15% gel, topically applied daily for six weeks
16332148|NCT00408330|Drug|Inactive 15% gel base|placebo, topically applied daily for six weeks
16332149|NCT00408317|Drug|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
16332224|NCT00407849|Drug|triamcinolone acetonide|Intravitreal injection
16332150|NCT00408317|Drug|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
16332151|NCT00408304|Drug|omega-3 fatty acid|
16332152|NCT00408291|Procedure|Winsta PH osteosynthesis device|The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
16332153|NCT00408278|Drug|ATRA|45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months
16332154|NCT00408278|Drug|Idarubicina|Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.
16332155|NCT00408278|Drug|Mitoxantrone|Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2
16332156|NCT00408278|Drug|ARA-C|In high risk patients, consolidation with ara-C in cycles 1 and 3.
16332157|NCT00408265|Behavioral|Contingency Management|
16332158|NCT00408252|Other|biopsies|No intervention, only biopsy for translational project
16332159|NCT00408252|Drug|SU011248|no intervention
16332160|NCT00408239|Drug|YM150|Oral
16332161|NCT00408239|Drug|enoxaparin|Sub cutaneous
16332162|NCT00408226|Drug|MKC-1|capsules, twice daily for 14 days in 21 day cycle
16332163|NCT00408226|Drug|pemetrexed|standard dosing of 500 mg/m2 infused every 21 days
16332164|NCT00408213|Drug|mycophenolate mofetil [CellCept]|1g po bid
16332165|NCT00408213|Drug|Placebo|po bid
16332166|NCT00408200|Drug|propafenone; flecainide; sotalol; dofetilide|Above drugs prescribed per established guidelines for treatment of AF
16332167|NCT00408200|Device|Radiofrequency catheter ablation|A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
16332168|NCT00408187|Drug|voclosporin|voclosporin 0.4 mg/kg po BID
16332169|NCT00408187|Drug|Ciclosporin|ciclosporin 1.5 mg/kg po BID
16332170|NCT00408187|Drug|Placebo|Placebo
16332171|NCT00408174|Drug|Balsalazide disodium|
16332172|NCT00408161|Behavioral|Contingency Management|prize contingency management (CM) -- 6-month treatment plus standard case management treatment and follow-ups at 9, 12, and 18 months after intake
16332173|NCT00408161|Behavioral|standard case management treatment|6-month treatment standard case management treatment, and follow-ups scheduled at 9, 12, and 18 months after intake.
16332174|NCT00408148|Drug|Placebo|Undistinguishable placebo tablets
16332175|NCT00408148|Drug|Rimonabant|White film-coated, for oral administration containing 20 mg of active rimonabant
16332176|NCT00408135|Drug|telithromycin (HMR3647)|
16332177|NCT00408122|Procedure|PET/CT scan and EUS|
16332178|NCT00408109|Drug|VRC-AVIDNA036-00-VP|
16332179|NCT00408096|Procedure|Copeland or Global CAP resurfacing prosthesis|Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
16332180|NCT00408083|Drug|MultiHance|0.5 mmol/kg as a single dose administration
16332181|NCT00408083|Drug|Magnevist|0.5 mmol/kg as a single dose administration
16332182|NCT00408070|Drug|Bevacizumab|cycle 2 (6 cycles re-evaluated and follow up)
16332183|NCT00408070|Drug|Carboplatin|cycle #1 and continuous through entire regimen; treated every 3 weeks
16332184|NCT00408070|Drug|Paclitaxel|cycle #1 and continuous through entire regimen; treated every 3 weeks
16332185|NCT00408057|Other|no intervention|no intervenion
16332186|NCT00408044|Procedure|cardiac surgery with sternotomy|
16332187|NCT00408031|Drug|D-cycloserine|D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated GLY site.
16332188|NCT00408018|Drug|P276-00|Potent Cyclin dependent kinase (cdk) cdk4 D1, cdk1 B and cdk9 T inhibitor
16332189|NCT00408005|Drug|Asparaginase|Given IM or IV
16332190|NCT00408005|Drug|Cyclophosphamide|Given IV
16332191|NCT00408005|Drug|Cytarabine|Given IT, IV, or SC
16332192|NCT00408005|Drug|Daunorubicin Hydrochloride|Given IV
16332193|NCT00408005|Drug|Dexamethasone|Given IV or PO
16332194|NCT00408005|Drug|Doxorubicin Hydrochloride|Given IV
16332195|NCT00408005|Other|Laboratory Biomarker Analysis|Correlative studies
16332196|NCT00408005|Drug|Leucovorin Calcium|Given PO
16332197|NCT00408005|Drug|Mercaptopurine|Given PO
16332198|NCT00408005|Drug|Methotrexate|Given IT or PO
16332199|NCT00408005|Drug|Nelarabine|Given IV
16332200|NCT00408005|Drug|Pegaspargase|Given IM or IV
16332201|NCT00408005|Drug|Prednisone|Given IV or PO
16332202|NCT00408005|Radiation|Radiation Therapy|Some patients undergo testicular and/or prophylactic cranial RT
16332203|NCT00408005|Drug|Thioguanine|Given PO
16332204|NCT00408005|Drug|Vincristine Sulfate|Given IV
16332205|NCT00407992|Device|Occipital nerve stimulation ON|Implant of an occipital nerve stimulator switched ON
16332206|NCT00407992|Device|Occipital nerve stimulation off|Implant of an occipital nerve stimulator switched OFF
16332207|NCT00407966|Drug|alvocidib|Given IV
16332208|NCT00407966|Drug|cytarabine|Given IV
16332209|NCT00407966|Drug|mitoxantrone hydrochloride|Given IV
16332210|NCT00407940|Device|Lower extremity Atherectomy and Cryoplasty|
16332211|NCT00407927|Drug|Epinastine Nasal Spray|
16332212|NCT00407914|Device|Aquamid|Subcutaneous injection
16332213|NCT00407914|Device|Restylane|Injection in dermis
16332214|NCT00407888|Drug|doxorubicin hydrochloride|Given IV
16332215|NCT00407888|Drug|cyclophosphamide|Given orally
16332216|NCT00407888|Biological|filgrastim|Given SC
16332217|NCT00407888|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16332218|NCT00407888|Biological|trastuzumab|Given IV
16332219|NCT00407888|Other|laboratory biomarker analysis|Correlative studies
16332220|NCT00407888|Procedure|quality-of-life assessment|Ancillary studies
16332221|NCT00407875|Procedure|Intensity Modulated External Beam Radiation Therapy|
16332222|NCT00407862|Drug|Telmisartan 80 mg|
16332225|NCT00407836|Biological|T cell vaccination|Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.
16332226|NCT00407836|Biological|T cell vaccination|Approximately 10-20 million autologous CD4 reactive T cells per each vaccine injection
16332227|NCT00407823|Procedure|Central venous oxygen saturation continuous monitoring|
16332228|NCT00407797|Drug|Pregabalin|150 to 600 mg/day during 21 weeks
16332229|NCT00407784|Drug|eplerenone|
16332230|NCT00407771|Drug|Tirofiban|
16332231|NCT00407758|Drug|enzastaurin hydrochloride|
16332232|NCT00407745|Drug|placebo|Placebo
16332233|NCT00407745|Drug|pregabalin|Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
16332234|NCT00407732|Behavioral|psychosocial intervention|motivational enhancing case management intervention
16332235|NCT00407719|Drug|Bevacizumab|
16332236|NCT00407706|Procedure|blood test|
16332237|NCT00407693|Drug|[C-11]PRB28|
16332238|NCT00407680|Drug|Intensive therapy Valsartan,Fluvastatin|
16332239|NCT00407667|Device|transcranial galvanic stimulation|for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
16332240|NCT00407654|Drug|aflibercept|Given intravenously
16332241|NCT00407641|Drug|Tinzaparin administration|Patients will receive tinzaparin during the HD session
16332242|NCT00407641|Drug|Heparin administration|Patients will receive Heparin as an anticoagulant during the HD session.
16332243|NCT00407615|Device|Flex Pad/Static Magnet|
16332244|NCT00407602|Device|Argus II Retinal Stimulation System|epiretinal implantation of device
16332245|NCT00407589|Drug|BOL-303224-A|1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
16332246|NCT00407576|Drug|[11C]MeS-IMPY|
16332247|NCT00407563|Drug|Bevacizumab|Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
16332248|NCT00407563|Drug|Abraxane|Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
16332249|NCT00407550|Drug|gemcitabine HCL|1250 mg/m^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 & 8 of each cycle (21 days) x6 cycles.
16332250|NCT00407550|Drug|pemetrexed disodium|500 mg/m^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle.
16332251|NCT00407550|Drug|gemcitabine HCL|1500 mg/m^2 administered through 250 cc NS IV infusion over 30 minutes at days 1 of each cycle (14 days) x9 cycles.
16332252|NCT00407537|Drug|Amlodipine besylate/atorvastatin calcium single pill combination|Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
16332253|NCT00407524|Drug|AKL 1|
16332254|NCT00407511|Drug|Pregabalin|Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).
16332255|NCT00407498|Drug|P276-00|Starting dose of 9 mg/m2/day from day 1to 5 and day 8 to 12 in 21 day cycle.Protocol wa amended to dose the subjects for day 1 to5 in 21 day cycle after 34.4 mg/m2/day cohort.Maximum dose administered was 259 mg/m2/day
16332256|NCT00407485|Biological|ziv-aflibercept|Given IV
16332257|NCT00407485|Other|pharmacological study|Correlative studies
16332258|NCT00407472|Device|ATS-1 needle free device|
16332259|NCT00407459|Drug|Bevacizumab, Pemetrexed, Carboplatin|"Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks
~Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks
~Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks"
16332260|NCT00407446|Drug|sildenafil|
16332261|NCT00407433|Drug|Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)|
16332262|NCT00407420|Device|Mandometer|A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.
16332263|NCT00407420|Behavioral|Lifestyle|Typical dietary and activity advice as normally provided in clinic (control).
16332264|NCT00407407|Drug|ABI-007|80mg/m^2 to 150mg/m^2 IV every 3 weeks
16332265|NCT00407407|Drug|Carboplatin|6 AUC IV every 3 weeks on the same day as ABI-007
16332266|NCT00407394|Drug|Amoxycillin|
16332267|NCT00407381|Drug|Ranibizumab|Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.
16332268|NCT00407381|Procedure|Laser photocoagulation|Laser photocoagulation in either focal or grid pattern as determined by investigator.
16332269|NCT00407368|Procedure|Blood Sample|
16332270|NCT00407355|Drug|Intravitreal injection of ranibizumab .3 dose|PRN every 30 days withing retreatment criteria
16332271|NCT00407355|Drug|Intravitreal injection of Ranibizumab .5 dose|Intravitreal injection of Ranibizumab .5 dose every 30 days PRN with retreatment criteria
16332272|NCT00407342|Drug|Alefacept (drug)|alefaceptgiven iv
16332273|NCT00407342|Procedure|Narrowband UVB phototherapy|
16332274|NCT00407329|Procedure|transurethral resection of the prostate|resection of prostate
16332275|NCT00407303|Drug|Obatoclax mesylate|30 mg, 45 mg
16332276|NCT00407303|Drug|Bortezomib|1.0mg/m2, 1.3 mg/m2
16332277|NCT00407290|Drug|neostigmine|
16332278|NCT00407277|Drug|Nicotine patch|21 mg of nicotine via a dermal patch
16332279|NCT00407277|Other|placebo|placebo via a dermal patch
16332280|NCT00407277|Behavioral|smoking cessation group therapy|"a 9-week group based on the Freedom From Smoking program designed by the American Lung Association. The treatment was manualized and modified to meet the functional and cognitive capabilities of patients with psychotic disorders"
16332281|NCT00407264|Drug|Fluticasone propionate|
16332282|NCT00407251|Drug|Patupilone|
16332283|NCT00407238|Device|Multi-purpose solutions (polyquaternium-1 and PHMB)|
16332284|NCT00407225|Drug|Difluprednate Ophthalmic Emulsion|
16332285|NCT00407212|Drug|TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)|
16332286|NCT00407199|Drug|quetiapine|
16332382|NCT00406458|Drug|SB-509|60 mg dose
16332287|NCT00407186|Drug|cisplatin+capecitabine|cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.
16332288|NCT00407186|Radiation|radiotherapy|45 Gy in 25 fracions (5 days/week)
16332289|NCT00407186|Drug|epirubicin+cisplatin+capecitabine|3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)
16332290|NCT00407173|Drug|HCV-796|HCV-796 1000mg single dose
16332291|NCT00407147|Device|Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor|"antibiotic treatment based on clinical decision making with traditional thought processes used in both groups. In addition the physician will be given access to Procalcitonin values with recommended thresholds for likelihood of infection."
16332292|NCT00407134|Procedure|Different abdominal volumes and different glucose-concentrations during peritoneal dialysis|
16332293|NCT00407121|Drug|Bevacizumab|
16332294|NCT00407121|Procedure|Intravitreal Injection of Bevacizumab|
16332295|NCT00407108|Procedure|Vitrectomy|
16332296|NCT00407095|Drug|Pardoprunox|12-42 mg/day
16332297|NCT00407082|Drug|fluocinolone acetonide intravitreal implant|Fluocinolone acetonide ocular implant 0.59mg
16332298|NCT00407082|Drug|Fluocinolone acetonide 2.1mg|Fluocinolone acetonide ocular implant 2.1mg
16332299|NCT00407056|Drug|Difluprednate Ophthalmic Emulsion|
16332300|NCT00407043|Drug|Lotemax|
16332301|NCT00407043|Drug|Restasis|
16332302|NCT00407030|Drug|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (240 Units)"
16332303|NCT00407030|Drug|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (120 Units)"
16332304|NCT00407030|Drug|Placebo|Placebo
16332305|NCT00407017|Drug|Gatifloxacin|
16332306|NCT00407017|Drug|Ketorolac LS|
16332307|NCT00407017|Drug|Pred Forte|
16332308|NCT00407017|Drug|Moxifloxacin|
16332309|NCT00407017|Drug|Nepafenac|
16332310|NCT00407017|Drug|EconoPred Plus|
16332311|NCT00407004|Device|MARS (Molecular Adsorbents Recirculating System)|
16332312|NCT00407004|Device|Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)|
16332313|NCT00406991|Drug|aspirin|
16332314|NCT00406991|Drug|clopidogrel|
16332315|NCT00406978|Drug|Prednisone|Prednisone will be given orally at the dose of 1.5 mg/Kg for 4 days followed by a 31-day rest period (days 5 through 35)
16332316|NCT00406978|Drug|Melphalan|Melphalan will be given orally at the dose of 0.25 mg/Kg for 4 days,
16332317|NCT00406978|Drug|Thalidomide|Thalidomide will be administered orally at the initial dose of 50 mg/day p.o. once daily, with increment of 50 mg after a month to acceptable tolerance (maximum 100 mg), continuously for the entire 6 courses.
16332318|NCT00406978|Drug|Defibrotide|Lev - 1 Def = 10 mg/Kg (max 0.6 g) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Lev - 1 Def = 1.2 g p.o (400 mg every 8 hours) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Level + 1 Def = 17 mg/Kg (max 1.2 g) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 1 Def = 2.4 g p.o. (400 mg every 4 hours) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 2 Def = 34 mg/Kg (max 2.4 g) as a i.v. injection on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 2 Def = 4.8 g p.o. (800 mg every 4 hours) on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 3 Def = 51mg/Kg (max 3.6 g) as a i.v. injection on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) through day 35 Lev + 3 Def = 7.2 g p.o.(1200 mg every 4 hours ) on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) given p.o. through day 35
16332319|NCT00406965|Drug|HAE1 (PRO98498)|
16332320|NCT00406952|Procedure|electronic diary|
16332321|NCT00406952|Drug|Sertraline|
16332322|NCT00406952|Drug|Placebo|
16332323|NCT00406952|Procedure|voice acoustics|
16332324|NCT00406939|Genetic|IL-12 gene|
16332325|NCT00406926|Drug|Somatropin|
16332326|NCT00406913|Drug|mupirocin ointment|
16332327|NCT00406913|Other|SOC sterilization|
16332328|NCT00406900|Procedure|Treatment of metastatic disease|
16332329|NCT00406887|Drug|Difluprednate Ophthalmic Emulsion|
16332330|NCT00406874|Drug|omega 3 fats|1,000 mg daily
16332331|NCT00406874|Drug|folic acid|800 micrograms daily
16332332|NCT00406861|Drug|montelukast in treatment of ENL reaction|
16332333|NCT00406848|Drug|duloxetine hydrochloride|Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
16332334|NCT00406848|Drug|placebo|Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
16332335|NCT00406835|Procedure|Whole-Brain Radiation Therapy, Stereotactic Radiosurgery|
16332336|NCT00406822|Device|OculusGen Biodegradable Collagen Matrix Implant|
16332337|NCT00406809|Drug|ABT-263|"Oral solution
~Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing.
~Oral solution and tablets
~Phase 2a dosing under 21 day continuous dosing.
~- 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose."
16332338|NCT00406796|Drug|Ranibizumab|0.3mg and 0.5mg dose of Ranibizumab 0.05ml administered intravitreally
16332339|NCT00406783|Drug|5-mg Desloratadine|5-mg Desloratadine tablet, once daily for 15 days
16332340|NCT00406783|Drug|Placebo|Placebo tablet, once daily for 15 days
16332341|NCT00406770|Device|Light therapy|
16332342|NCT00406757|Drug|Nelarabine injection 400mg/m2|"Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5.
~Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5."
16332343|NCT00406757|Drug|Nelarabine injection 650mg/m2|Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.
16332344|NCT00406757|Drug|Nelarabine injection 1000mg/m2|"Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5.
~Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5."
16332345|NCT00406757|Drug|Nelarabine injection 1500mg/m2|Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
16332346|NCT00406744|Drug|Intravitreal injection of Bevacizumab|
16332347|NCT00406731|Drug|NG-monomethyl-L-arginine (L-NMMA)|bolus 6 mg/kg over 5 minutes followed by a continuous intravenous infusion of 60 µg/kg/min over 12 minutes; twice on 1 study day
16332348|NCT00406731|Drug|Endothelin-1 (ET-1)|5 ng/kg/min intravenous infusion over 17 minutes; twice on 1 study day
16332349|NCT00406731|Drug|Physiologic saline solution (placebo control)|intravenous infusion over 20 minutes; twice on 1 study day
16332350|NCT00406731|Device|Laser Doppler flowmetry|blood flow measurements at the temporal neuroretinal rim of the optic nerve head
16332351|NCT00406731|Device|Goldmann applanation tonometer|Intraocular pressure measurements
16332352|NCT00406731|Device|HP-CMS patient monitor|blood pressure and pulse rate measurements
16332353|NCT00406731|Procedure|Suction cup method|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
16332354|NCT00406718|Behavioral|Med-eMonitor|Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.
16332355|NCT00406718|Behavioral|PharmCAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
16332356|NCT00406718|Behavioral|Treatment as Usual|Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
16332357|NCT00406705|Behavioral|Helium-Hyperoxia|
16332358|NCT00406692|Drug|Zonisamide|Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.
16332359|NCT00406679|Drug|Paracetamol (acetaminophen) solution experimental|1 gm IV
16332360|NCT00406679|Drug|paracetamol (acetaminophen) solution commercial|1 gm IV
16332361|NCT00406679|Drug|placebo|equivalent volume IV 0.9% sodium chloride (equivalent volume)
16332362|NCT00406653|Drug|abatacept|"Dextrose 5% in water, intravenous (IV).
~Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
~3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
~~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
~or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57.
~Induction Period 3 months
~Maintenance Period 12 months"
16332363|NCT00406653|Drug|placebo|"Normal saline, IV, 0 mg/kg, every 28 days.
~Induction Period 3 months
~Maintenance Period 12 months"
16332364|NCT00406653|Drug|abatacept|"~10 mg/kg, every 28 days.
~Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued"
16332365|NCT00406640|Drug|Desvenlafaxine succinate sustained-release (DVS SR)|flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
16332366|NCT00406640|Drug|Escitalopram|Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
16332367|NCT00406614|Behavioral|Health Literacy-Focused High Blood Pressure Intervention|Participants assigned to the intervention group will attend a weekly 2-hour educational session for 6 weeks that will cover topics such as learning medical terminology, understanding the content of prescription and appointment slips, and blood pressure (BP) management strategies. Upon completion of the educational sessions, participants will submit BP measurements via telephone monitoring system for 12 months and Community Health Worker (CHW) will conduct telephone counseling once every month during the same 12-month period for support and follow-up counseling. Participants will continue to monitor BP measurement by logging BP data on BP diary book for another 12 months. Control group participants will receive the same intervention education following the completion of the study.
16332368|NCT00406601|Drug|Sorafenib (BAY-43-9006)|800 mg/die orally on a continuous basis
16332369|NCT00406588|Drug|Levodopa (Pardoprunox)|12-42mg
16332370|NCT00406588|Drug|Placebo Comparator|Placebo
16332371|NCT00406575|Drug|Placebo|Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
16332372|NCT00406575|Drug|Recombinant human relaxin (rhRlx)|Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
16332373|NCT00406562|Biological|Boostrix|
16332374|NCT00406536|Dietary Supplement|Lym-X-Sorb powder|Lym-X-Sorb is an organized matrix of lyso phosphatidylcholine (LPC), free fatty acid (FFA) and monoglyceride formulated at 20wt% with flour and sugar. A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.
16332375|NCT00406536|Dietary Supplement|Placebo powder|The placebo is composed of soybean oil, sunflower oil, fully hydrogenated cottonseed oil and flax seed oil dispersed at 16wt% on flour and sugar. The placebo is >99% triglycerides with no trans fatty acids. The fatty acid composition and caloric content is designed to match the active supplement (Lym-X-Sorb). A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.
16332376|NCT00406523|Device|JANUS Stent|
16332377|NCT00406510|Drug|Optive, Systane|
16332378|NCT00406497|Drug|Difluprednate Ophthalmic Emulsion|
16332379|NCT00406484|Behavioral|Standard drug counseling|Individual drug counseling
16332380|NCT00406484|Behavioral|BDRC|Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions
16332381|NCT00406471|Drug|Ranibizumab (Lucentis)|500 microgram intravitreal injection for 8 months or 300 microgram intravitreal injection for 8 months
16332384|NCT00406432|Drug|Paroxetine Controlled Release Tablet|Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.
16332385|NCT00406419|Drug|Methotrexate|Methotrexate tablet was administered orally at a dose 7.5-25 mg
16332386|NCT00406419|Drug|ocrelizumab|Ocrelizumab was administered via IV infusion at a dose specified in arm description
16332387|NCT00406419|Drug|Placebo|Matching placebo to ocrelizumab was administered via IV infusion
16332388|NCT00406406|Drug|SKI-606|
16332389|NCT00406393|Drug|Tacrolimus|"Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible.
~The target serum level for tacrolimus is 5-10 ng/mL."
16332390|NCT00406393|Drug|Methotrexate|Methotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation.
16332391|NCT00406393|Drug|Sirolimus|"Adults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose.
~Children: Children aged < 12.0 years OR weighing < 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram.
~The target serum level for sirolimus is 3-12 ng/mL."
16332392|NCT00406380|Drug|Bevacizumab|
16332393|NCT00406380|Procedure|Intravitreal injection of Bevacizumab|
16332394|NCT00406367|Drug|incobotulinumtoxinA (Xeomin)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection"
16332395|NCT00406367|Drug|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
16332396|NCT00406354|Drug|Atomoxetine|Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
16332397|NCT00406354|Drug|Placebo|Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
16332398|NCT00406341|Drug|Difluprednate Ophthalmic Emulsion|
16332399|NCT00406315|Drug|ziprasidone|Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
16332400|NCT00406302|Drug|Docetaxel|75mg/m², day 1,22
16332401|NCT00406302|Drug|oxaliplatin|40mg/m², d1,2,22,23
16332402|NCT00406302|Drug|cetuximab|400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)
16332403|NCT00406302|Procedure|surgery|28 days after end of induction chemotherapy
16332404|NCT00406289|Procedure|18F-FDG-PET radiotherapy|
16332405|NCT00406276|Drug|RAD001|RAD001 will be given at a dose of 5mg/day in combination with docetaxel
16332406|NCT00406276|Drug|Docetaxel|In combination with RAD001
16332407|NCT00406263|Procedure|Scheimpflug crystalline lens photographs|scheimpflug photographs
16332408|NCT00406250|Drug|intravitreal injection|1.25 mg in 0.05 cc of bevacizumab
16332409|NCT00406250|Drug|intravitreal injection|1.25 mg of bevacizumab intravitreally injected in a steril field
16332410|NCT00406237|Drug|tigecycline|Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion
16332411|NCT00406224|Drug|breathing 100% oxygen|
16332412|NCT00406211|Biological|MMRV|
16332413|NCT00406211|Biological|MMR (Priorix®)|
16332414|NCT00406211|Biological|Varicella (Varilrix®)|
16332415|NCT00406198|Procedure|venovenous hemofiltration|
16332416|NCT00406172|Drug|Bevacizumab|
16332417|NCT00406159|Device|Hyperbaric Oxygen Therapy|
16332418|NCT00406146|Drug|amodiaquine+artesunate/artemether-lumefantrine|
16332419|NCT00406133|Device|Continuous glucose monitor|Daily use of a continuous glucose monitor
16332420|NCT00406120|Procedure|Fine needle aspiration biopsy|
16332421|NCT00406107|Drug|pegaptanib sodium (Macugen)|Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48.
16332422|NCT00406094|Drug|montelukast|10mg
16332423|NCT00406094|Drug|placebo|placebo
16332424|NCT00406068|Drug|Mycobacterial cell wall-DNA complex|8 mg MCC, intravesical - Induction Phase (6 weekly intravesical instillations) and Maintenance Phase (3 weekly instillations at months 3, 6, 12, 18 and 24).
16332425|NCT00406055|Device|RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6|Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.
16332426|NCT00406042|Drug|prednisolone acetate 1%|
16332427|NCT00406029|Drug|Preladenant|1 mg BID capsules
16332428|NCT00406029|Drug|Preladenant|2 mg BID capsules
16332429|NCT00406029|Drug|Preladenant|5 mg BID capsules
16332430|NCT00406029|Drug|Preladenant|10 mg BID capsules
16332431|NCT00406029|Drug|Placebo|BID capsules
16332432|NCT00406029|Drug|L-dopa|Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).
16332433|NCT00406029|Drug|Other Parkinson's Disease treatments|Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.
16332434|NCT00406016|Drug|ATI355|
16332435|NCT00406003|Drug|Paroxetine controlled release tablet|Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.
16332436|NCT00405990|Behavioral|Voluntary counselling and HIV testing in ANC for PMTCT|VCT for 30 minutes in ANC
16332437|NCT00405990|Behavioral|VCT|HIV VCT for PMTCT
16332438|NCT00405977|Drug|Physiologic saline|Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group and 1 ml per kg physiological saline. The infusion will be given with during 15 minutes.
16332439|NCT00405977|Drug|Magnesium sulphate|Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given during 15 minutes.
16332440|NCT00405964|Drug|5-mg Desloratadine|5-mg Desloratadine tablet, once daily for 12 weeks
16332441|NCT00405964|Drug|Placebo tablet|Placebo tablet, once daily for 12 weeks
16332442|NCT00405951|Drug|Obatoclax mesylate 250 ml|
16332443|NCT00405951|Drug|Docetaxel|
16332444|NCT00405938|Drug|Bevacizumab|Bevacizumab 10mg/kg IV every 2 weeks
16332445|NCT00405938|Drug|Anastrozole|anastrozole (1 mg orally daily)
16332446|NCT00405938|Drug|Fulvestrant|fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).
16332447|NCT00405925|Drug|Trizivir|
16332448|NCT00405925|Drug|zidovudine,lamivudine,abacavir|zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
16332449|NCT00405912|Drug|Placebo|Placebo (inactive drug) given 3 times per day
16332450|NCT00405912|Drug|St. John's Wort-900 mg/day|St. John's Wort - 300 mg tables -3 times per day
16332451|NCT00405912|Drug|St. John's Wort-1800mg/day|St. John's Wort - 600 mg tables - 3 times per day
16332452|NCT00405886|Drug|Neramexane|Oral tablets, duration: 16 weeks
16332453|NCT00405886|Drug|Placebo|Oral tablets, duration: 16 weeks
16332454|NCT00405873|Drug|AMT2003|
16332455|NCT00405860|Drug|CellCept (mycophenolate mofetil)|
16332456|NCT00405847|Drug|Dexmedetomidine|
16332457|NCT00405834|Device|Envision® Patient Support System|
16332458|NCT00405821|Drug|Acyclovir|400mg twice daily for 24 months
16332459|NCT00405821|Drug|Placebo|Placebo tablet twice daily for 24 months
16332460|NCT00405808|Drug|Rimonabant|Once daily in the morning
16332461|NCT00405808|Drug|Placebo|Once daily in the morning
16332462|NCT00405795|Device|Envision® Patient Support System|
16332463|NCT00405782|Behavioral|Moderate-Intensity Exercise|Exercise program designed by exercise physiologist
16332464|NCT00405769|Drug|red yeast rice|600 mg 3 caps bid
16332465|NCT00405769|Drug|placebo|3 caps bid
16332466|NCT00405756|Drug|Lenalidomide: Double-blind Induction|Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
16332467|NCT00405756|Drug|Melphalan|Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
16332468|NCT00405756|Drug|Prednisone|Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
16332469|NCT00405756|Drug|Aspirin|"Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.
~Double-blind maintenance: at the investigator's discretion"
16332470|NCT00405756|Drug|Placebo|"Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.
~Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression."
16332471|NCT00405756|Drug|Lenalidomide: Double-blind Maintenance|Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.
16332472|NCT00405756|Drug|Lenalidomide: Open-label|Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.
16332473|NCT00405743|Drug|CP-4055|CP-4055 Continuous IV infusion
16332474|NCT00405743|Drug|CP-4055|CP4055 2 and 4 hour IV infusion
16332475|NCT00405730|Drug|Nepafenac 1mg/ml eye drops, suspension|One drop in the study eye 3 times daily for 23 days
16332476|NCT00405730|Drug|Ketorolac Trometamol 5 mg/ml eye drops, solution|One drop in the study eye 3 times daily for 23 days
16332477|NCT00405730|Other|Nepafenac vehicle eye drops|One drop in the study eye 3 times daily for 23 days
16332478|NCT00405717|Drug|atorvastatin,pravastatin|
16332479|NCT00405704|Drug|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
16332480|NCT00405704|Drug|Placebo|Cherry flavored liquid suspension matched to active comparator.
16332481|NCT00405691|Device|"TOPS System - Total Posterior Arthroplasty Implant"|
16332482|NCT00405678|Behavioral|Exercise Training|Subjects receiving chemo with exercise training
16332483|NCT00405678|Behavioral|Chemo only|Subjects receiving chemo only
16332484|NCT00405665|Drug|L-arginine|Group 1 will receive the active treatment followed by the inactive treatment. The active treatment phase will consist of L-arginine 250 mg/ml dispensed in 2.2 ml vials, from which the patient will take 2ml (500mg) and dilute with 3ml of sterile water to give 5ml of a 100mg/ml solution. Dosing in the inactive treatment phase will consist of a placebo of similar osmolarity and appearance will be formulated and dosed in a similar fashion. It will consist of 2.2ml vials of 1110mmol/L hypertonic saline. Again, the patient will take 2ml and dilute with 3ml of sterile water to give a 445mmol/L solution which has similar tonicity (10%) to the L-arginine. Both treatment phases will be administered by inhalation with a PARI eFLOW device.
16332485|NCT00405665|Drug|L-arginine|Group 2 will receive the inactive treatment followed by the active treatment.
16332486|NCT00405652|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|experimental
16332533|NCT00405262|Drug|Ketorolac|0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
16332591|NCT00404742|Drug|LX211|0.4 mg/kg, twice a day (BID)
16332487|NCT00405639|Drug|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
16332488|NCT00405639|Drug|Placebo|Normal saline will be used for placebo.
16332489|NCT00405626|Drug|Bellis Perenis ,Arnica montana|
16332490|NCT00405613|Drug|Aspirin|
16332491|NCT00405600|Procedure|Device used in surgery with or without instrumentation|Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
16332492|NCT00405587|Drug|PLX4032|Oral capsules administered BID
16332493|NCT00405574|Drug|ATN-224|ATN-224 high dose: 300mg ATN-224 low dose: 30mg
16332494|NCT00405561|Drug|AMT2003|
16332495|NCT00405548|Drug|BNP (nesiritide)|
16332496|NCT00405548|Drug|Placebo|
16332497|NCT00405535|Drug|glycine|
16332498|NCT00405535|Other|placebo|
16332499|NCT00405522|Drug|Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg|Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
16332500|NCT00405522|Drug|Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg|Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
16332501|NCT00405496|Drug|Difluprednate Ophthalmic Emulsion|
16332502|NCT00405483|Procedure|Standard exposure|Minimal invasive vs standard exposure of the joint is the difference between a small incision, smaller equipment for less tissue damage vs large incision (standard is greater than 10cm)and subsequent more tissue damage.
16332503|NCT00405483|Procedure|Minimally Invasive|Minimally invasive surgical technique (minimal incision)
16332504|NCT00405470|Device|Advance Medial Pivot Knee Arthroplasty|medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post. Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post
16332505|NCT00405457|Drug|Restasis, Optive Tears|Restasis and Optive Tears use twice daily more frequently if needed
16332506|NCT00405444|Drug|Fentanyl|The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
16332507|NCT00405444|Drug|Sterile water|The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
16332508|NCT00405431|Drug|Restasis|1 drop in study eye twice a day X 6 months
16332509|NCT00405431|Drug|Endura (artificial tears)|1 drop in study eye twice a day X 6 months
16332510|NCT00405418|Drug|Insulin glargine|Subcutaneous injection, once a day in the evening
16332511|NCT00405418|Drug|Insulin Detemir|Subcutaneous injection, twice a day at breakfast and before dinner
16332512|NCT00405405|Drug|Cisplatin|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
16332513|NCT00405405|Drug|Docetaxel|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
16332514|NCT00405405|Drug|Bevacizumab|"Two cycles during neoadjuvant therapy
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
16332515|NCT00405405|Drug|Erlotinib|"Two cycles during neoadjuvant therapy (dose escalation)
~Response assessment at approximately day 36
~Concurrent biochemoradiotherapy"
16332516|NCT00405405|Radiation|Radiotherapy|Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
16332517|NCT00405392|Drug|Ibandronate (SB743830HD)|
16332518|NCT00405379|Device|Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty|new porous metal tibial component with potential to result in improved bone in-growth and implant integration with proximal tibia
16332519|NCT00405366|Drug|sorafenib tosylate|Patients will receive treatment with 400mg of sorafenib, orally, twice daily, on a continuous basis as a single agent for at least 4 weeks, but not more than 8 weeks prior to their scheduled nephrectomy
16332520|NCT00405353|Drug|Androgel 10 grams of gel containing 100 mg of testosterone|testosterone gel
16332521|NCT00405340|Drug|Rituximab|Patients will received rituximab 4 weekly doses of rituximab 375 mg/m2 at baseline. Patients will be retreated at 6 months.
16332522|NCT00405327|Biological|Tumor lysate-pulsed dendritic cell (DC) vaccine|Tumor lysate-pulsed dendritic cell vaccine
16332523|NCT00405327|Other|Hematopoietic stem cell transplantation (HSCT)|Hematopoietic stem cell transplantation (HSCT)
16332524|NCT00405314|Device|Continuous positive airway pressure ventilation mask|
16332525|NCT00405301|Drug|Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day)|Patients who develop ATT drug induced hepatotoxicity will be divided into 3 arms .Arm 1,2,3 will be given drugs as described in detailed description of the title.
16332526|NCT00405288|Drug|Proctofoam-HC®|Observational study of the exposure to Proctofoam-HC®
16332527|NCT00405275|Drug|Etanercept|etanercept, subcutaneous injection
16332528|NCT00405275|Drug|methotrexate|baseline methotrexate is maintained throughout the study and is not provided by the sponsor
16332529|NCT00405275|Drug|Sulfasalazine|sulfasalazine, oral
16332530|NCT00405275|Drug|Hydroxychloroquine|hydroxychloroquine, oral
16332531|NCT00405275|Drug|Placebo, triple|Participants in Etanercept arm (Arm 1) were given placebo hydroxychloroquine and sulfasalazine pills.
16332532|NCT00405275|Drug|Placebo, etanercept|Participants in triple arm (Arm 2) were given placebo etanercept injections.
16338710|NCT00358124|Drug|metformin|
16332534|NCT00405262|Drug|Bupivacaine|0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
16332535|NCT00405262|Drug|ketorolac + bupivacaine|"0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
~For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter"
16332536|NCT00405249|Drug|elvucitabine|
16332537|NCT00405236|Drug|tiotropium|
16332538|NCT00405210|Drug|sorafenib (200 or 400mg bid) and taxotere iv|200 mg BID, day 3-19 cycle 1, day 2-19 other cycles 200 mg BID, day 3-21 Cycle 1, day 1-21 other cycles 400 mg BID, day 3-19 cycle 1, day 2-19 other cycles 400 mg BID, day 3-21 cycle 1, day 1-21 other cycles
16332539|NCT00405197|Behavioral|Isocaloric diet high in MUFA or Mediterranean diet|
16332540|NCT00405184|Drug|IntragamP|IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously.
16332541|NCT00405184|Drug|Ig NextGen 10%|Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously.
16332542|NCT00405171|Drug|Nevirapine|
16332543|NCT00405158|Procedure|Acupuncture treatment|
16332544|NCT00405158|Procedure|Administration of oxytocin nasal spray|
16332545|NCT00405158|Procedure|Improved breast milk removal|
16332546|NCT00405158|Procedure|Warmth applied to breasts|
16332547|NCT00405158|Procedure|Breast massage|
16332548|NCT00405158|Drug|Anti-pyretic medication, paracetamol|
16332549|NCT00405158|Drug|cefadroxil|
16332550|NCT00405158|Drug|penicillin|
16332551|NCT00405158|Drug|flucloxacillin|
16332552|NCT00405119|Drug|AH23844 (lavoltidine)|
16332553|NCT00405119|Drug|NEXIUM (esomeprazole)|
16332554|NCT00405119|Drug|ZANTAC (ranitidine)|
16332555|NCT00405080|Drug|GW679769 (Casopitant) oral tablets|Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
16332556|NCT00405080|Drug|Rifampin oral capsules|Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
16332557|NCT00405067|Drug|BMS-201038 (AEGR-733)|
16332558|NCT00405067|Drug|Ezetimibe|
16332559|NCT00405054|Drug|MK0457|IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days
16332560|NCT00405041|Dietary Supplement|Dietary supplement GVG 2|2.670 g/day for 14 days
16332561|NCT00405015|Drug|rosiglitazone|Rosiglitazone 4 mg bidaily for 8 weeks
16332562|NCT00405002|Procedure|Helium dilution technique, lung CT scan|Helium dilution technique and lung CT scan
16332563|NCT00404963|Drug|placebo|
16332564|NCT00404963|Drug|GSK376501|
16332565|NCT00404937|Drug|Tobradex (Antibiotic steroid combination)|
16332566|NCT00404924|Drug|ZD6474 (vandetanib)|once daily oral tablet
16332567|NCT00404924|Other|Best Supportive Care|standard of care
16332568|NCT00404911|Behavioral|MFG therapy|MFG includes 16 weekly group therapy sessions for families with children who have ODD or CD. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment.
16332569|NCT00404911|Behavioral|Standard of Care|Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
16332570|NCT00404885|Drug|Placebo|PO BID
16332571|NCT00404885|Drug|LX211|0.2 mg/kg, twice a day (BID)
16332572|NCT00404885|Drug|LX211|0.4 mg/kg, twice a day (BID)
16332573|NCT00404885|Drug|LX211|0.6 mg/kg, twice a day (BID)
16332574|NCT00404846|Procedure|Hyperbaric Oxygenation Therapy|
16332575|NCT00404833|Drug|prednisolone and mycophenolate mofetil|
16332576|NCT00404833|Drug|prednisolone and chlorambucil|
16332577|NCT00404820|Drug|Zoledronic acid 5 mg solution|Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.
16332578|NCT00404820|Drug|Alendronate 70 mg tablets|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.
16332579|NCT00404820|Drug|Calcium/Vitamin D|Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.
16332580|NCT00404807|Device|CPAP(Continuous Positive Airway Pressure)|
16332581|NCT00404794|Drug|prednisolone and mycophenolate mofetil|
16332582|NCT00404794|Drug|prednisolone and tacrolimus|
16332583|NCT00404781|Drug|cilostazol in addition to aspirin and clopidogrel|
16332584|NCT00404768|Drug|GSK221149A|6mg/h and 12 mg/h
16332585|NCT00404768|Drug|Placebo|Matched Placebo to Drug
16332586|NCT00404755|Drug|escitalopram|Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
16332587|NCT00404755|Drug|bupropion|bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
16332588|NCT00404755|Drug|imipramine|imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
16332589|NCT00404742|Drug|Placebo|PO BID
16332590|NCT00404742|Drug|LX211|0.2 mg/kg, twice a day (BID)
16332592|NCT00404742|Drug|LX211|0.6 mg/kg, twice a day (BID)
16332593|NCT00404729|Drug|Citicoline|Ten OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes) and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600 mg/die per 60 days)
16332594|NCT00404716|Drug|Cilostazol|
16332595|NCT00404703|Drug|bevacizumab [Avastin]|15mg iv on day 1 of each 3 week cycle
16332596|NCT00404703|Drug|Platinum-based chemotherapy|As prescribed
16332597|NCT00404690|Procedure|Bedside Silo|silo placed at bedside on admission
16332598|NCT00404690|Procedure|Operative attempt at closure|go the operating room to attempt closure
16332599|NCT00404677|Other|deep inhalation|deep inhalation is comprised of an inhalation manoeuver from FRC to TLC
16332600|NCT00404664|Behavioral|influenza vaccine, reminders letters, raffle prize|
16332601|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, intramuscular (IM)
16332602|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, IM
16332603|NCT00404651|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, IM
16332604|NCT00404651|Biological|DTaP-HBV-IPV vaccine|0.5 mL, IM
16332605|NCT00404638|Drug|Desmopresin|
16332606|NCT00404638|Behavioral|Paula Method of Circular Muscle Exercise|
16332607|NCT00404625|Behavioral|Risk factors for infections due to ESBL+ Enterobacteriaceae|
16332608|NCT00404625|Behavioral|Risk factors for inadequate initial antimicrobial therapy|
16332609|NCT00404625|Behavioral|Overall and 30-day mortality in bad first antibiotic therapy|
16332610|NCT00404612|Drug|Placebo|PO BID
16332611|NCT00404612|Drug|LX211|0.2 mg/kg, twice a day (BID)
16332612|NCT00404612|Drug|LX211|0.4 mg/kg, twice a day (BID)
16332613|NCT00404612|Drug|LX211|0.6 mg/kg, twice a day (BID)
16332614|NCT00404599|Drug|atrorvastatin 10mg|Atorvastatin 10 mg once a day
16332615|NCT00404599|Drug|simvastatin 40mg|simvastatin 40mg once a day
16332616|NCT00404586|Drug|GW784568X|GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
16332617|NCT00404586|Drug|Fluticasone propionate|Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
16332618|NCT00404586|Drug|Placebo|Matching Placebo to GW784568X as aqueous nasal spray.
16332619|NCT00404573|Drug|RGH-188|
16332620|NCT00404547|Drug|Ciclesonide|Asthma Care with Alvesco
16332621|NCT00404547|Drug|Usual Care Inhaled Glucocorticosteroids|Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment
16332622|NCT00404534|Drug|Amoxicillin, Clarythromycin, Omeprazole for ten days|Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.
16332623|NCT00404521|Drug|PM02734|Administered every 3 weeks, intravenously, over 30 minutes
16332624|NCT00404508|Drug|Hydralazine and magnesium valproate|
16332625|NCT00404495|Drug|Irinotecan|Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
16332626|NCT00404495|Drug|Temozolomide|Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles
16332627|NCT00404482|Drug|Cyclosporine A|
16332628|NCT00404469|Procedure|peritendinous corticosteroid injections|1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational
16332629|NCT00404469|Procedure|eccentric decline squat training|eccentric decline unilateral squats performed twice daily. for 12 weeks
16332630|NCT00404469|Procedure|heavy slow resistance training|Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks
16332631|NCT00404456|Drug|Melatonin|Melatonin 3 mg once-daily
16332632|NCT00404443|Device|Acupuncture|Placebo-needles 17 will be used for those randomized to receive sham-acupuncture, which will be connected to the electrical current generator for the same duration and at the same acupuncture points without any current passing through, and intermittent non-specific manual twirling will also be applied. Patients are discouraged to communicate with each other before and after the treatment sessions to minimize bias.
16332633|NCT00404417|Drug|Botulinum Toxin A / Placebo|Botulinum Toxin A at first injection / Placebo at second injection
16332634|NCT00404417|Drug|Botulinum Toxin A / Botulinum Toxin A|Botulinum Toxin A at first injection / Botulinum Toxin A at second injection
16332635|NCT00404417|Drug|Placebo / Botulinum Toxin A|Placebo at first injection / Botulinum Toxin A at second injection
16332636|NCT00404417|Drug|Placebo / Placebo|Placebo at first injection / Placebo at second injection
16332637|NCT00404404|Biological|bevacizumab|
16332638|NCT00404404|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16332639|NCT00404391|Drug|Hydrocodone/Acetaminophen Extended Release|1 tablet every 12 hours
16332640|NCT00404391|Drug|Hydrocodone/Acetaminophen Extended Release|2 tablets every 12 hours
16332641|NCT00404391|Drug|Placebo|2 tablets every 12 hours
16332642|NCT00404378|Drug|ketoconazole|Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
16332643|NCT00404378|Drug|casopitant 100 mg|Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time
16332644|NCT00404378|Drug|Casopitant 50 mg|Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
16332645|NCT00404365|Other|counseling intervention|
16332646|NCT00404365|Other|screening questionnaire administration|
16332647|NCT00404365|Other|study of socioeconomic and demographic variables|
16332648|NCT00404365|Procedure|psychosocial assessment and care|
16332649|NCT00404352|Drug|RNF|Single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months, or 36 months for patients enrolled in the OL extension.
16340867|NCT00338091|Drug|Benazepril|
16332650|NCT00404352|Drug|RNF|Single dose of RNF administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
16332651|NCT00404352|Drug|Placebo|Placebo was supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 mL.
16332652|NCT00404339|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
16332653|NCT00404339|Biological|tetanus toxoid helper peptide|
16332654|NCT00404339|Procedure|adjuvant therapy|
16332655|NCT00404326|Drug|Hydralazine and magnesium valproate|
16332656|NCT00404326|Procedure|Punch biopsy of the primary tumor|
16332657|NCT00404313|Drug|MK0633|Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633
16332658|NCT00404313|Drug|Comparator: placebo|Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
16332659|NCT00404300|Drug|Optivate|Plasma-derived Factor VIII
16332660|NCT00404287|Drug|Fluvastatin|
16332661|NCT00404274|Drug|Casopitant (GW679769) oral tablets|Casopitant will be available in the dose strength of 20,30 or 50 mg
16332662|NCT00404274|Drug|Warfarin oral tablets|Warfarin will be available in the dose strength of 5 mg
16332663|NCT00404261|Drug|Fluticasone/Salmeterol HFA|Fluticasone/Salmeterol HFA, 2 puffs twice daily
16332664|NCT00404248|Drug|terameprocol|terameprocol will be given IV 5 consecutive days every 28 days. Starting dose 750mg/day. Cohorts of 3pts. A Dose Limiting Toxicity (DLT) target rate of Less than or equal to 33%. Dose levels: 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, 9300 mg.
16332665|NCT00404248|Other|pharmacological study|All pts on both arms will have pks, blood collections. 5ml of blood will be drawn on Cycle 1 day 1, Cycle 1 Day 5, Cycle 2 day 1 and Cycle 2 day 5. A total of 10 samples will be drawn at each of these time points. 1hr pre-infusion, 15 min, 1hr, 1.15, 1.5, 2, 3,4,6 and 24hr post infusion.
16332666|NCT00404235|Drug|carboplatin|
16332667|NCT00404235|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16332668|NCT00404222|Drug|Hydrocodone/Acetaminophen Extended-Release|2 tablets x 1
16332669|NCT00404222|Drug|Hydrocodone/Acetaminophen Immediate Release (NORCO®)|1 tablet q 4 hours x 3
16332670|NCT00404222|Drug|Placebo|q 4 hours x 3
16332671|NCT00404209|Procedure|Vitrectomy|pressurized 23GA vitrectomy with a 3D system
16332672|NCT00404196|Drug|Calcipotriol and LEO80122 (LEO19123 cream)|
16332673|NCT00404183|Drug|Extended-Release Hydrocodone/Acetaminophen|2 tablets BID
16332674|NCT00404183|Drug|Placebo|2 tablets BID
16332675|NCT00404170|Drug|B-CIT and SPECT imaging|Optional ongoing B-CIT SPECT imaging scans at follow-up visits
16332676|NCT00404157|Drug|Rituximab|
16332677|NCT00404144|Device|Drug Eluting Balloon|PCI of small vessels single arm study
16332678|NCT00404131|Drug|diquafosol tetrasodium (INS365) Ophthalmic Solution|
16332679|NCT00404105|Procedure|PRK|
16332680|NCT00404105|Procedure|LASIK|
16332681|NCT00404092|Drug|caspofungin|i.v.
16332682|NCT00404079|Drug|Glucosamine sulphate|Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
16332683|NCT00404079|Drug|Placebo|Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
16332684|NCT00404066|Drug|Lapatinib|1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
16332685|NCT00404066|Drug|Doxorubicin|60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
16332686|NCT00404066|Drug|Cyclophosphamide|600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
16332687|NCT00404066|Drug|Docetaxel|100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
16332688|NCT00404066|Drug|Pegfilgrastim|6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
16332689|NCT00404066|Drug|Filgrastim|300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
16332690|NCT00404066|Drug|Dexamethasone|8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
16332691|NCT00404066|Drug|Trastuzumab|Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year
16332692|NCT00404053|Drug|Clopidogrel|
16332693|NCT00404040|Drug|Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)|
16332694|NCT00404040|Drug|Lactulose|
16332695|NCT00404014|Drug|AL-208|1 dose of 300 mg
16332696|NCT00404014|Drug|Placebo|1 dose of placebo
16332697|NCT00404001|Drug|MD-0727|
16332698|NCT00403988|Drug|Oxaliplatin|
16332699|NCT00403988|Drug|vinorelbine|
16332700|NCT00403975|Drug|diquafosol tetrasodium ophthalmic solution, 2%|
16332701|NCT00403962|Drug|vestipitant/paroxetine|
16332702|NCT00403949|Drug|Azelaic acid 15% gel|gel, applied once daily, for 6 weeks
16332703|NCT00403949|Drug|Non-active base from azelaic acid 15% gel|gel, apply once daily for six weeks
16332704|NCT00403936|Procedure|OA decompression manipulation|
16332705|NCT00403923|Dietary Supplement|Lactose in water|
16332706|NCT00403910|Drug|Canrenone|
16332707|NCT00403897|Drug|Polyethylene glycol 3350 Na bicarbonate NaCl KCl|6.9g sachet, oral
16332708|NCT00403884|Procedure|Selective RPE laser treatment|interventional SRT laser treatment
16332709|NCT00403858|Drug|Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)|
16332710|NCT00403858|Drug|Lactulose|
16332711|NCT00403845|Drug|Indacaterol 150 μg|Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16332712|NCT00403845|Drug|Indacaterol 300 μg|Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16332713|NCT00403845|Drug|Placebo|Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16332714|NCT00403832|Device|intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)|
16332715|NCT00403819|Drug|Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)|
16332716|NCT00403806|Drug|dexamethasone|intravenous dexamethasone 0.05 mg per kg bodyweight
16332717|NCT00403806|Drug|Dexamethasone|Intravenous dexamethasone 0.15 mg per kg bodyweight
16332718|NCT00403806|Drug|dexamethasone|Intravenous dexamethasone 0.5 mg per kg bodyweight
16332719|NCT00403806|Drug|Saline|Intravenous saline
16332720|NCT00403793|Drug|etonogestrel with testosterone undecanoate|42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
16332721|NCT00403793|Drug|Placebo|42 or 44 weeks with placebo implant and placebo injections
16332722|NCT00403780|Drug|pregabalin|"Capsule pregabalin 75 mg once or twice daily up to a total dose of 600mg daily (300mg twice daily) for a total of minimum 14 days and maximum 8 weeks.
~Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily."
16332723|NCT00403780|Drug|placebo|Capsule placebo once or twice daily up to a total dose of 8 capsules(4 capsules twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.
16332724|NCT00403767|Drug|Rivaroxaban|Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)
16332725|NCT00403767|Drug|Warfarin|Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years
16332726|NCT00403767|Drug|Matching placebo for Rivaroxaban arm (Warfarin placebo)|Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
16332727|NCT00403767|Drug|Matching placebo for Warfarin arm (Rivaroxaban placebo)|Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
16332728|NCT00403754|Drug|Indacaterol|In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
16332729|NCT00403754|Drug|Placebo|Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
16332730|NCT00403754|Drug|Salmeterol|Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
16332731|NCT00403741|Behavioral|motivational interviewing|
16332732|NCT00403728|Drug|ciclosporine A|
16332733|NCT00403715|Drug|diquafosol tetrasodium (INS365) Ophthalmic Solution|
16332734|NCT00403702|Drug|Oxane HD [oil-RMN3-mixture]|
16332735|NCT00403702|Drug|Densiron [(F6H8)|
16332736|NCT00403689|Dietary Supplement|Beta-D-Glucan|1,5 g Beta-D-Glucan daily
16332737|NCT00403689|Dietary Supplement|placebo|1.5 g waxy maize starch daily
16332738|NCT00403676|Other|Follow up bu a nurse|Follow up bu a nurse
16332739|NCT00403676|Other|Follow up by a medical doctor|Follow up by a medical doctor
16332740|NCT00403663|Drug|bupivacaine 0.75% with fentanyl and morphine|the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine
16332741|NCT00403650|Drug|Iloprost|Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
16332742|NCT00403637|Drug|indacaterol maleate|
16332743|NCT00403624|Drug|OXALIPLATIN|
16332744|NCT00403611|Drug|Praziquantel 60 mg/kg|Praziquantel (Distocide) 60 mg/kg single oral dose
16332745|NCT00403611|Drug|Praziquantel 40 mg/kg|Praziquantel (Distocide) 40 mg/kg single oral dose
16332746|NCT00403585|Drug|adefovir dipivoxil 10mg|
16332747|NCT00403559|Drug|Elidel|
16332748|NCT00403546|Drug|Ziprasidone 80-160 mg/d|Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).
16332749|NCT00403546|Drug|Placebo|Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.
16332750|NCT00403546|Drug|Ziprasidone 160 mg/d|Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.
16332751|NCT00403533|Drug|20 mg of atorvastatin daily|
16332752|NCT00403520|Drug|Experimental 1|Drug: Donepezil Hydrochloride 10 mg orally for 12 months
16332753|NCT00403520|Drug|Placebo Comparator|Drug: Placebo Matching placebo orally for 12 months
16332754|NCT00403507|Behavioral|Participation in a monitored exercise program|No contact with control group during 20 weeks.
16332755|NCT00403507|Behavioral|Personalized aerobic and strength training.|Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
16332756|NCT00403494|Other|Placebo|Subjects receive matching oral Placebo twice daily for 24 weeks.
16332757|NCT00403494|Drug|Sapropterin Dihydrochloride|Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
16332758|NCT00403481|Drug|olmesartan medoxomil|Olmesartan medoxomil tablets, once daily
16332759|NCT00403481|Drug|Olmesartan medoxomil plus Hydrochlorothiazide|Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
16332760|NCT00403455|Drug|Paroxetine|SSRI
16332761|NCT00403442|Device|Verteporfin Therapy/ Drug: Bevacizumab|
16332762|NCT00403429|Drug|capecitabine|
16332763|NCT00403416|Drug|AEB071|
16332764|NCT00403416|Drug|Mycophenolic Acid|
16332765|NCT00403403|Drug|Bevacizumab|Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
16332766|NCT00403403|Drug|Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
16332767|NCT00403403|Drug|Placebo|Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
16332768|NCT00403390|Drug|Brand Name Levothyroxine (Synthroid)|Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.
16332769|NCT00403390|Drug|Generic formulation of Levothyroxine|Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.
16332770|NCT00403377|Behavioral|Intervention|In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
16332771|NCT00403364|Drug|Placebo amoxicillin pantoprazole clarithromycin tinidazole|
16332772|NCT00403338|Device|CYPHER® Bx Velocity™ stent (sirolimus-eluting)|
16332773|NCT00403325|Drug|rhuFab V2 [ranibizumab] ( Lucentis )|
16332774|NCT00403312|Behavioral|Smoking Cessation Behavioral Program|
16332775|NCT00403312|Drug|Nicotine Patch|
16332776|NCT00403312|Behavioral|Physical Activity|
16332777|NCT00403299|Procedure|MDCT of the coronary arteries.|
16332778|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
16332779|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
16332780|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
16332781|NCT00403286|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
16332782|NCT00403286|Drug|Fluticasone Propionate|Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
16332783|NCT00403286|Drug|Formoterol Fumarate|Inhalation Solution for nebulization 20 mcg bid for 2 weeks
16332784|NCT00403286|Drug|Fluticasone Propionate/Salmeterol Xinafoate|Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
16332785|NCT00403286|Drug|Placebo|Inhalation Solution for nebulization 2 mL bid for 2 weeks
16332786|NCT00403273|Drug|Botulinum toxin A|100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
16332787|NCT00403273|Drug|Normal Saline|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
16332788|NCT00403260|Drug|Pyronaridine - artesunate|once a day for 3 days
16332789|NCT00403260|Drug|Mefloquine plus artesunate|once a day for 3 days
16332790|NCT00403247|Dietary Supplement|Capsule with folate, Vitamin B12 & pyridoxine|
16332791|NCT00403247|Other|placebo|placebo capsule
16332792|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
16332793|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
16332794|NCT00403234|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
16332795|NCT00403234|Drug|Placebo BTDS|Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
16332796|NCT00403221|Genetic|RTVP-1 Gene|"Cohort Level #1 1.0 x 1010vp Cohort Level #2 5.0x1010vp Cohort Level #3 1.0 x 1011vp Cohort Level #4 5.0x1011vp Cohort Level #5 1.0 x 1012vp Cohort Level #6 5.0x1012vp
~One dose only followed by a radical prostatectomy 4 weeks later."
16332797|NCT00403208|Procedure|Analgesia based sedation in ICU patients|
16332798|NCT00403182|Drug|chemotherapy|
16332799|NCT00403182|Drug|letrozole|
16332800|NCT00403169|Drug|lenalidomide|drug
16332801|NCT00403156|Drug|Imatinib Mesylate /Ranibizumab|
16332802|NCT00403143|Procedure|cataract surgery|
16332803|NCT00403130|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
16332804|NCT00403130|Drug|Paclitaxel|Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
16332805|NCT00403130|Drug|Bevacizumab|Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
16332806|NCT00403117|Drug|Placebo + Inactive Marijuana (0% THC)|One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
16332807|NCT00403117|Drug|Placebo + Active Marijuana (3.27% THC)|One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse.
16332808|NCT00403117|Drug|Naltrexone 12 Mg+ Active Marijuana (3.27% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
16332809|NCT00403117|Drug|Naltrexone 25 Mg + Active Marijuana (3.27% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
16332810|NCT00403117|Drug|Naltrexone 50 Mg+ Active Marijuana (3.27% THC)|One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
16332811|NCT00403117|Drug|Naltrexone 100 Mg+ Active Marijuana (3.27% THC)|One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
16332812|NCT00403117|Drug|Naltrexone 12 Mg + Inactive Marijuana (0% THC)|One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
16332813|NCT00403117|Drug|Naltrexone 25 Mg + Inactive Marijuana (0% THC)|One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
16332864|NCT00402753|Behavioral|Ambulatory Physical Exercise Program|supervised exercise, 2 x / week
16332814|NCT00403117|Drug|Naltrexone 50 Mg + Inactive Marijuana (0% THC)|One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
16332815|NCT00403117|Drug|Naltrexone 100 Mg + Inactive Marijuana (0% THC)|One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
16332816|NCT00403104|Drug|ONO-2506PO|1200 mg QD / 18 months
16332817|NCT00403104|Drug|ONO-2506PO|0 mg QD / 18 months
16332818|NCT00403091|Behavioral|Internet Intervention|Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
16332819|NCT00403091|Behavioral|Control|The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources.
16332820|NCT00403065|Drug|dexamethasone|
16332821|NCT00403065|Procedure|quality-of-life assessment|
16332822|NCT00403065|Radiation|radiation therapy|
16332823|NCT00403052|Drug|1018 ISS immunostimulatory oligonucleotide|6 weekly subcutaneous (under the skin) injections
16332824|NCT00403039|Drug|Ranibizumab (Lucentis )|
16332825|NCT00403026|Drug|Bevacizumab ( Avastin)|
16332826|NCT00403013|Procedure|Positioning and anesthesia|Positioning during axillary plexus block
16332827|NCT00403000|Drug|dutasteride|Oral
16332828|NCT00402987|Drug|Celecoxib|dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
16332829|NCT00402987|Drug|Celecoxib|dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
16332830|NCT00402987|Drug|celecoxib|dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
16332831|NCT00402987|Drug|placebo|dose 1 placebo followed 6-12 hours later by dose 2 placebo
16332832|NCT00402974|Drug|menaquinone 7|
16332833|NCT00402961|Other|Acupuncture|Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.
16332834|NCT00402961|Other|Sham Acupuncture|Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,
16332835|NCT00402948|Drug|TPI ASM8|0.25mg, 0.5mg for 14 days, daily dosage
16332836|NCT00402948|Drug|ASM8|inhalation 0.25mg daily for 14 days
16332837|NCT00402935|Other|laboratory biomarker analysis|Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
16332838|NCT00402935|Procedure|fertility assessment and management|Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
16332839|NCT00402935|Procedure|management of therapy complications|Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
16332840|NCT00402935|Procedure|ultrasound imaging|Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
16332841|NCT00402909|Drug|Nateglinide|
16332842|NCT00402896|Drug|ZD6474|300 mg/day orally for 10 weeks.
16332843|NCT00402883|Drug|Bevacizumab|15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
16332844|NCT00402883|Drug|Pemetrexed|500mg/m2 week 1, 4, 16, 19 and 22.
16332845|NCT00402883|Procedure|Radiotherapy|1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
16332846|NCT00402883|Other|Folic Acid|350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
16332847|NCT00402883|Other|vitamin B12|1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
16332848|NCT00402883|Drug|carboplatin|AUC=5 administered intravenously weeks 1 and 4.
16332849|NCT00402870|Device|ProSeal LMA|ProSeal LMA vs Tracheal Tube
16332850|NCT00402870|Device|ProSeal LMA, Tracheal Tube|ProSeal LMA vs Tracheal Tube
16332851|NCT00402857|Behavioral|Incredible Years Program|The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.
16332852|NCT00402844|Device|Transvaginal mesh- PROLIFT®-system|
16332853|NCT00402831|Biological|ProQuad®|Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.
16332854|NCT00402805|Biological|Trivalent Inactivated Influenza Vaccine|
16332855|NCT00402792|Drug|Hydrocodone/Acetaminophen Extended-Release|1 tablet q 12 hours
16332856|NCT00402792|Drug|Hydrocodone/Acetaminophen Extended Release|2 tablets q 12 hours
16332857|NCT00402792|Drug|Placebo|2 tablets q 12 hours
16332858|NCT00402779|Drug|Erlotinib|150 mg by mouth daily
16332859|NCT00402779|Drug|Placebo|Tablet by mouth daily
16332860|NCT00402766|Drug|Cisplatin|Starting Dose: 60 mg/m^2 by vein, Over 2 Hours
16332861|NCT00402766|Drug|Imatinib Mesylate|Starting Dose: 300 mg PO Daily
16332862|NCT00402766|Drug|Pemetrexed|Starting Dose: 500 mg/m^2 by vein, Over 40 Minutes
16332863|NCT00402766|Drug|Dexamethasone|20 mg by vein given prior to Pemetrexed therapy and 4 mg given orally on Day 2 of each cycle.
16332865|NCT00402740|Device|Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)|All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).
16332866|NCT00402727|Drug|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
16332867|NCT00402727|Drug|Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
16332868|NCT00402714|Procedure|extracorporeal photopheresis|Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
16332869|NCT00402714|Drug|Pentostatin|pentostatin 8mg/m2 over 48 hours by continuous infusion
16332870|NCT00402714|Radiation|Total Body Irradiation|600cGy TBI in 3 200cGy TBI fractions
16332871|NCT00402714|Drug|Pentostatin|pentostatin 8mg/m2 over 48 hours by continuous infusion
16332872|NCT00402714|Radiation|Total Body Irradiation|600cGy TBI in 3 200cGy TBI fractions
16332873|NCT00402701|Behavioral|Walking School Bus Program|Schoolwide promotion of walk to school. Facilitation of parent-led walking school bus routes.
16332874|NCT00402688|Drug|levofloxacin|750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
16332875|NCT00402688|Drug|levofloxacin|750mg tablet once daily for 3 weeks followed by 1 week of placebo.
16332876|NCT00402688|Drug|levofloxacin|500mg tablet once daily for 4 weeks.
16332877|NCT00402675|Procedure|Timing of percutaneous coronary intervention|Immediate, early or selective invasive angiography
16332878|NCT00402662|Drug|everolimus|
16332879|NCT00402662|Drug|Imatinib|
16332880|NCT00402649|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Inactivated influenza A/H5N1 vaccine administered via intramuscular (IM) injection; dosage 45-mcg.
16332881|NCT00402636|Device|rapamycin plus 17beta estradiolvalerat-eluting stent|rapamycin plus 17beta estradiolvalerat-eluting stent was implanted due to randomisation
16332882|NCT00402636|Device|rapamycin-eluting stent|rapamycin-eluting stent was implanted due to randomisation
16332883|NCT00402623|Dietary Supplement|quercetin|1000 mg quercetin within 24 hours
16332884|NCT00402623|Other|placebo|
16332885|NCT00402610|Drug|isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment|
16332886|NCT00402597|Drug|Rivaroxaban/Placebo|1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
16332887|NCT00402597|Drug|Placebo|1 placebo tablet twice daily for 6 months.
16332888|NCT00402597|Drug|Rivaroxaban|1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.
16332889|NCT00402584|Drug|sibutramine|
16332890|NCT00402571|Drug|acetaminophen|
16332891|NCT00402558|Drug|Thymoglobulin|1.5 mg/kg By Vein Daily x 3 Days
16332892|NCT00402558|Drug|Busulfan|130 mg/m^2 By Vein Over 3 Hours x 4 Days
16332893|NCT00402558|Drug|Fludarabine|40 mg/m^2 By Vein Over 30 Minutes x 4 Days
16332894|NCT00402558|Procedure|Alloreactive NK Infusion|Alloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7.
16332895|NCT00402558|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days.
16332896|NCT00402558|Drug|Tacrolimus|Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present.
16332897|NCT00402558|Drug|Methotrexate|5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant.
16332898|NCT00402558|Drug|Interleukin-2|0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells.
16332899|NCT00402545|Drug|Cetuximab|Given intravenously on days 1, 8 and 15 of each 21-day cycle for three cycles
16332900|NCT00402545|Drug|Docetaxel|Given intravenously on day 1 of each 21-day cycle for 3 cycles
16332901|NCT00402545|Drug|Cisplatin|Intravenously on day 1 of each 21-day cycle for 3 cycles
16332902|NCT00402545|Drug|5-Fluorouracil|Given by continuous infusion pump over a period of 96 hours(dosage wil vary depending upon when participant enrolls in trial)
16332903|NCT00402532|Drug|Everolimus|Initial dosage 2 x 0.75 mg/d
16332904|NCT00402532|Drug|Mycophenolatmofetil|Initial dosage 2 x 500 mg/d intravenous
16332905|NCT00402519|Radiation|Accelerated partial breast irradiation|APBI with PDR and HDR brachytherapy
16332906|NCT00402519|Radiation|External beam whole breast irradiation|Standard Whole breast irradiation
16332907|NCT00402506|Drug|(MC-1) Pyridoxal 5'-phosphate|
16332908|NCT00402493|Drug|ibuprofen, latanoprost, brimonidine|to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
16332909|NCT00402493|Drug|Ibuprofen, brimonidine, latanoprost|to determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
16332910|NCT00402493|Drug|Ibuprofen|ibuprofen 200mg
16332911|NCT00402480|Drug|Hydroxyurea|
16332912|NCT00402467|Drug|Rivaroxaban (BAY59-7939)|2.5mg bid
16332913|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|5mg bid
16332914|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|10 mg bid
16332915|NCT00402467|Drug|Rivaroxaban, (BAY59-7939)|20mg bid
16332916|NCT00402467|Drug|Enoxaparine|30mg bid
16332917|NCT00402467|Drug|Enoxaparine|30mg bid
16340868|NCT00338091|Drug|Losartan|
16332918|NCT00402454|Drug|isoniazid, rifampin + isoniazid or rifampin + pyrazinamide|
16332919|NCT00402441|Drug|Risedronate (HMR4003)|
16332920|NCT00402428|Drug|albumin interferon alfa-2b|900 mcg or 1200mcg every two week for 48 weeks
16332921|NCT00402428|Drug|peginterferon alfa-2a|180 mcg once a week for 48 weeks
16332922|NCT00402428|Drug|Ribavirin|"1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects
~=,> 75kg)"
16332923|NCT00402415|Drug|Sunitinib malate|C1: 50 mg po days 1-15, 2 weeks off C2: 50 mg po x 4 weeks, 2 weeks off
16332924|NCT00402415|Drug|Rapamycin|"Dose escalation until MTD as follows:
~C1: not given C2: 4 mg weekly, 8 mg weekly, 12 mg weekly, 20 mg weekly"
16332925|NCT00402402|Procedure|Tuberculin skin test|
16332926|NCT00402402|Procedure|Quantiferon-TB Gold assay|
16332927|NCT00402389|Drug|Omega-3 Fatty Acids (EPA plus DHA)|Four capsules will be taken daily for 8 weeks.
16332928|NCT00402389|Behavioral|Supportive psychotherapy|Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.
16332929|NCT00402389|Drug|Placebo|Four capsules will be taken daily for 8 weeks.
16332930|NCT00402376|Drug|Pravastatin, Carvedilol, Perindopril|
16332931|NCT00402376|Device|Biventricular assist device (Thoratec paracorporeal assist device)|
16332932|NCT00402363|Drug|omega-3-acid ethyl esters|
16332933|NCT00402363|Drug|Placebo|
16332934|NCT00402350|Drug|Inhaled Placebo|Inhaled Staccato Placebo, same number of doses as active comparator in that arm
16332935|NCT00402350|Drug|Inhaled Fentanyl 25 mcg|Inhaled Staccato Fentanyl, 25 mcg x 1 dose
16332936|NCT00402350|Drug|Intravenous Fentanyl 25 mcg|Intravenous Fentanyl 25 mcg, single dose
16332937|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 2|Inhaled Staccato Fentanyl, 25 mcg x 2 doses
16332938|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 4|Inhaled Staccato Fentanyl, 25 mcg x 4 doses
16332939|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 6|Inhaled Staccato Fentanyl, 25 mcg x 6 doses
16332940|NCT00402350|Drug|Inhaled Fentanyl 25 mcg x 12|Inhaled Staccato Fentanyl, 25 mcg x 12 doses
16332941|NCT00402337|Drug|linaclotide acetate|oral, once daily.
16332942|NCT00402337|Drug|Matching placebo|oral, once daily
16332943|NCT00402324|Drug|olanzapine|15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
16332944|NCT00402324|Drug|placebo|placebo, capsules, by mouth every evening, daily, for 6 weeks.
16332945|NCT00402324|Drug|divalproex|dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
16332946|NCT00402311|Procedure|DOC-PG: integrated multidisciplinary assessment|
16332947|NCT00402311|Procedure|Usual care: assessment by GP or one of the regional services|
16332948|NCT00402298|Drug|3,4-methylenedioxymethemphetmaine (MDMA_|Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long therapy session.
16332949|NCT00402298|Drug|3,4-methylenedioxymethamphetamine|Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long therapy sessions.
16332950|NCT00402285|Dietary Supplement|lycopene supplement|
16332951|NCT00402285|Dietary Supplement|fish oil supplement|
16332952|NCT00402285|Other|Placebo|placebos for lycopene and fish oil.
16332953|NCT00402272|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16332954|NCT00402259|Drug|Esomeprazole IV|
16332955|NCT00402259|Drug|Omeprazole IV|
16332956|NCT00402246|Other|Remote Management|"The Remote Management method of treating patients consists of 3 components:
~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
16332957|NCT00402246|Other|In-Office Care|Routine in-office care
16332958|NCT00402233|Drug|Pramipexole|
16332959|NCT00402233|Drug|Placebo|
16332960|NCT00402220|Drug|TMS|Active Transcranial Magnetic Stimulation
16332961|NCT00402220|Device|Sham TMS|Sham Transcranial Magnetic Stimulation
16332962|NCT00402207|Drug|extrafine HFA-beclomethasone|
16332963|NCT00402207|Drug|HFA-fluticasone|
16332964|NCT00402194|Drug|Losartan|Tablet, 100mg, once per day for 3 months
16332965|NCT00402181|Biological|Siltuximab|Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days.
16332966|NCT00402181|Drug|Dexamethasone|Dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles and duration of each cycle is 28 days.
16332967|NCT00402168|Drug|Belatacept|IV, IV Infusion, 5 mg/kg once every 28 days for one year
16332968|NCT00402168|Drug|Cyclosporine A|Tablets, Oral, Trough of 100-250 ng/mL, 2* daily for one year
16332969|NCT00402168|Drug|Tacrolimus|Tablets, Oral, Trough of 5-10 ng/mL, 2* daily for one year
16332970|NCT00402155|Behavioral|Stress on visual discomfort|Effects of visual discomfort are measured by contrast sensitivity, ERGs, and accommodative stability.
16332971|NCT00402142|Biological|Dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
16332972|NCT00402142|Biological|non pulsed dendritic cell untreated patients|107 DC subcutaneous 3 doses every 2 weeks
16332973|NCT00402142|Biological|pulsed dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
16332974|NCT00402142|Biological|dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
16332975|NCT00402142|Biological|non pulsed dendritic cell vaccine|107 DC subcutaneous 3 doses every 2 weeks
16332976|NCT00402129|Procedure|1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.|
16332977|NCT00402116|Drug|enzastaurin|"Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles
~Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles"
16332978|NCT00402116|Drug|temozolomide|75 milligrams per meter squared (mg/m^2), oral, daily, 6 weeks then 200 mg/m^2, oral, daily, twelve 28 day cycles
16332979|NCT00402116|Radiation|radiation therapy|1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks
16332980|NCT00402103|Drug|Aliskiren|All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
16332981|NCT00402103|Drug|Amlodipine|All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
16332982|NCT00402103|Drug|Hydrochlorothiazide|Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
16332983|NCT00402077|Drug|pramlintide acetate|subcutaneous injection, three times a day, 120mcg
16332984|NCT00402077|Drug|sibutramine|oral tablet, once a day, 10mg
16332985|NCT00402077|Drug|phentermine|oral tablet, once a day, 37.5mg
16332986|NCT00402077|Drug|placebo|subcutaneous injection, three times a day
16332987|NCT00402051|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
16332988|NCT00402051|Drug|Cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles
16332989|NCT00402051|Drug|Carboplatin|Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
16332990|NCT00402038|Drug|SC Methylnaltrexone|Dose 1
16332991|NCT00402038|Drug|SC Placebo|
16332992|NCT00402025|Biological|Talimogene Laherparepvec|Talimogene laherparepvec administered by direct injection into pancreatic tumors using EUS-guided FNI, up to a maximum of 4 mL per treatment.
16332993|NCT00402012|Drug|Pioglitazone|During the double-blind, 12 weeks treatment period, subjects will self-administer study medication (pioglitazone or equivalent volume of placebo) 30 mg/day each morning. The dose of pioglitazone will be increased to 45 mg/day after 4 weeks if the fasting plasma glucose is higher than 100mg/dl or the HbA1C is higher than 7%. This dose has proven tolerability, safety and efficacy for type 2 diabetes and has previously been used at the Pennington Center in studies on pioglitazone.
16332994|NCT00401986|Device|Bronchial thermoplasty with the Alair System|Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).
16332995|NCT00401973|Drug|olanzapine|5-20 milligrams (mg), oral, daily for 22 weeks.
16332996|NCT00401973|Drug|amantadine|Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.
16332997|NCT00401973|Drug|metformin|Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.
16332998|NCT00401973|Drug|zonisamide|Zonisamide, 100-400mg, oral, daily.
16332999|NCT00401973|Behavioral|Wellness education|weight management
16333000|NCT00401960|Drug|Daptomycin|daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis
16333001|NCT00401947|Drug|ACH-0137171|
16333002|NCT00401921|Drug|Minocycline|100 mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery
16333003|NCT00401921|Drug|Placebo oral capsule|1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.
16333004|NCT00401895|Device|TIPS created with 8 or 10 mm covered stent|creation of a shunt between hepatic vein and portal vein with PTFE-covered stents
16333005|NCT00401882|Drug|Epinephrine|Epinephrine (1 mg) IV additional doses
16333006|NCT00401882|Drug|Metoprolol|Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses
16333007|NCT00401869|Drug|Epoetin alfa|
16333008|NCT00401856|Drug|Eplerenone|50mg oral route
16333009|NCT00401856|Drug|Placebo|Placebo is identical to eplerenone but the active ingredient is absent
16333010|NCT00401843|Biological|Siltuximab|Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2.
16333011|NCT00401843|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2.
16333012|NCT00401843|Drug|Placebo|Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2.
16333013|NCT00401843|Drug|Dexamethasone|Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2.
16333014|NCT00401830|Drug|Lacosamide|Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
16333015|NCT00401830|Other|Placebo|Matching placebo tablet administered twice daily
16333016|NCT00401817|Drug|Bevacizumab|15 mg/kg on day 1 of each of 6 cycles
16333017|NCT00401817|Drug|Rituximab|"Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.
~The dose to be administered is:
~Rituximab: 375 mg/m2"
16333018|NCT00401817|Drug|CHOP|Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7
16333019|NCT00401804|Drug|Dexamethasone, Bortezomib, Doxorubicin|
16333020|NCT00401791|Behavioral|Exercise|"Interval Exercise Training: Each interval training session will start with 10 minutes of warm up and will end with 10 minutes of cool down period at 40% VO2 peak. Training duration, intensity and number of exercise bout will increase with the progression of training period
~Aerobic training: Each endurance training session will start with 5 minutes of warm up and will end with 5 minutes of cool down at 40% VO2 peak. Subjects will exercise at 70% VO2 peak for 45 minutes on day 3 and 5, for 55 minutes on day 8 and 10, and for 35 minutes on day 14 using a bicycle ergometer."
16333021|NCT00401778|Drug|RAD001|Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.
16333022|NCT00401765|Drug|CNTO 328|Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.
16333023|NCT00401765|Drug|Docetaxel|Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.
16333024|NCT00401752|Drug|Esomeprazole|
16333025|NCT00401752|Drug|Ranitidine|
16333026|NCT00401739|Drug|CSL360|Weekly IV Infusion. Dose escalation study.
16333027|NCT00401726|Drug|Venlafaxine ER|
16333028|NCT00401726|Behavioral|Dialogues Time to Talk Program|
16333029|NCT00401713|Procedure|Transplantation of autologous RPE|RPE cell suspension
16333030|NCT00401713|Procedure|Translocation of autologous RPE and Choroid|RPE patch
16333031|NCT00401687|Drug|Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension|The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.
16333032|NCT00401674|Drug|carboplatin|
16333033|NCT00401674|Drug|paclitaxel|
16333034|NCT00401661|Drug|Alfuzosin|One tablet of 10mg once daily at the end of evening meal
16333035|NCT00401648|Drug|Brivaracetam|
16333036|NCT00401635|Drug|liposomal doxorubicin|
16333037|NCT00401635|Drug|carboplatin|
16333038|NCT00401622|Behavioral|OneTouch® Ultra®2 System|Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
16333039|NCT00401622|Behavioral|Standard care|Standard education and self-monitoring of blood glucose performed with traditional meter systems
16333040|NCT00401609|Drug|gemcitabine|
16333041|NCT00401609|Drug|vinorelbine|
16333042|NCT00401609|Drug|cisplatin|
16333043|NCT00401609|Drug|etoposide|
16333044|NCT00401609|Drug|carboplatin|
16333045|NCT00401596|Drug|Xolair (omalizumab)|
16333046|NCT00401583|Drug|GW786034 (pazopanib)|Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
16333047|NCT00401583|Drug|Probe drugs|probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).
16333048|NCT00401570|Drug|Volociximab|Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
16333049|NCT00401570|Drug|Gemcitabine|Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment
16333050|NCT00401544|Drug|darbepoetin alfa|Darbepoetin alfa administered by subcutaneous injection.
16333051|NCT00401544|Drug|IV iron dextran|Administered by intravenous (IV) injection.
16333052|NCT00401531|Biological|DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines|0.5 mL, IM
16333053|NCT00401531|Biological|DTaP-HB-IPV and Pneumococcal polysaccharide vaccines|0.5 mL, IM
16333054|NCT00401518|Device|Non-randomized ACADIA® Facet Replacement System|Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
16333055|NCT00401518|Device|Randomized ACADIA® Facet Replacement System|Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
16333056|NCT00401518|Device|Randomized Instrumented posterolateral fusion (PLF)|Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
16333057|NCT00401492|Drug|gemcitabine prolonged continuous infusion|
16333058|NCT00401492|Drug|cisplatin|
16333059|NCT00401492|Drug|vinorelbine|
16333060|NCT00401479|Drug|Placebo|
16333061|NCT00401479|Drug|Solabegron (GW427353)|
16333062|NCT00401466|Device|Implantable Cardioverter Defibrillator|ICD with Biotronik Home Monitoring capability
16333063|NCT00401453|Behavioral|Diet: carbohydrate days. (Name: oatmeal.)|Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.
16333064|NCT00401440|Drug|Misoprostol|400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses
16333065|NCT00401440|Drug|Misoprostol|400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses
16333066|NCT00401427|Drug|trastuzumab|
16333067|NCT00401427|Drug|vinorelbine|
16333068|NCT00401414|Drug|Warfarin|2 mg tablets take as directed by study staff (based on INR)
16333069|NCT00401401|Drug|zalutumumab|Eight weekly infusions
16333070|NCT00401401|Drug|cisplatin|Infusions
16333071|NCT00401401|Procedure|Radiotherapy|Daily in the treatment period
16333072|NCT00401388|Drug|Perifosine|Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
16333073|NCT00401388|Other|Loperamide|All patients should be instructed to take loperamide at the earliest signs of diarrhea and/or abdominal cramping after beginning perifosine.
16333074|NCT00401388|Other|Allopurinol|Patients with a known history of hyperuricemia and/or gout should receive prophylactic treatment with allopurinol 300 mg po daily.
16333075|NCT00401388|Other|Antiemetics|Antiemetic prophylaxis will be administered at the treating investigator's discretion.
16333076|NCT00401375|Drug|Methylnaltrexone|Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
16333077|NCT00401375|Drug|Placebo|Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.
16333078|NCT00401362|Drug|SC Methylnaltrexone|Dose 1
16333079|NCT00401362|Drug|SC Placebo|
16333080|NCT00401362|Drug|SC Methylnaltrexone|Dose 2
16333081|NCT00401336|Device|Magnetic resonance imaging multiecho gradient-echo sequence|Breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence
16333082|NCT00401323|Drug|docetaxel (XRP6976)|
16333083|NCT00401323|Drug|cisplatin|
16333084|NCT00401323|Drug|5-fluorouracil (5-FU)|
16333085|NCT00401310|Drug|Comparator: Placebo|Placebo IV infusions 1hr/daily over 7 days.
16333086|NCT00401310|Drug|Comparator: MK0724|MK0724 8 mg/kg/hr 1 hr/daily over 7 days.
16333087|NCT00401284|Drug|EVT 201|
16333088|NCT00401271|Drug|OPC-67683|
16333089|NCT00401271|Drug|Rifafour e-275|
16333090|NCT00401258|Drug|duloxetine|30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
16333091|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 100 mg
16333092|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 50 mg
16333093|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 25 mg, 50mg
16333094|NCT00401245|Drug|desvenlafaxine succinate sustained release|Titration 25 mg
16333095|NCT00401245|Drug|Placebo|Tapering placebo
16333096|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg, placebo
16333097|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg, 25 mg
16333098|NCT00401245|Drug|desvenlafaxine succinate sustained release|Tapering 50 mg QOD
16333099|NCT00401232|Procedure|Blood Collection|Blood Collection
16333100|NCT00401219|Drug|conjugated estrogens/progestin (MPA)|
16333101|NCT00401206|Drug|dexmedetomidine|
16333102|NCT00401193|Drug|Tranexamic acid tablets|3900 mg/Day
16333103|NCT00401193|Drug|Tranexamic acid tablets|1950 mg/Day
16333104|NCT00401193|Drug|Placebo tablets|
16333105|NCT00401180|Drug|docetaxel|administered weekly in 5 escalating doses of 25 to 35 mg/ m(2) as a one-hour bolus intravenous infusion for 3 consecutive weeks.
16333106|NCT00401180|Drug|temozolomide|administered orally daily for 3 weeks (escalating doses of 75 to 100 mg/m(2)). Cycles were repeated at 4 week intervals.
16333107|NCT00401167|Drug|memantine|Following the baseline visit, subjects will receive memantine 5 mg OD for one week, followed by 5 mg BID for one week, followed by 10 mg QAM and 5 mg QPM for one week, followed by 10 mg BID for the following 9 weeks.
16333108|NCT00401154|Other|Stationary Cycling|Use of a stationary bicycle for exercise
16333109|NCT00401141|Procedure|Blood samples|
16333110|NCT00401128|Drug|gemcitabine hydrochloride|
16333111|NCT00401128|Drug|irinotecan hydrochloride|
16333112|NCT00401115|Drug|MS-R001 (rapamycin)|Subconjunctival injection in various dosages
16333113|NCT00401115|Drug|MS-R001 (rapamycin)|Intraocular injection in various dosages
16333114|NCT00401102|Behavioral|Interpersonal Psychotherapy for Depressed Adolescents|Open clinical trial of IPT-ASI for depressed and self-injuring adolescents, 12-18 years. Goal is to assess feasibility of using IPT-A protocol for teens with co-morbid depression and self-injury. All eligible participants receive 12 weeks of individual IPT-ASI with optional monthly booster sessions. IPT-ASI is a psychosocial intervention that focuses on the importance of interpersonal relationships in relation to psychological functioning. The first phase (4 weeks) includes a review of depression and self-injury symptoms, psycho-education about depression and self-injury, and a detailed assessment of the patient's important interpersonal relationships. The middle phase (weeks 5-9) involves interpersonal skill building, including communication skills, affect identification and expression, problem solving. The final phase ( weeks 10-12) involves review of skills, generalization of skills to other relationships, termination.
16333115|NCT00401089|Drug|Panax Ginseng|The standardized extract of Panax Ginseng was formulated by Boehringer Ingelheim Pharmaton, Switzerland and fulfills the criteria of cGMP. Quality control and safety are monitored regularly by Boehringer Ingelheim Pharmaton.
16333116|NCT00401076|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks
16333117|NCT00401063|Device|Acupuncture|Acupuncture treatment twice a day for eight weeks
16333118|NCT00401050|Procedure|chiropractic manipulative therapy|
16333119|NCT00401050|Procedure|knee exercises|
16333120|NCT00401050|Procedure|Graston Instrument Soft Tissue Mobilization (GISTM)|
16333121|NCT00401024|Drug|imatinib mesylate|
16333122|NCT00401024|Other|pharmacological study|
16333123|NCT00401024|Procedure|conventional surgery|
16333124|NCT00401011|Drug|Perifosine|"Phase I: Patients will receive daily perifosine (doses 50 mg/m2 or 100 mg/m2) at bedtime.
~Phase II: All patients will receive daily perifosine at bedtime. Patients will be evaluated every 3 weeks."
16333125|NCT00401011|Drug|Bortezomib|Phase I: Patients will receive 1 mg/m2 or 1.3 mg/m2 on days 1, 4, 8, and 11 every 3 weeks. Phase II: Patients will receive bortezomib on days 1,4,8 and 11 every 3 weeks.
16333126|NCT00401011|Drug|Dexamethasone|Phase II: If the patient shows progressive disease after 3 weeks, dexamethasone 20 mg will be added to perifosine and bortezomib on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 18, and 19 to perifosine at bedtime and bortezomib IV on days 1, 4, 8, and 11 q 21 days.
16333127|NCT00400998|Drug|Fluticasone Propionate|"Subjects will receive the following treatment regimen over one of two dosing periods within each of the three study phases:
~- Intranasal FPANS (Fluticasone Propionate aqueous nasal spray) 200 mcg once daily for 8 to 14 days i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL (microlitres) i.e. 50 mcg fluticasone propionate."
16333128|NCT00400998|Other|Matched FPANS placebo|"Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
~Intranasal FPANS placebo once daily for 8 to 14 days (i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL."
16333129|NCT00400985|Device|Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.|SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.
16333131|NCT00400959|Procedure|cd133+cell intracoronary administration|
16333132|NCT00400946|Drug|asparaginase|
16333133|NCT00400946|Drug|cyclophosphamide|
16333134|NCT00400946|Drug|cytarabine|
16333135|NCT00400946|Drug|dexamethasone|
16333136|NCT00400946|Drug|dexrazoxane hydrochloride|
16333137|NCT00400946|Drug|doxorubicin hydrochloride|
16333138|NCT00400946|Drug|etoposide|Given IV
16333139|NCT00400946|Drug|leucovorin calcium|
16333140|NCT00400946|Drug|mercaptopurine|Given orally
16333141|NCT00400946|Drug|methotrexate|
16333142|NCT00400946|Drug|methylprednisolone|
16333143|NCT00400946|Drug|pegaspargase|Given IV
16333144|NCT00400946|Drug|prednisolone|
16333145|NCT00400946|Drug|therapeutic hydrocortisone|
16333146|NCT00400946|Drug|vincristine sulfate|
16333147|NCT00400946|Radiation|radiation therapy|
16333148|NCT00400933|Behavioral|psycho-education|six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
16333149|NCT00400907|Other|clinical observation|
16333150|NCT00400907|Procedure|management of therapy complications|
16333151|NCT00400881|Other|automatic tube compensation|new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.
16333152|NCT00400868|Behavioral|psycho-educational Joint protection education|individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later
16333153|NCT00400855|Drug|Fluticasone propionate|Study drug
16333154|NCT00400842|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
16333155|NCT00400842|Drug|SA-001|0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
16333156|NCT00400842|Drug|Placebo|Placebo
16333157|NCT00400829|Drug|eribulin mesylate|Given IV
16333158|NCT00400816|Drug|temozolomide|Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]
16333159|NCT00400803|Drug|Gemcitabine, Carboplatin, Bevacizumab|Patients will be treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
16333160|NCT00400790|Drug|propofol|Propofol used as the primary anaesthetic agent
16333161|NCT00400790|Drug|desflurane|Desflurane used as the primary anaesthetic
16333162|NCT00400777|Drug|Valsartan, hydrochlorothiazide and amlodipine|
16333163|NCT00400764|Drug|Dulanermin|Dulanermin was administered by intravenous (IV) infusion over 1 hour on days 1-5 of each 21-day cycle.
16333164|NCT00400764|Drug|Rituximab|Rituximab was administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
16333165|NCT00400751|Behavioral|FAMCON (Family Consultation)|
16333166|NCT00400738|Drug|Saquinavir, lopinavir, ritonavir|arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
16333167|NCT00400725|Drug|Clobex Shampoo 0.05%|twice weekly
16333168|NCT00400725|Drug|clobex shampoo placebo|twice weekly
16333169|NCT00400712|Behavioral|physical rehabilitation|two weeks intensive physical rehabilitation
16333170|NCT00400699|Other|counseling intervention|
16333171|NCT00400699|Other|study of socioeconomic and demographic variables|
16333172|NCT00400699|Procedure|psychosocial assessment and care|
16333173|NCT00400686|Biological|epoetin alfa|Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
16333174|NCT00400673|Behavioral|Two-step remission induction and risk-oriented consolidation|
16333175|NCT00400660|Drug|GSK615915A|GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
16333176|NCT00400660|Drug|Placebo|Subjects will also receive placebo inhaler.
16333177|NCT00400647|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16333178|NCT00400647|Drug|Mycophenolate mofetil|
16333179|NCT00400634|Drug|CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])|CERE-120 5.4 x 10^11 vg
16333180|NCT00400634|Procedure|Sham Surgery|Bilateral partial thickness burr holes placed, no intraparenchymal injections
16333181|NCT00400621|Drug|acetaminophen|
16333182|NCT00400608|Drug|ADVAIR HFA|
16333183|NCT00400608|Drug|ADVAIR DISKUS|
16333184|NCT00400595|Drug|Mupirocin ointment|topical ointment (already in widespread clinical use)
16333185|NCT00400595|Drug|Polysporin Triple|
16333186|NCT00400582|Drug|Candesartan up to 32 mg daily|Candesartan 4 to 32 mg daily
16333187|NCT00400569|Drug|Sunitinib Malate (SU011248)|For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.
16333188|NCT00400556|Drug|ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination|
16333189|NCT00400543|Device|Continuous positive airway pressure (CPAP)|
16333190|NCT00400530|Drug|MK0217, alendronate sodium / Duration of Treatment: 1 Month|
16333191|NCT00400530|Drug|Comparator: Alendronate-Teva / Duration of Treatment: 1 Month|
16333192|NCT00400517|Biological|sargramostim|administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
16333193|NCT00400517|Drug|thalidomide|doses up to 400 mg/day
16333194|NCT00400517|Procedure|conventional surgery|SOC care surgery
16333195|NCT00400517|Procedure|neoadjuvant therapy|post radical prostatectomy
16333196|NCT00400491|Drug|Cholecalciferol (vitamin D)|Cholecalciferol capsule 20.000 IU twice per week for 6 months
16333197|NCT00400491|Drug|Placebo|Placebo capsule twice a week, identical to the cholecalciferol capsules
16333198|NCT00400478|Drug|Rituximab|Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
16333199|NCT00400465|Procedure|Normal dressing|Normal dressing
16333200|NCT00400465|Procedure|Pressure dressing|Pressure dressing
16333201|NCT00400452|Behavioral|wheelchair skills training|
16333202|NCT00400439|Drug|dalcetrapib (RO4607381)|900mg po daily for 24 weeks
16333203|NCT00400439|Drug|placebo|po daily for 24 weeks
16333204|NCT00400426|Procedure|Radiotherapy|20 Gy in 4 fx
16333205|NCT00400413|Procedure|fMRI|
16333206|NCT00400400|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
16333207|NCT00400400|Drug|Mycophenolate mofetil|Mycophenolate mofetil supplied as 250 mg capsules.
16333208|NCT00400400|Drug|Placebo to mycophenolate sodium|Placebo to mycophenolate sodium matching tablets.
16333209|NCT00400400|Drug|Placebo to mycophenolate mofetil|Placebo to mycophenolate mofetil matching capsules.
16333210|NCT00400387|Drug|Fragmin P Forte (dalteparin sodium)|subcutaneous injection, once daily supported by multivitamine supplement and close monitoring
16333211|NCT00400387|Dietary Supplement|Multivitamin supplement|general pregnancy support by multivitamin supplementation and close monitoring
16333212|NCT00400374|Drug|Erlotinib|Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
16333213|NCT00400374|Drug|Celecoxib|Celecoxib, 400 mg, daily for 6 months.
16333214|NCT00400361|Drug|RG1507|Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
16333215|NCT00400348|Drug|Panzem Nanocrystal Colloidal Dispersion (NCD)|Panzem NCD 1,000 mg, four times daily for 28 consecutive days
16333216|NCT00400335|Drug|Nanomilled testosterone|
16333217|NCT00400335|Drug|commercially available dutasteride|
16333218|NCT00400335|Drug|Nanomilled dutasteride|
16333219|NCT00400322|Drug|Valganciclovir (Valcyte)|
16333220|NCT00400322|Other|Placebo|
16333221|NCT00400309|Biological|REPEVAX® after REVAXIS®|Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
16333222|NCT00400309|Biological|REPEVAX® after Placebo|Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
16333223|NCT00400296|Drug|RG547|Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
16333224|NCT00400283|Drug|NNC 55-0414|
16333225|NCT00400270|Procedure|Breathing and relaxation exercises: the Papworth Method|
16333226|NCT00400257|Behavioral|Early detection of heart failure|Early detection of heart failure
16333227|NCT00400244|Procedure|Wheelchair skills traing program|
16333228|NCT00400231|Drug|Study drugs: Metformin and fenofibrate|145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
16333229|NCT00400231|Drug|Study Drug: Metformin|2000mg/day
16333230|NCT00400231|Drug|Study Drug: fenofibrate|145mg/day of fenofibrate
16333231|NCT00400231|Drug|Metformin and Fenofibrate placebo|placebo metformin and fenofibrate
16333232|NCT00400218|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks|
16333233|NCT00400205|Drug|Docetaxel|Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
16333234|NCT00400205|Drug|Cisplatin|Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
16333235|NCT00400205|Drug|5-fluorouracil|5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
16333236|NCT00400179|Drug|S-1/Cisplatin|"In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.
~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin."
16333237|NCT00400179|Drug|5-FU/cisplatin|In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.
16333238|NCT00400166|Behavioral|Recovery Mentor|Provided Recovery Mentor services
16333239|NCT00400153|Drug|Atrovent Respimat (20 mcg)|
16333240|NCT00400153|Drug|COMBIVENT MDI (36/206 mcg)|
16333241|NCT00400153|Drug|Combivent Respimat (20 mcg/100 mcg)|
16333242|NCT00400153|Drug|Placebo via corresponding inhaler for blinding purposes|
16333243|NCT00400140|Device|Hyperopic lens|+3 D glasses
16333244|NCT00400127|Device|Silesian suspension belt|
16333245|NCT00400114|Drug|Irinotecan|Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
16333246|NCT00400114|Drug|Cisplatin|Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
16333247|NCT00400114|Procedure|Radiation|Radiation 50 Gy (weeks 4-9)
16333248|NCT00400114|Procedure|Surgery|Esophagectomy
16333249|NCT00400114|Drug|sunitinib (Sutent)|sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.
16333250|NCT00400101|Biological|Virosome-formulated synthetic peptides (malaria vaccine)|
16333251|NCT00400088|Drug|paroxetine|Start at 20 mg po od. Increase dose to 40 mg po od at week 4 if there is less than 20 % reduction in MADRS scores.
16333252|NCT00400088|Drug|lithium|start at 600mg po hs with dose to be flexibly titrated to a serum level of between 0.6 and 1.1 mmol/l.
16333253|NCT00400075|Drug|azathioprine|
16333254|NCT00400075|Drug|cyclophosphamide|
16333255|NCT00400036|Behavioral|Cod protein NCEP-diet|
16333256|NCT00400023|Drug|S-1|"During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
~During the S-1 Extension Phase (Part 2), S-1 30 mg/m2 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
16333257|NCT00400023|Drug|FT|During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
16333362|NCT00399165|Drug|Dutasteride|dutasteride 0.5 mg orally, once daily for 28 days
16340985|NCT00337194|Other|placebo|Given IV
16333258|NCT00400010|Behavioral|Expert System Intervention|Questionnaires on motivation to change and alcohol consumption were assessed in a clinical interview. Data were entered in a Computer and a fully automatized feedback letter was generated by an expert system. The printed feedback letter was handed out to patients by study staff the following day.
16333259|NCT00399997|Behavioral|Exercise on Prescription|
16333260|NCT00399984|Behavioral|Asthma Education Program|interactive seminars regarding daily inhaled corticosteroids
16333261|NCT00399971|Procedure|Ex Vivo Immunotherapy|Allogeneic and autologous ex vivo activated immune cells are given intravenously at least once a week
16333262|NCT00399971|Drug|Ex vivo immunotherapy|i.v. infusions, once a week, at least 6 to 12 months
16333263|NCT00399945|Drug|Tobramycin|
16333264|NCT00399919|Drug|Propionyl-L-Carnitine|2 grams per day for six months
16333265|NCT00399919|Drug|PLC|2 grams/day for six months
16333266|NCT00399906|Drug|BMS-582949|Tablets, Oral, Once daily, 12 weeks
16333267|NCT00399906|Drug|Placebo|Tablets, Oral, Once daily, 12 weeks
16333268|NCT00399893|Drug|Octreotide|Octreotide to be administered by subcutaneous injection three times daily
16333269|NCT00399893|Drug|Placebo|Placebo to be administered by subcutaneous injection three times daily while on study
16333270|NCT00399880|Behavioral|Health literacy intervention|Illustrated medication schedules, pill boxes, pharmacist counseling
16333271|NCT00399867|Drug|Simvastatin|
16333272|NCT00399854|Device|Dhermia® - Industra Mecânica Fina Ltda|
16333273|NCT00399841|Device|Precision for Spinal Cord Stimulation|During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
16333274|NCT00399828|Device|TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)|
16333275|NCT00399802|Drug|ZA|Single ZA 4 mg IV infusion at the start of treatment
16333276|NCT00399802|Drug|Odanacatib|Once-daily odanacatib 5 mg tablet for 4 weeks
16333277|NCT00399802|Drug|Odanacatib matching placebo|Once-daily odanacatib matching placebo for 4 weeks
16333278|NCT00399802|Drug|ZA matching placebo|Single IV infusion of ZA matching placebo given at the start of treatment
16333279|NCT00399789|Drug|Perifosine|Perifosine will be tested in 3 dose forms
16333280|NCT00399776|Radiation|Bone Density Test|Evaluating bone mineral content and bone metabolism in adolescents on antipsychotic therapy compared to healthy adolescents
16333281|NCT00399763|Drug|Atomoxetine|Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder
16333282|NCT00399763|Drug|Placebo|Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
16333283|NCT00399750|Drug|oxaliplatin|
16333284|NCT00399750|Drug|fluoropyrimidine|
16333285|NCT00399750|Drug|bevacizumab|
16333286|NCT00399737|Drug|repeated intake of fermented milk followed by a single oral dose of an ACE inhibitor|
16333287|NCT00399724|Drug|Insulin glargine|
16333288|NCT00399711|Drug|repaglinide and metformin combination tablet|
16333289|NCT00399711|Drug|rosiglitazone and metformin combination tablet|
16333290|NCT00399698|Drug|Risperdal|
16333291|NCT00399685|Drug|Ortho Tri-Cyclen LO|Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
16333292|NCT00399685|Drug|Ortho Cyclen|Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
16333293|NCT00399685|Drug|Ortho Cyclen + Efavirenz|Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
16333294|NCT00399685|Drug|Ortho Cyclen|Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
16333295|NCT00399672|Drug|Interferon injections and ribavirin|Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
16333296|NCT00399672|Drug|Interferon injections and ribavirin|Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.
16333297|NCT00399659|Drug|Tegaserod|
16333298|NCT00399646|Device|Metricath Gemini System|
16333299|NCT00399633|Drug|sumatriptan|
16333300|NCT00399620|Procedure|Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).|
16333301|NCT00399607|Procedure|Rectal biopsy during colonoscopy|Biopsies of rectal tissue will be obtained during the 3 or 5 year follow-up colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
16333302|NCT00399607|Procedure|Rectal biopsy at randomization|Biopsies of rectal tissue will be obtained at the time of randomization. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
16333303|NCT00399607|Procedure|Rectal biopsy at 1 year|Biopsies of rectal tissue will be obtained at the time of the one year follow-up visit. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
16333363|NCT00399165|Other|placebo sesame oil|placebo sesame oil
16333364|NCT00399165|Drug|Dutasteride|24.5 mg po once (Day 0)
16333365|NCT00399152|Drug|Perifosine|Perifosine Oral Dose
16333366|NCT00399152|Drug|Sunitinib Malate|Sunitinib oral dose
16333367|NCT00399126|Drug|Perifosine|Perifosine oral dose
16333304|NCT00399607|Procedure|Rectal biopsy prior to colonoscopy|Biopsies of rectal tissue will be obtained 7-21 days prior to the 3 or 5 year colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
16333305|NCT00399607|Procedure|Biopsies during colonoscopy|Biopsies of the rectum, sigmoid colon and ascending colon will be obtained during the 3-5 year follow-up colonoscopy. The colonoscopy involves insertion of a flexible tube through the anus, which is then advanced the full length of the colon. Biopsies (tiny pinches of tissue less than 1/16 of an inch thick) will be taken as the colonoscopy tube is being removed. In total, 12-16 biopsies will be taken from the rectum (or lower colon about 3 - 4 inches up), sigmoid colon and ascending colon.
16333306|NCT00399594|Procedure|A|LV lead placement in region of latest mechanical velocity (tissue doppler)
16333307|NCT00399594|Procedure|B|LV lead placement in standard (lateral / posterolateral) position.
16333308|NCT00399581|Procedure|High Frequency Oscillatory Ventilation-Hi|HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.
16333309|NCT00399581|Procedure|High Frequency Oscillatory Ventilation-Lo|HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.
16333310|NCT00399568|Drug|IV Acetaminophen|Intravenous acetaminophen 1 g/100 mL
16333311|NCT00399568|Drug|IV Placebo 100 mL solution|IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
16333312|NCT00399542|Drug|Lubiprostone|
16333313|NCT00399542|Drug|Placebo|
16333314|NCT00399529|Biological|Allogeneic GM-CSF-secreting breast cancer vaccine|the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 108 cells for each patient and each vaccination cycle) on day 0.
16333315|NCT00399529|Drug|Trastuzumab|Trastuzumab is a humanized monoclonal antibody specific for the extracellular domain of HER-2/neu that is now one component of the standard of care for both early and late stage HER-2/neu-overexpressing breast cancers. It exerts a pleiotropic antitumor effect by multiple mechanisms. The antibody decreases heterodimer formation with other members of the epidermal growth factor receptor (EGFR) family, thereby indirectly inhibiting signaling through the Ras/Raf/mitogen-activated protein kinases (MAPK) and Phosphatidylinositol 3-kinase(PI3K)/protein kinase B (Akt) pathways. It also inhibits tumor neovascularization, and augments apoptosis both in vitro and in vivo. Trastuzumab prevents cleavage of the extracellular domain of HER-2/neu, thus abrogating the constitutive activation of the remaining membrane-associated intracellular domain.
16333316|NCT00399529|Drug|Cyclophosphamide|The doses of Cyclophosphamide are based on previously reported clinical experience as well as our own preclinical data demonstrating augmented vaccine efficacy with CY-modulated vaccination. In particular, 300 mg/m2
16333317|NCT00399516|Device|Precision|
16333318|NCT00399503|Procedure|Spectral T Wave Alternans|
16333319|NCT00399503|Procedure|Modified Moving Average T Wave Alternans|
16333320|NCT00399503|Procedure|Baroreceptor Sensitivity|
16333321|NCT00399503|Procedure|Heart Rate Variability|
16333322|NCT00399503|Procedure|Heart Rate Turbulence|
16333323|NCT00399503|Procedure|Deceleration Capacity|
16333324|NCT00399503|Procedure|Signal Averaged ECG|
16333325|NCT00399490|Drug|RN624 (PF-04383119)|50 mcg/kg
16333326|NCT00399477|Drug|rasagiline mesylate|Azilect®
16333327|NCT00399477|Drug|Rasagiline mesylate plus Mirapex|Mirapex, Azilect®
16333328|NCT00399477|Drug|Rasagiline mesylate with Levodopa|Azilect®, Levodopa
16333329|NCT00399477|Drug|Rasagiline mesylate with Requip|Azilect®, Requip
16333330|NCT00399464|Drug|alfuzosin|
16333331|NCT00399451|Drug|Polidocanol Sclerotherapy|
16333332|NCT00399438|Drug|Placebo|Tablets, Oral, once daily, 2 weeks
16333333|NCT00399438|Drug|BMS-562086|Tablets, Oral, once daily, 2 weeks
16333334|NCT00399425|Drug|bemiparin (low molecular weight heparin)|
16333335|NCT00399412|Device|subcutaneous ICD|
16333336|NCT00399399|Drug|azathioprine|
16333337|NCT00399399|Drug|cyclophosphamide|
16333338|NCT00399386|Procedure|EP|
16333339|NCT00399386|Procedure|ICD|
16333340|NCT00399386|Procedure|Ablation|
16333341|NCT00399360|Drug|Metformin|Starting at 500 mg twice daily and increasing to 850 mg twice daily after 3 Months
16333342|NCT00399360|Drug|Placebo|500 mg twice daily increasing to 850 mg twice daily after 3 Months
16333343|NCT00399360|Behavioral|Lifestyle Modification|Lifestyle Modification
16333344|NCT00399334|Drug|antipsychotic medications|as prescribed
16333345|NCT00399308|Device|Celaderm (Frozen Cultured Epidermal Allograft)|Four biweekly applications of Celaderm plus compression therapy
16333346|NCT00399308|Device|Celaderm (Frozen Cultured Epidermal Allograft)|Four weekly applications of Celaderm plus compression therapy
16333347|NCT00399308|Device|Control (compression bandaging)|Multi-layer compression bandaging
16333348|NCT00399295|Drug|Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.|
16333349|NCT00399282|Drug|Omega-3 and Vitamin E supplementation|
16333350|NCT00399269|Drug|Recombinant Human Erythropoietin alpha|
16333351|NCT00399256|Drug|Acetylcysteine|
16333352|NCT00399256|Drug|Zinc|
16333353|NCT00399243|Drug|Sumatriptan 4mg Statdose injection|4mg Sumatriptan Statdose injection for use as acute therapy in a cluster headache. Consistency of response in three attacks will be measured
16333354|NCT00399230|Drug|Optive|
16333355|NCT00399217|Device|Subcutaneous Implantable Defibrillator (S-ICD) system|
16333356|NCT00399217|Device|ICD|
16333357|NCT00399204|Drug|Pioglitazone vs Metformin|
16333358|NCT00399191|Drug|stable isotope of iron, dysprosium|
16333359|NCT00399178|Drug|Transdermal delivery system|
16333360|NCT00399165|Drug|Testosterone Enanthate|Oral Testosterone 400 mg orally for 28 days
16333361|NCT00399165|Drug|Testosterone Enanthate|Oral Testosterone 800 mg orally for 28 days
16333368|NCT00399126|Drug|Paclitaxel|Paclitaxel IV
16333369|NCT00399113|Drug|188Re-PTI-6D2|monoclonal antibody
16333370|NCT00399100|Procedure|HBO - hyperbaric oxygen treatment|
16333371|NCT00399087|Drug|Perifosine|Perifosine oral administration
16333372|NCT00399087|Drug|Docetaxel|IV administration
16333373|NCT00399087|Drug|Prednisone|Oral administration
16333374|NCT00399074|Drug|sulfadoxine pyrimethamine|Monthly SP
16333375|NCT00399061|Drug|Systane, Optive, Restasis|Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed
16333376|NCT00399048|Drug|OROS hydromorphone HCL ; OxyContin|
16333377|NCT00399035|Drug|Cediranib|oral tablet
16333378|NCT00399035|Drug|FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)|intravenous infusion
16333379|NCT00399035|Drug|XELOX (Capecitabine and Oxaliplatin)|intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
16333380|NCT00399035|Drug|Cediranib Placebo|oral tablet
16333381|NCT00399022|Drug|Duloxetine|
16333382|NCT00399009|Device|AutoSuture Premium Plus CEEA/Ethicon Proximate ILS|
16333383|NCT00398996|Drug|Early versus intermediate versus late initiation of ART|Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed
16333384|NCT00398983|Drug|Decitabine|20 mg/m^2 IV over 1 hour daily for 5 days
16333385|NCT00398970|Device|Endobronchial ultrasound miniprobe|Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.
16333386|NCT00398957|Drug|OROS® Hydromorphone HCL; OROS® Dilaudid; Dilaudid SR (slow release); Naltrexone (an opioid antagonist).|
16333387|NCT00398944|Device|Evaluation of the impact of a guideline based computerized decision support system.|
16333388|NCT00398931|Drug|MK0217, alendronate sodium / Duration of Treatment : 5 Years|
16333389|NCT00398931|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 5 Years|
16333390|NCT00398918|Drug|zonisamide|zonisamide (100 mg)one time
16333391|NCT00398918|Drug|Placebo|Placebo Comparator
16333392|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|2,5 mg twice daily (5 mg total daily dose)
16333393|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|5 mg twice daily (10 mg total daily dose)
16333394|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|10 mg twice daily (20 mg total daily dose)
16333395|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|20 mg twice daily (40 mg total daily dose)
16333396|NCT00398905|Drug|Rivaroxaban (Xarelto, BAY59-7939)|30 mg twice daily (60 mg total daily dose)
16333397|NCT00398905|Drug|Enoxaparin|40 mg once daily (40 mg total daily dose)
16333398|NCT00398892|Drug|Lipoic acid|Lipoic acid capsules
16333399|NCT00398879|Drug|Perifosine|Perifosine 50 mg/d qd
16333400|NCT00398879|Drug|Capecitabine|Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
16333401|NCT00398879|Other|Perifosine Placebo|Placebo to Perifosine 50 mg/d qd
16333402|NCT00398866|Drug|Synvisc (Hylan G-F20; hyaluronan injection)|1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
16333403|NCT00398866|Drug|Bupivicaine (local anesthesia injection)|1 ml of bupivicaine 0.5% injected once a week for 2 weeks
16333404|NCT00398866|Drug|Kenalog (triamcinolone; corticosteroid injection)|1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
16333405|NCT00398853|Dietary Supplement|chromium picolinate 1000 mcg daily vs placebo|chromium picolinate 1000 mcg daily vs placebo
16333406|NCT00398853|Other|Placebo|Placebo
16333407|NCT00398840|Drug|ARQ 171|
16333408|NCT00398827|Drug|Dexmedetomidine|
16333409|NCT00398827|Drug|Placebo|
16333410|NCT00398814|Drug|Perifosine|For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
16333411|NCT00398814|Drug|Sorafenib|For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
16333412|NCT00398788|Drug|OROS® hydromorphone HCL; Dilaudid CR (controlled release); Dilaudid IR (immediate release) as rescue medicine|
16333413|NCT00398775|Procedure|antibiotic discontinuation|
16333414|NCT00398749|Drug|Epoetin alfa|40,000 IU once weekly, variable treatment length
16333415|NCT00398736|Procedure|sonographic measurement of inferior caval vein diameter|
16333416|NCT00398723|Device|Narrowband UVB|Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema
16333417|NCT00398710|Drug|Perifosine|150 mg daily (100 mg daily in case of dose reduction)
16333418|NCT00398697|Drug|Perifosine|
16333419|NCT00398697|Drug|Gemcitabine|
16333420|NCT00398684|Drug|Single dose nevirapine to the mother and to the child|One maternal 200 mg NVP dose at the onset of labor, and one dose of infant NVP (0.6 ml/6mg) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
16333421|NCT00398684|Drug|Single dose nevirapine to the mother and placebo to the child|One maternal 200 mg NVP dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
16333422|NCT00398684|Drug|Single dose placebo to the mother and to the child|One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. [Infants less than 2,500g received only 0.2mL/kg]
16333423|NCT00398671|Device|Application of cool cap after primary successful CPR|
16333424|NCT00398658|Drug|gentamycin and clindamycin|
16333425|NCT00398645|Drug|GW685698X 200mcg,GW685698X 200mcg and 400mcg|
16333549|NCT00397865|Behavioral|Educational booklet|Parental perception of educational booklet and evaluating any change in child's weight.
16333426|NCT00398632|Drug|Duloxetine|dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
16333427|NCT00398619|Drug|INCB13739|
16333428|NCT00398606|Drug|MK0217, alendronate sodium / Duration of Treatment : 2 Years|
16333429|NCT00398606|Drug|Comparator : calcium carbonate /Duration of Treatment : 2 Years|
16333430|NCT00398593|Behavioral|Range of electronic pill dispensers with alarms|Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
16333431|NCT00398580|Drug|Nanomilled testosterone|
16333432|NCT00398580|Drug|Nanomilled dutasteride|
16333433|NCT00398580|Drug|commercially available dutasteride|
16333434|NCT00398567|Drug|HKI-272|HKI-272 by mouth
16333435|NCT00398567|Drug|trastuzumab|trastuzumab 4 mg/kg IV as a loading dose followed by trastuzumab 2 mg/kg weekly thereafter
16333436|NCT00398554|Drug|cyclophosphamide|1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
16333437|NCT00398554|Drug|doxorubicin hydrochloride|25mg/m²/day, 2 hours i.v.infusion on day 21
16333438|NCT00398554|Drug|etoposide|150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
16333439|NCT00398554|Drug|prednisone|40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
16333440|NCT00398554|Drug|vinblastine sulfate|6 mg/m² i.v. bolus on day 1 and day 21
16333441|NCT00398554|Drug|vincristine sulfate|1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
16333442|NCT00398554|Radiation|radiation therapy|involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)
16333443|NCT00398541|Drug|losartan potassium (+) hydrochlorothiazide|losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25
16333444|NCT00398528|Drug|Glatiramer acetate, (Copaxone®)|
16333445|NCT00398528|Drug|IFN-β-1a, (Avonex®)|
16333446|NCT00398515|Drug|lenalidomide|Given orally
16333447|NCT00398515|Drug|temsirolimus|Given IV
16333448|NCT00398515|Other|pharmacological study|Correlative studies
16333449|NCT00398515|Other|laboratory biomarker analysis|Correlative studies
16333450|NCT00398502|Drug|MOA-728|
16333451|NCT00398489|Biological|trastuzumab|
16333452|NCT00398489|Drug|anastrozole|
16333453|NCT00398489|Drug|cyclophosphamide|
16333454|NCT00398489|Drug|docetaxel|
16333455|NCT00398489|Drug|epirubicin hydrochloride|
16333456|NCT00398489|Drug|goserelin acetate|
16333457|NCT00398489|Drug|tamoxifen citrate|
16333458|NCT00398489|Procedure|adjuvant therapy|
16333459|NCT00398489|Procedure|conventional surgery|
16333460|NCT00398489|Procedure|neoadjuvant therapy|
16333461|NCT00398489|Radiation|radiation therapy|
16333462|NCT00398476|Drug|fluticasone propionate (FP)|200 micrograms (mcg); an aqueous suspension of microfine FP
16333463|NCT00398476|Drug|fluticasone furoate (FF)|110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
16333464|NCT00398463|Drug|Tirofiban|Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
16333465|NCT00398463|Drug|Placebo|Saline infusion will be administered for 14-24 hours
16333466|NCT00398450|Biological|recombinant interferon alfa-2b|
16333467|NCT00398450|Drug|azacitidine|
16333468|NCT00398437|Biological|trastuzumab|
16333469|NCT00398437|Drug|chemotherapy|
16333470|NCT00398437|Procedure|magnetic resonance imaging|
16333471|NCT00398424|Drug|S-1/Cisplatin|"PK Phase (Part 1), Beginning on Day 1 of the Pharmacokinetic Phase, 30 mg/m2 S-1 will be administered orally BID for 14 days (Days 1 through 14), followed by a 1-week recovery period.
~On Day -2 and Day 14 of the Pharmacokinetic Phase, all patients will receive a single dose of 30 mg/m2 S-1 administered orally.
~Extension Phase, Patients will receive S-1 at the dose that they tolerated in the PK Phase. S-1 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
16333472|NCT00398411|Drug|moxifloxacin|400 mg p.o. per day
16333473|NCT00398411|Drug|placebo|one tablet per day p.o.
16333474|NCT00398398|Drug|Capecitabine, Oxaliplatin, Cetuximab|Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
16333475|NCT00398385|Drug|cisplatin|
16333476|NCT00398385|Drug|gemcitabine hydrochloride|
16333477|NCT00398385|Procedure|adjuvant therapy|
16333478|NCT00398385|Procedure|conventional surgery|
16333479|NCT00398385|Procedure|neoadjuvant therapy|
16333480|NCT00398372|Drug|Rituximab|
16333481|NCT00398372|Drug|Epratuzumab|
16333482|NCT00398359|Behavioral|Motivational Interviewing (physicians)|Identifying and referring children with BMI >93%.
16333483|NCT00398359|Behavioral|Behavior Modification (families)|Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.
16333484|NCT00398333|Dietary Supplement|Eicosapentaenoic acid enriched nutritional supplement|Oral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study.
16333485|NCT00398320|Drug|Capecitabine|850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycle
16333486|NCT00398320|Drug|Oxaliplatin|130 mg/m2 intravenously on day 1 of a 21 day cycle
16333487|NCT00398320|Drug|Bevacizumab|7.5mg/kg Intravenous on day 1 of a 21 day cycle
16333546|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
16333547|NCT00397878|Drug|saracatinib|Given orally
16333548|NCT00397878|Other|laboratory biomarker analysis|Correlative studies
16341361|NCT00334672|Drug|methotrexate|
16333488|NCT00398307|Drug|S-1/Cisplatin|"S-1 administration will be determined by degree of renal impairment as follows:
~Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD
~Pharmacokinetic Phase (Part 1):
~On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning.
~Treatment will be followed by 1 week of recovery (Days 15 through 21).
~Extension Phase (Part 2):
~S-1 will be administered orally for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
16333489|NCT00398294|Drug|MK0733, simvastatin / Duration of Treatment: 12 Weeks|
16333490|NCT00398281|Drug|dutasteride|Given orally
16333491|NCT00398281|Other|placebo|Given orally
16333492|NCT00398268|Procedure|Kirschner-wire fixation|
16333493|NCT00398255|Behavioral|self-management program|
16333494|NCT00398242|Device|above or below elbow cast for the last 3 weeks of treatment|
16333495|NCT00398229|Drug|s.c. human chorionic gonadotropin (Ovitrelle)|S.C. Ovitrelle 250 mcg once
16333496|NCT00398216|Drug|DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor|
16333497|NCT00398203|Device|NaviAid™ BGE Device|NaviAid™ Balloon Guided Endoscopy Device
16333498|NCT00398190|Behavioral|Control|Standard anti-tobacco programming
16333499|NCT00398190|Behavioral|Media Literacy|Anti-smoking media literacy curriculum intervention
16333500|NCT00398151|Drug|MK0476, montelukast sodium / Duration of Treatment: 12 Weeks|
16333501|NCT00398138|Biological|WT-1 analog peptide vaccine|
16333502|NCT00398138|Biological|incomplete Freund's adjuvant|
16333503|NCT00398138|Biological|sargramostim|
16333504|NCT00398138|Genetic|polymerase chain reaction|
16333505|NCT00398138|Other|flow cytometry|
16333506|NCT00398138|Other|immunoenzyme technique|
16333507|NCT00398125|Drug|GSK364735|
16333508|NCT00398112|Drug|sunitinib malate|Given orally
16333509|NCT00398112|Other|pharmacological study|Correlative studies
16333510|NCT00398112|Other|laboratory biomarker analysis|Correlative studies
16333511|NCT00398099|Drug|MK0826, ertapenem sodium / Duration of Treatment: 14 Days|
16333512|NCT00398086|Drug|Gemcitabine|Administered by intravenous infusion over 30 minutes.
16333513|NCT00398086|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion over 30 minutes.
16333514|NCT00398073|Biological|mouse gp100 plasmid DNA vaccine|
16333515|NCT00398073|Device|The Dermal PowderMed® devices|
16333516|NCT00398073|Other|intramuscularly (IM injection)|
16333517|NCT00398060|Behavioral|Cognitive-behavioral life-style counseling|
16333518|NCT00398047|Drug|Azacitadine and Hematopoietic Growth Factors|Combination of Azacitadine and Hematopoietic Growth Factors
16333519|NCT00398034|Drug|Testosterone Gel|
16333520|NCT00398008|Drug|Buprenorphine/Subutex|Opioid agonist medication to treat opiate dependence
16333521|NCT00398008|Drug|Naltrexone|Opioid antagonist medication to treat opiate dependence
16333522|NCT00398008|Behavioral|Drug counseling|DC-HIV: Drug Counseling that provides education about HIV, drug abuse and dependence; encourages medication adherence; uses motivational enhancement techniques; encourages life style changes; and teaches cognitive and behavioral coping skills to prevent relapse
16333523|NCT00397995|Procedure|above- or under elbow cast|
16333524|NCT00397982|Biological|Bevacizumab|Given IV
16333525|NCT00397982|Other|Laboratory Biomarker Analysis|Correlative studies
16333526|NCT00397982|Drug|Temsirolimus|Given IV
16333527|NCT00397982|Procedure|Therapeutic Conventional Surgery|Undergo tumor resection
16333528|NCT00397969|Other|counseling intervention|
16333529|NCT00397969|Procedure|screening colonoscopy|
16333530|NCT00397956|Drug|MK0826, ertapenem sodium / Duration of Treatment: 14 Days|
16333531|NCT00397943|Biological|GSK's candidate Mycobacterium tuberculosis vaccine 692342|Intramuscular injection, 2 doses at 0, 1 month
16333532|NCT00397943|Biological|Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system|Intramuscular injection, 2 doses at 0, 1 month
16333533|NCT00397943|Biological|Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline|Intramuscular injection, 2 doses at 0, 1 month
16333534|NCT00397943|Biological|Control vaccine with the adjuvant system.|Intramuscular injection, 2 doses at 0, 1 month
16333535|NCT00397930|Procedure|Standard Care Control Condition|Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
16333536|NCT00397930|Procedure|Yoga Intervention (YOCAS)|The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
16333537|NCT00397917|Drug|Folic acid: 4 mg versus 0.4 mg per day|Folic acid
16333538|NCT00397904|Biological|cetuximab|
16333539|NCT00397904|Drug|cisplatin|
16333540|NCT00397904|Drug|irinotecan hydrochloride|
16333541|NCT00397904|Other|immunohistochemistry staining method|
16333542|NCT00397904|Other|laboratory biomarker analysis|
16333543|NCT00397904|Procedure|biopsy|
16333544|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
16333545|NCT00397891|Drug|bapineuzumab|The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
16333550|NCT00397852|Procedure|Kirschner-wires or not|
16333551|NCT00397839|Drug|Ibandronate|Ibandronate orally (tablet) at a dose of 150 mg once per month
16333552|NCT00397839|Drug|placebo|Placebo orally (tablet) at a dose of 150 mg once per month
16333553|NCT00397826|Drug|MK0733|Duration of Treatment: 12 Weeks
16333554|NCT00397813|Drug|Cyclosporine|Given PO
16333555|NCT00397813|Drug|Fludarabine Phosphate|Given IV
16333556|NCT00397813|Other|Laboratory Biomarker Analysis|Correlative studies
16333557|NCT00397813|Drug|Mycophenolate Mofetil|Given PO
16333558|NCT00397813|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo transplantation
16333559|NCT00397813|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplant
16333560|NCT00397813|Radiation|Total-Body Irradiation|Undergo TBI
16333561|NCT00397800|Biological|rituximab|
16333562|NCT00397800|Drug|cyclophosphamide|
16333563|NCT00397800|Drug|fludarabine phosphate|
16333564|NCT00397800|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16333565|NCT00397787|Drug|sunitinib malate|Given PO
16333566|NCT00397774|Behavioral|Physical exercise|Physical exercise twice a week for 8 weeks, and best supportive care
16333567|NCT00397774|Other|best supportive care|
16333568|NCT00397761|Drug|capecitabine|
16333569|NCT00397761|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16333570|NCT00397761|Procedure|neoadjuvant therapy|
16333571|NCT00397735|Procedure|amniocentesis|Amniotic fluid will be retrieved for routine amniocentesis to rule-out or confirm intra-amniotic infection and /or inflammation. The amniocentesis procedure will be clinically indicated and the patient will undergo the procedure independent of our study.
16333572|NCT00397735|Drug|N-acetylcysteine or placebo|Only women with amniocentesis results consistent with infection/inflammation will be randomized
16333573|NCT00397722|Drug|GW876008|
16333574|NCT00397722|Drug|paroxetine|
16333575|NCT00397709|Drug|I ( isoniazid), II (isoniazid + rifampin )|
16333576|NCT00397696|Drug|[123I] 5-IA|All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of [123I] 5-IA followed by SPECT imaging as described below. A second [123I] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial [123I] 5IA imaging session.
16333577|NCT00397683|Drug|MK0822|
16333578|NCT00397670|Drug|Drug: BufferGel® with diaphragm|
16333579|NCT00397657|Drug|extended release niacin|Extended release niacin will be started at 1000mg and titrated to 2000mg once a day
16333580|NCT00397657|Drug|ezetimibe|Ezetimibe 10mg once daily
16333581|NCT00397644|Behavioral|Prompting (survey instrument/resources list) (behavior)|
16333582|NCT00397631|Drug|sitagliptin 100 mg q.d./pioglitazone 30 mg q.d|Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
16333583|NCT00397631|Drug|Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.|Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.
16333584|NCT00397605|Drug|Synthetic cannabinoids (1:1 ratio of THC % CBD)|Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.
16333585|NCT00397592|Drug|Growth Hormone|
16333586|NCT00397579|Drug|DT388IL3|Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
16333587|NCT00397566|Drug|HIV Integrase Inhibitor (BMS-707035)|
16333588|NCT00397553|Drug|Insulin glulisine|
16333589|NCT00397540|Procedure|PEIT|Percutaneous Ethanol Injection Therapy
16333590|NCT00397540|Procedure|RFTA|Radiofrequency Thermal Ablation
16333591|NCT00397527|Drug|lactoserum|
16333592|NCT00397514|Procedure|Congenital Heart Surgery Patients|undergoing either Biventricular (BiV) pacing or Right Ventricular (RV) Pacing
16333593|NCT00397501|Biological|trastuzumab|"Trastuzamab, 6mg/kg, within 48 hrs before BBBD
~Then, Trastuzumab, 2mg/kg, weekly until next BBBD Then continue for 12 cycles"
16333594|NCT00397501|Drug|carboplatin|200mg/m2/day x 2 days; total dose 400mg/m2 Infused i.a. over 10 mins in 200ml of normal saline after MTX infusion
16333595|NCT00397501|Drug|methotrexate|2500 mg/day x 2 days; total dose 5000mg Infused over 10mins in 200ml saline beginning immediately after mannitol infusion
16333596|NCT00397501|Drug|sodium thiosulfate|STS dose admin i.v. over 15mins @ 4hrs post carboplatin = 20gm/m2; STS dose admin i.v. over 15mins @ 8hrs post carboplatin = 16gm/m2
16333597|NCT00397488|Drug|sunitinib malate|
16333598|NCT00397475|Drug|Colecalciferol|
16333599|NCT00397462|Device|calf muscle pump stimulation|Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
16333600|NCT00397449|Biological|GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)|
16333601|NCT00397436|Procedure|UV Irradiation|UV irradiation
16333602|NCT00397423|Drug|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor,5ug/kg/day iH Qd*5 days,3 months interval for 4 times
16333603|NCT00397423|Drug|NS|NS 1ml iH Qd*5 days, 3 months interval for 4 times
16333604|NCT00397410|Device|Hip protectors|
16333605|NCT00397384|Drug|cetuximab|Given IV
16333606|NCT00397384|Drug|erlotinib hydrochloride|Given PO
16333607|NCT00397384|Other|laboratory biomarker analysis|Correlative studies
16333608|NCT00397358|Drug|Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution|
16333609|NCT00397345|Biological|Trovax|1ml IM injection 2-8 weeks apart.
16333610|NCT00397345|Biological|Placebo|Placebo
16333611|NCT00397345|Biological|Standard of care therapy|subcutaneous low dose IL-2, interferon-α or sunitinib
16333612|NCT00397332|Drug|Alefacept|IM Alefacept
16333613|NCT00397319|Drug|Growth Hormone|
16333614|NCT00397306|Device|Bioimpedance Analysis|
16333615|NCT00397293|Drug|AT-101|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
16333616|NCT00397293|Drug|topotecan|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
16333617|NCT00397267|Drug|inhalation of corticosteroids|
16333618|NCT00397254|Drug|rizatriptan|10mg ODT 27 tablets
16333619|NCT00397254|Drug|rizatriptan|10mg ODT 9 tablets
16333620|NCT00397241|Drug|Drug: dorzolamide/timolol|
16333621|NCT00397241|Drug|Drug: latanoprost/timolol|
16333622|NCT00397241|Drug|dorzolamide/timolol and latanoprost|
16333623|NCT00397241|Drug|placebo (artificial tears)|
16333624|NCT00397228|Drug|ALTROPANE®|ALTROPANE® SPECT imaging
16333625|NCT00397215|Biological|Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)|intramuscular injection
16333626|NCT00397215|Biological|Fluarix|Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
16333627|NCT00397202|Device|Diva Cup TM|See Detailed Description.
16333628|NCT00397189|Drug|Circadin|Prolonged release melatonin 2 mg
16333629|NCT00397189|Drug|placebo circadin|placebo circadin tablets
16333630|NCT00397176|Drug|desvenlafaxine succinate sustained release (DVS SR)|
16333631|NCT00397163|Procedure|Remote ischemic preconditioning|Blood pressure cuff inflation
16333632|NCT00397163|Procedure|Placebo|Deflated cuff on upper arm and thigh for 20 min
16333633|NCT00397150|Behavioral|Peer-support for exclusive breastfeeding|Counselling to support exclusive breastfeeding up to the age of 6 months of age by the use of peer-counsellors in the local community
16333634|NCT00397137|Procedure|Circular stapled anopexy|Patients receiving stapled anopexy to treat haemorrhoids
16333635|NCT00397137|Procedure|Closed diathermy haemorrhoidectomy|Conventional haemorrhoidectomy as described by Ferguson method
16333636|NCT00397124|Device|PET/CT imaging|
16333637|NCT00397098|Drug|SR58611A|
16333638|NCT00397072|Drug|ZK 219477|
16333639|NCT00397059|Drug|Escitalopram|
16333640|NCT00397046|Drug|neratinib|HKI-272
16333641|NCT00397033|Drug|Paliperidone ER|6mg/day paliperidone er for 6 weeks
16333642|NCT00397033|Drug|Paliperidone ER|12mg/day paliperidone er for 6 weeks
16333643|NCT00397033|Drug|Placebo|Placebo for 6 weeks
16333644|NCT00397020|Drug|divalproex ER|Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml
16333645|NCT00397020|Drug|quetiapine|Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.
16333646|NCT00397007|Behavioral|Biofeedback-based cognitive-behavioural intervention|
16333647|NCT00396994|Device|Low magnitude mechanical stimulation|10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz
16333648|NCT00396994|Device|Sham low magnitude mechanical stimulation|10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform
16333649|NCT00396981|Device|Matrix 2® coils for endovascular aneurysm occlusion|endovascular aneurysm occlusion coil
16333650|NCT00396981|Device|GDC® coils for endovascular aneurysm occlusion|endovascular aneurysm occlusion coil
16333651|NCT00396968|Drug|AMD3100|
16333652|NCT00396968|Procedure|Allogeneic Stem Cell Transplantation|
16333653|NCT00396955|Drug|PLA-695|
16333654|NCT00396929|Drug|local intracoronary dosis of Paclitaxel|
16333655|NCT00396916|Device|PET/CT imaging|
16333656|NCT00396903|Device|catheter|
16333657|NCT00396877|Drug|Clopidogrel (SR25990)|"Form: reconstituted solution using Clopidogrel powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
16333658|NCT00396877|Drug|placebo|"Form: reconstituted solution using matching placebo powder
~Route: oral or enteric
~Frequency: once daily
~Dose: daily dose adjusted for weight"
16333659|NCT00396864|Drug|NPI-0052|NPI-0052 IV injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1 to 10 minutes on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation
16333660|NCT00396851|Drug|Gurmar|
16333661|NCT00396851|Drug|Metformin|
16333662|NCT00396825|Behavioral|Video-based coping skills training with telephone coaching|Subjects will view the 10 modules of Williams LifeSkills Caregiver Video, do Workbook exercises for each module, and receive telephone coaching to enhance their ability to apply the skills taught in each module to caregiver situations.
16333663|NCT00396812|Drug|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
16333664|NCT00396799|Drug|bazedoxifene/conjugated estrogens|
16333665|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe
16333666|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe
16333667|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe
16333668|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe
16333669|NCT00396786|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe
16333670|NCT00396786|Drug|Enoxaparin|Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets
16333671|NCT00396760|Drug|aprotinin or tranexamic acid|
16333672|NCT00396747|Drug|Infliximab, methylprednisolone, methotrexate|
16333673|NCT00396747|Drug|Methotrexate|
16333674|NCT00396747|Drug|Methotrexate + Methylprednisolone|
16333675|NCT00396747|Drug|Methotrexate + Infliximab|
16344457|NCT00309764|Behavioral|Telemedicine|
16333676|NCT00396734|Drug|Provigil (Modafinil)|Increase from 100mg to 400mg during 1 month of treatment
16333677|NCT00396734|Drug|Topamax (Topiramate)|Increase from 25mg to 200mg in one month (double every week)
16333678|NCT00396721|Drug|ACE inhibitor + statin|sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d
16333679|NCT00396721|Drug|Sirolimus (study drug)+ACE inhibitor + statin|enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d
16333680|NCT00396708|Device|myomo e100 neurorobotic elbow brace|
16333681|NCT00396695|Procedure|Blood test|
16333682|NCT00396682|Drug|Cyclophosphamide|150 - 250 - 350 mg
16333683|NCT00396669|Drug|Bupropion|We measure dopamine release at the striatum using 11 C Raclopride at baseline and after smoking a cigarette
16333684|NCT00396669|Drug|Bupropion|Brain imaging after treatment with Bupropion
16333685|NCT00396656|Drug|Atenolol|100 mg tablets orally once a day (od) in the morning.
16333686|NCT00396656|Drug|Hydrochlorothiazide (HCTZ))|12.5 or 25 mg tablets orally once a day (od) in the morning.
16333687|NCT00396656|Drug|Valsartan|80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
16333688|NCT00396643|Drug|Omega 3 fatty acids|The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.
16333689|NCT00396630|Biological|Rotarix|Two-dose oral vaccination.
16333690|NCT00396630|Biological|Placebo|Two-dose oral administration.
16333691|NCT00396617|Device|prothesis voice|The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
16333692|NCT00396617|Procedure|total laryngectomy|The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
16333693|NCT00396604|Drug|indacaterol maleate|
16333694|NCT00396591|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg administered intravenously (IV) once every 2 weeks
16333695|NCT00396578|Drug|aerosolized vancomycin or gentamicin|
16333696|NCT00396565|Drug|ER OROS paliperidone|Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
16333697|NCT00396565|Drug|Placebo|Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
16333698|NCT00396565|Drug|Olanzapine|Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
16333699|NCT00396552|Device|refractory transcranial magnetic stimulation (rTMS)|Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of 25 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.
16333700|NCT00396552|Device|Sham condition|Sham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as HFL and HFR for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those with active stimulation but with minimal direct brain effects. Participants will be unable to see the stimulating coil and therefore will remain blind to the treatment condition.
16333701|NCT00396526|Drug|Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs. oral amoxycillin (20 mg/kg/day) thrice a day for three days.|
16333702|NCT00396513|Drug|Simvastatin|
16333703|NCT00396513|Drug|Simvastatin and Metformin|
16333704|NCT00396513|Drug|Metformin|
16333705|NCT00396500|Drug|Albendazole (400 mg) and/or Vitamin a|
16333706|NCT00396487|Drug|Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat|
16333707|NCT00396474|Other|post GH treatment observational study|Intravenous glucose tolerance test (IVGTT)
16333708|NCT00396461|Drug|MCT/LCT (1:1)|Emulsion based on 20% MCT/LCT (50:50 ratio)
16333709|NCT00396461|Drug|MCT/LCT/omega-3 (5:4:1)|Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.
16333710|NCT00396448|Drug|CP-945,598 Treatment B|Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
16333711|NCT00396448|Drug|CP-945,598 Treatment A|Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
16333712|NCT00396448|Drug|Placebo|Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
16333713|NCT00396435|Drug|Neorecormon|Administration SC one a week in patients randomized in group A Administration SC if Hb below 10.5 g/dl in group B
16333714|NCT00396422|Drug|RWJ-445380|
16333715|NCT00396409|Drug|Depigoid|Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL)
16333716|NCT00396409|Drug|Omalizumab|anti-IgE (Omalizumab) given during the 2006 core study
16333717|NCT00396409|Drug|Placebo|Placebo given during the 2006 core study
16333718|NCT00396396|Drug|Acetylcysteine|
16333719|NCT00396383|Drug|plerixafor|Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.
16333720|NCT00396370|Biological|BCG strain Connaught|Connaught strain Bacillus Calmette-Guerin (BCG), 8-32 x 10^5 CFU vaccine for intradermal administration.
16333757|NCT00396084|Drug|Gatifloxacin|Gatifloxacin 400 mg/day x 7 days.
16333721|NCT00396370|Biological|BCG strain Danish|Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 1.2 X 10^8 colony-forming units (CFU) oral (PO) in 60 mililiters phosphate buffered saline (PBS).
16333722|NCT00396370|Biological|BCG strain Danish|Bacillus Calmette-Guerin (BCG) strain Danish from the Statens Serum Institute (SSI BCG). 2-8 X 10^5 colony-forming units (CFU) intradermal in 100 microliters diluent.
16333723|NCT00396370|Other|Placebo|0.1 mL of sterile Sauton medium for intradermal administration.
16333724|NCT00396370|Other|Placebo|60 mL of sterile phosphate buffered saline (PBS) for oral administration.
16333725|NCT00396357|Drug|Vildagliptin|
16333726|NCT00396357|Drug|metformin|
16333727|NCT00396344|Other|Çontrol|Intravenous saline
16333728|NCT00396344|Drug|Hydrocortisone|Intravenous stress dose of hydrocortisone
16333729|NCT00396344|Drug|Hydrocortisone|Intravenous pharmacologic hydrocortisone
16333730|NCT00396331|Drug|G-CSF plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
16333731|NCT00396318|Drug|tenecteplase|"2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
~Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg)."
16333732|NCT00396305|Drug|Placebo|Sterile phosphate buffered saline solution.
16333733|NCT00396305|Biological|Trivalent Inactivated Influenza|The trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color.
16333734|NCT00396292|Drug|Oral iron tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
16333735|NCT00396292|Drug|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
16333736|NCT00396279|Biological|Denosumab|Administered by subcutaneous injection
16333737|NCT00396279|Dietary Supplement|Calcium/Vitamin D|
16333738|NCT00396266|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
16333739|NCT00396253|Drug|Tenecteplase|2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter.
16333740|NCT00396240|Drug|Rosuvastatin|
16333741|NCT00396240|Procedure|Initiatives to improve compliance|
16333742|NCT00396227|Drug|vildagliptin|vildagliptin as add-on to metformin
16333743|NCT00396227|Drug|thiazolidinedione (TZD)|TZD add-on to metformin
16333744|NCT00396214|Drug|Bifeprunox|52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
16333745|NCT00396214|Drug|Quetiapine|Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
16333746|NCT00396214|Drug|Bifeprunox|52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
16333747|NCT00396201|Drug|G-CSF Plus Plerixafor|Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
16333748|NCT00396175|Drug|MK0906, finasteride / Duration of Treatment : 48 Weeks|
16333749|NCT00396175|Drug|Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks|
16333750|NCT00396162|Drug|probiotic containing L.rhamnosus R0011 strain|500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks
16333751|NCT00396162|Other|Placebo|Placebo pill
16333752|NCT00396149|Biological|Placebo|Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
16333753|NCT00396149|Biological|rBet v 1|Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.
16333754|NCT00396136|Device|Corox OTW Steroid Left Ventricular Lead|This is a registry: no study required interventions necessary.
16333755|NCT00396097|Drug|Genotropin|Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
16333756|NCT00396097|Drug|Genotropin|Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
16333758|NCT00396084|Drug|Isoniazid|Isoniazid 300 mg/day x 7 days.
16333759|NCT00396084|Drug|Levofloxacin|Levofloxacin 1000 mg/day x 7 days.
16333760|NCT00396084|Drug|Linezolid|Linezolid 600 mg/day x 7 days; Linezolid 600 mg every 12 hours x 7 days.
16333761|NCT00396084|Drug|Moxifloxacin|Moxifloxacin 400 mg/day x 7 days.
16333762|NCT00396071|Drug|vildagliptin|vildagliptin 100 mg
16333763|NCT00396071|Drug|Placebo|matching placebo
16333764|NCT00396058|Drug|Methylphenidate|
16333765|NCT00396045|Drug|Revlimid (CC-5013)|
16333766|NCT00396032|Drug|placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
16333767|NCT00396032|Drug|tenecteplase|For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
16333768|NCT00396019|Drug|PEG-Intron|
16333769|NCT00396006|Biological|Alpha1-Proteinase Inhibitor|60 mg/kg, weekly, intravenous infusion
16333770|NCT00395993|Drug|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
16333771|NCT00395993|Drug|Ferrous Sulfate tablets|325 mg tablets TID on Days 0 through Day 42
16333772|NCT00395980|Device|surgical table pressure mat|
16333773|NCT00395967|Drug|G-CSF plus plerixafor|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
16333774|NCT00395941|Drug|Pioglitazone|
16333775|NCT00395941|Drug|Acitretin|Acitretin
16333776|NCT00395915|Drug|aripiprazole|
16333777|NCT00395902|Drug|Sensipar after Post Transplant|
16333778|NCT00395889|Procedure|Rehabilitation including structured exercise training|Rehabilitation of at least 8 weeks, for at least twice/week. This group will also receive the exercise counseling as a part of the rehabilitation program.
16333779|NCT00395889|Procedure|Physical Activity Counseling|Six exercise counseling sessions will be carried out during a 6-month period. This group will only receive the counseling and no formal structured exercise training sessions.
16333780|NCT00395876|Drug|placebo|2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).
16333781|NCT00395876|Drug|tenecteplase|2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).
16333782|NCT00395863|Drug|Multihance|0.5 M at a single injection
16333783|NCT00395863|Drug|Arm 2 - Magnevist|0.5 M Magnevist at a single dose injection
16333784|NCT00395850|Drug|Disulfiram|Disulfiram at 0, 250, 375, or 500 mg/day for 12 weeks
16333785|NCT00395837|Behavioral|Aerobic exercise|
16333786|NCT00395824|Procedure|anticoagulation procedure|
16333787|NCT00395811|Procedure|Bone Marrow Stem Cell Therapy combined CABG|Bone Marrow Stem Cell inject into myocardium
16333788|NCT00395798|Device|Soft or stiff cervical collar(device), neck school(behavior)|
16333789|NCT00395785|Device|Carotid Stent Implantation|
16333790|NCT00395785|Device|Embolic Protection|
16333791|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 20 mg once daily (od) for 12 weeks
16333792|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 30 mg od for 12 weeks
16333793|NCT00395772|Drug|Xarelto (Rivaroxaban, BAY59-7939)|BAY59-7939 40 mg od for 12 weeks
16333794|NCT00395772|Drug|(LMW) Heparin + Vitamin K Antagonist|Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks
16333795|NCT00395759|Drug|Optiva artificial tear by Allergan|
16333796|NCT00395746|Drug|sulfonylurea|SU agent
16333797|NCT00395746|Drug|liraglutide|Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
16333798|NCT00395746|Drug|liraglutide|Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.
16333799|NCT00395733|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
16333800|NCT00395733|Drug|Gadopentate dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
16333801|NCT00395720|Biological|MVA85A (TB vaccine)|Intradermal vaccine
16333802|NCT00395720|Biological|MVA 85A|Intradermal vaccine
16333803|NCT00395707|Drug|Lucentis|0.3mg/0.05 ml or 0.5mg/0.05 ml
16333804|NCT00395707|Drug|Ranibizumab|0.3mg/0.05 ml or 0.5mg/0.05 ml
16333805|NCT00395707|Drug|Ranibizumab (Lucentis)|0.3mg/0.05 ml intravitreally
16333806|NCT00395707|Drug|Ranibizumab (Lucentis)|0.5mg/0.05 ml
16333807|NCT00395694|Drug|lamictal|anti-epileptic drug
16333808|NCT00395681|Drug|Diprivan|Propofol 200 mg versus 350 mg
16333809|NCT00395668|Device|TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz).|
16333810|NCT00395655|Drug|Hydralazine and magnesium valproate administration|
16333811|NCT00395655|Procedure|Core-needle biopsy of the breast|
16333812|NCT00395642|Device|Kronos LV-T, Lumax HF-T|Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis.
16333813|NCT00395629|Drug|Deferasirox (ICL670)|
16333814|NCT00395616|Drug|Botox (drug)|
16333815|NCT00395603|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|
16333816|NCT00395603|Drug|Comparator: atorvastatin / Duration of Treatment: 6 Weeks|
16333817|NCT00395577|Drug|VX-702|
16333818|NCT00395551|Drug|ranibizumab|0.5mg intravitreal injection
16333819|NCT00395538|Drug|PTH 1-34|Given twice daily by subcutaneous
16333820|NCT00395512|Drug|Alogliptin|Alogliptin tablets.
16333821|NCT00395512|Drug|Pioglitazone|Pioglitazone tablets.
16333822|NCT00395512|Drug|Placebo|Matching placebo tablets.
16333823|NCT00395499|Drug|Risperidone|
16333824|NCT00395486|Drug|Rosuvastatin|10mg
16333825|NCT00395486|Drug|Atorvastatin|10mg
16333826|NCT00395473|Drug|MK0653, ezetimibe / Duration of Treatment: 6 Weeks|
16333827|NCT00395460|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)
16333828|NCT00395460|Drug|Magnevist|0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
16333829|NCT00395447|Procedure|Straight-forward Device Replacement|
16333830|NCT00395447|Procedure|Device Replacement with Upgrade|
16333831|NCT00395434|Drug|Combretastatin A4 Phosphate (CA4P)|
16333832|NCT00395434|Drug|Bevacizumab (Avastin)|
16333833|NCT00395421|Drug|NM283 plus Peg-IFNα-2a|200 mg QD 180 µg QW
16333834|NCT00395408|Drug|MK0476, montelukast sodium / Duration of Treatment : 56 Weeks|
16333835|NCT00395408|Drug|Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks|
16333836|NCT00395395|Drug|Oral salmon calcitonin, salmon calcitonin nasal spray|
16333837|NCT00395382|Drug|Alendronate|70mg weekly orally
16333838|NCT00395382|Drug|Placebo|weekly orally
16333839|NCT00395369|Drug|intraoperative aprotinin administration|
16333840|NCT00395356|Behavioral|calorie controlled diet|
16333841|NCT00395343|Drug|sitagliptin phosphate|sitagliptin 100 mg tablet qd for a 24-wk treatment period.
16333842|NCT00395343|Drug|Comparator : placebo (unspecified)|sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.
16333843|NCT00395317|Other|Placebo|placebo tablet
16333844|NCT00395317|Drug|Firategrast 150 mg|150 mg tablet
16333845|NCT00395317|Drug|Firategrast 300 mg|300 mg tablet
16333846|NCT00395304|Drug|fluticasone propionate + montelukast|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
16333847|NCT00395304|Drug|fluticasone propionate|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
16333848|NCT00395304|Drug|fluticasone propionate + salmeterol|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
16333849|NCT00395291|Drug|MK-0677|The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.
16333850|NCT00395291|Drug|Placebo|Placebo
16333851|NCT00395252|Drug|Cetuximab (Erbitux®) and Gemcitabine|"Cetuximab:
~Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks)
~Gemcitabine:
~1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered
~Mode of administration:
~Intravenous infusion"
16333852|NCT00395239|Drug|inhaled corticosteroid|Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
16333853|NCT00395226|Drug|zinc sulfate|zinc sulfate 220 mg bis for 90 days
16333854|NCT00395226|Drug|placebo|placebo bid for 90 days
16333855|NCT00395213|Drug|Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications|Treatment with SSRIs or SNRIs
16333856|NCT00395200|Procedure|MSC Treatment|Intravenous administration of up to 2x10^6 autologous MSCs per kg
16333857|NCT00395187|Procedure|Photodynamic Therapy|
16333858|NCT00395174|Biological|Influenza Vaccination|0.5mL dose for intramuscular injection
16333859|NCT00395161|Drug|Metoclopramide|0.2 mg/kg/dose IV every 12 hours
16333860|NCT00395161|Drug|Zinc|one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants < or equal to one year of age, and 20 mg/day elemental zinc for patients > 1 year of age)
16333861|NCT00395161|Dietary Supplement|Glutamine|one enteral dose daily of glutamine 0.3 gm/kg/day
16333862|NCT00395161|Drug|Selenium|one enteral dose daily of selenium (40 μg for infants < 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children > 13 years)
16333863|NCT00395161|Other|saline|equivalent volume of intravenous saline
16333864|NCT00395161|Other|sterile water|equivalent volume of sterile water
16333865|NCT00395161|Other|selenium|equivalent volume of sterile water
16333866|NCT00395161|Dietary Supplement|whey-protein|one enteral dose daily of whey-protein
16333867|NCT00395148|Drug|rHDL|
16333868|NCT00395135|Drug|Lorcaserin 10 mg BID|Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
16333869|NCT00395135|Drug|Matching Placebo BID|Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
16333870|NCT00395122|Device|Retinal nerve fiber layer and macular thickness measurements|
16333871|NCT00395109|Device|PET/CT|All study participates will be scanned with PET/CT scan before surgery.
16333872|NCT00395083|Behavioral|COPD Self-management Education|The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
16333873|NCT00395070|Biological|Allovectin-7®|Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
16333874|NCT00395070|Drug|Dacarbazine (DTIC)|1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
16333875|NCT00395070|Drug|Temozolomide (TMZ)|150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
16333876|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
16333877|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
16344460|NCT00309738|Drug|pitavastatin|
16333878|NCT00395057|Drug|AGN 211745|AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
16333879|NCT00395057|Drug|Ranibizumab 500µg|Ranibizumab 500µg injections at Day 1, Month 1, Month 2
16333880|NCT00395044|Drug|Placebo|Placebo
16333881|NCT00395044|Drug|Gabapentin|
16333882|NCT00395031|Drug|Ziprasidone|Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
16333883|NCT00395018|Drug|entecavir|Tablets, Oral, 1 mg, once daily, up to 72 weeks
16333884|NCT00394992|Drug|oxaliplatin+capecitabine|postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w
16333885|NCT00394992|Drug|Oxaliplatin+capecitabine+bevacizumab|postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus bevacizumab 7.5 mg/kg on day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w
16333886|NCT00394966|Drug|SCH 619734 Dose 1|SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
16333887|NCT00394966|Drug|SCH 619734 Dose 2|SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
16333888|NCT00394966|Drug|SCH 619734 Dose 3|SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
16333889|NCT00394966|Drug|SCH 619734 Dose 4|SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
16333890|NCT00394966|Drug|Placebo|Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
16333891|NCT00394953|Drug|Darbepoetin alfa|As prescribed, iv.
16333892|NCT00394953|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|120, 200 or 360 micrograms iv / month, starting dose
16333893|NCT00394914|Drug|Pleconaril|Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.
16333894|NCT00394914|Drug|Placebo to Pleconaril|Placebo nasal suspension
16333895|NCT00394901|Drug|Placebo|placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
16333896|NCT00394901|Drug|Pregabalin|Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
16333897|NCT00394901|Drug|Pregabalin|Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
16333898|NCT00394901|Drug|Pregabalin|Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
16333899|NCT00394888|Device|MRI|MRI of the spine.
16333900|NCT00394888|Device|MRI of head and neck|MRI of head and C-spine
16333901|NCT00394888|Other|Dermatological Examination|Complete dermatological examination to identify and characterize nature of dermatological anomalies
16333902|NCT00394888|Other|Cardiac examination|Complete cardiac examination
16333903|NCT00394888|Device|Abdominal ultrasound|Abdominal ultrasound to detect hepatic hemangiomas
16333904|NCT00394875|Procedure|Treated and educated by nurses specialized in diabetes.|
16333905|NCT00394862|Drug|multivitamin|
16333906|NCT00394849|Procedure|suture one tonsillar fossa|one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
16333907|NCT00394836|Drug|Ofatumumab|Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab
16333908|NCT00394836|Drug|Ofatumumab|followed by 7 weekly infusions of 1000mg ofatumumab
16333909|NCT00394823|Behavioral|Set of supportive tools/measures vs. standard care|
16333910|NCT00394810|Drug|Panzem® NCD|suspension, 100 mg/mL, four times daily continuous dosing
16333911|NCT00394797|Procedure|mitral valve annuloplasty|
16333912|NCT00394771|Drug|DR-1031|Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
16333913|NCT00394771|Drug|Seasonale®|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
16333914|NCT00394771|Drug|Portia®|Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
16333915|NCT00394758|Procedure|CO2 laser surgery|
16333916|NCT00394758|Procedure|ultrasonic surgical aspiration|
16333917|NCT00394745|Drug|Valsartan|
16333918|NCT00394732|Device|Total Disc Prosthesis|
16333919|NCT00394732|Behavioral|Multidisciplinary rehabilitation program|
16333920|NCT00394706|Device|Impedance Threshold Device (ITD)|Use of Impedance Threshold Device (ITD)
16333921|NCT00394706|Device|Sham ITD|Sham ITD
16333922|NCT00394706|Other|Analyze early|Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.
16333923|NCT00394706|Other|Analyze later|Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
16333924|NCT00394693|Genetic|Adenovirus Interferon gamma|intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
16333925|NCT00394667|Drug|Tesofensine|
16333926|NCT00394654|Biological|MEDI-528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
16333927|NCT00394654|Other|Placebo|Placebo administered as a single intravenous infusion
16333928|NCT00394641|Behavioral|listening to music / stories via stereophonic headphones|
16333929|NCT00394628|Drug|AQ4N|
16333930|NCT00394628|Drug|Temozolomide|
16333931|NCT00394628|Procedure|Radiotherapy|
16333932|NCT00394615|Procedure|Metabolic Imaging|
16344461|NCT00309738|Drug|simvastatin|
16333933|NCT00394602|Behavioral|Interview|Interview regarding perceptions of side effects that are related to chemoradiation treatment.
16333934|NCT00394602|Other|Questionnaire|3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
16333935|NCT00394589|Drug|Infliximab Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
16333936|NCT00394589|Drug|Infliximab Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks
16333937|NCT00394589|Drug|Infliximab Control|Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
16333938|NCT00394576|Behavioral|Internet-based nutrition module along with usual care|usual care plus Internet-based nutrition module
16333939|NCT00394576|Behavioral|usual care|usual care
16333940|NCT00394563|Drug|RN624 (PF-04383119)|10 mcg/kg
16333941|NCT00394563|Drug|RN624 (PF-04383119)|25 mcg/kg
16333942|NCT00394563|Drug|RN624 (PF-04383119)|50 mcg/kg
16333943|NCT00394563|Drug|RN624 (PF-04383119)|100 mcg/kg
16333944|NCT00394563|Drug|RN624 (PF-04383119)|200 mcg/kg
16333945|NCT00394563|Drug|placebo|
16333946|NCT00394550|Procedure|supraglottoplasty with laser|"Polysomnogram, fiberoptic flexible laryngoscopy, adenotonsillectomy, direct laryngoscopy, bronchoscopy, laser supraglottoplasty, general anesthesia, a proton-pump inhibitor ibuprofen, acetaminophen with codeine without alcohol, or other narcotic containing medication, antibiotic, possible use of other analgesics per anesthesia None of these procedures are new or experimental. Our investigation pertains to a broader use of the laser supraglottoplasty to include children with obstructive sleep apnea and laryngomalacia, as opposed to the more traditional use of laser supraglottoplasty for only severe laryngomalacia in young children"
16333947|NCT00394550|Procedure|supraglottoplasty with laser|laser excision of laryngomalacia (floppy tissue) on one side of the supraglottis
16333948|NCT00394537|Drug|Labetalol 10mg iv|
16333949|NCT00394524|Device|Glucommander|Glucommander is a Computer-guided Intravenous (IV) insulin infusion protocol used for glycemic control in inpatients. This algorithm directs the administration of IV insulin in response to Blood Glucose (BG) measurement at the patient's bedside. In this study, the Glucommander program was loaded into a PalmOne (Zire 31, Tungsten E2 by Palm Inc.) handheld personal digital assistant (PDA) device. During the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing. An alarm prompted the scheduled glucose check. The insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG- 60).
16333950|NCT00394524|Other|Standard insulin infusion algorithm|Standard insulin infusion Algorithm is a standard paper form insulin infusion algorithm. The algorithm is divided into four columns based on empirically determined insulin sensitivity. The first column was for the most insulin-sensitive patients, and the fourth column was for the most insulin resistant patients. The majority of patients are started in the algorithm 1 column. Insulin resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column. The insulin infusion rate was determined by the patient's BG level and was measured hourly until the patient was stable and within the target range. If BG targets were not achieved and the BG had not decreased by at least 60 mg/dL in the preceding hour, the patient was moved to the next column.
16333951|NCT00394511|Procedure|low-LET photon therapy|
16333952|NCT00394498|Drug|Granulocyte Colony Stimulating Factor|
16333953|NCT00394485|Drug|Procaterol|
16333954|NCT00394485|Drug|Tiotropium|
16333955|NCT00394472|Drug|AZD3355|
16333956|NCT00394459|Device|Perifix Epidural Anaesthesia Catheter|Epidural Catheter
16333957|NCT00394459|Device|Perifix Standard|Perifix Standard
16333958|NCT00394459|Device|Perifix New|Perifix New
16333959|NCT00394446|Drug|MPC-6827|2-hour intravenous infusion given once weekly for 3 consecutive weeks on a 28 day cycle
16333960|NCT00394433|Drug|Bevacizumab|
16333961|NCT00394433|Drug|Docetaxel|
16333962|NCT00394433|Drug|Cisplatin|
16333963|NCT00394433|Drug|Irinotecan|
16333964|NCT00394420|Behavioral|Telephone Quitline|
16333965|NCT00394407|Drug|sliding scale regular insulin|SSRI acqhs
16333966|NCT00394407|Drug|glargine basal insulin and glulisine prandial insulin|glargine insulin once a day and glulisine insulin three times a day as long as patient eating
16333967|NCT00394394|Drug|Amiloride 2,5/d or Enalapril/d 10 mg|
16333968|NCT00394381|Procedure|Infusion of autologous CIK cells|Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients
16333969|NCT00394368|Drug|beclomethasone dipropionate plus formoterol fumarate combination|
16333970|NCT00394368|Drug|fluticasone propionate plus salmeterol xinafoate combination|
16333971|NCT00394355|Drug|mometasone furoate dry powder inhaler|400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
16333972|NCT00394355|Drug|mometasone furoate dry powder inhaler|200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
16333973|NCT00394355|Drug|fluticasone propionate hydrofluoroalkane (HFA)|250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year
16333974|NCT00394355|Drug|montelukast|10 mg given once daily in the evening by mouth for 1 year.
16333975|NCT00394329|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
16333976|NCT00394329|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
16333977|NCT00394329|Drug|Albuterol sulfate|Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
16333978|NCT00394316|Drug|Phagocyte Oxidase Subunit Transduced CD34 Hematopoietic Stem Cells|
16333979|NCT00394303|Drug|Intraoperative continuous insulin infusion|Nomogram specified in appendix
16333980|NCT00394303|Other|Control|Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice.
16333981|NCT00394290|Device|Continuous Positive Pressure|Nighttime continuous positive pressure device, to be used every day
16344462|NCT00309725|Drug|galantamine|
16333982|NCT00394277|Drug|peginterferon alfa-2a|180 µg sc weekly for 48 weeks
16333983|NCT00394277|Drug|Ribavirin|1200 mg po daily for 48 weeks
16333984|NCT00394277|Drug|peginterferon alfa-2a|360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
16333985|NCT00394277|Drug|Ribavirin|1400-1600 mg po daily for 48 weeks
16333986|NCT00394264|Procedure|Soft Tissue|
16333987|NCT00394264|Procedure|Myofascial release|
16333988|NCT00394264|Procedure|Counterstrain|
16333989|NCT00394264|Procedure|Muscle energy|
16333990|NCT00394264|Procedure|Sacro-iliac articulation|
16333991|NCT00394264|Procedure|High-velocity, low amplitude|
16333992|NCT00394251|Drug|Adriamycin and Cytoxan (AC)|Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m^2 intravenous, plus Cytoxan 600 mg/m^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).
16333993|NCT00394251|Drug|ABI-007|260 mg/m^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
16333994|NCT00394251|Drug|Taxol|175 mg/m^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
16333995|NCT00394251|Drug|Bevacizumab|10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).
16333996|NCT00394251|Drug|pegfilgrastim|6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.
16333997|NCT00394238|Procedure|Ultrasonographic imaging|
16333998|NCT00394225|Drug|Oxygen|
16333999|NCT00394225|Drug|Helium|
16334000|NCT00394212|Device|Transoral Suturing|suturing of anastomosis
16334001|NCT00394212|Other|Sham Endoscopy|suturing not performed
16334002|NCT00394199|Drug|Fluticasone propionate/Formoterol Fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334003|NCT00394199|Drug|Fluticasone propionate 100|Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334004|NCT00394199|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334005|NCT00394186|Drug|GW427353|
16334006|NCT00394186|Drug|Placebo|
16334007|NCT00394173|Drug|DNK333|DNK333 25mg b.i.d. given orally for 4 weeks
16334008|NCT00394173|Drug|Placebo|Matching placebo
16334009|NCT00394160|Drug|MK0476, Montelukast Sodium /Duration of Treatment : 14 Days|
16334010|NCT00394147|Drug|pemetrexed|pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
16334011|NCT00394147|Drug|gemcitabine|gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
16334012|NCT00394134|Behavioral|Interview|Interviews to describe the sun exposure and sun protection practices of patients and their children.
16334013|NCT00394121|Drug|Fluticasone propionate/formoterol fumarate|
16334014|NCT00394108|Procedure|Determination of neuropsychological status|
16334015|NCT00394095|Drug|Topiramate|Oral topiramate 300-400mg/day for 12 weeks
16334016|NCT00394095|Drug|Placebo|Matched placebo to Experimental arm
16334017|NCT00394082|Drug|ABI-007|125 mg/m^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle.
16334018|NCT00394082|Drug|Bevacizumab|Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.
16334019|NCT00394069|Drug|MK-0476, montelukast sodium|Duration of Treatment: 14 Days
16334020|NCT00394056|Drug|Vestipitant|NK1 receptor antagonist
16334021|NCT00394056|Drug|Vestipitant + Paroxetine|NK1 receptor antagonist and SSRI
16334022|NCT00394056|Other|Placebo|Placebo
16334023|NCT00394043|Procedure|Osteopathic Manipulative Treatment|A protocol of specific Osteopathic manipulative techniques was used.
16334024|NCT00394043|Procedure|Placebo Sub-Therapeutic Ultrasound|Sub-therapeutic ultrasound was applied in a standardized method.
16334025|NCT00394030|Drug|GSK716155 subcutaneous injections|GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
16334026|NCT00394017|Behavioral|Reminder letters|3 mailed reminder letters
16334027|NCT00393991|Drug|Fluticasone propionate/formoterol fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334028|NCT00393991|Drug|Fluticasone propionate 100|Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334029|NCT00393991|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334030|NCT00393991|Drug|Placebo|Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
16334031|NCT00393978|Drug|Quetiapine and placebo|placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).
16334032|NCT00393978|Drug|Quetiapine and Topiramate|topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
16334033|NCT00393965|Drug|MPC-6827|2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.
16334034|NCT00393952|Drug|Fluticasone propionate/Formoterol fumarate 250/10|FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334035|NCT00393952|Drug|Placebo|Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
16334036|NCT00393952|Drug|Fluticasone propionate/Formoterol fumarate 100/10|FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334037|NCT00393952|Drug|Fluticasone propionate 250|Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334038|NCT00393952|Drug|Formoterol fumarate 10|Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
16334039|NCT00393939|Drug|Sunitinib malate|Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
16334040|NCT00393939|Drug|Taxotere|Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
16334041|NCT00393926|Device|TheraDrive Assistive Device|
16334042|NCT00393926|Procedure|Rote Therapy versus Fun Therapy|
16334043|NCT00393913|Device|Continuous Positive Airway Pressure (CPAP)|Positive airway pressure delivered via a nasal mask titrated to a therapeutic level to eliminate all sleep disordered breathing to be used every night for 4-6 weeks.
16334044|NCT00393887|Device|Biodesign IHM|Biodesign IHM is placed to reinforce the hernia repair
16334045|NCT00393887|Device|Polypropylene mesh|Polypropylene mesh is used to reinforce the hernia repair.
16334046|NCT00393874|Behavioral|Behavioral Sleep Intervention|Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, nightmares, and sleep avoidance behaviors. The rationale for imagery rehearsal will then be presented, and the technique will be practiced once. Strategies for managing intrusive thoughts and images during the practice of imagery rehearsal will be discussed. Participants will be instructed to practice this technique at least three times each day for the duration of the treatment phase. During the second 45-minute session (Week 3), sleep schedules extracted from the pre-intervention sleep diary will be used to identify goals to reduce insomnia, i.e., for sleep restricted schedules, and activities to be performed out of bed when awake.
16334047|NCT00393874|Drug|Prazosin|Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal communication, February 4, 2005). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary. Medication will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.
16334048|NCT00393874|Drug|Placebo|Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.
16334049|NCT00393861|Drug|Bevacizumab and Oxaliplatin|Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
16334050|NCT00393848|Drug|Essential amino acid supplement|15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
16334051|NCT00393848|Drug|Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
16334052|NCT00393848|Drug|Placebo|Placebo for Ketoconazole
16334053|NCT00393835|Drug|Azithromycin SR|
16334054|NCT00393822|Drug|palifermin|dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
16334055|NCT00393822|Drug|placebo|one bolus IV injection at 120 μg/kg/day of matched placebo
16334056|NCT00393809|Drug|DTA-H19|
16334057|NCT00393796|Drug|SUTENT|"50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to crossover and receive SU011248."
16334058|NCT00393796|Other|Placebo|
16334059|NCT00393783|Biological|MAB HER 2 (HERCEPTIN)|Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections.
16334060|NCT00393770|Drug|L-acetylcarnitine|250-500 mg/kg/die.
16334061|NCT00393744|Drug|pristinamycin|50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
16334062|NCT00393744|Drug|amoxicillin|50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
16334063|NCT00393731|Drug|Misoprostol|
16334064|NCT00393731|Drug|oxytocin|
16334065|NCT00393718|Drug|liraglutide|0.9 mg/day. Injected s.c. (under the skin) once daily.
16334066|NCT00393718|Drug|glibenclamide|1.25-2.5 mg tablet. Given orally once or twice daily.
16334067|NCT00393718|Drug|placebo|liraglutide placebo. Injected s.c. (under the skin) once daily.
16334068|NCT00393718|Drug|placebo|glibenclamide placebo. Given orally once or twice daily.
16334069|NCT00393705|Drug|Insulin Biphasic Aspart 30/70|Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
16334070|NCT00393705|Drug|insulin lispro LM|Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
16334071|NCT00393705|Drug|insulin lispro MM|Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks
16334072|NCT00393705|Drug|insulin lispro LM|Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
16334073|NCT00393679|Drug|amodiaquine-artesunate (ASAQ)|A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg
16334074|NCT00393679|Drug|dihydroartemisinin-piperaquine (DHAPQ)|DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.
16334075|NCT00393679|Drug|artemether-lumefantrine (AL)|Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.
16334168|NCT00392938|Diagnostic Test|F-18 FDG PET scan|
16334076|NCT00393679|Drug|Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)|"Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate.
~TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008."
16334077|NCT00393653|Procedure|N-of-1 prescription method|
16334078|NCT00393640|Procedure|Early and regular breast milk expression|Breast pump given to be used on regular intervals
16334079|NCT00393627|Behavioral|Sleep Education Program|The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers. The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH. The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings. A written manual is used.
16334080|NCT00393614|Drug|levetiracetam|20 mg pr. kg a day
16334081|NCT00393575|Behavioral|Community Mobilization|The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program.
16334082|NCT00393562|Drug|modafinil|
16334083|NCT00393562|Drug|methylphenidate|
16334084|NCT00393549|Device|NeuroPath|
16334085|NCT00393536|Behavioral|Educational outreach visiting|
16334086|NCT00393523|Biological|Comparator: Modified Process Hepatitis B Vaccine|Single dose 5 µg/0.5ml modified process hepatitis B vaccine
16334087|NCT00393523|Biological|Comparator: Comparator: ENGERIX-B|Single dose 10 µg/0.5ml ENGERIX-B
16334088|NCT00393510|Drug|TCM|"The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
~The formula consisted of 12 herbs, viz:
~Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae"
16334089|NCT00393510|Drug|Placebo|"Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
~The placebo was made with starch and colouring materials."
16334090|NCT00393497|Drug|bevacizumab|Bevacizumab 15 mg/kg IV every 21 days
16334091|NCT00393484|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
16334092|NCT00393484|Drug|Lamivudine Placebo|Capsules, Oral, 0 mg, once daily (0-96 weeks)
16334093|NCT00393484|Drug|Lamivudine|"Capsules, Oral, 100 mg, once daily (0-96 weeks)
~Tablets, Oral, 100 mg, once daily (96-240 weeks)"
16334094|NCT00393484|Drug|Entecavir Placebo|Tablets, Oral, 0 mg, once daily (0-96 weeks)
16334095|NCT00393471|Drug|Etanercept|
16334096|NCT00393458|Drug|Indacaterol|Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16334097|NCT00393458|Drug|Formoterol|Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
16334098|NCT00393458|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
16334099|NCT00393458|Drug|Placebo to formoterol|Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
16334100|NCT00393445|Drug|GLP-1 control|intravenous infusion of GLP-1
16334101|NCT00393445|Drug|GLP-1 and Exendin(9-39) 300|intravenous infusion of exendin(9-39) at 300 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
16334102|NCT00393445|Drug|saline control|intravenous infusion of saline
16334103|NCT00393445|Drug|GLP-1 and Exendin(9-39) 600|intravenous infusion of exendin(9-39) at 600 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
16334104|NCT00393445|Drug|GLP-1 and Exendin(9-39) 900|intravenous infusion of exendin(9-39) at 900 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
16334105|NCT00393445|Drug|GLP-1 and Exendin(9-39) 1200|intravenous infusion of exendin(9-39) at 1200 pmol/kg/min during GLP-1 at 0.3 and 0.9 pmol/kg/min
16334106|NCT00393419|Behavioral|Comprehensive pharmacy care program|
16334107|NCT00393393|Drug|intra-articular injection of Hylan G-F 20|
16334108|NCT00393380|Drug|Parathyroid Hormone (teriparatide)|Day +1: PTH 40 mcg, Day +2: PTH 60 mcg, Day +3: PTH 80 mcg, Day +4 to Day +29 or until ANC>2000/microL: PTH 100 mcg
16334109|NCT00393367|Drug|Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg|Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
16334110|NCT00393367|Drug|Prednisolone, prednisone, or methylprednisolone|All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.
16334164|NCT00392951|Drug|sirolimus|Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)
16334165|NCT00392938|Drug|antiandrogen therapy|
16334166|NCT00392938|Drug|docetaxel|
16334111|NCT00393367|Drug|Albuterol, ipratropium bromide|While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
16334112|NCT00393367|Drug|Ipratropium bromide|500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.
16334113|NCT00393354|Drug|MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|
16334114|NCT00393354|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|
16334115|NCT00393341|Procedure|Blood Draw|Blood sample will be drawn from a vein in the arm.
16334116|NCT00393328|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.
16334117|NCT00393328|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.
16334118|NCT00393315|Device|paclitaxel coated balloon catheter|
16334119|NCT00393302|Procedure|HIV screening in pregnancy|
16334120|NCT00393289|Behavioral|Calcium controlled diet|
16334121|NCT00393276|Biological|Twinrix|Combined hepatitis A and hepatitis B immunization
16334122|NCT00393276|Biological|Decavac|Diphtheria and tetanus toxoid vaccine
16334123|NCT00393263|Drug|pimecrolimus and clobetasol|
16334124|NCT00393263|Drug|clobetasol 0.05% cream|twice daily for three months
16334127|NCT00393211|Drug|MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|
16334128|NCT00393211|Drug|Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|
16334129|NCT00393198|Drug|Levonorgestrel (Mirena, BAY86-5028)|Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
16334130|NCT00393198|Drug|Cytotec|Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
16334131|NCT00393198|Drug|Placebo|Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
16334132|NCT00393185|Biological|Non-myeloablative Hematopoietic Stem Cell Transplantation|autologous Hematopoietic Stem Cell Transplantation
16334133|NCT00393172|Behavioral|exercise|5 days per week exercise for 4 months
16334134|NCT00393159|Device|Ear Popper|
16334135|NCT00393146|Drug|GW856553|Study drug
16334136|NCT00393120|Drug|INCB009471|100mg SR (sustained release) orally once daily
16334137|NCT00393120|Drug|INCB009471|300mg SR (sustained release) orally once daily
16334138|NCT00393120|Drug|Placebo comparator|Orally once daily
16334139|NCT00393107|Drug|rituximab|
16334140|NCT00393107|Drug|rituximab,fludarabine, cyclophosphamide|
16334141|NCT00393094|Biological|Bevacizumab|10 mg/kg intravenous injection
16334142|NCT00393094|Drug|Irinotecan hydrochloride|125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle
16334143|NCT00393068|Drug|Erlotinib|Erlotinib
16334144|NCT00393068|Drug|Bevacizumab|Bevacizumab
16334145|NCT00393068|Drug|Paclitaxel|Paclitaxel
16334146|NCT00393068|Drug|Carboplatin|Carboplatin
16334147|NCT00393068|Drug|5-FU|5-FU
16334148|NCT00393068|Procedure|Radiation therapy|Radiation therapy
16334149|NCT00393068|Procedure|Surgery|Surgery
16334150|NCT00393055|Dietary Supplement|xylitol|1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years
16334151|NCT00393055|Dietary Supplement|inactive lozenge|1g inactive lozenge, dissolved in mouth. Five/day for three years
16334152|NCT00393042|Drug|Dexmethylphenidate|10, 20, 25-30 mg.
16334153|NCT00393042|Drug|Mixed Amphetamine Salts, ER|10, 20, 25-30
16334154|NCT00393042|Drug|placebo|randomized placebo week during each 4 week period
16334155|NCT00393029|Biological|anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes|Peripheral blood lymphocytes are harvested by lymphapheresis and engineered to express a T cell receptor that binds to P53.
16334156|NCT00393029|Biological|aldesleukin|720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days
16334157|NCT00393029|Biological|filgrastim|Beginning on day 1 or 2, administered subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day); continue daily until neutrophil count > 1.0 x 10^9/L x 3 days or > 5.0 x 10^9/L.
16334158|NCT00393029|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenously in 250ml dextrose 5% in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour.
16334159|NCT00393029|Drug|fludarabine phosphate|25 mg/m2/day intravenously piggyback (IVPB) daily over 30 minutes for 5 days.
16334160|NCT00393003|Device|Closed-loop anesthesia system|
16334161|NCT00392990|Drug|Regimen A|Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
16334162|NCT00392990|Drug|Regimen B|Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
16334163|NCT00392977|Dietary Supplement|remove Mn from PN if evidence of increased brain Mn on MRI|trace element cocktail will be withheld and zinc, copper and chromium added to PN individually.
16334167|NCT00392938|Diagnostic Test|C-11 acetate PET scan|
16334169|NCT00392938|Diagnostic Test|Tc-99m bone scan|
16334170|NCT00392938|Diagnostic Test|CT scan of the chest, abdomen and pelvis|
16334171|NCT00392925|Drug|pramlintide acetate 360 mcg|subcutaneous injection, twice a day, 360mcg
16334172|NCT00392925|Drug|metreleptin|subcutaneous injection, twice a day, 5mg
16334173|NCT00392925|Drug|placebo-pramlintide 600 uL|twice a day
16334174|NCT00392925|Drug|placebo-metreleptin 1 mL|twice a day
16334175|NCT00392925|Drug|Pramlintide acetate 180 mcg|subcutaneous injection twice a day, 180 mcg
16334176|NCT00392912|Drug|AndroGel (Solvay Pharmaceuticals)|Testosterone Replacement Therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals). Initial dosage: 5g daily (1 packet). Patients who do not achieve eugonadal levels of 400-600 mg/dL within 2 weeks will be raised to 10g daily.
16334177|NCT00392899|Drug|UFT adjuvant chemotherapy|UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
16334178|NCT00392886|Drug|carboplatin|Given IV
16334179|NCT00392886|Drug|cisplatin|Given IV
16334180|NCT00392886|Drug|cyclophosphamide|Given IV
16334181|NCT00392886|Drug|etoposide|Given IV and orally
16334182|NCT00392886|Drug|methotrexate|Given IV
16334183|NCT00392886|Drug|temozolomide|Given orally
16334184|NCT00392886|Drug|thiotepa|Given IV
16334185|NCT00392886|Drug|vincristine sulfate|Given IV
16334186|NCT00392886|Procedure|autologous bone marrow transplantation|Given on day 0
16334187|NCT00392886|Procedure|autologous hematopoietic stem cell transplantation|Given on day 0
16334188|NCT00392886|Procedure|peripheral blood stem cell transplantation|Given on day 0
16334189|NCT00392886|Radiation|radiation therapy|Some patients undergo radiation therapy once daily, 5 days a week for 4-6 weeks.
16334190|NCT00392873|Behavioral|EAMD+Calories|During the 12 month intervention, volunteers in the Increased calorie intake group will follow a modified dietary plan designed to achieve and maintain a target level of 20-30% above their previously determined baseline, in an effort to achieve a chronic energy surplus of +20-30% over their baseline energy requirements.
16334191|NCT00392860|Device|Natural-Fit|Ergonomic handrim for wheelchairs
16334192|NCT00392860|Device|PalmRim|Ergonomic handrim for wheelchair
16334193|NCT00392860|Device|Handrim Control Group|Participants were given a new standard handrim to test. This intervention group is the control group.
16334194|NCT00392847|Behavioral|Promoting Parental Skills and Enhancing Attachment|The first group will receive routine follow-up as currently provided by national community health and social services.
16334195|NCT00392847|Behavioral|had home visits by community workers during pregnancy|had home visits by community workers during pregnancy to the child's second birthday.
16334196|NCT00392834|Biological|filgrastim|given subcutaneously
16334197|NCT00392834|Biological|pegfilgrastim|given subcutaneously
16334198|NCT00392834|Biological|rituximab|given IV
16334199|NCT00392834|Drug|cyclophosphamide|given IV
16334200|NCT00392834|Drug|cytarabine|given intrathecally
16334201|NCT00392834|Drug|doxorubicin hydrochloride|given IV
16334202|NCT00392834|Drug|etoposide|given IV
16334203|NCT00392834|Drug|ifosfamide|given IV
16334204|NCT00392834|Drug|leucovorin calcium|given IV
16334205|NCT00392834|Drug|liposomal cytarabine|given intrathecally
16334206|NCT00392834|Drug|methotrexate|given intrathecally
16334207|NCT00392834|Drug|therapeutic hydrocortisone|given intrathecally
16334208|NCT00392834|Drug|vincristine sulfate|given IV
16334209|NCT00392821|Drug|Sorafenib|Sorafenib
16334210|NCT00392821|Drug|RAD001|RAD001
16334211|NCT00392808|Biological|conjugated polysaccharide menC vaccine|Booster vaccine dose at 14 to 18 months.
16334212|NCT00392782|Biological|anti-thymocyte globulin|Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines.
16334213|NCT00392782|Drug|fludarabine phosphate|Fludarabine 40 mg/m^2/day intravenously (IV) over 30-60 minutes on days -7,-6,-5,-4,-3 (total dose 200 mg/m^2).
16334214|NCT00392782|Drug|thiotepa|Thiotepa 5 mg/kg/day intravenously (IV) over 4 hours on days -8, -7 (total dose 10 mg/kg).
16334215|NCT00392782|Procedure|peripheral blood stem cell transplantation|Peripheral Blood Stem Cell (PBSC) Infusion. All patients will receive granulocyte colony-stimulating factor (G-CSF)-mobilized PBSC on day 0 (or day+1 when available) following CD34 cell selection for ex vivo T cell removal. PBSC is infused via a central venous catheter using blood infusion tubing.
16334216|NCT00392782|Radiation|total-body irradiation|The total-body irradiation (TBI) will be given in 2 fractions of 400 cGy each administered on day -10 and -9 via anterior and posterior fields for a total dose of 800 cGy.
16334217|NCT00392769|Drug|Cetuximab|Initial Dose = 400 mg/m^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m^2 IV Over 60 Minutes.
16334218|NCT00392756|Drug|gonadotropin releasing hormone (GnRH)|pulsatile GnRH is delivered to adult men (18+ yrs) via portable microinfusion pump. A small dose (30 microliters) is delivered subcutaneously every 120 minutes. The initial dose is 25 ng/Kg which is increased until normal serum testosterone levels are achieved.
16334219|NCT00392743|Procedure|pet/spect scan|
16334220|NCT00392730|Dietary Supplement|Remove Mn from PN if evidence of increased brain Mn on MRI|Withhold Mn-containing trace element cocktail and add zinc, copper and chromium individually to PN
16334221|NCT00392717|Drug|Atorvastatin|
16334222|NCT00392717|Drug|Fish oils|
16334223|NCT00392704|Drug|Bevacizumab|"Induction Treatment:
~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
~Combined Modality Treatment:
~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
16334516|NCT00390624|Drug|MANNITOL|
16334224|NCT00392704|Drug|Erlotinib|"Induction Treatment:
~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
~Combined Modality Treatment:
~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
16334225|NCT00392704|Drug|Paclitaxel|"Neoadjuvant: 200 mg/m2 IV, 1-3 hour infusion, Days 1 and 22
~Combined Modality: 50 mg/m2 IV, 1 hour IV infusion, weekly x6, beginning day 1 of radiation therapy"
16334226|NCT00392704|Drug|5-FU|Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43
16334227|NCT00392704|Radiation|Radiation Therapy|Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
16334228|NCT00392691|Drug|ibritumomab tiuxetan|185 MBq (5mCi) of 111In-Zevalin will be used for radioimaging. and the dose is 14.8 MBq/kg (0.4 mCi/kg) total body weight of 90Y-Zevalin (max. 1184 MBq or 32 mCi at patients > 80kg) for imaging.
16334229|NCT00392691|Drug|rituximab|250 mg/m2
16334230|NCT00392691|Drug|melphalan|"Dose level 1: 100 mg/m2
~Dose level 2: 140 mg/m2
~Dose level 3: 170 mg/m2
~Dose level 4: 200 mg/m2"
16334231|NCT00392691|Drug|vinorelbine tartrate / G-CSF|on day 1: 35 mg/m2 day 4-8 (longer if required) G-CSF 5 μg/kg s.c. morning and 5 μg/kg s.c. evening for at least 5 days
16334232|NCT00392691|Procedure|autologous hematopoietic stem cell harvesting and transplantation|"Optimal mobilization usually takes place on day 8. A minimum of 2.5x106 CD34+ cells/kg should be collected (optimal 5x106 CD34+ cells/kg). If not enough CD34+ cells can be collected on day 8, it is recommended to continue with G-CSF until a sufficient collection (a minimum of 2.5x106 CD34+ cells/kg) can be obtained.
~Stem cells will be reinfused approximately 24 hours after the melphalan administration. The infusion will be performed with a minimum of 2.5x106 CD34+ cells/kg body weight according to local guidelines. G-CSF (5 μg/kg/d) will be given from day 5 and continued until neutrophils > 0.5x109/l for at least 2 consecutive days."
16334233|NCT00392678|Drug|Salsalate|Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
16334234|NCT00392678|Drug|Placebo|Placebo to Salsalate
16334235|NCT00392665|Drug|Bevacizumab|Given intravenously on day one of each 3 week cycle
16334236|NCT00392665|Drug|erlotinib|Given orally once a day
16334237|NCT00392665|Drug|Sulindac|Given orally twice a day
16334238|NCT00392652|Drug|oral microencapsulated diindolylmethane|Given PO
16334239|NCT00392639|Procedure|Comparison of 2 cooling procedures|Comparison of 2 cooling procedures
16334240|NCT00392613|Procedure|Strict versus lenient rate control|
16334241|NCT00392587|Drug|GW856553|
16334242|NCT00392574|Drug|Prulifloxacin|Tablet
16334243|NCT00392574|Drug|Placebo|Tablet
16334244|NCT00392561|Dietary Supplement|Selenium|200 ug Selenium daily
16334245|NCT00392561|Dietary Supplement|vitamin E|100 mg Vitamin E daily
16334246|NCT00392535|Radiation|conventional radiotherapy 74 Gy delivered in 37 fractions|
16334247|NCT00392535|Radiation|hypofractionated radiation therapy 60 Gy in 20 fractions|
16334248|NCT00392535|Radiation|hypofractionated radiation therapy 57 Gy in 19 fractions|
16334249|NCT00392522|Drug|50% Nitrous Oxide and 50% Oxygen (MEOPA)|
16334250|NCT00392509|Procedure|ALDH-br bone marrow cells vs. mononuclear bone marrow cells|Surgery
16334251|NCT00392496|Drug|sunitinib malate|Given orally
16334252|NCT00392470|Biological|cetuximab|
16334253|NCT00392470|Drug|irinotecan hydrochloride|
16334254|NCT00392470|Procedure|conventional surgery|
16334255|NCT00392470|Procedure|neoadjuvant therapy|
16334256|NCT00392470|Radiation|3-dimensional conformal radiation therapy|
16334257|NCT00392470|Radiation|intensity-modulated radiation therapy|
16334258|NCT00392457|Drug|ketoconazole|loading dose of 1g followed by a maintenance dose of 400 mg PO QID for 7 days
16334259|NCT00392457|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)
16334260|NCT00392444|Drug|sunitinib malate|Given orally
16334261|NCT00392431|Drug|amiodarone|
16334262|NCT00392418|Drug|Multiple micronutrient supplement (iron)|
16334263|NCT00392405|Drug|3 amps of sodium bicarbonate mixed in one liter of D5W|
16334264|NCT00392392|Drug|nab-paclitaxel|ABI-007
16334265|NCT00392392|Drug|Bevacizumab|Bevacizumab
16334266|NCT00392392|Drug|Trastuzumab|Trastuzumab
16334267|NCT00392379|Drug|Nicotine Lozenges|Nicotine lozenges, 4 mg
16334268|NCT00392379|Drug|Placebo lozenge|Placebo lozenge
16334269|NCT00392366|Device|MR-guided Laser Interstitial Thermal Therapy System|
16334270|NCT00392353|Drug|Azacitidine|Given SC
16334271|NCT00392353|Other|Laboratory Biomarker Analysis|Correlative studies
16334272|NCT00392353|Other|Pharmacological Study|Correlative studies
16334273|NCT00392353|Drug|Vorinostat|Given PO
16334274|NCT00392340|Biological|filgrastim|
16334275|NCT00392340|Drug|doxorubicin hydrochloride|
16334276|NCT00392340|Drug|topotecan hydrochloride|
16334277|NCT00392340|Drug|vincristine sulfate|
16334278|NCT00392327|Drug|Carboplatin|Given IV
16334279|NCT00392327|Drug|Cisplatin|Given IV
16334280|NCT00392327|Drug|Cyclophosphamide|Given IV
16334281|NCT00392327|Biological|Filgrastim|Given IV or SC
16334282|NCT00392327|Drug|Isotretinoin|Given PO
16334283|NCT00392327|Other|Laboratory Biomarker Analysis|Correlative studies
16334284|NCT00392327|Other|Quality-of-Life Assessment|Ancillary studies
16334285|NCT00392327|Radiation|Radiation Therapy|Undergo radiation therapy
16334286|NCT00392327|Drug|Vincristine Sulfate|Given IV
16334287|NCT00392314|Other|PET/CT post 2 cycles of chemotherapy|sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
16334288|NCT00392288|Drug|Ciclesonide|Ciclesonide MDI 40 µg BID over twelve weeks
16334289|NCT00392288|Drug|Ciclesonide|Ciclesonide MDI 80 µg BID over twelve weeks
16334290|NCT00392288|Drug|Placebo|Placebo MDI over twelve weeks
16334291|NCT00392275|Drug|Ofloxacin 0.3%|
16334292|NCT00392275|Drug|Ciprofloxacin 0.3%|
16334293|NCT00392275|Drug|Levofloxacin 0.5%|
16334294|NCT00392275|Drug|Ofloxacin 400mg|
16334295|NCT00392275|Drug|Ciprofloxacin 400mg|
16334296|NCT00392275|Drug|Levofloxacin 250mg|
16334297|NCT00392262|Drug|valsartan + amlodipine|
16334298|NCT00392249|Behavioral|Supervised Treatment of Schizophrenia by a family member|
16334299|NCT00392236|Device|2-way pager|Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking.
16334300|NCT00392236|Behavioral|Treatment as usual|Participants will receive treatment as usual.
16334301|NCT00392223|Drug|Azithromycin microspheres|Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
16334302|NCT00392223|Drug|minocycline-placebo capsules|minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
16334303|NCT00392223|Drug|Azithromycin microspheres-placebo|Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.
16334304|NCT00392223|Drug|Minocycline capsules,|Capsules, PO, 100 mg daily for 8 weeks.
16334305|NCT00392210|Genetic|Voiding Trial|Post-void residual and uroflow study will be done twice
16334306|NCT00392197|Drug|Aripiprazole|1 or 2 times a day, p.o., 6 - 24mg a day
16334307|NCT00392184|Procedure|Accelerated partial breast irradiation|
16334308|NCT00392171|Drug|Temozolomide|Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
16334309|NCT00392158|Device|Closed-loop anesthesia system|
16334310|NCT00392145|Drug|Standard IV rehydration|A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
16334311|NCT00392145|Drug|Rapid intravenous rehydration (RIVR)|A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
16334312|NCT00392119|Device|MR-guided Laser Interstitial Thermal Therapy System|
16334313|NCT00392106|Drug|propafenone|Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
16334314|NCT00392106|Drug|flecainide|Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
16334315|NCT00392106|Drug|dofetilide|Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
16334316|NCT00392106|Drug|sotolol|Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
16334317|NCT00392106|Device|Pulmonary vein ablation|Electrical isolation of pulmonary vein with high-intensity focused ultrasound
16334318|NCT00392106|Drug|Amiodarone|Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
16334319|NCT00392093|Drug|Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d|
16334320|NCT00392080|Drug|CJ-023,423|75 mg BID
16334321|NCT00392080|Drug|placebo|placebo
16334322|NCT00392080|Drug|naproxen|naproxen
16334323|NCT00392067|Drug|Calcipotriol and LEO80122 (LEO19123 cream)|
16334324|NCT00392054|Procedure|Pulmonary Vein Isolation performed by Catheter Ablation|Ablation will be done to achieve entrance block into all pulmonary veins.
16334325|NCT00392054|Drug|Conventional Antiarrhythmic Drug Therapy|Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF
16334326|NCT00392041|Drug|Eszopiclone|3mg qpm for 12 weeks
16334327|NCT00392041|Drug|placebo|1 pill qpm for 12 weeks
16334328|NCT00392028|Drug|ertapenem|
16334329|NCT00392015|Biological|NMRC-M3V-Ad-PfCA|Malaria Vaccine
16334330|NCT00392015|Biological|NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA|Malaria Vaccines
16334331|NCT00392002|Drug|Esomeprazole|
16334332|NCT00391989|Drug|Dasatinib|
16334333|NCT00391976|Drug|Tobramycin solution for inhalation 300 mg|Tobramycin solution for inhalation was supplied in 5 mL liquid-filled low-density polyethylene ampoules containing 300 mg tobramycin. Patients used a nebulizer to inhale the contents of the ampoules.
16334334|NCT00391963|Device|Bispectral index, Entropy|
16334335|NCT00391950|Drug|Zoledronic acid|
16334336|NCT00391937|Device|Articular Surface Replacement (ASR) hip prosthesis|a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.
16334337|NCT00391924|Drug|Dehydroepiandrosterone|
16334338|NCT00391911|Drug|N-Acetylcysteine|Patients are assigned to either N-Acetylcysteine or placebo. Dose is weight based Placebo is normal saline or D5W
16334339|NCT00391911|Other|N-Acetylcystine and Non CRRT|Patients are assigned to N-Acetylcysteine and CRRT. The N-Acetylcysteine is blinded to everyone except pharmacy. The CRRT is open label as would be impossible to blind
16334340|NCT00391911|Other|Placebo and CRRT|Patients are assigned to Placebo and CRRT. The N-Acetylcysteine/Placebo is blinded to everyone except pharmacy. The CRRT is open label
16334341|NCT00391911|Other|Placebo and Non CRRT|Patients are assigned to Placebo and non-CRRT. The N-Acetylcysteine/placebo is blinded to everyone except pharmacy. The CRRT/non CRRT is open label as would be impossible to blind
16334342|NCT00391898|Drug|Levodopa/carbidopa/entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
16334343|NCT00391898|Drug|Levodopa/carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
16334344|NCT00391885|Device|Closed-loop anesthesia system|
16334345|NCT00391872|Drug|Ticagrelor|Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
16334517|NCT00390611|Drug|Sorafenib|
16334346|NCT00391872|Drug|Clopidogrel|Clopidogrel 75 mg once daily dose (ODD)
16334347|NCT00391859|Procedure|Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)|See Detailed Description.
16334348|NCT00391846|Drug|Captopril|
16334349|NCT00391846|Drug|Enalapril|
16334350|NCT00391846|Drug|Lisinopril|
16334351|NCT00391846|Drug|Ramipril|
16334352|NCT00391846|Drug|Trandolapril|
16334353|NCT00391846|Drug|Bisoprolol|
16334354|NCT00391846|Drug|Carvedilol|
16334355|NCT00391846|Drug|Metoprolol succinate|
16334356|NCT00391846|Drug|Candesartan|
16334357|NCT00391846|Drug|Valsartan|
16334358|NCT00391846|Drug|Eplerenone|
16334359|NCT00391846|Drug|Spironolactone|
16334360|NCT00391846|Drug|Diuretics|
16334361|NCT00391846|Drug|HF treatment according to Swedish guidelines|
16334362|NCT00391846|Procedure|Blood samples|
16334363|NCT00391846|Procedure|The Kansas City Cardiomyopathy Questionnaire (KCCQ)|
16334364|NCT00391833|Drug|Panax Ginseng|
16334365|NCT00391820|Drug|TD-5108|
16334366|NCT00391807|Drug|Norethindrone acetate/ethinyl estradiol|one tablet per day
16334367|NCT00391794|Behavioral|Early Stage Memory Loss Support Group|8 week support group led by trained facilitators
16334368|NCT00391794|Behavioral|Educational Seminar|4 hour education session led by trained facilitators
16334369|NCT00391781|Procedure|Temperature of contrast medium|
16334370|NCT00391768|Drug|oseltamivir (Tamiflu®)|Oseltamivir is supplied as a white powder blend for constitution to a suspension. It is supplied in 100 ml amber glass bottles with 30 grams of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup. Initially subjects in Cohort I received oseltamivir 30 mg orally twice daily for 5 days. The DSMB recommended on 05-Aug-2009 that weight based dosing of oseltamivir for subjects subsequently enrolled in Cohort I. Based on pharmacokinetic data available as of that date, the initial weight-based dose to be evaluated for Cohort I is 3.5 mg/kg twice a day. Cohort II and Cohort III will receive oseltamivir at 3.0 mg/kg/dose orally twice daily for 5 days. Cohorts IV and V will receive 3.0 mg/kg/dose orally twice daily for 5 days, this dose may be adjusted.
16334371|NCT00391755|Drug|ramelteon|"ramelteon 8mg po qhs with sleep and headache diary
~placebo 1 po qhs with sleep and headache diary"
16334372|NCT00391742|Behavioral|Brief intervention|
16334373|NCT00391729|Drug|ABT-089|Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
16334374|NCT00391729|Drug|Placebo|Subjects will take placebo QD, BID for 4-6 weeks
16334375|NCT00391716|Drug|Gabapentin 900mg|900 mg gabapentin daily for 12 weeks
16334376|NCT00391716|Behavioral|behavioral counseling|The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
16334377|NCT00391716|Drug|placebo|lactose capsule compounded to mimic gabapentin capsules
16334378|NCT00391716|Drug|gabapentin 1800mg|1800 mg gabapentin daily for 12 weeks
16334379|NCT00391703|Behavioral|Electrostimulation programme: using a cycloergometer|Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week
16334380|NCT00391703|Behavioral|Usual sport activity|Usual sport activity performed prior to an endurance retraining program using a cycloergometer
16334381|NCT00391690|Drug|Zoledronic acid|In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.
16334382|NCT00391677|Behavioral|Social skills training with attention shaping procedures|Social skills training with attention shaping procedures includes behavioral procedures to increase the frequency, intensity, and duration of attentive behaviors and to reduce the frequency of inattentive behaviors.
16334383|NCT00391677|Behavioral|Social skills training without attention shaping|Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.
16334384|NCT00391664|Behavioral|Psychosocial|
16334385|NCT00391651|Drug|Nitrofurantoin 100mg twice daily x 5 days|Nitrofurantoin 100mg twice daily x 5 days
16334386|NCT00391651|Drug|TMP/SMX DS twice daily x 3 days|TMP/SMX DS twice daily x 3 days
16334387|NCT00391638|Drug|TRUVADA (EMTRICITABINE + TENOFOVIR DF)|Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
16334388|NCT00391638|Biological|PEGASYS 180μg (Interféron pégylé alpha -2a)|Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
16334389|NCT00391625|Drug|GA-GCB|15-60 U/kg every other week via intravenous infusion
16334390|NCT00391612|Device|Exhale® Drug-Eluting Stent|Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours
16334391|NCT00391612|Device|Sham control|5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours
16334392|NCT00391599|Procedure|enema|
16334393|NCT00391586|Drug|Erlotinib|"Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months.
~Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient"
16334394|NCT00391586|Drug|Platinum-based chemotherapy|Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles
16334395|NCT00391573|Procedure|Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery|
16334396|NCT00391573|Procedure|Nylon sutures for suturing of conjunctival autograft in pterygium surgery|
16334397|NCT00391560|Drug|perifosine|Identical intervention in both arms.
16334398|NCT00391547|Drug|Frio Oral Rinse|
16334399|NCT00391534|Drug|modified release formulation of oxcarbazepine (OXC MR)|Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.
16334518|NCT00390611|Drug|Paclitaxel|Paclitaxel
16334400|NCT00391534|Drug|immediate release formulation of oxcarbazepine (OXC IR)|Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.
16334401|NCT00391521|Drug|AS703569|Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
16334402|NCT00391521|Drug|AS703569|Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
16334403|NCT00391521|Drug|AS703569|Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
16334404|NCT00391495|Procedure|Blood drawing|
16334405|NCT00391482|Behavioral|Peer Mentoring Intervention for HCV-Infected IDUs|
16334406|NCT00391469|Other|Rapid infusion of 2 liters of 4oC normal saline|Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
16334407|NCT00391469|Drug|Rapid infusion of cold normal saline|
16334408|NCT00391456|Behavioral|Animal-assisted Therapy|
16334409|NCT00391443|Drug|Bosentan|Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight > 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight < 40 kg)
16334410|NCT00391443|Drug|Placebo|Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
16334411|NCT00391430|Drug|Sertraline|Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
16334412|NCT00391430|Behavioral|Cognitive behavioral therapy (CBT)|CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
16334413|NCT00391417|Drug|estradiol gel|
16334414|NCT00391404|Drug|Alendronate|Alendronate 70 mg weekly (oral)
16334415|NCT00391404|Drug|Placebo|Placebo
16334416|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine|Vaccine (infant dose)
16334417|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine|Vaccine (children dose)
16334418|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)|Vaccine (infant dose)
16334419|NCT00391391|Biological|Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)|Vaccine (children dose)
16334420|NCT00391365|Procedure|Gait analysis|Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras.
16334421|NCT00391352|Drug|IFN-β-1a (Rebif®)|44 mcg Three times a week, subcutaneous injection
16334422|NCT00391339|Drug|Bryophyllum p.|
16334423|NCT00391313|Drug|Chloroquine|
16334424|NCT00391300|Procedure|bioelectric field imaging|
16334425|NCT00391300|Procedure|biopsy|
16334426|NCT00391300|Procedure|histopathologic examination|
16334427|NCT00391274|Drug|pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
16334428|NCT00391274|Drug|docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
16334429|NCT00391261|Drug|Metformin|open-label, flexible dosing
16334430|NCT00391248|Drug|Erlotinib|150 mg in a single daily dose, starting Day 1 through Day 22
16334431|NCT00391222|Drug|Olanzapine|Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily
16334432|NCT00391222|Drug|Placebo|Intramuscular injections of placebo every 2 weeks and oral placebo daily
16334433|NCT00391222|Drug|Risperidone Long Acting Injectable (LAI)|Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily
16334434|NCT00391209|Drug|simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals,6 months
16334435|NCT00391209|Drug|intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 6 months
16334436|NCT00391196|Drug|Placebo|Subjects receive placebo plus non-pharmacological weight loss program.
16334437|NCT00391196|Drug|CP-945,598|Subjects receive CP-945,598 plus non-pharmacological weight loss program.
16334438|NCT00391196|Drug|CP-945,598 Treatment B|Subjects receive CP-945,598 plus non-pharmacological weight loss program.
16334439|NCT00391183|Procedure|Biliary stenting|ERCP and stenting
16334440|NCT00391170|Drug|Topical Dexamethasone|dexamethasone 0.01%
16334441|NCT00391170|Other|Placebo|Placebo
16334442|NCT00391157|Drug|Velcade/Dexamethasone|Velcade 1,3 mg/m2 on days 1, 4, 8 and 11
16334443|NCT00391144|Procedure|intravitreal triamcinolone injection of avastin (1.25 mg)|
16334444|NCT00391131|Drug|IgNextGen 16%|IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
16334445|NCT00391118|Drug|enzastaurin|
16334446|NCT00391118|Drug|carboplatin|
16334447|NCT00391118|Drug|paclitaxel|
16334448|NCT00391118|Drug|placebo|
16334449|NCT00391105|Drug|Remifentanil|
16334450|NCT00391092|Drug|bevacizumab [Avastin]|15mg/kg iv every 3 weeks
16334451|NCT00391092|Drug|Docetaxel|100mg/m2 iv every 3 weeks
16334452|NCT00391092|Drug|Herceptin|8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
16334453|NCT00391079|Drug|Sativex|"Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.
~Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg."
16334454|NCT00391079|Drug|Placebo|Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
16334455|NCT00391066|Drug|FCR + Lumiliximab|Dose, schedule, and duration specified in the protocol
16334456|NCT00391066|Drug|FCR|Dose, schedule, and duration specified in protocol
16334457|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
16334458|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
16334459|NCT00391053|Biological|High-Dose Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
16334460|NCT00391053|Biological|Inactivated, Split-Virion Influenza Vaccine|0.5 mL, IM
16334461|NCT00391040|Behavioral|SGS education|
16334462|NCT00391027|Drug|Insulin Glargine (Lantus®)|Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
16334463|NCT00391027|Drug|Inhaled Human Insulin (Exubera®)|Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
16334464|NCT00391014|Drug|liposomal Amphotericine B|"AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles.
~If patient required ALO-TPH, the prophylaxis should be followed."
16334465|NCT00391001|Drug|Taurine|double-blind, placebo-controlled, adjunctive medication
16334466|NCT00390988|Procedure|blood sampling|
16334467|NCT00390975|Drug|Tegaserod|
16334468|NCT00390949|Behavioral|Peer education among commercial sex workers and clients|
16334469|NCT00390949|Behavioral|Condom distribution and promotion|
16334470|NCT00390949|Procedure|Syndromic treatment of sexually transmitted infections|
16334471|NCT00390949|Procedure|Systemic counselling for STI patients|
16334472|NCT00390936|Drug|Brivanib|Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity
16334473|NCT00390923|Drug|Selegiline + nicotine replacement therapy|Participants will begin selegiline once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
16334474|NCT00390923|Drug|placebo + nicotine replacement therapy|Participants will begin placebo once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
16334475|NCT00390910|Biological|Pneumococcal conjugate vaccine GSK1024850A|Intramuscular injection, 3 doses
16334476|NCT00390910|Biological|Infanrix hexa|Intramuscular injection, 3 doses
16334477|NCT00390897|Drug|Glivec|
16334478|NCT00390897|Drug|Interferon|
16334479|NCT00390884|Biological|Influenza Virus Vaccine, Fluzone®|0.25 mL, Intramuscular
16334480|NCT00390884|Biological|Influenza Virus Vaccine, Fluzone®|0.25 mL, Intramuscular
16334481|NCT00390871|Drug|Fentanyl/Dexmedetomidine|
16334482|NCT00390871|Drug|Fentanyl/Propofol|
16334483|NCT00390871|Drug|Fentanyl|
16334484|NCT00390858|Drug|Deferasirox|Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.
16334485|NCT00390845|Drug|SB681323|15 milligrams (mg)/day
16334486|NCT00390845|Drug|Placebo|
16334487|NCT00390832|Drug|Erythropoietin|33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU
16334488|NCT00390832|Other|Placebo|Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.
16334489|NCT00390806|Drug|HYCAMTIN, oral capsules|topotecan oral capsules 1.1 mg/m2
16334490|NCT00390806|Radiation|Radiation|Whole brain radiation
16334499|NCT00390780|Drug|miconazole Lauriad|50 mg buccal tablet once a day for 14 days
16334500|NCT00390780|Drug|Clotrimazole|10mg troches administered Five Times a Day for 14 days
16334501|NCT00390767|Biological|MultiGeneAngio|Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially
16334502|NCT00390754|Behavioral|Education for pregnancy planning|Provision of free home pregnancy tests to women at risk for unintended pregnancy
16334503|NCT00390741|Behavioral|Exercise Plus Program|Those assigned to the treatment group were visited by an exercise trainer three times a week for the first two months of the study, two times per week during months three and four, one time per week during months five and six, two times a month during months seven and eight, and one time a month during months nine through twelve. During months seven through twelve of the study the trainer contacted the participant by telephone once each week during the weeks that he or she did not go the participants' home.
16334504|NCT00390728|Drug|Insulin Glargine|
16334505|NCT00390715|Drug|chemotherapy|
16334506|NCT00390702|Device|transcatheter implantation of a VSD occluder (Nitinol coil)|transcatheter implantation, by first performing a arterial-venous loop through the defect
16334507|NCT00390689|Drug|Pramipexole 0.125 mg tablet|
16334508|NCT00390689|Drug|Pramipexole 0.5 mg tablet|
16334509|NCT00390676|Drug|ADH -1 and carboplatin|
16334510|NCT00390676|Drug|ADH -1 and docetaxel|
16334511|NCT00390676|Drug|ADH -1 and capecitabine|
16334512|NCT00390663|Procedure|Nasal Cautery|
16334513|NCT00390650|Drug|Saredutant|
16334514|NCT00390637|Behavioral|High or low Glycemic Index and high or low Protein Diet|
16334515|NCT00390624|Drug|URODILATIN (ULARITIDE, ATRIAL NATRIURETIC PEPTIDE)|
16334519|NCT00390611|Drug|Carboplatin|Carboplatin
16334520|NCT00390598|Drug|PEG (solution given 4 L)|
16334521|NCT00390598|Drug|senna glycoside 36 mg and PEG (solution given 2 L)|
16334522|NCT00390585|Drug|Iodixanol 320|Iodixanol 320 is used as contrast media while coronary intervention.
16334523|NCT00390585|Drug|Iomeprol 350|Iomeprol 350 is used as contrast media while coronary intervention.
16334524|NCT00390572|Behavioral|Sleep Specialty Consultation|The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers.
16334525|NCT00390559|Drug|nicotine transdermal system|21 mg nicotine transdermal system
16334526|NCT00390559|Drug|Nicotine transdermal system|Placebo nicotine patch
16334527|NCT00390559|Other|Nicotine containing cigarette|Nicotine containing cigarette
16334528|NCT00390559|Other|Placebo cigarette|Non nicotine containing cigarette
16334529|NCT00390546|Drug|Digoxin|
16334530|NCT00390546|Drug|Propranolol|
16334531|NCT00390533|Drug|Saredutant|oral administration (capsules)
16334532|NCT00390533|Drug|Placebo|oral administration (capsules)
16334533|NCT00390520|Drug|Vildagliptin|
16334534|NCT00390507|Procedure|Post-tetanic count frequency|
16334535|NCT00390494|Procedure|Hysterectomy|
16334536|NCT00390494|Procedure|Myomectomy|
16334537|NCT00390494|Procedure|Uterine Fibroid Embolization|
16334538|NCT00390481|Procedure|EC-IC Bypass in the COSS study|EC-IC Bypass surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull, and then connecting the scalp artery to a brain artery inside the skull. In this way, the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain.
16334539|NCT00390468|Drug|Tandutinib|500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.
16334540|NCT00390455|Drug|Fulvestrant|Given IM
16334541|NCT00390455|Other|Laboratory Biomarker Analysis|Correlative studies
16334542|NCT00390455|Drug|Lapatinib Ditosylate|Given PO
16334543|NCT00390455|Other|Placebo Administration|Given PO
16334544|NCT00390442|Device|continuous positive airway pressure|
16334545|NCT00390429|Drug|docetaxel|Given IV
16334546|NCT00390429|Drug|erlotinib hydrochloride|Given orally
16334547|NCT00390416|Drug|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
16334548|NCT00390403|Drug|R-(-)-gossypol acetic acid|
16334549|NCT00390403|Drug|temozolomide|
16334550|NCT00390403|Genetic|gene expression analysis|
16334551|NCT00390403|Genetic|mutation analysis|
16334552|NCT00390403|Genetic|protein expression analysis|
16334553|NCT00390403|Other|laboratory biomarker analysis|
16334554|NCT00390403|Other|pharmacological study|
16334555|NCT00390403|Procedure|adjuvant therapy|
16334556|NCT00390403|Radiation|radiation therapy|
16334557|NCT00390390|Drug|Lansoprazole|
16334558|NCT00390377|Procedure|Cutting scalp hair|
16334559|NCT00390364|Drug|everolimus|
16334560|NCT00390364|Procedure|antiangiogenesis therapy|
16334561|NCT00390364|Procedure|biopsy|
16334562|NCT00390364|Procedure|diagnostic procedure|
16334563|NCT00390364|Procedure|gene expression analysis|
16334564|NCT00390364|Procedure|immunohistochemistry staining method|
16334565|NCT00390364|Procedure|laboratory biomarker analysis|
16334566|NCT00390364|Procedure|mutation analysis|
16334567|NCT00390364|Procedure|protein tyrosine kinase inhibitor therapy|
16334568|NCT00390364|Procedure|reverse transcriptase-polymerase chain reaction|
16334569|NCT00390351|Device|optical coherence tomography|
16334570|NCT00390338|Biological|polarized dendritic cells|
16334571|NCT00390338|Biological|non-polarized dendritic cells|
16334572|NCT00390325|Drug|Sorafenib Tosylate|Given PO
16334573|NCT00390312|Drug|Intranasal Placebo|Intranasal placebo
16334574|NCT00390312|Drug|Intranasal Morphine 15 mg|Intranasal Morphine 15 mg
16334575|NCT00390312|Drug|Immediate Release Oral Morphine 60 mg|Immediate Release Oral Morphine 60 mg
16334576|NCT00390312|Drug|Intravenous morphine|Intravenous morphine 7.5 mg
16334577|NCT00390312|Drug|Intranasal morphine 7.5 mg|Intranasal morphine 7.5 mg
16334578|NCT00390312|Drug|Oral placebo|Oral placebo
16334579|NCT00390312|Drug|Intravenous placebo|Intravenous placebo
16334580|NCT00390299|Biological|Carcinoembryonic Antigen-Expressing Measles Virus|Given via injection into resection cavity or around tumor bed and/or IT
16334581|NCT00390299|Other|Laboratory Biomarker Analysis|Correlative studies
16334582|NCT00390299|Procedure|Therapeutic Conventional Surgery|Undergo en bloc resection
16334583|NCT00390273|Drug|Metformin|
16334584|NCT00390260|Drug|MK0966 / Duration of Treatment: 1 Days|
16334585|NCT00390260|Drug|Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days|
16334586|NCT00390260|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 1 Days|
16334587|NCT00390247|Drug|thalidomide|
16334588|NCT00390234|Drug|ziv-aflibercept|Given IV
16334589|NCT00390221|Biological|BIIB019 (Daclizumab High Yield Process)|SC injection
16334590|NCT00390221|Drug|Placebo|Placebo SC injection
16334591|NCT00390208|Drug|ranibizumab, dexamethasone and verteporfin|One 500 microgram dose (0.05cc) intravitreal dexamethasone (10 mg/ml vial) in combination with Visudyne Photodynamic Therapy and 0.5 mg intravitreal Ranibizumab injection on the same day.
16334592|NCT00390208|Drug|Ranibizumab|One 0.5 mg intravitreal Ranibizumab injection
16334773|NCT00389155|Other|Placebo|
16334593|NCT00390195|Drug|RAD001 (everolimus)|Arm 1: 2.5, 5, 7.5 or 10 mg of RAD001 daily
16334594|NCT00390195|Drug|RAD001 (everolimus)|Arm 2: 20, 30, 50 or 70 mg of RAD001 daily
16334595|NCT00390182|Drug|Gemcitabine|"Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles.
~Radiation:External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy.
~**Radiation is the experimental part of the study."
16334596|NCT00390169|Behavioral|Mindfulness Meditation-Based Stress Reduction|
16334597|NCT00390169|Behavioral|Supportive-Expressive Group Therapy|
16334598|NCT00390156|Biological|bevacizumab|5 mg/kg
16334599|NCT00390156|Drug|cyclophosphamide|Current dose 50 mg
16334600|NCT00390156|Drug|imatinib|Current dose 400 mg
16334601|NCT00390143|Biological|Meningococcal vaccine 134612|One intramuscular dose during the primary study
16334602|NCT00390143|Biological|Mencevax™ ACWY|One subcutaneous dose during the primary study
16334603|NCT00390130|Drug|Pentacel (DPTaP+Hib)|
16334604|NCT00390130|Drug|Prevnar (conjugated pneumococcal vaccine)|
16334605|NCT00390117|Drug|CDKI AT7519|AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
16334606|NCT00390117|Other|laboratory biomarker analysis|Pharmacokinetic bioanalysis of the AT7519 plasma concentration data will be performed by BioDynamics Northhampton, U.K. The pharmacokinetic parameters for AT7519 will be determined by Astex Therapeutics as data permits.
16334607|NCT00390091|Drug|abetimus sodium (LJP 394)|
16334608|NCT00390078|Biological|MVA-mBN32|3 immunizations: 1x 10E8_TCID50 MVA-mBN32
16334609|NCT00390078|Biological|IMVAMUNE|3 immunizations: 1x 10E8_TCID50 IMVAMUNE
16334610|NCT00390065|Drug|Nitric Oxide|Early low dose (5ppm) NO inhalation Placebo
16334611|NCT00390052|Drug|triapine|Given IV and orally
16334612|NCT00390052|Other|pharmacological study|correlative study
16334613|NCT00390052|Procedure|laboratory biomarker analysis|Correlative study
16334614|NCT00390039|Drug|Intranasal Morphine|MNS075 7.5mg q1h PRN
16334615|NCT00390039|Drug|Placebo|IN Placebo q1h PRN
16334616|NCT00390039|Drug|IV morphine|IV morphine 7.5mg q3h PRN
16334617|NCT00390039|Drug|Placebo|IV Placebo q3h PRN
16334618|NCT00390039|Drug|Intranasal morphine|MNS075 15mg q3h PRN
16334619|NCT00390039|Drug|Placebo|IN Placebo q3h PRN
16334620|NCT00390026|Drug|Bevacizumab (Avastin)|
16334621|NCT00390026|Drug|Verteporfin photodynamic therapy (PDT)|
16334622|NCT00390013|Drug|Gabapentin|"300 mg. capsules
~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
~day 1 you will take 1 capsule for the day
~day 2 you will take 1 capsule 2 times for that day
~days 3-6 you will take 1 capsule 3 times for those days
~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
~days 13-14 you will take 2 capsules 3 times each day
~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
~at completion of study treatment you will titrate off study drug over a weeks time."
16334623|NCT00390013|Drug|Placebo oral capsule|"Placebo capsules
~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
~day 1 you will take 1 capsule for the day
~day 2 you will take 1 capsule 2 times for that day
~days 3-6 you will take 1 capsule 3 times for those days
~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
~days 13-14 you will take 2 capsules 3 times each day
~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
~at completion of study treatment you will titrate off study drug over a weeks time."
16334624|NCT00390000|Drug|vatalanib|Given orally
16334625|NCT00390000|Drug|pemetrexed disodium|Given IV
16334626|NCT00390000|Other|pharmacological study|Correlative study
16334627|NCT00390000|Procedure|ultrasound imaging|Correlative study
16334628|NCT00389987|Drug|MK0826, /Duration of Treatment : 8 Weeks|
16334629|NCT00389987|Drug|Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks|
16334630|NCT00389974|Drug|sunitinib malate|Given PO
16334631|NCT00389948|Drug|Lanzoprazole|
16334632|NCT00389935|Drug|Thalidomide|Thalidomide 50 - 200 mg once at nightime
16334633|NCT00389922|Drug|lapatinib ditosylate|Given orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg)
16334634|NCT00389922|Drug|vinorelbine ditartrate|Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2)
16334635|NCT00389922|Genetic|comparative genomic hybridization|Molecular correlative study
16334636|NCT00389922|Genetic|cytogenetic analysis|Molecular correlative study
16334637|NCT00389922|Genetic|gene expression analysis|Molecular correlative study
16334638|NCT00389922|Genetic|mutation analysis|Molecular correlative study
16334639|NCT00389922|Genetic|polymerase chain reaction|Molecular correlative study
16334640|NCT00389922|Genetic|polymorphism analysis|Molecular correlative study
16334641|NCT00389922|Genetic|proteomic profiling|Molecular correlative study
16334642|NCT00389922|Genetic|reverse transcriptase-polymerase chain reaction|Molecular correlative study
16334643|NCT00389922|Other|immunohistochemistry staining method|Molecular correlative study
16334644|NCT00389922|Other|laboratory biomarker analysis|Molecular correlative study
16334645|NCT00389922|Drug|lapatinib ditosylate|Given orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg)
16334646|NCT00389922|Drug|Vinorelbine ditartrate|Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2)
16334647|NCT00389909|Drug|Doxapram|"Dosing comparison between fixed scheduled and sex related dosage.
~Dosing related to weight only versus chart taking into account weight, age and gender."
16334648|NCT00389896|Drug|MK0733 / Duration of Treatment: 18 Weeks|
16334649|NCT00389896|Drug|Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks|
16334877|NCT00388284|Device|Arterial Sealing|
16334650|NCT00389883|Drug|Comparison of two anesthetics protocol|Comparison of two anesthetics protocol
16334651|NCT00389870|Biological|panitumumab|
16334652|NCT00389870|Drug|cyclosporine|
16334653|NCT00389870|Drug|irinotecan hydrochloride|
16334654|NCT00389857|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (infant/children dose)
16334655|NCT00389857|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (infant/children dose)
16334656|NCT00389844|Behavioral|Exercise Trainer component of the Exercise Plus Program|With the exception of the routine care group, the exercise trainers visited each of the participant in their homes twice a week for two months, once a week for four months, and once a month for six months.
16334657|NCT00389844|Behavioral|Plus component (motivation) of the Exercise Plus Program|Motivation only
16334658|NCT00389844|Behavioral|Exercise Plus Program (exercise + motivation)|Exercise plus motivation
16334659|NCT00389831|Drug|Rotigotine Nasal Spray|Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
16334660|NCT00389831|Other|Placebo Nasal Spray|Daily single dose of placebo delivered as single puff of nasal spray solution
16334661|NCT00389818|Biological|filgrastim|Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
16334662|NCT00389818|Biological|pegfilgrastim|GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
16334663|NCT00389818|Biological|rituximab|375 mg/m2 IV Day 1 of each cycle
16334664|NCT00389818|Biological|sargramostim|GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
16334665|NCT00389818|Drug|cyclophosphamide|750 mg/m2 IV Day 1 of each cycle
16334666|NCT00389818|Drug|pegylated liposomal doxorubicin hydrochloride|40 mg/m2 IV Day 1 of each cycle
16334667|NCT00389818|Drug|prednisone|100 mg PO Days 1-5 of each cycle
16334668|NCT00389818|Drug|vincristine sulfate|1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle
16334669|NCT00389818|Other|immunohistochemistry staining method|tissue specimen collected at baseline
16334670|NCT00389818|Other|laboratory biomarker analysis|tissue specimen collected at baseline
16334671|NCT00389805|Drug|bortezomib|
16334672|NCT00389805|Drug|pemetrexed disodium|
16334673|NCT00389805|Genetic|gene expression analysis|
16334674|NCT00389805|Genetic|mutation analysis|
16334675|NCT00389805|Genetic|protein expression analysis|
16334676|NCT00389805|Genetic|reverse transcriptase-polymerase chain reaction|
16334677|NCT00389805|Other|flow cytometry|
16334678|NCT00389805|Other|immunoenzyme technique|
16334679|NCT00389805|Other|immunohistochemistry staining method|
16334680|NCT00389792|Drug|ATI-2042|no intervention
16334681|NCT00389792|Drug|ATI-2042 200 mg|To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.
16334682|NCT00389779|Drug|Darusentan|Darusentan capsules administered orally once daily
16334683|NCT00389779|Drug|Guanfacine|Guanfacine capsules administered orally once daily
16334684|NCT00389779|Drug|Darusentan Placebo|Placebo to match darusentan administered orally once daily
16334685|NCT00389766|Drug|iodine I 131 metaiodobenzylguanidine|
16334686|NCT00389766|Drug|topotecan hydrochloride|
16334687|NCT00389766|Procedure|chemotherapy|
16334688|NCT00389766|Procedure|peripheral blood stem cell transplantation|
16334689|NCT00389766|Procedure|radioisotope therapy|
16334690|NCT00389766|Procedure|radionuclide imaging|
16334691|NCT00389766|Procedure|radiosensitization|
16334692|NCT00389766|Procedure|total-body irradiation|
16334693|NCT00389753|Drug|Application of Aruba Aloë formula F-BC-096 or control|
16334694|NCT00389740|Drug|MK0217, /Duration of Treatment : 12 Months|
16334695|NCT00389740|Drug|Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months|
16334696|NCT00389727|Drug|Radiotherapy|Radiotherapy
16334697|NCT00389714|Device|dental restoration|
16334698|NCT00389701|Drug|bortezomib|
16334699|NCT00389701|Drug|dexamethasone|
16334700|NCT00389688|Drug|cisplatin|
16334701|NCT00389688|Drug|pemetrexed disodium|
16334702|NCT00389688|Procedure|adjuvant therapy|
16334703|NCT00389688|Procedure|conventional surgery|
16334704|NCT00389688|Procedure|neoadjuvant therapy|
16334705|NCT00389675|Drug|Darusentan|Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
16334706|NCT00389675|Drug|Guanfacine|Guanfacine 1 mg capsules administered orally once daily
16334707|NCT00389662|Device|"Wearing the Nike Free shoe"|
16334708|NCT00389649|Device|heart rate setting|
16334709|NCT00389636|Device|TheraGauze|TheraGauze
16334710|NCT00389636|Drug|Regranex|Regranex + TheraGauze
16334711|NCT00389610|Biological|allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine|Given subcutaneously
16334712|NCT00389597|Device|Cervical Artificial Disc|Cervical artificial disc mechanical device
16334713|NCT00389584|Drug|irinotecan hydrochloride|
16334714|NCT00389584|Procedure|cognitive assessment|
16334715|NCT00389584|Procedure|management of therapy complications|
16334716|NCT00389584|Radiation|radiation therapy|
16334717|NCT00389558|Procedure|disinfection efficacy using Biseptine|Detersion and antiseptic application when changing catheter dressing
16334718|NCT00389558|Procedure|disinfection efficacy using Amukin|Detersion and antiseptic application when changing catheter dressing
16334719|NCT00389545|Procedure|Intracoronary infusion of autologous bone-marrow derived stem cells|
16334720|NCT00389532|Biological|Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)|Influenza vaccine
16334721|NCT00389532|Biological|Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)|Influenza vaccine
16334722|NCT00389519|Drug|ramipril|once a day oral ramipril capsules given for 4 weeks
16345027|NCT00305201|Drug|pravastatin|
16334723|NCT00389519|Drug|placebo|once a day oral placebo capsule for 4 weeks
16334724|NCT00389506|Biological|LMB-2 immunotoxin|
16334725|NCT00389506|Drug|cyclophosphamide|
16334726|NCT00389506|Drug|fludarabine phosphate|
16334727|NCT00389506|Other|pharmacological study|
16334728|NCT00389493|Drug|Risperidone|Dosage of 0.5 mg to 4.0 mg per day as tolerated
16334729|NCT00389493|Behavioral|Exposure/ritual prevention therapy (EX/RP)|EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.
16334730|NCT00389493|Drug|Placebo|Placebo capsules will be identical in appearance to those of risperidone.
16334731|NCT00389480|Drug|AR-67 (formerly DB-67)|infusion daily x 5 days, every 21 days
16334732|NCT00389467|Device|Merci Retriever and Penumbra System|"The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Retriever consists of a flexible, nickel titanium (nitinol) wire with a helical-shaped distal tip. The helical distal tip is covered with a platinum radiopaque coil, which facilitates fluoroscopic visualization. The body of the MERCI Retriever is covered with a hydrophilic coating that helps facilitate device placement. The MERCI Retriever is available in 6 configurations (Merci Retrievers X6, L5, L4, L6, V series, DAC).
~The Penumbra System uses a reperfusion catheter in parallel with a separator component and an aspiration source to achieve separation of the thrombus and subsequent aspiration of the occlusion from the vessel. The system is available in different sizes according to the target vessels (041 Reperfusion Catheter/Separator pair for use in vessels larger than 3mm, notably the ICA and M1; 032 Reperfusion Catheter/Separator pair for use in vessels 2mm - 3mm, notably the M2)."
16334733|NCT00389441|Drug|AG-013736|AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
16334734|NCT00389428|Drug|CPX-351 (Cytarabine:Daunorubicin) Liposome Injection|
16334735|NCT00389415|Drug|Vildagliptin|
16334736|NCT00389402|Drug|saquinavir/ritonavir|
16334737|NCT00389402|Drug|atazanavir/ritonavir|
16334738|NCT00389389|Drug|AZD4877|intravenous infusion
16334739|NCT00389376|Drug|Placebo|Placebo
16334740|NCT00389376|Drug|Silymarin|140 mg every 8 hours
16334741|NCT00389376|Drug|Silymarin|280 mg single dose
16334742|NCT00389376|Drug|Silymarin|280 mg single dose + every 8 hours
16334743|NCT00389376|Drug|Silymarin|560 mg single dose + every 8 hours
16334744|NCT00389376|Drug|Silymarin|560 mg single dose + every 8 hours
16334745|NCT00389376|Drug|Silymarin|280 mg every 8 hours
16334746|NCT00389376|Drug|Silymarin|700 mg single dose + every 8 hours
16334747|NCT00389363|Drug|ALK HDM tablet|
16334748|NCT00389350|Drug|Extract of Green and Black Tea|
16334749|NCT00389324|Biological|Immune Globulin Intravenous (Human)|This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
16334750|NCT00389311|Drug|Normosol-R|
16334751|NCT00389311|Drug|Nonoxynol-9|
16334752|NCT00389311|Procedure|Gastrointestinal instrumentation|
16334753|NCT00389298|Drug|VCH-759 (BCH-27759)|
16334754|NCT00389285|Drug|rIL-21 only|Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
16334755|NCT00389285|Drug|rIL-21 + sorafenib|Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)
16334756|NCT00389272|Drug|Ibuprofen, acetaminophen|
16334757|NCT00389259|Drug|Placebo|IV placebo q4h
16334758|NCT00389246|Behavioral|Consultation without genetic information|
16334759|NCT00389246|Behavioral|Consultation with genetic information|
16334760|NCT00389233|Drug|Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate|"1 pack will consist of 2L NRL 994 - 4 (2 x PEG + E/P + 2 x Vitamin C/C) sachets for the 2L of 2 sachets (1 x P plus 1 x C) will be dissolved in 1L of water. Each litre will be drunk within 1 hour followed by at least 500ml of any additional clear fluid."
16334761|NCT00389233|Drug|Macrogol3350 Na sulphate Na bicarbonate NaCl KCl|"1 pack will consist of 4L PEG + E - contains 4 sachets for the 4L of PEG + E/P/E. Each sachet will be dissolved in 1L of water. Each litre will be drunk within 1 hour."
16334762|NCT00389220|Device|Coronary stent placement|Coronary stent placement
16334763|NCT00389207|Drug|nevirapine bid|nevirapine twice daily
16334764|NCT00389207|Drug|nevirapine qd|nevirapine once daily
16334765|NCT00389207|Drug|atazanavir|atazanavir once daily
16334766|NCT00389194|Drug|continuing AZT+3TC or switching AZT+3TC to TDF+ FTC|
16334767|NCT00389181|Procedure|Interventional therapy|All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.
16334768|NCT00389181|Other|Medical management|Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.
16334769|NCT00389168|Drug|Irbesartan|Titrated to 300 mg od, 48 weeks.
16334770|NCT00389168|Drug|Atenolol|Titrated to 100 mg od, 48 weeks.
16334771|NCT00389155|Drug|Vinflunine|solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
16334772|NCT00389155|Drug|Gemcitabine|solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
16334774|NCT00389129|Drug|acetylsalicylic acid|
16334775|NCT00389116|Drug|gastrograffin|ingestion
16334776|NCT00389116|Drug|water|oral water ingestion
16334777|NCT00389103|Biological|MVA (smallpox vaccine)|0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
16334778|NCT00389090|Drug|Temozolomide and O6-Benzylguanine|O6BG + Temozolomide
16334779|NCT00389077|Drug|Perifosine|Perifosine 50 mg tablets
16334780|NCT00389064|Drug|Quetiapine XR|Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.
16334781|NCT00389064|Drug|Placebo|Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
16334782|NCT00389051|Drug|bendamustine hydrochloride|1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
16334783|NCT00389038|Behavioral|Coping Skills Training|Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
16334784|NCT00389038|Behavioral|Headache Education|Behavioral Treatment 2 (headache education)
16334785|NCT00389038|Drug|Amitriptyline|Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care.
16334786|NCT00389025|Drug|Olopatadine (generic name)|
16334787|NCT00389012|Procedure|exercise therapy|
16334788|NCT00389012|Procedure|walking rehabilitation|
16334789|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16334790|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16334791|NCT00388999|Drug|Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)|Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
16334792|NCT00388986|Drug|GK Activator (2)|100mg po bid
16334793|NCT00388986|Drug|Glyburide|10-20mg po daily
16334794|NCT00388973|Drug|Quetiapine|
16334795|NCT00388960|Drug|Amrubicin|"Amrubicin 45mg/m<2> IV days 1, 2 3 of each 21-day cycle until disease progression.
~Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression."
16334796|NCT00388960|Drug|Cisplatin|"Amrubicin 40mg/m<2> IV days 1, 2, 3 plus Cisplatin 60mg/m<2> day 1 of each 21-day cycle until disease progression.
~Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression."
16334797|NCT00388960|Drug|Etoposide|Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
16334798|NCT00388947|Device|AMS Prolapse Product|AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family
16334799|NCT00388934|Device|Drug eluting stent|percutaneous intervention with implantation of drug eluting coronary stent
16334800|NCT00388921|Drug|Vitamin A|
16334801|NCT00388908|Behavioral|Reminders and opinion leader generated guidelines +/- leaflets and counselling|
16334802|NCT00388908|Other|Usual Care|
16334803|NCT00388895|Drug|chemotherapy|
16334804|NCT00388895|Drug|Glivec|
16334805|NCT00388882|Drug|tiotropium|
16334806|NCT00388882|Drug|ipratropium bromide / albuterol|
16334807|NCT00388856|Drug|Vitamin C 1000mg and E 400IU|
16334808|NCT00388830|Procedure|Ultrasound|
16334809|NCT00388817|Behavioral|Pharmacist intervention|
16334810|NCT00388804|Procedure|Radiation Therapy|Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.
16334811|NCT00388804|Drug|Bicalutamide|50 mg By Mouth (PO) Daily
16334812|NCT00388804|Drug|Leuprolide|22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month
16334813|NCT00388804|Drug|Goserelin|10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month
16334814|NCT00388804|Drug|Flutamide|250 mg by mouth three times daily on first 21-30 Days. May be used instead of Bicalutamide.
16334815|NCT00388804|Behavioral|Questionnaire|Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
16334816|NCT00388791|Drug|Systane Free|
16334817|NCT00388778|Drug|Doxycycline|
16334818|NCT00388752|Procedure|Acupuncture|
16334819|NCT00388739|Drug|Intervention: Budesonide|Patients 1-5 years of age who are randomly assigned to the treatment arm will be given a one month supply as well as a prescription (for a 6 month supply) for Pulmicort respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).
16334820|NCT00388739|Drug|Usual care: albuterol + systemic steroids|All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.
16334821|NCT00388726|Drug|E7389|1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
16334822|NCT00388726|Drug|Physician's Choice|Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.
16346076|NCT00296933|Drug|Escitalopram|
16334823|NCT00388713|Procedure|carotid intima-media thickening ultrasound|
16334824|NCT00388700|Drug|GM-CT-01|On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
16334825|NCT00388700|Drug|5-Fluorouracil, Leukovorin, bevacizumab|On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.
16334826|NCT00388687|Drug|18F Fluoroazomycin Arabinoside (FAZA)|
16334827|NCT00388674|Drug|entecavir|Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
16334828|NCT00388674|Drug|Other anti-HBV medication|Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
16334829|NCT00388661|Drug|Melatonin tablet 3 mg once daily|Melatonin tablet 3 mg once daily
16334830|NCT00388661|Drug|Placebo comparator|Placebo comparator
16334831|NCT00388648|Drug|mixture of amino and keto acids|
16334832|NCT00388635|Drug|Velcade|Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
16334833|NCT00388635|Drug|Melphalan|Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
16334834|NCT00388635|Drug|Prednisone|Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)
16334835|NCT00388622|Behavioral|Pharmacist intervention|
16334836|NCT00388609|Drug|BMS-646256|Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
16334837|NCT00388609|Drug|Placebo|Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
16334838|NCT00388596|Drug|SB-751689|
16334839|NCT00388583|Biological|Split, Inactivated, Trivalent Influenza Vaccine|0.1 mL, Intradermal
16334840|NCT00388583|Biological|Split, Inactivated, Trivalent Influenza Vaccine|0.5 mL, Intramuscular
16334841|NCT00388570|Device|The Aerocrine NIOX MINO® Airway Inflammation Monitor|
16334842|NCT00388557|Drug|vinflunine + ketaconazole|vinflunine solution for injection, ketaconazole tablets, vinflunine IV, ketaconazole oral, vinflunine 80 to 320mg/m2 + ketaconazole 400 mg, vinflunine every 3 wks, ketaconazole C1 only, variable duration
16334843|NCT00388544|Behavioral|Activity matched to interest|Recreational activities are tailored to subject's style of interest
16334844|NCT00388544|Behavioral|Activity matched to function|Recreational activities are tailored to subjects physical and cognitive functioning
16334845|NCT00388544|Behavioral|Activity matched to both interest and function|Recreational activities are tailored to both style of interest and physical and cognitive functioning.
16334846|NCT00388531|Drug|Depocyte®|Depocyte® is a cytostatic drug
16334847|NCT00388518|Drug|Actos|45mg po daily
16334848|NCT00388518|Drug|Placebo|po daily
16334849|NCT00388518|Drug|aleglitazar|Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
16334850|NCT00388505|Drug|Tobramycin Inhalation Powder|Tobramycin Inhalation Powder (TIP) capsules for inhalation.
16334851|NCT00388505|Drug|Tobramycin Solution for Inhalation|Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
16334852|NCT00388479|Drug|Alvimopan|
16334853|NCT00388466|Device|GALILEO|
16334854|NCT00388453|Device|Dx-pH Probe|24 hour ph monitoring
16334855|NCT00388453|Procedure|Manometry|procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
16334856|NCT00388440|Biological|MMR vaccine (Priorix)|
16334857|NCT00388427|Drug|Dasatinib (BMS-354825)|100 mg, 150 mg, or 200 mg per dose escalation schedule; continuous oral dosing on Days 1-21 of each 21-day cycle until progression or unacceptable toxicity develops.
16334858|NCT00388427|Drug|Cetuximab (Erbitux, C225)|Loading dose of IV 400 mg/m^2 on Day 1 of Cycle 1; IV 250 mg/m^2 weekly thereafter each 21-day cycle until progression or unacceptable toxicity develops.
16334859|NCT00388414|Drug|duloxetine|30-60mg of duloxetine daily
16334860|NCT00388414|Drug|Placebo|Placebo pill once daily
16334861|NCT00388401|Drug|Alvimopan|
16334862|NCT00388388|Drug|losartan, hydrochlorothiazide|Losartan, 50-100 mg per day, once a day, for 6 months. Hydrochlorothiazide, 12.5-25 mg per day, once a day, for 6 months.
16334863|NCT00388375|Procedure|Ultrasound|limited ultrasound examination to evaluate the following areas: Examination of the subclavian and internal jugular veins to assess proper catheter placement PTX detection, using lung sliding and comet-tail artifact Visualization of the heart (right atrium and ventricle) and the inferior vena cava through the subcostal window
16334864|NCT00388362|Drug|Sirolimus|Patients will receive sirolimus at 2 mg/day orally with monitoring of trough drug levels weekly for 2 weeks to achieve trough drug levels 7-12 ng/ml. Along with prednisone therapy.
16334865|NCT00388362|Drug|Prednisone|Prednisone therapy will remain at the dose the patient received at the time sirolimus was begun. Withdrawal of prednisone will began after first evidence of improvement of chronic GVHD.
16334866|NCT00388349|Drug|Gemcitabine|
16334867|NCT00388349|Drug|Vinorelbine|
16334868|NCT00388349|Drug|Carmustine|
16334869|NCT00388349|Drug|Etoposide|
16334870|NCT00388349|Drug|Cyclophosphamide|
16334871|NCT00388349|Procedure|Autologous HCT|
16334872|NCT00388336|Drug|Epoetin Alfa|
16334873|NCT00388323|Other|blood and biopsies|blood and biopsies
16334874|NCT00388310|Procedure|Culture|Culture
16334875|NCT00388297|Drug|Levothyroxine|Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
16334876|NCT00388297|Drug|Placebo for Levothyroxine|
16334878|NCT00388271|Drug|Alfuzosin (Xatral)|standard treatment plus alfuzosin
16334879|NCT00388271|Drug|standard treatment|standard treatment
16334880|NCT00388258|Drug|Alvimopan|
16334881|NCT00388245|Procedure|Percutaneous Coronary Intervention|
16334882|NCT00388245|Procedure|Coronary Artery Bypass Grafting|
16334883|NCT00388219|Drug|Transtec (R) PRO (buprenorphine)|
16334884|NCT00388193|Drug|RITUXIMAB|375 mg/m2/d day 1
16334885|NCT00388180|Drug|GW501516|
16334886|NCT00388180|Drug|GW590735|
16334887|NCT00388167|Drug|Caspofungin|The patients are treated with 70 mg IV of caspofungin on day 1, followed by 50 mg/day IV during the rest of treatment
16334888|NCT00388154|Drug|Gemcitabine|900 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
16334889|NCT00388154|Drug|Cisplatin|30 mg/m^2 by vein over 1 hour on Day 1 and Day 8.
16334890|NCT00388141|Behavioral|NIDCAP|Systematic care, where the mother and the nurses organize the caring on behalf of the preterm infants' ressources and developmental capacity such as the infant avoid over stimulation and distress
16334891|NCT00388128|Drug|Caffeine 6mg/kg|Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing
16334892|NCT00388115|Procedure|conventional surgery|Standard of care lumpectomy or mastectomy following RFA
16334893|NCT00388115|Procedure|neoadjuvant therapy|Standard of care lumpectomy or mastectomy following RFA
16334894|NCT00388115|Procedure|radiofrequency ablation|A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current. Initial power of the RF generator will start at 5-10 watts. The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
16334895|NCT00388089|Drug|bortezomib|Dose level A: 1 mg/m2; Dose level B: 1.3 mg/m2; Dose level C: 1.6 mg/m2; Dose level D: 1.6 mg/m2
16334896|NCT00388089|Drug|topotecan hydrochloride|Dose level A: 3 mg/m2; Dose level B: 3 mg/m2; Dose level C: 3 mg/m2; Dose level D: 4 mg/m2
16334897|NCT00388089|Other|flow cytometry|No description
16334898|NCT00388089|Other|immunoenzyme technique|No description
16334899|NCT00388089|Other|immunohistochemistry staining method|No description
16334900|NCT00388089|Other|laboratory biomarker analysis|No description
16334901|NCT00388076|Drug|Pazopanib|pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3
16334902|NCT00388076|Drug|Lapatinib|Lapatinib in combination with pazopanib and paclitaxel in Part 3
16334903|NCT00388076|Drug|paclitaxel|in combination with pazopanib
16334904|NCT00388076|Drug|carboplatin|in combination with pazopanib
16334905|NCT00388063|Drug|Atiprimod|oral, 14 days on / 14 days off; 30mg capsules
16334906|NCT00388050|Behavioral|Diabetes Medication Choice decision aid|The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
16334907|NCT00388050|Behavioral|Usual Care|Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
16334908|NCT00388037|Drug|sunitinib malate|Given PO
16334909|NCT00388037|Other|laboratory biomarker analysis|Correlative studies
16334910|NCT00388011|Drug|Intranasal Morphine (MNS075) 3.75 mg|Intranasal Morphine (MNS075) 3.75 mg
16334911|NCT00388011|Drug|Intravenous Morphine 7.5 mg|Intravenous Morphine 7.5 mg
16334912|NCT00388011|Drug|Intranasal morphine (MNS075) 7.5 mg|Intranasal morphine (MNS075) 7.5 mg
16334913|NCT00388011|Drug|Intranasal morphine (MNS075) 15 mg|Intranasal morphine (MNS075) 15 mg
16334914|NCT00388011|Drug|Intranasal morphine (MNS075) 30 mg|Intranasal morphine (MNS075) 30 mg
16334915|NCT00388011|Drug|Intranasal placebo|Intranasal placebo
16334916|NCT00387998|Other|AHRQ staying healthy booklet|educational booklet about prevention
16334917|NCT00387998|Other|Risk primer|Know your chances booklet
16334918|NCT00387985|Drug|MOA-728|
16334919|NCT00387972|Drug|denagliptin (GW823093)|
16334920|NCT00387959|Biological|filgrastim|
16334921|NCT00387959|Biological|rituximab|
16334922|NCT00387959|Drug|cyclophosphamide|
16334923|NCT00387959|Drug|cyclosporine|
16334924|NCT00387959|Drug|fludarabine phosphate|
16334925|NCT00387959|Drug|mycophenolate mofetil|
16334926|NCT00387959|Procedure|allogeneic hematopoietic stem cell transplantation|
16334927|NCT00387959|Procedure|umbilical cord blood transplantation|
16334928|NCT00387959|Radiation|total-body irradiation|
16334929|NCT00387946|Drug|SSR591813L (dianicline)|
16334930|NCT00387933|Drug|hydroxyurea|
16334931|NCT00387933|Drug|imatinib mesylate|
16334932|NCT00387933|Drug|vatalanib|
16334933|NCT00387920|Drug|sunitinib malate|Given orally
16334934|NCT00387920|Other|pharmacological study|Correlative studies
16334935|NCT00387920|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16334936|NCT00387920|Other|laboratory biomarker analysis|Correlative studies
16334937|NCT00387907|Drug|larotaxel (XRP9881)|administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
16334938|NCT00387907|Drug|trastuzumab|administered as a 90-minute IV infusion on Day 1 of every week (qw)
16334939|NCT00387894|Drug|erlotinib hydrochloride|Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
16334940|NCT00387881|Drug|sumatriptan succinate / naproxen sodium|sumatriptan 85mg / naproxen sodium 500mg
16334941|NCT00387881|Drug|Placebo|Placebo to match Treximet tablets
16334942|NCT00387868|Drug|cisplatin and etoposide|Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33
16334943|NCT00387868|Procedure|Surgical Resection|Resection will take place 4-8 weeks after completion of radiotherapy.
16334944|NCT00387868|Radiation|Concurrent Radiotherapy|Preoperative External Beam Radiotherapy
16334945|NCT00387855|Behavioral|SOS program|screening and didactic programming to raise awareness of depression suicidality
16334946|NCT00387842|Procedure|Laparoscopic surgery|
16334947|NCT00387842|Procedure|Conventional surgery|
16334948|NCT00387829|Device|DuraGen Plus Adhesion Barrier Matrix|Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
16334949|NCT00387803|Device|Cardiac Resynchronization Therapy with Defibrillation|
16334950|NCT00387790|Drug|motexafin gadolinium|Given IV
16334951|NCT00387790|Radiation|3-dimensional conformal radiation therapy|Undergo focal cranial radiotherapy
16334952|NCT00387777|Drug|Patch with centrally acting analgesic|
16334953|NCT00387777|Drug|Transtec(R) PRO (buprenorphine)|
16334954|NCT00387764|Drug|pazopanib|800 mg daily dosing continously until progression
16334955|NCT00387751|Biological|Bevacizumab|Given IV
16334956|NCT00387751|Other|Laboratory Biomarker Analysis|Correlative studies
16334957|NCT00387751|Other|Pharmacological Study|Correlative studies
16334958|NCT00387751|Drug|Sorafenib Tosylate|Given orally
16334959|NCT00387738|Biological|Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate|Escalating doses, 6 weekly subcutaneous (under the skin) injections
16334960|NCT00387738|Biological|Histamine base|Escalating doses, 6 weekly subcutaneous (under the skin) injections
16334961|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
16334962|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
16334963|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
16334964|NCT00387725|Biological|rLP2086|Vaccine administered at 0, 1, and 6 months
16334965|NCT00387712|Other|Velocity based treadmill training|6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill speed is gradually progressed to meet the training heart rate goals for moderate aerobic exercise, when hemiparetic gait velocity can no longer be progressed, incline is added to achieve heart rate training goals. Progression is also based on participant's tolerance, abilities and safety.
16334966|NCT00387712|Other|Duration based treadmill training|6 month of progressive treadmill walking with a safety harness and hand rail support to prevent falls. Treadmill duration is gradually progressed to meet the endurance goals for low aerobic intensity exercise, gait velocity and incline do not progress. Progression is based on participant's tolerance, abilities and safety.
16334967|NCT00387699|Biological|bevacizumab|
16334968|NCT00387699|Drug|cisplatin|
16334969|NCT00387699|Drug|etoposide|
16334970|NCT00387699|Radiation|radiation therapy|
16334971|NCT00387686|Drug|rhBMP-2/CPM|
16334972|NCT00387686|Drug|rhBMP-2/CPM|
16334973|NCT00387686|Drug|rhBMP-2/CPM|
16334974|NCT00387686|Drug|rhBMP-2/CPM|
16334975|NCT00387673|Behavioral|Somatosensory Stimulation and Massed Practice Training|a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects.
16334976|NCT00387660|Drug|carboplatin|Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
16334977|NCT00387660|Drug|irinotecan|Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
16334978|NCT00387647|Drug|Azacitidine|Azacitidine given subcutaneously as outlined in treatment arm.
16334979|NCT00387634|Biological|TBE vaccine for adults|Serology blood draw.
16334980|NCT00387621|Drug|Nesiritide|The first 10 subjects in each group will receive a dose of 5 ug/kg and the next ten subjects will receive 10 ug/kg.
16334981|NCT00387621|Drug|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose.
16334982|NCT00387621|Drug|Saline|Normal saline 0.9% 0.25 ml/kg/min for 60 minutes
16334983|NCT00387608|Drug|veliparib|
16334984|NCT00387608|Other|pharmacological study|
16334985|NCT00387608|Procedure|biopsy|
16334986|NCT00387582|Drug|Ranibizumab (Lucentis)|Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
16334987|NCT00387582|Procedure|Argon Laser|Argon laser at entry to trial and then per protocol for the duration of the study.
16334988|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
16334989|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
16334990|NCT00387569|Biological|MnB vaccine rLP8026|MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
16334991|NCT00387556|Drug|Ondansetron|ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
16334992|NCT00387530|Drug|oral sodium phenylbutyrate|
16334993|NCT00387530|Drug|valganciclovir|
16334994|NCT00387530|Genetic|polymerase chain reaction|
16334995|NCT00387530|Genetic|protein expression analysis|
16334996|NCT00387530|Procedure|biopsy|
16334997|NCT00387517|Drug|Aliskiren/HCTZ|
16334998|NCT00387504|Drug|fenretinide|4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.
16334999|NCT00387504|Other|pharmacological study|samples drawn per protocol
16335000|NCT00387491|Drug|MOA-728|
16335110|NCT00386555|Drug|AG-013736 + docetaxel|
16335111|NCT00386555|Drug|CP-868,596 + AG-013736 + docetaxel|
16335378|NCT00384384|Drug|oral 18B Glycyrrhetinic acid versus placebo|
16335001|NCT00387478|Biological|Tree MATA MPL or Tree MATA|"4 injections of increasing dose strength for Tree MATA MPL or Tree MATA:
~600 SU/0.5 ml
~1600 SU/0.5 ml
~4000 SU/0.5 ml
~4000 SU/0.6 ml
~4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo"
16335002|NCT00387465|Drug|Azacitidine 30mg/m2|Azacitidine 30mg/m2 subcutaneously (SQ)
16335003|NCT00387465|Drug|Entinostat|7mg by mouth (PO) on days 3 and 10 of each cycle
16335004|NCT00387465|Drug|Azacitidine 40mg/m2|Azacitidine 40mg/m2 SQ
16335005|NCT00387452|Behavioral|Aerobic Exercise and Strength Exercise|6 months of aerobic training exercise. regulated by heart rate; work up to 80% of maximal heart rate on treadmill or stationary bike; 3 hours a week, 90% attendance.
16335006|NCT00387452|Behavioral|Strength training|6 months of strength training exercise using weight machines involving legs and arms: 12-15 repetitions of weights per exercise; 3 hours a week, 90% attendance.
16335007|NCT00387439|Behavioral|standard medical treatment + anoperineal physiotherapy.|
16335008|NCT00387439|Behavioral|Standard medical treatment|
16335009|NCT00387426|Drug|sunitinib malate|Given PO
16335010|NCT00387413|Drug|Duloxetine|Subjects will be receive hard gelatin capsules of Duloxetine at 30mg once daily for one week and 60mg once daily for the second week in Treatment Arm B.
16335011|NCT00387413|Drug|GSK189254|Subjects will receive film coated tablet of GSK189254 at 50 mcg once daily for a one week and 100 mcg once daily for the second week in Treatment Arm A.
16335012|NCT00387413|Drug|GSK189254 Placebo|Subjects will receive Placebo matching GSK189254 for 3 weeks in each period.
16335013|NCT00387413|Drug|Duloxetine Placebo|Subjects will receive Placebo matching Duloxetine for 3 weeks in each period.
16335014|NCT00387400|Drug|everolimus|150 mg/m2/day PO Daily x 5, q 4 weeks
16335015|NCT00387400|Drug|temozolomide|2.5 mg PO Daily, beginning day 2 of cycle 1, q 4 weeks
16335016|NCT00387400|Genetic|microarray analysis|Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.
16335017|NCT00387400|Other|immunohistochemistry staining method|Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.
16335018|NCT00387387|Drug|Pazopanib|Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
16335019|NCT00387387|Drug|FOLFOX 6|FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter^2[mg/m^2]), and folinic acid (400 mg/m^2), IV 5-fluorouracil bolus (400 mg/m^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m^2) infusion over 48 hours on Day 1 of every 14-day cycle.
16335020|NCT00387387|Drug|CapeOx|CapeOx treatment consists of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m^2 twice daily.
16335021|NCT00387374|Biological|bevacizumab|Given IV
16335022|NCT00387374|Drug|paclitaxel|Given IV
16335023|NCT00387374|Drug|carboplatin|Given IV
16335024|NCT00387374|Radiation|radiation therapy|Undergo radiotherapy
16335025|NCT00387361|Procedure|Osteopathic Manipulative Treatment|20 minute post-operative osteopathic manipulation as described in the protocol
16335026|NCT00387348|Drug|escitalopram oxalate|escitalopram oxalate 10 mg once daily for 4 weeks
16335027|NCT00387348|Drug|Placebo|one placebo pill identical in appearance to the escitalpram pill once daily
16335028|NCT00387335|Drug|sunitinib malate|Given orally
16335029|NCT00387322|Drug|erlotinib hydrochloride|Given orally
16335030|NCT00387322|Drug|pemetrexed disodium|Given IV
16335031|NCT00387309|Drug|Methylnaltrexone (MOA-728)|
16335032|NCT00387296|Device|functional microarray|functional microarray application
16335033|NCT00387283|Drug|AVI-4020 Injection|
16335034|NCT00387270|Drug|Dimebon|Dimebon 10 or 20 mg TID x 7 days
16335035|NCT00387257|Drug|Rilapladib (SB-659032)|
16335036|NCT00387244|Device|Precision for Spinal Cord Stimulation|Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
16335037|NCT00387231|Procedure|Percutaneous coronary angioplasty/intervention (PCI)|
16335038|NCT00387231|Drug|Anti-ischemic drug therapy|
16335039|NCT00387218|Behavioral|Exercise, Physical therapy|
16335040|NCT00387205|Drug|Pazopanib|Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
16335041|NCT00387192|Drug|Optivate|Plasma-derived Factor VIII
16335042|NCT00387179|Drug|Melatonin|5mg, pill, once
16335043|NCT00387179|Drug|Methylxanthine|2.9 mg/kg, pill, once
16335044|NCT00387179|Procedure|Light Therapy|Bright light exposure
16335045|NCT00387153|Drug|MPC-2130|MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
16335046|NCT00387140|Drug|MK2295|
16335047|NCT00387127|Drug|Lapatinib oral tablets|Lapatinib is administered orally once daily.
16335048|NCT00387127|Drug|radiotherapy|Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease .
16335049|NCT00387127|Drug|cisplatin chemotherapy|Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).
16335050|NCT00387114|Drug|Vitamin C|
16335051|NCT00387101|Device|Dermal - Living Skin Replacement (Dermal - LSR)|
16335052|NCT00387088|Device|Respimat|
16335053|NCT00387088|Drug|Tiotropium|
16335449|NCT00383851|Drug|Temozolomide|
16335054|NCT00387075|Procedure|[123I]β-CIT and SPECT imaging|This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, [123I]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD.
16335055|NCT00387075|Drug|[123I]β-CIT|SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections),
16335056|NCT00387062|Device|Computer-based Cognitive Training|
16335057|NCT00387049|Behavioral|Anxiety Sensitivity Program for Smoking Cessation|
16335058|NCT00387036|Drug|Fluticasone|fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
16335059|NCT00387036|Drug|Comparator: Placebo|Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
16335060|NCT00387023|Drug|Rituximab|250 mg/m^2 IV over 4-6 hours for 2 weeks.
16335061|NCT00387023|Drug|Zevalin|5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
16335062|NCT00387010|Drug|Fentanyl Buccal Tablets|"Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
~Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.
~Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily."
16335063|NCT00386997|Drug|liposomal amphotericin B (AmBisome®)|
16335064|NCT00386984|Drug|Somatostatin (octreotide)|
16335065|NCT00386971|Dietary Supplement|L-carnitine|3 grams daily in liquid form by mouth
16335066|NCT00386971|Other|placebo|1 oz sweet tasting liquid daily by mouth
16335067|NCT00386958|Drug|Povidone-Iodine|
16335068|NCT00386945|Behavioral|Brief counseling (Ask, Advise, Arrange)|Providers are trained to provide Ask, Advise and Arrange (brief cessation counseling) to all tobacco using patients. A Fax-to-Quit referral to a tobacco quit line and written materials on local cessation resources and pharmacotherapy are provided.
16335069|NCT00386919|Procedure|CyberKnife|
16335070|NCT00386906|Procedure|Sentinel Lymph Node Mapping and Biopsy|Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.
16335071|NCT00386893|Procedure|simultaneous EEG/fMRI|fMRI/EEG recordings
16335072|NCT00386893|Device|fMRI|
16335073|NCT00386880|Other|Sounds|
16335074|NCT00386867|Drug|800 mcg misoprostol via oral or buccal administration|
16335075|NCT00386854|Behavioral|physical training|
16335076|NCT00386841|Drug|Escitalopram|Escitalopram 10 mg p.o. per day
16335077|NCT00386841|Drug|Placebo|Placebo
16335078|NCT00386828|Drug|Bevacizumab:|
16335079|NCT00386815|Drug|pemetrexed|
16335080|NCT00386815|Drug|cisplatin|
16335081|NCT00386802|Drug|Antifungal drug. VORICONAZOL. (VFEND®)|I.V charge dose 6 mg/kg/12h (2 doses) Maintenance iv treatment 4 mg/kg/12h during 6 days, followed by oral treatment (200 mg/12h)
16335082|NCT00386776|Other|Computer-based medical history|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
16335083|NCT00386763|Drug|Artemether-lumefantrine|
16335084|NCT00386750|Drug|Artemether-lumefantrine|
16335085|NCT00386724|Device|Precision Spinal Cord Stimulation System|Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
16335086|NCT00386724|Device|Artisan Surgical Lead|Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
16335087|NCT00386711|Behavioral|training on identification of suicide risk and depression|
16335088|NCT00386698|Biological|Fluarix|
16335089|NCT00386698|Biological|adjuvanted influenza vaccine|
16335090|NCT00386685|Drug|larotaxel (XRP9881)|intravenous administration
16335091|NCT00386685|Drug|trastuzumab|intravenous administration
16335092|NCT00386672|Dietary Supplement|Reduced energy (lite) OJ fortified with Calcium and Vitamin D|Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.
16335093|NCT00386672|Behavioral|Nutrition Counseling|Individual and group nutritional counseling by a registered dietician.
16335094|NCT00386672|Dietary Supplement|Reduced energy (lite) OJ without Calcium and Vitamin D|Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.
16335095|NCT00386659|Drug|tenofovir + abacavir + lopinavir/ritonavir|
16335096|NCT00386659|Drug|tenofovir + abacavir + efavirenz|
16335097|NCT00386646|Drug|0.5% carboxymethylcellulose (CMC) with purite and CMC alone|
16335098|NCT00386633|Biological|MVA-mBN32|3 immunizations; first study group: 10E7_TCID50
16335099|NCT00386633|Biological|MVA-mBN32|3 immunizations; second study group: 10E8_TCID50
16335100|NCT00386620|Behavioral|Questionnaire|45 minute survey about health, pain and relationships
16335101|NCT00386620|Behavioral|Interview|Feedback on use of handheld computer electronic diaries (ED).
16335102|NCT00386607|Drug|Aliskiren|Aliskiren 300 mg
16335103|NCT00386607|Drug|Valsartan|Valsartan 320 mg
16335104|NCT00386607|Drug|Hydrochlorothiazide (HCTZ)|Hydrochlorothiazide (HCTZ) 12.5-25 mg
16335105|NCT00386594|Drug|852A|
16335106|NCT00386581|Drug|atomoxetine|
16335107|NCT00386581|Drug|placebo|
16335108|NCT00386555|Drug|docetaxel|
16335109|NCT00386555|Drug|CP-868,596 + docetaxel|
16335112|NCT00386542|Biological|Vaxigrip® trivalent inactivated influenza vaccine|See full description elsewhere in this record.
16335113|NCT00386542|Device|Intradermal spacer on Biojector® 2000 jet injector|See elsewhere in this record for full description.
16335114|NCT00386529|Drug|Aspirin enteric coated pellests 100mg|
16335115|NCT00386516|Drug|GM-CT-01|GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression
16335116|NCT00386516|Drug|5-Fluorouracil|5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression
16335117|NCT00386503|Drug|Artesunate + Amodiaquine|
16335118|NCT00386490|Drug|larazotide acetate|capsule for oral administration
16335119|NCT00386477|Procedure|Vaginal cleansing before cesarean delivery|Cleansing vagina with 1% betadine scrub before cesarean.
16335120|NCT00386464|Device|noninvasive positive pressure ventilation|
16335121|NCT00386451|Device|Catheter locking systems|
16335122|NCT00386438|Procedure|Honan balloon application|
16335123|NCT00386425|Drug|Drotrecogin alfa (activated)|intravenous
16335124|NCT00386412|Drug|Valganciclovir|900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
16335125|NCT00386399|Drug|Mitomycin-C|Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.
16335126|NCT00386386|Other|hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion|Above
16335127|NCT00386373|Drug|Imatinib Mesylate|Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).
16335128|NCT00386360|Drug|Placebo comparator|oral weekly for one year
16335129|NCT00386360|Drug|risedronate|35 mg risedronate, once a week for one year
16335130|NCT00386347|Drug|GSK364735 oral solution and oral tablets|
16335131|NCT00386334|Drug|Eszopiclone|2 mg tablet once per day in the evening
16335132|NCT00386334|Drug|Placebo|Tablet one per day in the evening.
16335133|NCT00386321|Drug|Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)|
16335134|NCT00386308|Drug|Tranexamic acid tablets|3900 mg/Day
16335135|NCT00386308|Drug|Placebo tablets|
16335136|NCT00386282|Drug|mifepristone-misoprostol treatment|200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
16335137|NCT00386269|Drug|Codeine Phosphate Analgesia|
16335138|NCT00386256|Device|Health Buddy, Home telehealth technology|Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
16335139|NCT00386256|Other|Telephone counseling|
16335140|NCT00386243|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.
16335141|NCT00386243|Behavioral|Pain self-management program|The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.
16335142|NCT00386243|Drug|Co-Analgesic Therapy|"Amitriptyline, start at 10-25, titrate to 100 mg Nortriptyline, start at 10-25, titrate to 100 mg
~Gabapentin, titrate up to 900-1200 tid venlafaxine, carbemazepine, duloxetine, and/or pregabalin
~Cyclobenzaprine, titrate to 10 mg TID fluoxetine, sertraline, citalopram"
16335143|NCT00386243|Drug|Opioid Analgesics|Tramadol 50 mg BID or TID and titrate to 100 mg QID Acetaminophen/codeine (300mg/30mg). Take 1 or 2 tablets qid prn pain Acetaminophen/hydrocodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Acetaminophen/oxycodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Morphine SR (30mg). Start at 30 mg twice a day (titrate up to 240mg/day if needed) Methadone (5-10mg). Start at 5mg bid; titrate 10mg tid (max 20mg tid)
16335144|NCT00386230|Drug|ZDV Short (mother)-Short (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Sinfant)
16335145|NCT00386230|Drug|ZDV Short (mother)-Long (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 35 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Smother-Linfant)
16335146|NCT00386230|Drug|ZDV Long (mother)-Short (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Three days of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Sinfant)
16335147|NCT00386230|Drug|ZDV Long (mother)-Long (infant): Comparison of zidovudine durations|Maternal ZDV treatment (300 mg, twice daily) starting at 28 weeks Gestational Age (GA) until the onset of labor, ZDV 300 mg at the onset of labor and then 300 mg every 3 hours until delivery. Six weeks of infant ZDV treatment (2 mg/kg, every 6 hours) starting at birth (Lmother-Linfant)
16335148|NCT00386217|Behavioral|Telephone Survey|Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.
16335149|NCT00386204|Device|Q-switched Ruby Laser|
16335150|NCT00386191|Drug|clopidogrel (SR25990C)|oral administration
16335151|NCT00386178|Drug|Vitamin E supplement rich in gamma tocopherol|daily dose of Vitamin E supplement rich in gamma tocopherol
16335152|NCT00386165|Drug|larazotide acetate|larazotide acetate 4 mg capsules
16335153|NCT00386152|Drug|epoetin alfa|80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks
16335154|NCT00386152|Drug|darbepoetin alfa|500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks
16335155|NCT00386139|Drug|Aliskiren/HCTZ|
16335156|NCT00386126|Drug|Iron Sucrose IV 200mg, once a week, for 5 weeks|
16335157|NCT00386126|Drug|Ferrous sulfate 200mg PO TID, for 8 weeks|
16335158|NCT00386113|Biological|Fluarix and adjuvanted influenza vaccine|
16346077|NCT00296933|Drug|Bupropion XL|
16335159|NCT00386100|Drug|Avandamet 6 mg/1500 mg (ttd)|One 2 mg/ 500 mg capsule will be taken in the AM with the morning meal Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal
16335160|NCT00386100|Drug|Avandamet 4 mg/1000 mg (ttd)|One 2 mg/500 mg capsule will be taken in the AM with the morning meal. One 2 mg/500 mg capsule will be taken in the PM with the evening meal.
16335161|NCT00386100|Drug|Avandamet 2 mg/500 mg (ttd)|one placebo capsule will be taken in the AM with the morning meal one 2 mg/ 500 mg capsule will be taken in the PM with the evening meal.
16335162|NCT00386100|Drug|Avandamet 8 mg/ 2000 mg (ttd)|Two 2 mg/ 500 mg capsules will be taken in the AM with the morning meal. Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal.
16335163|NCT00386100|Drug|Metformin 500 mg (ttd)|One placebo capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
16335164|NCT00386100|Drug|Metformin 1000 mg (ttd)|One 500 mg capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
16335165|NCT00386100|Drug|Metformin 1500 mg (ttd)|One 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsules will be taken in the PM with the evening meal.
16335166|NCT00386100|Drug|Metformin 2000 mg (ttd)|Two 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsule will be taken in the PM with the evening meal.
16335167|NCT00386087|Drug|Enzastaurin Hydrochloride|
16335168|NCT00386074|Drug|NaFeEDTA, Electrolytic Iron|
16335169|NCT00386061|Drug|rimonabant (SR141716)|
16335170|NCT00386048|Behavioral|Brief Cognitive-Behavioral Pain Management Training|Participants complete a manualized, single session of training which includes: (A) education about the causes of sickle cell pain, (B) education about how the nervous system processes pain signals, and (C) explanations of how one can use cognitive and behavioral treatment (CBT) strategies to decrease the extent of pain experienced (all based on how the nervous system processes pain). Four specific CBT skills are taught and practiced by the participant (Progressive muscle relaxation, Controlled Deep Breathing, Imagery, and Distraction). The protocol explicitly emphasizes the use of CBT as a complimentary pain management tool to use in addition to the standard of care methods.
16335171|NCT00386035|Drug|Delayed ART|Participants follow a drug conservation (DC) regimen in which ART is stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count is at least 350 cells/mm3, and then are followed by episodic ART based on CD4 cell count.
16335172|NCT00386035|Drug|Continuous ART|Group 2 participants follow a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.
16335173|NCT00386022|Drug|GnRH|GnRH doses of 25, 75, 250 and 750 ng/kg will be given IV every 4 hr at baseline and after transdermal estradiol
16335174|NCT00386022|Drug|NAL-GLU GnRH antagonist|A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg before and after transdermal estradiol
16335175|NCT00386022|Drug|Estrogen patch|transdermal estrogen patches 0.05mg/day, changing the patch every 86 hr in second part of sequential study
16335176|NCT00386009|Drug|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
16335177|NCT00386009|Drug|Placebo|Placebo tablet taken by mouth once a day for 12 weeks.
16335178|NCT00385996|Drug|Tarceva (Erlotinib)|Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
16335179|NCT00385983|Device|Harmonic Scalpel|
16335180|NCT00385970|Drug|Tegafur-uracil (UFT)|From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
16335181|NCT00385970|Drug|Calcium folinate (LV)|From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5
16335182|NCT00385970|Drug|Krestin (PSK)|From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day
16335183|NCT00385957|Drug|AZT+3TC+IDV+RTV|
16335184|NCT00385957|Drug|AZT+3TC+EFV|
16335185|NCT00385944|Drug|Prasugrel|Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.
16335186|NCT00385944|Drug|Clopidogrel|Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.
16335187|NCT00385931|Drug|Valsartan and simvastatin|
16335188|NCT00385918|Device|Lokomat Training|The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.
16335189|NCT00385918|Other|Home stretching then Lokomat training|Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.
16335190|NCT00385905|Device|Excel Drug-eluting stent|
16335191|NCT00385892|Device|Abdominal binder|
16335192|NCT00385879|Behavioral|Case management|
16335193|NCT00385866|Behavioral|cancer screening and health education|The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.
16335194|NCT00385866|Behavioral|facilitation of Services to improve cancer screening|The intervention group will receive cancer education and faciliation of services in the form of patient navigation
16335195|NCT00385853|Drug|PTK787/ZK 222584|Twice daily for each 28-day cycle
16335196|NCT00385853|Drug|Temozolomide|Daily for each 28-day cycle
16335197|NCT00385853|Procedure|Radiation Therapy|For 7 weeks beginning on day 5 of the first treatment cycle
16335198|NCT00385840|Biological|Influenza Vaccine GSK1247446A|Single dose, intramuscular injection
16335199|NCT00385840|Biological|FluarixTM|Single dose, intramuscular injection
16335200|NCT00385827|Drug|Mitoxantrone|Mitoxantrone 12 mg/m^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2)
16335376|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16335201|NCT00385827|Drug|Siltuximab|Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year
16335202|NCT00385827|Drug|Prednisone|Prednisone 5 mg orally twice daily
16335203|NCT00385801|Drug|Risperidone|
16335204|NCT00385801|Drug|Placebo|
16335205|NCT00385788|Drug|Gemcitabine|800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
16335206|NCT00385788|Drug|Fludarabine|33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
16335207|NCT00385788|Drug|Melphalan|70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
16335208|NCT00385788|Drug|Antithymocyte Globulin|"2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation.
~If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant."
16335209|NCT00385788|Procedure|Allogeneic Stem Cell Infusion|Infusion of stem cells on Day 0.
16335210|NCT00385788|Drug|Tacrolimus|0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
16335211|NCT00385788|Drug|Filgrastim (G-CSF)|Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
16335212|NCT00385788|Drug|Methotrexate|5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
16335213|NCT00385775|Drug|AEG35156|weekly IV solution infused over 2 hrs
16335214|NCT00385762|Drug|paroxetine|paroxetine 10-40mg daily x 5 weeks
16335215|NCT00385749|Device|RV apical vs RV septal defibrillation threshold testing|
16335216|NCT00385736|Biological|adalimumab|Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
16335217|NCT00385736|Biological|adalimumab|Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
16335218|NCT00385736|Biological|placebo|Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
16335219|NCT00385723|Dietary Supplement|Omega 3 (Fish Oil) Supplementation|1.25 g or 2.496 g daily for 4 months
16335220|NCT00385723|Dietary Supplement|Placebo|matching placebo capsule daily for 4 months
16335221|NCT00385710|Drug|valproic acid|Depakine
16335222|NCT00385710|Drug|Placebo|Placebo
16335223|NCT00385697|Drug|Teplizumab|IV dosing daily for 14 days times 2 courses
16335224|NCT00385697|Other|Placebo|IV dosing daily for 14 days times 2 courses
16335225|NCT00385684|Drug|hydrocodone/APAP w placebo PRN|Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID). With liquid placebo available PRN.
16335226|NCT00385684|Drug|hydrocodone/APAP|Participants judged as responders during Phase A continue the same dose of study medication (hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID). Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.
16335227|NCT00385684|Drug|placebo with hydrocodone/APAP PRN|Liquid placebo PRN. Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.
16335228|NCT00385671|Drug|duloxetine hydrochloride|Duloxetine (DLX) once daily (QD), orally (PO)
16335229|NCT00385671|Drug|pregabalin|Pregabalin (PGB) orally (PO)
16335230|NCT00385671|Drug|gabapentin|Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)
16335231|NCT00385658|Drug|Fluvastatin extended release, fenofibrate|
16335232|NCT00385658|Drug|Fixed combination simvastatin/ezetimibe|
16335233|NCT00385645|Drug|Combivir+Kaletra|
16335234|NCT00385645|Drug|Combivir+Reyataz|
16335235|NCT00385632|Drug|Antiretroviral Regimens|Various antiretroviral therapy combinations already being administered to participants
16335236|NCT00385606|Drug|gemcitabine|
16335237|NCT00385606|Drug|prolonged continuous infusion gemcitabine|
16335238|NCT00385606|Drug|cisplatin|
16335239|NCT00385606|Drug|rofecoxib|
16335240|NCT00385593|Drug|Symbicort (budesonide/formoterol) Turbuhaler|
16335241|NCT00385593|Drug|Conventional treatment|
16335242|NCT00385580|Drug|dasatinib|Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression
16335243|NCT00385580|Drug|dasatinib|Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression
16335244|NCT00385567|Drug|PEHRG214|
16335245|NCT00385554|Drug|UC-781 carbomer gel, 0.1% and 0.25%|
16335246|NCT00385541|Drug|Morphine PCA|Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
16335247|NCT00385541|Drug|Hydromorphone PCA|hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
16335248|NCT00385528|Behavioral|Multi-faceted psychiatric intervention|
16335249|NCT00385515|Drug|SNX-1012 (meclocycline sulfosalicylate)|tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
16335250|NCT00385515|Drug|placebo|Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days
16335251|NCT00385502|Drug|EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)|nail lacquer applied daily for 48 weeks
16335252|NCT00385489|Drug|LXR-623|
16335253|NCT00385476|Behavioral|PMKT Questionnaire|Patient Medication Knowledge Tool - Questionnaire entailing the medications the patient is currently taking.
16335254|NCT00385463|Drug|Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID|
16335255|NCT00385450|Drug|Nelfinavir/placebo|1250mg/twice each day/four days.
16335256|NCT00385437|Behavioral|Driving Simulator Testing|
16335257|NCT00385437|Drug|Mirtazapine Treatment|
16335258|NCT00385411|Drug|valproate microgranules|20 to 30 mg/kg/day
16335259|NCT00385398|Drug|erlotinib hydrochloride|Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
16335377|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16335260|NCT00385398|Drug|temozolomide|Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.
16335261|NCT00385398|Radiation|stereotactic radiosurgery|Stereotactic radiosurgery will be performed prior to chemotherapy.
16335262|NCT00385385|Drug|Rifalazil|
16335263|NCT00385372|Procedure|elimination diet|
16335264|NCT00385372|Procedure|provocation diet|
16335265|NCT00385359|Procedure|aerosol drug deposition strategies|
16335266|NCT00385359|Drug|Albuterol|
16335267|NCT00385346|Behavioral|Expressive writing|Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.
16335268|NCT00385333|Procedure|Feasibility Study - Imaging System|
16335269|NCT00385320|Biological|HRV vaccine|
16335270|NCT00385307|Drug|amibegron (SR58611A)|
16335271|NCT00385281|Biological|FluMist|
16335272|NCT00385268|Drug|acamprosate|1998 mg/dau fpr 8 weeks
16335273|NCT00385268|Drug|placebo|placebo pills
16335274|NCT00385255|Biological|Fluarix®|GSK Biologicals' inactivated influenza split virus vaccine.
16335275|NCT00385255|Biological|Boostrix®|GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
16335276|NCT00385242|Procedure|Positron emission tomography: FDG viability imaging|FDG PET viability imaging
16335277|NCT00385242|Other|PET imaging|PET viability imaging
16335278|NCT00385229|Drug|induction of labor|Misoprostol, Dinoprostone, amniotomy, Oxytocin
16335279|NCT00385216|Drug|Nicotine|Nicotine nasal spray 3mg x 1 before surgery
16335280|NCT00385216|Other|Placebo|Placebo nasal spray 0mg x 1 before surgery
16335281|NCT00385203|Drug|AZD2171|45 mg oral tablet once daily dose
16335282|NCT00385190|Drug|HCV-796|
16335283|NCT00385177|Drug|SN2310 Injectable Emulsion|Escalating doses given IV every three weeks
16335284|NCT00385164|Procedure|PET/CT scan for RT planning|
16335285|NCT00385138|Drug|Cangrelor|cangrelor bolus (30 mcg/kg) & cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
16335286|NCT00385138|Drug|clopidogrel|clopidogrel capsules (600 mg) at end of PCI
16335287|NCT00385138|Drug|Placebo bolus & placebo infusion|placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
16335288|NCT00385138|Drug|Placebo capsules - end of PCI|Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
16335289|NCT00385138|Drug|Placebo capsules - end of infusion|Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
16335290|NCT00385125|Drug|Bendamustine|
16335291|NCT00385125|Drug|Rituximab|
16335292|NCT00385112|Procedure|Echocardiogram|2D echocardiogram with Doppler flow
16335293|NCT00385099|Drug|GW876008|
16335294|NCT00385086|Drug|TNF blocker|Treatment with TNF-alpha blocker
16335295|NCT00385086|Drug|Placebo|Treatment with placebo
16335296|NCT00385047|Biological|Group A FMP2.1/AS01B|
16335297|NCT00385047|Biological|Group B FMP2.1/AS02A|
16335298|NCT00385034|Device|Interactive computer based health-risk survey before doctor's visit|
16335299|NCT00385021|Drug|5-Fluorouracil, leucovorin, oxaliplatin, avastin|
16335300|NCT00385008|Drug|Combination Product (sumatriptan succinate / naproxen sodium)|sumatriptan/naproxen sodium
16335301|NCT00385008|Drug|RELPAX(eletriptan) 40mg Tablet|eletriptan tablets
16335302|NCT00384995|Drug|0.9% (154 mEq/L) IV Sodium Chloride|Saline solution
16335303|NCT00384995|Drug|1/6 M (166 mEq/L) IV Sodium Bicarbonate|Bicarbonate solution
16335304|NCT00384982|Procedure|Bone marrow-derived stem cells implantation|percutaneous BM-derived cell therapy
16335305|NCT00384969|Drug|RAD001 and Sorafenib|RAD001 2.5mg to 10.0mg PO QD Sorafenib 400mg PO BID
16335306|NCT00384956|Drug|Azacitidine|
16335307|NCT00384943|Behavioral|Moderate-intensity Exercise|
16335308|NCT00384930|Drug|tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
16335309|NCT00384930|Drug|tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks.
16335310|NCT00384930|Drug|tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks.
16335311|NCT00384930|Drug|tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks.
16335312|NCT00384930|Drug|placebo|Placebo tablet taken by mouth one a day for twelve weeks
16335313|NCT00384917|Drug|Ketoconazole|
16335314|NCT00384904|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
16335315|NCT00384904|Drug|Atazanavir/Ritonavir + Famotidine|Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
16335316|NCT00384904|Drug|Atazanavir/Ritonavir + Famotidine|Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
16335317|NCT00384904|Drug|Atazanavir/Ritonavir|Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
16335318|NCT00384904|Drug|Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine|Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
16335319|NCT00384904|Drug|Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine|Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.
16335320|NCT00384891|Device|Synergo + MMC|Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
16335321|NCT00384891|Drug|Bacillus Calmette-Guérin|Intravesical instillation with BCG (Bacillus Calmette-Guérin)
16335322|NCT00384878|Drug|Cetuximab, Cisplatin,5-Fluorouracil,Leucovorin|
16335323|NCT00384865|Drug|Simvastatin|Simvastatin 40 mg, taken orally, once a day for 6 months
16335324|NCT00384865|Drug|Aspirin|Aspirin 81 mg, taken orally, once a day for 6 months
16335325|NCT00384865|Drug|Placebo|Placebo, taken orally, once a day for 6 months
16335326|NCT00384852|Drug|rhBMP-2/CPM|
16335327|NCT00384839|Drug|azacitidine for injectable suspension|Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
16335328|NCT00384826|Drug|erlotinib|Erlotinib 150 mg/day (until progression)
16335329|NCT00384826|Drug|paclitaxel + carboplatine|Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)
16335330|NCT00384813|Behavioral|Project ASPIRE Home-Based Family Intervention|Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
16335331|NCT00384813|Behavioral|Project ASPIRE Enhanced Treatment As Usual|Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
16335332|NCT00384800|Drug|Thalidomide(THADO), Tegafur/Uracil(UFUR)|
16335333|NCT00384787|Biological|VRC-HIVDNA009-00-VP|HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
16335334|NCT00384787|Biological|VRC-HIVADV014-00-VP|Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
16335335|NCT00384774|Drug|Lasmiditan|Administered as intravenous infusion
16335336|NCT00384774|Drug|Placebo|Administered as intravenous infusion
16335337|NCT00384748|Behavioral|TR intervention|The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during weeks 2, 4, 6, 8 and 12. One additional tele-visit may be scheduled as needed. The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. Visit 3 focuses on functional mobility using adaptive strategy component.
16335338|NCT00384748|Behavioral|In-home messaging device.|The purpose of this aspect of the intervention is to screen for unforeseen problems and to reinforce adherence to the recommended treatment. It will be used to interface with patients daily, but briefly. The in-home messaging device, which resembles a caller ID box is attached to the home telephone line and electrical outlet. Installation of the equipment involves connecting it to the phone line and plugging it into an electrical outlet. The teletherapist receives the clinical data from the in-home messaging device via the internet on a daily basis. It is used to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence.
16335339|NCT00384748|Behavioral|Usual care|Routine VA care.
16335340|NCT00384722|Device|EASYTRAK 3 Downsize Lead|EASYTRAK 3 Downsize Lead
16335341|NCT00384696|Drug|Nicotine Replacement Therapy|4 Weeks of nicotine patch. Patch therapy for participants who smoke >10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches.
16335342|NCT00384696|Behavioral|Questionnaire|Survey taking 1 and 1/2 hours at each study visit.
16335343|NCT00384670|Biological|Dengue Vaccine Formulation 17|Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.
16335344|NCT00384670|Biological|Licensed Japanese Encephalitis (JE) Vaccine|Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.
16335345|NCT00384657|Drug|iron sucrose|"Patients in Group I will receive iv iron sucrose, as described in the study protocol.
~Patient in Group II will receive conventional treatment for chronic heart failure."
16335346|NCT00384644|Device|NiRS measurment of tissue oxygenation|NiRS measurment of tissue oxygenation
16335347|NCT00384631|Other|subconjunctival normal saline|0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
16335348|NCT00384631|Drug|Avastin|intravitreal injection of avastin 2.5mg repeated twice at monthly intervals
16335349|NCT00384618|Drug|pravastatin|
16335350|NCT00384618|Drug|vitamin E|
16335351|NCT00384605|Drug|taranabant|taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
16335352|NCT00384605|Drug|placebo|Placebo capsule once daily. Treatment for 52 weeks.
16335353|NCT00384592|Drug|Esomeprazole|
16335354|NCT00384592|Procedure|Physical exam|
16335355|NCT00384592|Procedure|Pregnancy test if applicable|
16335356|NCT00384579|Drug|Botulinum toxin B|Botulinum Toxin B
16335357|NCT00384579|Drug|Placebo|Placebo
16335358|NCT00384566|Drug|Carvedilol|anit hypertensive medication
16335359|NCT00384566|Drug|Metoprolol|Anti hypertensive medication
16335360|NCT00384553|Drug|Rituximab|
16335361|NCT00384553|Drug|DHAP|
16335362|NCT00384553|Drug|TEC|
16335363|NCT00384553|Drug|autologous stem cell transplantation|
16335364|NCT00384540|Procedure|Dobutamine stress echocardiography, coronarography, brachial arterial echography|DSE: cumulative doses of dobutamine (max = 40 µg/kg/min) and atropine (max = 1.5 mg), to reach a maximal heart rate under clinical, electrocardiographic and echocardiographic surveillancesCoronarography: invasive injection into coronary arteries of a radiological product showing a contrast visible on an x-ray. FMD: Flow-mediated dilatation of the brachial artery induced by 5-min forearm arterial occlusion
16335365|NCT00384527|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
16335366|NCT00384527|Drug|Vancomycin|One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
16335367|NCT00384514|Device|VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors|
16335368|NCT00384501|Device|Intacs|
16335369|NCT00384488|Behavioral|Interactive Voice Response System (IVR)|
16335370|NCT00384475|Drug|Ciclesonide Nasal Spray|
16335371|NCT00384449|Drug|Ranibizumab|Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
16335372|NCT00384436|Drug|escitalopram|
16335373|NCT00384423|Drug|PRX-03140|
16335374|NCT00384410|Drug|Nabilone|
16335375|NCT00384397|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
16335379|NCT00384371|Drug|Botulinum Toxin A|Botulinum Toxin A
16335380|NCT00384371|Drug|Placebo|Placebo
16335381|NCT00384358|Drug|rhBMP-2/CPM|one time injection of 3-5 mL test article at time of internal fracture fixation
16335382|NCT00384358|Drug|rhBMP-2/CPM|one time injection of 3-5 mL test article at time of internal fracture fixation
16335383|NCT00384358|Other|surgical intervention alone|surgical internal fixation of fracture defines the standard of care group
16335384|NCT00384345|Device|Bright Light Therapy|
16335385|NCT00384345|Behavioral|Exercise|
16335386|NCT00384332|Drug|orally-disintegrating olanzapine|5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.
16335387|NCT00384332|Drug|regular olanzapine|5-20 mg. olanzapine daily for approximately 8 weeks.
16335388|NCT00384319|Device|ThermoSuit(R) System|The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.
16335389|NCT00384306|Drug|prednisolone|
16335390|NCT00384293|Drug|Comparator: niacin (+) laropiprant (MK0524A)|niacin (+) laropiprant (2 g) po qd.
16335391|NCT00384293|Drug|Comparator: placebo|niacin (+) laropiprant (2 g) placebo po qd.
16335392|NCT00384280|Drug|Rifampin|
16335393|NCT00384254|Behavioral|5 A|Dental providers are trained to provide Ask, Advise, Assess, Assist and Arrange to all tobacco using patients. Written materials are provided, including information on local cessation resources, pharmacotherapy and tobacco quitlines.
16335394|NCT00384254|Behavioral|3 A|Providers are trained to provide Ask, Advise and Arrange intervention to all tobacco using patients. Written materials, prescription for NRT and a Fax-to-Quit referral are provided.
16335395|NCT00384241|Behavioral|Induced Stress|Participation in an active coping task by playing a video game against another participant.
16335396|NCT00384241|Procedure|Buccal Swab|One Buccal swab collected from each parent
16335397|NCT00384228|Drug|Nilotinib|
16335398|NCT00384215|Drug|insulin glargine [rDNA origin] injection|
16335399|NCT00384202|Drug|Tacrolimus|Immunosuppression
16335400|NCT00384189|Drug|Ciclesonide|inhaled Ciclesonide
16335401|NCT00384189|Drug|Placebo|Ciclesonide placebo-matching inhaler
16335402|NCT00384189|Drug|Salbutamol|Salbutamol inhalation powder
16335403|NCT00384176|Drug|Cediranib|oral tablet once daily
16335404|NCT00384176|Drug|Bevacizumab|intravenous infusion
16335405|NCT00384176|Drug|5-fluorouracil ( in FOLFOX)|intravenous infusion
16335406|NCT00384176|Drug|Leucovorin (in FOLFOX)|intravenous infusion
16335407|NCT00384176|Drug|Oxaliplatin (in FOLFOX)|intravenous infusion
16335408|NCT00384150|Drug|galiximab in combination with rituximab|galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.
16335409|NCT00384137|Drug|Tacrolimus|Immunosuppression
16335410|NCT00384124|Drug|Imiquimod|Imiquimod application M-F for six weeks (total of 30 applications) followed by surgical excision of site
16335411|NCT00384111|Drug|R-CVP + Zevalin Therapeutic Regimen|Standard R-CVP followed by Zevalin Theraeputic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
16335412|NCT00384111|Drug|R-CVP|Standard R-CVP
16335413|NCT00384098|Drug|CTA018 cream|
16335414|NCT00384085|Drug|Insulin Glulisine|Subcutaneous injection up to 1 injection per day
16335415|NCT00384085|Drug|Insulin Glargine|Subcutaneous injection once-a-day
16335416|NCT00384085|Drug|Premixed Insulin|Subcutaneous injection twice-a-day.
16335417|NCT00384085|Drug|Insulin Glulisine|Subcutaneous injection up to 3 injections per day.
16335418|NCT00384072|Drug|bazedoxifene BZA-20|
16335419|NCT00384059|Biological|13-valent Pneumococcal Conjugate Vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
16335420|NCT00384059|Biological|7vPnC|Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
16335421|NCT00384059|Biological|Pediacel|concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
16335422|NCT00384059|Biological|NeisVac-C|concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
16335423|NCT00384059|Biological|Menitorix|concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
16335424|NCT00384046|Drug|Testosterone|patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
16335425|NCT00384046|Drug|Placebo|patch, placebo, patch changed every 3-4 days, 24 weeks
16335426|NCT00384033|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|50 mg tablet, once daily dosing for 8 weeks
16335427|NCT00384033|Drug|Desvenlafaxine Succinate Sustained-Release (DVS SR)|100 mg tablet, once daily dosing for 8 weeks
16335428|NCT00384033|Drug|Placebo|Matching placebo tablets and capsules, once daily dosing for 8 weeks
16335429|NCT00384033|Drug|Duloxetine 60 mg/day|60 mg capsule, once daily dosing for 8 weeks
16335430|NCT00384020|Drug|Paroxetine (Seroxat)|
16335431|NCT00384020|Drug|Escitalopram (Lexapro)|
16335432|NCT00384007|Procedure|Hydrodiscectomy with Spinejet|
16335433|NCT00383994|Drug|GM-CSF|250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
16335434|NCT00383994|Drug|Rituximab|375 mg/m^2 by vein followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
16335435|NCT00383994|Biological|NK Cell Infusion|NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
16335436|NCT00383942|Drug|Misoprostol|Misoprostol,25 micrograms every 4 hours.
16335437|NCT00383942|Device|Catheter|A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
16335438|NCT00383929|Drug|Candesartan cilexetil|32mg oral
16335439|NCT00383929|Drug|Hydrochlorothiazide|12.5 mg oral
16335440|NCT00383929|Drug|Hydrochlorothiazide|25 mg oral
16335441|NCT00383916|Drug|pantoprazole|
16335442|NCT00383903|Biological|HRV vaccine|Two or three oral doses
16335443|NCT00383890|Drug|Dexmedetomidine HCL Injection|
16335444|NCT00383890|Drug|Placebo|
16335445|NCT00383877|Drug|insulin detemir|
16335446|NCT00383877|Drug|insulin NPH|
16335447|NCT00383864|Drug|Pegylated interferon and ribavirin|
16335448|NCT00383851|Drug|ATN-224|
16335450|NCT00383838|Behavioral|brief, voluntary substance use intervention|
16335451|NCT00383825|Procedure|Anterior segment indocyanine green angiography|
16335452|NCT00383812|Drug|Intravitreal Bevacizumab|
16335453|NCT00383799|Drug|iv Amiodarone|
16335454|NCT00383799|Drug|iv Procainamide|
16335455|NCT00383786|Drug|NK1 Antagoist (GR205171)|
16335456|NCT00383786|Procedure|Psychophysiology (Trauma Script)|
16335457|NCT00383786|Procedure|Psychophysiology (Verbal Threat)|
16335458|NCT00383786|Procedure|Psychophysiology (Fear Conditioning)|
16335459|NCT00383786|Procedure|Psychophysiology (Affective Modulation)|
16335460|NCT00383786|Procedure|Psychophysiology (Heart rate variability)|
16335461|NCT00383786|Procedure|Lumbar Puncture|
16335462|NCT00383786|Procedure|24-hour plasma sampling|
16335463|NCT00383786|Procedure|MRI|
16335464|NCT00383773|Procedure|Retinal endo vascular surgery|
16335465|NCT00383760|Drug|eribulin mesylate|Given IV
16335466|NCT00383747|Drug|transdermal nicotine patch|14mg transdermal nicotine application
16335467|NCT00383747|Drug|Transdermal Nicotine Patch|14mg transdermal nicotine application
16335468|NCT00383734|Device|Newfill|1 to 7 injections of drug
16335469|NCT00383734|Device|Eutrophill|1 to 7 injections of drug
16335470|NCT00383721|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
16335471|NCT00383721|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
16335472|NCT00383721|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 52 weeks
16335473|NCT00383721|Drug|Formoterol MDI|Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
16335474|NCT00383721|Drug|Placebo|Placebo MDI twice a day for 26 weeks
16335475|NCT00383708|Drug|lanreotide (Autogel formulation)|120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
16335476|NCT00383708|Drug|Pegvisomant|Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
16335477|NCT00383695|Biological|cetuximab|
16335478|NCT00383695|Drug|capecitabine|
16335479|NCT00383695|Drug|oxaliplatin|
16335480|NCT00383695|Procedure|adjuvant therapy|
16335481|NCT00383695|Procedure|conventional surgery|
16335482|NCT00383695|Procedure|neoadjuvant therapy|
16335483|NCT00383695|Radiation|radiation therapy|
16335484|NCT00383682|Drug|morphine and mexiletine|
16335485|NCT00383669|Dietary Supplement|Multivitamins (including B, C and E)|One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
16335486|NCT00383669|Dietary Supplement|Multivitamins B, C and E|One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
16335487|NCT00383656|Drug|GnRH|75 ng/kg GnRH IV
16335488|NCT00383656|Device|Pump|portable, infusion pump for GnRH
16335489|NCT00383643|Drug|zolpidem tartrate|
16335490|NCT00383643|Drug|sodium oxybate|
16335491|NCT00383643|Drug|Matching Placebos|
16335492|NCT00383630|Biological|Intramyocardial injection of bone marrow mononuclear cells|6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
16335493|NCT00383630|Biological|Intramyocardial injection of CD34+ selected bone marrow mononuclear cells|6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
16335494|NCT00383630|Device|LVAD alone|LVAD implantation without any intramyocardial injection of bone marrow cells.
16335495|NCT00383591|Biological|Hepatitis B adjuvanted vaccine|
16335496|NCT00383591|Biological|Engerix-B|
16335497|NCT00383578|Drug|Vildagliptin 100 mg qd|
16335498|NCT00383578|Drug|Metformin 1500 mg daily|
16335499|NCT00383565|Drug|romidepsin|Given IV
16335500|NCT00383552|Drug|Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID|MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
16335501|NCT00383552|Drug|Mometasone Furoate MDI (MF MDI)|MF 100 mcg via metered dose inhaler twice daily for 26 weeks
16335502|NCT00383552|Drug|Formoterol Fumarate 10 mcg|F via metered dose inhaler 10 mcg twice a day for 26 weeks
16335503|NCT00383552|Drug|Placebo|Placebo metered dose inhaler twice a day for 26 weeks
16335504|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 1
16335505|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 2
16335506|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Vaccine Lot 3
16335507|NCT00383539|Biological|Inactivated Split-virion influenza vaccine|Control Vaccine
16335508|NCT00383526|Biological|Inactivated, split-virion influenza vaccine|Vaccine
16335509|NCT00383526|Biological|Inactivated, split-virion influenza vaccine|Vaccine
16335510|NCT00383513|Biological|Epratuzumab|360 mg/m^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour
16335511|NCT00383500|Device|Flexitouch|A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
16335512|NCT00383500|Device|Class 1 compression garment|Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).
16335513|NCT00383487|Drug|Calcitriol|0.5 micrograms/kilogram q weekly
16335514|NCT00383487|Drug|Naproxen-n-butyl nitrate|400 mg BID, oral
16335515|NCT00383474|Drug|Bortezomib|Given IV
16335516|NCT00383474|Other|Laboratory Biomarker Analysis|Correlative studies
16335517|NCT00383474|Drug|Tipifarnib|Given orally
16335518|NCT00383461|Behavioral|smoking cessation intervention|
16335519|NCT00383461|Other|counseling intervention|
16335520|NCT00383448|Drug|Clofarabine|days -7 through -3: 40 mg/m^2 intravenously over 2 hours
16347048|NCT00289601|Drug|eptifibatide|
16335521|NCT00383448|Procedure|Total body Irradiation|Administration of TBI: The dose of TBI will be 200 cGy given in a single fraction on day -1. The dose rate will be between 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.
16335522|NCT00383448|Drug|Melphalan|day -2: 140 mg/m^2 intravenously over 30 minutes
16335523|NCT00383448|Biological|Hematopoietic Stem Cell Transplantation|receives infusion of stem cells on day 0
16335524|NCT00383448|Drug|Alemtuzumab|0.3 mg/kg intravenously (IV) days -12 through -8
16335525|NCT00383448|Drug|mycophenylate mofetil|Day -3 through Day 30: 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously. Consider dose modification if renal impairment (GFR<25 mL/minute corrected)
16335526|NCT00383448|Device|Cyclosporine A|"Patients will receive CsA therapy beginning on day -3. Dosing of CsA will be 2.5 mg/kg/dose intravenously (IV); if the recipient body weight is <40 kg, dosing will be 3 times daily, and if > 40 kg twice daily. An attempt will be made to maintain a trough cyclosporine level of 250 mg/L to 350 mg/L. Once the patient can tolerate oral medications and has a normal gastrointestinal transit time, CsA will be converted to an oral form at a dose 2.5 x the current IV dose (maximum 12.5 mg/kg/day as initial oral dose).
~CsA taper begins at day +100."
16335527|NCT00383448|Drug|Hydroxyurea|hydroxyurea (HU) beginning day -28 and continuing through alemtuzumab administration
16335528|NCT00383435|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
16335529|NCT00383435|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
16335530|NCT00383435|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 52 weeks
16335531|NCT00383435|Drug|Formoterol MDI|Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
16335532|NCT00383435|Drug|Placebo|Placebo MDI twice a day for 26 weeks
16335533|NCT00383422|Drug|Arzoxifene|20 mg, oral, tablet, once a day for 52 weeks
16335534|NCT00383422|Drug|Raloxifene|60 mg, oral, tablet, once a day for 52 weeks
16335535|NCT00383409|Drug|multivitamins|
16335536|NCT00383409|Drug|placebo|
16335537|NCT00383396|Drug|Topical Cyclosporine|
16335538|NCT00383383|Biological|Hepatitis B adjuvanted vaccine|
16335539|NCT00383383|Biological|Engerix-B|
16335540|NCT00383370|Drug|VEGF Trap|VEGF Trap formulation 1, ITV-1
16335541|NCT00383370|Biological|VEGF Trap|VEGF Trap formulation 2 at higher concentration in Open label cohort
16335542|NCT00383357|Drug|zolpidem|
16335543|NCT00383344|Procedure|FDG PET/CT|
16335544|NCT00383331|Drug|Pemetrexed|"A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles
~B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles"
16335545|NCT00383331|Drug|Gemcitabine|"A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles
~B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles"
16335546|NCT00383318|Procedure|Gene mutation sample|
16335547|NCT00383305|Device|Cool-Cap|
16335548|NCT00383292|Drug|tasisulam|Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.
16335549|NCT00383279|Other|counseling intervention|
16335550|NCT00383279|Other|study of socioeconomic and demographic variables|
16335551|NCT00383266|Drug|Pemetrexed|
16335552|NCT00383266|Drug|Carboplatin|
16335553|NCT00383253|Behavioral|caloric restriction - 10%|Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
16335554|NCT00383253|Behavioral|caloric restriction - 25%|Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
16335555|NCT00383253|Behavioral|caloric restriction - 50%|Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
16335556|NCT00383253|Behavioral|caloric restriction - Control|Subjects maintained on their baseline caloric intake (caloric restriction = none)
16335557|NCT00383240|Drug|mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
16335558|NCT00383240|Drug|Mometasone furoate MDI (MF MDI) 200 mcg|MF 200 mcg via metered dose inhaler twice daily for 26 weeks
16335559|NCT00383240|Drug|formoterol fumarate 10 mcg|F via metered dose inhaler 10 mcg twice a day for 26 weeks
16335560|NCT00383240|Drug|Placebo|Placebo metered dose inhaler twice a day for 26 weeks
16335561|NCT00383227|Biological|Hepatitis B adjuvanted vaccine|
16335562|NCT00383214|Drug|Epratuzumab|360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
16335563|NCT00383214|Other|Placebo|Intravenous
16335564|NCT00383201|Device|OptiFree Multi-Purpose Disinfecting Solution|
16335565|NCT00383188|Drug|placebo|Capsule, once daily (QD) for 12 weeks
16335566|NCT00383188|Drug|PH-797804|Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
16335567|NCT00383188|Drug|PH-797804|Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
16335568|NCT00383188|Drug|PH-797804|Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
16335569|NCT00383188|Drug|PH-797804|Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
16335570|NCT00383175|Other|Autorefractor, standard clinical instrument|Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.
16335571|NCT00383162|Drug|Combination Product (sumatriptan succinate / naproxen sodium)|Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer.
16335572|NCT00383162|Drug|Placebo|Matching placebo tablet.
16335573|NCT00383149|Drug|Ixabepilone|Intravenous Infusion (IV), 32 mg/m^2 every 21 days.
16335574|NCT00383149|Drug|Cetuximab|Initial dose of 400 mg/m^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m^2 IV over 1 hour.
16335575|NCT00383136|Drug|tirofiban high-bolus dose regimen|bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.
16335576|NCT00383136|Drug|Abciximab|bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute
16335577|NCT00383123|Biological|Fluarix™|"Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
~*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1."
16335578|NCT00383123|Biological|Fluzone|"Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
~*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1."
16335579|NCT00383097|Genetic|LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES|1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
16335580|NCT00383097|Genetic|LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES|1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
16335581|NCT00383084|Behavioral|Lifestyle physical activity (LPA)|Bi-weekly, 60-minute group sessions spread over 12 weeks. Participants will receive education on how to increase their daily physical activity, goal setting, problem solving strategies to overcome barriers to being more physically active, and finding new ways to integrate short bouts of LPA into their daily lives.
16335582|NCT00383084|Behavioral|Fibromyalgia education|Participants will meet monthly for 1.5 to 2 hours for a total of 3 months. The sessions will be divided into three components: (1) education, (2) question and answer, and (3) social support.
16335583|NCT00383071|Biological|H5N1 vaccine|Monovalent subvirion H5N1 vaccine (rgA/Vietnam/1203/2004) 90 mcg/mL Manufactured by Sanofi Pasteur Inc, Swiftwater, PA.
16335584|NCT00383071|Procedure|Apheresis|Once subjects achieved a high antibody titer (>1:160), they could begin apheresis to collect plasma.
16335585|NCT00383058|Drug|the extract of green tea|
16335586|NCT00383045|Drug|Buprenorphine/Subutex|
16335587|NCT00383045|Drug|Naltrexone|
16335588|NCT00383045|Procedure|Drug counseling|
16335589|NCT00383032|Drug|mifepristone|
16335590|NCT00383019|Drug|Xalatan|latanoprost 0.005%, one rop once daily in evening
16335591|NCT00383019|Drug|Xalacom|latanoprost 0.005% adn timolol 0.5%, one drop, once daily
16335592|NCT00383006|Behavioral|Skills for affect regulation (behavior)|
16335593|NCT00382993|Drug|Placebo|Matching placebo tablet
16335594|NCT00382993|Drug|Combination Product (sumatriptan succinate/naproxen sodium)|Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
16335595|NCT00382980|Biological|Aluminum hydroxide|Adjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg.
16335596|NCT00382980|Biological|Inactivated Vero cell based whole virus influenza A/H5N1|Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant.
16335597|NCT00382980|Drug|Placebo|Saline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart.
16335598|NCT00382967|Procedure|DaTSCAN SPECT imaging|A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.
16335599|NCT00382954|Drug|Velcade|velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
16335600|NCT00382954|Drug|Idarubicin|I.V., 8, or 10 or 12 mg/m^2 weekly (days 1, 8, 15, and 22) for 4 weeks
16335601|NCT00382941|Device|Red and near infrared LED phototherapy device|
16335602|NCT00382928|Device|Defibrillation of pulseless VT/VF by AECD|In case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation.
16335603|NCT00382915|Device|CReSSmicro handheld topography device|The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
16335604|NCT00382902|Device|OptiFree Multi-Purpose Disinfecting Solution|
16335605|NCT00382889|Drug|beclomethasone/salbutamol combination|
16335606|NCT00382889|Drug|beclomethasone|
16335607|NCT00382889|Drug|salbutamol|
16335608|NCT00382863|Device|HeartNet Ventricular Support System|The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.
16335609|NCT00382863|Drug|Optimal Medical/Device Therapy|Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.
16335610|NCT00382850|Procedure|Nissen fundoplication|
16335611|NCT00382837|Drug|Epratuzumab|
16335612|NCT00382824|Dietary Supplement|Coenzyme Q10|active drug
16335613|NCT00382824|Other|Placebo|Placebo
16335614|NCT00382811|Drug|phenoxodiol|400mg phenoxodiol three times daily in 28 day cycles.
16335615|NCT00382811|Drug|carboplatin|AUC=2 weekly in 28 day cycles
16335616|NCT00382811|Drug|placebo|every 8 hours daily in 28 day cycles
16335617|NCT00382798|Drug|RO5024048|
16335618|NCT00382785|Behavioral|moderated support|one 12-week online support group led by a professional healthcare provider
16335619|NCT00382785|Behavioral|peer-led|12-week online support in a peer-led format
16335620|NCT00382772|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
16335621|NCT00382759|Procedure|stem cell transplant|
16335622|NCT00382746|Device|EarlySense monitoring device|
16335623|NCT00382733|Drug|Oral Topotecan|Topotecan will be received in one of the five dose levels:0.25mg/day,0.5mg/day, 0.75mg/day, 1.0mg/day, and 1.25mg/day.
16335624|NCT00382720|Drug|Docetaxel + Oxaliplatin|"Dose level 1 (non-optimal dose):
~Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1
~Dose level 2 (optimal dose):
~Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1"
16335625|NCT00382720|Drug|Docetaxel + Oxaliplatin + 5-FU|"Dose level 1 (non-optimal dose):
~Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.
~Dose level 2 (optimal dose):
~Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1."
16335626|NCT00382720|Drug|Docetaxel + Oxaliplatin + Capecitabine|"Dose level 1 (optimal dose):
~Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.
~Dose level 2 (non-optimal dose):
~Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously."
16335627|NCT00382707|Device|cortical magnetic stimulation provided by an eight-shaped coïl placed upon the skull.|
16335628|NCT00382694|Drug|Fludarabine|
16335629|NCT00382681|Device|FID 107027 Multi-Purpose Disinfecting Solution|Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.
16335630|NCT00382681|Device|ReNu MultiPlus Multi-Purpose Solution No Rub Formula|Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.
16335631|NCT00382668|Drug|Dasatinib|Tablets, Oral, 50 mg, once daily, for one day
16335632|NCT00382668|Drug|Dasatinib|Tablets, Oral, 20 mg, once daily for one day
16335633|NCT00382668|Drug|Dasatinib|Tablets, Oral, 70 mg, once daily for one day
16335634|NCT00382655|Procedure|Education and referral|
16335635|NCT00382642|Drug|Ondansetron + Cognitive Behavioral Therapy|13 week outpatient trial
16335636|NCT00382642|Drug|Placebo + Cognitive Behavioral Therapy|13 week outpatient trial
16335637|NCT00382629|Drug|BHT-3009 0.5 mg|
16335638|NCT00382629|Drug|BHT-3009 1.5 mg|
16335639|NCT00382629|Drug|Placebo|
16335640|NCT00382616|Drug|Phosphatidylserine-Omega3|
16335641|NCT00382603|Device|OptiFree Multi-Purpose Disinfecting Solution|
16335642|NCT00382590|Drug|5-Azacytidine|75 mg/m^2 daily for 7 days (days 1-7) via subcutaneous injection.
16335643|NCT00382590|Drug|Ara-C|20 mg twice daily via subcutaneous injection for 10 days.
16335644|NCT00382590|Drug|Valproic Acid (VPA)|50 mg/m^2 orally daily days 1-7.
16335645|NCT00382577|Drug|Itopride|
16335646|NCT00382577|Drug|Placebo|
16335647|NCT00382551|Behavioral|Moderate daily consumption of Red wine|
16335648|NCT00382551|Behavioral|Moderate daily consumption of beer|
16335649|NCT00382551|Behavioral|Moderate consumption of fruit juice rich in polyphenolics|
16335650|NCT00382538|Drug|Addition of mifepristone 200 mg 24 hours before induction|
16335651|NCT00382525|Device|Cardiac Rhythm Management device|
16335652|NCT00382512|Drug|Raptiva (efalizumab)|
16335653|NCT00382499|Drug|Lidocaine Intravenous Infusion|1.5 mg/kg IV bolus on induction, 3 mg/kg/hr infusion from inducation until fascia closure
16335654|NCT00382486|Procedure|Reduce the risk of allograft rejection|
16335655|NCT00382473|Behavioral|Aerobic exercise program - 8 weeks|No drugs. Regular aerobic exercise in structured prescription format
16335656|NCT00382460|Drug|PRAVASTATIN SODIUM|
16335657|NCT00382447|Device|standard nebulizer|Standard small volume nebulizer for aerosolized medication delivery
16335658|NCT00382447|Device|breath actuated nebulizer|Nebulizer that dispenses medication only during the inspiratory phase
16335659|NCT00382434|Procedure|presence of an emergency pharmacist in the ED|
16335660|NCT00382421|Drug|bisoprolol|
16335661|NCT00382421|Drug|amlodipine|
16335662|NCT00382421|Drug|molsidomine|
16335663|NCT00382421|Drug|acetylsalicylic acid|
16335664|NCT00382408|Biological|DR-5001|All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.
16335665|NCT00382408|Other|Placebo|All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.
16335666|NCT00382395|Device|SOLX Gold Shunt GMS-plus|Single use implant
16335667|NCT00382395|Device|Ahmed FP7 Glaucoma Valve|Single use implant
16335668|NCT00382382|Other|diffusion tensor imaging (DTI)|Both groups will have a diffusion tensor imaging (DTI) perform.
16335669|NCT00382356|Drug|Dutasteride|once daily dosing of 0.5mg Dutasteride for 12 months
16335670|NCT00382343|Drug|Sulfamethoxazole/trimethoprim|Sulfamethoxazole/trimethoprim prophylaxis
16335671|NCT00382330|Drug|Ciclopirox|
16335672|NCT00382317|Drug|Iobitridol|
16335673|NCT00382304|Drug|tolevamer potassium-sodium (GT267-004)|
16335674|NCT00382291|Drug|Regular Titration|Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks.
16335675|NCT00382291|Drug|Placebo|The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks.
16335676|NCT00382291|Drug|Slow Titration|Sertraline will be administered in slow titration. Treatment with sertraline will last 18 weeks.
16335805|NCT00381615|Biological|PC7|IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
16335911|NCT00380679|Biological|Influenza vaccination|
16347049|NCT00289588|Drug|Mupirocin (drug)|
16335677|NCT00382278|Procedure|Autologous bone marrow-derived mononuclear cells infusion|Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism.
16335678|NCT00382265|Drug|tamsulosin|tamsulosin 0.4mg po qd for 28 days
16335679|NCT00382265|Other|Placebo|placebo po qd for 28 days
16335680|NCT00382252|Procedure|computed tomography|
16335681|NCT00382252|Procedure|positron emission tomography|
16335682|NCT00382252|Procedure|radiofrequency ablation|
16335683|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
16335684|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
16335685|NCT00382239|Drug|exenatide (LY2148568)|subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
16335686|NCT00382239|Drug|Placebo|subcutaneous injection twice daily, 0.02 mL to 0.04 mL
16335687|NCT00382226|Drug|Azopt|
16335688|NCT00382213|Drug|Olmesartan medoxomil|
16335689|NCT00382213|Drug|Placebo|
16335690|NCT00382200|Drug|decitabine|
16335691|NCT00382200|Drug|tretinoin|
16335692|NCT00382200|Genetic|DNA methylation analysis|
16335693|NCT00382200|Genetic|cytogenetic analysis|
16335694|NCT00382200|Genetic|microarray analysis|
16335695|NCT00382200|Other|flow cytometry|
16335696|NCT00382200|Other|immunohistochemistry staining method|
16335697|NCT00382187|Biological|MF59 adjuvanted H5N1 influenza vaccine|"MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
~non-adjuvanted influenza vaccine containing 15 ug of H5N1"
16335698|NCT00382174|Drug|Placebo|Topical administration of 0.00% thymosin beta 4 qd up to 84 days
16335699|NCT00382174|Drug|Thymosin Beta 4|Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
16335700|NCT00382161|Drug|Fluvastatin-sodium|
16335701|NCT00382148|Drug|omalizumab|SC repeating dose
16335702|NCT00382135|Drug|tadalafil|20mg tadalafil tablet taken by mouth once a day for 40 weeks
16335703|NCT00382135|Drug|placebo|Placebo tablet taken by mouth once a day for 40 weeks
16335704|NCT00382109|Drug|thiotepa|Given IV
16335705|NCT00382109|Drug|cyclophosphamide|Given IV
16335706|NCT00382109|Drug|tacrolimus|Given IV or orally
16335707|NCT00382109|Drug|methotrexate|Given IV
16335708|NCT00382109|Drug|sirolimus|Given orally
16335709|NCT00382109|Radiation|total body irradiation|Part of the transplant preparatory regimen
16335710|NCT00382096|Drug|Vildagliptin|
16335711|NCT00382096|Drug|Metformin|
16335712|NCT00382096|Drug|Vildagliptin + Metformin|
16335713|NCT00382083|Drug|1000 mg acetaminophen|
16335714|NCT00382083|Drug|800 mg ibuprofen|
16335715|NCT00382083|Drug|1 oz 4% lidocaine gel|
16335716|NCT00382070|Drug|Letrozole|Letrozole 2.5 mg taken orally once daily for 5 years
16335717|NCT00382070|Other|Placebo|Placebo tablet taken orally once daily for 5 years
16335718|NCT00382057|Drug|Testosterone|
16335719|NCT00382057|Drug|Anastrozole|
16335720|NCT00382057|Drug|Goserelin|
16335721|NCT00382044|Drug|Eprex; Neorecormon; Aranesp|
16335722|NCT00382031|Drug|Zalutumumab|Individual dose titration weekly i.v doses
16335723|NCT00382031|Other|Control|Best Supportive Care
16335724|NCT00382018|Drug|chemotherapy|No administration details available
16335725|NCT00381979|Other|Supportive Expressive Therapy|
16335726|NCT00381966|Device|robotic placement device|this device is a robotic arm that utilizes a template as a guidance system to precisely inplant radioactive brachytherapy seeds directly to the prostate.
16335727|NCT00381953|Drug|Peginterferon alfa-2a|
16335728|NCT00381953|Drug|Interferon alfa-2a|
16335729|NCT00381953|Drug|Ribavirin|
16335730|NCT00381940|Drug|ifosfamide|Given IV
16335731|NCT00381940|Drug|bortezomib|Given IV
16335732|NCT00381940|Drug|vinorelbine tartrate|Given IV
16335733|NCT00381940|Biological|filgrastim|Given IV or SC
16335734|NCT00381927|Behavioral|Physician Counseling|
16335735|NCT00381914|Drug|Vitamin D|400 IU vitamin D / day
16335736|NCT00381914|Drug|Vitamin D|800 IU vitamin D / day
16335737|NCT00381914|Drug|Vitamin D|1200 IU vitamin D / day
16335738|NCT00381901|Biological|trastuzumab|
16335739|NCT00381901|Genetic|polymorphism analysis|
16335740|NCT00381901|Procedure|adjuvant therapy|
16335741|NCT00381888|Drug|fondaparinux sodium|Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
16335742|NCT00381875|Biological|E1M184V peptide vaccine|
16335743|NCT00381875|Biological|incomplete Freund's adjuvant|
16335744|NCT00381875|Biological|sargramostim|
16335745|NCT00381875|Other|immunoenzyme technique|
16335746|NCT00381862|Drug|aprepitant|Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle
16335747|NCT00381862|Drug|dexamethasone|Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4
16335748|NCT00381862|Drug|fluorouracil|as per institutional standard of care
16335749|NCT00381862|Drug|irinotecan hydrochloride|as per institutional standard of care
16335750|NCT00381862|Drug|leucovorin calcium|as per institutional standard of care
16335751|NCT00381862|Drug|oxaliplatin|as per institutional standard of care
16335752|NCT00381862|Drug|palonosetron hydrochloride|Palonosetron 0.25 mg IV push on day 1 only.
16335753|NCT00381862|Procedure|quality-of-life assessment|baseline
16335806|NCT00381615|Biological|MenC-CRM|MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.
16347050|NCT00289575|Device|MBCP|
16335754|NCT00381849|Drug|Cystone|"Participants will take 2 pills, 2 times a day.
~Each tablet of Cystone contains:
~Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg."
16335755|NCT00381849|Drug|Sugar Pill (Placebo)|Participants will take 2 pills, 2 times a day for 6 weeks.
16335756|NCT00381836|Drug|Darbepoetin Alfa|
16335757|NCT00381823|Behavioral|Cognitive Behavioral Therapy|
16335758|NCT00381810|Drug|Rituximab|Rituximab will be supplied as a liquid for intravenous infusion.
16335759|NCT00381810|Drug|Methylprednisolone|
16335760|NCT00381810|Drug|Acetaminophen|
16335761|NCT00381810|Drug|Diphenhydramine|
16335762|NCT00381797|Biological|Bevacizumab|Given IV
16335763|NCT00381797|Radiation|Fludeoxyglucose F-18|Undergo fludeoxyglucose F18 PET
16335764|NCT00381797|Drug|Irinotecan Hydrochloride|Given IV
16335765|NCT00381784|Behavioral|Printed materials|"Role model stories comprise the heart of printed materials distributed throughout the target community. The role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. Depending on the population they are meant to reach and what behavior they are trying to influence, the stories may include examples of people who now carry condoms with them, talked to a partner about condom use, use condoms consistently, avoid sharing needles, or exhibited other risk reduction behaviors."
16335766|NCT00381784|Behavioral|Peer advocates|"Core Element 1 Core group of young gay men and additional volunteers recruited from the community. The core group and volunteers comprise the peer advocates who design and carry out all program activities.
~Core Element 2 Designated space where most social events and meetings are held; also serves as a drop in center where young men can meet and socialize during specified hours.
~Core Element 3 Social events to attract young gay men and to promote safer sex. Core Element 4 Teams of young gay men go to locations frequented by young gay men to discuss and promote safer sex, deliver appealing informational literature on HIV risk reduction and distribute condoms.
~Core Element 5 Meetings of eight to 10 young gay men to discuss factors contributing to unsafe sex among men. Men practice safer sex negotiation and correct condom use skills.
~Core Element 6 Publicity campaigns that attract men to the program by word of mouth and through articles and advertisements in gay newspapers."
16335767|NCT00381771|Behavioral|Conservative management for xerostomia|Active hydration (drinking more than 10 cups of water per day), Humidification, Oral gargle with a diluted (0.05% to 0.1%) chlorhexidine solution, Sugarless chewing gum, Saliva-stimulating sour juice (sugarless orange juice), Commercial artificial saliva, Nasal saline spray 3 to 4 times a day, Warm massage of the 4 major salivary glands.
16335768|NCT00381758|Drug|Methylphenidate Extended Release Capsules|
16335769|NCT00381732|Drug|tadalafil|2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
16335770|NCT00381732|Drug|placebo|Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.
16335771|NCT00381719|Drug|AGN 203818|3 mg Capsule twice daily for 4 weeks
16335772|NCT00381719|Drug|AGN 203818|20 mg Capsule twice daily for 4 weeks
16335773|NCT00381719|Drug|AGN 203818|60 mg Capsule twice daily for 4 weeks
16335774|NCT00381719|Drug|placebo capsule|Capsule twice daily for 4 weeks
16335775|NCT00381706|Biological|cetuximab|given IV
16335776|NCT00381706|Drug|ECF|epirubicin and 5-fluorouracil given IV
16335777|NCT00381706|Drug|IC|cisplatin and irinotecan given IV
16335778|NCT00381706|Drug|FOLFOX|oxaliplatin , leucovorin and 5-fluorouracil IV
16335779|NCT00381693|Drug|azacitidine|
16335780|NCT00381680|Drug|vincristine sulfate|Given IV
16335781|NCT00381680|Drug|prednisone|Given PO
16335782|NCT00381680|Drug|doxorubicin hydrochloride|Given IV
16335783|NCT00381680|Drug|pegaspargase|Given IM
16335784|NCT00381680|Drug|cytarabine|Given IT or IV
16335785|NCT00381680|Drug|methotrexate|Given IT or IV
16335786|NCT00381680|Drug|dexamethasone|Given PO
16335787|NCT00381680|Drug|etoposide|Given IV
16335788|NCT00381680|Drug|cyclophosphamide|Given IV
16335789|NCT00381680|Drug|leucovorin calcium|Given IV or PO
16335790|NCT00381680|Biological|filgrastim|Given IV or SC
16335791|NCT00381680|Drug|asparaginase|Given IM
16335792|NCT00381680|Drug|mercaptopurine|Given PO
16335793|NCT00381667|Drug|GW642444M|M salt
16335794|NCT00381667|Drug|GW642444H|H salt
16335795|NCT00381667|Other|placebo|placebo
16335796|NCT00381654|Drug|AV-412|Solid oral dosage; 4 dosage strengths; 25, 50, 100, or 200 mg per capsule Dosing Frequency: Once daily dosing for 4 weeks (4 weeks equals 1 cycle)
16335801|NCT00381628|Procedure|epithelial cells and blood lymphocyte extraction|Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.
16335802|NCT00381615|Biological|rMenB|One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
16335803|NCT00381615|Biological|rMenB+OMV|One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
16335804|NCT00381615|Biological|DTaP-Hib-IPV|Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
16335863|NCT00381108|Drug|Placebo Tablet|Two tablets, twice daily.
16335864|NCT00381108|Drug|Pomegranate Tablet|Two tablets, twice daily.
16335807|NCT00381615|Biological|MenC-Hib|MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.
16335808|NCT00381615|Biological|MMR|IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.
16335809|NCT00381602|Drug|GHRP-1/AG 70 mg depot in ESRD|
16335810|NCT00381602|Other|Placebo|
16335811|NCT00381589|Drug|ipratropium bromide 0.03% spray|
16335812|NCT00381576|Behavioral|Resistance training|Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living
16335813|NCT00381563|Device|Patellofemoral realigning knee brace|Knee brace that changes the tracking of the patella over the femur bone
16335814|NCT00381563|Device|Non-aligning knee brace|Knee brace that does not change the tracking of the patella over the femur bone
16335815|NCT00381550|Drug|fludarabine phosphate|Given IV
16335816|NCT00381550|Drug|triapine|Given IV
16335817|NCT00381550|Procedure|laboratory biomarker analysis|Correlative study
16335818|NCT00381537|Drug|phenobarbitone|
16335819|NCT00381537|Drug|carbamazepine|
16335820|NCT00381524|Behavioral|Increase condom use|Voluntary increase in condom use
16335821|NCT00381511|Drug|low molecular weight heparin|
16335822|NCT00381485|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
16335823|NCT00381485|Drug|Mometasone furoate/formoterol (MF/F) combination|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
16335824|NCT00381485|Drug|Mometasone furoate MDI (MF MDI)|MF 400 mcg via metered dose inhaler twice daily for 12 weeks
16335825|NCT00381472|Drug|Ropinirole|
16335826|NCT00381446|Device|Marketed contact lens care products|
16335827|NCT00381433|Drug|AVI-4065 Injection|
16335828|NCT00381420|Device|drug-eluting stent|sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
16335829|NCT00381420|Device|bare-metal stent|un-coated Bx VELOCITY Stent
16335830|NCT00381407|Behavioral|Organizational Skills Training|Participants in the OST group attend twenty 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session.
16335831|NCT00381407|Behavioral|Contingency management (CM)|"Participants in the CM group will attend twenty 1-hour sessions over 10 weeks. CM trains parents and teachers to identify desired end behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal."
16335832|NCT00381394|Drug|sitamaquine|
16335833|NCT00381381|Drug|Donepezil|2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
16335834|NCT00381368|Drug|Ibandronic acid|
16335835|NCT00381355|Procedure|Written Action Plan for Acute Asthma|
16335836|NCT00381342|Drug|exenatide|Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
16335837|NCT00381342|Drug|exenatide|Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
16335838|NCT00381342|Drug|placebo|subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
16335839|NCT00381329|Behavioral|Motivational Interviewing (MI)|MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.
16335840|NCT00381329|Behavioral|Structured Brief Advice (SBA)|SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.
16335841|NCT00381316|Drug|Technetium Tc99m Tetrofosmin injections|Single Isotope: be 555 to 888 MBq (15 to 24 mCi) MYOVIEW at Rest/i.v./bolus.
16335842|NCT00381316|Drug|Thallous Chloride T1-201|Myoview SPECT Imaging
16335843|NCT00381303|Drug|darunavir|600mg bid for 48 wks
16335844|NCT00381303|Drug|ritonavir|100mg bid for 48 wks
16335845|NCT00381290|Behavioral|Diet|The prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day.
16335846|NCT00381290|Behavioral|Exercise|The program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home.
16335847|NCT00381277|Drug|Gatorade|
16335848|NCT00381277|Drug|Performance|
16335849|NCT00381264|Drug|Cesamet™ (nabilone)|
16335850|NCT00381251|Drug|Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg|
16335851|NCT00381238|Drug|rosiglitazone|Extended Release Tablets
16335852|NCT00381225|Procedure|Ultra-sound guided radio-frequency ablation|
16335853|NCT00381212|Biological|AGS-004|Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
16335854|NCT00381199|Drug|Amitriptyline Hydrochloride|
16335855|NCT00381199|Drug|Nabilone|
16335856|NCT00381186|Behavioral|diet- and exercise intervention|
16335857|NCT00381173|Drug|Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)|Patients who meet all entry criteria will be administered 600 mg/m^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).
16335858|NCT00381160|Behavioral|Reduction of sugar-sweetened beverage consumption|Multi-component intervention aimed at reducing sugar-sweetened beverage consumption. Components include delivery of non-caloric beverages to home in combination with behavioral modification (telephone counseling with parent; check in visit with participant).
16335859|NCT00381147|Drug|Clarithromycin|
16335860|NCT00381134|Drug|losartan 100 mg orally once daily|
16335861|NCT00381134|Drug|spironolactone 25 mg orally once daily|
16335862|NCT00381134|Drug|placebo once orally once daily|
16335865|NCT00381095|Drug|Pregabalin|Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
16335866|NCT00381095|Drug|Placebo|Placebo
16335867|NCT00381082|Drug|1) MOOV Head Lice Treatment (Ego Pharmaceutical).|
16335868|NCT00381082|Drug|Banlice Mousse Aerosol (Pfizer, Australia)|
16335869|NCT00381082|Drug|3) KP24 Medicated Foam (Nelson Laboratories)|
16335870|NCT00381069|Behavioral|Family & Community Recreation Center Intervention|The two year intervention involves changing the environment and policies in community recreation centers to promote physical activity and healthy eating choices. The Recreation Specialist will meet with recreation center staff monthly to create action plans that work towards this goal. Family Health Coaches will be in contact with intervention families twice a month either through a phone consultation, workshop at the recreation center,or home visit. Intervention families will receive a monthly mailing highlighting tips for healthy eating and physical activity. MOVE families will be encouraged to utilize the recreation center as a resource in supporting their child's physical activity and healthy eating behaviors.
16335871|NCT00381056|Behavioral|Labor and Delivery Team Coordination Course|
16335872|NCT00381043|Drug|Acamprosate (Campral)|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
16335873|NCT00381030|Drug|carvedilol plus nurse management|
16335874|NCT00381017|Drug|Peg interferon alpha-2b|
16335875|NCT00381004|Drug|Cyclophosphamide|Course 1: 250 mg/m^2 by vein over 5-30 minutes on Days 2, 3, and 4; Course 2 - 6: 250 mg/m^2 by vein over 5-30 minutes on Days 1 - 3
16335876|NCT00381004|Drug|Fludarabine|Course 1: 25 mg/m^2 by vein over 5-30 minutes on Days 2,3, and 4; Course 2 - 6: 25 mg/m^2 by vein over 5-30 minutes on Days 1 - 3
16335877|NCT00381004|Drug|Sargramostim|Course 1: 250 mcg/m^2 subcutaneous (SQ) on Days -1 and Days 5 - 11; Course 2 - 6: 250 mcg/m^2 SQ on Days -1 and Days 4 - 10
16335878|NCT00381004|Drug|Rituximab|Course 1: 375 mg/m^2 by vein over 2-6 Hours on Day 1; Course 2 - 6: 500 mg/m^2 by vein over 2-6 Hours on Day 1
16335879|NCT00380991|Drug|lactoserum|
16335880|NCT00380978|Procedure|combined spinal epidural analgesia|Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.
16335881|NCT00380978|Procedure|late analgesia (systemic)|Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.
16335882|NCT00380965|Drug|Cesamet™ (nabilone)|
16335883|NCT00380952|Device|Dune Device|
16335884|NCT00380939|Drug|Atorvastatin|
16335885|NCT00380939|Drug|Pravastatin|
16335886|NCT00380926|Drug|polyunsatturated fatty acids (fish oil)|
16335887|NCT00380913|Drug|Cesamet™ (nabilone)|
16335888|NCT00380900|Drug|AGG-523|
16335889|NCT00380887|Drug|Premarin|
16335890|NCT00380874|Drug|Pregabalin|150- 600 mg/day (double blind in divided doses)
16335891|NCT00380874|Drug|Placebo|Placebo
16335892|NCT00380861|Device|Total knee replacement using the PFC Sigma RPF knee implant.|Total knee replacement
16335893|NCT00380861|Device|Total knee replacement using the PFC Sigma RP knee implant|Total knee replacement
16335894|NCT00380848|Procedure|Hemodiafiltration|
16335895|NCT00380835|Drug|Amrubicin|
16335896|NCT00380822|Drug|miglitol|
16335897|NCT00380809|Procedure|Rotational Atherectomy + PES|
16335898|NCT00380809|Procedure|Standard Treatment (PES without Rotational Atherectomy)|
16335899|NCT00380796|Drug|Collection of safety data for Cohort 1|Twice-yearly collection of information about cancer incidence and cause of death among patients who participated in clinical trials of infliximab in the treatment of COPD. The follow-up period is 5 years.
16335900|NCT00380783|Drug|AGN 203818|
16335901|NCT00380770|Drug|Generic HAART Triomune : d4T, 3TC, NVP|Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)
16335902|NCT00380770|Drug|Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV|Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks) Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.
16335903|NCT00380757|Procedure|bystander CPR using 30:2 ratio vs 15:2 ratio|Participants will use 2 CPR techniques with different chest compression to ventilation ratios
16335904|NCT00380744|Drug|LY2189102|
16335905|NCT00380744|Drug|placebo|
16335906|NCT00380731|Behavioral|Individual Cognitive Behavioral Therapy|CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
16335907|NCT00380718|Drug|pemetrexed|"500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.
~*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets <50 x 10^9/L; absolute neutrophil count <1.0 x 10^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade >2; Skin Grade >2; Serum bilirubin >3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase >10 x ULN; Other non-hematologic toxicities Grade >2 (except nausea, vomiting)."
16335908|NCT00380705|Drug|MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks|
16335909|NCT00380692|Drug|Atomoxetine|
16335910|NCT00380692|Drug|Placebo|
16335912|NCT00380679|Biological|Pneumococcal polysaccharide vaccination|
16335913|NCT00380666|Procedure|PET/CT scan|
16335914|NCT00380653|Drug|sapacitabine|
16335915|NCT00380640|Drug|Trimethoprim|This group will receive the active intervention (trimethoprim) first, followed by the placebo.
16335916|NCT00380640|Drug|Trimethoprim|This group will start the study with placebo, followed by the active intervention (trimethoprim).
16335917|NCT00380627|Drug|MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|
16335918|NCT00380614|Drug|Lamivudine|
16335919|NCT00380601|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks
16335920|NCT00380588|Drug|gemcitabine|1000 milligrams per square meter (mg/m2), intravenous (IV)
16335921|NCT00380588|Drug|cisplatin|25 milligrams per square meter (mg/m2), intravenous (IV)
16335922|NCT00380575|Drug|YM087|
16335923|NCT00380562|Behavioral|Experience Corps|High intensity volunteering (15 hours a week or more) over a two year time period working with children in grades K-3 in Baltimore City Schools. Controls are assigned to usual activities for two years and then offered opportunity to volunteer with children at the end of two year.
16335924|NCT00380549|Diagnostic Test|Blood ion levels|Blood ion levels or the levels of cobalt and chromium ions in the blood and urine will be analyzed.
16335925|NCT00380536|Behavioral|Peer-Led Health Education Class|Participants will participate in group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
16335926|NCT00380523|Drug|MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|
16335927|NCT00380497|Drug|PEG-Lyte®|
16335928|NCT00380497|Drug|Pico-Salax®|
16335929|NCT00380484|Drug|Budesonide|200µg daily
16335930|NCT00380484|Drug|Montelukast|5 mg daily
16335931|NCT00380471|Device|Bath PUVA|
16335932|NCT00380458|Device|Coblation (radiofrequency-based device)|
16335933|NCT00380445|Drug|Vildagliptin|
16335934|NCT00380419|Behavioral|Interpersonal Psychotherapy (IPT)|IPT sessions will address adjustment to pregnancy, concerns about interpersonal relationships, and parenting concerns. Sessions will be weekly, but may be determined by clinical desires of patient and therapist.
16335935|NCT00380406|Drug|Leuprolide acetate|
16335936|NCT00380393|Biological|GSK malaria vaccine 257049 Vaccine|3 dose intramuscular injection
16335937|NCT00380393|Biological|Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine|3 dose intramuscular injection
16335938|NCT00380380|Drug|Vildagliptin|
16335939|NCT00380367|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.
16335940|NCT00380354|Drug|GSK256066|
16335941|NCT00380341|Procedure|Instrument-applied spinal manipulative therapy|
16335942|NCT00380328|Drug|neratinib|HKI-272
16335943|NCT00380315|Drug|AG1321001(drug)|
16335944|NCT00380302|Drug|AVE1625|
16335945|NCT00380289|Drug|Thiazide and beta blocker|
16335946|NCT00380276|Drug|MPC-7869|800 mg BID Oral dosing
16335947|NCT00380263|Drug|PACAP38|10 pmol/kg/min given one time
16335948|NCT00380250|Drug|Lubiprostone|
16335949|NCT00380250|Drug|Placebo|
16335950|NCT00380237|Biological|H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)|Live attenuated H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
16335951|NCT00380224|Drug|bifeprunox, olanzapine|
16335952|NCT00380211|Biological|Influenza vaccine (A/H3N2, A/H1N1, and B strains)|
16335953|NCT00380211|Biological|Fluarix|
16335954|NCT00380198|Drug|Apadenoson|
16335955|NCT00380172|Device|Rheopheresis blood filtration|
16335956|NCT00380159|Drug|elvucitabine|elvucitabine 10 mg in combination with background ART
16335957|NCT00380159|Drug|Lamivudine|
16335958|NCT00380159|Drug|Emtricitabine|
16335959|NCT00380146|Drug|sulfadoxine-pyrimethamine|
16335960|NCT00380133|Drug|SB681323|5 mg and 2.5 mg tablets - The tablets will be round (9.0 mm in diameter) and white and provided in labelled bottles
16335961|NCT00380133|Drug|Prednisolone|5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous)
16335962|NCT00380133|Drug|Placebo|Tablets matched to SB681323 or prednisolone
16335963|NCT00380120|Drug|sodium warfarin|dosage: as much as it is required to prolong the international normalized ratio, checked every 2-3 weeks, between 2.0 and 3.0
16335964|NCT00380120|Drug|Sodium warfarin|As much drug as it is necessary to prolong the international normalized ratio between 2.0 and 3.0
16335965|NCT00380081|Drug|zolpidem tartrate sublingual tablet 3.5mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16335966|NCT00380081|Drug|zolpidem tartrate sublingual tablet 1.75mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16335967|NCT00380081|Drug|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16335968|NCT00380068|Drug|Ambrisentan|Oral tablets taken once daily.
16335969|NCT00380055|Behavioral|Navigation Services|Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
16335970|NCT00380055|Behavioral|Cancer education|Community health workers provide cancer education appropriate for Medicare participants.
16335971|NCT00380042|Device|Cortical Stimulation|Cortical stimulation of prefrontal cortex
16335972|NCT00380042|Device|Sham|Sham stimulation
16335973|NCT00380029|Drug|Erlotinib|Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
16335974|NCT00380029|Procedure|Radical Cystectomy|Will occur 4 weeks prior to dosing with erlotinib
16335975|NCT00380016|Procedure|Percutaneous Transluminal Angioplasty|
16335976|NCT00380003|Drug|EVT 201|
16335977|NCT00379990|Drug|GW274150|60 mg /day
16335978|NCT00379990|Drug|Prednisolone|7.5 mg/day
16335979|NCT00379990|Other|Placebo|Placebo
16335980|NCT00379977|Biological|diphtheria, tetanus, pertussis & Hib vaccine|
16335981|NCT00379964|Drug|caspofungin acetate|Cancidas 50 mg dose followed by 70 mg load on day 1 was administered in Indian adults with persistent fever and neutropenia for a maximum duration of empirical treatment from 28 days ((for patients without documented infection) to 90 days (for patients with documented baseline or emergent fungal infection). Patients were treated until the resolution of neutropenia (ANC>500/mm3), and for up to 72 hours later.
16335982|NCT00379951|Drug|ertapenem sodium|ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.
16335983|NCT00379938|Biological|VAI-VP705 (parvovirus B-19 vaccine)|Recombinant human parvovirus B-19 capsids at dose levels: 25 micrograms of VAI-VP705 with and without MF59 adjuvant and 2.5 micrograms with MF59 adjuvant.
16335984|NCT00379938|Drug|Placebo|Saline control
16335985|NCT00379938|Biological|MF-59|Adjuvant
16335986|NCT00379925|Behavioral|Physical Activity and Dietary Health Promotion Program|Churches within the intervention group will receive a committee training and church cook training designed to teach them how to do a self-assessment of current practices and develop a plan for their program. The intervention is based on the structural model of health behavior and targets opportunities, mass media (within the church), guidelines and policies, and church environment. Intervention churches also receive monthly intervention mailings to support intervention implementation.
16335987|NCT00379912|Drug|Azacitidine|Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
16335988|NCT00379912|Drug|Erythropoietin|Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
16335989|NCT00379912|Drug|Azacitidine (Monotherapy)|Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
16335990|NCT00379899|Drug|cinacalcet|Low dose vitamin D with cinacalcet
16335991|NCT00379886|Drug|Propofol Thiopental|
16335992|NCT00379873|Device|ProAdjuster|
16335993|NCT00379860|Drug|LXR-623|
16335994|NCT00379847|Drug|conivaptan|IV
16335995|NCT00379834|Drug|Cosopt|Cosopt twice daily in both eyes
16335996|NCT00379821|Drug|Atovaquone-proguanil|Atovaquone-proguanil: once a day for 3 days, Pediatric tablet: 62.5 mg/25 mg, Full strength tablet: 250 mg/100 mg
16335997|NCT00379821|Drug|Artesunate|Artesunate: 4mg/kg once a day for 3 days, 50 mg tablet
16335998|NCT00379821|Drug|Azithromycin|Azithromycin 30 mg/kg once a day for 3 days, 200 mg/5cc suspension
16335999|NCT00379821|Drug|Chloroquine|Chloroquine: 10 mg/kg on days 0 and 1, 5 mg/kg/day on day 2, 100 mg tablet.
16336000|NCT00379808|Drug|montelukast|10 mg tablet (masked by capsule) daily for 1 month
16336001|NCT00379808|Drug|Placebo|1 lactose-containing capsule daily for 1 month
16336002|NCT00379795|Drug|Ranibizumab 0.5 mg|Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)
16336003|NCT00379782|Other|Navigation|Navigation and escourt
16336004|NCT00379769|Drug|Rosiglitazone|Rosiglitazone maximum 8 mg per day
16336005|NCT00379769|Drug|Sulfonylurea|Sulfonylurea (SU) maximum permitted daily dose
16336006|NCT00379769|Drug|Metformin|Metformin maximum permitted daily dose .
16336007|NCT00379756|Drug|LEVITRA (vardenafil)|active comparator
16336008|NCT00379756|Drug|placebo|placebo comparator
16336009|NCT00379743|Behavioral|Health coordinator (or patient navigator)|Individuals randomized to receive the less intensive intervention receive educational materials only. Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer. The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services.
16336010|NCT00379743|Behavioral|Educational materials only|A brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained.
16336011|NCT00379730|Drug|Prednisolone|
16336012|NCT00379717|Drug|Cisplatinum|
16336013|NCT00379717|Drug|Docetaxel|
16336014|NCT00379717|Device|Tomotherapy|
16336015|NCT00379691|Drug|phenylephrine|
16336016|NCT00379665|Drug|Cisplatin|1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
16336017|NCT00379652|Behavioral|Medical Practice Improvement|The details for the medical practice improvement intervention will be decided at a later date.
16336018|NCT00379652|Behavioral|Patient Education and Support|The details for the patient education and support intervention will be decided at a later date.
16336019|NCT00379652|Other|Combination Intervention to Include Medical Practice Improvement and Patient Education and Support|The details for this combination intervention will be decided at a later date.
16336020|NCT00379639|Drug|Romidepsin|7, 10 or 12 mg/m^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.
16336021|NCT00379639|Drug|Gemcitabine|800 or 1000 mg/m^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.
16336022|NCT00379626|Drug|cognitive and hormone treatment|cognitive and hormone (Leuprorelin) treatment
16336023|NCT00379613|Drug|sugammadex|"After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
~At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered"
16336024|NCT00379613|Drug|Placebo|"After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
~At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered"
16336025|NCT00379600|Drug|rosiglitazone XR|
16336026|NCT00379587|Drug|Rituximab|Rituximab at months 3, 6, 9 and 12 post-transplant
16336027|NCT00379587|Drug|375 mg/m2 RRituximab|Rituximab 375 mg/m2 q3months
16336028|NCT00379574|Drug|Bortezomib|"Bortezomib:
~For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
~For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks."
16336029|NCT00379574|Drug|Cyclophosphamide|cyclophosphamide 750mg/m2 day 1, every 2 weeks
16336030|NCT00379574|Drug|Doxorubicin|doxorubicin 50 mg/m2 day 1, every 2 weeks
16336031|NCT00379574|Drug|Vincristine|vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
16336032|NCT00379574|Drug|Prednisolone|prednisolone 100 mg days 1-5, every 2 weeks
16336033|NCT00379574|Drug|Lenograstim|Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
16336034|NCT00379561|Drug|PSA-Activated PSA-PAH1|
16336035|NCT00379548|Behavioral|2 groups of population responding to 2 types of diets|Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.
16336036|NCT00379535|Drug|potassium iodide|per os
16336037|NCT00379535|Drug|placebo|per os
16336038|NCT00379522|Drug|Vasopressin|10 minutes after standard shock treatment 10 IU arginine vasopressin will be injected; if shock persists for 5 minutes, another 10 IU arginine vasopressin will be injected; after 5 minutes persisting shock, the last 10 IU arginine vasopressin will be injected; Total duration: approx. 15 minutes; Dose per intravenous injection: 10 IU; max. dose: 30 IU arginine vasopressin
16336039|NCT00379522|Drug|Saline placebo|Placebo for arginine vasopressin
16336040|NCT00379509|Drug|lapatinib ditosylate|Patients will be assigned in cohorts of 3. Dose levels of GW572106 will include 500mg, 1000mg,1500 mg (additional levels at 750 mg and 1250 mg will be added if needed). Lapatinib is an oral drug. It is taken every day.
16336041|NCT00379509|Genetic|TdT-mediated dUTP nick end labeling assay|Genetic analysis of tumor tissue
16336042|NCT00379509|Genetic|gene expression analysis|Genetic analysis of tumor tissue.
16336043|NCT00379509|Genetic|microarray analysis|Genetic analysis of tumor tissue.
16336044|NCT00379509|Other|immunohistochemistry staining method|Laboratory analysis of tumor tissue.
16336045|NCT00379509|Procedure|biopsy|Serial biopsies by skin punch or core biopsy or fine needle aspiration.
16336046|NCT00379509|Radiation|radiation therapy|Radiotherapy will be delivered at standard dose and fractionation. For patients who have not received previous locoregional radiotherapy, 50-56 Gy will be delivered to the regional lymph nodes and/or chest wall at a dose of 2 Gy per fraction, 5 days per week followed by a boost to the sites of gross involvement to a total dose of 60-70 Gy over a course of 6-7 weeks. For patients who have received adjuvant radiotherapy, a dose of 35-45 Gy will be delivered to sites of chest wall involvement at a dose of 1.8 Gy per fraction over 4-5 weeks. In either de novo or reirradiated settings, the total dose to the brachial plexus will not exceed 60 Gy.
16336047|NCT00379496|Procedure|Antidepressants|
16336048|NCT00379496|Procedure|acupuncture|
16336049|NCT00379483|Drug|Deferasirox|
16336050|NCT00379470|Device|NovoTTF-100A|multiple four-week courses of continuous NovoTTF-100A treatment
16336051|NCT00379457|Biological|dactinomycin|
16336052|NCT00379457|Drug|carboplatin|
16336053|NCT00379457|Drug|cyclophosphamide|
16336054|NCT00379457|Drug|doxorubicin hydrochloride|
16336055|NCT00379457|Drug|etoposide|
16336056|NCT00379457|Drug|ifosfamide|
16336057|NCT00379457|Drug|topotecan hydrochloride|
16336058|NCT00379457|Drug|vincristine sulfate|
16336059|NCT00379457|Drug|vinorelbine tartrate|
16336060|NCT00379457|Procedure|conventional surgery|
16336061|NCT00379457|Radiation|radiation therapy|
16336062|NCT00379444|Behavioral|Standard intervention (counseling + self-help written materials)|counseling
16336063|NCT00379444|Behavioral|Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)|counseling
16336064|NCT00379431|Drug|Administration of rituximab and methylprednisolone|"Rituximab:
~Pharmaceutical form: Concentrate for solution for infusion. Maximum duration of treatment: 28 weeks Maximum dose allowed: 2000 mg (use of total dose) Route of administration: intravenous use."
16336065|NCT00379418|Drug|Abciximab|
16336066|NCT00379405|Drug|Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours|Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
16336067|NCT00379392|Behavioral|Mental Imagery only|Listening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity
16336068|NCT00379392|Procedure|Mental Imagery and Constraint induced therapy|Listening to an audio tape to enhance mental imagery AND participation in constraint induced therapy
16336069|NCT00379379|Device|electroacupuncture|
16336070|NCT00379366|Device|External ionizing radiations|14 Gy in one time
16336071|NCT00379353|Drug|Thalidomide|100 mg capsules orally, once a day for 14 days.
16336072|NCT00379353|Drug|Placebo|Two placebo capsules orally, once a day for 14 days.
16336073|NCT00379340|Drug|doxorubicin hydrochloride|Given IV
16336074|NCT00379340|Drug|liposomal vincristine sulfate|Given IV
16336075|NCT00379340|Procedure|conventional surgery|
16336076|NCT00379340|Radiation|3-dimensional conformal radiation therapy|
16336077|NCT00379340|Biological|dactinomycin|Given IV
16336078|NCT00379340|Drug|cyclophosphamide|Given IV
16336079|NCT00379340|Drug|etoposide|Given IV
16336080|NCT00379327|Procedure|Acupuncture|Acupuncture administered in last three weeks of pregnancy
16336081|NCT00379327|Device|Non-puncturing Acupuncture Needle|Streitsberg non-Acupuncture Needle
16336082|NCT00379314|Procedure|TVT and TVT-O minimally invasive surgical procedures|
16336083|NCT00379314|Procedure|Surgery for female stress urinary incontinence|
16336084|NCT00379301|Procedure|Radiofrequency ablation|Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
16336085|NCT00379288|Drug|mometasone furoate combination MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
16336086|NCT00379288|Drug|mometasone furoate combination MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
16347704|NCT00283920|Drug|[(11)C] PBR28|
16336087|NCT00379288|Drug|Fluticasone/Salmeterol 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
16336088|NCT00379288|Drug|Fluticasone/Salmeterol 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
16336089|NCT00379262|Drug|Capecitabine|Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
16336090|NCT00379262|Drug|Adjuvant chemotherapy using PF (5-Fluorouracil )|Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
16336091|NCT00379262|Drug|Induction chemotherapy using PF (5-Fluorouracil)|Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
16336092|NCT00379249|Drug|Rosuvastatin|
16336093|NCT00379236|Device|EUFLEXXA™|EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate (molecular weight 2.4-3.6 MD); sodium chloride, 17 mg; disodium hydrogen phosphate dodecahydrate, 1.12 mg; sodium dihydrogen phosphate dihydrate, 0.1 mg; enough water for injection to make 2.0 ml. EUFLEXXA™ is supplied in 2.25 ml nominal volume, disposable prefilled glass syringes containing 2 mL of EUFLEXXA™. Only the contents of the syringe are sterile. EUFLEXXA™ is nonpyrogenic. See package insert for further details.
16336094|NCT00379236|Device|placebo|Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Only the contents of the syringe are sterile.
16336095|NCT00379223|Procedure|vitrectomy with radial optic neurotomy|
16336096|NCT00379210|Behavioral|Mindfulness Meditation Training (MMT)|8-week training course in mindfulness meditation
16336097|NCT00379210|Behavioral|Nutrition Education course|8-week course in nutrition
16336098|NCT00379197|Drug|naltrexone|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.
16336099|NCT00379197|Procedure|PET scan|Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.
16336100|NCT00379171|Behavioral|Cow's milk with fish oil|
16336101|NCT00379171|Behavioral|Cow's milk without fish oil|
16336102|NCT00379171|Behavioral|Formula with fish oil|
16336103|NCT00379171|Behavioral|Formula without fish oil|
16336104|NCT00379158|Drug|Micronutrient supplements|
16336105|NCT00379145|Drug|trabectedin|
16336106|NCT00379132|Drug|131-I-TM-601 (chlorotoxin)|"Patients will be administered 1 - 3 (Test Doses A, B, and Dose C) escalating doses of 131I-TM601 by intravenous (IV) administration. Each dose will be administered as a single administration, scheduled at one-week intervals.
~Test Dose A - 10 mCi (+/- 20%)/0.2 mg TM601 (131I-TM601) Test Dose B - 20 mCi (+/- 20%)/0.4 mg TM601 (131I-TM601) Dose C - 30 mCi (+/- 10%)/0.6 mg TM601 (131I-TM601)"
16336107|NCT00379119|Other|diagnostic laboratory biomarker analysis|
16336108|NCT00379119|Other|flow cytometry|
16336109|NCT00379119|Other|physiologic testing|
16336110|NCT00379119|Procedure|computed tomography|
16336111|NCT00379106|Procedure|Arm exercises.|Basic active exercise program at home.
16336112|NCT00379106|Procedure|Arm Exercises|Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises
16336113|NCT00379093|Behavioral|Brief advice|"The intervention will have the following components:
~A) At the time of the recruitment visit, all intervention group patients will receive:
~A personalized risk report;
~An educational booklet titled Healthy Drinking as You Age;
~A drinking diary;
~Brief advice to reduce their drinking by their physicians;
~B) After the recruitment visit, all intervention group patients will receive up to 3 telephone calls from a health educator. After each call, intervention group patients may choose to receive a letter updating their health risks.
~Also, at the conclusion of their interaction with the health educator, they may choose to have a letter summarizing the calls sent to their physician."
16336114|NCT00379080|Procedure|conventional surgery|Undergo surgery
16336115|NCT00379080|Drug|tandutinib|Given orally
16336116|NCT00379080|Other|pharmacological study|Correlative studies
16336117|NCT00379080|Other|Tissue samples|Correlative studies
16336118|NCT00379067|Drug|Tamsulosin OCAS|Adrenoceptor antagonist
16336119|NCT00379067|Drug|Placebo|placebo
16336120|NCT00379054|Behavioral|telephone based skills training intervention|
16336121|NCT00379041|Biological|bleomycin sulfate|
16336122|NCT00379041|Drug|doxorubicin hydrochloride|
16336123|NCT00379041|Drug|mechlorethamine hydrochloride|
16336124|NCT00379041|Drug|prednisone|
16336125|NCT00379041|Drug|procarbazine hydrochloride|
16336126|NCT00379041|Drug|vinblastine sulfate|
16336127|NCT00379041|Drug|vincristine sulfate|
16336128|NCT00379041|Radiation|radiation therapy|
16336129|NCT00379028|Drug|Budesonide/Formoterol Turbuhaler|
16336130|NCT00379028|Drug|Salmeterol/Fluticasone Diskus|
16336131|NCT00379015|Biological|trastuzumab|
16336132|NCT00379015|Drug|cyclophosphamide|
16336133|NCT00379015|Drug|docetaxel|
16336134|NCT00379015|Drug|epirubicin hydrochloride|
16336135|NCT00379015|Procedure|conventional surgery|
16336136|NCT00379015|Procedure|neoadjuvant therapy|
16336137|NCT00378989|Behavioral|Consultation at the occupational health services|Consultation at the occupational health services
16336138|NCT00378976|Drug|valacyclovir|500 mg twice-daily oral
16336139|NCT00378976|Drug|matching placebo|twice daily as per experimental drug
16336140|NCT00378963|Device|ProAdjuster|
16336141|NCT00378950|Behavioral|Teach to Goal (TTG)|The TTG program includes the Brief Educational Intervention (BEI) educational intervention, as well as education about diuretic self adjustment. In addition, follow-up phone calls are given to the TTG group to further reinforce the initial training and provide further training so participants will master the task.
16336142|NCT00378950|Behavioral|Brief Educational Intervention (BEI)|The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.
16336143|NCT00378937|Drug|acetaminophen|
16336144|NCT00378937|Drug|codeine phosphate|
16336145|NCT00378937|Drug|dextropropoxyphene hydrochloride|
16336146|NCT00378937|Drug|morphine sulfate|
16336147|NCT00378937|Drug|oxycodone hydrochloride|
16336148|NCT00378937|Procedure|management of therapy complications|
16336149|NCT00378937|Procedure|quality-of-life assessment|
16336150|NCT00378911|Drug|sunitinib malate|Given orally
16336151|NCT00378898|Device|BRAVO capsule|
16336152|NCT00378898|Procedure|Fluoroscopy|"one time xray to determine evacuation of bravo"
16336153|NCT00378898|Other|sham BRAVO capsule placement|
16336154|NCT00378885|Behavioral|Cognitive-behavioral tailored intervention|
16336155|NCT00378872|Drug|IV Tranexamic acid 10mg/kg pt body weight|
16336156|NCT00378872|Drug|Quixil topical sealant|
16336157|NCT00378859|Behavioral|Skim milk|
16336158|NCT00378859|Behavioral|Lean meat|
16336159|NCT00378846|Procedure|infrared thermography|
16336160|NCT00378833|Drug|niacin (+) laropiprant|Duration of Treatment: 18 Weeks
16336161|NCT00378833|Drug|niacin|Duration of Treatment: 18 Weeks
16336162|NCT00378820|Behavioral|Whey without milk minerals|
16336163|NCT00378820|Behavioral|Whey with milk minerals|
16336164|NCT00378820|Behavioral|Casein without milk minerals|
16336165|NCT00378820|Behavioral|Casein with milk minerals|
16336166|NCT00378781|Drug|Heparin|Heparin flush solution into CVC once daily.
16336167|NCT00378781|Drug|Minocycline-EDTA|M-EDTA flush solution into CVC once daily.
16336168|NCT00378768|Biological|anti-thymocyte globulin|
16336169|NCT00378755|Drug|velcade|
16336170|NCT00378729|Drug|Metformin and FSHr|treatment for infertility
16336171|NCT00378729|Procedure|Ovarian drilling by FERTILOSCOPY|surgical ovarian drilling
16336172|NCT00378716|Drug|5-fluorouracil|
16336173|NCT00378716|Drug|leucovorin calcium|
16336174|NCT00378716|Drug|tegafur|
16336175|NCT00378716|Drug|uracil|
16336176|NCT00378703|Biological|Bevacizumab|Given IV
16336177|NCT00378703|Other|Laboratory Biomarker Analysis|Correlative studies
16336178|NCT00378703|Other|Pharmacological Study|Correlative studies
16336179|NCT00378703|Drug|Sorafenib Tosylate|Given PO
16336180|NCT00378703|Drug|Temsirolimus|Given IV
16336181|NCT00378690|Drug|leuprorelin acetate|LHRH antagonist
16336182|NCT00378677|Drug|Cyclosporine A dry powder inhalation (Drug)|
16336183|NCT00378664|Procedure|lumbar to sacral ventral nerve re-routing procedure|surgical nerve re-routing procedure
16336184|NCT00378651|Procedure|Neck Auscultation|
16336185|NCT00378638|Drug|bevacizumab combined with dose dense chemotherapy|
16336186|NCT00378625|Drug|Artesunate|
16336187|NCT00378612|Device|Cypher sirolimus eluting coronary stent|Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.
16336188|NCT00378599|Drug|Combination of (a) pegylated interferon alfa-2b and (b) rebetol|"Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks"
16336189|NCT00378586|Procedure|Rectal biopsy|Rectal biopsy.
16336190|NCT00378586|Procedure|Measurement of inflammatory markers in the rectal mucosa|IL-6, TNF-alfa.
16336191|NCT00378586|Procedure|Measurement of rectal lactic acid|Equilibrium dialysis.
16336192|NCT00378573|Drug|docetaxel|
16336193|NCT00378573|Drug|gemcitabine|
16336194|NCT00378573|Drug|bevacizumab|
16336195|NCT00378560|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|V501; Gardasil, 0.5 ml injection in 3 dosing regimen
16336196|NCT00378560|Biological|Comparator: Placebo|Placebo 0.5 ml injection in 3 dosing regimen
16336197|NCT00378547|Drug|paracetamol + placebo + placebo|Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
16336198|NCT00378547|Drug|paracetamol + pregabalin + placebo|Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
16336199|NCT00378547|Drug|paracetamol + pregabalin + dexamethasone|Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
16336200|NCT00378534|Device|Miltenyi reagent system|Miltenyi Clinimax CD34 Reagent System for CD34 selection and delayed T cell depletion add back
16336201|NCT00378534|Drug|Fludarabine|Therapeutic
16336202|NCT00378534|Drug|Cyclosporine|Therapeutic
16336203|NCT00378534|Drug|Cyclophosphamide|Therapeutic
16336204|NCT00378534|Other|FILGRASTIM (G-CSF)|An HLA 6/6 identical family member will be co-enrolled into this study as a stem cell donor. Stem cell Donors will receive G-CSF for stem cell mobilization. The stem cell collection aspect of this protocol is not investigational.
16336205|NCT00378521|Drug|MQX-503|
16336206|NCT00378508|Drug|mAb hOKT3gamma1(Ala-Ala), Teplizumab|This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
16336207|NCT00378508|Drug|Placebo Arm|
16336208|NCT00378495|Drug|Miltefosine: initially 2.5 mg/kg/day for 28 days|
16336209|NCT00378482|Drug|CP-675,206 (Tremelimumab)|15 mg/kg IV every 3 months as long as required
16336210|NCT00378469|Behavioral|45 minute exercise on ergocycle|
16336211|NCT00378456|Drug|Antioxidants- (Vitamins A,C,E Selenium and Zinc)|
16336212|NCT00378456|Drug|Folinic acid|
16336213|NCT00378456|Drug|Vitamins A,C,E Selenium and Zinc and Folinic acid.|
16336214|NCT00378456|Drug|Placebo|
16336215|NCT00378443|Drug|prednisone + Inhibace/Cozaar|
16336216|NCT00378443|Drug|Inhibace/Cozaar|
16336217|NCT00378417|Biological|7-valent pneumococcal-CRM197 conjugate vaccine|
16336218|NCT00378417|Biological|7-valent pneumococcal-OMPC conjugate vaccine|
16336219|NCT00378404|Drug|Docetaxel|30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles
16336220|NCT00378404|Radiation|Radiation|50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles
16336221|NCT00378378|Drug|Mometasone Furoate Nasal Spray (MFNS)|100 mcg nasal spray
16336222|NCT00378378|Drug|Placebo nasal spray|One spray of placebo nasal spray in each nostril once daily for 4 months.
16336223|NCT00378365|Procedure|Arsenic trioxide|Arsenic trioxide
16336224|NCT00378365|Procedure|ATRA|ATRA
16336225|NCT00378352|Drug|Epoetin alfa|Randomized
16336226|NCT00378339|Device|gold berlocks|
16336227|NCT00378326|Drug|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
16336228|NCT00378313|Drug|gemcitabine, epirubicin, paclitaxel|
16336229|NCT00378300|Drug|Oral Probiotics|
16336230|NCT00378287|Drug|rabeprazole sodium|
16336231|NCT00378274|Behavioral|Observation|
16336232|NCT00378261|Procedure|Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.|
16336233|NCT00378248|Behavioral|Combined psychotherapy|18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
16336234|NCT00378248|Behavioral|Outpatient individual psychotherapy|Eclectic individual psychotherapy in private practice
16336235|NCT00378235|Drug|IL13-PE38QQR|
16336236|NCT00378222|Procedure|Autologous Stem Cell Transplantation|
16336237|NCT00378209|Drug|Bortezomib|Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
16336238|NCT00378209|Drug|Lenalidomide|Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
16336239|NCT00378209|Drug|Dexamethasone|Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
16336240|NCT00378196|Drug|Ranibizumab|0.3 mg/0.05 ml dose
16336241|NCT00378196|Drug|Ranibizumab|0.5 mg/0.05 ml dose
16336242|NCT00378183|Drug|risperidone|
16336243|NCT00378170|Device|intubation of patients undergoing elective surgery|
16336244|NCT00378157|Behavioral|Joint attention intervention|Eight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school.
16336245|NCT00378144|Drug|Pseudoephedrine/Paracetamol|Fixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)]
16336246|NCT00378131|Drug|RC-1291|
16336247|NCT00378131|Drug|placebo|
16336248|NCT00378118|Other|Abbott-rapid HIV antibody test|Abbott will be used to test serum or whole blood
16336249|NCT00378118|Other|OraQuick Rapid HIV-1/2 Antibody test|OraQuick for oral fluid HIV antibody testing
16336250|NCT00378105|Drug|Bortezomib|Intravenously on days 1, 4, 8 and 11 of a 21 day cycle for a minimum of 8 cycles (dosage will vary depending upon when the participant enters the trial)
16336251|NCT00378105|Drug|Lenalidomide|Taken orally twice a day for 2 weeks (days 1-14) of each 21-day cycle for a minimum of 8 cycles (dosage will vary depending upon when participant enters trial).
16336252|NCT00378105|Drug|dexamethasone|Taken orally on days 1,2,4,5,8,9,11 of a 21-day cycle for a minimum of 8 cycles.
16336253|NCT00378092|Drug|Oral risperidone|Oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits.
16336254|NCT00378092|Drug|Risperidone Long-Acting Injection (RLAI)|RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.
16336255|NCT00378092|Drug|Risperidone Long-Acting Injection (RLAI)|Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months.
16336256|NCT00378079|Other|Counseling Only|Counseling only in prison, with passive referral to drug abuse treatment upon release
16336257|NCT00378079|Drug|Counseling + Transfer|Counseling only in prison, with opportunity to enter methadone maintenance upon release
16336258|NCT00378079|Drug|Counseling + Methadone|Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
16336259|NCT00378066|Drug|Bevacizumab|Bevacizumab, Capecitabine, Oxaliplatin
16336260|NCT00378027|Drug|Fondaparinux|Administer Fondaparinux Risk Stratify
16336261|NCT00378014|Drug|everolimus|Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.
16336262|NCT00378014|Drug|basiliximab|All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
16336263|NCT00378014|Drug|CNI|Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
16336264|NCT00378001|Drug|FSH-IBSA|
16336265|NCT00378001|Drug|GONAL-F|
16336266|NCT00377988|Drug|Transdermal Contraceptive System|In each 4-week period, exposed subjects will wear a transdermal patch containing 6 mg norelgestromin and 0.75 mg EE worn for each of 3 consecutive weeks with no patch the 4th week.
16336267|NCT00377988|Drug|Norgestimate-containing oral contraceptives with EE|NGM-OCs with 34 mcg of EE taken during each 4 week period for 21 consecutive days, then no pill or a drug-free pill 7 days.
16336268|NCT00377975|Drug|Ephedrine|
16336269|NCT00377975|Drug|Pioglitazone|
16336270|NCT00377975|Drug|Caffeine|
16336271|NCT00377962|Drug|Everolimus|0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
16336272|NCT00377962|Drug|Mycophenolic acid (MPA)/azathioprine (AZA)|In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
16336273|NCT00377962|Drug|Calcineurin inhibitors (CNI)|Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
16336334|NCT00377442|Drug|Simvastatin|80mg po
16336557|NCT00375791|Drug|dexamethasone|20 mg twice weekly
16336274|NCT00377962|Drug|Steroids|Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.
16336275|NCT00377936|Drug|Gemcitabine alone|Gemcitabine monotherapy 1000 mg/m2 weekly
16336276|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
16336277|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
16336278|NCT00377936|Drug|EndoTAG-1 and Gemcitabine|EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
16336279|NCT00377923|Drug|Progesterone|
16336280|NCT00377910|Drug|Aethoxysclerol|2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
16336281|NCT00377897|Procedure|cell therapy|Injection of Bone-Marrow mononuclear cells in the muscles of the calf.
16336282|NCT00377871|Device|biological heart valve prosthesis|Two heart valve designs
16336283|NCT00377858|Drug|Insulin lispro mid mixture (MM)|Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
16336284|NCT00377858|Drug|Insulin glargine|Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
16336285|NCT00377845|Procedure|Regular Tampax used in 3 hours|
16336286|NCT00377832|Drug|Acetaminophen 975 mg|Acetaminophen 975 mg by mouth once only
16336287|NCT00377819|Drug|alendronate|70 mg oral QW
16336288|NCT00377819|Drug|Denosumab (AMG 162)|60 mg SC q 6 mos
16336289|NCT00377806|Drug|Diclofenac gel|
16336290|NCT00377793|Drug|Levitra (Vardenafil, BAY38-9456)|
16336291|NCT00377793|Drug|Placebo|
16336292|NCT00377780|Drug|Non pegylated liposomal doxorubicin, trastuzumab, docetaxel|max. 6 courses
16336293|NCT00377767|Behavioral|To change structure and roles of primary care teams to optimize prevention of obesity|
16336294|NCT00377741|Drug|valganciclovir [Valcyte]|900mg po
16336295|NCT00377728|Drug|GSK256066|
16336296|NCT00377715|Drug|Dimebon|
16336297|NCT00377715|Drug|Placebo|
16336298|NCT00377689|Behavioral|high intensity functional exercise|high intensity functional exercise
16336299|NCT00377676|Drug|Cycloset|Usual diabetes therapy plus Cycloset
16336300|NCT00377676|Drug|Usual Diabetes Therapy plus placebo|Placebo tablet taken orally once in the morning, beginning with one tablet daily, titrated up by 1 tablet each week to a maximum of 6 tablets daily
16336301|NCT00377663|Behavioral|AsthmaNet|The AsthmaNet Web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition.
16336302|NCT00377650|Device|Percutaneous thrombectomy|
16336303|NCT00377637|Drug|Mycophenolate mofetil (MMF)|Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
16336304|NCT00377637|Drug|Cyclophosphamide|"Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
~Dosing was started at 0.75 g/m^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m^2. The target dose was 1.0 g/m^2, but doses were titrated by 0.25 g/m^2 increments to maintain nadir leukocyte count between 2500-4000/mm^3."
16336305|NCT00377637|Drug|Azathioprine|2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
16336306|NCT00377637|Drug|Placebo to Azathioprine|Placebo capsules matching Azathioprine taken orally once a day.
16336307|NCT00377637|Drug|Placebo to Mycophenolate mofetil|Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
16336308|NCT00377637|Drug|Corticosteroid|Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
16336309|NCT00377624|Drug|sodium hyaluronate|
16336310|NCT00377611|Biological|Fluarix™|
16336311|NCT00377598|Drug|TAK-583|TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
16336312|NCT00377598|Drug|TAK-583|TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks
16336313|NCT00377598|Drug|TAK-583|TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks
16336314|NCT00377598|Drug|TAK-583|TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks
16336315|NCT00377598|Drug|Placebo|TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks
16336316|NCT00377585|Biological|Fluarix|
16336317|NCT00377585|Biological|adjuvanted influenza vaccine|
16336318|NCT00377572|Biological|omalizumab|Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
16336319|NCT00377572|Biological|omalizumab placebo|Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
16336320|NCT00377559|Drug|Non pegylated liposomal doxorubicin and docetaxel|max. 6 courses
16336321|NCT00377546|Drug|Nepafenac|
16336322|NCT00377546|Drug|Ketorolac LS, Bromfenac|
16336323|NCT00377533|Device|wheelchair rear anti-tip device|assistive device
16336324|NCT00377520|Drug|pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
16336325|NCT00377507|Dietary Supplement|catechin extracts|catechin extracts solution
16336326|NCT00377494|Biological|MVA-CSO Vaccine|
16336327|NCT00377494|Biological|PfCSP DNA (VCL-2510) Vaccine|
16336328|NCT00377481|Drug|darbepoetin alfa|30 micrograms sc weekly (2 doses)
16336329|NCT00377481|Drug|epoetin beta [NeoRecormon]|6000 IU sc weekly (2 doses)
16336330|NCT00377468|Drug|Delta9-Tetrahydrocannabinol|
16336331|NCT00377455|Drug|Bosentan|62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
16336332|NCT00377455|Drug|Placebo|62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
16336333|NCT00377442|Drug|GK Activator (2)|100mg po
16336335|NCT00377429|Drug|catumaxomab|Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
16336336|NCT00377416|Genetic|rAAV2-CB-hAAT Gene Vector|Participants will attend a 5-day inpatient visit, during which they will receive a series of injections consisting of one of four different doses of rAAV2-CB-hAAT.
16336337|NCT00377403|Drug|Acetaminophen|"Symptomatic treatment:
~Dose: 500mg every 4 to 6 hours for pain or fever"
16336338|NCT00377403|Drug|Amoxicillin|"Intervention drug:
~Dose: 500mg tid for 10 days"
16336339|NCT00377403|Drug|Dextromethorphan hydrobromide with guaifenesin|"Symptomatic treatment:
~Dose: 10mls every 4 to 6 hours for cough"
16336340|NCT00377403|Drug|Guaifenesin|"Symptomatic treatment:
~Dose: 600mg every 12 hours to thin secretions"
16336341|NCT00377403|Drug|Pseudoephedrine Sustained Action|"Symptomatic treatment:
~Dose: 120mg every 12 hours for nasal congestion"
16336342|NCT00377403|Drug|Saline spray (0.65%)|"Symptomatic treatment:
~Dose: 2 squeezes per nostril as needed for nasal congestion"
16336343|NCT00377390|Biological|Omalizumab|Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit, as a part of ICATA (ICAC-08, NCTNCT00377572).
16336344|NCT00377377|Drug|EP1572 (ghrelin agonist) oral and duodenal application|
16336345|NCT00377364|Drug|Drug: Acetaminophen, Drug: Placebo|Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days
16336346|NCT00377325|Drug|Cyclosporine|4 mg/Kg/day; daily; liquid form; 6 months
16336347|NCT00377312|Drug|Parathyroid Hormone (1-34)|PTH(1-34) IV given over a one week period
16336348|NCT00377299|Drug|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.
16336349|NCT00377299|Drug|Placebo|Placebo matching active medication in all other physical aspects
16336350|NCT00377286|Dietary Supplement|Glucosamine (a dietary supplement)|1500 mg in 16 oz lite lemonade, once per day for 6 months
16336351|NCT00377286|Other|16 oz lite lemonade|16 oz lite lemonade 1 time daily for 6 months
16336352|NCT00377273|Drug|fluorouracil cream 0.5%|
16336353|NCT00377260|Drug|amoxicillin-clavulanate|Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.
16336354|NCT00377260|Drug|Placebo|Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.
16336355|NCT00377247|Biological|autologous monocyte-derived dendritic cells (DC) transfected with DNA|The patients will receive 1 x 107 DC/vaccine delivered intranodally or perinodally to lymph nodes (LN) distant from the head and neck area (e.g., to inguinal LN)
16336356|NCT00377234|Drug|Risedronate|35mg po weekly for 12 weeks
16336357|NCT00377234|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 3 months
16336358|NCT00377208|Behavioral|Web-Based Intervention|"My Expert Doctor is a web-based program that helps patients to ask the right questions regarding specific tests and treatments during their doctor visits. Upon entering medication and treatment information into the web site, patients are provided with individualized feedback and recommended questions to ask their doctor."
16336359|NCT00377195|Radiation|Involved Field Radiotherapy|"The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions.
~Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days."
16336360|NCT00377182|Drug|Copegus|1000/1200mg po daily for 4 weeks
16336361|NCT00377182|Drug|PEGASYS|180 micrograms sc weekly for 4 weeks
16336362|NCT00377182|Drug|RO5024048 1500mg|1500mg po bid for 4 weeks
16336363|NCT00377182|Drug|RO5024048 3000mg|3000mg po bid for 4 weeks
16336364|NCT00377156|Radiation|radiation therapy|Patients undergo radiation therapy 5 days a week for 2.5 weeks
16336365|NCT00377156|Radiation|stereotactic radiosurgery|
16336366|NCT00377143|Drug|Warfarin Dosing|
16336367|NCT00377130|Other|Self Administered Stress Management|"The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The positive thinking exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training."
16336368|NCT00377117|Procedure|Management|
16336369|NCT00377117|Procedure|Screening|
16336370|NCT00377104|Drug|alvocidib|Given IV
16336371|NCT00377104|Other|pharmacological study|Correlative studies
16336372|NCT00377104|Other|laboratory biomarker analysis|Correlative studies
16336373|NCT00377091|Drug|Fondaparinux|
16336374|NCT00377078|Drug|recombinant human lactoferrin|
16336375|NCT00377065|Drug|raltegravir|raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks
16336376|NCT00377052|Drug|bortezomib|1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
16336377|NCT00377052|Drug|gemcitabine hydrochloride|1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks
16336378|NCT00377039|Drug|AD 337|
16336379|NCT00377026|Behavioral|lifestyle intervention|Lifestyle modification including individual sessions with an interventionist to discuss dietary intake and exercise. Group sessions with other participants randomized to the lifestyle intervention to discuss lifestyle modification and group exercise.
16336380|NCT00377000|Drug|clindamycin 1% / benzoyl peroxide 5% gel pump|
16336381|NCT00377000|Drug|clindamycin 1% / benzoyl peroxide 5% tube|
16336556|NCT00375791|Drug|perifosine|100 - 150 mg daily
16336382|NCT00376987|Dietary Supplement|zinc oxide|Oral daily dietary supplement containing 80 mg Zinc oxide
16336383|NCT00376974|Behavioral|American Academy of Ophthalmology Glaucoma Educational Tape|
16336384|NCT00376961|Biological|rituximab|375 mg/m^2 on day 1 for cycles 1-6.
16336385|NCT00376961|Drug|bortezomib|1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.
16336386|NCT00376961|Drug|cyclophosphamide|750 mg/m^2 on day 1 of cycles 1-6.
16336387|NCT00376961|Drug|doxorubicin hydrochloride|50 mg/m^2 on day 1 of cycles 1-6.
16336388|NCT00376961|Drug|prednisone|100 mg on days 1-5 of cycles 1-6.
16336389|NCT00376961|Drug|vincristine sulfate|1.4 mg/m^2 on day 1 of cycles 1-6.
16336390|NCT00376948|Dietary Supplement|genistein|
16336391|NCT00376948|Drug|erlotinib hydrochloride|
16336392|NCT00376948|Drug|gemcitabine hydrochloride|
16336393|NCT00376935|Drug|Palifermin|Keratinocyte growth factor administered via injection
16336394|NCT00376935|Drug|Palifermin placebo|Keratinocyte growth factor placebo administered via injection
16336395|NCT00376922|Procedure|music therapy|music played for patient during bone marrow biopsy collection
16336396|NCT00376909|Other|educational intervention|
16336397|NCT00376909|Other|study of socioeconomic and demographic variables|
16336398|NCT00376896|Drug|GW876008 200mcg|GW876008
16336399|NCT00376896|Drug|GW876008 20mcg|GW876008 20mcg
16336400|NCT00376896|Other|Placebo|placebo
16336401|NCT00376883|Drug|pamidronate|
16336402|NCT00376870|Drug|Pioglitazone|pioglitazone 30 mg/d
16336403|NCT00376870|Drug|Placebo|Placebo 30 mg/d
16336404|NCT00376857|Drug|Surgery with and without the aid of Indocyanine Green (ICG)|
16336405|NCT00376844|Radiation|External Beam Radiation Therapy|
16336406|NCT00376844|Radiation|Vaginal Brachytherapy|
16336407|NCT00376831|Drug|Midazolam, Fentanyl|fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
16336408|NCT00376831|Drug|KETAMINE, MIDAZOLAM|Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
16336409|NCT00376818|Behavioral|exercise intervention|All participants will convene once per week for 8 weeks for a 90-minute session that will be based on yoga principles for a stress reduction.
16336410|NCT00376818|Other|educational intervention|A 15-minute educational session on a particular topic (mind-body connection; fight or flight response; relaxation response; the science and philosophy of yoga; the science of meditation; sleeping well; mindfulness; the healer within - how to harness your innate healing potential).
16336411|NCT00376818|Other|physiologic testing|Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
16336412|NCT00376818|Other|management of therapy complications|Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
16336413|NCT00376818|Behavioral|mind-body intervention procedure|"Meditation practice in this study will consist of 15 minutes of body scan to completely relax the body from head to toe and will be followed by 15 minute silence during which the study participants will maintain awareness of their breath, bodily sensations and thoughts as they spontaneously arise. The remainder of the class will be devoted to a group discussion of personal reflections and challenges."
16336414|NCT00376818|Procedure|Measurement of stress-related hormones|Measurements of stress-related hormones: Stress hormones cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin will be measured in saliva because their levels in saliva accurately reflect blood levels (Carlson et al, 2004). The non-invasive saliva collection method by cotton swabs (Salivette® by Sardstedt Inc.) will be used in this study.
16336415|NCT00376805|Drug|Fludarabine|administered intravenously 25 mg/m^2 times 5 doses
16336416|NCT00376805|Drug|Cyclophosphamide|administered intravenously 60 mg/kg days times 2 doses.
16336417|NCT00376805|Radiation|Total body irradiation|200 cGy (gray) on day -1
16336418|NCT00376805|Other|Natural killer cell infusion|Infused cell dose is within the range of 1.5-8.0 x 10^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion.
16336419|NCT00376805|Biological|Interleukin-2|administered subcutaneously (10 MU) 3 times per week for 6 doses
16336420|NCT00376792|Drug|docetaxel|
16336421|NCT00376792|Other|active surveillance|
16336422|NCT00376792|Procedure|adjuvant therapy|
16336423|NCT00376779|Biological|Infanrix hexa Vaccine|
16336424|NCT00376766|Drug|levetiracetam|
16336425|NCT00376740|Drug|zoledronic acid|Zoledronic acid 4 mg IV every 6 months up to 2.5 years after the start of letrozole treatment.
16336426|NCT00376727|Biological|cetuximab|Dose level 0: cetuximab 400 mg/m2 week 1, 250 mg/m2 weekly; Dose level 1: cetuximab 400 mg/m2 week 1, 300 mg/m2 weekly; Dose level 2: cetuximab 400 mg/m2 week 1, 350 mg/m2 weekly; Dose level 3: cetuximab 400 mg/m2 week 1, 400 mg/m2 weekly
16336427|NCT00376727|Genetic|molecular diagnostic method|Tissue and Blood Specimens; IHC Methodology; IHC Scoring; K-RAS Mutation Analysis
16336428|NCT00376727|Other|immunologic technique|Peripheral Blood Mononuclear Cells (PBMC)
16336429|NCT00376727|Other|laboratory biomarker analysis|Cetuximab Pharmacodynamics
16336430|NCT00376714|Drug|GSK233705|
16336431|NCT00376701|Drug|Avastin (Bevacizumab)|Avastin 1.25 mg intravitreal
16336432|NCT00376701|Drug|Bevacizumab|Intravitreal 1.25 mg
16336433|NCT00376701|Drug|Bevacizumab|Intravitreal 1.25 mg
16336434|NCT00376701|Drug|Bevacizumab|Intravitreal Avastin 1.25 mg and sham reduced fluence PDT
16336435|NCT00376688|Other|Laboratory Biomarker Analysis|Correlative studies
16336436|NCT00376688|Drug|Temsirolimus|Given IV
16336437|NCT00376675|Drug|methylphenidate hydrochloride|Given orally
16336438|NCT00376675|Other|placebo|Given orally
16336439|NCT00376662|Drug|Hormone Replacement Therapy and Etidronate|
16336440|NCT00376649|Behavioral|lifestyle changing workshop|
16336441|NCT00376636|Drug|SPP635 (drug)|
16336442|NCT00376623|Drug|BI 2536|
16336443|NCT00376610|Device|ASR/Re-cap|
16336444|NCT00376597|Other|quality of life assessment|Ancillary studies
16336445|NCT00376597|Other|educational intervention|Receive lymphedema educational materials
16336558|NCT00375778|Drug|memantine (drug)|
16336446|NCT00376597|Procedure|Physical therapy|Complete physical therapy-focused intervention
16336447|NCT00376584|Drug|MK-0524A|
16336448|NCT00376584|Drug|ER Niacin|
16336449|NCT00376584|Drug|Placebo|
16336450|NCT00376571|Procedure|Percutaneous coronary intervention|"Comparing treatment of either no side branch treatment versus stenting of main vessel and side branch treatment"
16336451|NCT00376558|Behavioral|Community Reinforcement Approach|Community Reinforcement Approach (CRA): The community reinforcement treatment program will be carried out in accordance with NIDA's therapy manual (13).During weeks 13 through 24, patients will meet once per week with their therapists. Sessions will focus on promoting continued change in the life areas addressed in the first 12 weeks of treatment or new components are added as needed.
16336452|NCT00376519|Drug|cyclophosphamide|Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush and mesna (MT(S)9006) on day -8 and -7 one hour after fludarabine infusion.
16336453|NCT00376519|Drug|cyclosporine|Will be administered beginning on day -3 and adjusted to maintain a level of >200. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours.
16336454|NCT00376519|Drug|fludarabine phosphate|Fludarabine 25 mg/m^2/day will be administered as a 1 hour intravenous infusion on days -9 through -7.
16336455|NCT00376519|Drug|mycophenolate mofetil|All patients will begin mycophenolate mofetil (MMF) on day -3, at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).
16336456|NCT00376519|Procedure|Treg cell infusion|On day -1 prior to UCB transplantation, Treg cells will be infused IV without in-line filtration. A semi-log dose escalation of CD4+CD25+ Treg cells is scheduled with 3 patients at each step. Doses will be 0.1 x 10^6/kg, 0.3 x 10^6/kg, 1 x 10^6/kg and 3 x 10^6/kg weight (determined on the day prior to administration of the preparative therapy).
16336457|NCT00376519|Procedure|umbilical cord blood transplantation|Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. The UCB will be administrated by IV infusion without in-line filtration.
16336458|NCT00376519|Radiation|total-body irradiation|Radiotherapy: 165 cGy will be administered on day -5 through -2 two fractions each day.
16336459|NCT00376506|Device|Neurostimulation device for dysphagia|A neurostimulation device that is surgically implanted in the swallowing muscles.
16336460|NCT00376506|Device|External vibrotactile device|A vibrotactile device that is placed on the neck during swallowing.
16336461|NCT00376493|Drug|metronidazole and doxycycline|use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
16336462|NCT00376480|Biological|anti-thymocyte globulin|
16336463|NCT00376480|Biological|peripheral blood lymphocyte therapy|
16336464|NCT00376480|Drug|fludarabine phosphate|
16336465|NCT00376480|Drug|methylprednisolone|
16336466|NCT00376480|Drug|thiotepa|
16336467|NCT00376480|Procedure|allogeneic hematopoietic stem cell transplantation|
16336468|NCT00376480|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16336469|NCT00376480|Radiation|total-body irradiation|
16336470|NCT00376467|Drug|Imatinib|
16336471|NCT00376454|Drug|GW493838|
16336472|NCT00376441|Procedure|Vaginal Surgery|patients undergoing vaginal surgery
16336473|NCT00376428|Drug|Gentamicin|
16336474|NCT00376415|Drug|Lessertia Fructescens|Participants received 400mg lessertia fructescens leaf powder capsules twice daily for 3 months.
16336475|NCT00376415|Drug|Placebo|Participants received an identical placebo capsule twice daily for 3 months.
16336476|NCT00376402|Biological|H5N1 Pandemic Influenza Vaccine|
16336477|NCT00376376|Drug|levofloxacin at 250, 500, 750, and 1000 mg doses|
16336478|NCT00376363|Device|Ahmed implant|placement of glaucoma drainage device to control intraocular pressure
16336479|NCT00376363|Device|Baerveldt implant|placement of glaucoma drainage device to control intraocular press
16336480|NCT00376350|Procedure|Spinal Manipulation|5 minutes high velocity, low amplitude lumbar thrust
16336481|NCT00376350|Procedure|Light Massage|light pressure massage of the low back.
16336482|NCT00376350|Procedure|Pulsed Ultrasound|5 minutes pulsed ultrasound
16336483|NCT00376337|Drug|Micafungin|IV
16336484|NCT00376337|Drug|Systemic antifungal therapy|IV
16336485|NCT00376324|Drug|Tigecycline|Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.
16336486|NCT00376311|Drug|oral salmon calcitonin|
16336487|NCT00376285|Drug|CP-742,033|
16336488|NCT00376285|Drug|Fenofibrate|
16336489|NCT00376272|Drug|Valsartan|
16336490|NCT00376272|Drug|Placebo|
16336491|NCT00376259|Drug|telbivudine|600mg/day oral tablet for 96 weeks
16336492|NCT00376259|Drug|adefovir dipivoxil|10 mg of adefovir by mouth once daily
16336493|NCT00376246|Drug|Ezetimibe|
16336494|NCT00376220|Drug|Riluzole|Initially dispensed 50 mg capsules to take twice a day (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules in the morning (qAM), two capsules in the evening (qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as Montgomery Asberg Depression Rating Scale (MADRS) < 12) the dose will not be increased further unless clinical symptoms recur.
16336495|NCT00376220|Other|Placebo|Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
16336496|NCT00376207|Behavioral|Physical exercise|
16336497|NCT00376194|Drug|DMSA|
16336498|NCT00376181|Drug|Pioglitazone and Azilsartan|Pioglitazone 45 mg and Azilsartan 20 mg combination tablets, orally, once daily for up to 24 weeks.
16336499|NCT00376181|Drug|Pioglitazone and Azilsartan|Pioglitazone 45 mg and Azilsartan 40 mg combination tablets, orally, once daily for up to 24 weeks.
16336500|NCT00376181|Drug|Pioglitazone|Pioglitazone 45 mg, tablets, orally, once daily for up to 24 weeks.
16336501|NCT00376168|Drug|Plant cell expressed recombinant glucocerebrosidase (prGCD)|Intravenous infusion every two weeks for 9 months
16336502|NCT00376168|Drug|Plant cell expressed recombinant glucocerebrosidase (prGCD)|Intravenous infusion every 2 weeks for 9 months
16336503|NCT00376155|Drug|sulfadoxine /pyrimethamine plus amodiaquine|
16336504|NCT00376142|Behavioral|Psychological theory-based behaviour change interventions|
16336505|NCT00376129|Drug|Alefacept|15 mg i.m. once weekly for 12 weeks
16336506|NCT00376116|Device|Cardiac resynchronisation therapy|
16336507|NCT00376116|Device|Implantable cardioverter-defibrillator|
16336508|NCT00376103|Drug|temozolomide|75 mg/m2/day
16336509|NCT00376103|Procedure|Brachytherapy|60 Gy to 1 cm
16336510|NCT00376103|Procedure|External Beam Radiation Therapy|60 Gy
16336511|NCT00376090|Biological|MVA-CMDR|10^7 PFU IM, 1.0 mL
16336512|NCT00376090|Biological|Placebo|1.0 mL IM
16336513|NCT00376090|Biological|MVA-CMDR|10^6 PFU ID, 0.1 mL
16336514|NCT00376090|Biological|Placebo|0.1 mL ID
16336515|NCT00376090|Biological|MVA-CMDR|10^8 PFU IM, 1.0 mL
16336516|NCT00376090|Biological|MVA-CMDR|10^7 PFD ID, 0.1 mL
16336517|NCT00376077|Drug|Methylprednisolone and IVIG|Combination therapy (IV MP (Solu-Medrol®, Upjohn) 30 mg/kg (max. 1 g) over 1 hour followed by IVIG 1 g/kg (Gamunex Immune Globulin Intravenous [Human], 10%; Bayer)* x 1 dose
16336518|NCT00376077|Drug|Placebo and IVIG|Placebo followed by IVIG 1 g/kg (Gamunex Immune Globulin Intravenous [Human], 10%; Bayer)* x 1 dose
16336519|NCT00376064|Drug|Octreotide acetate and cabergoline/Octrotide and Somavert|
16336520|NCT00376051|Drug|Citalopram|Titrates from 10mg/day to 40mg/day, increases 10mg per week.
16336521|NCT00376038|Drug|GSK189075 oral tablets|
16336522|NCT00376038|Drug|metformin tablets|
16336523|NCT00376025|Dietary Supplement|Biological Antioxidant Supplementation|Supplementation of affected population with the Phytochemical antioxidant, Garcinia Mangostata in addition to sodium selenate.
16336524|NCT00376012|Drug|Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)|Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months.
16336525|NCT00376012|Drug|Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)|Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 7 months.
16336526|NCT00375999|Drug|Docetaxel and epirubicin|
16336527|NCT00375986|Procedure|Manual placental removal at Cesarean delivery|
16336528|NCT00375986|Procedure|Spontaneous placental removal at Cesarean delivery|
16336529|NCT00375973|Drug|Duloxetine|Duloxetine po 60-120 mg/day for 12 weeks
16336530|NCT00375973|Drug|Placebo|Sugar pill dose comparable to duloxetine
16336531|NCT00375960|Drug|V3381|
16336532|NCT00375960|Drug|Placebo|
16336533|NCT00375947|Other|Hand Exercise|
16336534|NCT00375947|Other|sham hand cream|placebo intervention
16336535|NCT00375934|Drug|diclofenac potassium (XP21L)|25 mg capsule, every 6 hours
16336536|NCT00375934|Drug|Placebo|Oral placebo capsule, every 6 hours
16336537|NCT00375895|Drug|ciclosporin|ciclosporin administered orally twice a day, at the initial dosing of 2.5 mg/kg/d, adjusted to obtain a C2 concentration of 600 ng/ml associated with the usual ribavirin and PEGinterferon bitherapy.
16336538|NCT00375882|Procedure|hypothermia|
16336539|NCT00375882|Procedure|cochlear implantation with mild hypothermia|
16336540|NCT00375869|Drug|Darbeopoetin|The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.
16336541|NCT00375869|Drug|Normal Saline (Placebo)|The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.
16336542|NCT00375856|Device|DePuy P.F.C.® Sigma Rotating Platform Knee|no details
16336543|NCT00375843|Drug|Escitalopram|Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
16336544|NCT00375843|Drug|Sertraline|Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
16336545|NCT00375830|Procedure|Bone scan|Scan to diagnose a number of bone conditions including cancer or metastasis
16336546|NCT00375830|Drug|99mTc-methyl diphosphonate|Radiolabel for bone scan procedures
16336547|NCT00375830|Procedure|Positron Emission Tomography (PET) scan|Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
16336548|NCT00375830|Drug|18F-Fludeoxyglucose (18F-FDG)|Radiolabel for positron emission tomography scan procedures
16336549|NCT00375830|Procedure|Computed Tomography (CT) scan|Scan to detect & analyze X-rays
16336550|NCT00375830|Drug|18F-Sodium Fluoride (18F-NaF)|Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.
16336551|NCT00375830|Procedure|Whole Body Magnetic Resonance Imaging (WB-MRI) scan|Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.
16336552|NCT00375830|Drug|Gadopentetate dimeglumine|A gadolinium-based contrast agent for MRI
16336553|NCT00375830|Drug|Gadofosveset|A gadolinium-based contrast agent for MRI
16336554|NCT00375830|Drug|Gadobutrol|A gadolinium-based contrast agent for MRI
16336555|NCT00375817|Procedure|Myoblasts injection with MyoCath catheter|
16336560|NCT00375752|Drug|Letrozole|2.5 mg.tablet.
16336561|NCT00375752|Drug|Zolendronic Acid|4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)
16336562|NCT00375739|Drug|PEP005|
16336563|NCT00375726|Biological|rDEN3/4delta30(ME)|Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
16336564|NCT00375726|Biological|Placebo|Placebo for rDEN3/4delta30(ME)
16336565|NCT00375713|Drug|Levocetirizine|1 Levocetirizine 5mg tablet per day before bedtime for 14 days
16336566|NCT00375713|Drug|Cetirizine|1 Cetirizine 10mg tablet per day before bedtime for 14 days.
16336567|NCT00375713|Drug|Placebo-Levocetirizine|1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
16336568|NCT00375713|Drug|Placebo-Cetirizine|1 Placebo-Cetirizine tablet per day before bedtime for 14 days
16336569|NCT00375713|Drug|Standard topical steroid (1% hydrocortisone) ointment|1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
16336570|NCT00375700|Dietary Supplement|Nutritional Supplement|
16336571|NCT00375687|Drug|Triptorelin|
16336572|NCT00375674|Drug|Sunitinib malate|sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
16336573|NCT00375674|Other|Placebo|Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
16336574|NCT00375661|Drug|interferon-alfa-2b and ribavirin|Interferon, pnce per week plus daily ribavirin
16336575|NCT00375648|Drug|Zoledronic acid|
16336576|NCT00375635|Procedure|mFPSA treatment|
16336577|NCT00375622|Drug|Tamoxifen|
16336578|NCT00375609|Drug|Betrixaban|Capsule
16336579|NCT00375609|Drug|Enoxaparin|Administered subcutaneously
16336580|NCT00375596|Drug|Ketotifen/vasoconstrictor|
16336581|NCT00375583|Drug|DEC/Albendazole|
16336582|NCT00375570|Drug|ME-609|Topical treatment 5 times daily for 5 days
16336583|NCT00375557|Drug|Divalproex ER|Divalproex ER will be initiated on 250 mg/day, dosed once daily. The daily dose of Divalproex ER will be titrated up 250 mg each day based on patients' response and tolerability, not to exceed a maximum of 2000 mg/day.
16336584|NCT00375557|Drug|Quetiapine|Quetiapine will be initiated in 25 mg/day, with a variable dosing frequency (QD-TID). The daily dose of Quetiapine will be titrated up by 25-50 mg each day based on patients' response and tolerability, not to exceed a maximum of 750 mg/day.
16336585|NCT00375544|Device|Low level light therapy|
16336586|NCT00375531|Behavioral|Mindfulness Meditation (MfM)|
16336587|NCT00375518|Drug|Atorvastatin|Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
16336588|NCT00375518|Drug|Placebo|Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
16336589|NCT00375505|Drug|Zoledronic acid|
16336590|NCT00375505|Drug|Placebo|Placebo
16336591|NCT00375492|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16336592|NCT00375492|Drug|placebo|subcutaneous injection, volume equivalent to exenatide dose, twice a day
16336593|NCT00375466|Drug|Tranexamic acid|Tranexamic acid 10 mg/kg as a bolus dose followed by an infusion of 1 mg/kg/hour. Bolus given before start of surgery, infusion continued during surgery.
16336594|NCT00375466|Drug|placebo|0.9% sodium chloride 10 mg/kg, as a bolus injection before surgery followed by 1 mg/kg/h as an infusion during surgery
16336595|NCT00375453|Drug|SH U04722|
16336596|NCT00375440|Drug|Tranexamic Acid|
16336597|NCT00375427|Drug|Zoledronic acid|Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
16336598|NCT00375414|Procedure|PEG-Gastropexy|
16336599|NCT00375401|Drug|CP-945,598 Treatment A|Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
16336600|NCT00375401|Drug|CP-945,598 Treatment B|Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
16336601|NCT00375401|Drug|Placebo|Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
16336602|NCT00375388|Drug|Metformin on top of intensive insulin therapy|
16336603|NCT00375375|Drug|Lactulose|
16336604|NCT00375362|Drug|Nitroderm patch|
16336605|NCT00375349|Procedure|Ultrasound to demonstrate existence of fatty liver|
16336606|NCT00375323|Drug|NovoSeven|
16336607|NCT00375310|Drug|Gemcitabine, Sorafenib|"Gemcitabine is given IV
~Sorafenib is given orally of varying doses:
~Sorafenib 200 mg po qd ( during combination therapy)
~Sorafenib 400 mg po qd ( during combination therapy)
~Sorafenib 400 mg po bid ( during combination therapy)"
16336608|NCT00375310|Procedure|Radiotherapy|1.8 Gy CTV daily for 5 weeks
16336609|NCT00375297|Drug|sildenafil|
16336610|NCT00375284|Drug|Pramipexole|
16336611|NCT00375271|Procedure|perioperative hemodynamic optimization protocol|
16336612|NCT00375258|Drug|Tranexamic acid|Loading dose of 1 gram then 1 gram by infusion over 8 hours
16336613|NCT00375258|Drug|Sodium Chloride 0.9%|Visual matched placebo
16336614|NCT00375245|Drug|Rapamycin (sirolimus)|Weekly oral doses, dose is assigned at the time of study entry
16336615|NCT00375245|Other|Grapefruit Juice|Daily oral doses starting during the second week on study.
16336616|NCT00375232|Drug|Administration of montelukast or placebo|
16336617|NCT00375219|Drug|Omacetaxine mepesuccinate|"Induction:
~1.25 mg/m^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response. Patients not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.
~Maintenance:
~1.25 mg/m^2 subcutaneously, twice daily for 7 consecutive days in a 28-day cycle, for up to 3 years."
16336618|NCT00375206|Biological|Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)|
16336619|NCT00375193|Drug|Amrubicin|Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
16336620|NCT00375167|Behavioral|Recovery Workbook Training (psychoeducational training)|The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.
16336621|NCT00375167|Behavioral|ACT as usual|Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
16336622|NCT00375154|Device|Noninvasive Positive-Pressure Ventilation (NPPV)|
16336623|NCT00375141|Device|Pulsed dye laser, Intense pulsed light|
16336624|NCT00375128|Biological|FP9-PP (FP9 polyprotein)|
16336625|NCT00375128|Biological|MVA-PP (Modified Virus Ankara polyprotein)|
16336626|NCT00375115|Drug|Sambucol|
16336627|NCT00375102|Procedure|Acupuncture|
16336628|NCT00375102|Behavioral|Relaxation Response|
16336629|NCT00375089|Other|Group 1|Individuals with Prader-Willi syndrome. Monitoring every 6 months.
16336630|NCT00375089|Other|Group 2|Individuals with Early-onset Morbid Obesity.
16336631|NCT00375076|Drug|enoxaparin|
16336632|NCT00375063|Procedure|Percutaneous Coronary Intervention|
16336633|NCT00375063|Procedure|Coronary Artery Bypass Grafting|
16336634|NCT00375050|Drug|Riluzole|
16336635|NCT00375050|Drug|Placebo|placebo
16336636|NCT00375037|Behavioral|feedback|
16336637|NCT00375037|Behavioral|Education|
16336638|NCT00375037|Other|usual care|
16336639|NCT00375024|Procedure|Patient Navigation|Inclusion of Patient Navigator in treatment plan.
16336640|NCT00375024|Procedure|Clinic Staff|Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.
16336641|NCT00374998|Biological|FP9-PP (FP9 polyprotein)|
16336642|NCT00374998|Biological|MVA-PP (Modified Virus Ankara polyprotein)|
16336643|NCT00374985|Drug|Docetaxel, Oxaliplatin|weekly doses
16336644|NCT00374985|Procedure|Radiotherapy|regular fractions
16336645|NCT00374959|Drug|ceftriaxone|
16336646|NCT00374959|Device|Endotracheal tube for aspiration of subglottic secretions.|
16336647|NCT00374946|Device|THA|
16336648|NCT00374933|Drug|Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI|"Prophylactic delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
16336649|NCT00374933|Drug|"Prophylactic delayed ADLI"|"Prophylactic ADLI after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
16336650|NCT00374933|Drug|"Prophylactic delayed activated donor lymphocyte infusion"|"Prophylactic delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation"
16336651|NCT00374920|Drug|MEM 1003|
16336652|NCT00374907|Drug|Saxagliptin|Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
16336653|NCT00374907|Drug|Placebo|Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
16336654|NCT00374907|Drug|Metformin (blinded)|Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
16336655|NCT00374907|Drug|Metformin (open-label)|Tablets, Oral, 500-1500 mg, as needed (starting in LT)
16336656|NCT00374894|Drug|2,3-dimercaptosuccinic acid|
16336657|NCT00374881|Drug|Morphine|Morphine
16336658|NCT00374881|Drug|Morphine|Morphine low dose
16336659|NCT00374881|Drug|Sorbitol+Phenylephrine|Sorbitol+Phenylephrine
16336660|NCT00374881|Drug|Sorbitol+Phenylephrine+Morphine|Sorbitol+Phenylephrine+Morphine
16336661|NCT00374881|Drug|Sorbitol low concentration+Phenylephrine+Morphine|Sorbitol low concentration+Phenylephrine+Morphine
16336662|NCT00374868|Drug|pemetrexed|"Phase 1: 300 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles (dose escalation: 300 mg/m^2, 400 mg/m^2, and 500 mg/m^2)
~Phase 2: phase 1 determined dose, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy"
16336663|NCT00374868|Drug|cisplatin|"Phase 1: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles
~Phase 2: 50 mg/m^2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy"
16336664|NCT00374855|Drug|PPAR alpha|
16336665|NCT00374855|Drug|Hydrochlorothiazide|
16336666|NCT00374855|Drug|Placebo|
16336667|NCT00374842|Biological|Fluarix™|GlaxoSmithKline Biologicals' licensed influenza vaccine
16336668|NCT00374842|Biological|GSK1247446A|Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
16336669|NCT00374829|Behavioral|An IT-based patient follow-up and reminder system|
16336670|NCT00374803|Drug|Mycophenolic Acid (Myfortic)|"Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
~Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
16336671|NCT00374790|Drug|Ferrous sulfate|
16336672|NCT00374777|Drug|zolpidem MR|oral
16336673|NCT00374777|Drug|nitrazepam|oral
16336674|NCT00374777|Drug|placebo|oral
16336675|NCT00374764|Drug|Risperidone|
16336676|NCT00374764|Behavioral|ABA|
16336677|NCT00374751|Drug|Samarium (153SM)|The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.
16336678|NCT00374738|Behavioral|Guided Imagery for Trauma (GIFT)|Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.
16336679|NCT00374725|Behavioral|Administration of probiotic (L. rhamnosus and L. acidophilus)|
16336680|NCT00374699|Drug|Velcade|
16336681|NCT00374686|Drug|Valganciclovir|
16336682|NCT00374673|Device|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months
16336683|NCT00374660|Drug|Irofulven + oxaliplatin|"Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. Starting dose 40 mg/m^2, dose escalation 50, 60, 70, and 80 mg/m^2 every 28 days if no dose-limiting toxicity.
~Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered in a 30-minute infusion on Days 1 and 15 of a 28-day cycle. Starting dose 0.30 mg/kg, dose escalation to 0.40 mg/kg every 28 days if no dose-limiting toxicity."
16336684|NCT00374647|Drug|mycophenolate mofetil|
16336685|NCT00374647|Drug|sirolimus|
16336686|NCT00374634|Drug|rFSH drug dose|"Individual rFSH dose (50, 75 or 100 IU rFSH/day)"
16336687|NCT00374634|Drug|"Standard rFSH dose"|"Standard rFSH dose was 75 IU/day"
16336688|NCT00374621|Drug|Misoprostol with or without isosorbide mononitrate|Misoprostol 50 micrograms orally then 100 micrograms every 4 hours for up to four doses until modified Bishop score of 8 or higher was observed vs. the same misoprostol dosing plus isosorbide mononitrate 40 mg vaginally every 6 hours up to two doses total until a modified Bishop sore of at least 8 was observed
16336689|NCT00374582|Device|Bodystat Quadscan 4000|device determining body composition and nutritional status
16336690|NCT00374582|Device|bodystat quadscan 400|device determining body composition and nutritional status
16336691|NCT00374569|Procedure|Gymnastic Routine|A combination of gymnastic movements are performed
16336692|NCT00374556|Drug|Placebo|3mg placebo capsule, once daily at bedtime
16336693|NCT00374556|Drug|Eszopiclone|3mg capsule, once daily at bedtime
16336694|NCT00374543|Drug|Ziprasidone|Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
16336695|NCT00374543|Drug|Placebo|Placebo administered daily for 8 weeks
16336696|NCT00374530|Drug|PGE2|
16336697|NCT00374517|Drug|Pimonidazole hydrochloride|
16336698|NCT00374478|Drug|Scopolamine|
16336699|NCT00374465|Drug|Verapamil|
16336700|NCT00374465|Drug|Carvedilol|
16336701|NCT00374452|Other|ATHENA-CDS-HTN plus Guideline Link|ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
16336702|NCT00374452|Other|Guideline Link Only|Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.
16336703|NCT00374439|Behavioral|Cognitive-behavioral|Cognitive-behavioral approach
16336704|NCT00374439|Behavioral|Interpersonal Therapy|Interpersonal therapy approach
16336705|NCT00374426|Drug|sertraline|
16336706|NCT00374413|Device|Artificial disk|Implant
16336707|NCT00374413|Device|Artificial disc|Implant
16336708|NCT00374387|Drug|Nuvaring|
16336709|NCT00374387|Drug|low-dose combination pill|
16336710|NCT00374387|Drug|minipill|
16336711|NCT00374374|Behavioral|Administration of probiotic|
16336712|NCT00374348|Drug|Aripiprazole|Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
16336713|NCT00374335|Procedure|abdominal ultrasound|abdominal ultrasound to detect hepatic hemangiomas
16336714|NCT00374335|Other|Dermatologic Examination|Complete dermatologic examination
16336715|NCT00374322|Drug|lapatinib|Lapatinib 1500 mg (6 tablets) daily for 12 months
16336716|NCT00374322|Other|placebo|6 tablets daily for 12 months
16336717|NCT00374309|Drug|VRC-EBOADV018-00-VP|
16336718|NCT00374296|Drug|MGCD0103|MGCD0103 administered orally three-times per week
16336719|NCT00374270|Behavioral|Lifestyle Counselling; Opinion Leader Influence Statements|
16336720|NCT00374257|Procedure|Narrow-Band UVB Phototherapy|Performed either two or three times per week for a total of 24 treatments
16336721|NCT00374244|Drug|Pimozide|half of the subjects are randomized to the active drug group
16336722|NCT00374244|Drug|placebo|half of the subjects are randomized to placebo group
16336723|NCT00374231|Drug|tacrolimus|Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
16336724|NCT00374231|Drug|mycophenolate mofetil|Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
16336725|NCT00374231|Drug|Prednisone|Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
16336726|NCT00374218|Drug|High Fructose Corn Syrup|
16336727|NCT00374218|Drug|Sucromalt|
16336728|NCT00374205|Drug|Artesunate plus Amodiaquine|Artesunate 50 mg and Amodiaquine 153 mg co-blister tablets: 3 days once daily weight-adjusted dosing according to manufacturer
16336729|NCT00374205|Drug|Artemether-Lumefantrine|Artemether 20 mg/Lumefantrine 120mg fixe-dose-combination tablets: 3 days twice daily weight-adjusted dosing according to manufacturer
16336730|NCT00374192|Drug|Eszopiclone|3 mg per day
16336731|NCT00374192|Drug|Placebo|Placebo
16336732|NCT00374179|Drug|CT-322|IV solution, weekly or bi-weekly
16336733|NCT00374166|Drug|SSR149415|Oral administration (capsules of 50 and 100 mg)
16336734|NCT00374166|Drug|Placebo|Oral administration (capsules)
16336735|NCT00374166|Drug|Paroxetine|Oral administration (capsules)
16336736|NCT00374153|Behavioral|Feedback|Online personal feedback report
16336737|NCT00374153|Behavioral|Motivational Interview with Feedback|In-person Motivational Interview with personal feedback report
16336738|NCT00374153|Behavioral|Motivational Interview|In-person Motivational Interview only (without a personal feedback report)
16336739|NCT00374140|Drug|RAD001 (everolimus)|10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
16336740|NCT00374127|Drug|Marijuana blunt|Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).
16336741|NCT00374127|Drug|marijuana cigarette|Marijuana cigarettes were provided by the National Institute on Drug Abuse.
16336742|NCT00374114|Procedure|cervical conization|
16336743|NCT00374114|Procedure|ultrasonic surgical aspiration of the cervix|
16336744|NCT00374101|Drug|omeprazole|
16336745|NCT00374101|Drug|pantoprazole|
16336746|NCT00374088|Drug|N-acetylcysteine|"Loading dose: Subjects randomized to IV NAC will receive a total loading dose of 100 mg/kg of 10% (100 mg/mL) solution. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the loading dose will be 1 mL/kg, anticipated to be 2.5-5 mL in our patient population. The loading dose will be administered over 1 hr beginning 1 hr prior to the patient's OR time. Subjects in the placebo group will receive 1 mL/kg of D5W over 1 hr.
~Maintenance infusion: Subjects randomized to IV NAC will receive an infusion of 10 mg/kg/hr of 10% (100 mg/mL) solution for 24 hrs, starting in the OR after weaning from CPB. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the maintenance infusion will be 0.1 mL/kg/hr, anticipated to be 0.25-0.5 mL/hr in our patient population. Subjects in the placebo group will receive 0.1 mL/kg/hr of D5W for 24 hrs."
16336747|NCT00374088|Drug|Placebo|D5W bolus prior to surgery and D5W infusion after surgery in an equal volume to the drug arm.
16336748|NCT00374075|Drug|Valproic Acid|
16336749|NCT00374062|Behavioral|relaxation therapy 1|relaxation therapy 1
16336750|NCT00374062|Behavioral|relaxation therapy 2|relaxation therapy 2
16336751|NCT00374062|Behavioral|relaxation therapy 3|relaxation therapy 3
16336752|NCT00374049|Drug|MUC_1|Pretreatment with Poly-ICLC alone week 1 &2 (50 ug/kg 3 days/week) Weeks 3-7 Poly-ICLC, 2 days/week; MUC-1 vaccine (100ug) admixed with GM-CSF (100ug), administered subcutaneously at weeks 3, 5 and 7 Tetanus toxoid, administered via intramuscular injection, 1x at week 3 GM-CSF 100ug, administered subcutaneously on days 2-4
16336753|NCT00374036|Drug|ECC|capecitabine
16336754|NCT00374036|Drug|FOLFIRI|Irinotecan
16336755|NCT00374023|Drug|Zinc, or Vitamin A or both|
16336756|NCT00374010|Behavioral|Patient-Centered Advance Care Planning|"The PC-ACP is a scheduled interview with the dyad, delivered by a trained nurse facilitator. It consists of 5 stages and lasts about an hour:
~Representational assessment (10 - 15 minutes);
~Exploring concerns related to planning for future medical decision-making (10 - 15 minutes);
~Creating conditions for conceptual change (5 minutes);
~Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and
~Summary (3 - 5 minutes)"
16336757|NCT00373997|Procedure|Esophageal and Laryngeal biopsies|one day procedure
16336758|NCT00373997|Procedure|egd with biopsy|standard of care procedure with biopsy
16336759|NCT00373971|Behavioral|Involving the patients in their own nutritional care|
16336760|NCT00373958|Biological|13 valent pneumococcal conjugate vaccine|1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
16336761|NCT00373958|Biological|7vPnc pneumococcal conjugate vaccine|1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
16336762|NCT00373945|Drug|Observational Study|
16336763|NCT00373932|Behavioral|Coached exercise persistence intervention|Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.
16336764|NCT00373932|Behavioral|Self-Monitored exercise persistence intervention|Self-monitoring of symptoms and exercise using a mobile device
16336765|NCT00373919|Drug|intravenous (IV) administration of erythromycin|
16336766|NCT00373906|Drug|Bortezomib (Velcade)|
16336767|NCT00373893|Drug|Lidoderm Patch|
16336768|NCT00373880|Drug|Aripiprazole + Cocaine|Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
16336769|NCT00373880|Drug|Placebo + Cocaine|Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
16336770|NCT00373867|Behavioral|Standard physical therapy|Treatment-based classification physical therapy
16336771|NCT00373867|Behavioral|Graded exercise|Graded exercise increases an individual's tolerance to activity over time
16336772|NCT00373867|Other|Graded exposure|Graded exposure places the individual in fearful situations and gradually increases their exposure to such situations.
16336773|NCT00373815|Drug|Everolimus|
16336774|NCT00373802|Drug|Phenylephrine|
16336775|NCT00373789|Drug|Botulinum Toxin A, bladder detrusor muscle injection|200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.
16336776|NCT00373789|Drug|Vehicle saline as placebo|A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices
16336777|NCT00373776|Drug|miltefosine 2.5 mg/kg/day for 28 days|
16336778|NCT00373763|Procedure|Fetoscopic tracheal balloon occlusion|
16336779|NCT00373750|Procedure|Family Spirit Intervention|The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.
16336780|NCT00373724|Procedure|radiofrequency denervation|
16336781|NCT00373711|Drug|Iodine-124|2 mCi, oral
16336782|NCT00373711|Drug|Iodine-123|2 mCi, oral
16336783|NCT00373711|Drug|F-18 FDG|10-15 mCi, iv
16336784|NCT00373698|Behavioral|Three Component Model of Collaborative Care|Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
16336785|NCT00373685|Drug|Celecoxib|open-label
16336786|NCT00373685|Drug|Any commercially available NSAID with the indication for osteoarthritis|dosing as per USPI label related to the chosen commercially marketed NSAID
16336787|NCT00373672|Drug|armodafinil (Nuvigil)|armodafinil (Nuvigil)150 mg qd
16336788|NCT00373672|Drug|placebo|identical in appearance to active comparator
16336789|NCT00373659|Drug|Ranibizumab (Lucentis)|
16336790|NCT00373646|Drug|Thalidomide, Pharmion|200 mg p.o. daily
16336791|NCT00373633|Procedure|Thoracic Epidural|Gold standard for post thoracotomy pain
16336792|NCT00373633|Procedure|Extrapleural Intercostal Catheter|Continuous extra-pleural intercostal local anesthesia
16336793|NCT00373620|Drug|paclitaxel|
16336851|NCT00373191|Genetic|protein analysis|laboratory analysis
16336794|NCT00373607|Drug|Dihydroartemisin-piperaquine|Dihydroartemisin-piperaquine (Artekin) manufactured by Hualijian Pharmaceutical Co. Ltd., Guangzhou, China. Each tablet contains 40mg of dihydroartemisinin and 320mg piperaquine
16336795|NCT00373607|Drug|Mefloquine + Artesunate|Mefloquine + Artesunate (MAS3). The regimen is artesunate 4 mg/kg/day once daily for 3 days plus mefloquine 24 mg/kg given as a three day regimen of 8mg/kg/day
16336796|NCT00373594|Drug|Rituximab|
16336797|NCT00373594|Drug|Fludarabine|
16336798|NCT00373581|Drug|Vigabatrin|
16336799|NCT00373581|Drug|Cocaine|
16336800|NCT00373568|Drug|miltefosine: 2.5 mg/kg/day for 42 days|
16336801|NCT00373555|Procedure|Bronchoscopy|
16336802|NCT00373542|Drug|ropinirole CR-RLS|
16336803|NCT00373529|Drug|clofarabine|"Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.
~Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days."
16336804|NCT00373516|Drug|Vehicle (Placebo) applied BID|
16336805|NCT00373516|Drug|QRX-101 75 mcg/g ointment applied QD|
16336806|NCT00373516|Drug|QRX-101 75 mcg/g ointment applied BID|
16336807|NCT00373503|Drug|Lofexidine|alpha 2 adrenergic agonist, hypothesized to decrease noradrenergic activity
16336808|NCT00373503|Drug|dronabinol|cannabinoid agonist hypothesized to decrease MJ withdrawal
16336809|NCT00373503|Drug|Marijuana|marijuana intoxication, withdrawal and relapse assessed
16336810|NCT00373490|Drug|Vorinostat|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
16336811|NCT00373490|Drug|Vorinostat|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
16336812|NCT00373477|Procedure|Generalist Care Manager vs Usual Care|
16336813|NCT00373464|Drug|etoricoxib|
16336814|NCT00373451|Drug|Abciximab + UFH|Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute [maximum of 10 µg/minute] infusion for 12 hours)
16336815|NCT00373451|Drug|Bivalirudin|Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure)
16336816|NCT00373451|Drug|Heparin|i.v. bolus of 70 units/kg/body weight of unfractionated heparin
16336817|NCT00373438|Procedure|Fetoscopic tracheal balloon occlusion|Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes
16336818|NCT00373425|Drug|Erlotinib|150 mg tablet
16336819|NCT00373425|Drug|Placebo|Placebo tablet
16336820|NCT00373412|Biological|VCL CT02 pDNA vaccine|
16336821|NCT00373412|Biological|Towne CMV vaccine|
16336822|NCT00373399|Drug|Inactive Marijuana (0% THC)|Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
16336823|NCT00373399|Drug|Low THC marijuana (1.8 %THC)|Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
16336824|NCT00373399|Drug|High THC marijuana (3.9% THC)|Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
16336825|NCT00373386|Drug|growth hormone|Growth Hormone treatment
16336826|NCT00373373|Drug|Sorafenib|2 x 400 mg/d
16336827|NCT00373373|Drug|Placebo|Chemotherapy + Placebo
16336828|NCT00373360|Drug|treprostinil sodium|rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
16336829|NCT00373334|Drug|nizatidine (axid)|nizatidine (axid)
16336830|NCT00373334|Drug|nizatidine (axid)|nizatidine (axid)
16336831|NCT00373334|Drug|placebo|placebo
16336832|NCT00373295|Drug|Baclofen|Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
16336833|NCT00373295|Drug|Marijuana|Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
16336834|NCT00373295|Drug|Placebo|
16336835|NCT00373282|Drug|Triamcinolone acetonide|
16336836|NCT00373256|Drug|Sunitinib|Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
16336837|NCT00373256|Drug|paclitaxel|Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
16336838|NCT00373256|Drug|bevacizumab|Bevacizumab 10 mg/kg IV every 2 weeks.
16336839|NCT00373256|Drug|paclitaxel|Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
16336840|NCT00373243|Drug|GW406381|GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.
16336841|NCT00373230|Behavioral|telemedicine|One year behavioral modification weight control program comparing in-person consultations (monthly) to a computer based telemedicine system (available 24/7).
16336842|NCT00373217|Biological|MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine|Given intradermally or subcutaneously
16336843|NCT00373217|Biological|tetanus toxoid helper peptide|Given intradermally or subcutaneously
16336844|NCT00373217|Drug|carboplatin|Given IV
16336845|NCT00373217|Drug|paclitaxel|Given IV
16336846|NCT00373217|Procedure|conventional surgery|Patients undergo primary optimal cytoreductive surgery
16336847|NCT00373204|Drug|Motexafin Gadolinium|"On Day 1 of each 3 week cycle for up to 12 cycles:
~MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour."
16336848|NCT00373191|Drug|chemotherapy|N/A- not dictated by study
16336849|NCT00373191|Drug|endocrine therapy|N/A- not dictated by study
16336850|NCT00373191|Genetic|DNA methylation analysis|laboratory analysis
16336852|NCT00373191|Other|laboratory biomarker analysis|laboratory analysis
16336853|NCT00373191|Other|questionnaire administration|questionnaire
16336854|NCT00373191|Procedure|adjuvant therapy|N/A- not dictated by study
16336855|NCT00373191|Procedure|conventional surgery|N/A- not dictated by study
16336856|NCT00373191|Radiation|radiation therapy|N/A- not dictated by study
16336857|NCT00373178|Drug|rosiglitazone|
16336858|NCT00373178|Drug|metformin|
16336859|NCT00373178|Drug|Anti-diabetic medications|
16336860|NCT00373165|Drug|Ganciclovir|
16336861|NCT00373152|Procedure|Lumpectomy|Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
16336862|NCT00373152|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.
16336863|NCT00373152|Procedure|radiofrequency ablation|RFA is accomplished by placing a multi-array needle within a tumor. The tines of the needle are advanced and opened like an inverted umbrella. High frequency, alternating current moves from the tip of an electrode into the surrounding tissue. Oscillating ions generate frictional heat within the tumor. Cell death occurs at sustained temperatures above 45-50 degrees C. The multi-array configuration creates an egg-shaped ablation zone up to 5 cm in diameter.
16336864|NCT00373152|Radiation|gadopentetate dimeglumine|Injected at baseline MRI and post radiofrequency ablation MRI.
16336865|NCT00373126|Drug|transdermal nicotine patch|
16336866|NCT00373113|Drug|Capecitabine|1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
16336867|NCT00373113|Drug|Sunitinib malate|37.5 mg daily, continuous dosing
16336868|NCT00373100|Drug|Zinc acetate|
16336869|NCT00373100|Drug|Placebo|Placebo
16336870|NCT00373087|Drug|entacapone|entacapone
16336871|NCT00373087|Drug|l dopa versus placebo|l dopa versus placebo
16336872|NCT00373074|Other|Epidural Blood Patch|Use 15 cc of blood
16336873|NCT00373074|Other|Epidural Blood Patch|Inject 20 cc of blood into epidural space
16336874|NCT00373074|Other|Epidural Blood Patch|Inject 30 cc of autologous blood
16336875|NCT00373061|Drug|Xolair®|This being an observational study, the study protocol does not specify any dose regimen.
16336876|NCT00373048|Drug|mefloquine|tablet, once weekly
16336877|NCT00373048|Drug|placebo|tablet, once weekly
16336878|NCT00373035|Genetic|proteomic profiling|
16336879|NCT00373035|Other|immunological diagnostic method|
16336880|NCT00373035|Other|laboratory biomarker analysis|
16336881|NCT00373035|Other|mass spectrometry|
16336882|NCT00373035|Procedure|biopsy|
16336883|NCT00373035|Procedure|ultrasound imaging|
16336884|NCT00373022|Behavioral|exercise intervention|
16336885|NCT00373022|Other|flow cytometry|
16336886|NCT00373022|Other|laboratory biomarker analysis|
16336887|NCT00373022|Procedure|management of therapy complications|
16336888|NCT00373022|Procedure|psychosocial assessment and care|
16336889|NCT00373022|Procedure|quality-of-life assessment|
16336890|NCT00373009|Behavioral|Traditional Army training|As usual training for Soldiers
16336891|NCT00373009|Behavioral|Core stabilization exercise only|Core stabilization exercise
16336892|NCT00373009|Behavioral|Psychosocial education class only|Psychosocial education class
16336893|NCT00373009|Behavioral|Core stabilization and psychosocial education|Includes both core stabilization training and psychosocial education class
16336894|NCT00372996|Drug|CP-751,871|CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
16336895|NCT00372996|Drug|exemestane|Exemestane given at 25 mg orally once a day.
16336896|NCT00372996|Drug|exemestane|Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
16336897|NCT00372996|Drug|Fulvestrant|Used for salvage therapy and administered according to the local label and standard clinical practice.
16336898|NCT00372983|Drug|NOV-205|
16336899|NCT00372970|Drug|Botulinum toxin A|200 U given by injection into the pylorus.
16336900|NCT00372970|Drug|Placebo|saline injection into pylorus.
16336901|NCT00372957|Drug|GW823093 15mg|White opaque capsule containing 15mg of GW823093 as free base
16336902|NCT00372957|Drug|GW823093 placebo capsule|Matching placebo of GW823093 capsule or 15mg capsule
16336903|NCT00372957|Drug|GW823093 30mg|White opaque capsule containing 15mg of GW823093 as free base
16336904|NCT00372944|Drug|AZD6244|oral capsule
16336905|NCT00372944|Drug|capecitabine|oral tablet
16336906|NCT00372931|Drug|AL-37807|
16336907|NCT00372918|Procedure|Transnasal Esophagoscopy|fiberoptic exam of esophagus thru nares
16336908|NCT00372905|Drug|rituximab|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
16336909|NCT00372905|Drug|bortezomib|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
16336910|NCT00372905|Drug|Ibritumomab tiuxetan|Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
16336911|NCT00372892|Drug|Rituximab|375mg/m2 per week for 4 consecutive weeks
16336912|NCT00372892|Drug|Placebo|Saline IV placebo once per week for 4 consecutive weeks
16336913|NCT00372879|Dietary Supplement|Vitamin E|Vitamin E 800IU bid
16336914|NCT00372853|Drug|CP-675,206|CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
16336915|NCT00372853|Drug|SU011248|SU011248 administered at a dose of 37.5mg/day every day.
16336916|NCT00372853|Drug|CP-675,206|CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
16336917|NCT00372853|Drug|SU011248|SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
16336918|NCT00372840|Other|educational intervention|
16336919|NCT00372840|Procedure|psychosocial assessment and care|
16336920|NCT00372840|Procedure|quality-of-life assessment|
16336921|NCT00372827|Drug|Brinzolamide 1% added to Travoprost 0.004%|
16336922|NCT00372814|Behavioral|Intensive Home-Based Family Therapy|Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
16336923|NCT00372814|Behavioral|Supportive Telephone Calls|Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
16336924|NCT00372801|Drug|Ibuprofen|
16336925|NCT00372788|Drug|AZD6244|oral vial
16336926|NCT00372788|Drug|Pemetrexed|oral
16336927|NCT00372775|Drug|Sunitinib|Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
16336928|NCT00372762|Drug|Furosemide|Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover
16336929|NCT00372762|Drug|Bumetanide|Equivalent dose to pre-existing furosemide will be used
16336930|NCT00372762|Drug|furosemide|20mg to 80mg orally once or twice daily
16336931|NCT00372762|Drug|bumetanide|0.5mg to 2mg orally once or twice daily
16336932|NCT00372749|Behavioral|Aversive reaction during alcohol cue exposure|Aversive reaction during alcohol cue exposure
16336933|NCT00372736|Drug|AEG35156|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
16336934|NCT00372736|Drug|docetaxel|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
16336935|NCT00372736|Genetic|protein expression analysis|Cycle 1: Pre-dose on Days -2, 1, 8 and 15; repeat every 2-4 days if LFTs > 5 x ULN1 Cycle 2: Prior to each infusion; repeat every 2-4 days if LFTs > 5 x ULN1
16336936|NCT00372736|Genetic|reverse transcriptase-polymerase chain reaction|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
16336937|NCT00372736|Other|flow cytometry|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
16336938|NCT00372736|Other|immunoenzyme technique|Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
16336939|NCT00372736|Other|immunohistochemistry staining method|The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
16336940|NCT00372736|Other|laboratory biomarker analysis|The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
16336941|NCT00372723|Drug|Remicaide (infliximab)|a single dose infusion of 5mg/kg Remicade (Infliximab)
16336942|NCT00372710|Drug|Zoledronic acid|
16336943|NCT00372697|Drug|Octreotide acetate 30 mg suspension|Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.
16336944|NCT00372684|Genetic|with severe malaria hospitalized in ICU|with severe malaria hospitalized in ICU
16336945|NCT00372684|Genetic|with uncomplicated malaria|with uncomplicated malaria
16336946|NCT00372671|Behavioral|Survey|
16336947|NCT00372671|Behavioral|Survey and videotape|
16336948|NCT00372658|Drug|1% Lidocaine intracervical injection|
16336949|NCT00372645|Dietary Supplement|Folic acid (supplement)|200 µg folate per day from supplemental folic acid
16336950|NCT00372645|Dietary Supplement|Metafolin (supplement)|200 µg folate per day from supplemental Metafolin®
16336951|NCT00372645|Drug|Placebo|Placebo
16336952|NCT00372645|Other|Folate rich foods|200 µg folate per day from folate-rich foods
16336953|NCT00372632|Drug|Sulfadoxine-Pyrimethamine|The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
16336954|NCT00372632|Drug|placebo|The control group receives placebo similar in taste and appearance to to the experimental arm
16336955|NCT00372619|Drug|clofarabine|Given IV for 5 days
16336956|NCT00372619|Drug|cytarabine|Given IV
16336957|NCT00372619|Drug|methotrexate|Given intrathecally or IT age based dosage
16336958|NCT00372619|Other|laboratory biomarker analysis|
16336959|NCT00372606|Behavioral|Online MiDieta Diet and Weight Management Program for Hispanics|
16336960|NCT00372593|Drug|asparaginase|Given intramuscularly
16336961|NCT00372593|Drug|cytarabine|Given IV
16336962|NCT00372593|Drug|daunorubicin hydrochloride|Given IV over 6 hours
16336963|NCT00372593|Drug|etoposide|Given IV over 1-4 hours
16336964|NCT00372593|Drug|gemtuzumab ozogamicin|Given IV over 2 hours
16336965|NCT00372593|Drug|mitoxantrone hydrochloride|Given IV over 1 hour
16336966|NCT00372580|Procedure|blood test|
16336967|NCT00372567|Drug|sunitinib malate|37.5 mg daily
16336968|NCT00372567|Drug|imatinib mesylate|800mg daily
16336969|NCT00372541|Drug|ceftriaxone|
16336970|NCT00372528|Drug|pregabalin (LYRICA)|150 mg up to a maximum of 600 mg per day bid or tid as required
16336971|NCT00372515|Drug|Gefitinib|On days 1-14 gefitinib will be taken orally daily at either 750, 1000, or 1250mg (depends upon when subject entered trial). If medication is tolerated well, subject will take 500mg daily on days 15-28 of each 28-day cycle. Cycles (higher dose followed by lower dose) will be repeated as long as subject's cancer does not worsen and they do not experience any serious side effects.
16336972|NCT00372502|Procedure|Modified EGDT|Early goal directed therapy with lactate clearance
16336973|NCT00372502|Procedure|Standard EGDT|Early goal directed therapy
16336974|NCT00372489|Drug|peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
16336975|NCT00372476|Drug|Imatinib and Vinorelbine|
16336976|NCT00372463|Behavioral|6-week Online Diabetes Self-Management Educational Program|
16336977|NCT00372450|Procedure|management of therapy complications|
16336978|NCT00372450|Procedure|quality-of-life assessment|
16336979|NCT00372437|Drug|MGCD0103|MGCD0103 as an oral dose three times per week.
16336980|NCT00372437|Drug|Gemcitabine|Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.
16336981|NCT00372424|Drug|Herceptin|Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
16336982|NCT00372424|Drug|Sunitinib|SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
16336983|NCT00372424|Drug|Taxotere|The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
16336984|NCT00372411|Device|Robot-Assisted Therapy - MIT-MANUS System|The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.
16336985|NCT00372411|Other|Intensive Comparison Therapy|The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).
16336986|NCT00372411|Other|Usual Care|The usual chronic stroke care as delivered at each participating medical center
16336987|NCT00372385|Drug|Ribavirin|tablet
16336988|NCT00372385|Drug|Pegylated Interferon Alfa 2a|Solution for injection
16336989|NCT00372385|Drug|Placebo|tablet
16336990|NCT00372385|Drug|Telaprevir|tablet
16336991|NCT00372372|Drug|risedronate|
16336992|NCT00372346|Procedure|Transplantation of autologous endothelial progenitor cells|
16336993|NCT00372333|Drug|IDEA-033|
16336994|NCT00372320|Genetic|Gene Transfer|
16336995|NCT00372320|Drug|AdhAQP1|
16336996|NCT00372307|Drug|Application of pimecrolimus|
16336997|NCT00372294|Drug|pyrimethamine-sulfadiazine + prednisolone|Administration of pyrimethamine-sulfadiazine + prednisolone
16336998|NCT00372294|Drug|Clindamycin+Dexamethasone|Intravitreal injection of Clindamycin+Dexamethasone
16336999|NCT00372281|Drug|Cliavist|Injection of 0,9 mL (weight < 60kg) or 1,4 mL (weight > 60kg) of Cliavist (ferucarbotran) by direct intraveinous way, 48 h following the MRI done with gadolinium.
16337000|NCT00372268|Device|Aeroneb® Pro (Nektar® Company)|The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
16337001|NCT00372268|Device|Aeroneb® Pro (Nektar® Company)|The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
16337002|NCT00372255|Biological|Influsplit SSW® 2005/2006|Study influenza vaccine was administered intramuscularly in the non-dominant arm
16337003|NCT00372242|Behavioral|Prospective Longitudinal Interventional Stury|
16337004|NCT00372229|Drug|Valganciclovir CMV Prophylaxis|900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
16337005|NCT00372229|Drug|Valganciclovir (Pre-emptive CMV Therapy)|If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
16337006|NCT00372229|Drug|Ganciclovir|If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
16337007|NCT00372216|Drug|Clopidogrel (Iscover/Plavix)|Pre-hospital loading-dose of 600 mg Clopidogrel as early as possible
16337177|NCT00370734|Drug|Botulinum toxin A injection|
16337008|NCT00372203|Procedure|Endobronchial Ultrasound Guided Transthoracic Needle Biopsy|Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy.
16337009|NCT00372190|Device|Tensionfree vaginal mesh kit (Prolift)|Insertion of a tension free vaginal mesh using a Prolift mesh kit
16337010|NCT00372190|Procedure|classic vaginal prolapse surgery (fascia plication)|classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
16337011|NCT00372177|Radiation|Fab-fragment of Anti-human CD4|Sterile lyophilized Powder for Preparation of a Solution and sterile labelling Buffer labelling with Tc99m-Pertechnetat Intravenous injection
16337012|NCT00372164|Procedure|American Society of Interventional Pain Physician Guidelines|
16337013|NCT00372151|Dietary Supplement|L-Theanine|400 mg/day, caps.
16337014|NCT00372151|Other|Placebo|caps.
16337015|NCT00372138|Procedure|PRP + autologous thrombin|simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
16337016|NCT00372125|Drug|Norditropin SimpleXx|0.3-0.4 mg/day placebo or GH for 4 weeks. Thereafter 0.6-0.8 mg/day placebo or GH for 11 months. During the following 24 months open phase doses will be individually titrated.
16337017|NCT00372112|Drug|GW642444|GW642444H
16337018|NCT00372112|Other|Placebo|Placebo administered twice daily
16337019|NCT00372099|Drug|Salmon calcitonin|nasal salmon calcitonin 200UI/day during 2 years
16337020|NCT00372086|Drug|Rosiglitazone|
16337021|NCT00372073|Drug|seliciclib|1200 mg bid x 3 days every 2 weeks
16337022|NCT00372073|Drug|placebo|1200 mg bid x 3 days every 2 weeks
16337023|NCT00372060|Drug|sitagliptin phosphate|Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
16337024|NCT00372060|Drug|Comparator: sitagliptin phosphate (MK0431)|Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
16337025|NCT00372060|Drug|Comparator: pioglitazone|pioglitazone once daily for 52 weeks
16337026|NCT00372060|Drug|Comparator: placebo (unspecified)|Placebo once daily for 12 weeks
16337027|NCT00372047|Device|multiphoton laser imaging|
16337028|NCT00372034|Device|Temporary Collagen Inserts|
16337029|NCT00372021|Procedure|optic nerve neurotomy|
16337030|NCT00372008|Drug|Testosterone|
16337031|NCT00371995|Drug|Liposomal amphotericin B and Miltefosine|"Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
~Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)"
16337032|NCT00371982|Drug|Fish oil (Maxepa)|
16337033|NCT00371969|Behavioral|Enhanced Motivational Interview|The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).
16337034|NCT00371969|Behavioral|Standard Motivational Interview or viewing DVD|Brief motivational interview, viewing a DVD on HIV self-care.
16337035|NCT00371956|Drug|raloxifene|60mg/day
16337036|NCT00371956|Drug|placebo|tab 1 daily
16337037|NCT00371943|Procedure|band ligation|
16337038|NCT00371930|Procedure|application of a dye suspension followed by a laser intervention|
16337039|NCT00371904|Drug|Rituximab|Single dose (375 mg/m2) of rituximab to be given intravenously (IV) 14 days prior to transplantation
16337040|NCT00371904|Drug|Standard Care|Standard care
16337041|NCT00371891|Procedure|Multidetector Computed Tomography Coronary Angiography|1 Multidetector Computed Tomography Coronary Angiography
16337042|NCT00371878|Biological|7-valent pneumococcal conjugate vaccine (Prevnar)|
16337043|NCT00371865|Behavioral|Cognitive-behavioral therapy|8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
16337044|NCT00371865|Behavioral|Acceptance-based therapy|8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
16337045|NCT00371852|Drug|lactoserum|
16337046|NCT00371839|Procedure|Audiological Evaluation|Tests of hearing, cognition, and speech perception
16337047|NCT00371826|Drug|Everolimus (RAD001)|
16337048|NCT00371826|Drug|Cyclosporine (Calcineurin Inhibitor (CNI))|
16337049|NCT00371826|Drug|Methylprednisone/prednisone|
16337050|NCT00371826|Drug|Mycophenolate sodium (MPA)|
16337051|NCT00371813|Drug|Varenicline tartrate|
16337052|NCT00371813|Drug|Placebo|
16337053|NCT00371800|Drug|cinnamon|
16337054|NCT00371787|Device|Soft contact lens|Soft contact lens
16337055|NCT00371761|Biological|Pegylated interferon alfa-2b (PegIntron)|Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
16337056|NCT00371761|Drug|Adefovir dipivoxil (adefovir)|10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks
16337057|NCT00371748|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary Stent, 2.25 mm
16337058|NCT00371748|Device|TAXUS™ Express2|Paclitaxel-Eluting Coronary Stent System
16337059|NCT00371748|Device|Express2|Coronary Stent System
16337060|NCT00371735|Drug|chlorproguanil-dapsone-artesunate|
16337061|NCT00371735|Drug|chlorproguanil-dapsone|
16337062|NCT00371722|Procedure|Appendectomy|
16337063|NCT00371709|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary Stent System
16337064|NCT00371709|Device|TAXUS™ Express|Paclitaxel-Eluting Coronary Stent System
16337065|NCT00371696|Drug|diclofenac|
16337066|NCT00371696|Drug|paracetamol|
16337067|NCT00371696|Device|heat retaining knee support|
16337068|NCT00371696|Device|standard knee support|
16337069|NCT00371683|Drug|Enoxaparin + Placebo|Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
16337070|NCT00371683|Drug|Apixaban + Placebo|Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
16337071|NCT00371670|Drug|balicatib (AAE581)|
16337114|NCT00371280|Procedure|orbital implant|Implantation of pegged versus unpegged hydroxyapatite orbital implants
16337115|NCT00371267|Behavioral|Telephone-delivered Cognitive Behavior Therapy|Telephone-delivered cognitive behavior therapy for pain management
16337178|NCT00370721|Drug|bevacizumab|
16337072|NCT00371644|Behavioral|Cognitive Processing Therapy|CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
16337073|NCT00371644|Behavioral|Present-Centered Therapy|PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
16337074|NCT00371631|Biological|Insertion of urinary catheters coated with E. coli 83972|All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
16337075|NCT00371618|Procedure|Fluoroscopy|
16337076|NCT00371592|Drug|Acyclovir|800 mg tablet taken orally twice daily
16337077|NCT00371592|Drug|Acyclovir placebo|800 mg placebo tablet taken orally twice daily
16337078|NCT00371579|Drug|rosuvastatin|
16337079|NCT00371566|Drug|Lapatinib oral tablets|
16337080|NCT00371566|Drug|Placebo|
16337081|NCT00371553|Drug|SU011248 (Sunitinib)|
16337082|NCT00371540|Other|Home visit by community care coordinators|Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.
16337083|NCT00371527|Drug|ipratropium|
16337084|NCT00371501|Drug|Rosuvastatin|10mg/day
16337085|NCT00371501|Drug|placebo|one tablet/day
16337086|NCT00371501|Drug|aspirin|80mg/day
16337087|NCT00371501|Drug|placebo|placebo
16337088|NCT00371488|Drug|GW572016 oral tablets|Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.
16337089|NCT00371475|Device|TAXUS Liberté-SR|Paclitaxel-Eluting Coronary 38 mm Stent
16337090|NCT00371475|Device|TAXUS™ Express|Paclitaxel-Eluting Coronary Stent System
16337091|NCT00371462|Behavioral|Use of PDA + support to reduce weight and pain|participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months.
16337092|NCT00371462|Behavioral|MOVE! level 2 group weight loss counseling|Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months.
16337093|NCT00371436|Procedure|Progressive Audiologic Tinnitus Management|The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
16337094|NCT00371436|Procedure|Usual Care|Typical audiologic care that would be received in a VA Audiology Clinic.
16337095|NCT00371423|Device|TAXUS Liberté™-SR|Paclitaxel-Eluting Coronary Stent System
16337096|NCT00371423|Device|TAXUS Liberté™-SR|Paclitaxel-Eluting Coronary Stent System
16337097|NCT00371410|Procedure|vitrectomy|
16337098|NCT00371410|Drug|intravitreal triamcinolone acetonide|
16337099|NCT00371410|Procedure|macular focal laser photocoagulation|
16337100|NCT00371397|Behavioral|Hatha Yoga Classes|Iyengar yoga, the form of hatha yoga used in this study, emphasizes the use of props to help students achieve precise postures safely and comfortably according to their particular body types and needs. The yoga activity sessions were directed by four experienced yoga teachers following a script. The poses used were (in order) Supta Baddha Konasana (Reclining Bound Angle Pose), Adho Mukha Svanasana (Downward Facing Dog), Supported Uttanasana (Intense Forward Stretch), Parsvotanasana (Intense Side Stretch Pose), Prasarita Padottanansana (Wide-Legged Forward Bend), Janu Sirsasana (Head to Knee Pose), Bharadvajasana (Simple Seated Twist Pose), Viparita Karani (Restful Inversion), Supported Setu Bandha Sarvanagasana (Bridge Pose), and Savasana (Corpse Pose). Blood draws occurred during the last two minutes of Supta Baddha Konasana (pose held 10 minutes), Viparita Karani (10 minutes), and Savasana (15 minutes).
16337101|NCT00371397|Behavioral|Movement Control|Walking on a treadmill at .5 miles per hour was used to control for general physical movement/cardiovascular expenditure because it best approximated the heart rates during the restorative yoga session. To match the lower heart rate, women also rested supine on a bed for several minutes after walking, before and after getting their blood drawn.
16337102|NCT00371384|Procedure|massage|UP to 10 massages over 10 weeks
16337103|NCT00371371|Procedure|Bone marrow punction|A total volume of 100 ml bone marrow will be aspirated from the iliac crest under local anaesthesia (lidocaine) according to local routine. To maximise the patients comfort, 5-10 mg midazolam and 50 ug fentanyl will be administered intravenously.
16337104|NCT00371371|Procedure|BM-MNC infusion|Repeated intra-arterial infusion of autologous BM-MNC into the common femoral artery
16337105|NCT00371371|Procedure|Placebo infusion|Repeated intra-arterial infusion of placebo (PBS/4% HAS/heparin, coloured with autologous erythrocytes to match the colour of BM-MNC suspension) into the common femoral artery.
16337106|NCT00371345|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months)
16337107|NCT00371345|Drug|Dasatinib 100 mg|Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
16337108|NCT00371332|Drug|Minocycline HCL Microspheres|
16337109|NCT00371319|Drug|tacrolimus|0.06-0.1 mg/kg/day
16337110|NCT00371319|Drug|mycophenolate mofetil|2-3 gm/day
16337111|NCT00371306|Drug|Insulin versus glucovance (glyburide/metformin)|
16337112|NCT00371293|Behavioral|Weight Loss Program|Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
16337113|NCT00371293|Device|CPAP therapy|Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
16337176|NCT00370747|Drug|Placebo|
16337116|NCT00371267|Other|Telephone-delivered Patient Education|Telephone-delivered patient education regarding chronic pain
16337117|NCT00371254|Drug|Dasatinib|Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg <6 months)
16337118|NCT00371254|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg <6 months)
16337119|NCT00371228|Procedure|Delay of umbilical cord clamping|Umbilical cord delayed until pulsation stops.
16337120|NCT00371215|Biological|rThrombin|1000 U/mL applied topically
16337121|NCT00371202|Procedure|keratoplasty|
16337122|NCT00371189|Drug|Placebo|Normal saline.
16337123|NCT00371189|Biological|Ad35.CS.01 Circumsporozoite Malaria Vaccine|Adenovirus Type 35 Circumsporozoite Malaria Vaccine (Ad35.CS.01); administered at 0, 1, and 6 months; dosage levels: 10^8 viral particles (vp)/mL, 10^9 vp/mL, 10^10 vp/mL and 10^11 vp/mL.
16337124|NCT00371176|Behavioral|Exposure therapy|A manualized form of treatment that involves vividly visualizing indexed trauma with the guidance of a therapist
16337125|NCT00371176|Drug|D-Cycloserine|A partial NMDA agonist that has been shown in human trials to facilitate and strengthen extinction with CBT.
16337126|NCT00371176|Other|Placebo pill|
16337127|NCT00371150|Drug|Entecavir|Tablets, Oral, 0.5 mg, once daily, up to 52 weeks
16337128|NCT00371137|Drug|Xyrem®|two doses
16337129|NCT00371137|Drug|Placebo|Oral Solution
16337130|NCT00371124|Drug|Atropine Eye drops|
16337131|NCT00371111|Drug|Intravitreal injection of Triamcinolone|4 mg of Triamcinolone
16337132|NCT00371111|Drug|Intravitreal injection of Avastin|Injection of 1.25 mg of Avastin and
16337133|NCT00371098|Biological|Influenza vaccination: Influvac (SolvayPharma)|
16337134|NCT00371098|Biological|placebo influenza vaccine|
16337135|NCT00371085|Behavioral|education|Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction
16337136|NCT00371072|Procedure|trabeculectomy with mitomycin-C|
16337137|NCT00371059|Drug|Memantine|Memantine 10mg BD
16337138|NCT00371059|Drug|Placebo|Placebo 10 mgs BD
16337139|NCT00371046|Procedure|Transvaginal ultrasound cervical length|
16337140|NCT00371046|Procedure|Cervicovaginal fetal fibronectin|
16337141|NCT00371033|Drug|Pregabalin|dosage
16337142|NCT00371033|Drug|Placebo|dosage
16337143|NCT00371020|Drug|low molecular weight heparin, 5-FU|
16337144|NCT00371007|Drug|MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks|
16337145|NCT00371007|Drug|Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks|
16337146|NCT00370994|Procedure|Caudal epidural injection|Caudal epidural injection with catheterization
16337147|NCT00370994|Procedure|Percutaneous adhesiolysis|Percutaneous adhesiolysis with hypertonic saline neurolysis
16337148|NCT00370981|Drug|pagoclone|
16337149|NCT00370968|Drug|Zinc sulphate|
16337150|NCT00370955|Procedure|phacoemulsification using either high vacuum or low vacuum techniques|All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.
16337151|NCT00370942|Drug|GW823093C A|A=45 mg
16337152|NCT00370942|Drug|GW823093C B|B=30 mg
16337153|NCT00370942|Drug|GW823093C C|C=25 mg
16337154|NCT00370929|Behavioral|Meditation|
16337155|NCT00370916|Behavioral|Physician-initiated medication reconciliation|Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template
16337156|NCT00370916|Behavioral|Pharmacist-initiated medication reconciliation|Pharmacist performed and documented medication reconciliation
16337157|NCT00370890|Drug|Adjuvant chemotherapy (gemcitabine and cisplatin)|Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles
16337158|NCT00370877|Drug|rFVIIa|The patients included in this arm of the study will recieve standard care for post-partum hemorrhage plus a slow intravenous injection (2ml/min) of rFVIIa (60µg/kg)
16337159|NCT00370877|Procedure|Standard Care|Patients will recieve standard care for post partum hemorrhage according to current recommendations.
16337160|NCT00370864|Biological|H5N1 pandemic influenza vaccine|
16337161|NCT00370851|Drug|Avastin (Bevacizumab)|Intravitreal injection of 125 mg Avastin
16337162|NCT00370838|Drug|Levetiracetam|The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
16337163|NCT00370838|Drug|Clonidine|The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
16337164|NCT00370825|Drug|Combination therapy with AmBisome and miltefosine|
16337165|NCT00370812|Procedure|amniotic membrane transplantation|AMT with conventional medical therapy (group A) or medical treatment only (group B). AMT will be performed within 24h of presentation. Amniotic membrane will remain in place for 7-14 days.
16337166|NCT00370799|Drug|Caudal epidural injection|group 1: Caudal epidural injection local anesthetics only
16337167|NCT00370799|Drug|Caudal Epidural Injection with generic Celestone|Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
16337168|NCT00370799|Drug|Caudal Epidural Injection with Celestone|Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
16337169|NCT00370799|Drug|Caudal Epidural Injection with DepoMedrol|Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
16337170|NCT00370786|Drug|bevacizumab|
16337171|NCT00370773|Device|Precision Spinal Cord Stimulation System|
16337172|NCT00370760|Drug|oral colchicine, dexamethasone, low molecular weight heparin, 5-FU|
16337173|NCT00370760|Drug|placebo|
16337174|NCT00370747|Drug|Ecabet|ophthalmic solution 2.83%
16337175|NCT00370747|Drug|Ecabet|ophthalmic solution 3.70%
16337179|NCT00370708|Procedure|Oral Intake following admittance to the postpartum ward|
16337180|NCT00370695|Device|Precision Spinal Cord Stimulation System|Stimulation turned on from implant throughout the Study
16337181|NCT00370682|Biological|T-DEN F17|A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
16337182|NCT00370682|Biological|T-DEN F-19|A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
16337183|NCT00370682|Other|Placebo Comparator|A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
16337184|NCT00370669|Drug|bevacizumab|
16337185|NCT00370669|Drug|triamcinolone acetonide|
16337186|NCT00370656|Drug|Pregabalin|capsule, 150mg bd, 300mg bd
16337187|NCT00370656|Drug|Duloxetine|Capsule, 60mg on, 60mg bd
16337188|NCT00370656|Drug|Amitriptyline|Capsule. 25 mg bd, 25 mg om and 50 mg on
16337189|NCT00370643|Drug|human regular insulin|
16337190|NCT00370630|Drug|Avastin (Bevacizumab) and triamcinolone|
16337191|NCT00370617|Drug|metformin|
16337192|NCT00370604|Device|19g Tuohy-type epidural needle, 23g catheter|Patients in the experimental group will receive a 23g 90cm adult length epidural catheter placed via a 19g Tuohy epidural needle (SIMS Portex, Hythe, UK). The 19g Tuohy needle is a standard 3½ inch length.
16337193|NCT00370604|Device|=> 18g Tuohy-type needle|Patients in the control arm will receive a traditional large gauge (16g, 17g or 18g Tuohy or Hustead) epidural needle and a traditional epidural catheter. Two control needles and two control catheters will be designated apriori by each institution for use in the study.
16337194|NCT00370591|Drug|Salmeterol/fluticasone propionate and fluticasone propionate|
16337195|NCT00370578|Device|repeated thrombus aspiration during primary PCI|
16337196|NCT00370565|Drug|Inhaled Human Insulin|
16337197|NCT00370552|Drug|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
16337198|NCT00370552|Drug|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
16337199|NCT00370552|Drug|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
16337200|NCT00370539|Drug|verteporfin, bevacizumab, triamcinolone acetonide|
16337201|NCT00370526|Procedure|Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement|
16337202|NCT00370513|Drug|pazopanib|Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.
16337203|NCT00370500|Drug|Quetiapine fumarate|Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.
16337204|NCT00370474|Device|Bi-ventricular lead placement|
16337205|NCT00370448|Behavioral|school-based social support system|Training gatekeeper recruited from students and tutors and counselors for group 1; training counsellors for group 2; No special intervention for group 3
16337206|NCT00370435|Drug|GW274150|
16337207|NCT00370422|Drug|Triamcinolone, Bevacizumab|
16337208|NCT00370409|Procedure|Cryotherapy|Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
16337209|NCT00370396|Biological|Synflorix|1 dose injected IM in the right thigh or deltoid.
16337210|NCT00370396|Biological|Prevenar|1 dose injected IM in the right thigh or deltoid.
16337211|NCT00370396|Biological|Infanrix hexa|1 dose injected IM in the right thigh or deltoid.
16337212|NCT00370383|Drug|Erlotinib|erlotinib 150 mg/day once daily
16337213|NCT00370383|Drug|Satraplatin|"satraplatin 100 mg/m2 orally once daily for 5 consecutive days (days 1-5)followed by erlotinib 150mg/day for 14 consecutive days (days 8-21).
~Satraplatin JM-216, bis-aceto-ammine dischlorocyclohexylamine platinum)is a third-generation platinum analogue with activity following oral administration. The molecular formula for satraplatin is C10H22N2Cl2O4Pt, which is structured as an octahedral platinum compound."
16337214|NCT00370370|Drug|bevacizumab|Injection of intravitreal bevacizumab
16337215|NCT00370370|Drug|bevacizumab + triamcinolone acetonide|Injection of bevacizumab + triamcinolone acetonide
16337216|NCT00370357|Drug|3% w/w SPL7013 Gel (VivaGel™)|
16337217|NCT00370344|Procedure|Laparoscopic cholecystectomy|Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
16337218|NCT00370344|Procedure|Small-incision open cholecystectomy|Operation by experts in small-incision open cholecystectomy.
16337219|NCT00370331|Drug|eltrombopag|Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.
16337220|NCT00370331|Drug|Placebo|Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down
16337221|NCT00370318|Biological|10 valent pneumococcal conjugate vaccine|
16337222|NCT00370318|Biological|Infanrix Hexa|
16337223|NCT00370318|Biological|Rotarix|
16337225|NCT00370305|Drug|rosiglitazone|89 mg BID for 8 weeks, orally
16337226|NCT00370292|Drug|Pemetrexed - Before Protocol Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
16337227|NCT00370292|Drug|Pemetrexed - After Protocol Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
16337228|NCT00370279|Procedure|scleral buckling, primary vitrectomy|Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
16337229|NCT00370266|Drug|Triamcinolone|
16337230|NCT00370253|Drug|Terlipressin|1mg/4 h per day
16337231|NCT00370253|Drug|Noradrenalin|0,1 mcg/kg/min
16337232|NCT00370240|Drug|Chlorhydrate de Ropivacaine|The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)
16337233|NCT00370240|Other|placebo|The PCB group received saline solution in equal volume.
16337234|NCT00370227|Biological|10 valent pneumococcal conjugate (vaccine)|
16337235|NCT00370201|Drug|colchicine|
16337236|NCT00370188|Drug|Topiramate|
16337237|NCT00370162|Drug|lactoserum|
16337238|NCT00370149|Device|Antibiotic-impregnated Catheters (M/R)|Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
16337239|NCT00370149|Device|Non-impregnated Catheters (C/S)|Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
16337240|NCT00370136|Drug|ultrasound contrast|
16337241|NCT00370110|Drug|Itopride 100 mg|100 mg three times daily
16337242|NCT00370110|Other|Placebo|
16337243|NCT00370110|Drug|Itopride 200 mg|200 mg three times daily
16337244|NCT00370097|Drug|FLOVENT (fluticasone propionate) HFA|FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
16337245|NCT00370097|Drug|Placebo HFA|Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
16337246|NCT00370084|Drug|Itopride|oral, three times daily
16337247|NCT00370084|Other|Placebo|oral, three times daily
16337248|NCT00370071|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
16337249|NCT00370058|Procedure|ECT treatment|
16337250|NCT00370045|Drug|Bivalirudin with and without eptifibatide|
16337251|NCT00370032|Drug|alosetron|
16337252|NCT00370019|Drug|Estradiol/Medroxyprogesterone acetate|
16337253|NCT00370006|Biological|Towne CMV vaccine|
16337254|NCT00369993|Drug|fluticasone propionate/salmeterol|
16337255|NCT00369967|Drug|NuvaRing|Initiation of NuvaRing for contraception
16337256|NCT00369954|Drug|carboplatin|
16337257|NCT00369954|Drug|gemcitabine hydrochloride|
16337258|NCT00369941|Drug|MK-0518|400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
16337259|NCT00369941|Drug|Comparator: efavirenz|600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
16337260|NCT00369941|Drug|Comparator: Truvada|One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
16337261|NCT00369941|Drug|Comparator: Placebo to MK-0518|Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
16337262|NCT00369941|Drug|Comparator: Placebo to efavirenz|Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
16337263|NCT00369928|Drug|PG-760564|100 mg BID, of oral PG-760564
16337264|NCT00369928|Drug|Placebo dose|placebo, BID, oral for 12 weeks
16337265|NCT00369928|Drug|PG-760564|25 mg BID, of oral PG-760564
16337266|NCT00369915|Drug|Scopolamine|
16337267|NCT00369915|Drug|Scopolamine|
16337268|NCT00369902|Procedure|acupuncture|
16337269|NCT00369889|Drug|bevacizumab|iv every 21 days
16337270|NCT00369889|Drug|Erlotinib|oral daily
16337271|NCT00369863|Drug|Triamcinolone acetonide|
16337272|NCT00369850|Other|laboratory biomarker analysis|Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
16337273|NCT00369850|Procedure|Dual energy X-ray absorptiometry (DEXA)|Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
16337274|NCT00369850|Procedure|Spine X-ray|Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
16337275|NCT00369837|Drug|clevidipine|Clevidipine was required to be administered continuously for a minimum of 18 hours and a maximum of 96 hours and was not to exceed a rate of 32.0 mg/h at any time. Use of an additional or alternative intravenous antihypertensive agent was allowed if the blood pressure target range was not achieved or maintained. If transition to an oral antihypertensive agent is required, then approximately 1 hour prior to the anticipated cessation of clevidipine infusion, but no less than at the 18-hour time point, an oral antihypertensive agent was allowed to be administered as clevidipine was down-titrated or terminated as needed in order to achieve the desired blood pressure level..
16337276|NCT00369824|Biological|Different formulations of GSK Biologicals' HPV vaccine (580299)|Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
16337277|NCT00369824|Biological|Menactra TM|One dose of vaccine administered intramuscularly
16337278|NCT00369824|Biological|Boostrix TM|One dose of vaccine administered intramuscularly
16337279|NCT00369811|Drug|Oxycodone, fentanyl|
16337280|NCT00369798|Procedure|PET scan|
16337281|NCT00369798|Drug|Rolipram|
16337284|NCT00369772|Drug|darbepoetin alfa|
16337285|NCT00369759|Other|Emergency Dept. Subjects with LRI or Apnea|No intervention; Epidemiological Study
16337286|NCT00369746|Drug|citalopram|tablets, 60 mg maximum, daily, 12 weeks
16337287|NCT00369733|Drug|Darbepoetin alfa|Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL
16337288|NCT00369720|Procedure|Titration of oxygen in delivery room|
16337289|NCT00369707|Drug|Rituximab|On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
16337290|NCT00369707|Drug|bortezomib|On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
16337291|NCT00369694|Drug|Terlipressin|2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
16337292|NCT00369694|Drug|Terlipressin & then Dummy|2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
16337293|NCT00369681|Drug|Bleomycin|
16337294|NCT00369681|Biological|Rituximab|
16337295|NCT00369681|Drug|Dacarbazine|
16337296|NCT00369681|Drug|Doxorubicin|
16337297|NCT00369681|Drug|Vinblastine|
16337298|NCT00369668|Behavioral|Bilateral movements and neuromuscular electrical stimulation|Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
16337299|NCT00369668|Behavioral|Bilateral movements and neuromuscular electrical stimulation|Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
16337300|NCT00369668|Behavioral|Bilateral movements and sham electrical stimulation|Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
16337301|NCT00369655|Biological|ziv-aflibercept|
16337302|NCT00369642|Behavioral|Cognitive-behavioral therapy|
16337303|NCT00369629|Drug|Gemcitabine|Patients will be treated in cohorts of 3-6 per cohort. The starting dose of gemcitabine will be 800 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 1200 mg/m^2.
16337304|NCT00369629|Drug|Pemetrexed|Patients will be treated in cohorts of 3-6 per cohort. The starting dose of pemetrexed will be 400 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 500 mg/m^2.
16337305|NCT00369616|Biological|CYT002-NicQb|
16337306|NCT00369603|Drug|Razadyne ER|4-weeks 8mg. Razadyne ER, then 4-weeks 16mg. Razadyne ER, and a subsequent 4-weeks of 24mg. Razadyne ER
16337307|NCT00369603|Drug|Aricept|8-weeks 5mg. Aricept and a subsequent 4-weeks of 10mg. Aricept
16337308|NCT00369590|Biological|ziv-aflibercept|Given IV
16337309|NCT00369590|Other|pharmacological study|correlative studies
16337310|NCT00369590|Other|laboratory biomarker analysis|correlative studies
16337311|NCT00369577|Drug|Inhaled Placebo|Inhaled Placebo, single dose
16337312|NCT00369577|Drug|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
16337313|NCT00369577|Drug|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
16337314|NCT00369564|Drug|glutamic acid|Given orally 3 times daily
16337315|NCT00369564|Other|placebo|Given orally 3 times daily
16337316|NCT00369551|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
16337317|NCT00369551|Drug|paclitaxel|Given IV
16337318|NCT00369551|Biological|bevacizumab|Given IV
16337319|NCT00369551|Drug|carboplatin|Given IV
16337320|NCT00369551|Other|laboratory biomarker analysis|Correlative studies
16337321|NCT00369538|Drug|losartan, hydrochlorothiazide|Two administrations of losartan per day,up to 100mg per day, during 2 months, followed by a wash-out during 1 month, and then one administration of hydrochlorothiazide, 25 mg per day during 2 months
16337322|NCT00369538|Drug|hydrochlorothiazide, losartan|One administration of hydrochlorothiazide, 25 mg per day during 2 months, followed by a wash-out during 1 month, and then, two administrations of losartan per day,up to 100mg per day, during 2 months
16337323|NCT00369512|Drug|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
16337324|NCT00369499|Device|PFO Closure|
16337325|NCT00369486|Procedure|Focal laser photocoagulation|Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study technique)
16337326|NCT00369486|Drug|40mg triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
16337327|NCT00369486|Drug|20mg triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
16337328|NCT00369486|Drug|40mg triamcinolone + laser|Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
16337329|NCT00369486|Drug|20mg triamcinolone + laser|Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
16337330|NCT00369473|Drug|AMG 108|125 mg via SC (subcutaneous) injection every 4 weeks
16337331|NCT00369473|Drug|AMG 108|250 mg via SC (subcutaneous) injection every 4 weeks
16337396|NCT00369018|Drug|methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)|MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
16337397|NCT00369005|Procedure|Red blood cell transfusion guidelines|
16337332|NCT00369460|Other|physiologic testing|Weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
16337333|NCT00369447|Procedure|External radiotherapy|Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable
16337334|NCT00369447|Biological|nimotuzumab|weekly dose until disease progression
16337335|NCT00369434|Drug|Desvenlafaxine succinate sustained-release (DVS SR)|
16337336|NCT00369408|Drug|Naltrexone|naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up
16337337|NCT00369408|Drug|placebo|placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up
16337338|NCT00369395|Drug|volociximab|Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.
16337339|NCT00369382|Drug|cyclosporine or tacrolimus|Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
16337340|NCT00369382|Drug|sirolimus|Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
16337341|NCT00369356|Drug|Prednisone|Bare metal stenting with administration of oral prednisone as described in the protocol
16337342|NCT00369356|Device|Drug eluting coronary stent|Stenting with DES (Cypher or Taxus)
16337343|NCT00369356|Device|Bare metal coronary stent|Stenting with BMS only
16337344|NCT00369343|Drug|Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)|DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
16337345|NCT00369343|Drug|Placebo|Placebo, daily (QD), tablet form, treatment period up to 8 weeks
16337346|NCT00369330|Device|external electrical cardioversion|
16337347|NCT00369317|Drug|asparaginase|Given IM
16337348|NCT00369317|Drug|daunorubicin hydrochloride|Given IV
16337349|NCT00369317|Drug|cytarabine|Given IV or IT
16337350|NCT00369317|Drug|thioguanine|Given orally
16337351|NCT00369317|Drug|etoposide|Given IV
16337352|NCT00369317|Other|laboratory biomarker analysis|Correlative studies
16337353|NCT00369304|Drug|pharmacokinetic (how the body absorbs and eliminates) interaction|
16337354|NCT00369291|Biological|keyhole limpet hemocyanin|KLH is a foreign protein to humans, it will be used to assess the immune response to a neo-antigen given as a single injection, 1 mg subcutaneously in the arm (per MT1999-06).
16337355|NCT00369291|Biological|tetanus toxoid|Tetanus toxoid booster 0.5 ml intramuscularly (IM) in the opposite arm (per MT1999-06)
16337356|NCT00369278|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Tablets for oral administration
16337357|NCT00369265|Drug|Lansoprazole|Lansoprazole 30mg twice daily
16337358|NCT00369265|Dietary Supplement|Sugar pill|placebo twice daily
16337359|NCT00369252|Drug|Nimotuzumab (TheraCIM h-R3)|
16337360|NCT00369239|Drug|risperidone long acting injectable|
16337361|NCT00369226|Drug|Bortezomib (Velcade)|Infusion for a total of 3 doses
16337362|NCT00369226|Drug|Tacrolimus|Taken until Doctor determines it is not necessary any more
16337363|NCT00369226|Drug|Methotrexate|Infusion for a total of 4 doses
16337364|NCT00369226|Procedure|blood stem cell transplantation|Allogeneic Non-myeloablative peripheral blood stem cell transplantation
16337365|NCT00369213|Device|Additional spermicidal lubricant to condoms|
16337366|NCT00369200|Drug|AFP464|Given IV
16337367|NCT00369200|Other|laboratory biomarker analysis|Correlative study
16337368|NCT00369200|Other|pharmacological study|Correlative study
16337369|NCT00369187|Drug|large protein molecule|
16337370|NCT00369174|Drug|rosiglitazone maleate|Given orally
16337371|NCT00369174|Other|laboratory biomarker analysis|Correlative studies
16337372|NCT00369161|Drug|Everolimus (RAD001)|
16337373|NCT00369161|Drug|Tacrolimus|
16337374|NCT00369161|Drug|Basiliximab|
16337375|NCT00369161|Drug|Corticosteroids|
16337376|NCT00369148|Drug|nateglinide(drug) mitiglinide(drug)|
16337377|NCT00369135|Procedure|combined intervention|
16337378|NCT00369122|Biological|Bevacizumab|Given IV
16337379|NCT00369122|Drug|Cisplatin|Given IV
16337380|NCT00369122|Radiation|External Beam Radiation Therapy|Undergo EBRT
16337381|NCT00369122|Radiation|Internal Radiation Therapy|Undergo brachytherapy
16337382|NCT00369109|Other|biologic sample preservation procedure|
16337383|NCT00369109|Other|immunohistochemistry staining method|
16337384|NCT00369109|Other|laboratory biomarker analysis|
16337385|NCT00369109|Procedure|biopsy|
16337386|NCT00369096|Drug|bemiparin 3500 IU/day|
16337387|NCT00369083|Procedure|Hospital at home treatment|
16337388|NCT00369070|Biological|Bevacizumab|15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks
16337389|NCT00369070|Drug|AMG 706|subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days
16337390|NCT00369070|Drug|Paclitaxel|All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
16337391|NCT00369070|Drug|Carboplatin|All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.
16337392|NCT00369044|Drug|prednisone|
16337393|NCT00369031|Biological|Human Immunodeficiency Virus glycoprotein 140 (vaccine)|Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
16337394|NCT00369031|Biological|HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant|Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
16337395|NCT00369031|Biological|Labile Toxin mutant LTK63 adjuvant|Labile Toxin mutant LTK63 adjuvant alone
16337398|NCT00368992|Biological|cetuximab|Given IV
16337399|NCT00368992|Drug|paclitaxel|Given IV
16337400|NCT00368992|Biological|bevacizumab|Given IV
16337401|NCT00368979|Drug|Dutasteride|once daily
16337402|NCT00368979|Drug|Placebo|once daily
16337403|NCT00368966|Biological|13-valent Pneumococcal Conjugate Vaccine|
16337404|NCT00368966|Biological|7-valent Pneumococcal Conjugate Vaccine|
16337405|NCT00368953|Device|Yukon Choice stent system|coronary stent implantation
16337406|NCT00368953|Device|Taxus Liberté stent system|coronary stent implantation
16337407|NCT00368940|Behavioral|PATH|PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning.
16337408|NCT00368940|Behavioral|ST-CI|Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character.
16337409|NCT00368927|Drug|sulindac|Given orally
16337410|NCT00368927|Other|placebo|Given orally
16337411|NCT00368914|Drug|sirolimus|
16337412|NCT00368914|Other|laboratory biomarker analysis|
16337413|NCT00368914|Other|pharmacological study|
16337414|NCT00368914|Procedure|biopsy|
16337415|NCT00368901|Drug|Darbepoetin alfa|Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL
16337416|NCT00368888|Device|Urine collection bag for infants|
16337417|NCT00368875|Drug|vorinostat|Given orally
16337418|NCT00368875|Drug|paclitaxel|Given IV
16337419|NCT00368875|Biological|bevacizumab|Given IV
16337420|NCT00368862|Drug|Ebixa (memantine hydrochloride)|
16337421|NCT00368862|Drug|Cipralex (escitalopram)|
16337422|NCT00368849|Drug|atomoxetine|This study utilizes a crossover design. Accordingly, half of the participants receive 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.
16337423|NCT00368849|Drug|Matching Placebo|This study utilizes a crossover design. Accordingly, half of the participants receive twice a day matching placebo at arm one while the remaining half receive this intervention at arm two.
16337424|NCT00368836|Device|BreathScreen PE|One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level
16337425|NCT00368823|Device|Electronic point-of-care delivery system|
16337426|NCT00368797|Drug|XRP0038 (NV1FGF)|
16337427|NCT00368771|Behavioral|IBS Stress Management|If randomly assigned to this intervention, the session with the therapist will consist of training about IBS symptoms and their relationship to stress, as well as skills training in relaxation and ways of identifying and challenging mistaken thoughts about life events. The goal of this treatment is to lessen mental and physical stressful reactions to daily events, and therefore lessen IBS symptoms as a reaction to stress. The patient will be encouraged to apply relaxation skills to stressful situations.
16337428|NCT00368771|Behavioral|IBS Symptom Management|If assigned to this group, the therapist will discuss feelings, over-attention to IBS symptoms, and your fear of IBS symptoms. Patients will learn how to identify thoughts that may increase your IBS symptoms and will practice how to change these thoughts to ones that make them feel more comfortable. The sessions will focus on reactions to daily life that in turn result in IBS Symptoms.
16337429|NCT00368771|Behavioral|IBS Educational Training|Those assigned to this group will be given educational materials about IBS and will discuss the reading material with the therapist. The reading topics include information on gut disorders, anatomy and physiology of the gut, assessment procedures, and how to manage IBS symptoms. Sessions will also consist of weekly reviews of daily records and IBS symptoms. The goal of this intervention is to provide educational training about IBS.
16337430|NCT00368758|Drug|Probiotic bacteria (Trevis R)|
16337431|NCT00368745|Drug|Pregabalin|GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.
16337432|NCT00368745|Drug|Placebo|GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
16337433|NCT00368719|Drug|Tacrolimus|Participants will be followed for 10 years to study the effects of Tacrolimus.
16337434|NCT00368706|Drug|solifenacin succinate|Oral
16337435|NCT00368706|Drug|tolterodine|oral
16337436|NCT00368693|Device|Dermal - Living Skin Replacement (Dermal-LSR)|The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator.
16337437|NCT00368680|Device|Early Bubble CPAP|
16337438|NCT00368654|Drug|Methotrexate|Initial dose 5 mg, then 15 mg per week
16337439|NCT00368654|Drug|Raptiva|Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
16337440|NCT00368641|Drug|Extraneal|Periotneal Dialysis
16337441|NCT00368628|Procedure|continuous positive airway pressure|Continuous Positive Airway Pressure initiated within 48 hours of stroke onset and continued for 90 days.
16337442|NCT00368602|Drug|Timoptic|Timoptic to be applied to the target wound daily for up to 12 weeks.
16337443|NCT00368602|Other|Placebo|Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.
16337444|NCT00368589|Drug|atorvastatin|
16337445|NCT00368576|Drug|SB 480848, tablets|
16337446|NCT00368563|Drug|Helioblock SX|
16337447|NCT00368550|Drug|Sertraline|Sertraline (to a maximum of 200 mg/day) for 14-week treatment period
16337448|NCT00368550|Drug|Placebo|Placebo for 14-week treatment period
16337449|NCT00368537|Drug|Tigecycline|Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
16337450|NCT00368537|Drug|ampicillin-sulbactam|"Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.
~A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued."
16337451|NCT00368524|Behavioral|contingency management and behavioral day treatment|
16337452|NCT00368511|Procedure|Music Listening|Listen to music and posture measurements
16337453|NCT00368498|Drug|teicoplanin|
16337454|NCT00368485|Device|Neurally Controlled Mechanical Ventilation|A new mode of mechanical ventilation controlled by the electrical activity of the diaphragm (NAVA) will be used before and after extubation.
16337455|NCT00368472|Drug|Perampanel|Perampanel 2 mg to 12 mg, once daily during the OLE study
16337456|NCT00368459|Drug|raloxifene|Raloxifene is a selective estrogen receptor modulator
16337457|NCT00368459|Drug|Placebo|Identical appearing placebo
16337458|NCT00368407|Device|308-nm excimer laser|
16337459|NCT00368394|Drug|Insulin glulisine|
16337460|NCT00368381|Drug|Hydrocortisone|Patients randomized to this arm will receive hydrocortisone for the treatment of adrenal insufficiency secondary to sepsis.
16337461|NCT00368368|Drug|GK Activator (2)|100mg po
16337462|NCT00368355|Drug|Ara-C|"day-8 through day-5
~3 g/m2 q 12 hours"
16337463|NCT00368355|Drug|Cyclophosphamide|"day-7 and day-6
~45 mg/kg"
16337464|NCT00368355|Biological|Campath-1H|"day-3 through day-1
~Dosing for children:
~5 - 15kg : 3mg IV in 30ml NS
~15.1 - 30kg : 5mg IV in 50ml NS
~>30 kg : 10mg IV in 100ml NS
~Adults will receive 10mg IV in 100ml NS"
16337465|NCT00368355|Radiation|Total Body Irradiation|"day-4 through day-1
~175 cGy x 2 at 24 cGy/min"
16337466|NCT00368355|Procedure|Stem Cell Infusion|Stem cells are infused on day 0
16337467|NCT00368342|Drug|Erythromycin, Azithromycin , Clarithromycin|
16337468|NCT00368329|Drug|Capecitabine (Xeloda)|PO bid daily on RT days: 500mg & 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)
16337469|NCT00368329|Drug|[18-F] Fluorodeoxyglucose (FDG)|5-10 mCi IV administration
16337470|NCT00368329|Drug|5-Fluorouracil (5-FU)|200mg/m2 continuous venous infusion
16337471|NCT00368329|Drug|Carboplatin|AUC 2, based onCalvert formula IV infusion
16337472|NCT00368316|Biological|Shigella conjugate vaccines|Shigella sonnei-rEPA and Shigella flexneri2a rEPA vaccines
16337473|NCT00368303|Drug|Paroxetine CR|
16337474|NCT00368303|Drug|Paroxetine IR|
16337475|NCT00368290|Drug|Modafinil|300mg a day for 8 weeks
16337476|NCT00368290|Drug|placebo|placebo pills for 8 weeks
16337477|NCT00368290|Behavioral|Cognitive Behavioral Therapy (CBT)|Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
16337478|NCT00368277|Drug|Aliskiren|Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning
16337479|NCT00368277|Drug|Ramipril|Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning
16337480|NCT00368277|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
16337481|NCT00368277|Drug|Amlodipine|Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
16337482|NCT00368264|Drug|infliximab|azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)
16337483|NCT00368264|Drug|placebo|azathioprine (2 mg/kg) plus four placebo infusions
16337484|NCT00368251|Other|Placebo|"Pharmaceutical Form: Tablet
~Concentration: 2.5 mg, 25 mg and 50 mg
~Route of Administration: Oral use"
16337485|NCT00368251|Drug|BRV 2.5 mg|"Pharmaceutical Form: Tablet
~Concentration: 2.5 mg
~Route of Administration: Oral use"
16337486|NCT00368251|Drug|BRV 25 mg|"Pharmaceutical Form: Tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
16337487|NCT00368251|Drug|BRV 50 mg|"Pharmaceutical Form: Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
16337488|NCT00368238|Drug|Recombinant human erythropoietin alfa (drug)|
16337489|NCT00368238|Drug|Aspirin (drug)|
16337490|NCT00368238|Drug|Clopidogrel (drug)|
16337491|NCT00368212|Behavioral|Relaxation response training|The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
16337492|NCT00368212|Behavioral|Psychoeducational counseling|Patients will receive five sessions of psychoeducational counseling from the nurse who works with the primary care physicians. Patients who are interested in continuing treatment or who have not responded to this first treatment step will then be referred for the second step, cognitive behavioral therapy (CBT), for more intensive treatment.
16337493|NCT00368186|Biological|Pneumo 23|
16337494|NCT00368173|Drug|rhIGF-I/rhIGFBP-3|
16337495|NCT00368160|Drug|Eszopiclone|eszopiclone 3 mg
16337496|NCT00368160|Drug|Placebo|Placebo tablet
16337497|NCT00368134|Drug|Vildagliptin|
16337556|NCT00367653|Drug|Azithromycin plus Chloroquine|Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
16337671|NCT00366639|Other|Acute Decompensated Heart Failure|Treatment & outcomes during hospital admission for Acute DHF
16337498|NCT00368121|Drug|Cetuximab +/- Dexamethasone|"Cetuximab dosing schedule:
~• Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly over 16 weeks. Mode of administration: intravenous infusion
~Dexamethasone dosing schedule:
~• 20 mg administered on day 1-3, q1w, starting week 5 if evidence of tumor progression or week 9 if no PR or CR to Cetuximab alone.
~Mode of administration: orally"
16337499|NCT00368108|Drug|2 mg perampanel|2 mg perampanel
16337500|NCT00368108|Drug|4 mg perampanel|4 mg perampanel
16337501|NCT00368108|Drug|placebo comparator|placebo comparator
16337502|NCT00368095|Behavioral|Intensive Education for Metabolic Syndrome Patients|Excercise, Intensive diatary program
16337503|NCT00368082|Biological|TGFbeta resistant LMP-specific CTLs|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Group One:
~Day 0 2 x 10^7 cells/m2 Day 14 2 x 10^7 cells/m2
~Group Two:
~Day 0 6 x 10^7 cells/m2 Day 14 6 x 10^7 cells/m2
~Group Three:
~Day 0 1.5 x 10^8 cells/m2 Day 14 1.5 x 10^8 cells/m2"
16337504|NCT00368069|Drug|Keppra® extended release formulation - XR|500mg extended release oral tablet, 2 tablets once daily
16337505|NCT00368069|Drug|Placebo|oral tablets, 2 tablets once daily
16337506|NCT00368056|Drug|Eszopiclone|eszopiclone 3 mg
16337507|NCT00368056|Drug|Placebo|Placebo tablet
16337508|NCT00368030|Drug|Eszopiclone|Eszopiclone 3 mg QD
16337509|NCT00368030|Other|Placebo|Placebo tablet
16337510|NCT00368017|Drug|pioglitazone|30 mg once a day for 12 weeks
16337511|NCT00368017|Drug|placebo|1 pill once a day for 12 weeks
16337512|NCT00367991|Drug|Recombinant human erythropoietin alfa (drug)|200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days
16337513|NCT00367991|Drug|Placebo|Normal saline to match active drug (rHuEpo)
16337514|NCT00367978|Drug|Amlodipine/benazepril|
16337515|NCT00367965|Drug|Eszopiclone|eszopiclone 3 mg
16337516|NCT00367965|Drug|placebo|placebo tablet
16337517|NCT00367952|Drug|apricitabine|800mg apricitabine twice daily orally for 96 weeks
16337518|NCT00367939|Drug|valsartan + amlodipine|
16337519|NCT00367926|Drug|American ginseng root / polysaccharides|
16337520|NCT00367913|Drug|Addition of clarithromycin to rifampicin and ethambutol|
16337521|NCT00367913|Drug|Addition of Ciprofloxacin to rifampicin and ethambutol|
16337522|NCT00367913|Biological|Vaccination with M.vaccae|
16337523|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
16337524|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
16337525|NCT00367887|Drug|HCV 796|Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
16337526|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
16337527|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
16337528|NCT00367887|Drug|HCV 796|Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
16337529|NCT00367887|Drug|Peg-Intron|SC injection, weight based dosing, weekly, 48 weeks
16337530|NCT00367887|Drug|REBETOL|Capsules, weight based dosing, Q12 hrs daily, 48weeks
16337531|NCT00367874|Drug|Buprenorphine|
16337532|NCT00367874|Drug|Valproate|
16337533|NCT00367861|Drug|interruption of Glivec®|interruption of Glivec®
16337534|NCT00367835|Drug|SPD503 (Guanfacine hydrochloride)|Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
16337535|NCT00367835|Drug|Placebo|Placebo
16337536|NCT00367822|Drug|Lisuride|
16337537|NCT00367822|Drug|Ropinirole|
16337538|NCT00367822|Drug|Placebo|
16337539|NCT00367809|Behavioral|Mindfulness-Based Stress Reduction (MSBR)|Mindfulness-Based Stress Reduction (MBSR) is the intervention of primary interest. It is a psycho-educational program of 8-weekly classes, 2.5 hours long taught by a trained instructor. Over the course of the program participants receive training in several formal meditation techniques: a body-scan meditation, sitting meditation, walking meditation and mindful Hatha yoga that involves simple stretches and movements. Participants are requested to practice meditation at home and to integrate informal mindfulness practices into their daily lives. The content of MBSR is described in the book Full Catastrophe Living by Jon Kabat-Zinn.
16337540|NCT00367809|Behavioral|Health Education (HE)|The active control condition was a peer-led chronic disease self-management program comprised of 8 weekly, 2.5 hour meetings. Led by trained peer-leaders, groups of participants discussed health challenges and problem-solved using a technique called action-planning. The curriculum described by Lorig and colleagues in the book Living a Health Life was the core of this program, and transplant-specific issues were covered in two meetings to match MBSR for time and attention.
16337541|NCT00367809|Behavioral|Delayed Intervention|A temporary wait-list control group; after 6 months, those in the Delayed Intervention were randomized a second time, to one of the active treatment arms (MBSR or HE).
16337542|NCT00367783|Drug|CP-741,952|
16337543|NCT00367770|Drug|Tracleer®|Patients will receive up to 125 mg b.i.d. of Tracleer.
16337544|NCT00367757|Procedure|Ablate AF triggers via PVI|Trigger-based ablation guided by pulmonary vein antrum isolation
16337545|NCT00367757|Procedure|Substrate via CFAEs|Substrate-based ablation using an approach targeting CFAEs
16337546|NCT00367757|Procedure|Combined approach for AF ablation|Combined trigger and substrate based approach
16337547|NCT00367744|Drug|Rosiglitazone|Rosiglitazone 4mg BID
16337548|NCT00367744|Drug|Placebo|Placebo for rosiglitazone
16337549|NCT00367731|Drug|Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)|
16337550|NCT00367718|Drug|Velcade|velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.
16337551|NCT00367705|Dietary Supplement|VSL#3®|1-2 sachets/day per os, 6 months
16337552|NCT00367705|Dietary Supplement|Placebo|1-2 sachets/day per os, 6 months
16337553|NCT00367692|Drug|PSI-697|
16337554|NCT00367679|Drug|Pazopanib|Pazopanib is an oral, potent, multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit. Subjects were to receive 800 mg oral pazopanib daily for a minimum of 2 weeks to a maximum of 6 weeks.
16337555|NCT00367666|Device|MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)|
16337557|NCT00367653|Drug|Mefloquine|Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
16337558|NCT00367640|Drug|100 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16337559|NCT00367640|Drug|300 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16337560|NCT00367640|Drug|500 IR grass pollen allergen extract tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16337561|NCT00367640|Drug|Placebo tablet|One sublingual tablet daily during 4 months before pollen season and during pollen season
16337562|NCT00367627|Drug|Albendazole|
16337563|NCT00367614|Drug|pantoprazole|
16337564|NCT00367601|Drug|Erlotinib|Erlotinib 150 mg qd days 1-21
16337565|NCT00367601|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV, day 1
16337566|NCT00367588|Behavioral|Low bacterial diet|
16337567|NCT00367575|Procedure|Internet personalized alcohol feedback (PAF)|
16337568|NCT00367562|Drug|ENALAPRIL VALSARTAN METHYLPREDNISONE|
16337569|NCT00367549|Dietary Supplement|Energy-containing soft drink|Commercial energy/sports drink
16337570|NCT00367536|Drug|bazedoxifene/conjugated estrogens combination tablet|
16337571|NCT00367497|Drug|Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin|
16337572|NCT00367484|Biological|Rebif® (clone 484-39)|s.c. administered Rebif®
16337573|NCT00367471|Drug|lapatinib|Lapatinib (GW572016) is a potent small molecule, reversible inhibitor of both EGFR and ErbB2 tyrosine kinases
16337574|NCT00367471|Drug|carboplatin|An alkylating agent used in the treatment of some cancers
16337575|NCT00367471|Drug|trastuzumab|A monoclonal antibody that interferes with the HER2/neu receptor
16337576|NCT00367471|Drug|paclitaxel|A mitotic inhibitor used in cancer treatment
16337577|NCT00367458|Drug|Atorvastatin|80 mg atorvastatin oral daily
16337578|NCT00367458|Drug|Placebo|patients will be administered placebo
16337579|NCT00367445|Drug|Inhaled Human Insulin (Exubera)|
16337580|NCT00367445|Drug|Insulin Glargine (Lantus)|
16337581|NCT00367432|Drug|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
16337582|NCT00367419|Drug|Erythromycin|
16337583|NCT00367406|Device|Gamma 3 nail versus ACE trochanteric nail|Comparing Gamma 3 nail versus ACE trochanteric nail
16337584|NCT00367393|Drug|Pimecrolimus cream 1%|Pimecrolimus cream 1% bid, as needed
16337585|NCT00367380|Other|413ABM|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM
16337586|NCT00367380|Other|414WRR|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR
16337587|NCT00367380|Other|418JAL|+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL
16337588|NCT00367367|Procedure|Hysteroscopy and Curettage|
16337589|NCT00367341|Drug|escitalopram|Participants will receive treatment with escitalopram for 12 weeks.
16337590|NCT00367341|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT will include 16 1 hour sessions provided over 12 weeks.
16337591|NCT00367328|Device|1320nm Nd: YAG nonablative laser|a 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition.
16337592|NCT00367315|Drug|Lumiracoxib|
16337593|NCT00367302|Drug|buprenorphine|maintenance
16337594|NCT00367302|Drug|methadone|maintenance
16337595|NCT00367276|Drug|Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)|Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.
16337596|NCT00367263|Drug|Alvesco (Ciclesonide) 160 ug/day|
16337597|NCT00367250|Drug|Cetuximab|weekly i.v.
16337598|NCT00367250|Drug|Trastuzumab|weekly i.v.
16337599|NCT00367237|Drug|Infliximab + methotrexate (IFX + MTX)|Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.
16337600|NCT00367237|Drug|Methotrexate (MTX)|Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.
16337601|NCT00367224|Procedure|6 to 9 ultraviolet B treatments|Treatments with ultraviolet B with gradually progressive doses
16337602|NCT00367224|Procedure|Skin biopsies|4 mm punch biopsies of the skin
16337603|NCT00367211|Drug|PN 200 tablets (500 mg naproxen and 20 mg omeprazole)|
16337604|NCT00367211|Drug|Naproxen 500 mg tablets (PN 200 minus omeprazole)|
16337605|NCT00367198|Dietary Supplement|Pro-Stat|two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
16337606|NCT00367185|Drug|Thalidomide|
16337607|NCT00367172|Behavioral|Directly Administered Antiretroviral Therapy|
16337608|NCT00367159|Procedure|endoscopic treatment of vesico-renal reflux|Autologous Adipocytes Graft (lipostructure)
16337609|NCT00367146|Drug|MMF|
16337610|NCT00367133|Procedure|Standard of Care Group|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
16337611|NCT00367133|Drug|1mg triamcinolone acetonide|Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
16348659|NCT00276757|Drug|prednisolone|
16337612|NCT00367133|Drug|4mg triamcinolone acetonide|4mg intravitreal triamcinolone acetonide injection at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
16337613|NCT00367120|Drug|Azithromycin Extended Release|
16337614|NCT00367120|Drug|Amoxicillin/Clavulanate|
16337615|NCT00367094|Drug|Benazepril plus hydrochlorothiazide|
16337616|NCT00367081|Drug|TMX-SMX (Bactrim(R))|
16337617|NCT00367081|Drug|Pyrimethamine plus Sulfadiazine plus leucoverin|
16337618|NCT00367068|Drug|baclofen, intrathecal|
16337619|NCT00367068|Device|infusion pump for intrathecal baclofen, Synchromed, Medtronic|
16337620|NCT00367055|Drug|rosiglitazone-metformin|
16337621|NCT00367055|Drug|Metformin|
16337622|NCT00367055|Drug|metformin+ gliclazide|
16337623|NCT00367042|Device|Scalpel for tissue scoring|During Mohs surgery we will compare the outcomes of scarring, to determine whether a mark (with a pen) or a score with a scalpel will receive the best scar.
16337624|NCT00367042|Device|Surgical marker for tissue marking|You will be asked to participate, examined, discuss participation have procedure and come in for follow up for photos and check up.
16337625|NCT00367029|Behavioral|Individualized Print-Based Motivational Program|"Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year.
~Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff."
16337626|NCT00367016|Drug|Omalizumab|Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.
16337627|NCT00367016|Drug|Placebo|Placebo, given by subcutaneous injection.
16337628|NCT00367003|Device|Deep Brain Stimulation|The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
16337629|NCT00366990|Behavioral|Low Sodium Diet|Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics with a focus on lowering sodium intake.
16337630|NCT00366990|Behavioral|Regular Sodium Intake|Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.
16337631|NCT00366977|Behavioral|Multi-session telephone counseling|
16337632|NCT00366977|Drug|NRT patches|
16337633|NCT00366964|Device|Laser Treatment|The laser treatment involves the use of an FDA approved laser device (510K Clearance certificate) for hair removal and treatment of leg veins for females having skin types III - VI. The pulses are of appropriate energy and pulse duration based on the skin type.
16337634|NCT00366964|Device|Wave Light laser device for skin treatment|To determine efficacy of FDA approved Laser treatment for hair removal and leg veins. The Mydon Wavelight is a Long Pulsed Nd Yag Laser, Class IV 1064 nm 55W
16337635|NCT00366951|Procedure|Foley catheter only|
16337636|NCT00366951|Procedure|Extraamniotic saline infusion|
16337637|NCT00366938|Drug|Lumiracoxib|
16337638|NCT00366925|Device|Adacolumn®|
16337639|NCT00366912|Device|non-invasive ventilation|
16337640|NCT00366899|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
16337641|NCT00366899|Biological|7 valent pneumococcal conjugate vaccine|Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
16337642|NCT00366873|Procedure|Calcium absorption|formula with or without prebiotics
16337643|NCT00366860|Behavioral|Soy bread|
16337644|NCT00366834|Drug|Casopitant (GW679769) oral tablets|
16337645|NCT00366834|Drug|Casopitant (GW679769) intravenous|
16337646|NCT00366834|Drug|Dexamethasone intravenous|
16337647|NCT00366834|Drug|Ondansetron oral tablets|
16337648|NCT00366834|Drug|placebo|casopitant placebo
16337649|NCT00366808|Procedure|LASIK surgery|
16337650|NCT00366795|Drug|Satavaptan|oral administration once daily
16337651|NCT00366795|Drug|placebo|oral administration once daily
16337652|NCT00366782|Biological|rB/HPIV3|Live attenuated rB/HPIV3 vaccine given at a dose of 10^6 TCID50
16337653|NCT00366782|Biological|rB/HPIV3|Live attenuated rB/HPIV3 vaccine given at a dose of 10^5 TCID50
16337654|NCT00366782|Biological|Placebo|Placebo for rB/HPIV3 vaccine
16337655|NCT00366769|Device|Wavefront-guided LASIK using CustomVue platform|
16337656|NCT00366743|Procedure|Conventional LASIK|
16337657|NCT00366743|Procedure|Wavefront-guided LASIK|
16337658|NCT00366730|Drug|Nitazoxanide|
16337659|NCT00366704|Drug|bifeprunox|.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
16337660|NCT00366704|Drug|risperidone|4mg, QD, 8 week treatment
16337661|NCT00366691|Drug|Acular LS|
16337662|NCT00366691|Drug|Lotemax|
16337663|NCT00366678|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
16337664|NCT00366678|Biological|7-valent pneumococcal conjugate vaccine|Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
16337665|NCT00366678|Drug|Pentavac|The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
16337666|NCT00366665|Device|Legacy 20000|
16337667|NCT00366665|Device|Infinit system|
16337668|NCT00366652|Drug|desvenlafaxine SR|
16337669|NCT00366652|Drug|desipramine|
16337670|NCT00366652|Drug|duloxetine|
16348815|NCT00275522|Drug|Sirolimus|
16337672|NCT00366626|Drug|Naltrexone|Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7)
16337673|NCT00366626|Drug|Placebo|Placebo for 7 days matched to Naltrexone
16337674|NCT00366613|Procedure|Cataract surgery with Perfect Capsule and Sodium Chloride|
16337675|NCT00366600|Drug|neratinib|HKI-272
16337676|NCT00366587|Device|Cataract surgery and IOL implantation|
16337677|NCT00366574|Device|Amadeus Microkeratome|
16337678|NCT00366574|Device|IntraLase|
16337679|NCT00366548|Biological|13 valent pneumococcal conjugate vaccine with Polysorbate 80|
16337680|NCT00366548|Biological|13 valent pneumococcal conjugate vaccine without Polysorbate 80|
16337681|NCT00366535|Drug|Placebo|4 tabs b.i.d.
16337682|NCT00366535|Drug|Neurotropin|4 tabs b.i.d.
16337683|NCT00366522|Drug|LXR-623|
16337684|NCT00366496|Device|Acrysof single piece (SA60AT)|
16337685|NCT00366496|Device|Acrysof IQ (SN60WF)|
16337686|NCT00366483|Drug|Lecozotan SR|
16337687|NCT00366470|Drug|A. 100,000 IU Cholecalciferol per dose of 3.3ml|100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months
16337688|NCT00366470|Other|B. Migliol Oil without Cholecalciferol|3.3 ml Migliol Oil, every two weeks for two months
16337689|NCT00366457|Drug|Bevacizumab|Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
16337690|NCT00366457|Drug|Erlotinib|Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
16337691|NCT00366457|Drug|Gemcitabine|Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
16337692|NCT00366444|Drug|diclofenac potassium (XP21L)|25 mg every 6 hours
16337693|NCT00366444|Drug|Placebo|Placebo every 6 hours
16337694|NCT00366431|Drug|MOA-728|
16337695|NCT00366418|Drug|Rituximab|
16337696|NCT00366392|Device|Optical Aids|
16337697|NCT00366379|Drug|GK Activator (2)|25-200mg po bid for 20 weeks
16337698|NCT00366366|Biological|Infanrix-Hexa|
16337699|NCT00366353|Other|Sedation during SBT|
16337700|NCT00366353|Other|No sedation|
16337701|NCT00366340|Biological|13-valent pneumococcal conjugate vaccine|Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
16337702|NCT00366340|Biological|7-valent pneumococcal conjugate vaccine|Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
16337703|NCT00366327|Drug|Bifeprunox|Flex dose (20 or 30 mg)tablet, QD for 1 year
16337704|NCT00366301|Drug|Insulin glargine injection|Once daily for 14 weeks
16337705|NCT00366301|Drug|metformin|Up to 4 pils per day (2g per day) maximum
16337706|NCT00366301|Drug|Placebo pill|Up to 4 pills per day
16337707|NCT00366288|Drug|PAZ-417|2.5 mg, 5, 10, 25, 50 mg - fasted in healthy young 10 mg - food effect in healthy young 5 and 25 mg -fasted healthy elderly.
16337708|NCT00366275|Procedure|Immunochemotherapy, in vivo purging and autrotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 10^9/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day subcutaneously) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
16337709|NCT00366262|Drug|PLA-695|
16337710|NCT00366262|Drug|Naproxen|
16337711|NCT00366262|Drug|Placebo|
16337712|NCT00366249|Drug|Tigecycline|150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
16337713|NCT00366249|Drug|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
16337714|NCT00366236|Drug|Nitazoxanide|
16337715|NCT00366210|Behavioral|Constraint-Induced Movement (CI) Therapy|
16337716|NCT00366210|Behavioral|Stretching, Relaxation, & Biofeedback|Passive stretching of both arms, EMG biofeedback for more-impaired arm
16337717|NCT00366171|Drug|Bifeprunox|
16337718|NCT00366158|Device|Device: St. Jude Medical Victory dual-chamber pacemaker|Pacemaker implant
16337719|NCT00366158|Device|Ventricular Intrinsic Preference|Programming of pacemaker
16337720|NCT00366145|Biological|Mesenchymal Stem Cells|2 Infusions of 2 million cells/kg per week for 4 weeks
16337721|NCT00366145|Biological|placebo|2 Infusions per week for 4 weeks
16337722|NCT00366145|Drug|Standard of Care for GVHD|Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy).
16337723|NCT00366132|Device|Extracorporeal Shockwaves|
16337724|NCT00366119|Drug|Ramipril|
16337725|NCT00366106|Drug|bortezomib|Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
16337726|NCT00366106|Drug|dexamethasone|Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
16337727|NCT00366106|Drug|doxorubicin HCl liposome|Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle).
16337728|NCT00366093|Drug|Eszopiclone|eszopiclone 3 mg
16337729|NCT00366093|Drug|Placebo|placebo tablet
16337730|NCT00366080|Drug|GSK189254|
16337731|NCT00366067|Drug|Phenytoin|
16337732|NCT00366041|Drug|Dermal substrate cellularised LG002 (10x10cm)|application depending on burn injury surface
16337733|NCT00366041|Device|Dermal substrate uncellularised LG002 (10x10 cm)|depending on burn injury surface
16337734|NCT00366028|Behavioral|Organization Model|The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
16337735|NCT00366028|Behavioral|Data Feedback Model|The research team will periodically interview the facilities and provide them with reported hand hygiene data.
16337736|NCT00366015|Procedure|Robotic-assisted Coronary Surgical Revascularization|Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console
16337737|NCT00366015|Procedure|PCI- Drug Eluting Stents|Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery
16337738|NCT00366002|Drug|Darifenacin|Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
16337739|NCT00365989|Device|ExAblate Enhanced Sonication|
16337740|NCT00365976|Drug|Eszopiclone|Eszopiclone 3 mg po nightly for duration of study blind phase.
16337741|NCT00365976|Drug|Placebo|Placebo nightly over duration of double blind study phase
16337742|NCT00365963|Device|Comprehensive Health Enhancement Support System|computer based support and education
16337743|NCT00365950|Drug|Duration of anticoagulation|
16337744|NCT00365950|Drug|Warfarin duration|
16337745|NCT00365937|Biological|Immunological peptides and immunological adjuvants|
16337746|NCT00365937|Biological|HLA-A2 peptides|Tyrosinase.A2: lyophilized powder, 326 mcg, 5 injections every 3 weeks MAGE-C2.A2: lyophilized powder, 320 mcg, 5 injections every 3 weeks NY-ESO-1b.A2: lyophilized powder, 290 mcg, 5 injections every 3 weeks MAGE-4.A2: lyophilized powder, 299 mcg, 5 injections every 3 weeks MAGE-3.A2: lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-1.A2: lyophilized powder, 298 mcg, 5 injections every 3 weeks NA17.A2 (GnTV): lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-10.A2: lyophilized powder, 309 mcg, 5 injections every 3 weeks
16337747|NCT00365937|Biological|Montanide ISA51|Oil emulsion (W/O: droplet test S57 IN 001), conductivity less than 10mcs.cm-1, viscosity: 1500 mPas (brookfield DVI - spindle 2- Speed 30). For human applications. Injected 5 times every 3 weeks.
16337748|NCT00365937|Biological|IMP321|"Official name of the LAG-3 molecule is CD223. Chemical structure: hLAG-3Ig is a soluble human recombinant LAG-3 protein comprising the extra-cellular Ig-like domains.
~The IMP321 drug product is composed of a soluble recombinant protein at a 1.18 mg/ml concentration, in PBS (Na2HPO4 2H2O 8.1mM, KH2PO4 1.47mM, NaCl 137mM, KCl 2.68mM, PH 7.2). Batch number: S017/LC1/041011.IMP321 will be provided in 250mcl aliquots in brosilicate siliconized vials."
16337749|NCT00365924|Drug|Forteo|Open label single arm study with Forteo as an intervention
16337750|NCT00365911|Procedure|Taking blood sample|A blood sample will be taken.
16337751|NCT00365898|Drug|Hydromorphone Hydrochloride Extended-Release|
16337752|NCT00365885|Other|Computer-based clinical decision support.|computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
16337753|NCT00365872|Biological|Dendritic Cell (DC) Injections|"DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation.
~One additional DC injection was given before surgery to assess DC migration
~Patients were assigned to one of three cohorts:
~Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery"
16337754|NCT00365872|Procedure|Radiation therapy|Radiation was delivered 5 days per week (Monday-Friday).
16337755|NCT00365872|Procedure|Complete Resection - Surgery for tumor removal|Tumors were surgically resected 3-6 weeks after the completion of EBRT.
16337756|NCT00365859|Drug|Aripiprazole|Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
16337757|NCT00365846|Drug|Campath-1H|
16337758|NCT00365820|Drug|Tegaserod|
16337759|NCT00365807|Behavioral|Positively Fit|12-week group intervention for children with obesity and their parents/caregivers
16337760|NCT00365807|Other|Brief Family Intervention (Primarily education)|3 hours of contact with registered dietician for education and nutritional counseling.
16337761|NCT00365794|Drug|Topical testosterone gel 10 g/day|Testosterone gel therapy for 20 weeks
16337762|NCT00365781|Drug|ISIS 113715|
16337763|NCT00365768|Drug|Glutamine|Administered orally twice daily for 21 days
16337764|NCT00365768|Other|Placebo|Administered orally twice daily for 21 days
16337765|NCT00365755|Drug|carboplatin|
16337766|NCT00365755|Drug|cisplatin|
16337767|NCT00365755|Drug|cyclophosphamide|
16337768|NCT00365755|Drug|etoposide|
16337769|NCT00365755|Drug|melphalan|
16337770|NCT00365755|Drug|vincristine sulfate|
16337771|NCT00365755|Procedure|autologous bone marrow transplantation|
16337772|NCT00365755|Procedure|conventional surgery|
16337773|NCT00365742|Drug|simvastatin|
16337774|NCT00365742|Drug|red yeast rice|
16337775|NCT00365742|Drug|pharmaceutical grade fish oil|
16337776|NCT00365742|Behavioral|therapeutic lifestyle changes|
16337777|NCT00365729|Behavioral|Smear and biopsy testing for HPV-types and viral load|Smear and biopsy testing for HPV-types and viral load
16337778|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
16337779|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
16337780|NCT00365716|Biological|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
16337781|NCT00365716|Biological|Placebo (mcg) (Aluminum Adjuvant)225|placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
16337782|NCT00365716|Biological|Placebo (mcg) (Aluminum Adjuvant) 450|placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
16337783|NCT00365703|Procedure|Feeding tube insertion|"Orogastric feeding tube
~Nasogastric feeding tube"
16337890|NCT00364871|Drug|naltrexone and bupropion SR|naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
16337891|NCT00364858|Drug|Cerezyme|Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).
16337784|NCT00365690|Behavioral|Telephone-administered coping improvement therapy|Telephone-administered coping improvement therapy is aimed to improve coping in older adults living with HIV/AIDS. Participants will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. Cognitive behavioral principles will be used to evaluate stressor severity, develop problem- and emotion-focused coping skills, determine the relationship between coping strategies and stressor controllability, and optimize coping through use of social support resources. Between weekly sessions, participants will also work to improve coping abilities on their own.
16337785|NCT00365690|Behavioral|Telephone-administered supportive-expressive therapy|Telephone-administered supportive-expressive therapy is aimed to improve relationships with friends, family members, and health care providers. Participants in will partake in 12 weekly conference calls lasting approximately 90 minutes each. Six to eight participants and two group facilitators will be connected via telephone each week. Separate conference call groups will be conducted for men who have sex with men, heterosexual men, and women. The first 60 minutes of each session will focus on discussing topics believed to be of interest to older adults with HIV and providing up-to-date information related to living with HIV/AIDS. The last 30 minutes of each session will be devoted to discussing topics raised by the group.
16337786|NCT00365690|Behavioral|Individual therapy|Participants will receive no active treatment, but will have access to community-based support services that are commonly available to people living with HIV/AIDS. Additionally, participants who experience pronounced periods of emotional crisis and request assistance will be provided with brief, individual, telephone-based therapy by study clinicians.
16337787|NCT00365677|Device|The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm|Used with LASIK treatment for the correction of myopia and myopic astigmatism.
16337788|NCT00365677|Device|The Bausch & Lomb Zyoptix Tissue Saving algorithm|Used with LASIK treatment for the correction of myopia and myopic astigmatism.
16337789|NCT00365651|Procedure|Youth Soccer|
16337790|NCT00365638|Drug|simvastatin|
16337791|NCT00365612|Drug|Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)|
16337792|NCT00365599|Drug|suberoylanilide hydroxamic acid (SAHA, Vorinostat)|Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
16337793|NCT00365599|Drug|tamoxifen citrate (Tamoxifen)|Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).
16337794|NCT00365586|Drug|Ketoprofen Topical Patch , 20%|
16337795|NCT00365560|Drug|tiotropium|
16337796|NCT00365560|Drug|placebo|
16337797|NCT00365547|Biological|bevacizumab|Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason.
16337798|NCT00365547|Drug|topotecan hydrochloride|Topotecan 4 mg/m^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason.
16337799|NCT00365534|Procedure|MEI|
16337800|NCT00365521|Procedure|Photodynamic Therapy|
16337801|NCT00365508|Drug|nicotine lozenge|nicotine lozenge
16337802|NCT00365508|Drug|nicotine patch|transdermal nicotine patch
16337803|NCT00365495|Procedure|Physical training (aerobic training)|
16337804|NCT00365469|Dietary Supplement|Probiotic|Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
16337805|NCT00365469|Other|Placebo|Commercially available cow's milk based infant formula without probiotic supplementation
16337806|NCT00365456|Drug|Parathyroid Hormone (PTH)|Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
16337807|NCT00365456|Drug|Risedronate|Orally once weekly as one 35 mg tablet.
16337808|NCT00365443|Biological|V502|
16337809|NCT00365430|Behavioral|safety program|Education, patient involvement, tailored implementation and a computerized registration system
16337810|NCT00365417|Drug|Bevacizumab|15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles
16337811|NCT00365417|Drug|Doxorubicin|60 mg/m^2 IV every 21 days x 4 cycles
16337812|NCT00365417|Drug|Cyclophosphamide|600 mg/m^2 IV every 21 days x 4 cycles
16337813|NCT00365417|Drug|Capecitabine|Following clinical response assessment, 650 mg/m^2 twice a day (orally), days 1-14 every 21 days x 4 cycles
16337814|NCT00365417|Drug|Docetaxel|Following clinical response assessment, 75 mg/m^2 IV every 21 days x 4 cycles
16337815|NCT00365404|Behavioral|Diet and exercise promotion|
16337816|NCT00365391|Biological|bevacizumab|Given IV, 10 mg/kg, days 1 and 15 in every cycle
16337817|NCT00365391|Drug|erlotinib hydrochloride|Given orally, 150 mg, every day during each cycle.
16337818|NCT00365378|Biological|Comparator: HPV 16 L1 Vaccine|A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
16337819|NCT00365378|Biological|Comparator: Placebo|A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
16337820|NCT00365365|Drug|Doxorubicin and cyclophosphamide (AC) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~doxorubicin 60 mg/m^2 IV push or infusion followed by cyclophosphamide 600 mg/m^2 IV push or infusion
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
16337821|NCT00365365|Drug|Docetaxel (T) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~docetaxel 100 mg/m^2 IV
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
~Note: The starting dose of docetaxel was reduced to 75 mg/m^2 if toxicity occurred that met the criteria for doxorubicin dose reduction"
16337888|NCT00364910|Behavioral|Educational session and treatment as usual|Participants assigned to the educational session attend one meeting with a researcher to discuss the results from their evaluation. They could also be referred to a mental health clinic of their choice to help relieve their symptoms.
16337889|NCT00364884|Drug|ketoaminoacid|
16348816|NCT00275509|Drug|Thymoglobulin|
16337822|NCT00365365|Drug|Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~doxorubicin 50 mg/m^2 IV push or infusion followed by cyclophosphamide 500 mg/m^2 IV push or infusion followed by docetaxel 75 mg/m^2
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
16337823|NCT00365365|Drug|Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab|"For every 3-week cycle
~bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
~docetaxel in 75 mg/m^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by
~trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2)
~Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
16337824|NCT00365365|Drug|Bevacizumab and trastuzumab maintenance therapy|"bevacizumab 15 mg/kg was infused IV followed by
~trastuzumab 6 mg/kg IV
~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
16337825|NCT00365365|Drug|Bevacizumab maintenance therapy|"- bevacizumab 15 mg/kg was infused IV
~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
16337826|NCT00365352|Drug|XP13512 600MG|XP13512 600MG ONCE DAILY
16337827|NCT00365352|Drug|XP13512 1200MG|XP13512 1200MG ONCE DAILY
16337828|NCT00365352|Drug|PLACEBO|PLACEBO ONCE DAILY
16337829|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir|Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
16337830|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
16337831|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
16337832|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
16337833|NCT00365339|Drug|Atazanavir+Ritonavir+Tenofovir+Famotidine|Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
16337834|NCT00365326|Procedure|catheter-based intracoronary injection|
16337835|NCT00365313|Drug|celecoxib, esomeprazole|
16337836|NCT00365300|Drug|pantoprazole|
16337837|NCT00365300|Drug|Placebo|
16337838|NCT00365287|Drug|anti-thymocyte globulin|
16337839|NCT00365287|Drug|cyclophosphamide|
16337840|NCT00365287|Drug|cyclosporine|
16337841|NCT00365287|Drug|fludarabine phosphate|
16337842|NCT00365287|Drug|mycophenolate mofetil|
16337843|NCT00365287|Procedure|radiation therapy|
16337844|NCT00365287|Procedure|umbilical cord blood transplantation|
16337845|NCT00365274|Drug|Cyclophosphamide|Given IV 750 mg/m^2 day 1
16337846|NCT00365274|Drug|Doxorubicin hydrochloride|Given 50 mg/m^2 IV day 1
16337847|NCT00365274|Drug|vincristine sulfate|Given 1.4 mg/m^2 IV
16337848|NCT00365274|Drug|prednisone|100 mg orally daily days 1 - 5
16337849|NCT00365274|Drug|SGN-30|12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
16337850|NCT00365261|Drug|Eszopiclone|eszopiclone 2 to 3 mg po at bedtime
16337851|NCT00365261|Drug|Placebo|placebo 2 to 3 mg po at bedtime
16337852|NCT00365248|Drug|Fibrinogen human (TachoSil)|Resection of the liver with or without segmental liver transplantation
16337853|NCT00365222|Drug|Temozolomide|temozolomide 75 mg/m2 /d
16337854|NCT00365209|Other|laboratory biomarker analysis|Correlative studies
16337855|NCT00365209|Other|pharmacological study|Correlative studies
16337856|NCT00365209|Drug|curcumin|Given orally
16337857|NCT00365196|Behavioral|CBT Hostility Reduction Program|
16337858|NCT00365183|Drug|Motexafin gadolinium and pemetrexed|1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
16337859|NCT00365170|Drug|human insulin|
16337860|NCT00365170|Drug|insulin aspart|
16337861|NCT00365157|Drug|Eribulin Mesylate|Given IV
16337862|NCT00365157|Other|Laboratory Biomarker Analysis|Correlative studies
16337863|NCT00365157|Other|Pharmacological Study|Correlative studies
16337864|NCT00365144|Biological|bevacizumab|
16337865|NCT00365144|Drug|erlotinib hydrochloride|
16337866|NCT00365144|Other|laboratory biomarker analysis|
16337867|NCT00365131|Drug|Cerezyme (imiglucerase for injection)|
16337868|NCT00365118|Device|Pulsed dye laser (Candela), Intense pulsed light (Palomar)|
16337869|NCT00365105|Dietary Supplement|Calcium|At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
16337870|NCT00365105|Dietary Supplement|Vitamin D|400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
16337871|NCT00365105|Drug|zoledronic acid|4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
16337872|NCT00365105|Drug|Sm-153|Single dose intravenously 1 mCi/kg body weight.
16337873|NCT00365105|Radiation|Sr-89|Single dose intravenously 4 mCi.
16337874|NCT00365092|Procedure|Insertion of tympanostomy tubes|
16337875|NCT00365053|Drug|belinostat|Given IV
16337876|NCT00365053|Other|laboratory biomarker analysis|Correlative studies
16337877|NCT00365040|Procedure|Prk with mitomycin vs Lasik|
16337878|NCT00365027|Procedure|Delayed embryo transfer|
16337879|NCT00365001|Drug|tocilizumab [RoActemra/Actemra]|10mg/kg iv on day 8
16337880|NCT00365001|Drug|Methotrexate|10-25mg po/week
16337881|NCT00365001|Drug|Simvastatin|40mg po on days 1, 15 and 43
16337882|NCT00364988|Drug|pioglitazone+losartan|Pioglitazone (30 mg/daily) losartan (100 mg daily)
16337883|NCT00364988|Drug|losartan|losartan (100 mg daily)
16337884|NCT00364975|Behavioral|gourmet cooking workshop|
16337885|NCT00364936|Procedure|Palliative care service|
16337886|NCT00364923|Drug|Pralatrexate Injection|Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
16337887|NCT00364910|Behavioral|Cognitive behavioral therapy (CBT)|Participants meet with a therapist for three to five sessions brief exposure-based CBT.
16337892|NCT00364845|Drug|Darbepoetin alfa|Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.
16337893|NCT00364845|Drug|Placebo|Prefilled syringe placebo, to match active arm
16337894|NCT00364832|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of sc administration
16337895|NCT00364819|Drug|rituximab|rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours
16337896|NCT00364806|Drug|Prochlorperazine|
16337897|NCT00364806|Drug|Metoclopramide|
16337898|NCT00364793|Drug|Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)|"Oral Solution, Capsules or Tablets, Oral, once daily
~Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg)
~Didanosine (ddI) 240 mg/m2 (max 400 mg)
~Emtricitabine (FTC) 6 mg/kg (max 200 mg)
~Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer);
~Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)"
16337899|NCT00364780|Drug|XL647|XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 & 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.
16337900|NCT00364767|Dietary Supplement|A|Alcohol consumption (32 g/day) for 4 weeks
16337901|NCT00364767|Dietary Supplement|B|Water
16337902|NCT00364754|Drug|Tesmilifene (YMB 1002)|
16337903|NCT00364741|Drug|Oxygen|During and 2 hours after surgery
16337904|NCT00364702|Drug|methylphenidate|
16337905|NCT00364689|Drug|Rifaximin|
16337906|NCT00364689|Drug|Lactulose|
16337907|NCT00364689|Other|Placebo|
16337908|NCT00364676|Drug|VLI|Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
16337909|NCT00364676|Drug|VLI|Patients are dosed on Day 1 of a 21-day cycle.
16337910|NCT00364650|Drug|Probiotic Supplement|2 capsules twice daily
16337911|NCT00364650|Other|Placebo|placebo
16337912|NCT00364637|Drug|Sevoflurane (Volatile Anesthetic)|
16337913|NCT00364637|Drug|Total intravenous anesthesia|
16337914|NCT00364611|Drug|Bevacizumab|"Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
~On Day 1 of the 1st cycle over 120 minutes
~On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose
~On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses
~On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses"
16337915|NCT00364611|Drug|Docetaxel|Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
16337916|NCT00364611|Drug|Trastuzumab|"A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1.
~For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion"
16337917|NCT00364598|Drug|Anginera, a human tissue replacement therapy|
16337918|NCT00364585|Device|GreenLight Model 120 Laser System|
16337919|NCT00364572|Drug|epidural injection of etanercept|2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg
16337920|NCT00364572|Drug|placebo (control procedure)|Two injections of epidural saline 2 weeks apart
16337921|NCT00364559|Drug|Rosuvastatin|20 mg 10 days daily
16337922|NCT00364546|Drug|CG 5503;tapentadol|
16337923|NCT00364533|Drug|Tapentadol IR (CG5503)|Fixed Dose 50, 75, & 100 mg BID for 3 days
16337924|NCT00364533|Drug|Placebo|Fixed Dose Matching placebo for 3 days
16337925|NCT00364533|Drug|Oxycodone HCL IR|Fixed Dose 10 mg BID for 3 days
16337926|NCT00364533|Drug|Tapentadol IR (CG5503)|Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
16337927|NCT00364520|Other|Shanghai workers|
16337928|NCT00364494|Procedure|Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)|Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not
16337929|NCT00364481|Drug|omeprazole|
16337930|NCT00364481|Behavioral|Tongue exercises|
16337931|NCT00364468|Drug|pegfilgrastim|
16337932|NCT00364455|Drug|Epoetin alfa|
16337933|NCT00364442|Drug|fluticasone propionate/salmeterol|investigational drug
16337934|NCT00364429|Drug|[123]I-CNS 1261|Study Drug
16337935|NCT00364429|Drug|Lorazepam|Study Drug
16337936|NCT00364429|Drug|Risperidone|Study Drug
16337937|NCT00364416|Other|Any treatment used to treat CHF|Clinical Outcomes of Chronic Decompensated Heart Failure patients
16337938|NCT00364403|Behavioral|Low glycemic load|Provision of foods and dietary counseling to promote a low glycemic load diet
16337939|NCT00364403|Behavioral|Low fat diet|Provision of foods and dietary counseling to promote a low fat diet
16337940|NCT00364390|Drug|Anginera, a human tissue replacement therapy|
16337941|NCT00364377|Drug|Sitagliptin|100 mg once daily
16337942|NCT00364377|Other|Placebo|once daily for duration of the study
16337943|NCT00364364|Drug|Radiolabeled humanized PAM4 IgG|
16337944|NCT00364351|Drug|Vandetanib|once daily oral tablet
16337945|NCT00364351|Drug|Erlotinib|oral dose
16337946|NCT00364338|Behavioral|gourment cooking workshop|
16337947|NCT00364325|Other|Acute Decompensated Heart Failure|Standard of Care
16337948|NCT00364312|Behavioral|diet and physical activity|
16337949|NCT00364299|Device|Automatic control of tracheal tube cuff pressure|
16337950|NCT00364286|Drug|Dasatinib (BMS-354825)|50mg Orally twice daily
16337951|NCT00364273|Drug|GSK159802|GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
16337952|NCT00364273|Drug|Placebo|Subjects will receive placebo administered using DISKUS inhaler.
16338238|NCT00361985|Drug|Esomeprazole|Esomeprazole 40mg once daily orally.
16337953|NCT00364273|Drug|Salmeterol|Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
16337954|NCT00364260|Drug|epoetin alfa|
16337955|NCT00364247|Drug|CG5503 IR;tapentadol|
16337956|NCT00364234|Device|Low magnitude mechanical stimuli|20 minutes standing on low magnitude high frequency vibrating platform
16337957|NCT00364221|Drug|Rosiglitazone|
16337958|NCT00364195|Drug|Tesmilifene (YMB1002)|
16337959|NCT00364182|Drug|Recombinant Coagulation Factor IX (BeneFIX)|100 IU/kg once weekly then crossover to 50 IU/kg twice weekly
16337960|NCT00364182|Drug|Recombinant Coagulation Factor IX (BeneFIX)|50 IU/kg twice weekly then crossover to 100 IU/kg once weekly
16337961|NCT00364169|Procedure|Degree of constipation|
16337962|NCT00364156|Drug|Standard Patch Treatment|8-weeks of nicotine patch + 16-weeks of placebo
16337963|NCT00364156|Drug|24-weeks of nicotine patch|24-weeks of 21mg nicotine patch
16337964|NCT00364143|Drug|IHL-305 (irinotecan liposome injection)|
16337965|NCT00364130|Device|Low magnitude mechanical stimulus|10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
16337966|NCT00364130|Device|Placebo (inactive) low magnitude mechanical stimulus|10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
16337967|NCT00364117|Behavioral|Timely Discharge (Remote Presence Technology)|
16337968|NCT00364104|Drug|Quadruple sequential Helicobacter pylori eradication + iron sulfate|A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation
16337969|NCT00364104|Drug|Quadruple sequential Helicobacter pylori eradication therapy|A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation
16337970|NCT00364104|Drug|Ferrous sulfate|6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy
16337971|NCT00364104|Drug|Placebo|Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).
16337972|NCT00364091|Drug|R89674 0.025% ophthalmic solution|
16337973|NCT00364065|Device|Ferris PainWrap|
16337974|NCT00364052|Drug|oral Valganciclovir vs oral Ganciclovir|
16337975|NCT00364039|Drug|AV650|
16337976|NCT00364026|Drug|darusentan|
16337977|NCT00364013|Drug|Panitumumab|Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
16337978|NCT00364013|Drug|FOLFOX regimen|The FOLFOX regimen consisted of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m^2 IV bolus followed by 600 mg/m^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.
16337979|NCT00364000|Drug|Calcium acetate|Calcium acetate in 240 chronic HD patients
16337980|NCT00364000|Drug|Sevelamer|label sevelamer (RenagelR) 800 mg tablets
16337981|NCT00363987|Drug|Ketosteril®|1 tablet Ketosteril/5kgBW/d
16337982|NCT00363987|Other|diabetic diet|Energy 30-35 Kcal/kg BW/d + protein 0.8 g/kg BW/d
16337983|NCT00363974|Drug|XIAP antisense|2 days loading dose followed by weekly 2hr infusion
16337984|NCT00363961|Behavioral|Resistance exercise|resistance exercise vs sham comparison
16337985|NCT00363948|Drug|Placebo|Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
16337986|NCT00363948|Drug|Sitagliptin phosphate|Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
16337987|NCT00363935|Drug|Dexmedetomidine|
16337988|NCT00363922|Behavioral|Rehabilitation in institution|Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
16337989|NCT00363922|Behavioral|Rehabilitation at home|Subjects get a written prescription of exercise training, diet, etc. to follow at home.
16337990|NCT00363922|Behavioral|Out-patient rehabilitation at the hospital|This intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD)
16337991|NCT00363909|Drug|citalopram hydrobromide|
16337992|NCT00363909|Other|placebo|
16337993|NCT00363896|Drug|Aclidinium bromide|Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
16337994|NCT00363896|Drug|Placebo|Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
16337995|NCT00363883|Drug|vorinostat|Given orally
16337996|NCT00363883|Other|laboratory biomarker analysis|Correlative studies
16337997|NCT00363870|Biological|Fluarix vaccine|
16337998|NCT00363857|Drug|Ropinirole|
16337999|NCT00363844|Drug|Sitagliptin phosphate|50 mg QD or 100 mg QD for 12 months
16338000|NCT00363831|Drug|Oxaliplatin|130mg/m² infusion day 1, repeat every 21 days
16338001|NCT00363805|Dietary Supplement|green tea|Given orally
16338002|NCT00363805|Drug|Polyphenon E|Given orally
16338003|NCT00363805|Other|placebo|Given orally
16338004|NCT00363792|Drug|Glyceryl trinitrate, azetazolamide|
16338005|NCT00363779|Drug|Cyclosporine|An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic levels shall be maintained for 3 months.
16338006|NCT00363779|Genetic|Gene expression analysis|A permutation test will be performed to examine whether the overall expression profile changes due to treatment. This will be done by comparing the number of significant genes to the distribution of this number if in fact there is no difference between pre-treatment and post-treatment gene expression.
16338007|NCT00363779|Genetic|Microarray analysis|Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and posttreatment samples.
16338239|NCT00361985|Drug|Esomeprazole|Esomeprazole 40mg once daily orally
16338008|NCT00363779|Other|Laboratory biomarker analysis|Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine.
16338009|NCT00363766|Drug|LY573636-sodium|A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.
16338010|NCT00363753|Drug|aspirin versus clopidogrel|
16338011|NCT00363740|Drug|GW685698X Aqueous Nasal Spray|
16338012|NCT00363727|Drug|ropinirole controlled-release (REQUIP CR) for RLS|
16338013|NCT00363714|Drug|AGN211745|100microgram single intravitreal injection
16338014|NCT00363714|Drug|AGN211745|200microgram single intravitreal injection
16338015|NCT00363714|Drug|AGN211745|400microgram single intravitreal injection
16338016|NCT00363714|Drug|AGN211745|800microgram single intravitreal injection
16338017|NCT00363714|Drug|AGN211745|1200microgram single intravitreal injection
16338018|NCT00363714|Drug|AGN211745|1600microgram single intravitreal injection
16338019|NCT00363701|Drug|esomeprazole|
16338020|NCT00363688|Drug|Penicillin test and challenge|
16338021|NCT00363675|Behavioral|Functional hand tests|Chilren were tested after healed hand burns for functional ability.
16338022|NCT00363649|Biological|GM-K562 cell vaccine|Given by injection
16338023|NCT00363649|Biological|Interferon alfa|Given by injection
16338024|NCT00363649|Biological|Sargramostim|Given by injection
16338025|NCT00363636|Drug|Galiximab in combination with rituximab|Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
16338026|NCT00363636|Drug|Rituximab in combination with placebo|Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
16338027|NCT00363623|Device|Silicone hydrogel contact lens|
16338028|NCT00363610|Drug|Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma|
16338029|NCT00363584|Drug|capecitabine|
16338030|NCT00363584|Other|clinical observation|
16338031|NCT00363584|Procedure|adjuvant therapy|
16338032|NCT00363571|Drug|GTN, Diamox|
16338033|NCT00363545|Biological|Lyophilized formulation of HRV vaccine|Lyophilized formulation of HRV vaccine
16338034|NCT00363545|Biological|Liquid formulation of HRV vaccine|Liquid formulation of HRV vaccine
16338035|NCT00363532|Drug|infusion of calcitonin gene related peptide (CGRP)|
16338036|NCT00363519|Drug|Placebo|Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
16338037|NCT00363519|Drug|Sitagliptin phosphate|Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
16338038|NCT00363506|Behavioral|Serotona Plus and dietary behavior management|
16338039|NCT00363480|Drug|Salmeterol/Fluticasone 50/250 mcg|Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.
16338040|NCT00363480|Drug|Salbutamol 100 mcg|This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.
16338041|NCT00363480|Device|DISKUS™ powder inhalers|Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.
16338042|NCT00363467|Drug|G-CSF|"Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously.
~Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously."
16338043|NCT00363467|Drug|Leukapheresis|leukapheresis
16338044|NCT00363467|Drug|Busulfan|Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2
16338045|NCT00363467|Procedure|Stem cell reinfusion|autologous stem cell transplant
16338046|NCT00363454|Drug|Triciribine Phosphate Monohydrate|8 Cycles @ 28 days. Level 1: 15 mg/m^2; Level 2: 25 mg/m^2; 35 mg/m^2; 45 mg/m^2.
16338047|NCT00363441|Procedure|Intensity Modulated Radiotherapy|
16338048|NCT00363428|Behavioral|exercise intervention|life style
16338049|NCT00363428|Behavioral|smoking cessation intervention|Life style
16338050|NCT00363428|Other|counseling intervention|life style
16338051|NCT00363428|Other|educational intervention|life style
16338052|NCT00363428|Procedure|conventional surgery|life style
16338053|NCT00363428|Procedure|pulmonary complications management/prevention|life style
16338054|NCT00363415|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles
16338055|NCT00363415|Drug|etoposide|100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
16338056|NCT00363415|Drug|carboplatin|Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
16338057|NCT00363402|Procedure|PET-CT|
16338058|NCT00363389|Drug|misoprostol and cervical ripening|
16338059|NCT00363376|Drug|zonisamide|Zonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea).
16338060|NCT00363376|Drug|olanzapine|olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects
16338061|NCT00363376|Drug|Zonisamide|zonisamide ranging from 100mg to 600mg daily
16338062|NCT00363376|Drug|Sugar Pill (placebo)|sugar pill (placebo) for zonisamide
16338125|NCT00362908|Behavioral|Moderate Fat and Moderate Carbohydrate Diet|40% allowable fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
16338126|NCT00362908|Behavioral|Low Fat and High Carbohydrate Diet|20% fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
16338127|NCT00362895|Drug|Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension|One drop in the study eye, single dose
16338240|NCT00361972|Drug|lansoprazole|30 mg of lansoprazole twice daily for 6 weeks
16338063|NCT00363363|Behavioral|Physical Activity|Children in this arm of the study will be provided with specific activities to be completed on most days of the week. The selected activities will be based on the child's interests and results of the baseline measures of health-related PA, MVPA and gross motor skill. The resources and facilities available to the family and season of the year will also influence the choice of activities. The frequency and duration of the required activities will be gradually increased until the child's baseline MVPA has been increased by a minimum of 30 minutes per day, most days of the week. Once that increase is achieved, the activities will be modified to maintain and reinforce the higher PA level.
16338064|NCT00363363|Behavioral|Education|Children in this arm of the study will be provided with puzzles, stories and games to be completed each week. The selected activities will be based on the child's interests and designed to increase the child's knowledge of activity options, perceptions of activity benefits, self-confidence for activity participation and motivation for daily activity. The activities introduced will vary with the resources available to the family and the season of the year, and will include information about healthy eating, injury prevention, and healthy lifestyle options.
16338065|NCT00363350|Drug|rituximab (anti-CD20)|2 infusions of 1000 mg
16338066|NCT00363337|Drug|aripiprazole|open label treatment with aripiprazole
16338067|NCT00363324|Procedure|intracoronary injection of bone marrow cells|
16338068|NCT00363311|Drug|Dutasteride|Dutasteride 0.5mg
16338069|NCT00363311|Drug|Matching placebo|Matching placebo
16338070|NCT00363298|Drug|dextro-amphetamine|dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
16338071|NCT00363298|Drug|Sham Comparison|caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks
16338072|NCT00363285|Biological|gonadotrophin releasing hormone|
16338073|NCT00363285|Drug|cyproterone acetate|
16338074|NCT00363285|Procedure|quality-of-life assessment|
16338075|NCT00363272|Drug|ispinesib|Given IV
16338076|NCT00363272|Other|laboratory biomarker analysis|Correlative studies
16338077|NCT00363272|Other|pharmacological study|Correlative studies
16338078|NCT00363259|Drug|Peginterferon alfa-2b|
16338079|NCT00363259|Drug|Ribavirin|
16338080|NCT00363233|Drug|flax lignans|
16338081|NCT00363194|Drug|Pazopanib (GW786034)|Pazopanib (GW786034)
16338082|NCT00363168|Drug|Ranibizumab|0.3 mg/0.05 ml dose
16338083|NCT00363168|Drug|Ranibizumab|0.5 mg/0.05 ml dose
16338084|NCT00363155|Drug|KRN7000|
16338085|NCT00363142|Drug|Half-boosted Fosamprenavir|Once daily, reduced dose ritonavir-boosted fosamprenavir
16338086|NCT00363142|Drug|Full Boosted Fosamprenavir|Full ritonavir-boosted fosamprenavir
16338087|NCT00363129|Dietary Supplement|vitamin E|Given orally
16338088|NCT00363129|Other|placebo|Given orally
16338089|NCT00363116|Drug|Daclizumab|daclizumab 1 mg/kg/dose every 14 days for 5 doses
16338090|NCT00363090|Biological|alemtuzumab|
16338091|NCT00363090|Drug|cyclophosphamide|
16338092|NCT00363090|Drug|doxorubicin hydrochloride|
16338093|NCT00363090|Drug|prednisone|
16338094|NCT00363090|Drug|vincristine sulfate|
16338095|NCT00363090|Other|flow cytometry|
16338096|NCT00363090|Other|pharmacological study|
16338097|NCT00363077|Biological|GSK1247446A Group|Low dose influenza vaccine adjuvanted with AS03 compared
16338098|NCT00363077|Biological|Fluarix™|GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.
16338099|NCT00363051|Drug|Everolimus 10 mg|Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
16338100|NCT00363051|Drug|Octreotide Depot|
16338101|NCT00363038|Drug|Petrolatum United States Pharmacopeia (USP)|Topical formation applied to bruise twice daily for 2 weeks.
16338102|NCT00363038|Drug|Vitamin K and retinol ointment|Topical formation applied to bruise twice daily for 2 weeks.
16338103|NCT00363038|Drug|Arnica ointment|Topical formation applied to bruise twice daily for 2 weeks.
16338104|NCT00363038|Drug|Vitamin K ointment|Topical formation applied to bruise twice daily for 2 weeks.
16338105|NCT00363025|Procedure|Two post-remission strategies|
16338106|NCT00363025|Drug|Idarubicin versus daunorubicin|
16338107|NCT00363012|Biological|HER-2/neu intracellular domain protein|300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.
16338108|NCT00363012|Other|flow cytometry|This is a laboratory test used to assess the antigen specific T cell population.
16338109|NCT00363012|Other|immunohistochemistry staining method|This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
16338110|NCT00363012|Procedure|biopsy|A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
16338111|NCT00363012|Other|Sterile water placement|100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.
16338112|NCT00362986|Drug|sunscreen|
16338113|NCT00362986|Other|placebo|
16338114|NCT00362973|Other|laboratory biomarker analysis|
16338115|NCT00362973|Procedure|needle biopsy|
16338116|NCT00362973|Procedure|positron emission tomography|
16338117|NCT00362973|Procedure|radionuclide imaging|
16338118|NCT00362973|Radiation|fludeoxyglucose F 18|
16338119|NCT00362960|Drug|Olmesartan medoxomil|
16338120|NCT00362960|Drug|Losartan|
16338121|NCT00362947|Drug|LMWH parnaparin subcutaneously|
16338122|NCT00362934|Drug|fenofibrate / simvastatin|Combination of fenofibrate and simvastatin 20 mg and 40 mg
16338123|NCT00362934|Drug|Atorvastatin|Atorvastatin 10 mg and 20mg
16338124|NCT00362921|Drug|Gliadel wafers in combination with O6-benzylguanine|
16348817|NCT00275509|Drug|Daclizumab|
16338128|NCT00362895|Drug|Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)|One drop in the study eye, single dose
16338129|NCT00362882|Drug|docetaxel|Given IV
16338130|NCT00362882|Drug|bortezomib|Given IV
16338131|NCT00362882|Other|laboratory biomarker analysis|correlative study
16338132|NCT00362882|Other|immunoenzyme technique|correlative study
16338133|NCT00362882|Other|immunohistochemistry staining method|correlative study
16338134|NCT00362882|Other|pharmacological study|correlative study
16338135|NCT00362869|Drug|Levofloxacin|Administered at a dose of 500 mg once a day for 3 days
16338136|NCT00362869|Drug|Placebo|Sodium bicarbonate solution
16338137|NCT00362869|Biological|Enteroaggregative E. coli (EAEC)|Dosages: 1X10^9, 5X10^9, 1X10^10, and 5X10^10 cfu; given in a sodium bicarbonate solution
16338138|NCT00362856|Drug|larazotide acetate|capsule
16338139|NCT00362856|Drug|Placebo|capsule
16338140|NCT00362830|Drug|vinflunine + ixabepilone|solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
16338141|NCT00362817|Drug|carboplatin|IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
16338142|NCT00362817|Drug|temozolomide|150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.
16338143|NCT00362804|Drug|Tetrabenazine|The initial TBZ dose will be 12.5 mg and the dose will be increased to 25 mg at Week 2. Thereafter, the dose can be decreased to 12.5 mg or increased in 12.5 mg increments at weekly intervals, depending on clinical response and tolerability, to a maximum of 75 mg/day. For 37.5 and 50 mg daily, administration will be BID i.e., 25 mg QAM, 12.5 or 25 mg QHS. For 62.5 or 75 mg daily, a TID dosing will be employed i.e., 25 mg QAM, 12.5 or 25 mg QPM, 25 mg QHS
16338144|NCT00362791|Behavioral|"Enhanced HIV/STD Counseling: 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model"|
16338145|NCT00362791|Behavioral|"Brief Counseling (aka client-centered counseling): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior"|
16338146|NCT00362791|Behavioral|"HIV Prevention Education: 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies"|
16338147|NCT00362778|Drug|Insulin|intravenous continuous insulin infusion for 48 hours
16338148|NCT00362765|Drug|Fenofibrate|160 mg
16338149|NCT00362765|Drug|Metformin|2000 mg
16338150|NCT00362765|Drug|Placebo|Placebo
16338151|NCT00362752|Drug|Norfloxacin|400 mg po bid
16338152|NCT00362752|Drug|Placebo|Placebo 400 mg po bid
16338153|NCT00362726|Drug|Rosiglitazone maleate|Tablets, Oral, RGZ 4 mg, once daily, 1 day.
16338154|NCT00362726|Drug|Atazanavir Sulphate|Capsules, Oral, ATV 400 mg, once daily, 5 days.
16338155|NCT00362726|Drug|Atazanavir Sulphate + Rosiglitazone maleate|Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
16338156|NCT00362726|Drug|Atazanavir Sulphate + Ritonavir|Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
16338157|NCT00362726|Drug|Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate|Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
16338158|NCT00362713|Drug|Ipilimumab|Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24
16338159|NCT00362700|Drug|Clevudine|
16338160|NCT00362687|Drug|Truvada (TDF+FTC) alone|tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation
16338161|NCT00362687|Drug|FTC alone|emtricitabine 200 mg
16338162|NCT00362687|Procedure|No HAART|No HAART
16338163|NCT00362661|Drug|Cortisol|Cortisol 10 mg/d for 3 months
16338164|NCT00362648|Biological|RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent|2.0 mL oral dose of RotaTeq™. 14 week treatment period
16338165|NCT00362648|Biological|Comparator: Placebo|Arm 2: Placebo. 14 week treatment period
16338166|NCT00362635|Drug|Clevudine|
16338167|NCT00362609|Drug|pantoprazole|
16338168|NCT00362596|Drug|acyclovir|
16338169|NCT00362583|Drug|Fentanyl|
16338170|NCT00362570|Drug|Temozolomide|"p.o.(by mouth), 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off] using a standardized dosing range.
~Administration: Temozolomide will be administered on an empty stomach (i.e., 1 hour before or 2 hours after any oral intake)."
16338171|NCT00362557|Device|MRI|Magnetic resonance imaging
16338172|NCT00362544|Drug|Ambisome|
16338173|NCT00362531|Drug|tacrolimus combined with prednisone|
16338174|NCT00362518|Dietary Supplement|Study Arm A|Control: no vitamins (placebo only). This study will provide baseline metabolic and surrogate marker changes that are caused by the high fat meal. Study arms B, C, and D will be statistically compared to this study.
16338175|NCT00362518|Dietary Supplement|Study Arm B|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a low dosage form of vitamin C is administered (250 mg) and Vitamin E (200 IU).
16338176|NCT00362518|Dietary Supplement|Study Arm C|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a medium dosage form of vitamin C administered (500 mg)and Vitamin E (400 IU).
16338177|NCT00362518|Dietary Supplement|Study Arm D|This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a high dosage form of vitamin C is administered (1000 mg) and Vitamin E (800 IU).
16338178|NCT00362505|Drug|Clevudine|
16338179|NCT00362492|Procedure|Bilateral ultrasound examination 7+/- 2 after surgery|
16338180|NCT00362479|Drug|DR-1021|1 tablet daily
16338181|NCT00362466|Drug|Dasatinib|Tablets, Oral, Once daily, 5-7 years
16338182|NCT00362466|Drug|Imatinib|Tablets, Oral, Once daily, 5-7 years
16338183|NCT00362453|Behavioral|Tai Chi versus Attention Control|60 minutes, twice a week for 12 weeks.
16338184|NCT00362440|Drug|Leptin|
16338185|NCT00362440|Drug|Pioglitazone or metformin|
16338186|NCT00362440|Drug|Placebo|
16338187|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 mL, 4 doses, IM
16338188|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 Ml, 4 doses, IM
16338189|NCT00362427|Biological|Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC|0.5 mL, 4 doses, IM with concommitant vaccines
16349046|NCT00274118|Drug|enalapril|
16338190|NCT00362414|Drug|Dual Growth Factor|"10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
16338191|NCT00362388|Procedure|Intramyocardial injection of autologous bone marrow cells|
16338192|NCT00362375|Behavioral|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
16338193|NCT00362375|Behavioral|HIV/AIDS 101 Workshop|The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW. The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing. However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW.
16338194|NCT00362349|Drug|IgNextGen 10%|"Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens:
~Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days.
~Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days"
16338195|NCT00362336|Biological|DTaP-IPV-HB-PRP~T|0.5 mL, Intramuscular (IM)
16338196|NCT00362336|Biological|CombAct-HIB®|0.5 mL, IM
16338197|NCT00362336|Biological|Engerix B® Pediatric|0.5 mL, IM
16338198|NCT00362323|Drug|fenofibrate (F) + metformin (M) hydrochloride fixed combination|F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
16338199|NCT00362323|Drug|Metformin|500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks
16338200|NCT00362310|Drug|indinavir|
16338201|NCT00362297|Drug|acyclovir|800 mg orally three times daily for 7 weeks
16338202|NCT00362297|Drug|valacyclovir|500 mg orally once daily for 7 weeks
16338203|NCT00362284|Behavioral|NYUCI-AC|Approximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention
16338204|NCT00362271|Drug|Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.|Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.
16338205|NCT00362258|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
16338206|NCT00362245|Drug|Systemic and Intra-Thecal Amikacin Therapy|
16338207|NCT00362232|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.
16338208|NCT00362232|Drug|Enoxaparin|Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
16338209|NCT00362232|Drug|Placebo: tablet of Rivaroxaban|Placebo tablet of rivaroxaban administered once daily in the evening.
16338210|NCT00362232|Drug|Placebo: syringes of Enoxaparin|Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
16338211|NCT00362219|Other|Placebo|Gel with no active ingredient.
16338212|NCT00362219|Drug|Morphine - .25 mg|gel with 0.25 mg morphine per 100cm2 square of wound.
16338213|NCT00362219|Drug|Morphine|Gel with 0.75 mg morphine per 100cm2 square of wound.
16338214|NCT00362219|Drug|Morphine|Gel with 1.25 mg morphine per 100cm2 square of wound.
16338215|NCT00362206|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 20mg
16338216|NCT00362206|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40 mg
16338217|NCT00362206|Drug|Pravastatin|Pravastatin 40 mg
16338218|NCT00362193|Behavioral|Telephonic diabetes care|
16338219|NCT00362180|Drug|mipomersen|200 mg subcutaneous injections
16338220|NCT00362180|Drug|Placebo|subcutaneous injections
16338221|NCT00362141|Drug|levetiracetam (add-on)|
16338222|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338223|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338224|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338225|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338226|NCT00362115|Drug|Azilsartan Medoxomil|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338227|NCT00362115|Drug|Olmesartan|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
16338228|NCT00362115|Drug|Placebo|Matching placebo tablets, orally, once daily for up to 8 weeks.
16338229|NCT00362102|Drug|Cetuximab|
16338230|NCT00362089|Dietary Supplement|Marinol D-40|Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
16338231|NCT00362063|Drug|growth hormone (Nutropin)|growth hormone (Nutropin), 0.3mg/kg/week administered subcutaneously daily.
16338232|NCT00362050|Drug|Treatment with 3 dose groups of RBx11160 over 7 days|
16338233|NCT00362037|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
16338234|NCT00362024|Drug|MK0952|
16338235|NCT00362024|Drug|Comparator: Placebo|
16338236|NCT00362011|Behavioral|Salba diet|
16338237|NCT00361998|Drug|NITROFURANTOIN MACROCRYSTALS|
16338241|NCT00361972|Drug|placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
16338242|NCT00361959|Drug|Tiotropium bromide 18mcg|
16338243|NCT00361959|Drug|Fluticasone propionate/ salmeterol combination 50/500mcg|
16338244|NCT00361933|Drug|Valganciclovir|valganciclovir open label, two 450mg tablets orally, twice a day
16338245|NCT00361920|Drug|prednisone|
16338246|NCT00361907|Procedure|Effect of Pulsatile IV insulin on diabetic pt blood markers|Diabetic patients are given pulsatile intravenous insulin on a weekly basis determined by weekly physician order based on pt response and insulin resistance.
16338247|NCT00361907|Procedure|Effect of Pulsatile IV Insulin on blood markers|Circulating blood markers are performed at baseline and every twelve months to compare and measure against diabetic patients receiving pulsatile intravenous insulin.
16338248|NCT00361907|Procedure|Effect of Pulsatile IV insulin on diabetic pt blood markers|Blood markers will be performed on diabetic patients enrolled as control patients at baseline and every twelve months to measure and compare against diabetic patients treated with Pulsatile intravenous insulin therapy
16338249|NCT00361894|Drug|Rivaroxaban (BAY59-7939)|10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
16338250|NCT00361894|Drug|Enoxaparin|Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
16338251|NCT00361881|Drug|ME-609|Cream, dose 5 times daily during 5 days.
16338252|NCT00361881|Drug|acyclovir in ME-609 vehicle|Dose 5 times daily for 5 days
16338253|NCT00361881|Drug|Vehicle|Dose 5 times daily for 5 days
16338254|NCT00361868|Drug|fenofibrate (F) + metformin (M) hydrochloride fixed combination|First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
16338255|NCT00361868|Drug|Rosiglitazone|First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
16338256|NCT00361855|Drug|NX-CP105|
16338257|NCT00361842|Drug|CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection|CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
16338258|NCT00361803|Drug|topotecan|topotecan
16338259|NCT00361790|Drug|Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg|Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.
16338260|NCT00361751|Drug|fenofibrate|
16338261|NCT00361738|Drug|AVE2268|
16338262|NCT00361712|Procedure|Preemptive epidural analgesia|Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.
16338263|NCT00361712|Drug|Standard of care|Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
16338264|NCT00361699|Drug|Statin|
16338265|NCT00361686|Drug|tramadol|
16338266|NCT00361686|Drug|remifentanyl|
16338267|NCT00361686|Device|patient contolled analgesia|
16338268|NCT00361660|Behavioral|functional task practice - distributed|This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
16338269|NCT00361660|Behavioral|functional task practice - condensed|This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
16338270|NCT00361647|Procedure|Diagnostic screening for occult malignancy|
16338271|NCT00361634|Drug|Etanercept|
16338272|NCT00361621|Drug|bortezomib|Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles
16338273|NCT00361621|Drug|Rituximab|Given intravenously on day 1 of a 21-day cycle for 6 cycles
16338274|NCT00361621|Drug|Cyclophosphamide|Given intravenously on day 1 of a 21-day cycle for 6 cycles
16338275|NCT00361621|Drug|Doxorubicin|Given intravenously on day 1 of a 21-day cycle for 6 cycles
16338276|NCT00361621|Drug|Vincristine|Given intravenously on day 1 of a 21-day cycle for 6 cycles
16338277|NCT00361621|Drug|Prednisone|Taken orally on days 2, 3, 4 and 5 or a 21-day cycle for 6 cycles
16338278|NCT00361621|Radiation|Radiation therapy|After 6 cycles of chemotherapy there will be 3 weeks of radiation therapy
16338279|NCT00361608|Device|EarlySense ES 16|
16338280|NCT00361595|Drug|zoledronic acid|5 mg zoledronic acid administered in a single 15 minute IV
16338281|NCT00361582|Drug|CG5503 IR; tapentadol|
16338282|NCT00361569|Drug|DR-2041a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
16338283|NCT00361569|Drug|DR-2041b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
16338284|NCT00361569|Other|Placebo|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
16338285|NCT00361569|Other|Placebo|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
16338286|NCT00361556|Behavioral|The Back Book|A book on how to prevent back pain
16338287|NCT00361556|Behavioral|The Back Guide|A guide for the prevention of back pain.
16338288|NCT00361556|Behavioral|General health book|A book on general health
16338289|NCT00361543|Drug|Raloxifene hydrochloride|120 mg per capsule (1 tablet daily)
16338290|NCT00361543|Other|Lactose Capsules|1 tablet daily for 12 weeks
16338291|NCT00361530|Drug|Statin|
16338292|NCT00361517|Behavioral|Galactomannan antigen monitoring, Aspergillus PCR|There will be blood draws twice weekly for monitoring GM antigen and once a week for Aspergillus PCR.
16338293|NCT00361517|Other|blood draws|Blood is drawn for monitoring of Galactomannan antigen in the blood
16338294|NCT00361517|Other|blood draws for GM monitoring|blood samples will be taken twice weekly for monitoring of GM antigen levels in the blood and once a week for Aspergillus PCR.
16338295|NCT00361517|Drug|Amphotericin-B deoxycholate|1-1.5mg/kg, i.v, once a day
16338296|NCT00361517|Other|blood test|Blood will be tested twice a week for the presence of Galactomannan.
16338297|NCT00361517|Other|Blood test|Blood will be drawn twice a week and it will be tested for the presence of GM(a component of the cell wall of the mold Aspergillus which is released during growth)
16338298|NCT00361504|Drug|Oxycodone CR|Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.
16338299|NCT00361504|Drug|Tapentadol (CG5503) ER|Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.
16338300|NCT00361491|Drug|SSR149415|
16338301|NCT00361478|Behavioral|Exercise and education|Weekly exercise and education program for 8 weeks
16338302|NCT00361478|Behavioral|Education|Written educational material
16338303|NCT00361465|Other|EMG and Kinematics recording|"The experimental protocol envisages the recording of the movement and the bilateral recording of activity EMG during three types of tasks:
~discrete driving tasks: movements of inflection and extension of the wrist car-generated, or produced in answer to an imperative stimulus try driving repetitive: sequence of inflection-extension of the wrist unilateral, bilateral in phase and bilateral in opposition of phase.
~try driving complexes: movement of inflection and extension of the wrist with concurrent realization of a driving task controlatérale different, or of a cognitive task.
~For the Parkinsonian patients, these various tests will be carried out twice: without antiparkinsonian treatment (off) and under treatment (one)."
16338304|NCT00361452|Drug|nebulized epinephrine and nebulized albuterol|
16338305|NCT00361439|Drug|Mometasone|2 puffs in each nostril once daily of nasal spray
16338306|NCT00361439|Drug|Placebo|2 puffs in each nostril once daily of nasal spray
16338307|NCT00361426|Device|Earlysense vital sign monitor|The system is a contactless system that measures heart and respiratory rates and other parameters via a contactless sensor that is placed under the patient mattress
16338308|NCT00361413|Drug|Alefacept (AMEVIVE®)|Alefacept
16338309|NCT00361413|Drug|control group|these patients will receive the same treatment as group A, without alefacept
16338310|NCT00361387|Drug|d-methylphenidate|oral dosing for 8 weeks then cross over to placebo in random order
16338311|NCT00361374|Dietary Supplement|eicosapentaenoic acid|1 gram/day
16338312|NCT00361374|Dietary Supplement|docosahexaenoic acid|1 gram/day
16338313|NCT00361374|Drug|Placebo|980 milligram/day
16338314|NCT00361361|Device|Excimer Laser Therapy|excimer laser is a UV 308nm laser. repeated sessions (10 sessions) needed. once per week.
16338315|NCT00361348|Drug|Palifermin|
16338316|NCT00361348|Drug|Heparin|
16338317|NCT00361335|Drug|Golimumab|2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
16338318|NCT00361335|Drug|Methotrexate|Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
16338319|NCT00361335|Drug|Placebo|Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
16338320|NCT00361322|Drug|clindamycin phosphate|
16338321|NCT00361322|Drug|salicylic acid|
16338322|NCT00361309|Drug|SU011248|Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).
16338323|NCT00361296|Biological|K562/GM-CSF cell vaccine|
16338324|NCT00361283|Drug|Atorvastatin|atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
16338325|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
16338326|NCT00361270|Behavioral|Hyp-2 w recordings|2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
16338327|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
16338328|NCT00361270|Behavioral|Hyp-8 w recordings|8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
16338329|NCT00361270|Behavioral|Hyp-2 w recordings|2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
16338330|NCT00361270|Behavioral|Hyp-8|8 weekly 1-hour sessions of therapist-guided hypnosis
16338331|NCT00361270|Behavioral|Hyp-8 w recordings|8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
16338332|NCT00361270|Behavioral|BIO|8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
16338333|NCT00361257|Drug|Minocycline|Tetracycline antibiotic, 100 mg taken orally every 12 hours
16338334|NCT00361257|Drug|Placebo (Tetracycline)|Tetracycline antibiotic placebo, orally every 12 hours
16338335|NCT00361244|Drug|SU011248|Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
16338336|NCT00361244|Drug|Irinotecan|Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
16338337|NCT00361244|Drug|Cetuximab|Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
16338338|NCT00361231|Drug|Bevacizumab|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
16338339|NCT00361231|Drug|Gemcitabine|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
16338340|NCT00361231|Drug|Oxaliplatin|Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
16338384|NCT00360945|Other|laboratory biomarker analysis|
16338385|NCT00360945|Radiation|radiation therapy|
16339083|NCT00355329|Procedure|Tongue Acupuncture (Procedure)|
16338341|NCT00361218|Drug|open-label selective serotonin reuptake inhibitor (SSRI)|Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
16338342|NCT00361205|Device|Electronic Monitoring cap|
16338343|NCT00361192|Procedure|biopsy of temporal artery|
16338344|NCT00361166|Drug|ACP-103|
16338345|NCT00361153|Drug|Colesevelam hydrochloride|Welchol tablet 625mg
16338346|NCT00361153|Drug|placebo|placebo
16338347|NCT00361140|Drug|Busulfan|"Bu IV (BusulfexR) over 3 hours on days -6, -5, -4, and -3. Day -6 and -5 doses for patients on Level 1 will be 170mg/m2. This dose is based on the dose used by DeLima (2004) adjusted proportionately to achieve an AUC of 6000uM-min. Subsequent daily doses for patients on Level 1 will be adjusted to achieve an average AUC of 6000uM-min.
~Day -6 and -5 doses for patients on Level 2 will be based on the mean dose required on Level 1 to achieve target AUC then adjusted proportionally for new target AUC.
~Subsequent daily doses will be adjusted to achieve target AUCs."
16338348|NCT00361140|Drug|Fludarabine|Fludarabine 40mg/m2 IV over 1 hour on days -6, -5, -4, and -3
16338349|NCT00361127|Drug|isotonic saline infusion|
16338350|NCT00361114|Drug|sulphadoxine/pyrimethamine|Sulfadoxine/pyremethamine (SP) given as a single dose per manufacturers recommendation (tablets 500mg sulphadoxine and 15mg pyremethamine; child's body weight 5-10Kgs ½ tablet, 11-20Kgs 1 tablet, 21-30 Kgs 1 ½ tablets)
16338351|NCT00361114|Drug|Chlorproguanil/dapsone|Chlorproguanil/ dapsone (CD) given daily for 3 days per manufacturers recommendations (tablets chlorproguanil 15mg/ dapsone 18.75 mg; 5-7.9Kgs 1 tablet, 8-11.9 Kg 1 ½ tablets, 12-15.9 2 tablets, 16-20.9 Kgs 2 ½ tablets, 21- 40Kg 5 tablets).
16338352|NCT00361114|Drug|Sulfadoxine/pyrimethamine|Sulfadoxine/pyremethamine (SP) given as a single dose per manufacturers recommendation (tablets 500mg sulphadoxine and 15mg pyremethamine; child's body weight 5-10Kgs ½ tablet, 11-20Kgs 1 tablet, 21-30 Kgs 1 ½ tablets)
16338353|NCT00361101|Drug|AMD11070|200 mg PO BID (by mouth two times per day) for 10 days.
16338354|NCT00361088|Drug|PS-341|Phase I and II: 1.3mg/m2 iv days 1,4,8,11
16338355|NCT00361088|Drug|R11577|"Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3.
~Phase II: Maximum Tolerated Dose (MTD)"
16338356|NCT00361075|Drug|transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)|
16338357|NCT00361062|Behavioral|comparative computer simulation|comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.
16338358|NCT00361049|Biological|graft versus host disease prophylaxis/therapy|Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
16338359|NCT00361049|Genetic|fluorescence in situ hybridization|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
16338360|NCT00361049|Other|immunoenzyme technique|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
16338361|NCT00361049|Other|immunohistochemistry staining method|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
16338362|NCT00361049|Other|laboratory biomarker analysis|Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
16338363|NCT00361049|Procedure|in vitro-treated bone marrow transplantation|Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
16338364|NCT00361049|Procedure|management of therapy complications|Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.
16338365|NCT00361036|Device|Uterine fibroid embolization BeadBlock™|Intervention with BeadBlock Microspehere
16338366|NCT00361036|Device|Uterine fibroid embolization Embosphere®|Embosphere - control arm
16338367|NCT00361023|Drug|losartan|
16338368|NCT00361010|Drug|Levetiracetam|
16338369|NCT00360997|Behavioral|Conventional UK physical therapy|
16338370|NCT00360997|Procedure|Con UK PT + Mobilisation & tactile stimulation (MTS)|Con UK PT + Mobilisation & Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day
16338371|NCT00360984|Drug|insulin glargine|
16338372|NCT00360984|Device|continuous subcutaneous insulin infusion|
16338373|NCT00360971|Biological|palifermin|Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
16338374|NCT00360971|Drug|cisplatin|Patients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course.
16338375|NCT00360971|Other|placebo|Four doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
16338376|NCT00360971|Procedure|neck dissection|A neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline.
16338377|NCT00360971|Radiation|radiation therapy|A radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment.
16338378|NCT00360958|Procedure|ultrafiltration|
16338379|NCT00360945|Drug|cisplatin|
16338380|NCT00360945|Drug|temozolomide|
16338381|NCT00360945|Genetic|fluorescence in situ hybridization|
16338382|NCT00360945|Genetic|loss of heterozygosity analysis|
16338383|NCT00360945|Other|immunohistochemistry staining method|
16338386|NCT00360932|Device|SCULPTRA (poly-L-lactic acid injection)|Subjects will be treated with SCULPTRA® according to the investigator's judgment, and in accordance with the SCULPTRA® package insert. Details of the exact amount and the time of administration of SCULPTRA® (date, amount, location) will be documented in the CRF at each protocol and non-protocol visit.
16338387|NCT00360919|Behavioral|cheese ingestion|"On study day 1, approximately half of the participants will consume a breakfast of fruits and vegetables, whereas the other half of participants will consume a meal consisting of 9 oz. of cheese.
~Blood samples will be collected from participants immediately prior to consumption of the meals, and then again at regular intervals for up to 8 hours following the meals.
~At least 3 days later, participants will return for study Day 2. The participants will receive the second meal. Blood samples will then be collected immediately prior to consumption of the test meal and for up to 8 hours after the meal."
16338388|NCT00360906|Drug|Triomar™ (omega-3 fatty acids)|
16338389|NCT00360867|Drug|AMG 706|The dose of AMG 706 will be administered at the same dose level and schedule received at the conclusion of the previous study but will be no greater than 125 mg QD or 75 mg BID.
16338390|NCT00360854|Drug|erlotinib hydrochloride|
16338391|NCT00360854|Genetic|mutation analysis|
16338392|NCT00360854|Genetic|polymorphism analysis|
16338393|NCT00360854|Other|laboratory biomarker analysis|
16338394|NCT00360854|Other|pharmacological study|
16338395|NCT00360854|Radiation|radiation therapy|
16338396|NCT00360841|Procedure|Auricular acupuncture|Subjects will be randomized to one of these arms. The subjects in arm A and B will receive auricular acupuncture. Before subjects receive chemotherapy within one day, they will be treated by auricular acupuncture, sham acupuncture, or control group.
16338397|NCT00360841|Procedure|Sham auricular acupuncture|
16338398|NCT00360828|Drug|Irinotecan Hydrochloride (HCI) Treatment|Irinotecan injections. Irinotecan hydrochloride [CPT-11; CAMPTOSAR] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.
16338399|NCT00360828|Drug|Continued Irinotecan Hydrochloride (HCI) Treatment|For patients responding to treatment, therapy could have continued beyond 18 cycles.
16338400|NCT00360815|Behavioral|Insulin|
16338401|NCT00360802|Behavioral|Cognitive Behavioral Treatment|Behavioral treatment to reduce pain in chronic back pain patients
16338402|NCT00360802|Behavioral|Mindfulness Based Stress Reduction|Behavioral treatment to reduce pain in chronic back pain patients
16338403|NCT00360789|Behavioral|Conventional UK physical therapy|
16338404|NCT00360789|Behavioral|Increased intensity of UK conventional physical therapy (PT)|
16338405|NCT00360789|Behavioral|UK conventional PT plus functional strength training|
16338406|NCT00360776|Drug|tipifarnib|Given orally
16338407|NCT00360776|Other|laboratory biomarker analysis|Correlative studies
16338408|NCT00360763|Drug|candesartan cilexetil|
16338409|NCT00360750|Drug|carboplatin|
16338410|NCT00360750|Drug|cytarabine|
16338411|NCT00360750|Drug|etoposide|
16338412|NCT00360750|Drug|vincristine sulfate|
16338413|NCT00360750|Other|clinical observation|
16338414|NCT00360750|Procedure|adjuvant therapy|
16338415|NCT00360750|Radiation|radiation therapy|
16338416|NCT00360737|Biological|Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)|Biological/Vaccine NP-018 Experimental with 8 Cohorts of 5 Subjects each evaluating 2 Dosage levels of 1 or 2 vials of NP-018 administered intravenously.
16338417|NCT00360724|Drug|Duloxetine (Cymbalta)|duloxetine medication up to dose of 120 mg/day
16338418|NCT00360698|Drug|Insulin Glargine|One daily injection at bedtime
16338419|NCT00360698|Drug|Glimepiride|At same dosage as during the run-in period
16338420|NCT00360698|Drug|Insulin Glulisine|One bolus given before the main meal
16338421|NCT00360698|Drug|Metformin|At same dosage as during the run-in period
16338422|NCT00360685|Drug|Tac+MTX|Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.
16338423|NCT00360685|Drug|TAC + MMF|Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant
16338424|NCT00360672|Drug|Revlimid|25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
16338425|NCT00360659|Device|Continuous Positive Airway Pressure|
16338426|NCT00360607|Drug|Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.|
16338427|NCT00360607|Drug|Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited|
16338428|NCT00360607|Drug|Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.|
16338429|NCT00360607|Drug|Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.|
16338430|NCT00360594|Drug|Acamprosate|3 pills (666 mg) for 1998mg/day
16338431|NCT00360594|Drug|Placebo|3 pills (666mg) for 1998mg/day
16338432|NCT00360581|Behavioral|Yoga|
16338433|NCT00360581|Behavioral|Yoga and Cognitive Behavioral Therapy|
16338434|NCT00360568|Drug|Levodopa-carbidopa intestinal gel|Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
16338435|NCT00360568|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16338436|NCT00360568|Device|PEG tube|percutaneous endoscopic gastrostomy tube
16338437|NCT00360568|Device|J-tube|jejunal tube
16338438|NCT00360555|Drug|flibanserin|flibanserin 25 mg b.i.d
16338439|NCT00360555|Drug|flibanserin 50mg|flibanserin 50mg qhs/b.i.d.
16338440|NCT00360555|Drug|flibanserin 100mg|flibanserin 50 mg b.i.d/100mg qhs
16338441|NCT00360555|Drug|placebo|placebo comparator
16338442|NCT00360529|Drug|flibanserin|flibanserin placebo versus 50 mg qhs versus 100 mg qhs
16338443|NCT00360516|Behavioral|metabolic (nutrient controlled) diet|metabolic (nutrient controlled) diet
16338647|NCT00358631|Drug|SSR149415|
16338648|NCT00358618|Drug|Propofol|See Detailed Description.
16338444|NCT00360490|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
16338445|NCT00360490|Drug|Medroxyprogesterone acetate|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
16338446|NCT00360477|Procedure|Floseal|Bioglue that seals the kidney
16338447|NCT00360477|Procedure|Cope Loop|Nephrostomy tube for fluid drainage from the kidney
16338448|NCT00360477|Procedure|Fascial Stitch|Stitch that closes the kidney
16338449|NCT00360464|Drug|Azithromycin SR|
16338450|NCT00360451|Behavioral|Adolescent only Penn Resiliency Program (Adolescent PRP)|In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation).
16338451|NCT00360451|Behavioral|Parent Penn Resiliency Program (Parent PRP)|Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.
16338452|NCT00360438|Drug|Rasburicase|0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.
16338453|NCT00360425|Drug|ferumoxytol|
16338454|NCT00360425|Drug|moxifloxacin|
16338455|NCT00360425|Drug|placebo|
16338456|NCT00360412|Drug|E2007|
16338457|NCT00360399|Drug|Escitalopram|Escitalopram 10 to 20 mg per day for 12 weeks
16338458|NCT00360399|Drug|Duloxetine|Duloxetine 30 to 60 mg per day for 12 weeks
16338459|NCT00360399|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 16 one-hour sessions provided over 12 weeks.
16338460|NCT00360386|Drug|Clopidogrel|
16338461|NCT00360360|Drug|paclitaxel|Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
16338462|NCT00360360|Drug|carboplatin|Carboplatin AUC 6.0 IV Day 1
16338463|NCT00360360|Drug|bevacizumab|Bevacizumab 15mg/kg IV infusion,Day 1
16338464|NCT00360360|Drug|erlotinib|Erlotinib 150 mg by mouth daily
16338465|NCT00360347|Drug|C.E.R.A.|
16338466|NCT00360334|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16338467|NCT00360334|Drug|insulin glargine|subcutaneous injection, titrated to target blood glucose level, once a day
16338468|NCT00360308|Drug|Placebo|
16338469|NCT00360308|Drug|E2007|
16338470|NCT00360308|Drug|E2007|
16338471|NCT00360295|Drug|Azithromycin SR|
16338472|NCT00360282|Drug|Rizatriptan|10 mg Rizatriptan in an unlabeled pill given once on one of two visits
16338473|NCT00360282|Other|Placebo|In an unlabeled pill given once on one of two visits.
16338474|NCT00360269|Drug|Atomoxetine|25 to 100 mg daily
16338475|NCT00360269|Procedure|Motivational enhancement therapy|Three sessions
16338476|NCT00360269|Drug|Placebo|25 to 100 mg daily
16338477|NCT00360243|Drug|flibanserin|Experimental: flibanserin 25 mg b.i.d
16338478|NCT00360243|Drug|flibanserin|Experimental: flibanserin 50mg qhs
16338479|NCT00360243|Drug|flibanserin|Experimental: flibanserin 50mg b.i.d.
16338480|NCT00360243|Drug|placebo|placebo
16338481|NCT00360230|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
16338482|NCT00360230|Biological|Rabipur|3-dose intramuscular injection.
16338483|NCT00360217|Drug|docosahexanoic acid (DHA)|
16338484|NCT00360204|Behavioral|Home Nurse Visit|Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
16338485|NCT00360191|Drug|Buspirone|
16338486|NCT00360191|Procedure|Motivational enhancement therapy|
16338487|NCT00360178|Drug|Valsartan plus Hydrochlorothiazide|
16338488|NCT00360178|Drug|Candesartan plus Hydrochlorothiazide|
16338489|NCT00360178|Drug|Amlodipine|
16338490|NCT00360152|Procedure|Fine needle aspiration biopsy (FNAB)|
16338491|NCT00360152|Procedure|Sentinel Lymph Node Biopsy|
16338492|NCT00360139|Device|Sculptra Injection|
16338493|NCT00360126|Drug|lamotrigine|
16338494|NCT00360100|Drug|Zmax|
16338495|NCT00360087|Drug|Bosentan|
16338496|NCT00360074|Drug|Thyroxin, Triiodothyronine|
16338497|NCT00360061|Behavioral|Cognitive Behaviour Therapy|
16338498|NCT00360048|Drug|oxytocin|
16338499|NCT00360035|Drug|Obatoclax mesylate (GX15-070MS)|60 mg q2wks
16338500|NCT00360022|Other|Joint visits|Both the pediatric GI specialist and the adult GI specialist will see the patient together at 2 different visits. The first joint visit is lead by the pediatric MD and the second joint visit is lead by the adult MD.
16338501|NCT00360009|Procedure|DBS of the STN|Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.
16338502|NCT00360009|Procedure|DBS of the GPI|Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.
16338503|NCT00359996|Behavioral|health disparities collaborative|The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
16338504|NCT00359996|Other|No additional educational sessions|
16338505|NCT00359983|Biological|MenHibrix (Hib-MenCY-TT)|First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
16338506|NCT00359983|Biological|Hib conjugate vaccine (ActHIB)|First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
16338507|NCT00359970|Drug|Azithromycin 500 mg|A single 500 mg dose at the start of treatment
16338508|NCT00359970|Drug|Azithromycin 1000 mg|A single 1000 mg dose at the start of treatment
16338509|NCT00359970|Drug|Loperamide|A single 4 mg loading dose at the start of treatment and then 2 mg after each loose stool
16338510|NCT00359970|Other|Placebo|A single loading dose at the start of treatment and then a dose after each loose stool
16338649|NCT00358605|Device|The Klearway™ oral appliance|See Detailed Description.
16338650|NCT00358592|Device|Mobius™ retractor|
16338511|NCT00359957|Behavioral|Pediatric Obesity Intervention (STANDARD)|14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
16338512|NCT00359957|Behavioral|Pediatric Obesity Intervention + High Activity (ADDED)|14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
16338513|NCT00359944|Drug|AC-3933|5mg twice daily
16338514|NCT00359944|Drug|AC-3933|AC-3933, 20 mg twice daily
16338515|NCT00359944|Other|Sugar Pill|Sugar Pill twice daily
16338516|NCT00359918|Drug|fibrinolysis|Primary PCI
16338517|NCT00359918|Procedure|Primary PCI|Primary PCI
16338518|NCT00359905|Drug|Silodosin|8 mg daily for 12 weeks
16338519|NCT00359905|Drug|Tamsulosin|0.4 mg daily for 12 weeks
16338520|NCT00359905|Drug|Placebo|once daily for 12 weeks
16338521|NCT00359892|Drug|Obatoclax mesylate (GX15-070MS)|60 mg q2wks
16338522|NCT00359879|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
16338523|NCT00359879|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
16338524|NCT00359866|Radiation|IMRT with tomotherapy|
16338525|NCT00359853|Drug|Oral norfloxacin|
16338526|NCT00359840|Drug|darbepoetin alfa|
16338527|NCT00359814|Drug|Mycophenolatmofetile|Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily
16338528|NCT00359814|Drug|Cyclosporin A|Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
16338529|NCT00359801|Drug|Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care|Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
16338530|NCT00359801|Drug|Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care|Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
16338531|NCT00359788|Drug|tiotropium|
16338532|NCT00359788|Drug|Combivent (Ipratropium/Albuterol)|
16338533|NCT00359775|Behavioral|Coping Skills Training|6 session behavioral program
16338534|NCT00359762|Drug|exenatide|subcutaneous injection (5mcg or 10mcg), twice a day
16338535|NCT00359762|Drug|glimepiride|oral tablet (titrated to maximally tolerated dose), once daily
16338536|NCT00359736|Drug|sildenafil|Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
16338537|NCT00359723|Drug|methylphenidate|
16338538|NCT00359697|Drug|Hypertonic Saline, Mannitol|
16338539|NCT00359671|Drug|MK6592|MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.
16338540|NCT00359671|Drug|comparator: docetaxel|docetaxel, delivered as a standard IV infusion.
16338541|NCT00359658|Drug|prednisolon|prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
16338542|NCT00359658|Drug|Mycophenolatmofetile|Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
16338543|NCT00359658|Drug|Cyclosporin A|Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml
16338544|NCT00359645|Procedure|Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years|
16338545|NCT00359632|Drug|Zyvox - linezolid|Observation and testing in patients for whom their treating physician has determined linezolid is an appropriate therapy. Eye tests performed for subjects who have received linezolid for at least 6 weeks and matching controls who have received other antibiotics for similar types of infections.
16338546|NCT00359632|Drug|Matched control|Matched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits.
16338547|NCT00359619|Biological|CervarixTM|Subjects were administered three doses of HPV vaccine
16338548|NCT00359619|Biological|HPV investigational vaccine GSK568893A, different formulations|Subjects were administered three doses of HPV investigational vaccine
16338549|NCT00359606|Drug|5-Fluoro-2-Deoxycytidine (FdCyd)|Given PO and IV
16338550|NCT00359606|Other|Laboratory Biomarker Analysis|Correlative Studies
16338551|NCT00359606|Other|Pharmacological Study|Correlative Studies
16338552|NCT00359606|Drug|Tetrahydrouridine (THU)|Given PO and IV
16338553|NCT00359593|Behavioral|Knowledge translation intervention package|
16338554|NCT00359567|Drug|palonosetron|intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
16338555|NCT00359567|Drug|granisetron hydrochloride|intravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
16338556|NCT00359554|Biological|VAXIGRIPPE|
16338557|NCT00359489|Device|cardiac echosonography|
16338558|NCT00359476|Drug|Vinflunine|solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
16338559|NCT00359463|Drug|eltrombopag|Subjects will be administered a single oral dose of 50 mg eltrombopag.
16338560|NCT00359450|Drug|BMS-275183 (oral taxane)|
16338561|NCT00359437|Drug|Satavaptan|oral administration once daily
16338562|NCT00359437|Drug|placebo|oral administration once daily
16338563|NCT00359424|Drug|IV rt-PA alone|Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.
16338651|NCT00358592|Device|traditional metal retraction instruments|
16338652|NCT00358579|Drug|Adrenaline|1 mg
16338564|NCT00359424|Other|endovascular therapy|Group two will receive a lower dose or the standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Endovascular therapy can be implemented with or without interarterial rt-PA use.
16338565|NCT00359398|Procedure|Platelet rich plasma sequestration|Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.
16338566|NCT00359385|Drug|Alendronate 70mg weekly|70mg weekly
16338567|NCT00359359|Drug|Sagopilone (BAY86-5302, ZK 219477)|Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
16338568|NCT00359359|Drug|Cisplatin|75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
16338569|NCT00359333|Drug|Gemcitabine , Docetaxel|Gemcitabine 800 mg/m2 IV over 80 minutes on day 1 and day 8, and Docetaxel 60 mg/m2 IV over 60 minutes on day 1 of a 21-day cycle
16338570|NCT00359320|Procedure|pancreaticojejunostomy|
16338571|NCT00359294|Drug|PM00104|Intravenously over 1 hour daily for 5 days, every 3 weeks.
16338572|NCT00359281|Drug|atorvastatin|Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg
16338573|NCT00359281|Drug|simvastatin|Simvastatin 20 mg and AEGR-733 10 mg or 60 mg
16338574|NCT00359281|Drug|ezetimibe|Ezetimibe 10 mg and AEGR-733 10 mg
16338575|NCT00359281|Drug|fenofibrate|Micronized Fenofibrate 145 mg and AEGR-733 10 mg
16338576|NCT00359281|Drug|dextromethorphan|Dextromethorphan 30 mg and AEGR-733 10 mg
16338577|NCT00359281|Drug|Extended Release Niacin|1000 mg ER niacin and AEGR-733 10 mg
16338578|NCT00359255|Behavioral|Education manual|The control arm was given education on stroke, the affected arm post strooke, bone health, and healthy living. This information was given in a booklet format and administered once weekly by the site coordinator.
16338579|NCT00359255|Behavioral|An inpatient homework based exercise program for the upper limb post stroke|"The experimental arm was given arm exercises graded based on motor impairment and administered by the site coordinator. The exercises were given in a booklet with written and photographic instructions. These exercises were monitored on a twice-weekly basis.
~The intervention was to be completed once daily for 45 minutes, 5 days per week, and supervised by the site coordinator. Exercises consisted of range of motion, strengthening, and use of the arm in daily activites such as buttoning, pouring and throwing."
16338580|NCT00359242|Behavioral|Infant Sleeping and Soothing|Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
16338581|NCT00359242|Behavioral|Repeated Food Exposure|Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
16338582|NCT00359229|Drug|Zolpidem|Administration of Zolpidem 5mg
16338583|NCT00359216|Drug|Mometasone furoate nasal spray|MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
16338584|NCT00359216|Drug|Placebo|Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
16338585|NCT00359203|Device|Dual chamber pacemeker|
16338586|NCT00359190|Drug|lapatinib|GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route
16338587|NCT00359177|Drug|GW679769|GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning
16338588|NCT00359164|Drug|Verteporfin Photodynamic Therapy (Low Fluence) and bevacizumab|"Bevacizumab 1.25 mg with verteporfin at Low Fluence (300 mW/cm2 delivered for 83 seconds [light dose of 25 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
16338589|NCT00359164|Drug|Verteporfin Photodynamic Therapy (Very Low Fluence) and bevacizumab|"Bevacizumab 1.25 mg with verteporfin at Low Fluence (150 mW/cm2 delivered for 83 seconds [light dose of 12.5 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
16338590|NCT00359164|Drug|Verteporfin Photodynamic Therapy (SHAM) and bevacizumab|"Bevacizumab with SHAM (150 mW/cm2 delivered for 83 seconds [light dose of 12.5 J/cm2]) Photodynamic Therapy.
~Treatment at Baseline visit, followed by an as needed basis. Assessments monthly for bevacizumab and at 3-month intervals for combination therapy with verteporfin or sham."
16338591|NCT00359151|Drug|Celecoxib|7 days pre-surgery (excluding day of surgery): 1 celecoxib 200 mg capsule or matching placebo QD; Day of surgery: 2 celecoxib 200 mg capsules or matching placebo within 2 hours prior to surgery, and 1 celecoxib 200 mg capsule or matching placebo following surgery; Post-surgery: starting the day after surgery, 1 celecoxib 200 mg capsule or matching placebo BID for the duration of the study.
16338592|NCT00359151|Drug|Placebo|Placebo once daily (QD) for 7 days pre-surgery (excluding the day of surgery); Placebo within 2 hours prior to surgery; and post surgery on the same day of the surgery; Placebo twice daily (BID) following the day of surgery and for the duration of the study.
16338593|NCT00359138|Drug|desloratadine|5 mg tablet once daily
16338594|NCT00359138|Drug|levocetirizine|5 mg capsule once daily
16338595|NCT00359138|Drug|Desloratadine placebo tablet|once daily
16338596|NCT00359138|Drug|Levocetirizine placebo capsule|once daily
16338597|NCT00359125|Drug|mifepristone (RU-486)|RU-486, 600 mg/day for 1 week.
16338598|NCT00359125|Other|Placebo|Placebo, 600 mg/day for 1 week.
16338599|NCT00359112|Drug|metformin|
16338600|NCT00359112|Drug|sulphonylurea|
16338601|NCT00359112|Drug|Avandamet|
16338602|NCT00359086|Drug|MGCD0103|MGCD0103 given orally three times per week
16338603|NCT00359073|Drug|montelukast|10 mg everyday
16338604|NCT00359073|Drug|placebo|like placebo
16338605|NCT00359060|Behavioral|Physical activity|
16338606|NCT00359047|Behavioral|Documentation|Participants will receive written educational material for themselves as well as the Guidelines document for their physician (same written material as in the Educational Video Group). They will be asked to revisit their physician and provide written documentation inviting him/her to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada
16338607|NCT00359047|Behavioral|Video|Participants will receive a 15-minute educational video on osteoporosis. They will also receive written educational material for themselves and a Guidelines document for their physician. They will be asked to revisit their physician and provide the written documentation inviting her/him to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. Should participants wish to obtain additional information on osteoporosis, they will be provided with a toll-free number (1-866-571-ROCQ) to contact
16338608|NCT00359021|Drug|TMC125|200 mg twice daily until commercially available
16338609|NCT00358995|Behavioral|Cognitive Behavioral Therapy|Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
16338610|NCT00358995|Behavioral|Stress Management Therapy (SMT)|Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
16338611|NCT00358982|Drug|MGCD0103|MGCD0103 administered orally three times per wek
16338612|NCT00358969|Drug|guanfacine (Tenex)|
16338613|NCT00358956|Drug|ZD6474 (vandetanib)|100 mg once daily oral tablet
16338614|NCT00358930|Drug|ARQ 501|
16338615|NCT00358917|Drug|lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg once-daily (QD) tablet
16338616|NCT00358917|Drug|lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg twice-daily (BID) tablet
16338617|NCT00358878|Drug|Satavaptan|oral administration once daily
16338618|NCT00358878|Drug|placebo|oral administration once daily
16338619|NCT00358852|Other|No intervention|This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.
16338620|NCT00358839|Drug|CGRP|
16338621|NCT00358826|Drug|VIA-2291|oral dosing, 1 time daily for 12 or 24 weeks
16338622|NCT00358826|Drug|Placebo|oral dosing, 1 time daily for 12 or 24 weeks
16338623|NCT00358813|Drug|Casopitant|Casopitant oral tablets will be available with a dose of 50 milligrams.
16338624|NCT00358800|Device|REMStar Auto with C-Flex|
16338625|NCT00358787|Procedure|Crossed K-wiring of supracondylar fracture of the humerus|Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
16338626|NCT00358787|Procedure|Lateral K-wiring of supracondylar fracture of the humerus|Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
16338627|NCT00358774|Procedure|homeopathic nasal spray|
16338628|NCT00358748|Drug|Hydrocortisone|See detailed description above.
16338629|NCT00358735|Device|ActiveCare CECT device|Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.
16338630|NCT00358735|Drug|Enoxaparin|Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.
16338631|NCT00358722|Drug|Fermagate|Film coated tablet 500mg
16338632|NCT00358709|Behavioral|Cognitive-Behavioral therapy and Symptom Management|A group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group.
16338633|NCT00358696|Drug|tenofovir|See Detailed Description.
16338634|NCT00358683|Drug|Certolizumab pegol|
16338635|NCT00358670|Biological|infliximab|"Infliximab maintenance therapy
~intravenous (IV) infusion every 8 weeks, 5 mg/kg body weight (first infusion at Week 4/Visit 2)."
16338636|NCT00358670|Biological|infliximab|"Infliximab intermittent therapy:
~Paricipants will receive no infliximab treatment until the Week 26 improvement in PASI from Baseline (original Study P04271 [NCT00251641] Baseline) is reduced by more than 50%. At that time, participants will receive an infliximab infusion, 5 mg/kg body weight. Participants may receive additional infusions at 0, 2, 6, and 14 weeks after the first infusion of the cycle (ie, a maximum of 4 infusions in each infusion cycle) as needed until they respond, defined as a >=75% improvement in PASI from the original Baseline in Study P04271. Subjects will receive no further treatment until they relapse again (ie, improvement in PASI from Baseline is reduced by more than 50%), at which time participants will receive another infusion cycle of up to 4 infusions, as described above. Throughout the study, intermittent treatment infusion cycles will be repeated whenever participants relapse."
16338637|NCT00358657|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplantation
16338638|NCT00358657|Drug|Cyclophosphamide|Given IV
16338639|NCT00358657|Drug|Fludarabine Phosphate|Given IV
16338640|NCT00358657|Other|Laboratory Biomarker Analysis|Correlative studies
16338641|NCT00358657|Drug|Mycophenolate Mofetil|Given PO
16338642|NCT00358657|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic bone marrow transplantation
16338643|NCT00358657|Drug|Sirolimus|Given PO
16338644|NCT00358657|Drug|Tacrolimus|Given IV or PO
16338645|NCT00358657|Radiation|Total-Body Irradiation|Undergo total-body irradiation
16338646|NCT00358644|Drug|Decitabine|20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
16338654|NCT00358566|Biological|GV1001|0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
16338655|NCT00358566|Drug|Gemcitabine (Chemotherapy)|Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
16338656|NCT00358553|Drug|Insulin|
16338657|NCT00358540|Drug|eltrombopag|Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
16338658|NCT00358527|Drug|Mometasone Furoate Nasal Spray (MFNS)|MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days.
16338659|NCT00358527|Other|Placebo|Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days
16338660|NCT00358514|Device|Continuous Compartment Pressure Monitoring|See Detailed Description.
16338661|NCT00358501|Drug|Defibrotide|Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
16338662|NCT00358488|Drug|GSK159797 (10, 15, and 20mcg)|GSK159797 (10, 15, and 20mcg)
16338663|NCT00358488|Drug|salbutamol|salbutamol
16338664|NCT00358488|Drug|salmeterol 50mcg|salmeterol 50mcg
16338665|NCT00358488|Drug|placebo|placebo
16338666|NCT00358475|Drug|GW685698|
16338667|NCT00358462|Drug|Azithromycin|two 500mg tablets or four 250mg tablets administered as a single dose
16338668|NCT00358462|Drug|Doxycycline|one 100mg capsule administered twice daily for seven days
16338669|NCT00358449|Drug|mepolizumab|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
16338670|NCT00358436|Drug|Aclidinium bromide|Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
16338671|NCT00358436|Drug|Placebo|Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
16338672|NCT00358423|Drug|Pegaptanib Sodium|0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
16338673|NCT00358423|Drug|Control|Sham injections, every 6 weeks, up to a total of 3 sham injections
16338674|NCT00358410|Drug|GW679769 oral tablets|2x GW679769 60mg tablets
16338675|NCT00358410|Drug|Placebo|Placebo oral tablets to match experimental intervention
16338676|NCT00358397|Drug|Clostridium novyi-NT spores|
16338677|NCT00358384|Drug|Pazopanib|Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
16338678|NCT00358384|Drug|Pazopanib vehicle|Pazopanib vehicle will be given to subjects.
16338679|NCT00358384|Drug|Betamethasone valerate|Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.
16338680|NCT00358384|Drug|Calcipotriol|Calcipotriol ointment with 0.005 percent concentration will be given to subjects.
16338681|NCT00358371|Drug|flucloxacillin 250 mg|Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
16338682|NCT00358371|Drug|flucloxacillin 500 mg|Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
16338683|NCT00358358|Drug|Fluticasone Propionate/Salmeterol 500/50mcg combination|
16338684|NCT00358358|Drug|Fluticasone Propionate 500mcg|
16338685|NCT00358358|Drug|Salmeterol 50mcg|
16338686|NCT00358332|Biological|FMP2.1/AS02A|FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection.
16338687|NCT00358332|Biological|Rabies vaccine (RabAvert)|RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine.
16338688|NCT00358319|Drug|Karenitecin|
16338689|NCT00358319|Drug|Valproic Acid|
16338690|NCT00358293|Drug|Tizanidine (sublingual or oral)|
16338691|NCT00358280|Drug|Ropivacaine|
16338692|NCT00358280|Drug|Bupivacaine|
16338693|NCT00358267|Procedure|Partial Resection of Inferior Turbinates (PRIT)|PRIT involves surgically removing a small piece off the turbinate, which also reduces its size.
16338694|NCT00358267|Procedure|Radiofrequency Ablation (RFA)|RFA involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.
16338695|NCT00358241|Procedure|Nerve block|
16338696|NCT00358228|Drug|Rimonabant|
16338697|NCT00358215|Drug|Darbepoetin alfa|Administered by subcutaneous injection
16338698|NCT00358215|Drug|Placebo|Placebo subcutaneous injection
16338699|NCT00358202|Drug|cefepime|cefepime hydrochloride 1gm IM q24h
16338700|NCT00358202|Drug|ceftriaxone|ceftriaxone 1 gm IM q24h
16338701|NCT00358189|Device|Deep Brain Stimulation|
16338702|NCT00358176|Drug|Risedronate (HMR4003)|
16338703|NCT00358163|Drug|PTK787/ZK 222584|Taken in tablet form daily
16338704|NCT00358163|Drug|paclitaxel|Given as a 3-hour infusion once every 21 days
16338705|NCT00358150|Drug|Eliglustat tartrate|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, then either eliglustat 50 mg BID (if Genz-99067[active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=]5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID(if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing same treatment through study completion (Year 9). Participant receiving 100 mg BID could be considered for further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
16338706|NCT00358137|Behavioral|Aerobic Conditioning Program|
16338707|NCT00358137|Behavioral|Strength Training Program|
16338708|NCT00358124|Drug|insulin glargine|
16338709|NCT00358124|Drug|rosiglitazone|
16338711|NCT00358111|Device|Luma Cervical Imaging System|Colposcopy using LUMA Cervical Imaging System
16338712|NCT00358085|Procedure|Endovascular Repair of Abdominal Aortic Aneurysm|
16338713|NCT00358085|Procedure|Conventional open repair of Abdominal Aortic Aneurysm|
16338714|NCT00358072|Behavioral|Postremission consolidation based on MRD status|Application of combination chemotherapy aimed to reduce MRD burden in unselected patients, followed by MRD-adjusted therapy that range from maintenance chemotherapy (MRD-negative patients) to allogeneic SCT (MRD-positive patients) or high-dose therapy with autologous blood stem cell support (MRD-positive patients without compatible donor for allogeneic SCT)
16338715|NCT00358059|Behavioral|Behavioral Family Systems Therapy for Diabetes|
16338716|NCT00358046|Drug|ILY101|
16338717|NCT00358033|Behavioral|Counseling|
16338718|NCT00358033|Behavioral|Interactive Education|
16338719|NCT00358033|Behavioral|Group Support|
16338720|NCT00358033|Procedure|Pharmacologic case management|Provided by clinical pharmacists
16338721|NCT00358020|Drug|THALIDOMIDE|
16338722|NCT00358020|Drug|BORTEZOMIB|
16338723|NCT00358007|Device|PTV Reduction|The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
16338724|NCT00357994|Drug|Levodopa carbidopa intestinal gel (LCIG)|infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour)
16338725|NCT00357994|Drug|Placebo gel|
16338726|NCT00357994|Drug|Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets|
16338727|NCT00357994|Drug|Placebo (PBO) oral capsules|
16338728|NCT00357994|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16338729|NCT00357994|Device|PEG tube|percutaneous endoscopic gastrostomy tube
16338730|NCT00357994|Device|J-tube|jejunal tube
16338731|NCT00357981|Drug|ORTHO EVRA, the contraceptive patch|
16338732|NCT00357968|Drug|Prasugrel|Administered orally
16338733|NCT00357968|Drug|Clopidogrel|Administered orally
16338734|NCT00357968|Drug|Placebo for Prasugrel|Administered orally
16338735|NCT00357968|Drug|Placebo for Clopidogrel|Administered orally
16338736|NCT00357955|Behavioral|Behavioral counseling and peer support|Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
16338737|NCT00357955|Behavioral|Interactive Education|interactive lectures with hands-on learning
16338738|NCT00357955|Behavioral|Role modeling|learning from peers with similar disease and problems
16338739|NCT00357955|Procedure|Pharmacologic case management|provided by clinical pharmacists following pre-established algorithms
16338740|NCT00357942|Drug|morphine solution for injection|morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
16338741|NCT00357942|Drug|Placebo|Placebo mouthwash
16338742|NCT00357942|Drug|morphine mouthwash|morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
16338743|NCT00357942|Drug|Placebo|Placebo solution for injection every 3 hour for 24 hours
16338744|NCT00357929|Procedure|Permissive hypercarbia|
16338745|NCT00357916|Drug|PEP005 Topical Gel (0.01% concentration)|
16338746|NCT00357903|Biological|Etanercept|Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).
16338747|NCT00357890|Device|Pump therapy (CSII)|CSII initiated within 1 month of dx
16338748|NCT00357890|Drug|Multiple daily injections (MDI) using insulin glargine + rapid acting analog|MDI as control
16338749|NCT00357877|Drug|10% w/v chlorhexidine acetate coating FDA IND #45466|Dental coating topically applied by dental professional supragingivally to the full dentition
16338750|NCT00357877|Other|Placebo|
16338751|NCT00357864|Drug|carbachol|
16338752|NCT00357851|Drug|Aprotinin|
16338753|NCT00357825|Drug|[S,S]-Reboxetine|
16338754|NCT00357799|Device|VeinViewer|Using the VeinViewer, IV attempts will be made
16338755|NCT00357786|Drug|Replagal agalsidase alfa|
16338756|NCT00357786|Drug|Replagal|
16338757|NCT00357773|Drug|Azithromycin (T1225)|
16338758|NCT00357760|Biological|VEGF Trap|Given IV
16338759|NCT00357747|Drug|AEG35156|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
16338760|NCT00357747|Drug|docetaxel|After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
16338761|NCT00357734|Drug|Gefitinib|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
16338762|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 200 mg, twice daily, 7 days.
16338763|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 300 mg, twice daily, 8 days.
16338764|NCT00357721|Drug|Atazanavir Sulphate|Capsules, Oral, 400 mg, twice daily, 9 days.
16338765|NCT00357708|Drug|decitabine|Given IV
16338766|NCT00357708|Drug|vorinostat|Given orally
16338767|NCT00357708|Other|laboratory biomarker analysis|Correlative studies
16338768|NCT00357708|Other|pharmacological study|Correlative studies
16338769|NCT00357682|Drug|Esomeprazole|20mg per day
16338770|NCT00357682|Drug|Esomeprazole|80mg per day
16338771|NCT00357682|Drug|Aspirin|300mg per day
16338772|NCT00357669|Drug|Brivaracetam 25 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 25 mg
~Route of Administration: Oral use"
16338773|NCT00357669|Drug|Brivaracetam 50 mg|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
16339084|NCT00355316|Other|Blood draw|
16338774|NCT00357669|Other|Placebo|"Active Substance: Placebo Pharmaceutical Form: Tablet
~Concentration: 25 mg and 50 mg
~Route of Administration: Oral use"
16338775|NCT00357656|Drug|Recombinant Protein-Free Factor VIII (rAHF-PFM)|"An initial loading dose will be administered intravenously over a period <= 5 minutes (maximum of infusion rate of 10 mL/minute) within 60 minutes prior to surgery dose in order to maintain a minimum target FVIII level of at least 80% of normal.
~CI will start prior to surgery as soon as the loading dose has been administered, at a rate calculated according to a formula provided by the sponsor.
~All study product must be administered with a syringe pump running at an infusion rate according to the dosing regimen, but always >= 0.4 mL/h."
16338776|NCT00357656|Drug|Recombinant Protein-Free Factor VIII (rAHF-PFM)|The treatment schedule for intermittent BI of rAHF-PFM will begin with the administration of the loading dose according to the dose recommendations provided by the sponsor. If required by the hemostatic challenge, additional boluses may be administered after a blood sample for FVIII determination has been drawn. All infusions of rAHF PFM will be given over a period <= 5 minutes (maximum infusion rate, 10 mL/min).
16338777|NCT00357643|Drug|Calcium 500 mg/day and vitamin D 700 IU/day|
16338778|NCT00357630|Drug|gemcitabine hydrochloride|
16338779|NCT00357630|Procedure|quality-of-life assessment|
16338780|NCT00357617|Drug|celecoxib|
16338781|NCT00357617|Genetic|microarray analysis|
16338782|NCT00357617|Genetic|protein expression analysis|
16338783|NCT00357617|Other|immunoenzyme technique|
16338784|NCT00357617|Other|immunohistochemistry staining method|
16338785|NCT00357617|Other|laboratory biomarker analysis|
16338786|NCT00357617|Procedure|biopsy|
16338787|NCT00357617|Procedure|conventional surgery|
16338788|NCT00357617|Procedure|neoadjuvant therapy|
16338789|NCT00357604|Drug|Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)|Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.
16338790|NCT00357604|Drug|Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days|Tablets + Capsules/Capsules, Oral, (25 mcg of EE + 0.18/0.215/0.25 mg of NGM) + 300/100 mg then 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 21 days.
16338791|NCT00357591|Device|Continuous Aortic Flow Augmentation|1.0-1.5 lpm augmented blood flow
16338792|NCT00357565|Biological|filgrastim|All patients will receive G-CSF 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted.
16338793|NCT00357565|Drug|busulfan|Administered 1.1 mg/kg if <12 kg intravenous (IV) every 6 hours (0.8 mg/kg if >12 kg IV every 6 hours on Days -8 through -5.
16338794|NCT00357565|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of >200 ng/mL. For children < 40 kg the initial dose will be 2.5 mg/kg intravenous (IV) over 2 hours every 8 hours.
16338795|NCT00357565|Drug|fludarabine phosphate|Administered 25 mg/m^2 intravenous (IV) over 60 minutes on Days -4 through -2.
16338796|NCT00357565|Drug|melphalan|Administered 60 mg/m^2 intravenous (IV) over 30 minutes on Days -4 through -2.
16338797|NCT00357565|Drug|mycophenolate mofetil|All patients will begin mycophenolate mofetil (MMF) on day -3. Patients <45 kilograms will receive MMF at the dose of 15 mg/kg/dose every 8 hours (max dose 1gm/dose) orally or intravenously (PO or IV).
16338798|NCT00357565|Procedure|umbilical cord blood transplantation|The product is infused via IV drip directly into the central line without a needle, pump or filter on Day 0.
16338799|NCT00357552|Drug|Emtricitabine/Tenofovir disoproxil fumarate|Once daily
16338800|NCT00357552|Drug|Lopinavir/Ritonavir|Twice daily
16338801|NCT00357539|Drug|Azithromycin (T1225)|
16338802|NCT00357526|Drug|OCPs|
16338803|NCT00357526|Device|vaginal ring|
16338804|NCT00357500|Drug|celecoxib|
16338805|NCT00357500|Drug|cyclophosphamide|
16338806|NCT00357500|Drug|etoposide|
16338807|NCT00357500|Drug|fenofibrate|
16338808|NCT00357500|Drug|thalidomide|
16338809|NCT00357487|Device|peroperative scintillating probe|
16338810|NCT00357487|Device|operative gamma camera|
16338811|NCT00357474|Procedure|Transarterial chemoembolization|lipiodol, adriamycin and/or mitomycin
16338812|NCT00357474|Procedure|Percutaneous ethanol injection therapy|99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
16338813|NCT00357461|Biological|gp100:209-217(210M) peptide vaccine|
16338814|NCT00357461|Biological|gp100:280-288(288V) peptide vaccine|
16338815|NCT00357461|Biological|incomplete Freund's adjuvant|
16338816|NCT00357461|Biological|ipilimumab|
16338817|NCT00357448|Biological|denileukin diftitox|Given IP at 3 dose levels: 5mcg/kg of ONTAK, 15mcg/kg of ONTAK, or 25mcg/kg of ONTAK
16338818|NCT00357448|Procedure|intraperitoneal administration|After completion of I.P. normal saline infusion, the I.P. catheter will be capped and patients will be turned/rotated for 1 hour to help facilitate I.P. bathing w/ONTAK; patients will be turned/rotated every 15 minutes in 4 different positions for a total of 1 hour
16338819|NCT00357448|Other|laboratory biomarker analysis|Correlative studies
16338820|NCT00357448|Other|enzyme-linked immunosorbent assay|Correlative studies
16338821|NCT00357448|Other|flow cytometry|Correlative studies
16338822|NCT00357422|Procedure|Operation|No drug needed
16338823|NCT00357422|Procedure|Percutaneous ethanol injection therapy|99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week
16338824|NCT00357396|Biological|graft versus host disease prophylaxis/therapy|
16338825|NCT00357396|Drug|busulfan|
16338826|NCT00357396|Drug|melphalan|
16338827|NCT00357396|Drug|thiotepa|
16338828|NCT00357396|Procedure|allogeneic bone marrow transplantation|
16338829|NCT00357396|Procedure|allogeneic hematopoietic stem cell transplantation|
16338830|NCT00357396|Procedure|peripheral blood stem cell transplantation|
16338831|NCT00357383|Drug|Azithromycin (T1225)|
16338832|NCT00357370|Drug|Dapagliflozin|Tablets, Oral, once daily, up to 12 weeks
16349047|NCT00274105|Drug|telmisartan|
16338833|NCT00357370|Drug|Placebo|Tablets, Oral, 0 mg, once daily, up to 12 weeks
16338834|NCT00357357|Drug|HF0220|comparison of different dosages of drug
16338835|NCT00357331|Drug|potassium citrate|20 meq by mouth in capsule form twice daily
16338836|NCT00357318|Drug|sunitinib malate|Given PO
16338837|NCT00357318|Biological|bevacizumab|Given IV
16338838|NCT00357318|Other|pharmacological study|Correlative studies
16338839|NCT00357318|Other|laboratory biomarker analysis|Correlative studies
16338840|NCT00357305|Drug|vorinostat|Given orally
16338841|NCT00357305|Drug|cytarabine|Given IV
16338842|NCT00357305|Drug|etoposide|Given IV
16338843|NCT00357305|Other|pharmacological study|Correlative studies
16338844|NCT00357305|Other|laboratory biomarker analysis|Correlative studies
16338845|NCT00357292|Drug|Azithromycin (T1225)|
16338846|NCT00357279|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.
16338847|NCT00357279|Drug|Placebo - 0.9% w/v sodium chloride solution|4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
16338848|NCT00357253|Drug|capecitabine|This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.
16338849|NCT00357253|Radiation|radiation therapy|Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.
16338850|NCT00357240|Drug|Atazanavir|Capsules, Oral, 400 mg, once daily, 6 days.
16338851|NCT00357240|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
16338852|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
16338853|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
16338854|NCT00357240|Drug|Atazanavir|Capsules, Oral, 400 mg, once daily, 6 days.
16338855|NCT00357240|Drug|Atazanavir/Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
16338856|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
16338857|NCT00357240|Drug|Atazanavir/Ritonavir+Omeprazole|Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
16338858|NCT00357214|Dietary Supplement|Potassium Bicarbonate|67.5 mmol/d given as three tablets after each meal, with a full glass of water
16338859|NCT00357214|Dietary Supplement|Sodium Bicarbonate|67.5 mmol/d given as three tablets after each meal, with a full glass of water
16338860|NCT00357214|Dietary Supplement|Potassium Chloride|67.5 mmol/d given as three tablets after each meal, with a full glass of water
16338861|NCT00357214|Dietary Supplement|placebo (microcrystalline cellulose)|Given as three tablets after each meal, with a full glass of water
16338862|NCT00357201|Drug|Food supplement (T1675)|
16338863|NCT00357188|Drug|Atazanavir Sulphate + Ritonavir|Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
16338864|NCT00357188|Drug|Atazanavir Sulphate + Ritonavir + Efavirenz|Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
16338865|NCT00357162|Drug|belinostat|Given IV
16338866|NCT00357149|Drug|Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy|
16338867|NCT00357149|Drug|Concomitant cisplatin, 5-FU and radiotherapy|
16338868|NCT00357136|Behavioral|password usage|
16338869|NCT00357123|Drug|Rosuvastatin|20 mg 10 days daily since abdominal sepsis diagnosis
16338870|NCT00357110|Drug|Fulvestrant|intramuscular injection
16338871|NCT00357110|Drug|Anastrozole|1 mg oral tablet
16338872|NCT00357097|Drug|Ropinirole|
16338873|NCT00357084|Drug|methotrexate|
16338874|NCT00357084|Drug|methylprednisolone|
16338875|NCT00357084|Drug|prednisone|
16338876|NCT00357045|Drug|Paroxetine|
16338877|NCT00357032|Drug|belinostat|Given IV
16338878|NCT00357032|Other|laboratory biomarker analysis|Correlative studies
16338879|NCT00357019|Drug|N-acetyl-aspartyl-glutamate (NAAXIA Sine)|
16338880|NCT00357006|Drug|Estradiol|100 mcg adjunctive transdermal estradiol
16338881|NCT00357006|Drug|Estradiol|200 mcg adjunctive transdermal estradiol
16338882|NCT00357006|Other|placebo|adjunctive transdermal placebo
16338883|NCT00356993|Drug|Nicotine Replacement Therapy|transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
16338884|NCT00356993|Behavioral|behavioural intervention|Smoking cessation counselling, relapse prevention strategies
16338885|NCT00356980|Biological|colloidal gold-bound tumor necrosis factor|
16338886|NCT00356980|Other|pharmacological study|
16338887|NCT00356967|Drug|dianicline|
16338888|NCT00356954|Drug|N-acetylcystein|
16338889|NCT00356954|Drug|ascorbic acid|
16338890|NCT00356941|Drug|docetaxel|60 mg/m2 on day 1 of each week during radiation therapy
16338891|NCT00356941|Drug|oxaliplatin|Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy
16338892|NCT00356941|Procedure|radiation therapy|2 Gy Days 1-5 each week, total dose of 70Gy
16338893|NCT00356928|Drug|Cyclophosphamide|50 mg/kg/day intravenously (IV) on Days -2 and -1.
16338894|NCT00356928|Biological|Donor T cells|"CD8-depleted T cells given IV on Day 0. Dose levels are as follows (all doses in cells/kg):
~Dose level 1: 1E5 CD4+ cells and less than 3.2E3 CD8+ cells Dose level 2: 1E6 CD4+ cells and less than 3.2E4 CD8+ cells Dose level 3: 1E7 CD4+ cells and less than 3.2E5 CD8+ cells Dose level 4: 5E7 CD4+ cells and less than 1.6E6 CD8+ cells"
16338895|NCT00356915|Drug|Itraconazole 100mg capsules|Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
16349048|NCT00274105|Drug|Placebo|
16338896|NCT00356915|Drug|Itraconazole 200mg tablets|Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
16338897|NCT00356915|Drug|Placebo tablets|Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.
16338898|NCT00356902|Procedure|titration of oxygen during resuscitation|
16338899|NCT00356889|Drug|erlotinib hydrochloride|Given orally, 150 mg, once daily.
16338900|NCT00356889|Biological|bevacizumab|Given IV, 5mg/kg on days 1 and 15 every cycle
16338901|NCT00356863|Behavioral|Increasing awareness to cardiac rehabilitation programs|Increasing awareness to cardiac rehabilitation programs: Before coronary artery bypass grafting (CABG) surgery patients received a face-to-face explanation on their right to participate in cardiac rehabilitation programs (CRPs) under the Israeli Basket of Health Services; they were also provided with a brochure on the benefits of CRP participation and the availability of CRPs throughout the country.
16338902|NCT00356850|Drug|Azithromycin|
16338903|NCT00356837|Procedure|Ultrasound|use ultrasound to confirm diagnosis of extremity fractures
16338904|NCT00356824|Drug|Amodiaquine|200 mg oral tablet taken daily for 3 days under direct supervision at study clinic
16338905|NCT00356824|Drug|Artesunate|50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
16338906|NCT00356811|Drug|Lapatinib oral tablets|Lapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
16338907|NCT00356811|Drug|Paclitaxel infusion|Subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.
16338908|NCT00356798|Biological|an inactivated whole virion H5N1 vaccine, adjuvanted|
16338909|NCT00356785|Behavioral|health education|
16338910|NCT00356785|Behavioral|food supplementation|
16338911|NCT00356785|Behavioral|food supplementation combined with physical activity program|
16338912|NCT00356772|Drug|Azithromycin|
16338913|NCT00356759|Drug|Dosing warfarin every 12 weeks, sham INRs 2 out of 3 times|Warfarin is dosed according to INR to maintain INR 2.0-3.0 or for mechanical mitral valves or mechanical aortic valves with atrial fibrillation INR 2.5-3.5
16338914|NCT00356733|Drug|Erythropoietin administration|50 IU/kg/week EPO to a target haemoglobin level of 13.7 g/dL for men and 13.4 g/dL for women (group A) or to a target comparable to starting hemoglobin level (group B)
16338915|NCT00356720|Drug|Azithromycin|
16338916|NCT00356681|Drug|AMG 706 placebo|Blinded placebo
16338917|NCT00356681|Drug|Bevacizumab|Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
16338918|NCT00356681|Drug|AMG 706|AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
16338919|NCT00356681|Drug|Paclitaxel|Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
16338920|NCT00356668|Device|High Flow Nasal Cannula|30 minute blocks on varying flows of high flow nasal cannula
16338921|NCT00356655|Behavioral|Psychoeducation|
16338922|NCT00356642|Drug|GW842470X|GW842470X will be available as a yellow smooth water-in-oil cream.
16338923|NCT00356642|Drug|Placebo|GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
16338924|NCT00356616|Drug|Trizivir (AZT+3HT+Abacavir) twice daily|Trizivir (AZT+3HT+Abacavir) twice daily
16338925|NCT00356616|Drug|Viread (300 mg Tenofovir disoproxil fumarate) once daily|Viread (300 mg Tenofovir disoproxil fumarate) once daily
16338926|NCT00356603|Drug|Sumatriptan Succinate|Sumatriptan Succinate
16338927|NCT00356590|Biological|Etanercept|Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
16338928|NCT00356564|Biological|hepatitis B vaccine|
16338929|NCT00356551|Behavioral|Family Spirit curriculum|
16338930|NCT00356525|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
16338931|NCT00356525|Drug|gemcitabine|1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
16338932|NCT00356525|Drug|carboplatin|area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
16338933|NCT00356525|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
16338934|NCT00356486|Drug|Peginterferon alfa-2a, Ribavirin, epoetin-β|Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks
16338935|NCT00356486|Drug|Peginterferon alfa-2a + Ribavirin for 12 weeks|Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
16338936|NCT00356473|Drug|Atorvastatin|
16338937|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 0.1 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.1 mg/kg IV (one dose every 14 days)
16338938|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 0.3 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.3 mg/kg IV (one dose every 14 days)
16338939|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 1.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 1.0 mg/kg IV (one dose every 14 days)
16338940|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 3.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 3.0 mg/kg IV (one dose every 14 days)
16350058|NCT00265551|Drug|placebo|
16338941|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 10.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 10.0 mg/kg IV (one dose every 14 days)
16338942|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
16338943|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ ) Monoclonal Antibody|1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days)
16338944|NCT00356460|Biological|GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody|1 dose of 15.0 or 10.0 mg/kg IV (based on safety profile of part 2, cohort 1) followed by a 28 day observation period and then 3 additional doses of 15.0 or 10.0 mg/kg IV (one dose every 14 days)
16338945|NCT00356447|Drug|Estradiol/DRSP (Angeliq, BAY86-4891)|Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.
16338946|NCT00356447|Drug|Placebo|Same administration.
16338947|NCT00356434|Device|Kendall A-V foot impulse pump, model 6060|Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
16338948|NCT00356434|Device|Kendall sequential compression device, model 9525|Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use
16338949|NCT00356421|Drug|Inhaled Human Insulin (Exubera®)|Preprandial inhaled insulin regimen and administration of insulin glargine QD
16338950|NCT00356421|Drug|Insulin lispro (Humalog)|Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
16338951|NCT00356408|Biological|Certolizumab pegol|"Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).
~Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2."
16338952|NCT00356395|Drug|ramipril, candesartan|
16338953|NCT00356382|Drug|Lactobacillus (L.) casei|
16338954|NCT00356369|Biological|meningococcal ACWY (vaccine)|One intramuscular dose.
16338955|NCT00356369|Biological|Mencevax™ ACWY|One subcutaneous dose.
16338956|NCT00356356|Drug|Etanercept|Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
16338957|NCT00356343|Device|NMES Strength Training|Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.
16338958|NCT00356343|Other|Volitional Strength Training|Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.
16338959|NCT00356317|Behavioral|Culturally informed therapy for schizophrenia (CIT-S)|This family therapy consists of 15 video-taped, therapy sessions, each lasting approximately 75 minutes. The 15-session treatment will be broken down into five segments (each lasting approximately three sessions) with the following goals: 1) Fortify a strong sense of family unity; 2) educate about schizophrenia; 3) foster adaptive use of cultural, spiritual and/or existential beliefs in conceptualizing and coming to terms with schizophrenia; 4) teach effective communication training techniques; and 5) and teach useful problem solving strategies.
16338960|NCT00356317|Behavioral|Psychoeducation treatment as usual|This family therapy consists of three weekly sessions focusing on education about schizophrenia.
16338961|NCT00356304|Behavioral|Motivational interviewing|Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.
16338962|NCT00356304|Behavioral|Treatment as usual|Participants will continue with their normal treatment regimen as usual.
16338963|NCT00356291|Behavioral|Skill-Building (SB) plus Motivational Interviewing|SB is a 4 to 5 session individually-based psychoeducational intervention. Participants meet weekly with an interventionist for 3 to 4 weeks and then receive a booster session 3 months after baseline. The traditional Skill-Building intervention will be augmented with Motivational Interviewing techniques.
16338964|NCT00356291|Behavioral|Skill-Building (SB)|SB is a 4-session individually-based psychoeducational HIV risk reduction intervention. Participants meet weekly with an interventionist for 3 weeks and then receive a booster session 3 months after baseline.
16338965|NCT00356278|Drug|D-Cycloserine|D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
16338966|NCT00356278|Drug|Alprazolam|Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
16338967|NCT00356278|Behavioral|Virtual Reality Exposure Therapy|VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
16338968|NCT00356278|Drug|Placebo|Placebo will be administered in the same manner as the active drugs.
16338969|NCT00356265|Drug|Procedure: Regional phenylephrine arterial infusion|
16338970|NCT00356252|Drug|mixed carotenoids|
16338971|NCT00356226|Drug|clonidine|
16338972|NCT00356213|Procedure|sleeve gastrectomy|laparoscopic sleeve gastrectomy
16338973|NCT00356213|Procedure|Roux-Y-gastric bypass|laparoscopic gastric bypass
16338974|NCT00356200|Drug|Fluphenazine Decanoate|"Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: APP Pharmaceuticals is the name of the pharmaceutical company; APP is not an acronym."
16338975|NCT00356200|Drug|Placebo|The sterile placebo (sesame oil with 1.2% (w/v) benzyl alcohol) was prepared at the University of Iowa, Division of Pharmaceutical Services, a FDA registered pharmaceutical manufacturing facility.
16338976|NCT00356187|Drug|Propranolol|
16338977|NCT00356161|Device|interventionally implanted hepatic arterial port catheter|
16338978|NCT00356148|Drug|Ampicillin/Sulbactam|Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
16338979|NCT00356135|Drug|prasugrel 10 mg|10 mg tablet taken orally
16338980|NCT00356135|Drug|clopidogrel|75 mg tablet taken orally
16338981|NCT00356135|Drug|prasugrel placebo|oral, as blinding mechanism.
16338982|NCT00356135|Drug|prasugrel 60 mg|60 mg (six 10-mg tablets) taken orally
16338983|NCT00356135|Drug|clopidogrel placebo|oral, as blinding mechanism
16338984|NCT00356122|Drug|Docetaxel|70 mg/m^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)
16338985|NCT00356122|Drug|Oxaliplatin|100 mg/m^2 administered IV on Day 1 for Cycles 1-6
16338986|NCT00356122|Drug|Bevacizumab|15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.
16338987|NCT00356109|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 6 months
16338988|NCT00356109|Drug|Injectable insulin|patient specific dose, injected, before meals, 6 months
16338989|NCT00356109|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 6 months
16338990|NCT00356096|Drug|pramipexole|
16338991|NCT00356083|Drug|Methadone|
16338992|NCT00356070|Drug|Strattera|
16338993|NCT00356057|Device|Protos DR/CLS and Stratos LV CRT pacemakers|Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption
16338994|NCT00356044|Procedure|Coronary angioplasty|
16338995|NCT00356031|Drug|Bevacizumab|Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
16338996|NCT00356031|Radiation|Radiation Therapy|External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
16338997|NCT00356031|Procedure|Surgery|Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
16338998|NCT00356018|Behavioral|Compliance|
16338999|NCT00356005|Drug|azithromycin plus artesunate|
16339000|NCT00356005|Drug|Artesunate|
16339001|NCT00355979|Device|intragastric balloon|
16339002|NCT00355966|Drug|Misoprostol|In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
16339003|NCT00355966|Drug|PGE2 gel|In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.
16339004|NCT00355953|Drug|Genistein|
16339005|NCT00355940|Device|Technological Methods|"Usage of technological methods and devices to improve intravascular navigation during endovascular aortic repair.
~In this arm we first use an optical pointer to allocate the femoral artery ramification (point of incision) and the lower renal artery (upper confinement of stent graft). Later we use an electromagnetically tracked catheter to find and enter the opening in the main stent graft before placing the second limb. For both optical and electromagnetic tracking we use a custom made navigation system based on 3 dimensional CT images"
16339006|NCT00355940|Device|Regular Fluoroscopy|Usage of conventional fluoroscopy and angiography for intravascular navigation. In this arm standard endovascular aortic repair is performed. The only means of navigation are fluoroscopy and angiography with overlay function (standard).
16339007|NCT00355927|Procedure|Sedation with IV propofol|Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved
16339008|NCT00355914|Procedure|Lumbar Facet Joint Nerve Block|Lumbar Facet Joint Nerve Block
16339009|NCT00355901|Drug|Visilizumab (Nuvion®; HuM291)|
16339010|NCT00355888|Drug|MBP-426|Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.
16339011|NCT00355875|Procedure|titration of oxygen during resuscitation|
16339012|NCT00355862|Drug|CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)|center specific therapeutic regimen without mTOR inhibition
16339013|NCT00355862|Drug|Sirolimus|Sirolimus based immunosuppression
16339014|NCT00355849|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 52 weeks
16339015|NCT00355849|Drug|Insulin Glargine|patient specific dose, injectable, before meals, 52 weeks
16339016|NCT00355836|Behavioral|Mental Imagery|
16339017|NCT00355810|Dietary Supplement|placebo followed by Lactobacillus plantarum MF 1298|placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
16339018|NCT00355810|Dietary Supplement|Lactobacillus plantarum MF1298 followed by placebo|Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
16339019|NCT00355797|Device|Closed Loop Stimulation (CLS)|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the Closed Loop Stimulation (DDD-CLS or VVI-CLS) pacing mode for the long-term follow-up portion of this study.
16339020|NCT00355797|Device|Standard Rate Adaptive (R) Technology|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the standard are adaptive pacing mode (DDDR or VVIR) for the long-term follow-up portion of this study.
16339021|NCT00355797|Device|Non-rate adaptive (DDD) pacing|Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the non-rate adaptive pacing mode (DDD or VVI) for the long-term follow-up portion of this study.
16339022|NCT00355784|Other|overfeeding|overfeeding 2000kcals/day above energy requirements for 14d
16339023|NCT00355784|Drug|growth hormone treatment|growth hormone administrated for 2 weeks (dose = 1.0 mg/m2/d)
16339024|NCT00355771|Drug|Levocetirizine|Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks
16339025|NCT00355771|Drug|Placebo|1 tablet OD in the morning for 8 weeks
16339026|NCT00355745|Device|Ultrasound breast scanning|breast scanning
16339027|NCT00355732|Procedure|Weaning from mechanical ventilation|
16339028|NCT00355719|Drug|Atazanavir (Reyataz)|Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)
16339029|NCT00355719|Drug|Ritonavir (Norvir)|Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)
16339030|NCT00355719|Drug|Nevirapine (Viramune)|Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)
16339031|NCT00355706|Procedure|Thoracic facet joint nerve blocks|Thoracic medial branch blocks
16339032|NCT00355693|Device|Pump for propofol delivery|
16339033|NCT00355680|Device|Green Laser (Aurolas, Aurolab)|Green laser developed by Aurolab
16339034|NCT00355680|Device|Green Laser (Iridex)|Already available green laser
16339035|NCT00355667|Drug|furosemide|Patients with chronic heart failure receive furosemide and other standard treatment/
16339036|NCT00355667|Drug|azosemide|Patients with chronic heart failure receive azosemide and other standard treatment.
16339037|NCT00355654|Biological|DT5aP-IPV-Hib 5-component Pertussis vaccine|0.5 mL, IM
16339038|NCT00355654|Biological|DT3aP-HBs-IPV|0.5 mL, IM
16339039|NCT00355641|Drug|Ropinirole Extended Release (XR)|Dose range of Ropinirole XR of 0.5mg to 6.0mg daily
16339040|NCT00355628|Drug|KW-2246 (fentanyl citrate)|KW-2246
16339041|NCT00355615|Drug|Rosuvastatin|oral
16339042|NCT00355615|Drug|Placebo|oral
16339043|NCT00355602|Drug|Cefuroxime|
16339044|NCT00355602|Drug|Ciprofloxacin|
16339045|NCT00355602|Drug|Clarithromycin|
16339046|NCT00355602|Drug|Cotrimoxazole|
16339047|NCT00355602|Drug|Coamoxiclav|
16339048|NCT00355602|Drug|metronidazole|
16339049|NCT00355602|Drug|neomycin|
16339050|NCT00355602|Drug|rifaximin|
16339051|NCT00355602|Drug|Vancomycin|
16339052|NCT00355602|Drug|Doxycycline|
16339053|NCT00355589|Drug|Ramipril and hydrochlorothiazide|
16339054|NCT00355576|Drug|Celecoxib|Celecoxib 400 mg BID with creatine 10 g BID if randomized to the Celecoxib + Creatine study arm.
16339055|NCT00355576|Drug|Creatine|10 g BID for either study arm
16339056|NCT00355576|Drug|Minocycline|Minocycline 100 mg BID with creatine 10 g BID if randomized to the Minocycline + Creatine study arm
16339057|NCT00355563|Device|PAS-Port Automated Proximal Anastomosis System|
16339058|NCT00355550|Drug|Tricaprilin|Powder formulation will be mixed in a liquid (approximately 8 oz).
16339059|NCT00355550|Other|Placebo|Powder formulation will be mixed in a liquid (approximately 8 oz).
16339060|NCT00355537|Drug|Testosterone|Sustanon- intramuscular testosterone 200mg every 2 weeks
16339061|NCT00355537|Drug|0.9% saline|Saline injection intramuscular every 2 weeks
16339062|NCT00355524|Drug|TMC114|TMC114 will be administered as oral tablets (75 milligram [mg] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks.
16339063|NCT00355524|Drug|Ritonavir|Ritonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks.
16339064|NCT00355511|Behavioral|education: disease, medication, self-care, diet|education on heart failure self care; medication initiation and titration, frequent follow-up
16339065|NCT00355485|Device|microdermabrasion|"Device: Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
~Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart."
16339066|NCT00355472|Drug|KW-0761|IV administration at 4 escalating dose levels.
16339067|NCT00355459|Drug|Tetracycline: Doxycycline analog|
16339068|NCT00355446|Drug|Bimatoprost 0.03%|
16339069|NCT00355433|Procedure|Urodymanics|
16339070|NCT00355407|Drug|Darbepoetin alfa|
16339071|NCT00355394|Drug|Metoclopramide|Intravenous bolus administration.
16339072|NCT00355394|Other|Placebo|Standard care including intravenous fluid, but no metoclopramide.
16339073|NCT00355381|Behavioral|Information Services (IRx)|Information services tailored to the needs of individual patients. The information prescription (IRx)or service is defined for this study as a combination of: 1)An evidence-based web site for use by patients and their families; 2) A reference interview and assistance in locating relevant general information in response to patient information needs; 3) Documentation of the questions and the information service provided in response to these in the patient's Electronic Patient Record for review by providers as needed; and, 4) Triage of patient's/parents clinical questions to providers.
16339074|NCT00355368|Drug|Succinylcholine|1mg/kg iv
16339075|NCT00355368|Drug|Rocuronium|0.6mg/kg iv
16339076|NCT00355355|Drug|Talaporfin sodium|LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.
16339077|NCT00355355|Device|Interstitial Light Emitting Diodes|200 J/cm per Light Source at 20 mW/cm light energy
16339078|NCT00355355|Procedure|Percutaneous placement of device in the liver|Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions.
16339079|NCT00355355|Procedure|Standard Care|The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.
16339080|NCT00355342|Drug|Salmeterol 50 mcg BID|Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
16339081|NCT00355342|Drug|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
16339082|NCT00355342|Device|DISKUS inhaler|Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
16339085|NCT00355303|Drug|Misoprostol|Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
16339086|NCT00355303|Drug|PGE2 gel|PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses
16339087|NCT00355290|Behavioral|Changes on Oral Vitamin K Intake|
16339088|NCT00355277|Drug|Amitriptyline|
16339089|NCT00355264|Drug|Phenoptin|5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels
16339090|NCT00355251|Drug|Atorvastatin 40 mg/Atorvastatin 80 mg|Atorvastatin 40 mg/80 mg
16339091|NCT00355238|Drug|brivanib (active)|Tablet, Oral, Brivanib 800 mg, once daily, until progression
16339092|NCT00355225|Procedure|ITN distribution channel|
16339093|NCT00355212|Procedure|percutaneous ablation of hepatocellular carcinoma|
16339094|NCT00355199|Drug|Rituximab-HDS|Rituximab-HDS
16339095|NCT00355199|Drug|Rituximab-CHOP|Rituximab-CHOP
16339096|NCT00355186|Procedure|intracoronary bone marrow cells infusion|"intracoronary bone marrow cell infusion via a OTW balloon; Stop-flow-technique as previously described"
16339097|NCT00355173|Device|Lubo cervical collar|
16339098|NCT00355147|Behavioral|Physician stroke guideline adherence|Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
16339099|NCT00355147|Behavioral|Stroke Self Management|Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA
16339100|NCT00355147|Other|Attention Control Group|Received Phone Calls from Staff to Control for Attention
16339101|NCT00355134|Drug|Fingolimod|Fingolimod capsules for oral administration
16339102|NCT00355134|Drug|Placebo|Matching placebo capsules for oral administration.
16339103|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
16339104|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
16339105|NCT00355121|Biological|Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
16339106|NCT00355108|Drug|tranexamic acid|2 3-month-periods in cross-over: placebo or 3g/day of tranexamic acid
16339107|NCT00355095|Drug|Erythropoietin|intravenous daily 3.3 *10^4 Units, duration 3 days
16339108|NCT00355082|Drug|lamotrigine, 300 mg/day|300 mg/day
16339109|NCT00355082|Drug|lamotrigine, 250 mg/day|250 mg/day
16339110|NCT00355069|Behavioral|electronic (computer based) provider feedback tool|All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
16339111|NCT00355056|Other|Sham Procedure|Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
16339112|NCT00355056|Device|AMPLATZER PFO Occluder|Patients in this arm will receive the AMPLATZER PFO Occluder device
16339113|NCT00355043|Drug|Zinc sulphate 20 mg|
16339114|NCT00355030|Drug|somatropin|0.05 mg/kg/day
16339115|NCT00355030|Drug|leuprorelin|11.25 mg/3 months
16339116|NCT00355017|Procedure|BNP-guided care in addition to multidisciplinary management|
16339117|NCT00355004|Other|counseling intervention|
16339118|NCT00355004|Procedure|fecal occult blood test|
16339119|NCT00355004|Procedure|screening colonoscopy|
16339120|NCT00354991|Drug|losartan potassium (+) hydrochlorothiazide|Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.
16339121|NCT00354978|Drug|5-Fluorouracil|"400 mg/m^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion.
~2.4 g/m^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m^2 injection."
16339122|NCT00354978|Drug|Bevacizumab|"5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs.
~5 mg/kg by vein on Day 1 of 14 day cycle."
16339123|NCT00354978|Drug|Leucovorin|400 mg/m^2 over 2-4 minutes by vein on Day 1 of 14 day cycle.
16339124|NCT00354978|Drug|Irinotecan|180 mg/m^2 by vein over 90 minutes on Day 1 of 14 day cycle.
16339125|NCT00354965|Drug|amoxicillin/clavulanate potassium|amoxicillin/clavulanate potassium
16339126|NCT00354952|Drug|Macrolides (azithromycin or clarithromycin)|
16339127|NCT00354939|Drug|Insulin glargine|
16339128|NCT00354926|Biological|AME-133v (LY2469298)|IV 4X weekly X 4
16339129|NCT00354913|Drug|hydroxyurea|Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydroxyurea at the same time that they take their prescribed imatinib mesylate, however, a 30-60 minute interval between agents is acceptable, if required for practical or other compliance issues.
16339130|NCT00354913|Drug|imatinib mesylate|"Imatinib administered orally on daily, continuous basis. Imatinib doses of 400mg/600mg administered once daily, whereas daily doses of 800mg/greater administered as equally divided dose taken twice day.
~Dose for Imatinib:
~Patients receiving p450-inducing antiepileptic drugs:500mg twice day Patients not receiving p450-inducing antiepileptic drugs:400mg/day.
~If patients who were not on Cytochrome P450, family 3, subfamily A (CYP3A) enzyme-reducing anti-epileptic drug (EIAED) when originally enrolled must initiate CYP3A enzyme-inducing anti-epileptic drug while on study, study regimen will remain same for minimum of 2 wks before pt transitions to dosing as specified for patients on anti-epileptic drug. If patients originally enrolled must discontinue all EIAEDs while on study, in interest of patient safety, dosing of study regimen will transition to that of patients not on anti-epileptics immediately."
16339131|NCT00354900|Drug|Aprotinin|
16339132|NCT00354887|Drug|Capecitabine|Oral capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m^2) on Days 1-14 in 21 Day Cycle.
16339133|NCT00354887|Drug|Oxaliplatin|130 mg/m^2 by vein Day 1 over 2 hours in 21 Day Cycle
16339134|NCT00354874|Drug|GW642444|drug
16339135|NCT00354874|Drug|Placebo|placebo
16339136|NCT00354874|Drug|salmeterol 50mcg|salmeterol
16339137|NCT00354861|Biological|hepatitis B antigen (without alum) plus IMP321|hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
16339138|NCT00354861|Biological|hepatitis B antigen alone (without alum)|hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
16339139|NCT00354861|Biological|Engerix B|20 µg hepatitis B antigen absorbed on alum
16339140|NCT00354835|Drug|Irinotecan Hydrochloride|Given IV
16339141|NCT00354835|Biological|Dactinomycin|Given IV
16339142|NCT00354835|Drug|Cyclophosphamide|Given IV
16339143|NCT00354835|Drug|Vincristine Sulfate|Given IV
16339144|NCT00354835|Radiation|Radiation Therapy|Undergo radiotherapy
16339145|NCT00354835|Other|Laboratory Biomarker Analysis|Correlative studies
16339146|NCT00354835|Other|Questionnaire Administration|Ancillary studies
16339147|NCT00354822|Drug|Zevalin|Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts>150x10^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.
16339148|NCT00354809|Drug|GW679769|
16339149|NCT00354770|Drug|Placebo|daily
16339150|NCT00354770|Drug|N-Acetyl Cysteine|600mg capsules in varying doses for 12 weeks.
16339151|NCT00354757|Drug|rabeprazole|
16339152|NCT00354744|Biological|dactinomycin|"Age based dosage: ≥ 1 year 0.045 mg/kg IV x 1(maximum dose 2.5 mg), < 1 year 0.025 mg/kg.
~Day 1 of Weeks 35, 38, 41 and 44.
~Given IV"
16339153|NCT00354744|Drug|cyclophosphamide|"Age based dosage: ≥ 3 years 1200 mg/m2, <3 years 40 mg/kg.
~Day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 and 44.
~Given IV"
16339154|NCT00354744|Drug|doxorubicin hydrochloride|"Age based dosage: ≥ 1 year: 37.5mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis. Total dose 75 mg/m².
~Days 1 and 2 of weeks 7, 11, 15, 28 and 32.
~Given IV"
16339155|NCT00354744|Drug|etoposide|"Age based dosage: ≥ 1 year: 100 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
~Days 1-5 of weeks 9, 13, 17, 26 and 30.
~Given IV"
16339156|NCT00354744|Drug|ifosfamide|"Age based dosage: ≥ 1 year: 1800 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
~Days 1-5 of weeks 9, 13, 17, 26 and 30.
~Given IV"
16339157|NCT00354744|Drug|irinotecan hydrochloride|"Dosage 50 mg/m2-max dose 100 mg/day.
~Days 1-5 of weeks 1, 4, 20, 23, 47 and 50.
~Given IV"
16339158|NCT00354744|Drug|vincristine sulfate|"Age based dosage: ≥ 3 years 1.5 mg/m2 (max dose 2 mg), ≥ 1 year and < 3 years 0.05 mg/kg (max dose 2 mg), < 1 year 0.025 mg/kg.
~Days 1-5 of weeks 1, 2, 3, 4, 5, 7, 8, 11, 12, 15, 16, 20, 21, 22, 23, 24, 28, 29, 32, 33, 35, 38, 41, 42, 43, 44, 47, 48, 50, and 51.
~Given IV"
16339159|NCT00354744|Procedure|conventional surgery|"Resection of the primary tumor with a surrounding envelope of normal tissue"
16339160|NCT00354744|Radiation|radiation therapy|Radiotherapy beginning at Week 20 to the primary tumor and to the metastatic sites excepting those with parameningeal tumors with intracranial extension (direct extension into the brain) and those requiring emergency radiotherapy
16339161|NCT00354744|Biological|filgrastim|"5 micrograms/kg/day (max 300 micrograms) beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/μL whichever comes last.
~Given subcutaneously."
16339162|NCT00354731|Drug|pentoxifylline|Oral pentoxifylline 1,200 mg/day (for estimated GFR ≧60 ml/min) or 800 mg/day (estimated GFR 59-30 ml/min) x 6 months, followed by stepwise reduction (800 mg/day x 6 M, 400 mg/day x 6 M and discontinued at 18 M
16339163|NCT00354731|Drug|Corticosteroid|Oral prednisolone (1 mg/kg/day) x 3 M, followed by gradual tapering (0.5 mg/kg/day at 6 M, 0.25 mg/day at 12 M, and discontinued at 18 M
16339164|NCT00354705|Behavioral|Questionnaire|Two questionnaires taking 30 minutes to complete.
16339165|NCT00354692|Drug|Sodium Ferric Gluconate and Iron sucrose|
16339166|NCT00354679|Biological|bevacizumab|
16339167|NCT00354679|Drug|cisplatin|
16339168|NCT00354679|Drug|irinotecan hydrochloride|
16339169|NCT00354679|Genetic|proteomic profiling|
16339170|NCT00354679|Other|diagnostic laboratory biomarker analysis|
16339171|NCT00354679|Other|mass spectrometry|
16339172|NCT00354679|Procedure|adjuvant therapy|
16339173|NCT00354679|Procedure|neoadjuvant therapy|
16339174|NCT00354679|Procedure|therapeutic conventional surgery|
16339175|NCT00354679|Radiation|radiation therapy|
16339176|NCT00354666|Drug|GSK159797|
16339177|NCT00354653|Drug|LAMIVUDINE|
16339178|NCT00354640|Drug|anastrozole|1 milligram tablet PO QD for 14 days
16339179|NCT00354640|Drug|simvastatin|40 milligram tablet PO QD for 14 days
16339180|NCT00354640|Other|pharmacological study|laboratory analysis
16339181|NCT00354640|Procedure|adjuvant therapy|laboratory analysis
16339182|NCT00354627|Drug|TMC125|200 mg b.i.d. till commercially available.
16339183|NCT00354614|Device|ApneaLink Sleep Screener|Device used to evaluate for the presence of OSA
16339184|NCT00354601|Drug|capecitabine|oral capecitabine twice daily on days 1-21
16339185|NCT00354601|Drug|docetaxel|docetaxel IV over 30 minutes on days 1, 8, and 15
16339186|NCT00354575|Drug|Chinese Herb: CCH1|1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
16339187|NCT00354562|Drug|ABT-751|200mg ABT-751 daily for 14 days every 21 days
16339188|NCT00354562|Drug|Placebo|Placebo daily for 14 days every 21 days
16339189|NCT00354562|Drug|Docetaxel|Standard Docetaxel every 21 days
16339190|NCT00354549|Drug|bevacizumab + erlotinib hydrochloride|Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
16339257|NCT00354198|Drug|corticosteroids|intravenous methylprednisolone (15 mg/kg/day or a maximum of 1 g/day) x 3 days + oral prednisolone (0.5-1.0 mg/kg/day) for 27 days] x 3 courses
16339191|NCT00354549|Drug|gemcitabine hydrochloride + cisplatin or carboplatin|Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16339192|NCT00354536|Drug|GSK716155 subcutaneous injections|albiglutide subcutaneous injection
16339193|NCT00354536|Biological|placebo injection|placebo injection
16339194|NCT00354523|Drug|Capecitabine (Xeloda)|Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle.
16339195|NCT00354523|Drug|DTIC-Dome (Dacarbazine)|Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle.
16339196|NCT00354523|Drug|Gleevec (Imatinib Mesylate)|Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
16339197|NCT00354510|Drug|GW842470X cream|
16339198|NCT00354497|Other|physiologic testing|
16339199|NCT00354497|Other|study of socioeconomic and demographic variables|
16339200|NCT00354497|Procedure|evaluation of cancer risk factors|
16339201|NCT00354497|Procedure|mutation carrier screening|
16339202|NCT00354497|Procedure|study of high risk factors|
16339203|NCT00354484|Drug|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
16339204|NCT00354484|Drug|Ferrous Sulfate tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
16339205|NCT00354471|Procedure|Uterine Artery Embolization|
16339206|NCT00354458|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
16339207|NCT00354458|Drug|Comparator: Placebo (unspecified)|rolofylline Pbo 30 mg IV QD; 3 days
16339208|NCT00354445|Drug|pegaptanib sodium (Macugen)|
16339209|NCT00354432|Dietary Supplement|oral soy protein/isoflavones powder|Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
16339210|NCT00354432|Drug|Venlafaxine|Patients receive oral venlafaxine 75mg.
16339211|NCT00354432|Dietary Supplement|Placebo Powder|Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
16339212|NCT00354432|Drug|Placebo Pill|Patients receive oral placebo pill.
16339213|NCT00354419|Radiation|total-body irradiation|Undergo radiotherapy
16339214|NCT00354419|Drug|cyclophosphamide|Given IV
16339215|NCT00354419|Biological|anti-thymocyte globulin|Given IV
16339216|NCT00354419|Drug|cyclosporine|Given IV
16339217|NCT00354419|Procedure|umbilical cord blood transplantation|Undergo transplantation
16339218|NCT00354419|Drug|mycophenolate mofetil|Given IV or orally
16339219|NCT00354419|Procedure|bone marrow aspiration|Correlative study
16339220|NCT00354419|Genetic|DNA analysis|Correlative study
16339221|NCT00354419|Biological|filgrastim|Given IV or SC
16339222|NCT00354406|Drug|abciximab|standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.
16339223|NCT00354393|Drug|cisplatin|
16339224|NCT00354393|Drug|methotrexate|
16339225|NCT00354393|Drug|vinorelbine ditartrate|
16339226|NCT00354393|Procedure|adjuvant therapy|
16339227|NCT00354393|Procedure|conventional surgery|
16339228|NCT00354393|Procedure|neoadjuvant therapy|
16339229|NCT00354393|Radiation|3-dimensional conformal radiation therapy|
16339230|NCT00354393|Radiation|intensity-modulated radiation therapy|
16339231|NCT00354380|Drug|Methylene blue|
16339232|NCT00354380|Drug|Artesunate|
16339233|NCT00354380|Drug|Amodiaquine|
16339234|NCT00354367|Drug|Certolizumab pegol|
16339235|NCT00354354|Drug|Combivent|Nebulized Combivent (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered once only to subjects.
16339236|NCT00354341|Drug|Epoetin beta|
16339237|NCT00354315|Behavioral|Continuous medical education (CME)|The intervention will be held over a 6 months period. DECISION+ is a multifaceted intervention program that includes: Interactive workshops (3x180 min), reminders of expected behaviours and feedback.
16339238|NCT00354302|Dietary Supplement|calcium carbonate|
16339239|NCT00354302|Dietary Supplement|calcium citrate|
16339240|NCT00354302|Dietary Supplement|cholecalciferol|
16339241|NCT00354302|Drug|alendronate sodium|
16339242|NCT00354302|Drug|calcium gluconate|
16339243|NCT00354302|Drug|risedronate sodium|
16339244|NCT00354302|Other|laboratory biomarker analysis|
16339245|NCT00354302|Procedure|dual x-ray absorptometry|
16339246|NCT00354276|Drug|cytarabine|
16339247|NCT00354276|Drug|laromustine|
16339248|NCT00354263|Biological|IMP321|This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.
16339249|NCT00354263|Biological|saline|saline injected alone in step 1 or mixed with Aggripal in step 2
16339250|NCT00354250|Drug|ispinesib|Given IV
16339251|NCT00354237|Other|Conventional antidiabetic treatment|No intensive treatment
16339252|NCT00354237|Other|Intensive insulin treatment|Intensive insulin treatment
16339253|NCT00354224|Drug|capecitabine|
16339254|NCT00354224|Drug|oxaliplatin|
16339255|NCT00354211|Device|minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device)|
16339256|NCT00354198|Drug|pentoxifylline|intravenous pentoxifylline (0.33-0.66 mg/kg/h from days 1 to 7) followed by oral pentoxifylline 400-800 mg/day (from days 8-90). The dose of intravenous pentoxifylline will be determined by estimated GFR, patients whose GFRs are 30-59 ml/min/1.73 m2 will be given 0.66 mg/kg/h, and those below 30 ml/min/1.73 m2 will be given 0.33 mg/kg/h. The oral dose of pentoxifylline will also be determined by estimated GFR. Patients whose estimated GFRs are between 30-59 ml/min/1.73 m2 will be given 800 mg/day, and those below 30 ml/min/1.73 m2 will be given 400 mg/day.
16351580|NCT00253487|Drug|temozolomide|
16339258|NCT00354185|Drug|tanespimycin|Given IV
16339259|NCT00354185|Drug|belinostat|Given IV
16339260|NCT00354185|Other|laboratory biomarker analysis|Correlative studies
16339261|NCT00354185|Other|pharmacological study|Correlative studies
16339262|NCT00354172|Biological|aldesleukin|10 Million units subcutaneous every other day on days -13 (after Natural killer cell graft), -11, -9, -7, -5, -3) If < 45 kilograms (Kg) - interleukin (IL)-2 at 5 MU/m2
16339263|NCT00354172|Biological|filgrastim|All patients will receive filgrastim (same as granulocyte-colony stimulating factor or G-CSF) 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight beginning on day +1 after umbilical cord blood (UCB) infusion. Granulocyte Colony Stimulating Factor (G-CSF) will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted.
16339264|NCT00354172|Biological|natural killer cell (NK) therapy|All CD3 depleted cells will be given (less those required for product monitoring). The minimum size of a starting NK cell unit will be 700 million mononuclear cells before processing. NK cells (CD56+) and NK cell precursors (CD34+/CD7-, CD34+/CD7+, CD34-/CD7+) will be monitored and reported but will not serve as lot release.
16339265|NCT00354172|Drug|cyclophosphamide|Cyclophosphamide to be administered with high volume fluid flush and mesna on days-18 and -17 after fludarabine. Cyclophosphamide 60 mg/kg/day intravenously (IV) x 2 days, total dose 120 mg/m2 (days -18 and -17)
16339266|NCT00354172|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -1 maintaining a level of >200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children <40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
16339267|NCT00354172|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -18 to -16)
16339268|NCT00354172|Drug|methylprednisolone|"This modification will be enacted based on the engraftment stopping rule on all subsequent patients to stop natural killer (NK) cell reaction.
~Methylprednisolone bolus 1000 mg intravenously (IV) will be administered day -1 and day 0 (before umbilical cord blood transplant) to suppress natural killer (NK) cell activity before transplant. Starting cyclosporin and mycophenolate mofetil (MMF) will also contribute to suppressing residual NK cell activity."
16339269|NCT00354172|Drug|mycophenolate mofetil|"All patients will begin mycophenolate mofetil (MMF) on day -1. Patients
~≥ 45 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses. Pediatric patient (<45 kilograms) will receive MMF at the dose of 15 mg/kg. Use intravenous (IV) route between days -1 and +5, then, if tolerated, may change to by mouth (PO) between days +6 and +30.
~Stop MMF at day +30 or 7 days after engraftment, whichever day is later, if no acute Graft Versus Host Disease. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9 /L)."
16339270|NCT00354172|Procedure|Umbilical Cord Blood Transplantation (UCBT)|The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
16339271|NCT00354172|Radiation|Total body irradiation (TBI)|"TBI 165 Gray (cGy) will be given twice daily for a total dose of 1320 cGy (days
~-16 to -13)."
16339272|NCT00354159|Device|Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)|Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
16339273|NCT00354146|Drug|tipifarnib (R115777)|
16339274|NCT00354133|Device|Kinetra and Soletra (neurostimulator, Medtronic)|Patients in this arm were implanted with a neurostimulator (Kinetra and Soletra from Medtronic) are stimulated. Additionally the get best medical treatment.
16339275|NCT00354133|Drug|Best Medical Treatment|Patients in this arm get best medical treatment only
16339276|NCT00354120|Drug|Alentuzumab|Alentuzumab
16339277|NCT00354120|Drug|Globulina antilinfocitaria|Globulina antilinfocitaria
16339278|NCT00354107|Biological|monoclonal antibody SGN-30|Given IV
16339279|NCT00354107|Drug|therapeutic hydrocortisone|Given IT
16339280|NCT00354107|Drug|ifosfamide|Given IV
16339281|NCT00354107|Drug|carboplatin|Given IV
16339282|NCT00354107|Drug|etoposide|Given IV
16339283|NCT00354107|Drug|methotrexate|Given IT
16339284|NCT00354107|Drug|cytarabine|Given IT
16339285|NCT00354107|Other|pharmacological study|Correlative studies
16339286|NCT00354107|Other|laboratory biomarker analysis|Correlative studies
16339287|NCT00354094|Drug|[S,S]-Reboxetine|
16339288|NCT00354081|Drug|folic acid, vitamin B12 (cyanocobalamin), vitamin B6 (pyridoxine)|folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg, in a capsule, taken orally once a day
16339289|NCT00354081|Drug|folic acid, vitamin B12 (cyanocobalamin)|folic acid 0.8 mg plus vitamin B12 0.4 mg, in a capsule, taken orally once a day
16339290|NCT00354081|Drug|vitamin B6 (pyridoxine)|vitamin B6 40 mg, in a capsule, taken orally once a day
16339291|NCT00354081|Drug|placebo|placebo, in a capsule, taken orally once a day
16339292|NCT00354068|Drug|imatinib mesylate|
16339293|NCT00354068|Drug|temozolomide|
16339294|NCT00354068|Other|pharmacological study|
16339295|NCT00354042|Drug|GW597901X|
16339296|NCT00354029|Drug|S (+) Ketamine|0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
16339297|NCT00354029|Drug|Placebo|isotonic saline
16339298|NCT00354016|Biological|preservative free inactivated split influenza vaccine using the strain composition 2006/2007|
16339299|NCT00354003|Behavioral|A series of questionnaires|Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.
16339300|NCT00353990|Drug|Insulin Aspart|
16339418|NCT00352976|Drug|Cyclophosphamide|Day -5 through Day -2, subjects will receive chemotherapy of Cyclophosphamide via central line (i.e. Hickman or Broviac),10 mg/kg intravenously (IV)
16351630|NCT00253240|Procedure|Screening|
16339301|NCT00353977|Biological|ALVAC-CMV (vCP260)|"ALVAC-pp65 (vCP260), an attenuated canary pox-based vaccine (Aventis Sanofi Pasteur, Lyon, France), 3 doses (1.0 ml each) delivered intramuscularly in the deltoid muscle.
~Sero-negative subjects will receive a total of 3 immunizations to be given day 0, 5 and 10.
~Sero-positive subjects will receive a total of 2 immunizations to be given day 0 and 5. (Protocol amendment after findings from the 9/6/2006 interim analysis demonstrated that in the sero-positive group, only 2 vaccinations were required to generate maximum immune response.)"
16339302|NCT00353964|Drug|rEV131|
16339303|NCT00353964|Drug|Prenisolone sodium phosphate 1.0%|
16339304|NCT00353964|Drug|rEV131 vehicle|
16339305|NCT00353938|Drug|3,4-methylenedioxymethamphetamine (125 mg)|Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
16339306|NCT00353938|Drug|3,4-methyelendioxymethamphetamine (25 mg)|Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
16339307|NCT00353938|Behavioral|Therapy|Non-directive therapy performed by a team of two co-therapists
16339308|NCT00353912|Drug|valsartan + amlodipine|
16339309|NCT00353886|Procedure|TONI-3|
16339310|NCT00353886|Procedure|WRAT-3|
16339311|NCT00353886|Procedure|Connor's Rating Scales PRS & TRS|
16339312|NCT00353886|Procedure|Peabody Picture Vocabulary Test|
16339313|NCT00353886|Procedure|Children's Memory Scale|
16339314|NCT00353886|Procedure|WISC-3|
16339315|NCT00353886|Procedure|Behavioral Assessment System for Children PRS & TRS|
16339316|NCT00353873|Drug|Fluticasone propionate|200μg twice daily
16339317|NCT00353873|Drug|Fluticasone propionate/salmeterol|50/100μg twice daily
16339318|NCT00353860|Device|SOLEX 300i Stem Cell Selection|
16339319|NCT00353847|Device|Acupuncture|
16339320|NCT00353834|Drug|Exenatide|Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks
16339321|NCT00353834|Drug|Glargine Insulin|Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.
16339322|NCT00353808|Drug|[S,S]-Reboxetine|
16339323|NCT00353795|Procedure|MR Imaging of the Coronary Arteries|
16339324|NCT00353769|Procedure|Hair Apposition Technique|
16339325|NCT00353756|Drug|C326, IL-6 Inhibitory Avimer protein|
16339326|NCT00353743|Drug|placebo|placebo
16339327|NCT00353743|Drug|doxycycline plus metronidazole|doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment)
16339328|NCT00353717|Drug|cetuximab paclitaxel|weekly iv paclitaxel 80 mg/m2 and cetuximab 250 mg /m2
16339329|NCT00353704|Drug|pregabalin|capsule 150 mg x 1 per orally one hour before surgery
16339330|NCT00353704|Drug|Placebo|One capsule of saccharose (placebo) was administered about one hour before surgery
16339331|NCT00353704|Drug|morphine|All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
16339332|NCT00353691|Drug|glimepiride|
16339333|NCT00353691|Drug|metformin|
16339334|NCT00353678|Drug|YM150|
16339335|NCT00353665|Drug|Memantine (Ebixa)|10 mg bid
16339336|NCT00353665|Drug|riluzole|riluzole 50 mg bid
16339337|NCT00353665|Drug|Placebo|
16339338|NCT00353652|Drug|Study#1: chlorthalidone (CTD), titrated dose|Participants in study #1 will receive 3 months of chlorthalidone (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg
16339339|NCT00353652|Drug|Study #1: spironolactone (SP), titrated dose|Participants in study #1 will receive 3 months spironolactone (25-75 mg/d), at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg.
16339340|NCT00353652|Drug|Study# 2 chlorthalidone (CTD), fixed dose|Participants in study #2 will receive 3 months of fixed-dose of CTD, at 25 mg/d.
16339341|NCT00353652|Drug|Study# 2 spironolactone (SP), fixed dose|Participants in study #2 will receive 3 months of fixed-dose SP at 25 mg daily.
16339342|NCT00353652|Drug|Study# 2 irbsesartan (IR), fixed dose|Participants in study #2 will receive 3 months of fixed-dose IR at150 mg daily.
16339343|NCT00353613|Behavioral|Package of targeted interventions to reduce error|Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.
16339344|NCT00353587|Drug|MBX-102|MBX-102 200 mg once daily for 16 weeks
16339345|NCT00353587|Drug|MBX-102|MBX-102 400 mg once daily for 16 weeks
16339346|NCT00353587|Drug|MBX-102|MBX-102 600 mg once daily for 16 weeks
16339347|NCT00353587|Drug|Placebo|MBX-102 Placebo once daily for 16 weeks
16339348|NCT00353587|Drug|Actos|Actos 30 mg once daily for 16 weeks
16339349|NCT00353574|Drug|Darusentan|Darusentan capsules administered orally once daily
16339350|NCT00353561|Drug|Boric|Gelatin capsules filled with 600 mg of boric acid
16339351|NCT00353561|Drug|Fluconazole|150 mg oral fluconazole gives once in 14 days
16339352|NCT00353535|Procedure|Total Lymphoid irradiation|
16339353|NCT00353522|Drug|Placebo|po daily for 24 weeks
16339354|NCT00353522|Drug|dalcetrapib|900mg po daily for 24 weeks
16339355|NCT00353509|Device|Device Closure of a Septal Defect|
16339356|NCT00353496|Drug|lanreotide (Autogel formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
16339357|NCT00353496|Drug|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
16339358|NCT00353483|Procedure|Peripheral blood draw|
16339359|NCT00353483|Procedure|Breast tissue collection|
16339360|NCT00353483|Procedure|Bone marrow biopsy|
16339361|NCT00353470|Behavioral|Cognitive behavioral therapy|CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
16339362|NCT00353470|Behavioral|Applied relaxation training (ART)|ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
16339363|NCT00353470|Behavioral|Panic focused psychodynamic psychotherapy (PFPP)|PFPP will include 19 to 24 sessions over 12 weeks.
16339473|NCT00352534|Procedure|therapeutic conventional surgery|Undergo surgery
16339364|NCT00353457|Drug|Capecitabine, Oxaliplatin and Cetuximab|Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8
16339365|NCT00353457|Radiation|Radiation|45 Gy in 25 fractions, 3-fraction boost 5.4 Gy
16339366|NCT00353431|Drug|Novorapid ®, Novo Nordisk, Denmark|Comparison of a sliding scale with an intensive s.c. scale
16339367|NCT00353418|Drug|Peginterferon alfa-2a|180 µg subcutaneously weekly for 48 weeks
16339368|NCT00353418|Drug|Ribavirin|800 mg orally daily for 48 weeks
16339369|NCT00353418|Drug|Ribavirin|1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
16339370|NCT00353405|Behavioral|Social Skills Training|Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.
16339371|NCT00353405|Behavioral|Mass media|Mass media provides messages that support sexual health skills.
16339372|NCT00353405|Behavioral|Control|Control group received no social skills training and no media mass media messages.
16339373|NCT00353392|Device|Laser Therapy|
16339374|NCT00353379|Drug|Guanfacine|Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
16339375|NCT00353379|Drug|Placebo|Participants will take placebo for 6 weeks.
16339376|NCT00353366|Biological|Rotarix|Two doses of the oral vaccine
16339377|NCT00353366|Other|Data collection|Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.
16339378|NCT00353353|Procedure|consumption of fortified bread|
16339379|NCT00353340|Drug|n acetylcysteine|
16339380|NCT00353340|Drug|sodium bicarbonate|
16339381|NCT00353340|Drug|sodium chloride|
16339382|NCT00353327|Procedure|Plasma infusion|
16339383|NCT00353301|Drug|Erlotinib hydrochloride|Patients will receive single-agent Tarceva, 150 mg/day
16339384|NCT00353301|Drug|Sirolimus|Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.
16339385|NCT00353288|Biological|MeMuRu-OKA (study vacc)|
16339386|NCT00353288|Biological|MMR, Varicella vacc (control)|
16339387|NCT00353275|Drug|Strict Glycemic control|Blood glucose target range is 80-110 mg/dL.
16339388|NCT00353275|Drug|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
16339389|NCT00353262|Drug|Avastin|7.5mg/kg iv (cycle 3 only)
16339390|NCT00353262|Drug|Oxaliplatin|130mg/m2 iv (cycles 1, 2 and 3)
16339391|NCT00353262|Drug|capecitabine [Xeloda]|1000mg/m2 po bid (cycles 1, 2 and 3)
16339392|NCT00353249|Behavioral|Adapted cognitive behavioral therapy (CBT)|Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks. The sessions will last 90-minutes and will be led by a therapist and co-therapist.
16339393|NCT00353223|Behavioral|Interpersonal and behavioral psychotherapy|Participants will receive a combined intervention of interpersonal and behavioral psychotherapy designed for people with heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours. The psychotherapy sessions will allow participants to discuss how they are coping with their illness and loss of functioning. They will also aim to help participants with heart failure to develop new recreational activities in keeping with their new level of functioning.
16339394|NCT00353223|Behavioral|Attention control (AC) condition|The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours.
16339395|NCT00353184|Drug|Montelukast 5-mg orally added to standard therapy|
16339396|NCT00353158|Drug|Doxycycline|100mg twice daily for 3 days. Two hours after the last dose of doxycycline is taken in the clinic, on-medication phototesting with ssUVR, UVA, and visible light will be performed.
16339397|NCT00353158|Drug|Voriconazole|After taking voriconazole for (Bullet)7 days to achieve a steady state of voriconazole for subjects, on-medication phototesting with ssUVR, UVA, and visible light will be performed.
16339398|NCT00353145|Drug|Gemcitabine (Gemox)|1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle).
16339399|NCT00353145|Drug|Oxaliplatin|100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
16339400|NCT00353145|Behavioral|Questionnaire|Quality of Life Surveys
16339401|NCT00353119|Drug|Placebo comparator|Patients received placebo subcutaneously twice weekly
16339402|NCT00353119|Drug|Etanercept|Patients received etanercept 50 mg subcutaneously twice weekly
16339403|NCT00353106|Behavioral|Interview|30-minute interviews of participating patients and their caregiver(s).
16339404|NCT00353106|Behavioral|Questionnaire|Questionnaires that will take approximately 5 minutes to complete.
16339405|NCT00353093|Procedure|Ultrasonography of the deep vein system of the legs|
16339406|NCT00353080|Drug|risedronate (HMR4003)|
16339407|NCT00353067|Drug|veliflapon (DG-031)|
16339408|NCT00353054|Drug|Caltrate® 600 + D|
16339409|NCT00353054|Behavioral|Weight loss intervention|
16339410|NCT00353041|Drug|lidocaine topical|
16339411|NCT00353028|Drug|Fluvoxamine maleate|Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
16339412|NCT00353028|Drug|Placebo|Placebo
16339413|NCT00353015|Drug|Cisplatin|Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle
16339414|NCT00353015|Drug|Irinotecan|Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle
16339415|NCT00353002|Drug|Ametop (4% Amethocaine cream )|
16339416|NCT00353002|Drug|Maxilene (4% Liposomal Lidocaine)|
16339417|NCT00352989|Drug|Smecta (Diosmectite), duration of treatment - 7 days|
16339474|NCT00352534|Drug|vincristine sulfate|Given IV
16339419|NCT00352976|Drug|Fludarabine|Day -5 through Day -2 prior to transplant; subjects will receive chemotherapy of Fludarabine via central line (i.e. Hickman or Broviac),35 mg/m^2 intravenous (IV)
16339420|NCT00352976|Procedure|Total Body Irradiation|total body irradiation (300 cGy) with thymic shielding will be given six days before the stem cells are given (day -6). Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus.
16339421|NCT00352976|Procedure|Bone Marrow Transplantation|A target of 5 * 10^6/kg and a minimum of 4 * 10^6 CD34+ cell/kg recipient weight will be collected by apheresis and used for transplant. In most cases this dose will be recovered in a single apheresis; however, a second or rarely third apheresis performed on the following days may be required to achieve the minimum dose.
16339422|NCT00352976|Drug|Mycophenolate Mofetil|Patients will receive MMF therapy beginning on day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 * 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours by mouth(to a maximum dose of 1 gram).
16339423|NCT00352976|Drug|Sirolimus|Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC). Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
16339424|NCT00352963|Biological|Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec|
16339425|NCT00352950|Drug|AMG 954/Panitumumab|
16339426|NCT00352911|Drug|VGX-410 (Mifepristone)|
16339427|NCT00352911|Drug|Placebo for VGX-410 (Mifepristone)|
16339428|NCT00352898|Biological|MeMuRu-OKA (study vac)|
16339429|NCT00352898|Biological|MMR, Varicella vacc (control)|
16339430|NCT00352885|Drug|Escitalopram|Participants will begin medication approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 10 mg per day. If 10 mg is well tolerated by the participant, the dosage will be increased to 20 mg per day. The dosage for the remainder of the study will be 20 mg per day.
16339431|NCT00352885|Drug|Placebo|Participants will begin the placebo approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 1 pill per day, if 1 pill is well tolerated by the participant the dosage will be increased to 2 pills per day. Two pills per day will be the dosage for the reminder of the study.
16339432|NCT00352885|Drug|IL-2|IL-2 is a 12-week treatment regimen with intravenous (IV) IL-2. There will be one cycle every 3 weeks for a total of four cycles. One cycle is 720,000 units/kg every 8 hours for 5 days.
16339433|NCT00352859|Drug|Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon|Continue sorafenib with addition of gemcitabine or interferon
16339434|NCT00352859|Drug|Gemcitabine or Interferon (only)|Discontinue Sorafenib and receive Gemcitabine or Interferon only
16339435|NCT00352846|Drug|Zoledronic Acid|4 mg/m^2 by vein over 30 Minutes at baseline and 6 months.
16339436|NCT00352846|Drug|Vitamin D|400 mg by mouth daily
16339437|NCT00352846|Drug|Calcium Carbonate|1200 mg by mouth daily
16339438|NCT00352833|Drug|catumaxomab|
16339439|NCT00352820|Behavioral|Interview|Recorded face-to-face session.
16339440|NCT00352820|Behavioral|Questionnaire|Written survey lasting approximately 30 minutes.
16339441|NCT00352807|Drug|Brimonidine Purite|
16339442|NCT00352794|Drug|Lenalidomide|Oral 10 mg daily/days 1-21 of 28 day cycle
16339443|NCT00352794|Drug|Prednisone|Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
16339444|NCT00352781|Drug|nicotine replacement therapy|nicotine transdermal patches as per product monograph
16339445|NCT00352781|Behavioral|behavioural intervention|Smoking cessation counselling and relapse prevention
16339446|NCT00352768|Drug|Fluvoxamine maleate|Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
16339447|NCT00352768|Drug|Placebo|Placebo
16339448|NCT00352755|Procedure|Surgical debulking with peritonectomy|
16339449|NCT00352755|Drug|Intraperitoneal 5FU|
16339450|NCT00352755|Drug|FOLFOX|
16339451|NCT00352742|Drug|ATN-224 + bortezomib|ATN-224 and bortezomib dose to be determined in Phase I portion of study
16339452|NCT00352729|Device|ACell dressing|dressing
16339453|NCT00352716|Drug|Smecta (Diosmectite), duration of treatment - 7 days|
16339454|NCT00352703|Drug|Kepivance (Palifermin)|
16339455|NCT00352690|Drug|Paclitaxel poliglumex|
16339456|NCT00352690|Drug|Carboplatin|
16339457|NCT00352690|Radiation|External beam radiation therapy|
16339458|NCT00352677|Drug|INNO-406|Oral, twice daily self-administration of 10 mg and/or 50 mg tablets
16339459|NCT00352664|Drug|Donepezil|5 mg once a day by mouth for 7 day cycle. After evaluation on Day 8, all participants will be offered donepezil every day for 7 days.
16339460|NCT00352664|Drug|Placebo|Placebo tablet once a day by mouth for one 7 day cycle. After evaluation on day 8, all participants offered donepezil every day for 7 days.
16339461|NCT00352651|Drug|Pregabalin|
16339462|NCT00352638|Other|counseling intervention|
16339463|NCT00352638|Other|educational intervention|
16339464|NCT00352638|Other|study of socioeconomic and demographic variables|
16339465|NCT00352625|Drug|Ketoprofen Topical Patch 20%|
16339466|NCT00352612|Drug|clindamycin|clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
16339467|NCT00352612|Drug|cephalexin|cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
16339468|NCT00352599|Drug|Lovastatin|
16339469|NCT00352599|Drug|Lovastatin|Lovastatin capsules daily for 14 weeks (titrated up from 10 mg to 40 mg)
16339470|NCT00352599|Drug|placebo pill|
16339471|NCT00352560|Drug|Irbesartan|Tablets, Oral, 300 mg, once daily, 30 days.
16339472|NCT00352560|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 30 days.
16339475|NCT00352534|Biological|dactinomycin|Given IV
16339476|NCT00352534|Drug|doxorubicin hydrochloride|Given IV
16339477|NCT00352534|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
16339478|NCT00352521|Drug|bevacizumab|
16339479|NCT00352521|Drug|irinotecan|
16339480|NCT00352521|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16339481|NCT00352508|Behavioral|Dietary advice|
16339482|NCT00352495|Drug|carboplatin|
16339483|NCT00352495|Drug|vinblastine sulfate|
16339484|NCT00352482|Drug|Sildenafil (50 mg)|
16339485|NCT00352469|Drug|Seroquel XR|Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
16339486|NCT00352443|Drug|everolimus|part 1: dose assigned by ETx online system PO days 1-28 daily part 2: cohort a: 5 mg PO days 1-28 part 2: cohort a: 1250 mg PO days 8-28 (cycle 1) days 1-28 (subsequent cycles)
16339487|NCT00352443|Drug|lapatinib ditosylate|dose assigned by ETx online system PO days 1-28 daily part 2 cohort a: 1250 mg PO d 8-28 (cycle 1) days 1-28 (subsequent cycles) part 2 cohort b: 120 mg PO days 1-28 daily
16339488|NCT00352430|Drug|Nitric Oxide/INP Pulse Delivery|
16339489|NCT00352430|Drug|Nitric Oxide/INO Pulse Delivery|
16339490|NCT00352417|Drug|VIA-2291|100 mg, oral dosing, 1 time daily for 12 weeks
16339491|NCT00352417|Drug|Placebo|oral dosing, 1 time daily for 12 weeks
16339492|NCT00352404|Device|Endomicroscope|
16339493|NCT00352391|Other|Assessments|At Months 6, 12, 18, 24, 30, and 36, complete medical history will be recorded, and a physical exam will be performed by either a doctor or a nurse. At each of these visits, blood will be drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Also, a chest x-ray and a chest CT will be done at these visits.
16339494|NCT00352378|Drug|Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine|"Patients will be randomized to receive regimen A (AC) and regimen B(TX),preoperatively as follows:
~Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14"
16339495|NCT00352365|Drug|lenalidomide|Given orally
16339496|NCT00352352|Procedure|Tongue Acupuncture (Procedure)|
16339497|NCT00352339|Drug|Rispridoen and Aripiprazole|Start with risperidone and switch it to aripiprazole. Flexible dose
16339498|NCT00352339|Drug|Risperidne|Start with risperidne and keep it through the end of study. Risperidne:flexible dose
16339499|NCT00352339|Drug|Abilify|Start with abilify and keep it through the end of study
16339500|NCT00352326|Device|reprogramming assisted communication device interface|The subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next.
16339501|NCT00352313|Drug|ATN-161|Given IV
16339502|NCT00352313|Drug|carboplatin|Given IV
16339503|NCT00352300|Procedure|Adjuvant Therapy|
16339504|NCT00352300|Drug|Carboplatin|Given IV
16339505|NCT00352300|Drug|Paclitaxel|Given IV
16339506|NCT00352300|Biological|Pegfilgrastim|Given IV
16339507|NCT00352287|Drug|Recombinant human growth hormone; pioglitazone|
16339508|NCT00352261|Drug|Esomeprazole|
16339509|NCT00352261|Drug|Lansoprazole|
16339510|NCT00352248|Procedure|Tongue Acupuncture (Procedure)|
16339511|NCT00352235|Drug|KRN7000|
16339512|NCT00352222|Device|stent implantation|
16339513|NCT00352196|Drug|Risperidone|12 weeks of treatment with risperidone 0.25 to 11 mg per day.
16339514|NCT00352196|Other|Magnetic Resonance Spectroscopy|Subjects will receive a standard MRS to assess the concentrations and ratios of brain metabolites N-acetylaspartate, creatine, phosphocreatine, and choline.
16339515|NCT00352183|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40mg
16339516|NCT00352183|Drug|Simvastatin|Simvastatin 40mg
16339517|NCT00352170|Dietary Supplement|calcium supplementation|calcium carbonate 1500 mg/day
16339518|NCT00352170|Dietary Supplement|calcium and vitamin D3 supplementation|calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
16339519|NCT00352170|Dietary Supplement|Placebo|calcium and vitamin D3 placebo
16339520|NCT00352157|Behavioral|Revival Soy Dietary Supplement|
16339521|NCT00352144|Drug|Eszopiclone|Eszopiclone 3 mg
16339522|NCT00352144|Drug|Placebo|Placebo tablet
16339523|NCT00352131|Drug|HuC242-DM4|Dose escalation study to define maximum tolerated dose. Doses will vary per cohort. Patients will receive an IV infusion once every three weeks.
16339524|NCT00352118|Biological|filgrastim|subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
16339525|NCT00352118|Biological|pegfilgrastim|If applicable on day 5, repeating every 3 weeks for 2 courses.
16339526|NCT00352118|Drug|cisplatin|Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
16339527|NCT00352118|Drug|docetaxel|Intravenous over 1 hour on day 1.
16339528|NCT00352118|Drug|fluorouracil|Intravenous continuously on days 1-4.
16339529|NCT00352118|Procedure|conventional surgery|As appropriate, neck dissection.
16339530|NCT00352118|Radiation|radiation therapy|60 Gy 5 days/week x 6 weeks with cisplatin
16339531|NCT00352105|Drug|cisplatin|20mg/m2/d IV continuous infusion x4 days
16339532|NCT00352105|Drug|fluorouracil|1000mg.m2/d IV continuous x 4 days
16339533|NCT00352105|Drug|Iressa|250mg/PO qd x 2 years
16339534|NCT00352105|Radiation|hyperfractionated radiation therapy|120cGy bid
16339535|NCT00352092|Drug|calcineurin inhibitor|
16339536|NCT00352092|Drug|sirolimus|
16339537|NCT00352092|Drug|mycophenolate mofetil|
16339538|NCT00352079|Biological|BCG vaccine|"Intravesical BCG:
~Induction:
~q weekly x 6 (cycle 1)
~Maintenance:
~q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months post- 2 randomization (cycles 2 - 8)"
16339539|NCT00352079|Drug|gefitinib|Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)
16351631|NCT00253240|Procedure|Management|
16339540|NCT00352079|Procedure|quality-of-life assessment|Each cycle and at 3 and 6 months after treatment discontinuation
16339541|NCT00352066|Drug|apricitabine|
16339542|NCT00352053|Drug|Tenofovir DF|Tenofovir DF 300-mg tablet, administered orally, daily + OBR
16339543|NCT00352053|Drug|Placebo|Tenofovir DF Placebo administered orally, daily + OBR
16339544|NCT00352027|Drug|Adriamycin®|Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.
16339545|NCT00352027|Drug|Vinblastine|Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.
16339546|NCT00352027|Drug|Nitrogen Mustard|Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.
16339547|NCT00352027|Drug|Cyclophosphamide|May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.
16339548|NCT00352027|Drug|Vincristine|Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
16339549|NCT00352027|Drug|Bleomycin|Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
16339550|NCT00352027|Drug|Etoposide|Given IV on Days 1 and 2 of weeks 1-10.
16339551|NCT00352027|Drug|Prednisone|Given PO every other day of weeks 1-12.
16339552|NCT00352027|Biological|G-CSF|Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).
16339553|NCT00352027|Procedure|Radiotherapy|Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.
16339554|NCT00352001|Drug|azacitidine|Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
16339555|NCT00352001|Drug|lenalidomide|Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
16339556|NCT00351988|Behavioral|Phenomenological Interviews|Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
16339557|NCT00351988|Behavioral|Quantitative Interviews|Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
16339558|NCT00351975|Drug|Belinostat|Given IV
16339559|NCT00351975|Drug|Azacitidine|Given SC
16339560|NCT00351975|Other|Laboratory Biomarker Analysis|Correlative studies
16339561|NCT00351962|Procedure|Fractionated Stereotactic Radiotherapy|
16339562|NCT00351949|Biological|IMP321|subcutaneous injections of IMP321 every 14 days for three months (6 injections. Doses tested: 50, 250, 1,250, 6,250 or 30,000 µg
16339563|NCT00351936|Drug|Aripiprazole|
16339564|NCT00351936|Drug|placebo|
16339565|NCT00351923|Biological|MeMuRu-OKA (study vaccine)|
16339566|NCT00351910|Drug|Quetiapine|
16339567|NCT00351910|Drug|Amitriptyline|
16339568|NCT00351910|Drug|Bupropion|
16339569|NCT00351910|Drug|Citalopram|
16339570|NCT00351910|Drug|Duloxetine|
16339571|NCT00351910|Drug|Escitalopram|
16339572|NCT00351910|Drug|Fluoxetine|
16339573|NCT00351910|Drug|Paroxetine|
16339574|NCT00351910|Drug|Sertraline|
16339575|NCT00351910|Drug|Venlafaxine|
16339576|NCT00351897|Device|pulsed dye (585nm) laser therapy|
16339577|NCT00351884|Drug|Vildagliptin AM|
16339578|NCT00351884|Drug|vildagliptin pm|
16339579|NCT00351884|Drug|placebo|
16339580|NCT00351871|Drug|PEG-Intron Plus REBETOL|
16339581|NCT00351858|Drug|ertumaxomab|
16339582|NCT00351845|Behavioral|Low carbohydrate diet (behavior)|
16339583|NCT00351832|Drug|Vildagliptin|
16339584|NCT00351819|Drug|AndroGel|5g gel, applied once daily to the upper arms, upper back or shoulders.
16339585|NCT00351819|Other|Placebo|5g gel, applied once daily to the upper arms, upper back or shoulders.
16339586|NCT00351806|Drug|Erigeron breviscapus injection|
16339587|NCT00351806|Drug|hua tuo zai zao wan (a herbal medicine pill)|
16339588|NCT00351806|Drug|Compound stroke herbal medicine (8 herbal)|
16339589|NCT00351793|Device|Knee Implant|Total knee replacement with Genesis II posterior stabilized knee
16339590|NCT00351780|Device|FFR measurement, side branch angioplasty|
16339591|NCT00351767|Drug|placebo|Topically applied
16339592|NCT00351767|Drug|telbermin|Topically applied
16339593|NCT00351754|Drug|Isovue|
16339594|NCT00351741|Device|Ventilation - High Frequency Percussive Ventilation|Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
16339595|NCT00351741|Device|Ventilation - ARDSnet|Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
16339596|NCT00351715|Drug|Sublingual Methadone|
16339597|NCT00351702|Drug|Isoniazid with Ethambutol|Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
16339598|NCT00351689|Behavioral|dietary supplement|
16339599|NCT00351676|Behavioral|Integration of a team based clinical pharmacist|
16339600|NCT00351676|Drug|Optimizing therapeutic treatments|
16339601|NCT00351676|Behavioral|Optimizing processes of care|
16339602|NCT00351663|Drug|Enoxaparine|"Patients considered eligible will be divided into 2 groups- those receiving vasopressor support and those not receiving vasopressor support at the time of inclusion. The patients in each group will be randomized to receive enoxaparin in accordance with one of the following DVT prophylaxis protocols:
~Intravenous Enoxaparine according to their weight (0.5mg/kg x 1/day)
~Subcutaneous Enoxaparine according to their weight (0.5mg/kg x 1/day)
~Subcutaneous Enoxaparine 40mg x1/day"
16339603|NCT00351637|Drug|Sublingual Methadone|
16339604|NCT00351624|Behavioral|DHA|
16339605|NCT00351624|Behavioral|placebo|
16339606|NCT00351611|Drug|Lyrica (pregabalin)|150 mg twice a day, oral administration
16339607|NCT00351611|Drug|placebo|Twice a day, oral administration
16339608|NCT00351598|Radiation|Definitive Radiotherapy|60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.
16339609|NCT00351585|Drug|Vildagliptin|
16339610|NCT00351572|Procedure|Cell Search Assay|
16339611|NCT00351559|Device|AlloMap molecular expression testing|
16339612|NCT00351559|Procedure|Right ventricular endomyocardial biopsy|
16339613|NCT00351546|Drug|Vildagliptin|
16339614|NCT00351533|Drug|Fish oil (eicosapentaenoic acid and docosahexanoic acid)|Liquid fish oil 7.5cc enterally every 6 hours
16339615|NCT00351520|Drug|Miltefose|
16339616|NCT00351507|Drug|Vildagliptin|
16339617|NCT00351494|Procedure|contrast enhanced ultrasonography|"Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.
~Abdominal route 2.4 ml sonovue per injection / bolus"
16339618|NCT00351494|Procedure|embolization|Intervention is described in the case report form for each patient
16339619|NCT00351468|Drug|eltrombopag olamine (SB-497115-GR)|Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.
16339620|NCT00351455|Behavioral|smoking cessation|
16339621|NCT00351455|Behavioral|tighter diabetic control|
16339622|NCT00351455|Behavioral|diet and exercise program|
16339623|NCT00351429|Device|Polyglycolic acid suture|PGA suture used in Trabeculectomy surgery
16339624|NCT00351416|Drug|Letrozole|Letrozole 20 mg orally one time
16339625|NCT00351416|Drug|NAL-GLU GnRH antagonist|5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
16339626|NCT00351403|Drug|Ribavirin|Rebetol 200 mg: applied as hard capsule
16339627|NCT00351403|Drug|Peginterferon alfa 2b|PegIntron (50/80/100/120/150 microgram): applied by injection
16339628|NCT00351390|Other|Drug therapy for HF|Titration of HF meds in an aggressive out patient manner following guideline direction
16339629|NCT00351390|Other|NT-proBNP guided HF therapy|Standard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP <1000 pg/mL
16339630|NCT00351377|Drug|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.
16339631|NCT00351364|Drug|Montelukast Sodium|100 mg P.O. One time only
16339632|NCT00351351|Device|Cyberwand|FDA approved - dual probe intracorporeal lithotrite
16339633|NCT00351351|Device|single probe ultrasonic|FDA-approved - single probe ultrasonic
16339634|NCT00351325|Drug|BMS-663513|mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks
16339635|NCT00351312|Device|special socks|
16339636|NCT00351299|Drug|Dexmedetomidine|dexmedetomidine infusion titrated to effect
16339637|NCT00351299|Other|Standard of Care|Standard of care per treating physician preference
16339638|NCT00351286|Drug|L-citrulline tablets, 1000 mg|
16339639|NCT00351286|Drug|Placebo tablets matching L-citrulline tablets|
16339640|NCT00351286|Drug|Background simvastatin at a stable dose of 40 mg qHS|
16339641|NCT00351273|Drug|Doxycycline and Rifampin|doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)
16339642|NCT00351273|Drug|Azithromycin and Rifampin|Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)
16339643|NCT00351273|Drug|Placebo|Methylcellulose
16339644|NCT00351260|Procedure|Coronary Angioplasty|
16339645|NCT00351247|Procedure|Postconditioning|
16339646|NCT00351234|Drug|Carnitine (drug)|Oral L-carnitine will be obtained from Sigma Tau Pharmaceuticals. Supplementation will be initiated at 50mg/kg body weight and increased to 100mg/kg body weight after one week.
16339647|NCT00351221|Drug|rhIGF-1/rhIGFBP-3|
16339648|NCT00351208|Device|Medtronic Manufactured Spinal Cord Stimulators|
16339649|NCT00351195|Drug|Etoposide|
16339650|NCT00351195|Drug|Oxaliplatin|
16339651|NCT00351195|Drug|Capecitabine|
16339652|NCT00351182|Drug|Telithromycin|
16339653|NCT00351182|Drug|Doxycycline|
16339654|NCT00351169|Drug|Quetiapine SR|
16339655|NCT00351169|Drug|Escitalopram|
16339656|NCT00351156|Procedure|Blood sample|
16339657|NCT00351143|Drug|salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training|Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
16339658|NCT00351143|Drug|salmeterol/fluticasone propionate 50/250 µg|Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
16339659|NCT00351130|Drug|valsartan|
16339660|NCT00351130|Drug|amlodipine|
16339661|NCT00351117|Drug|St. John's Wort|SJW in capsule form 300 mg PO TID
16339662|NCT00351117|Drug|Lactose|lactose in gelatin capsule that same as St. John's wort
16339663|NCT00351104|Drug|Ketoprofen Topical Patch 20%|
16339664|NCT00351091|Drug|RISEDRONATE|
16339665|NCT00351078|Drug|PTC124|4-,4-, and 8-mg/kg PO first 14 days 10-, 10-, and 20-mg/kg TID second 14 days
16339666|NCT00351065|Drug|SK3530|
16339667|NCT00351052|Drug|Pimecrolimus|Pimecroliums cream 1 % bid.
16339668|NCT00351052|Drug|Placebo|Vehicle control (placebo) bid.
16339669|NCT00351039|Drug|Bevacizumab|Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.
16339670|NCT00351039|Drug|Erlotinib|Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days.
16339671|NCT00351039|Drug|Pemetrexed|Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.
16339672|NCT00351026|Drug|Methadone|short-term methadone maintenance
16339673|NCT00351013|Other|Malaria Tropica Nosode D200|5 pellets every four months
16339674|NCT00351000|Drug|Ziprasidone|
16339675|NCT00350987|Behavioral|a strategy based on PCT guided AB therapy|In this study a strategy based on PCT guided AB therapy with enforced guideline implementation will be compared.
16339676|NCT00350961|Drug|Gemcitabine|
16339677|NCT00350961|Drug|Oxaliplatin|
16339678|NCT00350961|Drug|Capecitabine|
16339679|NCT00350948|Drug|Telcyta|Day 1 of 28 day Cycle.
16339680|NCT00350948|Drug|Liposomal Doxorubicin|Day 1 of 28 Day Cycle. 50 mg/m2
16339681|NCT00350935|Procedure|fMRI|One 30 minute session
16339682|NCT00350922|Behavioral|Psychoeducation|
16339683|NCT00350909|Behavioral|brief intervention (cognitive-behavioral therapy)|Consists of 60 minute individual sessions delivered with a therapist using a motivational interviewing (MI) style. Session 1 focuses on eliciting information about the students' substance use and related consequences based on the assessment, their perception of level of willingness to change, examining the cause and benefits of change using the decisional balance exercise, and discussing what goals for change the student would like to select and pursue. Session 2 reviewed the students' progress with the agreed upon goals, identifying high risk situations associated with clients difficulty in achieving the goals, discussing strategies to address barriers toward goal attainment, reviewing where the client is in the stage of change process, and negotiating either the continuation of goals or advancing to more ambitious goals of substance use reduction. Session 3 involved delivering the same MI interviewing style to the primary parent or guardian (student is not present).
16339684|NCT00350896|Device|Thumb orthoses|
16339685|NCT00350883|Behavioral|Cognitive Therapy|Goal-oriented talk therapy
16339686|NCT00350883|Other|Treatment as Usual|Keep getting usual care
16339687|NCT00350870|Drug|disulfiram|250mg per day of Disulfiram plus CBT
16339688|NCT00350870|Drug|Placebo|Placebo plus CBT
16339689|NCT00350870|Behavioral|Placebo plus Contingency Management|Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
16339690|NCT00350870|Drug|Disulfiram plus Contingency Management|250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
16339691|NCT00350857|Drug|Extended-Release Carbamazepine|
16339692|NCT00350844|Drug|Hydroxyurea|20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
16339693|NCT00350831|Drug|XL820|
16339694|NCT00350818|Drug|Azacitidine|8 mg/m^2 Subcutaneously Once Daily for 5 Days
16339695|NCT00350805|Procedure|EEG|One 20 minutes session
16339696|NCT00350792|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles
16339697|NCT00350792|Drug|carboplatin|Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
16339698|NCT00350779|Drug|sitagliptin|Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.
16339699|NCT00350779|Drug|Comparator: Placebo|Placebo to sitagliptin 100mg tablet each day for 54 weeks.
16339700|NCT00350779|Drug|rosiglitazone|Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
16339701|NCT00350779|Drug|metformin|Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
16339702|NCT00350779|Drug|glipizide|Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)
16339703|NCT00350766|Procedure|Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation|Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.
16339704|NCT00350753|Drug|Erlotinib and bevacizumab|Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days
16339705|NCT00350727|Drug|pazopanib|Pazopanib is a novel compound being developed for the treatment of various cancers.
16339706|NCT00350727|Drug|lapatinib|Lapatinib is a novel compound being developed for the treatment of various cancers.
16339707|NCT00350714|Other|MBT and BreathID|75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion.
16339708|NCT00350701|Drug|androgel|androgel 5g
16339709|NCT00350701|Drug|androgel 10g|androgel 10g
16339710|NCT00350701|Drug|placebo|placebo
16339711|NCT00350688|Radiation|Helical tomotherapy IMRT|Helical tomotherapy IMRT
16339712|NCT00350662|Drug|Deferiprone (L1)|75 mg/kg body weight daily
16339713|NCT00350662|Drug|Desferrioxamine|In combination with deferiprone: 40-50 mg/kg body weight 2-times weekly As single agent: 40-50 mg/kg body weight 5- to 7-times weekly
16339714|NCT00350649|Behavioral|Standard CBT|Manualized delivery of CBT by trained clinicians
16339715|NCT00350649|Behavioral|CBT+CM/adherence|CBT and Clinical Management for attendance and completing homework
16339716|NCT00350649|Behavioral|CM/abstinence|Contingency Management
16339717|NCT00350649|Behavioral|CM/abstinence+CBT|Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician
16339718|NCT00350636|Drug|Oxybutynin topical gel|1 application daily to skin for 12 weeks
16339719|NCT00350636|Other|Placebo topical gel|1 application daily to skin for 12 weeks
16339720|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
16339721|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
16339722|NCT00350623|Biological|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)|3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
16339723|NCT00350610|Other|Treatment as usual (TAU)|Standard treatment as usual in a community based treatment setting
16339724|NCT00350610|Behavioral|CBT for CBT|Standard treatment as usual (TAU) plus computer based therapy using CBT
16353255|NCT00238901|Drug|Basiliximab|
16339725|NCT00350597|Drug|Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)|
16339726|NCT00350584|Behavioral|Mindfulness Telehealth Intervention|Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
16339727|NCT00350584|Behavioral|Psychoeducation Telehealth Intervention|Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.
16339728|NCT00350571|Behavioral|brief (behavioral therapy)|up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.
16339729|NCT00350571|Behavioral|Drop out re-engagement motivational intervention|Up to 3 phone or office based counseling sessions to promote reengagement in treatment
16339730|NCT00350571|Behavioral|standard care follow up|routine counselor phone calls and letters
16339731|NCT00350545|Drug|Rituximab|375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
16339732|NCT00350545|Drug|Prednisone|1 mg/kg; po per day with taper
16339733|NCT00350545|Drug|Cyclosporine A|trough 200-300 or lower; po
16339734|NCT00350545|Drug|tacrolimus|trough 5-10 or lower; po
16339735|NCT00350532|Drug|clonidine|Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
16339736|NCT00350532|Drug|clonidine|Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
16339737|NCT00350519|Drug|Epoetin alfa|Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
16339738|NCT00350519|Drug|Standard of Care|Participants will receive standard of care based on the Institution's treatment policy.
16339739|NCT00350506|Device|64 Channel VCT|
16339740|NCT00350480|Drug|Provera|
16339741|NCT00350480|Drug|Combination Birth Control pills|
16339742|NCT00350467|Drug|ER OROS paliperidone and Olanzapine|
16339743|NCT00350454|Device|rapamycin-eluting Stent with permanent polymer|due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
16339744|NCT00350454|Device|rapamycin-eluting stent with biodegradable polymer|due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
16339745|NCT00350454|Device|polymer-free, rapamycin-eluting stent|due to randomization, polymer-free.rapamycin-eluting stent will be implanted
16339746|NCT00350441|Drug|Sildenafil Citrate|
16339747|NCT00350428|Procedure|Laser Preipheral Iridotomy and phacoemulsification|
16339748|NCT00350415|Drug|Mesalamine|"Asacol 400g/day (400 mg tablet), oral, for 6 weeks
~OR
~Asacol 4,8 g/day (800 mg table), oral, for 6 weeks"
16339749|NCT00350402|Behavioral|Respiratory muscle strength training|The Muscle Stength Training (MST)device is a mouthpiece that the participant uses to inspire against controlled resistance; Intervention involves use of this device for breathing exercises over 4 week period, 5 days a week, approximately 20 minutes/day.
16339750|NCT00350389|Behavioral|Outdoor use of plain distance glasses with counselling|Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
16339751|NCT00350363|Drug|Zymar|zymar qid
16339752|NCT00350350|Device|oxygenated oil|oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day
16339753|NCT00350350|Device|medical device. Spray containing essentially oxygenated oil|"protective oral spray containing :
~94.4% of oxygenated oil
~Silicium dioxide
~aspartame artificial flavoring"
16339754|NCT00350337|Biological|Pre-transfection F17|Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
16339755|NCT00350337|Biological|Post-transfection F17|Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
16339756|NCT00350337|Biological|Post-transfection F19|Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
16339757|NCT00350337|Other|Placebo|Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
16339758|NCT00350311|Drug|nicotine transdermal patch/lozenge|
16339759|NCT00350298|Biological|GS-CDA1/MDX-1388|One Intravenous dose
16339760|NCT00350298|Biological|normal saline|One Intravenous dose
16339761|NCT00350285|Behavioral|Motivational enhancement therapy|Personal feedback with counselor using motivational interviewing strategies.
16339762|NCT00350285|Behavioral|Marijuana education|Information about health and behavioral effects of marijuana use.
16339763|NCT00350272|Drug|elvucitabine|elvucitabine 10 mg orally daily
16339764|NCT00350272|Drug|Lamivudine|lamivudine 300 mg orally daily
16339765|NCT00350272|Drug|Tenofovir|tenofovir open-label 300 mg orally daily
16339766|NCT00350272|Drug|Efavirenz|efavirenze open-label 600 mg orally daily
16339767|NCT00350246|Procedure|Laser Refractive Surgery|
16339768|NCT00350233|Device|ExAblate 2000|
16339769|NCT00350220|Other|transfusion strategy|For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
16339770|NCT00350220|Other|Low Hb transfusion group|RBCs will not be transfused unless the Hb < 9.0 g/dl
16339771|NCT00350207|Drug|Tiotropium bromide|
16339772|NCT00350207|Drug|Placebo|
16339773|NCT00350207|Drug|Salmeterol xinafoate|
16339774|NCT00350194|Dietary Supplement|Omega-3 fatty acids|Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
16339775|NCT00350181|Drug|Sirolimus|Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults
16339776|NCT00350181|Drug|MMF|Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion
16339777|NCT00350181|Drug|BCNU|15 mg/kg, IV
16339778|NCT00350181|Drug|VP-16|60 mg/kg, IV
16339828|NCT00349765|Behavioral|higher fat, high polyunsaturated fat diet|
16339829|NCT00349765|Behavioral|higher fat, high saturated and trans fat diet|
16339830|NCT00349765|Behavioral|lower fat diet|
16339779|NCT00350181|Drug|CY|For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg
16339780|NCT00350181|Drug|FTBI|1320 cGy delivered in 11 120 cGy fractions over 4 day
16339781|NCT00350181|Drug|BU|BU 1 mg/kg every 6hr x 4 doses, IV
16339782|NCT00350168|Drug|valsartan + amlodipine|
16339783|NCT00350155|Drug|Lumiracoxib|
16339784|NCT00350142|Radiation|Stereotactic Body Radiotherapy|Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
16339785|NCT00350142|Drug|Gemcitabine|Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
16339786|NCT00350142|Other|4D pancreatic protocol CT scan|Patients will undergo this imaging procedure prior to treatment for planning purposes.
16339787|NCT00350142|Radiation|FDG PET scan|Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
16339788|NCT00350116|Drug|topical vitamin B12|
16339789|NCT00350103|Drug|SPM 929|
16339790|NCT00350090|Drug|Epoetin Alfa|
16339791|NCT00350077|Drug|Intravenous Vitamin C|vitamin C IV during 24 hour period following burn
16339792|NCT00350077|Drug|Vitamin C|IV vitamin C
16339793|NCT00350064|Behavioral|Exercise Training|16 weeks of aerobic exercise training at two different intensities
16339794|NCT00350051|Drug|Sagopilone (ZK 219477) + prednisone|Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.
16339795|NCT00350038|Drug|Irbesartan|
16339796|NCT00350038|Drug|Ciprofibrate|
16339797|NCT00350025|Drug|Cetuximab|Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
16339798|NCT00350025|Drug|Paclitaxel|Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
16339799|NCT00349986|Drug|Insuline glargine|
16339800|NCT00349973|Drug|Dipyridamole|Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
16339801|NCT00349973|Other|Olanzapine|Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
16339802|NCT00349960|Drug|NeoRecormon SC once-weekly versus once-every-other-week|
16339803|NCT00349947|Behavioral|Exercise Program|Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor.
16339804|NCT00349934|Biological|IMP321|"This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle).
~Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration.
~The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy."
16339805|NCT00349921|Drug|clonidine|Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.
16339806|NCT00349921|Drug|adenosine|Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
16339807|NCT00349921|Drug|placebo|inactive substance
16339808|NCT00349921|Drug|placebo|inactive substance
16339809|NCT00349908|Device|Cordis Neurovascular ENTERPRISE Self Expanding Stent System|Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
16339810|NCT00349908|Device|Cordis Neurovascular ENTERPRISE Self Expanding Stent System|Implantation of the device ENTERPRISE to treat wide-necked aneurysms
16339811|NCT00349895|Device|Coronary stent implantation|Percutaneous Coronary Intervention
16339812|NCT00349882|Device|soft contact lens|
16339813|NCT00349882|Drug|Marketed multipurpose disinfection regimen|
16339814|NCT00349869|Behavioral|yoga|8-week yoga program.
16339815|NCT00349856|Device|Biofinity|Soft contact lens
16339816|NCT00349843|Device|Soft contact lens|
16339817|NCT00349843|Drug|Marketed soft lens multipurpose disinfection regimen|
16339818|NCT00349830|Procedure|blood draw|
16339819|NCT00349817|Behavioral|web-based learning, didactic lecture and role-play|
16339820|NCT00349804|Other|cool dry air|cool dry air (0.22-0.28 m3/min at 15-18 Degrees C)
16339821|NCT00349791|Drug|Testosterone Transdermal System|testosterone (300 mcg/day) patch replaced twice a week for two years
16339822|NCT00349791|Drug|Placebo patch|placebo patch replaced twice a week for two years
16339823|NCT00349778|Drug|Cyclophosphamide|Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in ~250 mL of saline or D5W and infused IV over 2 hours
16339824|NCT00349778|Drug|Etoposide|100 mg etoposide as 5 mL solution in clear ampules for injection.
16339825|NCT00349778|Drug|Melphalan|Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.
16339826|NCT00349778|Drug|Carmustine|Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.
16339827|NCT00349778|Drug|Filgrastim|Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
16339831|NCT00349752|Biological|certolizumab pegol 400 mg|Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
16339832|NCT00349752|Other|Placebo|Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
16339833|NCT00349739|Drug|Anecortave Acetate|Dosage: 0.5ml of 30mg/ml(15 mg) or 60mg/ml(30mg) Duration of action: 159-180 days
16339834|NCT00349726|Drug|Inositol lower volume|60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
16339835|NCT00349726|Drug|Inositol higher volume|120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
16339836|NCT00349726|Drug|Placebo lower volume|60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.
16339837|NCT00349726|Drug|Placebo higher volume|120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.
16339838|NCT00349713|Biological|FMP2.1/AS02A|FMP2.1 in GSK Biologicals' AS02A
16339839|NCT00349713|Biological|Rabies vaccine (RabAvert)|RabAvert Rabies vaccine
16339840|NCT00349700|Procedure|Compression: 2 weeks four layer bandages, then stockings|
16339841|NCT00349700|Procedure|debridement|
16339842|NCT00349700|Procedure|Actisorb plus (r) + Trionic(r)/ Allevyn (r)|
16339843|NCT00349687|Behavioral|self-control practice|
16339844|NCT00349674|Drug|Azathioprine: 2 mg/kg/day|
16339845|NCT00349674|Drug|methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week|
16339846|NCT00349661|Drug|impact on VASP test|
16339847|NCT00349648|Procedure|acromioplasty|
16339848|NCT00349635|Drug|Metformin and Metformin + Fenofibrate|
16339849|NCT00349622|Drug|ceftriaxone|"Participants will be randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants will receive ceftriaxone and one third will receive placebo. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
~Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to people over a long period of time, such as months or years."
16339850|NCT00349622|Other|placebo|an inactive substance
16339851|NCT00349596|Drug|Decitabine|Administered intravenously (IV) over 1 hour at 10 mg/m2 daily x 5 days every other week.
16339852|NCT00349583|Drug|Topical Cyclosporine, Tears|
16339853|NCT00349570|Device|Xtract Aspiration Catheter|
16339854|NCT00349557|Drug|bevacizumab, bicalutamide and goserelin|
16339855|NCT00349557|Procedure|intensity modulated radiation therapy (IMRT)|
16339856|NCT00349531|Drug|Pramipexole|
16339857|NCT00349518|Drug|Dasatinib|
16339858|NCT00349505|Procedure|hyper thermic chemo + surgery|
16339859|NCT00349492|Drug|IP|irinotecan+cisplatin
16339860|NCT00349479|Behavioral|Barrier assessment / interactive educational intervention|"Intervention hospitals received a barrier assessment - interactive educational intervention (BA-IEI) which included: on-site barrier assessment, annual stroke champions meetings, stroke center telephone access, quarterly mock stroke codes, and ongoing feedback and education."
16339861|NCT00349466|Drug|CF101|Orally CF101 1mg
16339862|NCT00349466|Drug|Placebo|Orally matching Placebo
16339863|NCT00349453|Drug|Deferiprone (L1)|50-100 mg/kg body weight daily
16339864|NCT00349453|Drug|Deferiprone (L1)|75 mg/kg body weight daily
16339865|NCT00349453|Drug|Desferrioxamine|35-50 mg/kg body weight on 2 or more days per week
16339866|NCT00349440|Drug|Cyclosporine, Refresh Plus|"Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.
~Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily."
16339867|NCT00349427|Drug|Rosiglitazone 4 mg|
16339868|NCT00349414|Procedure|Micropulse Transscleral Cyclophotocoagulation|
16339869|NCT00349414|Procedure|Conventional Transscleral Cyclophotocoagulation|
16339870|NCT00349401|Drug|ketorolac|
16339871|NCT00349401|Drug|morphine|
16339872|NCT00349388|Drug|Asacol|Asacol is given once a day versus twice or three times a day
16339873|NCT00349375|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate 145mg and Simvastatin 20mg
16339874|NCT00349375|Drug|Fenofibrate/Simvastatin|Combination of Fenofibrate and Simvastatin 40 mg
16339875|NCT00349375|Drug|Simvastatin|Simvastatin 40 mg
16339876|NCT00349362|Drug|Testosterone|Sustanon- 200mg intramuscular testosterone
16339877|NCT00349362|Drug|0.9% saline|Saline intramuscular injection every two weeks
16339878|NCT00349349|Drug|ofatumumab|Intravenous infusion
16339879|NCT00349336|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3 week cycle
16339880|NCT00349336|Drug|XELOX|As prescribed
16339881|NCT00349336|Drug|bevacizumab [Avastin]|5mg/kg iv on day 1 of each 2 week cycle
16339882|NCT00349336|Drug|FOLFOX-4|As prescribed
16339883|NCT00349323|Behavioral|Community directed treatment|
16339884|NCT00349310|Drug|Pramipexole|
16339885|NCT00349284|Drug|Combination of 145 mg fenofibrate and 10 mg ezetimibe|
16339886|NCT00349271|Procedure|Stem cell|Stem cell
16339887|NCT00349271|Drug|Filgrastime (G-CSF)|Filgrastime (G-CSF)
16339888|NCT00349271|Drug|Standart therapy|All drug with clinical evidence of benefical effect in Chagas disease
16339889|NCT00349258|Drug|Leuprolide acetate|
16339890|NCT00349245|Drug|Remifentanil|
16339891|NCT00349245|Drug|Dexmedetomidine|
16339892|NCT00349232|Behavioral|lifestyle intervention (diet and physical activity)|
16339893|NCT00349219|Drug|erlotinib|erlotinib 150 mg taken orally daily until disease progression
16339894|NCT00349219|Drug|cisplatin|cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
16339895|NCT00349219|Drug|gemcitabine|gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
16339896|NCT00349219|Drug|cisplatin|cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
16339897|NCT00349219|Drug|gemcitabine|gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
16339898|NCT00349219|Drug|erlotinib|erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)
16339899|NCT00349206|Drug|sorafenib tosylate|Given orally
16339900|NCT00349206|Drug|temsirolimus|Given IV
16339901|NCT00349193|Drug|laquinimod 0.3|laquinimod 0.3mg
16339902|NCT00349193|Drug|laquinimod 0.6|laquinimod 0.6mg
16339903|NCT00349193|Other|Placebo|Blinded Placebo
16339904|NCT00349180|Drug|Enoxaparin sodium|
16339905|NCT00349167|Drug|PR-104|
16339906|NCT00349167|Other|laboratory biomarker analysis|
16339907|NCT00349167|Other|pharmacological study|
16339908|NCT00349141|Biological|Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen|
16339909|NCT00349128|Drug|fenofibrate and metformin combination (drug)|
16339910|NCT00349115|Drug|Thalidomide|
16339911|NCT00349102|Radiation|Free breathing|Free breathing during conformal radiation
16339912|NCT00349102|Radiation|Breath holding|Breath holding during conformal radiation
16339913|NCT00349089|Drug|Pemetrexed|Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22
16339914|NCT00349089|Drug|Cisplatin|"Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22
~Comparator:
~Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29 Cisplatin 50 mg/m2 d1, 8; q d29"
16339915|NCT00349089|Drug|Vinorelbine|Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29
16339916|NCT00349076|Drug|5-FU and oxaliplatin|"Preoperative radiochemotherapy:
~Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35
~Adjuvant Chemotherapy:
~Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours repeat day 15, 8 cycles"
16339917|NCT00349076|Drug|5-FU|"Preoperative radiochemotherapy:
~5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d
~Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles"
16339918|NCT00349063|Device|soft contact lens|
16339919|NCT00349063|Drug|Soft contact lens multipurpose disinfection regimen|
16339920|NCT00349050|Device|laboratory pain assessment|Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
16339921|NCT00349050|Procedure|transcranial magnetic stimulation|"There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and sham TMS (which does not involve real stimulation) for the second treatment. Group B will receive sham TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and sham TMS."
16339922|NCT00349037|Biological|Trivalent DNA vaccine with and without pPJV2012 administered by PMED|
16339923|NCT00349024|Drug|polyvinylpyrrolidone-sodium hyaluronate gel|
16339924|NCT00349011|Procedure|Personalized risk assessment|
16339925|NCT00349011|Procedure|genetic counseling intervention|
16339926|NCT00348998|Biological|bevacizumab|
16339927|NCT00348998|Drug|bicalutamide|
16339928|NCT00348998|Drug|goserelin acetate|
16339929|NCT00348998|Radiation|radiation therapy|
16339930|NCT00348985|Drug|belinostat|
16339931|NCT00348985|Drug|bortezomib|
16339932|NCT00348985|Other|pharmacological study|
16339933|NCT00348972|Drug|Lantus® (insulin glargine)|
16339934|NCT00348959|Behavioral|'Open Window' Project|"Open Window' is an entirely art based intervention comprising a multimedia system that uses a combination of video projectors, audio speakers and bespoke software to make images appear as a 'virtual window' on the wall of the patients' room. Artists use mobile phone cameras and camcorders to record the images that are sent to the unit over the internet and via mobile phone networks. Original music composed for the project may also accompany the images as they appear.
~Artists are commissioned to create work for the 'Open Window' project and are aware of the nature of the viewer and the context in which the art will be shown. The art in 'Open Window' encourages the viewer to think about and engage in what they see from their own personal frame of reference."
16339935|NCT00348946|Drug|androgen oxandrolone|Oxandrolone ,06 >mg/kg/day, orally, for 2 years
16339936|NCT00348946|Other|placebo|an inactive substance
16339937|NCT00348933|Drug|Betaine|100-200 mg per kg per day by mouth with a maximum of 6 grams divided in two daily doses
16339938|NCT00348933|Drug|Creatine|200 mg per kg per day with a daily maximum of 5 grams divided in two daily doses
16339939|NCT00348933|Drug|Metafolin|0.5 mg per kg per day by mouth with a maximum of 8 milligrams divided in two daily doses
16339940|NCT00348933|Drug|Vitamin B12|1 mg by mouth per day for all weights and ages
16339941|NCT00348920|Procedure|High Spinal and General Anesthesia|Spinal bupivacaine 0.75% in dextrose, 6 mls (45mg) and preservative free morphine 3 mcg/kg (to a maximum of 300 mcg).
16339942|NCT00348907|Drug|thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
16339943|NCT00348907|Drug|late thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years
16339944|NCT00348894|Drug|[S,S]-Reboxetine|[S,S]-reboxetine
16339945|NCT00348894|Drug|Any|Any standard of care treatment for DPN
16339946|NCT00348881|Biological|DTaP-HB-PRP~T combined vaccine|0.5 mL, Intramuscular
16339947|NCT00348881|Biological|Tritanrix-HepB/Hib™ vaccine|0.5 mL, Intramuscular
16339948|NCT00348881|Biological|Oral poliomyelitis vaccine (OPV)|Oral co-administered with study vaccine.
16339949|NCT00348868|Behavioral|enhanced behavioral motivation counseling|
16339950|NCT00348868|Behavioral|Motivational counseling|
16339951|NCT00348868|Behavioral|Standard counseling|
16339952|NCT00348855|Other|Cardiovascular drugs strategies|Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.
16339953|NCT00348855|Behavioral|Compliance|Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.
16340016|NCT00348335|Drug|Ocular lubricant|
16339954|NCT00348855|Behavioral|Exercise|Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.
16339955|NCT00348855|Behavioral|Stop Smoking|Minimal intervention
16339956|NCT00348855|Behavioral|Diet|Discussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2.
16339957|NCT00348855|Other|Feed Back|Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
16339958|NCT00348842|Procedure|Newcastle Virus|
16339959|NCT00348829|Procedure|mitral valve repair|surgical mitral valve repair
16339960|NCT00348816|Drug|docetaxel|Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
16339961|NCT00348816|Drug|prednisone|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
16339962|NCT00348816|Procedure|Radical prostatectomy|Radical prostatectomy as part of standard care
16339963|NCT00348816|Radiation|Radiation therapy|Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
16339964|NCT00348790|Drug|vatalanib|
16339965|NCT00348777|Drug|thermal cure|thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
16339966|NCT00348777|Drug|3 days access to watering place at 6 months|access to watering place for movement in swimming pool, sauna and hammam.
16339967|NCT00348764|Drug|lauromacrogol|
16339968|NCT00348751|Device|CholGate|
16339969|NCT00348738|Drug|Erythropoietin|Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of >14g/dl, <15g/dl is reached or until the end of the radiation therapy.
16339970|NCT00348725|Drug|fenofibrate and metformin fixed combination (drug)|
16339971|NCT00348712|Drug|rosiglitazone|Tablets, 4 mg once or twice daily.
16339972|NCT00348712|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16339973|NCT00348712|Drug|metformin|Tablets, 2000 mg/day.
16339974|NCT00348699|Drug|AFP464|Given IV
16339975|NCT00348699|Other|pharmacological study|Correlative studies
16339976|NCT00348699|Other|laboratory biomarker analysis|Correlative studies
16339977|NCT00348686|Drug|Candesartan|16 mg once daily in oral tablet form
16339978|NCT00348686|Drug|Candesartan|32 mg once daily in oral tablet form
16339979|NCT00348686|Drug|Felodipine|5 mg once daily in oral tablet form
16339980|NCT00348686|Drug|Felodipine|10 mg once daily in oral tablet form
16339981|NCT00348673|Drug|UK-453,061|Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days
16339982|NCT00348673|Drug|UK-453,061|Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
16339983|NCT00348647|Behavioral|physical training program to prevent injuries|
16339984|NCT00348634|Drug|Tegaserod|
16339985|NCT00348621|Procedure|Visual impairment intervention program|enhanced access to eye care services
16339986|NCT00348608|Drug|iodixanol|
16339987|NCT00348595|Drug|Revlimid|one 5 mg/day capsule or one 25 mg/day capsule with matched placebo capsule day 1-21 (28 day cycle)
16339988|NCT00348582|Drug|Ketorolac, Nepafenac|
16339989|NCT00348569|Device|64 Channel VCT|
16339990|NCT00348556|Drug|Nesiritide|Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.
16339991|NCT00348543|Procedure|laser treatment|
16339992|NCT00348530|Drug|Verapamil|
16339993|NCT00348517|Other|Systane Free Lubricant Eye Drops|1-2 drops per eye four times per day for 42 days
16339994|NCT00348517|Other|Refresh Liquigel Lubricant Eye Drops|1-2 drops per eye four times per day for 42 days
16339995|NCT00348504|Drug|levosimendan|
16339996|NCT00348504|Drug|dobutamine|
16339997|NCT00348491|Drug|Lumiracoxib|
16339998|NCT00348478|Behavioral|water and health education program to improve hygiene|
16339999|NCT00348465|Procedure|Brachytherapy with Iodine-125 seeds|Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS
16340000|NCT00348452|Drug|tramadol HCl ER; celecoxib|
16340001|NCT00348439|Drug|Plasmin|27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
16340002|NCT00348439|Drug|Vehicle|Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
16340003|NCT00348426|Drug|Botulinum AntiToxin|
16340004|NCT00348426|Procedure|neuro-electrophysiologic study, repetitive nerve stimulation|
16340005|NCT00348426|Procedure|: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure|
16340006|NCT00348413|Drug|Intravenous Methylprednisolone + Oral Methotrexate vs Intravenous Methylprednisolone + Placebo|
16340007|NCT00348400|Drug|Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost|
16340008|NCT00348387|Biological|Poliomyelitis Vaccine inactivated|0.5 mL, Intramuscular
16340009|NCT00348387|Biological|Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)|1g dragee, oral
16340010|NCT00348374|Drug|Insulin Lispro|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
16340011|NCT00348374|Drug|Exubera|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
16340012|NCT00348361|Drug|Fluticasone Propionate|
16340013|NCT00348348|Drug|Besifloxacin|Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
16340014|NCT00348348|Drug|Moxifloxacin solution|Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
16340015|NCT00348335|Drug|Cyclosporine 0.05%|
16340017|NCT00348322|Drug|Systane Free Lubricant Eye Drops|
16340018|NCT00348309|Drug|Rosiglitazone Extended Release 2mg|Rosiglitazone Extended Release 2mg OD
16340019|NCT00348309|Drug|Rosiglitazone Extended Release 8mg|Rosiglitazone Extended Release 8mg OD
16340020|NCT00348309|Other|Placebo|Placebo
16340021|NCT00348309|Other|Donepezil|Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
16340022|NCT00348296|Drug|High-dose intravenous immunoglobulin (Venoglobulin-IH)|
16340023|NCT00348283|Biological|adalimumab|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
16340024|NCT00348283|Biological|placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
16340025|NCT00348283|Biological|adalimumab|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
16340026|NCT00348270|Device|Tecnis Z9000 intraocular lens|
16340027|NCT00348270|Device|MA60 intraocular lens|
16340028|NCT00348257|Device|Hair removal by laser/IPL device|
16340029|NCT00348244|Drug|Ketorolac, Prednisolone Acetate|
16340030|NCT00348231|Drug|dual-action insulin analog|
16340031|NCT00348218|Device|NeuroVision|
16340032|NCT00348205|Device|Technolas 217z Zyoptix Laser|Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.
16340033|NCT00348192|Drug|SB-742457|
16340034|NCT00348192|Drug|donepezil|
16340035|NCT00348179|Procedure|Measurement of vascular function per SphymgnoCor equipment|Pressure tonometer will be used on various vessels, non-invasive.
16340036|NCT00348166|Drug|cyclopentolate|
16340037|NCT00348153|Drug|Adalimumab|
16340038|NCT00348140|Drug|Rosiglitazone Extended Release 2mg|Rosiglitazone Extended Release 2mg OD
16340039|NCT00348140|Drug|Rosiglitazone Extended Release 8mg|Rosiglitazone Extended Release 8mg OD
16340040|NCT00348140|Other|Placebo|Placebo
16340041|NCT00348127|Device|Neurovision|
16340042|NCT00348114|Procedure|Transplantation of cultivated limbal epithelium|
16340043|NCT00348101|Drug|Combined therapy with enoximone and esmolol|
16340044|NCT00348075|Device|Neurovision|
16340045|NCT00348062|Drug|Bimatoprost|
16340046|NCT00348049|Procedure|Laser in Situ Keratomileusis (LASIK)|
16340047|NCT00348049|Procedure|Photorefractive Keratectomy (PRK)|
16340048|NCT00348036|Behavioral|Group Intervention for Interpersonal Trauma|Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier.
16340049|NCT00348036|Other|Information only|Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.
16340050|NCT00348023|Drug|Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%|
16340051|NCT00348010|Drug|Tramadol HCl ER|
16340052|NCT00347997|Device|217z Laser|LASIK correction of myopia and myopic astigmatism
16340053|NCT00347984|Other|Systane Lubricant eye drops|
16340054|NCT00347971|Drug|recombinant human interleukin 21 and rituximab|rIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV
16340055|NCT00347958|Biological|Tetanus-diphtheria-acellular pertussis (Tdap) vaccine|0.5mL, Intramuscular (IM)
16340056|NCT00347945|Procedure|Pencil Push-ups|
16340057|NCT00347945|Procedure|Office-based Vision Therapy|
16340058|NCT00347945|Procedure|Placebo Office-based Vision Therapy|
16340059|NCT00347932|Drug|ISV-403|Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
16340060|NCT00347932|Drug|Vehicle|Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
16340061|NCT00347919|Drug|pazopanib (GW786034) 400 mg|400 mg administered orally once daily
16340062|NCT00347919|Drug|lapatinib (GW572016) 1500 mg|1500 mg administered orally once daily.
16340063|NCT00347919|Drug|lapatinib (GW572016) 1000 mg|1000 mg administered orally once daily
16340064|NCT00347919|Drug|pazopanib (GW786034) 800 mg|800 mg administered orally once daily
16340065|NCT00347906|Procedure|laser treatment|
16340066|NCT00347893|Procedure|Selective laser trabeculoplasty|
16340067|NCT00347867|Drug|Viagra administration in IUGR/PET pregnancies|
16340068|NCT00347854|Other|Systane Free lubricant eye drops|
16340069|NCT00347854|Other|Visine Tears Lubricant Eye Drops|
16340070|NCT00347854|Other|Refresh Liquigel Lubricant Eye Drops|
16340071|NCT00347854|Other|Refresh Plus Lubricant Eye Drops|
16340072|NCT00347841|Drug|Bimatoprost 0.03%, Latanoprost|
16340073|NCT00347828|Drug|Moxifloxacin ophthalmic solution 0.5%|
16340074|NCT00347828|Drug|Gatifloxacin ophthalmic solution 0.3%|
16340075|NCT00347815|Drug|Buprenorphine|
16340076|NCT00347802|Drug|Bimatoprost 0.03%, Travoprost 0.004%|
16340077|NCT00347789|Procedure|Glaucoma surgery- Bleb revision|
16340078|NCT00347776|Drug|azithromycin|oral antibiotic
16340079|NCT00347776|Drug|topical tetracycline|
16340080|NCT00347763|Procedure|10% permethrin in water applied as low volume spray|
16340081|NCT00347750|Drug|Lopinavir pharmacokinetic/pharmacodynamic analysis|
16340082|NCT00347737|Drug|teriparatide|Teriparatide
16340083|NCT00347724|Drug|Tramadol HCl ER|
16340084|NCT00347711|Drug|Intravitreal injection|
16340085|NCT00347698|Drug|intravitreal injection of bevacizumab|
16340086|NCT00347698|Procedure|panretinal photocoagulation|
16340087|NCT00347685|Drug|tramadol ER|
16340088|NCT00347672|Biological|H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca)|Live, attenuated recombinant H5N1 (6-2) AA ca Recombinant (A/VietNam/1203/2004 x A/AnnArbor/6/60/ca) vaccine (one of three doses)
16340089|NCT00347659|Drug|BLVR System|Treatment is administered in a single treatment session.
16340090|NCT00347646|Drug|Plasmin|27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection
16340091|NCT00347620|Device|spectacles|
16340092|NCT00347620|Procedure|Cataract Surgery|
16340093|NCT00347607|Behavioral|community surveillance and re-treatment|
16340094|NCT00347594|Device|Next Generation Diagnostic Instrument (NGDI)|Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
16340095|NCT00347594|Device|Zyoptix Diagnostic Workstation (ZDW)|Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
16340096|NCT00347581|Procedure|Base-in prism glasses for reading|
16340097|NCT00347581|Procedure|Placebo reading glasses|
16340098|NCT00347568|Device|TX-plore|PI has terminated at institution and there is no one available to report.
16340099|NCT00347555|Biological|Aluminum Phosphate|1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.
16340100|NCT00347555|Drug|Placebo|0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).
16340101|NCT00347555|Biological|EBA-175 RII-NG Malaria Vaccine|White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.
16340102|NCT00347542|Drug|Vitamin D|
16340103|NCT00347529|Biological|pPML7789 with and without pPJV2012 administered by PMED|
16340104|NCT00347516|Procedure|IOL calculation formula|
16340105|NCT00347503|Drug|ketorolac 0.4%, bromfenac 0.09%|
16340106|NCT00347490|Drug|Enoxaparine|
16340107|NCT00347477|Drug|HyperHAES vs. RA-solution/NaCl|
16340108|NCT00347438|Drug|Capecitabine|Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
16340109|NCT00347425|Drug|Aripiprazole|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
16340110|NCT00347425|Drug|Olanzapine|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
16340111|NCT00347425|Drug|Risperidone|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
16340112|NCT00347425|Drug|Quetiapine|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
16340113|NCT00347425|Drug|Ziprasidone|Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
16340114|NCT00347425|Drug|Aripiprazole|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
16340115|NCT00347425|Drug|Olanzapine|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
16340116|NCT00347425|Drug|Risperidone|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
16340117|NCT00347425|Drug|Quetiapine|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
16340118|NCT00347425|Drug|Ziprasidone|Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
16340119|NCT00347412|Drug|Paclitaxel and Carboplatin|"Paclitaxel and carboplatin: (All randomized patients)
~All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first.
~The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel,as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing."
16340120|NCT00347412|Drug|NOV-002 Injection in combination with Carboplatin vs. Paclitaxel and Carboplatin|"NOV-002: (Group A only)
~Two 60mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one
~For each nominal 21-day paclitaxel and carboplatin cycle:
~60mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin
~followed by 60mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins.
~Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first."
16340121|NCT00347399|Drug|bevacizumab intravitreal injection|
16340122|NCT00347399|Procedure|verteporfin photodynamic therapy|
16340313|NCT00345813|Dietary Supplement|soy isoflavones|Given orally
16340123|NCT00347386|Drug|Drug: Zinc (zinc sulphate)|Dissolvable tablet 10 mg. Once daily during the illness
16340124|NCT00347386|Drug|Placebo|Placebo tablet, once daily
16340125|NCT00347373|Drug|Tonalin Conjugated linoleic acid (dietary supplement)|
16340126|NCT00347360|Drug|lisinopril|
16340127|NCT00347360|Drug|carvedilol controlled release formulation|
16340128|NCT00347334|Behavioral|infant home positioning|
16340129|NCT00347321|Procedure|Dilatational Percutaneous tracheostomy|Dilatational Percutaneous tracheostomy
16340130|NCT00347308|Behavioral|Eyebrow Position|Photography of brow positions
16340131|NCT00347295|Drug|Brotizolam|
16340132|NCT00347295|Drug|Estazolam|
16340133|NCT00347269|Behavioral|Cognitive-behavioral therapy|Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
16340134|NCT00347269|Drug|Psychotropic medication optimization|For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
16340135|NCT00347269|Behavioral|Treatment as Usual|Participants in the control group will receive standard treatment from their PCP.
16340136|NCT00347256|Drug|cisplatin|
16340137|NCT00347256|Procedure|targeted radiation therapy|
16340138|NCT00347256|Procedure|tumor resection|
16340139|NCT00347243|Procedure|phacoemulsification (cataract surgery)|
16340140|NCT00347230|Device|Intacs intracorneal ring insertion for the treatment of keratoconus|
16340141|NCT00347204|Drug|ketorolac (Acular LS)|
16340142|NCT00347204|Drug|Nepafenac (Nevanac)|
16340143|NCT00347178|Procedure|Laser Peripheral Iridotomy|
16340144|NCT00347165|Drug|bevacizumab intravitreal injection|
16340145|NCT00347152|Drug|Divalproex|Divalproex, 8-20% taper
16340146|NCT00347152|Drug|Divalproex|Divalproex, 8-20% taper
16340147|NCT00347139|Drug|GW642444 (25, 100 & 400 mcg/day)|25, 100 and 400mcg/dose
16340148|NCT00347139|Drug|Salmeterol 50mcg|Salmeterol 50mcg
16340149|NCT00347113|Drug|Albendazole and praziquantel|
16340150|NCT00347100|Drug|Insulin Glargine|Throughout study period
16340151|NCT00347100|Drug|Glyburide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
16340152|NCT00347100|Drug|Glyclazide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
16340153|NCT00347100|Drug|Glimiperide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
16340154|NCT00347100|Drug|Glipizide|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
16340155|NCT00347100|Drug|Metformin|Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
16340156|NCT00347087|Drug|Irbesartan|up-titration over 4 weeks to target dose 300 mg od
16340157|NCT00347061|Drug|afuzosin|
16340158|NCT00347048|Drug|tacrolimus|oral
16340159|NCT00347048|Drug|Placebo|oral
16340160|NCT00347035|Drug|brimonidine|
16340161|NCT00347022|Drug|Xenetix|300 mg of iodine/ml
16340162|NCT00347022|Drug|Visipaque|270 mg of iodine/ml
16340163|NCT00347009|Drug|adefovir dipivoxil|10mg once daily
16340164|NCT00346996|Drug|insulin levemir / aspart|for subcutaneous injection
16340165|NCT00346996|Drug|human insulin /insulin isophane|for subcutaneous injection
16340166|NCT00346983|Drug|Pegaptanib sodium|0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections
16340167|NCT00346983|Drug|Control|Sham injection, every 6 weeks, up to a total of 3 sham injections
16340168|NCT00346970|Drug|Extended-Release Niacin|Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d
16340169|NCT00346970|Drug|Placebo|Placebo tablets
16340170|NCT00346957|Drug|Anecortave acetate 30 mg|0.5ml administered onto the sclera once every six months for 24 months
16340171|NCT00346957|Drug|Anecortave Acetate 15 mg|0.5ml administered onto the sclera once every six months for 24 months
16340172|NCT00346957|Drug|Anecortave Acetate 3 mg|0.5ml administered onto the sclera once every six months for 24 months
16340173|NCT00346957|Other|Anecortave Acetate Vehicle|0.5ml administered onto the sclera once every six months for 24 months
16340174|NCT00346944|Procedure|Removal of dental amalgam restorations|Removal of dental amalgam restorations by patient's own dentist. Fillings will be replaced with e.g. resin based filling material, metalloceramic restorations, and ceramic materials. Rubber dam will be used during removal of amalgam restorations.
16340175|NCT00346931|Procedure|Phacoemulsification, implantation of intraocular lens|
16340176|NCT00346931|Procedure|Phacoemulsification, Implantation of IOL, trabeculotomy|
16340177|NCT00346918|Drug|Sirolimus|Standard plus Sirolimus
16340178|NCT00346918|Other|Standard|Standard
16340179|NCT00346905|Drug|Enteryx|
16340180|NCT00346892|Biological|Rotavirus (vaccine)|
16340181|NCT00346879|Drug|fondaparinux|Single 2.5 mg dose of fondaparinux or weight-based 0.03 mg/Kg dose of fondaparinux
16340182|NCT00346866|Drug|anecortave acetate|
16340183|NCT00346853|Drug|4-Methylpyrazole|15 mg/kg dose
16340184|NCT00346853|Other|saline|
16340185|NCT00346840|Drug|Misoprostol vaginal insert 25 mcg|One hydrogel polymer vaginal insert for up to 24h
16340186|NCT00346840|Drug|Misoprostol vaginal insert 50 mcg|One hydrogel polymer vaginal insert for up to 24h
16340187|NCT00346840|Drug|Misoprostol vaginal insert 100 mcg|One hydrogel polymer vaginal insert for up to 24h
16340188|NCT00346840|Drug|Misoprostol vaginal insert 200 mcg|One hydrogel polymer vaginal insert for up to 24h
16340189|NCT00346827|Drug|Apomorphine Nasal Powder|
16340190|NCT00346814|Drug|intravitreal injection|
16340191|NCT00346801|Drug|Celecoxib|100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).
16340192|NCT00346801|Drug|Cisplatin|25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8
16340193|NCT00346801|Drug|CPT-11|30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.
16340194|NCT00346801|Radiation|Concurrent Thoracic Radiation Therapy|63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.
16340195|NCT00346788|Procedure|Surgical approach for total knee arthroplasty|total knee arthroplasty surgery using minimally invasive surgery or standard technique.
16340196|NCT00346775|Drug|Beclomethasone dipropionate|Beclomethasone dipropionate
16340197|NCT00346775|Drug|Flunisolide|Flunisolide
16340198|NCT00346762|Behavioral|Education|HIV prevention education and risk reduction counselig
16340199|NCT00346749|Drug|Salmeterol|
16340200|NCT00346749|Drug|Fluticasone Propionate/Salmeterol Combination Product|
16340201|NCT00346736|Procedure|Acupuncture (Procedure)|
16340202|NCT00346723|Biological|Influvac® subunit influenza vaccine for i.m./deep s.c.injection|
16340203|NCT00346697|Drug|Omega-3 fatty acid administration|LOVAZA 1 gram capsules, 4 capsules daily
16340204|NCT00346697|Drug|Placebo|Corn-oil placebo
16340205|NCT00346684|Drug|Rituximab|
16340206|NCT00346671|Other|Rest|30 min supine rest
16340207|NCT00346671|Other|Sham|30 min session with Sham practitioner
16340208|NCT00346671|Other|Reiki|30 min session with Reiki practitioner
16340209|NCT00346658|Drug|magnesium|
16340210|NCT00346645|Drug|Bortezomid (VELCADE®)|
16340211|NCT00346632|Drug|KW-2449|Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).
16340212|NCT00346619|Drug|Nelfinavir|
16340213|NCT00346606|Drug|Denosin® and Xyzal®|
16340214|NCT00346593|Device|Silicone hydrogel contact lens|
16340215|NCT00346580|Drug|Nelfinavir|
16340216|NCT00346567|Drug|Zidovudine and Lamivudine (Combivir)|
16340217|NCT00346567|Drug|Emtricitabine and Tenofovir (Truvada)|
16340218|NCT00346528|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
16340219|NCT00346528|Drug|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
16340220|NCT00346515|Device|FiberNet Emboli Protection System|
16340221|NCT00346502|Drug|20% betulinic acid ointment|
16340222|NCT00346502|Drug|BA|20% Betulinic Acid Ointment
16340223|NCT00346489|Drug|5-fluorouracil|
16340224|NCT00346489|Drug|Mitomycin C|
16340225|NCT00346463|Drug|Allopurinol|
16340226|NCT00346450|Procedure|Cultivated conjunctival transplantation|
16340227|NCT00346437|Genetic|Ad5FGF-4 vs. Placebo|Intracoronary infusion
16340228|NCT00346424|Drug|Alfimeprase|
16340229|NCT00346398|Biological|Oral mucosal immunoprophylaxis (OMIP)|OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.
16340230|NCT00346398|Biological|Placebo|The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
16340231|NCT00346385|Drug|BB-10901|dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
16340232|NCT00346359|Biological|anti-thymocyte globulin|
16340233|NCT00346359|Drug|busulfan|
16340234|NCT00346359|Drug|fludarabine phosphate|
16340235|NCT00346359|Drug|methotrexate|
16340236|NCT00346359|Drug|tacrolimus|
16340237|NCT00346359|Procedure|allogeneic hematopoietic stem cell transplantation|
16340238|NCT00346359|Procedure|peripheral blood stem cell transplantation|
16340239|NCT00346333|Drug|Lutein|12mg/d
16340240|NCT00346333|Dietary Supplement|Cornstarch control|Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
16340241|NCT00346320|Radiation|3-dimensional conformal radiation therapy|3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
16340242|NCT00346294|Drug|Etanercept|Intervention type was to study the drug delivery method.
16340243|NCT00346281|Device|32P BioSilicon|
16340244|NCT00346268|Drug|Morphine, Parecoxib|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
16340245|NCT00346268|Drug|Morphine, Placebo|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
16340246|NCT00346255|Drug|BB-10901|dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
16340247|NCT00346242|Drug|Zoledronic Acid|
16340248|NCT00346229|Biological|filgrastim|
16340249|NCT00346229|Biological|pegfilgrastim|
16340250|NCT00346229|Drug|lyso-thermosensitive liposomal doxorubicin(Thermodox)|
16340251|NCT00346229|Procedure|hyperthermia treatment|
16340252|NCT00346216|Drug|celecoxib|100 to 200 mg twice daily, taken by mouth
16340253|NCT00346216|Drug|Ibuprofen|ibuprofen 600 mg to 800 mg three times daily, taken by mouth
16340254|NCT00346216|Drug|Naproxen|naproxen 375mg to 500 mg twice daily, taken by mouth
16340255|NCT00346190|Drug|Alendronate|
16340256|NCT00346177|Biological|Autologous Stem Cells|Intramyocardial injections
16340257|NCT00346164|Drug|doxorubicin hydrochloride|Given IV
16340258|NCT00346164|Other|clinical observation|Patients undergo observation
16340259|NCT00346164|Procedure|therapeutic conventional surgery|Patients undergo surgery
16340260|NCT00346164|Radiation|3-dimensional conformal radiation therapy|Patients undergo radiotherapy
16340261|NCT00346164|Drug|ifosfamide|Given IV
16340262|NCT00346151|Drug|Belatacept|10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
16340263|NCT00346151|Drug|Sirolimus|4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
16340264|NCT00346151|Drug|Anti-thymocyte globulin|1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
16340314|NCT00345813|Dietary Supplement|soy protein isolate|Given orally
16340265|NCT00346151|Drug|methylprednisolone|500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
16340266|NCT00346138|Procedure|Corneal transplantation|
16340267|NCT00346125|Biological|pegfilgrastim|will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
16340268|NCT00346125|Drug|doxorubicin hydrochloride|65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
16340269|NCT00346125|Drug|ifosfamide|9 g/m^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m^2 by continuous IV infusion over 7 days beginning on day 1
16340270|NCT00346125|Drug|pegylated liposomal doxorubicin hydrochloride|45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
16340271|NCT00346125|Procedure|conventional surgery|The surgical procedure will be decided by the treating physician and independent of study participation
16340272|NCT00346125|Radiation|fludeoxyglucose F 18|FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
16340273|NCT00346112|Procedure|psycho-educational|
16340274|NCT00346099|Drug|Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by|
16340275|NCT00346099|Drug|Panitumumab with capecitabine and radiation|
16340276|NCT00346086|Drug|AIC (Amb a 1 Immunostimulatory Conjugate)|
16340277|NCT00346073|Biological|Boostrix™|Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
16340278|NCT00346073|Biological|ADACEL®|Sanofi Pasteur
16340279|NCT00346060|Device|Retinal transplantation instrument|
16340280|NCT00346060|Device|Fetal tissue.|
16340281|NCT00346047|Drug|Placebo|Corresponding placebo is applied for 12weeks
16340282|NCT00346047|Drug|Buprenorphine Transdermal System|Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
16340283|NCT00346034|Drug|Pregabalin|150 to 600mg/day
16340284|NCT00346021|Behavioral|Increasing hat use|Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats
16340285|NCT00346008|Genetic|mutation analysis|
16340286|NCT00346008|Other|high performance liquid chromatography|
16340287|NCT00346008|Other|laboratory biomarker analysis|
16340288|NCT00346008|Other|questionnaire administration|
16340289|NCT00345982|Drug|Serdolect|16 mg, 12 weeks
16340290|NCT00345982|Drug|placebo|placebo
16340291|NCT00345969|Drug|Transdermal Testosterone gel (1%)|Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.
16340292|NCT00345969|Behavioral|Supervised exercise training|Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.
16340293|NCT00345956|Biological|Human rotavirus liquid vaccine|
16340294|NCT00345943|Other|MRI|Magnetic Resonance Imaging scans
16340295|NCT00345943|Behavioral|Neuropsychological Testing|Neuropsychological tests
16340296|NCT00345917|Device|Retinal transplantation instrument|
16340297|NCT00345917|Device|Fetal tissue.|
16340298|NCT00345904|Biological|Fluarix|
16340299|NCT00345891|Behavioral|Coping-focused counseling telephone calls|
16340300|NCT00345878|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16340301|NCT00345878|Biological|HPV-16/18 L1 VLP AS04 (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16340302|NCT00345865|Drug|carmustine|Day -6, 300 mg/m^2 over 2 hour
16340303|NCT00345865|Drug|cyclophosphamide|"NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days.
~HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days.
~Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing."
16340304|NCT00345865|Drug|etoposide|"NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2.
~HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4."
16340305|NCT00345865|Procedure|peripheral blood stem cell transplantation|Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.
16340306|NCT00345865|Radiation|irradiation therapy|"Patients undergo total body irradiation (TBI) twice daily on days -4 to -1.
~> 1000 cGy to whole lung, kidney, or abdominal bath.
~> 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes.
~> 3600 cGy to whole brain."
16340307|NCT00345865|Biological|G-CSF|"Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size.
~Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days.
~If ANC falls <1000/μL, restart G-CSF."
16340308|NCT00345865|Drug|Cytarabine|100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.
16340309|NCT00345852|Procedure|Fetoscopic Selective Laser Photocoagulation|
16340310|NCT00345839|Drug|Cinacalcet|Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
16340311|NCT00345839|Drug|Placebo|Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
16340312|NCT00345826|Drug|dasatinib|
16340315|NCT00345813|Other|placebo|Given orally
16340316|NCT00345800|Drug|Sodium Oxybate (Xyrem)|Active Substance: Sodium Oxybate Pharmaceutical form: Oral Solution Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks Route of administration: Oral
16340317|NCT00345787|Drug|Placebo|Corresponding placebo is applied for 12weeks
16340318|NCT00345787|Drug|Buprenorphine Transdermal System|Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks
16340319|NCT00345774|Drug|PRX-08066|
16340320|NCT00345761|Drug|Bevacizumab|7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
16340321|NCT00345761|Drug|Oxaliplatin|130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
16340322|NCT00345761|Drug|Capecitabine|2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
16340323|NCT00345748|Drug|Abatacept|Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
16340324|NCT00345748|Drug|Placebo|Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
16340325|NCT00345735|Drug|Fentanyl|
16340326|NCT00345722|Procedure|strawberry dietary intervention|
16340327|NCT00345709|Behavioral|Questionnaire|65 page questionnaire that contains questions about your ovarian cancer diagnosis, gynecologic history, family history, general medical history, and health risk factors.
16340328|NCT00345696|Drug|Bevacizumab|5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
16340329|NCT00345696|Drug|Capecitabine|600 mg/m2, orally, every 12 hours, continuous.
16340330|NCT00345696|Drug|Oxaliplatine|85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
16340331|NCT00345683|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)|Booster dose by intramuscular injection
16340332|NCT00345683|Biological|PedvaxHIB|Booster dose by intramuscular injection
16340333|NCT00345683|Biological|Prevnar|Booster dose by intramuscular injection
16340334|NCT00345683|Biological|M-M-R II|Single dose by subcutaneous injection
16340335|NCT00345683|Biological|Varivax|Single dose by subcutaneous injection
16340336|NCT00345670|Biological|MEDI-534|10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
16340337|NCT00345670|Biological|MEDI-534|10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
16340338|NCT00345670|Biological|MEDI-534|10:6 TCID50 of MEDI-534; intranasal spray
16340339|NCT00345657|Drug|Niacin Extended Release/Lovastatin|
16340340|NCT00345644|Drug|risedronate|risedronate sodium 35 mg tablets (once a week dose)
16340341|NCT00345644|Drug|risedronate placebo|placebo for risedronate tablets (once a week dose)
16340342|NCT00345631|Other|Manual Compression|Manual compression
16340343|NCT00345631|Device|Vascular Closure Device|Investigational vascular closure device
16340344|NCT00345618|Drug|Idrabiotaparinux sodium|"0.5 mL pre-filled syringe for 3.0 mg
~Subcutaneous injection"
16340345|NCT00345618|Drug|Warfarin|"Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
~Oral administration"
16340346|NCT00345618|Drug|Placebo (for idrabiotaparinux sodium)|"0.5 mL pre-filled syringe
~Subcutaneous injection"
16340347|NCT00345618|Drug|Avidin|"100 mg in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
16340348|NCT00345618|Drug|Placebo (for warfarin)|"Warfarin matching capsules
~Oral administration"
16340349|NCT00345618|Drug|Enoxaparin|"Prefilled syringes as locally registered
~Subcutaneous injection"
16340350|NCT00345605|Drug|Sodium Phenylbutyrate|None will be administered during the washout period; 500 mg/kg/day or 10 grams/m2 will be administered during the first one week treatment period in addition to arginine
16340351|NCT00345605|Drug|Arginine|Standard therapeutic dose of 500 mg/kg/day or 10 grams/2 will be administered during the washout periods, during the first one week treatment period when receiving arginine plus Buphenyl, 100 mg/kg/day or 2 grams/m2 will be administered, during the second treatment week, when receiving arginine alone, 500 mg/kg/day or 10 grams/m2 will be administered
16340352|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
16340353|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|In hospital application of anti arrhythmic therapies via the device
16340354|NCT00345592|Device|Dual (atrial and ventricular) implantable defibrillator|Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
16340355|NCT00345579|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014|3-dose intramuscular injection
16340356|NCT00345579|Biological|ActHIB|3-dose intramuscular injection
16340357|NCT00345579|Biological|Pediarix/Infanrix Penta|3-dose intramuscular injection
16340358|NCT00345566|Procedure|Nutrition composition|
16340359|NCT00345540|Drug|NOV-002|60 mg / mL / day / 20-23 Days
16340360|NCT00345540|Drug|Carboplatin|AUC 5 following IV bolus administration of NOV-002
16340361|NCT00345527|Behavioral|Emotion and Behaviour Regulation Treatment (EBRT)|
16340362|NCT00345527|Behavioral|Cognitive Behavioural Therapy|
16340363|NCT00345514|Behavioral|Behavioral Intervention Arm|The arm emphasized individual provider behavior (interactive CME, feedback at the provider, clinic and program levels, expert modeling, academic detailing and opinion leaders)
16340364|NCT00345514|Behavioral|Organizational Interventions Arm|Leadership, team building, benchmarking at the clinic and program level
16340365|NCT00345501|Drug|Iloprost|Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end
16340366|NCT00345501|Drug|Placebo|Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
16340367|NCT00345462|Biological|Trivalent virosomal influenza vaccine|
16340368|NCT00345449|Behavioral|Decision Aid|
16340369|NCT00345410|Drug|AVE1625 B|
16340370|NCT00345397|Device|Percutaneous endoscopic colostomy (PEC) tube|PEC placement for antegrade enemas uses commercially available PEG tubes
16340371|NCT00345384|Drug|Dexmedetomidine|Dexmedetomidine titrated over 24 hours
16340372|NCT00345384|Other|Placebo (Normal Saline)|
16340373|NCT00345371|Drug|Topiramate|
16353452|NCT00237510|Drug|terazosin|
16340374|NCT00345371|Drug|Placebo Oral Tablet|
16340375|NCT00345358|Biological|Synflorix|1, 2, 3 or 4 Intramuscular injections, depending on age group
16340376|NCT00345358|Biological|Infanrix IPV/Hib|4 intramuscular injections
16340377|NCT00345345|Biological|Alemtuzumab (Campath)|Alemtuzumab (Campath) will be administered at 10 mg/dose IV for 10 days as an infusion over 2 hours.
16340378|NCT00345332|Drug|Botox|Injected
16340379|NCT00345332|Drug|Placebo|Injected
16340380|NCT00345319|Biological|rabies vaccine|Administration of PCECV according to ESSEN regimen
16340381|NCT00345306|Drug|Comparison between two different progesterone administration|
16340382|NCT00345293|Biological|autologous dendritic cell vaccine (DC/PC3)|ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
16340383|NCT00345280|Procedure|impression cytology, obtain the tear fluid|Vitamin A
16340384|NCT00345267|Device|Integrated Care Pathway|
16340385|NCT00345254|Procedure|severing cord|The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
16340386|NCT00345241|Drug|Systane Ocular Drops (OTC)|
16340387|NCT00345241|Drug|Placebo - Saline Drops|
16340388|NCT00345215|Behavioral|High Sodium Diet|250-350 mmol
16340389|NCT00345215|Behavioral|Low Sodium Diet|25-35 mmol
16340390|NCT00345202|Drug|HMG-CoA reductase inhibition (atorvastatin)|
16340391|NCT00345189|Drug|CNF2024|"CNF2024 capsules administered orally following 2 schedules:
~starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or
~starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).
~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment."
16340392|NCT00345176|Dietary Supplement|Lutein/zeaxanthin|10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
16340393|NCT00345176|Dietary Supplement|DHA/EPA|Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
16340394|NCT00345176|Drug|Lutein/zeaxanthin and DHA/EPA|10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
16340395|NCT00345163|Drug|bevacizumab|Intravenous repeating dose
16340396|NCT00345163|Drug|irinotecan|Intravenous repeating dose
16340397|NCT00345150|Drug|Ng-monomethyl-L-arginine (drug)|
16340398|NCT00345137|Drug|Ng-monomethyl-L-arginine (drug)|
16340399|NCT00345124|Behavioral|high sodium diet|250-350 mmol
16340400|NCT00345124|Behavioral|Low Sodium Diet|25-35 mmol
16340401|NCT00345111|Procedure|Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.|
16340402|NCT00345098|Drug|SR58611A|
16340403|NCT00345085|Device|Wavefront and Contrast Sensitivity|
16340404|NCT00345072|Device|Web-based decision aid system|
16340405|NCT00345059|Drug|docetaxel|
16340406|NCT00345059|Drug|vinorelbine|
16340407|NCT00345059|Drug|gemcitabine|
16340408|NCT00345059|Drug|capecitabine|
16340409|NCT00345046|Drug|Pred Forte|Four drops daily decreasing to once daily over four weeks.
16340410|NCT00345046|Drug|EconoPred Plus|Prednisolone Acetate four times daily decreasing to once daily over four weeks.
16340411|NCT00345046|Drug|Prednisolone Acetate|Dosed four times daily decreasing to once daily over four weeks.
16340412|NCT00345033|Drug|Aripiprazole|15-mg dose once a day for 8 weeks
16340413|NCT00345033|Drug|Placebo|1 tablet placebo dose once a day for 8 weeks
16340414|NCT00345020|Procedure|Deep Lamellar Endothelial Keratoplasty: Small Incision Technique|
16340415|NCT00345007|Procedure|Scleral buckling|
16340416|NCT00344994|Drug|pramipexole|PO, 0.25mg, 0.50mg, or 0.75mg QHS
16340417|NCT00344981|Drug|Tenofovir|Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir.
16340418|NCT00344981|Drug|Hydroxyurea|Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir. Volunteers will continue on this regimen for 48 weeks. Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study. If a patient's viral load reaches >400 copies/ml on 3 consecutive measurements over a 6 week period, they will be terminated from the study and started back on their HAART.
16340419|NCT00344968|Drug|fluocinolone acetonide|0.5 mg fluocinolone acetonide intravitreal insert
16340420|NCT00344968|Drug|Fluocinolone Acetonide|0.2 mg fluocinolone acetonide intravitreal insert
16340421|NCT00344968|Procedure|Standard of care laser photocoagulation|Laser photocoagulation
16340422|NCT00344955|Drug|HMG-CoA reductase inhibition (atorvastatin)|
16340423|NCT00344942|Drug|triamcinolone acetonide|220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
16340424|NCT00344942|Drug|placebo|a double spray into each nostril once daily
16340425|NCT00344916|Drug|Ng-monomethyl-L-arginine (drug)|
16340426|NCT00344890|Procedure|Anterior Cervical Discectomy and Fusion|1,2,3,or 4 level surgery
16340427|NCT00344864|Device|LADARWave|
16340428|NCT00344851|Drug|metformin, exenatide or combined (metformin & exenatide )|
16340429|NCT00344838|Device|Comparison of LADAR CustomLasik and VISX Wavefront System custom laser ablation devices|
16340475|NCT00344318|Biological|Hiberix|Reconstituted with Tritanrix before injection
16340476|NCT00344318|Biological|Polio Sabin.|3 oral doses.
16340477|NCT00344318|Biological|Poliorix.|3 intramuscular injections
16340537|NCT00343798|Procedure|biopsy|Optional correlative studies
16340538|NCT00343798|Other|immunologic technique|Correlative studies
16354326|NCT00229333|Drug|Escitalopram|
16340430|NCT00344825|Drug|Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)|"Descriptive statistical methods applied for the whole study cohort and for subgroups according to QoL and the correlation of the following parameters: Age, Sex, Stage of disease, Time from first B-CLL diagnosis, number of previous B-CLL treatments, Reason of starting of the new B-CLL treatment (progression disease, relapse, no-response to the previous treatment, previous treatment toxicity), Therapeutic Regimen (Day Hospital, Hospital Admission, etc.), Type of Centre, B-CLL treatment lasting, Response to B-CLL treatment.
~QoL at baseline, Change in QoL over time evaluated using an analysis of Variance."
16340431|NCT00344812|Drug|LAAM. buprenorphine and methadone|
16340432|NCT00344786|Drug|CNF2024 (BIIB021)|"Dose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period.
~Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment."
16340433|NCT00344773|Drug|Gefitinib|250mg tablet oral tablet once daily
16340434|NCT00344760|Drug|Enfuvirtide|subcutaneously twice a day
16340435|NCT00344760|Drug|Efavirenz, lamivudine, and tenofovir|Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
16340436|NCT00344747|Behavioral|dietary, behavioral, physical activity|
16340437|NCT00344734|Drug|Ng-monomethyl-L-arginine (drug)|
16340438|NCT00344721|Dietary Supplement|Omega-3 fatty acid supplement|Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.
16340439|NCT00344721|Dietary Supplement|Placebo|Participants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months.
16340440|NCT00344708|Procedure|Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells|
16340441|NCT00344695|Drug|bupropion SR|
16340442|NCT00344682|Drug|memantine|memantine 5mg - 20mg PO daily
16340443|NCT00344682|Drug|Placebo|5mg - 20mg PO daily over 8 weeks
16340444|NCT00344669|Drug|Albendazole 400 mg, given 6 monthly|
16340445|NCT00344643|Device|Silicone Hydrogel Soft Contact Lenses|
16340446|NCT00344630|Device|TAXUS Stent and Cypher Stent|
16340447|NCT00344617|Drug|Bevacizumab (tradename: Avastin)|
16340448|NCT00344604|Behavioral|Role of psychosocial and quality of life parameters prior to and following LASIK.|
16340449|NCT00344591|Behavioral|Structured Ecosystems Therapy (SET)|
16340450|NCT00344591|Behavioral|Individually tailored intervention|
16340451|NCT00344578|Device|Restor IOL|
16340452|NCT00344565|Drug|Modafinil|During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
16340453|NCT00344565|Behavioral|Cognitive Behavioral Therapy--Relapse Prevention|Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
16340454|NCT00344552|Drug|Paclitaxel|Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over
16340455|NCT00344539|Biological|AMA1-C1/Alhydrogel®|AMA1-C1/Alhydrogel malaria vaccine, cloudy suspension, 0.5 mL dose containing up to equivalent of 377 mcg of aluminum as Alhydrogel® (800 mcg of aluminum hydroxide gel per dose) onto which 20 mcg or 80 mcg of recombinant AMA1-C1 is bound. Dosages: 20 mcg and 80 mcg administered via the deltoid muscle by IM injection
16340456|NCT00344539|Biological|CPG 7909 Oligodeoxynucleotide (VaxImmune®)|CPG 7909 is an investigational agent and is supplied in sterile vials at 10mg/mL in phosphate buffered saline for intramuscular administration. Dosage 500 mcg.
16340457|NCT00344526|Drug|Melphalan|
16340458|NCT00344526|Drug|Dexamethasone|
16340459|NCT00344526|Procedure|Autologous stem cell transplantation|
16340460|NCT00344513|Drug|Beta-blockers including Carvedilol|
16340461|NCT00344513|Drug|ACE inhibitors|
16340462|NCT00344500|Behavioral|Behavioral Weight Loss Program|"Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
~Be given a 7% weight loss goal
~Be assisted in obtaining a 500 calorie reduction per day
~Exercise for at least 30 min/day, at least 5 days a week
~Maintain weekly food and exercise diaries
~Be quizzed on their knowledge of healthy eating habits and nutrition"
16340464|NCT00344474|Behavioral|PRE-Venture: Personality Risk Education|Motivational and Cognitive-Behavioural interventions targeting four personality risk factors for substance misuse. Two, 90-minute group sessions conducted at school with personality-matched peers and trained psychologists/councellors and co-facilitators.
16340465|NCT00344461|Drug|Nevirapine, FTC, and Tenofovir|One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
16340466|NCT00344448|Drug|Raptiva|During the first phase of the study, subjects are randomized in a double blind fashion to receive weekly subcutaneous injections of efalizumab (Raptiva) or placebo (weeks 0-12). The second 12 weeks long phase is open label with all subjects receiving weekly subcutaneous injections of efalizumab.
16340467|NCT00344422|Drug|Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)|
16340468|NCT00344409|Drug|darbepoetin alfa|
16340469|NCT00344383|Drug|Norgestimate/Ethinyl Estradiol tablet|
16340470|NCT00344370|Drug|Pitavastatin|Pitavastatin 4 mg QD
16340471|NCT00344370|Drug|Atorvastatin|Atorvastatin 40 mg
16340472|NCT00344318|Biological|Pneumococcal conjugate vaccine GSK1024850A|3 Intramuscular injections.
16340473|NCT00344318|Biological|Prevenar|3 Intramuscular injections
16340474|NCT00344318|Biological|Tritanrix-HepB|3 Intramuscular injections
16340478|NCT00344305|Biological|Trivalent influenza virus vaccine live, intranasal|A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
16340479|NCT00344253|Drug|Interferon beta|
16340480|NCT00344253|Drug|Methotrexate|
16340481|NCT00344240|Behavioral|Functional circuit training with lifestyle behavior|
16340482|NCT00344227|Drug|Lucentis (Ranibizumab)|
16340483|NCT00344214|Behavioral|Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program|This condition is a Theory-Based Counseling Program. The program will involve nine 90-minute face-to-face counseling sessions that use CBT and strategies associated with social cognitive theory. The theory addresses three treatment domains, including mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices.
16340484|NCT00344214|Behavioral|Standard care|Standard care involves nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT 1 (CDC, Atlanta) that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH).
16340485|NCT00344201|Device|Tisseel fibrin adhesive|Intraoperative application to scleral bed and graft
16340486|NCT00344175|Drug|pitavastatin|
16340487|NCT00344175|Drug|simvastatin|
16340488|NCT00344149|Drug|Rituximab (Mabthera)|I.V infusion of Rituximab 375 mg/m2 per week for 4 weeks
16340489|NCT00344123|Drug|Tipranavir/Ritonavir|"On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
~On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r."
16340490|NCT00344123|Drug|Rosuvastatin|"On Day 1, subjects will receive a single 10 mg dose of rosuvastatin. Beginning on Day 3, subjects will receive a combination of TPV 500mg/RTV 200 mg twice daily for 11 days (Days 3-13).
~On Day 12, subjects will receive a single 10 mg dose of rosuvastatin co-administered with TPV/r.."
16340491|NCT00344110|Drug|Aliskiren|
16340492|NCT00344097|Procedure|Soy protein|
16340493|NCT00344058|Drug|abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)|
16340494|NCT00344045|Drug|Paracetamol|IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
16340495|NCT00344045|Drug|Placebo|IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
16340496|NCT00344032|Biological|Placebo|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16340497|NCT00344032|Biological|HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16340498|NCT00344019|Drug|Placebo Oral Tablet|placebo pre-PCI for ACS
16340499|NCT00344019|Drug|Atorvastatin 80mg|atorvastatin 80 mg pre-angio/PCI
16340500|NCT00344019|Other|Screening|Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
16340501|NCT00344006|Drug|chlorproguanil-dapsone-artesunate|
16340502|NCT00344006|Drug|artemether-lumefantrine|
16340503|NCT00343993|Device|noninvasive positive pressure ventilation|
16340504|NCT00343980|Drug|rosiglitazone|Tablets, 4 mg once or twice a day.
16340505|NCT00343980|Drug|inhaled human insulin|Treat-to-target dose titration scheme, pre-prandial, inhalation.
16340506|NCT00343980|Drug|glimepiride|Tablets, 4 mg/day.
16340507|NCT00343954|Drug|L-citrulline tablets, 1000 mg|
16340508|NCT00343941|Drug|Tucaresol tablets 25 mg|
16340509|NCT00343928|Other|Branched-chain amino acids|Participants will spend approximately 2 weeks in each phase over a 9-week period, during which they will receive an amino acid mixture and the placebo control condition.
16340510|NCT00343915|Biological|Engerix™-B (thiomersal-free) 20µg|In the primary study: 2 deep intramuscular injections (Months 0, & 6)
16340511|NCT00343915|Biological|10 μg Engerix™-B (preservative-free)|In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
16340512|NCT00343915|Biological|placebo|In the primary study: 1 deep intramuscular injection (month 1)
16340513|NCT00343902|Drug|Crataegus Special Extract WS 1442|
16340514|NCT00343889|Biological|DTaP-HB-PRP~T vaccine + OPV|0.5 mL, Intramuscular
16340515|NCT00343889|Biological|Tritanrix-HepB/Hib™ + OPV vaccine|0.5 mL, Intramuscular
16340516|NCT00343889|Biological|Oral Polio Vaccine|Oral co-administered with study vaccine
16340517|NCT00343876|Drug|aspirin|
16340518|NCT00343876|Drug|clopidogrel|
16340519|NCT00343863|Drug|palonosetron hydrochloride|Given IV
16340520|NCT00343863|Drug|cyclophosphamide|Given orally
16340521|NCT00343863|Drug|dexamethasone|Given orally or IV
16340522|NCT00343863|Drug|doxorubicin hydrochloride|Given IV
16340523|NCT00343863|Procedure|quality-of-life assessment|Ancillary studies
16340524|NCT00343863|Procedure|nausea and vomiting therapy|Given IV
16340525|NCT00343863|Procedure|management of therapy complications|Given IV
16340526|NCT00343863|Drug|ondansetron hydrochloride|Given IV
16340527|NCT00343863|Other|survey administration|Ancillary studies
16340528|NCT00343850|Drug|Asacol (mesalamine)|
16340529|NCT00343824|Procedure|aquacel AG hydrofiber versus acticoat burn dressing|Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
16340530|NCT00343811|Drug|Modafinil|
16340531|NCT00343798|Drug|cyclophosphamide|Given IV
16340532|NCT00343798|Drug|fludarabine phosphate|Given IV
16340533|NCT00343798|Drug|cyclosporine|Given IV
16340534|NCT00343798|Drug|mycophenolate mofetil|Given IV or PO
16340535|NCT00343798|Other|ex-vivo umbilical cord blood expansion|Undergo double-unit umbilical cord blood transplantation
16340536|NCT00343798|Procedure|double-unit umbilical cord blood transplantation|Undergo double-unit umbilical cord blood transplantation
16340539|NCT00343798|Other|diagnostic laboratory biomarker analysis|Correlative studies
16340540|NCT00343785|Drug|cyclophosphamide|Given IV
16340541|NCT00343785|Biological|anti-thymocyte globulin|Given IV
16340542|NCT00343785|Drug|cyclosporine|Given IV or PO
16340543|NCT00343785|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplantation
16340544|NCT00343785|Drug|methotrexate|Given IV
16340545|NCT00343785|Genetic|DNA analysis|Correlative studies
16340546|NCT00343785|Other|flow cytometry|Correlative studies
16340547|NCT00343785|Genetic|polymorphism analysis|Correlative studies
16340548|NCT00343785|Other|laboratory biomarker analysis|Correlative studies
16340549|NCT00343759|Drug|Lapatinib|Patients will take 14 days of Lapatinib prior to definitive surgery.
16340550|NCT00343733|Drug|OraVescent Fentanyl|
16340551|NCT00343720|Drug|VELCADE|
16340552|NCT00343720|Drug|Alimta|
16340553|NCT00343707|Drug|vestipitant|
16340554|NCT00343707|Drug|paroxetine|
16340555|NCT00343681|Biological|Inactivated influenza vaccine (split virion)|0.5 mL, Intramuscular
16340556|NCT00343668|Drug|S-1, irinotecan|S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1
16340557|NCT00343655|Drug|Atorvastatin|
16340558|NCT00343642|Drug|Active fructo-oligosaccharide|2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans
16340559|NCT00343642|Drug|Placebo fructo-oligosaccharide|2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans
16340560|NCT00343642|Dietary Supplement|Diet|A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily)
16340561|NCT00343629|Drug|sulindac|
16340562|NCT00343629|Other|pharmacological study|
16340563|NCT00343616|Procedure|cognitive assessment|Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
16340564|NCT00343616|Procedure|fatigue assessment and management|Fatigue will be evaluated using the Brief Fatigue Inventory.
16340565|NCT00343616|Procedure|psychologic distress|Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
16340566|NCT00343616|Procedure|quality-of-life assessment|Quality of life will be assessed using global linear analogue self-assessment (LASA) indicators for physical well-being, mood, coping effort (PACIS), perceived social support and subjective health estimation.
16340567|NCT00343590|Device|Whole Body Vibration machine|
16340568|NCT00343564|Drug|SB-743921|Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops.
16340569|NCT00343564|Drug|SB-743921|Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
16340570|NCT00343551|Drug|Aliskiren|
16340571|NCT00343525|Drug|bavituximab|
16340572|NCT00343512|Drug|docetaxel|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
16340573|NCT00343512|Genetic|protein expression analysis|protein expression analysis
16340574|NCT00343512|Other|laboratory biomarker analysis|laboratory biomarker analysis
16340575|NCT00343512|Procedure|biopsy|biopsy
16340576|NCT00343512|Procedure|conventional surgery|conventional surgery
16340577|NCT00343512|Procedure|neoadjuvant therapy|neoadjuvant therapy
16340578|NCT00343499|Drug|valsartan|
16340579|NCT00343486|Drug|Solabegron|
16340580|NCT00343460|Drug|APF530|Given subcutanously
16340581|NCT00343460|Drug|dexamethasone|Given IV and orally
16340582|NCT00343460|Drug|Palonosetron Hydrochloride|Given IV
16340583|NCT00343460|Other|placebo|Given subcutanously or IV
16340584|NCT00343447|Biological|autologous tumor cell vaccine|
16340585|NCT00343447|Biological|rituximab|
16340586|NCT00343447|Drug|cyclophosphamide|
16340587|NCT00343434|Behavioral|behavioral dietary intervention|
16340588|NCT00343434|Behavioral|exercise intervention|
16340589|NCT00343434|Dietary Supplement|soy isoflavones|
16340590|NCT00343434|Dietary Supplement|soy protein isolate|
16340591|NCT00343434|Other|counseling intervention|
16340592|NCT00343434|Other|educational intervention|
16340593|NCT00343434|Procedure|psychosocial assessment and care|
16340594|NCT00343434|Procedure|quality-of-life assessment|
16340595|NCT00343421|Biological|PEDIACEL® and Prevenar®|0.5 mL each, IM (opposite thigh)
16340596|NCT00343421|Biological|Infanrix®-IPV+Hib and Prevenar®|0.5 mL each, IM (opposite thigh)
16340597|NCT00343408|Drug|cediranib maleate|
16340598|NCT00343408|Drug|cisplatin|
16340599|NCT00343408|Drug|fluorouracil|
16340600|NCT00343408|Drug|gemcitabine hydrochloride|
16340601|NCT00343408|Drug|leucovorin calcium|
16340602|NCT00343408|Drug|oxaliplatin|
16340603|NCT00343395|Drug|AVANDAMET|2/500 mg
16340604|NCT00343382|Drug|pilocarpine hydrochloride|Given orally
16340605|NCT00343382|Other|placebo|Given orally
16340606|NCT00343369|Drug|asparaginase|
16340607|NCT00343369|Drug|cyclophosphamide|
16340608|NCT00343369|Drug|cytarabine|
16340609|NCT00343369|Drug|daunorubicin hydrochloride|
16340610|NCT00343369|Drug|dexamethasone|
16340611|NCT00343369|Drug|doxorubicin hydrochloride|
16340612|NCT00343369|Drug|mercaptopurine|
16340613|NCT00343369|Drug|methotrexate|
16340614|NCT00343369|Drug|pegaspargase|
16340615|NCT00343369|Drug|prednisolone|
16340616|NCT00343369|Drug|teniposide|
16340617|NCT00343369|Drug|thioguanine|
16340618|NCT00343369|Drug|vincristine sulfate|
16340619|NCT00343369|Radiation|radiation therapy|
16340620|NCT00343356|Drug|Trement|
16340621|NCT00343343|Device|NovoFine® needle 6 mm|
16340622|NCT00343343|Device|NovoFine® needle 4 mm|
16340623|NCT00343317|Drug|Intrapartum Cefoxitin (2g) vs. placebo|
16340624|NCT00343304|Device|Robot|
16340625|NCT00343304|Device|Ergometer|
16340626|NCT00343291|Biological|Cetuximab|Administered intravenously
16340627|NCT00343291|Biological|Bevacizumab|Administered intravenously
16340628|NCT00343291|Drug|Paclitaxel|Administered intravenously
16340629|NCT00343291|Drug|Carboplatin|Administered intravenously
16340630|NCT00343278|Drug|Valaciclovir Hydrochloride|
16340631|NCT00343265|Drug|Vaginal progesterone gel|Vaginal gel once daily
16340632|NCT00343265|Drug|Placebo gel|once daily
16340633|NCT00343252|Drug|teriparatide|20 ug/day, subcutaneous, 18 months
16340634|NCT00343252|Drug|risedronate|35 mg/once weekly, oral, 18 months
16340635|NCT00343252|Drug|placebo|once weekly, oral, 18 months
16340636|NCT00343252|Drug|placebo|daily, subcutaneous, 18 months
16340637|NCT00343239|Drug|Docetaxel|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 75 mg/m2"
16340638|NCT00343239|Drug|Cisplatin|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 75 mg/m2"
16340639|NCT00343239|Drug|Fluorouracil|"Formulation: infusion solution
~Route of administration: IV infusion on the first day of each 21-day cycle
~Dose regimen: 750 mg/m2/day for 5 days"
16340640|NCT00343226|Drug|Basiliximab|
16340641|NCT00343213|Procedure|colposcopy|
16340642|NCT00343200|Drug|Placebo|Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
16340643|NCT00343200|Drug|Viagra (sildenafil citrate)|Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
16340644|NCT00343187|Drug|ACZONE (dapsone) Gel, 5%|
16340645|NCT00343187|Drug|Vehicle Control|
16340646|NCT00343174|Drug|Ancrod|
16340647|NCT00343161|Drug|esomeprazole|
16340648|NCT00343161|Drug|Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)|
16340649|NCT00343148|Drug|AVI-4126 Injection (RESTEN-NG®)|
16340650|NCT00343135|Drug|amoxicillin/clavulanate potassium 1gm|amoxicillin/clavulanate potassium 1gm
16340651|NCT00343122|Procedure|echocardiography for intrapulmonary vasodilatation|
16340652|NCT00343109|Biological|HER-2/neu intracellular domain protein|Given ID
16340653|NCT00343109|Procedure|leukapheresis|Optional correlative studies
16340654|NCT00343109|Other|laboratory biomarker analysis|Correlative studies
16340655|NCT00343109|Biological|sargramostim|Given ID
16340656|NCT00343109|Other|immunologic technique|Correlative studies
16340657|NCT00343109|Biological|synthetic tumor-associated peptide vaccine therapy|Given ID
16340658|NCT00343096|Drug|Lorazepam|All doses 0.1mg/kg once, repeat after 10 minutes x1
16340659|NCT00343083|Drug|Erbitux, Paclitaxel & Carboplatin|"Paclitaxel, 40 mg/m2/week,
~1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose.
~Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose.
~Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9)"
16340660|NCT00343083|Radiation|Radiation|XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed
16340661|NCT00343070|Drug|Oral administration of escitalopram during 8 weeks|
16340662|NCT00343057|Other|Patients' questionnaire|
16340663|NCT00343044|Drug|Topotecan|Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
16340664|NCT00343044|Drug|Bevacizumab|bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
16340665|NCT00343005|Biological|AMA1-C1|
16340666|NCT00343005|Drug|AMA1-C1/alhydrogel Malaria Vaccine|
16340667|NCT00342940|Biological|influenza surface antigen inactivated vaccine|
16340668|NCT00342862|Drug|Amevive exposure|Observational
16340669|NCT00342849|Drug|Succimer|Succimer (2,3-meso-dimercaptosuccinic acid) is an orally active dithiol compound that is a relatively specific chelating agent for heavy metals, especially lead, arsenic and mercury. The drug undergoes limited absorption in the gastrointestinal tract and then is rapidly metabolized to mixed disulfides which are eliminated in the urine. Blood levels decline slowly with an apparent elimination half-life of about 48 hours in adults.
16340670|NCT00342849|Drug|Placebo|
16340671|NCT00342836|Procedure|Akt levels|
16340672|NCT00342706|Procedure|Community based intervention|
16340673|NCT00342628|Biological|Vi-rEPA conjugate vaccine for typhoid fever|Vi-rEPA contains a 25 ug/dose of Vi (Sanofi-Pasteur Lot 130) and rEPA in 0.2 N NaCl, 10 mM phosphate PH 7.2 and 0.01% thimerosal.
16340674|NCT00342628|Biological|Hib-TT|Hib-TT is Hemophilus influenzae type b-tetanus toxoid conjugate vaccine (ActHib, NDC#49281-545-05 Sanofi-Pasteur, France) in single-dose vials containing 10 ugof Hib CP conjugated to 24 ug of tetanus toxoid
16340675|NCT00342628|Biological|DTP|DTP, diphtheria, tetanus toxoid and pertussis vaccine were from the Ministry of Health, Vietnam for routine infant immunization
16340676|NCT00342563|Drug|mecamylamine|mecamylamine 10mg/day
16340677|NCT00342563|Drug|Placebo|Placebo
16340678|NCT00342381|Drug|3,4-diaminopyridine|Single dose 3,4 diaminopyridine
16340679|NCT00342381|Drug|Placebo|Single dose placebo treatment
16340680|NCT00342368|Procedure|CPAP delivered by an Helmet|continuous positive airway pressures delivered through an helmet
16340681|NCT00342355|Drug|Zidovudine|600 mg once daily
16340682|NCT00342355|Drug|Stavudine|40 mg once daily
16340683|NCT00342355|Drug|Didanosine|<60 kg/125 mg twice daily or >60kg/200 mg twice daily
16340684|NCT00342355|Drug|Lamivudine|300 mg once daily
16340685|NCT00342355|Drug|Efavirenz|600 mg once daily
16340686|NCT00342355|Drug|Lopinavir/Ritonavir|r/LPV 400mg/100mg twice daily
16340687|NCT00342316|Procedure|Reduced Intensity Conditioning Stem Cell Transplantation|"One of the following conditioning regimens:
~Busulphan (orally or IV), fludarabine
~Fludarabine, carmustine, melfalan
~Cyclophosphamide, fludarabine"
16340688|NCT00342134|Procedure|Stem Cell Transplanataion|
16340689|NCT00342108|Behavioral|cross-modal sensory stimulation|comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation
16340690|NCT00341640|Procedure|Blood testing|
16340691|NCT00341614|Behavioral|3-month Exercise Training and Diet Education|
16340692|NCT00341471|Procedure|Risk Behavior Prevention Intervention Program|
16340693|NCT00341445|Behavioral|Effect of Cockroach Allergen|
16340694|NCT00341432|Behavioral|Nicotine Replacement Therapy|
16340695|NCT00341354|Behavioral|Prolonged Mechanical Ventilation|
16340696|NCT00341328|Biological|Intradermal injection of Mycobacterium w|Mw Vaccine is given as intradermal administration. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
16340697|NCT00341250|Drug|AMA1-C1/Alhydrogel Malaria Vaccine|
16340698|NCT00341224|Behavioral|Group-mentoring intervention|Group mentoring used to teach social skills to middle school students
16340699|NCT00341055|Drug|Epoetin alfa|
16340700|NCT00340938|Procedure|Blood testing|
16340701|NCT00340834|Drug|Fingolimod 1.25 mg|"Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
~Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."
16340702|NCT00340834|Drug|Fingolimod 0.5 mg|"Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
~Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily."
16340703|NCT00340834|Drug|Interferon β-1a 30 µg|"Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
~Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."
16340704|NCT00340704|Drug|tamsulosin hydrochloride|oral
16340705|NCT00340691|Drug|Doxycycline|
16340706|NCT00340678|Drug|Losartan|Treatment with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
16340707|NCT00340678|Drug|Placebo|Treatment with placebo corresponding to each dose of losartan.
16340708|NCT00340613|Drug|glargine insulin|
16340709|NCT00340574|Drug|AMA1-C1/Alhydrogel + CpG 7909|
16340710|NCT00340483|Behavioral|Smoking cessation|
16340711|NCT00340470|Behavioral|Driver Education|
16340712|NCT00340431|Drug|MSP1(42)-FVO & MSP1(42)-3D7|
16340713|NCT00340379|Drug|Ziprasidone|Target dosage 120-160mg/day based on tolerance
16340714|NCT00340379|Drug|Sertraline|Target dosage 150-200mg/day based on tolerance.
16340715|NCT00340379|Drug|Haloperidol|Target dosage 6-8mg/day based on tolerance.
16340716|NCT00340327|Drug|IMA-638|
16340717|NCT00340314|Procedure|Circumferential Pulmonary Vein Ablation|
16340718|NCT00340314|Drug|Antiarrhythmic Drug Therapy|
16340719|NCT00340184|Drug|paclitaxel, carboplatin|
16340720|NCT00340106|Behavioral|Counseling|
16340721|NCT00340093|Behavioral|Managing Diabetes|
16340722|NCT00340080|Drug|Abacavir|
16340723|NCT00340054|Other|questionnaire administration|
16340724|NCT00340054|Procedure|study of high risk factors|
16340725|NCT00339872|Drug|IMA-638|
16340726|NCT00339833|Drug|Salsalate|The intervention was salsalate (3g/day) for 7 days.
16340727|NCT00339833|Drug|Placebo|Identical placebo for 7 days.
16340728|NCT00339768|Drug|Amoxicillin/omeprazole|To treat Helicobacter pylori infections. 2 week course of amoxicillin 1gm bid, omeprazole 20mg bid. This factorial trial also investigated a supplement of vitamin C, vitamin E and selenium and a garlic supplement.
16340729|NCT00339690|Other|MITE-T-FASTtest kit|The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.
16340730|NCT00339625|Other|low fat, high fiber, high fruit and vegetable eating plan|Participants were randomized to a low fat, high fiber, high fruit and vegetable (intervention arm) or their usual diet (control arm)
16340731|NCT00339586|Drug|Erlotinib|
16340732|NCT00339469|Dietary Supplement|LIFE|We are evaluating the effects of a legume enriched, low glycemic index, high fermentable fiber diet, on CRP, and C-peptide participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps. In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets. 65 male participants were recruited and randomized into four groups. A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas. In addition, potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation, including mRNA from exfoliated fecal colonocytes. To our knowledge this is the first controlled feeding study: 1. to examine the effects of legumes or a low GI diet on markers of inflammation
16340733|NCT00339456|Drug|HAART|
16340734|NCT00339417|Drug|Albendazole|
16340735|NCT00339417|Drug|Ivermectin|
16340736|NCT00339365|Behavioral|Promoting First Relationships Program|Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants.
16340737|NCT00339365|Behavioral|Early Education Support Program|EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training.
16340738|NCT00339196|Drug|5 azacytidine - VALPROIC acid- Retinoic acid|5 azacytidine - VALPROIC acid- Retinoic acid
16340739|NCT00339183|Drug|Panitumumab|Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.
16340740|NCT00339183|Drug|FOLFIRI|FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 racemate (or 200 mg/m^2 I-leucovorin), 5-FU bolus 400 mg/m^2, 5-FU infusion 2400 mg/m^2.
16340741|NCT00339170|Behavioral|Computer-Based Cognitive Enhancement Training Program|Participants in the cognitive enhancement training program will receive feedback on their cognitive strengths and weaknesses based on the outcomes of the baseline assessment. The training component will be comprised of 150 computer-based exercises that focus on improving memory, attention, and organizational skills. Participants will attend two weekly meetings: one will focus on providing feedback regarding goal-setting and problem-solving, and the other will focus on improving verbal skills and social information processing.
16340742|NCT00339170|Behavioral|Work Therapy Program|Participants in the work therapy program will attend two non-cognitive discussion groups per week.
16340743|NCT00339157|Drug|Anakinra|
16340744|NCT00339157|Biological|Pneumo23|
16340745|NCT00339144|Drug|Dasatinib|tablets, Oral, 100 mg, once daily for 4 weeks
16340746|NCT00339144|Drug|Dasatinib|tablets, Oral, 150 mg, once daily, 4 weeks
16340747|NCT00339144|Drug|Dasatinib|tablets, Oral, 200 mg, once daily for 4 weeks
16340748|NCT00339131|Drug|Ultratrace iobenguane I 131|
16340749|NCT00339118|Drug|doxorubicin, cytoxan|
16340750|NCT00339092|Behavioral|Modified Directly Observed Therapy|Treatment includes storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals. Participants in the MDOT program will report to the study site each morning for 3 months, Monday through Friday, to take their HIV medication and any other medications prescribed by their primary care doctors. At the end of 3 months, participants will no longer attend the study site for medication assistance. Participants will then attend Action Point, a county program that helps participants adhere to taking medication, for an additional 3 months.
16340751|NCT00339092|Behavioral|Standard Care|Participants assigned to standard care will report to the study site once a month for 9 months, but will not receive any assistance with taking HIV medications. Information about medication adherence, housing, income, use of health services, drug use, sexual practices, and mental health services will be collected at each visit.
16340752|NCT00339079|Drug|Fluoxetine|Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.
16340753|NCT00339079|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length.
16340754|NCT00339079|Other|Supportive Therapy|The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.
16340755|NCT00339079|Drug|Placebo|Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter.
16340756|NCT00339066|Drug|Sertraline|
16340757|NCT00339053|Drug|Immunonutrition ( Impact)|
16340758|NCT00339040|Biological|Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)|QHPV at week 0, 8, 24 and 96.
16340759|NCT00339040|Other|Placebo/QHPV|Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.
16340760|NCT00339014|Drug|Zonisamide CR and Bupropion SR|Zonisamide SR and Bupropion SR
16340761|NCT00339014|Other|Placebo|Identical placebo
16340762|NCT00339001|Drug|erythropoietin and early iron supplements|
16340763|NCT00338988|Drug|Capecitabine|1500 mg/m^2 PO twice daily x 14 days.
16340764|NCT00338988|Drug|Oxaliplatin|130 mg/m^2 IV over 2 hours on day 1 of cycle.
16340765|NCT00338975|Behavioral|Cognitive Behavioral Social Skills Training (CBSST)|There are 36 weekly group sessions, each session is 2 hours in length, with a half-hour break after the first hour. The intervention integrates CBT and SST techniques and neurocognitive compensatory aids. All participants are asked to identify a goal. The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. The CBT components are based on techniques developed for CBT in general and techniques developed specifically for patients with schizophrenia. Cognitive therapy is combined with role-play practice of communication skills and problem-solving training.
16340766|NCT00338975|Behavioral|Goal-focused supportive contact (GFSC)|"There are 36 weekly group sessions, each 2 hours in length, with a half-hour break after the first hour. GFSC has a number of specific goals and interventions, including providing a safe environment where the patient can discuss her/his feelings and concerns; to validate these feelings and concerns; and to provide support and guidance to the client so that she/he can make progress to solving problems or alleviating concerns and worries. Psychotic symptoms and cognition are not directly targeted. Therapists utilize non-specific therapeutic techniques, including providing unconditional positive regard, reflective listening, encouraging, paraphrasing, and summarizing. Therapists do not develop a formulation or teach skills."
16340767|NCT00338975|Behavioral|Social Skills Training|The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. Participants engage in role plays and problem solving.
16340768|NCT00338975|Behavioral|Goal Setting|All participants are asked to identify a personally meaningful goal as soon as possible in therapy. Over the 36 weeks, participants in CBSST learn skills related to goal attainment, while participants in GFSC do not receive skills aimed at goal attainment, but are encouraged to discuss their goals .
16340769|NCT00338962|Drug|paroxetine|paroxetine (40mg/day)
16340770|NCT00338962|Drug|desipramine|200 mg per day
16340771|NCT00338962|Drug|Naltrexone|50 mg per day
16340772|NCT00338962|Drug|Placebo|placebo
16340773|NCT00338949|Drug|Switch|Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
16340774|NCT00338949|Drug|Control|Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
16340775|NCT00338936|Drug|Valsartan + Hydrochlorothiazide|
16340776|NCT00338923|Drug|HO/03/03|
16340777|NCT00338910|Drug|Budesonide 2 single doses, Metronidazole multiple-dose|Budesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9.
16340778|NCT00338897|Drug|SR123781A|
16340779|NCT00338884|Drug|Sunitinib malate|Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
16340780|NCT00338871|Procedure|home exercise|
16340781|NCT00338858|Other|walking and balance performance evaluation|
16340782|NCT00338858|Procedure|muscle strength, walking and balance performance|HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test
16340783|NCT00338845|Behavioral|Share Safer Sex program|The Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her knowledge about how to practice safe sex. Demonstrations and practice exercises will be used to improve participants' attitudes about, as well as intentions to practice, condom use. The counseling session will include the following activities: assessing readiness for change; building motivation for change; and performing exercises in decisional balance, identification of problem and problem-solving, and knowledge and skill-building.
16340784|NCT00338845|Behavioral|Standard didactic safer-sex counseling program|The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention, and will focus on personal risk assessment and strategies for risk reduction. Additionally, it will incorporate risk reduction materials provided by CENSIDA, Mexico's National Center for AIDS Studies.
16340785|NCT00338832|Behavioral|Physically Ready for Invigorating Movement Every Day (PRIME)|The PRIME program is a lifestyle intervention focused on increasing physical activity. The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults. The program has been modified based on theory and empirical findings about this special subgroup. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
16340786|NCT00338832|Behavioral|Program for Activity, Leisure Skills, and Socialization (PALSS)|PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
16340787|NCT00338806|Behavioral|Interpersonal psychotherapy for prevention with adolescents|Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
16340788|NCT00338806|Behavioral|Educational clinical monitoring|Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
16340789|NCT00338793|Drug|prednisolone|
16340790|NCT00338780|Drug|Lamivudine/ Placebo 100mg daily|
16340791|NCT00338767|Behavioral|Directly Observed Therapy (DOT)|DOT includes storefront directly observed therapy of prescribed anti-depressants. Participants will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen.
16340792|NCT00338767|Drug|Fluoxetine|Medication treatment includes flouxetine for treatment of depression.
16340793|NCT00338754|Drug|Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks|
16340794|NCT00338728|Drug|Imatinib Mesylate|Given PO
16340795|NCT00338728|Drug|Letrozole|Given PO
16340796|NCT00338715|Device|PVI with Medtronic's Cardioblate BP2 radiofrequency catheter|Ablation of the right and left pulmonary veins
16340797|NCT00338702|Procedure|Autologous Platelet Gel|
16340798|NCT00338689|Dietary Supplement|Lower protein formula; Higher protein formula|During the intervention phase of the study, which is from inclusion in the study (latest age 2 weeks) until age 12 months, two experimental infant formulae with different protein content are fed to the enrolled infants; Lower protein formula and Higher protein formula. Additional a breastfed observational group without any intervention is included.
16340799|NCT00338663|Device|knee immobilization splint|
16340800|NCT00338650|Drug|adalimumab|
16340801|NCT00338637|Device|APOS shoe kit|
16340802|NCT00338624|Drug|oxybutynin chloride extended release|
16340803|NCT00338611|Behavioral|Home-based Pencil Push-Up Therapy|Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
16340804|NCT00338611|Behavioral|Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics|Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose combined with additional computer vision therapy
16340805|NCT00338611|Behavioral|Office-based Vision Therapy/Orthoptics|Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
16340806|NCT00338611|Behavioral|Placebo Office-based Vision Therapy/Orthoptics|Vision activities designed to simulate office-based therapy
16340807|NCT00338598|Drug|Glycine|Glycine, 0.8 gr per kg given in two daily doses
16340808|NCT00338598|Drug|placebo|
16340809|NCT00338585|Drug|alfimeprase|
16340810|NCT00338572|Behavioral|Exercise Program|Participants in the exercise group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day.
16340811|NCT00338572|Behavioral|Combined Exercise and Diet Program|Participants in this group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day. They will meet with a dietician and will be encouraged to reduce their caloric intake by incorporating low-fat, high-fiber foods into their diet.
16340812|NCT00338546|Drug|Cocaine hydrochloride|
16340813|NCT00338546|Drug|Dexmedetomidine|
16340814|NCT00338546|Procedure|Microneurography|
16340815|NCT00338546|Procedure|Laser doppler velocimetry|
16340816|NCT00338533|Device|endoscopic goniotomy|The goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye
16340817|NCT00338507|Drug|Erdosteine|
16340818|NCT00338494|Drug|Clofarabine|The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.
16340819|NCT00338481|Drug|Morphine p.o.|"Morphine p.o. in red morphine drops calculated as 1/12 of the 24 hours opioid consumption converted to morphine p.o., max. 24 mg morphine p.o.and isotonic sodium chloride s.c."
16340820|NCT00338481|Drug|Morphine s.c.|"False red morphine drops without morphine p.o. and 60% of 1/12 of the 24 hours opioid consumption converted to morphine p.o. but given s.c., max. 14,4 mg"
16340821|NCT00338468|Drug|epoetin alfa|
16340822|NCT00338455|Drug|Natrecor (nesiritide)+Standard Care+dobutamine or milrinone|3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
16340823|NCT00338455|Drug|Placebo+Standard Care+dobutamine or milrinone|28-day continuous infusion, no bolus
16340824|NCT00338442|Drug|VariZIG™|Biological / Vaccine
16340825|NCT00338429|Behavioral|FHP Sleep Program|Cognitive-Behavioral Intervention
16340826|NCT00338416|Drug|Epoetin alfa|
16340827|NCT00338403|Procedure|Continuous positive airway pressure (CPAP) at -5, 0, 5 and 10 cm of water|
16340828|NCT00338390|Drug|Abacavir|Change tenofovir to abacavir
16340829|NCT00338390|Drug|Didanosine|Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.
16340830|NCT00338390|Drug|Abacavir+Lamivudine|Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
16340831|NCT00338377|Biological|Dendritic Cell Immunization|1x10^7 to 2.5x10^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.
16340832|NCT00338377|Drug|Cyclophosphamide|60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
16340833|NCT00338377|Drug|Fludarabine|25 mg/m^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
16340834|NCT00338377|Biological|T-Cells|On Days 0, up to 1.5 x 10^11 T-cells by vein infusion over 30-60 minutes.
16340835|NCT00338377|Biological|Interleukin-2|12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26 (+/- 7 days), as tolerated.
16340836|NCT00338377|Drug|Mesna|60 mg/kg with D5W or NS at 125 ml/hr infused intravenously over 24 hours on Day -7 and -6.
16340837|NCT00338377|Biological|Intrathecal T-Cells|5.0x10^9 T-cells administered on Day 1, and 10x10^9 T-cells on Day 15. 1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated.
16340838|NCT00338377|Biological|Intrathecal Interleukin-2|1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated. Then, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks patients switched to IL-2 maintenance.
16340839|NCT00338364|Behavioral|PAT|Coping and Distraction Intervention
16340840|NCT00338351|Biological|Pneumococcal (vaccine)|
16340841|NCT00338338|Drug|Lacidipine 4 or 6 mg (oral)|
16340842|NCT00338338|Drug|Amlodipine 5 or 10 mg(oral)|
16340843|NCT00338325|Behavioral|Reading program|Reading of children's story/picture books preoperatively
16340844|NCT00338312|Drug|Testosterone Transdermal System|testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
16340845|NCT00338312|Drug|Placebo patch|placebo patch changed twice a week for one year
16340846|NCT00338299|Drug|Epoetin alfa|
16340847|NCT00338286|Other|Standard supportive care (packed RBC transfusion)|Per doctor prescription
16340848|NCT00338286|Drug|epoetin alfa + packed RBC transfusion|40,000 IU SC once a week.
16340849|NCT00338273|Drug|Aripiprazole|Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
16340850|NCT00338273|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
16340851|NCT00338260|Drug|MK0954, /Duration of Treatment : 5 Years|
16340852|NCT00338260|Drug|Comparator : atenolol /Duration of Treatment : 5 Years|
16340853|NCT00338247|Drug|lapatinib + capecitabine|Experimental
16340854|NCT00338221|Drug|alanyl-glutamine|
16340855|NCT00338221|Drug|glycine|
16340856|NCT00338208|Behavioral|Training in the Use of Low Vision Devices|
16340857|NCT00338195|Behavioral|Individualized caffeine cessation instructions|Intervention is described in the protocol
16340858|NCT00338182|Drug|AZD1152 part A|48-hour continuous intravenous infusion
16340859|NCT00338182|Drug|AZD1152 part B|2-hour intravenous infusion
16340860|NCT00338143|Drug|efalizumab|
16340861|NCT00338130|Drug|AZD6244|Oral liquid or Capsule
16340862|NCT00338130|Drug|Temozolomide|oral
16340863|NCT00338117|Drug|Galantamine hydrobromide|
16340864|NCT00338104|Drug|insulin glargine|Insulin glargine given at 40% of prior stable drip rate.
16340865|NCT00338104|Drug|insulin glargine|Insulin glargine given at 60% of prior stable drip rate.
16340866|NCT00338104|Drug|insulin glargine|Insulin glargine given at 80% of prior stable drip rate.
16340869|NCT00338078|Device|nocturnal oxygen treatment from oxygen concentrators|
16340870|NCT00338065|Behavioral|Postural change|Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
16340871|NCT00338065|Behavioral|Water drinking|Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.
16340872|NCT00338052|Drug|Norethindrone 1 mg / ethinyl estradiol 20 mcg|
16340873|NCT00338039|Drug|Cetuximab|500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.
16340874|NCT00338039|Drug|Gemcitabine|"Induction Therapy: 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses.
~Chemotherapy Maintenance: 1 gm/m^2/week over 100 minutes weekly for 3 weeks then 1 week off."
16340875|NCT00338039|Drug|Oxaliplatin|Induction Chemotherapy: 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.
16340876|NCT00338039|Drug|Capecitabine|Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation.
16340877|NCT00338039|Radiation|Radiotherapy|Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
16340878|NCT00338026|Drug|ECO-4601|Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
16340879|NCT00338000|Drug|Epoetin alfa|
16340880|NCT00337987|Drug|Ontak|ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
16340881|NCT00337987|Drug|CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy|ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
16340882|NCT00337974|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
16340883|NCT00337974|Other|Educational DVDs|
16340884|NCT00337961|Procedure|Optic Nerve Sheath Fenestration|
16340885|NCT00337948|Drug|Epoetin alfa|
16340886|NCT00337935|Drug|Epoetin Alfa|Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
16340887|NCT00337935|Other|Standard of care|
16340888|NCT00337922|Drug|Lamivudine / Abacavir Sulfate|
16340889|NCT00337909|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
16340890|NCT00337909|Other|Educational DVDs|
16340891|NCT00337883|Drug|Erlotinib HCl (OSI-774)|
16340892|NCT00337870|Behavioral|PAT|Cognitive-Behavioral/Relaxation Intervention
16340893|NCT00337831|Procedure|Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration|Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
16340894|NCT00337818|Biological|Cervarix™|Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
16340895|NCT00337805|Other|Pentaspan|When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
16340896|NCT00337792|Drug|oxycodone + lorazepam versus fentanyl + midazolam|
16340897|NCT00337779|Drug|Glatiramer Acetate (GA) 40 mg|Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
16340898|NCT00337779|Drug|glatiramer acetate 20 mg|Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
16340899|NCT00337766|Drug|Desmopressin (DDAVP)|
16340900|NCT00337766|Drug|Placebo|
16340901|NCT00337753|Behavioral|Cognitive Behavioral Therapy|5-weeks of Cognitive Behavioral Therapy
16340902|NCT00337753|Behavioral|Wait-list|subjects assigned to wait-list condition for six-weeks
16340903|NCT00337740|Procedure|endoscopic variceal banding|
16340904|NCT00337740|Drug|propranolol|
16340905|NCT00337727|Drug|aprepitant|aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
16340906|NCT00337727|Drug|Comparator: ondansetron|Ondansetron 8 mg capsule Three day treatment period.
16340907|NCT00337727|Drug|Comparator: dexamethasone|dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
16340908|NCT00337727|Drug|Comparator: fosaprepitant dimeglumine|fosaprepitant dimeglumine 115 mg
16340909|NCT00337727|Drug|Comparator; Placebo (unspecified)|dexamethasone 12mg Pbo tablets.
16340910|NCT00337727|Drug|Comparator; Placebo (unspecified)|Aprepitant 80 mg & 125 mg Pbo capsules.
16340911|NCT00337714|Procedure|CVC impregnated with silver nanoparticles (AgTive®)|insertion of medicated silver nanoparticles CVC
16340912|NCT00337714|Procedure|CVC cannulation|placement of conventional trilumen CVCs
16340913|NCT00337701|Drug|enfuvirtide [Fuzeon]|90mg sc bid by Biojector 2000 NFID for 8 weeks
16340914|NCT00337701|Drug|enfuvirtide [Fuzeon]|90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
16340915|NCT00337688|Device|isometric joystick|isometric joystick
16340916|NCT00337675|Drug|montelukast sodium|Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
16340917|NCT00337675|Drug|Comparator: Placebo (unspecified)|Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
16340918|NCT00337675|Drug|montelukast sodium|Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
16340919|NCT00337662|Drug|olanzapine|10-20 milligrams (mg), oral, daily, 10 weeks.
16340920|NCT00337662|Drug|risperidone|2-6 mg, oral, daily, for 10 weeks.
16340921|NCT00337662|Drug|risperidone|2-6 mg, oral, daily, 10 weeks
16340922|NCT00337649|Drug|Epothilone D|<100mg/m2 iv on days 1, 8 and 15 every 4 weeks
16340923|NCT00337649|Drug|Herceptin|4mg/kg iv loading dose followed by 2mg/kg iv weekly
16340924|NCT00337636|Procedure|Surgery to implant human CNS stem cells (HuCNS-SC)|single dose
16340925|NCT00337636|Drug|Medication to suppress the immune system|Immunosuppression for 12 months post transplant
16340926|NCT00337623|Drug|Prednisolone|
16340986|NCT00337194|Drug|vinorelbine tartrate|Given IV
16340927|NCT00337610|Drug|sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day|Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
16340928|NCT00337610|Drug|comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day|Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.
16340929|NCT00337597|Other|Glucose 5%|
16340930|NCT00337597|Other|NaCl 0.9%|
16340931|NCT00337584|Procedure|Pre-surgical screening|
16340932|NCT00337571|Drug|Aripiprazole|Tablets, Oral, once daily, 8 weeks
16340933|NCT00337571|Drug|Placebo|Tablets, Oral, once daily, 8 weeks
16340934|NCT00337558|Drug|Solifenacin succinate|tablet
16340935|NCT00337558|Behavioral|Simplified bladder training|Instructions
16340936|NCT00337545|Drug|RAD001|
16340937|NCT00337532|Drug|Paclitaxel|Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
16340938|NCT00337532|Drug|cisplatin|solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
16340939|NCT00337519|Procedure|allogeneic stem cell transplantation|see detailed description
16340940|NCT00337519|Drug|Alemtuzumab|alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14
16340941|NCT00337506|Drug|Dexamethasone|
16340942|NCT00337506|Drug|velcade|
16340943|NCT00337493|Drug|mycophenolate mofetil [CellCept]|Concentration-controlled
16340944|NCT00337493|Drug|mycophenolate mofetil [CellCept]|1g po bid
16340945|NCT00337493|Drug|Cyclosporine or tacrolimus|Reduced
16340946|NCT00337493|Drug|Cyclosporine or tacrolimus|Standard, as prescribed
16340947|NCT00337480|Behavioral|education|education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
16340948|NCT00337467|Drug|Atazanavir + Ritonavir|Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
16340949|NCT00337454|Drug|Dasatinib|Tablets, Oral, 50mg BID, once daily, 24 weeks.
16340950|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 24 weeks.
16340951|NCT00337454|Drug|Dasatinib|Tablets, Oral, 90mg BID, once daily, 24 weeks.
16340952|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 24 weeks.
16340953|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 12 weeks.
16340954|NCT00337454|Drug|Dasatinib|Tablets, Oral, 70mg BID, once daily, 12 weeks.
16340955|NCT00337441|Drug|Epoetin Alfa (drug)|
16340956|NCT00337428|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)|GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
16340957|NCT00337428|Biological|Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)|GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
16340958|NCT00337428|Biological|Comparator: REPEVAX™ (Concomitant)|REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
16340959|NCT00337428|Biological|Comparator: REPEVAX™ (Non-Concomitant)|REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
16340960|NCT00337415|Drug|MK0354|
16340961|NCT00337389|Drug|5- Fluorouracil (5-FU)|
16340962|NCT00337389|Drug|bevacizumab (Avastin)|
16340963|NCT00337389|Drug|Leucovorin|
16340964|NCT00337389|Drug|CoFactor (ANX-510)|
16340965|NCT00337376|Drug|Rapamune|Dose escalation as follows: 5mg PO, 10mg PO, 20mg PO, 40mg PO
16340966|NCT00337376|Drug|Abraxane|intravenous administration of 100mg/m2 Abraxane over 30 minutes, weekly for three out of four consecutive weeks.
16340967|NCT00337350|Drug|rosiglitazone|Rosiglitazone 4mg, one capsule per day for eight weeks
16340968|NCT00337350|Drug|placebo|matched placebo for rosiglitazone 4mg/day
16340969|NCT00337337|Behavioral|Multiple grain|
16340970|NCT00337337|Behavioral|Ordinary Asian- rice|
16340971|NCT00337324|Device|Frequency-modulated electromagnetic neural stimulation|
16340972|NCT00337298|Drug|Amlodipine|1 (5mg) tablet daily, given 14 days totally before measure of outcome.
16340973|NCT00337298|Drug|Lisinopril|Lisinopril 10 mg given daily for 14 days and then outcome was measured.
16340974|NCT00337285|Drug|Vyvanse (lisdexamfetamine dimesylate), NRP104|NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg
16340975|NCT00337272|Drug|Placebo|Placebo taken 30 minutes before bedtime days 1-28 of treatment period
16340976|NCT00337272|Drug|Ramelteon|8 mgs daily for days 1-28 of treatment period
16340977|NCT00337259|Drug|gemcitabine|D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
16340978|NCT00337246|Biological|rituximab|
16340979|NCT00337246|Drug|cyclophosphamide|
16340980|NCT00337246|Drug|fludarabine phosphate|
16340981|NCT00337246|Drug|mitoxantrone hydrochloride|
16340982|NCT00337233|Procedure|yoga therapy|10 week yoga class
16340983|NCT00337207|Biological|bevacizumab|Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.
16340984|NCT00337194|Biological|monoclonal antibody SGN-30|Given IV
16340987|NCT00337194|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16340988|NCT00337194|Drug|gemcitabine hydrochloride|Given IV
16340989|NCT00337194|Other|laboratory biomarker analysis|Correlative studies
16340990|NCT00337194|Other|pharmacological study|Correlative studies
16340991|NCT00337168|Drug|clofarabine|Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
16340992|NCT00337168|Drug|cytarabine|Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4
16340993|NCT00337155|Drug|Radium-223 dichloride (BAY88-8223)|3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.
16340994|NCT00337129|Drug|eribulin mesylate|1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
16340995|NCT00337116|Drug|iso sorbide dinitrate iv bolus or s/l|
16340996|NCT00337103|Drug|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
16340997|NCT00337103|Drug|Capecitabine|Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
16340998|NCT00337090|Drug|YM178|
16340999|NCT00337077|Drug|eribulin mesylate|Given IV
16341000|NCT00337064|Procedure|Radiation Therapy|
16341001|NCT00337051|Drug|Sevoflurane|General anesthesia using Sevoflurane (inhalation) as hypnotic
16341002|NCT00337051|Drug|Propofol|General anesthesia with propofol TCI
16341003|NCT00337038|Drug|N-acetylcystein(drug)|p.O t.Siran 200mg x1 during one weak
16341004|NCT00336986|Drug|recombinant interleukin-21|
16341005|NCT00336973|Drug|efalizumab|Subcutaneous repeating dose
16341006|NCT00336960|Drug|celecoxib|twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
16341007|NCT00336960|Drug|fluorouracil|Patients receive concurrent fluorouracil IV continuously for 5 weeks.
16341008|NCT00336960|Procedure|conventional surgery|4-10 weeks after completion of chemoradiotherapy
16341009|NCT00336960|Radiation|radiation therapy|Patients undergo radiotherapy 5 days a week for 5 weeks
16341010|NCT00336960|Procedure|tumor biopsy|at baseline and then at the time of surgical resection
16341011|NCT00336960|Other|laboratory biomarker analysis|blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
16341012|NCT00336947|Drug|tegafur-gimeracil-oteracil potassium|
16341013|NCT00336947|Drug|tegafur-uracil|
16341014|NCT00336947|Procedure|adjuvant therapy|
16341015|NCT00336934|Dietary Supplement|pomegranate juice|Given orally daily.
16341016|NCT00336934|Other|placebo|Given orally daily.
16341017|NCT00336921|Drug|Alfuzosin|Once daily
16341018|NCT00336921|Drug|Placebo|Once daily
16341019|NCT00336908|Drug|a combination of MCT, LCT , and Fish Oil|
16341020|NCT00336895|Drug|Myfortic|Myfortic 360mg or 720 mg BID for 90 days.
16341021|NCT00336882|Drug|Propofol|Propofol at a dose of 1 mg/kg/hour with a dose increase of 1 mg/kg until therapeutic effect (with a maximum dose of 5 mg/kg/hour)
16341022|NCT00336882|Drug|Midazolam|Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
16341023|NCT00336856|Drug|Cetuximab|The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
16341024|NCT00336856|Drug|Irinotecan|The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
16341025|NCT00336843|Drug|Zevalin-BuCyE|rituximab (IV, 250 mg/m2 on days -21 and -14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day -14) Busulfan (IV, 0.8 mg/kg every 6 h from day -7 to day -5) Cyclophosphamide (IV, 50 mg/kg on days -3 and -2) Etoposide (IV, 200 mg/m2 every 12 h on days -5 and -4) Autologous stem cells infusion on day 0
16341026|NCT00336830|Behavioral|MD-endorsed Cardiac Rehabilitation referral|Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.
16341027|NCT00336830|Behavioral|Standard Cardiac Rehabilitation referral|Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.
16341028|NCT00336817|Drug|Myfortic|Myfortic 360mg or 720 mg BID for 90 days
16341029|NCT00336817|Drug|CellCept|CellCept 500mg or 1000mg BID for 90 days
16341030|NCT00336791|Drug|5-Fluorouracil|"FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle.
~FAC Chemotherapy: 500 mg/m^2 IV on day 1 and day 4 of 21 day cycle."
16341031|NCT00336791|Drug|Cyclophosphamide|"FAC and FEC Chemotherapy:
~500 mg/m^2 IV on day 1 of 21 day cycle."
16341032|NCT00336791|Drug|Doxorubicin|FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
16341033|NCT00336791|Drug|Paclitaxel|80 mg/m^2 by vein (IVPB) over 1 hour every week for 12 weeks
16341034|NCT00336791|Drug|Epirubicin|FEC: 100 mg/m^2 IV on day 1 of 21 day cycle.
16341035|NCT00336778|Drug|3TC, TDF, NLV|3TC 300 mg PO once daily+ TDF 300 mg PO once daily+ NLV 1250 mg PO twice daily (after 12 week lead-in period)
16341036|NCT00336765|Drug|XL647|Tablets supplied in 50-mg strength administered orally daily
16341037|NCT00336752|Procedure|non operative treatment|non operative treatment -casting for 6 weeks
16341038|NCT00336752|Procedure|operative treatment of ankle fractures|operative treatment of ankle fractures
16341039|NCT00336739|Drug|cinacalcet|
16341040|NCT00336713|Drug|Saredutant (SR48968C)|oral administration (capsules)
16341041|NCT00336713|Drug|Placebo|oral administration (capsules)
16341042|NCT00336700|Drug|Gemcitabine|1500mg/m2 IV over 150 min IV q 2 weeks 4 months
16341043|NCT00336700|Drug|Erlotinib|150 mg/d Daily, oral 12 months
16341044|NCT00336674|Biological|Intranasal insulin|440IU Insulin
16341045|NCT00336674|Other|Placebo|Placebo insulin carrier solution containing benzalkonium chloride and glycerol
16341046|NCT00336661|Device|PerioWave|
16341047|NCT00336648|Drug|Avastin (Bevacizumab)|10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
16341048|NCT00336648|Drug|Gemcitabine|400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
16341049|NCT00336648|Procedure|Radiation Therapy|Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
16341050|NCT00336635|Biological|cell-culture derived smallpox vaccine|
16341051|NCT00336622|Device|Splint fabricated by an OT versus an off-the-shelf splint|"Experimental:
~Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises
~Control:
~Control: Off-the-shelf splint and tendon-nerve gliding exercises Off-the-shelf splint and no tendon-nerve gliding exercises"
16341052|NCT00336596|Procedure|transcranial ultrasound in patients treated with iv t-PA|
16341053|NCT00336583|Drug|Oxaliplatin|Oxaliplatin, 130 mg per square meter, on day 1
16341054|NCT00336557|Procedure|NAbs testing|blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
16341055|NCT00336544|Drug|Cethromycin|Cethromycin 300 mg once per day (QD) for 7 days, administered orally
16341056|NCT00336544|Drug|Clarithromycin|Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
16341057|NCT00336531|Drug|itraconazole|2.5 mg/kg twice daily for the first two days --> once daily
16341058|NCT00336518|Drug|peginterferon alfa-2a|
16341059|NCT00336518|Drug|ribavirin|
16341060|NCT00336505|Drug|Cethromycin|Cethromycin 300 mg once per day (QD) for 7 days, administered orally
16341061|NCT00336505|Drug|Clarithromycin|Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
16341062|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42
16341063|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46
16341064|NCT00336492|Biological|infliximab|infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42
16341065|NCT00336492|Biological|infliximab|infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
16341066|NCT00336479|Drug|Telaprevir|tablet
16341067|NCT00336479|Drug|Ribavirin|tablet
16341068|NCT00336479|Drug|Pegylated Interferon Alfa 2a|Solution for injection
16341069|NCT00336479|Other|Placebo|matching placebo tablet
16341070|NCT00336466|Drug|Human recombinant erythropoietin|
16341071|NCT00336453|Biological|Influenza Vaccination|0.5mL dose for intramuscular injection
16341072|NCT00336453|Biological|Influenza Vaccination|0.25mL dose for intramuscular injection
16341073|NCT00336414|Drug|cyclophosphamide-prednisone-azathioprine|
16341074|NCT00336401|Drug|Sevoflurane or Propofol|
16341075|NCT00336388|Device|Paracheck Device|
16341076|NCT00336375|Drug|artemether-lumefantrine|All treatment doses given either accompanied or not-accompanied with intake of fatty food.
16341077|NCT00336362|Drug|Hydroxyurea|"Hydroxyurea: Subjects will be treated for one month with hydroxyurea at a starting dose of 10 mg/kg orally (closest approximation to 500 mg capsule, alternate day dosing, e.g. 500 alternating with 1000 to achieve 750 mg average daily dose), once daily, with a gradual dose escalation up to 20 mg/kg (in non-splenectomized patients) and up to 25 mg/kg (in splenectomized patients).
~G-CSF: G-CSF will be administered subcutaneously. In general, G-CSF will be administered at 10μg/kg/day (5μg/kg on a twice a day schedule) for at least 4-5 days before leukapheresis and for 1-2 additional days during collections. For the splenectomized patients who are not receiving HU pretreatment, and for the splenectomized patients who receive HU pretreatment who have greater than or equal to 12,000 WBCs before G-CSF, G-CSF will start at a lower dose (for example, 1.5 or 2.5 µg/kg); the next doses will be adjusted by the Principal Investigator based on the observed degree of leukocytosis."
16341078|NCT00336349|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A
16341079|NCT00336336|Drug|n-3 PUFA|1 g die per os
16341080|NCT00336336|Drug|Rosuvastatin|10 mg die per os
16341081|NCT00336336|Drug|Placebo|1 gram c. per os
16341082|NCT00336336|Drug|Placebo|10 mg c. per os
16341083|NCT00336323|Procedure|Laser Photocoagulation|Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
16341084|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
16341085|NCT00336323|Drug|Bevacizumab|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
16341086|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
16341087|NCT00336323|Drug|Bevacizumab|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
16341088|NCT00336310|Drug|Repaglinide|
16341089|NCT00336297|Procedure|Woman Abuse Screening Tool|
16341090|NCT00336297|Procedure|Partner Violence Screen|
16341091|NCT00336297|Procedure|Computerized screening|
16341092|NCT00336297|Procedure|Face to face screening|
16341093|NCT00336297|Procedure|Written screening on forms|
16341094|NCT00336284|Other|Home Monitoring|Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.
16341095|NCT00336284|Other|In-Office Conventional Follow-up|Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
16341359|NCT00334672|Drug|dexamethasone|
16341096|NCT00336245|Device|Copper T Intrauterine Contraceptive Device|
16341097|NCT00336245|Drug|Hormonal Contraception|
16341098|NCT00336232|Drug|Vitamin K|phylloquinone (vitamin K1) 500 mcg daily in third month
16341099|NCT00336219|Drug|Pantoprazole|Symptom Assessment after treatment with Pantoprozole 40 mg
16341100|NCT00336206|Drug|Alemtuzumab|
16341101|NCT00336193|Behavioral|Home visitation|Home visitation to improve maternal health and well-being and parenting practices
16341102|NCT00336180|Behavioral|HealthWise South Africa curriculum|18 classroom lessons
16341103|NCT00336167|Drug|bezafibrate (drug)|
16341104|NCT00336154|Drug|tetracyclin|
16341105|NCT00336141|Drug|Suberoylanilide hydroxamic acid|400 mg QD (every day) for five days, followed by 9 days of no vorinostat
16341106|NCT00336128|Behavioral|attitude change|TigerKids: setting based prevention program to reduce obesity risk factors in children
16341107|NCT00336128|Behavioral|adiposity prevention program|The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting
16341108|NCT00336115|Biological|Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)|
16341109|NCT00336102|Other|physiologic testing|Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.
16341110|NCT00336102|Procedure|fatigue assessment and management|Fatigue Symptoms Inventory (FSI) survey
16341111|NCT00336102|Procedure|management of therapy complications|If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control
16341112|NCT00336089|Behavioral|exercise intervention|
16341113|NCT00336089|Other|educational intervention|
16341114|NCT00336089|Procedure|complementary or alternative medicine procedure|
16341115|NCT00336089|Procedure|fatigue assessment and management|
16341116|NCT00336089|Procedure|management of therapy complications|
16341117|NCT00336089|Procedure|pain therapy|
16341118|NCT00336089|Procedure|quality-of-life assessment|
16341119|NCT00336076|Other|Collection of blood and bone marrow|5-8 cc blood or bone marrow was additionally collected for analysis during diagnostic procedures. No assigned interventions.
16341120|NCT00336063|Drug|Azacitidine|Given SC
16341121|NCT00336063|Other|Laboratory Biomarker Analysis|Correlative studies
16341122|NCT00336063|Other|Pharmacological Study|Correlative studies
16341123|NCT00336063|Drug|Vorinostat|Given PO
16341124|NCT00336024|Drug|etoposide|Given IV
16341125|NCT00336024|Drug|cyclophosphamide|Given IV
16341126|NCT00336024|Drug|cisplatin|Given IV
16341127|NCT00336024|Biological|filgrastim|Given IV or SC
16341128|NCT00336024|Drug|carboplatin|Given IV
16341129|NCT00336024|Drug|thiotepa|Given IV
16341130|NCT00336024|Drug|methotrexate|Given IV
16341131|NCT00336024|Drug|leucovorin calcium|Given IV or orally
16341132|NCT00336024|Drug|vincristine sulfate|Given IV
16341133|NCT00336024|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSC rescue
16341134|NCT00336024|Other|laboratory biomarker analysis|Correlative studies
16341135|NCT00336024|Procedure|quality-of-life assessment|Ancillary studies
16341136|NCT00336011|Device|Magnetic resonance imaging|
16341137|NCT00335998|Drug|triapine|Given IV
16341138|NCT00335998|Other|laboratory biomarker analysis|Correlative studies
16341139|NCT00335998|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
16341140|NCT00335998|Radiation|brachytherapy|Undergo intracavitary or interstitial brachytherapy
16341141|NCT00335998|Drug|cisplatin|Given IV
16341142|NCT00335998|Other|pharmacological study|Correlative studies
16341143|NCT00335985|Drug|GB-0998|8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
16341144|NCT00335985|Drug|Placebo of GB-0998|8 mL/kg per day is intravenously administered for five successive days
16341145|NCT00335972|Drug|Remifentanil|Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
16341146|NCT00335972|Drug|Dexmedetomidine|Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
16341147|NCT00335959|Drug|capecitabine|850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.
16341148|NCT00335959|Drug|oxaliplatin|130 mg/m2 by 2-hour infusion Days 1 and 22
16341149|NCT00335959|Procedure|conventional surgery|Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy
16341150|NCT00335959|Radiation|radiation therapy|Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.
16341151|NCT00335946|Device|HANS non-needle acupuncture|
16341152|NCT00335946|Procedure|Stimulation of two acupuncture points bi-lateral|
16341153|NCT00335933|Drug|Gabapentin extended-release tablets|
16341154|NCT00335920|Drug|Dexamethasone-dihydrogenphosphate (4mg/ml)|
16341155|NCT00335907|Procedure|Fluid and Vasopressor Protocol|A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol
16341156|NCT00335894|Drug|hMG-IBSA|
16341157|NCT00335881|Biological|hepatitis B vaccine|
16341158|NCT00335868|Drug|danusertib|
16341159|NCT00335868|Other|laboratory biomarker analysis|
16341160|NCT00335868|Other|pharmacological study|
16341161|NCT00335855|Device|Auto-injector for IM/SC vaccine administration|
16341162|NCT00335829|Biological|bevacizumab|
16341163|NCT00335829|Drug|chemotherapy|
16341164|NCT00335829|Drug|embolization therapy|
16341165|NCT00335829|Procedure|hepatic artery infusion|
16341166|NCT00335816|Drug|fluorouracil|Given IV
16341167|NCT00335816|Drug|leucovorin calcium|Given IV
16341168|NCT00335816|Drug|oxaliplatin|Given IV
16341169|NCT00335816|Procedure|conventional surgery|Patients undergo surgery
16341170|NCT00335816|Radiation|radiation therapy|Patients undergo radiotherapy
16341171|NCT00335816|Other|laboratory biomarker analysis|Correlative studies
16341172|NCT00335816|Genetic|DNA analysis|Correlative studies
16341173|NCT00335816|Genetic|polymerase chain reaction|Correlative studies
16341174|NCT00335816|Other|immunohistochemistry staining method|Correlative studies
16341175|NCT00335790|Procedure|Hyperbaric Therapy|
16341176|NCT00335777|Drug|Migranal nasal spray|Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
16341177|NCT00335777|Drug|Migranal nasal spray|Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
16341178|NCT00335764|Drug|sorafenib tosylate|given orally
16341179|NCT00335764|Drug|erlotinib hydrochloride|given orally
16341180|NCT00335764|Drug|tipifarnib|given orally
16341181|NCT00335764|Drug|temsirolimus|IV administration
16341182|NCT00335751|Procedure|positron emission tomography computed tomography (PET/CT)|The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.
16341183|NCT00335738|Drug|liposomal vincristine sulfate|Given IV
16341184|NCT00335738|Drug|carboplatin|Given IV
16341185|NCT00335738|Drug|etoposide|Given IV
16341186|NCT00335725|Drug|Follicle Stimulating Hormone|subcutaneous injection of FSH. Starting dose: 225 IU.
16341187|NCT00335725|Drug|Follicle Stimulating Hormone|subcutaneous injection of FSH. Starting dose: 225 IU.
16341188|NCT00335712|Drug|ONO-5129|
16341189|NCT00335699|Drug|Rosuvastatin|
16341190|NCT00335686|Drug|Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h|Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
16341191|NCT00335686|Drug|Nevirapine (Viramune): 1 comp (200mg)/12h|Nevirapine (Viramune): 1 comp (200mg)/12h
16341192|NCT00335673|Drug|Irbesartan (Aprovel)|Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
16341193|NCT00335660|Drug|AV608|
16341194|NCT00335647|Drug|fluphenazine hydrochloride|
16341195|NCT00335621|Drug|Inhaled Tiotropium|
16341196|NCT00335595|Drug|XELOXA|XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks
16341197|NCT00335595|Drug|XELOXA-A|"XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study.
~One cycle every 3 weeks"
16341198|NCT00335582|Drug|clonidine hydrochloride|One hour prior to surgery, patients randomized to the treatment arm will receive clonidine as both a 0.2 mg oral tablet and 0.2 mg/day transdermal patch patch will be removed on postoperative day 4 (or hospital discharge, whichever is earlier)
16341199|NCT00335569|Drug|hCG-IBSA|
16341200|NCT00335556|Drug|Doxorubicin Hydrochloride|Given IV
16341201|NCT00335556|Drug|Irinotecan Hydrochloride|Given IV
16341202|NCT00335556|Procedure|Conventional Surgery|Patients undergo resection
16341203|NCT00335556|Drug|Cyclophosphamide|Given IV
16341204|NCT00335556|Drug|Etoposide|Given IV
16341205|NCT00335556|Drug|Carboplatin|Given IV
16341206|NCT00335556|Biological|Dactinomycin|Given IV
16341207|NCT00335556|Drug|Vincristine Sulfate|Given IV
16341208|NCT00335556|Radiation|Radiation Therapy|Undergo radiotherapy
16341209|NCT00335556|Other|Laboratory Biomarker Analysis|Correlative studies
16341210|NCT00335543|Drug|cisplatin|
16341211|NCT00335543|Drug|gemcitabine hydrochloride|
16341212|NCT00335543|Procedure|adjuvant therapy|
16341213|NCT00335543|Procedure|conventional surgery|
16341214|NCT00335543|Procedure|neoadjuvant therapy|
16341215|NCT00335543|Radiation|radiation therapy|
16341216|NCT00335517|Drug|DepoDur|An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDur will be injected.
16341217|NCT00335504|Drug|oligofructose-enriched inulin|Given orally
16341218|NCT00335504|Drug|sulindac|Given orally
16341219|NCT00335504|Drug|placebo|Given orally
16341220|NCT00335504|Drug|atorvastatin calcium|Given orally
16341221|NCT00335504|Other|laboratory biomarker analysis|Correlative studies
16341222|NCT00335491|Behavioral|exercise intervention|12 weeks of 3x/week training on a recumbent eccentric stepper
16341223|NCT00335491|Procedure|complementary or alternative medicine procedure|12 weeks of 3x/week training on the eccentron
16341224|NCT00335491|Procedure|fatigue assessment and management|The visual analog scale will be used to assess muscle soreness from the previous exercise session
16341225|NCT00335491|Procedure|physical therapy|12 weeks of 3x/week training on the eccentron
16341226|NCT00335478|Drug|Daptomycin|daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
16341227|NCT00335465|Drug|Insulin glargine|once a daily, sc injection, 100IU/ml
16341228|NCT00335452|Drug|Clopidogrel|oral administration
16341229|NCT00335452|Drug|acetylsalicyclic acid (ASA)|oral administration
16341230|NCT00335439|Drug|ketorolac tromethamine 0.5% (Acular®)|
16341231|NCT00335426|Procedure|Spinal manipulative therapy|
16341232|NCT00335413|Drug|Spironolactone|
16341233|NCT00335400|Drug|Anesthetic Dilating Gel|
16341234|NCT00335374|Drug|Pardoprunox|12 -42 mg
16341235|NCT00335361|Device|Intra Vas Device (IVD)|
16341236|NCT00335348|Drug|Bortezomib|Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks
16341237|NCT00335348|Drug|Dexamethasone|Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks
16341238|NCT00335335|Drug|iodixanol|
16341239|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)|Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
16341240|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)|Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
16341241|NCT00335322|Drug|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)|Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
16341242|NCT00335309|Procedure|Maxillary Sinus Irrigation|Twice a day irrigation with 100cc saline for 4 days
16341243|NCT00335309|Drug|IV Amoxicillin and Clavulanate acid|IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
16341244|NCT00335296|Device|PFx catheter|
16341245|NCT00335283|Drug|Lansoprazole Tablet|40 mg bid x 16 weeks
16341246|NCT00335283|Procedure|PH and impedence testing|24 hour ph monitoring
16341247|NCT00335283|Procedure|manometry|done prior to pH probe to measure length of esophagus
16341248|NCT00335283|Drug|lansoprazole|40mg bid
16341249|NCT00335283|Drug|placebo|one tablet bid
16341250|NCT00335270|Drug|fos-amprenavir calcium, ritonavir|
16341251|NCT00335270|Drug|abacavir/lamivudine as Epzicom|
16341252|NCT00335244|Drug|L-citrulline|150mg bolus X 1 after initiation of cardiopulmonary bypass followed by continuous infusion of 9mg/kg/hr IV, starting 4 hours post bolus administration and ending at 48 hours continuous infusion or discharge from the PCCU
16341253|NCT00335244|Drug|Placebo of intravenous L-citrulline|Placebo of intravenous L-citrulline
16341254|NCT00335231|Drug|gatifloxacin ophthalmic (ZYMAR)|
16341255|NCT00335218|Drug|Climodien / Lafamme (BAY86-5027)|1 tablet daily (2 mg EV + 2 mg DNG)
16341256|NCT00335218|Drug|Placebo|1 tablet daily
16341257|NCT00335205|Drug|ropinirole|
16341258|NCT00335192|Drug|Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks|3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)
16341259|NCT00335192|Drug|Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks|ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)
16341260|NCT00335192|Drug|Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks|3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h).
16341261|NCT00335179|Drug|Aldara (imiquimod 5% cream)|Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
16341262|NCT00335179|Drug|Vehicle cream|Vehicle cream in 250 mg
16341263|NCT00335166|Drug|Pardaprunox|12-42 mg
16341264|NCT00335166|Drug|pramipexole|1.5-4.5 mg
16341265|NCT00335166|Drug|Placebo Comparator|Placebo
16341266|NCT00335153|Drug|Levodopa-carbidopa intestinal gel|Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).
16341267|NCT00335153|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16341268|NCT00335153|Device|PEG tube|percutaneous endoscopic gastrostomy tube
16341269|NCT00335153|Device|J-tube|jejunal tube
16341270|NCT00335140|Biological|Rituximab|Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.
16341271|NCT00335140|Drug|Cytarabine|3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14
16341272|NCT00335140|Drug|Dexamethasone|16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6
16341273|NCT00335140|Drug|Leucovorin|25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10
16341274|NCT00335140|Drug|Methotrexate|"3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9
~For patients with meningeal involvement additionally:
~12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture"
16341275|NCT00335140|Drug|Procarbazine|100 mg/m2 PO daily x 7 days Weeks 1, 5, 9
16341276|NCT00335140|Drug|Vincristine|1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap
16341277|NCT00335114|Drug|cyclosporine ophthalmic emulsion|
16341278|NCT00335101|Drug|Iodixanol, Ioversol, Iopromide|
16341279|NCT00335088|Drug|Moxifloxacin and Povidone Iodine vs Povidone Iodine|
16341280|NCT00335075|Drug|Temozolomide|Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
16341281|NCT00335075|Drug|Semustine|Semustine orally once every 28 days at a dose of 150 mg/m2/day.
16341282|NCT00335049|Device|progressive addition spectacle lens (bifocal)|Progressive addition lenses (PAL) with a +2.00 D add.
16341283|NCT00335049|Device|Single Vision Lenses (SVLs)|Single vision spectacle lenses.
16341284|NCT00335036|Device|ICD lead implant|Randomization of ICD lead type at implant
16341285|NCT00335036|Device|Thin leads|Thin (less than or equal to 7 French introducer) isodiametric ICD leads
16341360|NCT00334672|Drug|etoposide|
16341286|NCT00335023|Other|Red blood cell transfusion|At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.
16341287|NCT00335010|Drug|Nitroglycerin|
16341288|NCT00334997|Procedure|endoscopic surgery|
16341289|NCT00334997|Procedure|laser surgery|
16341290|NCT00334997|Radiation|radiation therapy|
16341291|NCT00334984|Drug|glutamine|
16341292|NCT00334984|Procedure|chemoprotection|
16341293|NCT00334984|Procedure|management of therapy complications|
16341294|NCT00334984|Procedure|therapeutic nutritional supplementation|
16341295|NCT00334971|Procedure|Follicle Aspiration|Follicles will be aspirated using a transvaginal ultrasound guided needle.
16341296|NCT00334958|Drug|Placebo|For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.
16341297|NCT00334958|Drug|Rufinamide|For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
16341298|NCT00334932|Drug|bortezomib|
16341299|NCT00334932|Drug|melphalan|
16341300|NCT00334932|Drug|pegylated liposomal doxorubicin hydrochloride|
16341301|NCT00334919|Behavioral|Diet (Anti-Inflammatory or standard diabetic diet)|6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
16341302|NCT00334906|Drug|memantine HCl|
16341303|NCT00334893|Drug|eribulin mesylate|Given IV
16341304|NCT00334880|Drug|NRP104|
16341305|NCT00334867|Drug|cyclophosphamide|Given IV
16341306|NCT00334867|Drug|dexrazoxane hydrochloride|Given IV
16341307|NCT00334867|Drug|doxorubicin hydrochloride|Given IV
16341308|NCT00334867|Drug|etoposide|Given IV
16341309|NCT00334867|Drug|ifosfamide|Given IV
16341310|NCT00334867|Drug|topotecan hydrochloride|Given IV
16341311|NCT00334867|Drug|vincristine sulfate|Given IV
16341312|NCT00334867|Procedure|conventional surgery|Patients undergo surgery in week 18
16341313|NCT00334867|Procedure|radiation therapy|Patients undergo radiation therapy in week 19
16341314|NCT00334854|Drug|doxorubicin hydrochloride|
16341315|NCT00334854|Drug|ifosfamide|
16341316|NCT00334854|Procedure|adjuvant therapy|
16341317|NCT00334854|Procedure|conventional surgery|
16341318|NCT00334854|Procedure|neoadjuvant therapy|
16341319|NCT00334854|Radiation|radiation therapy|
16341320|NCT00334828|Drug|eritoran tetrasodium|Intravenous infusion at a total dose of 105 mg.
16341321|NCT00334828|Drug|Placebo|Matching placebo; intravenous infusion.
16341329|NCT00334802|Drug|gemcitabine|"Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
~Phase 2: dose determined by phase 1"
16341330|NCT00334802|Drug|paclitaxel|"Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
~Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles"
16341331|NCT00334789|Drug|Belinostat|Given IV
16341332|NCT00334789|Drug|Isotretinoin|Given orally
16341333|NCT00334789|Other|Pharmacological Study|Correlative studies
16341334|NCT00334776|Biological|MART-1 antigen|
16341335|NCT00334776|Biological|gp100:209-217(210M) peptide vaccine|
16341336|NCT00334776|Biological|therapeutic autologous dendritic cells|
16341337|NCT00334776|Biological|tyrosinase peptide|
16341338|NCT00334763|Biological|bevacizumab|
16341339|NCT00334763|Drug|carboplatin|
16341340|NCT00334763|Drug|chemoprotection|
16341341|NCT00334763|Drug|paclitaxel|
16341342|NCT00334763|Radiation|radiation therapy|
16341343|NCT00334750|Other|There is no intervention in this study.|This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada.
16341344|NCT00334737|Drug|Darbepoetin Alfa Injection|darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks
16341345|NCT00334737|Drug|erythropoietin alfa injection|Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation
16341346|NCT00334737|Drug|sham injection|sham injection other names: not applicable
16341347|NCT00334724|Procedure|Home blood pressure measurement|Blood pressure controlled based on home blood pressure measurement
16341348|NCT00334724|Procedure|Office blood pressure measurement|Blood pressure controlled based on office blood pressure measurement
16341349|NCT00334711|Drug|Sulfonylurea|
16341350|NCT00334698|Drug|Cetirizine|
16341351|NCT00334698|Drug|Pseudoephedrine|
16341352|NCT00334698|Drug|Cetirizine with Pseudoephedrine|
16341353|NCT00334685|Drug|[S,S]-Reboxetine + Pregabalin|[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
16341354|NCT00334685|Drug|Pregabalin|Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
16341355|NCT00334672|Biological|anti-thymocyte globulin|
16341356|NCT00334672|Drug|busulfan|
16341357|NCT00334672|Drug|cyclophosphamide|
16341358|NCT00334672|Drug|cyclosporine|
16341362|NCT00334672|Drug|mycophenolate mofetil|
16341363|NCT00334672|Drug|therapeutic hydrocortisone|
16341364|NCT00334672|Other|laboratory biomarker analysis|
16341365|NCT00334672|Procedure|allogeneic hematopoietic stem cell transplantation|
16341366|NCT00334672|Procedure|biopsy|
16341367|NCT00334659|Drug|apricitabine|
16341368|NCT00334646|Drug|Oral GW679769|150mg oral, once daily on days 1-3
16341369|NCT00334646|Drug|IV Cyclophosphamide 500-700mg/m2|IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle
16341370|NCT00334633|Drug|tinidazole, metronidazole|Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
16341371|NCT00334620|Procedure|15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation|
16341372|NCT00334607|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
16341373|NCT00334594|Drug|Cisplatin|Cisplatin 75 mg/m2 i.v. over approximately 2 hours on day 1 every 21 days
16341374|NCT00334594|Drug|Pemetrexed|Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days
16341375|NCT00334594|Procedure|Therapeutic conventional surgery|Extrapleural pneumonectomy
16341376|NCT00334594|Radiation|Radiotherapy|CTV1 will receive 45 or 46 Gy. CTV2 will be treated up to a total dose of 55,9 to 56,2 Gy.
16341377|NCT00334581|Drug|Irbesartan|Administration throughout the study period
16341378|NCT00334581|Drug|Irbesartan|Administration throughout the study period
16341379|NCT00334568|Drug|Rosiglitazone XR (extended release) oral tablets|Rosi XR tablets
16341380|NCT00334568|Drug|Placebo|Placebo
16341381|NCT00334555|Other|different methods of partner notification|comparing patient referral, partner delivered medications and field intervention to treat sex partners
16341382|NCT00334555|Other|partner delivered meds|patient given meds to give to her partner
16341383|NCT00334555|Other|field intervention|health worker finds partners
16341384|NCT00334542|Drug|simvastatin|24-28 weeks of simvastatin
16341385|NCT00334529|Drug|Oseltamivir|
16341386|NCT00334503|Drug|Miglitol|
16341387|NCT00334490|Drug|Sildenafil|12.5 mg Sildenafil once with optional second dose
16341388|NCT00334490|Drug|Sildenafil|12.5 mg orally once with optional second dose
16341389|NCT00334490|Drug|Placebo|Oral Placebo in 5 mls distilled water
16341390|NCT00334477|Drug|tadalafil|
16341391|NCT00334464|Drug|Standard of care or genotyping dosing of warfarin dosing|
16341392|NCT00334438|Biological|rituximab|250mg/m2, IV, Days 1 and 8
16341393|NCT00334438|Drug|bortezomib|dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
16341394|NCT00334438|Radiation|yttrium Y 90 ibritumomab tiuxetan|Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
16341395|NCT00334438|Radiation|Indium 111 ibritumomab tiuxetan|5cmCi; IV day 1
16341396|NCT00334425|Drug|MENOPUR; GONAL-F|
16341397|NCT00334412|Drug|Ambisome|
16341398|NCT00334412|Drug|caspofungin|
16341399|NCT00334399|Drug|Miglitol|
16341400|NCT00334386|Drug|Torasemide Prolonged Release (loop diuretic)|
16341401|NCT00334386|Drug|Torasemide Immediate Release (loop diuretic)|
16341402|NCT00334373|Procedure|Post conditioning|4 cycles of balloon inflation /deflation (post-conditioning) within first minute of opening up artery in primary PCI for STEMI vs usual balloon inflation sequence
16341403|NCT00334360|Drug|dexmedetomidine|Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
16341404|NCT00334360|Drug|buspirone|Buspirone, 60 mg orally, will be given during controlled hypothermia.
16341405|NCT00334360|Drug|Bus and Dex|the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
16341406|NCT00334360|Drug|Control|No drugs given during controlled hypothermia
16341407|NCT00334347|Drug|Depakote ER|The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
16341408|NCT00334347|Drug|Depakote DR|The starting doses will be 25 mg/kg and 20 mg/kg. The dose you get will depend on how much you weigh.
16341409|NCT00334334|Biological|Pneumococcal (vaccine)|
16341410|NCT00334321|Radiation|IMRT|
16341411|NCT00334321|Radiation|Intracavitary vaginal brachytherapy|
16341412|NCT00334321|Drug|Paclitaxel|
16341413|NCT00334321|Drug|Carboplatin|
16341414|NCT00334308|Procedure|Barley protein bread or control (casein) bread|
16341415|NCT00334295|Drug|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
16341416|NCT00334282|Drug|Pazopanib|Oral pazopanib tablet 800 mg once daily continuously
16341417|NCT00334282|Drug|placebo|matching placebo (800 mg tablet) once daily
16341418|NCT00334269|Behavioral|Health messaging at weekly home visits by health counsellor|
16341419|NCT00334269|Behavioral|Weekly home delivery of bottled spring water|
16341420|NCT00334269|Behavioral|Weekly afterschool physical activity program for 5-18y.o.|
16341421|NCT00334269|Behavioral|Cooking classes and grocery store tours with dietician|
16341422|NCT00334269|Behavioral|Pedometers to track/increase weekly physical activity|
16341423|NCT00334256|Drug|Tenofovir (TDF)|
16341424|NCT00334256|Drug|Emtricitabine (FTC)|
16341425|NCT00334243|Drug|Microflare protocol for IVF|
16341426|NCT00334243|Drug|Antagonist protocol for IVF|
16341427|NCT00334243|Drug|Demi-halt protocol for IVF|
16341428|NCT00334217|Behavioral|Cognitive Remediation|PSS Cogrehab
16341429|NCT00334204|Device|measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy|measuring Platelet Function Analyser (PFA) -100 platelet function before kidney biopsy
16341430|NCT00334191|Drug|Sodium Bicarbonate|
16341431|NCT00334191|Drug|Placebo|
16341432|NCT00334178|Drug|Laxymig ER (drug)|
16341433|NCT00334165|Procedure|Auricular acupuncture (procedure)|
16341434|NCT00334152|Drug|casopitant|
16341435|NCT00334139|Drug|Zoledronic Acid|every 4 weeks for 4 months
16341436|NCT00334126|Drug|paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulated|
16341437|NCT00334113|Behavioral|TLC-PED|Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
16341438|NCT00334100|Behavioral|Exercise|Treadmill exercise
16341439|NCT00334087|Behavioral|feeding habits|
16341440|NCT00334074|Drug|Clofarabine and Cytarabine|Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity
16341441|NCT00334061|Device|Penumbra System|
16341442|NCT00334048|Drug|Ropinirole (Requip)|1 mg extended release formulation given once per day to a maximum of 4 per day
16341443|NCT00334035|Drug|Quetiapine|
16341444|NCT00334022|Drug|enfuvirtide|1ml BID
16341445|NCT00333996|Drug|Dexamethasone|
16341446|NCT00333983|Device|Robotic Upper Extremity Neurorehabilitation|Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
16341447|NCT00333983|Other|Traditional Upper Extremity Exercise Group|Upper extremity stretching, skateboard reaching activities, and arm ergometer
16341448|NCT00333970|Behavioral|cognitive remediation|individual cognitive training
16341449|NCT00333944|Drug|Pralidoxime(drug)|
16341450|NCT00333931|Drug|Phenytoin|
16341451|NCT00333931|Behavioral|Cognitive Behavioral Therapy|
16341452|NCT00333918|Drug|bromfenac ophthalmic solution|
16341453|NCT00333918|Drug|placebo comparator|
16341454|NCT00333905|Procedure|Ischemic exercise training|
16341455|NCT00333892|Procedure|leukapheresis|pack of cells as per protocol
16341456|NCT00333879|Device|Virtual Sound System|Virtual Sound System is tested for efficacy in its ability to realistically simulate Street Crossings sounds in a safe indoor environment. If efficacious, Blind students will be able to practice crossing streets in safety indoors.
16341457|NCT00333866|Drug|pregabalin|600mg/day
16341458|NCT00333866|Drug|pregabalin|450mg/day
16341459|NCT00333866|Drug|pregabalin|300mg/day
16341460|NCT00333866|Drug|placebo|placebo
16341461|NCT00333853|Device|OneTouch(r) UltraSmart(r)|
16341462|NCT00333840|Drug|imatinib mesilate|imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
16341463|NCT00333840|Drug|interferon-alpha (INF-a)|interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day.
16341464|NCT00333840|Drug|cytarabine (ARA-C)|cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.
16341465|NCT00333827|Drug|optimal therapy for cardiaca failure|optimal therapy for cardiaca failure
16341466|NCT00333827|Procedure|cell|stem cell
16341467|NCT00333814|Drug|Dexamethasone|Dexamethasone 350 µg; injection drug delivery system at Day 0
16341468|NCT00333814|Drug|dexamethasone|Dexamethasone 700 µg injection drug delivery system at Day 0
16341469|NCT00333814|Drug|Sham injection|Sham injection at Day 0
16341470|NCT00333801|Behavioral|Vocational Rehabilitation Program (VRP)|Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
16341471|NCT00333801|Behavioral|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team.
16341472|NCT00333788|Biological|Certolizumab pegol (CDP870)|400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
16341473|NCT00333775|Drug|Docetaxel|Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
16341474|NCT00333775|Drug|Placebo to bevacizumab|Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
16341475|NCT00333775|Drug|Bevacizumab|Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
16341476|NCT00333762|Device|Smart Power Assistance Module (SPAM)|Experimental Power wheelchair utilized to traverse prescribed course
16341477|NCT00333762|Device|Smart Wheelchair Component System (SWCS)|Experimental power wheelchair utilized to traverse prescribed course
16341478|NCT00333749|Biological|Drinking or rinsing the mouth 2-3 times for 1 day|
16341479|NCT00333749|Biological|Pasturlized cow milk|Drinking or rinsing the mouth 2-3 times for one day.
16341480|NCT00333736|Device|Biojector|All patients received biojector to use with BID enfuvirtide doses
16341481|NCT00333723|Drug|Rosiglitazone|
16341482|NCT00333710|Behavioral|Individual psychotherapy|Individual face-to-face contact with educational and goal setting components
16341483|NCT00333710|Behavioral|Telehealth Intervention|Individual telephone contact with educational and goal setting components
16341484|NCT00333697|Other|Comprehensive Duplex Ultrasound (diagnostic study)|A sigle duplex ultrasound examination of the deep venous system of the leg(s) suspected of deep vein thrombosis. Deep veins of the leg are examined for evidence of thrombosis from the inguinal ligament to the level of the malleolus.
16341485|NCT00333684|Device|BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS|prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
16341486|NCT00333671|Drug|Glycerol|
16341487|NCT00333658|Behavioral|Goal setting and work feedback group|Goal setting and feedback using WBI
16341488|NCT00333645|Drug|Caspofungin|
16341489|NCT00333632|Drug|Dexmedetomidine|
16341490|NCT00333632|Drug|Propofol|
16341491|NCT00333632|Drug|Midazolam|
16341492|NCT00333632|Drug|Fentanyl|
16341493|NCT00333632|Drug|Isoflurane|
16341494|NCT00333619|Behavioral|Nonpharmacological sleep intervention|The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
16341495|NCT00333619|Behavioral|Active control|Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
16341496|NCT00333606|Behavioral|Acupuncture|Body acupuncture of 1 specific point per trial session
16341497|NCT00333593|Device|Large pore dialyser|
16341498|NCT00333593|Device|Standard dialyser|
16341499|NCT00333567|Drug|Lumiracoxib|
16341500|NCT00333554|Dietary Supplement|DHA Treatment|DHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food) depending on age of child.
16341501|NCT00333554|Dietary Supplement|Placebo for DHA|Study placebo given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child.
16341502|NCT00333541|Behavioral|Using internet/E-mail for follow-up|follow-up via email link to survey
16341503|NCT00333528|Drug|Human butyrylcholinesterase (HuBChE) derived from human plasma|Intramuscular administration
16341504|NCT00333528|Drug|Placebo: Normal saline|Intramuscular administration
16341505|NCT00333515|Drug|Human Butyrylcholinesterase (HuBChE) derived from human plasma|Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
16341506|NCT00333515|Drug|Placebo: Normal saline|Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
16341507|NCT00333502|Drug|Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer|Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.
16341508|NCT00333489|Drug|valsartan|
16341509|NCT00333476|Drug|MSI-1256F (Squalamine Lactate)|
16341510|NCT00333463|Behavioral|Intervention|The intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices.
16341511|NCT00333450|Biological|Pneumococcal vaccine|
16341512|NCT00333437|Drug|Mycophenolate mofetil|
16341513|NCT00333424|Biological|pHIS-HIV-AE (DNA vaccine) prime and rFPV-HIV-AE (recombinant fowlpox virus boost) vaccine|6mg pHIS-HIV-AE at weeks 0, 4 and 8; 3 x 10e8 pfu/mL rFPV-HIV-AE at week 12
16341514|NCT00333411|Drug|BIRT 2584 XX|
16341515|NCT00333411|Drug|Placebo|
16341516|NCT00333398|Biological|CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free|CSL influenza vaccine-prefilled syringe presentation (thimerosal-free) 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
16341517|NCT00333398|Biological|CSL Trivalent Inactivated Influenza Vaccine with Thimerosal|CSL influenza vaccine-multiple dose vial presentation (thimerosal-containing) containing 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
16341518|NCT00333398|Biological|Placebo with Thimerosal|Phosphate buffered isotonic saline solution containing thimerosal. Single dose of 0.5 mL administered on study day 0.
16341519|NCT00333385|Drug|ceftazidime|
16341520|NCT00333372|Drug|Z-338|
16341521|NCT00333359|Drug|XP13512 (GEn)|1200 mg XP13512, orally, once daily for 52 weeks
16341522|NCT00333346|Drug|Administration of tramadol intravenously|
16341523|NCT00333333|Procedure|Cord blood|Cord blood will be obtained at the time of delivery.
16341524|NCT00333320|Procedure|postconditioning|patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
16341525|NCT00333320|Procedure|Control group|Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
16341526|NCT00333307|Drug|recombinant human relaxin|
16341527|NCT00333294|Drug|Gefitinib|
16341528|NCT00333294|Procedure|Radiation therapy|
16341529|NCT00333294|Drug|Cisplatin|
16341530|NCT00333294|Drug|Vinorelbine|
16341531|NCT00333281|Drug|tadalafil|
16341532|NCT00333268|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
16341533|NCT00333268|Drug|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
16341534|NCT00333255|Drug|Nepafenac Ophthalmic Suspension, 0.1%|
16341535|NCT00333242|Drug|dextromethorphan|dextromethorphan PO titrated to 480 mg/day x 5 weeks
16341536|NCT00333229|Drug|Zoledronic Acid|4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
16341537|NCT00333229|Drug|Placebo|Matching Placebo
16341538|NCT00333216|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Posterior juxtascleral administration of suspension
16341539|NCT00333216|Drug|Anecortave Acetate Sterile Suspension, 60 mg/ML|Posterior juxtascleral administration of suspension
16341540|NCT00333216|Other|Anecortave Acetate Vehicle|Sham posterior juxtascleral administration of suspension
16341541|NCT00333203|Drug|Next Generation Ophthalmic Irrigating Solution (NGOIS)|Volume sufficient to irrigate adequately during cataract surgery
16341542|NCT00333203|Other|BSS Plus|Volume sufficient to irrigate adequately during cataract surgery
16341543|NCT00333190|Device|CD+8 T cell depletion|CD8 depleted product Given through central line after treatment with fludarabine and busulfex intravenously for 4 days
16341544|NCT00333177|Behavioral|Cognitive remediation training (CT)|Cognitive remediation training includes computerized cognitive training plus learning skills group.
16341545|NCT00333177|Behavioral|Healthy behavior training (HBT)|Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.
16341546|NCT00333177|Drug|Risperidone, administered orally (Oral Ris)|Oral risperidone at dosage judged optimal by treating psychiatrist
16341547|NCT00333177|Drug|Risperidone, administered via injection (RLAI)|Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
16341548|NCT00333164|Drug|Asprin, Cilostazol|
16341549|NCT00333151|Drug|liraglutide|
16341550|NCT00333151|Drug|rosiglitazone|
16341551|NCT00333151|Drug|metformin|
16341552|NCT00333138|Drug|FTY720|FTY720 capsule was taken orally once a day
16341553|NCT00333138|Drug|Placebo|Placebo 1.25 mg capsule was given once daily
16341554|NCT00333125|Drug|Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)|One drop in the study eye(s) once daily, 9 PM, for 6 weeks
16341555|NCT00333125|Drug|Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)|One drop in the study eye(s) twice daily for 6 weeks
16341556|NCT00333125|Other|Timolol Vehicle|One drop in the study eye(s) once daily for 6 weeks
16341557|NCT00333112|Drug|solifenacin succinate|Oral
16341558|NCT00333112|Drug|tamsulosin|oral
16341559|NCT00333112|Drug|placebo|oral
16341560|NCT00333099|Dietary Supplement|Impact (R) Enteral Nutrition|mucositis frequency, treatment tolerance
16341561|NCT00333099|Other|impact|"1500 calories every day :
~-5 days before the begining of the chemoradiotherapy and until the last day of the treatment"
16341562|NCT00333086|Drug|Letrozole|
16341563|NCT00333073|Device|Bulkamid|initial injection with option for second (if required)
16341564|NCT00333060|Drug|OT-551 ophthalmic solution|
16341565|NCT00333047|Drug|Letrozole|
16341566|NCT00333034|Drug|Etanercept|
16341567|NCT00333021|Drug|Fondaparinux sodium|
16341568|NCT00333021|Drug|GSK576428|
16341569|NCT00333008|Drug|Doxil|
16341570|NCT00333008|Drug|Cyclophosphamide|
16341571|NCT00333008|Drug|Vincristine|
16341572|NCT00333008|Drug|Prednisone|
16341573|NCT00333008|Drug|Rituximab|
16341574|NCT00333008|Drug|Pegfilgrastim|
16341575|NCT00332995|Drug|dapivirine (TMC120) vaginal ring|
16341576|NCT00332982|Behavioral|Focused knowledge translation strategies|
16341577|NCT00332969|Drug|Octreotide|
16341578|NCT00332956|Biological|rFIV vaccine|rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
16341579|NCT00332956|Biological|rF1V vaccine|rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
16341580|NCT00332956|Biological|rF1V vaccine|rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
16341581|NCT00332956|Biological|rF1V vaccine 160 mcg given on Study Days 0, 56, 182|rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
16341582|NCT00332943|Procedure|MR colonography with fecal tagging|
16341583|NCT00332930|Biological|recombinant fowlpoxvirus (rFPV) expressing HIV gag-pol antigens|
16341584|NCT00332930|Biological|HIV gag-pol antigens and interferon-gamma (IFN-y)|
16341585|NCT00332917|Drug|Pardoprunox|12-42 mg
16341586|NCT00332904|Drug|propranolol|tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
16341587|NCT00332904|Drug|spironolactone|tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
16341588|NCT00332891|Drug|SR58611A|
16341589|NCT00332878|Behavioral|Stepping Stones|a comprehensive sexual and reproductive health promotion programme lasting about 50 hours comprising 13 content sessions of about 3 hours duration and 4 meetings of peer groups
16341590|NCT00332878|Behavioral|stepping Stones short|3 hour intervention on HIV and safer sex
16341591|NCT00332865|Behavioral|Swallowing Exercises|Daily exercises
16341592|NCT00332852|Drug|Letrozole|2.5 mg/day - oraly
16341593|NCT00332839|Drug|Everolimus|Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).
16341594|NCT00332839|Drug|Cyclosporin A (CsA)|The dose was based on the participants' blood level of C0h (80-150 ng/ml).
16341595|NCT00332839|Drug|Tacrolimus|The dose was based on the participants' blood level of C0h (5-10 ng/ml).
16341596|NCT00332839|Drug|Enteric Coated - Mycophenolate Sodium (EC-MPS)|The dose was ≥ 720 mg/day.
16341597|NCT00332839|Drug|Corticosteroids|Corticosteroids were given according to local standard and/or the Investigators' discretion.
16341598|NCT00332826|Drug|Technosphere Insulin|
16341599|NCT00332813|Behavioral|HIV Risk Behavior Intervention|
16341600|NCT00332800|Drug|Nutritional Supplementation|
16341601|NCT00332787|Drug|Fluoxetine|
16341602|NCT00332774|Drug|Nepafenac ophthalmic solution 0.1%|1 drop 4 times daily for 90 days
16341603|NCT00332774|Drug|Ketorolac Tromethamine ophthalmic solution 0.4%|1 drop 4 times daily for 90 days
16341604|NCT00332774|Other|Nepafenac ophthalmic suspension vehicle|
16341605|NCT00332761|Drug|Caduet|
16341606|NCT00332748|Drug|Oral Taxane|
16341607|NCT00332735|Drug|spinal administration of articaine|
16341608|NCT00332735|Drug|spinal administration of bupivacaine|
16341609|NCT00332722|Procedure|Cervical facet joint nerve blocks|
16341610|NCT00332709|Drug|Letrozole|2.5 mg/day for 3 years
16341611|NCT00332709|Drug|Zoledronic acid|4 mg every 6 months
16341612|NCT00332696|Drug|Octreotide LAR|Octreotide long-acting release (LAR) 30 mg intramuscular injection.
16341613|NCT00332696|Drug|Octreotide (Immediate release)|Immediate-release Octreotide supplied in 100 µg/mL ampules.
16341614|NCT00332696|Drug|methylprednisolone|methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
16341615|NCT00332696|Drug|Placebo|Physiologic saline solution
16341616|NCT00332683|Procedure|Maintaining low (15mmHg) ETT cuff pressure|Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
16341617|NCT00332683|Procedure|Maintaining a normal pressure in the ETT cuff|No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
16341618|NCT00332670|Procedure|10.000lux blue 1 hour every day during three weeks|10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks
16341619|NCT00332670|Procedure|50lux dim red 1 hour every day during three weeks|50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks
16341620|NCT00332657|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|One 0.5 mL injection into the PJD at 6-month intervals for 42 months
16341621|NCT00332657|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL injection into the PJD at 6-month intervals for 42 months
16341742|NCT00331604|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
16341622|NCT00332657|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
16341623|NCT00332644|Drug|nicotine patch|used according to FDA package label
16341624|NCT00332644|Drug|nicotine lozenge|used according to FDA-approved package directions
16341625|NCT00332644|Drug|nicotine patch + nicotine lozenge|dosage of both according to FDA-approved dosing schedule
16341626|NCT00332644|Drug|bupropion|dosage according to FDA-approved instructions
16341627|NCT00332644|Drug|bupropion + lozenge|dosage according to FDA approved standard instructions
16341628|NCT00332644|Drug|placebo|dosage same as active drug conditions
16341629|NCT00332631|Drug|N-acetylcysteine|
16341630|NCT00332631|Drug|Placebo|
16341631|NCT00332618|Device|OXYGENATED GLYCEROL TRIESTERS|
16341632|NCT00332605|Drug|Naltrexone plus N-Acetyl Cysteine|daily
16341633|NCT00332605|Drug|Placebo|daily
16341634|NCT00332579|Drug|Naltrexone|daily
16341635|NCT00332579|Drug|Placebo|daily
16341636|NCT00332566|Biological|DTPw-HBV/Hib Kft vaccine GSK323527A|Intramuscular injection, 1 dose
16341637|NCT00332566|Biological|Tritanrix™-HepB/Hiberix™|Intramuscular injection, 1 dose
16341638|NCT00332553|Drug|Raloxifene|
16341639|NCT00332553|Drug|medroxyprogesterone acetate|
16341640|NCT00332553|Drug|estrogen|
16341641|NCT00332553|Drug|17 beta estradiol|
16341642|NCT00332540|Drug|bimatoprost/timolol fixed combination|
16341643|NCT00332514|Behavioral|telephone call by a pharmacist|
16341644|NCT00332488|Drug|Technosphere Insulin|Inhalation, 15U/30U, prandial
16341645|NCT00332488|Drug|Metformin & Secretagogues|Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
16341646|NCT00332488|Drug|Technosphere Insulin & Metformin|Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
16341647|NCT00332462|Drug|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
16341648|NCT00332462|Drug|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
16341649|NCT00332436|Drug|brimonidine/timolol fixed combination|
16341650|NCT00332397|Device|Rapamycin-eluting Stent|due to randomization, Cypher stent will be implanted
16341651|NCT00332397|Device|Zotarolimus-eluting Stent|due to randomization, Endeavor stent will be implanted
16341652|NCT00332397|Device|Rapamycin-eluting Stent|due to randomization, rapamycin-eluting stent will be implanted
16341653|NCT00332384|Drug|brimonidine/timolol fixed combination|
16341654|NCT00332371|Device|CPFA (Coupled Plasma Filtration Adsorption)|"CPFA is a specific method for the treatment of sepsis.
~It consists of:
~a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa)
~a hemofilter (polyethersulfone 1,4 m2)
~a cartridge (contains approximately 140 ml of hydrophobic styrenic resin)
~The kit is lodged in the Bellco Lynda machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter."
16341655|NCT00332345|Drug|brimonidine/timolol fixed combination|
16341656|NCT00332332|Biological|etanercept|etanercept subcutaneous injection
16341657|NCT00332319|Drug|GW679769|
16341658|NCT00332306|Drug|Didanosine, Lamivudine, Efavirenz|Didanosine 250mg patients <60kg, 400mg patients > 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months
16341659|NCT00332306|Drug|Didanosine, Lamivudine, Nevirapine|Didanosine 250 mg once daily for patients < 60kg, 400 mg OD patients > 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months
16341660|NCT00332293|Drug|Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%|1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
16341661|NCT00332293|Drug|Moxifloxacin hydrochloride ophthalmic solution 0.5% as base|1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
16341662|NCT00332280|Drug|AMT2003|
16341663|NCT00332267|Procedure|Endotoxin infusion, Normobaric hypoxia|
16341664|NCT00332254|Drug|Anakinra|150 mg IL1Ra ia x1 vs saline ia x1
16341665|NCT00332241|Drug|Aripiprazole|Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
16341666|NCT00332241|Drug|Placebo|Tablets, Oral, once daily, 8 weeks
16341667|NCT00332228|Drug|depot naltrexone|long-acting depot parenteral formulation of naltrexone
16341668|NCT00332228|Behavioral|Compliance enhancement (CE)|Compliance enhancement (CE), simulating standard treatment with oral naltrexone
16341669|NCT00332228|Drug|BNT|behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction
16341670|NCT00332215|Drug|Inhaled Sodium Pyruvate|
16341671|NCT00332202|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
16341672|NCT00332202|Drug|placebo|oral, daily
16341673|NCT00332189|Drug|sapropterin dihydrochloride|5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.
16341674|NCT00332176|Drug|Celgosivir|400mg qd + standard of care for 12 weeks
16341675|NCT00332176|Drug|Celgosivir|600mg qd + standard of care for 12 weeks
16341676|NCT00332176|Drug|Peginterferon alfa 2b + ribavirin|Standard of care for 12 weeks
16341677|NCT00332163|Biological|Panitumumab|Administered by intravenous infusion
16341678|NCT00332163|Drug|Irinotecan|Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines.
16341679|NCT00332163|Drug|FOLFIRI|Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
16341743|NCT00331604|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c. After 2 years.
16341744|NCT00331578|Device|Excel drug-eluting coronary artery stent|
16341680|NCT00332163|Drug|Pre-emptive Skin Treatment|Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).
16341681|NCT00332163|Drug|Reactive Skin Treatment|Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)
16341682|NCT00332137|Drug|Tolterodine|
16341683|NCT00332124|Drug|Choline|900 mg every day until birth of infant
16341684|NCT00332124|Dietary Supplement|Placebo|Corn oil every day in place of choline
16341685|NCT00332098|Behavioral|Family-Focused Treatment Plus Pharmacotherapy|Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed.
16341686|NCT00332098|Behavioral|Enhanced Care Plus Pharmacotherapy|Participants assigned to Enhanced Care will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FFT participants.
16341687|NCT00332085|Drug|Chromium Picolinate|
16341688|NCT00332072|Drug|bimatoprost/timolol fixed combination|
16341689|NCT00332059|Drug|bimatoprost/timolol fixed combination|
16341690|NCT00332046|Drug|GW679769|
16341691|NCT00332033|Drug|Pirfenidone|
16341692|NCT00332020|Drug|Rivaroxaban (BAY59-7939)|10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
16341693|NCT00332020|Drug|Enoxaparin|40 mg enoxaparin syringe administered for 12 +/- 2 days
16341694|NCT00332007|Drug|Tonabersat|two tablets once daily
16341695|NCT00332007|Drug|Placebo|two tablets once daily
16341696|NCT00331994|Drug|Bacillus clausii|3 bacillus clausii vials/day for one month
16341697|NCT00331994|Drug|Metronidazole|3 Metronidazole tablets/day for one week
16341698|NCT00331981|Drug|Amisulpride|
16341699|NCT00331955|Drug|doxorubicin hydrochloride|Given IV
16341700|NCT00331955|Drug|vorinostat|Given orally
16341701|NCT00331955|Other|pharmacological study|Correlative studies
16341702|NCT00331955|Other|laboratory biomarker analysis|Correlative studies
16341703|NCT00331929|Device|Minato A 500 AS spirometer|Spirometry at rest
16341704|NCT00331916|Drug|quinolone|
16341705|NCT00331890|Drug|Citicoline|1g/12h iv during 3 days and then orally until complete 6 weeks of treatment
16341706|NCT00331890|Drug|Placebo|As active drug
16341707|NCT00331877|Procedure|family conference with bereavement information leaflet|
16341708|NCT00331864|Drug|Ranibizumab|
16341709|NCT00331851|Drug|liraglutide|
16341710|NCT00331851|Drug|insulin glargine|
16341711|NCT00331851|Drug|metformin|
16341712|NCT00331851|Drug|glimepiride|
16341713|NCT00331838|Drug|Semuloparin sodium|"0.8 mL solution in Type I amber glass vials
~Subcutaneous injection"
16341714|NCT00331838|Drug|Placebo (for Enoxaparin sodium)|"0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection"
16341715|NCT00331838|Drug|Enoxaparin sodium|"0.4 mL solution in ready-to-use pre-filled syringe
~Subcutaneous injection"
16341716|NCT00331838|Drug|Placebo (for Semuloparin sodium)|"0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component
~Subcutaneous injection"
16341717|NCT00331825|Drug|Risperidone and Olanzapine|
16341718|NCT00331812|Procedure|Mitochondrial functions and oxidative stress|
16341719|NCT00331799|Drug|Duloxetine|Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
16341720|NCT00331786|Drug|nitric oxide-releasing acetylsalicylic acid derivative|
16341721|NCT00331786|Other|laboratory biomarker analysis|
16341722|NCT00331786|Procedure|biopsy|
16341723|NCT00331773|Radiation|Conventional 3D-CRT or IMRT|Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
16341724|NCT00331773|Radiation|Hypofractionated 3D-CRT or IMRT|Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
16341725|NCT00331760|Drug|cisplatin|
16341726|NCT00331760|Radiation|intensity-modulated radiation therapy|
16341727|NCT00331747|Drug|Glatiramer acetate|
16341728|NCT00331721|Drug|Enecadin|Dose escalating
16341729|NCT00331721|Drug|Placebo|Placebo comparator
16341730|NCT00331708|Drug|Artesunate plus sulfadoxine-pyrimethamine|
16341731|NCT00331695|Drug|17 alpha-hydroxyprogesterones caproate|17 alpha-hydroxyprogesterones caproate
16341732|NCT00331682|Drug|alvocidib|Given IV
16341733|NCT00331682|Drug|docetaxel|Given IV
16341734|NCT00331669|Procedure|deep brain stimulation|high frequency stimulation
16341735|NCT00331656|Device|Non-invasive positive pressure mask ventilators|
16341736|NCT00331656|Device|Extrathoracic biphasic cuirass ventilator (RTX, Hayek)|
16341737|NCT00331643|Drug|ixabepilone|Given IV
16341738|NCT00331630|Drug|lapatinib ditosylate|Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16341739|NCT00331630|Drug|paclitaxel albumin-stabilized nanoparticle formulation|30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16341740|NCT00331604|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16341741|NCT00331604|Drug|insulin detemir|Injection s.c., 50% of daily dose.
16342562|NCT00324662|Device|Implantable cardioverter-defibrillator|
16341745|NCT00331565|Procedure|Bariatric surgery|Gastric bypass, duodenal switch and sleeve surgery
16341746|NCT00331552|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16341747|NCT00331552|Drug|cyclophosphamide|Given orally
16341748|NCT00331552|Biological|trastuzumab|Given IV
16341749|NCT00331539|Device|Cochlear Implant|
16341750|NCT00331526|Biological|aldesleukin|
16341751|NCT00331526|Biological|therapeutic autologous lymphocytes|
16341752|NCT00331526|Procedure|adjuvant therapy|
16341753|NCT00331526|Procedure|conventional surgery|
16341754|NCT00331513|Drug|vorinostat|Given orally
16341755|NCT00331513|Drug|idarubicin|Given IV
16341756|NCT00331513|Other|laboratory biomarker analysis|Correlative studies
16341757|NCT00331513|Other|pharmacological study|Correlative studies
16341758|NCT00331500|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%|
16341759|NCT00331500|Drug|Olopatadine Hydrochloride Ophthalmic Solution Vehicle|Inactive ingredients used as a placebo comparator
16341760|NCT00331487|Drug|Pioglitazone|Pioglitazone 30 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to pioglitazone 45 mg, capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks
16341761|NCT00331487|Drug|Rosiglitazone|Rosiglitazone 4 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to rosiglitazone 4 mg, capsules, orally, twice daily for up to 12 weeks
16341762|NCT00331474|Biological|BCG delayed|early (birth) and delayed (14 weeks) intradermal BCG vaccination
16341763|NCT00331435|Procedure|Ocular photodynamic therapy with verteporfin|Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds
16341764|NCT00331422|Drug|carboplatin|Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.
16341765|NCT00331422|Drug|paclitaxel|Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.
16341766|NCT00331422|Procedure|cytoreductive surgery|Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis
16341767|NCT00331409|Drug|Everolimus|2.5 mg by mouth daily
16341768|NCT00331409|Drug|imatinib mesylate|600 mg by mouth daily
16341769|NCT00331370|Behavioral|GP training and Health Education|
16341770|NCT00331344|Drug|mitoxantrone hydrochloride|Given IV
16341771|NCT00331344|Drug|ixabepilone|Given IV
16341772|NCT00331344|Drug|prednisone|Given orally
16341773|NCT00331305|Behavioral|Supervised Exercise|
16341774|NCT00331305|Behavioral|Home-Based Exercise|
16341775|NCT00331305|Drug|Sertraline (Zoloft)|
16341776|NCT00331305|Drug|Placebo Pill|
16341777|NCT00331279|Drug|Oral Cinnamon Extract|A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
16341778|NCT00331279|Drug|Placebo|Placebo pills in likeness of the cinnamon extract
16341779|NCT00331253|Procedure|Indocyanine Green-Mediated Photothrombosis|
16341780|NCT00331240|Drug|travoprost/timolol fixed combination|
16341781|NCT00331240|Drug|placebo (artificial tears)|
16341782|NCT00331227|Drug|Isotonix OPC-3 (flavonoid supplement)|
16341783|NCT00331214|Drug|Testosterone Transdermal System|testosterone patch (300 mcg/day), patch changed twice a week for six months
16341784|NCT00331214|Drug|placebo patch|placebo patch replaced every 3-4 days for 6 months
16341785|NCT00331201|Drug|SAFEstart|
16341786|NCT00331188|Drug|Sanvar® (vapreotide)|
16341787|NCT00331175|Drug|Peptide YY3-36|
16341788|NCT00331162|Drug|Alemtuzumab|30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
16341789|NCT00331162|Drug|Anti-Thymocyte Globulin|"1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr < 3-4 mg/dL.
~Give first dose over 6 hours, subsequent doses over 4 hours.
~Premedication to be given with the first 3 doses:
~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.
~Hold infusion if temperature > 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"
16341790|NCT00331149|Drug|Ropinirole prolonged release|
16341791|NCT00331149|Drug|ropinirole immediate release|
16341792|NCT00331136|Drug|Pyronaridine-Artesunate|once a day for 3 days
16341793|NCT00331123|Drug|Testosterone Transdermal System|testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks
16341794|NCT00331123|Drug|Placebo|placebo patch,changed every 3-4 days for 24 weeks during double blind phase
16341795|NCT00331110|Device|Laterally-Wedged Insole with Ankle Strapping|
16341796|NCT00331110|Device|Laterally-Weged Insole|
16341797|NCT00331097|Drug|docetaxel|35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
16341798|NCT00331097|Drug|cyclophosphamide|600 mg/m2 intravenously days 1, 8 every 28 days
16341799|NCT00331097|Drug|methotrexate|40 mg/m2 intravenously days 1 and 8 every 28 days
16341800|NCT00331097|Drug|5-fluorouracil|600 mg/m2 intravenously days 1 and 8 every 28 days
16341801|NCT00331084|Drug|antibiotic/steroid combination|1 gtt, 4x/day, 15 days
16341802|NCT00331084|Drug|moxifloxacin / dexamethasone|1 gtt 4x/day, 15 days
16341803|NCT00331071|Drug|Monophasic or triphasic Oral contraceptive tablet|fourth week is patch free
16341804|NCT00331071|Drug|Ortho Evra transdermal patch containing 6 mg NGMN/0.75 mg EE|worn for 1 week and replaced for 3 consecutive weeks
16341805|NCT00331058|Procedure|Bronchoscopsy|Healthy and Asthmatic Volunteers
16341806|NCT00331058|Procedure|Prednisolone|Asthmatic Volunteers
16341807|NCT00331045|Drug|alvimopan|0.25 mg/day
16341808|NCT00331045|Drug|Placebo|
16341809|NCT00331045|Drug|Alvimopan 0.5 mg/day|
16341810|NCT00331045|Drug|Alvimopan 1 mg/day|
16355067|NCT00223197|Drug|Pregnenolone|
16341811|NCT00331032|Drug|3% w/w SPL7013 Gel|Twice-daily vaginal application of 3.5 g of VivaGel™ (Carbopol®-based gel with 3% w/w SPL7013) in single use pre-filled applicators.
16341812|NCT00331032|Drug|Placebo|Placebo gel (Carbopol®-based formulation alone) in single use pre-filled applicators.
16341813|NCT00331006|Drug|Rituximab|Rituximab by slow intravenous infusion; for participants greater than or equal to 10 kg, 375 mg per m^2 BSA weekly for 4 weeks; for participants less than 10 kg, 12.5 mg/kg weekly for 4 weeks
16341814|NCT00330993|Drug|mifepristone, misoprostol|
16341815|NCT00330980|Drug|40 mg Pravastatin (Pravachol)|Participants will receive 40 mg of pravastatin for 6 months.
16341816|NCT00330980|Drug|20 mg Simvastatin|Participants will receive 20 mg of simvastatin for 6 months.
16341817|NCT00330980|Drug|Placebo|Participants will receive placebo for 6 months.
16341818|NCT00330967|Drug|20% Intralipid|lipid infusion
16341819|NCT00330941|Drug|lidocaine|
16341820|NCT00330928|Device|Near Infrared Spectroscopy (NIRS) Imaging|Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
16341821|NCT00330928|Device|intravascular ultrasound (IVUS)|Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.
16341822|NCT00330915|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
16341823|NCT00330902|Drug|sulfadoxine-pyrimethamine (SP) plus artesunate (AS)|sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
16341824|NCT00330902|Drug|primaquine (PQ) plus SP+AS|single dose of primaquine on day 4
16341825|NCT00330876|Drug|Pitavastatin|
16341826|NCT00330863|Drug|Risperidone microspheres|Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
16341827|NCT00330863|Drug|Risperidone|Target dose is 4 mg/day.
16341828|NCT00330863|Drug|Olanzapine|Target dose is 15 mg/day.
16341829|NCT00330863|Drug|Quetiapine|Target dose is 600 mg/day.
16341830|NCT00330863|Drug|Ziprasidone|Target dose is 120 mg/day.
16341831|NCT00330863|Drug|Aripiprazole|Target dose is 20 mg/day.
16341832|NCT00330863|Drug|Paliperidone|Target dose is 6 mg/day.
16341833|NCT00330850|Drug|PRO-513|
16341834|NCT00330824|Drug|antibiotic/steroid combination|1gtt, 4x/d, 15 days
16341835|NCT00330824|Drug|moxifloxacin/dexamethasone|1gtt, 4x/days, 15 days
16341836|NCT00330798|Drug|nepafenac 0.1%|Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
16341837|NCT00330798|Other|ketorolac 0.4%|Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.
16341838|NCT00330785|Drug|Amlodipine/Atorvastatin|
16341839|NCT00330772|Drug|Aspirin|
16341840|NCT00330772|Drug|Clopidogrel|
16341841|NCT00330759|Biological|Denosumab|120 milligrams by subcutaneous injection every 4 weeks
16341842|NCT00330759|Drug|Zoledronic Acid|4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
16341843|NCT00330746|Drug|cetuximab|400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression
16341844|NCT00330746|Drug|gemcitabine|1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles
16341845|NCT00330746|Drug|gemcitabine|1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles
16341846|NCT00330746|Drug|cetuximab|400 mg/m2 first dose followed by 250 mg/m2 weekly
16341847|NCT00330733|Drug|Salsalate|Participants were randomized to 12-week treatment with up to 4 g/day.
16341848|NCT00330733|Drug|Placebo|Participants were randomized to 12-week treatment matching the active salsalate arm.
16341849|NCT00330720|Device|Emergency Response System (Device)|
16341850|NCT00330707|Drug|Bacillus Calmette Guerin and interferon alpha|
16341851|NCT00330694|Other|ParkNet|Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.
16341852|NCT00330694|Other|Usual Care|No altered organisation of physiotherapy care in Parkinson's Disease
16341853|NCT00330681|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16341854|NCT00330681|Drug|Placebo of MCI-186|Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16341855|NCT00330668|Drug|rh IGF-1 (mecasermin)|Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.
16341856|NCT00330655|Drug|memantine|
16341857|NCT00330629|Behavioral|Standard Behavioral Treatment|Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.
16341858|NCT00330629|Behavioral|SBT+LOV|The focus will be on the elimination of meat products as a means to reduce fat intake.
16341859|NCT00330616|Drug|323U66 SR|
16341860|NCT00330603|Procedure|Serial exhaled breath collections|collect breath for 5 minutes on 8 occasions
16341861|NCT00330577|Drug|timolol maleate 0.5%|
16341862|NCT00330577|Drug|latanoprost/timolol fixed combination|
16341863|NCT00330577|Drug|placebo (artificial tears)|
16341864|NCT00330564|Drug|SU011248|50 mg/day orally for 4 weeks, no treatment for 2 weeks (6 weeks = 1 cycle).
16341865|NCT00330551|Drug|Oral Risperidone|Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.
16341933|NCT00329992|Behavioral|Brief Eclectic Psychotherapy for PTSD|16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
16341866|NCT00330551|Drug|Risperidone in Long-Acting Injectable Form (Consta)|Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
16341867|NCT00330525|Drug|sibutramine|
16341868|NCT00330499|Drug|Cisplatin|Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
16341869|NCT00330499|Radiation|External beam radiation treatment|64Gy reference dose in 32 fractions over 6.5 weeks
16341870|NCT00330486|Drug|Acamprosate|
16341871|NCT00330473|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
16341872|NCT00330473|Drug|Insulin|patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)
16341873|NCT00330460|Drug|Alendronate|ALN; 70 mg; oral; once weekly
16341874|NCT00330460|Drug|Denosumab|60 mg; SC; every 6 months
16341875|NCT00330434|Other|Trial Withdrawn 1|Trial Withdrawn 1
16341876|NCT00330434|Other|Trial Withdrawn 2|Trial Withdrawn 2
16341877|NCT00330421|Drug|sorafenib tosylate|Given PO
16341878|NCT00330421|Procedure|therapeutic conventional surgery|Undergo surgery
16341879|NCT00330421|Other|laboratory biomarker analysis|Correlative studies
16341880|NCT00330421|Other|pharmacological study|Correlative studies
16341881|NCT00330421|Procedure|computed tomography|Correlative studies
16341882|NCT00330421|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative studies
16341883|NCT00330408|Behavioral|GP training|
16341884|NCT00330395|Drug|caspofungin acetate|Duration of Treatment 28 Days
16341885|NCT00330382|Drug|Bowman-Birk inhibitor concentrate|Given orally
16341886|NCT00330382|Other|placebo|Given orally
16341887|NCT00330382|Other|laboratory biomarker analysis|Correlative studies
16341888|NCT00330369|Drug|Darusentan|Darusentan administered orally once daily
16341889|NCT00330369|Drug|Darusentan Placebo|Placebo to match darusentan administered orally once daily
16341890|NCT00330356|Behavioral|Low Salt Diet versus High salt diet|
16341891|NCT00330343|Drug|naloxone|continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
16341892|NCT00330330|Drug|ISIS 113715|
16341893|NCT00330317|Drug|letrozole|2.5mg letrozole once-daily
16341894|NCT00330304|Drug|Isoniazid|isoniazid 10mg/kg orally, daily, for study period
16341895|NCT00330304|Drug|Cotrimoxazole|Cotrimoxazole given 3 times a week or daily, orally, for study period
16341896|NCT00330304|Drug|isoniazid|Isoniazid, 10mg/kg daily for study period
16341897|NCT00330304|Other|placebo|Placebo tablet identicle in appearance to intervention: isoniazid table
16341898|NCT00330291|Drug|Xyrem|
16341899|NCT00330278|Drug|Cefazolin|
16341900|NCT00330265|Device|KC-002|Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
16341901|NCT00330265|Other|Conventional Wound Therapy|Normal Saline Dressings
16341902|NCT00330252|Drug|Rituximab|Given intravenously on day 1 of every week for eight weeks (or 16 weeks)
16341903|NCT00330252|Drug|Alemtuzumab|Drug: Alemtuzumab Dosage will vary during Phase I of trial: Given intravenously on days 1, 3, and 5 for weeks one and two, on days 1 and 4 for weeks three and four and on day 1 for weeks five through eight. Participants may receive either one eight-week course of treatment or two eight-week courses of treatment (16 weeks).
16341904|NCT00330239|Drug|Paroxetine CR|
16341905|NCT00330213|Behavioral|red wine and cognac consumption|
16341906|NCT00330200|Drug|ISIS 113715|
16341907|NCT00330187|Drug|Bupropion SR|Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
16341908|NCT00330187|Behavioral|Contingency Management|Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
16341909|NCT00330187|Other|Placebo|Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
16341910|NCT00330174|Drug|Acamprosate|2 333mg tablets three times daily
16341911|NCT00330161|Drug|vorinostat|Given orally
16341912|NCT00330161|Other|laboratory biomarker analysis|Correlative studies
16341913|NCT00330148|Drug|melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d|
16341914|NCT00330148|Drug|melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d|
16341915|NCT00330148|Drug|nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d|
16341916|NCT00330135|Drug|Sodium hyaluronate|Sodium hyaluronate 2.5 ml - 1 injection
16341917|NCT00330135|Drug|placebo injection|placebo injection - 1 injection
16341918|NCT00330122|Procedure|fore locked plate|
16341919|NCT00330122|Procedure|external radiocarpal fixer|
16341920|NCT00330109|Procedure|MRS Imaging|Performed on a 3.0 Tesla Philips Intera MRI Unit (Best, Netherlands). Scout views and T2 transverse images are obtained to locate the tumor in conjunction with any previous diagnostic images.
16341921|NCT00330109|Procedure|PET Scanning|Using an Allegro scanner, the patient will be scanned for approximately 20-30 minutes. All emission scan data is processed by a multi-step procedure.
16341922|NCT00330109|Procedure|Diffusion Tensor Imaging|Subjects will be scanned with a 3T Philips Intera MRI scanner for approximately 26 minutes for anatomical and DTI imaging. Total DTI acquisition time will be 6:06 minutes with 40 contiguous axial slices for full brain coverage.
16341923|NCT00330096|Drug|Hesperidin|
16341924|NCT00330096|Other|Placebo|
16341925|NCT00330083|Biological|ALK Ragweed Tablet|
16341926|NCT00330070|Drug|IPL512,602 20 mg once daily|
16341927|NCT00330070|Drug|IPL512,602 Matching Placebo once daily|
16341928|NCT00330044|Drug|Premetrexed (Alimta)|
16341929|NCT00330044|Drug|Carboplatin|
16341930|NCT00330018|Drug|Valganciclovir|Valganciclovir
16341931|NCT00330018|Drug|Acyclovir|Acyclovir
16341932|NCT00330005|Behavioral|Group Psychotherapy|
16341934|NCT00329979|Behavioral|vascular access site|Randomized vascular access site
16341935|NCT00329966|Biological|Surface Antigen, Inactivated, Influenza (form.2006-07)|
16341936|NCT00329940|Drug|Letrozole|
16341937|NCT00329927|Biological|Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07|
16341938|NCT00329914|Drug|Progesterone|Vaginal pessaries, 200 mg/day
16341939|NCT00329914|Drug|Placebo|Placebo pessaries containing peanut oil
16341940|NCT00329901|Biological|Meningococcal ACWY conjugate vaccine (MenACWY-CRM)|
16341941|NCT00329901|Biological|Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)|
16341942|NCT00329901|Biological|saline placebo|4.5 mg sodium chloride per 0.5 ml dose
16341943|NCT00329888|Procedure|Endoscopic papillary balloon dilatation|
16341944|NCT00329888|Procedure|Endoscopic sphincterotomy|
16341945|NCT00329862|Procedure|Laparoscopic Truncal Vagotomy|
16341946|NCT00329849|Biological|Meningococcal ACWY-CRM conjugate vaccine|MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
16341947|NCT00329849|Biological|Meningococcal ACWY-PS polysaccharide vaccine|MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.
16341948|NCT00329836|Other|There are no interventions in the observational study. The symptom of allodynia was measured.|No intervention. Description of allodynia testing appears elsewhere in this document
16341949|NCT00329823|Drug|Etanercept sc 50mg per week for 12 weeks|
16341950|NCT00329810|Drug|Aripiprazole|Tablets, oral, 15 mg, once daily, 12 weeks.
16341951|NCT00329797|Dietary Supplement|Calcium|A single dose of 500 mg of elemental calcium orally each day for 3 years.
16341952|NCT00329797|Dietary Supplement|Zoledronic acid|Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
16341953|NCT00329797|Radiation|radiation therapy|Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
16341954|NCT00329797|Drug|LHRH|LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
16341955|NCT00329797|Dietary Supplement|Vitamin D|400 IU (10μg), orally each day for 3 years.
16341956|NCT00329784|Biological|Peanut Consumption Group|Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
16341957|NCT00329771|Other|No intervention: We are testing for the presence of allodynia|We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
16341958|NCT00329758|Drug|rosuvastatin|20 mg oral, during 10 days
16341959|NCT00329758|Drug|Placebo|
16341960|NCT00329745|Biological|Rotarix™|Oral administration, 2 doses
16341961|NCT00329745|Biological|Placebo|Oral administration, 2 doses
16341962|NCT00329732|Drug|0.5% bupivicaine and 2% lidocaine|The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache
16341963|NCT00329732|Drug|Saline placebo|matching volume of saline (placebo)
16341964|NCT00329719|Procedure|Conventional Surgery|Undergo surgery
16341965|NCT00329719|Other|Laboratory Biomarker Analysis|Correlative studies
16341966|NCT00329719|Drug|Sorafenib Tosylate|Given PO
16341967|NCT00329719|Drug|Temsirolimus|Given IV
16341968|NCT00329706|Procedure|FDG-PET brain scan|The difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years.
16341969|NCT00329693|Drug|Norprolac|Placebo
16341970|NCT00329693|Drug|Norprolac|Quinagolide
16341971|NCT00329693|Drug|Norprolac|Quinagolide
16341972|NCT00329693|Drug|Norprolac|Quinagolide
16341973|NCT00329680|Dietary Supplement|Eicosapentaenoic acid, Gamma-Linolenic Acid and Antioxidant Vitamins|An enteral diet will be given in accordance with the caloric goal calculated by the Harris-Benedict equation x 1.3. The enteral diet will be provided for a period of 7 days or until death OR start of oral diet OR start of parenteral diet OR discharge from the ICU OR decision from the attending physician/family/patient to no longer participate in this clinical study
16341974|NCT00329680|Dietary Supplement|Standard ICU enteral diet, isocaloric to the study diet|Patients will receive this diet in a blinded way using the same dose regimen specified previously and used in the study group
16341975|NCT00329667|Device|EPIC|Surgical replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic and/or mitral heart valves
16341976|NCT00329654|Procedure|Phototherapy with the Embar® light therapy or sham irradiation|Phototherapy with the Embar® light therapy or sham irradiation is followed.
16341977|NCT00329641|Drug|carboplatin|Given IV
16341978|NCT00329641|Drug|paclitaxel|Given IV
16341979|NCT00329641|Drug|sorafenib tosylate|Given orally
16341980|NCT00329628|Drug|Rivaroxaban (BAY59-7939)|10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
16341981|NCT00329628|Drug|Enoxaparin|Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days
16341982|NCT00329615|Drug|Insulatard, flexpen|
16341983|NCT00329602|Drug|Placebo|Matching Placebo
16341984|NCT00329602|Drug|Ropinirole|Ropinirole IR 0.25mg/day to 4mg/day for RLS
16341985|NCT00329589|Drug|Velcade (bortezomib)|
16341986|NCT00329576|Biological|Hepatitis B vaccine|
16342077|NCT00328861|Drug|Natural Killer (NK) Lymphocytes|Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
16355454|NCT00219219|Drug|Zoledronic acid|
16341987|NCT00329563|Drug|Up to 2 liter infusion of cold 4 degree C normal saline|Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.
16341988|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
16341989|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
16341990|NCT00329550|Biological|Certolizumab pegol (CZP)|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 400 mg at Weeks 0, 2 and 4.
16341991|NCT00329537|Drug|Sargramostim (Leukine)|Self-subcutaneous injection
16341992|NCT00329537|Drug|Placebo|Self-subcutaneous injection
16341993|NCT00329524|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.
16341994|NCT00329511|Drug|methyldopa vs. clonidine|Comparison of compliance
16341995|NCT00329511|Drug|clonidine patch|methyldopa 250 - 750 mg qid clonidine patch 0.1 - 0.4 mg q week
16341996|NCT00329498|Drug|L-Ascorbic Acid|
16341997|NCT00329485|Drug|CORvalen (D-Ribose)|
16341998|NCT00329472|Drug|gemcitabine, cisplatin|
16341999|NCT00329459|Drug|sumatriptan succinate/naproxen sodium|
16342000|NCT00329459|Drug|placebo|placebo to match
16342001|NCT00329446|Drug|Quetiapine Fumarate|
16342002|NCT00329446|Drug|Escitalopram oxylate|
16342003|NCT00329433|Drug|Desirudin (Iprivask™)|Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.
16342004|NCT00329433|Drug|Heparin|The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).
16342005|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.
16342006|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.
16342007|NCT00329420|Biological|Certolizumab pegol|Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
16342008|NCT00329407|Drug|Topiramate (Topamax)|Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM & 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM & 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM & 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM
16342009|NCT00329394|Drug|ketamine|Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
16342010|NCT00329381|Drug|Xolair|Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
16342011|NCT00329381|Drug|Xolair|Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
16342012|NCT00329368|Biological|EC90 (KLH-FITC)|1.2mg in combination with adjuvant GPI-0100 administered subcutaneously, weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
16342013|NCT00329368|Biological|GPI-0100|3.0mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
16342014|NCT00329368|Drug|EC17 (Folate-FITC)|0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks followed by 2 observation weeks for each cycle.
16342015|NCT00329368|Drug|Interleukin-2|Low dose (7-12 MIU) IL-2 administered subcutaneously three times per week (MWF) for 3 consecutive weeks during the first cycle, 4 consecutive weeks during cycle 2 and additional cycles
16342016|NCT00329368|Drug|Interferon-alpha|3.0 MIU administered subcutaneously 3 times per week (MWF) for 3 consecutive weeks during the first cycle of treatment, then 3.0 MIU administered subcutaneously 3 times per week (MWF) for 4 weeks for cycle 2 and additional cycles.
16342017|NCT00329355|Drug|sumatriptan succinate/naproxen sodium|
16342018|NCT00329342|Behavioral|Occupational ergonomic training|Adequate postural habits in activities of daily living
16342019|NCT00329329|Drug|satraplatin and capecitabine|satraplatin and capecitabine dose escalated per the dosing scheme
16342020|NCT00329316|Drug|Crinone Gel 8%|
16342078|NCT00328861|Biological|IL-2|IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days.
16342079|NCT00328861|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7.
16342080|NCT00328861|Drug|Fludarabine|Fludarabine 25 mg/m^2 day intravenous on days -6 through -2.
16355455|NCT00219193|Drug|aliskiren|
16342021|NCT00329303|Drug|Certolizumab Pegol (Cimzia®)|"Pharmaceutical Form: Solution for injection in pre-filled syringe
~Route of Administration: Subcutaneous use
~Dose and Administration details :
~2 x 1 mL Certolizumab Pegol at Week 0, followed by
~1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
~2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10"
16342022|NCT00329277|Procedure|perimetry|
16342023|NCT00329264|Drug|Quetiapine fumarate|
16342024|NCT00329251|Biological|Hepatitis A|
16342025|NCT00329251|Biological|Hepatitis B|
16342026|NCT00329251|Biological|Influenza|
16342027|NCT00329251|Biological|Pneumococcal|
16342028|NCT00329251|Biological|Tetanus-diphteria|
16342029|NCT00329251|Biological|Varicella|
16342030|NCT00329251|Biological|Measles-Mumps-Rubella|
16342031|NCT00329238|Drug|Dabigatran|Dabigatran 150 mg BID (twice daily)
16342032|NCT00329238|Drug|Warfarin|Warfarin dosed individually to maintain INR 2.0-3.0
16342033|NCT00329225|Drug|rosiglitazone|
16342034|NCT00329212|Drug|San Huang Xie Jin Tang|
16342035|NCT00329199|Behavioral|Attachment-Based Family Therapy|
16342036|NCT00329186|Drug|desvenlafaxine SR|
16342037|NCT00329186|Drug|venlafaxine ER|
16342038|NCT00329173|Drug|Rosuvastatin|
16342039|NCT00329173|Drug|Atorvastatin|
16342040|NCT00329160|Drug|Rosuvastatin|2.5-20 mg
16342041|NCT00329160|Drug|HMG CoA inhibitor|3-hydroxy-3-methylglutaryl-coenzyme A
16342042|NCT00329147|Drug|desvenlafaxine SR|
16342043|NCT00329147|Drug|desipramine|
16342044|NCT00329147|Drug|paroxetine|
16342045|NCT00329134|Drug|Administration of quinine sulphate taste-masked pellets|
16342046|NCT00329121|Drug|PEP005|
16342047|NCT00329108|Drug|ziprasidone hydrochloride|Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.
16342048|NCT00329108|Drug|olanzapine|Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
16342049|NCT00329095|Drug|travoprost, latanoprost, or bimatoprost|
16342050|NCT00329095|Drug|Additional ocular hypotensive medication|
16342051|NCT00329082|Drug|LY2062430|"100mg QW IV for 12 weeks
~100mg Q4W IV for 12 weeks
~400mg QW IV for 12 weeks
~400mg Q4W IV for 12 weeks"
16342052|NCT00329082|Drug|Placebo|5: Placebo QW IV for 12 weeks
16342053|NCT00329069|Drug|atorvastatin (drug)|
16342054|NCT00329056|Drug|MitoQ|Two doses will be compared to placebo: 40 or 80 mg of MitoQ once daily for a period of 12 months.
16342055|NCT00329043|Drug|LHRH Agonist|Intramuscular injection either monthly for 3 months or in a single 3-month dose.
16342056|NCT00329043|Drug|Sunitinib Malate|25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
16342057|NCT00329043|Procedure|Radical Prostatectomy|Radical prostatectomy after completion of Sunitinib and LHRH agonist.
16342058|NCT00329030|Drug|Autologous transplantation using rituxan/BEAM|Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
16342059|NCT00329030|Drug|Autologous transplantation using Bexxar/BEAM|Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
16342060|NCT00329017|Procedure|Fine needle aspiration|Fine needle aspiration
16342061|NCT00329004|Drug|BMS-690514|Tablets, Oral, up to 300 mg, once daily, up to 24 mos
16342062|NCT00328991|Device|duct tape occlusion therapy|
16342063|NCT00328978|Drug|Quetiapine|
16342064|NCT00328965|Drug|Lacidipine|Lacidipine 2, 4, 6mg
16342065|NCT00328939|Drug|ARIXTRA infusion|
16342066|NCT00328939|Drug|Enoxaparine infusion|
16342067|NCT00328926|Drug|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and estradiol [E2] levels). Total duration will be of 3 treatment cycles.
16342068|NCT00328926|Drug|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
16342069|NCT00328926|Drug|Placebo|Placebo will be administered subcutaneously once daily. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
16342070|NCT00328926|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU will be administered subcutaneously for 7 days. After 7 days of treatment, if the subject response will suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
16342071|NCT00328926|Drug|Recombinant human chorionic gonadotropin (r-hCG)|When the follicular response will adequate, ovulation will be triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle will be up to 14 days, or maximum of 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration will be of 3 treatment cycles.
16342072|NCT00328913|Drug|5-hydroxytryptophan (food supplement)|
16342073|NCT00328900|Drug|Administration of 0,7 mg of atropine|
16342074|NCT00328900|Device|Measurement of skin conductance with Pain detector|
16342075|NCT00328887|Genetic|CD40 Gene Transfer|gene transfer, intratumoral administration
16342076|NCT00328874|Drug|Coenzyme Q10|
16342081|NCT00328848|Behavioral|Behavioral|Group Treatment(patient education, self management support, caregiver support)
16342082|NCT00328848|Behavioral|behavioral|patient education, self management support, caregiver support
16342083|NCT00328835|Procedure|Brief Elevation of IOP|
16342084|NCT00328822|Drug|Quetiapine|
16342085|NCT00328822|Drug|placebo|
16342086|NCT00328809|Drug|spironolactone|spironolactone administered to ESRD patients at low dose
16342087|NCT00328796|Procedure|acupuncture in 6 specific points|
16342088|NCT00328796|Drug|lidocaine 10mg/ml|
16342089|NCT00328783|Device|Active Breathing Coordinator (ABC)|The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
16342090|NCT00328783|Radiation|Radiation Therapy|
16342091|NCT00328770|Drug|Sirolimus|Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
16342092|NCT00328757|Behavioral|Regular diet as the first postoperative meal|
16342093|NCT00328744|Behavioral|Standard|18-month standard behavioral weight loss intervention
16342094|NCT00328744|Behavioral|Limited Variety|Two chosen snack foods
16342095|NCT00328731|Procedure|Procedure|
16342096|NCT00328718|Drug|montelukast (5mg QD)|
16342097|NCT00328718|Drug|Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)|
16342098|NCT00328705|Device|Implantable Cardioverter Defibrillator|
16342099|NCT00328692|Drug|rolofylline|rolofylline 30 mg IV QD; 3 days
16342100|NCT00328692|Drug|Comparator: Placebo (unspecified)|rolofyline Pbo 30 mg IV QD; 3 days
16342101|NCT00328679|Device|in vitro and in vivo allergy testing|Patch Test: food to be tested is suspended in sterile saline, placed on the skin of the back using a Finn Chamber secured with surgical tape and left in place for 48 hours.
16342102|NCT00328666|Behavioral|Iyengar yoga|
16342103|NCT00328666|Behavioral|Enhanced nutritional care classes|
16342104|NCT00328653|Drug|cyclosporine|
16342105|NCT00328640|Drug|Optimal treatment|
16342106|NCT00328627|Drug|Alogliptin|Alogliptin tablets.
16342107|NCT00328627|Drug|Alogliptin placebo|Alogliptin placebo-matching tablets.
16342108|NCT00328627|Drug|Pioglitazone|Pioglitazone tablets.
16342109|NCT00328627|Drug|Pioglitazone placebo|Pioglitazone placebo-matching tablets.
16342110|NCT00328614|Drug|Samarium-153|Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).
16342111|NCT00328614|Drug|Total Androgen Suppression (TAS) with Bicalutamide|Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
16342112|NCT00328614|Drug|Total androgen suppression (TAS) with Goserelin Acetate|Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
16342113|NCT00328614|Device|Radiation Therapy|Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.
16342114|NCT00328601|Drug|Thioctic Acid|
16342115|NCT00328588|Drug|YM155|IV
16342116|NCT00328575|Radiation|Intensity-Modulated Radiotherapy (IMRT)|"The duration of radiation therapy will be total of 3 weeks. During the first week, all patients will be treated initially with whole brain radiation therapy (WBRT) at 2.5Gy per fraction daily 5 days a week to a dose of 12.5Gy. This will be delivered through parallel-opposed fields to cover the entire cranial contents.
~For the remaining 2 weeks, patients will be treated using intensity-modulated radiation therapy (IMRT) technology such that a higher dose can be delivered to the tumor. IMRT is capable of generating complex 3-D dose distribution to conform closely to the target volume by modulating the radiation beam. This process is based on the inverse method of treatment planning to optimize radiation dose to tumor target coverage and normal tissue sparing."
16342117|NCT00328562|Drug|ZD1839 (Iressa)|
16342118|NCT00328562|Radiation|Thoracic Radiotherapy|
16342119|NCT00328549|Drug|Pegylated Interferon and Ribavirin|
16342120|NCT00328536|Drug|Omacor|
16342121|NCT00328523|Drug|MK-0653, ezetimibe|
16342122|NCT00328523|Drug|Duration of Treatment: 3 months|
16342123|NCT00328510|Device|GTC frame|
16342124|NCT00328510|Device|Thermoplastic facemask|
16342125|NCT00328510|Radiation|Stereotactic radiation therapy|
16342126|NCT00328497|Drug|Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)|Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
16342127|NCT00328484|Behavioral|Lifestyle Activity Program|The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support.
16342128|NCT00328484|Behavioral|Exercise Program|The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
16342129|NCT00328471|Behavioral|care management|
16342130|NCT00328458|Drug|EPO906 (epothilone B)|
16342131|NCT00328445|Behavioral|Positive Action|See publications
16342132|NCT00328432|Drug|celecoxib 400 mg bid|
16342133|NCT00328419|Device|photoprotected bags, tubing, syringes|use of photoprotected parenteral nutrition device
16342134|NCT00328419|Device|standard tubing and bags|Use of standard (transparent) parenteral nutrition device
16342135|NCT00328393|Drug|Pioglitazone|45 mg 8 weeks
16342136|NCT00328393|Drug|Placebo|Placebo
16342137|NCT00328380|Drug|Rifaximin|
16342138|NCT00328367|Drug|aripiprazole|aripiprazole augmentation of clozapine
16342139|NCT00328367|Drug|placebo|placebo
16342140|NCT00328302|Drug|Candesartan|
16342141|NCT00328302|Drug|Placebo|
16342142|NCT00328289|Device|transcutaneous muscle stimulation, treadmill|
16342143|NCT00328276|Drug|Sarcosine|
16342144|NCT00328263|Dietary Supplement|Lactobacillus acidophilus CL1285 and Lactobacillus casei|One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
16342145|NCT00328263|Dietary Supplement|placebo|One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
16342146|NCT00328250|Behavioral|Cognitive behavioral treatment (CBT) delivered over the Internet|CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies.
16342147|NCT00328237|Procedure|Cord Blood Transplant|
16342148|NCT00328211|Dietary Supplement|Bile Acids (Cholic, Ursodeoxycholic, Chenodeoxycholic)|15 mg/kg/day for 18 days
16342149|NCT00328211|Dietary Supplement|Sphingomyelin|1000mg/day for 19 days
16342150|NCT00328211|Other|C13 Stable isotope of Cholesterol|Food provided for 3 days and one time dose of 113mg of C13 Cholesterol.
16342151|NCT00328198|Biological|Alemtuzumab|"Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks.
~Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study."
16342152|NCT00328198|Biological|Alemtuzumab|"Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks.
~Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration."
16342153|NCT00328172|Drug|Placebo|Placebo matching BI 1356
16342154|NCT00328172|Drug|BI 1356 dose 3 once daily|BI 1356 dose 3 once daily
16342155|NCT00328172|Drug|BI 1356 dose 2 once daily|BI 1356 dose 2 once daily
16342156|NCT00328172|Drug|BI 1356 dose 1 once daily|BI 1356 dose 1 once daily
16342157|NCT00328172|Drug|Metformin|Metformin
16342158|NCT00328159|Drug|Oil special 107 and MYGLIOL 810|
16342159|NCT00328146|Other|Observation of sternal reentry|Observation of sternal reentry
16342160|NCT00328120|Drug|Fulvestrant|500 mg intramuscular injection
16342161|NCT00328107|Biological|Influenza Vaccine, recombinant Hemagglutinin|0.5mL dose for IM injection
16342162|NCT00328094|Drug|continuous intravenous insulin infusion|Tight glucose control versus standard of care
16342163|NCT00328055|Behavioral|AD-Easy (Advance Directive-Easy)|
16342164|NCT00328055|Behavioral|AD-Standard (Advance Directive-Standard)|
16342165|NCT00328042|Behavioral|Self-Management Workshop|The workshop is a once per week 2.5 hour group that meets for six weeks.
16342166|NCT00328042|Behavioral|Information Only|This is an individual self-paced at home study program.
16342167|NCT00328029|Drug|busulfan|5mg/kg/day (oral route : 4 doses/day for 4 days)
16342168|NCT00328029|Procedure|respiratory function tests|respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
16342169|NCT00328029|Procedure|pharmacokinetics, done during the treatment|"12 blood collections :
~after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h.
~3 hours after 2nd taken of Busulfan
~3 hours after 3rd taken of Busulfan
~3 hours after 4th taken of Busulfan
~3 hours after 5th taken of Busulfan
~3 hours after 6th taken of Busulfan."
16342170|NCT00328016|Behavioral|Guided Breathing|The participant will engage in daily 15 min sessions of meditative relaxation that involves quiet attention to breathing pattern with no attempt to manipulate breathing pattern
16342171|NCT00328016|Device|RESPeRATE|The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
16342172|NCT00327990|Drug|Ibandronate|
16342173|NCT00327990|Drug|Alendronate|
16342174|NCT00327938|Device|Measuring of skin conductance|
16342175|NCT00327938|Procedure|Tetanic stimuli|
16342176|NCT00327925|Procedure|Find Cancer Associated Antibodies|
16342177|NCT00327912|Procedure|Laparoscopic Biliopancreatic diversion with Duodenal switch|
16342178|NCT00327912|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
16342179|NCT00327873|Other|Oxygen|2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
16342180|NCT00327873|Other|Medical Air|2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
16342181|NCT00327847|Drug|Oral Vitamin D Supplementation|
16342182|NCT00327834|Drug|atomoxetine|
16342183|NCT00327821|Behavioral|calorie controlled diet|
16342184|NCT00327808|Drug|TPI-1020|600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
16342185|NCT00327808|Drug|budesonide|400 mcg BID x 14 days then 800 mcg/day x 7 more days
16342186|NCT00327769|Drug|Fulvestrant|250 mg intramuscular injection
16342187|NCT00327769|Drug|Anastrozole|1 mg tablet
16342188|NCT00327756|Drug|Coenzyme Q10|
16342189|NCT00327743|Drug|larotaxel|IV infusion on Day 1 of a 21-day cycle
16342190|NCT00327743|Drug|capecitabine|oral, twice daily, Day 1-Day 14 of a 21-day cycle
16342191|NCT00327730|Drug|Eperisone|
16342251|NCT00327184|Biological|Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
16342252|NCT00327184|Biological|Infanrix Penta|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
16342192|NCT00327717|Drug|Zonisamide|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
16342193|NCT00327717|Drug|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
16342194|NCT00327704|Drug|albumin|albumin 20% 100 ml/8 hours for 3 days
16342195|NCT00327704|Drug|saline|saline 100 ml/8hours for 3 days
16342196|NCT00327691|Drug|Atorvastatin|
16342197|NCT00327678|Drug|Rituximab|
16342198|NCT00327678|Drug|Imatinib Mesylate|
16342199|NCT00327665|Biological|11-valent pneumococcal vaccine GSK513026|Two-dose intramuscular injection. Each group receiving one of the 3 formulations
16342200|NCT00327665|Biological|Pneumo 23™|Single-dose intramuscular injection.
16342201|NCT00327665|Biological|Placebo|1 intramuscular injection.
16342202|NCT00327665|Biological|10-valent pneumococcal vaccine GSK513026|Two-dose intramuscular injection
16342203|NCT00327652|Drug|CRS-100|Live-attenuated Listeria monocytogenes
16342204|NCT00327626|Drug|ISIS 113715|
16342205|NCT00327600|Drug|imexon|
16342206|NCT00327600|Drug|DTIC|
16342207|NCT00327587|Drug|Valsartan + amlodipine|
16342208|NCT00327587|Drug|Valsartan + HCTZ|
16342209|NCT00327587|Drug|Amlodipine + HCTZ|
16342210|NCT00327587|Drug|Valsartan + amlodipine + HCTZ|
16342211|NCT00327574|Behavioral|Home heath education +/_ GP training|
16342212|NCT00327561|Procedure|Intensive periodontal therapy|
16342213|NCT00327561|Procedure|Community based periodontal therapy|
16342214|NCT00327548|Behavioral|guided imagery|
16342215|NCT00327535|Drug|Darbepoetin alfa|According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
16342216|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|6.3 micrograms/kg every 3 weeks
16342217|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|9 micrograms/kg every 3 weeks
16342218|NCT00327535|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|12 micrograms/kg every 3 weeks
16342219|NCT00327522|Biological|pneumococcal vaccine|
16342220|NCT00327496|Biological|DC vaccine|
16342221|NCT00327483|Behavioral|Internet based education software|
16342222|NCT00327470|Drug|Pegaptanib Sodium 0.3 mg|Pegaptanib Sodium dosed every 6 weeks in affected eye.
16342223|NCT00327457|Behavioral|Help with physician office and patient management|
16342224|NCT00327457|Behavioral|Tailored physician recommendation letter|
16342225|NCT00327444|Drug|aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
16342226|NCT00327444|Drug|Placebo|Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
16342227|NCT00327444|Drug|aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the OL period.
16342228|NCT00327431|Genetic|Cheek swab samples for DNA|
16342229|NCT00327418|Drug|Atorvastatin|
16342230|NCT00327392|Drug|AQUAVAN® (fospropofol disodium) Injection|
16342231|NCT00327379|Drug|Trasylol (Aprotinin, BAYA0128)|Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
16342232|NCT00327379|Drug|Placebo|Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
16342233|NCT00327366|Procedure|Light therapy|
16342234|NCT00327353|Drug|formoterol (TURBOHALER)|
16342235|NCT00327353|Drug|Salmeterol (DISKUS)|
16342236|NCT00327340|Drug|custirsen (OGX-011)/mitoxantrone|"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle.
~Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes.
~Patients could receive a maximum of 9 cycles of treatment."
16342237|NCT00327340|Drug|custirsen (OGX-011)/docetaxel|"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle.
~Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes.
~Patients could receive a maximum of 9 cycles of treatment."
16342238|NCT00327327|Drug|imexon|30-60 minutes IV, days 1,8,15 every 28 days
16342239|NCT00327327|Drug|gemcitabine|30 minutes IV, days 1,8,15 every 28 days
16342240|NCT00327314|Procedure|Transplantation|
16342241|NCT00327314|Procedure|Hematopoietic cell transplantation|
16342242|NCT00327288|Drug|imexon|IV variable dosages, days 1-5 every 21 days for duration of study
16342243|NCT00327288|Drug|docetaxel|IV once every 21 days for duration of study
16342244|NCT00327275|Behavioral|strength training|
16342245|NCT00327262|Drug|Imatinib|
16342246|NCT00327249|Drug|imexon|
16342247|NCT00327223|Drug|imexon|
16342248|NCT00327210|Behavioral|Blood Glucose Awareness Training|
16342249|NCT00327197|Drug|Prednisolone|Subjects will be administered oral prednisolone at a dose of 0.5 mg/kg, up to a maximum of 40 mg per day for 14 days.
16342250|NCT00327197|Procedure|Bronchoscopy|All subjects will undergo bronchoscopy assessments which will involve insertion of a standard bronchoscope.
16355456|NCT00219180|Drug|aliskiren|
16342253|NCT00327184|Biological|Infanrix hexa|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
16342254|NCT00327184|Biological|Neis-Vac-C|Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
16342255|NCT00327171|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
16342256|NCT00327171|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
16342257|NCT00327158|Procedure|Transesophageal transducer|One time use of reamer during surgery
16342258|NCT00327158|Procedure|echocardiography|takes photos of right atrium during the reaming processes
16342259|NCT00327145|Drug|valsartan|
16342260|NCT00327145|Drug|hydrochlorothiazide|
16342261|NCT00327145|Drug|amlodipine|
16342262|NCT00327132|Drug|Omeprazole, Amoxicillin, Clarithromycin|
16342263|NCT00327119|Drug|ABX-EGF (panitumumab)|
16342264|NCT00327106|Drug|Tranexamic acid (Exacyl)|15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
16342265|NCT00327106|Drug|Placebo|NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
16342266|NCT00327093|Drug|cetuximab|indication : second intention treatment
16342267|NCT00327093|Drug|bevacizumab|Indication: first intention treatment
16342268|NCT00327080|Procedure|MRI|
16342269|NCT00327080|Drug|L-NMMA|
16342270|NCT00327080|Drug|Acetylcholine|
16342271|NCT00327054|Drug|Nigella sativa seed|
16342272|NCT00327028|Drug|Diphenine|
16342273|NCT00327015|Drug|Saxagliptin|Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
16342274|NCT00327015|Drug|Saxagliptin|Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
16342275|NCT00327015|Drug|Metformin|Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
16342276|NCT00327015|Drug|Placebo|Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
16342277|NCT00327015|Drug|pioglitazone|Tablets, Oral, 15-45 mg, as needed (12 months LT)
16342278|NCT00327002|Drug|LY518674|
16342279|NCT00326989|Procedure|intracoronary stem cell therapy|extracorporal shock waves prior to intracoronary cell therapy
16342280|NCT00326976|Drug|FX06|400 mg as intravenous injection in two divided boluses
16342281|NCT00326976|Procedure|Percutaneous coronary intervention|
16342282|NCT00326963|Drug|Background ARVs|As prescribed
16342283|NCT00326963|Drug|PI|As prescribed
16342284|NCT00326963|Drug|enfuvirtide [Fuzeon]|90mg sc bid
16342285|NCT00326950|Drug|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
16342286|NCT00326924|Biological|Transfusion|PRBC blood transfusions.
16342287|NCT00326911|Biological|cetuximab|I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1
16342288|NCT00326911|Biological|bevacizumab|10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
16342289|NCT00326911|Drug|gemcitabine|1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.
16342290|NCT00326911|Biological|cetuximab|I.V.infusions of 250 mg/m2 (over 60 minutes) weekly
16342291|NCT00326898|Other|Laboratory Biomarker Analysis|Correlative studies
16342292|NCT00326898|Other|Placebo|Given PO
16342293|NCT00326898|Other|Quality-of-Life Assessment|Ancillary studies
16342294|NCT00326898|Drug|Sorafenib Tosylate|Given PO
16342295|NCT00326898|Drug|Sunitinib Malate|Given PO
16342296|NCT00326885|Drug|catumaxomab|Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).
16342297|NCT00326872|Drug|Cediranib Maleate|
16342298|NCT00326859|Drug|remifentanil|
16342299|NCT00326833|Drug|vitamin B12|9 µg vitamin B12 three times daily for two days (CobaSorb)
16342300|NCT00326820|Drug|ibandronate sodium|
16342301|NCT00326820|Drug|zoledronic acid|
16342302|NCT00326820|Drug|Zolendronic Acid|Zoledronic acid 4 mg by intravenous infusion every 4 weeks.
16342303|NCT00326807|Drug|Naltrexone|
16342304|NCT00326794|Procedure|mobilisation (rehabilitation)|
16342305|NCT00326781|Drug|Nicoderm Transdermal Patch|The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.
16342306|NCT00326781|Drug|Nicotine Nasal Spray|8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.
16342307|NCT00326768|Drug|Telmisartan 40 mg/HCTZ 12.5 mg|
16342308|NCT00326768|Drug|Telmisartan 40 mg|
16342309|NCT00326768|Drug|Telmisartan 80 mg/HCTZ 12.5 mg|
16342310|NCT00326742|Behavioral|Trier Social Stress Test|
16342311|NCT00326716|Drug|Atazanavir + Ritonavir + Combivir|Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
16342312|NCT00326703|Procedure|Hypobaric hypoxia|
16342313|NCT00326690|Device|Blue Egg Device|
16342314|NCT00326677|Behavioral|Problem Solving Therapy|6 to 8 Problem Solving Therapy sessions over the course of 6 to 16 weeks followed by 3 booster PST sessions over the course of 2 years
16342487|NCT00325104|Procedure|Parathyroid hormone testing|
16355457|NCT00219167|Drug|aliskiren|
16342315|NCT00326677|Behavioral|Dietary Education|6 to 8 Diet Education sessions over the course of 6 to 16 weeks followed by 3 booster Diet Education sessions over the course of 2 years
16342316|NCT00326664|Drug|Cediranib Maleate|Given orally
16342317|NCT00326638|Radiation|Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy|"IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks
~Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23
~Boost IMRT to Prostate 3,200 cGy/16"
16342318|NCT00326638|Other|Arm A: 3D-Conformal Radiation|"3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks
~Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
~Boost 6 F 3DCRT to Prostate 3,200 cGy/16"
16342321|NCT00326612|Drug|Midazolam|Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
16342322|NCT00326612|Drug|Diazepam|Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
16342323|NCT00326599|Drug|carboplatin|Given IV
16342324|NCT00326599|Drug|cediranib maleate|Given orally
16342325|NCT00326599|Drug|gemcitabine hydrochloride|Given IV
16342326|NCT00326586|Drug|AR Antagonist (BMS-641988)|Tablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses
16342327|NCT00326573|Behavioral|Motivational Interviewing|
16342328|NCT00326560|Procedure|Pterygium excision and conjunctival autograft|
16342329|NCT00326508|Drug|Daclizumab|
16342330|NCT00326495|Drug|Cetuximab|Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
16342331|NCT00326495|Drug|BAY 43-9006|Is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro
16342332|NCT00326469|Drug|lanreotide (Autogel formulation)|120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
16342333|NCT00326456|Drug|liposomal doxorubicin|30 mg/m2 gieven intravenously on day 1 every 3 weeks
16342334|NCT00326456|Drug|carboplatin|AUC 5 intravenously on day 1 every 3 weeks
16342335|NCT00326456|Drug|paclitaxel|175 mg/m2 intravenously on day 1 every 3 weeks
16342336|NCT00326443|Biological|CVD 909|5 X 10^9 CFU of oral S. Typhi vaccine strain CVD 909 with buffer administered on Day 0.
16342337|NCT00326443|Drug|Placebo|Buffer placebo administered on Day 0.
16342338|NCT00326443|Biological|Vi Polysaccharide|25 micrograms (0.5 ml) of licensed purified Vi polysaccharide vaccine on Day 21.
16342339|NCT00326430|Behavioral|Cognitive Therapy, Interpersonal Therapy|
16342344|NCT00326404|Drug|Desogestrel-Ethinyl Estradiol 21 tablets|The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
16342345|NCT00326404|Drug|Desogestrel-Ethinyl Estradiol 28 tablets|The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
16342346|NCT00326391|Drug|methylphenidate hydrochloride extended-release tablets|
16342347|NCT00326378|Drug|consolidation chemotherapy with Docetaxel plus cisplatin|definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin
16342348|NCT00326378|Drug|CCRT arm without consolidation chemotherapy|definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy
16342349|NCT00326365|Drug|Kali bichromicum 10-60 (C30)|
16342350|NCT00326352|Drug|Sedation with propofol and remifentanil|
16342351|NCT00326339|Drug|R788|R788 50 mg, 100 mg, or 150 mg PO bid
16342352|NCT00326339|Drug|Placebo|Placebo PO bid
16342353|NCT00326326|Drug|CP-778,875|
16342354|NCT00326300|Drug|methylphenidate hydrochloride extended-release tablets|
16342355|NCT00326287|Drug|Ceftobiprole medocaril|
16342356|NCT00326287|Drug|Ceftriaxone with or without Linezolid|
16342357|NCT00326274|Drug|Helioblock® SX Cream|
16342358|NCT00326261|Procedure|Ultrasound compared to dual-endpoint nerve stimulator guided approach.|
16342359|NCT00326261|Procedure|Ultrasound|
16342360|NCT00326248|Drug|GW679769 (casopitant)|
16342361|NCT00326235|Drug|Buspirone|
16342362|NCT00326222|Behavioral|Lifestyle counseling|Self-management group education
16342363|NCT00326209|Drug|Encapsulated Mesalamine Granules (eMG)|eMG capsules will be administered per dose and schedule specified in the arm.
16342364|NCT00326196|Device|Percutaneous coronary intervention (PCI)|percutaneous coronary stenting with drug eluding stents
16342365|NCT00326196|Procedure|Coronary artery bypass graft (CABG)|coronary bypass
16342366|NCT00326183|Biological|VAQTA®|0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
16342367|NCT00326183|Biological|ProQuad|0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
16342368|NCT00326170|Drug|5-Azacytidine (5-aza)|Start at 75 mg/m^2 subcutaneously daily for 7 days.
16342369|NCT00326170|Drug|Valproic Acid|50 mg/kg daily by mouth for 7 days, same days as 5-aza.
16342370|NCT00326170|Drug|All-Trans Retinoic Acid (ATRA)|45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.
16342371|NCT00326157|Drug|AmBisome|3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration
16342372|NCT00326144|Drug|Quetiapine fumarate|
16342373|NCT00326131|Drug|Oral Taxane|
16342374|NCT00326118|Biological|Haemophilus influenzae type b and meningococcal serogroup C (vaccine)|One intramuscular dose at 12-18 months of age
16342375|NCT00326118|Biological|Priorix™|One subcutaneous dose at 12-18 months of age
16342376|NCT00326118|Biological|Hiberix™|One intramuscular dose at 12-18 months of age.
16342377|NCT00326118|Biological|Meningitec™|One intramuscular dose at 12-18 months of age
16342378|NCT00326105|Drug|Quetiapine fumarate|
16342379|NCT00326092|Drug|Brinzolamide/Timolol|
16342380|NCT00326079|Device|Stent|implantation of 1 Glaukos iStent versus 2 Glaukos iStents
16342381|NCT00326066|Device|Glaucoma Surgery|Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.
16342382|NCT00326066|Procedure|cataract surgery only|Subjects will undergo routine cataract surgery only (no stent implant).
16342383|NCT00326053|Drug|Budesonide/formoterol|
16342384|NCT00326040|Device|Glaucoma Surgery|
16342385|NCT00326027|Drug|Pantoprazole|Efficacy of Pantoprazole
16342386|NCT00326014|Device|iStent|Glaucoma Surgery
16342387|NCT00326001|Device|Gold tip catheter|Radiofrquency ablation using gold tip catheter
16342388|NCT00326001|Device|Platinum-iridium tip catheter|Radiofrequency ablation using platinum-iridium tip catheter
16342389|NCT00325962|Drug|6R-BH4 (sapropterin dihydrochloride)|
16342390|NCT00325949|Drug|Extended release hydrocodone and acetaminophen (Vicodin CR)|2 tablets BID
16342391|NCT00325949|Drug|hydrocodone/acetaminophen extended release (Vicodin CR)|1 tablet BID
16342392|NCT00325949|Drug|placebo|2 tablets BID
16342393|NCT00325936|Drug|Cilnidipine|10~20mg, qd, po for 3 months or 12 months.
16342394|NCT00325923|Behavioral|Decision aid|
16342395|NCT00325910|Drug|Metformin|
16342396|NCT00325897|Drug|Macrolide Antibiotic (Azithromycin)|Azithromycin (daily capsule, 250 mg for 12 months)
16342397|NCT00325897|Drug|Placebo|Placebo taken on a daily basis
16342398|NCT00325871|Procedure|concurrent chemoradiation|
16342399|NCT00325858|Drug|Tramadol HCl ER|
16342400|NCT00325845|Procedure|Synvisc viscosupplementation|
16342401|NCT00325832|Device|BpTRU|
16342402|NCT00325832|Device|Conventional mercury sphygmomanometry|
16342403|NCT00325819|Drug|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
16342404|NCT00325819|Other|placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
16342405|NCT00325806|Drug|Ramipril|
16342406|NCT00325793|Drug|Nicardipine|
16342407|NCT00325780|Drug|Pitavastatin|Pitavastatin 4 mg once daily
16342408|NCT00325767|Drug|nebulized albuterol (2.5 mg/3ml/dose)|
16342409|NCT00325767|Drug|nebulized levalbuterol (1.25 mg/3ml/dose)|
16342410|NCT00325767|Drug|nebulized placebo (3ml/dose)|
16342411|NCT00325754|Device|E-Cylinder|Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
16342412|NCT00325754|Device|Lightweight Cylinder|Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
16342413|NCT00325741|Procedure|Hematopoietic Cell Transplantation|1200 cGy total lymphoid irradiation (TLI) are administered on day -11 through -7 and days -4 through -1 pretransplantation; rabbit ATG at 1.5 mg/kg i.v. on days -11 through -7 pretransplantation; one single infusion of donor CD34+ cells plus selected T cell add back on completion of TLI (day 0); mycophenolate mofetil (MMF) is begun on day 0 at a dose of 15 mg/kg bid and stopped on day +28; cyclosporine (CSP) at initial dose of 6.25 mg/kg and adjusted to maintain trough blood levels of 350-500 ng/ml is begun on day -3 to complete withdrawal by 6 months post-transplantation.
16342414|NCT00325728|Drug|Ramelteon|Ramelteon 8mg, tablets, orally, once nightly for up to 8 weeks.
16342415|NCT00325728|Drug|Placebo|Ramelteon placebo matching tablets, orally, once nightly for up to 8 weeks.
16342416|NCT00325715|Drug|AGN 201904|
16342417|NCT00325715|Drug|esomeprazole|
16342418|NCT00325702|Behavioral|community-level intervention for young MSM|The community-level intervention includes small media in the form of role model stories, peer outreach and web-based intervention
16342419|NCT00325689|Drug|Quetiapine or Risperidone + Aripiprazole|Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
16342420|NCT00325689|Drug|Quetiapine or Risperidone + placebo|Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
16342421|NCT00325676|Drug|Pantoprazole|
16342422|NCT00325663|Procedure|Acupuncture|
16342423|NCT00325650|Drug|Rimonabant|Tablet, oral administration
16342424|NCT00325650|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16342425|NCT00325637|Drug|cilnidipine|Cilnidipine 10~20mg, qd, po for 4 weeks.
16342426|NCT00325624|Device|Bluetooth-enabled Glucometer|blood glucose information provided to health care providers
16342427|NCT00325611|Behavioral|Multidisciplinary palliative care team met with patient|
16342428|NCT00325598|Radiation|Partial Breast Irradiation (PBI)|
16342429|NCT00325585|Behavioral|Couples HIV counseling and testing|
16342430|NCT00325585|Behavioral|Women's relationship-focused HIV counseling and testing|
16342431|NCT00325572|Drug|oral zinc and vitamin C supplements|Each child will be provided separate suspensions containing zinc and vitamin C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation
16342488|NCT00325104|Procedure|Serum calcium testing|
16342489|NCT00325078|Drug|Infliximab|
16342664|NCT00323869|Drug|Gemcitabine|Nucleoside analog
16342432|NCT00325572|Other|oral Placebo|Each child will be provided separate Placebo suspensions C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation
16342433|NCT00325559|Procedure|Normoinsulinemic eu- or hyperglycemic clamp|
16342434|NCT00325546|Drug|Rimonabant (SR141716)|
16342435|NCT00325546|Drug|Placebo|
16342436|NCT00325533|Behavioral|Baseline BP Screening|Barbers in the barbershops in the experimental arm will be trained to accurately measure and interpret blood pressure (BP). Each barber will offer a BP check to customers with each haircut, complete an encounter form after each haircut, discuss the BP reading with the customer, identify customers with elevated BP, and refer customers with elevated BP to a regular physician or other primary provider for long-term BP management. Each time a customer with elevated BP goes to a regular medical provider, he receives a free haircut, and the referring barber receives a monetary bonus.
16342437|NCT00325533|Other|Intensive 10-week Blood Pressure Screening|Intensive 10-week Blood Pressure Screening
16342438|NCT00325507|Biological|TroVax|TroVax 1 x 10E9 TCID 50mL
16342439|NCT00325507|Drug|IL-2|IL-2 250,000 U/kg S/C for cycle 1 and day 1 of subsequent cycles, 125,000U/kg S/C for days 2-5 of cycles 2-6
16342440|NCT00325494|Drug|MORAb-009|Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m^2 up to 400 mg/m^2.
16342441|NCT00325481|Drug|FluMist|
16342442|NCT00325468|Drug|AMG 162|AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
16342443|NCT00325455|Drug|MK0859|
16342444|NCT00325442|Drug|Oral treprostinil (UT-15C) sustained release tablets|UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
16342445|NCT00325442|Drug|Placebo|Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
16342446|NCT00325429|Drug|Vildagliptin|
16342447|NCT00325416|Drug|melphalan|(Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)
16342448|NCT00325416|Drug|topotecan (TPT)|"Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2
~Phase II: Treatment at maximum tolerated dose (MTD)"
16342449|NCT00325416|Procedure|Autologous Stem Cell Rescue|Day 0
16342450|NCT00325403|Drug|Oral treprostinil (UT-15C) Sustained Release Tablets|Sustained release oral tablet, twice daily
16342451|NCT00325403|Other|Placebo|Placebo oral tablet twice daily
16342452|NCT00325390|Drug|clopidogrel (SR25990C)|
16342453|NCT00325377|Procedure|MME Procedure|
16342454|NCT00325364|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 months
16342455|NCT00325364|Drug|Injectable insulin|patient specific dose, injectable, before meals, 24 months
16342456|NCT00325351|Drug|Sagopilone (ZK 219477) + carboplatin|Chemotherapy for recurrent ovarian cancer
16342457|NCT00325338|Biological|Ragweed MATAMPL|
16342458|NCT00325325|Drug|everolimus and tacrolimus|
16342459|NCT00325312|Drug|carbon dioxide, subcutaneous application|
16342460|NCT00325299|Drug|Magnesium|
16342461|NCT00325286|Drug|Lithium Plus Extended- Release Carbamazepine|Preliminary phase subjects receive ERC-CBZ starting dose range from 100 to 200 mg b.i.d. and further titration up to a maximum dose of 1600 mg/day done at the discretion of the investigator. Titration phase will not extend beyond 2 weeks.Open label phase subjects stabilized on lithium and ERC-CBZ therapy will enter this phase for 6 months
16342462|NCT00325273|Dietary Supplement|Lactobacillus rhamnosus GG|use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
16342463|NCT00325260|Biological|Influvac; subunit influenza vaccine|
16342464|NCT00325247|Drug|ZINC|
16342465|NCT00325234|Drug|Pemetrexed|600 mg/m^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
16342466|NCT00325234|Drug|Carboplatin|AUC 5 mg*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
16342467|NCT00325234|Drug|Gemcitabine|1200 mg/m^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
16342468|NCT00325234|Drug|Vinorelbine|30 mg/m^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
16342469|NCT00325221|Device|HM on|Home Monitoring activated after implantation
16342470|NCT00325221|Device|HM Off|Home Monitoring activated 9 months after implantation
16342471|NCT00325208|Device|partial-vacuum milk bottle|
16342472|NCT00325208|Device|anti-vacuum milk bottle|
16342473|NCT00325195|Other|placebo|placebo by intravenous infusion every 2 weeks
16342474|NCT00325195|Biological|pegloticase|8 mg pegloticase by intravenous infusion
16342475|NCT00325182|Drug|Levetiracetam|
16342476|NCT00325182|Other|Historical controls|
16342477|NCT00325169|Drug|Tiotropium + SERETIDE 50/500|
16342478|NCT00325156|Biological|GSK Biologicals' combined DTPa-IPV/Hib vaccine|4 intramuscular injections
16342479|NCT00325143|Biological|DTPa-HBV-IPV/Hib|1 intramuscular injection (3rd study vaccine dose)
16342480|NCT00325143|Biological|DTPa-IPV/Hib vaccine|3 intramuscular injections (1st, 2nd and 4th vaccine dose)
16342481|NCT00325130|Biological|Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine|"Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a
~0.5-mL intramuscular dose at Day 1, Month 2, and Month 6."
16342482|NCT00325130|Biological|Comparator: Menactra™ (Concomitant)|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
16342483|NCT00325130|Biological|Comparator: Adacel™ (Concomitant)|a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
16342484|NCT00325130|Biological|Comparator: Menactra™ (Non-concomitant)|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
16342485|NCT00325130|Biological|Comparator: Adacel™|A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
16342486|NCT00325117|Drug|Vildagliptin|
16342490|NCT00325039|Procedure|retropubic mid-urethral sling (TVT)|This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
16342491|NCT00325039|Procedure|transobturator mid-urethral sling (TVT-O and the Monarc)|This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.
16342492|NCT00325026|Drug|Misoprostol|
16342493|NCT00325026|Device|Foley bulb|
16342494|NCT00325013|Drug|Docosahexaenoic Acid (DHA)|800mg twice a day for 1 year
16342495|NCT00325000|Behavioral|Interpersonal Psychotherapy|
16342496|NCT00325000|Drug|sertraline or amitriptyline|
16342497|NCT00324987|Biological|Bevacizumab|Given IV
16342498|NCT00324987|Drug|Imatinib Mesylate|Given PO
16342499|NCT00324987|Other|Laboratory Biomarker Analysis|Correlative studies
16342500|NCT00324987|Other|Pharmacological Study|Correlative studies
16342501|NCT00324974|Drug|Lansoprazole microgranules suspension|"Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks;
~Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks."
16342502|NCT00324974|Drug|Placebo|Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
16342503|NCT00324961|Drug|adefovir dipivoxil tablets|adefovir dipivoxil once daily 10 mg orally
16342504|NCT00324948|Drug|Topical alprostadil (PGE-1)|
16342505|NCT00324922|Drug|trimethoprim-sulfamethoxazole|trimethoprim/sulfamethoxazole 320/1600 mg po bid
16342506|NCT00324922|Drug|vancomycin|1g iv bid
16342507|NCT00324909|Drug|Hyperbaric Oxygen Therapy|
16342508|NCT00324896|Drug|eszopiclone|eszopiclone
16342509|NCT00324896|Other|placebo|matching placebo administered at night
16342510|NCT00324870|Drug|vorinostat|Given orally
16342511|NCT00324870|Drug|bevacizumab|Given IV
16342512|NCT00324857|Behavioral|Decision Aid Video|"The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
16342513|NCT00324857|Behavioral|Motivational Interviewing|The research intervention will conduct the fact-to-face MI session with the participant. The MI session will do the following things: 1) Assessing Readiness, Importance, and Confidence; 2) Eliciting Barriers, Concerns and Positive Motivational; 3) Summarizing Pros and Cons; 4) Assess Patient Values and Goals; 5) Provide a Menu of Options.
16342514|NCT00324857|Behavioral|MI plus Decision aid|Patient viewed the video and then underwent MI.
16342515|NCT00324857|Other|Attention control|patients received a booklet.
16342516|NCT00324831|Drug|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16342517|NCT00324831|Drug|cyclophosphamide|
16342518|NCT00324831|Drug|doxorubicin hydrochloride|
16342519|NCT00324831|Drug|prednisone|
16342520|NCT00324831|Drug|rituximab|
16342521|NCT00324831|Drug|sargramostim|
16342522|NCT00324831|Drug|vincristine|
16342523|NCT00324831|Procedure|Intervention/procedure|
16342524|NCT00324831|Procedure|antibody therapy|
16342525|NCT00324831|Procedure|biological therapy|
16342526|NCT00324831|Procedure|chemotherapy|
16342527|NCT00324831|Procedure|colony-stimulating factor therapy|
16342528|NCT00324831|Procedure|cytokine therapy|
16342529|NCT00324831|Procedure|monoclonal antibody therapy|
16342530|NCT00324831|Procedure|non-specific immune-modulator therapy|
16342531|NCT00324831|Procedure|therapeutic procedure|
16342532|NCT00324831|Procedure|tumor cell derivative vaccine|
16342533|NCT00324831|Procedure|vaccine therapy|
16342534|NCT00324818|Drug|metronidazole and azithromycin|
16342543|NCT00324792|Drug|intensive insulin therapy|
16342544|NCT00324779|Biological|rituximab|
16342545|NCT00324766|Drug|levosimendan|1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
16342546|NCT00324766|Drug|placebo,|24 h, infusion
16342547|NCT00324753|Behavioral|Communication|Communication sheet
16342548|NCT00324753|Behavioral|Standard of care|Standard of care brochures
16342549|NCT00324740|Drug|vorinostat|Given orally
16342550|NCT00324740|Drug|isotretinoin|Given orally
16342551|NCT00324727|Drug|melphalan|Given throug isolated hepatic artery infusion
16342552|NCT00324727|Drug|regional chemotherapy|Patients receive the best alternative therapy
16342553|NCT00324727|Drug|systemic chemotherapy|Patients receive the best alternative therapy
16342554|NCT00324727|Procedure|hepatic artery embolization|Patients receive the best alternative therapy
16342555|NCT00324714|Drug|risedronate sodium|
16342556|NCT00324714|Other|diagnostic laboratory biomarker analysis|
16342557|NCT00324701|Behavioral|Telepsychology|therapy done at patients house
16342558|NCT00324701|Behavioral|Face-to-face therapy|therapy delivered at the VAMC
16342559|NCT00324688|Drug|Viread|
16342560|NCT00324675|Drug|Rosiglitazone|4 mg tablets, bid, 12 months
16342561|NCT00324675|Drug|Placebo|2 tablets per day
16342563|NCT00324649|Drug|Truvada|Truvada once daily with continuation of the current NNRTI or PI at randomization.
16342564|NCT00324649|Drug|Zidovudine/lamivudine|Continuation of the zidovudine + lamivudine containing regimen plus the current NNRTI or PI at randomization.
16342565|NCT00324623|Biological|Melan-A VLP vaccine, IMP321 adjuvant|
16342566|NCT00324623|Biological|adoptive immunotherapy|
16342567|NCT00324623|Biological|therapeutic autologous lymphocytes|
16342568|NCT00324623|Drug|cyclophosphamide|
16342569|NCT00324623|Drug|fludarabine phosphate|
16342570|NCT00324610|Drug|capecitabine|
16342571|NCT00324597|Drug|gemcitabine hydrochloride|
16342572|NCT00324597|Drug|motesanib diphosphate|
16342573|NCT00324597|Other|pharmacological study|
16342574|NCT00324584|Device|Telemonitoring of glucose values using GlucoNet device|
16342575|NCT00324571|Drug|Sevelamer hydrochloride|
16342576|NCT00324571|Drug|Calcium-based phosphate binder|
16342577|NCT00324558|Drug|Bemiparin|subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)
16342578|NCT00324545|Behavioral|Medium-intensity Minimally-directive Counseling|
16342579|NCT00324532|Drug|ProBactrix|
16342580|NCT00324519|Device|Foley bulb|
16342581|NCT00324519|Drug|misoprostol|
16342582|NCT00324506|Drug|Mycophenolate Mofetil (CellCept)|
16342583|NCT00324480|Drug|alvocidib|Given IV
16342584|NCT00324480|Drug|vorinostat|Given orally
16342585|NCT00324480|Other|pharmacological study|Correlative studies
16342586|NCT00324467|Drug|Cyclophosphamide|"Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
16342587|NCT00324467|Drug|Doxorubicin|"Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
16342588|NCT00324467|Drug|Vincristine|"Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
16342589|NCT00324467|Drug|Prednisone|"Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17)
~* Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan"
16342590|NCT00324467|Drug|Ondansetron|Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy
16342591|NCT00324467|Drug|Dexamethasone|Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy
16342592|NCT00324467|Drug|Diphenhydramine|Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
16342593|NCT00324467|Drug|Acetaminophen|Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
16342594|NCT00324467|Drug|Ifosfamide|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3, over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
16342595|NCT00324467|Drug|Mesna (IV)|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3 (with ifosfamide) over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
16342596|NCT00324467|Drug|Mesna (oral)|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 2 g Administration: PO 2h and 4h after ifosfamide infusion on days 1,2,3 Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
16342597|NCT00324467|Drug|Carboplatin|"R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5 x (25+CrCl*) (maximum dose 800 mg) Administration: IV infusion day 1 over 1 hour Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
~*Carboplatin is dose via the Calvert formula with an AUC of 5, maximum dose 800 mg per cycle.
~Estimate Creatinine Clearance (CrCl)"
16342598|NCT00324467|Drug|Etoposide|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 100 mg/m^2 Administration: IV infusion day 1,2,3 over 30 minutes Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
16342599|NCT00324467|Drug|Rituximab|R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 375 mg/m^2 Administration: IV infusion day 1 (or day 2 or day 3) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)
16342600|NCT00324467|Drug|Ondansetron|Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily
16342601|NCT00324467|Drug|Dexamethasone|Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily
16342602|NCT00324467|Drug|Diphenhydramine|Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
16342603|NCT00324467|Drug|Acetaminophen|Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion
16342604|NCT00324467|Other|PET Scan|Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)
16342605|NCT00324454|Biological|Levetiracetam|Levetiracetam 1500 mg BID
16342606|NCT00324441|Device|Iratherm® 1000|
16342607|NCT00324428|Procedure|Transcranial Magnetic Stimulation|1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day
16342608|NCT00324415|Biological|cetuximab|400 mg/m2 IV Day -7 (1 week before the cycle 1, Day 1 cisplatin/5-FU and RT), then 250 mg/m2 IV Days 1, 8, 15, 22, 29, 36 and 43 (a minimum of 6 and a maximum of 8 doses of cetuximab will be administered, including the loading dose)
16342609|NCT00324415|Drug|cisplatin|75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2)
16342610|NCT00324415|Drug|fluorouracil|1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)
16342611|NCT00324415|Radiation|radiation therapy|Irradiation to tumor site and inguinal nodes beginning on cycle 1, Day 1 cisplatin/5-FU (minimum 45.0 Gy [5 weeks if given on schedule and without interruption], maximum 54.0 Gy [6 weeks if given on schedule and without interruption). IMRT may be used at the discretion of the treating physician.
16342612|NCT00324389|Drug|Interferon alpha|
16342613|NCT00324376|Drug|Sevelamer hydrochloride|
16342665|NCT00323869|Drug|Carboplatin|Alkylating agent
16342614|NCT00324363|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
16342615|NCT00324363|Drug|Placebo|subcutaneous injection twice daily in volumes equal to exenatide
16342616|NCT00324350|Drug|hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents|type 2 diabetes treatments, per standard of care
16342617|NCT00324324|Drug|moxifloxacin hydrochloride|Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
16342618|NCT00324324|Drug|Placebo|Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
16342619|NCT00324311|Drug|DGD|Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
16342620|NCT00324298|Biological|bleomycin sulfate|
16342621|NCT00324298|Drug|cisplatin|
16342622|NCT00324298|Drug|etoposide|
16342623|NCT00324298|Procedure|management of therapy complications|
16342624|NCT00324285|Drug|Amylase resistant starch added ORS|
16342625|NCT00324272|Drug|Fibrin Sealant (Tisseel) used in the Experimental Arm.|"For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK.
~For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects)."
16342626|NCT00324259|Drug|Estradiol|
16342627|NCT00324233|Device|Intermittent catheter|SpeediCath catherter (SC) for intermittent catherisation
16342628|NCT00324233|Device|Compact intermittent catheter|SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males
16342629|NCT00324220|Drug|MGCD0103|MGCD0103 Oral administration 3 times per week.
16342630|NCT00324194|Drug|MGCD0103|MGCD0103 oral dose given 2 times per week.
16342631|NCT00324168|Drug|Antibiotics|moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization
16342632|NCT00324168|Drug|Topical corticosteroid|prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
16342633|NCT00324168|Drug|Placebo|0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
16342634|NCT00324155|Drug|Ipilimumab|"Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent
~In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression"
16342635|NCT00324155|Drug|Placebo|Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent
16342636|NCT00324155|Drug|Dacarbazine|Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
16342637|NCT00324142|Drug|Oral tinidazole|
16342638|NCT00324129|Drug|MGCD0103|MGCD0103 given orally three times per week.
16342639|NCT00324116|Drug|pegaptanib sodium (Macugen)|0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
16342640|NCT00324103|Drug|Structured Treatment Interruptions|
16342641|NCT00324090|Behavioral|High and low glycemic index|
16342642|NCT00324077|Drug|Dasatinib in combination with imatinib|
16342643|NCT00324064|Procedure|GHRH/arginine stimulation testing|GHRH(Geref) 1mcg/kg IVP followed by Arginine 10% solution 0.5mg/kg (maximum of 30 Gm) infused over 30 minutes. Labs drawn 6 times over 2 hours.
16342644|NCT00324051|Drug|olanzapine therapy|
16342645|NCT00324038|Drug|Buprenorphine|buprenorphine transdermal system 5, 10 and 20 mg
16342646|NCT00324038|Drug|Codeine paracetamol|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
16342647|NCT00324025|Drug|Mycograb|
16342648|NCT00324025|Drug|placebo|
16342649|NCT00324012|Drug|cisplatin, taxotere|cisplatin 75 mg/m2 Taxotere 75 mg/m2
16342650|NCT00323999|Procedure|Hysteroscopic resection of fibroids, polyps and endometrium.|
16342651|NCT00323986|Drug|azithromycin (drug)|
16342652|NCT00323973|Drug|Bisoprolol|10 mg qd
16342653|NCT00323960|Drug|3 MPDN pulse + PDN|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
16342654|NCT00323960|Drug|3 MPDN pulse + PDN + CSA|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
16342655|NCT00323960|Drug|3 MPDN pulse + PDN + MTX|3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
16342656|NCT00323947|Drug|Extended Release Methylphenidate (OROS-Methylphenidate)|"Participants will first take either immediate release MPH or placebo A for 1 day. On Day 2 of treatment, participants assigned to receive XR-MPH will begin taking it, and participants assigned to receive placebo will switch to placebo B. This treatment phase will continue for 6 days to 4 weeks, depending on weight, and will then be followed by a 1-week medication washout period. Target dose depends on the weight of the participant. Possible dose forms include 18, 36, 54 mg OROS-MPH."
16342657|NCT00323934|Drug|MGCD0103|Oral dosage 2 times weekly.
16342658|NCT00323921|Device|dermatological infrared laser|
16342659|NCT00323895|Device|drug-eluting stent and balloon angioplasty|CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
16342660|NCT00323895|Device|drug-eluting stent and balloon angioplasty|CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
16342661|NCT00323895|Device|drug-eluting stent|CYPHER Select ™ Sirolimus-eluting Stent
16342662|NCT00323882|Drug|MDX-010|selected dose administered IV every 3 weeks
16342663|NCT00323869|Drug|Bevacizumab|Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
16342666|NCT00323856|Drug|Alphanate SD/HT|Plasma-derived preparation of Factor VIII
16342667|NCT00323843|Drug|Isoproterenol|
16342668|NCT00323830|Drug|Capecitabine, cisplatin, Radiotherapy (+/-)|Capecitabine, cisplatin + Radiotherapy (randomized)
16342669|NCT00323817|Drug|Z-338|
16342670|NCT00323804|Biological|Peginterferon alfa-2b|PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
16342671|NCT00323804|Drug|Ribavirin|Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36
16342672|NCT00323804|Drug|Ribavirin-Placebo|Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36
16342673|NCT00323791|Drug|gemcitabine hydrochloride|
16342674|NCT00323791|Drug|imatinib mesylate|
16342675|NCT00323791|Genetic|gene expression analysis|
16342676|NCT00323791|Genetic|protein expression analysis|
16342677|NCT00323791|Other|immunohistochemistry staining method|
16342678|NCT00323791|Other|laboratory biomarker analysis|
16342679|NCT00323778|Drug|Hyalgan|
16342680|NCT00323752|Procedure|rHuEpo|Subjects will be randomly assigned to either participate in the PAD program or receive the rHuEpo treatment. Subjects in the PAD group will donate 1 unit of blood at -14 and -7 days prior to surgery. A dose of 500 IU of rHuEpo will be administered subcutaneously to subjects in the rHuEpo group at -21, -14, and -7 days prior to surgery.
16342681|NCT00323739|Drug|bevacizumab|Bevacizumab 10mg/kg, IV infusion, every 2 weeks
16342682|NCT00323739|Drug|RAD001|RAD001 10 mg by mouth daily
16342683|NCT00323713|Behavioral|Very low protein diet|0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
16342684|NCT00323713|Behavioral|Low protein diet|0.6 g of protein per kilo of body weight per day
16342685|NCT00323687|Drug|Truvada|300mg / 200 mg QD tenofovir DF and Emtricitabine Fixed Dose Combination (FDC) Tablet (oral)
16342686|NCT00323674|Device|Polysoft Mesh|Polysoft Mesh is used.
16342687|NCT00323674|Device|Light Weight Mesh|Light Weight Mesh is used.
16342688|NCT00323661|Device|Rate-adaptive pacemaker: accelerometer|Accelerometer based pacing rate adaptation
16342689|NCT00323661|Device|Rate-adaptive pacemaker: Closed Loop Stimulation|Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity.
16342690|NCT00323648|Drug|Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis|Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis.
16342691|NCT00323635|Drug|tolterodine|tablet, 4 mg, daily, 1 month
16342692|NCT00323622|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|IM injection in the deltoid muscle
16342693|NCT00323622|Biological|Engerix™-B|IM injection in the deltoid muscle
16342694|NCT00323622|Biological|Hiberix®|IM injection in the deltoid muscle
16342695|NCT00323622|Biological|Prevnar™|IM injection in the deltoid muscle
16342696|NCT00323622|Drug|sulfadoxine-pyrimethamine|1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
16342697|NCT00323622|Drug|amodiaquine|1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
16342698|NCT00323609|Procedure|Vertebroplasty|Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
16342699|NCT00323609|Procedure|Kyphoplasty|Balloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement.
16342700|NCT00323596|Behavioral|physical activity program of strength and balance retraining|
16342701|NCT00323583|Drug|paclitaxel|
16342702|NCT00323583|Drug|oxaliplatin|
16342703|NCT00323583|Drug|leucovorin|
16342704|NCT00323583|Drug|5-fluorouracil|
16342705|NCT00323583|Drug|glutathione|
16342706|NCT00323583|Drug|calcium and magnesium|
16342707|NCT00323583|Procedure|Chemotherapy|
16342708|NCT00323583|Procedure|Chemoprotection|
16342709|NCT00323583|Procedure|Complementary and alternative therapy|
16342710|NCT00323570|Drug|activated recombinant human factor VII|
16342711|NCT00323557|Drug|Sargramostim (GM-CSF)|Starting with 3 doses of 250 micrograms subcutaneously, either pre or post vaccine. For pre vaccine, GM-CSF on days -7 (+ 1 day) and -3 (+ 1 day), in the week prior to vaccination for pre-vaccination immune priming; 3rd dose on the day of vaccination (day 0); and for post-vaccine GM-CSF given simultaneously on day of vaccination (day 0) and 2 more doses Day +3 and Day +7 after pneumococcal vaccine.
16342712|NCT00323557|Biological|Pneumococcal Vaccine|Subcutaneously on Day 0
16342713|NCT00323544|Drug|zidovudine and lamivudine (Combivir®)|
16342714|NCT00323544|Drug|emtricitabine and tenofovir DF|
16342715|NCT00323531|Procedure|Chest tube with tPA infusion for 3 days|fibrinolysis through the chest tube
16342716|NCT00323531|Procedure|VATS decortication|thoracoscopic decortication
16342717|NCT00323518|Drug|velafermin|administered intravenously as 100mL single dose over 15 minutes on day 1
16342718|NCT00323518|Drug|placebo|administered intravenously as 100mL single dose over 15 minutes on day 1
16342719|NCT00323505|Drug|Pegylated Interferon|
16342720|NCT00323505|Drug|Interferon-alpha2a|
16342721|NCT00323492|Drug|Truvada|Truvada + NNRTI or PI.
16342722|NCT00323492|Drug|Current HAART regimen|Maintain baseline regimen
16342723|NCT00323479|Drug|Anastrozole|1mg/Day oral
16342724|NCT00323466|Procedure|IMRT versus conventional radiotherapy|Comparing MRT versus conventional radiotherapy
16342725|NCT00323453|Device|Open appendectomy using Alexis Wound Retractor followed by standardized wound closure|The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
16342726|NCT00323453|Procedure|Open appendectomy with standardized wound closure|The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
16342727|NCT00323427|Behavioral|The Living Well with Hearing Loss Workshop|Interactive group session modeled on Patient-Centered medicine and Adult Learning principles; the participants are partners with the Group Facilitator who is a hearing rehabilitation professional
16342728|NCT00323427|Device|hearing aid services|Standard VA audiological hearing aid dispensing services
16342729|NCT00323414|Drug|Polyunsaturated fatty acid (Opti-EPA)|Active experimental arm to patients with diabetes mellitus and non alcoholic steatohepatitis: Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)[360 mg EPA and 240 DHA in each capsule] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks
16342730|NCT00323414|Drug|Placebo|Placebo gelcaps containing corn oil identical to the PUFA gelcaps 6 capsules-3 capsules by mouth 2x per day x 48 weeks
16342731|NCT00323401|Other|Antenatal classes|3 sessions of 3 hours each
16342732|NCT00323375|Drug|AQ-13|A treatment dose of AQ-13 (1750 mg base) was administered orally to subjects randomized to AQ-13 over 3 days (as two capsules on days 1 and 2, plus one capsule on day 3).
16342733|NCT00323375|Drug|Chloroquine (CQ) Treatment|A treatment dose of CQ (1500 mg CQ base) was administered orally to subjects randomized to CQ over 3 days (as two capsules on days 1 and 2, and one capsule on day 3).
16342734|NCT00323362|Drug|gemcitabine hydrochloride|1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
16342735|NCT00323362|Drug|imatinib mesylate|400 mg/day orally, given Days 1-5 and 8-12 every 21 days
16342736|NCT00323349|Procedure|Oral Glucose Tolerance Testing|
16342737|NCT00323349|Behavioral|Education tailored to learning style preferences|
16342738|NCT00323323|Drug|CHOP|CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.
16342739|NCT00323323|Drug|Alemtuzumab|Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.
16342740|NCT00323323|Procedure|Plasma Samples|Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.
16342741|NCT00323310|Drug|gadobenate dimeglumine|A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
16342742|NCT00323297|Drug|Bosentan|Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
16342743|NCT00323297|Other|Placebo|Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
16342744|NCT00323297|Drug|Bosentan|Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
16342745|NCT00323297|Drug|Sildenafil Citrate|Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
16342746|NCT00323284|Device|iStent plus Cataract Surgery|ab interno trabecular bypass stent surgery
16342747|NCT00323284|Procedure|Cataract surgery only|Cataract surgery only
16342748|NCT00323271|Behavioral|Cognitive-behavior therapy|CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).
16342749|NCT00323271|Other|Interventional|Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.
16342750|NCT00323258|Behavioral|oral education & written tips for remembering medications|Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, Angiotensin Converting Enzyme Inhibitor (ACEI)/Angiotensin Receptor Blocker (ARB), aspirin, and other anti-platelets) with the subject. A written list of tips for remembering medications will be provided and reviewed.
16342751|NCT00323258|Device|pill box|Subject is provided a pill box and briefly instructed on how to use the box.
16342752|NCT00323258|Device|pocket medication card|Subject is provided with a card that contains space for prescription and non-prescription medications. If desired the clinical pharmacist-investigator will complete the card for the subject.
16342753|NCT00323258|Behavioral|sharing information with community pharmacist|A fax is sent to the designated community pharmacy at the time of the subject's discharge from the hospital. The fax contains the subject's medications of interest, barriers to medication adherence, and physicians' contact information.
16342754|NCT00323258|Behavioral|Medication use evaluations by community pharmacist|The community pharmacist will assess use of medications of interest at time of first medication fill and by reviewing the subject's computerized medication profile at the pharmacy. Assessments occur at first visit to pharmacy, 6-weeks, 12-weeks, 18-weeks, and 24-weeks. If there are issues with any medications of interest the subject will be called. If needed, the subject's health care team will be notified.
16342755|NCT00323258|Behavioral|informing physician if patient has stopped a medication|The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.
16342756|NCT00323258|Behavioral|Routine discharge counseling|Both groups received routine discharge counseling performed by the patient-care nurse.
16342757|NCT00323258|Other|Letter to physician/discharge summary|A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.
16342758|NCT00323245|Behavioral|Physiotherapy for urinary incontinence|See Detailed Description.
16342759|NCT00323232|Device|2 Versus 4 Hole DHS|See Detailed Description.
16342760|NCT00323219|Drug|Cefazolin and Moxifloxacin|See Detailed Description.
16342761|NCT00323206|Biological|IL-12p DNA|Plasmid IL-12 will be administered as an intratympanic (IT) injection.
16342901|NCT00322023|Drug|D-serine|
16342902|NCT00322023|Drug|D-serine|
16342762|NCT00323206|Procedure|Intratumoral Electroporation|The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.
16342763|NCT00323193|Behavioral|MOVE!|group based psychoeducation, motivation and support
16342764|NCT00323154|Drug|Nalbuphine|
16342765|NCT00323141|Device|Ventralex versus Leight Weight Vypro II prothesis|Ventralex and Leight Weight Vypro II prothesis are compared.
16342766|NCT00323128|Procedure|Calculation of inuline clearance|Calculation of inuline clearance.
16342767|NCT00323128|Procedure|Measuring serum creatinine|Measuring serum creatinine.
16342768|NCT00323115|Biological|Autologous Dendritic Cell|Vaccine given by cervical lymph node injection 3 times every other week
16342769|NCT00323115|Drug|Temozolomide|Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC
16342770|NCT00323115|Procedure|Radiotherapy|RT is standard of care (SOC) post surgery
16342771|NCT00323115|Biological|Dendritic Cell Vaccine|Vaccine given cervical lymphnode injection 3 times every other week
16342772|NCT00323102|Drug|Multihance|
16342773|NCT00323089|Procedure|microcoil insertion and excision|The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
16342774|NCT00323076|Drug|18F-FAZA PET Imaging|"Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient.
~Phase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient."
16342775|NCT00323063|Drug|gemcitabine hydrochloride|Given IV
16342776|NCT00323063|Drug|imatinib mesylate|Given orally
16342777|NCT00323050|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
16342778|NCT00323037|Drug|carvedilol controlled release|Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.
16342779|NCT00323037|Drug|carvedilol immediate release|Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
16342780|NCT00323024|Drug|NX1011|
16342781|NCT00323011|Drug|Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab|
16342782|NCT00322985|Drug|Lenalidomide|25 mg/day, orally for 21 days with 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day.
16342783|NCT00322972|Drug|Mass treatment with oral azithromycin to an entire community|For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. For study arm C and D, nasopharyngeal swabs will be collected from 10 randomly selected children among the 60 participants under 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.
16342784|NCT00322946|Biological|rDEN4delta30-4995|Live attenuated rDEN4delta30-4995 vaccine (one of three doses)
16342785|NCT00322946|Biological|Placebo|Placebo for rDEN4delta30-4995
16342786|NCT00322933|Procedure|renal replacement therapy (intermittent or continuous)|
16342787|NCT00322920|Drug|Topotecan|
16342788|NCT00322920|Drug|Cisplatin|
16342789|NCT00322907|Drug|Cotrifazid vs mefloquine or quinine+SP|
16342790|NCT00322881|Drug|Paclitaxel|
16342791|NCT00322881|Drug|Carboplatin|
16342792|NCT00322868|Drug|pioglitazone|All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
16342793|NCT00322842|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
16342794|NCT00322803|Drug|ELB139|
16342795|NCT00322777|Behavioral|Spirituality Teaching Program|The Spirituality Teaching Program is a home study program delivered through audio CDs over an 8-week period. The program consists of weekly 90 minute teaching sessions, based on the content of a workshop developed to assist users in developing a more spiritual outlook on life and coping resources. Using didactic comment and storytelling, the following spiritual concepts are addressed in the sessions: self-transcendence, connectedness, forgiveness, self-acceptance, detachment, compassion and gratitude. Each session concludes with a relevant guided visualization practice. In addition, a 15-minute progressive relaxation exercise is included that is to be used on a daily basis. The presented content is nondenominational to ensure compatibility with any beliefs participants may hold.
16342796|NCT00322764|Drug|Uridine|
16342797|NCT00322751|Drug|Topotecan|The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.
16342798|NCT00322699|Procedure|Whole bladder laser light treatment as an alternative to radical cystectomy|The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.
16342799|NCT00322699|Drug|Photofrin|The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.
16342800|NCT00322686|Drug|Oglemilast|Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
16342801|NCT00322686|Drug|Placebo then Oglemilast|Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
16343215|NCT00319215|Drug|Zopiclone 7.5 mg|
16342802|NCT00322673|Drug|XL999|XL999 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study
16342803|NCT00322660|Drug|Adrenaline|
16342804|NCT00322621|Drug|Duloxetine|
16342805|NCT00322608|Drug|NPI-2358|Treatment on Days 1, 8 and 15 in a 28 day cycle
16342806|NCT00322595|Drug|Quetiapine fumarate|
16342807|NCT00322595|Drug|Paroxetine|
16342808|NCT00322569|Device|Corio™ Pimecrolimus-Eluting Coronary Stent System|Drug-eluting stent
16342809|NCT00322569|Device|SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System|Drug-eluting stent
16342810|NCT00322569|Device|Costar ™ Paclitaxel-Eluting Coronary Stent System|Drug-eluting Stent
16342811|NCT00322556|Drug|Immunoglobulins Intravenous (Human)|Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
16342812|NCT00322543|Device|Corio™ Pimecrolimus-eluting stent|
16342813|NCT00322530|Procedure|Renal replacement therapy|ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED
16342814|NCT00322517|Drug|SU014813|100 mg capsule/day for 6 cycle of 21 days
16342815|NCT00322504|Procedure|Accupuncture|
16342816|NCT00322491|Drug|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
16342817|NCT00322478|Behavioral|Automated informatics driven education and social networking|The patient uses a self-contained wireless accessory to a standard blood glucose meter. This device manages the meter to ensure accurate time stamps and transmits the data to a centralized data management system. The system is then configured to assess the data and take automated steps to derive relevant diabetes education and/or send reports to a registered and authorized team.
16342818|NCT00322478|Behavioral|Blood Glucose Notifications to Remote Caregivers|When children with type 1 diabetes are at school they will connect their blood glucose meter to the GlucoMON appliance. The data from the meter is then transmitted to the central system followed by the most recent blood sugar being sent to the primary caregiver's email address(es) as a plain text message. The investigator is interested to better understand the behaviors that accompany the expectation of the message and actions taken subsequent to receipt of the message by the patient-centric team.
16342819|NCT00322478|Behavioral|Frequency of Pattern Management|The behavioral intervention being studied involves the assessment of frequency of self-care in relation to the primary and secondary outcomes including overall blood sugar control and patient satisfaction.
16342820|NCT00322465|Drug|Tinidazole|2 gm single dose (4 tablets orally at 500 mg each).
16342821|NCT00322465|Other|Placebo|Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.
16342822|NCT00322465|Drug|Doxycycline|100 mg orally, twice daily for 7 days.
16342823|NCT00322465|Drug|Azithromycin|1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).
16342824|NCT00322452|Drug|Gefitinib|oral tablet
16342825|NCT00322452|Drug|Carboplatin|IV
16342826|NCT00322452|Drug|Paclitaxel|IV
16342827|NCT00322439|Drug|Etanercept|Observational study - no drug administered
16342828|NCT00322426|Device|Sensory Cueing Device|
16342829|NCT00322413|Drug|Epoetin|
16342830|NCT00322400|Drug|Docetaxel|Subjects assigned to Arm B, cohorts will receive 75 or 100 mg/m2 of docetaxel (based on cohort assignment) on Day 1 repeated every 21 days (1 cycle). AMG 706 will be administered concurrently on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond.
16342831|NCT00322400|Drug|Paclitaxel|Subjects assigned to Arm A will receive 90 mg/m2 of paclitaxel on Days 1, 8 and 15 repeated every 28 days (1 cycle). On Arm A, AMG 706 will be concurrently administered on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond.
16342832|NCT00322400|Drug|AMG 706|"Subjects assigned to Arm A will receive AMG 706 at 50, 75, 100 or 125 mg daily (based on cohort assignment) on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond in combination wth paclitaxel 90 mg/m2. Paclitaxel will be administered on Days 1, 8 and 15 every 28 days.
~Subjects assigned to Arm B will receive AMG 706 at 50, 75, 100 or 125 mg daily(based on cohort assignment) on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond in combination with docetaxel. Docetaxel will be administered at either 75 mg/m2 or 100 mg/m2 on Day 1 every 21 days."
16342833|NCT00322387|Drug|G-CSF and plerixafor|G-CSF and plerixafor were administered as described in the treatment arms.
16342834|NCT00322374|Drug|Ixabepilone|Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.
16342835|NCT00322374|Drug|Epirubicin|Infusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².
16342836|NCT00322361|Biological|Comparator: RECOMBIVAX HB™|RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
16342837|NCT00322361|Biological|Comparator: Modified process Hepatitis B Vaccine|Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
16342838|NCT00322348|Drug|Goserelin acetate|3.6 mg intramuscular depot injection given every 4 weeks
16342839|NCT00322348|Drug|Goserelin acetate|10.8 mg intramuscular depot injection given every 12 weeks
16342840|NCT00322335|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
16342841|NCT00322335|Biological|Infanrix™ penta|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
16342842|NCT00322335|Biological|Infanrix™ hexa|Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
16342843|NCT00322335|Biological|Engerix-B|Intramuscular injection into the thigh as a birth dose
16355458|NCT00219154|Drug|aliskiren|
16342844|NCT00322335|Biological|NeisVac-C™|Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
16342845|NCT00322335|Biological|Infanrix™ IPV/HIB|Intramuscular injection into the thigh as primary vaccination at 4 months of age
16342846|NCT00322335|Biological|Meningitec™|Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
16342847|NCT00322322|Drug|L-Carnitine|L-Carnitine
16342848|NCT00322309|Other|Placebo|Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84
16342849|NCT00322309|Drug|Mirtazapine|Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
16342850|NCT00322296|Drug|Bexarotene 1% gel|
16342851|NCT00322283|Drug|Oglemilast|Oglemilast, 15mg once per day, oral administration
16342852|NCT00322283|Drug|Placebo|Dose-marched placebo, once per day, oral administration
16342853|NCT00322270|Drug|Alfimeprase|single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
16342854|NCT00322257|Drug|inhaled human insulin|Treat-to-target dose titration scheme, inhalation.
16342855|NCT00322257|Drug|insulin detemir|Injection s.c., 50% of daily dose
16342856|NCT00322257|Drug|insulin aspart|Treat-to-target dose titration scheme, injection s.c.
16342857|NCT00322244|Procedure|Massage Therapy|
16342858|NCT00322231|Biological|zoster vaccine live (ZOSTAVAX™)|1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
16342859|NCT00322231|Biological|Comparator: Placebo|1 dose 0.65 mL/dose subcutaneous injection of placebo.
16342860|NCT00322218|Drug|Zevalin Therapeutic Regimen|Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
16342861|NCT00322218|Other|Observation|Observation
16342862|NCT00322205|Drug|zyban|
16342863|NCT00322192|Behavioral|Conventional UK Physical therapy|
16342864|NCT00322192|Behavioral|Increased intensity of UK conventional physical therapy|
16342865|NCT00322192|Behavioral|UK conventional physical therapy plus functional strength training|
16342866|NCT00322166|Other|Sunlight|Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week.
16342867|NCT00322166|Other|Sunlight and calcium|Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week. In the calcium and sunlight arm, calcium supplements (Caltrate, 600mg elemental calcium, Whitehall) will be administered to the whole group via the Blister/ Webster packs.
16342868|NCT00322166|Other|control|Subjects in the control group will be provided with a brochure about vitamin D deficiency and how to treat it. They will receive their usual routine care and nutrition.
16342869|NCT00322153|Drug|memantine ER|28mg(7mg capsules) once daily and oral administration for 24 weeks.
16342870|NCT00322153|Drug|Placebo|Matching placebo oral administration once daily.
16342871|NCT00322140|Drug|CDDO|
16342872|NCT00322127|Drug|AMD3100|a 2 mL clear glass vial containing 1.7 mL of a sterile isotonic solution.
16342873|NCT00322114|Dietary Supplement|lycopene|Given orally
16342874|NCT00322114|Other|placebo|Given orally
16342875|NCT00322101|Radiation|total-body irradiation|Radiation
16342876|NCT00322101|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
16342877|NCT00322101|Drug|cyclophosphamide|Given IV
16342878|NCT00322101|Drug|mycophenolate mofetil|Given orally
16342879|NCT00322101|Drug|busulfan|Given IV or orally
16342880|NCT00322101|Drug|cyclosporine|Given IV or orally
16342881|NCT00322101|Drug|fludarabine phosphate|Given IV
16342882|NCT00322101|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
16342883|NCT00322101|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic transplantation
16342884|NCT00322101|Other|laboratory biomarker analysis|Correlative studies
16342885|NCT00322101|Genetic|cytogenetic analysis|Correlative studies
16342886|NCT00322101|Other|flow cytometry|Correlative studies
16342887|NCT00322101|Genetic|fluorescence in situ hybridization|Correlative studies
16342888|NCT00322101|Other|pharmacological study|Correlative studies
16342889|NCT00322101|Genetic|polymorphism analysis|Correlative studies
16342890|NCT00322101|Drug|tacrolimus|Given IV or orally
16342891|NCT00322101|Drug|methotrexate|Given IV
16342892|NCT00322075|Drug|insulin glargine|
16342893|NCT00322062|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|2L gut lavage solution
16342894|NCT00322062|Drug|Sodium Phosphate Solution|1 x 45ml solution, BID
16342895|NCT00322049|Biological|Tetravalent live attenuated dengue vaccine|"DEN candidate vaccine: One dose of the tetravalent, live attenuated DEN vaccine candidate, F17, contains dengue serotype 1, 2, 3 and 4 vaccines. This formulation contains 50 mcg/mL neomycin base, 5.5% lactose, and 1.9 g/dL human serum albumin; for subcutaneous injection.
~Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand.
~All infants subsequently received an inactivated JE vaccine approximately one and 1.5 months following dengue vaccine dose 2. The licensed JE vaccine in liquid form, was dosed at 0.25 ml for subcutaneous injection.
~A booster dose of DEN vaccine was given to all subjects previously vaccinated with DEN vaccine in Dengue -001. The booster dose was administered approximately 42 months after dose 2 (at the Year 3 visit)."
16342896|NCT00322049|Biological|Varicella vaccine and Haemophilus influenzae Type b Conjugate vaccine|Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand.
16342897|NCT00322036|Drug|MPC-7869|Oral 800 mg BID
16342898|NCT00322036|Drug|MPC-7869|Oral BID dosing
16342899|NCT00322023|Drug|D-serine|D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.
16342900|NCT00322023|Drug|D-serine|
16342903|NCT00322010|Procedure|early PT OT|"Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions).
~Sessions began with active assisted and active range of motion exercises in the supine position.
~If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting.
~Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
~The session progresses to transfer training, and finally pre-gait exercises and ambulation.
~Progression of activities is dependent on patient tolerance and stability.
~Therapy intervention continues on a daily basis throughout the patient's hospital stay until he/she returns to prior level of function or is discharged."
16342904|NCT00321997|Drug|Pegaptanib sodium|
16342905|NCT00321984|Drug|Dexlansoprazole MR|Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
16342906|NCT00321984|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
16342907|NCT00321984|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
16342908|NCT00321971|Behavioral|PST-MCI/AD Caregiving|The PST-based intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
16342909|NCT00321971|Behavioral|NT-MCI/AD Caregiving|The nutritional education program will be based on the new USSDA dietary recommendations. Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver's home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.
16342910|NCT00321958|Device|CSA System (CryoSpray AblationTM System)|10 second spray times
16342911|NCT00321958|Device|CryoSpray Ablation|10 second spray times
16342912|NCT00321945|Procedure|ACE-Inhibitors and Angiotensin Receptor Blockers|Retrospective study - no intervention as part of study.
16342913|NCT00321932|Dietary Supplement|calcium|All randomized patients (control and study drug) will take 1000 mg of calcium and 400 - 500 International Units (IU) of vitamin D orally each day, beginning as soon as possible after study enrollment. These supplements may be taken either in the morning or in the evening with food. Participants will continue taking the supplements on a daily basis until the final study visit (approximately 12 months after the transplant date).
16342914|NCT00321932|Dietary Supplement|cholecalciferol|Given orally
16342915|NCT00321932|Drug|zoledronic acid|Zoledronic acid (Zometa®) will be administered after randomization (but within 28 days prior to transplant) and at 3 and 6 months after the transplant for a total of 3 doses. The dose of Zometa will be 4 mg intravenous in 100 ml of sterile 0.9% sodium chloride, United States Pharmacopeia (USP), or 5% dextrose, USP infused over a minimum of 15 minutes for patients with a calculated creatinine clearance of ≥60 mL/min. The drug may be administered through a peripheral or a central intravenous line.
16342916|NCT00321919|Drug|epoetin beta [NeoRecormon]|Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
16342917|NCT00321919|Drug|epoetin beta [NeoRecormon]|Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to <10.5 g/dL had occurred.
16342918|NCT00321906|Drug|azathioprine|azathioprine 2mg/kg
16342919|NCT00321906|Drug|sirolimus|sirolimus 2-4mg daily
16342920|NCT00321893|Drug|Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for one year.
16342921|NCT00321893|Other|Placebo|Inhaled placebo twice daily for one year.
16342922|NCT00321880|Procedure|therapeutic touch|administration of healing touch in 30 minute sessions
16342923|NCT00321867|Procedure|Graft augmented posterior repair|Posterior repair with graft
16342924|NCT00321867|Procedure|Control|Native tissue repair
16342925|NCT00321854|Drug|pramipexole|
16342926|NCT00321828|Biological|bevacizumab|bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression
16342927|NCT00321828|Drug|fluorouracil|5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression
16342928|NCT00321828|Drug|leucovorin|leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
16342929|NCT00321828|Drug|oxaliplatin|Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
16342930|NCT00321815|Drug|PF-3512676 + Erlotinib|"PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity.
~Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity"
16342931|NCT00321815|Drug|Erlotinib|Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
16342932|NCT00321802|Drug|Simvastatin|Patients take 40 mg of simvastatin per day for 6 months.
16342933|NCT00321802|Drug|Placebo|Placebo
16342934|NCT00321789|Behavioral|spouse-assisted intervention|Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.
16342935|NCT00321763|Biological|Candidate Influenza Vaccine GSK1247446A - 3 different formulations|Single dose, Intramuscular injection
16342936|NCT00321763|Biological|Fluarix TM|Single dose, Intramuscular injection
16342937|NCT00321750|Drug|1% pimecrolimus cream|
16342938|NCT00321737|Drug|Dexlansoprazole MR|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
16342939|NCT00321737|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
16342940|NCT00321737|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
16342941|NCT00321724|Drug|cediranib maleate|Given orally
16342942|NCT00321724|Other|laboratory biomarker analysis|Correlative studies
16342943|NCT00321711|Drug|Placebo|Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.
16342944|NCT00321711|Biological|AMG 531 (Romiplostim)|AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization.
16342945|NCT00321711|Drug|Azacitidine|hypomethylating agent
16342946|NCT00321711|Drug|Decitabine|hypomethylating agent
16342947|NCT00321698|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Group 1=radiation only; All men in all Arms/Groups receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
16342948|NCT00321698|Drug|Docetaxel+IMRT|"Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation; Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation
~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
16342949|NCT00321685|Biological|Bevacizumab|Given IV
16342950|NCT00321685|Drug|Capecitabine|Given PO
16342951|NCT00321685|Drug|Fluorouracil|Given IV
16342952|NCT00321685|Drug|Leucovorin Calcium|Given IV
16342953|NCT00321685|Drug|Oxaliplatin|Given IV
16342954|NCT00321685|Radiation|Radiation Therapy|Undergo radiotherapy
16342955|NCT00321685|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16342956|NCT00321672|Drug|NGX-4010, 8% capsaicin patch|Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
16342957|NCT00321672|Drug|0.04% capsaicin patch|Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
16342958|NCT00321672|Drug|NGX-4010, 8% capsaicin patch|Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.
16342959|NCT00321672|Drug|0.04% capsaicin patch|Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.
16342960|NCT00321659|Behavioral|Aerobic|3x/week of walking and cycling
16342961|NCT00321659|Behavioral|Strength training|3x/week of resistance training activities
16342962|NCT00321659|Behavioral|Combination|3x/week of aerobic and strength training activities
16342963|NCT00321659|Behavioral|FSHC|Biweekly group education group meetings
16342964|NCT00321646|Drug|Bevacizumab|Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.
16342965|NCT00321646|Drug|Docetaxel|Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
16342966|NCT00321633|Drug|carboplatin|
16342967|NCT00321633|Drug|docetaxel|
16342968|NCT00321620|Drug|zoledronic acid|Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
16342969|NCT00321620|Biological|denosumab|Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes
16342970|NCT00321594|Drug|belinostat|Given IV
16342971|NCT00321581|Drug|Cediranib, AZD2171, RECENTIN|
16342972|NCT00321555|Drug|Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin|LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium Chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.
16342973|NCT00321542|Other|Imaging study, No intervention|Imaging with coronary computed tomographic angiography
16342974|NCT00321529|Device|motion analysis by durometer|
16342975|NCT00321516|Drug|aripiprazole|Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
16342976|NCT00321490|Drug|Quetiapine fumarate|
16342977|NCT00321490|Drug|Duloxetine|
16342978|NCT00321477|Drug|GW679769 oral tablets|
16342979|NCT00321464|Biological|Denosumab|Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
16342980|NCT00321464|Drug|Zoledronic Acid|Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
16342981|NCT00321451|Behavioral|Cognitive behavioral therapy for insomnia|4 biweekly outpatient sessions with sleep psychologist
16342982|NCT00321451|Behavioral|Pseudo-desensitization procedure|4 biweekly outpatient visits with sleep psychologist
16342983|NCT00321451|Other|Usual care|3 outpatient visits with study physician
16342984|NCT00321425|Procedure|brachial plexus block|
16342985|NCT00321425|Procedure|ultrasound guidance|
16342986|NCT00321425|Procedure|electrical nerve stimulation|
16342987|NCT00321412|Drug|AST-120|oral, sachet, 2 grams three times daily for 8 weeks
16342988|NCT00321373|Biological|Candidate Influenza Vaccine GSK1247446A - 2 different formulations|Single dose, Intramuscular injection
16342989|NCT00321373|Biological|FluarixTM|Single dose, Intramuscular injection
16342990|NCT00321360|Drug|Propofol|
16342991|NCT00321360|Device|Patient maintained sedation|
16342992|NCT00321347|Drug|Lidocaine|
16342993|NCT00321334|Procedure|Chemotherapy+Surgery|Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles
16342994|NCT00321321|Drug|Sulfonylurea|
16342995|NCT00321308|Drug|pemetrexed|500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
16342996|NCT00321308|Drug|pemetrexed + PF-3512676|pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
16342997|NCT00321295|Device|Atrial synchronous bi-ventricular pacing|
16342998|NCT00321282|Procedure|Atrial Fibrillation|
16342999|NCT00321269|Behavioral|Single Illness Management|8 week nursing intervention addressing Congestive Heart Failure
16343000|NCT00321269|Behavioral|Comorbid Illness Management|8 week nursing intervention to address Congestive Heart Failure and emotional coping
16343001|NCT00321256|Procedure|human pancreatic islet transplantation|
16343002|NCT00321243|Behavioral|Visual clues|
16343003|NCT00321230|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|
16343004|NCT00321204|Procedure|TZD reducing the incidence of atrial arrhythmias|
16343005|NCT00321191|Drug|No nitrous oxide|
16343006|NCT00321191|Drug|Administration of N2O|
16343007|NCT00321178|Drug|SR4 - switch to CR4|switch to oral treatment after 4 weeks SR 'standard' therapy
16343008|NCT00321165|Drug|taurolidine|
16343009|NCT00321152|Other|6(S)-5-MTHF (a Medical Food)|The study consists of 8 visits over a period of 8 weeks or 60 days. Eligible participants will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). Participants will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. At the end of the double-blind phase, both responders and non-responders who have completed the 8 week study will have the option of receiving free, open-label adjunctive treatment with either 7.5 mg or 15 mg of 6(S)-5-MTHF for 12 months. Subjects who agree to receive open-label treatment with 6(S)-5-MTHF for 12 months will be assessed every three (3) months until the end of the follow-up phase.
16343010|NCT00321126|Drug|Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks.|
16343011|NCT00321113|Drug|tacrolimus|immunosuppression
16343012|NCT00321113|Drug|mycophenolate mofetil|oral
16343013|NCT00321113|Drug|steroids|oral
16343014|NCT00321100|Drug|bevacizumab|Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
16343015|NCT00321100|Drug|Cetuximab|Cetuximab 250mg/m2 IV weekly each 21 day cycle
16343016|NCT00321100|Drug|Oxaliplatin|Oxaliplatin 130mg/m2 IV day 1 every 21 days
16343017|NCT00321100|Drug|Capecitabine|Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
16343018|NCT00321087|Drug|T2000|Dose escalation from 600 to 1000 mg
16343019|NCT00321087|Drug|T2000|Placebo followed by T2000 dose escalation from 600 to 1000 mg
16343020|NCT00321087|Drug|T2000|Placebo followed by dose escalation from 600 to 1000
16343021|NCT00321074|Drug|TACROLIMUS|Immunosuppression
16343022|NCT00321061|Drug|VRC-HIVDNA016-00, VRC-HIVADV014-00|
16343023|NCT00321048|Device|Active Breathing Coordinator|A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
16343024|NCT00321035|Device|OculusGen Biodegradable Collagen Matrix Implant|
16343025|NCT00321022|Behavioral|Accelerated Diagnostic Protocol Emergency Department Observational Unit|
16343026|NCT00321009|Drug|Enoxaparin|
16343027|NCT00320983|Drug|Topotecan|Topotecan
16343028|NCT00320983|Drug|Cisplatin|Cisplatin
16343029|NCT00320970|Drug|Candesartan|
16343030|NCT00320957|Device|OculusGen Biodegradable Collagen Matrix Implant|
16343031|NCT00320931|Device|Hybrid PET/CT|Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.
16343032|NCT00320905|Behavioral|Observational|No intervention
16343033|NCT00320892|Drug|Atropine Sulphate 1% ophthalmic drops|Atropine Sulphate 1% ophthalmic drops will be used, by Fisher Pharmaceutical Labs, at a dose of 2 drops per administration
16343034|NCT00320879|Drug|irbesartan|
16343035|NCT00320866|Device|syringe driver|
16343036|NCT00320853|Drug|Vitamin D|
16343037|NCT00320827|Drug|CS-1008 (humanized anti-DR5 antibody)|
16343038|NCT00320814|Drug|VEGF Trap-Eye|single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
16343039|NCT00320801|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
16343040|NCT00320801|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
16343041|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
16343042|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
16343043|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
16343044|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
16343045|NCT00320788|Biological|aflibercept injection (VEGF Trap-Eye, BAY86-5321)|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
16343046|NCT00320775|Drug|VEGF Trap|"Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye.
~Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later.
~Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap.
~After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap."
16343047|NCT00320762|Device|OculusGen Biodegradable Collagen Matrix Implant|
16343048|NCT00320749|Drug|Capecitabine|Will be give on days 8-21
16343049|NCT00320749|Drug|Docetaxel|Will be given on days 1 and 8,
16343050|NCT00320749|Drug|Gemcitabine|A fixed dose rate will be give on days 8 and 15.
16343051|NCT00320736|Drug|galantamine|
16343052|NCT00320723|Drug|bupropion, transdermal nicotine patch|
16343053|NCT00320710|Drug|Zoledronic acid|4mg IV
16343054|NCT00320710|Drug|Placebo|Placebo to zoledronic acid
16343055|NCT00320697|Drug|bupropion + nicotine patch + nicotine gum or lozenges|Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
16343056|NCT00320697|Drug|Placebo pill + placebo patch|Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
16343057|NCT00320671|Drug|Aripiprazole|The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
16343058|NCT00320671|Drug|Risperidone|The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
16343059|NCT00320658|Biological|MSP1 42-C1/Alhydrogel|Recombinant MSP1 42-C1/Alhydrogel vaccine (one of two doses)
16343060|NCT00320658|Biological|CPG 7909|Adjuvant
16343061|NCT00320632|Drug|Desipramine|
16343062|NCT00320619|Drug|Epsilon-Aminocaproic Acid (EACA)|Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
16343063|NCT00320619|Drug|Placebo|Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
16343064|NCT00320606|Drug|Immunosuppression Withdrawal|Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.
16343065|NCT00320593|Device|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
16343066|NCT00320593|Device|Single Vision Lenses (SVLs)|Single vision lenses
16343067|NCT00320580|Drug|norelgestromin/ethinyl estradiol|
16343068|NCT00320567|Drug|norgestimate/ethinyl estradiol|
16343069|NCT00320554|Behavioral|Durometer analysis|
16343070|NCT00320541|Drug|gemcitabine|1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
16343071|NCT00320541|Drug|paclitaxel|90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
16343072|NCT00320541|Drug|bevacizumab|10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
16343073|NCT00320528|Drug|atomoxetine|0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
16343074|NCT00320515|Drug|pemetrexed|"Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression
~Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression"
16343075|NCT00320515|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days, until disease progression
16343076|NCT00320502|Drug|BXT-51072|
16343077|NCT00320489|Drug|olanzapine|10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
16343078|NCT00320489|Drug|olanzapine pamoate depot|405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
16343079|NCT00320476|Drug|Velcade|
16343080|NCT00320463|Biological|DTPa-HBV-IPV/Hib vaccine|
16343081|NCT00320450|Drug|SB-681323|
16343082|NCT00320424|Drug|Fondaparinux|
16343083|NCT00320411|Drug|lapatinib|Lapatinib 1500mg QD
16343084|NCT00320398|Drug|Fondaparinux|
16343085|NCT00320385|Drug|Lapatinib|oral lapatinib once daily
16343086|NCT00320385|Biological|Trastuzumab|IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose
16343087|NCT00320359|Drug|Intravenous topotecan/cisplatin|"Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5.
~Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan."
16343088|NCT00320359|Drug|Intravenous etoposide/cisplatin|"Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid.
~Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3."
16343089|NCT00320346|Biological|Pandemic Influenza Vaccine|
16343090|NCT00320333|Procedure|pulmonary rehabilitation programme|
16343091|NCT00320320|Drug|Irinotecan|
16343092|NCT00320307|Drug|abacavir|
16343093|NCT00320294|Drug|irinotecan|
16343094|NCT00320294|Drug|cisplatin|
16343095|NCT00320281|Drug|botulinum toxin A|Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.
16343096|NCT00320281|Other|placebo|Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.
16343097|NCT00320268|Drug|Quetiapine fumarate|
16343098|NCT00320255|Drug|Apixaban|Oral tablets administered once daily in 5-, 10-, or 20-mg dose
16343099|NCT00320255|Drug|Placebo|Oral tablets administered once daily
16343100|NCT00320242|Device|1 mo baseline before visual cue|Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
16343101|NCT00320229|Drug|abciximab|
16343102|NCT00320216|Drug|Ustekinumab|Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
16343103|NCT00320216|Drug|Placebo|Patients in the placebo group will receive placebo medication.
16343104|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 6 mg/mL|Single injection, anterior juxtascleral depot (AJD)
16343105|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|Single injection, anterior juxtascleral depot (AJD)
16343106|NCT00320203|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|Single injection, anterior juxtascleral depot (AJD)
16343216|NCT00319202|Drug|Candesartan|32 mg/d for 6 months
16343107|NCT00320203|Other|Anecortave Acetate Vehicle|Single injection, anterior juxtascleral depot (AJD)
16343108|NCT00320190|Drug|Imatinib|Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water.
16343109|NCT00320190|Drug|Dasatinib|Dasatinib tablets administered orally at a dose of 100 mg once daily.
16343110|NCT00320138|Procedure|Acupuncture, using Chinese Medicine methodology|4 weeks of 2/week treatments (8 total); 4 standardized and 4 individualized treatments
16343111|NCT00320125|Dietary Supplement|Orange juice plus calcium|> 1,200mg Ca (four glasses of orange juice plus calcium)per day
16343112|NCT00320125|Dietary Supplement|Dairy products|> 1,200mg Ca (by consuming milk, yogurt, and cheese)
16343113|NCT00320112|Behavioral|Reciprocal Diabetes Peer Support Program|participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact.
16343114|NCT00320112|Behavioral|Nurse Case management|patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly.
16343115|NCT00320112|Behavioral|group outpatient counseling visits|Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6
16343116|NCT00320099|Drug|recombinant human insulin|intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l
16343117|NCT00320099|Drug|hydrocortisone|50 mg as iv bolus every 6 hours for 7 days
16343118|NCT00320099|Drug|fludrocortisone|50 µg once a day via a nasogastric tube for seven days
16343119|NCT00320099|Drug|Hydrocortisone|hydrocortisone 50mg q6 for 7 days
16343120|NCT00320073|Drug|erlotinib hydrochloride|75 mg to 150mg
16343121|NCT00320073|Drug|pemetrexed disodium|Pemetrexed is administered intravenously over 10 minutes, every 21 days
16343122|NCT00320073|Drug|vinflunine|Vinflunine is administered intravenously over 20 minutes and should be given after pemetrexed, every 21 days
16343123|NCT00320060|Drug|Pyridorin (pyridoxamine dihydrochloride)|
16343124|NCT00320047|Drug|Baclofen|Participants will take baclofen 3 times a day, before meals, for 10 weeks. Baclofen dosages will be low to begin, followed by a gradual increase over a 2-week period. Upon reaching the maximum tolerated dose of baclofen, participants will continue at this dosage level until Week 11, at which time the dose will be gradually decreased. If any serious side effects occur, baclofen dosage will be decreased to the previous tolerated dosage level.
16343125|NCT00320034|Drug|R-albuterol, S-albuterol|
16343126|NCT00320021|Drug|Pyridorin (pyridoxamine dihydrochloride)|
16343127|NCT00320008|Behavioral|Diet|
16343128|NCT00320008|Behavioral|Exercise|
16343129|NCT00320008|Behavioral|Stop smoking|
16343130|NCT00320008|Drug|Glucose lowering therapy|
16343131|NCT00320008|Drug|Blood pressure lowering therapy|
16343132|NCT00320008|Drug|Lipid lowering therapy|
16343133|NCT00319995|Drug|loratadine; montelukast|
16343134|NCT00319982|Drug|Diltiazem|Sustained release formulation titrated to a target dose of 360 mg daily, or a maximum of 5 mg/kg/day in pediatric subjects for the duration of the study period
16343135|NCT00319982|Drug|Placebo|Placebo comparator (double-blind allocation of study medication)
16343136|NCT00319969|Drug|Amrubicin|Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
16343137|NCT00319969|Drug|Topotecan|Topotecan 1.5mg/m<2> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
16343138|NCT00319956|Drug|Azithromycin|Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
16343139|NCT00319956|Drug|Placebo|vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
16343140|NCT00319943|Procedure|Computer-based training for Mild Cognitive Impairment (MCI)|
16343141|NCT00319930|Drug|CNF1010 (17-AAG)|
16343142|NCT00319917|Drug|tacrolimus|oral
16343143|NCT00319917|Drug|placebo|oral
16343144|NCT00319891|Procedure|Computer-based Cognitive Training|
16343145|NCT00319878|Drug|Sirolimus|"Oral loading dose followed by a once daily dose:
~Cohort 1: Loading Dose - 1.2 mg; Daily Dose - 0.4 mg
~Cohort 2: % Dose Increase - 100%; Loading Dose - 2.4 mg; Daily Dose - 0.8 mg
~Cohort 3: % Dose Increase - 67%; Loading Dose - 3.9 mg; Daily Dose - 1.3 mg
~Cohort 4: % Dose Increase - 50%; Loading Dose - 6.0 mg; Daily Dose - 2.0 mg"
16343146|NCT00319878|Drug|Cyclosporine|Dose of 5 mg/kg divided as a twice daily oral dose
16343147|NCT00319865|Drug|Velcade|
16343148|NCT00319865|Drug|Thalidomide|
16343149|NCT00319865|Drug|Adriamycin|
16343150|NCT00319865|Drug|Dexamethasone|
16343151|NCT00319852|Biological|DTaP-IPV combined vaccine|0.5 mL, IM
16343152|NCT00319852|Biological|DTaP vaccine|0.5 mL, IM
16343153|NCT00319839|Drug|Abraxane|260 mg/m2 IV over 30 minutes every 3 weeks
16343154|NCT00319839|Drug|Cetuximab|Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles
16343155|NCT00319826|Other|No intervention|This is an observational study with no intervention
16343156|NCT00319813|Behavioral|Education|
16343157|NCT00319800|Drug|Gefitinib|
16343158|NCT00319800|Drug|Irinotecan|
16343159|NCT00319787|Drug|Iressa|
16343160|NCT00319774|Device|Hemocontrol Biofeedback System|
16343161|NCT00319761|Drug|Calcitriol|
16343162|NCT00319748|Drug|852A|0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
16343163|NCT00319735|Procedure|Radiation Therapy|External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
16343164|NCT00319735|Procedure|Surgery|Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
16343165|NCT00319735|Procedure|Tissue Sample|For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
16343166|NCT00319709|Drug|SR58611A|
16343167|NCT00319696|Drug|Bosentan 62.5 mg|Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)
16343168|NCT00319696|Drug|Bosentan 125 mg|Bosentan 125-mg oral tablets administered b.i.d. (target dose)
16343169|NCT00319683|Drug|ADH300004|
16343170|NCT00319670|Drug|MiraLax|
16343171|NCT00319657|Biological|Hematopoietic cell transplantation|Transplantation of hematopoietic stem cells from the living donor.
16343172|NCT00319657|Radiation|Total lymphoid irradiation|Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.
16343173|NCT00319644|Device|Bronchoalveolar lavage|Using catheter to obtain respiratory sample
16343174|NCT00319618|Drug|Gefitinib|
16343175|NCT00319618|Drug|Docetaxel|
16343176|NCT00319605|Drug|Levetiracetam|
16343177|NCT00319592|Biological|ChimeriVax™-JE vaccine|0.5 mL, subcutaneously
16343178|NCT00319592|Biological|JE-VAX® vaccine|1.0 mL, subcutaneously
16343179|NCT00319566|Drug|Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily|
16343180|NCT00319553|Biological|ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
16343181|NCT00319553|Biological|BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed|0.5 mL, IM
16343182|NCT00319540|Behavioral|Control with depression course (CWD)|
16343183|NCT00319514|Drug|Docetaxel|
16343184|NCT00319501|Drug|Placebo|Intramuscular autoinjector; administered at onset of an episode
16343185|NCT00319501|Drug|Vanquix Auto-Injector (Diazepam Injection)|Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
16343186|NCT00319488|Drug|Inhaled Corticosteroid (Budesonide)|Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.
16343187|NCT00319488|Drug|Leukotriene Receptor Antagonist (Montelukast Sodium)|Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.
16343188|NCT00319488|Drug|Inhaled Albuterol|All participants will receive inhaled albuterol treatments four times a day.
16343189|NCT00319475|Procedure|AAA or AF/IB (end-to-end) in patients with Leriche Syndrome|
16343190|NCT00319462|Device|hemoclip|
16343191|NCT00319449|Drug|Ezetimibe|10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin
16343192|NCT00319449|Drug|Placebo|10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin
16343193|NCT00319449|Drug|Atorvastatin 10 mg|10 mg/day atorvastatin, orally, (ongoing treatment in participants)
16343194|NCT00319436|Behavioral|Mentalizing Therapy for Substance Using Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
16343195|NCT00319436|Behavioral|Standard Parent Education for Substance Using Mothers|This 12 session comparison was designed to match the experimental intervention on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
16343196|NCT00319423|Procedure|Patient education and supervised exercise|Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks
16343197|NCT00319410|Procedure|vaginoscopic hysteroscopy|
16343198|NCT00319397|Behavioral|Exercise-Training Program|
16343199|NCT00319384|Device|Ultrafiltration therapy|
16343200|NCT00319358|Dietary Supplement|Antioxidants|600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months
16343201|NCT00319358|Dietary Supplement|Placebo|placebo
16343202|NCT00319345|Drug|Mannitol, Sodium-Lactate|
16343203|NCT00319332|Drug|Ibritumomab Tiuxetan|
16343204|NCT00319332|Drug|Iodine I 131 Tositumomab|
16343205|NCT00319319|Drug|Mecamylamine hydrochloride (Inversine)|
16343206|NCT00319306|Drug|Budesonide/formoterol|
16343207|NCT00319306|Device|Symbicort® Turbohaler®|
16343208|NCT00319293|Drug|Metformin|
16343209|NCT00319280|Procedure|bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)|Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control
16343210|NCT00319267|Drug|Bosentan|Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets
16343211|NCT00319254|Drug|SKI-606 (Bosutinib)|SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
16343212|NCT00319241|Behavioral|Parenting Intervention|
16343213|NCT00319228|Drug|Plasma-derived AT-III concentrate|"Segment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI will be administered to each patient.
~Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan."
16343214|NCT00319215|Drug|Ramelteon 8 mg|
16343217|NCT00319202|Drug|Placebo|Placebo administration for 6 months
16343218|NCT00319189|Drug|Nateglinide|
16343219|NCT00319163|Drug|levonorgestrel/ethinyl estradiol|
16343220|NCT00319150|Drug|erythropoietin|Decrease dosage by 12.5% q 2 weeks according to an algorithm.
16343221|NCT00319137|Drug|GW274150|
16343222|NCT00319111|Drug|bosentan|"Oral bosentan
~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
16343223|NCT00319098|Biological|Adjuvanted pandemic influenza candidate vaccine|2 doses, intramuscular injection
16343224|NCT00319098|Biological|Fluarix|One intramuscular injection
16343225|NCT00319098|Biological|Placebo|One intramuscular injection
16343226|NCT00319085|Procedure|Total hip replacement (Preheating of femur stem)|Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
16343227|NCT00319072|Behavioral|TalkToYourDoc(sm) hormone therapy module|
16343228|NCT00319059|Drug|systemic administration of 99mTc-HYNIC-Annexin A5|
16343229|NCT00319059|Behavioral|10 minutes of ischemic handgripping|
16343230|NCT00319046|Drug|Miglustat|Oral capsules containing miglustat 100 mg, administered three times daily (t.i.d.)
16343231|NCT00319033|Drug|bosentan|
16343232|NCT00319020|Drug|Bosentan|32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally
16343233|NCT00319007|Drug|Sulindac (drug)|
16343234|NCT00319007|Drug|VSL#3 (probiotic)|
16343235|NCT00319007|Drug|Inulin (probiotic)|
16343236|NCT00318994|Drug|Meropenem|
16343237|NCT00318981|Drug|Concerta|
16343238|NCT00318968|Drug|Esomeprazole|
16343239|NCT00318955|Drug|Dexmedetomidine|
16343240|NCT00318955|Drug|Propofol|
16343241|NCT00318942|Drug|Crystalloids|Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stay
16343242|NCT00318942|Drug|Colloids|Gelatines, Albumine, Starch, or any other colloids, at the necessary dose to restore hemodynamic (starch cumulative daily dose should not exceed 35/40 ml/kg), for all ICU stay
16343243|NCT00318942|Drug|Crystalloids|Any crystalloids given for correction of hypovolemia during all ICU stay
16343244|NCT00318942|Drug|Colloids|Any colloids given for correction of hypovolemia during all ICU stay
16343245|NCT00318929|Drug|Divalproex Sodium Extended-Release Tablets|Once a day dosing
16343246|NCT00318903|Drug|Irinotecan (drug)|50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
16343247|NCT00318903|Drug|Taxotere (drug)|Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
16343248|NCT00318903|Procedure|Radiotherapy (procedure)|Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.
16343249|NCT00318903|Procedure|Esophagectomy (procedure)|After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
16343250|NCT00318890|Drug|Cisplatin|Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
16343251|NCT00318890|Drug|Docetaxel|Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.
16343252|NCT00318890|Procedure|Radiotherapy|Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.
16343253|NCT00318890|Drug|Amifostine|Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
16343254|NCT00318877|Behavioral|After school team sports program|
16343255|NCT00318877|Behavioral|After school health education program|
16343256|NCT00318864|Behavioral|Cognitive behavioral therapy|
16343257|NCT00318851|Device|Carotid Stent with Distal Protection Device|Carotid Stent Placement with Distal Protection
16343258|NCT00318838|Drug|Azimilide dihydrochloride|125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
16343259|NCT00318838|Drug|Placebo|Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
16343260|NCT00318825|Drug|Nitrous oxide|
16343261|NCT00318812|Drug|Heme Iron Polypeptide (Proferrin)|Heme iron polypeptide 11mg po tid for 6 months
16343262|NCT00318812|Drug|Iron sucrose (Venofer)|Iron sucrose infusion IV q month x 6 months
16343263|NCT00318799|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658ID)|per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
16343264|NCT00318799|Drug|SH D01155E|per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo
16343265|NCT00318786|Drug|biphasic insulin aspart|
16343266|NCT00318773|Drug|sertraline|50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.
16343267|NCT00318760|Drug|Clonidine|0.1 or 0.2 mg oral, one dose
16343268|NCT00318760|Drug|Placebo|oral capsule 1 dose
16343269|NCT00318747|Drug|Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)|
16343270|NCT00318721|Device|Long Lasting Impregnated Nets (LLIN)|Distribution of LLIN in selected clusters
16343271|NCT00318708|Drug|clarithromycin|clarithromycin 500 mg twice daily (Biaxin)
16343272|NCT00318708|Drug|fluticasone propionate|fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
16343273|NCT00318708|Drug|placebo clarithromycin|placebo clarithromycin twice daily
16343274|NCT00318695|Dietary Supplement|Probiotics|Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
16343275|NCT00318695|Other|Placebo|Commercially available cow's milk based infant formula without probiotic supplementation
16355693|NCT00217438|Drug|melphalan|Given IV
16343276|NCT00318682|Device|FIBROSCAN|diagnostic examination of the hepato fibrosis
16343277|NCT00318669|Drug|Paroxetine hydrochloride hydrate|
16343278|NCT00318656|Drug|rosiglitazone-metformin fixed dose combination|
16343279|NCT00318656|Drug|metformin + glimepiride|
16343282|NCT00318630|Drug|Rosiglitazone|Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.
16343283|NCT00318630|Drug|Placebo|Subjects will also receive placebo oral tablet.
16343284|NCT00318617|Drug|GW510516X|
16343285|NCT00318591|Device|SpeediCath|hydrophilic coated urinary intermittent catheter
16343286|NCT00318591|Device|Conveen Uncoated|Uncoated urinary intermittent catheter
16343287|NCT00318565|Device|RF energy delivery for treatment of Typical Atrial flutter|Navistar ThermoCool catheter
16343288|NCT00318552|Drug|Meropenem|
16343289|NCT00318539|Drug|Quetiapine|
16343290|NCT00318513|Drug|Bevacizumab|
16343291|NCT00318500|Drug|ERB-041|
16343292|NCT00318487|Procedure|Bilateral sinus augmentation with immediately loaded dental implants|Bilateral sinus augmentation with immediately loaded dental implants will be used.
16343293|NCT00318474|Drug|Mycophenolate Mofetil (MMF)|Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
16343294|NCT00318474|Drug|MMF Placebo|Placebo only, oral administration
16343295|NCT00318474|Drug|ACEi|Administer same as pre-treatment regimen.
16343296|NCT00318474|Drug|FOS|Administer same as pre-treatment regimen
16343297|NCT00318461|Drug|liraglutide|0.6 mg for s.c. (under the skin) injection.
16343298|NCT00318461|Drug|metformin|1.5-2.0 g tablets
16343299|NCT00318461|Drug|glimepiride|4 mg tablets
16343300|NCT00318461|Drug|placebo|Glimepiride placebo 1 mg and 2 mg tablets
16343301|NCT00318461|Drug|placebo|Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
16343302|NCT00318461|Drug|liraglutide|1.2 mg for s.c. (under the skin) injection
16343303|NCT00318461|Drug|liraglutide|1.8 mg for s.c. (under the skin) injection
16343304|NCT00318448|Drug|Zolpidem (SL800750)|
16343305|NCT00318435|Device|Stent or stent-graft deployment|
16343306|NCT00318422|Drug|liraglutide|
16343307|NCT00318422|Drug|rosiglitazone|
16343308|NCT00318422|Drug|glimepiride|
16343309|NCT00318409|Drug|Bupropion|
16343310|NCT00318409|Drug|Placebo|
16343311|NCT00318396|Procedure|Bone preparation technique: compaction|The bone is pressed very hard together before implantation of femoral component.
16343312|NCT00318396|Procedure|Bone preparation technique: conventional technique|Bone is broached before implantation of femoral component.
16343313|NCT00318383|Biological|NicVAX conjugate vaccine|200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
16343314|NCT00318383|Biological|Placebo|Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months
16343315|NCT00318370|Drug|Farletuzumab|Weekly Farletuzumab infusions Dose dependent on dosing group
16343316|NCT00318370|Drug|Chemo Plus Far|Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
16343317|NCT00318357|Device|Continuation of CRT|Implantation of CRT device and medical treatment according normal hospital routine.
16343318|NCT00318357|Device|Upgrade to CRT|Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
16343319|NCT00318344|Drug|Atuna Racemosa|
16343320|NCT00318331|Drug|Glutamine|Group A patients will receive 0.5g/kg/day of enteral glutamine daily while they are receiving tube feeds or at the end of 28 days (whichever comes first)
16343321|NCT00318318|Drug|Premarin|
16343322|NCT00318292|Drug|bupivacaine and epinephrine|20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
16343323|NCT00318292|Drug|Placebo|20 ml normal saline injection.
16343324|NCT00318279|Device|Surgical simulator to practice vascular anastomosis|
16343325|NCT00318266|Device|Nuclear Matrix Protein 22 Urine sample kit|Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.
16343326|NCT00318253|Procedure|cranberry juice|
16343327|NCT00318240|Device|High Intensity Focused Ultrasound|Treatment of Radiation failure in Prostate Cancer
16343328|NCT00318227|Procedure|Blood Transfusion|Blood transfusion will be administered when the transfusion trigger is met.
16343329|NCT00318214|Drug|MRE0094|Gel, 500 mcg/g once each day
16343330|NCT00318214|Drug|Vehicle gel|Gel administered once per day
16343331|NCT00318201|Drug|Erythromycin|
16343332|NCT00318201|Drug|Diltiazem|
16343333|NCT00318188|Procedure|standardized reeducation and readaptation program|
16343334|NCT00318175|Drug|Bosentan (Tracleer)|
16343335|NCT00318162|Drug|low dose naltrexone|
16343336|NCT00318149|Biological|Fluarix|1 dose administered intramuscularly in the deltoid region of the non-dominant arm
16343337|NCT00318149|Biological|Fluarix-AS25|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
16343338|NCT00318149|Biological|Fluarix-AS50|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
16343339|NCT00318149|Biological|Fluarix-AS01B|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
16343340|NCT00318149|Biological|Fluarix-AS01E|1 dose administered intramuscularly into the deltoid region of the non-dominant arm
16343341|NCT00318136|Drug|Bevacizumab|15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
16343342|NCT00318136|Drug|Carboplatin|Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
16343343|NCT00318136|Drug|Paclitaxel|Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
16343540|NCT00316849|Procedure|adjuvant therapy|
16343344|NCT00318123|Drug|Kivexa|abacavir 600mg + lamivudine 300mg in one tablet QD
16343345|NCT00318110|Procedure|NST using MUD for metastatic renal cell carcinoma|"Preparative regimen:
~Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11"
16343346|NCT00318084|Drug|Esomeprazole|
16343347|NCT00318084|Procedure|Ambulatory 24-hour esophageal pH-monitoring|
16343348|NCT00318071|Device|Merci Retriever|"For patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers.
~Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries.
~Recanalization was defined as TIMI II or TIMI III per angiography."
16343349|NCT00318058|Biological|influenza vaccine Fluarix, Adjuvanted Fluarix|
16343350|NCT00318045|Device|Eyeglass lenses|
16343351|NCT00318032|Drug|multi-factorial intervention|
16343352|NCT00318019|Dietary Supplement|OPC Factor(TM)|Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
16343353|NCT00318019|Other|Placebo|Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
16343354|NCT00318006|Procedure|saline irrigation|subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
16343355|NCT00318006|Procedure|saline spray|subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
16343356|NCT00317993|Drug|ezetimibe|
16343357|NCT00317993|Drug|simvastatin|
16343358|NCT00317993|Drug|ezetimibe plus simvastatin|
16343359|NCT00317980|Drug|Meglumine antimoniate|Meglumine antimoniate 5mg/kg/d for 20 days
16343360|NCT00317980|Drug|Meglumine antimoniate|Meglumine antimoniate 15 mg/kg/d for 20 days
16343361|NCT00317967|Drug|Atorvastatin|80 mg pills daily
16343362|NCT00317967|Drug|Placebo|80 mg pills daily
16343363|NCT00317954|Drug|Spironolactone|
16343364|NCT00317941|Drug|Betaferon/Betaseron|250ug administrated with Betaject
16343365|NCT00317941|Drug|Rebif|44ug administered with Rebiject II
16343366|NCT00317941|Drug|Betaferon/Betaseron|250ug administrated with Betaject light
16343367|NCT00317928|Drug|Metformin|
16343368|NCT00317915|Drug|Irbesartan treatment|
16343369|NCT00317902|Drug|Epoetin alfa|
16343370|NCT00317889|Procedure|Bone preparation technique: compaction|
16343371|NCT00317889|Procedure|Bone preparation technique: broaching|
16343372|NCT00317876|Drug|cyclophosphamide|
16343373|NCT00317876|Drug|cyclosporine|
16343374|NCT00317876|Drug|methotrexate|
16343375|NCT00317876|Procedure|allogeneic bone marrow transplantation|
16343376|NCT00317876|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16343377|NCT00317850|Drug|Gabapentin (Neurontin)|
16343378|NCT00317837|Procedure|Unipolar Hemiarthroplasty of the hip joint|Unipolar Hemiarthroplasty of the hip joint
16343379|NCT00317837|Procedure|bipolar hemiarthroplasty|bipolar hemiarthroplasty
16343380|NCT00317811|Dietary Supplement|ascorbic acid|
16343381|NCT00317811|Drug|bortezomib|
16343382|NCT00317811|Drug|melphalan|
16343383|NCT00317798|Biological|anti-thymocyte globulin|Escalating doses of rATG,intravenously, starting at 6 mg/kg to a maximum of 14.5 mg/kg. Rapamycin is given orally, starting at a dose of 1 mg daily beginning on day 1 and terminating on day 30. The dose of rapamycin was adjusted to maintain a constant blood level of 4-6 ng/ml in all subjects
16343384|NCT00317798|Drug|sirolimus|escalating doses of rATG, intravenously, starting at 6 mg/kg to a maximum of 14.5 mg/kg. Rapamycin is given orally, starting at a dose of 1 mg daily beginning on day 1 and terminating on day 30. The dose of rapamycin was adjusted to maintain a constant blood level of 4-6 ng/ml in all subjects
16343385|NCT00317785|Drug|cyclophosphamide|
16343386|NCT00317785|Drug|cyclosporine|
16343387|NCT00317785|Drug|methotrexate|
16343388|NCT00317785|Drug|mycophenolate mofetil|
16343389|NCT00317785|Drug|sirolimus|
16343390|NCT00317785|Drug|tacrolimus|
16343391|NCT00317785|Other|pharmacological study|
16343392|NCT00317785|Procedure|allogeneic bone marrow transplantation|
16343393|NCT00317785|Procedure|allogeneic hematopoietic stem cell transplantation|
16343394|NCT00317785|Procedure|peripheral blood stem cell transplantation|
16343395|NCT00317785|Radiation|total-body irradiation|
16343396|NCT00317772|Drug|Topotecan|"Phase I Starting Dose: 2 mg/m^2 by vein Weekly Over 30 Minutes on Days 1, 8, and 15.
~Phase II: MTD dose from Phase I by vein weekly on Days 1, 8, and 15."
16343397|NCT00317772|Drug|Gefitinib|"Phase I: 250 mg by mouth daily for 28 Days.
~Phase II: 250 mg by mouth daily for 28 Days."
16343398|NCT00317759|Biological|therapeutic autologous lymphocytes|
16343399|NCT00317759|Drug|fludarabine phosphate|
16343400|NCT00317746|Drug|Citalopram|
16343401|NCT00317746|Drug|Placebos|
16343402|NCT00317733|Drug|Ketoprofen in Transfersome|
16343403|NCT00317720|Drug|Trastuzumab|"Loading dose = 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle.
~If participant on trastuzumab at time of registration, loading dose deferred and received maintenance dose (6 mg/kg every 3 weeks). If the last trastuzumab dose was given 1 week (for participants receiving 2 mg/kg/week), or 3 weeks before registration (for participants receiving 6 mg/kg every 3 weeks), a loading dose (8 mg/kg) was given followed by maintenance dose."
16343404|NCT00317720|Drug|RAD001|Starting dose 10 mg by mouth daily. Phase I dose finding from two dose levels of daily RAD001 (5 and 10 mg).
16356285|NCT00211653|Drug|N-Acetylcysteine|
16343405|NCT00317707|Drug|N-3 Polyunsaturated Fatty Acids|Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
16343406|NCT00317707|Drug|Placebo: Olive oil|Each subject assigned to the control group will receive 1 g/day capsule of olive oil.
16343407|NCT00317694|Drug|Fermagate|Film coated tablet 500mg
16343408|NCT00317694|Drug|Placebo|Oral administration, film coated tablet, 0mg
16343409|NCT00317681|Drug|Tacrolimus ointment|
16343410|NCT00317655|Drug|Glucosamine sulphate|
16343411|NCT00317655|Drug|Ginger|
16343412|NCT00317655|Drug|Ginger-Avocado-Soya|
16343413|NCT00317655|Drug|Ginger-ibuprofen|
16343414|NCT00317642|Drug|clofarabine (IV formulation)|clofarabine (IV formulation) infusion 40mg/m^2 / day up to 3 cycles
16343415|NCT00317642|Drug|placebo|placebo (sodium Chloride) 1-hour IV infusion
16343416|NCT00317642|Drug|cytarabine|cytarabine IV infusion 1g/m^2/day for up to 3 cycles
16343417|NCT00317629|Drug|controlled nitric oxide releasing patch|daily nitric oxide patch application during 20 days
16343418|NCT00317629|Drug|meglumine antimoniate|20mg/kg daily during 20 days
16343419|NCT00317603|Biological|Autologous, Lethally Irradiated Breast Cancer Cells|Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
16343420|NCT00317590|Device|Rapid Diagnostic Test for Malaria (Paracheck®)|
16343421|NCT00317577|Drug|brimonidine, timolol|
16343422|NCT00317551|Device|Aberration controlled contact lens|
16343423|NCT00317551|Behavioral|Vision training|
16343424|NCT00317538|Drug|infliximab, etanercept|
16343425|NCT00317525|Device|Spectacle Lenses|
16343426|NCT00317512|Procedure|Percutaneous Coronary Revascularization|
16343427|NCT00317512|Drug|Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)|
16343428|NCT00317512|Drug|Voluven|
16343429|NCT00317499|Other|Placebo|Placebo
16343430|NCT00317499|Drug|Etanercept|Etanercept
16343431|NCT00317486|Drug|bosentan|
16343432|NCT00317473|Biological|FMP1/AS02A Malaria vaccine|Subjects vaccinated with FMP1/AS02 vaccine
16343433|NCT00317473|Biological|Imovax Rabies vaccine|Subjects vaccinated on corresponding FMP1/AS02A vaccination days
16343434|NCT00317460|Other|Physician Management|Standard physician care
16343435|NCT00317460|Behavioral|Counseling|Physician Management and Counseling
16343436|NCT00317447|Drug|Oral Prednisone|
16343437|NCT00317434|Drug|lapatinib|
16343438|NCT00317421|Drug|Sildenafil citrate|
16343439|NCT00317408|Biological|anti-thymocyte globulin|
16343440|NCT00317408|Drug|busulfan|
16343441|NCT00317408|Drug|carboplatin|
16343442|NCT00317408|Drug|carmustine|
16343443|NCT00317408|Drug|cyclosporine|
16343444|NCT00317408|Drug|cytarabine|
16343445|NCT00317408|Drug|dexamethasone|
16343446|NCT00317408|Drug|etoposide phosphate|
16343447|NCT00317408|Drug|idarubicin|
16343448|NCT00317408|Drug|ifosfamide|
16343449|NCT00317408|Drug|leucovorin calcium|
16343450|NCT00317408|Drug|lomustine|
16343451|NCT00317408|Drug|melphalan|
16343452|NCT00317408|Drug|methotrexate|
16343453|NCT00317408|Drug|mitoxantrone hydrochloride|
16343454|NCT00317408|Drug|prednisolone|
16343455|NCT00317408|Drug|thiotepa|
16343456|NCT00317408|Drug|vinblastine sulfate|
16343457|NCT00317408|Drug|vindesine|
16343458|NCT00317408|Procedure|allogeneic hematopoietic stem cell transplantation|
16343459|NCT00317408|Procedure|autologous hematopoietic stem cell transplantation|
16343460|NCT00317408|Procedure|peripheral blood stem cell transplantation|
16343461|NCT00317408|Radiation|total-body irradiation|
16343462|NCT00317395|Drug|Otamixaban (XRP0673)|intravenous administration
16343463|NCT00317395|Drug|unfractionated heparin|intravenous administration
16343464|NCT00317395|Drug|eptifibatide|intravenous administration
16343465|NCT00317382|Device|Ultrasound|Ultrasound used to visualize spine to determine best location for lumbar puncture.
16343466|NCT00317369|Drug|OPC-6535(Tetomilast)|
16343467|NCT00317356|Drug|OPC-6535(Tetomilast)|
16343468|NCT00317343|Drug|Bivalirudin (thrombin specific anticoagulant)|Percutaneous Coronary Intervention
16343469|NCT00317330|Drug|Isoniazid|
16343470|NCT00317330|Drug|Pyrazinamide|
16343471|NCT00317330|Drug|Rifampin|
16343472|NCT00317317|Procedure|Acupuncture|4 acupuncture treatments will be conducted during the IVF cycle. The 1st one is at the beginning of egg stimulation, the 2nd one is before the egg retrieval, the 3rd and 4th one are before and after the embryo transfer
16343473|NCT00317304|Behavioral|Mindfulness-based stress reduction|MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
16343474|NCT00317291|Procedure|Acupuncture/Moxibustion|Acupuncture/Moxibustion: 16 scheduled sessions
16343475|NCT00317291|Other|Sham acupuncture/Placebo moxibustion|Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
16343476|NCT00317278|Other|massage therapy|massage therapy to stable preterm infants
16343477|NCT00317278|Other|Sham|Sham (placebo) provided to the control group
16343478|NCT00317265|Procedure|Coronary bypass surgery|
16343479|NCT00317252|Drug|Hold ACEI or ARB|Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-96 hours post-catheterization (after creatinine measurement)
16343480|NCT00317239|Drug|Ferrous Sulfate tablets|325 mg/TID x 8 weeks
16343481|NCT00317239|Drug|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
16343482|NCT00317226|Drug|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
16343483|NCT00317213|Drug|LIBERTAL- a phospholipid mixture|
16343484|NCT00317200|Drug|Paclitaxel|Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
16343485|NCT00317200|Drug|Bevacizumab|Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle
16343486|NCT00317187|Biological|Tritanrix-HepB/Meningitec conjugate vaccine|The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
16343487|NCT00317187|Biological|Tritanrix/Hiberix vaccine|The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
16343488|NCT00317174|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
16343489|NCT00317161|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
16343490|NCT00317148|Drug|Placebos|Placebo capsule
16343491|NCT00317148|Drug|DHEA capsule|One capsule of DHEA
16343492|NCT00317135|Biological|Tritanrix-HepB/Meningitec conjugate vaccine|The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
16343493|NCT00317135|Biological|Tritanrix/Hiberix vaccine|The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
16343494|NCT00317122|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
16343495|NCT00317109|Biological|Tritanrix™- HepB|One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
16343496|NCT00317109|Biological|Hiberix™|One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
16343497|NCT00317109|Biological|Mencevax™ ACW|One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
16343498|NCT00317096|Procedure|FCM|Active comparator: Chemotherapy
16343499|NCT00317096|Procedure|R-FCM|experimental: Chemotherapy with additional rituximab
16343500|NCT00317096|Drug|rituximab maintenance|2 courses of rituximab maintenance after completion of salvage therapy
16343501|NCT00317096|Other|observation only|no Intervention after completion of FCM or R-FCM
16343502|NCT00317083|Procedure|Cough reflex test|
16343503|NCT00317070|Drug|dimethyl sulfoxide|intravesical installation 50 ml
16343504|NCT00317070|Drug|IC Cocktail|"Heparin 10,000 units
~Gentamicin 80 mg
~Hydrocortisone sodium succinate (Solucortef) 100 mg
~Lidocaine hydrochloride 1% 10 ml
~Sodium Bicarbonate 8.4% 5 ml"
16343505|NCT00317057|Procedure|Patient education and disease management|
16343506|NCT00317044|Drug|Esomeprazole|Esomeprazole 40 mg twice daily
16343507|NCT00317044|Drug|Esomeprazole|Esomeprazole 40 mg once daily
16343508|NCT00317044|Drug|Placebo|Placebo twice daily
16343509|NCT00317031|Drug|Acamprosate or Naltrexone|mg&d 90 days
16343510|NCT00317018|Behavioral|Evidence-Based Quality Improvement|The implementation intervention is known as Evidence-Based Quality Improvement (EBQI). EBQI is an adaptation of the Plan-Do-Study-Act cycles of Continuous Quality Improvement that emphasizes empirical evidence and the involvement of clinical and implementation experts (i.e., researchers). In the EBQI implementation intervention, both researchers (clinical and implementation experts) and local staff participate fully in the quality improvement process, with the researchers facilitating rather than dictating implementation efforts. Using EBQI methods, researchers and local staff adapt evidence-based practices for local resources, needs and preferences while maintaining fidelity to the evidence-base. PDSA cycles are used to continuously revise the adapted evidence-based practice based on feedback during pilot tests.
16343511|NCT00317005|Drug|folate treatment|
16343512|NCT00316992|Drug|Ramelteon and Placebo|Ramelteon 8 mg, tablets, orally, one night only and Ramelteon placebo-matching tablets, orally, one night only.
16343513|NCT00316979|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
16343514|NCT00316966|Behavioral|Multidisciplinary dietary intervention|
16343515|NCT00316953|Drug|dasatinib|Given orally
16343516|NCT00316953|Other|pharmacological study|Correlative studies
16343517|NCT00316953|Other|laboratory biomarker analysis|Correlative studies
16343518|NCT00316940|Drug|bortezomib|
16343519|NCT00316940|Radiation|samarium Sm 153 lexidronam pentasodium|
16343520|NCT00316927|Drug|acetylsalicylic acid|
16343521|NCT00316927|Drug|dexamethasone|
16343522|NCT00316927|Drug|diethylstilbestrol|
16343523|NCT00316914|Drug|calcium gluconate|Given IV
16343524|NCT00316914|Drug|magnesium sulfate|Given IV
16343525|NCT00316914|Other|placebo|Given IV
16343526|NCT00316901|Procedure|computed tomography|
16343527|NCT00316901|Procedure|positron emission tomography|
16343528|NCT00316901|Radiation|fludeoxyglucose F 18|
16343529|NCT00316888|Biological|cetuximab|Given IV
16343530|NCT00316888|Drug|cisplatin|Given IV
16343531|NCT00316888|Drug|fluorouracil|Given IV
16343532|NCT00316888|Radiation|radiotherapy|Given once daily 5 days a week for 5 weeks
16343533|NCT00316875|Drug|lapatinib ditosylate|1500 mg orally daily for as long as patients remain on trial (up to 8 cycles).
16343534|NCT00316875|Drug|Doxil|Administered intravenously (IV) every 4 weeks in a dose-escalating fashion according to a set schedule
16343535|NCT00316862|Drug|cisplatin|Given IV
16343536|NCT00316862|Drug|irinotecan hydrochloride|Given IV
16343537|NCT00316862|Procedure|therapeutic conventional surgery|Undergo Surgery
16343538|NCT00316862|Radiation|radiation therapy|Undergo radiation
16343539|NCT00316849|Other|pharmacological study|
16343541|NCT00316849|Radiation|3-dimensional conformal radiation therapy|
16343542|NCT00316849|Radiation|intensity-modulated radiation therapy|
16343543|NCT00316849|Drug|temsirolimus|Given IV
16343544|NCT00316849|Drug|temozolomide|Given orally
16343545|NCT00316836|Procedure|mammography|
16343546|NCT00316823|Genetic|gene expression analysis|
16343547|NCT00316823|Genetic|polymerase chain reaction|
16343548|NCT00316823|Genetic|reverse transcriptase-polymerase chain reaction|
16343549|NCT00316823|Other|diagnostic laboratory biomarker analysis|
16343550|NCT00316823|Other|immunohistochemistry staining method|
16343551|NCT00316823|Procedure|needle biopsy|
16343552|NCT00316810|Drug|Alemtuzumab|Day 0: Campath 30 mg i.v. infusion over 3-6 hours
16343553|NCT00316810|Drug|Rabbit Anti-Human Thymocyte Globulin|Day O: Single shot of a polyclonal antilymphocyte preparation (ATG-Fresenius - 8 mg/kg, or IMTIX-Sangstat ATG 4 mg/kg/day).
16343554|NCT00316797|Drug|123-I INER|Serial whole body planar imaging in the anterior and posterior projection will be performed at 1 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, and 18-24h following injection of 5 mCi of 123-I INER. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection and urine sampled in five collections every 4 hours collection for first sixteen hours (4 collections), then one collection from 16 to 24 h. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs using the MIRD method as described previously (Seibyl, et al, 1993). Plasma and urine metabolites will be characterized and safety assessments obtained.
16343555|NCT00316784|Drug|IDEA-033 (and rescue medication)|
16343556|NCT00316771|Drug|P38 Inhibitor (4) 150mg|150mg po qd
16343557|NCT00316771|Drug|P38 Inhibitor (4) 25mg|25mg po bid
16343558|NCT00316771|Drug|P38 Inhibitor (4) 300mg|300mg po qd
16343559|NCT00316771|Drug|P38 Inhibitor (4) 50mg|50mg po qd
16343560|NCT00316771|Drug|P38 Inhibitor (4) 75mg|75mg po bid
16343561|NCT00316771|Drug|Placebo|po bid
16343562|NCT00316758|Drug|GK Activator (2)|Escalating doses bid
16343563|NCT00316758|Drug|Metformin|As prescribed, in patients who were in study BM18249
16343564|NCT00316745|Drug|Campto, Topotesin|100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
16343565|NCT00316745|Drug|TS-1|S-1 Day1~14, everyday P.O.(Day 15~28 rest)
16343566|NCT00316745|Drug|L-Plat|Oxaliplatin (85mg/m2) Day 1, 15
16343567|NCT00316745|Drug|Isovorin|l-leucovorin (200mg/m2) Day 1, 15
16343568|NCT00316745|Drug|5-FU|400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1~3 (48 hours) of each 28 day cycle.
16343569|NCT00316732|Procedure|IPSS Questionnaire|
16343570|NCT00316732|Procedure|EQ-5D Questionnaire|
16343571|NCT00316719|Drug|LAM group|Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
16343572|NCT00316719|Drug|ADV group|Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
16343573|NCT00316706|Biological|GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)|Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
16343574|NCT00316706|Biological|Havrix™|Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
16343575|NCT00316693|Biological|HPV-16/18 vaccine (Cervarix™)|Intramuscular injection, 3 doses
16343576|NCT00316693|Biological|Aimmugen™|Intramuscular injection, 3 doses
16343577|NCT00316680|Biological|Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine|
16343578|NCT00316654|Biological|Meningococcal C conjugate vaccine|
16343579|NCT00316641|Drug|Lipid-lowing Tea|
16343580|NCT00316628|Biological|influenza vaccine|
16343581|NCT00316615|Biological|influenza vaccine|
16343582|NCT00316602|Biological|IMVAMUNE|Subjects receiving two subcutaneous vaccinations
16343583|NCT00316589|Biological|IMVAMUNE (MVA-BN)|2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
16343584|NCT00316576|Procedure|Blood sampling for PCR|
16343585|NCT00316563|Drug|Marinol (Dronabinol)|Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.
16343586|NCT00316563|Other|Placebo|
16343587|NCT00316550|Drug|AV608|
16343588|NCT00316537|Drug|ATG002 (study drug)|
16343589|NCT00316524|Biological|MVA-BN® (IMVAMUNE)|1x 10E8_TCID50
16343590|NCT00316524|Biological|Placebo|Tris-Buffer
16343591|NCT00316511|Drug|Aroplatin|
16343592|NCT00316498|Drug|OGT918|
16343593|NCT00316472|Drug|Niacinamide|
16343594|NCT00316459|Drug|ERB-041|
16343595|NCT00316433|Drug|Irinotecan (CPT-11)|
16343596|NCT00316433|Drug|Oxaliplatin (Eloxatin)|
16343597|NCT00316420|Drug|Capecitabine (Xeloda)|650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14
16343598|NCT00316420|Drug|Gemcitabine|750 mg/m2 IV Days 1 & 8 q 21 days
16343599|NCT00316407|Drug|lapatinib (GW572016)|1000 mg po qd
16343600|NCT00316407|Drug|Carboplatin|AUC 2 weekly x 3 of 4 week cycle
16343601|NCT00316407|Drug|Paclitaxel|60 mg/m2 weekly x 3 of 4 week cycle
16343602|NCT00316394|Device|Preventive Care Checklist Form|
16343603|NCT00316381|Procedure|Autologous bone marrow-derived stem cells|
16343604|NCT00316368|Device|Ethicon TPW32 60 cm (pacing wires x 2)|
16343605|NCT00316355|Behavioral|Traditional CBT|CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
16343606|NCT00316355|Behavioral|Stepped-Care CBT|In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
16343607|NCT00316342|Device|Back supports|
16343608|NCT00316329|Drug|Artesunate + Amodiaquine|
16343609|NCT00316316|Behavioral|Motivational interviewing plus exposure and response prevention (MI plus EX/RP)|Participants will receive 18 sessions of MI plus EX/RP.
16343610|NCT00316316|Behavioral|Exposure and response prevention (EX/RP)|Participants will receive 18 sessions of EX/RP.
16343611|NCT00316303|Drug|Twinrix|This vaccine will be given in three parts: at entry and after 3 and 6 months.
16343612|NCT00316303|Behavioral|Enhanced treatment as usual|Participants will receive comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
16343613|NCT00316290|Behavioral|Integrated Parent Training|Treatment will include behavioral parent training, a course on coping with depression, and cognitive-behavioral therapy targeted at coping with stressful parenting situations. Treatment will include weekly 2-hour sessions for 14 weeks.
16343614|NCT00316290|Behavioral|Behavioral Parent Training|Parents will receive behavioral training. Treatment will include weekly 2-hour sessions for 14 weeks.
16343615|NCT00316277|Behavioral|Standard Medical Management (SMM) of Prescription Opiate Abuse|Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
16343616|NCT00316277|Behavioral|Enhanced Medical Management (EMM) of Prescription Opiate Abuse|Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
16343617|NCT00316264|Biological|Motavizumab, palivizumab|Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
16343618|NCT00316264|Biological|Palivizumab, motavizumab|Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.
16343619|NCT00316264|Biological|Motavizumab|Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
16343620|NCT00316251|Device|Vibration Plate Therapy|
16343621|NCT00316238|Drug|olanzapine-RAIM|
16343622|NCT00316238|Drug|placebo|
16343623|NCT00316225|Drug|pemetrexed|500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles
16343624|NCT00316212|Drug|INS50589 Intravenous Infusion|
16343625|NCT00316199|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression
16343626|NCT00316199|Drug|paclitaxel|175 mg/m2, intravenous (IV), every 21 days until disease progression
16343627|NCT00316186|Drug|topotecan|Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.
16343628|NCT00316186|Drug|carboplatin|Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.
16343629|NCT00316173|Drug|topotecan|HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
16343630|NCT00316173|Drug|CARBOPLATIN|HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
16343631|NCT00316160|Drug|Bupropion Hydrochloride Extended-release|
16343632|NCT00316160|Drug|Extended-release Venlafaxine|
16343633|NCT00316147|Biological|DTPa-HBV-IPV/Hib vaccine|
16343634|NCT00316134|Procedure|Procedure/Surgery|Diagnostic and/or therapeutic procedure to remove pleural fluid.
16343635|NCT00316121|Device|HEALOS and Leopard Cage|Placement in interbody space
16343636|NCT00316121|Device|Leopard Cage and Autograft|Placement in the interbody space
16343637|NCT00316108|Device|WALLSTENT® Endoprosthesis™|Carotid Artery Stent
16343638|NCT00316095|Drug|telmisartan|
16343639|NCT00316095|Drug|simvastatin|
16343640|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
16343641|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
16343642|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
16343643|NCT00316082|Drug|Saxagliptin|Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
16343644|NCT00316082|Drug|Placebo|Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
16343645|NCT00316082|Drug|metformin|Tablets, Oral, 500-2000 mg, as needed (12 months LT)
16343646|NCT00316043|Behavioral|Written information for parents|
16343647|NCT00316043|Behavioral|Distance learning package for General Practitioners|
16343648|NCT00316043|Behavioral|Distance learning package for practice assistants|
16343649|NCT00316030|Drug|Bexarotene|
16343650|NCT00316017|Drug|7.5% hypertonic saline/6% Dextran-70 (HSD)|250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.
16343651|NCT00316017|Drug|7.5% hypertonic saline (HS)|250 cc dose given as a one-time IV bolus in the pre-hospital setting.
16343652|NCT00316017|Drug|0.9% normal saline|250 cc dose given as a one-time IV bolus in the pre-hospital setting.
16343653|NCT00316004|Drug|7.5% Hypertonic Saline in 6% Dextran-70 (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
16343654|NCT00316004|Drug|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
16343754|NCT00315120|Procedure|C. Active OMT and sham UST|Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
16343655|NCT00316004|Drug|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
16343656|NCT00315991|Behavioral|Blood Glucose Awareness Training for Parents|
16343657|NCT00315978|Device|Heart-to-Heart Decision Aid|
16343658|NCT00315965|Drug|Nitric oxide, Carbon monoxide, Helium|
16343659|NCT00315952|Drug|Exubera|
16343660|NCT00315939|Device|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)|Integrated Biobehavioral Monitoring & Feedback-1 (IBMF-1): a hand-held computer (HHC) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index), and glucose variability (Average Daily Risk Range) using previously published algorithms. The subjects were asked to carry the HHC and enter all their self-monitored blood glucose (SMBG) readings. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.
16343661|NCT00315939|Device|Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)|Integrated Biobehavioral Monitoring & Feedback-2 (IMBF-2) retains IMBF-1, but the HHC asked subjects to provide symptom ratings when blood glucose (BG) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.
16343662|NCT00315926|Drug|Melatonin|Melatonin 50 mg during surgery and 10 mg every night for 3 nights
16343663|NCT00315926|Drug|Placebo|a mixture of ethanol and physiological saline
16343664|NCT00315913|Drug|Propranolol|IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg
16343665|NCT00315913|Other|IV Placebo|IV Saline Solution
16343666|NCT00315900|Drug|Depakote ER|depakote ER
16343667|NCT00315900|Drug|Seroquel|seroquel
16343668|NCT00315887|Drug|Buprenorphine transdermal delivery system|
16343669|NCT00315874|Drug|Buprenorphine transdermal delivery system|
16343670|NCT00315861|Drug|pemetrexed|
16343671|NCT00315861|Drug|topotecan|
16343672|NCT00315848|Drug|Buprenorphine transdermal delivery system|
16343673|NCT00315835|Drug|Buprenorphine transdermal delivery system|
16343674|NCT00315822|Other|80% oxygen|Supplemental oxygen will be administered during surgery
16343675|NCT00315822|Other|30% oxygen|Subjects undergoing surgery will receive routine administration of oxygen
16343676|NCT00315796|Device|Biophilic Nature Scene and Sound|
16343677|NCT00315770|Procedure|weight loss diets for young adults|
16343678|NCT00315757|Biological|Mapatumumab|10 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
16343679|NCT00315757|Biological|Mapatumumab|20 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
16343680|NCT00315757|Drug|Bortezomib|1.3 mg/m^2 IV (in the vein), twice weekly for two weeks (Days 1, 4, 8, and 11) of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
16343681|NCT00315744|Drug|Salmeterol/fluticasone|Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.
16343682|NCT00315744|Drug|Fluticasone propionate|Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
16343683|NCT00315744|Drug|Salbutamol|Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
16343684|NCT00315731|Biological|Follicular Lymphoma|For subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's
16343685|NCT00315718|Drug|Extract from Hintonia latiflora bark|
16343686|NCT00315705|Drug|clofarabine|Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
16343687|NCT00315705|Drug|Etoposide|Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
16343688|NCT00315705|Drug|Cyclophosphamide|Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
16343689|NCT00315692|Device|Biomarker Assay (CA125 and HE4)|
16343690|NCT00315679|Drug|Pentoxifylline (also known as oxpentifylline)|
16343691|NCT00315666|Drug|memantine|
16343692|NCT00315640|Drug|Anecortave Acetate Sterile Suspension, 6 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
16343693|NCT00315640|Drug|Anecortave Acetate Suspension Depot, 30 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
16343694|NCT00315640|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
16343695|NCT00315640|Other|Anecortave Acetate Vehicle|One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
16343696|NCT00315627|Drug|Islet transplantation|Islet transplantation
16343697|NCT00315614|Biological|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.
16343698|NCT00315601|Drug|Telithromycin|800 mg once a day for 5 days
16343699|NCT00315601|Drug|azithromycin|500 mg on day 1, and then 250 mg once-daily on days 2 through 5
16343700|NCT00315601|Procedure|bronchoalveolar lavage|One bronchoscopy with bronchoalveolar lavage with each drug administration
16343701|NCT00315601|Drug|Telithromycin|Telithromycin 800 mg once a day
16343702|NCT00315588|Drug|Islet Transplantation|Islet Transplantation in subjects with a previous kidney transplant.
16343755|NCT00315120|Procedure|D. Sham OMT and sham UST|Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
16343703|NCT00315575|Procedure|BOLD and Perfusion brain MRI|Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour
16343704|NCT00315562|Procedure|carotid endarterectomy|
16343705|NCT00315549|Drug|Telithromycin|
16343706|NCT00315549|Drug|Penicillin|
16343707|NCT00315536|Drug|Administration of remifentanil and glycopyrrolate|2 mg, intravenius use
16343708|NCT00315523|Drug|Levocetirizine|
16343709|NCT00315510|Drug|Rosuvastatin|
16343710|NCT00315484|Drug|Epoetin alfa and Darbepoetin alfa|
16343711|NCT00315458|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch applied for 7-day wear.
16343712|NCT00315458|Drug|Placebo transdermal patch|Placebo to match buprenorphine transdermal patch 10 or 20.
16343713|NCT00315445|Drug|Buprenorphine transdermal patch|Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
16343714|NCT00315445|Drug|Placebo oxycodone/acetaminophen tablets|Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
16343715|NCT00315445|Drug|OXY/APAP|5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
16343716|NCT00315445|Drug|Placebo transdermal patch (TDS)|Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
16343717|NCT00315432|Drug|Pegylated Interferon and Ribavirin|
16343718|NCT00315367|Drug|Donepezil HCI (drug)|
16343719|NCT00315354|Other|Low glycemic index diet|Feeding protocol, all foods prepared in a metabolic kitchen
16343720|NCT00315354|Other|Low fat diet|Feeding protocol, all foods prepared in a metabolic kitchen
16343721|NCT00315354|Other|Very low carbohydrate diet|Feeding protocol, all foods prepared in a metabolic kitchen
16343722|NCT00315341|Drug|Buprenorphine/naloxone|Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.
16343723|NCT00315341|Drug|Methadone|Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.
16343724|NCT00315328|Drug|Atropine|Atropine 1% each weekend day in the sound eye
16343725|NCT00315328|Device|Patching|Patching 2 hours per day
16343726|NCT00315328|Procedure|Near activities|near visual activities for at least one hour per day
16343727|NCT00315315|Procedure|Nasolacrimal balloon catheter dilation|Balloon catheter nasolacrimal duct dilation consists of punctal dilation of at least one punctum and the passage into the nose of a semi-flexible wire probe with an inflatable balloon on the tip.
16343728|NCT00315315|Procedure|Nasolacrimal intubation|Nasolacrimal duct intubation consists of punctal dilation of at least one punctum with the passage of a flexible lacrimal probe into the nose and the placement of a temporary stent in the nasolacrimal duct.
16343729|NCT00315315|Procedure|Nasolacrimal duct probing|Simple nasolacrimal duct probing consists of punctal dilation of at least one punctum and the passage of a probe into the nose.
16343730|NCT00315302|Drug|Atropine|Atropine 1% once each weekend day
16343731|NCT00315302|Device|Plano Lens|Plano lens for the sound eye
16343732|NCT00315289|Procedure|Nasolacrimal balloon catheter duct dilation|
16343733|NCT00315289|Procedure|Nasolacrimal intubation|
16343734|NCT00315289|Procedure|Simple Nasolacrimal duct probing|
16343735|NCT00315276|Drug|Modafinil|
16343736|NCT00315250|Drug|[123I]β-CIT|"Single Photon Emission Computed Tomography
~SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI."
16343737|NCT00315237|Drug|vinflunine and best supportive care|solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
16343738|NCT00315224|Behavioral|heart-rate controlled 12 week exercise program|
16343739|NCT00315211|Drug|Intravenous Topotecan|Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
16343740|NCT00315211|Drug|Intravenous Docetaxel|Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
16343741|NCT00315198|Device|Eye Patch|2 hours daily patching
16343742|NCT00315198|Procedure|Near activities|near visual activities while patching
16343743|NCT00315198|Procedure|Distance activities|distance visual activities while patching
16343744|NCT00315185|Drug|Cetuximab|
16343745|NCT00315172|Procedure|Non-Exercise Activity Thermogenesis (NEAT)|
16343746|NCT00315159|Procedure|Sentinel Node Biopsy|Inguinal sentinel node biopsy will be performed.
16343747|NCT00315146|Drug|Pioglitazone|
16343748|NCT00315146|Behavioral|Resistance exercise training to maximize muscle power|
16343749|NCT00315146|Behavioral|Hypocaloric diet|
16343750|NCT00315146|Drug|Placebo|
16343751|NCT00315133|Procedure|Immunosuppression and autologous stem cell transplantation|Immunosuppression and autologous stem cell transplantation: Mobilization of hematopoietic stem cells (HSC) with cyclophosphamide (2 g/m2) and granulocyte-colony stimulating factor (G-CSF, 10 ug/kg/d), followed by collection and cryopreservation of unselected HSC and conditioning with cyclophosphamide (200 mg/kg) plus rabbit anti-thymocyte globulin (ATG 4.5 mg/kg).
16343752|NCT00315120|Procedure|A. Active OMT and active UST|Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
16343753|NCT00315120|Procedure|B. Sham OMT and active UST|Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
16343756|NCT00315107|Drug|Alesse|
16343757|NCT00315094|Behavioral|Caregiving support interventions (FamTechCare)|One set of combined interventions to be tested in this study are nursing interventions for the prevention of catheter-related infection, reactive depression, and HPN home care problem-solving. The other set of combined interventions are for increasing social support and use of a short nap to reduce daily fatigue. Information about all the interventions were incorporated into Internet formats as a booster for reinforcement.
16343758|NCT00315081|Drug|Bromocriptin|
16343759|NCT00315055|Biological|DTaP-IPV-HB-PRP~T vaccine|0.5 mL, Intramuscular (IM)
16343760|NCT00315055|Biological|DTaP-IPV//PRP~T combined|0.5 mL, IM
16343761|NCT00315055|Biological|Hepatitis B vaccine|0.5 mL, IM
16343762|NCT00315042|Drug|Telithromycin (HMR3647)|
16343763|NCT00315042|Drug|Penicillin|
16343764|NCT00315029|Behavioral|evidence based decision aid|evidence based decision aid
16343765|NCT00315029|Behavioral|Possible reimbursement 4th IVF/ICSI cycle when necessary|Potential reimbursement 4th IVF/ICSI cycle when necessary
16343766|NCT00315016|Drug|eplerenone|active comparator
16343767|NCT00315016|Drug|fosinopril|doubling of fosinopril dose
16343768|NCT00315016|Drug|placebo|placebo (double dummy)
16343769|NCT00315003|Drug|Telithromycin|
16343770|NCT00315003|Drug|Azithromycin|
16343771|NCT00314990|Drug|5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin|
16343772|NCT00314977|Drug|Doxorubicin|doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
16343773|NCT00314977|Drug|Cyclophosphamide|Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
16343774|NCT00314977|Drug|Docetaxel|Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
16343775|NCT00314964|Drug|PD-0299685|
16343776|NCT00314951|Drug|Fidaxomicin|200 mg oral capsules two times daily (q12h regimen)
16343777|NCT00314951|Drug|Vancomycin|125 mg capsules q6hr (4 times a day)
16343778|NCT00314951|Drug|Matching Placebo to Fidaxomicin|Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
16343779|NCT00314938|Drug|PHA-794428|
16343780|NCT00314925|Drug|Seneca Valley Virus (biological agent)|Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration
16343781|NCT00314912|Drug|Tramiprosate (3APS)|
16343782|NCT00314886|Drug|Diet|
16343783|NCT00314873|Drug|Gleevec (imatinib)|Imatinib 600mg po qd X 21 days.
16343784|NCT00314860|Drug|ropinirole Extended Release (XR)|
16343785|NCT00314847|Device|Extra-Corporeal Life Support -Impella 2.5|Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)
16343786|NCT00314834|Drug|Intradialytic parenteral nutrition|
16343787|NCT00314821|Drug|ropinirole|
16343788|NCT00314808|Drug|Dronabinol|Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy
16343789|NCT00314795|Drug|Peginesatide|Peginesatide injection
16343790|NCT00314782|Drug|ZD4054 (Zibotentan)|oral tablet
16343791|NCT00314782|Drug|Docetaxel|intravenous infusion
16343792|NCT00314782|Drug|Placebo|
16343793|NCT00314756|Drug|imiquimod|
16343794|NCT00314743|Drug|Ondansetron|
16343795|NCT00314743|Drug|Dexamethasone|
16343796|NCT00314743|Drug|Aprepitant|
16343797|NCT00314730|Device|handheld Personal Digital Assistant (PDA)|
16343798|NCT00314717|Behavioral|Control diet|
16343799|NCT00314717|Behavioral|Low GI diet|
16343800|NCT00314704|Drug|dopamine versus norepinephrine|
16343801|NCT00314691|Genetic|Blood samples|
16343802|NCT00314678|Drug|Topotecan|
16343803|NCT00314678|Drug|Cisplatin|
16343804|NCT00314678|Drug|Paclitaxel|
16343805|NCT00314665|Drug|Thalidomide|
16343806|NCT00314652|Drug|Buprenorphine transdermal delivery system|
16343807|NCT00314639|Drug|modafinil|Modafinil OR Placebo 100mg orally (on the morning) from day 0 to day 14 and 200mg orally (on the morning) from day 15 to day 28. AND REVERSE : Modafinil OR Placebo 100mg orally (on the morning) from day 42 to day 56 and 200mg orally (on the morning) from day 57 to day 70.
16343808|NCT00314626|Drug|efavirenz|Efavirenz
16343809|NCT00314626|Drug|Abacavir+lamivudine|Abacavir+lamivudine
16343810|NCT00314613|Drug|Antipsychotic/Risperidone Consta|
16343811|NCT00314600|Device|above and below elbow cast|
16343812|NCT00314587|Procedure|1 or 2 elastic stable intramedullary nails|
16343813|NCT00314574|Drug|omalizumab (Xolair)|Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP.
16343814|NCT00314574|Drug|placebo|Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab.
16343815|NCT00314574|Drug|corticosteroids|Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day.
16343816|NCT00314574|Drug|long-acting beta-agonists|50 µg salmeterol twice daily or 12 µg formoterol twice daily.
16343817|NCT00314561|Drug|Pioglitazone, Rosiglitazone|
16343818|NCT00314548|Drug|PGE1 (prostacyclin)|alprostadil nebulization
16343819|NCT00314548|Drug|normal saline|nebulize for 30 mins
16343820|NCT00314509|Drug|Ciclesonide/Formoterol Combination|
16343821|NCT00314483|Drug|Mesenchymal Stem Cell Infusion|
16343822|NCT00314457|Drug|Bupivacaine|Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.
16343823|NCT00314431|Procedure|Care coordination by telephone contacts with a nurse|
16343824|NCT00314418|Procedure|Colonoscopy in the prone position|
16343825|NCT00314405|Drug|Methylene blue (1%)|
16343826|NCT00314405|Drug|Rhenium sulfure|
16343827|NCT00314405|Procedure|Surgical procedure|
16343828|NCT00314405|Procedure|Anatomo-pathologic procedure|
16343829|NCT00314392|Behavioral|Information (behavior)|
16343830|NCT00314379|Drug|Vitamin E 400IU/day|
16343942|NCT00313573|Procedure|psychosocial assessment and care|
16343831|NCT00314366|Biological|Stem Cell Therapy|Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.
16343832|NCT00314366|Other|Control (plasma)|Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
16343833|NCT00314353|Drug|Bevacizumab|"7.5 mg/kg IV Day 1 every 21 days for eight cycles*
~*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression."
16343834|NCT00314353|Drug|Oxaliplatin|130 mg/m2 IV Day 1 every 21 days for eight cycles
16343835|NCT00314353|Drug|Capecitabine|"850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#
~*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.
~#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID"
16343836|NCT00314353|Drug|Irinotecan|200 mg/m2 IV Day 1 every 21 days for eight cycles
16343837|NCT00314340|Behavioral|Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity|The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.
16343838|NCT00314340|Drug|ER Morphine|
16343839|NCT00314340|Drug|hydrocodone plus acetaminophen|
16343840|NCT00314340|Drug|placebo|
16343841|NCT00314327|Drug|long-acting injectable risperidone|One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
16343842|NCT00314314|Drug|Intranasal Insulin|Intranasal spray; 40 IU qid; 8 weeks
16343843|NCT00314314|Drug|Diluent|Intranasal spray; 8 weeks
16343844|NCT00314301|Device|loaded sit-to-stand training|
16343845|NCT00314288|Drug|Sarizotan HCl|
16343846|NCT00314275|Device|Coronary Artery Stenting|Drug eluting stent
16343847|NCT00314275|Device|Endeavor|Drug eluting stent
16343848|NCT00314262|Drug|Erlotinib & Celecoxib|"Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.
~Celecoxib given 400 mg orally BID continuously for 6 months."
16343849|NCT00314249|Drug|Placebo|Placebo, oral administration, twice daily for 12 weeks
16343850|NCT00314249|Drug|Milnacipran 100mg|Milnacipran 100mg per day (50mg BID [twice a day])
16343851|NCT00314236|Device|BST-CarGel with Microfracture|Microfracture performed with BST-CarGel added to the treated defect
16343852|NCT00314236|Procedure|Microfracture without BST-CarGel|Microfracture performed without BST-CarGel added to the treated defect.
16343853|NCT00314210|Drug|Quetiapine SR|
16343854|NCT00314197|Behavioral|Telephone Linked Care - Behavior Change Counseling System|
16343855|NCT00314197|Behavioral|Telephone-linked behavioral counseling|
16343856|NCT00314184|Drug|quetiapine fumarate|
16343857|NCT00314171|Drug|Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension|One drop in the study eye(s) twice daily for 12 months
16343858|NCT00314171|Drug|Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)|One drop in the study eye(s) twice daily for 12 months
16343859|NCT00314158|Drug|Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension|One drop twice daily in each study eye for six months
16343860|NCT00314158|Drug|Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension|One drop twice daily in each study eye for six months
16343861|NCT00314158|Drug|Timolol 5 mg/ml eye drops, solution|One drop twice daily in each study eye for six months
16343862|NCT00314145|Biological|ChimeriVax™-JE|0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
16343863|NCT00314145|Biological|JE-VAX®|0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
16343864|NCT00314132|Biological|ChimeriVax-JE, Japanese Encephalitis vaccine|0.5 mL, Subcutaneous
16343865|NCT00314132|Biological|0.9% Saline|0.5 mL, Subcutaneous
16343866|NCT00314106|Biological|Melanoma Reactive TIL|
16343867|NCT00314106|Drug|Cyclophosphamide|60 mg/kg/ day x 2 days intravenous
16343868|NCT00314106|Biological|IL-2|720,000 IU/kg/dose every 8 hours for up to 15 doses
16343869|NCT00314106|Drug|Fludarabine|25 mg/m^2/day intravenous x 5 days
16343870|NCT00314106|Radiation|1200 total body irradiation (TBI)|1200 cGY total body radiation
16343871|NCT00314093|Drug|RFT5pdgA|
16343872|NCT00314080|Drug|Botulinum AntiToxin|
16343873|NCT00314080|Procedure|neuro-electrophysiologic study, repetitive nerve stimulation|
16343874|NCT00314080|Procedure|Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure|
16343875|NCT00314067|Procedure|Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care|
16343876|NCT00314067|Procedure|Physician training|
16343877|NCT00314067|Procedure|Practice team training|
16343878|NCT00314054|Drug|HCV-796|HCV-796 1000mg single dose
16343879|NCT00314041|Biological|Meningococcal C|
16343880|NCT00314041|Biological|DTP/Hib|
16343881|NCT00314028|Behavioral|Focus on the Future|Focus on the Future is an educational program designed to promote proper condom use.
16343882|NCT00314028|Other|Control standard of care treatment|Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
16343883|NCT00314015|Procedure|Evaluation of the success rate of implants|Evaluation of the success rate of implants will be followed.
16343884|NCT00314015|Procedure|Questionnaires|Questionnaires will be used
16343885|NCT00314002|Device|Mechanical Thrombectomy|
16343886|NCT00313989|Procedure|Evaluation of the success rate of implants|Evaluation of the success rate of implants
16343887|NCT00313976|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|250 micrograms every other day, subcutaneously for 104 weeks
16343888|NCT00313976|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2x250 micrograms every other day, subcutaneously for 104 weeks
16343889|NCT00313963|Drug|Magnesium Sulfate|Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
16343890|NCT00313963|Drug|Normal Saline|Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
16343891|NCT00313950|Biological|Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella|0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
16343892|NCT00313950|Biological|Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine|0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
16343893|NCT00313950|Biological|Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella|0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
16343894|NCT00313937|Drug|Insulin glargine|
16343895|NCT00313924|Drug|DETRUSITOL|
16343896|NCT00313911|Biological|DTaP-IPV-HB-PRP~T|0.5 mL, Intramuscular (IM)
16343897|NCT00313911|Biological|Tritanrix-HepB/Hib|0.5 mL, Intramuscular
16343898|NCT00313898|Drug|sildenafil (viagra)|
16343899|NCT00313885|Drug|eplivanserin (SR46349)|oral administration
16343900|NCT00313885|Drug|placebo|oral administration
16343901|NCT00313872|Drug|DP|D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre & Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre & post hydration (if Mg <WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks
16343902|NCT00313872|Drug|FOLFIRI|FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
16343903|NCT00313859|Drug|simvastatin|
16343904|NCT00313846|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
16343905|NCT00313846|Drug|Placebo|Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
16343906|NCT00313833|Drug|Buprenorphine transdermal delivery system|
16343907|NCT00313820|Drug|Pregabalin|Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
16343908|NCT00313820|Drug|Placebo|Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
16343909|NCT00313807|Drug|Amino Acid|7% amino acid infusion
16343910|NCT00313807|Drug|Placebo|0.9% Saline Infusion
16343911|NCT00313794|Drug|CP-675,206|15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.
16343912|NCT00313781|Drug|CP-751,871|CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).
16343913|NCT00313781|Drug|docetaxel|Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
16343914|NCT00313781|Drug|prednisone|Prednisone is administered at a dose of 5 mg twice daily.
16343915|NCT00313781|Drug|docetaxel|Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
16343916|NCT00313781|Drug|prednisone|Prednisone is administered at a dose of 5 mg twice daily.
16343917|NCT00313768|Drug|paclitaxel + carboplatin + bevacizumab|paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
16343918|NCT00313768|Drug|carboplatin + paclitaxel + bevacizumab + PF-3512676|carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
16343919|NCT00313755|Procedure|Narrow Band Imaging|
16343920|NCT00313742|Drug|insulin detemir|
16343921|NCT00313742|Drug|insulin glargine|
16343922|NCT00313742|Drug|insulin NPH|
16343923|NCT00313729|Drug|temozolomide|Chemotherapy
16343924|NCT00313716|Drug|recombinant human erythropoietin, rhEpo|The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (first 74 patients, Epo1 dosing regimen), and then the 24- and 48-hour doses were stopped for the remainder of the patients (remaining 126 patients, Epo2 dosing regimen).
16343925|NCT00313716|Other|placebo|an inactive substance
16343926|NCT00313690|Drug|Bortezomib, Docetaxel and Cisplatin|
16343927|NCT00313625|Drug|busulfan|
16343928|NCT00313625|Drug|melphalan|
16343929|NCT00313625|Drug|methotrexate|
16343930|NCT00313625|Drug|tacrolimus|
16343931|NCT00313625|Procedure|allogeneic hematopoietic stem cell transplantation|
16343932|NCT00313625|Procedure|peripheral blood stem cell transplantation|
16343933|NCT00313612|Drug|oxaliplatin|Given IV
16343934|NCT00313612|Drug|topotecan|Given IV
16343935|NCT00313599|Drug|lapatinib|
16343936|NCT00313599|Drug|paclitaxel|
16343937|NCT00313586|Drug|Azacitidine|Given SC
16343938|NCT00313586|Drug|Entinostat|Given PO
16343939|NCT00313586|Other|Laboratory Biomarker Analysis|Correlative studies
16343940|NCT00313573|Procedure|management of therapy complications|
16343941|NCT00313573|Procedure|pain therapy|
16343943|NCT00313573|Procedure|quality-of-life assessment|
16343944|NCT00313560|Drug|erlotinib hydrochloride|Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
16343945|NCT00313547|Drug|Quinapril 40 mg|
16343946|NCT00313547|Drug|Quinapril 10 mg and amlodipine 5 mg|
16343947|NCT00313534|Drug|masoprocol|
16343948|NCT00313521|Drug|thiotepa|
16343949|NCT00313521|Procedure|adjuvant therapy|
16343950|NCT00313521|Radiation|radiation therapy|
16343951|NCT00313508|Biological|Autologous Dendritic Cells (DC)|Given intranodally
16343952|NCT00313508|Drug|Fludarabine|Fludarabine will be administered intravenously (IV) over 30 minutes, daily for 5 consecutive days.
16343953|NCT00313508|Biological|Autologous Lymphocyte Infusion (ALI)|Infusion
16343954|NCT00313482|Drug|Sargramostim|250 mcg/m2 SC days 2-15 of each cycle
16343955|NCT00313482|Drug|Docetaxel|75 mg/m2 IV over 1 hour on Day 1 of each cycle
16343956|NCT00313482|Drug|Prednisone|5 mg orally BID on Day 1 continuously
16343957|NCT00313456|Drug|Satraplatin|Satraplatin is an oral platinum analogue that has shown promising activity in multiple tumor settings. Satraplatin (40 to 80 mg/m2/day) will be administered orally on days 1 to 5 of a 21 day cycle.
16343958|NCT00313443|Procedure|Fat tissue needle aspiration|Small fat tissue sampling performed by needle aspiration.
16343959|NCT00313417|Dietary Supplement|Creatine monohydrate|Up to 10 grams
16343960|NCT00313417|Other|Placebo|Placebo will be given in the same way and appearance as the active treatment
16343961|NCT00313404|Biological|Safety tested norovirus inoculum|This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards
16343962|NCT00313391|Drug|Risperdal Consta|
16343963|NCT00313378|Drug|Hypothetica|
16343964|NCT00313365|Procedure|Surgical Lavage (Arthrotomy)|
16343965|NCT00313365|Procedure|Arthrocentesis (Serial needle aspiration)|
16343966|NCT00313339|Drug|Intra-coronary infusion|In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
16343967|NCT00313326|Procedure|Adaptative Support Ventilation|Adaptive Support Ventilation (ASV) is a new protocol of weaning of the tracheal prosthesis after surgery which maintains a preset ventilation by an operator, and this whatever the activity of the patient
16343968|NCT00313313|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
16343969|NCT00313313|Drug|Saxagliptin|Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
16343970|NCT00313313|Drug|Glyburide|Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
16343971|NCT00313313|Drug|Placebo|Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
16343972|NCT00313313|Drug|Glyburide|Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
16343973|NCT00313313|Drug|Metformin|Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
16343974|NCT00313300|Drug|Apixaban|Tablets, Oral, 2.5 mg, twice daily, 26 weeks
16343975|NCT00313300|Drug|Apixaban|Tablets, Oral, 10 mg, once daily, 26 weeks
16343976|NCT00313300|Drug|Placebo|Tablets, Oral, 0, twice daily, 26 weeks
16343977|NCT00313300|Drug|Apixaban|Tablets, Oral 10 mg, twice daily, 26 weeks
16343978|NCT00313287|Drug|clevudine|
16343979|NCT00313274|Drug|Clevudine|
16343980|NCT00313261|Drug|Clevudine|
16343981|NCT00313248|Drug|Sagopilone (ZK 219477)|All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
16343982|NCT00313248|Drug|Sagopilone (ZK 219477)|Patients will receive 22mg/m2 as intravenous infusion.
16343983|NCT00313235|Biological|DC Vaccine and Cyclophosphamide|"Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site).
~Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks.
~CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure."
16343984|NCT00313222|Drug|bosentan|
16343985|NCT00313209|Drug|Roflumilast|500 µg, once daily, oral administration in the morning
16343986|NCT00313209|Drug|Placebo|once daily
16343987|NCT00313196|Drug|bosentan|Oral Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, maintenance dose: 125 mg
16343988|NCT00313183|Drug|pramlintide acetate|single subcutaneous doses of 15mcg and 30mcg
16343989|NCT00313170|Drug|Fulvestrant|intramuscular injection 250 mg & 500 mg
16343990|NCT00313157|Drug|Metoprolol|
16343991|NCT00313157|Drug|Diltiazem|
16343992|NCT00313157|Drug|Verapamil|
16343993|NCT00313157|Drug|Carvedilol|
16343994|NCT00313144|Drug|ARALAST Alpha1-Proteinase Inhibitor|Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician
16343995|NCT00313131|Drug|tinidazole+fluconazole vs metronidazole+clotrimazole|
16343996|NCT00313105|Drug|Smokeless tobacco (Oliver Twist pellets)|individual visits with counseling
16343997|NCT00313105|Behavioral|smoking cessation counseling|individual visits
16343998|NCT00313092|Device|nCPAP treatment|treatment with positive air pressure during night
16343999|NCT00313079|Drug|MAb 216|Dosage: 1.25mg/kg intravenous with dose escalation
16344000|NCT00313079|Drug|Vincristine|Dosage: 1.5mg/m2 intravenous weekly X 4
16344001|NCT00313053|Drug|Human mAb 216|Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.
16344002|NCT00313053|Drug|Vincristine|Vincristine 1.5 mg/m2/dose (max dose = 2 mg) IVP on weekly x 4 doses (Days 7, 14, 21, 28)
16344003|NCT00313040|Behavioral|Brief Consultation with Health Counselor, workbook|
16344004|NCT00313040|Behavioral|Usual Care wait list|
16344005|NCT00313027|Radiation|PET scan|
16344006|NCT00313014|Drug|Buprenorphine|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
16344007|NCT00313014|Drug|Buprenorphine|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
16344008|NCT00313014|Drug|Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
16344009|NCT00313001|Drug|biphasic insulin aspart|
16344010|NCT00313001|Drug|exenatide|
16344011|NCT00312988|Drug|Hycamtin|
16344012|NCT00312988|Drug|Gemcitabine|
16344013|NCT00312975|Drug|CP-675,206|Given intravenously every 3 months
16344014|NCT00312975|Drug|best supportive care|As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
16344015|NCT00312962|Behavioral|Targeted cognitive training (TCT)|TCT includes cognitive remediation exercises that participants practice 1 hour per day, 5 days per week, for 20 weeks. TCT exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets.
16344016|NCT00312962|Behavioral|Computer games|The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.
16344017|NCT00312949|Behavioral|Interactive Website on management of schizophrenia|Participants in the web-user group will sit with a laptop computer, answer questions about themselves and their treatment, receive feedback on care that may be inconsistent with current recommendations, and receive suggestions on how to discuss this with their physicians.
16344018|NCT00312949|Behavioral|Written materials and video on management of schizophrenia|Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.
16344019|NCT00312936|Behavioral|Mindfulness-based Stress Reduction (MBSR)|8 week program
16344020|NCT00312923|Drug|Policosanol|20 mg of policosanol in capsular form daily
16344021|NCT00312923|Dietary Supplement|Placebo|Two capsules of 10 mg of microcrystalline cellulose daily
16344022|NCT00312910|Drug|Probiotics-Bio-plus|
16344023|NCT00312897|Drug|Omega-3 Fatty Acids|10 wk treatment period
16344024|NCT00312897|Drug|corn oil|placebo comparator
16344025|NCT00312884|Device|HomMed Telemonitoring System|The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
16344026|NCT00312871|Drug|Epoetin alfa|
16344027|NCT00312858|Biological|Comparator: VAQTA™ (Hepatitis A vaccine)|VAQTA™ 0.5 mL injection
16344028|NCT00312858|Biological|Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)|ProQuad™ 0.5 mL injection
16344029|NCT00312858|Biological|Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)|Prevnar™ 0.5 mL injection
16344030|NCT00312845|Drug|Bortezomib + Rituximab|VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.
16344031|NCT00312845|Drug|Rituximab|rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
16344032|NCT00312832|Drug|switching; dose reduction|
16344033|NCT00312819|Drug|chemotherapy +/- disulfiram|
16344034|NCT00312806|Drug|Pantoprazole|Pantoprazole 40 mg o.d.
16344035|NCT00312793|Device|stimulation of the quadriceps muscle with Myospare|
16344036|NCT00312780|Drug|XL784|XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
16344037|NCT00312767|Drug|Fabrazyme (agalsidase beta)|
16344038|NCT00312754|Drug|Atazanavir|
16344039|NCT00312741|Procedure|empirical versus microbiological guided treatment|
16344040|NCT00312728|Drug|bevacizumab|15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be < 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity.
16344041|NCT00312728|Drug|First-Line Chemotherapy Agents|"Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily.
~All agents were dosed and administered per institutional standards using the respective package insert as a guideline."
16344042|NCT00312728|Drug|Second-Line Chemotherapy Agents|"Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued.
~All agents were dosed and administered per institutional standards using the respective package insert as a guideline."
16344043|NCT00312702|Biological|Falciparum Malaria Protein 11 with AS02A adjuvant|vaccine
16344044|NCT00312676|Procedure|Rapid versus slow conversion|
16344045|NCT00312663|Biological|Falciparum Malaria Protein 11 with AS01B adjuvant.|malaria experimental vaccine
16344046|NCT00312650|Drug|liposomal doxorubicin and gemcitabine|
16344047|NCT00312637|Procedure|Magnetic Resonance Spectroscopy|
16344048|NCT00312624|Procedure|contrast-enhanced cardiac MRI|MRI of heart with delayed enhancement
16344049|NCT00312611|Device|Transcend II Implantable Gastric Stimulator (IGS), Model 8848|
16344050|NCT00312598|Drug|Aripiprazole|
16344051|NCT00312585|Procedure|Acupuncture|
16344052|NCT00312585|Procedure|Sham comparator|
16344053|NCT00312572|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch applied for 7-day wear.
16344054|NCT00312559|Behavioral|Yoga Training|
16344055|NCT00312546|Drug|Enfuvirtide|90 mg subcutaneously twice daily
16344056|NCT00312546|Drug|Valproic acid|500 to 750 mg, taken orally twice daily
16344057|NCT00312533|Drug|Hylan F- 20|
16344058|NCT00312520|Drug|prednisolone|
16344059|NCT00312520|Drug|methylprednisolone|
16344060|NCT00312507|Drug|Bovine Lipid Extract Surfactant (administered by lavage)|
16344061|NCT00312507|Drug|Bovine Lipid Extract Surfactant (administered by bolus)|
16344062|NCT00312494|Drug|Placebo|Placebo with mood stabilizer (either lithium or divalproex)
16344063|NCT00312494|Drug|Ziprasidone|Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
16344064|NCT00312494|Drug|Ziprasidone|Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
16344065|NCT00312481|Drug|macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate|Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy
16344066|NCT00312481|Drug|NA picosulfate magnesium citrate|150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.
16344067|NCT00312455|Drug|Pro-eicosapentaenoic acid (EPA)|450 mg 5x/day
16344068|NCT00312455|Drug|Pro-docosapentaenoic acid (DPA)|100mg 5x/day
16344069|NCT00312455|Drug|Placebo|5 capsules/day
16344070|NCT00312442|Drug|Treatment with WST09 Vascular Photodynamic therapy|
16344071|NCT00312429|Procedure|Stem Cell Transplantation|Allogeneic umbilical cord blood stem cell transplant
16344072|NCT00312416|Drug|Clonidin|
16344073|NCT00312416|Drug|Brimonidine|
16344074|NCT00312403|Procedure|Blood Sample|A single venous blood sample will be taken (10 ml).
16344075|NCT00312390|Procedure|Flicker|
16344076|NCT00312390|Procedure|Retinal Vessel Diameter|
16344077|NCT00312390|Procedure|Retinal Blood Flow|
16344078|NCT00312377|Drug|Docetaxel|infusion
16344079|NCT00312377|Drug|Vandetanib|oral
16344080|NCT00312364|Drug|MRE0094|
16344081|NCT00312351|Drug|Pegaptanib sodium|
16344082|NCT00312338|Drug|VIGAMOX|1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
16344083|NCT00312325|Drug|Prednisolone|
16344084|NCT00312312|Biological|Specific immunotherapy|
16344085|NCT00312299|Device|Square edge PMMA IOL|Arm 1 A - Square edge PMMA IOL
16344086|NCT00312299|Device|Round edge PMMA IOL|Round edge PMMA IOL
16344087|NCT00312299|Device|Acrysof IOL|Acrysof IOL
16344088|NCT00312299|Device|square Edge PMMA IOL|Square edge PMMA intra ocular lens
16344089|NCT00312299|Device|Square Edge PMMA IOL|Square Edge PMMA IOL lens
16344090|NCT00312286|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16344091|NCT00312286|Drug|851B|851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
16344092|NCT00312286|Drug|851B|851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
16344093|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, once a week for 1 cycle.
16344094|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, once a week for 2 cycles.
16344095|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
16344096|NCT00312286|Drug|851B|851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
16344097|NCT00312286|Drug|851B|851B placebo-matching gel, topically, once a week for 1 cycle.
16344098|NCT00312286|Drug|851B|851B placebo-matching gel, topically, twice a week for 1 cycle.
16344099|NCT00312286|Drug|851B|851B placebo-matching gel, topically, once a week for 2 cycles.
16344100|NCT00312286|Drug|851B|851B placebo-matching gel, topically, twice a week for 2 cycles.
16344101|NCT00312273|Drug|Aminophylline (250mg IV +/- a second dose of 250mg IV)|
16344102|NCT00312260|Drug|Gabapentin|Gabapentin will be prescribed at 900mg/d (300mg tid). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
16344103|NCT00312260|Drug|Amitriptyline|Amitriptyline will be prescribed at a dose of 10mg (qhs). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
16344104|NCT00312234|Behavioral|Aerobic exercise|
16344105|NCT00312234|Behavioral|Qigong exercise|
16344106|NCT00312221|Drug|Buprenorphine|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
16344107|NCT00312221|Drug|Buprenorphine|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
16344108|NCT00312221|Drug|oxycodone immediate-release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
16344109|NCT00312208|Drug|docetaxel, doxorubicin, cyclophosphamide|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
16344110|NCT00312208|Drug|Docetaxel,doxorubicin, cyclophosphamide|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
16344111|NCT00312195|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
16344112|NCT00312195|Drug|Placebo to match BTDS|Placebo to match buprenorphine transdermal patch applied for 7-day wear.
16344113|NCT00312182|Drug|Nelfinavir|
16344114|NCT00312156|Drug|insulin detemir|
16344115|NCT00312156|Drug|insulin NPH|
16344116|NCT00312156|Drug|insulin aspart|
16344117|NCT00312143|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16344118|NCT00312130|Drug|Vildagliptin|
16344119|NCT00312117|Drug|Sodium bicarbonate|
16344120|NCT00312104|Drug|insulin detemir|
16344121|NCT00312104|Drug|insulin glargine|
16344122|NCT00312104|Drug|insulin aspart|
16344123|NCT00312091|Drug|Lamivudine, nevirapine, and stavudine fixed-dose tablet|7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
16344124|NCT00312091|Drug|Lamivudine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
16344125|NCT00312091|Drug|Nevirapine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
16344126|NCT00312091|Drug|Stavudine|Dosage dependent on weight. More information on this criterion can be found in the protocol.
16344127|NCT00312078|Dietary Supplement|Yogurt Supplementation|
16344128|NCT00312065|Device|Application of reflective heat shield to thermistor probe|
16344129|NCT00312052|Drug|E5555|50 mg or 100 mg E5555 tablets
16344130|NCT00312052|Drug|Placebo|50 mg and/or 100 mg placebo tablets
16344131|NCT00312039|Drug|elvucitabine|Elvucitabine 10 mg QD for 14days
16344132|NCT00312039|Drug|Lamivudine|Lamivudine 300 mg QD for 14 days
16344133|NCT00312026|Drug|efalizumab|
16344134|NCT00312013|Drug|Nadroparin|Patients will received all standard anti-cancer treatments. Therapeutic doses of nadroparin will be administered, subcutaneous for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2 week periods of therapeutic doses will be given for a total of 6 cycles each separated by a 4 week wash out. The study treatment period ends at week 46 regardless of the number of cycles achieved.
16344135|NCT00312000|Drug|capecitabine-irinotecan|"st line capecitabine 1250 mg/m2 orally b.i.d. on day 1-14
~nd line q 3 w irinotecan 350 mg/m2 IV infusion on day 1"
16344136|NCT00312000|Drug|capecitabine+irinotecan (1st line)|q 3 w irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 2 hours after discontinuation of the infusion followed by capecitabine 1000 mg/m2 orally b.i.d. on day 1-14
16344137|NCT00311987|Drug|3,5-Diiodothyropropionic acid (DITPA) therapy|
16344138|NCT00311974|Drug|Dihydralazine|
16344139|NCT00311961|Drug|Intravenous prednisolone|
16344140|NCT00311961|Drug|Oral prednisolone|
16344141|NCT00311948|Behavioral|Telephone counseling + interactive website = more abstinence|
16344142|NCT00311948|Behavioral|Behavioral: interactive website|
16344143|NCT00311935|Procedure|method of hernia repair|
16344144|NCT00311922|Behavioral|Literacy/Numeracy oriented educational intervention|Comprehensive educational Intervention
16344145|NCT00311922|Behavioral|Control Group|Receives comprehensive education that is not literacy/numeracy sensitive
16344146|NCT00311909|Device|Thalamic deep brain stimulation|
16344147|NCT00311896|Drug|Bemiparin|
16344148|NCT00311896|Drug|Placebo|
16344149|NCT00311883|Drug|hydroxychloroquine|
16344150|NCT00311870|Drug|nisoldipine|
16344151|NCT00311870|Drug|lisinopril|
16344152|NCT00311857|Drug|Cetuximab|
16344153|NCT00311857|Drug|Temozolomide|
16344154|NCT00311857|Procedure|Radiation therapy|
16344155|NCT00311844|Drug|desloratadine|
16344156|NCT00311831|Behavioral|Standard gastroenteritis education|Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
16344157|NCT00311831|Behavioral|Extensive gastroenteritis education|Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
16344158|NCT00311818|Drug|Insulin glargine|
16344159|NCT00311805|Biological|Autologous Stem Cells (CD34+)|Intramuscular Injections
16344160|NCT00311792|Behavioral|LapSimGyn training until expert proficiency level is reached|Two consecutive simulations reaching predefined expert level
16344161|NCT00311792|Behavioral|Traditional clinical education|
16344162|NCT00311779|Drug|Spinosad Creme Rinse|
16344163|NCT00311766|Drug|Thymosin Beta 4|Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
16344164|NCT00311766|Drug|Placebo|Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days
16344165|NCT00311753|Drug|Certoparin|Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
16344166|NCT00311753|Drug|Heparin|7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
16344167|NCT00311740|Drug|Valsartan|
16344168|NCT00311740|Drug|Hydrochlorothiazide|
16344169|NCT00311727|Biological|Influenza A/H5N1|232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.
16344170|NCT00311714|Drug|CS-8958 formulated as dry powder|
16344171|NCT00311714|Other|Placebo|
16344172|NCT00311688|Drug|Interleukin-2|Biological response modifier in liquid form; dosage of drug will vary by study
16344173|NCT00311675|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in single-dose vials containing 90-mcg/mL A/H5N1 HA. Dosage is two 90 mcg doses administered intramuscularly separated by approximately 28 days.
16344174|NCT00311662|Drug|Tonabersat|Tablet 40mg daily for 12 weeks
16344175|NCT00311662|Drug|Placebo|Tablet once daily for 12 weeks
16344176|NCT00311649|Biological|Inactivated Influenza A Vaccine A/H5N1|
16344177|NCT00311636|Drug|cyclophosphamide|
16344178|NCT00311636|Drug|docetaxel|
16344179|NCT00311636|Drug|doxorubicin hydrochloride|
16344180|NCT00311636|Drug|epirubicin hydrochloride|
16344181|NCT00311636|Drug|fluorouracil|
16344182|NCT00311636|Drug|methotrexate|
16344183|NCT00311636|Drug|paclitaxel|
16344184|NCT00311636|Drug|triptorelin|
16344185|NCT00311636|Procedure|adjuvant therapy|
16344186|NCT00311623|Drug|Rapamycin 3mg|Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
16344187|NCT00311623|Drug|Rapamycin 6mg|Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
16344188|NCT00311623|Procedure|Radical prostatectomy|Radical prostatectomy performed on Day 15
16344189|NCT00311610|Drug|SN-38 liposome|38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression
16344190|NCT00311597|Procedure|Radiosurgery|single fractionated radiation therapy
16344191|NCT00311584|Drug|irinotecan hydrochloride|Given IV
16344192|NCT00311584|Drug|temozolomide|Given IV
16344193|NCT00311571|Drug|Ethidronate|
16344194|NCT00311571|Behavioral|Physical training|
16344195|NCT00311558|Biological|recombinant interferon alfa-2b|SSG x 5 week
16344196|NCT00311558|Drug|sodium stibogluconate|SSG & IFN
16344197|NCT00311558|Drug|SSG & interferon|1 arm study with SSG & interferon
16344198|NCT00311545|Biological|CNTO 328|Anti-IL-6 chimeric monoclonal antibody
16344199|NCT00311519|Drug|Hylenex|
16344200|NCT00311493|Biological|Tick-Borne Encephalitis vaccine|
16344201|NCT00311480|Biological|Influenza vaccine surface antigen adjuvanted with MF59|
16344202|NCT00311467|Drug|Capecitabine, Interferon, Interleukin|"Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
~Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
~Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
~Group B
~Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
~Efficacy evaluations will be performed every 14 weeks of treatment in both groups"
16344203|NCT00311454|Drug|T.R.U.E.Test|
16344204|NCT00311441|Biological|Tick-Borne Encephalitis vaccine|
16344205|NCT00311428|Biological|Influenza|
16344206|NCT00311415|Biological|Meningococcal C conjugate vaccine|"Meningococcal conjugate vaccine, active comparator.
~Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age"
16344207|NCT00311402|Drug|Aggrenox capsule|extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
16344208|NCT00311402|Other|Acetylsalicylic Acid (ASA)|Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
16344209|NCT00311389|Drug|Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16344210|NCT00311389|Drug|Latanoprost 0.005%/Timolol 0.005% ophthalmic solution|Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16344211|NCT00311376|Biological|botulinum toxin Type A (200U)|botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
16344212|NCT00311376|Biological|botulinum toxin Type A (300U)|botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval
16344213|NCT00311376|Other|Normal Saline (Placebo); botulinum toxin Type A (200U)|Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
16344214|NCT00311376|Other|Normal Saline (Placebo); botulinum toxin Type A (300U)|Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
16344215|NCT00311363|Drug|GEn (XP13512)|1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks
16344216|NCT00311363|Drug|GEn (XP13512)|1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks
16344217|NCT00311363|Drug|Placebo|Placebo, orally, once daily for 12 weeks following single blind 24-week phase
16344218|NCT00311350|Drug|MOA-728|
16344219|NCT00311337|Drug|bortezomib|
16344220|NCT00311324|Behavioral|Special Intervention|
16344221|NCT00311324|Behavioral|Delayed Intervention|
16344222|NCT00311311|Drug|tacrolimus|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
16344223|NCT00311311|Drug|mycophenolate mofetil|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
16344224|NCT00311311|Drug|prednisone|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
16344225|NCT00311311|Drug|sirolimus|"The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.
~On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant."
16344226|NCT00311311|Drug|tacrolimus|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
16344227|NCT00311311|Drug|mycophenolate mofetil|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
16344316|NCT00310557|Drug|Gadopentetate dimeglumine (Magnevist)|Approximately 0.1mmol/kg body weight, single intravenous administration on the study day
16344458|NCT00309751|Drug|Pitavastatin|Pitavastatin 4 mg QD
16344228|NCT00311311|Drug|prednisone|The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
16344229|NCT00311298|Dietary Supplement|Multimicronutrients|Randomised, double-blind trial among pulmonary TB patients, except those who are found to be sputum positive and HIV positive. Both arms received a daily biscuit weighing 30 g (4.5 g protein, 615 kJ). The biscuit given to the No micronutrient-arm contained no additional micronutrients. The biscuit given to the Micronutrient-arm contained the following micronutrients: vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg. The intervention was given for 60 days during initial TB treatment.
16344230|NCT00311298|Dietary Supplement|Energy and proteins|Randomised, single-blind trial among sputum-positive HIV-coinfected pulmonary TB patients. Both arms received a daily for biscuit weighing 30 g (4.5 g protein, 615 kJ), with micronutrients (vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg). The experimental arm received an additional 5 biscuits without additional micronutrients. Thus, both arms received the same amount of micronutrients. However, the intervention arm received 3690 kJ and 27 g protein per day, while the control arm received 615 kJ and 4.5 g protein. The intervention was given for 60 days during initial TB treatment.
16344231|NCT00311285|Device|Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry|
16344232|NCT00311272|Biological|MelCancerVac|
16344233|NCT00311259|Drug|Melatonin (drug)|
16344234|NCT00311259|Drug|Laktose|
16344235|NCT00311246|Drug|Adalimumab|Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.
16344236|NCT00311220|Drug|tuberculin for skin test|
16344237|NCT00311194|Behavioral|6 months readmission rate to hospital|
16344238|NCT00311181|Device|Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)|Patients that are indicated for an ICD or CRT-D receive one of these devices.
16344239|NCT00311168|Device|Intervention/treatment|"Device: VIP On
~Device: VIP Off"
16344240|NCT00311155|Drug|olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary|Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
16344241|NCT00311129|Drug|Fludarabine Phosphate (Fludara)|Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
16344242|NCT00311129|Drug|Rituximab|Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
16344243|NCT00311116|Drug|Vitamin E|
16344244|NCT00311103|Procedure|Specific clinical care program|The rheumatologists acted as principal care providers in regular visits, home visits and phone contacts. The visits were structured following specific proceedings for the different diagnoses based on previously demonstrated approaches. Such protocols included education and promotion of independence, pharmacological and no pharmacological treatment, and timing of diagnostic tests in a stepwise manner. The program also incorporated administrative duties such as the prescription of medication for the patients. Patients were seen as often as necessary according to the medical rheumatologist decision (until the episode of disability was medically resolved).
16344245|NCT00311090|Drug|Idrabiotaparinux sodium|"0.5 mL pre-filled syringe for 3.0 mg
~Subcutaneous injection"
16344246|NCT00311090|Drug|Idraparinux sodium|"0.5 mL pre-filled syringe for 2.5 mg
~Subcutaneous injection"
16344247|NCT00311090|Drug|Avidin|"100 mg in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
16344248|NCT00311090|Drug|Placebo (for Avidin)|"Avidin matching powder in 10 mg/mL solution
~Intravenous infusion for 30 minutes"
16344249|NCT00311077|Drug|Insulin Glulisine|
16344250|NCT00311064|Behavioral|physical activity|
16344251|NCT00311051|Drug|ramatroban|
16344252|NCT00311051|Drug|montelukast|
16344253|NCT00311038|Drug|ONO-1101|
16344254|NCT00311025|Procedure|intensive endurance, strength and balance exercises|
16344255|NCT00311012|Drug|Aliskiren|
16344256|NCT00310999|Device|Shikani Optical Stylet|
16344257|NCT00310986|Behavioral|Breathing Meditation|
16344258|NCT00310973|Behavioral|Social Network Intervention|
16344259|NCT00310934|Drug|methadone|
16344260|NCT00310934|Drug|buprenorphine / methadone sequence|
16344261|NCT00310934|Behavioral|Relapse prevention|
16344262|NCT00310934|Behavioral|Contingency management|
16344263|NCT00310921|Drug|Misoprostol|
16344264|NCT00310908|Drug|Tramadol Hcl|Active Comparator
16344265|NCT00310895|Drug|Imetelstat Sodium (GRN163L)|Dose increase by 25% if tolerated infused over 2 hours
16344385|NCT00310115|Behavioral|Smoking Prevention Usual Care|Usual care of self-help materials and advice for staying cigarette free
16344459|NCT00309751|Drug|Atorvastatin|Atorvastatin 20 mg
16344266|NCT00310869|Behavioral|Individualized Developmental Care in the NICU|Newborn Individualized Developmental Care and Assessment Program (NIDCAP) utilizes close observation of each infant's thresholds of moving from organization to disorganization and stress, as exhibited by the infant's behavior. Care and environment are then continuously and dynamically adjusted to increase the infant's self-regulation and organization and decrease the infant's stress. This individualized model of NICU care provides an opportunity to investigate the modifiability of very early born infants' brain function and structure and the possibility of reducing or altogether eliminating the disruption and disturbance of fetal brain development in the NICU.
16344267|NCT00310856|Biological|MenACWY-CRM|Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
16344268|NCT00310856|Biological|MenC-CRM|One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
16344269|NCT00310856|Biological|DTaP-Hib-IPV|
16344270|NCT00310856|Biological|PC7|One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
16344271|NCT00310856|Biological|MMR|
16344272|NCT00310856|Biological|Varicella|
16344273|NCT00310843|Drug|Nevirapine|Patients with HIV-1 infection who have taken or are currently taking nevirapine
16344274|NCT00310830|Drug|Bosentan|Oral, Initial dose: 62.5 mg b.i.d. for 4 weeks, maintenance dose: 125 mg b.i.d.
16344275|NCT00310817|Biological|MenACWY-CRM conjugate vaccine, adjuvanted|
16344276|NCT00310817|Biological|MenACWY polysaccharide vaccine|
16344277|NCT00310817|Biological|MenACWY-CRM conjugate vaccine, unadjuvanted|
16344278|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
16344279|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
16344280|NCT00310804|Biological|Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)|One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
16344281|NCT00310804|Biological|Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)|One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
16344282|NCT00310791|Drug|Hormone replacement therapy (estrogen/progestin)|Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
16344283|NCT00310791|Other|Placebo (Sugar Pill)|Placebo (sugar pill)
16344284|NCT00310791|Drug|Dehydroepiandrosterone (DHEA)|50 mg tablet, 1 daily
16344285|NCT00310778|Drug|high sodium diet|high sodium diet
16344286|NCT00310778|Drug|low sodium diet|low sodium diet
16344287|NCT00310778|Drug|ramipril 10 mg|ramipril 10 mg
16344288|NCT00310778|Drug|valsartan 160 mg|valsartan 160 mg
16344289|NCT00310778|Drug|candesartan 8 mg|candesartan 8 mg
16344290|NCT00310778|Drug|atenolol 50 mg|atenolol 50 mg
16344291|NCT00310765|Drug|Pregabalin|First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days
16344292|NCT00310765|Drug|Pregabalin|75 mg po BID
16344293|NCT00310752|Device|DermaStream(tm) application and Streaming of Saline|
16344294|NCT00310726|Other|abrupt weaning at 4 months|abrupt weaning at 4 months
16344295|NCT00310726|Other|Continued exclusive breastfeeding|Continued exclusive breastfeeding
16344296|NCT00310713|Biological|Meningococcal C conjugate vaccine|Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
16344297|NCT00310700|Biological|Meningococcal C conjugate vaccine|
16344298|NCT00310687|Procedure|BLOOD DRAW|
16344299|NCT00310674|Biological|Meningococcal C Conjugate Vaccine|
16344300|NCT00310661|Drug|Sarizotan|The dose of sariztan HCI for each patient in the drug arm will be given 2mg b.i.d. orally during the first 4 weeks of treatment. If efficacy is inadequate and there are no safety concerns, the option to raise the dose to 5mg b.i.d is given. After 8 weeks of treatment, the option to raise the dose to 7mg bid is given. Dose may remain the same or may be decreased again to the previous dose.
16344301|NCT00310661|Other|Placebo|Placebo for each patient randomized to the placebo arm will be given placebo (oral, twice daily) in a pill form for 12 weeks
16344302|NCT00310648|Biological|Influenza vaccine|
16344303|NCT00310635|Biological|Meningococcal C conjugate vaccine|
16344304|NCT00310622|Device|HyperQ Signal recording|
16344305|NCT00310609|Drug|Gadopentetate dimeglumine (Magnevist)|Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
16344306|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|0,1mmol/kg at 10 mL/15 sec
16344307|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|same dose as arm 1 at bolus rate (2mL/sec)
16344308|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|0,3mmol/kg at 10 mL/15 sec
16344309|NCT00310596|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|same dose as arm 3 at bolus rate (2mL/sec)
16344310|NCT00310596|Drug|Moxifloxacin (BAY12-8039)|400 mg at 0,07 mL/sec over 60 min
16344311|NCT00310596|Drug|Placebo|0,9% saline at 0,6mL/kg at bolus rate
16344312|NCT00310583|Drug|Pregabalin|
16344313|NCT00310570|Device|Circumferential thermoplastic thimble splint|
16344314|NCT00310570|Device|"dorsal aluminium foam Mexican Hat splint"|
16344315|NCT00310570|Device|stack splint (control)|
16344386|NCT00310115|Behavioral|Counseling Intervention|6 x 30 minute counseling sessions over the telephone
16344317|NCT00310544|Drug|Magnevist (Gadopentetate dimeglumine, BAY86-4882)|One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
16344318|NCT00310544|Drug|Magnevist (Gadopentetate dimeglumine, BAY86-4882)|One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight
16344319|NCT00310531|Drug|Menostar (Estradiol, BAY86-5435)|Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
16344320|NCT00310531|Drug|Raloxifene|Raloxifene tbl. (60 mg/day)
16344321|NCT00310518|Drug|ARQ 501|
16344322|NCT00310505|Drug|Amphotericin B deoxycholate given as daily administration|
16344323|NCT00310492|Biological|subcutaneous immunotherapy|Updosing by 16 injections to 100,000 SQ-U
16344324|NCT00310479|Device|Magnetic Resonance Spectroscopy (3Tesla)|
16344325|NCT00310466|Biological|Sublingual immunotherapy|once daily intake of sublingual drops
16344326|NCT00310466|Biological|Placebo|once daily intake of sublingual drops
16344327|NCT00310453|Biological|ALK Grass tablet|
16344328|NCT00310440|Device|P-15 Synthetic osteoconductive bone substitute|Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
16344329|NCT00310440|Other|Autologous bone|Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
16344330|NCT00310427|Drug|LY686017|50 mg administered orally on a daily basis
16344331|NCT00310427|Drug|Placebo|Administered on a daily basis
16344332|NCT00310401|Drug|Albuterol|5 mg nebulized q4h
16344333|NCT00310401|Drug|Saline|1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
16344334|NCT00310388|Drug|Retigabine (INN), Ezogabine (USAN)|Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
16344335|NCT00310375|Drug|Ezogabine: USAN Retigabine (International Nonproprietary Name)|Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
16344336|NCT00310362|Behavioral|Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures|Interactive voice response system (IVR) calls patients 7 or 3 days prior to their appointment. Information available in the IVR system is based on the same template nurses use in usual care and includes an appointment reminder, preparation instructions, basic information about the procedure, and answers to commonly asked questions.
16344337|NCT00310349|Biological|23 valent pneumococcal polysaccharide vaccine|
16344338|NCT00310336|Drug|S-adenosyl-L-methionine|
16344339|NCT00310336|Drug|betaine|
16344340|NCT00310336|Drug|pegylated interferon alpha2b|
16344341|NCT00310336|Drug|ribavirin|
16344342|NCT00310323|Drug|Dextromethorphan|0.5 mg/kg (maximum 30 mg)
16344343|NCT00310323|Drug|Caffeine|Administered as 4 ounces of Coca-Cola
16344344|NCT00310310|Behavioral|Sleep Apnea Self-Management Program|Sleep apnea self-management program - 4 sessions, group-based.
16344345|NCT00310310|Behavioral|Usual care|Usual sleep apnea and cpap care
16344346|NCT00310297|Drug|Insulin Glulisine|
16344347|NCT00310284|Behavioral|Computerized delivery of cognitive-behavioral treatment of insomnia|
16344348|NCT00310284|Behavioral|Self-help manual to improve insomnia symptoms|
16344349|NCT00310271|Biological|pPJV7630 with pPJV2012 administered by PMED|
16344350|NCT00310258|Behavioral|Drug use prevention intervention|
16344351|NCT00310245|Procedure|STI (structured Treatment Interruption)|
16344352|NCT00310232|Drug|Epoetin Alfa|
16344353|NCT00310219|Procedure|computed tomography|
16344354|NCT00310219|Procedure|positron emission tomography|
16344355|NCT00310206|Biological|Inactivated Influenza A Vaccine A/H5N1|Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
16344356|NCT00310206|Biological|Inactivated Influenza A Vaccine A/H5N1|Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
16344357|NCT00310180|Drug|Anastrozole|Given PO
16344358|NCT00310180|Drug|Exemestane|Given PO
16344359|NCT00310180|Other|Laboratory Biomarker Analysis|Correlative studies
16344360|NCT00310180|Drug|Letrozole|Given PO
16344361|NCT00310180|Other|Quality-of-Life Assessment|Ancillary studies
16344362|NCT00310180|Radiation|Radiation Therapy|Undergo radiation therapy or partial breast irradiation
16344363|NCT00310180|Drug|Tamoxifen Citrate|Given PO
16344364|NCT00310167|Radiation|radiation therapy|
16344365|NCT00310154|Drug|docetaxel|
16344366|NCT00310154|Drug|gefitinib|
16344367|NCT00310154|Other|laboratory biomarker analysis|
16344368|NCT00310154|Radiation|radiation therapy|
16344369|NCT00310141|Behavioral|Smoking cessation intervention|6 weeks of computer delivered treatment for quitting smoking
16344370|NCT00310141|Other|Counseling intervention|In-person counseling (5 sessions)
16344371|NCT00310141|Drug|Nicotine patch|6-week supply of the nicotine patch
16344372|NCT00310128|Drug|cisplatin|
16344373|NCT00310128|Drug|cytarabine|
16344374|NCT00310128|Drug|etoposide|
16344375|NCT00310128|Drug|methylprednisolone|
16344376|NCT00310128|Drug|rituximab|
16344377|NCT00310128|Drug|yttrium Y 90 ibritumomab tiuxetan|
16344378|NCT00310128|Procedure|antibody therapy|
16344379|NCT00310128|Procedure|biological therapy|
16344380|NCT00310128|Procedure|chemotherapy|
16344381|NCT00310128|Procedure|monoclonal antibody therapy|
16344382|NCT00310128|Procedure|radiation therapy|
16344383|NCT00310128|Procedure|radioimmunotherapy|
16344384|NCT00310128|Procedure|radioisotope therapy|
16344456|NCT00309777|Drug|Simvastatin|Simvastatin once daily
16344387|NCT00310115|Behavioral|Counseling Intervention|2 in-person counseling sessions
16344388|NCT00310089|Biological|filgrastim|
16344389|NCT00310089|Biological|pegfilgrastim|
16344390|NCT00310089|Drug|cediranib maleate|
16344391|NCT00310089|Drug|cyclophosphamide|
16344392|NCT00310089|Drug|docetaxel|
16344393|NCT00310089|Drug|doxorubicin hydrochloride|
16344394|NCT00310089|Other|laboratory biomarker analysis|
16344395|NCT00310089|Procedure|conventional surgery|
16344396|NCT00310089|Procedure|neoadjuvant therapy|
16344397|NCT00310076|Drug|thalidomide|Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
16344398|NCT00310076|Procedure|surgery|Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
16344399|NCT00310063|Procedure|acupressure therapy|Acupressure wristband
16344400|NCT00310063|Procedure|sham intervention|Sham wristband
16344401|NCT00310050|Drug|pemetrexed disodium|500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).
16344402|NCT00310050|Device|Radiotherapy|During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
16344403|NCT00310037|Drug|bortezomib|Given IV
16344404|NCT00310024|Drug|bortezomib|Given IV
16344405|NCT00310024|Drug|vorinostat|Given orally
16344406|NCT00310024|Other|laboratory biomarker analysis|Correlative studies
16344407|NCT00310024|Other|pharmacological study|Correlative studies
16344408|NCT00310011|Drug|cisplatin|
16344409|NCT00310011|Drug|gemcitabine hydrochloride|
16344410|NCT00310011|Drug|paclitaxel|
16344411|NCT00310011|Procedure|conventional surgery|
16344412|NCT00309998|Biological|bevacizumab|
16344413|NCT00309998|Drug|vinorelbine tartrate|
16344414|NCT00309985|Drug|androgen-deprivation therapy|LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
16344415|NCT00309985|Drug|docetaxel|Given IV
16344416|NCT00309972|Drug|Control arm (SEQ):|Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
16344417|NCT00309972|Drug|Experimental arm (CON):|concurrent chemo-radiotherapy [55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20] followed by two cycles of cisplatinum/vinorelbine.
16344418|NCT00309959|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16344419|NCT00309959|Other|Laboratory Biomarker Analysis|Correlative studies
16344420|NCT00309946|Drug|cediranib maleate|Given orally
16344421|NCT00309933|Procedure|cognitive assessment|
16344422|NCT00309933|Procedure|psychosocial assessment and care|
16344423|NCT00309933|Procedure|quality-of-life assessment|
16344424|NCT00309920|Biological|darbepoetin alfa|
16344425|NCT00309920|Drug|cyclophosphamide|
16344426|NCT00309920|Drug|docetaxel|
16344427|NCT00309920|Drug|doxorubicin hydrochloride|
16344428|NCT00309920|Drug|epirubicin hydrochloride|
16344429|NCT00309920|Drug|fluorouracil|
16344430|NCT00309907|Biological|etanercept|Given IV and subcutaneously
16344431|NCT00309907|Drug|methylprednisolone|Given IV and orally
16344432|NCT00309894|Biological|sargramostim|
16344433|NCT00309894|Drug|ketoconazole|
16344434|NCT00309894|Drug|therapeutic hydrocortisone|
16344435|NCT00309881|Biological|rituximab|
16344436|NCT00309881|Drug|cyclophosphamide|
16344437|NCT00309881|Drug|doxorubicin hydrochloride|
16344438|NCT00309881|Drug|prednisone|
16344439|NCT00309881|Drug|vincristine sulfate|
16344440|NCT00309868|Drug|neseritide|
16344441|NCT00309855|Drug|Placebo|im and orally
16344442|NCT00309855|Drug|Testosterone|injections
16344443|NCT00309855|Drug|Anastrazole|orally x 21 days
16344444|NCT00309855|Drug|Dutasteride|orally x 21 days
16344445|NCT00309842|Biological|filgrastim|All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days.
16344446|NCT00309842|Drug|cyclophosphamide|Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW > 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.
16344447|NCT00309842|Drug|cyclosporine|Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of > 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
16344448|NCT00309842|Drug|fludarabine phosphate|Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);
16344449|NCT00309842|Drug|mycophenolate mofetil|"All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours).
~Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day."
16344450|NCT00309842|Procedure|umbilical cord blood transplantation|The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
16344451|NCT00309842|Radiation|total-body irradiation|The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).
16344452|NCT00309816|Drug|sildenafil|
16344453|NCT00309803|Device|FiberNet Embolic Protection Device|
16344454|NCT00309790|Drug|sildenafil|
16344455|NCT00309777|Drug|Pitavastatin|Pitavastatin once daily
16344463|NCT00309712|Drug|fenofibrate 160 mg and placebo|
16344464|NCT00309712|Drug|simvastatin 20 mg and placebo|
16344465|NCT00309712|Drug|fenofibrate 160 mg and simvastatin 20 mg|
16344466|NCT00309699|Drug|Placebo|Daily for 3 weeks
16344467|NCT00309699|Drug|Quetiapine|400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
16344468|NCT00309699|Drug|Paliperidone ER|3 to 12 mg daily, flexibly dosed, for 12 weeks
16344469|NCT00309686|Drug|Paliperidone ER|
16344470|NCT00309673|Drug|lidocaine / Prilocaine|
16344471|NCT00309660|Drug|Rosiglitazone|
16344472|NCT00309647|Biological|Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine|2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
16344473|NCT00309647|Biological|Influenza Monovalent Whole virus (H5N1)|2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
16344474|NCT00309634|Biological|4 adjuvanted pandemic influenza candidate vaccines|
16344475|NCT00309634|Biological|4 non-adjuvanted pandemic influenza candidate vaccines|
16344476|NCT00309621|Drug|alitretinoin|
16344477|NCT00309608|Drug|Linagliptin|Linagliptin medium dose tablet once daily
16344478|NCT00309608|Drug|Linagliptin|Linagliptin high dose tablet once daily
16344479|NCT00309608|Drug|Linagliptin|Linagliptin low dose tablet once daily
16344480|NCT00309608|Drug|Placebo|Placebo tablets once daily
16344481|NCT00309608|Drug|Glimepiride|Glimepiride tablets once daily
16344482|NCT00309595|Device|stent|Cordis SMART™ Nitinol Stent System
16344483|NCT00309595|Device|balloon|balloon angioplasty
16344484|NCT00309569|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2
16344485|NCT00309569|Drug|Methotrexate|Methotrexate 40mg/m2
16344486|NCT00309569|Drug|Fluorouracil|Fluorouracil 600mg/m2
16344487|NCT00309569|Drug|Epirubicin|Epirubucin 60mg/m2 (only node-positive patients)
16344488|NCT00309569|Other|Surgery|Surgery
16344489|NCT00309556|Drug|Epirubicin|6 cycles 75mg/m2 i.v. day 1 q3w
16344490|NCT00309556|Drug|Docetaxel|6 cycles 75mg/m2 i.v. day 1 q3w
16344491|NCT00309556|Drug|Capecitabine|6 cycles 1000mg/m2 oral, day 1-14 q2d
16344492|NCT00309556|Drug|Trastuzumab|cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)
16344493|NCT00309543|Drug|Fluorouracil|
16344494|NCT00309543|Drug|Leucovorin|
16344495|NCT00309530|Drug|5-fluorouracil, levamisol, interferon|
16344496|NCT00309517|Drug|Fluourouracil|
16344497|NCT00309517|Drug|Leucovorin|
16344498|NCT00309517|Drug|MAb 17-1A|
16344499|NCT00309491|Drug|Tamoxifen alone|2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
16344500|NCT00309491|Drug|Tamoxifen + Aminoglutethimide|"2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years)
~1st therapy week:125mg/-/125mg Aminoglutethimide daily
~2nd therapy week: 125mg/-/250mg Aminoglutethimid daily
~as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily"
16344501|NCT00309478|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2
16344502|NCT00309478|Drug|Methotrexate|Methotrexate 40mg/m2
16344503|NCT00309478|Drug|Fluorouracil implant|Fluorouracil 600mg/m2
16344504|NCT00309478|Drug|Goserelin|Zoladex 3.6mg/28 days for 3 years
16344505|NCT00309478|Drug|Tamoxifen|Nolvadex 20mg/day for 5 years
16344506|NCT00309465|Drug|Lantus|Patients in Group 1 will administer 80% of their usual insulin glargine dose.
16344507|NCT00309465|Other|Insulin|Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
16344508|NCT00309465|Drug|Lantus|Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.
16344509|NCT00309452|Behavioral|Cognitive Behavioral Group Therapy|once per week
16344510|NCT00309452|Behavioral|Cognitive remediation|as needed
16344511|NCT00309452|Drug|Medications|Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
16344512|NCT00309452|Behavioral|MFG|Multi-Family psychoeducation Group based on the model published by McFarlane et al.
16344513|NCT00309452|Behavioral|Assertive case management|Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
16344514|NCT00309452|Other|Treatment as Usual in the community|Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
16344515|NCT00309439|Procedure|ALA-rich diet|
16344516|NCT00309413|Drug|Placebo/Cannabidiol|600 mg/day, oral, capsules, 2 weeks, than cross-over
16344517|NCT00309413|Drug|Cannabidiol/Placebo|600 mg/day, oral, capsules, 2 weeks, than cross-over
16344518|NCT00309387|Dietary Supplement|Centrum|Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).
16344519|NCT00309387|Other|Placebo|placebo tablets manufactured to mimic Centrum tablets.
16344520|NCT00309374|Drug|LPS 2ng/kg intravenous bolus|
16344521|NCT00309374|Drug|Simvastatin 80mg; administered daily p.o. over 5 days|
16344522|NCT00309374|Drug|Rosuvastatin 40mg; administered daily p.o. over 5 days|
16344523|NCT00309361|Drug|Phentolamine Mesylate (NV-101)|
16344524|NCT00309348|Other|Weekly measurement of graft flow|
16344525|NCT00309335|Drug|Phentolamine Mesylate (NV-101)|
16344526|NCT00309322|Drug|Phentolamine Mesylate (NV-101)|
16344527|NCT00309309|Drug|Rosiglitazone|
16344576|NCT00308802|Procedure|Kidney transplantation|Participants in this study will have had a kidney transplant
16344577|NCT00308789|Procedure|Biphasic Infant flow NCPAP|Biphasic Nasal continuous positive airway pressure
16344578|NCT00308789|Procedure|CPAP|Continuous positive airway pressure
16344623|NCT00308451|Drug|Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)|
16344528|NCT00309296|Behavioral|smoking cessation|This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
16344529|NCT00309283|Drug|Long-acting somatostatin|Patients randomized to treatment will be given intramuscularly long-acting somatostatin (Sandostatin-LAR, Novartis, Basel) at the dose of 40 mg every 28 days (in two intragluteal 20 mg injections).
16344530|NCT00309283|Other|Saline solution|Patients randomized to placebo will be given intramuscularly the same volume of solvent used to dissolve somatostatin every 28 days (in two intragluteal injections).
16344531|NCT00309270|Drug|Campath-1H|
16344532|NCT00309257|Drug|ACE I, ATA II and Statins|
16344533|NCT00309257|Drug|Benazepril, Valsartan and Fluvastatin|"Patients will be given a low dose of Benazepril, 10 mg/die,that, if tolerated, will be up-titrated, after a week,to 20 mg/day.
~Patients will be given Valsartan, 80 mg/die,up-titrated after a week to 160 mg/die. Fluvastatin will be started at 40 mg/die.If tolerated, will up-titrated to 80 mg/die. In case of liver, muscular or renal toxicity, fluvastatin will be back-titrated to 40 mg or withdrawn as deemed appropriate."
16344534|NCT00309244|Drug|Technosphere® Insulin Inhalation Powder|Inhalation, 15U/30U
16344535|NCT00309244|Drug|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)|BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
16344536|NCT00309231|Procedure|Islet Allotransplantation|Clinical islet transplantation using the Edmonton protocol, steroid free immunosuppression using sirolimus and tacrolimus and basilixumab induction therapy
16344537|NCT00309218|Drug|methylprednisolone|withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
16344538|NCT00309205|Drug|dapivirine (TMC120) vaginal gel|
16344539|NCT00309192|Drug|Triamcinolone Acetonide 4 mg intravitreal injection|
16344540|NCT00309192|Procedure|ETDRS grid laser technique|
16344541|NCT00309179|Drug|E7820 plus cetuximab|Escalating doses from 40 mg/m^2 irinotecan plus E7820 in combination with cetuximab.
16344542|NCT00309166|Biological|Cervarix vaccine|All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
16344543|NCT00309166|Biological|Engerix-B vaccine|All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
16344544|NCT00309140|Drug|enzastaurin|500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity
16344545|NCT00309127|Behavioral|Multidisciplinary team care|
16344546|NCT00309114|Procedure|bacterial interference|
16344547|NCT00309101|Drug|tacrolimus|Oral
16344548|NCT00309088|Drug|tacrolimus|oral
16344549|NCT00309088|Drug|placebo|oral
16344550|NCT00309075|Drug|Gadopentetate dimeglumine (Magnevist)|Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
16344551|NCT00309062|Biological|Recombinant birch pollen|
16344552|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
16344553|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral IV and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
16344554|NCT00309049|Drug|Ixabepilone|Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral oral and IV dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
16344555|NCT00309036|Biological|Recombinant grass pollen|
16344556|NCT00309023|Drug|BMS-663513|mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response
16344557|NCT00308997|Device|1-hertz Repetitive Transcranial Magnetic Stimulation|Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
16344558|NCT00308997|Device|Active 1-Hertz Repetitive transcranial magnetic stimulation|Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
16344559|NCT00308971|Drug|Alpha, gamma, beta, and delta (mixed) tocopherols|approximately 666 IU daily (1 pill) for 4 months
16344560|NCT00308971|Drug|alpha lipoic acid|600 mg daily (2 pills 300 mg each) for 4 months
16344561|NCT00308971|Drug|placebo|placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months
16344562|NCT00308971|Drug|placebo|placebo for alpha lipoic acid; 2 pills daily for 4 months
16344563|NCT00308958|Device|High frequency chest wall oscillator|
16344564|NCT00308945|Drug|travoprost 0.004% (drug)|local drop application
16344565|NCT00308945|Drug|latanoprost 0.005% (drug)|local drop application
16344566|NCT00308932|Drug|HFA FP MDI|
16344567|NCT00308919|Drug|WST09|Treatment with WST09 Vascular Photodynamic therapy
16344568|NCT00308906|Drug|aminoglycoside|Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.
16344569|NCT00308893|Genetic|Genetic analysis|Compare BDNF polymorphism among responders and non-responders
16344570|NCT00308880|Drug|Transamin|
16344571|NCT00308867|Procedure|Photodynamic Therapy|
16344572|NCT00308867|Procedure|Cryosurgery|
16344573|NCT00308854|Procedure|Photodynamic Therapy|
16344574|NCT00308841|Drug|Lidocaine (drug)|
16344575|NCT00308815|Device|Automatic CPR machine|
16344579|NCT00308776|Procedure|Cholecystokinin (CCK) infusion|Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK.
16344580|NCT00308776|Procedure|Saline infusion|Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only.
16344581|NCT00308763|Drug|Nicotine Patch|"After determining that it is appropriate to dispense study medication to a participant, the dosing regimen will be determined. Participants who report smoking more than 20 cigarettes each day will be initially placed on the 21 mg patch; participants who report smoking 10 - 19 cigarettes each day will be initially placed on the 14 mg patch; participants who report smoking 5 - 9 cigarettes will be initially placed on the 7 mg patch.
~If a participant is initially placed on the 21 mg patch, the following dosing schedule will occur: 21 mg patch for 4 weeks, 14 mg patch for 4 weeks, 7 mg patch for 2 weeks, and then off. If a participant is initially placed on the 14 mg patch, the following dosing schedule will occur: 14 mg patch for 6 weeks, 7 mg patch for 4 weeks, and then off. If a participant is initially placed on the 7 mg patch, the following dosing schedule will occur: 7 mg patch for 10 weeks, and then off."
16344582|NCT00308763|Drug|Sustained Release Bupropion|Participants will receive the sustained-release bupropion 150 mg tablet in the morning for four days. If this dose is well-tolerated, then the dose will be increased to a 150 mg tablet twice daily, with at least 8 hours between the two doses. The sustained-release bupropion medication will begin at the randomization visit (RV) which is approximately one week before the quit date. At the RV, the participant should be dispensed enough of the 150 mg tablets of the sustained-release bupropion or placebo to return for the first follow-up visit with instructions on use. Participants will be evaluated by telephone on their quit date approximately one week after the RV to assess safety. We will discontinue the sustained-release bupropion at the second follow-up visit, at which time participants will have received sustained-release bupropion for approximately 11 weeks.
16344583|NCT00308750|Drug|enzastaurin|1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression
16344584|NCT00308750|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease
16344585|NCT00308750|Drug|docetaxel|75 mg/m^2, IV, q 21 days, six 21 day cycles or progressive disease
16344586|NCT00308750|Drug|carboplatin|Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease
16344587|NCT00308737|Drug|Technosphere® Insulin Inhalation Powder|Inhalation, 15U/30U
16344588|NCT00308737|Drug|Usual Care|Subjects will receive antidiabetes treatment at the discretion of their physicians
16344589|NCT00308724|Behavioral|Cognitive Behavior Therapy|8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
16344590|NCT00308724|Behavioral|Telephone check-in|Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
16344591|NCT00308711|Drug|Misoprostol vaginal insert 100 mcg|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
16344592|NCT00308711|Drug|Misoprostol vaginal insert 50 mcg|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
16344593|NCT00308711|Drug|Dinoprostone vaginal insert (Cervidil)|Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
16344594|NCT00308685|Drug|Albuterol 90mcg|
16344595|NCT00308685|Drug|Placebo|Placebo
16344596|NCT00308659|Procedure|FOB protected distal microbiological samplings|
16344597|NCT00308620|Drug|chloroquine phosphate|250mg or 500mg PO (by mouth) QDay
16344598|NCT00308620|Drug|Placebo|Placebo once daily for 8 weeks
16344599|NCT00308607|Drug|Bevacizumab (Avastin)|
16344600|NCT00308607|Drug|dacarbazine|
16344601|NCT00308607|Drug|interferon-alfa-2a (Roferon-A)|
16344602|NCT00308594|Drug|Dexamethasone|
16344603|NCT00308581|Biological|Certolizumab pegol|400mg Certolizumab Pegol, Q4W, administered 4-weekly
16344604|NCT00308581|Biological|Certolizumab pegol|400mg Certolizumab Pegol, Q2W, administered 2-weekly
16344605|NCT00308581|Other|Placebo|placebo administered 4-weekly in Active 1
16344606|NCT00308568|Behavioral|Mailed educational brochure|
16344607|NCT00308555|Drug|Cannabis|
16344608|NCT00308542|Drug|dexamethasone|
16344609|NCT00308529|Drug|irinotecan|
16344610|NCT00308529|Drug|carboplatin|
16344611|NCT00308529|Drug|bevacizumab|
16344612|NCT00308529|Procedure|Radiation Therapy|
16344613|NCT00308516|Drug|5-Fluorouracil|"Combined Modality Treatment:
~fluorouracil 225mg/m2 IV continuous infusion days 1-42
~Systemic Treatment:
~5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15"
16344614|NCT00308516|Drug|Bevacizumab|"Combined Modality Treatment:
~bevacizumab 5mg/kg IV infusion days 1, 15, and 29
~Systemic Treatment:
~bevacizumab 5 mg/kg days 1 and 15"
16344615|NCT00308516|Procedure|Radiation Therapy|radiation 1.8 Gy/day or 28 fractions weeks 1-6
16344616|NCT00308516|Drug|Oxaliplatin|"Systemic Treatment:
~oxaliplatin 85 mg/m2 days 1 and 15"
16344617|NCT00308516|Drug|Leucovorin|"Systemic Treatment:
~leucovorin 350 mg prior to FU on days 1 and 15"
16344618|NCT00308503|Drug|eplivanserin (SR46349)|oral administration
16344619|NCT00308503|Drug|placebo|oral administration
16344620|NCT00308490|Drug|iron sucrose|
16344621|NCT00308477|Drug|dexamethasone|
16344622|NCT00308464|Drug|PHA-794428|
16356412|NCT00210327|Drug|Bortezomib (drug)|
16344624|NCT00308438|Drug|Teduglutide (ALX-0600)|0.1 mg/kg injected subcutaneously daily
16344625|NCT00308425|Drug|Enteric-coated Mycophenolate sodium (EC-MPS), valsartan|
16344626|NCT00308412|Biological|rHPIV3cp45|Placebo for rHPIV3cp45 vaccine is 1X L-15.
16344627|NCT00308412|Biological|Placebo|Placebo for rHPIV3cp45 vaccine
16344628|NCT00308399|Drug|Itopride|
16344629|NCT00308386|Behavioral|Nurse Case Management intervention|Intervention is meeting with nurse case managers
16344630|NCT00308373|Drug|Metformin vs Thiazolidinedione (Pioglitazone)|
16344631|NCT00308360|Drug|Risperidone, divalproex|
16344632|NCT00308347|Drug|MK0954, losartan / Duration of Treatment: mean 3.4 years|
16344633|NCT00308347|Drug|Placebo / Duration of Treatment: mean 3.4 years|
16344634|NCT00308334|Drug|Domperidone|10 mg po TID X 14 days
16344635|NCT00308334|Drug|Placebo- Sugar pill|placebo po TID x 14 days
16344636|NCT00308321|Drug|long term tapering of prednisolone|60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16)
16344637|NCT00308321|Drug|standard prednisolone treatment|60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8
16344638|NCT00308308|Drug|Technosphere Insulin|Inhalation, 15U/30U
16344639|NCT00308308|Drug|Active comparator|sc injectable insulin
16344640|NCT00308295|Drug|Fish oil capsules|
16344641|NCT00308295|Drug|matched placebo capsules|
16344642|NCT00308282|Drug|LY2127399|30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
16344643|NCT00308282|Drug|Placebo|IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
16344644|NCT00308269|Drug|Vintafolide IV Bolus|Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
16344645|NCT00308269|Drug|Vintafolide IV Infusion|Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
16344646|NCT00308256|Behavioral|nurse-counselling|Phone calls performed by nurse 15 days after each monthly visit
16344647|NCT00308243|Drug|Sodium Pyruvate in 0.9% Sodium Chloride Solution|
16344648|NCT00308230|Procedure|Six minute walk test|
16344649|NCT00308230|Behavioral|Minnesota Living with Heart Failure Questionnaire|
16344650|NCT00308204|Drug|Raptiva|injection
16344651|NCT00308191|Drug|Formoterol Fumarate|
16344652|NCT00308191|Drug|Tiotropium Bromide|
16344653|NCT00308178|Drug|Abraxane|Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks)
16344654|NCT00308165|Procedure|Convection-Enhanced Delivery|microinfusion pumps to deliver chemotherapy directly into brain tumors
16344655|NCT00308165|Drug|Topotecan|chemotherapeutic drug for the treatment of brain tumors
16344656|NCT00308152|Drug|Infusion of 1 litre of normal saline before colonoscopy|Prehydration with normal saline
16344657|NCT00308139|Drug|exenatide, long acting release|
16344658|NCT00308139|Drug|exenatide|
16344659|NCT00308126|Drug|Hydroxyethyl Starch 130/0.4 (Voluven)|
16344660|NCT00308113|Drug|Prednisone|Prednisone 0/75 mg/kg/day.
16344661|NCT00308113|Dietary Supplement|Coenzyme Q10|serum levels of greater or equal to 2.5 micrograms/mL.
16344662|NCT00308100|Drug|Hydroxyethylstarch 130/0.4|HES 130/0.4, administered intra- and perioperatively, max. daily dose: 33ml/kg BW; if needed, additionally albumin is administered (ratio crystalloid to colloid= 1:1)
16344663|NCT00308100|Drug|5% Albumin|5% albumin, administered intra- and perioperatively
16344664|NCT00308087|Drug|Sargramostim (Leukine)|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
16344665|NCT00308087|Drug|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
16344666|NCT00308074|Drug|Aripiprazole|open-label, flexible-dosing
16344667|NCT00308061|Biological|FMP1/AS02A|FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
16344668|NCT00308061|Biological|Imovax Rabies Vaccine|Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.
16344669|NCT00308048|Drug|Pegylated Interferon alfa 2b and ribavirin|
16344670|NCT00308022|Device|High Frequency Percussive Ventilation|
16344671|NCT00308009|Procedure|Vaginal Repair for prolapse, TVT procedure|"TVT at the time of Vaginal Repair
~TVT 3 months after Vaginal Repair"
16344672|NCT00308009|Procedure|TVT and Prolapse surgery|"TVT at the time of Prolapse surgery
~TVT 3 months after Prolapse Surgery"
16344673|NCT00307996|Drug|Coenzyme Q10 (drug)|
16344674|NCT00307970|Drug|HFA FP MDI|
16344675|NCT00307970|Device|conventional chamber/mask; anti-static chamber/mask|
16344676|NCT00307957|Device|Pillar Palatal Implants|
16344677|NCT00307944|Drug|Pantoprazole|
16344678|NCT00307931|Biological|Certolizumab pegol|"certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.
~Treatment duration: 12 weeks."
16344679|NCT00307918|Device|acupuncture|
16344680|NCT00307905|Drug|Traumeel S|homeopathic remedy
16344681|NCT00307905|Drug|Placebo remedy|identical size, shape and taste of treatment medication
16344682|NCT00307892|Drug|Traumeel S: intra-operative irrigation + oral ingestion|homeopathic remedy
16344683|NCT00307892|Drug|Placebo|placebo remedy
16344684|NCT00307879|Drug|Drug: G-CSF (Dong-A pharmaceutical, Seoul, Korea)|
16344685|NCT00307879|Procedure|collection of mobilized peripheral blood stem cells|
16344686|NCT00307879|Procedure|Intracoronary infusion of mobilized cells|
16344687|NCT00307866|Procedure|Resovist (BAY86-4884, SH U 555 A)|Single bolus injection, followed by MRI
16344743|NCT00307502|Drug|Lopinavir/ritonavir|tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
16356940|NCT00205686|Drug|DHEA|
16344688|NCT00307853|Drug|Traumeel S|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
16344689|NCT00307853|Other|Traumeel S|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
16344690|NCT00307853|Other|Placebo|All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
16344691|NCT00307840|Drug|paricalcitol|
16344692|NCT00307827|Drug|Visilizumab|Visilizumab administered intravenously once per day for two days
16344693|NCT00307814|Drug|Epoetin Alfa|
16344694|NCT00307801|Drug|Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|1 pill per day taken orally over 7 cycles of 28 pills per cycle
16344695|NCT00307801|Drug|Placebo|1 pill per day taken orally over 7 cycles of 28 pills per cycle
16344696|NCT00307788|Procedure|acupuncture|acupuncture
16344697|NCT00307775|Drug|oestradiol|
16344698|NCT00307762|Behavioral|intensified gait trainer|Intensity and type of rehabilitation after stroke. Gait trainér + or overground walking + other gait-oriented physioteharpy. The third group (control patients) received traditional (ordinary) physiotherapy witn o efforts to intensify it.
16344699|NCT00307749|Drug|Placebo|once daily for 24 weeks
16344700|NCT00307749|Drug|MCC-257|20mg, once daily for 24 weeks
16344701|NCT00307749|Drug|MCC-257|40mg, once daily for 24 weeks
16344702|NCT00307749|Drug|MCC-257|80mg, once daily for 24 weeks
16344703|NCT00307736|Drug|5-fluorouracil|Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.
16344704|NCT00307736|Drug|bevacizumab|Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.
16344705|NCT00307736|Drug|erlotinib|Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.
16344706|NCT00307736|Procedure|External beam radiation therapy (EBRT)|Given on days 1-5 and 8-12
16344707|NCT00307723|Drug|bevacizumab|Intravenously on days 1, 15 and 29 of the first cycle. Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
16344708|NCT00307723|Drug|5-Fluorouracil|Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
16344709|NCT00307723|Drug|Oxaliplatin|Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
16344710|NCT00307723|Drug|gemcitabine|Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
16344711|NCT00307723|Procedure|External Beam Radiation Therapy|Monday through Friday ending on day 38 of cycle 1
16344712|NCT00307710|Biological|Trivalent Baculovirus-expressed Influenza HA vaccine|Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.
16344713|NCT00307697|Procedure|receipt of copy of psychiatic assessment letter|
16344714|NCT00307684|Drug|double blind placebo|matching placebo tablets once daily for 4 weeks
16344715|NCT00307684|Drug|double blind PR OROS methylphenidate|18, 36, 54,72 or 90 mg/day once daily for 4 weeks
16344716|NCT00307684|Drug|open label PR OROS methylphenidate|Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)
16344717|NCT00307671|Drug|prednisone, methylprednisolone,cyclophosphamides|treatment conventional
16344718|NCT00307671|Drug|Cyclophosphamide, Azathioprine,prednisone,methylprednisolone|reduction dose
16344719|NCT00307671|Drug|Mycophenolate mofetil,methotrexate|in the treatment conventional and in the reduction dose
16344720|NCT00307658|Drug|Intravenous immunoglobulins (human immunoglobulins G)|
16344721|NCT00307645|Drug|Cyclophosphamide|
16344722|NCT00307645|Drug|Mycophenolate mofetil|
16344723|NCT00307645|Drug|Azathioprine|
16344724|NCT00307645|Drug|Prednisone (and methylprednisolone)|
16344725|NCT00307632|Drug|Norelgestromine (NLGM)/ethinyl estradiol (EE)|Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).
16344726|NCT00307619|Drug|topiramate|
16344727|NCT00307606|Drug|Solu-medrol 125 mg|
16344728|NCT00307593|Drug|Infliximab|Infliximab
16344729|NCT00307593|Drug|Rituximab|Rituximab
16344730|NCT00307580|Drug|Cathflo Activase (Alteplase)|
16344731|NCT00307567|Biological|Pneumococcal (vaccine)|
16344732|NCT00307554|Biological|Pneumococcal (vaccine)|
16344733|NCT00307541|Biological|Pneumococcal (vaccine)|
16344734|NCT00307528|Biological|Pneumococcal vaccine GSK513026|Two-dose intramuscular injection. Five different formulations, each administered to one Group
16344735|NCT00307528|Biological|Pneumovax 23™|Single dose intramuscular injection.
16344736|NCT00307515|Drug|Fibrin Sealant 2 (FS2)|FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
16344737|NCT00307515|Device|Oxidized Regenerated Cellulose (Surgicel)|Commercially available Surgicel used within label.
16344738|NCT00307502|Drug|Nevirapine|tablets 200 mg, 400 mg/day
16344739|NCT00307502|Drug|Efavirenz|tablets 600 mg, 600 mg/day
16344740|NCT00307502|Drug|Indinavir/ritonavir|"Indinavir: capsules 400 mg, 1600 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
16344741|NCT00307502|Drug|Nelfinavir|tablets 250 mg, 2500 mg/day
16344742|NCT00307502|Drug|Saquinavir/ritonavir|"Saquinavir: tablets 500 mg, 2000 mg/day
~Ritonavir: tablets 100 mg, 200 mg/day"
16344744|NCT00307502|Drug|Atazanavir|capsules 200 mg, 400 mg/day
16344745|NCT00307502|Drug|Atazanavir/ritonavir|"Atazanavir: capsules 150 mg, 300 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
16344746|NCT00307502|Drug|Fos-amprenavir/ritonavir|"Fos-amprenavir: capsules 700 mg, 1400 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
16344747|NCT00307502|Drug|Tipranavir/ ritonavir|"Tipranavir: tablets 250 mg, 1000 mg/day
~Ritonavir: capsules 100 mg, 400 mg/day"
16344748|NCT00307502|Drug|Darunavir/ritonavir|"Darunavir: tablets 300 mg, 1200 mg/day
~Ritonavir: capsules 100 mg, 200 mg/day"
16344749|NCT00307489|Drug|tenofovir DF|300 mg tablet, once daily (QD)
16344750|NCT00307489|Drug|emtricitabine /tenofovir DF|emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
16344751|NCT00307476|Device|Rusch Nasopharyngeal Airway|
16344752|NCT00307463|Procedure|strict volume control policy|strict volume control by UF and dietary salt restriction
16344753|NCT00307463|Procedure|antihypertensive drugs administration|continue antihypertensive medications
16344754|NCT00307450|Drug|Levetiracetam|up to 200 mg per day in two dosages per day.
16344755|NCT00307437|Drug|Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg|Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
16344756|NCT00307437|Drug|Ustekinumab (CNTO 1275) 45 mg|Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
16344757|NCT00307437|Drug|Ustekinumab (CNTO 1275) 90 mg|Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
16344758|NCT00307424|Device|AutoCPAP|
16344759|NCT00307424|Device|FixCPAP|
16344760|NCT00307411|Drug|Growth hormone|
16344761|NCT00307398|Drug|Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg|One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.
16344762|NCT00307398|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.
16344763|NCT00307333|Device|HeRO heart rate characteristics monitor|24 hour continuous HRC monitoring with display
16344764|NCT00307320|Behavioral|Relaxation Training|Relaxation techniques training
16344765|NCT00307307|Drug|Niacin/simvastatin compared to simvastatin alone at 2 doses|
16344766|NCT00307294|Drug|Thalidomide|100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg
16344767|NCT00307294|Drug|Doxil|On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
16344768|NCT00307255|Drug|gemcitabine hydrochloride|1000 mg/m2 on days 1 and 8 of each 21 day cycle
16344769|NCT00307255|Drug|paclitaxel albumin-stabilized nanoparticle formulation|260 mg/m2 to 340 mg/m2 (dose will depend on when subject enters the study). Paclitaxel will be given on day 1 of each 21 day cycle (every 3 weeks)
16344770|NCT00307242|Drug|Adefovir Dipivoxil|
16344771|NCT00307229|Biological|adenoviral vector encoding rat Her-2/neu|Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)
16344772|NCT00307216|Behavioral|Graduated Recovery Intervention Program (GRIP)|GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.
16344773|NCT00307216|Behavioral|Treatment as usual (TAU)|Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
16344774|NCT00307203|Drug|bupropion SR|Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
16344775|NCT00307203|Behavioral|Cognitive Behavioral Group Therapy|Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
16344776|NCT00307203|Drug|nicotine replacement therapy|Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
16344777|NCT00307177|Biological|Trivalent inactivated influenza vaccine|Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0.
16344778|NCT00307177|Biological|Trivalent Baculovirus-expressed Influenza HA vaccine|Trivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0.
16344779|NCT00307164|Drug|NucleomaxX|36 g sachet taken orally three times daily
16344780|NCT00307164|Drug|NucleomaxX placebo|36 g placebo sachet taken orally three times daily
16344781|NCT00307151|Drug|Lamivudine|4 mg/kg twice daily
16344782|NCT00307151|Drug|Lopinavir/ritonavir|16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg
16344783|NCT00307151|Drug|Nevirapine|Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m^2/dose to max 200 mg twice daily
16344784|NCT00307151|Drug|Zidovudine|180 mg/m^2 twice daily
16344785|NCT00307138|Drug|hetastarch|
16344786|NCT00307125|Drug|Rituximab plus immunosuppression|"Genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously. Generally used in the treatment of non-Hodgkin's lymphoma
~Standard immunosuppression is site-specific."
16344787|NCT00307125|Drug|Placebo plus immunosuppression|"Placebo dosing: Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).
~Standard immunosuppression is site-specific."
16344788|NCT00307099|Drug|Meropenem|Meropenem 1 gram intravenously every 8 hours for 3 days (9 doses), then an additional 5 days if the Clinical Pulmonary Infection Score is greater than 6.
16344789|NCT00307099|Drug|Standard antibiotic therapy|Standard intravenous antibiotic therapy for a minimum of 8 days.
16344790|NCT00307086|Drug|Bortezomib|the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant
16344791|NCT00307086|Drug|Melphalan|Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes
16344792|NCT00307086|Procedure|PBSCT|PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)
16344793|NCT00307073|Device|Implantable Pulse Generator|
16344794|NCT00307060|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks|
16344795|NCT00307060|Drug|losartan / Duration of Treatment: 6 weeks|
16344796|NCT00307047|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16344797|NCT00307047|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16344798|NCT00307034|Biological|GSK Biologicals' 10-valent pneumococcal conjugate vaccine.|Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).
16344799|NCT00307034|Biological|Infanrix hexa.|Intramuscular injection, 3 doses (2-4-11 months of age schedule).
16344800|NCT00307034|Biological|Infanrix-IPV/Hib.|Intramuscular injection, 3 doses (2-4-11 months of age schedule).
16344801|NCT00307021|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|3-dose intramuscular injection, 2 different formulations
16344802|NCT00307008|Biological|Pneumovax 23™|Single dose intramuscular injection
16344803|NCT00306995|Biological|SB218352_15|Non-adjuvanted pandemic influenza A formulation 1 vaccine
16344804|NCT00306995|Biological|SB218352_8|Non-adjuvanted pandemic influenza A formulation 2 vaccine
16344805|NCT00306995|Biological|SB218352_4|Non-adjuvanted pandemic influenza A formulation 3 vaccine
16344806|NCT00306995|Biological|SB218352_2|Non-adjuvanted pandemic influenza A formulation 4 vaccine
16344807|NCT00306995|Biological|SB218352_8AL|Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
16344808|NCT00306995|Biological|SB218352_4AL|Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
16344809|NCT00306995|Biological|SB218352_2AL|Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
16344810|NCT00306982|Biological|Fluarix|
16344811|NCT00306969|Drug|bexarotene|
16344812|NCT00306969|Device|photopheresis|
16344813|NCT00306956|Behavioral|offer a pacifier|To offer a pacifier to normal newborn infants at 15 days of age
16344814|NCT00306943|Biological|Influsplit SSW®|
16344815|NCT00306930|Device|Acetabular cup|Acetabular cup replacement
16344816|NCT00306917|Device|non-coated femoral hip stem|total hip replacement
16344817|NCT00306917|Device|coated femoral hip stem|total hip replacement
16344818|NCT00306904|Drug|bevasiranib|
16344819|NCT00306891|Drug|Cediranib|45 mg oral dose
16344820|NCT00306891|Drug|Cediranib 30 - 90 mg|oral tablet dose escalation
16344821|NCT00306878|Drug|Abatacept|
16344822|NCT00306852|Procedure|Baerveldt implant|Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
16344823|NCT00306852|Procedure|Trabeculectomy with mitomycin C|Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant
16344824|NCT00306839|Procedure|standardized Lichtenstein technique|
16344825|NCT00306826|Drug|pioglitazone|
16344826|NCT00306826|Drug|simvastatin|
16344827|NCT00306826|Drug|pioglitazone + simvastatin|
16344828|NCT00306813|Drug|Revlimid|
16344829|NCT00306800|Procedure|Photodynamic therapy with methyl aminolevulinate cream|
16344830|NCT00306787|Drug|Famciclovir|Famciclovir 500 mg tablet
16344831|NCT00306787|Drug|Valacyclovir|Valacyclovir 500 mg capsule
16344832|NCT00306787|Drug|Placebo matching famciclovir|Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
16344833|NCT00306787|Drug|Placebo matching valacyclovir|Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
16344834|NCT00306774|Dietary Supplement|Vitamin D (cholecalciferol)|2,000 IU vitamin D capsule per day for 2 years
16344835|NCT00306774|Dietary Supplement|Placebo|Placebo capsule per day for 2 years
16344836|NCT00306761|Device|Dynamic Wheelchair Seating System|
16344837|NCT00306748|Drug|MD-1100 Acetate|
16344838|NCT00306735|Drug|Palonosetron|
16344839|NCT00306722|Drug|AQUAVAN® (fospropofol disodium) Injection|
16344840|NCT00306709|Behavioral|culturally adapted behavior change|Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.
16344841|NCT00306696|Drug|Rosiglitazone|
16344842|NCT00306696|Drug|spironolactone|
16344843|NCT00306696|Drug|hydrochlorothiazide|
16344844|NCT00306696|Drug|frusemide|
16344845|NCT00306683|Drug|DIAZOXIDE|
16344846|NCT00306670|Drug|Rituxan|Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies
16344847|NCT00306670|Drug|prednisone|<30 mg/day
16344848|NCT00306657|Procedure|Optic nerve sheath fenestration|
16344849|NCT00306644|Drug|Rosiglitazone|study drug
16344893|NCT00306189|Drug|100 mg AMG 162|100 mg AMG 162 (denosumab) SC every 6 months
16344850|NCT00306631|Drug|MKC-1|Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle
16344851|NCT00306618|Drug|Panzem Nanocrystal Colloidal Dispersion|Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
16344852|NCT00306605|Behavioral|Questionnaire|Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
16344853|NCT00306592|Biological|BG00002 (natalizumab)|
16344854|NCT00306566|Biological|CYT004-MelQbG10|
16344855|NCT00306553|Biological|CYT004-MelQbG10|
16344856|NCT00306540|Drug|Quetiapine Fumarate|oral flexible dose
16344857|NCT00306540|Drug|quetiapine fumarate placebo|oral 0 mg
16344858|NCT00306527|Biological|Cell culture derived influenza vaccine|as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
16344859|NCT00306527|Biological|egg-derived influenza subunit vaccine|as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
16344860|NCT00306514|Biological|CYT004-MelQbG10|
16344861|NCT00306501|Procedure|Swallowing Training|Swallowing Training with press of button
16344862|NCT00306488|Drug|OT-551 antioxidant eye drop|0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.
16344863|NCT00306475|Drug|divalproex sodium ER|divalproex sodium ER1000 mg
16344864|NCT00306475|Drug|placebo|placebo identical in appearance to active comparator
16344865|NCT00306462|Drug|Magnesium sulfate|Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is < 6/hour.
16344866|NCT00306462|Drug|Oral Nifedipine or placebo|Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is < 6/hour.
16344867|NCT00306449|Behavioral|Small group seminar-based educational intervention|
16344868|NCT00306436|Procedure|comprehensive management|
16344869|NCT00306423|Procedure|Other: Exercise|exercise 3 times per week for 12 weeks
16344870|NCT00306410|Drug|colecalciferol|
16344871|NCT00306397|Drug|Rapamycin|Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
16344872|NCT00306384|Drug|Alogliptin|Alogliptin tablets.
16344873|NCT00306371|Device|1450nm diode laser|
16344874|NCT00306358|Drug|Vitamin B12 (Cyanocobalamin)|
16344875|NCT00306345|Behavioral|Outreach|
16344876|NCT00306332|Procedure|T-cell and B-cell depletion|
16344877|NCT00306319|Drug|moxifloxacin|
16344878|NCT00306306|Device|Reprieve Endovascular Temperature Therapy System|
16344879|NCT00306293|Drug|valacyclovir|valacyclovir
16344880|NCT00306280|Device|Phototherapy|
16344881|NCT00306267|Drug|epoetin alfa|
16344882|NCT00306254|Drug|PD 0348292|
16344883|NCT00306254|Drug|Enoxaparin|
16344884|NCT00306241|Biological|HPV-16/18 L1 VLP AS04|
16344885|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
16344886|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
16344887|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
16344888|NCT00306228|Procedure|Postfibrinolysis percutaneous coronary intervention|implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
16344889|NCT00306215|Drug|CCX282-B|CCX282-B or placebo capsules
16344890|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after end-of-treatment (EOT)."
16344891|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."
16344892|NCT00306202|Drug|Dasatinib|"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment > 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."
16344894|NCT00306189|Drug|60 mg AMG 162|60 mg AMG 162 (denosumab) SC every 6 months
16344895|NCT00306189|Drug|14 mg AMG 162|14 mg AMG 162 (denosumab) SC every 6 months
16344896|NCT00306189|Drug|Placebo|Placebo SC every 6 months
16344897|NCT00306176|Drug|Rosiglitazone|
16344898|NCT00306163|Drug|Ciclesonide|inhaled Ciclesonide 160 µg, once daily in the morning
16344899|NCT00306163|Drug|Fluticasone|inhaled Fluticasone 100 µg, twice daily
16344900|NCT00306150|Drug|Trasylol (Aprotinin, BAYA0128)|Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
16344901|NCT00306150|Drug|Placebo|Placebo is used according to the description of Arm 1
16344902|NCT00306137|Drug|Trasylol (Aprotinin, BAYA0128)|"Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.
~Subjects will be stratified into one of the 4 following strata:
~Stratum 1: complete primary pneumonectomy
~Stratum II: decortication or completion pneumonectomy
~Stratum III: esophagectomy by transhiatal approach
~Stratum IV: esophagectomy by transthoracic approach"
16344903|NCT00306137|Drug|Placebo|Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
16344904|NCT00306124|Drug|Levodopa|
16344905|NCT00306111|Drug|pegfilgrastim|Single dose (6mg) one day after chemotherapy
16344906|NCT00306098|Drug|islets|Islet transplantation
16344907|NCT00306085|Genetic|Autologous bone marrow cells|
16344908|NCT00306072|Drug|nutritional herbal extract from Salacia oblonga|
16344909|NCT00306059|Procedure|Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury|Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.
16344910|NCT00306046|Drug|Bisphosphonate treatment|
16344911|NCT00306033|Drug|Intravenous ImmuneGlobulin|
16344912|NCT00306020|Drug|topical morphine|
16344913|NCT00305968|Behavioral|patient education|Patient education group
16344914|NCT00305955|Device|Spectacles|optimal spectacle correction
16344915|NCT00305942|Drug|Topotecan|Topotecan 4mg/m2 IV on days 1, 8.
16344916|NCT00305942|Drug|carboplatin|Carboplatin AUC=5 IV day 1 only .
16344917|NCT00305929|Drug|Treatment with Tookad VTP|
16344918|NCT00305929|Drug|Treatment with Tookad VTP|Tookad 2 mg/kg
16344919|NCT00305929|Drug|Treatment with Tookad VTP|2 mg/kg
16344920|NCT00305916|Procedure|Multislice spiral computed tomography coronary angiography|
16344921|NCT00305916|Procedure|conventional coronary angiography|
16344922|NCT00305903|Drug|Rivastigmine, memantine|
16344923|NCT00305890|Behavioral|Lifestyle Behavioral Weight Management Program|The lifestyle behavioral weight management program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
16344924|NCT00305890|Behavioral|Pain-Coping Skills Training|The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
16344925|NCT00305890|Other|Standard Care|Standard care will include routine medical care.
16344926|NCT00305877|Biological|cetuximab|Given IV
16344927|NCT00305877|Drug|gemcitabine hydrochloride|Given IV
16344928|NCT00305877|Drug|capecitabine|Given orally
16344929|NCT00305877|Radiation|radiation therapy|Undergo radiation therapy
16344930|NCT00305877|Biological|bevacizumab|Given IV
16344931|NCT00305877|Other|laboratory biomarker analysis|Correlative studies
16344932|NCT00305864|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo radiotherapy
16344933|NCT00305864|Drug|Motexafin Gadolinium|Given IV
16344934|NCT00305864|Drug|Temozolomide|Given orally
16344935|NCT00305851|Procedure|music therapy (books on tape)|
16344936|NCT00305851|Procedure|psychosocial assessment and care|
16344937|NCT00305851|Procedure|quality-of-life assessment|
16344938|NCT00305851|Behavioral|Music Video|Song writing, recording the song with a digital accompaniment track, completing a video layout worksheet (determining the contents of the video), taking photos or making drawings for the video, and viewing clip art and pictures on a computer.
16344939|NCT00305838|Drug|tamoxifen citrate|
16344940|NCT00305838|Other|diagnostic laboratory biomarker analysis|
16344941|NCT00305825|Biological|bevacizumab|
16344942|NCT00305825|Drug|letrozole|
16344943|NCT00305812|Drug|dexamethasone|
16344944|NCT00305812|Drug|lenalidomide|
16344945|NCT00305812|Drug|melphalan|
16344946|NCT00305799|Procedure|management of therapy complications|Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.
16344947|NCT00305786|Drug|gemcitabine hydrochloride|
16344948|NCT00305786|Drug|oxaliplatin|
16344949|NCT00305773|Drug|vorinostat|Given orally once daily
16344950|NCT00305773|Drug|vorinostat|Given orally three times daily
16344951|NCT00305760|Drug|Cetuximab|Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
16344952|NCT00305760|Biological|Pancreatic tumor vaccine|Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
16344953|NCT00305760|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
16345026|NCT00305214|Procedure|T Wave Alternans Test|
16344954|NCT00305747|Drug|BR-DIM|75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects.
16344955|NCT00305734|Drug|bortezomib|Given IV
16344956|NCT00305734|Drug|gemcitabine hydrochloride|Given IV
16344957|NCT00305734|Other|laboratory biomarker analysis|Correlative studies
16344958|NCT00305708|Biological|anti-thymocyte globulin|
16344959|NCT00305708|Drug|busulfan|
16344960|NCT00305708|Drug|fludarabine phosphate|
16344961|NCT00305708|Procedure|allogeneic bone marrow transplantation|
16344962|NCT00305708|Procedure|peripheral blood stem cell transplantation|
16344963|NCT00305708|Procedure|umbilical cord blood transplantation|
16344964|NCT00305708|Radiation|radiation therapy|
16344965|NCT00305695|Other|Laboratory Biomarker Analysis|Correlative studies
16344966|NCT00305695|Drug|Zoledronic Acid|Given IV
16344967|NCT00305682|Biological|anti-thymocyte globulin|Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
16344968|NCT00305682|Drug|cyclophosphamide|Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
16344969|NCT00305682|Drug|Fludarabine|Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
16344970|NCT00305682|Drug|mycophenolate mofetil|Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
16344971|NCT00305682|Procedure|umbilical cord blood transplantation|One or 2 UCB units may be infused to achieve the required cell dose.
16344972|NCT00305682|Radiation|total body irradiation|Administered Day -1, 200 cGy
16344973|NCT00305682|Drug|Sirolimus|Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
16344974|NCT00305669|Biological|sargramostim|
16344975|NCT00305669|Other|immunohistochemistry staining method|
16344976|NCT00305669|Other|immunological diagnostic method|
16344977|NCT00305669|Other|laboratory biomarker analysis|
16344978|NCT00305669|Procedure|conventional surgery|
16344979|NCT00305669|Procedure|neoadjuvant therapy|
16344980|NCT00305656|Drug|cediranib maleate|Given orally
16344981|NCT00305643|Drug|Capecitabine|Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
16344982|NCT00305643|Drug|Celecoxib|200 mg given orally twice a day for each 21 day cycle.
16344983|NCT00305643|Procedure|Radiation Therapy|Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14.
16344984|NCT00305643|Drug|Placebo|Oral placebo twice daily on days 1-21
16344985|NCT00305630|Drug|Periocular injection of triamcinolone acetonide 40mg|
16344986|NCT00305617|Other|antitumor drug screening assay|
16344987|NCT00305604|Drug|sitagliptin phosphate|Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
16344988|NCT00305604|Drug|Comparator: Placebo|sitagliptin matching placebo for up to a 24-wk treatment period.
16344989|NCT00305591|Drug|l-ornithine l-aspartate|
16344990|NCT00305578|Drug|Memantine|Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
16344991|NCT00305578|Drug|Placebo|No active medication, only placebo
16344992|NCT00305565|Device|VNS Therapy|Received output current of 0.25 milliamps (mA)
16344993|NCT00305565|Device|VNS Therapy|Received output current of 0.5-1.0 mA
16344994|NCT00305565|Device|VNS Therapy|Received output current of 1.0-1.5 mA
16344995|NCT00305552|Drug|THALIDOMIDE|THALIDOMIDE
16344996|NCT00305539|Drug|adalimumab|40 mg sc / for 3 months
16344997|NCT00305539|Drug|placebo|placebo
16344998|NCT00305526|Device|Contak Renewal (CRT-D)|
16344999|NCT00305513|Procedure|The phasic alerting treatment|
16345000|NCT00305500|Drug|escitalopram|
16345001|NCT00305487|Drug|Ciclesonide nasal spray|
16345002|NCT00305474|Drug|Risperidone|Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
16345003|NCT00305461|Drug|Ciclesonide|Effect of Ciclesonide on Quality of Life
16345004|NCT00305448|Drug|Fulvestrant|250 intramuscular injection
16345005|NCT00305448|Drug|Fulvestrant|500 mg intramuscular injection
16345006|NCT00305435|Drug|Romiplostim (AMG-531)|Romiplostim (AMG-531)
16345007|NCT00305422|Drug|Quetiapine fumarate|
16345008|NCT00305422|Drug|Risperidone|
16345009|NCT00305409|Drug|Synbiotic (Synergy I / B.longum)|
16345010|NCT00305396|Drug|Sirolimus|
16345011|NCT00305383|Drug|Viramidine|
16345012|NCT00305383|Drug|Peginterferon alfa-2b|
16345013|NCT00305370|Drug|Aripiprazole|
16345014|NCT00305344|Procedure|Autologous Umbilical Cord Blood Transfusion|Cord Blood infusion
16345015|NCT00305344|Biological|Cord blood|Develop Cord blood vaccine
16345016|NCT00305331|Drug|Domperidone (drug)|
16345017|NCT00305292|Drug|Modafinil-Alcohol Interactions|
16345018|NCT00305279|Other|Dietary|Dietary
16345019|NCT00305279|Other|Dietary|Dietary
16345020|NCT00305279|Other|Dietary|Dietary
16345021|NCT00305266|Drug|intravenous gammaglobulin|individual dose
16345022|NCT00305253|Device|Non-pneumatic Anti-shock Garment (NASG)|In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.
16345023|NCT00305240|Procedure|T Wave Alternans Test|
16345024|NCT00305227|Drug|Lactin-V|
16345025|NCT00305227|Drug|Placebo|
16345028|NCT00305188|Drug|Xaliproden (SR57746A)|oral administration
16345029|NCT00305188|Drug|Placebo|oral administration
16345030|NCT00305188|Drug|Oxaliplatin|IV administration
16345031|NCT00305188|Drug|5-Fluorouracil|IV administration
16345032|NCT00305188|Drug|Leucovorin|IV administration
16345033|NCT00305162|Drug|Cangrelor (P2Y12 inhibitor)|IV bolus (30 mcg/kg) & infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion).
16345034|NCT00305162|Drug|clopidogrel (oral P2Y12 inhibitor)|600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access.
16345035|NCT00305162|Drug|Placebo bolus & placebo infusion|placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
16345036|NCT00305162|Drug|Placebo capsules - end of infusion|Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
16345037|NCT00305162|Drug|Placebo capsules - as soon as possible after randomization|Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing
16345038|NCT00305149|Procedure|interim therapy scintigraphy study gallium scan or PET/CT|
16345039|NCT00305149|Procedure|"interim gallium or PET/CT"|
16345040|NCT00305110|Drug|2 mg IV hydromorphone|
16345041|NCT00305097|Dietary Supplement|Decaffeinated coffee|5 cups per day for 8 weeks
16345042|NCT00305097|Dietary Supplement|Caffeinated coffee|5 cups per day for 8 weeks
16345043|NCT00305097|Dietary Supplement|No coffee|
16345044|NCT00305084|Drug|NGR-hTNF|0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks
16345045|NCT00305084|Drug|Doxorubicin|75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
16345046|NCT00305071|Drug|compound cranberry extract tablet|
16345047|NCT00305058|Drug|Morphine|0.05 mg/kg Intravenous
16345048|NCT00305058|Drug|Hydromorphone|0.0075 mg/kg intravenous
16345049|NCT00305045|Device|Repetitive Transcranial Magnetic Stimulation|Magnetic pulses to specified brain structures.
16345050|NCT00305032|Procedure|gastric balloon insertion|patient would be offered endoscopic gastric balloon insertion
16345051|NCT00305019|Drug|clevudine|
16345052|NCT00305006|Procedure|Constraint-Induced Movement Therapy (CIMT)|90 hours
16345053|NCT00305006|Procedure|Hand-Arm Bimanual Intensive Therapy (HABIT)|90 hours
16345054|NCT00304993|Drug|fenofibrate|
16345055|NCT00304993|Drug|niacin|
16345056|NCT00304993|Drug|rosiglitazone|
16345057|NCT00304980|Drug|ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE|
16345058|NCT00304954|Drug|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
16345059|NCT00304954|Drug|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
16345060|NCT00304954|Other|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
16345061|NCT00304954|Drug|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
16345062|NCT00304915|Behavioral|Collaborative Care Interventions|Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
16345063|NCT00304863|Drug|Lactobacillus GG|This arm will receive the additional probiotic of lactobacillus GG
16345064|NCT00304850|Behavioral|polyamine-free diet|Polyamine-free diet in the 7 days befor surgery
16345065|NCT00304850|Drug|Ketamine or placebo|Peroperative and post operative (48h) ketamine injection
16345066|NCT00304837|Genetic|pVGI.1 (VEGF-2)|
16345067|NCT00304811|Drug|Vancomycin|
16345068|NCT00304811|Drug|Vancomycin plus Gentamicin|
16345069|NCT00304811|Drug|Vancomycin plus Rifampin|
16345070|NCT00304811|Drug|Vancomycin plus Gentamicin plus Rifampin|
16345071|NCT00304798|Behavioral|Hospital admission|
16345072|NCT00304785|Drug|latanoprost 0.005%|
16345073|NCT00304785|Drug|Fotil|
16345074|NCT00304785|Drug|placebo|
16345075|NCT00304772|Drug|Fluconazole|400mg/day
16345076|NCT00304772|Drug|Micafungin|150mg/day
16345077|NCT00304759|Procedure|7800 cGy/39 fractions in 8 weeks|see above
16345078|NCT00304759|Procedure|6000 cGy/20 fractions in 4 weeks|see above
16345079|NCT00304746|Drug|Testosterone gel|AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
16345080|NCT00304746|Drug|Placebo|Placebo
16345081|NCT00304733|Device|cast vs. shoe|
16345082|NCT00304720|Drug|Tacrolimus and MMF|
16345083|NCT00304707|Drug|Bupropion|300 mg QD
16345084|NCT00304707|Drug|placebo|placebo
16345085|NCT00304681|Drug|OROS*-Methylphenidate|
16345086|NCT00304668|Drug|dapivirine (TMC120) vaginal gel|
16345087|NCT00304655|Drug|Aripiprazole|
16345088|NCT00304642|Drug|dapivirine (TMC120) vaginal gel|
16345089|NCT00304629|Drug|galantamine|
16345090|NCT00304616|Drug|Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone|
16345091|NCT00304603|Other|No intervention|No treatment was given to the patients as this is an observational study.
16345092|NCT00304590|Drug|XL999|Treatment consisted of 8 weekly infusions of 2.4 mg/kg of XL999 with each infusion given over 4 hours, unless drug-related toxicity required a dosing delay or adjustment. In the absence of progressive disease and unacceptable toxicity, subjects may have received XL999 treatment weekly for up to 1 year on this study.
16345093|NCT00304577|Procedure|Bilateral recession|
16345094|NCT00304577|Procedure|Unilateral recession and resection|
16345095|NCT00304564|Behavioral|Music Listening|subjects listen to music
16345096|NCT00304551|Drug|peginterferon alfa-2a 180μg|180μg（s.c.）/week for 48 weeks
16345097|NCT00304551|Drug|peginterferon alfa-2a 90μg|90μg(s.c.)/week for 48 weeks
16345098|NCT00304551|Drug|ribavirin|600, 800, or 1,000 mg X 2(p.o.)/day
16345099|NCT00304538|Drug|very low dose (VLD) glucagon|
16345100|NCT00304525|Drug|RAF265|A liquid nonaqueous oral formulation. Switched to a tablet formulations with was 60% bioavailable, relative to the liquid at 50mg dose. The liquid dose will be multiplied by a factor of 1.67 to achieve a comparable tablet dose. Tablets are available in 10mg and 50mg strengths.
16345101|NCT00304512|Drug|migalastat HCl|
16345102|NCT00304499|Drug|Oxybutynin|
16345103|NCT00304473|Drug|Quetiapine fumarate|
16345104|NCT00304460|Biological|aldesleukin|
16345105|NCT00304447|Drug|Mylotarg|
16345106|NCT00304434|Drug|Oseltamivir|
16345107|NCT00304434|Drug|Probenecid|
16345108|NCT00304421|Drug|rabeprazole|
16345109|NCT00304421|Drug|pantoprazole|
16345110|NCT00304382|Biological|Prevnar|0.5 ml IM into each deltoid muscle one time (or two in group PCV-PCV)
16345111|NCT00304382|Biological|Pneumovax|0.5 ml IM one time
16345112|NCT00304369|Drug|Metronidazole|
16345113|NCT00304356|Drug|Nitazoxanide|500 mg bid
16345114|NCT00304317|Drug|celecoxib|Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
16345115|NCT00304317|Other|Placebo|Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
16345116|NCT00304304|Behavioral|Asthma education|Research assistant worked with CCC staff on asthma prevention
16345117|NCT00304291|Drug|Mitoxantrone|
16345118|NCT00304278|Drug|Erlotinib (Tarceva)|150 mg daily X 7 weeks
16345119|NCT00304278|Drug|Intra-arterial Cisplatin (PLAT)|1 dose (150 mg/sq) per week X 4 weeks
16345120|NCT00304278|Radiation|Radiation Therapy (RAD)|5 days per week X 7 weeks
16345121|NCT00304265|Biological|COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)|0.5 mL, Intramuscular
16345122|NCT00304252|Drug|Interferon beta-1a|
16345123|NCT00304239|Procedure|Photodynamic therapy with methyl aminolevulinate cream|
16345124|NCT00304226|Drug|valsartan|
16345125|NCT00304226|Drug|amlodipine|
16345126|NCT00304213|Drug|Testosterone|
16345127|NCT00304200|Drug|Temozolomide and SU11248|First Cohort: Temozolomide 100 mg/m2 orally week 1 and week 3 of a 28-day cycle; SU11248, 25 mg/day orally on weeks 2, 3, and 4 or a 28 day cycle.
16345128|NCT00304187|Drug|Erythromycin|Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
16345129|NCT00304187|Drug|Placebo|Placebo, 250 mg or 500 mg, three times a day for 6 weeks
16345130|NCT00304174|Behavioral|Motivation to eat|Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.
16345131|NCT00304161|Drug|Atomoxetine|40 to 80 mg orally once daily for 8 weeks
16345132|NCT00304161|Drug|Placebo|40 to 80 mg orally once daily for 8 weeks
16345133|NCT00304135|Drug|cisplatin|
16345134|NCT00304135|Drug|gemcitabine hydrochloride|
16345135|NCT00304135|Drug|oxaliplatin|
16345136|NCT00304096|Biological|synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine|
16345137|NCT00304083|Biological|filgrastim|Given subcutaneously
16345138|NCT00304083|Drug|doxorubicin hydrochloride|Given IV
16345139|NCT00304083|Drug|etoposide|Given IV
16345140|NCT00304083|Drug|ifosfamide|Given IV
16345141|NCT00304083|Procedure|conventional surgery|Patients undergo surgery
16345142|NCT00304083|Radiation|radiation therapy|Patients undergo radiotherapy
16345143|NCT00304070|Drug|doxorubicin hydrochloride|Given IV
16345144|NCT00304070|Procedure|conventional surgery|Patients undergo surgery
16345145|NCT00304070|Drug|cisplatin|Given IV
16345146|NCT00304070|Drug|mitotane|Given orally
16345147|NCT00304070|Drug|etoposide|Given IV
16345148|NCT00304070|Biological|filgrastim|Given subcutaneously
16345149|NCT00304031|Drug|Concurrent temozolomide|Daily oral temozolomide (75 mg/m2) up to 49 doses.
16345150|NCT00304031|Radiation|Concurrent radiation therapy|60 Gy in 2 Gy fractions
16345151|NCT00304031|Drug|100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle|Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
16345152|NCT00304031|Drug|75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle|Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
16345153|NCT00304018|Biological|anti-thymocyte globulin|
16345154|NCT00304018|Biological|sargramostim|
16345155|NCT00304018|Drug|busulfan|
16345156|NCT00304018|Drug|etoposide|
16345157|NCT00304018|Drug|fludarabine phosphate|
16345158|NCT00304018|Drug|prednisone|
16345159|NCT00304018|Drug|tacrolimus|
16345160|NCT00304018|Procedure|allogeneic hematopoietic stem cell transplantation|
16345161|NCT00304018|Procedure|umbilical cord blood transplantation|
16345162|NCT00304005|Drug|laromustine|
16345163|NCT00303992|Biological|trastuzumab|
16345164|NCT00303992|Drug|irinotecan hydrochloride|
16345165|NCT00303966|Drug|sorafenib tosylate|Given orally
16345166|NCT00303953|Drug|belinostat|Given IV
16345167|NCT00303940|Drug|carboplatin|
16345168|NCT00303940|Drug|talabostat mesylate|
16345169|NCT00303940|Drug|temozolomide|
16345170|NCT00303940|Other|pharmacological study|
16345171|NCT00303927|Drug|capecitabine|
16345172|NCT00303914|Procedure|assessment of therapy complications|
16345173|NCT00303914|Procedure|cognitive assessment|
16345174|NCT00303914|Procedure|psychosocial assessment and care|
16345175|NCT00303901|Procedure|cryosurgery|
16345176|NCT00303901|Procedure|positron emission tomography|
16345177|NCT00303888|Drug|docetaxel|Given IV
16345178|NCT00303888|Drug|idronoxil|Given orally
16345179|NCT00303888|Other|placebo|Given orally
16345180|NCT00303875|Behavioral|behavioral dietary and exercise intervention|
16345181|NCT00303862|Drug|cediranib maleate|Given orally
16345182|NCT00303862|Other|laboratory biomarker analysis|Correlative studies
16345183|NCT00303849|Drug|Carboplatin|Given IA
16345184|NCT00303849|Drug|Etoposide|Given IV
16345185|NCT00303849|Drug|Etoposide Phosphate|Given IV
16345186|NCT00303849|Other|Laboratory Biomarker Analysis|Correlative studies
16345187|NCT00303849|Drug|Mannitol|Given IA
16345188|NCT00303849|Drug|Melphalan|Given IA
16345189|NCT00303849|Other|Quality-of-Life Assessment|Ancillary studies
16345190|NCT00303849|Drug|Sodium Thiosulfate|Given IV
16345191|NCT00303836|Drug|cyclophosphamide|Given IV
16345192|NCT00303836|Drug|fludarabine phosphate|Given IV
16345193|NCT00303836|Biological|therapeutic autologous lymphocytes|Given IV
16345194|NCT00303836|Procedure|in vitro-treated peripheral blood stem cell transplantation|Undergo in vitro-treated peripheral blood stem cell transplantation
16345195|NCT00303836|Biological|gp100 antigen|Given SC
16345196|NCT00303836|Biological|MART-1 antigen|Given SC
16345197|NCT00303836|Biological|incomplete Freund's adjuvant|Given SC
16345198|NCT00303836|Biological|filgrastim|Given SC
16345199|NCT00303836|Biological|aldesleukin|Given IV
16345200|NCT00303823|Drug|placebo|Given orally
16345201|NCT00303823|Dietary Supplement|defined green tea catechin extract|Given orally
16345202|NCT00303823|Other|laboratory biomarker analysis|Correlative studies
16345203|NCT00303810|Drug|carboplatin|
16345204|NCT00303810|Drug|cisplatin|
16345205|NCT00303810|Drug|cyclophosphamide|
16345206|NCT00303810|Drug|etoposide phosphate|
16345207|NCT00303810|Drug|high-dose chemotherapy|
16345208|NCT00303810|Drug|lomustine|
16345209|NCT00303810|Drug|methotrexate|
16345210|NCT00303810|Drug|thiotepa|
16345211|NCT00303810|Drug|vincristine sulfate|
16345212|NCT00303810|Radiation|radiation therapy|
16345213|NCT00303797|Drug|17-N-allylamino-17-demethoxygeldanamycin/bortezomib|
16345214|NCT00303797|Drug|sorafenib tosylate|
16345215|NCT00303784|Drug|Goserelin|3.6mg implant, in pre-filled syringe
16345216|NCT00303784|Drug|Estradiol|Each patch contains 3 mg of estradiol hemihydrate in a patch size of 30 cm2, releasing 100 micrograms of estradiol per 24 hours.
16345217|NCT00303771|Drug|fluorouracil|
16345218|NCT00303771|Drug|irinotecan hydrochloride|
16345219|NCT00303771|Drug|leucovorin calcium|
16345220|NCT00303758|Drug|cisplatin|
16345221|NCT00303758|Drug|fluorouracil|
16345222|NCT00303758|Drug|gemcitabine hydrochloride|
16345223|NCT00303758|Drug|leucovorin calcium|
16345224|NCT00303745|Drug|capecitabine|
16345225|NCT00303745|Drug|irinotecan hydrochloride|
16345226|NCT00303732|Drug|RAD001 (everolimus)|
16345227|NCT00303732|Drug|PTK787 (vatalanib)|
16345228|NCT00303719|Biological|anti-thymocyte globulin|"ATG dose is 15 mg/kg intravenous (IV) every 12 hours for 6 doses on days -6, -5, and -4.
~Those that should/will receive ATG in the preparative regimen:
~Related donor recipients who have not had exposure to combination chemotherapy in the 6 months preceding transplant should
~Unrelated donor recipients who have not had exposure to combination chemotherapy in the 3 months preceding transplant will
~Unrelated donor recipients who have had only a single induction cycle for the treatment of ALL/AML or MDS or CML blast crisis should
~Recipients with a prior autologous transplant in the year prior to second transplant do not require ATG."
16345229|NCT00303719|Drug|cyclophosphamide|Cyclophosphamide will be given in a two hour infusion, total dose 50 mg/kg on day -6.
16345230|NCT00303719|Drug|cyclosporine|Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a level of >200. For adults the initial dose will be 2.5 mg/kg IV over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours. Patients will receive CSA until day +100.
16345231|NCT00303719|Drug|fludarabine|Fludarabine 30 mg/m^2/day intravenous (IV) on day -6 through day -2., total dose 150 mg/m^2 for 5 days.
16345232|NCT00303719|Drug|mycophenolate mofetil|Mycophenolate mofetil (MMF) 1.5 gram twice a day (BID) or if < 50 kg will be given 15 mg/kg orally(po) BID,beginning on day -3, and discontinue at day +30 or 7 days after engraftment (3 consecutive days of absolute neutrophil count (ANC) > 0.5 x 109 /L).
16345233|NCT00303719|Procedure|stem cell transplantation|On day 0, if related donor, stem cells are infused via central line. If unrelated donor, marrow/PBSC is infused after arrival and processing on day 0.
16345234|NCT00303719|Radiation|total body irradiation|The dose of TBI will be 200 cGy given in a single fraction on day -1.
16345235|NCT00303719|Drug|filgrastim|Patients with white blood cell (WBC) counts < 2500 any time after stem cell infusion will be started on G-CSF support at Day +5 at a dose of 5 mcg/kg intravenously or subcutaneously (IV/SQ) daily rounded to vial size until absolute neutrophil count (ANC) > 2500 for 2 consecutive days.
16356941|NCT00205686|Behavioral|exercise|
16345236|NCT00303706|Procedure|Endoscopic Radial Artery Harvest|
16345237|NCT00303667|Biological|aldesleukin|Administered subcutaneously (SQ) 9 million units every other day beginning Day -12 through -2 (evening of natural killer cell infusion) for a total of 6 doses.
16345238|NCT00303667|Biological|natural killer cells|Infusion given on Day -12; The targeted infused cell dose of CD3- CD19- selected NK product is within the range of 2-3 x 10^7 cells/kg.
16345239|NCT00303667|Drug|cyclophosphamide|Administered intravenously (IV) 50 mg/kg on Day -15
16345240|NCT00303667|Drug|fludarabine phosphate|Administered intravenously (IV) 40 mg/m^2 on Days -18 through -14
16345241|NCT00303667|Procedure|allogeneic hematopoietic stem cell transplantation|On day 0, patients will receive an allogeneic transplant using pool cells from the day -1 and day 0 PBSC which will be CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes.
16345242|NCT00303667|Radiation|total body irradiation|Administered on Day -13, 200 cGy two times.
16345243|NCT00303667|Biological|Thymoglobulin|intravenous (IV) 3 mg/kg on Day 0 (day of donor CD34 cell infusion)
16345244|NCT00303667|Drug|Cyclosporin A|1.5 mg/kg by mouth or intravenously for target dose range of 150-250; day -15 through day -8.
16345245|NCT00303667|Drug|cyclophosphamide|Administered intravenously (IV) 50 mg/kg on Days -16 and -15
16345246|NCT00303667|Drug|fludarabine phosphate|Administered intravenously (IV) 35 mg/m^2 on Days -18 through -14
16345247|NCT00303654|Procedure|biopsy|
16345248|NCT00303654|Procedure|therapeutic conventional surgery|
16345249|NCT00303641|Device|Medtronic Resting Heart Bypass System|
16345250|NCT00303628|Drug|oxaliplatin|Given IV
16345251|NCT00303628|Drug|fluorouracil|Given IV
16345252|NCT00303628|Drug|leucovorin calcium|Given IV
16345253|NCT00303628|Drug|bevacizumab|Given IV
16345254|NCT00303615|Drug|Fluoxymesterone 10 mg|
16345255|NCT00303615|Drug|Anastrozole 1 mg|
16345256|NCT00303602|Drug|Sublingual orally disintegrating olanzapine (SODO)|5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
16345257|NCT00303602|Drug|Oral olanzapine|5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
16345258|NCT00303589|Drug|Standard care|As prescribed
16345259|NCT00303589|Drug|beta-lactam|750mg iv q8h
16345260|NCT00303589|Drug|beta-lactam|1500mg iv q8h
16345261|NCT00303576|Drug|dapivirine (TMC120) vaginal gel|
16345262|NCT00303563|Drug|P38 Inhibitor (4)|50mg po qd
16345263|NCT00303563|Drug|P38 Inhibitor (4)|150mg po qd
16345264|NCT00303563|Drug|P38 Inhibitor (4)|300mg po qd
16345265|NCT00303563|Drug|Placebo|po qd
16345266|NCT00303550|Drug|Intravenous iclaprim|
16345267|NCT00303550|Drug|Intravenous linezolid|
16345268|NCT00303537|Drug|metformin|
16345269|NCT00303524|Drug|Goserelin acetate|Injection 3.6 mg monthly
16345270|NCT00303524|Drug|Goserelin acetate|injection 10.8 mg every 3 months
16345271|NCT00303498|Drug|Sitaxsentan sodium|sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
16345272|NCT00303498|Drug|Placebo|placebo identical to the study drug in description, dose and duration
16345273|NCT00303485|Drug|Placebo|po monthly for 6 months
16345274|NCT00303485|Drug|Vitamin D and calcium supplementation|As prescribed
16345275|NCT00303485|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 6 months
16345276|NCT00303472|Drug|Romiplostim|
16345277|NCT00303459|Drug|bosentan|bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.
16345278|NCT00303459|Drug|placebo|Matching bosentan placebo/b.i.d.
16345279|NCT00303446|Drug|Dutasteride|Dutasteride 0.5 mg/day
16345280|NCT00303446|Drug|Placebo|Matched placebo
16345281|NCT00303433|Drug|Namenda|
16345282|NCT00303420|Drug|"Alteplase push protocol"|alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.
16345283|NCT00303420|Drug|alteplase dwell arm|alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary
16345284|NCT00303407|Drug|nadroparin|
16345285|NCT00303394|Drug|IL-1Ra|
16345286|NCT00303381|Drug|Interferon-beta-1a, 44 microgram|Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.
16345287|NCT00303381|Drug|Placebo|Matching Placebo will be administered subcutaneously, three times a week up to Week 8.
16345288|NCT00303381|Drug|Interferon-beta-1a, 66 microgram|Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.
16345289|NCT00303342|Behavioral|mind body treatment|regulation of attention, respiration and posture
16345290|NCT00303342|Behavioral|desensitization|mentation on insomnia behaviors and cognitive activity
16345291|NCT00303329|Drug|Deferasirox|Deferasirox available as 125 mg, 250 mg or 500 mg tablets
16345292|NCT00303316|Biological|DTaP-IPV//PRP~T combined vaccine|0.5 mL, Intramuscular
16345293|NCT00303316|Biological|DTaP-IPV//PRP~T combined vaccine|0.5 mL, Intramuscular
16345294|NCT00303303|Biological|Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)|Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.
16345416|NCT00302211|Drug|Inhaled Placebo|inhaled placebo
16345295|NCT00303303|Biological|Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)|Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.
16345296|NCT00303303|Biological|Placebo|Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.
16345297|NCT00303290|Drug|Peg Interferon Alpha 2b (Peg Intron)|4.5 micrograms/kg once a week
16345298|NCT00303290|Drug|Ara-C (cytosine arabinoside)|10 mg under the skin daily
16345299|NCT00303277|Drug|simvastatin|simvastatin 40 mg tablets once per day for 12 weeks
16345300|NCT00303277|Drug|pravastatin|pravastatin 80 mg tablets once per day for 12 weeks
16345301|NCT00303264|Drug|dexloxiglumide|
16345302|NCT00303264|Drug|Nexium (esomeprazole)|
16345303|NCT00303251|Drug|TKI258|
16345304|NCT00303238|Drug|Rose hips extract + blueberry/blackberry extract + resveravine|
16345305|NCT00303238|Drug|Rose hips extract + blueberry/blackberry extract + Aframomum melegueta extract|
16345306|NCT00303238|Drug|Rose hips extract + resveravine + Aframomum melegueta extract|
16345307|NCT00303225|Drug|Vaccine: SIGA-246|
16345308|NCT00303212|Other|Telemonitoring|Participants in the intervention group are instructed to make a daily toll-free call to an automated telemonitoring system being provided by Pharos Innovations® (Chicago, IL) for 6 months.On each call patients hear a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians at each practice site.
16345309|NCT00303199|Drug|ZIO-101 (Darinaparsin)|IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months
16345310|NCT00303173|Behavioral|Guided Imagery|
16345311|NCT00303160|Drug|vitamin C & E supplements|
16345312|NCT00303147|Behavioral|Expressive Writing|
16345313|NCT00303134|Drug|Islet Cell Transplantation|Islet Cell Transplantation for patients with type 1 diabetes mellitus
16345314|NCT00303108|Drug|Pegylated liposomal doxorubicin|30 mg/m2 IV on Day 1 of each 28 day cycle
16345315|NCT00303108|Drug|Carboplatin|AUC=5 on Day 1 of each 28 day cycle
16345316|NCT00303108|Drug|trastuzumab|4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)
16345317|NCT00303082|Drug|Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14|
16345318|NCT00303069|Biological|V710|Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
16345319|NCT00303069|Biological|Comparator: Placebo|Single dose of saline placebo intramuscularly
16345320|NCT00303056|Drug|HOE140 Icatibant|
16345321|NCT00303043|Procedure|Mixed venous saturation monitoring|Mixed venous saturation monitoring
16345322|NCT00303030|Procedure|1. Anal injection|Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.
16345323|NCT00303030|Procedure|2. Biofeedback|Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.
16345324|NCT00303017|Dietary Supplement|flavocoxid|flavonoid mixture
16345325|NCT00303017|Drug|Naproxen|non-steroidal anti-inflammatory drug
16345326|NCT00303004|Drug|Bosentan and Sildenafil|
16345327|NCT00302978|Behavioral|Behavior therapy|
16345328|NCT00302965|Drug|Frozen Plasma|
16345329|NCT00302952|Drug|Lovastatin|Two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
16345330|NCT00302952|Drug|Placebo|Two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
16345331|NCT00302926|Procedure|energy restriction and maintenance|
16345332|NCT00302913|Drug|Adjustment of clopidogrel dose|
16345333|NCT00302900|Behavioral|Pre-Donation Water Consumption|Consumption of 500 ml of bottled water 30 minutes prior to donating
16345334|NCT00302900|Behavioral|Muscle Tensing Exercise During Donation|Alternating leg lifts at 10-second intervals during donation
16345335|NCT00302900|Behavioral|Muscle Tensing Exercise Prior to Donation|Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
16345336|NCT00302887|Device|combined ultrasound therapy|
16345337|NCT00302887|Procedure|connective tissue manipulation|
16345338|NCT00302874|Behavioral|Implementation of a protocol for treatment of hyperglycemia|
16345339|NCT00302861|Biological|MyVax|
16345340|NCT00302848|Drug|Drospirenone|
16345341|NCT00302848|Drug|Levonorgestrel|
16345342|NCT00302848|Drug|Other progestin containing oral contraceptive|
16345343|NCT00302835|Drug|non-phenacetin containing analgesics|
16345344|NCT00302822|Drug|enfuvirtide|from week 0 to 24
16345345|NCT00302822|Drug|emtricitabine/tenofovir|1 pill/day
16345346|NCT00302822|Drug|lopinavir or efavirenz|investigator choice
16345347|NCT00302809|Dietary Supplement|Concord Grape Juice|Approximately 16 oz of grape juice or placebo
16345348|NCT00302796|Drug|Bioclavid|500 + 125 mg times 3 or 6
16345349|NCT00302796|Drug|Placebo|
16345350|NCT00302783|Behavioral|Multi-Source Feedback: including self-assessment & coaching|
16345351|NCT00302770|Drug|quetiapine|
16345352|NCT00302757|Drug|Radioimmunotherapy|
16345353|NCT00302757|Procedure|allogeneic hematopoietic cell transplantation|
16345354|NCT00302744|Drug|Psilocybin (drug)|One placebo session (niacin) and one active drug session (.2 mg/kg). Treatment sessions are six hours.
16345355|NCT00302731|Drug|Estradiol , estriol , progesterone|
16345356|NCT00302731|Drug|estradiol, progesterone|
16345357|NCT00302731|Drug|estriol, progesterone|
16345358|NCT00302731|Drug|equine estrogens m-progesteroneacetate|
16345359|NCT00302718|Behavioral|Physician-level financial incentives|Enrolled physician participants are eligible to receive financial incentives and audit and feedback reports based on their performance during a 4-month interval on the hypertension care study outcomes.
16345417|NCT00302211|Drug|Sildenafil|oral sildenafil (dosage between 60 and 300 mg/day)
16345360|NCT00302718|Behavioral|Practice-level financial incentives|Enrolled practices (physician physicians and non-physician primary care personnel) are eligible to receive financial incentives and audit and feedback reports based on the performance of the practice during a 4-month interval on the hypertension care study outcomes.
16345361|NCT00302718|Behavioral|Physician- and practice-level financial incentives|Enrolled participants are eligible to receive financial incentives and audit and feedback reports based on performance during a 4-month interval on the hypertension care study outcomes. This arm tests the effect of combined financial incentives (physician-level incentives and practice-level incentives).
16345362|NCT00302705|Drug|Valsartan, Enalapril|160 mg valsartan versus 10-20 mg enalapril
16345363|NCT00302705|Device|Ambulatory blood pressure monitoring|Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
16345364|NCT00302705|Procedure|Missing one dose|Patients skip the dose the second day of monitoring
16345365|NCT00302692|Drug|Esmolol|
16345366|NCT00302692|Drug|Metoprolol|
16345367|NCT00302666|Drug|Valette (Dienogest/EE30, BAY86-5038)|Oral contraceptive extended cycles
16345368|NCT00302666|Drug|Valette (Dienogest/EE30, BAY86-5038)|Oral contraceptive conventional cycles
16345369|NCT00302653|Drug|Rasburicase|Rasburicase 0,20mg/Kg/Day once a day 3-7 days
16345370|NCT00302640|Drug|Alinia (nitazoxanide)|
16345371|NCT00302627|Drug|Pamidronate|60mg or 90mg given at baseline, 6,12,18, and 24 months
16345372|NCT00302627|Drug|vitamin D|baseline, 6,12 months
16345373|NCT00302627|Drug|Calcium Carbonate|baseline, 6,12 months
16345374|NCT00302601|Procedure|Scintigraphic interpretation|Not relevant
16345375|NCT00302575|Behavioral|Collaborative Behavioral Management|
16345376|NCT00302575|Procedure|Integrated parole and outpatient addiction treatment|
16345377|NCT00302549|Drug|FK506|FK506,0.1mg/kg/d
16345378|NCT00302536|Drug|Tacrolimus|Tacrolimus
16345379|NCT00302523|Drug|Tacrolimus|FK506,0.1mg/kg/d
16345380|NCT00302510|Procedure|immunoadsorption|immunoadsorption
16345381|NCT00302497|Drug|basiliximab|
16345382|NCT00302484|Drug|Zoledronate|
16345383|NCT00302471|Drug|Comparator: MK0429|"Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone.
~Disease."
16345384|NCT00302471|Drug|Comparator: MK0429|Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
16345385|NCT00302471|Drug|Comparator: MK0429|Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
16345386|NCT00302471|Drug|Comparator: MK0429|Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
16345387|NCT00302458|Drug|OROS-Methylphenidate|Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules
16345388|NCT00302458|Drug|Immediate Release Methylphenidate|Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules
16345389|NCT00302458|Drug|Placebo|Placebo will be administered during the first part of the day, and again during the second part of the day.
16345390|NCT00302445|Drug|Efalizumab|
16345391|NCT00302445|Device|Narrow Band Phototherapy|
16345392|NCT00302432|Behavioral|Behavior therapy, cigarette holders, Flowers Menthol|
16345393|NCT00302419|Drug|intracoronary infusion,|streptokinase, 250,000 units
16345394|NCT00302419|Procedure|primary percutaneous coronary angioplasty|
16345395|NCT00302406|Drug|methylphenidate hydrochloride|
16345396|NCT00302406|Drug|OROS methylphenidate hydrochloride (CONCERTA)|
16345397|NCT00302393|Drug|OROS methylphenidate hydrochloride|Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours.
16345398|NCT00302393|Drug|methylphenidate hydrochloride|Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours.
16345399|NCT00302380|Radiation|PET imaging using C-11 altropane as the ligand.|A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus.
16345400|NCT00302367|Drug|OROS methylphenidate hydrochloride|
16345401|NCT00302367|Drug|immediate release methylphenidate hydrochloride|
16345402|NCT00302354|Drug|OROS methylphenidate HCl|
16345403|NCT00302354|Drug|SODAS methylphenidate HCl|
16345404|NCT00302341|Drug|Pafuramidine maleate (DB289)|Oral tablet, 100 mg bid, 14 days
16345405|NCT00302341|Drug|Trimethoprim-Sulfamethoxazole (TMP-SMX)|15 mg/kg, oral tablet split tid X 21 days
16345406|NCT00302328|Procedure|macular hole operation|macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
16345407|NCT00302315|Device|transcutaneous electrical nerve stimulation|
16345408|NCT00302302|Drug|L-arabinose|
16345409|NCT00302289|Drug|tyrosine, green tea, caffeine|
16345410|NCT00302276|Drug|Metobes-compound|
16345411|NCT00302263|Drug|Metobes-compound|
16345412|NCT00302250|Drug|ALT-711 (alagebrium chloride)|
16345413|NCT00302237|Device|RX ACCULINK, RX ACCUNET Embolic Protection System|1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.
16345414|NCT00302224|Drug|2S, 4R Ketoconazole (DIO-902)|
16345415|NCT00302211|Drug|Inhaled Iloprost (5 μg)|iloprost inhalation solution (Ventavis) (5 μg)
16357686|NCT00199017|Drug|Vincristine|
16345418|NCT00302211|Drug|Bosentan|oral bosentan (dosage between 62.5 and 125 mg BID)
16345419|NCT00302198|Behavioral|ALS Registry|
16345420|NCT00302185|Procedure|Acupuncture|Insertion of sterile, single-use acupuncture needles at 10-20 points including PC.6, HT.7, St.36, SP.6, and LR.3. Needles were connected to an electrical stimulator to mimick traditional manual stimulation with alternating patterns of stimulation for 20 minutes.
16345421|NCT00302185|Behavioral|Nurse-led supportive care|20-30 minutes of supportive attention from an experienced palliative nurse.
16345422|NCT00302172|Drug|ARQ 197|"Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days).
~Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks.
~All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted."
16345423|NCT00302159|Procedure|adjuvant therapy|
16345424|NCT00302159|Drug|Temozolomide|Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.
16345425|NCT00302159|Drug|Valproic Acid|Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
16345426|NCT00302159|Radiation|Radiation therapy|External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
16345427|NCT00302133|Drug|Naltrexone hydrochloride|Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
16345428|NCT00302133|Other|Placebo|Placebo arm
16345429|NCT00302120|Procedure|Contrast-enhanced MR mammography|
16345430|NCT00302107|Drug|Mirtazapine|Mirtazapine initiated at 15mg qhs and titrated in 15mg increments to a maximum of 45 mg qhs as tolerated.
16345431|NCT00302107|Drug|Placebo|Look-a-like placebo tablets under double-blind conditions
16345432|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.5 mcg/kg QW SC for 24 weeks
16345433|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.0 mcg/kg QW SC for 24 weeks
16345434|NCT00302081|Biological|peginterferon alfa-2b (SCH 54031)|1.5 mcg/kg QW SC for 16 weeks
16345435|NCT00302081|Drug|ribavirin (SCH 18908)|800-1200 mg daily for 24 weeks
16345436|NCT00302081|Drug|ribavirin (SCH 18908)|800-1200 mg daily for 16 weeks
16345437|NCT00302068|Behavioral|Supervised Aerobic Exercise|Supervised aerobic exercise, three times per week, for 16 weeks.
16345438|NCT00302068|Drug|Sertraline|Sertraline (Zoloft), daily, for 16 weeks.
16345439|NCT00302068|Drug|Placebo Pill.|Placebo pill, daily, for 16 weeks.
16345440|NCT00302055|Behavioral|Clinical referral to diabetes prevention lifestyle|16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
16345441|NCT00302055|Behavioral|Clinical referral to group diabetes prevention lifestyle|16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
16345442|NCT00302042|Behavioral|Brief counseling plus group diabetes prevention in community|Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits.
16345443|NCT00302042|Behavioral|Brief Counseling for pre-diabetes alone|Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk.
16345444|NCT00302016|Drug|AMN107|
16345445|NCT00302003|Radiation|radiation therapy|Undergo radiation therapy
16345446|NCT00302003|Drug|doxorubicin hydrochloride|Given IV
16345447|NCT00302003|Drug|vincristine sulfate|Given IV
16345448|NCT00302003|Drug|prednisone|Given orally
16345449|NCT00302003|Drug|cyclophosphamide|Given IV
16345450|NCT00302003|Drug|ifosfamide|Given IV
16345451|NCT00302003|Drug|vinorelbine tartrate|Given IV
16345452|NCT00302003|Drug|dexamethasone|Given IV
16345453|NCT00302003|Drug|etoposide phosphate|Given IV
16345454|NCT00302003|Drug|cisplatin|Given IV
16345455|NCT00302003|Drug|cytarabine|Given IV
16345456|NCT00302003|Biological|filgrastim|Given IV or subcutaneously
16345457|NCT00301990|Biological|aldesleukin|
16345458|NCT00301990|Biological|bevacizumab|
16345459|NCT00301964|Biological|bevacizumab|Given IV
16345460|NCT00301964|Other|laboratory biomarker analysis|Correlative studies
16345461|NCT00301951|Biological|anti-thymocyte globulin|
16345462|NCT00301951|Biological|sargramostim|
16345463|NCT00301951|Drug|busulfan|
16345464|NCT00301951|Drug|fludarabine phosphate|
16345465|NCT00301951|Drug|mycophenolate mofetil|
16345466|NCT00301951|Drug|tacrolimus|
16345467|NCT00301951|Procedure|umbilical cord blood transplantation|
16345468|NCT00301938|Drug|7-hydroxystaurosporine|Given IV
16345469|NCT00301938|Drug|perifosine|Given orally
16345470|NCT00301938|Other|pharmacological study|Correlative studies
16345471|NCT00301925|Biological|pegfilgrastim|
16345472|NCT00301925|Drug|capecitabine|
16345473|NCT00301925|Drug|cyclophosphamide|
16345474|NCT00301925|Drug|epirubicin hydrochloride|
16345475|NCT00301925|Drug|fluorouracil|
16345476|NCT00301925|Drug|methotrexate|
16345477|NCT00301925|Procedure|adjuvant therapy|
16345478|NCT00301912|Biological|filgrastim|
16345479|NCT00301912|Drug|busulfan|
16345480|NCT00301912|Drug|fludarabine phosphate|
16345481|NCT00301912|Drug|methotrexate|
16345482|NCT00301912|Drug|tacrolimus|
16345483|NCT00301912|Procedure|allogeneic bone marrow transplantation|
16345484|NCT00301912|Procedure|allogeneic hematopoietic stem cell transplantation|
16345485|NCT00301912|Procedure|peripheral blood stem cell transplantation|
16345486|NCT00301899|Biological|pertuzumab|
16345487|NCT00301899|Biological|trastuzumab|
16345488|NCT00301886|Drug|ibandronate|
16345489|NCT00301886|Drug|zoledronate|
16345490|NCT00301886|Procedure|quality-of-life assessment|
16345491|NCT00301873|Drug|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
16345492|NCT00301860|Biological|anti-thymocyte globulin|
16345493|NCT00301860|Biological|filgrastim|
16345494|NCT00301860|Biological|therapeutic allogeneic lymphocytes|
16345495|NCT00301860|Drug|cyclosporine|
16345496|NCT00301860|Drug|fludarabine phosphate|
16345497|NCT00301860|Drug|melphalan|
16345498|NCT00301860|Drug|methotrexate|
16345499|NCT00301860|Procedure|allogeneic hematopoietic stem cell transplantation|
16345500|NCT00301860|Procedure|peripheral blood stem cell transplantation|
16345501|NCT00301847|Drug|sorafenib tosylate|
16345502|NCT00301834|Biological|alemtuzumab|
16345503|NCT00301834|Drug|busulfan|
16345504|NCT00301834|Drug|cyclosporine|
16345505|NCT00301834|Drug|fludarabine phosphate|
16345506|NCT00301834|Drug|methotrexate|
16345507|NCT00301834|Drug|methylprednisolone|
16345508|NCT00301834|Procedure|allogeneic bone marrow transplantation|
16345509|NCT00301834|Procedure|allogeneic hematopoietic stem cell transplantation|
16345510|NCT00301834|Procedure|peripheral blood stem cell transplantation|
16345511|NCT00301834|Procedure|umbilical cord blood transplantation|
16345512|NCT00301821|Biological|epratuzumab|
16345513|NCT00301821|Biological|rituximab|
16345514|NCT00301821|Drug|cyclophosphamide|
16345515|NCT00301821|Drug|doxorubicin hydrochloride|
16345516|NCT00301821|Drug|prednisone|
16345517|NCT00301821|Drug|vincristine sulfate|
16345518|NCT00301808|Drug|Cisplatin|Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
16345519|NCT00301808|Drug|Docetaxel|Docetaxel 75 mg/m2 on day 1 of each cycle
16345520|NCT00301808|Drug|Pemetrexed disodium|Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
16345521|NCT00301808|Radiation|Radiation therapy|Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
16345522|NCT00301795|Biological|oblimersen sodium|Given IV
16345523|NCT00301795|Biological|rituximab|Given IV
16345524|NCT00301795|Other|laboratory biomarker analysis|Correlative studies
16345525|NCT00301782|Biological|bleomycin sulfate|
16345526|NCT00301782|Drug|carboplatin|
16345527|NCT00301782|Drug|cisplatin|
16345528|NCT00301782|Drug|etoposide phosphate|
16345529|NCT00301782|Drug|vincristine sulfate|
16345530|NCT00301769|Drug|SJG-136|Given IV
16345531|NCT00301756|Drug|Belinostat|Given IV
16345532|NCT00301756|Other|Laboratory Biomarker Analysis|Correlative studies
16345533|NCT00301730|Biological|aldesleukin|
16345534|NCT00301730|Biological|therapeutic tumor infiltrating lymphocytes|
16345535|NCT00301730|Biological|trastuzumab|
16345536|NCT00301730|Drug|paclitaxel|
16345537|NCT00301730|Procedure|conventional surgery|
16345538|NCT00301691|Behavioral|behavioral dietary intervention|
16345539|NCT00301691|Other|educational intervention|
16345540|NCT00301691|Other|preventative dietary intervention|
16345541|NCT00301678|Behavioral|behavioral dietary intervention|
16345542|NCT00301678|Other|educational intervention|
16345543|NCT00301678|Other|preventative dietary intervention|
16345544|NCT00301665|Biological|Botulinum toxin type A|
16345545|NCT00301652|Drug|mycophenolate mofetil|MMF,1.0g/d
16345546|NCT00301639|Drug|OROS methylphenidate hydrochloride|
16345547|NCT00301639|Drug|methylphenidate hydrochloride|
16345548|NCT00301626|Behavioral|smoking reduction intervention (including NRT)|
16345549|NCT00301613|Drug|Mycophenolate mofetil|MMF,1.0g/d
16345550|NCT00301600|Drug|Mycophenolate mofetil|MMF,1.0g/d
16345551|NCT00301587|Drug|Norgestimate-ethinyl estradiol, with or without folic acid|
16345552|NCT00301574|Drug|galantamine|
16345553|NCT00301561|Procedure|Simplified follow-up approach of ARV treatment|"Simplify treatment follow-up :
~some clinical consultations will be performed by nurses under the physicians' responsibility ;
~the CD4 cell count and HIV-1 viral load will not be available for the management of patients ;
~the biologic assessment for tolerability will be limited"
16345554|NCT00301561|Procedure|Standard follow-up approach of ARV treatment|"Standard treatment follow-up :
~all clinical consultations will be performed by physicians ;
~the CD4 cell count and HIV-1 viral load will be available for the patients management routinely ;
~the biologic assessment for tolerability will be available as needed"
16345555|NCT00301548|Drug|perioperative chemotherapy|
16345556|NCT00301535|Drug|HBOC-201 (hemoglobin glutamer-250 bovine)|HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL
16345557|NCT00301522|Device|TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation|Paclitaxel-Eluting Coronary Stent, Slow-Formulation
16345558|NCT00301522|Device|Express2|Coronary Stent System
16345559|NCT00301509|Drug|peginterferon and ribavirin|
16345560|NCT00301496|Device|Coban 2 Layer Compression System|
16345561|NCT00301483|Drug|Hemoglobin-based oxygen carrier-201 (HBOC 201)|HBOC-201 is an investigational solution of sterile, ultrapurified, glutaraldehyde polymerized, modified bovine hemoglobin (Hb) in a balanced electrolyte solution. HBOC-201 has an Hb concentration of 12-14g/dL. HBOC-201 is an isosmotic solution that is stable for at least 36 months at 2-30ºC. It requires no reconstitution and can be administered directly into a peripheral or central vein. Blood typing is not required because all other cellular components, including the RBC membranes that carry the blood group antigens, have been removed.
16345562|NCT00301483|Other|Standard of Care|Standard Therapy
16345563|NCT00301470|Device|MR urography|undergoing both renal scintigraphy and MR within a month
16345564|NCT00301457|Drug|Anastrozole|1 mg once daily oral dose
16357687|NCT00199017|Drug|Daunorubicin|
16345565|NCT00301444|Device|mirror-box treatment|
16345566|NCT00301444|Behavioral|Mental visualization|
16345567|NCT00301431|Drug|DVS-233|
16345568|NCT00301418|Drug|Erlotinib|Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
16345569|NCT00301405|Drug|Thalidomide|Open label drug
16345570|NCT00301392|Other|life-style intervention|As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.
16345571|NCT00301392|Drug|Life style interventions plus concomitant use of pitavastatin.|Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
16345572|NCT00301379|Other|Observation data collection study.|This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.
16345573|NCT00301366|Drug|alpha-1 proteinase inhibitor (human)|60 mg/kg weekly for 20 weeks
16345574|NCT00301353|Drug|Isoflavones-enriched foods|
16345575|NCT00301340|Drug|5% Lice Asphyxiator lotion - Summers Laboratories, Inc.|
16345576|NCT00301327|Drug|Summers 5% L.A.|
16345577|NCT00301314|Procedure|Autologous stem cell transplant|
16345578|NCT00301301|Drug|Gemcitabine|
16345579|NCT00301301|Drug|Cisplatinum|
16345580|NCT00301301|Drug|Rituximab|
16345581|NCT00301288|Procedure|Autologous stem cell transplant|
16345582|NCT00301262|Drug|Viagra (Sildenafil citrate)|
16345583|NCT00301236|Drug|Dexmethylphenidate HCl extended-release capsules|
16345584|NCT00301223|Drug|Pregabalin|
16345585|NCT00301210|Drug|Tramadol|oral doses four times per day
16345586|NCT00301197|Behavioral|Behavioral Skills Maintenance|
16345587|NCT00301197|Behavioral|Social Facilitation Maintenance|
16345588|NCT00301184|Biological|pGA2/JS7 DNA|DNA Vaccine
16345589|NCT00301184|Biological|Modified vaccinia Ankara/HIV62|Recombinant Modified Ankara Vaccine
16345590|NCT00301171|Drug|Inhaled Fluticasone|
16345591|NCT00301158|Behavioral|exercise intervention|
16345592|NCT00301158|Other|counseling intervention|
16345593|NCT00301158|Other|educational intervention|
16345594|NCT00301158|Procedure|complementary or alternative medicine procedure|
16345595|NCT00301145|Behavioral|smoking cessation intervention|
16345596|NCT00301145|Drug|varenicline|
16345597|NCT00301145|Other|counseling intervention|
16345598|NCT00301145|Other|internet-based intervention|
16345599|NCT00301106|Biological|adenovirus-mediated human interleukin-12|"The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/
~1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC."
16345600|NCT00301093|Biological|GM-K562 cell vaccine|Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations
16345601|NCT00301093|Drug|imatinib mesylate|Participants will continue on current dose
16345602|NCT00301080|Drug|D-cycloserine|
16345603|NCT00301080|Other|Placebo|
16345604|NCT00301067|Dietary Supplement|Calcitriol|The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle
16345605|NCT00301067|Drug|Temozolomide|The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle
16345606|NCT00301054|Drug|Ferrous sulphate|
16345607|NCT00301054|Drug|Sulphadoxine-Pyrimethamine|
16345608|NCT00301041|Other|laboratory biomarker analysis|
16345609|NCT00301041|Procedure|adjuvant therapy|
16345610|NCT00301041|Radiation|radiation therapy|
16345611|NCT00301028|Biological|Cetuximab|Beginning weekly dose 400 mg/m^2 IV over 1-2 hours, and 250 mg/m^2 weeks 2-6.
16345612|NCT00301028|Drug|Carboplatin|AUC 2 weekly for 6 courses.
16345613|NCT00301028|Drug|Paclitaxel|135 mg/m^2 weekly for 6 courses.
16345614|NCT00301028|Procedure|Conventional Surgery|Following induction in second part of study.
16345615|NCT00301028|Radiation|Radiation Therapy|Following induction in second part of study.
16345616|NCT00301015|Device|Rapid diagnostic test for malaria|We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial
16345617|NCT00301002|Drug|Alefacept|
16345618|NCT00300989|Device|Inion OTPS Biodegradable Fixation System|
16345619|NCT00300976|Behavioral|Lifestyle consultation: weight control, diet, exercise|"Behavioral: Lifestyle modification including weight control, with the goal of BMI 22.
~Drug: Drugs are added in a stepwise manner to control blood glucose, blood pressure and lipid metabolism, using mainly hypoglycemic drugs, ACEI/ARB and statins, respectively. Management goals are: HbA1c < 6.2%, BP < 120/75 mmHg, HDL-C 40 mg/dL , LDL-C < 80 mg/dL, TG < 120 mg/dL.
~Follow-up study (Not provided)"
16345620|NCT00300976|Behavioral|Lifestyle consultation: weight control, diet, exercise|"Behavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines.
~Follow-up study (Not provided)"
16345621|NCT00300963|Drug|Talnetant|
16345622|NCT00300950|Biological|GI-4000|Heat-killed yeast cell transfected with target ras mutation.
16345623|NCT00300950|Drug|Gemcitabine|Chemotherapy
16345624|NCT00300937|Dietary Supplement|Coenzyme Q10|100 mg oral BID starting at week 20 until delivery
16345625|NCT00300924|Drug|Rizatriptan co-administered with Acetaminophen|
16345626|NCT00300911|Drug|Rosiglitazone(drug), cardiac adverse effects|
16345627|NCT00300898|Procedure|Nucleoplasty|
16345628|NCT00300898|Procedure|Percutaneous decompression|
16345629|NCT00300898|Procedure|Intervertebral electrothermal disc decompression (IDET)|
16345630|NCT00300898|Behavioral|Conservative treatment|
16345631|NCT00300885|Drug|Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
16345632|NCT00300885|Drug|Carboplatin plus Paclitaxel|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
16345633|NCT00300872|Device|Continuous positive airway pressure (CPAP)|Continuous positive airway pressure (CPAP) - Horizon LT 8001 Continuous positive airway pressure (CPAP) device.
16345634|NCT00300872|Device|Sham Continuous positive airway pressure (CPAP)|Sham Continuous positive airway pressure (CPAP) - Continuous positive airway pressure (CPAP) units set to the lowest pressure (4 cm of water pressure) and 6 extra 4mm holes will be inserted in the collar of the main tubing at the end of the mask to allow air escape and to prevent carbon dioxide rebreathing.
16345635|NCT00300859|Behavioral|brief motivational intervention|
16345636|NCT00300846|Drug|aripiprazole|Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
16345637|NCT00300846|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
16345638|NCT00300833|Drug|Tirofiban|pci
16345639|NCT00300807|Drug|XTL 6865|
16345640|NCT00300794|Drug|Ketamine|
16345641|NCT00300781|Drug|neratinib|
16345642|NCT00300768|Drug|2 mg moxidectin|Single-dose, tablet encapsulated for blinding
16345643|NCT00300768|Drug|ivermectin 150 mcg/kg|Single-dose, tablets encapsulated for blinding
16345644|NCT00300768|Drug|4 mg moxidectin|Single dose, tablets encapsulated for blinding
16345645|NCT00300768|Drug|8 mg moxidectin|single dose, tablets encapsulated for blinding
16345646|NCT00300755|Drug|pantoprazole sodium enteric-coated spheroid|pediatric spheroids taken daily x 8 weeks
16345647|NCT00300742|Drug|Topiramate|Topiramate up to 300 mg per day.
16345648|NCT00300729|Drug|Celecoxib|Celecoxib 400 mg twice daily, orally, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
16345649|NCT00300729|Drug|Placebo|One capsule twice daily, starting on the same day as palliative chemotherapy. Maximum duration of treatment is one year. Treatment should be terminated earlier in case of disease progression, unacceptable toxicity, or if the patient wants to stop treatment.
16345650|NCT00300716|Drug|Memantine|
16345651|NCT00300690|Device|6 mm Uni-graft® (B-Braun)|
16345652|NCT00300690|Device|6 mm Gore-Tex® (WL Gore)|
16345653|NCT00300677|Drug|voriconazole|Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
16345654|NCT00300664|Drug|Human Growth hormone|
16345655|NCT00300651|Behavioral|Cognitive Behavioral Therapy|
16345656|NCT00300638|Procedure|Magnetic Resonance Imaging (MRI)|We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
16345657|NCT00300638|Behavioral|Interviews, cognitive tests, and emotional measurements|We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.
16345658|NCT00300625|Procedure|Application of the San Francisco Syncope Rule|
16345659|NCT00300612|Biological|HyperAcute-Melanoma Vaccine|Cells will be injected intradermally every two weeks for twelve vaccinations. If the patient completes all twelve vaccinations, dosage will vary from a total of 1.3 x 109 to 3.8 x 109 HyperAcute™-Melanoma Vaccine cells administered.
16345660|NCT00300599|Device|Continuous Positive Airway pressure|Continuous positive pressure device with a time clock
16345661|NCT00300599|Other|Placebo|Placebo
16345662|NCT00300586|Drug|observation|observation, second line chemotherapy if progression
16345663|NCT00300586|Drug|gemcitabine|1250 mg/m² D1, D8 q21 days
16345664|NCT00300586|Drug|erlotinib|150 mg daily
16345665|NCT00300573|Drug|Dexelvucitabine|nucleoside inhibitor of HIV Reverse Transcriptase
16345666|NCT00300560|Drug|Colistin|
16345667|NCT00300547|Procedure|MR colonography|Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
16345668|NCT00300534|Device|Abbott Laboratories Determine test for syphilis|
16345669|NCT00300534|Device|Investigational syphilis immunochromatographic strip test|
16345670|NCT00300521|Genetic|ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy|
16345671|NCT00300508|Drug|Anastrozole|
16345672|NCT00300495|Drug|Amiodarone|Perioperative orally administered
16345673|NCT00300495|Other|Control arm, standard care|Control
16345674|NCT00300482|Drug|ABT-335|135 mg, daily, 12 weeks
16345675|NCT00300482|Drug|Rosuvastatin Calcium|Daily, 12 weeks, see Arm Description for dosage information
16345676|NCT00300482|Drug|Placebo|Daily, 12 weeks, see Arm Description for information regarding placebo type
16345677|NCT00300469|Drug|ABT-335|135 mg, daily, 12 weeks
16345678|NCT00300469|Drug|Atorvastatin|Daily, 12 weeks, see Arm Description for dosage information
16345679|NCT00300469|Drug|Placebo|daily, 12 weeks, see Arm Description for placebo information
16345680|NCT00300456|Drug|ABT-335|135 mg, daily, 12 weeks
16345681|NCT00300456|Drug|Simvastatin|daily, 12 weeks, see Arm Description for dosage information
16345682|NCT00300456|Drug|Placebo|Daily, 12 weeks, see Arm Description for placebo information
16345683|NCT00300443|Drug|bimatoprost|
16345684|NCT00300430|Drug|ABT-335 and rosuvastatin calcium|ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
16345685|NCT00300430|Drug|ABT-335 and atorvastatin calcium|ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
16345686|NCT00300430|Drug|ABT-335 and simvastatin|ABT-335 135 mg plus simvastatin daily, 52 weeks
16345687|NCT00300417|Drug|VRC-WNVDNA020-00-VP|
16345688|NCT00300404|Drug|daraprim|
16345689|NCT00300404|Drug|pyrimethamine|
16345690|NCT00300404|Drug|folinic acid|
16345691|NCT00300391|Drug|haloperidol|Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.
16345692|NCT00300391|Other|Saline placebo|control arem
16345693|NCT00300378|Drug|desvenlafaxine 50 mg|
16345694|NCT00300378|Drug|desvenlafaxine 100 mg|
16345695|NCT00300365|Drug|Pioglitazone|Pioglitazone, initially 30 mg, then titrated to 45 mg/day
16345696|NCT00300365|Other|Placebo|Pioglitazone placebo
16345697|NCT00300365|Drug|Niacin ER|Niacin ER 2.0 g/day
16345698|NCT00300365|Drug|Aspirin|asprin 325 mg/day
16345699|NCT00300352|Drug|Folic Acid|
16345700|NCT00300339|Drug|SL650472, Clopidogrel|
16345701|NCT00300326|Procedure|Computer assist|same implant using a computer-assisted surgical technique.
16345702|NCT00300313|Drug|Escitalopram|10 to 20 mg / day
16345703|NCT00300313|Drug|Placebo|1-2 capsules
16345704|NCT00300300|Procedure|Computer-assisted surgery|no description
16345705|NCT00300287|Drug|Vildagliptin|
16345706|NCT00300274|Drug|everolimus|Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
16345707|NCT00300274|Drug|mycophenolate mofetil|Mycophenolate mofetil supplied as 500 mg tablets.
16345708|NCT00300274|Drug|cyclosporine|Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
16345709|NCT00300274|Drug|corticosteroids|Corticosteroids standard dose.
16345710|NCT00300261|Behavioral|Telehealth monitoring|Experimental group receives telehealth monitoring equipment in their homes for the duration of home care. Equipment includes blood pressure cuff, scale, and pulse oximeter, or glucometer as needed. Two home care nurses provide video visits with subjects on the days when the home care nurse does not visit. Patients use the equipment daily and the results are downloaded to the nurse's computer at the home care agency where they are checked daily. The nurse acts on any abnormal readings by calling the patient, the home care nurse, or the physician.
16345711|NCT00300222|Drug|NGX-4010|
16345712|NCT00300196|Biological|Ancrod (Viprinex)|0.167 IU/kg/hr IV for 2-3 hours
16345713|NCT00300196|Drug|Placebo|0.6 mL/kg/hr
16345714|NCT00300157|Device|Percutaneous coronary intervention with Taxus stent|
16345715|NCT00300131|Device|Bioabsorbable Everolimus Eluting Coronary Stent|Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
16345716|NCT00300118|Drug|budesonide|9 mg
16345717|NCT00300118|Drug|mesalazine|4.5 g
16345718|NCT00300105|Drug|Tesaglitazar|
16345719|NCT00300092|Drug|Cepahlexin (drug)|Cephalexin 50 mg/kg divided 3 times daily for 7 days
16345720|NCT00300079|Drug|brinzolamide 1.0%|
16345721|NCT00300053|Biological|CLBS14 (low-dose)|Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
16345722|NCT00300053|Biological|CLBS14 (high-dose)|Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 5 x 10^5 (=500000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
16345723|NCT00300053|Biological|placebo injection|Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Placebo will be delivered in 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma into the target areas of myocardial ischemia.
16345724|NCT00300040|Drug|Hemoglobin glutamer 250 - bovine|intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
16345725|NCT00300040|Drug|6% Hydroxyethylstarch|250ml for intravenous infusion
16345726|NCT00300027|Drug|BMS-582664|
16345727|NCT00300014|Procedure|Intravitreal triamcinolone injection|
16345728|NCT00300014|Procedure|Air-fluid exchange|
16345729|NCT00299988|Drug|Intravenous Immunoglobulin|
16345730|NCT00299988|Other|Placebo|
16345731|NCT00299975|Drug|MaZiRenWan (MZRW) Low dose|Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
16345732|NCT00299975|Drug|MaZiRenWan (MZRW) Median dose|Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
16345733|NCT00299975|Drug|MaZiRenWan (MZRW) High dose|Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
16345855|NCT00298922|Drug|Placebo|tablet orally thrice weekly for 24 weeks
16345734|NCT00299962|Biological|Adenoviral-mediated Interferon-beta|BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
16345735|NCT00299962|Biological|SCH 721015|Comparison of different doses and frequency of investigational agent
16345736|NCT00299936|Drug|Ribavirin, PEG-Intron|
16345737|NCT00299923|Drug|Peginterferon alfa-2a, Ribavirin, Amantadine|
16345738|NCT00299910|Drug|Montelukast|
16345739|NCT00299897|Drug|SP01A|
16345740|NCT00299884|Drug|Lipitor 20 mg|A/A for 6 weeks
16345741|NCT00299884|Drug|Combination Ezetrol 10 mg and Lipidil Supra 160 mg|a/a for 6 weeks
16345742|NCT00299871|Drug|LIXISENATIDE (AVE0010)|
16345743|NCT00299858|Drug|Theophylline|"Patients assigned to study group, will receive slow-release theophylline at a dose of 10 mg/kg, titrated to blood levels between 55-110 umol/L, for a period of 4 weeks.
~Patients assigned to placebo group will receive identical-appearing placebo tablets for the same period of time."
16345744|NCT00299845|Drug|Lansoprazole|
16345745|NCT00299832|Drug|Aliskiren|
16345746|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
16345747|NCT00299819|Biological|MEDI 545|0.3 mg/kg IV (n=6) at Study Day 0
16345748|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
16345749|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
16345750|NCT00299819|Biological|MEDI-545|0.3 mg/kg IV (n=6) at Study Day 0
16345751|NCT00299806|Drug|Aliskiren|
16345752|NCT00299780|Drug|Stem cell mobilization|
16345753|NCT00299767|Procedure|sequential cord blood transplantation|Infused on Day 0
16345754|NCT00299754|Drug|Misoprostol|
16345755|NCT00299741|Drug|Sunitinib|Sunitinib 50 mg daily, 4/2 schedule
16345756|NCT00299728|Biological|NY-ESO-1 protein with CpG 7909 and Montanide|
16345757|NCT00299715|Drug|Paliperidone extended-release|
16345758|NCT00299702|Drug|Abilify|10-30 mg once daily for 104 weeks
16345759|NCT00299702|Drug|Risperidal Consta|25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks
16345760|NCT00299689|Drug|Denileukin diftitox|12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
16345761|NCT00299676|Drug|Galantamine (Reminyl)|Use of Reminyl according to approved NZ data sheet
16345762|NCT00299650|Drug|cisatracurium|
16345763|NCT00299650|Drug|Placebo|physiological serum infusion
16345764|NCT00299650|Drug|Cisatracurium besilate|Cisatracurium besilate infusion (900mg/day)
16345765|NCT00299611|Drug|Sertraline|Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
16345766|NCT00299611|Drug|Levetiracetam|Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
16345767|NCT00299611|Drug|Placebo|Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
16345768|NCT00299598|Device|alkylated polyethylenimine nanoparticles antibacterial evaluation|
16345769|NCT00299585|Procedure|"using PD VitalOs Cement with dental implants"|supporting dental implants with Vitalos bone cement
16345770|NCT00299572|Drug|alendronate (Fosamax)|
16345771|NCT00299559|Drug|smart textiles containing menthol, camphor, cineol|application to skin
16345772|NCT00299546|Drug|Placebo|SC injections
16345773|NCT00299546|Biological|Golimumab 50 mg|SC injections
16345774|NCT00299546|Biological|Golimumab 100 mg|SC injections
16345775|NCT00299533|Drug|Fish oil (Super Omega-3, 4 caps/d) vs. placebo|
16345776|NCT00299520|Drug|intravenous iclaprim or intravenous linezolid|
16345777|NCT00299507|Drug|Anecortave Acetate Sterile Suspension, 30 mg/mL|One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
16345778|NCT00299507|Drug|Anecortave Acetate Sterile Suspension, 60 mg/mL|One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
16345779|NCT00299507|Other|Anecortave Acetate Vehicle|One 0.5 mL sham injection at 6 month intervals
16345780|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
16345781|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
16345782|NCT00299494|Drug|inotuzumab ozogamicin|IV, 1.8 mg/m2, q4w
16345783|NCT00299494|Drug|Rituximab|rituximab 375 mg/m^2 via IV infusion on Day 1
16345784|NCT00299468|Behavioral|Patient Activation Measure Intervention Package|
16345785|NCT00299455|Drug|amoxicillin-clavulanate|Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.
16345786|NCT00299455|Drug|Placebo|Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.
16345787|NCT00299442|Behavioral|Self-help Triple P Behavioural Family Intervention|10-week self-help workbook and videos
16345788|NCT00299429|Procedure|Stenting and minimally invasive bypass surgery|
16345789|NCT00299429|Procedure|PCI with DES|PCI with DES
16345790|NCT00299416|Drug|Caffeinol|Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.
16345791|NCT00299416|Procedure|hypothermia|External or internal cooling for 24 hours and rewarming over 12 hours.
16345792|NCT00299403|Procedure|Right prefrontal lowfrequency ( 1 hz) rTMS.|"Right prefrontal low frequency (1 hz) rTMS. 15 sessions with one daily session during 3 weeks (weekends excluded). Each session covering 2 x 60 minutes of stimulation separated with an intertrain interval of 3 minutes
~Arms: 2"
16345793|NCT00299403|Procedure|Electroconvulsive therapy (ECT)|9 ECT ( 3 each week) during 3 weeks
16345794|NCT00299390|Drug|Sagopilone (BAY86-5302, ZK 219477)|Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
16345795|NCT00299377|Drug|Abciximab i.v.|
16345796|NCT00299377|Drug|Abciximab i.c.|
16345797|NCT00299364|Drug|Black Cohosh (iCR) or tibolone|
16345798|NCT00299351|Drug|Depsipeptide|
16345799|NCT00299338|Drug|SP01A|
16345800|NCT00299325|Drug|Rimonabant|Tablet, oral administration
16345801|NCT00299325|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16345856|NCT00298909|Behavioral|physical exercise|physical exercise
16345802|NCT00299325|Other|Mild hypocaloric diet|Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
16345803|NCT00299286|Drug|Lapatinib|"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
~Lapatinib tablets are dispensed as 250mg tablets. Patients should be advised to take all 6 tablets at once as one dose (total daily dose 1500mg). Tablets should be taken on an empty stomach either one hour before or one hour after a meal at the same time each day and according to the instructions on the bottle."
16345804|NCT00299286|Drug|Lapatinib-Placebo|"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
~Lapatinib-placebo tablets will be composed of lactose, cellulose, starch, magnesium stearate, and coated with Opadryl orange and look the same as the active treatment. The patients should take all 6 tablets at once as one dose."
16345805|NCT00299273|Behavioral|Low calorie high fat/protein diet|6 weeks of caloric restriction (50%) on a high fat/protein diet
16345806|NCT00299260|Biological|CMV gB vaccine|20 micrograms
16345807|NCT00299260|Drug|Placebo|normal saline
16345808|NCT00299247|Drug|sulfadoxine/pyrimethamine|
16345809|NCT00299234|Drug|Atomoxetine|titration schedule: 0.5 to 1.5 mg/kg/day
16345810|NCT00299221|Drug|Tacrolimus|tacrolimus
16345811|NCT00299221|Drug|combination therapy|MMF
16345812|NCT00299208|Drug|Artesunate|
16345813|NCT00299208|Drug|Azithromycin|
16345814|NCT00299208|Drug|Quinine|
16345815|NCT00299195|Drug|sulindac|Sulindac 150 mg po bid x 24 weeks
16345816|NCT00299195|Drug|Placebo|Placebo bid x 24 weeks
16345817|NCT00299182|Drug|AMG 531|Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.
16345818|NCT00299182|Drug|Rituximab|375 mg/m^2 by vein over 4-6 hour infusion day 1, each cycle.
16345819|NCT00299182|Drug|Cyclophosphamide|300 mg/m^2 by vein over 3 hours every 12 hours for 6 doses (days 2-4), Cycles 1,3, & 5.
16345820|NCT00299182|Drug|Vincristine|1.4 mg/m^2/dose (maximum 2 mg) by vein over 15 minutes Days 5 and 12, Cycles 1,3,& 5.
16345821|NCT00299182|Drug|Doxorubicin|50 mg/m^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,& 5.
16345822|NCT00299182|Drug|Dexamethasone|40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,& 5.
16345823|NCT00299182|Drug|Methotrexate|200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours Day 2, Cycles 2, 4 & 6.
16345824|NCT00299182|Drug|Cytarabine|3 g/m^2 by vein over 2 hours every 12 hours for 4 doses, days 3 & 4; OR,1 g/m^2 by vein over 2 hours every 12 hours for 4 doses, days 3 & 4 for patients > 60 years and for patients with serum creatinine > 1.5 mg/dL; Cycles 2,4,& 6.
16345825|NCT00299182|Drug|Placebo|Arm A: Placebo - subcutaneous injection administered on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm B: Placebo - subcutaneous injection administered on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.
16345826|NCT00299169|Behavioral|N of 1 Trials|N of 1 Trials of statin therapy
16345827|NCT00299156|Drug|Clofarabine|Starting dose 10 mg (Group 1) or 20 mg (Group 2) as tablets once a day for 5 days in a row and repeated every 4-8 weeks. Each 4-8 week period is a cycle.
16345828|NCT00299130|Drug|Folate|A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
16345829|NCT00299130|Drug|Methotrexate|A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
16345830|NCT00299130|Drug|Methylprednisolone|Intravenous infusion
16345831|NCT00299130|Drug|Placebo|Placebo to rituximab intravenous infusion
16345832|NCT00299130|Drug|Rituximab|Intravenous infusion
16345833|NCT00299117|Behavioral|Brief preoperative smoking intervention|One counseling session of approximately 45 minutes duration 3-4 days preoperatively. The intervention is inspired by the principles of motivational interviewing and The Stages of Change Model.
16345834|NCT00299104|Drug|folate|Intravenous repeating dose
16345835|NCT00299104|Drug|methotrexate|Oral or parenteral repeating dose
16345836|NCT00299104|Drug|methylprednisolone|Intravenous repeating dose
16345837|NCT00299104|Drug|placebo|Intravenous repeating dose
16345838|NCT00299104|Drug|rituximab|Intravenous repeating dose
16345839|NCT00299091|Drug|Efavirenz capsules 200 mg and 600 mg|Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)
16345840|NCT00299065|Drug|Zileuton injection|
16345841|NCT00299052|Device|Grafton DBM|Grafton DBM will be mixed with bone reamings obtained during tibia IMN and place at the fracture site
16345842|NCT00299052|Biological|Reamings|Bone reamings obtained during tibia IMN will be placed at the fracture site
16345843|NCT00299039|Drug|acetaminophen plus codeine|capsules four times daily until pain free or for a maximum of seven days
16345844|NCT00299039|Drug|acetaminophen plus ibuprofen|capsules four times daily until pain free or for a maximum of seven days
16345845|NCT00299026|Device|NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System|
16345846|NCT00299013|Drug|COLAL-PRED®|COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
16345847|NCT00299013|Drug|Prednisolone|Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
16345848|NCT00299000|Drug|Naglazyme|Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution
16345849|NCT00298987|Drug|Dasatinib|Tablets, Oral, 70 mg, Twice daily, 2 months.
16345850|NCT00298974|Drug|hydrocodone / acetaminophen extended release|2 tablets twice daily
16345851|NCT00298974|Drug|Placebo|2 tablets twice daily
16345852|NCT00298961|Device|Videoconference equipment FALCON/IP|
16345853|NCT00298935|Procedure|Osteopathic manipulative treatment (OMT)|
16345854|NCT00298922|Drug|Azithromycin|500 mg tablets orally thrice weekly for 24 weeks
16357688|NCT00199017|Drug|Asparaginase|
16345857|NCT00298909|Drug|niaspan (extended-release niacin)|niaspan (extended-release niacin)
16345858|NCT00298909|Drug|niacin|niacin extended-release
16345859|NCT00298909|Other|control|control
16345860|NCT00298896|Drug|SNS-595|
16345861|NCT00298883|Drug|Myfortic|Myfortic 360mg PO BID for six weeks
16345862|NCT00298870|Drug|Isoniazid|Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively
16345863|NCT00298870|Drug|isoniazed|Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
16345864|NCT00298857|Drug|Valproic acid|
16345865|NCT00298831|Drug|Sugammadex|At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.
16345866|NCT00298831|Drug|Rocuronium|Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.
16345867|NCT00298792|Behavioral|Cognitive Behavioral Treatment|Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.
16345868|NCT00298792|Behavioral|Cognitive-behavioral treatment|Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety
16345869|NCT00298779|Drug|omeprazole and bortezomib|
16345870|NCT00298766|Drug|VELCADE|"Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2
~Or
~Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2"
16345871|NCT00298753|Procedure|fluid restriction for 14 days (15ml fluid per kg weight)|
16345872|NCT00298740|Device|Aventis U-400 Insulin|
16345873|NCT00298727|Behavioral|SHIPS|Stakeholder-Hosted Interactive Problem-based Seminars
16345874|NCT00298727|Behavioral|ePBL|Online Problem-Based Course
16345875|NCT00298714|Drug|Losartan|
16345876|NCT00298701|Biological|ALK Grass tablet|
16345877|NCT00298688|Drug|Gefitinib|
16345878|NCT00298675|Drug|BSI-201 (iniparib)|BSI-201 administered intravenously (IV), 2x weekly
16345879|NCT00298675|Drug|irinotecan|Irinotecan administered weekly, IV.
16345880|NCT00298662|Drug|Interferon beta-1b and Tacrolimus|
16345881|NCT00298649|Behavioral|Lay Health Advisor|
16345882|NCT00298636|Drug|adenosine|
16345883|NCT00298623|Drug|XP13512 (GSK1838262)|
16345884|NCT00298623|Other|placebo|
16345885|NCT00298610|Drug|Artesunate|Intravenous Artesunate (2.4 mg/kg) once a day for three days
16345886|NCT00298610|Drug|Malarone|(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
16345887|NCT00298597|Drug|granulocyte - colony stimulating factor (G-CSF)|
16345888|NCT00298597|Drug|erythropoetin (EPO)|
16345889|NCT00298584|Procedure|Percutaneous Suprapubic Aspiration|
16345890|NCT00298584|Procedure|Urethral Catheterization|
16345891|NCT00298571|Drug|.5% bupivacaine with epinephrine|
16345892|NCT00298558|Behavioral|Cognitive Training|Memory, Reasoning, or Speed of Processing cognitive training interventions
16345893|NCT00298545|Drug|placebo and Calcitriol|Placebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
16345894|NCT00298545|Drug|Calcium and Calcitriol|Calcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
16345895|NCT00298532|Procedure|Advanced Life Support|
16345896|NCT00298506|Drug|Multitherapy|Tacrolimus,4mg/d, MMF 1.0g/d
16345897|NCT00298493|Procedure|Sedation management strategy|
16345898|NCT00298467|Drug|MDX-060|
16345899|NCT00298454|Drug|Furosemide|
16345900|NCT00298441|Drug|chondroitin sulfate-iron colloid|
16345901|NCT00298428|Procedure|blood samples|blood samples before percutaneous coronary intervention (PCI) and at 4 months
16345902|NCT00298415|Drug|Paclitaxel + Carboplatin|Paclitaxel 90 mg/m² D1, D8, D15 (D1=D29, 4 cycles) Carboplatin AUC 6 D1 (D1=D29, 4 cycles)
16345903|NCT00298415|Drug|Monotherapy (gemcitabine or vinorelbine)|Gemcitabine 1150 mg/m² D1 and D8 (D1=D22, 5 cycles) Vinorelbine 30 mg/m² D1 and D8 (D1=22, 5 cycles)
16345904|NCT00298363|Drug|Tenofovir disoproxil fumarate (tenofovir DF; TDF)|300-mg tablet QD
16345905|NCT00298363|Drug|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)|FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD
16345906|NCT00298363|Drug|Entecavir (ETV)|0.5-mg or 1-mg tablet QD
16345907|NCT00298363|Drug|TDF placebo|Placebo to match TDF QD
16345908|NCT00298363|Drug|FTC/TDF placebo|Placebo to match FTC/TDF QD
16345909|NCT00298363|Drug|ETV placebo|Placebo to match ETV QD
16345910|NCT00298350|Drug|GS-9137 - A Novel HIV-1 Integrase Inhibitor|
16345911|NCT00298337|Drug|Mixture of probiotic bacteria and prebiotic oligosaccharide|
16345912|NCT00298324|Drug|Myfortic|1440mg twice daily
16345913|NCT00298324|Drug|Prednisone and Cyclosporine|Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response
16345914|NCT00298311|Behavioral|mci guidance peer support|12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
16345915|NCT00298298|Biological|L-Vax: Autologous, DNP-Modified NSCLC Vaccine|autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
16345916|NCT00298285|Drug|enoxaparin|
16345917|NCT00298272|Biological|IDEC-C2B8 (rituximab)|Participants will receive 500 mg rituximab on Day 1 and Day 15
16345918|NCT00298272|Drug|Placebo|Participants will receive placebo on Day 1 and Day 15
16345919|NCT00298272|Drug|Methotrexate|Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for at least 12 weeks immediately prior to Day 1, at a stable dose for at least 4 weeks and was continued for the study duration.
16345920|NCT00298272|Drug|Etanercept|Participants must have been treated with etanercept at 50 mg per week (25 mg twice per week or 50 mg once per week).
16345921|NCT00298272|Drug|Adalimumab|Participants must have been treated with adalimumab at 40 mg every other week for at least 12 weeks immediately prior to Day 1.
16345922|NCT00298272|Drug|Methylprednisolone|Methylprednisolone 100 mg IV was administered by slow infusion to be completed at least 30 minutes prior to each infusion of rituximab or placebo.
16345923|NCT00298272|Dietary Supplement|Folate|All subjects also received a stable dose of folate (≥5 mg per week).
16345924|NCT00298259|Procedure|operative fixation of fractured ribs|ORIFof fractured ribs in flail chest patients
16345925|NCT00298233|Drug|Oseltamivir|Oseltamivir is a sialic acid analogue that potently and specifically inhibits the viral neuraminidases by competitively and reversibly interacting with the active enzyme site of influenza A and B viruses. Oseltamivir will be administered orally in standard formulations (capsules for adults and children at least 15 years of age; suspension for children younger than 15 years).
16345926|NCT00298220|Behavioral|Feedback about patients at risk|GPTs receive this feedback about their patient population; obtained through premeasurement results
16345927|NCT00298220|Behavioral|Dissemination guideline and patient information letters|
16345928|NCT00298220|Behavioral|Tailored educational training|for GP(T)s
16345929|NCT00298220|Behavioral|Tailored outreach based facilitator support|in the practices of the GPTs
16345930|NCT00298220|Behavioral|Facilitation of co-operation with local addiction services|
16345931|NCT00298220|Behavioral|Patient directed interventions|Like poster for the waiting room, self-help booklets, folders
16345932|NCT00298220|Behavioral|Reminder-card for GP's desk|
16345933|NCT00298220|Behavioral|Personal feedback to patients|Patients receive advise based on their premeasurement answers
16345934|NCT00298207|Behavioral|Walking (behavior)|
16345935|NCT00298194|Drug|Z-338|
16345936|NCT00298181|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion open-label at 0.07, 0.22, 0.7 or 2.2 mg/kg
16345937|NCT00298168|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
16345938|NCT00298168|Drug|placebo|0.9% normal saline administered IV as a single bolus infusion with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
16345939|NCT00298168|Drug|YSPSL|YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 10 mg YSPSL in 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
16345940|NCT00298155|Drug|goserelin with dutasteride|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.
16345941|NCT00298155|Drug|goserelin with bicalutamide and dutasteride|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.
16345942|NCT00298155|Drug|goserelin with bicalutamide and dutasteride and ketoconazole|Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).
16345943|NCT00298142|Procedure|Usual Care provided by a medical doctor (GP or Neurologist)|
16345944|NCT00298142|Procedure|Usual care plus Physio-/ Manual Therapy|
16345945|NCT00298129|Device|Ambulatory blood pressure monitoring|
16345946|NCT00298090|Device|StO2 monitoring|placement of the StO2 device/ external noninvasive
16345947|NCT00298064|Genetic|Tissue Repository|
16345948|NCT00298051|Procedure|Delayed umbilical cord clamping|
16345949|NCT00298038|Drug|Rifaximin|Oral
16345950|NCT00298038|Drug|Placebo|Oral
16345951|NCT00298025|Drug|Cetrotide®|Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is >=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.
16345952|NCT00298025|Drug|Antagon ™|Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is >=14 mm until r-hCG day.
16345953|NCT00298025|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.
16345954|NCT00298025|Drug|Human Menopausal Gonadotropin (hMG)|Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).
16345955|NCT00298025|Drug|Recombinant Human Choriogonadotropin (r-hCG)|The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of >=18 mm and two additional follicles of >=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.
16345956|NCT00298012|Drug|Methotrexate|
16345957|NCT00297986|Device|Helmet|Evaluation of different interfaces for NPPV
16345958|NCT00297973|Procedure|Blood pressure measurements|
16345959|NCT00297973|Procedure|Blood samples|
16345960|NCT00297960|Drug|ziprasidone or olanzapine|
16345961|NCT00297960|Procedure|hyperinsulinaemic euglycaemic clamp|
16345962|NCT00297960|Procedure|microdialysis (skeletal muscle)|
16345963|NCT00297947|Drug|quetiapine|Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
16345964|NCT00297947|Drug|quetiapine|Participant will receive 600 mg/day of quetiapine for 8 weeks.
16345965|NCT00297934|Device|Pro-adjuster mechanical spinal manipulative device|
16345966|NCT00297921|Drug|tandutinib|
16345967|NCT00297895|Procedure|Completion Lymphadenectomy|complete lymph node dissection of lymph node basin with positive node
16345968|NCT00297895|Procedure|Monitoring with nodal ultrasound|serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
16345969|NCT00297882|Drug|1. Artemether-Lumefantrine (AL)|Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
16345970|NCT00297882|Drug|2. Amodiaquine-Artesunate (AQ-AS)|Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg
16346021|NCT00297466|Behavioral|Motivational interview|
16357689|NCT00199017|Drug|G-CSF|
16345971|NCT00297869|Procedure|Computer-Assisted Decision Support|Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance)
16345972|NCT00297856|Biological|Boostrix®|Single dose
16345973|NCT00297856|Biological|Td (Tetanus diphtheria) vaccine|Single dose
16345974|NCT00297843|Procedure|allergen challenge (grass pollen), nasal lavage|
16345975|NCT00297830|Drug|Zoledronic acid|Drug is administered through 5 mg intravenous infusion over 20 minutes
16345976|NCT00297830|Drug|Alendronate|Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
16345977|NCT00297830|Other|Placebo Zoledronic Acid|Infusion of placebo zoledronic acid during the first 5 weeks after transplantation
16345978|NCT00297830|Other|Placebo Alendronate|Placebo alendronate 70 mg once weekly
16345979|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
16345980|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
16345981|NCT00297817|Biological|serogroup B meningococcal vaccine|0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
16345982|NCT00297804|Device|TAXUS Express Paclitaxel-Eluting Coronary Stent System|Paclitaxel-Eluting Coronary Stent System
16345983|NCT00297804|Device|Control stent|control stent
16345984|NCT00297791|Procedure|surgery|randomized to open or laparoscopic technique
16345985|NCT00297778|Drug|Pramipexole|Dopamine agonist
16345986|NCT00297778|Other|Placebo|
16345987|NCT00297765|Drug|Tacrolimus, Prograf®|
16345988|NCT00297752|Drug|ceriumnitrate silversulfadiazine (flammacerium)|treatment of patients with facial burns with CE-SSD
16345989|NCT00297752|Drug|silversulfadiazine (flammazine)|treatment of patients with facial burns with SSD
16345990|NCT00297739|Drug|Risperidone|
16345991|NCT00297726|Behavioral|Self-Management Program|
16345992|NCT00297713|Drug|ALTU-238|
16345993|NCT00297700|Behavioral|Active referral|
16345994|NCT00297687|Biological|MnB rLP2086|
16345995|NCT00297674|Drug|Intravenous Clarithromycin|
16345996|NCT00297661|Device|Sirolimus-eluting stent|
16345997|NCT00297661|Device|Paclitaxel-eluting stent|
16345998|NCT00297648|Biological|Certolizumab pegol|Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
16345999|NCT00297635|Device|GlucoDYNAMIX™ intervention system|
16346000|NCT00297635|Device|GlucoMON™ telemetry device|
16346003|NCT00297583|Drug|Insulin Glulisine|
16346004|NCT00297570|Drug|Pegylated Interferon and Imatinib|
16346005|NCT00297544|Drug|Viagra|
16346006|NCT00297531|Device|PerioWave|
16346007|NCT00297531|Procedure|Scaling and Root Planing|
16346008|NCT00297518|Device|PerioWave|
16346009|NCT00297518|Procedure|Scaling and Root Planing|
16346010|NCT00297505|Drug|citalopram|
16346011|NCT00297492|Behavioral|Reduction Phone Counseling|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.
16346012|NCT00297492|Behavioral|Abrupt Phone Counseling|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
16346013|NCT00297492|Behavioral|Minimal Abrupt Phone Counseling|Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
16346014|NCT00297492|Drug|Pre-Quit Nicotine Lozenges|"2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
~4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
~Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke."
16346015|NCT00297492|Drug|Post-Quit Nicotine Lozenges|"2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
~4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
~Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke."
16346016|NCT00297479|Behavioral|MBAT Group Therapy|In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
16346017|NCT00297479|Drug|Nicotine|6 weeks of nicotine patch therapy
16346018|NCT00297479|Behavioral|Group Therapy|In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
16346019|NCT00297479|Behavioral|Individual Therapy|In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
16346020|NCT00297466|Drug|transdermal nicotine patches|
16346022|NCT00297453|Behavioral|Internet-based smoking treatment|All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.
16346023|NCT00297453|Behavioral|Individual Counseling|Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
16346024|NCT00297453|Behavioral|self-help|Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.
16346025|NCT00297440|Behavioral|Cognitive-behavioral treatment|
16346026|NCT00297440|Behavioral|Exercise|
16346027|NCT00297427|Procedure|Acupuncture|Acupuncture twice weekly for 6 weeks.
16346028|NCT00297427|Other|Sham acupuncture|Twice a week for 6 weeks
16346029|NCT00297414|Other|No intervention|No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
16346030|NCT00297401|Drug|ruboxistaurin|32 mg, QD, PO, up to 8 weeks
16346031|NCT00297401|Drug|placebo|QD, PO, up to 8 weeks
16346032|NCT00297388|Drug|Risperidone, long-acting injectable|
16346033|NCT00297375|Drug|tramadol HCl/acetaminophen|
16346034|NCT00297362|Drug|Galantamine hydrobromide|247 patients with diagnosed mild to moderate Alzheimer disease.
16346035|NCT00297349|Drug|Topiramate|Individualization of the treatment should begin from 25 mg for 1 week.
16346036|NCT00297336|Drug|Topiramate|80 patients with diagnosed with migraine
16346037|NCT00297323|Drug|Topiramate|75 patients over the age of 2 years old with epilepsy.
16346038|NCT00297310|Drug|tacrolimus|
16346039|NCT00297297|Other|No intervention. Applying gene profiling on needle aspirates|
16346040|NCT00297284|Drug|Modafinil|
16346041|NCT00297271|Other|Current treatment practice of each participating physician|Patients will be observed for the evaluation of current management strategies.
16346042|NCT00297258|Drug|pazopanib|oral tablet
16346043|NCT00297245|Drug|cognitive function|
16346044|NCT00297232|Drug|Natalizumab|
16346045|NCT00297219|Drug|Low dialysate calcium|1.25 mmol/L dialysate calcium
16346046|NCT00297219|Drug|high dialysate calcium|1.75 mmol/L dialysate calcium
16346047|NCT00297206|Drug|Valaciclovir|Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
16346048|NCT00297193|Procedure|Autologous haematopoietic stem cell transplant|All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
16346049|NCT00297180|Drug|GW869682|
16346050|NCT00297167|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
16346051|NCT00297167|Drug|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
16346052|NCT00297167|Drug|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
16346053|NCT00297167|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
16346054|NCT00297154|Behavioral|Lifestyle Modification (diet, exercise, and behavior)|Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
16346055|NCT00297141|Drug|Capecitabine|chemotherapy oral use
16346056|NCT00297141|Drug|Oxaliplatin|chemotherapy intravenous use
16346057|NCT00297128|Drug|Capecitabine|825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
16346058|NCT00297128|Drug|Cetuximab|400mg/m2 week 1, 250mg/m2 week 2-4
16346059|NCT00297115|Drug|Roflumilast|500 mcg, once daily, oral administration in the morning
16346060|NCT00297115|Drug|Placebo|once daily
16346061|NCT00297102|Drug|Roflumilast|500 mcg, once daily, oral administration in the morning
16346062|NCT00297102|Drug|Placebo|once daily
16346063|NCT00297089|Drug|ABT-751|200 mg ABT-751 daily for 14 days every 21 days
16346064|NCT00297089|Drug|pemetrexed|Standard pemetrexed every 21 days
16346065|NCT00297089|Drug|placebo|Placebo daily for 14 days every 21 days
16346066|NCT00297076|Drug|GW873140|
16346067|NCT00297063|Drug|Rosiglitazone|
16346068|NCT00297050|Drug|Peramivir|
16346069|NCT00297037|Drug|Pimecrolimus 1% cream|pimecrolimus cream or matching placebo BID for 6 weeks
16346070|NCT00297024|Procedure|MRI|Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.
16346071|NCT00297011|Drug|valacyclovir+clobetasol gel|
16346072|NCT00296985|Device|Fresenius Cellsaver|
16346073|NCT00296972|Drug|peg interferon plus ribavirin|
16346074|NCT00296959|Drug|topiramate (drug)|
16346075|NCT00296946|Drug|ipratropium bromide (drug)|
16346078|NCT00296920|Device|Deep Brain Stimulation|
16346079|NCT00296907|Behavioral|Brief psychological intervention|Psychoeducation, provision of medical knowledge, coping skills training
16346080|NCT00296894|Drug|Adalimumab (40 mg sc every other week)|Adalimumab (40 mg sc every other week)
16346081|NCT00296894|Drug|Placebo|Placebo
16346082|NCT00296881|Device|PERIOWAVE|
16346083|NCT00296868|Drug|ascorbic acid (vitamin C) versus placebo|
16346084|NCT00296855|Drug|Vasovist (BAY86-5283, MS-325)|All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL
16346085|NCT00296842|Behavioral|Early psychological intervention|Psychoeducation, trauma narrative, provision of coping skills
16346086|NCT00296829|Biological|Inactivated, split-virion influenza vaccine|
16346087|NCT00296816|Drug|Bevacizumab (Avastin®)|15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity
16346088|NCT00296816|Drug|Docetaxel (Taxotere®)|75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
16346089|NCT00296816|Drug|Oxaliplatin (Eloxatin®)|85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
16346090|NCT00296803|Drug|clopidogrel|
16346091|NCT00296790|Drug|zolpidem tartrate|
16346092|NCT00296777|Drug|Escitalopram|8 weeks: up to 40 mg/day
16346093|NCT00296777|Drug|Bupropion|8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
16346094|NCT00296777|Drug|Imipramine|"8 weeks: up to 300mg/day
~*if patient does not have contraindication."
16346095|NCT00296751|Procedure|ECG recording|
16346096|NCT00296751|Procedure|Epidural catheter insertion|
16346097|NCT00296751|Drug|Intravenous meperidine injection|
16346098|NCT00296751|Drug|Epidural Bupivacaine and fentanyl injection|
16346099|NCT00296738|Device|SPECT/CT|GE INFINIA HAWKEYE
16346100|NCT00296725|Drug|Fluoxetine|Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.
16346101|NCT00296725|Drug|Imipramine|Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated.
16346102|NCT00296712|Drug|escitalopram + bupropion|same dosing as for monotherapy arms
16346103|NCT00296699|Drug|Duloxetine|"Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d.
~* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating."
16346104|NCT00296686|Drug|Tranylcypromine|standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks.
16346105|NCT00296686|Drug|Dextroamphetamine|up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone.
16346106|NCT00296686|Drug|Triiodothyronine|For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day).
16346107|NCT00296673|Device|Rehabilitation device|
16346108|NCT00296647|Drug|nicotine patch|Decreasing dosages from 21 to 7 mg over 12 week period
16346109|NCT00296647|Drug|nicotine patch|Decreasing dosage from 21 to 7 mg over 12 weeks
16346110|NCT00296647|Drug|nicotine lozenge|4 mg nicotine lozenge: dosage according to package directions for 16 weeks
16346111|NCT00296647|Drug|bupropion|dosage according to prescription directions: 12 weeks
16346112|NCT00296647|Drug|patch + lozenge|dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
16346113|NCT00296647|Drug|bupropion + lozenge|dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
16346114|NCT00296634|Drug|Aluminum hydroxide|Aluminum hydroxide adjuvant at 1200 mcg/mL.
16346115|NCT00296634|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)|Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant. All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection. Vaccine with adjuvant is a turbid liquid whitish-grey in color. Vaccine without adjuvant is essentially clear and slightly opalescent in color.
16346116|NCT00296621|Drug|L-Glutamine|L-Glutamine
16346117|NCT00296621|Drug|placebo|placebo
16346118|NCT00296608|Drug|fluorouracil|
16346119|NCT00296608|Drug|leucovorin calcium|
16346120|NCT00296608|Procedure|conventional surgery|
16346121|NCT00296608|Radiation|radiation therapy|
16346122|NCT00296595|Behavioral|Nutrition|
16346123|NCT00296582|Behavioral|Gastric Motor Function Measurement|
16346124|NCT00296569|Drug|MK0686|
16346125|NCT00296556|Drug|Rivenprost (drug)|
16346126|NCT00296530|Drug|fluticasone propionate/salmeterol|
16346127|NCT00296530|Drug|fluticasone propionate|
16346128|NCT00296530|Drug|montelukast|
16346129|NCT00296517|Drug|323U66 (Bupropion Hydrochloride Sustained Release)|Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
16346130|NCT00296517|Drug|Placebo|Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
16346131|NCT00296504|Drug|fosamprenavir (GW433908)|
16346132|NCT00296504|Drug|ritonavir|
16346133|NCT00296491|Drug|fluticasone propionate/salmeterol (FSC)|fluticasone propionate/salmeterol DISKUS combination
16346134|NCT00296491|Drug|montelukast (MON)|montelukast capsule
16346135|NCT00296491|Drug|fluticasone propionate (FP)|fluticasone propionate aqueous nasal spray
16357690|NCT00199017|Drug|Mercaptopurine|
16346136|NCT00296491|Drug|placebo nasal|vehicle placebo nasal spray
16346137|NCT00296491|Drug|ADVAIR DISKUS|ADVAIR DISKUS
16346138|NCT00296491|Drug|placebo capsule|placebo capsule
16346139|NCT00296491|Drug|placebo DISKUS|placebo DISKUS
16346140|NCT00296478|Drug|Endometrin|Endometrin 100mg BID x 10weeks
16346141|NCT00296478|Drug|Endometrin|Endometrin 100mg TID x 10weeks
16346142|NCT00296478|Drug|Crinone|Crinone QD x 10weeks
16346143|NCT00296465|Drug|Pulsatile gonadotropin-releasing hormone (GnRH)|Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
16346144|NCT00296465|Drug|Clomiphene Citrate|Oral clomiphene citrate (over encapsulated) for 5 days
16346145|NCT00296465|Drug|Placebo Pulsatile GnRH|Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
16346146|NCT00296465|Drug|Placebo Clomiphene Citrate|oral placebo clomiphene citrate for 5 days
16346147|NCT00296452|Behavioral|behavior|
16346148|NCT00296439|Behavioral|Behavior|
16346149|NCT00296426|Procedure|New technology - PAML|
16346150|NCT00296400|Drug|Rosuvastatin|
16346151|NCT00296400|Drug|Atorvastatin|
16346152|NCT00296387|Drug|Rosuvastatin|
16346153|NCT00296387|Drug|Atorvastatin|
16346154|NCT00296374|Drug|Rosuvastatin|10 mg oral dose administered once daily for 52 weeks
16346155|NCT00296374|Drug|Rosuvastatin|20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
16346156|NCT00296374|Drug|Atorvastatin|40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
16346157|NCT00296361|Drug|Tacrolimus|immunosuppression
16346158|NCT00296348|Drug|tacrolimus|immunosuppression
16346159|NCT00296348|Drug|mycophenolate mofetil|oral
16346160|NCT00296348|Drug|daclizumab|oral
16346161|NCT00296348|Drug|steroids|oral
16346162|NCT00296335|Drug|Mitomycin, doxifluridine and cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
16346163|NCT00296335|Drug|Mitomycin and doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
16346164|NCT00296322|Drug|cisplatin, mitomycin-C, doxifluridine|"Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
~iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)"
16346165|NCT00296309|Drug|Tacrolimus|Immunosuppression
16346166|NCT00296296|Drug|Cyclosporin|Dose adjustment to pre-established targets
16346167|NCT00296296|Drug|Tacrolimus|Dose adjustment to pre-established targets
16346168|NCT00296296|Behavioral|'Diabetes Education / Management'|therapeutic adjustment to target ADA criteria
16346169|NCT00296283|Behavioral|integrative behavior couples therapy|
16346170|NCT00296270|Behavioral|Memory for truth|
16346171|NCT00296257|Drug|SMP-114|
16346172|NCT00296244|Drug|Steroids|Patients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.
16346173|NCT00296244|Drug|Basiliximab|Basiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation.
16346174|NCT00296244|Drug|Tacrolimus|Tacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter.
16346175|NCT00296244|Drug|Enteric-coated Mycophenolic acid (EC-MPA)|This drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months.
16346176|NCT00296231|Other|Nasal high frequency ventilation|use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
16346177|NCT00296218|Drug|Irbesartan|
16346178|NCT00296205|Drug|Cyclophosphamide|
16346179|NCT00296192|Drug|Rotigotine nasal spray|Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries
16346180|NCT00296192|Other|Placebo|placebo nasal spray 1, 2 3, and 4 puffs
16346181|NCT00296179|Drug|zolpidem tartrate|
16346182|NCT00296166|Procedure|Catheter ablation|
16346183|NCT00296166|Procedure|Thoracoscopic epicardial ablation|
16346184|NCT00296153|Drug|Omega-3-acid ethyl esters 90|Omacor capsule 1000mg x 4 per day. Duration 12 weeks
16346185|NCT00296140|Behavioral|self management of PSD symptoms|
16346186|NCT00296140|Procedure|screening and treatment of PSD|
16346187|NCT00296127|Drug|Celecoxib|
16346188|NCT00296114|Procedure|Serum and DNA Samples|To collect serum and DNA samples from subjects
16346189|NCT00296101|Behavioral|Physical Activity|
16346190|NCT00296062|Biological|bevacizumab|Phase II: IV over 30-90 minutes on days 1 and 15 of each course.
16346265|NCT00295828|Other|Pegaptanib Sodium Injection/Panretinal Photocoagulation|Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.
16346266|NCT00295828|Procedure|Panretinal Photocoagulation (PRP)|Ocular Laser Procedure
16346191|NCT00296062|Drug|capecitabine|Phase I: oral capecitabine twice daily on days 1-7 and 15-21.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine (during both odd- and even-numbered courses) until the maximum tolerated dose (MTD) is determined.Phase II:receive capecitabine (at the MTD determined in phase I(odd-numbered courses)
16346192|NCT00296062|Drug|irinotecan hydrochloride|Phase I: irinotecan hydrochloride IV over 90 minutes on days 1 and 15 during course 1 and all subsequent odd-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Phase II: receive capecitabine (at the MTD determined in phase I) in combination with irinotecan hydrochloride (during odd-numbered courses)
16346193|NCT00296062|Drug|oxaliplatin|"Phase I: oxaliplatin IV over 2 hours on days 1 and 15 during course 2 and all subsequent even-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
~Phase II: oxaliplatin (during even-numbered courses) as in phase I"
16346194|NCT00296049|Drug|daptomycin|
16346195|NCT00296049|Drug|vancomycin|
16346196|NCT00296036|Dietary Supplement|pyridoxine hydrochloride|Given orally
16346197|NCT00296036|Drug|urea/lactic acid-based topical cream|Applied topically
16346198|NCT00296036|Other|placebo|Given orally or applied topically
16346199|NCT00296023|Biological|anti-thymocyte globulin|
16346200|NCT00296023|Biological|filgrastim|
16346201|NCT00296023|Biological|therapeutic allogeneic lymphocytes|
16346202|NCT00296023|Drug|busulfan|
16346203|NCT00296023|Drug|fludarabine phosphate|
16346204|NCT00296023|Drug|methotrexate|
16346205|NCT00296023|Drug|tacrolimus|
16346206|NCT00296023|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16346207|NCT00296023|Procedure|peripheral blood stem cell transplantation|
16346208|NCT00296010|Drug|cyclophosphamide|cyclophosphamide 50 mg/day orally continuously for 16 weeks
16346209|NCT00296010|Drug|methotrexate|methotrexate 2.5 mg twice a day orally on days 1 and 4 of every week for 16 weeks
16346210|NCT00296010|Drug|pegylated liposomal doxorubicin hydrochloride|Caelyx (R) (Doxil (R)) 20 mg/m2 iv x 8 doses (delivered every 2 weeks)
16346211|NCT00296010|Procedure|adjuvant therapy|
16346212|NCT00296010|Radiation|radiation therapy|Radiation therapy should be used according to institutional accepted guidelines. Radiation therapy to the conserved breast is recommended. Radiation therapy to the chest wall following mastectomy is optional (if given, it may also include nodal fields). Radiation therapy may be given either during operation or after all chemotherapy.
16346213|NCT00295997|Biological|anti-thymocyte globulin|
16346214|NCT00295997|Biological|filgrastim|
16346215|NCT00295997|Biological|graft-versus-tumor induction therapy|
16346216|NCT00295997|Biological|therapeutic allogeneic lymphocytes|
16346217|NCT00295997|Drug|busulfan|
16346218|NCT00295997|Drug|cyclophosphamide|
16346219|NCT00295997|Drug|fludarabine phosphate|
16346220|NCT00295997|Drug|methotrexate|
16346221|NCT00295997|Drug|mycophenolate mofetil|
16346222|NCT00295997|Drug|tacrolimus|
16346223|NCT00295997|Procedure|allogeneic bone marrow transplantation|
16346224|NCT00295997|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|
16346225|NCT00295997|Procedure|peripheral blood stem cell transplantation|
16346226|NCT00295984|Drug|nicotine|
16346227|NCT00295971|Biological|anti-thymocyte globulin|
16346228|NCT00295971|Biological|therapeutic allogeneic lymphocytes|
16346229|NCT00295971|Drug|fludarabine phosphate|
16346230|NCT00295971|Drug|thiotepa|
16346231|NCT00295971|Procedure|allogeneic bone marrow transplantation|
16346232|NCT00295971|Procedure|allogeneic hematopoietic stem cell transplantation|
16346233|NCT00295971|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16346234|NCT00295971|Radiation|total-body irradiation|
16346235|NCT00295958|Biological|LMB-2 immunotoxin|
16346236|NCT00295958|Biological|MART-1 antigen|
16346237|NCT00295958|Biological|gp100 antigen|
16346238|NCT00295958|Biological|incomplete Freund's adjuvant|
16346239|NCT00295945|Drug|fentanyl citrate|
16346240|NCT00295945|Drug|hydromorphone hydrochloride|
16346241|NCT00295945|Drug|ropivacaine hydrochloride|
16346242|NCT00295932|Biological|rituximab|Given IV
16346243|NCT00295932|Drug|bortezomib|Given IV
16346244|NCT00295932|Drug|cyclophosphamide|Given IV
16346245|NCT00295932|Drug|prednisone|Given orally
16346246|NCT00295919|Drug|fenretinide lipid matrix|
16346247|NCT00295919|Drug|ketoconazole|
16346248|NCT00295919|Other|laboratory biomarker analysis|
16346249|NCT00295919|Other|pharmacological study|
16346250|NCT00295906|Other|educational intervention|
16346251|NCT00295906|Other|internet-based intervention|
16346252|NCT00295893|Biological|trastuzumab|Given IV
16346253|NCT00295893|Drug|carboplatin|Given IV
16346254|NCT00295893|Drug|cyclophosphamide|Given IV
16346255|NCT00295893|Drug|docetaxel|Given IV
16346256|NCT00295893|Drug|doxorubicin hydrochloride|Given IV
16346257|NCT00295893|Drug|paclitaxel|Given IV
16346258|NCT00295880|Procedure|umbilical cord blood transplantation|The graft will be given by slow injection into each posterior iliac crest.
16346259|NCT00295867|Drug|Zoledronic Acid|Zoledronic acid is a new, highly potent, heterocyclic nitrogen-containing third generation bisphosphonate that has demonstrated 40- to 850- fold greater potency than pamidronate in preclinical models of bone resorption. The mechanism of action of nitrogen-containing bisphosphonates such as pamidronate and zoledronic acid appears to involve inhibition of the mevalonate pathway
16346260|NCT00295854|Drug|MN-001 BID|Eligible patients received 500 mg MN-001 bid
16346261|NCT00295854|Drug|MN-001|Eligible patients received 500 mg MN-001 once daily (qd)
16346262|NCT00295854|Drug|Placebo|Eligible patients received placebo
16346263|NCT00295841|Drug|clofarabine|
16346264|NCT00295841|Drug|cytarabine|
16346336|NCT00295243|Drug|Topotecan|
16357691|NCT00199017|Drug|Cytarabine|
16346267|NCT00295815|Drug|enzastaurin|1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
16346268|NCT00295815|Drug|lomustine|100-130 mg/m2, oral once, every 6 weeks until PD
16346269|NCT00295802|Device|Integrated Imaging High Intensity Focused Ultrasound|
16346270|NCT00295802|Device|Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)|Cryotherapy
16346271|NCT00295789|Drug|chemotherapy: Paclitaxel/Cisplatin|Drug: chemotherapy: Paclitaxel/Cisplatin
16346272|NCT00295789|Drug|chemotherapy: Paclitaxel/Carboplatin|Drug: chemotherapy: Paclitaxel/Carboplatin
16346273|NCT00295776|Drug|Lamictal in the treatment of Post-Herpetic Neuralgia|
16346274|NCT00295763|Drug|Thyrogen (thyrotropin alfa for injection)|"No reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days.
~For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO."
16346275|NCT00295750|Drug|Degarelix|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
16346276|NCT00295750|Drug|Degarelix|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
16346277|NCT00295750|Drug|Leuprolide 7.5 mg|Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
16346278|NCT00295737|Procedure|bronchoscopy, allergen/endotoxin instillation|
16346279|NCT00295724|Drug|Bicifadine|
16346280|NCT00295711|Drug|Bicifadine|
16346281|NCT00295698|Drug|Diethylcarbamazine|
16346282|NCT00295685|Drug|Antacids|
16346283|NCT00295672|Drug|Vinorelbine|
16346284|NCT00295646|Drug|tamoxifen|20 mg/d
16346285|NCT00295646|Drug|anastrozole|1 mg/d
16346286|NCT00295646|Drug|zoledronic acid|4 mg q6m
16346287|NCT00295633|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
16346288|NCT00295633|Drug|Saxagliptin|Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
16346289|NCT00295633|Drug|Placebo|Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
16346290|NCT00295633|Drug|pioglitazone|Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
16346291|NCT00295633|Drug|rosiglitazone|Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
16346292|NCT00295633|Drug|metformin|Tablets, Oral, 500-2500 mg, as needed (12 months LT)
16346293|NCT00295620|Drug|Anastrozole|1mg tablet daily
16346294|NCT00295607|Drug|Tacrolimus|immunosuppression
16346295|NCT00295607|Drug|steroids, monoclonal anti-IL2R antibody|immunosuppression
16346296|NCT00295594|Drug|tacrolimus|Immunosuppression
16346297|NCT00295581|Drug|PpPfs25/ISA51 & ScPvs25/ISA51|
16346298|NCT00295555|Drug|Effects of doxazosin on morning surge in diabetic patients|
16346299|NCT00295542|Device|Ambulatory blood pressure monitoring|Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
16346300|NCT00295542|Procedure|Chronotherapy, timing of antihypertensive medication|Comparison of effects of awakening versus bedtime dosing
16346301|NCT00295542|Drug|ACEI (including spirapril, enalapril, quinapril, lisinopril)|Treatment at awakening versus bedtime
16346302|NCT00295542|Drug|ARB (including valsartan, telmisartan, olmesartan)|Treatment at awakening versus bedtime
16346303|NCT00295542|Drug|beta blockers (including nebivolol, atenolol, carvedilol)|Treatment at awakening versus bedtime
16346304|NCT00295542|Drug|diuretics (torasemide, indapamide, HTCZ) and doxazosin|Treatment at awakening versus bedtime
16346305|NCT00295542|Procedure|Combination therapy in essential hypertension|Treatment at awakening versus bedtime
16346306|NCT00295529|Behavioral|Multifaceted educational intervention|Educational materials available at end of study
16346307|NCT00295516|Procedure|Fetal Middle Cerebral Artery Doppler measurement|
16346308|NCT00295503|Drug|bevacizumab|15 mg/kg IV every 3 weeks
16346309|NCT00295503|Drug|cisplatin|75 mg/m2 IV every 3 weeks
16346310|NCT00295503|Drug|pemetrexed|500 mg/m2 every 3 weeks
16346311|NCT00295490|Drug|Devil Claw|Dose ranging study so will elucidate dose Frequency is four times daily
16346312|NCT00295490|Drug|Placebo|Placebo has same dosing freq as for active intervention and for same time period
16346313|NCT00295477|Genetic|VRX496|In Step 1 of the protocol, each subject will receive up to 2 cycles of VRX496. Each treatment cycle consists of 3 infusions of VRX496.
16346314|NCT00295464|Drug|Betamethasone sodium phos (drug)|
16346315|NCT00295438|Device|Robot-Based Tele-Echography (TER)|Robot-Based Tele-Echography, ultrasound performed by the radiologist
16346316|NCT00295438|Device|ultrasound method FAST|FAST,ultrasound performed by the emergency doctor
16346317|NCT00295425|Drug|Cyclosporine A versus mycophenolate mofetil for psoriasis|
16346318|NCT00295412|Drug|quetiapine (drug)|
16346319|NCT00295399|Device|The Jerusalem Telerehabilitation System|
16346320|NCT00295386|Behavioral|Cognitive behavior therapy (CBT)|
16346321|NCT00295386|Drug|Zopiclone|
16346322|NCT00295373|Drug|Rosuvastatin|
16346323|NCT00295373|Behavioral|Exercise Training|
16346324|NCT00295360|Behavioral|no intervention, pathophysiological study|
16346325|NCT00295347|Drug|Spironolactone|
16346326|NCT00295347|Drug|fludrocortisone|
16346327|NCT00295347|Drug|escitalopram|
16346328|NCT00295334|Drug|alcohol|
16346329|NCT00295308|Drug|Clonidine|clonidine up to 0.3 mg/day oral
16346330|NCT00295308|Drug|Placebo|oral capsules daily
16346331|NCT00295295|Device|High frequency, low magnitude vibration|High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
16346332|NCT00295295|Other|Standing|Standing 10 min/day
16346333|NCT00295282|Drug|MDX-1100 (anti-CXCL10 human monoclonal antibody)|Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100.
16346334|NCT00295269|Drug|Mythylprednisolone|
16346335|NCT00295256|Behavioral|nurse case manager|
16346337|NCT00295230|Procedure|PSV+VG mode versus SIMV+VG mode|fully assisted mechanical ventilation versus assistance on only a select number of breaths
16346338|NCT00295217|Device|ExAblate 2000|
16346339|NCT00295191|Procedure|high-flux membrane|high-flux dialyser
16346340|NCT00295191|Procedure|low-flux membrane|low-flux dialyser
16346341|NCT00295191|Procedure|conventional dialysate|conventional dialysate
16346342|NCT00295191|Procedure|ultrapure dialysate|ultrapure dialysate
16346343|NCT00295178|Drug|Daptomycin|
16346344|NCT00295178|Drug|Vancomycin|
16346345|NCT00295165|Drug|Sargramostim (Leukine)|Sargramostim 6 mcg/kg subcutaneously once daily
16346346|NCT00295165|Drug|Placebo|Placebo subcutaneously once daily
16346347|NCT00295152|Behavioral|community occupational therapy in dementia|
16346348|NCT00295139|Behavioral|Behavioral Treatment for Substance Abuse in SPMI (BTSAS)|Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes.
16346349|NCT00295139|Behavioral|Supportive Treatment in Addiction Recovery (STAR)|Manualized substance abuse treatment as usual
16346350|NCT00295139|Behavioral|Critical Time Intervention (CTI)|Case management component
16346351|NCT00295126|Procedure|cellular therapy : Autologous platelet concentrate (APC)|
16346352|NCT00295113|Procedure|EFR|
16346353|NCT00295100|Drug|Tamoxifen|
16346354|NCT00295074|Procedure|neuropsychologic testing|
16346355|NCT00295061|Drug|Alpha-1 MP|alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
16346356|NCT00295061|Drug|alpha-1 proteinase inhibitor (human)|Prolastin
16346357|NCT00295048|Behavioral|Computer Assisted Cognitive Remediation (CACR)|
16346358|NCT00295035|Drug|CELECOXIB|
16346359|NCT00295035|Drug|CURCUMIN|
16346360|NCT00295022|Drug|Placebo|"Pharmaceutical form: Over-encapsulated tablet
~Route of administration: Oral use"
16346361|NCT00295022|Drug|Montelukast|"Pharmaceutical form: Over-encapsulated tablet
~Concentration: 10 mg
~Route of administration: Oral use"
16346362|NCT00295022|Drug|Levocetirizine|"Pharmaceutical form: Over-encapsulated tablet
~Concentration: 5 mg
~Route of administration: Oral use"
16346363|NCT00295009|Device|ProDisc|Total disc replacement with ProDisc
16346364|NCT00295009|Procedure|Spinal Fusion|A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
16346365|NCT00294996|Drug|Myocet|
16346366|NCT00294944|Drug|Idazoxan|
16346367|NCT00294931|Drug|irinotecan|
16346368|NCT00294931|Drug|carboplatin|
16346369|NCT00294931|Drug|bevacizumab|
16346370|NCT00294918|Drug|Serostim®|Serostim® will be administered subcutaneously at a dose of 1 mg to subjects who had encountered toxicity during the antecedent protocol (Study 22388) whereas, other subjects will be randomized in 1:1 ratio, to receive either 2 milligram (mg) or 4 mg (on a weight adjusted basis) daily, starting from Day 1 of Week 1 up to Week 12 (Period 1). During Period 1, subjects who encounter toxicity will receive 1 mg Serostim® subcutaneously, daily for Period 2, starting from Day 1 of Week 13, whereas other subjects will be randomized in a 1:1 ratio to receive either 2 mg or 1 mg (on a weight adjusted basis) up to Week 36.
16346371|NCT00294905|Behavioral|Implementation of a combined smoking cessation strategy|
16346372|NCT00294892|Drug|carbamazepine and nevirapine|Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
16346373|NCT00294892|Drug|Nevirapine|Nevirapine 200mg is taken prior to delivery during labor.
16346374|NCT00294879|Procedure|pressure support ventilation at 0, 5, and 10% IRT|
16346375|NCT00294866|Drug|Paricalcitol|Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.
16346376|NCT00294853|Procedure|MDCT calcium score|
16346377|NCT00294840|Device|PET-CT|
16346378|NCT00294827|Procedure|Liver transplantation and colo-rectal cancer|Liver transplantation
16346379|NCT00294814|Device|Proximal anastomosis using Heartstring anastomotic device|
16346380|NCT00294801|Drug|flex-a-new (food supplement)|
16346381|NCT00294788|Biological|Fluvax|
16346382|NCT00294788|Drug|PCC® (Lactobacillus fermentum VRI 003)|
16346383|NCT00294775|Drug|Candesartan|
16346384|NCT00294762|Drug|Tarceva|oral tablet
16346385|NCT00294762|Drug|carboplatin|IV
16346386|NCT00294762|Drug|paclitaxel|IV
16346387|NCT00294749|Drug|Ciprofloxacine|
16346388|NCT00294736|Drug|Tarceva|Dose Escalation: 150-350+ mg/day
16346389|NCT00294723|Drug|liraglutide|1.8 mg for s.c. (under the skin) injection
16346390|NCT00294723|Drug|glimepiride|8 mg capsule
16346391|NCT00294723|Drug|liraglutide|1.2 mg for s.c. (under the skin) injection
16346392|NCT00294723|Drug|placebo|Glimepiride placebo, 8mg capsule
16346393|NCT00294723|Drug|placebo|Liraglutide placebo, 200 mcl
16346394|NCT00294723|Drug|placebo|Liraglutide placebo, 300 mcl
16346395|NCT00294710|Drug|Aliskiren|
16346440|NCT00294307|Behavioral|Resource Nurse Care (RNC)|Standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization (ASC) and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];.
16346499|NCT00293787|Other|Timolol Vehicle|Placebo
16346739|NCT00291720|Drug|Placebo|matching placebo
16346396|NCT00294684|Drug|Corticosteroids|"Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.
~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
16346397|NCT00294684|Drug|Placebo|"Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:
~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
16346398|NCT00294671|Drug|diflunisal|given twice daily for 24 months
16346399|NCT00294671|Other|placebo|an inactive substance given twice daily for 24 months
16346400|NCT00294658|Procedure|thymectomy plus prednisone|The thymectomy will be performed as soon as possible after randomization.
16346401|NCT00294658|Drug|prednisone alone|Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
16346402|NCT00294645|Other|Transtelephonic monitoring (TTM)|TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.
16346403|NCT00294645|Other|Medtronic CareLink® Network|Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.
16346404|NCT00294632|Drug|Lenalidomide|Starting Dose 10 mg By Mouth Daily on Days 1-21
16346405|NCT00294632|Drug|Rituximab|375 mg/m^2 By Vein Weekly for 4 Weeks
16346406|NCT00294619|Drug|growth hormone|subcutaneous injection, once-weekly
16346407|NCT00294606|Drug|Comparison of Effects of Phenylephrine and Norepinephrine|
16346408|NCT00294593|Drug|folinic acid|
16346409|NCT00294580|Drug|Maloprim|
16346410|NCT00294567|Drug|Calcium channel blockers (amlodipine, azelnidipine)|Drug: amlodipine Drug: azelnidipine
16346411|NCT00294554|Drug|Memantine|Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.
16346412|NCT00294554|Drug|Placebo Oral Tablet|Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.
16346413|NCT00294541|Drug|ICA-17043|
16346414|NCT00294528|Device|Nexgen LPS-flex and AGC|
16346415|NCT00294515|Drug|Valganciclovir|900 mg orally daily for up to 100 days
16346416|NCT00294515|Drug|Valganciclovir|900 mg orally daily for up to 200 days
16346417|NCT00294502|Drug|Gentamycin/citrate, Minocycline/EDTA|
16346418|NCT00294476|Drug|IVIG|
16346419|NCT00294476|Procedure|Biological Therapy|
16346420|NCT00294463|Drug|Tibolone|
16346421|NCT00294463|Drug|Estradiol|
16346422|NCT00294463|Drug|Estradiol + Medroxy Progesterone Acetate|
16346423|NCT00294450|Device|Fistula Pouching System|3 different sizes of fistula pounching system
16346424|NCT00294437|Drug|Zometa|Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
16346425|NCT00294424|Procedure|Short waiting time|
16346426|NCT00294424|Procedure|Non-fixed waiting time|
16346427|NCT00294411|Procedure|elective cesarean section|
16346428|NCT00294398|Other|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
16346429|NCT00294398|Other|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
16346430|NCT00294385|Drug|Docetaxel|
16346431|NCT00294385|Drug|Gemcitabine, Docetaxel|Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.
16346432|NCT00294385|Drug|Docetaxel|rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
16346433|NCT00294372|Drug|BILR 355 BS|
16346434|NCT00294372|Drug|Placebo|
16346435|NCT00294359|Drug|Mitomycin C; Capecitabine; Bevacizumab|
16346436|NCT00294346|Drug|AV608|
16346437|NCT00294320|Drug|Aldara (Imiquimod)|250mg of Imiquimod cream for application once daily 3 times per week.
16346438|NCT00294320|Other|Vehicle cream|250mg vehicle cream for application once daily 3 times per week.
16346439|NCT00294307|Behavioral|Augmented Standard Care (ASC)|Standard hospital care and, if referred, home care plus early identification of CI during the patients' hospitalization by trained research assistants with immediate verbal feedback and documentation to patients' primary nurses, attending physicians and discharge planners [low intensity];
16346498|NCT00293787|Drug|Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16346441|NCT00294307|Behavioral|Advanced Practice Nurse Care (APNC)|Standard hospital care plus ASC and transitional care starting in the hospital and substituting for standard home care and provided by Advanced Practice Nurses (APNs) with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].
16346442|NCT00294294|Biological|Prevenar|
16346443|NCT00294294|Biological|Infanrix hexa|
16346444|NCT00294281|Device|Vagus Nerve Stimulation (VNS) Therapy|The VNS Therapy System Pulse Generator is an implantable, multi-programmable bipolar pulse generator. The pulse generator will deliver electrical signals to the vagus nerve via bipolar leads. A programming wand and software system enable non-invasive programming, functional assessments, interrogation, and data retrieval.
16346445|NCT00294268|Behavioral|cognitive behavioural therapy|20 weekly sessions of CBT integrated with motivational enhancement strategies
16346446|NCT00294255|Drug|Risperidone|risperidone will be administered 1-3mg pills, each night, for up to 20 weeks
16346447|NCT00294242|Procedure|membrane sweeping|
16346448|NCT00294229|Procedure|manipulative therapy|
16346449|NCT00294216|Drug|Omega-3-acid ethyl ester 90 (n-3 PUFA)|
16346450|NCT00294203|Drug|Epoetin Alfa group|Patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.
16346451|NCT00294203|Other|Placebo group|Patients enrolled in the study will be randomized to receive either 40,000 units of placebo (saline) on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.
16346452|NCT00294190|Drug|Topotecan|Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
16346453|NCT00294177|Device|atomic force microscopy|
16346454|NCT00294177|Device|dual polarisation interferometry|
16346455|NCT00294164|Drug|Serostim®|Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.
16346456|NCT00294164|Drug|Placebo|Matching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.
16346457|NCT00294151|Procedure|Vertebroplasty|
16346458|NCT00294125|Drug|Flavocoxid|Daily flavocoxid for 12 weeks
16346459|NCT00294125|Drug|Placebo|Daily placebo for 12 weeks
16346460|NCT00294112|Drug|Prochymal™ adult human mesenchymal stem cells|Cells in plasmalyte and containing dimethylsulfoxide
16346461|NCT00294112|Drug|adult human mesenchymal stem cells|two infusions, one week apart, each comprising adult human mesenchymal stem cells
16346462|NCT00294099|Biological|Aluminum hydroxide|Aluminum hydroxide adjuvant.
16346463|NCT00294099|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28.
16346464|NCT00294086|Drug|valsartan 160 mg|
16346465|NCT00294086|Drug|valsartan 160 mg BID|
16346466|NCT00294073|Procedure|Fascia Iliaca Block|
16346467|NCT00294073|Procedure|Femoral Block (with stimulating catheter)|
16346468|NCT00294073|Procedure|Femoral Block (without stimulating catheter)|
16346469|NCT00294047|Biological|Cervarix|Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
16346470|NCT00294047|Biological|Placebo control|Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
16346471|NCT00294034|Device|Pacemaker|
16346472|NCT00294008|Drug|Risperdal Consta|flexible dosage for 24 months
16346473|NCT00293995|Procedure|Laparaoscopic repair, with closure of contralateral patent processus vaginalis|
16346474|NCT00293995|Procedure|open repair|
16346475|NCT00293982|Behavioral|Physician knowledge of parental expectations for the visit|
16346476|NCT00293969|Drug|Morphine 0.1mg/kg versus morphine 0.15 mg/kg|
16346477|NCT00293943|Procedure|Pulmonary vein ablation|
16346478|NCT00293930|Drug|Tacrolimus|
16346479|NCT00293917|Drug|Tacrolimus Cream|
16346480|NCT00293904|Biological|CYT005-AllQbG10|
16346481|NCT00293891|Drug|Tacrolimus Cream|
16346482|NCT00293878|Drug|Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)|
16346483|NCT00293865|Procedure|sentinel node|detection of the sentinel node in breast cancer
16346484|NCT00293865|Procedure|GAS|
16346485|NCT00293852|Procedure|Outpatient clinic follow-up|
16346486|NCT00293839|Drug|oxybutynin chloride|
16346487|NCT00293826|Drug|AMG 108|50mg via SC (subcutaneous) injection every 4 weeks
16346488|NCT00293826|Drug|AMG 108|250mg via SC (subcutaneous) injection every 4 weeks
16346489|NCT00293826|Drug|AMG 108|125mg via SC (subcutaneous) injection every 4 weeks
16346490|NCT00293826|Drug|Placebo|Placebo via SC (subcutaneous) injection every 4 weeks
16346491|NCT00293813|Drug|Alendronate|Alendronate 70 mg PO QW
16346492|NCT00293813|Drug|Denosumab|denosumab 60 mg SC q 6 mos
16346493|NCT00293813|Drug|Placebo|Placebo for alendronate and placebo for denosumab
16346494|NCT00293800|Drug|Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16346495|NCT00293800|Drug|Latanoprost 0.005% Ophthalmic Solution (XALATAN)|Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
16346496|NCT00293800|Drug|Timolol 0.5% Ophthalmic Solution|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
16346497|NCT00293800|Other|Timolol Vehicle|Placebo
16346500|NCT00293787|Drug|Latanoprost 0.005% Ophthalmic Solution (XALATAN)|Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
16346501|NCT00293787|Drug|Timolol Maleate Ophthalmic Solution 0.5%|Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
16346502|NCT00293761|Drug|Travoprost, Investigational|One drop in study eye once daily for 13 days
16346503|NCT00293761|Drug|Travoprost (TRAVATAN)|One drop in study eye once daily for 13 days
16346504|NCT00293735|Drug|labetalol (seizure prevention)|"20mg IV (can be increased to an escalating dose of maximum of 80 mg (20mg, 40 mg, 80 mg q 20min) Cumulative max of 240 mg.
~20mg labetalol PO every 6 hours"
16346505|NCT00293735|Drug|MgSO4 (seizure prevention)|4-6g bolus over 20 minutes; 1-2 grams/hr Discontinued 24 hours after delivery.
16346506|NCT00293722|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16346507|NCT00293709|Drug|etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16346508|NCT00293696|Drug|bicalutamide (Casodex), goserelin (Zoladex)|
16346509|NCT00293683|Device|Insorb absorbable skin staple|
16346510|NCT00293670|Drug|Goserelin (Zoladex)|
16346511|NCT00293657|Drug|Lornoxicam 8 mg|
16346512|NCT00293657|Drug|Lornoxicam 16 mg|
16346513|NCT00293657|Drug|Placebo|
16346514|NCT00293644|Drug|Diclectin®|Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.
16346515|NCT00293631|Drug|Lornoxicam 8 mg|
16346516|NCT00293631|Drug|Lornoxicam 16 mg|
16346517|NCT00293631|Drug|Ketorolac 30 mg|
16346518|NCT00293631|Drug|Placebo|
16346519|NCT00293618|Device|Automatic Risk Presentation in the operating room|Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
16346520|NCT00293618|Other|Education|Specific information is provided to the intervention group: about PONV, about the prediction model. While the Usual Care group only receives information about the study purposes
16346521|NCT00293618|Other|Feedback|Feedback about the physician's personal performance on prevention of PONV
16346522|NCT00293605|Procedure|Total Hip Replacement|Implantation of one of 3 stem designs
16346523|NCT00293592|Drug|Dexamethasone|1 mg per kg as a single dose before initiation of cardiopulmonary bypass
16346524|NCT00293579|Drug|Pemetrexed|500 mg/m2 IV every 3 weeks for 6 cycles
16346525|NCT00293553|Procedure|Electronic Barostat|
16346526|NCT00293540|Procedure|oophorectomy|Excision of an ovary
16346527|NCT00293540|Drug|Tamoxifen|20 mg orally every day
16346528|NCT00293527|Drug|Interferon Alpha-2b|
16346529|NCT00293514|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|
16346530|NCT00293501|Drug|tinzaparin sodium|
16346531|NCT00293488|Drug|polyamine analogue PG11047|
16346532|NCT00293475|Drug|Carboplatin|Given IA
16346533|NCT00293475|Drug|Mannitol|Given IA
16346534|NCT00293475|Drug|Methotrexate|Given IA
16346535|NCT00293475|Other|Quality-of-Life Assessment|Ancillary studies
16346536|NCT00293475|Biological|Rituximab|Given IV
16346537|NCT00293475|Drug|Sodium Thiosulfate|Given IV
16346538|NCT00293462|Biological|sargramostim|
16346539|NCT00293462|Other|oral salt and soda mouthwash|Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.
16346540|NCT00293436|Drug|celecoxib|
16346541|NCT00293436|Drug|erlotinib hydrochloride|
16346542|NCT00293436|Procedure|adjuvant therapy|
16346543|NCT00293423|Biological|HSPPC-96|25 mcg
16346544|NCT00293423|Procedure|Standard Surgical Resection|Patients will undergo standard surgical resection of intracranial tumor
16346545|NCT00293410|Drug|clofarabine|
16346546|NCT00293410|Drug|cyclophosphamide|
16346547|NCT00293397|Device|Drug-eluting beads loaded with doxorubicin hydrochloride|Doxorubicin eluting beads
16346548|NCT00293384|Drug|Aprepitant|Aprepitant 80mg once daily in the morning on days 2 and 3
16346549|NCT00293384|Drug|Cyclophosphamide|Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
16346550|NCT00293384|Drug|Dexamethasone|Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
16346551|NCT00293384|Drug|Granisetron hydrochloride|Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
16346552|NCT00293371|Drug|docetaxel|
16346553|NCT00293371|Drug|prednisone|
16346554|NCT00293371|Drug|vatalanib|
16346555|NCT00293358|Drug|carboplatin|
16346556|NCT00293358|Drug|cisplatin|
16346557|NCT00293358|Drug|etoposide phosphate|
16346558|NCT00293358|Drug|ifosfamide|
16346559|NCT00293358|Procedure|adjuvant therapy|
16346560|NCT00293358|Procedure|conventional surgery|
16346561|NCT00293358|Procedure|neoadjuvant therapy|
16346562|NCT00293358|Radiation|radiation therapy|
16346563|NCT00293345|Drug|gemcitabine hydrochloride|
16346564|NCT00293345|Drug|triapine|
16346565|NCT00293332|Biological|bevacizumab|Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.
16346566|NCT00293332|Drug|carboplatin|Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.
16346567|NCT00293332|Drug|docetaxel|Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.
16346568|NCT00293332|Procedure|conventional surgery|Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.
16346569|NCT00293319|Biological|filgrastim|
16346570|NCT00293319|Radiation|iobenguane I 131|
16346736|NCT00291733|Drug|Levetiracetam|500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
16346737|NCT00291733|Drug|Placebo|Placebo tabl
16346860|NCT00290693|Drug|Docetaxel|30 mg/m2, IV, days 1 and 8 every 3 weeks
16346571|NCT00293293|Other|healing touch|The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.
16346572|NCT00293293|Other|massage therapy|Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.
16346573|NCT00293293|Other|hypnosis|Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.
16346574|NCT00293293|Drug|Standard chemotherapy|Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.
16346575|NCT00293280|Drug|lomustine|
16346576|NCT00293267|Drug|raltegravir potassium|Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
16346577|NCT00293267|Drug|Comparator: Placebo|Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
16346578|NCT00293254|Drug|raltegravir potassium|Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
16346579|NCT00293254|Drug|Comparator: placebo|Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.
16346580|NCT00293241|Device|Managed Ventricular Pacing programmed ON/OFF|Device programming
16346581|NCT00293228|Drug|Isoniazid|Isoniazid (5mg per kg up to 300 mg daily for 6 months)
16346582|NCT00293228|Drug|isoniazid|isoniazid (5mg per kg up to 300 mg daily for 6 months
16346583|NCT00293215|Drug|111-Indium-CMD-193|111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes.
16346584|NCT00293215|Drug|CMD-193|CMD-193 was administered as an IV infusion over 60 (± 5) minutes.
16346585|NCT00293202|Drug|Etanercept|Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week
16346586|NCT00293202|Drug|Placebo|Hemodialysis patients will receive Saline by subcutaneous injection twice a week
16346587|NCT00293176|Drug|Donepezil Hydrochloride|Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.
16346588|NCT00293176|Drug|Placebo|Subjects will receive matching placebo tablets.
16346589|NCT00293163|Device|Hylaform, Hylaform Plus (hylan B gel)|
16346590|NCT00293150|Drug|Eplerenone|
16346591|NCT00293124|Drug|Glivec|400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing
16346592|NCT00293111|Drug|SDX-101 (R-Etodolac)|
16346593|NCT00293098|Drug|deferiprone|oral administration of 75 mg/kg/day in three divided doses, usually in combination with deferoxamine therapy
16346594|NCT00293085|Drug|Docetaxel|
16346595|NCT00293085|Drug|Docetaxel|"Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles.
~Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities.
~Premedication:
~Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion.
~All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion.
~Hyperhydration Patients will require intravenous hydration according to institutional guidelines."
16346596|NCT00293072|Drug|Rituximab|
16346597|NCT00293059|Drug|Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle)
16346598|NCT00293059|Drug|Placebo|Matching placebo to be taken orally daily.
16346599|NCT00293046|Biological|ALK Grass tablet - use of compliance device|
16346600|NCT00293033|Drug|BEMA™|BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
16346601|NCT00293033|Drug|Placebo|
16346602|NCT00293020|Drug|BEMA Fentanyl|buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily
16346603|NCT00292994|Behavioral|Exercise|
16346604|NCT00292994|Behavioral|Weight Loss|
16346605|NCT00292981|Drug|C1 Esterase Inhibitor|Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
16346606|NCT00292968|Behavioral|Computer based care|
16346607|NCT00292968|Behavioral|Telephone counseling|
16346608|NCT00292968|Behavioral|Group visits|
16346609|NCT00292968|Behavioral|Usual care|
16346610|NCT00292955|Drug|Cetuximab|monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.
16346611|NCT00292942|Drug|Intravenous Artesunate|Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)
16346612|NCT00292942|Drug|Placebo|Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.
16346613|NCT00292929|Drug|Intravenous artesunate|
16346614|NCT00292916|Behavioral|whole body vibration|
16346615|NCT00292916|Behavioral|resistance exercise|
16346616|NCT00292916|Behavioral|"wellness"|
16346738|NCT00291720|Drug|Spironolactone|All patients receive a 4 week open labeled run in phase of 25mg spironolactone daily after which they are randomized to continue or receive matched placebo for 8 months.
16346861|NCT00290680|Drug|bortezomib|
16346617|NCT00292903|Behavioral|Brief interpersonal psychotherapy|IPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment.
16346618|NCT00292903|Behavioral|Facilitated referral for treatment as usual|F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.
16346619|NCT00292890|Device|insulin needle|
16346620|NCT00292877|Drug|SB-240563 (Mepolizumab)|
16346621|NCT00292864|Drug|SNS-032 Injection|
16346622|NCT00292838|Drug|fluticasone 25, 50, 100, 200 mcg|
16346623|NCT00292825|Device|Pacemaker treatment, pacemaker programmed as active = CLS|Pacemaker treatment with closed loop function(CLS)
16346624|NCT00292825|Device|Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)|pacemaker treatment as VVI 30 bpm
16346625|NCT00292812|Drug|Nutritional supplementation (nucleotides)|
16346626|NCT00292799|Drug|Orlistat Vs Metformin|
16346627|NCT00292786|Behavioral|Walking Practice with Functional Electrical Stimulation|
16346628|NCT00292786|Behavioral|Walking Practice|
16346629|NCT00292773|Procedure|weight reduction minimal access surgery|Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line with the current recommendation for gastric surgery according to NICE guidelines i.e. patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be reviewed monthly for six months.
16346630|NCT00292760|Drug|Alemtuzumab|
16346631|NCT00292760|Drug|Methyprednisolone|
16346632|NCT00292747|Drug|Drotaverine|
16346633|NCT00292747|Drug|Drotaverine Placebo|
16346634|NCT00292747|Drug|Ibuprofen|
16346635|NCT00292747|Drug|Ibuprofen Placebo|
16346636|NCT00292734|Drug|Zolpidem|
16346637|NCT00292721|Drug|Celecoxib|celecoxib: loading and maintenance for 6 months
16346638|NCT00292708|Drug|Cefmetazole (drug)|
16346639|NCT00292695|Other|VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT|"IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1
~DVIP: (Q4W, POST-RT) X 2 Dexamethosone 20 mg/m2/d iv D1-4 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-4 Ifosfamide 1.2 gm/m2/d ivd 2 hr D1-4 Mesna 240 mg/m2/d iv at 0, 4, 8 hr D1-4 Cisplatin 20 mg/m2 ivd 1 hr D1-4 G-CSF 250ug subcut D 9-12"
16346640|NCT00292656|Procedure|NAET|
16346641|NCT00292591|Drug|cholecalciferol (vitamin D3)|randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
16346642|NCT00292591|Drug|cholecalciferol|comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
16346643|NCT00292578|Procedure|NAET Testing Modalities|
16346644|NCT00292552|Other|Novel endpoint determination|Novel endpoint determination
16346645|NCT00292539|Device|Any pacemaker with right ventricular pacing option|
16346646|NCT00292526|Drug|Enalapril|enalapril orally administered
16346647|NCT00292513|Device|standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)|
16346648|NCT00292500|Device|Automated distal anastomotic device|CABG
16346649|NCT00292487|Drug|Iopamidol 370 mgI/mL|
16346650|NCT00292474|Device|percutaneous coronary intervention|
16346651|NCT00292461|Drug|Zonisamide|Tablet once or twice daily orally for 16 weeks
16346652|NCT00292461|Drug|Lamotrigine|Tablet once daily orally for 16 weeks
16346653|NCT00292448|Drug|Ba 679 BR Respimat|
16346654|NCT00292448|Drug|Tiotropium (Spiriva) inhalation capsule 18 ug|
16346655|NCT00292435|Drug|Read vine leaf extract (AS 195)|
16346656|NCT00292422|Drug|BG9924|
16346657|NCT00292409|Drug|Aripiprazole|
16346658|NCT00292396|Drug|Anti IL-12 monoclonal antibody/ABT-874|Please see Arm Description for intervention description and details.
16346659|NCT00292396|Drug|placebo|12 doses
16346660|NCT00292383|Procedure|Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR|
16346661|NCT00292370|Drug|Open Label (OL) Paroxetine|Open-label Paroxetine
16346662|NCT00292370|Drug|Placebo|Double-blind placebo taken with OL paroxetine
16346663|NCT00292370|Drug|Quetiapine|Double-blind quetiapine taken with OL paroxetine
16346664|NCT00292357|Procedure|Application of autologous bone marrow|
16346665|NCT00292344|Drug|Rifaximin and loperamide|
16346666|NCT00292331|Procedure|cyanoacrylate injection to treat gastric variceal hemorrhage|
16346667|NCT00292318|Behavioral|Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study|Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
16346668|NCT00292318|Behavioral|control group|Medical counseling and ano-sphinctal exercises.
16346669|NCT00292305|Procedure|Percutaneous coronary intervention|Implantation of coronary stent in bifurcation lesions
16346670|NCT00292292|Device|Lumbar Artificial Disc|Insertion of the Kineflex Lumbar ArtificialDisc
16346671|NCT00292292|Device|Charite Artificial Disc|Insertion of the Charite
16346672|NCT00292279|Drug|Omega-3 fish oil emulsion (Omegaven )|Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day
16346673|NCT00292279|Drug|long-chain triglyceride|the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
16346674|NCT00292266|Drug|Rebif®|Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.
16346675|NCT00292266|Drug|Avonex®|Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.
16346676|NCT00292253|Device|Rebif® via Rebiject™Mini|Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
16346677|NCT00292253|Device|Rebif® via manual injections|Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.
16346678|NCT00292240|Behavioral|Brief motivational substance use intervention|
16346679|NCT00292227|Drug|Rotigotine|"Rotigotine patch applied once daily for a 24-hour period.
~Rotigotine dose schedule (patch application days):
~Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;"
16346680|NCT00292227|Other|Placebo|"Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days):
~Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;"
16346681|NCT00292227|Drug|Moxifloxacin infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39
16346682|NCT00292227|Other|Placebo infusion|Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39
16346683|NCT00292227|Other|Placebo infusion|Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39
16346684|NCT00292214|Drug|Paracetamol (acetaminophen)|
16346685|NCT00292201|Drug|Atorvastatin|The treatment group will receive Atorvastatin 80 mg po once per day for 4 weeks. The placebo group will receive an identical placebo pill po once per day for 4 weeks.
16346686|NCT00292188|Drug|pregabalin|pregabalin
16346687|NCT00292188|Drug|Placebo|placebo
16346688|NCT00292175|Procedure|Narrow Band Imaging|
16346689|NCT00292175|Procedure|colonoscopy|
16346690|NCT00292162|Procedure|radiofrequency ablation|isolation of the pulmonary veins with radiofrequency ablation (RFA)
16346691|NCT00292162|Drug|ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril|Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
16346692|NCT00292162|Drug|Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol|Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
16346693|NCT00292162|Drug|Aldosterone Antagonists - spironolactone|Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.
16346694|NCT00292123|Drug|Methadone|
16346695|NCT00292123|Behavioral|Contingency Management|
16346696|NCT00292110|Drug|Methadone|100 mg/day orally
16346697|NCT00292110|Behavioral|Contingency Management|Incentives given for cocaine abstinence
16346698|NCT00292110|Drug|Methadone dose|flexible methadone dosing to 190 mg/day daily orally
16346699|NCT00292110|Behavioral|Contingency Management/Noncontingent Incentives|Incentives given independent of drug use
16346700|NCT00292097|Procedure|Early tracheostomy|early conversion - less than or equal to 72 hours
16346701|NCT00292097|Procedure|Late tracheostomy|Late conversion (10-14 days)
16346702|NCT00292084|Drug|Celgosivir|
16346703|NCT00292071|Drug|caspofungin acetate|(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
16346704|NCT00292058|Device|Videoconference equipment (telepsychiatry)|
16346705|NCT00292045|Biological|NY-ESO-1 protein/CpG 7909|Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle).
16346706|NCT00292019|Procedure|Laparoscopic|Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
16346707|NCT00292006|Device|Computerized tomography|
16346708|NCT00291980|Biological|HB-AS02V vaccine|HB-AS02V (20µg HBsAg) will be administered at Month 0
16346709|NCT00291980|Biological|HBVAXPRO vaccine|HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0
16346710|NCT00291967|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
16346711|NCT00291954|Biological|HB-AS02V|HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
16346712|NCT00291954|Biological|HBVAXPRO vaccine|HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1
16346713|NCT00291941|Biological|Henogen HBV vaccine|20µg, Month 0, 2 and 6
16346714|NCT00291941|Biological|FENDRIX|20 µg,Months 0, 1, 2 and 6
16346715|NCT00291928|Drug|Part A|Part A Cohort 1: HuMax-CD20 300 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 2: HuMax-CD20 700 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 3: HuMax-CD20 1000 mg at Days 0 and 14 or Placebo at Days 0 and 14
16346716|NCT00291928|Drug|Part B|Part B Group 1: HuMax-CD20 300 mg at Days 0 and 14 Group 2: HuMax-CD20 700 mg at Days 0 and 14 Group 3: HuMax-CD20 1000 mg at Days 0 and 14 Group 4: Placebo at Days 0 and 14
16346717|NCT00291915|Drug|Adalimumab|
16346718|NCT00291915|Drug|Methotrexate|
16346719|NCT00291902|Drug|SB-681323|
16346720|NCT00291889|Biological|Mtb72F/AS02.|
16346721|NCT00291876|Biological|Havrix™|2 doses at 12 months interval
16346722|NCT00291863|Drug|Simvastatin|
16346723|NCT00291850|Drug|Paclitaxel, Cisplatin, Pegfilgrastim|
16346724|NCT00291837|Drug|CT-2106|
16346725|NCT00291824|Behavioral|Cardiovascular risk factors and willingness to change|
16346726|NCT00291811|Drug|AMD3100 + G-CSF|Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session
16346727|NCT00291798|Procedure|rate of remission|
16346728|NCT00291785|Drug|CT-2106|CT-2106 as 10 minute infusion on days 1, 15 & 29 of each 42-day cycle
16346729|NCT00291785|Drug|Folinic acid|Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
16346730|NCT00291785|Drug|5-FU (fluorouracil)|5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.
16346731|NCT00291772|Drug|Pramlintide|Basal and bolus pramlintide subcutaneous infusion
16346732|NCT00291759|Drug|Tamoxifen|
16346733|NCT00291759|Drug|Anastrozole|
16346734|NCT00291746|Drug|Esomeprazole|
16346735|NCT00291746|Procedure|Bravo technique|
16346862|NCT00290680|Drug|celecoxib|
16346740|NCT00291707|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. The infusion rate of cetuximab must never exceed 5 mL/min.
16346741|NCT00291707|Drug|Pemetrexed|• Pemetrexed 350-500 mg/m2 IV over 10 minutes (see dose escalation design. Dose will be decreased to 200 mg/m2, if the first dose level of 350 mg/m2 is not tolerable) on days 1 and 22, (and 43 if >6000 cGy to be delivered)
16346742|NCT00291707|Procedure|radiation therapy|• Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1. Radiation will be given M-F for 6-7 consecutives weeks
16346743|NCT00291694|Drug|celecoxib|Celecoxib 400 mg BID
16346744|NCT00291694|Other|placebo|placebo
16346745|NCT00291668|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous use"
16346746|NCT00291668|Other|Placebo|"Active Substance: isotonic sodium chloride solution
~Pharmaceutical Form: Solution for injection
~Concentration: 1 mL
~Route of Administration: Subcutaneous use"
16346747|NCT00291655|Drug|Levetiracetam|500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
16346748|NCT00291642|Drug|Placebo drops|"Pharmaceutical form: Drops for oral administration
~Route of administration: Oral use"
16346749|NCT00291642|Drug|Placebo tablets matching to levocetirizine|"Pharmaceutical form: Tablets for oral administration
~Route of administration: Oral use"
16346750|NCT00291642|Drug|Placebo tablets matching to cetirizine|"Pharmaceutical form: Tablets for oral administration
~Route of administration: Oral use"
16346751|NCT00291642|Drug|Levocetirizine drops|"Pharmaceutical form: Drops for oral administration
~Concentration: 5 mg/ml
~Route of administration: Oral use"
16346752|NCT00291642|Drug|Levocetirizine tablets|"Pharmaceutical form: Tablets for oral administration
~Concentration: 5 mg
~Route of administration: Oral use"
16346753|NCT00291642|Drug|Cetirizine drops|"Pharmaceutical form: Drops for oral administration
~Concentration: 10 mg/ml
~Route of administration: Oral use"
16346754|NCT00291642|Drug|Cetirizine tablets|"Pharmaceutical form: Tablets for oral administration
~Concentration: 10 mg
~Route of administration: Oral use"
16346755|NCT00291629|Drug|G-CSF (Dong-A pharmaceutical, Seoul, Korea)|
16346756|NCT00291629|Procedure|collection of mobilized peripheral blood stem cells|
16346757|NCT00291629|Procedure|Intracoronary infusion of mobilized cells|
16346758|NCT00291616|Drug|Pegylated Interferon-alpha2a|180 microgram s.c. injection weekly
16346759|NCT00291616|Drug|Thymosin alpha1 & Pegylated Interferon-alpha2a|Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week
16346760|NCT00291603|Device|FX-class of dialyser|
16346761|NCT00291590|Behavioral|DHEP|
16346762|NCT00291577|Drug|Sunitinib (Sutent)|Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision
16346763|NCT00291577|Drug|Taxotere|Taxotere 75 mg/m2 iv, once every 3 weeks
16346764|NCT00291564|Device|Cardiac Resynchronization Therapy Device|
16346765|NCT00291551|Device|Placement of the PVSS Implant|Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
16346766|NCT00291538|Drug|bortezomib|
16346767|NCT00291525|Device|On-X valve using reduced anticoagulation|Valve replacement with antiplatelet agents or lowered warfarin
16346768|NCT00291525|Device|On-X Valve with Standard warfarin Therapy|Valve replacement with standard dosage warfarin
16346769|NCT00291512|Behavioral|Theory-based counseling program|
16346770|NCT00291499|Drug|Chondroitin 4&6 sulfate (Condrosulf)|800 mg/day for 6 months
16346771|NCT00291499|Other|Placebo|800 mg placebo/day for 6 months
16346772|NCT00291486|Drug|Capecitabine|Capecitabine will be administered at doses between 1000 and 1250 mg/m2/day depending on assigned dose level for 14 days per 21 day cycle. Daily doses may be rounded to the nearest 150mg.
16346773|NCT00291486|Drug|131I-huA33 (131-Iodine on humanised monoclonal antibody A33)|All patients will receive a scout dose of 5 mg huA33 conjugated to 5-8 mCi 131I. The therapy dose of 131I-huA33 will comprise a constant protein dose of 10 mg/m2 huA33 regardless of dose level. The 131I therapy dose will be determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
16346774|NCT00291473|Drug|CHP-HER2, CHP-NY-ESO-1|
16346775|NCT00291460|Device|inspiratory muscle training|
16346776|NCT00291447|Biological|ch806|ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
16346777|NCT00291408|Procedure|Skin Prick Test|
16346778|NCT00291408|Procedure|Impulse Oscillometry|
16346779|NCT00291408|Procedure|Exhaled Nitric Oxide|
16346780|NCT00291408|Procedure|Spirometry|
16346781|NCT00291408|Procedure|Reversibility|
16346782|NCT00291408|Procedure|Exhaled Breath Condensate|
16346783|NCT00291408|Procedure|Sputum Induction|
16346784|NCT00291395|Drug|PGI2|
16346785|NCT00291382|Drug|Salmeterol/fluticasone propionate combination|
16346786|NCT00291369|Drug|Interleukin-2|
16346787|NCT00291369|Drug|Interferon alfa|
16346788|NCT00291369|Drug|medroxyprogesterone acetate|
16346789|NCT00291356|Drug|GSK189075 oral tablets|
16346790|NCT00291356|Drug|GW869682 oral tablets|
16346791|NCT00291343|Biological|Tritanrix™- HepB|One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
16346792|NCT00291343|Biological|Hiberix™|One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
16346793|NCT00291343|Biological|Mencevax™ ACWY|One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
16346794|NCT00291330|Drug|dabigatran etexilate 150 mg|twice daily
16346795|NCT00291330|Drug|warfarin (INR 2-3)|prn to maintain INR (2-3)
16346863|NCT00290667|Biological|pegfilgrastim|
16346864|NCT00290667|Biological|rituximab|
16346865|NCT00290667|Drug|cyclophosphamide|
16346866|NCT00290667|Drug|doxorubicin hydrochloride|
16346867|NCT00290667|Drug|prednisone|
16346796|NCT00291317|Device|RT 300-P FES Cycle|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes per session over a 9 month period. The intervention was provided at Children's Specialized Hospital in Mountainside, and families were required to provide their own transportation. During the study, the participants continued to participate in their standard, primary rehabilitation program.
16346797|NCT00291304|Procedure|MRI|pre-surgery
16346798|NCT00291239|Behavioral|partial sleep deprivation|
16346799|NCT00291226|Drug|Glycine|Glycine 0.4 g/kg bid
16346800|NCT00291226|Drug|Placebo|Placebo
16346801|NCT00291213|Drug|levetiracetam|
16346802|NCT00291213|Drug|placebo|
16346803|NCT00291187|Drug|20 mg VEC-162|20 mg VEC-162
16346804|NCT00291187|Drug|50 mg VEC-162|50 mg VEC-162
16346805|NCT00291187|Drug|100 mg VEC-162|100 mg VEC-162
16346806|NCT00291187|Drug|Placebo|Placebo
16346807|NCT00291161|Behavioral|Partners in Dementia Care|"Partners in Dementia Care is facilitated by the VA Dementia care coordinator (VA DCC) that is with the study. The role of the VA DCC includes conducting initial assessments with the subject and caregiver that leads to:
~Arranging for further assessment or attention from VA health care system/providers about dementia related concerns or about co-morbid health issues; for example: VA driving evaluation, congestive heart failure medication adherence; Ensuring education is provided about particular health, safety issues; Following up with patient/caregiver on health promoting activities he/she is committed to do; and Sharing care plan actions/outcomes with other VA providers as agreed upon by patient."
16346808|NCT00291148|Drug|paroxetine|
16346809|NCT00291148|Drug|pregabalin|
16346810|NCT00291135|Drug|letrozole|Letrozole 2.5 mg daily
16346811|NCT00291122|Drug|celecoxib 400 mg BID|
16346812|NCT00291109|Drug|letrozole 2.5 mg|
16346813|NCT00291070|Drug|L-theanine|This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.
16346814|NCT00291057|Drug|MALG|30 minute application
16346815|NCT00291044|Other|testing for HSV 1 and 2 IgG type specific antibosy|
16346816|NCT00291031|Behavioral|Imagery Rehearsal Therapy (IRT)|"Imagery Rehearsal Therapy is given by psychologists, psychotherapists or psychiatrists. The IRT therapists are all trained by Annette van Schagen, principal investigator.
~IRT consists of six 1-hour sessions. The six sessions are given in a period of three months. Each session is described in the IRT Manual. The IRT Manual is devised by the principal investigator Annette van Schagen in colaboration with Victor Spoormaker PhD. There is a patient version of the IRT manual available for the patients, which includes descriptions of the IRT sessions and homework assignments."
16346817|NCT00291018|Device|Total Disc Replacement|Total Disc Replacement using ProDisc-C
16346818|NCT00291018|Device|ACDF|Anterior Cervical Discectomy and Fusion
16346819|NCT00291005|Drug|ARD6562, Docetaxel|
16346820|NCT00290992|Drug|rasburicase (SR29142)|
16346821|NCT00290979|Drug|insulin glulisine|
16346822|NCT00290966|Drug|XRP6976|
16346823|NCT00290953|Drug|SR48692|
16346824|NCT00290940|Drug|CS-917|
16346825|NCT00290940|Drug|metformin hydrochloride|
16346826|NCT00290940|Drug|pioglitazone|
16346827|NCT00290927|Drug|insulin glulisine|
16346828|NCT00290914|Drug|Vilazodone|
16346829|NCT00290901|Drug|Tramadol Hydrochloride 50mg|
16346830|NCT00290901|Drug|Celebrex 200mg|
16346831|NCT00290888|Procedure|Acromioplasty|
16346832|NCT00290875|Behavioral|Use of Xrays for diagnosis|
16346833|NCT00290862|Device|Percutaneous Vertebral Augmentation of compression fractures|Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
16346834|NCT00290849|Drug|Bivalirudin|
16346835|NCT00290836|Drug|Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)|
16346836|NCT00290823|Drug|Albendazole|400 mg tablet taken orally twice daily
16346837|NCT00290823|Drug|Dexamethasone|6mg or 8mg taken daily
16346838|NCT00290823|Drug|Omeprazole|20 mg tablet taken orally daily
16346839|NCT00290810|Biological|bevacizumab|Given IV
16346840|NCT00290771|Drug|Imatinib tablets|Imatinib was supplied as 100 and 400 mg tablets by Novartis.
16346841|NCT00290771|Drug|Hydroxyurea capsules|Hydroxyurea was supplied locally as 500 mg capsules.
16346842|NCT00290758|Drug|placebo|Given orally
16346843|NCT00290758|Drug|genistein|Given orally
16346844|NCT00290758|Other|laboratory biomarker analysis|Correlative studies
16346845|NCT00290745|Drug|letrozole|
16346846|NCT00290745|Drug|tamoxifen citrate|
16346847|NCT00290745|Procedure|conventional surgery|
16346848|NCT00290745|Procedure|neoadjuvant therapy|
16346849|NCT00290732|Drug|Intraductal arm|Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter
16346850|NCT00290732|Drug|Intravenous arm|Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.
16346851|NCT00290719|Drug|cisplatin|
16346852|NCT00290719|Drug|gefitinib|
16346853|NCT00290719|Drug|irinotecan hydrochloride|
16346854|NCT00290719|Procedure|conventional surgery|
16346855|NCT00290719|Procedure|neoadjuvant therapy|
16346856|NCT00290719|Radiation|radiation therapy|
16346857|NCT00290706|Drug|bortezomib|Bortezomib 1.6mg/m2 on days 1 and 15 of each cycle, given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
16346858|NCT00290706|Drug|gemcitabine hydrochloride|Gemcitabine dose of 800 mg/m2 over 30 minutes on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
16346859|NCT00290693|Drug|Capecitabine|Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
16346868|NCT00290667|Drug|vincristine sulfate|
16346869|NCT00290667|Other|pharmacological study|
16346870|NCT00290667|Radiation|radiation therapy|
16346871|NCT00290654|Drug|Tamoxifen|Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
16346872|NCT00290654|Procedure|Lumpectomy|A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
16346873|NCT00290654|Radiation|brachytherapy|Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.
16346874|NCT00290641|Biological|filgrastim|
16346875|NCT00290641|Biological|graft-versus-tumor induction therapy|
16346876|NCT00290641|Drug|cyclophosphamide|
16346877|NCT00290641|Drug|cyclosporine|
16346878|NCT00290641|Drug|fludarabine phosphate|
16346879|NCT00290641|Drug|mycophenolate mofetil|
16346880|NCT00290641|Procedure|umbilical cord blood transplantation|
16346881|NCT00290641|Radiation|radiation therapy|
16346882|NCT00290628|Drug|anti-thymocyte globulin|
16346883|NCT00290628|Drug|busulfan|
16346884|NCT00290628|Drug|cyclophosphamide|
16346885|NCT00290628|Drug|cyclosporine|
16346886|NCT00290628|Drug|filgrastim|
16346887|NCT00290628|Drug|melphalan|
16346888|NCT00290628|Drug|methylprednisolone|
16346889|NCT00290628|Drug|mycophenolate mofetil|
16346890|NCT00290628|Procedure|radiation therapy|
16346891|NCT00290628|Procedure|umbilical cord blood transplantation|
16346892|NCT00290615|Biological|bevacizumab|
16346893|NCT00290615|Biological|cetuximab|
16346894|NCT00290615|Drug|capecitabine|
16346895|NCT00290615|Drug|oxaliplatin|
16346896|NCT00290602|Drug|Methylprednisolone sodium succinate|
16346897|NCT00290589|Drug|Intramuscular methylprednisolone acetate|Intramuscular methylprednisolone acetate 160mg
16346898|NCT00290589|Drug|Placebo|Normal saline intramuscular injection
16346899|NCT00290576|Dietary Supplement|Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )|
16346900|NCT00290563|Drug|MK0594|
16346901|NCT00290550|Drug|MK0457|IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days
16346902|NCT00290537|Drug|ZD6474|ZD6474 alone: Cycles 1-3 = 300 mg PO Daily x 3 Weeks; ZD6474+Carboplatin+Paclitaxel = 300 mg oral (PO) Daily or 100 mg PO Daily plus Carboplatin and Paclitaxel Every 3 Weeks.
16346903|NCT00290537|Drug|Carboplatin|6 AUC IV Over 15-30 Minutes, Immediately After Paclitaxel
16346904|NCT00290537|Drug|Paclitaxel|200 mg/m^2 IV Over 3 Hours On Day 1
16346905|NCT00290524|Behavioral|Oral alimentation started 12 hours after colorectal surgery|
16346906|NCT00290511|Drug|Fludarabine|25 mg/m^2 intravenous (IV) over 5-30 minutes on Days 2-4.
16346907|NCT00290511|Drug|Mitoxantrone|10 mg/m^2 IV over 5-30 minutes on Day 2.
16346908|NCT00290511|Drug|Rituximab|375 mg/m^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total).
16346909|NCT00290511|Drug|Zevalin|0.3 mCi/kg IV after 4 cycles of R-FND.
16346910|NCT00290511|Drug|Dexamethasone|20 mg by mouth (PO) or IV daily on Days 2-6.
16346911|NCT00290498|Drug|Rituximab|Arm A: Rituximab 375 mg/m² by vein on day 1, Cycle 1 and alternating cycles. Arm B: Rituximab 375 mg/m² on day 1, Cycle 2 and alternating cycles.
16346912|NCT00290498|Drug|Cyclophosphamide|"Arm A: Cyclophosphamide 300 mg/m^2 by vein (IVPB) over 3 hours every 12 hours x 6 doses on Days 2-4, Cycle 1 and alternating cycles.
~Arm B: Cyclophosphamide 750 mg/m² by vein day 1"
16346913|NCT00290498|Drug|Doxorubicin|Arm A: Doxorubicin 50 mg/m^2/day by vein over 15 minutes (12 hours after last dose of cyclophosphamide) on Day 5, Cycle 1 and alternating cycles.
16346914|NCT00290498|Drug|Vincristine|"Arm A: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12, Cycle 1 and alternating cycles.
~Arm B: Vincristine 1.4 mg/m^2 (maximum 2 mg) by vein (IVPB) on Days 5 (1-24 hours after last cyclophosphamide) and on day 12 of each cycle."
16346915|NCT00290498|Drug|Dexamethasone|Arm A: Dexamethasone 40 mg by vein or by mouth daily x 4 on Days 2-5 and on days 12-15 of cycle 1 and alternating cycles.
16346916|NCT00290498|Drug|Methotrexate|Arm A: Methotrexate after finishing Rituximab, 200 mg/m2 by vein over 2 hours, then 800 mg/m2 by vein over 22 hours day 1 cycle 2.
16346917|NCT00290498|Drug|Cytarabine|Arm B: Cytarabine 3 g/m^2 by vein over 2 hours every 12 hours X 4 doses on days 3 & 4, cycle 2 and alternating cycles.
16346918|NCT00290498|Drug|Prednisone|Arm B: Prednisone 100 mg by mouth (as a pill, capsule, or tablet) once a day on Days 1-5, each cycle.
16346919|NCT00290485|Drug|Imatinib mesylate|
16346920|NCT00290472|Drug|temsirolimus|
16346921|NCT00290433|Drug|Cyclophosphamide|Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.
16346922|NCT00290433|Drug|Mesna|Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.
16346923|NCT00290433|Drug|Vincristine|Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.
16346924|NCT00290433|Drug|Methotrexate|Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.
16346925|NCT00290433|Drug|Ara-C|Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.
16346926|NCT00290433|Drug|Dexamethasone|Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.
16346927|NCT00290433|Drug|G-CSF|Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.
16346928|NCT00290433|Drug|Doxil|Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.
16346929|NCT00290420|Drug|Chloroquine profilaxis|"Prevention:
~Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes"
16346930|NCT00290407|Drug|Rituximab|375 mg/m2, IV (in the vein), once a week for 4 weeks
16346931|NCT00290407|Dietary Supplement|Beta-Glucan|250 mg, orally (tablet), three times a day for 9 weeks
16346932|NCT00290394|Drug|rosiglitazone(drug), blood pressure lowering effect|
16346933|NCT00290381|Drug|Study drug administration|
16346934|NCT00290381|Procedure|Skin prick test|
16346935|NCT00290381|Procedure|12-lead ECG|
16346936|NCT00290381|Procedure|Laboratory safety samples|
16346937|NCT00290381|Procedure|Alcohol breath test|
16346938|NCT00290381|Procedure|Smokerlyzer test|
16346939|NCT00290381|Procedure|Urine drug test|
16346940|NCT00290381|Procedure|Blood test for drug concentrations|
16346941|NCT00290381|Procedure|Nasal allergen challenge|
16346942|NCT00290381|Procedure|Nasal filter paper placement|
16346943|NCT00290381|Procedure|Total nasal symptoms scores|
16346944|NCT00290368|Procedure|Skin Prick Test|
16346945|NCT00290368|Procedure|Nasal allergen challenge|
16346946|NCT00290368|Procedure|Nasal filter paper placement|
16346947|NCT00290368|Procedure|Nasal lavage|
16346948|NCT00290368|Procedure|Nasal scrape|
16346949|NCT00290368|Procedure|Nasal symptoms score|
16346950|NCT00290355|Biological|GSK 249553 vaccine|Intramuscular injection, 13 doses
16346951|NCT00290355|Biological|Placebo|Intramuscular administration, 13 doses
16346952|NCT00290342|Biological|DTPa-IPV|3 intramuscular injections
16346953|NCT00290342|Biological|DTPa|3 intramuscular injections
16346954|NCT00290342|Biological|IMOVAX Polio®|3 intramuscular injections
16346955|NCT00290329|Biological|Mencevax ACWY|1 subcutaneous injection.
16346956|NCT00290316|Procedure|Endoscopy ultrasound|
16346957|NCT00290303|Biological|DTPw-HBV/Hib-MenAC conjugate vaccine|
16346958|NCT00290290|Drug|chlorhexidine-alcohol|Preoperative skin preparation with scrub and paint technique
16346959|NCT00290290|Drug|Povidone-Iodine|preoperative skin preparation with scrub and paint technique
16346960|NCT00290277|Biological|HPV-16/18 L1/AS04|
16346961|NCT00290264|Drug|Budesonide/formoterol|
16346962|NCT00290251|Drug|ulipristal acetate|ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic
16346963|NCT00290251|Drug|ulipristal acetate|10 mg given daily for three menstrual cycles or 90 - 102 days
16346964|NCT00290251|Drug|placebo|placebo given once daily for 3 menstrual cycles or 90 - 102 days
16346965|NCT00290238|Device|Vertis Percutaneous Neuromodulation Therapy (PNT)|"Ten PNT sessions in eleven weeks
~On average, one PNT session per week
~Ten lumbar Safeguide electrodes (three centimeters in length) deployed per lumbar montage
~Forty-five minutes of electrical stimulation for each session
~Electrical stimulation parameters:
~Continuous 50 Hz current
~Charge-balanced, biphasic (each phase is 200 microsec), rectangular waveform
~Intensity to subject's tolerance for ten minutes then increased to a mildly uncomfortable level"
16346966|NCT00290238|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|"Ten TENS sessions in eleven weeks
~On average, one TENS session per week
~Four 2-inch (5.1 centimeters) diameter pads applied per TENS lumbar montage
~Forty-five minutes of electrical stimulation for each session
~Electrical stimulation parameters:
~Current at 2 Hz-low frequency
~Pulse trains delivered as asymmetric, biphasic, square waveform current, with pulse width lasting 20 microsec
~Intensity titrated according to subject's sensory threshold
~To maintain blinding, the treating physician or clinician will check on the subject after 10 minutes and dial the channels down just prior to the point of turning off the device."
16346967|NCT00290225|Behavioral|Breath Water Sound Course and Traumatic Incident Reduction|
16346968|NCT00290212|Drug|Natto capsules (food suppl.) cont. 360 microg. vit K2/day|
16346969|NCT00290212|Drug|Placebo capsules|
16346970|NCT00290199|Device|Transcervical Foley catheter|Foley catheter placed through cervix for cervical ripening
16346971|NCT00290186|Device|Hyperbaric Oxygen Treatment|100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
16346972|NCT00290186|Device|Hyperbaric Air Treatment|14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
16346973|NCT00290173|Drug|efficacy of oral ritodrine in maintaining uterine quiescence|
16346974|NCT00290160|Behavioral|Protein supplementation|
16346975|NCT00290147|Biological|D1ME100 (dengue-1 premembrane/envelope DNA vaccine)|IM injection delivered by Biojector
16346976|NCT00290134|Drug|Fispemifene once daily for 4 weeks|
16346977|NCT00290121|Drug|Olanzapine|
16346978|NCT00290108|Drug|Propofol|
16346979|NCT00290082|Drug|loxapine, midazolam|agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
16346980|NCT00290082|Biological|blood sample|was evaluated in patients sedated, alcohol level, blood sugar
16346981|NCT00290082|Other|patient monitoring|Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
16346982|NCT00290082|Drug|Loxapine|Loxapine 1 mL / 10 kg
16346983|NCT00290082|Drug|Midazolam|Midazolam 1 mL / 10 Kg
16346984|NCT00290069|Drug|Tacrolimus|
16346985|NCT00290069|Drug|Rapamycin|
16346986|NCT00290056|Drug|Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).|3.6 gram oral supplementation for 6 months.
16346987|NCT00290043|Drug|Insulin glulisine|
16346988|NCT00290030|Drug|Alfuzosin|
16346989|NCT00290017|Drug|talabostat|
16346990|NCT00290017|Drug|pemetrexed|
16346991|NCT00290004|Drug|motexafin gadolinium|
16346992|NCT00289991|Drug|Itraconazole|Prophylaxis
16346993|NCT00289991|Drug|Vfend - voriconazole|Prophylaxis
16346994|NCT00289978|Drug|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
16346995|NCT00289978|Drug|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
16346996|NCT00289978|Drug|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
16346997|NCT00289965|Behavioral|Counselor-administered Brief Motivational Intervention (BMI)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
16346998|NCT00289965|Behavioral|Alcohol 101 Plus (interactive CD-ROM)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
16346999|NCT00289965|Behavioral|AlcoholEdu (Internet-based tutorial)|Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
16347000|NCT00289952|Drug|Valproic Acid|Oral valproic acid twice daily for 16 or 32 weeks. Dosage varies based on plasma levels.
16347001|NCT00289952|Drug|HAART|As per standard of care.
16347002|NCT00289939|Behavioral|Motivational interviewing to reduce risk for HIV and DV|
16347003|NCT00289926|Drug|dehydroepiandrosterone|dehydroepiandrosterone capsules 50.0 mg /capsule DHEA 248.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule
16347004|NCT00289926|Drug|placebo|Placebo capsules of 298.5 mg /capsule Microcrystalline Cellulose, NF 1.5 mg /capsule Magnesium Stearate, NF in a 60 mg Capsule manufactured to mimic the active DHEA capsule
16347005|NCT00289913|Biological|Comparator: VAQTA™|"VAQTA™ (Hepatitis A Vaccine, Inactivated).
~Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age."
16347006|NCT00289913|Biological|Comparator: Infanrix™|"Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis
~Vaccine Adsorbed, GlaxoSmithKline).
~One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit."
16347007|NCT00289913|Biological|Comparator: PedvaxHIB™|"PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).
~One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit."
16347008|NCT00289900|Drug|MK-0524A|
16347009|NCT00289900|Drug|Atorvastatin|
16347010|NCT00289900|Drug|Simvastatin|
16347011|NCT00289887|Drug|Comparator: losartan +/- HCTZ|Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.
16347012|NCT00289887|Drug|Comparator: Placebo|Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
16347013|NCT00289874|Drug|montelukast sodium|montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
16347014|NCT00289874|Drug|Comparator: Placebo|Placebo. Up to 3 weeks of treatment
16347015|NCT00289861|Drug|Risperidone|
16347016|NCT00289861|Drug|placebo|
16347017|NCT00289848|Drug|sitagliptin phosphate|Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
16347018|NCT00289848|Drug|Comparator: placebo|placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
16347019|NCT00289835|Device|Paclitaxel eluting stent|Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
16347020|NCT00289822|Drug|intracoronary infusion of progenitor cells|
16347021|NCT00289809|Drug|combination of TLC D-99 and Ifosfamide|"TLC D-99: 40 mg/m2 Day 1 every 3 weeks;
~Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks"
16347022|NCT00289796|Biological|DTPa-HBV-IPV/Hib|GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine
16347023|NCT00289783|Biological|GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine|3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
16347024|NCT00289783|Biological|ActHIB|3-dose intramuscular injection at 2, 4 and 6 months of age.
16347025|NCT00289783|Biological|PedvaxHIB|1 booster dose by intramuscular injection at 12 to 15 months of age.
16347026|NCT00289783|Biological|Pediarix|3-dose intramuscular injection at 2, 4 and 6 months of age.
16347027|NCT00289783|Biological|Prevnar|3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
16347028|NCT00289783|Biological|M-M-R II|1 booster dose by subcutaneous injection at 12 to 15 months of age.
16347029|NCT00289783|Biological|Varivax|1 booster dose by subcutaneous injection at 12 to 15 months of age
16347030|NCT00289770|Biological|Twinrix™|Intramuscular injection, 3 doses
16347031|NCT00289757|Biological|Havrix™|2 doses at 6 months interval
16347032|NCT00289744|Biological|TWINRIX™ ADULT|2 doses IM injection in primary study
16347033|NCT00289744|Biological|Engerix TM|If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
16347034|NCT00289731|Biological|TWINRIX™|Intramuscular injection, 3 doses
16347035|NCT00289731|Biological|Engerix™-B|Intramuscular injection, 3 doses
16347036|NCT00289731|Biological|HAVRIX™|Intramuscular injection, 2 doses
16347037|NCT00289731|Biological|HB VAX PRO™|Intramuscular injection, 3 doses
16347038|NCT00289731|Biological|Vaqta™|Intramuscular injection, 2 doses
16347039|NCT00289718|Biological|Twinrix™ adult|Intramuscular administration
16347040|NCT00289705|Procedure|Surgery|Laparoscopic Roux-en-Y gastric bypass
16347041|NCT00289679|Device|Hip prosthesis revision|
16347042|NCT00289653|Drug|Nicoderm|
16347043|NCT00289640|Drug|ipilimumab (MDX-010, BMS-734016)|IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
16347044|NCT00289640|Drug|Ipilimumab|IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
16347045|NCT00289640|Drug|Ipilimumab|IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
16347046|NCT00289627|Drug|ipilimumab (MDX-010, BMS-734016)|IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
16347047|NCT00289614|Drug|Iopamidol 370 mgI/dL|
16347051|NCT00289562|Drug|forodesine hydrochloride (BCX-1777)|
16347052|NCT00289549|Drug|forodesine hydrochloride (BCX-1777)|experimental, forodesine oral dose 200 mg administered daily.
16347053|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|15 IU/kg rAHF-PFM
16347054|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|30 IU/kg rAHF-PFM
16347055|NCT00289536|Biological|Antihemophilic factor, recombinant, manufactured protein-free|50 IU/kg rAHF-PFM
16347056|NCT00289510|Biological|Inactivated influenza vaccine (whole virion, Vero cell-derived)|
16347057|NCT00289510|Biological|Inactivated influenza vaccine (egg derived) [licensed control vaccine]|
16347058|NCT00289497|Device|TempTouch®|
16347059|NCT00289484|Drug|Omega-3 Polyunsaturated Fatty Acids|
16347060|NCT00289471|Other|No intervention delivered.|No intervention delivered.
16347061|NCT00289458|Behavioral|exercise|A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
16347062|NCT00289458|Behavioral|2|Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.
16347063|NCT00289458|Behavioral|Control|no exercise
16347064|NCT00289445|Drug|Mitomycin C|
16347065|NCT00289445|Drug|5-FU|
16347066|NCT00289445|Drug|Folinic acid|
16347067|NCT00289432|Behavioral|Psychoeducative|The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment
16347068|NCT00289432|Other|Support group|Standard Hospital follow-up support group
16347069|NCT00289419|Drug|Epidural Ropivacaine, morphine|Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml
16347070|NCT00289419|Drug|Ropivacaine, Ketorolac and Adrenaline|Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml
16347071|NCT00289406|Drug|S-amlodipine gentisate|
16347072|NCT00289406|Drug|Amlodipine besylate|
16347073|NCT00289393|Behavioral|Perceived outcome by both patient and physician|
16347074|NCT00289367|Drug|Triiodothyronine|0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
16347075|NCT00289367|Drug|triiodothyronine|IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
16347076|NCT00289354|Drug|Chromium Picolinate (600 mcg Cr) + biotin (2 mg)|
16347077|NCT00289341|Biological|vaccine vehicle only|Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.
16347078|NCT00289341|Biological|DC/LNCaP|Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH
16347079|NCT00289315|Behavioral|Primary (Environmental) Weight Gain Prevention|School-based program that modifies the school environment to promote healthy eating and physical activity
16347080|NCT00289315|Behavioral|Secondary (Behavioral) Weight Gain Prevention|School-based environmental program to promote healthy eating and physical activity in the overweight students.
16347081|NCT00289315|Behavioral|Control|Control program that does not include an active intervention for promoting healthy eating and physical activity.
16347082|NCT00289302|Device|Cardiac resynchronization therapy device|
16347083|NCT00289289|Device|Intervention Pacing Features|Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
16347084|NCT00289276|Device|Fluid Status Monitoring (OptiVol™)|Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
16347085|NCT00289263|Drug|Paclitaxel|
16347086|NCT00289250|Drug|Sulfadoxine-pyrimethamine|
16347087|NCT00289250|Drug|Sulfadoxine-pyrimethamine plus artesunate|
16347088|NCT00289237|Behavioral|Lifestyle intervention|
16347089|NCT00289224|Biological|bivalent killed whole cell oral cholera vaccine|"Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains:
~V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS"
16347090|NCT00289224|Biological|Placebo|Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.
16347091|NCT00289211|Biological|C1 esterase inhibitor [human] (C1INH-nf)|
16347092|NCT00289211|Drug|Placebo (saline)|
16347093|NCT00289198|Drug|FF|fluticasone furoate 110 μg nasal spray
16347094|NCT00289198|Drug|Placebo|placebo nasal spray
16347095|NCT00289185|Biological|RTS,S/AS02D|3-dose intramuscular injection in the thigh
16347096|NCT00289185|Biological|Engerix-B®|3-dose intramuscular injection in the thigh.
16347097|NCT00289185|Biological|TETRActHib™|3-dose intramuscular injection in the thigh.
16347098|NCT00289172|Biological|Live attenuated human rotavirus vaccine|
16347099|NCT00289133|Device|total knee arthroplasty|Gamma Vacuum Foil polyethylene tibial insert
16347100|NCT00289133|Device|total knee arthroplasty|cross-linked polyethylene tibial insert
16347101|NCT00289120|Drug|Cola beverage|Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.
16347102|NCT00289120|Drug|Deionized water|Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm
16347103|NCT00289107|Device|Total Knee Arthroplasty|Rotating Platform (RP) Cruciate Substituting Knee System
16347104|NCT00289107|Device|Total knee replacement|Fixed Cruciate Substituting Knee System
16347105|NCT00289094|Device|Total Knee Replacement|Rotating Platform (RP) Cruciate Retaining Knee System
16347106|NCT00289094|Device|Total knee replacement|Fixed Cruciate Retaining Knee System
16347107|NCT00289081|Device|Total Knee Replacement|Rotating Platform (RP) Cruciate Retaining Knee implant
16347108|NCT00289081|Device|Total knee replacement|Rotating Platform (RP) Cruciate Substituting Knee implant.
16347109|NCT00289068|Procedure|Phacoemulsification Sleeve surgery|Group 2.2 mm surgery setting
16347110|NCT00289068|Procedure|Phacoemulsification Sleeves surgery|Group 2.8 mm surgery setting
16347111|NCT00289068|Procedure|Phacoemulsification Sleeves|Group 3.0 mm surgery setting
16347112|NCT00289055|Device|stent|Cordis SMART™ Nitinol Stent
16347113|NCT00289055|Device|angioplasty|balloon angioplasty
16347114|NCT00289042|Drug|Enoxaparin|
16347115|NCT00289029|Drug|Iopamidol 370 mgI/mL|
16347116|NCT00289016|Drug|Talimogene Laherparepvec|Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
16347117|NCT00289003|Drug|Soluble beta-1,3/1,6-glucan|
16347118|NCT00288977|Procedure|Islet Infusion|
16347119|NCT00288964|Device|Hattler Respiratory Assist Catheter|
16347120|NCT00288951|Drug|Travoprost 0.004% with and without BAK|
16347121|NCT00288925|Drug|Z-360|
16347122|NCT00288912|Behavioral|Health Education|12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
16347123|NCT00288912|Behavioral|Osteoarthritis Self-Management|12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
16347124|NCT00288899|Other|"Enhanced surgical iMedConsent process (with repeat back)"|"Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to repeat backwhat they understand."
16347125|NCT00288899|Other|standard surgical iMedConsent process|Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.
16347126|NCT00288886|Behavioral|Contracting, Prompting and Reinforcement arm|Contracting, prompting and reinforcement of continuing care and abstinence.
16347127|NCT00288886|Behavioral|Control arm|Routine residential treatment and orientation to continuing care.
16347128|NCT00288873|Drug|Ergocalciferol|
16347129|NCT00288873|Drug|Cholecalciferol|
16347130|NCT00288860|Behavioral|Telephone monitoring|Three months of biweekly telephone monitoring and support
16347131|NCT00288860|Other|Treatment-As-Usual|Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
16347132|NCT00288834|Behavioral|dysphagia rehabilitation|
16347133|NCT00288808|Device|Hemosense (PT/InR point of care device)|
16347134|NCT00288795|Other|Massage Therapy|Therapeutic Touch
16347135|NCT00288795|Other|Polarity Therapy|Use of energy fields to alleviate distress and achieve balance in the body
16347136|NCT00288782|Drug|Mirtazapine|
16347137|NCT00288769|Drug|daily sublingual tablets Vitamin B12 1000 mcg versus placebo|
16347138|NCT00288756|Procedure|lv injection of contrast|
16347139|NCT00288743|Drug|to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.|
16347140|NCT00288730|Drug|nesiritide|
16347141|NCT00288717|Drug|Candesartan|
16347142|NCT00288717|Drug|Telmisartan|
16347143|NCT00288704|Drug|rilonacept 160 mg|Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. On Day 1, subjects received two injections of rilonacept (for a total of 320 mg).
16347144|NCT00288704|Drug|Placebo|Subcutaneous injection of Placebo occurred during first 6 weeks of the study or during randomized withdrawal (weeks 15-24). On Day 1, subjects received two placebo injections.
16347145|NCT00288704|Drug|rilonacept 160 mg|Rilonacept was given by subcutaneous injection. It was administered weekly at the dose of 160mg. No loading dose was given for subjects who entered directly into the open-label.
16347146|NCT00288691|Drug|Asoprisnil (BAY86-5294)|5mg/day
16347147|NCT00288691|Drug|Asoprisnil (BAY86-5294)|10mg/day
16347148|NCT00288691|Drug|Asoprisnil (BAY86-5294)|25mg/day
16347149|NCT00288691|Drug|Placebo|Placebo
16347150|NCT00288678|Procedure|Health Education|
16347151|NCT00288665|Device|Export catheter (Medtronic)|
16347152|NCT00288652|Drug|[S,S]-Reboxetine|
16347153|NCT00288639|Drug|Pregabalin|"Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).
~Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID)."
16347154|NCT00288626|Drug|Granulocyte-colony stimulating factor (G-CSF) and prednisone|Growth factor regimen; occurs at study entry
16347155|NCT00288626|Drug|Carmustine, etoposide, cytarabine, and melphalan (BEAM)|High-dose chemotherapy; occurs seven or more days following collection of autologous graft
16347156|NCT00288626|Procedure|Autologous hematopoietic stem cell transplant|Occurs after growth factor regimen and collection of autologous graft
16347157|NCT00288600|Drug|Intravenous Immunoglobulin|Intravenous Immunoglobulin
16347158|NCT00288600|Drug|Normal saline solution|Normal saline solution 10 ml/Kg
16347159|NCT00288587|Drug|IV loop diuretic|Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
16347160|NCT00288587|Device|NxStage System One|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
16347161|NCT00288574|Drug|Fluoxetine|
16347162|NCT00288574|Drug|Placebo|
16347163|NCT00288561|Drug|ranibizumab|
16347164|NCT00288548|Drug|Metoprolol|
16347165|NCT00288535|Procedure|PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique|
16347166|NCT00288522|Drug|Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days|
16347270|NCT00287885|Drug|docetaxel|Three patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day
16347271|NCT00287872|Drug|bortezomib|
16347167|NCT00288509|Biological|Botulinum toxin type A|In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
16347168|NCT00288496|Drug|polyethylene glycol bowel lavage solution|
16347169|NCT00288483|Drug|Policosanol|
16347170|NCT00288470|Device|Hylaform, Hylaform Plus (hylan B gel)|
16347171|NCT00288457|Device|Ureteral Stent|Ureteral stents are not investigatory but rather part of standard of care. In this study, we were interested in having patients fill out pre and post-operative questionnaires so that we could compare their symptoms with the length of their ureter and the stent placed.
16347172|NCT00288444|Drug|Lonafarnib|
16347173|NCT00288444|Drug|Docetaxel|
16347174|NCT00288431|Drug|ridaforolimus|Different schedules and routes of administration of AP23573 will be examined. For each schedule, AP23573 + Doxorubicin will be co-administered on Day 1 of a 3-week cycle. AP23573 will be given orally and will range in dose from 10-30 mg per dose.
16347175|NCT00288431|Drug|Doxorubicin|administered at 60 mg/m2 intravenously every 3 weeks
16347176|NCT00288418|Device|Central Venous Catheter|7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
16347177|NCT00288405|Device|Cordis Self Expanding Stent|
16347178|NCT00288392|Drug|Soluble beta-1,3/1,6-glucan|
16347179|NCT00288379|Drug|formoterol|
16347180|NCT00288379|Drug|budesonide/formoterol|
16347181|NCT00288366|Drug|ziprasidone vs. aripiprazole|ziprasidone vs. aripiprazole dosed according to package insert
16347182|NCT00288366|Drug|aripiprazole vs. ziprasidone|aripiprazole vs. ziprasidone dosed according to package insert
16347183|NCT00288353|Drug|aripiprazole (Abilify)|active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.
16347184|NCT00288353|Drug|ziprasidone (Geodon)|active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
16347185|NCT00288340|Device|functional magnetic resonance imaging|
16347186|NCT00288327|Behavioral|Lifestyle behavior change program|Intervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls.
16347187|NCT00288327|Behavioral|Pamphlets|Nutritional and physical activity pamphlets from American Heart Association
16347188|NCT00288314|Procedure|Magnetic Resonance Imaging, Functional|Structural and functional MRI
16347189|NCT00288301|Behavioral|Weight loss intervention|weight loss intervention
16347190|NCT00288288|Procedure|Epicardial left ventricular lead placement|Epicardial left ventricular lead placement
16347191|NCT00288288|Procedure|Transvenous left ventricular lead implant|Transvenous left ventricular lead implant
16347192|NCT00288262|Drug|melatonin 0.5 mg|
16347193|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
16347194|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
16347195|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
16347196|NCT00288249|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
16347197|NCT00288236|Drug|Rimonabant (SR141716)|
16347198|NCT00288236|Drug|Placebo|
16347199|NCT00288223|Drug|Telithromycin|one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.
16347200|NCT00288210|Procedure|Primary angioplasty in acute myocardial infarction|
16347201|NCT00288197|Drug|voriconazole|
16347202|NCT00288184|Drug|Allopurinol|Allopurinol adminsitered one 200mg capsule by mouth twice daily. Placebo capsule once daily during crossover
16347203|NCT00288184|Drug|Placebo|
16347204|NCT00288171|Drug|Placebo|placebo capsule twice daily for one month
16347205|NCT00288171|Drug|Allopurinol|Allopurinol 200mg twice daily for one month
16347206|NCT00288158|Drug|Allopurinol|
16347207|NCT00288158|Drug|Probenecid|
16347208|NCT00288158|Drug|Placebo|
16347209|NCT00288145|Behavioral|WOW, Working On Wellness weight management|Treatment site, worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management.
16347210|NCT00288132|Behavioral|Intervention|A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
16347211|NCT00288132|Behavioral|Usual Care|Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
16347272|NCT00287872|Drug|thalidomide|
16347273|NCT00287859|Drug|topotecan hydrochloride|intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
16347274|NCT00287846|Drug|imatinib mesylate|
16347275|NCT00287833|Other|placebo|Given orally
16347276|NCT00287833|Drug|Bowman-Birk inhibitor concentrate|Given orally
16347277|NCT00287820|Drug|Olanzapine|olanzapine 5-40 mg/day
16347278|NCT00287820|Drug|olanzapine|olanzapine 5-40 ,mg/day
16347279|NCT00287820|Drug|risperidone|risperidone 1-12 mg/day
16347212|NCT00288119|Device|Balloon Capsule Device|The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
16347213|NCT00288119|Procedure|Endoscopy|An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
16347214|NCT00288106|Other|Follow-up|No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
16347215|NCT00288093|Radiation|3-Dimensional Conformal Radiation Therapy|
16347216|NCT00288093|Drug|Triapine|
16347217|NCT00288080|Drug|Dexamethasone|Premedication of dexamethasone prior to docetaxel, per institutional standards.
16347218|NCT00288080|Drug|Prednisone|10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
16347219|NCT00288080|Drug|docetaxel|75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
16347220|NCT00288080|Drug|Oral antiandrogen|Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
16347221|NCT00288080|Radiation|Radiation therapy|46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
16347222|NCT00288080|Drug|LHRH agonist|LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
16347223|NCT00288067|Drug|fenretinide|Given PO
16347224|NCT00288067|Drug|rituximab|Given IV
16347225|NCT00288054|Biological|cetuximab|"Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only.
~250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles."
16347226|NCT00288054|Drug|docetaxel|"Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2.
~20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2."
16347227|NCT00288054|Radiation|radiation therapy|"Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review.
~RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications."
16347228|NCT00288041|Drug|carboplatin|Given IV
16347229|NCT00288041|Drug|paclitaxel|Given IV
16347230|NCT00288041|Drug|bortezomib|Given IV
16347231|NCT00288028|Drug|bortezomib|Dose of Bortezomib* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days
16347232|NCT00288015|Biological|Bevacizumab|Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).
16347233|NCT00288002|Biological|trastuzumab|
16347234|NCT00288002|Drug|capecitabine|
16347235|NCT00288002|Drug|cyclophosphamide|
16347236|NCT00288002|Drug|docetaxel|
16347237|NCT00288002|Drug|epirubicin hydrochloride|
16347238|NCT00288002|Procedure|adjuvant therapy|
16347239|NCT00288002|Procedure|conventional surgery|
16347240|NCT00288002|Procedure|neoadjuvant therapy|
16347241|NCT00287989|Drug|Carboplatin|
16347242|NCT00287989|Drug|erlotinib hydrochloride|150mg
16347243|NCT00287989|Drug|Paclitaxel|200mg/m2
16347244|NCT00287989|Drug|erlotinib hydrochloride|1500mg
16347245|NCT00287976|Drug|irinotecan hydrochloride|
16347246|NCT00287963|Drug|topotecan hydrochloride|
16347247|NCT00287963|Drug|vinorelbine tartrate|
16347248|NCT00287950|Drug|carboplatin|
16347249|NCT00287950|Drug|cisplatin|
16347250|NCT00287950|Drug|cyclophosphamide|
16347251|NCT00287950|Drug|etoposide|
16347252|NCT00287950|Drug|vincristine sulfate|
16347253|NCT00287950|Procedure|adjuvant therapy|
16347254|NCT00287950|Procedure|conventional surgery|
16347255|NCT00287950|Procedure|neoadjuvant therapy|
16347256|NCT00287950|Radiation|radiation therapy|
16347257|NCT00287937|Drug|vorinostat|Given orally
16347258|NCT00287937|Drug|paclitaxel|Given IV
16347259|NCT00287937|Drug|carboplatin|Given IV
16347260|NCT00287937|Other|laboratory biomarker analysis|Correlative studies
16347261|NCT00287937|Other|pharmacological study|Correlative studies
16347262|NCT00287924|Drug|methotrexate|
16347263|NCT00287924|Procedure|adjuvant therapy|
16347264|NCT00287911|Drug|cisplatin|intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
16347265|NCT00287911|Drug|topotecan hydrochloride|intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
16347266|NCT00287911|Radiation|brachytherapy|Some patients may also undergo brachytherapy
16347267|NCT00287911|Radiation|radiation therapy|once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36
16347268|NCT00287898|Behavioral|Telephone Genetic Counseling|Participants will receive all genetic counseling via telephone
16347269|NCT00287898|Behavioral|Usual Care|subjects will receive standard in-person genetic counseling
16347280|NCT00287807|Behavioral|Self-monitoring of blood glucose (SMBG)|2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial
16347281|NCT00287794|Drug|diazepam, melatonin|Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.
16347282|NCT00287781|Drug|Lidocaine|
16347283|NCT00287768|Drug|docetaxel + S-1|Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
16347284|NCT00287768|Drug|S-1|S-1 po days 1-28 every 6 weeks
16347285|NCT00287755|Drug|S-1|S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
16347286|NCT00287742|Drug|risperidone|
16347287|NCT00287729|Drug|Pirfenidone|2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.
16347288|NCT00287729|Drug|Placebo|Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
16347289|NCT00287716|Drug|Pirfenidone|1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.
16347290|NCT00287716|Drug|Placebo|Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
16347291|NCT00287703|Device|Pulsating Electro-Magnetic Fields|5 days a week for 5 weeks 30 minutes
16347292|NCT00287703|Device|Pulsating Electro-Magnetic Fields sham|sham PEMF
16347293|NCT00287690|Drug|Genistein|Drink taken once daily
16347294|NCT00287690|Drug|Placebo|Drink taken once daily
16347295|NCT00287677|Biological|recombinant human Growth Hormone|Growth Hormone during 6 months (30UG/KG/DAY)
16347296|NCT00287677|Biological|Vaccination|Vaccination (Hepatitis A+B + tetanus toxoid) at week 16
16347297|NCT00287677|Drug|HAART|HAART all over the trial
16347298|NCT00287664|Drug|terlipressin|
16347299|NCT00287651|Procedure|Pulsatile IV Insulin|Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.
16347300|NCT00287651|Procedure|Effects of Pulsatile IV Insulin on Diabetic Retinopathy|Control Patients are not given pulsatile intravenous insulin therapy during the study.
16347301|NCT00287651|Procedure|Effects of Pulsatile IV Insulin on Diabetic Retinopathy|Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.
16347302|NCT00287638|Device|CPAP|Continuous positive pressure device with a time clock
16347303|NCT00287638|Device|placebo|no CPAP
16347304|NCT00287625|Procedure|Pulmonary rehabilitation|Pulmonary rehabilitation
16347305|NCT00287612|Procedure|Lap. Fundo. with Mobilization of the Esophageal Junction|Complete mobilization of the esophageal junction
16347306|NCT00287612|Procedure|Lap. Fundo. without Mobilization of the Esophageal Junction|phrenoesophageal membrane left intact
16347307|NCT00287586|Drug|Testosterone Gel (Androgel)|7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years
16347308|NCT00287586|Drug|Placebo|Placebo-matching testosterone gel daily for 3 years
16347309|NCT00287573|Device|TAXUS Express2|Paclitaxel-Eluting Coronary Stent System
16347310|NCT00287573|Procedure|Brachytherapy (beta source)|Brachytherapy (beta source)
16347311|NCT00287560|Drug|propofol (drug)|
16347312|NCT00287547|Drug|CTLA4Ig / Abatacept|
16347313|NCT00287534|Drug|Anastrozole|oral
16347314|NCT00287534|Drug|Tamoxifen|oral
16347315|NCT00287521|Drug|AL-37807 Ophthalmic Suspension, 1.0%|One drop in the study eye(s) once daily for 28 days
16347316|NCT00287521|Drug|Latanoprost, 0.005% (Xalatan)|One drop in the study eye(s) once daily for 28 days
16347317|NCT00287521|Other|AL-37807 Vehicle|One drop in the study eye(s) once daily for 28 days
16347318|NCT00287521|Drug|Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%|One drop in the study eye(s) once daily for 28 days
16347319|NCT00287508|Device|Carotid artery stenting with filter (interventional)|
16347320|NCT00287495|Drug|BAY 43-9006|BAY 43-9006 200 mg once daily with dose escalation up to 400 mg twice daily
16347321|NCT00287482|Drug|Essiac|
16347322|NCT00287469|Biological|Hepatitis E vaccine, recombinant (Sar 56 kDa)|20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
16347323|NCT00287469|Other|Placebo|PBS buffer placebo containing alum
16347324|NCT00287456|Device|Insulin Pump|
16347325|NCT00287456|Drug|Insulin|0
16347326|NCT00287456|Procedure|Oral Glucose Tolerance Test|0
16347327|NCT00287456|Procedure|Whole body Protein Turnover|0
16347328|NCT00287443|Procedure|Oral Glucose tolerance test|
16347329|NCT00287443|Procedure|Whole body protein turnover|
16347330|NCT00287443|Procedure|IV glucose tolerance test|
16347331|NCT00287443|Procedure|Indirect Calorimetry|
16347332|NCT00287443|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
16347333|NCT00287443|Procedure|Growth Hormone Stimulation Test|
16347334|NCT00287430|Drug|Growth Hormone|
16347335|NCT00287430|Procedure|Whole body Protein Turnover Study|
16347336|NCT00287430|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
16347337|NCT00287417|Device|echography|
16347338|NCT00287417|Other|blood sample|
16347339|NCT00287391|Drug|Rabeprazole|
16347340|NCT00287378|Drug|omalizumab|omalizumab as per weight and IgE
16347341|NCT00287365|Drug|ozone|2 hour exposure to 0.4 ppm ozone
16347342|NCT00287352|Drug|Olanzapine, Amantadine|Olanzapine continuing as clinically indicated, Amantadine 100 mg tid
16347343|NCT00287352|Drug|Olanzapine and placebo|Olanzapine continuing as clinically indicated
16347344|NCT00287339|Drug|Esomeprazole|40mg capsule BID for 12 weeks
16347345|NCT00287339|Drug|Placebo|placebo capsule BID for 12 weeks
16347346|NCT00287326|Drug|Bupivacaine, Clonidine, Morphine|
16347347|NCT00287313|Drug|Vitamin K|
16347348|NCT00287300|Drug|Sulfadoxine-Pyrimethamine|
16347349|NCT00287300|Drug|Azithromycin|
16347350|NCT00287300|Drug|Artesunate|
16347460|NCT00286247|Genetic|INGN 201|
16347351|NCT00287287|Drug|Lenalidomide|Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
16347352|NCT00287274|Device|computerized physician order entry|
16347353|NCT00287261|Drug|zoledronic acid|4 mg IV every 3 weeks for 36 weeks
16347354|NCT00287248|Drug|[123I] IMPY & SPECT Imaging|Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging
16347355|NCT00287235|Device|MARS|
16347356|NCT00287235|Drug|Standard Medical Therapy|
16347357|NCT00287222|Drug|Bevacizumab|15 mg/KG I.V. every 21 days
16347358|NCT00287222|Drug|Erlotinib|150 mg orally every day
16347359|NCT00287209|Drug|Amiodarone|
16347360|NCT00287196|Radiation|Radiotherapy|48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
16347361|NCT00287183|Drug|PF-04494700 (TTP488)|60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
16347362|NCT00287183|Other|Placebo|Placebo
16347363|NCT00287170|Drug|Delayed Release 6MP or Calcitriol vs. Purinethol|
16347364|NCT00287157|Drug|Sublingual Tizanidine HCl|
16347365|NCT00287131|Procedure|Procedure - Adoptive cell transfer|Procedure - Adoptive cell transfer
16347366|NCT00287118|Drug|Efalizumab|Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
16347367|NCT00287105|Drug|Standard chemotherapy + Imatinib|Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase
16347368|NCT00287092|Biological|DT5aP-IPV-Hib 5-component Pertussis vaccine|0.5 mL, IM
16347369|NCT00287092|Biological|Infanrix® -IPV+Hib|0.5 mL, IM
16347370|NCT00287079|Drug|Rebif®|44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
16347371|NCT00287079|Other|No Treatment|No treatment for 96 weeks
16347372|NCT00287066|Drug|Inhaled Human Insulin|
16347373|NCT00287066|Drug|Regular Human Insulin|
16347374|NCT00287053|Drug|divalproex sodium|Divalproex sodium vs. placebo
16347375|NCT00287040|Behavioral|Tailored, interactive intervention for mammography screening|Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings
16347376|NCT00287027|Drug|Risperdal Long Acting Injectable Antipsychotic Medication|
16347377|NCT00287001|Device|Cold air cooling|
16347378|NCT00286988|Drug|Topiramate|
16347379|NCT00286975|Behavioral|Leadership development program educational intervention|
16347380|NCT00286962|Device|MIP 2007C implantable insulin pump|Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
16347381|NCT00286962|Device|continuous subcutaneous insulin infusion (CSII) or MDI|
16347382|NCT00286949|Drug|Atomoxetine|Open Label uncontrolled active Drug intervention
16347383|NCT00286936|Drug|Zolpidem|
16347384|NCT00286923|Drug|Topiramate|
16347385|NCT00286897|Drug|E2007|
16347386|NCT00286884|Procedure|Monitoring of heart rate variability|
16347387|NCT00286871|Drug|Neoral|
16347388|NCT00286871|Drug|Tacrolimus|
16347389|NCT00286858|Device|Insignia Ultra and Insignia AVT|Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
16347390|NCT00286845|Drug|Standard Chemotherapy|physician determined
16347391|NCT00286832|Procedure|PET scan|One extra PET scan after 1 cycle of treatment.
16347392|NCT00286819|Drug|the FEC75 and 95 regimen|"Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
~Arm B: the FEC90 regimen will be given at the following doses:
~Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
~All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
~Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
~Six cycles of adjuvant chemotherapy will be administered in both arms (A + B"
16347393|NCT00286806|Drug|AT-101|
16347394|NCT00286793|Drug|AT-101|Oral
16347395|NCT00286780|Drug|AT-101|80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks
16347396|NCT00286754|Behavioral|SMI|Stage-matched intervention
16347397|NCT00286754|Behavioral|HEI|Health Education Intervention
16347398|NCT00286754|Behavioral|UC|Usual Care
16347399|NCT00286754|Behavioral|SMI|Stage-matched intervention
16347400|NCT00286754|Behavioral|HEI|Health Education Intervention
16347401|NCT00286754|Behavioral|UC|Usual Care
16347402|NCT00286741|Other|Diabetes Group Management Visits|Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
16347403|NCT00286728|Behavioral|Intensive referral to dual-focused self-help|4 group sessions to introduce patients to dual focused groups
16347404|NCT00286702|Device|hand splint|
16347405|NCT00286689|Drug|Growth Hormone|
16347406|NCT00286689|Procedure|Whole body Protein turnover|
16347407|NCT00286689|Procedure|DEXA scan|
16347408|NCT00286676|Drug|Nutropin|
16347409|NCT00286676|Procedure|Oral Glucose Tolerance Test|
16347410|NCT00286676|Procedure|Dual Energy X-ray Absorptiometry (DEXA)|
16347411|NCT00286676|Procedure|Computed Tomography (CT) Scan|
16347412|NCT00286650|Procedure|3rd molar teeth extraction|
16347413|NCT00286624|Biological|Allogeneic Islets of Langerhans|Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight.
16347414|NCT00286624|Drug|Everolimus|Loading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter.
16347415|NCT00286624|Drug|anti-thymocyte globulin|A total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2.
16347416|NCT00286624|Drug|Cyclosporine|Cyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter.
16347417|NCT00286611|Procedure|Blood and salivary sampling of amifostine|Sampling of blood and saliva to test for amifostine levels.
16347418|NCT00286598|Behavioral|Feet First|Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.
16347419|NCT00286585|Drug|Inhalational anesthetic|Sevoflurane, dosage according to the physician in charge
16347420|NCT00286585|Drug|Intravenous anesthetic, propofol|Propofol, dosage according to the physician in charge
16347421|NCT00286559|Drug|SonoVue|
16347422|NCT00286559|Drug|Optison|
16347423|NCT00286533|Procedure|Clinical examination (implant stability, gingiva condition, etc.)|Clinical examination (implant stability, gingiva condition, etc.) to follow
16347424|NCT00286533|Procedure|Questionnaires|Questionnaires are used.
16347425|NCT00286520|Procedure|Transanal irrigation with Peristeen Anal Irrigation|
16347426|NCT00286507|Procedure|Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.|Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling
16347427|NCT00286494|Drug|Alogliptin and pioglitazone|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
16347428|NCT00286494|Drug|Alogliptin and pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
16347429|NCT00286494|Drug|Pioglitazone|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
16347430|NCT00286481|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
16347431|NCT00286481|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
16347432|NCT00286481|Drug|Simvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
16347433|NCT00286468|Drug|Alogliptin and glyburide|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
16347434|NCT00286468|Drug|Alogliptin and glyburide|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
16347435|NCT00286468|Drug|Glyburide|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
16347436|NCT00286455|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
16347437|NCT00286455|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
16347438|NCT00286455|Drug|Placebo|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
16347439|NCT00286442|Drug|Alogliptin and metformin|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
16347440|NCT00286442|Drug|Alogliptin and metformin|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
16347441|NCT00286442|Drug|Metformin|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
16347442|NCT00286429|Drug|Alogliptin and insulin|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
16347443|NCT00286429|Drug|Alogliptin and insulin|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
16347444|NCT00286429|Drug|Insulin|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
16347445|NCT00286416|Drug|omalizumab (Xolair)|
16347446|NCT00286403|Drug|Fenoldopam Mesylate and/or MESNA|
16347447|NCT00286390|Procedure|Acupuncture|
16347448|NCT00286377|Drug|prosaptide|
16347449|NCT00286364|Drug|Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH|
16347450|NCT00286351|Drug|Combined treatment with Arimidex and Zoladex before IVF|
16347451|NCT00286325|Drug|Rituximab|Infusion of 1000 mg of rituximab on day 0 and day 14
16347452|NCT00286312|Drug|Atorvastatin|
16347453|NCT00286299|Other|Aerobic high-intensity interval training (AIT)|The AIT group trains 4x4 minute interval training on a treadmill at 85-95 % HRpeak interspersed with 3 minutes of active resting periods at a work load corresponding to 70% HRpeak between each interval. All training sessions are monitored and start with a 6 minute warm-up and end with a 5 minute cool-down period at a work load corresponding to 70% HRpeak. Intervals are performed walking or running on a treadmill with a minimum of 5% inclination, 3 times per week for 8 weeks.
16347454|NCT00286299|Other|Computer game training (CG)|The CG spend the same amount of time (36 minutes), training to improve their ability in the computer game, Tetris. Tetris is a game where small shapes called Tetraminoes fall from the top of the Playfield to the bottom. Players must rotate the Tetraminoes as they fall and fit them together to complete lines. When the player fills an entire line with blocks, that line is removed from the screen. If the player cannot complete lines, the blocks will eventually rise past the top of the screen, and the game ends.
16347455|NCT00286299|Other|Maximal strength training|Training starts with a 10 minute warm-up on the treadmill. Maximal strength training is then performed in an inclined leg press machine. The subject lifts 4 maximal repetitions that are repeated 4 times after a 2 minute rest period. Subjects are instructed to lift the weight with an intention of maximal mobilization of force. Training load is increased each time the subject manage to perform 4x4 maximal repetitions. Training is carried out 3 times per week in 8 weeks.
16347456|NCT00286286|Device|Intraperitoneal Aerosolization System, IntraMyst|
16347457|NCT00286273|Drug|trisodium citrate|for regional anticoagulation of the extracorporeal CVVH circuit
16347458|NCT00286273|Drug|nadroparin|for anticoagulation of the extracorporeal CVVH circuit
16347459|NCT00286260|Drug|levetiracetam|Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks
16347466|NCT00286221|Drug|PCA fentanyl|"PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted"
16347467|NCT00286221|Drug|PRN fentanyl|IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
16347468|NCT00286208|Drug|Mifepristone, misoprostol|
16347469|NCT00286195|Device|Multi-Link Frontier Coronary Stent System|Bare metal stent
16347470|NCT00286182|Drug|Erythropoietin alpha|Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in any given weekly interval.
16347471|NCT00286182|Drug|Placebo|Placebo
16347472|NCT00286169|Drug|Amrubicin Hydrochloride|
16347473|NCT00286156|Drug|Rapamune|Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml Group 3- Standard Care
16347474|NCT00286143|Drug|Fentanyl|Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.
16347475|NCT00286130|Drug|Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan|
16347476|NCT00286130|Drug|FOLFOX 6|"FOLFOX 6:
~Oxaliplatin 100 mg/m² d1 concurrent with
~Leucovorin 400 mg/m², followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:"
16347477|NCT00286130|Drug|FOLFIRI|"FOLFIRI:
~Irinotecan 180 mg/m² day 1 concurrent with
~Leucovorin 400 mg/m² followed by
~Bolus 5FU 400 mg/m², followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks"
16347478|NCT00286117|Drug|Anastrozole|oral
16347479|NCT00286117|Drug|Tamoxifen|oral
16347480|NCT00286104|Device|Antibiotics-impregnated ventricular catheter (Bactiseal®)|Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
16347481|NCT00286104|Device|Plain ventricular catheter (Codman EDS II/III)|Plain ventricular catheter
16347482|NCT00286091|Biological|Denosumab|Administered by subcutaneous injection
16347483|NCT00286091|Biological|Placebo|Same volume subcutaneous injection
16347484|NCT00286078|Device|Precision|Implantable neurostimulator
16347485|NCT00286065|Drug|AeroLEF|
16347486|NCT00286052|Drug|Low Dose Naloxone|
16347487|NCT00286039|Procedure|Blood sampling|Blood sampling is used.
16347488|NCT00286026|Drug|Azithromycin|1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg. One dose vs 2 doses given 30 days apart.
16347489|NCT00286013|Drug|Association of gemcitabine, oxaliplatin and radiotherapy|
16347490|NCT00286000|Drug|Administration of high dose simplified folfiri|
16347491|NCT00285987|Procedure|Reconstruction of the cruciate ligament|
16347492|NCT00285974|Device|metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis|metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
16347493|NCT00285961|Device|Cork splint materials (instead of plaster splint)|
16347494|NCT00285948|Device|Primary Birmingham hip resurfacing arthroplasty using a metal-on-metal couple|
16347495|NCT00285935|Other|Standard Clinical Care with an SRRI|"Participants who enroll in this phase are treated with an FDA-approved SSRI in an open-label treatment-as-usual manner, in accordance with clinical practices and at a titration rate no more rapid than the manufacturer's recommendations. The duration of the treatment phase is 8 weeks.
~Other Name: fluoxetine (Prozac®), Sertraline (Zoloft®), paroxetine (Paxil®), citalopram (Celexa®), escitalopram (Lexapro®)"
16347496|NCT00285909|Behavioral|Alcohol: 25 gday (white wine)|
16347497|NCT00285896|Drug|Glucagon-like-peptide-1 (7-36) amide|Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours
16347498|NCT00285896|Drug|Placebo|continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours
16347499|NCT00285883|Drug|Invirase|
16347500|NCT00285883|Drug|Norvir|
16347501|NCT00285857|Drug|Lovastatin|"Lovastatin 80 mg/day as 40 mg orally twice daily.
~Lovastatin is approved by FDA as a cholesterol-lowering agent."
16347502|NCT00285844|Behavioral|weight loss|
16347503|NCT00285844|Drug|thiazolidinedione|
16347504|NCT00285818|Drug|Mifepristone|Mifepristone is a glucocorticoid receptor antagonist.
16347505|NCT00285818|Drug|Placebo Oral Capsule|Placebo is a capsule without a pharmacological active ingredient
16347506|NCT00285805|Drug|Rosiglitazone versus placebo|
16347507|NCT00285805|Drug|response (sodium excretion) to amiloride infusion|
16347508|NCT00285805|Drug|response (sodium excretion) to furosemide infusion|
16347509|NCT00285792|Behavioral|Physical Activity|
16347510|NCT00285779|Drug|Etanercept|etanercept 50 mg twice weekly for 12 weeks
16347511|NCT00285779|Drug|Placebo|
16347512|NCT00285766|Drug|Selegiline Transdermal System|
16347513|NCT00285753|Behavioral|support groups|cognitive behavioral intervention with psychoeducation
16347514|NCT00285740|Behavioral|Cognitive Behavioral Therapy (CBT) in a Group Format|
16347515|NCT00285727|Drug|Ropinirole CR|
16347516|NCT00285714|Procedure|3D stereophotogrammetric imaging|
16347517|NCT00285714|Procedure|3D CT-imaging with cone-beam CT|
16347518|NCT00285714|Procedure|Case report form|
16347519|NCT00285701|Drug|hexaminolevulinate|
16347701|NCT00283946|Drug|Zolpidem MR|Oral
16347520|NCT00285688|Procedure|gastroscopic examination|gastroscopic examination for tissue biopsy and real time PCR for gene study
16347521|NCT00285675|Drug|DN-101 (calcitriol) - Drug|
16347522|NCT00285662|Drug|Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo|Children will get 25mg/1.25mg/kg of SP as a single dose, 4 mg/kg for 3 days of Artesunate and 10 mg/kg for 3 days of Amodiaquine in their respective arms
16347523|NCT00285649|Other|HVLA-SM|HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
16347524|NCT00285649|Other|LVVA-SM|LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
16347525|NCT00285649|Other|Usual Medical Care|Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
16347526|NCT00285623|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|treatment in surgery for improvement of haemostasis where standard techniques are insufficient
16347527|NCT00285597|Drug|Ursodeoxycholic Acid|
16347528|NCT00285584|Drug|Bupropion|Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
16347529|NCT00285584|Drug|Placebo|Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
16347530|NCT00285571|Behavioral|Controlled Feeding Intervention|
16347531|NCT00285558|Behavioral|CBT with peer-enhanced activities|
16347532|NCT00285558|Behavioral|CBT with supervised aerobic exercise|
16347533|NCT00285519|Drug|Doxazosin (drug)|
16347534|NCT00285493|Drug|Antibiotics|
16347535|NCT00285467|Drug|doxercalciferol|form of vitamin D that is already in active form.
16347536|NCT00285467|Drug|Cholecalciferol|from of vitamin D that requires cells in the body to make active
16347537|NCT00285454|Procedure|Retrograde coronary venous delivery of cells.|
16347538|NCT00285428|Drug|hA20-humanized anti-CD20 antibody|once weekly iv dosing for 4 weeks
16347539|NCT00285415|Drug|Docetaxel and Carboplatin|docetaxel (75 mg/m2) + carboplatin (AUC 6) IV every 3 weeks X 6 cycles
16347540|NCT00285402|Drug|AST-726 Low dose|
16347541|NCT00285402|Drug|AST-726 High dose|
16347542|NCT00285402|Drug|AST-726 Placebo|
16347543|NCT00285389|Drug|Adriblastin|
16347544|NCT00285389|Drug|dexamethasone|
16347545|NCT00285389|Drug|Chlorambucil|
16347546|NCT00285389|Drug|rituximab|
16347547|NCT00285389|Drug|cyclophosphamide|
16347548|NCT00285389|Drug|alkeran|
16347549|NCT00285389|Procedure|Total body irradiation (8Gy/4fr)|
16347550|NCT00285389|Drug|vincristine|0,4 mg/day day 1 to day 4
16347551|NCT00285376|Drug|vilazodone|titration to 40mg tablets qd for 8 weeks
16347552|NCT00285350|Drug|mycophenolate mofetil|
16347553|NCT00285337|Procedure|Laminectomy and Laminoplasty|Posterior versus anterior approach to laminectomy and laminoplasty
16347554|NCT00285298|Drug|Pentoxifylline|
16347555|NCT00285298|Drug|Placebo|
16347556|NCT00285285|Device|Point of Care Device; i-Stat Analyzer|
16347557|NCT00285259|Biological|VCL-CB01|5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
16347558|NCT00285259|Other|Phosphate-buffered Saline (PBS)|1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
16347559|NCT00285233|Biological|Allogeneic islets of Langerhans transplant|Allogeneic islets of Langerhans transplant
16347560|NCT00285220|Procedure|Laparoscopic Truncal Vagotomy|
16347561|NCT00285207|Drug|placebo|5 days of 28 day cycle for 2 cycles
16347562|NCT00285207|Drug|A007|5 days of 28 day cycle
16347563|NCT00285194|Drug|Allogeneic Islets of Langerhans|
16347564|NCT00285194|Drug|hOKT3γ1 (Ala-Ala)|
16347565|NCT00285181|Drug|Simvastatin|
16347566|NCT00285168|Behavioral|Bone Density Decision Aide|Absolute 10-year Fracture Risk Report
16347567|NCT00285155|Drug|Bupropion|
16347568|NCT00285142|Drug|rosiglitazone|
16347569|NCT00285129|Device|ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing|
16347570|NCT00285116|Procedure|Clinical examination and radiological evaluation|
16347571|NCT00285103|Drug|SPC2996|
16347572|NCT00285090|Dietary Supplement|Calcium, Vitamin D|
16347573|NCT00285090|Dietary Supplement|Calcium,Vitamin D|
16347574|NCT00285090|Dietary Supplement|Calcium, VitaminD|
16347575|NCT00285090|Other|Sugar Pill|
16347576|NCT00285077|Drug|SR57667B|
16347577|NCT00285064|Procedure|CT|
16347578|NCT00285051|Drug|inhaled delta-8-THC 300mcg or 600mcg per dose|"drugs to be used to prevent/treat nausea and/or vomiting due to cancer chemotherapy drug Patients will receive chemotherapy on day 0 and receive study medication, return on day 1or 2 and again on day 4 to return medication. There will be at least 10 days between the last dose of study medication from the first cycle and the first dose for the 2nd cycle..
~Patients will receive for each chemotherapy cycle either IV Ondansetron and Placebo inhalation, or IV Placebo and delta-8-THC inhalation. The patients will be randomized to receive one of 2 doses of the THC, either 300mcg or THC or 600mcg of THC"
16347579|NCT00285025|Drug|SR57667B|
16347580|NCT00285012|Drug|placebo|1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
16347581|NCT00285012|Drug|Varenicline Tartarate|1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
16347582|NCT00284999|Drug|Soothe|
16347583|NCT00284999|Drug|Refresh Tears|
16347584|NCT00284986|Drug|Prochymal (TM)|Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
16347585|NCT00284973|Biological|Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720|
16347586|NCT00284947|Drug|basiliximab|40 mg once every 28 days intravenously for 24 weeks
16347587|NCT00284947|Drug|MMF/EC-MPS|1g MMF or 720mg EC-MPS p.o twice daily
16347588|NCT00284947|Drug|Corticosteroids|Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
16347589|NCT00284934|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|
16347590|NCT00284934|Drug|Tacrolimus|
16347591|NCT00284934|Drug|Corticosteroids|At a dose of at least 5 mg/day.
16347592|NCT00284921|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16347593|NCT00284908|Drug|S-Tenatoprazole-Na (STU-Na)|30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning
16347594|NCT00284869|Drug|LPS|
16347595|NCT00284856|Drug|montelukast sodium|montelukast 10 mg tablet once daily, 6 month treatment period
16347596|NCT00284856|Drug|Comparator: Placebo|fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
16347597|NCT00284856|Drug|Comparator: fluticasone|fluticasone propionate 250 mcg twice daily, 6 month treatment period
16347598|NCT00284856|Drug|Comparator: Placebo|montelukast 10 mg Pbo tablet once daily, 6 month treatment period
16347599|NCT00284830|Device|Implantable Pulse Generators|dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
16347600|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 1 mg/kg for 51 weeks.
16347601|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
16347602|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; 6 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
16347603|NCT00284817|Drug|MEDI-522|Administered as a 30-minute IV infusion; on Study Day 0 followed by weekly maintenance doses of 3mg/kg for 51 weeks.
16347604|NCT00284817|Drug|MEDI-522|The next cohort of patients will be treated after at least 3 of 4 patients treated in the previous cohort receive at least 3 weeks of treatment and experience no dose-limiting toxicity (DLT).
16347605|NCT00284804|Drug|MDX-060|anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
16347606|NCT00284791|Drug|Lamotrigine (drug)|
16347607|NCT00284791|Drug|Fluoxetine (drug)|
16347608|NCT00284791|Drug|sertraline (drug)|
16347609|NCT00284778|Drug|Alimta®|
16347610|NCT00284778|Drug|Taxotere®|
16347611|NCT00284765|Procedure|flector|
16347612|NCT00284752|Drug|Abraxane|This is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA
16347613|NCT00284739|Drug|Alteplase|2mg or 4mg given twice daily for three days into loculated abscess
16347614|NCT00284739|Other|saline|saline injection twice daily for three days
16347615|NCT00284726|Device|Celsior Cold Storage Solution|
16347616|NCT00284713|Procedure|intracoronary infusion of BMC|catheter delivery of stem cells
16347617|NCT00284700|Drug|Iron|
16347618|NCT00284687|Drug|Artesunate|PO Artesunate
16347619|NCT00284674|Device|Hip prosthesis (re-cap, m2a-magnum and C2a-taper)|
16347620|NCT00284661|Procedure|FAST FIX|Fast fix repair of a meniscal tear
16347621|NCT00284661|Procedure|Meniscal suturing|standard suturing of meniscal tear
16347622|NCT00284648|Procedure|Surgical repair Achilles tendon rupture|
16347623|NCT00284648|Procedure|Non-surgical repair Achilles tendon rupture|
16347624|NCT00284635|Procedure|Fast track vs conventional|
16347625|NCT00284622|Procedure|Arthroscopy|HTO with pre-scope
16347626|NCT00284609|Behavioral|Group based non-pharmacological rehabilitation|"6 x 1.5 hours education program in group classes taught by nurse, physiotherapist, dietitian and chiropodist.
~24 x 1.5 hours training program (both aerobic and anaerobic exercise) in group classes supervised by a physiotherapist.
~3 x 3 hours cooking sessions in group classes supervised by a dietitian.
~Intervention period: 6 month"
16347627|NCT00284609|Behavioral|Individual non-pharmacological rehabilitation|"Individual counseling in Outpatient Clinic, including patient education, physical activity and diet instruction.
~4 x 1 hour with a diabetes nurse,
~3 x 0.5 hour with a dietitian and
~1 hour with a chiropodist.
~Intervention period: 6 month"
16347628|NCT00284596|Procedure|High tibial osteotomy|HTO
16347629|NCT00284583|Drug|Injection of Steroid into Foot|
16347630|NCT00284583|Drug|Injection of Alcohol into Foot|
16347631|NCT00284583|Drug|Injection of Lidocaine into Foot|
16347632|NCT00284557|Behavioral|Group-based behavioral intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
16347633|NCT00284531|Drug|Daclizumab|
16347634|NCT00284518|Biological|botulinum toxin Type A|Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
16347635|NCT00284518|Drug|normal saline|Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
16347636|NCT00284505|Drug|thalidomide|
16347637|NCT00284492|Procedure|Traditional chinese medicine type acupuncture|10 acupuncture sessions
16347638|NCT00284492|Behavioral|Self Care|Lifestyle advice on diet, physical activity
16347639|NCT00284479|Behavioral|Walking 45 mins 2x p.w.|
16347640|NCT00284466|Procedure|MS-CT Coronary Angiography|MS-CT Coronary Angiography done
16347702|NCT00283946|Drug|Zolpidem|Oral
16347703|NCT00283933|Drug|migalastat HCl|
16347641|NCT00284453|Procedure|Peripheral blood sampling|blood samples will be collected within 72 hours of subjects receiving >2, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks).
16347642|NCT00284427|Drug|vitamin C|IV Vitamin C given 2-3 times a week
16347643|NCT00284414|Procedure|Ultrasonography or MRI|
16347644|NCT00284401|Procedure|Evaluation of the placement of the Delta prosthesis|
16347645|NCT00284388|Procedure|Simultaneous controlled power measurement|
16347646|NCT00284388|Procedure|Surface EMG measurement|
16347647|NCT00284375|Procedure|Registration of all big toe prostheses in Ghent University Hospital|Registration of all big toe prostheses in Ghent University Hospital.
16347648|NCT00284362|Procedure|Arthroscopic or open surgery for hallux rigidus|
16347649|NCT00284349|Device|Use of a rehabilitation brace instead of a plaster|
16347650|NCT00284336|Drug|Caelyx|
16347651|NCT00284336|Drug|endoxan|
16347652|NCT00284323|Drug|Adenosine|
16347653|NCT00284310|Procedure|Anamnesis and clinical examination|Anamnesis and clinical examination to follow.
16347654|NCT00284297|Procedure|History taken and clinical examination|History is taken and clinical examination is followed
16347655|NCT00284284|Device|Use of a rehabilitation brace|
16347656|NCT00284271|Drug|Cyclophosphamide|
16347657|NCT00284271|Drug|Adramycin|
16347658|NCT00284271|Drug|Procarbacine|
16347659|NCT00284271|Drug|Prednisone|
16347660|NCT00284271|Drug|Vincristine|
16347661|NCT00284271|Drug|Bleomycin|
16347662|NCT00284271|Drug|Erythropoietin beta|
16347663|NCT00284258|Drug|CPT-11 and TS-1|TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.
16347664|NCT00284258|Drug|CPT-11, 5-FU and l-LV|Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.
16347665|NCT00284232|Behavioral|Use and interpretation of blood glucose results|
16347666|NCT00284232|Drug|Insulin dosing based on SMBG chart and education|
16347667|NCT00284219|Device|Transcranial Magnetic Stimulation 10Hz|3. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.
16347668|NCT00284219|Device|Magnetic stimulation using a special sham coil|Sham stimulation will be given at the same location as the active, with special sham coil.
16347669|NCT00284206|Drug|long-acting injectable risperidone|
16347670|NCT00284193|Drug|rFVIIa-FEIBA therapy for hemophilia A inhibitors|DOses tailored per ex vivo spiking thrombin generation
16347671|NCT00284193|Drug|FEIBA- Activated Prothrombin Complexes|
16347672|NCT00284180|Drug|Vinflunine|Novel second generation vinca alkaloid
16347673|NCT00284180|Drug|Trastuzumab|Anti-HER2 monoclonal antibody
16347674|NCT00284167|Behavioral|tailored web-based weight management intervention|
16347675|NCT00284154|Drug|Vinflunine|320mg/m2 every 21 days as a 15-20 minute infusion
16347676|NCT00284141|Drug|Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)|"Aflibercept 4.0 mg/kg administered intravenously (IV) over a period of at least 1 hour once every 2 weeks.
~Aflibercept could be reduced by 1 dose level (to 3.0 mg/kg) or 2 dose levels (to 2.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
16347677|NCT00284128|Drug|AVE7688|oral administration (capsules)
16347678|NCT00284128|Drug|Losartan-potassium|oral administration (capsules)
16347679|NCT00284115|Device|Gait trainer|Mechanical gait repetitive training
16347680|NCT00284115|Device|Conventional rehabilitation|Physiotherapeutic conventional rehabilitation
16347681|NCT00284102|Procedure|Mechanical ventilation|measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)
16347682|NCT00284089|Drug|Ranibizumab|Ranibizumab was administered by intravitreal injection in the study eye. Intravitreal injection was performed by the investigator following slitlamp examination.
16347683|NCT00284076|Drug|L-arginine|
16347684|NCT00284063|Procedure|Low back adjustment and MRI|Subjects received a 15 minutes MRI in neutral position, a chiropractic low back spinal manipulation, and a second 15 minute MRI in neutral position.
16347685|NCT00284063|Procedure|Low back adjustment and MRI|Subjects received a 15 minutes MRI in neutral position, a chiropractic spinal manipulation to the low back, and a second 15 minute MRI in a side posture position.
16347686|NCT00284063|Procedure|MRI|Subjects received a 15 minute MRI in neutral position and a second 15 minute MRI in neutral position.
16347687|NCT00284050|Drug|Ranibizumab 0.3 mg|6 mg/ml ranibizumab solution for intravitreal injection
16347688|NCT00284050|Drug|Ranibizumab 0.5 mg|10 mg/ml ranibizumab solution for intravitreal injection
16347689|NCT00284050|Drug|Sham injection|Non-treatment control for sham intravitreal injection.
16347690|NCT00284037|Device|continuous positive airway pressure therapy|
16347691|NCT00284024|Drug|domperidone|
16347692|NCT00284011|Dietary Supplement|SAMe|800 mg dose daily for 4 weeks.
16347693|NCT00284011|Other|Placebo|2 placebo pills daily for 4 weeks.
16347694|NCT00283998|Procedure|surgical versus conservative treatment|Surgical treatment of fractures versus conservative stabilization
16347695|NCT00283985|Drug|Kidrolase|6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
16347696|NCT00283985|Drug|Methotrexate|3 gr/m2 at J1
16347697|NCT00283985|Drug|Dexamethasone|40 mg/ per os at J1, J2 and J4.
16347698|NCT00283985|Drug|Erwinase|"In case of allergy to Kidrolase
~20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles"
16347699|NCT00283972|Device|LAP-BAND System|
16347700|NCT00283959|Drug|migalastat HCl|
16347705|NCT00283855|Behavioral|Online Self-Management|Online Self-Management
16347706|NCT00283842|Drug|DVS SR|
16347707|NCT00283842|Drug|Placebo|
16347708|NCT00283829|Drug|docetaxel|chemotherapy
16347709|NCT00283829|Drug|IL2|immunotherapy
16347710|NCT00283816|Drug|Metformin|Metformin 500 mg. tabs 2 tabs BID for duration of study
16347711|NCT00283816|Drug|Oral Contraceptive Pill|"Yasmin, drospirenone and ethinyl estradiol 28 tablets
~1 tab daily for duration of study"
16347712|NCT00283816|Behavioral|Lifestyle Management Program|Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise & behavior modification skills on a regular weekly basis over the 24 week study
16347713|NCT00283816|Behavioral|Quality of Life Questionnaire|Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion
16347714|NCT00283816|Procedure|Oral Glucose Tolerance Test|"Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance.
~Performed twice during study, at baseline and conclusion"
16347715|NCT00283816|Procedure|Blood work|Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.
16347716|NCT00283816|Procedure|Abdominal Ultra Sound|"transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume.
~Performed twice during study, at baseline and conclusion"
16347717|NCT00283816|Procedure|Dual-energy x-ray absorptiometry (DEXA scan)|Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion
16347718|NCT00283816|Drug|placebo|placebo capsules, two capsules BID
16347719|NCT00283803|Drug|Exisulind|Oral antineoplastic agent that induces apoptosis in cancerous cells.
16347720|NCT00283803|Drug|luteinizing hormone-releasing hormone (LHRH) agonist|Hormonal therapy to suppress testosterone as a standard treatment for Prostate Cancer.
16347721|NCT00283803|Drug|Antiandrogen|Hormonal therapy used as lead in treatment with luteinizing hormone-releasing hormone (LHRH) agonist to prevent the initial rise in testosterone (testosterone flare) seen during the first dose of LHRH agonists.
16347722|NCT00283790|Drug|zolpidem tartrate|
16347723|NCT00283777|Drug|Chromium Picolinate|
16347724|NCT00283764|Drug|Xalatan|
16347725|NCT00283751|Drug|insulin detemir|
16347726|NCT00283751|Drug|insulin glargine|
16347727|NCT00283738|Device|BioSTAR Septal Repair Implant System|PFO Closure
16347728|NCT00283738|Procedure|Sham Procedure|Catheterization
16347729|NCT00283725|Other|No intervention|Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
16347730|NCT00283712|Drug|Infliximab|Chimeric IgG monoclonal antibody that binds to TNF-alpha, generally used to treat Crohn's disease, given in a dosage of 5 mg/kg
16347731|NCT00283712|Other|Placebo Comparator|Placebo administered in place of infliximab for control group
16347732|NCT00283699|Drug|albendazole|Active drug or placebo dosed bid p o for 8days
16347733|NCT00283699|Other|placebo|an inactive substance
16347734|NCT00283686|Drug|Lisinopril|Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
16347735|NCT00283686|Drug|Telmisartan|Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
16347736|NCT00283686|Drug|Placebo|Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
16347737|NCT00283686|Other|Standard Blood Pressure Control|Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
16347738|NCT00283686|Other|Low Blood Pressure Control|Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
16347739|NCT00283673|Behavioral|Exercise|
16347740|NCT00283660|Dietary Supplement|10 mg zinc oxide|10 mg zinc oxide
16347741|NCT00283660|Other|Placebo|Placebo pill taken five days a week for six months.
16347742|NCT00283634|Drug|erlotinib and bortezomib|
16347743|NCT00283621|Drug|Aranesp (darbepoetin alfa)|
16347744|NCT00283621|Drug|Neulasta (pegfilgrastim)|
16347745|NCT00283621|Drug|Adriamycin|
16347746|NCT00283621|Drug|Ifosfamide|
16347747|NCT00283608|Genetic|Single nucleotide polymorphism (SNP)|Evaluating SNP association with traits.
16347748|NCT00283608|Other|high performance liquid chromatography|analysis of plasma concentrations of drugs
16347749|NCT00283608|Other|measurements by DXA|determine bone mineral density (BMD)
16347750|NCT00283608|Other|questionnaire administration|determine attitude changes
16347751|NCT00283595|Drug|Recombinant Human Growth Hormone|Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
16347752|NCT00283595|Drug|Placebo for Recombinant Human Growth Hormone|Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
16347753|NCT00283582|Drug|rhTPO|
16347754|NCT00283569|Other|Mouth Swab, Toe Nail Clippings, Questionnaires|The objective of this study is to establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.
16347755|NCT00283556|Drug|Irinotecan (Camptosar, CPT-11)|"Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.
~Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached."
16347756|NCT00283543|Drug|Gliadel Wafer|
16347757|NCT00283543|Drug|Temozolomide|
16347758|NCT00283543|Procedure|Limited field radiation|
16347759|NCT00283530|Procedure|Tumor biopsy|
16347760|NCT00283517|Drug|antipsychotics|as prescribed
16347930|NCT00282126|Dietary Supplement|Potassium citrate|kcitrate
16357692|NCT00199017|Drug|Methotrexate|
16347761|NCT00283504|Drug|ANTI-IGE THERAPY (XOLAIR)|Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
16347762|NCT00283491|Behavioral|Active Lactobacillus plantarum 299v|10^11 cfu/meal in 2 meals on 2 consecutive days
16347763|NCT00283491|Dietary Supplement|Inactive Lactobacillus plantarum 299v|Inactive form of the active treatment but with the fermentation products in the same concentration
16347764|NCT00283478|Drug|Iscar Quercus|
16347765|NCT00283478|Drug|Gemcitabine|
16347766|NCT00283465|Drug|Epoetin alfa|
16347767|NCT00283452|Behavioral|Phone counseling with written materials|Participation in phone/mail counseling to maintain physical activity
16347768|NCT00283439|Biological|AMG 531|"Planned Cohorts:
~100 mcg,
~300 mcg,
~700 mcg,
~1000 mcg;
~Optional Cohorts:
~cohort expansion,
~schedule change,
~new dose"
16347769|NCT00283426|Drug|Soluble beta-1,3/1,6-glucan|
16347770|NCT00283413|Device|Covered Stent System|Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
16347771|NCT00283413|Device|Bare metal stent|Any commercially available bare metal stent for coronary indication
16347772|NCT00283400|Drug|25% human albumin|25% human albumin: after approval by the Data and Safety Monitoring Board dosage tier would be escalated to the subsequent higher level sequentially.
16347773|NCT00283387|Drug|Betaine|Subjects were randomly assigned oral betaine 12 grams/day in subjects younger than 10 years of age, and 20 grams/day in subjects 10 years of age and older, in two divided doses, for 2 months.
16347774|NCT00283387|Drug|Placebo|Subjects received oral lactose placebo, in two doses daily, for 2 months.
16347775|NCT00283374|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
16347776|NCT00283361|Drug|ZP120|
16347777|NCT00283361|Procedure|I.v. catherization|
16347778|NCT00283361|Procedure|6-minutes walk performance|
16347779|NCT00283361|Behavioral|Dyspnea severity assessment|
16347780|NCT00283361|Procedure|Blood sampling for laboratory tests|
16347781|NCT00283361|Procedure|ECG|
16347782|NCT00283361|Procedure|Physical examination|
16347783|NCT00283335|Drug|gemfibrozil|
16347784|NCT00283335|Other|Placebo|Matching placebo tablets taken once per day
16347785|NCT00283322|Other|blood samples (2)|Two blood samples were obtained from patients and tested for heparin antibodies.
16347786|NCT00283309|Drug|Memantine|
16347787|NCT00283309|Drug|Riluzole|
16347788|NCT00283296|Device|Endeavor|Collapsible, forward folding manual wheelchair
16347789|NCT00283283|Biological|Fluzone® (Aventis Pasteur inactivated influenza vaccine)|A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
16347790|NCT00283270|Behavioral|Brief counselling|
16347791|NCT00283270|Behavioral|Behavior|
16347792|NCT00283257|Behavioral|Patients and caregivers are taught problem solving skills|
16347793|NCT00283244|Drug|erlotinib hydrochloride|given orally
16347794|NCT00283244|Drug|gemcitabine hydrochloride|given IV
16347795|NCT00283231|Behavioral|Paced Respiration|
16347796|NCT00283218|Drug|NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70|
16347797|NCT00283205|Behavioral|Yoga|
16347798|NCT00283192|Drug|Sertraline|
16347799|NCT00283179|Drug|Aripiprazole|
16347800|NCT00283179|Drug|Risperidone|
16347801|NCT00283166|Behavioral|Tailored Education and Coaching|A: Patients receive one-on-one counseling and education about pain management and improving doctor-patient communication B: Patients receive booklet on cancer pain control
16347802|NCT00283153|Behavioral|Facial Affect Recognition Training|A series of pictures of faces displaying various emotions are presented one at a time using a computerized training program.Participants are taught to recognize how emotions affect facial features such as the mouth and eyes.Participants are also taught how to recognize their own emotions.
16347803|NCT00283153|Other|Stories of Emotional Inference|Participants are presented with a series of short stories one at a time. Each story presents various contextual cues regarding the emotions the characters are likely to experience. Participants learn to connect the cues to specific emotions.
16347804|NCT00283127|Procedure|Home sampling (urine test) for uro-genital C.trachomatis.|
16347805|NCT00283114|Drug|lintuzumab|1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles
16347806|NCT00283101|Drug|SGN-40 (anti-huCD40 mAb)|1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.
16347807|NCT00283088|Procedure|hypothermia|"Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
~Subjects are stratified by time to six groups."
16347808|NCT00283088|Drug|tissue plasminogen activator|tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
16347809|NCT00283075|Biological|Cancer Macrobead placement in abdominal cavity|8 macrobeads per kg
16347810|NCT00283062|Drug|Docetaxel (TAXOTERE®) Chemotherapy|"75 mg/m^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization.
~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."
16347811|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization.
16347812|NCT00283062|Drug|Docetaxel (TAXOTERE®) Chemotherapy|"75 mg/m^2 docetaxel administered IV over 1 hour on Day 1 q3w for 6 cycles. The first cycle was to be administered within 30 days after progression was confirmed.
~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."
16348050|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
16357693|NCT00199017|Drug|VP16|
16347813|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed (on Day 1 of docetaxel administration).
16347814|NCT00283062|Drug|Leuprolide acetate ( ELIGARD®) Hormonal Therapy|22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed.
16347815|NCT00283049|Drug|Insulin Glargine|Insulin glargine administered subcutaneously once daily.
16347816|NCT00283049|Drug|Insulin Glulisine|Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
16347817|NCT00283036|Drug|Irbesartan|
16347818|NCT00283023|Procedure|Oligodendrocyte progenitor cell culture/craniotomy|Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply
16347819|NCT00283010|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
16347820|NCT00283010|Other|Educational DVDs|
16347821|NCT00282997|Drug|pregabalin|
16347822|NCT00282984|Drug|placebo|1 mg placebo twice daily by mouth for 12 weeks
16347823|NCT00282984|Drug|Varenicline|1 mg twice daily by mouth for 12 weeks
16347824|NCT00282971|Drug|Inhaled Insulin (Exubera)|Addition of inhaled insulin to pre-existing oral diabetes therapy.
16347825|NCT00282971|Other|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
16347826|NCT00282958|Drug|Botulinum Toxin type a (Botox)|
16347827|NCT00282945|Drug|Rosiglitazone|
16347828|NCT00282945|Drug|Metformin|
16347829|NCT00282932|Drug|Detrol LA|
16347830|NCT00282919|Drug|Azithromycin plus chloroquine|dose of 2000 mg Azithromycin plus 600 mg chloroquine base
16347831|NCT00282906|Device|hybrid PET-CT imaging system|15 mCi of FDG
16347832|NCT00282893|Procedure|transluminal ballooning|
16347833|NCT00282893|Other|currently existing therapies for the treatment of vasospasm|
16347834|NCT00282867|Drug|IV glucose insulin and potassium, GIK|The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
16347835|NCT00282867|Other|standard care|usual care
16347836|NCT00282841|Other|ultrasound|single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.
16347837|NCT00282828|Drug|Sertraline|
16347838|NCT00282828|Drug|Venlafaxine|
16347839|NCT00282828|Drug|Placebo|
16347840|NCT00282828|Drug|Clonazepam|
16347841|NCT00282815|Device|continuous positive airway pressure or CPAP|RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
16347842|NCT00282815|Device|sham CPAP|sham CPAP
16347843|NCT00282789|Device|bilevel positive airway pressure|
16347844|NCT00282789|Device|bilevel positive airway pressure (Device)|
16347845|NCT00282776|Behavioral|Care Management for Postpartum Depression|Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care. In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available. Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well. Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum. They also receive information about community and health plan resources available for women with depression.
16347846|NCT00282776|Behavioral|TAU|Participants receive treatment as usual for postpartum depression. Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum. At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms. Women are also given phone contact numbers for the research program.
16347847|NCT00282763|Drug|MK0686|
16347848|NCT00282750|Device|Bar coded sponge and scanner|
16347849|NCT00282724|Drug|Liarozole|
16347850|NCT00282698|Drug|Insulin infusion with a goal|
16347852|NCT00282672|Device|Ablation System plus anti-secretory medication|Treatment group subjects undergo up to 4 ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI).
16347853|NCT00282672|Device|Sham procedure plus anti-secretory medication|The Sham Control group undergo an upper endoscopy procedure with sizing of the esophageal diameter (a component of the ablation procedure steps, deemed the sham procedure) plus standard anti-secretory drug therapy (Proton pump inhibitor, PPI)
16347854|NCT00282659|Drug|magnesium L-lactate|
16347857|NCT00282633|Device|Dermabond|
16347858|NCT00282620|Drug|Magnesium L-lactate|
16347859|NCT00282607|Drug|DA-8159|
16347860|NCT00282594|Drug|Novolin R (human recombinant Insulin)|
16347861|NCT00282581|Biological|MVA Smallpox Vaccine|0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
16347862|NCT00282568|Drug|Tacrolimus Modified Release (MR)|Oral
16347863|NCT00282568|Drug|tacrolimus|Oral
16347864|NCT00282555|Drug|S-Tenatoprazole-Na (STU-Na)|
16347865|NCT00282542|Procedure|Hepatocyte Infusion|
16347866|NCT00282529|Device|High Risk Lymphedema Education and Device Intervention|
16347867|NCT00282516|Procedure|In-home telemonitoring of pediatric patients with persistent asthma|
16347927|NCT00282152|Device|B-STN DBS|Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
16348113|NCT00281177|Behavioral|Asthma Disparity Reduction Strategy|
16347868|NCT00282503|Drug|Methoxsalen+ECP, Methylprednisolone|"Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:
~Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
~Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.)
~Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:
~Daily Dose (mg/kg)
~1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10"
16347869|NCT00282503|Procedure|Ecp|ECP or Extra Corporeal Phototherapy will be used with UVADex
16347870|NCT00282490|Device|Nerve stimulator|
16347871|NCT00282464|Drug|Placebo|Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.
16347872|NCT00282464|Drug|Geodon (Ziprasidone)|Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
16347873|NCT00282451|Drug|biphasic insulin aspart|
16347874|NCT00282451|Drug|insulin aspart|
16347875|NCT00282438|Biological|Autologous hematopoietic stem cell transplantation|Autologous hematopoietic stem cells will be injected after conditioning
16347876|NCT00282438|Biological|Allogeneic stem cell transplantation|Allogeneic stem cells will be injected after conditioning
16347877|NCT00282425|Biological|Hematopoietic stem cell transplantation|Allogeneic Hematopoietic stem cell transplantation
16347878|NCT00282412|Biological|Hematopoietic Stem Cell Transplantation|Allogeneic Hematopoietic Stem Cell Transplantation
16347879|NCT00282412|Drug|Fludarabine|inhibits DNA synthesis or repair
16347880|NCT00282412|Drug|Cyclophosphamide|Causes prevention of cell division by forming adducts with DNA
16347881|NCT00282412|Drug|Campath 1H|humanized monoclonal antibody against CD52 antigen
16347882|NCT00282412|Drug|GCSF|Hematopoietic growth factor
16347883|NCT00282412|Drug|Cyclosporins|immune suppressive drug
16347884|NCT00282412|Drug|Mycophenolate Mofetil|immune suppressive drug
16347885|NCT00282399|Drug|Subcutaneous Decitabine|
16347886|NCT00282386|Drug|MK0966; Rofecoxib / Duration of Treatment: 156 weeks|
16347887|NCT00282386|Drug|Placebo/ Duration of Treatment: 156 weeks|
16347888|NCT00282373|Device|mild hypothermia|
16347889|NCT00282360|Drug|Trimetazidine|
16347890|NCT00282347|Drug|Rituximab|Rituximab was provided as a sterile solution for injection.
16347891|NCT00282347|Drug|Placebo|Placebo was provided as a sterile solution for injection.
16347892|NCT00282347|Drug|Mycophenolate mofetil|
16347893|NCT00282347|Drug|Methylprednisolone|
16347894|NCT00282347|Drug|Diphenhydramine|
16347895|NCT00282347|Drug|Acetaminophen|
16347896|NCT00282347|Drug|Prednisone|
16347897|NCT00282334|Device|Telemedical blood pressure monitoring|Measurement of home blood pressure, three times per week for three months and once a week for three months.
16347898|NCT00282321|Behavioral|High Protein diet|
16347899|NCT00282321|Behavioral|High carbohydrate diet|
16347900|NCT00282308|Drug|Rituximab|Rituximab was supplied in single-use vials.
16347901|NCT00282308|Drug|Methotrexate|
16347902|NCT00282308|Drug|Methylprednisone|Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
16347903|NCT00282308|Biological|C. albicans|Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.
16347904|NCT00282308|Biological|Tetanus toxoid adsorbed booster vaccine|Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.
16347905|NCT00282308|Biological|23-valent pneumococcal polysaccharide vaccine|Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.
16347906|NCT00282308|Biological|Keyhole limpet hemocyanin|Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)
16347907|NCT00282295|Biological|Boostrix®|GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
16347908|NCT00282295|Biological|Menactra™|Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
16347909|NCT00282282|Drug|tacrolimus|Given orally just prior to and following stem cell transplant
16347910|NCT00282282|Drug|sirolimus|Given orally just prior to and following stem cell transplant
16347911|NCT00282282|Drug|fludarabine|Given once daily over 30 minutes for 4 days
16347912|NCT00282282|Drug|busulfex|Given intravenously over 3 hours for 4 days
16347913|NCT00282269|Procedure|Induced Hypothermia|Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours
16347914|NCT00282256|Drug|tacrolimus modified release (MR)|Oral
16347915|NCT00282256|Drug|tacrolimus|Oral
16347916|NCT00282243|Drug|tacrolimus modified release (MR)|Oral
16347917|NCT00282243|Drug|tacrolimus|Oral
16347918|NCT00282230|Drug|FK778|
16347919|NCT00282217|Drug|Sirolimus|
16347920|NCT00282204|Behavioral|antenatal hypnosis + audio compact disc on hypnosis|
16347921|NCT00282204|Behavioral|Audio compact disc on hypnosis|
16347922|NCT00282178|Drug|Hydrochlorothiazide|25-50 mg once daily
16347923|NCT00282178|Drug|Placebo|Once daily
16347924|NCT00282178|Drug|Candesartan|16-32 mg once daily 12 weeks
16347925|NCT00282165|Drug|naratriptan|four weeks double blind experimental treatment using oral naratriptan
16347926|NCT00282165|Drug|placebo|four weeks double blind placebo treatment
16347928|NCT00282152|Drug|Optimal drug therapy|The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
16347929|NCT00282139|Drug|Aripiprazole|
16347931|NCT00282113|Dietary Supplement|ProBioPlus|ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily.
16347932|NCT00282113|Dietary Supplement|Culturelle|Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.
16347933|NCT00282113|Other|Placebo|A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products
16347934|NCT00282100|Drug|Gefetinib (Iressa)|
16347935|NCT00282087|Drug|gemcitabine, docetaxel, doxorubicin|Cycles = 28 days
16347936|NCT00282074|Procedure|laparoscopic bilateral hernia repair|
16347937|NCT00282061|Drug|Melatonin|
16347938|NCT00282048|Drug|AG-013736 (axitinib)|AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
16347939|NCT00282035|Radiation|APBI utilizing 3D-CRT radiation|Accelerated partial breast irradiation utilizing 3D-CRT
16347940|NCT00282035|Radiation|Whole breast irradiation|Whole breast irradiation
16347941|NCT00282022|Drug|laromustine|
16347942|NCT00282009|Behavioral|Basic Internet|Basic Internet control intervention
16347943|NCT00282009|Behavioral|Enhanced Internet|enhanced Internet cessation intervention
16347944|NCT00282009|Behavioral|Enhanced Internet + phone|enhanced Internet plus proactive telephone counseling
16347945|NCT00281996|Drug|Gemcitabine|Administered intravenously over 30 minutes on days 1 and 8 of a 21-day cycle starting at a dose of 700 mg/m2 and increasing to 1000mg/m2 by cohorts
16347946|NCT00281996|Drug|Imatinib mesylate|Administered orally once daily with 8 ounces of water at a starting dose of 300 mg/day and increased to 600 mg/day according to cohort.
16347947|NCT00281983|Biological|alemtuzumab|
16347948|NCT00281983|Biological|anti-thymocyte globulin|
16347949|NCT00281983|Biological|filgrastim|
16347950|NCT00281983|Biological|rituximab|
16347951|NCT00281983|Biological|therapeutic allogeneic lymphocytes|
16347952|NCT00281983|Drug|busulfan|
16347953|NCT00281983|Drug|cyclophosphamide|
16347954|NCT00281983|Drug|cyclosporine|
16347955|NCT00281983|Drug|fludarabine phosphate|
16347956|NCT00281983|Drug|methotrexate|
16347957|NCT00281983|Drug|mycophenolate mofetil|
16347958|NCT00281983|Procedure|peripheral blood stem cell transplantation|
16347959|NCT00281983|Radiation|radiation therapy|
16347960|NCT00281970|Drug|cisplatin|
16347961|NCT00281970|Drug|docetaxel|
16347962|NCT00281970|Procedure|adjuvant therapy|
16347963|NCT00281957|Drug|sorafenib tosylate|Given orally
16347964|NCT00281957|Drug|tipifarnib|Given orally
16347965|NCT00281957|Drug|temsirolimus|Given IV
16347966|NCT00281944|Drug|oxaliplatin|Given IV
16347967|NCT00281944|Drug|fluorouracil|Given IV
16347968|NCT00281944|Drug|leucovorin calcium|Given IV
16347969|NCT00281944|Other|pharmacological study|Correlative studies
16347970|NCT00281944|Procedure|positron emission tomography|Undergo PET scan
16347971|NCT00281944|Procedure|computed tomography|Undergo PET/CT scan
16347972|NCT00281931|Biological|rituximab|
16347973|NCT00281931|Drug|cyclophosphamide|
16347974|NCT00281931|Drug|fludarabine phosphate|
16347975|NCT00281918|Drug|Rituximab|Intravenous repeating dose
16347976|NCT00281918|Drug|Cyclophosphamide|Intravenous repeating dose
16347977|NCT00281918|Drug|Fludarabine Phosphate|Intravenous repeating dose
16347978|NCT00281905|Drug|carboplatin|
16347979|NCT00281905|Drug|cisplatin|
16347980|NCT00281905|Drug|cyclophosphamide|
16347981|NCT00281905|Drug|methotrexate|
16347982|NCT00281905|Drug|vincristine sulfate|
16347983|NCT00281905|Radiation|radiation therapy|
16347984|NCT00281892|Biological|Fludarabine plus Darbopoetin|Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
16347985|NCT00281892|Drug|Fludarabine mono|"Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.
~Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa."
16347986|NCT00281879|Biological|anti-thymocyte globulin|Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein.
16347987|NCT00281879|Biological|filgrastim|"Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused.
~Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion."
16347988|NCT00281879|Drug|busulfan|Patients who take the drug PO, busulfan will be administered at 1 mg/kg/ dose given by mouth every 6 hours for 16 consecutive doses. Pediatric patients who receive busulfan IV continuous infusion will receive a dose of 3.0 mg/kg/IBW if under the age of 2.Pediatric patients over the age of 2 will receive busulfan at a dose of 0.8 mg/kg/dose.
16347989|NCT00281879|Drug|carmustine|300mg/m2 IV dissolved in 500 cc NS infused over 2 hours into right atrial catheter on day -6.
16347990|NCT00281879|Drug|cyclophosphamide|For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
16347991|NCT00281879|Drug|cyclosporine|Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID. The infusion will vary from 2-24hr depending on the incidence of side-effects.
16347992|NCT00281879|Drug|cytarabine|400 mg/m2 dissolved in 200cc D5W and infused over 30 minutes into right atrial catheter on days -5, -4, -3, -2.
16348051|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
16348052|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
16347993|NCT00281879|Drug|etoposide|"Etoposide administration 200 mg /m2 dissolved in 1 liter NS and infused over 2 hours into right atrial catheter. Infusion to begin after cytarabine administration on days -5, -4, -3, -2.
~Etoposide administration 50 mg/kg IV over 24 hours, divided into 3 doses. Dilute in normal saline at a concentration of 0.4 mg/ml (Observe for precipitation). Administered IV with continuous infusion over 24 hours. Diuretics may be given for fluid overload."
16347994|NCT00281879|Drug|fludarabine phosphate|"Fludarabine administered at 30 mg/m2 IVPB infused over 30 minutes into right atrial catheter on days -4, -3, -2.
~Fludarabine administered at 40 mg/m2 IVPB infused over 30 into the right atrial catheter on days -5, -4, -3, and -2."
16347995|NCT00281879|Drug|melphalan|140 mg /m2 in concentration of 0.45 mg/ml of NS infused over 30 minutes into right atrial catheter on day -1.
16347996|NCT00281879|Drug|methotrexate|Administered on days +1, +3, and +7.
16347997|NCT00281879|Drug|methylprednisolone|Methyl-prednisolone is administered IV as a rapid infusion.
16347998|NCT00281879|Drug|mycophenolate mofetil|Mycophenolate may be used as a substitute for Methotrexate
16347999|NCT00281879|Drug|tacrolimus|A drug used to decrease the risk of graft versus host disease (GvHD).
16348000|NCT00281879|Procedure|peripheral blood stem cell transplantation|The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy. The stem cell infusion takes 1-6 hours.
16348001|NCT00281879|Procedure|umbilical cord blood transplantation|The patient will receive ATG to improve the changes of engraftment and decrease their risk of graft versus host disease. The patient may receive ATG 3 times during their transplant regimen on days -3 through days -1
16348002|NCT00281879|Radiation|radiation therapy|Radiation will be given to you 2 times a day for 3 or 4 days.
16348003|NCT00281866|Drug|erlotinib hydrochloride|
16348004|NCT00281853|Procedure|management of therapy complications|Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
16348005|NCT00281840|Biological|bevacizumab|Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.
16348006|NCT00281840|Drug|docetaxel|docetaxel IV over 1 hour once a week for 8 weeks
16348007|NCT00281840|Procedure|conventional surgery|8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
16348008|NCT00281840|Radiation|radiation therapy|radiotherapy once daily, 5 days a week, for 8 weeks
16348009|NCT00281827|Drug|carboplatin|Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
16348010|NCT00281827|Drug|gemcitabine hydrochloride|Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
16348011|NCT00281827|Drug|thalidomide|Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
16348012|NCT00281827|Procedure|conventional surgery|Resection - between 2 and 6 weeks following last dose of chemotherapy.
16348013|NCT00281814|Procedure|psychosocial assessment and care|psychosocial assessment and care
16348014|NCT00281801|Procedure|psychosocial assessment and care|psychosocial assessment and care
16348015|NCT00281801|Procedure|Quality of Life Assessments|PACT Scale, Brief COPE, POMS Short Form and FACT BMT
16348016|NCT00281788|Drug|capecitabine|
16348017|NCT00281788|Drug|carboplatin|
16348018|NCT00281788|Drug|paclitaxel|
16348019|NCT00281788|Radiation|radiation therapy|
16348020|NCT00281762|Drug|NSAID|
16348021|NCT00281749|Procedure|TELEPHONE CALL|
16348022|NCT00281736|Drug|HPPH|Given IV
16348023|NCT00281723|Drug|Pro-Pe adhesive tablet|
16348024|NCT00281710|Drug|Methylprednisolone|
16348025|NCT00281697|Drug|Bevacizumab|The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.
16348026|NCT00281697|Drug|Placebo|
16348027|NCT00281697|Drug|Standard chemotherapy|"Patients received one of the following four standard chemotherapies for metastatic breast cancer.
~Taxane - Paclitaxel (Taxol) 90 mg/m^2 IV every week for 3 weeks followed by 1 week of rest; paclitaxel (Taxol) 175 mg/m^2 IV every 3 weeks, or paclitaxel protein-bound particles (Abraxane) 260 mg/m^2 IV every 3 weeks; or docetaxel (Taxotere) 75-100 mg/m^2 IV every 3 weeks.
~Gemcitabine (Gemzar) 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle.
~Vinorelbine (Navelbine) 30 mg/m^2 IV every week of each 3-week cycle.
~Capecitabine (Xeloda) 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week cycle."
16348028|NCT00281684|Drug|SB705498 400 mg|SB705498 400 mg
16348029|NCT00281684|Drug|SB705498 1000 mg|SB705498 1000 mg
16348030|NCT00281684|Drug|Placebo|Placebo
16348031|NCT00281684|Drug|Co-Codamol|Co-Codamol
16348032|NCT00281671|Drug|nesiritide|nesiritide 0.015 mcg/kg/hour x 10 hours
16348033|NCT00281671|Drug|Placebo|0.9% sodium chloride infusion
16348034|NCT00281658|Drug|lapatinib (GW572016) oral tablets|1500 mg oral daily continuously
16348035|NCT00281658|Drug|paclitaxel infusion|Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months
16348036|NCT00281645|Drug|Bicifadine|
16348037|NCT00281645|Drug|Standard of Care (pharmacological analgesic treatment)|
16348038|NCT00281632|Drug|GW786034|800 mg GW786034 administered orally on a daily basis.
16348039|NCT00281619|Drug|CellCept (mycophenolate mofetil)|
16348040|NCT00281619|Behavioral|Dietary Monitoring|
16348041|NCT00281619|Behavioral|Drug Diary|
16348042|NCT00281619|Procedure|Blood Sampling|
16348043|NCT00281606|Drug|Different formulations of once-daily lopinavir/ritonavir|CCTG585 is a randomized, open-label, two arm cross-over study to compare the tolerability of once daily LPV/r liquid versus capsules
16348044|NCT00281593|Drug|Telmisartan|
16348045|NCT00281593|Drug|Ramipril|
16348046|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
16348047|NCT00281580|Drug|Placebo|Placebo to Telmisartan and Amlodipine once daily for eight weeks
16348048|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
16348049|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
16348053|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
16348054|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
16348055|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
16348056|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5g once daily for eight weeks
16348057|NCT00281580|Drug|Telmisartan 20 mg|Telmisartan 20 mg once daily for eight weeks
16348058|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for eight weeks
16348059|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5mg once daily for eight weeks
16348060|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
16348061|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
16348062|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
16348063|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
16348064|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
16348065|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
16348066|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for two weeks
16348067|NCT00281580|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg once daily for eight weeks
16348068|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
16348069|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
16348070|NCT00281580|Drug|Amlodipine 5 mg|amlodipine 5g once daily for two weeks
16348071|NCT00281580|Drug|Amlodipine 5 mg|Amlodipine 5 mg once daily for eight weeks
16348072|NCT00281580|Drug|Telmisartan 40 mg|Telmisartan 40 mg once daily for eight weeks
16348073|NCT00281580|Drug|Telmisartan 80 mg|Telmisartan 80 mg once daily for eight weeks
16348074|NCT00281580|Drug|Amlodipine 10 mg|Amlodipine 10 mg once daily for six weeks
16348075|NCT00281567|Drug|Tiotropium|
16348076|NCT00281567|Device|Respimat SMI|
16348077|NCT00281567|Device|HandiHaler|
16348078|NCT00281554|Drug|RSD1235|IV
16348079|NCT00281541|Drug|YM155|
16348080|NCT00281528|Drug|ABI-007 (Abraxane)|30 minute infusions
16348081|NCT00281528|Drug|bevacizumab|infusions
16348082|NCT00281515|Drug|Lonafarnib|100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
16348083|NCT00281502|Drug|Rifaximin (drug)|Rifaximin 400mg three (3) times daily
16348084|NCT00281489|Device|BIS Monitor guided algorithm|BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
16348085|NCT00281489|Behavioral|Volatile anesthetic guided algorithm|Volatile anesthetic guided algorithm. Target anesthetic concentration 0.7 to 1.3 minimum alveolar concentration during anesthesia. Alarms when anesthetic concentration not in this range.
16348086|NCT00281476|Drug|Simvastatine|
16348087|NCT00281463|Device|Pushrim Activated Power Assist|The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation).
16348088|NCT00281450|Behavioral|Educational intervention|We developed a set of explicit criteria for pharmacological inappropriateness for Norwegian GPs' prescribing to elderly patients. The main purpose of the criteria was to serve as quality indicators during an educational intervention: the Prescription Peer Academic Detailing (Rx-PAD) Study, aimed at improving GPs' prescribing for elderly patients.
16348089|NCT00281437|Behavioral|choice of exercise program|
16348090|NCT00281424|Device|pedometer|gave pedometer and info
16348091|NCT00281411|Procedure|Computed Tomography Angiography|Computed Tomography Angiography
16348092|NCT00281411|Procedure|Magnetic Resonance Angiography|Magnetic Resonance Angiography
16348093|NCT00281398|Behavioral|Questionnaire|
16348094|NCT00281385|Behavioral|traditional vs. lifestyle exercise|
16348095|NCT00281359|Device|With heat|heat pad followed by dynamic splinting
16348096|NCT00281359|Device|No heat|No heat added to tissue prior to dynamic splinting
16348097|NCT00281346|Procedure|Doppler echocardiography|Echocardiography
16348098|NCT00281333|Behavioral|"Karate exercises and strengthening exercises"|
16348099|NCT00281320|Drug|Asenapine|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
16348100|NCT00281307|Drug|RRR-alpha-tocopherol 1,000 IU/mL|Intranasal application three times daily vs. placebo (inert excipient)
16348101|NCT00281294|Drug|Fontolizumab|
16348102|NCT00281281|Drug|vancomycin|
16348103|NCT00281268|Procedure|pulmonary artery catheter|
16348104|NCT00281268|Procedure|central venous catheter|
16348105|NCT00281268|Procedure|fluid management|
16348106|NCT00281255|Drug|Allopurinol|
16348107|NCT00281255|Drug|Dobutamine|
16348108|NCT00281242|Other|blood draw|All subjects undergo blood draws at study visits and at the time of COPD exacerbation visits.
16348109|NCT00281203|Procedure|blood drawing|blood will be drawn on the entry visit and will starting the intravenous (IV) line on the day of bronchoscopy
16348110|NCT00281203|Procedure|fiberoptic bronchoscopy|A flexible instrument will be passed through the mouth and into the lungs. Portions of the lungs will be washed, by injecting and immediately suctioning out a small amount of fluid. The entire return will be used for research purposes, and no results will be reported to the participant. Bronchoscopy is performed once.
16348111|NCT00281190|Procedure|Blood drawing|blood will be drawn at the time of starting the intravenous (IV) line for the procedure.
16348112|NCT00281190|Procedure|Bronchoalveolar lavage during indicated bronchoscopy|A small amount of liquid will be introduced and immediately sucked back out of portions of the lung, and the cells that are recovered will be analyzed in the laboratory. All test will be solely for research, and there will be no results reported to the subject from that fluid.
16348114|NCT00281125|Drug|PTK787 and Pemetrexed with or without Cisplatin|
16348115|NCT00281099|Device|ICD (Implantable Cardioverter Defibrillator)|VVI 40 vs. MVP
16348116|NCT00281073|Device|Intra-Cardiac Echocardiography guided Cardioversion|Intracardiac Echo and TEE
16348117|NCT00281073|Device|Intracardiac Echo|Intracardiac Echo Viewmate
16348118|NCT00281073|Device|ICE|ICE or TEE
16348119|NCT00281060|Procedure|primary stenting|
16348120|NCT00281047|Drug|FP-10|
16348121|NCT00281021|Drug|Erlotinib plus Digoxin|Each subject will receive erlotinib and digoxin daily until progression.
16348122|NCT00281008|Drug|ISIS 301012 or Placebo|50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348123|NCT00281008|Drug|ISIS 301012 or Placebo|100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348124|NCT00281008|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348125|NCT00281008|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
16348126|NCT00280995|Drug|ISIS 301012|100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348127|NCT00280995|Drug|ISIS 301012|200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348128|NCT00280995|Drug|ISIS 301012|300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85
16348129|NCT00280995|Drug|ISIS 301012|50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36
16348130|NCT00280982|Biological|tumor lysate-loaded autologous dendritic cells|50x10e6 cells per vaccination, 3 times, 2 weeks interval
16348131|NCT00280969|Drug|atazanavir arm|Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
16348132|NCT00280969|Drug|efavirenz|Patients are treated with efavirenz 300mg along with Epzicom.
16348133|NCT00280956|Drug|natalizumab|
16348134|NCT00280943|Behavioral|Long-term care facilities in the intervention arm will receive education and feedback audit on performance|
16348135|NCT00280930|Drug|Letrozole|
16348136|NCT00280917|Drug|CF101|
16348137|NCT00280904|Device|Shunt catheter|standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.
16348138|NCT00280878|Drug|gemcitabine|
16348139|NCT00280878|Drug|vinorelbine|
16348140|NCT00280878|Drug|ifosfamide|
16348141|NCT00280878|Drug|rituximab|
16348142|NCT00280865|Drug|Tesaglitazar|
16348143|NCT00280865|Drug|Pioglitazone|
16348144|NCT00280865|Behavioral|Dietary and Lifestyle Modification Counseling|
16348145|NCT00280826|Drug|Efalizumab|Participants who qualified for the study received weekly subcutaneous treatments of efalizumab, with the first dose being a test dose of 0.7 mg/kg and subsequent doses of 1 mg/kg (not to exceed 200 mg per dose), for a total treatment duration of 16 weeks.
16348146|NCT00280813|Behavioral|Supportive Treatment in Addiction Recovery (STAR)|
16348147|NCT00280800|Device|constant CPAP devices|different CPAP mode
16348148|NCT00280800|Device|automatic CPAP devices|different CPAP mode
16348149|NCT00280787|Drug|Paclitaxel|175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles
16348150|NCT00280787|Drug|Carboplatin|Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles.
16348151|NCT00280787|Drug|CPT-11|100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles.
16348152|NCT00280787|Drug|Pegfilgrastim|6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment.
16348153|NCT00280787|Radiation|Conformal radiotherapy|Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy
16348154|NCT00280774|Drug|Memantine|
16348155|NCT00280761|Drug|capecitabine|Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist
16348156|NCT00280761|Drug|5-fluorouracil|Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.
16348157|NCT00280761|Procedure|Surgical Resection|Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease).
16348158|NCT00280761|Radiation|Radiation therapy|Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.
16348159|NCT00280748|Drug|pemetrexed disodium|500 mg/m2 once every 21 days up to 126 days
16348160|NCT00280748|Radiation|radiation therapy|Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy
16348161|NCT00280735|Drug|carboplatin|Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
16348162|NCT00280735|Drug|docetaxel|75 mg/m² intravenously, once, every 3 weeks
16348163|NCT00280722|Behavioral|patient information leaflet|
16348164|NCT00280709|Device|"Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)"|Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
16348165|NCT00280696|Drug|Levetiracetam 250 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 250 mg
~Route of Administration: Oral Use"
16348166|NCT00280696|Drug|Levetiracetam 500 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 500 mg
~Route of Administration: Oral Use"
16348167|NCT00280696|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Film-coated tablet
~Concentration: 250 mg and 500 mg
~Route of Administration: Oral Use"
16348168|NCT00280683|Drug|L-arginine|subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months.
16348214|NCT00280293|Drug|Lamotrigine|Lamotrigine
16348169|NCT00280683|Drug|Placebo|Placebo tablets that match the L-arginine intervention tablets will be given for three months
16348170|NCT00280670|Behavioral|Cognitive-behavioral therapy|Cognitive behavioral therapy for children with autism and anxiety.
16348171|NCT00280657|Drug|Valette|1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
16348172|NCT00280657|Drug|Diane|1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
16348173|NCT00280657|Drug|Placebo|2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
16348174|NCT00280644|Drug|Leflunomide|
16348175|NCT00280631|Drug|Ezatiostat Hydrochlorine|Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.
16348176|NCT00280618|Drug|Oxaliplatin|
16348177|NCT00280605|Drug|Alfuzosin|
16348178|NCT00280592|Drug|Cranberry|Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).
16348179|NCT00280592|Drug|Placebo|Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
16348180|NCT00280566|Drug|Placebo|Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
16348181|NCT00280566|Drug|Ziprasidone Oral Capsule|Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
16348182|NCT00280553|Drug|bupivicaine|PCA and bupivicaine infusion for up to five days
16348183|NCT00280553|Other|Saline infusion|PCA and pump with saline infusion for up to five days
16348184|NCT00280540|Drug|Valsartan/Hydrochlorothiazide|
16348185|NCT00280514|Drug|cefpirome and moxifloxacin administration|
16348186|NCT00280501|Drug|Quetiapine (drug)|Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose
16348187|NCT00280501|Drug|Sulpiride (drug)|Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose
16348188|NCT00280501|Drug|Placebo|Placebo
16348189|NCT00280488|Behavioral|Motivational Interview|Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
16348190|NCT00280488|Behavioral|Assessment|In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
16348191|NCT00280488|Behavioral|Motivational Interview|Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
16348192|NCT00280475|Device|Whole brain radiation therapy arm|Whole brain radiation therapy arm
16348193|NCT00280475|Device|Salvage stereotactic radiosurgery arm|Salvage stereotactic radiosurgery arm
16348194|NCT00280462|Drug|Nifedipine (drug)|Nifedipine (Adalat®, Bayer, Leverkusen, Germany) dose: 15µg/kg bolus infusion over 5 minutes; 0.2 µg/(kg.min) maintenance dose infusion period 25 minutes
16348195|NCT00280462|Drug|L-Arginin (drug)|L-Arginin (Clinalfa AG, Läufelfingen, Switzerland) 30% sodium chlorid solution, dose: 1g/min over 30 minutes
16348196|NCT00280462|Drug|Placebo|Placebo
16348197|NCT00280449|Behavioral|strengths-based case managed proactive service model|
16348198|NCT00280436|Drug|GW679769|
16348199|NCT00280423|Drug|GW679769|
16348200|NCT00280410|Drug|E7337|
16348201|NCT00280397|Drug|E7080|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
16348202|NCT00280384|Drug|E2014 (Botulinum toxin type B)|A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
16348203|NCT00280384|Drug|E2014 (Botulinum toxin type B) Placebo|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
16348204|NCT00280371|Drug|Formoterol Fumarate|
16348205|NCT00280358|Drug|Fluticasone Propionate|
16348206|NCT00280358|Drug|Formoterol Fumarate|
16348207|NCT00280345|Procedure|Trabeculectomy|A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork
16348208|NCT00280345|Procedure|Trabeculectomy and cataract surgery|A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork and the removal of the cataract
16348209|NCT00280345|Procedure|Cataract surgery|Removal of the cataract from the eye
16348210|NCT00280332|Procedure|colonoscopy|proform a follow up colonoscopy in the 5 year period from index colonoscopy
16348211|NCT00280319|Behavioral|interpersonal psychotherapy for groups|psychotherapy
16348212|NCT00280319|Behavioral|creative play therapy|consisted of play activities
16348213|NCT00280306|Other|No interventions|No intervention
16348215|NCT00280293|Drug|Placebo|Placebo
16348216|NCT00280280|Drug|intramuscular Botox versus oral baclofen|Each vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets.
16348217|NCT00280267|Drug|Testosterone gel|
16348218|NCT00280254|Procedure|Hemodynamically Oriented Echocardiography-based Strategy|
16348219|NCT00280241|Drug|Fludarabine|Fludarabine is usually administered by IV infusion over 30 minutes or longer.
16348220|NCT00280241|Drug|Cyclophosphamide|The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
16348221|NCT00280241|Drug|Rituximab|First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
16348222|NCT00280228|Behavioral|Adolescent Skills Parent Management Parent-Adol Negotiation|Acute treatment for 12 weeks followed by three monthly booster sessions.
16348223|NCT00280228|Behavioral|Treatment as Usual|Standard outpatient treatment for behavioral problems and substance use
16348224|NCT00280215|Drug|ACEI / Angiotensin converting enzyme inhibitor|Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker, Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
16348225|NCT00280215|Drug|ARB /Angiotensin Receptor Blocker|Patients will be randomized to a combination of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker,Patients will be randomized to a combination of ARB(losartan 50 mg daily in adult patients, 0.7 mg/kg/day in patients < 40 kg) ACE-I (lisinopril 10 mg daily in adult patients, 0.15 mg/kg/day in pediatric patients < 40 kg) to be taken for 24 months.
16348226|NCT00280215|Drug|Placebo|Patients will receive placebo for 24 months
16348227|NCT00280202|Procedure|Biopsy of the major carinal area|Biopsy performed intraoperatively
16348228|NCT00280202|Procedure|Biopsy of abnormal & suspicious areas of the bronchial tree|Biopsy performed intraoperatively
16348229|NCT00280202|Procedure|Evaluation of the tumor for DNA mutations|Tumor tissue is banked for future analysis.
16348230|NCT00280202|Procedure|Bronchoalveolar Lavage (BAL) for cytokine analysis|BAL performed intraoperatively
16348231|NCT00280202|Procedure|Correlation of flow cytometric & RT PCR for TNM stage|Tissues banked for future correlative studies
16348232|NCT00280202|Procedure|Analysis of lymph nodes|Tissues banked for future analysis
16348233|NCT00280189|Procedure|Radiofrequency ablation of pulmonary malignancies|Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
16348234|NCT00280189|Behavioral|Quality of life assessment|Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.
16348235|NCT00280189|Behavioral|Assessment of pain|Pain scores are obtained prior to the procedure, daily X 7 starting on the day of surgery, and then every 3 months for 1 year.
16348236|NCT00280176|Drug|bortezomib|0.7mg/m2 - 1.5mg.m2 given during Weeks 1, 2, 4 and 5 on a Monday/Thursday or Tuesday/Friday schedule, up to six weeks
16348237|NCT00280176|Drug|fluorouracil|225mg/m2 given weekly, up to 6 weeks
16348238|NCT00280176|Radiation|radiation therapy|180 cGy, every 5 days, up to six weeks
16348239|NCT00280150|Biological|bevacizumab|Given IV
16348240|NCT00280150|Drug|carboplatin|Given IV
16348241|NCT00280150|Drug|erlotinib hydrochloride|Given orally
16348242|NCT00280150|Drug|paclitaxel|Given IV
16348243|NCT00280150|Radiation|3-dimensional conformal radiation therapy|Given 5 days a week for 7 weeks
16348244|NCT00280111|Biological|116E AGMK|Single dose of 116E 10^5 FFu
16348245|NCT00280111|Drug|I321|Single dose of I321 10^5 FFu
16348246|NCT00280111|Drug|Placebo|1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine
16348247|NCT00280098|Drug|docetaxel|Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid
16348248|NCT00280085|Procedure|MR imaging|
16348249|NCT00280085|Procedure|Glucose clamp|
16348250|NCT00280085|Drug|Arginine|
16348251|NCT00280072|Device|Renal Assist Device|
16348252|NCT00280059|Drug|Pregabalin|dose 150-600 mg/day given BID
16348253|NCT00280059|Drug|Lamotrigine|dose 100-500 mg/day given BID
16348254|NCT00280046|Drug|biphasic insulin aspart|
16348255|NCT00280033|Biological|Aluminum hydroxide|Provided in vials that contain 0.8 mL volume per vial.
16348256|NCT00280033|Biological|Inactivated Influenza A/H5N1 Vaccine (Chiron)|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg.
16348257|NCT00280033|Biological|MF-59|Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial.
16348258|NCT00280033|Drug|Placebo|Saline placebo.
16348259|NCT00280020|Behavioral|Tai Chi Chih (TCC)|Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
16348260|NCT00280020|Behavioral|Cognitive Behavior Therapy (CBT)|For each 2-hour session held once a week for 16 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
16348261|NCT00280020|Behavioral|Sleep Seminar (SS)|Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion.
16348262|NCT00280007|Drug|bevacizumab|bevacizumab 5 mg/kg i.v. every 14 days for 52 weeks
16348263|NCT00279994|Procedure|Exercise therapy|
16357694|NCT00199017|Drug|Vindesine|
16348264|NCT00279994|Device|Accelerometer (PAM; Personal Activity Monitor)|
16348265|NCT00279994|Procedure|Oral Exercise Therapy advise|
16348266|NCT00279981|Device|Diagnostic|
16348267|NCT00279968|Device|ICD|
16348268|NCT00279955|Device|Cardiac Resynchronization Therapy Device|Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.
16348269|NCT00279942|Dietary Supplement|Soy|Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
16348270|NCT00279942|Other|Placebo|Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
16348271|NCT00279929|Procedure|DHEA Replacement|
16348272|NCT00279916|Drug|Triamcinolone acetonide nasal spray|"Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms).
~Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms)."
16348273|NCT00279916|Drug|Placebo nasal spray|"Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily.
~Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily."
16348274|NCT00279903|Drug|Botulinum toxin type A (Btx-A)|Participants randomized to Btx-A will be given either a low dose of 100 units or a high dose of 200 units. The Btx-A dose (100U or 200U) will be resonstituted with 4 cc of sterile non-preserved 0.9% sodium chloride solution.
16348275|NCT00279903|Drug|Cortisone|1 cc of 40 mg/cc methylprednisolone will be drawn up in 22 gauge needles with 3 cc of sterile non-preserved 0.9% sodium chloride solution.
16348276|NCT00279890|Drug|Topical SR-01|
16348277|NCT00279877|Procedure|Kyphoplasty|kyphoplasty
16348278|NCT00279838|Procedure|Computer Assisted Navigation Knee Replacement|
16348279|NCT00279825|Drug|IPX054 200 mg|IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
16348280|NCT00279825|Drug|IPX054 250 mg|IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
16348281|NCT00279825|Drug|CD-LD IR|Active comparator containing 25 mg carbidopa and 100 mg levodopa
16348282|NCT00279825|Drug|CD-LD CR|Active comparator containing 50 mg carbidopa and 200 mg levodopa
16348283|NCT00279825|Drug|IPX054 200 mg Placebo|Placebo to match IPX054 200 mg
16348284|NCT00279825|Drug|IPX054 250 mg Placebo|Placebo to match IPX054 250 mg
16348285|NCT00279825|Drug|CD-LD IR Placebo|Placebo to match CD-LD IR
16348286|NCT00279825|Drug|CD-LD CR Placebo|Placebo to match CD-LD CR
16348287|NCT00279812|Dietary Supplement|50ug selenium enriched yeast|Selenomethionine supplement (50ug/d Se) for 12 weeks
16348288|NCT00279812|Dietary Supplement|100ug selenium enriched yeast|Selenomethionine supplement (100ug/d Se) for 12 weeks
16348289|NCT00279812|Dietary Supplement|200ug selenium enriched yeast|Selenomethionine supplement (200ug/d Se) for 12 weeks
16348290|NCT00279812|Dietary Supplement|Control onion|3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
16348291|NCT00279812|Dietary Supplement|Enriched onion|3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
16348292|NCT00279812|Other|Placebo|Placebo supplement for 12 weeks
16348293|NCT00279799|Behavioral|Afiya HIV Prevention Intervention|Group-based session plus individually tailored HIV prevention phone sessions
16348294|NCT00279799|Behavioral|Afiya HIV prevention intervention|Afiya group-based intervention + nutrition phone sessions (attention control)
16348295|NCT00279786|Procedure|Blood draw|blood drawn
16348296|NCT00279773|Drug|TKI258|
16348297|NCT00279760|Drug|Belatacept|
16348298|NCT00279760|Drug|Abatacept|
16348299|NCT00279747|Drug|meloxicam 0.25 mg/kg|
16348300|NCT00279747|Drug|meloxicam 0.125 mg/kg|
16348301|NCT00279747|Drug|naproxen 10 mg/kg|
16348302|NCT00279734|Drug|Tetanus + pnemococcal vaccines alone|0 mg + vaccines, Single dose, 28 days.
16348303|NCT00279734|Drug|Abatacept + vaccines|Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
16348304|NCT00279734|Drug|Abatacept + vaccines|Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
16348305|NCT00279734|Drug|Abatacept + Vaccines|parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
16348306|NCT00279721|Procedure|IMRT|
16348307|NCT00279708|Drug|Atorvastatin|Placebo vs. Atorvastatin
16348308|NCT00279708|Other|Placebo Oral Tablet|Placebo: Sham Therapy in an oral tablet formulation
16348309|NCT00279695|Procedure|high frequency ultrasound examination|high frequency ultrasound examination of the eye
16348310|NCT00279682|Behavioral|treatment guidelines and depression care management|
16348311|NCT00279669|Procedure|Ultrasound examination|contact ultrasound examination
16348312|NCT00279656|Behavioral|Pharmaceutical care|
16348313|NCT00279643|Procedure|Laser Hair Removal|
16348314|NCT00279630|Procedure|Orthoses and Exercise|orthrose and exercise - daily
16348315|NCT00279617|Drug|levetiracetam|open label levetricetam
16348316|NCT00279604|Behavioral|'Problem Profile Intervention' vs. WHO-Brief Intervention|
16348317|NCT00279591|Device|Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device|Continuous blood pressure monitoring of patients during med flight to hospital
16348318|NCT00279591|Device|Standard of care blood pressure monitoring|Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.
16348319|NCT00279578|Drug|ReFacto (Recombinant factor VIII) and Tranexamic acid|
16348320|NCT00279565|Drug|buprenorphine|
16348321|NCT00279565|Drug|methadone|
16348322|NCT00279565|Drug|pegylated interferon alfa-2b plus ribavirin|
16348323|NCT00279552|Drug|Recombinant human intrinsic factor|
16348324|NCT00279539|Genetic|Vascular Endothelial Growth Factor (VEGF1)|
16348325|NCT00279513|Drug|Traumeel S|
16348326|NCT00279500|Device|Argus 16 Retinal Stimulation System|The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
16348327|NCT00279487|Drug|Gabapentin|
16348328|NCT00279487|Drug|Placebos|
16348329|NCT00279474|Behavioral|cognitive-behavior groups|
16348330|NCT00279461|Drug|Placebo in arm A and Vitamin D in arm B|Vitamin D3 at 2,000 units daily, all in one capsule, for 6 months and Placebo provided in matching capsule, one capsule daily, for 6 months
16348331|NCT00279461|Drug|vitamin D 3 for arm A ,and matching placebo for arm B|Arm A 2,000 units of Vitamin D3 in one capsule daily for 6 months. Arm B matching placebo capsule, one daily for 6 months
16348332|NCT00279448|Drug|exemestane|On tablet of 25 mg per day during 5 years
16348333|NCT00279448|Drug|tamoxifen|Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment
16348334|NCT00279435|Drug|visilizumab|
16348335|NCT00279422|Drug|visilizumab|
16348336|NCT00279422|Drug|visilizumab|
16348337|NCT00279409|Drug|aripiprazole|double blind capsules (abilify or placebo) taken once daily, up to 10mg.
16348338|NCT00279409|Drug|Sugar pill|double blind capsules (abilify or placebo) taken once daily, up to 10mg.
16348339|NCT00279383|Drug|Fibrinogen (human) + thrombin (human) (TachoSil)|Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
16348340|NCT00279357|Procedure|Narrow Band Imaging|
16348341|NCT00279344|Drug|Fentanyl (Matrifen)|
16348342|NCT00279305|Drug|Anti-CD20 (rituximab)|
16348343|NCT00279305|Drug|Placebo Comparator|Placebo intravenous infusion
16348344|NCT00279292|Procedure|Celiac Plexus Neurolysis|
16348345|NCT00279279|Device|Implanted Device|
16348346|NCT00279266|Drug|Thiamine|
16348347|NCT00279253|Drug|clonidine (drug) intravenously|
16348348|NCT00279240|Drug|Metformin|
16348349|NCT00279214|Drug|drotrecogin alfa (activated)|
16348350|NCT00279201|Drug|Insulin glargine|Subcutaneous injection daily
16348351|NCT00279201|Drug|Lispro Low Mix|Subcutaneous injection twice daily.
16348352|NCT00279201|Drug|Lispro Mid Mix|Lispro Mid Mix subcutaneous injection 3 times daily.
16348353|NCT00279201|Drug|Lispro|Lispro subcutaneous injection 3 times daily.
16348354|NCT00279188|Procedure|Guiding therapy by bronchial hyperrsponsiveness|
16348355|NCT00279175|Biological|Intracoronary infusion of enriched bone marrow-derived progenitor cells|
16348356|NCT00279175|Biological|Placebo medium supplemented with autologous serum|
16348357|NCT00279162|Drug|Calcipotriene/betamethasone gel and ointment|
16348358|NCT00279149|Procedure|Visio conference system connected to the Tele-stroke network|Visio conference system connected to the Tele-stroke network
16348359|NCT00279123|Drug|pantoprazole infusion|
16348360|NCT00279123|Drug|pantoprazole bolus|
16348361|NCT00279123|Drug|no treatment|
16348362|NCT00279110|Behavioral|Directly administered antiretroviral therapy (DAART)|Participants are observed taking HIV medications on days when they receive opioid agonist therapy.
16348363|NCT00279097|Device|High Frequency Chest Wall Oscillation|
16348364|NCT00279084|Drug|GROUP A: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/L.|
16348365|NCT00279084|Drug|GROUP B: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/L|
16348366|NCT00279071|Device|Acupuncture og acupressure when diagnosed with dystocia|Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
16348367|NCT00279058|Procedure|Immunotherapy treatment for melanoma|
16348368|NCT00279045|Drug|Rosiglitazone|
16348369|NCT00279045|Drug|glyburide|
16348370|NCT00279045|Drug|metformin|
16348371|NCT00279032|Drug|GW406381|
16348372|NCT00279019|Drug|GSK233705|GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
16348373|NCT00279019|Drug|Tiotropium|Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
16348374|NCT00279019|Drug|Placebo|Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
16348375|NCT00279006|Procedure|Percutaneous coronary intervention|
16348376|NCT00278993|Drug|E7389|Intravenous 1.4 mg/m2 on a 3-week course.
16348377|NCT00278980|Drug|C-peptide|
16348378|NCT00278967|Drug|HalfLytely with Bisacodyl Tablets Bowel Prep Kit|
16348379|NCT00278967|Drug|HalfLytely - Reformulation|
16348380|NCT00278954|Biological|Gammaplex (Intravenous immunoglobulin)|GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously for 12 months.
16348381|NCT00278941|Drug|Quetiapine Fumarate Sustained Release|
16348382|NCT00278928|Drug|Liposyn III 20% (lipid infusion)|
16348383|NCT00278928|Drug|Intralipid 20% (lipid infusion)|
16348385|NCT00278902|Drug|ARRY-334543, EGFR/ErbB2 inhibitor; oral|Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
16348386|NCT00278889|Drug|AZD2171|oral tablet
16348387|NCT00278889|Drug|5-fluorouracil|intravenous infusion
16348388|NCT00278889|Drug|Leucovorin|intravenous infusion
16348389|NCT00278889|Drug|Oxaliplatin|intravenous infusion
16348390|NCT00278889|Drug|Bevacizumab|intravenous infusion
16348391|NCT00278876|Drug|Imatinib mesylate (Glivec)|Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
16348392|NCT00278863|Drug|S-1|
16348393|NCT00278863|Drug|Capecitabine|
16348394|NCT00278850|Behavioral|Educational|three 1 hour long educational seminars
16348395|NCT00278837|Behavioral|Mindfulness based meditation program|Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
16348396|NCT00278824|Drug|Matrix Transdermal Fentanyl/CHADD Drug Delivery System|Patch applied every 3 days for 15 days
16348397|NCT00278824|Drug|Placebo Patch|Placebo patch applied every 3 days for 15 days
16348398|NCT00278811|Procedure|mobile crisis team|
16348399|NCT00278785|Behavioral|Brief Motivational Interview|10-20 minute brief motivational interview
16348400|NCT00278772|Drug|Divalproex|oral, 15mg/kg/day - 30mg/kg/day
16348401|NCT00278772|Other|Placebo|oral dose, placebo
16348402|NCT00278759|Procedure|Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.|See Detailed Description.
16348403|NCT00278746|Drug|Zinc and ORS|Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities
16348404|NCT00278746|Drug|ORS only|Promoted routine management of diarrhea in underfive with ORS
16348405|NCT00278733|Behavioral|Brief intervention (physician advice)|
16348406|NCT00278707|Drug|GTA: Glyceryltriacetate|
16348407|NCT00278694|Drug|Oxaliplatin|
16348408|NCT00278694|Drug|Chemoradiation|
16348409|NCT00278694|Drug|5-FU|
16348410|NCT00278694|Radiation|Preoperative chemoradiation|
16348411|NCT00278694|Procedure|Pelvic surgery|
16348412|NCT00278694|Drug|Neoadjuvant oxaliplatin|
16348413|NCT00278681|Drug|Zinc and ORS|"One strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea.
~Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water."
16348414|NCT00278655|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
16348415|NCT00278642|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
16348416|NCT00278629|Biological|hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
16348417|NCT00278616|Biological|Stem Cell Transplantation|Autologous Stem Cell Transplantation
16348418|NCT00278603|Biological|Stem Cell Transplantation|Autologous Hematopoietic Stem Cell Injection
16348419|NCT00278590|Biological|Allogeneic Stem Cell Transplantation|Allogeneic stem cell transplantation will be performed.
16348420|NCT00278577|Biological|Immune Ablation and Hematopoietic Stem Cell Support|Autologous Hematopoietic Stem Cell Transplant
16348421|NCT00278564|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
16348422|NCT00278564|Drug|Cyclophosphamide|
16348423|NCT00278564|Drug|Mesna|
16348424|NCT00278564|Drug|ATG(rabbit)|
16348425|NCT00278564|Drug|Methylprednisolone|
16348426|NCT00278564|Drug|G-CSF|
16348427|NCT00278564|Drug|Rituxan|
16348428|NCT00278551|Biological|Immune ablation and hematopoietic stem cell transplant|Autologous Hematopoietic Stem Cell Transplant
16348429|NCT00278538|Biological|Hematopoietic stem cell transplantation|Autologous hematopoietic stem cell transplantation
16348430|NCT00278525|Drug|standard of care|standard of care medication will be given
16348431|NCT00278525|Procedure|stem cell transplantation|The following is intervention: stem cell transplantation after conditioning regimen
16348432|NCT00278512|Biological|Autologous Stem Cell Transplant|Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning
16348433|NCT00278512|Biological|Allogeneic Stem Cell Transplant|Allogeneic Stem Cell Transplant will be performed after conditioning
16348434|NCT00278512|Drug|Cyclophosphamide|Causes prevention of the cell division
16348435|NCT00278512|Drug|ATG (rabbit)|A rabbit polyclonal antibody to lymphocyte
16348436|NCT00278512|Drug|G-CSF|Hematopoietic growth factor
16348437|NCT00278512|Drug|Campath-1h|Humanized monoclonal antibody against CD52 antigen
16348438|NCT00278512|Drug|Fludarabine|inhibits DNA synthesis or repair
16348439|NCT00278512|Drug|Tacrolimus|immune suppressive drug
16348440|NCT00278512|Drug|Mesna|Mesna is a drug used to protect the bladder from the effects of the chemotherapy drugs
16348441|NCT00278499|Behavioral|Cross-sectional surveys|Cross-sectional surveys will occur at study entry, Month 6, and Month 12. Every fourth participant enrolled in the FSW cross-sectional survey, all FSWs found to be HIV infected, and all FSWs who are intravenous drug users will participate in a substudy lasting 12 months.
16348442|NCT00278499|Behavioral|Questionnaire/counseling|An initial questionnaire and counseling will occur once in addition to post-test counseling.
16348443|NCT00278486|Biological|Hematopoietic stem cell transplantation.|Autologous hematopoietic stem cell transplantation will be performed.
16348444|NCT00278473|Behavioral|Meta-Cognitive Therapy|Cognitive Behavioral Group Treatment
16348445|NCT00278473|Behavioral|Supportive Therapy|Social Support Problem-Solving Group Treatment
16348446|NCT00278460|Drug|docetaxel|40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
16348447|NCT00278460|Drug|gemcitabine hydrochloride|800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
16348448|NCT00278447|Behavioral|Chronic Disease Management for substance abuse|Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
16348449|NCT00278447|Behavioral|Standard care|Referral to primary medical care for persons with substance dependence.
16348450|NCT00278434|Drug|Zoledronate|
16348451|NCT00278434|Other|Placebo (Saline)|
16348452|NCT00278421|Biological|rituximab|
16348453|NCT00278421|Drug|cyclophosphamide|
16348454|NCT00278421|Drug|doxorubicin hydrochloride|
16348455|NCT00278421|Drug|prednisone|
16348456|NCT00278421|Drug|vincristine sulfate|
16348457|NCT00278408|Biological|filgrastim|
16348458|NCT00278408|Biological|rituximab|
16348459|NCT00278408|Drug|cyclophosphamide|
16348460|NCT00278408|Drug|doxorubicin hydrochloride|
16348461|NCT00278408|Drug|prednisone|
16348462|NCT00278408|Drug|vincristine sulfate|
16348463|NCT00278408|Radiation|radiation therapy|
16348464|NCT00278395|Drug|Vorinostat|Given orally
16348465|NCT00278382|Drug|sorafenib tosylate|Given orally
16348466|NCT00278382|Other|laboratory biomarker analysis|Correlative studies
16348599|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
16348600|NCT00277225|Drug|Abatacept|
16357695|NCT00199017|Drug|Adriamycin|
16348467|NCT00278369|Biological|aldesleukin|The IL-2 is given as a 15-minute infusion through an intravenous catheter (I.V.), a small plastic tube that is put into your vein for the time you are receiving the study treatment. IL-2 is given through the I.V. once every 8 hours for 5 days (days 1-5). A second 5 day cycle of IL-2 will begin on the 15th day (days 15-19). This is one complete cycle (days 1-19) of IL-2 treatment
16348468|NCT00278369|Biological|denileukin diftitox|Denileukin diftitox will be administered once daily as a 15 to 60 minute infusion for 3 consecutive days.
16348469|NCT00278343|Drug|cediranib maleate|30mg given PO, daily
16348470|NCT00278343|Other|laboratory biomarker analysis|Correlative studies
16348471|NCT00278330|Drug|alvocidib|Given by infusion
16348472|NCT00278330|Drug|vorinostat|Given orally
16348473|NCT00278304|Radiation|brachytherapy|
16348474|NCT00278304|Radiation|radiation therapy|
16348475|NCT00278278|Drug|cisplatin|Given IV
16348476|NCT00278278|Drug|etoposide|Given IV
16348477|NCT00278278|Drug|ifosfamide|Given IV
16348478|NCT00278278|Drug|lomustine|Given IV
16348479|NCT00278278|Drug|methotrexate|Given IV
16348480|NCT00278278|Drug|prednisone|Given IV
16348481|NCT00278278|Drug|vincristine sulfate|Given IV
16348482|NCT00278265|Drug|MTX followed by fludarabine|MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles
16348483|NCT00278252|Drug|etoposide|
16348484|NCT00278252|Procedure|conventional surgery|
16348485|NCT00278239|Procedure|cognitive assessment|
16348486|NCT00278239|Procedure|psychosocial assessment and care|
16348487|NCT00278239|Procedure|quality-of-life assessment|
16348488|NCT00278226|Behavioral|smoking cessation intervention|
16348489|NCT00278226|Other|educational intervention|
16348490|NCT00278213|Biological|alemtuzumab|
16348491|NCT00278213|Drug|cyclophosphamide|
16348492|NCT00278213|Drug|fludarabine phosphate|
16348493|NCT00278213|Drug|mitoxantrone hydrochloride|
16348494|NCT00278200|Biological|Inactivated EBV-infected vaccine|
16348495|NCT00278187|Biological|volociximab|
16348496|NCT00278187|Drug|erlotinib hydrochloride|
16348497|NCT00278174|Biological|recombinant interferon alpha-1b|
16348498|NCT00278161|Biological|Pegfilgrastim|6 mg SQ 24-48 hours after last dose of cyclophosphamide.
16348499|NCT00278161|Biological|Rituximab|375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.
16348500|NCT00278161|Drug|Cyclophosphamide|50 mg/kg/day on Days 15, 16, 17, and 18.
16348501|NCT00278148|Drug|carboplatin|AUC2 weekly x 3 weeks
16348502|NCT00278148|Drug|Erlotinib|Daily
16348503|NCT00278148|Drug|paclitaxel|50mg/m2/weekly x 3 weeks
16348504|NCT00278148|Procedure|conventional surgery|conventional surgery
16348505|NCT00278148|Radiation|radiation therapy|150 cGy bid
16348506|NCT00278135|Dietary Supplement|DHA (nutritional supplement) or placebo|oral 900mg/day
16348507|NCT00278122|Biological|sargramostim|
16348508|NCT00278122|Drug|paclitaxel|
16348509|NCT00278109|Drug|cyclophosphamide|chemotherapy
16348510|NCT00278109|Drug|Doxorubicin|doxorubicin
16348511|NCT00278109|Radiation|radiation|radiation
16348512|NCT00278096|Behavioral|occupational therapy|
16348513|NCT00278083|Drug|Study drug administration|
16348514|NCT00278083|Procedure|Tuberculin intradermal skin test|
16348515|NCT00278083|Procedure|Lung function test for FEV1|
16348516|NCT00278083|Procedure|Asthma symptom scores diary|
16348517|NCT00278083|Procedure|Quality of life diary|
16348518|NCT00278083|Procedure|Breath nitric oxide|
16348519|NCT00278083|Procedure|Breath condensate|
16348520|NCT00278083|Procedure|Sputum induction|
16348521|NCT00278083|Procedure|Blood sampling|
16348522|NCT00278083|Procedure|Urinalysis|
16348523|NCT00278070|Drug|vinorelbine oral formulation|Patients will take three times a week [Monday, Wednesday and Friday] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure
16348524|NCT00278057|Drug|dialysisis with and without glucose in the dialysis|
16348525|NCT00278044|Procedure|blood sampling and medical records|
16348526|NCT00278018|Procedure|Immunotherapy treatment for solid tumors|
16348527|NCT00277914|Drug|Flibanserin|flibanserin flexible dosing
16348528|NCT00277888|Procedure|Femoral route for hemodialysis|
16348529|NCT00277888|Procedure|Jugular route for hemodialysis|
16348530|NCT00277875|Drug|ALT-711 (alagebrium chloride)|
16348531|NCT00277862|Drug|Pegylated IFN- alpha 2b|
16348532|NCT00277862|Drug|Ribavirin|
16348533|NCT00277836|Drug|MST-997|
16348534|NCT00277823|Drug|DVS-SR 50 mg|
16348535|NCT00277823|Drug|DVS-SR 100 mg|
16348536|NCT00277823|Drug|Placebo|
16348537|NCT00277810|Drug|lecozotan SR (SRA-333)|one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr
16348538|NCT00277797|Device|Biowave Targeted Non-Invasive Electronic Pain Control Device|"This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms (Feed Signals) between two electrodes."
16348539|NCT00277797|Device|TENS (Transcutaneous Electrical Nerve Stimulation) device|This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.
16348540|NCT00277784|Procedure|Ultrasound examination|one ultrasound examination
16348541|NCT00277771|Behavioral|Standard behavioral treatment (SBT) for weight loss|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Standard paper diaries are used for self-monitoring.
16348601|NCT00277212|Drug|Lamotrigine + Aripiprazole|"Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
~Lamotrigine 100-200 mg/day
~Aripiprazole 10-30 mg/day"
16348542|NCT00277771|Behavioral|SBT for weight loss using a PDA|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants (PDAs) are used for self-monitoring.
16348543|NCT00277771|Behavioral|SBT for weight loss using a PDA with feedback messages|Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants with a customized feedback program are used for self-monitoring.
16348544|NCT00277758|Biological|Interleukin 2|Interleukin-2 at 1.2 mU/M2 administered subcutaneously daily
16348545|NCT00277758|Drug|Ribavirin|Ribavirin @ 800 mg daily (< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (> 85 kg)
16348546|NCT00277758|Biological|Pegylated Interferon Alpha|Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.
16348547|NCT00277758|Biological|Inteleukin-2|Interleukin-2 administered as a daily subcutaneous injection at 1.2 mU/M2 BSA
16348548|NCT00277758|Drug|Ribavirin + Pegylated interferon-alpha|Pegylated interferon-alpha administered 1.5 ug/kg weekly. Ribivirin 800 mg daily for body weight <65 kg, 1000 mg for body weight 65-85 kg, and 1200 mg for body weight >85 kg.
16348549|NCT00277745|Device|miniaturized microfluidic system|Subjects will provide appropriate periodontal treatment as needed.
16348550|NCT00277732|Procedure|Pharmaceutical care at baseline and follow-up visits over 6 months|
16348551|NCT00277706|Procedure|Periodontal surgery|
16348552|NCT00277706|Drug|FORTEO|parathyroid hormone; self-administration for 6 weeks
16348553|NCT00277706|Drug|Placebo|placebo; self administration for 6 weeks
16348554|NCT00277706|Dietary Supplement|Vitamin D and Calcium|PO, QD, for six weeks
16348555|NCT00277693|Drug|Spironolactone (drug)|
16348556|NCT00277680|Procedure|Laparoscopic bilateral occlusion of uterine artery|
16348557|NCT00277680|Procedure|Radiological embolization (UFE)|
16348558|NCT00277667|Drug|Quetiapine|Oral dosing: 50mg (Day 1), 100mg (Day 2), 150mg (Day 3), 200mg (Day 4), followed by flexible dosing from 50mg to 800mg through day 56.
16348559|NCT00277654|Drug|Risperidone|risperidone 0.5mg up to 4mg daily vs. placebo
16348560|NCT00277641|Drug|Lamotrigine|25 mg or 100 mg
16348561|NCT00277641|Drug|placebo|identical tablets to study drug
16348562|NCT00277602|Drug|Riluzole|
16348563|NCT00277589|Drug|Levothyroxin-Na|1 tablet 30 minutes before breakfast
16348564|NCT00277589|Drug|Levothyroxine-Na + iodide|1 tablet 30 minutes before breakfast
16348565|NCT00277589|Drug|Iodide|1 tablet 30 minutes before breakfast
16348566|NCT00277589|Drug|Placebo|1 tablet 30 minutes before breakfast
16348567|NCT00277576|Biological|ppdpSC18 administered by PMED|
16348568|NCT00277563|Device|reduction of pain scores by magnetic energy|
16348569|NCT00277550|Drug|Tegaserod and Placebo|
16348570|NCT00277537|Drug|Mannitol|320mg BD 12 weeks followed by 40 weeks open label
16348571|NCT00277537|Drug|placebo|BD for 12 weeks
16348572|NCT00277511|Drug|Levofloxacin|
16348573|NCT00277498|Drug|Xalacom|
16348574|NCT00277498|Drug|Xalatan|
16348575|NCT00277498|Drug|Timolol|
16348576|NCT00277472|Drug|Valsartan/Hydrochlorothiazide|160/12.5 mg taken once daily orally
16348577|NCT00277472|Drug|HCTZ|25 mg taken once daily orally
16348578|NCT00277446|Drug|Soy isoflavones|
16348579|NCT00277433|Other|Buccal Swab|collection of buccal swab
16348580|NCT00277420|Behavioral|Comprehensive weight management|
16348581|NCT00277407|Procedure|NAET with acupressure and/or chiropractic procedures|
16348582|NCT00277394|Drug|innohep®|175 anti-Xa IU/kg administered subcutaneously (SC) once daily
16348583|NCT00277394|Drug|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
16348584|NCT00277381|Behavioral|Automated feedback regarding drug adherence|
16348585|NCT00277368|Other|A structured questionnaire for seizure-related headache|A structured questionnaire for seizure-related headache
16348586|NCT00277355|Drug|minocycline|Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (~ 8 hours apart)
16348587|NCT00277355|Drug|Matching placebo|Matching placebo 1 capsule twice daily, 18 months treatment duration.
16348588|NCT00277342|Procedure|measurement of lipid-induced hepatic insulin resistance|
16348589|NCT00277329|Drug|XL999|• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.
16348590|NCT00277316|Drug|XL999|Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.
16348591|NCT00277303|Drug|XL999|XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.
16348592|NCT00277290|Drug|XL999|Treatment was administered on an outpatient basis. XL999 was administered at 2.4 mg/kg as a 4 hour intravenous (IV) infusion. Subjects received a XL999 infusion once a week for 8 weeks of treatment unless drug-related toxicity required a dosing delay
16348593|NCT00277277|Behavioral|Healthium|
16348594|NCT00277264|Drug|Tiotropium (Spiriva®)|
16348595|NCT00277251|Drug|Alendronate|
16348596|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
16348597|NCT00277238|Drug|CPG10101|CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
16348598|NCT00277238|Drug|Control|Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks
16348658|NCT00276757|Drug|methotrexate|
16348602|NCT00277212|Drug|Lamotrigine + Placebo|"Tablets, Oral, once daily, Phase 2 - up to 52 weeks
~Lamotrigine 100-200 mg/day
~placebo 0 mg/day"
16348603|NCT00277199|Drug|Abatacept|
16348604|NCT00277186|Other|New Care Continuum|Patient experience surgery through newly designed arthroplasty continuum
16348605|NCT00277173|Behavioral|Adoption of Crew Resource Management approach|
16348606|NCT00277160|Drug|Neulasta (pegfilgrastim)|Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
16348607|NCT00277147|Drug|BB IND 6989|
16348608|NCT00277108|Drug|Escitalopram (Lexapro)|
16348609|NCT00277095|Device|ProACT (Adjustable Continence Therapy)|Implantable device to reduce urinary stress incontinence
16348610|NCT00277082|Drug|9-NC in aerosol reservoir|Samples will be minced or centrifuged and L9NC extracted by chromatography. L9NC will be measured by HPLC or mass spectrometry
16348611|NCT00277069|Drug|Carboplatin|Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
16348612|NCT00277069|Device|Capecitabine|Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
16348613|NCT00277069|Drug|Vinorelbine|Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days
16348614|NCT00277043|Drug|paclitaxel, docetaxel, taxane|1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
16348615|NCT00277043|Drug|taxane|The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.
16348616|NCT00277030|Drug|Surfactant|
16348617|NCT00277030|Device|Nasal CPAP|
16348618|NCT00277017|Drug|5-Flourouracil, Interferon-a, IL-2 and Thalidomide|"Patients will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a max of 1200mg/day. This will be taken in combination with:5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
~Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks. Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
~Treatment will be followed by 2 weeks of rest then repeated."
16348619|NCT00276991|Drug|"Kallunk oxide (Immunotherapy) "|"The study was assigned only one Arm >450 cu/mm^3 of baseline CD + T cells. HIV type-1 subjects were received one drug, a daily regimen of Kallunk oxide(Immunotherapy) + Long Pepper, that is a combination of a traditional alternative medicine(Complementary and Alternative Medicine CAM) as Kallunk oxide and appropriate drug carrier antidote. The drug assigns to 0.100 mg and 0.200 mg Kallunk oxide molecules with 199.900 mg, and 499.800 mg Antidote( This antidote was used as a carrier of Kallunk oxide molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is Piper Longum."
16348620|NCT00276978|Drug|Aripiprazole|Addition of Aripiprazole 10 mg to concurrent medication
16348621|NCT00276965|Drug|Sertraline|Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
16348622|NCT00276965|Drug|Lithium carbonate|Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
16348623|NCT00276952|Drug|Gonyautoxin|
16348624|NCT00276939|Behavioral|Low-fat, low-Glycemic Index, vegan diet|
16348625|NCT00276926|Drug|STI571|
16348626|NCT00276913|Drug|STA-5312|
16348627|NCT00276900|Drug|Sertraline|
16348628|NCT00276887|Behavioral|Cognitive Behavior Therapy|
16348629|NCT00276887|Behavioral|Psychiatric Consultation Letter|
16348630|NCT00276874|Drug|Aripiprazole|Aripiprazole; 0-30 mg; oral; daily
16348631|NCT00276874|Drug|Placebos|Placebo; 0 mg; oral; daily
16348632|NCT00276861|Drug|gemcitabine hydrochloride|
16348633|NCT00276861|Drug|oxaliplatin|
16348634|NCT00276848|Drug|Fludarabine plus Cyclophosphamide|fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
16348635|NCT00276848|Drug|Fludarabine|fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
16348636|NCT00276835|Biological|High-dose interleukin-2|Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)
16348637|NCT00276835|Dietary Supplement|genistein|Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)
16348638|NCT00276822|Other|communication intervention|Patient Education Programs to include surveys, questionnaires, interviews, and videos.
16348639|NCT00276809|Biological|alemtuzumab|
16348640|NCT00276809|Biological|filgrastim|
16348641|NCT00276809|Drug|carmustine|
16348642|NCT00276809|Drug|cyclophosphamide|
16348643|NCT00276809|Drug|cytarabine|
16348644|NCT00276809|Drug|dexamethasone|
16348645|NCT00276809|Drug|etoposide|
16348646|NCT00276809|Drug|fludarabine phosphate|
16348647|NCT00276809|Drug|melphalan|
16348648|NCT00276809|Procedure|autologous bone marrow transplantation|
16348649|NCT00276809|Procedure|peripheral blood stem cell transplantation|
16348650|NCT00276809|Radiation|radiation therapy|
16348651|NCT00276796|Drug|cisplatin|
16348652|NCT00276796|Drug|paclitaxel|
16348653|NCT00276796|Drug|topotecan hydrochloride|
16348654|NCT00276783|Drug|pemetrexed|Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
16348655|NCT00276770|Other|fluorine F 18 fluorothymidine|
16348656|NCT00276770|Procedure|positron emission tomography|
16348657|NCT00276757|Drug|leucovorin calcium|
16348660|NCT00276757|Drug|vinblastine sulfate|
16348661|NCT00276744|Biological|cetuximab|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348662|NCT00276744|Drug|capecitabine|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348663|NCT00276744|Drug|docetaxel|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348664|NCT00276744|Drug|Erlotinib|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348665|NCT00276744|Drug|Gemcitabine|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348666|NCT00276744|Drug|Irinotecan|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348667|NCT00276744|Drug|mitomycin C|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348668|NCT00276744|Drug|rapamycin|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348669|NCT00276744|Procedure|conventional surgery|Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs.
16348670|NCT00276731|Drug|carboplatin|
16348671|NCT00276731|Drug|cisplatin|
16348672|NCT00276731|Drug|cyclophosphamide|
16348673|NCT00276731|Drug|etoposide|
16348674|NCT00276731|Drug|vincristine sulfate|
16348675|NCT00276731|Procedure|conventional surgery|
16348676|NCT00276731|Procedure|neoadjuvant therapy|
16348677|NCT00276731|Radiation|radiation therapy|
16348678|NCT00276718|Biological|bleomycin sulfate|
16348679|NCT00276718|Drug|carboplatin|
16348680|NCT00276718|Drug|etoposide|
16348681|NCT00276718|Procedure|conventional surgery|
16348682|NCT00276705|Drug|cisplatin|
16348683|NCT00276705|Drug|cyclophosphamide|
16348684|NCT00276705|Drug|doxorubicin hydrochloride|
16348685|NCT00276705|Drug|thalidomide|
16348686|NCT00276705|Procedure|adjuvant therapy|
16348687|NCT00276705|Procedure|conventional surgery|
16348688|NCT00276705|Procedure|neoadjuvant therapy|
16348689|NCT00276692|Drug|irinotecan hydrochloride|
16348690|NCT00276679|Drug|temozolomide|
16348691|NCT00276666|Drug|cisplatin|
16348692|NCT00276666|Drug|lomustine|
16348693|NCT00276666|Drug|vincristine sulfate|
16348694|NCT00276666|Procedure|adjuvant therapy|
16348695|NCT00276666|Radiation|radiation therapy|
16348696|NCT00276640|Drug|vincristine, carboplatin|"vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
~carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21"
16348697|NCT00276640|Drug|vincristine, carboplatin, etoposide|"vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21
~carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21
~etoposide: 100 mg/m² i.v., week 1,4,7,10"
16348698|NCT00276640|Radiation|radiation therapy|"intracranial tumor site: 30 fractions, dose per fraction: 1.8 Gy, total dose: 54 Gy, duration 6 weeks
~spinal tumor site: 28 fractions, dose per fraction: 1.8 Gy, total dose: 50.4 Gy duration 5 1/2 weeks"
16348699|NCT00276627|Behavioral|communication lecture|lecture on communication skills with oncology patients
16348700|NCT00276627|Behavioral|lecture plus CD-ROM|Interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.
16348701|NCT00276614|Drug|bortezomib|
16348702|NCT00276601|Drug|arsenic trioxide|
16348703|NCT00276601|Drug|cytarabine|
16348704|NCT00276601|Drug|daunorubicin hydrochloride|
16348705|NCT00276601|Drug|mercaptopurine|
16348706|NCT00276601|Drug|methotrexate|
16348707|NCT00276601|Drug|tretinoin|
16348708|NCT00276588|Drug|carboplatin|
16348709|NCT00276588|Drug|gemcitabine hydrochloride|
16348710|NCT00276588|Drug|paclitaxel|
16348711|NCT00276575|Biological|bevacizumab|
16348712|NCT00276575|Drug|erlotinib hydrochloride|
16348713|NCT00276575|Drug|everolimus|
16348714|NCT00276549|Drug|docetaxel|docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16348715|NCT00276549|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16348716|NCT00276536|Biological|recombinant interferon alpha-1b|interferon
16348717|NCT00276536|Drug|IFN|IFN daily
16348718|NCT00276523|Biological|PEG-interferon alfa-2b|Study medication begins on Day 1 and taken subcutaneously once each week with the last dose being taken within 1 week prior to surgery or biopsy.
16348823|NCT00275509|Drug|Cytogam|Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
16348719|NCT00276523|Procedure|Conventional surgery|Participants on the control arm may undergo surgery at anytime within 3 weeks of randomization, and those randomized to PEG-Intron will undergo surgery on Days 16-22 following initiation of treatment.
16348720|NCT00276523|Procedure|Neoadjuvant therapy|
16348721|NCT00276510|Drug|EGb 761® (Tanakan®)|120 mg, 1 tablet twice a day, oral route, during 5 years.
16348722|NCT00276510|Other|Placebo|1 tablet twice a day, oral route, during 5 years.
16348723|NCT00276497|Drug|Pioglitazone|
16348724|NCT00276484|Drug|atorvastatin|Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
16348725|NCT00276484|Drug|atorvastatin|Atorvastatin 40 mg by mouth, once a day for 6 weeks
16348726|NCT00276484|Drug|ezetimibe|Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
16348727|NCT00276471|Device|Implantable pulse generator and electrodes|
16348728|NCT00276458|Drug|Comparator: atorvastatin|Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
16348729|NCT00276458|Drug|Comparator: Placebo|Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
16348730|NCT00276458|Drug|Comparator: ezetimibe|Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
16348731|NCT00276458|Drug|Comparator: Placebo.|Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
16348732|NCT00276445|Drug|beta-1,3-glucan|
16348733|NCT00276432|Device|iSTAT point of care analyzer|
16348734|NCT00276419|Drug|Diclofenac|Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
16348735|NCT00276419|Drug|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
16348736|NCT00276406|Drug|Pyridostigmine|Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
16348737|NCT00276406|Drug|Placebo|If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.
16348738|NCT00276393|Drug|Basal insulin|
16348739|NCT00276380|Drug|EGb761|EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
16348740|NCT00276380|Drug|Placebo|Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
16348741|NCT00276380|Drug|Acetylsalicylic acid|Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
16348742|NCT00276354|Drug|PEG 4000 (Forlax ®)|
16348743|NCT00276341|Drug|EGb 761® (Tanakan®)|
16348744|NCT00276328|Drug|Diosmectite (Smecta®)|
16348745|NCT00276315|Biological|Botulinum toxin type A|
16348746|NCT00276302|Drug|IPI-504|"IV administration of IPI-504 for 21-day cycles. Two different schedules of treatment will be tested. On Schedule A, doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration. On Schedule B, doses occur on Days 1, 4, 8, 11, 15, and 18, or twice weekly for 3 weeks continuously.
~For both Schedule A and B doses will be administered ≥ 72 hours apart."
16348747|NCT00276289|Drug|Spironolactone|
16348748|NCT00276276|Drug|topotecan|
16348749|NCT00276263|Drug|Sarcosine (N-methylglycine)|Randomization to two treatment groups. One group treated with sarcosine 2 g/day for 16 weeks, the other group treated with placebo 2 g/day for 16 weeks.
16348750|NCT00276250|Drug|Efalizumab|Efalizumab was a medication approved for use in psoriasis which was being explored to determine efficacy with immunosuppression following organ transplantation. Efalizumab was administered subcutaneously on a weekly basis. Upon efalizumab being withdrawn from the US market, the protocol was amended to alter the immunosuppressive regimen to abatacept for the study participants.
16348751|NCT00276250|Drug|Abatacept|Abatacept is drug used to treat autoimmune diseases. Abatacept is administered intravenously, monthly, in weight-based doses and is given for as long as transplanted islets are functioning.
16348752|NCT00276250|Drug|Belatacept|Belatacept is a medication to provide extended graft survival while limiting the toxicity generated by standard immune suppressing regimens. Belatacept is administered intravenously. The protocol for this study was amended to substitute belatacept for abatacept for all newly enrolling participants (current participants remained on abatacept).
16348753|NCT00276224|Drug|ferrous sulphate (drug)|
16348754|NCT00276198|Dietary Supplement|Sprinkles|Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
16348755|NCT00276198|Dietary Supplement|Ferripel-3, Vitamins A&D drops|Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
16348756|NCT00276185|Drug|Time delay treatment of botulinum toxin|
16348757|NCT00276172|Drug|Natalizumab|Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
16348758|NCT00276159|Drug|852A|Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
16348759|NCT00276146|Drug|oral dipyridamole, oral magnesium, or a combination of both|
16348760|NCT00276133|Drug|Effects of atorvastatin versus probucol on small dense LDL|
16348761|NCT00276107|Biological|Prevenar|
16348762|NCT00276094|Drug|Ospemifene 30 mg|1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
16348763|NCT00276094|Drug|Ospemifene 60 mg|1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
16348764|NCT00276094|Drug|Placebo|1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
16348765|NCT00276094|Drug|Nonhormonal vaginal lubricant|Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
16348766|NCT00276081|Drug|Gabapentin, Estrogen and placebo administration|
16348767|NCT00276068|Drug|topical lidocaine + oral desipramine, and/or placebo|
16348818|NCT00275509|Other|Plasmapheresis|Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
16348819|NCT00275509|Drug|Mycophenolate mofetil|2 gm/day. Standard of care
16348820|NCT00275509|Drug|Tacrolimus|To achieve serum level of 8-10 ng/ml.
16348821|NCT00275509|Drug|Dexamethasone|100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
16348822|NCT00275509|Drug|Prednisone|Taper over three months to 5 mg daily
16348768|NCT00276055|Drug|Gemcitabine, Docetaxel and Bevacizumab|During the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
16348769|NCT00276042|Drug|Faropenem Medoxomil|
16348770|NCT00276029|Drug|Etanercept|
16348771|NCT00276016|Drug|phenylephrine|immediate-release 12 mg capsules for oral administration
16348772|NCT00276016|Drug|pseudoephedrine|60 mg immediate-release tablets for oral administration
16348773|NCT00276016|Drug|placebo|placebo capsules
16348774|NCT00276003|Drug|Gemcitabine, Irinotecan, Allopurinol.|Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle
16348775|NCT00275990|Device|rheolytic thrombectomy with direct stenting|
16348776|NCT00275990|Device|direct stenting|
16348777|NCT00275977|Procedure|Coronary catherization and stem cell infusion|
16348778|NCT00275964|Drug|TMN-1|
16348779|NCT00275951|Drug|Cetuximab Plus P-HDFL|Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
16348780|NCT00275938|Drug|interferon alpha 2b plus ribavirin|
16348781|NCT00275938|Drug|interferon alpha 2b plus placebo|
16348782|NCT00275925|Drug|Oxcarbazepine|
16348783|NCT00275912|Drug|Oxcarbazepine|
16348784|NCT00275834|Drug|Zonisamide|zonisamide 400 mg, 200 mg, or placebo
16348785|NCT00275821|Drug|Ranibizumab 0.3 mg - 3 times monthly, then quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
16348786|NCT00275821|Drug|Ranibizumab 0.5 mg - 3 times monthly, then quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
16348787|NCT00275821|Drug|Ranibizumab 0.3 mg monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
16348788|NCT00275795|Procedure|NAET Procedures|
16348789|NCT00275769|Device|Pacemaker|
16348790|NCT00275756|Drug|Timolol (drug)|Timolol (0.5%, non-selective beta-blocker, Timoptic®, Merck Sharp & Dohme, Haarlem, Netherlands), dose 1 drop in one eye twice daily for two weeks
16348791|NCT00275756|Drug|dorzolamide (drug)|Dorzolamide (2%, carbonic anhydrase inhibitor, Trusopt®, Laboratoires Merck Sharp & Dohme - Chibret, France), dose: 1 drop in one eye twice daily for two weeks
16348792|NCT00275756|Drug|brimonidine (drug)|Brimonidine (0.2%. alpha-2 adrenergic agonist, Alphagan®, Allergan Pharmaceuticals, Westport, Ireland), dose: 1 drop in one eye twice daily for two weeks
16348793|NCT00275756|Device|Laser Doppler flowmetry|blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
16348794|NCT00275756|Device|Goldmann applanation tonometer|intraocular pressure measurements, in total 2x 5 measurements on two study days
16348795|NCT00275756|Procedure|Suction cup method|The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
16348796|NCT00275743|Procedure|MRI|
16348797|NCT00275730|Drug|indometacine (drug) effect on ocular blood flow|
16348798|NCT00275704|Drug|Flaxseed|
16348799|NCT00275678|Procedure|Blood stem cell versus bone marrow transplant|"Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.
~Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.
~Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.
~Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels."
16348800|NCT00275665|Drug|Valganciclovir|
16348801|NCT00275652|Drug|LdT (Telbivudine) and lamivudine|
16348802|NCT00275639|Drug|Cozaar|
16348803|NCT00275613|Drug|Rituximab|The Rituximab dose is 1000 mg (1 gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)
16348804|NCT00275600|Drug|Vitamin E, Evening Oil of Primrose, and Placebo|
16348805|NCT00275574|Procedure|acupuncture|acupuncture
16348806|NCT00275561|Drug|Fluticasone|Aerosolized swallowed fluticasone 880 mg twice a day
16348807|NCT00275561|Drug|Placebo|Placebo inhaler swallowed twice a day for 6 weeks
16348808|NCT00275548|Drug|Pegasys|135-180 micrograms administered sc once weekly
16348809|NCT00275548|Drug|Copegus|400-1200 mg/day for 48 weeks
16348810|NCT00275535|Drug|Anti-thymocyte globulin|Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
16348811|NCT00275535|Drug|Mycophenolate mofetil|Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
16348812|NCT00275535|Drug|Prednisone|Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
16348813|NCT00275535|Drug|Tacrolimus|Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
16348814|NCT00275535|Drug|Sirolimus|Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
16348824|NCT00275496|Procedure|Sentinel Lymph Node Dissection|Subject has wide excision and sentinel lymph node dissection for primary melanoma.
16348825|NCT00275496|Procedure|Complete Lymph Node Dissection|Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma.
16348826|NCT00275496|Procedure|Wide Excision|Subject has wide excision only for primary melanoma.
16348827|NCT00275483|Device|Vital-band (R)|
16348828|NCT00275457|Drug|pramipexole|
16348829|NCT00275444|Drug|Tipranavir|
16348830|NCT00275431|Drug|AT-101|Oral
16348831|NCT00275418|Drug|beta carotene from Dunaliella algae|
16348832|NCT00275405|Drug|Garlic Oil Macerate|
16348833|NCT00275392|Behavioral|Vestibular rehabilitation|vestibular adaptation and substitution exercises
16348834|NCT00275392|Behavioral|Placebo|placebo vestibular exercises
16348835|NCT00275379|Drug|ERB-041|
16348836|NCT00275366|Device|Robotic Therapy|
16348837|NCT00275353|Behavioral|Individualized Symptom Education|
16348838|NCT00275340|Other|Peer Support|
16348839|NCT00275314|Drug|Valganciclovir|
16348840|NCT00275301|Drug|olanzapine|Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.
16348841|NCT00275275|Drug|Requip PR|Requip 24-Hour once a day for one month
16348842|NCT00275275|Drug|Mirapex|All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.
16348843|NCT00275262|Drug|Leuprolide acetate depot (LAD) 11.25 mg 3 Month|LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.
16348844|NCT00275262|Drug|Matched placebo|Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.
16348845|NCT00275249|Drug|levorphanol|
16348846|NCT00275236|Drug|Rotigotine|
16348847|NCT00275210|Drug|Oxaliplatin (SR96669)|
16348848|NCT00275197|Drug|Sertraline and Elzasonan Combination|
16348849|NCT00275197|Drug|Sertraline|
16348850|NCT00275197|Drug|Placebo|
16348851|NCT00275184|Drug|Senna|
16348852|NCT00275184|Drug|Citramag powder|
16348853|NCT00275184|Drug|Metoclopramide|
16348854|NCT00275171|Drug|Recombinant human thyrotropin (Thyrogen)|0.1 mg rhTSH administered intramuscularly
16348855|NCT00275171|Drug|recombinant human TSH|0.1 mg rhTSH administered intramuscularly
16348856|NCT00275171|Other|isotonic saline = placebo|0.1 mg isotonic saline injected intramuscularly
16348857|NCT00275158|Drug|L-Arginine Supplementation|
16348858|NCT00275145|Behavioral|Resistance Training|Lifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets
16348859|NCT00275145|Behavioral|Aerobic Exercise|Exercise at 75% of maximal capacity for approximately 2 hours per week
16348860|NCT00275145|Behavioral|Combo|Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group
16348861|NCT00275145|Behavioral|Continued Sedentary lifestyle|No changes
16348862|NCT00275132|Drug|erlotinib hydrochloride|Tarceva (OSI-774, erlotinib) PO 150 mg daily
16348863|NCT00275132|Drug|Matched placebo|Matched placebo PO daily
16348864|NCT00275119|Drug|fluorouracil|
16348865|NCT00275119|Drug|gemcitabine hydrochloride|
16348866|NCT00275119|Drug|oxaliplatin|
16348867|NCT00275119|Radiation|radiation therapy|
16348868|NCT00275106|Drug|asparaginase|
16348869|NCT00275106|Drug|cyclophosphamide|
16348870|NCT00275106|Drug|cytarabine|
16348871|NCT00275106|Drug|daunorubicin hydrochloride|
16348872|NCT00275106|Drug|dexamethasone|
16348873|NCT00275106|Drug|doxorubicin hydrochloride|
16348874|NCT00275106|Drug|leucovorin calcium|
16348875|NCT00275106|Drug|mercaptopurine|
16348876|NCT00275106|Drug|methotrexate|
16348877|NCT00275106|Drug|prednisolone|
16348878|NCT00275106|Drug|thioguanine|
16348879|NCT00275106|Drug|vincristine sulfate|
16348880|NCT00275106|Procedure|radiation therapy|
16348881|NCT00275093|Drug|temsirolimus|Given IV
16348882|NCT00275093|Other|laboratory biomarker analysis|Correlative studies
16348883|NCT00275093|Other|pharmacological study|Correlative studies
16348884|NCT00275080|Drug|vorinostat|Given orally
16348885|NCT00275080|Drug|decitabine|Given IV
16348886|NCT00275067|Drug|arsenic trioxide|Arsenic trioxide administered intravenously at a dose of 0.20mg/kg Daily x 5 week then twice per week
16348887|NCT00275067|Drug|temozolomide|Temozolomide administered orally once per day 1 hour prior to radiation therapy at a dose of 75 mg/m2 x 42 days; at a dose of 200mg/m2 for 5 days every cycle (1 cycle = 28 days) after radiation therapy
16348888|NCT00275067|Radiation|radiation therapy|All patients will receive 5940-6120 cGy of radiation therapy as 28-33 treatments/fractions (180-200 cGy/treatment) depending on whether they receive standard 3-D conformal radiation therapy or intensity modulated radiation therapy.
16348889|NCT00275054|Drug|Fludarabine|cycles 1-6: 25 mg/m² i.v., d2-4, q28d
16348890|NCT00275054|Drug|Cyclophosphamide|cycles 1-6: 250 mg/m² i.v., d2-4, q28d
16348891|NCT00275054|Biological|Rituximab|"cycle1: 375 mg/m² i.v., d1, q28d
~cycles 2-6: 500 mg/m² i.v., d1, q28d"
16348892|NCT00275041|Biological|cetuximab|
16348893|NCT00275041|Drug|irinotecan hydrochloride|
16348894|NCT00275028|Drug|cediranib maleate|Given orally
16348895|NCT00275015|Biological|filgrastim|
16348896|NCT00275015|Drug|carmustine|
16348897|NCT00275015|Drug|cyclophosphamide|
16348898|NCT00275015|Drug|cytarabine|
16348899|NCT00275015|Drug|dexamethasone|
16348900|NCT00275015|Drug|etoposide|
16348901|NCT00275015|Drug|fludarabine phosphate|
16348902|NCT00275015|Drug|melphalan|
16348903|NCT00275015|Procedure|bone marrow ablation with stem cell support|
16348904|NCT00275015|Procedure|peripheral blood stem cell transplantation|
16348905|NCT00275015|Radiation|radiation therapy|
16348906|NCT00275002|Drug|O6-benzylguanine|Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. O6-Benzylguanine, 120 mg/m^2, will be administered as a one-hour intravenous (IV) infusion, daily for 5 days. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses of therapy.
16348907|NCT00275002|Drug|temozolomide|Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Temozolomide, 75 mg/m^2 (rounded to the nearest 5 mg, the size of the smallest capsule) will be given orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses.
16348908|NCT00274989|Drug|Bendamustine|"First-Line Therapy: Bendamustine i.v. 90 mg/m² day 1-2, q4wks, cycle 1 to 6
~2nd to 4th -Line Therapy: Bendamustine i.v. 70 mg/m² day 1-2 q4wks, cycle 1 to 6"
16348909|NCT00274989|Biological|Rituximab|"First-Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6
~2nd to 4th -Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6"
16348910|NCT00274976|Biological|alemtuzumab|
16348911|NCT00274963|Drug|bendamustine hydrochloride|
16348912|NCT00274963|Drug|mitoxantrone hydrochloride|
16348913|NCT00274950|Biological|bleomycin sulfate|
16348914|NCT00274950|Drug|carboplatin|
16348915|NCT00274950|Drug|cisplatin|
16348916|NCT00274950|Drug|etoposide|
16348917|NCT00274950|Drug|ifosfamide|
16348918|NCT00274950|Drug|vinblastine sulfate|
16348919|NCT00274950|Procedure|adjuvant therapy|
16348920|NCT00274950|Procedure|conventional surgery|
16348921|NCT00274937|Drug|amifostine trihydrate|Given subcutaneously
16348922|NCT00274937|Drug|fluorouracil|Given IV
16348923|NCT00274937|Drug|cisplatin|Given IV
16348924|NCT00274937|Other|laboratory biomarker analysis|Correlative studies
16348925|NCT00274937|Radiation|radiation therapy|Undergo radiotherapy
16348926|NCT00274924|Biological|filgrastim|Given subcutaneously or intravenous bolus.
16348927|NCT00274924|Biological|rituximab|Given IV
16348928|NCT00274924|Drug|carboplatin|Given IV
16348929|NCT00274924|Drug|cyclophosphamide|Given IV
16348930|NCT00274924|Drug|doxorubicin hydrochloride|Given IV
16348931|NCT00274924|Drug|etoposide|Given IV
16348932|NCT00274924|Drug|ifosfamide|Given IV
16348933|NCT00274924|Drug|prednisone|Taken orally
16348934|NCT00274924|Drug|vincristine|Given IV
16348935|NCT00274911|Drug|cisplatin|
16348936|NCT00274911|Drug|lomustine|
16348937|NCT00274911|Drug|vincristine sulfate|
16348938|NCT00274911|Procedure|adjuvant therapy|
16348939|NCT00274911|Radiation|radiation therapy|
16348940|NCT00274898|Drug|celecoxib|
16348941|NCT00274898|Drug|docetaxel|
16348942|NCT00274898|Procedure|adjuvant therapy|
16348943|NCT00274898|Radiation|radiation therapy|
16348944|NCT00274885|Drug|oxaliplatin|
16348945|NCT00274885|Procedure|management of therapy complications|
16348946|NCT00274872|Drug|fluorouracil|
16348947|NCT00274872|Drug|leucovorin calcium|
16348948|NCT00274872|Drug|oxaliplatin|
16348949|NCT00274859|Drug|gemcitabine hydrochloride|
16348950|NCT00274859|Drug|oxaliplatin|
16348951|NCT00274846|Biological|aldesleukin|10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses
16348952|NCT00274846|Biological|therapeutic allogeneic lymphocytes|Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9
16348953|NCT00274846|Drug|cyclophosphamide|Days -5 and -4: 60 mg/kg
16348954|NCT00274846|Drug|fludarabine phosphate|Days -5 through -2: 25 mg/m^2
16348955|NCT00274846|Procedure|in vitro treated peripheral blood stem cell transplantation|Day 0 infuse natural killer cells
16348956|NCT00274833|Drug|erlotinib hydrochloride|Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.
16348957|NCT00274833|Drug|temozolomide|TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.
16348958|NCT00274833|Radiation|radiation therapy|Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.
16348959|NCT00274820|Dietary Supplement|ascorbic acid|The dose of ascorbic acid will be 1000 mg PO 2-3 hours prior to ATO infusion. The treatment will follow the same schedule as arsenic trioxide.
16348960|NCT00274820|Drug|arsenic trioxide|Treatment consists of a loading period of five 0.25 mg/kg ATO doses in the first week, followed by maintenance dosing with 0.25 mg/kg ATO twice weekly for 11 weeks. Loading is usually done Monday through Friday of the first treatment week. Maintenance should be started either 72 or 96 hours after the last loading dose. Thereafter, dosing is twice weekly, following an alternating pattern of 72 and 96 hours. For example, maintenance dosing may be done on Mondays and Thursdays, Tuesdays and Fridays, etc. The same pattern should be followed for the entire maintenance dosing period.
16348961|NCT00274820|Drug|dexamethasone|Dexamethasone will be given at a dose of 4mg PO daily for five days every four weeks (i.e., days 1-5, 29-33, 57-61, 84-88, etc.).
16348962|NCT00274820|Drug|thalidomide|The dose of thalidomide will be 50 mg PO daily starting day 1. The dose will be increased to 100mg PO daily after two weeks if tolerated and only if patients experience < grade 1 thalidomide-attributed toxicity using CTC criteria.
16348963|NCT00274807|Biological|filgrastim|
16348964|NCT00274807|Drug|cytarabine|
16348965|NCT00274807|Drug|etoposide|
16348966|NCT00274807|Drug|mitoxantrone hydrochloride|
16348967|NCT00274794|Biological|filgrastim|10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide
16348968|NCT00274794|Biological|rituximab|375 mg/m2, IV, Once per week for 3 weeks.
16348969|NCT00274781|Drug|arsenic trioxide|Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).
16348970|NCT00274781|Drug|gemtuzumab ozogamicin|Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion
16348971|NCT00274768|Drug|capecitabine|A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).
16348972|NCT00274755|Drug|chemotherapy|
16348973|NCT00274755|Procedure|conventional surgery|
16348974|NCT00274755|Procedure|magnetic resonance imaging|
16348975|NCT00274755|Procedure|magnetic resonance spectroscopic imaging|
16348976|NCT00274755|Radiation|radiation therapy|
16348977|NCT00274742|Biological|Blinatumomab (MT103)|Doses from 0.5 to 120 µg/m^2/24hours by continuous intravenous infusion
16348978|NCT00274729|Behavioral|Mono Unsaturated Fatty Acids in Obesity|
16348979|NCT00274716|Drug|MK0736|
16348980|NCT00274716|Drug|MK0916|
16348981|NCT00274716|Drug|Placebo|
16348982|NCT00274703|Drug|mepolizumab|
16348983|NCT00274690|Drug|GW679769|
16348984|NCT00274677|Drug|Placebo|Experimental treatment arm
16348985|NCT00274677|Drug|lamotrigine|Experimental treatment
16348986|NCT00274664|Device|6 hours occlusion by patching|
16348987|NCT00274664|Device|12 hours occlusion by patching|
16348988|NCT00274651|Drug|belinostat|
16348989|NCT00274638|Drug|Telmisartan & Hydrochlorothiazide|
16348990|NCT00274638|Drug|Losartan & Hydrochlorothiazide|
16348991|NCT00274638|Procedure|ABPM|
16348992|NCT00274625|Device|Surgisis Gold Graft|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
16348993|NCT00274625|Procedure|Control|Incision is closed without the placement of a graft material (standard of care control)
16348994|NCT00274612|Drug|Telmisartan|
16348995|NCT00274612|Drug|Ramipril|
16348996|NCT00274599|Drug|Telmisartan|
16348997|NCT00274599|Drug|Ramipril|
16348998|NCT00274586|Drug|Aggrenox® modified release capsules|
16348999|NCT00274586|Drug|Aggrenox® modified release capsules matching placebo|
16349000|NCT00274573|Drug|Tiotropium bromide|
16349001|NCT00274560|Drug|Tiotropium|
16349002|NCT00274560|Drug|Salmeterol|
16349003|NCT00274547|Drug|Tiotropium|
16349004|NCT00274534|Drug|Tiotropium|
16349005|NCT00274534|Drug|Salmeterol|
16349006|NCT00274521|Drug|Tiotropium|
16349007|NCT00274508|Drug|tiotropium bromide|
16349008|NCT00274495|Drug|Rosiglitazone and Pegasys/Ribavirin|
16349009|NCT00274469|Drug|fulvestrant|500 mg intramuscular injection
16349010|NCT00274469|Drug|anastrozole|1 mg oral tablet
16349011|NCT00274456|Drug|ABI-007|ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.
16349012|NCT00274456|Drug|Docetaxel|Docetaxel dosed q3w at 100 mg/m^2
16349013|NCT00274443|Drug|ABI-007 (Abraxane) and Carboplatin|ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
16349014|NCT00274430|Drug|dexamethasone 8 mg bid|
16349015|NCT00274430|Drug|tadalafil 10mg bid|
16349016|NCT00274417|Drug|dutasteride|
16349017|NCT00274404|Drug|valacyclovir|
16349018|NCT00274391|Drug|7% NaCl|
16349019|NCT00274391|Drug|Amiloride HCl|
16349020|NCT00274378|Device|ALLOMATRIX injectable putty in distal radius fractures|
16349021|NCT00274365|Procedure|videoconference|
16349022|NCT00274352|Drug|adalimumab|Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.
16349023|NCT00274339|Drug|Prevacid 30mg BID|
16349024|NCT00274339|Behavioral|Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods.|
16349025|NCT00274326|Drug|SR121463B|
16349026|NCT00274313|Drug|552-02|
16349027|NCT00274300|Biological|pPJV7630 administered by PMED|
16349028|NCT00274287|Drug|GM CSF|250 ug/m2 daily for 2 weeks followed by 2 weeks of rest
16349029|NCT00274274|Drug|insulin detemir|
16349030|NCT00274274|Drug|insulin aspart|
16349031|NCT00274261|Drug|C31G|The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
16349032|NCT00274261|Drug|nonoxynol-9 (N-9)|The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.
16349033|NCT00274248|Drug|MLN518|
16349034|NCT00274235|Drug|sulfadoxine-pyrimethamine / mefloquine|
16349035|NCT00274209|Procedure|Chromoendoscopy with magnification|A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.
16349036|NCT00274196|Procedure|ultrasound examination|a single time 10 minutes procedure within the first week after the injury
16349037|NCT00274196|Procedure|MRI scan|a single time 30 minutes procedure, performed always after the ultrasound scan
16349038|NCT00274170|Drug|Octreotide|
16349039|NCT00274157|Behavioral|Behavior|
16349040|NCT00274157|Behavioral|diet control, smoking cessation, exercize|
16349041|NCT00274144|Drug|telmisartan 40 mg|
16349042|NCT00274144|Drug|placebo 40 mg|
16349043|NCT00274131|Drug|Pramipexole 0.125 mg tablets|
16349044|NCT00274131|Drug|Pramipexole 0.5 mg tablets|
16349045|NCT00274118|Drug|telmisartan|
16349049|NCT00274092|Drug|tiotropium inhalation capsules (18 mcg once daily)|
16349050|NCT00274092|Drug|Atrovent MDI (2 puffs of 20 mcg(q.i.d.) in patients|
16349051|NCT00274079|Drug|SPIRIVA|
16349052|NCT00274066|Drug|Tiotropium + placebo|
16349053|NCT00274066|Drug|Tiotropium + ipratropium|
16349054|NCT00274066|Drug|Tiotropium + fenoterol|
16349055|NCT00274053|Drug|tiotropium|
16349056|NCT00274040|Drug|Tiotropium|
16349057|NCT00274040|Drug|Ipratropium|
16349058|NCT00274027|Drug|tiotropium bromide|
16349059|NCT00274014|Drug|Tiotropium|
16349060|NCT00274001|Drug|Nevirapine|
16349061|NCT00273988|Drug|nevirapine|
16349062|NCT00273975|Drug|Nevirapine|
16349063|NCT00273975|Drug|Lamivudine|
16349064|NCT00273975|Drug|Zidovudine|
16349065|NCT00273962|Drug|ipratropium plus salbutamol UDV|
16349066|NCT00273962|Drug|salbutamol UDV|
16349067|NCT00273949|Drug|lactulose|
16349068|NCT00273936|Drug|AVN-944 capsules for oral administration|
16349069|NCT00273910|Drug|gp100:209-217 (210M)|
16349070|NCT00273910|Drug|Montanide ISA-51|
16349071|NCT00273910|Drug|Imiquimod|Apply imiquimod 5% cream to the skin at the site of injection daily for 5 days
16349072|NCT00273897|Device|Phoresor II|
16349073|NCT00273884|Drug|Amonafide L-Malate|
16349074|NCT00273884|Drug|Cytarabine|
16349075|NCT00273871|Drug|Cyclosporin or tacrolimus|
16349076|NCT00273858|Other|There is no Intervention. The study is observational.|The study is observational and the prescription follows the SmPC of etanercept.
16349077|NCT00273845|Behavioral|Motivational interviewing|One session
16349078|NCT00273845|Behavioral|Strengths-Based Case Management|5 sessions
16349079|NCT00273832|Procedure|coronary artery computed tomography angiogram|
16349080|NCT00273832|Procedure|single photon emission computed tomography|
16349081|NCT00273819|Procedure|CT angiography|
16349082|NCT00273806|Behavioral|Intervention for 4 behavioral risks by medical assistants.|
16349083|NCT00273793|Behavioral|Contingency Management|incentives are available for reduced smoking on each study visit which occur each weekday.
16349084|NCT00273780|Behavioral|Adherence counseling|Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.
16349085|NCT00273780|Device|Alarm device|This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
16349086|NCT00273767|Drug|epoetin beta|800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery
16349087|NCT00273767|Drug|placebo|60ml of NaCl IV slow
16349088|NCT00273754|Drug|Caffeine|Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
16349089|NCT00273754|Drug|Placebo|Children in group two will receive an amount of normal saline equal to Caffeine
16349090|NCT00273741|Drug|methylphenidate|methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days
16349091|NCT00273741|Drug|placebo comparator|placebo capsules
16349092|NCT00273728|Drug|hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline|hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline
16349093|NCT00273715|Procedure|Surgical wound closure techniques|Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
16349094|NCT00273715|Procedure|Surgical wound closure techniques (Comparator)|Subjects will be randomized to either receive sutures or staples during the surical procedure to close the incision
16349095|NCT00273702|Drug|N-Acetyl Cysteine|
16349096|NCT00273689|Drug|montelukast vs pretreatment with albuterol|montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
16349097|NCT00273689|Drug|montelukast|Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
16349098|NCT00273676|Procedure|Conversion to oral antibiotic treatment after 3 days of intravenous antibiotic treatment|
16349099|NCT00273663|Device|TCES|
16349100|NCT00273650|Drug|methylcobalamin|Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
16349101|NCT00273650|Other|saline placebo|Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
16349102|NCT00273624|Drug|Olanzapine|10 mg Olanzapin concurrent to antidepressive medication
16349103|NCT00273624|Drug|Placebo|placebo
16349104|NCT00273611|Behavioral|Pharmacist Education about Vitamin D|
16349105|NCT00273598|Procedure|Moss Miami Spine Instrumentation System|
16349106|NCT00273598|Procedure|Universal Spine Instrumentation System|
16349107|NCT00273585|Device|Personally-tailored educational software program|
16349108|NCT00273572|Other|Moderate Lifestyle Intervention|Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
16349109|NCT00273572|Other|Intensive lifestyle intervention|A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
16349110|NCT00273559|Drug|prednisone|group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
16349111|NCT00273546|Drug|XRP6976 (Docetaxel/Taxotere)|
16349112|NCT00273533|Drug|Ramipril|
16349113|NCT00273520|Drug|Telithromycin|
16349114|NCT00273507|Drug|Carboplatin and Paclitaxel|
16349115|NCT00273494|Procedure|Surgery|
16349116|NCT00273481|Drug|dorzolamide 2%/timolol maleate 0.5% fixed combination|
16349117|NCT00273481|Drug|latanoprost 0.005%/timolol maleate 0.5% fixed combination|
16349118|NCT00273481|Drug|timolol maleate 0.5%|
16349119|NCT00273481|Drug|placebo|
16349120|NCT00273468|Drug|Granisetron|
16349121|NCT00273455|Drug|bimatoprost 0.03%|
16349122|NCT00273455|Drug|dorzolamide 2%/timolol maleate 0.5% fixed combination|
16349123|NCT00273455|Drug|placebo|
16349124|NCT00273442|Drug|timolol maleate|
16349125|NCT00273442|Drug|dorzolamide/timolol maleate fixed combination|
16349126|NCT00273429|Drug|timolol maleate 0.5%|
16349127|NCT00273429|Drug|dorzolamide/timolol maleate fixed combination|
16349128|NCT00273429|Drug|latanoprost 0.005%|
16349129|NCT00273429|Drug|placebo|
16349130|NCT00273416|Drug|PF-00592379|
16349131|NCT00273416|Drug|Sildenafil 100mg|
16349132|NCT00273403|Behavioral|Maintenance in Care Services|
16349133|NCT00273403|Behavioral|Access to Care Services|
16349134|NCT00273390|Drug|Remicade (infliximab)|
16349135|NCT00273377|Other|Mild intraoperative hypercapnia (50 mmHg vs. 30 mmHg)|
16349136|NCT00273377|Other|Supplemental oxygen (80% vs. 30%)|
16349137|NCT00273377|Drug|Dexamethasone|4 mg
16349138|NCT00273377|Drug|Placebo|placebo
16349139|NCT00273364|Procedure|Hematopoietic Stem Cell Therapy|After mobilization and harvest of stem cells, stem cells will be infused following conditioning regimen
16349140|NCT00273364|Drug|Standard treatment with a conventional drug|Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Tysabri (natalizumab), or Gilenya (fingolimod)
16349141|NCT00273351|Drug|[123I]B-CIT|Subjects will receive up to 6 mCi of [123I] B-CIT injected intravenously
16349142|NCT00273338|Drug|calcitriol|
16349143|NCT00273338|Drug|docetaxel|
16349144|NCT00273312|Drug|Patupilone|Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials
16349145|NCT00273299|Drug|valsartan plus hydrochlorothiazide|
16349146|NCT00273286|Behavioral|family diabetes management intervention|a clinic-integrated, low intensity, multi-component behavioral intervention
16349147|NCT00273273|Procedure|blood draw|
16349148|NCT00273260|Behavioral|individualised bone density feedback and education|
16349149|NCT00273247|Drug|Interferon alpha-2b|
16349150|NCT00273234|Procedure|Autologous Platelet Gel (APG)|
16349151|NCT00273221|Procedure|Glaucoma Implant Surgery|
16349152|NCT00273221|Procedure|trabeculectomy|
16349153|NCT00273221|Procedure|phacoemulsification|
16349154|NCT00273208|Behavioral|10 week behavioral intervention program|
16349155|NCT00273195|Device|Implantable Cardioverter Defibrillator|
16349156|NCT00273182|Device|InSync Model 8040|Subjects with sucessful implants of InSync Model 8040.
16349157|NCT00273182|Device|InSync III Model 8042|Subjects with successful implants of InSync III Model 8042
16349158|NCT00273156|Behavioral|Telephone quitline|
16349159|NCT00273130|Procedure|transnasal endoscopy|
16349160|NCT00273130|Procedure|transoral thin endoscopy|
16349161|NCT00273117|Procedure|transnasal gastroscopy|
16349162|NCT00273104|Procedure|Bariatric surgery|Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
16349163|NCT00273104|Behavioral|Intensive lifestyle intervention|Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
16349164|NCT00273091|Device|ICD with CRT therapy|permanently CRT pacing
16349165|NCT00273065|Drug|Neosaxitoxin|
16349166|NCT00273052|Drug|Carvedilol Phosphate modified release formulation|
16349167|NCT00273052|Drug|metoprolol succinate|
16349168|NCT00273039|Drug|paroxetine|
16349169|NCT00273026|Drug|salmeterol xinafoate/fluticasone propionate|
16349170|NCT00273013|Drug|GW274150|GW274150 will be available as 30 mg white oval tablets.
16349171|NCT00273013|Drug|Singulair|Singulair will be available as over encapsulated 10 mg orange tablets.
16349172|NCT00273013|Drug|Placebo|Matching placebo for Singulair and GW274150 will be available.
16349173|NCT00273000|Drug|GLP-2|
16349174|NCT00272987|Drug|lapatinib|(GW572016) 1000 mg QD
16349175|NCT00272987|Drug|paclitaxel|80 mg/m2 IV weekly for three weeks
16349176|NCT00272987|Drug|trastuzumab|4 mg/kg loading dose and 2 mg/kg weekly IV
16349177|NCT00272974|Behavioral|Clinic-based counseling|
16349178|NCT00272961|Drug|Placebo|placebo tablet once daily for 12 weeks
16349179|NCT00272961|Drug|TBC3711|10 mg tablets once daily for 10 weeks
16349180|NCT00272961|Drug|TBC3711|50 mg tablet once daily for 10 weeks
16349181|NCT00272961|Drug|TBC3711|100 mg tablet once daily for 10 weeks
16349182|NCT00272961|Drug|TBC3711|200 mg tablet once daily for 10 weeks
16349183|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d
16349184|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d iv in 4 doses beginning at day of conditioning until day +30 or until discharge from inpatient care (with a minimum treatment of 14 days) if VOD does not occur.
16349185|NCT00272948|Drug|Defibrotide|Defibrotide 25 mg/kg/d iv therapeutically when patients fulfil modified Seattle criteria
16349186|NCT00272935|Drug|Cenestin 0.3 mg Tablets|1 tablet daily
16349187|NCT00272935|Other|Placebo|1 tablet daily
16349188|NCT00272922|Device|hernia repair|
16349189|NCT00272909|Drug|piclozotan low dose|Continuous IV infusion over a period of up to 72 hours of piclozotan
16349190|NCT00272909|Drug|placebo|Continuous IV infusion over a period of up to 72 hours of placebo.
16349191|NCT00272909|Drug|piclozotan high dose|Continuous IV infusion over a period of up to 72 hours of piclozotan
16349192|NCT00272896|Drug|Vasoactive intestinal peptide|
16349193|NCT00272870|Drug|06Benzylguanine|120 mg/m2/day; given Day 1-5 for up to 6 courses in Block 3
16349194|NCT00272870|Genetic|MGMT P140K|Gene manipulated cells, patients are not expected to receive greater than approximately 10 x 10e6 transduced CD34+ cells/kg
16349195|NCT00272870|Device|Meltenyi CliniMacs|Device used for CD34+ cell separation of peripheral collection
16349196|NCT00272857|Genetic|Retrovirus Construct|This study will use an experimental gene transfer procedure performed in a laboratory to insert a new FA gene into the participant's bone marrow cells. The gene-corrected bone marrow cells will then be re-infused into the participant and participants will be observed for successful gene transfer
16349197|NCT00272844|Drug|crystalline cholesterol oil-based suspension|200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
16349198|NCT00272831|Drug|Cilostazol|Cilostazol 100 mg twice daily
16349199|NCT00272831|Drug|Placebo|1 tablet twice daily
16349200|NCT00272805|Drug|carvedilol|
16349201|NCT00272792|Drug|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
16349202|NCT00272792|Drug|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
16349203|NCT00272779|Drug|ATV|300mg Oral capsules for 96 weeks
16349204|NCT00272779|Drug|RTV|100mg Oral Capsules for 96 weeks
16349205|NCT00272779|Drug|Tenofovi-Emtricitabine (TDF/FTC) tablet|One tablet with 300 mg - 200 mg once a day for 96 weeks.
16349206|NCT00272779|Drug|LPV|400 mg (3 133mg capsules) BID for 96 weeks
16349207|NCT00272766|Drug|pegaptanib sodium|
16349208|NCT00272753|Drug|budesonide/formoterol Turbuhaler|
16349209|NCT00272753|Drug|formoterol Turbuhaler|
16349210|NCT00272753|Drug|salbutamol|
16349211|NCT00272740|Drug|Fulvestrant|
16349212|NCT00272727|Behavioral|Dialog tool for caregivers|
16349213|NCT00272714|Drug|Afimoxifene (0.057%) in hydroalcoholic gel|
16349214|NCT00272701|Drug|Esomeprazole|
16349215|NCT00272701|Drug|Other PPI marketed in Sweden|
16349216|NCT00272688|Drug|Levodopa (drug), intraduodenal administration|
16349217|NCT00272675|Drug|Chlorhexidine gluconate (drug) vs placebo|
16349218|NCT00272662|Drug|peginesatide|
16349219|NCT00272649|Biological|AGS-003|Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
16349220|NCT00272636|Procedure|Radiofrequency catheter ablation|
16349221|NCT00272636|Drug|Amiodarone and cardioversion|
16349222|NCT00272623|Procedure|Seldinger technique or venous cut-down for port placement|
16349223|NCT00272610|Drug|0.4% Retinol Cream|
16349224|NCT00272597|Drug|Risperidone|See Detailed Description.
16349225|NCT00272584|Drug|Risperidone|
16349226|NCT00272571|Procedure|External counter pulsation therapy|
16349227|NCT00272558|Drug|Carboplatin and Vinorelbine|
16349228|NCT00272545|Behavioral|Normalization of Eating (NOE)|The NOE is a 6-week program based on principles of CBT. Participants will receive individual therapy, as well as take part in group and family therapy sessions. In addition, participants will be supervised while eating meals.
16349229|NCT00272545|Behavioral|Treatment As Usual (TAU)|Treatment as usual will include standard care for a person with an eating disorder.
16349230|NCT00272532|Drug|Thiocolchicoside|
16349231|NCT00272519|Behavioral|Life Skills Intervention|Developed to promote life skills among young adolescents perinatally infected with HIV
16349232|NCT00272506|Drug|inhaled corticosteroid|
16349233|NCT00272506|Drug|long-acting beta2-agonist|
16349236|NCT00272480|Drug|Zidovudine/lamivudine|
16349237|NCT00272480|Drug|Placebos|
16349238|NCT00272467|Drug|Rebamipide|"Brand name: Mucosta® Tab.
~Generic name: Rebamipide.
~Chemical name:
~(±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid.
~Formulation: Tablet (White, film-coated tablet).
~Strength: One tablet contains rebamipide 100mg.
~Storage condition: 15℃~25℃.
~Manufacturer: Korea Otsuka Pharmaceuticals"
16349239|NCT00272467|Drug|Omeprazole|"Brand name: Losec® Cap.
~Generic name: Omeprazole.
~Chemical name:
~5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃~25℃. 7) Manufacturer: AstraZenaca Korea."
16349240|NCT00272454|Drug|Cilostazol|
16349241|NCT00272454|Drug|Aspirin|
16349242|NCT00272441|Drug|inhaled corticosteroids|
16349243|NCT00272428|Behavioral|ascorbic acid, vitamin E, beta carotene, selenium, zinc|
16349244|NCT00272415|Drug|INO-1001|Intravenous repeating dose
16349245|NCT00272415|Drug|temozolomide|Oral repeating dose
16349246|NCT00272402|Behavioral|Cognitive Behavioral Intervention|Intervention consists of simulated case based learning for physicians.
16349247|NCT00272402|Behavioral|Office System Redesign Intervention|Intervention consists of clinical decision support within the electronic medical record.
16349248|NCT00272350|Drug|Steroids|
16349249|NCT00272350|Drug|ZD6474|
16349250|NCT00272337|Drug|Aspirin|Dosage
16349251|NCT00272324|Drug|Aspirin|
16349252|NCT00272324|Drug|Folate|
16349253|NCT00272311|Drug|Aspirin|Dosage
16349254|NCT00272285|Drug|Ramosetron|IV, concomitant administration with dexamethasone
16349255|NCT00272285|Drug|Granisetron|IV, concomitant administration with dexamethasone
16349256|NCT00272272|Behavioral|Music Therapy|Listening to Music while standing
16349257|NCT00272259|Procedure|Participants will interact with up to two small robots and a visual display|
16349258|NCT00272246|Procedure|deep brain stimulation of the internal globus pallidus|
16349363|NCT00271271|Drug|oxaliplatine / gemcitabine / Vinorelbine|
16349364|NCT00271258|Drug|SODIUM DIVALPROATE|
16349259|NCT00272220|Behavioral|modified directly observed therapy (mDOT)|Peers individually administered the 6-week mDOT intervention at the Beira Day Clinic to mDOT participants during their morning weekday dose. Evening and weekend doses were not observed. Nighttime and weekend doses were self-administered. As part of the daily interaction with participants, peers provided social support, information about the benefits and side effects of HAART, how to address stigma's effect on adherence, and encouragement to participate in community support groups. The peers also provided an important link between the individual and other members of the HIV clinic team and the community.
16349260|NCT00272207|Drug|Nabilone|Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.
16349261|NCT00272194|Device|Ambu Laryngeal Mask|
16349262|NCT00272194|Device|Aintree Exchange Catheter|
16349263|NCT00272194|Device|Laryngeal Mask Airway|
16349264|NCT00272181|Drug|Proxinium|Intratumoral administration of Proxinium directly to target tumors.
16349265|NCT00272168|Behavioral|Maryland Program for Vocational Effectiveness|psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)
16349266|NCT00272168|Other|Supportive Treatment for SMI|Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
16349267|NCT00272155|Behavioral|Educational intervention|Educational outreach visits to the CME-groups, work-shops, audit and feedback
16349268|NCT00272155|Behavioral|Educational intervention program|The 433 recruited GPs had a total of 1336 717 office consultations of which 171 679 (12.8%) were RTIs encounters for 118 621 different patients. The GPs participated in peer continuing medical education (CME) groups in southern Norway. A multifaceted intervention was tailored, where key components were educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers conducted the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs were presented and software handed out for installation in participants PCs, enabling collection of prescription data. These data was linked to corresponding data from the Norwegian Prescription Database (NorPD). Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention.
16349269|NCT00272142|Drug|Zinc|
16349270|NCT00272142|Drug|Placebo|
16349271|NCT00272116|Drug|Zinc and vitamin A single dose at enrollment|10 mg/day of elemental zinc as zinc gluconate to infants and 20 mg/day to older children
16349272|NCT00272116|Drug|Placebo and vitamin A single dose at enrollment|Placebo was plain glucose. Vitamin A 100,000 IU to infants and 200,000 IU to older children
16349273|NCT00272103|Drug|Itopride (drug)|
16349274|NCT00272090|Drug|Insulin glargine|
16349275|NCT00272077|Drug|Insuline glargine|
16349276|NCT00272064|Drug|Insulin glulisine|individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal < 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous
16349277|NCT00272064|Drug|Insulin glargine|individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous
16349278|NCT00272064|Drug|Metformin|1000 mg b.i.d, since the qualification phase, oral
16349279|NCT00272051|Drug|SR57746A|
16349280|NCT00272038|Drug|Tarceva|150mg QD
16349281|NCT00272025|Drug|Escitalopram|10mg to 20mg tablet daily for 6 weeks
16349282|NCT00272025|Drug|placebo|
16349283|NCT00272012|Drug|Insulin glulisine|
16349284|NCT00271999|Behavioral|Nocturnal home hemodialysis|Six times per week nocturnal home hemodialysis
16349285|NCT00271973|Drug|Oxycodone|
16349286|NCT00271960|Behavioral|CenteringPregnancy|Following the initial intake into obstetric care in the usual manner, participants will be invited to join with 8 to 12 other women/couples/teens with similar due dates, meeting together regularly during their pregnancy.
16349287|NCT00271960|Behavioral|CenteringPregnancyPlus|CenteringPregnancyPlus is a modified program that integrated HIV/STD prevention components with the group prenatal care model. Participants will learn skill-building in the areas of efficacy, risk assessment, negotiation skills and prevention.
16349288|NCT00271960|Behavioral|Usual care|Participants will receive usual prenatal care.
16349289|NCT00271947|Biological|Autologous Stem Cell Transplantation|Autologous Stem Cell Transplantation will be performed after conditioning regimen
16349290|NCT00271934|Biological|Immune ablation and hematopoietic stem cell support.|Autologous hematopoietic stem cell transplant
16349291|NCT00271921|Behavioral|Calorie controlled diet|
16349292|NCT00271908|Behavioral|Community Mobilization|"ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P. Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change. ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site. Both cohorts will represent the site's target population, or population of focus."
16349293|NCT00271869|Procedure|Extracorporeal photoimmunotherapy|
16349294|NCT00271856|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|8 week MBSR course
16349295|NCT00271856|Behavioral|HIV-education and self-management workshop|8-week group covering a variety of educational topics about managing HIV infection.
16349296|NCT00271817|Drug|Comparator: ezetimibe/simvastatin + niacin (ER)|ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
16349297|NCT00271817|Drug|Comparator: Placebo to ezetimibe/simvastatin|ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
16349298|NCT00271817|Drug|Comparator: niacin (ER) tablet|niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
16349299|NCT00271817|Drug|Comparator: ezetimibe (+) simvastatin|ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
16349300|NCT00271817|Drug|Comparator: Placebo to Niacin (ER)|Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
16349301|NCT00271817|Drug|Comparator: ezetimibe/simvastatin and niacin (ER)|ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
16349302|NCT00271817|Drug|Comparator: ezetimibe and simvastatin|ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
16349303|NCT00271817|Drug|Comparator: Placebo to niacin (ER)|Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
16349304|NCT00271804|Drug|bortezomib|
16349305|NCT00271791|Drug|Prednisone|PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
16349306|NCT00271791|Drug|Prednisone|PO, Placebo, 17 days
16349307|NCT00271778|Procedure|mastoidotympanoplasty and tympanoplasty|
16349308|NCT00271765|Drug|INO-1001|
16349309|NCT00271752|Procedure|Earlier therapeutic changes regarding infection|For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified
16349310|NCT00271739|Device|Telemedicine Unit (HTU)|This study involves the deployment of a home telemedicine unit (HTU). The HTU provides 3 critical functions for patients: videoconferencing, access to information resources and e-mail through a web-enabled workstation, and medical data acquisition through an electronic device interface. The HTUs also included a glucometer and a blood pressure cuff interfaced directly with the HTU.
16349311|NCT00271739|Other|usual care|usual diabetes care, as provided by primary care providers
16349312|NCT00271726|Procedure|Osteosynthesis with palmar locking plate|
16349313|NCT00271726|Procedure|Osteosynthesis with external fixator|
16349314|NCT00271726|Procedure|Osteosynthesis with Kirschner wires|
16349315|NCT00271713|Drug|ibandronate, calcium and vitamin D|1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
16349316|NCT00271713|Drug|placebo,calcium and vitamin D|2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
16349317|NCT00271700|Behavioral|Order Set, Education, Feedback|
16349318|NCT00271687|Behavioral|Exercise training|
16349319|NCT00271674|Device|Q-switched YAG laser|
16349320|NCT00271635|Drug|Placebo|Placebo 4 capsules b.i.d. during 1 year
16349321|NCT00271635|Drug|ascorbic acid|Ascorbic acid 1000 mg (4 capsules of 250 mg) b.i.d. during 1 year
16349322|NCT00271609|Drug|Bevacizumab|10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.
16349323|NCT00271596|Drug|20mg daily citalopram|a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks
16349324|NCT00271596|Drug|Placebo|a daily matching placebo administered over 16 weeks
16349325|NCT00271583|Drug|CDB-2914|
16349326|NCT00271583|Drug|levonorgestrel|
16349327|NCT00271570|Drug|Infliximab (Remicade)|Remicade was 5 mg/kg IV (single dose)
16349328|NCT00271570|Biological|Intravenous immunoglobulin (IVIG)|2nd dose of IVIG (2g/kg)
16349329|NCT00271557|Drug|nesiritide|
16349330|NCT00271544|Device|Pacing Lead|implant and follow-up of study device
16349331|NCT00271518|Drug|growth hormone (somatropin)|dosing regimen is weight based.
16349332|NCT00271505|Drug|Bevacizumab (Avastin)|15 mg/kg intravenously (IV) every 3 weeks
16349333|NCT00271505|Drug|Carboplatin|AUC 6 IV every 3 weeks
16349334|NCT00271505|Drug|Docetaxel|75 mg/m2 IV every 3 weeks
16349335|NCT00271492|Drug|Atrasentan|1 10mg capsule to be taken daily for 6 month study period.
16349336|NCT00271492|Drug|Atrasentan|1 10mg capsule per day for the 6 month study period.
16349337|NCT00271492|Drug|atrasentan|One 10 mg capsule per day for 6 month study period
16349338|NCT00271479|Biological|A, C, Y, W135 meningococcal polysaccharide vaccine|
16349339|NCT00271466|Drug|DuragesicÂ® (fentanyl) Therapeutic Transdermal System (TTS)|
16349340|NCT00271453|Drug|Durogesic® (fentanyl transdermal drug delivery system)|
16349341|NCT00271440|Procedure|skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)|
16349342|NCT00271427|Drug|L-Selenomethionine|
16349343|NCT00271414|Drug|Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)|
16349344|NCT00271401|Other|Angioplasty|
16349345|NCT00271401|Other|Intracoronary Stent|
16349346|NCT00271401|Drug|Abxicimab|
16349347|NCT00271401|Drug|Heparin|
16349348|NCT00271401|Drug|Placebo|
16349349|NCT00271388|Device|Transcutaneous current to the vestibular nerve|Delivery of randomly oscillating low level current
16349350|NCT00271375|Behavioral|Caring For You, Caring For Me|5-week Education and Support Program for Caregivers of older adults.
16349351|NCT00271375|Behavioral|Caring for you, caring for me + social worker|5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
16349352|NCT00271375|Behavioral|Control|Control group usual care
16349353|NCT00271362|Behavioral|Amputation rehabilitation exercise program|participants will be physically exercised with a full array of exercise methodologies.
16349354|NCT00271362|Procedure|Osteomyoplasty vs. routine long posterior flap|participants enrolled randomly in one of two surgical procedures.
16349355|NCT00271349|Drug|Budesonide|
16349356|NCT00271336|Drug|Pentoxifylline|
16349357|NCT00271323|Drug|docetaxel and cisplatin|Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
16349358|NCT00271323|Radiation|radiotherapy|Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
16349359|NCT00271310|Drug|hypertonic saline|
16349360|NCT00271297|Behavioral|Pelvic floor muscle training|
16349361|NCT00271284|Drug|insulin glulisine / insulin glargine|insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
16349362|NCT00271284|Drug|insulin glulisin / insulin detemir|insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
16357696|NCT00199017|Drug|Thioguanine|
16349365|NCT00271245|Dietary Supplement|200 µg selenium as selenate|200 µg selenium as selenate
16349366|NCT00271245|Dietary Supplement|400 µg selenium as selenate|400 µg selenium as selenate
16349367|NCT00271245|Dietary Supplement|200 µg selenium as selenomethionine|200 µg selenium as selenomethionine
16349368|NCT00271245|Dietary Supplement|Placebo|Placebo
16349369|NCT00271232|Device|Cardiac resynchronization therapy|
16349370|NCT00271219|Drug|Methadone|daily oral dosing 20-140 mg
16349371|NCT00271219|Drug|Buprenorphine|sl daily 2-32 mg
16349372|NCT00271206|Drug|Progesterone|compared to placebo
16349373|NCT00271206|Drug|sugar pill|Compared to progesterone
16349374|NCT00271193|Behavioral|Weight loss counseling|A comparison of weight loss advice provided by primary care physicians to advice plus brief weight loss counseling provided by medical assistants. Participants in both groups receive weight loss materials.
16349376|NCT00271167|Drug|INO-1001|
16349377|NCT00271154|Device|Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT|All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
16349378|NCT00271115|Behavioral|Kangaroo Holding|Mothers will be asked to Kangaroo hold their infants two times during the first week of life.
16349379|NCT00271102|Procedure|anterior vaginal repair (colporrhaphy)|vaginal repair
16349380|NCT00271102|Procedure|abdominal paravaginal defect repair|abdominal repair
16349381|NCT00271089|Procedure|PBSC Collection|
16349382|NCT00271089|Procedure|Bone Marrow Harvest|
16349383|NCT00271089|Device|CliniMacs Cell Selection System|
16349384|NCT00271076|Procedure|IVUS|
16349385|NCT00271076|Device|CAS|
16349386|NCT00271076|Procedure|CEA|
16349387|NCT00271063|Drug|Liposomal Annamycin|3-day IV infusion
16349388|NCT00271050|Other|external beam radiotherapy plus 90-Y ibritumomab tiuxetan|combination of EBRT followed by radioimmunotherapeutic 90-Y ibritumomab tiuxetan
16349389|NCT00271037|Procedure|Colpocleisis prolapse repair surgery|
16349390|NCT00271037|Procedure|sling or other to treat or prevent stress incontinence|
16349391|NCT00271024|Drug|Naltrexone (drug)|50 mg q.d. for 13 weeks
16349392|NCT00271024|Drug|Placebo (for Naltrexone)|Sugar pill manufactured to mimic Naltrexone tablet
16349393|NCT00271011|Drug|Mitomycin C|Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
16349394|NCT00271011|Drug|Cetuximab|Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
16349395|NCT00271011|Drug|Irinotecan.|Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2.
16349396|NCT00270998|Behavioral|Behavioral Therapy|Pelvic muscle training and exercises
16349397|NCT00270998|Device|Intravaginal Pessary|Intravaginal pessary
16349398|NCT00270998|Device|Pessary combined with behavioral therapy|Intravaginal pessary and behavioral therapy
16349399|NCT00270985|Behavioral|Almonds in a calorie controlled diet|Prescribed daily dose of Almonds in calorie controlled diet for adults with pre-type 2 diabetes
16349400|NCT00270985|Behavioral|Nut free diet|Calorie controlled diet free of nuts for adults with pre-type 2 diabetes
16349401|NCT00270972|Device|Bilayered Cellular Matrix (OrCel)|
16349402|NCT00270959|Behavioral|Cognitive Behavioral Therapy|Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
16349403|NCT00270959|Behavioral|Motivational Interviewing|Motivational interviewing is designed to address alcohol and drug use.
16349404|NCT00270959|Drug|FDA-Approved Anti-Anxiety Medications|Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
16349405|NCT00270959|Behavioral|Standard Care Control|Standard care control includes the usual treatment for injured trauma survivors.
16349406|NCT00270946|Device|Bilayered Cellular Matrix (OrCel)|
16349407|NCT00270933|Device|Registry|
16349408|NCT00270920|Behavioral|Lactation counseling|
16349409|NCT00270907|Drug|CT-2103|135 mg/m^2 IV on Day 1.
16349410|NCT00270907|Drug|Gemcitabine|1000 mg/m^2 IV on Day 1 and 8.
16349411|NCT00270894|Drug|epirubicin|epirubicin (100 mg/m^2) every 2 weeks for 4 cycles
16349412|NCT00270894|Drug|cyclophosphamide|cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles
16349413|NCT00270894|Drug|docetaxel|docetaxel (75 mg/m^2) every 2 weeks for 4 cycles
16349414|NCT00270894|Drug|trastuzumab|trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments
16349415|NCT00270881|Procedure|Cord blood transplantation|unrelated cord blood transplantation
16349416|NCT00270881|Radiation|TBI|Total body irradiation (TBI) 12Gy
16349417|NCT00270881|Drug|cyclophosphamide|cyclophosphamide 120mg/kg
16349418|NCT00270881|Drug|cytarabine|cytarabine 3g/m2x4
16349419|NCT00270868|Procedure|Double guide wire technique|
16349420|NCT00270868|Procedure|Standard bile duct cannulation|
16349421|NCT00270855|Procedure|Arm Crank Ergometry|Use of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
16349422|NCT00270855|Procedure|FES Cycle Ergometer|Use of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
16349423|NCT00270842|Behavioral|Tai Chi|This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
16349885|NCT00267046|Drug|Vincristine|2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.
16349424|NCT00270842|Behavioral|Functional Balance|This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
16349425|NCT00270842|Behavioral|Education Control group|This control group participated in 10 weeks of general health education classes.
16349426|NCT00270829|Drug|nesiritide|Drug given intrarenally or placebo
16349427|NCT00270816|Drug|Interferon-ß-1b|250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
16349428|NCT00270816|Drug|Interferon ß-1b|250 micrograms (8 MIU) administered subcutaneously (sc) every other day
16349429|NCT00270803|Drug|Tetra Hydro Cannabinol (THC)|Oral THC 13mg and 17mg smoked in low nicotine cigarettes
16349430|NCT00270790|Drug|Amifostine|Amifostine will be given at dose of 500 mg IV within one hour before radiation
16349431|NCT00270790|Drug|Carboplatin|Carboplatin for 100 mg/m2 and will be administered after the taxol infusion
16349432|NCT00270790|Drug|Taxol|Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose
16349433|NCT00270790|Device|Radiotherapy|Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
16349434|NCT00270777|Drug|adrenaline, promethazine, hydrocortisone|
16349435|NCT00270751|Procedure|1 apical pleurectomy|
16349436|NCT00270751|Procedure|2 pleural abrasion + minocycline pleurodesis|
16349437|NCT00270738|Procedure|Indirect training of the PFMs via transversus abdominis|Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.
16349438|NCT00270738|Procedure|pelvic floor muscle training|Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
16349439|NCT00270738|Procedure|home exercise|PFM exercise at home: at least six high-intensity (near-maximum) contractions 3 times per day at home, with an aim at holding each muscle contraction for 10 seconds, with at least a 10-second rest between contractions.
16349440|NCT00270699|Biological|rDEN4delta30-200,201|Live attenuated dengue 4 vaccine (one of three doses)
16349441|NCT00270699|Biological|Placebo|Placebo for rDEN4delta30-200,201
16349442|NCT00270673|Procedure|Early lactate-directed therapy|
16349443|NCT00270660|Behavioral|biopsy, audiometry, ET function test, ear swab culture, DNE|
16349444|NCT00270647|Dietary Supplement|Vitamin E|400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
16349445|NCT00270647|Dietary Supplement|Vitamin C|500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
16349446|NCT00270647|Dietary Supplement|Multivitamin|Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
16349447|NCT00270647|Dietary Supplement|Beta-carotene|50 mg Lurotin or placebo on alternate days (provided by BASF)
16349448|NCT00270634|Drug|Voclosporin|voclosporin 0.4, 0.6, 0.8 mg/kg po BID
16349449|NCT00270634|Drug|tacrolimus|tacrolimus 0.05 mg/kg po BID
16349450|NCT00270621|Behavioral|FHP Night time ENuresis Intervention|Urine alarm/evidence-based psychological Intervention
16349451|NCT00270608|Procedure|Quantitative Computed Tomography of the tibia and spine|a single time 1 minute procedure
16349452|NCT00270608|Procedure|MRI of the spine and the right knee|a single time 45 minutes procedure
16349453|NCT00270608|Procedure|Blood test|A single time procedure to check lipid profile and hemoglobin A1C
16349454|NCT00270582|Drug|Taxotere, Cisplatin, Gemcitabine|
16349455|NCT00270569|Drug|PhyxolTM, Cisplatin|
16349456|NCT00270556|Drug|tenofovir disoproxil fumarate|
16349457|NCT00270556|Drug|Abacavir|
16349458|NCT00270543|Drug|Taxotere, Fluorouracil, Leucovorin|
16349459|NCT00270530|Drug|Sulfadoxine-pyrimethamine (Fansidar)|
16349460|NCT00270517|Drug|EDP-420 / Duration of Treatment - 3 days|
16349461|NCT00270517|Drug|Telithromycin / Duration of Treatment - 7 days|
16349462|NCT00270504|Device|Memokath stenting|Urethral Stenting
16349463|NCT00270491|Drug|Paclitaxel|
16349464|NCT00270491|Drug|Capecitabine|
16349465|NCT00270478|Drug|Erythropoietin and Hydroxyurea|
16349466|NCT00270465|Drug|VRC-HIVDNA016-00-VP|
16349467|NCT00270465|Drug|VRC-HIVADV014-00-VP|
16349468|NCT00270452|Drug|WT1 and PR1 Peptide Vaccine|
16349469|NCT00270439|Procedure|removal of omentum|patients with type 2 diabetes had their omentum removed
16349470|NCT00270426|Drug|Benazepril|
16349471|NCT00270413|Drug|SU11248|sutent 50 mg daily 4w on 2w off
16349472|NCT00270400|Drug|nesiritide|
16349473|NCT00270387|Drug|Natrecor (nesiritide)|
16349474|NCT00270374|Drug|nesiritide|
16349475|NCT00270361|Drug|nesiritide|
16349476|NCT00270361|Drug|usual long term cardiac medications|
16349477|NCT00270361|Drug|nesiritide|
16349478|NCT00270348|Drug|ciclesonide|
16349479|NCT00270335|Drug|Propofol|
16349480|NCT00270322|Drug|Marcaine 0.166% + Fentanyl 3.33 mcg/ml|
16349481|NCT00270322|Drug|Morphine sulphate|
16349482|NCT00270309|Behavioral|Self-management|
16349483|NCT00270296|Drug|Trizivir|300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
16349484|NCT00270296|Drug|Lamivudine/Zidovudine|150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
16349485|NCT00270296|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
16349486|NCT00270296|Drug|Nevirapine|200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
16349487|NCT00270283|Drug|epoetin alfa|
16349488|NCT00270270|Drug|epoetin alfa|
16349489|NCT00270257|Drug|Buprenorphine/Naloxone|Oral tablet
16349490|NCT00270244|Behavioral|Group interpersonal psychotherapy for depressed adolescents (IPT-AG)|Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships.
16349654|NCT00268931|Behavioral|Movement Training|This group of infants underwent specific movement training activities two times per day with their parents.
16349491|NCT00270244|Behavioral|Treatment as usual (TAU)|TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.
16349492|NCT00270231|Drug|Naltrexone|"All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period.
~Dosing of the naltrexone was the same for all participants: Day 1: 12.5mg, Day 2: 25mg, Days 3 and 4: 50mg."
16349493|NCT00270231|Drug|Placebo|"All participants took a placebo (sugar pill) during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo.
~Placebo capsules matched the naltrexone in color, weight and inactive ingredients. The only difference the lack of active naltrexone in each capsule."
16349494|NCT00270218|Biological|VRC-HIVADV014-00-VP|HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid
16349495|NCT00270218|Biological|VRC-HIVDNA009-00-VP|HIV-1 DNA plasmid vaccine given as a 1 mL intramuscular injection in the deltoid
16349496|NCT00270218|Biological|FFB|Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid
16349497|NCT00270218|Biological|PBS|phosphate buffered saline
16349498|NCT00270205|Biological|LC002 standard vaccination|0.1 mg DNA/participant, 0.8 ml total administered subcutaneously
16349499|NCT00270205|Biological|LC002 high-dose vaccination|0.4 mg DNA/participant, 3.2 ml total administered subcutaneously
16349500|NCT00270205|Biological|LC002 placebo vaccination|Placebo vaccination administered subcutaneously
16349501|NCT00270192|Behavioral|individual lactation counseling and educational material|
16349502|NCT00270192|Behavioral|educational material alone|
16349503|NCT00270192|Behavioral|routine antenatal care without educational intervention|
16349504|NCT00270179|Drug|epoetin alfa|
16349505|NCT00270166|Drug|epoetin alfa|
16349506|NCT00270153|Drug|enalapril|5mg enalapril daily for 6 months
16349507|NCT00270153|Drug|Placebo|5mg enalapril-matching placebo daily for 6 months
16349508|NCT00270140|Drug|epoetin alfa|
16349509|NCT00270127|Drug|Epoetin alfa|
16349510|NCT00270114|Drug|epoetin alfa|
16349511|NCT00270101|Drug|epoetin alfa|
16349512|NCT00270088|Drug|epoetin alfa|
16349513|NCT00270075|Drug|epoetin alfa|
16349514|NCT00270062|Drug|epoetin alfa|
16349515|NCT00270049|Drug|epoetin alfa|
16349516|NCT00270036|Drug|epoetin alfa|
16349517|NCT00270023|Drug|epoetin alfa|
16349518|NCT00270010|Drug|epoetin alfa|
16349519|NCT00269997|Drug|epoetin alfa|
16349520|NCT00269984|Drug|Epoetin alfa|
16349521|NCT00269971|Drug|epoetin alfa|
16349522|NCT00269958|Drug|epoetin alfa|
16349523|NCT00269945|Drug|epoetin alfa|
16349524|NCT00269932|Drug|levofloxacin|
16349525|NCT00269919|Drug|Risperidone Long-Acting Injectable (RLAI)|The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
16349526|NCT00269906|Drug|Abciximab|
16349527|NCT00269906|Drug|Placebo|
16349528|NCT00269893|Drug|Abciximab|0.25 mg/kg of body weight of abciximab either bolus or infusion.
16349529|NCT00269893|Drug|Placebo|Matching Placebo soulution either bolus or infusion.
16349530|NCT00269880|Drug|Placebo|Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
16349531|NCT00269880|Drug|Heparin|Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
16349532|NCT00269880|Drug|Abciximab|Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
16349533|NCT00269867|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
16349534|NCT00269867|Drug|Infliximab 3 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
16349535|NCT00269867|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
16349536|NCT00269854|Drug|Infliximab 5 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
16349537|NCT00269854|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
16349538|NCT00269854|Drug|Infliximab 20 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6.
16349539|NCT00269854|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2 and 6.
16349540|NCT00269841|Drug|Infliximab 10 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
16349541|NCT00269841|Drug|Infliximab 5 mg/kg|Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
16349542|NCT00269841|Drug|Placebo|Matching placebo will be adminstered at Week 0, 2 and 6.
16349543|NCT00269828|Drug|paclitaxel|
16349544|NCT00269828|Drug|paclitaxel poliglumex|
16349545|NCT00269815|Drug|methylphenidate HCl|
16349546|NCT00269802|Drug|OROS methylphenidate HCl|
16349547|NCT00269802|Drug|Ritalin|
16349548|NCT00269802|Drug|Placebo|
16349549|NCT00269789|Drug|Ritalin|
16349550|NCT00269789|Drug|OROS Methylphenidate HCl|
16349551|NCT00269789|Drug|Placebo|
16349552|NCT00269776|Drug|Placebo|Treatment C: Three OROS placebo tablets once daily + 1 placebo capsule 3x times/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
16349655|NCT00268931|Behavioral|Social Training|This group underwent special social interactions with their parents two times each day.
16349656|NCT00268918|Drug|Docetaxel|Participants may continue receiving study drug as long as their disease does not worsen
16349553|NCT00269776|Drug|OROS (methylphenidate HCl)|Treatment A: 1, 2, or 3 OROS methylphenidate 18-mg tablets + 0, 1, or 2 OROS placebo tablets (3 tablets in total) once daily + 1 placebo capsule 3x/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
16349554|NCT00269776|Drug|Ritalin (methylphenidate)|Treatment B: 5, 10, or 15-mg tablets (encapsulated/single capsule) 3 times a day + 3 OROS placebo tablets once daily for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.
16349555|NCT00269763|Drug|Fentanyl Transdermal Therapeutic System (TTS)|
16349556|NCT00269750|Drug|OROS® oxybutynin or Ditropan®|
16349557|NCT00269737|Drug|Fentanyl Transdermal Therapeutic System (TTS)|
16349558|NCT00269724|Drug|OROS® oxybutynin|
16349559|NCT00269685|Drug|vasopressin|
16349560|NCT00269672|Biological|13-valent Pneumococcal Conjugate Vaccine|
16349561|NCT00269646|Behavioral|Low-carbohydrate and high-carbohydrate diets|Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.
16349562|NCT00269633|Device|Blue Light Box 467 nm|467 nm Blue LED Light
16349563|NCT00269633|Device|Red Light Box 657 nm|657 nm Red LED Light
16349564|NCT00269620|Drug|ethinyl estradiol/etonogestrel vaginal ring|vaginal ring for cyclic use (3 weeks in, 1 week out)
16349565|NCT00269620|Drug|ethinyl estradiol/norelgestromin transdermal contraceptive|contraceptive patch worn for 7 days and replaced for use for 3 consecutive weeks followed by a one-week patch free interval
16349566|NCT00269607|Drug|Implantation of naltrexone implants|
16349567|NCT00269594|Drug|Lamictal (lamotrigine)|
16349568|NCT00269581|Other|Educational CD-rom|Educational CD-Rom
16349569|NCT00269581|Other|Headstrong CD-rom|Headstrong CD-rom
16349570|NCT00269568|Drug|mifepristone and misoprostol|
16349571|NCT00269555|Drug|Genistein Combined Polysaccharide (GCP)|
16349572|NCT00269542|Drug|Zinc and iron folic acid - Intervention|The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
16349573|NCT00269542|Drug|Iron Folic Acid alone - Placebo|The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
16349574|NCT00269529|Procedure|femoral nerve block|
16349575|NCT00269529|Procedure|knee infiltration and injection via catheter|
16349576|NCT00269516|Drug|pardoprunox|fixed dose 6 mg
16349577|NCT00269516|Drug|Pardoprunox|fixed dose 12 mg
16349578|NCT00269516|Drug|Pardoprunox|12-42mg
16349579|NCT00269516|Drug|Placebo|Placebo
16349580|NCT00269503|Procedure|Prone Distraction|
16349581|NCT00269503|Procedure|Side-Posture Manipulation|
16349582|NCT00269503|Procedure|Side-Posture Manipulation & Prone Distraction|
16349583|NCT00269503|Procedure|Usual Care (Control Group)|
16349584|NCT00269490|Behavioral|Yoga Nidra|
16349585|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16349586|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16349587|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16349588|NCT00269477|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16349589|NCT00269438|Drug|5 ASA, enemas, suppositories, corticosteroids|
16349590|NCT00269425|Behavioral|American Heart Association Step 2 diet|Low fat diet with patient education and diet analysis
16349591|NCT00269425|Behavioral|Mediterranean diet|Mediterranean style diet with patient education and diet analysis
16349592|NCT00269412|Drug|Rifaximin|
16349593|NCT00269399|Drug|Rifaximin (Xifaxan)|
16349594|NCT00269399|Drug|Vancomycin|
16349595|NCT00269386|Drug|Clarithromycin|Clarithromycin S/R 1g once daily April 2004 - Clarithromycin S/R (Klaricid XL) ceased to be abailable and subsequent patients will receive standard Clarithromycin 500mg bd
16349596|NCT00269386|Drug|Placebo|
16349597|NCT00269373|Procedure|PET-CT|no drugs included
16349598|NCT00269360|Procedure|Chiropractic + Supervised Rehabilitative Exercise|"Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
~Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises."
16349599|NCT00269360|Procedure|Supervised Rehabilitative Exercise|Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
16349600|NCT00269360|Behavioral|Self-care education|Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
16349601|NCT00269347|Procedure|Chiropractic Spinal Manipulation|
16349602|NCT00269347|Procedure|Exercise|
16349603|NCT00269347|Behavioral|Self-care|
16349604|NCT00269334|Drug|Using Citalopram(drug) or Paroxetine(drug)|
16349605|NCT00269321|Procedure|Chiropractic Manual treatment + home exercise (procedure+behavior)|"The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy.
~Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active."
16349657|NCT00268918|Drug|PTK787|Participants may continue receiving study drug as long as their disease does not worsen
16349886|NCT00267046|Drug|Cisplatin|120 mg/m^2 on day 0, for patients receiving the AP Regimen.
16357697|NCT00199017|Drug|HDARAC|
16349606|NCT00269321|Procedure|Supervised rehabilitative exercise+home exercise|"The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists.
~Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active."
16349607|NCT00269321|Behavioral|Home exercise|Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
16349608|NCT00269308|Procedure|Chiropractic Manual treatment + home exercise ( procedure+behavior)|"The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy.
~Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"
16349609|NCT00269308|Procedure|Supervised rehabilitative exercise + home exercise|"The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements.
~Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"
16349610|NCT00269308|Behavioral|Home exercise|Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
16349611|NCT00269295|Biological|Ty800|Live attenuated Ty800 S typhi oral vaccine is co-administered with a sodium bicarbonate buffer solution. Dosages: 5 X 10^7 cfu, 5 X 10^8 cfu, and 5 X 10^9 cfu.
16349612|NCT00269295|Drug|Placebo|150 mL of the prepared sodium bicarbonate buffer solution. Placebo will look and taste essentially like the study product.
16349613|NCT00269282|Behavioral|Self-Management Training|Asthma education and self-monitoring strategies
16349614|NCT00269282|Behavioral|Motivational Interviewing (MI)|Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.
16349615|NCT00269269|Drug|antihypertensive drug|
16349616|NCT00269269|Behavioral|placebo|
16349617|NCT00269243|Drug|Quinapril|
16349618|NCT00269230|Device|Pacing Lead|Left ventricular pacing lead
16349619|NCT00269217|Drug|niacin (+) laropiprant (+) simvastatin|Duration of Treatment 12 Weeks
16349620|NCT00269217|Drug|Comparator: niacin (+) laropiprant|Duration of Treatment 12 Weeks
16349621|NCT00269217|Drug|Comparator: simvastatin|Duration of Treatment 12 Weeks
16349622|NCT00269204|Drug|niacin (+) laropiprant|Duration of Treatment - 24 weeks
16349623|NCT00269204|Drug|ER-niacin|Duration of Treatment - 24 weeks
16349624|NCT00269191|Drug|MK0663, etoricoxib / Duration of Treatment 12 Weeks|
16349625|NCT00269191|Drug|Placebo or Ibuprofen / Duration of Treatment 12 Weeks|
16349626|NCT00269178|Behavioral|Peer Health Education Programme|
16349627|NCT00269165|Procedure|Balloon Aortic Valvuloplasty|
16349628|NCT00269165|Procedure|External Beam Radiation|
16349629|NCT00269152|Drug|pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
16349630|NCT00269152|Drug|cisplatin|75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
16349631|NCT00269152|Drug|carboplatin|area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
16349632|NCT00269139|Behavioral|Crisis resolution|
16349633|NCT00269126|Drug|fluticasone propionate/salmeterol combination DISKUS|
16349634|NCT00269126|Drug|salmeterol xinafoate|
16349635|NCT00269113|Drug|rituximab [MabThera/Rituxan]|375mg/m2 iv monthly for 8 cycles
16349636|NCT00269113|Drug|Standard chemotherapy|As prescribed
16349637|NCT00269087|Drug|fluticasone propionate/salmeterol combination DISKUS|
16349638|NCT00269074|Drug|IDEA-070|
16349639|NCT00269061|Drug|pioglitazone|
16349640|NCT00269048|Drug|SB-480848|SB-480848
16349641|NCT00269048|Drug|placebo|placebo
16349642|NCT00269035|Drug|SB773812|SB-773812 tablets will be available with dose strength of 60 mg
16349643|NCT00269035|Drug|Risperidone|Risperidone tablets will be available with dose strength of 3 and 6 mg
16349644|NCT00269022|Drug|SB-705498|
16349645|NCT00269009|Behavioral|CHERL|
16349646|NCT00268996|Drug|SB-480848|SB-480848 is available as enteric-coated, free-base micronized tablet
16349647|NCT00268996|Drug|SB-480848 matching placebo|Placebo is available as enteric-coated, free-base micronized tablet
16349648|NCT00268983|Biological|Tositumomab and Iodine I 131 Tositumomab|"Dosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes
~Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes."
16349649|NCT00268983|Biological|Rituximab|Rituximab 375 mg/m2 given as an IV infusion once weekly for four weeks.
16349650|NCT00268970|Drug|Satraplatin in combination with Paclitaxel|Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.
16349651|NCT00268957|Drug|Sevelamer carbonate (Renvela®)|sevelamer carbonate powder dosed once per day with largest meal
16349652|NCT00268957|Drug|Sevelamer hydrochloride (Renagel®)|Sevelamer hydrochloride tablets dosed three times a day with meals
16349653|NCT00268944|Biological|Myozyme|20 mg/kg qow
16349779|NCT00268216|Drug|Salmeterol 50mcg/ Fluticasone Propionate 500mcg|
16349658|NCT00268905|Drug|E7389 + carboplatin AUC 5|Patients will receive E7389 before (Schedule A) or after (Schedule B) carboplatin AUC 5 infusion. E7389 will be administered as a 2-5 minute intravenous (IV) bolus infusion at a starting dose of 0.7 mg/m^2 on Days 1 and 8 every 21 days. Carboplatin 5 AUC will be administered as a 30-minute IV infusion on Day 1 every 21 days. Dose escalation will be performed in cohorts of three patients per dose level per schedule.
16349659|NCT00268905|Drug|E7389 + carboplatin AUC 6|"After MTD is reached with carboplatin AUC 5, dose escalation of E7389 in combination with carboplatin at AUC 6 will begin at one dose level below MTD, using the preferred schedule (A or B).
~If carboplatin AUC 6 with E7389 is tolerated, the MTD reached will be used to enroll 20 additional patients with Stage IIIB or IV non-small cell lung cancer (NSCLC). If carboplatin AUC 6 is not tolerated, these patients will be enrolled at the MTD determined with the combination of E7389 and carboplatin AUC 5."
16349660|NCT00268905|Drug|E7389+carboplatin AUC 6|In a population of patients who had generally received multiple prior chemotherapies, the eribulin MTD has been determined to be 1.1 mg/m2 in combination with carboplatin at an AUC of 6. The first-line NSCLC patients in the extension arm may tolerate a higher dose of eribulin, because they have not been exposed to the toxicity of other chemotherapies. To investigate this possibility, the dose of eribulin will be increased to 1.4 mg/m2 for subsequent patients, if the first six of these patients do not experience a DLT during their first cycle of eribulin at 1.1 mg/m2 and carboplatin at AUC 6 combination therapy. If no more than one of the first six patients experience a DLT during the first cycle with the 1.4 mg/m2 dose of eribulin, then the 1.4 mg/m2 dose will be considered the recommended dose for front-line NSCLC therapy and the remaining patients will be treated using this dose.
16349661|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
16349662|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
16349663|NCT00268892|Drug|Degarelix|"Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
~Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study."
16349664|NCT00268879|Drug|Renzapride|Placebo Renzapride 4 mg QD Renzapride 2 mg BID
16349665|NCT00268866|Behavioral|Education|
16349666|NCT00268853|Drug|CPOP-R|Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
16349667|NCT00268853|Drug|CHOP-R|Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
16349668|NCT00268840|Drug|Docetaxel|Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
16349669|NCT00268840|Drug|Gemcitabine|Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
16349670|NCT00268827|Drug|Kaletra soft-gel capsules switched to Kaletra tablets|
16349671|NCT00268827|Device|MOS-HIV Health and Medication Satisfaction Survey, Global Conditioning Improvement and Therapy Preference Questionnaire|
16349672|NCT00268814|Drug|Diacetylmorphine|Diacetylmorphine (i.v.), daily
16349673|NCT00268814|Behavioral|Psycho-education and Counselling|Psycho-educational group therapy and individual counselling
16349674|NCT00268814|Drug|Methadone|Methadone (p.o.), daily
16349675|NCT00268814|Behavioral|Case management and Motivational interviewing|Individual Case Management combined with Motivational interviewing
16349676|NCT00268788|Drug|Subcutaneous immunoglobulin|Individually dosed, given twice a week.
16349677|NCT00268788|Drug|Intravenous immunoglobulin|Individual dose and frequency
16349678|NCT00268775|Behavioral|training and follow-up of pharmacists|
16349679|NCT00268775|Behavioral|patient-directed discontinuation letter|
16349680|NCT00268762|Drug|argatroban|Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
16349681|NCT00268749|Drug|glycine|0.8 g/kg/day
16349682|NCT00268723|Drug|Levalbuterol tartrate HFA MDI|levalbuterol MDI 90 mcg QID
16349683|NCT00268723|Drug|Placebo|Placebo MDI QID
16349684|NCT00268710|Drug|docetaxel|
16349685|NCT00268697|Drug|Lapaquistat acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 24 weeks.
16349686|NCT00268697|Drug|Lapaquistat acetate and ezetimibe|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
16349687|NCT00268697|Drug|Ezetimibe|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
16349688|NCT00268684|Drug|Erlotinib, Temozolomide|
16349689|NCT00268671|Drug|Docetaxel|
16349690|NCT00268658|Device|SmartStep(tm) biofeedback device|
16349691|NCT00268645|Drug|Insulin Glargine|
16349692|NCT00268632|Drug|risedronate|
16349693|NCT00268619|Drug|Ramipril|
16349694|NCT00268606|Behavioral|cognitive-behavioral therapy|
16349695|NCT00268593|Drug|PI-88|Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.
16349696|NCT00268593|Drug|docetaxel|Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.
16349697|NCT00268593|Drug|prednisone|5 mg twice a day orally
16349698|NCT00268580|Behavioral|Asthma Care Pathway|Asthma care provided using standardized asthma care pathway
16349699|NCT00268567|Drug|leflunomide combined with prednisone|
16349700|NCT00268554|Drug|dipyridamole|
16349701|NCT00268554|Drug|caffeine|
16349702|NCT00268541|Behavioral|Physical activity|
16349951|NCT00266253|Drug|GK Activator (2)|Escalating doses, po bid or qd for 12 weeks.
16349703|NCT00268528|Behavioral|Compliance Monitoring|Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
16349704|NCT00268528|Other|Laboratory Biomarker Analysis|Correlative studies
16349705|NCT00268528|Drug|Mercaptopurine|Given PO
16349706|NCT00268528|Drug|Methotrexate|Given PO
16349707|NCT00268528|Other|Questionnaire Administration|Ancillary studies
16349708|NCT00268528|Other|Study of Socioeconomic and Demographic Variables|Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
16349709|NCT00268515|Drug|cyclosporine|
16349710|NCT00268515|Drug|tacrolimus|
16349711|NCT00268515|Drug|prednisone|
16349712|NCT00268515|Drug|azathioprine|
16349713|NCT00268502|Other|study of socioeconomic and demographic variables|
16349714|NCT00268502|Procedure|fatigue assessment and management|
16349715|NCT00268502|Procedure|management of therapy complications|
16349716|NCT00268502|Procedure|psychosocial assessment and care|
16349717|NCT00268502|Procedure|quality-of-life assessment|
16349718|NCT00268489|Biological|bevacizumab|
16349719|NCT00268489|Drug|pemetrexed disodium|
16349720|NCT00268476|Drug|Celecoxib|
16349721|NCT00268476|Drug|Docetaxel|
16349722|NCT00268476|Drug|Prednisolone|
16349723|NCT00268476|Drug|ADT|
16349724|NCT00268476|Drug|Zoledronic Acid|
16349725|NCT00268476|Drug|Abiraterone|
16349726|NCT00268476|Radiation|Radiotherapy to the prostate|
16349727|NCT00268476|Drug|Enzalutamide|
16349728|NCT00268476|Drug|Metformin|
16349729|NCT00268476|Drug|Transdermal Oestradiol|
16349730|NCT00268463|Drug|capecitabine|"Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1
~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2"
16349731|NCT00268463|Drug|floxuridine|Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
16349732|NCT00268463|Drug|oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1
~Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2"
16349733|NCT00268450|Biological|bevacizumab|"Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles
~After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles"
16349734|NCT00268450|Drug|cisplatin|Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles
16349735|NCT00268450|Drug|gemcitabine hydrochloride|Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
16349736|NCT00268450|Drug|paclitaxel|After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles
16349737|NCT00268450|Procedure|cysectomy|
16349738|NCT00268437|Drug|carboplatin|carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
16349739|NCT00268437|Drug|Pemetrexed|Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
16349740|NCT00268437|Procedure|conventional surgery|
16349741|NCT00268437|Procedure|neoadjuvant therapy|
16349742|NCT00268437|Radiation|radiation therapy|Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
16349743|NCT00268411|Drug|gemcitabine hydrochloride|
16349744|NCT00268411|Drug|oxaliplatin|
16349745|NCT00268398|Drug|oxaliplatin, folinic acid, fluorouracil|folinic acid 200 mg/m² (day 1&2) oxaliplatin 85 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1&2) continuous 5FU 600mg/m² (day 1 to 2)
16349746|NCT00268398|Drug|oxaliplatin, irinotecan, folinic acid, fluorouracil|"FOLFOX7 folinic acid 400 mg/m² (day 1) oxaliplatin 130 mg/m² (day 1) continuous 5FU 3000mg/m² (day 1 to 2)
~FOLFIRI folinic acid 400 mg/m² (day 1) irinotecan 180 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1) continuous 5FU 2400mg/m² (day 1 to 2)"
16349747|NCT00268385|Other|Laboratory Biomarker Analysis|Correlative studies
16349748|NCT00268385|Other|Pharmacological Study|Correlative studies
16349749|NCT00268385|Drug|Temozolomide|Given orally
16349750|NCT00268385|Drug|Vorinostat|Given orally
16349751|NCT00268372|Drug|cisplatin|
16349752|NCT00268372|Drug|docetaxel|
16349753|NCT00268372|Drug|5-fluorouracil|
16349754|NCT00268372|Procedure|surgery|
16349755|NCT00268372|Radiation|radiation therapy|
16349756|NCT00268359|Biological|bevacizumab|
16349757|NCT00268359|Drug|irinotecan hydrochloride|
16349758|NCT00268346|Drug|ZD1839|ZD1839 treatment will be taken once a day PO, every day about the same time
16349759|NCT00268333|Drug|fluorouracil|
16349760|NCT00268333|Drug|leucovorin calcium|
16349761|NCT00268333|Drug|oxaliplatin|
16349762|NCT00268333|Procedure|neoadjuvant therapy|
16349763|NCT00268320|Device|Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator|
16349764|NCT00268307|Drug|Autologous, Unfractionated Bone Marrow Mononuclear Cells|Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.
16349765|NCT00268294|Device|Cardiac Resynchronization Therapy|
16349766|NCT00268281|Device|Left Ventricular Capture Management Software|
16349767|NCT00268255|Drug|gefitinib|
16349768|NCT00268255|Procedure|adjuvant therapy|
16349769|NCT00268255|Procedure|enzyme inhibitor therapy|
16349770|NCT00268255|Procedure|neoadjuvant therapy|
16349771|NCT00268255|Procedure|protein tyrosine kinase inhibitor therapy|
16349772|NCT00268255|Procedure|radiation therapy|
16349773|NCT00268255|Procedure|radiosensitization|
16349774|NCT00268242|Drug|Gemcitabine Hydrochloride|10 mg/m2/ min IV for 12 hours
16349775|NCT00268242|Drug|Mitoxantrone Hydrochloride|12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3
16349776|NCT00268229|Drug|cytarabine|300 mg/m2/day
16349777|NCT00268229|Drug|daunorubicin hydrochloride|45 mg/m2/day
16349778|NCT00268229|Drug|imatinib mesylate|dose escalation (300 mg/day to 800 mg/day).
16350055|NCT00265551|Drug|SCA-136 (200 mg)|
16349780|NCT00268203|Biological|Iodine I 131 Tositumomab Therapeutic Regimen|Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
16349781|NCT00268177|Drug|Salmeterol/fluticasone propionate 50/500mcg Diskus|
16349782|NCT00268164|Drug|lactobacilus acidophilus & bifidobacterium animalis/lactis|
16349783|NCT00268151|Drug|Oxaliplatin|
16349784|NCT00268151|Drug|Capecitabine|
16349785|NCT00268138|Drug|elmex gel|elmex gel once a week
16349786|NCT00268125|Device|Acupression's bracelet|
16349787|NCT00268125|Behavioral|Hygiene and dietetic advices|
16349788|NCT00267969|Drug|ustekinumab|Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.
16349789|NCT00267969|Drug|placebo|Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.
16349790|NCT00267956|Drug|CNTO 1275 63 mg|The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16.
16349791|NCT00267956|Drug|Placebo|The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
16349792|NCT00267943|Drug|telmisartan 80 mg + hydrochlorothiazide 25 mg|
16349793|NCT00267930|Drug|Vernakalant (oral)|
16349794|NCT00267930|Drug|Placebo comparator|
16349795|NCT00267917|Device|Berodual Respimat|
16349796|NCT00267917|Device|Berodual HFA-MDI|
16349801|NCT00267865|Drug|Methotrexate|6000 mg/m^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
16349802|NCT00267865|Drug|Rituximab|375 mg/m^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
16349803|NCT00267865|Drug|Leucovorin|Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
16349804|NCT00267852|Other|as clinical practice|Dosage, form, frequency and duration as per ordinary clinical practice
16349805|NCT00267839|Behavioral|physical exercise, wellness|
16349806|NCT00267826|Drug|Rituximab|Intravenous infusion of 1000mg Rituximab (anti-CD20) on days 1 and 15 to patients with atopic dermatitis
16349807|NCT00267813|Drug|Bupropion (Zyban)|1 tablet a day increasing to 2 tablets a day after a week
16349808|NCT00267787|Other|genetic analysis|standard of care
16349809|NCT00267774|Device|Fractional flow reserve|
16349810|NCT00267774|Procedure|Angio-guided PCI|
16349811|NCT00267748|Drug|Sunitinib Malate Continuous Daily Dosing|Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
16349812|NCT00267748|Drug|Sunitinib Malate Schedule 4/2|Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
16349813|NCT00267735|Behavioral|Use of Computerized Decision Aid on Childbirth|
16349814|NCT00267722|Drug|Visilizumab|
16349815|NCT00267709|Drug|Visilizumab|
16349816|NCT00267696|Drug|Bevacizumab|Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
16349817|NCT00267696|Drug|Gemcitabine|A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
16349818|NCT00267696|Drug|Carboplatin|
16349819|NCT00267683|Drug|insulin aspart|
16349820|NCT00267683|Drug|glibenclamide|
16349821|NCT00267670|Drug|Pentoxifylline|400mg PO TID
16349822|NCT00267670|Drug|Placebo|1 pill PO TID
16349823|NCT00267657|Drug|Reserpine|
16349824|NCT00267618|Behavioral|FHP Pain|Evidence-based psychological and behavioural Intervention
16349825|NCT00267605|Behavioral|FHPADHD|Evidence-based psychological and behavioural distance intervention
16349826|NCT00267605|Behavioral|ADHD Standard Care|
16349827|NCT00267592|Drug|Talampanel|Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
16349828|NCT00267592|Radiation|Radiation Therapy (RT) 5 days a week +|
16349829|NCT00267592|Drug|temozolomide(TMZ) 75mg|temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
16349830|NCT00267592|Drug|adjuvant TMZ 200mg|adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
16349831|NCT00267579|Behavioral|Strongest Families (formerly Family Help Program): Behaviour Disorder Program|Evidence-based psychological and behavioural Distance Intervention
16349832|NCT00267566|Behavioral|Strongest Families (formerly Family Help Program): Anxiety Program|Evidence-based psychological and behavioural distance intervention
16349833|NCT00267553|Drug|Atamestane|
16349834|NCT00267553|Drug|toremifene|
16349835|NCT00267553|Drug|letrozole|
16349836|NCT00267540|Behavioral|cholecalciferol (D3) (vitamin)|
16349837|NCT00267527|Drug|CJC 1295|
16349838|NCT00267514|Drug|sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)|sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
16349839|NCT00267514|Drug|sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)|sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
16349840|NCT00267488|Drug|topotecan|
16349841|NCT00267449|Device|SoftScan Optical Breast Imaging System|
16349842|NCT00267436|Behavioral|Community PROMISE|The Community PROMISE begins with a community assessment to identify HIV risk factors. Once risk factors have been identified, individuals from the targeted at-risk community are recruited and trained to be peer advocates. Trained peer advocates interview members of the community about their behavior. Role model stories are written based on the interviews. Role model stories are personal accounts from individuals in the target population which explain how and why they took steps to practice HIV risk-reduction behaviors and the positive effects the choice has had on their lives. Each week, peer advocates distribute role model stories and supplies, such as condoms, to 10 to 20 members of their social networks.
16349843|NCT00267410|Behavioral|Healthy Relationships|"Healthy Relationships, grounded in the social cognitive theory, is a five-session, group-level intervention originally designed for HIV-positive heterosexual individuals seeking skills-building and support around risk reduction, as well as disclosure of status and sexual preference. Through clip media and active role-plays, the intervention promotes the development of decision-making and problem-solving tools, empowering participants to make voluntary and informed decisions around disclosure and safer sex practices. This model was formally disseminated to AIDS Service Organizations as part of CDC's strategic plan - Advancing HIV Prevention, New Strategies for a Changing Epidemic - which focused on innovative strategies to recruit individuals into HIV testing, as well as a movement towards secondary prevention efforts."
16349844|NCT00267384|Drug|Oral N-Acetylcysteine|
16349845|NCT00267371|Device|PFO Closure with Premere investigational device.|PFO Closure with Premere investigational device.
16349846|NCT00267371|Drug|Medical management/current medications per standard of care by personal physician.|Medical management with current medications per standard of care by personal physician.
16349847|NCT00267358|Drug|RC-1291 HCl|
16349848|NCT00267358|Drug|Placebo|
16349849|NCT00267332|Drug|Modafinil|
16349850|NCT00267319|Drug|Glatiramer acetate|
16349851|NCT00267306|Drug|Visilizumab|
16349852|NCT00267293|Drug|Acetaminophen|Given for fever control 15mg/kg
16349853|NCT00267293|Drug|Ibuprofen|Given for fever control 10 mg/kg
16349854|NCT00267280|Drug|torcetrapib/atorvastatin|
16349855|NCT00267280|Drug|simvastatin|
16349856|NCT00267267|Drug|torcetrapib/atorvastatin|
16349857|NCT00267267|Drug|ezetimibe/simvastatin|
16349858|NCT00267254|Drug|torcetrapib/atorvastatin|
16349859|NCT00267254|Drug|simvastatin|
16349860|NCT00267241|Other|Mechanical Ventilation|Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)
16349861|NCT00267215|Drug|Lumiracoxib|
16349862|NCT00267202|Drug|Placebo|Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.
16349863|NCT00267202|Drug|Omalizumab|Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.
16349864|NCT00267202|Drug|Immunotherapy|"Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or maintenance solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours."
16349865|NCT00267202|Drug|Immunotherapy|"Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or maintenance solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours."
16349866|NCT00267189|Drug|Everolimus|1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation
16349867|NCT00267189|Drug|Calcineurin inhibitors (CNI)|
16349868|NCT00267189|Drug|Mycophenolate acid (MPA)/ Azathioprine (AZA)|
16349869|NCT00267189|Drug|Steroids|
16349870|NCT00267176|Drug|lumiracoxib|
16349871|NCT00267163|Drug|donepezil|
16349872|NCT00267163|Drug|Placebo|
16349873|NCT00267150|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|Experimental
16349874|NCT00267137|Device|Pacing Algorithms|
16349875|NCT00267111|Drug|Eucerin plus|1g, single application
16349876|NCT00267111|Drug|Amethocaine gel 4%|1 g, single application
16349877|NCT00267098|Device|Cardiac Resynchronization Therapy (CRT)|Biventricular pacing
16349878|NCT00267098|Device|Cardiac Resynchronization Therapy (CRT)|Right ventricular pacing
16349879|NCT00267085|Biological|Synthetic Tumor-Specific Breakpoint Peptide Vaccine|CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months
16349880|NCT00267059|Drug|Lenalidomide|10 mg/day, orally once a day for 28 days
16349881|NCT00267046|Drug|Palifermin|180 mcg/kg 3 days prior to chemotherapy
16349882|NCT00267046|Drug|Placebo|Single dose 3 days prior to chemotherapy
16349883|NCT00267046|Drug|Adriamycin (Doxorubicin)|30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
16349884|NCT00267046|Drug|Ifosfamide|2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen.
16350056|NCT00265551|Drug|SCA-136 (400 mg)|
16349887|NCT00267033|Procedure|injection of orthopaedic cement into vertebral bodies|injection of orthopaedic cement into vertebral bodies
16349888|NCT00267020|Drug|enzastaurin|1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles
16349889|NCT00267020|Drug|gemcitabine|1000 milligrams/square meter (mg/m^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
16349890|NCT00267007|Drug|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC)
16349891|NCT00267007|Drug|Placebo|Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)
16349892|NCT00266981|Device|APOS - exercise component|
16349893|NCT00266929|Procedure|surgical|surgical treatment of odontoid fractures
16349894|NCT00266929|Procedure|conservative treatment|conservative stabilization of fractures
16349895|NCT00266877|Drug|HKI-272|320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
16349896|NCT00266864|Drug|Testosterone Transdermal System (Androderm 5 mg patch)|Testosterone Transdermal System (Androderm 5 mg patch)
16349897|NCT00266851|Drug|Azithromycin|600 mg x 3 days, then 600 mg weekly x 11 weeks
16349898|NCT00266851|Drug|Placebo|Matching placebo
16349899|NCT00266838|Drug|Maxidex; Lacrystat|6 times daily, for 20 weeks.
16349900|NCT00266825|Drug|DHA|600 mg DHA
16349901|NCT00266825|Other|Placebo capsule|Placebo capsule
16349902|NCT00266812|Drug|Temozolomide and radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
16349903|NCT00266812|Procedure|Whole brain radiotherapy|2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
16349904|NCT00266799|Drug|Pegylated liposomal doxorubicin (SCH 200746)|pegylated liposomal doxorubicin (50 mg/m^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity
16349905|NCT00266799|Drug|Capecitabine|capecitabine (1250 mg/m^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity
16349906|NCT00266786|Drug|Intranasal Ketorolac Tromethamine|Intranasal at 30mg
16349907|NCT00266786|Drug|Intranasal Placebo|Intranasal Placebo
16349908|NCT00266773|Behavioral|Chronic pain therapeutic interactive voice response (TIVR) system|Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls
16349909|NCT00266747|Drug|SR58611A|
16349910|NCT00266734|Device|RPS Adeno Detector|
16349911|NCT00266721|Drug|Pancrelipase (Creon) 2 tablets with each meal|
16349912|NCT00266708|Drug|Risedronate|risedronate 35 mg weekly
16349913|NCT00266708|Drug|Placebo|Risedronate Placebo 35 mg weekly
16349914|NCT00266695|Drug|Ruboxistaurin|32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
16349915|NCT00266682|Device|Pacing Lead|
16349916|NCT00266669|Drug|Topical organogel with nitroglycerin|
16349917|NCT00266656|Drug|Humatrope|According to investigator's clinical practice and guided by the approved package insert
16349918|NCT00266643|Drug|duloxetine hydrochloride|
16349919|NCT00266630|Drug|olanzapine|oral, daily
16349920|NCT00266630|Drug|lithium|Dose adjusted according to local package insert
16349921|NCT00266630|Drug|valproate|Dose adjusted according to local package insert
16349922|NCT00266630|Drug|carbamazepine|Dose adjusted according to local package insert
16349923|NCT00266617|Drug|epoetin alfa|
16349924|NCT00266604|Drug|Topiramate|
16349925|NCT00266591|Drug|topiramate|
16349926|NCT00266578|Drug|Fluticasone Propionate|Flovent vs. placebo daily for 3 months
16349927|NCT00266565|Drug|Mepolizumab|10mg/kg (max 750 ml) once a month for 3 months
16349928|NCT00266552|Drug|risperidone|
16349929|NCT00266539|Drug|E-TRANS Fentanyl hydrochloride; Morphine|
16349930|NCT00266526|Biological|Recombinant birch pollen|
16349931|NCT00266487|Drug|Folic acid|
16349932|NCT00266487|Drug|Vitamin B12|
16349933|NCT00266487|Drug|Vitamin B6|
16349934|NCT00266474|Other|Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.|
16349935|NCT00266461|Drug|Daikenchuto Extract Granules (TU-100)|
16349936|NCT00266448|Drug|Chlorhexidine solution 4%|
16349937|NCT00266409|Drug|Niravam|
16349938|NCT00266409|Drug|SSRI/SNRI|Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
16349939|NCT00266396|Behavioral|Recommend full weight-bearing|The full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery
16349940|NCT00266396|Behavioral|Recommend parital weight-bearing|The partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg
16349941|NCT00266357|Drug|MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)|
16349942|NCT00266357|Drug|Placebo / Duration of Treatment: 2 days for screening period|
16349943|NCT00266344|Drug|MK0928, gaboxadol / Duration of Treatment 3 Weeks|
16349944|NCT00266344|Drug|Placebo / Duration of Treatment 3 Weeks|
16349945|NCT00266331|Drug|Reduced glutathione|
16349946|NCT00266318|Drug|Interferon Alfacon-1 and Ribavirin|
16349947|NCT00266305|Behavioral|Fish oil (Dry n-3, BASF)|5 g/oil daily for the first four month of lactation
16349948|NCT00266292|Behavioral|Fish oil (Bio-Marine, Pharma Nord)|
16349949|NCT00266292|Behavioral|n-6 PUFA intake (Margarine+sunflower oil vs. butter product+rapeseed oil)|
16349950|NCT00266279|Drug|Oxaliplatin, Capecitabine|"Agent, DOSE AND SCHEDULE (28-days cycle):
~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
16350057|NCT00265551|Drug|olanzapine (15 mg)|
16349952|NCT00266253|Drug|Metformin|As prescribed, for 12 weeks
16349953|NCT00266240|Drug|GK Activator (2)|Escalating doses po bid
16349954|NCT00266240|Drug|Placebo|po bid
16349955|NCT00266227|Drug|placebo|Intravenous repeating dose
16349956|NCT00266227|Drug|rituximab|Intravenous repeating dose
16349957|NCT00266227|Drug|methotrexate|Oral or parenteral repeating dose
16349958|NCT00266227|Drug|folate|Intravenous repeating dose
16349959|NCT00266214|Drug|lidocaine patch 5%|1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime
16349960|NCT00266162|Drug|Bosentan administration|
16349961|NCT00266149|Drug|Oral contraception|
16349962|NCT00266149|Drug|Lamotrigine|
16349963|NCT00266136|Drug|Cytarabine|see protocol
16349964|NCT00266136|Drug|Thioguanine|see protocol
16349965|NCT00266136|Drug|Daunorubicin|see protocol
16349966|NCT00266136|Drug|Cyclophosphamide|see protocol
16349967|NCT00266136|Drug|G-CSF|see protocol
16349968|NCT00266136|Procedure|Autologous stem cell transplantation|for details see protocol
16349969|NCT00266136|Procedure|Allogeneic stem cell transplantation|for details see protocol
16349970|NCT00266123|Drug|Sirolimus|
16349971|NCT00266110|Biological|sargramostim|All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.
16349972|NCT00266110|Biological|therapeutic autologous dendritic cells|patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.
16349973|NCT00266110|Biological|trastuzumab|Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration. If the subject has previously received Trastuzumab within 30 days and has no adverse history with the drug, the infusion will be given over 30 minutes. If the subject is currently receiving Trastuzumab, the first study infusion will be given at 4mg/kg over 30 minutes. Subsequently, Trastuzumab will be infused at 4 mg/kg in the side-port of a freely flowing IV over 30 minutes.
16349974|NCT00266110|Drug|vinorelbine ditartrate|Vinorelbine 25 mg/m2 will be administered IV over six to ten minutes into the side port of a freely flowing IV line.
16349975|NCT00266097|Drug|erlotinib hydrochloride|Cohort (-1) = 50 mg daily Cohort 1 = 50mg daily Cohort 2= 75 mg daily Cohort 3 = 100mg daily Cohort 4 = 100mg daily Cohort 5 = 150mg daily
16349976|NCT00266097|Drug|gemcitabine hydrochloride|Gemcitabine will be given at a dose of 100 mg/m2 for the first cohort and escalated to a fixed dose of 200 mg/m2 for the remaining 3 cohorts
16349977|NCT00266097|Drug|oxaliplatin|Oxaliplatin will be given at 30 mg/m2 weekly for the first two cohorts and then will be dose-escalated to 45 mg/m2 and 60 mg/m2 for the next 2 in cohorts
16349978|NCT00266097|Radiation|radiation therapy|5040 cGy, every week, up to 6 weeks
16349979|NCT00266097|Drug|gemcitabine hydrochloride|Given weekly at a starting dose of 100mg/m2 in the first 3 cohorts and dose escalated to 200 mg/m2 for the remaining 2 cohorts
16349980|NCT00266097|Drug|Oxaliplatin|The Part II dose of oxaliplatin will be determined by Part I of the study. The dose for Part II will be one dose level increase from the MTD determined in Part I.
16349981|NCT00266071|Behavioral|Cutaneous response|
16349982|NCT00266058|Drug|Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine|participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)
16349983|NCT00266032|Drug|Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
16349984|NCT00266032|Drug|Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
16349985|NCT00266032|Drug|Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
16349986|NCT00266019|Behavioral|Weight Management (diet, exercise, and behavior modification)|
16349987|NCT00266006|Drug|eptacog alfa (activated)|
16349988|NCT00265993|Drug|enoxaparin|"All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days.
~Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months."
16349989|NCT00265980|Drug|Subcutaneous Placebo|Twice daily injections of saline in the same volume as will be used for leptin injections.
16349990|NCT00265980|Drug|Leptin|Leptin will be given as twice daily subcutaneous injections in doses titrated to replicate 8 a.m. circulating leptin concentrations measured in the same subjects prior to weight loss.
16349991|NCT00265967|Drug|Irbesartan|Irbesartan 150-300 mg/d for 8 weeks
16349992|NCT00265954|Behavioral|internet, in-person and internet+in-person|All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
16349993|NCT00265941|Drug|cetuximab|Cetuximab 400 mg/m^2 IV loading dose 5-7 days before start of radiation therapy, then 250 mg/m^2 IV weekly for 7 weeks
16349994|NCT00265941|Drug|cisplatin|Cisplatin 100 mg/m^2 IV on days 1 and 22
16349995|NCT00265941|Radiation|Accelerated Fractionation by Concomitant Boost|3DCRT 54 Gy in 30 1.8 Gy fractions over 6 weeks with boost 18 Gy in 12 1.5 Gy fractions for last 12 days, for a total of 72 Gy in 42 fractions over 6 weeks
16349996|NCT00265941|Radiation|Intensity-modulated radiation therapy|70 Gy in 35 2.0 Gy fractions over 6 weeks with 6 fractions per week (on Saturday or as second daily fraction) in 5 of the 6 weeks.
16349997|NCT00265928|Drug|bortezomib|
16349998|NCT00265928|Drug|rituximab|
16349999|NCT00265928|Procedure|antibody therapy|
16350000|NCT00265928|Procedure|biological therapy|
16350001|NCT00265928|Procedure|enzyme inhibitor therapy|
16350002|NCT00265928|Procedure|monoclonal antibody therapy|
16350003|NCT00265915|Biological|rituximab|
16350004|NCT00265915|Biological|sargramostim|
16350005|NCT00265902|Procedure|diagnostic imaging|
16350006|NCT00265889|Biological|filgrastim|480 mcg beginning day +5
16350007|NCT00265889|Drug|busulfan|11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
16350008|NCT00265889|Drug|cyclophosphamide|60 mg/kg IV over 2 hours x 2 days
16350009|NCT00265889|Drug|etoposide|60 mg/kg, IV
16350010|NCT00265889|Drug|melphalan|150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
16350011|NCT00265889|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|autologous-autologous tandem hematopoietic stem cell transplantation
16350012|NCT00265889|Radiation|radiation therapy|radiation therapy
16350013|NCT00265876|Drug|AZD0530|Taken daily every 4 weeks
16350014|NCT00265876|Drug|gemcitabine hydrochloride|1000mg/m2 IV weekly
16350015|NCT00265863|Drug|mitomycin C|Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
16350016|NCT00265850|Biological|bevacizumab|Given IV
16350017|NCT00265850|Biological|cetuximab|Given IV
16350018|NCT00265850|Drug|FOLFOX or|Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours
16350019|NCT00265850|Drug|FOLFIRI|Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.
16350020|NCT00265837|Biological|graft versus host disease prophylaxis/therapy|
16350021|NCT00265837|Procedure|allogeneic bone marrow transplantation|
16350022|NCT00265837|Procedure|in vitro-treated bone marrow transplantation|
16350023|NCT00265824|Drug|bevacizumab|bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
16350024|NCT00265824|Drug|bevacizumab, erlotinib|bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
16350025|NCT00265811|Drug|Folfox|
16350026|NCT00265811|Drug|Cetuximab|
16350028|NCT00265785|Drug|pemetrexed|Pemetrexed 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
16350029|NCT00265772|Drug|MODULEN IBD (R) (specific Enteral Nutrition)|
16350030|NCT00265772|Drug|prednisolon|
16350031|NCT00265759|Drug|anastrozole|Given PO
16350032|NCT00265759|Drug|exemestane|Given PO
16350033|NCT00265759|Drug|letrozole|Given PO
16350034|NCT00265759|Procedure|Therapeutic Conventional Surgery|Undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection
16350035|NCT00265746|Drug|Metformin|
16350036|NCT00265746|Behavioral|Lifestyle intervention - diet, physical activity|
16350037|NCT00265733|Drug|capecitabine|
16350038|NCT00265733|Drug|paclitaxel poliglumex|
16350039|NCT00265720|Other|Control|Written materials only
16350040|NCT00265720|Other|Reduced out of pocket expense|Reimbursed up to $500 out of pocket expense for CRC screening
16350041|NCT00265720|Behavioral|one on one education|one on one education with a health educator
16350042|NCT00265720|Behavioral|Group education|Education in a small group
16350043|NCT00265707|Device|Blood pressure measurement|
16350044|NCT00265694|Drug|vinorelbine, gemcitabine and carboplatin|
16350045|NCT00265681|Behavioral|Phone counseling and written materials|
16350046|NCT00265655|Drug|Satraplatin|Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
16350047|NCT00265642|Drug|Irbesartan|one tablet of 150 mg/d during 2 years
16350048|NCT00265642|Drug|placebo|one tablet per day during 2 years
16350049|NCT00265629|Device|RF catheter ablation|RF ablation using mesh device
16350050|NCT00265616|Drug|propofol|liquid, mg/kg.h, titrated after EEG
16350051|NCT00265616|Drug|thiopental/pentobarbital|liquid, mg/kg.h, titrated after EEG
16350052|NCT00265603|Procedure|Extracorporeal Photochemotherapy With Transimmunization|The photopheresis apparatus and procedure will be identical to that currently used. Patients will receive intravenous 8-MOP (UVADEX®) directly into the photopheresis apparatus, to yield a concentration of 50-200 ng/ml of drug. The blood will be leukapheresed to obtain a buffy coat and will then be passed through the contiguous closed circuit ultraviolet A exposure device, delivering the desired 1-2 joules/cm2 of ultraviolet A energy. In this manner 2-4 molecules of 8-MOP will be induced to bind covalently to thymines of the leukocyte DNA. At that point, the single variation from the standard treatment will be initiated. Instead of returning the patient's cells and the saline to the patient, the bag will be detached from the apparatus. KLH (depyrogenated, endotoxin-free; Calbiochem-Novabiochem Corp., San Diego, CA) will be added at a concentration of 10 g/ml to the DC-rich leukocyte culture prior to overnight culture.
16350053|NCT00265564|Behavioral|Modified Seeking Safety integrated into std outpatient SUD care|The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
16350054|NCT00265564|Behavioral|Standard outpatient SUD care|"Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence."
16350059|NCT00265538|Behavioral|Patient educational letter to engage provider in hypertension rx discussion|Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.
16350060|NCT00265538|Behavioral|Financial incentive (Arms B and C) and health educator phone call (Arm C)|Patients may receive a financial incentive for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the financial incentive discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt. The Financial incentive is part of both Arms B and C. The health educator phone call is only in Arm C.
16350061|NCT00265525|Behavioral|CardioFit|CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.
16350062|NCT00265512|Behavioral|Telephone Case Monitoring|Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
16350063|NCT00265512|Behavioral|Continuing Care as Usual|Continuing Care as Usual will include standard group outpatient SUD treatment.
16350064|NCT00265499|Procedure|Skeletonization of the internal thoracic artery|
16350065|NCT00265486|Drug|Recombinant human Erythropoietin|Adm 100 U/kg sc 1 hour before completing exercise in protocol
16350066|NCT00265473|Biological|Allogeneic Islets of Langerhans|Intraportal infusion of islets of Langerhans
16350067|NCT00265460|Drug|Oliwer Twist smokeless tobacco (tobacco)|
16350068|NCT00265447|Behavioral|Strength training|3 months of strength training
16350069|NCT00265447|Behavioral|Aerobic conditioning|3 months of aerobic conditioning
16350070|NCT00265447|Behavioral|Delayed exercise|delayed exercise control group
16350071|NCT00265434|Drug|Pulmozyme|
16350072|NCT00265421|Procedure|Suture technique for perineal repair after delivery|
16350073|NCT00265408|Drug|aspirin|
16350074|NCT00265408|Drug|warfarin|
16350075|NCT00265395|Drug|Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)|"Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks"
16350076|NCT00265395|Drug|Combination of pegylated interferon alfa-2b and ribavirin|"Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.
~200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks"
16350077|NCT00265382|Drug|Ziprasidone oral capsules|Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.
16350078|NCT00265369|Drug|Spores of Bacillus Clausii Probiotic Strain|
16350079|NCT00265356|Procedure|PET diagnostic imaging|PET diagnostic imaging
16350080|NCT00265343|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
16350081|NCT00265343|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
16350082|NCT00265330|Drug|Ziprasidone oral capsules|Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
16350083|NCT00265317|Drug|erlotinib|erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
16350084|NCT00265317|Drug|sunitinib|Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
16350085|NCT00265317|Drug|erlotinib|erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
16350086|NCT00265317|Drug|placebo|Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
16350087|NCT00265304|Drug|Ketoprofen|
16350088|NCT00265291|Drug|fluoxetine or desipramine|fluoxetine 5-40 mg/day desipramine 50-150 mg/day
16350089|NCT00265278|Drug|Modafinil|
16350090|NCT00265265|Drug|Atomoxetine|
16350091|NCT00265252|Drug|Alendronate|
16350092|NCT00265239|Drug|edaravone|intravenous administration of 30mg Edaravone just before reperfusion therapy
16350093|NCT00265226|Biological|Intra-dermal administration of Mycobacterium w|Mw Vaccine is given as oral suspension. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
16350094|NCT00265200|Drug|zoledronic acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
16350095|NCT00265148|Drug|Rosiglitazone|Extended Release Tablets
16350096|NCT00265148|Other|Placebo|Placebo dummy to match
16350097|NCT00265135|Drug|CNTO 328|Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.
16350098|NCT00265122|Drug|Ustekinumab 90 mg|one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
16350099|NCT00265122|Drug|Ustekinumab 4.5 mg/kg|one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
16350100|NCT00265122|Drug|Placebo SC|one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
16358401|NCT00193440|Drug|CVP|
16350101|NCT00265122|Drug|Placebo IV|one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
16350102|NCT00265109|Drug|Levetiracetam|The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
16350103|NCT00265096|Biological|golimumab|50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
16350104|NCT00265096|Biological|Placebo; golimumab|SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
16350105|NCT00265096|Biological|golimumab|100 mg sc injections every 4 wks from wk 0 up to 5 yrs
16350106|NCT00265083|Biological|golimumab|100 mg sc injections every 4 wks from wk 0 up to 5 yrs
16350107|NCT00265083|Biological|Golimumab (CNTO 148); placebo|SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg
16350108|NCT00265083|Biological|golimumab|50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
16350109|NCT00265070|Drug|Gefitinib|250 mg tablet oral daily dose
16350110|NCT00265057|Drug|ADH -1 (Exherin™)|
16350111|NCT00265044|Behavioral|Provider Education|
16350112|NCT00265044|Behavioral|Hypertension Alert|
16350113|NCT00265044|Behavioral|Patient Education|
16350114|NCT00265031|Drug|Cyclophosphamide|
16350115|NCT00265031|Drug|Adriamycin|
16350116|NCT00265031|Drug|Etoposide|
16350117|NCT00265031|Drug|Procarbazine|
16350118|NCT00265031|Drug|Prednisone|
16350119|NCT00265031|Drug|Vincristine|
16350120|NCT00265031|Drug|Bleomycin|
16350121|NCT00265031|Procedure|radiation therapy|
16350122|NCT00265018|Drug|Adriamycin|
16350123|NCT00265018|Drug|Bleomycin|
16350124|NCT00265018|Drug|Vinblastine|
16350125|NCT00265018|Drug|DTIC|
16350126|NCT00265018|Radiation|30 Gy IF-RT|
16350127|NCT00265018|Radiation|20 Gy IF-RT|
16350128|NCT00265005|Drug|alteplase|Iv administration of 1 mg/ml up to two times and 2 mg/ml if needed.
16350129|NCT00264979|Procedure|Simultaneous surgery|Simultaneous surgery of colorectal cancer and synchronous liver metastases
16350130|NCT00264979|Procedure|Sequential surgery|Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
16350131|NCT00264966|Drug|ASM8|
16350132|NCT00264953|Drug|Adriamycin|
16350133|NCT00264953|Drug|Bleomycin|
16350134|NCT00264953|Drug|Vinblastine|
16350135|NCT00264953|Drug|DTIC|
16350136|NCT00264953|Drug|Etoposide|
16350137|NCT00264953|Drug|Procarbazine|
16350138|NCT00264953|Drug|Prednisone|
16350139|NCT00264953|Drug|Vincristine|
16350140|NCT00264953|Radiation|radiation therapy|20 or 30Gy IF-RT
16350141|NCT00264927|Drug|SR121463B|
16350142|NCT00264914|Drug|SR121463B|
16350143|NCT00264901|Drug|insulin detemir|
16350144|NCT00264888|Drug|PTC124|
16350145|NCT00264875|Drug|pregabalin|75mg BID, titrated up to 300mg according to individual response and tolerability
16350146|NCT00264862|Procedure|DynaCT|
16350147|NCT00264849|Drug|Omalizumab|Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.
16350148|NCT00264849|Other|Optimized asthma therapy|Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
16350149|NCT00264823|Behavioral|Use of Memory Aids to take medications|Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.
16350150|NCT00264810|Procedure|RNS® System implantation|Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
16350151|NCT00264810|Device|RNS® System responsive stimulation|The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
16350267|NCT00263783|Drug|MEDI-522|MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.]
16350152|NCT00264797|Drug|Methylphenidate (OROS-MPH)|Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
16350153|NCT00264797|Drug|Methylphenidate (OROS-MPH) - Placebo|Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
16350154|NCT00264758|Device|Conventional hemodialysis|Three times per week in-center hemodialysis
16350155|NCT00264758|Device|Frequent hemodialysis|Six times per week in-center hemodialysis
16350156|NCT00264745|Behavioral|TASK intervention|The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.
16350157|NCT00264745|Behavioral|Attention Control|Minimal intervention beyond initial hospital visit.
16350158|NCT00264732|Drug|Amolimogene|1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
16350159|NCT00264732|Drug|Amolimogene|3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
16350160|NCT00264732|Other|Placebo|Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.
16350161|NCT00264719|Drug|Metoclopramide (Maxolon)|Mothers will be given metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10 and once a day from 11th to 12th day
16350162|NCT00264719|Drug|placebo|placebo 10 mg
16350163|NCT00264706|Drug|Nona-L-arginine|
16350164|NCT00264680|Drug|lamotrigine|
16350165|NCT00264680|Drug|valproic acid|
16350166|NCT00264667|Drug|GW677954|
16350167|NCT00264654|Drug|BRL29060A|
16350168|NCT00264654|Drug|paroxetine hydrochloride hydrate|
16350169|NCT00264641|Drug|Human insulin|Hyperinsulinaemic induced hypoglycaemia
16350170|NCT00264628|Drug|GW679769|
16350171|NCT00264615|Drug|lamotrigine extended-release|
16350172|NCT00264602|Drug|Near Infrared Imaging|Dye injected into or around tumor at the time of surgery
16350173|NCT00264589|Behavioral|8 weeks individualized training program|no drugs added
16350174|NCT00264576|Biological|Influenza Virus Vaccine|
16350175|NCT00264563|Behavioral|Increasing the level of awareness to Iatrogenesis|Increasing the level of awareness to Iatrogenesis
16350176|NCT00264563|Behavioral|Increasing awareness .|Increasing awareness to Iatrogenesis and active daily recordings
16350177|NCT00264550|Drug|Golimumab 100 mg|Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
16350178|NCT00264550|Drug|Golimumab 50 mg|Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
16350179|NCT00264550|Drug|Methotrexate|Participants will receive methotrexate capsules weekly.
16350180|NCT00264550|Drug|Placebo injection|Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
16350181|NCT00264550|Drug|Placebo capsules|Participants will receive placebo capsules weekly
16350182|NCT00264537|Drug|Placebo injections|SC injections
16350183|NCT00264537|Drug|Placebo capsules|Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).
16350184|NCT00264537|Drug|Methotrexate capsules|Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.
16350185|NCT00264537|Biological|Golimumab 50 mg injections|SC injections
16350186|NCT00264537|Biological|Golimumab 100 mg injections|SC injections
16350187|NCT00264524|Procedure|venipuncture to withdraw patient's blood|
16350188|NCT00264511|Procedure|Hyperbaric Oxygenation|Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.
16350189|NCT00264498|Drug|Gefitinib|oral tablet
16350190|NCT00264498|Drug|Gemcitabine|intravenous injection
16350191|NCT00264498|Drug|Carboplatin|intravenous injection
16350192|NCT00264485|Drug|E-TRANS Fentanyl hydrochloride; Morphine|
16350193|NCT00264472|Drug|ADH300004|5 mg
16350194|NCT00264459|Biological|Grass pollen formulation|"Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
~The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter."
16350195|NCT00264459|Other|Comparator|Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
16350196|NCT00264446|Drug|ADH300004|
16350197|NCT00264433|Drug|ADH -1 (Exherin™)|
16350198|NCT00264420|Drug|zoledronic acid|At baseline 4 mg IV zoledronic acid over 15 min. every 4 weeks for 6 months plus radiation therapy 30 Gy in 10 fractions (5 times per week for first two weeks)
16350199|NCT00264407|Drug|Hormone Replacement Therapy - HRT|
16350200|NCT00264394|Behavioral|Updated CHD risk profiles|Provision of computer generated CHD risk profiles
16350201|NCT00264394|Behavioral|Guidelines|provision of guidelines for CHD risk factor management only
16350202|NCT00264381|Drug|Dalteparin sodium injection|Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.
16350203|NCT00264368|Drug|intravenous (IV) ganciclovir|
16350204|NCT00264355|Drug|cyclosporine A|
16350205|NCT00264329|Other|Transitional Case Management Study|In an effort to address problems involved in parole re-entry, the Transitional Case Management (TCM) intervention tested a model of strengths-based case management consisting of (1) completion by the inmate of a strengths and goals assessment as part of discharge planning, (2) a telephone conference call that included the inmate and people central to the inmate's aftercare plan (including the parole officer), and (3) strengths case management for 12 weeks in the community to promote treatment participation and increase the client's access to needed services.
16350206|NCT00264316|Procedure|bone marrow-derived stem cell transfer|
16350207|NCT00264303|Drug|Levocetirizine|5mg oral capsules, once daily, 4 week duration
16350208|NCT00264303|Drug|Desloratadine|5mg oral capsules, once daily, 4 week duration
16350209|NCT00264290|Drug|Valganciclovir|900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
16350210|NCT00264290|Drug|Placebo|Placebo designed to resemble Valganciclovir
16350211|NCT00264277|Drug|Vitamin K antagonist (Coumarin anticoagulants)|
16350212|NCT00264264|Procedure|Closure Device|
16350213|NCT00264264|Procedure|Direct Compression|
16350214|NCT00264251|Behavioral|Weight loss through diet and exercise|
16350215|NCT00264251|Drug|Rosiglitazone insulin sensitizing agent|
16350216|NCT00264238|Drug|Memantine|pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
16350217|NCT00264225|Drug|Lamaline® , 3 different doses, Dafalgan codeine|
16350218|NCT00264212|Drug|irbesartan and irbesartan-hydrochlorothiazide|
16350219|NCT00264199|Drug|GLP-1|iv. by weight (1.0 pmol/kg/min )
16350220|NCT00264199|Drug|placebo|same rate of infusion as GLP-1
16350221|NCT00264186|Drug|LPS 2 ng/kg intravenous (IV) bolus|
16350222|NCT00264186|Drug|rhSOD 82,000 IU (8.2 mg)/min intraarterially|
16350223|NCT00264186|Drug|Norepinephrine 60, 120, 240 pmol/min intraarterially over 5 min/dose level (two times; pre-dose and +3.5 hrs)|
16350224|NCT00264186|Drug|Acetylcholine 6.25, 12.5, 25 nmol/min intraarterially over 3 min/dose level (two times; pre-dose and +3.5 hrs)|
16350225|NCT00264186|Drug|Glyceroltrinitrate (nitroglycerine) 4, 8, 16 nmol/min over 3 min/dose level (two times; pre-dose and +3.5 hrs)|
16350226|NCT00264173|Drug|Valproate sodium|
16350227|NCT00264160|Drug|AMN107|
16350228|NCT00264147|Drug|etoricoxib|Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
16350229|NCT00264147|Drug|etoricoxib|Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
16350230|NCT00264147|Drug|etoricoxib|Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
16350231|NCT00264147|Drug|etoricoxib|Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
16350232|NCT00264147|Drug|Comparator: placebo|Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
16350233|NCT00264147|Drug|etoricoxib|Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
16350234|NCT00264147|Drug|Comparator: diclofenac|Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
16350235|NCT00264134|Drug|Docetaxel|
16350236|NCT00264134|Drug|Irinotecan|
16350237|NCT00264134|Drug|Carboplatin|
16350238|NCT00264108|Drug|Darbepoetin alfa|Either 150 ug once weekly or 500 ug once every 3 wks, variable treatment length.
16350239|NCT00264108|Drug|Epoetin alfa|40,000 IU once weekly, variable treatment length.
16350240|NCT00264095|Procedure|Oncological surgery|surgery is primary observed intervention and blood loss is between 500-3000 ml
16350241|NCT00264082|Drug|Zometa(drug)|
16350242|NCT00264069|Drug|antipsychotic|as prescribed
16350243|NCT00264069|Drug|antidepressants|as prescribed
16350244|NCT00264056|Device|hyperthermia|
16350245|NCT00264043|Device|emboli capturing guidewire device combined with stent|AngioGuard™ device and Bx Velocity™ stent
16350246|NCT00264030|Device|Angioguard distal protection device|PTCA with the Angioguard distal protection device.
16350247|NCT00264030|Other|PTCA|PTCA
16350248|NCT00264004|Drug|AZD2171|30 mg & 45 mg oral tablet
16350249|NCT00263991|Device|EEC-techniques|
16350250|NCT00263978|Drug|Defibrotide|
16350251|NCT00263965|Drug|Tesaglitazar|
16350252|NCT00263965|Drug|Metformin|
16350253|NCT00263965|Behavioral|Dietary and lifestyle modification counseling|
16350254|NCT00263952|Biological|bee venom|
16350255|NCT00263939|Behavioral|Homing in on Health|A peer (non-health professional) delivered intervention to enhance patient self-efficacy for chronic disease self-management. Developed as a modification of the Stanford Chronic Disease Self-Management Program.
16350256|NCT00263926|Biological|wasp venom|
16350257|NCT00263900|Device|RSV respi-strip and Quick-vue influenza|Assessments of 2 quick diagnostic tests in the emergency unit during children's care
16350258|NCT00263887|Drug|Alpha1-Proteinase Inhibitor (Human)|Weekly infusion of 60 mg/kg body weight for 2 years
16350259|NCT00263887|Drug|Albumin (Human) 20%, United States Pharmacopeia (USP)|Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.
16350260|NCT00263874|Drug|UK-500,001|
16350261|NCT00263861|Procedure|management of therapy complications|Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control.
16350262|NCT00263835|Behavioral|Empowerment|
16350263|NCT00263822|Drug|erlotinib hydrochloride|
16350264|NCT00263809|Device|Pathogen Reduction Technology|
16350265|NCT00263796|Drug|Oxytocin|10 international units = 1 cc, IV over 4 hours
16350266|NCT00263796|Drug|Placebo|Normal Saline, IV over 4 hours
16350268|NCT00263770|Device|soft palate implant|
16350269|NCT00263770|Other|Positive airway pressure (PAP)|which is air delivered by a mask worn over the nose during sleep
16350270|NCT00263757|Device|Adaptive Servo-Ventilation|Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.
16350271|NCT00263757|Other|Usual Care|Subjects randomized to this arm received medical management as prescribed by their cardiologist.
16350272|NCT00263744|Biological|MEDI 517|Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.
16350273|NCT00263744|Other|Aluminum hydroxide|Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
16350274|NCT00263731|Other|13-C-glucose|"10 grams of 13-C-glucose intravenously, as a 30-minute piggyback infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer."
16350275|NCT00263718|Drug|Calcipotriol plus betamethasone dipropionate (LEO 80185) gel|
16350276|NCT00263705|Drug|Adjuvant capecitabine|Capecitabine 2000 mg/m² daily six cycles
16350277|NCT00263705|Drug|capecitabine in aduvant setting|capecitabine in aduvant setting in ederly with breast cancer
16350278|NCT00263692|Biological|Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3|
16350279|NCT00263679|Biological|Prophylaxis: Diphtheria, tetanus and pertussis|
16350280|NCT00263666|Biological|Rotarix|Oral vaccination
16350281|NCT00263666|Biological|Placebo|Oral administration
16350282|NCT00263666|Biological|Tritanrix-HB+Hib|Concomitant routine vaccination, IM administration
16350283|NCT00263666|Biological|Polio Sabin|Oral administration, concomitant routine vaccination
16350284|NCT00263653|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
16350285|NCT00263640|Biological|Acaroid|The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
16350286|NCT00263640|Drug|Placebo|Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.
16350287|NCT00263627|Biological|Birch pollen allergoid|Subcutaneous injections were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.
16350288|NCT00263627|Other|Placebo|Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.
16350289|NCT00263601|Biological|Allergovit 6-grasses|Subcutaneous injections
16350290|NCT00263601|Other|Placebo|Subcutaneous injections
16350291|NCT00263588|Drug|lapatinib|tyrosine kinase inhibitor
16350292|NCT00263575|Drug|EN3267|EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
16350293|NCT00263562|Drug|Steroid arm|Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
16350294|NCT00263562|Other|Placebo|Patients received normal saline in lieu of intravenously-administered methylprednisolone and placebo pills equal in number to the steroid pills received in the steroid arm
16350295|NCT00263549|Biological|House dust mite Novo Helisen Depot|
16350296|NCT00263536|Procedure|Interpersonal Psychotherapy|
16350297|NCT00263523|Drug|[11C] (-)-RWAY|
16350298|NCT00263497|Device|Temporary tuber-ischii bearing prosthesis|Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment.
16350299|NCT00263484|Drug|dexamethasone|20 mg, PO (orally) on days 1-4, 8-11 and 15-18 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
16350300|NCT00263484|Drug|thalidomide|100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
16350301|NCT00263484|Drug|zoledronic acid|4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
16350302|NCT00263471|Drug|7-methylxanthine|
16350303|NCT00263458|Other|Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting|Eligible opioid-dependent HIV-infected patients are randomly assigned to receive buprenorphine opioid agonist treatment for 12 months either in an integrated HIV primary care setting (intervention group) versus a non-integrated substance use treatment clinic setting (comparison group).
16350304|NCT00263432|Procedure|Human allogenic chondrocytes|Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries
16350305|NCT00263419|Behavioral|Mindfulness Based Stress Reduction|8 weeks mindfulness based stress reduction (MBSR) based on body and meditation practices that aims at cultivation of openness, awareness of the present moment and acceptance of all internal and external experiences. It is assumed that this allows to act more reflectively rather than impulsively.
16350306|NCT00263406|Drug|Administration of an ACE-inhibitor or not|
16350307|NCT00263393|Drug|ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin|The first intervention was a clinical algorithm designed to enhance the identification and treatment of high-risk individuals compared to continued usual care. The algorithm was designed to be used by either physician or non-physician health care workers.
16350308|NCT00263393|Behavioral|Health Promotion|The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
16350309|NCT00263367|Other|Hyperbaric Oxygen|Hyperbaric Oxygen at 1.3 ATA for one hour
16350310|NCT00263354|Drug|Oxaliplatin|
16350370|NCT00262938|Other|educational intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
16350311|NCT00263341|Combination Product|NES/EE CVR|This is a Phase 3, multicenter, open-label study of a 21/7-day regimen of the 150/15 NES/EE CVR, in healthy women followed on an outpatient basis up to one year (13 cycles) of treatment over one year. Because of the stop treatment date of December 31, 2008 for all participants, women enrolling or re-enrolling in 2008 may not complete a full 13 cycles of treatment. Subjects may also participate in a 6 month follow-up period after the 300B study. The ring is designed to last for 12 months.
16350312|NCT00263328|Drug|Tacrolimus|Standard of care
16350313|NCT00263328|Drug|CP-690,550|CP-690,550 5 mg BID
16350314|NCT00263328|Drug|CP-690,550|CP-690,550 10 mg BID
16350315|NCT00263315|Drug|nebulised liposomal amphotericin B|
16350316|NCT00263302|Drug|dexamethasone|
16350317|NCT00263289|Procedure|preprocedural fasting|
16350318|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
16350319|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 5 mg, Once daily, 12 weeks.
16350320|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 10 mg, Once daily, 12 weeks.
16350321|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 20 mg, Once daily, 12 weeks.
16350322|NCT00263276|Drug|dapagliflozin|Tablets, Oral, 50 mg, Once daily, 12 weeks.
16350323|NCT00263276|Drug|placebo|Tablets, Oral, 0 mg, Once daily, 12 weeks.
16350324|NCT00263276|Drug|metformin|Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.
16350325|NCT00263263|Device|sirolimus-eluting stent|
16350326|NCT00263263|Device|bare metal stent|
16350327|NCT00263250|Procedure|watchful waiting or tension-free hernia repair|
16350328|NCT00263237|Drug|STA-5326|
16350329|NCT00263211|Drug|Plavix|
16350330|NCT00263211|Drug|Aspirin|
16350331|NCT00263198|Drug|PTK787/ZK222584|
16350332|NCT00263198|Drug|Letrozole|
16350333|NCT00263185|Dietary Supplement|Vitamin D|
16350334|NCT00263185|Dietary Supplement|Calcium carbonate|
16350335|NCT00263185|Drug|Vitamin D|
16350336|NCT00263185|Other|Placebo|
16350337|NCT00263172|Behavioral|behavior modification for weight loss|
16350338|NCT00263159|Procedure|Pharmaceutical care for asthma patients|
16350339|NCT00263146|Procedure|recruitment maneuver|
16350340|NCT00263133|Drug|Sertraline|
16350341|NCT00263120|Behavioral|Pain Questionnaire|
16350342|NCT00263107|Procedure|telerounding versus bedside rounding|
16350343|NCT00263094|Drug|Rofecoxib|
16350344|NCT00263081|Drug|Lapaquistat acetate and current lipid-lowering treatment|"Cohort 1: Weight is less than 50 kg:
~Lapaquistat acetate 50 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
~Cohort 2: Weight is more than 50 kg:
~Lapaquistat acetate 100 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks."
16350345|NCT00263081|Drug|Current lipid-lowering treatment|Lapaquistat acetate placebo-matching tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
16350346|NCT00263068|Drug|Rotigotine|"Transdermal Patch 1 per day for 24 hours containing:
~1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day"
16350347|NCT00263055|Drug|oxaliplatin|
16350348|NCT00263042|Drug|Rimonabant|Tablet, oral administration
16350349|NCT00263042|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16350350|NCT00263029|Drug|Oxaliplatin|60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
16350351|NCT00263029|Drug|Capecitabine|500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart
16350352|NCT00263029|Radiation|Radiotherapy|Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
16350353|NCT00263016|Drug|Docetaxel|
16350354|NCT00263003|Drug|Irbesartan/hydrochlorothiazide|
16350355|NCT00263003|Drug|Irbesartan|
16350356|NCT00262990|Drug|EPO906 (Patupilone)|
16350357|NCT00262990|Drug|doxorubicin|
16350358|NCT00262977|Behavioral|Electronic prompt plus patient-directed intervention|
16350359|NCT00262977|Behavioral|Electronic prompt to clinician to prescribe aspirin|
16350360|NCT00262964|Drug|Niacin|Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16.
16350361|NCT00262964|Drug|fenofibrate|Subjects randomized to fenofibrate will be treated with 200 mgs per day for eight weeks.
16350362|NCT00262964|Drug|placebo|Subjects randomized to placebo will be treated with one placebo pill per day for eight weeks.
16350363|NCT00262951|Biological|recombinant interferon alfa|administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1
16350364|NCT00262951|Drug|cisplatin|administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1
16350365|NCT00262951|Drug|fluorouracil|administered at a dose of 175 mg/m^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3
16350366|NCT00262951|Radiation|radiation therapy|5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).
16350367|NCT00262951|Procedure|Resection of tumor|After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.
16350368|NCT00262938|Behavioral|behavioral dietary intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
16350369|NCT00262938|Other|counseling intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
16350371|NCT00262938|Other|preventative dietary intervention|Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
16350372|NCT00262938|Procedure|quality-of-life assessment|Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
16350373|NCT00262925|Biological|alemtuzumab|Given subcutaneously
16350374|NCT00262925|Drug|asparaginase|Given IM
16350375|NCT00262925|Drug|methotrexate|Given IV or orally
16350376|NCT00262925|Drug|dexamethasone|Given orally
16350377|NCT00262925|Drug|leucovorin calcium|Given IV
16350378|NCT00262925|Drug|mercaptopurine|Given orally
16350379|NCT00262925|Drug|vincristine|Given IV
16350380|NCT00262899|Behavioral|counseling intervention|
16350381|NCT00262899|Other|educational intervention|
16350382|NCT00262899|Procedure|psychosocial assessment and care|
16350383|NCT00262886|Biological|anti-thymocyte globulin|
16350384|NCT00262886|Biological|graft-versus-tumor induction therapy|
16350385|NCT00262886|Biological|therapeutic allogeneic lymphocytes|
16350386|NCT00262886|Drug|cyclophosphamide|
16350387|NCT00262886|Drug|fludarabine phosphate|
16350388|NCT00262886|Drug|mycophenolate mofetil|
16350389|NCT00262886|Drug|tacrolimus|
16350390|NCT00262886|Procedure|allogeneic bone marrow transplantation|
16350391|NCT00262886|Procedure|peripheral blood stem cell transplantation|
16350392|NCT00262873|Drug|bortezomib|
16350393|NCT00262860|Drug|bortezomib|
16350394|NCT00262860|Drug|gemcitabine hydrochloride|
16350395|NCT00262847|Biological|Bevacizumab|Given IV
16350396|NCT00262847|Drug|Carboplatin|Given IV
16350397|NCT00262847|Other|Laboratory Biomarker Analysis|Correlative studies
16350398|NCT00262847|Drug|Paclitaxel|Given IV
16350399|NCT00262847|Other|Placebo|Given IV
16350400|NCT00262847|Other|Quality-of-Life Assessment|Ancillary studies
16350401|NCT00262834|Drug|vorinostat|Given orally, conventional surgery to follow.
16350402|NCT00262834|Other|conventional surgery|Undergo conventional surgery
16350403|NCT00262821|Drug|cisplatin|Given IV
16350404|NCT00262821|Drug|tirapazamine|Given IV
16350405|NCT00262808|Biological|sargramostim|
16350406|NCT00262808|Drug|fluorouracil|
16350407|NCT00262808|Drug|leucovorin calcium|
16350408|NCT00262808|Drug|oxaliplatin|
16350409|NCT00262808|Procedure|adjuvant therapy|
16350410|NCT00262808|Procedure|conventional surgery|
16350411|NCT00262808|Procedure|neoadjuvant therapy|
16350412|NCT00262795|Drug|Fludarabine|Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
16350413|NCT00262795|Drug|Chlorambucil|Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month
16350414|NCT00262782|Drug|Fludarabine|Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
16350415|NCT00262769|Drug|cisplatin|25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
16350416|NCT00262769|Drug|gemcitabine hydrochloride|1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
16350417|NCT00262743|Biological|Polyphenon E|"Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day
~Phase II: 2000 mg orally twice a day"
16350418|NCT00262730|Drug|poly ICLC|20 mcg/kg 3x each week (Maintenance cycles)
16350419|NCT00262730|Drug|temozolomide|daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
16350420|NCT00262730|Radiation|radiation therapy|RT: 60 Gy (6 weeks) concomitant therapy
16350421|NCT00262717|Device|HIV drug resistance tests based upon genotype testing|
16350422|NCT00262704|Behavioral|Simulated case-based customized learning|Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback
16350423|NCT00262704|Behavioral|Simulated case based customized learning + leader feedback|Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style
16350424|NCT00262678|Drug|EN3267|
16350425|NCT00262665|Drug|ORG 24448|flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
16350426|NCT00262665|Drug|Placebo|matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
16350427|NCT00262652|Drug|sodium pyruvate|
16350428|NCT00262639|Drug|Flumazenil and Gabapentin|2 mg flumazenil for infusion given slowly over 20 minutes given day 1 and day 2 gabapentin 300 mg increasing to 1200 mg over 4 days and continuing to day 30. Gabapentin 900 mg Day 31 to Day 33 gabapentin 600 mg Day 34 to 36 and gabapentin 300 mg Day 37 to 39.
16350429|NCT00262639|Drug|Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
16350430|NCT00262626|Drug|Intraocular pressure reduction|
16350431|NCT00262626|Procedure|Argon laser trabeculoplasty|
16350432|NCT00262626|Procedure|Trabeculectomy|
16350433|NCT00262613|Drug|sodium pyruvate in 0.9% sodium chloride solution|
16350434|NCT00262600|Drug|warfarin|once a day
16350435|NCT00262600|Drug|Dabigatran dose 1|twice daily
16350436|NCT00262600|Drug|Dabigatran dose 2|twice a day
16350437|NCT00262587|Drug|Seretide|Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)
16350438|NCT00262587|Drug|Placebo|Inhaled sugar powder in a placebo inhaler
16350439|NCT00262574|Drug|Nesiritide,|PCI
16350440|NCT00262561|Drug|Aspirin|The effect of Aspirin on platelet function was assessed.
16350441|NCT00262548|Drug|Rosuvastatin; improvement of lipid profile|
16350442|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD
16350800|NCT00259428|Drug|placebo|oral administration
16350443|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD
16350444|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
16350445|NCT00262522|Drug|lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)|LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD
16350446|NCT00262509|Device|Egress Badge|Egress Badge is worn by subjects who are asked to use the badge to exit the building. The badge indicates the direction of each exit sign on route to an exit.
16350447|NCT00262496|Drug|Botox|
16350448|NCT00262483|Drug|VX-950|
16350449|NCT00262483|Drug|ribavirin|
16350450|NCT00262483|Drug|peginterferon alfa-2a|
16350451|NCT00262470|Drug|Acetazolamide|250 mg PO x 1
16350452|NCT00262470|Drug|Atomoxetine|10-40 mg PO x 1 dose
16350453|NCT00262470|Other|NO Drug|No intervention - just monitoring
16350454|NCT00262470|Drug|Clonidine|Clonidine 0.05-0.3 mg PO x 1 dose
16350455|NCT00262470|Drug|Entacapone|Entacapone 200-400 mg PO x 1 dose
16350456|NCT00262470|Drug|Entacapone & Propranolol|Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
16350457|NCT00262470|Drug|Atomoxetine & Propranolol|Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
16350458|NCT00262470|Drug|Indomethacin|Indomethacin 25-50 mg PO x 1 dose
16350459|NCT00262470|Drug|Mecamylamine|mecamylamine 1.25-5 mg PO x 1 dose
16350460|NCT00262470|Drug|Isosorbide Dinitrate|Isosorbide dinitrate 5-20 mg PO x 1 dose
16350461|NCT00262470|Dietary Supplement|Melatonin|melatonin 3 mg PO x 1 dose
16350462|NCT00262470|Drug|Midodrine|midodrine 2.5-10 mg PO x 1 dose
16350463|NCT00262470|Drug|Modafinil|modafinil 100-200 mg PO x 1 dose
16350464|NCT00262470|Drug|Octreotide|octreotide 12.5-50 mcg Subcutaneous x 1 dose
16350465|NCT00262470|Radiation|Placebo|lactose tablet x 1 pill
16350466|NCT00262470|Drug|Propranolol|Propranolol 10-80 mg PO x 1-2 dose
16350467|NCT00262470|Drug|Modafinil & Propranolol|Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
16350468|NCT00262470|Drug|Sertraline|sertraline 25-50 mg PO x 1 dose
16350469|NCT00262470|Procedure|IV Saline|1 liter IV over 2 hours
16350470|NCT00262470|Other|Drinking Water|16 fluid ounces
16350471|NCT00262470|Device|Breathing Device|Breathing through a dead space tube
16350472|NCT00262470|Drug|memantine|memantine 5-20 mg PO x 1 dose
16350473|NCT00262470|Device|Abdominal binder|Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.
16350474|NCT00262457|Device|Implanted gluteal electrical stimulation system|Implanted electrical stimulation system incorporating BION microstimulators
16350475|NCT00262444|Procedure|Different turning frequencies|
16350476|NCT00262431|Procedure|Tracheostomy on day 3-5 in early group and 10-12 in late group|Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.
16350477|NCT00262418|Drug|Administration of ivermectin or permethrin|
16350478|NCT00262405|Drug|zileuton|
16350479|NCT00262405|Drug|azathioprine/prednisone|
16350480|NCT00262392|Drug|Pamidronate (AREDIA)|Pamidronate (AREDIA) vs radiation
16350481|NCT00262379|Drug|epoetin beta (NeoRecormon®)|• Prescription of the epoetin beta : when blood concentration of hemoglobin is lower or equal to 12 g/dL in male or lower or equal to 11 g/dL in female
16350482|NCT00262366|Device|Comparison of automatic CPAP versus fixed CPAP|
16350483|NCT00262353|Device|Dialysis with different artificial devices|
16350484|NCT00262340|Other|Non invasive measurement of airway inflammation|Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management
16350485|NCT00262327|Drug|Antangiogenesis|
16350486|NCT00262327|Genetic|endostatin gene|
16350487|NCT00262301|Drug|recombinant human C1 inhibitor|IV
16350488|NCT00262301|Drug|Placebo|IV
16350489|NCT00262288|Drug|i.v. recombinant human C1 inhibitor|
16350490|NCT00262275|Drug|Aspirin, Clopidogrel|
16350491|NCT00262262|Drug|Levetiracetam (drug)|The starting dose of levetiracetam was 500 mg/day and the dose was increased with 500 mg every other day to 6 tablets of 500 mg (Keppra, UCB, Belgium), divided into two doses daily corresponding to 3000 mg/day. The dose was kept at this level throughout the remaining treatment period - 4 weeks total. Six placebo tablets with identical appearance were dosed similarly to levetiracetam in the placebo phase.
16350492|NCT00262249|Drug|somatropin|
16350493|NCT00262236|Drug|Aliskiren|
16350494|NCT00262223|Behavioral|Seeking Safety|Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
16350495|NCT00262223|Drug|Sertraline|An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
16350496|NCT00262223|Drug|Pill placebo|
16350497|NCT00262210|Drug|Cyclophosphamide Epirubicin Etoposide Prednisolone|
16350498|NCT00262197|Behavioral|Customized Physician Intervention|
16350499|NCT00262197|Behavioral|Customized Patient Intervention|
16350500|NCT00262184|Drug|Soy Isoflavone|
16350501|NCT00262145|Drug|tea extracts|
16350502|NCT00262132|Drug|Mycophenolate|
16350503|NCT00262119|Device|Pacemaker Medtronic EnRhythm|Pacemaker specific programming
16350504|NCT00262106|Drug|PRO 2000/5|Gel
16350505|NCT00262106|Drug|Placebo|Placebo
16350506|NCT00262080|Drug|ecallantide|dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
16350507|NCT00262080|Drug|Phosphate Buffer Saline (PBS),|given as three 1mL subcutaneous injections.
16358625|NCT00191945|Drug|placebo|
16350508|NCT00262067|Drug|Bevacizumab|Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.
16350509|NCT00262067|Drug|Placebo|Placebo consisted of the vehicle for bevacizumab without the antibody.
16350510|NCT00262067|Drug|Chemotherapy|"The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles.
~Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle
~Docetaxel 75-100 mg/m^2 IV
~Paclitaxel protein-bound particles (Abraxane®) 260 mg/m^2 IV
~Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle
~5-fluorouracil 500 mg/m^2 IV + epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
~5-fluorouracil 500 mg/m^2 IV + doxorubicin 50 mg/m^2 IV + cyclophosphamide 500 mg/m^2 IV
~Doxorubicin 50-60 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
~Epirubicin 90-100 mg/m^2 IV + cyclophosphamide 500-600 mg/m^2 IV
~Capecitabine: 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle"
16350511|NCT00262054|Drug|Bivalirudin|bivalirudin to be administered as an intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.
16350512|NCT00262054|Drug|Un-fractionated heparin|UFH is given as an intravenous bolus of 140 units/kg followed by infusion of placebo 1.75 mg/kg per hour for the duration of the procedure.
16350513|NCT00262041|Biological|MenACWY-CRM conjugate vaccine, adjuvanted|
16350514|NCT00262041|Biological|MenACWY-CRM conjugate vaccine, unadjuvanted|
16350515|NCT00262041|Biological|MenACWY polysaccharide vaccine|
16350516|NCT00262028|Biological|MenACWY-CRM Vaccine|
16350517|NCT00262028|Biological|MenACWY-PS Vaccine|
16350518|NCT00262015|Biological|· Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)|
16350519|NCT00262002|Biological|MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)|MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
16350520|NCT00262002|Biological|MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)|MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
16350521|NCT00262002|Biological|MenACWY PS (MenACWY-CRM, polysaccharide vaccine)|MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
16350522|NCT00262002|Biological|HBV (Hepatitis B vaccine)|Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
16350523|NCT00262002|Biological|Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)|Prevnar was administered IM in the anterolateral area of the left thigh.
16350524|NCT00262002|Biological|MMR (Measles, Mumps and Rubella vaccine)|MMR at 12 month of age, administered in the left arm.
16350525|NCT00262002|Biological|DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)|DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
16350526|NCT00262002|Biological|Menjugate (Men C conjugated vaccine)|Menjugate was injected IM in the anterolateral area of the right thigh.
16350527|NCT00261976|Drug|Infliximab (Remicade)|This is an non-interventional study. Participants took the study product as part of their medical routine.
16350528|NCT00261963|Device|ultraviolet light|
16350529|NCT00261950|Drug|Sensipar (Cinacalcet HCl)|All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.
16350530|NCT00261937|Drug|Inhaled Furosemide vs Placebo (Normal Saline)|
16350531|NCT00261924|Device|Transfusion of Pathogen Inactivated Platelets stored for 6-7 days|pathogen inactivation of platelets for transfusion
16350532|NCT00261911|Drug|sibutramine|
16350533|NCT00261898|Procedure|Increase sleep|
16350534|NCT00261872|Drug|Methylphenidate|
16350535|NCT00261859|Behavioral|BNI|behavioral- brief intervention
16350536|NCT00261846|Drug|Bosutinib|"Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.
~Part 2, 500 mg oral, continuous, daily dosing."
16350537|NCT00261833|Biological|Alpha1-proteinase inhibitor|60 mg/kg body weight/week intravenous
16350538|NCT00261833|Other|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
16350539|NCT00261820|Drug|tacrolimus|
16350540|NCT00261820|Drug|mycophenolate mofetil|
16350541|NCT00261820|Drug|methylprednisolone|
16350542|NCT00261820|Drug|prednisolone|
16350543|NCT00261820|Drug|sirolimus|
16350544|NCT00261807|Drug|Daptomycin 6mg/kg/day|
16350545|NCT00261794|Behavioral|computer-assisted cognitive remediation (CACR)|36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom.
16350546|NCT00261794|Behavioral|manualized computer control condition (RC).|36 sessions of a manualized computer control condition.
16350547|NCT00261781|Behavioral|Treadmill training|Walking on a treadmill 3 times per week for 6 weeks
16350548|NCT00261768|Behavioral|Digital noise reduction|
16350549|NCT00261755|Procedure|Acupuncture|Based on international experiences and experiences from the pilot project 34 specified acupuncture points could be used.Treatment was individualised according to the woman's mobility and localization of pain. Needles were sterile stainless steel acupuncture needles in three lengths: 0.20 x 15 mm, 0.30 x 30 mm and 0.35 x 50 mm. No electric stimulation was used. The duration of needling could vary from 30 minutes to two hours and could be repeated. The needles were removed if the patient felt uncomfortable or in cases with obstetric pathology.
16350550|NCT00261755|Other|TENS|The Transcutaneous Electric Nerve Stimulation (TENS treatment) was carried out using a B.C - TENS 120Z unit. Two to four electrodes were placed on the skin of the lower back. The units were set in constant mode, initially with a pulse width of 60 micro-seconds and a pulse rate of 100 pulses per second. The treatment lasted from 20 to 45 minutes and could be repeated. The intensity of stimulation could be adjusted by the woman or the midwife.
16350551|NCT00261755|Other|Traditional Group|All analgesic methods available (Sterile water papules, nitro oxygen, bath tub, pethidine and epidural analgesics (EDA)). A specific analgesic was chosen by the woman and the midwife after informed choice.
16350552|NCT00261742|Drug|Penicillin versus cefuroxim per os|
16350553|NCT00261729|Drug|Paroxetine|paroxetine 20 mg
16350554|NCT00261729|Drug|Prazosin|Prazosin
16350555|NCT00261729|Drug|placebo|placebo capsules
16350556|NCT00261716|Behavioral|IPS|Individual Placement and Support Evidence based supported employment
16350557|NCT00261716|Behavioral|IE|Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
16350558|NCT00261716|Behavioral|VOMI|Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
16350559|NCT00261703|Drug|Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy|Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)
16350560|NCT00261703|Drug|Cisplatin, 5-fluorouracil (5-FU), radiotherapy|Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)
16350561|NCT00261703|Other|Cisplatin + radiotherapy|Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)
16350562|NCT00261690|Behavioral|Virtual Reality Distraction|Using virtual reality distraction during a procedure
16350563|NCT00261677|Drug|epoetin alfa|
16350564|NCT00261664|Device|telehomecare|
16350565|NCT00261625|Drug|alendronate|
16350566|NCT00261612|Drug|bortezomib|
16350567|NCT00261612|Drug|rituximab|
16350568|NCT00261612|Drug|dexamethasone|
16350569|NCT00261612|Procedure|treatment protocol|
16350570|NCT00261599|Drug|AQUAVAN® (fospropofol disodium) Injection|
16350571|NCT00261599|Drug|Midazolam HCI|
16350572|NCT00261586|Drug|aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib|
16350573|NCT00261573|Drug|galantamine hydrobromide|
16350574|NCT00261560|Drug|acetaminophen|
16350575|NCT00261547|Drug|Rituximab|All subjects will be treated with Rituximab 1000 mg (1 g) intravenously on days 1 and 15.
16350576|NCT00261521|Drug|epoetin alfa|
16350577|NCT00261508|Drug|risperidone|
16350578|NCT00261495|Drug|OROS hydromorphone HCl|8 to 32 mg once daily for 52 weeks (flexible dosing)
16350579|NCT00261495|Drug|Oxycodone|10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)
16350580|NCT00261482|Drug|norelgestromin + ethinyl estradiol|
16350581|NCT00261469|Drug|topiramate|
16350582|NCT00261456|Behavioral|PSA test|Patients tested for their level of Prostate Specific Antigen.
16350583|NCT00261456|Procedure|Prostate Biopsy|A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.
16350584|NCT00261443|Drug|Lithium or Valproate with placebo (PBO)|"Tablets, Oral, once daily
~lithium 250-2100 mg/day
~valproate 250-2500mg/day
~Placebo once daily"
16350585|NCT00261443|Drug|Lithium or Valproate with Aripiprazole|"Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
~lithium 250-2100 mg/day
~valproate 250-2500mg/day
~aripiprazole 15-30 mg/day"
16350586|NCT00261430|Behavioral|GAIN Acceptance Approach|
16350587|NCT00261417|Drug|Tesaglitazar|
16350588|NCT00261404|Drug|TNFerade™|
16350589|NCT00261391|Drug|Marimastat|
16350590|NCT00261378|Device|Transarterialchemoembolisation (TACE)|
16350591|NCT00261378|Device|DC Bead with Doxorubicin|
16350592|NCT00261365|Drug|Ipilimumab|Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
16350593|NCT00261365|Drug|Ipilimumab|Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
16350594|NCT00261352|Drug|Tesaglitazar|
16350595|NCT00261352|Drug|Metformin|
16350596|NCT00261352|Drug|Fenofibrate|
16350597|NCT00261339|Drug|Pantoprazole|
16350598|NCT00261326|Drug|simvastatin|80 mg once daily
16350599|NCT00261326|Drug|placebo|calcium tablets once daily
16350600|NCT00261313|Drug|Neulasta|6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy
16350601|NCT00261313|Drug|Aranesp|If Hb drops below 110, 300mcg Aranesp will be administered.
16350602|NCT00261300|Drug|Pantoprazole|Long term Pantoprozole trial
16350603|NCT00261287|Drug|Ciclesonide|
16350604|NCT00261274|Biological|A-ECO|
16350605|NCT00261274|Biological|Saline|
16350606|NCT00261261|Behavioral|ADVANCE|
16350607|NCT00261261|Drug|Midazolam|
16350608|NCT00261261|Procedure|Parental presence|
16350609|NCT00261248|Biological|Immunization with inactivated bacteria|
16350610|NCT00261235|Behavioral|Supported Employment|
16350611|NCT00261235|Behavioral|Using Strengths in Employment System (USES)|
16350612|NCT00261222|Drug|Amodiaquine|
16350613|NCT00261209|Drug|Collagenase|Collagenase injection into adhesion restricting tendon gliding
16350614|NCT00261209|Drug|Collagenase injection|injection of collagenase into adhesion restricting tendon gliding
16350615|NCT00261196|Drug|Collagenase|Anterior shoulder capsule injection
16350616|NCT00261183|Drug|Melatonin|
16350617|NCT00261170|Drug|bupropion|150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
16350618|NCT00261170|Other|placebo|1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
16350619|NCT00261157|Device|InTouch Telerounding Robot|
16350620|NCT00261144|Drug|Collagenase|One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)
16350621|NCT00261144|Biological|Biological|Collagenase injection
16350622|NCT00261131|Drug|Botulinum Toxin A|
16350623|NCT00261118|Drug|Rituximab|Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline
16350624|NCT00261105|Drug|telithromycin|
16350625|NCT00261092|Drug|Oxaliplatin|
16350626|NCT00261079|Drug|Fexofenadine|
16350627|NCT00261053|Drug|i.v. recombinant human C1 inhibitor|
16350628|NCT00261040|Procedure|Minimally Invasive Surgery|In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
16350629|NCT00261040|Procedure|Standard Surgery|The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.
16350630|NCT00261027|Drug|Exemestane|
16350631|NCT00261001|Biological|Transcutaneous mode of administration|
16350632|NCT00261001|Biological|Intramuscular mode of administration|
16350633|NCT00260988|Drug|Fragmin (dalteparin)|200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
16350634|NCT00260988|Drug|Innohep (tinzaparin)|175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery
16350635|NCT00260962|Drug|Olanzapine|After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
16350636|NCT00260962|Behavioral|Day Hospital|Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
16350637|NCT00260949|Procedure|Arthroscopic repair of rotator cuff tear|Patients will undergo arthroscopic shoulder surgery in the standard fashion
16350638|NCT00260923|Drug|aliskiren|
16350639|NCT00260884|Behavioral|conventional gastrectomy or radical lymph node dissection|
16350640|NCT00260858|Drug|Test Meal: Reference food (glucose or white bread)|
16350641|NCT00260858|Drug|Test Meal: Pirate's Booty|
16350642|NCT00260858|Drug|Test Meal: Ceaprove wafer|
16350643|NCT00260858|Drug|Test Meal: Stretch Island Strawberry Fruit Leather|
16350644|NCT00260832|Drug|Cytarabine or Supportive Care|Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
16350645|NCT00260832|Drug|Dacogen (decitabine) only|20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
16350646|NCT00260819|Drug|Bosentan|Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
16350647|NCT00260819|Drug|Bosentam TRACLEER|Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
16350648|NCT00260793|Drug|Ropinirole Hydrochloride|
16350649|NCT00260780|Behavioral|The MISTERS Intervention for Post Jail Release Men|
16350650|NCT00260767|Drug|HEC placebo gel|
16350651|NCT00260754|Behavioral|Community-Popular Opinion Leader Model|
16350652|NCT00260754|Behavioral|Diffusion of Innovations|
16350653|NCT00260741|Drug|Smoked Cannabis|
16350654|NCT00260728|Device|vascular access graft implantation|vascular access graft implantation
16350655|NCT00260715|Behavioral|Community-Popular Opinion Leader Model|
16350656|NCT00260715|Behavioral|Diffusion of Innovations|
16350657|NCT00260702|Drug|Omalizumab (Xolair)|
16350658|NCT00260689|Biological|Anti-thymocyte globulin (rabbit)|
16350659|NCT00260689|Biological|Anti-thymocyte globulin (horse)|
16350660|NCT00260689|Drug|Cyclosporine|
16350661|NCT00260689|Drug|Alemtuzumab|
16350662|NCT00260676|Procedure|change ventilation|reduction of tidal volume, increase of PEEP, recruiting maneuver, apnea test during CPAP
16350663|NCT00260663|Procedure|Group hearing aid fittings|
16350664|NCT00260663|Procedure|Group hearing aid follow-up|
16350665|NCT00260650|Behavioral|Heart PACT Program|patient activation intervention
16350666|NCT00260637|Procedure|Acupuncture|
16350667|NCT00260624|Drug|Escitalopram (Lexapro)|
16350668|NCT00260611|Drug|Oxaliplatin|
16350669|NCT00260611|Drug|Taxotere|
16350670|NCT00260598|Procedure|LIFE Bronchoscopy|The first LIFE Bronchoscopy is performed at least 6 months following surgical resection of primary NSCLC. Timing of subsequent bronchoscopies is dependent on pathology from first bronchoscopy.
16350671|NCT00260585|Procedure|Survey of client health, personal habits, family history|A questionnaire is administered at the time of consent.
16350672|NCT00260585|Procedure|Blood specimen for non-DNA and DNA parts|Blood specimen is collected prior to surgery or at the time of scheduled routine surgical procedure(s), and at the time of routine follow-up visits
16350673|NCT00260585|Procedure|Biopsy of esophageal/stomach tissue, lymph nodes, tumor|Tissue from the biopsies is collected intraoperatively.
16350674|NCT00260585|Procedure|Biopsies from routine clinical surveillance endoscopies|Tissue from the biopsies is collected intraoperatively.
16350675|NCT00260572|Behavioral|Questionnaires to evaluate QOL|Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
16350676|NCT00260572|Behavioral|Questionnaires to evaluate heartburn and quality of life|Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
16350677|NCT00260572|Behavioral|Questionnaire to evaluate satisfaction with treatment|Questionnaire administered postoperatively at set intervals.
16350678|NCT00260572|Behavioral|Questionnaire to evaluate presence or absence of pain|Questionnaire administered preoperatively and at set intervals postoperatively.
16350801|NCT00259415|Behavioral|Caregiver support via telephone|
16358626|NCT00191932|Drug|Duloxetine|
16350679|NCT00260559|Procedure|Questionnaires|Quality of life and heartburn assessment questionnaires are administered preoperatively and at set intervals postoperatively.
16350680|NCT00260546|Procedure|AV-node ablation|Patients that are randomized to AV node ablation will have their AV-node ablated using a transfemoral approach. Concurrently,a back-up pacing lead will temporarily be placed in the right ventricle.
16350681|NCT00260533|Drug|atomoxetine|Flexible dose, up to 50 mg per day
16350682|NCT00260533|Drug|placebo|placebo (matching to atomoxetine)
16350683|NCT00260520|Drug|Dalteparin|
16350684|NCT00260494|Other|acupuncture|standardized acupuncture intended to improve blood flow and reduce edema to lower extremity.
16350685|NCT00260494|Other|sham acupuncture|standardized sham acupuncture at same sites as acupuncture.
16350686|NCT00260481|Drug|Prometa|Medication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days
16350687|NCT00260481|Drug|Placebo|Placebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.
16350688|NCT00260468|Other|Clinical examination program|Psychiatric/clinical interview MRI scan Blood samples Saliva samples Eye examination
16350689|NCT00260442|Behavioral|Resistance Training|12 weeks, 3 times a week whole body resistance training
16350690|NCT00260442|Behavioral|Sedentary|Absence of physical activity
16350691|NCT00260429|Biological|collagenase clostridium histolyticum|Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
16350692|NCT00260416|Procedure|Primary angioplasty with stent and abciximab|
16350693|NCT00260403|Procedure|Photodynamic therapy versus Transpupillary thermotherapy|
16350694|NCT00260390|Drug|Testoviron|
16350695|NCT00260377|Procedure|Coronary artery bypass surgery|
16350696|NCT00260364|Drug|Gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycle|
16350697|NCT00260364|Drug|Capecitabine orally days 1 -21|
16350698|NCT00260364|Drug|Erlotinib 100 mg orally days 1-28|
16350699|NCT00260364|Drug|Bevacizumab 5 mg/kg intravenously every 2 weeks|
16350700|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.1 mL, ID (TRC regimen)
16350701|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.5 mL, IM (ZAGREB regimen)
16350702|NCT00260351|Biological|Purified Verocell Rabies Vaccine|0.5 mL, IM (ESSEN regimen)
16350703|NCT00260338|Biological|stem cell|mesenchymal stromal cell
16350704|NCT00260325|Drug|valdecoxib|
16350705|NCT00260312|Biological|Inactivated Polio Vaccine given at an accelerated schedule|
16350706|NCT00260286|Behavioral|Energy availability|
16350707|NCT00260273|Behavioral|Cognitive Behaviour Therapy|therapy
16350708|NCT00260260|Drug|Oxycodone|
16350709|NCT00260247|Drug|carbamazepine oxcarbazepine|
16350710|NCT00260234|Biological|Allogeneic Cultured Islet Cells (human); Encapsulated|
16350711|NCT00260221|Behavioral|using VR hypnosis/distraction and audio hypnosis|a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
16350712|NCT00260208|Drug|Cyclosporine A|Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation.
16350713|NCT00260208|Drug|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses either orally or via a nasogastric (NG) tube or intravenously (i.v).
16350714|NCT00260195|Behavioral|School-based cognitive behavioral support group|
16350715|NCT00260169|Behavioral|Collaborative care treatment|Patients receiving collaborative care treatment choose 12 weeks of CBT and/or medication management (antidepressants prescribed by patients' primary care provider) from the study depression care specialist (DCS).
16350716|NCT00260169|Behavioral|Enhanced usual care|Usual care participants are assigned to a 16-week wait-list for the study treatment, during which they are free to receive treatment elsewhere. A letter is given to participants' primary care providers (PCP) that indicates they screened positive for depression. In addition, patients receive an information booklet about depression and a community resource list.
16350717|NCT00260156|Drug|vildagliptin|
16350718|NCT00260156|Drug|placebo|
16350719|NCT00260143|Drug|Testosterone enanthate|
16350720|NCT00260143|Drug|Placebo|
16350721|NCT00260130|Other|food in fluid form|dietary intake of fluid forms of vegetables
16350722|NCT00260130|Other|food in solid form|dietary intake of solid forms of vegetables
16350723|NCT00260117|Behavioral|Exercise|Referal to a website
16350724|NCT00260091|Procedure|intrauterine insemination|An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.
16350725|NCT00260091|Procedure|infertility|This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.
16350726|NCT00260078|Drug|Atazanavir|200 mg to 400 mg orally daily
16350727|NCT00260078|Drug|Darunavir|300 mg or 600 mg orally twice daily
16350728|NCT00260078|Drug|Efavirenz|Dosage dependent on participant
16350729|NCT00260078|Drug|Nevirapine|Dosage dependent on participant
16350730|NCT00260078|Drug|Ritonavir|50 mg or 100 mg orally twice daily
16350731|NCT00260078|Drug|Tenofovir disoproxil fumarate|300 mg orally daily
16350732|NCT00260078|Procedure|Pharmacokinetic Study|Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
16350733|NCT00260065|Drug|Decitabine|20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
16350734|NCT00260052|Drug|Erythropoietin administration|
16350735|NCT00260039|Biological|Comparator: Gardasil|0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
16350736|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 1|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
16350926|NCT00258388|Drug|prednisone|5mg PO BID
16350927|NCT00258375|Drug|custirsen sodium|
16350928|NCT00258375|Drug|docetaxel|
16350737|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 2|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
16350738|NCT00260039|Biological|Comparator: octavalent HPV Vaccine - dose formulation 3|0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
16350739|NCT00260026|Drug|Docetaxel|
16350740|NCT00260026|Drug|Jin Fu Kang|
16350741|NCT00260013|Procedure|program of care delivery|
16350742|NCT00260000|Drug|5,6,7,8-tetrahydrobiopterin|
16350743|NCT00259987|Drug|Lapatinib (GW572016) oral tablets|
16350744|NCT00259974|Drug|Rituximab|Rituximab
16350745|NCT00259961|Procedure|open fundoplication|
16350746|NCT00259961|Procedure|laparoscopic fundopliaction|
16350747|NCT00259948|Procedure|Aerobic exercise training|
16350748|NCT00259935|Drug|topotecan|topotecan
16350749|NCT00259922|Drug|Placebo|Placebo
16350750|NCT00259922|Drug|Alvimopan|0.5 mg QD
16350751|NCT00259922|Drug|Alviompan|0.5 mg BID
16350752|NCT00259909|Other|GSK questionnaire|GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.
16350753|NCT00259909|Other|St. George's Respiratory Questionnaire|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.
16350754|NCT00259909|Other|Acute Short Form 12 version 2|The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health
16350755|NCT00259909|Other|Global Efficacy questionnaire|Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
16350756|NCT00259896|Drug|exenatide|
16350757|NCT00259883|Drug|paroxetine|1 or 2 tablets once a day
16350758|NCT00259870|Drug|SB-773812|
16350759|NCT00259870|Drug|Olanzapine|
16350760|NCT00259857|Drug|Alendronate|Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
16350761|NCT00259844|Biological|TroVax|
16350762|NCT00259831|Drug|CVT-E002 (Cold-FX); a natural health product|
16350763|NCT00259818|Drug|EM-1421|
16350764|NCT00259805|Drug|Rituximab|375 mg/m2 given as an IV infusion once weekly for four doses
16350765|NCT00259792|Drug|Budesonide/formoterol Turbuhaler|
16350766|NCT00259779|Drug|budesonide/formoterol|
16350767|NCT00259779|Drug|Prednisolone|
16350768|NCT00259766|Drug|Budesonide|
16350769|NCT00259766|Drug|Formoterol|
16350770|NCT00259766|Drug|Terbutaline|
16350771|NCT00259753|Drug|Bevasiranib|
16350772|NCT00259740|Drug|DENOSUMAB|120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.
16350773|NCT00259714|Drug|dialysate sodium individualization|"Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium (individualized)."
16350774|NCT00259714|Drug|standard dialysate sodium|The prescribed dialysate sodium is 140 mEq/L
16350775|NCT00259701|Device|Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin|
16350776|NCT00259688|Device|CPAP therapy for subjects diagnosed with sleep apnea|CPAP therapy is being offered to women who are diagnosed on Polysomnogram with sleep apnea. However, this is not an intervention study and treatment is not part of the study protocol.
16350777|NCT00259675|Drug|carboplatin/gemcitabine, carboplatin/taxol|
16350778|NCT00259662|Drug|atorvastatin|
16350779|NCT00259649|Drug|eletriptan|oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
16350780|NCT00259636|Drug|zonisamide|zonisamide 100 mg -300 mg daily vs placebo
16350781|NCT00259623|Device|Radiofrequency ablation|
16350782|NCT00259610|Drug|methotrexate|varies
16350783|NCT00259610|Drug|sulfasalazine|varies
16350784|NCT00259610|Drug|hydroxychloroquine|varies
16350785|NCT00259610|Drug|etanercept|varies
16350786|NCT00259597|Procedure|breast ductal lavage|breast ductal lavage and nipple aspiration done once
16350787|NCT00259584|Behavioral|Management and Outcome of SVCO|
16350788|NCT00259571|Drug|retarded release phosphatidylcholine|2g daily, given orally QTD
16350789|NCT00259558|Drug|retarded release phosphatidylcholine|
16350790|NCT00259545|Drug|Retarded Release Phosphatidylcholine (rPC)|
16350791|NCT00259532|Procedure|Ultrasound and contrast agent|contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas
16350792|NCT00259519|Procedure|Induction of delivery|Induction of delivery
16350793|NCT00259506|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|
16350794|NCT00259493|Procedure|Off-Pump Coronary Artery Bypass Graft Surgery|
16350795|NCT00259480|Behavioral|Home Based Intervention|occupational therapy
16350796|NCT00259467|Behavioral|Home-Based Behavorial Intervention|
16350797|NCT00259454|Behavioral|In-home intervention|occupational therapy techniques to reduce caregiver stress
16350798|NCT00259441|Drug|Simvastatin|
16350799|NCT00259428|Drug|Dronedarone (SR33589)|oral administration
16350802|NCT00259402|Drug|Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)|OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
16350803|NCT00259389|Behavioral|Directly observed therapy (DOT)|
16350804|NCT00259376|Drug|Dronedarone (SR33589)|oral administration
16350805|NCT00259376|Drug|placebo|oral administration
16350806|NCT00259363|Drug|Oxaliplatin|oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
16350807|NCT00259350|Drug|Skin disinfection|
16350808|NCT00259337|Biological|Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine|0.5 mL, IM
16350809|NCT00259324|Behavioral|Diet and Activity|Diet and Activity
16350810|NCT00259311|Drug|LY2422347|
16350811|NCT00259311|Drug|placebo|
16350812|NCT00259298|Drug|teriparatide|Subcutaneous, 20 microgram (mcg)/day, 18 months
16350813|NCT00259285|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
16350814|NCT00259285|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 3 cycles
16350815|NCT00259272|Drug|olanzapine|5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
16350816|NCT00259259|Behavioral|SALATRIM|
16350817|NCT00259246|Drug|Peptide YY infusion|
16350818|NCT00259233|Drug|peripheral Peptide YY administration|
16350819|NCT00259220|Drug|erythomycin|erythomycin
16350820|NCT00259220|Procedure|gastric lavage alone|gastric lavage alone
16350821|NCT00259220|Procedure|erythromycine and gastric lavage|erythromycine and gastric lavage
16350822|NCT00259207|Procedure|Pulmonary valve insertion|Pulmonary valve insertion
16350823|NCT00259207|Procedure|medical surgery hybride|medical surgery hybride
16350824|NCT00259194|Behavioral|Moving|The patients are allowed to lift their head, arms and legs during the 2 hours.
16350825|NCT00259194|Behavioral|No Moving|The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours.
16350826|NCT00259181|Procedure|saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation|
16350827|NCT00259168|Drug|Nateglinide|
16350828|NCT00259155|Drug|Rifaximin|
16350829|NCT00259142|Drug|Chloroquine, sulphadoxine-pyrimethamine|
16350830|NCT00259129|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)
16350831|NCT00259116|Drug|Relaxin|
16350832|NCT00259103|Drug|Serelaxin|
16350833|NCT00259103|Drug|Placebo|
16350834|NCT00259090|Drug|Fulvestrant|500 mg intramuscular injection
16350835|NCT00259090|Drug|Anastrazole|oral tablet
16350836|NCT00259077|Drug|Omeprazole|
16350837|NCT00259064|Drug|Gefitinib|
16350838|NCT00259064|Other|Placebo|
16350839|NCT00259051|Drug|Omeprazole|
16350840|NCT00259038|Drug|Carperitide|
16350841|NCT00259038|Drug|Placebo|
16350842|NCT00259025|Drug|lipid emulsion with a high content of n-3 fatty acids|
16350843|NCT00259012|Drug|pantoprazole sodium enteric-coated spheroid suspension|pediatric suspension taken daily x 7 days
16350844|NCT00258999|Device|Skin Cholesterol Testing|
16350845|NCT00258986|Procedure|Living donornephrectomy|
16350846|NCT00258973|Procedure|Carotid Ultrasound performed in office practice|
16350847|NCT00258960|Drug|Liposomal Doxorubicin|
16350848|NCT00258960|Drug|Cyclophosphamide|
16350849|NCT00258960|Drug|Trastuzumab|
16350850|NCT00258947|Biological|Smallpox vaccine, LISTER strain, from chick embryo cells|
16350851|NCT00258934|Biological|Inactivated, split-virion influenza vaccine|0.1 mL single annual dose
16350852|NCT00258934|Biological|Inactivated, split-virion, influenza virus|0.5 mL single annual dose
16350853|NCT00258908|Biological|Diphteria, tetanus, and Acellular Pertussis vaccine|0.5 mL, Intramuscular
16350854|NCT00258895|Biological|DAPTACEL®: DTaP|0.5 mL, Intramuscular
16350855|NCT00258895|Biological|DAPTACEL®: DTaP|0.5 mL, Intramuscular
16350856|NCT00258882|Biological|Tetanus Toxoid, acellular pertussis, diphtheria toxoid|0.5 mL, Intramuscular
16350857|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
16350858|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
16350859|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
16350860|NCT00258856|Biological|Polysaccharide Diphtheria Conjugate Vaccine|0.5 mL, Intramuscular
16350861|NCT00258843|Biological|Inactivated Poliomyelitis vaccine|0.5 mL, intramuscular (IM)
16350862|NCT00258843|Biological|Inactivated Poliomyelitis vaccine|0.5 mL, IM
16350863|NCT00258830|Biological|Fluzone®: Influenza Virus Vaccine|0.5 mL, Intramuscular
16350864|NCT00258830|Biological|Fluzone®: Influenza Virus Vaccine|0.5 mL, Intramuscular
16350865|NCT00258817|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (Day 0 and Day 28)
16350866|NCT00258817|Biological|Influenza Virus Vaccine (Fluzone®)|0.25 mL, Intramuscular (Day 0)
16350867|NCT00258804|Drug|Insulin glargine|
16350868|NCT00258791|Drug|Ibuprofen|
16350869|NCT00258778|Drug|Human Glucocerebrosidase (prGCD)|
16350870|NCT00258765|Drug|Zoledronic Acid|
16350871|NCT00258765|Drug|Docetaxel|
16350872|NCT00258752|Behavioral|IPT-AST|IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.
16350873|NCT00258752|Other|Enhanced IPT-AST|Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
16350874|NCT00258752|Other|School counseling|Usual care consists of standard treatments, including individual counseling with guidance counselor.
16350875|NCT00258739|Drug|Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine|Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
16350924|NCT00258388|Drug|custirsen sodium|"640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle)
~Subsequent cycles:
~weekly on days 1, 8, 15 (3 week cycles)"
16350925|NCT00258388|Drug|docetaxel|75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)
16350876|NCT00258739|Other|Docetaxel + gemcitabine + carboplatin + radiotherapy|Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
16350877|NCT00258726|Biological|MMR-II|
16350878|NCT00258726|Biological|Pro-Quad|
16350879|NCT00258726|Biological|Varivax|
16350880|NCT00258713|Drug|voclosporin|voclosporin 0.2, 0.3, or 0.4 mg/kg BID
16350881|NCT00258700|Biological|Haemophilus influenzae type b- and meningococcal (vaccine)|
16350882|NCT00258687|Biological|GVAX|4 vaccines every two weeks
16350883|NCT00258674|Other|Medicare Claims Feedback|Physician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients.
16350884|NCT00258674|Other|Medical Record Review|Physician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study.
16350885|NCT00258674|Other|Diabetes Resource Nurse|Diabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource.
16350886|NCT00258661|Procedure|Osteopathic Manipulative Treatment|In addition to conventional treatment for pneumonia, a 10-minute standardized OMT protocol + 5-minute nonstandardized component was performed twice daily for the duration of hospitalization.
16350887|NCT00258661|Procedure|Light-touch Treatment|In addition to conventional treatment for pneumonia, a 10-minute standardized light-touch protocol (designed to mimic OMT standardized protocol) + 5-minute auscultation of carotid bruits, heart, and lungs was performed twice daily for the duration of hospitalization.
16350888|NCT00258635|Biological|RagweedMATAMPL|
16350889|NCT00258622|Drug|NS1209|
16350890|NCT00258622|Drug|Lidocaine|
16350891|NCT00258609|Drug|Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection|
16350892|NCT00258596|Device|sirolimus-eluting stent|
16350893|NCT00258557|Drug|LPV/RTV|400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
16350894|NCT00258557|Drug|TMC-114/RTV|two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
16350895|NCT00258531|Device|Olympus ScopeGuide®, 3-dimentional magnetic imager|
16350896|NCT00258518|Procedure|mechanical ventilation/CT Scan|evaluation of pleural effusion and respiratory mechanics, CT scan
16350897|NCT00258505|Procedure|Procedure: intracranial monitoring up to 9 days after injury|
16350898|NCT00258492|Behavioral|Aerobic exercise|
16350899|NCT00258479|Drug|ModafinilNicotine Replacement Therapy|A dose escalation design includes eight dose conditions across a 12-day study (nicotine low-high, modafinil low-high and 4 combinations). After day 1 placebo dose, placebo sessions occur in random order during low dose, high dose, and dose-combination testing. Modafinil and nicotine are tested alone with subjects exposed to low active doses prior to higher doses. Dose interactions will be determined with low doses tested in combination followed by low-high dose combinations then high-high dose combination. Doses are administered under double-blind, double dummy procedures. A nicotine patch (0, 7 or 14 mg doses) is applied at 7 am. Modafinil doses are prepared in size 00 opaque capsules. The modafinil dose (0, 100, 200 mg) is administered at 5 PM.
16350900|NCT00258479|Drug|Modafinil|See Modafinil Intervention Description above.
16350901|NCT00258466|Radiation|radiation therapy|
16350902|NCT00258453|Other|metabolic assessment|
16350903|NCT00258453|Other|physiologic testing|
16350904|NCT00258453|Procedure|biopsy|
16350905|NCT00258453|Procedure|computed tomography|
16350906|NCT00258453|Procedure|conventional surgery|
16350907|NCT00258453|Procedure|magnetic resonance imaging|
16350908|NCT00258453|Procedure|management of therapy complications|
16350909|NCT00258453|Procedure|psychosocial assessment and care|
16350910|NCT00258453|Procedure|quality-of-life assessment|
16350911|NCT00258453|Radiation|radiation therapy|
16350912|NCT00258440|Drug|Weekly procrit dosing|The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week.
16350913|NCT00258440|Drug|Interval Dosing|The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.
16350914|NCT00258427|Biological|anti-thymocyte globulin|Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
16350915|NCT00258427|Biological|filgrastim|given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
16350916|NCT00258427|Drug|busulfan|Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
16350917|NCT00258427|Drug|cyclophosphamide|10 mg/kg intravenously (IV) on Days -5 through -2.
16350918|NCT00258427|Drug|fludarabine phosphate|35 mg/m^2 intravenously (IV) on Days -5 through -2.
16350919|NCT00258427|Drug|methylprednisolone|1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
16350920|NCT00258427|Biological|Hematopoietic stem cell transplantation|Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
16350921|NCT00258401|Dietary Supplement|dietary intervention|At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.
16350922|NCT00258401|Procedure|management of therapy complications|Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
16350923|NCT00258401|Procedure|quality-of-life assessment|Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
16358706|NCT00191399|Drug|Fluoxetine|
16350929|NCT00258362|Drug|carboplatin|Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
16350930|NCT00258362|Drug|docetaxel|75 mg/m^2 on Day 1 of each course
16350931|NCT00258362|Radiation|radiation therapy|Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
16350932|NCT00258349|Drug|vorinostat|Given orally
16350933|NCT00258349|Drug|trastuzumab|Given IV
16350934|NCT00258336|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16350935|NCT00258336|Biological|rituximab|
16350936|NCT00258336|Biological|sargramostim|
16350937|NCT00258323|Drug|cisplatin|20mg/m2d/IV continuous infusion x days
16350938|NCT00258323|Drug|fluorouracil|1000mg/m2/d IV continuous infusion x 4 days
16350939|NCT00258323|Drug|Iressa|250mg po qd days 1-28 then x 2 years
16350940|NCT00258323|Procedure|conventional surgery|conventional surgery
16350941|NCT00258323|Radiation|radiation therapy|150 cGy bid
16350942|NCT00258310|Drug|capecitabine|Capecitabine 1000mg/day for one year
16350943|NCT00258310|Procedure|Surgery, chemotherapy and/or radiotherapy|Surgery, chemotherapy and/or radiotherapy
16350944|NCT00258297|Drug|gefitinib|
16350945|NCT00258297|Procedure|conventional surgery|
16350946|NCT00258297|Procedure|enzyme inhibitor therapy|
16350947|NCT00258297|Procedure|neoadjuvant therapy|
16350948|NCT00258297|Procedure|protein tyrosine kinase inhibitor therapy|
16350949|NCT00258297|Procedure|surgery|
16350950|NCT00258284|Drug|capecitabine|Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
16350951|NCT00258284|Drug|docetaxel|Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
16350952|NCT00258271|Biological|filgrastim|
16350953|NCT00258271|Drug|cladribine|
16350954|NCT00258271|Drug|cytarabine|
16350955|NCT00258271|Drug|imatinib mesylate|
16350956|NCT00258258|Drug|paricalcitol|
16350957|NCT00258258|Drug|zoledronic acid|
16350958|NCT00258245|Dietary Supplement|ascorbic acid|Ascorbic Acid (Vit C)- 1000 mg IVPB after Arsenic Trioxide [ATO] days 1, 4, 8, 11
16350959|NCT00258245|Drug|arsenic trioxide|Arsenic Trioxide (Trisenox)- 0.10→0.15→0.25 mg/kg/dose IVPB days 1, 4, 8, 11
16350960|NCT00258245|Drug|bortezomib|Bortezomib (Velcade)- 0.7→1.0 mg/m2 IVP days 1, 4, 8, 11
16350961|NCT00258245|Drug|dexamethasone|Dexamethasone (Decadron)- 40 mg/days IVPB or PO d 1, 4, 8, 11
16350962|NCT00258245|Drug|thalidomide|Thalidomide (Thalomid) - 50 mg/day by mouth (PO)
16350963|NCT00258245|Drug|Aspirin|Aspirin - 325 mg by mouth (PO) every day
16350964|NCT00258232|Drug|capecitabine|
16350965|NCT00258232|Drug|celecoxib|
16350966|NCT00258232|Drug|irinotecan hydrochloride|
16350967|NCT00258206|Biological|rituximab|
16350968|NCT00258206|Drug|cyclophosphamide|
16350969|NCT00258193|Drug|MD-1100 Acetate|
16350970|NCT00258180|Biological|filgrastim|Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
16350971|NCT00258180|Drug|cyclophosphamide|Administered IV over 1 hour on days 1-4
16350972|NCT00258167|Behavioral|"filling the Experience of Caregiving Inventory"|8 weeks of group therapy for family members
16350973|NCT00258154|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
16350974|NCT00258154|Biological|Comparator: placebo|3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
16350975|NCT00258154|Biological|Comparator: Infanrix(tm) Hexa|3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
16350976|NCT00258141|Drug|Rupatadine|
16350977|NCT00258141|Drug|Placebo|
16350978|NCT00258128|Drug|Salsalate|Active
16350979|NCT00258128|Drug|Placebo|Placebo for salslate, used only in the third trial
16350980|NCT00258115|Drug|salsalate|
16350981|NCT00258102|Drug|Levofloxacin|
16350982|NCT00258089|Drug|Levofloxacin|
16350983|NCT00258076|Drug|EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE|
16350984|NCT00258063|Drug|EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets).|
16350985|NCT00258050|Drug|Midazolam|Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.
16350986|NCT00258050|Drug|Lapatinib|Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.
16350987|NCT00258037|Behavioral|Pelvic Floor Muscle training|
16350988|NCT00258024|Drug|IPT-sulphadoxinepyrimethamine|
16350989|NCT00258011|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|0.58 mg/kg every week
16350990|NCT00257998|Procedure|Mobilization|manualtherapy techniques
16350991|NCT00257985|Drug|GTN|
16350992|NCT00257972|Drug|aripiprazole|
16350993|NCT00257959|Drug|amiodarone beta blocker sotalol|
16350994|NCT00257946|Procedure|Repair of CDH w/SIS Gold|
16350995|NCT00257946|Procedure|Repair of CDH w/Alloderm|
16350996|NCT00257933|Drug|Prednisolone high dose|4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
16350997|NCT00257933|Drug|Prednisolone lower dose|2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
16350998|NCT00257920|Drug|Zemplar® injection|6 mcg QOD
16350999|NCT00257920|Drug|Hectorol® injection|3.6 mcg QOD
16351070|NCT00257296|Other|Usual Care|Screening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm.
16359006|NCT00188825|Other|placebo|
16351000|NCT00257894|Drug|Baclofen|Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).
16351001|NCT00257894|Drug|Placebo|Matched placebo capsules containing inert filler taken orally for a total of 12 days
16351002|NCT00257881|Drug|CMD-193|
16351003|NCT00257868|Drug|Rivastigmine prevention of delirium|
16351004|NCT00257855|Drug|Lamotrigine|
16351005|NCT00257842|Procedure|Standard treatment, sham feedback and biofeedback therapy|
16351006|NCT00257829|Drug|Methazolamide|
16351007|NCT00257829|Drug|Cisplatin|
16351008|NCT00257816|Drug|Topotecan|"(First stage of accrual, 6 patients)-2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)
~If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg/m2 on days 1, 8, 15, 22, 29 and once during parametrical boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual."
16351009|NCT00257816|Drug|Cisplatin|40 mg/m2 IV (Maximum total dose of 70 mg) on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)
16351010|NCT00257803|Drug|Oxytocin|See detailed description
16351011|NCT00257803|Drug|Saline solution|See detailed description
16351012|NCT00257790|Drug|Tobramycin once a day|
16351013|NCT00257777|Procedure|Myocardial protection techniques|
16351014|NCT00257764|Behavioral|behavioral swallowing exercises/ strategies|
16351015|NCT00257751|Procedure|Aprotinine|
16351016|NCT00257738|Biological|MAGE-A3|Three dose levels of MAGE-A3 vaccine will be tested : 500ug, 1000 ug and 1500 ug
16351017|NCT00257738|Biological|HPV-16 vaccine|Three dose levels of HPV- 16 vaccine will be tested : 500ug, 1000 ug and 1500 ug
16351018|NCT00257725|Drug|B-MPH|Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
16351019|NCT00257712|Drug|TH9507 human growth hormone releasing hormone (GHRH)|1mg subcutaneous injection given daily for 20 weeks
16351020|NCT00257699|Drug|Metronidazole placebo|
16351021|NCT00257699|Drug|ciprofloxacin placebo|
16351022|NCT00257699|Drug|ciprofloxacin|500 mg bid po
16351023|NCT00257699|Drug|metronidazole|250 mg bid po / 250 mg tid po / 500 mg bid po depending on body weight
16351024|NCT00257686|Drug|Pitavastatin|
16351025|NCT00257686|Drug|Pravastatin|
16351026|NCT00257673|Drug|MEM 1003|30 mg twice a day
16351027|NCT00257673|Drug|MEM 1003|90 mg MEM 1003 twice a day
16351028|NCT00257673|Drug|Placebo for MEM 1003|Placebo twice a day
16351029|NCT00257660|Biological|Botulinum toxin type A|500 units
16351030|NCT00257660|Drug|Placebo|500 units
16351031|NCT00257647|Other|SV40 vectors carrying siRNA|in vitro only use of gene therapy
16351032|NCT00257634|Drug|dexamethasone to injury site|
16351033|NCT00257621|Drug|GW640385|
16351034|NCT00257621|Drug|Ritonavir|
16351035|NCT00257608|Drug|bevacizumab|Intravenous repeating dose
16351036|NCT00257608|Drug|placebo|Oral repeating dose
16351037|NCT00257608|Drug|erlotinib HCl|Oral repeating dose
16351038|NCT00257595|Drug|Cetirizine Dry Syrup|
16351039|NCT00257582|Drug|Cetirizine Dry Syrup|
16351040|NCT00257569|Drug|Cetirizine Dry Syrup|
16351041|NCT00257556|Drug|Menotrophin|150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
16351042|NCT00257556|Drug|Follitropin alfa|150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
16351043|NCT00257543|Procedure|Alternative donor bone marrow and cord blood|bone marrow transplant - alternative donors for bone marrow and cord blood transplants
16351044|NCT00257530|Drug|Imiquimod|
16351045|NCT00257491|Drug|Telmisartan|
16351046|NCT00257491|Drug|Telmisartan/HCTZ|
16351047|NCT00257478|Drug|YM155|
16351048|NCT00257465|Biological|Autologous, DNP-modified vaccine (M-Vax)|5.0, 2.5, 0.5, or 0 cells
16351049|NCT00257465|Biological|Autologous, DNP-Modified Melanoma Vaccine|5 million cells
16351050|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|2.5 million cells
16351051|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|0.5 million cells
16351052|NCT00257465|Biological|Autologous, DNP-Modified Vaccine|0 cells
16351053|NCT00257452|Drug|tiotropium 18 mcg or 54 mcg qd|
16351054|NCT00257452|Drug|placebo matching tiotropium qd|
16351055|NCT00257452|Drug|moxifloxacin 200 mg|
16351056|NCT00257426|Drug|octreotide acetate|200mcg,3 times per day, 7 days per week, up to 36 weeks
16351057|NCT00257413|Procedure|Transplantation of autologous endothelial progenitor cells|
16351058|NCT00257400|Behavioral|Interpersonal Psychotherapy (IPT)|Interpersonal Psychotherapy
16351059|NCT00257400|Behavioral|Individual Psychotherapy|Individual Psychotherapy
16351060|NCT00257387|Drug|Cyclosporine|
16351061|NCT00257374|Drug|Gatorade, Pedialyte and New Solution|
16351062|NCT00257361|Drug|D-Cycloserine|
16351063|NCT00257348|Drug|Capecitabine|
16351064|NCT00257348|Drug|Docetaxel|
16351065|NCT00257335|Procedure|IMRT|
16351066|NCT00257322|Drug|GM-CSF|250ug/m^2 SQ QD with a cap of 500mcg SQ QD
16351067|NCT00257309|Drug|Tenecteplase + UFH (+ clopidogrel, since 01/97)|
16351068|NCT00257309|Procedure|Primary angioplasty|
16351069|NCT00257296|Other|Screening and Intervention|Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient
16351071|NCT00257283|Drug|Omega-3-acid ethyl esters 90|
16351072|NCT00257270|Drug|gabapentin|
16351073|NCT00257257|Drug|Rimonabant (SR141716)|
16359007|NCT00188825|Drug|basiliximab|
16351074|NCT00257218|Behavioral|Life style modification|
16351075|NCT00257205|Drug|dacarbazine|decarbazine 1000 mg/m2 IV Q 21 days x 12
16351076|NCT00257205|Drug|CP-675,206|CP-675,206 15 mg/kg IV Q 90 days x 4
16351077|NCT00257205|Drug|temozolomide|temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
16351078|NCT00257192|Drug|placebo|Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
16351079|NCT00257192|Drug|Ziprasidone oral capsules|Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
16351080|NCT00257166|Drug|Ziprasidone oral capsules|Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
16351081|NCT00257166|Drug|placebo oral capsules|Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
16351082|NCT00257153|Device|Coronary thrombus aspiration catheter|
16351083|NCT00257140|Drug|levofloxacin|
16351084|NCT00257127|Biological|Pneumococcal 7-valent conjugate vaccine|0.5 mL administered intramuscularly
16351085|NCT00257127|Biological|Pneumococcal polysaccharide vaccine|0.5 mL administered intramuscularly
16351086|NCT00257127|Biological|Hepatitis B vaccine|0.5 mL administered intramuscularly
16351087|NCT00257127|Biological|Measles, mumps, and rubella virus vaccine, live|0.5 mL administered subcutaneously
16351088|NCT00257114|Drug|bortezomib|
16351089|NCT00257101|Behavioral|self-medication monitoring|
16351090|NCT00257088|Behavioral|whole day first grade program|
16351091|NCT00257075|Drug|Risperidone, oral tablets|
16351092|NCT00257062|Drug|Levofloxacin|
16351093|NCT00257049|Drug|levofloxacin|
16351094|NCT00257036|Drug|levofloxacin|
16351095|NCT00257023|Drug|paliperidone|
16351096|NCT00257010|Drug|Almotriptan Malate|Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
16351097|NCT00256997|Drug|Risperidone long-acting injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
16351098|NCT00256997|Drug|Oral atypical Antipsychotic|Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
16351099|NCT00256984|Procedure|Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler|
16351100|NCT00256971|Procedure|meniscectomy|
16351101|NCT00256958|Procedure|total knee replacement|
16351102|NCT00256945|Procedure|dental restorative material surface preparation|
16351103|NCT00256932|Drug|alvimopan|0.5 mg
16351104|NCT00256932|Drug|Placebo|
16351105|NCT00256919|Drug|GW856553|
16351106|NCT00256893|Drug|ropinirole|
16351107|NCT00256880|Drug|GW786034|
16351108|NCT00256867|Drug|GSK523338|
16351109|NCT00256854|Drug|Ropinirole IR 1 mg|Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.
16351110|NCT00256854|Drug|Ropinirole IR 2 mg|Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.
16351111|NCT00256854|Drug|Ropinirole IR 1 mg Placebo|Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.
16351112|NCT00256854|Drug|Ropinirole IR 2 mg Placebo|Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
16351113|NCT00256854|Drug|Ropinirole CR 2 mg|Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.
16351114|NCT00256854|Drug|Ropinirole CR 3 mg|Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.
16351115|NCT00256854|Drug|Ropinirole CR 2 mg Placebo|Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
16351116|NCT00256854|Drug|Ropinirole CR 3 mg Placebo|Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
16351117|NCT00256841|Drug|Chemotherapy|
16351118|NCT00256841|Procedure|Radiation Therapy|
16351119|NCT00256828|Drug|didanosine + lamivudine + efavirenz|
16351120|NCT00256815|Drug|chemotherapy|
16351121|NCT00256815|Procedure|Radiation|
16351122|NCT00256802|Device|MR-angiography, GTN|
16351123|NCT00256789|Procedure|Radiation|
16351124|NCT00256789|Drug|Chemotherapy|
16351128|NCT00256750|Drug|Cyclosporine (CsA)|tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
16351129|NCT00256750|Drug|Belatacept LI (less intensive)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
16351192|NCT00256204|Drug|Rasagiline Mesylate|tablet, 1mg once daily
16359008|NCT00188812|Drug|donepezil hcl|
16351130|NCT00256750|Drug|Belatacept MI (more intensive)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
16351131|NCT00256737|Drug|Omeprazole|
16351132|NCT00256724|Device|Impedance Threshold Device|Active impedance threshold device
16351133|NCT00256724|Device|sham ITD|sham impedance threshold device
16351134|NCT00256711|Drug|Gefitinib|
16351135|NCT00256711|Drug|Vinorelbine|
16351136|NCT00256698|Drug|Fulvestrant|intramuscular injection 250 mg loading dose (LD) regimen
16351137|NCT00256698|Drug|Anastrozole|1 mg oral tablet
16351138|NCT00256685|Drug|DVS-233 SR|
16351139|NCT00256672|Device|Thoraco-Lumbar-Sacral-Orthoses (TLSO) / Flex-Foam|TLSO back brace, Flex-Foam (Posterior Opening)
16351140|NCT00256659|Behavioral|Early assessment and referral to ancillary care services vs. standard care|
16351141|NCT00256646|Drug|Rosiglitazone|ROSIGLITAZONE (roe si GLI ta zone) helps to treat type 2 diabetes. It helps to control blood sugar. Treatment is combined with diet and exercise.
16351142|NCT00256620|Procedure|Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized|
16351143|NCT00256594|Device|prescription form|Two prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions
16351144|NCT00256581|Procedure|Additional rest and stress image sets on new camera|
16351145|NCT00256568|Behavioral|reporting system|Nurses and office staff were asked to report all communications with community pharmacists regarding prescription problems
16351146|NCT00256555|Drug|Nutropin AQ|
16351147|NCT00256542|Drug|Alkalinized Lidocaine-Heparin|
16351148|NCT00256529|Procedure|EGD with biopsies|All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
16351149|NCT00256516|Other|Eco-Atkins diet (high vegetable protein and vegetable fat)|
16351150|NCT00256516|Other|NCEP diet|
16351151|NCT00256503|Behavioral|Cognitive-Behavioral Therapy for Insomnia|Insomnia Subjects receive CBT-I
16351152|NCT00256490|Procedure|PET/CT 20 days after the first cycle of chemotherapy|
16351153|NCT00256477|Behavioral|Sudarshan KRIYA Breathing Technique|
16351154|NCT00256464|Behavioral|Multi-component Yoga Intervention|
16351155|NCT00256451|Drug|Naltrexone|50 mg/day for two days prior to the alcohol challenge session
16351156|NCT00256451|Drug|placebo|placebo pills
16351157|NCT00256451|Other|alcohol|190 proof alcohol prepared to 11% volume mixed with fruit juice.
16351158|NCT00256451|Other|Sham alcohol|non-alcoholic placebo alcohol
16351159|NCT00256438|Device|Transcranial Direct Current Stimulation|
16351160|NCT00256425|Behavioral|Cognitive rehabilitation|
16351161|NCT00256412|Drug|Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day|Placebo and Omega 3 capsules. All participants receive 4 capsules with either 0, 2, or 4 capsules containing omega 3.
16351162|NCT00256412|Drug|Placebo|4 capsules of placebo each day
16351163|NCT00256399|Drug|Alfuzosin 10 mg|
16351164|NCT00256386|Device|Electronic Medical Record (EMR) to clinician's in-basket|
16351165|NCT00256386|Device|Automated Voice Message (AVM) reminder to patient's phone|
16351166|NCT00256386|Procedure|Pharmacy Team phone call-letter followup|
16351167|NCT00256373|Procedure|Mod. functional restoration-Individ. dynamic back-muscle|
16351168|NCT00256360|Drug|dose dense with neulasta|
16351169|NCT00256347|Drug|intramuscular injections of morphine|
16351170|NCT00256334|Drug|Resveratrol|Patients were randomly assigned to one of four dose cohorts: plant-derived resveratrol tablets (purchased through the Life Extension Foundation, Scottsdale, AZ) at a dose of 80 mg/day, plant-derived resveratrol tablets at a dose of 20 mg/day, Grape Powder (GP) dissolved in water and taken orally (supplied by the California Table Grape Commission) at a dose of 120 g/day, and GP at a dose of 80 g/day.
16351171|NCT00256321|Drug|Oxaliplatin|Oxaliplatin 70mg/m2 IV on Days 1 and 8
16351172|NCT00256321|Drug|Capecitabine|Capecitabine 1000mg/m2 PO BID from Days 1 through 14.
16351173|NCT00256321|Drug|Celecoxib|Celecoxib 400mg PO BID from Days 1 through 21.
16351174|NCT00256308|Drug|Oxaliplatin|70mg/m2 IV over 120 min once a week during radiation
16351175|NCT00256308|Procedure|Radiation|200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday
16351176|NCT00256295|Drug|Gemcitabine|1000 mg/m2 IV over 100 minutes Every 21 days
16351177|NCT00256295|Drug|Oxaliplatin|65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
16351178|NCT00256282|Drug|Vinorelbine|30 mg/m2 IV over 6-10 min every 14 days
16351179|NCT00256282|Drug|Docetaxel|40mg/m2 IV over 1 hour every 14 days
16351180|NCT00256282|Drug|Sargramostim|250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
16351181|NCT00256269|Drug|Oxaliplatin|40 mg/m2 IV over 60 minutes Every 21 days
16351182|NCT00256269|Drug|Irinotecan|60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days
16351183|NCT00256256|Drug|glucagon-like-peptide-1|Dose: 1.2pmol/kg/min for 6 hours
16351184|NCT00256243|Drug|Doxorubicin|60 mg/m2 IV, bolus once every 14 days x 2-4 cycles
16351185|NCT00256243|Drug|Cyclophosphamide|600 mg/m2 IV once every 14 days x 2-4 cycles
16351186|NCT00256243|Drug|Paclitaxel|80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose
16351187|NCT00256243|Drug|Carboplatin|Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose
16351188|NCT00256243|Drug|GM-CSF|250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
16351189|NCT00256243|Drug|Trastuzumab|AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
16351190|NCT00256230|Drug|Disulfiram (DSF)|DSF pills at 250 mg will be given orally, two times a day. If this dose is tolerated, the dose will be escalated until the maximum tolerated dose is reached. Treatment will continue every day for 3 months or longer unless the disease gets worse, the side effects are too dangerous for the subject, or the subject decides to discontinue treatment.
16351191|NCT00256217|Drug|Anastrozole|1 mg. oral every day for 2 - 4 weeks
16351193|NCT00256204|Drug|Rasagiline Mesylate|tablet, 2mg once daily
16351194|NCT00256204|Other|Placebo|Placebo
16351195|NCT00256191|Drug|TPI 287 Injection|
16351196|NCT00256178|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
16351197|NCT00256178|Drug|Lapaquistat acetate and simvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
16351198|NCT00256178|Drug|Simvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.
16351199|NCT00256165|Device|Tissue valve|Aortic valve replacement
16351200|NCT00256152|Device|AF Suppression Pacing Algorithm|
16351201|NCT00256139|Drug|Raptiva|
16351202|NCT00256126|Drug|Saizen|Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
16351203|NCT00256126|Drug|Saizen|Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
16351204|NCT00256113|Drug|Saredutant succinate (SR48968C)|
16351205|NCT00256100|Drug|Fondaparinux Sodium|The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
16351206|NCT00256087|Drug|Probiotic Lactobacillus|
16351207|NCT00256087|Other|Lactose Powder|
16351208|NCT00256074|Procedure|Enteral feeding formula|
16351209|NCT00256048|Procedure|Nasojejunal feeding|
16351210|NCT00256035|Procedure|Measuring IL-4 levels|
16351211|NCT00256022|Drug|Lactobacillus Probiotic|
16351212|NCT00256022|Other|Lactose Powder|
16351213|NCT00256009|Drug|Cytotec|
16351214|NCT00255996|Drug|linezolid|
16351215|NCT00255983|Drug|Faropenem medoxomil|600 mg BID for 5 days
16351216|NCT00255983|Drug|placebo|placebo tablets BID for 5 days
16351217|NCT00255970|Other|DFDBA|Demineralized Freeze Dried Allograft bone
16351218|NCT00255970|Device|Regenafil|Demineralized Freeze Dried Bone in a porcine gel carrier
16351219|NCT00255957|Drug|HES administration|
16351220|NCT00255957|Drug|Hydroxy Ethyl Starch administration to stroke patients|
16351221|NCT00255944|Behavioral|Youthnet Internet-based program|Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness.
16351222|NCT00255944|Behavioral|Control Internet based program|The control program will deliver standard STD/HIV prevention messages.
16351223|NCT00255931|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy and Relaxation/biofeedback
16351224|NCT00255931|Behavioral|Attention Placebo|Untrained relaxation
16351225|NCT00255918|Drug|Dimethoxybenzylidene anabaseine (DMXB-A)|DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose
16351226|NCT00255918|Drug|Placebo|Placebo dosed to match active medication
16351227|NCT00255918|Drug|Dimethoxybenzylidene anabaseine (DMXB-A)|DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose
16351228|NCT00255905|Behavioral|Cognitive behavioral therapy (CBT) for insomnia|
16351229|NCT00255905|Behavioral|Clinician monitoring|
16351230|NCT00255879|Drug|Quetiapine|
16351231|NCT00255879|Drug|Risperidone|
16351232|NCT00255879|Drug|Olanzapine|
16351233|NCT00255866|Behavioral|Skills training for the care of dementia patients|
16351234|NCT00255840|Behavioral|Monitoring by an HIV-trained medical doctor|Participants will receive care from an HIV-trained medical doctor
16351235|NCT00255840|Behavioral|Monitoring by an HIV-trained primary care nurse|Participants will receive care from an HIV-trained primary care nurse
16351236|NCT00255840|Drug|Efavirenz|600 mg tablet taken orally daily
16351237|NCT00255840|Drug|Lamivudine|150 mg tablet taken orally daily
16351238|NCT00255840|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100mg ritonavir tablet taken orally twice daily
16351239|NCT00255840|Drug|Nevirapine|200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily
16351240|NCT00255840|Drug|Stavudine|Tablet taken orally daily. Dosage depends on weight.
16351241|NCT00255827|Biological|HyperAcute-Pancreatic Cancer Vaccine|
16351242|NCT00255814|Radiation|radiation therapy|
16351243|NCT00255801|Drug|Targretin® (bexarotene)|
16351244|NCT00255801|Drug|pegylated liposomal doxorubicin hydrochloride|
16351245|NCT00255788|Drug|everolimus|
16351246|NCT00255775|Dietary Supplement|broccoli sprout extract|
16351247|NCT00255775|Procedure|complementary or alternative medicine procedure|
16351248|NCT00255762|Drug|carboplatin|Given IV
16351249|NCT00255762|Drug|paclitaxel|Given IV
16351250|NCT00255762|Biological|bevacizumab|Given IV
16351251|NCT00255762|Other|laboratory biomarker analysis|Correlative studies
16351252|NCT00255749|Biological|epoetin alfa|
16351253|NCT00255723|Drug|carboplatin|Given IV
16351254|NCT00255723|Drug|etoposide|Given IV
16351255|NCT00255723|Drug|ifosfamide|Given IV
16351256|NCT00255710|Biological|filgrastim|
16351257|NCT00255710|Drug|cyclophosphamide|
16351258|NCT00255710|Drug|fludarabine phosphate|
16351259|NCT00255710|Drug|mycophenolate mofetil|
16351260|NCT00255710|Drug|tacrolimus|
16351261|NCT00255710|Procedure|allogeneic bone marrow transplantation|
16351262|NCT00255710|Procedure|peripheral blood stem cell transplantation|
16351263|NCT00255710|Radiation|radiation therapy|
16351332|NCT00255125|Drug|Soy Supplement|Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
16351576|NCT00253500|Drug|epirubicin hydrochloride|120 MG q 2 weeks for 4 cycles
16351577|NCT00253500|Procedure|conventional surgery|to remove small piece of cancer
16351578|NCT00253487|Drug|O6-benzylguanine|
16351264|NCT00255697|Procedure|psychosocial assessment and care|Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.
16351265|NCT00255697|Procedure|quality-of-life assessment|Patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including Functional Assessment of Cancer Therapy (FACT), Spiritual tool, Quality and Satisfaction with Treatment (QUEST), and Profile of Mood State (POMS), at baseline and at 3 and 12 months. Caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the Caregiver Reaction Assessment (CRA), Quest, and POMS, at baseline and at 3 and 12 months. Caregivers complete the Quality of Death and Dying (QODD) questionnaire 2-3 months after the patient's death.
16351266|NCT00255684|Biological|graft-versus-tumor induction therapy|
16351267|NCT00255684|Drug|cyclophosphamide|
16351268|NCT00255684|Drug|cyclosporine|
16351269|NCT00255684|Drug|fludarabine phosphate|
16351270|NCT00255684|Drug|mycophenolate mofetil|
16351271|NCT00255684|Procedure|umbilical cord blood transplantation|
16351272|NCT00255684|Radiation|radiation therapy|
16351273|NCT00255671|Other|Questionnaire|Patients complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.
16351274|NCT00255658|Drug|sorafenib tosylate|Given orally
16351275|NCT00255658|Drug|temsirolimus|Given IV
16351276|NCT00255658|Other|laboratory biomarker analysis|Correlative studies
16351277|NCT00255619|Device|Baxter's UltraBag® and FMC Andy·Disc®|
16351278|NCT00255606|Drug|docetaxel|Given in 3- or 4- week courses
16351279|NCT00255606|Drug|prednisone|Given in 3- or 4- week courses
16351280|NCT00255593|Drug|rituximab|
16351281|NCT00255580|Drug|Smoked cannabis|
16351282|NCT00255567|Drug|Sodium Stibogluconate|Sodium Stibogluconate 20mg/kg/day for 30 days
16351283|NCT00255567|Drug|Paromomycin sulphate|Paromomycin sulphate
16351284|NCT00255567|Drug|SSG and Paromomycin sulphate|SSG and Paromomycin Sulphate 17 days
16351285|NCT00255554|Behavioral|Dialectical Behavioral Therapy|
16351286|NCT00255554|Drug|Escitalopram|
16351287|NCT00255541|Drug|Tesaglitazar|
16351288|NCT00255541|Drug|Glibenclamide|
16351289|NCT00255528|Drug|metoprolol succinate|
16351290|NCT00255515|Drug|Quetiapine fumarate|oral
16351291|NCT00255515|Drug|conventional treatment for schizophrenia|various standard therapies
16351292|NCT00255502|Drug|metoprolol succinate|
16351293|NCT00255489|Drug|Gefitinib|
16351294|NCT00255489|Procedure|palliative thoracic radiotherapy|
16351295|NCT00255476|Drug|gefitinib|
16351296|NCT00255476|Drug|cisplatin|
16351297|NCT00255476|Drug|5-flourouracil|
16351298|NCT00255463|Drug|Anastrazole|
16351299|NCT00255463|Drug|Gefitinib|
16351300|NCT00255450|Drug|ferumoxytol or placebo|
16351301|NCT00255437|Drug|ferumoxytol or oral iron|
16351302|NCT00255424|Drug|ferumoxytol or oral iron|
16351303|NCT00255385|Drug|Micronutrient (Zinc and Iron) fortification|
16351304|NCT00255385|Drug|Pre and Probiotic fortification|
16351305|NCT00255372|Drug|PEG 4000 (Forlax®)|Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
16351306|NCT00255372|Drug|Lactulose active and Lactulose placebo|Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.
16351307|NCT00255359|Drug|XTL-2125|
16351308|NCT00255346|Drug|Dasatinib (BMS-354825)|70 mg orally twice daily
16351309|NCT00255333|Drug|INNO-105|
16351310|NCT00255320|Drug|VIP|
16351311|NCT00255307|Drug|CVT-E002 ginseng extract|
16351312|NCT00255294|Drug|Cellulose sulfate vaginal gel|
16351313|NCT00255281|Drug|AZD7009, no generic name available|
16351314|NCT00255268|Drug|Goserelin|
16351315|NCT00255268|Drug|Bicalutamide|
16351316|NCT00255255|Drug|Budesonide/Formoterol|
16351317|NCT00255242|Drug|Simvastatin treatment for 28 days|40 mg / day
16351318|NCT00255229|Drug|Glutamine|Glutamine 10 g four times daily starting two days before treatment for six days in total
16351319|NCT00255229|Other|Placebo|Glutamine placebo
16351320|NCT00255216|Drug|Policosanol supplement (oral capsule) vs. placebo|
16351321|NCT00255190|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
16351322|NCT00255190|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
16351323|NCT00255177|Drug|VGX-410 (Mifepristone)|VGX-410 tablets taken daily or twice daily for 28 days
16351324|NCT00255177|Drug|Placebo|Placebo for VGX-410 tablets taken daily or twice daily for 28 days
16351325|NCT00255164|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
16351326|NCT00255164|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
16351327|NCT00255164|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
16351328|NCT00255151|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
16351329|NCT00255151|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
16351330|NCT00255151|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
16351331|NCT00255138|Drug|Atomoxetine|
16351567|NCT00253526|Procedure|chemotherapy|
16351568|NCT00253526|Procedure|conventional surgery|
16351333|NCT00255125|Drug|Placebo|Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
16351334|NCT00255112|Behavioral|family based cognitive behavior therapy|newly developed family based cognitive behavior therapy for children with separation anxiety disorder over 5 years old
16351335|NCT00255099|Drug|TMC125|2 x 100 mg tablets b.i.d. / 96 weeks
16351336|NCT00255099|Drug|Placebo|2 tablets b.i.d. / 96 weeks
16351337|NCT00255086|Drug|Memantine|10mg Memantine
16351338|NCT00255086|Drug|Placebo pill|10mg placebo pill
16351339|NCT00255073|Drug|baclofen|
16351340|NCT00255047|Biological|DAPTACEL®. (DTaP), IPOL®., and ActHIB®.|0.5 mL, Intramuscular
16351341|NCT00255047|Biological|Pentacel®: DTaP-IPV/Hib combined|0.5 mL, Intramuscular
16351342|NCT00255047|Biological|DTaP-IPV and ActHIB®|0.5 mL, Intramuscular
16351343|NCT00255047|Biological|Pentacel®: DTaP-IPV/Hib combined|0.5 mL, Intramuscular
16351344|NCT00255034|Biological|Peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
16351345|NCT00255034|Biological|Peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
16351346|NCT00255034|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks
16351347|NCT00255034|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks
16351348|NCT00255021|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac|0.5 mL, IM
16351349|NCT00255008|Biological|peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
16351350|NCT00255008|Drug|ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
16351351|NCT00255008|Biological|peginterferon alfa-2b|Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
16351352|NCT00255008|Drug|ribavirin|200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks
16351353|NCT00254995|Biological|None administered in this study|N/A in this study
16351354|NCT00254982|Biological|Infliximab|Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
16351355|NCT00254969|Biological|Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib|0.5 mL, Im
16351356|NCT00254956|Drug|ciclesonide (XRP1526)|
16351357|NCT00254930|Drug|risperidone|
16351358|NCT00254917|Biological|Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine|0.5 mL, IM
16351359|NCT00254917|Biological|Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine|0.5 mL, IM
16351360|NCT00254904|Drug|Cisplatin|Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
16351361|NCT00254904|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
16351362|NCT00254904|Drug|PF-3512676|PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
16351363|NCT00254904|Drug|Cisplatin|Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
16351364|NCT00254904|Drug|Gemcitabine + Cisplatin|Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
16351365|NCT00254891|Drug|PF-3512676 + Paclitaxel + Carboplatin|"PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
~Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
~Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles."
16351366|NCT00254891|Drug|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
~Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles."
16351367|NCT00254878|Drug|Methylphenidate hydrochloride|
16351368|NCT00254865|Drug|EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.75 mg of ethinyl estradiol (versus CILEST® tablets).|
16351369|NCT00254852|Procedure|Posterior Lateral Fusion (PLF)|Posterior lateral fusion (PLF) of the lumbar spine
16351370|NCT00254852|Procedure|Anterior Lumbar Interbody Fusion (ALIF)|Anterior lumbar interbody fusion (ALIF)
16351371|NCT00254852|Procedure|Transforaminal lumbar interbody fusion (TLIF)|Transforaminal lumbar interbody fusion (TLIF)
16351372|NCT00254852|Procedure|Posterior lumbar interbody fusion (PLIF)|Posterior lumbar interbody fusion (PLIF)
16351373|NCT00254852|Procedure|Extreme lateral interbody fusion (XLIF)|Extreme lateral interbody fusion (XLIF)
16351374|NCT00254826|Biological|YF-VAX® plus saline|YF-VAX® plus saine
16351375|NCT00254826|Biological|17D YF Vaccine plus Ig,|17D YF Vaccine plus Ig, one vaccine on day 0
16351376|NCT00254813|Drug|Quetiapine|
16351377|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
16351378|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
16351379|NCT00254800|Drug|ethinyl estradiol and levonorgestrel; exenatide|Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
16351380|NCT00254787|Drug|IR (Immediate-Release) quetiapine fumarate (drug)|
16351381|NCT00254774|Drug|quetiapine fumarate or valproate|
16351382|NCT00254761|Drug|Cannabis|
16351383|NCT00254748|Drug|Quetiapine fumarate|flexible doses from 200 mg to 600 mg
16351384|NCT00254748|Drug|Placebo|placebo
16351385|NCT00254735|Drug|quetiapine fumarate|
16351386|NCT00254735|Drug|SSRI/Clomipramine|
16351387|NCT00254722|Drug|Autologous bone marrow precursor cell harvest and transplant|Bone marrow harvest (3 ml/kg of body weight) performed between 12 and 30 hours post injury, followed by single intravenous infusion of bone marrow progenitor cells - target dose is 6x10^6 mononuclear cells/kg body weight, administered within 36 hours of injury
16351388|NCT00254709|Drug|Sirolimus|
16351389|NCT00254696|Drug|Extended-Spectrum-Lactamases (ESBLs)|
16351390|NCT00254683|Device|PET/CT with FDG|PET/CT before start of neoadjuvant CRT, at 6 weeks, 12 weeks, following CRT completion and 12mo, 24mo following CRT for those considered complete responders
16351391|NCT00254670|Drug|Naltrexone|
16351392|NCT00254657|Drug|Levetiracetam|Started with one 500 mg tablet/day and titrated upward as tolerated over 6 weeks by 500 mg/week to a maximum dose of 3000 mg/day.
16351393|NCT00254657|Drug|Placebo|
16351394|NCT00254644|Procedure|Morphological and functional MRI|one time
16351395|NCT00254631|Drug|Oxycodone hydrochloride|
16351396|NCT00254618|Drug|mesalamine|oral tablet, 30 mg mesalamine/day for 28 days
16351397|NCT00254618|Drug|mesalamine|oral tablet, 60 mg mesalamine/day for 28 days
16351398|NCT00254618|Drug|mesalamine|oral tablet, 90 mg mesalamine/day for 28 days
16351399|NCT00254592|Drug|Doxorubicin|60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles
16351400|NCT00254592|Drug|Cyclophosphamide|600 mg/m2 IV once a day every 14 days x 2-4 cycles
16351401|NCT00254592|Drug|Carboplatin|AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose
16351402|NCT00254592|Drug|Nab-paclitaxel|100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose
16351403|NCT00254592|Drug|GM-CSF|250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
16351404|NCT00254592|Drug|Trastuzumab|4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
16351405|NCT00254592|Drug|Bevacizumab|10mg/kg q 2 wks
16351406|NCT00254579|Drug|CP-675,206|15 mg/kg Q12W dosing regimen
16351407|NCT00254566|Other|Moxifloxacin Placebo|1 capsule once daily for 5 days
16351408|NCT00254566|Drug|Moxifloxacin|1 X 400mg capsule once daily for 5 days
16351409|NCT00254566|Other|Azithromycin SR Placebo|single dose, oral.
16351410|NCT00254566|Drug|Azithromycin SR|single dose 2.0 g oral
16351411|NCT00254553|Drug|Testim 1% (testosterone gel)|Testim_ 100 mg: two tubes of 50 mg of Testim_per day
16351412|NCT00254553|Drug|Placebo|two tubes of placebo per day
16351413|NCT00254540|Drug|SU011248 capsule|50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
16351414|NCT00254514|Drug|somatropin|
16351415|NCT00254501|Behavioral|Pharmacist Counseling|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
16351416|NCT00254501|Behavioral|Educational materials|Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.
16351417|NCT00254488|Drug|Lithium (LI)|The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).
16351418|NCT00254488|Drug|Divalproex (DV)|Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).
16351419|NCT00254475|Drug|simvastatin|
16351420|NCT00254475|Drug|valsartan|
16351421|NCT00254462|Drug|Atomoxetine|Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
16351422|NCT00254462|Drug|Placebo|Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
16351423|NCT00254462|Behavioral|Parent Training|All children will receive parent training for the duration of the study.
16351424|NCT00254449|Drug|NGX-4010|
16351425|NCT00254436|Drug|Procrit (epoetin alfa)|Weekly dose
16351426|NCT00254423|Drug|Dasatinib|Given PO
16351427|NCT00254423|Other|Laboratory Biomarker Analysis|Correlative studies
16351428|NCT00254423|Other|Pharmacological Study|Correlative studies
16351429|NCT00254423|Other|Quality-of-Life Assessment|Ancillary studies
16351430|NCT00254423|Other|Questionnaire Administration|Ancillary studies
16351431|NCT00254410|Drug|Fludarabine|Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6
16351432|NCT00254410|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6.
16351433|NCT00254410|Drug|Mitoxantrone|Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6.
16351434|NCT00254410|Drug|Rituximab|Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6.
16351435|NCT00254410|Drug|Filgrastim|Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.
16351436|NCT00254397|Drug|Leuprolide|A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).
16351437|NCT00254397|Biological|GP100: 209-217(210M) Peptide|1.0 ml subcutaneous injection in extremities.
16351438|NCT00254397|Biological|MAGE-3 Peptide|1.0 ml subcutaneous injection in extremities.
16351439|NCT00254384|Drug|Cisplatin|Given IV
16351440|NCT00254384|Drug|Docetaxel|Given IV
16351441|NCT00254384|Drug|Erlotinib|Given PO
16351442|NCT00254384|Drug|Erlotinib Hydrochloride|Given PO
16351443|NCT00254384|Other|Laboratory Biomarker Analysis|Correlative studies
16351444|NCT00254371|Procedure|Androgen Replacement|
16351445|NCT00254345|Procedure|coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin|
16351446|NCT00254319|Drug|Avastin, Alimta|
16351447|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC Solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
16351579|NCT00253487|Drug|busulfan|
16351448|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC Solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
16351449|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
16351450|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
16351451|NCT00254293|Drug|Abatacept or Placebo (both as IV & SC solution)|Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
16351452|NCT00254293|Drug|Abatacept|Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly
16351453|NCT00254280|Procedure|Intense Pulsed Light + paring versus paring alone|
16351454|NCT00254267|Drug|AMG 706|AMG 706 125mg, oral, once a day
16351455|NCT00254254|Drug|Exenatide - Exenatide - Placebo|Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.
16351456|NCT00254254|Drug|Exenatide - Placebo - Exenatide|Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
16351457|NCT00254254|Drug|Placebo - Exenatide - Exenatide|Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
16351458|NCT00254241|Drug|Seroquel and Risperidone|
16351459|NCT00254228|Device|Electrotactile sensory substitution|
16351460|NCT00254215|Behavioral|high protein & low glycemic index diets|
16351461|NCT00254202|Drug|iloperidone|
16351462|NCT00254202|Drug|active comparator|
16351463|NCT00254202|Drug|placebo|
16351464|NCT00254189|Drug|Levonorgestrel|
16351465|NCT00254189|Drug|Ethinyl Estradiol|
16351466|NCT00254176|Dietary Supplement|Parenteral cysteine-HCl supplementation|cysteine-HCl supplementation 121 mg per kg per day
16351467|NCT00254176|Dietary Supplement|Placebo - added premasol|Premasol 121 mg per kg per day
16351468|NCT00254163|Drug|Fludarabine|
16351469|NCT00254163|Drug|Cyclophosphamide|
16351470|NCT00254163|Drug|Rituximab|
16351471|NCT00254163|Drug|Pentostatin|
16351472|NCT00254150|Procedure|Increase oxygen extraction rate|
16351473|NCT00254137|Drug|capecitabine|
16351474|NCT00254137|Drug|irinotecan|
16351475|NCT00254137|Drug|oxaliplatin|
16351476|NCT00254137|Drug|cetuximab|
16351477|NCT00254124|Device|The Diet Plate (R) TM portion control plate and bowl|
16351478|NCT00254111|Device|Ultra Probe Laser System|
16351479|NCT00254085|Drug|Insulin Aspart|
16351480|NCT00254072|Procedure|3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass|The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy.
16351481|NCT00254059|Procedure|Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography|
16351482|NCT00254046|Drug|TMC125|2 X100 mg tablets b.i.d.96 weeks
16351483|NCT00254046|Drug|Placebo|2 tablets b.i.d.96 weeks
16351484|NCT00254033|Drug|Dextroamphetamine|
16351485|NCT00254033|Drug|Methylphenidate|
16351486|NCT00254020|Drug|Citalopram|Patients who are found to have major depression will be referred to a psychologist
16351487|NCT00254007|Drug|citalopram (celexa)|20(1 tablet)-50(2 1/2 tablets) mg/day for a period of 6 or 10 weeks
16351488|NCT00253994|Procedure|Acupuncture|
16351489|NCT00253981|Device|Monochromatic Near-Infrared Light Energy (MIRE)|Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
16351490|NCT00253968|Drug|Eplivanserin|oral administration
16351491|NCT00253968|Drug|placebo|oral administration
16351492|NCT00253955|Drug|Levofloxacin|
16351493|NCT00253955|Drug|Piperacillin/Tazobactam|
16351494|NCT00253942|Procedure|Injecting bee venom as a treatment for OA|
16351495|NCT00253929|Drug|Intra-arterial infusion of adenosine|
16351496|NCT00253929|Drug|intra-arterial infusion of caffeine|
16351497|NCT00253929|Drug|intra-arterial infusion of acetylcholine|
16351498|NCT00253929|Drug|intra-arterial infusion of sodium nitroprusside|
16351499|NCT00253929|Procedure|Occlusion of arm-circulation by inflation of upper-arm cuff to 200mmHg for 2, 5 and 13 minutes|
16351500|NCT00253916|Behavioral|Aerobic cardiovascular exercise program|Aerobic cardiovascular exercise program
16351501|NCT00253916|Behavioral|Resistance Exercise Program|Resistance Exercise Program
16351502|NCT00253903|Drug|eplivanserin (SR46349)|oral administration
16351503|NCT00253903|Drug|placebo|oral administration
16351504|NCT00253890|Drug|Trazodone|50 mg 1-3 capsules at bedtime for 3 months
16351505|NCT00253890|Drug|Placebo|1-3 at bedtime
16351506|NCT00253877|Other|Complication rate|All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology. The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.
16351569|NCT00253526|Procedure|growth factor antagonist therapy|
16351570|NCT00253526|Procedure|monoclonal antibody therapy|
16351571|NCT00253526|Procedure|surgery|
16351572|NCT00253513|Drug|fludarabine|30 mg/m2, IV for 5 days
16351573|NCT00253513|Drug|treosulfan|12 or 14 g/m2, IV for 5 days
16351574|NCT00253513|Procedure|allogeneic blood or bone marrow transplantation|bone marrow or peripheral blood stem cells
16351575|NCT00253500|Biological|pegfilgrastim|6 mg in a syringe
16351507|NCT00253851|Drug|unfractionated heparin|Five minutes prior to tourniquet inflation, patients will receive 0.1 ml/kg/minute of intravenous (IV) unfractionated heparin (1000 units/ml) or placebo (normal saline solution). Five minutes will be allowed to elapse to ensure complete systemic heparinization. The operated limb will then be elevated and exsanguinated using an Esmarch bandage. Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period. The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group. Study drugs will be administered by the anaesthesiologist via a peripheral IV. This new method of intraoperative regional heparinization has been used in two previous studies (Giachino et al., 2001; Giachino et al., 1985) with no adverse effects noted.
16351508|NCT00253838|Procedure|Restoration HA stem|The Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surfacing and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem.
16351509|NCT00253838|Procedure|Solution stem|The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
16351510|NCT00253825|Device|mCIMT combined with or without eye patching|
16351511|NCT00253812|Procedure|flexible sigmoidoscopy|
16351512|NCT00253799|Device|Hylan GF-20|
16351513|NCT00253786|Other|Intensive multifactorial therapy|Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
16351514|NCT00253786|Other|Standard therapy|Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
16351515|NCT00253773|Drug|acetominophen, sulfer amino acids; cysteine and methionine|
16351516|NCT00253760|Drug|dietary amino acids; cysteine and methionine|
16351517|NCT00253747|Drug|Osmotic-Release Methylphenidate|OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
16351518|NCT00253747|Drug|Placebo|OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
16351519|NCT00253734|Biological|Fluzone® (IM)|15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
16351520|NCT00253734|Biological|Fluzone®|9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
16351521|NCT00253721|Drug|Melphalan|"All levels: Every 4 weeks for up to one year
~Dose Escalation Plan:
~Level 1: 4mg/m2/day x 2 days
~Level 2: 6mg/m2/day x 2 days
~Level 3: 8mg/m2/day x 2 days
~Level 4: 10mg/m2/day x 2 days
~Level 5: 12mg/m2/day x 2 days"
16351522|NCT00253708|Procedure|management of therapy complications|
16351523|NCT00253708|Procedure|massage therapy|
16351524|NCT00253708|Procedure|pain therapy|
16351525|NCT00253708|Procedure|psychosocial assessment and care|
16351526|NCT00253708|Procedure|quality-of-life assessment|
16351527|NCT00253695|Device|Wrist Actigraphy|Wrist actigraph will record participants' sleeping patterns.
16351528|NCT00253669|Other|laboratory biomarker analysis|
16351529|NCT00253669|Other|physiologic testing|
16351530|NCT00253669|Procedure|management of therapy complications|
16351531|NCT00253643|Dietary Supplement|green tea catechin extract|Given orally 2 times/day
16351532|NCT00253643|Dietary Supplement|fish oil|Given orally 3 times/day
16351533|NCT00253643|Other|placebo|Given olive oil placebo orally 3 times/day
16351534|NCT00253643|Other|placebo|Given green tea placebo orally 2 times/day
16351535|NCT00253630|Other|Laboratory Biomarker Analysis|Correlative studies
16351536|NCT00253630|Drug|Vorinostat|Given PO
16351537|NCT00253617|Drug|porfimer sodium|
16351538|NCT00253617|Procedure|adjuvant therapy|
16351539|NCT00253617|Procedure|laser therapy|
16351540|NCT00253617|Procedure|photodynamic therapy|
16351541|NCT00253617|Procedure|phototherapy|
16351542|NCT00253591|Drug|cisplatin|
16351543|NCT00253591|Drug|vinorelbine tartrate|
16351544|NCT00253591|Radiation|radiation therapy|
16351545|NCT00253578|Drug|sorafenib tosylate|Given PO
16351546|NCT00253578|Other|laboratory biomarker analysis|Correlative studies
16351547|NCT00253565|Drug|capecitabine|
16351548|NCT00253565|Drug|imatinib mesylate|
16351549|NCT00253552|Biological|filgrastim|
16351550|NCT00253552|Drug|busulfan|
16351551|NCT00253552|Drug|cyclophosphamide|
16351552|NCT00253552|Drug|cyclosporine|
16351553|NCT00253552|Drug|etoposide|
16351554|NCT00253552|Drug|methotrexate|
16351555|NCT00253552|Procedure|allogeneic bone marrow transplantation|
16351556|NCT00253552|Radiation|radiation therapy|
16351557|NCT00253539|Drug|arzoxifene hydrochloride|Given orally
16351558|NCT00253539|Drug|tamoxifen citrate|Given orally
16351559|NCT00253539|Other|placebo|Given orally
16351560|NCT00253526|Drug|bevacizumab|
16351561|NCT00253526|Drug|gemcitabine hydrochloride|
16351562|NCT00253526|Procedure|adjuvant therapy|
16351563|NCT00253526|Procedure|anti-cytokine therapy|
16351564|NCT00253526|Procedure|antiangiogenesis therapy|
16351565|NCT00253526|Procedure|antibody therapy|
16351566|NCT00253526|Procedure|biological therapy|
16351581|NCT00253487|Procedure|adjuvant therapy|
16351582|NCT00253487|Procedure|autologous bone marrow transplantation|
16351583|NCT00253487|Procedure|conventional surgery|
16351584|NCT00253487|Procedure|peripheral blood stem cell transplantation|
16351585|NCT00253487|Radiation|radiation therapy|
16351586|NCT00253474|Biological|PEG-interferon alfa-2a|
16351587|NCT00253461|Procedure|computed tomography|Within 4 weeks after initial imaging, patients also undergo a CT scan.
16351588|NCT00253461|Procedure|positron emission tomography|"Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan.
~Phase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan."
16351589|NCT00253461|Radiation|11C topotecan|Phase I and II: IV over 10 minutes
16351590|NCT00253461|Radiation|fludeoxyglucose F 18|Phase II: fludeoxyglucose F 18 IV
16351591|NCT00253448|Radiation|radiation therapy|No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
16351592|NCT00253448|Radiation|stereotactic radiosurgery|stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
16351593|NCT00253435|Biological|Filgrastim|Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. The first dose should begin four hours after the stem cell infusion is completed. Filgrastim will continue daily until the ANC >=1500/uL for three consecutive days.
16351594|NCT00253435|Drug|Carboplatin|"The carboplatin will be administered as a continuous IV infusion Day - 7 through Day - 4, with dosing based upon pretreatment GFR levels. The carboplatin should be diluted to a concentration of 0.3 mg/ml in D5W 0.45NS and infused concomitantly with etoposide through the same central venous catheter using a Y connector; a controlled rate infusion pump is used for each arm of the Y."
16351595|NCT00253435|Drug|Etoposide|The etoposide shall be administered day -7 through day -4 via continuous intravenous infusion over 96 hours. For patients with a corrected GFR >= 100 ml/min/1.72 m^2, a dose of 300 mg/m^2/day (10 mg/kg/day if child is < 12 kg) shall be given. For patients with a corrected GFR 60-99 ml/min/1.72 m^2, the etoposide will be administered at a dose of 160 mg/m^2/day (5.3 mg/kg/day). The etoposide will be diluted in D5W 0.45%NS at a concentration of < 0.4 mg/ml. Etoposide should not be mixed with carboplatin, but administered using a Y-connector.
16351596|NCT00253435|Drug|Melphalan|For patients in either the normal GFR strata (>=100 ml/min/1.73 m^2), or reduced GFR strata (60-99 ml/min/1.73m^2), melphalan shall be administered at a dose of 60 mg/m^2/day (2 mg/kg/day if child is < 12 kg) on day -7, -6, and -5 of study. The melphalan should be infused at a rate of less than 10 mg/minute, and should complete within 1 hour of reconstitution each day. The melphalan should be diluted in 0.9% NaCl at a concentration < 2 mg/ml. The total dosage of melphalan to be administered will be 180 mg/m^2.
16351597|NCT00253435|Procedure|Peripheral blood stem cell infusion|Stem cells or marrow will be infused on day 0 of study therapy. Where the DMSO concentration in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over two days to meet this standard. For purged PBSC: A minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. For unpurged PBSC, a minimum of 2.0 x 10^6 viable CD34+ cells/kg must be available. Having a back-up of 2.0 x 10^6 viable CD34+ cells/kg purged or unpurged PBSC is recommended but not required. For purged bone marrow, a minimum of 1.5 x10^8 mononuclear cells/kg must be available.
16351598|NCT00253435|Radiation|131I-MIBG|Therapeutic 131I MIBG will be synthesized by Draximage Canada.with specific activity between 15 and 25mCi/ml. Radiopurity will be initially determined by Draximage, prior to shipment to participating centers. Free radioiodide content must then be rechecked at the treating center prior to infusion using HPLC or Sep-Pac methodology.
16351599|NCT00253435|Radiation|Radiation therapy|Local irradiation is to be given to previously non-irradiated primary and metastatic sites of disease. Local irradiation should not start till the patient is medically stable, has an ANC > 1000/uL, platelets > 30,000 / uL, and is > 42 days post transplant. Recommended radiation guidelines consist of 2160 cGy total, given over 12 days using a single 180 cGy fraction/day. Any delay in local radiation that would extend treatment beyond day +84 should be discussed with the study chair. Local radiation will be administered at a participating NANT member site.
16351600|NCT00253422|Drug|anastrozole|
16351601|NCT00253422|Drug|exemestane|
16351602|NCT00253422|Drug|fulvestrant|
16351603|NCT00253409|Drug|chemotherapy|
16351604|NCT00253409|Procedure|adjuvant therapy|
16351605|NCT00253409|Procedure|conventional surgery|
16351606|NCT00253409|Procedure|neoadjuvant therapy|
16351607|NCT00253409|Radiation|radiation therapy|
16351608|NCT00253396|Drug|Unfractionated heparin|
16351609|NCT00253396|Drug|Enoxaparin|
16351610|NCT00253383|Other|counseling intervention|
16351611|NCT00253383|Other|educational intervention|
16351612|NCT00253383|Procedure|psychosocial assessment and care|
16351613|NCT00253383|Procedure|quality-of-life assessment|
16351614|NCT00253370|Drug|BAY 43-9006|Given orally
16351615|NCT00253370|Drug|docetaxel|Given IV
16351616|NCT00253370|Drug|cisplatin|Given IV
16351617|NCT00253344|Drug|docetaxel|Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
16351618|NCT00253344|Drug|lenalidomide|Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.
16351619|NCT00253331|Drug|topical organogel with nitroglycerin|
16351620|NCT00253318|Drug|Docetaxel|40 mg/m^2 IV over 1 hour on Day 1.
16351621|NCT00253318|Drug|RAD001|30 mg orally on Days 1 and 8.
16351622|NCT00253318|Drug|Dexamethasone|8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel.
16351623|NCT00253305|Drug|Organogel of naftifine, 2%|
16351624|NCT00253305|Drug|Organogel of terbinafine, 2%|
16351625|NCT00253305|Drug|Organogel of naftifine, 6%|
16351626|NCT00253305|Drug|Organogel of terbinafine, 6%|
16351627|NCT00253279|Procedure|PET Scans|Healthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c.
16351628|NCT00253266|Drug|Venlafaxine|Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
16351629|NCT00253266|Drug|Quetiapine|Quetiapine up to 200 mg/d for four weeks
16351632|NCT00253227|Drug|galantamine hydrobromide|
16351633|NCT00253214|Drug|galantamine hydrobromide|
16351634|NCT00253201|Drug|galantamine hydrobromide|
16351635|NCT00253188|Drug|galantamine hydrobromide|
16351636|NCT00253175|Drug|topiramate|
16351637|NCT00253162|Drug|risperidone|
16351638|NCT00253149|Drug|risperidone|
16351639|NCT00253136|Drug|risperidone|
16351640|NCT00253123|Drug|risperidone|
16351641|NCT00253110|Drug|risperidone|
16351642|NCT00253110|Drug|haloperidol|
16351643|NCT00253097|Behavioral|Intervention|Patients allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate
16351644|NCT00253084|Drug|IPX054 200 mg|IPX054 containing 50 mg carbidopa and 200 mg levodopa
16351645|NCT00253084|Drug|CD-LD IR|CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
16351646|NCT00253084|Drug|IPX054 Placebo|Placebo to match IPX054 200 mg
16351647|NCT00253084|Drug|CD-LD IR Placebo|Placebo to match CD-LD IR
16351648|NCT00253071|Behavioral|Prophylactic combined medical and psychological treatment|"Medical treatment is naturalistic and evidence based according to international recommendations.
~Psychological treatment is either group psychoeducation or group cognitive behavioural therapy."
16351649|NCT00253058|Drug|Cetirizine Dry Syrup|
16351650|NCT00253045|Behavioral|Motivational groups|Motivational interviewing in group format
16351651|NCT00253032|Device|PRIMA|
16351652|NCT00253006|Procedure|Tissue examination for protein- and mRNA-expression of NO|
16351653|NCT00252993|Drug|DDP225|
16351654|NCT00252980|Behavioral|Psychotherapy|
16351655|NCT00252967|Drug|Atorvastatin|80 mg of Atorvastatin
16351656|NCT00252967|Drug|Placebo|
16351657|NCT00252954|Drug|Levetiracetam|Tablets 2000-3000 mg per day
16351658|NCT00252941|Device|Memokath 028SW Urethral Stent|
16351659|NCT00252928|Other|Sodium dichloroisocyanurate (NaDCC) tablets|Intervention arm receives NaDCC tablets to use for to disinfect their household water for use for 20L of water. Ideally, disinfection occurs every day.
16351660|NCT00252928|Other|Placebo|Placebo
16351661|NCT00252915|Biological|GM-CSF (verum)|sagramostim
16351662|NCT00252902|Behavioral|Behavior change counseling|
16351663|NCT00252889|Drug|Topotecan and pegylated doxorubicin|Doxil 40 mg/m2 day 1 and topotecan was to be escalated in cohorts of patients
16351664|NCT00252876|Drug|tesaglitazar|
16351665|NCT00252863|Drug|Symbicort, used twice daily (b.i.d) and as needed (prn)|
16351666|NCT00252863|Drug|Budesonide Turbuhaler 200 µg|
16351667|NCT00252863|Drug|Fluticasone Discus 250 µg|
16351668|NCT00252863|Drug|Formoterol Turbuhaler 4.5 µg|
16351669|NCT00252863|Drug|Terbutaline Turbuhaler 0.5 mg|
16351670|NCT00252863|Drug|Salbutamol pressurized metered dose inhaler (pMDI) 100 µg|
16351671|NCT00252863|Drug|Salmeterol Discus 50 µg|
16351672|NCT00252863|Drug|Budesonide/Formoterol Turbuhaler 160/4.5 µg|
16351673|NCT00252863|Drug|Fluticasone/Salmeterol Discus 250/50 µg|
16351674|NCT00252863|Drug|Fluticasone/Salmeterol Discus 500/50 µg|
16351675|NCT00252863|Drug|Theophylline 200 mg|
16351676|NCT00252863|Drug|Theophylline 300 mg|
16351677|NCT00252863|Drug|Singulair 10 mg|
16351678|NCT00252850|Genetic|CERE-120: AAV2-NTN|
16351679|NCT00252837|Drug|Tesaglitazar|
16351680|NCT00252837|Behavioral|Dietary and Lifestyle counseling|
16351681|NCT00252824|Drug|Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy|
16351682|NCT00252811|Drug|Gefitinib|
16351683|NCT00252798|Drug|Gefitinib|
16351684|NCT00252798|Drug|Carboplatin|
16351685|NCT00252798|Drug|Paclitaxel|
16351686|NCT00252798|Procedure|Radiation|
16351687|NCT00252785|Drug|Budesonide/Formoterol|
16351688|NCT00252785|Drug|Budesonide|
16351689|NCT00252785|Drug|Theophylline|
16351690|NCT00252772|Drug|Tesaglitazar|
16351691|NCT00252772|Behavioral|Dietary and Lifestyle counseling|
16351692|NCT00252746|Drug|ZD6474 (vandetanib) 100mg|once daily oral dose
16351693|NCT00252746|Drug|ZD6474 (vandetanib) 200mg|once daily oral dose
16351694|NCT00252746|Drug|ZD6474 (vandetanib) 300mg|once daily oral dose
16351695|NCT00252733|Drug|candesartan cilexetil|32 mg once daily oral tablet given over 60 months
16351696|NCT00252720|Drug|candesartan|32 mg oral tablet
16351697|NCT00252707|Drug|Gefitinib or Docetaxel|
16351698|NCT00252694|Drug|candesartan|32 mg oral tablet
16351699|NCT00252681|Procedure|laparotomy|
16351700|NCT00252681|Procedure|primary peritoneal drainage|
16351701|NCT00252668|Drug|Etanercept|
16351702|NCT00252668|Drug|Methotrexate|
16351703|NCT00252655|Drug|Rapamune and Prograf|
16351704|NCT00252642|Drug|Peginterferon Alpha-2a|
16351705|NCT00252629|Other|Nasal CPAP treatment during sleep|After documenting sleep disordered breathing, GWS subject gets randomized to receive either a therapeutic nasal CPAP or a sham nasal CPAP treatment during sleep, GWS symptoms ( fatigue, pain, and cognitive dysfunction) were assessed by a baseline questionnaires and at 3 week period whether on sham or therapeutic CPAP. The change of symptoms in each group will be compared.
16351706|NCT00252616|Behavioral|trophic enteral feeds|10cc/hr
16351707|NCT00252603|Drug|Galantamine|
16351708|NCT00252590|Behavioral|Health Motivational Feedback|Personalized feedback on health status
16351709|NCT00252590|Behavioral|Health Education|Generalized health education related to alcohol use
16351710|NCT00252590|Behavioral|Control - treatment as usual|Control group with no additional intervention
16351763|NCT00252148|Biological|ADMVA|experimental HIV vaccine, MVA vector expressing HIV clade C env, gag, pol, nef, and tat
16351764|NCT00252122|Drug|Ketamine|Ketamine. 0.2 mg/kg, intravenously
16351711|NCT00252577|Drug|Lithium treatment|Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
16351712|NCT00252564|Drug|Bevacizumab|5 mg/kg over 30 minutes on Days 1 and 15
16351713|NCT00252564|Drug|Oxaliplatin|85 mg/m2 on Days 1 and 15
16351714|NCT00252564|Drug|Leucovorin|400 mg/m2 on Days 1 and 15
16351715|NCT00252564|Drug|Fluorouracil|400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
16351716|NCT00252564|Drug|Cetuximab|400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour
16351717|NCT00252551|Procedure|Osteosynthesis|
16351718|NCT00252551|Procedure|Simple surgery|Surgery without device
16351719|NCT00252512|Behavioral|Contingency Management|Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
16351720|NCT00252512|Other|Placebo|Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
16351721|NCT00252499|Drug|rosiglitazone|PPAR-gamma agonist, insulin sensitizer
16351722|NCT00252499|Drug|fenofibrate|PPAR-alpha agonist, reduces triglycerides
16351723|NCT00252499|Drug|placebo for rosiglitazone|placebo tablets that are matched to look like rosiglitazone
16351724|NCT00252499|Drug|placebo for fenofibrate|placebo matched to look like fenofibrate tablets
16351725|NCT00252486|Drug|Flax oil|Flax oil and olive oil placebo were analyzed for quality and purity; sufficient bioactivity was confirmed for the flax oil independently at the University of Massachusetts mid-way through the study. Each capsule of omega -3 fatty acid concentrate contained 550 mg of α-linolenic acid (α-LNA) from flax seed oil.A stepped but flexible dose-titration schedule was carried out with doses increased by 1-2 grams at each visit as tolerated, to an attempted total dose of 6 capsules twice per day, as requested by the FDA (up to 6.6 grams of daily α-linolenic acid).
16351726|NCT00252473|Device|MedTec S-frame Immobilization Masks|
16351727|NCT00252460|Device|Computed Tomography Scan and Magnetic Resonance Imaging|
16351728|NCT00252447|Procedure|Pre-Operative Conformal Radiotherapy|
16351729|NCT00252434|Behavioral|Cognitive Behavioral Therapy Development for Methamphetamine Abuse|
16351730|NCT00252421|Drug|Nitroglycerin ointment 15 mg/day daily for 24 month|Nitroglycerin ointment 15 mg/day applied daily for 24 mth
16351731|NCT00252421|Drug|Placebo ointment daily for 24 month|Placebo ointment applied daily for 24 mth
16351732|NCT00252408|Drug|Hormone replacement therapy|
16351733|NCT00252395|Device|PDA-based Electronic Prescribing Software|
16351734|NCT00252382|Drug|SNS-595 Injection|Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.
16351735|NCT00252369|Drug|Infliximab|
16351736|NCT00252369|Procedure|Instillation of fibrin glue|
16351737|NCT00252356|Drug|SR58611A|
16351738|NCT00252343|Drug|SR58611A|
16351739|NCT00252330|Drug|SR58611A|
16351740|NCT00252317|Drug|Captopril and Trandolapril|Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
16351741|NCT00252317|Drug|Captopril Test Dose and Trandolapril|Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
16351742|NCT00252304|Drug|Zinc (zinc sulphate)|Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
16351743|NCT00252304|Drug|Placebo|Placebo
16351744|NCT00252291|Drug|Aridol|
16351745|NCT00252291|Drug|Methacholine|
16351746|NCT00252291|Procedure|Exercise challenge|
16351747|NCT00252278|Drug|atomoxetine|
16351748|NCT00252252|Device|VPAP non-invasive ventilator|
16351749|NCT00252252|Device|AutoVPAP non-invasive ventilator|
16351750|NCT00252239|Drug|tenecteplase|This study will compare 3 different doses of tenecteplase to tPA.
16351751|NCT00252239|Drug|tissue plasminogen activator, tPA|To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
16351752|NCT00252226|Drug|Quetiapine|
16351753|NCT00252213|Drug|Human BNP|
16351754|NCT00252200|Drug|Neseritide|Dose of Nesiritide infusion will be 0.005 ug/Kg/min
16351755|NCT00252187|Drug|B-type Natriuretic Peptide (BNP)|BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
16351756|NCT00252187|Other|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
16351757|NCT00252174|Drug|Stage 1 Active Methylenedioxymethamphetamine|"Dosage form: capsule
~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
16351758|NCT00252174|Drug|Stage 1 Low dose Methylenedioxymethamphetamine|"Drug:
~Dosage form: capsule
~Dosage frequency and duration for the control arm (4 subjects):
~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
16351759|NCT00252174|Behavioral|Psychotherapy|Psychotherapy conducted with low or active dose MDMA
16351760|NCT00252174|Drug|Stage 2 Active Methylenedioxymethamphetamine|"Administered open label Dosage form: capsule
~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):
~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
16351761|NCT00252161|Procedure|Gastrectomy with more than D2 dissection|Gastrectomy with more than D2 dissection
16351762|NCT00252161|Drug|Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy|Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
16351765|NCT00252109|Behavioral|Popular Opinion Leader|Popular opinion leaders of social networks are identified and attend 4 sessions to prepare them to have casual conversations with persons in the social networks that are meant to shift social norms to embrace safer behaviors (e.g., increased condom use, fewer sexual partners)
16351766|NCT00252096|Device|Nucleic acid amplification test|
16351767|NCT00252083|Behavioral|Popular Opinion Leader|
16351768|NCT00252070|Behavioral|Functional Exercise for People with Arthritis (FEPA)|
16351769|NCT00252057|Behavioral|Re-Engineered Hospital Discharge|"The Re-engineered Hospital Discharge (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist."
16351770|NCT00252044|Drug|Pergolide|
16351771|NCT00252031|Behavioral|Dialectical Behavioral Therapy|
16351772|NCT00252018|Behavioral|Daily intake of broccoli sprouts|
16351773|NCT00252005|Drug|Apixaban|
16351774|NCT00251992|Drug|Esomeprazole|
16351775|NCT00251979|Drug|Esomeprazole|
16351776|NCT00251966|Drug|Esomeprazole|
16351777|NCT00251953|Drug|Tesaglitazar|
16351778|NCT00251953|Drug|Metformin|
16351779|NCT00251940|Drug|Tesaglitazar 0.5 or 1 mg|
16351780|NCT00251940|Drug|Glibenclamide 2.5, 5, 10 or 15 mg|
16351781|NCT00251927|Drug|esomeprazole|40 mg oral tablet administered daily
16351782|NCT00251927|Procedure|Laparoscopic fundoplication (surgery)|Surgery
16351783|NCT00251914|Drug|Esomeprazole|
16351784|NCT00251901|Drug|Esomeprazole|
16351785|NCT00251888|Drug|campto (irinotecan)|
16351786|NCT00251888|Drug|cisplatin (cisplatyl)|
16351787|NCT00251875|Device|online health information journal|
16351788|NCT00251862|Behavioral|Web-based decision aid plus personalized risk assessment|Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.
16351789|NCT00251862|Behavioral|Web-based decision aid alone|Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.
16351790|NCT00251862|Behavioral|Generic website|Patients review a generic website that discuss ways to reduce overall cancer risk.
16351791|NCT00251849|Drug|Rifalazil|
16351792|NCT00251836|Procedure|Laparoscopic hand-assisted donor nephrectomy|
16351793|NCT00251823|Drug|Eptifibatide facilitated PCI|
16351794|NCT00251810|Device|Cerebral State Monitor|All patients monitored with BIS and CSM, results hidden for the anesthesiologist.
16351795|NCT00251797|Drug|Irinotecan|Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days
16351796|NCT00251797|Drug|Thalidomide|Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle
16351797|NCT00251784|Drug|Sildenafil|
16351798|NCT00251771|Procedure|catheter-directed venous thrombolysis|catheter-directed continuous intravenous infusion of alteplase 0.01mg/kg/h and low-dose heparin. Max dose 20mg/24 h and up to 96 hrs.
16351799|NCT00251758|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
16351800|NCT00251758|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
16351801|NCT00251758|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
16351802|NCT00251745|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
16351803|NCT00251745|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
16351804|NCT00251745|Drug|Placebo|Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
16351805|NCT00251732|Drug|Standard dose (once daily) PPI plus low-dose antidepressant|20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
16351806|NCT00251732|Drug|Double dose PPI plus evening placebo|20 mg. twice daily with a placebo
16351807|NCT00251732|Drug|Rabeprazole , placebo, placebo|20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
16351808|NCT00251719|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
16351809|NCT00251719|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
16351810|NCT00251719|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
16351811|NCT00251706|Drug|amiodarone|
16351812|NCT00251693|Drug|Dexlansoprazole MR|Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
16351813|NCT00251693|Drug|Dexlansoprazole MR|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
16351814|NCT00251693|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
16351815|NCT00251680|Drug|Lapaquistat acetate and lipid-lowering therapy|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
16351816|NCT00251680|Drug|Lipid-lowering therapy|Lapaquistat acetate placebo-matching tablets, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
16351817|NCT00251654|Procedure|perineural block (anesthesia)|continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days
16351818|NCT00251641|Drug|infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
16351819|NCT00251641|Drug|methotrexate|Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
16351820|NCT00251628|Other|Standard Care|standard care
16351821|NCT00251628|Other|ATC Dosing|ATC dosing of a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours around-the-clock for the first 3 days following surgery
16351822|NCT00251628|Other|Structured Pain Management Program|The structured pain management program consisted of a nurse coaching intervention which included an evaluation of the child's current condition, review of the pain intensity scores, verification that the child was taking the pain medication, re-education regarding the rationale for ATC dosing, review of strategies to facilitate medication administration, and re-education about potential side effects associated with analgesic administration.
16351823|NCT00251628|Other|As needed dosing|"As needed analgesic dosing with a weight-appropriate dose of a nonopioid/opioid combination analgesic, every 4 hours as needed for pain."
16351824|NCT00251602|Drug|Atropine|One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
16351825|NCT00251602|Drug|Propranolol|One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
16351826|NCT00251602|Drug|Normal Saline|One-time 0.25 ml/min infusion over 30 minutes
16351827|NCT00251589|Drug|Vorinostat|Vorinostat 200 mg twice a day for 3 days a week.
16351828|NCT00251589|Drug|Vorinostat|Vorinostat 300 mg once a day for 3 days a week.
16351829|NCT00251589|Drug|Vorinostat|Vorinostat 300 mg twice a day for 3 days a week.
16351830|NCT00251589|Drug|Vorinostat|Vorinostat 400 mg once a day for 21 out of 28 days.
16351831|NCT00251589|Drug|erlotinib|erlotinib 150 mg once a day.
16351832|NCT00251576|Drug|A-Phase: tirofiban; Z-Phase simvastatin|
16351833|NCT00251576|Drug|Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years|
16351834|NCT00251576|Drug|Comparator: A-Phase: low molecular weight heparin, unfractionated heparin|
16351835|NCT00251576|Drug|Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours|
16351836|NCT00251576|Drug|Duration of Treatment: Z-Phase, 2 years.|
16351837|NCT00251550|Drug|Pemetrexed|
16351838|NCT00251550|Drug|Cisplatin|
16351839|NCT00251537|Drug|LTB4|
16351840|NCT00251524|Drug|Bevacizumab, Oxaliplatin, Pemetrexed|Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours
16351841|NCT00251511|Drug|Arsenic Trioxide|
16351842|NCT00251498|Drug|Cetuximab|Cycle 1:400 mg/m2, administered as a 120-minute iv infusion on Day 1 and 250 mg/m2 administered as a 60-minute iv infusion on Days 8 and 15, subsequent cycles:250 mg/m2 administered as a 60-minute iv infusion on Days 1, 8, 15
16351843|NCT00251485|Drug|Cetuximab|Cycle 1: 400 mg/m2 (given as a 2-hour infusion) on Day 1, then 250 mg/m2, Day 8 (given as a 1-hour infusion) subsequent cycles:250 mg/m2, Day 1 and Day 8 (given as a 1-hour infusion)
16351844|NCT00251472|Drug|Paclitaxel Albumin Nanoparticle for Injectable Suspension|125mg/m2 by 30-minute IV infusion, once a week.
16351845|NCT00251459|Drug|rhuFab V2 (ranibizumab)|
16351846|NCT00251446|Drug|Vinflunine|320 mg/m2 as a 20-minute IV infusion
16351847|NCT00251433|Drug|lapatinib, docetaxel, trastuzumab|The phase I part of the study will include cohorts of 3 patients to investigate doses of lapatinib (750mg, 1000mg, 1250mg, 1500mg) with 75mg/m2 3- weekly docetaxel plus standard weekly doses of trastuzumab with prophylactic use of growth factors in all patients. Further cohorts may be explored with prophylactic use of growth factors at the doses stipulated in the phase I dose escalation schema
16351848|NCT00251433|Drug|Docetaxel, trastuzumab|For Phase II, subjects will be pre-stratified for Eastern Cooperative Oncology Group (ECOG) performance (0 vs. 1; see Appendix 4 ) and site of disease (visceral vs. non-visceral). Subjects will then be randomised in a 2:1 ratio to receive either the triplet regimen or the docetaxel and trastuzumab combination.
16351849|NCT00251420|Procedure|writing about disease|writing about physical or emotional consequences of pulmonary disease
16351850|NCT00251407|Drug|Taxotere|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
16351851|NCT00251407|Drug|Cisplatin|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
16351852|NCT00251407|Drug|CPT-11|Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
16351853|NCT00251394|Drug|Rituxan|Given intravenously once weekly for four weeks.
16351854|NCT00251394|Drug|1018 ISS|Given as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.
16351855|NCT00251381|Drug|Cetuximab|
16351856|NCT00251368|Drug|9-Aminocamptothecin (9-AC)|
16351857|NCT00251355|Drug|Gemcitabine|Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.
16351858|NCT00251355|Drug|5-Fluorouracil|5-FU via continuous IV infusion.
16351859|NCT00251355|Procedure|Radiation Therapy|External Beam Radiotherapy (weeks 1-6), Monday through Friday.
16351860|NCT00251342|Procedure|Edinburgh Postnatal Depression Scale|
16351861|NCT00251329|Drug|neoadjuvant chemotherapy|
16351862|NCT00251316|Drug|Lithium Carbonate|30 mCi of 131I
16351863|NCT00251316|Drug|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
16351864|NCT00251303|Drug|Riluzole|Active drug put into 10-mg capsules by NIH Clinical Center Pharmacy. Matched placebo capsules were also prepared by NIH Clinical Center Pharmacy. Dose up to 120 mg daily, divided into bid dosages.
16351865|NCT00251303|Drug|Placebo|Capsules matched active drug in appearance.
16351866|NCT00251290|Procedure|auto-titrating continuous positive airway pressure|Continuous positive Airway pressure (CPAP) use for 90 days post TIA
16351867|NCT00251277|Drug|Rituximab|Rituximab will be administered immediately after pheresis to minimize the amount of Rituximab that is removed by the subsequent days pheresis. The guidelines will be that 12 hours must elapse between the end of the first infusion of study drug and the next pheresis. Subsequent infusions would be weekly (plus or minus 2 days) with an attempt made to give study drug infusions after a pheresis that might be the last in a series, i.e. when no pheresis would be scheduled for at least the next day.
16351868|NCT00251264|Procedure|Open stabilization|"Following examination under anesthesia, a 5cm standard deltopectoral incision is made. Dissection is continued exploiting the deltopectoral internervous plane. The conjoined tendon is retracted medially. The underlying subscapularis tendon is identified and incised horizontally or split vertically in its midsubstance. If required for adequate exposure, the subscapularis split may be extended by incising the inferior component of the subscapularis tendon near its insertion on the lesser tuberosity. The shoulder is entered by performing a T shaped arthrotomy with retractors for full exposure of the glenoid. Shoulder pathology is addressed with suture anchor repair of any capsulolabral detachment (ie.Bankart lesion) and/ or a capsular plication for repair of capsular redundancy."
16351869|NCT00251264|Procedure|Arthroscopic stabilization|With the examination under anesthesia completed, the arthroscope is introduced through a standard posterior arthroscopy portal. A diagnostic arthroscopy is performed and the intraarticular pathology identified and documented. Any labral detachment (i.e. Bankart lesion) is repaired using suture anchor fixation and arthroscopic tying techniques. Capsular redundancy is addressed with the use of thermal electrocapsulorrhaphy or arthroscopic suture repair of the redundant capsule. With the repair complete, 40 cc of 0.5% Bupivicaine is introduced into the joint. A sterile dressing is applied over the wounds and the operated shoulder placed in a shoulder immobilizer.
16351870|NCT00251251|Device|Optimal Medical Therapy plus ICD|ICD vs CRT/ICD
16351871|NCT00251251|Device|Optimal Medical Therapy plus CRT/ICD|ICD vs CRT/ICD
16351872|NCT00251238|Drug|Ginkgo biloba extract EGb 761|daily Ginkgo biloba extract EGb 761
16351873|NCT00251225|Drug|Gleevec|Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m^2 administered IV
16351874|NCT00251225|Drug|Docetaxel|60 mg/m^2 administered IV on day 0
16351875|NCT00251212|Behavioral|Adapted Motivational Interviewing & Skills Training|Single session, 45 minute brief intervention during Emergency Department Visit
16351876|NCT00251199|Drug|VX-950|
16351877|NCT00251199|Drug|peginterferon|
16351878|NCT00251186|Drug|Capecitabine and Cetuximab|
16351879|NCT00251173|Behavioral|Strengths Based Case Management (SBCM)|
16351880|NCT00251173|Behavioral|Motivational Enhancement Therapy (MET)|
16351881|NCT00251173|Behavioral|Brief Informational Feedback (BIF) session|
16351882|NCT00251160|Procedure|Electrothermal arthroscopic capsulorrhaphy (ETAC)|The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) delivers heat at 75C and 40 watts. An anterior portal is established above the superior border of the subscapularis tendon. For MDI patients, the heat probe is introduced through the posterior portal. The capsule is shrunk using a grid pattern until excess volume is diminished. The extent of the heat probe application is identical to the landmarks used for the open ICS. Care is taken to avoid applying heat to the capsule in the region from 5-7 o'clock within 1cm of the glenoid rim to avoid the axillary nerve. The method of heat application utilizes a grid pattern, which is less likely to cause dissolution of the capsule and subsequent catastrophic capsular loss.
16351883|NCT00251160|Procedure|Open inferior capsular shift (ICS)|MDI: lateral capsule released antero-superiorly from rotator interval to equator, posteriorly on the humeral neck. MDL-AII: release from the rotator interval to 7 o'clock (Right) or 5 o'clock (Left) position on humeral neck, to tighten the 2 bands of the inferior GH ligaments, middle GH ligament and rotator interval. Bone adjacent to the articular surface on the surgical neck of the humerus is roughened to create a bleeding bony bed. With the arm in 0deg flexion, 30deg abduction, 30deg external rotation, the inferior leaflet of the capsule is shifted superiorly and slightly laterally, and sutured to the rim of the capsule using a non-absorbable suture. Superior leaflet is shifted inferiorly and sutured. Subscapularis is repaired at its anatomic length using interrupted sutures.
16351884|NCT00251147|Procedure|Open acromioplasty with rotator cuff repair|A standard vertical incision was made over the anterolateral aspect of the acromion. The deltoid muscle was split and stripped off the anterior aspect of the acromion. The anterior and inferior aspect of the acromion was removed. The coracoacromial ligament was excised. Repair of the tear in the cuff tendon(s) was accomplished by suturing leading edge of the tear into the greater tuberosity of the humerus at or near the original site of insertion of the cuff to bone. Trans-osseous sutures, suture anchors and tendon to tendon suture repair techniques were employed for a secure repair with the arm at the side. The surgeon was allowed to use whatever method(s) to create a secure repair. The deltoid was securely reattached to the acromion with the deltoid fascia repaired down the split.
16351885|NCT00251147|Procedure|Arthroscopic acromioplasty with mini-open repair|A standard arthroscopic gleno-humeral arthroscopy was performed followed by an arthroscopic acromioplasty. Three standard arthroscopic portals were used. The lateral portal was centered in line with the cuff tear, and incorporated into the mini-open incision. Initially, a partial bursectomy was performed to improve visualization. The inferior surface of the anterior acromion and the coracoacromial ligament were removed. Following the arthroscopic acromioplasty, a 3-4cm lateral incision was performed in the area of the lateral portal. The deltoid muscle was split longitudinally to expose the tear in the rotator cuff. The tear was repaired in a similar manner to the open repair with tendon to tendon sutures, trans-osseous sutures and with suture anchors.
16351886|NCT00251134|Drug|Zodin (drug)|1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months
16351887|NCT00251134|Drug|Olive oil (placebo)|1 gram olive oil daily for a period of 12 months
16351888|NCT00251121|Other|Mini-invasive electrophysiological study|Transvenous pacing in right heart atrium
16351889|NCT00251121|Other|Atrial pacing|Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
16351890|NCT00251108|Procedure|Cardiorespiratory fitness training|
16351891|NCT00251095|Drug|Taxol|
16351892|NCT00251095|Drug|TOCOSOL Paclitaxel|100 mg/m2/week
16351893|NCT00251082|Drug|continuous combined estradiol and dydrogesterone|0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
16351894|NCT00251082|Drug|continuous combined estradiol and dydrogesterone|1 Mg Estradiol and 5 Mg Dydrogesterone
16351895|NCT00251082|Drug|Placebo|Placebo
16351896|NCT00251069|Drug|Glucosamine sulphate|
16351897|NCT00251056|Drug|mannitol|120mg BD
16351898|NCT00251056|Drug|mannitol|40 mg BD
16351899|NCT00251056|Drug|mannitol|240mg BD
16351900|NCT00251056|Drug|mannitol|400mg BD
16351945|NCT00250679|Drug|Placebo|Placebo nebule or placebo aerolizer
16352001|NCT00250081|Procedure|Regularly ongoing therapy|
16351901|NCT00251043|Behavioral|Interpersonal psychotherapy for depression in pregnancy|IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.
16351902|NCT00251043|Behavioral|Parenting education program (PEP)|PEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development.
16351903|NCT00251030|Drug|Nelfinavir and Omeprazole|
16351904|NCT00251017|Procedure|Vancomycin|Two hour creatinine clearance before and after vancomycin
16351905|NCT00251017|Procedure|DNA are extracted from the whole blood of subjects|
16351906|NCT00251004|Drug|Everolimus|oral, bis in diem/twice a day (bid)
16351907|NCT00251004|Drug|Mycophenolic Acid (MPA)|2 oral capsules of mycophenolic acid 360mg administered bid
16351908|NCT00251004|Drug|Cyclosporine A (CsA)|CsA dose adjustments were based on CsA trough levels (C0).
16351909|NCT00251004|Drug|Basiliximab|All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.
16351910|NCT00251004|Drug|Corticosteroids|Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.
16351911|NCT00250991|Drug|activase|
16351912|NCT00250991|Drug|integrilin|
16351913|NCT00250978|Drug|bevacizumab with chemotherapy, Pleur-XTM catheter placement|After Pleur-XTM catheter placement patients will receive bevacizumab 15mg/kg IV x 1 dose as a single agent.Three weeks later, chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab.
16351914|NCT00250965|Drug|intravenous magnesium|Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily.
16351915|NCT00250952|Drug|Botox Cosmetic™|
16351916|NCT00250939|Biological|Myozyme|20 mg/kg qow
16351917|NCT00250926|Drug|Bortezomib|Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
16351918|NCT00250926|Drug|Dexamethasone|Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
16351919|NCT00250926|Drug|Rituximab|Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
16351920|NCT00250913|Behavioral|Telephone-based physical activity counseling program|
16351921|NCT00250900|Behavioral|Prescription Fill Status|
16351922|NCT00250887|Drug|Gefitnib|
16351923|NCT00250874|Drug|Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab|
16351924|NCT00250861|Drug|Rituximab|
16351925|NCT00250861|Drug|Aldesleukin|
16351926|NCT00250835|Other|Chemotherapy, Celecoxib, and Radiation|Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment.
16351927|NCT00250822|Drug|Gemcitabine and Oxaliplatin|"Dose:
~Gemcitabine 1000 mg/m2 - IV in about 60 minutes on days 1 & 15. Oxaliplatin 100 mg/m2 - IV over 2hr on days 2 & 16"
16351928|NCT00250809|Procedure|Placement of a central venous catheter|Placement of a central venous catheter
16351929|NCT00250796|Drug|Thalidomide, alpha interferon|If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
16351930|NCT00250796|Drug|Thalidomide, interferon, Octreotide|If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
16351931|NCT00250744|Drug|Aprepitant vs. Gabapentin|Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
16351932|NCT00250744|Drug|Aprepitant vs. Gabapentin|Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.
16351933|NCT00250731|Behavioral|telephone support and behavior change|Diabetes self-management education provided over the telephone either for individuals or couples
16351934|NCT00250731|Other|Diabetes self-management education|Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
16351935|NCT00250718|Drug|Vincristine|Vincristine should be administered intravenously through a freely-running IV.
16351936|NCT00250718|Drug|VP-16|The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
16351937|NCT00250718|Drug|Rituximab|"The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.
~Patients will only receive rituximab if their tumors are CD20 positive CLL or NHL.
~Rituximab will only be administered to patients if they have previously had less than 8 doses. If a patient is treated with rituxan they should have at least 4 doses"
16351938|NCT00250718|Drug|Dexamethasone|Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
16351939|NCT00250718|Drug|Levofloxacin|Levofloxacin will be administered at 500 mg PO qd.
16351940|NCT00250705|Drug|Aripiprazole|The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
16351941|NCT00250692|Drug|Nitrous Oxide|
16351942|NCT00250679|Drug|Arformoterol tartrate inhalation solution|Arformoterol 15 ųg BID by nebulization
16351943|NCT00250679|Drug|Arformoterol 25 ųg BID|Arformoterol 25 ųg BID by nebulization
16351944|NCT00250679|Drug|Formoterol 12 ųg BID|Formoterol fumarate 12 ųg BID via aerolizer/DPI
16359258|NCT00186537|Drug|Rosiglitazone|
16351946|NCT00250666|Procedure|PCT measurement|Peripheral blood samples were collected in the morning, using vacuum tubes (BD Vacutainer SST II Plus plastic tubes; Becton Dickinson Diagnostic Systems, Allschwil, Switzerland). Circulating plasma PCT levels were measured with a time-resolved amplified cryptate emission technology assay (Kryptor PCT; Brahms AG, Hennigsdorf, Germany), with an assay sensitivity of 0.06 mg/L, approximately fourfold above mean normal levels. Measurements were performed 7 days a week.
16351947|NCT00250653|Drug|Saredutant succinate (SR48968C)|
16351948|NCT00250640|Drug|Iloprost (Ventavis, BAYQ6256)|The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
16351949|NCT00250627|Drug|Saredutant succinate (SR48968C)|
16351950|NCT00250614|Drug|Saredutant succinate (SR48968C)|
16351951|NCT00250601|Drug|Saredutant succinate (SR48968C)|
16351952|NCT00250588|Behavioral|Problem solving skills training|See description in Results
16351953|NCT00250588|Behavioral|Asthma care coordination|See description in Results
16351954|NCT00250588|Other|Usual Care|Usual clinical care
16351955|NCT00250575|Drug|Clozapine|
16351956|NCT00250562|Drug|valsartan plus hydrochlorothiazide|
16351957|NCT00250549|Behavioral|Post test video|We compared the educational effectiveness of a 15-minute posttest counseling video with the normal practice of a session with an HIV counselor.Patients in the experimental group watched an HIV posttest educational video.
16351958|NCT00250536|Drug|nandrolone decanoate|
16351959|NCT00250536|Behavioral|resistance exercise training|
16351960|NCT00250510|Behavioral|Simulated insurance reimbursement|Participants were told they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if they: 1) paid the fee in advance or committed 3 monthly payments in advance, 2) attended 10 of 12 class sessions, and 3) lost at least 6% of their current body weight during the program.
16351961|NCT00250497|Behavioral|New Moves|The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.
16351962|NCT00250484|Device|Transcranial Magnetic Stimulation|1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
16351963|NCT00250484|Device|Sham Transcranial Magnetic Stimulation|Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
16351964|NCT00250471|Procedure|Percutaneous Coronary Intervention (PCI)|
16351965|NCT00250458|Drug|Comparator: Rizatriptan|One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
16351966|NCT00250458|Drug|Comparator: Placebo|One dose matching placebo to Rizatriptan to treat one migraine attack.
16351967|NCT00250445|Drug|MK0663, etoricoxib|
16351968|NCT00250445|Drug|Comparator: Diclofenac sodium|
16351969|NCT00250432|Drug|caspofungin acetate|Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days.
16351970|NCT00250419|Biological|V930|
16351971|NCT00250406|Device|Ureteral Stent|triclosan-eluting ureteral stent
16351972|NCT00250406|Device|Ureteral Stent|Percuflex Plus Stent as the control
16351973|NCT00250393|Drug|Istradefylline (KW-6002)|
16351974|NCT00250367|Drug|risperidone|
16351975|NCT00250354|Drug|Risperidone oral solution|
16351976|NCT00250341|Drug|QVAR|480 mcg
16351977|NCT00250341|Drug|Advair|250/50 mcg
16351978|NCT00250341|Drug|Servent Diskus|50 mcg
16351979|NCT00250328|Device|LapCAC Laparoscopic Compression Anastomosis Clip|
16351980|NCT00250315|Drug|Dobutamine|
16351981|NCT00250302|Procedure|autologous mesenchymal stem cells implantation|
16351982|NCT00250289|Device|a mucosal sticker with herbal formula|
16351983|NCT00250276|Biological|Cervarix™|GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
16351984|NCT00250263|Drug|(agent for immunotherapy) Staloral|"Immunotherapy agent for sublingual daily use. First week (vial containing the concentration 10 IR/ml) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
~Second week (300 IR/ml) (vial containing the concentration 300 IR/ml) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
~Maintenance phase Day 12 to 364 - 8 pressures daily
~The first year will be followed by a second year open label period (optional)- 8 pressures daily"
16351985|NCT00250263|Drug|Placebo|"Matching placebo for sublingual use. Same schedule used for the intervention ACTIVE group.
~First week (vial containing placebo) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
~Second week (300 IR/ml) (vial containing placebo) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
~Maintenance phase Day 12 to 364 - 8 pressures daily"
16351986|NCT00250250|Drug|ZOMACTON|
16351987|NCT00250237|Drug|Haloperidol|Haloperidol 1mg twice daily during 72hours
16351988|NCT00250237|Drug|placebo|Placebo 1mg twice daily during 72hours
16351989|NCT00250224|Device|Radiotherapy stent|
16351990|NCT00250211|Procedure|Functional MRI imaging and tomotherapy|
16351991|NCT00250198|Drug|STA-5326|
16351992|NCT00250185|Drug|Sodium Nitrate|
16351993|NCT00250185|Drug|Acetylcholine|
16351994|NCT00250172|Drug|[C-11](R)-rolipram|
16351995|NCT00250146|Behavioral|Gluten (behaviour)|
16351996|NCT00250133|Procedure|Blood draws|
16351997|NCT00250120|Drug|L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin|delivery mode: inhalation
16351998|NCT00250094|Drug|Topotecan and VP16|"Course 1A: On day 1 treatment will start with a continuous infusion of TPT at 0.4 mg/m2/day for 21 days. A pump will be used to deliver the TPT. The bag in the pump will be replaced every week for sterility precautions.
~Course 1B: On day 28, if ANC is >1,500 and platelets > 100,000, VP-16 will be administered orally at 50 mg/day for 14 days."
16351999|NCT00250081|Procedure|Upper Extremity Tendon transfer|
16352000|NCT00250081|Procedure|Botulinum Toxin injections in Upper Extremity|
16352002|NCT00250068|Drug|Liposomal 9-Nitrocamptothecin|Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks
16352003|NCT00250055|Procedure|Colposcopy, Spectroscopy, and Biopsy|During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.
16352004|NCT00250042|Drug|Gleevec and Arsenic Trioxide|Pts. who fit the inclusion criteria, & were on imatinib, 400 mg/day, will be treated with a month of imatinib at 800 mg/d in divided doses (400mg bid) & then started on arsenic trioxide. Pts. already on imatinib 800 mg/day may be started on arsenic trioxide. Pts. unable to tolerate 800 mg/d should be treated at the max. dose tolerated above 400 mg/d. A total of 16 weeks of arsenic trioxide treatment will be administered (15 weeks of maintenance). Pts. are to continue on imatinib 800 mg/day,(or the max. tolerated dose) while receiving the arsenic trioxide. If a pt. has been taken off the arsenic trioxide, they should be continued on gleevec 800 mg per day (or the maximum tolerated dose) until there is evidence of progression of disease.
16352005|NCT00250029|Drug|Oxaliplatin|"Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion & the administration of any other drug.
~Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 & the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days."
16352006|NCT00250003|Behavioral|Preventive home visits|
16352007|NCT00249990|Drug|9-NC in aerosol reservoir|Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks (45-47).
16352008|NCT00249977|Drug|Capecitabine in Combination with Cisplatin and Irinotecan|"Cisplatin 50 mg/m2 on day 1 (course 1) or day 11 (subsequent courses) Irinotecan 50 mg/m2 on day 1, 8, and 15 (course 1) or day 11, 18 and 25 (subsequent courses).
~Capecitabine will be administered from day 1 to day 10 PO starting on course 2."
16352009|NCT00249964|Drug|Combination Treatment - Cohort 1|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 75 mg/m2 per day from day 2 to day 6."
16352010|NCT00249964|Drug|Combination Treatment - Cohort 2|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 100 mg/m2 per day from day 2 to day 6."
16352011|NCT00249964|Drug|Combination Treatment - Cohort 3|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 125 mg/m2 per day from day 2 to day 6."
16352012|NCT00249964|Drug|Combination Treatment - Cohort 4|"Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
~Temozolomide at 150 mg/m2 per day from day 2 to day 6."
16352013|NCT00249951|Drug|Alkaline citrate|Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.
16352014|NCT00249938|Drug|Minute Maid Heart Wise orange juice|
16352015|NCT00249938|Drug|Welchol|
16352016|NCT00249925|Behavioral|Home-Based Intervention|
16352017|NCT00249925|Behavioral|Multi-component home-based intervention|
16352018|NCT00249912|Drug|Lapaquistat acetate and rosuvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
16352019|NCT00249912|Drug|Lapaquistat acetate and rosuvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
16352020|NCT00249912|Drug|Rosuvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
16352021|NCT00249899|Drug|Lapaquistat acetate and stable statin therapy|Lapaquistat acetate 100 mg, tablets, orally, once daily and stable statin therapy for up to 24 weeks.
16352022|NCT00249899|Drug|Stable statin therapy|Lapaquistat acetate placebo-matching, tablets, orally, once daily and stable statin therapy for up to 24 weeks.
16352023|NCT00249886|Drug|Citalopram|
16352024|NCT00249873|Drug|clopidogrel (SR25990C)|oral administration (tablets)
16352025|NCT00249873|Drug|placebo|oral administration (tablets)
16352026|NCT00249860|Drug|Interferon-beta-1a|Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
16352027|NCT00249860|Drug|Placebo|Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
16352028|NCT00249860|Drug|Ribavirin plus Interferon-beta-1a|Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
16352029|NCT00249847|Drug|Paroxetine controlled-release|2-12.5 mg tablets, orally, every day for 4 weeks
16352030|NCT00249847|Drug|Conjugated equine estrogen|0.625 mg tablet, orally, every day for 4 weeks
16352031|NCT00249834|Drug|Gonal-f|GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.
16352032|NCT00249834|Drug|Recombinant human chorionic gonadotrophin (r-hCG)|When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
16352033|NCT00249821|Drug|Saizen®|Saizen® [somatropin (recombinant deoxyribonucleic acid [rDNA] origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
16352315|NCT00247039|Other|Placebo capsules|placebo capsules
16352034|NCT00249821|Drug|Saizen®|Saizen® [somatropin (rDNA origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
16352035|NCT00249808|Drug|Efalizumab - anti-CD11a recombinant human monoclonal antibody|Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
16352036|NCT00249795|Drug|Irbesartan|oral administration (tablets) once daily
16352037|NCT00249795|Drug|placebo|oral administration (tablets) once daily
16352038|NCT00249782|Drug|Vehicle control, 2x/day|
16352039|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 2x/day|
16352040|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 1x/day|
16352041|NCT00249782|Drug|MetroGel® (metronidazole gel), 1.0% 1x/day|
16352042|NCT00249782|Drug|ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)|
16352043|NCT00249769|Biological|Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)|Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.
16352044|NCT00249769|Biological|Measles Vaccine (MV)|"The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).
~SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979."
16352045|NCT00249756|Behavioral|Re-entry Modified Therapeutic Community (Re-entry MTC)|In general, the MTC program model applies three fundamental adjustments - increased flexibility, decreased intensity, and greater individualization. The central TC feature is retained; the MTC, like all TC programs, seeks to develop a subculture where clients learn through self-help and affiliation with the community to foster change in themselves and others. From this base (as elaborated below), further adaptations for the population of offenders with MICA disorders were incorporated to include an emphasis on modifying criminal thinking and behavior; on recognizing and responding to the interrelationship of substance abuse, mental illness, and criminality (triple recovery); and on using strategies for symptom management.
16352046|NCT00249756|Behavioral|Parole Supervision and Case Management|Recognizing the complexity of issues facing offenders returning to the community, and the importance of continuity of care, the CDOC established a system of aftercare substance abuse services for offenders on parole or placed in Community Corrections facilities. The statewide treatment options for the offenders consist of a network of community-based clinics and halfway houses throughout Colorado that provide substance abuse services and mental health services. Parole officers and Community Corrections case managers monitor treatment compliance to support participation in prescribed services.
16352047|NCT00249743|Device|FallSaver (formerly called NOCwatch)|
16352048|NCT00249730|Drug|Sildenafil|
16352049|NCT00249717|Behavioral|Contingency management|Receive rewards (prizes) abstinence and attendance
16352050|NCT00249704|Drug|Vitamin D + Sham Exercise|1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
16352051|NCT00249704|Procedure|Vitamin D Placebo + Exercise|Vitamin D placebo + Exercise
16352052|NCT00249704|Procedure|Vitamin D Placebo + Sham Exercise|Vitamin D placebo + Sham (equivalent to placebo) Exercise
16352053|NCT00249704|Drug|Vitamin D + Exercise|1000 IU per day of Vitamin D + Exercise
16352054|NCT00249691|Drug|Topiramate + Cognitive Behavioral Therapy|Topiramate up to 300 mg per day
16352055|NCT00249691|Drug|Placebo + Cognitive Behavioral Therapy|Placebo twice a day
16352056|NCT00249678|Behavioral|Behavior Therapy|
16352057|NCT00249652|Behavioral|TAP|12-session motivational interviewing-based telephone intervention.
16352058|NCT00249652|Other|TAU|The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
16352059|NCT00249639|Behavioral|Contingency management|Rewards valued $1-$100
16352060|NCT00249626|Behavioral|Contingency management|Rewards (prizes) for abstinence
16352061|NCT00249613|Behavioral|Women-Only|Gender-responsive treatment for women only
16352062|NCT00249600|Behavioral|Contingency management|
16352063|NCT00249587|Drug|Methadone|dosed to effect, every six hours
16352064|NCT00249574|Drug|Buprenorphine/naloxone|Human subjects HIV, HCV
16352065|NCT00249574|Drug|pegInterferon|intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.
16352066|NCT00249561|Behavioral|Recovery by Choice|"The experimental condition, the modified TC, was a 6- to 9-month program located in a separate 72-bed housing unit within the prison. Inmates progressed through four program stages with upper level inmates functioning as peer mentors for newer members. The modified, comprehensive TC treatment program focused on increasing awareness and understanding of female roles and relationships as they relate to addiction and drugs used and abused, and emotional and behavioral coping skills. Program elements addressed issues of substance abuse, relapse prevention, mental health, criminal thinking and behavior, coping with trauma and abuse, and parenting skills. All treatment staff received special training related to working with women exposed to trauma and abuse, making the program trauma informed and trauma sensitive."
16352316|NCT00247026|Drug|curcumin; coenzyme q10|
16352067|NCT00249561|Behavioral|The Intensive Outpatient Program (IOP)|The control condition, known at the prison as the Intensive Outpatient Program (IOP), was designed to address substance abuse and criminality, with a focus on prevention of relapse and recidivism. The IOP substance abuse treatment curriculum, designed for delivery over 15 weeks, consisted of a 90-hour manual-driven course (Strategies for Self-Improvement and Change, Wanburg & Milkman, 1998), which employed a cognitive behavioral format to address underlying issues of substance use/abuse and criminal behavior.
16352068|NCT00249548|Behavioral|Contingency management|
16352069|NCT00249535|Behavioral|Contingency management|Rewards (prizes) for abstinence
16352070|NCT00249522|Behavioral|Contingency management|
16352071|NCT00249509|Drug|Nefazodone|
16352072|NCT00249509|Drug|Bupropion|
16352073|NCT00249496|Behavioral|Contingency management|Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.
16352074|NCT00249496|Behavioral|Employment Only|Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
16352075|NCT00249483|Drug|Venlafaxine|Venlafaxiine 300mg/day
16352076|NCT00249483|Drug|Placebo|Placebo
16352077|NCT00249470|Behavioral|Abstinence & Work|Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
16352078|NCT00249470|Behavioral|Work Only|Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
16352079|NCT00249457|Behavioral|Contingency management|Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
16352080|NCT00249444|Drug|Mirtazapine|Mirtazapine
16352081|NCT00249444|Drug|Placebo|placebo
16352082|NCT00249431|Drug|Sertraline|Patients will be started on 25mg/day of Sertraline, and their dose will be increased to 50 mg/day by week two, and then weekly by 50mg/day based on clinical response and emergence of side effects. The maximum dose will be 200mg/day
16352083|NCT00249431|Behavioral|Relapse Prevention Therapy|Patients will have a weekly one-hour session for medication evaluation, relapse prevention therapy and answer questionnaires.
16352084|NCT00249418|Behavioral|Contingency management|Rewards (prizes) for abstinence
16352085|NCT00249405|Drug|Citalopram + MI|14-week citalopram treatment + Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
16352086|NCT00249405|Behavioral|Placebo + MI|placebo + single Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
16352087|NCT00249379|Drug|Acamprosate|Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
16352088|NCT00249366|Drug|Lorazepam (drug)|Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
16352089|NCT00249366|Drug|Lorazepam|Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
16352090|NCT00249353|Drug|methylphenidate hydrochloride|
16352091|NCT00249340|Behavioral|Weight Watchers|
16352092|NCT00249340|Behavioral|brief behavioral weight loss treatment|
16352093|NCT00249340|Behavioral|brief behavioral + Weight Watchers combined treatment|
16352094|NCT00249327|Behavioral|education|
16352095|NCT00249301|Drug|MLN8054|MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose strength expressed as the milligrams of active drug (free acid). MLN8054 will be given on an empty stomach. Patients will be instructed to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose.
16352096|NCT00249288|Drug|Folate|Folic acid taken as 2, 1mg capsule daily for 12 weeks
16352097|NCT00249288|Drug|Placebo|Placebo taken as 2, 1mg capsule daily for 12 weeks
16352098|NCT00249275|Device|spectacles|
16352099|NCT00249262|Drug|Taxoprexin|
16352100|NCT00249249|Drug|Pitavastatin|
16352101|NCT00249249|Drug|Atorvastatin|
16352102|NCT00249236|Drug|Risperidone, oral tablets|
16352103|NCT00249223|Drug|Risperidone Long acting injectable|
16352104|NCT00249210|Drug|levofloxacin|
16352105|NCT00249197|Drug|levofloxacin|
16352106|NCT00249171|Drug|risperidone|
16352107|NCT00249158|Drug|Risperidone|
16352108|NCT00249145|Drug|risperidone|
16352109|NCT00249132|Drug|risperidone|
16352110|NCT00249119|Drug|risperidone|
16352111|NCT00249106|Biological|ADVAX|
16352112|NCT00249093|Drug|oxygen|
16352113|NCT00249054|Device|ASR hip prosthesis|Implantation of resurfacing prosthesis
16352114|NCT00249054|Device|ReCap hip prosthesis|Implantation of resurfacing prosthesis
16352115|NCT00249041|Drug|50 mg Etanercept|50 mg Etanercept liquid injected SC once weekly using prefilled syringes
16352116|NCT00249041|Drug|Enbrel liquid|50 mg Etanercept liquid injected SC once weekly using prefilled syringes
16352117|NCT00249015|Behavioral|Physical exercise|perform exercise program 3 days per week and 5 minutes of warm-up and cool-down exercises before and after the main exercise component
16352118|NCT00249002|Drug|ABI-007|
16352119|NCT00248989|Drug|Dehydroepiandrosterone|3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
16352120|NCT00248989|Drug|Placebos|3.0 ml of placebo cream applied on the skin twice daily.
16359259|NCT00186537|Drug|Fenofibrate|
16352121|NCT00248976|Behavioral|Net-present value of individual health behaviors in years|
16352122|NCT00248963|Drug|Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg|
16352123|NCT00248950|Behavioral|Positive affect induction and /or self affirmation induction|
16352124|NCT00248937|Behavioral|Positive affect and self-affect induction|
16352125|NCT00248924|Behavioral|Social Services|
16352126|NCT00248911|Behavioral|Mindfulness based meditation program|Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
16352127|NCT00248898|Procedure|Cardiac Surgery|Coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, aortic aneurysm repair
16352128|NCT00248885|Procedure|Regulating Mean Arterial Pressure during cardiopulmonary bypass|Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.
16352129|NCT00248872|Behavioral|Intervention Group|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
16352130|NCT00248846|Behavioral|Intervention Group|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
16352131|NCT00248833|Biological|25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine|The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
16352132|NCT00248833|Biological|50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine|The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
16352133|NCT00248820|Procedure|Contrast-enhanced ultrasound|Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).
16352134|NCT00248807|Drug|1.25 mg enalaprilat IV|an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)
16352135|NCT00248807|Other|Head up tilt (HUT)|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.
16352136|NCT00248794|Behavioral|Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)|CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.
16352137|NCT00248794|Behavioral|Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)|ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.
16352138|NCT00248794|Behavioral|Skills Group (SDG)|Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.
16352139|NCT00248781|Device|Telecommunications system|
16352140|NCT00248781|Device|attention control|health education
16352141|NCT00248768|Device|Transcranial magnetic Stimulator|a device which produces intense magnetic fields in the brain and activates cerebral neurons
16352142|NCT00248755|Procedure|mucociliary clearance scan|
16352143|NCT00248742|Behavioral|Psychological behavioral intervention|3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
16352144|NCT00248729|Drug|Etomidate (20mg) or Midazolam (7mg)|
16352145|NCT00248716|Drug|Ferrous gluconate and iron polysaccharide complex|Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
16352146|NCT00248703|Drug|Docetaxel|Docetaxel 100 mg/m2 3 qw x 6
16352147|NCT00248690|Device|ICP mean wave amplitude|Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
16352148|NCT00248677|Behavioral|Behavioral Family-Based Intervention|Behavioral family intervention
16352149|NCT00248677|Behavioral|Behavioral Parent-Based Intervention|Behavioral Parent-Only Intervention
16352150|NCT00248651|Drug|Amitriptyline|25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.
16352151|NCT00248651|Drug|Escitalopram|10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
16352152|NCT00248651|Drug|Placebo|Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
16352153|NCT00248638|Drug|Glutamine dipeptide with 15% Clinisol|Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.
16352154|NCT00248638|Drug|15% Clinisol|Subjects randomized to STD-PN will receive 1.5 g/kg/day of 15% Clinisol. The amount of Clinisol administered each day will be determined by daily PN volume intake data.
16352317|NCT00247013|Behavioral|Breast Cancer Screening Compliance|
16352155|NCT00248625|Drug|N-acetylcysteine|The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
16352156|NCT00248625|Drug|Placebo|Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
16352157|NCT00248612|Drug|Venlafaxine|Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
16352158|NCT00248612|Behavioral|CBT|CBT is Cognitive Behavioral Therapy. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
16352159|NCT00248612|Other|Progressive muscle relaxation therapy (PMR)|For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
16352160|NCT00248612|Other|Placebo medication|For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
16352161|NCT00248586|Behavioral|Standard CBT (S-CBT)|Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.
16352162|NCT00248586|Behavioral|Minimal contact CBT (MC-CBT)|Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.
16352163|NCT00248560|Drug|docetaxel|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
16352164|NCT00248560|Drug|Gemcitabine|Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
16352165|NCT00248547|Drug|aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
16352166|NCT00248547|Drug|dexamethasone|For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
16352167|NCT00248547|Drug|ondansetron|For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
16352168|NCT00248547|Drug|placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
16352169|NCT00248534|Biological|rituximab|given IV days 1,8, 15 and 22
16352170|NCT00248534|Drug|methylprednisolone|2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)
16352171|NCT00248534|Drug|temozolomide|Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
16352172|NCT00248521|Drug|alvespimycin hydrochloride|
16352173|NCT00248495|Drug|cisplatin|Given IV
16352174|NCT00248495|Drug|pemetrexed disodium|Given IV
16352175|NCT00248495|Procedure|adjuvant therapy|Metastasis prevention/control
16352176|NCT00248495|Procedure|conventional surgery|Undergoing tissue removal
16352177|NCT00248495|Procedure|neoadjuvant therapy|Tumor Reduction
16352178|NCT00248482|Drug|Cisplatin|Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
16352179|NCT00248482|Drug|Gleevec™|Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
16352180|NCT00248482|Drug|irinotecan|Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
16352181|NCT00248469|Behavioral|In-school Sexual Health Education|
16352182|NCT00248469|Behavioral|Youth-friendly health services|
16352183|NCT00248469|Behavioral|Youth condom promotion & distribution|
16352184|NCT00248469|Behavioral|Community activities related to adolescent sexual health|
16352185|NCT00248456|Drug|Calcipotriol plus betamethasone dipropionate ointment|
16352186|NCT00248443|Procedure|Fiberoptic bronchoscopy and bronchoalveolar lavage|
16352187|NCT00248430|Biological|aldesleukin|
16352188|NCT00248430|Biological|therapeutic allogeneic lymphocytes|
16352189|NCT00248430|Drug|melphalan|
16352190|NCT00248430|Procedure|bone marrow ablation with stem cell support|
16352191|NCT00248430|Procedure|peripheral blood stem cell transplantation|
16352192|NCT00248404|Drug|NB1011|
16352193|NCT00248391|Behavioral|upright feeding|
16352194|NCT00248378|Drug|Smoked Cannabis|
16352195|NCT00248365|Biological|Theralux extracorporeal photochemotherapy|
16352196|NCT00248352|Behavioral|Consultation with Endocrinologist|
16352197|NCT00248352|Behavioral|Counseling from Dietician|
16352198|NCT00248352|Behavioral|Counseling from Diabetes Educator|
16352199|NCT00248339|Drug|Peginterferon-alpha-2b (PEG-Intron)|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
16352804|NCT00243022|Drug|Boswellia serrata extract|given orally
16352200|NCT00248339|Drug|Ribavirin|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
16352201|NCT00248339|Drug|Epoetin-alpha (Procrit)|"PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, ~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
~PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, ~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week."
16352202|NCT00248313|Drug|Rapamune®|
16352203|NCT00248300|Other|Chlorhexidine|Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation
16352204|NCT00248287|Drug|Irinotecan + Carboplatin|irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
16352205|NCT00248287|Drug|irinotecan + Carboplatin + erbitux|irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2
16352206|NCT00248261|Drug|ziprasidone, sertraline|
16352207|NCT00248248|Drug|liposomal doxorubicin|Doxil at 50mg/m2 infused over one hour every 3 or 4 weeks for 3-6 cycles
16352208|NCT00248235|Behavioral|Exercise|
16352209|NCT00248222|Behavioral|Supervised aerobic training|
16352210|NCT00248209|Drug|Wellbutrin XL|Patients randomized to the bupropion treatment group will receive bupropion XL150 mg in the AM for 7 days increasing to 300mg/day (single daily dose). The investigator can increase the dose to 450mg per day at Day 28 if clinically indicated.
16352211|NCT00248196|Device|Reprieve Endovascular Temperature Therapy System|
16352212|NCT00248183|Drug|PRX-00023|
16352213|NCT00248170|Drug|Letrozole|2.5 mg tablets
16352214|NCT00248170|Drug|Anastrozole|1 mg tablets
16352215|NCT00248157|Drug|Octreotide acetate in microspheres|
16352216|NCT00248144|Drug|Famciclovir|
16352217|NCT00248131|Drug|Octreotide acetate in microspheres|
16352218|NCT00248118|Drug|Bupropion|During treatment phase, participants will take 300 mg bupropion or placebo daily.
16352219|NCT00248105|Behavioral|Lifestyle Physical Activity Management|Lifestyle Physical Activity Promotion as given by Physical Activity Advocates. Advocates will meet with participants at baseline and every 3 months throughout the study to promote increase in lifestyle physical activity reached through goal setting and Motivational Interviewing (MI)
16352220|NCT00248092|Drug|NRP104|
16352221|NCT00248079|Device|Coronary Artery Stenting|Initial implant of drug eluting stent (zotarolimus)
16352222|NCT00248066|Drug|RESTEN-MP|
16352223|NCT00248053|Drug|curcumin|curcumin 500 mg by mouth, three times a day for 9 months
16352224|NCT00248040|Drug|Reparixin continuous infusion|The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.
16352225|NCT00248040|Drug|reparixin intermittent infusion|A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline.
16352226|NCT00248040|Other|placebo infusion|placebo was volume/schedule matched saline
16352227|NCT00248014|Device|Mandibular Advancement Via A Functional Appliance|Functional appliance
16352228|NCT00247988|Drug|Weekly Taxotere with weekly carboplatin|
16352229|NCT00247975|Drug|L-carnitine|Patients will be randomized to L-carnitine therapy or placebo. Patients in the treatment group will receive oral L-carnitine (3 grams daily) for 3 days prior to chemotherapy, 1 gram of intravenous L-carnitine (5 cc over 5 minutes, prior to chemotherapy) on the day of chemotherapy and oral L-carnitine (3 grams daily) for 3 days after chemotherapy.
16352230|NCT00247962|Drug|etanercept|50 mg
16352231|NCT00247962|Drug|sulphasalazine (SSZ)|Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
16352232|NCT00247936|Procedure|Laparoscopic Esophagectomy|Laparoscopic Esophagectomy
16352233|NCT00247923|Procedure|Hysteroscopic resection of endometrial polyps. (TCRP)|
16352234|NCT00247910|Drug|Hydrochlorothiazide|Not recorded in detailed description.
16352235|NCT00247897|Drug|Skin antisepsis|See Detailed Description
16352236|NCT00247832|Behavioral|Self-directed motivation|Post-lobectomy patients are provided with a booklet that outlines expected physical activities (sitting up, walking arm exercises) to aim for each day after surgery. It also provides room for the patients to record what they have accomplished.
16352237|NCT00247832|Behavioral|Personal motivational interviewing|Post-lobectomy patients receive daily visits from a study coordinator aimed to motivate the patient to complete various physical activities each day after surgery. The study coordinator goes through the same booklet that is given to Group 2 and helps patients set goals and record their accomplishments.
16352238|NCT00247819|Procedure|Blood draw|
16352239|NCT00247793|Drug|Oral Impact (preoperative enteral nutritional supplement)|
16352240|NCT00247780|Procedure|Pulmonary vein isolation and cavotricuspid ishtmusblock|
16352241|NCT00247754|Behavioral|Cognitive Behaviour Treatment|
16352242|NCT00247741|Drug|spinal administration of articaine|
16352243|NCT00247741|Drug|spinal administration of lidocaine|
16352244|NCT00247728|Drug|PI-88|Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks
16352245|NCT00247715|Drug|algeldrate/magnesium oxide|
16352246|NCT00247715|Drug|ranitidine|
16352247|NCT00247715|Drug|pantoprazole|
16352248|NCT00247702|Drug|warfarin|
16352249|NCT00247676|Drug|Sunitinib (SU011248)|Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
16352250|NCT00247663|Drug|Letrozole|
16352251|NCT00247650|Drug|Zoledronic Acid; Letrozole|
16352252|NCT00247624|Drug|Eszopiclone|Eszopiclone 3 mg every night for 8 weeks
16352253|NCT00247624|Drug|Fluoxetine|Fluoxetine 20 mg every morning for 9 weeks
16352254|NCT00247624|Drug|Placebo|Placebo every night for 8 weeks
16352255|NCT00247611|Behavioral|LifeWindows Intervention Sessions|At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
16352256|NCT00247611|Other|Control|At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
16352257|NCT00247585|Drug|Ethanol (Bourbon or Vodka)|
16352258|NCT00247572|Drug|NRP104|
16352259|NCT00247559|Biological|Botulinum toxin type A|
16352260|NCT00247546|Behavioral|Multifactorial prevention|
16352261|NCT00247533|Procedure|Digital subtraction angiography and 24-hour simultaneous recorder of electrocardiograph|
16352262|NCT00247520|Drug|topical nasal rEV131|
16352263|NCT00247507|Drug|acetylcysteine|
16352264|NCT00247494|Drug|mycophenol mofetil (MMF, Cellcept®) 500 mg BID|
16352265|NCT00247481|Drug|Gefitinib|
16352266|NCT00247481|Drug|Docetaxel|
16352267|NCT00247468|Procedure|Strict Glucose Control|
16352268|NCT00247455|Drug|Low fibre breakfast cereal (puffed rice/cornflakes)|
16352269|NCT00247455|Drug|High fibre cereal (All Bran/Bran Flakes)|
16352270|NCT00247442|Behavioral|Decision aid|
16352271|NCT00247416|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
16352272|NCT00247416|Drug|Dexamethasone|16 mg bid for 4 days prior to each chemotherapy start.
16352273|NCT00247416|Drug|Carboplatin|AUC 6.0 intravenously over 30 minutes on day 5.
16352274|NCT00247403|Drug|2-deoxyglucose (2DG)|Addition of 2DG to stereotactic radiosurgery. Dose escalation study.
16352275|NCT00247390|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.
16352276|NCT00247390|Drug|Placebo|Ramelteon placebo-matching tablets, orally, once daily for up to 42 weeks.
16352277|NCT00247377|Procedure|Gastric bypass surgery|in order to meet health requirements for patient, gastric bypass surgery was undergone
16352278|NCT00247377|Procedure|Lap-Band|in order to meet health requirements for patient, gastric band surgery was undergone
16352279|NCT00247364|Drug|Levetiracetam (Keppra)|
16352280|NCT00247351|Procedure|Cryoablation|
16352281|NCT00247338|Drug|low calorie, low nitrogen parenteral nutrition for patient with NRS score 3|
16352282|NCT00247325|Drug|Iodixanol(Drug)|
16352283|NCT00247312|Radiation|Pd-103|
16352284|NCT00247299|Device|IPL Quantum Product manufactured by Luminis Ltd.|
16352285|NCT00247286|Behavioral|weighted vaginal cones|
16352286|NCT00247286|Behavioral|Biofeedback|Pelvic floor muscles exercises performed with a biofeedback machine
16352287|NCT00247273|Drug|risedronate|tablet, 5 mg risedronate, once a day for 2 years
16352288|NCT00247273|Drug|risedronate|oral, 150 mg risedronate, once a month for 2 years
16352289|NCT00247260|Device|32P BioSilicon|
16352290|NCT00247247|Drug|Comtess®|
16352291|NCT00247234|Behavioral|Schema Therapy|group based schema therapy
16352292|NCT00247234|Behavioral|standard care|standard psychiatric out-patient care
16352293|NCT00247221|Behavioral|MI/Family Check-up|The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention.
16352294|NCT00247221|Behavioral|MI only|An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
16352295|NCT00247208|Device|Taxus polymer-based paclitaxel-eluting stent|Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
16352296|NCT00247208|Device|Express 2 bare metal stent|Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
16352297|NCT00247195|Behavioral|Culturally Congruent Assessment and Treatment|Referral, engagement, and treatment is done following the cultural formulation model in DSM-IV in which patients' views and expectations about depression treatment are included in the assessment and treatment process.
16352298|NCT00247182|Behavioral|Step 1: Minimal Intervention|All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later. All students will complete 3, 6, and 9 month follow-up assessments
16352299|NCT00247182|Behavioral|Step 2: Brief Motivational Intervention|Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
16352300|NCT00247182|Behavioral|Alcohol Assessment|Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
16352301|NCT00247169|Drug|progesterone|Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
16352302|NCT00247156|Procedure|Acupressure treatments and NAET treatments|
16352303|NCT00247143|Drug|Kaletra (drug)|
16352304|NCT00247130|Drug|Omeprazole|
16352305|NCT00247130|Drug|Ranitidine|
16352306|NCT00247117|Drug|Metformin|
16352307|NCT00247104|Drug|Cranberries - Vaccinium macrocarpon|
16352308|NCT00247091|Biological|standard-titer measles vaccine|
16352309|NCT00247078|Biological|widow spider antivenom|3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
16352310|NCT00247078|Biological|Placebo|
16352311|NCT00247052|Drug|diclofenac|diclofenac 50 mg bid versus placebo bid
16352312|NCT00247052|Drug|diclofenac|diclofenac 100 mg per day for 14 days
16352313|NCT00247052|Drug|matching placebo|
16352314|NCT00247039|Dietary Supplement|Solgar Israel|Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
16359260|NCT00186537|Behavioral|Weight Loss|
16352318|NCT00247000|Device|Routine Care in a HF clinic vs Home Telehealth Care for HF|
16352319|NCT00246987|Drug|Muraglitazar|
16352320|NCT00246974|Drug|Gemcitabine|intravenous
16352321|NCT00246974|Drug|Cisplatin|intravenous
16352322|NCT00246974|Drug|Gefitinib|oral
16352323|NCT00246948|Procedure|Active conservative treatment of sciatica|
16352324|NCT00246935|Drug|Roflumilast|
16352325|NCT00246922|Drug|Roflumilast|
16352326|NCT00246909|Drug|Pantoprazole|
16352327|NCT00246896|Behavioral|care management|
16352328|NCT00246883|Procedure|Exercise|
16352329|NCT00246818|Procedure|Tai Chi Chuan|
16352330|NCT00246805|Device|Vitatron pacemaker C20 SSIR or T20 SSIR models|VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
16352331|NCT00246792|Behavioral|Group treatment|
16352332|NCT00246779|Procedure|Modified ultrafiltration|
16352333|NCT00246753|Drug|lapatinib ditosylate|1500 mg, daily until disease progression
16352334|NCT00246740|Drug|Periostat|In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
16352335|NCT00246740|Drug|Placebo Oral Tablet|In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
16352336|NCT00246727|Drug|Selected Vegetable and Herb Mix|The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.
16352337|NCT00246714|Drug|repeated injections of endotoxin during 5 days|
16352338|NCT00246701|Drug|Simvastatin|Simvastatin
16352339|NCT00246701|Drug|Simvastatin + Lovaza|Simvastatin + Lovaza (omega-3-acid ethyl esters)
16352340|NCT00246688|Drug|Sagopilone (BAY86-5302 , ZK219477)|10.5 mg lyophilized sagopilone per vial
16352341|NCT00246675|Drug|Frusemide|
16352342|NCT00246662|Drug|Vosaroxin|All patients receive vosaroxin Injection
16352343|NCT00246636|Drug|Antara (fenofibrate) + Lovaza|Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
16352344|NCT00246636|Drug|Antara (fenofibrate)|Antara (fenofibrate) + placebo
16352345|NCT00246623|Drug|Exubera (inhaled insulin)|
16352346|NCT00246623|Procedure|8-point glucose diary (to assess pre- and post prandial glucoses)|
16352347|NCT00246623|Procedure|Meal Tolerance Test|
16352348|NCT00246623|Procedure|24-hour continuous glucose monitoring (at select sites)|
16352349|NCT00246623|Procedure|Pulmonary Function Testing|
16352350|NCT00246623|Procedure|Hypoglycemic Event Monitoring|
16352351|NCT00246623|Procedure|Laboratory Assessments|
16352352|NCT00246623|Behavioral|Nutritional Counseling and Diabetes Education|
16352353|NCT00246610|Drug|Nelfinavir mesylate, 625 mg|Nelfinavir 625 mg [dosed orally as 1250 mg BID (two 625 mg tablets given orally BID)] plus Combivir (lamivudine 150 mg plus zidovudine 300 mg BID dosed orally) administered with food. Subjects will start treatment at their baseline visit. Subjects will be treated for up to 26 weeks during pregnancy plus 6 weeks postpartum.
16352354|NCT00246597|Drug|epoetin alfa|
16352355|NCT00246584|Drug|SPP100|
16352356|NCT00246571|Drug|SU011248|SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
16352357|NCT00246571|Drug|Chemotherapy|"The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.
~Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
~Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
~Docetaxel - 75-100 mg/m2 every 3 weeks
~Paclitaxel - 175-200 mg/m2 every 3 weeks
~Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
~Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248."
16352358|NCT00246545|Behavioral|exercise|
16352359|NCT00246532|Drug|Morphine|Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
16352360|NCT00246532|Drug|Placebo|Patients will receive placebo tablets.
16352361|NCT00246519|Drug|Hydrochlorothiazide|atenolol 50 or 100 mg hydrochlorothiazide 12.5 or 25 mg
16352362|NCT00246519|Drug|Atenolol|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
16352363|NCT00246506|Procedure|intrauterine insemination|An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.
16352364|NCT00246506|Procedure|in vitro fertilization|This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.
16352365|NCT00246467|Biological|Alhydrogel|
16352366|NCT00246467|Biological|rF1 and rV protein antigens|
16352367|NCT00246441|Drug|Paroxetine|16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day
16352805|NCT00243022|Dietary Supplement|cyanocobalamin|given orally
16352368|NCT00246441|Drug|Placebo|treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
16352369|NCT00246428|Behavioral|Motivational Interviewing|Experimental manipulations will be evaluated 6, 9, and 12 months
16352370|NCT00246415|Drug|Memantine|
16352371|NCT00246402|Drug|Acipimox|
16352372|NCT00246389|Drug|cyclobenzaprine hydrochloride|
16352373|NCT00246376|Behavioral|Diet|ATP-III diet
16352374|NCT00246376|Behavioral|Exercise|Supervised exercise in study gym
16352375|NCT00246376|Drug|Niacin|Niaspan, titrated up to 2 grams per day
16352376|NCT00246376|Drug|Fenofibrate|Tricor, 120 mg per day
16352377|NCT00246376|Other|Placebos|Placebos for Niaspan and Tricor
16352378|NCT00246363|Drug|Silymarin|Silymarin (milk thistle)
16352379|NCT00246363|Drug|Placebo|Placebo
16352380|NCT00246350|Procedure|massage|8 light massage treatments and hot pack
16352381|NCT00246350|Procedure|massage|16 light massage treatments and hot packs
16352382|NCT00246350|Procedure|spinal manipulation|8 high velocity, low amplitude spinal manipulation treatments and hot pack
16352383|NCT00246350|Procedure|Spinal manipulation|16 high velocity, low amplitude spinal manipulation treatments and hot pack
16352384|NCT00246337|Drug|Comparator: Placebo|Placebo to match assigned treatment arm; one orally-administered dose
16352385|NCT00246337|Drug|MK0974|MK0974 25 mg; one orally-administered dose
16352386|NCT00246337|Drug|MK0974|MK0974 50 mg; one orally-administered dose
16352387|NCT00246337|Drug|MK0974|MK0974 100 mg; one orally-administered dose
16352388|NCT00246337|Drug|MK0974|MK0974 200 mg; one orally-administered dose
16352389|NCT00246337|Drug|MK0974|MK0974 300 mg; one orally-administered dose
16352390|NCT00246337|Drug|MK0974|MK0974 400 mg; one orally-administered dose
16352391|NCT00246337|Drug|MK0974|MK0974 600 mg; one orally-administered dose
16352392|NCT00246337|Drug|Rizatriptan|Rizatriptan 10 mg; one orally-administered dose
16352393|NCT00246324|Drug|Interferon beta 1a, oral doxycycline|Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
16352394|NCT00246298|Drug|epoetin alfa|
16352395|NCT00246285|Drug|risperidone|
16352396|NCT00246272|Drug|risperidone|
16352397|NCT00246259|Drug|Risperidone long-acting injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.
16352398|NCT00246259|Drug|Oral Antipsychotic|Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.
16352399|NCT00246246|Drug|risperidone|
16352400|NCT00246233|Drug|methylphenidate|
16352401|NCT00246220|Drug|methylphenidate hydrochloride|
16352402|NCT00246207|Drug|CONCERTA (OROS methylphenidate hydrochloride)|
16352403|NCT00246194|Drug|risperidone (RISPERDAL CONSTA)|Long-acting injectable of risperidone given as per the prescription from the prescribing physician.
16352404|NCT00246181|Procedure|radiation therapy|Patients will receive 3 fractions
16352405|NCT00246168|Drug|tramadol hydrochloride + acetaminophen|
16352406|NCT00246155|Biological|Botulinum toxin type A|
16352407|NCT00246142|Biological|Botulinum toxin type A|
16352408|NCT00246129|Drug|Campath|Monoclonal antibody induction therapy
16352409|NCT00246129|Drug|Daclizumab|Monoclonal antibody induction therapy
16352410|NCT00246116|Procedure|Functional Imaging of Treatment Effects|PET & VQ Scans
16352411|NCT00246103|Drug|Valproic acid|Beginning Dose, Level 1: 15 mg/kg/day.
16352412|NCT00246103|Drug|Epirubicin|Beginning Dose, Level 1: 75 mg/m^2.
16352413|NCT00246103|Drug|5-fluorouracil|For breast cancer participants treated at MTD of Valproic acid and Epirubicin: 5-fluorouracil 500 mg/m^2.
16352414|NCT00246103|Drug|Cyclophosphamide.|For breast cancer participants treated at MTD of Valproic acid and Epirubicin: cyclophosphamide 500 mg/m^2.
16352415|NCT00246090|Drug|E7389|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
16352416|NCT00246064|Drug|infliximab|
16352417|NCT00246051|Behavioral|Sleep Hygiene Education|An education program, consisting of materials from experts in the field of fatigue management, will be provided to all police officers in the intervention group. Videotapes, slides, handouts and other educational material will be compiled to create a variety of information sources for police officers. Examples of materials to be incorporated into this training program would be the Operation Healthy Sleep Training Video, powerpoint created by the Harvard Work Hours, Health and Safety Group and pamphlets provided by the American Academy of Sleep Medicine.
16352418|NCT00246051|Other|Expert-Led Sleep Disorders Screening and Treatment|"Expert-led sleep disorder screening and treatment will consist of visiting police stations and presenting an information session about Operation Healthy Sleep. The session will take place during work time. During the session, we will invite officers to take the Operation Healthy Sleep survey. All subjects that answer the survey indicating that they are at high risk on the Berlin Questionnaire will be contacted to arrange an initial appointment at our OSA research clinic. If they don't meet the criteria they will be disempanelled.
~Positive on the Berlin Questionnaire
~Clinic visit, exam with a physician, given a home diagnostic device (HDD)
~High risk on HDD, seen by physician, given a CPAP machine
~Follow up visit after 2-3 weeks, CPAP data downloaded and reviewed
~Contacted by a sleep health clinic at 3, 6, 12 months
~After 12 months subject will be referred to their primary care physician"
16352419|NCT00246051|Other|Online Sleep Disorders Screening|Online sleep disorder screening will be available to all police officers nation-wide through the Operation Healthy Sleep survey. All subjects that answer the survey questions indicating that they are at high risk of a sleep disorder will be notified either online following the completion of the survey or by email or a letter. Treatment and follow up will not be conducted for individuals who screen positive on the online version of the Operation Healthy Sleep survey.
16352420|NCT00246038|Device|Boston Scientific ENOVUS AAA Endograft|
16352421|NCT00246025|Drug|Dabigatran etexilate|Dabigatran etexilate 110 mg capsule, once a day, oral administration
16352422|NCT00246025|Drug|Dabigatran etexilate|Dabigatran etexilate 150 mg capsule, once a day, oral administration
16352423|NCT00246025|Drug|Dabigatran Etexilate|Dabigatran etexilate 220 mg capsule, once a day, oral administration
16352424|NCT00246025|Drug|placebo|matching placebo capsule, once a day, oral administration
16352425|NCT00246012|Drug|Intetumumab|Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). In Phase 2, intetumumab (5 mg/kg or 10 mg/kg) will be administered for 8 cycles until no evidence of disease progression or unacceptable toxicity. If a participant responds to therapy with stable disease (SD) or better, the participant will be eligible to receive up to 8 cycles of extended administrations.
16352426|NCT00246012|Drug|Dacarbazine|Commercially available dacarbazine will be administered intravenously over a 60-minute period (+30 minutes/-30 minutes) and prior to the intetumumab/placebo infusion. In case participants are unable to tolerate dacarbazine even after 2 dose reductions, they will be given the option to continue on intetumumab alone.
16352427|NCT00246012|Drug|Placebo|Placebo will be administered intravenously over a period of 2 hours (+15 minutes/-15 minutes).
16352428|NCT00245986|Procedure|Blood draw|
16352429|NCT00245973|Drug|Bifeprunox|
16352430|NCT00245960|Drug|etanercept|Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
16352431|NCT00245947|Drug|ERB-041|
16352432|NCT00245934|Drug|Enbrel|
16352433|NCT00245921|Drug|Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg|
16352434|NCT00245908|Drug|azithromycin|
16352435|NCT00245895|Drug|Aranesp|Aranesp
16352436|NCT00245882|Behavioral|Care Coordination|Care coordination with monthly follow-up by a diabetes nurse educator
16352437|NCT00245882|Behavioral|Home Telemedicine|Active care management by a nurse practitioner using home telemedicine
16352438|NCT00245869|Procedure|Contrast-enhanced Ultrasound|
16352439|NCT00245856|Drug|Dalteparin sodium injection|200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.
16352440|NCT00245856|Drug|Warfarin|Titrated to INR 2-3 through study month 3
16352441|NCT00245843|Behavioral|Mother Infant Transaction Program (MITP)|Psychosocial intervention. 11-session one hour standardized intervention program. The aim of the MITP is to help parents to appreciate their infant's unique characteristics,temperament and developmental potential.
16352442|NCT00245830|Procedure|Ischemic Preconditioning|Experimental: Hepatic Ischemic Preconditioning blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.
16352443|NCT00245817|Behavioral|HINCAB|Psycho-educative intervention performed 2 and 4 weeks after surgery
16352444|NCT00245791|Drug|Levofloxacin|
16352445|NCT00245765|Drug|Certolizumab Pegol|"Pharmaceutical Form: solution for injection in pre-filled syringe
~Route of Administration: subcutaneous use"
16352446|NCT00245765|Other|Placebo|Matching Placebo to Certolizumab Pegol
16352447|NCT00245752|Device|acupuncture|acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
16352448|NCT00245739|Drug|TMC-114|600/100 mg tablets of TMC114/rtv BID until commercial available to the subject
16352449|NCT00245726|Device|FES Cycle|Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week
16352450|NCT00245726|Device|ES therapy|Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week
16352451|NCT00245726|Device|Passive (Motor Assist) Cycle|Subjects will use a cycle that moves the legs for 1 hour/3x per week
16352452|NCT00245713|Drug|levetiracetam|
16352453|NCT00245687|Device|Tiger Tube|
16352454|NCT00245674|Drug|amisulpride|
16352455|NCT00245661|Drug|Temazepam|
16352456|NCT00245648|Drug|fibrinolytic therapy or combination reduced fibrinolytic therapy|
16352457|NCT00245635|Drug|Fluoxetine|Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
16352458|NCT00245635|Drug|Placebo|Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.
16352459|NCT00245622|Biological|Tovaxin Autologous T cell vaccine|subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
16352460|NCT00245622|Biological|Placebo|subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
16352461|NCT00245609|Drug|Pregabalin|
16352462|NCT00245609|Drug|Alprazolam|
16352463|NCT00245609|Drug|Placebo|
16352464|NCT00245596|Drug|sildenafil|
16352465|NCT00245583|Drug|Topiramate|minimum does of 50mg/day
16352466|NCT00245583|Drug|Placebo|matching tablet
16352467|NCT00245570|Drug|Comparator: Montelukast|1 dose montelukast 10 mg tablet given orally in one of three treatment periods
16352468|NCT00245570|Drug|Comparator: Salmeterol|1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
16352469|NCT00245570|Drug|Comparator: Placebo (montelukast)|1 dose matching-image placebo to montelukast tablet in two of three treatment periods
16352470|NCT00245570|Drug|Comparator: Placebo (salmeterol)|1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
16352471|NCT00245557|Drug|Sertraline|"Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.
~Duration of treatment was 12 weeks."
16352472|NCT00245544|Drug|MK0759|
16352473|NCT00245518|Drug|Isoflavone|
16352474|NCT00245518|Drug|Placebos|
16352475|NCT00245505|Drug|Mesalazine (Mesalamine)|Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment
16352476|NCT00245492|Procedure|Chromocolonoscopy|Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
16352477|NCT00245479|Drug|Primary nocturnal enuresis|Desmopressin
16352478|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
16352479|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
16352480|NCT00245466|Drug|Degarelix|Given as a subcutaneous injection once every 4 weeks.
16352806|NCT00243009|Drug|cyclosporine|
16352481|NCT00245453|Drug|azithromycin|250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
16352482|NCT00245453|Drug|telithromycin|400 mg tablets; 2 tablets once daily (QD) for 5 days
16352483|NCT00245453|Drug|Clarythromycin|500 mg extended release tablets; 2 tablets QD for 7 days
16352484|NCT00245440|Drug|Azithromycin|250 mg tablets; 2 tablets once daily (500 mg) for 3 days
16352485|NCT00245440|Drug|Telithromycin|400 mg tablets; 2 tablets once daily (800 mg) for 5 days
16352486|NCT00245427|Drug|all macrolide antibiotics|Varies based on antibiotic
16352487|NCT00245427|Drug|all beta-lactam antibiotics|Varies based on antibiotic
16352488|NCT00245414|Drug|Pegasys®|180μg for s.c./week for 48 weeks
16352489|NCT00245414|Drug|Pegasys®|180μg for s.c./week for 24 weeks
16352490|NCT00245401|Device|CYPHERTM Sirolimus-Eluting Coronary Stent|
16352491|NCT00245388|Drug|Muraglitazar|
16352492|NCT00245375|Drug|Tylenol #3|
16352493|NCT00245375|Drug|Combination Tylenol and Ibuprofen|
16352494|NCT00245362|Biological|CG 8020 and CG 2505|
16352495|NCT00245349|Procedure|F-18 Fluorothymidine|
16352496|NCT00245336|Biological|rThrombin|1000 U/mL applied topically in combination with absorbable gelatin sponge
16352497|NCT00245336|Drug|bovine thrombin|1000 U/mL applied topically in combination with absorbable gelatin sponge
16352498|NCT00245323|Behavioral|Smoking status as a routine vital sign|
16352499|NCT00245310|Procedure|Indocyangreen (ICG) clearance|
16352500|NCT00245297|Drug|Kogenate FS, reconstituted in a suspension of liposomes|
16352501|NCT00245271|Drug|OMS103HP|Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours
16352502|NCT00245271|Drug|Vehicle|Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.
16352503|NCT00245258|Drug|Sildenafil Citrate|
16352504|NCT00245245|Drug|recombinant porcine coagulation factor VIII (OBI-1)|
16352505|NCT00245232|Behavioral|Cognitive Therapy|
16352506|NCT00245232|Behavioral|Cognitive Processing Therapy|
16352507|NCT00245232|Behavioral|Written Exposure|
16352508|NCT00245219|Behavioral|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
16352509|NCT00245219|Behavioral|Peer support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
16352510|NCT00245206|Drug|Aripiprazole|Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
16352511|NCT00245206|Drug|Olanzapine|Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
16352512|NCT00245206|Drug|Risperidone|Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
16352513|NCT00245193|Behavioral|Motivationally-Enhanced Interpersonal Psychotherapy|
16352514|NCT00245180|Behavioral|Diet|
16352515|NCT00245180|Behavioral|Exercise|
16352516|NCT00245167|Procedure|Tracheal Aspirate Fluid|
16352517|NCT00245154|Drug|carboplatin|Given IV
16352518|NCT00245154|Drug|cediranib maleate|Given orally
16352519|NCT00245154|Drug|paclitaxel|Given IV
16352520|NCT00245154|Other|placebo|Given orally
16352521|NCT00245141|Biological|dactinomycin|
16352522|NCT00245141|Drug|cyclophosphamide|
16352523|NCT00245141|Drug|vincristine sulfate|
16352524|NCT00245141|Radiation|radiation therapy|
16352525|NCT00245128|Drug|imatinib mesylate|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
16352526|NCT00245115|Biological|filgrastim|
16352527|NCT00245115|Drug|busulfan|
16352528|NCT00245115|Drug|cyclophosphamide|
16352529|NCT00245115|Procedure|in vitro-treated bone marrow transplantation|
16352530|NCT00245115|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16352531|NCT00245102|Drug|sorafenib tosylate|Given orally
16352532|NCT00245089|Biological|dactinomycin|
16352533|NCT00245089|Drug|cyclophosphamide|
16352534|NCT00245089|Drug|vincristine sulfate|
16352535|NCT00245076|Behavioral|smoking cessation intervention|
16352536|NCT00245076|Other|internet-based intervention|
16352537|NCT00245063|Drug|cediranib maleate|Given PO
16352538|NCT00245063|Other|laboratory biomarker analysis|Correlative studies
16352539|NCT00245063|Other|pharmacogenomic studies|Optional correlative studies
16352540|NCT00245050|Dietary Supplement|pyridoxine hydrochloride|Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.
16352541|NCT00245050|Drug|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
16352542|NCT00245050|Drug|doxorubicin HCL liposome|IV, 40mg/m2
16352543|NCT00245037|Biological|therapeutic allogeneic lymphocytes|A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
16352544|NCT00245037|Drug|busulfan|"Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
~IV busulfan is available and diluted and administered per package insert guidelines."
16352807|NCT00243009|Drug|fludarabine phosphate|
16360637|NCT00173628|Procedure|blood drawing|
16352545|NCT00245037|Drug|cyclosporine|"Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including Interleukin 2 (IL-2) and Interleukin 4 (IL-4).
~- Starting on day -3, Cyclosporine (CSP) is given at a dose of 4.0 mg/kg p.o. b.i.d."
16352546|NCT00245037|Drug|fludarabine phosphate|"Fludarabine's active metabolite 2-fluoro-ara-A is an antimetabolite that inhibits DNA primase, DNA polymerase alpha and ribonucleotide nuclease.
~Dosing: Days -4, -3 and -2: Fludarabine 30 mg/m2/day IV. Total dose equals 90 mg/m2.
~Monitoring: Fludarabine level is not monitored.
~Dose Adjustments: There are no provisions for fludarabine dose adjustments."
16352547|NCT00245037|Drug|mycophenolate mofetil|"Mycophenolate mofetil (MMF) is the morpholinyl ethyl ester of mycophenolic acid (MPA) and reversibly inhibits inosine monophosphate dehydrogenase, particularly the type II isoform that is more prominent in activated lymphocytes. As a result of the inhibition of de novo purine synthesis, proliferation of B- and T-lymphocytes is blocked and antibody production is inhibited.
~Related Donors: MMF will be given daily at 15mg/kg q 12 hrs until day +28, then stop without tapering. Doses will be rounded to the nearest 250 mg (capsules are 250 mg).
~Unrelated Donors: MMF will be given daily at 15mg/kg q 8 hrs until day +28, then given daily at 15mg/kg q 12 hours until day +56, then stop without tapering. Doses will be rounded to the nearest 250 mg (capsules are 250 mg)."
16352548|NCT00245037|Procedure|peripheral blood stem cell transplantation|"Bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) are procedures that restore stem cells that have been destroyed by high doses of chemotherapy and/or radiation therapy. There are three types of transplants:
~In autologous transplants, patients receive their own stem cells.
~In syngeneic transplants, patients receive stem cells from their identical twin.
~In allogeneic transplants, patients receive stem cells from their brother, sister, or parent. A person who is not related to the patient (an unrelated donor) also may be used."
16352549|NCT00245037|Radiation|Total Body Irradiation (TBI)|"TBI is a form of radiotherapy used primarily as part of the preparative regimen for haematopoietic stem cell (or bone marrow) transplantation. As the name implies, TBI involves irradiation of the entire body, though in modern practice the lungs are often partially shielded to lower the risk of radiation-induced lung injury.
~Toxicities: At the dosage used, side effects are not expected. Nevertheless, there may be fever, alopecia, parotitis, diarrhea, reversible skin pigmentation, mucositis and late effects including cataract formation, pulmonary damage, carcinogenesis, and sterilization.
~Dosing: TBI will be given in one 200 cGy fraction from linear accelerator at a rate of 15-19 cGy/min."
16352550|NCT00245037|Drug|Granulocyte colony-stimulating factor (G-CSF)|"Granulocyte colony-stimulating factor (G-CSF or GCSF) is a colony-stimulating factor hormone. G-CSF is also known as colony-stimulating factor 3 (CSF 3).
~It is a glycoprotein, growth factor and cytokine produced by a number of different tissues to stimulate the bone marrow to produce granulocytes and stem cells. G-CSF then stimulates the bone marrow to release them into the blood.
~Toxicities: At the dosage used, the most common side effect will be medullary bone pain.
~Dosing: 5 mcg/kg/day given per institutional standards (on approximately days 10-15 or not at all)."
16352551|NCT00245037|Drug|Phenytoin|This drug is used to prevent seizures while on chemotherapy.
16352552|NCT00245037|Drug|Methotrexate|Methotrexate is used to treat severe psoriasis (a skin disease in which red, scaly patches form on some areas of the body) that cannot be controlled by other treatments.
16352553|NCT00245024|Drug|sulindac|
16352554|NCT00245024|Other|laboratory biomarker analysis|
16352555|NCT00245011|Biological|filgrastim|Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.
16352556|NCT00245011|Drug|ifosfamide|Ifosfamide administered IV.
16352557|NCT00245011|Procedure|peripheral blood stem cell transplantation|Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
16352558|NCT00245011|Radiation|Sm-EDTMP (low dose)|Sm-EDTMP (low dose) administered after autologous stem cell collection
16352559|NCT00245011|Radiation|sm-EDTMP (higher dose)|Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
16352560|NCT00244998|Drug|fulvestrant|IM
16352561|NCT00244985|Biological|rituximab|IV
16352562|NCT00244985|Drug|pegylated liposomal doxorubicin hydrochloride|IV
16352563|NCT00244972|Other|Laboratory Biomarker Analysis|Correlative studies
16352564|NCT00244972|Drug|Sorafenib Tosylate|Given PO
16352565|NCT00244972|Drug|Tipifarnib|Given PO
16352566|NCT00244959|Drug|anastrozole|1 mg orally daily for 12 months
16352567|NCT00244959|Procedure|adjuvant therapy|treatment received after breast cancer surgery
16352568|NCT00244946|Biological|therapeutic autologous lymphocytes|Lymphocytes collected by standard apheresis technique either prior to or post stem cell mobilization and collection
16352569|NCT00244946|Drug|carmustine|
16352570|NCT00244946|Drug|cytarabine|
16352571|NCT00244946|Drug|etoposide|
16352572|NCT00244946|Drug|melphalan|
16352573|NCT00244946|Procedure|peripheral blood stem cell transplantation (PBSCT)|
16352574|NCT00244933|Dietary Supplement|genistein|Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
16352575|NCT00244933|Drug|gemcitabine|Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
16352576|NCT00244933|Procedure|Tumor biopsy|Biopsy of tumor prior to dose of genistein (Novasoy)
16352577|NCT00244920|Drug|bicalutamide|
16352578|NCT00244920|Drug|leuprolide acetate|
16352579|NCT00244920|Drug|squalamine lactate|
16352580|NCT00244920|Procedure|adjuvant therapy|
16352581|NCT00244920|Procedure|antiandrogen therapy|
16352582|NCT00244920|Procedure|antiangiogenesis therapy|
16352583|NCT00244920|Procedure|conventional surgery|
16352584|NCT00244920|Procedure|neoadjuvant therapy|
16352585|NCT00244920|Procedure|releasing hormone agonist therapy|
16352586|NCT00244907|Dietary Supplement|Genistein vs Risedronate|Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
16352697|NCT00244023|Drug|testosterone|testosterone gel, one sachet of 50 mg applied once a day, possibly titrated to 100 mg if insufficient effect
16352698|NCT00244023|Other|placebo gel|one sachet of placebo gel once a day possibly titrated to 2 sachets if insufficient efficacy
16352587|NCT00244894|Procedure|acupuncture therapy|Acupuncture treatments will be administered by a qualified practitioner twice a week for the first four weeks and once per week for an additional 6 weeks. Sterile, disposable Seirin needles will be placed bilaterally at the point Gallbladder 34, and along the spine at Bladder 15, Bladder 23, and Bladder 32. Low intensity electrostimulation at 2 Hz will be used for both Bladder 23 and Bladder 32. Points will also be placed unilaterally at Governing vessel 20, Heart 7, Pericardium 6, Liver 2, and Spleen 6
16352588|NCT00244894|Procedure|fatigue assessment and management|Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.
16352589|NCT00244894|Procedure|hot flashes attenuation|Patients will be asked to report hot flash frequency and severity daily using the hot flash diary (HFD) and hot flash severity guidelines (HFSG) throughout the treatment period.
16352590|NCT00244894|Procedure|management of therapy complications|Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
16352591|NCT00244894|Procedure|quality-of-life assessment|Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.
16352592|NCT00244881|Drug|cediranib maleate|Given orally
16352593|NCT00244881|Other|laboratory biomarker analysis|Correlative studies
16352594|NCT00244868|Other|counseling intervention|
16352595|NCT00244868|Other|educational intervention|
16352596|NCT00244855|Other|pharmacological study|Correlative studies
16352597|NCT00244855|Biological|rituximab|Given IV
16352598|NCT00244855|Drug|dexamethasone|Given IV
16352599|NCT00244855|Other|laboratory biomarker analysis|Correlative studies
16352600|NCT00244842|Drug|voclosporin|voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
16352601|NCT00244842|Drug|Placebo|Placebo
16352602|NCT00244829|Drug|imatinib mesylate|
16352603|NCT00244829|Procedure|adjuvant therapy|
16352604|NCT00244816|Drug|Taxoprexin|
16352605|NCT00244790|Behavioral|Diet|crossover low vs high protein diet before and after weight loss
16352606|NCT00244777|Drug|Hypo-osmolar ORS|
16352607|NCT00244764|Drug|GW786034|All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
16352608|NCT00244764|Drug|Placebo|All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
16352609|NCT00244751|Drug|GI262570 0.5 mg|GI262570 0.5 mg
16352610|NCT00244751|Drug|GI262570 1.0 mg|GI262570 1.0 mg
16352611|NCT00244751|Drug|Placebo|Placebo
16352612|NCT00244738|Dietary Supplement|Castor oil|Patients who received castor oil for labor induction
16352613|NCT00244738|Dietary Supplement|Sunflower oil|Patients who received sunflower oil as a placebo
16352614|NCT00244725|Drug|Odiparcil|
16352615|NCT00244725|Drug|Warfarin|
16352616|NCT00244725|Drug|Coumadin|
16352617|NCT00244712|Drug|emtricitabine/tenofovir|The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
16352618|NCT00244712|Drug|abacavir/lamivudine|The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
16352619|NCT00244699|Behavioral|MI Alone or Plus Mindfulness-Based Skills Training|
16352620|NCT00244686|Drug|Mepolizumab|open label investigational product
16352621|NCT00244673|Biological|DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4|Trial of not providing 3. and/or 4. DTP together with or after MV at 9 to 18 month of age.
16352622|NCT00244660|Procedure|Frequent blood pressure measurements|
16352623|NCT00244660|Behavioral|Education|
16352624|NCT00244647|Drug|RESTEN-MP|
16352625|NCT00244634|Drug|candsartan cilexetil|
16352626|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.05 mg/kg once daily oral liquid dose
16352627|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.20 mg/kg once daily oral liquid dose
16352628|NCT00244621|Drug|candesartan cilexetil (Atacand)|0.40 mg/kg once daily oral liquid dose
16352629|NCT00244608|Drug|Budesonide/Formoterol Turbuhaler|
16352630|NCT00244608|Drug|Budesonide Turbuhaler (Pulmicort)|
16352631|NCT00244608|Drug|Terbutaline Turbuhaler|
16352632|NCT00244595|Drug|candsartan cilexetil|
16352633|NCT00244569|Drug|13C-Methacetin|
16352634|NCT00244569|Device|Breath ID Machine|
16352635|NCT00244556|Drug|Methotrexate plus ENBREL or ENBREL alone|
16352636|NCT00244543|Drug|R89674 (generic name not yet established)|
16352637|NCT00244530|Drug|Nifedipine|
16352638|NCT00244517|Drug|TTE measurements under anesthesia with sevoflurane, isoflurane, desflurane, and remifentanyl|TTE measurements were performed during remifentanil 2 ng/ml TCI end-organ concentration, 1 MAC of either anesthetic gas under spontaneous ventilation and 1 MAC of either anesthetic under IPPV
16352639|NCT00244517|Drug|Sevoflurane, Isoflurane, Desflurane|1 MAC
16352640|NCT00244504|Drug|moxonidine|moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
16352641|NCT00244491|Behavioral|Care Transitions Intervention|
16352642|NCT00244478|Dietary Supplement|Soy Protein Dietary Supplement|The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving.
16352643|NCT00244478|Dietary Supplement|Placebo|The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.
16352644|NCT00244452|Drug|Cetrorelix|
16352645|NCT00244439|Drug|MALG|30 minute application
16352646|NCT00244439|Drug|Ovide (malathion) lotion 0.05%|8-12 hour application
16352647|NCT00244439|Drug|Permethrin 1%|10 minute application
16352648|NCT00244426|Drug|indobufen|Indobufen capsules 100 and 200mg
16352649|NCT00244426|Drug|aspirin|Acetylsalicylic acid capsules 300mg
16352650|NCT00244387|Drug|SPM 962|
16360708|NCT00171847|Drug|Letrozole|
16352651|NCT00244374|Biological|Hepatitis A & B vaccine|Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
16352652|NCT00244374|Behavioral|Outreach|Outreach worker vaccine adherence support: Half of cohort subjects will be assigned to outreach worker vaccine adherence support and will meet with their outreach workers from Haight Ashbury Youth Outreach Team (HAYOT) and Glide Health Services on the day of vaccine cohort study enrollment. Intensive vaccination tracking and in-person outreach support will begin one week before the second and third vaccine doses are due, and again two weeks before the fourth dose is due.
16352653|NCT00244374|Behavioral|AIC|The Adult Immunization Clinic (AIC) is a public low-cost vaccine clinic located centrally at 101 Grove Street in the lobby of the San Francisco Department of Public Health (SFDPH). The clinic is open from Monday-Friday 9 a.m. to 4 p.m. Nurses at the AIC will be available 40 hours/week to administer free immunizations to study subjects.
16352654|NCT00244374|Behavioral|SEP|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Research nurses will provide 16 hours/week of vaccine administration services at SEPs well attended by young IDU. The San Francisco Needle Exchange (SFNE) serves primarily youth and young adults on Mondays, Wednesdays, and Fridays from 5-7 p.m. in an indoor location in the Haight-Ashbury district. A study nurse will be at SFNE for a total of 6 hours per week. HIV Prevention Project (HPP) sites also operate for 2 hrs each (Tues, Thu, Fri, Sat). Medical services are provided either in a clinic setting at indoor sites (6th Street) or at outdoor sites (Hemlock Alley, Duboce). A study nurse will attend each of these 5 weekly sites for a total of 10 hours/week.
16352655|NCT00244361|Drug|rituximab|
16352656|NCT00244348|Drug|Oxaliplatin (via HAI)|
16352657|NCT00244348|Drug|5 Fluorouracil (systemic)|
16352658|NCT00244322|Drug|LY450139 dihydrate|
16352659|NCT00244322|Drug|placebo|
16352660|NCT00244309|Drug|tamsulosin and/or dutasteride|
16352661|NCT00244296|Drug|Duloxetine hydrochloride|
16352662|NCT00244296|Drug|placebo|
16352663|NCT00244283|Drug|Sevoflurane|
16352664|NCT00244283|Procedure|High thoracic epidural analgesia|
16352665|NCT00244270|Device|totally implantable vascular access device|totally implantable vascular access device
16352666|NCT00244257|Biological|GMA161|0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
16352667|NCT00244257|Biological|GMA161|0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
16352668|NCT00244257|Biological|GMA161|0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
16352669|NCT00244257|Biological|GMA161|1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
16352670|NCT00244257|Biological|GMA161|3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
16352671|NCT00244244|Drug|arimoclomol|
16352672|NCT00244231|Drug|Nidadd|
16352673|NCT00244218|Drug|tetrahydrobiopterin (BH4)|Either placebo or tetrahydrobiopterin (BH4) , 10mg/kg/day will be given for three months. Then the patient will be given three additional months of open label BH4 at the same rate.
16352674|NCT00244205|Procedure|Identifying genes methylated in urine|
16352675|NCT00244192|Drug|infliximab (Remicade)|
16352676|NCT00244179|Drug|interferon-gamma|
16352677|NCT00244179|Drug|infliximab|
16352678|NCT00244179|Drug|dmard|
16352679|NCT00244166|Drug|prednisolone|
16352680|NCT00244153|Drug|intraarticular morphine|
16352681|NCT00244153|Drug|intraarticular dexamethasone|
16352682|NCT00244140|Drug|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
16352683|NCT00244140|Drug|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
16352684|NCT00244127|Drug|Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)|
16352685|NCT00244114|Drug|blood draw|Single blood sample collected to perform histamine release assay.
16352686|NCT00244114|Procedure|Blood draw|Single blood sample collected to perform histamine release assay.
16352687|NCT00244101|Drug|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
16352688|NCT00244101|Device|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
16352689|NCT00244101|Drug|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
16352690|NCT00244075|Dietary Supplement|nutritional supplement|either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr
16352691|NCT00244075|Drug|recombinant human growth hormone (rcGH)|subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
16352692|NCT00244075|Behavioral|exercise|either dual leg press (3 sets of 8-12 repetitions) beginning 30 minutes prior to hemodialysis, or modified stepper (minimum of 15 minutes up to a maximum of 90 minutes, depending upon the patient's tolerance) beginning 15 minutes post initiation of hemodialysis
16352693|NCT00244062|Behavioral|counseling|
16352694|NCT00244049|Behavioral|counseling|Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.
16352695|NCT00244049|Other|Brief Intervention|Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.
16352696|NCT00244023|Drug|Testosterone gel|one sachet of 50 mg applied once a day, possibly titrated to two sachets if insufficient improvement of erectile function
16352699|NCT00244010|Device|Allogeneic stem cell transplant|Participants will receive a reduced intensity conditioning regimen consisting of fludarabine, thiotepa, melphalan, and OKT3 followed by an infusion of haploidentical stem cells. Rituximab will be administered within 24 hours of the infusion in an effort to prevent posttransplant lymphoproliferative disorder LPD. In addition to T-cell depletion of the donor product, participant will receive mycophenolate mofetil for prophylaxis of GVHD.
16352700|NCT00243997|Behavioral|Becoming Parents Program|Couple focused educational program for couples adding a new baby to the family-21 hours of workshops during pregnancy with two three hour workshops after the baby is born.
16352701|NCT00243984|Drug|topiramate|
16352702|NCT00243971|Drug|SPM 962|
16352703|NCT00243945|Drug|Rotigotine|
16352704|NCT00243932|Drug|coenzyme Q10|antioxidant and mitochondrial cofactor, given in capsules three times daily
16352705|NCT00243932|Drug|Placebo|Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily
16352706|NCT00243919|Behavioral|Early locomotor training program|The early locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 2 months post-stroke.
16352707|NCT00243919|Behavioral|Late locomotor training program|The late locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 6 months post-stroke.
16352708|NCT00243919|Behavioral|Home Exercise Program|Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
16352709|NCT00243906|Drug|Recombinant tissue plasminogen activator|Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
16352710|NCT00243906|Procedure|Low-intensity ultrasound|Delivery of additional IA rt-PA (up to 22 mg) in the setting of low-energy ultrasound via the EKOS microinfusion catheter at the site of IA occlusion in acute ischemic stroke patients with large strokes (NIHSS >/= 10) treated within 3 hours of symptoms onset.
16352711|NCT00243893|Drug|minocycline|Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
16352712|NCT00243893|Drug|doxycycline|Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
16352713|NCT00243880|Drug|lovastatin|investigators will treat the patients within 24 hours of symptom onset with short term high-dose lovastatin at escalating dosage. The escalating dosage levels will be 1, 3, 6, 8, and 10 mg/kg per day for 3 days.
16352714|NCT00243867|Drug|Taxoprexin|6. Other events that, based upon appropriate medical judgement, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes
16352715|NCT00243854|Drug|Tarceva|Tarceva: 100mg/day x 2 weeks (Days 1-14) +
16352716|NCT00243841|Radiation|Stereotactic Body Radiation|Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
16352717|NCT00243828|Device|Total Face Mask|
16352718|NCT00243815|Drug|ibuprofen|
16352719|NCT00243789|Drug|Pentoxifylline|"Participants will be randomized to receive either pentoxifylline or placebo in addition to their stable steroid therapy. Active drug and placebo preparations will be supplied as gel capsules of identical size, appearance and taste. Active drug capsules will contain one 400 mg time-release pentoxifylline tablet and inert filler. Placebo capsules will contain inert filler.
~Based on weight at screening, <30 mg will receive 1 400 capsule/day; 30-49 kg will receive two 400 capsules/day; 50 kg or greater will receive three 400 mg capsules/day."
16352720|NCT00243763|Drug|TKI258|
16352721|NCT00243750|Drug|Methotrexate|
16352722|NCT00243737|Drug|Artesunate-Mefloquine|
16352723|NCT00243724|Drug|Esomeprazole|
16352724|NCT00243711|Drug|Carboxymethylcellulose sodium and Glycerin|
16352725|NCT00243698|Drug|SonoVue (sulphur hexafluoride microbubbles)|One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
16352726|NCT00243685|Other|Laboratory Assay|Chemotherapy
16352727|NCT00243685|Other|Mick Assay|Chemotherapy doctor determined from results
16352728|NCT00243672|Drug|Atorvastatin|
16352729|NCT00243672|Drug|Gemfibrozil|
16352730|NCT00243659|Biological|ReFacto AF|
16352731|NCT00243646|Radiation|External beam radiation|All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
16352732|NCT00243646|Drug|Lupron|9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
16352733|NCT00243646|Drug|Casodex|9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
16352734|NCT00243633|Procedure|Real-time contrast-enhanced ultrasound sonography|
16352735|NCT00243620|Device|Vacuum therapy (device)|
16352736|NCT00243607|Other|hydrotherapy according to Kneipp rules|2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
16352737|NCT00243594|Biological|Peptide-pulsed dendritic cells|peptide-pulsed dendritic cells
16352738|NCT00243581|Behavioral|Dean Ornish Heart Disease Reversing Program|
16352739|NCT00243568|Drug|Vicriviroc|
16352740|NCT00243555|Procedure|allergy skin testing|
16352741|NCT00243555|Procedure|venepuncture|
16352742|NCT00243542|Drug|ACZONE Gel, 5%|
16352743|NCT00243542|Drug|Vehicle|
16352744|NCT00243529|Biological|autologous dendritic cell vaccine|
16352745|NCT00243516|Device|PREtest Consult|
16352746|NCT00243503|Drug|SU011248/Trastuzumab|SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
16352747|NCT00243490|Procedure|Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M|
16352748|NCT00243477|Drug|Escitalopram|Escitalopram 10mg or placebo once a day
16352749|NCT00243464|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
16352750|NCT00243451|Other|PET scan & fMRI|Subjects will be screened and if applicable for the study will be scheduled for an MRI. At the third visit they will complete the PET scan. They will return at 6, 12, 24, and 36 months and complete another PET scan at the last visit.
16352751|NCT00243438|Device|Multilink Vision™ Stent (CE-labeled)|Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.
16352752|NCT00243425|Procedure|Standard Quality Improvement|
16352753|NCT00243425|Procedure|Patient-centered Intervention|
16352754|NCT00243412|Drug|folate|Minimum of 1 mg/day oral (or folinic acid 5 mg/week)
16352755|NCT00243412|Drug|methotrexate|15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)
16352756|NCT00243412|Drug|methylprednisolone|100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion)
16352757|NCT00243412|Drug|Placebo|To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.
16352758|NCT00243412|Drug|Rituximab|500 mg or 1000 mg IV*2.
16352759|NCT00243399|Drug|Oxandrolone|Subjects will be started on a dose of oxandrolone 0.04 mg/kg/day orally, once/day. After 16 weeks, patients will be assessed for hematologic improvement. If this criteria is not met after 16 weeks, the dose will be escalated to 0.08 mg/kg/day. If no improvement is noted after 16 weeks on the escalated dose, oxandrolone therapy will be discontinued.
16352760|NCT00243386|Drug|Antihemophilic factor, recombinant, manufactured protein-free|Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator
16352761|NCT00243386|Drug|Antihemophilic factor, recombinant, manufactured protein-free|PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data
16352762|NCT00243373|Device|Barcode technology/eMAR|
16352763|NCT00243360|Behavioral|diagnostic and treatment clinical algorithms|
16352764|NCT00243347|Drug|AZD2171|oral tablet
16352765|NCT00243334|Other|Integration of advanced clinical decision support with ambulatory computerized physician order entry|Actiobable Reminders related to medication monitoring, preventive care and chronic disease management, and test result follow-up are administered either during the visit or between visits.
16352766|NCT00243321|Procedure|high dose-rate brachytherapy|High dose-rate brachytherapy
16352767|NCT00243321|Procedure|intensity-modulated radiation therapy|intensity-modulated radiation therapy
16352768|NCT00243308|Drug|Serine proteinase-1 (Serp-1)|
16352769|NCT00243295|Drug|rhBMP-2/CPM|
16352770|NCT00243282|Behavioral|Relaxation Response (instruction, pocket practice card prov)|
16352771|NCT00243282|Behavioral|Mindfulness training using model developed from UMass|
16352772|NCT00243269|Behavioral|Acupressure expectancy enhancement|"This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.
~This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea."
16352773|NCT00243256|Drug|Cholecalciferol|
16352774|NCT00243243|Drug|Recombinant Factor VIIa|intravenous infusion of Factor VIIa
16352775|NCT00243243|Drug|Placebo|intravenous infusion of placebo (sterile water)
16352776|NCT00243230|Drug|Vicriviroc 30 mg|Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).
16352777|NCT00243230|Drug|Vicriviroc 20 mg|Two tablets of vicriviroc 10 mg once daily for 48 weeks.
16352778|NCT00243230|Drug|Placebo|Three tablets of placebo once daily for 48 weeks.
16352779|NCT00243230|Drug|Placebo|Two tablets of placebo once daily for 48 weeks.
16352780|NCT00243230|Drug|Background ART Regimen|"An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually boosted with concomitant ritonavir."
16352781|NCT00243217|Drug|SPM 936|
16352782|NCT00243204|Drug|talabostat mesylate|
16352783|NCT00243204|Drug|docetaxel|
16352784|NCT00243191|Drug|imatinib mesylate|400 mg orally twice a day for 10 - 14 days
16352785|NCT00243178|Drug|clopidogrel (SR25990C)|75 mg once daily in combination with aspirin
16352786|NCT00243165|Behavioral|Lifemel honey intake every day|
16352787|NCT00243152|Drug|Lamotrigine|: 25mg and 50mg tablets
16352788|NCT00243152|Drug|Placebo (for Lamotrigine)|Sugar pill manufactured to mimic Lamotrigine tablets
16352789|NCT00243139|Device|Mandibular advancement device (activator)|
16352790|NCT00243126|Behavioral|Family-Based Risk Reduction Intervention|The intervention module topics include five modules and each module is 2 hours in length. The intervention will focus on the elements critical to HIV risk behavior change. These include: risk education (practical understanding of factors responsible for risk and behavior changes needed to reduce risk); threat personalization (accurate appraisal of personal risk based on behavior); self-efficacy (belief that one can implement risk reduction behavior changes and that if changes are made they will have protective value); skills acquisition (e.g., condom use, safer sex guidance, negotiation); cognitive problem-solving skills; and reinforcement.
16352791|NCT00243113|Drug|docetaxel|
16352792|NCT00243113|Radiation|radiation therapy|
16352793|NCT00243100|Drug|vorinostat|Given orally
16352794|NCT00243100|Drug|gemcitabine hydrochloride|Given IV
16352795|NCT00243087|Drug|BI 2536|
16352796|NCT00243074|Drug|cediranib maleate|Given orally
16352797|NCT00243074|Other|laboratory biomarker analysis|Correlative studies
16352798|NCT00243061|Drug|cediranib maleate|Given orally
16352799|NCT00243048|Dietary Supplement|soy protein isolate|
16352800|NCT00243048|Radiation|radiation therapy|
16352801|NCT00243035|Drug|bortezomib|Given IV
16352802|NCT00243035|Drug|tipifarnib|Given orally
16352803|NCT00243035|Other|laboratory biomarker analysis|Correlative studies
16362146|NCT00158405|Drug|Lamivudine (3TC)|
16352808|NCT00243009|Drug|mycophenolate mofetil|
16352809|NCT00243009|Procedure|allogeneic bone marrow transplantation|
16352810|NCT00243009|Procedure|peripheral blood stem cell transplantation|
16352811|NCT00243009|Radiation|radiation therapy|
16352812|NCT00242996|Biological|filgrastim|
16352813|NCT00242996|Biological|rituximab|
16352814|NCT00242996|Biological|sargramostim|
16352815|NCT00242996|Drug|carmustine|
16352816|NCT00242996|Drug|cyclophosphamide|
16352817|NCT00242996|Drug|etoposide|
16352818|NCT00242996|Procedure|adjuvant therapy|
16352819|NCT00242996|Procedure|bone marrow ablation with stem cell support|
16352820|NCT00242996|Procedure|peripheral blood stem cell transplantation|
16352821|NCT00242983|Procedure|quality-of-life assessment|
16352822|NCT00242970|Device|3-Dimensional Color Scanning|Color imaging of the face and neck.
16352823|NCT00242957|Behavioral|Intervention with Microfinance for AIDS and Gender Equity|
16352824|NCT00242944|Drug|Pitavastatin|Pitavastatin 4mg per day
16352825|NCT00242944|Drug|Atorvastatin|Atorvastatin 20mg per day
16352826|NCT00242931|Other|Nonmyeloablative stem cell conditioning regimen|"Conditioning:
~Fludarabine 30 mg/m2/day x 3, day -4 to day -2 TBI 200 cGy x 1, day 0
~Hematopoeitic Stem Cell Transplantation:
~Infusion of peripheral blood stem cells, day 0
~Immunosuppression:
~For related donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For related donors: mycophenolate mofetil (MMF) 15 mg/kg p.o. q 12 hours, day 0 to day +27, then stop
~For unrelated donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For unrelated donors: mycophenolate mofetil (MMF) 15 mg/kg tid day +0 to day +29, 15 mg/kg bid day +30 to day +149, and then taper by 25% per week from day +150 to day +180. Discontinue by day +181."
16352827|NCT00242918|Drug|docetaxel|
16352828|NCT00242918|Drug|ZD1839|
16352829|NCT00242905|Behavioral|Study of memory using MRI|Study of memory using MRI
16352830|NCT00242892|Procedure|Intra coronary measures of pressure|Intra coronary measures of pressure
16352831|NCT00242879|Drug|Physician determined comparator PI + ritonavir|
16352832|NCT00242879|Drug|GW640385 + ritonavir|
16352833|NCT00242866|Drug|GW274150|The tablets used in this study will contain either 5mg or 30mg of GW274150
16352834|NCT00242866|Other|Placebo|Placebo to Match GW274150
16352835|NCT00242853|Procedure|Power doppler ultrasonography|
16352836|NCT00242853|Procedure|High frequency ultrasonography|
16352837|NCT00242853|Procedure|Exhaled nitric oxide assessment|
16352838|NCT00242840|Drug|No intervention; Observational study|
16352839|NCT00242827|Drug|Oral CEP-701|
16352840|NCT00242814|Drug|Micardis|
16352841|NCT00242814|Drug|Amlodipine|
16352842|NCT00242814|Procedure|Abdominal biopsy|
16352843|NCT00242801|Drug|Gefitinib|
16352844|NCT00242788|Drug|Gefitinib and capecitabine|
16352845|NCT00242775|Drug|Budesonide/formoterol Turbuhaler|
16352846|NCT00242775|Drug|Salmeterol/fluticasone Diskus|
16352847|NCT00242762|Drug|ZD1839 (IRESSA™)|
16352848|NCT00242762|Drug|Docetaxel|
16352849|NCT00242762|Drug|Cisplatin|
16352850|NCT00242749|Drug|Gefitinib, Cisplatin and Radiotherapy|
16352851|NCT00242736|Drug|Esomeprazole|
16352852|NCT00242710|Drug|Bazedoxifene/Conjugated Estrogen|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
16352853|NCT00242710|Drug|Bazedoxifene/Conjugated Estrogen|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
16352854|NCT00242710|Drug|CE 0.45 mg/MPA 1.5mg|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
16352855|NCT00242710|Other|Placebo|Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
16352856|NCT00242697|Procedure|spinal analgesia and anesthesia for coronary artery surgery|
16352857|NCT00242671|Procedure|Isocapnic Hyperponea|
16352858|NCT00242658|Behavioral|Tailored Physical Activity Intervention|Tailored physical activity computer reports will be provided to patients and physicians.
16352859|NCT00242645|Behavioral|Health Information|
16352860|NCT00242645|Behavioral|Preventive Services|
16352861|NCT00242645|Behavioral|Computer tailored information|
16352862|NCT00242632|Drug|Namenda|Namenda has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating those at risk for cognitive decline without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that memantine may offer neurocognitive benefits to this population, as well. Participants are asked to take medication for six months, complete neuropsychological testing, and one blood draw.
16352863|NCT00242619|Drug|rosiglitazone|Rosiglitazone was administered at two different doses over the 12-week period.
16352864|NCT00242606|Drug|Lamotrigine|titrate to 200mg over 10 weeks and maintained until end of week 26
16352865|NCT00242606|Drug|Levetiracetam|titrate to 2000mg/day over 22 days, maintain until the end of week 26
16352866|NCT00242593|Drug|Rosiglitazone|4 mg twice daily oral rosiglitazone or placebo pill for 18 months
16352867|NCT00242580|Drug|Verteporfin photodynamic therapy|After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
16352868|NCT00242580|Drug|Pegaptanib|Pegaptanib sodium 0.3 mg administered by intravitreal injection.
16352869|NCT00242580|Drug|Triamcinolone acetonide|Triamcinolone acetonide administered by intravitreal injection.
16352930|NCT00241969|Behavioral|Education and Attention Control|This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
16352931|NCT00241943|Procedure|Hepatitis C educational video|
16352932|NCT00241930|Behavioral|Integrating drug treatment into HIV services|
16352870|NCT00242567|Drug|Zoledronic Acid|"Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.
~After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.
~The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes."
16352871|NCT00242567|Drug|Androgen Deprivation Therapy (ADT)|Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.
16352872|NCT00242554|Drug|Zoledronic acid|
16352873|NCT00242541|Drug|Octreotide acetate|
16352874|NCT00242528|Drug|Zoledronic acid|
16352875|NCT00242515|Procedure|CD8+ T-cell depleted donor lymphocyte infusion|
16352876|NCT00242502|Drug|Bevacizumab (Avastin)|10 mg/kg IV every 14 days, repeat cycle every 28 days
16352877|NCT00242502|Drug|Erlotinib|150 mg orally every day continuous dosing, repeat cycle every 28 days
16352878|NCT00242489|Drug|MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)|
16352879|NCT00242489|Drug|Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks|
16352880|NCT00242476|Drug|MK0822A|
16352881|NCT00242463|Drug|Nandrolone (anabolic steroid)|
16352882|NCT00242463|Drug|Placebo|
16352883|NCT00242450|Drug|Metoclopramide|
16352884|NCT00242437|Device|Hemostatic matrix|
16352885|NCT00242437|Device|bovine thrombin|
16352886|NCT00242424|Biological|2005-2006 trivalent inactivated influenza vaccine|Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later.
16352887|NCT00242411|Drug|Budesonide/Formoterol Turbuhaler|
16352888|NCT00242411|Drug|Conventional Best Asthma Therapy|
16352889|NCT00242398|Device|AN69 ST|
16352890|NCT00242385|Biological|Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor|Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
16352891|NCT00242385|Biological|Dose of 60 mg/kg alpha1-proteinase inhibitor|Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
16352892|NCT00242372|Drug|Tesaglitazar 0.5|
16352893|NCT00242372|Drug|Insulin at least 30 units/day|
16352894|NCT00242359|Drug|omalizumab|
16352895|NCT00242346|Drug|candesartan cilexetil|
16352896|NCT00242333|Drug|AD 237|
16352897|NCT00242320|Drug|Roflumilast|to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
16352898|NCT00242320|Drug|Placebo|
16352899|NCT00242307|Drug|Roflumilast|
16352900|NCT00242294|Drug|Roflumilast|
16352901|NCT00242281|Drug|APC-111 MP Tablet, 775 mg|
16352902|NCT00242268|Drug|Simvastatin|
16352903|NCT00242229|Drug|DVS-233 SR|
16352904|NCT00242216|Drug|ritonavir-boosted atazanavir|100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
16352905|NCT00242216|Drug|ritonavir-boosted fosamprenavir|100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
16352906|NCT00242203|Drug|Zometa|
16352907|NCT00242203|Drug|Epirubicin|
16352908|NCT00242203|Drug|Docetaxel|
16352909|NCT00242203|Drug|Trastuzumab|ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH
16352910|NCT00242203|Radiation|External beam radiation|
16352911|NCT00242203|Procedure|Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection|
16352912|NCT00242190|Drug|oxaliplatin|
16352913|NCT00242190|Drug|gemcitabine|
16352914|NCT00242190|Procedure|radiation therapy|
16352915|NCT00242177|Drug|ACTOS (Pioglitazone)|
16352916|NCT00242164|Drug|Dialysate Magnesium (Concentration)|
16352917|NCT00242138|Behavioral|Erectile Dysfunction|
16352918|NCT00242112|Procedure|MRI Prostate|
16352919|NCT00242099|Procedure|Monitoring - blood samples drawn to test for HHV-6 and HHV-7|
16352920|NCT00242086|Procedure|CT, PET and MRI|
16352921|NCT00242073|Procedure|MRI Prostate|
16352922|NCT00242060|Procedure|MRI|
16352923|NCT00242047|Biological|Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).|
16352924|NCT00242034|Procedure|CT and MRI with contrast|
16352925|NCT00242021|Behavioral|Fatty acid composition of a margarine (spread)|
16352926|NCT00242008|Drug|Rotigotine|
16352927|NCT00241995|Drug|Anticonvulsants|
16352928|NCT00241982|Drug|long-circulating liposomal prednisolone|
16352929|NCT00241969|Behavioral|Behavioral and Nutrition Treatment|This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
16353040|NCT00240825|Drug|Acetaminophen|
16352933|NCT00241917|Behavioral|Hepatitis C educational video|
16352934|NCT00241917|Other|Video|Prevention education video about hepatitis C
16352935|NCT00241904|Behavioral|Lifestyle Changes|Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise
16352936|NCT00241904|Drug|Antiplatelet Agents|Aspirin 81 mg q day
16352937|NCT00241904|Drug|Beta Blocker|Oral medication
16352938|NCT00241904|Drug|ACE Inhibitors|Oral medications, received 1-2 times per day
16352939|NCT00241891|Behavioral|Single behavior intervention|Focused on changing beverage choices which may have a significant impact on weight.
16352940|NCT00241891|Behavioral|Multiple behavior interventions|Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
16352941|NCT00241891|Behavioral|Control Intervention unrelated to weight|Focused on standard intervention strategies unrelated to weight including bullying prevention.
16352942|NCT00241878|Behavioral|Teacher-Delivered Weight Control Intervention|The teacher-delivered weight control intervention (TD-WCI) is implemented over 14 weeks with three lessons per week. Many lessons include the use of colorful, friendly, hand-made puppets that represent the seven food groups of the food pyramid (Miss Grain, Miss Fruit, Mr. Vegetable, Mr. Protein, Miss Dairy, Mr. Fat and Miss Sugar). Please see Appendix IX for complete curriculum and pictures of puppets. There are three 40-minute lessons per week that consist of a 15-20 minutes interactive healthy eating and exercise didactic session and then 20 minutes of ongoing physical activity (5 minutes warm-up, 15 minutes aerobic activity composed of a number of games and dances with music, 5 minutes cool-down). In addition to the child-based curriculum the WCI has parent newsletters. These newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
16352943|NCT00241878|Behavioral|Teacher-Delivered General Health Intervention|The teacher-delivered general health intervention (TD-GHI) serves as the control group in the proposed study. TD-GHI is a general health intervention that is similar in structure and length to TD-WCI. Topics include those related to general health and safety, such as car safety, being a good friend, poison safety, disease prevention, etc. An example of an activity is the 911 emergency call. The children learn what 911 is and what would be an appropriate call. They then practice calling 911 on play telephones and relating the important information: nature of the emergency, their name, their address, etc. They learn also to stay on the phone with the 911 dispatcher until someone comes to help them. In addition to the child-based curriculum the GHI has parent newsletters. Like TD-WCI these newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
16352944|NCT00241852|Behavioral|Asthma: It's a Family Affair!|Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease. The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
16352945|NCT00241852|Behavioral|Asthma and Stress Comparator|Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress. The children will also participate in a single school-based session on similar topics. Both caregivers and students will learn basic asthma facts.
16352946|NCT00241839|Drug|Allopurinol|Allopurinol (300 mg capsule) was given for 8-10 weeks compared to placebo group after initial baseline testing. After two weeks on the Allopurinol, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the Allopurinol dosage was increased to 600mg (two 300 mg capsules)for the duration of the trial, 6-8 weeks.
16352947|NCT00241839|Drug|Placebo|Placebo capsule (matched in appearance for Allopurinol and labeled 300mg) was given for 8-10 weeks compared to the Allopurinol group after initial baseline testing. After two weeks on the placebo, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the placebo dosage was increased to 600mg (two 300 mg capsules)for the duration of the study, 6-8 weeks.
16352948|NCT00241839|Drug|Chlorthalidone|Chlorthalidone 25 mg was given daily for 5 weeks before baseline visit for testing and continued through out the study.
16352949|NCT00241839|Drug|Potassium chloride|Potassium Chloride 40-50meq was given daily for 5 weeks before baseline visit for testing and continued through out the study.
16352950|NCT00241826|Procedure|Magnetic Resonance Angiography|Participants will undergo magnetic resonance angiography.
16352951|NCT00241826|Procedure|Magnetic Resonance Venography|Participants will undergo magnetic resonance venography.
16352952|NCT00241813|Behavioral|Mindfulness Meditation (MM) Program|Participants will take part in a mindfulness meditation (MM) program.
16352953|NCT00241813|Behavioral|Health Education Control Program (CTL)|Participants will take part in a health education control program (CTL)
16352954|NCT00241813|Behavioral|Lifeskills Program (LP)|Participants will take part in a lifeskills program (LP).
16352955|NCT00241722|Drug|Alvimopan|
16352956|NCT00241722|Drug|Placebo|
16352957|NCT00241670|Drug|5-aminolevulinic acid (5-ALA)|1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
16352958|NCT00241657|Biological|BCG|
16352959|NCT00241644|Biological|Rotarix™|Two or Three doses, oral administration
16352960|NCT00241644|Biological|Placebo|One or three doses, oral administration.
16352961|NCT00241631|Drug|Fluticasone Propionate|500 u
16352962|NCT00241631|Drug|placebo|
16352963|NCT00241631|Drug|Theophylline|Theophylline placebo capcule
16352964|NCT00241618|Drug|Pegylated interferon alpha 2|
16352965|NCT00241618|Drug|Ribavirin|
16352966|NCT00241605|Drug|rosiglitazone/metformin|
16352967|NCT00241592|Drug|Cannabis|
16352968|NCT00241579|Drug|Smoked Cannabis|
16352969|NCT00241566|Device|implantation of stimulator|
16352970|NCT00241553|Drug|Esomeprazole|
16352971|NCT00241540|Drug|Esomeprazole|
16352972|NCT00241527|Drug|Esomeprazole|
16352973|NCT00241514|Drug|Esomeprazole|
16352974|NCT00241501|Drug|Esomeprazole (Nexium)|
16352975|NCT00241488|Drug|Rosuvastatin|
16352976|NCT00241475|Drug|Gefitinib|
16352977|NCT00241449|Drug|Fulvestrant|intramuscular injection 250 mg
16352978|NCT00241449|Drug|Tamoxifen|20 mg oral tablet
16352979|NCT00241436|Drug|Anastrozole (ARIMIDEX™)|
16352980|NCT00241423|Drug|exenatide|subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
16352981|NCT00241423|Drug|Placebo|subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week
16352982|NCT00241410|Biological|OralvacB2MPL|Comparison of different dosages of drug
16352983|NCT00241384|Procedure|External beam radiation|
16352984|NCT00241384|Procedure|Pd-103|
16352985|NCT00241371|Drug|Clofarabine|
16352986|NCT00241358|Drug|AMD3100|
16352987|NCT00241358|Procedure|Stem Cell Transplant|
16352988|NCT00241345|Drug|Valganciclovir|
16352989|NCT00241345|Drug|Ganciclovir|
16352990|NCT00241332|Drug|fentanyl|
16352991|NCT00241319|Drug|R89674 (generic name not yet established)|
16352992|NCT00241280|Device|etafilcon A|
16352993|NCT00241280|Device|galyfilcon A|
16352994|NCT00241267|Device|Dedicated ultrasonographic probe during bronchoscopy|
16352995|NCT00241254|Drug|Cyclophosphamide (drug)|IV cyclophosphamide infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
16352996|NCT00241254|Drug|Methylprednisolone (drug)|Control group : IV methylprednisolone infusion administered every 4 weeks during 1 year and every 8 weeks during 1 year.
16352997|NCT00241241|Drug|pegylated interferon-alfa 2a|
16352998|NCT00241228|Device|Venovenous haemofiltration (renal replacement therapy)|High Volume ultra filtration (70 ml/kg/h)
16352999|NCT00241228|Device|Venovenous haemofiltration (renal replacement therapy)|Conventional Volume (35 ml/kg/h)
16353000|NCT00241215|Drug|Botulinum toxin serotype A|
16353001|NCT00241202|Behavioral|Symptom Management Manual|Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.
16353002|NCT00241189|Drug|rapamycin|
16353003|NCT00241189|Drug|methotrexate|
16353004|NCT00241176|Drug|Aripiprazole|Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS & CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day
16353005|NCT00241163|Procedure|Fibrinogen (human) + thrombin (human) (TachoSil)|
16353006|NCT00241150|Drug|VALSARTAN|
16353007|NCT00241137|Drug|valsartan|
16353008|NCT00241124|Drug|valsartan|
16353009|NCT00241124|Drug|lisinopril|
16353010|NCT00241111|Drug|zoledronic acid|
16353011|NCT00241098|Drug|valsartan|
16353012|NCT00241085|Drug|valsartan|
16353013|NCT00241072|Drug|valsartan|24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
16353014|NCT00241059|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353015|NCT00241046|Drug|Letrozole|
16353016|NCT00241020|Drug|Octreotide|
16353017|NCT00241007|Drug|VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE|
16353018|NCT00240994|Drug|Alemtuzumab|Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.
16353019|NCT00240994|Drug|Tacrolimus|Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
16353020|NCT00240994|Drug|Mycophenolate mofetil|Per recommendation
16353021|NCT00240994|Drug|Sirolimus|Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
16353022|NCT00240981|Drug|Topical testosterone gel 1% (active formulation)|Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
16353023|NCT00240981|Drug|Topical gel (placebo formulation)|Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
16353024|NCT00240968|Biological|Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)|A monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit¿¿dose vials containing either 30-mcg/mL A/H5N1 HA or 90-mcg/mL A/H5N1 HA. Subjects will receive 1 of 4 dose levels of vaccine (7.5, 15, 45, or 90 mcg) administered intramuscularly.
16353025|NCT00240955|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16353026|NCT00240942|Drug|Letrozole|
16353027|NCT00240929|Drug|MEDI-493|Active Comparator
16353028|NCT00240916|Biological|Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous)|
16353029|NCT00240916|Biological|MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)|
16353030|NCT00240903|Biological|Influenza A/Vietnam/1203/2004 (H5N1; sanofi pasteur)|
16353031|NCT00240877|Biological|AV024|0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
16353032|NCT00240877|Other|Placebo|Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
16353033|NCT00240864|Drug|placebo|
16353034|NCT00240864|Drug|acetaminophen|
16353035|NCT00240864|Drug|ibuprofen|
16353036|NCT00240851|Drug|acetaminophen extended release|
16353037|NCT00240838|Drug|acetaminophen extended release caplets|
16353038|NCT00240825|Drug|Ibuprofen|
16353039|NCT00240825|Drug|Placebo|
16353041|NCT00240812|Drug|ibuprofen; pseudoephedrine HCl|
16353042|NCT00240799|Drug|acetaminophen extended release|
16353043|NCT00240799|Drug|placebo|
16353044|NCT00240786|Drug|acetaminophen extended release|
16353045|NCT00240773|Drug|acetaminophen|4 grams daily for six months
16353046|NCT00240773|Drug|naproxen|750 mg daily for 12 months
16353047|NCT00240773|Drug|acetaminophen|4 grams daily for 12 months
16353048|NCT00240773|Drug|naproxen|750 mg daily for six months
16353049|NCT00240760|Drug|Memantine Hydrochloride|
16353050|NCT00240747|Drug|Synercid|
16353051|NCT00240734|Drug|Epoetin alfa|
16353052|NCT00240721|Drug|topiramate|
16353053|NCT00240708|Drug|risperidone|
16353054|NCT00240695|Drug|galantamine hydrobromide|
16353055|NCT00240682|Drug|cetuximab|Dosage form: bottles of 50 ml, 2 mg/ml; Dosage:400 mg/m2 initial dose followed by 250 mg/m2 by infusion every week; Number of Cycles : until progression or unacceptable toxicity develops.
16353056|NCT00240669|Device|Resorbable device PLLA/PGA|
16353057|NCT00240669|Device|Titanium device|
16353058|NCT00240656|Drug|spironolactone captopril carvedilol|
16353059|NCT00240643|Drug|SB424323|
16353060|NCT00240630|Drug|sumatriptan succinate/naproxen sodium|Combination Tablet of Treximet
16353061|NCT00240630|Drug|placebo|placebo to match
16353062|NCT00240617|Drug|sumatriptan succinate/naproxen sodium|comparator
16353063|NCT00240617|Drug|placebo|placebo to match
16353064|NCT00240604|Drug|Rosiglitazone|4 mg rosiglitazone per day
16353065|NCT00240565|Drug|Tositumomab 450 mg|Unlabeled TST
16353066|NCT00240565|Drug|Tositumomab 35 mg|TST labeled with 185 megaBecqueral (mbq) of iodine 131
16353067|NCT00240552|Drug|fosamprenavir|
16353068|NCT00240552|Drug|Telzir®|
16353069|NCT00240539|Procedure|Blood sampling|A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.
16353070|NCT00240526|Biological|Engerix™ -B|3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
16353071|NCT00240526|Biological|Hepatitis B immunoglobulin (HBIg)|1 intramuscular injections at birth (primary study)
16353072|NCT00240513|Drug|Minocycline|100 mg capsules OD for 3 months
16353073|NCT00240513|Drug|Minocycline plus tretinoin|100mg OD Minocycline for 12 weeks plus OD Topical tretinoin 0.01% for 12 weeks Followed by topical tretinoin 0.01% OD for 12 weeks alone
16353074|NCT00240500|Biological|Engerix™-B|In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.
16353075|NCT00240487|Drug|Nitric Oxide|Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.
16353076|NCT00240487|Other|No Intervention|Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
16353077|NCT00240474|Drug|Telmisartan 80 mg + hydrochlorothiazide 12.5 mg|
16353078|NCT00240474|Drug|Amlodipine 10 mg + hydrochlorothiazide 12.5 mg|
16353079|NCT00240461|Dietary Supplement|COLD-fX natural health product|200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
16353080|NCT00240461|Dietary Supplement|COLD-fX|400 mg COLD-fX natural health product 2 times daily for 6 months
16353081|NCT00240461|Other|Placebo|crystalline substance 200 mg twice daily for 6 months
16353082|NCT00240448|Drug|telmisartan 80 mg/hydrochlorothiazide 25 mg|
16353083|NCT00240448|Drug|valsartan 160 mg/hydrochlorothiazide 25 mg|
16353084|NCT00240448|Drug|placebo|
16353085|NCT00240435|Device|5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
16353086|NCT00240435|Device|10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
16353087|NCT00240422|Drug|Telmisartan|
16353088|NCT00240422|Drug|Ramipril|
16353089|NCT00240409|Drug|Pramipexole|
16353090|NCT00240409|Drug|Bromocriptine|
16353091|NCT00240396|Drug|Narcotics alone|
16353092|NCT00240396|Drug|Narcotics and NSAIDS|
16353093|NCT00240383|Drug|Muraglitazar|
16353094|NCT00240370|Drug|Muraglitazar|
16353095|NCT00240357|Procedure|Lifestyle Regulation|
16353096|NCT00240331|Drug|10mg Rosuvastatin|
16353097|NCT00240331|Drug|Placebo|
16353098|NCT00240318|Drug|Rosuvastatin calcium|
16353099|NCT00240305|Drug|Rosuvastatin|
16353100|NCT00240292|Drug|Rosuvastatin|
16353101|NCT00240279|Drug|Rosuvastatin|
16353102|NCT00240279|Procedure|aortic pulse wave velocity measurements|
16353103|NCT00240266|Drug|Rosuvastatin|
16353104|NCT00240253|Drug|pramlintide acetate|Clear, colorless, sterile solution for SC injection
16353105|NCT00240227|Drug|Prazosin|FDA approved medication for hypertension
16353106|NCT00240227|Drug|placebo|
16353107|NCT00240214|Drug|sirolimus|Tablet, dosage is determined by trough level
16353108|NCT00240188|Procedure|Open mesh repair of ventral incisional hernia|For the open procedure, the technique, as described by Chevrel and others was adopted.
16353109|NCT00240188|Procedure|Laparoscopic mesh repair of ventral incisional hernia|For the laparoscopic repair, the method of Gagner was adopted
16353110|NCT00240175|Other|No Intervention|No Intervention
16353111|NCT00240162|Drug|PTK787/ZK 222584|
16353112|NCT00240149|Drug|Regular Insulin via Insulin-Glucose Algorithm|
16353113|NCT00240123|Drug|Benadryl versus Placebo|
16353114|NCT00240110|Drug|Valproate|Valproate with dose titration to achieve blood levels within the therapeutic range
16353115|NCT00240110|Drug|Placebo|Control arm
16353116|NCT00240110|Drug|Lithium Carbonate|All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
16353253|NCT00238914|Behavioral|Behavioral Naltrexone Therapy (BNT)|a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy
16353117|NCT00240097|Drug|Intervention A: Irinotecan; Oxaliplatin; Neulasta|Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
16353118|NCT00240097|Drug|Intervention B: Etoposide; Carboplatin; Neulasta|Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
16353119|NCT00240084|Drug|nesiritide (Natrecor(TM))|administration of IV nesiritide
16353120|NCT00240071|Drug|Avastin|All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.
16353121|NCT00240071|Drug|Hormonal therapy|aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)
16353122|NCT00240058|Drug|Regional phenylephrine arterial infusion, Nitric Oxide Clamp|
16353123|NCT00240045|Drug|Midodrine, albumin, octreotide LAR|
16353124|NCT00240045|Drug|midodrine, octreotide, albumin|midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly
16353125|NCT00240032|Drug|glatiramer acetate injection with oral cetirizine hydrochloride|Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet
16353126|NCT00240032|Drug|glatiramer acetate with placebo|Copaxone® injection 20 mg, oral placebo
16353127|NCT00240019|Drug|Addition of furosemide 20 mg oral bid to baseline regimen|
16353128|NCT00240006|Procedure|Shared Solutions® plus MS Center v. Shared Solutions®|Copaxone
16353129|NCT00239993|Drug|glatiramer acetate|
16353130|NCT00239993|Procedure|Warm compress prior to injection of glatiramer acetate|
16353131|NCT00239980|Drug|dalteparin|50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
16353132|NCT00239967|Drug|Rimonabant (SR141716)|
16353133|NCT00239967|Drug|Placebo|
16353134|NCT00239954|Drug|Escitalopram|
16353135|NCT00239928|Drug|pegaptanib sodium|1 drop per dosed eye per protocol.
16353136|NCT00239915|Drug|Pagoclone|
16353137|NCT00239902|Drug|FTY720|
16353138|NCT00239889|Drug|Salmon calcitonin|
16353139|NCT00239876|Drug|FTY720|
16353140|NCT00239863|Drug|FTY720|
16353141|NCT00239850|Behavioral|lifestyle changes|
16353142|NCT00239837|Behavioral|Middle School Success Intervention (MSS)|This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school.
16353143|NCT00239824|Behavioral|Strength training of the pelvic floor muscles|"Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily.
~Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist."
16353144|NCT00239824|Behavioral|strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist|
16353145|NCT00239811|Drug|FTY720|
16353146|NCT00239798|Drug|FTY720|
16353147|NCT00239785|Drug|FTY720|
16353148|NCT00239772|Behavioral|Cognitive Processing Therapy|
16353149|NCT00239772|Behavioral|Prolonged Exposure Therapy|
16353150|NCT00239746|Drug|Ibuprofen|200mg taken orally daily for 6-12 weeks
16353151|NCT00239746|Drug|Placebo|200mg matched placebo taken orally daily for 6-12 weeks
16353152|NCT00239733|Drug|Anti-D|30-minute infusion administered in an outpatient setting
16353153|NCT00239720|Drug|hOKT3gamma1(Ala-Ala)|Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
16353154|NCT00239720|Drug|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
16353155|NCT00239707|Drug|GIP|One-time 20 ng/kg/min infusion over 3 hours
16353156|NCT00239707|Drug|Modified GIP|One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl
16353157|NCT00239707|Drug|Normal Saline|one-time infusion over 3 hours
16353158|NCT00239694|Biological|Pneumococcal Vaccine|One time preventative vaccine
16353159|NCT00239694|Biological|Meningococcal Vaccine|One time preventative vaccine
16353160|NCT00239681|Drug|Rosuvastatin|Oral
16353161|NCT00239681|Other|Placebo|Oral
16353162|NCT00239655|Drug|MK0812|
16353163|NCT00239642|Drug|Venofer (iron sucrose injection)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
16353164|NCT00239642|Drug|Venofer (iron sucrose injection)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
16353165|NCT00239642|Drug|Venofer (iron sucrose injection)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
16353166|NCT00239629|Drug|Teriparatide|
16353167|NCT00239629|Drug|Strontium ranelate|
16353168|NCT00239629|Procedure|Transiliac bone biopsy|
16353169|NCT00239616|Drug|iron sucrose injection USP|
16353170|NCT00239603|Device|OV-Watch|
16353171|NCT00239590|Drug|Testosterone undecanoate|Licensed for androgen deficiency
16353172|NCT00239577|Biological|Live attenuated tetravalent dengue vaccine|Live attenuated tetravalent dengue vaccine
16353173|NCT00239577|Biological|Placebo|Placebo
16353174|NCT00239564|Drug|IPX054 100 mg|IPX054 containing 25 mg carbidopa and 100 mg levodopa
16353175|NCT00239564|Drug|IPX054 150 mg|IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
16353176|NCT00239564|Drug|IPX054 200 mg|CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
16353177|NCT00239564|Drug|IPX054 250 mg|CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
16353178|NCT00239564|Drug|IPX054 300 mg|CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
16353254|NCT00238914|Behavioral|Compliance Enhancement (CE)|a controlled therapy intended to simulate outpatient psychiatric care.
16353179|NCT00239551|Drug|Prevacid|Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 & EGD with biopsy at 8 weeks
16353180|NCT00239538|Drug|telmisartan combined with hydrochlorothiazide (80/12.5 mg)|
16353181|NCT00239538|Drug|valsartan combined with hydrochlorothiazide (160/12.5mg)|
16353182|NCT00239525|Device|3-D ultrasound scanner|The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull.
16353183|NCT00239525|Drug|Perflutren Protein-Type A Microspheres for injection|Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
16353184|NCT00239512|Drug|Indomethacin and Ibuprofen|
16353185|NCT00239499|Drug|Tiotropium|
16353186|NCT00239499|Drug|Salmeterol plus Fluticasone|
16353187|NCT00239486|Drug|Pramipexole|
16353188|NCT00239473|Device|5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
16353189|NCT00239473|Device|10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|
16353190|NCT00239460|Drug|Tiotropium|
16353191|NCT00239447|Drug|Tiotropium|
16353192|NCT00239447|Device|HandiHaler|
16353193|NCT00239447|Device|Respimat SMI|
16353194|NCT00239434|Drug|tiotropium inhalation powder capsule|
16353195|NCT00239434|Drug|ipratropium bromide Metered Dose Inhaler|
16353196|NCT00239421|Drug|Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule)|
16353197|NCT00239421|Drug|Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d.|
16353198|NCT00239408|Device|Pulmonary function Testing|
16353199|NCT00239408|Drug|tiotropium bromide|
16353200|NCT00239395|Drug|Meloxicam ampoule|
16353201|NCT00239395|Drug|Meloxicam tablet|
16353202|NCT00239382|Drug|Meloxicam ampoule|
16353203|NCT00239382|Drug|Meloxicam tablet|
16353204|NCT00239369|Drug|Fixed dose combination telmisartan 80 mg + HCTZ 25 mg|
16353205|NCT00239369|Drug|Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg|
16353206|NCT00239356|Drug|Aripiprazole|Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country
16353207|NCT00239343|Drug|gefitinib|
16353208|NCT00239330|Drug|Rosuvastatin|
16353209|NCT00239330|Drug|Atorvastatin|
16353210|NCT00239317|Drug|Tamusulosin|
16353211|NCT00239304|Drug|Gefitinib|
16353212|NCT00239304|Drug|Cisplatin|
16353213|NCT00239304|Procedure|Radiotherapy|
16353214|NCT00239291|Drug|Gefitinib, radiotherapy|
16353215|NCT00239278|Drug|budesonide/formoterol, 2x 200/6 microgram. 4 times daily|
16353216|NCT00239278|Drug|prednisolone, 30 mg once daily and placebo|
16353217|NCT00239265|Drug|Tamuslosin|
16353218|NCT00239252|Drug|Interferon alfacon-1|
16353219|NCT00239239|Drug|Darbepoetin alfa|darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110
16353220|NCT00239226|Procedure|IAS pacing - study group|site of implant and permanent pacing
16353221|NCT00239226|Procedure|IAS pacing control group|site of implant and permanent pacing
16353222|NCT00239226|Procedure|Pacing RAA study group|site of implant and permanent pacing
16353223|NCT00239226|Procedure|Pacing RAA control group|site of implant and permanent pacing
16353224|NCT00239213|Drug|catechin extracts (health food)|
16353225|NCT00239200|Drug|Lapatinib|
16353226|NCT00239187|Drug|E1 and G1|
16353227|NCT00239174|Drug|SR147778|
16353228|NCT00239161|Drug|Levofloxacin|
16353229|NCT00239148|Drug|E1 and G1|
16353230|NCT00239135|Drug|PEP005|
16353231|NCT00239122|Behavioral|Recovery Therapy (Cognitive Behaviour Therapy for psychosis)|
16353232|NCT00239109|Drug|Ziprasidone|
16353233|NCT00239109|Drug|Olanzapine|
16353234|NCT00239109|Procedure|Scales|
16353235|NCT00239109|Procedure|measures of the body (Weight...)|
16353236|NCT00239109|Procedure|Serum analysis|
16353237|NCT00239096|Drug|losartan (drug)|
16353238|NCT00239083|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353239|NCT00239070|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353240|NCT00239057|Drug|Enteric-Coated Mycophenolate Sodium|
16353241|NCT00239044|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16353242|NCT00239031|Drug|Enteric-Coated Mycophenolate Sodium|Enteric-Coated Mycophenolate Sodium
16353243|NCT00239018|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353244|NCT00239005|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353245|NCT00239005|Drug|Mycophenolate Mofetil (MMF)|
16353246|NCT00238992|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16353247|NCT00238979|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353248|NCT00238966|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353249|NCT00238953|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353250|NCT00238940|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16353251|NCT00238927|Drug|inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days)|
16353252|NCT00238914|Drug|Naltrexone|50mg of oral naltrexone daily
16353256|NCT00238888|Procedure|asthma control awareness|Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit
16353257|NCT00238888|Procedure|Usual care|Recommendation for asthma education and/or follow-up at the physician's discretion
16353258|NCT00238875|Procedure|stereotactic body radiation therapy|Procedure/Surgery: stereotactic body radiation therapy
16353259|NCT00238862|Procedure|Amniotic membrane transplantation|
16353260|NCT00238862|Drug|Autologous serum/BSS 20%|
16353261|NCT00238849|Drug|Oxaliplatin|
16353262|NCT00238836|Behavioral|Self-management of chronic illness|
16353263|NCT00238797|Drug|Gefitinib|
16353264|NCT00238784|Drug|Budesonide/formoterol Turbuhaler|
16353265|NCT00238758|Drug|Omega-3 Polyunsaturated Fatty Acids|
16353266|NCT00238745|Drug|Bazedoxifene|
16353267|NCT00238745|Drug|Placebo|
16353268|NCT00238732|Drug|Bazedoxifene/Conjugated Estrogen|
16353269|NCT00238719|Drug|Venlafaxine ER|
16353270|NCT00238706|Device|Radiofrequency ablation|
16353271|NCT00238680|Behavioral|Bladder rehabilitation|
16353272|NCT00238680|Behavioral|Bladder rehabilitation with programmable timer|
16353273|NCT00238667|Drug|Antiplatelet (Aspirin, Dipyridamole, clopidogrel)|
16353274|NCT00238667|Drug|Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin)|
16353275|NCT00238641|Drug|Botulinum Toxin type B|
16353276|NCT00238628|Drug|Bexarotene|
16353277|NCT00238628|Drug|Iressa|
16353278|NCT00238615|Drug|Docetaxel|20 mg/m2, 75 mg/m2 infusion
16353279|NCT00238615|Drug|Carboplatin|AUC of 2 and 6 infusion
16353280|NCT00238615|Procedure|Radiation therapy|NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
16353281|NCT00238615|Procedure|Surgical resection|All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
16353282|NCT00238602|Procedure|Stereotactic radiosurgery|
16353283|NCT00238563|Drug|Triamcinolone injection, sub-tenon|
16353284|NCT00238550|Drug|Cannabis based medicine extract (CBME)|
16353285|NCT00238537|Drug|Alteplase t-PA|
16353286|NCT00238524|Drug|SPM 927|
16353287|NCT00238511|Drug|SPM 927|
16353288|NCT00238498|Drug|vildagliptin|
16353289|NCT00238485|Drug|Licarbazepine|
16353290|NCT00238472|Drug|nateglinide|
16353291|NCT00238459|Drug|Patients elected to take licensed drugs. The vaccine was not provided for evaluation|Note:In August 2007 we were notified by the manufacturer that the experimental vaccine was no longer being made and would no longer be available for this study. Too few participants have received the vaccine or placebo to conclude anything about potential efficacy
16353292|NCT00238459|Drug|multiple licensed drugs not randomized|
16353293|NCT00238459|Drug|multiple licensed antiretroviral drugs; not randomized|
16353294|NCT00238459|Other|Intended vaccine not provided, Licensed drugs provided, but were not investigated|
16353295|NCT00238446|Drug|EC-MPS|
16353296|NCT00238433|Biological|filgrastim|5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days.
16353297|NCT00238433|Drug|busulfan|3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
16353298|NCT00238433|Drug|melphalan|50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
16353299|NCT00238433|Drug|thiotepa|250 mg/m2/day/iv on days -3 and -2
16353300|NCT00238433|Procedure|bone marrow ablation with stem cell support|The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
16353301|NCT00238433|Procedure|peripheral blood stem cell transplantation|Performed 36-48 hours following last chemotherapy dose.
16353302|NCT00238420|Drug|Paclitaxel|Given IV
16353303|NCT00238420|Radiation|Radiation Therapy|Undergo radiation therapy
16353304|NCT00238420|Biological|Trastuzumab|Given IV
16353305|NCT00238407|Drug|Docetaxel and Cisplatin|Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.
16353306|NCT00238407|Radiation|Radiotherapy|Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
16353307|NCT00238394|Drug|cediranib maleate|Given orally
16353308|NCT00238394|Other|laboratory biomarker analysis|Correlative studies
16353309|NCT00238381|Procedure|5 cm colon-J-pouch|5 cm colon-J-pouch with/without temporary protective ileostomy
16353310|NCT00238381|Procedure|side-to-end anastomosis|side-to-end anastomosis with/without temporary protective ileostomy
16353311|NCT00238381|Procedure|straight coloanal anastomosis|straight coloanal anastomosis with/without temporary protective ileostomy
16353312|NCT00238368|Biological|filgrastim|
16353313|NCT00238368|Biological|rituximab|
16353314|NCT00238368|Drug|busulfan|
16353315|NCT00238368|Drug|cisplatin|
16353316|NCT00238368|Drug|cyclophosphamide|
16353317|NCT00238368|Drug|cytarabine|
16353318|NCT00238368|Drug|doxorubicin hydrochloride|
16353319|NCT00238368|Drug|etoposide|
16353320|NCT00238368|Drug|methylprednisolone|
16353321|NCT00238368|Drug|prednisone|
16353322|NCT00238368|Drug|vincristine sulfate|
16353323|NCT00238368|Procedure|autologous bone marrow transplantation|
16353324|NCT00238368|Procedure|peripheral blood stem cell transplantation|
16353325|NCT00238368|Procedure|positron emission tomography|
16353326|NCT00238368|Radiation|fludeoxyglucose F 18|
16353327|NCT00238368|Radiation|radiation therapy|
16353406|NCT00237822|Behavioral|AF + Contingency Management (AF + CM)|
16353328|NCT00238355|Drug|caspofungin acetate|70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
16353329|NCT00238355|Drug|voriconazole|6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).
16353330|NCT00238342|Genetic|proteomic profiling|
16353331|NCT00238342|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
16353332|NCT00238342|Procedure|biopsy|
16353333|NCT00238329|Biological|PEG-interferon alfa-2b|
16353334|NCT00238329|Drug|thalidomide|
16353335|NCT00238316|Drug|letrozole|2.5 mg PO daily for 1 year
16353336|NCT00238316|Other|Placebo|2.5 mg PO daily for one 1 year
16353337|NCT00238303|Drug|vorinostat|Given orally
16353338|NCT00238303|Procedure|conventional surgery|Patients undergo surgery to remove tumor
16353339|NCT00238290|Drug|Trastuzumab + Letrozole|Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
16353340|NCT00238277|Drug|temozolomide|
16353341|NCT00238277|Procedure|adjuvant therapy|
16353342|NCT00238277|Procedure|chemotherapy|
16353343|NCT00238277|Procedure|radiation therapy|
16353344|NCT00238264|Radiation|radiation therapy|Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
16353345|NCT00238251|Drug|gefitinib|Once daily during days 1-28
16353346|NCT00238251|Drug|temozolomide|Once daily on days 1-21
16353347|NCT00238251|Radiation|radiation therapy|Whole brain radiotherapy
16353348|NCT00238238|Biological|rituximab|Given IV
16353349|NCT00238238|Drug|lenalidomide|Given orally
16353350|NCT00238225|Dietary Supplement|calcitriol|
16353351|NCT00238225|Drug|dexamethasone|
16353352|NCT00238225|Drug|ketoconazole|
16353353|NCT00238212|Drug|sorafenib tosylate|Given orally
16353354|NCT00238212|Other|laboratory biomarker analysis|Correlative studies
16353355|NCT00238199|Dietary Supplement|calcitriol|
16353356|NCT00238199|Drug|docetaxel|
16353357|NCT00238173|Biological|filgrastim|
16353358|NCT00238173|Drug|acetylcysteine|administered i.v. over 30 to 60 minutes
16353359|NCT00238173|Drug|carboplatin|(200 mg/m2/day; total dose 400 mg/m2) will be infused i.a. over 10 minutes, in 50-180 cc of normal saline.
16353360|NCT00238173|Drug|cyclophosphamide|(330 mg/m2/day; total dose 660 mg/m2) will be infused i.v. in 25-50 cc of normal saline, over approximately 10 minutes.
16353361|NCT00238173|Drug|etoposide phosphate|(200 mg/m2/day; total dose 400 mg/m2) will be infused i.v. in 25-100 cc of normal saline, over approximately 10 minutes, immediately following the cyclophosphamide.
16353362|NCT00238173|Drug|mannitol|(25%) delivered i.a. at a pre-determined flow rate over 30 seconds. The flow rate will be determined by iodinated contrast injection and fluoroscopy as the lowest infusion rate in which there is retrograde flow from the arterial catheter. The rate and volume of mannitol infused will be approximately 4-12 cc/sec x 30 seconds.
16353363|NCT00238173|Drug|sodium thiosulfate|STS is available as a 25% (250 mg/ml) solution. The dose of STS administered 4 hours after carboplatin is 16 gm/m2. The dose of STS administered 8 hours after carboplatin is 16 gm/m2. Actual dose to be administered will be determined and mixed with an equivalent amount of sterile water (1 ml:1 ml) for infusion.
16353364|NCT00238160|Drug|cisplatin|
16353365|NCT00238160|Drug|fluorouracil|
16353366|NCT00238160|Procedure|adjuvant therapy|
16353367|NCT00238160|Procedure|chemotherapy|
16353368|NCT00238160|Procedure|conventional surgery|
16353369|NCT00238160|Procedure|hepatic arterial infusion|
16353370|NCT00238160|Procedure|surgery|
16353371|NCT00238147|Drug|capecitabine|
16353372|NCT00238147|Drug|carboplatin|
16353373|NCT00238147|Drug|docetaxel|
16353374|NCT00238147|Procedure|conventional surgery|
16353375|NCT00238147|Procedure|neoadjuvant therapy|
16353376|NCT00238147|Radiation|radiation therapy|
16353377|NCT00238121|Drug|sorafenib tosylate|Given orally
16353378|NCT00238108|Drug|Melatonin|2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
16353379|NCT00238108|Drug|Placebo|Placebo
16353380|NCT00238082|Drug|HFA-134A Beclomethasone DIpropionate (QVAR)|
16353381|NCT00238069|Device|CPAP machine as a result of sleep study|
16353382|NCT00238056|Drug|domperidone Drug|
16353383|NCT00238043|Drug|Biogeneric Epoetin|
16353384|NCT00238030|Drug|L-thryoxine|2 mcg/kg iv or 2 mcg/kg po at time of enrollment
16353385|NCT00238030|Drug|iv thryoxine|thyroxine 2 mcg/kg iv
16353386|NCT00238017|Drug|amodiaquine-artesunate versus amodiaquine|
16353387|NCT00238004|Drug|Nicotinic acid|
16353388|NCT00237991|Biological|Hepatitis A|
16353389|NCT00237978|Drug|Adapalen|
16353390|NCT00237978|Radiation|VIS and wIRA|
16353391|NCT00237965|Behavioral|Mole Mapping Diagram|
16353392|NCT00237952|Drug|EDTA chelating agents|
16353393|NCT00237939|Drug|Aripiprazole|
16353394|NCT00237926|Behavioral|Exercise|aerobic or resistance training
16353395|NCT00237913|Drug|Aripiprazole|Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
16353396|NCT00237913|Drug|Olanzapine or Quetiapine or Risperidone|Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.
16353397|NCT00237900|Drug|Gefitinib, 5-fluorouracil, leucovorin and radiotherapy|
16353398|NCT00237887|Drug|adalimumab|
16353399|NCT00237874|Drug|Aripiprazole|
16353400|NCT00237861|Drug|risperidone|
16353401|NCT00237861|Drug|olanzapine|
16353402|NCT00237861|Drug|quetiapine|
16353403|NCT00237848|Drug|D-serine|
16353404|NCT00237848|Behavioral|Cognitive retraining|
16353405|NCT00237822|Behavioral|Adherence Feedback (AF)|
16353407|NCT00237822|Behavioral|AF + Motivational Enhancement Therapy (AF + MET)|
16353408|NCT00237809|Drug|D-serine|D-serine (30 mg/kg)
16353409|NCT00237809|Behavioral|Cognitive Retraining (CRT)|Cognitive retraining therapy (CRT)
16353410|NCT00237809|Drug|Placebo|Placebo D-serine Drug
16353411|NCT00237809|Behavioral|Cognitive Retraining Placebo|Cognitive retraining therapy (CRT) control
16353412|NCT00237796|Behavioral|Cognitive Behavioral Social Skills Training (CBSST)|Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
16353413|NCT00237796|Behavioral|Goal Focused Supportive Contact (GFSC)|Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
16353414|NCT00237783|Drug|dialysate sodium (140 mmol/L)|
16353415|NCT00237783|Drug|individualized dialysate sodium|individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
16353416|NCT00237770|Drug|N-Nitro L-arginine-methylester (L-NAME)|A non-specific inhibitor of the nitric oxide synthase enzyme.
16353417|NCT00237770|Procedure|Head-up Tilt maneuver|Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.
16353418|NCT00237757|Behavioral|Information feedback|The experimental arm consisted of a six month staff training period. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing. The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes.
16353419|NCT00237757|Behavioral|Information feedback|The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative.
16353420|NCT00237744|Device|Robotics training for shoulder elbow.|training utilizing a robot to assist with movement practice
16353421|NCT00237744|Device|Surface Functional Neuromuscular Stimulation|training utilizing FNS to assist with movement practice
16353422|NCT00237744|Other|whole arm motor learning|intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
16353423|NCT00237731|Drug|morphine|morphine 0.05
16353424|NCT00237731|Drug|morphine|morphine 0.10
16353425|NCT00237718|Drug|Alpha, gamma, beta, and delta (mixed) tocopherols|approximately 666 IU daily (1 pill) for 6 months
16353426|NCT00237718|Drug|Alpha lipoic acid|600 mg daily (2 pills 300 mg each) for 6 months
16353427|NCT00237718|Drug|Placebo|placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months
16353428|NCT00237718|Drug|Placebo|placebo for alpha lipoic acid; 2 pills daily for 6 months
16353429|NCT00237705|Drug|metoclopramide|
16353430|NCT00237692|Behavioral|Nurse Behavioral intervention with Home BP Telemonitoring|Nurse-administered behavior intervention
16353431|NCT00237692|Behavioral|Nurse Medication Management with Home BP Telemonitoring|Nurse administer medication management according to hypertension decision support
16353432|NCT00237692|Behavioral|Nurse Combined intervention with Home BP Telemonitoring|Combination of the nurse administered tailored behavioral & medication management
16353433|NCT00237679|Behavioral|Neuromuscular Electrical Stimulation|Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
16353434|NCT00237679|Behavioral|Unstimulated|No current is generated.
16353435|NCT00237666|Drug|Ziprasidone|Ziprasidone 20-60 mg BID, taken orally.
16353436|NCT00237653|Drug|Valganciclovir|
16353437|NCT00237640|Drug|Cinnamon or placebo 500 mg capsule twice daily|Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
16353438|NCT00237627|Drug|PS-341|PS-341 will be administered as an intravenous push into a side arm of either a peripheral or central intravenous line infusing normal saline at 100 ml/hr. Patients will be treated twice weekly for two weeks, followed by a one week rest period, such that the typical days of treatment will be days 1, 4, 8, 11 of each three-week cycle. The initial dose level for PS-341 will be 0.9 mg/m2/dose intravenously, while subsequent dose levels will be determined according to a modified Fibonacci schema
16353439|NCT00237627|Drug|Doxil|Doxil will be administered at a dose of 30 mg/m2 as a 1 hour infusion through either a peripheral or central intravenous line every 3 weeks (on day 4 of each 21 day cycle)
16353440|NCT00237627|Drug|Velcade|Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks
16353441|NCT00237614|Drug|intravenous and oral N-acetylcysteine|
16353442|NCT00237601|Other|obstetric care|
16353443|NCT00237588|Drug|Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg|
16353444|NCT00237575|Drug|gemcitabine|
16353445|NCT00237575|Drug|cisplatin|
16353446|NCT00237575|Drug|sargramostim|
16353447|NCT00237575|Drug|filgrastim|
16353448|NCT00237562|Procedure|Large loop electrosurgical excision|
16353449|NCT00237549|Procedure|optimised treatment|"The intervention targeted individual patients and the Primary Care Team. Practitioners were trained in a target driven, intensive multifactorial approach including lifestyle advice (smoking cessation, physical activity 30 min./day and healthy diet) and pharmacological treatment with the aim of reducing the complications of diabetes as described in protocol.
~The training included meetings, practice visiting, written feed back reports and reminders on controls."
16353450|NCT00237536|Drug|Lonidamine|
16353451|NCT00237523|Drug|IoGen (molecular iodine)|
16353453|NCT00237497|Drug|Ramelteon|Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.
16353454|NCT00237497|Drug|Zopiclone|Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.
16353455|NCT00237497|Drug|Placebo|Placebo-matching tablets, orally, once daily for up to 28 nights.
16353456|NCT00237484|Drug|Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin|"Powder for intravenous infusion (100 mg strength), intravenous, single dose of 5 mg/kg, at Day -7, prior to initiation of the following combination therapy:
~powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks"
16353457|NCT00237484|Drug|Combination of (a) pegylated interferon alfa-2b and (b) ribavirin|"Powder for injection in vials or Redipen (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
~200 mg capsules, oral, dose of 800-1400 mg (weight based dosing as per PEGETRON Product Monograph), daily for up to 48 weeks"
16353458|NCT00237471|Drug|Insulin (tight blood glucose control)|
16353459|NCT00237458|Drug|Lacosamide|"Dosage: Lacosamide up to 400 mg/day;
~Dosage form: Film-coated tablets;
~Dosage Frequency and Duration: Two times per day; 9.5 years"
16353460|NCT00237445|Drug|telithromycin|
16353461|NCT00237445|Drug|azithromycin|
16353462|NCT00237419|Drug|infliximab|Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks
16353463|NCT00237406|Procedure|interactive voice response|
16353464|NCT00237393|Drug|Quetiapine|Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
16353465|NCT00237393|Drug|Placebo|Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
16353466|NCT00237380|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water.
16353467|NCT00237367|Drug|rabeprazole and pantoprazole|
16353468|NCT00237354|Drug|PV-10 (rose bengal disodium 10%)|PV-10 ablation of study lesion
16353469|NCT00237341|Drug|fentanyl|
16353470|NCT00237328|Drug|Heparin|Heparin will be used as the intra-operative anticoagulant
16353471|NCT00237302|Drug|topiramate|
16353472|NCT00237289|Drug|topiramate|
16353473|NCT00237276|Procedure|colonoscopy|
16353474|NCT00237263|Drug|Entacapone|
16353475|NCT00237250|Drug|vildagliptin|
16353476|NCT00237237|Drug|vildagliptin|
16353477|NCT00237224|Drug|Letrozole|
16353478|NCT00237211|Drug|Letrozole|
16353479|NCT00237198|Drug|Letrozole|
16353480|NCT00237185|Drug|Imatinib mesylate|Participants were randomized 1:1 to receive imatinib mesylate 400 mg/day or 600 mg/day. Upon unsatisfactory treatment effect on the starting dose of 400 mg/day or 600 mg/day imatinib mesylate, in the opinion of the treating physician, a dose increase up to 600 mg/day or 800 mg/day, was allowed provided that the participant continued to benefit from the treatment and in the absence of safety concerns.
16353481|NCT00237172|Drug|Imatinib Mesylate|once daily
16353482|NCT00237159|Drug|Zoledronic acid|
16353483|NCT00237146|Drug|Zoledronic acid|
16353484|NCT00237133|Drug|Letrozole|1 tablet of Letrozole 2.5 mg orally adminnistered once a day
16353485|NCT00237120|Drug|Imatinib|
16353486|NCT00237107|Procedure|Curretage|
16353487|NCT00237094|Behavioral|Nurse Practitioner led multidisciplinary team approach|
16353488|NCT00237068|Drug|Lansoprazole; Solutab|15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year
16353489|NCT00237042|Behavioral|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
16353490|NCT00237042|Behavioral|Targeted Self Management|Self management as described above. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
16353491|NCT00237042|Drug|20 mcg ethinyl estradiol and 100 mcg levonorgestrel|Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
16353492|NCT00237016|Drug|doxycycline treatment|
16353493|NCT00237003|Behavioral|motivational interviewing|Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
16353494|NCT00236990|Drug|pentosan polysulfate sodium|
16353495|NCT00236977|Drug|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
16353496|NCT00236977|Drug|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
16353497|NCT00236964|Drug|Iron Sucrose + Erythropoietin|
16353498|NCT00236964|Drug|Ferrous Sulfate + Erythropoietin|
16353499|NCT00236951|Drug|iron sucrose injection USP|
16353500|NCT00236951|Drug|stable erythropoietin therapy|
16353501|NCT00236938|Drug|Venofer and stable erythropoietin (EPO) regimen|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
16353502|NCT00236938|Drug|stable erythropoietin (EPO) regimen|Stable erythropoietin (EPO) dose and no supplemental iron.
16353503|NCT00236925|Drug|Low dose Hydrocortisone|Hydrocortisone 10 mg daily
16353504|NCT00236925|Drug|Placebo|Placebo
16353505|NCT00236912|Drug|levofloxacin; metronidazole|
16353506|NCT00236899|Drug|Gemcitabine|"Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
~Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
16353507|NCT00236899|Drug|Docetaxel|"Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
16353508|NCT00236899|Drug|Paclitaxel|"Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
~Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
16353509|NCT00236886|Drug|topiramate|
16353510|NCT00236873|Drug|topiramate|
16353511|NCT00236860|Drug|topiramate|
16353512|NCT00236847|Drug|topiramate|
16353513|NCT00236834|Drug|levofloxacin; imipenem/cilastitin|
16353514|NCT00236821|Drug|levofloxacin|
16353515|NCT00236808|Drug|levofloxacin|
16353516|NCT00236795|Drug|norelgestromin + ethinyl estradiol; triphasil.|
16353517|NCT00236782|Drug|norelgestromin + ethinyl estradiol; mercilon|
16353518|NCT00236769|Drug|norelgestromin + ethinyl estradiol|
16353519|NCT00236756|Drug|topiramate|
16353520|NCT00236743|Drug|topiramate|
16353521|NCT00236730|Drug|topiramate|
16353522|NCT00236717|Drug|Topiramate; Carbamazepine; Valproate|
16353523|NCT00236704|Drug|topiramate|
16353524|NCT00236691|Drug|topiramate|
16353525|NCT00236678|Drug|Epoetin alfa|
16353526|NCT00236665|Drug|topiramate|
16353527|NCT00236652|Drug|levofloxacin|
16353528|NCT00236639|Drug|topiramate|
16353529|NCT00236626|Drug|topiramate|
16353530|NCT00236613|Drug|topiramate|
16353531|NCT00236600|Drug|topiramate|
16353532|NCT00236587|Drug|risperidone|
16353533|NCT00236574|Drug|Galantamine hydrobromide|
16353534|NCT00236561|Drug|topiramate, propranolol|
16353535|NCT00236548|Drug|risperidone|
16353536|NCT00236535|Drug|tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo|
16353537|NCT00236522|Drug|levofloxacin|
16353538|NCT00236509|Drug|topiramate|
16353539|NCT00236496|Drug|topiramate|
16353540|NCT00236483|Drug|tramadol hydrochloride + acetaminophen|
16353541|NCT00236470|Drug|risperidone|
16353542|NCT00236457|Drug|risperidone|
16353543|NCT00236444|Drug|risperidone|
16353544|NCT00236431|Drug|Galantamine hydrobromide|
16353545|NCT00236418|Drug|topiramate|
16353546|NCT00236405|Drug|epoetin alfa|
16353547|NCT00236392|Drug|rabeprazole|
16353548|NCT00236379|Drug|Olanzapine|Target oral dose of 20 milligrams per day for 6 months
16353549|NCT00236379|Drug|Risperidone|Target oral dose of 6 milligrams per day for for 6 months
16353550|NCT00236366|Drug|fentanyl|
16353551|NCT00236353|Drug|risperidone|
16353552|NCT00236340|Device|syringe aspiration|
16353553|NCT00236340|Device|Wall suction|
16353554|NCT00236327|Drug|fentanyl|
16353555|NCT00236301|Drug|CLIMASTON (drug)|CLIMASTON(drug)
16353556|NCT00236301|Drug|17 Beta-estradiol (2mg/day)and (1mg/day)|17 Beta-estradiol (2mg/day)and (1mg/day)
16353557|NCT00236301|Drug|placebo|placebo
16353558|NCT00236288|Drug|Bupropion and intensive behavioral therapy|To prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation.
16353559|NCT00236275|Drug|Fluoro-L-thymidine-(18F)|Fluoro-L-thymidine-(18F)
16353560|NCT00236262|Device|ventilatory strategies with pressure|
16353561|NCT00236249|Drug|Lidocaine|
16353562|NCT00236236|Device|Cardiac Resynchronization Therapy|
16353563|NCT00236223|Drug|Gabapentin + dexamethasone + ketamine|Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
16353564|NCT00236223|Drug|Placebo|Matching placebo
16353565|NCT00236210|Behavioral|Action Score|Improvement in a novel 100-point score summarizing cardiovascular risk.
16353566|NCT00236210|Behavioral|VIP program|Risk assessment, lifestyle counselling, exercise program
16353567|NCT00236197|Drug|rabeprazole sodium|Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
16353568|NCT00236197|Drug|placebo|Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
16353569|NCT00236184|Drug|rabeprazole sodium|Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
16353570|NCT00236184|Other|Placebo|Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
16353571|NCT00236171|Drug|Protopic, Advantan|
16353572|NCT00236171|Procedure|Blood and Urine Test|
16353573|NCT00236171|Procedure|coherence tomography|
16362147|NCT00158405|Drug|Efavirenz (EFV)|
16353574|NCT00236158|Device|AAIR/DDDR pacemaker|Pacemaker with single lead or dual lead
16353575|NCT00236145|Drug|ACTIQ (Oral transmucosal fentanyl citrate)|
16353576|NCT00236119|Drug|CEP-701 20mg|Dosages of oral CEP-701 20mg will be given twice daily. Escalation to the next higher dosage, CEP-701 40mg, may occur once the first 8 patients at the current dosage have completed 8 weeks of treatment without adverse events or laboratory abnormalities. Patients who remain in Cohort 1 will continue on the 20mg dosage until study completion.
16353577|NCT00236119|Drug|CEP-701 40mg|Dosages of oral CEP-701 40mg will be given twice daily.Escalation to the next higher dosage, CEP-701 60mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 2 will continue on the 40mg dosage until study completion.
16353578|NCT00236119|Drug|CEP-701 60mg|Dosages of oral CEP-701 60mg will be given twice daily. Escalation to the next higher dosage, CEP-701 80mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 3 will continue on the 60mg dosage until study completion.
16353579|NCT00236119|Drug|CEP-701 80mg|Dosages of oral CEP-701 80mg will be given twice daily. Patients who have moved to Cohort 4 will continue on the 80mg dosage until study completion.
16353580|NCT00236106|Drug|tacrolimus ointment 0.1%|
16353581|NCT00236106|Drug|mometasone furoate 0.1%|
16353582|NCT00236093|Drug|ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])|
16353583|NCT00236080|Drug|PROVIGIL 200 mg|PROVIGIL 200 mg/day
16353584|NCT00236080|Drug|Armodafinil 250 mg|Armodafinil 250 mg/day
16353585|NCT00236080|Drug|Armodafinil 200 mg|Armodafinil 200 mg/day
16353586|NCT00236080|Drug|Armodafinil 150 mg|Armodafinil 150 mg/day
16353587|NCT00236080|Drug|Placebo|Matching placebo tablets
16353588|NCT00236067|Drug|Gabitril|
16353589|NCT00236054|Drug|Gabitril|
16353590|NCT00236041|Drug|ACTIQ®|
16353591|NCT00236028|Drug|Infliximab|
16353592|NCT00236015|Drug|Gabitril|
16353593|NCT00236002|Drug|Alendronate|Alendronate 70mgm once a week for one year
16353594|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|250 mcg administered s.c.(subcutaneous) every other day
16353595|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|250 mcg administered s.c. every other day (for patients having received 500 mcg before)
16353596|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|500 mcg administered s.c. every other day
16353597|NCT00235989|Drug|Interferon beta 1b (Betaseron, BAY86-5046)|500 mcg administered s.c. every other day (for patients having received 250 mcg before)
16353598|NCT00235976|Drug|Gantacurium Chloride for Injection (AV430A)|
16353599|NCT00235963|Drug|Simvastatin|
16353600|NCT00235950|Drug|Rosuvastatin or atorvastatin or simvastatin and clopidogrel|
16353601|NCT00235937|Drug|Anastrozole and goserelin|
16353602|NCT00235924|Drug|soy isoflavone|
16353603|NCT00235911|Drug|budesonide/formoterol Turbuhaler|
16353604|NCT00235898|Drug|CoFactor|
16353605|NCT00235898|Drug|5-FU|
16353606|NCT00235898|Drug|Leucovorin|
16353607|NCT00235885|Drug|adalimumab|
16353608|NCT00235872|Biological|adalimumab|40 mg eow, sc
16353609|NCT00235859|Drug|adalimumab|
16353610|NCT00235859|Drug|methotrexate|
16353611|NCT00235846|Procedure|vein harvest|Conventional open vein harvest or endoscopic vein harvest
16353612|NCT00235833|Biological|adalimumab|40 mg every other week (eow), subcutaneous (sc)
16353613|NCT00235820|Drug|adalimumab|40 mg every other week following an 80 mg dose
16353614|NCT00235820|Drug|MTX|MTX 7.5 to 25 mg once weekly
16353615|NCT00235820|Drug|placebo adalimumab, placebo MTX|placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
16353616|NCT00235807|Procedure|Tinnitus Masking|Sound therapy with Tinnitus Masking is intended to produce immediate relief from the discomfort caused by tinnitus (Vernon, 1977; 1987; Vernon, 1988). If maskers or combination units are used, the masking sound can be set at any level the patient chooses to attain maximum relief. Relief using masking noise can be accomplished using the external sound of the masker, which is generally a more acceptable sound than the tinnitus.
16353617|NCT00235807|Procedure|Tinnitus Retraining Therapy (TRT)|The TRT procedure adheres as closely as possible to the methodology described by Dr. Pawel Jastreboff. For TRT, sound therapy is used to facilitate long-term habituation to tinnitus (Jastreboff, 1999b).
16353618|NCT00235807|Procedure|Tinnitus Education (TED)|TED represents tinnitus treatment that would typically be provided by audiologists using hearing aids and counseling (although for this study the counseling has been structured and expanded to be equivalent in length to the other two groups).
16353619|NCT00235794|Drug|temsirolimus|
16353620|NCT00235781|Drug|Thymoglobulin|
16353621|NCT00235755|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.
16353622|NCT00235755|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.
16353623|NCT00235755|Drug|Placebo|Oral tablet.
16353624|NCT00235729|Drug|Lofexidine|Lofexidine is an alpha2-adrenergic-agonist with mild to moderate antihypertensive actions. It is mainly used in the alleviation of opioid withdrawal signs and symptoms.
16353625|NCT00235729|Drug|Placebo|Placebo is an exact match of lofexidine, less the active ingredient.
16353626|NCT00235716|Drug|dl-alpha-tocopherol|"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."
16353677|NCT00235235|Procedure|Serum Collection|serum collection
16353678|NCT00235235|Procedure|Urine Collection|urine collection
16353679|NCT00235235|Drug|Doxorubicin|Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
16353680|NCT00235235|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
16353627|NCT00235716|Drug|Memantine|A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
16353628|NCT00235716|Drug|dl-alpha-tocopherol|"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."
16353629|NCT00235716|Drug|Memantine|A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.
16353630|NCT00235716|Drug|Placebo|Matching placebos for dl-alpha-tocopherol and memantine.
16353631|NCT00235703|Device|Antimicrobial Prescribing Decision Support|
16353632|NCT00235690|Procedure|Blood draws|PK samples obtained around a clinical dosing of colistin
16353633|NCT00235690|Other|Blood draw|PK blood samples will be obtained around a clinical dosing of colistin
16353634|NCT00235677|Procedure|Endoscopic gastroplication|
16353635|NCT00235664|Procedure|Collection of stool and endotracheal aspirate samples|collection of samples
16353636|NCT00235651|Drug|Amphotericin B|
16353637|NCT00235625|Drug|Curcuminoids C3 Complex®|
16353638|NCT00235599|Procedure|IGFBP-3 Stimulation Test|
16353639|NCT00235586|Procedure|10 vit. D deficient subjects take vit. D for 3 months.|
16353640|NCT00235573|Dietary Supplement|Vitamin B12|After taking a fasting blood sample, all subjects were given a light breakfast plus 9 micrograms of vitamin B12. Two more doses of vitamin B12, 9 micrograms each, were administered 6 hours apart.
16353641|NCT00235560|Drug|rapamycin|sirolimus
16353642|NCT00235547|Behavioral|timing of initiation of transdermal patch after an abortion|the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic
16353643|NCT00235534|Behavioral|Immediate initiation of OCPs|
16353644|NCT00235534|Behavioral|Delayed initiation of OCPs|
16353645|NCT00235521|Drug|aerosolized iloprost|
16353646|NCT00235508|Drug|Eszopiclone (Lunesta)|Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
16353647|NCT00235495|Biological|Albumin|human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
16353648|NCT00235495|Drug|Saline|equivalent volume of isotonic saline control
16353649|NCT00235482|Drug|Coxsackievirus A21|
16353650|NCT00235469|Drug|SPM 927|
16353651|NCT00235456|Procedure|Perioperative supplemental oxygen|Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
16353652|NCT00235456|Procedure|Standard oxygen|Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
16353653|NCT00235443|Drug|lacosamide|Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
16353654|NCT00235417|Procedure|Bone marrow transplantation|
16353655|NCT00235404|Other|Multicomponent treatment|Specialized care in preparing recharge to home
16353656|NCT00235404|Other|usual care|Usual recharge directly from hospital to home
16353657|NCT00235391|Drug|Deferasirox|125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.
16353658|NCT00235365|Behavioral|meta-cognitive therapy|Meta-cognitive therapy
16353659|NCT00235365|Other|waiting list|waiting list control
16353660|NCT00235352|Drug|CX516 (Ampakine)|
16353661|NCT00235339|Behavioral|Exercise training|Standard exercise training at the hospital, two times per week for twelve weeks
16353662|NCT00235339|Behavioral|Exercise training|Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks
16353663|NCT00235313|Procedure|Dose adjustment of nicotine replacement therapies|Dose adjustment of nicotine replacement therapies
16353664|NCT00235313|Drug|nicotine patch|normal following with a nicotine patch
16353665|NCT00235300|Biological|Thymoglobulin [Anti-thymocyte Globulin (rabbit)]|1.5 mg/kg per day, for a maximum of 5 doses
16353666|NCT00235300|Drug|Simulect (basliximab)|20 mg per day on 2 days
16353667|NCT00235287|Drug|Candesartan and enalapril|24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.
16353668|NCT00235287|Drug|candesartan and enalapril|24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.
16353669|NCT00235287|Drug|candesartan and enalapril|8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg.
16353670|NCT00235287|Drug|candesartan and enalapril|8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)
16353671|NCT00235274|Drug|Subcutaneous Secretin|
16353672|NCT00235261|Drug|Pregabalin|
16353673|NCT00235261|Drug|Dexamethasone|
16353674|NCT00235248|Drug|Warfarin|Warfarin
16353675|NCT00235248|Drug|Clopidogrel-aspirin|Clopidogrel-aspirin
16353676|NCT00235235|Procedure|Biopsy|core biopsy
16353681|NCT00235235|Drug|Capecitabine|Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
16353682|NCT00235235|Drug|Vinorelbine|Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
16353683|NCT00235235|Drug|Gemcitabine|Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
16353684|NCT00235222|Drug|stavudine|
16353685|NCT00235209|Device|Collagen ORC Antimicrobial Matrix (CAM)|
16353686|NCT00235196|Device|Collagen ORC Antimicrobial Matrix (CAM)|
16353687|NCT00235183|Other|plasma|transfusion of more than 15 mL/Kg of plasma
16353688|NCT00235170|Device|drug-eluting stent|Cypher Sirolimus-eluting Coronary stent
16353689|NCT00235157|Device|Sirolimus-eluting Palmaz Genesis peripheral stent|treatment of renal artery stenosis with a renal stent
16353690|NCT00235144|Device|sirolimus-coated Bx Velocity stent|drug-eluting stent
16353691|NCT00235144|Device|uncoated Bx Velocity stent|bare-metal stent
16353692|NCT00235131|Device|Smart Stent|Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
16353693|NCT00235131|Device|Luminexx Stent|Bard® Luminexx™ 6F Vascular Stent
16353694|NCT00235118|Device|Cordis AAA Bilateral Device|
16353695|NCT00235105|Drug|Adalimumab 40 mg sc every other week|
16353696|NCT00235092|Device|Cypher Sirolimus-Eluting Stent|
16353697|NCT00235092|Device|Taxus Paclitaxel-Eluting Stent|
16353698|NCT00235079|Drug|Colchicine|Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
16353699|NCT00235079|Drug|Placebo|Placebo comparator
16353700|NCT00235066|Device|PCI|PCI with Cypher Sirolimus-Eluting Stent
16353701|NCT00235053|Drug|fluticasone/salmeterol DISKUS 250/50|
16353702|NCT00235040|Behavioral|Smart Form|Computer Decision Support System
16353703|NCT00235027|Other|Adverse Drug Event Monitoring|The intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety.
16353704|NCT00235014|Drug|trandolapril|2 mg QD
16353705|NCT00235014|Drug|trandolapril/verapamil|180/2 mg QD
16353706|NCT00235014|Drug|placebo|1 tablet QD
16353707|NCT00235014|Drug|verapamil|SR 240 mg QD
16353708|NCT00235001|Drug|trandolapril/verapamil|180/2 mg QD
16353709|NCT00234988|Drug|sibutramine hydochloride monohydrate|10 mg QD with the option to increase dose to 15 mg QD up until Week 4
16353710|NCT00234975|Drug|Lopinavir/Ritonavir|400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
16353711|NCT00234962|Drug|Lopinavir/Ritonavir|
16353712|NCT00234949|Drug|cefdinir|
16353713|NCT00234949|Drug|cephalexin|
16353714|NCT00234936|Drug|Adalimumab|
16353715|NCT00234936|Drug|Methotrexate|
16353716|NCT00234923|Drug|lopinavir/ritonavir|400 mg lopinavir/ 100 mg ritonavir, BID
16353717|NCT00234923|Drug|lamivudine/zidovudine|300mg lamivudine/150mg zidovudine, BID
16353718|NCT00234910|Drug|Tenofovir DF|TDF 300mg QD for 72 wks
16353719|NCT00234910|Drug|lopinavir/ritonavir with 2 Nucleoside RTIs|LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
16353720|NCT00234897|Drug|adalimumab|
16353721|NCT00234884|Biological|adalimumab|commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
16353722|NCT00234871|Drug|trandolapril/verapamil|2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
16353723|NCT00234871|Drug|Lotrel (amlodipine/benazepril)|5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
16353724|NCT00234858|Drug|trandolapril/verapamil|2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
16353725|NCT00234858|Drug|(Hyzaar) losartan/hydrochlorothiazide|50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
16353726|NCT00234845|Drug|adalimumab|
16353727|NCT00234845|Drug|methotrexate|
16353728|NCT00234832|Drug|Sibutramine hydrochloride|One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
16353729|NCT00234832|Drug|Placebo|1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
16353730|NCT00234832|Drug|Sibutramine hydrochloride|10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
16353731|NCT00234819|Drug|Bazedoxifene/Conjugated Estrogen|
16353732|NCT00234806|Other|Health-e-Access|telemedicine intervention
16353733|NCT00234793|Behavioral|Problem-Solving Skills Training|
16353734|NCT00234780|Procedure|pediatric nursing used in home to avoid hospitalization|
16353735|NCT00234767|Device|Pulmonary Artery Catheter|
16353736|NCT00234767|Behavioral|Protocolized Fluid Management|
16353737|NCT00234754|Procedure|TVT Surgery TOT Surgery|TVT surgery and TOT surgery
16353738|NCT00234741|Drug|STA-5326 mesylate|
16353739|NCT00234728|Device|Occlusive dressing|
16353740|NCT00234702|Drug|Lanthanum carbonate|Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.
16353741|NCT00234702|Drug|Placebo|Placebo
16353742|NCT00234689|Drug|Naltrexone|
16353743|NCT00234676|Drug|Premarin ®|Premarin ® 0.625 mg per day orally
16353744|NCT00234663|Drug|PTC124|
16353745|NCT00234650|Procedure|Colonoscopy|
16353746|NCT00234637|Drug|Rivastigmine, memantine|
16353747|NCT00234611|Procedure|Echocardiogram guided left ventricular lead placement|
16353748|NCT00234598|Procedure|Toothbrushing only|Toothbrushing three times per 24 hours without chlorhexidine
16353749|NCT00234598|Procedure|Chlorhexidine only|Chlorhexidine oral rinse twice per 24 hours without toothbrushing
16353750|NCT00234598|Procedure|Toothbrushing and Chlorhexidine|Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.
16353751|NCT00234585|Device|Renal Artery Stent with Protective Device/Drug|
16353752|NCT00234572|Drug|Lanreotide (Autogel formulation)|
16353753|NCT00234559|Device|VAC® Therapy System|
16353754|NCT00234546|Biological|Botulinum toxin type A|1 injection, 500 U at day 0. The study will last for 6 months in each patient.
16353755|NCT00234546|Drug|Placebo|1 injection at day 0. The study will last for 6 months in each patient.
16353756|NCT00234533|Drug|Somatropin (rDNA origin)|Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
16353757|NCT00234507|Biological|Botulinum toxin type A|
16353758|NCT00234494|Drug|Cisplatin|Cisplatin 70 mg/m2, day 1
16353759|NCT00234494|Drug|Gemcitabine|Gemcitabine 1250 mg/m2, day 1 and 8
16353760|NCT00234494|Drug|Bevacizumab|Bevacizumab 15mg/kg, day 1
16353761|NCT00234481|Drug|XL844|
16353762|NCT00234468|Drug|Iressa (Gefitinib)|
16353763|NCT00234455|Device|drug eluting-stent|PCI
16353764|NCT00234455|Device|drug-eluting stent|PCI
16353765|NCT00234442|Drug|Iressa (Gefitinib)|
16353766|NCT00234429|Drug|Gefitinib, raltitrexed|
16353767|NCT00234416|Drug|Gefitinib|
16353768|NCT00234416|Drug|Gemcitabine|
16353769|NCT00234403|Drug|gefitinib and fulvestrant|
16353770|NCT00234390|Drug|Pulmicort (budesonide) pMDI|
16353771|NCT00234377|Drug|Seroquel SR|
16353772|NCT00234312|Drug|escitalopram and sertraline|
16353773|NCT00234299|Drug|Aspirin|325mg, one tablet orally, six months
16353774|NCT00234299|Drug|Placebo|325mg, one tablet orally every day, 6 months
16353775|NCT00234286|Behavioral|Comfort care education intervention|Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
16353776|NCT00234273|Procedure|Rehabilitation programme in Adapted Physical Activity (APA)|
16353777|NCT00234273|Behavioral|Therapeutic education primarily focused on dietary|
16353778|NCT00234247|Other|Long Term Follow-Up|Extended and enhance the follow-up of the NHLBI iNO RCT by assessing the effects of iNO use on: 1.) long term clinical and childhood developmental outcomes; 2.) family impact, and; 3.) healthcare costs of prematurity-associated respiratory failure.
16353779|NCT00234234|Drug|Adalimumab|
16353780|NCT00234221|Behavioral|Strengths Based Case Management|
16353781|NCT00234221|Behavioral|Motivational Enhancement Therapy|
16353782|NCT00234221|Behavioral|Brief Informational Feedback|
16353783|NCT00234208|Procedure|Medical thoracoscopy|
16353784|NCT00234208|Procedure|Simple chest tube drainage|
16353785|NCT00234195|Drug|bupropion extended release (Wellbutrin XL)|
16353786|NCT00234182|Drug|Interferon alpha-2b|
16353787|NCT00234169|Drug|VTP195183|"VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
~Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first."
16353788|NCT00234156|Procedure|oral fructose and high fat diet|"High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.
~Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours."
16353789|NCT00234143|Behavioral|Darbepoetin and Filgrastim|Aranesp and Neupogen G-CSF (Neupogen) 300 mcg s.c. twice a week, 3-4 days apart and EPO (Aranesp) 500 mcg s.c. once every 2 weeks until week 24, titrate depending of response
16353790|NCT00234143|Drug|Darbepoetin|Aranesp EPO (Aranesp) 500 mcg s.c. once every 2 weeks until 24 weeks, titrate depending of response
16353791|NCT00234130|Procedure|nocturnal vs conventional dialysis|
16353792|NCT00234117|Drug|Rabeprazole|
16353793|NCT00234104|Drug|OPC-41061(Tolvaptan)|
16353794|NCT00234091|Drug|Abacavir|8 mg/kg (up to 300 mg/dose) take orally twice daily
16353795|NCT00234091|Drug|Efavirenz|200 to 600 mg taken orally once daily
16353796|NCT00234091|Drug|Lamivudine|4 mg/kg (up to 150 mg/dose) taken orally twice daily
16353797|NCT00234091|Drug|Lopinavir/Ritonavir|230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food
16353798|NCT00234091|Drug|Nelfinavir|45-55 mg/kg taken orally twice daily with food
16353799|NCT00234091|Drug|Nevirapine|120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily
16353800|NCT00234091|Drug|Zidovudine|180-240 mg/m^2 every 12 hours (up to 300 mg/dose)
16353801|NCT00234078|Drug|0.5% OPC-12759|
16353802|NCT00234078|Drug|1% OPC-12759|
16353803|NCT00234078|Drug|2% OPC-12759|
16353804|NCT00234078|Drug|placebo|
16353805|NCT00234065|Drug|Cilostazol|oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
16353806|NCT00234065|Drug|Aspirin|oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
16353807|NCT00234052|Biological|bevacizumab|5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
16353808|NCT00234052|Drug|carboplatin|Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
16353809|NCT00234052|Drug|pemetrexed|Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
16353810|NCT00234039|Drug|gemcitabine hydrochloride|
16353811|NCT00234026|Drug|gemcitabine hydrochloride|
16353812|NCT00234000|Drug|arsenic trioxide|Each 28-day treatment cycle will include dosing for 2 days per week of ATO. Subjects will recieve 1 mg/mL each dosing day.
16353813|NCT00234000|Drug|azacitidine|Each 28-day treatment cycle will include dosing the first five days of cycle with Azacitidine. Cohorts of three to six patients will each receive 25, 50, and 75 mg/m2/d injected subcutaneously.
16353814|NCT00233987|Drug|carmustine|150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
16353815|NCT00233987|Drug|cyclophosphamide|100 mg/kg IV 2 days before transplant.
16353816|NCT00233987|Drug|etoposide|60 mg/kg IV over 4 hours 4 days before transplant.
16353817|NCT00233987|Drug|melphalan|150 mg/m^2 IV 1 day before transplant.
16353818|NCT00233987|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.
16353819|NCT00233987|Radiation|radiation therapy|150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
16353820|NCT00233974|Procedure|PET (positron emission tomography)|Following conventional segmental mastectomy with or without needle localization, the patient will then undergo intraoperative PET-probe evaluation
16353821|NCT00233961|Biological|filgrastim|
16353822|NCT00233948|Drug|nelfinavir mesylate|Given orally
16353823|NCT00233948|Procedure|biopsy|Correlative studies
16353824|NCT00233948|Other|laboratory biomarker analysis|Correlative studies
16353825|NCT00233948|Other|pharmacological study|Correlative studies
16353826|NCT00233948|Genetic|gene expression analysis|Correlative studies
16353827|NCT00233948|Genetic|western blotting|Correlative studies
16353828|NCT00233948|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16353829|NCT00233948|Other|immunoenzyme technique|Correlative studies
16353830|NCT00233935|Other|placebo|Given PO
16353831|NCT00233935|Drug|defined green tea catechin extract|Given PO
16353832|NCT00233922|Device|Osteosheet(r)|
16353833|NCT00233909|Drug|Zosuquidar|
16353834|NCT00233909|Drug|gemtuzumab ozogamicin|
16353835|NCT00233896|Drug|Oral beclomethasone dipropionate (drug)|
16353836|NCT00233883|Drug|enfuvirtide [Fuzeon]|90mg sc bid by Biojector 2000 NFID for 4 weeks
16353837|NCT00233883|Drug|enfuvirtide [Fuzeon]|"90mg sc bid by 27G1/2 needle/syringe for 4 weeks"
16353838|NCT00233870|Drug|Agalsidase beta (recombinant form)|agalsidase beta 1.0 mg/kg body weight infused every 2 weeks as an intravenous infusion
16353839|NCT00233857|Procedure|Auricular acupuncture|
16353840|NCT00233844|Procedure|"Venipuncture with cough-trick"|
16353841|NCT00233831|Device|Generator of electromagnetic millimeter waves|
16353842|NCT00233818|Device|Sirolimus-coated Bx VELOCITY Stent|
16353843|NCT00233805|Device|Sirolimus coated Bx Velocity™|drug-eluting stent
16353844|NCT00233805|Device|Bare metal Bx Velocity™|bare-metal stent
16353845|NCT00233792|Device|sirolimus coated Bx VELOCITY stent - fast release|
16353846|NCT00233792|Device|sirolimus coated Bx VELOCITY stent - slow release|
16353847|NCT00233779|Device|SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT|
16353848|NCT00233766|Device|Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose|
16353849|NCT00233753|Device|Cordis Neurovascular Self-Expanding Stent|
16353850|NCT00233740|Device|OPTEASE Vena Cava Filter|
16353851|NCT00233727|Procedure|HPV DNA Testing + Cryosurgery|"Patients will undergo a Screen and Treat program utilizing HPV DNA testing of clinician-collected cervical samples, followed by cryosurgery of screen positive women."
16353852|NCT00233727|Procedure|VIA + Cryosurgery|"Patients will undergo a Screen and Treat program utilizing visual inspection of the cervix with acetic acid (VIA), followed by cryosurgery of screen positive women."
16353853|NCT00233714|Device|CYPHER Sirolimus-Eluting Coronary Stent|Single dose Sirolimus-Eluting coronary stent
16353854|NCT00233714|Device|CYPHER Sirolimus-Eluting Coronary Stent|Double-dose Sirolimus-Eluting coronary stent
16353855|NCT00233688|Device|QUANTUM LP™ STENT GRAFT SYSTEM|Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
16353856|NCT00233688|Procedure|Open surgical repair|Open surgical repair
16353857|NCT00233675|Drug|GABITRIL (tiagabine hydrochloride; CEP-6671)|
16353858|NCT00233662|Drug|Alefacept|
16353859|NCT00233636|Drug|Iressa (Gefitinib)|
16353860|NCT00233636|Procedure|Radiotherapy|
16353861|NCT00233623|Drug|Iressa (Gefitinib)|
16353862|NCT00233623|Drug|Irinotecan|
16353863|NCT00233623|Drug|5Fluorouracil|
16353864|NCT00233623|Drug|Leucovorin|
16353865|NCT00233610|Drug|Bicalutamide|
16353866|NCT00233610|Drug|Tamoxifen|
16353867|NCT00233597|Drug|ferumoxytol or oral iron|
16353868|NCT00233584|Procedure|Pulmicort (budesonide) pMDI|
16353869|NCT00233571|Biological|Adalimumab 40 mg subcutaneous (SC) every other week (EOW)|
16353870|NCT00233558|Drug|adalimumab (up to 9 months exposure)|
16353871|NCT00233558|Drug|methotrexate|
16353872|NCT00233545|Drug|miltefosine|
16353873|NCT00233545|Drug|antimony|
16353874|NCT00233532|Drug|Trandolapril|0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
16353875|NCT00233519|Drug|SomatoKine/IPLEX|"Cohort 1: self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
~Cohort 2: consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection."
16353876|NCT00233506|Drug|CpG 7909|
16353877|NCT00233480|Drug|atorvastatin|atorvastatin 10mg PO QD
16353878|NCT00233480|Drug|placebo|matched placebo Qd x 3 months
16353879|NCT00233454|Drug|Midostaurin|Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR
16353880|NCT00233441|Drug|CELIVARONE (SSR149744C)|
16353881|NCT00233428|Procedure|Blood Draw|
16353882|NCT00233415|Device|Stereotactic Radiosurgery (Cyberknife)|
16353883|NCT00233402|Drug|Hexvix|Single Instillation, Transurethral Resection of the Bladder
16353884|NCT00233402|Procedure|Standard white light cystoscopy|
16353885|NCT00233389|Drug|Rebamipide|
16353886|NCT00233376|Procedure|Access to an antibiotic decision support system|
16353887|NCT00233376|Behavioral|Distribution of local antibiotic guidelines|
16353888|NCT00233363|Drug|Rebamipide|
16353889|NCT00233350|Device|use of navigated 3D ultrasound during surgery|
16353890|NCT00233337|Drug|Co-artemether|
16353891|NCT00233324|Drug|Surfactant|Intubation and administration of surfactant by 1 hour of age.
16353892|NCT00233324|Device|Continuous Positive Airway Pressure (CPAP)|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
16353893|NCT00233324|Drug|Supplemental oxygen with target saturation of 85 to 89%|Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
16353894|NCT00233324|Drug|Supplemental oxygen with target saturation of 91 to 95%|Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
16353895|NCT00233259|Behavioral|Mediterranean Diet|Mediterranean dietary program
16353896|NCT00233259|Behavioral|Physical Activity|Physical activity program
16353897|NCT00233259|Behavioral|Stress Management|Stress management program
16353898|NCT00233259|Behavioral|Social Support|Social support
16353899|NCT00233259|Behavioral|Smoking Cessation|Smoking cessation program
16353900|NCT00233259|Other|Control group|Usual Diabetes Care Control group
16353901|NCT00233246|Procedure|FFP Infusion|
16353902|NCT00233233|Behavioral|Standardized Asthma Education Program|
16353903|NCT00233220|Behavioral|Multicomponent, multi-level intervention targeted at physicians and patients|The patient intervention will include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial.
16353904|NCT00233220|Behavioral|Usual Care|Patients will receive usual care.
16353905|NCT00233207|Drug|IC14|
16353906|NCT00233194|Procedure|Observational follow-up study of adenotonsillectomy|Studies of sleep, behavior, cognition, and daytime sleepiness
16353907|NCT00233181|Behavioral|Home-based adherence monitoring|
16353908|NCT00233168|Behavioral|Adherence Program|14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
16353909|NCT00233168|Behavioral|Life Skills and Self-Esteem Training Program (Attention Control Arm)|Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month.
16353910|NCT00233155|Drug|Capsaicin Dermal Patch|
16353911|NCT00233142|Behavioral|Expressive writing|Writing as therapeutic intervention
16353912|NCT00233142|Behavioral|Neutral writing|Non-expressive writing
16353913|NCT00233129|Behavioral|Top Down|Six months
16353914|NCT00233129|Other|cognitive rehabilitation day treatment program|six months
16353915|NCT00233103|Drug|Sertraline|Sertraline arm
16353916|NCT00233103|Drug|Placebo|Placebo
16353917|NCT00233090|Drug|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
16353918|NCT00233090|Drug|Placebo|daily dose of placebo for four weeks.
16353919|NCT00233077|Behavioral|Patient Assistance|Patients will be surveyed to assess their knowledge about cancer & its treatment, experience with & access to health care system, trust, depression, social support & self-efficacy. A Brief Screening Needs Assessment will be done to ascertain practical, informational or psychosocial needs; based on their responses, an individualized action plan to connect with patient assistance programs will be created for the intervention group. We will ask intervention patients if they connected with any programs in their action plan. For those who didn't connect, we will give their name to an outreach worker. The outreach worker will call patients and identify reasons for not contacting the assistance programs.
16353920|NCT00233077|Behavioral|Information only|Control patients will be sent a pamphlet about breast cancer & its treatment. We will call all patients 2 weeks later and ask if they received the packet. If they didn't, we will send the packet again.
16353921|NCT00233064|Biological|Lyophilized Palivizumab|Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
16353922|NCT00233064|Biological|Liquid Palivizumab|Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
16353923|NCT00233051|Drug|Salmeterol or Salmeterol/Fluticasone|
16353924|NCT00233038|Procedure|Ethanol injection into a cyst|
16353925|NCT00233025|Drug|Duloxetine|
16353926|NCT00233025|Drug|Placebo|
16353927|NCT00233012|Drug|Topiramate|
16353928|NCT00232999|Drug|Nebulized IVX-0142|
16353929|NCT00232973|Drug|ICXP007|
16353930|NCT00232960|Procedure|Radiotherapy 50 Gy|
16353931|NCT00232947|Biological|Influenza virus vaccine (Fluviral)|
16353932|NCT00232947|Biological|Influenza virus vaccine (Fluzone)|
16353933|NCT00232934|Drug|Thalidomide|
16353934|NCT00232921|Drug|caudal volume 1|
16353935|NCT00232921|Biological|caudal volume 2|
16353936|NCT00232921|Drug|caudal volume 3|
16353937|NCT00232908|Drug|ARV regimen|As prescribed
16353938|NCT00232908|Drug|enfuvirtide [Fuzeon]|90mg sc bid for 12 weeks
16353939|NCT00232895|Drug|lipuro propofol|
16353940|NCT00232895|Drug|standard formulation propofol|
16353941|NCT00232882|Drug|Candesartan Thiazide|Candesartan 16 mg for 4 weeks then added hydrochlorothiazide for 4 weeks
16353942|NCT00232882|Drug|Atenolol Thiazide|Atenolol 100 mg for 4 weeks followed by atenolol 100 mg + hydrochlorothiazide 12.5 mg for 4 weeks
16353943|NCT00232882|Drug|Thiazide Candesartan|Thiazide 25 mg for 4 weeks then added with Candesartan 16 mg
16353944|NCT00232869|Device|drug-eluting stent|Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
16353945|NCT00232869|Device|bare-metal stent|SMART™ bare-metal stent
16353946|NCT00232856|Device|drug-eluting stent|PCI
16353947|NCT00232843|Device|stent|Cordis SMART™ nitinol self-expanding stent.
16353948|NCT00232843|Device|angioplasty|balloon angioplasty
16353949|NCT00232830|Device|drug-eluting stent|Cypher Sirolimus-eluting Coronary Stent
16353950|NCT00232830|Device|bare-metal stent|any bare-metal stent brand
16353951|NCT00232817|Drug|Nicotine (drug)|nicotine nasal spray (3mg) before surgery
16353952|NCT00232804|Device|Bx Cypher stent|
16353953|NCT00232791|Device|Cypher Select|CYPHER SELECT™ Sirolimus-eluting Coronary Stent
16353954|NCT00232791|Device|Cypher|CYPHER™ Sirolimus-eluting Coronary Stent
16353955|NCT00232778|Device|GAMMA-Iridium-192 catheter|
16353956|NCT00232765|Device|CYPHER Sirolimus-Eluting Stent|CYPHER Sirolimus-Eluting Stent
16353957|NCT00232765|Device|Uncoated BX VELOCITY Balloon-Expandable Stent|Uncoated BX VELOCITY Balloon-Expandable Stent
16353958|NCT00232752|Device|4.0 CYPHER Sirolimus-Eluting Coronary Stent|4.0 CYPHER Sirolimus-Eluting Coronary Stent
16353959|NCT00232739|Device|CYPHER Sirolimus-eluting Coronary Stent|2.25 Cypher Sirolimus-eluting Coronary Stent
16353960|NCT00232726|Drug|CP-4055 (ELACYT)|
16353961|NCT00232700|Drug|Escitalopram|
16353962|NCT00232687|Drug|Aripiprazole|Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
16353963|NCT00232687|Drug|Aripiprazole|Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
16353964|NCT00232674|Drug|Pulmicort (budesonide) Turbuhaler|
16353965|NCT00232661|Drug|ARIMIDEX (anastrazole)|
16353966|NCT00232661|Drug|NOLVADEX (tamoxifen)|
16353967|NCT00232648|Drug|Pulmicort (budesonide) Respules|
16353968|NCT00232635|Drug|A-60444|
16353969|NCT00232622|Drug|Streptokinase|Accelerated infusion of streptokinase
16353970|NCT00232622|Drug|Streptokinase|Standard dose streptokinase
16353971|NCT00232609|Device|GameCycle Exercise System|
16353972|NCT00232596|Drug|Retigabine|Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase
16353973|NCT00232596|Drug|Placebo|Oral tablet.
16353974|NCT00232583|Drug|Metformin|Metformin 1000mg/BID
16353975|NCT00232583|Drug|Insulin|Insulin Novolg 70/30 per protocol titration
16353976|NCT00232583|Drug|Metfomin|Metformin 1000mg/BID
16353977|NCT00232583|Drug|Pioglitazone|Pioglitazone 45mg
16353978|NCT00232583|Drug|glyburide|Glyburide per protocol titration
16353979|NCT00232570|Drug|quetiapine|
16353980|NCT00232557|Device|TLC-Asthma|Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
16353981|NCT00232557|Device|TLC-health education|A telephone-linked communication system (TLC) to provide general health education.
16353982|NCT00232544|Device|Telecommunications system|The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.
16353983|NCT00232544|Other|TLC-Control|A TLC system for providing general health education
16353984|NCT00232531|Drug|Niaspan|
16353985|NCT00232518|Procedure|Infection with hookworm larvae|
16353986|NCT00232505|Biological|cetuximab|Given IV
16353987|NCT00232505|Drug|carboplatin|Given IV
16353988|NCT00232492|Drug|Placebo males|Intravenous saline bolus (Placebo-control) males
16353989|NCT00232492|Drug|Ketamine 0,1 mg/kg males|0,1 mg/kg ketamine iv bolus males
16353990|NCT00232492|Drug|Ketamine 0,3 mg/kg males|0,3 mg/kg ketamine iv bolus males
16353991|NCT00232492|Drug|Ketamine 0,5 mg/kg males|0,5 mg/kg ketamine iv bolus males
16353992|NCT00232492|Drug|Placebo females|Intravenous saline bolus (Placebo-control) females
16353993|NCT00232492|Drug|Ketamine 0,1 mg/kg females|0,1 mg/kg iv bolus ketamine females
16353994|NCT00232492|Drug|Ketamine 0,3 mg/kg females|0,3 mg/kg iv bolus ketamine females
16353995|NCT00232492|Drug|Ketamine 0,5 mg/kg females|0,5 mg/kg iv bolus ketamine females
16353996|NCT00232479|Drug|trastuzumab, docetaxel and carboplatin in dose dense regimen|trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44
16353997|NCT00232466|Procedure|Vertebroplasty|"Procedure:
~The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body (maximal 2 vertebrae in 1 treatment session) using fluoroscopic guidance. The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay."
16353998|NCT00232453|Procedure|Combined Radiation and Chemotherapy|
16353999|NCT00232440|Device|BodyFIX|
16354000|NCT00232427|Procedure|Hemodynamic monitoring system PiCCO|
16354001|NCT00232414|Drug|Quetiapine|
16354002|NCT00232388|Procedure|Blood draw|
16354003|NCT00232375|Drug|Insulin|
16354004|NCT00232362|Drug|Pioglitazone (Actos)|
16354005|NCT00232362|Drug|Anti-diabetic agent other than pioglitazone or rosiglitazone|
16354006|NCT00232349|Drug|galantamine|open label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d.
16354007|NCT00232336|Drug|quetiapine|
16354008|NCT00232323|Behavioral|simulation training|
16354009|NCT00232310|Drug|CELIVARONE (SSR149744C)|
16354010|NCT00232297|Drug|SSR149744C|
16354011|NCT00232284|Drug|sertraline|RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
16354012|NCT00232284|Behavioral|Cognitive Behavioural Therapy|An integrated 10-week CBT program for depression/anxiety and comorbid substance use
16354013|NCT00232271|Drug|Clexane|
16354014|NCT00232258|Drug|Nolpitantium besylate|
16354015|NCT00232245|Drug|Fish oil|
16354016|NCT00232232|Drug|Fish oil|
16354017|NCT00232219|Drug|Fish oil|
16354018|NCT00232206|Drug|Neoadjuvant Therapy with Cisplatin Plus Docetaxel|
16354019|NCT00232180|Drug|Eplerenone|Eplerenone administered on top of background standard heart failure therapy
16354020|NCT00232167|Drug|Indiplon|
16354021|NCT00232167|Drug|Sertraline|
16354022|NCT00232154|Drug|Zithromax&#153; (azithromycin) 500mg tablets|
16354023|NCT00232154|Procedure|Endoscopic Sinus Surgery|
16354024|NCT00232154|Procedure|Blood sampling for hematology|
16354025|NCT00232154|Procedure|Blood sampling for plasma chemistry profile|
16354026|NCT00232154|Procedure|Serum pregnancy test (for women of child-bearing potential)|
16354027|NCT00232141|Drug|pregabalin|75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)
16354028|NCT00232141|Drug|Placebo|Placebo
16354029|NCT00232128|Procedure|Radiofrequency Ablation of pulmonary neoplasms|
16354030|NCT00232115|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16354031|NCT00232115|Drug|Placebo|Vehicle cream (placebo)
16354032|NCT00232102|Drug|Tegaserod|
16354033|NCT00232089|Drug|Tegaserod|
16354034|NCT00232076|Drug|ciclosporin|
16354035|NCT00232063|Drug|ciclosporin|
16354036|NCT00232050|Drug|Omalizumab|
16354037|NCT00232037|Drug|Tegaserod|
16354038|NCT00232024|Drug|Tegaserod|
16354039|NCT00232011|Drug|Pimecrolimus Cream 1%|Pimecrolimus cream 1 %
16354040|NCT00231998|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16354041|NCT00231985|Behavioral|Habit reversal therapy|Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
16354042|NCT00231985|Behavioral|Supportive therapy|Supportive therapy focuses on educating participants about tics: how tics present themselves, the causes of tics, the common conditions that may occur along with tics, and environmental factors that may affect their tics (e.g. family, social, school, stress).
16354043|NCT00231972|Behavioral|Project Enhance|The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
16354044|NCT00231972|Behavioral|Standard prevention case management (PCM)|Participants will receive standard PCM for HIV prevention.
16354045|NCT00231959|Drug|Pramipexole (Mirapex)|pramipexole 0.5mg tablets qd and titrated per protocol
16354046|NCT00231959|Drug|Placebo|sugar pill
16354047|NCT00231946|Drug|VP4896|
16354048|NCT00231933|Behavioral|Person-centered planning (PCP)|PCP aids participants in discovering a vision of a desirable future and developing a plan for achieving that goal. Techniques include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of set backs as part of the path to success.
16354049|NCT00231933|Behavioral|Community integration (CI)|CI includes recovery group sessions and community integration activities.
16354050|NCT00231933|Behavioral|Illness management recovery (IMR)|IMR focuses on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs.
16354051|NCT00231920|Biological|Fluzone|
16354052|NCT00231907|Biological|FluMist|Live attenuated influenza vaccine (LAIV) containing approximately 10^7 TCID50 of each of the 3 influenza strains. 0.5 mL total dose volume administered intranasally via spray applicator (approximately 0.25 mL into each nostril). Administration of Flumist in children under 5 years of age is investigational.
16354053|NCT00231907|Biological|Fluzone|Trivalent inactivated vaccine (TIV), licensed Fluzone preservative free pediatric dose, 0.25 mL administered intramuscularly to the anterolateral thigh muscle or deltoid muscle.
16354054|NCT00231894|Drug|Pioglitazone|pioglitazone 30-45 mg/day
16354055|NCT00231894|Behavioral|Life style diet group|life style diet education group 1x/week
16354056|NCT00231894|Other|Placebo|placebo comparator capsules
16354057|NCT00231868|Drug|Carboplatin and Paclitaxel and Pelvic Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
16354058|NCT00231868|Procedure|Carboplatin and Paclitaxel and Pelvic Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
16354059|NCT00231868|Drug|Carboplatin and Paclitaxel and Radiation Therapy|Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
16354060|NCT00231855|Drug|Topotecan and Taxotere|
16354061|NCT00231842|Drug|Ifosfamide|Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
16354062|NCT00231842|Device|Radiation Therapy|Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
16354063|NCT00231842|Drug|Cisplatin|dosage is 20 mg/m2/day for 5 days, ever 3 weeks.
16354064|NCT00231829|Drug|Celecoxib|
16354065|NCT00231816|Biological|ZOSTAVAX™ (concomitant)|a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
16354066|NCT00231816|Biological|Comparator: Influenza Vaccine|a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
16354067|NCT00231816|Biological|ZOSTAVAX™ (Nonconcomitant)|Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
16354068|NCT00231803|Procedure|Combined CKD and CVD Prevention|
16354069|NCT00231803|Procedure|Cardiovascular Disease prevention|
16354070|NCT00231803|Procedure|Treatment of Chronic Kidney Disease complications|
16354071|NCT00231790|Drug|MK-0634 50 mg|one capsule orally, once daily in morning
16354197|NCT00230698|Drug|topiramate|
16354072|NCT00231790|Drug|MK-0634 125 mg|one or three capsules orally, once daily in morning
16354073|NCT00231790|Drug|Placebo for MK-0634|one, two, three or four capsules orally once daily in morning
16354074|NCT00231777|Drug|Comparator: MK0517|a single administration of 40 mg MK0517 by IV immediately prior to surgery
16354075|NCT00231777|Drug|Comparator: ondansetron|a single administration of 4 mg ondansetron by IV immediately prior to surgery
16354076|NCT00231764|Drug|daclizumab|
16354077|NCT00231738|Drug|Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)|
16354078|NCT00231725|Drug|insulin lispro injection [rDNA origin] Low Mix|
16354079|NCT00231699|Procedure|Plastic wrap (study group) and cotton (control group) wrap.|
16354080|NCT00231686|Behavioral|Supervised aerobic training|
16354081|NCT00231686|Behavioral|Supervised strength training|
16354082|NCT00231686|Behavioral|Unsupervised training|
16354083|NCT00231673|Drug|Topiramate|Increasing dosing of topiramate gradually to 200 mg daily by mouth, dose maintenance for 12 weeks, then decreasing dose until stopped over 12 weeks
16354084|NCT00231660|Drug|topiramate|
16354085|NCT00231647|Drug|topiramate|
16354086|NCT00231634|Drug|topiramate|
16354087|NCT00231621|Drug|topiramate|
16354088|NCT00231608|Drug|topiramate|
16354089|NCT00231595|Drug|topiramate|
16354090|NCT00231582|Drug|epirubicin|epirubicin
16354091|NCT00231582|Procedure|high-dose and autologous stem cell transplantation|high-dose and autologous stem cell transplantation
16354092|NCT00231582|Drug|paclitaxel|paclitaxel
16354093|NCT00231582|Drug|etoposide|etoposide
16354094|NCT00231582|Drug|ifosfamide|ifosfamide
16354095|NCT00231582|Drug|carboplatin|carboplatin
16354096|NCT00231569|Drug|ISIS 301012 or Placebo|30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
16354097|NCT00231569|Drug|ISIS 301012 or Placebo|100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
16354098|NCT00231569|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
16354099|NCT00231569|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
16354100|NCT00231569|Drug|ISIS 301012 or Placebo|400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
16354101|NCT00231569|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
16354102|NCT00231569|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
16354103|NCT00231556|Drug|topiramate|
16354104|NCT00231543|Procedure|Laparoscopic fundoplication|
16354105|NCT00231543|Procedure|open Nissen fundoplication|
16354106|NCT00231530|Drug|topiramate|
16354107|NCT00231517|Drug|topical opiod|
16354108|NCT00231517|Drug|morphine sulphate in intrasite gel|
16354109|NCT00231504|Procedure|Blood samples|Blood samples
16354110|NCT00231491|Drug|Botulinum Toxin A (Botox )|
16354111|NCT00231478|Drug|granisetron|20 micrograms intravenously (iv) 15 min prior to end of surgery
16354112|NCT00231478|Drug|granisetron|40 micrograms intravenously (iv) 15 min prior to end of surgery
16354113|NCT00231465|Drug|docetaxel (Taxotere®)|Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
16354114|NCT00231465|Drug|ZD1839|ZD1839 will be continued until progression, or until trial closure, whichever comes first.
16354115|NCT00231452|Drug|Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)|Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
16354116|NCT00231439|Drug|IvIg|
16354117|NCT00231426|Device|ICD|
16354118|NCT00231413|Biological|HPV 16/18 L1 AS04|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354119|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 1|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354120|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 2|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354121|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 3|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354122|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 4|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354123|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 5|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354124|NCT00231413|Biological|HPV-16/18/31/45 L1 AS04 Formulation 6|3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
16354125|NCT00231387|Drug|rosiglitazone|
16354126|NCT00231374|Procedure|Myelogram|
16354127|NCT00231348|Drug|Nefazodone|
16354128|NCT00231335|Drug|escitalopram|
16354129|NCT00231322|Drug|praziquantel|
16354130|NCT00231309|Drug|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor
16354131|NCT00231296|Device|Cardiac CryoCor Cryoablation System|Treatment with CryoCor Cardiac Cryoablation system
16354132|NCT00231296|Drug|Medical management|Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
16354133|NCT00231283|Device|CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
16354134|NCT00231270|Device|Cordis Nitinol Stent|
16354135|NCT00231270|Device|PRECISE tapered stent|
16354136|NCT00231270|Device|ANGIOGUARD XP Emboli Capture Guidewire (ECGW)|
16354137|NCT00231257|Device|Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent|Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
16354138|NCT00231257|Procedure|Brachytherapy|Brachytherapy
16354139|NCT00231244|Device|CYPHER Sirolimus-Eluting Coronary Stent|CYPHER Sirolimus-Eluting Coronary Stent
16354140|NCT00231231|Device|-PRECISE Nitinol Stent System (5F, 5.5F and 6F)|
16354141|NCT00231231|Device|ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)|
16354142|NCT00231218|Drug|dietary supplement--echinacea, propolis, and vitamin c|
16354143|NCT00231205|Procedure|Revascularization|
16354144|NCT00231192|Drug|Repaglinide and Insulin|
16354145|NCT00231179|Behavioral|Home visiting professional support model|Home visits and telephone calls keyed to well child visits.
16354146|NCT00231179|Other|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information
16354147|NCT00231166|Drug|HCD122|
16354148|NCT00231153|Drug|Omiganan 1% gel|Patients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.
16354149|NCT00231153|Drug|Povidone-Iodine 10%|All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine.
16354150|NCT00231140|Drug|Thalidomide (drug)|
16354151|NCT00231114|Device|Alair System|Treatment of airways with the Alair System
16354152|NCT00231114|Device|Alair System|Sham treatment of airways with the Alair System
16354153|NCT00231101|Drug|Quetiapine|
16354154|NCT00231075|Drug|Paraplatin|
16354155|NCT00231075|Drug|Paclitaxel|
16354156|NCT00231062|Device|Sinuplasty|
16354157|NCT00231049|Drug|AG-707|
16354158|NCT00231023|Drug|Peribulbar Triamcinolone Acetonide|
16354159|NCT00230997|Drug|Galantamine|
16354160|NCT00230984|Behavioral|education|
16354161|NCT00230984|Drug|Oral dietary supplements (563 kcal/d), RESPIFOR|
16354162|NCT00230984|Behavioral|exercises on an ergometric bicycle 3 to 5 times a week|
16354163|NCT00230984|Drug|160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women|
16354164|NCT00230971|Drug|tigecycline|every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
16354165|NCT00230971|Drug|ceftriaxone plus metronidazole|Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
16354166|NCT00230958|Drug|Viramidine|
16354167|NCT00230958|Drug|Ribavirin|
16354168|NCT00230958|Drug|pegylated interferon alfa-2b|
16354169|NCT00230945|Behavioral|education and support intervention|The patient-oriented education and support intervention (PES) is based on the Arthritis Self-Management Program, a group intervention that consists of 6 weekly 2 hour sessions shown to successfully reduce pain severity and depressive symptomatology and to enhance a sense of efficacy in managing arthritis pain and other symptoms. The couple-oriented education and support intervention (CES) is a group education and support intervention that consisted of 6 weekly 2 hour sessions attended by individuals with OA and their spouses. All components of the PES are covered in the CES using the standard format, and topics are framed as couples' issues whenever possible.
16354170|NCT00230919|Behavioral|Diet counseling|
16354171|NCT00230906|Procedure|Haemodialysis with either low or high flux membranes|
16354172|NCT00230880|Behavioral|follow-up phone counseling|9 calls over 12 months
16354173|NCT00230867|Device|iontophoretic acyclovir|
16354174|NCT00230854|Drug|EMZ702|
16354175|NCT00230841|Device|nebulized humidity|
16354176|NCT00230828|Drug|bifeprunox|
16354177|NCT00230815|Device|Follitropin alfa injected by Pen device|Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.
16354178|NCT00230815|Device|Recombinant Human Choriogonadotropin (r-hCG)|Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.
16354179|NCT00230802|Drug|Anticipatory dose increase of levothyroxine|as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
16354180|NCT00230802|Drug|levothyroxine|patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
16354181|NCT00230802|Drug|levothyroxine|patients will increase levothyroxine by 3 extra tablets of their current dose per week.
16354182|NCT00230789|Drug|Tolterodine ER 4 mg QD|
16354183|NCT00230789|Behavioral|OAB Patient Behavioral Training Material|
16354184|NCT00230776|Drug|pregabalin|
16354185|NCT00230776|Drug|placebo|
16354186|NCT00230763|Procedure|GSS questionnaire|D0, D30 and D84
16354187|NCT00230763|Procedure|IOP|D0, D30 and D84
16354188|NCT00230763|Drug|LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION|in the evening during 84 days
16354189|NCT00230763|Procedure|Visual acuity|D0 and D84
16354190|NCT00230750|Biological|Influenza A/H5N1 Vaccine|Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 90-mcg/mL. Dosages: 45 mcg or 90 mcg administered intramuscularly.
16354191|NCT00230750|Drug|Placebo|Saline placebo.
16354192|NCT00230737|Drug|Melatonin 0.4 mg|
16354193|NCT00230737|Drug|Melatonin 4.0 mg|
16354194|NCT00230737|Drug|Placebo|
16354195|NCT00230724|Behavioral|Exercise Counseling|
16354196|NCT00230711|Behavioral|Physical activity counseling|
16354198|NCT00230659|Other|Blood sample to be taken.|Blood sample to be taken.
16354199|NCT00230646|Behavioral|Exercise counseling|
16354200|NCT00230607|Drug|agalsidase beta|Pharmaceutical form: powder for reconstitution Route of administration: intravenous
16354201|NCT00230594|Drug|desmopressin|desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
16354202|NCT00230594|Drug|placebo|placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
16354203|NCT00230581|Drug|DDP225|
16354204|NCT00230568|Drug|Aricept|
16354205|NCT00230555|Behavioral|professional support model|
16354206|NCT00230542|Drug|Carboplatin|Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
16354207|NCT00230542|Drug|Pemetrexed|Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
16354208|NCT00230529|Drug|infliximab|
16354209|NCT00230516|Drug|Nexium|
16354210|NCT00230516|Drug|Prevacid|
16354211|NCT00230503|Drug|pradefovir mesylate|
16354212|NCT00230503|Drug|adefovir dipivoxyl|
16354213|NCT00230490|Drug|pradefovir mesylate|
16354214|NCT00230490|Drug|adefovir dipivoxyl|
16354215|NCT00230477|Drug|Hepsera|
16354216|NCT00230477|Drug|Hepsera and lamivudine|
16354217|NCT00230464|Drug|LAF 237|
16354218|NCT00230451|Procedure|Radiation|
16354219|NCT00230451|Drug|Paclitaxel|
16354220|NCT00230451|Drug|Cisplatin|
16354221|NCT00230451|Drug|5-Fluorouracil|
16354222|NCT00230438|Procedure|External Beam Radiotherapy|
16354223|NCT00230399|Drug|Celecoxib|
16354224|NCT00230399|Drug|Capecitabine|
16354225|NCT00230399|Drug|Irinotecan|
16354226|NCT00230386|Device|MRI|
16354227|NCT00230373|Drug|imiquimod 5% cream (Aldara)|
16354228|NCT00230347|Procedure|Stereotactic radiosurgery|
16354229|NCT00230334|Drug|Gleevec|
16354230|NCT00230321|Drug|Darbepoetin alfa|During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously.If patients do not achieve a major erythroid response by 6 weeks, the dose of DARBEPOETIN ALFA will be doubled to 9.0 ug/kg/week.
16354231|NCT00230295|Procedure|IMR LAG|
16354232|NCT00230282|Drug|Alemtuzumab|3 to 30 mg, IV
16354233|NCT00230282|Drug|Fludarabine|[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid
16354234|NCT00230282|Drug|Cytoxan|(RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide
16354235|NCT00230269|Procedure|PET-CT|
16354236|NCT00230230|Drug|SCH 486757|
16354237|NCT00230217|Drug|Rasburicase (SR29142)|
16354238|NCT00230204|Procedure|Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits|
16354239|NCT00230191|Drug|RK-0202|
16354240|NCT00230178|Drug|Rasburicase (SR29142)|30-min IV infusion
16354241|NCT00230178|Drug|Allopurinol|Oral administration
16354242|NCT00230152|Device|Imaging|
16354243|NCT00230139|Device|SPECT/CT|
16354244|NCT00230126|Drug|erlotinib|Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
16354245|NCT00230113|Dietary Supplement|Omega-3 fatty acid diet supplementation|4 gm fish oil per day
16354246|NCT00230113|Dietary Supplement|safflower oil|4 gm per day safflower oil
16354247|NCT00230100|Behavioral|The Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
16354248|NCT00230100|Behavioral|mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
16354249|NCT00230087|Procedure|blood donation|phlebotomy until iron depleted
16354250|NCT00230074|Drug|TCH346|
16354251|NCT00230061|Biological|HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml|
16354252|NCT00230048|Behavioral|Brief computer-delivered intervention|Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
16354253|NCT00230035|Procedure|Leukapheresis|
16354254|NCT00230035|Procedure|Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)|
16354255|NCT00230035|Procedure|Autologous CD34+HPC transplantation (HSCT)|
16354256|NCT00230035|Procedure|Plasmapheresis|
16354257|NCT00230035|Drug|Rabbit anti-thymocyte globulin|
16354258|NCT00230035|Drug|Methylprednisolone|
16354259|NCT00230035|Drug|Growth colony stimulating factor (G-CSF)|
16354260|NCT00230035|Drug|Corticosteroids|
16354261|NCT00230035|Drug|Mycophenolate mofetil|
16354262|NCT00230035|Drug|Azathioprine|
16354263|NCT00230035|Drug|Intravenous immunoglobulin|
16354264|NCT00230035|Drug|Methotrexate|
16354265|NCT00230035|Drug|Rituximab|
16354266|NCT00230035|Drug|Leflunomide|
16354267|NCT00230022|Behavioral|Brief computer-delivered intervention|20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
16354268|NCT00230009|Behavioral|Brief motivational intervention|
16354269|NCT00229996|Drug|Oral Contraceptive|
16354270|NCT00229996|Drug|Depot-Leuprolide/Norethindrone|
16354271|NCT00229983|Behavioral|Motivational Enhancement Therapy|Three 60 minute counseling sessions using a structured, developmentally appropriate approach to identification of drug- and alcohol- related risks and problems, and establishment of goals for behavioral change.
16354272|NCT00229970|Drug|montelukast sodium|7 mg or 14 mg single injection
16354273|NCT00229970|Drug|Comparator: Placebo|Placebo single injection
16354274|NCT00229957|Behavioral|Occupational therapy|
16354275|NCT00229957|Behavioral|Physiotherapy|
16354276|NCT00229957|Behavioral|Self-management|
16354277|NCT00229944|Drug|Azithromycin|
16354278|NCT00229931|Drug|Triamcinolone acetonide|4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
16354279|NCT00229931|Procedure|laser|Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
16354280|NCT00229918|Drug|triamcinolone acetonide|
16354281|NCT00229840|Procedure|Functional MRI, Diffusion Tensor Imaging|
16354282|NCT00229801|Radiation|MRI|
16354283|NCT00229775|Drug|artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine|
16354284|NCT00229762|Behavioral|phone call from nurses - informational only|
16354285|NCT00229749|Drug|AVI-4065 Injection|
16354286|NCT00229736|Genetic|AAV-hAADC-2|9 x 10^10 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
16354287|NCT00229736|Genetic|AAV-hAADC-2|3 x 10^11 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
16354288|NCT00229723|Drug|gefitinib (Iressa)|250 mg oral tablet
16354289|NCT00229723|Drug|cisplatin|intravenous infusion
16354290|NCT00229723|Radiation|radiotherapy|radiation therapy
16354291|NCT00229723|Drug|Gefitinib (Iressa)|500 mg oral tablet
16354292|NCT00229710|Drug|Tesaglitazar|0.5 in combination with insulin (with or without other oral antidiabetic drugs)
16354293|NCT00229697|Drug|Gefitinib|
16354294|NCT00229697|Drug|Tamoxifen|
16354295|NCT00229684|Drug|Tesaglitazar|2 mg once daily in oral form
16354296|NCT00229684|Drug|pioglitazone|45 mg once daily in oral form
16354297|NCT00229671|Other|Survey 1|During the initial survey, we reviewed dispensed medications by having parents of patients with prescriptions under 21 read the medication label. We then asked questions about potential side effects, method of medication administration, communication regarding the medication with the pharmacist and the health care provider, and demographic information. Research assistants underwent several weeks of training to ensure a standardized approach to surveys.
16354298|NCT00229671|Other|Survey 2|If the parent completed the initial survey, we attempted a second survey 2 months after the index visit to capture persistent symptoms. Surveys were translated and back translated into Spanish and Cambodian and conducted by fluent bilingual interviewers. Surveys were pretested and revised based on 2 focus groups of parents representing a broad array of socioeconomic backgrounds.
16354299|NCT00229658|Drug|pramlintide acetate|Subcutaneous injection prior to each major meal
16354300|NCT00229645|Drug|Quetiapine Fumarate (Seroquel®)|
16354301|NCT00229632|Drug|Idebenone|Idebenone is a short-chain benzoquinone derivative of similar structure to ubiquinone (coenzyme Q10). This compound was synthesized and developed initially by Takeda Chemical Industries, Ltd. (Osaka, Japan) and designated as CV-2619. The chemical name for idebenone is 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benxoquinone. Santhera Pharmaceuticals (Liestal, Switzerland) LLC, will supply drug for this study as specified by a clinical trial agreement.
16354302|NCT00229619|Drug|Rituximab|Rituximab (Rituxan) 375mg/m2 intravenous infusion. The infusion will be once every week for a total of 4 doses.
16354303|NCT00229593|Drug|Nestorone gel|2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
16354304|NCT00229593|Drug|Testosterone Gel|100 mg Testosterone gel daily for 3 weeks
16354305|NCT00229580|Behavioral|3 session brief intervention with health behavior feedback|
16354306|NCT00229580|Other|treatment as usual|
16354307|NCT00229567|Drug|Lidocaine infusion plus ketamine injection|
16354308|NCT00229541|Procedure|Counselling and 3-week medical in-patient rehabilitation|Counselling and 3-week medical in-patient rehabilitation in IG
16354309|NCT00229528|Drug|Paxil-CR|
16354310|NCT00229515|Other|abciximab followed by implantation of bare metal stent|Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
16354311|NCT00229515|Other|abciximab and Sirolimus eluting stent|Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
16354312|NCT00229515|Other|tirofiban and bare metal stent|Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation
16354313|NCT00229515|Other|tirofiban and sirolimus-eluting stent|Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation
16354314|NCT00229476|Drug|sertraline (Zoloft)|
16354315|NCT00229450|Drug|Estrogen|0.625 mg/day of conjugated Estrogen
16354316|NCT00229437|Drug|TAK-128|TAK-128 5 mg, tablets, orally, once daily for up to 6 months.
16354317|NCT00229437|Drug|TAK-128|TAK-128 50 mg, tablets, orally, once daily for up to 6 months.
16354318|NCT00229437|Drug|TAK-128|TAK-128 100 mg, tablets, orally, once daily for up to 6 months.
16354319|NCT00229437|Drug|Placebo|TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.
16354320|NCT00229424|Drug|Lafutidine|Oral administration of lafutidine by 20mg/day along with famotidine placebo
16354321|NCT00229424|Drug|Famotidine|Oral administration of famotidine by 40mg/day along with lafutidine placebo
16354322|NCT00229424|Other|Placebo|Oral administration of lafutidine placebo along with famotidine placebo
16354323|NCT00229411|Behavioral|simulation training|
16354324|NCT00229385|Drug|Ziprasidone|40-80 mg BID
16354325|NCT00229372|Behavioral|Prolonged Exposure (PE) therapy|
16354327|NCT00229320|Behavioral|Group therapy|
16354328|NCT00229307|Behavioral|Prolonged Exposure (PE) therapy|20 minutes exposure
16354329|NCT00229307|Behavioral|Prolonged Exposure (PE) therapy|40 minutes exposure
16354330|NCT00229281|Behavioral|Group therapy|
16354331|NCT00229255|Other|high frequency of meals|high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
16354332|NCT00229255|Other|twice a day meals|high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
16354333|NCT00229242|Drug|Diuretic-Based or Non-Diuretic Based Hypertension Therapy|
16354334|NCT00229229|Other|Low glycemic load diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
16354335|NCT00229229|Other|Canada Food Guide Diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
16354336|NCT00229229|Other|Low glycemic index diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
16354337|NCT00229229|Other|Low carbohydrate diet|A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
16354338|NCT00229216|Drug|Tinidazole|
16354339|NCT00229203|Drug|Plitidepsin|3-hour infusion every 2 weeks alone or in combination with dexamethasone
16354340|NCT00229190|Procedure|Nasal lavage|
16354341|NCT00229190|Procedure|Allergy skin testing|
16354342|NCT00229190|Procedure|Peak nasal inspiratory flow|
16354343|NCT00229190|Procedure|Acoustic rhinometry|
16354344|NCT00229190|Procedure|Nasal examination|
16354345|NCT00229190|Procedure|Quality of Life Questionnaire|
16354346|NCT00229190|Procedure|Physical examination|
16354347|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
16354348|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
16354349|NCT00229177|Drug|ONO-2506|Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
16354350|NCT00229164|Device|Transcutaneous Electric Nerve Stimulation (TENS)|
16354351|NCT00229151|Behavioral|Sleep deprivation and sleep phase advancement|Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.
16354352|NCT00229151|Other|usual treatment|Treatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria
16354353|NCT00229138|Drug|EC-MPS, Tacrolimus|
16354354|NCT00229125|Drug|Gabapentin|
16354355|NCT00229125|Drug|Lorazepam|
16354356|NCT00229112|Drug|MK0826, ertapenem sodium / Duration of Treatment - 24 weeks|
16354357|NCT00229112|Drug|Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks|
16354358|NCT00229099|Drug|GerEPO|
16354359|NCT00229086|Device|Gatekeeper Reflux Repari System (Device)|
16354360|NCT00229073|Drug|dapoxetine|
16354361|NCT00229060|Drug|doripenem|
16354362|NCT00229021|Drug|doripenum|
16354363|NCT00229008|Drug|ceftobiprole plus placebo|ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
16354364|NCT00229008|Drug|linezolid plus ceftazidime|linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
16354365|NCT00228995|Drug|epoetin alfa|
16354366|NCT00228982|Drug|Ceftobiprole medocaril|
16354367|NCT00228982|Drug|Vancomycin|
16354368|NCT00228969|Drug|RWJ-333369|
16354369|NCT00228956|Drug|pharmacodynamic analysis|Exemestane 25mg po daily or Letrozole 2.5mg po daily
16354370|NCT00228943|Dietary Supplement|Acute tryptophan depletion|L-alanine (5.5g), L-arginine (4.9g), L-cysteine (2.7g), glycine (3.2g), L-histidine (3.2g), L-isoleucine (8.0g), L-leucine (13.5g), L-lysine (11.0g), L-methionine (3.0g), L-phenylalanine (5.7g), L-proline (12.2g), L-serine (6.9g), L-threonine (6.9g), L-tyrosine (6.9g), L-valine (8.9g)
16354371|NCT00228943|Dietary Supplement|Half-strength tryptophan depletion (Control)|L-alanine (1.4g), L-arginine (1.2g), L-cysteine (0.7g), glycine (0.8g), L-histidine (0.8g), L-isoleucine (2.0g), L-leucine (3.4g), L-lysine (2.8g), L-methionine (0.8g), L-phenylalanine (1.4g), L-proline (3.1g), L-serine (1.7g), L-threonine (1.7g), L-tyrosine (1.7g), L-valine (2.2g), and fillers (7.95g).
16354372|NCT00228930|Drug|Tamoxifen (pharmacodynamic analysis)|Tamoxifen 20mg po daily
16354373|NCT00228917|Biological|Tritanrix-HepB/Hib-MenAC|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
16354374|NCT00228917|Biological|Tritanrix-HepB/Hiberix|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
16354375|NCT00228917|Biological|Mencevax-ACWY|Meningococcal Serogroups A, C, W-135 and Y Vaccine
16354376|NCT00228904|Procedure|Placebo|Control patients diagnosed with diabetic neuropathy are tested at baseline and every six months thereafter to compare to patients treated with pulsatile intravenous insulin therapy
16354377|NCT00228904|Procedure|Pulsatile IV insulin delivery (humalog, humulin, novolog)|Patients with diagnosed diabetic neuropathy have objective testing and questionnaires performed at baseline and every six months thereafter to evaluate and analyze progress of diabetic neuropathy after start of treatment of pulsatile intravenous insulin therapy
16354378|NCT00228891|Procedure|Effect of Pulsatile IV insulin on diabetic neuropathy|Control patients with diagnosed diabetic neuropathy will have objective testing at baseline and every six months to compare and measure results to patients receiving pulsatile intravenous insulin therapy.
16354379|NCT00228891|Procedure|Effect of Pulsatile IV Insulin on diabetic neuropathy|Patients diagnosed with diabetic neuropathy will be treated with pulsatile intravenous insulin on a weekly basis. Patient's Endocrinologist will determine the dosage of intravenous insulin to be given each week based upon the patient's response and insulin resistance.
16354380|NCT00228878|Procedure|Effects of Pulsatile IV insulin on Diabetic Quality of Life|Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment and their insulin resistance.
16354526|NCT00227565|Drug|pemetrexed disodium|
16354527|NCT00227565|Radiation|radiation|
16354528|NCT00227539|Drug|cisplatin|
16354381|NCT00228865|Procedure|Pulsatile IV insulin therapy|Diabetic pts are given pulsatile iv insulin on a weekly basis determined by weekly phys orders based on pt response and insulin resistance. Cognitive testing is performed quarterly to track progress
16354382|NCT00228865|Procedure|Effects of Pulsatile IV Insulin on Cognitive functions|Diabetic patients receive weekly treatment of Pulsatile Intravenous Insulin therapy. Dosage is determined each week by the patient's Endocrinologist based upon the patient's response and insulin resistance.
16354383|NCT00228852|Drug|Busulfan, Fludarabine and ATG|
16354384|NCT00228839|Drug|Infliximab|
16354385|NCT00228813|Drug|Granulocyte Colony Stimulating Factor|"FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously. It is given beginning on day -3 for 3 days to the donor prior to the bone marrow harvest.
~Drug Information: FILGRASTIM: G-CSF (Neupogen®) Formulation: G-CSF is available as a preservative-free solution for injection in 1.0 ml and 1.6 ml vials containing 300 mcg/ml.
~Administration: G-CSF 5 mcg/kg/d will be given subcutaneously or as a short I.V. infusion over 30 minutes.
~Recombinant GM-CSF at the dose of 250 mcg/m2 will be given intravenously from day +7 to help white counts recovery. The drug will be diluted in NS at a concentration of at least 10 mcg/ml.
~Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection"
16354386|NCT00228696|Other|none, screening only|Screening protocol with no intervention
16354387|NCT00228683|Procedure|Biology Study and Tissue Banking|Collection of specimens from Hepatoblastoma patients.
16354388|NCT00228657|Drug|4% Albumin / 0.9% Sodium Chloride|
16354389|NCT00228605|Drug|OraVescent Fentanyl|
16354390|NCT00228592|Drug|HepeX-B|
16354391|NCT00228592|Drug|Hepatitis B Immune Globulin (HBIg)|
16354392|NCT00228566|Drug|Armodafinil|
16354393|NCT00228553|Drug|Armodafinil 100 to 250 mg/day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
16354394|NCT00228540|Drug|Modafinil|
16354395|NCT00228527|Drug|Esomeprazole (Nexium)|
16354396|NCT00228514|Drug|Rosuvastatin|
16354397|NCT00228514|Procedure|Positron emission tomography|
16354398|NCT00228488|Drug|Gefitinib|
16354399|NCT00228475|Drug|Pulmicort (budesonide) Turbuhaler|
16354400|NCT00228462|Drug|Seroquel (quetiapine)|
16354401|NCT00228449|Drug|peginesatide|
16354402|NCT00228436|Drug|peginesatide|
16354403|NCT00228423|Drug|Clopidogrel 75 mg daily|Daily dose of 75 mg Clopidogrel
16354404|NCT00228423|Drug|water pill daily|Daily dose of water pill (placebo)
16354405|NCT00228410|Drug|Tigecycline|
16354406|NCT00228410|Drug|vancomycin with aztreonam|
16354407|NCT00228397|Drug|CCI-779|
16354408|NCT00228384|Device|GORE VIABAHN Endoprosthesis|Implantation
16354409|NCT00228384|Device|Bare Nitinol Stent|Implantation
16354410|NCT00228371|Device|Neurostimulation|High frequency neurostimulation of subthalamic nucleus : quadrupolar electrode, type 3389, n° : I7 02 08 39709 158, Medtronic, Minneapolis, USA
16354411|NCT00228358|Drug|ex vivo-expanded HER2-specific T cells|Laboratory-expanded T cells, given IV
16354412|NCT00228358|Drug|cyclophosphamide|Given IV
16354413|NCT00228358|Biological|denileukin diftitox|Given IV
16354414|NCT00228358|Other|flow cytometry|Intracellular cytokine staining (correlative study)
16354415|NCT00228358|Other|immunoenzyme technique|ELIspot assay (correlative study)
16354416|NCT00228345|Procedure|Optical coherence tomography,Fluorescein angiography|
16354417|NCT00228332|Drug|Administration of zinkgluconaat or placebo|
16354418|NCT00228319|Dietary Supplement|Oral Ascorbic Acid|4 grams per day for 12 months
16354419|NCT00228319|Drug|Paclitaxel|Six cycles
16354420|NCT00228319|Drug|Carboplatin|Six cycles
16354421|NCT00228319|Drug|Sodium Ascorbate|Intravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months
16354422|NCT00228319|Dietary Supplement|Oral Mixed natural Carotenoids with Vitamin A|Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
16354423|NCT00228319|Dietary Supplement|Vitamin E|500 IU per capsule and participant to take 1 capsule daily for 12 months
16354424|NCT00228306|Behavioral|Rehabilitation exercise|Rehab therapy is delivered for 8 weeks.
16354425|NCT00228293|Device|investigational monitor/defibrillator with CPR feedback|
16354426|NCT00228280|Procedure|Mineral Trioxide Aggregate (MTA)|retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha
16354427|NCT00228267|Drug|Propofol|
16354428|NCT00228254|Drug|Zinc (12.5 mg/day)|
16354429|NCT00228254|Drug|vitamin A 10,000 IU per week|
16354430|NCT00228241|Device|AAI vs. DDD vs. BIV pacing in different patients groups|
16354431|NCT00228228|Biological|T cell vaccination|
16354432|NCT00228215|Behavioral|TIPS Intervention|A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
16354433|NCT00228189|Biological|CEA-loaded dendritic cell vaccine|Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.
16354434|NCT00228176|Drug|Rimonabant|Tablet, oral administration
16354435|NCT00228176|Drug|Placebo (for Rimonabant)|Tablet, oral administration
16354436|NCT00228163|Drug|teriflunomide (HMR1726)|tablet, oral administration once daily.
16354437|NCT00228150|Drug|SR57667B|
16354438|NCT00228098|Behavioral|Smoking cessation|
16354439|NCT00228072|Procedure|Suction-curettage|
16354440|NCT00228059|Drug|Licarbazepine|
16354441|NCT00228046|Drug|Divalproex Sodium|
16354442|NCT00228046|Drug|Methylphenidate|
16354443|NCT00228046|Drug|Dextroamphetamine|
16354444|NCT00228046|Drug|Mixed Amphetamine Salts|
16354445|NCT00228046|Behavioral|Family Counseling|
16354446|NCT00228046|Behavioral|Behavior Management Training with Parents|
16354447|NCT00228033|Drug|Elemental calcium (as carbonate)|
16354448|NCT00228020|Drug|basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)|
16354449|NCT00228020|Drug|MMF, cyclosporine, steroids|
16354450|NCT00228007|Drug|Antidepressant Medication|
16354451|NCT00227994|Drug|Galantamine|Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.
16354452|NCT00227994|Drug|Donepezil|Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
16354453|NCT00227981|Behavioral|Interpersonal Psychotherapy|
16354454|NCT00227981|Drug|Fluoxetine|
16354455|NCT00227968|Behavioral|Interpersonal Social Rhythm Therapy (IPSRT)|
16354456|NCT00227968|Behavioral|Clinical Status and Symptom Response Therapy (CSSRT)|
16354457|NCT00227955|Drug|Imipramine|
16354458|NCT00227955|Behavioral|Interpersonal Psychotherapy|
16354459|NCT00227942|Drug|Estrogen Replacement Therapy|17-b-Estradiol Patch, .05 mg/day; applied for 7 days
16354460|NCT00227942|Drug|Zolpidem|10 mg/day, po qhs
16354461|NCT00227942|Drug|placebo|placebo
16354462|NCT00227929|Procedure|Care Management|
16354463|NCT00227916|Behavioral|Behavior Therapy|
16354464|NCT00227903|Behavioral|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
16354465|NCT00227903|Behavioral|Brief Advice|Advice and education
16354466|NCT00227890|Behavioral|MI/CBT|
16354467|NCT00227890|Behavioral|RT/TU|
16354468|NCT00227877|Behavioral|cSBA - New England, USA|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
16354469|NCT00227877|Behavioral|cSBA - Prague, CZR|"Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use."
16354470|NCT00227864|Behavioral|Behavior Therapy|
16354471|NCT00227864|Other|Treatment as Usual|
16354472|NCT00227838|Behavioral|Behavior Therapy|
16354473|NCT00227825|Behavioral|Motivational interviewing|
16354474|NCT00227812|Drug|Bupropion|
16354475|NCT00227786|Behavioral|smoking cessation intervention|
16354476|NCT00227786|Other|counseling intervention|
16354477|NCT00227773|Drug|octreotide acetate|
16354478|NCT00227773|Drug|vatalanib|
16354479|NCT00227773|Procedure|anti-cytokine therapy|
16354480|NCT00227773|Procedure|antiangiogenesis therapy|
16354481|NCT00227773|Procedure|biological therapy|
16354482|NCT00227773|Procedure|endocrine therapy|
16354483|NCT00227773|Procedure|enzyme inhibitor therapy|
16354484|NCT00227773|Procedure|growth factor antagonist therapy|
16354485|NCT00227773|Procedure|hormone therapy|
16354486|NCT00227773|Procedure|protein tyrosine kinase inhibitor therapy|
16354487|NCT00227773|Procedure|somatostatin analogue therapy|
16354488|NCT00227760|Drug|Cediranib Maleate|Given PO
16354489|NCT00227760|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
16354490|NCT00227760|Other|Laboratory Biomarker Analysis|Correlative studies
16354491|NCT00227760|Other|Pharmacological Study|Correlative studies
16354492|NCT00227747|Drug|capecitabine|
16354493|NCT00227747|Drug|oxaliplatin|
16354494|NCT00227747|Procedure|conventional surgery|
16354495|NCT00227747|Procedure|neoadjuvant therapy|
16354496|NCT00227747|Radiation|radiation therapy|
16354497|NCT00227734|Drug|capecitabine and oxaliplatin + cetuximab|cetuximab
16354498|NCT00227734|Drug|capecitabine and oxaliplatin|capecitabine and oxaliplatin without cetuximab
16354499|NCT00227721|Drug|Docetaxel|40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
16354500|NCT00227721|Drug|Gemcitabine hydrochloride|800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
16354501|NCT00227708|Drug|docetaxel|
16354502|NCT00227708|Procedure|quality-of-life assessment|
16354503|NCT00227695|Biological|rituximab|comparing two maintenance schedules of Rituximab
16354504|NCT00227682|Dietary Supplement|ascorbic acid|
16354505|NCT00227682|Drug|arsenic trioxide|
16354506|NCT00227682|Drug|dexamethasone|
16354507|NCT00227682|Drug|thalidomide|
16354508|NCT00227669|Drug|docetaxel|
16354509|NCT00227669|Drug|gemcitabine hydrochloride|
16354510|NCT00227656|Biological|PEG-interferon alfa-2a|Once a week subcutaneous injection for 21 days, beginning at 180 mcg per week. Repeated for additional 21 days to begin at the same time as repeat 21 day Capecitabine cycle.
16354511|NCT00227656|Drug|Capecitabine|1000 mg/m^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).
16354512|NCT00227630|Drug|cisplatin|
16354513|NCT00227630|Drug|pemetrexed disodium|
16354514|NCT00227630|Procedure|adjuvant therapy|
16354515|NCT00227630|Procedure|conventional surgery|
16354516|NCT00227630|Procedure|neoadjuvant therapy|
16354517|NCT00227630|Radiation|radiation therapy|
16354518|NCT00227617|Biological|bevacizumab|5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
16354519|NCT00227617|Drug|5-fluorouracil|2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
16354520|NCT00227617|Drug|leucovorin|200mg/m2 IV q2 wk on day 1 over a 2-hour period.
16354521|NCT00227617|Drug|oxaliplatin|200mg/m2 IV q 2 wk on day 1 over a 2-hour period
16354522|NCT00227591|Drug|lenalidomide|Given orally (PO)
16354523|NCT00227591|Drug|prednisone|Given PO
16354524|NCT00227591|Other|laboratory biomarker analysis|Correlative studies
16354525|NCT00227565|Drug|carboplatin|
16354529|NCT00227539|Drug|pemetrexed disodium|
16354530|NCT00227539|Procedure|adjuvant therapy|
16354531|NCT00227539|Procedure|therapeutic conventional surgery|
16354532|NCT00227539|Radiation|fludeoxyglucose F 18|
16354533|NCT00227526|Behavioral|Prehabilitation|
16354534|NCT00227513|Drug|bortezomib|Given IV
16354535|NCT00227513|Drug|vorinostat|Given orally
16354536|NCT00227500|Drug|Pravastatin|
16354537|NCT00227487|Other|Stool collection|Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout
16354538|NCT00227487|Other|Administration of carbohydrate solution during clinically indicated endoscopy|"A carbohydrate solution (lactulose + rhamnose dissolved in tap water) will be administered during the procedure (upper endoscopy) through a catheter directly into the duodenum to allow for intestinal permeability analysis.
~Clinically indicated pinch biopsies will then be obtained.
~The endoscopy procedures will take at least 1 - 1 ½ hours.
~Children will then typically recover in the endoscopy suite for 2 - 2½ hours or less, if the child is medically cleared to leave the endoscopy suite sooner.
~Urine for intestinal permeability analysis will be collected during 5 hours after carbohydrate solution administration. If the child has not voided, an additional 60 minutes will be allowed for the child to void. If the child is not continent for urine, a bag will be applied to catch the specimen."
16354539|NCT00227487|Other|Questionnaires|Parents/legal guardians of subjects will be asked to complete five (5) questionnaires: the Gastrointestinal Symptoms Inventory; a Developmental Screening for Autism - based on the child's age, either the Checklist for Autism in Toddlers (CHAT), Modified Checklist for Autism in Toddlers (M-CHAT), or the Social Communication Questionnaire (SCQ); the Behavior and Sensory Interest Questionnaire (BSI), the Behavior Problems Inventory (BPI), and the Aberrant Behavior Checklist (ABC). It should take parents/guardians no longer than eighty-five (85) minutes to complete all 5 surveys. Results from these questionnaires will be correlated with documented gastrointestinal and/or neurological diagnostic information from subject medical records and with research study test results.
16354540|NCT00227474|Drug|recombinant modified vaccinia Ankara-5T4 vaccine|
16354541|NCT00227474|Procedure|adjuvant therapy|
16354542|NCT00227474|Procedure|recombinant viral vaccine therapy|
16354543|NCT00227461|Drug|Wait first, then levetiracetam|Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.
16354544|NCT00227461|Drug|Levetiracetam first, then wait|subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
16354545|NCT00227448|Drug|intravenous saline|
16354546|NCT00227448|Drug|intravenous phenylephrine|
16354547|NCT00227448|Drug|intravenous levophed|
16354548|NCT00227448|Drug|oral midodrine|
16354549|NCT00227435|Drug|val-mCyd|
16354550|NCT00227422|Biological|Mencevax ACWY|
16354551|NCT00227409|Drug|calcium disodium EDTA (edetate calcium disodium)|
16354552|NCT00227383|Device|Electroacupuncture (device)|
16354553|NCT00227370|Drug|valganciclovir|valgan 900mg QD x 9 months post lung transplant
16354554|NCT00227370|Other|Placebo|
16354555|NCT00227357|Drug|On-site - buprenorphine/naloxone (Suboxone)|Tablet, sub-lingual, 8/2 mg, 1-3 daily
16354556|NCT00227357|Drug|Off-site - methadone or no agonist|
16354557|NCT00227344|Device|RF ablation|Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
16354558|NCT00227344|Drug|Antiarrhythmic drugs|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
16354559|NCT00227331|Drug|Oral amoxicillin|
16354560|NCT00227318|Drug|ATACAND|
16354561|NCT00227305|Drug|quetiapine fumarate|Oral dosing, flexible dosing
16354562|NCT00227292|Drug|Escitalopram|Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
16354563|NCT00227292|Drug|Placebo|Placebo 10mg per day for the first week, then 20mg per day till the end of study.
16354564|NCT00227279|Biological|ALK Grass tablet|Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
16354565|NCT00227266|Drug|Valproic Acid and Levocarnitine|VPA,sprinkle cap; Levocarnitine, syrup; dosage is by weight
16354566|NCT00227266|Drug|Placebo|
16355064|NCT00223223|Drug|Levetiracetam, Keppra|
16354580|NCT00227201|Behavioral|Self-affirmation intervention|
16354581|NCT00227188|Drug|Pneumococcal 7-valent conjugate vaccine Prevnar|
16354582|NCT00227175|Behavioral|Semi-structured, open ended interview|
16354583|NCT00227162|Behavioral|Group 1|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.
16354584|NCT00227162|Behavioral|Group 2|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.
16354585|NCT00227162|Behavioral|Group 3|Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive both positive affect and self-affirmation intervention.
16354586|NCT00227136|Drug|5-Hydroxy-Tryptamine|
16354587|NCT00227123|Drug|quetiapine, risperidone|Flexible dose titrations to 'treat-to-symptoms'
16354588|NCT00227110|Drug|Pioglitazone|30 mg/d for 8 weeks and titrated to 45 mg/d until completing 6 months of treatment.
16354589|NCT00227110|Drug|Placebo|Placebo is given to match pioglitazone.
16354590|NCT00227097|Behavioral|Education Notebook for anticoagulant treatment|
16354591|NCT00227084|Drug|Arista AH hemostasis powder|
16354592|NCT00227071|Behavioral|exercise|
16354593|NCT00227058|Drug|Orotic acid and Glutathione-(Nutritional Supplements)|
16354594|NCT00227032|Drug|erlotinib hydrochloride|"300 mg, per day for subjects taking EIAEDs
~150 mg, per day for those NOT taking EIAEDs"
16354595|NCT00227019|Drug|Bevacizumab|15 mg/kg, IV over 10 minutes every 3 weeks
16354596|NCT00227019|Drug|Pemetrexed|500 mg/m²; IV over 10 minutes every 3 weeks
16354597|NCT00227019|Drug|Vitamin B12|1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed
16354598|NCT00227019|Drug|Folate|350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose
16354599|NCT00227019|Drug|Dexamethasone|4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed
16354600|NCT00227006|Behavioral|Behavioral lifestyle/weight-loss intervention|
16354601|NCT00226993|Drug|CPG 7909|
16354602|NCT00226980|Drug|Thalidomide|
16354603|NCT00226980|Drug|Capecitabine|
16354604|NCT00226967|Drug|Sandostatin|Calculated per patient
16354605|NCT00226954|Drug|zoledronic acid|
16354606|NCT00226941|Drug|Cetuximab|Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)
16354607|NCT00226941|Drug|Oxaliplatin|Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.
16354608|NCT00226941|Drug|Capecitabine|Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses
16354609|NCT00226941|Radiation|Radiotherapy|"Radiotherapy is administered on weekdays in 180 centigray fractions (doses), for 28 total fractions delivering a total dose of 5040 centigray (cGy)"
16354610|NCT00226941|Drug|Diphenhydramine hydrochloride (HCl)|Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab
16354611|NCT00226928|Behavioral|Supportive-Expressive Group Therapy plus education|
16354612|NCT00226928|Behavioral|Education|
16354613|NCT00226915|Drug|Paclitaxel+Carboplatin|Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles
16354614|NCT00226915|Drug|Paclitaxel+Carboplatin|Paclitaxel 80mg/m2 weekly ＋CBDCA AUC6 q21 days x 6-9cycles
16354615|NCT00226902|Procedure|Changing hemoglobin concentration|
16354616|NCT00226889|Drug|bosentan|
16354617|NCT00226863|Behavioral|meditation plus education|
16354618|NCT00226863|Behavioral|group psychotherapy with hypnosis plus education|
16354619|NCT00226863|Behavioral|education|
16354620|NCT00226850|Behavioral|hypnosis|
16354621|NCT00226837|Drug|Nitrous oxide|nitrous oxide by inhalation during induction
16354622|NCT00226824|Drug|galantamine|
16354623|NCT00226811|Drug|Sunitinib|50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
16354624|NCT00226798|Drug|Capecitabine (Xeloda)|
16354625|NCT00226785|Drug|Dexmedetomidine|
16354626|NCT00226772|Drug|OMS103HP|Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
16354627|NCT00226772|Drug|Vehicle|Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
16354628|NCT00226759|Drug|OMS103HP|Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.
16354629|NCT00226759|Drug|Vehicle|Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
16354630|NCT00226746|Drug|Paclitaxel and gemcitabine|"Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.
~Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36."
16354631|NCT00226733|Behavioral|Exercise training|Interval exercise training with high intensity five days per week for four weeks.
16354632|NCT00226733|Behavioral|Exercise training|Exercise training with moderate intensity, five days per week for four weeks.
16354633|NCT00226720|Procedure|Outpatient detoxification program|Outpatient detoxification program
16354634|NCT00226707|Drug|Pimecrolimus Cream 1%|
16355065|NCT00223210|Drug|Quetiapine|Active Quetiapine
16354635|NCT00226694|Drug|Citalopram|Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
16354636|NCT00226694|Other|Placebo|Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
16354637|NCT00226681|Behavioral|Nursing Telephone Support Protocol|
16354638|NCT00226681|Behavioral|Usual Care|
16354639|NCT00226668|Drug|hCRF|hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
16354640|NCT00226668|Drug|placebo hCRF|placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
16354641|NCT00226655|Drug|hCRF [XERECEPT (corticorelin acetate injection)]|2mg/day
16354642|NCT00226642|Drug|Sertralin|
16354643|NCT00226642|Behavioral|Cognitive-behavioral therapy|
16354644|NCT00226642|Drug|Placebo|
16354645|NCT00226642|Behavioral|Non-specific supporting group therapy|
16354646|NCT00226629|Procedure|Endovascular vs Open Repair|
16354647|NCT00226616|Drug|Zinc|
16354648|NCT00226603|Behavioral|Specific training programme (behavior)|
16354649|NCT00226590|Drug|Gemcitabine|Induction Chemotherapy.
16354650|NCT00226590|Drug|Carboplatin|Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
16354651|NCT00226590|Drug|Paclitaxel|Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.
16354652|NCT00226590|Procedure|Radiation|Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.
16354653|NCT00226577|Drug|Gemcitabine|Gemcitabine (GemzarR) 1500 mg/m2
16354654|NCT00226577|Drug|Pemetrexed|Pemetrexed (AlimtaR) 500 mg/m2
16354655|NCT00226577|Procedure|Surgery|When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.
16354656|NCT00226564|Drug|Alfentanil|
16354657|NCT00226551|Drug|Isoproterenol|
16354658|NCT00226538|Drug|Phenytoin|
16354659|NCT00226538|Drug|Rifampicin|
16354660|NCT00226538|Drug|Diclophenac|
16354661|NCT00226538|Drug|Fluconazole|
16354662|NCT00226525|Procedure|skin sensitivity test|
16354663|NCT00226512|Drug|Campath-1H /ATG|
16354664|NCT00226499|Biological|Priorix-tetra™|2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group
16354665|NCT00226499|Biological|Priorix™|2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group
16354666|NCT00226499|Biological|Varilrix™|1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
16354667|NCT00226486|Other|multifactorial intervention|Identification of medical, cardiovascular, physical risk factors for falls; e.g. vision, drug-use, depression, carotid sinus syndrome, orthostatic hypotension, etc. Individual intervention; treatment of disease, drug review, pacemaker, exercises, new glasses, all if indicated.
16354668|NCT00226486|Other|Usual care|No intervention, but ususal care after an accidental fall.
16354669|NCT00226473|Drug|Cisplatin, Vindesine, Dacarbazine (drugs)|
16354670|NCT00226460|Drug|Fetal porcine cells, Neurocell-PD|
16354671|NCT00226447|Drug|Pegylated Interferon|
16354672|NCT00226447|Drug|Lamivudine|
16354673|NCT00226434|Procedure|Early antiretroviral treatment|The ARV treatment is started 2 weeks after the diagnosis and the start of the anti-tuberculosis treatment
16354674|NCT00226434|Procedure|Late antiretroviral treatment|The ARV treatment is started 8 weeks after the diagnosis and the start of the anti-tuberculosis treatment
16354675|NCT00226421|Drug|Oxymorphone Extended Release|
16354676|NCT00226408|Drug|Interferon-alpha-2b|
16354677|NCT00226395|Drug|Oxymorphone immediate release|
16354678|NCT00226382|Drug|Pegylated Interferon-alfa-2a|Pegasys once weekly
16354679|NCT00226369|Drug|CY-1503|
16354680|NCT00226356|Drug|Supplements of L-methionine, betaine and folate|
16354681|NCT00226343|Drug|Depakote-ER|
16354682|NCT00226330|Drug|Tesaglitazar|(0.5 or 1 mg)
16354683|NCT00226330|Drug|Pioglitazone|(15, 30 or 45 mg)
16354684|NCT00226317|Drug|Aripiprazole|
16354685|NCT00226291|Other|Synthesized evidence report|Each consultation response included a documented bibliographic search strategy with corresponding references, a targeted list of full-text articles, and a written synthesis and critique of the relevant research materials.
16354686|NCT00226278|Drug|ORG 34517|
16354687|NCT00226252|Procedure|Instruction Only|Video details an individual propelling a manual wheelchair with biomechanically correct propulsion technique.
16354688|NCT00226252|Procedure|Instruction and Feedback|Individuals will watch video of correct propulsion technique and will receive real-time feedback from the SMART Wheel as they push their wheelchair to help optimize their propulsion technique.
16354689|NCT00226239|Drug|Docetaxel|Docetaxel 75 mg/m^2 IV over 1 hour, day 1
16354690|NCT00226239|Drug|Cisplatin|Cisplatin 75 mg/m^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
16354691|NCT00226239|Drug|Cetuximab|Cetuximab dose will be 250 mg/m^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
16354692|NCT00226239|Procedure|Radiation Therapy|Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies>6 MV may be utilized when appropriate to boost target localized centrally.
16354693|NCT00226226|Procedure|Peripherally Inserted Central Catheter Placement|
16354694|NCT00226213|Procedure|Peripherally Inserted Central Catheter Placement|
16354695|NCT00226200|Drug|Omalizumab|
16354696|NCT00226187|Procedure|Supplement of fatty acid (DHA and AA)|
16354697|NCT00226174|Drug|Curcuminoids|
16354698|NCT00226161|Procedure|Inguinal herniorrhaphy|
16354699|NCT00226148|Procedure|Use of a membrane to cover bonedefects around implant|
16355066|NCT00223210|Drug|PLacebo|Placebo
16354700|NCT00226148|Device|Use of bonechips to fill up defects around implant|
16354701|NCT00226148|Procedure|Use of membrane and bonechips to manage defects|
16354702|NCT00226135|Drug|lithium or lamotrigine|
16354703|NCT00226122|Drug|Indomethacin|Indomethacin capsules 50 mg
16354704|NCT00226109|Drug|spironolactone|100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
16354705|NCT00226096|Drug|Labetalol Hydrochloride|
16354706|NCT00226096|Drug|Metoprolol tartrate|
16354707|NCT00226096|Drug|Hydralazine Hydrochloride|
16354708|NCT00226096|Drug|Glycerol Trinitrate|
16354709|NCT00226096|Drug|Phentolamine mesylate|
16354710|NCT00226096|Drug|Nicardipine|
16354711|NCT00226096|Drug|Urapidil|
16354712|NCT00226096|Drug|Esmolol|
16354713|NCT00226096|Drug|Clonidine|
16354714|NCT00226096|Drug|Enalaprilat|
16354715|NCT00226096|Drug|Nitroprusside|
16354716|NCT00226070|Procedure|interview and advising|
16354717|NCT00226070|Behavioral|3 follow up interviews and personal advising|
16354718|NCT00226070|Procedure|interview SF-36 self rated health|
16354719|NCT00226057|Drug|Raptiva|Open Label
16354720|NCT00226044|Drug|Omeprazole rectally 1mg/kg|A single dose of 1 mg/kg rectally administered omeprazole.
16354721|NCT00226031|Procedure|Educational Material and Reminder|Family practices were randomly assigned to intervention or usual care. The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
16354722|NCT00226018|Device|Hand Adapter (Organon, Oss, the Netherlands)|Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)
16354723|NCT00226018|Device|Placebo|placebo
16354724|NCT00226005|Drug|PTK787/ZK222584|One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
16354725|NCT00225992|Drug|Arsenic Trioxide|
16354726|NCT00225979|Drug|Octreotide LAR|
16354727|NCT00225966|Device|Device Medtronic InterStim Tined Leads Models 3889 and 3093|
16354728|NCT00225927|Procedure|radioguided seed localization for nonpalpable breast cancers|radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery
16354729|NCT00225914|Drug|Paroxetine|Paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability
16354730|NCT00225914|Drug|placebo|Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.
16354731|NCT00225901|Drug|Recombinant human hepatocyte growth factor|
16354732|NCT00225888|Behavioral|Digital Photography of meals/snacks and group discussion|Digital Photography of meals/snacks and group discussion
16354733|NCT00225875|Drug|Mabthéra|
16354734|NCT00225862|Drug|ropinirole|
16354735|NCT00225849|Drug|Aspirin|
16354736|NCT00225836|Device|OVA (TENS apparatus)|
16354737|NCT00225823|Drug|GW685698X|
16354738|NCT00225810|Drug|Crohn's Disease|
16354739|NCT00225797|Drug|Oxymorphone Extended Release|
16354740|NCT00225784|Drug|Cetuximab/Gemcitabine|Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
16354741|NCT00225784|Procedure|Radiotherapy|Daily radiotherapy for 28 days
16354742|NCT00225758|Drug|Lapatinib|1500 mg po daily for 26 weeks or longer
16354743|NCT00225745|Procedure|Blood draw|One blood draw prior to first treatment
16354744|NCT00225732|Other|Normal saline as placebo comparator|250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
16354745|NCT00225732|Drug|Intravenous ibuprofen|"800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.
~Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)"
16354746|NCT00225719|Drug|rHDL|
16354747|NCT00225706|Drug|Caldolor|
16354748|NCT00225693|Device|drug eluting coronary stent|
16354749|NCT00225680|Device|drug eluting coronary stent|
16354750|NCT00225667|Drug|Irbesartan|
16354751|NCT00225654|Device|coronary stent|
16354752|NCT00225641|Procedure|CT-scan, CEA, X-ray of lungs|Arm 1: 6, 12, 18, 24 and 36 months after surgery
16354753|NCT00225641|Procedure|CT-scan, CEA, X-ray of lungs|Arm 2: 12 and 36 months after surgery
16354754|NCT00225628|Behavioral|Computerized Reminders Medications Monitoring|
16354755|NCT00225628|Behavioral|Computerized Test Results Management Application|
16354756|NCT00225628|Behavioral|Computerized Reminders Hypertension Management|
16354757|NCT00225628|Behavioral|Computerized Reminders Osteoporosis Screening and Mgt|
16354758|NCT00225615|Drug|sapropterin dihydrochloride|
16354759|NCT00225602|Behavioral|Assertive Community Treatment|
16354760|NCT00225602|Behavioral|Treatment in Community Mental Health Center|
16354761|NCT00225589|Drug|Rosuvastatin calcium|
16354762|NCT00225576|Other|Electronic Health Record Implementation|Intervention subjects implemented electronic prescribing as part of an electronic health record implementation
16354763|NCT00225563|Device|Electronic Health Record|e-prescribing methods
16354764|NCT00225550|Drug|ADH -1 (Exherin™)|
16354765|NCT00225537|Drug|4-Methylumbelliferone (Heparvit®)|
16354766|NCT00225524|Drug|Effexor XR|
16354767|NCT00225511|Drug|Effexor XR|
16354768|NCT00225511|Drug|Milnacipran|
16354769|NCT00225498|Drug|ziprasidone vs risperidone or olanzapine|ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day
16354770|NCT00225485|Drug|Effexor XR|
16354771|NCT00225472|Device|Modified Viaspan|
16354772|NCT00225446|Device|MicronTracker|MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.
16354773|NCT00225433|Drug|follitropin beta|Follitropin beta
16354774|NCT00225433|Drug|ganirelix acetate|Ganirelix acetate
16354775|NCT00225420|Drug|docetaxel|Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
16354776|NCT00225420|Drug|leuprolide acetate|Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
16354777|NCT00225420|Radiation|radiation therapy|The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.
16354778|NCT00225407|Drug|Smoking of cannabis cigarettes (different strength)|
16354779|NCT00225381|Device|connection of measuring device to anesthesia circuit|same as name
16354780|NCT00225381|Procedure|drawing of blood sample through an arterial line, placed according to clinical criteria by primary anesthesia team|same
16354781|NCT00225381|Procedure|changing operating room bed position (head down and up position)|same
16354782|NCT00225381|Procedure|adding PEEP during anesthesia|same
16354783|NCT00225381|Procedure|placement of esophageal Doppler for cardiac output measurements|same
16354784|NCT00225381|Device|Humidity sensor|Small conventional anesthesia T piece including tiny 2 thermometer inside
16354785|NCT00225381|Device|A mixing chamber (bymixer)|2 mixing chambers (bymixers) composed of 2 arms where one arm serves as a mixing (passive) arm for the measurement of mixed gas fraction. The bymixer is made of conventional anesthesia supplies and does not influence dead space nor circuit resistance.
16354786|NCT00225381|Device|Pneumotachometer cuvette|The pneumotachometer cuvette is used by many anesthesia monitors to measure gas flow.
16354787|NCT00225381|Device|Mass spectrometer sampling port|Designed for the anesthesia tubing and connected at the airway opening. it has small volume (3 mL) and do not influence circuit resistance.
16354788|NCT00225368|Device|Insecticide treated bednets|
16354789|NCT00225355|Drug|Rosiglitazone|
16354790|NCT00225342|Drug|Rosiglitazone|
16354791|NCT00225342|Drug|Gliclazide (Comparison drug)|
16354792|NCT00225329|Procedure|Labour assessment and support|
16354793|NCT00225316|Procedure|Acupuncture|See Detailed Description.
16354794|NCT00225303|Drug|TMC125|
16354795|NCT00225290|Drug|Thalidomide(Thado)|
16354796|NCT00225277|Drug|Pioglitazone|Up to 45 mg pioglitazone (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.
16354797|NCT00225277|Drug|Glimepiride|Up to 4 mg of glimepiride (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.
16354798|NCT00225264|Drug|Pioglitazone|Pioglitazone 15 mg titrated up to 45 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily for up to 72 weeks.
16354799|NCT00225264|Drug|Glimepiride|Pioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily for up to 72 weeks.
16354800|NCT00225251|Drug|bupropion XL|Antidepressant medication
16354801|NCT00225251|Other|Placebo|Placebo
16354802|NCT00225238|Drug|esomeprazole (PPI)|
16354803|NCT00225225|Drug|Rosiglitazone|
16354804|NCT00225225|Behavioral|dietary recommendation for weight maintenance|
16354805|NCT00225212|Drug|Rituximab 375 mg/m2|
16354806|NCT00225199|Drug|Visanne (BAY86-5258, SH T00660AA)|orally once daily
16354807|NCT00225199|Drug|Placebo|orally once daily
16354808|NCT00225186|Drug|Visanne (SH T00660AA , BAY86-5258)|Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
16354809|NCT00225173|Drug|Doxorubicin|Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
16354810|NCT00225173|Drug|Vinblastine|Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
16354811|NCT00225173|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
16354812|NCT00225173|Drug|Etoposide|Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
16354813|NCT00225173|Drug|Vincristine|Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
16354814|NCT00225173|Drug|Bleomycin|Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
16354815|NCT00225173|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 IV w 13,15,17,19
16354816|NCT00225173|Drug|Vinorelbine|Vinorelbine 25 mg/m2 IV w 13,15,17,19
16354817|NCT00225173|Drug|Prednisone|Prednisone 40 mg/m2 PO qod w 1-10, taper
16354818|NCT00225160|Drug|acetyl L-carnitine|
16354819|NCT00225147|Drug|Recombinant Human C1 Inhibitor|IV
16354820|NCT00225147|Drug|placebo|saline solution
16354821|NCT00225121|Drug|PF-00299804|investigational drug by oral route (escalating doses depending on safety) administered until progression
16354822|NCT00225108|Drug|Tinzaparin|
16354823|NCT00225095|Drug|Mesenchymal Stem Cells|
16354824|NCT00225095|Drug|Hyaluronan|
16354825|NCT00225082|Drug|Nucleoside analogue switch|stavudine switched to tenofovir
16354826|NCT00225069|Procedure|Level of sympathectomy|T2 sympathectomy or T2-T3 sympathectomy
16354827|NCT00225056|Drug|docetaxel and capecitabine|
16354828|NCT00225043|Drug|Epinephrine/phenylephrine|
16354829|NCT00225030|Drug|antihypertensive drugs according to current guidelines|
16354830|NCT00225017|Drug|Atazanavir|atazanavir 400 mg once daily
16354831|NCT00225017|Drug|current antiretroviral regimen|Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs
16354832|NCT00225004|Procedure|DEXA scan|orto
16354833|NCT00224991|Procedure|Intensive systematic information (osteoporosis school)|
16354834|NCT00224978|Drug|Chloroquine|
16354835|NCT00224965|Behavioral|Behavior Therapy|
16354836|NCT00224952|Other|No intervention; Urine Collection|Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management
16354837|NCT00224939|Drug|Potassium Chloride|
16354838|NCT00224926|Procedure|Scalp Brushing|sterile, soft-head toothbrush massaged on scalp
16354839|NCT00224913|Procedure|Neuromuscular electrical stimulation|
16354840|NCT00224913|Procedure|Voluntary exercise|
16354841|NCT00224887|Behavioral|In home nutrition counseling|In home family-based behavioral counseling
16354842|NCT00224887|Other|standard nutrition education curriculum|video and lesson plans based on USDA Food Guide Pyramid
16354843|NCT00224874|Drug|Etanercept|Etanercept [25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in complete response by 4 weeks].
16354844|NCT00224874|Drug|Mycophenolate Mofetil|Mycophenolate mofetil (MMF) [20 mg/kg (maximum 1 gm) orally or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks].
16354845|NCT00224874|Drug|Denileukin Diftitox|Denileukin Diftitox (ONTAK®) [9 mcg/kg intravenously Days 1, 3, 5, 15, 17, 19].
16354846|NCT00224874|Drug|Pentostatin|Pentostatin [1.5 mg/m2 daily for 3 days; Days 1-3 and repeat Days 15-17
16354847|NCT00224861|Behavioral|Self-Management|
16354848|NCT00224861|Behavioral|Adherence|
16354849|NCT00224848|Behavioral|Palm-Pilot Intervention|"Both groups received guideline dissemination, patient activation materials, continuing education (CE) and feedback based on baseline chart audit. The intervention included academic detailing (AD) and a hand-held computerized decision support tool that provided patient-specific, ATPIII-based risk stratification and treatment recommendations. CE sessions offered information relevant to ATPIII and JNC7 and focused on the evidence base. AD offerings focused on strategies to apply concepts to practice and were specific to the randomized arm. Investigators visited each practice at baseline to educate physicians about the guideline and evidence supporting prevention of CVD, and to provide training on use of the Palm tool. Visits were conducted as lunch and learn sessions. The tool was a modified version of NHLBI's PDA decision support program and indicates specific drug therapies and dosages needed to achieve cholesterol reduction and prints documentation. A user's manual was developed."
16354850|NCT00224835|Behavioral|Mindfulness Based Stress Reduction Class|Subjects randomized to this condition will attend 120 minute weekly sessions, plus a 7 hour retreat, for training in mindfulness meditation methods.
16354851|NCT00224835|Behavioral|Cardiac Education Class|"Subjects in the disease education control condition will attend 8 weekly 60 minute sessions, plus a 7 hour special experience session, all of which will provide information about CAD in a didactic format."
16354852|NCT00224822|Drug|Aripiprazole|
16354853|NCT00224809|Drug|Angiotensin-Converting Enzyme Inhibitors|
16354854|NCT00224809|Procedure|Coronary Artery Bypass Graft|
16354855|NCT00224809|Drug|Angiotensin Receptor Blockers|
16354856|NCT00224809|Drug|Spironolactone|
16354857|NCT00224809|Drug|Aspirin|
16354858|NCT00224809|Drug|Clopidogrel|
16354859|NCT00224809|Procedure|Surgical Ventricular Restoration|
16354860|NCT00224796|Device|V.A.C. ® System|
16354861|NCT00224783|Biological|CAIV-T|Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)
16354862|NCT00224783|Biological|Placebo|0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
16354863|NCT00224770|Drug|MIS+Cathflo Activase (drug)|MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.
16354864|NCT00224770|Procedure|Intraoperative stereotactic CT-Guided Endoscopic Surgery|Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.
16354865|NCT00224757|Procedure|Transoesophageal echocardiography|TEE
16354866|NCT00224744|Device|ultracision|Surgery by Ultracision
16354867|NCT00224744|Device|classical lymphadenectomy|classical lymphadenectomy
16354868|NCT00224718|Procedure|Endovascular repair (with endograft)|An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).
16354869|NCT00224718|Procedure|Open repair|Conventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.
16354870|NCT00224705|Device|Molecular Adsorbent Recirculating System (MARS®)|
16354871|NCT00224692|Drug|Low dose ketamine|
16354872|NCT00224679|Drug|Aspirin|
16354873|NCT00224666|Device|Cortex stimulation|
16354874|NCT00224653|Procedure|Mechanical Ventilation|
16354875|NCT00224640|Drug|Iron chelating intervention|Iron chelating intervention
16354876|NCT00224627|Procedure|Capsule GIVEN IMAGING LTD|
16354877|NCT00224614|Procedure|Allogenic transplantation|
16354878|NCT00224601|Procedure|Colonoscopy with chromoscopy|
16354879|NCT00224588|Drug|Ketamine (or placebo : isotonic saline solution)|
16354880|NCT00224575|Other|diagnosis reassessment|Strategy of diagnosis reassessment following a decision tree.
16354881|NCT00224575|Other|Diagnosis strategy and subsequent therapeutic reassessment|Performed by geriatricians, following a decision tree, based on medical history, electrocardiogram, cardiac echotomography and stress scintigraphy
16354882|NCT00224562|Drug|TNF-alpha antagonists|
16354883|NCT00224549|Drug|irbesartan, amlodipine and hydrochlorothiazide|irbesartan, amlodipine and hydrochlorothiazide
16354884|NCT00224536|Procedure|Intracoronary bone marrow cell transfer|
16354885|NCT00224523|Drug|GW685698X|
16354886|NCT00224523|Drug|mometasone furoate|
16354887|NCT00224510|Drug|lamotrigine|
16354888|NCT00224497|Drug|SB-742457|
16354889|NCT00224484|Biological|GSK208141|3 intramuscular doses
16354890|NCT00224484|Biological|Havrix (investigational formulation)|3 intramuscular doses
16354891|NCT00224484|Biological|Placebo|3 intramuscular doses
16354892|NCT00224471|Biological|GSK208141 vaccine|3 IM doses
16354893|NCT00224458|Drug|Truvada|
16354894|NCT00224458|Drug|efavirenz|
16354895|NCT00224445|Drug|Truvada|Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD)
16354896|NCT00224445|Drug|Atazanavir|Atazanavir 300 mg (given as two 150-mg capsules) administered orally QD
16354897|NCT00224445|Drug|Ritonavir|Ritonavir 100 mg capsule administered orally QD
16354898|NCT00224432|Drug|probiotics: Lactobacillus GG, lactobacillus Rhamnosus|
16354899|NCT00224419|Behavioral|Motivational interviewing for smoking cessation|All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day.
16354900|NCT00224419|Behavioral|Cognitive behaviors therapy|6 counseling sessions delivered over the phone or in person
16354901|NCT00224419|Drug|CBT + NRT|Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount
16354902|NCT00224406|Drug|repertaxin|
16354903|NCT00224393|Drug|Enbrel|
16354904|NCT00224380|Behavioral|Using Medications Effectively|
16354905|NCT00224367|Behavioral|time to first ambulation|
16354906|NCT00224354|Biological|IL-2 secreting and hCL4OL-expressing autologous B-CLL cells|Patients will be treated with six subcutaneous injections of their IL-2-secreting and hCD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window
16354907|NCT00224354|Biological|IL-2|subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
16354908|NCT00224354|Biological|CD40L|subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
16354909|NCT00224354|Drug|ONTAK|an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK
16354910|NCT00224354|Biological|immunotoxin dose|Days 0, 2, and 4 (18 ug/kg) i.v
16354911|NCT00280839|Drug|Topiramate|
16354912|NCT00280839|Drug|Placebo|
16354913|NCT00224341|Device|Pacemaker Vitatron Selection 9000|
16354914|NCT00224341|Device|Pacemaker Vitatron T70|
16354915|NCT00224328|Device|ODISsey Tissue Oximeter|
16354916|NCT00224315|Drug|ziprasidone|
16354917|NCT00224315|Drug|risperidone|
16354918|NCT00224302|Drug|Duloxetine|
16354919|NCT00224289|Drug|Latanoprost 0.005%|Latanoprost 0.005% ophthalmic solution QHS 8 weeks
16354920|NCT00224263|Drug|Lingzhi (Ganoderma)|
16354921|NCT00224250|Procedure|One- versus two-layer hysterotomy closure|
16354922|NCT00224211|Behavioral|Music|
16354923|NCT00224198|Procedure|Lung Disease|Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. In the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways.In the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently to obtain epithelial cells lining the airway. Certain individuals may have bronchial wall biopsy carried out. In this procedure, a small biopsy forceps is passed through the bronchoscope and a small biopsy is obtained from the bronchial wall.
16354924|NCT00224185|Procedure|Bronchopulmonary Lung Lavage|Lung Lavage is a Washing. Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways. Once the fluid has been collected, the fluid is centrifuged and the cells are collected and counted.
16354925|NCT00224185|Procedure|Bronchial Brushing|Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently (in up to 20 different sites in the large and small airways) to obtain epithelial cells lining the airway. Cells collected by airway brushing will be washed, counted, and evaluated for viability. They will also be studied for differential cell count by standard procedures. Collected airway cells will be used to carry out studies assess expression of various genes and to study viral gene transfer.
16354926|NCT00224185|Procedure|Bronchial Wall Biopsy|This is a safe and widely used investigative method in pulmonary medicine. In this procedure, a small biopsy forceps is passed through the bronchoscope and, under direct vision, a small biopsy (in up to 5 sites) is obtained from the bronchial wall. A biopsy obtains tissue to a depth of 2-3 mm, and includes epithelial and subepithelial tissue.
16354927|NCT00224159|Behavioral|Drug and Dietary behavior|
16354928|NCT00224146|Drug|oxybutynin transdermal delivery system (Oxytrol(r))|
16354929|NCT00224133|Drug|Silodosin|8 mg daily
16354930|NCT00224120|Drug|Silodosin|8 mg daily for 12 weeks
16354931|NCT00224120|Other|Placebo|One capsule daily for 12 weeks
16354932|NCT00224107|Drug|Silodosin|8 mg daily for 12 weeks
16354933|NCT00224107|Other|Placebo|1 capsule daily for 12 weeks
16354934|NCT00224094|Drug|Premarin® (oral) vs. Alora® (transdermal)|
16354935|NCT00224081|Drug|Sodium ferric gluconate,|Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
16354936|NCT00224068|Drug|Sodium ferric gluconate, ferrous sulfate, standard of care|
16354937|NCT00224055|Drug|Sodium Ferric Gluconate Complex in Sucrose Injection|Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
16354938|NCT00224055|Drug|Ferrous sulfate tablets|ferrous sulfate, 325 mg oral, three times daily for 6 weeks
16354939|NCT00224042|Drug|Sodium Ferric Gluconate complex in sucrose|Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
16354940|NCT00224042|Drug|Ferrous sulfate tablets|ferrous sulfate 325 mg three times daily for 6 weeks
16354941|NCT00224029|Drug|Oxybutynin transdermal system|3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
16354942|NCT00224016|Drug|Oxybutynin|1.3, 2.6, 3.9 mg/day transdermal
16354943|NCT00224016|Drug|Oxybutynin|5 to 15 mg/day immediate release or extended release tablets, or syrup
16354944|NCT00224003|Drug|Sodium Ferric Gluconate Complex in Sucrose.|
16354945|NCT00223990|Biological|FMP1/AS02A|FMP1/AS02A candidate malaria vaccine
16354946|NCT00223990|Biological|RabAvert|RabAvert rabies vaccine
16354947|NCT00223977|Drug|Sodium Ferric Gluconate Complex|125 mg weekly x 8 weeks
16354948|NCT00223977|Drug|Sodium Ferric Gluconate Complex|250 mg weekly x 4
16354949|NCT00223977|Drug|Oral Iron|325 mg ferrous sulfate orally three times daily x 8 weeks
16354950|NCT00223964|Drug|Ferrlecit (sodium ferric gluconate complex in sucrose injection)|
16354951|NCT00223951|Drug|R89674 (generic name not yet established)|
16354952|NCT00223938|Drug|Oral Iron|Oral Iron
16354953|NCT00223938|Drug|sodium ferric gluconate|weekly intravenous injection Dose 1
16354954|NCT00223938|Drug|sodium ferric gluconate|weekly intravenous injection Dose 2
16354955|NCT00223925|Drug|Maribavir|
16354956|NCT00223925|Drug|Placebo|
16354957|NCT00223912|Device|ERGYS BikeFunctional Electrical Stimulation Ergometry|A
16354958|NCT00223899|Genetic|VCL-IM01 (encoding IL-2) with Electroporation|IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
16354959|NCT00223873|Procedure|Penile Vibratory Stimulation|
16354960|NCT00223860|Drug|Human chorionic gonadotropin (hCG)|
16354961|NCT00223860|Drug|Luteinizing hormone releasing hormone (LHRH)|
16354962|NCT00223847|Behavioral|Constraint Induced Language Therapy|
16354963|NCT00223834|Behavioral|single session of Motivational Interviewing|
16354964|NCT00223821|Drug|Oxybutynin chloride, extended-release, individually-titrated|Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
16354965|NCT00223821|Behavioral|Behavior Training|Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
16354966|NCT00223808|Other|Robot-Low|1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
16354967|NCT00223808|Other|Robot-High|2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
16354968|NCT00223808|Other|Control|1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
16354969|NCT00223795|Device|Single point cane|Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
16354970|NCT00223782|Behavioral|Gait Training with Feedback|
16354971|NCT00223782|Behavioral|Gait Training with no feedback|
16354972|NCT00223769|Drug|Oxandrolone|
16354973|NCT00223756|Other|Low Vision Intervention - Outpatient Training Program|Patients receive LV therapy as outpatients
16354974|NCT00223743|Drug|Zonisamide|study drug initially will taken as one 50-mg tablet a day, then the dose increased by one tablet each two weeks, to no more than 3 tablets (150 mg) taken twice a day.
16354975|NCT00223730|Drug|Citrulline|Oral provision of amino acid citrulline to support impaired urea cycle function during escalated dose chemotherapy for stem cell transplant
16354976|NCT00223730|Drug|Placebo|
16354977|NCT00223717|Drug|Clonidine|0.1-0.2mg po. Single dose.
16354978|NCT00223717|Drug|Nitroglycerin transdermal|0.05-0.2 mg patch. 1 application. Alone or in combination with DDAVP.
16354979|NCT00223717|Drug|Dipyridamole/ Aspirin (Aggrenox)|dipyridamole 200 mg and aspirin 25 mg po. Single dose.
16354980|NCT00223717|Drug|Desmopressin (DDAVP)|0.2 - 0.6mg po. Single dose. Alone or in combination with nitroglycerin transdermal or nifedipine
16354981|NCT00223717|Drug|Sildenafil|25- 100 mg po. Single dose.
16354982|NCT00223717|Drug|Nifedipine|10-30 mg po. Single dose.
16354983|NCT00223717|Drug|Hydralazine|10-50 mg po. Single dose
16354984|NCT00223717|Drug|Hydrochlorothiazide|12.5-100 mg po. Single dose.
16354985|NCT00223717|Drug|Placebo|Po or patch. Single dose.
16354986|NCT00223717|Drug|Bosentan|62.5 -125 mg po. Single dose.
16354987|NCT00223717|Drug|Diltiazem|30-60 mg po. Single dose.
16354988|NCT00223717|Drug|Eplerenone|50-100 mg po. Single dose.
16354989|NCT00223717|Drug|guanfacine|1-3 mg po. Single dose.
16354990|NCT00223717|Dietary Supplement|L-arginine|6-17 g po. Single dose
16354991|NCT00223717|Drug|captopril|25-50 mg PO. Single dose.
16354992|NCT00223717|Drug|carbidopa|25-200 mg PO. Single dose.
16354993|NCT00223717|Drug|losartan|25-200 mg PO. Single dose.
16354994|NCT00223717|Drug|metoprolol tartrate|25-100 mg PO. Single dose.
16354995|NCT00223717|Drug|nebivolol hydrochloride|2.5-40 mg PO. Single dose.
16354996|NCT00223717|Drug|prazosin hydrochloride|0.5-1 mg PO. Single dose.
16354997|NCT00223717|Drug|tamsulosin hydrochloride|0.4-0.8 mg PO. Single dose.
16354998|NCT00223717|Other|Head-up tilt.|Head of the bed elevated 10 degrees (7 inch) or whole bed tilted head-up 5 degrees in reverse trendelenburg (head of the bed elevated 7 inches)
16354999|NCT00223717|Drug|aliskiren|aliskiren (Tekturna) 150-300mg po single dose
16355000|NCT00223717|Other|Local heat stress|Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso
16355001|NCT00223704|Drug|HOE 140|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
16355002|NCT00223704|Drug|Aminocaproic Acid|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
16355063|NCT00223236|Drug|Placebo|Placebo matching active medication in all other aspects.
16355003|NCT00223704|Drug|Placebo|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
16355004|NCT00223691|Drug|Atomoxetine|10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
16355005|NCT00223691|Drug|Acarbose|25-100 mg, PO. Single dose.
16355006|NCT00223691|Drug|Pyridostigmine Bromide|30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
16355007|NCT00223691|Drug|Yohimbine|2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
16355008|NCT00223691|Drug|Midodrine HCl|2.5, 5.0, 7.5, 10 mg PO. Single dose
16355009|NCT00223691|Drug|placebo|PO.Single dose.
16355010|NCT00223691|Drug|Modafinil|50-400 mg PO. Single dose
16355011|NCT00223691|Drug|Octreotide|5-50 µg, S.C. Single dose.
16355012|NCT00223691|Other|water intake|Tap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.
16355013|NCT00223691|Drug|Diphenhydramine Hydrochloride|12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine
16355014|NCT00223691|Drug|Ranitidine HCL|150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
16355015|NCT00223691|Drug|Tranylcypromine|5 - 40 mg PO. Single dose
16355016|NCT00223691|Drug|Ergotamine/ Caffeine|Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
16355017|NCT00223691|Drug|Celecoxib|50-200 mg PO. Single dose
16355018|NCT00223691|Drug|Pseudoephedrine|15, 30 or 60 mg, PO. Single dose.
16355019|NCT00223691|Drug|Methylphenidate|5 or 10 mg PO. Single dose.
16355020|NCT00223691|Drug|Indomethacin|25, 50 or 75 mg, PO. Singe dose.
16355021|NCT00223691|Drug|Ibuprofen|300, 600 or 900 mg, PO. Single dose.
16355022|NCT00223691|Drug|Oxymetazoline 0.05% nasal solution|1-2 sprays/ nostril. Single dose.
16355023|NCT00223691|Dietary Supplement|Bovril|6-10 g, PO. Single dose.
16355024|NCT00223691|Drug|Acetazolamide|125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine
16355025|NCT00223691|Drug|Rivastigmine tartrate|1.5-6 mg PO. Single dose.
16355026|NCT00223691|Drug|Carbidopa/levodopa|10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
16355027|NCT00223691|Device|Inflatable abdominal binder|External abdominal compression (20-40 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
16355028|NCT00223691|Device|inflatable abdominal binder (sham)|External abdominal compression (5 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
16355029|NCT00223678|Drug|Rapamycin|Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
16355030|NCT00223665|Drug|Flutamide|Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.
16355031|NCT00223665|Drug|Leuprolide Acetate|Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months.
16355032|NCT00223652|Behavioral|Telephone cognitive behavioral therapy|An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.
16355033|NCT00223639|Drug|Topiramate|200mg twice a day
16355034|NCT00223626|Drug|Topiramate|the maximum topiramate test dose is 200 mg/d.
16355035|NCT00223613|Drug|daily intranasal administration of insulin|
16355036|NCT00223600|Behavioral|Nutritional and life style counseling|
16355037|NCT00223587|Other|1 week of treatment discontinuation|1 week of treatment discontinuation during allergic rhinitis season
16355038|NCT00223574|Drug|Control - high carbohydrate, high glycemic index foods|
16355039|NCT00223574|Drug|high carbohydrate, low glycemic index foods|
16355040|NCT00223574|Drug|low carbohydrate, high monounsaturate fat foods|
16355041|NCT00223561|Drug|methylphenidate|
16355042|NCT00223548|Drug|sodium 2-mercaptoethane sulfonate|
16355043|NCT00223535|Behavioral|Cognitive Remediation|
16355044|NCT00223535|Behavioral|Social Skills Training|
16355045|NCT00223522|Device|MEMS caps|
16355046|NCT00223509|Drug|Lamotrigine|
16355047|NCT00223496|Drug|Aripiprazole|Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
16355048|NCT00223483|Genetic|Isolation of genomic DNA|One time blood draw
16355049|NCT00223457|Behavioral|Factors that influence compliance|
16355050|NCT00223431|Device|all-ceramic fixed partial denture|
16355051|NCT00223418|Drug|aripiprazole|
16355052|NCT00223405|Device|crown placement|
16355053|NCT00223379|Procedure|Endodontic procedure with varied apical preparation size|Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method
16355054|NCT00223353|Other|Prosthetics, Orthotics and Physical Therapy|Gait Analysis.
16355055|NCT00223340|Behavioral|Patient Activation and Diabetes Registry|
16355056|NCT00223314|Behavioral|HIV, STD, Pregnancy Prevention Curriculum|The curriculum is designed to change students' knowledge, perceptions of norms, beliefs, self-efficacy, interpersonal skills (i.e., refusal skills), and high-risk behaviors related to HIV. The curriculum included use of facilitators for selected lessons such as role playing. Intervention strategies included demonstrations of skills by role playing, use of role model stories, and other experiential learning techniques. The curriculum was delivered during the school days by facilitators (project staff) who received intensive training prior to implementation and coaching and support during implementation.
16355057|NCT00223301|Drug|Mycophenolate Mofetil (cellcept)|
16355058|NCT00223288|Drug|Lexapro|
16355059|NCT00223275|Drug|Naltrexone|
16355060|NCT00223262|Drug|Lamotrigine (Drug)|
16355061|NCT00223249|Drug|Quetiapine|
16355062|NCT00223236|Drug|Citicoline|Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.
16355068|NCT00223171|Drug|Androgen blockade + radiation therapy|Androgen blockade + radiation therapy
16355069|NCT00223158|Drug|Liothyronine|
16355070|NCT00223145|Radiation|Radiotherapy 70 Gy|Radiotherapy to the prostate
16355071|NCT00223145|Radiation|Radiotherapy 76 Gy|Radiotherapy to the prostate
16355072|NCT00223145|Drug|Androgen blockade|Duration : 6 months
16355073|NCT00223132|Device|Absorbable sutures|
16355074|NCT00223119|Device|Absorbable Sutures|
16355075|NCT00223106|Device|Vaginal Sling|
16355076|NCT00223093|Drug|TAIZ|
16355077|NCT00223080|Biological|ALVAC-HIV vCP1521 + AIDSVAX|Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
16355078|NCT00223080|Other|ALVAC Placebo + AIDSVAX Placebo|ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
16355079|NCT00223067|Drug|TAIZ|
16355080|NCT00223054|Drug|tacrolimus|retrospective analyze of drug levels in comparison to polymorphism
16355081|NCT00223054|Drug|sirolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
16355082|NCT00223054|Drug|everolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
16355083|NCT00223054|Drug|cyclosporin A|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
16355084|NCT00223041|Drug|Fluvastatin|Arm A receives fluvastatin Arm b receives no fluvastatin
16355085|NCT00223028|Drug|sirolimus, mycophenolat mofetil, fluvastatin|
16355086|NCT00223015|Drug|Fluvastatin, Tacrolimus, Mycophenolat Mofetil|
16355087|NCT00223002|Drug|Chlorhexidine|sample collected at time of procedure and then analysed for bacterial contamination
16355088|NCT00222989|Drug|PPI|
16355089|NCT00222976|Drug|Naproxen|Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
16355090|NCT00222937|Behavioral|Lessac-Madsen Resonant Voice Therapy|Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
16355091|NCT00222937|Behavioral|Casper-Based Confidential Flow Therapy|Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.
16355092|NCT00222924|Behavioral|weight loss/ exercise|
16355093|NCT00222911|Device|dorsiflexion night splint|
16355094|NCT00222911|Device|medial arch support|
16355095|NCT00222898|Procedure|DNA analysis of pancreatic cyst fluid / buccal swab|
16355096|NCT00222872|Drug|Parathyroid Hormone-related Protein|PTHrP(1-36) starting at 500 micrograms, then increasing by 125 micrograms up to a maximum of 1,500 micrograms.
16355097|NCT00222872|Drug|Placebo|Placebo drug via subcutaneous injection in single blinded fashion daily for 3 weeks
16355098|NCT00222846|Behavioral|Attention control|Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.
16355099|NCT00222846|Behavioral|Intervention|Behavioral intervention of diabetes self-management paired with PDA-based monitoring of dietary intake and physical activity. Participants also receive a pedometer and glucose self-monitoring supplies.
16355100|NCT00222833|Drug|Aripiprazole|
16355101|NCT00222820|Drug|escitalopram|
16355102|NCT00222820|Behavioral|Interpersonal Psychotherapy|
16355103|NCT00222794|Drug|Atomoxetine (Strattera)|
16355104|NCT00222755|Behavioral|Disease Management|Self-management, care management, guidelines
16355105|NCT00222742|Procedure|induced moderate hypothermia|Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.
16355106|NCT00222729|Drug|Pemetrexed|500 mg/m2 day 1 q 21 days
16355107|NCT00222729|Drug|Bevacizumab|15 mg/kg IV q 21 days following pemetrexed
16355108|NCT00222716|Behavioral|Problem solving counseling|Telephone nurse counseling behavioral intervention focused on problem solving.
16355109|NCT00222703|Behavioral|Smoking relapse prevention|
16355110|NCT00222677|Drug|aspirin|100 mg daily
16355111|NCT00222664|Biological|Hep-V Vax|
16355112|NCT00222651|Drug|tenecteplase|
16355113|NCT00222638|Drug|Influenza vaccination|
16355114|NCT00222625|Drug|rFVIIa + (vit K in AO patients)|
16355115|NCT00222625|Drug|FFP or aPCC+ vit K in AO treated patients|
16355116|NCT00222612|Other|Reduced intensification|Deletion of one 7 week treatment block containing dexamethasone, vincristine, doxorubicin, Peg-asparaginase, intrathecal methotrexate, cyclophosphamide, cytarabine.
16355117|NCT00222612|Drug|Standard childhood UK ALL protocol|No additional treatment to standard protocol.
16355118|NCT00222612|Drug|Intensified treatment including Capizzi maintenance|Augmented consolidation: vincristine, Peg-asparaginase. Capizzi maintenance: iv methotrexate and peg-asparaginase
16355119|NCT00222573|Drug|clopidogrel and metoprolol|
16355120|NCT00222560|Behavioral|Intensive physical activity counselling by an integrated physical activity counsellor|
16355121|NCT00222547|Drug|Vitamin A|
16355122|NCT00222547|Drug|Albendazole|
16355123|NCT00222534|Drug|Acetazolamide|
16355124|NCT00222534|Drug|Placebo|
16355125|NCT00222521|Drug|Glargine insulin|
16355126|NCT00222495|Drug|quetiapine|
16355127|NCT00222495|Drug|olanzapine|
16355128|NCT00222495|Drug|risperidone|
16355129|NCT00222482|Drug|Depakote ER|
16355130|NCT00222469|Drug|bevacizumab|10mg/kg IV on Day 1 Q 2 weeks
16355131|NCT00222469|Drug|gemcitabine|1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
16355132|NCT00222469|Drug|oxaliplatin|100mg/m2 on Day 2 and Q 2 weeks.
16355133|NCT00222456|Behavioral|Sensitizing parents|
16355134|NCT00222443|Drug|Irinotecan|
16355135|NCT00222430|Procedure|Fluoroscopy|Use of fluoroscopy during arterial insertion of coronary catheter
16355136|NCT00222430|Procedure|Active Comparator|Standard coronary angiography technique; no fluoroscopic assistance
16355137|NCT00222417|Procedure|myringoplasty|Myringoplasty is an operative procedure to close tympanic membrane perforations.
16355138|NCT00222417|Procedure|Stapes surgery|Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis
16355139|NCT00222365|Drug|Arnica montana, 5 CH|
16355140|NCT00222365|Drug|Bryonia alba, 5 CH|
16355141|NCT00222365|Drug|Hypericum perforatum, 5 CH|
16355142|NCT00222365|Drug|Ruta graveolens, 3 DH|
16355143|NCT00222352|Diagnostic Test|Point of Care cTnL testing|"The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test.
~The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half."
16355144|NCT00222339|Behavioral|task-specific training|
16355145|NCT00222326|Behavioral|Pelvic floor muscle training and lifestyle modification|
16355146|NCT00222300|Behavioral|Strength training program|
16355147|NCT00222287|Behavioral|Feldenkrais Movement class|
16355148|NCT00222274|Behavioral|RSA Biofeedback|RSA Biofeedback Condition. The biofeedback will consist of 10 weekly sessions of training, at the same time of day for each subject. The details of the procedure for RSA biofeedback are described in Appendix A. One single practitioner, a certified biofeedback technician, will provide the biofeedback following the aforementioned protocol. In each session, 20 minutes of biofeedback will be delivered using a J&J C-2+ Physiograph. The participant will be taught to breathe at her resonant frequency, as a first step to training the individual how to produce maximal increases in amplitude of RSA.
16355149|NCT00222274|Behavioral|EEG Biofeedback Condition|EEG Biofeedback Condition. Participants assigned to this condition will receive 10 sessions of EEG alpha biofeedback. In each session, 20 minutes of biofeedback will be delivered using a J&J I-330-C2+ physiograph. The participant will learn how to modify specific brainwave activity known as alpha. In particular, participants will be taught to increase amplitude of alpha in the range of 8-12 Hz. Increased amplitude is this range is associated with relaxation and reduction of anxiety, but not baroreflex gain. Participants will also practice for two 20-minute periods daily using the same methods used to increase alpha found in lab sessions.
16355150|NCT00222261|Drug|aspirin|Aspirin 160 mg once daily for two years
16355151|NCT00222261|Drug|clopidogrel|clopidogrel 75 mg once daily for two years
16355152|NCT00222248|Behavioral|Pelvic floor muscle training and bladder training|
16355153|NCT00222235|Drug|d-cycloserine|
16355154|NCT00222235|Drug|glycine|
16355155|NCT00222235|Drug|placebo|
16355156|NCT00222222|Procedure|vein puncture|comparison of different inflammatory markers in the blood of septic patients
16355157|NCT00222209|Behavioral|Experimental heat pain model|
16355158|NCT00222196|Procedure|lifestyle, PTA|
16355159|NCT00222183|Drug|Elidel (pimecrolimus)|
16355160|NCT00222170|Drug|Rabeprazole|
16355161|NCT00222144|Drug|Gleevec and Taxotere|Gleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15
16355162|NCT00222131|Drug|Esomeprazole|Esomeprazole 40 mg QD
16355163|NCT00222131|Other|Placebo|Placebo
16355164|NCT00222118|Behavioral|labor/birth preparation classes|prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks
16355165|NCT00222118|Other|intervention|prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum
16355166|NCT00222118|Other|usual care|no intervention
16355167|NCT00222105|Drug|Doxil|Doxil 40 mg/m2 IV day 1
16355168|NCT00222105|Drug|Thalidomide|50-100 mg day 1-28
16355169|NCT00222105|Drug|Dexamethasone|Dexamethasone 40 mg day 1-4 and 15-18
16355170|NCT00222079|Drug|Esomeprazole (Nexium)|
16355171|NCT00222066|Procedure|Fetal ovarian cyst aspiration|Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
16355172|NCT00222053|Drug|Thalidomide|Per os thalidomide
16355173|NCT00222053|Drug|Biphosphonates|Biphosphonates
16355174|NCT00222040|Radiation|Ultrasound|2-MHz, low intensity transcranial ultrasound
16355175|NCT00222040|Drug|Levovist|D-Galactose and palmitic palmitique intravenous 4 g
16355176|NCT00222027|Procedure|Collection of treatment-stratefying prognostic factors|
16355177|NCT00222014|Procedure|TIPS|Transjugular intrahepatic portosystemic shunt with covered PTFE
16355178|NCT00222014|Procedure|Paracenthese|Paracenthese
16355179|NCT00221988|Drug|Levetiracetam (Keppra)|
16355180|NCT00221975|Drug|Divalproex|Once a therapeutic blood level of lithium was achieved, Divalproex was initiated at 250 mg twice daily and increased slowly over 5 weeks to a minimum blood level of 50 μg/mL.
16355181|NCT00221975|Drug|Lamotrigine|Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over 3 weeks to a minimum blood level of 0.5 mEqlL.
16355182|NCT00221975|Drug|Lithium|Subjects who did not respond to the combination of Lithium and Divalproex were then randomly assigned in a 1:1 ratio to adjunctive lamotrigine versus placebo after stratification by illness type (bipolar I versus bipolar II), historical response to lithium (response versus oon-response), and the length of current exposure to the combination treatment with lithium and divalproex (<2 months versus ≥2 months).
16355183|NCT00221962|Drug|Aripiprazole|Open label
16355184|NCT00221949|Device|Ultrasound|
16355185|NCT00221936|Behavioral|Self-administration or nurse administered medication|
16355186|NCT00221910|Procedure|Ultrasound|
16355187|NCT00221884|Procedure|Ultrasound|
16355188|NCT00221871|Drug|Different dosages of Ketamine|
16355189|NCT00221858|Procedure|Ultrasound guided blocks|
16355190|NCT00221845|Drug|ACE Inhibition|ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
16355191|NCT00221845|Drug|Intensified Blood Pressure Control|Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.
16355192|NCT00221845|Drug|Add-on Angiotensin Receptor Blockade|In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.
16355193|NCT00221819|Device|heated humidifier (device)|
16355194|NCT00221819|Device|Heat and moisture exchanger (device)|
16355195|NCT00221806|Device|endothelialised prosthesis|
16355310|NCT00220675|Drug|Erythropoietin infusion|
16355196|NCT00221793|Procedure|Deep brain stimulation|Brain Stimulation of the Subthalamic Nucleus
16355197|NCT00221780|Device|left ventricular pacing|
16355198|NCT00221767|Device|Brindley technique (bladder system)|Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
16355199|NCT00221754|Drug|Pravastatin (drug)|
16355200|NCT00221741|Drug|Fresh Frozen Plasma (blood product)|
16355201|NCT00221728|Device|Radiofrequency|
16355202|NCT00221728|Procedure|conservative surgery|
16355203|NCT00221715|Device|femoropopliteal artery bypass|Bypass by autologous saphenous vein
16355204|NCT00221715|Device|femoropopliteal artery bypass|bypass by dacron or PTFE Prosthesis
16355205|NCT00221702|Drug|PegIntron|100 mcg SC/week for 36 months
16355206|NCT00221702|Drug|intron A|3mui TIWW SC for 18 months
16355207|NCT00221689|Drug|baclofen (drug)|
16355208|NCT00221676|Biological|Alfarix|
16355209|NCT00221663|Device|surgery techniques (sternotomy for aortic valve replacement)|
16355210|NCT00221650|Drug|Peginterferon alfa2a|
16355211|NCT00221650|Drug|Ribavirin|
16355212|NCT00221637|Drug|Sodium Valproate|
16355213|NCT00221624|Drug|Peginterferon alfa-2a|
16355214|NCT00221624|Drug|ribavirin|
16355215|NCT00221624|Drug|amantadine|
16355216|NCT00221611|Drug|Administration of intrathecal baclofen|
16355217|NCT00221598|Procedure|Haemodialysis with different dialysate temperatures|Haemodialysis with different dialysate temperatures is used.
16355218|NCT00221585|Behavioral|Psychosocial treatment/Psychodynamic treatment|
16355219|NCT00221572|Procedure|Determination of bot density of Cystic Fibrosis patients|Determination of bot density of Cystic Fibrosis patients.
16355220|NCT00221559|Procedure|Blood sampling for determination of serum Zn|
16355221|NCT00221546|Drug|Giving DHA-rich supplement|Giving DHA-rich supplement to patients.
16355222|NCT00221520|Drug|midazolam with 2 different levels of sedation scores|
16355223|NCT00221507|Behavioral|Reminder-Recall-Outreach|
16355224|NCT00221507|Behavioral|Case Management|
16355225|NCT00221507|Behavioral|Patient Navigator|
16355226|NCT00221494|Drug|citalopram + tiodothyronine, or + pindolol, or + placebo|
16355227|NCT00221481|Drug|divalproex or olanzapine|
16355228|NCT00221468|Drug|quetiapine|100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks).
16355229|NCT00221455|Behavioral|Patient diabetic self-management using the diabetic patient portal tools|
16355230|NCT00221455|Behavioral|A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.|
16355231|NCT00221442|Drug|Zonegran|zonegran (zonisamide)
16355232|NCT00221442|Drug|sugar pill|fake pill
16355233|NCT00221429|Drug|lithium sodium divalproex|
16355234|NCT00221416|Drug|Aripiprazole|5-20 mg/day
16355235|NCT00221403|Drug|Risperidone oral solution|liquid, BID dosing.
16355236|NCT00221403|Drug|Valproate Oral Solution|liquid, BID dosing.
16355237|NCT00221403|Other|Placebo|liquid, BID dosing.
16355238|NCT00221390|Drug|Ropinirole (+ physical therapy)|
16355239|NCT00221390|Drug|(vs.) Placebo + physical therapy|
16355240|NCT00221377|Device|Intubation using tracheal tubes with or without cuff|
16355241|NCT00221364|Drug|Mass treatment with oral azithromycin to an entire village|
16355242|NCT00221351|Procedure|CRP point of care testing|
16355243|NCT00221338|Drug|Gabapentin|This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
16355244|NCT00221325|Drug|Intraventricular Rituximab Plus MTX|"Intraventricular injection of rituximab into an Ommaya reservoir on day 1 of each week. Intraventricular rituximab plus methotrexate (MTX) on day 4 of each week.
~First three patients at dose A : 25 mg rituximab on day 1, and MTX (12 mg) plus rituximab (10 mg) on day 4 each week.
~If there are no dose limiting toxicities at Dose A in all of the first 3 patients or in 5 of the first 6 patients, the next 3 patients will receive dose level B: 25 mg rituximab on day 1, and combination MTX (12 mg) plus rituximab (25 mg) on day 4 of each week.
~Oral leucovorin rescue 24 hours after each MTX administration. Maximum injections will be 16 over 9-weeks. Subjects who experience a partial response at week 10 will be given the option for extended dosing."
16355245|NCT00221312|Drug|Fosamax|
16355246|NCT00221299|Drug|Risedronate|One 35mg tab of risedronate/placebo taken once a week for one year.
16355247|NCT00221299|Drug|Parathyroid Hormone|This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
16355248|NCT00221286|Drug|pegylated interferon alfa-2a|
16355249|NCT00221286|Drug|tenofovir DF / emtricitabine combination therapy|
16355250|NCT00221286|Drug|pegIFN / TDF / FTC combination therapy|
16355251|NCT00221273|Procedure|ACL surgery|
16355252|NCT00221260|Procedure|anesthesia|Intraoperative general anesthesia AND postoperative IV narcotic analgesia.
16355253|NCT00221247|Procedure|Acupuncture|acupuncture
16355254|NCT00221234|Behavioral|Print materials, pedometers/logbooks|
16355255|NCT00221234|Behavioral|Print materials, pedometers/logbooks, telephone counselling|
16355256|NCT00221221|Device|Pedometer|
16355257|NCT00221221|Device|Exercise guidebook|
16355258|NCT00221208|Behavioral|Resistance Training|
16355259|NCT00221195|Drug|activated prothrombin complex concentrate (FEIBA)|"FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months
~FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months"
16355260|NCT00221182|Genetic|Autologous peripheral blood CD34 positive cell therapy|
16355261|NCT00221169|Procedure|Surgical resection|pet ct prior to surgery
16355262|NCT00221156|Drug|Acarbose|
16355263|NCT00221143|Genetic|Autologous peripheral blood CD34 positive cell therapy|
16355264|NCT00221130|Procedure|surgical operation of cell transplantation|
16355311|NCT00220662|Behavioral|Readiness and Motivation Therapy|
16355265|NCT00221117|Device|Neuroprosthesis-FES Therapy|The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia a flexible device designed to improve grasping function in both SCI and stroke patients.This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp , and holds a number of advantages over the other existing neuroprostheses.
16355266|NCT00221117|Other|Conventional Ocupational Therapy (COT)|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
16355267|NCT00221104|Drug|Pravastatin|
16355268|NCT00221091|Procedure|ventriculo-peritoneal shunt|
16355269|NCT00221078|Device|Neuroprosthesis|The Compex Motion neuroprosthesis, developed by Drs.R. Popovic and Thierry Keller, and company Compex SA, is a flexible device designed to improve grasping function in both SCI and stroke patients. This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp, and holds a number of advantages over the other existing neuroprostesis.
16355270|NCT00221065|Device|Nasal Continuous positive airway pressure - Tyco 420G|CPAP at determined pressure nightly for 1 month
16355271|NCT00221052|Drug|Diclofenac|
16355272|NCT00221039|Drug|Methoxsalen+ECP|UVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months
16355273|NCT00221026|Drug|Methoxsalen +ECP|ECP + Uvadex given at weeks 1-12 weeks.
16355274|NCT00221026|Procedure|Extracorporeal Photopheresis|ECP given at weeks 1 through 12.
16355275|NCT00221013|Procedure|"augmented CRRT regimen"|We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.
16355276|NCT00221000|Drug|Methoxsalen|
16355277|NCT00221000|Procedure|Extracorporeal Photopheresis|
16355278|NCT00220987|Other|Intensive Insulin Therapy|Maintain blood glucose 4.5 - 6.o mmol/L
16355279|NCT00220987|Other|Conventional Insulin therapy|Maintain blood glucose 8-10mmol/L
16355280|NCT00220974|Behavioral|Internet-based tailored advice on cardiovascular risk|
16355281|NCT00220961|Drug|Pioglitazone|Pioglitazone tablets - 45 mg/day
16355282|NCT00220961|Drug|Placebo|Placebo tablets similar to pioglitazone tablets - 1 tablet/day
16355283|NCT00220948|Procedure|CERSR Myoelectric monitoring during standardized tasks|
16355284|NCT00220935|Device|Orthotrac Pneumatic Vest|
16355285|NCT00220922|Procedure|Alcohol Wipes vs. No Alcohol Wipes|
16355286|NCT00220909|Drug|Lansoprazole|
16355287|NCT00220896|Drug|Donepezil|
16355288|NCT00220870|Behavioral|Decision aid|
16355289|NCT00220857|Drug|Rabeprazole|
16355290|NCT00220844|Drug|Desipramine|
16355291|NCT00220844|Drug|Amitriptyline|
16355292|NCT00220831|Drug|Natural source Vitamin E 400IU/day|
16355293|NCT00220818|Drug|Lansoprazole|Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
16355294|NCT00220818|Drug|Lansoprazole|Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
16355295|NCT00220805|Drug|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified|The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h.
16355296|NCT00220805|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.
16355297|NCT00220792|Behavioral|Brief supportive-expressive group therapy|
16355298|NCT00220779|Drug|Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified|
16355299|NCT00220779|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|
16355300|NCT00220766|Drug|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified|
16355301|NCT00220766|Drug|Dextrose, 5% in Water|
16355302|NCT00220753|Device|IQAir Allergen 100 Air cleaners|Two air cleaners are installed in the patient's room, one in his bedroom, and one in the living room. The cleaners can be run at 5 different speeds: Speed 1 filtrates 60m3 of air per hour, speed 2 filtrates 90 m3 per hour, speed 3 filtrates 130 m3 per hour, speed 4 filtrates 240 m3 per hour, and speed 5 filtrates 380 m3 per hour. A timer-on period can be pre-set for every day of the week, but the cleaner can be run even in the timer-off period, at a speed pre-set and different from the timer-on period. Different timer-on off periods cannot be selected for different days, but the different days of the week can be pre-set to apply timer-on periods or not.
16355303|NCT00220740|Drug|Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified|2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
16355304|NCT00220740|Drug|Albumin (Human) 25%, United States Pharmacopeia (USP)|Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
16355305|NCT00220727|Drug|Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified|IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
16355306|NCT00220714|Drug|atypical antipsychotics:oral vs. long-acting route|
16355307|NCT00220714|Behavioral|Family Psychoeducation|
16355308|NCT00220701|Drug|Lexapro (escitalopram)|antidepressant drug selective serotonin reuptake inhibitor (SSRI)
16355309|NCT00220688|Device|Acupressure Wristbands|
16355312|NCT00220649|Drug|gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin|
16355313|NCT00220636|Drug|Aripiprazole|Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
16355314|NCT00220623|Drug|antidepressant medications, flexible drug choice|
16355315|NCT00220623|Behavioral|CBT, Psychodynamic or Supportive Psychotherapy|
16355316|NCT00220610|Device|Transcranial magnetic stimulation|
16355317|NCT00220597|Behavioral|Trauma-focused group therapy|
16355318|NCT00220584|Drug|donepezil|donepezil 5 mg daily for 3 weeks (days 1-21); 10 mg daily for 3 weeks (days 22-42)
16355319|NCT00220571|Device|Coronary Angioplasty (PTCA)|
16355320|NCT00220558|Device|Coronary placement of bare metal stent vs. drug eluting stent|
16355321|NCT00220545|Procedure|Laparoscopic ovarian diathermy|
16355322|NCT00220532|Drug|Folic acid with riboflavin|
16355323|NCT00220519|Drug|Lactobacillus GG|
16355324|NCT00220506|Drug|Provigil|
16355325|NCT00220493|Drug|Ritalin|
16355326|NCT00220480|Drug|escitalopram|10 to 30 mg / day
16355327|NCT00220467|Behavioral|Aerobic exercise|
16355328|NCT00220454|Drug|Climara|
16355329|NCT00220454|Drug|Hydrocortone|
16355330|NCT00220441|Behavioral|Aerobic exercise|
16355331|NCT00220428|Biological|T-Cell Vaccination|
16355332|NCT00220415|Drug|SPM 927|
16355333|NCT00220402|Drug|SPM 907|
16355334|NCT00220389|Drug|SPM 907|
16355335|NCT00220376|Drug|SPM 907|
16355336|NCT00220363|Drug|SPM 907|
16355337|NCT00220350|Drug|leuprolide acetate|
16355338|NCT00220337|Drug|lacosamide|Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
16355339|NCT00220324|Drug|Minisiston (SH D00342A)|Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval
16355340|NCT00220311|Drug|Fludarabine Phosphate (Fludara)|6 cycles (1 cycle: 5 treatment days every 28 days)
16355341|NCT00220298|Drug|Testosterone undecanoate (TU) - NebidoTM|Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
16355342|NCT00220285|Drug|Zevalin (SH L 749 , BAY86-5128)|0,3mCi/kg
16355343|NCT00220285|Drug|Zevalin (SH L 749 , BAY86-5128)|0,4mCi/kg
16355344|NCT00220272|Drug|SR57667B|
16355345|NCT00220259|Drug|Fluticasone or placebo|
16355346|NCT00220233|Drug|olmesartan medoxomil|
16355347|NCT00220233|Drug|amlodipine|
16355348|NCT00220233|Drug|hydrochlorothiazide|
16355349|NCT00220220|Drug|olmesartan medoxomil|
16355350|NCT00220220|Drug|amlodipine|
16355351|NCT00220207|Behavioral|Internet co-management module|
16355352|NCT00220194|Drug|leuprolide acetate|
16355353|NCT00220168|Drug|Irinotecan, Capecitabine|
16355354|NCT00220155|Drug|Gemcitabine|
16355355|NCT00220129|Drug|Epirubicin, Cisplatin, Capecitabine|
16355356|NCT00220129|Procedure|Surgical Resection|
16355357|NCT00220116|Drug|Capecitabine, Oxaliplatin|
16355358|NCT00220103|Drug|epirubicin, capecitabine, cisplatin|
16355359|NCT00220103|Procedure|Surgical resection|
16355360|NCT00220090|Drug|dexloxiglumide|
16355361|NCT00220077|Procedure|Endoscopy|
16355362|NCT00220064|Drug|Irinotecan, 5-Fluorouracil, Leucovorin|
16355363|NCT00220051|Drug|Oxaliplatin, Capecitabine|
16355364|NCT00220051|Procedure|Pre operative radiotherapy|
16355365|NCT00220051|Procedure|Surgical Resection|
16355366|NCT00220038|Behavioral|smell tests|subjects are instructed to sniff two vials, one containing the solvent, the other a dilution of the odorant. They are asked to scan the vial with the stronger odor.
16355367|NCT00220025|Device|Phototherapy|The patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy.
16355368|NCT00220012|Procedure|Folate depletion and supplementation|
16355369|NCT00219986|Drug|Potent HAART during acute or early HIV-1 infection|
16355370|NCT00219973|Drug|Bemiparin|Bemiparin 3.500 IU/day for 28 days compared to 8 days
16355371|NCT00219960|Drug|North American Ginseng (Panax Quinquefolius)|
16355372|NCT00219947|Other|blood draw|"T cell subset enumeration
~Serologic reactivity with HIV antigens
~Viral load assays by bDNA, PCR, or RT-PCR
~Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
~HIV-1 Resistance Testing"
16355373|NCT00219934|Drug|Antiretroviral therapy|HAART therapy
16355374|NCT00219921|Drug|Intrathecal morphine at surgery, 0.1mg and placebo|
16355375|NCT00219921|Drug|Patient Controlled Analgesia with iv morphine and placebo|
16355376|NCT00219921|Drug|intrathecal morphine AND patient controlled analgesia with iv morphine|
16355377|NCT00219908|Drug|Mitoxantrone|
16355378|NCT00219895|Drug|Ibuprofen|
16355379|NCT00219882|Drug|standardized turmeric root extract|1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days
16355380|NCT00219869|Drug|Galantamine|
16355381|NCT00219856|Drug|Propofol|"Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml
~Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml"
16355382|NCT00219856|Drug|Penthotal|Intravenous penthotal at the dose of 3 to 5 mg/kg
16355383|NCT00219856|Drug|Desflurane|Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
16355384|NCT00219843|Drug|PV-10 (rose bengal disodium, 10%)|
16355385|NCT00219830|Behavioral|home-based walking program|Home-based walking program; included use of pedometer and daily walk diary
16355386|NCT00219817|Drug|RC-1291 HCl|
16355387|NCT00219804|Drug|tetrabenazine or placebo|
16355388|NCT00219791|Drug|glucarpidase (50 Units/kg)|
16355389|NCT00219778|Drug|mifepristone|
16355390|NCT00219765|Drug|Imatinib mesylate 600 mg|
16355391|NCT00219765|Drug|Cytarabine|
16355392|NCT00219765|Drug|Daunorubicine|
16355393|NCT00219752|Drug|Imatinib mesylate 400 mg|
16355394|NCT00219739|Drug|Imatinib mesylate 400 mg|
16355395|NCT00219739|Drug|Imatinib mesylate 600 mg|
16355396|NCT00219739|Drug|Imatinib 400 mg + Peg-Interferon|
16355397|NCT00219739|Drug|Imatinib mesylate 400 mg + Cytarabine|
16355398|NCT00219726|Drug|Imatinib mesylate|
16355399|NCT00219713|Drug|nitrous oxide and oxygen|
16355400|NCT00219700|Drug|Ibuprofen-PC|
16355401|NCT00219687|Other|dispatcher-assisted CPR with compressions & ventilations|Delivery of telephone CPR instructions to lay callers with chest compressions and ventilations when the patient is identified to be in cardiac arrest
16355402|NCT00219687|Other|dispatcher-assisted CPR instructions with compressions only|Delivery of telephone CPR instructions to lay callers with hands-only chest compressions when the patient is identified to be in cardiac arrest
16355403|NCT00219674|Behavioral|Group I: Video training|"Participants will receive the AED with a video that provides instructional training."
16355404|NCT00219674|Behavioral|Group II: Video training + enhanced self-efficacy (SE)|Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.
16355405|NCT00219674|Behavioral|Group III: In-person training + enhanced SE|Participants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials.
16355406|NCT00219674|Behavioral|Group IV: In-person training + enhanced SE + support|Participants will receive a face-to-face training session in their home as well as the AED, instructional video, manikin, and a resource manual with information to enhance the family member's confidence in their role as care provider.
16355407|NCT00219661|Procedure|drainage of subglottic secretions (HiLo Evac tube)|
16355408|NCT00219648|Drug|PEP03|
16355409|NCT00219635|Drug|UK-390,957|
16355410|NCT00219622|Drug|tofimilast|
16355411|NCT00219609|Drug|UK-390,957|
16355412|NCT00219596|Drug|Xalacom|
16355413|NCT00219596|Drug|unfixed Latanoprost and Timolol|
16355414|NCT00219583|Drug|UK-390,957|
16355415|NCT00219570|Drug|clindamycin|
16355416|NCT00219570|Drug|nadifloxacin|
16355417|NCT00219557|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
16355418|NCT00219557|Drug|AG-013736|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
16355419|NCT00219557|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
16355420|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 150mg/day (75mg BID)
16355421|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 300 mg/day (150mg BID)
16355422|NCT00219544|Drug|Pregabalin (Lyrica)|pregabalin 600/day (300mg BID)
16355423|NCT00219544|Drug|Placebo|Placebo
16355424|NCT00219531|Behavioral|perception of rectal balloon distention|functional Magnetic Resonance Imaging (fMRI) study with measurement of brain MRI response to rectal balloon distention.
16355425|NCT00219518|Procedure|defecography|insertion of catheter to record pressure. Insertion of barium to outline rectum and fluoroscopy to define change in rectal contour and expulsion of barium during the study.
16355426|NCT00219505|Procedure|acupuncture|
16355427|NCT00219479|Drug|Phenytoin (Dilantin) levels during change in enteral feeding|
16355428|NCT00219466|Other|Zinc Oxide Diaper Rash Ointment|Desitin Original at diaper change
16355429|NCT00219466|Other|Aloe Vera/Tocopherol/Zinc Oxide Cream|Desitin Creamy at diaper change
16355430|NCT00219453|Device|Jet Injector with Protector Cap (HSI-500)|
16355431|NCT00219440|Other|Actos plus standard diet|Actos plus standard diet
16355432|NCT00219440|Other|Actos plus structured diet|Actos plus structured diet
16355433|NCT00219440|Other|Metformin plus standard diet|Metformin plus standard diet
16355434|NCT00219414|Device|Adacolumn Apheresis System|
16355435|NCT00219401|Biological|Pneumococcal 7 valent conjugate vaccine (Prevenar®)|Accelerated PCV vaccinaton.
16355436|NCT00219388|Drug|Levosimendan|
16355437|NCT00219375|Drug|Sivelestat sodium hydrate|0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
16355438|NCT00219375|Drug|Sivelestat sodium hydrate|0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
16355439|NCT00219362|Biological|one injection of vCP1452 at W0, W4, W8 and W20|
16355440|NCT00219362|Biological|one injection of vCP1452 at W4, W8 and W20|
16355441|NCT00219362|Biological|one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20|
16355442|NCT00219349|Behavioral|Cognitive Behavioral Therapy|14 weekly sessions of individualized CBT
16355443|NCT00219349|Drug|escitalopram|10-20 mg per day for 12 weeks
16355444|NCT00219336|Behavioral|Self-guided Motivational Intervention|Using a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS.
16355445|NCT00219336|Behavioral|Informational Only|Using a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS
16355446|NCT00219323|Drug|Omalizumab|
16355447|NCT00219310|Drug|Famciclovir|
16355448|NCT00219297|Drug|Patupilone|
16355449|NCT00219284|Drug|Carbidopa/levodopa/entacapone|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
16355450|NCT00219271|Drug|Zoledronic acid|
16355451|NCT00219258|Drug|Zoledronic acid|
16355452|NCT00219245|Drug|Rivastigmine|
16355453|NCT00219232|Drug|Rivastigmine Transdermal Patch|
16355459|NCT00219141|Drug|Aliskiren 150/300 mg|Aliskiren 150 mg tablets
16355460|NCT00219141|Drug|Losartan 50/100 mg|Losartan 50 or 100 mg capsules
16355461|NCT00219141|Drug|Aliskiren placebo|Aliskiren 150 mg placebo tablet
16355462|NCT00219141|Drug|Losartan 50/100 mg placebo|Losartan 50/100 mg placebo capsules
16355463|NCT00219128|Drug|aliskiren|
16355464|NCT00219115|Drug|aliskiren|
16355465|NCT00219102|Drug|aliskiren|
16355466|NCT00219089|Drug|aliskiren|
16355467|NCT00219076|Drug|aliskiren|
16355468|NCT00219063|Drug|aliskiren|
16355469|NCT00219050|Drug|aliskiren|
16355470|NCT00219037|Drug|aliskiren|
16355471|NCT00219024|Drug|aliskiren|
16355472|NCT00219011|Drug|aliskiren|
16355473|NCT00218998|Behavioral|exercise training|
16355474|NCT00218985|Behavioral|Exercise training|Intensity controlled exercise training before the scheduled bypass surgery
16355475|NCT00218972|Behavioral|Aerobic interval training|
16355476|NCT00218972|Behavioral|moderate intensity training|
16355477|NCT00218972|Behavioral|Recommendation of regular exercise|
16355478|NCT00218959|Behavioral|Narrative Exposure Therapy|Exposure based treatment for PTSD developed especially for refugees. Built upon Prolonged exposure treatment (Edna Foa) and Testimonial Therapy (Cientifuegos & Monelli).
16355479|NCT00218959|Behavioral|treatment as usual|
16355480|NCT00218946|Drug|Sucrose|30 % sucrose
16355481|NCT00218946|Device|Pacifier|
16355482|NCT00218946|Other|sterile water|
16355483|NCT00218933|Behavioral|Moderate intensity exercise training|12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate)
16355484|NCT00218933|Behavioral|High intensity exercise training|12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate)
16355485|NCT00218920|Behavioral|Strength training|a strength training regime of 4 series with 5 repetitions each, at approximately 90% of 1 repetition maximum (RM), in a leg press apparatus to develop maximal strength mainly from neural adaptation with minimal weight gain due to muscular hypertrophy.
16355486|NCT00218920|Behavioral|continuous moderate-intensity aerobic training|The moderate-intensity group walked continuously for 47 min at 60-70% of maximum heart rate (HRmax) to ensure that the training protocols were isocaloric.
16355487|NCT00218920|Behavioral|high-intensity interval aerobic training|High-intensity training consisted of a 10 min warm-up period at 50-60% of HRmax [maximal HR (heart rate)], followed by 4×4-min intervals at 85-95% of HRmax with 3 min active breaks in between the intervals, consisting of walking or jogging at 50-60% of HRmax. The exercise session was terminated by a 5 min cool-down period.
16355488|NCT00218907|Procedure|Educational video|
16355489|NCT00218894|Procedure|Cataract surgery|surgery one one or two eyes by use of two different types of lenses and correcting for refraction
16355490|NCT00218881|Procedure|HIV educational video|
16355491|NCT00218868|Procedure|Skin scrape|scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis
16355492|NCT00218855|Drug|thalidomide|tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.
16355493|NCT00218855|Drug|placebo|100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.
16355494|NCT00218842|Behavioral|Individualized exercise|individualized exercise, physical activity and training in daily life situations given by trained physical therapists and occupational therapists
16355495|NCT00218816|Behavioral|Nebulizer Education Intervention|Asthma Education
16355496|NCT00218816|Behavioral|Standard Asthma Education Groups|Asthma Education
16355497|NCT00218803|Behavioral|Nurse asthma education intervention|Asthma Education
16355498|NCT00218803|Behavioral|Control Group|Asthma Education
16355499|NCT00218790|Procedure|Cool Dialysate|Decreased temperature of the dialysis bath
16355500|NCT00218777|Behavioral|Comprehensive Behavioral Intervention for Tics|
16355501|NCT00218751|Behavioral|Home Visiting|
16355502|NCT00218725|Behavioral|Cognitive Therapy|The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
16355503|NCT00218725|Other|Enriched Care|The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health and substance abuse treatment in the community.
16355504|NCT00218712|Behavioral|Cognitive behavioral intervention|Cognitive behavioral intervention will include personalized cognitive counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
16355505|NCT00218712|Behavioral|Standard counseling|Participants will receive standard counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
16355506|NCT00218699|Behavioral|Cognitive-Behavioral Intervention|
16355507|NCT00218686|Behavioral|psychoeducational|psychoeducational
16355508|NCT00218686|Behavioral|control|VTC
16355509|NCT00218673|Behavioral|Peer mentor intervention|groups sessions, 8
16355510|NCT00218660|Drug|Naltrexone|150mg/day Naltrexone
16355511|NCT00218660|Behavioral|BRENDA|Psychosocial Treatment
16355512|NCT00218660|Behavioral|CBT|Cognitive Behavioral Therapy
16355513|NCT00218660|Drug|Placebo|
16362148|NCT00158405|Drug|Ritonavir (NRV)|
16355514|NCT00218634|Behavioral|CBT-AD|Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.
16355515|NCT00218634|Behavioral|ETAU|Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.
16355516|NCT00218621|Procedure|Buprenorphine / methadone|Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women
16355517|NCT00218608|Drug|Disulfiram|Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
16355518|NCT00218595|Behavioral|DBT|Dialectical behavior therapy plus opiate replacement medication.
16355519|NCT00218595|Behavioral|I/GDC|Individual and group drug counseling plus opiate replacement medication.
16355520|NCT00218582|Behavioral|Double Trouble in Recovery|Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment
16355521|NCT00218582|Behavioral|Standard psychiatric day treatment|Individual counseling, groups, medication
16355522|NCT00218569|Drug|Naltrexone|Naltrexone
16355523|NCT00218569|Drug|Placebo|Placebo
16355524|NCT00218556|Behavioral|Cognitive behavioral treatment for depression|Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
16355525|NCT00218543|Drug|Atomoxetine|At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.
16355526|NCT00218530|Drug|Lofexidine|
16355527|NCT00218517|Drug|Selegiline hydrochloride|Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
16355528|NCT00218517|Drug|Placebo|Matching placebo capsules using blue 00 capsules
16355529|NCT00218504|Drug|Tetrahydrocannabinol|Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo.
16355530|NCT00218491|Drug|N-Acetylcysteine|1200mg N-Acetylcysteine
16355531|NCT00218491|Drug|N-Acetylcysteine|2400mg N-Acetylcysteine
16355532|NCT00218491|Drug|Matching Placebo|Matching Placebo
16355533|NCT00218478|Behavioral|Cue Desensitization|During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues.
16355534|NCT00218465|Drug|GW468816|Pharmacotherapies for Relapse Prevention
16355535|NCT00218465|Drug|Placebo Comparator: Placebo|
16355536|NCT00218452|Behavioral|Lifestyle counseling|assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking
16355537|NCT00218439|Drug|Paroxetine|10 mg for 1 week followed by 20 mg for 3 weeks
16355538|NCT00218439|Drug|Placebo|
16355539|NCT00218426|Drug|naltrexone implant|naltrexone implant is 1000 mg naltrexone
16355540|NCT00218426|Drug|oral naltrexone|oral naltrexone 50 mg/day
16355541|NCT00218426|Drug|oral placebo naltrexone|oral placebo naltrexone resembles active medication
16355542|NCT00218426|Drug|placebo implant|placebo implant resembles active medication
16355543|NCT00218413|Biological|NicVAX|100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
16355544|NCT00218413|Biological|NicVAX|200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
16355545|NCT00218413|Biological|NicVAX|200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
16355546|NCT00218413|Biological|NicVAX|300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
16355547|NCT00218413|Biological|NicVAX|400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
16355548|NCT00218387|Drug|Modafinil|200mg Modafinil
16355549|NCT00218387|Drug|Modafinil|400mg Modafinil
16355550|NCT00218387|Drug|Matching Placebo|Matching Placebo
16355551|NCT00218374|Drug|Gabapentin|Gabapentin initiated up to a daily dose of 2400mg PO x 5 weeks
16355552|NCT00218361|Drug|Hydromorphone|
16355553|NCT00218348|Drug|Dextro-Amphetamine Sulfate|
16355554|NCT00218335|Behavioral|Intervention Condition|In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
16355555|NCT00218335|Behavioral|Control Condition|The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
16355556|NCT00218322|Drug|Atomoxetine hydrochloride|Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
16355557|NCT00218322|Drug|Placebo|Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
16355558|NCT00218309|Drug|Hydromorphone|
16355559|NCT00218296|Drug|Usual Care Group|Nicotine replacement therapy
16355560|NCT00218296|Other|Reduction Group|Subject selects preferred method for reduction.
16355561|NCT00218283|Drug|Nicotine Lozenge|Oral Nicotine replacement product
16355562|NCT00218283|Behavioral|Behavioral Counseling|Use of behavioral counseling to reduce tobacco use.
16355563|NCT00218270|Drug|Tobacco free snuff|Tobacco free snuff
16355564|NCT00218257|Drug|Progesterone|200mg progesterone twice daily
16355565|NCT00218257|Other|Placebo|placebo
16355566|NCT00218244|Other|Lower Nicotine Smokeless Tobacco Product|Skoal for 50% reduction;Skoal bandits for 75% reduction.
16355567|NCT00218244|Other|Behavioral Counseling|Behavioral counseling alone for reduction in tobacco use.
16355568|NCT00218231|Drug|300 mg/day bupropion-sr|300 mg/day for 1 week
16355569|NCT00218231|Drug|0 mg/day bupropion-sr|0 mg/day bupropion-sr
16355570|NCT00218218|Drug|Transdermal Nicotine Patch|42 mg transdermal nicotine
16355571|NCT00218218|Drug|21 mg transdermal nicotine|
16355572|NCT00218218|Drug|placebo patch|
16355573|NCT00218205|Drug|Epirubicin|
16355574|NCT00218205|Drug|Estramustine Phosphate|
16355575|NCT00218205|Drug|Celecoxib|
16355576|NCT00218192|Behavioral|Behavior Therapy|
16355577|NCT00218179|Other|Non-intervention|Measured total NNAL and PheT as biomarkers of exposure
16355578|NCT00218166|Drug|GABA Agonists|GABA drugs administered acutely by mouth
16355579|NCT00218153|Drug|Naltrexone|
16355580|NCT00218140|Drug|nicotine transdermal system|
16355581|NCT00218127|Drug|Levoacetyl Methadol|WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
16355582|NCT00218127|Drug|Levoacetyl Methadol|MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
16355583|NCT00218127|Drug|Levoacetyl Methadol|LAAM Fixed Dose evaluation up to 48 mg 48 mg
16355584|NCT00218114|Drug|Divalproex Sodium|Participants are titrated over 2 weeks, as tolerated to 10 mgs / pound, and blood levels are checked to determine that the blood level is between 50-110 micrograms / ml.
16355585|NCT00218114|Drug|Placebo|Participants will be on matching placebo.
16355586|NCT00218101|Drug|Buprenorphine|
16355587|NCT00218075|Drug|Levodopa|
16355588|NCT00218075|Drug|Carbidopa|
16355589|NCT00218075|Behavioral|Clinical Management|
16355590|NCT00218075|Behavioral|Relapse Prevention Therapy|
16355591|NCT00218075|Behavioral|Contingency Management|
16355592|NCT00218062|Drug|D-Amphetamine 30mg|
16355593|NCT00218062|Drug|D-Amphetamine 60mg|
16355594|NCT00218062|Drug|Modafinil 200mg|
16355595|NCT00218062|Drug|Modafinil 400mg|
16355596|NCT00218062|Behavioral|Therapy|Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
16355597|NCT00218062|Drug|Placebo|
16355598|NCT00218049|Drug|GBR 12909|50mg GBR 12909 over 12 days
16355599|NCT00218049|Drug|GBR 12909|GBR 12909 75 mg over 12 day period
16355600|NCT00218049|Drug|GBR 12909|GBR 12909 100 mg over 12 day period
16355601|NCT00218036|Drug|Modafinil 200mg|10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
16355602|NCT00218036|Drug|Modafinil 400mg|10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
16355603|NCT00218036|Drug|Citalopram 20mg|10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
16355604|NCT00218036|Drug|Citalopram 40mg|10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
16355605|NCT00218036|Drug|Placebo|Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
16355606|NCT00218023|Drug|Modafinil|The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase I.
16355607|NCT00218023|Drug|Levodopa/Carbidopa|Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase I.
16355608|NCT00218023|Drug|Naltrexone HCl|Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase I.
16355609|NCT00218023|Drug|Placebo|Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
16355610|NCT00218023|Behavioral|Motivational Interviewing (MI)|The primary goal of motivational interviewing (MI) was to assist patients in achieving initial abstinence by increasing motivation and commitment to change. The MI intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. The client-centered, MI-style sessions focused on building motivation for change, exploring ambivalence, obtaining a commitment to change, making a plan for abstinence (Session 1), providing personalized feedback, reassessing commitment for change, and reevaluating the change plan (Session 2). Masters-level therapists were trained and supervised by the therapy supervisor (ALS), an expert in motivation-based therapies.
16355611|NCT00218023|Behavioral|Contingency management (CM)|Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during phase I) and medication compliance (during phase II).
16355612|NCT00218023|Behavioral|Cognitive-Behavioral Therapy (CBT)|Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. This therapy component focused on coping-skills training for resisting cocaine use in high-risk situations, based on relapse-prevention theory and manual-guided techniques. Therapy sessions were conducted by master's-level licensed professional counselors supervised by a licensed clinical psychologist, who monitored manual adherence and competency.
16355613|NCT00217984|Other|Usual Care|Referral to smoking cessation clinic
16355614|NCT00217984|Behavioral|Extended cognitive behavior therapy|16 sessions of cognitive behavior therapy over 6 months
16355615|NCT00217971|Drug|Dronabinol|Dronabinol
16355616|NCT00217971|Drug|Placebo|placebo
16355617|NCT00217958|Behavioral|SHS reduction intervention based on social cognitive learning theory|
16355618|NCT00217945|Behavioral|Shared-Decision Making|
16355619|NCT00217932|Drug|Divalproex Sodium (Depakote)|
16355686|NCT00217490|Behavioral|dietary counseling via nutritionist|A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
16355687|NCT00217490|Behavioral|combined computer and nutritionist|An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
16355688|NCT00217490|Other|physical activity counseling via computer|An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
16355689|NCT00217477|Drug|gemcitabine hydrochloride|Given IV
16355690|NCT00217477|Drug|paricalcitol|Given IV
16355620|NCT00217919|Behavioral|Health-Counselor Mediated Telephone Counseling Intervention|"A trained health counselor will conduct the TC sessions, which will occur every 6 weeks (total 8 calls). We expect the initial call to last 30 minutes, with subsequent calls lasting 20 minutes. Our intervention for our primary outcome of LDL-C lowering is expected to take most of this time. We will spend approximately 5 minutes addressing physical activity at the end of each session, using methods similar to those in our pilot TC study.
~We will use patient-centered counseling to promote adherence to lipid-lowering medication and LDL-C lowering diet. The intervention will also activate patients to discuss initiation or dose increase of lipid-lowering drugs with their physicians. While the focus of our intervention will be on LDL-C lowering, the TC intervention will also devote approximately 5 minutes of the typical 20 minute call to increasing physical activity."
16355621|NCT00217906|Behavioral|A+ Asthma early intervention program|
16355622|NCT00217893|Behavioral|Counseling|One-on-one behavioral counseling with pre-teen child; 8 to 10 weekly or bi-weekly sessions; focus on identifying sources of exposure to ETS and means to avoid exposure; goal-setting, role-playing, monitoring progress, feedback includes reported info and urine cotinine level.
16355623|NCT00217893|Behavioral|Urine Cotinine Feedback|Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
16355624|NCT00217893|Behavioral|Contingent Incentives|Child earns small prizes for on-task behavior in sessions, plus earns tokens redeemable for other prizes based on reduction in ETS exposure (reported and cotinine level).
16355625|NCT00217893|Behavioral|Usual education program|Participants will receive the usual education about ETS.
16355626|NCT00217880|Procedure|Bronchoscopy|A bronchoscopy test will occur to view the participant's airways.
16355627|NCT00217867|Behavioral|Animated character intervention with telephone follow-up|Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.
16355628|NCT00217854|Procedure|Bronchoscopic|Bronchoscopic procedure
16355629|NCT00217841|Drug|Aurograb|
16355630|NCT00217828|Drug|citalopram|
16355631|NCT00217815|Drug|Mycograb, Docetaxel|
16355632|NCT00217802|Behavioral|six-session telephone counseling program|
16355633|NCT00217789|Procedure|Bronchoalveolar Lavage and Venipuncture|
16355634|NCT00217776|Behavioral|Open Airways Educational Intervention|
16355635|NCT00217776|Behavioral|Peer Asthma Action Educational Intervention|
16355636|NCT00217763|Drug|3APS|
16355642|NCT00217724|Dietary Supplement|glutamine|Given orally
16355643|NCT00217724|Other|placebo|Given orally
16355644|NCT00217711|Drug|Capecitabine|capecitabine
16355645|NCT00217711|Drug|irinotecan hydrochloride|irinotecan hydrochloride
16355646|NCT00217711|Drug|oxaliplatin|oxaliplatin
16355647|NCT00217698|Drug|cisplatin|
16355648|NCT00217698|Drug|gefitinib|
16355649|NCT00217698|Drug|gemcitabine hydrochloride|
16355650|NCT00217672|Biological|bevacizumab|Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
16355651|NCT00217672|Drug|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
16355652|NCT00217659|Drug|anastrozole|
16355653|NCT00217659|Drug|goserelin acetate|
16355654|NCT00217646|Drug|Sorafenib Tosylate|Given orally
16355655|NCT00217633|Procedure|Conventional Surgery|
16355656|NCT00217620|Drug|sorafenib|800 mg per day, daily until progression
16355657|NCT00217607|Drug|paclitaxel|
16355658|NCT00217594|Drug|Alemtuzumab (Campath)|
16355659|NCT00217581|Biological|Bevacizumab|Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
16355660|NCT00217581|Drug|Docetaxel|Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
16355661|NCT00217581|Drug|Oxaliplatin|Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
16355662|NCT00217568|Biological|pegfilgrastim|
16355663|NCT00217568|Drug|carboplatin|
16355664|NCT00217568|Drug|docetaxel|
16355665|NCT00217555|Drug|gemcitabine hydrochloride|
16355666|NCT00217555|Drug|topotecan hydrochloride|
16355667|NCT00217542|Biological|recombinant interferon alfa-2b|Given SC
16355668|NCT00217542|Drug|amifostine/azacitidine|Given SC
16355669|NCT00217529|Biological|pegfilgrastim|
16355670|NCT00217529|Drug|carboplatin|
16355671|NCT00217529|Drug|docetaxel|
16355672|NCT00217529|Drug|erlotinib hydrochloride|
16355673|NCT00217516|Drug|selenium|Given orally
16355674|NCT00217516|Other|placebo|Given orally
16355675|NCT00217503|Biological|bevacizumab|
16355676|NCT00217503|Biological|filgrastim|
16355677|NCT00217503|Biological|pegfilgrastim|
16355678|NCT00217503|Drug|bortezomib|
16355679|NCT00217503|Drug|cyclophosphamide|
16355680|NCT00217503|Drug|doxorubicin hydrochloride|
16355681|NCT00217503|Drug|etoposide|
16355682|NCT00217503|Drug|ganciclovir|
16355683|NCT00217503|Drug|valganciclovir|
16355684|NCT00217503|Drug|zidovudine|
16355685|NCT00217490|Behavioral|dietary counseling via computer|An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
16355691|NCT00217464|Drug|fulvestrant|intramuscularly
16355692|NCT00217451|Drug|Fosmidomycin-clindamycin|
16355694|NCT00217438|Drug|amifostine trihydrate|Given IV
16355695|NCT00217438|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16355696|NCT00217438|Genetic|fluorescence in situ hybridization|Correlative study
16355697|NCT00217438|Procedure|bone marrow ablation with stem cell support|Undergo transplant
16355698|NCT00217425|Biological|bevacizumab|"A - CHOP: 15 mg/kg IV infusion once every 21 days for 6-8 cycles. Bevacizumab is to be administered prior to CHOP therapy. Continuous bevacizumab: 15 mg/kg IV infusion once every 21 days.
~Initial dose should be infused over 90 minutes. If no adverse reactions occur, the second dose should be administered over 60 minutes. Again, if no adverse reactions occur, the third and subsequent doses should be administered over 30 minutes. If infusion-related adverse reactions occur, subsequent infusions should be administered over the shortest period that is well-tolerated. Infusions should be run in via a volumetric infusion device. Do NOT administer as an IV push or bolus."
16355699|NCT00217425|Drug|cyclophosphamide|IV infusion per institutional guidelines.
16355700|NCT00217425|Drug|doxorubicin|Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.
16355701|NCT00217425|Drug|prednisone|Prednisone is taken orally.
16355702|NCT00217425|Drug|vincristine|IV push using extravasation precautions.
16355703|NCT00217412|Drug|vorinostat|Given orally
16355704|NCT00217412|Drug|isotretinoin|Given orally
16355705|NCT00217399|Drug|sorafenib tosylate|Given orally
16355706|NCT00217399|Drug|anastrozole|Given orally
16355707|NCT00217386|Biological|anti-thymocyte globulin|
16355708|NCT00217386|Biological|etanercept|
16355709|NCT00217373|Biological|Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine|Given SC
16355710|NCT00217373|Biological|Recombinant Interferon Alfa-2b|Given SC
16355711|NCT00217373|Biological|Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine|Given SC
16355712|NCT00217373|Biological|Sargramostim|Given SC
16355713|NCT00217360|Behavioral|a customised multifactorial falls prevention program|
16355714|NCT00217347|Device|Esophageal Capsule Endoscopy|
16355715|NCT00217334|Behavioral|Volunteer-led pharmacy sessions with feedback to physicians|
16355716|NCT00217308|Drug|Lactobacilli GR-1 and RC-14|Probiotic Lactobacilli will be compared to placebo
16355717|NCT00217295|Drug|Avonex and Topamax|
16355718|NCT00217282|Drug|oxaliplatin, gemcitabine, bevacizumab|"Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity.
~Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance:
~Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression"
16355719|NCT00217269|Device|Coronary Artery Stenting|Endeavor Drug eluting stent
16355720|NCT00217269|Device|Coronary Artery Stenting|Taxus Drug Eluting Stent
16355721|NCT00217256|Device|Percutaneous Coronary Stenting|Endeavor Drug Eluting Stent
16355722|NCT00217256|Device|Percutaneous Coronary Stenting|Cypher Drug Eluting Stent
16355723|NCT00217243|Other|Evoked fields before and after a local block (Xylocaine)|MEG registration after electrical median and ulnar nerve stimulation in subjects and patients. In the patient group another MEG was performed after an anaesthetic block (1-2 ml Lidocaine 1%) at the site of the nerve injury producing a painfree state
16355724|NCT00217230|Biological|CAIV-T|
16355725|NCT00217217|Device|Echo-Planar Magnetic Resonance Imaging (EP-MRSI)|variable-setting low-frequency MRI
16355726|NCT00217204|Drug|Pancrelipase microtablets|
16355727|NCT00217191|Drug|Ibuprofen|
16355728|NCT00217178|Drug|Vitamins: Folic acid, B6, B12|
16355729|NCT00217165|Drug|taurine|taurine 2mg BID po
16355730|NCT00217152|Drug|CellCept|
16355731|NCT00217139|Drug|Celgosivir|
16355732|NCT00217113|Behavioral|Geriatric home visit and Action Plan|
16355733|NCT00217100|Dietary Supplement|Multivitamin|1 tablet a day
16355734|NCT00217100|Dietary Supplement|Placebo|1 tablet a day
16355735|NCT00217087|Procedure|Endoscopic Mucosal Resection|Endoscopic mucosal resection at time of endoscopy if indicated.
16355736|NCT00217087|Procedure|Photodynamic Therapy|Porfimer sodium 2mg/kg
16355737|NCT00217074|Other|acupuncture|
16355738|NCT00217061|Device|Decision Aid Statin Choice|
16355739|NCT00217048|Drug|Yohimbine, oral|
16355740|NCT00217035|Dietary Supplement|TPN or TPN enriched with glutamine|Each patient undergoes two nutritional support periods either with or without Glutamine supplementation.
16355741|NCT00217022|Other|Placebo|Placebo, 3 tablets daily
16355742|NCT00217022|Drug|Budesonide|9 mg daily (three tablets)
16355743|NCT00217009|Procedure|Narrowband Ultraviolet B (TL-01UVB) Therapy|
16355744|NCT00217009|Procedure|Topical Psoralen plus ultraviolet A (PUVA)|
16355745|NCT00216970|Dietary Supplement|Alteration in nutritional support|The subject is randomized into one of two groups - One receives TPN that does not have arginine, proline or glutamate. The other will receive TPN with extra glutamine. The subject takes part in 3 tracer studies while in the hospital. For each tracer study, the subject will receive a different randomly assigned diet. Blood and air are sampled and the patient receives a stable isotope after which the tests are repeated.
16355746|NCT00216957|Procedure|Coronary bypass surgery without cardiopulmonary bypass|
16355747|NCT00216944|Procedure|Tracheal intubation for respiratory care in preterm infants|Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
16355748|NCT00216944|Procedure|Tracheal intubation for respiratory care in preterm infants|Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg
16355749|NCT00216931|Drug|iloprost|
16355750|NCT00216918|Drug|Atomoxetine Hydrochloride|
16355751|NCT00216892|Drug|Calcipotriol, (calcipotriol + betamethasone)|
16355752|NCT00216879|Drug|Calcipotriol plus betamethasone dipropionate gel (LEO 80185)|
16355753|NCT00216866|Drug|Dalteparin|
16355754|NCT00216866|Drug|Warfarin|
16355755|NCT00216840|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
16362149|NCT00158405|Drug|Indinavir (IDV)|
16355756|NCT00216827|Drug|Calcipotriol plus betamethasone dipropionate (LEO80185 gel)|
16355757|NCT00216788|Drug|Esomeprazole (Nexium) 40 mg/day|
16355758|NCT00216775|Drug|interferon-alfa-2b and ribavirin|
16355759|NCT00216762|Drug|Rituximab|Rituxan ® 1000 mg IV x 2 infusions, 2 weeks apart
16355760|NCT00216736|Drug|Dexamethasone|Single dose oral dexamethasone 8mg at time of ED discharge
16355761|NCT00216736|Drug|placebo|Single dose oral placebo at ED discharge
16355762|NCT00216723|Drug|Aripiprazole|"The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals.
~(Administer 10 to 30 mg/day according to the patient's condition)"
16355763|NCT00216710|Behavioral|Home Visiting|
16355764|NCT00216697|Drug|bortezomib|
16355765|NCT00216684|Drug|fentanyl|
16355766|NCT00216671|Drug|early initiation of treatment with Risperdal Consta|25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
16355767|NCT00216671|Drug|routine initiation of treatment with Risperdal Consta|25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
16355768|NCT00216658|Drug|fentanyl|
16355769|NCT00216645|Drug|doxorubicin hydrochloride|
16355770|NCT00216632|Drug|risperidone|
16355771|NCT00216619|Drug|Topiramate|topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.
16355772|NCT00216619|Drug|Topiramate - Placebo|the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)
16355773|NCT00216606|Drug|topiramate|
16355774|NCT00216593|Drug|galantamine hydrobromide|
16355775|NCT00216580|Drug|Risperidone, long-acting injectable|
16355776|NCT00216567|Drug|topamax|
16355777|NCT00216554|Drug|risperidone|
16355778|NCT00216541|Drug|epoetin alfa|
16355779|NCT00216528|Drug|risperidone|
16355780|NCT00216515|Drug|galantamine hydrobromide|
16355781|NCT00216502|Drug|galantamine hydrobromide|
16355782|NCT00216489|Drug|rabeprazole sodium|
16355783|NCT00216476|Drug|Aripiprazole|10-30 mg oral once daily for 104 weeks
16355784|NCT00216476|Drug|Risperidone Long Acting Injectable (LAI)|25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.
16355785|NCT00216476|Drug|Quetiapine|Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.
16355786|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks
16355787|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks
16355788|NCT00216463|Drug|ISIS 301012 or Placebo|300 mg subcutaneous injection - every week for 13 weeks
16355789|NCT00216463|Drug|ISIS 301012 or Placebo|400 mg subcutaneous injection - every week for 13 weeks
16355790|NCT00216463|Drug|ISIS 301012 or Placebo|200 mg subcutaneous injection - every week for 13 weeks
16355791|NCT00216450|Drug|rabeprazole sodium|
16355792|NCT00216437|Drug|Capecitabine (Xeloda)|
16355793|NCT00216424|Drug|Capecitabine (Xeloda)|
16355794|NCT00216411|Biological|Botulinum toxin type A|
16355795|NCT00216411|Drug|Placebo|
16355796|NCT00216398|Drug|Lanreotide (Autogel formulation)|
16355797|NCT00216385|Drug|Gatifloxacin combined regimen|
16355798|NCT00216372|Drug|Lanreotide (microparticle formulation)|A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
16355799|NCT00216372|Other|Placebo|A single intra-muscular injection on day 0.
16355800|NCT00216359|Drug|Fuzeon (Enfuvirtide)|
16355801|NCT00216359|Procedure|Laboratory diagnostic (CD4-cells)|
16355802|NCT00216359|Procedure|Laboratory diagnostics (HIV-1 viral load)|
16355803|NCT00216359|Drug|antiretroviral co-medication beside Fuzeon|
16355804|NCT00216346|Drug|Paromomycin sulfate|
16355805|NCT00216346|Drug|Amphotericin B|
16355806|NCT00216333|Drug|combined fixed dose combination|
16355807|NCT00216320|Device|WalkAide|Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
16355808|NCT00216320|Device|AFO|Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
16355809|NCT00216320|Device|AFO|Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
16355810|NCT00216294|Drug|RG1068 (Synthetic Human Secretin)|
16355811|NCT00216281|Drug|Clozapine augmented with atomoxetine up to 40 mg or placebo|
16355812|NCT00216268|Drug|Ribavirin|
16355813|NCT00216255|Drug|Pagoclone|
16355814|NCT00216255|Drug|Placebo|
16355815|NCT00216242|Biological|Influenza virus vaccine (Fluviral)|
16355816|NCT00216242|Biological|Saline placebo|
16355817|NCT00216229|Biological|Combined vaccine against hepatitis A and B (Twinrix)|
16355818|NCT00216216|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV q 3 weeks
16355819|NCT00216203|Drug|Pemetrexed|Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
16355820|NCT00216203|Drug|Cetuximab|"Cetuximab 400 mg/m2, week 1, day 1
~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
16362377|NCT00156143|Procedure|Radiography|
16355821|NCT00216190|Drug|Dexmedetomidine HCL Injection|
16355822|NCT00216190|Drug|Midazolam Injection|
16355823|NCT00216177|Drug|Infliximab|Remicade
16355824|NCT00216177|Drug|Adalimumab|Humira
16355825|NCT00216164|Drug|Rituximab|Rituximab 375 mg/m2, day 1 of 21 day cycle
16355826|NCT00216164|Drug|Gemcitabine|Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle
16355827|NCT00216151|Drug|Zoledronic Acid|Zoledronic Acid 4mg, every three months
16355828|NCT00216138|Drug|Docetaxel|Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
16355829|NCT00216138|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
16355830|NCT00216138|Drug|Premedication|Dexamethasone and antiemetic premedication
16355831|NCT00216125|Drug|Cisplatin|Cisplatin 50 mg/m2 day 1, 8, 29, 36
16355832|NCT00216125|Drug|Etoposide|Etoposide 50 mg/m2, days 1-5, 29-33
16355833|NCT00216125|Radiation|Radiation|Radiation 5940 cGy (180 cGy/day)
16355834|NCT00216125|Drug|Docetaxel|docetaxel 75mg/m2 q3wk x 3 cycles
16355835|NCT00216112|Drug|Imatinib Mesylate|Imatinib mesylate 600 mg po qd
16355836|NCT00216112|Drug|Docetaxel|Docetaxel 30 mg/m2 (4 of 6 weeks); 1 cycle = 6 weeks
16355837|NCT00216099|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
16355838|NCT00216099|Dietary Supplement|Folic Acid|All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed.
16355839|NCT00216099|Dietary Supplement|Vitamin B12|All patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.
16355840|NCT00216086|Drug|Capecitabine|"Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid"
16355841|NCT00216086|Drug|Irinotecan|Irinotecan 200 mg/m2 IV, day 1
16355842|NCT00216086|Procedure|EUS|biopsy per EUS
16355843|NCT00216086|Drug|Neoadjuvant Chemotherapy|"Irinotecan 200 mg/m2 IV, day 1
~Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles"
16355844|NCT00216086|Procedure|Preoperative Radiation|Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
16355845|NCT00216086|Procedure|Surgery|Surgery within 8 weeks following chemoradiotherapy
16355846|NCT00216086|Procedure|Adjuvant Chemotherapy|Adjuvant chemotherapy at investigator's discretion
16355847|NCT00216073|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
16355848|NCT00216073|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV, day 1
16355849|NCT00216073|Drug|Trastuzumab|Trastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only.
16355850|NCT00216060|Drug|Risedronate|Daily oral risedronate combined with androgen deprivation
16355851|NCT00216060|Drug|Placebo|Daily oral placebo combined with androgen deprivation
16355852|NCT00216047|Drug|PTK787|PTK787 daily
16355853|NCT00216047|Drug|Trastuzumab|Trastuzumab 4 mg/kg IV week 1, followed by 2 mg/kg weekly with disease evaluation every other cycle*
16355854|NCT00216034|Drug|Tegafur-gimeracil-oteracil potassium (TS-1)|From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7
16355855|NCT00216034|Drug|Krestin (PSK)|From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
16355856|NCT00216021|Drug|Capecitabine|Capecitabine 825 mg/m2 po bid, days 1-14
16355857|NCT00216021|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IV, day 1
16355858|NCT00216008|Drug|docetaxel|
16355859|NCT00216008|Drug|cisplatin|
16355860|NCT00216008|Procedure|radiation|
16355861|NCT00216008|Procedure|surgery|
16355862|NCT00215995|Drug|Cisplatin|As outlined in Detailed Description
16355863|NCT00215995|Drug|Irinotecan|As outlined in Detailed Description
16355864|NCT00215995|Drug|ZD 1839|As outlined in Detailed Description
16355865|NCT00215982|Drug|capecitabine|Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
16355866|NCT00215982|Drug|Oxaliplatin|Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
16355867|NCT00215982|Drug|Irinotecan|Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
16355868|NCT00215956|Drug|topotecan|Preoperative treatment: oral topotecan 5 days per week for up to 5 weeks
16355869|NCT00215956|Procedure|radiation|Preoperative radiation
16355870|NCT00215956|Procedure|surgery|surgery to remove tumor 4 to 8 weeks following completion of preoperative treatment
16355871|NCT00215943|Drug|zoledronic acid|Patients were randomized to receive zoledronic acid I.V. on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance.
16355872|NCT00215943|Drug|dexamethasone|As outlined in VAD Treatment arm and Thalidomide and Dexamethasone Treatment arm
16355873|NCT00215943|Drug|thalidomide|As outlined in Thalidomide and Dexamethasone Treatment arm
16355874|NCT00215943|Drug|vincristine|As outlined in VAD Treatment Arm
16355875|NCT00215943|Drug|adriamycin|As outlined in VAD Treatment arm
16355876|NCT00215930|Drug|Vinorelbine|Ribonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
16355916|NCT00215579|Drug|Depot Risperidone Microsphere (Consta)|
16355917|NCT00215566|Drug|DDP733|
16355918|NCT00215553|Drug|A.1 Lucinactant|3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
16355919|NCT00215553|Other|B.3 SoC|Standard ARDS management and ICU care
16355877|NCT00215930|Drug|Docetaxel|"RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days.
~RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days.
~RRM1 above 16.5 and ERCC1 above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days."
16355878|NCT00215930|Drug|Gemcitabine|"Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
~RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days."
16355879|NCT00215930|Drug|Carboplatin|"Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
~RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days."
16355880|NCT00215917|Drug|D-serine 2100 mg daily|
16355881|NCT00215904|Drug|D-serine (~2g/day)|Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).
16355882|NCT00215891|Drug|PEG-Interferon a-2b + Ribavirin|
16355883|NCT00215878|Drug|D-serine (~2g /day)|Two 6 weeks treatment arms under a cross over design. In one arm adjuvant treatment with experimental medication (D-serine ~2g /day), in the second arm adjuvant treatment with placebo (~2g /day)
16355884|NCT00215865|Drug|PEGIntron plus ribavirin|
16355885|NCT00215852|Drug|Alferon LDO|500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.
16355886|NCT00215839|Drug|Peginterferon a-2a plus Ribavirin|
16355887|NCT00215826|Drug|Alferon LDO|
16355888|NCT00215813|Drug|Poly I: Poly C12U (Rintatolimod)|200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
16355889|NCT00215800|Drug|Ampligen|
16355890|NCT00215787|Drug|lansoprazole|Lansoprazole 30 mg BID for 1 year
16355891|NCT00215774|Drug|Flecainide|Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
16355892|NCT00215748|Drug|Dexamethasone|
16355893|NCT00215735|Device|debridement, dressing, and APC|ebridement, dressing, and APC
16355894|NCT00215722|Drug|Cetuximab|
16355895|NCT00215709|Drug|docetaxel|
16355896|NCT00215696|Genetic|BioBypass®|
16355897|NCT00215683|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
16355898|NCT00215670|Drug|pegaptanib sodium (Macugen)|
16355899|NCT00215657|Drug|Degarelix|Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355900|NCT00215657|Drug|Degarelix|Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355901|NCT00215657|Drug|Degarelix|Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355902|NCT00215657|Drug|Degarelix|Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355903|NCT00215657|Drug|Degarelix|Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355904|NCT00215657|Drug|Degarelix|Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355905|NCT00215657|Drug|Degarelix|Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355906|NCT00215657|Drug|Degarelix|Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
16355907|NCT00215644|Drug|Matuzumab|Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
16355908|NCT00215644|Drug|Epirubicin|Participants will receive epirubicin 50 milligrams per square meter (mg/m^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
16355909|NCT00215644|Drug|Cisplatin|Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
16355910|NCT00215644|Drug|Capecitabine|Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.
16355911|NCT00215631|Drug|tadalafil|
16355912|NCT00215618|Device|Uterine Balloon Therapy|UBT with post procedure curettage
16355913|NCT00215618|Device|Uterine Balloon Therapy|UBT without post procedure curettage
16355914|NCT00215605|Drug|XL184|Flavored liquid suspension or gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing or intermittent schedule (daily dosing followed by dosing holiday in cycles)
16355915|NCT00215592|Drug|Zonegran|
16355920|NCT00215553|Drug|A.2 Lucinactant|3 30 mL aliquots at a concentration of 10 mg/mL each
16355921|NCT00215553|Drug|A.3 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL
16355922|NCT00215553|Drug|A.4 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
16355923|NCT00215553|Drug|B.1 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL
16355924|NCT00215553|Drug|B.2 Lucinactant|2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
16355925|NCT00215540|Drug|Lucinactant 175 mg/kg|Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).
16355926|NCT00215540|Drug|Lucinactant 90 mg/kg|Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
16355927|NCT00215540|Drug|Placebo|Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).
16355928|NCT00215527|Drug|laronidase|0.58 mg/ml solution for intravenous injection, dose 1.74 mg intrathecally once per month for four injections.
16355929|NCT00215514|Drug|Epirubicin|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
16355930|NCT00215514|Drug|Cisplatin|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
16355931|NCT00215514|Drug|5-Fluorouracil (5-FU)|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
16355932|NCT00215514|Procedure|Radiation|Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
16355933|NCT00215501|Drug|Capecitabine|Orally twice a day for 14 days (dosage will vary)
16355934|NCT00215501|Drug|5-Fluorouracil (5-FU)|Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
16355935|NCT00215501|Drug|Irinotecan|Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
16355936|NCT00215501|Drug|Cisplatin|Intravenously weekly for 2 weeks followed by a one week rest period
16355937|NCT00215462|Drug|Vinorelbine|
16355938|NCT00215449|Drug|Formoterol Fumarate|
16355939|NCT00215436|Drug|Formoterol Fumarate|
16355940|NCT00215423|Drug|Formoterol Fumarate|
16355941|NCT00215410|Drug|Formoterol Fumarate|
16355942|NCT00215397|Drug|Formoterol Fumarate|
16355943|NCT00215384|Drug|Formoterol Fumarate|
16355944|NCT00215371|Drug|Formoterol Fumarate|
16355945|NCT00215358|Drug|Formoterol Fumarate|
16355946|NCT00215345|Drug|Taxotere|
16355947|NCT00215345|Drug|Celecoxib|
16355948|NCT00215332|Device|CHARITE|Lumbar Total Disc Replacement
16355949|NCT00215319|Device|Lumbar I/F with cage and pedicle screws|Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
16355950|NCT00215306|Device|CHARITÉ Artificial Disc|
16355951|NCT00215306|Device|Anterior Interbody Fusion with BAK Cage|
16355952|NCT00215293|Device|Cervical I/F Cage|
16355953|NCT00215293|Device|Autograft or allograft with a plate, or autograft alone.|
16355954|NCT00215280|Drug|ivermectin and albendazole|
16355955|NCT00215267|Drug|praziquantel|
16355956|NCT00215254|Drug|quetiapine|
16355957|NCT00215241|Drug|sertraline and risperidone|
16355958|NCT00215228|Drug|duloxetine vs. escitalopram|
16355959|NCT00215215|Device|Vagus Nerve Stimulation Therapy|
16355960|NCT00215202|Drug|Iressa (ZD1839)|
16355961|NCT00215189|Behavioral|In SHAPE (Pilot Health Promotion Intervention)|
16355962|NCT00215176|Drug|modafinil|
16355963|NCT00215163|Drug|Cognitive-behavioral therapy and paroxetine-CR|
16355964|NCT00215150|Drug|Ziprasidone|Sertraline augmentation with ziprasidone
16355965|NCT00215150|Drug|Sertraline|Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
16355966|NCT00215137|Drug|escitalopram|Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.
16355967|NCT00215137|Drug|Placebo ( sugar pill)|Placebo Comparator in double.blind phase.
16355968|NCT00215124|Drug|Filgrastim|
16355969|NCT00215111|Behavioral|Low carbohydrate, reduced glycemic load, and a control diet|
16355970|NCT00215046|Drug|Vinblastine|drug - dosage and frequency is based on size of patient and response to treatment.
16355971|NCT00215046|Drug|Methotrexate|drug - dosage is based on size of patient and frequency and duration is based on response to treatment.
16355972|NCT00215007|Drug|Levofloxacin|
16355973|NCT00214994|Drug|Gabitril|
16355974|NCT00214981|Drug|Modafinil|
16355975|NCT00214968|Drug|Modafinil|maximum dosage 400 mg/day (4 tablets)
16355976|NCT00214955|Drug|ORAVESCENT Fentanyl Citrate|
16355977|NCT00214942|Drug|ORAVESCENT Fentanyl Citrate|
16355978|NCT00214929|Behavioral|treatment at home|
16355979|NCT00214916|Drug|intensive insulin therapy (Actrapid IV to normoglycemia)|intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
16355980|NCT00214916|Drug|conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)|conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
16355981|NCT00214890|Drug|Tenofovir|300 mg once daily
16355982|NCT00214890|Drug|Abacavir|600 mg once daily
16355983|NCT00214877|Drug|Methylene Blue|
16355984|NCT00214864|Drug|docetaxel, capecitabine|cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8
16355985|NCT00214851|Drug|Kineret (anakinra)|Kineret (anakinra 100 mg. s/c daily x 4 weeks
16355986|NCT00214838|Drug|Atiprimod|
16355987|NCT00214825|Drug|eplerenone|50 mg daily for 6 weeks with placebo
16355988|NCT00214825|Drug|Hydrochlorothiazide|HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks
16355989|NCT00214812|Drug|HEC placebo gel|
16355990|NCT00214786|Biological|Islet cell transplantation|Allogenic islet transplantation
16355991|NCT00214760|Device|PGET|resolbable liner
16355992|NCT00214760|Device|PMMA|cement liner
16355993|NCT00214747|Drug|Vehicle gel formulations|
16355994|NCT00214734|Drug|rAHF-PFM|
16355995|NCT00214721|Drug|Experimental Peritoneal Dialysis Solution|
16355996|NCT00214708|Procedure|Screening for Tuberculosis|
16355997|NCT00214695|Drug|Experimental Peritoneal Dialysis Solution|
16355998|NCT00214682|Drug|Folate (400mcg) and Vitamin B12 (100 mcg)|The vitamin intervention was a daily oral dose of one tablet consisting of folic acid 400 mcg + vitamin B12 100 mcg. The folic acid dose of 400 mcg / day was selected as it has been shown to be the dose associated with 90% of the maximal decrease in plasma homocysteine concentration for older individuals. Participants received 1 bottle x 200 tablets in six-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months).
16355999|NCT00214682|Behavioral|mediated physical activity promotion|Individuals in the Physical Activity Promotion group received a manual designed to promote older individuals' physical activity participation to the level recommended to gain both physical and mental health benefits. The framework of the physical activity manual was informed by social cognitive theory and the transtheoretical model, and comprised five sections that reflect stages of behaviour change, including; precontemplation, contemplation, preparation, action, and maintenance. The manual contained evidence-based strategies and skills to assist people in increasing their physical activity levels. Participants received a pedometer at the commencement of the intervention as pedometry step / minute values are useful as an indicator of moderate to vigorous physical activity with total number of steps for one week recorded during the brief telephone calls at 1-5 weeks, and 4-, 8-, 13-, 18-, and 22- months.
16356000|NCT00214682|Behavioral|Mental health literacy|Comprises 10 modules, with nine of these specifically written for older adults. Modules 1 to 5 comprised information on depression and the evidence-based treatment for older adults. The additional MHL modules were booklets addressing evidence-based strategies and treatments for depression. It was delivered in a way to foster support and ensure that participants worked through the material systematically. Modules 1 to 5 were delivered in consecutive weeks as previous research indicates that the maximum impact of MHL on depressive symptoms may occur within the first six weeks of the intervention. Telephone interviewers contacted participants once a week for 5 consecutive weeks to motivate and support participants. There were an additional 5 check-in telephone calls, and Modules 6 to 10 of the MHL material that were delivered via postal mail at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10).
16356001|NCT00214682|Drug|placebo|A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.
16356002|NCT00214682|Behavioral|Nutrition information|The attention control intervention for the physical activity intervention was printed nutrition literacy and included information concerning the recommended dietary guidelines for older Australians, as well as strategies and additional information to facilitate beneficial dietary behaviours. The same procedure was adhered to as the physical activity intervention to ensure adequate attention control. Participants in the nutrition promotion intervention received 5 brief telephone calls from an interviewer to facilitate adherence to the intervention, and to offer support and clarification of the materials. Participants received five further brief telephone calls as well as nutrition newsletters that were delivered via postal mail at 4-, 8-, 13-, 18-, and 22- months.
16356003|NCT00214682|Behavioral|pain and arthritis management information|Pain and Arthritis Information was used as the attention control intervention for the MHL intervention and comprised 10 modules. Modules 1 to 5 were contained in an Arthritis Australia consumer guide for arthritis management. Modules 6 to 10 were a series of information pamphlets on pain management, osteoporosis and falls prevention. The delivery of the Pain Information was identical to the MHL intervention with Modules 1 to 5 distributed via postal mail in five consecutive weeks (1-5 weeks), while the remaining intervention modules were delivered at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10). Participants also received 10 brief calls from a telephone interviewer that coincided with receiving the print intervention materials.
16356004|NCT00214669|Behavioral|PACE (Professional Asthma Care Education)|Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
16356005|NCT00214669|Behavioral|Lay Led Expert Patient Programme|Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.
16356006|NCT00214669|Behavioral|Asthma self management education by a specialist nurse|asthma education and self management, asthma action plans
16356007|NCT00214656|Drug|Recombinant Activated Factor VII|
16356008|NCT00214643|Drug|Fosmidomycin|30 mg/kg
16356009|NCT00214643|Drug|clindamycin|10 mg/kg
16356010|NCT00214630|Drug|rosuvastatin calcium|
16356011|NCT00214630|Drug|atorvastatin|
16356012|NCT00214617|Drug|Rosuvastatin at 5 mg/day and 40 mg/day|
16356013|NCT00214604|Drug|Rosuvastatin|10mg
16356014|NCT00214604|Drug|rosuvastatin|20mg
16356015|NCT00214604|Drug|pravastatin|40mg
16356016|NCT00214591|Drug|GALIDA|
16356017|NCT00214578|Drug|Seroquel (quetiapine)|
16356018|NCT00214565|Drug|Galida|
16356019|NCT00214552|Drug|rabeprazole|
16356020|NCT00214539|Procedure|Bronchial Thermoplasty with the Alair System|Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.
16356021|NCT00214539|Drug|Control|Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
16356022|NCT00214526|Procedure|Bronchial thermoplasty with the Alair System|Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
16356023|NCT00214526|Drug|Conventional therapy with ICS+LABA|Conventional therapy with ICS+LABA.
16356024|NCT00214513|Behavioral|Home-based exercise training|
16356025|NCT00214500|Drug|migalastat HCl|
16356026|NCT00214487|Device|Bifocal Contact Lenses|Use of bifocal contact lenses of varying add powers to control the progression of myopia
16356027|NCT00214487|Device|Placebo Control|Single vision soft contact lenses
16356028|NCT00214474|Behavioral|ATSM Intervention|Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
16356029|NCT00214474|Behavioral|GMV Intervention|GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
16356030|NCT00214461|Biological|Vaccine diluent buffer (Placebo)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
16356031|NCT00214461|Biological|C. difficile toxoid vaccine (2 µg)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
16356032|NCT00214461|Biological|C. difficile toxoid vaccine (10 µg)|0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
16356033|NCT00214461|Biological|C. difficile toxoid vaccine (50 µg)|0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
16356034|NCT00214435|Drug|once daily minimum 3-drug regimen of anti-retroviral medications|
16356035|NCT00214422|Radiation|Radiation|Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
16356036|NCT00214383|Behavioral|CHESS Internet telehealth|CHESS Internet telehealth
16356037|NCT00214370|Drug|Propofol-Fentanyl|
16356038|NCT00214370|Drug|Propofol alone|
16356039|NCT00214357|Behavioral|Mindfulness-based stress reduction|
16356040|NCT00214344|Behavioral|family preparation for withdrawing life support|
16356041|NCT00214331|Drug|ciprofloxacin|ciprofloxacin 500 mg twice a day for five doses.
16356042|NCT00214331|Drug|azithromycin|azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
16356043|NCT00214331|Drug|gentamicin|a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
16356044|NCT00214318|Drug|Terbutaline plus Metoprolol or carvedilol|
16356045|NCT00214305|Behavioral|Range of Motion Therapy Program|The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
16356046|NCT00214305|Behavioral|Postural Sensory Therapy Program|The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.
16356047|NCT00214292|Procedure|fluorescence spectroscopy and diffuse spectroscopy|
16356048|NCT00214279|Drug|Corticosteroid withdrawal|prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus
16356049|NCT00214266|Drug|Campath 1H®, Rituximab, mycophenolate mofetil|Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid
16356050|NCT00214253|Drug|Thiazolidinedione|Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
16356051|NCT00214240|Drug|CMV Immune globulin|CMV IvIg 150mg/kg x 6 doses
16356052|NCT00214214|Drug|Campath 1H® (Alemtuzumab)|
16356053|NCT00214201|Drug|Calcineurin inhibitor withdrawal|stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
16356054|NCT00214162|Behavioral|Comprehensive Health Enhancement Support System|Full CHESS
16356055|NCT00214162|Behavioral|computer with internet|computer with internet use x 1 year
16356056|NCT00214149|Radiation|brachytherapy|breast brachytherapy to 34 Gy
16356057|NCT00214136|Radiation|radiotherapy|prostate radiation to 70Gy; nodal radiation to 56Gy
16356058|NCT00214123|Radiation|radiation therapy (radiotherapy)|Bin assignment based on tumor volume
16356059|NCT00214110|Drug|Tamoxifen|
16356060|NCT00214097|Radiation|Radiotherapy|Daily radiation to prescribed dose
16356061|NCT00214084|Drug|Allopurinol|
16356062|NCT00214071|Biological|Influenza vaccine|
16356063|NCT00214058|Drug|Carboplatin|
16356064|NCT00214058|Drug|Docetaxel|
16356065|NCT00214045|Device|Flexible Cystoscopy|
16356066|NCT00214045|Device|Rigid Cystoscopy|
16356067|NCT00214032|Drug|Pycnogenol|pycnogenol 300 mg daily
16356068|NCT00214032|Drug|Placebo|placebo 3 capsules daily
16356069|NCT00214019|Drug|salmeterol|salmeterol diskus 50 mcg twice per day
16356070|NCT00214019|Drug|Fluticasone|placebo diskus, fluticasone MDI 88 mcg twice per day
16356071|NCT00214019|Drug|Placebo|placebo diskus
16356072|NCT00213993|Drug|antiperspirant|antiperspirant topically once daily to one foot
16356073|NCT00213980|Drug|Zoledronate|4 mg IV over 15 minutes administered once every 12 weeks times 4
16356074|NCT00213967|Device|22 gauge 1 1/2 inch needles on a 3 ml syringe|cold needles or needles kept at room temperature
16356075|NCT00213954|Procedure|ultrasound-guidance with echography|Locoregional anesthesia with or without ultrasound guidance practice
16356076|NCT00213941|Device|Echocardiography|
16356077|NCT00213928|Drug|Horse Chestnut Seed Extract|Control (no intervention) vs Horse Chestnut Seed Extract
16356167|NCT00212719|Drug|ONO-5920|
16356078|NCT00213915|Drug|12 g of L-arginine glutamate during 6 weeks twice a day|
16356079|NCT00213889|Other|None: molecular genetics diagnosis procedure only|None: molecular genetics diagnosis procedure only
16356080|NCT00213863|Device|Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting|The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.
16356081|NCT00213850|Procedure|EFR|
16356082|NCT00213837|Device|Mandibular prosthesis made of a new highly biointegratable material|Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.
16356083|NCT00213811|Behavioral|clinical, biological, and radiological|
16356084|NCT00213798|Procedure|Biopsy samples|
16356085|NCT00213759|Drug|filgrastim|The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.
16356086|NCT00213759|Drug|dextrose 5%|The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.
16356087|NCT00213694|Drug|docetaxel and celecoxib|
16356088|NCT00213681|Device|Boussignac CPAP - bilevel ventilation support|
16356089|NCT00213668|Dietary Supplement|glutamine (dipeptiven)|
16356090|NCT00213655|Biological|bladder tumor recurrence|bladder tumor recurrence assessed by clinical and biological exams
16356091|NCT00213629|Other|transcriptome analysis|transcriptome analysis from muscle biopsy
16356092|NCT00213629|Other|T cell repertoire analysis|blood T cell repertoire analysis
16356093|NCT00213616|Procedure|surgical reinnervation|laryngeal reinnervation with a phrenic nerve root
16356094|NCT00213590|Drug|cyclosporine A|The usual-exposure level was based on the mean area-under-the-concentration-time curve (AUC0-12h). In the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L and in the low-exposure group the target was 50% or 2.2 (2.0 to 2.6, range) mg•h/L. Ranges were asymmetrical for safety reasons, i.e., to prevent the occurrence of rejection in the low-exposure arm and nephrotoxicity in the usual-exposure arm.The AUC 0-12h was estimated using a Bayesian estimator and a three-point limited sampling strategy (0, 1, and 3 hours). A computer program was used to calculate the dose adjustment required to reach the therapeutic target. Doses were adjusted in increments of 25% to reach the target within 2 months. Cyclosporine AUC0-12h was determined every 2 months.
16356095|NCT00213577|Drug|type A botulinum toxin|
16356096|NCT00213564|Drug|response to infliximab associated with methotrexate|
16356097|NCT00213551|Drug|Glutamine|
16356098|NCT00213551|Drug|Glucose|
16356099|NCT00213551|Drug|glutamine-antioxidants containing solution|
16356100|NCT00213538|Drug|Response to anakinra associated with methotrexate|
16356101|NCT00213525|Other|Questionnary for environmental factors research|Questionnary for environmental factors research
16356102|NCT00213512|Drug|Mabthera|
16356103|NCT00213499|Procedure|non invasive ventilation|
16356104|NCT00213486|Drug|irinotecan|
16356105|NCT00213434|Device|Herbst oral appliance|
16356106|NCT00213421|Drug|Dermoval|group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)
16356107|NCT00213408|Procedure|Radiofrequency catheter ablation of typical atrial flutter|
16356108|NCT00213395|Device|Interface for noninvasive ventilation|
16356109|NCT00213330|Procedure|rectal distension|
16356110|NCT00213317|Procedure|lombo-sacral magnetic stimulation|repetitive lombo-sacral nerve magnetic stimulation active and placebo performed during colonic recordings after bisacodyl instillation
16356111|NCT00213304|Biological|varicella vaccine (VARIVAX)|
16356112|NCT00213291|Drug|darbepoetin alfa|Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.
16356113|NCT00213278|Drug|vinblastine sulphate injection|Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
16356114|NCT00213265|Biological|7-valent pneumococcal conjugate vaccine|For transplant patients, vaccination will be started at 4 months or greater after transplantation. The second dose will be given 8 weks following the frist, the third dose 8 weeks after the second, and the fourth will be given 8 weeks after the third.
16356168|NCT00212706|Drug|ONO-8025 (KRP-197)|
16356169|NCT00212693|Drug|ONO-2506PO|
16356170|NCT00212680|Drug|ONO-1101|
16356171|NCT00212667|Drug|ONO-5920|
16356172|NCT00212654|Drug|ONO-1101|
16356173|NCT00212641|Drug|ONO-5129|
16356115|NCT00213265|Biological|Pneumococcal 7-valent Conjugate Vaccine|"Healthy infants: The Prevnar schedule for healthy infants consists of 3 doses of 0.5 ml each, at approximately 2 month intervals, followed by a fourth dose of 0.5 ml at 12-15 months of age (i.e., 2, 4, 6, and 12-15 months)
~Previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, should receive the follwong schedule:
~7-11 months of age: 3 doses (2 doses at least 4 weeks apart with the third dose after the first birthday and separated from the second dose by at least two months)
~12-23 months of age: 2 doses (at least 2 months apart)
~≥24 months through 9 years of age: 1 dose"
16356116|NCT00213252|Drug|Montelukast plus prednisolone|Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast
16356117|NCT00213252|Drug|Prednisolone|Six daily doses of oral prednisolone
16356118|NCT00213239|Drug|Remifentanil|The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
16356119|NCT00213239|Drug|Remifentanil|The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
16356120|NCT00213226|Drug|dexamethasone|
16356121|NCT00213213|Drug|Sucrose|
16356122|NCT00213200|Drug|morphine, amethocaine|
16356123|NCT00213187|Behavioral|Aerobic and Qi gong Exercise|
16356124|NCT00213174|Behavioral|school playgrounds|
16356125|NCT00213161|Drug|iron supplement, iron drops|
16356126|NCT00213148|Drug|Anastrozole 1 mg|Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
16356127|NCT00213148|Drug|Anastrozole 5 mg|Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
16356128|NCT00213148|Drug|Anastrozole 10 mg|Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
16356129|NCT00213148|Drug|Clomiphene Citrate 50 mg|Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
16356130|NCT00213148|Drug|Clomiphene Citrate 100 mg|Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).
16356131|NCT00213135|Drug|Cladribine 5.25 mg/kg|Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
16356132|NCT00213135|Drug|Cladribine 3.5 mg/kg|Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
16356133|NCT00213135|Other|Placebo|Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
16356134|NCT00213122|Drug|miglitol|
16356135|NCT00213109|Drug|Miglitol|
16356136|NCT00213096|Drug|Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive|
16356137|NCT00213083|Drug|Carraguard (PC-515)|
16356138|NCT00213070|Drug|Miglitol|
16356139|NCT00213057|Drug|Carraguard (PC-515)|
16356140|NCT00213044|Drug|Carraguard (PC-515)|
16356141|NCT00213031|Drug|Carraguard (PC-515)|
16356142|NCT00213018|Drug|Carraguard (PC-515)|
16356143|NCT00213005|Drug|Carraguard (PC-515)|
16356144|NCT00212992|Procedure|fixed versus escalating biphasic defibrillation|
16356145|NCT00212979|Other|non intervention study|
16356146|NCT00212953|Procedure|Advanced Life Support|
16356147|NCT00212940|Behavioral|Supportive Therapy for Adherence to ART (behavior)|
16356148|NCT00212914|Behavioral|Reminder letter|
16356149|NCT00212901|Drug|High dose ACE-I vs ARB|
16356150|NCT00212888|Biological|Remune and ALVAC|"Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20);
~Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or
~Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20."
16356151|NCT00212875|Drug|epoetin alfa|
16356152|NCT00212862|Other|Patients with chemotherapy induced anemia|Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.
16356153|NCT00212836|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
16356154|NCT00212836|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
16356155|NCT00212823|Drug|almotriptan malate|
16356156|NCT00212810|Drug|Topiramate|
16356157|NCT00212797|Drug|Org 34517|low dose Org 34517
16356158|NCT00212797|Drug|Org 34517|high dose Org 34517
16356159|NCT00212797|Drug|Placebo|placebo
16356160|NCT00212784|Drug|asenapine|Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
16356161|NCT00212784|Drug|olanzapine|Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
16356162|NCT00212771|Drug|asenapine|Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
16356163|NCT00212771|Drug|olanzapine|Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.
16356164|NCT00212758|Drug|Nutropin AQ|Nutropin AQ
16356165|NCT00212745|Behavioral|Andrews/Reiter behavioral treatment for epilepsy|The behavioral intervention in this study uses lifestyle counseling to avoid triggers for seizures and strategies to stop beginning seizures. Participants are taught to practice meditative relaxation exercises.
16356166|NCT00212732|Drug|ONO-8025 (KRP-197)|
16356174|NCT00212628|Drug|Minodronic acid hydrate|
16356175|NCT00212615|Drug|Oxaliplatin (Eloxatin)|
16356176|NCT00212615|Drug|Capecitabine (Xeloda)|
16356177|NCT00212602|Drug|ONO-7436|
16356178|NCT00212589|Drug|Capecitabine|
16356179|NCT00212589|Drug|Fluorouracil + folinic acid|
16356180|NCT00212576|Behavioral|Video Interaction Project|While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.
16356181|NCT00212576|Behavioral|Building Blocks Project|This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.
16356182|NCT00212550|Procedure|Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.|Sputum induction
16356183|NCT00212498|Procedure|Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies|Blood sample
16356184|NCT00212485|Procedure|Power Doppler Sonography|Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.
16356185|NCT00212485|Procedure|MRI|Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.
16356186|NCT00212472|Drug|Factor VIII concentrates|To be determined at the discretion of the investigator.
16356187|NCT00212472|Other|Low-dose treatment|50 FVIII u/kg three times a week.
16356188|NCT00212472|Other|High-dose treatment|200 FVIII u/kg per day.
16356189|NCT00212459|Behavioral|Counseling|Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.
16356190|NCT00212459|Behavioral|Control|No more contacts are made with control patients after the initial counseling session.
16356191|NCT00212446|Device|Electrical Intervention (EI)|Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
16356192|NCT00212433|Drug|Tagitol V, Lo So, Readi-Cat 2|
16356193|NCT00212420|Procedure|parenteral nutrition; enteral nutrition|
16356194|NCT00212407|Biological|Umbilical Cord Blood Transplantation|
16356195|NCT00212381|Drug|di indolylmethane (DIM)|This is the agent being studies. Similar agents have been reported to have potential activity.
16356196|NCT00212381|Dietary Supplement|Red rice bran|"this will act as the active comparator. The sponsor provided this as the placebo arm since it is a filler component of their DIM capsules"
16356197|NCT00212368|Drug|Zinc acetate|
16356198|NCT00212355|Drug|NPC-02|zinc acetate
16356199|NCT00212342|Drug|Norethisterone,Ethinylestradiol|
16356200|NCT00212342|Drug|Sugar pill|
16356201|NCT00212329|Procedure|T Cell Proliferation and Autoreactivity Assays|
16356202|NCT00212329|Procedure|Cellular Immunoblot Assays|
16356203|NCT00212329|Procedure|Tetramer Studies|
16356204|NCT00212329|Procedure|Cytokine ELISPOT|
16356205|NCT00212316|Drug|sodium phenylbutyrate|
16356206|NCT00212303|Behavioral|Exercise training for 6 months|Exercise 3 times/week for 6 months. Exercise consists of aerobic and resistance exercise
16356207|NCT00212290|Drug|pioglitazone|
16356208|NCT00212290|Drug|nateglinide|
16356209|NCT00212290|Drug|placebo|
16356210|NCT00212277|Drug|Norethindrone,Ethinyl Estradiol|
16356211|NCT00212264|Behavioral|Behavioral Therapy|Pelvic Floor Muscle Exercises and Bladder control strategies
16356212|NCT00212264|Device|Pelvic Floor Electrical Stimulation|Pelvic Floor Electrical Stimulation daily for 8 weeks
16356213|NCT00212264|Behavioral|Biofeedback|Pelvic Floor Muscle training via biofeedback
16356214|NCT00212264|Other|No Treatment|No treatment
16356215|NCT00212251|Behavioral|moderate exercise and healthy, low-fat diet|
16356216|NCT00212238|Behavioral|internet behavioral weight loss program|
16356217|NCT00212212|Dietary Supplement|selenium|200 µg selenium as selenate
16356218|NCT00212212|Dietary Supplement|selenium|400 µg selenium as selenate
16356219|NCT00212212|Dietary Supplement|selenium|200 µg selenium as selenomethionine
16356220|NCT00212212|Dietary Supplement|placebo|placebo tablet
16356221|NCT00212199|Drug|orlistat|
16356222|NCT00212199|Behavioral|Brief cognitive behavioral counseling|
16356223|NCT00212186|Drug|Selenium Supplements (essential nutrient)|
16356224|NCT00212173|Drug|Sibutramine|
16356225|NCT00212173|Dietary Supplement|Slim Fast|
16356226|NCT00212160|Procedure|omentectomy|RYGB with omentectomy
16356227|NCT00212147|Drug|general anesthesia|anesthesia regimen with nitrous oxide or without nitrous oxide
16356230|NCT00212121|Radiation|high dose boost|high dose boost
16356231|NCT00212121|Procedure|boost|low dose versus high dose
16356283|NCT00211679|Drug|Botulinum Toxin Type A|
16356284|NCT00211666|Behavioral|Nurse management, home blood pressure monitors, and a chronic disease self management course.|
16356232|NCT00212108|Drug|celecoxib, gefitinib|The dose of ZD1839 to be administered is 250mg. ZD1839 will be taken once daily in the morning at approximately the same time each day. If the patient inadvertently did not take the dose in the morning, the patient may take that dose anytime up to 10pm that same day. The daily treatment will be resumed the next day at the scheduled morning dose. Celecoxib will be administered at 400 mg bd.
16356233|NCT00212095|Drug|docetaxel and ketoconazole|"Docetaxel will be obtained locally from the manufacturer. Storage conditions for unopened vials, reconstitution, and storage conditions for the reconstituted solution will follow the manufacturer's recommendations. Docetaxel solutions should be prepared and stored in glass, polypropylene or polyolefin containers. Non-PVC containing and polyethylene-lined administration sets should be used.
~Ketoconazole is available commercially in 200 mg tablet. Ketoconazole is to be administered at a dose of 200mg BID orally for six doses, starting two days before docetaxel administration. The fifth dose should be administered on the day of and before administering docetaxel, while the sixth dose should be administered in the evening of the day of docetaxel administration."
16356234|NCT00212082|Drug|doxorubicin, docetaxel|
16356235|NCT00212069|Drug|gemcitabine, carboplatin|
16356236|NCT00212056|Drug|ANP(hANP)|0∙025 μg/kg per min for 3 days(intravenous)
16356237|NCT00212056|Drug|Control|placebo
16356238|NCT00212043|Drug|carboplatin and gemcitabine|
16356239|NCT00212030|Drug|nicorandil|(0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion
16356240|NCT00212030|Drug|placebo|Control
16356241|NCT00212017|Drug|voglibose|
16356242|NCT00212017|Behavioral|diet and exercise therapy|
16356243|NCT00212004|Drug|pioglitazone|
16356244|NCT00212004|Other|control|
16356245|NCT00211991|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|
16356246|NCT00211978|Drug|calcium acetate|667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
16356247|NCT00211978|Drug|placebo|gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)
16356248|NCT00211965|Biological|S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate|single IM dose of 200 mcg total conjugate
16356249|NCT00211965|Biological|placebo|single dose IM
16356250|NCT00211952|Drug|celecoxib|
16356251|NCT00211939|Drug|calcium acetate|667 mg gelcap, 2-4 t.i.d titrated to serum phosphorus level
16356252|NCT00211939|Drug|sevelamer|1-3 tablets t.i.d, titrated to serum phosphorus level
16356253|NCT00211939|Drug|atorvastatin|20 mg PO qD (in PhosLo group), or held until D60 (sevelamer group); titrate by LDL levels and liver function tests
16356254|NCT00211926|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|single dose of vaccine containing 100 mcg of each serotype conjugate
16356255|NCT00211926|Biological|placebo|single dose of placebo
16356256|NCT00211913|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|single IM dose totalling 200 mcg of conjugate
16356257|NCT00211913|Biological|placebo|single IM dose
16356258|NCT00211900|Biological|S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine|single IM dose totalling 200 mcg of conjugate
16356259|NCT00211887|Drug|Interferon beta 1-a|The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
16356260|NCT00211887|Drug|glatiramer acetate|The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
16356261|NCT00211887|Other|placebo|an inactive substance
16356262|NCT00211874|Behavioral|Nurse-management|bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians.
16356263|NCT00211848|Drug|Polyenylphosphatidylcholine (PPC)|
16356264|NCT00211848|Drug|Pegylated Interferon|
16356265|NCT00211848|Drug|Ribavirin|
16356266|NCT00211835|Behavioral|Cognitive behavioral therapy|Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
16356267|NCT00211835|Behavioral|Supportive psychotherapy|A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
16356268|NCT00211822|Procedure|fMRI|fMRI
16356269|NCT00211809|Behavioral|Cognitive Behavioral Therapy|standard psychiatric evaluation
16356270|NCT00211809|Drug|Venlafaxine|start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
16356271|NCT00211796|Drug|Divalproex Sodium ER|
16356272|NCT00211783|Procedure|fMRI|there is no intervention
16356273|NCT00211770|Behavioral|Behavioral Assessment|functional behavioral assessments are conducted at two separate visits for each subject.
16356274|NCT00211757|Drug|Divalproex sodium|Study drug.
16356275|NCT00211757|Drug|Placebo|Placebo comparator.
16356276|NCT00211744|Drug|topiramate|
16356277|NCT00211731|Behavioral|Chronic Disease Self Management Course|
16356278|NCT00211718|Drug|intra-articular botulinum toxin type a|
16356279|NCT00211705|Behavioral|Diet|
16356280|NCT00211705|Drug|Diet+pravastatin|
16356281|NCT00211692|Drug|consensus interferon (Interferon Alfacon-1) and ribavirin|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
16356282|NCT00211692|Drug|Consensus Interferon alfa (CIFN) and ribavirin|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)
16356286|NCT00211627|Device|KEEPASLEEP enhanced breathing device|
16356287|NCT00211614|Drug|Lansoprazole|
16356288|NCT00211601|Behavioral|Disease Management Assessment|
16356289|NCT00211588|Drug|galantamine|
16356290|NCT00211575|Behavioral|Disease Management Assessment|
16356291|NCT00211562|Drug|Olanzapine, Omega 3, Vitamin E+C|No adverse event nor SAE noted.
16356292|NCT00211549|Drug|IDEA-033|
16356293|NCT00211536|Drug|Medtronic MiniMed Implantable Pump Human Recombinant Insulin|400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
16356294|NCT00211536|Device|Medtronic MiniMed Implantable Pump System|The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.
16356295|NCT00211536|Drug|Aventis HOE21PH U400|400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
16356296|NCT00211523|Drug|MBI 226 Acne Solutions|
16356297|NCT00211510|Device|Paradigm 722 sensor augmented pump|Subjects use the Paradigm 722 sensor augmented pump
16356298|NCT00211510|Device|Paradigm 715 insulin pump|Subjects use the Paradigm 715 insulin pump
16356299|NCT00211497|Drug|MBI 226 Acne Solutions|
16356300|NCT00211484|Drug|Anecortave Acetate|
16356301|NCT00211471|Drug|anecortave acetate|
16356302|NCT00211458|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
16356303|NCT00211445|Procedure|Photodynamic Therapy with Verteporfin|
16356304|NCT00211445|Drug|verteporfin|
16356305|NCT00211432|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
16356306|NCT00211419|Drug|Anecortave Acetate 15 mg|
16356307|NCT00211419|Drug|Triamcinolone Acetate 4 mg|
16356308|NCT00211419|Procedure|Photodynamic Therapy with Verteporfin|
16356309|NCT00211419|Procedure|Thermal Laser|
16356310|NCT00211406|Drug|Anecortave Acetate Sterile Suspension (15 mg)|
16356311|NCT00211393|Drug|ketoconazole|600mg. /day for 6 weeks
16356312|NCT00211380|Drug|aripiprazole|10-15 mg daily; if needed dosage may be increased to 30 mg daily after 2 weeks; maintenance 15 mg/day, periodically reassessed.
16356313|NCT00211367|Drug|Anecortave Acetate|
16356314|NCT00211354|Drug|Anecortave Acetate|ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
16356315|NCT00211341|Dietary Supplement|Vitamin A|Weekly single oral dose 7000 micrograms
16356316|NCT00211328|Drug|anecortave acetate|
16356317|NCT00211315|Drug|anecortave acetate|
16356318|NCT00211302|Drug|aripiprazole|10-15 mg/day; if needed, dosage may be increased to 30 mg/day after week 2; maintenance 15 mg/day; periodically reassessed
16356319|NCT00211289|Behavioral|Education by community pharmacist|
16356320|NCT00211276|Drug|ONTAK (denileukin diftitox)|
16356321|NCT00211263|Behavioral|Enhanced Clinical Intervention|
16356322|NCT00211263|Drug|mood stabilizer|
16356323|NCT00211250|Drug|Valproic Acid and Depakote ER|
16356324|NCT00211237|Device|Balloon Kyphoplasty|Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
16356325|NCT00211237|Other|Non Surgical Management|Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.
16356326|NCT00211224|Drug|Riluzole|
16356327|NCT00211211|Device|Balloon Kyphoplasty|
16356328|NCT00211198|Drug|ONTAK (denileukin difitox, DAB389IL-2)|
16356329|NCT00211185|Drug|Denileukin diftitox|Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.
16356330|NCT00211185|Drug|Cyclophosphamide|Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
16356331|NCT00211185|Drug|Doxorubicin|Doxorubicin will be administered IV at a dosage of 50 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
16356332|NCT00211185|Drug|Vincristine|Vincristine will be administered IV at a dosage of 1.4 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
16356333|NCT00211185|Drug|Prednisone|Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
16356334|NCT00211185|Other|Pegfilgrastim|Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm^2) for 2 days post-nadir.
16356335|NCT00211172|Behavioral|Beta-blocker adherence after an AMI|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries.
16356336|NCT00211159|Drug|EPAX 1050TG|
16356337|NCT00211146|Drug|epoetin alfa|
16356338|NCT00211133|Drug|epoetin alfa|
16356339|NCT00211120|Drug|Epoetin Alfa|
16356340|NCT00211107|Drug|Dapoxetine|
16356341|NCT00211094|Drug|Dapoxetine|
16356342|NCT00211081|Drug|Spironolactone (drug)|1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed.
16356343|NCT00211068|Drug|No intervention|This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.
16356344|NCT00211042|Other|No intervention|This is an observational study. No medication will be given to the participants. Participants will receive standard-of-care treatment from their individual physicians.
16356345|NCT00211016|Drug|doripenem|
16356346|NCT00211003|Drug|doripenem|
16356347|NCT00210990|Drug|doripenem|
16356410|NCT00210353|Drug|rituximab|rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
16356348|NCT00210977|Drug|No intervention|This is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator.
16356349|NCT00210964|Drug|ceftobiprole plus placebo|ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
16356350|NCT00210964|Drug|linezolid plus ceftazidime|linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
16356351|NCT00210951|Other|No Intervention|Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.
16356352|NCT00210938|Drug|Doripenem|
16356353|NCT00210925|Drug|topiramate|
16356354|NCT00210912|Drug|topiramate|
16356355|NCT00210899|Drug|ceftobiprole medocaril|
16356356|NCT00210899|Drug|Vancomycin plus Ceftazidime|
16356357|NCT00210886|Drug|levofloxacin|
16356358|NCT00210873|Drug|topiramate|
16356359|NCT00210860|Drug|topiramate|
16356360|NCT00210847|Drug|tramadol, acetaminophen|
16356361|NCT00210834|Drug|epoetin alfa|
16356362|NCT00210821|Drug|topiramate|
16356363|NCT00210808|Drug|topiramate|
16356364|NCT00210795|Drug|epoetin alfa|
16356365|NCT00210782|Drug|topiramate, phenytoin|
16356366|NCT00210769|Drug|paliperidone ER Oros|
16356367|NCT00210756|Drug|epoetin alfa|
16356368|NCT00210743|Drug|epoetin alfa|
16356369|NCT00210730|Drug|epoetin alfa|
16356370|NCT00210717|Drug|paliperidone palmitate|
16356371|NCT00210704|Drug|Dapoxetine|
16356372|NCT00210691|Drug|Risperidone|
16356373|NCT00210678|Behavioral|No intervention|No treatment is given to the patients as this is an observational study.
16356374|NCT00210665|Drug|Trabectedin|Type= exact number, unit= mg/m2, number= 1.5, form= intravenous infusion, route= intravenous use. 1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle
16356375|NCT00210652|Drug|RWJ 333369:|Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor
16356376|NCT00210639|Drug|No intervention|This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
16356377|NCT00210626|Drug|PROCRIT|40,000 IU/mL/week for max of 12 weeks
16356378|NCT00210626|Drug|Placebo|40,000 IU/mL/week for max of 12 weeks
16356379|NCT00210613|Drug|Dapoxetine|
16356380|NCT00210600|Drug|PROCRIT (Epoetin alfa)|
16356381|NCT00210587|Drug|epoetin alfa|
16356382|NCT00210574|Drug|topiramate|
16356383|NCT00210561|Drug|tramadol hydrochloride , acetaminophen|
16356384|NCT00210548|Drug|paliperidone palmitate|
16356385|NCT00210535|Drug|Topiramate; Placebo|
16356386|NCT00210522|Drug|RWJ 333369|Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor.
16356387|NCT00210509|Drug|almotriptan malate|
16356388|NCT00210496|Drug|topiramate; almotriptan malate|
16356389|NCT00210483|Drug|almotriptan malate|
16356390|NCT00210470|Biological|IRX-2|IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
16356391|NCT00210470|Drug|Cyclophosphamide|Single i.v. injection of low-dose (300 mg/m2) on Day 1
16356392|NCT00210470|Drug|Indomethacin|21 days of oral indomethacin, 25 mg. 3 times daily
16356393|NCT00210470|Drug|Zinc|21 days of zinc gluconate (65 mg) as part of an oral multivitamin
16356394|NCT00210470|Drug|Omeprazole|21 days of 20 mg. orally
16356395|NCT00210457|Drug|Lanreotide (Autogel formulation)|
16356396|NCT00210444|Biological|Botulinum toxin type A|
16356397|NCT00210418|Dietary Supplement|Fortified food rations|The Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ <-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat.
16356398|NCT00210418|Behavioral|Education and communication to improve feeding practices|The education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five.
16356399|NCT00210405|Dietary Supplement|"Sprinkles containing mulitple micronutrients"|
16356400|NCT00210405|Behavioral|Education/communication on use of micronutrient sprinkles|
16356401|NCT00210405|Dietary Supplement|Fortified food aid (corn-soy blend)|This intervention was part of the overall food assisted maternal and child health and nutrition program, and included fortified food aid commodities. Corn soy blend was targeted to the child, while the family also received wheat, lentils and oil.
16356402|NCT00210392|Drug|Bortezomib (drug)|Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles
16356403|NCT00210379|Drug|rituximab|
16356404|NCT00210379|Drug|CHOP|
16356405|NCT00210379|Drug|intrathecal methotrexate|
16356406|NCT00210379|Procedure|radiotherapy|
16356407|NCT00210366|Drug|Idarubicin|
16356408|NCT00210353|Drug|chlorambucil (drug)|chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
16356409|NCT00210353|Drug|rituximab+chlorambucil|rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
16356411|NCT00210340|Drug|intrathecal rituximab|
16356413|NCT00210314|Drug|high dose methotrexate|
16356414|NCT00210314|Drug|high dose cytarabine|
16356415|NCT00210314|Radiation|radiotherapy|
16356416|NCT00210301|Drug|Provigil (modafinil)|
16356417|NCT00210288|Biological|SC599|
16356418|NCT00210275|Behavioral|Printed Educational Message|Three forms of printed educational materials (short or long educational messages and patient reminder notes)
16356419|NCT00210262|Behavioral|Feedback and Education|
16356420|NCT00210236|Procedure|Conventional surgery|
16356421|NCT00210223|Procedure|Radiofrequency|
16356422|NCT00210210|Drug|Ketamine|
16356423|NCT00210197|Procedure|Blood collection (pre and postoperative): plasma coagulation parameters|
16356424|NCT00210184|Drug|Irinotecan associated to fluorouracil and leucovorin|
16356425|NCT00210171|Procedure|Toxicity : Time to progression, 1 and 2 years survival|
16356426|NCT00210158|Procedure|Nitrous oxyde|
16356427|NCT00210145|Behavioral|Aesthetic care|
16356428|NCT00210132|Drug|Ropivacaine|
16356430|NCT00210106|Device|Ablathermy|
16356431|NCT00210093|Drug|denufosol tetrasodium (INS37217)|
16356432|NCT00210080|Drug|Uridine 5'-Triphosphate (UTP) Solution for Inhalation|
16356433|NCT00210067|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
16356434|NCT00210054|Drug|denufosol tetrasodium (INS37217)|
16356435|NCT00210041|Drug|Gemcitabine|Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
16356436|NCT00210041|Drug|Cisplatin|Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
16356437|NCT00210028|Drug|Tamoxifen|
16356438|NCT00210028|Drug|Zarnestra|
16356439|NCT00210015|Drug|INS37217 Nasal Spray|
16356440|NCT00210002|Drug|Darbepoetin alfa (Aranesp®)|
16356441|NCT00210002|Drug|Ferric saccharose(Venofer®)|
16356442|NCT00209989|Drug|Zarnestra|ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.
16356443|NCT00209989|Procedure|standard Radiation therapy|Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume
16356444|NCT00209963|Drug|Gaboxadol|
16356445|NCT00209950|Drug|Gaboxadol|
16356446|NCT00209937|Drug|Gaboxadol|
16356447|NCT00209924|Drug|Gaboxadol|
16356448|NCT00209911|Procedure|cardioversion|
16356449|NCT00209898|Procedure|Fast initiation procedure|
16356450|NCT00209885|Drug|Gabapentin|
16356451|NCT00209885|Drug|S-ketamine|
16356452|NCT00209885|Drug|Lidocaine|
16356453|NCT00209885|Drug|Droperidol|
16356454|NCT00209872|Drug|Gabapentin|
16356455|NCT00209872|Drug|Lidocaine|
16356456|NCT00209872|Drug|S-ketamine|
16356457|NCT00209872|Procedure|Epidural analgesia|
16356458|NCT00209859|Drug|Methotrexate|
16356459|NCT00209859|Drug|Intraarticular betamethasone|
16356460|NCT00209859|Drug|Cyclosporine/placebo-cyclosporine|
16356461|NCT00209846|Drug|Gaboxadol|
16356462|NCT00209833|Drug|Cytarabine|
16356463|NCT00209833|Drug|Idarubicin|
16356464|NCT00209833|Drug|Etoposide|
16356465|NCT00209833|Drug|Fludarabine|
16356466|NCT00209833|Drug|G-CSF|
16356467|NCT00209833|Drug|Daunorubicine|
16356468|NCT00209820|Behavioral|Supervised Nordic Walking|
16356469|NCT00209820|Behavioral|Unsupervised Nordic Walking|
16356470|NCT00209820|Behavioral|Advice to stay active|
16356471|NCT00209807|Drug|escitalopram|escitalopram 10 mg/d for 6 weeks
16356472|NCT00209807|Drug|Reboxetine|Reboxetine 8 mg/d for 6 weeks
16356473|NCT00209807|Other|No intervention|This group of healthy volonteers will receive no drug and will be a healthy comparator.
16356474|NCT00209794|Drug|Sulfadoxine-Pyrimethamine (Fansidar)|
16356475|NCT00209781|Drug|Sulfadoxine-Pyrimethamine (Fansidar)|
16356476|NCT00209781|Device|ITNs|
16356477|NCT00209768|Device|Filter: NOE96E, ELD96E, NLF1E, TNA1E|
16356478|NCT00209755|Procedure|therapeutic drug monitoring of ribavirin and dose adaptation|
16356479|NCT00209742|Drug|UFT|P.O. everyday
16356480|NCT00209742|Drug|USEL/Leucovorin|P.O. everyday
16356481|NCT00209742|Drug|Krestin|P.O. everyday
16356482|NCT00209729|Drug|Taxotere|X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
16356483|NCT00209729|Drug|TS-1|Day 1-14, P.O. everyday
16356484|NCT00209716|Drug|Taxotere|30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
16356485|NCT00209716|Drug|5-Fluorouracil|800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
16356486|NCT00209716|Drug|Briplatin|15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
16356487|NCT00209703|Drug|Oxaliplatin|
16356488|NCT00209703|Drug|l-Leucovorin|
16356489|NCT00209703|Drug|5-Fluorouracil|
16356490|NCT00209690|Drug|Taxotere|X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16356491|NCT00209690|Drug|5-FU|800 mg/m2, CIV (conti.in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16356492|NCT00209690|Drug|Briplatin|15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16356493|NCT00209677|Drug|Gemcitabine|
16356494|NCT00209677|Drug|S-1|
16356495|NCT00209664|Drug|irinotecan|
16356496|NCT00209664|Drug|S-1|
16356497|NCT00209651|Drug|Campto, Topotesin|q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
16356498|NCT00209651|Drug|TS-1|80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
16356499|NCT00209638|Drug|irinotecan|
16356500|NCT00209638|Drug|S-1|
16356501|NCT00209625|Drug|irinotecan|
16356502|NCT00209625|Drug|leucovorin|
16356503|NCT00209625|Drug|fluorouracil|
16356504|NCT00209612|Drug|Taxol|Day1,15 X mg/m2, IV (in the vein)
16356505|NCT00209612|Drug|Campt, Topotesin|Day1,15 Y mg/m2, IV (in the vein)
16356506|NCT00209599|Drug|fospropofol disodium|
16356507|NCT00209586|Drug|fospropofol disodium|
16356508|NCT00209573|Drug|fospropofol disodium|
16356509|NCT00209560|Drug|fospropofol disodium|
16356510|NCT00209547|Drug|fospropofol disodium|
16356511|NCT00209534|Drug|fospropofol disodium|
16356512|NCT00209521|Drug|fospropofol|Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from AQUAVAN were 0.7 μg/mL (sedation) and 2.5 μg/mL (maintain anesthesia).
16356513|NCT00209521|Drug|propofol|Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from Disoprivan were 1.0 μg/mL (sedation) and 3.0 μg/mL (maintain anesthesia).
16356514|NCT00209508|Drug|GPI 1485|
16356515|NCT00209495|Drug|Pregabalin; Dexamethasone|Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
16356516|NCT00209482|Drug|glucophage XR|
16356517|NCT00209469|Drug|alendronate sodium|
16356518|NCT00209456|Drug|DatSCAN|
16356519|NCT00209443|Drug|Gadodiamide Injection|
16356520|NCT00209430|Drug|Iodixanol 320 mgI/mL|
16356521|NCT00209417|Drug|Iodixanol 320-Arm 1|
16356522|NCT00209417|Drug|Iopamidol 300-Arm 2|
16356523|NCT00209404|Drug|Iodixanol 320 mg I/Ml|
16356524|NCT00209391|Drug|Gadodiamide Injection|
16356525|NCT00209378|Other|regional anticoagulation with citrate|Regional anticoagulation with trisodium citrate is compared with standard systemic heparinization.
16356526|NCT00209378|Other|HfCitPre|regional anticoagulation with citrate containing replacement solution
16356527|NCT00209365|Procedure|exposure to grass pollen/starch granules|
16356528|NCT00209352|Drug|Acyclovir|
16356529|NCT00209339|Device|Percutaneous mitral valve repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
16356530|NCT00209326|Drug|FE200440|
16356531|NCT00209313|Drug|Acyclovir|Acyclovir 800 mg twice daily or placebo
16356532|NCT00209300|Drug|Pentasa|
16356533|NCT00209287|Behavioral|Observe patients with inactive ulcerative colitis|Observe patients with inactive ulcerative colitis
16356534|NCT00209274|Device|Percutaneous mitral valve repair using MitraClip implant|MitraClip Implant
16356535|NCT00209274|Procedure|Mitral valve repair or replacement surgery|Repair or replacement of mitral valve
16356536|NCT00209261|Drug|MINIRIN Oral Lyophilisate|
16356537|NCT00209261|Drug|Minirin tablet|
16356538|NCT00209235|Behavioral|Neurocognitive and psychosocial testing|Neurocognitive and psychosocial testing
16356539|NCT00209222|Drug|Rituximab|antibody
16356540|NCT00209222|Drug|Cyclophosphamide|chemotherapy
16356541|NCT00209222|Drug|Doxorubicin|chemotherapy
16356542|NCT00209222|Drug|Vincristine|chemotherapy
16356543|NCT00209222|Drug|Prednisone|corticosteroide
16356544|NCT00209222|Drug|Cisplatinum|chemotherapy
16356545|NCT00209222|Drug|Ara-C|chemotherapy
16356546|NCT00209222|Drug|Dexamethasone|corticosteroide
16356547|NCT00209222|Drug|BCNU|chemotherapy
16356548|NCT00209222|Drug|Melphalan|chemotherapy
16356549|NCT00209222|Drug|Etoposide|chemotherapy
16356550|NCT00209222|Drug|G-CSF|growth factor
16356551|NCT00209222|Procedure|chemotherapy: R-CHOP|immuno-chemotherapy
16356552|NCT00209222|Procedure|chemotherapy: R-DHAP|immuno-chemotherapy
16356553|NCT00209222|Procedure|chemotherapy: Dexa-BEAM|chemotherapy
16356554|NCT00209222|Procedure|stem cell harvest|procedure
16356555|NCT00209222|Procedure|total body irradiation|radiation
16356556|NCT00209222|Procedure|high-dose chemotherapy: Cyclophosphamide|chemotherapy
16356557|NCT00209222|Procedure|high-dose chemotherapy: Ara-C /Melphalan|chemotherapy
16356558|NCT00209209|Drug|Rituximab|antibody
16356559|NCT00209209|Drug|Cyclophosphamide|chemotherapy
16356560|NCT00209209|Drug|Doxorubicin|chemotherapy
16356561|NCT00209209|Drug|Vincristine|chemotherapy
16356562|NCT00209209|Drug|Prednisone|coricosteroide
16356563|NCT00209209|Drug|Fludarabine|chemotherapy
16356564|NCT00209209|Drug|Interferon-alpha|cytokine
16356565|NCT00209209|Drug|pegylated formula Interferon-alpha 2b|cytokine
16356566|NCT00209209|Procedure|chemotherapy: R-CHOP|immuno-chemotherapy
16356567|NCT00209209|Procedure|chemotherapy: R-FC|immuno-chemotherapy
16356568|NCT00209209|Procedure|Interferon maintenance|cytokine
16356569|NCT00209209|Procedure|Rituximab maintenance|antibody
16356570|NCT00209170|Behavioral|Beating the Blues|Beating the Blues is a computerized cognitive behavioral therapy.
16356571|NCT00209170|Drug|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.
16356572|NCT00209170|Drug|Placebo|A sugar pill taken as one to two tablets daily for 6 months.
16356573|NCT00209144|Drug|Intensive insulin therapy|
16356574|NCT00209131|Drug|Flomax|0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
16356575|NCT00209131|Drug|Sugar pill|Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
16356576|NCT00209118|Drug|paroxetine|
16356577|NCT00209105|Drug|DEX-CRF stimulation test|1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion
16356578|NCT00209105|Behavioral|Psychosocial stress induction|Laboratory stress induction, no drug administration
16356579|NCT00209105|Procedure|Brain imaging of sad mood , self-reference, reward|Brain imaging
16356580|NCT00209105|Behavioral|Acoustic startle|No drugs involved
16356581|NCT00209092|Drug|Docetaxel|"Sequential Therapy: Docetaxel will be given at 100 mg/m^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.
~Concurrent Therapy: Docetaxel will be given at 50 mg/m^2 IV Day 1."
16356582|NCT00209092|Drug|Capecitabine|Sequential Therapy: administration of capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
16356583|NCT00209079|Drug|Gleevec, Taxotere|Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.
16356584|NCT00209053|Procedure|Coronary Artery Bypass|
16356585|NCT00209040|Behavioral|Acoustic Startle Testing|See protocol description for methodological details
16356586|NCT00209027|Other|fMRI|fMRI scanning during behavioral reward task
16356587|NCT00209027|Drug|Aripiprazole|30 mg by mouth once daily
16356588|NCT00209014|Drug|Thalidomide|
16356589|NCT00209001|Procedure|Acupuncture|Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
16356590|NCT00209001|Procedure|Sham acupuncture therapy|Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
16356591|NCT00208988|Procedure|Educational handout about prostate cancer screening|
16356592|NCT00208988|Procedure|Simple cue for patient to talk to doctor|
16356593|NCT00208975|Drug|Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF|"Initial patients (n=9) received fludarabine (25 mg/m^2 intravenously) and mitoxantrone (10 mg/m^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8.
~After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m^2 intravenously) and cyclophosphamide (250 mg/m^2 intravenously)with sequential administration of GM-CSF (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8. All patients received additional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management."
16356594|NCT00208962|Procedure|chemotherapy and blood stem cell transplantation|A combination of conventional dose chemotherapy, granulocyte-colony stimulating factor (G-CSF) mobilized HLA-identical related allogeneic PBSC transplant, and post transplant infusions of donor leukocytes.
16356595|NCT00208949|Drug|G-CSF|G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
16356596|NCT00208949|Drug|GM-CSF|GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
16356597|NCT00208936|Drug|Taxol, Cisplatin, 5-Fluorouracil, G-CSF|
16356598|NCT00208923|Drug|Busulfan, Cyclophosphamide and Fludarabine|"Bulsufan 1mg/kg/dose P.O. every 6 hours for 4 days. If intravenous, busulfan dose will be 0.8 mg/kg every 6 hours for 16 doses.
~Fludarabine 40 mg/m2 a day for 5 days via IV over 2 hours, dose based on weight.
~Cyclophosphamide given via IV over 1 hour at dose of 60 mg/kg/day for 2 consecutive days."
16356599|NCT00208910|Behavioral|Odorant Cue|
16356600|NCT00208897|Drug|Fluoxetine|
16356601|NCT00208871|Procedure|Stereoscopic Digital Mammography|screening digital 3D mammogram
16356602|NCT00208858|Drug|Topiramate|
16356603|NCT00208832|Procedure|Graphic medication schedule (Pill card)|
16356604|NCT00208832|Procedure|Refill reminder postcard|
16356605|NCT00208819|Drug|risperidone|
16356606|NCT00208819|Drug|quetiapine|
16356607|NCT00208819|Drug|olanzapine|
16356608|NCT00208819|Drug|divalproex|
16356609|NCT00208806|Other|congestive heart failure patients|observational echo data on congestive heart failure patients
16356610|NCT00208793|Dietary Supplement|Calcium and vitamin D3 combined|Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months
16356611|NCT00208793|Drug|Placebo|Placebo
16356612|NCT00208793|Dietary Supplement|Calcium|Calcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months
16356613|NCT00208793|Dietary Supplement|Vitamin D3|Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months
16356614|NCT00208780|Drug|Tetrahydrobiopterin|
16356615|NCT00208780|Drug|Tetrahydrobiopterin|
16356616|NCT00208767|Drug|Valsartan|Valsartan was titrated to a target dose of 320 mg orally daily
16356617|NCT00208767|Drug|Placebo|A matched placebo pill will be given orally daily.
16356618|NCT00208741|Drug|Gabitril|
16356619|NCT00208728|Device|PC/SMART cardiopulmonary bypass circuit|
16356620|NCT00208728|Device|PMEA modified cardiopulmonary bypass circuit|
16356621|NCT00208728|Device|Standard of care uncoated cardiopulmonary bypass circuit|
16356622|NCT00208715|Drug|Provigil|
16356623|NCT00208702|Drug|Triiodothyronine|
16356624|NCT00208702|Other|Placebo|
16356625|NCT00208702|Drug|Sertraline|
16356626|NCT00208637|Behavioral|moderate carbohydrate, high protein diet (MCHP)|
16356627|NCT00208637|Behavioral|high carbohydrate-high fibre (HCHF) diet|
16356628|NCT00208611|Dietary Supplement|Vitamin B12 Supplementation|1000 micrograms daily
16356629|NCT00208585|Drug|sertraline|
16356630|NCT00208572|Drug|Citalopram|
16356631|NCT00208559|Drug|Ziprasidone|Ziprasidone 40mg to 60mg per day, individually titrated
16356632|NCT00208546|Drug|21Capecitabine + bevacizumab + oxaliplatin|3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1.
16356633|NCT00208546|Drug|1Capecitabine + oxaliplatin + bevacizumab + cetuximab|3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1, Ce 250 mg/m2 i.v. day 1, 8, 15 (day 1 cycle 1: 400 mg/m2).
16356634|NCT00208533|Drug|Aripiprazole|Aripiprazole 5 mg to 30mg, individually titrated
16356635|NCT00208520|Drug|Carbamazepine|
16356636|NCT00208520|Drug|Lamotrigine|
16356637|NCT00208520|Drug|Levetiracetam|
16356638|NCT00208507|Device|28 mm ceramic head on ceramic acetabular liner.|Total hip replacement with 28 mm ceramic head on ceramic liner articulation
16356639|NCT00208507|Device|28 mm ceramic head on polyethylene liner|Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.
16356640|NCT00208494|Device|Total Hip Replacement|Total hip replacement
16356641|NCT00208494|Device|Total hip replacement|Total hip replacement
16356642|NCT00208468|Device|European Hip|A cementless femoral component for use in total hip replacement
16356643|NCT00208468|Device|Zweymüller|A cementless femoral component for use in total hip replacement
16356644|NCT00208468|Device|CLS Spotorno|A cementless femoral component for use in total hip replacement
16356645|NCT00208455|Device|DePuy Proxima™ Hip|A short, anatomic, cementless femoral component for use in total hip arthroplasty
16356646|NCT00208442|Device|Marathon™|Moderately cross-linked polyethylene liner in a modular acetabular component
16356647|NCT00208442|Device|Enduron|Standard polyethylene liner in a modular acetabular component
16356648|NCT00208429|Device|Pinnacle Acetabular System|
16356649|NCT00208416|Procedure|DePuy MI System|A minimally invasive surgical technique used in total hip replacement.
16356650|NCT00208416|Procedure|Conventional surgical technique|A conventional surgical technique used in total hip replacement
16356651|NCT00208403|Device|Acryloc™ GHV|A high viscosity bone cement for use in total hip replacement
16356652|NCT00208403|Device|Palacos R|A high viscosity bone cement for use in total hip replacement
16356653|NCT00208390|Device|Summit Tapered Hip System|A cementless, tapered femoral component for use in total hip replacement
16356654|NCT00208377|Device|DePuy ASR Hip System|A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
16356655|NCT00208364|Device|Pinnacle Acetabular Cup System|A cementless acetabular cup with metal liner for use in total hip replacement
16356656|NCT00208351|Device|Ultima LX Collared Stem - Non-Polished/Blasted Finished|A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
16356657|NCT00208351|Device|Ultima LX Collared Stem - Polished Finished|A collared polished finished cementless femoral component for use in total hip replacement.
16356658|NCT00208351|Device|Ultima LX Collarless Stem - Non-Polished/Blasted Finished|A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
16356659|NCT00208351|Device|Ultima LX Collarless Stem - Polished finished|A collarless polished finished cementless femoral component for use in total hip replacement.
16356660|NCT00208338|Device|RESTORE SIS Patch|Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement
16356661|NCT00208338|Procedure|Rotator cuff repair|Standard surgical repair of torn rotator cuff
16356662|NCT00208325|Device|P.F.C Sigma Fixed Bearing total knee system|Orthopaedic implant for total knee replacement
16356663|NCT00208325|Device|P.F.C Sigma RP Mobile Bearing knee system|Orthopaedic implant for total knee replacement
16356664|NCT00208312|Drug|Regadenoson|0.4 mg, bolus intravenous injection
16356665|NCT00208312|Drug|Adenosine|0.14 mg/kg/min for 6 minutes, intravenous infusion
16356666|NCT00208299|Drug|Regadenoson|0.4 mg, bolus intravenous injection
16356667|NCT00208299|Drug|Adenosine|0.14 mg/kg/min for 6 minutes, intravenous infusion
16356668|NCT00208286|Device|PFC Sigma Fixed Bearing|PFC Sigma Fixed Bearing system for use in total knee arthroplasty
16356669|NCT00208286|Device|PFC Sigma Mobile Bearing|PFC Sigma Mobile Bearing system for use in total knee arthroplasty
16356670|NCT00208273|Drug|Letrozole - Concomitant|
16356671|NCT00208273|Drug|Letrozole - Sequential|
16356672|NCT00208260|Drug|FOLFIRI|FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
16356673|NCT00208260|Drug|FOLFOX-4|FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
16356674|NCT00208260|Drug|FOLFIRI-HD|High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
16356675|NCT00208260|Drug|FOLFOX-7|FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
16356676|NCT00208260|Drug|FOLFIRINOX|FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks
16356677|NCT00208247|Behavioral|Cognitive behavioral psychotherapy|
16356678|NCT00208234|Drug|Omalizumab|0.016 mg/kg IgE
16356679|NCT00208234|Drug|Placebo for Omalizumab|Placebo
16356680|NCT00208234|Drug|omalizumab|Monoclonal antibody against IgE. 0.016 mg/kg IgE
16356681|NCT00208221|Drug|ramipril|
16356682|NCT00208221|Drug|ramipril-telmisartan|
16356683|NCT00208208|Drug|Ziprasidone|
16356684|NCT00208195|Drug|Divalproex ER|
16356685|NCT00208182|Drug|Risperidone|
16356686|NCT00208169|Drug|Aripiprazole|
16356687|NCT00208156|Drug|Mifepristone|
16356688|NCT00208143|Drug|Quetiapine|
16356689|NCT00208143|Drug|Risperidone|
16356690|NCT00208130|Drug|Topiramate|
16356691|NCT00208117|Drug|Sertraline (Zoloft)|Patients randomized to sertraline will receive 50 mg/d for the first 6 weeks. Based on clinical response and tolerability, the dosage will be increased to 2 tablets (100 mg/d) at the end of week 6 until the end of the study (8 weeks). If adverse events occur, the dosage will be reduced by 50 mg (1 tablet) at a time, as long as a minimum daily dose of 50 mg is maintained.
16356692|NCT00208117|Drug|Simvastatin (Zocor)|The placebo drug will be administered for 8 weeks. To ensure blinding of research assessments and the patient, all medications, including the placebo, will be reformulated into a matching number of identical-appearing pills.
16356693|NCT00208104|Behavioral|Motivational Interviewing|Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial.
16356694|NCT00208091|Drug|Botulinum toxin, type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
16356695|NCT00208078|Device|pressure support ventilator|Non invasive ventilation 4h/d 5 days a week
16356696|NCT00208065|Drug|almotriptan or pseudoephedrine|
16356697|NCT00208039|Drug|Infasurf|Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria
16356698|NCT00208026|Drug|Pimecrolimus 1% Cream|Open label single arm
16356699|NCT00208000|Drug|Marine active|
16356700|NCT00207974|Drug|Marine active|
16363426|NCT00146809|Drug|Minocyline|
16356701|NCT00207948|Drug|Dose adjustment of Kaletra|Adjust the dose by up to +50% of reccomended dosa off the drug to meet target therapeutic concentrations
16356702|NCT00207935|Behavioral|Swallow instruction|
16356703|NCT00207844|Drug|Selenium as sodium selenite|
16356704|NCT00207831|Drug|Tegafur and Uracil|
16356705|NCT00207818|Device|self assembled skin substitute (SASS)|Wound care with self assembled skin substitute (SASS)
16356706|NCT00207805|Procedure|autologous PBSC transplant|optimal timining of a second autologous transplant
16356707|NCT00207792|Drug|filgrastim|
16356708|NCT00207779|Device|heparin impregnated central venous catheters|
16356709|NCT00207766|Drug|infliximab or placebo|
16356710|NCT00207753|Drug|albendazole vs. combined albendazole/ivermectin treatment|
16356711|NCT00207740|Drug|CNTO148|Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms
16356712|NCT00207740|Drug|Placebo|Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.
16356713|NCT00207727|Drug|CNTO 1275|
16356714|NCT00207714|Drug|Golimumab|Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
16356715|NCT00207714|Drug|MTX|Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
16356716|NCT00207714|Drug|Placebo|Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
16356717|NCT00207714|Drug|Infliximab|Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
16356718|NCT00207701|Drug|infliximab|
16356719|NCT00207688|Drug|Infliximab 5 mg/kg|Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
16356720|NCT00207688|Drug|Infliximab 10 mg/kg|Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
16356721|NCT00207688|Drug|Placebo|Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.
16356722|NCT00207675|Drug|infliximab|
16356723|NCT00207662|Drug|infliximab or placebo|
16356724|NCT00207649|Behavioral|Shared decision-making for PSA screening tool|Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA.
16356725|NCT00207636|Behavioral|Computer-based prostate cancer screening decision aid|
16356726|NCT00207623|Behavioral|Arthritis Basics for Change Education program|
16356727|NCT00207610|Behavioral|Daily iron supplements of 65 mg a day for 3 months|
16356728|NCT00207610|Behavioral|Universal anemia screening and treatment|
16356729|NCT00207610|Behavioral|Selective anemia screening and treatment|
16356730|NCT00207584|Drug|Doxycycline treatment|
16356731|NCT00207571|Behavioral|Computer|
16356732|NCT00207558|Drug|folic acid|
16356733|NCT00207532|Drug|folic acid|
16356734|NCT00207519|Behavioral|weekly behavioral modification group|
16356735|NCT00207519|Behavioral|liquid meal replacements|
16356736|NCT00207506|Behavioral|HoMBReS: A lay health advisor approach to STD prevention|
16356737|NCT00207493|Behavioral|Kit enhancement to referral|
16356738|NCT00207493|Procedure|patient referral versus contract referral|
16356739|NCT00207480|Behavioral|Brief, motivational interviewing intervention|
16356740|NCT00207467|Behavioral|Patient-delivered partner treatment|
16356741|NCT00207467|Behavioral|Booklet-enhanced partner referral|
16356742|NCT00207454|Behavioral|Social Cognitive Counseling|
16356743|NCT00207441|Behavioral|Arthritis Self management program|
16356744|NCT00207441|Behavioral|Chronic Disease Self Management Program|
16356745|NCT00207428|Drug|Carbamazepine|
16356746|NCT00207415|Behavioral|ASHC and CDSMP|
16356747|NCT00207402|Drug|rosiglitazone|Infergen 15mcg/ d Avandia qd Ribavirin bid
16356748|NCT00207376|Device|Solysafe Septal Occluder|
16356749|NCT00207363|Drug|Ribavirin, Peg interferon alfa 2b|Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
16356750|NCT00207363|Drug|induction therapy|Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
16356751|NCT00207350|Device|Interstitial Laser Therapy|Device
16356752|NCT00207337|Device|Exhale Drug-Eluting Stent|
16356753|NCT00207324|Device|Silver Leaf Dressing|
16356754|NCT00207311|Drug|Xenical, Pegasys, Copegus|Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.
16356755|NCT00207311|Behavioral|Xenicare Program|Xenicare program for 36 weeks.
16356756|NCT00207298|Procedure|Positron Emission Tomography|Each patient will receive an 18F-FDG PET/CT scan
16356757|NCT00207285|Behavioral|Sleep Hygiene Education|Baseline general meetings with officers in intervention districts, in which we will provide an introductory program on optimal caffeine use (caffeine re-education) and sleep hygiene, as these are cost-effective measures that may effectively address difficulties adjusting to night work, and low-grade sleep disorders such as mild shift work sleep disorder across the cohort as a whole.
16356791|NCT00207051|Drug|Brivanib + Cetuximab|Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
16356792|NCT00207025|Drug|BMS-275183|
16356793|NCT00207012|Drug|BMS-599626|
16356794|NCT00206999|Drug|imipramine|Either 50 mg of imipramine or placebo will be administered to healthy male volunteers
16356942|NCT00205660|Other|Stayers|Participants remain on their current antipsychotic.
16363497|NCT00146276|Drug|gemcitabine|
16356758|NCT00207285|Procedure|Screening and Treatment of Sleep Disorders|All individuals who screen positive in the questionnaires on the baseline survey will be referred to one of the physicians at Sleep HealthCenters® or other sleep clinics in Massachusetts. Individuals will be paid $40 for attending an initial consultation visit with a sleep clinician and $400 if they are then asked to undergo an overnight sleep study and they complete the sleep study. Individuals will also be asked to wear an ApneaLink device for 2 nights at home and for 1 night during the overnight visit at Sleep HealthCenters®. Subjects may be asked to wear the ApneaLink device for more than 2 nights if there are not 4 hours of usable data each night. If the data is inadequate, subjects will be asked to wear the device until 4 hours of usable data on 2 nights is achieved. The ApneaLink device is an FDA approved sleep-screening tool that is used to identify individuals that are at risk for Obstructive Sleep Apnea Syndrome.
16356759|NCT00207272|Behavioral|1170-1870 kcal/day liquid diet|
16356760|NCT00207272|Procedure|Gastric bypass surgery|
16356761|NCT00207272|Procedure|Biopsy.visceral adipose tissue|
16356762|NCT00207272|Procedure|Biopsy.omental adipose tissue|
16356763|NCT00207272|Procedure|Biopsy. subcutaneous abdominal adipose tissue|
16356764|NCT00207272|Procedure|Blood sample|
16356765|NCT00207259|Behavioral|Reiki & Relaxation Response Therapy with Cognitive Restructuring|"Relaxation Therapy: Practice of focus on breathing or repeated word while ignoring random thoughts without bias. Designed to lower heart rate, blood pressure and stress.
~Reiki: Practice of laying on hands by a Reiki therapist in order to channel patient's energy, considered calming and pleasant."
16356766|NCT00207233|Behavioral|MCT oil hypocaloric liquid diet|"The MCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 34 grams MCT oil (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes.
~The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study."
16356767|NCT00207233|Behavioral|LCT hypocaloric liquid diet|"The LCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day. Both diets will be isocaloric (1083 kcal/day) consisting of 38% CHO, 28% pro, 34% fat.
~The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study."
16356768|NCT00207233|Procedure|Subcutaneous abdominal adipose tissue biopsy|"Subcutaneous adipose tissue biopsies from human subjects will provide tissue samples for ex vivo analysis of adipocytokine production and cell size. Subcutaneous adipose tissue will be sampled by needle biopsy at the suprailiac crest skinfold using standard sterile technique. After a 10 cm area is isolated, cleaned and anesthetized with 1% lidocaine, a small cutaneous incision (1 cm) will be performed. A 50 cc syringe with a 19-gauge needle will be used to aspirate approximately 150 mg of adipose tissue which will require 2 to 6 passes of the needle. Sutures will be used to close the skin incision and a dry sterile dressing applied.
~This will be performed at baseline, 6 weeks, and 12 weeks."
16356769|NCT00207220|Procedure|arterial tonometry|used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
16356770|NCT00207220|Procedure|echocardiography|ultrasound test using sound waves to create a moving picture of the heart
16356771|NCT00207207|Procedure|Alternate site blood glucose testing|
16356772|NCT00207194|Behavioral|Automated Telephone Program|The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received.
16356773|NCT00207194|Behavioral|Health Behavior Education|Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
16356774|NCT00207168|Behavioral|Compliance|
16356775|NCT00207155|Drug|Cetuximab|IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.
16356776|NCT00207142|Drug|Atazanavir + 2 NRTIs|Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
16356777|NCT00207142|Drug|Atazanavir + Ritonavir + 2 NRTIs|Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
16356778|NCT00207129|Drug|Ixabepilone|Solution, I.V. infusion, 40 mg/m2, Cycles 1-18: once per cycle (Day 1) cycles 2-18 (6-54 weeks) depending on response.
16356779|NCT00207129|Drug|Capecitabine|Tablets, Oral, 1000 mg/m2, Cycle 1: Once (Day 1) Cycle 2: Twice daily (Days 1-5) Cycles 3-18: None, 2 cycles (6 weeks).
16356780|NCT00207116|Drug|Cetuximab|IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.
16356781|NCT00207103|Drug|Brivanib|Tablets, Oral, 180 mg, once daily, until disease progression
16356782|NCT00207103|Drug|Brivanib|Tablets, Oral, 320 mg, once daily, until disease progression
16356783|NCT00207103|Drug|Brivanib|Tablets, Oral, 600 mg, once daily, until disease progression
16356784|NCT00207103|Drug|Brivanib|Tablets, Oral, 800 mg, once daily, until disease progression
16356785|NCT00207103|Drug|Brivanib|Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
16356786|NCT00207103|Drug|Brivanab|Tablets, Oral, 1000 mg, once daily, until disease progression
16356787|NCT00207090|Drug|ixabepilone|ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression
16356788|NCT00207090|Drug|Rifampin|rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2
16356789|NCT00207077|Drug|Cetuximab + Erlotinib|IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.
16356790|NCT00207064|Drug|quetiapine|flexible doses according to the clinical condition
16356795|NCT00206986|Drug|clonidine|Either placebo or 25 ug, 50 uG 75 ug or 150 ug of clonidine will be added to the current medication of patients with schizophrenia, who are stable on their current medication
16356796|NCT00206986|Drug|clonidine|0.15 mg of clonidine will be administered to 20 healthy male volunteers
16356797|NCT00206973|Procedure|mannitol test|
16356798|NCT00206960|Drug|zuclopenthixol|Patients will be administered zuclopenthixol orally in doses between 4 -24 mg/day, depending on an effective reduction of symptoms
16356799|NCT00206960|Drug|risperidone|Patients will be administered risperidone orally in doses between 1-6 mg/day, depending on an effective reduction of symptoms
16356800|NCT00206947|Drug|donepezil (5-10 mg/day)|Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment
16356801|NCT00206947|Drug|Placebo|Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment
16356802|NCT00206934|Drug|Escitalopram|Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers
16356803|NCT00206934|Drug|escitaolpram|Either 15 mg of escitalopram or placebo will be administered to healthy volunteers
16356804|NCT00206921|Device|Pulsed dye laser|
16356805|NCT00206921|Device|Intense pulsed light|
16356806|NCT00206895|Procedure|Photodynamic therapy|
16356807|NCT00206882|Drug|corticosteroids|
16356808|NCT00206869|Behavioral|exercise|
16356809|NCT00206869|Behavioral|heat|
16356810|NCT00206869|Procedure|red light illumination|
16356811|NCT00206856|Device|Triage® B-Type Natriuretic Peptide (BNP) Test|
16356812|NCT00206843|Device|Triage BNP Test|
16356813|NCT00206830|Device|Triage Profiler S.O.B. Panel|
16356814|NCT00206817|Device|Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)|
16356815|NCT00206791|Device|MBCP-Gel (tm)|
16356816|NCT00206778|Drug|Lamotrigine|
16356817|NCT00206778|Drug|Sodium Valproate|
16356818|NCT00206765|Drug|Risperidone|
16356819|NCT00206765|Drug|Paroxetine|
16356820|NCT00206752|Radiation|Radiation therapy|definitive external beam radiation in the ipsilateral neck.
16356821|NCT00206752|Radiation|definitive external beam radiation in the ipsilateral neck|definitive external beam radiation in the ipsilateral neck
16356822|NCT00206739|Drug|Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)|
16356823|NCT00206726|Drug|Alemtuzumab plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
16356824|NCT00206713|Drug|Sargramostim (Leukine)|6 μg/kg sargramostim administered SC once daily for 8 weeks
16356825|NCT00206713|Drug|Placebo|Placebo administered SC once daily during the randomized retreatment phase.
16356826|NCT00206700|Drug|Sargramostim (Leukine)|Open Label, 8 week cycle
16356827|NCT00206687|Biological|Spheramine (BAY86-5280)|Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
16356828|NCT00206687|Procedure|Placebo|Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
16356829|NCT00206674|Drug|Sargramostim (Leukine)|6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
16356830|NCT00206674|Drug|Placebo|Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
16356831|NCT00206661|Drug|Sargramostim (Leukine)|4 mcg sargramostim with and without corticosteroids
16356832|NCT00206661|Drug|Sargramostim (Leukine)|6 mcg sargramostim with and without corticosteroids
16356833|NCT00206648|Drug|Betaferon/Betaseron|Betaseron 250 µg SC every other day
16356834|NCT00206648|Drug|Betaferon/Betaseron|Avonex 30 µg IM once per week
16356835|NCT00206635|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Betaseron was not administered as part of this study, only the treatment and disease status was assessed. As part of the MRI analysis Gadolinium was administered in patients who underwent this procedure
16356836|NCT00206622|Drug|Climara PRO (Estradiol / Levonorgestrel transdermal)|2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
16356837|NCT00206622|Drug|Menostar (Estradiol transdermal)|1mg 17 Beta-estradiol transdermal patch
16356838|NCT00206622|Drug|Placebo transdermal|Placebo
16356839|NCT00206609|Procedure|Oxygen and air administration|
16356840|NCT00206596|Drug|Sargramostim (Leukine)|Once daily via subcutaneous injection for up 22 weeks
16356841|NCT00206596|Drug|Placebo|Once daily via subcutaneous injection for up 22 weeks
16356842|NCT00206583|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658ID)|GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
16356843|NCT00206570|Drug|Estradiol|
16356844|NCT00206557|Drug|Raloxifene|
16356845|NCT00206557|Drug|Estradiol/dyhydroprogestrone|
16356846|NCT00206544|Drug|Tamoxifen|40 mg daily of adjunctive tamoxifen in oral capsule
16356847|NCT00206544|Drug|Progesterone|20 mg daily of adjunctive progesterone in oral capsule
16356848|NCT00206544|Other|placebo|adjunctive placebo daily in oral capsule
16356849|NCT00206518|Drug|Taxotere/Docetaxel|Taxotere
16356850|NCT00206518|Drug|Adriamycin/Cytoxan|Adriamycin/Cytoxan
16356851|NCT00206518|Drug|doxorubicin|AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
16356852|NCT00206505|Drug|Taxotere|
16356853|NCT00206492|Drug|Iressa|Iressa
16356854|NCT00206492|Drug|Tamoxifen|Tamoxifen
16356855|NCT00206466|Drug|Taxotere|Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
16356938|NCT00205699|Drug|olanzapine|randomized to begin 12 week trial of olanzapine
16356939|NCT00205699|Drug|aripiprazole|randomized to 12 week trial of aripiprazole
16356856|NCT00206466|Drug|Adriamycin/cytoxan|Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
16356857|NCT00206453|Drug|Taxotere|Chemotherapy IV
16356858|NCT00206440|Drug|esomeprazole|nexium
16356859|NCT00206440|Other|Placebo|Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5
16356860|NCT00206427|Drug|GW572016|Lapatinib, 500 mg
16356861|NCT00206427|Drug|lapatinib|Lapatinib 500 mg PO
16356862|NCT00206414|Drug|Iressa Day 1 given with Arimidex and Faslodex|timing of administration of iressa is the study factor
16356863|NCT00206414|Drug|Iressa Day 21 given with Arimidex and Faslodex|Timing of Iressa is the study factor
16356864|NCT00206401|Drug|Lantus and short acting analogs Vs NPH and short acting analogs|
16356865|NCT00206388|Drug|Zolendric acid|IV, 2mg/m2/dose on day 0
16356866|NCT00206388|Drug|Cyclophosphamide|fixed dose of 25mg/m2/dose days 0-27
16356867|NCT00206375|Drug|Growth hormone|Growth hormone + Synthroid + Lupron
16356868|NCT00206375|Drug|Growth hormone treatment and puberty|Lupron once a month and growth hormone daily
16356869|NCT00206336|Drug|Topiramate (drug)|Topiramate 25 mg to 200 mg
16356870|NCT00206323|Drug|Topiramate (drug)|Topiramate 25 mg titrated to 200 mg
16356871|NCT00206323|Drug|placebo/sugar pill|placebo
16356872|NCT00206310|Drug|CRESTOR|
16356873|NCT00206297|Drug|Pramlintide|
16356874|NCT00206284|Drug|AZD0865|
16356875|NCT00206271|Behavioral|neck collar; advice to act-as-usual; active mobilisation|
16356876|NCT00206258|Drug|Pramlintide and glucagon|
16356877|NCT00206245|Drug|AZD0865|
16356878|NCT00206232|Drug|Spironolactone|Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
16356879|NCT00206219|Drug|Gefitinib|
16356880|NCT00206219|Drug|methotrexate|
16356881|NCT00206206|Procedure|Hyperglycemia Protocol Procedure|
16356882|NCT00206193|Drug|mifepristone|
16356883|NCT00206193|Drug|misoprostol|
16356884|NCT00206193|Drug|sulprostone|
16356885|NCT00206180|Drug|esomeprazole magnesium (oral medication)|
16356886|NCT00206167|Drug|Budesonide/formoterol pMDI|
16356887|NCT00206167|Drug|Formoterol Turbuhaler|
16356888|NCT00206154|Drug|Budesonide/formoterol pMDI|
16356889|NCT00206154|Drug|Budesonide pMDI|
16356890|NCT00206154|Drug|Formoterol Turbuhaler|
16356891|NCT00206141|Drug|Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)|
16356892|NCT00206128|Drug|Seroquel SR|
16356893|NCT00206115|Drug|Seroquel Sustained Release (SR)|
16356894|NCT00206115|Drug|Seroquel Immediate Release (IR)|
16356895|NCT00206115|Drug|Placebo|
16356896|NCT00206102|Drug|quetiapine fumarate|flexible dose oral
16356897|NCT00206102|Drug|risperidone|flexible dose oral
16356898|NCT00206089|Drug|EXANTA|
16356899|NCT00206076|Drug|mycophenolate mofetil|mycophenolate mofetil and half their baseline dose of calcineurin inhibitor
16356900|NCT00206076|Drug|mycophenolate mofetil|mycophenolate mofetil monotherapy
16356901|NCT00206063|Drug|EXANTA|
16356902|NCT00206050|Drug|Esomeprazole|
16356903|NCT00206050|Drug|pantoprazole|
16356904|NCT00206037|Device|COLLOSS E|
16356905|NCT00206037|Device|TomoFix Plate|
16356906|NCT00206024|Drug|Esomeprazole magnesium (Nexium)|
16356907|NCT00206011|Procedure|Endoscopic surgery|Open surgical intervention compared to endoscopic intervention
16356908|NCT00205998|Device|Locking Compression Plate 2,4mm|
16356909|NCT00205998|Device|Locking Compression Plate 3,5mm|
16356910|NCT00205985|Device|Scaphoid screw|Conservative treatment versus application of scaphoid screw
16356911|NCT00205972|Device|Humerus Nail or LC Plate|
16356912|NCT00205959|Device|Locking proximal humerus plate|
16356913|NCT00205959|Device|Proximal Humerus Internal Locking System|
16356914|NCT00205959|Device|Proximal Humerus Nail|
16356915|NCT00205946|Drug|Bupropion|150 mg of bupropion administered 5 hours before fMRI scanning
16356916|NCT00205946|Drug|Placebo|Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
16356917|NCT00205920|Biological|BLVR Hydrogel|10 mL BLVR Hydrogel
16356918|NCT00205907|Biological|BLVR Hydrogel|10 mL BLVR Hydrogel
16356919|NCT00205894|Device|bion microstimulator|
16356920|NCT00205881|Device|HiRes 90K Bionic Ear System|Cochlear implant system
16356921|NCT00205868|Device|Precision Spinal Cord Stimulation System|Stimulation on throughout study
16356922|NCT00205855|Device|Precision SCS|Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
16356923|NCT00205842|Drug|alvimopan|
16356924|NCT00205829|Device|battery-powered bion(R) microstimulator system|Stimulation on from initial activation and on.
16356925|NCT00205816|Drug|Tigecycline|
16356926|NCT00205803|Biological|13-Valent Pneumococcal Conjugate Vaccine (13vPnC)|
16356927|NCT00205803|Biological|7-Valent Pneumococcal Conjugate Vaccine (7vPnC)|
16356928|NCT00205790|Device|Vascular graft|
16356929|NCT00205777|Drug|Bazedoxifene Acetate|BZA 20mg, daily, oral
16356930|NCT00205777|Other|Placebo|Placebo, daily, oral
16356931|NCT00205764|Drug|Melphalan|
16356932|NCT00205751|Drug|Thalidomide/Dexamethasone vs Melphalan/Prednisone|
16356933|NCT00205738|Drug|Risperidone, Olanzapine|
16356934|NCT00205725|Drug|Ziprasidone, Olanzapine|
16356935|NCT00205712|Drug|Ketamine|Ketamine without dexmedetomidine
16356936|NCT00205712|Drug|Dexmedetomidine|Ketamine plus dexmedetomidine
16356937|NCT00205699|Drug|risperidone|randomized to begin 12 week trial of risperidone
16356943|NCT00205660|Other|Switchers|Subjects are randomized to switch to aripiprazole from their current antipsychotic.
16356944|NCT00205647|Drug|Oral N-acetycystein (NAC)|
16356945|NCT00205634|Drug|Biaxin ( clarithromycin)|
16356946|NCT00205621|Device|Positron Emission Tomography|
16356947|NCT00205608|Device|Positron Emission Tomography|camera is new
16356948|NCT00205595|Device|Positron Emission Tomography|
16356949|NCT00205582|Device|Positron Emission Tomography|
16356950|NCT00205569|Behavioral|First Steps Educational Curriculum|10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration
16356951|NCT00205556|Procedure|on-line hemodiafiltration|addition of convective transport to regular dialysis treatment by using on-line hemodiafiltration
16356952|NCT00205556|Procedure|low flux hemodialysis|standard treatment
16356953|NCT00205543|Procedure|uvulopalatopharyngoplasty with or without sutures|standard UPPP
16356954|NCT00205530|Behavioral|Brain Injury Family Intervention (BIFI)|The Brain Injury Family Intervention (BIFI) was developed over the last decade based upon considerable clinical experience and research review. The BIFI is a structured approach to helping families address their most common and salient issues, concerns, and challenges. The BIFI is implemented in five 90-minute sessions.
16356955|NCT00205517|Procedure|Daily interruption of sedation versus sedation algorithm|
16356956|NCT00205504|Drug|Ortho Tri Cyclen|Ortho Tri Cyclen, one tablet daily, for 6 cycles
16356957|NCT00205491|Drug|Venlafaxine|
16356958|NCT00205478|Drug|VX-702|
16356959|NCT00205465|Drug|VX-765|
16356960|NCT00205426|Drug|Natrecor|Natrecor will be initiated as a bolus dose of 2 mcg/kg followed by a continuous infusion via infusion pump after induction of anesthesia but prior to incision. Natrecor infusion will be started at the recommended rate of 0.01mcg/kg/min. This dose may be adjusted by the investigator(s) only based on hemodynamic monitoring and pulmonary parameters. Study drug will be infused for a minimum of 24 hours and a maximum of 96 hours.
16356961|NCT00205400|Procedure|medical care delivery model|
16356962|NCT00205387|Procedure|cardiac elastography and echocardiography|standard echocardiogram
16356963|NCT00205374|Drug|Cidofovir|With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis.
16356964|NCT00205374|Drug|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
16356965|NCT00205335|Device|Ascencia Breeze Glucose meter|All study participants received glucose meter and test strips.
16356966|NCT00205335|Device|Breeze Glucose Monitor (Bayer)|Each participant received a Breeze monitor and glucose test strips.
16356967|NCT00205322|Drug|chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)|
16356968|NCT00205296|Behavioral|exercise|this will test the effect of exercise on insulin sensitivity, fitness and body composition
16356969|NCT00205283|Drug|Nelfinavir|
16356970|NCT00205270|Drug|Influenza vaccine|influenza vaccine 0.5 ml intramuscularly each season
16356971|NCT00205244|Behavioral|Healing images, relaxation and distraction materials|
16356972|NCT00205231|Drug|etanercept|
16356973|NCT00205205|Behavioral|peer mentoring|
16356974|NCT00205192|Procedure|Cardiac resynchronization pacing|various pacemaker modes used over 1 hour
16356975|NCT00205179|Drug|Novasoy|100mg/day soy isoflavones
16356976|NCT00205179|Drug|Placebo|100mg/day matching placebo
16356977|NCT00205166|Procedure|Cardiac SPECT imaging Rest and Stress|adenosine perfusion scintigraphy
16356978|NCT00205166|Drug|Caffeine|Caffeine 400 mg po
16356979|NCT00205166|Drug|Caffeine|Caffeine 200 mg po
16356980|NCT00205153|Behavioral|Pharmacy TEAM monitoring and counseling|Pharmacy team monitors and counsels patient using automatic BP monitors and special TEAM tools for assessing and improving patient adherence, barriers to adherence, lifestyle, drug therapy, BP control, and collaboration with physicians.
16356981|NCT00205127|Procedure|Cardiac PET imaging- rest and pharmacological stress|
16356982|NCT00205114|Behavioral|Individualized multifactorial intervention for community-living high-risk older adults|
16356983|NCT00205114|Behavioral|Health professional education program about fall prevention|
16356984|NCT00205062|Procedure|PET-CT|
16356985|NCT00205049|Drug|pentoxifylline|daily dosing
16356986|NCT00205023|Procedure|Sonohysterography|SHG during surgery for endometrial cancer.
16356987|NCT00205010|Procedure|Lymphoscintigraphy|
16356988|NCT00204997|Procedure|Laparoscopic ovarian transposition|Laparoscopic ovarian transposition
16356989|NCT00204984|Drug|oral hydralazine and intravenous nesiritide|vasodilators
16356990|NCT00204971|Dietary Supplement|Enteral glutamine powder|nutritional supplement
16356991|NCT00204971|Other|placebo|placebo control
16356992|NCT00204958|Drug|nutritional supplement|
16356993|NCT00204958|Drug|glutamine popsicle|
16356994|NCT00204945|Drug|nesiritide|a bolus, then infusion of nesiritide for 10-15 minutes
16356995|NCT00204932|Drug|conjugated linoleic acid|4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
16356996|NCT00204919|Drug|Vitamin D|once-monthly vitamin D oral capsules (50,000 units)
16356997|NCT00204919|Drug|placebo|once-monthly placebo capsules
16356998|NCT00204906|Dietary Supplement|vitamin D supplementation|
16356999|NCT00204893|Drug|calcium formate|Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.
16357000|NCT00204867|Other|CTC surveillance|In vivo CTC surveillance of 6-9 mm polyp
16357001|NCT00204854|Behavioral|telephone counseling|
16357002|NCT00204802|Behavioral|Patient-Centered Advance Care Planning|
16357003|NCT00204789|Drug|Difluoromethylornithine|
16357004|NCT00204776|Drug|Capecitabine and Oxaliplatin|
16357005|NCT00204763|Device|Air filled balloon catheter|The new air filled balloon catheter will be tested against the solid state catheter
16357006|NCT00204763|Device|Solid state catheter|The standardly used solid state catheter will be tested against the new air filled balloon catheter
16357007|NCT00204750|Procedure|Bougie Dilation|Bougie dilation will be performed as standard
16357008|NCT00204750|Procedure|Needle-knife incision|Needle-knife incision will be performed
16357009|NCT00204737|Drug|prednisone|20mg x 2 weeks
16357010|NCT00204737|Drug|placebo|placebo
16357011|NCT00204711|Other|SNAP II EEG System|A portable EEG monitor (SNAP II EEG System, Everest -St. Louis) is unique in that it monitors both low frequency EEG signals (1-40 Hz), which are typically used, and high frequency EEG signals (80-420 Hz), which are not usually used, and calculates a derived EEG parameter (the SNAP Index). The SNAP Index ranges from 100 (completely awake) to 0 (no brain activity) and has been shown in a few studies to correlate with increasing sedation and loss of consciousness in human volunteers and patients receiving general anesthesia during surgery.
16357012|NCT00204698|Drug|Aciphex|20 mg of aciphex taken twice daily
16357013|NCT00204685|Drug|dornase alfa|
16357014|NCT00204672|Drug|Achipex|
16357015|NCT00204659|Drug|Rituximab + CHOP chemotherapy|standard Rituximab + CHOP chemo-immunotherapy
16357016|NCT00204646|Drug|Adriamycin|
16357017|NCT00204646|Drug|Ifosfamide|
16357018|NCT00204646|Drug|Etoposide|
16357019|NCT00204646|Drug|Carboplatin|
16357020|NCT00204633|Drug|Darbepoetin alfa|
16357021|NCT00204620|Drug|Bendamustin|
16357022|NCT00204607|Biological|mRNA|
16357023|NCT00204607|Drug|GM-CSF s.c.|
16357024|NCT00204594|Drug|rM28|
16357025|NCT00204594|Drug|autologous PBMCs|
16357026|NCT00204581|Drug|Interleukin-2 (Proleukin)|6-12 MIE/d 3times a week
16357027|NCT00204568|Drug|Adriamycin|60 mg/m2, d1, W d22
16357028|NCT00204568|Drug|Trofosfamide|300 mg absolute d1-7, followed by 150 mg absolute continuously
16357029|NCT00204555|Drug|Imiquimod|
16357030|NCT00204542|Drug|Diclofenac|Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
16357031|NCT00204542|Drug|Diclofenac|Solaraze® (Diclofenac sodium) 2x/day topical for 6 months
16357032|NCT00204529|Drug|pegylated interferon-alpha-2a|
16357033|NCT00204529|Drug|interferon-alpha-2a|
16357034|NCT00204516|Biological|mRNA coding for melanoma associated antigens|mRNA vaccine s.c. applied weekly
16357035|NCT00204516|Drug|GM-CSF|Given s.c. as adjuvant drug one day after vaccine
16357036|NCT00204503|Drug|Depakote ER|
16357037|NCT00204490|Dietary Supplement|isoflavones|soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
16357038|NCT00204490|Dietary Supplement|carbohydrate|carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.
16357039|NCT00204477|Dietary Supplement|soy milk|Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.
16357040|NCT00204477|Dietary Supplement|cow's milk|Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
16357041|NCT00204464|Procedure|Exercise|
16357042|NCT00204451|Drug|0.75 levonorgestrel|
16357043|NCT00204451|Drug|50 mg ethinyl estradiol/0.5 mg levonorgestrel|
16357044|NCT00204438|Drug|0.15mg desogestrel /0.03mg ethinyl estradiol|
16357045|NCT00204425|Dietary Supplement|exercise/soy isoflavone|Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
16357046|NCT00204412|Dietary Supplement|Flax lignan|543 mg SDG per day
16357047|NCT00204412|Behavioral|Exercise (walking)|walking 45 minutes per day 5 days per week
16357048|NCT00204399|Behavioral|Telephone counseling support|
16357049|NCT00204386|Drug|Topiramate|
16357050|NCT00204373|Drug|Lansoprazole (Prevacid)|Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.
16357051|NCT00204347|Drug|risperidone|
16357052|NCT00204334|Drug|darbopoeitin|
16357053|NCT00204321|Drug|sirolimus (drug), mmf (drug)|
16357054|NCT00204308|Drug|Combination tenofovir-emtricitabine|Tenofovir disoproxil 300 mg / emtricitabine 200 mg taken as a single dose during labor
16357055|NCT00204295|Drug|O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET|
16357056|NCT00204282|Behavioral|Educational presentation, group discussion, questionnaires|
16357057|NCT00204269|Drug|Testosterone Gel Wolff|
16357058|NCT00204256|Drug|Iron sucrose|
16357059|NCT00204243|Drug|Naltrexone|surgically implanted naltrexone releasing during 5 to 6 months
16357060|NCT00204243|Drug|Methadone|Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
16357061|NCT00204230|Drug|mycophenolate mofetil (drug)|
16357062|NCT00204217|Device|endotracheal intubation|
16357063|NCT00204191|Drug|tacrolimus|
16357064|NCT00204178|Behavioral|Oxidative stress in kidney transplant recipients|
16357065|NCT00204165|Procedure|MRI of the small bowel|
16357066|NCT00204152|Behavioral|(Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation|
16357067|NCT00204139|Procedure|Routine midtrimester pregnany ultrasound scan|
16357068|NCT00204126|Device|Treadmill with partial body weight support|
16357069|NCT00204126|Device|Surface Functional Electrical Stimulation|
16357070|NCT00204113|Device|Multi-purpose rehabilitation frame|
16357071|NCT00204113|Device|Surface Functional Electrical Stimulation|
16357072|NCT00204100|Device|Surface Functional Electrical Stimulation|
16357073|NCT00204087|Behavioral|Cognitive behavioral therapy (CBT)|
16357074|NCT00204087|Behavioral|Supportive Counselling (SC)|
16357075|NCT00204074|Drug|17-beta-estradiol (drug)|
16357076|NCT00204061|Behavioral|Supportive management|The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.
16357077|NCT00204061|Drug|Amisulpride|Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
16357078|NCT00204048|Behavioral|Observation (behavior)|Inpatients admitted in GenMed at the University of Chicago will be consented to participate in an inpatient interview that consists of questions related to quality of care and satisfaction. The patient will also be interviewed over the phone 30 days after discharge and will be asked questions related to current health and their satisfaction during their stay at University of Chicago.
16357079|NCT00204035|Behavioral|Evaluation (behavior)|TEACH is a precollege enrichment program for highschool students to encourage and promote these students towards careers in clinical research. To accomplish this, instruments designed to evaluate the knowledge, attitudes, and behaviors are administered during their participation in the TEACH program.
16357080|NCT00204022|Drug|Mycophenolate mofetil|Mycophenolate mofetil
16357081|NCT00204022|Drug|Azathioprine|Azathioprine
16357082|NCT00204009|Behavioral|Disease Surveillance, Family Studies, Questionnaire Followup|
16357083|NCT00203996|Device|continuous positive airway pressure (CPAP)|CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open during sleep so that you can breathe normally. The pressure acts much in the same way as a splint and holds the airway open.
16357084|NCT00203996|Drug|depot leuprolide plus estrogen/progestin replacement|Depot leuprolide is a long-acting, modified version of the natural brain hormone, gonadotropin releasing hormone (GnRH). This study drug will temporarily reduce the pituitary hormones that stimulate the ovaries to make both female (estrogen) and male (testosterone) hormones. The effect of this study drug will last approximately 12 weeks. During this time, your female hormone levels will be brought to normal by the use of a patch that contains estrogen and progesterone. This patch is placed on the skin and is changed twice a week. The subject will continue to wear this patch for 4 weeks after the end of the study, until the effects of the Lupron injection wear off.
16357085|NCT00203996|Drug|pioglitazone|Pioglitazone (Actos). Pioglitazone is an oral medication approved in the Unites States for the treatment of patients with type 2 diabetes (however it is not approved for studies in this protocol). This is one of a class of drugs known as thiazolidinediones. This class of drugs has been associated with potential beneficial changes in the metabolism (use of glucose by the body) as well as lipids (fats) in the blood.
16357086|NCT00203996|Procedure|REM frag|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
16357087|NCT00203996|Procedure|SWS supp|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
16357088|NCT00203970|Behavioral|Observation|Using a data abstraction form, we wish to gather the following information: 1) Patient demographics 2) identity of the attending, residents, and interns caring for the patient 3)whether the patient had any absolute or relative contraindications for receiving LMWH 4) how the patient was treated for his/her condition
16357089|NCT00203957|Drug|Istradefylline|Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
16357090|NCT00203957|Drug|Istradefylline|Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
16357091|NCT00203944|Behavioral|Behavioral, Development|
16357092|NCT00203931|Drug|Cetuximab|
16357093|NCT00203931|Drug|Pemetrexed|
16357094|NCT00203918|Behavioral|Survey, interview|A survey is administered to patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand patients' individual evaluations of treatment-related health states. Medical records will also be reviewed 00 days after the survey was administered to determine whether this data reflects actual treatment decisions.
16357095|NCT00203918|Behavioral|patient utility scores (i.e. patient preference weights)|comparison of patient preferences
16357096|NCT00203905|Drug|5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab|Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
16357097|NCT00203905|Drug|5-Fluorouracil, Hydroxyurea-[FHX]|Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
16357098|NCT00203892|Biological|modified CEA peptide (10mcg)|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
16357099|NCT00203892|Biological|modified CEA peptide (100mcg)|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
16357100|NCT00203892|Biological|modified CEA peptide (1000mcg)|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
16357101|NCT00203879|Drug|MAGE-3/Melan-A/gp100/NA PBMC, rhIL-12 (drug)|draft
16357102|NCT00203879|Drug|MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2|MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2
16357103|NCT00203866|Drug|G250 peptide|
16357104|NCT00203866|Drug|IL-2|
16357105|NCT00203853|Device|pillbox, wristwatch|
16357106|NCT00203814|Drug|Sulfadoxine-pyrimethamine|
16357107|NCT00203814|Drug|Artesunate plus sulfadoxine-pyrimethamine|
16357108|NCT00203801|Drug|Sulfadoxine-pyrimethamine|
16357109|NCT00203801|Drug|Artesunate plus sulfadoxine-pyrimethamine|
16357110|NCT00203801|Drug|Artemether-lumefantrine|
16364103|NCT00141128|Drug|SS-RBX|
16357111|NCT00203788|Behavioral|Individual Placement and Support|Supported education/employment
16357112|NCT00203788|Behavioral|Workplace Fundamentals Module|Group skills training on job/school topics
16357113|NCT00203788|Behavioral|Brokered Vocational Rehabilitation|Vocational rehabilitation through traditional separate state-funded agency
16357114|NCT00203788|Drug|Oral risperidone|Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
16357115|NCT00203788|Behavioral|Skills training group|Group social skills training that did not focus primarily on work situations
16357116|NCT00203775|Drug|risperidone|
16357117|NCT00203762|Behavioral|Public sector antiretroviral treatment programmes|
16357118|NCT00203749|Behavioral|Community-Based HIV VCT|"COMMUNITY MOBILIZATION. This component of the intervention uses community outreach to enhance the uptake of VCT, thus increasing the rate of HIV testing and frequency of discussions about HIV and reducing stigma through community education and mobilization.
~EASY ACCESS TO VCT. This component is designed to remove practical barriers and increase safety of VCT. Mobile vans or temporary units set up at local community sites will provide free, anonymous VCT in specific, chosen sites where people gather, such as market areas, shopping centers, and community centers.
~POST-TEST SUPPORT SERVICES. This component is designed to build psychosocial support to improve the quality of life for individuals diagnosed with HIV. The expected outcomes include a reduction in social harm, an increase in social support through disclosure to those most likely to provide support, and a reduction in internalized stigma. Social support should also decrease the behavioral risk of further transmission."
16357119|NCT00203749|Behavioral|Standard clinic-based VCT|Control communities will receive Standard Clinic-Based VCT (SVCT) instead of the community-based VCT (CBVCT) intervention. Each of these communities will have access to SVCT that reflects local access to health care. The training for VCT counselors will be the same in the CBVCT and SVCT communities; however, no active recruitment for participation in the SVCT services will be made beyond the standard procedures of each clinic for informing patients of services (e.g., telling individual patients that VCT is available, posting of a flyer in the clinic announcing VCT availability, etc). As such, no active outreach or community mobilization will be conducted by the study staff in the SVCT settings (although it is possible that such activities will occur due to local initiative).
16357120|NCT00203736|Drug|Sulfadoxine-pyrimethamine|
16357121|NCT00203736|Drug|Artesunate plus sulfadoxine-pyrimethamine|
16357122|NCT00203723|Drug|Risperidone|
16357123|NCT00203710|Device|Concentric Retriever Device|
16357124|NCT00203697|Drug|minocycline|
16357125|NCT00203684|Drug|Flunisolide-HFA|
16357126|NCT00203658|Drug|Tinzaparin sodium|
16357127|NCT00203645|Behavioral|Self-help treatment|"Workbook Becoming a Winner,"
16357128|NCT00203632|Drug|rosiglitazone/placebo|
16357129|NCT00203619|Device|Wireless capsule endoscopy|wire less capsule endoscopy
16357130|NCT00203619|Other|standard care|standard diagnostic evaluation as decided by treating physician
16357131|NCT00203606|Drug|pegylated interferon alfa-2a ( Roche) and ribavirin|pegylated interferon alfa-2a ( Roche) and ribavirin
16357132|NCT00203593|Behavioral|Exercise|
16357133|NCT00203593|Device|Blood volume|
16357134|NCT00203593|Procedure|VO2max test|
16357135|NCT00203593|Procedure|Lower body negative pressure|
16357136|NCT00203593|Behavioral|Heart Rate|
16357137|NCT00203593|Procedure|Blood Pressure|
16357138|NCT00203593|Behavioral|Total Peripheral Resistance|
16357139|NCT00203580|Drug|Tinzaparin sodium|
16357140|NCT00203567|Drug|carbamazepine ER|Active study drug, no comparator
16357141|NCT00203554|Genetic|Poly methylmetacrylate, PMMA|
16357142|NCT00203541|Device|TELFA™ A.M.D. Island dressing|
16357143|NCT00203528|Drug|divalproex sodium ER|
16357144|NCT00203528|Drug|risperidone|
16357145|NCT00203515|Device|Standard Latex Foley Catheter|
16357146|NCT00203515|Device|Silver Coated Latex Foley Catheter|
16357147|NCT00203502|Drug|Bevacizumab|IV 15mg/kg 21 days
16357148|NCT00203502|Drug|Cyclophosphamide|500mg per meter squared, IV every 21 days
16357149|NCT00203502|Drug|Docetaxel|60 mg per meter squared, IV every 21 days
16357150|NCT00203489|Device|KERLIX A.M.D. Gauze|
16357151|NCT00203476|Drug|Niacin|
16357152|NCT00203476|Drug|Colestipol|
16357153|NCT00203476|Drug|Ezetimibe|
16357154|NCT00203463|Drug|topiramate|
16357155|NCT00203450|Drug|Zonegran|zonisamide
16357156|NCT00203450|Drug|Placebo|Placebo pill
16357157|NCT00203424|Drug|Erlotinib + Bevacizumab|Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
16357158|NCT00203411|Drug|Capecitabine (Xeloda)|1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period
16357159|NCT00203411|Drug|Bevacizumab|7.5 mg/kg IV will be administered every 3 weeks
16357160|NCT00203385|Drug|Divalproex|Depakote up to 2000mg/d
16357161|NCT00203372|Drug|Bevacizumab 7.5 and TAC|Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
16357162|NCT00203372|Drug|Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)|placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
16357163|NCT00203372|Drug|Bevacizumab 15 and TAC|one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
16357164|NCT00203372|Drug|Placebo 15 and TAC|one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.
16357165|NCT00203359|Drug|etanercept given by perispinal administration|
16357166|NCT00203346|Procedure|Greater Occipital Nerve Block|
16357167|NCT00203333|Device|Medtronic REVEAL|
16357168|NCT00203320|Drug|etanercept given by perispinal administration|
16357169|NCT00203307|Drug|Olanzapine during first intervention period and placebo during second intervention period|Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period)
16357170|NCT00203307|Drug|Placebo during first intervention period, then olanzapine during second intervention period|Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).
16357171|NCT00203294|Drug|lidocaine, bupivicaine and saline|lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
16357172|NCT00203294|Drug|lidocaine plus bupivicaine plus triamcinolone (steroid)|lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
16357173|NCT00203281|Drug|tacrolimus|
16357174|NCT00203281|Drug|mycophenolate mofetil|
16357175|NCT00203281|Drug|daclizumab|
16357176|NCT00203281|Drug|intravenous immune globulin|
16357177|NCT00203281|Procedure|plasmapheresis|
16357178|NCT00203268|Drug|dihydroergotamine mesylate|1.0 mg. intramuscularly
16357179|NCT00203255|Drug|Soy Isoflavones|
16357180|NCT00203242|Drug|Depacon IV and Depakote ER|
16357181|NCT00203229|Drug|lamotrigine|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication.
16357182|NCT00203229|Drug|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
16357183|NCT00203216|Drug|levetiracetam|Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)
16357184|NCT00203216|Procedure|Transcranial Magnetic Stimulation|
16357185|NCT00203203|Device|Intramyocardial Injection of stem cells via NOGA Mapping|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.
16357186|NCT00203203|Other|Control, then Stem Cell Therapy|Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
16357187|NCT00203190|Drug|Topiramate|
16357188|NCT00203177|Drug|rasagiline mesylate|0.5 rasagiline mesylate
16357189|NCT00203177|Drug|rasagiline mesylate 1.0 mg|1.0 mg rasagiline mesylate
16357190|NCT00203164|Drug|rasagiline mesylate|rasagiline mesylate 1 mg oral once daily
16357191|NCT00203151|Drug|edratide|0.5 mg, 1.0 mg, 2.5 mg injection once weekly
16357192|NCT00203138|Drug|rasagiline mesylate|
16357193|NCT00203125|Drug|rasagiline mesylate|0.5 or 1 mg oral, once-daily
16357194|NCT00203125|Other|tyramine|50 mg once daily
16357195|NCT00203112|Drug|glatiramer acetate with minocycline|Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
16357196|NCT00203112|Drug|Glatiramer acetate with placebo|Subcutaneous injection glatiramer acetate 20mg, with oral placebo
16357197|NCT00203099|Drug|Glatiramer Acetate, N-Acetylcysteine|Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
16357198|NCT00203073|Drug|glatiramer acetate 20 mg|glatiramer acetate 20 mg
16357199|NCT00203073|Drug|glatiramer acetate 20 mg, with mitoxantrone|glatiramer acetate 20 mg, with mitoxantrone
16357200|NCT00203060|Drug|Rasagiline Mesylate|tablet, 1 or 2 mg, daily, 58 weeks
16357201|NCT00203060|Drug|placebo|tablet, once daily, 58 weeks
16357202|NCT00203047|Drug|Glatiramer Acetate|20mg glatiramer acetate (GA) administered by daily subcutaneous injections
16357203|NCT00203047|Drug|Placebo|Placebo for prednisone given daily
16357204|NCT00203047|Drug|Prednisone|Prednisone 1250 mg taken daily
16357205|NCT00203034|Drug|rasagiline mesylate|0.5 mg rasagiline mesylate oral once daily
16357206|NCT00203034|Drug|1.0 mg rasagiline mesylate|1.0 mg rasagiline mesylate oral once daily
16357207|NCT00203034|Other|Placebo|oral placebo once daily
16357208|NCT00203021|Drug|Glatiramer acetate|Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
16357209|NCT00202995|Drug|Glatiramer Acetate|20 mg s.c. daily
16357210|NCT00202995|Drug|Betaseron|250 mg every other day
16357211|NCT00202995|Drug|Rebif|44 ug 3 times a week
16357212|NCT00202982|Drug|glatiramer acetate 20 mg|glatiramer acetate 20 mg
16357213|NCT00202982|Drug|glatiramer acetate 40 mg|glatiramer acetate 40 mg
16357214|NCT00202969|Drug|S-1|S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
16357215|NCT00202969|Drug|S-1 plus CDDP|S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.
16357216|NCT00202969|Drug|5-FU plus CDDP|5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.
16357217|NCT00202956|Drug|Bugusan|
16357218|NCT00202943|Procedure|TCRFVR and LAUP|
16357219|NCT00202930|Drug|anti-CD20 (Rituximab)|4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22
16357220|NCT00202917|Drug|Fludarabine|
16357221|NCT00202917|Drug|Thiotepa|
16357222|NCT00202917|Drug|Melphalan|
16357223|NCT00202917|Drug|OKT-3|
16357224|NCT00202917|Procedure|CD3/CD19 depletion on CliniMACS|
16357225|NCT00202904|Drug|ezetimibe|ezetimibe 10 mg tablets, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks
16357226|NCT00202904|Drug|placebo|placebo tablets matched to ezetimibe, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks
16357227|NCT00202891|Drug|sisomicin|
16357228|NCT00202878|Drug|ezetimibe/simvastatin|Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
16357274|NCT00202475|Procedure|whole blood collection|collection of whole blood
16357275|NCT00202462|Drug|Testosterone gel|Testosterone gel 7.5 gm qd
16357698|NCT00199017|Procedure|CNS irradiation|
16357229|NCT00202878|Drug|simvastatin|Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
16357230|NCT00202878|Drug|Placebo for simvastatin 40 mg|one or two tablets orally daily
16357231|NCT00202878|Drug|Placebo for ezetimibe 10 mg/simvastatin 40 mg combination|one tablet orally daily.
16357232|NCT00202865|Biological|infliximab|Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
16357233|NCT00202865|Biological|Placebo|Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
16357234|NCT00202852|Other|Placebo|Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
16357235|NCT00202852|Drug|MTX|Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week
16357236|NCT00202852|Biological|Infliximab|Infliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX
16357237|NCT00202852|Drug|MTX|3 mg/kg infliximab infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week
16357238|NCT00202839|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program
16357239|NCT00202839|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program
16357240|NCT00202839|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program
16357241|NCT00202839|Drug|Ribavirin|200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program
16357242|NCT00202826|Procedure|Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage|
16357243|NCT00202813|Device|Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter|
16357244|NCT00202800|Drug|Gemcitabine, Etoposide|Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer
16357245|NCT00202787|Drug|FOLFOX-4+cetuximab|"Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);
~FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2"
16357246|NCT00202787|Drug|FOLFOX-4|FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2
16357247|NCT00202774|Drug|(capecitabine, oxaliplatin, 5-fluorouracil)|
16357248|NCT00202761|Behavioral|PIH|Intensified training
16357249|NCT00202748|Behavioral|Increase in activity to control weight|
16357250|NCT00202748|Behavioral|Increase in activity to control weight.|
16357251|NCT00202735|Procedure|Arm1:Immobilization in external rotation|Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation.
16357252|NCT00202735|Procedure|immobilization in internal rotation|All the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device.
16357253|NCT00202722|Drug|Remifentanil|Intravenous patient controlled analgesia (ivpca) during labour
16357254|NCT00202709|Behavioral|Thought Field Therapy (TFT)|Treatment with TFT twice in one week
16357255|NCT00202696|Drug|nalmefene|Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).
16357256|NCT00202696|Other|Placebo|Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).
16357257|NCT00202657|Procedure|echocardiography|
16357258|NCT00202644|Drug|Anagrelide|Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
16357259|NCT00202644|Drug|Hydroxyurea|Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
16357260|NCT00202631|Device|Surface Functional Electrical Stimulation|
16357261|NCT00202618|Drug|Valsartan|
16357262|NCT00202618|Drug|Amlodipine|
16357263|NCT00202605|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate|
16357264|NCT00202592|Drug|Perindopril|
16357265|NCT00202579|Drug|Ivabradine|
16357266|NCT00202566|Drug|Ivabradine|
16357267|NCT00202553|Drug|Perindopril|
16357268|NCT00202540|Drug|S18986|
16357269|NCT00202527|Device|Nasal continuos positive airway pressure|
16357270|NCT00202514|Drug|divalproex sodium extended release|
16357271|NCT00202501|Device|Nasal CPAP (Continuous Positive Airway Pressure)|
16357272|NCT00202488|Drug|H. pylori treatment|
16357273|NCT00202475|Procedure|eythrocytapheresis|machinal collection of erythrocytes
16357276|NCT00202449|Drug|prazosin|taken by mouth, twice daily, titrated up to efficacy or a maximum of 5 mg at 10a and 25 mg at bedtime for duration of study
16357277|NCT00202449|Drug|paroxetine|20 mg taken at 10a for duration of the study
16357278|NCT00202449|Drug|Placebo|Placebo
16357279|NCT00202436|Procedure|Phlebotomy|Removal of 500 ml whole blood
16357280|NCT00202436|Procedure|Erythrocytapheresis|machinal removal of erythrocytes
16357281|NCT00202423|Drug|Sativex|
16357282|NCT00202410|Biological|Bacille of Calmette-Guerin|A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).
16357283|NCT00202410|Other|placebo|subcutaneous administration of physiologic solution
16357284|NCT00202397|Drug|Riluzole|capsule-shaped 50 mg tablets bid for 8 weeks
16357285|NCT00202397|Other|placebo|capsule-shaped tablet bid for 8 weeks
16357286|NCT00202371|Procedure|Red Blood Cell transfusion|
16357287|NCT00202358|Drug|atenolol|
16357288|NCT00202358|Drug|placebo|
16357289|NCT00202345|Drug|Iron sucrose|
16357290|NCT00202332|Procedure|Coronary artery bypass|
16357291|NCT00202319|Procedure|Sedation management protocol|
16357292|NCT00202306|Drug|lithium carbonate|
16357293|NCT00202293|Drug|Olanzapine|
16357294|NCT00202293|Drug|Lithium|
16357295|NCT00202293|Drug|Chlorpromazine|
16357296|NCT00202280|Drug|Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg|
16357297|NCT00202267|Device|Four-layer Bandage (Elastomeric)|Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
16357298|NCT00202267|Device|Short-stretch Bandage (Non-elastomeric)|These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
16357299|NCT00202254|Behavioral|Physiotherapy|
16357300|NCT00202254|Behavioral|Occupational therapy|
16357301|NCT00202254|Behavioral|Speech pathology|
16357302|NCT00202241|Procedure|testosterone injection|
16357303|NCT00202228|Drug|cofactor supplementation (thiamine, riboflavin, L-carnitine)|Thiamine: 50 mg po od; Riboflavin: 100 mg po od; L-carnitine: 990 mg po bid.
16357304|NCT00202215|Behavioral|Chrysalis Day Program|
16357305|NCT00202202|Procedure|consultation format|
16357306|NCT00202189|Drug|Budesonide|Nebulized Budesonide (4 mL) or saline solution (0.9% NaCl) (4 mL) will be administered to subjects once only.
16357307|NCT00202176|Drug|Ipratropium Bromide|Nebulized Ipratropium Bromide (4 mL) or saline solution (0.9% NaCl) (4mL) will be administered to subjects once only.
16357308|NCT00202163|Drug|DHEA|
16357309|NCT00202163|Drug|Testosterone|
16357310|NCT00202150|Behavioral|Application of a management action plan|
16357311|NCT00202137|Behavioral|Home blood pressure monitoring|Monitor blood pressure using home blood pressure monitor
16357312|NCT00202137|Behavioral|Physician monitoring of blood pressure|Blood pressure measured as standard care from physician (no home monitor given for blood pressure monitoring)
16357313|NCT00202124|Drug|Tryptophan|
16357314|NCT00202111|Procedure|Laparoscopic-assisted colectomy|
16357315|NCT00202111|Procedure|Conventional open colectomy|
16357316|NCT00202098|Procedure|Variable ventilation|"Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and traditional CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period the investigators will record the gas exchange parameters and the mechanics of the respiratory system."
16357317|NCT00202059|Drug|Zoledronic acid|
16357318|NCT00202059|Behavioral|Physical activity intervention|
16357319|NCT00202033|Behavioral|frequency of self monitoring blood glucose|Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
16357320|NCT00202020|Drug|Cilostazol 200mg/day Oral|
16357321|NCT00202020|Drug|Aspirin 100mg/day Oral|
16357322|NCT00202007|Drug|Aripiprazole tablet, 5-30mg/day, oral, 6 weeks|
16357323|NCT00202007|Drug|Risperidone tablet, 1-6mg/day, oral, 6 weeks|
16357324|NCT00201994|Drug|Tolvaptan|
16357325|NCT00201981|Drug|Rebamipide|"OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
~OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks"
16357326|NCT00201968|Device|Compex Motion Stimulator|Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
16357327|NCT00201968|Device|Compex Motion Stimulator|Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
16357328|NCT00201968|Other|Conventional Exercise|An aerobic and resistance training program.
16357329|NCT00201955|Drug|Rebamipide|
16357330|NCT00201942|Procedure|PET scan|
16357331|NCT00201929|Procedure|Standard Decision Board|
16357332|NCT00201929|Procedure|Computer Decision Board|
16357333|NCT00201929|Procedure|Paper Decision Board|
16357334|NCT00201916|Procedure|5250 cGy/20 fractions over 28 days|see above
16357335|NCT00201916|Procedure|6600 cGy/33 fractions over 45 days|see above
16357336|NCT00201890|Procedure|Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)|20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
16357337|NCT00201877|Drug|Velcade|"Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14.
~Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23."
16357338|NCT00201877|Drug|Rituximab|"Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration.
~Maintenance: 375 mg/m2 day 1 weekly x 4 weeks."
16357339|NCT00201864|Drug|Exemestane|25 mg orally per day
16357340|NCT00201864|Drug|Fulvestrant|250 mg IM starting on Day 8 and then every 28 days.
16357341|NCT00201851|Drug|Tamoxifen|20 mg po daily x 5 years
16357434|NCT00201006|Other|Mail contact|Biweekly written newsletters with weight management advice delivered via U.S. mail
16357342|NCT00201851|Procedure|Surgery: Oophorectomy|Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
16357343|NCT00201838|Drug|Gemcitabine|The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.
16357344|NCT00201838|Drug|Etanercept|Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.
16357345|NCT00201825|Drug|Capecitabine|1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
16357346|NCT00201825|Drug|Docetaxel|36 mg/m2 IV weekly for 3 weeks every 4 weeks.
16357347|NCT00201812|Drug|Etanercept|7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
16357348|NCT00201812|Drug|Docetaxel|Administered intervenously (IV) over 30 minutes through an infusion pump once a week (every 7 days). A cycle will comprise six weekly treatments followed by 2 weeks of rest.
16357349|NCT00201812|Drug|Dexamethasone|Administered orally 8 mg 12 hours prior to docetaxel, immediately prior to docetaxel (two hours after etanercept), and 12 hours after docetaxel to complete a total of 3 doses (total dose 24 mg/week) on treatment weeks.
16357350|NCT00201799|Drug|Infliximab|"A total of 6 doses of Infliximab will be administered as follows:
~Dose 1: 10 mg/kg IV one day prior to commencing the myeloablative preparative regimen Dose 2: 10 mg/kg IV on day 0 to be given after peripheral blood stem cell infusion Dose 3: 10 mg/kg IV on day +7 Dose 4: 10 mg/kg IV on day +14 Dose 5: 10 mg/kg IV on day +28 Dose 6: 10 mg/kg IV on day +42"
16357351|NCT00201786|Drug|Pentostatin|Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
16357352|NCT00201773|Drug|Exemestane|25 mg orally once per day for 16 weeks.
16357353|NCT00201773|Drug|Celecoxib|given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
16357354|NCT00201773|Other|Correlative studies|
16357355|NCT00201760|Drug|Gemcitabine|1000 mg/m2 IV over 30 minutes on Days 1 and 8.
16357356|NCT00201760|Drug|Trastuzumab|2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
16357357|NCT00201760|Drug|Cisplatin|30 mg/m2 IV on Day 1 and Day 8.
16357358|NCT00201747|Drug|CPT-11|CPT-11 will be administered intravenously on days 2 and 9 (24 hours after MMC, when the MMC is required) Two weeks of rest (beginning days 15 and 22) (drug free) will complete the cycle, with therapy planned to be resumed on day 29.
16357359|NCT00201747|Drug|Mitomycin C|MMC will be administered intravenously on day 1 (Arm A) and days 1 and 8 (Arm B)
16357360|NCT00201734|Drug|Capecitabine|Level 1: 500 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 2: 750 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 3 - 5: 1000mg/m2 orally twice daily Days 8 - 21 of each cycle.
16357361|NCT00201734|Drug|Carboplatin|Levels 1-5: AUC of 6 every 4 weeks.
16357362|NCT00201734|Drug|Paclitaxel|Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.
16357363|NCT00201721|Drug|Pentostatin|2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.
16357364|NCT00201721|Drug|Rituximab|For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.
16357365|NCT00201721|Drug|Cyclophosphamide|600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6
16357366|NCT00201708|Drug|Docetaxel|Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.
16357367|NCT00201708|Drug|Doxorubicin|60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide)
16357368|NCT00201708|Drug|Cyclophosphamide (AC)|600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide)
16357369|NCT00201695|Drug|Doxil®|40 mg/m2 IV day 1
16357370|NCT00201695|Drug|Vincristine|1.4 mg/m2 (maximum 2 mg) IV day 1
16357371|NCT00201695|Drug|Dexamethasone|40 mg PO days 1-4
16357372|NCT00201695|Drug|Arsenic Trioxide|0.25 mg/kg IV over 1-4 hours twice per week, week 1-4 of each cycle (i.e., days 1 and 4; 8 and 11; 15 and 18; 22 and 25)
16357373|NCT00201682|Drug|Etanercept|25 mg SQ twice weekly weeks 1-5
16357374|NCT00201682|Drug|Rituximab|(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5
16357375|NCT00201669|Drug|Clofarabine|Clofarabine 30 mg/m2/day will be administered as a 2-hour intravenous infusion (IVI) on days 1-5.
16357376|NCT00201656|Procedure|Retention of Cerclage|Retain Cerclage until clinical removal is indicated by protocol
16357377|NCT00201656|Procedure|Removal of Cerclage|Immediate removal of Cerclage following randomization
16357378|NCT00201656|Procedure|Removal vs. Retention of Cervical Cerclage|Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress
16357379|NCT00201643|Drug|Betamethasone or Dexamethasone (2nd course of ACS)|Course of Betamethasone or Dexamethasone
16357380|NCT00201643|Drug|Placebo|Course of Placebo (NS)
16357381|NCT00201630|Drug|Uroxatrol (drug)|
16357382|NCT00201617|Device|Bone-anchored hearing aid|
16357383|NCT00201591|Behavioral|Exercise training for 10 weeks|
16357384|NCT00201552|Drug|Statin|
16357385|NCT00201539|Drug|single dose Morphine|
16357386|NCT00201539|Drug|double dose Morphine|
16357387|NCT00201539|Drug|placebo|purchased from the manufacturer of morphine tablets (Nycomed Pharma, Oslo, Norway)
16357435|NCT00200993|Behavioral|physical activity|
16357388|NCT00201513|Behavioral|Isolated Transversus abdominis (TrA) exercise|Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
16357389|NCT00201513|Behavioral|sling exercise|Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
16357390|NCT00201513|Behavioral|group exercise|Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback
16357391|NCT00201461|Device|STARFlex septal closure system|transcatheter placement of STARFlex device to close a patent foramen ovale
16357392|NCT00201461|Drug|Best medical therapy|aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
16357393|NCT00201448|Biological|Hepatitis A Vaccine|Single dose give IM
16357394|NCT00201448|Biological|Towne CMV Vaccine|Single dose given subcutaneously
16357395|NCT00201435|Drug|Paclitaxel weekly in combination with capecitabine|
16357396|NCT00201435|Drug|Docetaxel every 3 week in combination with capecitabine|
16357397|NCT00201422|Other|Omeprazole, Amoxicillin, Clarithromycin|Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
16357398|NCT00201409|Drug|Placebo|Placebo will be administered by slow intravenous infusion once daily for 14 days.
16357399|NCT00201409|Drug|GM-CSF|Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.
16357400|NCT00201396|Radiation|CCRT|Radiation with weekly Cisplatin
16357401|NCT00201396|Drug|Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin|Induction C/T + CCRT
16357402|NCT00201383|Drug|cisplatin|
16357403|NCT00201357|Drug|Thalidomide (THADO)|patients who receive thalidomide (100 mg BID).
16357404|NCT00201344|Drug|Cisplatin,5-FU,Leucovorin|
16357405|NCT00201331|Drug|leucovorin+5-FU|
16357406|NCT00201318|Drug|Cyclophosphamide Doxorubicin Vincristine Lamivudine|
16357407|NCT00201305|Drug|Gemcitabine+5FU+Leucovorin|
16357408|NCT00201279|Drug|13-cis Retino Acid|
16357409|NCT00201266|Procedure|Screening|Characterization tests including blood group typing, measures of lung function, measures of allergy, and collection of DNA.
16357410|NCT00201253|Other|Bronchoalveolar lavages and venipunctures only|
16357411|NCT00201240|Biological|CD34+ selection with CliniMACS device|CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs) in place and validated at the study sites. CliniMACS (Miltenyi device) to target CD34+ >5 x 10*6/kg and CD3+ < 1 x 10*5/kg
16357412|NCT00201227|Other|practice guideline adherence|Project facilitator assist primary care practice clinicians and staff work in effective quality improvement teams through the use of facilitated collaborative meetings.
16357413|NCT00201214|Drug|Citrulline|Phase I - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with dosage escalation study 50mg/kg, 100mg/kg, 150mg/kg IV at 6, 12, 24, 48 hours post operative. Phase II - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with 9mg/kg/hr continuous IV starting 4 hours post bolus and infusing for 48 hours or discharge from PCCU.
16357414|NCT00201201|Other|Education Intervention|Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program.
16357415|NCT00201201|Other|Control|Control group receiving care as usual after interfacing with the surveys on the PEP-NG
16357416|NCT00201188|Behavioral|Status Reports|Interpreted Analysis of Peak-Flow Monitoring Trends
16357417|NCT00201162|Dietary Supplement|Soy|Dietary supplement of isolated soy protein containing isoflavones
16357418|NCT00201162|Dietary Supplement|Placebo|dietary supplement casein placebo
16357419|NCT00201149|Behavioral|Patient-centered Counseling|To improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and doctor-patient communication, we propose a three-armed randomized controlled trial in the internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement an intervention strategy by teaching clinicians to counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support; critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors, and which will enhance doctor-patient communication.
16357420|NCT00201136|Behavioral|Lifestyle interventions to lower blood pressure for patients|Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
16357421|NCT00201136|Behavioral|MD CQI-type intervention|CQI-type intervention for MD adherence to JNC guidelines for BP management
16357422|NCT00201123|Drug|Aerosol Interferon-Gamma|Participants will receive aerosol interferon-gamma.
16357423|NCT00201123|Drug|Subcutaneous interferon-gamma|Patients will receive subcutaneous interferon-gamma
16357424|NCT00201123|Other|Placebo|
16357425|NCT00201110|Behavioral|Problem Solving Skills|Intensive Intervention: CVD Risk Self-Management Education (1 session) + Intensive Health Problem-Solving Training (8 sessions)
16357426|NCT00201110|Behavioral|Problem Solving Skills|Brief Intervention: CVD Risk Self-Management Education (1 session) + Brief Problem-Solving Training (1 session)
16357427|NCT00201084|Behavioral|Uncertainty reduction|At physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling
16357428|NCT00201058|Behavioral|Tailored Web-based Asthma Management|Web-based asthma management
16357429|NCT00201058|Behavioral|Generic web-based asthma education|4 computer sessions over a period of 180 days
16357430|NCT00201045|Other|Physician/Pharmacist Collaborative Teams|The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
16357431|NCT00201019|Behavioral|Physician-pharmacist collaborative intervention|Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.
16357432|NCT00201006|Behavioral|Face-to-face counseling|Biweekly group behavioral counseling sessions conducted in a face-to-face format
16357433|NCT00201006|Behavioral|Telephone counseling|Biweekly telephone counseling sessions conducted in a one-on-one format
16357494|NCT00200369|Device|MEMS cap|
16365613|NCT00129142|Drug|Toremifene Citrate|
16357436|NCT00200967|Drug|salmeterol|50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)
16357437|NCT00200967|Drug|beclomethasone HFA|240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)
16357438|NCT00200954|Dietary Supplement|Probiotic bacteria|3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.
16357439|NCT00200954|Dietary Supplement|Placebo|The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
16357440|NCT00200941|Drug|Topiramate|
16357441|NCT00200928|Biological|BCG|
16357442|NCT00200902|Drug|Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)|Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
16357443|NCT00200902|Other|Placebo|Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
16357444|NCT00200902|Behavioral|Interpersonal Clinical Interaction (ICI)|Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
16357445|NCT00200889|Device|active auricular tVNS|non-painful active auricular tVNS will be delivered to the left ear
16357446|NCT00200889|Device|inactive auricular tVNS|non-painful inactive auricular tVNS will be delivered to the left ear
16357447|NCT00200876|Procedure|Hypertonic saline|To elicit pain
16357448|NCT00200876|Procedure|Isotonic saline|Non-painful control
16357449|NCT00200863|Device|Monochromatic visible light exposure|Monochromatic light in the visible range from 420-620 nm up to 60uW/cm2 for 6.5 hours
16357450|NCT00200850|Biological|House Dust Mite SLIT|low dose SLIT 143 Allergen Units(AU)/ml daily
16357451|NCT00200850|Biological|High dose SLIT|House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily
16357452|NCT00200850|Biological|Placebo SLIT|Placebo SLIT daily
16357453|NCT00200824|Drug|Soy Isoflavone Nutritional Supplements|
16357454|NCT00200785|Dietary Supplement|garlic powder added to ambient water|consumed 2.7 grams of garlic powder added to ambient water (equivalent to 8 grams fresh or raw garlic) in a sandwich, once a day for four weeks
16357455|NCT00200785|Dietary Supplement|garlic powder added to boiling water|consumed 2.7 grams of garlic powder added to boiling water (equivalent to 8 grams of cooked garlic) in a sandwich, once a day for four weeks
16357456|NCT00200759|Drug|Cranberry juice and capsules|
16357457|NCT00200746|Drug|Arginine|Amino Acid Arginine
16357458|NCT00200720|Behavioral|Atkins diet (low carbohydrate diet)|
16357459|NCT00200720|Behavioral|DASH diet (high carbohydrate diet)|
16357460|NCT00200707|Procedure|Intracoronary injection of autologous bone marrow mononuclear cells|
16357461|NCT00200694|Drug|ramipril 5 mg + valsartan 80 mg/day,|
16357462|NCT00200694|Drug|ramipril 10 mg + valsartan 160 mg/day,|
16357463|NCT00200694|Drug|ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.|
16357464|NCT00200681|Drug|Velcade|
16357465|NCT00200668|Drug|FDG = fluorodeoxyglucose|
16357466|NCT00200655|Drug|Pravastatin|
16357467|NCT00200655|Drug|Placebo|
16357468|NCT00200642|Device|Stretta® System|
16357469|NCT00200629|Procedure|Adenosine SPECT myocardial perfusion imaging|
16357470|NCT00200629|Procedure|Combined adenosine / exercise SPECT myocardial perfusion imaging|
16357471|NCT00200616|Procedure|Antimicrobial prophylaxis|
16357472|NCT00200603|Device|calcium phosphate macroporous bioceramics|
16357473|NCT00200590|Drug|acetaminophen and nalbuphine|
16357474|NCT00200590|Drug|acetaminophen and morphine|
16357475|NCT00200590|Drug|acetaminophen and reduced dosage of prostaglandin|
16357476|NCT00200577|Drug|TIL + IL2|Patients are treated with 2 injections Of TIL (1st injection M1 and the second M2)The received concomitant IL2 at M1 and M2 on days Jo (injection TIL) to J5 and J8 to J12
16357477|NCT00200564|Drug|ketamine|
16357478|NCT00200551|Drug|Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.|
16357479|NCT00200551|Drug|Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.|
16357480|NCT00200538|Drug|memantine|
16357481|NCT00200525|Drug|apomorphine HCl injection|
16357482|NCT00200512|Drug|apomorphine HCl injection|
16357483|NCT00200499|Drug|Nebivolol|
16357484|NCT00200473|Drug|Nebivolol|
16357485|NCT00200460|Drug|Nebivolol|
16357486|NCT00200447|Drug|carbidopa/l-dopa|
16357487|NCT00200447|Drug|carbidopa/l-dopa/entacapone|
16357488|NCT00200447|Drug|Stalevo|
16357489|NCT00200447|Procedure|[123I]-IBZM imaging|
16357490|NCT00200434|Drug|Nebivolol|
16357491|NCT00200421|Drug|Nebivolol and Atenolol|
16357492|NCT00200395|Drug|Tarceva|OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.
16357493|NCT00200382|Drug|PS-341 (Velcade-drug)|
16357495|NCT00200356|Drug|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
16357496|NCT00200356|Drug|Sodium Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
16357497|NCT00200343|Drug|Ursodeoxycholic acid 150mg / day|Ursodeoxycholic acid, 150mg/ day, three times a day at meals
16357498|NCT00200343|Drug|Ursodeoxycholic acid 600mg / day|Ursodeoxycholic acid, 600mg/ day, three times a day at meals
16357499|NCT00200343|Drug|Ursodeoxycholic acid 900mg / day|Ursodeoxycholic acid, 900mg/ day, three times a day at meals
16357500|NCT00200330|Behavioral|Behavioral weight loss treatment|
16357501|NCT00200330|Behavioral|Behavioral and home environment weight loss treatment|
16357502|NCT00200317|Behavioral|Internet and print-based interventions|
16357503|NCT00200304|Behavioral|Internet weight loss with SlimFast and human counseling|
16357504|NCT00200304|Behavioral|Internet weight loss with SlimFast and computer counseling|
16357505|NCT00200304|Behavioral|Internet weight loss program with SlimFast|
16357506|NCT00200291|Behavioral|hypocaloric, low-fat diet|hypocaloric, low-fat diet
16357507|NCT00200278|Behavioral|PROJECT STRIDE|
16357508|NCT00200265|Behavioral|diet|diet
16357509|NCT00200252|Drug|oxytocin|
16357510|NCT00200239|Behavioral|Eating breakfast with portion and unportioned foods|Behavioral: eating breakfast with portion and unportioned foods
16357511|NCT00200226|Drug|misoprostol|misoprostol 400mcg 12 hrs prior to procedure
16357512|NCT00200226|Drug|vitamin B6|Vitamin B6 50 mg orally 12 hrs prior to procedure
16357513|NCT00200213|Behavioral|portion or unportioned food|
16357514|NCT00200200|Drug|Bevacizumab HAI plus systemic chemotherapy|Oxaliplatin (mg/m2) IV, over 2 hours, 5 FU (mg/m2) continuous infusion, over two days, leucovorin (mg/m2) IV, over 2 hours
16357515|NCT00200200|Drug|HAI plus systemic chemotherapy|Irinotecan (mg/m2) IV, over 30 minutes, 5 FU (mg/m2) continuous infusion over two days, leucovorin (mg/m2) IV, over 30 minutes
16357516|NCT00200187|Procedure|low venous pressure general anesthesia|
16357517|NCT00200187|Procedure|combined spinal-epidural anesthesia|
16357518|NCT00200174|Drug|Raloxifene followed by combination therapy|Patients will be randomized to either Raloxifene at 60mg P.O. (each day) for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
16357519|NCT00200174|Drug|Exemestane followed by combination therapy|Patients will be randomized to Exemestane at 25mg P.O. for 2 weeks (time designated: week- 2) After two weeks of single agent therapy, patients will be started on combination therapy with oral raloxifene (60mg/day) and oral exemestane (25mg/day) (time designated week 0), and continued on both drugs for one year (month 12). Patients will be required to start supplemental calcium (900-1500 mg/day) plus vitamin D (400-600 units/day) P.O. each day during week 0.
16357520|NCT00200161|Drug|Temozolomide|Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
16357521|NCT00200161|Drug|Temozolomide|Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
16357522|NCT00200148|Procedure|Normovolemic Hemodilution (ANH)|For those patients randomized to ANH, the pre-calculated volume of blood will be withdrawn to a target hemoglobin of 8.0 - 8.5 g/dl (maximum of 3 L) using the formula VL=EBV x (HO-HF)/Hav, as above. The removed blood will be stored in a standard citrate-phosphate-dextrose buffer solution in blood storage bags in the operating room. During removal of blood, colloid and crystalloid solutions will be administered via peripheral intravenous lines in order to maintain euvolemia. For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.For patients randomized to ANH, autologous blood will be re-infused in the reverse order from which it was removed, and allogeneic blood will given only after all autologous blood has been given.
16357523|NCT00200148|Procedure|Standard of care|An 8.5 French central venous catheter and an arterial line will be placed in all patients. If the patient has a central line already in place, this may be used in place of the 8.5 French internal jugular catheter. Continuous monitoring of heart rate, blood pressure, ECG (II, V5), CVP, end tidal CO2, oxygen saturation, temperature and urine output will be performed for all patients.For all hepatic resections, standard low CVP anesthetic management will be employed.For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.All patients will receive standard postoperative management. Routine laboratory studies, including comprehensive panel, CBC and coagulation profile, will be obtained daily in the post-operative period.
16357524|NCT00200122|Device|Spinal Cord Stimulation|
16357525|NCT00200109|Device|Occipital Nerve Stimulation|Each group had a different plan
16357526|NCT00200096|Procedure|Acupuncture and questionnaires|"Acupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why.
~On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated posttreatment values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation."
16357575|NCT00199511|Drug|Administration of Hypertonic Solution 7.5% vs Mannitol 20%|
16366818|NCT00119847|Procedure|PCI|
16357527|NCT00200096|Procedure|placebo acupuncture|"During the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries.
~Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure."
16357528|NCT00200083|Device|Transcend II Model 8848|"All subjects will be implanted with the IGS device and then randomized to on or off for 12 months. After 12 months all subjects will be turned on through 24 month follow up."
16357529|NCT00200070|Device|Spinal Cord Stimulation|
16357530|NCT00200057|Device|InterStim Sacral Nerve Stimulation Therapy|Open label study. All subjects that qualify for the study will be implanted.
16357531|NCT00200044|Device|Gatekeeper Reflux Repair System|The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.
16357532|NCT00200031|Device|Interstim therapy|
16357533|NCT00200018|Device|Enterra Therapy System (H9900014)|
16357534|NCT00200005|Device|Type: Implantable neurostimulator; InterStim|Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
16357535|NCT00199992|Procedure|application of autologous platelet gel|
16357536|NCT00199979|Drug|Nevirapine|
16357537|NCT00199966|Drug|Divalproex sodium extended release|
16357538|NCT00199953|Drug|Rabeprazole 20 mg twice a day for 90-day period treatment|
16357539|NCT00199940|Drug|Ziprasidone|
16357540|NCT00199927|Drug|Fluvastatin|Starting dose of Fluvastatin of 40 mg/day uptitrated to 80 mg/day
16357541|NCT00199927|Drug|standard therapy|standard therapy
16357542|NCT00199914|Device|Shortwave diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
16357543|NCT00199901|Biological|NY-ESO-1 ISCOMATRIX®|"100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.
~Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days)."
16357544|NCT00199901|Biological|ISCOMATRIX® adjuvant|"120 μg of ISCOMATRIX® adjuvant
~Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days)."
16357545|NCT00199888|Drug|124-Iodine-cG250 (124I-cG250)|
16357546|NCT00199875|Drug|Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)|Patients received a single infusion of ^90Y-DOTA-cG250, with escalating doses administered to sequentially enrolled cohorts until MTD determination.
16357547|NCT00199862|Drug|Iodine-124 labeled humanized A33 (antibody)|Patients will receive a single intravenous or intraarterial infusion of 10mg huA33, labeled with 4mCi-10mCi of 124I in 5-30ml of 5% HSA in normal saline (NS), over 5-10 minutes. On study days 2, 3, and/or 4 patients will have the option to receive up to 2g/kg of IVIG. Patients will be evaluated with 124I-huA33 positron-emission tomography (PET) with ex vivo quantitation of tumor uptake.
16357548|NCT00199849|Biological|NY-ESO-1 Plasmid DNA Cancer Vaccine|NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.
16357549|NCT00199836|Biological|NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51|
16357550|NCT00199823|Genetic|Intracoronary aotologous stem cell transplantation|
16357551|NCT00199797|Drug|Oxaliplatin|Oxaliplatin was administered at 85 mg/m2 on day 2 of every 2 week regimen.
16357552|NCT00199797|Drug|5-Fluorouracil|The dose of 5-FU was 400 mg/m2 IV bolus followed by continuous IV infusion at 600 mg/m2 over 22 hours on day 2 and day 3 of every 2 week regimen.
16357553|NCT00199797|Drug|Leucovorin|Leucovorin was administered at a dose of 200mg/m2 on day 2 and day 3 of every 2 week regimen.
16357554|NCT00199797|Drug|huA33|huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2.
16357555|NCT00199784|Drug|Phenylephrine|
16357556|NCT00199771|Drug|7.5% NaCl in 6% dextran 70 solution|
16357557|NCT00199758|Drug|cisplatin|
16357558|NCT00199758|Drug|Gemcitabine|
16357559|NCT00199758|Drug|Taxol|
16357560|NCT00199745|Drug|atorvastatin|
16357561|NCT00199719|Drug|Ribavirine|
16357562|NCT00199706|Drug|7.2% NaCl in 6% hydroxyethyl starch solution|
16357563|NCT00199680|Procedure|PET|
16357564|NCT00199667|Drug|Mycophenolate Mofetil|
16357565|NCT00199654|Procedure|PET|
16357566|NCT00199641|Device|enteral nutrition|
16357567|NCT00199615|Procedure|PET|Intravenous injection of glucose labeled Fluor 18.Le patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during which the patient should not move.
16357568|NCT00199602|Drug|warfarine - low molecular heparin|
16357569|NCT00199589|Drug|Botulinic toxin (Botox)|Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.
16357570|NCT00199576|Drug|Methylprednisolone|
16357571|NCT00199563|Drug|Viagra|Sildenafil 100mg daily for 12 weeks
16357572|NCT00199550|Procedure|Bipolar Transurethral Resection of the Prostate|Bipolar TURP
16357573|NCT00199550|Procedure|Monopolar Transurethral Resection of the Prostate|Monopolar TURP
16357574|NCT00199524|Device|Navigator Ureteral Access Sheath|ureteral access sheath
16357685|NCT00199017|Drug|Cyclophosphamide|
16357576|NCT00199498|Device|Apical RV lead placement|RV lead implanted ( according to randomization )at the apex
16357577|NCT00199498|Device|Septal RV lead placement|RV lead is implanted (according to randomization), on septum
16357578|NCT00199485|Drug|Angelica Sinensis|Angelica Sinensis / placebo
16357579|NCT00199472|Procedure|Dynamic Contrast Enhanced CT & Diuretic Renogram|
16357580|NCT00199446|Drug|Istradefylline (KW-6002)|
16357581|NCT00199433|Drug|Istradefylline (KW-6002)|
16357582|NCT00199420|Drug|Istradefylline (KW-6002)|
16357583|NCT00199407|Drug|Istradefylline (KW-6002)|
16357584|NCT00199394|Drug|Istradefylline (KW-6002)|
16357585|NCT00199381|Drug|Istradefylline|Oral istradefylline (KW-6002) 20 or 40 mg once daily.
16357586|NCT00199368|Drug|Istradefylline ( KW-6002)|
16357587|NCT00199355|Drug|Istradefylline (KW-6002)|
16357588|NCT00199342|Drug|KW-2871|potentially therapeutic monoclonal antibody for the treatment of advanced stage four melanoma
16357589|NCT00199329|Drug|ondansetron adding in PCA|
16357590|NCT00199316|Drug|spinal morphine|
16357591|NCT00199303|Drug|pre-operatively followed by 30 mg three times per day after surgery|
16357592|NCT00199290|Drug|Trafermin (genetical recombination)|
16357593|NCT00199277|Drug|i.v. iron sucrose|
16357594|NCT00199277|Drug|Oral iron|
16357595|NCT00199264|Drug|Albaconazole oral solution|
16357596|NCT00199251|Drug|RUPATADINE|
16357597|NCT00199238|Drug|RUPATADINE (ANTI-HISTAMINE)|
16357598|NCT00199225|Drug|Rupatadine|
16357599|NCT00199225|Drug|moxifloxacin|
16357600|NCT00199225|Procedure|Continous electrocardiographic register|
16357601|NCT00199225|Procedure|Pharmacokinetic profile|
16357602|NCT00199212|Drug|Combination of trastuzumab and PS-341|Trastuzumab and velcade are used according standard procedure
16357603|NCT00199186|Drug|imatinib|
16357604|NCT00199186|Drug|vincristine|
16357605|NCT00199186|Drug|cyclophosphamide|
16357606|NCT00199186|Drug|cytosine arabinoside|
16357607|NCT00199186|Drug|dexamethasone|
16357608|NCT00199186|Drug|idarubicin|
16357609|NCT00199186|Drug|methotrexate (intrathecal)|
16357610|NCT00199186|Drug|AraC (intrathecal)|
16357611|NCT00199186|Drug|dexamethasone (intrathecal)|
16357612|NCT00199173|Device|SIR Spheres intra-arterial hepatic|
16357613|NCT00199160|Drug|BAY 43-9006|
16357614|NCT00199147|Drug|Cytarabine|
16357615|NCT00199147|Drug|Etoposide|
16357616|NCT00199147|Drug|Idarubicin|
16357617|NCT00199147|Drug|G-CSF|
16357618|NCT00199147|Drug|Fludarabine|
16357619|NCT00199147|Procedure|Stem cell apheresis|
16357620|NCT00199147|Procedure|Stem cell transplantation|
16357621|NCT00199134|Drug|Letrozole|Size of the tumor is followed
16357622|NCT00199121|Drug|Zidovudine (drug)|
16357623|NCT00199108|Drug|Depocyt|
16357624|NCT00199108|Drug|Dexamethasone|
16357625|NCT00199095|Drug|Adriamycin|
16357626|NCT00199095|Drug|Cyclophosphamide|
16357627|NCT00199095|Drug|Cytarabine|
16357628|NCT00199095|Drug|Dexamethasone|
16357629|NCT00199095|Drug|Idarubicin|
16357630|NCT00199095|Drug|Ifosfamide|
16357631|NCT00199095|Drug|Methotrexate|
16357632|NCT00199095|Drug|Mercaptopurine|
16357633|NCT00199095|Drug|VM26|
16357634|NCT00199095|Drug|Vincristine|
16357635|NCT00199082|Drug|Adriamycin|
16357636|NCT00199082|Drug|Cyclophosphamide|
16357637|NCT00199082|Drug|Cytarabine|
16357638|NCT00199082|Drug|Dexamethasone/Prednisolone|
16357639|NCT00199082|Drug|VP16|
16357640|NCT00199082|Drug|Ifosfamide|
16357641|NCT00199082|Drug|Methotrexate|
16357642|NCT00199082|Drug|G-CSF|
16357643|NCT00199082|Drug|Rituximab|
16357644|NCT00199082|Drug|Vincristine/Vindesine|
16357645|NCT00199082|Procedure|Irradiation (in specific conditions)|
16357646|NCT00199069|Drug|Asparaginase|
16357647|NCT00199069|Drug|Vincristine|
16357648|NCT00199069|Drug|Daunorubicin, Adriamycin|
16357649|NCT00199069|Drug|Cyclophosphamide|
16357650|NCT00199069|Drug|Ifosfamide|
16357651|NCT00199069|Drug|Cytarabine|
16357652|NCT00199069|Drug|Mitoxantrone|
16357653|NCT00199069|Drug|Methotrexate|
16357654|NCT00199069|Drug|6-Mercaptopurine|
16357655|NCT00199069|Drug|6-Thioguanine|
16357656|NCT00199069|Drug|VM26|
16357657|NCT00199069|Drug|Dexamethasone / Prednisolone|
16357658|NCT00199069|Procedure|CNS Irradiation|
16357659|NCT00199069|Procedure|Mediastinal Irradiation|
16357660|NCT00199069|Procedure|Stem Cell Transplantation|
16357661|NCT00199056|Drug|Dexamethasone / Prednisolone|
16357662|NCT00199056|Drug|Cyclophosphamide|
16357663|NCT00199056|Drug|Methotrexate|
16357664|NCT00199056|Drug|Vincristine / Vindesine|
16357665|NCT00199056|Drug|Daunorubicin|
16357666|NCT00199056|Drug|Asparaginase|
16357667|NCT00199056|Drug|G-CSF|
16357668|NCT00199056|Drug|Cytarabine|
16357669|NCT00199056|Drug|6-Mercaptopurine|
16357670|NCT00199056|Drug|VP16|
16357671|NCT00199056|Drug|Adriamycin|
16357672|NCT00199056|Drug|Thioguanine|
16357673|NCT00199056|Drug|VM26|
16357674|NCT00199056|Drug|Idarubicin|
16357675|NCT00199056|Drug|Fludarabine|
16357676|NCT00199056|Drug|Ifosfamide|
16357677|NCT00199056|Procedure|CNS irradiation|
16357678|NCT00199056|Procedure|Mediastinal irradiation (if residual tumor)|
16357679|NCT00199056|Procedure|stem cell transplantation|
16357680|NCT00199043|Drug|Allopurinol|
16357681|NCT00199043|Drug|Rasburicase|
16357682|NCT00199030|Drug|Alemtuzumab (MabCampath)|
16357683|NCT00199030|Drug|Cladribine|
16357684|NCT00199017|Drug|Dexamethasone/Prednisolone|
16357699|NCT00199017|Procedure|Mediastinal irradiation|
16357700|NCT00199017|Drug|Cladribine|
16357701|NCT00199004|Drug|Cyclophosphamide|
16357702|NCT00199004|Drug|Dexamethasone / Prednisolone|
16357703|NCT00199004|Drug|Vincristine|
16357704|NCT00199004|Drug|Daunorubicin|
16357705|NCT00199004|Drug|Asparaginase|
16357706|NCT00199004|Drug|Methotrexate|
16357707|NCT00199004|Drug|Cytarabine|
16357708|NCT00199004|Drug|Mercaptopurine|
16357709|NCT00199004|Drug|G-CSF|
16357710|NCT00199004|Drug|Vindesine|
16357711|NCT00199004|Drug|VP16|
16357712|NCT00199004|Drug|Adriamycin|
16357713|NCT00199004|Drug|Thioguanine|
16357714|NCT00199004|Drug|VM26|
16357715|NCT00199004|Drug|Rituximab|
16357716|NCT00199004|Procedure|CNS irradiation|
16357717|NCT00199004|Procedure|Mediastinal irradiation (if residual TU)|
16357718|NCT00199004|Procedure|Stem cell transplantation|
16357719|NCT00198991|Drug|Cyclophosphamide|
16357720|NCT00198991|Drug|Dexamethasone|
16357721|NCT00198991|Drug|Vincristine|
16357722|NCT00198991|Drug|daunorubicin|
16357723|NCT00198991|Drug|Asparaginase|
16357724|NCT00198991|Drug|Methotrexate|
16357725|NCT00198991|Drug|Cytarabine|
16357726|NCT00198991|Drug|Mercaptopurine|
16357727|NCT00198991|Drug|G-CSF|
16357728|NCT00198991|Drug|Vindesine|
16357729|NCT00198991|Drug|VP16|
16357730|NCT00198991|Drug|Prednisolone|
16357731|NCT00198991|Drug|Adriamycin|
16357732|NCT00198991|Drug|Thioguanine|
16357733|NCT00198991|Drug|VM26|
16357734|NCT00198991|Procedure|CNS irradiation|
16357735|NCT00198991|Procedure|Mediastinal Irradiation|
16357736|NCT00198991|Procedure|Stem cell transplantation|
16357737|NCT00198991|Drug|Idarubicin|
16357738|NCT00198991|Drug|Fludarabine|
16357739|NCT00198991|Drug|Cladribine|
16357740|NCT00198978|Drug|Cyclophosphamide|
16357741|NCT00198978|Drug|Dexamethasone / Prednisolone|
16357742|NCT00198978|Drug|Cytarabine|
16357743|NCT00198978|Drug|Idarubicin|
16357744|NCT00198978|Drug|Granulocyte-Colony-Stimulating Factor|
16357745|NCT00198978|Drug|Mercaptopurine|
16357746|NCT00198978|Drug|Methotrexate|
16357747|NCT00198978|Drug|Rituximab|
16357748|NCT00198978|Drug|HDARAC|
16357749|NCT00198978|Drug|Vincristine|
16357750|NCT00198978|Drug|Depocyte|
16357751|NCT00198978|Drug|Asparaginase|
16357752|NCT00198965|Behavioral|dietary education|
16357753|NCT00198965|Behavioral|dietary education and provided full fat snack foods|
16357754|NCT00198965|Behavioral|dietary education and provided fat free snack foods|
16357755|NCT00198952|Drug|DietPro|
16357756|NCT00198952|Drug|Placebo|
16357757|NCT00198939|Behavioral|Integrated Family and Cognitive-Behavioral Drug Prevention Intervention|The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
16357758|NCT00198939|Other|Psychoeducation|Drug education curriculum was delivered to participants assigned to this condition.
16357759|NCT00198926|Behavioral|covert v overt nutrition labeling|
16357760|NCT00198926|Behavioral|varying meal nutrition manipulation|
16357761|NCT00198913|Behavioral|lower fat food supplied and education|
16357762|NCT00198913|Behavioral|gift cards for grocery foods and written education|
16357763|NCT00198900|Behavioral|survey of information|
16357764|NCT00198887|Procedure|Operations research|
16357765|NCT00198874|Behavioral|Integrated Family and Cognitive-Behavioral Therapy|The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
16357766|NCT00198874|Other|Education|Drug education curriculum was delivered to participants assigned to this condition.
16357767|NCT00198861|Other|Injection and Non-Injection Drug Users|(1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors.
16357768|NCT00198848|Drug|Iron-folic acid supplement|
16357769|NCT00198835|Behavioral|Maternal nutrition and infant feeding advice|
16357770|NCT00198822|Dietary Supplement|Vitamin A or Beta-Carotene Supplements|weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
16357771|NCT00198809|Drug|Biolean + Diet education|
16357772|NCT00198809|Drug|Biolean Free + Diet education|
16357773|NCT00198809|Drug|Placebo + Diet education|
16357774|NCT00198796|Biological|H10407|The primary objective of the proposed clinical investigation is to validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea
16357775|NCT00198770|Dietary Supplement|dietary substitution to assess level of caloric compensation|Mushrooms substituted for meat in dishes
16357776|NCT00198757|Behavioral|Medifast Plus for Diabetics Meal Replacement Supplements|
16357777|NCT00198757|Behavioral|Standard ADA recommended diet for type 2 diabetics|
16357778|NCT00198744|Behavioral|Medifast FIT! for Kids|
16357779|NCT00198744|Behavioral|standard recommendations for dietary intake in children|
16357780|NCT00198744|Behavioral|both diet plans with and without a parent dieting|
16358046|NCT00196339|Drug|Cyproterone acetate 15|Cyproterone acetate 15 mg
16357781|NCT00198731|Behavioral|Care Seeking for Obstetric Complication|This is a descriptive study of knowledge, practices and outcomes related to maternal morbidity during pregnancy, childbirth and postpartum.
16357782|NCT00198718|Drug|Vitamin A (retinyl palmitate)|
16357783|NCT00198705|Behavioral|Improved management of severe neonatal infections|
16357784|NCT00198692|Behavioral|self-management|
16357785|NCT00198679|Drug|Chlorhexidine|
16357786|NCT00198666|Drug|Zinc|Elemental Zinc
16357787|NCT00198653|Behavioral|Newborn Thermal Care Practice|
16357788|NCT00198640|Procedure|Antibiotic use|
16357789|NCT00198627|Drug|Co-Trimoxazole; TMP-SMZ|
16357790|NCT00198614|Drug|Carvedilol versus Metoprolol|
16357791|NCT00198601|Drug|Gentamicin in Uniject Pre-filled syringe|
16357792|NCT00198588|Drug|argatroban|beginning dose: 0.7microgram/kg/H
16357793|NCT00198562|Drug|Amlodipine, Losartan|amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
16357794|NCT00198549|Drug|Vitrase (ovine hyaluronidase) Lyophilized|
16357795|NCT00198536|Drug|Ecabet 2.83%|
16357796|NCT00198536|Drug|Ecabet 3.70%|
16357797|NCT00198536|Drug|Vehicle|
16357798|NCT00198523|Drug|Prednisolone and Tobramycin|
16357799|NCT00198523|Drug|Prednisolone|
16357800|NCT00198510|Drug|Vitrase|7.5 IU of Vitrase
16357801|NCT00198510|Drug|Vitrase|55 IU of Vitrase
16357802|NCT00198510|Drug|Vitrase|75 IU of Vitrase
16357803|NCT00198497|Drug|Placebo|
16357804|NCT00198497|Drug|Vitrase|Hyaluronidase 55 IU in saline solution
16357805|NCT00198497|Drug|Vitrase|Hyaluronidase 75 IU in saline solution
16357806|NCT00198484|Drug|Vitrase|
16357807|NCT00198471|Drug|Vitrase|
16357808|NCT00198458|Drug|Vitrase|
16357809|NCT00198445|Drug|Bromfenac|One drop in study eye every 12 hours for 14 days
16357810|NCT00198445|Drug|Placebo|One drop in study eye every 12 hours for 14 days
16357811|NCT00198432|Drug|Paclitaxel, vinorelbine, cisplatin|
16357812|NCT00198419|Drug|Vitrase|
16357813|NCT00198406|Procedure|diagnostic and therapeutic management|
16357814|NCT00198393|Drug|Gefitinib|250 mg/day, until progression
16357815|NCT00198393|Drug|gemcitabine|1250 mg/m² D1 and D8 (D1=D28, until progression)
16357816|NCT00198393|Drug|Docetaxel|75 mg/m² D1 (D1=D22, until progression)
16357817|NCT00198380|Drug|Gefitinib|Gefitinib 250 mg/day, until progression or severe toxicity
16357818|NCT00198367|Drug|Cisplatin-Gemzar|
16357819|NCT00198367|Drug|Cisplatin-Navelbine-Radiotherapy|
16357820|NCT00198367|Drug|Carboplatin-Taxol-Radiotherapy|
16357821|NCT00198354|Drug|gemcitabine + cisplatine|gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
16357822|NCT00198354|Drug|Paclitaxel + Carboplatine|paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
16357823|NCT00198341|Procedure|Radiological Arm|Clinical Visit + X-Ray Chest
16357824|NCT00198341|Procedure|Scannographic arm|Clinical visit + X-Ray Chest + CT-Scan + Fibroscopy (for squamous cell)
16357825|NCT00198328|Combination Product|Medpulser Electroporation with Bleomycin|Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.
16357826|NCT00198328|Procedure|Surgical Excision|Patients have their tumor surgically removed.
16357827|NCT00198315|Combination Product|Medpulser electroporation with Bleomycin|Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
16357828|NCT00198315|Procedure|Tumor surgical excision|Patients have their tumor surgically removed.
16357829|NCT00198302|Drug|Aurexis®|
16357830|NCT00198289|Drug|Aurexis® (tefibazumab)|
16357831|NCT00198276|Combination Product|MedPulser Electroporation with bleomycin|The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.
16357832|NCT00198263|Combination Product|Medpulser Electroporation with Bleomycin|The MedPulser device will be used in conjunction with injection of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
16357833|NCT00198250|Drug|venlafaxine|Venlafaxine taper dose from 37.5mg for one week to 75 mg for 3 weeks
16357834|NCT00198237|Drug|docetaxel & capecitabine|
16357835|NCT00198224|Procedure|phlebotomy|
16357836|NCT00198198|Drug|Aripiprazole|
16357837|NCT00198185|Procedure|Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery|
16357838|NCT00198172|Drug|Cisplatin plus Epirubicin|
16357839|NCT00198159|Drug|ZD1839 Iressa|
16357840|NCT00198146|Drug|Zenapax|
16357841|NCT00198133|Drug|Premetrexed (Alimta)|Pemetrexed will be 500 mg/m2 IV every 3 weeks
16357842|NCT00198120|Drug|D-cycloserine|D-Cycloserine 0.6mg/kg/day in week 1 D-Cycloserine 1.1mg/kg/day in week 2 D-Cycloserine 1.7mg/kg/day in week 3-8 Flexible dosing based on response. Capsule Strength: 10mg, 20mg
16357843|NCT00198120|Drug|Placebo|Placebo: same dosing schedule and capsule strength
16357844|NCT00198107|Drug|Aripiprazole|Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
16357845|NCT00198107|Drug|Placebo|Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
16357846|NCT00198107|Drug|D-cycloserine|D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
16357847|NCT00198094|Drug|Sertraline and Alprazolam XR|
16357848|NCT00198081|Drug|COX-2 Inhibitor 6-8 weeks prior to surgery|400 mg BID 6-8 weeks prior to surgery
16357849|NCT00198081|Drug|COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP|400 mg BID for 6 months prior to follow-up EUS or ERCP
16357850|NCT00198055|Drug|aripiprazole|Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
16367287|NCT00117013|Drug|Topotecan|
16357851|NCT00198042|Procedure|Surgical reconstruction of the ACL|Surgical reconstruction of the ACL
16357852|NCT00198029|Device|Synvisc (hylan G-F20)|32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection
16357853|NCT00198016|Device|Coil|
16357854|NCT00198003|Behavioral|Educational program to address patients' expectations|
16357855|NCT00197977|Behavioral|Educational program to address patients' expectations|
16357856|NCT00197964|Behavioral|Enhance asthma knowledge, self-efficacy, social support|
16357857|NCT00197951|Drug|Treatment of psychiatric symptoms associated to alcoholism|
16357858|NCT00197938|Procedure|Measurement of rectal lactic acid.|
16357859|NCT00197925|Biological|Onco-peptide loaded autologous dendritic cells|
16357860|NCT00197912|Biological|tumor antigen loaded autologous dendritic cells|DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with p53, survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate pulsed dendritic cells. 50 mg cyclophosphamide (Sendoxan®, Baxter A/S) is administered p.o. twice a day bi-weekly and 200 mg celecoxib (Celebra®, Pfizer) is given p.o. every day. From the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
16357861|NCT00197899|Drug|E. Coli endotoxin|
16357862|NCT00197886|Drug|Changing dose of norepinephrine and blood pressure|
16357863|NCT00197873|Dietary Supplement|Lactobacillus Rhamnosus supplementation|Lactophilus supplementation is administered during chemotherapy.
16357864|NCT00197873|Other|Placebo administration.|Placebo is administered during chemotherapy.
16357865|NCT00197860|Biological|tumor antigen loaded autologous dendritic cells|DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells i.d. 1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week and from the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
16357866|NCT00197834|Drug|Depakote|
16357867|NCT00197821|Biological|pneumococcal conjugate vaccine|Pneumococcal conjugate vaccine
16357868|NCT00197808|Biological|menjugate|men C conjugate vaccine
16357869|NCT00197808|Biological|Men C conjugate vaccine|men C conjugate vaccine
16357870|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
16357871|NCT00197808|Biological|Men C Conjugate|men C conjugate vaccine
16357872|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
16357873|NCT00197808|Biological|Men C conjugate|men C conjugate vaccine
16357874|NCT00197795|Biological|"Meningococcal outer membrane vesicle vaccine MenBVac"|
16357875|NCT00197782|Biological|Hib conjugate vaccine|
16357876|NCT00197769|Biological|9 valent pneumococcal con jugate vaccine|
16357877|NCT00197756|Dietary Supplement|Vitamin A alone|30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
16357878|NCT00197756|Dietary Supplement|Multivitamins excluding vitamin A|30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
16357879|NCT00197756|Dietary Supplement|multivitamins including vitamin A|20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
16357880|NCT00197756|Other|Placebo|Placebo pill taken orally once per day during pregnancy and lactation
16357881|NCT00197743|Dietary Supplement|Vitamin A + Beta Carotene|one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
16357882|NCT00197743|Dietary Supplement|Multivitamins|one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid
16357883|NCT00197743|Other|Placebo|Placebo pill
16357884|NCT00197730|Drug|Multivitamins - vitamins B complex, C and E|Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
16357885|NCT00197730|Drug|Placebo|Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months
16357886|NCT00197704|Dietary Supplement|Multivitamins|5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
16357887|NCT00197704|Other|Placebo|Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
16357888|NCT00197691|Procedure|blood draws, etc.|
16357889|NCT00197678|Dietary Supplement|Multivitamins-Multiples of RDA|20 mg B1, 20 mg B2, 25 mg B6, 50 mcg B12, 100 mg niacin, 500 mg C, 30 mg E, 0.8 mg folic acid taken orally once per day until 6 weeks after delivery
16357890|NCT00197678|Dietary Supplement|Multivitamins-Single RDA|1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 50 mcg B12, 100 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid taken orally once per day until 6 weeks after delivery
16357891|NCT00197639|Drug|Ritonavir-boosted indinavir|
16357892|NCT00197613|Drug|(A) zidovudine, lamivudine and nevirapine|
16357893|NCT00197613|Drug|(B) zidovudine, lamivudine and efavirenz|
16357894|NCT00197613|Drug|(C) zidovudine, didanosine, and nevirapine|
16357895|NCT00197613|Drug|(D) zidovudine, didanosine, and efavirenz|
16357896|NCT00197613|Drug|(E) stavudine, lamivudine, and nevirapine|
16357897|NCT00197613|Drug|(F) stavudine, lamivudine and efavirenz|
16357898|NCT00197613|Procedure|Adherence Strategy Standard of Care (SOC)|
16357899|NCT00197613|Procedure|Adherence Strategy Community-Based DOT|
16357900|NCT00197587|Drug|Nevirapine|All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.
16357901|NCT00197587|Drug|No intervention|All women received a background of zidovudine from 34 weeks'gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.
16357902|NCT00197561|Dietary Supplement|Placebo|Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
16357903|NCT00197561|Dietary Supplement|Selenium|200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
16357904|NCT00197548|Dietary Supplement|Multivitamins-vitamins B-complex, C, and E|One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
16357905|NCT00197548|Dietary Supplement|Placebo|One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
16357906|NCT00197522|Biological|CD34+ derived DCs|
16357907|NCT00197509|Behavioral|Sit-To-Stand Protocol and Extra Practice in Sit-To-Stand|
16357908|NCT00197496|Procedure|Body weight supported treadmill training|hip fracture patients walk on a treadmill with body weight support
16357909|NCT00197483|Drug|Pergolide (drug)|
16357910|NCT00197470|Procedure|IL-1, TNF-alpha, Il-10|
16357911|NCT00197457|Procedure|serum pepsinogen|
16357912|NCT00197457|Procedure|urea breath test|
16357913|NCT00197444|Drug|CDGP/5-FU combined with radiation|Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.
16357914|NCT00197444|Radiation|Radiotherapy|Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.
16357915|NCT00197431|Drug|S-1|
16357916|NCT00197418|Drug|rabeprazole, amoxicillin, clarithromycin, metronidazole|
16357917|NCT00197392|Device|Bactiseal TM EVD|Standard of care implantation of external ventricular drainage catheter
16357918|NCT00197392|Device|Standard EVD Catheter|Standard of care EVD system other than Bactiseal.
16357919|NCT00197379|Drug|roxithromycin|
16357920|NCT00197353|Drug|Epidural bupivacaine (dose/concentration/volume ranging)|
16357921|NCT00197340|Drug|Epidural ropivacaine|
16357922|NCT00197327|Drug|Epidural bupivacaine (0.25% versus 0.0625%)|
16357923|NCT00197314|Behavioral|circular muscle exercises versus pelvic floor exercises|
16357924|NCT00197301|Biological|Vaccination|
16357925|NCT00197288|Biological|Influenza|
16357926|NCT00197275|Biological|Hib-MenAC mixed with Tritanrix™-HepB|
16357927|NCT00197262|Drug|GW685698X Aqueous Nasal Spray|
16357928|NCT00197249|Biological|Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix|
16357929|NCT00197236|Biological|Havrix™|2 intramuscular injections, 6 months apart
16357930|NCT00197236|Biological|Infanrix™|1 intramuscular injection
16357931|NCT00197236|Biological|ActHIB™|1 intramuscular injection
16357932|NCT00197223|Biological|Influenza vaccine|
16357933|NCT00197210|Biological|Rotavirus|
16357934|NCT00197197|Drug|GW873140|
16357935|NCT00197184|Biological|Twinrix™ Adult|Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
16357936|NCT00197184|Biological|Twinrix™ Junior|Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
16357937|NCT00197171|Biological|Combined Hepatitis A and B vaccine|
16357938|NCT00197158|Biological|Hepatitis B vaccine|
16357939|NCT00197145|Drug|GW873140|400 mg twice daily
16357940|NCT00197132|Drug|Avandia|
16357941|NCT00197119|Biological|Twinrix™ Adult|Intramuscular administration in the deltoid region (2 doses).
16357942|NCT00197119|Biological|Twinrix™ Junior|Intramuscular administration in the deltoid region (3 doses).
16357943|NCT00197106|Drug|Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg|comparator
16357944|NCT00197106|Drug|fluticasone propionate 2 x 100 mcg|comparator
16357945|NCT00197093|Drug|SB773812|
16357946|NCT00197080|Drug|Ropinirole Extended Release (XR)|
16357947|NCT00197067|Biological|RTS,S/AS02D and RTS,S/AS02A|
16357948|NCT00197054|Biological|RTS, S/AS01B|0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
16357949|NCT00197054|Biological|RTS, S/AS02A|0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
16357950|NCT00197054|Biological|Rabipur (Rabies) Vaccine|1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
16357951|NCT00197041|Biological|RTS,S/AS02A|
16357952|NCT00197028|Biological|RTS,S/AS02D|3-dose intramuscular injection in the thigh
16357953|NCT00197028|Biological|TETRActHib™|3-dose intramuscular injection in the thigh.
16357954|NCT00197028|Biological|Engerix-B®|3-dose intramuscular injection in the thigh.
16357955|NCT00197015|Biological|Havrix®|2 doses administered intramuscularly
16357956|NCT00197015|Biological|M-M-R®II|1 dose administered subcutaneously
16357957|NCT00197015|Biological|VARIVAX®|1 dose administered subcutaneously
16357958|NCT00197002|Biological|GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)|Two doses, administered intramuscularly in the right anterolateral thigh.
16357959|NCT00197002|Biological|Prevnar™|One dose, administered intramuscularly in the left anterolateral thigh.
16357960|NCT00196989|Drug|Pioglitazone|
16357961|NCT00196989|Drug|GW677954|
16357962|NCT00196976|Biological|Conjugated meningococcal ACWY-TT (vaccine)|One intramuscular dose during the primary vaccination
16357963|NCT00196976|Biological|DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
16358047|NCT00196339|Drug|Cyproterone acetate 25|Cyproterone acetate 25 mg
16357964|NCT00196976|Biological|DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
16357965|NCT00196976|Biological|Meningitec™|One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
16357966|NCT00196976|Biological|Mencevax™ACWY|One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
16357967|NCT00196963|Biological|Meningococcal (vaccine)|
16357968|NCT00196950|Biological|Meningococcal (vaccine)|
16357969|NCT00196937|Biological|Cervarix|Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
16357970|NCT00196924|Biological|HPV-16/18 L1/AS04|
16357971|NCT00196911|Procedure|Implantation of stimulation electrodes in the STN|
16357972|NCT00196885|Drug|N-acetylcysteine|
16357973|NCT00196872|Drug|Epirubicine|Epirbubicne is given
16357974|NCT00196872|Drug|Cyclophosphamide|Cyclophosphamide is given
16357975|NCT00196872|Drug|Taxol|Taxol is given
16357976|NCT00196872|Drug|Xeloda|Xeloda is given
16357977|NCT00196872|Drug|Ibandronat|Ibandronat is given
16357978|NCT00196859|Drug|Ibandronate, Capecitabine|Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
16357979|NCT00196859|Drug|Ibandronate|Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
16357980|NCT00196846|Drug|Goserelin|
16357981|NCT00196820|Drug|Capecitabine|
16357982|NCT00196807|Behavioral|patient decision aid (print-based)|To evaluate the impact of the decision aid intervention (information plus decision aid (IDA) vs. usual care (UC)), and timing of intervention delivery (at Home (pre-screening) vs. in the Clinic (screening day)) on key patient outcome variables of PCa knowledge and decisional satisfaction.
16357983|NCT00196794|Drug|Tolevamer potassium-sodium (GT267-004)|
16357984|NCT00196781|Behavioral|CD-ROM-based prostate cancer treatment education|The goal was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
16357985|NCT00196781|Behavioral|CD-ROM-based prostate ca treatment education+decision tools|The goal of the present study was to explore men's use of a CD-ROM-based decision aid for early-stage PCa treatment decisions.
16357986|NCT00196768|Drug|Arsenic trioxide|
16357987|NCT00196768|Drug|Trisenox|
16357988|NCT00196755|Drug|Sevelamer Hydrochloride (Renagel®)|Sevelamer hydrochloride three times per day with each meal
16357989|NCT00196755|Drug|Calcium acetate (PhosLo® )|Calcium acetate three times per day with each meal
16357990|NCT00196729|Drug|Thyrogen + Radioiodine (131I)|
16357991|NCT00196716|Biological|Fabrazyme (agalsidase beta)|1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months
16357992|NCT00196703|Drug|memantine|
16357993|NCT00196703|Procedure|constraint-induced language therapy|
16357994|NCT00196690|Drug|Donepezil|
16357995|NCT00196677|Drug|Vitamins, minerals and medical herbs|
16357996|NCT00196664|Drug|Paroxetine|
16357997|NCT00196651|Drug|IL-2|
16357998|NCT00196651|Biological|LIPO-6T|
16357999|NCT00196651|Biological|ALVAC VIH 1433|
16358000|NCT00196638|Drug|Antiretroviral combination (drugs)|
16358001|NCT00196638|Drug|Pegylated Interferon alpha (drug)|
16358002|NCT00196625|Drug|Amprenavir (drug)|
16358003|NCT00196625|Drug|ABT-378/r (drug)|
16358004|NCT00196625|Drug|Ritonavir (drug)|
16358005|NCT00196612|Drug|emtricitabine, FTC (drug)|
16358006|NCT00196612|Drug|didanosine, ddI (drug)|
16358007|NCT00196612|Drug|efavirenz (drug)|
16358008|NCT00196599|Drug|emtricitabine, FTC (drug)|
16358009|NCT00196599|Drug|didanosine, ddI (drug)|
16358010|NCT00196599|Drug|efavirenz (drug)|
16358011|NCT00196586|Drug|Interleukin 2|
16358012|NCT00196586|Drug|pegylated interferon alpha 2a|
16358013|NCT00196586|Drug|ribavirin|
16358014|NCT00196573|Procedure|Shoulder bursectomy alone|
16358015|NCT00196560|Device|Immobilization in External Rotation|
16358016|NCT00196547|Drug|Montelukast (drug)|
16358017|NCT00196534|Drug|Human Thrombin|
16358018|NCT00196534|Drug|Bovine Thrombin|
16358019|NCT00196521|Device|Tension-free vaginal tape obturator system|
16358020|NCT00196508|Device|High Viscosity DERMABOND|
16358021|NCT00196495|Device|Polypropylene Mesh|
16358022|NCT00196482|Drug|changing of fortifier|
16358023|NCT00196469|Drug|heparin|
16358024|NCT00196456|Procedure|photosensitisation|
16358025|NCT00196443|Device|urea contained compressing stockings|
16358026|NCT00196443|Device|compressing stockings|
16358027|NCT00196430|Device|silver-contained textiles|
16358028|NCT00196430|Drug|corticosteroid|
16358029|NCT00196417|Drug|Standard heparin (UFH) versus certoparin (LMWH)|
16358030|NCT00196404|Drug|DR-3001a|4mg daily vaginally
16358031|NCT00196404|Drug|DR-3001b|6 mg vaginally daily
16358032|NCT00196404|Other|Placebo|Administered vaginally to match experimental arms
16358033|NCT00196391|Drug|DR-2021a|1 capsule daily for 10 days
16358034|NCT00196391|Drug|DR-2021b|1 capsule daily for 10 days
16358035|NCT00196391|Drug|DR-2021c|1 capsule daily for 10 days
16358036|NCT00196391|Drug|DR-2021d|1 capsule daily for 10 days
16358037|NCT00196391|Drug|DR-2021e|1 capsule daily for 10 days
16358038|NCT00196391|Other|Placebo|1 matching placebo capsule for 10 days
16358039|NCT00196378|Drug|Synthetic Conjugated estrogens, B|1 (0.3mg) tablet daily
16358040|NCT00196378|Other|Placebo|1 tablet daily
16358041|NCT00196365|Drug|levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets|1 tablet daily
16358042|NCT00196365|Drug|levonorgestrel/EE 0.15/0.03 mg tablets and placebo|1 tablet daily
16358043|NCT00196352|Drug|Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets|1 tablet daily
16358044|NCT00196339|Drug|Cyproterone acetate 5|Cyproterone acetate 5 mg
16358045|NCT00196339|Drug|Placebo|Matching placebo
16358048|NCT00196326|Drug|DR-1011|Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
16358049|NCT00196313|Drug|levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets|1 tablet daily by mouth
16358050|NCT00196313|Drug|Placebo tablet|1 tablet daily by mouth
16358051|NCT00196222|Procedure|RF-ablation|RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
16358052|NCT00196222|Procedure|cryo ablation|Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
16358053|NCT00196209|Procedure|catheter ablation|catheter ablation to treat persistent atrial fibrillation
16358054|NCT00196209|Procedure|external electric cardioversion|external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
16358055|NCT00196196|Device|Codman VPV System|Valve Positioning Verification (VPV) System
16358056|NCT00196183|Procedure|trigger-guided catheter-ablation|trigger-guided ablation of paroxysmal atrial fibrillation
16358057|NCT00196183|Procedure|trigger+substrate-guided catheter ablation|trigger-+substrate guided ablation of paroxysmal atrial fibrillation
16358058|NCT00196170|Procedure|RF ablation of the cavo-tricuspid isthmus|8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
16358059|NCT00196170|Procedure|cryo ablation of the cavo-tricuspid isthmus|Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
16358060|NCT00196170|Procedure|irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus|irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
16358061|NCT00196170|Procedure|cryo 6.5mm tip ablation of the cavotricuspid isthmus|cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
16358062|NCT00196157|Procedure|linear anatomically oriented ablations|linear lesions to ablate persistent atrial fibrillation
16358063|NCT00196157|Procedure|focal electrophysiological oriented ablations|focal electrophysiologically guided ablations to treat persistent atrial fibrillation
16358064|NCT00196144|Device|Individualized Programming of PVAB|Performance of a test to detect far-field R-wave sensing
16358065|NCT00196144|Device|Nominal PVAB|nominal pacemaker settings
16358066|NCT00196131|Drug|morphine|only patients with a head injury currently receiving Morphine continuously or prm can and have an ICP drain can be enrolled into study
16358067|NCT00196118|Device|Günther Tulip Vena Cava Filter|
16358068|NCT00196105|Device|6 mm Nitinol Zilver Stent|
16358069|NCT00196105|Device|10 mm Nitinol Zilver Stent|
16358070|NCT00196105|Device|10 mm Stainless Steel Wallstent|
16358071|NCT00196092|Device|Roll-in|Proctored entry.
16358072|NCT00196092|Device|Surgical|Surgery
16358073|NCT00196092|Device|Standard Risk|Standard Endovascular repair
16358074|NCT00196092|Device|High Risk|High Risk Endovascular repair.
16358075|NCT00196092|Device|Compassionate Use|Endovascular repair for compassionate use patients.
16358076|NCT00196092|Device|Treatment for females|Endovascular repair in female patients
16358077|NCT00196092|Device|Standard Risk Continued Access|Continued Access Endovascular repair for standard risk patients.
16358078|NCT00196092|Device|High Risk Continued Access|Continued Access Endovascular Repair for High Risk Patients.
16358079|NCT00196079|Device|Coronary stent|
16358080|NCT00196066|Device|Peripheral Vessel Stenting|
16358081|NCT00196053|Device|Archimedes Constant Flow Implantable Pump|
16358082|NCT00196040|Device|PFX Closure System|
16358083|NCT00196027|Device|PFX Closure System|
16358084|NCT00195988|Drug|tacrolimus, steroids, mycophenolate mofetil|
16358085|NCT00195949|Procedure|Laparoscopic pyloromyotomy|
16358086|NCT00195936|Drug|Cinacalcet|Single oral dose of Cinacalcet for children with Hypophosphatemic Rickets
16358087|NCT00195923|Drug|Ampicillin, gentamicin, clindamycin, flagyl, ceftazidime|
16358088|NCT00195910|Drug|Morphine|0.1 mg/kg IV morphine
16358089|NCT00195910|Drug|Hydromorphone|0.015 mg/kg IV hydromorphone
16358090|NCT00195884|Behavioral|Aerobic and Resistance Exercise|"Aerobic activities are performed on a cycle ergometer or treadmill. Exercise intensity is standardized using Polar Heart rate monitors that display the subject's heart rate.
~Resistance training:Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below.
~Group A: abdominal crunches, seated row, seated biceps curls, supine bench press, leg press, shoulder press; leg extension Group B: abdominal crunches, lat pulldown, sitting chest press, leg press, upright row, triceps pushdown, leg curls.
~Combined aerobic and resistance training group will perform both aerobic and resistance training programs, as described above.
~Control: members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program."
16358091|NCT00195871|Drug|Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide|coventional dosages
16358092|NCT00195871|Procedure|hematopoietic stem cell allograft|conventional procedures
16358093|NCT00195858|Behavioral|aerobic and resistance exercise|aerobic and resistance exercise
16358094|NCT00195845|Drug|Galantamine|
16358095|NCT00195845|Drug|Placebos|
16358096|NCT00195819|Biological|adalimumab (D2E7)|Adalimumab 40 mg every other week (eow)
16358097|NCT00195819|Biological|placebo|Placebo every other week (eow)
16358098|NCT00195806|Drug|divalproex sodium|
16358099|NCT00195793|Drug|fenofibrate|
16358100|NCT00195793|Drug|ezetimibe|
16358101|NCT00195793|Drug|atorvastatin|
16358102|NCT00195780|Drug|Divalproex Sodium (Depakote ER)|
16358103|NCT00195767|Drug|divalproex sodium|
16358104|NCT00195754|Drug|divalproex sodium|
16358105|NCT00195741|Drug|divalproex sodium|
16358106|NCT00195728|Drug|Hydrocodone/Acetaminophen on Extended Release|2 tablets twice daily
16367871|NCT00112645|Drug|methotrexate|
16358107|NCT00195715|Biological|Adalimumab|Adalimumab 40 mg by subcutaneous injection every other week or every week
16358108|NCT00195702|Biological|Adalimumab|Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
16358109|NCT00195702|Biological|Adalimumab|Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.
16358110|NCT00195702|Drug|Placebo|Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
16358111|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
16358112|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.
16358113|NCT00195702|Biological|Adalimumab|Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
16358114|NCT00195689|Biological|Human anti-TNF monoclonal antibody/adalimumab|
16358115|NCT00195676|Drug|adalimumab|40 mg every other week or 40 mg every week by subcutaneous injection
16358116|NCT00195663|Biological|Adalimumab|
16358117|NCT00195663|Drug|Methotrexate|
16358118|NCT00195663|Biological|Adalimumab placebo|
16358119|NCT00195663|Drug|Methotrexate placebo|
16358120|NCT00195650|Biological|Adalimumab|Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)
16358121|NCT00195637|Drug|Immune Globulin|
16358122|NCT00195624|Biological|Alemtuzumab (Campath )|Campath administered at a dose of 10/mg/day for 10 days
16358123|NCT00195624|Drug|Cyclosporine|Subjects who relapse after initial response to alemtuzumab therapy will have cyclosporine added to the regimen after the 6 month visit. Dosing will be based on ideal body weight and will be adjusted to maintain a target level of 200 - 400 ng /ml.
16358124|NCT00195611|Drug|Prevenar|
16358125|NCT00195598|Drug|VENLAFAXINE|
16358126|NCT00195598|Drug|Paroxetine|
16358127|NCT00195585|Drug|Isovorin|
16358128|NCT00195585|Drug|UFT|
16358129|NCT00195572|Drug|Isovorin|
16358130|NCT00195572|Drug|TS-1|
16358131|NCT00195559|Drug|Levonorgestrel/Ethinyl Estradiol|
16358132|NCT00195546|Drug|DVS-233|
16358133|NCT00195533|Drug|piperacillin-tazobactam|
16358134|NCT00195533|Drug|glycopeptide|
16358135|NCT00195520|Drug|Totelle®|
16358136|NCT00195507|Drug|Etanercept|
16358137|NCT00195494|Drug|Etanercept|"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"
16358138|NCT00195494|Drug|Methotrexate|"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2
~Group 2b: Oral Methotrexate weekly for both Periods 1 and 2"
16358139|NCT00195494|Drug|Placebo|"Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"
16358140|NCT00195481|Drug|Rapamune|
16358141|NCT00195468|Drug|CYCLOSPORINE|
16358142|NCT00195455|Drug|Trimegestone|
16358143|NCT00195455|Drug|17b Estradiol|
16358144|NCT00195442|Drug|Moroctocog alfa|Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16358145|NCT00195429|Drug|Tacrolimus|
16358146|NCT00195429|Drug|Sirolimus|
16358147|NCT00195429|Drug|prednisone|
16358148|NCT00195416|Drug|Etanercept|Etanercept 25mg Injection, 2 times/week
16358149|NCT00195403|Drug|Etanercept|Etanercept 25mg Injection, 2 times/week
16358150|NCT00195390|Biological|Prevenar|Prevenar 0.5ml/ Vial and PFS
16358151|NCT00195377|Drug|Etanercept|
16358152|NCT00195364|Drug|Etanercept|
16358153|NCT00195351|Drug|tigecycline|every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
16358154|NCT00195351|Drug|ceftriaxone sodium + metronidazole|Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
16358155|NCT00195338|Drug|etanercept|
16358156|NCT00195325|Drug|TTI-237|
16358157|NCT00195312|Biological|HIV-1 gag DNA (formulated with bupivacaine)|
16358158|NCT00195312|Biological|IL-15 DNA (formulated with bupivacaine)|
16358159|NCT00195312|Biological|IL-12 DNA (formulated with bupivacaine)|
16358160|NCT00195312|Biological|Sodium chloride injection USP (0.9%)|
16358161|NCT00195299|Drug|Temsirolimus|
16358162|NCT00195286|Drug|piperacillin/tazobactam|
16358163|NCT00195273|Drug|sirolimus|15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
16358164|NCT00195273|Drug|cyclosporine|Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
16358165|NCT00195273|Drug|mycophenolate mofetil|1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
16358166|NCT00195273|Drug|corticosteroids|As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
16358167|NCT00195273|Drug|daclizumab|IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
16358168|NCT00195260|Drug|bosutinib|Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
16358169|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
16358170|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
16358171|NCT00195260|Drug|bosutinib|400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
16358172|NCT00195247|Drug|TTI-237|
16358173|NCT00195234|Biological|HIV CTL MEP 1000 micrograms, 19 months per subject|
16358174|NCT00195208|Drug|Pantoprazole for approximately 9 weeks|
16358175|NCT00195195|Drug|Sirolimus|Transplantation patients treated with sirolimus who consent to participate in the study (register)
16358176|NCT00195182|Behavioral|Self affirmation and positive affect induction vs. control|During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
16358177|NCT00195156|Drug|ATRA-IV|
16358178|NCT00195156|Drug|Depakote|
16358179|NCT00195143|Genetic|Surgical infusion of AAV-GAD into the subthalamic nucleus|
16358180|NCT00195130|Behavioral|There are no interventions in this study|
16358181|NCT00195117|Behavioral|Intervention Group|Subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
16358182|NCT00195104|Drug|Arsenic Trioxide (Tricenox)|
16358183|NCT00195104|Drug|Cytarabine|
16358184|NCT00195091|Drug|Tetrathiomolybdate|"Induction with Tetrathiomolybdate (TM) Tetrathiomolybdate 40 mg. p.o. TID with meals and tetrathiomolybdate 60 mg at bedtime for a total of 4 doses (180 mg) per day.
~Induction goal Total tetrathiomolybdate dose per day = 180 mg until serum ceruloplasmin (Cp) level decreases to 5-15mg/dL.
~When target Cp window is reached, then the maintenance phase begins.
~Maintenance with Tetrathiomolybdate Total tetrathiomolybdate dose per day = 100 mg
~Tetrathiomolybdate 40 mg p.o. BID with meals and tetrathiomolybdate 20 mg at bedtime."
16358185|NCT00195078|Drug|ZD1839 (IRESSA)|
16358186|NCT00195078|Drug|Cisplatin|
16358187|NCT00195078|Procedure|Radiation Therapy|
16358188|NCT00195065|Behavioral|Semi-structured, open-ended interviews|
16358189|NCT00195052|Diagnostic Test|Intrinsic signal imaging of human cortex|Light is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second.
16358190|NCT00195039|Drug|177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
16358191|NCT00195026|Device|Infrared Breast Scan|Patients already scheduled for breast biopsies will receive an additional infrared scan
16358192|NCT00195013|Drug|glutamine|10 grams three times a day (orally) for four days and then stop
16358193|NCT00195013|Drug|Placebo|10 grams three times a day (orally) for four days and then stop
16358194|NCT00195000|Drug|Mylotarg|6 mg/m2 on day 1
16358195|NCT00195000|Drug|Cytarabine|100 mg/m2 given as continuous infusion daily for 7 days.
16358196|NCT00194987|Drug|IVIG (Intravenous Immunoglobulin)|one gram per kg of IVIG per infusion given either once or twice
16358197|NCT00194987|Drug|prednisone|in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
16358198|NCT00194974|Drug|methyldopa|
16358199|NCT00194974|Drug|labetalol|
16358200|NCT00194974|Drug|nifedipine|
16358201|NCT00194974|Drug|clonidine|
16358202|NCT00194961|Drug|Recombinant Human Growth Hormone|
16358203|NCT00194948|Drug|escitalopram|
16358204|NCT00194948|Behavioral|interpersonal psychotherapy|
16358205|NCT00194935|Drug|Topotecan|
16358206|NCT00194922|Dietary Supplement|E. Coli Strain M17 Probiotic|30 ml PO BID for 12 weeks
16358207|NCT00194909|Drug|sildenafil (Viagra)|
16358208|NCT00194896|Drug|rosiglitazone|Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years.
16358209|NCT00194896|Drug|glyburide|Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.
16358210|NCT00194883|Drug|Recombinant Human Growth Hormone|
16358211|NCT00194870|Procedure|EEG|computer-assisted analysis of the digitally-recorded EEG signals
16358212|NCT00194857|Drug|erythropoietin, GCSF|
16358213|NCT00194844|Behavioral|Nurse Caring|Nurse Caring: Couples receive three one hour counseling session with a nurse interventionist at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
16367872|NCT00112645|Drug|methylprednisolone|
16358214|NCT00194844|Behavioral|Self Caring|Self Caring: Couples receive a mailed videotape and workbook at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
16358215|NCT00194844|Behavioral|Combined Caring|Combined Caring: Couples receive one counseling session from a nurse interventionist at approximately one week after enrollment. Upon completion of the session the nurse will hand the couple a self-caring videotape and workbook. Couples will be mailed an additional videotape and workbook at approximately 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.
16358216|NCT00194818|Drug|Asacol (mesalamine)|Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.
16358217|NCT00194805|Behavioral|Telehealth for Diabetes Self Management|
16358218|NCT00194805|Other|Telehealth for Diabetes Self Management|Web based education format delivered for a six month period
16358219|NCT00194792|Drug|exemestane|Given PO
16358220|NCT00194792|Drug|triptorelin pamoate|Given IM
16358221|NCT00194792|Drug|capecitabine|Given PO
16358222|NCT00194792|Drug|methotrexate|Given IV
16358223|NCT00194792|Drug|vinorelbine tartrate|Given IV
16358224|NCT00194792|Drug|paclitaxel|Given IV
16358225|NCT00194792|Procedure|therapeutic conventional surgery|Undergo lumpectomy or mastectomy
16358226|NCT00194792|Radiation|radiation therapy|Undergo radiation therapy
16358227|NCT00194792|Other|laboratory biomarker analysis|Correlative studies
16358228|NCT00194779|Drug|doxorubicin hydrochloride|Given IV
16358229|NCT00194779|Drug|cyclophosphamide|Given PO
16358230|NCT00194779|Drug|paclitaxel|Given IV
16358231|NCT00194779|Biological|filgrastim|Given SC
16358232|NCT00194779|Drug|capecitabine|Given PO
16358233|NCT00194779|Drug|methotrexate|Given IV
16358234|NCT00194779|Drug|vinorelbine tartrate|Given IV
16358235|NCT00194779|Procedure|needle biopsy|Correlative studies
16358236|NCT00194779|Procedure|therapeutic conventional surgery|Undergo definitive breast surgery
16358237|NCT00194779|Other|immunohistochemistry staining method|Correlative studies
16358238|NCT00194779|Biological|trastuzumab|Given IV
16358239|NCT00194779|Drug|tamoxifen citrate|Given PO
16358240|NCT00194779|Drug|letrozole|Given PO
16358241|NCT00194779|Other|laboratory biomarker analysis|Correlative studies
16358242|NCT00194766|Drug|Temozolomide|Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.
16358243|NCT00194753|Drug|Paclitaxel|80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
16358244|NCT00194753|Drug|Doxorubicin|24 mg/m2 IV weekly x 12
16358245|NCT00194753|Drug|Cyclophosphamide|60 mg/m2 PO daily for 12 weeks
16358246|NCT00194753|Drug|G-CSF|5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks
16358247|NCT00194740|Drug|Docetaxel|60 mg/m2, IV, day 1 of each 21 day cycle
16358248|NCT00194740|Drug|Vinorelbine|27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
16358249|NCT00194740|Drug|Filgrastim|5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
16358250|NCT00194727|Drug|Vinorelbine|20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
16358251|NCT00194727|Drug|Capecitabine|825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
16358252|NCT00194714|Biological|HER-2/neu Peptide Vaccine|Given ID
16358253|NCT00194714|Other|Laboratory Biomarker Analysis|Correlative studies
16358254|NCT00194701|Behavioral|Walking exercise|
16358255|NCT00194688|Drug|H. pylori treatment|
16358256|NCT00194675|Drug|Dutasteride|Dutasteride 0.5 mg orally daily
16358257|NCT00194675|Drug|Testosterone gel|Testosterone gel 7.5 g daily topical
16358258|NCT00194675|Drug|Placebo dutasteride|placebo dutasteride orally daily
16358259|NCT00194649|Drug|Miglustat (Zavesca)|100 mg Miglustat BID (twice daily) for six weeks
16358260|NCT00194636|Procedure|nerve block|
16358261|NCT00194623|Drug|Botulinum Toxin A (Botox)|
16358262|NCT00194610|Drug|Botox|Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each
16358263|NCT00194610|Other|normal saline|Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock
16358264|NCT00194597|Drug|Viagra (sildenafil citrate)|
16358265|NCT00194584|Behavioral|7 week Building on Family Strengths Program|Parents in intervention group attend a 2 hr class for seven weeks. These classes provide information, time for discussion and creation of an action plan for the parent to complete in the intervening week.
16358266|NCT00194571|Behavioral|Educational counseling intervention|This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.
16358267|NCT00194558|Behavioral|Internet co-management module|
16358268|NCT00194545|Behavioral|Medication diaries|Caregivers expected to complete medication diaries daily
16358269|NCT00194532|Drug|Cefpodoxime|Cefpodoxime 100mg twice a day(BID)for 3 days
16358270|NCT00194532|Drug|Ciprofloxacin|Ciprofloxacin 250mg twice a day (BID)for 3 days
16358271|NCT00194519|Drug|Generic acyclovir|400 mg twice-daily oral
16358272|NCT00194519|Drug|Placebo|twice-daily oral
16358273|NCT00194506|Behavioral|Internet co-management module|
16358274|NCT00194493|Behavioral|ESRA-C|Graphical summary of patient symptoms and quality of life
16358275|NCT00194480|Drug|Pegylated Interferon|Weekly injections of pegIntereferon
16358276|NCT00194467|Drug|valganciclovir|900 mg once a day for 8 weeks
16358277|NCT00194467|Drug|placebo|matching placebo, once a day for 8 weeks
16358278|NCT00194454|Behavioral|Modified cognitive behavioral therapy plus problem-solving|9 sessions with a psychosocial nurse practitioner in which participants learn to use behavioral strategies and specific problem-solving approaches to reduce or prevent behavioral and mood disturbances characteristic of stroke.
16358279|NCT00194454|Other|usual care|Usual care with primary provider plus a booklet about mood and behavioral changes following stroke
16358280|NCT00194441|Other|Bedside display of cerebral perfusion pressure information|Continually updating highly visible color coded bar graph bedside computer display of cerebral perfusion pressure
16358281|NCT00194428|Behavioral|Almond enriched diet|Subjects will consume 2 oz. of almond per day in addition to a low-fat diet
16358282|NCT00194428|Behavioral|Low fat caloric diet|Low fat caloric diet
16358283|NCT00194415|Behavioral|Safer-sex counseling|Subjects will receive safer-sex counseling during pregnancy
16358284|NCT00194415|Procedure|Type specific serologic HSV testing|Subjects will be testing for HSV by Western Blot
16358285|NCT00194402|Drug|Slo-Niacin, atorvastatin|Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.
16358286|NCT00194376|Procedure|Continuous positive airway pressure ventilation|CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea
16358287|NCT00194363|Behavioral|Strength training|13 weeks of supervised strength training (twice weekly for 90 minutes per session), 39 weeks of unsupervised strength training (twice weekly for 90 minutes per session)
16358288|NCT00194350|Procedure|Test for Factor V Leiden gene mutation|
16358289|NCT00194324|Drug|Miconazole nitrate|
16358290|NCT00194324|Procedure|Magnetic resonance imaging|
16358291|NCT00194324|Behavioral|Moderate levels of exercise|
16358292|NCT00194298|Procedure|FDG-PET Imaging|
16358293|NCT00194285|Procedure|FDG-PET Imaging|
16358294|NCT00194272|Drug|Methotrexate|Two dose methotrexate
16358295|NCT00194194|Behavioral|moderate|moderate behavioral management with RD
16358296|NCT00194194|Device|Resting Metablic Rate measurements|intensive behavior management
16358297|NCT00194181|Drug|TPA Infusion|
16358298|NCT00194129|Drug|Lithium|Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.
16358299|NCT00194129|Drug|Divalproex|Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
16358300|NCT00194129|Drug|Placebo|Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
16358301|NCT00194116|Drug|Divalproex Sodium ER|Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
16358302|NCT00194116|Drug|Placebo|. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
16358303|NCT00194103|Behavioral|Telephone Monitoring and Feedback|In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.
16358304|NCT00194103|Behavioral|Telephone Monitoring and Counseling|In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
16358305|NCT00194090|Drug|celecoxib|
16358306|NCT00194077|Drug|Aripiprazole|dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy
16358307|NCT00194077|Drug|Placebo|subjects in phase 2 will be randomized to active abilify or placebo
16358308|NCT00194064|Drug|Olanzapine|
16358309|NCT00194051|Procedure|gastric bypass surgery|
16358310|NCT00194038|Drug|Aripiprazole|Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
16358311|NCT00194025|Drug|Valproate|Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
16358312|NCT00194012|Drug|Aripiprazole|Addressed in arm description.
16358313|NCT00194012|Drug|Placebo|Addressed in arm description.
16358314|NCT00193999|Device|Placement of nasogastric tube|
16358315|NCT00193986|Device|Arbitrary Waveform Defibrillator|
16358316|NCT00193973|Drug|Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C|Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.
16358317|NCT00193973|Radiation|Radiation Therapy|Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
16358318|NCT00193960|Procedure|1) Intraocular pressure 2) visual acuity|
16358319|NCT00193921|Drug|Vinorelbine|IV, 25mg/m2, days 1, 8, 22
16358320|NCT00193921|Radiation|High dose Radiotherapy|External beam radiation, 40 Gy/20#/5 per week
16358321|NCT00193921|Drug|Gemcitabine|200mg (flat dose) IV days 1, 8, 15
16358322|NCT00193921|Drug|Cisplatin|20mg/m2, IV, weekly
16358323|NCT00193921|Radiation|High Dose Radiotherapy|External beam radiation, 30 Gy/15#/5 per week
16358398|NCT00193453|Drug|Cetuximab|100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
16358324|NCT00193908|Drug|Cavilon (TM) Durable Barrier Cream|Cavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation.
16358325|NCT00193908|Drug|Sorbolene|Sorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
16358326|NCT00193908|Radiation|Radiotherapy|Minimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
16358327|NCT00193895|Drug|Carboplatin|Carboplatin will commence with a dose calculated to target an AUC of 2.0. A maximum of 6 doses of weekly Carboplatin will be given. Carboplatin will be administered intravenously over 20-30 minutes prior to radiation therapy.
16358328|NCT00193895|Radiation|Radiotherapy|60 Gy OR 66Gy in 2Gy/fraction 5days/week
16358329|NCT00193882|Drug|Cisplatin|80mg/m2 IV day 1
16358330|NCT00193882|Radiation|Radiotherapy|35 Gy in 15 fractions
16358331|NCT00193882|Drug|5-Fluorouracil|800mg/m2/day IV days 1 - 4
16358332|NCT00193869|Drug|Dexamethasone|
16358333|NCT00193856|Drug|Leuprorelin Acetate|LH-RH analogue (LH-RHa) (Leuprorelin acetate 22.5 mg) will be delivered as a depot injection every 3 months. This will be administered as an intramuscular injection (IMI).
16358334|NCT00193856|Drug|Zoledronic Acid|Zoledronic acid 4 mg will be delivered as an intravenous infusion over 15 minutes once every 3 months for 18 months, in patients randomised to bisphosphonate therapy.
16358335|NCT00193856|Radiation|Conventional external beam therapy|The prescribed dose will be 66 Gy in 33 fractions of 2 Gy to the ICRU 50 point utilising a minimum of three fields with >= 6 MV photons.
16358336|NCT00193843|Procedure|Post-operative chemoradiotherapy / accelerated radiotherapy|
16358337|NCT00193830|Procedure|HIgh Dose Rate Vs Low DOse Rate Brachytherapy|
16358338|NCT00193817|Procedure|Two field vs Three field lymphadenectomy|
16358339|NCT00193804|Radiation|IMRT|IMRT in cervical cancers
16358340|NCT00193791|Other|CT + RT|Injection Cisplatin 40mg/m2 weekly for 5 weeks during the entire course of external radiation therapy
16358341|NCT00193778|Procedure|Surgery for breast cancer|This group will receive standard loco-regional treatment i.e. surgery (modified radical mastectomy (MRM)/ Simple SMAC/BCT) +/- radiotherapy
16358342|NCT00193778|Other|No Loco-regional treatment|This group will not receive any loco-regional treatment
16358343|NCT00193765|Procedure|Elective neck dissection in early oral cancer|Elective neck dissection in early node negative oral cancers at the time of primary surgery
16358344|NCT00193765|Procedure|Therapeutic Neck Dissection|There is no active intervention for the neck at the time of primary surgery. Therapeutic Neck Dissection at the time of nodal relapse
16358345|NCT00193752|Other|PET IMAGING|PET imaging in cervical cancers to predict, prognosticate outcome in cervical cancers
16358346|NCT00193739|Drug|NACT|3 cycles of neoadjuvant chemotherapy
16358347|NCT00193739|Procedure|Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling|NACT followed by surgery
16358348|NCT00193739|Drug|Inj.Cisplatin|Concurrent chemo radiotherapy
16358349|NCT00193739|Radiation|Concurrent chemo radiotherapy|Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.
16358350|NCT00193726|Drug|Tab Premarin (Ethinyl estradiol)|Tab Premarin 0.625 mg (Ethinyl estradiol) once a day for 5 days prior to each cycle of chemotherapy
16358351|NCT00193726|Drug|Placebo|Placebo once a day for 5 days prior to each cycle of chemotherapy
16358352|NCT00193713|Drug|bifeprunox|
16358353|NCT00193700|Drug|Testosterone Gel (1%)|
16358354|NCT00193687|Drug|bifeprunox|
16358355|NCT00193674|Drug|Dydrogesterone|20 mg/day, oral
16358356|NCT00193674|Drug|Placebo|Placebo
16358357|NCT00193661|Drug|Testosterone Gel (1%)|
16358358|NCT00193648|Drug|Rosiglitazone (Avandia)|oral drug administration
16358359|NCT00193648|Drug|Adalimumab (Humira)|Injection of drug biweekly
16358360|NCT00193635|Drug|mycophenolate mofetil|oral drug administration
16358361|NCT00193622|Drug|Bevacizumab|
16358362|NCT00193622|Drug|Erlotinib|
16358363|NCT00193609|Drug|Oxaliplatin|130 mg/m2 IV day 1 of 21 day cycle
16358364|NCT00193609|Drug|Capecitabine|1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
16358365|NCT00193596|Drug|Etoposide|50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
16358366|NCT00193596|Drug|Gemcitabine|1000 mg/m2 IV, days 1 and 8, in regimen B
16358367|NCT00193596|Drug|Irinotecan|1000 mg/m2 IV days 1 and 8 in regimen B
16358368|NCT00193596|Drug|Paclitaxel|200 mg/m2 by 1-hour IV infusion, day 1, regimen A
16358369|NCT00193596|Drug|Carboplatin|Area under the curve (AUC) 6.0 IV, day 1, regimen A
16358370|NCT00193583|Drug|Topotecan|
16358371|NCT00193583|Drug|Carboplatin|
16358372|NCT00193570|Drug|Topotecan|
16358373|NCT00193570|Drug|Docetaxel|
16358374|NCT00193557|Drug|Bortezomib|
16358375|NCT00193544|Drug|Arsenic Trioxide|
16358376|NCT00193544|Drug|Thalidomide|
16358377|NCT00193531|Drug|Paclitaxel|
16358378|NCT00193531|Drug|Carboplatin|
16358379|NCT00193531|Drug|Etoposide|
16358380|NCT00193518|Drug|Arsenic Trioxide|
16358381|NCT00193505|Drug|Ifosfamide|
16358382|NCT00193505|Drug|Carboplatin|
16358383|NCT00193505|Drug|Etoposide|
16358384|NCT00193505|Drug|Rituximab|
16358385|NCT00193505|Drug|90Y Zevalin|
16358386|NCT00193492|Drug|Bevacizumab|
16358387|NCT00193492|Drug|Rituximab|
16358388|NCT00193479|Drug|Cyclophosphamide|Cyclophosphamide
16358389|NCT00193479|Drug|Mitoxantrone|Mitoxantrone
16358390|NCT00193479|Drug|Vincristine|Vincristine
16358391|NCT00193479|Drug|Prednisone|Prednisone
16358392|NCT00193479|Drug|Rituximab|Rituximab
16358393|NCT00193466|Drug|Rituximab|
16358394|NCT00193466|Drug|Fludarabine|
16358395|NCT00193466|Drug|CAMPTH-1H|
16358396|NCT00193453|Drug|Gemcitabine|1000mg/m2 30min IV, Day 1 & 8
16358397|NCT00193453|Drug|Docetaxel|30mg/m2, 30min IV, day 1 & 8
16358399|NCT00193440|Drug|Rituximab|
16358400|NCT00193440|Drug|CHOP|
16358402|NCT00193440|Drug|Ibritumomab Tiuxetan|
16358403|NCT00193427|Drug|Docetaxel|30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
16358404|NCT00193427|Drug|Gemcitabine|1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
16358405|NCT00193427|Drug|Carboplatin|AUC = 1.5 weekly x 7
16358406|NCT00193427|Radiation|Radiation|To 63 Gy
16358407|NCT00193414|Drug|Pemetrexed|500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
16358408|NCT00193414|Drug|Gemcitabine|1500mg/m2, 30min IV
16358409|NCT00193401|Drug|Topotecan|
16358410|NCT00193388|Drug|Topotecan|
16358411|NCT00193375|Drug|Irinotecan|50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
16358412|NCT00193375|Drug|Carboplatin|AUC 5
16358413|NCT00193375|Drug|Bevacizumab|10mg/kg IV every 2 weeks for 10 doses starting week 16
16358414|NCT00193375|Radiation|Radiation|
16358415|NCT00193362|Drug|Paclitaxel|
16358416|NCT00193362|Drug|Carboplatin|
16358417|NCT00193362|Drug|Gemcitabine|
16358418|NCT00193362|Drug|Vinorelbine|
16358419|NCT00193349|Drug|Imatinib|
16358420|NCT00193349|Drug|Irinotecan|
16358421|NCT00193349|Drug|Carboplatin|
16358422|NCT00193336|Drug|ZD1839|
16358423|NCT00193323|Drug|Docetaxel|
16358424|NCT00193323|Drug|Gemcitabine|
16358425|NCT00193310|Drug|Paclitaxel|
16358426|NCT00193310|Drug|Carboplatin|
16358427|NCT00193297|Drug|Topotecan|
16358428|NCT00193297|Drug|Paclitaxel|
16358429|NCT00193297|Drug|Carboplatin|
16358430|NCT00193284|Drug|Gefitinib|
16358431|NCT00193284|Drug|Docetaxel|
16358432|NCT00193284|Drug|Carboplatin|
16358433|NCT00193284|Drug|Fluorouracil|
16358434|NCT00193271|Drug|Docetaxel|
16358435|NCT00193271|Drug|Estramustine|
16358436|NCT00193258|Drug|Bevacizumab|10mg/kg IV infusion every 2 weeks
16358437|NCT00193258|Drug|Erlotinib|150 mg po daily
16358438|NCT00193258|Drug|Imatinib|400-600mg daily
16358439|NCT00193245|Drug|Topotecan|
16358440|NCT00193245|Drug|Docetaxel|
16358441|NCT00193232|Drug|Docetaxel|
16358442|NCT00193232|Drug|Bortezomib|
16358443|NCT00193219|Drug|Bevacizumab|5 mg/kg IV
16358444|NCT00193219|Drug|Cetuximab|400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8
16358445|NCT00193219|Drug|5-fluorouracil|400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)
16358446|NCT00193219|Drug|Leucovorin|350 mg IV
16358447|NCT00193219|Drug|Oxaliplatin|85 mg/m2 IV
16358448|NCT00193206|Drug|Gemcitabine|Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
16358449|NCT00193206|Drug|Epirubicin|Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
16358450|NCT00193206|Drug|Albumin-bound Paclitaxel|ABI-007 175 mg/m2 D1 q 14 days x 6 cycles
16358451|NCT00193193|Drug|Paclitaxel|
16358452|NCT00193193|Drug|Estramustine|
16358453|NCT00193193|Drug|Carboplatin|
16358454|NCT00193180|Drug|Imatinib|Imatinib
16358455|NCT00193180|Drug|Docetaxel|Docetaxel
16358456|NCT00193167|Drug|Topotecan|
16358457|NCT00193154|Drug|OSI-774|150mg PO, days 1-28, cycle repeated every 28 days
16358458|NCT00193154|Drug|Bevacizumab|10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
16358459|NCT00193141|Drug|Paclitaxel|
16358460|NCT00193141|Drug|Carboplatin|
16358461|NCT00193141|Drug|5-Fluorouracil|
16358462|NCT00193128|Drug|Oxaliplatin|40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
16358463|NCT00193128|Drug|Docetaxel|20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
16358464|NCT00193128|Drug|Capecitabine|In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
16358465|NCT00193128|Radiation|Radiation therapy|In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
16358466|NCT00193115|Drug|Docetaxel|
16358467|NCT00193115|Drug|Doxorubicin|
16358468|NCT00193115|Drug|Cyclophosphamide|
16358469|NCT00193102|Drug|Thalidomide|Thalidomide
16358470|NCT00193102|Drug|Capecitabine|Capecitabine
16358471|NCT00193089|Drug|Docetaxel|Docetaxel
16358472|NCT00193089|Drug|Vinorelbine|Vinorelbine
16358473|NCT00193089|Drug|Trastuzumab|Trastuzumab
16358474|NCT00193076|Drug|Gemcitabine|Gemcitabine
16358475|NCT00193076|Drug|Carboplatin|Carboplatin
16358476|NCT00193076|Drug|Trastuzumab|Trastuzumab
16358477|NCT00193063|Drug|Trastuzumab|Trastuzumab
16358478|NCT00193063|Drug|Gemcitabine|Gemcitabine
16358482|NCT00193037|Drug|Liposomal Doxorubicin|Liposomal Doxorubicin
16358483|NCT00193037|Drug|Docetaxel|Docetaxel
16358484|NCT00193024|Drug|Docetaxel|
16358485|NCT00193024|Drug|Epirubicin|
16358486|NCT00193011|Drug|Docetaxel|Docetaxel
16358487|NCT00193011|Drug|Cyclophosphamide|Cyclophosphamide
16358488|NCT00193011|Drug|Methotrexate|Methotrexate
16358489|NCT00193011|Drug|5-Fluorouracil|5-Fluorouracil
16358490|NCT00192985|Device|Nitrofuranzone coated bladder catheter|
16358491|NCT00192972|Procedure|Catheter ablation (pulmonary vein isolation)|
16358492|NCT00192959|Drug|Xenon vs propofol|
16358493|NCT00192946|Procedure|Temporary cardiac resynchronization therapy|
16358494|NCT00192933|Procedure|NovoSeven treatment according to guideline|
16358495|NCT00192920|Behavioral|Transfusion practice|
16358496|NCT00192881|Device|Bx Sonic & Cypher stent from Cordis|
16358497|NCT00192868|Procedure|Distal protection and drug eluting stent|
16358498|NCT00192855|Drug|Entacapone|Entacapone 600mg BID
16358499|NCT00192842|Drug|curcumin (+ gemcitabine)|
16358500|NCT00192829|Procedure|Blood sample withdrawal|
16358501|NCT00192816|Behavioral|reaction to pain|
16358502|NCT00192803|Drug|candesartan|
16358503|NCT00192777|Drug|Xeloda|
16358504|NCT00192777|Procedure|External Beam Radiotherapy|
16358505|NCT00192764|Drug|high-dose cyclophosphamide|
16358506|NCT00192751|Behavioral|Psychoeducational group sessions|
16358507|NCT00192725|Other|rapid tryptophan depletion|Amino-acid mixture without tryptophan
16358508|NCT00192712|Drug|irinotecan, gemcitabine|
16358509|NCT00192699|Device|Bimetric femoral stem|Cemented Bi-Metric femoral stem
16358510|NCT00192686|Procedure|culture a.m. Kamme-Lindberg|
16358511|NCT00192673|Drug|PEG-asparaginase|
16358512|NCT00192660|Drug|Lamivudine|
16358513|NCT00192660|Drug|Stavudine|
16358514|NCT00192660|Drug|Didanosine|
16358515|NCT00192660|Drug|Zidovudine|
16358516|NCT00192660|Drug|Tenofovir|
16358517|NCT00192660|Drug|Abacavir|
16358518|NCT00192660|Drug|Efavirenz (EFV)|
16358519|NCT00192660|Drug|Nevirapine|
16358520|NCT00192660|Drug|Indinavir|
16358521|NCT00192660|Drug|Saquinavir|
16358522|NCT00192660|Drug|Amprenavir|
16358523|NCT00192660|Drug|Ritonavir|
16358524|NCT00192660|Drug|Nelfinavir|
16358525|NCT00192660|Drug|Tipranavir|
16358526|NCT00192660|Drug|enfuvirtide (T20)|
16358527|NCT00192647|Drug|PEG-IFN alfa-2a|PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
16358528|NCT00192647|Drug|Ribavirin|Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
16358529|NCT00192634|Drug|Emtricitabine 200mg - Tenofovir 300mg|1 tablet once daily for 96 weeks
16358530|NCT00192634|Drug|Abacavir 600mg - Lamivudine 300mg|1 tablet once daily for 96 weeks
16358531|NCT00192621|Drug|Combivir (zidovudine [AZT] / lamivudine [3TC])|
16358532|NCT00192621|Drug|Kaletra (lopinavir [LPVr])|
16358533|NCT00192608|Drug|saquinavir 500 formulation|NRTIs + SQV/RTV 1000/100 mg BID using 200 mg SQV capsules switched at entry to ATV/SQV/RTV 300/1500/100 mg QD using 500 mg SQV tablet for 48 weeks with PK at days 0 and 8.
16358534|NCT00192608|Drug|cross-over arm|either ATV/SQV/RTV 300/1500/100 QD (500 mg SQV tabs) for 7 days then after PK SQV changed to 1600 mg QD (200 mg caps) with PK day 15, or ATV/SQV/RTV 300/1600/100 QD for 7 days with switch to SQV 1500 mg QD. After day 15 PK both groups switch to ATV/SQV/RTV 300/1500/100 QD to week 48
16358535|NCT00192595|Drug|Tenofovir|
16358536|NCT00192595|Drug|Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)|
16358537|NCT00192582|Behavioral|Motivational Interview with care plan and education|
16358538|NCT00192569|Drug|Pegylated Interferon alfa 2a|PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
16358539|NCT00192569|Drug|Ribavirin (HIV conifected patients only)|"genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg)
~Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients"
16358540|NCT00192556|Behavioral|food|
16358541|NCT00192543|Behavioral|diet of fish and fruit|fish and fruit in specified quantities
16358542|NCT00192543|Behavioral|fruit and fish|no drugs
16358543|NCT00192543|Behavioral|diet only|Fish and fruit
16358544|NCT00192543|Behavioral|regular diet|no change in regular diet
16358545|NCT00192517|Drug|MEDI-522|4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
16358546|NCT00192517|Other|Placebo|4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
16358547|NCT00192504|Biological|Motavizumab|Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
16358548|NCT00192504|Biological|Motavizumab|Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
16358549|NCT00192504|Biological|Motavizumab|Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
16358550|NCT00192504|Other|Placebo|Single dose of placebo administered intravenously (in the vein) on Day 0
16358551|NCT00192491|Biological|FluMist|Nasal Sprayer of one dosage of FluMist and other experimental
16358552|NCT00192491|Biological|FluMist|Nasal sprayer of FluMist
16358553|NCT00192491|Other|Placebo|Nasal Sprayer of Placebo
16358554|NCT00192478|Biological|Medi-524|IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
16358555|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp.1: 3 mg/kg IV (single dose)
16358556|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 2: 15 mg/kg IV (single dose)
16358557|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 3: 30 mg/kg IV (single dose)
16358558|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp. 4: 3 mg/kg IM (single dose)
16358559|NCT00192465|Biological|MEDI-524 (Numax-TM)|Grp.5: 3 mg/kg IM (two doses)
16358560|NCT00192452|Drug|MEDI-507|
16358561|NCT00192439|Behavioral|High Risk Respiratory Disease|
16358562|NCT00192426|Biological|CAIV-T|
16358563|NCT00192413|Biological|Cold-adapted influenza vaccine trivalent (CAIV-T)|Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.
16358564|NCT00192413|Biological|Trivalent Inactivated Vaccine (TIV)|Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).
16358565|NCT00192400|Biological|CAIV-T|
16358566|NCT00192387|Biological|CAIV-T, Liquid|
16358567|NCT00192374|Biological|CAIV-T, Liquid|
16358568|NCT00192361|Biological|CAIV-T|
16358569|NCT00192348|Biological|CAIV-T|
16358570|NCT00192335|Biological|CAIV-T|
16358571|NCT00192335|Biological|CAIVT|The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
16358572|NCT00192335|Biological|FluMist|The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
16358573|NCT00192322|Biological|CAIV-T 10^7|a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
16358574|NCT00192322|Biological|CAIVT 10^5|a single intranasal 0.2 mL dose of CAIV-T <10^5
16358575|NCT00192322|Biological|Placebo|a single intranasal 0.2 mL dose of placebo
16358576|NCT00192322|Biological|TIV|commercially available TIV injected intramuscularly
16358577|NCT00192309|Biological|CAIV-T|Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains. The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified. Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.
16358578|NCT00192309|Biological|TIV|TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA. Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.
16358579|NCT00192309|Biological|Placebo|Placebo in this study consisted of physiological saline. The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
16358580|NCT00192296|Biological|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
16358581|NCT00192296|Biological|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
16358582|NCT00192296|Biological|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
16358583|NCT00192296|Biological|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
16358584|NCT00192283|Biological|CAIV-T|The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
16358585|NCT00192283|Other|Placebo|A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
16358586|NCT00192270|Biological|CAIV-T|Each dose of the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose.
16358587|NCT00192257|Biological|CAIV-T and TIV|
16358588|NCT00192244|Biological|CAIV-T, Liquid|
16358589|NCT00192231|Biological|CAIV-T|
16358590|NCT00192218|Biological|FluMist|0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type
16358591|NCT00192205|Biological|CAIV-T or TIV|
16358592|NCT00192192|Biological|CAIV-T|
16358593|NCT00192179|Biological|Cold-adapted influenza vaccine trivalent (CAIV-T)|The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
16358594|NCT00192179|Biological|Placebo|The placebo consisted of physiologic normal saline.
16358595|NCT00192166|Biological|CAIV-T|
16358596|NCT00192153|Biological|CAIV-T or TIV|
16358597|NCT00192140|Biological|FluMist|A single intranasal dose of FluMist will be administered to approx. 300 subjects.
16358598|NCT00192127|Biological|FluMist|A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
16358599|NCT00192127|Other|Placebo|A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0
16358600|NCT00192114|Drug|Enzastaurin HCl|1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles.
16358601|NCT00192101|Drug|gemcitabine|
16358602|NCT00192101|Drug|cisplatin|
16358603|NCT00192088|Drug|pemetrexed|
16358604|NCT00192088|Drug|oxaliplatin|
16358605|NCT00192075|Drug|Gemcitabine|900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression.
16358606|NCT00192075|Drug|avastin|5 milligrams per kilogram (mg/kg)
16358607|NCT00192075|Drug|5FU/folinic acid|"Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).
~Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).
~5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4)."
16358608|NCT00192075|Drug|oxaliplatin|85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
16358609|NCT00192062|Drug|gemcitabine|
16358610|NCT00192062|Drug|vinorelbine|
16358611|NCT00192049|Drug|Gemcitabine|
16358612|NCT00192049|Drug|mitomycin C|
16358613|NCT00192036|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)
16358614|NCT00192036|Drug|cisplatin|80 mg/m2, IV, every 21 days x 5 cycles
16358615|NCT00192036|Radiation|radiation|63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
16358616|NCT00192023|Drug|atomoxetine 0.5 mg/kg/day|atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
16358617|NCT00192023|Drug|placebo|
16358618|NCT00192023|Drug|atomoxetine 1.2 mg/kg/day|atomoxetine 1.2 mg/kg/day QD, PO
16358619|NCT00192023|Drug|atomoxetine 1.2-1.4 mg/kg/day|atomoxetine 1.2 - 1.4 mg/kg/day QD, PO
16358620|NCT00191997|Drug|Olanzapine|
16358621|NCT00191984|Drug|pemetrexed|400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
16358622|NCT00191984|Drug|irinotecan|180 mg/m^2, intravenous (IV), every 14 days x 12 cycles
16358623|NCT00191971|Drug|Gemcitabine|
16358624|NCT00191945|Drug|Atomoxetine Hydrochloride|
16358627|NCT00191919|Drug|Duloxetine Hydrochloride|
16358628|NCT00191919|Drug|Placebo|
16358629|NCT00191906|Drug|Atomoxetine Hydrochloride|Atomoxetine, 1.2 mg/kg/day, by mouth (PO)
16358630|NCT00191906|Drug|placebo|Placebo, every day (QD), by mouth (PO)
16358631|NCT00191893|Drug|teriparatide|
16358632|NCT00191880|Drug|atomoxetine|
16358633|NCT00191867|Drug|Teriparatide|
16358634|NCT00191854|Drug|gemcitabine|2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
16358635|NCT00191854|Drug|paclitaxel|150 mg/m2, IV, every 14 days x 8 cycles
16358636|NCT00191854|Drug|carboplatin|Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
16358637|NCT00191854|Drug|cisplatin|50 mg/m2, IV, every 14 days x 8 cycles
16358638|NCT00191841|Drug|gemcitabine|
16358639|NCT00191841|Drug|Cisplatin|
16358640|NCT00191828|Drug|olanzapine|
16358641|NCT00191815|Drug|Gemcitabine|Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
16358642|NCT00191815|Drug|cisplatin|Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
16358643|NCT00191802|Drug|teriparatide|
16358644|NCT00191789|Drug|gemcitabine|1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)
16358645|NCT00191789|Drug|doxorubicin|60 mg/m^2, IV, every 21 days x 4 cycles (1-4)
16358646|NCT00191789|Drug|cisplatin|70 mg/m^2, IV, every 21 days x 4 cycles (5-8)
16358647|NCT00191789|Procedure|surgery|Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
16358648|NCT00191763|Drug|Gemcitabine|
16358649|NCT00191763|Drug|cisplatin|
16358650|NCT00191750|Drug|Pemetrexed|
16358651|NCT00191737|Drug|Atomoxetine|
16358652|NCT00191724|Drug|Drotrecogin Alfa (Activated)|6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
16358653|NCT00191724|Drug|Enoxaparin|1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
16358654|NCT00191724|Drug|Placebo|intravenous (IV), one infusion, over 12 hours
16358655|NCT00191724|Drug|Drotrecogin Alfa (Activated)|12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
16358656|NCT00191724|Drug|Drotrecogin Alfa (Activated)|18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
16358657|NCT00191724|Drug|Drotrecogin Alfa (Activated)|24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
16358658|NCT00191711|Drug|Gemcitabine|
16358659|NCT00191698|Drug|atomoxetine hydrochloride|
16358660|NCT00191698|Drug|placebo|
16358661|NCT00191685|Drug|duloxetine|
16358662|NCT00191672|Drug|Gemcitabine|
16358663|NCT00191672|Drug|Paclitaxel|
16358664|NCT00191672|Drug|Docetaxel|
16358665|NCT00191659|Drug|Atomoxetine Hydrochloride|
16358666|NCT00191646|Drug|Gemcitabine|"1000 mg/m^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles
~If anything other than complete response in Paclitaxel arm patients, 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity"
16358667|NCT00191646|Drug|Paclitaxel|"175 mg/m^2, IV, Day 1, q 21 days x 6 cycles
~If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m^2, IV, 3 hours q 28 days x 12 cycles (1 year)
~If no complete response, then Gemcitabine arm patients may receive 175 mg/m^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity"
16358668|NCT00191646|Drug|Carboplatin|"Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles
~Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles"
16358669|NCT00191633|Drug|Atomoxetine|
16358670|NCT00191620|Drug|Gemcitabine|
16358671|NCT00191620|Drug|cisplatin|
16358672|NCT00191607|Drug|Gemcitabine|
16358673|NCT00191607|Drug|liposomal doxorubicin|
16358674|NCT00191594|Drug|Duloxetine Hydrochloride|
16358675|NCT00191581|Drug|Humalog Mix 50|
16358676|NCT00191581|Drug|Human Insulin Mix 50:50|
16358677|NCT00191568|Drug|Gemcitabine|
16358678|NCT00191568|Drug|Oxaliplatin|
16358679|NCT00191568|Procedure|Radiotherapy|
16358680|NCT00191555|Drug|olanzapine|
16358681|NCT00191555|Drug|haloperidol|
16358682|NCT00191542|Drug|Atomoxetine|
16358683|NCT00191542|Drug|Placebo|
16358684|NCT00191529|Drug|somatropin|
16358685|NCT00191516|Drug|Atomoxetine|
16358686|NCT00191503|Drug|Pemetrexed|
16358687|NCT00191503|Drug|Gemcitabine|
16358688|NCT00191490|Drug|Gemcitabine|
16358689|NCT00191490|Drug|docetaxel|
16358690|NCT00191490|Drug|cisplatin|
16358691|NCT00191477|Drug|Gemcitabine|2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
16358692|NCT00191477|Drug|Placebo|intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
16358693|NCT00191464|Drug|premeal insulin lispro mixtures|
16358694|NCT00191464|Drug|insulin glargine|
16358695|NCT00191464|Drug|metformin|
16358696|NCT00191451|Drug|Gemcitabine|Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
16358697|NCT00191451|Drug|Carboplatin|Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
16358698|NCT00191451|Drug|Herceptin|"Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).
~Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
16358699|NCT00191438|Drug|gemcitabine|
16358700|NCT00191438|Drug|capecitabine|
16358701|NCT00191438|Drug|docetaxel|
16358702|NCT00191425|Drug|Teriparatide|
16358703|NCT00191425|Drug|Raloxifene|
16358704|NCT00191412|Drug|Pemetrexed|
16358705|NCT00191399|Drug|Olanzapine|
16358707|NCT00191386|Drug|Atomoxetine hydrochloride|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
16358708|NCT00191373|Drug|Gemcitabine|
16358709|NCT00191373|Drug|Trastuzumab|
16358710|NCT00191360|Drug|Somatropin|
16358711|NCT00191347|Drug|pemetrexed|
16358712|NCT00191347|Drug|gemcitabine|
16358713|NCT00191334|Drug|gemcitabine|1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
16358714|NCT00191334|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
16358715|NCT00191321|Drug|Teriparatide|
16358716|NCT00191308|Drug|pemetrexed|500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
16358717|NCT00191308|Drug|cisplatin|75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
16358718|NCT00191308|Procedure|Radical Non-Small Cell Lung Cancer (NSCLC) surgery|All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
16358719|NCT00191295|Drug|Atomoxetine|
16358720|NCT00191295|Drug|Placebo|
16358721|NCT00191282|Drug|Insulin lispro|Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study
16358722|NCT00191282|Drug|Human insulin isophane suspension (NPH)|Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%
16358723|NCT00191282|Drug|Insulin glargine|Insulin glargine injected subcutaneous (SC) once daily in the evening until patient completes study.
16358724|NCT00191282|Drug|Human insulin isophane suspension|Patient adjusted dose, twice daily, injected subcutaneous (SC) before morning and evening meals until patient completes study.
16358725|NCT00191282|Drug|Human insulin 30/70|Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
16358726|NCT00191269|Drug|gemcitabine|1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
16358727|NCT00191269|Drug|gemcitabine|1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
16358728|NCT00191256|Drug|Gemcitabine|
16358729|NCT00191256|Drug|Carboplatin|
16358730|NCT00191256|Drug|Paclitaxel|
16358731|NCT00191243|Drug|Gemcitabine|"A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
~B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure"
16358732|NCT00191243|Drug|docetaxel|"A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
~B: 80 mg/m2, IV, q 21 days until treatment failure"
16358733|NCT00191230|Drug|gemcitabine|
16358734|NCT00191230|Drug|carboplatin|
16358735|NCT00191230|Drug|cisplatin|
16358736|NCT00191204|Drug|Duloxetine|
16358737|NCT00191191|Drug|Pemetrexed 500 mg/m2|500 mg/m2, intravenous (IV), every 21 days, one year from registration date
16358738|NCT00191191|Drug|Pemetrexed 1000 mg/m2|1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
16358739|NCT00191178|Drug|insulin lispro protamine suspension:insulin lispro rDNA origin low mix|
16358740|NCT00191178|Drug|insulin glargine|
16358741|NCT00191165|Drug|Somatropin|Doubled dosage with respect to the pre-enrollment (in-label) dosage
16358742|NCT00191165|Drug|Somatropin|In-label dosage
16358743|NCT00191152|Drug|gemcitabine|1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
16358744|NCT00191152|Drug|docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression
16358745|NCT00191152|Drug|capecitabine|1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
16358746|NCT00191139|Drug|gemcitabine|After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.
16358747|NCT00191139|Drug|docetaxel|Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
16358748|NCT00191139|Drug|cisplatin|As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)
16358749|NCT00191139|Drug|etoposide|As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)
16358750|NCT00191139|Radiation|radiation therapy|In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks
16358751|NCT00191126|Drug|gemcitabine|1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
16358752|NCT00191126|Drug|Cisplatin|75 mg/m2, IV, q 21 days x 3 cycles
16358753|NCT00191126|Procedure|surgery|surgery
16358754|NCT00191113|Drug|Somatropin|0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
16358755|NCT00191113|Drug|Ethinyl estradiol|escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.
16358756|NCT00191113|Drug|Medroxyprogesterone acetate|10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
16358757|NCT00191100|Drug|Gemcitabine|
16358758|NCT00191100|Drug|Cisplatin|
16358759|NCT00191100|Radiation|Brachytherapy|Brachytherapy, 30-35 Gy over 1 week
16358760|NCT00191100|Radiation|Pelvic radiation|Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
16358761|NCT00191087|Drug|Duloxetine|
16358762|NCT00191074|Drug|somatropin, rDNA origin, for injection|
16358763|NCT00191061|Drug|duloxetine hydrochloride|
16358764|NCT00191048|Drug|Atomoxetine|
16358765|NCT00191035|Drug|Atomoxetine|
16358766|NCT00191022|Drug|LY686017|
16358767|NCT00191022|Drug|paroxetine|
16358768|NCT00191022|Drug|placebo|
16358769|NCT00191009|Drug|atomoxetine hydrochloride|
16358770|NCT00191009|Drug|placebo|
16358771|NCT00190996|Drug|Duloxetine Hydrochloride|
16358772|NCT00190996|Drug|placebo|
16358773|NCT00190983|Drug|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
16358774|NCT00190970|Drug|Ruboxistaurin|
16358775|NCT00190957|Drug|Atomoxetine|
16358776|NCT00190957|Drug|placebo|
16358777|NCT00190944|Drug|Teriparatide|
16358778|NCT00190944|Drug|placebo|
16358779|NCT00190931|Drug|Atomoxetine Hydrochloride|
16358780|NCT00190931|Drug|placebo|
16358781|NCT00190918|Drug|Pemetrexed|
16358782|NCT00190905|Drug|duloxetine HCl|
16358783|NCT00190892|Drug|olanzapine|
16358784|NCT00190892|Drug|carbamazepine|
16358785|NCT00190879|Drug|Atomoxetine hydrochloride|
16358786|NCT00190879|Drug|placebo|
16358787|NCT00190866|Drug|Duloxetine|
16358788|NCT00190866|Drug|placebo|
16358789|NCT00190853|Drug|Duloxetine|
16358790|NCT00190840|Drug|pemetrexed|
16358791|NCT00190827|Drug|duloxetine|
16358792|NCT00190827|Drug|placebo|
16358793|NCT00190814|Drug|duloxetine|
16358794|NCT00190814|Drug|placebo|
16358795|NCT00190801|Drug|pemetrexed|
16358796|NCT00190801|Drug|cisplatin|
16358797|NCT00190788|Drug|Drotrecogin Alfa (Activated)|
16358798|NCT00190788|Drug|placebo|
16358799|NCT00190775|Drug|Atomoxetine Hydrochloride|Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
16358800|NCT00190775|Drug|Placebo|Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.
16358801|NCT00190762|Drug|Pemetrexed|
16358802|NCT00190749|Drug|olanzapine|5-20 mg, oral, capsules, daily, 12 weeks.
16358803|NCT00190749|Drug|risperidone|2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
16358804|NCT00190736|Drug|Atomoxetine Hydrochloride|
16358805|NCT00190736|Drug|placebo|
16358806|NCT00190723|Drug|Enzastaurin|
16358807|NCT00190710|Drug|Gemcitabine|
16358808|NCT00190710|Drug|Carboplatin|
16358809|NCT00190697|Drug|arzoxifene|
16358810|NCT00190684|Drug|atomoxetine|0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
16358811|NCT00190671|Drug|pemetrexed|Pemetrexed: 600 mg/m2, intravenous (IV), every 21 days x 8 cycles
16358812|NCT00190671|Drug|cyclophosphamide|600 mg/m2, intravenous (IV), every 21 days x 8 cycles
16358813|NCT00190671|Drug|pemetrexed|1800 mg/m2, intravenous (IV), every 21 days x 8 cycles
16358814|NCT00190658|Drug|Somatropin (rDNA origin) for injection|
16358815|NCT00190645|Drug|Duloxetine|
16358816|NCT00190632|Drug|Duloxetine|
16358817|NCT00190619|Drug|Duloxetine|
16358818|NCT00190619|Drug|Placebo|
16358819|NCT00190606|Drug|Duloxetine|
16358820|NCT00190606|Procedure|Pelvic Floor Muscle Training (PFMT)|
16358821|NCT00190606|Procedure|Imitation PFMT|
16358822|NCT00190606|Drug|placebo|
16358823|NCT00190593|Drug|raloxifene|
16358824|NCT00190593|Drug|placebo|
16358825|NCT00190580|Drug|valsartan|valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
16358826|NCT00190580|Drug|Conventional antihypertensive drugs|Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
16358827|NCT00190567|Drug|duloxetine|
16358828|NCT00190567|Drug|Placebo|
16358829|NCT00190554|Drug|Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2|
16358830|NCT00190554|Drug|(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery|
16358831|NCT00190541|Procedure|Mesorectal excision with lateral lymph node dissection|Mesorectal excision with lateral lymph node dissection
16358832|NCT00190541|Procedure|Mesorectal excision without lateral lymph node excision|Mesorectal excision without lateral lymph node excision
16358833|NCT00190528|Drug|neoadjuvant chemotherapy + radical hysterectomy|
16358834|NCT00190528|Procedure|radical hysterectomy|
16358835|NCT00190515|Drug|5FU+l-leucovorin|5FU+l-leucovorin
16358836|NCT00190515|Drug|UFT+Leucovorin|UFT+Leucovorin
16358837|NCT00190502|Drug|Polyclonal anti-T-cell antibodies|
16358838|NCT00190489|Drug|AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles|
16358839|NCT00190489|Drug|Docetaxel 60mg/m2 every 21 days for 6 cycles|
16358840|NCT00190489|Drug|AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles|
16358841|NCT00190476|Drug|Weekly docetaxel alone|
16358842|NCT00190476|Drug|Weekly docetaxel + cisplatin combination|
16358843|NCT00190463|Drug|Amphotericin B|
16358844|NCT00190450|Biological|graft intracerebral of foetal neurons|graft intracerebral of foetal neurons
16358845|NCT00190437|Drug|Amoxicillin-clavulanic|Amoxicillin-clavulanic
16358846|NCT00190424|Drug|CpG-ODN|
16358847|NCT00190411|Drug|celiprolol|celiprolol
16358848|NCT00190411|Drug|Control|Untreated controls excluding betablockers
16358849|NCT00190398|Device|Carotid angioplasty and stenting with cerebral protection|Carotid angioplasty and stenting with cerebral protection
16358850|NCT00190385|Procedure|Ultrasonographic screening|Ultrasonographic screening
16358851|NCT00190372|Behavioral|Controlled diet|Controlled diet
16358852|NCT00190372|Behavioral|Self-hypnotic relaxation|Self-hypnotic relaxation
16358853|NCT00190346|Device|Humidification devices: HH vs HME|
16358854|NCT00190333|Drug|escitalopram|escitalopram
16358855|NCT00190320|Procedure|Induction of labor vs waiting|
16358856|NCT00190307|Drug|aspirin 75 mg/day|aspirin 75 mg/day
16358857|NCT00190294|Drug|MIFEPRISTONE 200 mg and misoprostol 400 µg|MIFEPRISTONE 200 mg and misoprostol 400 µg
16358858|NCT00190268|Drug|3,4-diaminopyridine|3,4-diaminopyridine
16358859|NCT00190255|Procedure|CY2PC9 genotyping|CY2PC9 genotyping
16358860|NCT00190242|Drug|group1|Havrix at 1440IU was administrated à weeks S0, S4 and S24
16358861|NCT00190242|Drug|group2|Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
16358862|NCT00190229|Drug|Cyclophosphamide|Cyclophosphamide
16358863|NCT00190216|Device|Magnetic stimulator|
16358864|NCT00190203|Procedure|Decompressive hemicraniectomy and duraplasty|Decompressive hemicraniectomy and duraplasty
16358865|NCT00190203|Procedure|hemicraniectomy|hemicraniectomy
16358866|NCT00190190|Procedure|With Peeling of Limiting the Intern of the Retina|With Peeling of Limiting the Intern of the Retina
16358867|NCT00190190|Procedure|Internal limiting membrane peeling|Traditional Procedure Without Peeling of Limiting
16358868|NCT00190164|Procedure|Macular hole surgery with alleviated positioning|Macular hole surgery with alleviated positioning
16358869|NCT00190164|Procedure|Macular hole surgery with no alleviated positioning|Macular hole surgery with no alleviated positioning
16358870|NCT00190151|Drug|ciprofloxacin|
16358871|NCT00190138|Device|Bi-ventricular pacing|
16358872|NCT00190112|Procedure|ventral cardiac denervation|
16358873|NCT00190099|Device|Dexamethasone-Eluting Stent|
16358874|NCT00190060|Drug|Transdermal testosterone gel (Testogel 1% )|Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
16358875|NCT00190060|Drug|Matched transdermal placebo gel|Matched transdermal placebo gel, 50mg/d for 6 months
16358876|NCT00190047|Drug|DP-b99|
16358877|NCT00190034|Drug|N-Acetylcysteine 600mg/tab|
16358878|NCT00190021|Drug|donepezil|
16358879|NCT00190008|Drug|piracetam|
16358880|NCT00189995|Drug|clozapine|
16358881|NCT00189995|Drug|haloperidol|
16358882|NCT00189982|Drug|Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)|"Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change.
~The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care."
16358883|NCT00189969|Biological|Elstree-BN|
16358884|NCT00189956|Biological|IMVAMUNE (MVA-BN)|Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
16358885|NCT00189943|Biological|MVA-BN|
16358886|NCT00189930|Biological|MVA-nef|3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
16358887|NCT00189930|Biological|IMVAMUNE|3 immunizations: 1E8_TCID50 IMVAMUNE
16358888|NCT00189917|Biological|IMVAMUNE (MVA-BN)|1x10E08 TCID50, subcutaneous vaccination
16358889|NCT00189904|Biological|IMVAMUNE (MVA-BN)|
16358890|NCT00189878|Drug|Methotrexate (drug)|Methotrexate 10 to 15 mg weekly for 8 weeks
16358891|NCT00189878|Drug|placebo capsules|4-6 placebo capsules - identical to capsules containing methotrexate
16358892|NCT00189852|Device|Chronic heart failure monitoring system|
16358893|NCT00189852|Device|Lifestyle monitoring system|
16358894|NCT00189839|Drug|tacrolimus|Immunosuppression
16358895|NCT00189826|Drug|tacrolimus|immunosuppression
16358896|NCT00189813|Drug|YM060|
16358897|NCT00189800|Drug|Solifenacin succinate|
16358898|NCT00189787|Drug|tacrolimus|
16358899|NCT00189774|Drug|nateglinide|
16358900|NCT00189761|Drug|Tacrolimus|
16358901|NCT00189748|Drug|Tacrolimus|
16358902|NCT00189735|Drug|FK778|
16358903|NCT00189722|Drug|Tacrolimus|
16358904|NCT00189709|Drug|Micafungin|IV
16358905|NCT00189709|Drug|fluconazole|IV
16358906|NCT00189696|Drug|YM060|
16358907|NCT00189683|Procedure|Monitoring|
16358908|NCT00189683|Procedure|Xeloda|
16358909|NCT00189670|Procedure|6 TEC q 3 weeks|
16358910|NCT00189670|Procedure|4 EC q 2 weeks followed by 4 TXT q 2 weeks|
16358911|NCT00189670|Procedure|4 TXT q 2 weeks followed by 4 EC q 2 weeks|
16358912|NCT00189657|Procedure|5FU/LV Mayo Clinic or LV5FU2|
16358913|NCT00189657|Procedure|LV5FU2 + irinotecan|
16358914|NCT00189644|Procedure|6 FEC 100|
16358915|NCT00189644|Procedure|4 FEC 100 followed by 4 Taxol|
16358916|NCT00189631|Procedure|UFT/LV|
16358917|NCT00189631|Procedure|Observation|
16358918|NCT00189618|Drug|Aspirin|100mg p.o. OD
16358919|NCT00189618|Drug|Clopidogrel|75mg p.o. OD
16358920|NCT00189605|Device|Perc-DLR/Perc-DLG|Device technique will be used per IFU
16358921|NCT00189605|Drug|Fluoroscopy guided transforaminal epidural steroid injection (TFESI)|Injection of steroid solution into the lumbar level
16358922|NCT00189592|Device|ArthroCare TOPAZ™ MicroDebrider™ using Coblation|Percutaneous treatment of plantar fascia using the Topaz device. No incision performed.
16358923|NCT00189592|Procedure|Surgical Fasciotomy|Standard surgical fasciotomy using an incision to treat the plantar fascia.
16358924|NCT00189579|Drug|Herceptin|
16358925|NCT00189566|Drug|Paclitaxel|
16358926|NCT00189566|Drug|Topotecan|
16358927|NCT00189566|Drug|Carboplatin|
16358928|NCT00189553|Drug|Pegylated liposomal doxorubicin|30 mg/m² every 4 weeks during 6 cycles or until progression
16358929|NCT00189553|Drug|Carboplatin|AUC 5 every 3/4 weeks during 6 cycles or until progression
16358930|NCT00189553|Drug|Paclitaxel|175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
16358933|NCT00189527|Procedure|respiratory settings|
16358934|NCT00189514|Drug|pramlintide acetate|Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
16358935|NCT00189514|Drug|placebo|subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
16358936|NCT00189501|Drug|Sensipar®|
16358937|NCT00189488|Drug|Palifermin|Administered as an intravenous (IV) bolus.
16358938|NCT00189488|Drug|Placebo|Administered as an intravenous (IV) bolus.
16358939|NCT00189488|Other|Conditioning Regimen|"Each participant received 1 of the following conditioning regimens:
~Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16)
~TBI/VP-16
~Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie > 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible)
~Busulfan (Bu)/Cy
~Bu/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2])
~Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2])"
16358940|NCT00189488|Procedure|Allogeneic stem cell transplant|Allogeneic marrow/peripheral blood progenitor cell transplantation
16358941|NCT00189488|Drug|Methotrexate|
16358942|NCT00189475|Drug|Montelukast|
16358943|NCT00189475|Drug|Placebo|
16358944|NCT00189462|Drug|Montelukast|
16358945|NCT00189462|Drug|Placebo|
16358946|NCT00189436|Drug|Nebulized Budesonide|Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
16358947|NCT00189436|Drug|Usual care (albuterol with or without oral steroid)|Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
16358948|NCT00189423|Device|Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)|"The ITD selectively prevents the influx of unnecessary respiratory gases into the patient during the chest wall recoil phase of CPR.
~The ResQPump, a hand-held device containing a suction cup, attaches to the chest and actively compresses and actively re-expands the chest during the performance of CPR."
16358949|NCT00189423|Procedure|Standard cardiopulmonary resuscitation (S-CPR)|Conventional standard cardiopulmonary resuscitation (S-CPR)
16358950|NCT00189410|Drug|Pegylated Liposomal Doxorubicin and Carboplatin|
16358951|NCT00189397|Drug|azathioprine and corticosteroids for Parthenium dermatitis|
16358952|NCT00189384|Drug|ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin|
16358953|NCT00189371|Drug|paclitaxel, carboplatin, epoetin alpha|
16358954|NCT00189358|Drug|ZD1839|
16358955|NCT00189358|Drug|tamoxifen|
16358956|NCT00189345|Biological|anti-EpCAM x anti-CD3 (removab)|
16358957|NCT00189332|Drug|852A|
16358958|NCT00189319|Drug|Flecainide controlled release|
16358959|NCT00189306|Drug|Imiquimod 5% cream|Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
16358960|NCT00189293|Drug|Imiquimod|"Imiquimod 5% cream three times per week for 4 weeks (1 sachet)
~1 or 2 sachet(s)"
16358961|NCT00189293|Other|vehicle cream|"vehicle cream three times per week for 4 weeks (1 sachet)
~1 or 2 sachet(s)"
16358962|NCT00189280|Drug|Imiquimod|cream 5%, 5 days out of seven, for 6 weeks
16358963|NCT00189267|Drug|Imiquimod 5 % Cream|
16358964|NCT00189254|Drug|Imiquimod|No defined treatments were given during this study.
16358965|NCT00189241|Drug|imiquimod|
16358966|NCT00189228|Drug|Xolair|Patients are administered Xolair
16358967|NCT00189215|Device|cardiac stabilizer instead of cardiopulmonary bypass|
16358968|NCT00189202|Drug|Sirolimus|Thymoglobulin induction, sirolimus and no maintenance corticosteroid
16358969|NCT00189189|Behavioral|parent management training|
16358970|NCT00189176|Drug|Tetrathiomolybdate|
16358971|NCT00189163|Drug|Pioglitazone|30 mg, taken orally, once per day, for 48 weeks
16358972|NCT00189163|Drug|Placebo Oral Tablet|Sugar Pill, taken orally, once per day, for 48 weeks
16358973|NCT00189150|Drug|Mycophenolate mofetil|
16358974|NCT00189150|Drug|Valganciclovir|
16358975|NCT00189137|Drug|ifosfamide and doxorubicin vs gemcitabine and docetaxel|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
~Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
16358976|NCT00189124|Drug|Dehydroepiandrosterone (DHEA)|
16358977|NCT00189111|Procedure|Cardiac Imaging + Treatment|
16358978|NCT00189098|Drug|Sulfamethoxazole-trimethoprim|18 mg/kg, two times a day
16358979|NCT00189098|Drug|Placebo|
16358980|NCT00189085|Drug|simvastatin and ezetimibe|
16358981|NCT00189072|Drug|gabapentin|
16358982|NCT00189059|Drug|amitriptyline|
16358983|NCT00189046|Behavioral|driving and laboratory tests|
16358984|NCT00189033|Drug|psyllium fibre (dietary supplement)|
16358985|NCT00189033|Drug|wheat bran (dietary supplement)|
16358986|NCT00189033|Drug|rice wheat (placebo)|
16358987|NCT00189020|Biological|PCV7|PCV7 at age 2 and 4 months
16358988|NCT00189020|Biological|PCV7|PCV7 at age 2, 4 and 11 months
16358989|NCT00189007|Drug|Allopurinol sodium|Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
16358990|NCT00189007|Drug|Mannitol|Mannitol 500 mg/50 mL water for injection, intravenously, single dose
16358991|NCT00188994|Drug|Insulin Cardioplegia|
16358992|NCT00188968|Procedure|Nasal Continuous Positive Airway Pressure|
16358993|NCT00188968|Procedure|Synchronized Nasal Positive Pressure Ventilation|
16358994|NCT00188955|Drug|sirolimus|
16358995|NCT00188942|Drug|Fluoxetine+Olanzapine|
16358996|NCT00188942|Drug|Olanzapine|
16358997|NCT00188942|Procedure|Functional Magnetic Resonance Imaging|
16358998|NCT00188929|Procedure|PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)|
16358999|NCT00188903|Procedure|Diastolic measurements during TEE|Transesophageal echocardiography with diastolic measurements
16359000|NCT00188877|Procedure|intensity modulated radiation therapy|
16359001|NCT00188877|Drug|cisplatinium and fluorouracil - standard treatment|
16359002|NCT00188864|Drug|dexamethasone|
16359003|NCT00188851|Drug|therapeutic management strategy|
16359004|NCT00188838|Behavioral|Psychoeduction|
16359005|NCT00188838|Behavioral|Cognitive-Behavioral Therapy|
16359009|NCT00188799|Procedure|daily Xray volume imaging for planning radiotherapy|
16359010|NCT00188786|Procedure|daily Cone Beam CT for imaging guidance for radiotherapy|
16359011|NCT00188773|Drug|N-acetylcysteine, intralipid, heparin|One visit subject will receive N-acetylcysteine plus intralipid and heparin, another visit n-acetylcyksteine plus saline, another visit intralipid and heparin and another visit saline alone
16359012|NCT00188747|Procedure|Thromboelastograph, Point of Care|
16359013|NCT00188708|Procedure|hypoxia measurement|transrectal oxygen measurement
16359014|NCT00188695|Procedure|MRI contrast agent Combidex (ferumoxtran-10)|Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.
16359015|NCT00188669|Drug|pentoxifylline|
16359016|NCT00188669|Drug|alpha-Tocopherol|
16359017|NCT00188656|Procedure|CT thorax|
16359018|NCT00188643|Drug|Venlafaxine and Lamotrigine|
16359019|NCT00188630|Drug|N-acetylcysteine|
16359020|NCT00188630|Other|5% dextrose solution|
16359021|NCT00188617|Drug|GEFITINIB|250 mg once a day for 28 days before surgery
16359022|NCT00188604|Drug|sodium selenite|
16359023|NCT00188578|Procedure|Intensity Modulated Radiation Therapy Boost|All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks
16359024|NCT00188565|Drug|Celecoxib|
16359025|NCT00188552|Drug|pentoxifylline|
16359026|NCT00188552|Drug|α-Tocopherol|
16359027|NCT00188539|Procedure|Pre-treatment tumour oxygen measurements (under anesthesia)|
16359028|NCT00188526|Device|lung biopsy|
16359029|NCT00188513|Procedure|conformal intensity modulated radiotherapy (IMRT)|
16359030|NCT00188500|Behavioral|atkins diet|
16359031|NCT00188500|Behavioral|ability to follow low carbohydrate diet|
16359032|NCT00188487|Device|magnetic resonance imaging (MRI) of the thorax|
16359033|NCT00188474|Behavioral|LCADLS, FACIT-PAL, FACIT-TS questionnaires|LCADLS, FACIT-PAL, FACIT-TS questionnaires
16359034|NCT00188461|Device|CT Thorax|
16359035|NCT00188448|Device|MRI|
16359036|NCT00188435|Procedure|Minimum Dose CT|
16359037|NCT00188422|Procedure|low dose CT|
16359038|NCT00188409|Procedure|CT scan|
16359039|NCT00188396|Drug|Citalopram|
16359040|NCT00188383|Drug|Amantadine|
16359041|NCT00188370|Procedure|high frequency ultrasound imaging|
16359042|NCT00188357|Behavioral|Education|
16359043|NCT00188344|Procedure|pneumatic dilatation|"The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic.
~The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours."
16359044|NCT00188344|Procedure|laparoscopic myotomy with partial fundoplication|The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.
16359045|NCT00188331|Behavioral|Neuropsychological Testing|neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
16359046|NCT00188318|Procedure|hyperfractionated accelerated radiotherapy|
16359047|NCT00188305|Behavioral|General health counselling and risk information|General health counselling and risk information
16359048|NCT00188279|Procedure|Minimum Dose Computed Tomography (MnDCT) scan|Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.
16359049|NCT00188266|Drug|cisplatinum combined with infusional fluorouracil (5 FU)|Continuous 5FU via intravenous PICC line + 4 doses of Cisplatin every 2 weeks
16359050|NCT00188240|Drug|Pegasys; Copegus.|
16359051|NCT00188227|Drug|Midazolam (sedative)|
16359052|NCT00188227|Drug|Piritramid (analgetic)|
16359053|NCT00188227|Behavioral|Cognitive exercises|
16359054|NCT00188214|Procedure|contrast-enhanced dynamic CT perfusion study|contrast-enhanced dynamic CT perfusion study pre treatment and post treatment
16359055|NCT00188188|Drug|quinipril|
16359056|NCT00188175|Radiation|Intensity Modulated Radiation Therapy|Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.
16359057|NCT00188162|Device|CT|
16359058|NCT00188149|Drug|Combined chemotherapy (ABVD, BACOPP-D)|
16359059|NCT00188149|Procedure|Radiation therapy|
16359060|NCT00188136|Drug|Melphalan, ATG, Fludarabine|allo Tx during aplasia
16359061|NCT00188110|Procedure|Water-Enema Computed Tomography|
16359062|NCT00188097|Behavioral|Diagnosis of variceal bleeding and dits control in cirrhosis|
16359063|NCT00188084|Procedure|DNA Index|
16359064|NCT00188084|Procedure|S-Phase%|
16359065|NCT00188084|Procedure|CD45 expression|
16359066|NCT00188084|Procedure|P16 metabolic way|
16359067|NCT00188071|Drug|paracetamol|
16359068|NCT00188071|Drug|ketoprofen|
16359069|NCT00188071|Drug|ketoprofen + paracetamol|
16359070|NCT00188058|Device|Setting of positive end-expiratory pressure|
16359071|NCT00188045|Drug|Propranolol - Spironolactone|
16359072|NCT00188032|Procedure|Computer-Assisted diagnostic Decision Support|
16359073|NCT00188032|Procedure|written diagnostic guidelines|
16359074|NCT00188032|Procedure|electronic therapeutic reminders|
16359075|NCT00188019|Procedure|diagnosis methods|
16359076|NCT00188006|Device|heparin-coated cardiopulmonary bypass|
16359077|NCT00187993|Drug|Growth hormone|
16359078|NCT00187967|Device|pumps used for cardiopulmonary bypass|
16359079|NCT00187941|Drug|Mycophenolate Mofetil|Targeted MPA exposure to 30-60 mg/L/h during the first month post-transplant.
16359080|NCT00187928|Drug|Topiramate|
16359261|NCT00186524|Behavioral|Breast Cancer Support Group|
16359081|NCT00187915|Drug|Mycophenolate mofetil + Tacrolimus|Target MPA exposure to 30-60 mg/L/h during first month post-transplant
16359082|NCT00187915|Drug|Mycophenolate mofetil + Cyclosporin|Target MPA exposure to 30-60 mg/L/h during first month post-transplant
16359083|NCT00187889|Drug|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
16359084|NCT00187889|Drug|Placebo or sugar pill|Placebo blinded as 25 mg tablet(1 pill) once daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
16359085|NCT00187876|Procedure|ACL reconstruction control|The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
16359086|NCT00187876|Procedure|ACL Biocleanse, surgical|The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
16359087|NCT00187863|Behavioral|pain perception|pain perception
16359088|NCT00187850|Procedure|PP|Partial pulpotomy
16359089|NCT00187850|Procedure|DPC|Direct pulp capping
16359090|NCT00187837|Procedure|SW|Stepwise removal of carious tissue in 2 stages
16359091|NCT00187837|Procedure|DCE|one complete excavation
16359092|NCT00187811|Procedure|Delta amino leavulinic acid photodynamic therapy|
16359093|NCT00187798|Drug|Metformin HCl|Subjects will be given a single oral dose in tablet form containing 850 mg of metformin
16359094|NCT00187785|Behavioral|Spanish speaker level|
16359095|NCT00187772|Behavioral|Child-Parent Psychotherapy (CPP)|
16359096|NCT00187759|Drug|cephalexin|
16359097|NCT00187746|Drug|Adefovir dipivoxil|Subjects will be given a single oral dose of 10 mg of adefovir dipivoxil
16359098|NCT00187733|Other|Fasting blood and urine collection|Not applicable no drugs dispensed
16359099|NCT00187720|Drug|Metformin|Subjects will be given a single oral dose of 850 mg of metformin
16359100|NCT00187707|Drug|Gabapentin|Subjects will take a single dose of 400 mg of gabapentin
16359101|NCT00187681|Drug|Metformin|2 doses of Metformin Day 1 1000mg, Day 2 850 mg
16359102|NCT00187655|Drug|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
16359103|NCT00187629|Behavioral|dietary phosphorus|varying amts dietary phosphorus
16359104|NCT00187603|Behavioral|tobacco cessation program|
16359105|NCT00187590|Behavioral|Case manager phone call after an ER visit|
16359106|NCT00187577|Drug|Latanoprost (Xalatan)|
16359107|NCT00187577|Drug|Bimatoprost (Lumigan)|Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.
16359108|NCT00187577|Drug|Topical application of latanoprost solution to eyelid|Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.
16359109|NCT00187564|Drug|controlled-release oral alpha-lipoic acid|
16359110|NCT00187551|Other|Interruption of enfuvirtide|treatment interruption
16359111|NCT00187551|Other|enfuvirtide interrupton|enfuvitide will be interrupted in patients harboring resistant virus
16359112|NCT00187538|Behavioral|Dietary|dietary
16359113|NCT00187525|Drug|Memantine|
16359114|NCT00187499|Drug|Inhaled fluticasone 500 ug BID for 8 weeks|
16359115|NCT00187486|Drug|Tarceva|Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status
16359116|NCT00187486|Drug|Temodar|Temodar 200 mg/m^2/day x 5 days every 28 days
16359117|NCT00187486|Procedure|Radiation Therapy|Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.
16359118|NCT00187473|Procedure|liver biopsy|Liver biopsy every 5 years
16359119|NCT00187460|Behavioral|Publicly released hospital cardiac report cards|Participating hospital corporations were randomized to either early feedback or delayed feedback (21 months later) in the form of publicly released hospital report cards of performance on a set of cardiac process-of-care quality indicators.
16359120|NCT00187447|Drug|indomethacin (two different dosing regimens)|
16359121|NCT00187434|Device|Infant Flow System|
16359122|NCT00187434|Device|Bubble CPAP|
16359123|NCT00187421|Procedure|Indocyanine green intraoperative angiogram and transit-time flowmetry|"ICG graft angiography following each distal anastomosis, and imaging of proximal anastomoses after all grafts completed.
~transit time flowmetry performed on all grafts after all grafts completed."
16359124|NCT00187408|Drug|Low Molecular Weight Heparin (dalteparin)|
16359125|NCT00187395|Procedure|Randomized to either a 'less tight' group or a 'tight' group|
16359126|NCT00187382|Drug|Multiple vs. single courses of antenatalcorticosteroids|
16359127|NCT00187369|Procedure|Method of Delivery|CS or VB
16359128|NCT00187356|Procedure|Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories|Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.
16359129|NCT00187343|Device|Breast IMRT|
16359130|NCT00187330|Drug|Intravenous N-acetylcysteine|
16359131|NCT00187317|Behavioral|Balance training (exercise)|Perturbation-based balance training. 30-minute sessions three times per week for six weeks.
16359132|NCT00187317|Other|Flexibility and relaxation exercise|30-minute sessions, three times per week for six weeks.
16359133|NCT00187304|Device|Aortic valve replacement|
16359134|NCT00187291|Device|T-Wave Alternans test|
16359135|NCT00187278|Device|Biventricular Pacing|Biventricular Pacemaker implant
16359136|NCT00187278|Device|RV Pacing|Standard Pacemaker implant
16359137|NCT00187265|Device|Cardiac Resynchronization Therapy|
16359138|NCT00187252|Device|Atrial Overdrive Pacing|Pacemaker/ ICD implant
16359319|NCT00185861|Drug|Arsenic Trioxide|
16359139|NCT00187239|Device|Autointrinsic Conduction Search Algorithm|Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
16359140|NCT00187226|Procedure|Radiation Therapy|External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
16359141|NCT00187226|Procedure|Radiation Therapy|External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
16359142|NCT00187213|Device|Cardiac Resynchronization Therapy|
16359143|NCT00187200|Device|Simultaneous VV Pacing|Right ventricular and left ventricular pacing delivered simultaneously.
16359144|NCT00187200|Device|Sequential VV Pacing|Right ventricular and left ventricular pacing delivered sequentially.
16359145|NCT00187187|Device|Implantable Defibrillator (ICD)|Implantable Defibrillator (ICD)
16359146|NCT00187187|Device|Implantable Defibrillator (ICD)|Implantable Defibrillator (ICD)
16359147|NCT00187174|Drug|Everolimus|The drug is given orally in 28 day courses.
16359148|NCT00187161|Drug|Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin|The additional information is contained in the Detailed Description section.
16359149|NCT00187148|Biological|EnvDNA|administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections
16359150|NCT00187135|Drug|Fentanyl|"Fentanyl - 1 mcg/kg in 3 ml normal saline
~Fentanyl - 0.5 mcg/kg in 3 ml normal saline"
16359151|NCT00187135|Drug|EMLA|All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours.
16359152|NCT00187135|Drug|L.M.X4|All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes.
16359153|NCT00187135|Drug|Propofol|Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.
16359154|NCT00187122|Drug|Vincristine|See Detailed Description section for description of treatment plan.
16359155|NCT00187122|Procedure|Radiation Therapy|See Detailed Description section for description of treatment plan.
16359156|NCT00187122|Drug|Daunomycin|See Detailed Description section for description of treatment plan.
16359157|NCT00187122|Drug|L-Asparaginase|See Detailed Description section for description of treatment plan.
16359158|NCT00187122|Drug|Cytarabine|See Detailed Description section for description of treatment plan.
16359159|NCT00187122|Drug|Methotrexate|See Detailed Description section for description of treatment plan.
16359160|NCT00187122|Drug|Mercaptopurine|See Detailed Description section for description of treatment plan.
16359161|NCT00187122|Drug|Etoposide|See Detailed Description section for description of treatment plan.
16359162|NCT00187122|Drug|Cyclophosphamide|See Detailed Description section for description of treatment plan.
16359163|NCT00187122|Drug|Prednisone|See Detailed Description section for description of treatment plan.
16359164|NCT00187122|Drug|Dexamethasone|See Detailed Description section for description of treatment plan.
16359165|NCT00187109|Drug|Recombinant Human Thrombopoietin|
16359166|NCT00187096|Drug|Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2|See Detailed Description section for additional details of treatment interventions.
16359167|NCT00187096|Procedure|Natural Killer Cell Infusion|See Detailed Description section for additional details of treatment interventions.
16359168|NCT00187096|Device|CliniMACS System|See Detailed Description section for additional details of treatment interventions.
16359169|NCT00187083|Drug|Topotecan, dexamethasone, vincristine|See Detailed Description section for details of treatment interventions.
16359170|NCT00187083|Drug|E. coli Asparaginase, PEG-L-asparaginase|See Detailed Description section for details of treatment interventions.
16359171|NCT00187083|Drug|erwinia asparaginase|See Detailed Description section for details of treatment interventions.
16359172|NCT00187083|Drug|fludarabine, methotrexate, mercaptopurine|See Detailed Description section for details of treatment interventions.
16359173|NCT00187083|Drug|idarubicin, etoposide, cytarbine, teniposide|See Detailed Description section for details of treatment interventions.
16359174|NCT00187083|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
16359175|NCT00187070|Drug|Doxorubicin, Cotrimoxazole, Carboplatin, Ifosfamide, Dexamethasone, Prednisone, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Vinblastine|See Detailed Description section for details of treatment interventions.
16359176|NCT00187070|Procedure|Stem cell transplant,|See Detailed Description section for details of treatment interventions.
16359177|NCT00187070|Radiation|Radiation Therapy|See Detailed Description section for details of treatment interventions.
16359178|NCT00187057|Drug|vinblastine, vincristine, prednisone, daunorubicin|See Detailed Description section for details of treatment interventions.
16359179|NCT00187057|Drug|doxorubicin, methotrexate, cyclophosphamide, L-asparaginase|See Detailed Description section for details of treatment interventions.
16359180|NCT00187057|Drug|etoposide, cytarabine, mercaptopurine|See Detailed Description section for details of treatment interventions.
16359181|NCT00187057|Drug|dexamethasone, procarbazine|See Detailed Description section for details of treatment interventions.
16359182|NCT00187057|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
16359183|NCT00187044|Biological|PolyEnv1 vaccine|administered subcutaneously as 10*7 pfu in 0.8 mL
16359184|NCT00187031|Drug|Topotecan, Filgrastim (G-CSF), Pegfilgrastim|See detailed description section for additional details.
16359185|NCT00187018|Biological|Bone marrow transplant|
16359186|NCT00187005|Drug|Prednisone, Dexamethasone, Vincristine, Daunorubicin, PEG-L-asparaginase|See Detailed Description section for details of treatment interventions.
16359187|NCT00187005|Drug|L-asparaginase, Methotrexate, Idarubicin, Etoposide, Cyclophosphamide, Cytarabine, Mercaptopurine|See Detailed Description section for details of treatment interventions.
16359507|NCT00184574|Drug|metformin|
16359188|NCT00186992|Radiation|image-guided radiotherapy|Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated.
16359189|NCT00186979|Drug|Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.|See Detailed Description section for details of treatment interventions.
16359190|NCT00186966|Drug|Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)|See Detailed Description section for details of treatment interventions.
16359191|NCT00186966|Drug|Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan|See Detailed Description section for details of treatment interventions.
16359192|NCT00186966|Procedure|Hematopoietic stem cell transplant|See Detailed Description section for details of treatment interventions.
16359193|NCT00186966|Radiation|Total body irradiation|See Detailed Description section for details of treatment interventions.
16359194|NCT00186953|Drug|Optison|"Intervention description:
~Based on recommendation by the FDA, we began with a dose of 0.125ml/m^2 and escalated at 0.15 ml/m^2 increments, to 0.275 ml/m^2 and 0.425ml/m^2 and 0.500ml/m^2. We will now continue to escalate the dose of Optison at 0.300ml/m^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer."
16359195|NCT00186940|Drug|Rasburicase|Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
16359196|NCT00186927|Biological|Sendai virus vaccine|Enders strain; a live, unmodified intranasally administered Sendai virus vaccine; given once in a dose escalation study, 5 x 10^5 to 5 x 10^7 EID(50) units.
16359197|NCT00186914|Biological|Marrow stromal cell infusion|"This is a pilot study of infusions of ex vivo expanded, gene marked donor bone marrow stromal cells following allogeneic bone marrow transplantation. The study is a within patient dose escalation safety evaluation. It is believed that this patient population may benefit from these donor stromal cell infusions.
~As the stromal cells will be obtained from the original stem cell donor, no conditioning is required.
~Patients will receive two infusions of mesenchymal cells (MSC) approximately 14 to 21 days apart unless there is unacceptable toxicity after the first infusion. The first dose of cells to be given will be 1x10^6 MSC/kg and the second dose of cells will be 5x10^6 MSC/kg. The patients will be followed for approximately 28 days following the second infusion for any toxicity. Only after all six patients have safely completed both infusions will we consider 5 x 10^6 MSC/kg a safe dose of allogeneic mesenchymal stem cells for infusion."
16359198|NCT00186901|Drug|Calcium carbonate (Tums), vitamin D|Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day
16359199|NCT00186901|Other|Placebo|Placebo
16359200|NCT00186888|Procedure|Enucleation|"Enucleation (possibly associated with all treatment strata/arms. For Stratum A, patients with bilateral disease will have surgery to remove the advanced eye before chemotherapy, or patients that have disease progression after chemotherapy may have surgery to remove the affected eye.
~For Stratum B, Surgical removal of the affected eye may be required in cases of disease progression For Stratum C, first intervention is removal of the affected eye."
16359201|NCT00186888|Drug|Vincristine, Carboplatin|(Stratum A subjects receive 8 courses every 3-4 weeks, Stratum B subjects receive this combination for Courses 3, 4, 6, 7, 9, and 10 after the window, if they respond to window therapy) Vincristine dosage< 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1.
16359202|NCT00186888|Procedure|Focal Therapies|Method will be at the discretion of the treating team, used after second course of chemotherapy. Cryotherapy- freezing of affected tissue, Laser photocoagulation- using lasers to destroy affected tissue, Thermotherapy and thermochemotherapy- using heat or heat/chemotherapy combination to destroy diseased tissue, and Episcleral plaque brachytherapy- radiation insertions in the diseased area to destroy affected tissue.
16359203|NCT00186888|Radiation|External Beam Radiation|44-46 Gy administered using standard practices , limiting dose to normal tissues to subjects with recurrent or progressive disease not considered controllable with focal treatments, Stratum B subjects with suspected active disease after completing therapy, or patients considered to have high-risk disease.
16359204|NCT00186888|Drug|Vincristine and Topotecan|(Stratum B subjects receive two up-front courses of vincristine and topotecan, given in 21-day intervals, then those who respond receive 3 additional courses (courses 5, 8, and 11) after the window. Dosages are the same for both window and subsequent courses: Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Topotecan: TSE of 140 ± 20 ng/ml*hr, daily for 5 consecutive days, infused over 30 minutes.
16359205|NCT00186888|Drug|Vincristine + Carboplatin + Etoposide|"Stratum B patients that do not respond to window receive 6 courses of this combination.
~Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1 Etoposide, < 12 months of age: 3.3 mg/kg/d i.v. days 1 - 3, ≥ 12 months of age: 100 mg/m2/d i.v. days 1 - 3"
16359206|NCT00186888|Drug|vincristine, cyclophosphamide, and doxorubicin|(High risk Stratum C patients in courses 2, 4, and 6 after enucleation, intermediate risk stratum C patients for four consecutive courses after enucleation) Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Cyclophosphamide: < 12 months of age: 40 mg/kg i.v. day 1, ≥ 12 months of age: 1,200 mg/m2 i.v. day 1, MESNA 200 mg/m2 at 0, 3, 6, and 9 hours Doxorubicin < 12 months of age: 1.5 mg/kg i.v. day 1, ≥ 12 months of age: 45 mg/m2 i.v. day 1
16359207|NCT00186888|Drug|Vincristine, Carboplatin and Etoposide|High risk Stratum C patients in courses 1, 3, and 5 after enucleation: Vincristine: < 12 months of age: 0.05 mg/kg i.v. day 1, ≥ 12 months of age: 1.5 mg/m2 i.v. day 1 (max. dose 2 mg) Carboplatin will be administered i.v. to achieve an AUC of 6.5 mg/ml/min, day 1 Etoposide, < 12 months of age: 3.3 mg/kg/d i.v. days 1 - 3, ≥ 12 months of age: 100 mg/m2/d i.v. days 1 - 3
16359208|NCT00186888|Procedure|Periocular carboplatin|Periocular (subtenon) carboplatin 20 mg, one injection, in courses 5, 8, and 11 in patients responding to the VT window, and in courses 1, 3, and 6 of VCE in patients not responding to the VT window, when active vitreous disease is present. Carboplatin 20 mg will be diluted in 2 mL of NS or D5W and given by subtenon administration while the patient is under general anesthesia.
16359209|NCT00186888|Other|G-CSF|G-CSF (5 mcg/kg/day), will be administered starting 24-36 hours after the completion of each course of chemotherapy, for 7 to 10 days, until ANC is > 2,000/mL in one occasion after the expected nadir.
16359210|NCT00186875|Drug|Etoposide, cytarabine, vincristine, dexamethasone|See Detailed Description section for details of treatment interventions.
16359211|NCT00186875|Drug|methotrexate, teniposide, PEG-asparaginase|See Detailed Description section for details of treatment interventions.
16359212|NCT00186875|Drug|mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine|See Detailed Description section for details of treatment interventions.
16359213|NCT00186875|Drug|L-asparaginase, erwinia asparaginase|See Detailed Description section for details of treatment interventions.
16359214|NCT00186875|Procedure|chemotherapy, intrathecal chemotherapy, steroid therapy|See Detailed Description section for details of treatment interventions.
16359215|NCT00186875|Procedure|Hematopoietic Stem Cell Transplant|See Detailed Description section for details of treatment interventions.
16359216|NCT00186875|Procedure|Natural Killer (NK) Cell Transplant|See Detailed Description section for details of treatment interventions.
16359217|NCT00186862|Drug|Interleukin-2|"A genetically modified (retroviral) allogeneic tumor vaccine coupled with the human interleukin-2. Patients were treated with 4 injections of these gene-modified tumor cells. The first two were given at weeks 1 and 2. Patients then had a 2 week rest and the remaining 2 injections were given at weeks 4 and 5. A complete evaluation for evidence of toxicity and response were performed at week 8.
~At this week 8 evaluation, if there was no excessive toxicity, progressive disease requiring therapy, and if more transduced cells are available, patients had the option to receive 4 additional injections. These additional injections were separated by 1 month at the higher of the two dosage levels originally received."
16359218|NCT00186849|Drug|Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin|See Detailed Description section for details of treatment interventions.
16359219|NCT00186849|Procedure|Peripheral Blood Stem Cell Transplant|See Detailed Description section for details of treatment interventions.
16359220|NCT00186836|Biological|Engerix-B and Twinrix|
16359221|NCT00186823|Device|Miltenyi Biotec CliniMACS|A stem cell selection device.
16359222|NCT00186823|Procedure|Stem Cell Transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
16359223|NCT00186823|Drug|TBI, systemic chemotherapy and antibodies as follows:|Transplant recipients received a myeloablative conditioning regimen consisting of total body irradiation, thiotepa, cyclophosphamide, ATG, and OKT3. Rituximab was provided prior to transplant for PTLPD prophylaxis. In addition to T cell depletion of the donor product, cyclosporine was administered for GVHD prophylaxis.
16359224|NCT00186810|Drug|Busulfan, Cyclophosphamide, Horse ATG|Transplant recipients received a myeloablative conditioning regimen of cyclophosphamide, Anti-Thymocyte Globulin (horse), and Busulfan. Cyclosporine and methotrexate were administered for GVHD prophylaxis.
16359225|NCT00186810|Procedure|Allogeneic stem cell transplant|Allogeneic stem cell transplant Matched sibling donor transplant Cord blood transplant
16359226|NCT00186797|Procedure|Allogeneic stem cell transplant|
16359227|NCT00186797|Drug|Fludarabine, Cyclophosphamide|
16359228|NCT00186784|Procedure|Transcranial Magnetic Stimulation (TMS)|treatment for 10 days
16359229|NCT00186771|Device|Paired Pulse|True treatment with rTMS over the temporoparietal cortex.
16359230|NCT00186771|Device|Paired Pulse|Sham treatment with rTMS over the temporoparietal cortex.
16359231|NCT00186758|Device|Transcranial Magnetic Stimulation (TMS)|"Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.
~Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -"
16359232|NCT00186745|Drug|Tinzaparin|Dose: 175 IU/kg subcutaneously once daily, up to 7 days. Dose reduction as per protocol if anti-Xa levels exceed pre-defined limits.
16359233|NCT00186732|Procedure|Subcuticular Suture|
16359234|NCT00186732|Procedure|Surgical Staples|
16359235|NCT00186706|Drug|Selenium|
16359236|NCT00186680|Procedure|high dose chemo then auto hematopoietic cell transplant|
16359237|NCT00186667|Procedure|high dose chemotherapy and autologous hematopoietic cell transplant|
16359238|NCT00186654|Procedure|Acupuncture|
16359239|NCT00186654|Procedure|Perinatal massage|
16359240|NCT00186641|Procedure|high dose chemo and auto hematopoietic cell transplant|
16359241|NCT00186628|Procedure|Total lymphoid irradiation|Total lymphoid irradiation (TLI) administered at 80cGy for 10 days
16359242|NCT00186628|Drug|Rituximab|Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.
16359243|NCT00186628|Drug|Anti-thymoglobulin, rabbit (ATG, rabbit ATG)|Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.
16359244|NCT00186628|Drug|Cyclosporine|Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates > 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).
16359245|NCT00186628|Drug|Mycophenylate mofetil|Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete
16359246|NCT00186628|Drug|Filgrastim|Filgrastim provided as needed for neutrophil support
16359247|NCT00186628|Drug|Granisetron|Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI
16359248|NCT00186628|Drug|Solumedrol|Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)
16359249|NCT00186628|Drug|Acetaminophen|Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC
16359250|NCT00186628|Drug|Diphenhydramine|Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC
16359251|NCT00186628|Drug|Hydrocortisone|Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC
16359252|NCT00186602|Behavioral|Peer counseling|
16359253|NCT00186589|Drug|90Y Ibritumomab tiuxetan|
16359254|NCT00186576|Procedure|nonmyeloablative allogeneic hematopoietic cell transplant|
16359255|NCT00186563|Procedure|Micro-plasmapheresis|
16359256|NCT00186550|Behavioral|Supportive Expressive Group Psychotherapy|
16359257|NCT00186550|Behavioral|Education|
16359262|NCT00186511|Behavioral|workbook/journal on coping with breast cancer|
16359263|NCT00186511|Behavioral|supportive expressive group therapy using videoconferencing|
16359264|NCT00186498|Drug|memantine|Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT
16359265|NCT00186498|Drug|Placebo Oral Capsule|Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
16359266|NCT00186485|Device|MagStim|The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain
16359267|NCT00186472|Behavioral|Brief Cognitive Behavioral Treatment|
16359268|NCT00186459|Behavioral|Hypocaloric diet of varying macronutrient composition|
16359269|NCT00186446|Drug|bupropion and smoking cessation behavioral intervention|
16359270|NCT00186420|Drug|Taxotere|
16359271|NCT00186407|Procedure|high dose chemo then auto hematopoietic cell transplant|
16359272|NCT00186394|Procedure|ablative allogeneic hematopoietic cell transplantation|
16359273|NCT00186381|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
16359274|NCT00186355|Procedure|high dose chemo then auto hematopoietic cell transplant|
16359275|NCT00186342|Procedure|ablative allogeneic hematopoietic cell transplantation|
16359276|NCT00186329|Drug|Natrecor, a recombinant form of B-type Natriuretic Peptide, made by Scios, Inc. vs. placebo|
16359277|NCT00186316|Biological|Idiotype-pulsed allogeneic dendritic cells|
16359278|NCT00186303|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
16359279|NCT00186303|Procedure|ablative allogeneic hematopoietic cell transplant|
16359280|NCT00186290|Procedure|ablative allogeneic hematopoietic cell transplantation|
16359281|NCT00186277|Drug|Oxaliplatin|Calculated per patient
16359282|NCT00186277|Drug|Taxotere|Calculated per patient
16359283|NCT00186264|Drug|venlafaxine XR|
16359284|NCT00186264|Drug|hydrocortisone|
16359285|NCT00186251|Procedure|high dose chemo then auto hematopoietic cell transplant|
16359286|NCT00186238|Procedure|high dose chemotherapy then autologous hematopoietic cell transplant|
16359287|NCT00186225|Procedure|ablative allogeneic hematopoietic cell transplantation|
16359288|NCT00186212|Behavioral|workbook/journal on coping with breast cancer|
16359289|NCT00186212|Behavioral|standard educational materials on breast cancer|
16359290|NCT00186186|Drug|Depakote ER|Depakote ER
16359291|NCT00186173|Behavioral|After school sports program|After school team sports intervention designed specifically for overweight and obese children
16359292|NCT00186173|Behavioral|After school health education|After school health and nutrition education program
16359293|NCT00186147|Procedure|collection and storage of tissue samples for research|Tissue samples include blood draws for the donor and recipient. A bone marrow sample may be obtained from the recipient. If the recipient undergoes a tissue biopsy for clinical reasons, a small fraction may be removed for research purposes. A small fraction of the donor graft may be removed at the time of collection for research.
16359294|NCT00186134|Behavioral|physical activity|
16359295|NCT00186121|Drug|Anastrozole (Arimidex)|Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone
16359296|NCT00186121|Drug|Goserelin (Zoladex)|Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
16359297|NCT00186108|Drug|Oral Triamcinalone|
16359298|NCT00186095|Procedure|autologous followed by nonmyeloablative allogeneic transplant|
16359299|NCT00186082|Drug|Cefotetan or Cefoxitin vs placebo|"Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously.
~Normal Saline, 100 ml intravenously for placebo arm."
16359300|NCT00186069|Drug|Magnesium Sulfate|Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.
16359301|NCT00186069|Other|Normal Saline|Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.
16359302|NCT00186056|Drug|Mifepristone|Glucocorticoid antagonist
16359303|NCT00186056|Drug|Placebo Oral Tablet|Inactive placebo tab
16359304|NCT00186043|Drug|Quetiapine/Seroquel|Quetiapine/Seroquel
16359305|NCT00186043|Drug|Placebo|Placebo
16359306|NCT00186030|Behavioral|HIV Skills-based Prevention|
16359307|NCT00186017|Drug|Olanzapine/Zyprexa|Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
16359308|NCT00186004|Device|Continuous Glucose Monitor|Subjects are fitted with a CGM system and perform self blood glucose measures three or more times per day for 3 days.
16359309|NCT00185991|Drug|gentamicin|"Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours).
~Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours)."
16359310|NCT00185978|Behavioral|diet, physical activity, reduced sedentary behavior|
16359311|NCT00185965|Drug|CPG 7909|6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
16359312|NCT00185952|Drug|Nifedipine|Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
16359313|NCT00185939|Drug|Augmentin|
16359314|NCT00185900|Drug|Magnesium Sulfate|Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
16359315|NCT00185900|Drug|Nifedipine|Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
16359316|NCT00185887|Drug|Terbutaline|Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.
16359317|NCT00185874|Biological|Intratumoral Dendritic Cell Immunotherapy|
16359318|NCT00185874|Biological|autologous dendritic cells|
16359320|NCT00185861|Procedure|Stereotactic radiosurgery|
16359321|NCT00185848|Radiation|[18F]FHBG|< 7mCi and 2 ug, iv
16359322|NCT00185835|Drug|ZD-1839|
16359323|NCT00185835|Drug|Cisplatin|
16359324|NCT00185796|Procedure|Total Lymphoid Irradiation (TLI)|TLI is administered ten times in 120cGy fractions on day -11 through day -7 and day -4 through day -1
16359325|NCT00185796|Procedure|Anti-Thymocyte Globulin as Conditioning (ATG)|Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg. Thymoglobulin doses will be based on the adjusted ideal body weight if the patient is greater than or equal to 15 kg over ideal body weight.
16359326|NCT00185783|Drug|Hydrocortisone Administration (Standard of Care Therapy)|
16359327|NCT00185770|Behavioral|Reducing television and other screen time (SMART curriculum)|
16359328|NCT00185757|Drug|Cytokine Induced Killer Cells|CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients
16359329|NCT00185744|Radiation|Intra-Operative Radiotherapy (IORT)|single dose in the operating room after lumpectomy
16359330|NCT00185744|Procedure|Lumpectomy|
16359331|NCT00185744|Radiation|Whole Breast Radiotherapy|six and a half week treatment
16359332|NCT00185744|Radiation|Intracavitary Brachytherapy|5 day treatment
16359333|NCT00185744|Radiation|Accelerated External Beam 3-D Conformal Radiotherapy|5 day treatment
16359334|NCT00185744|Radiation|Stereotactic APBI|4 day treatment
16359335|NCT00185731|Drug|Atorvastatin|80 mg orally once daily
16359336|NCT00185705|Drug|Telmisartan|
16359337|NCT00185692|Procedure|non-myeloablative hematopoietic cell transplantation|TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
16359338|NCT00185692|Drug|Anti-Thymocyte Globulin|1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
16359339|NCT00185692|Drug|Cyclosporine|6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
16359340|NCT00185692|Drug|Mycophenolate Mofetil|15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
16359341|NCT00185692|Drug|G-CSF|16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
16359342|NCT00185692|Drug|Solumedrol|1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
16359343|NCT00185692|Drug|Acetaminophen|650 mg PO, 30 minutes prior to infusion Pain reliever
16359344|NCT00185692|Drug|Diphenydramine|50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
16359345|NCT00185692|Drug|Hydrocortisone|100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
16359346|NCT00185679|Device|CliniMACS System|"The CliniMACS System is a cell selection device consisting of the following components:
~Computer-controlled instrument;
~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
~Wash buffer"
16359347|NCT00185666|Procedure|Stereotactic radiosurgery|
16359348|NCT00185653|Procedure|Autologous followed by non-myeloablative allogeneic transplantation|
16359349|NCT00185640|Drug|Cyclosporine|Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL
16359350|NCT00185640|Drug|Anti-thymocyte globulin (ATG)|1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT
16359351|NCT00185640|Drug|Mycophenolate mofetil (MMF)|Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.
16359352|NCT00185640|Drug|Filgrastim|"Donors mobilized with 16 µg/kg/day filgrastim.
~As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day"
16359353|NCT00185640|Radiation|Total Lymphoid Irradiation (TLI)|0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.
16359354|NCT00185614|Procedure|Autologous hematopoietic cell transplant (Auto-HCT)|The target cell dose is 2.6 x 10e6 CD34+ cells/kg
16359355|NCT00185614|Procedure|Allogeneic hematopoietic cell transplant (Allo-HCT)|The target cell dose is 5 x 10e6 CD34 cells/kg
16359356|NCT00185614|Drug|Cyclophosphamide|Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
16359357|NCT00185614|Drug|Filgrastim|"Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT)
~Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT)
~Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)"
16359358|NCT00185614|Drug|Melphalan|Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
16359359|NCT00185614|Radiation|Total body irradiation (TBI)|200 centigray (cGy) total body irradiation delivered on Day 0
16359360|NCT00185614|Procedure|Cyclosporine (CSP)|Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
16359361|NCT00185614|Drug|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
16359362|NCT00185601|Behavioral|Internet Diabetes Self-Management Program|
16359363|NCT00185588|Drug|Vatalanib|Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours
16359364|NCT00185588|Drug|Gemcitabine|850 mg/m2
16359365|NCT00185575|Drug|duloxetine|
16359366|NCT00185562|Drug|Adalimumab|
16359367|NCT00185549|Behavioral|CF. DOC|
16367989|NCT00111930|Drug|DHEA|
16359368|NCT00185536|Behavioral|Packaging and identification of source|
16359369|NCT00185523|Procedure|Allogeneic hematopoietic cell transplantation|
16359370|NCT00185510|Drug|Methylprednisolone Aceponate (Advantan, BAY86-4862)|In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
16359371|NCT00185510|Drug|Placebo|2 days a week Vehicle (Advabase)
16359372|NCT00185484|Drug|YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)|Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles
16359373|NCT00185458|Drug|LNG IUS|LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
16359374|NCT00185445|Drug|Fludarabine Phosphate (Fludara)|All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals.
16359375|NCT00185419|Drug|Yasmin|30 µg ethinylestradiol, 3mg drospirenone
16359376|NCT00185419|Drug|Marvelon|30 µg ethinylestradiol, 150 µg desogestrel
16359377|NCT00185393|Biological|Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)|treatment with 90 Yttrium-labeled anti CD 20 antibody
16359378|NCT00185393|Other|no treatment|no treatment
16359379|NCT00185380|Drug|Levonorgestrel IUS (BAY86-5028, G04209B)|Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
16359380|NCT00185380|Drug|Levonorgestrel IUS (BAY86-5028, G04209C)|Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
16359381|NCT00185380|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
16359382|NCT00185367|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo
16359383|NCT00185367|Drug|SH D 593 B (Miranova)|7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo
16359384|NCT00185354|Drug|BAY86-5016, SH P00331F|Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)
16359385|NCT00185354|Drug|SH P00331N|Drug amount per patch: 0.6 mg EE2 + 6 mg NGM
16359386|NCT00185341|Drug|CCR1-Antagonist (BAY86-5047, ZK811752)|Given orally in a dose of 600 mg three times daily over 12 weeks
16359387|NCT00185341|Drug|Placebo|Placebo
16359388|NCT00185328|Drug|Estradiol/DRSP (Angeliq, BAY86-4891)|1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles
16359389|NCT00185315|Drug|Ventavis (Iloprost, BAYQ6256)|Inhaled iloprost
16359390|NCT00185302|Drug|Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)|MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
16359391|NCT00185302|Drug|Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)|MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle
16359392|NCT00185289|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
16359393|NCT00185276|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
16359394|NCT00185276|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight
16359395|NCT00185263|Genetic|AdF5FGF-4 vs. Placebo|Intracoronary infusion
16359396|NCT00185250|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
16359397|NCT00185250|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day
16359398|NCT00185250|Drug|Placebo|0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
16359399|NCT00185250|Drug|Placebo|0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
16359400|NCT00185237|Drug|Menostar (estradiol transdermal delivery system)|Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
16359401|NCT00185237|Drug|Placebo|Placebo patch
16359402|NCT00185224|Drug|EV/DNG (Qlaira, BAY86-5027, SH T00658K)|7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo
16359403|NCT00185224|Drug|SH D00264A (Triquilar)|7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo
16359404|NCT00185211|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
16359405|NCT00185211|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
16359406|NCT00185198|Drug|Testogel (Testosterone, BAYV001915)|50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months
16359407|NCT00185198|Drug|Placebo|5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1
16368161|NCT00110500|Genetic|hVEGF-A|
16359408|NCT00185185|Drug|Olmesartan medoxomil|
16359409|NCT00185185|Drug|Atenolol|
16359410|NCT00185185|Drug|Hydrochlorothiazide|tablets
16359411|NCT00185185|Drug|olmesartan medoxomil|tablets
16359412|NCT00185185|Drug|atenolol|tablets
16359413|NCT00185172|Other|placebo|Placebo oral tablets for 2 weeks
16359414|NCT00185172|Drug|olmesartan medoxomil|olmesartan medoxomil oral tablets for 8 weeks
16359415|NCT00185172|Drug|olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets|olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
16359416|NCT00185159|Drug|Olmesartan medoxomil|tablets
16359417|NCT00185159|Drug|Placebo Tablets|Tablets
16359418|NCT00185146|Drug|Pactimibe|
16359419|NCT00185133|Drug|Olmesartan medoxomil|
16359420|NCT00185133|Drug|Amlodipine|
16359421|NCT00185120|Drug|Olmesartan medoxomil|
16359422|NCT00185120|Drug|Hydroclorothiazide|
16359423|NCT00185120|Drug|Benazepril|
16359424|NCT00185120|Drug|Amlodipine|
16359425|NCT00185107|Drug|Colesevelam Hydrochloride|
16359426|NCT00185107|Drug|Ezetimibe|
16359427|NCT00185107|Drug|Simvastatin|
16359428|NCT00185094|Drug|Olmesartan medoxomil|
16359429|NCT00185094|Drug|Losartan potassium|
16359430|NCT00185094|Drug|Atenolol|
16359431|NCT00185081|Drug|Indium labeled IMP-205xm734|
16359432|NCT00185068|Drug|Olmesartan medoxomil|
16359433|NCT00185068|Drug|Olmesartan medoxomil/hydrochlorothiazide|
16359434|NCT00185068|Drug|Hydrochlorothiazide|
16359435|NCT00185055|Drug|Olmesartan medoxomil|
16359436|NCT00185055|Drug|Irbesartan|
16359437|NCT00185055|Drug|Valsartan|
16359438|NCT00185042|Drug|Pactimibe, CS-505|
16359439|NCT00185029|Procedure|Ferumoxtran-10 enhanced MRI (MRL)|
16359440|NCT00185016|Behavioral|a training to improve recognition of partner abuse.|
16359441|NCT00185003|Drug|endotoxin|
16359442|NCT00185003|Drug|Potassium channel blockers: TEA, Quinin, Tolbutamide|
16359443|NCT00185003|Drug|L-NMMA|
16359444|NCT00184990|Drug|Aminoguanidine|
16359445|NCT00184990|Drug|endotoxin|
16359446|NCT00184977|Drug|N-acetylcysteine|
16359447|NCT00184977|Drug|fluticasone propionate|
16359448|NCT00184964|Procedure|CT-scan, PET-scan|
16359449|NCT00184951|Drug|Rosuvastatin|
16359450|NCT00184938|Drug|morphine|
16359451|NCT00184938|Drug|naloxone|
16359452|NCT00184938|Drug|Technetium-TC99m-labeled Annexin A5|
16359453|NCT00184938|Procedure|forearm ischemic exercise|
16359454|NCT00184938|Procedure|ten minute forearm ischemia|
16359455|NCT00184925|Procedure|Tracheostomy|trachesotomy with subglottic drainage
16359456|NCT00184925|Device|cannula with subglottic drainage|
16359457|NCT00184912|Drug|caffeine|
16359458|NCT00184912|Drug|Technetium-TC99m-labeled Annexin A5|
16359459|NCT00184912|Procedure|ten minutes forearm ischemia|
16359460|NCT00184912|Procedure|ischemic forearm exercise|
16359461|NCT00184899|Drug|Intravenous infusion of Intralipid/heparin|
16359462|NCT00184899|Drug|Intravenous infusion of Glycerol/heparin|
16359463|NCT00184886|Drug|Methotrexate 15 mg/week for 12 weeks|
16359464|NCT00184873|Behavioral|Health Counseling|
16359465|NCT00184860|Procedure|PET-scan, MRI-scan|
16359466|NCT00184847|Drug|acetylcholine|
16359467|NCT00184847|Procedure|twenty minutes of forearm ischemia|
16359468|NCT00184847|Procedure|three 5-minute periods of forearm ischemia|
16359469|NCT00184847|Drug|adenosine|
16359470|NCT00184847|Drug|caffeine|
16359471|NCT00184834|Behavioral|quality of life|
16359472|NCT00184821|Procedure|Ischemic preconditioning|
16359473|NCT00184821|Procedure|Forearm ischemic exercise|
16359474|NCT00184821|Procedure|Annexin A5 scintigraphy|
16359475|NCT00184821|Drug|Diazoxide|
16359476|NCT00184821|Drug|glibenclamide|
16359477|NCT00184821|Drug|adenosine|
16359478|NCT00184795|Drug|0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)|One tablet per day for 24 weeks
16359479|NCT00184795|Drug|0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)|One tablet per day for 24 weeks
16359480|NCT00184795|Drug|placebo|Placebo tablets for 24 weeks
16359481|NCT00184782|Procedure|FDG-PET|
16359482|NCT00184769|Drug|somatropin|
16359483|NCT00184756|Drug|somatropin|
16359484|NCT00184743|Drug|somatropin|
16359485|NCT00184730|Drug|somatropin|
16359486|NCT00184717|Drug|somatropin|0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
16359487|NCT00184717|Drug|somatropin|0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
16359488|NCT00184691|Drug|somatropin|
16359489|NCT00184678|Drug|somatropin|
16359490|NCT00184665|Drug|insulin detemir|
16359491|NCT00184665|Drug|insulin NPH|
16359492|NCT00184665|Drug|insulin aspart|
16359493|NCT00184652|Drug|somatropin|
16359494|NCT00184639|Drug|insulin detemir|
16359495|NCT00184626|Drug|biphasic insulin aspart|
16359496|NCT00184626|Drug|insulin glargine|
16359497|NCT00184626|Drug|metformin|
16359498|NCT00184613|Device|pump|
16359499|NCT00184613|Drug|insulin glargine|
16359500|NCT00184613|Drug|insulin aspart|
16359501|NCT00184600|Drug|biphasic insulin aspart|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
16359502|NCT00184600|Drug|insulin detemir|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
16359503|NCT00184600|Drug|insulin aspart|Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
16359504|NCT00184587|Drug|candesartan cilexetil|
16359505|NCT00184587|Drug|placebo|
16359506|NCT00184574|Drug|biphasic insulin aspart|
16359508|NCT00184561|Drug|biphasic insulin aspart|
16359509|NCT00184548|Drug|eptacog alfa (activated)|"Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.
~Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours."
16359510|NCT00184548|Drug|placebo|placebo
16359511|NCT00184522|Drug|Aflurax|
16359512|NCT00184522|Drug|esomeprazole|
16359513|NCT00184509|Behavioral|integrated psychosocial treatment (behavior)|
16359514|NCT00184496|Drug|Methadone|To methods for switching morphine to methadon. Stop-and go versus overlap
16359515|NCT00184483|Procedure|Lichtenstein's operation|Lichtenstein's operation to repair primary unilateral inguinal hernia
16359516|NCT00184483|Procedure|Prolene Hernia System|Prolene Hernia System to repair primary unilateral inguinal hernia
16359517|NCT00184457|Behavioral|Strength training intervention|
16359518|NCT00184444|Behavioral|Hypoxic interval training|4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max
16359519|NCT00184444|Behavioral|Normoxic interval training|4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max
16359520|NCT00184431|Behavioral|Physical therapy technique and exercises|The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.
16359521|NCT00184392|Procedure|debridement or saline irrigation|debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery
16359522|NCT00184379|Behavioral|Psychoeducation|Structured disorder-related educational program for relatives
16359523|NCT00184366|Drug|efalizumab|efalizumab
16359524|NCT00184340|Device|eTherapy|secured e-mail system between patient and therapist
16359525|NCT00184327|Behavioral|Intensive family therapy - inpatient|2-4 weeks (5days) family inpatient assessment and treatment
16359526|NCT00184327|Behavioral|Diagnostic assessment - child and adolescent psychiatry|
16359527|NCT00184301|Behavioral|inpatient treatment|inpatient treatment during 1 year
16359528|NCT00184301|Behavioral|outpatient treatment|intensive outpatient treatment consisting of two-weekly group sessions during 1 year
16359529|NCT00184262|Behavioral|ERP cognitive therapy|15 exposure and response prevention (ERP) sessions in 3 months with a cognitive therapy rationale
16359530|NCT00184262|Behavioral|ERP behavioral therapy|15 exposure and response prevention (ERP) sessions in 3 months with a behavioral therapy rationale
16359531|NCT00184249|Procedure|Bipolar radiofrequency ablation|Ablation using CE marked bipolar ablation devices
16359532|NCT00184236|Behavioral|Multitreatment approach|12 months regimen consisting of group meetings every 2 weeks involving a physician, psychologist, physiotherapist and clinical nutritional physiologist. 21 h treatment during the first 3 months: 3 activity sessions (3 h) and 3 group conversations (4 h). Attendance inclusion criterium was set to minimum of 80%
16359533|NCT00184236|Behavioral|Aerobic interval training|Walking/running 'uphill' on a treadmill twice a week for 3 months. 10 min warming-up at 70% of Hfmax before performing 4x4 intervals at 90-95% of Hfmax. 3 min active recovery at 70% of Hfmax between each interval. 5 min cool-down period, giving a total of 40 min.
16359534|NCT00184223|Behavioral|Motivational Interviewing|2 sessions of 45 minutes each with manual guided motivational interviewing delivered individually by a trained therapist.
16359535|NCT00184223|Other|Treatment as usual|Treatment as usual is individualized according to the clinical condition of the patients during the stay and in accordance with general national and international medical standards. It includes detoxification, pharmacotherapy, and general psychotherapy. Also, treatment is given for any coexisting non-substance-related disorder, including psychiatric disorders.
16359536|NCT00184197|Drug|Botulinum toxin|
16359537|NCT00184197|Drug|Placebos|
16359538|NCT00184171|Drug|Budesonide|Budesonide 9 mg
16359539|NCT00184171|Drug|Bismuth|Bismuth mixture
16359540|NCT00184171|Drug|Fiber|Fiber for control
16359541|NCT00184158|Procedure|decompression|Conservative, simple decompression and nerve transfer
16359542|NCT00184145|Other|EMDR (Eye Movement Desensitization and Reprocessing)|Psychotherapy which is approved for PTSD.
16359543|NCT00184145|Other|Exposure therapy|All participants in the study received exposure therapy som second treatment. Exposure therapy is the therapy of choice for animal phobia.
16359544|NCT00184132|Procedure|Psychiatric intensive care unit in Norwegian home style|
16359545|NCT00184132|Procedure|Psychiatric intensive care unit sparsely furnished and not decorated|
16359546|NCT00184119|Procedure|Psychiatric Intensive Care Unit|
16359547|NCT00184119|Procedure|Care in whole acute unit|psychiatric acute care as usual
16359548|NCT00184106|Drug|Seroxat, Cognitive therapy, Seroxat+ cognitive therapy|Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
16359549|NCT00184093|Drug|Gemcitabine|Gemcitabine weekly x 6 wks with concurrent external radiation
16359550|NCT00184080|Drug|Elsamitrusin|
16359551|NCT00184067|Biological|Montanide ISA 51|
16359552|NCT00184054|Drug|Arsenic Trioxide (ATO)|Arsenic Trioxide .25 mg/kg/day
16359553|NCT00184054|Drug|Ascorbic Acid|Ascorbic Acid 1000 mg every other day for 25 days
16359554|NCT00184041|Drug|Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine|Induction I/II, consolidation I/II/III/IV and Maintenance
16359555|NCT00184028|Drug|Taxotere|Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
16359556|NCT00184028|Drug|Oxaliplatin|Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
16359557|NCT00184015|Drug|Bevacizumab and Bortezomib|Bevacizumab 15 mg/kg on day 1 with Bortezomib 1.0 or 1.3 mg/m2 on days 1, 4, 8 and 11 every 21 days
16359558|NCT00184015|Drug|Bevacizumab and Bortezomib|Bevacizumab 15 mg/kg on day 1 with Bortezomib 1.6 or 1.8 mg/m2 on days 1 and 8 every 21 days
16359612|NCT00183573|Behavioral|Intensive Informational Intervention|4-hour, information-only intensive group workshop
16359739|NCT00182650|Biological|therapeutic autologous lymphocytes|
16359559|NCT00184002|Drug|Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone|"Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
~Prednisone 100 mg po days 1-5.
~Cycle 2 until study completion
~Doxil 40 mg/m2 iv day 1
~Rituxan 375 mg/m2 iv day 1
~Cyclophosphamide 750 mg/m2 iv day 1
~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum)
~Prednisone 100 mg po days 1-5
~1 cycle = 21 days.
~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles."
16359560|NCT00183989|Drug|Fludarabine, Mitoxantrone and Rituximab|
16359561|NCT00183976|Drug|Pegylated Liposomal Doxorubicin (Doxil) and Rituximab|
16359562|NCT00183963|Drug|Tamoxifen|20mg
16359563|NCT00183963|Drug|Fulvestrant|250mg
16359564|NCT00183963|Drug|Fulvestrant|500 mg IM
16359565|NCT00183950|Drug|Noscapine|
16359566|NCT00183937|Drug|PS 341|PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
16359567|NCT00183937|Drug|Docetaxel|Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
16359568|NCT00183924|Drug|Estramustine|
16359569|NCT00183924|Drug|Docetaxel|
16359570|NCT00183924|Drug|Carboplatin|
16359571|NCT00183911|Drug|floxuridine, 5-Fluorouracil, leucovorin|
16359572|NCT00183911|Procedure|External Beam Radiotherapy|
16359573|NCT00183911|Procedure|Surgery|
16359574|NCT00183898|Drug|oxaliplatin, capecitabine|cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
16359575|NCT00183885|Drug|mitomycin-c, cisplatin|Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
16359576|NCT00183872|Drug|irinotecan, docetaxel|docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
16359577|NCT00183859|Drug|irinotecan|Intraperitoneal Irinotecan given every three weeks
16359578|NCT00183846|Drug|irinotecan|
16359579|NCT00183846|Procedure|radiation therapy|
16359580|NCT00183833|Drug|capecitabine, imatinib mesylate|Capecitabine and imatinib mesylate will both be taken by mouth twice a day
16359581|NCT00183820|Drug|paclitaxel, gemcitabine, and oxaliplatin|"Paclitaxel 170 mg/m2 IV d 1 14 days
~Gemcitabine 800 mg/m2 IV d 1 14 days
~Oxaliplatin 100 mg/m2 IV d 1 14 days"
16359582|NCT00183807|Drug|irinotecan, cisplatin, celecoxib|
16359583|NCT00183794|Drug|Docetaxel and Gemcitabine|Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.
16359584|NCT00183781|Behavioral|FITT: Family Intervention - Telephone Tracking|
16359585|NCT00183768|Behavioral|Cognitive Behavioral Therapy|
16359586|NCT00183768|Behavioral|Psychopharmacology|
16359587|NCT00183742|Drug|liposomal doxorubicin and docetaxel|
16359588|NCT00183729|Drug|Memantine|Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
16359589|NCT00183729|Other|Placebo|Placebo distribution is planned to mimic the active drug.
16359590|NCT00183716|Behavioral|Trauma Recovery and Empowerment Model (TREM)|TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment.
16359591|NCT00183716|Behavioral|Usual care|Participants will receive usual care for women who have experienced psychological trauma.
16359592|NCT00183690|Procedure|Prolonged Exposure Therapy|Prolonged exposure therapy includes a trauma focused protocol and cognitive behavioral treatment for PTSD. Cognitive behavioral treatment includes psychoeducation, in vivo exposures, and imaginal exposures.
16359593|NCT00183690|Procedure|Active Psychotherapy|Active psychotherapy includes non-trauma focused therapy, based on time-limited psychodynamic treatment, which includes a formulation of a central issue and open-associative sessions exploring main conflicts and drives.
16359594|NCT00183677|Drug|Escitalopram|Escitalopram 10 to 30 mg per day for 12 weeks
16359595|NCT00183651|Behavioral|Standard dialectical behavior therapy (SDBT)|Standard DBT includes: 1) individual DBT therapy (1 hour per week), 2) DBT group skills training (2.5 hours per week), 3) telephone consultation (as needed), and 4) therapist consultation team (1 hour per week).
16359596|NCT00183651|Behavioral|Individual DBT with no DBT group sessions (DBT-I)|Individual DBT (DBT-I) is 1 hour per week of individual therapy and 2.5 hours per week with the psychosocial activities group.
16359597|NCT00183651|Behavioral|Group Skills DBT with no DBT individual sessions (DBT-S)|DBT group skills training is 2.5 hours per week and includes individual case management.
16359598|NCT00183638|Behavioral|Internet-based tailored prevention messages|Participants will receive five 30-second flash clips promoting condom norms, positive attitudes, self-efficacy, and risk awareness. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage.
16359599|NCT00183638|Behavioral|Non-tailored messages|The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.
16359600|NCT00183625|Behavioral|Individual Placement and Support (Supported Employment)|
16359601|NCT00183625|Behavioral|Social Skills Training|
16359602|NCT00183625|Drug|Olanzapine|
16359603|NCT00183625|Drug|Risperidone|
16359604|NCT00183612|Drug|Olanzapine|
16359605|NCT00183599|Behavioral|5 Minutes of Simple Advice|
16359606|NCT00183599|Behavioral|Motivational Enhancement Therapy (MET)|
16359607|NCT00183599|Behavioral|Cognitive Behavioral Therapy (CBT)|
16359608|NCT00183586|Behavioral|Family therapy (FT)|FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.
16359609|NCT00183586|Behavioral|Individual therapy (IT)|IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.
16359610|NCT00183573|Behavioral|Brief Motivational Intervention|15-20 minute, motivational one-on-one counseling
16359611|NCT00183573|Behavioral|Brief Informational Intervention|15 minute informational DVD on safer sex
16359613|NCT00183573|Behavioral|Intensive Info-Motivation-Behavioral Skills Intervention|4-hour, intensive group workshop with emphasis on motivation and skills
16359614|NCT00183560|Behavioral|Mindfulness based cognitive therapy (MBCT)|Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
16359615|NCT00183560|Drug|Antidepressants|Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
16359616|NCT00183560|Drug|Placebo plus clinical management|Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
16359617|NCT00183547|Behavioral|"Living in Harmony depression prevention program"|Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
16359618|NCT00183547|Behavioral|Depression-prevention education and support|Weekly therapy sessions offering general depression-prevention education and support
16359619|NCT00183521|Behavioral|Raise-CO2 breathing regulation training|Reverse hyperventilation (defined by low arterial CO2) is often characteristic of individuals with panic disorder. Participants will be randomly assigned to one of three groups: raise-CO2 breathing, lower-CO2 breathing, or a control group. Participants in the raise-CO2 group will be taught techniques to recover from hyperventilation faster.
16359620|NCT00183521|Behavioral|Lower-CO2 breathing regulation training|According to the false suffocation alarm theory, anxiety is experienced when an overly sensitive hypothalamic mechanism is triggered by rising pCO2. Participants in the lower-CO2 group will be taught techniques to reach hyperventilation levels, then switch to breathing techniques that reduce hyperventilation symptoms.
16359621|NCT00183521|Behavioral|Control|Participants in the control group will not be taught any breathing techniques but will be included in all assessments.
16359622|NCT00183508|Behavioral|Cognitive behavioral therapy|Participants will learn cognitive behavioral strategies for symptom reduction
16359623|NCT00183508|Behavioral|Psychoeducation|Participants will receive psychoeducation regarding common reactions to traumatic events
16359624|NCT00183482|Behavioral|Family Group Cognitive Behavioral|Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
16359625|NCT00183482|Behavioral|Written Information|Families are mailed written materials that describe depression and stress in families with a depressed parent.
16359626|NCT00183469|Drug|Lamotrigine|If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.
16359627|NCT00183469|Drug|Divalproex (DIV) ER|If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.
16359628|NCT00183469|Drug|Placebo|During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.
16359629|NCT00183456|Behavioral|Peer-oriented intervention|The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.
16359630|NCT00183456|Behavioral|Group cognitive behavioral therapy (CBT)|Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
16359631|NCT00183443|Drug|Divalproex-extended release (DVP-ER)|Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
16359632|NCT00183443|Drug|Lithium|Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
16359633|NCT00183443|Drug|Quetiapine|Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
16359634|NCT00183430|Drug|Prazosin|Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
16359635|NCT00183430|Drug|Placebo|Placebo capsules are taken orally twice per day at 10 am and bedtime.
16359636|NCT00183430|Behavioral|Psychotherapy|All participants will undergo psychotherapy during medication treatment period.
16359637|NCT00183417|Behavioral|Cognitive behavior therapy (CBT)|Participants will complete worksheets and group discussion on how to increase positive mood and activity.
16359638|NCT00183417|Behavioral|Supportive/expressive (S/E) therapy|Participants will be encouraged to express feelings and emotions without advice giving.
16359639|NCT00183417|Behavioral|Bibliotherapy|Participants will be given a book on how to increase their mood.
16359640|NCT00183404|Drug|Olanzapine|Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
16359641|NCT00183391|Drug|Atomoxetine|Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
16359642|NCT00183391|Drug|Methylphenidate|Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
16359643|NCT00183378|Behavioral|Walking Program|The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
16359644|NCT00183378|Behavioral|Light Exposure Program|The therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.
16359736|NCT00182663|Drug|dexamethasone|Given PO
16359737|NCT00182650|Biological|aldesleukin|
16359645|NCT00183378|Behavioral|Combined Education, Walking and Light Exposure Program|The therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
16359646|NCT00183378|Behavioral|Routine Medical Care with Education|The therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation.
16359647|NCT00183365|Behavioral|Parent Skills Training|Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
16359648|NCT00183365|Behavioral|Protecting Families Program (PFP)|Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child.
16359649|NCT00183339|Drug|Fluoxetine|Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
16359650|NCT00183339|Drug|Placebo|Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
16359651|NCT00183326|Behavioral|Trauma-focused cognitive behavioral therapy (TF-CBT)|TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.
16359652|NCT00183326|Behavioral|Child-centered supportive therapy (CCT)|CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.
16359653|NCT00183313|Behavioral|Nurse case management|Nurse case management is a population-based medical case management program to improve the delivery of primary medical care to patients with serious mental illness in a Community Mental Health Center (CMHC) in Atlanta GA. The treatment draws on elements from the primary care, nursing case management, chronic disease, health behavior change literature, and from the study team's experience in integrating primary care services for patients with serious mental illnesses.
16359654|NCT00183313|Behavioral|Usual care|Usual care includes standard mental health services.
16359655|NCT00183300|Behavioral|Prolonged Exposure Therapy|
16359656|NCT00183274|Drug|Venlafaxine XR|Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
16359657|NCT00183274|Drug|Placebo|six month intervention with placebo drug
16359658|NCT00183261|Biological|MRKAd5 HIV-1 gag/pol/nef|1.5 x 1010 Ad vg/mL, 1.0 mL administered intramuscularly
16359659|NCT00183261|Biological|MRKAd5 HIV-1 gag/pol/nef placebo|1.0 mL administered intramuscularly
16359660|NCT00183248|Drug|Alemtuzumab|Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
16359661|NCT00183248|Drug|Mycophenolate mofetil|Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
16359662|NCT00183248|Drug|Sirolimus|Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
16359663|NCT00183248|Drug|Tacrolimus|Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
16359664|NCT00183248|Procedure|Donor bone marrow stem cell infusion|2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6
16359665|NCT00183248|Procedure|Kidney transplant|Occurs at study entry
16359666|NCT00183235|Drug|aripiprazole (up to 15 mg/day) for 8 days|
16359667|NCT00183222|Drug|naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days|
16359668|NCT00183209|Behavioral|Family First|Family First = 14 sessions lasting 1.5 hours each based on Social Action Theory and Motivational Interviewing (7 sessions on reducing alcohol and drug use and 7 sessions on reducing parenting challenges). Brief Video Intervention was a single session designed to increase motivation to reduce/eliminate problem drinking or drug use.
16359669|NCT00183196|Drug|Naltrexone|Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
16359670|NCT00183196|Drug|Naltrexone plus Gabapentin|naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
16359671|NCT00183196|Other|Inactive Placebo|Placebo
16359672|NCT00183183|Behavioral|Screening and Brief Intervention|
16359673|NCT00183170|Drug|Alcohol|Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks.
16359674|NCT00183170|Other|Placebo|Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.
16359675|NCT00183157|Behavioral|Brief Motivational Intervention|One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
16359676|NCT00183157|Behavioral|Assessment and list of resources|One-third will receive only the assessment and a list of community resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
16359738|NCT00182650|Biological|rituximab|
16359677|NCT00183157|Behavioral|Referral to Community Resources|All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive only a list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.
16359678|NCT00183144|Behavioral|Contingency management|
16359679|NCT00183131|Behavioral|Brief Personalized Feedback|
16359680|NCT00183118|Behavioral|Adapted Enhanced-RESPECT (HIV prevention intervention)|
16359681|NCT00183105|Behavioral|Brief Intervention (adaptation of motivational interviewing)|
16359682|NCT00183092|Drug|Quinacrine|100mg by mouth three times a day
16359683|NCT00183092|Drug|Placebo|100mg by mouth three times a day
16359684|NCT00183079|Behavioral|Motivationally-focused brief alcohol intervention|Brief, motivationally-focused alcohol intervention
16359685|NCT00183053|Device|BedEx Patient Occupancy Monitoring System|
16359686|NCT00183040|Drug|Topical testosterone|
16359687|NCT00183040|Drug|Recombinant human growth hormone|
16359688|NCT00183027|Behavioral|Dietary composition and energy intake|
16359689|NCT00183014|Behavioral|The Lifetime Fitness Program|A series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
16359690|NCT00183014|Behavioral|Exercise class|1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
16359691|NCT00183001|Drug|Vitamin K|
16359692|NCT00182975|Drug|DHEA replacement|
16359693|NCT00182962|Behavioral|Geriatric Resources for Assessment & Care of Elders (GRACE)|
16359694|NCT00182936|Behavioral|Delirium Abatement Program|
16359695|NCT00182897|Behavioral|Skills Building for Caregiver Health and Care-recipient|
16359696|NCT00182884|Drug|Donepezil|
16359697|NCT00182871|Drug|testosterone|
16359698|NCT00182845|Drug|Donepezil|
16359699|NCT00182832|Behavioral|e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)|Cognitive screening plus Computerized Decision Support System: proactive screening program for cognitive impairment combined with computerized review of the electronic medical record
16359700|NCT00182832|Behavioral|Standard Care|Standard care for hospitalized older patients with cognitive impairment
16359701|NCT00182819|Drug|temozolomide|Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
16359702|NCT00182819|Radiation|radiation therapy|50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
16359703|NCT00182806|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.
16359704|NCT00182806|Drug|irinotecan hydrochloride|IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.
16359705|NCT00182793|Biological|trastuzumab|Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion
16359706|NCT00182793|Drug|carboplatin|Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
16359707|NCT00182793|Drug|cyclophosphamide|Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
16359708|NCT00182793|Drug|melphalan|Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion
16359709|NCT00182793|Drug|thiotepa|Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
16359710|NCT00182793|Procedure|adjuvant therapy|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy.
16359711|NCT00182793|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.
16359712|NCT00182793|Procedure|bone marrow ablation with stem cell support|Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation
16359713|NCT00182793|Radiation|radiation therapy|"After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy.
~Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy."
16359714|NCT00182780|Dietary Supplement|American ginseng|
16359715|NCT00182780|Other|Placebo|
16359716|NCT00182767|Drug|ixabepilone|Given IV
16359717|NCT00182767|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16359718|NCT00182754|Drug|octreotide acetate|Given subcutaneously
16359719|NCT00182754|Other|placebo|Given subcutaneously
16359720|NCT00182741|Dietary Supplement|calcitriol|
16359721|NCT00182741|Drug|mitoxantrone hydrochloride|
16359722|NCT00182741|Drug|prednisone|
16359723|NCT00182728|Procedure|surgery|conventional
16359724|NCT00182728|Procedure|therapy|neoadjuvant
16359725|NCT00182728|Radiation|radiation therapy|intraoperative radiation therapy
16359726|NCT00182715|Biological|cetuximab|
16359727|NCT00182715|Drug|capecitabine|
16359728|NCT00182715|Drug|fluorouracil|
16359729|NCT00182715|Drug|leucovorin calcium|
16359730|NCT00182715|Drug|oxaliplatin|
16359731|NCT00182702|Drug|ixabepilone|Given IV
16359732|NCT00182702|Other|laboratory biomarker analysis|Correlative studies
16359733|NCT00182689|Drug|sorafenib tosylate|Given orally
16359734|NCT00182663|Drug|clarithromycin|Given PO
16359735|NCT00182663|Drug|thalidomide|Given PO
16359740|NCT00182650|Drug|fludarabine phosphate|
16359741|NCT00182637|Drug|bortezomib|
16359742|NCT00182611|Drug|cisplatin|
16359743|NCT00182611|Drug|tegafur-gimeracil-oteracil potassium|
16359744|NCT00182611|Procedure|adjuvant therapy|
16359745|NCT00182611|Procedure|conventional surgery|
16359746|NCT00182611|Procedure|neoadjuvant therapy|
16359747|NCT00182598|Procedure|computer-based psychoeducational intervention|
16359748|NCT00182598|Procedure|community-based substance abuse counseling|
16359749|NCT00182585|Procedure|computer-based HIV, STD & Hepatitis Education|
16359750|NCT00182585|Procedure|educator-delivered HIV, STD and Hepatitis education|
16359751|NCT00182572|Drug|buprenorphine|
16359752|NCT00182572|Drug|naltrexone|
16359753|NCT00182572|Procedure|behavior therapy|
16359754|NCT00182572|Procedure|voucher-based contingency management|
16359755|NCT00182559|Drug|Ciclosporin|Maintain ciclosporin in combination with/without mycophenolate mofetil and with/without steroids at target trough levels of 70-150ng/mL.
16359756|NCT00182559|Drug|Tacrolimus|Conversion from ciclosporin to tacrolimus at target trough levels of 5-8 ng/mL in combination with/without mycophenolate mofetil and with/without steroids.
16359757|NCT00182546|Procedure|Two diagnostic management strategies|
16359758|NCT00182533|Drug|Sertraline|25 - 200 mg/day x 16 weeks
16359759|NCT00182533|Drug|Placebo|25 - 200 mg/day x 16 weeks
16359760|NCT00182520|Drug|Topiramate|25 mg - 400 mg/day x 12 weeks
16359761|NCT00182520|Drug|placebo|25 - 400 mg/day x 12 weeks
16359762|NCT00182507|Drug|Olanzapine|
16359763|NCT00182494|Behavioral|Modified diabetes prevention protocol & Metformin|
16359764|NCT00182481|Procedure|Induced sputum cell counts|
16359765|NCT00182481|Drug|inhaled corticosteroids and other asthma drugs|
16359766|NCT00182468|Other|Screening for intimate partner violence|Women are screened for intimate partner violence prior to seeing a health care provider.
16359767|NCT00182455|Drug|Topiramate|25 - 400 mg/day x 12 weeks
16359768|NCT00182455|Drug|Placebo|25 - 400 mg/day x 12 weeks
16359769|NCT00182442|Drug|Olanzapine & Quetiapine|
16359770|NCT00182429|Drug|Metronidazole and Rifampin|
16359771|NCT00182416|Device|pacemaker|
16359772|NCT00182403|Drug|UFH 250 U/kg or LMWH 100 U/kg sc twice daily|
16359773|NCT00182390|Procedure|Red blood cell transfusion|
16359774|NCT00182377|Drug|Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)|
16359775|NCT00182364|Drug|Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)|
16359776|NCT00182351|Procedure|D-dimer|
16359777|NCT00182351|Procedure|Serial Compression Ultrasound|
16359778|NCT00182325|Behavioral|personalized web prenatal information|
16359779|NCT00182325|Behavioral|general web prenatal information|
16359780|NCT00182312|Drug|Caffeine citrate injection|"Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
~Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
~Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy."
16359781|NCT00182299|Procedure|porcine small intestine submucosa (SIS)|
16359782|NCT00182286|Behavioral|Assessment of continuity of care from the patient perspective|
16359783|NCT00182286|Behavioral|Relationship between continuity of care, patient outcomes, and costs|
16359784|NCT00182273|Procedure|Canalith repositioning maneuver (CRM)|
16359785|NCT00182260|Drug|Proton Pump Inhibitors|
16359786|NCT00182260|Procedure|Laparoscopic Nissen Fundoplication|
16359787|NCT00182247|Procedure|venogram|
16359788|NCT00182234|Behavioral|Community Interlink Program|The study intervention is a referral to a specialized oncology nursing program. The standardized care provided by this program includes comprehensive assessment and care planning specific to breast and colorectal cancers during the initial phases of treatment, with a minimum of two home visits. Through consultation with the patient, nurses either provide direct (non-medical) care to address needs identified and/or coordinate linkage to services in the community.
16359789|NCT00182221|Procedure|MDA D-Dimer Testing|
16359790|NCT00182208|Device|Veno-device (Venowave)|
16359791|NCT00182195|Procedure|Control Ventilation Strategy|
16359792|NCT00182182|Behavioral|Primary care based disease management strategy|
16359793|NCT00182169|Drug|Human recombinant growth hormone|
16359794|NCT00182143|Drug|LMWH (Fragmin, dalteparin)|Placebo AM dose (normal saline) and LMWH (Fragmin, dalteparin) 5000IU PM dose
16359795|NCT00182143|Drug|Unfractionated Heparin|5000 IU BID
16359796|NCT00182130|Procedure|Quality Initiative in Rectal Cancer (QIRC) strategy|
16359797|NCT00182104|Drug|Warfarin vs ASA|
16359798|NCT00182091|Drug|Recombinant human growth hormone|Starting dose based on age, sex, and estrogen status and ranged from 3-6 mcg/kg/day. GH doses were adjusted based on IGF-1 levels to target the mid-normal range for age.
16359799|NCT00182091|Drug|Saline|To maintain study-subject blinding, doses were sham adjusted.
16359800|NCT00182078|Drug|Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
16359801|NCT00182078|Drug|Sertraline|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
16359802|NCT00182052|Drug|Rosiglitazone|Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.
16359803|NCT00182052|Other|Placebo|Given orally twice daily.
16359804|NCT00182039|Drug|Metoprolol controlled release (CR)|Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
16359805|NCT00182039|Drug|Placebo|Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
16359806|NCT00182026|Behavioral|personal feedback report|A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
16359807|NCT00182013|Drug|Risperidone|Open treatment with Risperidone
16359808|NCT00182013|Drug|Olanzapine|Open treatment with Olanzapine
16359809|NCT00182013|Drug|Quetiapine|Open treatment with Quetiapine
16359810|NCT00182000|Drug|seromycin|100mg tablet administered 1 hour prior to each therapy session
16359811|NCT00182000|Behavioral|Behavior Therapy|10 weekly hour-long behavior therapy sessions
16359812|NCT00181987|Drug|methylphenidate HCl (Concerta)|
16359813|NCT00181974|Drug|Tisseel Fibrin Sealant|
16359814|NCT00181961|Drug|Maca Root|
16359815|NCT00181948|Drug|atomoxetine (Strattera)|
16359816|NCT00181935|Drug|risperidone (Risperdal)|
16359817|NCT00181935|Drug|olanzapine (Zyprexa)|
16359818|NCT00181922|Drug|ziprasidone (Geodon)|
16359819|NCT00181909|Behavioral|Smoking cessation counseling delivered by telephone|
16359820|NCT00181896|Drug|bupropion SR|Open-label prescription of Bupropion SR for 8 weeks.
16359821|NCT00181883|Drug|quetiapine|2.5 - 5.0mg/kg PO BID quetiapine
16359822|NCT00181870|Drug|carbamazepine ER (Equetro)|
16359823|NCT00181844|Drug|lamotrigine|Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
16359824|NCT00181831|Device|Proton Magnetic Resonance Spectroscopy|
16359825|NCT00181818|Drug|bupropion SR (sustained-release)|
16359826|NCT00181779|Drug|aripiprazole (Abilify)|
16359827|NCT00181766|Drug|Strattera (atomoxetine)|Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
16359828|NCT00181753|Drug|standard vs. glutamine enteral or parenteral feeding.|Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
16359829|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours of primed constant infusion
16359830|NCT00181753|Dietary Supplement|Stable isotope study|7 hours of primed constant infusion of stable isotope tracers.
16359831|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours of primed constant stable isotope tracer infusion.
16359832|NCT00181753|Dietary Supplement|Stable isotope tracer study|7 hours primed constant infusion of stable isotope tracer study
16359833|NCT00181740|Drug|atomoxetine (Strattera)|
16359834|NCT00181727|Drug|divalproex sodium extended release|
16359835|NCT00181714|Drug|methylphenidate HCl (Concerta)|OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
16359836|NCT00181701|Drug|Paclitaxel|
16359837|NCT00181701|Drug|Carboplatin|
16359838|NCT00181688|Drug|Iressa (ZD1839)|
16359839|NCT00181688|Drug|Arimidex (Anastrozole)|
16359840|NCT00181675|Drug|galantamine HBr|
16359841|NCT00181662|Drug|Curcumin|
16359842|NCT00181649|Drug|Recombinant human prolactin|
16359843|NCT00181636|Drug|Galantamine-CR|
16359844|NCT00181623|Drug|Recombinant Human Prolactin|
16359845|NCT00181610|Drug|Recombinant Human Prolactin|60 mcg/kg every 12 hours
16359846|NCT00181610|Biological|Recombinant human prolactin|60 mcg/kg given every 12 hours or every 24 hours
16359847|NCT00181610|Biological|Normal Saline|twice per day
16359848|NCT00181597|Drug|Trilostane|Taken orally once a day for three days then twice daily thereafter.
16359849|NCT00181597|Drug|Hydrocortisone|Taken orally with trilostane.
16359850|NCT00181584|Drug|Zoledronic acid|Given intravenously once.
16359851|NCT00181584|Other|Placebo|Given intravenously once.
16359852|NCT00181571|Drug|methylphenidate HCl (Concerta)|up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.
16359853|NCT00181571|Drug|Placebo|up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.
16359854|NCT00181558|Drug|Atrasentan|
16359855|NCT00181558|Drug|Zoledronic Acid (Zometa)|
16359856|NCT00181545|Procedure|escalation of dose (radiotherapy treatment)|
16359857|NCT00181532|Drug|Celecoxib|
16359858|NCT00181506|Procedure|dose escalation (radiotherapy treatment schedule)|
16359859|NCT00181363|Device|Mamma board|use of mamma board during radiotherapy
16359860|NCT00181350|Device|Relocatable fixation system|
16359861|NCT00181311|Procedure|hysterectomy|
16359862|NCT00181298|Drug|Memantine|Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4.
16359863|NCT00181298|Drug|Placebo|Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4
16359864|NCT00181285|Device|High Frequency Chest Wall Oscillator|High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
16359865|NCT00181272|Drug|azithromycin|
16359866|NCT00181246|Drug|Transdermal Fentanyl|
16359867|NCT00181220|Drug|valproic acid|
16359868|NCT00181207|Device|pneumatic vest|
16359869|NCT00181207|Other|placebo pneumatic vest|
16359870|NCT00181194|Device|Asthma Control and Communication Instrument|
16359871|NCT00181181|Drug|atorvastatin|Atorvastatin 80 mg daily for 3 months
16359872|NCT00181181|Other|placebo|placebo daily
16359873|NCT00181168|Drug|Euthyroid Group|Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
16359874|NCT00181155|Drug|Allopurinol|intravenous infusion of allopurinol (300mg)
16359875|NCT00181155|Drug|Placebo|intravenous infusion of 50 ml dose of 5% dextrose
16359876|NCT00181142|Drug|Zenapax|
16359877|NCT00181129|Behavioral|home based self paced walking program|
16359878|NCT00181116|Drug|Levetiracetam|
16359879|NCT00181090|Behavioral|Modified Atkins diet|
16359880|NCT00181077|Drug|2% buffered hypertonic saline administration|
16359881|NCT00181064|Behavioral|Modified Atkins diet|15 grams of carbohydrates per day - high fat diet
16359882|NCT00181051|Device|Alaris AEP monitor|
16359883|NCT00181038|Device|Peri-Neuronal Catheter|
16359884|NCT00181025|Drug|Tasonermine (TNFa)|
16359885|NCT00181025|Drug|Melphalan|
16359886|NCT00181012|Drug|Lidocaine|
16359887|NCT00180999|Drug|Erythropoiétine|
16359888|NCT00180986|Procedure|Platelet concentrates|
16359889|NCT00180973|Drug|Hydroxyurea|
16359890|NCT00180960|Drug|Oxaliplatin and irinotecan|
16359891|NCT00180947|Drug|Vinorelbine, cyclofosfamide|
16359892|NCT00180934|Procedure|Reirradiation with concomitant chemotherapy|
16359893|NCT00180921|Drug|Imatinib|
16359894|NCT00180908|Drug|Etoposide, Ifosfamide, Methotrexate|
16359895|NCT00180908|Drug|Doxorubicin, Methotrexate|
16359896|NCT00180895|Drug|Rituximab|
16359897|NCT00180882|Drug|rituximab|
16359898|NCT00180869|Procedure|transfusion of allogeneic red blood cell concentrate|
16359899|NCT00180869|Procedure|transfusion of leuko-reduced red blood cell concentrate|
16359900|NCT00180856|Procedure|Radiofrequency ablation|
16359901|NCT00180843|Drug|salbutamol + ipratropium bromide nebules|
16359902|NCT00180843|Drug|nebulized saline|
16359903|NCT00180830|Drug|Glivec|
16359904|NCT00180830|Drug|Gleevec|
16359905|NCT00180791|Drug|Etoposide, carboplatin, melphalan, cisplatin, thiotepa|
16359906|NCT00180778|Drug|Low dose steroids|
16359907|NCT00180765|Procedure|Up to 100ml blood will be taken by venupuncture.|
16359908|NCT00180739|Procedure|Magnetic Resonance Guided Focused Ultrasound|
16359909|NCT00180726|Procedure|Blood sampling, Endoscopic Bronchoscopy, Spirometry|
16359910|NCT00180713|Drug|Simvastatin|Simvastatin 40mg od for 1 month, then 80mg od for 11 months
16359911|NCT00180713|Drug|Placebo|Placebo tablet once daily.
16359912|NCT00180700|Behavioral|Hypnosis|
16359913|NCT00180687|Drug|Nebulised Bupivacaine intraperitoneally|Nebulised Marcaine (Bupivacaine)
16359914|NCT00180687|Drug|Normal Saline|Nebulised Normal Saline
16359915|NCT00180687|Drug|Injected Bupivacaine intraperitoneally|Injected Marcaine directly into the peritoneal cavity
16359916|NCT00180687|Other|No Intraperitoneal Therapeutics|No Intraperitoneal Therapeutics given
16359917|NCT00180674|Drug|Warfarin|
16359918|NCT00180635|Drug|Aminoguanidine|500mg
16359919|NCT00180635|Drug|Placebos|2ml
16359920|NCT00180622|Procedure|Spirometry|
16359921|NCT00180622|Procedure|Exhaled Nitric Oxide and Carbon Monoxide|
16359922|NCT00180622|Procedure|Exhaled Breath Condensate|
16359923|NCT00180622|Procedure|Induced Sputum|
16359924|NCT00180622|Procedure|CT Scan|
16359925|NCT00180622|Procedure|Blood test|
16359926|NCT00180622|Procedure|St Georges Questionnaire|
16359927|NCT00180622|Procedure|Bodypletysmography|
16359928|NCT00180609|Device|Automatic threshold test in Insignia Pacemakers from Guidant|
16359929|NCT00180596|Device|Contak heart failure devices|
16359930|NCT00180583|Device|Guidant GALILEO Intravascular Radiotherapy System|Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
16359931|NCT00180570|Device|FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ|
16359932|NCT00180557|Device|Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip|
16359933|NCT00180544|Device|Stenting: Renal Artery|Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses.
16359934|NCT00180531|Device|Renewal TR2|
16359935|NCT00180518|Device|Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system|"Two rapid exchange devices will be evaluated: the RX ACCUNET Embolic Protection System (RX ACCUNET) and the RX ACCULINK Carotid Stent System (RX ACCULINK).
~The RX ACCUNET Embolic Protection System is intended to facilitate the placement of diagnostic and therapeutic devices during interventional procedures and to capture embolic material that may be present during carotid artery interventional procedures.
~The RX ACCULINK™ Carotid Stent System is intended for the treatment of carotid artery stenosis in the internal carotid artery (ICA), with or without involvement of the contiguous common carotid artery (CCA), in asymptomatic patients and symptomatic patients."
16360047|NCT00179413|Drug|Colchicine|0.6mg twice a day
16360048|NCT00179400|Drug|Pioglitazone 45 mg|
16360049|NCT00179400|Drug|Placebo|
16360050|NCT00179387|Behavioral|Mind-Body Psychotherapy Group|Psycho-educational group
16359936|NCT00180505|Device|ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent|A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.
16359937|NCT00180492|Device|RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System|
16359938|NCT00180479|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16359939|NCT00180479|Device|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16359940|NCT00180453|Device|Coronary artery drug eluting stent placement|Coronary artery drug eluting stent placement
16359941|NCT00180453|Device|Coronary artery stent placement|Coronary artery stent placement
16359942|NCT00180440|Device|ICD|all models of Guidant/Bsc ICD's
16359943|NCT00180427|Device|ICD|
16359944|NCT00180414|Device|CRT devices with ventricular rate regulation [VRR] (CE labeled)|
16359945|NCT00180401|Behavioral|CRT-P and CRT-D devices|
16359946|NCT00180388|Procedure|endoscopic vein harvesting|
16359947|NCT00180388|Procedure|open vein harvesting|
16359948|NCT00180375|Device|Prizm, Vitality, Renewal|Follow-up during 2 years
16359949|NCT00180362|Device|procedure|
16359950|NCT00180349|Device|Endotak Reliance|Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.
16359951|NCT00180336|Device|CRT-D|
16359952|NCT00180323|Device|Renewal|Renewal is a CRT-D device for cardiac resynchronization therapy
16359953|NCT00180310|Device|XIENCE V® Everolimus Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16359954|NCT00180310|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease
16359955|NCT00180297|Device|Endotak Reliance G|Reliance G is a defibrillation lead to be placed in the right ventricle.
16359956|NCT00180284|Device|SITELINE 2 Polyurethane (pacing lead)|SITELINE 2 Polyurethane (pacing lead)
16359957|NCT00180271|Device|Cardiac resynchronization therapy with defibrillation|Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
16359958|NCT00180271|Device|Implantable Cardioverter Defibrillator (ICD)|Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
16359959|NCT00180258|Device|Cardiac Resynchronization Therapy with & without defibrillator|
16359960|NCT00180206|Device|Birmingham Hip Resurfacing|
16359961|NCT00180167|Drug|randomization between two established Chemotherapies|
16359962|NCT00180141|Drug|Elidel-Creme|
16359963|NCT00180128|Drug|all-trans retinoid acid|
16359964|NCT00180128|Drug|idarubicin|
16359965|NCT00180128|Drug|mitoxantrone|
16359966|NCT00180128|Drug|daunorubicin|
16359967|NCT00180128|Drug|cytarabine|
16359968|NCT00180115|Drug|Cytarabine Dosage|
16359969|NCT00180102|Drug|Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone|
16359970|NCT00180102|Procedure|early allogeneic PBSCT within induction therapy|
16359971|NCT00180102|Procedure|autologous PBSCT|
16359972|NCT00180089|Drug|Budesonide|
16359973|NCT00180076|Drug|Budesonide|
16359974|NCT00180063|Drug|L-NMMA(drug)|
16359975|NCT00180050|Drug|Budesonide|
16359976|NCT00180037|Drug|Coenzyme Q10 Nanodispersion (Nanoquinone)|
16359977|NCT00180037|Drug|Placebo|
16359978|NCT00180024|Drug|irbesartan (drug)|
16359979|NCT00180011|Drug|Omalizumab|injectable medication
16359980|NCT00179998|Drug|Recombinant Human DNase (Pulmozyme)|2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months
16359981|NCT00179998|Drug|Placebos|2.5 ml sterile solution (8.77 mg/ml sodium chloride, 0.15 mg/ml calcium chloride, pH 7.0 +/- 2.0) delivered daily by nebulization for 6 months, either preceding or following 6 months of Pulmozyme depending on randomization of the subject
16359982|NCT00179972|Device|Adhesive and non-adhesive oximetry sensors|A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.
16359983|NCT00179959|Drug|Sodium hypochlorite (bleach) baths|Sodium hypochlorite (bleach) baths twice weekly for 3 months
16359984|NCT00179959|Drug|Mupirocin ointment|Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)
16359985|NCT00179959|Drug|Water|Water baths twice weekly for three months
16359986|NCT00179959|Drug|Petrolatum Ointment|Intranasal petrolatum ointment twice daily for five days
16359987|NCT00179946|Procedure|HLA typing|
16359988|NCT00179933|Behavioral|Newborn Individualized Assessment Program|
16359989|NCT00179920|Drug|Carboplatin|
16359990|NCT00179920|Drug|VP-16|
16359991|NCT00179920|Procedure|Local Surgery|
16359992|NCT00179920|Procedure|Cryotherapy|
16359993|NCT00179920|Procedure|Laser hyperthermia|
16359994|NCT00179907|Procedure|Photon Radiosurgery System (Intrabeam)|In this study we had intended to perform a similar dose escalation study with doses ranging from 10-19 Gy, 10-16 Gy and 10 - 14 Gy for tumors < 20 mm, 21-25 mm and 26-40 mm respectively
16359995|NCT00179894|Behavioral|Physician training|Physicians are trained in guidelines for medication management.
16359996|NCT00179881|Drug|Carboplatin|
16359997|NCT00179881|Drug|Thalomid|
16359998|NCT00179881|Procedure|External Beam Radiation Therapy|
16360051|NCT00179387|Behavioral|Mind-Body Psychotherapy Group|Spiritual-Existential Group
16360052|NCT00179374|Behavioral|Tailored telephone intervention of education|Tailored telephone intervention to promote metabolic control of diabetes
16368162|NCT00110487|Drug|ERB-041|
16359999|NCT00179868|Behavioral|C-Reactive Protein levels|"Each patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications:
~Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
~Acute GVHD > grade II defined according to the Seattle criteria
~VOD- defined according to the modified Seattle criteria"
16360000|NCT00179855|Procedure|Extracorporeal Photopheresis|"ECP will be performed using the UVAR® XTS™ photopheresis system (Therakos). Whole blood is drawn and separated by centrifuge to collect the buffy coat (lymphocyte solution). Methoxsalen (8-MOP) is added to the blood, and the final solution of cells is passed as a film, 1mm thick, through a disposable plastic device, exposed to a UVA light source (2J/cm2/cell) and then returned to the patient.
~ECP will be performed weekly on 2 consecutive days for 4 weeks. After 4 weeks the interval will be prolonged to every 2 weeks and ECP will be stopped after maximal response has been maintained for 2 weeks. The actual study finishes at d56 but ECP may be continued beyond that (off-study) at the discretion of the physician."
16360001|NCT00179842|Procedure|Stem Cell Transplant|
16360002|NCT00179829|Procedure|WT 1 Testing|
16360003|NCT00179816|Drug|High-Dose Chemotherapy with Tandem PBSC Rescue.|Patients on this study will undergo a tandem Peripheral Blood Stem Cell Rescue following high-dose chemotherapy. The first Peripheral Blood Stem Cell Rescue will consist of Etoposide, Carboplatin, Cyclophosphamide, and Mesna. Once the patient recovers, the patient will be evaluated again and will then undergo a second stem cell transplant consisting of the chemotherapy drugs; Melphalan, Cyclophosphamide, and Mesna.
16360004|NCT00179803|Procedure|Stem Cell Transplant|"Group A: recurrent medulloblastoma, recurrent germ cell tumor
~Cytoxan treatment
~Stem cell autologous harvest
~Group B: GBM, high grade astrocytoma, rhabdoid tumors, pineoblastoma, or supratentorial PNET
~Carboplatin and Etoposide treatment
~Autologous stem cell harvest
~The preparatory regimen used for Stem Cell Rescue #1 will be Carboplatinum, VP-16 and Thiotepa. If the patient has recuperated his ANC to >1,000 within 50 days after Stem Cell Rescue #1, (sustained without G-CSF support) a neuroradiographic evaluation will be performed. If there is lack of progression, the patient will then proceed to Stem Cell Rescue # 2 with Cyclophosphamide and Melphalan, followed by stem cell rescue."
16360005|NCT00179790|Procedure|Extracorporeal Photopheresis|Patient will undergo ECP treatment pre and post stem cell transplant infusion
16360006|NCT00179777|Dietary Supplement|Hydrolysed infant formula|Participants in the Hydrolysed infant formula -group received the test formula, casein hydrolysate (Nutramigen™, Mead Johnson Nutritionals), not containing antigenic CM protein, whenever breast milk is not available.
16360007|NCT00179777|Dietary Supplement|Nonhydrolysed infant formula|Participants in the Nonydrolysed infant formula -group received the CM protein containing control formula which has an addition (20 %) of Nutramigen, whenever breast milk is not available.
16360008|NCT00179764|Procedure|Immunoablative Hematopoietic PBSC Transplant|Immunoablative conditioning chemotherapy regimen, followed by transplantation of peripheral blood stem cells on Day 0 of the conditioning regimen.
16360009|NCT00179764|Procedure|Busulfan pharmacokinetics|Pharmacokinetics of once-a-day dosing of intravenous busulfan as a 3-hour infusion
16360010|NCT00179764|Radiation|Central Nervous System (CNS) prophylaxis radiation|"Patients diagnosed with ALL over 1 year of age and without prior CNS disease will receive CNS prophylaxis radiation to the whole brain prior to transplant.
~Patients diagnosed with ALL with prior CNS disease over the age of 1 year will be treated with prophylaxis radiation to the whole brain and spine prior to transplant."
16360011|NCT00179751|Drug|CC-5013|
16360012|NCT00179751|Drug|gemcitabine|
16360013|NCT00179738|Drug|CC5013|
16360014|NCT00179725|Drug|CC-5013|
16360015|NCT00179725|Drug|liposomal doxorubicin|
16360016|NCT00179712|Drug|CC-5013|
16360017|NCT00179712|Drug|topotecan|
16360018|NCT00179699|Drug|CC-5013|
16360019|NCT00179699|Drug|pemetrexed|
16360020|NCT00179686|Drug|CC-5013|
16360021|NCT00179673|Drug|Lenalidomide|Lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed
16360022|NCT00179660|Drug|Lenalidomide|Capsules for oral administration.
16360023|NCT00179647|Drug|lenalidomide|Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone
16360024|NCT00179647|Drug|dexamethasone|Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens
16360025|NCT00179634|Behavioral|Visualization relaxation|
16360026|NCT00179634|Behavioral|Visual Milieu Enhancement (Fine art photograph)|
16360027|NCT00179621|Drug|Lenalidomide 5 mg|Lenalidomide 5 mg daily 28/28 days
16360028|NCT00179621|Drug|Lenalidomide 10 mg|Lenalidomide 10 mg daily 21/28 days
16360029|NCT00179621|Drug|Placebo|Placebo, matching to active study drug arms
16360030|NCT00179608|Drug|CC-5013|
16360031|NCT00179595|Behavioral|relaxation response- meditation|
16360032|NCT00179582|Drug|VSL#3|
16360033|NCT00179569|Behavioral|Relaxation response|8 weeks of relaxation response training
16360034|NCT00179556|Drug|Isoflavone supplement|
16360035|NCT00179543|Behavioral|Relaxation response|
16360036|NCT00179530|Behavioral|Relaxation Response|Relaxation training
16360037|NCT00179517|Drug|Anastrozole 1mg|
16360038|NCT00179517|Drug|Placebo Oral Tablet|
16360039|NCT00179504|Behavioral|Relaxation Response|Relaxation training
16360040|NCT00179491|Behavioral|Intercessory Prayer|14 days of intercessory prayer from 3 sites
16360041|NCT00179478|Drug|interferon beta 1a 30 ug IM once weekly|Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.
16360042|NCT00179465|Drug|Tiagabine|Up to 36 mg daily
16360043|NCT00179465|Drug|Placebo|Placebo
16360044|NCT00179452|Behavioral|Yoga|
16360045|NCT00179439|Procedure|nasal potential difference testing|
16360046|NCT00179413|Drug|PEG -Intron|
16360053|NCT00179374|Behavioral|Print educational intervention|diabetes educational materials by mail
16360054|NCT00179348|Procedure|Quality-of-Life Assessment|Ancillary studies
16360055|NCT00179348|Procedure|Yoga|Undergo a yoga-based rehabilitation program
16360056|NCT00179335|Procedure|Blood drawing to determine drug levels|
16360057|NCT00179309|Drug|Docetaxel|35 mg/m^2 intravenous 30-60 minutes once a week for 3 consecutive weeks with 1 week off drug.
16360058|NCT00179309|Biological|PANVAC-V|2 x 10^8 PFU
16360059|NCT00179309|Biological|PANVAC-F|1 x 10^9 PFU
16360060|NCT00179309|Biological|Sargramostim|Given subcutaneously under the skin, usually in the thigh on the day of vaccination and daily for the next 3 days.
16360061|NCT00179283|Drug|sertraline|
16360062|NCT00179283|Drug|venlafaxine XR|
16360063|NCT00179257|Drug|sertraline (Zoloft)|
16360064|NCT00179244|Drug|Rispridone (drug) and Bupropion ER (drug)|
16360065|NCT00179231|Drug|olanzapine vs. clozapine|
16360066|NCT00179218|Drug|nutritional supplementation|oral administration of 2 cans of protein supplement (lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat); every other day, 3 days per week, for 6 months
16360067|NCT00179218|Behavioral|exercise|leg press exercise; every other day, 3 days per week, for 6 months
16360068|NCT00179205|Drug|Nepro nutritional supplement|oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.
16360069|NCT00179205|Drug|placebo|oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.
16360070|NCT00179192|Procedure|angioplasty|angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
16360071|NCT00179192|Procedure|surgery|surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
16360072|NCT00179179|Drug|nutritional supplementation|2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period
16360073|NCT00179179|Behavioral|exercise|resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period
16360074|NCT00179166|Drug|TPN nutritional supplement|intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)
16360075|NCT00179153|Dietary Supplement|Nepro nutritional supplement|oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months
16360076|NCT00179140|Drug|nutritional supplementation|oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat
16360077|NCT00179140|Behavioral|exercise|either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months
16360078|NCT00179127|Drug|glargine|0.3u/kg of glargine, subcutaneously, once
16360079|NCT00179127|Drug|saline|0.3u/kg of saline, subcutaneously, once
16360080|NCT00179114|Drug|Botulinum Toxin Type A|
16360081|NCT00179114|Drug|Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)|
16360082|NCT00179101|Procedure|Deep Brain Stimulation|
16360083|NCT00179088|Behavioral|Patient may be able to put weight on the operated leg|
16360084|NCT00179062|Drug|olanzapine versus risperidone|Participants are to be randomized to olanzapine or risperidone. Antipsychotic medication will be given as per package insert daily for the twelve month duration of the trial.
16360085|NCT00179023|Drug|Trimethaphan|Start dose: 0.05 ml/min (0.5 mg/min), IV infusion. The dose will be increased every 2-4 minutes to 1, 2, 4, and 5 mg/min. Total duration: 1 hour
16360086|NCT00179023|Drug|Trimethaphan|Start dose: 0.05 ml/min (0.5 mg/min), IV infusion. The dose will be increased every 30 minutes to 1, 2, 4, and 5 mg/min. Total duration: 1-2 hours
16360087|NCT00179023|Drug|Pseudoephedrine|30mg tablet,VO. Single dose.
16360088|NCT00179010|Drug|Adenosine|Adenosine intrarterial (intrabrachial) infusion at 3 diferent doses for 15 minutes each
16360089|NCT00179010|Drug|Adenosine Mono Phosphate (AMP)|Intraterial infusion of AMP at 3 different doses for 15 minutes each (at equimolar doses as adenosine)
16360090|NCT00178971|Drug|adjunctive treatment with buspirone|buspirone 15-30 mg qd
16360091|NCT00178971|Drug|placebo|placebo
16360092|NCT00178958|Device|Holter Monitor|
16360093|NCT00178945|Drug|Botulinum Toxin Type A|
16360094|NCT00178932|Procedure|genetic analysis|genetic assay of blood sample drawn with patient's consent
16360095|NCT00178932|Procedure|genetic assay|genetic assay of blood sample drawn with patient's consent
16360096|NCT00178919|Drug|L-NMMA|IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third.
16360097|NCT00178919|Drug|Trimethaphan|IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.
16360098|NCT00178854|Drug|Risperidone|
16360099|NCT00178841|Drug|Rosiglitazone and Bexarotene|rosiglitazone added to bexarotene capsules
16360100|NCT00178828|Drug|sertraline|Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
16368402|NCT00108849|Drug|estradiol, 10 mcg|
16360101|NCT00178828|Drug|bupropion|Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
16360102|NCT00178802|Other|thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)|"5-fluorouracil 400 mg/m2 i.v. over 24 hours for 5 days
~Doxil (liposomal doxorubicin) 40 mg/m2 over 1 hour
~Fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration daily
~Low-dose interferon-alpha 100,000 i.u. s.c. daily for the duration of the protocol"
16360103|NCT00178776|Behavioral|Transtheoretical Model Group Therapy|
16360104|NCT00178776|Behavioral|Education & Advice|
16360105|NCT00178763|Device|Heckel Infrared Radiant Heat Device|thermotherapy, maintain a core temperature of 40 degrees centigrade for 6 hours duration
16360106|NCT00178763|Other|cisplatin, gemcitabine, interferon-alpha|cisplatin 60 mg/m2 administered over 3 hours intravenously 36 hours before heat. gemcitabine 600 mg/m2 administered intravenously over 1 hour during 40 degree heat. interferon-alpha 1 million international units subcutaneously daily during protocol.
16360107|NCT00178763|Other|thermochemotherapy|fever-range whole-body thermal therapy to 40 degrees centigrade combined with cisplatin 60 mg/m2 + gemcitabine 600 mg/m2 + daily interferon alpha 1 million units.
16360108|NCT00178750|Device|18G Tuohy epidural needle|
16360109|NCT00178750|Device|CompuFlo® computerized syringe pump|
16360110|NCT00178737|Behavioral|Electronic reminder message|
16360111|NCT00178724|Other|No Treatment Given|Intervention is not given.
16360112|NCT00178711|Device|Hypothermia|Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
16360113|NCT00178698|Other|thermochemotherapy|cisplatin 60 mg/m2 i.v. over 4 hours on day 1 gemcitabine 600 mg/m2 i.v. over 60 minutes on day 3 interferon-alpha 1 million international units s.c. daily for protocol duration
16360114|NCT00178698|Drug|Cisplatin, Gemcitabine, Interferon-a|cisplatin 60 mg/m2 i.v. over 4 hours gemcitabine 600 mg/m2 i.v. over 1 hour interferon-alpha 100,000 i.u. s.c.daily fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration
16360115|NCT00178698|Other|thermochemotherapy|After hydration and anti-emetics, cisplatin 60 mg/m2 i.v. is given over 4 hours on day 1. Also on day 1, begin daily low-dose interferon-alpha 1 million international units s.c. On day 3, 36 hours after cisplatin infusion, induce fever-range whole-body thermal therapy to 40 oC (104 oF) for a duration of 6 hrs. When the target temperature of 40 oC is reached, gemcitabine 600 mg/m2 is administered i.v. over 60 minutes, and the temperature is maintained at plateau for a total of 6 hours. The cycle is repeated at 21 to 28 day intervals.
16360116|NCT00178685|Behavioral|Self-determination Intervention for Tobacco Dependence|autonomy supported behavioral intervention for tobacco dependent individuals
16360117|NCT00178672|Device|Angioguard XP distal protection device|Standard of care stenting of carotid arteries protocol is used.
16360118|NCT00178672|Procedure|Heart Catheterization -Angioplasty|Standard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area.
16360119|NCT00178672|Device|stenting|stenting of carotid arteries
16360120|NCT00178659|Other|Blood/saliva samples for protein/molecular analysis|Bloods samples - healthy volunteers(1 time) head injury subjects (5 times). Blood and/or saliva samples mild TBI patients (2 times) and healthy volunteers (2 times)
16360121|NCT00178646|Drug|Botox|Botox 75-150 units, single treatment only
16360122|NCT00178633|Procedure|Bariatric surgery|Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.
16360123|NCT00178620|Drug|Retavase 10 U IV Bolus|Retavase IV Bolus, 10 U, one dose at time of myocardial infarction
16360124|NCT00178620|Procedure|Angioplasty/Heart Catheterization|"Candidates will receive all the approved standard therapy for heart attacks patients and will go directly for emergent heart catheterization.
~Following local anesthesia, a small flexible tube (catheter) will be inserted in an artery of your leg and advanced to the arteries of your heart. By injecting x-ray contrast through the catheter, any blockage in the artery can be seen. If your heart attack artery is still blocked by blood clot or cholesterol deposits, it will be opened up by angioplasty (balloon surgery procedure to open the blocked artery) and stenting (placement of a slotted metal tube in the artery to prevent it from closing on itself)."
16360125|NCT00178620|Device|Drug eluting stent placed in heart attack related artery|Stents will be placed (if needed) during the end of the angioplasty/heart catheterization.
16360126|NCT00178581|Drug|Glutamine|
16360127|NCT00178568|Behavioral|Stress Management and Healthy Sleep Practices|Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.
16360128|NCT00178555|Device|DCI Video Intubation System-Macintosh Laryngoscope|
16360129|NCT00178555|Device|Macintosh Laryngoscope|
16360130|NCT00178529|Behavioral|Psychoeducation, Counseling and Skill Training|
16360131|NCT00178516|Other|behavior, procedure|
16360132|NCT00178503|Drug|Methylphenidate-extended release|Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.
16360133|NCT00178503|Drug|Methylphenidate-immediate release|Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.
16360134|NCT00178503|Other|Placebo|Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.
16360185|NCT00177970|Drug|Placebo|Placebo to be given IV to patients with C-Diff
16360186|NCT00177892|Procedure|sleep disruption|experimentally-induced Sleep Fragmentation
16360638|NCT00173615|Procedure|Extracorporeal membrane oxygenation|
16368403|NCT00108836|Drug|XBD173|
16360135|NCT00178490|Drug|High blood pressure treatment|Participants who are identified as having high blood pressure will be given by a pediatric nephrologist a 12-month treatment plan for their high blood pressure. The treatment plan will include a combination of diet, weight loss, increased exercise, and if needed, blood pressure medication. Participants receiving medication treatment will be treated with a calcium channel blocker and/or ACE inhibitor.
16360136|NCT00178477|Procedure|MRI with breath-holding|Breath holding for diminished tumor motion.
16360137|NCT00178464|Drug|aspirin|81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
16360138|NCT00178451|Drug|Abciximab|
16360139|NCT00178438|Device|Capsule Endoscopy|
16360140|NCT00178425|Procedure|Serial blood sampling as described in protocol|
16360141|NCT00178425|Procedure|Estimation of Creatinine Clearance at regular intervals|
16360142|NCT00178412|Behavioral|Care Project for Hospitalized Elders & Family Caregivers|"Phase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition)
~Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home"
16360143|NCT00178412|Behavioral|Comparison Group|"Phase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies.
~Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center."
16360144|NCT00178399|Procedure|Stereotactic Body Radiation Therapy|
16360145|NCT00178373|Drug|Modafinil|
16360146|NCT00178373|Drug|sugar pill|
16360147|NCT00178360|Behavioral|Music Therapy|"During individual Music Therapy sessions, subjects will participate in a variety of active music-making opportunities, including: playing musical instruments, singing, improvising, learning relaxation techniques, song writing, and/or lyric analysis. The activities for each session will be determined by both subject and therapist, and will be selected based on preference, emotional state, and desired goals for the day.
~Group music therapy sessions will focus on improving socialization, depression, and group dynamics. In this setting, the Music Therapist will choose from the following interventions:
~Group singing
~Group drumming
~Music assisted relaxation
~Group song writing
~Lyric analysis
~Improvisation
~Music with art"
16360148|NCT00178347|Radiation|Exposure to irradiation|Treatment for Cancer using Radiation -dose will be the standard of Care for the type of Cancer being treated
16360149|NCT00178321|Device|earplugs|
16360150|NCT00178295|Radiation|Radiation Therapy|standard of care for the cancer being treated
16360151|NCT00178282|Procedure|Pelvic Floor Muscle exercises|
16360152|NCT00178269|Drug|docetaxel|
16360153|NCT00178269|Procedure|Radiation Therapy|
16360154|NCT00178256|Drug|Paclitaxel|On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
16360155|NCT00178256|Procedure|Radiation Therapy|Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
16360156|NCT00178243|Procedure|3D Conformal Radiation Therapy and Radiosurgery|
16360157|NCT00178217|Behavioral|Music Therapy|The music therapy intervention will consist of approximately 30 minutes of active music making and/or improvisation. The session will begin at least 15 minutes prior to receiving the Botox injections, followed by the necessary time of the procedure and 10 minutes following. During this time the patient will be encouraged to actively engage in a musical activity of his/her choice. After the last injection has been administered, the monitoring and music therapy will continue for up to 10 minutes, and focus on soothing and relaxation rather than on distraction.
16360158|NCT00178191|Other|Bladder diary|3-day bladder diary
16360159|NCT00178191|Other|Questionnaires|Incontinence Quality of Life questionnaires
16360160|NCT00178191|Procedure|Urodynamics|Urodynamics
16360161|NCT00178191|Other|Pad weight|Pad weight
16360162|NCT00178178|Device|Breg Pain Care 3000 Catheter|Device: Breg Pain Care 3000 Catheter
16360163|NCT00178178|Drug|Bupivicaine 0.5%|Drug: Bupivicaine 0.5 %
16360164|NCT00178178|Drug|Placebo|Drug: Placebo
16360165|NCT00178165|Procedure|Skill Training Condition - problem solving training|
16360166|NCT00178165|Procedure|REACH for TLC (Telephone Linked Computer) system|
16360167|NCT00178139|Behavioral|Music Therapy|Music Therapy
16360168|NCT00178126|Device|Skin Protection Wheelchair Seat Cushion|Cushion receiving CMS code for Skin Protection Wheelchair Cushion
16360169|NCT00178126|Device|Segmented Foam Wheelchair Seat Cushion|General use class wheelchair seat cushion
16360170|NCT00178113|Drug|- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)|
16360171|NCT00178113|Drug|- Certagen (multivitamins with minerals)|
16360172|NCT00178100|Behavioral|Interpersonal Psychotherapy|
16360173|NCT00178100|Drug|paroxetine|
16360174|NCT00178074|Behavioral|total sleep deprivation|
16360175|NCT00178074|Procedure|PET imaging|
16360176|NCT00178061|Behavioral|Interpersonal Social Rhythm Therapy (IPSRT)|
16360177|NCT00178048|Drug|paroxetine|
16360178|NCT00178035|Drug|paroxetine|
16360179|NCT00178035|Behavioral|One night of Total Sleep Deprivation|
16360180|NCT00178022|Behavioral|Case management and problem solving therapy|
16360181|NCT00178009|Behavioral|self-paced instruction|Patients and caregivers review a DVD as often as they wish on how to care for routine and emergency procedures associated with their artificial heart
16360182|NCT00177996|Drug|sertraline hydrochloride|The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
16360183|NCT00177983|Behavioral|(relapse rate)|
16360184|NCT00177970|Drug|intravenous immunoglobulin G (IVIG)|IVIG to be given IV to patients with C-Diff .
16360187|NCT00177892|Procedure|sleep with and without positive pressure|OSAH patients with and without chronic positive airway pressure therapy
16360188|NCT00177879|Behavioral|website comparison|
16360189|NCT00177866|Drug|Celebrex|"Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
16360190|NCT00177866|Drug|placebo|placebo PO BID for either the first eight weeks or the last eight weeks of the study.
16360191|NCT00177853|Drug|celecoxib|Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.
16360192|NCT00177853|Drug|irinotecan|Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.
16360193|NCT00177853|Procedure|concurrent radiotherapy|50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.
16360194|NCT00177840|Procedure|acupuncture|
16360195|NCT00177775|Drug|MucoMilk product|
16360196|NCT00177762|Behavioral|behavior weight loss|
16360197|NCT00177749|Drug|Posaconazole|
16360198|NCT00177710|Drug|Amphotericin B|
16360199|NCT00177697|Behavioral|behavioral weight loss program|
16360200|NCT00177684|Drug|Amphotericin B|
16360201|NCT00177671|Drug|Escitalopram|Escitalopram, 10mg to 20mg daily.
16360202|NCT00177671|Drug|Donepezil|Donepezil, 5mg to 10mg daily.
16360203|NCT00177671|Drug|Venlafaxine|Venlafaxine, 150mg to 300mg daily.
16360204|NCT00177671|Drug|Placebo|
16360205|NCT00177671|Drug|Duloxetine|
16360206|NCT00177645|Procedure|sodium bicarbonate|inhalation of sodium bicarbonate or sodium chloride
16360207|NCT00177632|Behavioral|behavioral weight loss|
16360208|NCT00177619|Drug|Alendronate|
16360209|NCT00177606|Behavioral|withdrawal of life sustaining treatments|
16360210|NCT00177593|Behavioral|behavioral weight loss|
16360211|NCT00177580|Drug|Pravastatin|
16360212|NCT00177567|Drug|lithium carbonate|
16360213|NCT00177567|Drug|Depakote-ER|
16360214|NCT00177567|Drug|risperidone|
16360215|NCT00177567|Drug|olanzapine|
16360216|NCT00177567|Drug|paroxetine|
16360217|NCT00177567|Drug|bupropion|
16360218|NCT00177567|Drug|lamotrigine|
16360219|NCT00177567|Drug|venlafaxine|
16360220|NCT00177567|Drug|tranylcypromine|
16360221|NCT00177567|Drug|mirtazapine|
16360222|NCT00177554|Drug|Chemotherapy and Radioimmunotherapy|CHOP-R x 3 cycles followed by zevalin and extended rituximab
16360223|NCT00177541|Behavioral|Biofeedback, pelvic floor muscle training, fMRI|Biofeedback, pelvic floor muscle training, fMRI
16360224|NCT00177528|Drug|venlafaxine-XR|
16360225|NCT00177515|Behavioral|"video doctor, computer module"|computerized counseling about emergency contraception and peri-conception folate
16360226|NCT00177502|Behavioral|behavioral exercise intervention|
16360227|NCT00177489|Behavioral|multicomponent psychosocial intervention|The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
16360228|NCT00177489|Other|Control arm|"Caregivers in the control group received 2 brief check-in telephone calls during the 6-month intervention."
16360229|NCT00177476|Behavioral|behavioral weight loss|
16360230|NCT00177463|Drug|L-carnosine|an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
16360231|NCT00177437|Behavioral|home testing kit|
16360232|NCT00177424|Drug|sertraline|Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
16360233|NCT00177424|Drug|Placebo|matching placebo tablets
16360234|NCT00177411|Drug|Parathyroid Hormone-related Protein|Parathyroid Hormone-related Protein in doses started at a 4 microgram single bolus intravenous dose. Dose will be increase to a maximum of 400 micrograms or until a dose limiting toxicity occurs at a lower dose.
16360235|NCT00177398|Drug|Glargine insulin vs regular insulin|
16360236|NCT00177385|Behavioral|Modest sleep deprivation with sleep hygiene education|
16360237|NCT00177372|Drug|mifepristone/misoprostol|mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
16360238|NCT00177359|Behavioral|gait intervention|
16360239|NCT00177346|Device|CAS with cerebral protection|
16360240|NCT00177346|Device|CAS without cerebral protection|
16360241|NCT00177333|Drug|Doxycycline|
16360242|NCT00177307|Drug|Bevacizumab|Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
16360243|NCT00177307|Drug|Capecitabine|Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
16360244|NCT00177307|Drug|Oxaliplatin|Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
16360245|NCT00177294|Drug|Escitalopram|Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
16360246|NCT00177294|Behavioral|Interpersonal Psychotherapy|16 sessions of interpersonal psychotherapy (IPT)
16360247|NCT00177294|Behavioral|Clinical Monitoring|16 weeks of depression care management(DCM). No psychotherapy will be provided.
16360248|NCT00177281|Drug|S CKD602|
16360249|NCT00177268|Other|Blood draw, skin biopsy or urine collection|Up to 9 blood draws/year of 60 ml of whole blood. One 6 mm punch biopsy may be obtained up to 4 times per year.
16360250|NCT00177255|Drug|Docetaxel|"Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
~Cycle 2 will begin on day 22."
16360251|NCT00177255|Drug|Capecitabine|"Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
~Each cycle will consist of 21 days.
~Cycle 2 will begin on day 22."
16360252|NCT00177242|Drug|Gefitinib|
16360253|NCT00177229|Behavioral|Family-based treatment|20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.
16360254|NCT00177216|Drug|Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
16360255|NCT00177216|Drug|Escitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
16360256|NCT00177216|Drug|Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
16360257|NCT00177203|Behavioral|Brief Behavioral Treatment of Insomnia or Information|"The behavioral treatment involves education about sleep and its disorders; habits that help and hurt sleep; and recommendations about sleep hours and time in bed. It involves two meetings with a nurse who is part of the research team.
~In the information condition, participants are given similar information in printed brochures that are published by the American Academy of Sleep Medicine. They are instructed to read the information."
16360258|NCT00177177|Drug|L-carnosine (dietary supplement)|an antioxidant and AGE inhibitor, 500 mg/day, titration each week to reach 2000 mg/day in 4 weeks L-Carnosine is a dietary supplement
16360259|NCT00177164|Drug|Injectable Risperidone (Consta) or oral antipsychotic|"Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks
~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
16360260|NCT00177138|Drug|Tacrolimus|Starting POD #1 0.06 mg/kg/day in 2 divided doses;
16360261|NCT00177138|Drug|Alemtuzumab|30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)
16360262|NCT00177125|Device|ErectAid|
16360263|NCT00177112|Procedure|clean patient preparation for cystoscopy|
16360264|NCT00177112|Procedure|sterile patient preparation for cystoscopy|
16360265|NCT00177099|Drug|FK506, GP11046, GP11511|
16360266|NCT00177086|Other|Alfuzosin Hydrochloride|One tablet every day for 4 weeks
16360267|NCT00177060|Drug|hydromorphone|
16360268|NCT00177047|Procedure|Stem Cell Transplant|As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
16360269|NCT00177047|Drug|Cyclophosphamide + Mesna|Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
16360270|NCT00177047|Drug|Melphalan|Administered intravenously 200 mg/m^2
16360271|NCT00177047|Biological|Granulocyte-colony stimulating factor|Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
16360272|NCT00177034|Drug|Narrow Band UVB Treatment|
16360273|NCT00177021|Drug|Aldara Cream 5%|
16360274|NCT00177008|Drug|Aripiprazole|
16360275|NCT00176995|Drug|15% Eflornithine Hdyrochloride|
16360276|NCT00176982|Drug|Hydroxychloroquine|
16360277|NCT00176969|Drug|Capsaicin|
16360278|NCT00176956|Procedure|Skin Biopsy|Skin biopsy.
16360279|NCT00176943|Drug|Aldara Cream 5%|
16360280|NCT00176930|Biological|Stem Cell Transplant|Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
16360281|NCT00176930|Drug|Cyclophosphamide|60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
16360282|NCT00176930|Radiation|Total Body Irradiation|On Day -4, -3, -2, -1 total body irradiation is given twice daily.
16360283|NCT00176930|Drug|Busulfan|When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
16360284|NCT00176930|Drug|Equine ATG (ATGAM)|UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines
16360285|NCT00176930|Biological|CD4+/CD25+ cells|On days -2, patients will receive CD4+/CD25+ cells intravenously.
16360286|NCT00176917|Procedure|Stem Cell Transplant|The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains the enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e. blood taken from the umbilical cord after a baby is born and umbilical cord is cut).
16360287|NCT00176917|Drug|Busulfan, Cyclophosphamide, ATG|"Prior to transplantation, subjects will receive BUSULFAN intravenously (IV) via the Hickman line twice daily for 4 days, CYCLOPHOSPHAMIDE intravenously via the Hickman line once a day for 4 days, and ANTI-THYMOCYTE GLOBULIN IV via the Hickman line twice daily for three days before the transplant. These three drugs are being given to help the new marrow take and grow. METHYLPREDNISOLONE will be given as a pre-medication for the ATG."
16360639|NCT00173550|Procedure|Hysterectomy and Bilateral salpingo-oophorectomy|
16360288|NCT00176904|Procedure|Stem Cell Transplant|The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains an enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e., blood taken from the umbilical cord after a baby is born and umbilical cord is cut).
16360289|NCT00176904|Drug|Busulfan, Cyclophosphamide, Antithymocyte Globulin|"Subjects will receive BUSULFAN intravenously (IV)- patients < or= 12 kg 1.1 mg/kd/dose IV every 6 hours for 16 doses; patients > 12kg 0.8 mg/kg/dose IV every 6 hours for 16 doses - via the Hickman line four times daily for 4 days, CYCLOPHOSPHAMIDE intravenously (50 mg/kg/day IV over 2 hours) via the Hickman line once a day for 4 days, and ANTI-THYMOCYTE GLOBULIN IV (15 mg/kg/day over 2 hours) via the Hickman line twice daily for three days before the transplant. These three drugs are being given to help the new marrow take and grow. METHYLPREDNISOLONE will be given as a pre-medication for the ATG."
16360290|NCT00176891|Procedure|Stem Cell Transplant|enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following
16360291|NCT00176891|Drug|Laronidase ERT|Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following.
16360292|NCT00176878|Procedure|Stem cell transplant|Stem cell transplant on Day 0 - healthy marrow from an unrelated individual. A minimum of 1.0 x 10^9/kg nucleated cells/kg ideal body weight will be collected with a goal of 2.0 x 10^9/kg.
16360293|NCT00176878|Drug|Fludarabine monophosphate|fludarabine 175 mg/m^2 (total) on Days -6 through -3.
16360294|NCT00176878|Procedure|Total lymphoid irradiation|Dose 500 cGy radiation therapy to specific areas of the body
16360295|NCT00176878|Drug|Busulfan|Busulfan 8 mg/kg (total) on Days - 8 and -7 (orally or through the catheter),
16360296|NCT00176878|Biological|anti-thymocyte globulin|anti-thymocyte globulin (ATG) 15 mg/kg on days -2 and -1 via catheter
16360297|NCT00176865|Procedure|Stem Cell Transplant|IV on Day 0
16360298|NCT00176865|Drug|Fludarabine|30mg/m^2 IV Day -7 through Day -3
16360299|NCT00176865|Drug|Melphalan|140 mg/m^2 IV Day -1
16360300|NCT00176865|Drug|Anti-thymocyte globulin (ATG)|30 mg/kg IV Day -5 through Day -1
16360301|NCT00176865|Drug|Campath 1H|0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6
16360302|NCT00176865|Drug|Cyclosporin A|2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children <40 kg) maintaining a level of >200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181
16360303|NCT00176865|Drug|Mycophenolate mofetil|15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present
16360304|NCT00176865|Drug|Intravenous immunoglobulin (IVIG)|500 mg/kg IV weekly beginning on Day +7 until Day +100
16360305|NCT00176852|Drug|Busulfan, Fludarabine, ATG, TLI|Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy
16360306|NCT00176852|Drug|Busulfan, Cyclophosphamide, ATG, GCSF|Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.
16360307|NCT00176852|Drug|Campath, Fludarabine, Cyclophosphamide|Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.
16360308|NCT00176852|Radiation|Total Body Irradiation|300 cGY Day -1
16360309|NCT00176852|Procedure|Stem cell infusion|Given Day 0
16360310|NCT00176839|Procedure|Stem Cell Transplant|Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
16360311|NCT00176839|Drug|Busulfan|Prior to transplantation, subjects will receive BUSULFAN via the central venous line, four times a day for four days (days -7 through -4).
16360312|NCT00176839|Drug|Cyclophosphamide|Prior to stem cell transplantation, subjects will receive CYCLOPHOSPHAMIDE via the central venous line once a day for two days on days -3 and -2.
16360313|NCT00176839|Drug|Melphalan|MELPHALAN will be given via the central venous line for one day, on day -1, prior to stem cell transplantation.
16360314|NCT00176839|Drug|G-CSF|G-CSF is to be given daily IV beginning on day +1 until ANC 2.5 x 109/L.
16360315|NCT00176839|Drug|ATG|ATG will be administered to umbilical cord blood recipients.
16360316|NCT00176826|Procedure|Stem Cell Transplant|Infusion of hematopoietic stem cells (bone marrow, cord blood, peripheral blood stem cells) following myeloablative conditioning regimen.
16360317|NCT00176826|Drug|Myeloablative conditioning regimen|Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
16360318|NCT00176813|Drug|Gemcitabine|
16360319|NCT00176813|Drug|Cisplatin|
16360320|NCT00176813|Drug|Celecoxib|
16360321|NCT00176800|Drug|Tetrathiomolybdate (TM)|Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
16360322|NCT00176800|Procedure|Radiation|Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
16360323|NCT00176800|Procedure|Surgery|The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
16360324|NCT00176787|Drug|Capecitabine|
16360325|NCT00176787|Procedure|Radiation|
16360326|NCT00176787|Procedure|Surgery|
16360327|NCT00176774|Drug|Irinotecan|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
16360328|NCT00176774|Drug|5-Fluorouracil|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
16360640|NCT00173537|Procedure|for BMPR II study|
16360329|NCT00176774|Drug|Leucovorin|Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
16360330|NCT00176774|Drug|Tetrathiomolybdate|one 40 mg oral (by mouth) dose of TM three times a day with meals and one 60 mg oral dose (without food) at bedtime beginning at bedtime on day 1 of your first 6-week cycle of treatment. The between meal dose must be taken at least one hour before or one hour after a meal.
16360331|NCT00176761|Drug|Interleukin-2 (IL-2)|
16360332|NCT00176748|Drug|AG 6013736|5 mg po bid
16360333|NCT00176735|Drug|Capecitabine|
16360334|NCT00176722|Other|table tilt|One group randomized to table tilt. One group will be flat.
16360335|NCT00176696|Device|Use of FACE monitor and BIS monitor|Face monitor records facial muscle activity
16360336|NCT00176683|Procedure|Capnography|device which measures carbon dioxide at intubation
16360337|NCT00176670|Drug|midazolam or GameBoy or parental presence|
16360338|NCT00176657|Drug|HEMOBAG Assessment|
16360339|NCT00176644|Drug|Transdermal Estradiol|"application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
16360340|NCT00176631|Dietary Supplement|licorice root extract|Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
16360341|NCT00176631|Drug|docetaxel|All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
16360342|NCT00176618|Drug|sulindac|Sulindac 150 mg po BID
16360343|NCT00176618|Drug|curcumin|Curcumin 250 mg po BID
16360344|NCT00176605|Drug|Etoposide|50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide.
16360345|NCT00176605|Drug|Cyclophosphamide|50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated
16360346|NCT00176592|Drug|Betaseron|Betaseron 250 micrograms injected SQ every other day
16360347|NCT00176592|Drug|Copaxone|Copaxone 20 mg injected SQ every day (glatiramer acetate)
16360348|NCT00176579|Procedure|dual x-ray absorptiometry|Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
16360349|NCT00176566|Drug|Lozenge Intake|of green tea lozenges weighing 6 grams each, containing 0.45 grams of green tea solids eight (8) times daily for 12 weeks to patients with oral leukoplakia compared to the administration of a lozenge that does not contain green tea (i.e. a placebo lozenge).
16360350|NCT00176553|Drug|Dextromethorphan|Patients will receive an inert carrier with or without dextromethorphan. The study drug will be administered at 1.5 mg/kg/dose on a BID schedule. The first dose to be given prior to each scheduled intravenous and/or intrathecal administration of methotrexate and continued for a total of seven days.
16360351|NCT00176540|Drug|dextromethorphan hydrobromide|
16360352|NCT00176527|Biological|recombinant interferon alfa-2b|
16360353|NCT00176527|Drug|docetaxel|
16360354|NCT00176527|Drug|estramustine phosphate sodium|
16360355|NCT00176527|Drug|isotretinoin|
16360356|NCT00176527|Genetic|polyacrylamide gel electrophoresis|
16360357|NCT00176527|Genetic|protein expression analysis|
16360358|NCT00176527|Other|immunohistochemistry staining method|
16360359|NCT00176514|Drug|Administration of the antineoplastic|
16360360|NCT00176501|Biological|therapeutic allogeneic lymphocytes|If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
16360361|NCT00176488|Drug|epirubicin|Epirubicin (100 mg/m2) will be given on Day 1
16360362|NCT00176488|Drug|vinorelbine|Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
16360363|NCT00176475|Biological|rituximab|Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).
16360364|NCT00176475|Biological|therapeutic allogeneic lymphocytes|The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures
16360365|NCT00176462|Drug|aminopterin|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360366|NCT00176462|Drug|L-asparaginase|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360367|NCT00176462|Drug|cyclophosphamide|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360368|NCT00176462|Drug|cytarabine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360369|NCT00176462|Drug|daunomycin|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360641|NCT00173537|Genetic|BMPRII|
16360642|NCT00173524|Behavioral|PharmacoEconomic Assessment|Collecting PE data.
16368404|NCT00108823|Drug|Roflumilast|
16360370|NCT00176462|Drug|dexamethasone|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360371|NCT00176462|Drug|6-mercaptopurine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360372|NCT00176462|Drug|methotrexate|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360373|NCT00176462|Drug|6-thioguanine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360374|NCT00176462|Drug|vincristine|Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
16360375|NCT00176462|Drug|Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)|
16360376|NCT00176462|Drug|Leucovorin|
16360377|NCT00176449|Drug|Bupropion SR|150mg twice a day (starting with 150mg once a day for three days)
16360378|NCT00176449|Drug|Placebo Oral Tablet|Comparable placebo
16360379|NCT00176436|Behavioral|Diet support group|Diet support group weekly and exercise sessions 3 times/week, placebo medication
16360380|NCT00176436|Behavioral|Group counseling and exercise|Support group weekly and exercise sessions 3 times/week for 24 weeks
16360381|NCT00176423|Drug|galantamine|see arm/group description
16360382|NCT00176410|Drug|fluvastatin|40mg fluvastatin daily
16360383|NCT00176397|Procedure|Percutaneous coronary intervention (left main)|
16360384|NCT00176384|Behavioral|Aerobic endurance exercise training (ergometer)|
16360385|NCT00176371|Behavioral|physical exercise|
16360386|NCT00176358|Device|PTCA and Stent Implantation|
16360387|NCT00176358|Behavioral|Exercise Training|
16360388|NCT00176345|Behavioral|Exercise Training|
16360389|NCT00176332|Drug|rosuvastatin|
16360390|NCT00176319|Behavioral|Aerobic endurance exercise training (ergometer)|
16360391|NCT00176306|Drug|Levofloxacin 750 mg IV|PK in obesity
16360392|NCT00176293|Drug|dexamethasone|oral dexamethasone, 12mg BID on days 1, 2, 3, 4, & 5 of each 28-day cycle
16360393|NCT00176293|Drug|doxorubicin|Doxorubicin 50mg/m^2 I.V. on day 5
16360394|NCT00176280|Drug|Leukine|
16360395|NCT00176280|Drug|Dexamethasone|
16360396|NCT00176267|Radiation|Radiotherapy|50 cGy on days 1, 2, 8, 15, 22, 23, 29 & 36 of chemotherapy
16360397|NCT00176267|Drug|Paclitaxel|75 mg/m2 intravenously over one hour on Days 1, 8, 15, 22, 29 and 36
16360398|NCT00176267|Drug|Carboplatin|AUC of 6 on Days 1 & 22
16360399|NCT00176254|Radiation|Radiotherapy|80 centigray (cGy) on Day 1 & 2 and 22 & 23 of chemotherapy
16360400|NCT00176254|Drug|Paclitaxel|225 mg/m2 intravenously over three hours on Days 1 and 22
16360401|NCT00176254|Drug|Carboplatin|Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22
16360402|NCT00176241|Drug|gemcitabine|2000-3000mg/m2 IV on days 1 & 15
16360403|NCT00176241|Drug|paclitaxel|150 mg/m2 IV on days 1 & 15
16360404|NCT00176241|Radiation|radiation|50-80 cGy on days 1,2,15,16
16360405|NCT00176228|Drug|Lamotrigine|"It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents.
~The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg."
16360406|NCT00176215|Procedure|survival failure of more than 20 %|
16360407|NCT00176202|Drug|Divalproex Sodium|Divalproex sodium is a mood stabilizer
16360408|NCT00176202|Drug|risperidone|Risperidone is a second generation antipsychotic and antimanic drug
16360409|NCT00176189|Device|All ceramic FPDs|
16360410|NCT00176176|Device|EEG|
16360411|NCT00176163|Behavioral|Operant behavioral treatment; Drug: THC|
16360412|NCT00176137|Procedure|preoperative radiochemotherapy|
16360413|NCT00176124|Procedure|leukocyte depletion of whole blood|
16360414|NCT00176124|Other|Leukocyte filtration/Depletion|leukocyte depletion filters as used routinely: filters (prestorage) inherent to the blood bag sets by gravity force following storage on cold plate for 2 hours
16360415|NCT00176111|Procedure|peripheral nerve stimulation (procedure)|
16360416|NCT00176098|Procedure|Hypnoanalgesia; Hypnotic shielding|
16360417|NCT00176059|Drug|intravenous immunoglobulins (IVIG)|
16360418|NCT00176059|Procedure|kidney transplantation|
16360419|NCT00176046|Drug|viscum album pini|s.c. injection of 0,001-20 mg 3 times per week
16360420|NCT00176046|Drug|viscum album pini|s.c. injection 0,001-20 mg 3 times per week
16360421|NCT00176020|Drug|nicotinic acid|
16360422|NCT00176007|Procedure|Hypoxia|
16360423|NCT00175981|Drug|sildenafil, fluvoxamine|
16360424|NCT00175968|Procedure|bed rest, hypocaloric nutrition|
16360425|NCT00175955|Drug|Levetiracetam|
16360426|NCT00175929|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
16360427|NCT00175929|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
16360428|NCT00175929|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
16360643|NCT00173511|Device|24 hr Holter monitor|
16360644|NCT00173472|Drug|Chemotherapy|
16368620|NCT00107315|Biological|bevacizumab|
16360429|NCT00175916|Drug|Brivaracetam (ucb 34714)|10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
16360430|NCT00175903|Drug|Levetiracetam|Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
16360431|NCT00175903|Drug|Carbamazepine Controlled Release (CBZ-CR)|Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
16360432|NCT00175903|Drug|Valproate Extended Release|Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
16360433|NCT00175890|Drug|Levetiracetam|Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
16360434|NCT00175890|Other|Placebo|Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
16360435|NCT00175877|Biological|Certolizumab Pegol|"Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
~Duration: Until end of study."
16360436|NCT00175864|Drug|Seletracetam (ucb 44212)|
16360437|NCT00175851|Drug|Seletracetam (ucb 44212)|
16360438|NCT00175838|Drug|Hydroxyurea|Hydroxyurea (or hydroxycarbamide) is an antineoplastic drug commonly used to treat haematological malignancies.
16360439|NCT00175838|Drug|Aspirin|Aspirin is an anti-aggregating agent, and has been shown to reduce/alleviate minor ischaemic symptoms.
16360440|NCT00175825|Other|Placebo|Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
16360441|NCT00175825|Drug|Brivaracetam|Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
16360442|NCT00175812|Drug|all-trans retinoic acid (ATRA)|All-trans retinoic acid 22.5 mg/square meter twice daily days 1-14
16360443|NCT00175812|Drug|Valproic acid|Valproic acid, highest dose without side effects from day 3 until progression
16360444|NCT00175812|Drug|Theophyllin|Theophyllin, targetted serum level 50-100 from day 3 until progression
16360445|NCT00175760|Procedure|Diagnosis of Celiac Disease|During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
16360446|NCT00175747|Drug|Inhaled Budesonide 800 µg twice daily|
16360447|NCT00175734|Procedure|High Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
16360448|NCT00175734|Procedure|Low Hemoglobin Concentration|The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
16360449|NCT00175721|Procedure|The Combined Cardiac Kidney Diabetes Care Clinic|See Detailed Description.
16360450|NCT00175695|Drug|Recombinant human activated protein C or drotrecogin alpha|We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders.
16360451|NCT00175682|Drug|Prazosin HCL|See Detailed Description
16360452|NCT00175669|Drug|Botox injections|Data not known.
16360453|NCT00175656|Procedure|Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ|See Detailed Description.
16360454|NCT00175643|Drug|imiquimod|
16360455|NCT00175630|Procedure|Administration of a femoral nerve block (bupivacaine HCL)|See Detailed Description
16360456|NCT00175617|Drug|Spironolactone|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
16360457|NCT00175617|Drug|Minoxidil|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
16360458|NCT00175604|Drug|Botox|The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox.
16360459|NCT00175591|Procedure|Administration of a femoral nerve block (bupivacaine HCL)|No details specified
16360460|NCT00175565|Drug|inhaled fluticasone 500 mcg b.i.d.|
16360461|NCT00175552|Behavioral|Psychotherapy Training|
16360462|NCT00175539|Behavioral|psychoeducational intervention|three 1.5 hour long group psychoeducational sessions
16360463|NCT00175526|Behavioral|preeclampsia|This research project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is specific to the condition. To develop and validate the tool w
16360464|NCT00175513|Drug|Valacyclovir (Valtrex)|
16360465|NCT00175500|Device|Large Diameter Femoral Head|
16360466|NCT00175487|Procedure|Hip replacement|This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
16360467|NCT00175474|Procedure|knee surgery|
16360468|NCT00175461|Procedure|hip surgery|Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty
16360469|NCT00175448|Procedure|physiotherapy|See Detailed Description.
16360470|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
16360471|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
16360472|NCT00175435|Biological|Resiquimod gel|3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
16360565|NCT00174655|Drug|Doxorubicine + docetaxel sequential|doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
16360473|NCT00175422|Behavioral|The Period of PURPLE Crying Program|There are two treatment arms in the study. The first half of all subjects (n=500) will receive the PURPLE intervention materials (a video and a pamphlet) about infant crying. The second arm will receive comparable materials on infant safety and SIDS.
16360474|NCT00175409|Procedure|Blood collection|For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
16360475|NCT00175409|Procedure|Blood collection|For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
16360476|NCT00175396|Procedure|Androgen suppression, radiotherapy|Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by an external beam radiation boost lasting 3.2-4 weeks (32 Gy in 16 equal fractions).
16360477|NCT00175396|Procedure|Androgen suppression, radiotherapy, iodine 125 brachytherapy|Total of 12 months of androgen suppression. 8 months after the start of androgen suppression 4.2-5 weeks external beam radiation (46 Gy in 23 equal fractions) followed by iodine 125 brachytherapy carried out 14-25 days after the last external beam treatment.
16360478|NCT00175383|Drug|luteinizing hormone-releasing hormone (LHRH) short acting or long acting|See Detailed Description.
16360479|NCT00175370|Drug|Vancomycin|Randomized double-blind equivalence trial to test the hypothesis that 2 days is equivalent to 7 days of vancomycin treatment for intravascular device associated bacteremia due to coagulase negative staphylococcus. The definitions for the surveillance of intravascular device associated bacteremia from the Laboratory Centre for Disease Control-Health Canada will be used. Surveillance blood cultures on days 4 and 9 following removal of intravascular device. Relatedness of strains will be determined by pulsed-field gel electrophoresis (PFGE).
16360480|NCT00175357|Drug|Methadone|The dose of the drug will be determined by a physician. The oral drug will be administered 1 dose per days, 7 days per week.
16360481|NCT00175357|Drug|Diamorphine hydrochloride|The dose of the drug will be determined by a physician. The injected drug will be administered up to 3 doses per day, 7 days per week.
16360482|NCT00175344|Procedure|Scar massage.|To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars.
16360483|NCT00175318|Behavioral|Motivational Interviewing|Beginning at 12 months of age, regular application of fluoride varnish will be an option that a mother in the MI group may choose for her child. Control families will receive dental health information from a pamphlet, and will have access to fluoride varnish at local dental clinics.
16360484|NCT00175305|Drug|Sandostatin LAR|
16360485|NCT00175292|Drug|Probiotic - VSL#3|
16360486|NCT00175279|Behavioral|Opinion leader generated and endorsed evidence summaries|
16360487|NCT00175266|Drug|alemtuzumab|
16360488|NCT00175266|Procedure|islet transplant|
16360489|NCT00175266|Drug|infliximab|
16360490|NCT00175253|Drug|alemtuzumab|
16360491|NCT00175253|Procedure|islet transplant|
16360492|NCT00175240|Behavioral|Evidence summaries endorsed by local opinion leaders|
16360493|NCT00175227|Drug|intravenous saline hydration + mannitol + furosemide|500 mls half-normal saline + 25g mannitol + 100 mg furosemide
16360494|NCT00175227|Drug|intravenous saline hydration|500 mls half-normal saline
16360495|NCT00175214|Behavioral|Multifaceted intervention (patient education, physician guidelines, reminders)|
16360496|NCT00175201|Procedure|Proactive care and rehabilitation|
16360497|NCT00175188|Device|Avanta (PIP joint implant with a titanium porous coating)|Implant is inserted at the time of surgery, after written consent
16360498|NCT00175175|Behavioral|"Allied health professional-run osteoporosis service (case-management)"|
16360499|NCT00175162|Device|Osteopal G vs. Refobacin-Palacos R bone cement|Bone cement
16360500|NCT00175149|Drug|Alfacalcidiol|Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.
16360501|NCT00175136|Device|Maxim TKA|Operation with Total Knee Arthroplasty and either an I-beam stem or a wedge stem of the tibial component.
16360502|NCT00175123|Drug|Botulinum A toxin|Intravesical injection. 12 IE/kg b.w.
16360503|NCT00175110|Behavioral|herbal therapy/botanical therapy (Hibiscus sabdariffa)|
16360504|NCT00175097|Other|Diet: soybeans and products made thereof|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.
16360505|NCT00175097|Other|Diet: soybean flour and products made thereof|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.
16360506|NCT00175097|Other|Diet: soybean milk|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.
16360507|NCT00175097|Other|Diet: Animal protein based diet|The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.
16360508|NCT00175084|Behavioral|Comparison of dietary protein amino acid profile|Healthy adults over 50 years of age (men and postmenopausal women) will be assigned to one of two diets differing in lysine to arginine ration (0.7 vs. 1.4) for a 5 week period and then switched to the alternate diet, with a 2 to 4-week washout period, in a randomized crossover design. Blood samples will be collected three times in the fasted state and once 4-hours after the evening meal during the last week of each dietary period of measurement of concentration of plasma lipids, lipoproteins, apolipoproteins, arginine, C-reactive protein, nitrites/nitrates, homocysteine, lecithin-cholesterol acetyltransferase (LCAT), cholesteryl ester transfer protein (CETP), and LDL-receptor messenger ribonucleic acid (mRNA) expression.A 24-hour urine sample will be collected at the end of each phase to measure F2-isoprostanes as an indicator of whole body oxidation.
16360509|NCT00175071|Behavioral|Comparison of cooking oils|30 subjects will consume each of the two diets in randomized order for 5 weeks each. Diets will be designed to maintain body weight; will have 30% of energy as fat which 2/3 or 20% of energy will be either the conventional or reformulated fat. Blood lipids and C reactive protein (CRP) as well as indicators of how lipids are processed in the blood will be measured at the end of each dietary phase.
16360510|NCT00175058|Device|AO Therapy (aqueous oxygen)|90-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting
16360511|NCT00175045|Drug|Lansoprazole|Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
16360512|NCT00175045|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.
16360513|NCT00175032|Drug|Lansoprazole and naproxen and aspirin|Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
16360514|NCT00175032|Drug|Celecoxib and aspirin|Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
16360515|NCT00175019|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily.
16360516|NCT00175019|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily.
16360517|NCT00175019|Drug|Allopurinol|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
16360518|NCT00175006|Other|Measurement of Tophi to validate procedure|Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.
16360519|NCT00174993|Drug|Pioglitazone|Pioglitazone 15 mg to 45 mg, tablets, orally, once daily for up to 48 months.
16360520|NCT00174993|Drug|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 48 months
16360521|NCT00174980|Drug|perfluorocarbon emulsion (Oxycyte) infusion|one time dose of 3mL/kg over 15 minutes
16360522|NCT00174967|Drug|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
16360523|NCT00174967|Drug|Febuxostat|Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
16360524|NCT00174967|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
16360525|NCT00174967|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
16360526|NCT00174954|Procedure|MRI|Subjects underwent MRI to evaluate tophi.
16360527|NCT00174941|Drug|Febuxostat|Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
16360528|NCT00174941|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
16360529|NCT00174941|Drug|Febuxostat|Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
16360530|NCT00174928|Drug|Lansoprazole|Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
16360531|NCT00174928|Drug|Lansoprazole|Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
16360532|NCT00174915|Drug|Febuxostat|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
16360533|NCT00174915|Drug|Febuxostat|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
16360534|NCT00174915|Drug|Febuxostat|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
16360535|NCT00174915|Drug|Allopurinol|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
16360536|NCT00174915|Drug|Placebo|Placebo, orally, once daily for up to 28 weeks.
16360537|NCT00174902|Drug|inderal (drug), acetylsalicylic acid (drug)|
16360538|NCT00174889|Drug|Pregnenolone|
16360539|NCT00174876|Drug|Drug Abilify|
16360540|NCT00174863|Drug|SR31747A|
16360541|NCT00174850|Drug|Gaitril|
16360542|NCT00174837|Drug|Tirapazamine|in combination with cisplatin and concomitant radiation
16360543|NCT00174837|Drug|Cisplatin|with concomitant radiation
16360544|NCT00174824|Drug|Insulin glargine|
16360545|NCT00174811|Drug|telithromycin (HMR3647)|
16360546|NCT00174798|Drug|SSR240600C|once daily
16360547|NCT00174798|Drug|Placebo|oral
16360548|NCT00174798|Drug|Tolterodine|once daily
16360549|NCT00174785|Drug|dronedarone (SR33589)|oral administration (tablets)
16360550|NCT00174785|Drug|placebo|oral administration (tablets)
16360551|NCT00174772|Drug|docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy|docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy
16360552|NCT00174772|Drug|docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin|docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
16360553|NCT00174759|Drug|Clopidogrel|
16360554|NCT00174746|Drug|AVE2635A|
16360555|NCT00174733|Drug|Ciclesonide (XRP1526)|
16360556|NCT00174720|Drug|Ciclesonide (XRP1526)|
16360557|NCT00174707|Drug|epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile|Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
16360558|NCT00174707|Drug|epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile|Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
16360559|NCT00174707|Drug|epidoxorubicine, docetaxel, cyclophosphamide|Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
16360560|NCT00174694|Drug|Telithromycin|
16360561|NCT00174681|Drug|Insulin Glargine|
16360562|NCT00174668|Drug|Insulin Glulisine|insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal
16360563|NCT00174668|Drug|Insulin Therapy|NPH (70%) plus regular insulin or insulin aspart (30%)
16360564|NCT00174668|Drug|Insulin Glargine|1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
16360635|NCT00173654|Procedure|blood drawing|
16360636|NCT00173641|Procedure|blood drawing|
16360566|NCT00174655|Drug|doxorubicine + cyclophosphamide sequential|doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
16360567|NCT00174655|Drug|doxorubicine + cyclophosphamide combined|doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
16360568|NCT00174655|Drug|doxorubicine + docetaxel combined|doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
16360569|NCT00174642|Drug|Insulin Glargine|One daily injection in the evening. 100 U/ml
16360570|NCT00174642|Drug|Insulin Glulisine|Given immediately before each of the three main meals. 100 U/ml
16360571|NCT00174642|Drug|Metformin|At same dosages as the previous treatment
16360572|NCT00174642|Drug|insulin secretagogue|sulfonylurea or glinide
16360573|NCT00174629|Drug|Docetaxel/DDP|
16360574|NCT00174629|Drug|docetaxel/gemcitabine|
16360575|NCT00174616|Drug|Oxaliplatin, capecitabine, radiotherapy|"Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses
~Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks
~Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks"
16360576|NCT00174603|Drug|quetiapine|
16360577|NCT00174590|Drug|risperidone|
16360578|NCT00174577|Drug|Risperidone|
16360579|NCT00174564|Drug|oxaliplatin|
16360580|NCT00174551|Drug|prazosin|
16360581|NCT00174538|Drug|Codeine (30 mg)|
16360582|NCT00174525|Drug|AAB-001|
16360583|NCT00174512|Drug|GTN|
16360584|NCT00174512|Drug|Moxifloxacin|
16360585|NCT00174499|Drug|2 mg nicotine gum|2 mg nicotine gum
16360586|NCT00174499|Drug|4 mg nicotine gum|4 mg nicotine gum
16360587|NCT00174486|Drug|UK0369,003|
16360588|NCT00174486|Drug|Cialis (Tadalafil)|
16360589|NCT00174473|Drug|Voriconazole|
16360590|NCT00174460|Drug|Somatropin|Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.
16360591|NCT00174460|Other|Control Arm|Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.
16360592|NCT00174447|Drug|Ziprasidone|Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid
16360593|NCT00174434|Drug|SU011248|SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
16360594|NCT00174434|Drug|Paclitaxel|Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.
16360595|NCT00174421|Drug|Treatment with Genotropin in different dosages|
16360596|NCT00174408|Drug|Genotropin|
16360597|NCT00174395|Drug|eletriptan|
16360598|NCT00174382|Drug|Donepezil|donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
16360599|NCT00174369|Drug|PD-0325901|15 mg BID
16360600|NCT00174356|Drug|CI 1033|
16360601|NCT00174356|Drug|PACLITAXEL|
16360602|NCT00174356|Drug|CARBOPLATIN|
16360603|NCT00174343|Drug|exemestane (Aromasin®)|
16360604|NCT00174330|Drug|atorvastatin|
16360605|NCT00174330|Drug|amlodipine|
16360606|NCT00174317|Drug|Celecoxib|
16360607|NCT00174317|Drug|Diclofenac|
16360608|NCT00174304|Drug|Amlodipine/atorvastatin single pill|
16360609|NCT00174291|Drug|Somatropin|Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
16360610|NCT00174278|Drug|Somatropin|
16360611|NCT00174265|Drug|asenapine|5-10 mg sublingually twice daily for 26 weeks
16360612|NCT00174265|Drug|olanzapine|5-20 mg by mouth once daily for 26 weeks
16360613|NCT00174252|Drug|Genotonorm (Somatropin)|0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
16360614|NCT00174239|Drug|cabergoline|
16360615|NCT00174239|Drug|controlled-release levodopa / carbidopa|
16360616|NCT00174226|Drug|Atomoxetine|
16360617|NCT00174226|Drug|Buspirone|
16360618|NCT00174200|Drug|Risperidone 2 mg|
16360619|NCT00174187|Drug|Somatropin|liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day
16360620|NCT00174174|Drug|Modafinil|
16360621|NCT00174161|Behavioral|self-care, health behavior|
16360622|NCT00173992|Behavioral|Balance and Exercise|
16360623|NCT00173953|Procedure|immune response|
16360624|NCT00173901|Drug|ceftazidime|
16360625|NCT00173888|Drug|Docetaxel, Cisplatin|docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
16360626|NCT00173888|Drug|Gemcitabine, Cisplatin|gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
16360627|NCT00173875|Drug|Iressa|
16360628|NCT00173862|Drug|Gemcitabine, Ifosfamide|
16360629|NCT00173758|Procedure|co-culture of embryos and endometrial cells|
16360630|NCT00173745|Drug|botulinum toxin A injection|
16360631|NCT00173719|Device|Standard cane|
16360632|NCT00173706|Drug|L-Carnitine Injection|
16360633|NCT00173693|Behavioral|exercise for strength, balance, health education|
16360634|NCT00173667|Drug|Nifedipine 30 mg GITS|
16360645|NCT00173407|Procedure|immunohistochemical, methylation, gene transfection|
16360646|NCT00173251|Procedure|obtain surgical specimen for analysis|
16360647|NCT00173108|Behavioral|clinic-based intervention program and home-based intervention program|The intervention includes education of child development skills, health and feeding consultation, intervention of mother-infant interaction, and parent support. Clinic-based intervention program is delivered in clinic while home-based intervention program is delivered at home.
16360648|NCT00173082|Procedure|Glucose tolerance test|
16360649|NCT00173017|Device|wearing N95 masks|
16360650|NCT00172939|Procedure|foreskin from healthy adults|
16360651|NCT00172809|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 135 ug/week for 24 weeks
16360652|NCT00172809|Drug|Interferon alfa-2a|Interferon alfa-2a 3 MU tiw for 24 weeks
16360653|NCT00172653|Procedure|functional tasks|
16360654|NCT00172601|Procedure|mobilization|
16360655|NCT00172536|Behavioral|Exercise training|Subjects attended a supervised treadmill training session three times per week in an outpatient facility for three months. Training duration was 30 minutes per session, including a 5-minute warm-up and cool-down phase. Training intensity was initially set at about 60% of HR reserve and close to the anerobic threshold (AT) and the gradually increased as tolerated.
16360656|NCT00172536|Other|Control|Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.
16360657|NCT00172510|Procedure|blood drawing|
16360658|NCT00172484|Procedure|education program|A well-designed questionnaire concerning about awareness of stroke symptoms, knowledge, and management was done in adults of stroke victims' family members and general population.
16360659|NCT00172484|Procedure|nursing program|To establish a systemic stroke prevention, education protocol
16360660|NCT00172484|Procedure|rehabilitation program|From a sample of 648 stroke patients who were referred to rehabilitation between November 2002 and October 2002, 345 charts were successfully reviewed. Besides, 126 subjects were randomly selected and successfully contacted for telephone follow-up; and data from 87 subjects of telephone survey were included for statistical analysis. Comparison of functional status between early rehabilitation and ordinary scheduled rehabilitation for acute stroke patients was done from admission to 3 months after stroke onset. The efficacy of early application of electric stimulation for the upper paralyzed extremity was performed.
16360661|NCT00172445|Procedure|blood sampling, neck lymph node biopsy|
16360662|NCT00172419|Drug|Atorvastatin|Atorvastatin, 40 mg/day for 12 weeks
16360663|NCT00172380|Drug|Docetaxel Plus CDDP|docetaxel 36mg/m2 and cisplatin 75mg/m2
16360664|NCT00172367|Drug|Lycopene|
16360665|NCT00172354|Drug|Hydrocortisone|
16360666|NCT00172341|Drug|Staloral TM|
16360667|NCT00172328|Biological|Hepatitis B vaccine|
16360668|NCT00172302|Drug|vitamin C, intravenous injection|
16360669|NCT00172263|Procedure|blood sampling|
16360670|NCT00172211|Drug|Physioneal|
16360671|NCT00172198|Drug|Omegaven 10%|
16360672|NCT00172185|Drug|teduglutide 0.05 mg/kg/d|0.05 mg/kg/d subcutaneous injection
16360673|NCT00172185|Drug|teduglutide 0.10 mg/kg/d|0.10 mg/kg/d subcutaneous injection
16360674|NCT00172172|Drug|PTH/Calcium|PTH(1-84) subcutaneous injection and calcium 700 mg oral
16360675|NCT00172172|Drug|PTH/placebo|PTH (1-84) injected subcutaneously and placebo provided orally
16360676|NCT00172172|Drug|placebo|Placebo injected subcutaneously and 700 mg calcium orally
16360677|NCT00172159|Procedure|Hepatic resection|
16360678|NCT00172133|Drug|ALX1-11 (drug)|100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
16360679|NCT00172120|Drug|ALX1-11|
16360680|NCT00172107|Drug|ALX1-11 50 mcg|PTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen
16360681|NCT00172107|Drug|placebo|placebo powder for subcutaneous injection
16360682|NCT00172107|Drug|ALX1-11 75mcg|PTH(1-84)75 mcg for subcutaneous injection
16360683|NCT00172107|Drug|ALX1-11|PTH (1-84) 100mcg for subcutaneous injection into thigh or abdomen
16360684|NCT00172094|Drug|NPS 1776 (800 mg)|NPS 1776 (800 mg) powder
16360685|NCT00172094|Drug|PLACEBO|Placebo in non-carbonated fruit flavored drink (150 ml)
16360686|NCT00172094|Drug|NPS 1776 (400 mg)|NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
16360687|NCT00172081|Drug|placebo|Daily subcutaneous injection with placebo
16360688|NCT00172081|Drug|ALX1-11|PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen
16360689|NCT00172068|Drug|Zoledronic acid + Calcium/Vitamin D|
16360690|NCT00172055|Drug|Zoledronic acid|
16360691|NCT00172042|Drug|Zoledronic acid 4 mg|Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
16360692|NCT00172029|Drug|Zoledronic acid|
16360693|NCT00172016|Drug|Zoledronic acid|
16360694|NCT00172003|Drug|Zoledronic acid|
16360695|NCT00171990|Drug|Famciclovir|
16360696|NCT00171977|Drug|Imatinib Mesylate|
16360697|NCT00171964|Drug|Zoledronic acid in combination with therapy|
16360698|NCT00171951|Drug|Pasireotide|Pasireotide 600 μg or 900 μg was administered as an SC injection.
16360699|NCT00171938|Drug|imatinib mesylate|
16360700|NCT00171925|Drug|Zoledronic acid|Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance > 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg*hr/l).
16360701|NCT00171925|Dietary Supplement|Calcium / Vitamin D|Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
16360702|NCT00171912|Drug|imatinib mesylate|
16360703|NCT00171899|Drug|imatinib mesylate|
16360704|NCT00171886|Drug|Octreotide|
16360705|NCT00171873|Drug|Octreotide LAR (Long-acting release)|30 mg intramuscularly every 28 days
16360706|NCT00171873|Drug|Placebo|Sodium chloride intramuscularly every 28 days
16360707|NCT00171860|Drug|imatinib mesylate|
16360709|NCT00171847|Drug|Trastuzumab plus Letrozole|
16360710|NCT00171847|Drug|Letrozole|
16360711|NCT00171834|Drug|Patupilone|Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.
16360712|NCT00171821|Drug|Deferasirox|
16360713|NCT00171808|Drug|Letrozole|
16360714|NCT00171795|Drug|Rivastigmine|
16360715|NCT00171782|Drug|VALSARTAN+HYDROCHLOROTHIAZIDE|
16360716|NCT00171769|Drug|Certoparin|
16360717|NCT00171756|Drug|valsartan/atenolol|
16360718|NCT00171743|Drug|Cyclosporine microemulsion|
16360719|NCT00171730|Drug|Pasireotide|
16360720|NCT00171717|Drug|Cyclosporine - cyclosporine microemulsion|
16360721|NCT00171704|Drug|Letrozole|2.5 mg tablets and supplied in bottles with 6-monthly supplies.
16360722|NCT00171704|Drug|Tamoxifen|20 mg tablets in bottles as 6-monthly supplies (supplied to Novartis as Tamofen from Schering Oy, Subsidiary of Schering AG, Pansiontie 47, FIN-2010 Turku, Finland)
16360723|NCT00171691|Drug|Diclofenac Topical Sodium Gel 1%|
16360724|NCT00171678|Drug|Diclofenac Topical Sodium Gel 1%|
16360725|NCT00171665|Drug|Diclofenac topical sodium gel 1%|
16360726|NCT00171652|Drug|Diclofenac sodium gel 1%|
16360727|NCT00171639|Drug|zoledronic acid|
16360728|NCT00171626|Drug|Diclofenac Topical Sodium Gel 1%|
16360729|NCT00171613|Drug|Octreotide|
16360730|NCT00171600|Drug|VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ|
16360731|NCT00171587|Drug|PTK787/ZK 222584 (vatalanib)|
16360732|NCT00171574|Drug|Valsartan|
16360733|NCT00171574|Drug|Valsartan plus HCTZ|
16360734|NCT00171574|Drug|Lisinopril|
16360735|NCT00171561|Drug|valsartan/hydrochlorothiazide|
16360736|NCT00171535|Drug|valsartan/amlodipine|
16360737|NCT00171522|Drug|Tegaserod and Polyethylene Glycol 3350|
16360738|NCT00171509|Drug|Cyclosporine microemulsion|
16360739|NCT00171496|Drug|Cyclosporine microemulsion|
16360740|NCT00171496|Drug|Tacrolimus|
16360741|NCT00171483|Drug|Tegaserod|
16360742|NCT00171470|Drug|Tegaserod|
16360743|NCT00171457|Drug|Tegaserod|
16360744|NCT00171444|Behavioral|Medical education|
16360745|NCT00171431|Drug|Tegaserod|
16360746|NCT00171418|Drug|Tegaserod|
16360747|NCT00171405|Drug|aliskiren|
16360748|NCT00171392|Drug|Enteric-coated mycophenolate sodium|
16360749|NCT00171379|Drug|Enteric-Coated Mycophenolate Sodium|
16360750|NCT00171366|Drug|amlodipine/benazepril|
16360751|NCT00171353|Drug|valsartan|
16360752|NCT00171340|Drug|Zoledronic acid|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
16360753|NCT00171340|Drug|Letrozole|Letrozole tablets 2.5 mg/day taken orally for 5 years.
16360754|NCT00171327|Drug|valsartan, fluvastatin|
16360755|NCT00171314|Drug|Zoledronic acid|Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
16360756|NCT00171314|Drug|Letrozole|Letrozole tablets 2.5 mg/day/taken orally for 5 years.
16360757|NCT00171301|Drug|Deferasirox|Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.
16360758|NCT00171288|Drug|fluvastatin, ezetimibe|
16360759|NCT00171275|Drug|Fluvastatin|
16360760|NCT00171262|Drug|Fluvastatin|
16360761|NCT00171249|Drug|STI571 400 mg|STI571 capsules and tablets
16360762|NCT00171249|Drug|STI571 600 mg|STI571 capsules and tablets
16360763|NCT00171236|Drug|Fluvastatin|
16360764|NCT00171223|Drug|STI571|STI571 oral capsules or tablets.
16360765|NCT00171210|Drug|Deferasirox|Tablets taken orally once a day.
16360766|NCT00171184|Drug|Darifenacin|Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
16360767|NCT00171184|Drug|Placebo|Placebo tablet once daily with sham titration
16360768|NCT00171171|Drug|deferasirox|
16360769|NCT00171158|Drug|imatinib mesylate|
16360770|NCT00171145|Drug|Darifenacin|Darifenacin 15 mg tablets once daily
16360771|NCT00171145|Drug|Placebo|Placebo tablets once daily
16360772|NCT00171132|Drug|valsartan|
16360773|NCT00171132|Drug|atenolol|
16360774|NCT00171132|Drug|hydrochlorothiazide|
16360775|NCT00171119|Drug|valsartan|
16360776|NCT00171106|Drug|valsartan|
16360777|NCT00171093|Drug|valsartan + simvastatin|
16360778|NCT00171080|Drug|valsartan|
16360779|NCT00171080|Drug|irbesartan|
16360780|NCT00171067|Drug|valsartan|
16360781|NCT00171067|Drug|lisinopril|
16360782|NCT00171054|Drug|Valsartan 320 mg|Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks.
16360783|NCT00171054|Drug|Amlodipine 10 mg|Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks.
16360784|NCT00171054|Drug|Hydrochlorothiazide|At Week 12, patients who did not meet target Blood Pressure for both Systolic Blood Pressure < 140 mmHg and Diastolic Blood Pressure < 90 mmHg were eligible to receive 12.5 mg open-label Hydrochlorothiazide for the following 26 weeks.
16360785|NCT00171041|Drug|valsartan|
16360786|NCT00171028|Drug|valsartan|
16360787|NCT00171015|Drug|valsartan plus hydrochlorothiazide|
16360788|NCT00171002|Drug|valsartan/amlodipine|
16360789|NCT00170989|Drug|valsartan plus hydrochlorothiazide|
16360790|NCT00170976|Drug|valsartan + amlodipine|
16360791|NCT00170963|Drug|valsartan/amlodipine|
16360792|NCT00170950|Drug|Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1|Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.
16360858|NCT00170300|Device|Implantable Cardiac Resynchronisation (pacing) device|
16360793|NCT00170950|Drug|Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2|Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.
16360794|NCT00170950|Drug|Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter|Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.
16360795|NCT00170950|Drug|Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.
16360796|NCT00170950|Drug|Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.
16360797|NCT00170950|Drug|Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.
16360798|NCT00170937|Drug|valsartan plus hydrochlorothiazide|
16360799|NCT00170924|Drug|Valsartan|
16360800|NCT00170911|Drug|AAE581|
16360801|NCT00170898|Drug|Lumiracoxib|
16360802|NCT00170885|Drug|Everolimus|
16360803|NCT00170872|Drug|Lumiracoxib|
16360804|NCT00170859|Drug|Everolimus|
16360805|NCT00170846|Drug|Everolimus (RAD001)|
16360806|NCT00170846|Drug|Calcineurin Inhibitors (CNI)|
16360807|NCT00170846|Drug|Mycophenolate acid (MPA)/Azathioprine (AZA)|
16360808|NCT00170846|Drug|Steroids|
16360809|NCT00170833|Drug|Everolimus|
16360810|NCT00170820|Drug|Everolimus|
16360811|NCT00170794|Drug|Everolimus (RAD001)|
16360812|NCT00170781|Drug|Lumiracoxib|
16360813|NCT00170768|Drug|Darifenacin|Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
16360814|NCT00170768|Drug|Oxybutynin|Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
16360815|NCT00170768|Drug|Placebo|Placebo once daily tablet (sham titration)
16360816|NCT00170755|Drug|Darifenacin|Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
16360817|NCT00170742|Drug|Octreotide, 30 mg i.m. LAR formulation|
16360818|NCT00170729|Drug|Prednisolone acetate|
16360819|NCT00170716|Device|Cortical Stimulation and rehabilitation|Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
16360820|NCT00170716|Other|Rehabilitation|Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
16360821|NCT00170703|Device|Cortical Electrical Stimulation|
16360822|NCT00170690|Drug|Treosulfan|Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
16360823|NCT00170690|Drug|Treosulfan|Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
16360824|NCT00170677|Drug|Topotecan|Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
16360825|NCT00170677|Drug|Topotecan|Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
16360826|NCT00170664|Drug|Paclitaxel|
16360827|NCT00170664|Drug|Carboplatin|
16360828|NCT00170625|Drug|Hycamtin|Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
16360829|NCT00170612|Biological|Pneumovax 23|23-valent PPS, 25 micrograms/serotype
16360830|NCT00170612|Biological|Prevnar|7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype
16360831|NCT00170586|Device|Underglove coating (skin barrier)|
16360832|NCT00170573|Drug|Caelyx|Caelyx 40 mg/ m2biweekly
16360833|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
16360834|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
16360835|NCT00170547|Biological|Trivalent inactivated influenza vaccine|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
16360836|NCT00170534|Behavioral|Behavior|
16360837|NCT00170508|Biological|Fluzone®|
16360838|NCT00170469|Biological|AVA|
16360839|NCT00170469|Biological|rPA vaccine containing alhydrogel|
16360840|NCT00170456|Biological|rPA vaccine containing alhydrogel|
16360841|NCT00170443|Biological|rHAO Trivalent Influenza Vaccine|
16360842|NCT00170430|Drug|Fluconazole|
16360843|NCT00170430|Drug|Metronizadole|
16360844|NCT00170417|Behavioral|Cognitive Behaviour Therapy|
16360845|NCT00170404|Drug|Folic Acid|
16360846|NCT00170404|Drug|Micronutrients: Vitamins B1, B2, B6, Niacin, B12, C, E.|
16360847|NCT00170404|Drug|Selenium|
16360848|NCT00170404|Drug|Vitamin A|
16360849|NCT00170391|Behavioral|Quarter of an Hour rule|
16360850|NCT00170378|Drug|Enoxaparin|
16360851|NCT00170365|Behavioral|Restorative Yoga|
16360852|NCT00170352|Procedure|Hyperbaric Oxygen Treatment (HBOT)|
16360853|NCT00170352|Procedure|Enhanced Oxygen Treatment (Enhanced FiO2)|
16360854|NCT00170326|Procedure|dual-chamber pacemaker implantation|Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.
16360855|NCT00170326|Procedure|biventricular dual-chamber pacemaker implant|Biventricular pacemaker system or in case in ICD indication a BIV ICD
16360856|NCT00170313|Device|Conducted AF-Response Algorithm (CAFR) On|Algorithm will be enabled.
16360857|NCT00170313|Device|Conducted AF-Response Algorithm (CAFR) Off|Algorithm will be disabled.
16360968|NCT00169247|Drug|cetuximab|
16360859|NCT00170287|Procedure|ICD Ablation plus VT-ablation|ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
16360860|NCT00170287|Device|ICD Therapy|ICD Therapy for the Treatment of unstable VT´s
16360861|NCT00170274|Device|Activation of preventive and therapeutic algorithms for treatment of AF|Algorithms in At 500 or Enrhyhtm for prevention and termination of Atrial Fibrillation
16360862|NCT00170274|Device|AF Prevention and Therapy Algorithms On|Activation of AF-prevention and termination algorithms in AT 500 or EnRhyhtm
16360863|NCT00170261|Device|Use of an Implantable Loop Recorder|
16360864|NCT00170248|Device|computer-based decision support for asthma management|The asthma management decision support system uses data from the patient problem and medication list to provide patient-specific management recommendations based on Canadian Consensus guidelines for asthma management. Web-enabled technology for asthma education nurses is used to collect home-monitoring information from patients between visits and feedback to primary care physicians in accordance with options selected by the physician for each patient.
16360865|NCT00170235|Other|Prehabilitation|Exercise class pre-surgery
16360866|NCT00170235|Other|Usual care|Exercise booklet, physiotherapy if needed
16360867|NCT00170222|Drug|doxycycline|
16360868|NCT00170209|Drug|Isoniazid|The dosage of the medication is determined according to the weight of the child. The dose is once per day, 10-15 mg/kg/day (max=300mg/day). Total duration of treatment is 9 months. Both a detailed dose chart calculating doses by weight and age and protocols for preparation of medications (crushing pills, mixing suspensions) are available.
16360869|NCT00170209|Drug|Rifampin|The dosage of the medication is determined according to the weight of the child. The dose is once per day, 10-20 mg/kg/day (max=600mg/day). Total duration of treatment is 4 months. Both a detailed dose chart calculating doses by weight and age and protocols for preparation of medications (crushing pills, mixing suspensions) are available.
16360870|NCT00170196|Drug|prednisone|
16360871|NCT00170183|Drug|Nesiritide|
16360872|NCT00170157|Drug|Bicalutamide|Given orally
16360873|NCT00170157|Drug|Flutamide|Given orally
16360874|NCT00170157|Drug|Goserelin Acetate|Given SC
16360875|NCT00170157|Drug|Ipilimumab|Given IV
16360876|NCT00170157|Drug|Leuprolide Acetate|Given IM
16360877|NCT00170157|Other|Pharmacological Study|Correlative study
16360878|NCT00170144|Drug|Branchamin 4%|
16360879|NCT00170118|Behavioral|motivational interviewing|
16360880|NCT00170079|Behavioral|Smoking Cessation Intervention|"A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:
~Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;
~Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and
~Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition."
16360881|NCT00170053|Drug|Sirolimus|10 mg oral loading dose followed by 5 mg/day. Measure Sirolimus level weekly and adjust to level of 10-15 ng/ml.
16360882|NCT00170027|Device|Magnetocardiograph|
16360883|NCT00170014|Device|Magnetocardiograph|
16360884|NCT00170001|Drug|Nexium|40 mg bid dosing
16360885|NCT00170001|Drug|Sugar Pill|40 mg BID
16360886|NCT00169988|Drug|risperidone|
16360887|NCT00169988|Drug|sertraline-primary|
16360888|NCT00169975|Device|Magnetocardiograph|MCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored.
16360889|NCT00169962|Drug|rhDNAse (pulmozyme)|
16360890|NCT00169949|Drug|aripiprazole|
16360891|NCT00169936|Device|Magnetocardiograph|
16360892|NCT00169923|Drug|rosiglitazone|
16360893|NCT00169910|Drug|AUC monitored withdrawal of MMF or CNI|AUC monitored withdrawal of MMF or CNI from a immunosuppressive drug regimen with steroids, CNI and MMF in stable renal transplant recipients
16360894|NCT00169897|Behavioral|Pulmonary rehabilitation (teaching and exercise)|After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.
16360895|NCT00169884|Behavioral|cognitive-behavioural therapy|
16360896|NCT00169858|Biological|Engerix-B|10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.
16360897|NCT00169845|Dietary Supplement|Alpha-Tocopherol and Beta-Carotene|Provided by Roche Vitamins Inc.
16360898|NCT00169845|Dietary Supplement|Placebo|Provided by Roche Vitamins Inc
16360899|NCT00169832|Drug|Rosiglitazone or placebo|Rosiglitazone 4 to 8 mg/day or placebo, for 12 months
16360900|NCT00169819|Drug|Abciximab|
16360901|NCT00169806|Other|videotape for mapping of renal anatomy and papillary biopsy|Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.
16360902|NCT00169793|Other|evaluation of kidney stone risk after bariatric surgery|24 hour urine collections done pre and post surgery
16360903|NCT00169793|Other|Evaluate risk of kidney stones after bariatric surgery|24 hour urine collections are done before and after surgery
16360969|NCT00169247|Drug|Cisplatin|
16360970|NCT00169247|Procedure|Radiotherapy 70 Gy, 35 fractions|
16360971|NCT00169234|Biological|PCV7, Prevnar®|Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
16360972|NCT00169234|Biological|Pneumovax 23|Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
16360904|NCT00169780|Radiation|High definition helical CT (64 head scanner)|"Patients who require a CT scan for diagnostic purposes prior to kidney stone surgery will undergo a high definition helical CT rather than the standard CT scan. This high resolution scan will then be reviewed by the researchers to help determine the type of treatment needed for the kidney stone removal. The aim is to see if the higher resolution will show more of the stone anatomy which will help the surgeon determine if the stone will be amenable to shock wave lithotripsy or if another type of treatment would best serve the patient needs."
16360905|NCT00169767|Other|Comparison study between KTP and HoLAP for BPH|Comparison study between KTP and HoLAp for BPH
16360906|NCT00169754|Other|mapping kidney anatomy|videotape of surgical procedure to document location of attached stones and condition of calyces and papilla.
16360907|NCT00169741|Other|Renogram|Subjects who enroll in this study will undergo a nuclear scan called a renogram to assess renal function prior to surgery (baseline), approximately one hour after surgery (to assess percutaneous effects on renal function) and finally approximately 6 weeks post-operatively (to assess return to baseline).
16360908|NCT00169728|Biological|DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa|
16360909|NCT00169728|Biological|heptavalent pneumococcal conjugate vaccine, Prevenar|
16360910|NCT00169715|Procedure|Percutaneous Caliceal Diverticuli|Standard of care to remove a stone from a caliceal diverticulum is to do a percutaneous procedure for stone removal and then fulgerate the diverticulum to prevent stone recurrence. We plan to aspirate urine from this diverticulum and compare it to urine collected from the renal pelvis of the same kidney.
16360911|NCT00169702|Behavioral|weight management program|12 sessions, psychoeducation
16360912|NCT00169702|Behavioral|weight management program|2 weekly, 12 sessions, psychoeducational weight management
16360913|NCT00169689|Procedure|"rTMS, repetitive transcranial magnetic stimulation"|10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex
16360914|NCT00169689|Other|rTMS|repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks
16360915|NCT00169676|Other|observation|registry and database for surgery outcomes
16360916|NCT00169650|Other|Registry and database|Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction at Methodist Urology in Indiana will be asked to participate in a registry and database to review outcomes of the surgery.
16360917|NCT00169637|Drug|rhGH|
16360918|NCT00169624|Drug|Metformin|
16360919|NCT00169624|Drug|Gliclazide|
16360920|NCT00169611|Drug|methylphenidate|
16360921|NCT00169598|Procedure|positron emission tomography|
16360922|NCT00169585|Drug|Levofloxacin oral tablets|
16360923|NCT00169572|Drug|Aprepitant|
16360924|NCT00169572|Drug|Ondansetron|
16360925|NCT00169572|Drug|GW679769|
16360926|NCT00169572|Drug|Dexamethasone|
16360927|NCT00169559|Drug|GW590735|1µg to 20µg daily doses of GW590735
16360928|NCT00169559|Drug|fenofibrate|Marketed Drug
16360929|NCT00169546|Drug|Salmeterol/fluticasone propionate|
16360930|NCT00169546|Drug|Fluticasone propionate|
16360931|NCT00169533|Drug|GW572016 oral tablets|Lapatinib either at 750, 1000, 1250 or 1500 mgs
16360932|NCT00169520|Drug|docetaxel|
16360933|NCT00169520|Drug|SB-715992|
16360934|NCT00169507|Biological|Pneumococcal (vaccine)|
16360935|NCT00169494|Biological|HPV-16/18 L1/AS04|
16360936|NCT00169481|Biological|Pneumococcal (vaccine)|
16360937|NCT00169468|Drug|Rituximab -CHOP plus Velcade|
16360938|NCT00169455|Biological|Live attenuated human rotavirus vaccine|
16360939|NCT00169442|Biological|Tritanrix™-HepB/Hiberix™ Kft.|GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
16360940|NCT00169442|Biological|Tritanrix™-HepB/Hiberix™|GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
16360941|NCT00169442|Biological|Hiberix™|GSK Biologicals' Haemophilus influenzae type b vaccine
16360942|NCT00169442|Biological|Polyribosil-Ribitol-Phosphate (PRP) vaccine|plain PRP polysaccharide vaccine
16360943|NCT00169442|Biological|Tritanrix™-HepB Kft|GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
16360944|NCT00169416|Drug|valaciclovir HCl granules|
16360945|NCT00169403|Procedure|Deep brain stimulation|
16360946|NCT00169377|Procedure|deep brain stimulation|Stimulator on followed by off
16360947|NCT00169377|Procedure|No stimulation|Stimulator off followed by on
16360948|NCT00169364|Device|positron emission tomography|
16360949|NCT00169338|Procedure|Deep brain stimulation|internal pallidal deep brain stimulation
16360950|NCT00169325|Procedure|Magnetic resonance imaging|
16360951|NCT00169312|Behavioral|behavioral dietary intervention|
16360952|NCT00169312|Dietary Supplement|dietary intervention|
16360953|NCT00169312|Other|educational intervention|
16360954|NCT00169312|Other|internet-based intervention|
16360955|NCT00169312|Other|preventative dietary intervention|
16360956|NCT00169312|Procedure|evaluation of cancer risk factors|
16360957|NCT00169299|Drug|Black cohosh|
16360958|NCT00169299|Drug|Multibotanical preparation|
16360959|NCT00169299|Drug|Multibotanical preparation + dietary soy counseling|
16360960|NCT00169299|Drug|Conjugated equine estrogen +/- medroxyprogesterone acetate|
16360961|NCT00169286|Procedure|Telephone care management|
16360962|NCT00169286|Procedure|peer-led chronic disease self-management workshop|
16360963|NCT00169286|Procedure|professionally-led cognitive behavioral psychotherapy group|
16360964|NCT00169273|Behavioral|Structured behavioral weight loss group|Structured group weight loss program
16360965|NCT00169273|Behavioral|Weight loss and cognitive-behavioral depression group|Structured group program for weight loss and depression
16360966|NCT00169260|Behavioral|motivational counseling|behavioral motivational counselling
16360967|NCT00169260|Behavioral|placebo|
16360973|NCT00169221|Drug|Iressa (Gefitinib)|postoperative chemoradiotherapy with cisplatin + gefitinib
16360974|NCT00169221|Radiation|chemoradiotherapy with cisplatin|postoperative chemoradiotherapy with cisplatin
16360975|NCT00169208|Drug|rituximab|375 mg/m² IV, D1 each cycle during 4 cycles
16360976|NCT00169208|Drug|fludarabine|40 mg/m²/day IV , D1 each cycle during 4 cycles
16360977|NCT00169208|Drug|mitoxantrone|10 mg/m² IV, D2-3-4 each cycle during 4 cycles
16360978|NCT00169195|Drug|Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)|
16360979|NCT00169182|Drug|DOCETAXEL|75 mg/m 2 on day 1
16360980|NCT00169182|Drug|Cisplatin|75 mg/m 2 on day 1
16360981|NCT00169182|Drug|5-Fluoro-3-Pyridinecarboxylic Acid|750 mg/m 2 by 24-hour continuous infusion for 5 days
16360982|NCT00169169|Drug|ACVBP|
16360983|NCT00169169|Drug|ACE|
16360984|NCT00169169|Drug|rituximab|
16360985|NCT00169169|Procedure|Autologous stem cell transplant|
16360986|NCT00169156|Drug|Rituximab|375 mg/m2 D1
16360987|NCT00169156|Drug|Prednisone|40 mg/m2 D1 to D5
16360988|NCT00169156|Drug|Doxorubicine|50 mg/m2 D1
16360989|NCT00169156|Drug|Cyclophosphamide|750 mg/m2 D1
16360990|NCT00169156|Drug|Vincristine|1,4 mg/m2 D1
16360991|NCT00169143|Drug|Rituximab + ACVBP regimen plus Pegfilgrastim|
16360992|NCT00169143|Procedure|Autologous stem cell transplant|
16360993|NCT00169130|Drug|doxorubicin|
16360994|NCT00169130|Drug|cyclophosphamide|
16360995|NCT00169130|Procedure|Autologous stem cell transplantation|
16360996|NCT00169117|Behavioral|Songs/posters aimed at behaviour change|This was a behavioural intervention, using songs and posters composed/designed by community members which aimed at behaviour change to increase repair and maintenance of mosquito nets
16360997|NCT00169104|Drug|G-CSF|5 mcgm/kg daily Monday through Friday weeks 3-14
16360998|NCT00169104|Drug|trastuzumab|4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14
16360999|NCT00169104|Drug|vinorelbine|25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13
16361000|NCT00169104|Drug|G-CSF|5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study
16361001|NCT00169104|Drug|saline placebo|Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study
16361002|NCT00169091|Drug|Clozapine|Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 12.5 mg on Day 1 to up to 300 mg on Day 12.
16361003|NCT00169091|Drug|Haloperidol|Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 2 mg on Day 1 to up to 12 mg on Day 12.
16361004|NCT00169078|Drug|Chloroquine|
16361005|NCT00169065|Drug|Clozapine|
16361006|NCT00169065|Drug|Olanzapine|
16361007|NCT00169052|Behavioral|Health Care Management and Supported Rehabilitation|
16361008|NCT00169039|Drug|Clozapine|
16361009|NCT00169039|Drug|Chlorpromazine|
16361010|NCT00169026|Drug|Clozapine versus typical (conventional) and atypical antipsychotic medications|
16361011|NCT00169013|Drug|Gabapentin|
16361012|NCT00169000|Drug|Capecitabine|"Capecitabine at the following dose levels for 14 days every 21 days, beginning with dose level 1
~Dose level -2 600 mg/m2 po BID
~Dose level -1 700 mg/m2 po BID
~Dose level 1 825 mg/m2 po BID
~Dose level 2 1000 mg/m2 po BID"
16361013|NCT00169000|Drug|Docetaxel|75 mg/m2 over one hour on day 8 of each cycle
16361014|NCT00168987|Drug|oral nutritional supplement rich in eicosapentanoic acid|
16361015|NCT00168961|Dietary Supplement|High Protein Energy, Fresenius-Kabi (nutritional intervention)|
16361016|NCT00168948|Drug|Sulfadoxin (12.5) Pyrimethamine (250 mg)|
16361017|NCT00168935|Drug|Fresubin protein energy Drink (CAVE! nutritional intervention)|
16361018|NCT00168922|Drug|Bendamustin/Ribomustin|
16361019|NCT00168909|Drug|alfacalcidol|alfacalcidol 1 µg once daily, oral, for 3 years
16361020|NCT00168909|Drug|placebo|placebo once daily, oral, for 3 years
16361021|NCT00168896|Drug|Carboplatin plus Irinotecan vs Carboplatin plus Etoposide|
16361022|NCT00168883|Drug|Carboplatin|
16361023|NCT00168883|Drug|Paclitaxel|
16361024|NCT00168883|Drug|Vinorelbine|
16361025|NCT00168870|Drug|Gemcitabine|
16361026|NCT00168870|Drug|Treosulfan|
16361027|NCT00168857|Drug|telmisartan|
16361028|NCT00168857|Drug|losartan|
16361029|NCT00168844|Drug|Tiotropium Inhalation Solution|
16361030|NCT00168844|Other|Placebo|
16361031|NCT00168831|Drug|Tiotropium Inhalation Solution|
16361032|NCT00168831|Other|Placebo|
16361033|NCT00168818|Drug|dabigatran etexilate|daily dose 150 mg once daily, half a dose on the day of surgery
16361034|NCT00168818|Drug|dabigatran etexilate|daily dose 150 mg once daily, half a dose on the day of surgery
16361035|NCT00168818|Drug|enoxaparin|40 mg once daily
16361036|NCT00168805|Drug|enoxaparin|40 mg once daily
16361037|NCT00168805|Drug|dabigatran etexilate|150 mg once daily
16361038|NCT00168805|Drug|dabigatran etexilate|220 mg once daily
16361039|NCT00168792|Drug|Tenecteplase|
16361040|NCT00168792|Procedure|PCI|
16361041|NCT00168779|Drug|telmisartan 80 mg / hydrochlorothiazide 25 mg|
16361042|NCT00168779|Drug|valsartan 160 mg / hydrochlorothiazide 25 mg|
16361043|NCT00168779|Drug|placebo|
16361044|NCT00168766|Drug|Interferon-beta-1a (Avonex) plus methylprednisolone|oral administration given on 3 consecutive days, monthly as described in protocol.
16361045|NCT00168753|Drug|Alefacept|IM
16361046|NCT00168740|Drug|rituximab|
16361047|NCT00168727|Drug|ibritumomab tiuxetan (Zevalin®)|
16361048|NCT00168714|Drug|BG9418 (interferon beta-1a)|Exposure to Avonex during pregnancy
16361049|NCT00168701|Drug|BG00012|
16361050|NCT00168688|Dietary Supplement|multi micronutrient supplement|
16361110|NCT00168025|Drug|Immunoglobulins Intravenous (Human)|
16361111|NCT00168012|Drug|Immunoglobulins Intravenous (Human)|
16361112|NCT00167999|Drug|piperacillin-tazobactam|
16361051|NCT00168688|Dietary Supplement|MN1|Vitamin A 800 μg RE, Vitamin D 200 IU, Vitamin E 10 mg, Vitamin B1 1.4 mg, Vitamin B2 1.4 mg, Niacin 18 mg, Folic acid 400 μg, Vitamin B6 1.9 mg, Vitamin B12 2.6 μg, Vitamin C 70 mg, Zinc 15 mg, Iron 30 mg, Copper 2.0 mg, Selenium 65 μg, Iodine 150 μg
16361052|NCT00168688|Dietary Supplement|MN2|Vitamin A 1600 μg RE, Vitamin D 400 IU, Vitamin E 20 mg, Vitamin B1 2.8 mg, Vitamin B2 2.8 mg, Niacin 36 mg, Folic acid 800 μg, Vitamin B6 3.8 mg, Vitamin B12 5.2 μg, Vitamin C 140 mg, Zinc 30 mg, Iron 30 mg, Copper 4.0 mg, Selenium 130 μg, Iodine 300 μg
16361053|NCT00168662|Biological|Measles and inactivated polio vaccine|
16361054|NCT00168649|Drug|Vitamin A|
16361055|NCT00168636|Drug|Vitamin A|
16361056|NCT00168623|Drug|Vitamin A|
16361057|NCT00168610|Drug|Vitamin A|
16361058|NCT00168597|Drug|Vitamin A|
16361059|NCT00168584|Drug|Vitamin A|
16361060|NCT00168571|Biological|Measles vaccine|
16361061|NCT00168558|Biological|Measles vaccine|"The children will be randomised to the following three arms:
~Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age.
~Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age.
~Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age.
~V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine"
16361062|NCT00168545|Biological|Measles vaccine|
16361063|NCT00168532|Drug|Sulfamethoxazole-Trimethoprim|
16361064|NCT00168519|Drug|nitroprusside, pentalong, imdur, AICAR, isoptin|"Sodium Nitroprusside - one 30 minute intravenous infusion
~Pentalong - two tablets orally (total 160mg)
~Imdur - two tablets orally (total 120mg)"
16361065|NCT00168506|Drug|SSRI|
16361066|NCT00168506|Drug|CBT|
16361067|NCT00168506|Drug|CBT/SSRI|
16361068|NCT00168493|Drug|antidepressants primarily selective serotonin reuptake inhibitors|normal clinical dosages used according to clinical response as determined by a psychiatrist
16361069|NCT00168480|Biological|Botulinum Toxin Type A|100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period
16361070|NCT00168467|Drug|Ramipril|
16361071|NCT00168454|Biological|botulinum toxin Type A|botulinum toxin Type A injected into detrusor on Day 1
16361072|NCT00168454|Drug|Placebo|Placebo (normal saline) injected into detrusor on Day 1
16361073|NCT00168441|Drug|Botulinum Toxin Type A|
16361074|NCT00168428|Biological|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
16361075|NCT00168428|Other|placebo (saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
16361076|NCT00168415|Biological|Botulinum Toxin Type A|100 U up to 6 times during the study depending on the response to treatment
16361077|NCT00168402|Drug|Botulinum Toxin Type A|
16361078|NCT00168389|Drug|Dexamethasone|350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
16361079|NCT00168389|Other|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
16361080|NCT00168376|Device|Transcranial Magnetic Stimulation|
16361081|NCT00168363|Drug|brimonidine|
16361082|NCT00168350|Drug|memantine|
16361083|NCT00168337|Drug|Dexamethasone|350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
16361084|NCT00168337|Other|Sham|Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
16361085|NCT00168324|Drug|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
16361086|NCT00168324|Drug|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
16361087|NCT00168324|Other|Sham Injection|Sham injection on Day 0.
16361088|NCT00168311|Device|Transcranial Magnetic Stimulation|Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.
16361089|NCT00168311|Device|sham TMS|
16361090|NCT00168298|Drug|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
16361091|NCT00168298|Drug|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
16361092|NCT00168298|Other|Sham Injection|Sham injection on Day 0.
16361093|NCT00168285|Behavioral|Pulmonary Rehabilitation|
16361094|NCT00168272|Device|Transcranial Magnetic Stimulation|
16361095|NCT00168181|Procedure|Submandibular gland Transfer|
16361096|NCT00168181|Drug|Salagen|
16361097|NCT00168168|Drug|G-CSF/Filgrastim|
16361098|NCT00168155|Drug|perioperative chemotherapy|
16361099|NCT00168129|Procedure|Helical tomotherapy|
16361100|NCT00168116|Procedure|radiation treatment and surgery|
16361101|NCT00168116|Procedure|radiation alone|
16361102|NCT00168103|Biological|C1 Esterase Inhibitor|Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.
16361103|NCT00168103|Biological|Placebo|Single application of physiological saline solution equivalent to the volume calculated for subjects in the C1-INH 20 U/kg bw arm.
16361104|NCT00168090|Drug|Blood coagulation Factor VIII and vWF, human|
16361105|NCT00168077|Drug|Prothrombin Complex Concentrate|
16361106|NCT00168064|Drug|mechlorethamine-MCH (nitrogen mustard)|All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
16361107|NCT00168051|Drug|ReFacto|
16361108|NCT00168051|Drug|Advante|
16361109|NCT00168038|Biological|Immunoglobulin Intravenous (Human)|A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
16361113|NCT00167986|Drug|vancomycin-resistant enterococci and ESBL|
16361114|NCT00167960|Drug|Piperacillin/tazobactam and other β-lactam/β-lactamase|
16361115|NCT00167947|Drug|Cyclosporine|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
16361116|NCT00167947|Drug|Steroids|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
16361117|NCT00167947|Drug|Rapamune (Sirolimus)|"Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
16361118|NCT00167934|Drug|Valproate|Depakote ER 500 mg to 3000 mg taken every night
16361119|NCT00167934|Drug|Placebo|Placebo given at same frequency as Valproate
16361120|NCT00167921|Drug|Premarin® Vaginal Cream|
16361121|NCT00167921|Drug|Premarin® oral tablets|
16361122|NCT00167908|Drug|Ethyol (drug)|
16361123|NCT00167895|Procedure|Adding platelet concentrate to the wound|
16361124|NCT00167882|Drug|5-aminosalicylate (Pentasa, Ferring)|
16361125|NCT00167869|Behavioral|dairy peptides|
16361126|NCT00167856|Drug|Venalafaxine hydrochloride|Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
16361127|NCT00167843|Drug|sulfadoxine-pyrimethamine|
16361128|NCT00167830|Behavioral|Motivational Interviewing|Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.
16361129|NCT00167830|Behavioral|Strength and Cardiovascular Conditioning|Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.
16361130|NCT00167830|Behavioral|Food selection and portion control|Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.
16361131|NCT00167817|Drug|Aripiprazole|
16361132|NCT00167804|Behavioral|Virtual Reality Exposure|VRE uses computer generated environments to conduct exposure therapy.
16361133|NCT00167791|Drug|rituximab|Rituximab 375mg/m2 IV weekly times 4 weeks
16361134|NCT00167778|Device|Transverse plane rotation adaptor pylon|Potential future practice
16361135|NCT00167778|Device|Rigid pylon|Current clinical practice
16361136|NCT00167765|Drug|Abciximab|
16361137|NCT00167739|Drug|Quinine plus sulfadoxine-pyrimethamine|
16361138|NCT00167713|Drug|Ibuprofen|
16361139|NCT00167700|Behavioral|Dietary counselling and placebo|Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Placebo capsules.
16361140|NCT00167700|Behavioral|Dietary counselling and probiotics|Counseling to conform with the dietary recommendations. Food products commercially available including spreads and salad dressing. Probiotics
16361141|NCT00167700|Dietary Supplement|Placebo capsules|Placebo capsules
16361142|NCT00167700|Dietary Supplement|Probiotics|
16361143|NCT00167700|Dietary Supplement|Prebiotics|
16361144|NCT00167687|Drug|prazosin|"Pharmacological treatment: In order to prevent the possible side effect of first-dose hypotension, all participants will receive only 1mg of study medication or placebo nightly for the first two days of study participation. Titration will proceed according to the following schedule:
~Prazosin Dosing: 9 AM 3 PM 9 PM Days 1-2 1 mg (one capsule) Days 3-4 1 mg 1 mg 1 mg Days 5-7 2 mg 2 mg 2 mg Day 8-10 2 mg 2 mg 6 mg Day 11-14 4 mg 4 mg 6 mg Day 15-42 4 mg 4 mg 8 mg"
16361145|NCT00167674|Drug|Combined short-course zidovudine/nevirapine|300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight > 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.
16361146|NCT00167674|Drug|HAART|300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.
16361147|NCT00167661|Drug|Campath-1H|two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
16361148|NCT00167648|Drug|Leuprolide or goserelin|Leuprolide 7.5 mg (4-week depot) or goserelin 3.6 mg (4-week depot)
16361149|NCT00167648|Drug|Transdermal estradiol|Estradiol patches, six at 0.1 mg each, changed every 3-4 days
16361150|NCT00167635|Behavioral|cognitive-behavioral|Cognitive-behavioral over 9 weeks
16361151|NCT00167622|Procedure|mechanical ventilation|Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation
16361152|NCT00167622|Procedure|physiotherapy and oxygen if needed|oxygen will be delivered via facial mask whenever needed and physiotherapy
16361153|NCT00167609|Drug|dehydroepiandrosterone 100 and 400 mg|
16361154|NCT00167596|Device|Near Infrared Spectroscopy|resuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid
16361155|NCT00167596|Device|conventional|resuscitation will be based according to Surviving Sepsis Campaign
16361156|NCT00167583|Drug|Cyclosporin A|3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
16361157|NCT00167583|Drug|Interferon-alpha2a|3-6 million iU per day sc., augmented to up to 9 if necessary, later reduced (according to clinical response) to 3 x 3 million iU /week.
16361158|NCT00167570|Device|Prosthetic socket fabricated using selective laser sintering|
16361159|NCT00167557|Drug|Pegylated Interferon|180mcg SC weekly starting 30 days post transplant
16361160|NCT00167557|Drug|Ribavirin|goal dose 13mg/kg starting 120 days post transplant for a minimum of 48 wks
16361161|NCT00167557|Procedure|Liver Biopsy|Liver biopsies performed at 9 points in time from time of liver transplant
16361162|NCT00167544|Drug|Hydrocortisone|Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days
16361163|NCT00167544|Drug|Placebo|Saline
16361164|NCT00167531|Behavioral|treadmill walking with partial weight support|
16361165|NCT00167531|Behavioral|assisted overground walking|30 minutes per day of overground walking with the assistance of one therapist
16361166|NCT00167518|Drug|Triamcinolone acetate|
16361167|NCT00167505|Behavioral|Risk Avoidance Intervention|The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
16361168|NCT00167505|Behavioral|Risk Reduction Intervention|The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
16361169|NCT00167492|Drug|Myfortic|720 mg by mouth every 12 hours
16361170|NCT00167479|Drug|risperidone (Risperdal)|
16361171|NCT00167466|Device|Soladey-3 toothbrush|subject to brush with experimental Soladey-3 brush for 4 week
16361172|NCT00167466|Device|Placebo Soladey-3 toothbrush|subjects will brush with placebo Soladey-3 toothbrush for 4 weeks
16361173|NCT00167453|Procedure|Exercise, Education|
16361174|NCT00167414|Procedure|Hypofractionated Stereotactic Body Radiation Therapy|Hypofractionated Stereotactic Body Radiation Therapy
16361175|NCT00167414|Radiation|Hypofractionated Stereotactic Body Radiation Therapy|Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
16361176|NCT00167401|Drug|docetaxel|
16361177|NCT00167401|Drug|cisplatin|
16361178|NCT00167401|Procedure|radiation treatment|
16361179|NCT00167388|Other|feed during blood transfusion|babies receiving the intervention are fed during the PRBC transfusion
16361180|NCT00167375|Drug|eszopiclone 3 mg qHS|
16361181|NCT00167375|Behavioral|General cognitive/behavioral interventions for insomnia|
16361182|NCT00167362|Behavioral|Cognitive enhancement therapy (CET)|Using 80 to 100 hours of graduated exercises in computer assisted training, coupled with structured but unrehearsed in vivo social group interactions, CET tries to shift an early developmental reliance on effortful, serial and verbatim cognitive processing to a more gistful, less effortful and spontaneous abstraction of social themes. CET uses attention, memory and problem solving software from three exercises from Ben-Yishay's Orientation Remediation Module (the Attention Reaction Conditioner, Zero Accuracy Conditioner, and Time Estimates) that are graduated in difficulty and designed to enhance vigilance, selective attention, the ability to shift between auditory and visual modalities, and rapid decision-making.
16361183|NCT00167362|Behavioral|Enriched supportive therapy (EST)|EST is the commonly recommended (Spaulding 1992) treatment for control and experimental subjects in psychosocial trials. EST is a two-staged treatment that requires weekly one-hour sessions in Phase 1 and biweekly sessions in Phase 2. Some practice principles (e.g., psychoeducation and relaxation training) are provided during the group exercises for CET patients, but individually for EST patients. No attempt is made to control for hours of contact between EST and CET, since offering three hours of supportive therapy to EST subjects is neither logistically feasible nor faithful to the goals and methods of supportive therapy. Further, neurobiological hypotheses related to treatment specificity would be best tested by clear differences in treatment intensity and content.
16361184|NCT00167323|Behavioral|Adherence therapy|
16361185|NCT00167310|Drug|Eicosapentaenoic acid (omega-3 fatty acid)|2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
16361186|NCT00167310|Drug|Placebo|2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
16361187|NCT00167297|Drug|Atomoxetine|
16361188|NCT00167284|Behavioral|physician and patient education; physician practice redesign|
16361189|NCT00167271|Behavioral|Cognitive Behavior Therapy|Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
16361190|NCT00167258|Behavioral|Voucher Reinforcement|
16361191|NCT00167258|Behavioral|Extra Counseling Services|
16361192|NCT00167258|Behavioral|Voucher Reinforcement + Extra Counseling Services|
16361193|NCT00167245|Drug|Topiramate|300mg/day for 13 weeks
16361194|NCT00167245|Drug|placebo|placebo pills
16361195|NCT00167232|Drug|Naltrexone|
16361196|NCT00167219|Biological|Stem Cell Transplant|Transplantation on Day 0.
16361197|NCT00167219|Drug|Preparative Regimen|"Busulfan
~Cyclophosphamide
~Mesna
~Melphalan
~Anti-thymocyte Globulin (ATG)"
16361198|NCT00167206|Procedure|Hematopoietic Stem Cell Transplant|Bone marrow failure may be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
16361199|NCT00167206|Procedure|Thymic Shielding During Radiation|protecting the thymus during total body radiation (450 cGy administered)
16361200|NCT00167206|Procedure|Total Body Irradiation|Six days before the stem cells are given (day -6), subjects will receive total body irradiation with thymic shielding. Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus.
16361201|NCT00167206|Drug|Cyclophosphamide, Fludarabine|Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine, Cyclophosphamide via central line
16361202|NCT00167180|Procedure|Donor Lymphocyte Infusion|donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg
16361203|NCT00167180|Drug|Induction Chemotherapy|Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV
16361204|NCT00167167|Procedure|Donor Lymphocyte Infusion|"Certain immune cells in your donor's blood called lymphocytes have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's lymphocytes in the hope of activating the recipient's immune system to attack cancer."
16361205|NCT00167154|Drug|Risperidone and placebo comparator|Up to 2 mg risperidone or matching placebo daily
16361206|NCT00167141|Drug|injection of hormonal male contraceptive|testosterone injections 4 times
16361207|NCT00167128|Device|hearing aid, Phonak EduLink-FM System|
16361208|NCT00167115|Drug|Alcohol|
16361209|NCT00167102|Drug|Alefacept|Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.
16361210|NCT00167089|Behavioral|Treadmill Training|Partian body weight support treadmill training, 30 min/day * 3 days /week
16361211|NCT00167011|Procedure|CT|
16361212|NCT00166946|Procedure|foreskin from healthy adults for organotypic culture|
16361213|NCT00166907|Behavioral|Balance and Exercise|
16361214|NCT00166881|Drug|Docetaxel-Irinotecan|Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
16361215|NCT00166868|Drug|Lactobacillus casei rhamnosus (Lcr35)|
16361216|NCT00166868|Drug|Neomycin|
16361217|NCT00166855|Procedure|dynamic MRI and bone marrow sampling|
16361218|NCT00166842|Drug|sirolimus, cyclosporine, tacrolimus|
16361219|NCT00166829|Drug|sirolimus, tacrolimus, mycophenolate mofetil|
16361220|NCT00166816|Drug|sirolimus, cyclosporine, tacrolimus|
16361221|NCT00166803|Drug|Rosiglitazone|Rosiglitazone , 4 mg daily
16361222|NCT00166790|Drug|chemotherapy agents|
16361223|NCT00166790|Procedure|suction curettage|
16361224|NCT00166777|Procedure|exercise training|
16361225|NCT00166725|Drug|Octreotide LAR|
16361226|NCT00166712|Drug|Tacrolimus (TAC)|Tacrolimus (TAC) will be given standard of care by prescription twice a day (2.0 mg), orally. Doses will be adjusted by serum levels. The dose will be modified to achieve 12 hour trough concentrations of 5-8 ng/mL.
16361227|NCT00166712|Drug|Sirolimus|Sirolimus will be given standard of care by prescription, dosed at 5mg daily. The dosage will be adjusted by serum level to achieve 24 hour trough concentrations of 8-12 ng/mL by HPLC assay.
16361228|NCT00166712|Drug|Alemtuzumab|Patients receiving alemtuzumab will be premedicated with 50mg of diphenhydramine hydrochloride, and 650mg of acetaminophen 30-60 minutes to the first Alemtuzumab infusion. The of 30mg will be diluted in 100cc sterile 0.9% normal saline and infused over 2 hours. The infusion line must contain an in-line 0.22-micron filter. Alemtuzumab will be administered on the day of transplant (intraoperatively), and on post-operative day 2. Both doses will be administered while the patient is in the hospital. Alemtuzumab is supplied in single-use clear glass ampoules containing 30mg of alemtuzumab in 3mL of solution.
16361229|NCT00166712|Drug|Mycophenolate mofetil (MMF)|MMF will be given at 1.0-1.5gm, twice daily, orally. The first dose will be given pre-transplant, open label fashion.
16361230|NCT00166699|Procedure|ultrasound|The use of ultrasound to guide the insertion of combined spinal epidural needle
16361231|NCT00166686|Drug|Clonidine|
16361232|NCT00166673|Device|FreeStyle Navigator Continuous Glucose Monitoring System|
16361233|NCT00166660|Behavioral|NIDCAP (Newborn Individualized Developmental Care)|The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.
16361234|NCT00166647|Procedure|Blood Sampling|
16361235|NCT00166634|Procedure|Ambulatory Blood Pressure Monitoring (ABPM)|
16361236|NCT00166621|Drug|Buspirone|
16361237|NCT00166608|Procedure|Blood sampling|
16361238|NCT00166595|Drug|Risperidone|
16361239|NCT00166582|Device|electronic medication monitoring system|
16361240|NCT00166582|Behavioral|parent-adolescent communication and problem-solving skills|
16361241|NCT00166556|Drug|Campath-1H and Tacrolimus|
16361242|NCT00166543|Drug|TAS-108|
16361243|NCT00166530|Drug|ezetimibe (+) simvastatin|Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
16361244|NCT00166530|Drug|simvastatin|Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
16361245|NCT00166530|Drug|atorvastatin|20 mg atorvastatin once daily for 12 weeks. Tablets
16361246|NCT00166517|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
16361247|NCT00166517|Biological|Comparator: Placebo|3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
16361248|NCT00166504|Drug|ezetimibe (+) simvastatin|simvastatin/ezetimibe 10/20 mg
16361249|NCT00166504|Drug|atorvastatin|atorvastatin 10 mg
16361250|NCT00166491|Drug|Insulin|
16361251|NCT00166478|Drug|Exisulind Therapy|
16361252|NCT00166465|Drug|ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen)|
16361253|NCT00166452|Drug|Lenalidamide|
16361254|NCT00166439|Drug|Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)|"rituximab 375 mg/m2 IV Weekly x 4 1 cycle only
~dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles
~oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles
~cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles
~pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles"
16361255|NCT00166426|Drug|Exisulind|
16361256|NCT00166413|Drug|CC-5013|40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle
16361257|NCT00166400|Drug|metoprolol succinate|Treatment with potent beta-blockade titrated to the maximally tolerated dose.
16361258|NCT00166387|Procedure|Blood draw|A single blood draw.
16361259|NCT00166374|Procedure|balloon kyphoplasty|
16361260|NCT00166361|Device|Memokath 051 Ureteral Stent|The Memokath 051 ureter stent is used for the treatment of malignant or benign ureteric strictures in both men and women. The stent design consists of a tightly-coiled nickel-titanium alloy, with a diameter of 10.5 French (Fr) and a fluted proximal diameter expanding to 22 Fr. The stent is manufactured in multiple lengths which are chosen to position the device across the narrowed area rather than crossing the ureteropelvic or ureterovesical junction. It has a thermal memory system for its predetermined shape; the stent softens at temperatures below 10 degrees Celsius but regains its shape when heated above 55 degrees Celsius.
16361261|NCT00166361|Device|JJ Stent|A JJ stent is a flexible plastic tube that drains urine from the kidney to the bladder and is supposed to stay in place temporarily. There is a coil on each end to keep the stent in place, preventing the stent from migrating down and out from the kidney or up from the bladder into the ureter. The stent can stay in place for few weeks to 3 months or more depending on the indication. If left for more than 6-9 months some stents may get encrusted leading to stone formation around the stent.
16361262|NCT00166348|Behavioral|Cognitive Group Therapy|
16361263|NCT00166322|Procedure|IBZM-SPECT (bolus and constant infusion paradigm)|single IBZM-SPECT assessment at study inclusion
16361264|NCT00166309|Drug|FEIBA and NovoSeven|
16361265|NCT00166296|Drug|Escitalopram|15 mg/day starting 2 weeks before and 12 weeks during interferon therapy
16361266|NCT00166296|Drug|Placebo|Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
16361267|NCT00166283|Behavioral|memory retraining exercises|Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
16361268|NCT00166283|Behavioral|placebo control memory exercises|Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
16361269|NCT00166270|Device|ExAblate 2000|
16361270|NCT00166257|Device|Percutaneous closure of patent foramen ovale|Percutaneous implantation of an AMPLATZER® PFO Occluder
16361271|NCT00166257|Drug|Medical antitrhombotic treatment|Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
16361272|NCT00166244|Drug|Mycophenolate Mofetil|"1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients.
~Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma."
16361273|NCT00166218|Device|near-infrared spectroscopy|
16361274|NCT00166205|Device|Swedish Adjustable Gastric Band|Long term implantable device.
16361275|NCT00166192|Procedure|Jessner's solution chemical peel|
16361276|NCT00166192|Procedure|Trichloroacetic acid chemical peel|
16361277|NCT00166166|Drug|Tetraethylammonium (TEA)|5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min
16361278|NCT00166166|Drug|L-NG-monomethyl Arginine (L-NMMA)|5 minute intra-arterial infusion of L-NMMA 8 μmol/min
16361279|NCT00166166|Drug|Bradykinin|Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.
16361280|NCT00166166|Drug|Sodium nitroprusside|Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.
16361281|NCT00166166|Drug|Acetylcholine|Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.
16361282|NCT00166166|Drug|Saline|5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min
16361283|NCT00166166|Drug|Fluconazole|5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min
16361284|NCT00166153|Drug|Mycophenolate Mofetil|
16361285|NCT00166127|Drug|Levosimendan|
16361286|NCT00166114|Drug|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
16361287|NCT00166114|Drug|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
16361288|NCT00166088|Dietary Supplement|Mediterranean Diet|The Mediterranean diet group will receive all meals as a prototypical Mediterranean diet for 4 consecutive weeks prepared by the GCRC metabolic kitchen with dietary instruction. During the second month of the study they will be asked to follow a Mediterranean diet using their own home-cooked meals
16361289|NCT00166088|Dietary Supplement|Mediterranean Dietary Supplement|The subjects randomized to the typical diet + targeted Mediterranean dietary supplement group will not receive dietary counseling. They will be given a one-month supply of specific supplements by the GCRC nutritionists and advised to consume these daily, in addition to their usual diet.
16361290|NCT00166075|Procedure|Computer screen with community resource printout|Patients participated in the screening process via a computer kiosk. Questions regarding IPV and mental health symptoms were asked using validated tools
16361291|NCT00166062|Procedure|Screening patients for IPV|
16361292|NCT00166049|Behavioral|Family Partnership Intervention (FPI)|HF patient and family receive structured patient and family education sessions plus intervention to improve family communication one month after enrollment.Patient and family member received one individual dyadic education/counseling session after baseline data collection, and two group sessions (2-3 months after baseline) focused on developing family approaches to HF self management.Telephone counseling for the dyad and reinforcing mailed newsletters at 5-6 months after baseline.
16361293|NCT00166049|Behavioral|Patient and Family Education|HF Patient and one family member receive structured education sessions one month after enrollment.Two sessions, one indivdual with patient-family member dyad after baseline, and one in a group setting between 2-3 months after baseline. The group session was 2 hours in duration. Telephone counseling for the dyad ast 5-6 months, mailed newsletters at Mailed newsletters at 5-6 months.
16361294|NCT00166049|Behavioral|Usual care with educational material|Usual care with provision of printed educational material, provided once at baseline
16361295|NCT00166036|Drug|Atorvastatin|12 Weeks of Oral Atorvastatin 10 mg therapy.
16361296|NCT00166036|Drug|Pravastatin|12 Weeks of Oral Pravastatin 80 mg therapy.
16361297|NCT00166010|Drug|Nesiritide|Standard dose of nesiritide which is a loading dose of 1 mcg/kg IV over 30 minutes followed by a nesiritide infusion at 0.01mcg/kg/min. All patients will be continually evaluated. At any time the attending physician may add or adjust treatment if deemed clinically indicated.
16361298|NCT00165971|Procedure|BIS monitoring|
16361299|NCT00165958|Procedure|Excisional surgery of epidermal cyst|Traditional extirpation of cyst en toto
16361300|NCT00165958|Procedure|Punch incision of epidermal cyst|removal of cyst first with incisional effort with a punch biopsy tool
16361301|NCT00165919|Other|None. Not a clinical trial. Specimens taken for basic research in laboratory.|
16361302|NCT00165893|Device|Accu-Spina Device/IDD therapy|
16368621|NCT00107315|Drug|capecitabine|
16361303|NCT00165893|Procedure|Physical Therapy|
16361304|NCT00165880|Drug|E7070|
16361305|NCT00165867|Drug|E7070|
16361306|NCT00165854|Drug|E7070|
16361307|NCT00165841|Drug|Rabeprazole 20 mg|rabeprazole sodium tablet 20 mg once daily
16361308|NCT00165828|Drug|Zonegran|Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.
16361309|NCT00165815|Drug|ARICEPT|
16361310|NCT00165802|Drug|E7974|Maximum Tolerated Dose defined as 0.45 mg/m^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
16361311|NCT00165789|Drug|E2007|
16361312|NCT00165776|Drug|BOTULINUM TOXIN TYPE B|
16361313|NCT00165763|Drug|donepezil hydrochloride (Aricept)|5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.
16361314|NCT00165750|Drug|DONEPEZIL HYDROCHLORIDE|One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
16361315|NCT00165737|Drug|Donepezil Hydrochloride|
16361316|NCT00165724|Drug|Donepezil Hydrochloride|
16361317|NCT00165711|Drug|Mecobalamin|
16361318|NCT00165698|Drug|menatetranone|15 mg three times a day orally for 12 months
16361319|NCT00165698|Drug|alfacalcidol|0.25 μg twice a day orally for 12 months
16361320|NCT00165685|Drug|Sibutramine Hydrochloride Monohydrate|
16361321|NCT00165672|Drug|RABEPRAZOLE SODIUM|rabeprazole sodium 5 mg: once daily orally for 4 weeks
16361322|NCT00165672|Drug|RABEPRAZOLE SODIUM|rabeprazole sodium 10 mg: once daily orally for 4 weeks
16361323|NCT00165659|Drug|DONEPEZIL HYDROCHLORIDE|
16361324|NCT00165646|Drug|E3810|E3810 5mg: once daily orally for 4 weeks
16361325|NCT00165646|Drug|E3810|E3810 10mg: once daily orally for 4 weeks
16361326|NCT00165646|Drug|Placebo|Placebo: once daily orally for 4 weeks
16361327|NCT00165633|Drug|Menatetrenone|45 mg capsule, orally, three times a day, after meals.
16361328|NCT00165633|Drug|Menatetrenone|90 mg capsule, orally, three times a day, after meals.
16361329|NCT00165633|Drug|Placebo|Placebo capsule, orally, three times a day, after meals.
16361330|NCT00165620|Drug|Iomeprole|
16361331|NCT00165607|Drug|MENATETRANONE|
16361332|NCT00165594|Drug|E7070|
16361333|NCT00165581|Device|High Dose Intracavitary Brachytherapy|
16361334|NCT00165568|Drug|Bevacizumab|
16361335|NCT00165555|Drug|Cisplatin|Given as a heated one-hour lavage to the hemithorax after surgery.
16361336|NCT00165555|Drug|Sodium Thiosulfate|Given intravenously over 6 hours after the cisplatin lavage.
16361337|NCT00165542|Other|A PROTEIN level|
16361338|NCT00165516|Drug|Cisplatin|Heated and given as an one-hour lavage of the chest and abdomen during surgery
16361339|NCT00165516|Drug|Sodium Thiosulfate|After the one-hour lavage, sodium thiosulfate is given intravenously
16361340|NCT00165503|Drug|Cisplatin|
16361341|NCT00165503|Drug|Sodium Thiosulfate|
16361342|NCT00165503|Drug|ALIMTA|
16361343|NCT00165490|Drug|Cetuximab|Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
16361344|NCT00165490|Drug|Cisplatin|Given once per week on weeks 1, 2, 4,and 5.
16361345|NCT00165490|Drug|Irinotecan|Given once per week on weeks 1, 2, 4,and 5.
16361346|NCT00165490|Device|Radiation therapy|Once daily for 28 treatments (5 1/2 weeks)
16361347|NCT00165490|Procedure|Surgery|Surgery performed 4-8 weeks after chemoradiation therapy.
16361348|NCT00165477|Drug|lenalidomide|Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects
16361349|NCT00165477|Radiation|Radiation|Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks
16361350|NCT00165464|Drug|Taxotere|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
16361351|NCT00165464|Drug|Cisplatin|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
16361352|NCT00165464|Drug|Irinotecan|Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.
16361353|NCT00165451|Drug|Thalidomide|Oral administration once daily at night starting at 3mg/Kg for 6 months.
16361354|NCT00165451|Drug|Celecoxib|Oral administration twice daily starting at 100mg/dose for 6 months.
16361355|NCT00165451|Drug|Etoposide|Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months.
16361356|NCT00165451|Drug|Cyclophosphamide|Oral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months.
16361357|NCT00165438|Procedure|Pulmonary Function Tests|Tests include; total lung capacity, vital capacity, functional residual capacity, forced vital capacity, forced expiratory volume in 1 second, carbon monoxide diffusing capacity, pulse oximetry before and after a 6 minute walk and Pulmonary Status and Dyspnea Questionnaire
16361358|NCT00165438|Procedure|CAT Scan|Obtained at different time points during the study depending upon standard of care chemotherapy treatment
16361359|NCT00165425|Procedure|Echo/Stress Echo|Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist
16361360|NCT00165412|Procedure|breast MRI|Repeated once a year for three years
16361361|NCT00165412|Procedure|Mammogram|Repeated once a year for three years
16361362|NCT00165399|Drug|Docetaxel|Given intravenously on day 2 of four three-week cycles
16361363|NCT00165399|Drug|Estramustine|Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
16361364|NCT00165399|Drug|Casodex|Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
16361365|NCT00165399|Drug|Zoladex|Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.
16361366|NCT00165386|Procedure|Magnetic Resonance Imaging|
16361367|NCT00165386|Procedure|Bone Marrow Biopsy|
16361368|NCT00165373|Drug|rhEndostatin|Given by continuous infustion for 28 days (one of two dosing groups) for a total of 2 cycles. Treatment can be extended if tolerated well.
16361369|NCT00165360|Drug|Temozolomide|Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half
16361370|NCT00165347|Drug|PTK787/ZK222584|
16361371|NCT00165334|Drug|Cetuximab|
16361372|NCT00165334|Drug|Vinorelbine (Navelbine)|
16361373|NCT00165308|Drug|Tamoxifen|Given orally, daily for one year.
16361374|NCT00165295|Drug|Sildenafil citrate (Viagra)|
16361375|NCT00165282|Behavioral|Mindfulness training|Taught mindfulness meditation by mindfulness instructor (trained health care professional/RN) and audio c/d
16361376|NCT00165282|Behavioral|Nurse education|Meets with oncology nurse to have questions answered about medical treatments and side effects
16361377|NCT00165269|Procedure|Mantle irradiation|Limited to above the diaphragm
16361378|NCT00165256|Other|Observation|Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue
16361379|NCT00165243|Procedure|Tangential radiation|Radiation given over 6 1/2 weeks
16361380|NCT00165230|Drug|Thalidomide|
16361381|NCT00165230|Drug|Temodar|
16361382|NCT00165217|Drug|Capecitabine|
16361383|NCT00165217|Drug|Thalidomide|
16361384|NCT00165204|Drug|Tibolone|
16361385|NCT00165191|Drug|Doxorubicin|
16361386|NCT00165191|Drug|Cisplatin|
16361387|NCT00165191|Drug|5-fluorouracil|
16361388|NCT00165178|Drug|prednisone|Induction Phase: Given orally or intravenously Days 0-28 Intensification Phase: Given orally Days 1-5 of each cycle Continuation Phase: Given orally Days 1-5 of each cycle
16361389|NCT00165178|Drug|dexamethasone|Intensification Phase: Given orally days 1-5 of each cycle Continuation Phase: Given orally days 1-5 pf each cycle
16361390|NCT00165178|Drug|doxorubicin|Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle
16361391|NCT00165178|Drug|E. coli asparaginase|Intensification Phase: In the muscle weekly. Dose will vary
16361392|NCT00165178|Drug|vincristine|Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle
16361393|NCT00165178|Drug|methotrexate|Induction: Intravenously on Day 2 MLL Intensification: Intravenously on Days 1, 8 Intensification: (when doxorubicin completed) Intravenously or into the muscle weekly Continuation: Intravenously or into the muscle weekly
16361394|NCT00165178|Drug|Leucovorin|Induction Phase: Intravenously or orally begins 36 hours after methotrexate MLL Intensification: Intravenously or orally begins 36 hours after methotrexate
16361395|NCT00165178|Drug|Asparaginase|Induction: Into the muscle on Day 4 MLL Intensification: Into the muscle on Days 16, 23
16361396|NCT00165178|Drug|cytarabine|Induction: Intrathecal on Days 0, 14, 28 MLL Intensification: Intravenously on Days 15, 16, 22, 23
16361397|NCT00165178|Drug|Methotrexate/Hydrocortisone|Induction: Intrathecal on Days 14, 28 MLL Intensification: Intrathecal on Days 2,9
16361398|NCT00165152|Procedure|Genetic Counseling|Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
16361399|NCT00165152|Procedure|Informed Consent Counseling|Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
16361400|NCT00165139|Drug|Vincristine|Described under detailed description
16361401|NCT00165139|Drug|Cyclophosphamide|Described under detailed description
16361402|NCT00165139|Drug|Adriamycin|Described under detailed description
16361403|NCT00165139|Drug|Etoposide (VP-16)|Described under detailed description
16361404|NCT00165139|Drug|Cisplatin|Described under detailed description
16361405|NCT00165139|Drug|Carboplatin|Described under detailed description
16361406|NCT00165139|Drug|Melphalan|Described under detailed description
16361407|NCT00165139|Drug|Ifosfamide|Described under detailed description
16361408|NCT00165139|Drug|G-CSF (granulocyte-colony stimulating factor)|Described under detailed description
16361409|NCT00165139|Drug|Mesna|Described under detailed description
16361410|NCT00165126|Procedure|Radiation therapy|Given as standard therapy
16361411|NCT00165100|Procedure|Dynamic Area Telethermometry (DAT)|
16361412|NCT00165087|Drug|asparaginase (E. Coli)|
16361413|NCT00165087|Drug|asparaginase (Erwina)|
16361414|NCT00165087|Drug|dexrazoxane|
16361415|NCT00165087|Drug|doxorubicin|
16361416|NCT00165087|Procedure|cranial radiation (once daily fractionation)|
16361417|NCT00165087|Procedure|cranial radiation (twice-daily fractionation)|
16361418|NCT00165087|Procedure|Intrathecal chemotherapy without radiation|
16361419|NCT00165074|Drug|Infasurf (drug)|Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses
16361420|NCT00165061|Procedure|Esophagectomy|
16361421|NCT00165061|Procedure|Chemoradiation|
16361422|NCT00165048|Drug|Vioxx (Rofecoxib)|
16361423|NCT00165035|Device|CoStar Paclitaxel Drug Eluting Coronary Stent System|Drug eluting stent
16361424|NCT00165035|Device|TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent|Drug eluting stent
16361425|NCT00165009|Device|Resolution clip (endo-clipping device)|Resolution clip (endo-clipping device)
16361426|NCT00164996|Procedure|Local pharyngeal anaesthesia|
16361427|NCT00164996|Device|Ultrathin endoscope|
16361428|NCT00164970|Dietary Supplement|Vitamin B12|
16361429|NCT00164970|Dietary Supplement|folate|
16361430|NCT00164957|Device|continuous pump feeding|
16361431|NCT00164957|Other|intermittent bolus feeding|
16361432|NCT00164944|Procedure|Colonoscopy|To determine the adenomas during colonoscopy
16361433|NCT00164944|Procedure|Colonoscopy|To determine the adenomas during colonoscopy
16361434|NCT00164931|Drug|Intravenous omeprazole infusion|
16361435|NCT00164931|Procedure|Scheduled second endoscopy|
16361436|NCT00164918|Device|nasogastric tube|
16361437|NCT00164905|Device|Doppler ultrasound probe|Applying to ulcer base to assess the blood flow underneath the ulcer
16361438|NCT00164892|Drug|Oral Vioxx (Rofecoxib)|
16361439|NCT00164879|Procedure|Endoscopic stenting followed by elective laparoscopic resection|
16361440|NCT00164866|Drug|Omeprazole|
16361441|NCT00164853|Procedure|endoscopic balloon dilatation|Refer to description under arms
16361442|NCT00164853|Procedure|Standard sphincterotomy|Refer to under arms
16361443|NCT00164840|Drug|Esomeprazole|
16361444|NCT00164827|Device|Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer|
16361445|NCT00164801|Drug|Baclofen, Diltiazem|
16361446|NCT00164788|Drug|Intravenous bolus injection of esomeprazole|80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
16361447|NCT00164788|Drug|Oral esomeprazole|40mg every 12 hours for 24 hours
16361448|NCT00164775|Drug|Imipramine|25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks
16361449|NCT00164775|Drug|Placebo|One tab nocte for first 2 weeks then 2 tabs for 10 weeks
16361450|NCT00164749|Drug|Placebo and ginkgo extract|Placebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
16361451|NCT00164749|Drug|Curcumin and ginkgo extract|1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
16361452|NCT00164749|Drug|Curcumin and ginkgo extract|4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
16361453|NCT00164736|Drug|Maternal zidovudine/lamivudine/lopinavir-ritonavir|Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
16361454|NCT00164736|Drug|Infant nevirapine|"Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.
~To 28 weeks while breastfeeding."
16361455|NCT00164736|Dietary Supplement|Maternal protein and calorie supplement|High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
16361456|NCT00164723|Procedure|Capsule endoscopy|Capsule endoscopy and colonoscopy
16361457|NCT00164710|Drug|sulfadoxine-pyrimethamine|
16361458|NCT00164710|Drug|amodiaquine plus sulfadoxine-pyrimethamine|
16361459|NCT00164710|Drug|amodiaquine plus artesunate|
16361460|NCT00164710|Drug|chlorproguanil-dapsone plus artesunate|
16361461|NCT00164710|Drug|lumefantrine-artemether|
16361462|NCT00164697|Behavioral|Parenting group|Weekly and periodic (10 weeks blocks with 6 week break) parenting group meetings (2.5-3 hr), periodic one-on-one meetings (2 hr), visits to community resources (2-3 hr per event). Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events.
16361463|NCT00164684|Behavioral|Father Friendly Initiative|
16361464|NCT00164671|Behavioral|POWER|
16361465|NCT00164658|Behavioral|Familial risk assessment and personalized prevention messages|
16361466|NCT00164645|Behavioral|Problem Solving intervention|
16361467|NCT00164632|Behavioral|counselling, exercise, referrals (behavior)|
16361468|NCT00164619|Behavioral|VOICES/VOCES|45-minute intervention for small groups of African American and Hispanic heterosexual men and women. Group members are same gender and race/ethnicity. View culturally-specific condom promotion video. Facilitated group discussion to build skills in condom use and condom negotiation. Education on condom varieties to overcome participants' personal barriers to condoms use. Distribution of 3 specialty condoms of participant's choice (i.e., different sizes, textures, thicknesses, lubrication, material). [see Brief Summary above]
16361469|NCT00164619|Biological|Standard STD clinic services|Individual physical exam, STD/HIV tests, treatment as indicated
16361470|NCT00164606|Behavioral|Positive Parenting Program (Triple-P)|
16361471|NCT00164593|Behavioral|Youth Empowerment Solutions for Peaceful Communities|YES is a multi-faceted program that (1) engages 7th and 8th graders in a youth development program, (2) enhances neighborhood organizations' ability to include youth in their activities, and (3) connects the youth participants and adults in neighborhood organizations (e.g., crime watches, block groups, neighborhood associations) to carry out neighborhood improvement activities (e.g., community gardens, parks cleanup).
16361472|NCT00164580|Behavioral|Community-Level Intervention|
16361473|NCT00164567|Behavioral|Onsite IPV specialist|
16361474|NCT00164567|Behavioral|Empowerment focused intervention|
16361475|NCT00164554|Behavioral|Parent-child Interaction Therapy (PCIT)|
16361476|NCT00164541|Behavioral|Arts Based Program|
16361477|NCT00164541|Behavioral|Curriculum|
16361478|NCT00164528|Behavioral|Positive Behavior Support|
16361479|NCT00164515|Behavioral|Personalized exercise programme (PEP)|Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
16361480|NCT00164502|Behavioral|Community-based eight session group self-management program|
16361481|NCT00164489|Behavioral|Weight control and physical activity promotion|
16361482|NCT00164476|Behavioral|Preventive Services Prevention Kit|
16361483|NCT00164476|Behavioral|peer mentors (control group)|
16361484|NCT00164463|Drug|Moxifloxacin|400 mg po qd 5/7 days per week
16361485|NCT00164463|Drug|Isoniazid|isoniazid 300 mg po qd 5/7 days per week
16361486|NCT00164450|Drug|Rifapentine + isoniazid once weekly for 3 months|
16361487|NCT00164437|Behavioral|educational CD-ROM|
16361488|NCT00164424|Drug|Acyclovir|
16361489|NCT00164411|Biological|Tetanus-diphtheria toxoids (Td)|
16361490|NCT00164411|Biological|7-valent pneumococcal conjugate vaccine|
16361491|NCT00164411|Biological|23-valent polysaccharide vaccine|
16361492|NCT00164398|Behavioral|HIP: HIV Intervention for Providers|
16361493|NCT00164385|Behavioral|Adolescent Impact|
16361494|NCT00164372|Behavioral|Peer Education Intervention|
16361495|NCT00164359|Drug|Amodiaquine plus artesunate|
16361496|NCT00164359|Drug|chlorproguanil-dapsone plus artesunate|
16361497|NCT00164346|Behavioral|neurocognitive habilitation|
16361498|NCT00164333|Behavioral|TAP: Treatment Advocacy Program|
16361499|NCT00164320|Behavioral|TEAM|
16361500|NCT00164307|Behavioral|Parent assisted social skills training|
16361501|NCT00164294|Behavioral|Brief intervention|
16361502|NCT00164281|Drug|Isoniazid|Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
16361503|NCT00164268|Behavioral|Ke Ala Lokahi (Native Hawaiian cultural intervention)|
16361504|NCT00164255|Drug|sulfadoxine/pyrimethamine|
16361505|NCT00164255|Drug|sulfadoxine/pyrimethamine plus artesunate|
16361506|NCT00164242|Drug|Galantamine|
16361507|NCT00164229|Behavioral|math|
16361508|NCT00164229|Behavioral|behavior regulation|
16361509|NCT00164216|Drug|mefloquine plus artesunate|
16361510|NCT00164203|Behavioral|Cognitive Behavioral Therapy|12-session, weekly, school-based protocol based on cognitive restructuring, tailored to children Grades 3 to 6; comparison with activity control condition of equal duration.
16361511|NCT00164203|Behavioral|School-based CBT|12 sessions, weekly
16361512|NCT00164203|Behavioral|activity control condition|weekly games & activities x 12 weeks
16361513|NCT00164190|Procedure|Routine Early Percutaneous Coronary Intervention after Thrombolysis|early or delayed PCI
16361514|NCT00164177|Drug|HalfLytely|
16361515|NCT00164164|Drug|HalfLytely|
16361516|NCT00164164|Drug|NuLytely|
16361517|NCT00164151|Drug|HalfLytely|
16361518|NCT00164151|Drug|Visicol|
16361519|NCT00164138|Procedure|Pelvic floor training group|pelvic floor training, electrotherapy, bladder retraining.
16361520|NCT00164125|Drug|polyethyleneglycol3350|
16361521|NCT00164112|Drug|Cooperstown 5+1 alone|
16361522|NCT00164112|Drug|Azithromycin plus Cooperstown 5+1|
16361523|NCT00164112|Drug|Telithromycin plus Cooperstown 5+1|
16361524|NCT00164112|Drug|Levofloxacin plus Cooperstown 5+1|
16361525|NCT00164099|Drug|Synbiotic 2000|See protocol - 4 bacteria, 4 fiber mixture
16361526|NCT00164086|Drug|atorvastatin|
16361527|NCT00164073|Procedure|Liver biopsy|
16361528|NCT00164047|Drug|Nitrous Oxide|
16361529|NCT00164034|Device|Real time computer prompted trauma algorithms|
16361530|NCT00164021|Procedure|Physiotherapy, exercise, percutaneous gastrostomy feeds|
16361531|NCT00164021|Drug|Anti-reflux pharmacotherapy|
16361532|NCT00164008|Drug|zoledronic acid vs pamidronate|
16361533|NCT00163995|Drug|urotensin II|
16361534|NCT00163982|Drug|Norfloxacin|
16361535|NCT00163969|Drug|ketamine|
16361536|NCT00163943|Behavioral|Dietary weight loss +/- aerobic exercise|
16361537|NCT00163917|Device|Virtual reality relaxation|
16361538|NCT00163904|Behavioral|High mono-unsaturated fat/low carbohydrate diet|
16361539|NCT00163904|Behavioral|High carbohydrate/low fat diet|
16361540|NCT00163891|Behavioral|Chest physiotherapy|
16361541|NCT00163878|Procedure|Sensory Stimulation|
16361542|NCT00163878|Device|Sesnory Modality Assessment and Rehabilitation Technique|
16361543|NCT00163852|Drug|Normal saline IV, salt tablets|
16361544|NCT00163839|Behavioral|Dietary Therapy|
16361545|NCT00163813|Procedure|Early jejunal feeding (using frictional NJ tube)|
16361546|NCT00163813|Procedure|Standard feeding (using nasogastric [NG] tube)|
16361547|NCT00163787|Behavioral|outcome measures and self report|
16361548|NCT00163774|Device|Brain oxygenation and microdialysis catheters|
16361549|NCT00163761|Drug|gemcitabine, vinorelbine, ifosfamide, filgastrim|Drug
16361550|NCT00163761|Drug|gemcitabine, vinorelbine, filgastrim|Drug
16361551|NCT00163748|Drug|gemcitabine, vinorelbine|
16361552|NCT00163735|Drug|Administration of wine fined with potential food allergens|
16361553|NCT00163722|Other|Culture and histology|
16361554|NCT00163722|Other|Aspergillus galactomannan and PCR|
16361555|NCT00163709|Procedure|BNP test|
16361556|NCT00163683|Behavioral|Dietary Therapy|
16361557|NCT00163657|Drug|Daclizumub|anti-rejection drug
16361558|NCT00163657|Drug|Tacrolimus|anti rejection drug
16361559|NCT00163657|Drug|Cyclosporine|anti rejection drug
16361560|NCT00163657|Drug|MMF|anti rejection drug
16361561|NCT00163644|Procedure|aereobic plus resisted exercise|
16361562|NCT00163644|Procedure|aerobic plus active exercise|
16361563|NCT00163644|Other|No formal exercise plus phone calls|
16361564|NCT00163618|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
16361565|NCT00163605|Device|Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)|
16361566|NCT00163592|Drug|Tissucol®|
16361567|NCT00163592|Procedure|Control: Conventional treatment, i.e. compression with swabs|
16361568|NCT00163579|Drug|Bryophyllum|
16361569|NCT00163579|Other|Placebo|
16361570|NCT00163566|Drug|Dihydrotestosterone (0.7%) in hydroalcoholic gel|transdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day
16361571|NCT00163553|Drug|Pethidine|
16361572|NCT00163553|Drug|Placebo|
16361573|NCT00163540|Biological|Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|
16361574|NCT00163527|Drug|Roflumilast|
16361575|NCT00163514|Drug|Ciclesonide|
16361576|NCT00163501|Drug|Ciclesonide|
16361577|NCT00163488|Drug|Ciclesonide|
16361578|NCT00163475|Drug|Roflumilast|
16361579|NCT00163462|Drug|Ciclesonide|
16361580|NCT00163449|Drug|Ciclesonide|Efficacy and Safety of Ciclesonide
16361581|NCT00163449|Drug|Placebo|Placebo
16361582|NCT00163436|Drug|Ciclesonide|
16361583|NCT00163423|Drug|Ciclesonide|
16361584|NCT00163410|Drug|Ciclesonide|
16361585|NCT00163397|Drug|Ciclesonide|
16361586|NCT00163384|Drug|Ciclesonide|
16361587|NCT00163371|Drug|Ciclesonide|
16361588|NCT00163358|Drug|Ciclesonide|
16361589|NCT00163345|Drug|Ciclesonide|
16361590|NCT00163332|Drug|Ciclesonide|
16361591|NCT00163319|Drug|Ciclesonide|
16361592|NCT00163306|Drug|Pantoprazole|
16361593|NCT00163293|Drug|Ciclesonide|Ciclesonide metered-dose inhaler
16361594|NCT00163293|Drug|Placebo|Ciclesonide placebo-matching metered-dose inhaler
16361595|NCT00163280|Drug|ATL-104|Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.
16361596|NCT00163267|Drug|clopidogrel|Best endovascular treatment either with one or the other drug arm should be investigated
16361597|NCT00163254|Drug|abciximab|
16361598|NCT00163254|Device|stent and drug eluting stent|
16361599|NCT00163241|Drug|celecoxib|
16361600|NCT00163215|Drug|Somatropin|Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
16361601|NCT00163202|Procedure|Blood samples|
16361602|NCT00163202|Drug|Atorvastatin|
16361603|NCT00163189|Drug|Somatropin|Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
16361604|NCT00163163|Procedure|Echographic measurements|
16361605|NCT00163163|Procedure|Blood samples|
16361606|NCT00163150|Drug|Atorvastatin|
16361607|NCT00163137|Drug|lasofoxifene|lasofoxifene 0.25mg
16361608|NCT00163137|Drug|raloxifene|raloxifene 60 mg/day
16361609|NCT00163137|Drug|Placebo|0 mg/day
16361610|NCT00163124|Procedure|spinal manipulation & patient education/nutrition|
16361611|NCT00163111|Drug|VFENDÂ® I.V., Oral|
16361612|NCT00163111|Drug|Conventional amphotericin B|
16361613|NCT00163111|Drug|Diflucan IV, oral|
16361614|NCT00163098|Drug|UK-369,003|
16361615|NCT00163085|Drug|NR2B NMDA Antagonist CP-101,606 (traxoprodil)|
16361616|NCT00163072|Drug|transdermal Megace|oral vs transdermal levels
16361617|NCT00163059|Drug|NMDA Antagonist, CP-101,606 (traxoprodil)|
16361618|NCT00163046|Drug|Gabapentin|Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
16361619|NCT00163046|Drug|Placebo|Matched placebo 30 minutes prior to bedtime for 28 days
16361620|NCT00163033|Drug|estetrol|
16361621|NCT00163020|Drug|17-alpha-hydroxyprogesterone caproate injectable|250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.
16361622|NCT00163020|Drug|Placebo|Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
16361623|NCT00163007|Procedure|Nutritional support|
16361624|NCT00162994|Procedure|adenoidectomy and tymapanostomy|
16361625|NCT00162981|Drug|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
16361626|NCT00162981|Drug|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
16361627|NCT00162968|Drug|escitalopram|
16361628|NCT00162955|Drug|Valsartan|Patients allocated into ARB administration group take Valsartan (80mg/day) from the day of the start of 1st CHOP until the completion of all the evaluations.
16361629|NCT00162942|Device|Adacolumn|"Ten apheresis sessions:
~One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9)."
16361630|NCT00162942|Device|Sham|Sham, ten apheresis sessions within 9 weeks
16361631|NCT00162929|Biological|AdHer-2/neu transduced dendritic cells|Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site)
16361632|NCT00162916|Drug|citalopram|20mg or 40mg, once daily, for 40 weeks
16361633|NCT00162916|Drug|Placebo|Cornstarch
16361634|NCT00162890|Behavioral|Therapeutic exercise|
16361635|NCT00162877|Drug|Rabeprazole vs. Esomeprazole|
16361636|NCT00162864|Drug|montelukast sodium|
16361637|NCT00162851|Drug|alemtuzumab|
16361638|NCT00162812|Drug|Epirubicin|100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)
16361639|NCT00162799|Drug|Triflusal (DCI)|
16361640|NCT00162786|Drug|Rupatadine|
16361641|NCT00162786|Drug|Hydroxyzine|
16361642|NCT00162786|Drug|Placebo|
16361643|NCT00162773|Drug|omalizumab|150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.
16361644|NCT00162773|Other|Placebo|150-375 milligrams depending on body weight and serum IgE.
16361645|NCT00162760|Drug|Thalidomide|
16361646|NCT00162747|Drug|Aquaphor|
16361647|NCT00162747|Drug|Sunflower Seed Oil|
16361648|NCT00162734|Drug|Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks|
16361649|NCT00162721|Drug|doxorubicin, ifosfamide, cisplatin|
16361650|NCT00162708|Procedure|Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)|
16361651|NCT00162708|Procedure|Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)|
16361652|NCT00162708|Drug|CDDP, 5 Fu|
16361653|NCT00162695|Drug|Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide|
16361654|NCT00162682|Procedure|Antiretroviral Drug Combination Switching Criteria|Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
16361655|NCT00162682|Procedure|Antiretroviral Drug Combination Switching Criteria|Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
16361656|NCT00162669|Drug|bevacizumab|
16361657|NCT00162656|Drug|half cyclophosphamide|
16361658|NCT00162656|Drug|without COPADM3|
16361659|NCT00162656|Drug|mini CYVE, without 3 maintenance courses|
16361660|NCT00162656|Drug|LMB B|
16361661|NCT00162656|Drug|LMB C|
16361662|NCT00162643|Drug|zidovudine+lamivudine+lopinavir/ritonavir|
16361663|NCT00162643|Drug|zidovudine + lamivudine + efavirenz|
16361664|NCT00162630|Procedure|Fascia Iliaca Compartment Blockade|
16361665|NCT00162617|Drug|Red blood cell transfusion|
16361666|NCT00162604|Drug|Cefuroxime|
16361667|NCT00162591|Drug|remifentanyl|
16361668|NCT00162565|Drug|beta-blocker treatment|beta-blocker treatment
16361669|NCT00162552|Drug|pentoxifylline|Patients with severe cirrhosis treated with Pentoxifylline
16361670|NCT00162552|Drug|PLACEBO|Patients with severe cirrhosis treated with a placebo
16361671|NCT00162539|Other|echography|Correlation of neonatal thyroid volume with maternal iodine deficiency
16361672|NCT00162526|Drug|Tocopherol|
16361673|NCT00162513|Biological|Allogeneic tumor cell vaccine|
16361674|NCT00162500|Biological|Peptide Vaccine (MUC-1)|
16361675|NCT00162487|Drug|Albuterol (1,200 μg) through metered-dose inhaler|
16361676|NCT00162474|Drug|Warfarin|
16361677|NCT00162474|Drug|Phenytoin|
16361678|NCT00162461|Drug|Phenytoin single dose (300 mg)|
16361679|NCT00162448|Drug|BMS-394136|Oral Solution, Oral, 100 mg, Single dose, 1 day.
16361680|NCT00162448|Drug|Placebo|Oral Solution, Oral, 0 mg, Single dose, 1 day.
16361681|NCT00162435|Drug|Warfarin|
16361682|NCT00162422|Drug|albuterol|
16361683|NCT00162409|Drug|Folic acid|
16361684|NCT00162396|Drug|Albuterol|
16361685|NCT00162383|Drug|Debrisoquine|
16361686|NCT00162383|Drug|Mephenytoin|
16361687|NCT00162383|Drug|Dapsone|
16361688|NCT00162383|Drug|Caffeine|
16361689|NCT00162370|Drug|Perflutren Lipid Microsphere Injectable Suspension|Activated DEFINITY 10ug/kg by bolus injection
16361690|NCT00162357|Drug|Technetium Tc99m Sestamibi|
16361691|NCT00162344|Drug|Technetium Tc99m Sestamibi|
16361692|NCT00162331|Drug|Technetium Tc99m Sestamibi|
16361693|NCT00162318|Drug|Cetuximab + Gefitinib|IV solution + tablet, IV + oral, ERB (100 mg/m2, 200 mg/m2 + 250 mg/m2 IV) +GEF 250 mg tablet, ERB weekly/ GEF once daily, Until disease progression.
16361694|NCT00162305|Drug|BMS-512148|Capsules, Oral, 100 mg, Once daily, 14 days.
16361695|NCT00162305|Drug|BMS-512148|Capsules, Oral, 25 mg, Once daily, 14 days.
16361696|NCT00162305|Drug|BMS-512148|Capsules, Oral, 5 mg, Once daily, 14 days.
16361697|NCT00162305|Drug|Placebo|Capsules, Oral, 0 mg, Once daily, 14 days.
16361698|NCT00162292|Drug|BMS-582949 and Methotrexate|
16361699|NCT00162279|Drug|Abatacept|
16361700|NCT00162266|Drug|Abatacept (BMS-188667)|IV, 10 mg/Kg, monthly, for the duration of the trial
16361701|NCT00162266|Drug|Abatacept (BMS-188667)|Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
16361702|NCT00162266|Drug|Abatacept (BMS-188667)|Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
16361703|NCT00162266|Drug|Placebo|Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
16361704|NCT00162253|Drug|BMS 587101|
16361705|NCT00162240|Drug|Muraglitazar|
16361706|NCT00162227|Drug|Efavirenz|Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
16361707|NCT00162214|Drug|Dasatinib + Ketoconazole|Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity.
16361708|NCT00162201|Drug|Abatacept|Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
16361709|NCT00162188|Drug|Efavirenz|Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
16361710|NCT00162175|Drug|Muraglitazar|
16361711|NCT00162149|Drug|Nevirapine|Tablets, Oral, 200 mg, Twice daily, 3 days.
16361712|NCT00162149|Drug|Nevirapine + Atazanavir/Ritonavir|Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
16361713|NCT00162149|Drug|Nevirapine + Atazanavir/Ritonavir|Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
16361714|NCT00162149|Drug|Atazanavir + Ritonavir|Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
16361715|NCT00162136|Drug|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
16361716|NCT00162123|Drug|Ipilimumab|Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
16361717|NCT00162110|Drug|cetuximab|mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
16361718|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
16361719|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
16361720|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
16361721|NCT00162097|Drug|efavirenz containing antiretroviral regimen|Capsule or Tablet, Oral, once daily for 2 days
16361722|NCT00162084|Drug|apadenoson|
16361723|NCT00162071|Drug|apadenoson|
16361724|NCT00162058|Drug|Peflutren Lipid Microsphere Injectable Suspension|
16361725|NCT00162045|Drug|Technetium Tc99m Sestamibi|Rest and/or stress SPECT imaging study
16361726|NCT00162032|Drug|Sestamibi|Sestamibi
16361727|NCT00162019|Drug|Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)|
16361728|NCT00162006|Drug|Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution|
16361729|NCT00161993|Drug|Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution|
16361730|NCT00161993|Drug|Gammagard S/D (Solvent/Detergent)|
16361731|NCT00161980|Drug|Fibrin Sealant VH S/D|
16361732|NCT00161980|Procedure|Surgical intervention alone without Fibrin Sealant VH S/D application|
16361733|NCT00161967|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
16361734|NCT00161954|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361735|NCT00161928|Biological|Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)|
16361736|NCT00161915|Drug|Fibrin Sealant|
16361737|NCT00161902|Drug|Fibrin Sealant Vapor-Heated Solvent/Detergent-treated|
16361738|NCT00161889|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361739|NCT00161876|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361740|NCT00161863|Biological|FSME-IMMUN NEW 0.25 ml|
16361741|NCT00161850|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361742|NCT00161837|Biological|Vero Cell-derived Influenza Vaccine|
16361743|NCT00161837|Biological|Egg-derived Influenza Vaccine|
16361744|NCT00161824|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361745|NCT00161811|Biological|Vero Cell-derived Influenza Vaccine|
16361746|NCT00161811|Biological|Egg cell-derived Influenza Vaccine|
16361747|NCT00161798|Biological|Tick-borne encephalitis vaccine|
16361748|NCT00161785|Biological|FSME-IMMUN 0.5ml|
16361749|NCT00161772|Biological|Tick-borne Encephalitis Vaccine|
16361750|NCT00161759|Drug|Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin|
16361751|NCT00161746|Biological|Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|
16361752|NCT00161733|Drug|Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)|
16361753|NCT00161733|Drug|TISSEEL VH fibrin sealant|
16361754|NCT00161720|Drug|Protein C Concentrate (Human) Vapor Heated|Protein C Concentrate (Human) Vapor Heated
16361755|NCT00161707|Drug|Aerosolized, Recombinant Alpha 1-Antitrypsin|
16361756|NCT00161694|Dietary Supplement|sucrose solution|
16361757|NCT00161681|Drug|Levonorgestrel/Ethinyl Estradiol|
16361758|NCT00161668|Drug|Mylotarg|
16361759|NCT00161655|Drug|Etanercept|
16361760|NCT00161655|Drug|Methotrexate|
16361761|NCT00161642|Drug|CMD-193|
16361762|NCT00161629|Drug|rhBMP-2/CPM|
16361763|NCT00161616|Drug|InductOs|InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
16361764|NCT00161603|Behavioral|Semi-structured, open-ended interviews|
16361765|NCT00161590|Drug|CHOP and alemtuzumab|
16361766|NCT00161577|Drug|Ketorolac|Intravenous ketorolac every 6 hours for 24 hours
16361767|NCT00161577|Other|Placebo|Placebo Comparator
16361768|NCT00161564|Drug|Rituximab|
16361769|NCT00161551|Device|Vitatron T70 DR|
16361770|NCT00161538|Device|Pacing leads to be implanted according randomization.|
16361771|NCT00161538|Device|Selection 9000 prevent AF an Diagnose AF|
16361772|NCT00161525|Procedure|Pneumatic displacement|Pneumatic displacement of the subretinal hemorrhages is attempted with an intravitreous injection of 0.4 ml of pure C2F6 or 2 injections of 0.2 ml on subsequent days. The gas is withdrawn from a laboratory cylinder through a millipore filter and injected into the eye through a 30 gauge needle inserted 4.0 mm posterior to the limbus in the superior temporal quadrant. The tip of the needle is monitored in the vitreous by indirect ophthalmology prior to injecting the gas.Post injections the central retinal artery is examined whether is patent.The intraocular gas expands 3.3 times over the next 3 days to create a 40% bubble.The patient is asked to assume a gaze position 40° below the horizontal for 20 minutes every hour while awake and to sleep on 2 pillows with his head turned to the right.
16361773|NCT00161486|Drug|Testosterone gel|Testosterone gel 100 mg daily for 4 weeks
16361774|NCT00161486|Drug|Acyline|Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
16361775|NCT00161486|Drug|Placebo acyline|Placebo acyline injections every two weeks (2 doses)
16361776|NCT00161486|Drug|Placebo Testosterone gel|placebo testosterone gel daily for 4 weeks
16361777|NCT00161473|Drug|prazosin|"Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
~Duration was 8 weeks."
16361778|NCT00161473|Drug|placebo (inert substance)|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
16361779|NCT00161460|Behavioral|colorectal cancer screening intervention|Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
16361780|NCT00161447|Drug|Acyline|Acyline 300 mcg/kg SQ every 2 weeks for 12 weeks
16361781|NCT00161447|Drug|Testosterone Gel|Testosterone Gel (10 g daily
16361782|NCT00161447|Drug|Depo-Medroxyprogesterone|DMPA (injected into muscle) Day 0 & month 3
16361783|NCT00161434|Drug|valacyclovir|1 gram daily for 8 weeks
16361784|NCT00161434|Drug|placebo|matching placebo for 8 weeks
16361785|NCT00161421|Drug|Oral Testosterone|200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food
16361786|NCT00161421|Drug|Leuprolide (Lupron)|7.5 mg injection into muscle (once) (Day -14)
16361787|NCT00161421|Drug|Dutasteride|24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)
16361788|NCT00161408|Behavioral|cognitive behavioural therapy|
16361789|NCT00161408|Behavioral|psychoeducation|
16361790|NCT00161395|Behavioral|Instruction in the Creighton Model Fertility Care System|Instruction in the Creighton Model Fertility Care System.
16361791|NCT00161395|Behavioral|Preconception advice|Preconception advice for diet and frequency of intercourse.
16361792|NCT00161382|Behavioral|HIV, STD, and pregnancy prevention curriculum|"This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
16361793|NCT00161382|Behavioral|Standard sexual education curriculum|Control curriculum consists of standard sexual education.
16361794|NCT00161356|Drug|Ambisome|5mg/kg IV - one time dose during liver transplant
16361795|NCT00161356|Procedure|Liver Biopsy|post drug delivery (60 min. after completion of Ambisome infusion)
16361796|NCT00161343|Behavioral|Health Improvement Project for Teens on HIV Prevention|Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
16361797|NCT00161330|Drug|oral amoxicilline/clavulanic acid|
16361798|NCT00161330|Drug|iv ceftriaxone|
16361799|NCT00161317|Behavioral|Living with Hope Program|
16361800|NCT00161304|Drug|Testosterone Enanthate|Testosterone Enanthate
16361801|NCT00161304|Other|Placebo|placebo
16361802|NCT00161291|Drug|Letrozole in combination with Bevacizumab|Patients will be administered Letrozole at 2.5 mg PO a day and Avastin at 15 mg/kg IV every 3 weeks for 24 weeks. Patients will then undergo surgical treatment and receive adjuvant therapy according to the treating physician.
16361803|NCT00161278|Drug|Carboplatin|
16361804|NCT00161278|Drug|Paclitaxel|
16361805|NCT00161278|Procedure|Gene expression profiling (analysis) of tumor samples|
16361806|NCT00161265|Procedure|tissue procurement|tissue procurement
16361807|NCT00161239|Drug|Doxil, Methotrexate, L-Asparaginase, Prednisone|
16361808|NCT00161226|Device|Levonorgestrel intrauterine system|
16361809|NCT00161213|Drug|gemcitabine hydrochloride|
16361810|NCT00161213|Drug|imatinib mesylate|
16361811|NCT00161200|Drug|Ranitidine & Pantoprazole|
16361812|NCT00161187|Biological|therapeutic allogeneic lymphocytes|The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
16361813|NCT00161148|Drug|Probiotics|
16361814|NCT00161122|Biological|trivalent inactivated influenza vaccine|
16361815|NCT00161122|Biological|combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine|
16361816|NCT00161096|Drug|pantoprazole 20 mg (drug)|
16361817|NCT00161083|Drug|ursodeoxycholic acid|
16361818|NCT00161070|Drug|anticoagulation|
16361819|NCT00161070|Drug|aspirin and dipyridamole|
16361820|NCT00161070|Drug|aspirin alone|
16361821|NCT00161044|Drug|Galantamine|
16361822|NCT00161031|Drug|Atomoxetine|
16361823|NCT00161018|Drug|Quetiapine, Risperidone, Fluphenazine|
16361824|NCT00161005|Procedure|PCI|Immediate transport to invasive center after thrombolysis
16361825|NCT00160992|Biological|Melan-A analog peptide|
16361826|NCT00160979|Procedure|Pre-treatment tumour oxygen measurements|Pre-treatment tumour oxygen measurements
16361827|NCT00160966|Drug|Ciclosporin and Mycophenolate-mofetil|according to the Giessen protocol
16361828|NCT00160966|Drug|Tacrolimus and Mycophenolate-mofetil|according to Giessen protocol
16361829|NCT00160966|Drug|Tacrolimus and Mycophenolate-mofetil with change from Mycophenolate-mofetil to Everolimus|according to Giessen protocol
16361830|NCT00160953|Procedure|Endorectal Coil Magnetic Resonance Images|
16361831|NCT00160927|Device|local heating|
16361832|NCT00160927|Device|iontophoresis|
16361833|NCT00160927|Drug|actylcholine|
16361834|NCT00160927|Drug|sodium nitroprusside|
16361835|NCT00160914|Behavioral|Identification/management of childhood obesity (behavior)|In this project, we plan to conduct a national survey of pediatricians to assess common strategies for identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity.
16361836|NCT00160901|Drug|two complex naturopathic add-on therapies, leaflet 5-a-day|
16361837|NCT00160888|Drug|sodium nitroprusside, bradykinin, acetylcholine|
16361838|NCT00160875|Drug|Irinotecan hydrochloride trihydrate|Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8
16361839|NCT00160875|Drug|Cisplatin|Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8
16361840|NCT00160862|Drug|SLV317|
16361841|NCT00160849|Drug|Lopinavir/r|
16361842|NCT00160836|Device|"Tissue sampling (G.I.U.M. catheter)"|
16361843|NCT00160823|Procedure|Self-administered leaflet|
16361844|NCT00160797|Device|MIS™ Minimally Invasive Solutions™ TKA System|
16361845|NCT00160784|Procedure|Arthroscopy|Randomized placement into 2 groups; arthroscopic manipulation or home therapy
16361846|NCT00160784|Procedure|Arthroscopic manipulation|Manipulation of shoulder performed during arthroscopy
16361847|NCT00160784|Other|Home therapy|Shoulder exercise program performed at home that may increase shoulder function
16361848|NCT00160771|Behavioral|Joint Motion Analysis|Joint motion will be recorded for analysis.
16361849|NCT00160758|Procedure|retrieve massive allograft|Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing
16361850|NCT00160745|Drug|Rosuvastatin|
16361851|NCT00160732|Drug|Allogenic islet cells (human, U. Chicago)|Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
16361852|NCT00160732|Procedure|Intraportal infusion of islet cells|Intraportal infusion of islet cell through the portal vein in the liver.
16361853|NCT00160719|Procedure|retrieve blood samples|blood samples obtain pre-op, 6 and 12 months post-op
16361854|NCT00160706|Biological|Certolizumab Pegol (CDP870)|"Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
~Up to 84 months of therapy in this study."
16369510|NCT00100243|Drug|Plenaxis|
16361855|NCT00160693|Biological|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
16361856|NCT00160680|Drug|Levocetirizine|"Pharmaceutical form: Tablet
~Concentration: 5 mg
~Route of administration: Oral use"
16361857|NCT00160667|Drug|Placebo|Daily oral dose of two equal intakes.
16361858|NCT00160667|Drug|Brivaracetam|Daily oral dose of two equal intakes.
16361859|NCT00160654|Drug|Levetiracetam|"Pharmaceutical form: oral tablets
~Concentration: 500 mg
~Route of administration: Oral use"
16361860|NCT00160641|Biological|Certolizumab Pegol|"Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
~Duration: Until end of study."
16361861|NCT00160628|Drug|Levetiracetam|
16361862|NCT00160615|Drug|Levetiracetam|"Pharmaceutical form: Film-coating tablets
~Concentration: 250 mg/ 500 mg
~Route of administration: oral use"
16361863|NCT00160602|Drug|Certolizumab Pegol|
16361864|NCT00160589|Drug|Levocetirizine|
16361865|NCT00160576|Drug|Levetiracetam|
16361866|NCT00160563|Drug|LEVOCETIRIZINE|5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months
16361867|NCT00160563|Other|Placebo|Oral drops, bid for 18 months
16361868|NCT00160550|Drug|Levetiracetam|
16361869|NCT00160537|Drug|Levocetirizine|
16361870|NCT00160524|Biological|Certolizumab Pegol (CDP870)|Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
16361871|NCT00160511|Drug|Levetiracetam|
16361872|NCT00160498|Drug|Lercanidipine|
16361873|NCT00160485|Drug|Glyburide|dosage required to obtain adequate glucose control
16361874|NCT00160485|Drug|Insulin|variable dosage to obtain glucose control
16361875|NCT00160472|Procedure|removal of ovarian vessels|
16361876|NCT00160459|Drug|Asoprisnil|5 mg Tablet, oral Daily for 12 weeks
16361877|NCT00160459|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 weeks
16361878|NCT00160459|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 weeks
16361879|NCT00160459|Drug|Placebo|Tablet, oral Daily for 12 weeks
16361880|NCT00160446|Drug|Asoprisnil|5mg Tablet, oral Daily for 12 weeks
16361881|NCT00160446|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 weeks
16361882|NCT00160446|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 weeks
16361883|NCT00160446|Drug|Placebo|Tablet, oral Daily for 12 weeks
16361884|NCT00160433|Drug|Asoprisnil|0.5 mg Tablet, oral Daily for 12 weeks
16361885|NCT00160433|Drug|Asoprisnil|1.5 mg Tablet, oral Daily for 12 weeks
16361886|NCT00160433|Drug|Asoprisnil|5.0 mg Tablet, oral Daily for 12 weeks
16361887|NCT00160433|Drug|Placebo|Tablet, oral Daily for 12 weeks
16361888|NCT00160420|Drug|Asoprisnil|5mg Tablet, oral Daily for 12 months
16361889|NCT00160407|Drug|Orlistat (Xenical)|
16361890|NCT00160407|Behavioral|1400 kcal diet (30% fat)|
16361891|NCT00160394|Drug|Duac® Gel / Differin® Gel|
16361892|NCT00160381|Drug|Asoprisnil|10mg Tablet, oral Daily for 12 months
16361893|NCT00160381|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 months
16361894|NCT00160381|Drug|Placebo|Tablet, oral Daily for 12 months
16361895|NCT00160368|Behavioral|Potassium supplementation|
16361896|NCT00160355|Procedure|Hematopoietic stem cell transplantation|To determine the safety in regards to engraftment and toxicity within 100 days of infusing a haploidentical T- and B-cell depleted hematopoietic stem cell graft into patients with Wiskott-Aldrich syndrome who have received a reduced intensity conditioning regimen.
16361897|NCT00160355|Device|Miltenyi CliniMACS selection system|This system depletes the hematopoietic stem cell graft of T and B lymphocytes.
16361898|NCT00160355|Drug|Fludarabine, Melphalan, Thiotepa|Participants will receive a reduced intensity conditioning regimen consisting of Fludarabine, Melphalan, Thiotepa, and OKT3 prior to receipt of the haploidentical stem cell graft. Rituximab will be given in an effort to prevent PTLPD. In addition to T-cell depletion of the donor product, cyclosporine will be given for GVHD prophylaxis.
16361899|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
16361900|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
16361901|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
16361902|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
16361903|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE
16361904|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
16361905|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.45 EE
16361906|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, 0.60 MT
16361907|NCT00160342|Drug|Esterified Estrogens (EE) and Methyltestosterone (MT)|oral tablet, QD, 12 weeks, Placebo
16361908|NCT00160329|Drug|Atazanavir|300 mg with ritonavir boosting or 400 mg without
16361909|NCT00160316|Drug|0.5 Mg Estradiol and 2.5 Mg Dydrogesterone|p.o. daily
16361910|NCT00160303|Drug|Prolotherapy|
16361911|NCT00160303|Drug|Local Corticosteroid Therapy|
16361912|NCT00160290|Drug|Lactulose|15 mL / 12 hours
16361913|NCT00160290|Drug|Plantago ovata|3,5 g / 12 hours
16361914|NCT00160277|Drug|Moxonidine|
16361915|NCT00160264|Drug|Lactulose, Vitamin D, Calcium|
16361916|NCT00160251|Drug|Boceprevir (BOC)|100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
16361917|NCT00160251|Biological|PegIntron (PEG)|1.5 mcg/kg weekly subcutaneously
16361918|NCT00160251|Drug|Ribavirin (RBV)|200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])
16361919|NCT00160238|Drug|Betahistine 24 mg bid (Betaserc)|
16361920|NCT00160225|Drug|Daglutril|
16361921|NCT00160212|Drug|Daglutril|
16361922|NCT00160199|Drug|PROMETRIUM® 300 mg|300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
16371851|NCT00003413|Drug|cisplatin|
16361923|NCT00160199|Drug|PROMETRIUM® 400 mg|400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
16361924|NCT00160186|Drug|Pancreatin|2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)
16361925|NCT00160186|Drug|Placebo|Placebo
16361926|NCT00160173|Drug|Estradiol|
16361927|NCT00160160|Drug|eprosartan/HCTZ|
16361928|NCT00160147|Drug|bifeprunox|One week titration with dose adjustments
16361929|NCT00160147|Drug|Placebo|Placebo
16361930|NCT00160134|Drug|SLV320|
16361931|NCT00160121|Drug|Lanthanum carbonate|
16361932|NCT00160108|Behavioral|dietary intervention|
16361933|NCT00160082|Drug|Xepol|
16361934|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|16 mg/m2, 3-hour infusion, every 3 weeks
16361935|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 30-min infusion, every 3 weeks
16361936|NCT00160069|Drug|Sagopilone (BAY86-5302, ZK 219477)|22 mg/m2, 3-hour infusion, every 3 weeks
16361937|NCT00160056|Procedure|Hypoglycemia|
16361938|NCT00160043|Drug|SH T00268C|1250 mg experimental drug od
16361939|NCT00160043|Drug|PTK787/ ZK 222584|1250 mg experimental drug bid (500mg + 750mg)
16361940|NCT00160030|Drug|FOLFOX 4|total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.
16361941|NCT00160030|Drug|5-FU / Cisplatin|two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).
16361942|NCT00160017|Behavioral|Breakthrough collaborative|Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care
16361943|NCT00160004|Behavioral|Intensive Controlled Exercise|
16361944|NCT00159991|Procedure|Total arterial revascularization|Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts
16361945|NCT00159991|Procedure|Conventional revascularization|Coronary artery bypass grafting using LIMA and saphenous vein grafts
16361946|NCT00159978|Procedure|18F-FLT and 18F-MISO-PET|18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (≤ 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery.
16361947|NCT00159965|Drug|sertraline|flexible dose sertraline
16361948|NCT00159965|Drug|placebo|flexible dose placebo
16361949|NCT00159952|Procedure|intensive insulin therapy|"control: glycemia will be controlled with insulin administration when higher than 215 mg/dL.
~treatment: glycemia will be controlled with be controlled with insulin administration when higher than 110 mg/dL"
16361950|NCT00159939|Procedure|prone positioning|prone positioning
16361951|NCT00159926|Procedure|Cell saver|Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
16361952|NCT00159926|Procedure|No cell saver|Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass
16361953|NCT00159913|Drug|Sildenafil citrate|oral; 20mg, 40mg and 80 mg; 3 times a day(TID)
16361954|NCT00159913|Drug|Sildenafil citrate|oral; 10mg, 20mg and 40mg; 3 times a day(TID)
16361955|NCT00159913|Drug|Placebo|oral; 3 times a day(TID)
16361956|NCT00159913|Drug|Sildenafil citrate|oral; 10 mg; 3 times a day(TID)
16361957|NCT00159900|Drug|Sildenafil Citrate|
16361958|NCT00159887|Drug|Sildenafil citrate|
16361959|NCT00159874|Drug|Sildenafil citrate|Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid)
16361960|NCT00159874|Drug|Sildenafil citrate|Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg
16361961|NCT00159874|Drug|Sildenafil citrate|Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid)
16361962|NCT00159861|Drug|Sildenafil citrate|
16361963|NCT00159848|Behavioral|Treatment Optimization Program (educational material)|
16361964|NCT00159835|Drug|atorvastatin|
16361965|NCT00159835|Drug|simvastatin|
16361966|NCT00159822|Drug|Voriconazole|"Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.
~Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours"
16361967|NCT00159809|Drug|Viagra (Sildenafil citrate)|
16361968|NCT00159796|Drug|Asenapine|Asenapine, 3 weeks
16361969|NCT00159796|Drug|Olanzapine|Olanzapine, 3 weeks
16361970|NCT00159796|Drug|Placebo|placebo, 3 weeks
16361971|NCT00159783|Drug|asenapine|Asenapine, 40 weeks
16361972|NCT00159783|Drug|Olanzapine|Olanzapine, 40 weeks
16361973|NCT00159770|Drug|ziprasidone versus olanzapine , risperidone or quetiapine|
16361974|NCT00159770|Behavioral|Panss , CGI-C, UKU-SERS-Pa|
16361975|NCT00159770|Procedure|Blood tests|
16361976|NCT00159757|Drug|ziprazidone|
16361977|NCT00159744|Drug|Asenapine|Asenapine, 3 weeks
16361978|NCT00159744|Drug|Olanzapine|Olanzapine, 3 weeks
16361979|NCT00159744|Drug|Placebo|placebo, 3 weeks
16361980|NCT00159731|Drug|Pregabalin|
16361981|NCT00159718|Drug|amlodipine|
16361982|NCT00159718|Drug|atorvastatin|
16361983|NCT00159705|Drug|pregabalin|
16361984|NCT00159692|Drug|Amlodipine|
16361985|NCT00159679|Drug|Pregabalin|
16361986|NCT00159666|Drug|pregabalin|
16361987|NCT00159653|Drug|Xalacom|
16361988|NCT00159653|Drug|Xalatan|
16361989|NCT00159653|Drug|Timolol|
16361990|NCT00159640|Drug|PD-217,014|
16361991|NCT00159627|Drug|KW-3902IV|
16361992|NCT00159614|Drug|KW-3902IV|
16361993|NCT00159588|Drug|Betablockers or other preventive drugs|Several preventive drugs based on each individual
16362141|NCT00158431|Other|Medical Management|education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
16361994|NCT00159575|Drug|Metformin / Placebo treatment for 4 months|M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period
16361995|NCT00159562|Behavioral|individual education|individual sessions of psycho-education
16361996|NCT00159562|Behavioral|Group education|group psycho-education in 10 weekly sessions and then a session every third month for two years
16361997|NCT00159549|Behavioral|education and training program|
16361998|NCT00159536|Drug|Metformin|Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
16361999|NCT00159536|Drug|Placebo|Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
16362000|NCT00159523|Dietary Supplement|Probiotic|
16362001|NCT00159523|Biological|placebo|
16362002|NCT00159510|Drug|Methylene blue|Injection bolus of 2 mg/kg PBW and infusion of 0.2 mg/kg/hr
16362003|NCT00159510|Drug|Nitric oxide|An inhalation of NO via ETT at 10 ppm, partially weaned by 72 hrs of therapy
16362004|NCT00159510|Drug|Methylene blue & nitric oxide|See the dosage in the previous arms
16362005|NCT00159497|Device|porous coated Trilogy®|THA
16362006|NCT00159497|Device|Trilogy Calcicoat®|THA
16362007|NCT00159484|Drug|EPO906, celecoxib|EPO906 IV, every three weeks, celecoxib by mouth twice a day every day
16362008|NCT00159471|Drug|capecitabine, gemcitabine, docetaxel|
16362009|NCT00159458|Drug|Gemcitabine and oxaliplatin|
16362010|NCT00159445|Drug|gemcitabine, capecitabine|
16362011|NCT00159432|Drug|Oxaliplatin|
16362012|NCT00159432|Drug|Bevacizumab|
16362013|NCT00159432|Drug|Capecitabine|
16362014|NCT00159419|Drug|Alendronate|
16362015|NCT00159419|Drug|Pamidronate|
16362016|NCT00159406|Other|Registry and Database|Data Collection
16362017|NCT00159393|Other|registry and database|data collection
16362018|NCT00159380|Drug|Aminoguanidine|500mg
16362019|NCT00159380|Drug|Placebos|2ml
16362020|NCT00159367|Device|Repetitive magnetic stimulation to the quadriceps|
16362021|NCT00159354|Drug|predisolone|
16362022|NCT00159341|Procedure|Nasal lavage|Nasal lavage was carried out at specified timepoints
16362023|NCT00159341|Procedure|Nasal filter paper|Nasal filter paper was placed at specified timepoints
16362024|NCT00159341|Procedure|Blood sampling|Blood sampling was performed as a routine safety check
16362025|NCT00159328|Procedure|Magnetic Resonance Guided Focused Ultrasound|
16362026|NCT00159315|Procedure|Inhalation Challenge with ATP|
16362027|NCT00159315|Procedure|Inhalation Challenge with AMP|
16362028|NCT00159302|Procedure|Induced Sputum|
16362029|NCT00159302|Procedure|Exhaled Nitric Oxide|
16362030|NCT00159302|Procedure|Nasal Nitric Oxide|
16362031|NCT00159302|Procedure|Blood Tests|
16362032|NCT00159302|Procedure|24hr Urine Samples|
16362033|NCT00159302|Procedure|Exhaled Breath Condensate|
16362034|NCT00159302|Procedure|Spirometry|
16362035|NCT00159289|Procedure|Inhalation of LPS|
16362036|NCT00159289|Procedure|Placebo|
16362037|NCT00159276|Procedure|Induced Sputum|
16362038|NCT00159263|Drug|Placebos|Dry powder inhaler
16362039|NCT00159263|Drug|Formoterol Inhalant Powder|12ug
16362040|NCT00159263|Drug|Budesonide Powder|Inhaler
16362041|NCT00159263|Drug|Budesonide and Formoterol Product|Combination Inhaler, Symbicort
16362042|NCT00159250|Drug|AVI-4658 (PMO)|morpholino antisense oligonucleotide
16362043|NCT00159237|Procedure|blood test|
16362044|NCT00159224|Drug|Lopinavir/ritonavir simplification strategy|Simplification
16362045|NCT00159211|Drug|UMULINE NPH|UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
16362046|NCT00159211|Drug|pioglitazone|30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily
16362047|NCT00159172|Device|Motor cortex stimulation|
16362048|NCT00159159|Drug|Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l|
16362049|NCT00159159|Drug|Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l|
16362050|NCT00159146|Drug|Pindolol and venlafaxin|pindolol 20 mg and venlafaxin 150 mg
16362051|NCT00159133|Drug|antipsychotics vs. Lorazepam (Drugs)|Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
16362052|NCT00159120|Other|maintained antipsychotic treatment vs. stepwise drug discontinuation|maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
16362053|NCT00159107|Drug|Acamprosate|Acamprosate
16362054|NCT00159107|Behavioral|Integrative behavior therapy|Integrative behavior therapy
16362055|NCT00159107|Drug|Placebo|Placebo
16362056|NCT00159094|Drug|Doxil and Vinorelbine|
16362057|NCT00159081|Drug|Haloperidol, Risperidone (drug)|targeted dose of 2-4 mg/day over 1 year
16362058|NCT00159055|Biological|CMV vaccine|
16362059|NCT00159016|Drug|Glivec|
16362060|NCT00158990|Drug|triiodothyronine|
16362061|NCT00158990|Drug|sertraline|
16362062|NCT00158977|Device|CONTAK RENEWAL 3 AVT|CONTAK RENEWAL 3 AVT
16362063|NCT00158964|Device|EASYTRAK 4 STEERABLE LV lead|
16362064|NCT00158951|Device|CONTAK RENEWAL 2/4/4HE CRT-D|
16362065|NCT00158951|Device|EASYTRAK 2 Lead|
16362066|NCT00158938|Device|EASYTRAK 3 left ventricular pacing lead|
16362067|NCT00158925|Device|EASYTRAK EPI lead|EASYTRAK EPI lead
16362068|NCT00158912|Device|Implantable Cardioverter Defibrillator|
16362069|NCT00158899|Drug|GW501516 oral tablets|
16362070|NCT00158886|Drug|Topotecan|Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.
16362142|NCT00158418|Procedure|Cemented Humeral Stem|
16362143|NCT00158418|Procedure|Uncemented Humeral Stem|
16362071|NCT00158886|Radiation|Radiation therapy|For radiation therapy, subjects will receive 180 centigray (cGy) per fraction to a total dose of 4500 cGy to the pelvis using a 3 or 4 field technique and high energy photons (>=6 megavolt [mv]).
16362072|NCT00158873|Drug|midazolam|
16362073|NCT00158873|Drug|lorazepam|
16362074|NCT00158873|Drug|fentanyl|
16362075|NCT00158873|Drug|morphine|
16362076|NCT00158873|Drug|remifentanil|
16362077|NCT00158873|Drug|propofol|
16362078|NCT00158860|Drug|Valaciclovir|1g once daily
16362079|NCT00158860|Drug|Placebo|placebo
16362080|NCT00158847|Drug|fluticasone 500 mcg|
16362081|NCT00158847|Drug|fluticasone 500 mcg + salmeterol 50 mcg|
16362082|NCT00158834|Drug|Salmeterol/Fluticasone propionate combination product|
16362083|NCT00158834|Drug|Fluticasone propionate|
16362084|NCT00158821|Drug|Viread (tenofovir disoproxil fumarate)|Tenofovir DF 300 mg tablets once daily
16362085|NCT00158821|Drug|Sustiva (Efavirenz)|efavirenz capsules 600 mg once daily
16362086|NCT00158821|Drug|Epivir (Lamivudine)|lamivudine 150 mg tablets twice daily
16362087|NCT00158821|Drug|Zerit (Stavudine) Placebo|stavudine placebo capsules twice daily
16362088|NCT00158808|Biological|Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib|
16362089|NCT00158795|Biological|Haemophilus Influenza type b vaccine|
16362090|NCT00158782|Drug|GW786034|GW786034 (Pazopanib) is an orally active, potent, reversible, small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, VEGFR-3, platelet-derived growth factor receptor-alpha (PDGFR-alpha), PDGFR-beta, and c-Kit.
16362091|NCT00158782|Drug|lapatinib|Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2.
16362092|NCT00158769|Drug|Intravenous GR270773 - Phospholipid emulsion|GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.
16362093|NCT00158756|Biological|Tritanrix™-HepB|GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
16362094|NCT00158756|Biological|Rotarix™|GSK Biologicals' live attenuated human rotavirus vaccine
16362095|NCT00158756|Biological|Zilbrix™|GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
16362096|NCT00158756|Biological|Triple Antigen™|Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
16362097|NCT00158756|Biological|Engerix™-B|GSK Biologicals' hepatitis B vaccine
16362098|NCT00158756|Drug|Placebo|Placebo for the Rotarix™ vaccine
16362099|NCT00158743|Drug|Anti-digoxin antibody (FAB fragment)|intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
16362100|NCT00158743|Other|sodium chloride|
16362101|NCT00158730|Drug|AmBisome|
16362102|NCT00158717|Drug|Hepsera|
16362103|NCT00158704|Drug|Hepsera|
16362104|NCT00158691|Drug|Ethyol|
16362105|NCT00158678|Procedure|IMRT 75 Gy|50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
16362106|NCT00158678|Procedure|Conventional radiotherapy 70 Gy|50 Gy in PTV1 and 20 Gy in PTV2
16362107|NCT00158678|Drug|concomitant cisplatin|100 mg/m2 D1, D22, D43
16362108|NCT00158665|Biological|2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine|2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
16362109|NCT00158652|Procedure|Conventional radiotherapy 70 Gy in 7 weeks|2 gy per fraction, 1 fraction per day, 5 fractions per week
16362110|NCT00158652|Procedure|middle accelerated radiotherapy 70 Gy in 6 weeks|5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks
16362111|NCT00158652|Procedure|very accelerated radiotherapy 64.8 Gy in 3.5 weeks|2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
16362112|NCT00158652|Drug|5FU, Paraplatin|5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)
16362113|NCT00158639|Behavioral|Home BP;secure messaging;pharmaceutical care;|
16362114|NCT00158626|Behavioral|pelvic floor muscle training|
16362115|NCT00158613|Biological|Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap
16362116|NCT00158600|Biological|alglucosidase alfa|IV infusion of 20mg/kg; qow for 78 weeks.
16362117|NCT00158600|Drug|Placebo|Placebo Comparator; qow for 78 weeks.
16362118|NCT00158587|Drug|primaquine|
16362119|NCT00158574|Drug|sulphadoxine-pyrimethamine|
16362120|NCT00158574|Drug|mefloquine|
16362121|NCT00158574|Drug|Chlorproguanil-dapsone|
16362122|NCT00158574|Drug|Placebo|Placebo
16362123|NCT00158574|Drug|Sulphadoxine-pryrimethamine|IPTi doses 1 and 2, at ages 2 and 3 months, sulphadoxine 250mg, pyrimethamine 12.5mg IPTi doses 3, at 9 months of age, sulphadoxine 500mg, pyrimethamine 25mg
16362124|NCT00158574|Drug|IPTi mefloquine|IPTi doses 1 & 2 at ages 2 & 3 months, mefloquine 125mg IPTi dose 3 at 9 months, mefloquine 250mg
16362125|NCT00158574|Drug|Chlorproguanil dapsone|IPTi doses 1 and 2 at ages 2 and 3 months, doses 15mg chlorproguanil and 18.75mg dapsone IPTi dose 3 at 9 months of age, doses 22.5mg chlorproguanil and 28.13mg dapsone
16362126|NCT00158561|Drug|sulfadoxine-pyrimethamine and chlorproguanil-dapsone|
16362127|NCT00158548|Drug|SP, chloroquine, amodiaquine, primaquine, artesunate|
16362128|NCT00158535|Procedure|liver transplantation|
16362129|NCT00158522|Drug|pegylated interferon alpha2a|
16362130|NCT00158509|Drug|Valacyclovir|
16362131|NCT00158496|Drug|pegylated interferon alpha2a|
16362132|NCT00158496|Drug|ribavirin|
16362133|NCT00158483|Drug|Acyclovir (ACV)|
16362134|NCT00158470|Drug|efavirenz|
16362135|NCT00158470|Drug|didanosine|
16362136|NCT00158470|Drug|lamivudine|
16362137|NCT00158457|Drug|Tenofovir (TDF)|
16362138|NCT00158457|Drug|Emtricitabine (FTC)|
16362139|NCT00158457|Drug|Efavirenz (EFV)|
16362140|NCT00158431|Procedure|Arthroscopy plus Medical Management|Arthroscopic Surgery
16362144|NCT00158405|Procedure|Structured Treatment Interruption|
16362145|NCT00158405|Drug|Zidovudine (ZDV)|
16362150|NCT00158379|Drug|Paclitaxel|4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
16362151|NCT00158366|Behavioral|Behavioral training|The behavioral training will teach participants ways to control their diet and increase their physical activity.
16362152|NCT00158366|Behavioral|Social skills training|The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
16362153|NCT00158366|Behavioral|Behavioral training booster sessions|During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.
16362154|NCT00158353|Behavioral|GirlPOWER! mentoring program|GirlPOWER! mentoring program includes monthly 3-hour workshops for youth and mentors combined with monthly supplemental activities to be completed independently by youth-mentor pairs.
16362155|NCT00158353|Behavioral|Traditional mentoring|Traditional mentoring includes a community-based mentoring program, in which the youth-mentor spends time together in activities of their choosing 2 to 4 times a month.
16362156|NCT00158340|Behavioral|Guided self-help cognitive behavioral therapy (CBT)|Participants receive eight sessions of guided self-help CBT.
16362157|NCT00158340|Behavioral|Usual clinical care|Control group participants receive treatment as usual.
16362158|NCT00158327|Behavioral|Telephone-based collaborative care|Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive. The choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants will receive telephone calls one to two times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used.
16362159|NCT00158327|Behavioral|Usual care|Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians and will be delivered for 12 months.
16362160|NCT00158314|Behavioral|Referral to Gamblers Anonymous|
16362161|NCT00158314|Behavioral|Cognitive behavioral therapy|
16362162|NCT00158314|Behavioral|Cognitive behavioral self-help manual|
16362163|NCT00158301|Behavioral|Cognitive behavioral therapy (CBT)|CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.
16362164|NCT00158301|Drug|Drug therapy|All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
16362165|NCT00158288|Behavioral|LAAM|
16362166|NCT00158275|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
16362167|NCT00158275|Drug|Antidepressants|Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
16362168|NCT00158275|Behavioral|Problem solving therapy|Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.
16362169|NCT00158262|Drug|Propranolol|Propranolol short-acting or long-acting capsule
16362170|NCT00158262|Drug|Placebo|Placebo-matching propranolol short-acting or long-acting capsule
16362171|NCT00158249|Drug|citicoline|2 gm/day, 8 weeks treatment
16362172|NCT00158249|Drug|placebo|matched for physical appearance
16362173|NCT00158236|Drug|Buprenorphine|
16362174|NCT00158236|Drug|Buprenorphine and Naloxone|
16362175|NCT00158236|Drug|Hydromorphone|
16362176|NCT00158223|Drug|Pimozide|Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects.
16362177|NCT00158223|Drug|Placebo|Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There will be flexible dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.
16362178|NCT00158210|Drug|Rivastigmine|
16362179|NCT00158197|Behavioral|contingency management voucher|participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
16362180|NCT00158184|Drug|oxycodone 15 mg|15 mg/70 kg oxycodone administered once per day, orally.
16362181|NCT00158184|Drug|oxycodone 30 mg|30 mg/70 kg oxycodone administered once per day, orally.
16362182|NCT00158184|Drug|Placebo 0 mg|0 mg placebo dose administered once a day, orally.
16362183|NCT00158171|Drug|Nicotine Replacement Therapies|Nicotine gum 2 & 4 mg dependent on baseline smoking rate
16362184|NCT00158171|Drug|Nicotine patch|21, 14 or 7 mg patch dependent on baseline smoking rate
16362185|NCT00158171|Dietary Supplement|Folic Acid|400 mg
16362186|NCT00158158|Drug|Usual Care|If unable to quit at quit date, offered usual care to set another quit date.
16362187|NCT00158158|Other|Smoking Reduction|If unable to quit smoking, reduce smoking rate prior to quit date.
16362188|NCT00158132|Drug|Propranolol|Propranolol 100mg/day in 3 divided doses
16362189|NCT00158132|Drug|Amantadine|Amantadine 100mg three times daily
16362190|NCT00158132|Drug|Placebo|Placebo pills
16362191|NCT00158119|Behavioral|InVEST (Increased Velocity Exercise Specific to Task)|
16362192|NCT00158106|Procedure|Speech and Language therapy for dysarthria and/or aphasia|
16362193|NCT00158093|Drug|Nebivolol|
16362194|NCT00158093|Drug|Atenolol|
16362195|NCT00158093|Drug|Moxifloxacin|
16362196|NCT00158080|Procedure|hemofiltration|
16362197|NCT00158067|Device|external Responsive Neurostimulator (eRNS) System|
16362382|NCT00156117|Drug|olanzapine|olanzapine 15 mg QD
16362198|NCT00158054|Behavioral|Enhanced depression care|Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.
16362199|NCT00158054|Behavioral|Referred depression care|Physician notified of depression symptoms, usual care followed.
16362200|NCT00158041|Drug|Amifostine administered subcutaneously|
16362201|NCT00158028|Drug|Risperidone|The dosage of risperidone was titrated upward in a stepwise design, beginning with 0.25 mg/d for the first week, 0.5 mg/d for weeks 2 and 3, 1.0 mg/d for weeks 4 and 5, 1.5 mg/d for weeks 6 and 7, and 2.0 mg/d for the remaining weeks.
16362202|NCT00158028|Drug|Placebo|placebo match in identical tablets
16362203|NCT00158002|Drug|Topiramate|
16362204|NCT00157989|Procedure|Controlled tidal volume resuscitation|
16362205|NCT00157976|Drug|Photrex (rostaporfin)|
16362206|NCT00157963|Drug|MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks|
16362207|NCT00157950|Biological|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
16362208|NCT00157950|Biological|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
16362209|NCT00157937|Drug|MK0476; montelukast sodium/Duration of Treatment: 16 weeks|
16362210|NCT00157937|Drug|Comparator: theophylline ER/Duration of Treatment: 16 weeks|
16362211|NCT00157924|Drug|simvastatin (+) ezetimibe|simvastatin (+) ezetimibe 10/20mg.
16362212|NCT00157924|Drug|atorvastatin|atorvastatin 10mg
16362213|NCT00157911|Drug|MK0653; ezetimibe / Duration of Treatment: 12 weeks|
16362214|NCT00157911|Drug|Comparator: simvastatin / Duration of Treatment: 12 weeks|
16362215|NCT00157898|Drug|MK0826; ertapenem sodium|
16362216|NCT00157898|Drug|Comparator: ceftriaxone + metronidazole|
16362217|NCT00157885|Drug|Amodiaquine plus artesunate; Artekin|
16362218|NCT00157872|Drug|MK0966; rofecoxib|
16362219|NCT00157872|Drug|Comparator: naproxen tablet 500 mg|
16362220|NCT00157859|Drug|Chloroquine and sulphadoxine-pyrimethamine|
16362221|NCT00157846|Device|CRT-P or CRT-D Device|Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)
16362222|NCT00157833|Drug|Artekin / Coartemther|
16362223|NCT00157820|Device|Single Chamber Implantable Cardioverter Defibrillator|Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD
16362224|NCT00157820|Device|Dual Chamber implantable cardioverter defibrilator|Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)
16362225|NCT00157807|Procedure|bipolar radiofrequency ablation of persistent and permanent AF|
16362226|NCT00157794|Device|Search AV+ algorithm|
16362227|NCT00157781|Device|Medtronic AT500|
16362228|NCT00157768|Device|Implantable cardioverter defibrillator|
16362229|NCT00157755|Device|Enterra Therapy|Gastric electrical stimulation using Enterra Therapy.
16362230|NCT00157742|Procedure|Spinal Cord Stimulation (SCS)|
16362231|NCT00157742|Procedure|Percutaneous Myocardial Laser Revascularisation (PMR)|
16362232|NCT00157729|Drug|pyridoxal-5'-phosphate with and without ACE inhibitor|
16362233|NCT00157716|Drug|(MC-1) Pyridoxal-5'-phosphate|
16362234|NCT00157703|Drug|G207|1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)
16362235|NCT00157690|Drug|Alendronate|70 mg 1x weekly for 12 months
16362236|NCT00157690|Drug|Placebo|70 mg 1 x weekly for 12 months
16362237|NCT00157677|Procedure|D-dimer testing|Uniform D-dimer use
16362238|NCT00157677|Procedure|D-dimer testing|Selective D-Dimer use
16362239|NCT00157651|Drug|warfarin|Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
16362240|NCT00157651|Drug|placebo|matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
16362241|NCT00157638|Behavioral|integration of pharmacist into primary care|
16362242|NCT00157638|Drug|optimizing therapeutic treatments|
16362243|NCT00157638|Behavioral|optimizing processes of care|
16362244|NCT00157625|Behavioral|Automatic stop order|
16362245|NCT00157612|Procedure|a clinical pathway nursing home acquired pneumonia|treatment in nursing homes according to a clinical pathway, which included use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, rehydrations and close monitoring by research nurse
16362246|NCT00157599|Procedure|various diagnostic measures for DVT (e.g., CUS)|
16362247|NCT00157586|Drug|Delapril, Delapril-Manidipine Fixed combination|
16362248|NCT00157573|Drug|GM-CSF, sargramostim|GM-CSF subcutaneous injection
16362249|NCT00157560|Drug|Chemotherapy, multiple agents|
16362250|NCT00157547|Drug|Selective serotonin reuptake inhibitors (SSRI)|Selective serotonin reuptake inhibitors (SSRI)
16362251|NCT00157534|Drug|Celgosivir|
16362252|NCT00157521|Drug|L-arginine|
16362253|NCT00157508|Drug|nitroaspirin|
16362254|NCT00157482|Drug|Ezetimibe|
16362255|NCT00157482|Drug|Simvastatin|
16362256|NCT00157378|Drug|Risperidone, Haloperidol|
16362257|NCT00157339|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 12 months
16362258|NCT00157339|Drug|injected insulin|patient specific dose, injected, before meals, 12 months.
16362259|NCT00157326|Drug|tadalafil|
16362260|NCT00157313|Behavioral|Integrated treatment, family involvement|
16362261|NCT00157313|Behavioral|Social skills training|
16362262|NCT00157300|Drug|Epoetin beta|intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
16362263|NCT00157287|Procedure|Evidence based weaning protocol|
16362264|NCT00157274|Drug|alemtuzumab|
16362265|NCT00157261|Drug|tenecteplase|
16362266|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
16362267|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
16362268|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
16362269|NCT00157248|Drug|dabigatran etexilate|dosage used at study start
16362270|NCT00157235|Drug|Tiotropium bromide|
16362378|NCT00156130|Radiation|Conventional radiotherapy schedule|50 Gy in 25 fractions over 35 days
16362383|NCT00156104|Drug|Asenapine|5 mg BID
16362271|NCT00157209|Biological|Tecemotide (L-BLP25)|After receiving single low dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from the study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of the investigator, and in case of unavailability of study vaccine.
16362272|NCT00157209|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.
16362273|NCT00157209|Other|Best Supportive Care (BSC)|The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.
16362274|NCT00157196|Biological|Tecemotide (L-BLP25)|After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide [L-BLP25]) at 6-week intervals, commencing at Week 13, until disease progression is documented.
16362275|NCT00157196|Drug|Single low dose cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
16362276|NCT00157196|Other|Best standard of care (BSC)|The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.
16362277|NCT00157183|Device|Nocturnal oxygen , nocturnal bi-level positive pressure ventilation|
16362278|NCT00157170|Behavioral|supervised exercise|
16362279|NCT00157157|Biological|Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)|"Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator).
~The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care.
~For incremental recovery assessments, a single infusion at 50 +/- 5 IU/kg was to be given.
~Immune tolerance induction (ITI) therapy for subjects who developed factor VIII inhibitors was at the discretion of the investigator, based on the institution's guidelines or described in peer-reviewed literature, and was to be approved by the sponsor's medical director.
~rAHF-PFM was to be administered intravenously via bolus infusion, except for perioperative management when it may have been given either by continuous or bolus infusion."
16362280|NCT00157131|Biological|Fibrin Sealant, ARTISS 4IU/ml VH SD|FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set.
16362281|NCT00157131|Other|Staples|Administration by mechanical/multiple point fixation.
16362282|NCT00157118|Drug|Protein C Concentrate (Human) Vapor Heated|
16362283|NCT00157105|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
16362284|NCT00157092|Drug|Aerosolized, Recombinant Alpha 1-Antitrypsin|
16362285|NCT00157079|Biological|Immune Globulin Intravenous (Human), 10%|
16362286|NCT00157066|Drug|Ergocalciferol|
16362287|NCT00157053|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
16362288|NCT00157040|Drug|Antihemophilic factor, recombinant, manufactured protein-free|
16362289|NCT00157027|Procedure|Extracorporeal photochemotherapy with UVADEX|"Photopheresis (or extracorporeal photoimmunetherapy [ECP]) is a process developed by THERAKOS, Inc., a Johnson and Johnson Company. During the process of ECP, whole blood is drawn from the patient over several cycles, centrifuged and separated into the components of plasma, white cells (or buffy coat), and red blood cells. A portion of the white cells and the plasma are saved in a separate compartment. The remaining plasma and red blood cells are immediately returned to the patient.
~The saved buffy coat (white blood cells) and plasma are inoculated with the photosensitizing agent UVADEX. Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light. After photoactivation is complete, the treated suspension is returned to the patient."
16362290|NCT00157014|Drug|Tacrolimus|Oral
16362291|NCT00157014|Drug|Cyclosporine|Oral
16362292|NCT00157014|Drug|Mycophenolate mofetil|Intravenous and Oral
16362293|NCT00157014|Drug|Methylprednisolone|Intravenous
16362294|NCT00157014|Drug|Prednisone|Oral
16362295|NCT00157001|Procedure|Photopheresis Post Angioplasty|
16362296|NCT00156988|Drug|cerium nitrate-silver sulfadiazine (cerium-flamazine)|
16362297|NCT00156975|Drug|Capecitabine|
16362298|NCT00156975|Drug|Oxaliplatin|
16362299|NCT00156962|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
16362300|NCT00156962|Drug|Epoetin alfa RB|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
16362301|NCT00156949|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
16362302|NCT00156936|Drug|Medisorb naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
16362303|NCT00156936|Drug|Oral naltrexone to Medisorb naltrexone 380 mg|Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
16362304|NCT00156923|Drug|Medisorb naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
16362305|NCT00156923|Drug|Medisorb naltrexone 190 mg|Administered via IM injection once every 4 weeks for up to 3.5 years.
16362379|NCT00156130|Radiation|Accelarated radiotherapy schedule|42.5 Gy in 16 fractions over 22 days
16362380|NCT00156117|Drug|asenapine|5 mg BID or 10mg BID
16362381|NCT00156117|Drug|Placebo|Placebo
16362306|NCT00156910|Biological|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
16362307|NCT00156910|Other|Placebo (saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
16362308|NCT00156897|Drug|ATL-962|
16362309|NCT00156897|Drug|Orlistat|
16362310|NCT00156884|Drug|strontium-89|
16362311|NCT00156884|Drug|cisplatin|
16362312|NCT00156871|Behavioral|exercise|
16362313|NCT00156858|Drug|intravenous busulfan|
16362314|NCT00156845|Procedure|AI-700 contrast-enhanced echocardiography|
16362315|NCT00156819|Drug|fluticasone|fluticasone (100 microgram twice daily) treatment
16362316|NCT00156819|Drug|montelukast|Montelukast (5 or 10 mg each night).
16362317|NCT00156819|Drug|Fluticasone plus salmeterol|fluticasone (100 microgram) plus salmeterol (50 microgram) each night
16362318|NCT00156806|Procedure|Aloe barbadensis topical application in a moisturizing cream vehicle.|
16362319|NCT00156793|Procedure|AI-700 contrast-enhanced echocardiography|
16362320|NCT00156780|Drug|AI-700|
16362321|NCT00156741|Device|Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2|
16362322|NCT00156741|Procedure|Required pacemaker setting|
16362323|NCT00156728|Device|Vitatron biventricular pacemaker|
16362324|NCT00156715|Drug|Quetiapine|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
16362325|NCT00156702|Behavioral|Feedback and Motivational Interviewing|
16362326|NCT00156702|Behavioral|Smoking Prevention Video|
16362327|NCT00156689|Drug|levetiracetam|
16362328|NCT00156676|Device|Body-weight supported treadmill|
16362329|NCT00156676|Device|Lokomat|
16362330|NCT00156676|Device|Body-weight supported treadmill|
16362331|NCT00156676|Device|Lokomat|
16362332|NCT00156663|Behavioral|Caring for Women Veterans|
16362333|NCT00156650|Drug|Acyline|Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks
16362334|NCT00156650|Drug|Testosterone Gel|Testosterone (T) gel 10 g daily for 6 months
16362335|NCT00156650|Drug|Depo-Medroxyprogesterone|300 mg IM every 3 months
16362336|NCT00156637|Behavioral|Team-Based Quality Improvement Intervention|Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort
16362337|NCT00156637|Behavioral|Opinion Leader Intervention|Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort
16362338|NCT00156637|Behavioral|Team Based Quality Improvement|Intervention to increase appropriate use of clozapine through a team based quality intervention.
16362339|NCT00156624|Drug|Balloon Angioplasty with or without drug administration|
16362340|NCT00156611|Procedure|Balloon Angioplasty|
16362341|NCT00156611|Drug|ReoPro|
16362342|NCT00156572|Procedure|Sodium supplementation|
16362343|NCT00156572|Procedure|Fluid restriction|
16362344|NCT00156546|Drug|antibiotic to reduce the recurrence of infection|
16362345|NCT00156533|Drug|Zolpidem|10 mg of Zolpidem
16362346|NCT00156533|Drug|Sugar Pill|
16362347|NCT00156520|Drug|aprotonin; epsilon aminocaproic acid|
16362348|NCT00156507|Behavioral|Asthma education for parents of very low birth weight infants|Asthma education is provided to parents of children in the experimental group prior to nicu discharge.
16362349|NCT00156468|Behavioral|Provider Prompt|
16362350|NCT00156416|Behavioral|Mindfulness Meditation|8 weeks of meditation training
16362351|NCT00156403|Drug|amlodipine (drug)|
16362352|NCT00156390|Device|echo-guided left ventricular lead placement|placement of the LV lead of the biventricular pacing device under echocardiographic guidance
16362353|NCT00156390|Other|LV lead placement as per standard of care (without echo guidance)|
16362354|NCT00156377|Drug|Mupirocin|
16362355|NCT00156351|Behavioral|Physical activity promotion|
16362356|NCT00156338|Procedure|fluid management|volume and sodium restriction
16362357|NCT00156338|Procedure|fluid management|volume restriction
16362358|NCT00156338|Procedure|fluid management|liberal fluid management
16362359|NCT00156325|Drug|Escitalopram (Lexapro)|
16362360|NCT00156312|Drug|Docetaxel|
16362361|NCT00156312|Drug|Capecitabine|
16362362|NCT00156299|Drug|choline magnesium trisalicylate|1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
16362363|NCT00156299|Drug|Dexamethasone|10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
16362364|NCT00156286|Drug|Gleevec|
16362365|NCT00156260|Procedure|Ductal lavage|
16362366|NCT00156247|Drug|acitretin|Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
16362367|NCT00156234|Behavioral|One-knee extension ergometer|
16362368|NCT00156208|Drug|Asoprisnil|10mg Tablet, oral Daily for 18 months
16362369|NCT00156208|Drug|Asoprisnil|25 mg Tablet, oral Daily for 18 months
16362370|NCT00156195|Drug|Asoprisnil|10 mg Tablet, oral Daily for 12 months
16362371|NCT00156195|Drug|Asoprisnil|25 mg Tablet, oral Daily for 12 months
16362372|NCT00156182|Drug|Asoprisnil|10mg Tablet, oral Daily for 6 months
16362373|NCT00156169|Drug|Dunaliella|
16362374|NCT00156156|Drug|Asoprisnil|Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
16362375|NCT00156156|Drug|Asoprisnil|Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
16362376|NCT00156143|Procedure|Blood sample|
16362384|NCT00156104|Drug|Asenapine|10 mg BID
16362385|NCT00156104|Drug|Haloperidol|4 mg BID
16362386|NCT00156104|Other|Placebo arm|
16362387|NCT00156091|Drug|Olanzapine|5- 20 mg QD
16362388|NCT00156091|Drug|Asenapine|5 or 10 mg BID
16362389|NCT00156091|Other|Placebo|
16362390|NCT00156078|Drug|pregabalin|
16362391|NCT00156065|Drug|Haloperidol|2-8 mg BID
16362392|NCT00156065|Drug|Asenapine|5 or 10 mg BID
16362393|NCT00156065|Drug|Asenapine|5 or 10 mg BID
16362394|NCT00156052|Radiation|Conventional whole breast radiation schedule|
16362395|NCT00156052|Radiation|Hypofractionated whole breast radiation schedule|
16362396|NCT00156039|Behavioral|Follow-up Strategy for Breast Cancer|
16362397|NCT00156026|Procedure|loop electrosurgical excision procedure (LEEP)|1. loop electrosurgical excision procedure
16362398|NCT00156013|Drug|CLOFARABINE|4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles
16362399|NCT00156000|Device|Fetal Fibronectin|fFN test done during pregnancy
16362400|NCT00156000|Device|Salivary Estriol|Salivary Estriol done during pregnancy
16362401|NCT00155987|Procedure|Early decompressive craniectomy|Large bifrontotemporal decompressive craniectomy
16362402|NCT00155974|Biological|Community-based vaccine outreach intervention|
16362403|NCT00155935|Procedure|venous puncture|
16362404|NCT00155883|Drug|Taxteral|
16362405|NCT00155883|Drug|5-Fluorouracil|
16362406|NCT00155883|Drug|Leucovorin|
16362407|NCT00155870|Behavioral|questionnaires|
16362408|NCT00155766|Biological|HPV16 E7 peptide-pulsed autologous DCs|
16362409|NCT00155714|Drug|type-5 phosphodiesterase Inhibitor (Sildenafil)|
16362410|NCT00155675|Drug|GUSUIBU|
16362411|NCT00155662|Behavioral|work-hardening program|
16362412|NCT00155610|Device|intravesical current perception test|
16362413|NCT00155597|Behavioral|home physical therapy|
16362414|NCT00155558|Drug|5-Fluorouracil, Leucovorin|
16362415|NCT00155545|Behavioral|Motion analysis of patients|
16362416|NCT00155532|Procedure|3 mm-punch biopsies of the skin|
16362417|NCT00155493|Procedure|obtain surgical specimen for analysis|
16362418|NCT00155480|Procedure|computed tomography|
16362419|NCT00155467|Procedure|CT|
16362420|NCT00155454|Procedure|Intravitreal long acting gas (10% C3F8)|At the end of surgery, fluid-gas exchange with 10% C3F8 were done in the eye of study group
16362421|NCT00155441|Behavioral|cognitive-behavioral therapy|
16362422|NCT00155428|Procedure|rapid prototyping|
16362423|NCT00155428|Procedure|computed tomography|
16362424|NCT00155415|Behavioral|Different timing of taking polyethylene glycol(PEG)|
16362425|NCT00155402|Drug|tissue fibrin glue application (Tisseel)|Apply several droplets within several seconds to several minutes
16362426|NCT00155389|Drug|Helicobacter pylori eradication|"For subjects who received the first-line treatment, the costs included the initial 13C-UBT, one-week triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and clarithromycin 500mg twice daily), and the confirmatory 13C-UBT. For subjects in whom the initial treatment failed, the costs further included the re-treatment consisting of ten-day triple therapy (esomeprazole 40mg once daily, amoxicillin 1g twice daily, and levofloxacin 500mg once daily), and the confirmatory 13C-UBT.
~The first round of study was between 2004 and 2005, the second round was between 2008 and 2009, and the third round was between 2012 and 2013."
16362427|NCT00155376|Drug|morphine and glucagon|
16362428|NCT00155363|Device|conventional artificial kidney (AK) vs. high flux AK|
16362429|NCT00155350|Drug|pioglitazone|
16362430|NCT00155337|Procedure|photodynamic therapy|
16362431|NCT00155324|Device|Extracorporeal Shock Wave Therapy (Device)|
16362432|NCT00155311|Procedure|orthodontic treatment|
16362433|NCT00155285|Procedure|computed tomography|
16362434|NCT00155272|Drug|Thalidomide|
16362435|NCT00155259|Drug|Docetaxel , Cisplatin , Capecitabine|
16362436|NCT00155246|Drug|pentoxifylline (drug)|
16362437|NCT00155233|Drug|Nalbuphine and morphine|
16362438|NCT00155220|Device|Low Stretch Bandage and Kinesio Tape|
16362439|NCT00155064|Drug|captopril, Losartan (drug)|
16362440|NCT00154986|Procedure|immunohistochemical staining, transfection, invasion assay|
16362441|NCT00154895|Drug|intrapleural minocycline instillation|
16362442|NCT00154882|Drug|Paclitaxel (Phyxol) , Cisplatin|
16362443|NCT00154869|Drug|Peginterferon Alfa-2a plus Ribavirin|
16362444|NCT00154856|Behavioral|Detect the variation of limb lengthening|
16362445|NCT00154843|Drug|Lycopene|A: Lycopene15 mg/day ; B: Lycopene30 mg/day
16362446|NCT00154830|Behavioral|cerebral palsy|
16362447|NCT00154830|Behavioral|crouch gait|
16362448|NCT00154817|Procedure|radiotherapy|
16362449|NCT00154804|Drug|Paclitaxel, Cisplatin,Surgery, CCRT|
16362450|NCT00154791|Drug|oxaliplatin|
16362451|NCT00154791|Drug|gemcitabine|
16362452|NCT00154791|Drug|5-FU/LV|
16362453|NCT00154778|Drug|Taxol, UFT,Leucovorin|
16362454|NCT00154765|Device|sling suspension exercises|
16362455|NCT00154752|Procedure|CCRT, Pelvic lymphadenoectomy.|
16362456|NCT00154739|Drug|Gemcitabine|
16362457|NCT00154739|Drug|Cisplatin|
16362458|NCT00154739|Drug|Epirubicin|
16362459|NCT00154726|Drug|Paclitaxel-HDFL|
16362460|NCT00154713|Biological|CEA pulsed dendritic cells|
16362461|NCT00154700|Drug|Paclitaxel,Cisplatin,5-Fu,Folic Acid|
16362462|NCT00154687|Drug|Paclitaxel, Cisplatin, 5-Fluorouracil|
16362463|NCT00154674|Device|ICY catheter, Thermoguard device|
16362464|NCT00154661|Drug|pentoxifylline|
16362465|NCT00154648|Procedure|CE-MRA|
16362466|NCT00154635|Drug|DCB-AD1|
16362467|NCT00154622|Behavioral|work hardening program|
16362468|NCT00154609|Drug|Gu-Sui-Bu (Davallia Divaricata)|
16362469|NCT00154570|Device|EGG, 24 hour esophageal pH monitor|
16362470|NCT00154557|Behavioral|elite judo athletes program|
16362471|NCT00154518|Procedure|Orthodontic treatment|
16362472|NCT00154505|Device|Lateral trunk support of wheelchair seating|
16362473|NCT00154492|Drug|activated recombinant human factor VII|
16362474|NCT00154466|Behavioral|cardiac rehabilitation|Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2); those in the nontraining group continued their usual lifestyle.
16362475|NCT00154453|Procedure|obtain surgical specimen for analysis|
16362476|NCT00154440|Drug|proton pump inhibitor|
16362477|NCT00154440|Drug|clarithromycin|
16362478|NCT00154440|Drug|amoxicillin|
16362479|NCT00154440|Drug|metronidazole|
16362480|NCT00154440|Procedure|radiation therapy|
16362481|NCT00154427|Drug|activated recombinant human factor VII|
16362482|NCT00154414|Drug|liraglutide|
16362483|NCT00154401|Drug|liraglutide|
16362484|NCT00154388|Drug|Imatinib mesylate|
16362485|NCT00154375|Drug|Imatinib mesylate|Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles.
16362486|NCT00154375|Drug|Hydroxyurea|
16362487|NCT00154362|Drug|Oxcarbazepine|
16362488|NCT00154349|Drug|Imatinib Mesylate|
16362489|NCT00154336|Drug|Imatinib|
16362490|NCT00154336|Drug|Methotrexate|
16362491|NCT00154336|Drug|Imatinib Placebo|
16362492|NCT00154323|Drug|Oxcarbazepine|
16362493|NCT00154310|Drug|Everolimus|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.
16362494|NCT00154310|Drug|Cyclosporine|Tablets orally twice a day to maintain protocol specific target blood levels
16362495|NCT00154310|Drug|Enteric-coated mycophenolate sodium|Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.
16362496|NCT00154310|Drug|Corticosteroids|Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
16362497|NCT00154297|Drug|Everolimus (RAD001)|
16362498|NCT00154284|Drug|Everolimus (Certican)|
16362499|NCT00154284|Drug|Cyclosporine (Neoral)|
16362500|NCT00154284|Drug|Steroid|Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
16362501|NCT00154284|Drug|Basiliximab (Simulect)|
16362502|NCT00154271|Drug|Valsartan, Valsartan HCT|
16362503|NCT00154258|Drug|Clozapine|
16362504|NCT00154245|Drug|Enteric-Coated Mycophenolate sodium (EC-MPS)|
16362505|NCT00154232|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16362506|NCT00154219|Drug|Lumiracoxib (drug)|
16362507|NCT00154206|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|
16362508|NCT00154193|Drug|cyclosporine|patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.
16362509|NCT00154180|Drug|Conjugated equine estrogens 0.45 mg/day|Pill, 1 pill taken daily each month for the study duration
16362510|NCT00154180|Drug|Transdermal estradiol, 50 mcg/day|Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.
16362511|NCT00154180|Drug|Micronized progesterone, 200 mg/day x 12 d/month|capsule, 1 capsule taken daily for the first 12 days of each month for the study duration
16362512|NCT00154180|Drug|CEE , progesterone, estradiol patch or placebo for each|CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week
16362513|NCT00154180|Drug|CEE, progesterone, transdermal patch or the placebo|CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent
16362514|NCT00154167|Drug|NV-101 (phentolamine mesylate solution)|
16362515|NCT00154154|Behavioral|General Psychiatric Management|General Psychiatric Management (GPM) condition consisting of a structured algorithmic medication intervention plus psychosocial counseling.
16362516|NCT00154154|Behavioral|Dialectical Behaviour Therapy|Modification of behaviours achieved with reframing thoughts and impulses
16362517|NCT00154141|Drug|Fibrin sealant (FS2)|
16362518|NCT00154128|Device|occlusal appliance|
16362519|NCT00154115|Drug|levosimendan|Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
16362520|NCT00154115|Drug|placebo|Placebo
16362521|NCT00154102|Drug|Cetuximab|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Number of Cycles: until progression or unacceptable toxicity develops
16362522|NCT00154102|Drug|FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
16362523|NCT00154089|Drug|EM-1421|EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) EM-1421
16362524|NCT00154076|Drug|Zonisamide|Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
16362525|NCT00154076|Drug|Topiramate|Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
16362526|NCT00154063|Drug|E2007|
16362527|NCT00154063|Other|Placebo|
16362528|NCT00154050|Drug|candesartan (drug) or quinapril (drug)|
16362529|NCT00154037|Drug|Pioglitazone (drug) and/or candesartan (drug)|
16362530|NCT00154024|Drug|atorvastatin|
16362531|NCT00154024|Drug|irbesartan|
16362532|NCT00154011|Drug|rosiglitazone (drug)|
16362533|NCT00153998|Drug|Cetuximab|
16362534|NCT00153998|Procedure|Liver resection|
16362535|NCT00153998|Drug|Cetuximab and FOLFIRI|"Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
~Cetuximab 250 mg/m² (1.0 h i.v.) weekly
~Irinotecan 180 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)"
16362587|NCT00153608|Biological|WT1 126-134 peptide|
16362588|NCT00153595|Drug|EWO1|
16362589|NCT00153582|Biological|WT1 126-134 peptide|
16362590|NCT00153569|Biological|Tyrosinase, MAGE-3, GnTV|
16362536|NCT00153998|Drug|Cetuximab and FOLFOX|"Cetuximab 400 mg/m² (2.0 h i.v.) (first dose only), followed by:
~Cetuximab 250 mg/m² (1.0 h i.v.) weekly
~Oxaliplatin 100 mg/m² (2.0 h i.v.) all compounds day 1, repeated at day 15 Folinic acid (D,L) 400 mg/m² (2.0 h i.v.) 5-FU 400 mg/m² (bolus i.v.) 5-FU 2400 (-3000) mg/m² (46 h i.v.)"
16362537|NCT00153985|Drug|Busulfex|Given once daily for 4 days
16362538|NCT00153985|Drug|Fludarabine|Given intravenously once daily for 4 days
16362539|NCT00153985|Drug|Alemtuzumab|One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days.
16362540|NCT00153985|Procedure|Stem Cell Transfusion|Performed three days after the end of chemotherapy
16362541|NCT00153972|Drug|Cabergoline|
16362542|NCT00153972|Drug|Levodopa|
16362543|NCT00153959|Behavioral|acute psychiatric day care|
16362544|NCT00153946|Drug|Edaravone|30mg/20mL vial, twice per day, not longer than two weeks
16362545|NCT00153933|Drug|Bortezomib|Given intravenously on days 1, 2, 8, 11 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
16362546|NCT00153933|Drug|CC-5013|Orally on days 1-14 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
16362547|NCT00153920|Drug|bortezomib|
16362548|NCT00153907|Drug|Navelbine|Given orally on day 1 and 8 of each cycle, dose will vary. If participant is at highest dose they will take navelbine on day 1, 8 and 15 until disease progression or unacceptable side effects occur.
16362549|NCT00153907|Drug|Capecitabine|Taken twice a day on days 1-14 until disease progression or unacceptable side effects occur.
16362550|NCT00153894|Behavioral|Strength training|One-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks.
16362551|NCT00153894|Behavioral|Endurance training|Cardiovascular training at home for 30 minutes three times per week for 16 weeks.
16362552|NCT00153881|Drug|Capecitabine (Xeloda)|"Neoadjuvant Chemotherapy:
~Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed.
~Concomitant chemotherapy and radiation:
~Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles)."
16362553|NCT00153868|Biological|darbepoetin alfa|The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience <1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations >13.0 g/dL.
16362554|NCT00153842|Drug|Bexarotene (targretin)|"Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
~Level 1: 300 mg"
16362555|NCT00153842|Drug|Bexarotene (targretin)|"Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1).
~Level 2: 400 mg"
16362556|NCT00153829|Behavioral|Multifaceted outreach facilitation for chronic illness care|
16362557|NCT00153816|Drug|Calcium Carbonate|3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
16362558|NCT00153816|Drug|Vitamin D3|1000 IU/daily; two tablets per day; 500 IU per tablet
16362559|NCT00153816|Drug|placebo|placebo; two tablets per day
16362560|NCT00153803|Drug|Erlotinib (tarceva)|Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
16362561|NCT00153803|Drug|Placebo|Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
16362562|NCT00153790|Drug|PhosphoLean|
16362563|NCT00153777|Drug|Cellulose Sulfate gel (6%)|
16362564|NCT00153764|Drug|Cooper Complete One-A-Day Vitamin Supplement|
16362565|NCT00153751|Drug|Traditional Chinese Medicine|They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
16362566|NCT00153751|Drug|Holopon|holopon
16362567|NCT00153751|Other|placebo|placebo
16362568|NCT00153738|Drug|phytosterol|
16362569|NCT00153725|Drug|Aspirin and Pantoloc|
16362570|NCT00153699|Drug|Topiramate|
16362571|NCT00153686|Procedure|capsule endoscopy|capsule endoscopy of small intestine
16362572|NCT00153686|Procedure|Mesenteric Angiogram|Mesenteric Angiogram
16362573|NCT00153673|Drug|celecoxib|Celecoxib 200mg bd
16362574|NCT00153673|Drug|Dologesics|Dologesics 2 tablets bd
16362575|NCT00153660|Drug|Celecoxib(drug)|Celecoxib 100 mg bd
16362576|NCT00153660|Drug|Naproxen(drug)|Naproxen 500 mg bd
16362577|NCT00153647|Procedure|Cap-assisted colonoscopy|Cap-assisted colonoscopy
16362578|NCT00153647|Procedure|Cap-assisted colonoscopy|Cap-assisted colonoscopy
16362579|NCT00153634|Drug|IV amikacin|5-7.5 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
16362580|NCT00153634|Drug|PO azithromycin|250 mg once daily
16362581|NCT00153634|Drug|IV ceftazidime|50 mg/kg every 8 hours, up to 2 grams every 8 hours
16362582|NCT00153634|Drug|PO ciprofloxacin|500 mg every 12 hours if weight <50 kg 750 mg every 12 hours if weight ≥50 kg
16362583|NCT00153634|Drug|IV meropenem|40 mg/kg every 8 hours, up to 2 grams every 8 hours
16362584|NCT00153634|Drug|IV piperacillin-tazobactam|100 mg/kg of piperacillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
16362585|NCT00153634|Drug|IV ticarcillin-clavulanate|100 mg/kg of ticarcillin component every 6 hours, up to 3 grams every 6 hours; antibiotic combination formulated in a fixed ratio, thus dosing is described for first component only
16362586|NCT00153634|Drug|IV tobramycin|2.5-3.3 mg/kg every 8 hrs or previous dose; start at previous recent stable dose then monitor serum levels and adjust dose, if needed, per standard clinical practice at the site
16362591|NCT00153556|Biological|Hib conjugate vaccine (HbOC, Wyeth Vaccines)|
16362592|NCT00153543|Biological|Pneumococcal polysaccharide vaccine|
16362593|NCT00153543|Biological|Pneumococcal conjugate vaccine|
16362594|NCT00153530|Drug|methotrexate|"chemotherapy with radiotherapy
~chemotherapy without radiotherapy"
16362595|NCT00153530|Radiation|radiotherapy|whole-brain irradiation
16362596|NCT00153517|Drug|oral versus vaginal metronidazole|
16362597|NCT00153504|Behavioral|Housing and Health Study housing rental assistance|
16362598|NCT00153504|Behavioral|Standard local practice housing assistance|
16362599|NCT00153491|Drug|artemether-lumefantrine|
16362600|NCT00153478|Behavioral|Brief Motivational Counseling|
16362601|NCT00153465|Behavioral|Motivational intervention, parent training|
16362602|NCT00153452|Behavioral|perpetration of intimate partner violence|
16362603|NCT00153439|Behavioral|Motivational enhancements, parent training|
16362604|NCT00153426|Behavioral|West Virginia WISEWOMAN|Print-based tailored health communications and computer-based interactive nutrition program
16362605|NCT00153413|Behavioral|Women's health|
16362606|NCT00153400|Behavioral|Women's health|
16362607|NCT00153387|Behavioral|Women's health|
16362608|NCT00153374|Behavioral|Women's health|
16362609|NCT00153361|Behavioral|Discussion Group|
16362610|NCT00153361|Behavioral|Video Discussion Group|
16362611|NCT00153348|Behavioral|Women's health|
16362612|NCT00153335|Behavioral|patient-provider interaction|
16362613|NCT00153322|Behavioral|Nurtition and Physical Activity Education|
16362614|NCT00153309|Behavioral|People with Arthritis Can Exercise|
16362615|NCT00153296|Drug|Carbamazepine|
16362616|NCT00153283|Drug|Gabapentin|
16362617|NCT00153270|Drug|Sodium Valproate|
16362618|NCT00153257|Device|Ugytex|Anterior repair reinforced by a specially designed mesh: UgytexTM
16362619|NCT00153244|Drug|Lamotrigine|
16362620|NCT00153231|Device|IVS|Infracoccygeal sacropexy
16362621|NCT00153231|Procedure|Sacrospinofixation|
16362622|NCT00153205|Behavioral|computerized physician order entry|
16362623|NCT00153192|Drug|Marinol (dronabinol)|
16362624|NCT00153179|Drug|acipimox|subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit
16362625|NCT00153179|Drug|placebo|matching placebo
16362626|NCT00153166|Drug|atorvastatin and pioglitazone|atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)
16362627|NCT00153166|Drug|atorvastatin/placebo|atorvastatin 80 mg orally once daily and matching placebo orally twice daily
16362628|NCT00153166|Drug|pioglitazone/placebo|pioglitazone 30 mg orally once daily and matching placebo orally once daily
16362629|NCT00153166|Drug|placebo/placebo|placebo orally three times daily
16362630|NCT00153153|Drug|polyethyleneglycol3350|
16362631|NCT00153140|Drug|polyethyleneglycol3350|
16362632|NCT00153127|Drug|polyethyleneglycol3350|
16362633|NCT00153114|Drug|polyethyleneglycol3350|
16362634|NCT00153101|Drug|Telmisartan|
16362635|NCT00153101|Drug|Combination of Telmisartan and Ramipril|
16362636|NCT00153101|Drug|Ramipril|
16362637|NCT00153088|Drug|Telmisartan capsule 40 mg|
16362638|NCT00153088|Drug|Placebo|
16362639|NCT00153088|Drug|Telmisartan capsule 80 mg|
16362640|NCT00153075|Device|Berodual Respimat|
16362641|NCT00153075|Device|Berodual HFA-MDI|
16362642|NCT00153062|Drug|Aggrenox|25mg aspirin, 200 mg dipyridamole
16362643|NCT00153062|Drug|Aggrenox|25mg aspirin, 200 mg dipyridamole
16362644|NCT00153062|Drug|Clopidogrel placebo|placebo
16362645|NCT00153062|Drug|Clopidogrel placebo|placebo
16362646|NCT00153062|Drug|Micardis|80 mg micardis
16362647|NCT00153062|Drug|Micardis|80 mg micardis
16362648|NCT00153062|Drug|Aggrenox placebo|placebo
16362649|NCT00153062|Drug|Aggrenox placebo|placebo
16362650|NCT00153062|Drug|Clopidogrel|75 mg clopidogrel
16362651|NCT00153062|Drug|Clopidogrel|75 mg clopidogrel
16362652|NCT00153062|Drug|Micardis placebo|placebo
16362653|NCT00153062|Drug|Micardis placebo|placebo
16362654|NCT00153049|Drug|Telmisartan|
16362655|NCT00153049|Drug|Hydrochlorothiazide|
16362656|NCT00153049|Drug|Telmisartan + Hydrochlorothiazide|
16362657|NCT00153036|Drug|rt-PA 0.9 mg/kg verum or placebo Intravenous|
16362658|NCT00153023|Drug|Telmisartan|
16362659|NCT00153023|Drug|Valsartan|
16362660|NCT00153010|Drug|NS 2330 (Tesofensine)|
16362661|NCT00152997|Drug|Pramipexole 0.125 mg tablets|
16362662|NCT00152997|Drug|Pramipexole 0.125 mg tablets Placebo|
16362663|NCT00152984|Drug|Tiotropium inhalation capsules|
16362664|NCT00152984|Drug|Placebo inhalation capsules|
16362665|NCT00152971|Drug|Dabigatran Dose 1 - day 2 to completion|low dose regimen taken once daily
16362666|NCT00152971|Drug|Dabigatran Dose 1 - day 1|low dose regimen taken once daily
16362667|NCT00152971|Drug|Dabigatran Dose 2 - day 2 to completion|high dose regimen taken once daily
16362668|NCT00152971|Drug|Dabigatran Dose 2 - day 1|high dose regimen taken once daily
16362669|NCT00152971|Drug|Enoxaparin|30 mg subcutaneously twice daily
16362670|NCT00152958|Drug|Pramipexole|
16362671|NCT00152945|Drug|Intravenous Intralipid|intravenous infusion
16362672|NCT00152945|Drug|Intravenous leucine, glycerol|intravenous infusion
16362673|NCT00152932|Drug|Dorzolamide 2% drops|
16362674|NCT00152932|Device|HRF and CLBF|
16362675|NCT00152919|Drug|Meloxicam|
16362676|NCT00152906|Procedure|Stereotactic radiotherapy (SRT) or highly conformal (CRT)|SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.
16362677|NCT00152893|Drug|chromium nicotinate|
16362678|NCT00152893|Drug|Placebo|
16362800|NCT00151996|Drug|Amphetamine + SPD503|
16362679|NCT00152867|Drug|Dexamethasone|dexamethasone 4mg PO bd for 2 days post chemotherapy
16362680|NCT00152854|Drug|Acetaminophen|acetaminophen 1g po qid
16362681|NCT00152854|Drug|acetaminophen|acetaminophen 1g po qid for 7 days
16362682|NCT00152854|Drug|placebo, sugar pill|
16362683|NCT00152841|Drug|Iron supplement 300-600 mg/day|
16362684|NCT00152841|Drug|Vitamin E 800IU|
16362685|NCT00152828|Drug|Celecoxib|
16362686|NCT00152815|Drug|antioxidant vitamin E|Vitamin E 800IU per day for 12 months
16362687|NCT00152815|Behavioral|weight reduction and exercise|Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.
16362688|NCT00152802|Biological|The polysaccharide vaccine Pneumovax (Merck-Frosst)|
16362689|NCT00152802|Biological|The conjugate vaccine used will be Prevnar (Wyeth vaccines)|
16362690|NCT00152789|Procedure|Oxygen measurement - Eppendorf machine|
16362691|NCT00152776|Drug|ovaria comp 10 globuli 3 times per day 24 weeks|order of intervention and placebo varies between Groups I-III
16362692|NCT00152763|Behavioral|Cognitive Behaviour Therapy (CBT)|Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
16362693|NCT00152763|Other|Usual Cardiac Care (UCC)|Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
16362694|NCT00152750|Drug|APO-clonidine|
16362695|NCT00152737|Procedure|Exercise test with Transcutaneous oxygene pressure|Ce marked devices
16362696|NCT00152737|Procedure|Ankle and arm pressure values|one test before and one test after surgery
16362697|NCT00152724|Device|pressure strain system, iontophoresis|
16362698|NCT00152724|Drug|scopolamin|
16362699|NCT00152724|Drug|emla|
16362700|NCT00152724|Drug|capsaicin|
16362701|NCT00152724|Drug|aspirin|
16362702|NCT00152724|Drug|clopidogrel|
16362703|NCT00152724|Drug|celecoxib|
16362704|NCT00152724|Drug|indomethacin|
16362705|NCT00152724|Drug|acetylcholine|
16362706|NCT00152724|Drug|sodium nitroprusside|
16362707|NCT00152724|Drug|brethyllium|
16362708|NCT00152724|Device|general and local heating|
16362709|NCT00152711|Device|nCPAP|
16362710|NCT00152698|Drug|Irbesartan|
16362711|NCT00152685|Drug|human serum albumin|
16362712|NCT00152672|Device|nCPAP vs oral appliance|
16362713|NCT00152659|Procedure|Tissue sample (procedure/screening)|Tissue sampling
16362714|NCT00152646|Drug|placebo, aspirine, clopidogrel|
16362715|NCT00152633|Drug|Losartan|
16362716|NCT00152633|Drug|Metoprolol|
16362717|NCT00152633|Drug|Losartan|Treatment with Losartan
16362718|NCT00152620|Drug|Dexamethasone|
16362719|NCT00152620|Drug|Methylprednisolone|
16362720|NCT00152607|Procedure|donor right hepatic lobectomy|
16362721|NCT00152594|Drug|voriconazole|
16362722|NCT00152581|Drug|Pegylated interferon-alfa2a (Pegasys); ribavirin|
16362723|NCT00152568|Behavioral|Car Seat Check (behavior)|At time of well child visit, family receives the services of a certified child passenger safety technician, including assessment, car seat distribution if needed and training.
16362724|NCT00152555|Behavioral|Physical Therapy or Relaxation Therapy|
16362725|NCT00152542|Drug|Inhaled nitric oxide|1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
16362726|NCT00152542|Drug|Placebo|No iNO given for days 1-7
16362727|NCT00152529|Behavioral|Screening (Behavior)|
16362728|NCT00152516|Drug|levetiracetam (LEV)|Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
16362729|NCT00152503|Drug|Seletracetam (ucb 44212)|
16362730|NCT00152490|Drug|Certolizumab Pegol (CDP870)|
16362731|NCT00152477|Drug|Carboplatin|"10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle.
~Each cycle to be repeated every three weeks for a maximum of six cycles."
16362732|NCT00152477|Drug|Paclitaxel|6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
16362733|NCT00152477|Drug|CDP791 10mg/kg|CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
16362734|NCT00152477|Drug|CDP791 20mg/kg|CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
16362735|NCT00152464|Drug|Placebo|Pharmaceutical form: Oral drops Route of administration: Oral use
16362736|NCT00152464|Drug|Levocetirizine|Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
16362737|NCT00152451|Drug|Seletracetam (ucb 44212)|
16362738|NCT00152438|Drug|Oral Micronized Progesterone (Prometrium®)|300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
16362739|NCT00152438|Other|Placebo|3 identical placebo pills daily, no active ingredient.
16362740|NCT00152425|Drug|Certolizumab Pegol (CDP870)|
16362741|NCT00152412|Drug|Levocetirizine oral solution|
16362742|NCT00152399|Drug|Somatostatin UCB (drug)|
16362743|NCT00152386|Drug|Certolizumab pegol (CDP870)|
16362744|NCT00152373|Drug|Levetiracetam|
16362745|NCT00152360|Drug|Orlistat|See Detailed Description.
16362746|NCT00152347|Drug|Botox|See Detailed Description
16362909|NCT00151125|Drug|recombinant interleukin-11|25 mcg/kg subcutaneously daily for seven days
16362747|NCT00152334|Drug|Botox|All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.
16362748|NCT00152321|Behavioral|Patients (education, counseling) and Physicians (reminders,1-page guidelines).|
16362749|NCT00152321|Behavioral|Multifaceted intervention|Educational materials, counseling, opinion leader based guidelines, reminders
16362750|NCT00152321|Other|Usual Care|
16362751|NCT00152308|Device|2% rapamycin-eluting YUKONdes PEARL-stent|
16362752|NCT00152308|Device|1% rapamycin-eluting YUKONdes PEARL-stent|
16362753|NCT00152308|Device|YUKONdes PEARL-stent coated with placebo (ethanol)|
16362754|NCT00152295|Drug|Asoprisnil/Premarin|10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
16362755|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
16362756|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
16362757|NCT00152282|Drug|Asoprisnil/Premarin|Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
16362758|NCT00152282|Drug|Placebo and Premarin|Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
16362759|NCT00152269|Drug|Asoprisnil|10mg Tablet, oral Daily for 12 months
16362760|NCT00152269|Drug|Asoprisnil|25mg Tablet, oral Daily for 12 months
16362761|NCT00152269|Drug|Placebo|Placebo, Tablet, oral Daily for 12 months
16362762|NCT00152256|Drug|Asoprisnil|Asoprisnil 10 mg Tablet, oral Daily for 6 months
16362763|NCT00152256|Drug|Asoprisnil|Asoprisnil 25mg Tablet, oral Daily for 6 months
16362764|NCT00152256|Drug|Placebo|Placebo Tablet, oral Daily for 6 months
16362765|NCT00152243|Drug|UFT (uracil, tegafur)|uracil-tegafur 360 mg per square meter per day orally 16 months
16362766|NCT00152243|Procedure|Surgery alone|Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
16362767|NCT00152230|Drug|UFT (uracil, tegafur)|to receive oral uracil-tegafur 400 mg square meter for one year
16362768|NCT00152230|Procedure|Surgery alone|Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
16362769|NCT00152217|Drug|TS-1 (S-1)|80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks
16362770|NCT00152217|Procedure|Surgery|Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only
16362771|NCT00152204|Drug|Sulfadoxine-pyrimethamine used for IPTi|Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
16362772|NCT00152204|Drug|IPTi|Doses of IPTi with SP delivered alongside doses 2 & 3 of DTP/HB vaccination and alongside measles vaccination
16362773|NCT00152191|Drug|UFT (uracil, tegafur)|uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
16362774|NCT00152191|Drug|cyclophosphamide, methotrexate, and fluorouracil|cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
16362775|NCT00152178|Drug|UFT (uracil, tegafur) and tamoxifen|UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
16362776|NCT00152178|Drug|CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen|CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.
16362777|NCT00152165|Procedure|Radiostereometric Analysis beads inserted during surgery|
16362778|NCT00152152|Procedure|Radiostereometric Analysis beads inserted during surgery|
16362779|NCT00152139|Procedure|Allogeneic Stem Cell Transplantation|An infusion of HLA matched unrelated bone marrow or peripheral blood stem cells.
16362780|NCT00152139|Drug|Chemotherapy and antibodies|Participants received a standard conditioning regimen consisting of total body irradiation, cyclophosphamide, thiotepa and ATG. GVHD prophylaxis consisted of cyclosporine and Methotrexate.
16362781|NCT00152126|Procedure|Stem Cell Transplantation|Autologous stem cell transplantation
16362782|NCT00152126|Drug|Busulfan, Melphalan|Transplant recipients will receive high dose Busulfan and Melphalan followed by autologous CD133+ antigen specific hematopoietic stem cell infusion. The autologous graft product will be selected using the investigational CliniMACS device.
16362783|NCT00152113|Procedure|Hematopoietic Stem Cell Transplantation|Allogeneic stem cell transplant Haploidentical stem cell transplant Mismatched family member donor stem cell transplant T cell selection CD34 enrichment
16362784|NCT00152113|Device|CliniMACS|
16362785|NCT00152113|Drug|See intervention description|Hydroxyurea and azathioprine were administered for a 3 month period prior to the initiation of the transplant procedure in an effort to help prevent rejection of the donor product. Approximately 10 days prior to the transplant procedure, all participants received the same preparative regimen consisting of Busulfan, cyclophosphamide, low-dose thiotepa, and OKT3. MMF was administered for GVHD prophylaxis. Two separate infusions of donor stem cells were administered with fixed doses of CD3 and CD34 cells. These haploidentical stem cells were processed using the investigational CliniMACS device.
16362786|NCT00152100|Procedure|Stem cell transplant|
16362787|NCT00152100|Drug|Filgrastim, Alemtuzumab|
16362788|NCT00152100|Device|Miltenyi CliniMACS|
16362789|NCT00152087|Device|Brachytherapy|
16362790|NCT00152074|Behavioral|Reduce salt intake|
16362791|NCT00152061|Drug|3TC and FTC|
16362792|NCT00152048|Drug|Eflornithine hydrochloride|
16362793|NCT00152035|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|
16362794|NCT00152022|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|
16362795|NCT00152009|Drug|SPD503 (Guanfacine hydrochloride) (2 mg)|
16362796|NCT00152009|Drug|SPD503 (3 mg)|
16362797|NCT00152009|Drug|SPD503 (4 mg)|
16362798|NCT00152009|Drug|Placebo|
16362799|NCT00151996|Drug|Methylphenidate + SPD503 (Guanfacine hydrochloride)|
16362801|NCT00151983|Drug|Methylphenidate Transdermal System|To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
16362802|NCT00151970|Drug|Methylphenidate Transdermal System|MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
16362803|NCT00151970|Drug|Placebo|Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
16362804|NCT00151970|Drug|Concerta|CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
16362805|NCT00151957|Drug|Methylphenidate Transdermal System|MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
16362806|NCT00151944|Drug|SPD476 (mesalazine)|
16362807|NCT00151931|Drug|Lanthanum carbonate|
16362808|NCT00151918|Drug|Lanthanum carbonate|
16362809|NCT00151905|Drug|3 % hypertonic saline|
16362810|NCT00151892|Drug|SPD476|2.4 g/day Once Daily (QD)
16362811|NCT00151892|Drug|Asacol|1.6g/day administered 800 mg Twice Daily (BID)
16362812|NCT00151879|Drug|SPM 927|
16362813|NCT00151866|Procedure|platelet transfusion|
16362814|NCT00151853|Drug|PPSB-SD|
16362815|NCT00151840|Drug|IVIG-L|
16362816|NCT00151827|Drug|Olmesartan medoxomil|Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
16362817|NCT00151827|Drug|Losartan|Medications are taken once daily before breakfast with water.
16362818|NCT00151827|Drug|Furosemide oral tablets|If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
16362819|NCT00151814|Drug|Olmesartan medoxomil|Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.
16362820|NCT00151801|Drug|estroprogestins|
16362821|NCT00151801|Drug|interferon-beta 1a|
16362822|NCT00151788|Drug|Pactimibe sulfate|
16362823|NCT00151775|Drug|olmesartan medoxomil|"Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension.
~Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily"
16362824|NCT00151775|Drug|placebo|Cohorts A, B, C: placebo, once daily
16362825|NCT00151775|Drug|olmesartan medoxomil|"Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly.
~Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg"
16362826|NCT00151762|Drug|Colesevelam hydrochloride|
16362827|NCT00151749|Drug|Colesevelam hydrochloride|
16362828|NCT00151736|Drug|Chlorambucil|Chlorambucil 2mg tablets
16362829|NCT00151736|Drug|R-etodolac + chlorambucil|R-etodolac 600mg tablets + chlorambucil 2mg tablets
16362830|NCT00151723|Procedure|treatment with 131I|
16362831|NCT00151710|Drug|Pioglitazone|
16362832|NCT00151697|Drug|Novomix 30|
16362833|NCT00151697|Drug|Novorapid and Amaryl|
16362834|NCT00151697|Drug|Lantus|
16362835|NCT00151684|Drug|Diazoxide|
16362836|NCT00151671|Drug|Oral Impact®|Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
16362837|NCT00151671|Drug|Placebo|Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
16362838|NCT00151658|Device|Coronary Drug Eluting Stents for PCI|
16362839|NCT00151645|Drug|activated lymphocytes|
16362840|NCT00151632|Drug|Mycophenolate mofetil|Mycophenolate mofetil is administered at a dose of 1,5 g x 2 / day for the 6 first weeks, then 1g x 2 / day until M12.
16362841|NCT00151632|Drug|Tacrolimus|"In arm 1: Tacrolimus is administered at half recommended dose: 0,040 mg/Kg x 2 , in order to maintain plasma levels between 6 and 10 ng/ml for the 6 first weeks, between 5 and 8 ng/ml from week 7 to M6 and between 4 and 6 ng/ml between M6 and M12.
~In arm 2: Tacrolimus is administered at the recommended dose: 0,075 mg/Kg x 2 , in order to maintain plasma levels between 12 and 20 ng/ml for the 6 first weeks, between 10 and 15 ng/ml from week 7 to week 12, between 8 and 12 ng/ml between M4 and M6 and between 6 and 10 ng/ml between M6 and M12."
16362842|NCT00151619|Drug|Amlodipine|
16362843|NCT00151606|Procedure|Reinforced isolation + Muciprocine|
16362844|NCT00151593|Other|Celsior®|Graft preservation solution
16362845|NCT00151580|Drug|Ribavirin|18 months of oral ribavirin maintenance treatment
16362846|NCT00151580|Drug|Placebo|18 months oral placebo treatment
16362847|NCT00151567|Drug|Tamsulosin|Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
16362848|NCT00151567|Drug|Placebo|Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
16362849|NCT00151554|Behavioral|ICU-specific information program|The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.
16362850|NCT00151541|Drug|Dapsone Topical Gel + adapalene gel 0.1%|
16362851|NCT00151541|Drug|Dapsone Topical Gel + benzoyl peroxide gel 4%|
16362852|NCT00151541|Drug|Dapsone Topical Gel + vehicle control|
16362853|NCT00151528|Drug|Pregabalin|
16362854|NCT00151515|Drug|minoxidil|Topical 5% minoxidil foam, BID, for sixteen weeks
16362855|NCT00151502|Drug|Atorvastatin|
16362856|NCT00151489|Drug|pregabalin|
16362857|NCT00151489|Drug|placebo|
16362858|NCT00151476|Drug|Celecoxib|800 mg total daily dosing
16362859|NCT00151476|Other|Routine Medical Care|
16362860|NCT00151463|Drug|sildenafil citrate|
16362861|NCT00151450|Drug|Pregabalin|
16362862|NCT00151450|Drug|Venlafaxine XR|
16362863|NCT00151437|Drug|Pegvisomant treatment|
16362864|NCT00151437|Procedure|Medical History, demographics|
16362865|NCT00151437|Procedure|Sign and symptoms: questionnaire|
16362866|NCT00151437|Procedure|Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT|
16362867|NCT00151437|Procedure|MRI|
16362868|NCT00151424|Drug|asenapine|Asenapine 5-10mgBID
16362869|NCT00151424|Drug|Placebo|Matched against asenapine and olanzapine
16362870|NCT00151424|Drug|Olanzapine|10-20 mg QD
16371852|NCT00003413|Drug|melphalan|
16362871|NCT00151411|Drug|Metformin|Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
16362872|NCT00151411|Drug|Placebo|Placebo
16362873|NCT00151411|Behavioral|Lifestyle Intervention|A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.
16362874|NCT00151398|Drug|lecozotan SR|"evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks.
~Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil."
16362875|NCT00151398|Drug|Donepezil|10 mg donepezil QD dosed up to 40 weeks
16362876|NCT00151385|Procedure|single blood draw|
16362877|NCT00151372|Behavioral|Treatment Adherence Intervention|The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.
16362878|NCT00151372|Behavioral|Enhanced Care|For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.
16362879|NCT00151359|Device|SoleSensor|
16362880|NCT00151346|Drug|Bupivacaine and Fentanyl (for CSE)|Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
16362881|NCT00151346|Drug|Bupivacaine and Fentanyl (for traditional epidural)|Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
16362882|NCT00151333|Drug|SRA-333|
16362883|NCT00151320|Drug|Bortezomib, CHOP, Rituximab|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
16362884|NCT00151307|Device|INVOS cerebral oximeter|
16362885|NCT00151294|Drug|escitalopram oxalate antidepressant|
16362886|NCT00151281|Drug|PEPC|"Induction phase (month 1-3)
~• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.
~Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• PEPC QOD or fractionated weekly basis"
16362887|NCT00151281|Drug|Thalidomide|"Induction phase (month 1-3)
~• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
~Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• Daily low dose thalidomide (50-100mg/d)"
16362888|NCT00151281|Drug|Rituximab|"Induction phase (month 1-3)
~• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
~Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
~Post-Month 12 Maintenance phase (post-month 12 until disease progression)
~• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
16362889|NCT00151255|Drug|Cytarabine|100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
16362890|NCT00151255|Drug|Idarubicin|12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
16362891|NCT00151255|Drug|All-trans retinoic acid|45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
16362892|NCT00151255|Drug|Mitoxantrone|10mg/m² i.v. day 2-3 (first consolidation cycle)
16362893|NCT00151255|Drug|Etoposid|100mg/m² i.v. Tag 1-5 (second consolidation cycle)
16362894|NCT00151242|Drug|Cytarabine|100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
16362895|NCT00151242|Drug|Idarubicin|12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
16362896|NCT00151242|Drug|Etoposide|100mg/m² i.v. day 1-3 (induction therapy)
16362897|NCT00151242|Drug|All-trans retinoic acid|45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
16362898|NCT00151242|Drug|Pegfilgrastim|6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
16362899|NCT00151229|Other|target blood pressure|
16362900|NCT00151216|Biological|AAV2CUhCLN2 (3x10^12 particle units)|gene transfer; one-time administration via neuro surgery procedure
16362901|NCT00151203|Drug|Clarithromycin, Lenalidomide, Dexamethasone|"Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle.
~Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1.
~Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles."
16362902|NCT00151190|Behavioral|Education for diabetes self-management|
16362903|NCT00151177|Device|non-invasive continuous positive airway pressure ventilation|
16362904|NCT00151177|Device|CPAP-treatment|night time CPAP-mask ventilation
16362905|NCT00151164|Procedure|donor bone marrow cell injection into thymus gland|
16362906|NCT00151151|Behavioral|Computer-Assisted Motivational Intervention|
16362907|NCT00151151|Behavioral|Didactic Educational Counseling|
16362908|NCT00151138|Drug|Atenolol (drug), Lisinopril (drug)|
16362910|NCT00151125|Drug|recombinant interleukin-11|50 mcg/kg subcutaneously daily for 7 days
16362911|NCT00151125|Drug|recombinant interleukin-11|10 mcg/kg subcutaneously daily for 7 days
16362912|NCT00151112|Procedure|Positioning and plexus anesthesia|positioning during plexus anesthesia
16362913|NCT00151099|Drug|high caloric drink with protein|
16362914|NCT00151086|Drug|Estramustine|
16362915|NCT00151086|Drug|Vinorelbine|
16362916|NCT00151073|Drug|Zoledronic acid|
16362917|NCT00151073|Drug|Estramustine|
16362918|NCT00151073|Drug|Docetaxel|
16362919|NCT00151060|Drug|Estramustine|
16362920|NCT00151060|Drug|Etoposide|
16362921|NCT00151060|Drug|Paclitaxel|
16362922|NCT00151047|Drug|Capecitabine|
16362923|NCT00151047|Drug|Docetaxel|
16362924|NCT00151034|Drug|Trastuzumab|
16362925|NCT00151034|Drug|Paclitaxel|
16362926|NCT00151034|Drug|Carboplatin|
16362927|NCT00151034|Drug|Gemcitabine|
16362928|NCT00151021|Behavioral|Tailored web-based walking program|
16362929|NCT00151008|Drug|Bexarotene/NBUVB vs placebo NBUVB|
16362930|NCT00150995|Drug|Tetrathiomolybdate|
16362931|NCT00150982|Drug|Mechanism of action of alefacept|
16362932|NCT00150969|Dietary Supplement|vitamin K1 (phylloquinone)|
16362933|NCT00150969|Dietary Supplement|placebo|1 pill daily
16362934|NCT00150956|Procedure|Daily home hemodialysis|
16362935|NCT00150943|Device|Renal artery stent|
16362936|NCT00150930|Device|narrowband UVB phototherapy at home|
16362937|NCT00150917|Behavioral|Supportive-Expressive Group Therapy|
16362938|NCT00150904|Procedure|venous blood puncture|
16362939|NCT00150891|Procedure|Kidney transplantation|
16362940|NCT00150891|Drug|cyclosporine A|
16362941|NCT00150891|Drug|tacrolimus|
16362942|NCT00150891|Drug|azathioprine|
16362943|NCT00150891|Drug|mycophenolate mofetil|
16362944|NCT00150878|Other|Conditioning therapy|Preparation before allogeneic transplantation
16362945|NCT00150865|Drug|ropivacaine|
16362946|NCT00150852|Drug|Vancomycin|
16362947|NCT00150839|Drug|Mirtazapine|Patients receive mirtazapine 45mg and placebo.
16362948|NCT00150839|Drug|Venlafaxine|Patients receive mirtazapine 45mg and venlafaxine 300mg.
16362949|NCT00150826|Drug|Quinapril|Quinapril will be started at 40mg daily and titrated to 80mg daily for 16 weeks.
16362950|NCT00150826|Drug|Placebo|Placebo will be given in a capsule form once daily for 16 weeks.
16362951|NCT00150813|Drug|Levetiracetam|Pharmaceutical form: oral tablets Route of administration: Oral use
16362952|NCT00150800|Drug|Brivaracetam|"Active Substance: Brivaracetam
~Pharmaceutical Form: Tablet
~Concentration: 10 mg and 25 mg
~Route of Administration: Oral"
16362953|NCT00150787|Drug|LEVETIRACETAM|
16362954|NCT00150774|Drug|Levetiracetam|
16362955|NCT00150761|Drug|Levocetirizine (drug)|
16362956|NCT00150748|Drug|Levetiracetam 166 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 166 mg
~Route of Administration: Oral use"
16362957|NCT00150748|Drug|Levetiracetam 250 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 250 mg
~Route of Administration: Oral use"
16362958|NCT00150748|Drug|Levetiracetam 500 mg|"Active Substance: Levetiracetam
~Pharmaceutical Form: Tablet
~Concentration: 500 mg
~Route of Administration: Oral use"
16362959|NCT00150735|Drug|LEVETIRACETAM|
16362960|NCT00150722|Drug|atorvastatin (or other tolerated statin + Niaspan/placebo)|atorvastatin 80 mg for all, randomized to 1500 mg niacin/placebo and then crossed over
16362961|NCT00150709|Drug|Levetiracetam (Keppra)|
16362962|NCT00150696|Drug|Risedronate|
16362963|NCT00150683|Device|vibration and passive standing versus passive standing alone|
16362964|NCT00150670|Drug|TS-1 and cisplatin|TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.
16362965|NCT00150670|Drug|TS-1|TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.
16362966|NCT00150657|Drug|bevacizumab|
16362967|NCT00150657|Drug|carboplatin|
16362968|NCT00150657|Drug|gemcitabine|
16362969|NCT00150644|Drug|Asoprisnil|Asoprisnil 10mg Tablet, oral Daily for 12 weeks
16362970|NCT00150644|Drug|Asoprisnil|Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
16362971|NCT00150644|Drug|Placebo|Placebo Tablet, oral Daily for 12 weeks
16362972|NCT00150631|Drug|Candesartan|placebo controlled double blind
16362973|NCT00150618|Drug|SPD503 (1 mg)|
16362974|NCT00150618|Drug|SPD503 (2 mg)|
16362975|NCT00150618|Drug|SPD503 (3 mg)|
16362976|NCT00150618|Drug|SPD503 (4 mg)|
16362977|NCT00150618|Drug|Placebo|
16362978|NCT00150605|Drug|Extended-release carbamazepine|
16362979|NCT00150592|Drug|SPD503 (Guanfacine HCl)|
16362980|NCT00150592|Drug|Placebo|
16362981|NCT00150579|Drug|Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate|
16362982|NCT00150566|Drug|Lanthanum carbonate|
16362983|NCT00150553|Drug|Extended-release carbamazepine|
16362984|NCT00150540|Drug|Lanthanum carbonate|
16362985|NCT00150527|Drug|Citalopram|40 mg, pill, single dose
16362986|NCT00150527|Drug|Escitalopram|20 mg, pill, single dose
16362987|NCT00150527|Drug|Dexamethasone|1 mg, pill, single dose
16362988|NCT00150527|Behavioral|Cold Pressor Test|single test
16362989|NCT00150514|Drug|Oralgen|
16362990|NCT00150514|Procedure|Nasal biopsy|
16362991|NCT00150514|Procedure|Nasal washing|
16362992|NCT00150514|Procedure|Peak nasal inspiratory flow|
16362993|NCT00150488|Device|Uracyst|2% weekly for 6 weeks, monthly for 4 months
16362994|NCT00150475|Procedure|Powered Air purifying respirator|
16362995|NCT00150462|Drug|Carfilzomib|Administered as an IV bolus dose
16362996|NCT00150462|Drug|Dexamethasone|Administered orally prior to carfilzomib
16362997|NCT00150449|Drug|Pregabalin|
16362998|NCT00150436|Drug|Pregabalin|
16362999|NCT00150423|Drug|Pregabalin|
16363000|NCT00150410|Drug|Inhaled insulin|
16363001|NCT00150397|Drug|Tofimilast|
16363002|NCT00150384|Drug|Amlodipine/Atorvastatin|
16363003|NCT00150371|Drug|atorvastatin|
16363004|NCT00150358|Drug|Sildenafil Citrate|
16363005|NCT00150345|Drug|voriconazole (Vfend)|voriconazole, early treatment
16363006|NCT00150345|Drug|voriconazole (Vfend)|voriconazole, deferred treatment
16363007|NCT00150332|Drug|linezolid|
16363008|NCT00150319|Drug|Vfend®; I.V.|
16363009|NCT00150306|Drug|Zoloft (Sertraline)|
16363010|NCT00150293|Drug|Pregabalin|
16363011|NCT00150280|Drug|celecoxib and ibuprofen SR|
16363012|NCT00150267|Drug|Xalacom|
16363013|NCT00150254|Drug|CP-526,555 (varenicline)|
16363014|NCT00150241|Drug|CP-526,555 (varenicline)|
16363015|NCT00150228|Drug|CP-526,555 (varenicline)|
16363016|NCT00150215|Drug|PF-00184562|
16363017|NCT00150215|Drug|Olanzapine|
16363018|NCT00150202|Drug|pegaptanib sodium|
16363019|NCT00150189|Behavioral|Sucrose|
16363020|NCT00150176|Drug|Asenapine - Open Label|Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
16363021|NCT00150176|Drug|Placebo - Double Blind|Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.
16363022|NCT00150176|Drug|Asenapine - Double Blind|Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
16363023|NCT00150150|Procedure|Interstitial laser photocoagulation|
16363024|NCT00150137|Drug|Methimazole|
16363025|NCT00150124|Drug|MTZ+LT4|
16363026|NCT00150124|Drug|Methimazole|
16363027|NCT00150111|Drug|Methimazole|
16363028|NCT00150111|Drug|Rituximab|
16363029|NCT00150111|Biological|Immunization with various vaccines|
16363030|NCT00150098|Behavioral|Enhanced HIV risk reduction and HIV vaccine education|
16363031|NCT00150085|Drug|cyclosporine micro-emulsion|
16363032|NCT00150072|Drug|imatinib|
16363033|NCT00150059|Drug|Pimecrolimus Cream 1%|
16363034|NCT00150046|Drug|Everolimus|
16363035|NCT00150020|Drug|Enteric-coated mycophenolate sodium (EC-MPS)|
16363036|NCT00150007|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16363037|NCT00149994|Drug|Cyclosporine A|
16363038|NCT00149994|Drug|Tacrolimus|
16363039|NCT00149994|Drug|Basiliximab|Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.
16363040|NCT00149994|Drug|Methylprednisolone|Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery
16363041|NCT00149994|Drug|Prednisone|Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
16363042|NCT00149981|Drug|everolimus (RAD)|Everolimus
16363043|NCT00149968|Drug|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
16363044|NCT00149942|Drug|Enteric-coated Mycophenolate sodium (EC-MPS)|
16363045|NCT00149929|Drug|Mycophenolate sodium (enteric coated)|
16363046|NCT00149916|Drug|Mycophenolate sodium (enteric coated)|
16363047|NCT00149903|Drug|Mycophenolate sodium (enteric coated)|
16363048|NCT00149890|Drug|Basiliximab|Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength.
16363049|NCT00149890|Drug|Cyclosporine/cyclosporine microemulsion|Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.
16363050|NCT00149890|Drug|Steroid|Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).
16363051|NCT00149877|Drug|Tegaserod|
16363052|NCT00149864|Drug|Mycophenolate sodium (enteric coated)|
16363053|NCT00149851|Drug|Tegaserod|
16363054|NCT00149838|Procedure|Prefrontal rTMS|Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
16363055|NCT00149838|Drug|Antidepressant Regimen|Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
16363056|NCT00149838|Procedure|Sham Stimulation|The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
16363057|NCT00149825|Drug|Escitalopram|5 to 20 mg for 12 weeks
16363058|NCT00149825|Behavioral|CBTI|Cognitive Behavioral Treatment for Insomnia
16363059|NCT00149825|Behavioral|CTRL|Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
16363060|NCT00149812|Behavioral|Family Functioning Intervention|
16363061|NCT00149799|Drug|Escitalopram|At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
16363198|NCT00148681|Drug|Navelbine|Intravenously every week for 12 weeks
16363199|NCT00148681|Drug|Doxorubicin|Every 3 weeks for 12 weeks
16363062|NCT00149799|Drug|Placebo|At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
16363063|NCT00149786|Behavioral|Family Based Therapy|Family therapy will be given for a total of 24 hours over the course of 12 months.
16363064|NCT00149786|Behavioral|Ego-Oriented Individual Psychotherapy|Individual therapy will be given for a total of 24 hours over the course of 12 months.
16363065|NCT00149773|Behavioral|Cognitive Therapy|
16363066|NCT00149760|Behavioral|Augmented Standard Medical Care|Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
16363067|NCT00149760|Behavioral|Cognitive-Affective Behavior Therapy|Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
16363068|NCT00149747|Behavioral|Moderate-Intensity Aerobic Physical Activity|Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
16363069|NCT00149747|Behavioral|Health Education Class|2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
16363070|NCT00149734|Drug|Ondansetron followed by placebo|Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
16363071|NCT00149734|Drug|Placebo followed by Ondansetron|Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
16363072|NCT00149721|Procedure|Ventriculo-peritonal shunting|
16363073|NCT00149708|Drug|growth hormone administration for 6 months|depot GH (Nutropin depot) 13.4 mg every 14 days
16363074|NCT00149695|Behavioral|Weekly home delivery of milk products|
16363075|NCT00149682|Behavioral|6-month educational program|
16363076|NCT00149682|Behavioral|6-month standard care program|
16363077|NCT00149669|Behavioral|employment-based reinforcement|Work Plus Naltrexone Contingency participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose.
16363078|NCT00149656|Dietary Supplement|Multivitamins|dietary supplement of multivitamins
16363079|NCT00149656|Dietary Supplement|Selenium|dietary supplement of selenium only
16363080|NCT00149656|Other|Placebo|placebo pill
16363081|NCT00149643|Drug|Fluoxetine|Gelatin capsules Fluoxetine 10 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20 mg, 2 capsules barring side effects.
16363082|NCT00149643|Other|Placebo|Gelatin capsules Placebo capsules, identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
16363083|NCT00149630|Drug|Disulfiram|Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15.
16363084|NCT00149630|Drug|Methadone|Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached.
16363085|NCT00149630|Behavioral|CBT|1-hour weekly, individual, manual-guided Cognitive Behaviorial Therapy.
16363086|NCT00149630|Other|Lactose|Lactose was added to both the active disulfiram and placebo doses so they tasted identical.
16363087|NCT00149617|Drug|Buspirone|
16363088|NCT00149604|Drug|conjugated estrogens|
16363089|NCT00149604|Drug|Raloxifene|
16363090|NCT00149604|Behavioral|exercise plus mild caloric restriction for weight loss|
16363091|NCT00149591|Procedure|coronary balloon-angioplasty with stenting|
16363092|NCT00149578|Drug|Gemcitabine Oxaliplatin 5FU and Leucovorin|
16363093|NCT00149565|Drug|IFN-α2b|
16363094|NCT00149552|Dietary Supplement|zinc|supplementation with zinc gluconate
16363095|NCT00149539|Drug|Buprenorphine/naloxone|
16363096|NCT00149526|Behavioral|Shared Decision-Making|
16363097|NCT00149513|Behavioral|Targeted Case Management|A nurse case manager will assess and follow intervention arm subjects for six months. Nurse case manager will help subjects acquire needed community health services.
16363098|NCT00149513|Behavioral|Usual care|Participants will receive usual care.
16363099|NCT00149500|Behavioral|Coaching|Patients received monthly calls to assist in behavioral change relative to asthma care
16363100|NCT00149487|Behavioral|Tailored Problem Solving Intervention|
16363101|NCT00149487|Behavioral|Family Education Intervention|
16363102|NCT00149474|Behavioral|Peak Flow Monitoring|
16363103|NCT00149461|Behavioral|Written Asthma Action Plan|
16363104|NCT00149448|Behavioral|TB Contact Priority Model|
16363105|NCT00149422|Device|NT-proBNP measurements|
16363106|NCT00149409|Dietary Supplement|Omacor|
16363107|NCT00149396|Drug|NV1020|NV1020 dose levels: 3x10^6, 1x10^7, 3x10^7, and 1x10^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks
16363108|NCT00149383|Drug|Rosiglitazone|
16363109|NCT00149383|Drug|Placebo|
16363110|NCT00149370|Procedure|Breast reduction surgery|
16363111|NCT00149357|Other|Thrombophilia Testing|TP testing in Group 1 and 3 only
16363112|NCT00149344|Radiation|Vertical scar versus inferior pedicle reduction mammoplasty|Vertical Scar Reduction Mammoplasty Inferior Pedicle Reduction Mammoplasty
16363113|NCT00149331|Behavioral|Structured education program|
16363114|NCT00149318|Other|Biochemical analyses.|Biochemical analyses.
16363115|NCT00149305|Other|Genetic analyses|
16363116|NCT00149305|Other|Genetic analyses|
16363117|NCT00149292|Drug|LY2140023|
16363118|NCT00149292|Drug|olanzapine|
16363119|NCT00149292|Drug|placebo|
16363120|NCT00149279|Procedure|Surgery: D2 dissection|
16363121|NCT00149279|Procedure|Surgery: D2+paraaortic dissection|
16363122|NCT00149266|Procedure|Surgery: abdominal and transhiatal approach|
16363123|NCT00149266|Procedure|Surgery: left thoraco-abdominal approach|
16363124|NCT00149253|Drug|a single-dose of Etoricoxib before induction of anesthesia|
16363125|NCT00149240|Biological|Botulinum toxin type A|
16363126|NCT00149227|Drug|Valsartan|Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.
16363127|NCT00149227|Drug|Non-ARB|'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
16363128|NCT00149214|Drug|pemetrexed|500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
16363129|NCT00149214|Drug|cyclophosphamide|600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
16363130|NCT00149214|Drug|doxorubicin|60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
16363131|NCT00149214|Drug|docetaxel|100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
16363132|NCT00149201|Drug|5-FU continuous infusion|
16363133|NCT00149201|Drug|MTX + 5-FU sequential therapy|
16363134|NCT00149188|Drug|Lanreotide (Autogel formulation)|
16363135|NCT00149175|Other|Blood sampling, skin biopsy|Blood sampling, skin biopsy in the field of the medical follow-up
16363136|NCT00149162|Drug|proleukin|"One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous)
~1 cycle of treatment each month during 12 months"
16363137|NCT00149149|Drug|Zinc carnosine|
16363138|NCT00149136|Drug|imatinib|
16363139|NCT00149123|Drug|hydrocortisone 200 mg/day|
16363140|NCT00149110|Procedure|Sleep deprivation|3 days with a normal night between
16363141|NCT00149110|Procedure|Light therapy|Daily light therapy for 29 weeks
16363142|NCT00149110|Procedure|Diurnal rhythms|Keeping the day-night cycle constant by use of educational measures
16363143|NCT00149110|Behavioral|Exercise|Moderate intensity daily exercise for 30 minutes at least
16363144|NCT00149110|Drug|duloxetine|60 mg daily
16363145|NCT00149110|Drug|duloxetine|60 mg daily
16363146|NCT00149084|Drug|Lansoprazole, clarithromycin, amoxicillin|
16363147|NCT00149071|Device|rTMS|15 treatments of rTMS active with a duration of 30 minutes each
16363148|NCT00149071|Device|TMS|Transcraniel Magnetic Stimulation active and sham
16363149|NCT00149071|Device|rTMS|active Transcranial Magnetic Stimulation
16363150|NCT00149071|Device|rTMS|daily for three weeks
16363151|NCT00149058|Drug|Erythropoietin|
16363152|NCT00149032|Procedure|DLI sensitized against antigens expressed by the host.|
16363153|NCT00149019|Drug|Cell therapy with bispecific antibodies|
16363154|NCT00149006|Procedure|Cell therapy|
16363155|NCT00148993|Biological|Tumor Cell Vaccine|
16363156|NCT00148980|Device|DBM for creation of bone marrow microenvironment|
16363157|NCT00148967|Device|Implantable Cardioverter Defibrillator|
16363158|NCT00148954|Device|VITALITY 2 Implantable Cardioverter Defibrillator|VITALITY 2 ICD
16363159|NCT00148954|Device|Medtronic Implantable Cardioverter Defibrillator|Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
16363160|NCT00148941|Biological|SB213503 lot 1|SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
16363161|NCT00148941|Biological|SB213503 lot 2|SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
16363162|NCT00148941|Biological|SB213503 lot 3|SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
16363163|NCT00148941|Biological|Infanrix|Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
16363164|NCT00148941|Biological|IPOL|IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
16363165|NCT00148941|Biological|M-M-R II|M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
16363166|NCT00148928|Biological|P501-AS15 vaccine|
16363167|NCT00148915|Drug|ibandronate|
16363168|NCT00148915|Drug|Placebo|matching placebo
16363169|NCT00148902|Drug|lapatinib|lapatinib
16363170|NCT00148902|Drug|docetaxel|docetaxel
16363171|NCT00148889|Device|Deep brain stimulation (DBS)|Bilateral pallidal stimulation with an implanted DBS device
16363172|NCT00148876|Drug|Capecitabine|Capecitabine 2500 mg/m² orally day 1-14 q day 22
16363173|NCT00148876|Drug|Trastuzumab|Trastuzumab 6 mg/kg body weight every 3 weeks i.v.
16363174|NCT00148863|Drug|Peg-interferon alpha 2a (drug)|
16363175|NCT00148863|Drug|Ribavirin (drug)|
16363176|NCT00148863|Drug|Interferon gamma (drug)|
16363177|NCT00148850|Drug|Pioglitazone|
16363178|NCT00148837|Drug|Peg-interferon alpha 2b (drug)|
16363179|NCT00148837|Drug|Ribavirin (drug)|
16363180|NCT00148837|Drug|Prazosin (drug)|
16363181|NCT00148824|Biological|7-valent pneumococcal conjugate vaccine (vaccine)|
16363182|NCT00148824|Biological|23-valent pneumococcal conjugate vaccine (vaccine)|
16363183|NCT00148798|Drug|cetuximab + cisplatin + vinorelbine|cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
16363184|NCT00148798|Drug|cisplatin + vinorelbine|cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
16363185|NCT00148785|Drug|Indinavir/Ritonavir/Fosamprenavir|
16363186|NCT00148772|Drug|Erlotinib (Tarceva)|
16363187|NCT00148759|Drug|LPV/r|LPV/r 800/200 mg once daily
16363188|NCT00148746|Drug|Pimecrolimus|
16363189|NCT00148746|Drug|Tacrolimus|
16363190|NCT00148746|Drug|Prednisolone|
16363191|NCT00148746|Drug|Ciclosporin A|
16363192|NCT00148746|Drug|Dermatop|
16363193|NCT00148733|Drug|Zinc|Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
16363194|NCT00148720|Drug|Capecitabine|Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles
16363195|NCT00148707|Drug|CT-2103 (Xyotax)|
16363196|NCT00148694|Drug|Cisplatin|Intravenously once every three weeks for a total of 12 weeks
16363197|NCT00148681|Drug|Herceptin|Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
16363304|NCT00147875|Drug|Vinblastine|
16363200|NCT00148681|Drug|Cyclophosphamide|Intravenously every 3 weeks for 12 weeks
16363201|NCT00148681|Drug|Paclitaxel|Weekly for 12 weeks (or a similar schedule)
16363202|NCT00148668|Drug|Herceptin|One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
16363203|NCT00148668|Drug|Navelbine|Weekly injections given starting week 3 and ending week 14
16363204|NCT00148668|Drug|Taxotere|Given every three weeks starting week 3 and ending on week 14
16363205|NCT00148668|Drug|Carboplatin|Given every three weeks starting week 3 and ending on week 14
16363206|NCT00148655|Device|Decision Board|Decision board that explains the risks and benefits of treatment options
16363207|NCT00148642|Device|silver salts coated endotracheal tube|intubation with silver coated tube
16363208|NCT00148642|Device|uncoated endotracheal tube|intubation
16363209|NCT00148629|Drug|multivitamin, mebendazole|
16363210|NCT00148616|Drug|Memantine|Daily dosage of 20 mg Memantine add-on to Risperidone vs. Placebo add-on to Risperidone
16363211|NCT00148616|Drug|Placebos|Daily dosage of 20 mg Placebo add-on to Risperidone vs. Memantine add-on to Risperidone
16363212|NCT00148603|Drug|montelukast|
16363213|NCT00148590|Drug|Memantine|Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
16363214|NCT00148590|Drug|Placebo|Daily dose of 20 mg Memantine add-on to Risperidone vs Placebo add-on to Risperidone
16363215|NCT00148577|Device|Transcutaneous Electrical Nerve Stimulation|
16363216|NCT00148564|Drug|olanzapine|treatment with either Olanzapine or Ziprasidone
16363217|NCT00148564|Drug|Ziprasidone|treatment with either Olanzapine or Ziprasidone
16363218|NCT00148551|Drug|Triamcinolone Acetonide|
16363219|NCT00148538|Behavioral|Resistance and/or Aerobic Exercise|Resistance and/or Aerobic Exercise
16363220|NCT00148525|Behavioral|Social Cognitive Theory|6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory.
16363221|NCT00148525|Behavioral|goal system theory|This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system.
16363222|NCT00148512|Drug|1. Tesofensine (NS 2330)|
16363223|NCT00148499|Drug|Ambroxol hydrochloride (Mucoangin?)|
16363224|NCT00148499|Drug|benzocaine|
16363225|NCT00148486|Drug|NS 2330|
16363226|NCT00148473|Drug|Misoprostol|
16363227|NCT00148460|Drug|TNK-tPA|
16363228|NCT00148460|Drug|rt-PA|
16363229|NCT00148447|Drug|escitalopram|
16363230|NCT00148434|Behavioral|Patient-held guideline for hypertension|
16363231|NCT00148421|Drug|Darbepoetin alfa and Epoetin alfa|
16363232|NCT00148408|Drug|Montelukast|
16363233|NCT00148408|Behavioral|Education|
16363234|NCT00148395|Drug|Gemcitabine|
16363235|NCT00148395|Drug|Navelbine|
16363236|NCT00148395|Drug|Carboplatin|
16363237|NCT00148395|Drug|Cisplatin|
16363238|NCT00148395|Drug|Mitomycin|
16363239|NCT00148395|Drug|Ifosfamide|
16363240|NCT00148382|Drug|ATL-962|
16363241|NCT00148369|Drug|Safety observation|Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.
16363242|NCT00148356|Device|ZoMaxx™ Drug-Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16363243|NCT00148356|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16363244|NCT00148343|Device|Odstock Dropped-Foot Stimulator (ODFS)|Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
16363245|NCT00148343|Other|Conventional Standard of Care|Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
16363246|NCT00148343|Procedure|Traditional Physical Therapy Treatment|Traditional physical therapy treatment for 12 weeks.
16363247|NCT00148330|Drug|Triamcinolone acetate|When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia]) was injected into the vitreous under sterile conditions in a minor procedures area.
16363248|NCT00148317|Drug|Bortezomib|During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11
16363249|NCT00148317|Drug|dexamethasone|During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18
16363250|NCT00148317|Drug|liposomal doxorubicin|If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles
16363251|NCT00148317|Drug|cyclophoshamide|During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8
16363252|NCT00148317|Drug|filgrastim|During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9
16363253|NCT00148291|Drug|Patients were randomized to receive either docetaxel 60 mg/m2 on day 1 or vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.|
16363254|NCT00148278|Drug|norepinephrine and dobutamine|continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 70mmHg or more and dobutamine could be added as a continuous infusion when cardiac index was of less than 2.5 liters per squared meter of body surface
16363255|NCT00148278|Drug|epinephrine plus placebo of dobutamine|epinephrine was titrated to maintain a mean arterial pressure at 70mmHg or more and placebo of dobutamine was titrated in case of a cardiac index lower than 2.5 liters per squared meters of body surface
16363305|NCT00147875|Drug|Doxorubicin (Adriamycin)|
16363306|NCT00147875|Drug|Gemcitabine|
16363307|NCT00147862|Drug|Tranexamic Acid|
16363308|NCT00147849|Behavioral|mailing of printed educational materials|
16363256|NCT00148265|Drug|Triamcinolone acetate|Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.
16363257|NCT00148252|Drug|Mycophenolate mofetil withdrawal|
16363258|NCT00148252|Drug|Cyclosporione A withdrawal|
16363259|NCT00148239|Behavioral|Caregiver Only Intervention|A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
16363260|NCT00148239|Behavioral|Dual Treatment|Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
16363261|NCT00148239|Behavioral|Control|Participants given written educational materials at beginning of study; no treatment beyond this
16363262|NCT00148226|Behavioral|Decision Aid|
16363263|NCT00148174|Behavioral|Intensive telephone followup|Telephone calling
16363264|NCT00148148|Drug|caspofungin|
16363265|NCT00148148|Drug|liposomal amphotericin B|
16363266|NCT00148135|Drug|Carboplatin|
16363267|NCT00148135|Drug|Gemcitabine|
16363268|NCT00148135|Drug|Capecitabine|
16363269|NCT00148122|Drug|Docetaxel|Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
16363270|NCT00148122|Drug|Capecitabine|Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
16363271|NCT00148109|Drug|Cetuximab|The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes.
16363272|NCT00148109|Drug|Cetuximab|Cetuximab 400 mg/m2 over 120 min IV initial does followed by weekly Cetuximab 250 mg/m2 over 60 min
16363273|NCT00148096|Device|Mechanical Heat Recovery Ventilation|De-humidification without loss of heat
16363274|NCT00148083|Drug|Risperdal Consta (drug)|
16363275|NCT00148083|Behavioral|Social Skills Training|
16363276|NCT00148070|Drug|Docetaxel|You will then receive your first dose of docetaxel chemotherapy. It is put through your IV over 1-2 hours. you will receive docetaxel every 3 weeks in the Cancer Center Infusion area.
16363277|NCT00148070|Procedure|Erythromycin Breath Test (ERMBT)|you will have an erythromycin breath test, which is an experimental test which is used to estimate the amount of enzyme produced by your liver which can metabolize the chemotherapy, docetaxel. For this test, you go to the GCRC where you will receive an injection of erythromycin (an antibiotic) which is labeled with a very small amount of radioactive substance. 20 minutes later you will blow air from your mouth into a blue solution until it clears. Your doctors will calculate the dose of docetaxel to be given to you based on this blood test, on your body's albumin level (a protein determined on the blood test), and on your height and weight.
16363278|NCT00148057|Behavioral|Low-fat diet|
16363279|NCT00148044|Procedure|Blood sampling for determination of uremic toxins|
16363280|NCT00148031|Drug|Pegylated Interferon and Ribavirin|Both groups with receive the same medical intervention but offered at different locations
16363281|NCT00148031|Behavioral|Psychosocial|Assessment of the likelihood of HCV treatment initiation and completion
16363282|NCT00148031|Behavioral|On-site (MMT Clinic) HCV evaluation and treatment|Standard HCV treatment with Pegylated Interferon and Ribavirin
16363283|NCT00148031|Behavioral|Off-site HCV evaluation and treatment|Standard HCV treatment with Pegylated Interferon and Ribavirin
16363284|NCT00148018|Drug|Bortezomib|
16363285|NCT00148018|Drug|Dexamethasone|
16363286|NCT00148005|Procedure|Questionnaire and micturition and drinking diaries|
16363287|NCT00148005|Procedure|Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)|
16363288|NCT00148005|Behavioral|Adaptation of the drinking scheme|
16363289|NCT00148005|Drug|Anticholinergic therapy|
16363290|NCT00148005|Behavioral|Micturition clock|
16363291|NCT00147992|Procedure|Immediate loading of implants in totally edentate upper and lower jaw|Immediate loading of implants in totally edentate upper and lower jaw.
16363292|NCT00147979|Device|Bridging by PTFE with bounded heparin|Bridging by PTFE with bounded heparin
16363293|NCT00147979|Device|Bridging by PTFE without bounded heparin|Bridging by PTFE without bounded heparin
16363294|NCT00147966|Drug|rituximab|treatment with rituximab
16363295|NCT00147953|Drug|Rituximab|
16363296|NCT00147953|Procedure|Total nodal irradiation|
16363297|NCT00147940|Procedure|Acoustic rhinometry (procedure)|
16363298|NCT00147927|Behavioral|Sequential emails and web support|
16363299|NCT00147914|Drug|Cefdinir (drug)|cefdinir 300mg per orally twice daily for 10 days
16363300|NCT00147914|Drug|amoxicillin/clavulanate|1000mg /62.5mg extended release per orally twice daily for 10 days
16363301|NCT00147901|Drug|FCCam|After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
16363302|NCT00147888|Procedure|Acoustic rhinometry (procedure)|Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity.
16363303|NCT00147875|Drug|Prednisone|
16363309|NCT00147849|Behavioral|a combination of interactive educational meetings, educational outreach visits, and reminders|
16363310|NCT00147849|Behavioral|identification of local opinion leaders and establishment of local consensus processes|
16363311|NCT00147836|Drug|Human Insulin (Novolin-R, Novo Nordisk)|
16363312|NCT00147836|Device|H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland|
16363313|NCT00147836|Other|Pre-meal|
16363314|NCT00147836|Drug|Novolin-R|
16363315|NCT00147836|Drug|Human Insulin NPH (Novolin-N, Novo Nordisk)|
16363316|NCT00147836|Drug|Gliclazide (Diamicron, Servier)|
16363317|NCT00147836|Drug|Diamicron and Glucophage|
16363318|NCT00147823|Device|Vitoss Alone|Synthetic bone graft material
16363319|NCT00147823|Device|Vitoss with Bone Marrow Aspirate|Vitoss mixed with Bone Marrow aspirate
16363320|NCT00147810|Procedure|Telephone outreach to enhance asthma care|
16363321|NCT00147784|Drug|Ribavirin|800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
16363322|NCT00147784|Drug|Pegylated Interferon|180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks
16363323|NCT00147771|Drug|Imiquimod 5% cream|Treatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications.
16363324|NCT00147758|Drug|Colesevelam hydrochloride|
16363325|NCT00147745|Drug|Colesevelam|Colesevelam 3.8g for 12 weeks
16363326|NCT00147745|Drug|Colesevelam matching placebo|Colesevelam matching placebo for 12 weeks
16363327|NCT00147745|Drug|Insulin glargine (Lantus)|Insulin glargine for 12 weeks
16363328|NCT00147732|Radiation|Accelerated radiotherapy|68 Gy over 5.5 weeks
16363329|NCT00147732|Radiation|ARCON|68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
16363330|NCT00147719|Drug|Colesevelam hydrochloride|
16363331|NCT00147706|Procedure|Tailored Healthmedia programs on EHR Patient Portal|
16363332|NCT00147693|Behavioral|Diagnosis of caregivers' problems|
16363333|NCT00147693|Behavioral|Professional service: treatment of problems by counseling or practical support|
16363334|NCT00147680|Drug|Paclitaxel, Carboplatin|
16363335|NCT00147667|Drug|Erythromycin|
16363336|NCT00147654|Drug|Tolterodine ER 4 mg QD|
16363337|NCT00147654|Drug|Tamsulosin 0.4 mg QD|
16363338|NCT00147628|Drug|sildenafil citrate|
16363339|NCT00147628|Drug|placebo for sildenafil citrate|
16363340|NCT00147615|Drug|Eplerenone|
16363341|NCT00147602|Drug|atorvastatin|
16363342|NCT00147589|Drug|Eplerenone|
16363343|NCT00147576|Drug|CP-866,087|
16363344|NCT00147563|Drug|Eplerenone|
16363345|NCT00147550|Drug|PD-0325901|Administered orally either once or twice a day; several dosing schedules evaluated; current dosing schedule is 5 days on-drug, 2-days off drug for 3 weeks in a 28-day cycle. Doses evaluated ranged from 1 mg once a day to 30 mg twice daily.
16363346|NCT00147537|Drug|CP-751,871|"Phase 2 Arm A:
~CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles"
16363347|NCT00147537|Drug|paclitaxel|"Phase 2 Arm A:
~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
~Phase 2 Arm B:
~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles"
16363348|NCT00147537|Drug|carboplatin|"Phase 2 Arm A:
~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
~Phase 2 Arm B:
~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles"
16363349|NCT00147537|Drug|CP-751,871|Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
16363350|NCT00147537|Drug|paclitaxel|Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
16363351|NCT00147537|Drug|carboplatin|Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
16363352|NCT00147537|Drug|erlotinib|Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
16363353|NCT00147524|Drug|quinapril|
16363354|NCT00147524|Procedure|Laser Doppler imaging|
16363355|NCT00147511|Drug|linezolid|
16363356|NCT00147498|Drug|CP-690,550|Oral tablets administered at a dose of 5 mg BID for 6 weeks
16363357|NCT00147498|Drug|CP-690,550|Oral tablets administered at a dose of 15 mg BID for 6 weeks
16363358|NCT00147498|Drug|CP-690,550|30 mg BID for 6 weeks
16363359|NCT00147498|Other|Placebo|Placebo tablets
16363360|NCT00147485|Drug|AG-024322|
16363361|NCT00147472|Other|PET scan in addition to conventional CT imaging|PET scans, Pre and post radiation treatment
16363362|NCT00147459|Biological|HBV vaccine booster|
16363363|NCT00147446|Behavioral|Individual Stress Management|Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction.
16363364|NCT00147446|Other|Wait List Control|Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop.
16363365|NCT00147420|Drug|Zhi Byed 11|
16363366|NCT00147394|Drug|Risperidone|
16363367|NCT00147381|Drug|Alemtuzumab|"Day 0: Campath-1H 20 mg IV infusion over 3-6 hours
~Day 1: Campath-1H 20 mg IV infusion over 3-6 hours"
16363422|NCT00146835|Biological|Pediarix|1 or more injections
16363423|NCT00146835|Biological|Licensed DTPa containing vaccine|1 or more injections
16363424|NCT00146835|Biological|Prevnar®: (Wyeth)|Concomitant vaccination
16363425|NCT00146822|Device|ENDOTAK RELIANCE G lead|
16363368|NCT00147381|Drug|Tacrolimus|"Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml.
~till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
~Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months."
16363369|NCT00147381|Drug|Alemtuzumab|"Day 0: Campath-1H 30 mg IV infusion over 3-6 hours
~Day 1: Campath-1H 30 mg IV infusion over 3-6 hours"
16363370|NCT00147368|Drug|intravenous (IV) arginine|
16363371|NCT00147355|Drug|ondansetron, ibuprofen, paracetamol|ondansetron 4mg bid + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
16363372|NCT00147355|Drug|Ondansetron, ibuprofen, paracetamol|Ondansetron 4mg bid + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
16363373|NCT00147355|Drug|metoclopramide, ibuprofen, paracetamol|metoclopramide 10mg qds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
16363374|NCT00147355|Drug|Metoclopramide, codeine phosphate, ibuprofen, paracetamol|metoclopramide 10mg qds + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
16363375|NCT00147329|Drug|MM-093|
16363376|NCT00147316|Drug|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
16363377|NCT00147303|Drug|MCI-9042|
16363378|NCT00147290|Device|Implantable Cardiac Defibrillator|Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
16363379|NCT00147277|Device|Implantable Cardiac Defibrillator|Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
16363380|NCT00147264|Drug|Telmisartan (Micardis®) vs. Placebo|
16363381|NCT00147264|Behavioral|Low-Glycemic Index Diet vs. Control Diet|
16363382|NCT00147251|Drug|FDA approved drugs to treat blood pressure and cholesterol|
16363383|NCT00147238|Drug|Ferumoxtran-10 (USPIO)|Intravenous infusion of 2.6 mg/kg of ferumoxtran-10
16363384|NCT00147238|Procedure|MR lymphangiography|First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.
16363385|NCT00147225|Drug|AMG 531|"Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).
~1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)"
16363386|NCT00147225|Drug|Carboplatin|AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.
16363387|NCT00147225|Drug|Adriamycin|75-90 mg/m^2 IV
16363388|NCT00147225|Drug|Ifosfamide|10 gm/m^2 IV; OR, High dose ifosfamide = 14 gm/m^2.
16363389|NCT00147212|Drug|ET 743|ET-743 administered IV by 24-hr infusion every 3 weeks
16363390|NCT00147199|Drug|Inhaled treprostinil|Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
16363391|NCT00147199|Drug|Placebo inhalation solution|Doses are titrated to 9 breaths four times daily.
16363392|NCT00147186|Device|Hylan G-F 20|
16363393|NCT00147160|Drug|Temozolomide, Cisplatinum|
16363394|NCT00147147|Procedure|Gastrectomy with D2 or greater lymph node dissection|
16363395|NCT00147147|Drug|Gastrectomy+ chemotherapy|
16363396|NCT00147134|Procedure|open colectomy|Procedure/Surgery: open colectomy
16363397|NCT00147134|Procedure|laparoscopic colectomy|Procedure/Surgery: laparoscopic colectomy
16363398|NCT00147121|Drug|Rituximab + Standard CHOP|Rituximab + Standard CHOP
16363399|NCT00147121|Drug|Rituximab + Bi-weekly CHOP|Rituximab + Bi-weekly CHOP
16363400|NCT00147108|Device|ExAblate 2000|
16363401|NCT00147056|Device|ExAblate transcranial system|MRI-Guided Focused Ultrasound Feasibility Study for Brain
16363402|NCT00147043|Procedure|Leukapheresis|
16363403|NCT00147043|Procedure|Infusion of stem cells via image guided scan|
16363404|NCT00147030|Procedure|Whole body mild induced hypothermia|Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia
16363405|NCT00147004|Drug|hydrocortisone sodium succinate|50 mg intravenous bolus every six hours for 5 days, then tapered to 50 mg intravenously every 12 hours for days 6-8, 50 mg every 24 hours for days 9-11 and then stopped
16363406|NCT00147004|Drug|Placebo|
16363407|NCT00146978|Procedure|intra-arterial treatment|
16363408|NCT00146952|Device|Vibrotactile feedback|
16363409|NCT00146926|Drug|kétamine 20mg|
16363410|NCT00146926|Drug|ephedrine 3mg|
16363411|NCT00146926|Drug|lidocaine 40mg|
16363412|NCT00146913|Drug|Imatinib mesylate 600mg/day|
16363413|NCT00146913|Drug|Peg-Interféron at 90 microg/week|
16363414|NCT00146900|Procedure|Cognitive Behavioral Therapy|12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
16363415|NCT00146900|Procedure|Cognitive Therapy|12 weekly 1.5 hours weekly session of cognitive therapy without exposure
16363416|NCT00146900|Drug|Escitalopram|Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
16363417|NCT00146900|Other|Placebo|Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
16363418|NCT00146887|Procedure|coronary catheterization|
16363419|NCT00146874|Device|cardiac resynchronization therapy|
16363420|NCT00146861|Device|sensor programming|
16363421|NCT00146848|Device|Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices|"All subjects in this trial receive the same device. For the purpose of this trial, intervention is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm."
16363427|NCT00146796|Device|Rapid diagnostic test for malaria|
16363428|NCT00146783|Drug|Sulphadoxine-pyrimethamine|
16363429|NCT00146783|Drug|Sulphadoxine-pyrimethamine, amodiaquine|
16363430|NCT00146770|Biological|Aldurazyme|Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks
16363431|NCT00146770|Biological|Aldurazyme|0.58 mg/kg Aldurazyme every week for 208 weeks
16363432|NCT00146770|Biological|placebo|Placebo for 26 weeks
16363433|NCT00146757|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|100 U/kg every week
16363434|NCT00146757|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|200 U/kg every week (Week 26 onwards)
16363435|NCT00146744|Biological|Mtb72F/AS02A|
16363436|NCT00146731|Drug|SP|
16363437|NCT00146731|Drug|SP + amodiaquine|
16363438|NCT00146731|Drug|AQ + artesunate|
16363439|NCT00146731|Drug|chlorproguanil-dapsone|
16363440|NCT00146718|Drug|Amodiaquine and Sulphadoxine/Pyrimethamine|
16363441|NCT00146705|Procedure|blood samples are taken once|
16363442|NCT00146692|Behavioral|Free medical treatment|
16363443|NCT00146679|Behavioral|Psychoeducational Telephone counseling (TC)|Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
16363444|NCT00146679|Behavioral|Psychoeducational Intervention by Group (SG)|Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
16363445|NCT00146679|Behavioral|Usual Care|Usual Care provided by providers
16363446|NCT00146666|Device|Intermittent compression|
16363447|NCT00146640|Drug|MR Prednisone|Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.
16363448|NCT00146640|Drug|IR Prednisone|Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
16363449|NCT00146640|Drug|Placebo - MR Prednisone|Participants will receive placebo matching to MR prednisone tablet at bed time.
16363450|NCT00146640|Drug|Placebo - IR Prednisone|Participants will receive placebo matching to IR prednisone tablet in the morning.
16363451|NCT00146627|Drug|Eflornithine|
16363452|NCT00146627|Drug|Nifurtimox|
16363453|NCT00146614|Drug|Sirolimus|
16363454|NCT00146614|Drug|Tacrolimus|
16363455|NCT00146614|Drug|Methotrexate|
16363456|NCT00146614|Procedure|Stem Cell Transplantation|
16363457|NCT00146601|Drug|Fulvestrant|
16363458|NCT00146588|Drug|Cyclophosphamide|Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
16363459|NCT00146588|Drug|Epirubicin|Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
16363460|NCT00146588|Drug|Capecitabine|Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
16363461|NCT00146575|Device|Sirolimus-eluting stent (Cypher)|patients have been implanted a Cypher stent
16363462|NCT00146575|Device|Paclitaxel-eluting stent (Taxus)|patients have been implanted a Taxus stent
16363463|NCT00146562|Drug|Darbepoetin Alfa|Given day before chemotherapy of red blood cell count is below normal
16363464|NCT00146562|Drug|Pegfilgrastim|Given as an injection the day before chemotherapy for a total of 8 injections
16363465|NCT00146562|Drug|Paclitaxel|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
16363466|NCT00146562|Drug|Doxorubicin|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
16363467|NCT00146562|Drug|Cyclophosphamide|As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
16363468|NCT00146549|Drug|Trastuzumab|
16363469|NCT00146549|Drug|Vinorelbine|
16363470|NCT00146549|Drug|Paclitaxel|
16363471|NCT00146549|Drug|Docetaxel|
16363472|NCT00146523|Drug|Mifepristone|
16363473|NCT00146523|Drug|placebo|
16363474|NCT00146510|Behavioral|HealtheLifestyle Program|
16363475|NCT00146510|Behavioral|step counters with monthly feedback on logs|
16363476|NCT00146497|Drug|Budesonide-Surfactant|
16363477|NCT00146484|Drug|Twice Daily versus Three Times Daily Insulin Injections|
16363478|NCT00146471|Drug|Levetiracetam|1500-2000 mg daily add-on or Placebo Diazepam as needed
16363479|NCT00146471|Drug|Placebo|1500-2000 mg daily add-on or Placebo Diazepam as needed
16363480|NCT00146458|Procedure|18F-fluorodeoxyglucose positron emission tomography|
16363481|NCT00146445|Behavioral|Peer Mentoring Intervention|
16363482|NCT00146432|Procedure|Immunoadsorption of LPS, IL-6 and C5a|
16363483|NCT00146419|Behavioral|Reduction in behaviors capable of sexually transmitting HIV|Clinic-level risk reduction counseling
16363484|NCT00146406|Behavioral|Project Connect|
16363485|NCT00146393|Behavioral|People with Arthritis Can Exercise program|
16363486|NCT00146380|Drug|Zidovudine/Lamivudine and either Nevirapine or Nelfinavir|"Zidovudine 300mg po bid from 34 weeks gestation to 6 months postpartum Lamivudine 150mg po bid from 34 weeks gestation to 6 months postpartum AND EITHER Nevirapine 200mg po qd for 2 weeks as lead in then bid from 34 weeks gestation to 6 months postpartum OR Nelfinavir 1250mg po bid from 34 weeks gestation to 6 months postpartum
~ARVs continued for those that meet WHO treatment criteria"
16363487|NCT00146380|Behavioral|Breastfeeding for 6 months postpartum|Exclusive breastfeeding till five and one half months with rapid weaning over 2 weeks and cessation of breastfeeding at 6 months when ARVs are discontinued
16363488|NCT00146367|Behavioral|Active Living Every Day|
16363489|NCT00146354|Behavioral|Hospitalists Results Manager|
16363490|NCT00146341|Drug|Telmisartan/HCTZ|
16363491|NCT00146341|Drug|Telmisartan|
16363492|NCT00146328|Drug|Tipranavir|
16363493|NCT00146315|Behavioral|Supervised exercise on a stationary bicycle, 3-5 days a week|Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease
16363494|NCT00146315|Behavioral|Secondary prevention program for coronary heart disease|Secondary prevention program for coronary heart disease
16363495|NCT00146302|Biological|Bacille Calmette Guerin (BCG)|
16363496|NCT00146289|Drug|MICARDIS® (telmisartan)|
16363498|NCT00146263|Behavioral|Savyon|Computerized cognitive training
16363499|NCT00146263|Behavioral|Control|Usual activity
16363500|NCT00146250|Drug|Nitrous oxide|Substitution of Nitrous oxide for Nitrogen as balance gas in inspired gas mixture
16363501|NCT00146237|Drug|phenytoin|
16363502|NCT00146224|Drug|Epoetin alfa RB|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
16363503|NCT00146224|Drug|Epoetin alfa DT|Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
16363504|NCT00146211|Drug|Ethyl-EPA (Miraxion™)|
16363505|NCT00146198|Drug|ALGRX 4975|
16363506|NCT00146185|Drug|ALGRX 3268|
16363507|NCT00146172|Drug|neratinib|HKI-272
16363508|NCT00146159|Drug|Mitoxantrone|dosage
16363509|NCT00146146|Drug|testosterone undecanoate alone|1000 mg/12 weeks
16363510|NCT00146146|Drug|testosterone undecanoate plus letrozole|TU 1000 mg/12 weeks Letrozole 2.5 mg/day
16363511|NCT00146146|Drug|testosterone undecanoate plus dutasteride|TU 1000 mg/12weeks Dutasteride 0.5 mg/day
16363512|NCT00146133|Behavioral|diet, exercise|
16363513|NCT00146120|Drug|Idarubicin|
16363514|NCT00146120|Drug|Cytosin-Arabinosid|
16363515|NCT00146120|Drug|Etoposide|
16363516|NCT00146120|Drug|All-trans Retinoid acid|
16363517|NCT00146107|Behavioral|Diet|10 percent weight loss through diet and behavioral modification
16363518|NCT00146107|Other|Exercise|Multicomponent (resistance, aerobic, balance) exercise three times a week
16363519|NCT00146107|Other|Weight Loss and Exercise|10% weight loss through diet and exercise plus multicomponent exercise training three times a week
16363520|NCT00146094|Procedure|BMD Measurement|
16363521|NCT00146081|Behavioral|Weight Management|Participants (Index Participants) who identify 1 or 2 family members or friends (Co-Participants) to enroll with them are randomly assigned into either program A or B, and those who choose to enroll by themselves are randomly assigned to either program C or D. All Index Participants are invited to attend weekly group behavior change educational sessions; weekly in first 6 months, biweekly in next 6 months, and monthly in year 2. Co-Participants in program A are invited to attend all sessions with their Index Participant, but only the field workshops and personal counseling sessions if enrolled in program B.
16363522|NCT00146068|Drug|Avonex/Zocor|
16363523|NCT00146055|Procedure|Reduced intensity conditioning with allogeneic transplant|
16363524|NCT00146042|Drug|Docetaxel|
16363525|NCT00146042|Drug|Trastuzumab|
16363526|NCT00146042|Procedure|Erythromycin Breath Test (ERMBT)|
16363527|NCT00146016|Drug|Amantadine|
16363528|NCT00146003|Drug|Efalizumab treatment|
16363529|NCT00145990|Drug|methacholine|
16363530|NCT00145990|Device|KoKo Digidoser|
16363531|NCT00145990|Device|Rosethal Dosimeter|
16363532|NCT00145977|Drug|Alendronate|alendronate 70 mg once weekly
16363533|NCT00145977|Dietary Supplement|Calcium Citrate|600 mg of calcium citrate
16363534|NCT00145977|Dietary Supplement|Vitamin D|500 mg of Vitamin D consumed with the evening meal.
16363535|NCT00145951|Behavioral|motivational interviewing, brief advice in primary care|motivational interviewing, brief advice in primary care
16363536|NCT00145938|Drug|sildenafil|
16363537|NCT00145925|Drug|Perindopril-indapamide|
16363538|NCT00145925|Drug|Gliclazide MR-based glucose lowering|
16363539|NCT00145912|Behavioral|MI + CATCH-IT Internet Site|MI + CATCH-IT Internet Site
16363540|NCT00145912|Behavioral|BA (brief advice) + CATCH-IT Internet site|BA (brief advice) + CATCH-IT Internet site
16363541|NCT00145886|Drug|rhPTH|Subjects will be treated with rhPTH for 12 months.
16363542|NCT00145873|Drug|nesiritide, continuous infusion|
16363543|NCT00145847|Drug|Naltrexone or Placebo|Naltrexone or Placebo 50 mg per day
16363544|NCT00145834|Behavioral|community based trial|
16363545|NCT00145808|Device|Given® Diagnostic System|
16363546|NCT00145795|Drug|Kaletra + Current Dual NRTI Backbone|
16363547|NCT00145795|Drug|Current Regimen|
16363548|NCT00145782|Behavioral|Life style|
16363549|NCT00145769|Drug|Short Course Adjuvent Chemotherapy|Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
16363550|NCT00145769|Drug|Long Course Adjuvant Chemotherapy|Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
16363551|NCT00145769|Radiation|Short Course Radiotherapy|25 Gy in 5 fractions over 5 days.
16363552|NCT00145769|Radiation|Long Course Radiotherapy|50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
16363553|NCT00145769|Drug|Concurrent Chemotherapy|5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
16363554|NCT00145769|Procedure|Initial Surgery|Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for rectal cancer
16363555|NCT00145756|Drug|low sodium high potassium salt substitute|
16363556|NCT00145743|Behavioral|physio,pain,psychotherapy;social,nutrit.counselling&sports|profile and treatment recommendations based on the profile vs. routine psychooncology
16363557|NCT00145730|Drug|Ibuprofen|
16363558|NCT00145717|Drug|Plant sterol enriched milk tea|
16363559|NCT00145704|Drug|bisphosphonate therapy (risedronate)|Bisphosphonate therapy given to patients with growth hormone deficiency
16363560|NCT00145704|Dietary Supplement|Vitamin D supplement|Vitamin D given to patients with growth hormone deficiency
16363561|NCT00145704|Dietary Supplement|Calcium|calcium supplement given to patients with growth hormone deficiency
16363562|NCT00145691|Drug|Oxcarbazepine|
16363563|NCT00145678|Behavioral|Psychodynamic Therapy|Dynamic deconstructive psychotherapy is a time-limited (12-18 month) manual-based form of psychodynamic therapy that aims to remediate specific neurocognitive capacities responsible for processing of emotional experiences.
16363684|NCT00144625|Drug|MRA(Tocilizumab)|8mg/kg/4weeks
16363564|NCT00145678|Behavioral|Optimized Community Care|individual and group psychotherapy in a private practice, clinic, and/or rehab setting, with an eclectic orientation
16363565|NCT00145665|Procedure|FLT-PET scan|PET scan using FLT
16363566|NCT00145652|Drug|Neo-Recormon and Venofer|
16363567|NCT00145639|Drug|Ifosfamide, Carboplatin, Doxorubicin|See Detailed Description for treatment plan.
16363568|NCT00145639|Procedure|Limb Sparing|See Detailed Description for treatment plan.
16363569|NCT00145626|Drug|Chemotherapy and antibodies|Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.
16363570|NCT00145626|Device|Miltenyi Biotec CliniMACS|Stem cell selection device
16363571|NCT00145626|Procedure|Allogeneic stem cell transplantation|Allogeneic natural killer (NK)cell infusion
16363572|NCT00145613|Procedure|Stem Cell Transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
16363573|NCT00145613|Device|Miltenyi Biotec CliniMACS|stem cell selection device
16363574|NCT00145613|Drug|Systemic chemotherapy and antibodies|Transplant recipients received a non-TBI based reduced intensity conditioning regimen consisting of OKT-3, Fludarabine Thiotepa, and Melphalan. Rituximab was administered within 24 hours of the transplant in an effort to prevent PTLPD. In addition to T-cell depletion of the haploidentical stem cell product, Mycophenolate mofetil was provided as prophylaxis for GVHD.
16363575|NCT00145600|Drug|12 Week Stanford V Chemotherapy|12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children
16363576|NCT00145600|Drug|4 cycles of VAMP chemotherapy|4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.
16363577|NCT00145600|Drug|2 alternating cycles of VAMP/COP chemotherapy|2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.
16363578|NCT00145600|Drug|3 alternating cycles of VAMP/COP chemotherapy|3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT
16363579|NCT00145587|Procedure|Stem Cell Transplantation|An infusion of HLA partially matched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
16363580|NCT00145587|Device|Miltenyi Biotec CliniMACS|Stem cell selection device
16363581|NCT00145587|Drug|Systemic chemotherapy and antibodies|"Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning regimen consisting of OKT-3, Fludarabine, Thiotepa , and Melphalan followed by an infusion of a T-cell depleted donor stem cell product. Rituximab will be administered within 24 hours of the infusion in an effort to prevent post transplantation lymphoproliferative disorders (PTLPD). In addition to T-cell depletion of the donor product, cyclosporine will be provided as prophylaxis for (GVHD)Graft versus Host Disease
~Recipients of a matched sibling donor product will receive a myeloablative conditioning regimen consisting of busulfan and cyclophosphamide. Cyclosporine will be administered for GVHD prophylaxis."
16363582|NCT00145574|Drug|colesevelam HCl|Tablets
16363583|NCT00145574|Drug|placebo|Matching Tablets
16363584|NCT00145561|Drug|Saquinavir and Ritonavir|
16363585|NCT00145548|Device|Intra Bronchial Valve|
16363586|NCT00145535|Device|SOLX Titanium Sapphire Laser (TiSaLT)|Spot laser treatment, ~50 spots over 180°
16363587|NCT00145535|Device|Argon Laser Trabeculoplasty (ALT)|Spot laser treatment, ~50 spots over 180°
16363588|NCT00145522|Drug|17ß-Estradiol/Dydrogesterone|1/5 mg/day for 12 cycles of 28 days
16363589|NCT00145522|Drug|Tibolone|2,5 mg/day for 12 cycles of 28 days
16363590|NCT00145509|Drug|Asenapine|Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
16363591|NCT00145509|Drug|Placebo|Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
16363592|NCT00145496|Drug|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
16363593|NCT00145496|Drug|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
16363594|NCT00145483|Drug|Sildenafil|
16363595|NCT00145470|Drug|Asenapine|Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
16363596|NCT00145470|Drug|Placebo|Placebo fast dissolving SL tablets, BID
16363597|NCT00145457|Procedure|Blood sample|
16363598|NCT00145457|Procedure|Radiography|
16363599|NCT00145444|Drug|olanzapine|
16363600|NCT00145444|Drug|ziprasidone|
16363601|NCT00145431|Drug|torcetrapib/atorvastatin|
16363602|NCT00145431|Drug|atorvastatin|
16363603|NCT00145431|Drug|fenofibrate|
16363604|NCT00145418|Drug|Oxaliplatin + Docetaxel|Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
16363605|NCT00145405|Drug|Lanreotide Autogel and Octreotide LAR|
16363606|NCT00145379|Drug|Tablet Metformin 500 mg|
16363607|NCT00145379|Drug|Placebo|
16363608|NCT00145366|Drug|Recombinant human thyrotropin (Thyrogen)|
16363609|NCT00145353|Drug|Insulin NovoRapid versus Actrapid|
16363610|NCT00145340|Drug|pioglitazone|30 Mg/day
16363611|NCT00145327|Drug|Zoledronic Acid|Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
16363612|NCT00145327|Drug|Placebo|100 mL physiologic 0.9% normal saline for intravenous infusion.
16363613|NCT00145314|Drug|FLOX (5-fluorouracil/folinic acid/oxaliplatin)|FLOX every 2nd week
16363614|NCT00145314|Drug|FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab|FLOX every 2nd week Cetuximab weekly
16363615|NCT00145314|Drug|FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab|"FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.
~Cetuximab weekly."
16363616|NCT00145301|Drug|Lumiracoxib|
16363617|NCT00145275|Drug|zoledronic acid|
16363618|NCT00145262|Procedure|Autologous Bone Marrow Mononuclear Cell Implantation|
16363619|NCT00145249|Drug|Amphotericin B|Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days.
16363620|NCT00145249|Drug|Fluconazole|Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily.
16363621|NCT00145236|Drug|Nebivolol|
16363622|NCT00145210|Drug|Nebivolol and Atenolol|
16363623|NCT00145197|Behavioral|Improving the Delivery of Effective Care to Minorities|The intervention consists of: a) reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will recruit all physicians who treat patients with early stage breast cancer. Physicians who agree to participate will identify a point person in their office who will inform the research team if the patient has a follow up appointment with radiation or medical oncologists. Following the appointment date, we will contact each office to confirm the patient's visit. If the patient has connected with radiation and/or medical oncologist, we will let the surgeon's office know and stop calling his/her office. However, if the patient has not made the appropriate visits, we will continue to call the surgeon's office every week for a total of 3 calls to let them know that the patient has not connected with the oncologist.
16363624|NCT00145184|Dietary Supplement|Multivitamin supplement containing vitamins B, C, and E|A daily oral dose of between 1.5 to 3 times the age- appropriate Recommended Dietary Allowance (RDA) of each vitamin taken for two months starting at enrollment.
16363625|NCT00145184|Drug|Placebo|Placebo pill taken orally once per day for two months starting at enrollment.
16363626|NCT00145171|Drug|apomorphine HCl injection|
16363627|NCT00145158|Biological|8 HLA-A2 restricted peptides and Montanide ISA-51|
16363628|NCT00145145|Biological|MAGE-3.A1 peptide and CpG 7909|
16363629|NCT00145132|Procedure|β-CIT-SPECT, Neurophysiology|β-CIT-SPECT scans and EEG recordings, two assessments each
16363630|NCT00145106|Drug|Tazarotene 0.1% gel + placebo capsule, Oral minocycline (100 mg capsule) + vehicle gel, Tazarotene 0.1% gel + oral minocycline (100 mg capsule)|
16363631|NCT00145093|Drug|Baker's yeast (Bio Chromium)|
16363632|NCT00145080|Behavioral|Disease Management Assessment|
16363633|NCT00145067|Behavioral|Disease Management Assessment|
16363634|NCT00145054|Behavioral|MoodHelper Internet program for Depression Self-Help|
16363635|NCT00145041|Drug|Vincristine Sulfate Liposomes Injection|Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
16363636|NCT00145028|Drug|Carboplatin|
16363637|NCT00145015|Behavioral|Increased dietary intake of salmon or cod|
16363638|NCT00145002|Drug|VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis|
16363639|NCT00145002|Drug|biweekly-CHOP with G-CSF and intrathecal prophylaxis|
16363640|NCT00144989|Drug|Etoposide and cisplatin after chemoradiotherapy|Etoposide and cisplatin after chemoradiotherapy
16363641|NCT00144989|Drug|Irinotecan and cisplatin after chemoradiotherapy|Irinotecan and cisplatin after chemoradiotherapy
16363642|NCT00144976|Drug|Tarceva|Tarceva will be administered at dosage 150 mg od one hour before or two hours after meat. Patients will receive Tarceva between 18 and 28 days.
16363643|NCT00144963|Drug|Vincristine Sulfate Liposomes Injection|Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
16363644|NCT00144963|Drug|Dexamethasone|Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
16363645|NCT00144950|Drug|insertion of a chest drain with urokinase instillation|
16363646|NCT00144950|Procedure|primary video-assisted thorascopic surgery|
16363647|NCT00144937|Drug|Stepwise therapy for dyslipidemia, hypertension and diabetes|
16363648|NCT00144937|Behavioral|Dietary recommendations|
16363649|NCT00144937|Behavioral|Increase in physical activity|
16363650|NCT00144937|Behavioral|Smoking cessation|
16363651|NCT00144924|Procedure|pyloromyotomy|laparoscopic pyloromytomy
16363652|NCT00144911|Drug|Salmeterol|
16363653|NCT00144911|Drug|Fluticasone Propionate/Salmeterol Combination Product|
16363654|NCT00144898|Procedure|Sentinel Node Resection|Sentinel Node Resection
16363655|NCT00144898|Procedure|Conventional Axillary Dissection|Conventional Axillary Dissection
16363656|NCT00144885|Behavioral|Modification of therapy|Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results
16363657|NCT00144872|Drug|Lamotrigine|Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
16363658|NCT00144859|Drug|SB681323|
16363659|NCT00144846|Drug|albuterol sulfate inhalation aerosol|
16363660|NCT00144833|Drug|fosamprenavir/ritonavir (700mg/100mg BID)|
16363661|NCT00144833|Drug|fosamprenavir/ritonavir (1400mg/100mg BID)|
16363662|NCT00144833|Drug|fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)|
16363663|NCT00144820|Drug|Injection of Hyaluronan or Saline|
16363664|NCT00144807|Drug|rituximab|
16363665|NCT00144807|Drug|doxorubicin|
16363666|NCT00144807|Drug|cyclophosphamide|
16363667|NCT00144807|Procedure|autologous stem cell transplantation|
16363668|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|0.58 mg/kg every week
16363669|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.2 mg/kg every week
16363670|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.2 mg/kg every other week
16363671|NCT00144781|Biological|Aldurazyme (Recombinant Human Alpha-L-Iduronidase)|1.8 mg/kg every other week
16363672|NCT00144768|Drug|laronidase|dose of 0.58mg/kg body weight IV every week
16363673|NCT00144755|Drug|Darbepoetin alfa|prophylactic administration of darbepoetin alfa in experimental arm
16363674|NCT00144729|Procedure|Bone marrow transplant|
16363675|NCT00144716|Device|Insect Repellent plus Insecticide Treated Net|
16363676|NCT00144703|Drug|Sirolimus|
16363677|NCT00144703|Drug|Tacrolimus|
16363678|NCT00144690|Drug|E2007 (perampanel)|
16363679|NCT00144690|Drug|Placebo|
16363680|NCT00144677|Drug|sirolimus|
16363681|NCT00144677|Drug|tacrolimus|
16363682|NCT00144664|Drug|MRA(Tocilizumab)|
16363683|NCT00144651|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks for 1 year
16363821|NCT00143507|Drug|Placebo|
16363685|NCT00144612|Drug|MRA(Tocilizumab)|8mg/kg/2weeks
16363686|NCT00144599|Drug|MRA(Tocilizumab)|
16363687|NCT00144599|Drug|placebo|
16363688|NCT00144586|Drug|MRA(Tocilizumab)|8mg/kg/4 weeks
16363689|NCT00144573|Drug|MRA(Tocilizumab)|
16363690|NCT00144560|Drug|MRA(Tocilizumab)|
16363691|NCT00144547|Drug|MRA(Tocilizumab)|8mg/kg(i.v.)/4weeks
16363692|NCT00144534|Drug|MRA (Tocilizumab)|8mg/kg/4 weeks
16363693|NCT00144521|Drug|MRA(Tocilizumab)|8mg/kg/4week(i.v.)for 24 weeks
16363694|NCT00144521|Drug|MRA placebo|0mg/kg/4week(i.v.) for 24 weeks
16363695|NCT00144521|Drug|MTX|8mg/week(p.o.) for 24 weeks
16363696|NCT00144521|Drug|MTX placebo|0mg/week(p.o.) for 24 weeks
16363697|NCT00144508|Drug|MRA (Tocilizumab)|8mg /kg /4week for 52 weeks
16363698|NCT00144508|Other|current treatment|continue current treatment
16363699|NCT00144495|Drug|recombinant human erythropoietin|3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
16363700|NCT00144495|Drug|recombinant human erythropoietin|36000IU(s.c.)/week for 12 weeks
16363701|NCT00144482|Drug|recombinant human erythropoietin|36000IU（0.5mL）s.c./week for 8 weeks
16363702|NCT00144482|Drug|recombinant human erythropoietin placebo|0 IU(0.5mL)s.c./week for 8 weeks
16363703|NCT00144469|Drug|peginterferon alfa-2a|
16363704|NCT00144469|Drug|rivavirin|
16363705|NCT00144456|Drug|ED-71|0.75μg/day(p.o.)for 144 weeks
16363706|NCT00144456|Drug|Alfacalcidol|1.0μg/day(p.o.)for 144 weeks
16363707|NCT00144456|Drug|ED-71 placebo|0 μg/day(p.o.)for 144 weeks
16363708|NCT00144456|Drug|Alfacalcidol placebo|0 μg/day(p.o.)for 144 weeks
16363709|NCT00144443|Behavioral|Basic home repair|
16363710|NCT00144443|Behavioral|Asthma Trigger Education|
16363711|NCT00144430|Drug|Pentostatin|The drug, Pentostatin, is given every 2 weeks. This drug will be given by intravenous (IV) infusion.
16363712|NCT00144417|Drug|Moxifloxacin (with rifampin, pyrazinamide, and ethambutol)|Moxifloxacin 400mg daily, 8 weeks
16363713|NCT00144417|Drug|isoniazid|isoniazid, oral, 300 mg, daily, 8 weeks
16363714|NCT00144391|Drug|Transdermal Testosterone gel|2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
16363715|NCT00144378|Drug|Irinotecan|
16363716|NCT00144365|Drug|Antiretroviral therapy|
16363717|NCT00144352|Drug|sulfadoxine-pyrimethamine|
16363718|NCT00144339|Drug|tiotropium|
16363719|NCT00144339|Drug|placebo|
16363720|NCT00144326|Drug|Tiotropium Bromide|
16363721|NCT00144326|Drug|Placebo|
16363722|NCT00144313|Biological|hepatitis B vaccine|
16363723|NCT00144300|Drug|Mirapex|Standard marketed product dispensed according to manufacturer's guidelines
16363724|NCT00144300|Drug|Requip|Standard marketed product dispensed according to manufacturer's guidelines
16363725|NCT00144287|Drug|Tipranavir/Ritonavir|
16363726|NCT00144274|Drug|Ambroxol Lozenge|
16363727|NCT00144261|Drug|nevirapine|
16363728|NCT00144248|Drug|nevirapine|
16363729|NCT00144235|Drug|Pharmaton PHL 00749|
16363730|NCT00144235|Drug|Placebo|
16363731|NCT00144222|Drug|Telmisartan 40 mg/HCTZ 12.5 mg|
16363732|NCT00144222|Drug|Telmisartan 40 mg|
16363733|NCT00144209|Drug|pramipexole|
16363734|NCT00144209|Drug|levodopa in combination with benserazide|
16363735|NCT00144196|Drug|tiotropium (Spiriva)|
16363736|NCT00144183|Drug|Nevirapine (NVP)|Nevirapine 200mg once daily for 14 days followed by 200mg twice daily thereafter for the remainder of the treatment period. Combivir®, one tablet twice daily.
16363737|NCT00144183|Drug|Zidovudine (ZCV)|
16363738|NCT00144183|Drug|3TC|
16363739|NCT00144170|Drug|Tipranavir (with low dose ritonavir)|
16363740|NCT00144170|Drug|Comparator protease inhibitor(CPI)/low dose ritonavir(r)|
16363741|NCT00144157|Drug|Nevirapine|
16363742|NCT00144157|Drug|Zidovudine|
16363743|NCT00144157|Drug|3TC|
16363744|NCT00144144|Drug|Angiotensin II receptor antagonists, Calcium channel blocker|
16363745|NCT00144131|Drug|Aranesp®|
16363746|NCT00144118|Drug|sevoflurane or isoflurane|
16363747|NCT00144105|Drug|TPV500mg/RTV200mgBID|
16363748|NCT00144105|Drug|TPV500mg/RTV100mgBID|
16363749|NCT00144105|Drug|LPV400mg/RTV100mgBID|
16363750|NCT00144092|Procedure|stem cell source|
16363751|NCT00144079|Procedure|external beam radiotherapy|
16363752|NCT00144066|Drug|platinum-based chemotherapy alone (up to six cycles)|
16363753|NCT00144066|Drug|platinum-based chemotherapy followed by maintenance therapy with gefitinib|
16363754|NCT00144053|Drug|Cisplatin+Vindesine+MMC/ concurrent radiation|
16363755|NCT00144053|Drug|Irinotecan+Carboplatin/concurrent radiation|
16363756|NCT00144053|Drug|Paclitaxel+Carboplatin/concurrent radiation|
16363757|NCT00144040|Behavioral|Physician & patient education on appropriate antibiotic use|
16363758|NCT00144040|Procedure|Rapid C-reactive protein testing to guide antibiotic treatment|
16363759|NCT00144027|Behavioral|Antipsychotic medication adherence intervention|The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.
16363760|NCT00144014|Drug|V10153|Single acute intravenous bolus dose up to 10 mg/kg
16363761|NCT00143988|Behavioral|Treadmill testing|Patients will have a exercise stress test using a Bruce protocol during which time heart rates and blood pressures will be monitored and the patient's percieved exertion level monitored and recorded
16363762|NCT00143988|Behavioral|Ambulatory Blood Pressure and Heart Rate Monitoring|Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.
16363763|NCT00143975|Drug|Cytarabine|3 g/m2 bid. i.v day 1-3
16363764|NCT00143975|Drug|Mitoxantrone|12 mg/m2 i.v. day 2 and 3
16363765|NCT00143975|Drug|Gemtuzumab Ozogamicin|3mg/m² i.v. day 1
16363766|NCT00143975|Drug|All-trans-Retinoid Acid|45 mg/m2 p.o. day 4-6 15 mg/m2 p.o. day 7-28
16363767|NCT00143962|Behavioral|Low Carbohydrate Diet|
16363768|NCT00143949|Drug|enalapril|
16363769|NCT00143949|Drug|losartan|
16363770|NCT00143936|Behavioral|Low- Carbohydrate -Atkins Diet|Low Carbohydrate Diet
16363771|NCT00143936|Behavioral|Low Calorie Diet|Maintain a low calorie diet
16363772|NCT00143923|Behavioral|Nutrition, Exercise, Stress Management Counseling|Individualized advice
16363773|NCT00143923|Other|usual care|usual care
16363774|NCT00143910|Other|observation|
16363775|NCT00143884|Procedure|Reduced intensity conditioning|
16363776|NCT00143884|Procedure|Prophylactic donor leukocyte infusions|
16363777|NCT00143871|Drug|Rituximab|
16363778|NCT00143858|Device|Pulse Volume Measurement|patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww
16363779|NCT00143845|Procedure|Reduced intensity conditioning|Busulfan and Fludarabine regimen
16363780|NCT00143845|Procedure|Rapid immunosuppressive taper|Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil
16363781|NCT00143845|Procedure|Prophylactic donor leukocyte infusions|If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.
16363782|NCT00143819|Drug|Neuroskin Forte|Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
16363783|NCT00143819|Drug|Placebo Application|Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
16363784|NCT00143806|Drug|Transitioning patients from cyclosporine to alefacept|
16363785|NCT00143780|Biological|The polysaccharide vaccine used is Pneumovax (Merck vaccines)|
16363786|NCT00143780|Biological|The conjugate vaccine used is Prevnar (Wyeth-Ayerst vaccines)|
16363787|NCT00143754|Procedure|Hydration|
16363788|NCT00143741|Drug|Atorvastatin (Lipitor)|20mg every day, taken by mouth. Dose could be increased up to 60mg every day during the course of the trial if tests indicate this is needed.
16363789|NCT00143728|Drug|Lamivudine|See Detailed Description.
16363790|NCT00143715|Drug|Phytonadione (Vitamin K1)|1.25 mg given orally
16363791|NCT00143702|Drug|d4T|See Detailed Description.
16363792|NCT00143702|Drug|Abacavir|See Detailed Description.
16363793|NCT00143702|Drug|Riboflavin and Thiamine (Supplementation)|See Detailed Description.
16363794|NCT00143689|Drug|lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine|See Detailed Description.
16363795|NCT00143676|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
16363796|NCT00143676|Drug|Lapaquistat acetate and atorvastatin|Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
16363797|NCT00143676|Drug|Atorvastatin|Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
16363798|NCT00143663|Drug|Lapaquistat Acetate|Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks
16363799|NCT00143663|Drug|Placebo|Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks
16363800|NCT00143650|Behavioral|House dust|
16363801|NCT00143637|Other|Office dust|airborne office dust spiked with glucan
16363802|NCT00143637|Other|clean air|Clean air
16363803|NCT00143624|Drug|Rosiglitazone maleate|See Detailed Description.
16363804|NCT00143624|Drug|Placebo|See detailed description.
16363805|NCT00143611|Drug|Resatorvid|Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.
16363806|NCT00143611|Drug|Resatorvid|Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.1 mg/kg/h (2.4 mg/kg/day), injection, subcutaneously over 96 hours.
16363807|NCT00143611|Drug|Placebo|Resatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
16363808|NCT00143598|Device|Knee-length, graduated elastic compression stocking|Worn daily for 2 years, 30-40 mm Hg
16363809|NCT00143598|Device|Knee-length, placebo stocking|Worn daily for two years
16363810|NCT00143585|Procedure|intramyocardial delivery of either VEGF165 or placebo|
16363811|NCT00143572|Drug|Magnesium Pidolate, Hydroxyurea|Intervention Description: Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months. Mg pidolate will be given at an initial dose of 0.6 mEq/kg/day divided into 2 daily doses for the first cohort of patients. This dose will be escalated for the subsequent patient cohorts as defined by a classic Phase I design (according to toxicity).
16363812|NCT00143559|Drug|Systematic chemotherapy and antibodies|"Systemic chemotherapy and antibodies as follows:
~Transplant recipients received a reduced intensity conditioning regimen consisting of OKT-3, fludarabine, thiotepa, and melphalan followed by an infusion of a T-cell depleted haploidentical hematopoietic stem cell graft. The antibody Rituximab was administered within 24 hours of the infusion in an effort to prevent PTLPD. In addition to T -cell depletion of the donor product, Mycophenylate mofetil was provided over several months as prophylaxis for GVHD"
16363813|NCT00143559|Procedure|Allogeneic stem cell transplantation|An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device
16363814|NCT00143559|Device|Miltenyi CliniMACS|Miltenyi Biotec CliniMACS stem cell selection device
16363815|NCT00143546|Drug|Defibrotide|Defibrotide to be administered approximately every 6 hours at an initial dose of 6.25 mg/kg/dose. Subsequent doses will be escalated with a plateau of 15 mg/kg/dose (or 60 mg/kg/day total). For patients with persistent VOD, the dose may be escalated by 10 mg/kg/day as needed to a maximum of 110 mg/kg/day total.
16363816|NCT00143533|Drug|Irinotecan, Cefpodoxime|See Detailed description section for treatment details.
16363817|NCT00143520|Drug|Rivoglitazone|
16363818|NCT00143520|Drug|Pioglitazone|
16363819|NCT00143520|Drug|Placebo|
16363820|NCT00143507|Drug|Ivabradine|
16363822|NCT00143494|Procedure|measurement of abdominal pressure|measurement of abdominal pressure with different volume and saline temperature
16363823|NCT00143481|Drug|Tolterodine ER 4mg QD|
16363824|NCT00143468|Behavioral|mechanical ventilation|measurement of specific lung elastance during mechanical ventilation
16363825|NCT00143455|Drug|Etoposide + cisplatin|etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
16363826|NCT00143455|Drug|Irinotecan + cisplatin|irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
16363827|NCT00143442|Drug|[S,S]-Reboxetine|
16363828|NCT00143429|Drug|Xalatan|
16363829|NCT00143416|Drug|Pegvisomant|
16363830|NCT00143403|Drug|Irinotecan + 5 FU + folinic acid|irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
16363831|NCT00143403|Drug|Folinic Acid + 5 FU|folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
16363832|NCT00143390|Drug|exemestane|take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
16363833|NCT00143390|Drug|anastrozole|take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
16363834|NCT00143377|Drug|tolterodine SR, overactive bladder|
16363835|NCT00143364|Drug|varenicline (CP-526,555)|
16363836|NCT00143351|Drug|Ziprasidone|
16363837|NCT00143338|Drug|Inhaled insulin|
16363838|NCT00143325|Drug|varenicline (CP-526,555)|
16363839|NCT00143312|Drug|voriconazole|Voriconazole is given to patients at least 48 hours after chemotherapy
16363840|NCT00143299|Drug|varenicline (CP-526,555)|
16363841|NCT00143286|Drug|varenicline (CP-526,555)|
16363842|NCT00143273|Drug|lasofoxifene|0.05 mg tablets
16363843|NCT00143273|Drug|Placebo|0 mg
16363844|NCT00143273|Drug|Lasofoxifene|0.25 mg tablets
16363845|NCT00143273|Drug|Lasofoxifene|0.5 mg tablets
16363846|NCT00143260|Drug|Viagra (Sildenafil Citrate) 100 mg|
16363847|NCT00143247|Drug|Exubera® (inhaled insulin)|Treatment of type 1 and type 2 diabetes with short-acting insulin
16363848|NCT00143234|Drug|Amlodipine/atorvastatin single pill|
16363849|NCT00143221|Drug|Viagra|
16363850|NCT00143221|Drug|Placebo|
16363851|NCT00143208|Drug|Xalacom|
16363852|NCT00143195|Drug|Amlodipine|
16363853|NCT00143195|Drug|iso- 5 - mononitrate|
16363854|NCT00143195|Procedure|Blood tests|
16363855|NCT00143195|Procedure|Exercise Stress Test|
16363856|NCT00143182|Drug|Asenapine|Asenapine , 9 weeks
16363857|NCT00143182|Drug|Olanzapine|Olanzapine, 9 weeks
16363858|NCT00143169|Drug|Parecoxib and placebo|
16363859|NCT00143156|Drug|pregabalin|
16363860|NCT00143143|Drug|Pregabalin|
16363861|NCT00143130|Drug|Pregabalin|Pregabalin
16363862|NCT00143117|Drug|UK-390,957|
16363863|NCT00143104|Drug|Inhaled insulin|
16363864|NCT00143091|Drug|CP-316,311|
16363865|NCT00143091|Drug|Placebo|
16363866|NCT00143091|Drug|Sertraline|
16363867|NCT00143065|Drug|Fludarabine|25 mg/m2/day for 5 days every 28 days (Week 2,6,10,14, 18,and 22) will be administered by IV over 10-30 minutes. (Fludarabine should be given AFTER rituximab on all days on which both drugs will be administered.)
16363868|NCT00143065|Drug|Rituximab|"Day 1, week 2 of cycle 1 rituximab 100 mg will be administered by IV, without dose escalation, over 4 hours (rate: 25 mg/hr). Day 3, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 50 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
~On Day 5, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 100 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
~Rituximab 375 mg/m2 will be repeated on Day 1 of Week 6, 10, 14, 18, and 22. During these treatments, acetaminophen and diphenhydramine prophylactic treatment is left to the discretion of the treating physician."
16363869|NCT00143065|Drug|Alemtuzumab|The dose of alemtuzumab will be escalated during Week 1 of therapy. On Day 1 of Week 1, a dose of 3 mg should be administered IV over 2-hours. If this dose is well tolerated(grade 2 or less infusion or skin related toxicity), then the dose on Day 2 can be increased to 10 mg IV over 2 hours. If this dose is well tolerated, then the dose on Day 3 will be increased to 30 mg IV over 2-hours, and if tolerated, then day 5 and all subsequent alemtuzumab doses will be 30 mg. Vital signs (blood pressure, pulse, respiration rate,temperature, and O2 saturation) and skin assessment should be assessed at baseline, 1-hour, and 1-hour post administration during week 1 and 2. Following successful escalation to 30 mg of alemtuzumab, all subsequent doses of alemtuzumab will be 30 mg administered on the second day of fludarabine therapy (week 2,6,10,14,18,and 22).
16363870|NCT00143039|Procedure|Tandem MS test for inborn errors of metabolism|Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
16363871|NCT00143026|Drug|carbidopa, levodopa, entacapone|
16363872|NCT00143000|Drug|Peginterferon alfa-2a 40KD and Ribavirin|
16363873|NCT00142987|Drug|Tegaserod|
16363874|NCT00142974|Drug|Tegaserod|
16363875|NCT00142961|Drug|Atomoxetine|atomoxetine
16363876|NCT00142961|Other|placebo|
16363877|NCT00142948|Drug|Naltrexone|naltrexone
16363878|NCT00142948|Drug|Placebo|placebo
16363879|NCT00142935|Behavioral|Pre-release Initiation of MMT|Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
16364096|NCT00141180|Drug|CP-481,715|
16364097|NCT00141167|Drug|varenicline|
16363880|NCT00142935|Behavioral|Post Release Initiation of MMT.|Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
16363881|NCT00142935|Behavioral|Standard of Care Plus|Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
16363882|NCT00142922|Behavioral|Breaking Down Barriers|completed
16363883|NCT00142909|Drug|Lofexidine|Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.
16363884|NCT00142909|Drug|Placebo|Lofexidine Placebo
16363885|NCT00142896|Drug|Tramadol|
16363886|NCT00142896|Drug|Naloxone|
16363887|NCT00142896|Drug|Morphine|
16363888|NCT00142883|Drug|Pregabalin|pregabalin compared to placebo
16363889|NCT00142883|Drug|placebo|sugar pill compared to pregabalin
16363890|NCT00142870|Drug|Bupropion|150 mg, twice a day
16363891|NCT00142844|Drug|Naltrexone|
16363892|NCT00142844|Drug|Disulfiram|
16363893|NCT00142844|Drug|Placebo|
16363894|NCT00142831|Drug|Pharmacotherapies for Smoking Cessation|Bupropion-SR or Identical Placebo
16363895|NCT00142818|Drug|Naltrexone|150 mg daily for males; 100 mg daily for females
16363896|NCT00142818|Drug|Modafinil|400 mg daily
16363897|NCT00142818|Drug|Placebo|400 mg and/or 100-150 mg placebo pills
16363898|NCT00142805|Drug|Tricaprilin|Powder formulation will be mixed in a liquid (approximately 8 oz).
16363899|NCT00142805|Other|Placebo|Powder formulation will be mixed in a liquid (approximately 8 oz).
16363900|NCT00142792|Device|NMES device with EMG-triggered and Cyclic capabilities|All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
16363901|NCT00142779|Drug|Fluoxetine|
16363902|NCT00142766|Behavioral|Nurse Implemented Goal-Directed Comfort Algorithm|See description
16363903|NCT00142753|Biological|Engerix B|Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.
16363904|NCT00142753|Biological|Twinrix for ATN 024|Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.
16363905|NCT00142753|Biological|Recombivax|Dosage at entry and week 24; non-responders ((<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.
16363906|NCT00142753|Biological|Twinrix for ATN 025|Doses at Entry and Week 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.
16363907|NCT00142727|Drug|Methadone|
16363908|NCT00142727|Drug|Full opioid agonist|
16363909|NCT00142727|Drug|Partial opioid agonist|
16363910|NCT00142727|Drug|Opioid antagonist|
16363911|NCT00142714|Procedure|Sympathetic manipulation on sexual arousal in women|
16363912|NCT00142701|Behavioral|diet|
16363913|NCT00142701|Behavioral|physical activity|
16363914|NCT00142701|Behavioral|stress management|
16363915|NCT00142701|Behavioral|smoking cessation|
16363916|NCT00142688|Behavioral|Physical activity|Tailored print-based intervention in which participants complete questionnaires and receive tailored feedback based on responses to the questionnaires. The intervention is delivered monthly during the first month, bi-monthly during months 2 and 3, and monthly during months 4-6. The intervention is completed through the mail.
16363917|NCT00142688|Behavioral|Wellness|Participants receive wellness materials delivered through the mail on the same schedule as the experimental condition. Physical activity materials are given to this group upon completion of the study.
16363918|NCT00142675|Behavioral|Physical Activity|
16363919|NCT00142662|Behavioral|diet|
16363920|NCT00142662|Behavioral|financial incentives|
16363921|NCT00142649|Behavioral|diet|
16363922|NCT00142649|Behavioral|physical activity|
16363923|NCT00142623|Behavioral|Tailored DVDs|Five DVDs aimed at reducing exposure to ETS
16363924|NCT00142610|Dietary Supplement|Vitamin|This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
16363925|NCT00142597|Device|Acupuncture|"Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.
~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.
~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
16363926|NCT00142597|Other|Sham treatment|"Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.
~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
16363927|NCT00142584|Drug|Nebivolol|Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
16363928|NCT00142584|Drug|Metoprolol|Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
16363929|NCT00142571|Drug|Gemcitabine|
16363930|NCT00142571|Drug|Docetaxel|
16363931|NCT00142558|Drug|MK0663; etoricoxib / Duration of Treatment: 5 Days|
16363932|NCT00142558|Drug|Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days|
16363933|NCT00142545|Drug|apomorphine HCl injection|
16364098|NCT00141154|Drug|Celecoxib|
16364099|NCT00141154|Drug|Placebo|
16363934|NCT00142532|Procedure|Acupuncture and Questionnaires|"Acupuncture 30 day treatment BL12 - 19 and extra point Wei Guan Xia Shu Each side of the spine,1.5 cun (~2.5cm) lateral to the lower border of spinous process of the T2 - 10 spinal vertebrae respectively 4 weeks ST36, Below the knee, 3 cun (~7.5cm) inferior to the lower border of the patella, one finger breadth lateral to the anterior crest of the tibia. One week following removal of epidural.
~Shenmen, bilaterally. At the lateral 1/3 of the triangular fossa in the auricle.One week following removal of epidural.
~Questionnaires 30 / 60 / 90 Day and 12 Month Follow-up-Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory"
16363935|NCT00142532|Procedure|Placebo Acupuncture, Questionnaires|"The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (~1.25cm) from the spine. The leg studs will be placed at 2 cun (~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (~ 5cm) proximal and 3 cun (~ 5cm) medial to the midpoint of the antecubital crease.
~Pain will be assessed by a 0 - 10 point numerical rating scale (NRS) marked no pain at one end and worst pain at the other."
16363936|NCT00142519|Drug|Methadone|Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
16363937|NCT00142519|Drug|methadone and morphine|Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg
16363938|NCT00142506|Drug|sildenafil citrate and questionaires|"Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.
~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
16363939|NCT00142506|Drug|placebo tablets and questionaires|"Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.
~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.
~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
16363940|NCT00142493|Drug|Propofol|1.2ug/ml
16363941|NCT00142493|Drug|Thiopental Sodium|2.0ug/ml
16363942|NCT00142493|Drug|Dexmedetomidine Hydrochloride|0.5ng/ml
16363943|NCT00142493|Drug|Midazolam Hydrochloride|60ng/ml
16363944|NCT00142493|Drug|placebo|intralipid, saline, saline with multi-Vit solution
16363945|NCT00142480|Drug|Capecitabine|Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).
16363946|NCT00142480|Drug|Oxaliplatin|Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
16363947|NCT00142480|Drug|Bevacizumab|Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
16363948|NCT00142480|Procedure|Radiation therapy|Once daily for 5 days (Monday through Friday) for a total of 28 treatments.
16363949|NCT00142467|Drug|Gemcitabine|
16363950|NCT00142467|Drug|Oxaliplatin|
16363951|NCT00142467|Drug|Bevacizumab|
16363952|NCT00142454|Drug|Imiquimod|Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream.
16363953|NCT00142454|Biological|NY-ESO-1 protein|NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
16363954|NCT00142441|Device|Pulsed dye laser|
16363955|NCT00142428|Drug|Cetuximab|The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.
16363956|NCT00142415|Drug|111-In-DOTA-cG250|On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
16363957|NCT00142415|Drug|177-Lu-DOTA-cG250|On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m^2 in the initial cohort.
16363958|NCT00142402|Drug|Modafinil|
16363959|NCT00142389|Biological|pneumococcal polysaccharide and protein conjugate vaccines|
16363960|NCT00142350|Drug|continuous infusion of 5-fluorouracil|
16363961|NCT00142350|Drug|combination of irinotecan and cisplatin|
16363962|NCT00142350|Drug|oral administration of S-1|
16363963|NCT00142337|Drug|Zidovudine (ZDV)|Zidovudine 300 mg, twice daily, for one month postpartum. Note: after July 03, 2005, all women received 200 mg, twice daily, for the same duration.
16363964|NCT00142337|Drug|Didanosine (ddI)|250 mg ddI-EC (400 mg if body weight >60 kg) once daily, starting at the onset of labor and for one month postpartum
16363965|NCT00142324|Drug|Donepezil|
16364100|NCT00141154|Drug|Loxoprofen|
16363966|NCT00142298|Drug|Telbivudine (LdT)|Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
16363967|NCT00142285|Drug|Zinc sulphate (20 mg)|
16363968|NCT00142272|Drug|Ciprofloxacin|
16363969|NCT00142259|Device|Deep brain stimulation of the internal globus pallidus|
16363970|NCT00142246|Drug|Intermittent preventive treatment (SP and amodiaquine)|Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.
16363971|NCT00142246|Other|Placebo|Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
16363972|NCT00142233|Dietary Supplement|ANTOX (vers.)1.2|"300 µg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day (for patients of 10 years and older)
~150 µg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine per day (for patients aged between 5 and 9 years)"
16363973|NCT00142233|Drug|Magnesium|"15 mmol per day (for patients of 10 years and older)
~7,5 mmol per day (for patients aged between 5 and 9 years)"
16363974|NCT00142233|Other|Placebo ANTOX (vers)1.2|Placebo ANTOX (vers)1.2
16363975|NCT00142233|Other|Placebo Magnesiocard (2.5 mmol)|Placebo Magnesiocard (2.5 mmol)
16363976|NCT00142220|Drug|Defined percentage of omega-3-fatty acids|
16363977|NCT00142207|Drug|Intermittent preventive treatment:sulphadoxine-pyrimethamine|Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
16363978|NCT00142207|Device|Insecticide-treated mosquito bed net|Insecticide-treated mosquito bed net
16363979|NCT00142181|Drug|Campath-1H|Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.
16363980|NCT00142168|Drug|CC-5103 (lenalidomide)|Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
16363981|NCT00142168|Drug|Rituximab|Begins on week 2 of treatment and is given intravenously once a week for 4 weeks
16363982|NCT00142155|Drug|Rituximab|
16363983|NCT00142155|Drug|monoclonal antibodies|
16363984|NCT00142129|Drug|Bortezomib (Velcade)|
16363985|NCT00142116|Drug|Thalidomide|200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
16363986|NCT00142116|Drug|Rituximab|Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
16363987|NCT00142103|Drug|CPG10101|CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks
16363988|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks
16363989|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks
16363990|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
16363991|NCT00142103|Drug|Control|Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
16363992|NCT00142103|Drug|CPG10101|CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
16363993|NCT00142090|Drug|3% Hypertonic saline|
16363994|NCT00142090|Drug|Placebo|Normal saline
16363995|NCT00142077|Device|Electronic health record and messaging system|
16363996|NCT00142064|Behavioral|observed levels of pain|
16363997|NCT00142051|Drug|nitric oxide|80 ppm 8 hrs, 40 ppm 8 hrs, 20 ppm 4 hrs, 10 ppm 4 hrs
16363998|NCT00142051|Drug|oxygen|oxygen fi02 21% (room air)
16363999|NCT00142038|Drug|Docetaxel|
16364000|NCT00142038|Drug|Capecitabine|
16364001|NCT00142025|Drug|Oxcarbazepine|
16364002|NCT00142012|Behavioral|Nutrition Intervention|
16364003|NCT00141999|Biological|hepatitis B vaccine|
16364004|NCT00141986|Dietary Supplement|vitamin D3|2000 IU per day
16364005|NCT00141986|Dietary Supplement|vitamin D3|400 IU per os once daily
16364006|NCT00141960|Drug|Famotidine|
16364007|NCT00141947|Drug|bexarotene (Targretin)|
16364008|NCT00141934|Drug|AD 452|
16364009|NCT00141921|Drug|Etanercept|Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
16364010|NCT00141908|Drug|17-alpha Hydroxyprogesterone Caproate|250 mg IM weekly
16364011|NCT00141908|Drug|Castor oil|weekly IM injections
16364012|NCT00141895|Drug|Misoprostol|2 tablets 200 micrograms Vaginal route
16364013|NCT00141895|Drug|Misoprostol|2 tablets of 200 micrograms Sublingual route
16364014|NCT00141882|Drug|memantine|
16364015|NCT00141856|Behavioral|Telephone care|
16364016|NCT00141843|Genetic|ReFacto AF|
16364017|NCT00141843|Genetic|B-Domain deleted Recombinant Factor VIII|
16364018|NCT00141843|Genetic|BDDrFVIII|
16364019|NCT00141830|Drug|Methotrexate plus ERB-041 for 12 weeks|
16364020|NCT00141830|Drug|Placebo for 12 weeks|
16364021|NCT00141817|Drug|pantoprazole for approximately 9 weeks.|
16364022|NCT00141804|Drug|Sirolimus|
16364023|NCT00141791|Drug|Etanercept|
16364024|NCT00141778|Drug|Placebo|Matching placebo taken once a day
16364025|NCT00141778|Drug|Ramipril|Taken orally, once a day
16364026|NCT00141778|Drug|Spironolactone|Taken orally, once a day
16364027|NCT00141765|Procedure|Myeloablative Chemotherapy|High dose chemotherapy (carboplatin and thiotepa) transplant rescue
16364028|NCT00141765|Procedure|Stem Cell Rescue|autologous stem cell transplantation
16364029|NCT00141752|Device|Toronto Bedside Swallowing Screening Test (TOR-BSST)|Toronto Bedside Swallowing Screening Test
16364101|NCT00141141|Drug|Atorvastatin|
16364102|NCT00141141|Drug|Simvastatin|
16364030|NCT00141739|Drug|Etanercept|"Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.
~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
16364031|NCT00141726|Drug|Etanercept|Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
16364032|NCT00141713|Drug|Etanercept|Patients enrolled on the study will receive etanercept at 0.4 mg/kg per dose up to a maximum of 25 mg per dose subcutaneously twice a week. Etanercept must be initiated within 72 hours of starting solumedrol.
16364033|NCT00141700|Drug|Rituximab|
16364034|NCT00141687|Procedure|Early ECV between 34 0/7 and 35 6/7 weeks|Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
16364035|NCT00141687|Procedure|Delayed ECV at or after 37 0/7 weeks|Delayed external cephalic version at or after 37 0/7 weeks of gestation
16364036|NCT00141674|Procedure|Blood Transfusion|This is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study.
16364037|NCT00141661|Drug|PF-04494700 - Low Dose Arm|30 mg loading dose for 6 days, followed by 10 mg daily
16364038|NCT00141661|Drug|PF-04494700 - High Dose Arm|60 mg loading dose for 6 days, followed by 20 mg daily
16364039|NCT00141661|Drug|Placebo Comparator|Matching placebo.
16364040|NCT00141648|Drug|Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.|Given intravenously on days 1,11,43: Cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, vincristine 1.4mg/m2. Given orally on days 1-5,22-27: Pednisolone 50mg/m2
16364041|NCT00141648|Radiation|Radiotherapy|Total 45 Gy in 25 fractions
16364042|NCT00141635|Behavioral|physio,pain,psychotherapy;social,nutrit.counselling&sports|
16364043|NCT00141622|Drug|Slow sodium|
16364044|NCT00141609|Drug|Slow Sodium|
16364045|NCT00141596|Drug|Cardura XL 4 mg bd|
16364046|NCT00141596|Drug|Amiloride 5 mg bd|
16364047|NCT00141596|Drug|Furosemide 40 mg bd|
16364048|NCT00141583|Drug|Enalapril 20 mg bd|
16364049|NCT00141583|Drug|Candesartan 8 mg bd|
16364050|NCT00141570|Drug|esterified estrogens 0.625 mg and methyltestosterone 1.25 mg|
16364051|NCT00141557|Drug|esterified estrogens 1.25mg and methyltestosterone 2.5mg|ESTRATEST® administered orally QD
16364052|NCT00141557|Drug|Esterified estrogens 1.25 mg|Esterified estrogens 1.25 mg administered orally QD
16364053|NCT00141544|Drug|esterified estrogens 1.25 mg and methyltestosterone 2.5 mg|ESTRATEST® administered orally QD
16364054|NCT00141544|Drug|Esterified estrogens 1.25 mg|Esterified estrogens 1.25 mg administered orally QD
16364055|NCT00141531|Drug|Apaziquone|"Apaziquone (EOquinTM) 4 mg/40 mL was administered by intravesical instillation once a week for 6 consecutive weeks.
~In addition, patients with CIS were to receive further maintenance therapy of 3 weekly apaziquone (EOquinTM) instillations at 3, 6, and 12 months from the date of histological diagnosis."
16364056|NCT00141518|Drug|Levodopa-carbidopa intestinal gel (LCIG)|
16364057|NCT00141518|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16364058|NCT00141518|Device|percutaneous endoscopic gastrostomy tube (PEG tube)|
16364059|NCT00141518|Device|jejunal extension tube (J-tube)|
16364060|NCT00141505|Drug|Bifeprunox|
16364061|NCT00141492|Drug|Androgel (testosterone gel)|
16364062|NCT00141479|Drug|Bifeprunox|
16364063|NCT00141466|Behavioral|Education for professionals|
16364064|NCT00141466|Behavioral|Distribution of educational materials|
16364065|NCT00141466|Behavioral|Feedback for professionals|
16364066|NCT00141466|Behavioral|Reminders for professionals|
16364067|NCT00141453|Drug|olmesartan medoxomil|Tablets 10, 20, or 40 mg
16364068|NCT00141453|Drug|Placebo Tablets|Matching placebo tablets
16364069|NCT00141440|Procedure|mechanical ventilation|evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease
16364070|NCT00141427|Drug|Pregabalin|
16364071|NCT00141414|Drug|Pregabalin|
16364072|NCT00141401|Drug|Pregabalin|
16364073|NCT00141388|Drug|Pregabalin|
16364074|NCT00141375|Drug|Pregabalin|
16364075|NCT00141362|Drug|Pregabalin|
16364076|NCT00141349|Drug|UK-369,003|
16364077|NCT00141336|Drug|Pregabalin|
16364078|NCT00141323|Drug|lasofoxifene|0.5 mg once per day, orally
16364079|NCT00141323|Other|placebo|placebo
16364080|NCT00141323|Drug|lasofoxifene|0.25 mg once per day, orally
16364081|NCT00141310|Drug|Sildenafil citrate|
16364082|NCT00141297|Drug|PD-0332991|Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily
16364083|NCT00141284|Drug|nelfinavir 1,250 mg twice daily|
16364084|NCT00141284|Drug|Zidovudine 300 mg twice daily|
16364085|NCT00141284|Drug|Lamivudine 150 mg twice daily|
16364086|NCT00141271|Drug|Geodon (Ziprasidone)|Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
16364087|NCT00141271|Drug|Geodon (Ziprasidone)|Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
16364088|NCT00141271|Drug|Placebo|Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
16364089|NCT00141258|Drug|pregabalin|
16364090|NCT00141245|Drug|Pregabalin|
16364091|NCT00141232|Drug|Atorvastatin and Omega-3 fatty acids|
16364092|NCT00141219|Drug|pregabalin|150-600mg/day, BID
16364093|NCT00141219|Drug|Placebo|Placebo
16364094|NCT00141206|Drug|varenicline (CP-526,555)|
16364095|NCT00141193|Drug|Celecoxib|
16364104|NCT00141115|Drug|levetiracetam|Levetiracetam 1500 mg BID
16364105|NCT00141102|Drug|Celecoxib|Participants are assigned to one of two groups in parallel for the duration of the study
16364106|NCT00141102|Drug|Diclofenac + Omeprazole|Participants are assigned to one of two groups in parallel for the duration of the study
16364107|NCT00141089|Drug|Tegaserod|
16364108|NCT00141076|Behavioral|low vs high glycemic index diet|
16364109|NCT00141063|Drug|Focalin XR|
16364110|NCT00141050|Drug|Focalin XR|
16364111|NCT00141037|Drug|Daclizumab|"Steroid-Based Immunosuppression(Prednisone) arm: 1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8 (e.g., standard dose of daclizumab induction until the second month post-transplant)
~Steroid-Free Immunosuppression (Extended daclizumab induction) arm: 2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11, and months 4, 5, and 6 (e.g., extended daclizumab induction until the sixth month post-transplant)"
16364112|NCT00141037|Drug|Mycophenolate mofetil (MMF)|Intravenous MMF was dosed at 1200 mg/m^2/day in two divided doses preoperatively and for the first 48 hours postoperatively. Oral MMF was dosed at 600 to 900 mg/m^2/day in two divided doses; the dose range allowed for dose titration according to tolerability and side effects of MMF. This regimen was used in both arms.
16364113|NCT00141037|Drug|Prednisone|Administered as 10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40 kg and 1.5 mg/kg/day in subjects weighing >40 kg. The prednisone dosing was tapered as follows: by the end of wks 1, 2, 4,6,12 and 16, dosages were 0.5, 0.4, 0.3, 0.2, 0.15 and 0.1 mg/kg/day, respectively. The prednisone dose of 0.1 mg/kg was achieved by no later than 6 months post-transplant.
16364114|NCT00141037|Drug|Tacrolimus|Taken orally from immediately preoperatively to those>age 5 yrs. (starting dose= 0.1 mg/kg/dose twice daily (BID) for living donor recipients; 0.1 mg/kg/dose daily for deceased donor recipients).Subjects <age 5 yrs. received drug from immediately preoperatively at 0.15 mg/kg/dose BID (two preoperative doses) for living donor recipients and 0.15 mg/kg/dose daily (one preoperative dose) for deceased donor recipients. Postoperatively: 0.07 mg/kg/dose BID w/adjustment to achieve target levels of 12-14 ng/mL (days 0-7), 10-12 ng/mL (wks. 2-8), 7-10 ng/mL (wks. 9-12) &5-7 ng/mL >= 12 wks. Evidence of drug toxicity on any protocol biopsy resulted in a further lowering of the drug target level to 4-6 ng/mL before yr 1 & 3-5 ng/mL after yr 1 post-transplant. This regimen was used in both arms.
16364115|NCT00141037|Drug|Ganciclovir|Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days.
16364116|NCT00141037|Drug|Valganciclovir|Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days.
16364117|NCT00141037|Drug|Trimethoprim and sulfamethoxazole|Pneumocystis pneumonia (PCP)/Urinary Tract Infection (UTI) Prophylaxis: Trimethoprim/sulfamethoxazole (Septra®) 2 mg/kg by mouth will be administered daily at bedtime for a minimum period of the first 6 months post-transplant. If unable to tolerate Septra®, inhaled pentamidine (8 mg/kg to a maximum dose of 300 mg monthly) or Dapsone (2 mg/kg PO to a maximum dose of 100 mg/day) may be substituted for a minimum of the first 6 months post-transplant. For UTI prophylaxis, if Septra® is not tolerated, nitrofurantoin (Macrodantin®), 2.5 mg/kg/day, may be given at bedtime up to a maximum dose of 100 mg/day.
16364118|NCT00141024|Biological|EP HIV-1043|"Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
~The vaccine is provided in single-use 1.1-mL vials."
16364119|NCT00141024|Biological|EP HIV-1090|DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
16364120|NCT00141011|Drug|Ancrod (Viprinex)|0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
16364121|NCT00141011|Drug|Placebo|0.6 mL/kg/hr
16364122|NCT00140998|Drug|17 beta estradiol|
16364123|NCT00140985|Drug|MK0954, losartan potassium/Duration of Treatment: 20 weeks|
16364124|NCT00140985|Drug|Comparator: amlodipine / Duration of Treatment: 20 weeks|
16364125|NCT00140972|Drug|MK0663; etoricoxib / Duration of Treatment:4 Weeks|
16364126|NCT00140972|Drug|Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks|
16364127|NCT00140959|Drug|MK0954, losartan potassium/Duration of Treatment: 18 weeks|
16364128|NCT00140959|Drug|Comparator: losartan, HCTZ, amlodipine, atenolol/Duration of Treatment: 18 weeks|
16364129|NCT00140946|Drug|MK0476; montelukast sodium/Duration of Treatment: 16 weeks|
16364130|NCT00140946|Drug|Comparator: placebo / Duration of Treatment: 16 weeks|
16364131|NCT00140933|Drug|MK0966; rofecoxib|
16364132|NCT00140933|Drug|Comparator: diclofenac, placebo|
16364133|NCT00140920|Drug|MK0966; rofecoxib|
16364134|NCT00140920|Drug|Comparator: diclofenac 2x 75 mg|
16364135|NCT00140907|Drug|losartan potassium|25 mg of oral losartan once daily, with an up-titration to 50 mg of losartan once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
16364136|NCT00140907|Drug|Comparator: Placebo|25 mg of oral placebo once daily, with an up-titration to 50 mg placebo once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
16364137|NCT00140894|Drug|MK0966; rofecoxib / Duration of Treatment: 24 weeks|
16364138|NCT00140894|Drug|Comparator: placebo / Duration of Treatment: 24 weeks|
16364139|NCT00140881|Drug|MK0476; montelukast sodium|
16364140|NCT00140881|Drug|Comparator: placebo|
16364141|NCT00140868|Device|Luminal stents|
16364142|NCT00140868|Procedure|Minimally Invasive Surgical Bowel Diversion|
16364143|NCT00140855|Biological|ipilimumab|
16364144|NCT00140816|Behavioral|Increased intake of dairy products|
16364145|NCT00140803|Drug|Visudyne|
16364146|NCT00140803|Drug|Kenalog|
16364147|NCT00140790|Drug|valsartan|valsartan 40 or 160 (80) mg per day
16364148|NCT00140764|Drug|Metronidazole gel versus placebo gel|
16364149|NCT00140751|Drug|Lopinavir/ritonavir (drug)|
16364150|NCT00140738|Biological|GSK Biologicals' 719125|Patients receive six vaccinations at two-week intervals
16364151|NCT00140725|Drug|Lamivudine plus Polyethylene glyco-interferon alfa-2b|
16364152|NCT00140725|Drug|Lamivudine|
16364153|NCT00140712|Drug|Ropinirole Immediate Release|Ropinirole Immediate Release
16364154|NCT00140699|Behavioral|Balance|
16364155|NCT00140686|Biological|Rotavirus (vaccine)|
16364156|NCT00140673|Biological|Rotavirus|
16364157|NCT00140660|Drug|rituximab|375 mg/m2 on D1
16364158|NCT00140647|Drug|Ramipril|
16364159|NCT00140647|Drug|Rosiglitazone|
16364160|NCT00140634|Biological|Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.
16364161|NCT00140621|Drug|Agalsidase beta|
16364162|NCT00140608|Device|Seprapack Sinus Dressing|
16364163|NCT00140595|Drug|rituximab|
16364164|NCT00140595|Drug|doxorubicin|
16364165|NCT00140595|Drug|cyclophosphamide|
16364166|NCT00140582|Drug|Rituximab|rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
16364167|NCT00140569|Procedure|CHVP + interferon|
16364168|NCT00140569|Drug|fludarabine|
16364169|NCT00140569|Procedure|CHOP + TBI and autotransplant|
16364170|NCT00140556|Radiation|Chemoradiotherapy|External beam radiation daily (M-F)
16364171|NCT00140556|Drug|Cisplatin|Cisplatin week 1 and 5 of radiation
16364172|NCT00140556|Drug|Bevacizumab|Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation
16364173|NCT00140556|Drug|Erlotinib|Erlotinib daily during radiation
16364174|NCT00140543|Drug|sirolimus versus mycophenolate mofetil|
16364175|NCT00140530|Device|Paclitaxel-eluting stent (Taxus)|patients has been implanted the Paclitaxel-eluting stent.
16364176|NCT00140530|Device|Rapamycin-eluting stent|patients has been implanted the Rapamycin-eluting stent.
16364177|NCT00140517|Drug|sulphadoxine-pyrimethamine|
16364178|NCT00140517|Drug|chloroquine|
16364179|NCT00140504|Other|Medcheck message|Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician
16364180|NCT00140491|Device|Vision Restoration Therapy (NOVAVISION)|
16364181|NCT00140478|Drug|Mifepristone|200mg orally once daily
16364182|NCT00140465|Drug|Clopidogrel|after PCI
16364183|NCT00140465|Drug|Clopidogrel|after PCI
16364184|NCT00140452|Drug|Thalidomide|Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.
16364185|NCT00140439|Behavioral|Emergency Department based asthma follow-up clinic|"The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains:
~Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching.
~Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings.
~Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks"
16364186|NCT00140426|Drug|Risperidone|risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
16364187|NCT00140426|Drug|Placebo|Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
16364188|NCT00140413|Drug|Nutropin AQ|Daily injection. Dosage dependent on weight.
16364189|NCT00140400|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
16364190|NCT00140387|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
16364191|NCT00140374|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
16364192|NCT00140361|Drug|Sulfadoxine-pyrimethamine|
16364193|NCT00140361|Drug|sulfadoxine-pyrimethamine plus artesunate|
16364194|NCT00140361|Drug|lumefantrine plus artemether|
16364195|NCT00140361|Behavioral|Sleeping under insecticide-treated bednet|
16364196|NCT00140348|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|
16364197|NCT00140335|Behavioral|handwashing|
16364198|NCT00140322|Behavioral|Exercise, fall risk reduction|
16364199|NCT00140309|Drug|moxifloxacin (with isoniazid, rifampin, pyrazinamide)|
16364200|NCT00140296|Behavioral|Contraceptive counseling|
16364201|NCT00140283|Procedure|Educational interactive intervention|
16364202|NCT00140270|Behavioral|PEP program|
16364203|NCT00140257|Drug|Escitalopram|
16364204|NCT00140244|Drug|r-metHuLeptin|
16364205|NCT00140244|Drug|Placebo|
16364206|NCT00140231|Drug|r-metHuLeptin|recombinant human leptin
16364207|NCT00140231|Other|placebo|placebo (no active drug)
16364208|NCT00140218|Drug|R(+) pramipexole dihydrochloride monohydrate|10 mg tid oral
16364209|NCT00140205|Drug|r-metHuLeptin|r-metreleptin was given in 3 different dose in fed and fasting states
16364210|NCT00140192|Drug|creatine|
16364211|NCT00140179|Drug|valnoctamide|
16364212|NCT00140166|Drug|niacinamide|
16364213|NCT00140166|Drug|pyridoxine|
16364214|NCT00140166|Drug|ascorbate|
16364215|NCT00140153|Drug|testosterone gel (Androgel)|
16364216|NCT00140140|Drug|ABI-007|Weekly intravenous infusions over 30 minutes.
16364217|NCT00140140|Drug|vinorelbine|Weekly intravenous infusions over 10-30 minutes, immediately after ABI-007. Vinorelbine is commercially available and was not supplied by the Sponsor.
16364218|NCT00140140|Drug|Trastuzumab|"Trastuzumab was administered to participants who had HER-2-neu positive tumors. Participants received trastuzumab by IV infusion via a vascular access device following dosing with ABI-007 and vinorelbine. During their first cycle, 4 mg/kg was administered on day 1 of that cycle as a loading dose. During subsequent weekly treatments, 2 mg/kg was administered.
~Trastuzumab is commercially available and was not supplied by the Sponsor."
16364279|NCT00139516|Drug|nicotine replacement therapy|
16364280|NCT00139516|Behavioral|smoking cessation|
16364411|NCT00138177|Drug|oxaliplatin|Given IV
16364219|NCT00140140|Biological|G-CSF|"During Part 1, participants followed a dosing regimen with ABI-007 and vinorelbine without G-CSF treatment. However, G-CSF was allowed for administration as necessary in accordance with commonly accepted clinical guidelines.
~In Part 2, participants started G-CSF treatment in concurrence with their ABI-007 and vinorelbine treatments. G-CSF was administered to all participants on Days 2-7 of each cycle, at a dose of 5 mcg/kg. If the participant's absolute neutrophil (ANC) count was >20,000/mm^3 on the day of anticipated chemotherapy, the site staff reduced the daily dose of G-CSF by 50% to 2.5 mcg/kg.
~G-CSF is commercially available and was not supplied by the Sponsor."
16364220|NCT00140114|Drug|Misoprostol (Cytotec®)|50 micrograms of sublingual or vaginal misoprostol every 4 hours for a maximum of 5 doses
16364221|NCT00140101|Device|ZoMaxx™ Drug-Eluting Coronary Stent System|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16364222|NCT00140101|Device|TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent|Drug eluting stent implantation stent in the treatment of coronary artery disease.
16364223|NCT00140088|Drug|ALGRX 3268|
16364224|NCT00140075|Drug|Epirubicin with Cyclophosphamide, followed by a Taxane|"Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2
~Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2"
16364225|NCT00140075|Drug|Epirubicin with a Taxane|"Epirubicin = 75 mg/m2 per cycle
~Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2"
16364226|NCT00140062|Drug|latanoprost 0.005% (Xalatan)|
16364227|NCT00140049|Drug|Xalacom|
16364228|NCT00140049|Drug|Cosopt|
16364229|NCT00140036|Procedure|Blood draw|
16364230|NCT00140023|Drug|Azithromycin microspheres 2.0 single dose|
16364231|NCT00140010|Drug|erythropoietin beta|30,000 units in 6 mL of 0.9% saline IV for 15 minutes every other day for 3 doses within 72 hours after aneurysmal subarachnoid hemorrhage
16364232|NCT00139997|Device|Litebook treatment devices|Litebook LED phototherapy device used for 30 min before 8 am
16364233|NCT00139997|Device|Inactivated negative ion generator|Equivalent exposure to inactivated negative ion generator
16364234|NCT00139984|Device|24 hour blood pressure measurement|
16364235|NCT00139971|Drug|gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6|
16364236|NCT00139971|Drug|UFT 250mg/m2, daily for 1 year|
16364237|NCT00139945|Drug|Human acylated ghrelin|5 pmol/kg body weight per min
16364238|NCT00139932|Drug|formoterol fumarate|
16364239|NCT00139919|Drug|Bifeprunox|
16364240|NCT00139906|Drug|Bifeprunox|
16364241|NCT00139893|Drug|Reglan ODT|
16364242|NCT00139880|Drug|Parcopa|
16364243|NCT00139867|Drug|PARCOPA|
16364244|NCT00139854|Drug|Alprazolam orally disintegrating tablets|
16364245|NCT00139841|Drug|Bendamustine HCl|Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.
16364246|NCT00139828|Drug|human coagulation Factor IX|
16364247|NCT00139815|Drug|Fondaparinux|fondaparinux 2.5 mg, s.c. injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c. injection twice daily x 2-8 days or until clinically stable
16364248|NCT00139815|Drug|enoxaparin|enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days
16364249|NCT00139802|Device|Coronary Stent Implantation|
16364250|NCT00139789|Drug|Kemstro|
16364251|NCT00139776|Drug|Celecoxib|"24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.
~Placebo used as flare medication when directed."
16364252|NCT00139776|Drug|Celecoxib|"24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.
~Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed."
16364253|NCT00139763|Procedure|Educational Materials|
16364254|NCT00139750|Drug|CP-526,555 (varenicline)|
16364255|NCT00139737|Drug|Ziprasidone|20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
16364256|NCT00139724|Drug|tolterodine extended release capsule|
16364257|NCT00139711|Drug|Irinotecan|
16364258|NCT00139711|Drug|Docetaxel|
16364259|NCT00139698|Drug|olmesartan alone or in combination with hydrochlorothiazide|
16364260|NCT00139685|Drug|Depo-Provera Contraceptive Injection - DP150CI|
16364261|NCT00139672|Drug|PD-217,014|
16364262|NCT00139659|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
16364263|NCT00139659|Drug|Subcutaneous Insulin|Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
16364264|NCT00139646|Drug|Parecoxib|
16364265|NCT00139646|Drug|Diclofenac|
16364266|NCT00139633|Drug|carboplatin, 5FU, Taxol and radiation|
16364267|NCT00139620|Drug|Tarceva, erlotinib, OSI-774|
16364268|NCT00139607|Drug|Paracoxib|
16364269|NCT00139594|Drug|licarbazepine|
16364270|NCT00139581|Drug|Pimecrolimus|Pimecrolimus cream 1 % applied twice daily (b.i.d.)
16364271|NCT00139581|Drug|Pimecrolimus|Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
16364272|NCT00139568|Drug|Tegaserod|
16364273|NCT00139555|Drug|amlodipine/benazepril|
16364274|NCT00139542|Other|One shock per minute AED protocol|Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
16364275|NCT00139542|Other|Guidelines 2000 AED protocol|Up to 3 consecutive shocks in a stack; No initial CPR prior to the first shock; Post-shock pulse checks after each non-shockable rhythm analysis; 60 sec CPR after each non-shockable rhythm analysis.
16364276|NCT00139529|Behavioral|Motivational Interviewing Telephone Counseling|Participants will receive up to 5 phone calls.
16364277|NCT00139529|Behavioral|Educational Intervention|Educational intervention will be completed during pregnancy.
16364278|NCT00139516|Behavioral|self-help|
16364281|NCT00139490|Behavioral|Health Education Program|The augmented intervention will consist of just-in-time nurse, patient and physician information and feedback during the post-acute period, plus transition to an ongoing Home-Based HTN Support Program within approximately 30 days after the patient's admission to home health care. The augmented intervention adds an HTN Nurse Specialist (advanced practice nurse) and a lay community health worker, who will be responsible for assuring a patient's smooth transition to the Home-Based HTN Support Program and for delivering the main components of that intervention, backed up by the project physician.
16364282|NCT00139490|Behavioral|Basic Group|"The basic information and referral intervention will deliver key just-in-time information to nurses, patients and patients' physicians while the patient is receiving post-acute home care services. The basic intervention relies on care provided by home health nurses during the routine home health stay."
16364283|NCT00139490|Behavioral|Control Group|Usual Care
16364284|NCT00139477|Drug|Metformin|Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated.
16364285|NCT00139477|Behavioral|Dietary modification with caloric restriction|The life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry.
16364286|NCT00139477|Behavioral|Establishment of exercise protocol|Participants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively.
16364287|NCT00139451|Drug|Pediasure|With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.
16364288|NCT00139451|Drug|GH|Growth Hormone will be 0.3mg/kg/week, given SC once daily.
16364289|NCT00139438|Behavioral|Disease Management Assessment|
16364290|NCT00139425|Behavioral|Disease Management Assessment|
16364291|NCT00139399|Procedure|Coronary artery bypass graft (CABG) surgery|Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery
16364292|NCT00139386|Drug|Candesartan|Candesartan Cilexetil (4-12 mg per day)
16364293|NCT00139373|Drug|donepezil|
16364294|NCT00139360|Drug|Bevacizumab|Anti angiogenesis treatment
16364295|NCT00139347|Biological|2-dose oral live attenuated G1P[8] human rotavirus vaccine|
16364296|NCT00139334|Biological|Rotavirus|
16364297|NCT00139321|Device|Force platform and electromyography|
16364298|NCT00139308|Device|high frequency stimulation|
16364299|NCT00139295|Device|Hylastan|
16364300|NCT00139282|Drug|Squalamine Lactate|
16364301|NCT00139269|Drug|Docetaxel|
16364302|NCT00139269|Drug|Cisplatin|
16364303|NCT00139269|Drug|5-Fluorouracil|
16364304|NCT00139256|Drug|Betamethasone|Betamethasone injection
16364305|NCT00139243|Drug|Taxotere|
16364306|NCT00139243|Drug|Cisplatin|
16364307|NCT00139243|Drug|5-Fluorouracil|
16364308|NCT00139243|Drug|Leucovorin|
16364309|NCT00139230|Drug|Taxotere|
16364310|NCT00139230|Drug|Cisplatin|
16364311|NCT00139230|Drug|5-Fluorouracil|
16364312|NCT00139230|Drug|Leucovorin|
16364313|NCT00139230|Drug|G-CSF|
16364314|NCT00139230|Drug|Ciprofloxacin|
16364315|NCT00139217|Drug|iNO|
16364316|NCT00139217|Procedure|Non-invasive nitric oxide|
16364317|NCT00139204|Procedure|C11 Methionine PET scan|
16364318|NCT00139191|Procedure|C-11 acetate PET scan|
16364319|NCT00139178|Drug|Different HAART regimens|
16364320|NCT00139165|Drug|Budesonide|Capsule. Oral 6 mg o.d. for 24 weeks
16364321|NCT00139165|Procedure|sigmoidoscopy|Sigmoidoscopy performed 2 times during the study period.
16364322|NCT00139152|Drug|Placebo|Saline, Sub-Cuteanous (SQ)
16364323|NCT00139152|Drug|Xolair|Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
16364324|NCT00139139|Biological|Hepatitis A vaccine|
16364325|NCT00139126|Behavioral|Fire safety education|Education on smoke alarm maintenance based on behavioral theories
16364326|NCT00139113|Biological|hepatitis A vaccine|2 doses of inactivated hepatitis A vaccine manufactured by GSK in licensed pediatric formulation of 720 EL. U. per dose given on 3 different schedules: aged 6 and 12 months, 12 and 18 months, and 15 and 21 months. Within each group, subjects were randomized to achieve a relatively equal number of children born to anti-HAV positive and anti-HAV negative mothers.
16364327|NCT00139100|Drug|antimicrobial agent in soap|
16364328|NCT00139087|Behavioral|Telephone Outreach for Therapy|
16364329|NCT00139074|Drug|Quetiapine fumarate|oral variable dose
16364330|NCT00139074|Drug|sodium valproate|oral
16364331|NCT00139061|Drug|Torcetrapib/Atorvastatin|
16364332|NCT00139061|Drug|Fenofibrate|
16364333|NCT00139048|Behavioral|Decision Aid|
16364334|NCT00139035|Drug|cyclosporine A|
16364335|NCT00139022|Device|Continuous Positive Airway Pressure|
16364336|NCT00139009|Drug|Cyclosporine A|
16364337|NCT00138996|Device|automated direct feedback on CPR from defibrillator|
16364338|NCT00138983|Drug|Alendronate versus alfacalcidol (1-alpha OH vitamin D)|
16364339|NCT00138970|Drug|Zenapax®, CellCept® and prednisolone|
16364340|NCT00138970|Drug|Sandimmun Neoral®, CellCept® and prednisolone|
16364341|NCT00138957|Procedure|Laparoscopic parastomal hernia repair with mesh|
16364342|NCT00138944|Drug|placebo|od
16364343|NCT00138944|Drug|eplerenone|50mg od
16364344|NCT00138931|Procedure|Blood draw (genetic testing)|Blood draw (genetic testing)
16364345|NCT00138918|Biological|OGX-011|See Detailed Description, Treatment Plan
16364346|NCT00138905|Device|UMTS mobile basestation radiation|
16364347|NCT00138892|Procedure|Waiting time (access time to Total joint replacement)|See Detailed Description.
16364348|NCT00138866|Drug|Risedronate|
16364349|NCT00138853|Device|Tibial component|Tibial component inserted at the time of surgery
16364350|NCT00138840|Drug|STA-5326 mesylate|
16364351|NCT00138827|Drug|Biotene (mouth care)|
16364352|NCT00138814|Procedure|Radiotherapy (boost versus no boost)|
16364353|NCT00138801|Drug|Ceftriaxone|
16364354|NCT00138801|Drug|Doxycycline|
16364355|NCT00138788|Procedure|Radiotherapy, dose fractionation|
16364356|NCT00138775|Drug|D-serine|
16364357|NCT00138762|Drug|torcetrapib/atorvastatin|
16364358|NCT00138762|Drug|atorvastatin|
16364359|NCT00138762|Drug|placebo|
16364360|NCT00138749|Drug|SS-RBX|
16364361|NCT00138736|Drug|Mannan Binding Lectin (MBL)|
16364362|NCT00138736|Drug|Mannan Binding Lectin|"MBL dose at a twice weekly dose interval (3 or 4 days):
~0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval"
16364363|NCT00138723|Drug|SPM 907|
16364364|NCT00138710|Drug|Letrozole (Femara)|
16364365|NCT00138697|Drug|IVIG-L|
16364366|NCT00138684|Procedure|venesection|Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
16364367|NCT00138671|Drug|Subcutaneous Insulin|Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
16364368|NCT00138671|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
16364369|NCT00138658|Drug|custirsen sodium|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days)
16364370|NCT00138645|Behavioral|MicroDiet|MicroDiet
16364371|NCT00138645|Behavioral|Healthy Diet|Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements
16364372|NCT00138632|Drug|PTK787|Visudyne® + PTK787, 500 mg/day
16364373|NCT00138632|Drug|PTK787|Visudyne® + PTK787 1000 mg/day
16364374|NCT00138632|Drug|Placebo|Visudyne® + Placebo
16364375|NCT00138619|Drug|vildagliptin|
16364376|NCT00138606|Drug|vildagliptin|
16364377|NCT00138593|Drug|vildagliptin|
16364378|NCT00138580|Drug|vildagliptin|
16364379|NCT00138567|Drug|vildagliptin|
16364380|NCT00138554|Drug|vildagliptin|
16364381|NCT00138554|Drug|pioglitazone|pioglitazone 45 mg qd
16364382|NCT00138541|Drug|vildagliptin|
16364383|NCT00138528|Drug|Fluvastatin|
16364384|NCT00138515|Drug|vildagliptin|
16364385|NCT00138476|Drug|Placebo|120 mL of the sodium bicarbonate solution, followed by 82 mL of sterile water, United States Pharmacopeia (USP) without virus; followed by 500 mg of sodium bicarbonate aqueous solution taken 5 minutes after placebo inoculation.
16364386|NCT00138476|Biological|Norwalk Virus|Prepared and packaged from liquid feces (DC544) by clarification, centrifugation, and serial dilutions; desired doses [reverse transcription polymerase chain reaction (RT-PCR) Units] 4800, 48, 4.8, 0.48.
16364387|NCT00138424|Drug|Cidofovir|Cidofovir is a marketed product for treatment of Cytomegalovirus disease (retinitis) in human immunodeficiency virus (HIV) infected patients. It is packaged as a sterile, hypertonic aqueous solution for intravenous infusion only. Dosages: 0.25 mg/kg, 0.5 mg/kg, and 1.0 mg/kg.
16364388|NCT00138424|Drug|Placebo|The control for this study is sterile, 0.9% normal saline for intravenous use.
16364389|NCT00138411|Drug|Ciprofloxacin 500 mg|
16364390|NCT00138411|Drug|ETI-204 (Anthim)|
16364391|NCT00138398|Biological|Commercial TriValent Split Influenza Virus|
16364392|NCT00138385|Biological|FluMist|
16364393|NCT00138385|Biological|Fluzone|
16364394|NCT00138359|Drug|Niclosamide|
16364395|NCT00138294|Biological|live attenuated and inactivated influenza vaccines|Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received LAIV or IIV from the local healthcare providers
16364396|NCT00138281|Biological|FluMist|
16364397|NCT00138281|Biological|Fluzone|
16364398|NCT00138242|Drug|carboplatin|
16364399|NCT00138242|Drug|docetaxel|
16364400|NCT00138242|Procedure|adjuvant therapy|
16364401|NCT00138229|Biological|aldesleukin|
16364402|NCT00138229|Biological|filgrastim|
16364403|NCT00138229|Biological|therapeutic autologous lymphocytes|
16364404|NCT00138229|Drug|cyclophosphamide|
16364405|NCT00138229|Drug|fludarabine phosphate|
16364406|NCT00138216|Drug|irinotecan hydrochloride|
16364407|NCT00138216|Drug|temozolomide|
16364408|NCT00138216|Drug|vincristine sulfate|
16364409|NCT00138203|Drug|vorinostat|Given PO
16364410|NCT00138203|Other|laboratory biomarker analysis|Correlative studies
16364412|NCT00138177|Drug|leucovorin calcium|Given IV
16364413|NCT00138177|Drug|vorinostat|Given orally
16364414|NCT00138177|Drug|fluorouracil|Given IV
16364415|NCT00138164|Biological|denileukin diftitox|
16364416|NCT00138151|Biological|recombinant interferon alpha-2b|Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
16364417|NCT00138151|Drug|isotretinoin|Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
16364418|NCT00138151|Drug|paclitaxel|Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
16364419|NCT00138138|Drug|Ritalin|
16364420|NCT00138125|Drug|Faslodex|Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.
16364421|NCT00138125|Biological|Herceptin|Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
16364422|NCT00138112|Drug|Empirical Vancomycin|
16364423|NCT00138112|Drug|Prophylactic Vancomycin|
16364424|NCT00138099|Drug|Fragmin (dalteparin sodium)|
16364425|NCT00138086|Drug|Zevalin plus BEAM|
16364426|NCT00138073|Device|Web-based waveform interpretation guide|Use of an educational website.
16364427|NCT00138060|Drug|irinotecan|180 mg/m² or 260 mg/m² in 90 minutes every 15 days
16364428|NCT00138060|Drug|5 fluorouracil|400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
16364429|NCT00138047|Drug|zinc supplementation|
16364430|NCT00138034|Procedure|Percutaneous coronary intervention (PCI)|PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
16364431|NCT00138021|Device|Computerized cognitive training program|"The cognitive training model used in the McGurk et al. (2005) study is referred to as the Thinking Skills for Work program. The program is a manualized, remediative and compensatory training intervention that is integrated with SE services. The program includes a cognitive trainer, a structured training manual (McGurk & Mueser, unpublished training manual) and a computer-based cognitive training program (described below)."
16364432|NCT00138008|Drug|endocrine therapy|Drug: endocrine therapy
16364433|NCT00138008|Procedure|radiotherapy|Procedure/Surgery: radiotherapy
16364434|NCT00137995|Drug|Rituximab|375 mg/m² D-2/D1
16364435|NCT00137995|Drug|Etoposide|100 mg/m² D1-D2-D3
16364436|NCT00137995|Drug|Carboplatine|max 800mg D2
16364437|NCT00137995|Drug|Ifosfamide + Mesna|5 g/m² from D2 to D13
16364438|NCT00137995|Drug|Cisplatine|100 mg/m² from D1 to D13
16364439|NCT00137995|Drug|Cytosine Arabinoside|2000 mg/m²/12 h D2 D3
16364440|NCT00137995|Drug|Dexamethasone|40 mg From D1 to D4
16364441|NCT00137995|Procedure|Autologous Stem Cell Transplantation|
16364442|NCT00137995|Drug|BCNU|300mg/m² on D-6
16364443|NCT00137995|Drug|Etoposide|200 mg/m² from D-6 to D-3
16364444|NCT00137995|Drug|Cytarabine|100 mg/m² from D-6 to D-3
16364445|NCT00137995|Drug|Melphalan|140 mg/m² on D-2
16364446|NCT00137982|Procedure|Treatment of ectopic pregnancy|
16364447|NCT00137969|Drug|Rituximab|Rituximab will be supplied as a sterile liquid for IV administration.
16364448|NCT00137969|Drug|Placebo|Placebo will be supplied as a sterile liquid for IV administration.
16364449|NCT00137969|Drug|Prednisone|
16364450|NCT00137969|Drug|Acetaminophen|
16364451|NCT00137969|Drug|Diphenhydramine|
16364452|NCT00137956|Device|Emphasys Endobronchial Valve (EBV) Device and Procedure|
16364453|NCT00137943|Behavioral|Full Parent communication intervention|
16364454|NCT00137943|Behavioral|Brief Parent Communication Intervention|
16364455|NCT00137943|Behavioral|Control Parent Intervention|
16364456|NCT00137930|Biological|Live attenuated rotavirus vaccine|
16364457|NCT00137917|Biological|Meningococcal serogroup B vaccine|
16364458|NCT00137891|Drug|Modified Release rhTSH|
16364459|NCT00137878|Drug|TNFerade™|
16364460|NCT00137865|Genetic|EGEN-001 (phIL-12-005/PPC)|
16364461|NCT00137852|Drug|Cisplatin|Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
16364462|NCT00137852|Drug|Irinotecan|Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
16364463|NCT00137852|Drug|Celecoxib|Given twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks.
16364464|NCT00137852|Procedure|Radiation Therapy|5 days a week for 5-6 weeks
16364465|NCT00137852|Procedure|Esophagectomy|Within 4-8 weeks of chemoradiation therapy
16364466|NCT00137839|Drug|Erlotinib|
16364467|NCT00137826|Drug|Erlotinib|Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
16364468|NCT00137826|Drug|Bevacizumab|Given intravenously over 30-90 minutes, on day 1 of each 21-day cycle. Participants may continue on study treatment until disease progresses or they experience serious side effects.
16364469|NCT00137813|Drug|Docetaxel|Given intravenously once a week for 3 out of four weeks for a minimum of 8 weeks and maximum of a year and a half
16364470|NCT00137813|Drug|Bevacizumab|Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half
16364471|NCT00137800|Drug|OSI-774 (Tarceva)|Once daily without interruption as long as there is no disease progression or serious side effects experienced.
16364472|NCT00137787|Drug|ciprofloxacin|
16364473|NCT00137787|Drug|cefepime|
16364474|NCT00137774|Drug|Bevacizumab|Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
16364475|NCT00137774|Drug|Temozolomide|Given once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects.
16364476|NCT00137761|Drug|ZD 1839|Taken orally once daily
16364477|NCT00137761|Drug|Docetaxel|Given intravenously once weekly for 2 out of 3 weeks
16364478|NCT00137748|Drug|CMV-Ig|Drug: CMV-Ig
16364479|NCT00137735|Drug|Gabapentin|300mg tds
16364480|NCT00137735|Other|placebo|tds
16364481|NCT00137722|Behavioral|Education of providers and their staff|
16364482|NCT00137722|Behavioral|Case management|
16364483|NCT00137722|Behavioral|Payment for desired behaviors|
16364484|NCT00137709|Drug|Sodium valproate|Week 1 & 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
16364485|NCT00137709|Drug|Lamotrigine|Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
16364486|NCT00137696|Biological|Vaccination with inactivated polio vaccine|
16364487|NCT00137696|Procedure|Collection of serum|
16364488|NCT00137683|Behavioral|one-on-one education, group education, small media|
16364489|NCT00137670|Device|Video-based HIV/STD prevention intervention|
16364490|NCT00137657|Drug|Cotrimoxazole (trimethoprim sulfamethoxazole)|
16364491|NCT00137644|Behavioral|Preventing AIDS Through Live Movement and Sound (PALMS)|
16364492|NCT00137631|Behavioral|Many Men, Many Voices (3MV)|Small-group, 6-session HIV prevention intervention for Black MSM.
16364493|NCT00137618|Behavioral|Educational Intervention to Increase Informed Decision Making for Prostate Cancer Screening|
16364494|NCT00137605|Biological|Pneumovax|
16364495|NCT00137605|Biological|Prevnar|
16364496|NCT00137592|Behavioral|small media, group education (multicomponent)|
16364497|NCT00137579|Procedure|Influenza vaccine intramuscular administration route|
16364498|NCT00137566|Drug|acetaminophen (paracetamol)|Paracetamol tablets, 50 mg/kg/day for 3 days.
16364499|NCT00137566|Other|Placebo|
16364500|NCT00137553|Drug|Sulfadoxine-pyrimethamine (Fansidar)|
16364501|NCT00137540|Device|RF ablation|
16364502|NCT00137540|Drug|anti-arrhythmic drug therapy|
16364503|NCT00137527|Device|Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion|
16364504|NCT00137514|Drug|chloroquine|
16364505|NCT00137514|Drug|amodiaquine|
16364506|NCT00137501|Drug|Nifedipine|"Arm A:
~Nifedipine 20 mg sublingual, repeated after 30 minutes if contractions do not decrease in intensity. Maintenance of 120-160 mgs of slow-release nifedipine daily for 48 hours.Once contractions cease, nifedipine will be maintained at 80-120 mg daily in divided doses up to 36 weeks.
~Arm B:
~Nifedipine 10 mg sublingual crushed, then 10 mg in 15 min, followed by 10 mg PO Q 15 mins PRN to a maximum of 40 mg in the first hour. Maintenance of 60-80 mgs of slow-release nifedipine daily for 48 hours. Once contractions cease, nifedipine will be maintained at 60 mg daily in divided doses up to 36 weeks."
16364507|NCT00137488|Device|imaging and angiogenic profiles|Image tumor angiogenesis by DCE-MRI using 1.5- or 3-T MRI instruments (13,14,15) pre-and postoperatively (before biopsy or surgery).
16364508|NCT00137475|Procedure|Intensity-Modulated Radiation Therapy|
16364509|NCT00137462|Drug|torcetrapib/atorvastatin|
16364510|NCT00137462|Drug|atorvastatin|
16364511|NCT00137449|Drug|SU011248|37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.
16364512|NCT00137436|Drug|Docetaxel|Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).
16364513|NCT00137436|Drug|Prednisone|Prednisone Phase1/2 - 5 mg twice a day (BID), oral.
16364514|NCT00137436|Drug|SU011248|SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).
16364515|NCT00137423|Drug|SU011248 (sunitinib)|37.5 mg/day, oral, continuous daily dosing
16364516|NCT00137410|Drug|Celebrex|
16364517|NCT00137397|Drug|Tolterodine ER|
16364518|NCT00137397|Drug|Placebo|
16364519|NCT00137371|Drug|PVC (daily for 21 days, 7 days off)|
16364520|NCT00137371|Drug|PVC (twice weekly)|
16364521|NCT00137358|Procedure|Radiation Therapy|
16364522|NCT00137358|Drug|Cisplatin|
16364523|NCT00137358|Drug|Amifostine|
16364524|NCT00137345|Drug|sirolimus|
16364525|NCT00137332|Drug|GAP-486 (ZP-123)|
16364526|NCT00137332|Drug|0.9% Sodium Chloride, USP|
16364527|NCT00137319|Device|Impedance threshold device|
16364528|NCT00137306|Procedure|Facilitate evidence-based treatment for depression|
16364529|NCT00137293|Drug|GAP-486 (ZP-123)|
16364530|NCT00137293|Drug|0.9% Sodium Chloride, USP|
16364531|NCT00137280|Behavioral|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
16364532|NCT00137267|Behavioral|Time limited case management|This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
16364533|NCT00137267|Behavioral|Health Education|This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
16364534|NCT00137254|Drug|Insulin|IV insulin
16364535|NCT00137254|Drug|Stable Isotopes|IV administration of stable isotopes
16364536|NCT00137254|Drug|Indocyanine Green|IV administration of ICG
16364537|NCT00137228|Procedure|figure-of-eight hand measurements|
16364538|NCT00137228|Procedure|water volumetry hand measurements|
16364539|NCT00137215|Device|Silverlon|dressing for donor site mamagement
16364540|NCT00137202|Drug|Ondansetron (Zofran)|
16364541|NCT00137202|Drug|Diphenhydramine (Benadryl)|
16364542|NCT00137189|Procedure|Resource-oriented music therapy|
16364543|NCT00137189|Procedure|Standard care|
16364544|NCT00137176|Drug|Rebif|Rebif 44mcg TIW
16364545|NCT00137163|Device|Dermafill Dressing|
16364546|NCT00137150|Procedure|Placement of implants|
16364547|NCT00137137|Procedure|Placement of the mini-screw|
16364548|NCT00137124|Drug|L-Arginine|oral administration of L-arginine for 4 weeks
16364549|NCT00137111|Drug|Prednisone, Dexamethasone, Vincristine, Daunorubicin|See Detailed Description sections for details on treatment interventions.
16364550|NCT00137111|Drug|Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase|See Detailed Description sections for details on treatment interventions.
16364551|NCT00137111|Drug|Methotrexate, Cyclophosphamide, Cytarabine, Etoposide|See Detailed Description sections for details on treatment interventions.
16364552|NCT00137111|Drug|Mercaptopurine, Imatinib|See Detailed Description sections for details on treatment interventions.
16364553|NCT00137111|Procedure|chemotherapy, intrathecal chemotherapy|See Detailed Description sections for details on treatment interventions.
16364554|NCT00137111|Procedure|steroid therapy, hematopoietic stem cell transplantation|See Detailed Description sections for details on treatment interventions.
16364555|NCT00137098|Drug|Caffeine|
16364556|NCT00137085|Drug|ketamine|
16364557|NCT00137072|Drug|Viagra (Sildenafil Citrate) 100 mg|
16364558|NCT00137059|Drug|acetaminophen sustained-release|
16364559|NCT00137046|Drug|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose
16364560|NCT00137046|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose
16364561|NCT00137033|Drug|Celecoxib|
16364562|NCT00137033|Drug|Naproxen|
16364563|NCT00137033|Drug|ASA|
16364564|NCT00137020|Drug|ziprasidone|
16364565|NCT00137007|Drug|Azithromycin|
16364566|NCT00137007|Drug|Ampicillin/sulbactam|
16364567|NCT00136994|Drug|Ziprasidone|
16364568|NCT00136981|Drug|torcetrapib/atorvastatin|
16364569|NCT00136981|Drug|atorvastatin|
16364570|NCT00136968|Drug|Voriconazole|
16364571|NCT00136955|Drug|Irinotecan|An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
16364572|NCT00136942|Drug|Atorvastatin|
16364573|NCT00136929|Drug|Thrombolytic therapy|
16364574|NCT00136929|Procedure|Percutaneous coronary intervention (PCI)|
16364575|NCT00136916|Drug|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose
16364576|NCT00136916|Drug|Subcutaneous insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose
16364577|NCT00136903|Drug|Prochymal - 2 million cells|2 million cells/kg actual body weight, intravenously on study Days 1 and 4
16364578|NCT00136903|Drug|Prochymal - 8 million cells|8 million cells/kg actual body weight intravenously on study Days 1 and 4
16364579|NCT00136890|Procedure|PET Imaging|Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
16364580|NCT00136877|Procedure|(adeno)tonsillectomy|
16364581|NCT00136864|Procedure|PET Diagnostic Imaging|Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy
16364582|NCT00136851|Drug|amlodipine besylate/benazepril hydrochloride|
16364583|NCT00136838|Behavioral|Neutral or active cigarette cues|Packets of cigarettes or cigarette smoke.
16364584|NCT00136825|Drug|N-Acetylcysteine|
16364585|NCT00136825|Drug|Placebo|
16364586|NCT00136812|Behavioral|stage-tailored intervention|This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge.
16364587|NCT00136799|Drug|Fluvastatin|
16364588|NCT00136786|Drug|Memantine|
16364589|NCT00136773|Drug|amlodipine/benazepril|
16364590|NCT00136760|Drug|Bupropion|Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
16364591|NCT00136760|Drug|Contingent reinforcement plus placebo|contingent reinforcement plus placebo (3 weeks)
16364592|NCT00136760|Drug|non-contingent reinforcement plus bupropion|non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
16364593|NCT00136760|Drug|Non-contingent reinforcement plus placebo|Non-contingent reinforcement plus placebo
16364594|NCT00136747|Drug|Memantine|Two capsules of Memantine twice daily for 12 days.
16364595|NCT00136747|Drug|bupropion|
16364596|NCT00136747|Drug|placebo|
16364597|NCT00136734|Drug|Methylphenidate|
16364598|NCT00136734|Other|placebo|placebo
16364599|NCT00136708|Procedure|Neonatal Resuscitation|
16364600|NCT00136695|Drug|anastrozole|1 mg QD
16364601|NCT00136682|Drug|patient-controlled epidural analgesia (PCEA)|During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
16364602|NCT00136682|Drug|patient-controlled intravenous analgesia (PCA)|During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness. While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food. This will be done once a day by a research assistant or by the research investigators.
16364603|NCT00136669|Procedure|Acupuncture|
16364604|NCT00136656|Drug|antibiotic|cephalosporine by oral route : cefixime
16364605|NCT00136656|Drug|antibiotics|cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
16364606|NCT00136643|Drug|Invisible Condom®|
16364607|NCT00136617|Drug|chlordiazepoxide|
16364608|NCT00136604|Biological|Tritanrix-HepB/Hib-MenAC|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
16371853|NCT00003413|Drug|paclitaxel|
16364609|NCT00136604|Biological|Mencevax ACWY|GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
16364610|NCT00136604|Biological|Tritanrix-HepB/Hiberix|Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
16364611|NCT00136604|Biological|Meningitec|Wyeth's MenC CRM197 conjugated vaccine, Meningitec
16364612|NCT00136591|Drug|Bortezomib|Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle
16364613|NCT00136591|Drug|Bortezomib|Arm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks.
16364614|NCT00136578|Drug|SB-715992|SB-715992 will be available either as 5 milliliter (mL) vial containing 4 milligram (mg) of SB-715992 or 4 mL vial containing 5 mg of SB-715992 at a concentration of 1 mg/mL OR a 10 mL vial that contains 10 mg of SB-715992 in a 10 mL solution at a concentration of 1 mg/mL.
16364615|NCT00136578|Drug|carboplatin|Carboplatin will be available as sterile, lyophilized white powder available in single-dose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by IV infusion. Each vial will be reconstituted with either Sterile Water for Injection, USP, 5% Dextrose in Water (D 5 W), or 0.9% Sodium Chloride Injection, USP.
16364616|NCT00136565|Drug|Velcade|1.5 mg/m², D1, D5, 4 cycles
16364617|NCT00136565|Drug|Doxorubicin|75 mg/m², D1, 4 cycles
16364618|NCT00136565|Drug|Prednisone|60 mg/m², D1-D5, 4 cycles
16364619|NCT00136565|Drug|Cyclophosphamide|1200 mg/m², D1, 4 cycles
16364620|NCT00136565|Drug|Vindesine|2 mg/m², D1, D5, 4 cycles
16364621|NCT00136565|Drug|Bleomycin|10 mg, D1, D5, 4 cycles
16364622|NCT00136552|Drug|rituximab|
16364623|NCT00136539|Drug|Herceptin|Given intravenously once weekly for 12 weeks prior to surgery.
16364624|NCT00136539|Drug|Taxol|Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
16364625|NCT00136539|Drug|Adriamycin|Given every three weeks for 12 weeks after surgery.
16364626|NCT00136539|Drug|Cytoxan|Given every three weeks for 12 weeks after surgery.
16364627|NCT00136526|Drug|Docetaxel and Diethylstilbestrol (DES)|Subjects receive docetaxel 36 Mg/m2weekly for ten cycles (3 weeks out of every 4) and DES 1 mg daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.
16364628|NCT00136513|Drug|SB-743921|
16364629|NCT00136487|Drug|Celecoxib|
16364630|NCT00136474|Drug|Amifostine|Given 30-60 minutes prior to daily radiation therapy
16364631|NCT00136474|Radiation|Radiation Therapy|Daily radiation therapy
16364632|NCT00136461|Drug|All-trans retinoic acid|
16364633|NCT00136461|Drug|Bryostatin 1|
16364634|NCT00136448|Drug|cytosine arabinoside (ara-C)|
16364635|NCT00136448|Drug|daunomycin|
16364636|NCT00136448|Drug|interleukin-2|
16364637|NCT00136435|Drug|prednisone|Induction Phase: Given orally on days 1-28
16364638|NCT00136435|Drug|doxorubicin|Induction Phaese: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle
16364639|NCT00136435|Drug|vincristine|"Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not acheived, will be given on days 29, 36 and 43.
~CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle"
16364640|NCT00136435|Drug|methotrexate|Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks
16364641|NCT00136435|Drug|asparaginase|Induction: Given into the muscle on day 5
16364642|NCT00136435|Drug|dexamethasone|Intensification: Given orally on days 1-5 of each cycle
16364643|NCT00136435|Radiation|cranial radiation|Given in 10 daily treatments during CNS therapy phase
16364644|NCT00136435|Drug|leucovorin|Induction: Given intravenously or orally 36 hours after methotrexate
16364645|NCT00136435|Drug|cytarabine|Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks
16364646|NCT00136435|Drug|hydrocortisone|Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks.
16364647|NCT00136435|Drug|6-mercaptopurine (6-MP)|CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14.
16364648|NCT00136435|Drug|e. coli L-asparaginase|Intensification: Given in to the muscle weekly.
16364649|NCT00136422|Biological|autologous tumor cells|
16364650|NCT00136409|Drug|Imatinib mesylate|400mg orally once daily until disease progression or unacceptable side effects
16364651|NCT00136396|Drug|Rituximab|Given once weekly for 4 weeks followed by a 4 week observation therapy.
16364652|NCT00136383|Drug|paroxetine versus duloxetine|
16364653|NCT00136370|Drug|Chlorhexidine|
16364654|NCT00136370|Procedure|Birth canal wipe|
16364655|NCT00136370|Procedure|sterile water external genital wipe|
16364656|NCT00136357|Behavioral|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
16364657|NCT00136344|Drug|Cefuroxime|
16364658|NCT00136344|Drug|Levofloxacin|
16364659|NCT00136331|Biological|Pandemic influenza vaccine|
16364660|NCT00136318|Drug|Escitalopram|
16364661|NCT00136318|Drug|Placebo|
16364662|NCT00136318|Drug|Peginterferon alfa-2a|Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly.
16364663|NCT00136318|Drug|Ribavirin|Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.
16364664|NCT00136305|Behavioral|Pictorial asthma action plan|
16364665|NCT00136305|Behavioral|Written asthma action plan|
16364666|NCT00136292|Drug|daptomycin|
16364667|NCT00136279|Behavioral|Linking Lives parent-based intervention|Parent intervention consists of mothers attending two, 2.5 hour-long, face-to-face sessions at the school during which they are given an intervention manual, two homework assignments, and a manual for their adolescent. Parents also receive two booster telephone calls approximately one-month and six-months after completing the intervention. As part of the comparison condition, school-based interventions for adolescents also consist of two, 2.5 hour-long, face-to-face sessions at schools during which they complete either the Project TNT intervention for preventing tobacco use or the Making a Difference intervention for reducing sexual risk behavior.
16364668|NCT00136266|Drug|Ferrous sulphate drops with vitamins A, D, and C|
16364669|NCT00136266|Drug|Ferrous fumarate sprinkles with vitamins and minerals|
16364670|NCT00136253|Behavioral|Help dietitians and patients address specific nutritional barriers|
16364671|NCT00136240|Behavioral|Computer Assisted Education for Behavior Change|
16364672|NCT00136227|Behavioral|small media intervention using video, flip chart, and pamphlets and a tailored interactive multimedia intervention|
16364673|NCT00136214|Diagnostic Test|MR brain and neuropsychiatric tests|
16364674|NCT00136201|Drug|tigecycline|
16364675|NCT00136188|Drug|Folic Acid|oral administration of folic acid 5mg /d for 4 weeks
16364676|NCT00136175|Drug|Paclitaxel|
16364677|NCT00136175|Drug|Carboplatin|
16364678|NCT00136175|Drug|Gemcitabine|
16364679|NCT00136149|Procedure|Immediate implants|Immediate implants are used.
16364680|NCT00136136|Procedure|Registration of the bispectral index and spectral edge frequency|Registration of the bispectral index and spectral edge frequency
16364681|NCT00136123|Procedure|Placement of functional loaded synthetic teeth after placement implants|Placement of functional loaded synthetic teeth after placement implants
16364682|NCT00136110|Drug|Sodium Valproate|
16364683|NCT00136097|Device|Placement of a silver impregnated central venous catheter|
16364684|NCT00136084|Drug|Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone|Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
16364685|NCT00136084|Drug|Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine|Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
16364686|NCT00136071|Device|Transobturator tape-ARIS|
16364687|NCT00136071|Device|TVT-O|
16364688|NCT00136058|Procedure|bone densitometry (DEXA)|
16364689|NCT00136058|Drug|alendronate or risedronate|
16364690|NCT00136045|Drug|Rotigotine|
16364691|NCT00136032|Drug|Somatropin|Stratified based on age and estrogen status from 3 to 6 mcg/kg/day
16364692|NCT00136032|Drug|Placebo|Dosage based on age and estrogen status ranging from 3 to 6 mcg/kg/day
16364693|NCT00136019|Drug|SPM 927|
16364694|NCT00136006|Behavioral|Study to determine the burden of disease|
16364695|NCT00135993|Drug|Rotigotine|
16364696|NCT00135980|Behavioral|professional audit and feedback|
16364697|NCT00135980|Behavioral|integrated care programmes|
16364698|NCT00135967|Drug|mycophenolate mofetil orally 1000 mg twice a day (BID)|
16364699|NCT00135967|Drug|prednisone 0,5 mg/kg orally on alternate days|
16364700|NCT00135967|Drug|intravenous (i.v.) methylprednisolone 1000 mg, total 9|
16364701|NCT00135954|Drug|Cyclophosphamide and steroids|comparison of difference in time of start of therapy
16364702|NCT00135941|Drug|insulin glargine|Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.
16364703|NCT00135941|Drug|insulin glulisine|Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.
16364704|NCT00135928|Drug|Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)|
16364705|NCT00135902|Drug|17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement|Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.
16364706|NCT00135902|Drug|17 alpha-hydroxy progesterone caproate and Placebo supplement|Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements
16364707|NCT00135889|Drug|Femoral perineural infusion|
16364708|NCT00135876|Drug|dalteparin|
16364709|NCT00135863|Drug|tinzaparin|
16364710|NCT00135850|Genetic|VEGF-A165 plasmid|
16364711|NCT00135837|Drug|Verteporfin for injection|
16364712|NCT00135824|Drug|Povidone K25 eye drops (povidone)|
16364713|NCT00135811|Drug|Cyclosporin|Participants assigned to this group will initiate treatment with CSA, 5-6 mg/kg per day with a 250 mg/day maximum starting dose, divided into two daily doses. The CSA dose will be adjusted based on drug levels determined at specified study visits in order to achieve a 12-hour trough concentration in the therapeutic range of 100-250 ng/ml.
16364714|NCT00135811|Drug|MMF and Dexamethasone|"MMF, 25-36 mg/kg per day with a maximum dose of 2 g/day divided into two daily doses. The dose range reflects the use of fixed size (250 mg) capsules and application of defined daily doses to specific weight ranges (see Table below). In younger children or those participants who are unable to swallow capsules, a liquid formulation will be used to provide 36 mg/kg per day to a maximum of 2 g per day. The starting MMF dose will be 0.5-0.67 of the full dose for 2 weeks before advancing to the full dose for the duration of the 12-month treatment period.
~Dexamethasone, 0.9 mg/kg per dose, with a maximum dose of 40 mg"
16364778|NCT00135395|Drug|Lopinavir+ritonavir|Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
16364779|NCT00135382|Drug|Videx EC|
16364780|NCT00135382|Drug|Epivir|
16364781|NCT00135382|Drug|Sustiva|
16372251|NCT00004160|Drug|cisplatin|
16364715|NCT00135798|Drug|LADR Treatment|"PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules:
~Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was <0.5 ug/kg, PEGIFN was permanently discontinued."
16364716|NCT00135785|Drug|Bupropion|
16364717|NCT00135785|Drug|Placebo|
16364718|NCT00135759|Drug|Naltrexone|low dose naltrexone in addition to daily methadone taper
16364719|NCT00135759|Drug|Placebo comparator|1 capsule/day for 6 days
16364720|NCT00135759|Drug|naltrexone|0.125 mg capsule/day for 6 days
16364721|NCT00135759|Drug|naltrexone|0.250 mg capsule/day for 6 days
16364722|NCT00135746|Drug|nicotine transdermal system|
16364723|NCT00135733|Drug|Amevive (Alefacept)|
16364724|NCT00135733|Drug|Placebo|
16364725|NCT00135720|Drug|Enbrel (Etanercept)|
16364726|NCT00135707|Drug|Dietary Supplement/Vitamins|Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.
16364727|NCT00135707|Drug|Placebo for Vitamin C and Vitamin E|Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.
16364728|NCT00135694|Drug|calcineurin inhibitor-based immunosuppression|May be cyclosporine, mycophenolate mofetil, or tacrolimus
16364729|NCT00135694|Procedure|liver transplant|Occurs at study entry
16364730|NCT00135694|Drug|corticosteroids|3-month course of corticosteroids
16364731|NCT00135694|Other|immunosuppression withdrawal|One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.
16364732|NCT00135681|Drug|nedocromil budesonide|
16364733|NCT00135668|Drug|nitroprusside|nitroprusside IV infusion 0.3-3 mcg/kg/ min
16364734|NCT00135655|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
16364735|NCT00135642|Biological|Subcutaneous Alutard SQ grass pollen (Phleum pratense)|
16364736|NCT00135642|Procedure|Venepuncture: 20 ml blood sample taken on 2 separate visits|
16364737|NCT00135629|Biological|Sublingual Alutard SQ grass pollen tablets (Phleum pratense)|
16364738|NCT00135629|Procedure|Venepuncture: 100ml blood sample taken on 12 separate visits|
16364739|NCT00135616|Device|surgical placement of a suburethral sling tvt or tvt-o|
16364740|NCT00135603|Drug|amoxicillin/clavulanate potassium|1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks
16364741|NCT00135603|Procedure|appendectomy|ablation of the appendix by laparotomy or laparoscopy
16364742|NCT00135590|Dietary Supplement|Protein pulse-feeding|Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
16364743|NCT00135590|Dietary Supplement|Spread diet|Dietary protein was spread over the four meals.
16364744|NCT00135577|Drug|alvimopan|
16364745|NCT00135577|Drug|placebo|
16364746|NCT00135564|Biological|MenC-TT|
16364747|NCT00135564|Biological|Hib-MenC-TT|
16364748|NCT00135551|Drug|Angiotensin receptor blockers|benidipine+angiotensin receptor blocker, titlation scheme
16364749|NCT00135551|Drug|β-blockers|benidipine+β-blockers, titlation scheme
16364750|NCT00135551|Drug|thiazide diuretics|benidipie+thiazide diuretics, titlation scheme
16364751|NCT00135538|Device|Noninvasive positive pressure ventilation|
16364752|NCT00135525|Drug|Paroxetine|"Fixed Dose (20 mg/day): The fixed dose of 20 mg/day was selected, because it is the recommended dose for the treatment of GAD in the US and other countries.
~Flexible Dose (20 - 40 mg/day): Overseas, the maximum dose in the treatment of GAD is 50 mg/day. However, 40 mg/day was selected as the maximum dose for this flexible dose session, because overseas clinical studies have indicated that paroxetine is sufficiently effective at doses of 20 - 40 mg/day and this is the dose range approved for depression/depressive episodes in Japan."
16364753|NCT00135525|Drug|Placebo|Placebo
16364754|NCT00135512|Drug|bupropion hydrochloride|Study drug
16364755|NCT00135499|Drug|Rituximab|375 mg/m², D1, 4 cycles
16364756|NCT00135499|Drug|Doxorubicin|75 mg/m², D1, 4 cycles
16364757|NCT00135499|Drug|Cyclophosphamide|1200 mg/m², D1, 4 cycles
16364758|NCT00135499|Drug|Vindesine|2 mg/m², D1, D5, 4 cycles
16364759|NCT00135499|Drug|Bleomycin|10 mg, D1, D5, 4 cycles
16364760|NCT00135499|Drug|Prednisone|60 mg, D1-D5, 4 cycles
16364761|NCT00135499|Drug|Prednisone|40 mg, D1-D5, 4 cycles
16364762|NCT00135499|Drug|Doxorubicin|50 mg/m², D1, 4 cycles
16364763|NCT00135499|Drug|Cyclophosphamide|750 mg/m², D1, 4 cycles
16364764|NCT00135499|Drug|Vincristine|1.4 mg/m², D1, 4 cycles
16364765|NCT00135486|Biological|MenC-TT|
16364766|NCT00135486|Biological|Hib-MenC-TT|
16364767|NCT00135473|Drug|10% Hemohes® (10% Hydroxyethyl starch)|
16364768|NCT00135473|Drug|Sterofundin® (Ringer lactate solution)|
16364769|NCT00135473|Drug|Actrapid® (Insulin)|
16364770|NCT00135460|Drug|nucleoside analogue sparing HAART regimen|
16364771|NCT00135434|Drug|Atazanavir/Ritonavir/Lopinavir/ritonavir|
16364772|NCT00135421|Drug|Pexacerfont|Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
16364773|NCT00135421|Drug|Escitalopram|Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
16364774|NCT00135421|Drug|Placebo|Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
16364775|NCT00135408|Drug|Ipilimumab+ Placebo|Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
16364776|NCT00135408|Drug|Ipilimumab+ Budesonide|Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.
16364777|NCT00135395|Drug|Atazanavir+ritonavir|Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
16364782|NCT00135369|Drug|stavudine extended-release, lamivudine, efavirenz|
16364783|NCT00135356|Drug|Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)|Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks
16364784|NCT00135356|Drug|continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)|Protease inhibitor [PI] combination + 2 NRTIs
16364785|NCT00135343|Drug|Atazanvir/ritonavir + efavirenz|Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
16364786|NCT00135343|Drug|Atazanvir/ritonavir + efavirenz|Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
16364787|NCT00135330|Drug|exenatide|subcutaneous injection, 5mcg or 10mcg, twice a day
16364788|NCT00135330|Drug|rosiglitazone|oral tablet, 2mg or 4mg, twice a day
16364789|NCT00135317|Drug|darbepoetin alfa|
16364790|NCT00135304|Drug|Sensipar®|Cinacalcet hydrochloride
16364791|NCT00135304|Drug|Vitamin D|Vitamin D administered IV
16364792|NCT00135291|Procedure|Leukoreduced blood transfusion|
16364793|NCT00135278|Procedure|CSF Drainage|See Detailed Description
16364794|NCT00135278|Procedure|No CSF Drainage|See Detailed Description
16364795|NCT00135265|Behavioral|smoking cessation, practice change|Providers will be trained in a brief smoking cessation intervention for teens.
16364796|NCT00135252|Procedure|nasal cannula oxygen delivery|
16364797|NCT00135252|Procedure|supplemental oxygen delivery by hood|
16364798|NCT00135239|Procedure|Study care|All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
16364799|NCT00135239|Procedure|Usual care|Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
16364800|NCT00135226|Drug|Aspirin|
16364801|NCT00135226|Drug|Omega-3 Ethyl Esters|
16364802|NCT00135226|Drug|Placebo Aspirin|
16364803|NCT00135226|Drug|Placebo Omega-3 Ethyl Esters|
16364804|NCT00135213|Behavioral|training in smoking cessation|
16364805|NCT00135200|Drug|Iodine I 131 Tositumomab|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 attached to Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from your body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated for you based on the scans performed following the dosimetric dose."
16364806|NCT00135187|Drug|VELCADE|"VELCADE will be used biweekly at 1.3 mg/m2 during week 1 and 2 on (days
~1, 4, 8, and 11) followed by a 1-week break."
16364807|NCT00135187|Drug|Doxil|Doxil will be administered at 30 mg/m2 IV on day 4
16364808|NCT00135187|Drug|Dexamethasone|Dexamethasone at 40 mg during the first cycle and 20 mg during cycles 2-6 po or IV daily on days of VELCADE and day after VELCADE (i.e. days 1, 2, 4, 5, 8, 9, 11, 12). The patient will be treated for six 3-week cycles followed by three 5-week maintenance cycles.
16364809|NCT00135161|Procedure|FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).|FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
16364810|NCT00135148|Procedure|Filling out a questionnaire on libido and possible partner relationship|
16364811|NCT00135148|Procedure|Sex steroid analysis|
16364812|NCT00135135|Drug|Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid|See Detailed Description.
16364813|NCT00135135|Procedure|Radiation therapy, Surgery, Peripheral Stem cell transplant|See Detailed Description.
16364814|NCT00135122|Drug|prednisolone|Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6
16364815|NCT00135109|Drug|SPM 927|
16364816|NCT00135096|Drug|insulin glulisine|PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.
16364817|NCT00135096|Drug|insulin glargine|POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.
16364818|NCT00135083|Drug|insulin glulisine|"Once Daily Insulin: Subjects will receive insulin glulisine administered once daily 0-15 minutes before the greatest glycemic impact meal of the day starting at one-tenth the total dose of insulin glargine with maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
~Twice Daily: Subjects will receive insulin glulisine administered twice daily 0-15 minutes before the 2 greatest glycemic impact meals of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
~Three Times Daily: Subjects will receive insulin glulisine administered 3 times daily 0-15 minutes before each meal of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units for each meal and additional monitoring as shown in the table below."
16364819|NCT00135070|Drug|Detemir|
16364820|NCT00135057|Drug|insulin glulisine|
16364821|NCT00135057|Drug|insulin glargine|
16364822|NCT00135044|Procedure|intravenous taurine in nutritional supplement|
16364823|NCT00135031|Drug|Bifidobacterium infantis 35624|
16364824|NCT00135018|Drug|celecoxib and chemotherapy|
16364825|NCT00135005|Drug|AMN107, STI571|
16364826|NCT00134992|Drug|Prednisolone acetate|
16364827|NCT00134979|Drug|Formoterol|
16364828|NCT00134966|Drug|capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)|
16364829|NCT00134953|Drug|Rivastigmine|
16372494|NCT00087165|Drug|docetaxel|
16364830|NCT00134914|Drug|Buprenorphine|single doses given by sublingual and parenteral routes
16364831|NCT00134901|Drug|Memantine|Memantine
16364832|NCT00134901|Drug|placebo|placebo
16364833|NCT00134888|Drug|Buprenorphine/naloxone|
16364834|NCT00134875|Drug|Buprenorphine/naloxone|Acute doses of buprenorphine/naloxone in each experimental test session. Doses delivered by either sublingual or parenteral routes, and are: 4/1, 8/2, 16/4 mg.
16364835|NCT00134836|Behavioral|Preventive Primary Care Outreach|Nurse home visit at baseline, 6 months, 12 months, including comprehensive assessment using MDS HC, care planning, referral to appropriate services
16364836|NCT00134823|Other|weight based dosing decision support|weight based dosing decision support
16364837|NCT00134810|Biological|Botulinum toxin type A|
16364838|NCT00134784|Drug|[123I]B-CIT SPECT imaging|To assess [123I]B-CIT SPECT imaging
16364839|NCT00134771|Drug|Nutrient enriched infant formula|
16364840|NCT00134758|Drug|Ursodeoxycholic acid|"During 2 years :
~between 40 and 50 kg : 500 mg/day
~between 51 and 75 kg : 750 mg/day
~between 76 and 100 kg : 1000 mg/day"
16364841|NCT00134758|Drug|Placebo|"During 2 years :
~between 40 and 50 kg : 2 tabs/day
~between 51 and 75 kg : 3 tabs/day
~between 76 and 100 kg : 4 tabs/day"
16364842|NCT00134745|Drug|estradiol|tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
16364843|NCT00134732|Biological|Live attenuated human rotavirus vaccine|
16364844|NCT00134719|Biological|MenHibrix (Hib-MenCY-TT)|One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)
16364845|NCT00134719|Biological|Infanrix® Penta|One intramuscular dose at 2, 4 and 6 months of age
16364846|NCT00134719|Biological|Prevenar®|One intramuscular dose at 2, 4 and 6 months of age
16364847|NCT00134719|Biological|ActHIB®|One intramuscular dose at 2, 4 and 6 months of age
16364848|NCT00134719|Biological|Meningitec®|One intramuscular dose at 2, 4 and 6 months of age
16364849|NCT00134719|Biological|M-M-R®II|One subcutaneous dose at 12-15 months of age
16364850|NCT00134719|Biological|Varivax®|One subcutaneous dose at 12 to 15 months of age
16364851|NCT00134719|Biological|PedvaxHIB®|One intramuscular dose at 12 to 15 months of age
16364852|NCT00134706|Drug|Docetaxel|Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
16364853|NCT00134706|Drug|Carboplatin|Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
16364854|NCT00134693|Drug|Prednisolone|
16364855|NCT00134693|Drug|SB-681323|
16364856|NCT00134680|Drug|Letrozole|Letrozole tablets 2.5 mg by mouth daily
16364857|NCT00134680|Drug|Trastuzumab|Weekly trastuzumab (4 mg/kg loading dose given by IV over 90 minutes folowed by 2 mg/kg given by IV weekly over 30 minutes, provided the previous dose was well tolerated.
16364858|NCT00134667|Drug|Photodynamic Therapy (PDT) with Visudyne (verteporfin)|
16364859|NCT00134667|Drug|Macugen (pegaptanib sodium)|
16364860|NCT00134654|Drug|Premarin|Group A: 1.25mg once a day Group B: 1.25mg three time a day Group A has been closed and participants have been given the option of enrolling in Group B. Treamtment can continue until disease progression or serious side effects.
16364861|NCT00134641|Drug|gemcitabine|
16364862|NCT00134641|Drug|vinorelbine|
16364863|NCT00134628|Procedure|Hyperbaric Oxygen Therapy|HBO at 2.0 ATA
16364864|NCT00134628|Procedure|Sham treatment|Normal air under pressure (1.1 ATA)
16364865|NCT00134615|Behavioral|RQP patient health education module|
16364866|NCT00134602|Behavioral|Needs assessment followed by tailored intervention|
16364867|NCT00134589|Behavioral|Academic Detailing (Medical Practices)+Decision Aids (Patients)|
16364868|NCT00134576|Behavioral|Computer Assisted Education for Behavioral Change|TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders.
16364869|NCT00134563|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16364870|NCT00134563|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
16364871|NCT00134550|Drug|Atorvastatin (10 mg or 80 mg)|
16364872|NCT00134537|Device|Interspinous process and dynamic stabilization|Interspinous process and dynamic stabilization
16364873|NCT00134537|Device|Conservative Care|Medication, exercise and spinal injections
16364874|NCT00134524|Procedure|MME procedure|
16364875|NCT00134511|Drug|Torcetrapib/atorvastatin|
16364876|NCT00134498|Drug|torcetrapib/atorvastatin|
16364877|NCT00134498|Drug|atorvastatin|
16364878|NCT00134485|Drug|torcetrapib/atorvastatin|
16364879|NCT00134485|Drug|atorvastatin|
16364880|NCT00134472|Procedure|Therapeutic mild hypothermia|Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
16364881|NCT00134459|Drug|Bifeprunox|
16364882|NCT00134459|Drug|Placebo|
16364883|NCT00134446|Device|transcranial magnetic stimulation|
16364884|NCT00134433|Genetic|intramyocardial VEGF angiogenesis (at a dose of 2 mg)|
16364885|NCT00134433|Drug|oral L-arginine supplementation (at a dose of 6 g/day)|
16364886|NCT00134420|Drug|Nutropin AQ|Growth Hormone (Nutropin AQ) treatment given to Group 1 immediately Growth Hormone (Nutropin AQ) treatment given to Group 2 after one year observation
16364887|NCT00134420|Procedure|Arginine and Clonidine Stimulation Testing|This testing was done to determine growth hormone status prior to starting treatment.
16364888|NCT00134420|Procedure|Growth Factors Laboratory Testing|This involved assessment of growth factors such as IGF#1 before treatment was initiated.
16364889|NCT00134420|Procedure|Neuropsychological Testing|This testing was done prior to treatment and at the end of treatment.
16364890|NCT00134407|Procedure|Normal diet|
16364891|NCT00134407|Procedure|Nutrition via jejunal needle-catheter|
16364892|NCT00134394|Drug|Etanercept plus tacrolimus|
16365200|NCT00132301|Drug|Prednisone|steroid in combination with chemotherapy agent
16364893|NCT00134381|Drug|Green Tea|Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
16364894|NCT00134381|Drug|Placebo|Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
16364895|NCT00134368|Drug|Etanercept|
16364896|NCT00134355|Drug|PTK787|
16364897|NCT00134342|Other|T-SPOT TB ELISPOT test|ELISPOT test for detecting T cell responses to tuberculosis antigens.
16364898|NCT00134329|Procedure|Filling out a questionnaire on the possible occurrence of erectile dysfunction|
16364899|NCT00134316|Behavioral|psychoeducational intervention|three 75 minute long individual psychoeducational sessions
16364900|NCT00134303|Drug|Metformin|Metformin is used.
16364901|NCT00134290|Drug|metformin|
16364902|NCT00134290|Behavioral|"standard diet advice"|
16364903|NCT00134290|Behavioral|"personal diet advice"|
16364904|NCT00134277|Procedure|Infragenual dilatation|Infragenual dilatation
16364905|NCT00134277|Procedure|Infragenual dilatation with stenting|Infragenual dilatation with stenting
16364906|NCT00134277|Procedure|Infragenual dilatation with cutting balloon|Infragenual dilatation with cutting balloon
16364907|NCT00134277|Procedure|Laser therapy|Laser therapy
16364908|NCT00134264|Drug|torcetrapib/atorvastatin|
16364909|NCT00134264|Drug|atorvastatin|
16364910|NCT00134251|Drug|SLV308|
16364911|NCT00134238|Drug|torcetrapib/atorvastatin|
16364912|NCT00134238|Drug|atorvastatin|
16364913|NCT00134225|Device|Muscle Pattern Recognition (MPR)|
16364914|NCT00134212|Drug|Dopexamine and norepinephrine|
16364915|NCT00134212|Drug|Epinephrine|
16364916|NCT00134199|Drug|CP-945,598|
16364917|NCT00134199|Drug|sibutramine|
16364918|NCT00134186|Drug|motexafin gadolinium|
16364919|NCT00134173|Drug|torcetrapib/atorvastatin|
16364920|NCT00134173|Drug|atorvastatin|
16364921|NCT00134160|Drug|Olmesartan medoxomil|Olmesartan medoxomil 40mg/Day
16364922|NCT00134160|Drug|Calcium channel blockers (amlodipine, azelnidipine)|Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
16364923|NCT00134147|Drug|Inhaled Insulin|
16364924|NCT00134134|Drug|efalizumab|
16364925|NCT00134108|Behavioral|Cognitive Behaviour Therapy|
16364926|NCT00134095|Drug|irinotecan hydrochloride|
16364927|NCT00134095|Drug|tegafur-gimeracil-oteracil potassium|
16364928|NCT00134095|Procedure|adjuvant therapy|
16364929|NCT00134095|Procedure|conventional surgery|
16364930|NCT00134095|Procedure|neoadjuvant therapy|
16364931|NCT00134082|Biological|KGEL vaccine|Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1.
16364932|NCT00134082|Biological|Filgrastim|5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.
16364933|NCT00134082|Biological|Rituximab|375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
16364934|NCT00134082|Drug|Cyclophosphamide|50 mg/kg/day on Day -3, -2, -1, and 0.
16364935|NCT00134069|Drug|sorafenib tosylate|Given orally
16364936|NCT00134069|Drug|cetuximab|Given IV
16364937|NCT00134069|Drug|irinotecan hydrochloride|Given IV
16364942|NCT00134043|Drug|vorinostat|Given orally
16364943|NCT00134030|Drug|Cisplatin|Given IV
16364944|NCT00134030|Drug|Doxorubicin Hydrochloride|Given IV
16364945|NCT00134030|Drug|Etoposide|Given IV
16364946|NCT00134030|Drug|Ifosfamide|Given IV
16364947|NCT00134030|Drug|Methotrexate|Given IV
16364948|NCT00134030|Biological|Peginterferon Alfa-2b|Given subcutaneously
16364949|NCT00134030|Other|Quality-of-Life Assessment|Ancillary studies
16364950|NCT00134030|Other|Questionnaire Administration|Ancillary studies
16364951|NCT00134030|Procedure|Therapeutic Conventional Surgery|Undergo amputation or limb salvage surgery
16364952|NCT00134017|Drug|Busulfan|Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m^2 daily (for pediatric recipients)
16364953|NCT00134017|Drug|Cyclophosphamide|Days -3, -2, +3, +4: 50 mg/kg IV daily
16364954|NCT00134004|Drug|cyclophosphamide|
16364955|NCT00134004|Drug|fludarabine phosphate|
16364956|NCT00134004|Drug|mycophenolate mofetil|
16364957|NCT00134004|Drug|tacrolimus|
16364958|NCT00134004|Procedure|allogeneic bone marrow transplantation|
16364959|NCT00134004|Radiation|radiation therapy|
16364960|NCT00133991|Biological|Filgrastim|5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.
16364961|NCT00133991|Biological|Rituximab|375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy.
16364962|NCT00133991|Drug|Cyclophosphamide|1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.
16364963|NCT00133991|Drug|Cytarabine|100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
16364964|NCT00133991|Drug|Methotrexate|3 g/m^2 on Day 8 of each cycle of R-CVP.
16364965|NCT00133991|Drug|Prednisone|100 mg on Days 1-5 of each cycle of R-CVP.
16364966|NCT00133991|Drug|Hydrocortisone|50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
16364967|NCT00133991|Drug|Vincristine|1.4 mg/m^2 on Day 1 of each cycle of R-CVP.
16364968|NCT00133991|Drug|Leucovorin|25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.
16364969|NCT00133978|Other|Glutamine|0.35 gm/kg/day parenterally and 30 gms/day enterally
16364970|NCT00133978|Other|Antioxidants|500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally
16364971|NCT00133978|Other|Glutamine + Antioxidants|0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
16364972|NCT00133978|Other|Placebo|Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
16364973|NCT00133965|Behavioral|Dignity Psychotherapy|At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires.will also receive three visits by a mental health professional over a period of five to seven days. You will be asked to fill out some brief questionnaires during this session which ask about feelings about your illness, symptoms, emotional reactions, and support you have available. The second meeting will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the Research Staff.The third meeting you will also be asked to fill out several questionnaires,including a specific questionnaire regarding your thoughts about the Dignity Psychotherapy Intervention. Total time commitment for this study should be approximately 120-150 minutes.
16364974|NCT00133965|Behavioral|Supportive Psychotherapy|you will receive the standard care you normally would receive, but will also receive three visits by a mental health professional over a period of five to seven days. The initial visit will take approximately 45 minutes. You will be asked to fill out brief questionnaires (described above) during this session.A second contact will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the research staff. During this second session, you will have the opportunity to discuss with a supportive research therapist issues or topics relevant to your experience of coping with cancer.The third and final contact,you will be asked you to fill out questionnaires similar to those you filled out at the beginning of the study. Total time commitment for this study should be approximately 120-150 minutes.
16364975|NCT00133965|Behavioral|Standard Palliative Care|"If you are in the Standard Palliative Care group you will receive the standard care that is usually provided here at Memorial Hospital. This can include services such as consultations by physicians, nurses and other healthcare professionals. In addition, referrals to community resources and services can also be made. The study period will be between five and seven days. At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires as described above. Total time commitment for this study should be approximately 60-90 minutes."
16364976|NCT00133952|Drug|Ruboxistaurin|Administered orally
16364977|NCT00133952|Drug|Placebo|Administered orally
16364978|NCT00133939|Procedure|Mechanical ventilation|
16364979|NCT00133926|Procedure|Treatment of periodontal disease|
16364980|NCT00133913|Procedure|Phlebotomy|Peripheral blood draws for testing of circulating tumor cells
16364981|NCT00133900|Procedure|Phlebotomy|Peripheral blood draws for evaluation of circulating tumor cells
16364982|NCT00133887|Drug|rapamycin|3 to 5 mg/day
16364983|NCT00133887|Drug|ciclosporine|Blood residual level < or = to 125 ng/ml
16364984|NCT00133887|Drug|tacrolimus|Blood residual level < or = to 8 ng/ml
16364985|NCT00133874|Drug|SB-275833 ointment, 1%|
16364986|NCT00133861|Drug|Botulinum toxin|
16364987|NCT00133848|Drug|SB-275833 ointment, 1%|
16364988|NCT00133835|Procedure|Extracorporeal shock wave lithotripsy|
16364989|NCT00133835|Procedure|Endoscopic drainage of the main pancreatic duct|
16364990|NCT00133822|Drug|Sertraline and Risperidone|
16364991|NCT00133809|Drug|Transplantation of Human Islets|Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure
16364992|NCT00133796|Drug|Herceptin|IV
16364993|NCT00133783|Behavioral|intermedin|
16364994|NCT00133770|Drug|pantoprazole|The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
16364995|NCT00133757|Drug|Bupropion SR|
16364996|NCT00133744|Dietary Supplement|folic acid|pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
16364997|NCT00133744|Dietary Supplement|folic acid plus iron|pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe
16364998|NCT00133744|Dietary Supplement|supplements with multiple vitamins and minerals|pills, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin(vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2mg, Iodine 150 mcg, Selenium 65 mcg
16364999|NCT00133731|Drug|Otamixaban (XRP0673)|
16365000|NCT00133731|Drug|Unfractionated Heparin|
16365001|NCT00133731|Procedure|Percutaneous Coronary Intervention|
16365002|NCT00133718|Drug|Combined lifestyle intervention and optimisation of pharmacological treatment|"6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
~standard care"
16365003|NCT00133705|Drug|Mifepristone|Mifepristone 5mg/day by mouth for 6 months
16365004|NCT00133705|Drug|Inert Capsule|sugar pill
16365005|NCT00133692|Drug|Verapamil SR/Trandolapril/Hydrochlorothiazide (HCTZ)|
16365006|NCT00133692|Drug|Atenolol/HCTZ/Trandolapril|
16365007|NCT00133679|Drug|sildenafil|Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
16365008|NCT00133679|Drug|Placebo|Placebo suspension (equal volume to experimental drug) x 45 days
16365009|NCT00133666|Behavioral|Asthma Communication Education|
16365010|NCT00133666|Behavioral|Standard Asthma Education|
16365011|NCT00133653|Behavioral|Observational|
16365012|NCT00133640|Drug|cholecalciferol|
16365013|NCT00133640|Behavioral|Physiotherapy|
16365014|NCT00133627|Drug|Ketotifen|
16365015|NCT00133614|Procedure|Prone Positioning|
16365016|NCT00133601|Behavioral|Cognitive Behavioral Therapy|CBT-I including sleep restriction, stimulus control, sleep hygiene instructions and one session of cognitive therapy devoted to catastrophic thoughts about the consequences of insomnia.
16365017|NCT00133588|Biological|Trivalent split Inf|
16365018|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^7 or 10^8 TCID50 intramuscularly (IM).
16365274|NCT00131690|Drug|Nescafé Gold Blend (exposed)|
16372495|NCT00087165|Drug|prednisone|
16365019|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^7 or 10^8 TCID50 subcutaneously (SC).
16365020|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml intradermally in the deltoid.
16365021|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml subcutaneously in the deltoid.
16365022|NCT00133575|Biological|MVA Smallpox Vaccine|MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10^6 or 10^7 TCID50 intradermally (ID).
16365023|NCT00133575|Biological|Live vaccinia virus vaccine|Dryvax® smallpox vaccine administered at approximately day 180, dosage 10^8 pfu/ml.
16365024|NCT00133575|Other|Placebo|Sterile saline (0.9%) volume of 0.5 ml intramuscularly in the deltoid.
16365025|NCT00133562|Drug|Alanyl-glutamine|
16365026|NCT00133562|Drug|Glycine|
16365027|NCT00133549|Drug|Placebo|Saline placebo administered in a volume of 0.5 ml intramuscularly.
16365028|NCT00133549|Biological|PNU-IMUNE®23|The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
16365029|NCT00133549|Biological|Nine-valent pneumococcal conjugate (PNCRM9)|Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
16365030|NCT00133536|Biological|Influenza A/H5N1 Vaccine|Monovalent inactivated subvirion influenza H5N1 vaccine (derived from A/Vietnam/1203/04). Packaged in single-dose vials of 90 mcg/mL (0.7 mL/vial). Dosage 45 mcg/0.5 mL administered intramuscularly.
16365031|NCT00133536|Drug|Placebo|Normal saline administered intramuscularly.
16365032|NCT00133523|Biological|Cold-adapted live attenuated influenza virus vaccine, trivalent|Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.
16365033|NCT00133523|Other|Placebo|Physiological saline administered as an intramuscular injection.
16365034|NCT00133523|Biological|Trivalent inactivated influenza vaccine|Inactivated influenza vaccine; single annual dose administered as an intramuscular injection..
16365035|NCT00133523|Biological|Trivalent inactivated influenza vaccine|Inactivated influenza vaccine; single annual dose administered as an intramuscular injection.
16365036|NCT00133523|Other|Placebo|Normal allantoic fluid administered annually as an internasal spray.
16365037|NCT00133510|Biological|Trivalent Subviron Influenza vaccine (Fluzone)|
16365038|NCT00133497|Biological|MF-59|Microfluoridized adjuvant 59 (MF59).
16365039|NCT00133497|Drug|Placebo|0.5 mL of saline placebo.
16365040|NCT00133497|Biological|CMV gB vaccine|CMV glycoprotein B (gB) delivered as 20 mcg in 0.5 mL of vaccine.
16365041|NCT00133484|Biological|Anthrax vaccine absorbed made from Bacillus anthracis (AVA)|
16365042|NCT00133484|Biological|Recombinant protein antigen (rPA) made from Bacillus anthrax|
16365043|NCT00133484|Biological|Recombinant protein antigen (rPA) made from Escherichia coli|
16365044|NCT00133471|Biological|Influenza A/H9N2 vaccine|A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.
16365045|NCT00133471|Drug|MF59 adjuvant|MF59 adjuvant is an oil-in-water emulsion.
16365046|NCT00133458|Drug|Albendazole|
16365047|NCT00133445|Biological|DTaP-Hep B-IPV Vaccine|U.S. licensed 13-Dec-2002. Dosage equal to 0.5 mL administered intramuscularly. Combination vaccine.
16365048|NCT00133445|Biological|Monovalent Hep B Vaccine|U.S. licensed monovalent hepatitis B vaccine; each 0.5 mL dose contains 10 mcg of hepatitis B surface antigen absorbed on 0.25 mg aluminum hydroxide. The vaccine is given to infants as a 0.5 mL dose intramuscularly.
16365049|NCT00133445|Drug|Placebo|Commercially prepared normal saline. The dose will be 0.5 mL administered intramuscularly.
16365050|NCT00133432|Drug|Zinc|
16365051|NCT00133419|Drug|Vitamin + Zinc + micronutrient mixture|
16365052|NCT00133419|Drug|Vitamin A|
16365053|NCT00133419|Drug|Vitamin A + Zinc|
16365054|NCT00133406|Drug|Glutamine|0.8gm/kg, ie up to a total daily dose of 16.2gm/day,with juice daily for 10 days
16365055|NCT00133406|Drug|Vitamin A|100,000 IU for children under 12 months of age (or placebo) and PO 200,000 IU for children at least 12 months of age (or placebo), both q months for 1 year at 0, 4 and 8 months.
16365056|NCT00133406|Drug|glycine|0.4gm/kg; ie up to 8.3gm/d, with juice daily for 10 days
16365057|NCT00133406|Drug|zinc|40 mg twice weekly for 12 months
16365058|NCT00133393|Drug|Pentoxifylline|
16365059|NCT00133380|Drug|PPAR alpha|
16365060|NCT00133380|Drug|atorvastatin|
16365061|NCT00133380|Drug|placebo|
16365062|NCT00133367|Drug|Tacrolimus|Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
16365063|NCT00133367|Drug|Sirolimus|Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
16365064|NCT00133367|Drug|G-CSF|Given starting on day 5 after transplant until the subjects white blood cell count recovers.
16365065|NCT00133367|Drug|Antithymocyte globulin|Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
16365066|NCT00133367|Drug|Thymoglobulin|Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
16365067|NCT00133367|Drug|Fludarabine|Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
16365068|NCT00133367|Drug|Melphalan|Given intravenously on day 2 before transplant.
16365069|NCT00133354|Drug|Arimidex (Anastrozole)|Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
16365133|NCT00132821|Drug|Placebo Bupropion|Days 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm)
16365070|NCT00133354|Drug|Placebo|Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
16365071|NCT00133354|Drug|Growth Hormone|GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of ~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.
16365072|NCT00133341|Drug|Goldnatriomthiosulphate, MDBGN, parthenolide|
16365073|NCT00133328|Drug|valsartan|
16365074|NCT00133315|Drug|Infliximab|
16365075|NCT00133315|Drug|Etanercept|
16365076|NCT00133315|Drug|Adalimumab|
16365077|NCT00133302|Drug|Standard CHOP|
16365078|NCT00133302|Drug|Bi-CHOP (dose intensified CHOP)|
16365079|NCT00133289|Device|Pacemaker with Automatic Capture|
16365080|NCT00133276|Drug|Escitalopram|OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks
16365081|NCT00133276|Other|Placebo|
16365082|NCT00133263|Behavioral|Primary Bereavement Care|a standardized bereavement intervention in Primary Care
16365083|NCT00133263|Behavioral|the current bereavement care in primary care|the non-standardized bereavement care that usually provided family physicians in primary care
16365084|NCT00133250|Drug|Abciximab|Abciximab bolus and infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 10 mg abciximab. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
16365085|NCT00133250|Other|Placebo Heparin Sodium|Placebo bolus plus infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 3000 U Heparin. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
16365086|NCT00133237|Device|Sirolimus-eluting stent|cypher stent is implanted due to randomization.
16365087|NCT00133237|Device|Paclitaxel-eluting stent|taxus stent is implanted due to randomization.
16365088|NCT00133224|Biological|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|Immunotherapy allogeneic GM-CSF secreting cellular vaccine
16365089|NCT00133224|Drug|Chemotherapy (docetaxel and prednisone)|Chemotherapy (docetaxel and prednisone)
16365090|NCT00133211|Procedure|Radiofrequency ablation|Pulmonary vein isolation
16365091|NCT00133198|Drug|Pramipexole|
16365092|NCT00133185|Drug|telmisartan 40 mg/hydrochlorothiazide 12.5 mg|
16365093|NCT00133185|Drug|losartan 50 mg/hydrochlorothiazide 12.5 mg|
16365094|NCT00133172|Drug|Tacrolimus|IV
16365095|NCT00133172|Drug|mycophenolate mofetil|IV
16365096|NCT00133172|Drug|Prednisone|IV
16365097|NCT00133159|Biological|Grass MATAMPL|
16365098|NCT00133146|Biological|Grass MATA MPL|
16365099|NCT00133133|Drug|ALGRX 4975|
16365100|NCT00133107|Drug|efalizumab|
16365101|NCT00133094|Drug|Simvastin|
16365102|NCT00133094|Procedure|Computer-based decision support technology|
16365103|NCT00133081|Drug|All registered antiepileptic drugs|
16365104|NCT00133068|Behavioral|Computer|Computer intervention only
16365105|NCT00133068|Behavioral|Reduction in financial barrier|Copay only
16365106|NCT00133068|Behavioral|Computer intervention & reduction of financial barrier|computer intervention & copay
16365107|NCT00133068|Behavioral|Control|No intervention
16365108|NCT00133055|Behavioral|Self-help treatment booklet and telephone support|The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.
16365109|NCT00133055|Behavioral|Usual care by a family physician|Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
16365110|NCT00133042|Drug|omalizumab|
16365111|NCT00133029|Drug|Timing of prophylactic antibiotic administration|
16365112|NCT00133016|Procedure|Amniotomy|
16365113|NCT00133003|Drug|Abciximab|0.25 mg/kg of body weight bolus, followed by a 0.125-microg/kg per minute [maximum, 10 microg/min] infusion for 12 hours, plus heparin, 70 U/kg of body weight
16365114|NCT00133003|Drug|Placebo|Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight
16365115|NCT00132990|Device|Deep brain stimulation|
16365116|NCT00132977|Device|Cardiac Resynchronization Therapy|
16365117|NCT00132964|Device|Below knee walking cast|Not required
16365118|NCT00132964|Device|Removable ankle brace|not required
16365119|NCT00132951|Drug|Telithromycin|Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)
16365120|NCT00132951|Drug|Azithromycin|Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)
16365121|NCT00132938|Drug|telithromycin|
16365122|NCT00132925|Drug|Triamcinolone|
16365123|NCT00132912|Drug|SCH 530348|
16365124|NCT00132899|Drug|Methotrexate|Methotrexate and infliximab combination
16365125|NCT00132899|Drug|Placebo|Placebo and infliximab combination therapy.
16365126|NCT00132886|Drug|tolvaptan|
16365127|NCT00132873|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution
16365128|NCT00132860|Drug|azithromycin|
16365129|NCT00132847|Biological|German Cockroach Allergen extract|
16365130|NCT00132834|Device|R-Tube or EcoScreen|Device for collection of exhaled breath condensates (EBC) collection (i.e. condensing and collecting breath vapor from a cold, solid surface)
16365131|NCT00132821|Drug|Bupropion|Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)
16365132|NCT00132821|Drug|Transdermal Nicotine Patch|21-mg nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg patch applied in AM for 2 weeks; 7-mg patch applied in AM for 1 week
16365199|NCT00132301|Drug|Docetaxel|Chemotherapy agent
16365134|NCT00132821|Drug|Placebo transdermal nicotine patch|21-mg placebo nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg placebo patch applied in AM for 2 weeks; 7-mg placebo patch applied in AM for 1 week
16365135|NCT00132808|Drug|Zoledronic Acid|Zoledronic acid 5 mg intravenous
16365136|NCT00132808|Drug|Placebo|Physiologic 0.9% normal saline
16365137|NCT00132795|Behavioral|Daily monitoring of alcohol & drug use, & therapy skills|Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).
16365138|NCT00132795|Behavioral|control group|standard care (no added treatment)
16365139|NCT00132769|Drug|MK-0873|MK-0873 1.25 mg twice daily for 12 weeks
16365140|NCT00132769|Drug|Comparator: Placebo|Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
16365141|NCT00132756|Drug|Doxil and Estramustine|
16365142|NCT00132743|Device|Stent|Stent
16365143|NCT00132743|Behavioral|Supervised Exercise Therapy|Supervised exercise therapy, three times per week
16365144|NCT00132743|Drug|Cilostazol|Cilostazol, 100 mg twice a day
16365145|NCT00132730|Drug|MK-0873 2.5 mg|
16365146|NCT00132730|Drug|MK-0873 1.25 mg|
16365147|NCT00132730|Drug|MK-0873 0.75 mg|
16365148|NCT00132730|Drug|Placebo to MK-0873|
16365149|NCT00132730|Drug|Usual Care|
16365150|NCT00132717|Drug|MK0653A (ezetimibe [+] simvastatin)|
16365151|NCT00132717|Drug|Comparator: atorvastatin|
16365152|NCT00132717|Drug|Comparator: fluvastatin|
16365153|NCT00132717|Drug|Comparator: lovastatin|
16365154|NCT00132717|Drug|Comparator: pravastatin|
16365155|NCT00132717|Drug|Comparator: rosuvastatin|
16365156|NCT00132717|Drug|Comparator: simvastatin|
16365157|NCT00132704|Radiation|Ionizing radiation (IR) therapy|Tumors will be sliced into 0.5cm fragments, incubated in culture medium and then irradiated to evaluate the kinetics and dose-dependencies of the endothelial apoptotic response. We will irradiate tumor fragments ex vivo at 0, 7, 13, 15, 17, and 25 Gy.
16365158|NCT00132704|Radiation|Ionizing radiation (IR)|Tissue fragments of a total quantity of at least a 4x4x4 cm3 will be required. For each tumor a paraffin block will also be made for routine staining and IHC. Endothelial cell populations (at least 500 cells) will then be exposed to radiation at 0, 7, 11, 13, 15, 17, and 25 Gy and harvested at 4, 5 and 8 hours post IR.
16365159|NCT00132691|Drug|fluocinolone acetonide intraocular implant|RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.
16365160|NCT00132691|Drug|oral corticosteroid with immunosuppressive agents as needed|Prednisone
16365161|NCT00132678|Drug|Risperdal Consta|12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks
16365162|NCT00132678|Drug|Placebo|Matching placebo intramuscular (IM) injection every 2 weeks
16365163|NCT00132665|Procedure|A: Radiotherapy alone|Procedure/Surgery: A: Radiotherapy alone
16365164|NCT00132665|Drug|B: CBDCA and Radiotherapy|Drug: B: CBDCA and Radiotherapy
16365165|NCT00132652|Drug|Lamivudine|
16365166|NCT00132652|Drug|Telbivudine|
16365167|NCT00132639|Drug|Preoperative docetaxel-cisplatin combination chemotherapy|Preoperative docetaxel-cisplatin combination chemotherapy
16365168|NCT00132639|Drug|Preoperative docetaxel monotherapy|Preoperative docetaxel monotherapy
16365169|NCT00132626|Drug|[123I]ß-CIT and SPECT imaging|
16365170|NCT00132613|Procedure|Observation alone after pericardial drainage|
16365171|NCT00132613|Drug|Pericardial instillation of bleomycin after drainage|
16365172|NCT00132600|Drug|bacitracin (allergen)|
16365173|NCT00132587|Device|cement Palacos R40 and LV40|
16365174|NCT00132574|Behavioral|Minimization of milk and dairy products in the diet|
16365175|NCT00132561|Drug|Sulfadoxine/pyrimethamine and artesunate|
16365176|NCT00132548|Drug|Pyrimethamine/sulfadoxine|
16365177|NCT00132548|Drug|Amodiaquine|
16365178|NCT00132548|Drug|Artesunate|
16365179|NCT00132535|Drug|sulfadoxine-pyrimethamine intermittent preventive treatment|
16365180|NCT00132535|Drug|chloroquine|
16365181|NCT00132522|Drug|EMD 273066|"dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product.
~Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2."
16365182|NCT00132509|Drug|DFIL|Alteplase : 0.8mg/kg over 90 minutes
16365183|NCT00132509|Drug|NINDS|Alteplase : 0.9mg/kg over 60 minutes
16365184|NCT00132496|Drug|rabeprazole sodium|administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
16365185|NCT00132483|Behavioral|Instruction in physical training program|Instruction in physical training program.
16365186|NCT00132470|Drug|AX200 (G-CSF)|
16365187|NCT00132457|Procedure|Self-collected vaginal swab for chlamydia testing|
16365188|NCT00132444|Drug|topical vaginal application of UC-781 gel|UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
16365189|NCT00132431|Drug|Sensipar|
16365190|NCT00132418|Drug|Enbrel|Enbrel
16365191|NCT00132418|Drug|Placebo|Placebo
16365192|NCT00132405|Drug|ALGRX 3268|
16365193|NCT00132392|Drug|ALGRX 4975|
16365194|NCT00132379|Drug|ABR-217620|10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
16365195|NCT00132379|Drug|docetaxel|75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week
16365196|NCT00132340|Device|Electrodes|
16365197|NCT00132314|Drug|IM risperidone|long-acting injectable risperidone
16365198|NCT00132314|Drug|oral antipsychotic medication|doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
16365201|NCT00132288|Behavioral|Motivational support|Participants in the PALS program at SE Seattle Senior Center are assigned a volunteer phone buddy who uses motivational interviewing techniques during bi weekly or monthly phone calls to encourage the participant to become more physically active.
16365202|NCT00132288|Behavioral|PALS - Physical activity for lifetime success|Referral by a primary care provider to a community based support program to enhance uptake or maintenance of physical activity by the participants.
16365203|NCT00132275|Drug|Amoxicillin potassium clavulanate|
16365204|NCT00132262|Behavioral|Brief intervention based on motivational interviewing|The intervention was an approximately 30 minute discussion about alcohol-related risk behaviors and motivation to change
16365205|NCT00132262|Behavioral|Standard Care including referral for treatment|Standard hospital care provided the patient with information and referral for treatment as necessary.
16365206|NCT00132236|Drug|nicotine sublingual tablets|
16365207|NCT00132236|Behavioral|low and high behavior support|
16365208|NCT00132223|Drug|Contrast agent|
16365209|NCT00132210|Drug|pegylated interferon|Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.
16365210|NCT00132197|Behavioral|Cognitive Behavioral Therapy|1. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.
16365211|NCT00132197|Procedure|Recommendation of care (letter to general practitioner [GP])|After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.
16365212|NCT00132184|Drug|Vitamin D|
16365213|NCT00132171|Drug|Sequential therapy|
16365214|NCT00132158|Drug|Irinotecan (Camptosar), Gefitinib (Iressa)|See Detailed Description for treatment plan.
16365215|NCT00132145|Behavioral|Vascular Management Program|
16365216|NCT00132145|Behavioral|Clinical Care Coordinators|
16365217|NCT00132145|Behavioral|Web-based Vascular Tracker for Patient and Physician|
16365218|NCT00132145|Behavioral|Automated Telephone Reminder System|
16365219|NCT00132132|Behavioral|Behavioral education program|Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
16365220|NCT00132119|Drug|nalmefene HCl|Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
16365221|NCT00132119|Other|Placebo|Placebo tablet
16365222|NCT00132106|Drug|phentolamine|
16365223|NCT00132093|Drug|Eplerenone|
16365224|NCT00132080|Drug|Steroids|This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
16365225|NCT00132067|Drug|vorinostat|Given orally
16365226|NCT00132054|Drug|amrubicin hydrochloride|
16365227|NCT00132054|Drug|irinotecan hydrochloride|
16365228|NCT00132041|Device|radiofrequency ablation|
16365229|NCT00132028|Drug|vorinostat|Given orally
16365230|NCT00132028|Other|laboratory biomarker analysis|Correlative studies
16365231|NCT00132015|Drug|tanespimycin|
16365232|NCT00132002|Drug|vorinostat|Given PO
16365233|NCT00132002|Other|laboratory biomarker analysis|Correlative studies
16365234|NCT00131989|Drug|sorafenib tosylate|Given orally
16365235|NCT00131989|Other|pharmacological study|Correlative studies
16365236|NCT00131989|Other|laboratory biomarker analysis|Correlative studies
16365237|NCT00131963|Drug|cyclophosphamide|Given IV
16365238|NCT00131963|Drug|doxorubicin|Given IV
16365239|NCT00131963|Drug|paclitaxel|Given IV
16365240|NCT00131950|Other|physiologic testing|
16365241|NCT00131950|Other|study of socioeconomic and demographic variables|
16365242|NCT00131950|Procedure|breast imaging study|
16365243|NCT00131950|Procedure|study of high risk factors|
16365244|NCT00131937|Drug|sorafenib tosylate|Given orally
16365245|NCT00131924|Biological|esterified estrogens|
16365246|NCT00131911|Drug|sorafenib tosylate|400 mg given orally
16365247|NCT00131898|Procedure|Surgical Resection|
16365248|NCT00131898|Procedure|Intensity Modulated Radiation Therapy (IMRT)|
16365249|NCT00131885|Dietary Supplement|Placebo Control (Placebo Herb)|Placebo herb three times daily (ground cellulose) for 4-6 weeks
16365250|NCT00131885|Dietary Supplement|St. John's Wort|St. John's Wort (Hypericum perforatum) orally or 4-6 weeks
16365251|NCT00131885|Drug|Levonorgestrel|Levonorgestrel in a single oral dose
16365252|NCT00131872|Device|Expedial Vascular Access Graft|
16365253|NCT00131859|Procedure|Diffusion-tensor imaging|Obtain a Diffusion tensor MRI of brain.
16365254|NCT00131846|Drug|Thiazide diuretics|Any dosage, frequency, and duration
16365255|NCT00131846|Drug|No diuretics|Any antihypertensive regimen other than diuretics
16365256|NCT00131833|Biological|Typhoid Vi vaccine|
16365257|NCT00131833|Biological|Meningococcal A (control)|
16365258|NCT00131820|Biological|Typhoid Vi vaccine|
16365259|NCT00131820|Biological|Hepatitis A (control)|
16365260|NCT00131807|Procedure|Blood Pressure Measurement|
16365261|NCT00131807|Procedure|Questionnaire|
16365262|NCT00131794|Biological|BCG|
16365263|NCT00131781|Behavioral|Cognitive Therapy|
16365264|NCT00131781|Behavioral|Supportive Therapy|
16365265|NCT00131768|Device|Synvisc (hylan G-F 20)|
16365266|NCT00131755|Drug|diazoxide|
16365267|NCT00131742|Drug|telbivudine|
16365268|NCT00131742|Drug|lamivudine|
16365269|NCT00131729|Behavioral|Educational programme|
16365270|NCT00131716|Drug|sulfadoxine-pyrimethamine|
16365271|NCT00131703|Drug|Amodiaquine|
16365272|NCT00131703|Drug|Sulphadoxine-pyrimethamine|
16365273|NCT00131703|Drug|Chloroquine|
16365275|NCT00131690|Drug|Nescafé Decaffeinated (controls)|
16365276|NCT00131677|Drug|tenofovir disoproxil fumarate|study product taken daily
16365277|NCT00131677|Drug|placebo|study product taken daily
16365278|NCT00131664|Drug|Avandamet|Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily compared to Avandia 4 mg and Amaryl 1 mg once daily over 6 months or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
16365279|NCT00131664|Drug|Avandia and Amaryl|Avandia 4 mg and Amaryl 1 mg once daily compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily, or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
16365280|NCT00131664|Drug|Metformin|Metformin 500 mg twice daily up to 1000 mg over 6 months compared to Avandia 4 mg and Amaryl 1 mg once daily or compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily
16365281|NCT00131651|Drug|ATN-161|
16365282|NCT00131638|Drug|Placebo|Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.
16365283|NCT00131638|Drug|Palifermin|Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course
16365284|NCT00131625|Behavioral|Health education according to WHO recommendations|
16365285|NCT00131612|Drug|FEC 100|5-fluoruracil, epirubicin and cyclophosphamide every three weeks for six treatments
16365286|NCT00131599|Drug|5FU/LV|5FU/LV
16365287|NCT00131573|Device|bion|battery powered bion microstimulator
16365288|NCT00131560|Genetic|VRX496-Modified Autologous T cells|Genetic: Anti-HIV antisense
16365289|NCT00131547|Behavioral|Dietary Counseling|Dietary Counseling, use of a food diary and pedometer
16365290|NCT00131534|Behavioral|Individual therapy|Stage-based individual therapy for trauma survivors
16365291|NCT00131534|Behavioral|Group therapy|Stage-based group therapy for trauma survivors
16365292|NCT00131521|Drug|mucomyst|
16365293|NCT00131521|Drug|sodium chloride (saline)|
16365294|NCT00131508|Drug|Glutamine|0.6 gm/kg of oral glutamine per day, in two doses for one year.
16365295|NCT00131508|Drug|Placebo|Placebo
16365296|NCT00131495|Drug|Testosterone (transdermal patches)|Testosterone patch (300mcg/day, changed twice a week for one year
16365297|NCT00131495|Drug|Placebo patch|placebo patch changed twice a week for one year
16365298|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
16365299|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
16365300|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
16365301|NCT00131482|Drug|Chrysalin|Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
16365302|NCT00131482|Drug|Placebo|Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
16365303|NCT00131469|Drug|Teriparatide (FORTEO)|Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
16365304|NCT00131469|Drug|Placebos|
16365305|NCT00131456|Drug|Venlafaxine|375mg/day
16365306|NCT00131456|Drug|Placebo|Placebo
16365307|NCT00131443|Drug|Topiramate|
16365308|NCT00131430|Drug|taranabant|
16365309|NCT00131417|Drug|ready-to-use therapeutic food|
16365310|NCT00131404|Drug|taranabant|taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
16365311|NCT00131404|Drug|Comparator: Placebo|Placebo capsule once daily. 52 week treatment period.
16365312|NCT00131391|Drug|Comparator: taranabant|taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
16365313|NCT00131391|Drug|Comparator: placebo|Placebo capsule once daily . 52 week treatment period.
16365314|NCT00131378|Drug|Nutropin AQ growth hormone|Participants will give themselves injections of growth hormone every night for 6 months.
16365315|NCT00131378|Drug|Placebo Growth Hormone|Participants will give themselves injections of placebo growth hormone every night for 6 months.
16365316|NCT00131365|Device|ExAblate 2000|
16365317|NCT00131352|Device|hylan G-F 20|Single injection of 6 mL of hylan G-F 20 (Synvisc).
16365318|NCT00131352|Other|Phosphate Buffered Saline|Single injection of 6 mL phosphate buffered saline.
16365319|NCT00131339|Behavioral|Cognitive behavioral therapy|
16365320|NCT00131339|Drug|D-cycloserine|
16365321|NCT00131326|Device|Synvisc (hylan G-F 20)|
16365322|NCT00131313|Drug|Nipent, Cytoxan, Rituxan|
16365323|NCT00131300|Device|Synvisc (hylan G-F 20)|
16365324|NCT00131287|Drug|Extract of Agaricus blazei Murill|
16365325|NCT00131274|Drug|Imatinib Mesylate (Gleevec)|
16365326|NCT00131261|Drug|PXD101|
16365327|NCT00131261|Drug|Dexamethasone|
16365328|NCT00131248|Drug|Metaclopramide|
16365329|NCT00131248|Drug|Ranitidine|
16365330|NCT00131248|Drug|placebo|
16365331|NCT00131235|Drug|Sulfadoxine-pyrimethamine treatment twice during pregnancy|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.
~2 placebo tablets for azithromycin taken at the same time points."
16365332|NCT00131235|Drug|Sulfadoxine-pyrimethamine at 4-week intervals|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
~2 placebo tablets for azithromycin taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks."
16365531|NCT00129766|Biological|motavizumab (MEDI-524)|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
16365532|NCT00129766|Biological|palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
16365669|NCT00128700|Radiation|radiation therapy|
16372573|NCT00086658|Drug|mepolizumab|
16365333|NCT00131235|Drug|Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice|"Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.
~2 azithromycin tablets (each 500 mg) taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks."
16365334|NCT00131222|Procedure|Food supplement: fortified spread|
16365335|NCT00131222|Procedure|Food supplement: maize and soy flour|
16365336|NCT00131209|Dietary Supplement|fortified spread (RUTF)|
16365337|NCT00131209|Dietary Supplement|maize and soy flour|
16365338|NCT00131183|Drug|Nebido|
16365339|NCT00131170|Procedure|paravertebral block|
16365340|NCT00131157|Procedure|expert support for interpretation of spirometry|
16365341|NCT00131144|Drug|Octreotide Acetate in Microspheres 20 mg|
16365342|NCT00131144|Drug|Octreotide Acetate in Microspheres|
16365343|NCT00131144|Drug|Placebo|
16365344|NCT00131131|Behavioral|Exercise|
16365345|NCT00131118|Drug|Zoledronic Acid|
16365346|NCT00131105|Behavioral|The Stanford Active Choices program|
16365347|NCT00131092|Behavioral|The Stanford Active Choices program|
16365348|NCT00131092|Behavioral|The TLC system|
16365349|NCT00131079|Behavioral|Experimental Programme for Physical Activity Promotion|"General practitioner's (GP) physical activity (PA) assessment and advise using a web-based software that prompted open questions to elicit believes about benefits of PA, graphical information about risks of inactivity and examples of type sentences to provide medical advise.
~Educational materials summarizing benefits, risks and motivation.
~Prescription: 15 minutes educational session in which GP negotiated a goal, addressed possible barriers and anticipated solutions using web-based tools for lack of time, community resources, and health problems. Finally, they designed a 3-month PA activity plan that derived in a standardized printed prescription of frequency, duration, intensity and progression of a selected PA or exercise that included a self-monitoring log."
16365350|NCT00131079|Behavioral|Control|Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care
16365351|NCT00131066|Other|Follow up from previous treatment with MEDI-507|There will be no investigational drugs administered under this protocol.
16365352|NCT00131053|Drug|Methotrexate|
16365353|NCT00131053|Drug|Prednisolone|
16365354|NCT00131053|Drug|Dexamethasone|
16365355|NCT00131053|Drug|Vincristine|
16365356|NCT00131053|Drug|Pirarubicin|
16365357|NCT00131053|Drug|Cyclophosphamide|
16365358|NCT00131053|Drug|L-asparaginase|
16365359|NCT00131053|Drug|Cytarabine|
16365360|NCT00131053|Drug|Hydrocortisone|
16365361|NCT00131053|Drug|Mercaptopurine|
16365362|NCT00131040|Drug|Aprotinin|
16365363|NCT00131027|Drug|Cyclophosphamide|
16365364|NCT00131027|Drug|Daunorubicin|
16365365|NCT00131027|Drug|Vincristine|
16365366|NCT00131027|Drug|Prednisolone|
16365367|NCT00131027|Drug|L-asparaginase|
16365368|NCT00131027|Drug|Cytarabine|
16365369|NCT00131027|Drug|Etoposide|
16365370|NCT00131027|Drug|Dexamethasone|
16365371|NCT00131027|Drug|Methotrexate|3 g/sqm (high dose)
16365372|NCT00131027|Drug|Mercaptopurine|
16365373|NCT00131027|Drug|Doxorubicin|
16365374|NCT00131027|Drug|Methotrexate|0.5 g/sqm (intermediate dose)
16365375|NCT00131001|Procedure|contrast-enhanced magnetic resonance angiography|
16365376|NCT00130988|Behavioral|DEPENAS cognitive and behavioural techniques|
16365377|NCT00130975|Drug|Candesartan|
16365378|NCT00130962|Drug|ALGRX 4975|
16365379|NCT00130949|Drug|ALGRX 4975|
16365380|NCT00130936|Drug|Epirubicin|
16365381|NCT00130936|Drug|Carboplatin|
16365382|NCT00130936|Drug|Capecitabine|
16365383|NCT00130923|Drug|Risperidone Long Acting|Dose 25.00, 37.50 or 50.00 mg q two weeks
16365384|NCT00130923|Drug|oral risperidone|0.50-6.00 mg oral risperidone daily
16365385|NCT00130910|Drug|Albendazole|Albendazole 400mg x 3 first dose observed
16365386|NCT00130910|Drug|Placebo|Albendazole Placebo 400mg x 3 first dose observed
16365387|NCT00130897|Drug|Sutent|Sutent, 25, 37.5. or 50 mg daily
16365388|NCT00130884|Drug|levosimendan|
16365389|NCT00130871|Drug|levosimendan|
16365390|NCT00130858|Drug|Topotecan|
16365391|NCT00130858|Drug|Carboplatin|
16365392|NCT00130845|Drug|Octreotide Acetate in Microspheres|
16365393|NCT00130845|Drug|Placebo|
16365394|NCT00130832|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
16365395|NCT00130832|Biological|Comparator: Oral Poliovirus Vaccine (OPV)|Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
16365396|NCT00130832|Biological|Comparator: Oral Poliovirus Vaccine (OPV) (staggered)|Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
16365397|NCT00130819|Behavioral|Clinic-based substance abuse treatment with buprenorphine|Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
16365398|NCT00130819|Behavioral|Case management and referred substance abuse treatment|Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence
16365399|NCT00130806|Drug|MK0478 (muraglitazar)|
16365400|NCT00130806|Drug|Comparator: placebo|
16365401|NCT00130793|Biological|Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation|1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
16365402|NCT00130793|Biological|Comparator: zoster vaccine live (Oka/Merck) frozen formulation|1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
16365610|NCT00129168|Drug|Daunorubicin|
16365611|NCT00129168|Drug|Cytarabine|
16365403|NCT00130780|Drug|Pre-surgical Treatment with Bevacizumab plus Chemotherapy|On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
16365404|NCT00130780|Drug|Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab|Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
16365405|NCT00130767|Drug|finasteride|
16365406|NCT00130754|Drug|Thymoglobuline|IV 7.5 mg/kg
16365407|NCT00130741|Drug|CHT - herbal therapy|
16365408|NCT00130728|Drug|bevacizumab|intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
16365409|NCT00130728|Drug|erlotinib HCl|oral erlotinib HCl 150 mg/day orally
16365410|NCT00130728|Drug|placebo|intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
16365411|NCT00130715|Device|Seprafilm Bioresorbable Membrane|
16365412|NCT00130702|Drug|gefitinib|gefitinib (Iressa) at a dose of 750 mg, once per day
16365413|NCT00130689|Drug|Cetuximab|
16365414|NCT00130676|Drug|Mifepristone|daily for 7 days
16365415|NCT00130676|Drug|matching placebo|daily for 7 days
16365416|NCT00130663|Device|PDA blood pressure screening program and chart reminder|
16365417|NCT00130650|Device|Pain Ease|
16365418|NCT00130637|Drug|Daclizumab|
16365419|NCT00130624|Procedure|Multidisciplinary intervention: primary or secondary care|
16365420|NCT00130611|Other|BNP measurement|
16365421|NCT00130611|Other|Clinical examination|
16365422|NCT00130598|Drug|NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)|"control group: preventive hydration with 154mEq/l saline at 1ml/kg per hour of 12 hours prior and after the procedure.
~7h-sodium bicarbonate: before contrast 3ml/kg NaHCO3 166mEq/l for one hour, followed by NaHCO3 166mEq/l (1ml/kg per hour until 6h after contrast).
~short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg) as a bolus 20 minutes before contrast; ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl non-sparkling mineral water at the start of the infusion. Ingestion of non-sparkling mineral water in the first 6 hours after contrast."
16365423|NCT00130585|Behavioral|Controlled diet|
16365424|NCT00130585|Behavioral|folic acid supplement|
16365425|NCT00130585|Behavioral|13C11-labelled folic acid supplement|
16365426|NCT00130572|Drug|Pimecrolimus|
16365427|NCT00130559|Procedure|BNP guided diagnostics and initial therapy|BNP guided diagnostics and initial therapy
16365428|NCT00130546|Device|Paclitaxel-eluting TAXUS(TM)|TAXUS(TM) Paclitaxel-eluting stent
16365429|NCT00130546|Device|Sirolimus eluting Cypher Select(TM)|Sirolimus eluting Cypher Select(TM) stent
16365430|NCT00130533|Drug|Capecitabine|
16365431|NCT00130520|Drug|bevacizumab|10mg/kg every two weeks IV-bevacizumab
16365432|NCT00130520|Drug|erlotinib|150mg daily by mouth-erlotinib
16365433|NCT00130507|Drug|Vinorelbine|
16365434|NCT00130507|Drug|Capecitabine|
16365435|NCT00130507|Drug|Trastuzumab|
16365436|NCT00130494|Drug|Zoledronic acid|
16365437|NCT00130481|Drug|Atorvastatin 20 mg daily for 3 months|
16365438|NCT00130468|Drug|Hyalgan (sodium hyaluronate)|
16365439|NCT00130455|Drug|escitalopram|
16365440|NCT00130442|Drug|PI-88 and dacarbazine|190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
16365441|NCT00130442|Drug|dacarbazine or DTIC|intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
16365442|NCT00130429|Drug|PYM50028|
16365443|NCT00130416|Behavioral|E-mail coaching to improve patient communication with doctor|
16365444|NCT00130403|Drug|risedronate sodium|
16365445|NCT00130390|Drug|Nitazoxanide|One nitazoxanide 500 mg tablet twice daily for 28 days
16365446|NCT00130390|Other|Placebo|One placebo tablet twice daily for 28 days
16365447|NCT00130377|Biological|cell therapy|autologous or allogeneic cells
16365448|NCT00130364|Drug|Pimecrolimus|Pimecrolimus 1 % cream
16365449|NCT00130364|Drug|Placebo|Pimecrolimus vehicle cream (placebo)
16365450|NCT00130351|Device|formoterol|
16365451|NCT00130338|Drug|Rivastigmine|
16365452|NCT00130325|Drug|Isoniazid|Isoniazid 900mg, tablets, twice a week for 6 months
16365453|NCT00130325|Drug|Isoniazid|INH 900mg twice weekly for 6 months
16365454|NCT00130325|Drug|Placebo of Isoniazid tablets 300mg|Isoniazid BP 0mg twice weekly for 6 months
16365455|NCT00130312|Drug|Sulodexide|100 mg gelcap in the morning and evening
16365456|NCT00130312|Drug|Placebo|1 placebo gelcap in the morning and evening
16365457|NCT00130299|Behavioral|low glycemic load diet|
16365458|NCT00130299|Behavioral|low fat diet|
16365459|NCT00130286|Drug|Rosiglitazone|4 mg tablet twice a day x 12 weeks (double-blind phase)
16365460|NCT00130286|Drug|Recombinant human growth hormone + rosiglitazone|Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
16365461|NCT00130273|Behavioral|Managed problem solving|Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
16365462|NCT00130273|Behavioral|Standard care|Participants will receive standard of care for 12 months.
16365463|NCT00130260|Biological|Staph aureus types 5 and 8 conjugate vaccine|each IM dose contains 200 mc total conjugate
16365464|NCT00130260|Biological|placebo|placebo to match StaphVAX
16365465|NCT00130247|Drug|Ethambutol|Mycobacteriostatic agent given to prevent emergence of drug resistance to other 1st line drugs; dosages are 15-25 milligram (mg)/ kilogram (kg)/day (d).
16365466|NCT00130247|Drug|Isoniazid|Hydrazide of isonicotininc acid; antimicrobial activity is limited to mycobacteria where it inhibits the synthesis of mycolic acids.
16365467|NCT00130247|Drug|Pyrazinamide|1st line bactericidal agent; dosages are 15-30 mg/kg/d, up to 2 grams (gm)/d.
16365468|NCT00130247|Drug|Rifampin|1st line bactericidal agent which inhibits deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase; dosages are 10 mg/kg/d (up to 600 mg/d).
16365469|NCT00130234|Drug|Xolair® (Omalizumab)|
16365470|NCT00130221|Drug|2% chlorhexidine gluconate impregnated cloth|
16365471|NCT00130208|Drug|Sulodexide|100 mg sulodexide gelcaps
16365472|NCT00130208|Drug|Placebo|0 mg gelcap
16365473|NCT00130195|Drug|imatinib|
16365474|NCT00130195|Drug|cyclophosphamide|
16365475|NCT00130195|Drug|daunorubicin|
16365476|NCT00130195|Drug|vincristine|
16365477|NCT00130195|Drug|prednisolone|
16365478|NCT00130195|Drug|methotrexate|
16365479|NCT00130195|Drug|cytarabine|
16365480|NCT00130195|Drug|dexamethasone|
16365481|NCT00130182|Drug|denufosol tetrasodium (INS37217)|
16365482|NCT00130169|Drug|E7974|Maximum Tolerated Dose defined as 0.35 mg/m^2 administered on Days 1 and 15 only of a 28-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
16365483|NCT00130156|Drug|Bunazosin|Patients will be randomized to the add-on treatment with Bunazosin (Detantol-R) 3 mg once-daily after breakfast for a total of eight weeks.
16365484|NCT00130156|Drug|Doxazosin|Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks.
16365485|NCT00130156|Drug|Valsartin|After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks.
16365486|NCT00130143|Drug|Ethyol (Amifostine)|
16365487|NCT00130117|Drug|r-metHuLeptin|Starting dose: 0.08mg/kg once daily Subcutaneous injection.
16365488|NCT00130117|Drug|Oral Contraceptive Pills (OCPs)|Sprintec taken orally once daily.
16365489|NCT00130117|Other|Placebo|placebo (no active medication)
16365490|NCT00130104|Procedure|Transthecal Metacarpal Block|
16365491|NCT00130091|Drug|clonidine|2 mcg clonidine added to local anesthetic
16365492|NCT00130078|Drug|1.0% C31G SAVVY vaginal gel|
16365493|NCT00130065|Drug|Sulfadoxine-pyrimethamine/folic acid|
16365494|NCT00130065|Drug|Sulfadoxine-pyrimethamine/placebo|
16365495|NCT00130039|Drug|clopidogrel|Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
16365496|NCT00130039|Drug|Cilostazol|Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
16365497|NCT00130026|Drug|Caffeine|500 mg IV
16365498|NCT00130013|Drug|Oral Amoxicillin|
16365499|NCT00130000|Drug|Eculizumab|
16365500|NCT00129987|Behavioral|Self management education|
16365501|NCT00129974|Drug|pemetrexed and gemcitabine|
16365502|NCT00129961|Drug|sirolimus|
16365503|NCT00129961|Drug|cyclosporine or tacrolimus|
16365504|NCT00129948|Drug|Troxatyl™ (troxacitabine)|
16365505|NCT00129935|Drug|Docetaxel|
16365506|NCT00129935|Drug|Capecitabine|
16365507|NCT00129935|Drug|Epirubicin|
16365508|NCT00129935|Drug|Cyclophosphamide|
16365509|NCT00129922|Drug|paclitaxel|
16365510|NCT00129922|Drug|Fluorouracil|
16365511|NCT00129922|Drug|Epirubicin|
16365512|NCT00129922|Drug|Cyclophosphamide|
16365513|NCT00129909|Drug|fixed dose combination therapy|
16365514|NCT00129896|Drug|Myocet|Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
16365515|NCT00129896|Drug|Taxotere|Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
16365516|NCT00129896|Drug|Herceptin|Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles
16365517|NCT00129883|Behavioral|Professional education|
16365518|NCT00129883|Behavioral|Implementation of a Critical Care Pathway|
16365519|NCT00129883|Behavioral|Professional audit and feedback|
16365520|NCT00129883|Behavioral|Process analysis and redesign|
16365521|NCT00129870|Drug|oxaliplatin|
16365522|NCT00129857|Drug|Dexanabinol|
16365523|NCT00129844|Drug|Motexafin Gadolinium|
16365524|NCT00129831|Drug|QAB149|
16365525|NCT00129818|Drug|Famciclovir|
16365526|NCT00129805|Drug|MCI-9042|
16365527|NCT00129805|Drug|Aspirin|
16365528|NCT00129792|Drug|Dietary supplement for weight loss|The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
16365529|NCT00129792|Behavioral|Education and counseling for weight loss|Hour and a half weight loss education session weekly for 12 weeks.
16365530|NCT00129779|Behavioral|Intermediate care package|
16365612|NCT00129155|Drug|treosulfan|
16365533|NCT00129753|Drug|Alemtuzumab (Campath-1H)|Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
16365534|NCT00129740|Drug|Nilotinib|400 mg orally twice daily
16365535|NCT00129727|Drug|Paclitaxel|Given intravenously
16365536|NCT00129727|Drug|Carboplatin|Given intravenously
16365537|NCT00129727|Drug|Bevacizumab|Given intravenously
16365538|NCT00129714|Other|cervical collar|
16365539|NCT00129714|Other|physiotherapy|
16365540|NCT00129701|Procedure|Telephone consultation|
16365541|NCT00129688|Drug|cloxacillin and amikacin (once or twice daily dosage)|
16365542|NCT00129675|Drug|[123I]ß CIT|"Single Photon Emission Computed Tomography
~SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI."
16365543|NCT00129662|Behavioral|Pictorial action plan|
16365544|NCT00129649|Behavioral|Telephone reminder call|
16365545|NCT00129636|Procedure|Additional specific letter written to patient|
16365546|NCT00129623|Drug|Placebo|po monthly for 1 year
16365547|NCT00129623|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 1 year
16365548|NCT00129610|Behavioral|Virtual Reality Therapy|
16365549|NCT00129610|Behavioral|Cognitive Behavior Therapy|
16365550|NCT00129597|Drug|ketalar|
16365551|NCT00129584|Procedure|Emphasys Endobronchial Valve and procedure|
16365552|NCT00129571|Drug|XL820|
16365553|NCT00129558|Drug|PT-523 for Injection|
16365554|NCT00129545|Device|WATCHMAN Left Atrial Appendage Closure Technology|Implant of WATCHMAN Left Atrial Appendage Closure Technology
16365555|NCT00129545|Drug|Warfarin|Subjects receive warfarin
16365556|NCT00129532|Drug|1.0% C31G SAVVY vaginal gel|
16365557|NCT00129519|Drug|Imiquimod 5% cream|Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
16365558|NCT00129506|Drug|methotrexate + misoprostol|
16365559|NCT00129506|Drug|misoprostol|
16365560|NCT00129493|Behavioral|Group medical visits|Our intervention aims to develop and implement a model of group medical visits in iterative steps, to evaluate whether group medical visits improve patient adherence to prescribed antihypertensive medications and improve BP control, and to assess patient, physician, and health care system factors involved in successfully making organizational changes to encompass group medical visits.
16365561|NCT00129480|Behavioral|Assistance with Pain treatment|Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
16365562|NCT00129467|Drug|Methylphenidate|"Subjects will take methylphenidate 5 mg twice daily (bid) for 3 days, then 10 mg bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of methylphenidate, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%. During the 18-day blinded treatment period the total daily dose will not exceed 20 mg.
~If subjects have side effects when increasing to 10 mg bid, they will drop back to 5 mg bid. If the participant develops psychosis or cardiac events, they will be discontinued from methylphenidate.
~Subjects who receive methylphenidate and respond with a 50% reduction in MADRS score will have the option to continue in the open label portion of the study for up to 6 weeks. For patients taking methylphenidate 10 mg bid whose MADRS score is > 10 at day 18, the dose may be increased to 15 mg bid."
16365563|NCT00129467|Drug|Placebo|"Subjects assigned to placebo will receive 1 capsule of placebo twice per day (bid) for 3 days and then 2 capsules bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of placebo, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%.
~If subjects have side effects when increasing the dose to 2 capsules bid, they will drop back to 1 capsule bid. If the participant develops psychosis or cardiac events, they will be discontinued from the intervention."
16365564|NCT00129467|Drug|Selective Serotonin Uptake Inhibitor (SSRI)|"Each subject will be treated with a SSRI. Patients who are taking an SSRI at the time of enrollment will continue on the same medication during the 18-day blind treatment period. The prescribed dose will only be adjusted if it is more than the highest dose in the recommended range (fluoxetine to 40 mg, paroxetine to 40 mg, citalopram to 40 mg, sertraline to 150 mg). Patients who are not on a SSRI at the time of enrollment will be prescribed citalopram 10 mg per day for 2 weeks, then 20 mg per day.
~A subject's SSRI may be discontinued if the subject experiences moderate to severe side effects likely attributable to a SSRI. If subjects experience similar symptoms when increasing their citalopram dose to 20 mg per day, they will drop back to 10 mg per day. During the open label extension, the SSRI may be increased, decreased, or changed to a different SSRI or other antidepressant with the exception of venlafaxine and bupropion"
16365565|NCT00129454|Behavioral|Cognitive Behavioral Therapy|"The investigators adapted two previously validated CBT manuals for use in both Telephone and In-Person groups (the Personal Health Improvement Program and Dr. Charles Engel's group treatment for GWI). Treatment included the following standard components of CBT: Didactic or educational material about the causes of GWI and an explanation of how thinking can cause stress (ABC model); Assessment of psychological distress and behavioral problems that may be targets of therapeutic intervention (e.g. symptom-related anxiety); Assessment of thinking errors that lead to psychological distress and trigger behavioral problems (e.g. catastrophizing); Cognitive restructuring to teach disputing skills or how to correct thinking errors; Cognitive and behavioral homework assignments (e.g. written self-disclosure); Didactic homework assignments (e.g. listen to previous treatment session)."
16365566|NCT00129454|Behavioral|Cognitive Behavioral Therapy|This description is the same as the experimental treatment only disseminated in person rather than over the telephone.
16365567|NCT00129441|Drug|Merck L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
16365568|NCT00129441|Drug|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
16365569|NCT00129428|Procedure|UVB Irradiation|A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
16365570|NCT00129415|Procedure|UVA1 Irradiation|The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source) for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2.
16365571|NCT00129415|Procedure|UVB Irradiation|The affected areas on the body will be treated with UVB light for up to 5 times per week for 16 weeks. The maximum UVB dose will be 4000 mJ/cm2.
16365572|NCT00129402|Drug|ezetimibe with simvastatin|Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks
16365573|NCT00129402|Drug|simvastatin|Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks
16365574|NCT00129389|Drug|Fluorouracil|Arm A: FAC Arm B: FAC-wP
16365575|NCT00129389|Drug|Doxorubicin|Arm A: FAC Arm B: FAC-wP
16365576|NCT00129389|Drug|Cyclophosphamide|Arm A: FAC Arm B: FAC-wP
16365577|NCT00129389|Drug|Paclitaxel|Arm B: FAC-wP
16365578|NCT00129376|Drug|Doxorubicin|
16365579|NCT00129376|Drug|Cyclophosphamide|
16365580|NCT00129376|Drug|Docetaxel|
16365581|NCT00129363|Drug|Carvedilol|
16365582|NCT00129350|Procedure|Pulmonary rehabilitation programme|
16365583|NCT00129337|Drug|Bavituximab|Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
16365584|NCT00129324|Procedure|Lead Hazard Control Intervention|Prior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead.
16365585|NCT00129324|Procedure|Injury Hazard Control Intervention|Between 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries.
16365586|NCT00129311|Drug|Selegiline|5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
16365587|NCT00129311|Drug|Placebo|
16365588|NCT00129298|Drug|Tiagabine|The tiagabine group will start receiving tiagabine 4mg in the evening of the first day on week 2. The dose will be titrated every third day, until the target dose of 32mg/day is achieved by week 5. The study medication must be titrated to 32 mg/day or to the subject's maximum tolerated dose (MTD).
16365589|NCT00129285|Drug|Low Dose Modafinil|modafinil 200 mg/day
16365590|NCT00129285|Drug|High Dose Modafinil|modafinil 400 mg/day
16365591|NCT00129285|Drug|Placebo|placebo 400 mg/day
16365592|NCT00129272|Drug|Bupropion-SR|150mg tablets taken orally twice daily for 9 weeks.
16365593|NCT00129272|Other|Placebo|Matching placebo (to Buproion-SR) twice daily for 9 weeks.
16365594|NCT00129259|Biological|Anti-CD3 mAb|Daily 14-day dose escalation course at study entry, with possible second course after 12-month interval
16365595|NCT00129259|Other|Diabetes Standard of Care Treatment|Receipt of intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
16365596|NCT00129259|Dietary Supplement|Iron supplementation|Immediately following randomization, all participants regardless of arm allocation begin iron supplementation with either ferrous sulfate or multivitamin with iron.
16365597|NCT00129246|Drug|Naltrexone|Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
16365598|NCT00129246|Drug|Bupropion|Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
16365599|NCT00129233|Drug|Valsartan|valsartan 80 to 160 mg daily
16365600|NCT00129233|Drug|Amlodipine|Amlodipine 5 to 10 mg daily.
16365601|NCT00129220|Drug|olanzapine|5-20 mg, oral, once daily (evening), for 6 weeks
16365602|NCT00129220|Drug|haloperidol|2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
16365603|NCT00129220|Drug|placebo|placebo, oral tablets, twice daily (morning and evening), for 3 weeks
16365604|NCT00129207|Drug|bortezomib|
16365605|NCT00129194|Drug|KP-1461|
16365606|NCT00129181|Drug|cabergoline|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
16365607|NCT00129181|Drug|carbidopa/levodopa|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
16365608|NCT00129181|Procedure|DATscan and SPECT imaging|Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
16365609|NCT00129168|Drug|Zosuquidar|
16365614|NCT00129129|Biological|GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine|Primary phase: 3 IM doses Booster phase: 1 IM dose
16365615|NCT00129129|Biological|ActHIB|Primary phase: 3 IM doses Booster phase: 1 IM dose
16365616|NCT00129129|Biological|Pediarix|Primary phase: 3 IM doses
16365617|NCT00129129|Biological|Prevnar|Primary phase: 3 IM doses Booster phase: 1 IM dose
16365618|NCT00129129|Biological|Menomune|Primary phase: 1 SC dose
16365619|NCT00129116|Biological|Hib-MenCY-TT vaccine|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
16365620|NCT00129116|Biological|Hib-MenC-TT vaccine|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
16365621|NCT00129116|Biological|Menjugate ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
16365622|NCT00129116|Biological|Infanrix penta ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
16365623|NCT00129116|Biological|Infanrix hexa ®|Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
16365624|NCT00129090|Drug|R-CHOEP 14 with 12x Rituximab|after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
16365625|NCT00129077|Procedure|plastic wrap over eye & lubrication applied q6 hrs|
16365626|NCT00129064|Behavioral|Electronic referral system|
16365627|NCT00129051|Procedure|Tomotherapy|
16365628|NCT00129038|Drug|modified-release dipyridamole/aspirin|
16365629|NCT00129038|Drug|aspirin|
16365630|NCT00129025|Procedure|Hypofractionated radiotherapy|
16365631|NCT00129012|Procedure|Tomotherapy|
16365632|NCT00128999|Procedure|Intensity-Modulated Radiation Therapy|
16365633|NCT00128986|Procedure|Tomotherapy|3T MRS scans (3T magnetic resonance spectroscopy)
16365634|NCT00128947|Drug|Mycophenolic Acid|
16365635|NCT00128947|Drug|Mycophenolate 7-O-Phenolic Glucuronide|
16365636|NCT00128934|Drug|levonorgestrel/ethinyl estradiol|
16365637|NCT00128921|Drug|VELCADE™|"Patients will receive two cycles of VELCADE™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21 day cycle. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured:
~Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 hours for 8 hours Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample (+/- 2 hours) Other laboratory and radiologic studies will be performed as detailed in the Study Calendar.
~Patients will complete the study after two cycles of VELCADE™. However, if a patient continues to receive VELCADE™ as part of his/her treatment for relapsing MM, routine bone markers may be monitored for the duration of VELCADE™ treatment as clinically indicated."
16365638|NCT00128908|Drug|Standard Continuous Highly Active Antiretroviral Therapy (HAART)|
16365639|NCT00128908|Drug|Rapidly Cycled HAART|
16365640|NCT00128895|Drug|azathioprine|azathioprine 2 mg/kg oral once daily, duration according to arm
16365641|NCT00128882|Drug|Anti-D|Subcutaneous injection
16365642|NCT00128869|Procedure|spine mobilizations|
16365643|NCT00128869|Procedure|spine manipulations|
16365644|NCT00128856|Drug|Gemcitabine|
16365645|NCT00128856|Drug|Adriamycine|
16365646|NCT00128856|Drug|Paclitaxel|
16365647|NCT00128843|Drug|Exemestane|25mg/day until progression disease
16365648|NCT00128843|Drug|Anastrozole|1mg/day until progression disease
16365649|NCT00128830|Drug|Etravirine (ETR)|Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available.
16365650|NCT00128830|Drug|Nucleotide reverse transcriptase inhibitors (NRTIs)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
16365651|NCT00128830|Drug|Protease inhibitors (PIs)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
16365652|NCT00128830|Drug|Enfuvirtide (ENF)|Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
16365653|NCT00128817|Radiation|Concurrent Chemoradiation|60-70 Gy at 2Gy/5days a week for 6 to 7 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
16365654|NCT00128817|Procedure|Laryngectomy + adjuvant radiotherapy/chemoradiotherapy|Surgery: Total Laryngectomy with or without partial pharyngectomy or Near-Total Laryngectomy with or wothout partial pharyngectomy Adjuvant Radiation 2- 3 weeks following surgery: 50-60Gy at 2Gy/5days a week for 5 to 6 weeks Cisplatin (CDDP) 100 mg/m2 over 20-30 minutes on days 1, 22, and 43.
16365655|NCT00128804|Behavioral|absorption and conversion of beta-carotene in human gastrointestinal (GI) tract|
16365656|NCT00128791|Drug|Nitroprusside|
16365657|NCT00128778|Drug|Pegylated liposomal doxorubicin|
16365658|NCT00128765|Behavioral|an integrated self-management education program|disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
16365659|NCT00128765|Behavioral|regular practice nurse review (monitoring controls)|protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
16365660|NCT00128765|Behavioral|care at initiative of the patient (usual GP care)|care at initiative of the patient (usual GP care)
16365661|NCT00128752|Behavioral|absorption and conversion of beta-carotene in human gastrointestinal (GI) tract|
16365662|NCT00128739|Drug|Budesonide|
16365663|NCT00128713|Procedure|Medium Dose Prophylactic Platelet Transfusions|2.2 x 10^11 platelets per m^2 BSA
16365664|NCT00128713|Procedure|Lower Dose Prophylactic Platelet Transfusions|1.1 x 10^11 platelets per m^2 BSA
16365665|NCT00128713|Procedure|Higher Dose Prophylactic Platelet Transfusions|4.4 * 10^11 platelets per m^2 BSA
16365666|NCT00128700|Drug|temozolomide|
16365667|NCT00128700|Drug|vatalanib|
16365668|NCT00128700|Procedure|adjuvant therapy|
16365670|NCT00128687|Behavioral|risk reduction|Participants receive intensive case management for CHD risk reduction for 15 months and then a maintenance program for a minimum of 12 months. Lifestyle modification was strongly emphasized as a critical component of achieving CHD prevention goals. Dietary management was emphasized, including recommendation of a low saturated fat (less than 7% of caloric intake), low cholesterol (< 150 mg/day), mainly plant-based diet with calorie restrictions for overweight/obese persons. Stress management and coping skills were emphasized, including a regular exercise regimen (≥ 30 minutes of moderate intensity on most days). Cigarette smokers were encouraged to join a stop smoking program.
16365671|NCT00128661|Biological|human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine|Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule
16365672|NCT00128661|Biological|hepatitis A inactivated virus vaccine|Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule
16365673|NCT00128635|Radiation|iodine I 131 monoclonal antibody TNT-1/B|
16365674|NCT00128622|Biological|denileukin diftitox|
16365675|NCT00128622|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
16365676|NCT00128622|Biological|therapeutic autologous dendritic cells|
16365677|NCT00128596|Drug|arsenic trioxide|
16365678|NCT00128583|Biological|polyvalent melanoma vaccine|
16365679|NCT00128570|Behavioral|behavioral dietary intervention|
16365680|NCT00128570|Other|educational intervention|
16365681|NCT00128570|Other|internet-based intervention|
16365682|NCT00128570|Other|preventative dietary intervention|
16365683|NCT00128570|Procedure|evaluation of cancer risk factors|
16365684|NCT00128557|Drug|vitamin A supplementation (50,000 IU)|
16365685|NCT00128544|Drug|telbivudine|
16365686|NCT00128544|Drug|valtorcitabine|
16365687|NCT00128531|Drug|leuprolide acetate|
16365688|NCT00128518|Drug|Indapamide (T2)|1.5 mg/day during 4 weeks
16365689|NCT00128518|Drug|Perindopril (T1)|4 mg/day during 1 week then 8 mg/day during 3 weeks
16365690|NCT00128518|Drug|Placebo of Perindopril (P1)|1 pill/day during 1 week then 2 pills/day during 3 weeks
16365691|NCT00128518|Drug|Placebo of Indapamide (P2)|1 pill/day during 4 weeks
16365692|NCT00128505|Drug|Mifepristone|
16365693|NCT00128492|Drug|AZLI 75 mg two times a day (BID)/ three times a day (TID)|
16365694|NCT00128479|Drug|mifepristone|mifepristone 300 mg daily for 7 dats
16365695|NCT00128479|Drug|mifepristone matched placebo|daily for 7 days
16365696|NCT00128479|Drug|mifepristone 600 mg|mifepristone 600 mg daily for 7 days
16365697|NCT00128479|Drug|mifepristone 1200 mg|mifepristone 1200 mg daily for 7 days
16365698|NCT00128466|Drug|gentamicin|
16365699|NCT00128466|Drug|streptomycin|
16365700|NCT00128453|Drug|Colchicine (for 3 months)|Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
16365701|NCT00128453|Drug|Placebo|placebo
16365702|NCT00128440|Drug|BEA 2180 BR|
16365703|NCT00128440|Drug|tiotropium|
16365704|NCT00128427|Drug|Colchicine (for 1 month)|
16365705|NCT00128414|Drug|Colchicine (for 6 months)|colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
16365706|NCT00128414|Drug|Placebo|Tablets identical in colour, shape, and taste were provided in blister packs.
16365707|NCT00128401|Drug|D-Cycloserine|
16365708|NCT00128401|Drug|Placebo|
16365709|NCT00128388|Other|PFPP|Psychoanalytic Psychotherapy for panic disorder
16365710|NCT00128388|Other|ART|Applied Relaxation Training
16365711|NCT00128375|Behavioral|Financial incentives|
16365712|NCT00128362|Procedure|Radio-guided sentinel node biopsy|
16365713|NCT00128362|Procedure|Axillary sampling|
16365714|NCT00128336|Behavioral|Lifestyle: diet and exercise intervention|
16365715|NCT00128323|Drug|Gentian violet 1% solution|
16365716|NCT00128323|Drug|Gentian violet 0.00165% solution|
16365717|NCT00128323|Drug|Nystatin solution|
16365718|NCT00128310|Drug|Vinorelbine|
16365719|NCT00128310|Drug|Gemcitabine|
16365720|NCT00128297|Drug|Pamidronate|
16365721|NCT00128271|Drug|Bavituximab|
16365722|NCT00128258|Procedure|Injection of bone marrow cells in the heart|Biological implant into the heart
16365723|NCT00128258|Biological|Biological bone marrow cell therapy|Biological implant into the heart
16365724|NCT00128245|Drug|Pimecrolimus|
16365725|NCT00128245|Drug|Vehicle|Placebo
16365726|NCT00128232|Drug|Octreotide LAR|
16365727|NCT00128219|Biological|GBS III-TT|50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.
16365728|NCT00128219|Biological|Tetanus and diptheria toxoids vaccine|Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.
16365729|NCT00128206|Drug|Isoniazid|Isoniazid 900 mg twice weekly
16365730|NCT00128206|Drug|Rifampin|Rifampin 600mg once per day
16365731|NCT00128193|Biological|Tuberculin, Purified Protein Derivative|A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose
16365732|NCT00128193|Other|MLSA-LAM|Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
16365733|NCT00128193|Other|MLCwA|Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
16365734|NCT00128193|Biological|Tuberculin, Purified Protein Derivative|Licensed TB reagent, 100 microliters, 5 TU dose.
16365735|NCT00128193|Other|Placebo|Saline (NaCl) serves as a diluent control in Stage A and B only.
16365806|NCT00127699|Procedure|Alcohol swab of umbilical cord|
16365807|NCT00127686|Drug|Dextromethorphan|
16365808|NCT00127686|Drug|Buckwheat Honey|
16372574|NCT00086632|Drug|oregovomab|
16365736|NCT00128180|Drug|Methylprednisolone|Intravenous methylprednisolone 16 mg/kg/day for 3 days as follows: 8 mg/kg (up to 500 mg) given over first hour followed by 8 mg/kg over the next 23 hours; then 16 mg/kg (up to 1000 mg) on days 2 and 3 administered over 24 hours.
16365737|NCT00128180|Drug|Placebo|Placebo
16365738|NCT00128167|Drug|Liquid CAIV-T|
16365739|NCT00128154|Drug|Chromium picolinate|
16365740|NCT00128141|Behavioral|Tactile stimulus|four times a day
16365741|NCT00128128|Drug|Cranberry juice cocktail|Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
16365742|NCT00128115|Drug|MK0677|
16365743|NCT00128102|Drug|Vorinostat|Vorinostat 100 mg oral capsules
16365744|NCT00128102|Drug|Placebo|Vorinostat-matching placebo oral capsules
16365745|NCT00128089|Behavioral|Dietary treatment|
16365746|NCT00128076|Procedure|All-Arthroscopic repair|joint techniques and repair are both performed entirely through the arthroscope
16365747|NCT00128076|Procedure|Mini-open repair|repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
16365748|NCT00128063|Drug|succinylated human serum albumin|
16365749|NCT00128050|Drug|rFactor VIIa (Eptacog alfa, NovoNordisk)|rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.
16365750|NCT00128050|Drug|rFVIIa|Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation
16365751|NCT00128050|Other|Sodiun chloride 0.9%|Bolus injection of sodium chloride 0.9% after surgical hematoma removal
16365752|NCT00128037|Drug|mitomycin C, vindesine, cisplatin and radiotherapy|
16365753|NCT00128024|Drug|lipid-lowering treatment|
16365754|NCT00128011|Biological|killed oral cholera vaccine|
16365755|NCT00127998|Drug|chloroquine|
16365756|NCT00127998|Drug|sulfadoxine-pyrimethamine|
16365757|NCT00127998|Drug|amodiaquine|
16365758|NCT00127998|Drug|amodiaquine+artesunate|
16365759|NCT00127998|Drug|amodiaquine+sulfadoxine-pyrimethamine|
16365760|NCT00127998|Drug|sulfadoxine-pyrimethamine+artesunate|
16365761|NCT00127998|Drug|artemether-lumefantrine|
16365762|NCT00127998|Drug|mefloquine|
16365763|NCT00127985|Drug|6-methyl-prednisolone|iv, 2 mg/kg/day, qid
16365764|NCT00127972|Drug|stavudine|
16365765|NCT00127972|Drug|lamivudine|
16365766|NCT00127972|Drug|nevirapine|
16365767|NCT00127972|Drug|efavirenz|
16365768|NCT00127972|Drug|trizivir|
16365769|NCT00127959|Drug|tenofovir|
16365770|NCT00127959|Drug|emtricitabine|
16365771|NCT00127959|Drug|zidovudine|
16365772|NCT00127959|Drug|efavirenz|
16365773|NCT00127946|Procedure|AMNIOECHANGE|The AMNIOECHANGE consists of a transabdominal infusion of saline (heated to 37 ° C) with a needle 18 or 20 gauge under ultrasound monitoring while avoiding the placenta. In the case of a normal amniotic fluid, it must be replaced volume per volume of saline (eg depending on the tank where the puncture is made, it can be 300 per 300 ml). The total amount of amniotic fluid exchange is 600-900 ml. In cases of oligohydramnios, the AMNIOECHANGE results in a normalized volume of amniotic fluid.
16365774|NCT00127933|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
16365775|NCT00127933|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
16365776|NCT00127933|Drug|Herceptin (HER2-neu positive patients only)|4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
16365777|NCT00127933|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
16365778|NCT00127933|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
16365779|NCT00127920|Drug|Avastin|Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days
16365780|NCT00127907|Drug|epinephrine (1 mg/1 mL)|
16365781|NCT00127907|Drug|arginine-vasopressin (40 UI/2 mL)|
16365782|NCT00127881|Drug|HuMax-CD4 (zanolimumab)|Monoclonal Antibody, 12 weekly infusions.
16365783|NCT00127868|Drug|oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo|
16365784|NCT00127855|Biological|Hib-MenCY-TT vaccine (MenHibrix)|Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
16365785|NCT00127855|Biological|Meningitec®|Three doses were administered IM in right lower thigh at Months 0,2 and 4.
16365786|NCT00127855|Biological|ActHIB®|Three doses were administered IM in left thigh at Months 0,2 and 4.
16365787|NCT00127855|Biological|Infanrix® Penta|Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
16365788|NCT00127855|Biological|Prevenar®|Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
16365789|NCT00127855|Biological|Mencevax® ACWY|One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
16365790|NCT00127855|Biological|PRP (Polyribosyl Ribitol Phosphate)|One dose was administered IM in deltoid region of left arm at Month 10 as booster.
16365791|NCT00127842|Drug|Etanercept|Administered according to the product monograph by subcutaneous (SC) injection
16365792|NCT00127829|Drug|Gefitinib|Oral tablet
16365793|NCT00127816|Procedure|Permanent prostate implant|
16365794|NCT00127803|Biological|Placebo (vaccine diluent)|0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
16365795|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
16365796|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
16365797|NCT00127803|Biological|Clostridium difficile vaccine|0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
16365798|NCT00127790|Behavioral|CBT for Insomnia (CBT-I)|
16365799|NCT00127790|Behavioral|CBT for Pain (CBT-P)|
16365800|NCT00127777|Drug|Amantadine sulphate (in addition to standard treatment)|
16365801|NCT00127764|Drug|dexamethasone (50mg 1dd6, 3 consecutive days/month)|
16365802|NCT00127751|Behavioral|Enhance health lifestyle changes and medication compliance|
16365803|NCT00127738|Procedure|Angiographic renal revascularization|
16365804|NCT00127725|Device|Pulsed electromagnetic field stimulation|
16365805|NCT00127712|Drug|Amiodarone|
16365987|NCT00126399|Drug|doxycycline|
16365809|NCT00127673|Drug|Sertraline|The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
16365810|NCT00127673|Behavioral|Cognitive behavioral therapy (CBT)|CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
16365811|NCT00127660|Behavioral|Menu: calories=yes, value pricing=no|
16365812|NCT00127660|Behavioral|Menu: calories=yes, value pricing = yes|
16365813|NCT00127660|Behavioral|Menu: calories=no, value pricing = no|
16365814|NCT00127647|Drug|montelukast sodium|montelukast sodium; 5 mg, 10 mg QD 2-weeks.
16365815|NCT00127647|Drug|Comparator: pranlukast|Pranlukast 225 mg BID 2-weeks.
16365816|NCT00127634|Drug|Human Insulin Inhalation Powder|patient specific dose, inhaled, before meals, 24 months, up to 36 months
16365817|NCT00127634|Drug|Injectable Insulin|patient specific dose, injectable, before meals, 24 months, up to 36 months.
16365818|NCT00127634|Drug|Insulin Glargine|patient specific dose, injectable, as needed, 24 months up to 36 months
16365819|NCT00127621|Procedure|early tracheotomy|
16365820|NCT00127621|Procedure|prolonged endotracheal intubation|
16365821|NCT00127608|Procedure|Collection of clinical samples|"The following samples were obtained from each subject:
~Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
~Papule swabs (PS) from four papules
~Crusts from two lesions
~One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.
~After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique."
16365822|NCT00127595|Drug|gemcitabine, oxaliplatin|
16365823|NCT00127582|Procedure|Electrophysiological study|
16365824|NCT00127582|Device|pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant|
16365825|NCT00127569|Drug|Rituximab|
16365826|NCT00127556|Procedure|Label applied to blood bag|
16365827|NCT00127543|Behavioral|Medication Education for Children|
16365828|NCT00127530|Drug|Fampridine-SR|Tablets, 10 mg, twice daily, 14 weeks
16365829|NCT00127530|Drug|Placebo|sugar pill, twice a day (b.i.d.)
16365830|NCT00127517|Drug|peptide-nucleic acid solution AVR118|
16365831|NCT00127504|Drug|Rifampin|
16365832|NCT00127504|Drug|Azithromycin|
16365833|NCT00127491|Procedure|Placement of an esophageal balloon measurements|In both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed.
16365834|NCT00127491|Other|Low tidal volume ventilation|Low tidal volume ventilation strategy (ARDSnet)
16365835|NCT00127491|Other|Transpulmonary pressure-directed ventilation (EPVent)|Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
16365836|NCT00127478|Drug|Atrasentan|
16365837|NCT00127465|Procedure|Issue of information booklet|
16365838|NCT00127452|Dietary Supplement|margarine spread|Daily use of margarine spread (approximately 20 grams) during 40 months
16365839|NCT00127439|Procedure|Manually Assisted Locomotor Training|The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
16365840|NCT00127439|Other|Robotic Assisted Locomotor Training|The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
16365841|NCT00127413|Behavioral|Cognitive Behavioral Therapy - Pain|Pain treatment
16365842|NCT00127413|Behavioral|Cognitive Behavioral Therapy-Integrated|Integrated treatment
16365843|NCT00127413|Behavioral|Cognitive Processing Therapy - PTSD|Cognitive processing therapy
16365844|NCT00127413|Behavioral|Treat as Usual|Treatment as usual
16365845|NCT00127400|Behavioral|anger management therapy|
16365846|NCT00127387|Drug|Enbrel|
16365847|NCT00127374|Behavioral|Dietary and physical activity modifications|
16365848|NCT00127361|Behavioral|doula training|
16365849|NCT00127348|Device|CPAP (Continuous Positive Airway Pressure)|
16365850|NCT00127335|Drug|cellulose placebo vs. atorvastatin|drug
16365851|NCT00127309|Drug|Glutathione|
16365852|NCT00127296|Device|FlexPen®|
16365853|NCT00127296|Device|vial and syringe|
16365854|NCT00127283|Drug|eptacog alfa (activated)|
16365855|NCT00127270|Drug|Darifenacin|Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
16365856|NCT00127270|Drug|Darifenacin|Darifenacin tablets 7,5 mg or 15 mg once daily
16365857|NCT00127270|Behavioral|Behavioral therapy|Behavioral Modification Programme for symptoms of overactive bladder
16365858|NCT00127257|Behavioral|Biofeedback|
16365859|NCT00127257|Drug|Diazepam|
16365860|NCT00127257|Behavioral|Pelvic floor retraining|
16365861|NCT00127244|Procedure|Periodontal Treatment|
16365988|NCT00126386|Drug|Zoledronic acid (Zometa)|
16365989|NCT00126373|Drug|Wellbutrin (bupropion)|bupropion 150mg-300mg daily
16365862|NCT00127231|Behavioral|Brief alcohol intervention based on Project Treat|The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
16365863|NCT00127231|Behavioral|Standard care|Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
16365864|NCT00127218|Drug|any statin|Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months
16365865|NCT00127218|Drug|niacin|long-acting niacin daily for 18 months
16365866|NCT00127218|Drug|Placebo|matching placebo pill daily for 18 months
16365867|NCT00127205|Drug|clodronate disodium|Given orally
16365868|NCT00127205|Drug|ibandronate sodium|Given orally
16365869|NCT00127205|Drug|zoledronic acid|Given IV
16365870|NCT00127192|Drug|sitagliptin phosphate|sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
16365871|NCT00127192|Drug|Comparator: placebo (unspecified)|placebo QD 12-weeks
16365872|NCT00127179|Drug|MK0906, finasteride / Duration of Treatment: 48 weeks|
16365873|NCT00127179|Drug|Comparator: placebo / Duration of Treatment: 48 weeks|
16365874|NCT00127166|Drug|Montelukast sodium|Montelukast 5 mg chewable tablet once daily
16365875|NCT00127166|Drug|Salmeterol xinafoate|Salmeterol 50 mcg dry powder per actuation inhaled twice daily
16365876|NCT00127166|Drug|Fluticasone propionate|Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
16365877|NCT00127166|Drug|Montelukast matching placebo|Matching placebo to montelukast oral tablet administered once daily.
16365878|NCT00127166|Drug|Salmeterol matching placebo|Matching placebo to salmeterol dry powder for inhalation administered twice daily
16365879|NCT00127153|Biological|V110, pneumococcal vaccine polyvalent|
16365880|NCT00127140|Drug|vorinostat|
16365881|NCT00127127|Drug|vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
16365882|NCT00127114|Drug|Amantadine|
16365883|NCT00127114|Drug|Placebo|
16365884|NCT00127101|Drug|vorinostat|Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
16365885|NCT00127101|Drug|Comparator: bexarotene|Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
16365886|NCT00127088|Drug|docetaxel|
16365887|NCT00127088|Procedure|laparoscopic radical prostatectomy|
16365888|NCT00127075|Drug|nomegestrol acetate|10 mg/day
16365889|NCT00127075|Drug|estradiol|75 mcg, once a week
16365890|NCT00127075|Drug|placebo|matching placebo treatments
16365891|NCT00127062|Other|Oxford street|2 h walk around Oxford street
16365892|NCT00127062|Other|Hyde park|2 h walk around Hyde park
16365893|NCT00127049|Drug|gemcitabine, ifosfamide, cisplatin, G-CSF|
16365894|NCT00127036|Drug|XELOX|XELOX: Oxaliplatin 130 mg/m^2 intravenously (IV); Capecitabine 825 mg/m^2 by mouth (po)
16365895|NCT00127036|Drug|XELIRI|XELIRI: Irinotecan 240 mg/m^2 IV; Capecitabine 825 mg/m^2 by mouth (po)
16365896|NCT00127036|Drug|Bevacizumab|7.5 mg/kg intravenously (IV)
16365897|NCT00127023|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
16365898|NCT00127010|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
16365899|NCT00126997|Biological|Measles, Mumps, Rubella and Chickenpox (live vaccine)|
16365900|NCT00126984|Biological|Conjugated meningococcal ACWY-TT (vaccine)|One intramuscular dose during the primary vaccination
16365901|NCT00126984|Biological|DTPa/Hib containing vaccine|One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
16365902|NCT00126984|Biological|Meningitec|One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
16365903|NCT00126984|Biological|Mencevax ACWY|One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
16365904|NCT00126971|Drug|chlorproguanil-dapsone|
16365905|NCT00126958|Procedure|urinary analysis|
16365906|NCT00126945|Biological|Meningococcal Vaccine|
16365907|NCT00126932|Device|SonoPrep|
16365908|NCT00126919|Device|SonoPrep|
16365909|NCT00126906|Drug|Monthly sulfadoxine/pyrimethamine|
16365910|NCT00126906|Drug|2-dose sulfadoxine/pyrimethamine|
16365911|NCT00126893|Drug|CC-401|
16365912|NCT00126880|Drug|AVX754|apricitabine, 600mg BID or 800mg BID
16365913|NCT00126880|Drug|3TC|3TC, 150mg BID
16365914|NCT00126854|Procedure|Magnetic Resonance Spectroscopy Imaging|
16365915|NCT00126841|Procedure|CT and MR fusion|
16365916|NCT00126828|Procedure|External beam radiotherapy|
16365917|NCT00126802|Procedure|Tomotherapy|Standard 45 Gy in 25 fractions in 5 weeks
16365918|NCT00126789|Drug|Fentanyl Transdermal Matrix Patch ZR-02-01|ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
16365919|NCT00126776|Behavioral|case management|case/self management for COPD vs usual care
16365920|NCT00126776|Behavioral|usual care|usual care for COPD
16365990|NCT00126360|Drug|Timing of Anastrozole in respect to radiotherapy|
16365991|NCT00126347|Procedure|supplementation with betaine, serine, and folic acid|
16372797|NCT00003549|Drug|fluorouracil|
16365921|NCT00126763|Drug|Fentanyl Transdermal Matrix Patch ZR-02-01|ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days
16365922|NCT00126750|Behavioral|VA MI Plus Interactive|The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.
16365923|NCT00126737|Other|Weight Control Nutritional Program|a week of food diary and information about dietary fat intake and proper proportions of vegetables.
16365924|NCT00126737|Other|Home-based exercise program|24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
16365925|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^11 DRP/mL
16365926|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^11 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
16365927|NCT00126724|Genetic|tgAAC94 placebo|placebo
16365928|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^12 DRP/mL tgAAC94
16365929|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^12 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
16365930|NCT00126724|Genetic|tgAAC94 gene therapy vector|Single Dose 1x10^13 DRP/mL tgAAC94
16365931|NCT00126724|Genetic|tgAAC94 gene therapy vector|Second dose of 1x10^13 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.
16365932|NCT00126698|Drug|trimethoprim-sulfamethoxazole|
16365933|NCT00126698|Drug|ciprofloxacin|
16365934|NCT00126685|Biological|autologous tumor cell vaccine|
16365935|NCT00126685|Biological|therapeutic autologous dendritic cells|
16365936|NCT00126672|Drug|sirolimus|
16365937|NCT00126659|Procedure|therapeutic conventional surgery|Undergo cytoreductive nephrectomy
16365938|NCT00126659|Drug|sorafenib tosylate|Given orally
16365939|NCT00126659|Other|laboratory biomarker analysis|Correlative studies
16365940|NCT00126646|Drug|BL22 immunotoxin|
16365941|NCT00126646|Procedure|antibody-drug conjugate therapy|
16365942|NCT00126646|Procedure|immunotoxin therapy|
16365943|NCT00126633|Biological|bevacizumab|
16365944|NCT00126633|Drug|cisplatin|
16365945|NCT00126633|Drug|gemcitabine hydrochloride|
16365946|NCT00126620|Drug|erlotinib hydrochloride|
16365947|NCT00126620|Drug|sorafenib tosylate|
16365948|NCT00126607|Biological|trastuzumab|Given IV
16365949|NCT00126607|Other|laboratory biomarker analysis|Correlative studies
16365950|NCT00126594|Drug|Sorafenib Tosylate|Given orally 400 mg orally (PO) every 12 hours
16365951|NCT00126594|Biological|Recombinant Interferon Alfa-2b|Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10^6 international units twice daily
16365952|NCT00126594|Other|Laboratory Biomarker Analysis|Correlative studies
16365953|NCT00126581|Drug|Carboplatin|Given IV
16365954|NCT00126581|Drug|Erlotinib|Given PO
16365955|NCT00126581|Drug|Erlotinib Hydrochloride|Given PO
16365956|NCT00126581|Drug|Paclitaxel|Given IV
16365957|NCT00126568|Drug|sorafenib tosylate|Given orally
16365958|NCT00126555|Drug|Gefitinib|Oral Gefitinib induction therapy given daily for 2 months at 250 mg/day, once a day for 30 days (1 cycle = 30 days) with at least 2 cycles of treatment (60 days) given. After 2 months evaluate for clinical response (15 days) and resectability (60 days). If after 15 days with no tumor response, daily dose doubled (500 mg), and discontinuation if tumor progression.
16365959|NCT00126555|Radiation|Radiotherapy|Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.
16365960|NCT00126555|Procedure|Conventional surgery|Undergo surgery
16365961|NCT00126555|Other|laboratory biomarker analysis|Correlative studies
16365962|NCT00126542|Biological|bevacizumab|Given IV
16365963|NCT00126542|Drug|erlotinib hydrochloride|Given orally
16365964|NCT00126542|Other|laboratory biomarker analysis|Correlative studies
16365965|NCT00126516|Drug|Angiotensin II Receptor Antagonists|any dosage, frequency, and duration
16365966|NCT00126516|Drug|Angiotensin-converting Enzyme Inhibitors|any dosage, frequency, and duration
16365967|NCT00126503|Biological|Bevacizumab|Given IV
16365968|NCT00126503|Drug|Sorafenib Tosylate|Given PO
16365969|NCT00126503|Other|Pharmacological Study|Correlative studies
16365970|NCT00126503|Other|Laboratory Biomarker Analysis|Correlative studies
16365971|NCT00126490|Biological|Aldesleukin|Given subcutaneously
16365972|NCT00126490|Biological|Bevacizumab|Given IV
16365973|NCT00126490|Other|Laboratory Biomarker Analysis|Correlative studies
16365974|NCT00126477|Procedure|cognitive assessment|
16365975|NCT00126477|Procedure|management of therapy complications|
16365976|NCT00126477|Procedure|psychosocial assessment and care|
16365977|NCT00126477|Procedure|quality-of-life assessment|
16365978|NCT00126464|Drug|fulvestrant|
16365979|NCT00126464|Drug|tamoxifen citrate|
16365980|NCT00126464|Procedure|conventional surgery|
16365981|NCT00126464|Procedure|neoadjuvant therapy|
16365982|NCT00126451|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|
16365983|NCT00126451|Drug|Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles|
16365984|NCT00126438|Drug|123I-mIBG (meta-iodobenzylguanidine)|Single Dose
16365985|NCT00126425|Drug|123I-mIBG (meta-iodobenzylguanidine)|Single dose
16365986|NCT00126412|Drug|123I-mIBG (meta-iodobenzylguanidine)|
16365992|NCT00126334|Procedure|Packed Red Blood Cell Transfusion|transfusion of 1 unit of PRBCs
16365993|NCT00126321|Drug|cladribine|2-chlorodeoxyadenosine, 2-CdA
16365994|NCT00126308|Device|poly-L-lactic acid|immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
16365995|NCT00126308|Device|poly-L-lactic acid|delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
16365996|NCT00126295|Device|'What you need to know about stroke' education package|
16365997|NCT00126282|Behavioral|behavior therapy|
16365998|NCT00126282|Drug|D-Cycloserine|
16365999|NCT00126269|Drug|cisplatin|
16366000|NCT00126269|Drug|gemcitabine|
16366001|NCT00126256|Drug|5-fluorouracil|
16366002|NCT00126256|Drug|leucovorin|
16366003|NCT00126256|Drug|irinotecan|
16366004|NCT00126256|Drug|oxaliplatin|
16366005|NCT00126243|Drug|rituximab|
16366006|NCT00126243|Drug|CHOP|
16366007|NCT00126230|Drug|docetaxel and samarium|
16366008|NCT00126217|Biological|Bacille Calmette Guerin (BCG)|0,1 ml, revaccination at 19 months of age
16366009|NCT00126204|Drug|Doxycycline|
16366010|NCT00126191|Drug|Rituximab|Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1
16366011|NCT00126191|Drug|Cyclophosphamide|Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
16366012|NCT00126191|Drug|Doxorubicin|Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
16366013|NCT00126191|Drug|Vincristine|Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
16366014|NCT00126191|Drug|Methotrexate|Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle
16366015|NCT00126191|Drug|Leucovorin|Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
16366016|NCT00126191|Drug|Ifosfamide|High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
16366017|NCT00126191|Drug|Etoposide|High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
16366018|NCT00126191|Drug|Cytarabine|Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle
16366019|NCT00126191|Drug|Mesna|High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle
16366020|NCT00126178|Biological|HSPPC-96|
16366021|NCT00126165|Procedure|radiotherapy|
16366022|NCT00126152|Behavioral|Exercise, education and medical management|
16366023|NCT00126139|Drug|Abciximab|
16366024|NCT00126126|Other|EBAR Program|Evidence Based Amputee Rehabilitation Program
16366025|NCT00126113|Behavioral|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
16366026|NCT00126113|Behavioral|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
16366027|NCT00126100|Drug|G-CSF Granulocyte-Colony Stimulating Factor|Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
16366028|NCT00126100|Other|Placebo|Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.
16366029|NCT00126087|Drug|dopamine|
16366030|NCT00126074|Drug|Tedisamil sesquifumarate|
16366031|NCT00126061|Drug|Tedisamil sesquifumarate|
16366032|NCT00126048|Drug|Atorvastatin|40mg tablet
16366033|NCT00126048|Drug|Placebo|Placebo tablet
16366034|NCT00126035|Device|Migraid|
16366035|NCT00126022|Drug|Tedisamil sesquifumarate|
16366036|NCT00126009|Drug|Amisulpride|
16366037|NCT00125996|Drug|Venofer (intravenous iron sucrose)|
16366038|NCT00125983|Drug|Lopinavir/ritonavir|
16366039|NCT00125983|Drug|Ortho Novum 1/35|
16366040|NCT00125983|Drug|Ortho Evra|
16366041|NCT00125970|Biological|VRC-HIVDNA016-00-VP|4 mg administered in deltoid
16366042|NCT00125970|Biological|VRC-HIVADV014-00-VP|1 x 10^10 PU administered in deltoid
16366043|NCT00125970|Biological|VRC-HIVDNA016-00-VP placebo|1 mL administered at study entry and Months 1 and 2
16366044|NCT00125970|Biological|VRC-HIVADV014-00-VP placebo|1 mL administered at Month 6
16366045|NCT00125957|Drug|Wellbutrin|
16366046|NCT00125957|Drug|Placebo|
16366047|NCT00125944|Biological|FluMist|
16366048|NCT00125931|Drug|Talwin Nx|Talwin NX 50mg po twice
16366049|NCT00125918|Drug|tadalafil|tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
16366050|NCT00125918|Drug|tadalafil|tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
16366051|NCT00125918|Drug|tadalafil|tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
16366052|NCT00125918|Drug|tadalafil|tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
16366053|NCT00125918|Drug|placebo|placebo tablet taken by mouth once a day for 16 weeks
16366054|NCT00125905|Behavioral|Advice|
16366055|NCT00125905|Behavioral|Motivational Interviewing|
16366056|NCT00125905|Drug|Nicotine Gum and Patch|
16366057|NCT00125905|Drug|Bupropion|
16366058|NCT00125892|Drug|duloxetine|
16366059|NCT00125879|Biological|Myozyme|20 mg/kg qow or 40 mg/kg qow
16366060|NCT00125866|Behavioral|Flavonoid rich or flavonoid depleted chocolate drink|
16366061|NCT00125853|Drug|Nebivolol|Nebivolol 2.5mg daily
16366062|NCT00125853|Drug|Atenolol|Atenolol 25mg daily
16366063|NCT00125840|Drug|clofarabine (IV formulation)|
16366064|NCT00125827|Drug|clofarabine (oral formulation)|Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.
16366065|NCT00125814|Drug|Interferon alfa-2b|
16366066|NCT00125814|Procedure|Structured treatment interruptions|
16366067|NCT00125801|Drug|Subcutaneous hydromorphone delivered by pain pen|Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.
16366068|NCT00125788|Drug|L-glutamine|Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
16366069|NCT00125788|Drug|Placebo|Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
16366070|NCT00125775|Biological|Engerix-B|Engerix-B at 0, 1, 6 months
16366071|NCT00125762|Device|FibroScan|
16366072|NCT00125749|Biological|Dendritic cell vaccination|Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells
16366073|NCT00125736|Drug|E0671|One 50 mg capsule is orally administered three times daily (150 mg/day)
16366074|NCT00125736|Drug|rabeprazole sodium|One 10mg tablet is administered orally each day
16366075|NCT00125736|Drug|E0671 placebo|One 50 mg capsule is orally administered three times daily (150 mg/day)
16366076|NCT00125723|Other|PI Discretion|PI Discretion
16366077|NCT00125697|Procedure|3T MRI Scanning|pre-radiation therapy, week 4 radiation therapy, 2 months post radiation therapy and every 4 months for the first year
16366078|NCT00125684|Drug|morphine|
16366079|NCT00125671|Drug|Warfarin|
16366080|NCT00125658|Other|Control|Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
16366081|NCT00125658|Other|Experimental|Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
16366082|NCT00125645|Drug|Irbesartan Oral Tablet|
16366083|NCT00125632|Procedure|Eccentric Viewing Training for Reading|
16366084|NCT00125619|Behavioral|Locomotor training|This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.
16366085|NCT00125606|Procedure|conditioning for allogeneic HSCT|
16366086|NCT00125593|Drug|Simvastatin 20 mg|Once daily
16366087|NCT00125593|Drug|Ezetimibe 10mg|Once daily
16366088|NCT00125593|Drug|Placebo|Once daily
16366089|NCT00125580|Behavioral|Infant sleep instruction|
16366090|NCT00125567|Drug|Stalevo (levodopa/carbidopa/entacapone)|Oral, 50-150 mg levodopa four times daily, for up to 2 years
16366091|NCT00125567|Drug|Levodopa/carbidopa|Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
16366092|NCT00125554|Drug|Metyrapone|
16366093|NCT00125541|Drug|C1 inhibitor concentrate (C1-esteraseremmer-N)|every 5-7 days
16366094|NCT00125528|Drug|D-cycloserine|D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
16366095|NCT00125528|Drug|placebo|placebo bid
16366096|NCT00125515|Drug|Memantine|One arm receives 30 mg bid and the other arm receives receives 15mg bid
16366097|NCT00125515|Drug|Naltrexone|Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
16366098|NCT00125502|Biological|CMV gB vaccine|CMV gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion, administered at 0, 1, and 6 months.
16366099|NCT00125502|Drug|MF59 adjuvant|Oil-in-water emulsion
16366100|NCT00125502|Drug|Placebo|Normal saline solution
16366101|NCT00125489|Drug|chloroquine sulfate|
16366102|NCT00125489|Drug|sulfadoxine/pyrimethamine|
16366103|NCT00125476|Behavioral|Exercise|
16366104|NCT00125463|Drug|Candesartan cilexetil|
16366105|NCT00125450|Procedure|Chest Physiotherapy with Forced Expiratory Technique|Chest Physiotherapy with Forced Expiratory Technique
16366106|NCT00125450|Procedure|Nasopharyngeal Aspiration|Nasopharyngeal Aspiration
16366107|NCT00125437|Drug|spironolactone|
16366108|NCT00125424|Drug|AQUAVAN® (fospropofol disodium) Injection|
16366109|NCT00125424|Drug|Midazolam HCl|
16366110|NCT00125411|Drug|satraplatin and docetaxel|"Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals.
~Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush."
16366111|NCT00125398|Drug|AQUAVAN (fospropofol disodium; GPI 15715 )|
16366112|NCT00125385|Biological|GC1008|0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
16366113|NCT00125385|Biological|GC1008|1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
16366114|NCT00125385|Biological|GC1008|2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
16366115|NCT00125385|Biological|GC1008|4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
16366116|NCT00125385|Biological|GC1008|8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
16366117|NCT00125372|Drug|erlotinib (Tarceva) and bexarotene (Targretin)|Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
16366883|NCT00119392|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16366118|NCT00125359|Drug|erlotinib and bexarotene|Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
16366119|NCT00125346|Drug|Tobramycin Inhalation Powder|
16366120|NCT00125333|Drug|NF-kappaB Decoy|
16366121|NCT00125320|Drug|RSD1235|
16366122|NCT00125307|Drug|tacrolimus|
16366123|NCT00125294|Drug|Methadone|
16366124|NCT00125281|Drug|S-adenosyl-methionine (SAMe) capsules|
16366125|NCT00125268|Device|MIRE|Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.
16366126|NCT00125268|Device|Sham Device|The sham device is non-active but otherwise identical to the study device.
16366127|NCT00125255|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel comprising of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. The study drug was applied at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
16366128|NCT00125255|Drug|Placebo Peel|Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 30 minutes
16366129|NCT00125242|Behavioral|Semantic Feature Analysis (SFA)Training|SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, action associated with item). For some participants, treatment items were grouped according to typicality of category membership (e.g,, a robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in the context of single-subject, multiple baseline designs. In this way, replication of treatment effects could be evaluated within and across participants. Treatment was administered by certified SLPs three times per week until prescribed accuracy levels were met during nontreatment probes or a maximum number of treatment sessions was completed.
16366130|NCT00125229|Drug|Mannitol|
16366131|NCT00125229|Drug|Hypertonic Saline|
16366132|NCT00125216|Behavioral|Response Elaboration Training|Therapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures
16366133|NCT00125203|Drug|Botulinum toxin type B (Myobloc)|
16366134|NCT00125203|Procedure|Injection of salivary glands|
16366135|NCT00125190|Drug|rhIGF-1 (mecasermin) for a period of 86 weeks|Once a day rhIGF-1 injections
16366136|NCT00125177|Behavioral|Knack therapy|
16366137|NCT00125164|Drug|rhIGF-1 (mecasermin, Tercica, Inc.)|Twice Daily Injection
16366138|NCT00125151|Drug|C1 inhibitor concentrate (C1-esteraseremmer-N)|
16366139|NCT00125138|Drug|Melperone HCl|20 mg/day. Strength of melperone syrup is 5 mg/mL
16366140|NCT00125138|Drug|Melperone HCl|40 mg/day. Strength of melperone syrup is 5 mg/mL
16366141|NCT00125138|Drug|Melperone HCl|60 mg/day. Strength of melperone syrup is 5 mg/mL
16366142|NCT00125138|Drug|Placebo|Syrup formulation
16366143|NCT00125125|Drug|Fluvastatin|
16366144|NCT00125112|Behavioral|Internet-based intervention designed to reduce binge eating and improve healthy weight regulation|
16366145|NCT00125099|Biological|VRC-HIVDNA009-00-VP|
16366146|NCT00125086|Device|autologous platelet gel|
16366147|NCT00125073|Behavioral|Postoperative nutritional counseling|
16366148|NCT00125060|Drug|Simvastatin (20mg versus 80mg/day)|
16366149|NCT00125047|Biological|Typhoid Vi vaccine|Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
16366150|NCT00125047|Biological|Hepatitis A vaccine|single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
16366151|NCT00125034|Biological|Cetuximab|"Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
~Until progression or unacceptable toxicity develops"
16366152|NCT00125034|Drug|Oxaliplatin|"Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
~Until progression or unacceptable toxicity develops"
16366153|NCT00125021|Drug|Capecitabine|Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
16366154|NCT00125021|Drug|OSI-774|Given once daily
16366155|NCT00125008|Biological|Typhoid Vi vaccine|single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)
16366156|NCT00125008|Biological|Hepatitis A vaccine|720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults
16366157|NCT00124995|Drug|terbutaline|
16366158|NCT00124982|Drug|Abatacept|IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
16366159|NCT00124982|Drug|Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)|During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
16366160|NCT00124982|Drug|Anti-Tumor Necrosing Factor (TNF) Therapy|Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
16366161|NCT00124969|Drug|Amlodipine|10mg
16366162|NCT00124969|Drug|Placebo|10mg
16366163|NCT00124956|Drug|Doxorubicin|
16366164|NCT00124943|Drug|Nanoparticle Paclitaxel|Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
16366165|NCT00124930|Drug|Olanzapine|
16366166|NCT00124930|Drug|Haldol|
16366601|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
16366167|NCT00124917|Radiation|Radiation|Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 centigray (cGy) in 180 cGy daily fractions.[1]
16366168|NCT00124904|Behavioral|Biofeedback|
16366169|NCT00124904|Behavioral|Kegel exercises|
16366170|NCT00124891|Drug|Double-blind investigational anti-arrhythmic|
16366171|NCT00124891|Drug|GAP-486|
16366172|NCT00124878|Procedure|Male circumcision|Sleeve circumcision
16366173|NCT00124865|Biological|rFla-MBP|
16366174|NCT00124852|Behavioral|n-3 Fatty Acid Supplementation|
16366175|NCT00124839|Drug|Naltrexone|Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone
16366176|NCT00124826|Drug|Insulin|
16366177|NCT00124813|Drug|thalidomide|
16366178|NCT00124813|Drug|idarubicin|oral idarubicin
16366179|NCT00124800|Behavioral|Tinnitus retraining therapy|Sound therapy and counseling
16366180|NCT00124800|Device|Sound therapy|sound therapy and counselling
16366181|NCT00124787|Drug|Dimenhydrinate|Dimenhydrinate PO q 6 hours x 4 doses
16366182|NCT00124787|Drug|Placebo|Placebo PO q 6 hours x 4 doses
16366183|NCT00124774|Procedure|Nucleoplasty|
16366184|NCT00124761|Procedure|Surgery + WBRT|Surgery - complete excision of Solitary Brain Metastasis with 30 Gy in 10 fractions over 2 2 1/2 weeks
16366185|NCT00124761|Radiation|Radiosurgery + WBRT|Radiosurgery - Marginal dose based on maximum tumour diameter
16366186|NCT00124748|Drug|Imatinib mesylate|Imatinib is packaged in bottles as 100mg and 400mg tablets
16366187|NCT00124735|Drug|Rocuronium bolus maintenance|Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
16366188|NCT00124735|Drug|rocuronium continuous infusion maintenance|Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
16366189|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
16366190|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
16366191|NCT00124722|Drug|Rocuronium bromide (Zemuron)|A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
16366192|NCT00124709|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16366193|NCT00124709|Drug|Corticosteroid|conventional corticosteroid-based treatment
16366194|NCT00124696|Drug|Cocaethylene|
16366195|NCT00124683|Drug|Bupropion|
16366196|NCT00124683|Drug|nicotine transdermal patch|
16366197|NCT00124657|Drug|Erlotinib hydrochloride|This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).
16366198|NCT00124644|Drug|cytarabine|
16366199|NCT00124644|Drug|daunorubicin hydrochloride|
16366200|NCT00124644|Drug|etoposide|
16366201|NCT00124644|Drug|tipifarnib|
16366202|NCT00124644|Procedure|chemotherapy|
16366203|NCT00124644|Procedure|enzyme inhibitor therapy|
16366204|NCT00124644|Procedure|high-dose chemotherapy|
16366205|NCT00124618|Biological|cetuximab|
16366206|NCT00124618|Radiation|radiation therapy|
16366207|NCT00124605|Drug|pamidronate disodium|Given IV
16366208|NCT00124605|Drug|arsenic trioxide|Given IV
16366209|NCT00124605|Other|laboratory biomarker analysis|Correlative studies
16366210|NCT00124605|Other|pharmacological study|Correlative studies
16366211|NCT00124579|Drug|bortezomib|induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days
16366212|NCT00124579|Drug|dexamethasone|induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression
16366213|NCT00124579|Drug|thalidomide|100 mg/d PO days 1-21 every 21 days
16366214|NCT00124566|Drug|Irofulven|Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.
16366215|NCT00124566|Drug|Prednisone|Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
16366216|NCT00124566|Drug|Mitoxantrone|Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m^2 per day, once every 3 weeks.
16366217|NCT00124566|Drug|Capecitabine|Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
16366218|NCT00124566|Drug|Irofulven|Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.
16366219|NCT00124553|Behavioral|Intensive dietary advice|
16366220|NCT00124540|Drug|misoprostol|
16366221|NCT00124540|Drug|placebo|placebo resembling misoprosotl
16366222|NCT00124527|Drug|Irofulven + capecitabine|
16366223|NCT00124514|Drug|Triptorelin pamoate|IM injection given monthly
16366224|NCT00124514|Drug|Triptorelin Pamoate|IM injection given monthly
16366225|NCT00124514|Drug|Triptorelin Pamoate|IM injection given monthly
16366226|NCT00124514|Drug|Triptorelin Pamoate|IM injection given monthly
16366227|NCT00124514|Other|placebo|placebo 0.9% normal saline IM injection
16366228|NCT00124501|Behavioral|Biofeedback-assisted relaxation training|10 sessions BART
16366229|NCT00124488|Device|Tomotherapy Treatment Planning|
16366230|NCT00124475|Drug|alitretinoin|
16366231|NCT00124462|Device|Realigning knee brace and custom orthodic|A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
16366232|NCT00124462|Device|Non realigning knee brace and flat orthodic|A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
16366233|NCT00124449|Drug|Abatacept|"solution, intravenous injection, monthly, 169 days
~weight based:
~<60 kg = 500 mg
~60 to 100 kg = 750 mg
~>100 kg = 1 g"
16366234|NCT00124449|Drug|placebo|solution, intravenous injection, 0 mg, monthly, 169 days
16366235|NCT00124436|Drug|alitretinoin|
16366236|NCT00124423|Procedure|Megavoltage CT scan|
16366237|NCT00124397|Drug|Atorvastatin|
16366238|NCT00124384|Behavioral|CBT-I|
16366239|NCT00124384|Drug|modafinil|
16366240|NCT00124371|Behavioral|a nurse led home-based education and support programme|
16366241|NCT00124358|Drug|Buprenorphine|
16366242|NCT00124358|Behavioral|Integrated HIV care and office-based opioid dependence treatment|
16366243|NCT00124345|Device|MR730|humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort
16366244|NCT00124332|Drug|Rimonabant (SR141716)|
16366245|NCT00124332|Drug|Placebo|
16366246|NCT00124306|Drug|Amitriptyline|Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet.
16366247|NCT00124306|Other|Placebo|Placebo will be dosed exactly as active arm.
16366248|NCT00124293|Drug|activated recombinant human factor VII|
16366249|NCT00124280|Drug|RAD001|
16366250|NCT00124267|Drug|Intrarectal quinine|
16366251|NCT00124254|Procedure|Silicone metacarpophalangeal joint arthroplasty|Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
16366252|NCT00124254|Other|Usual care|Non-surgical usual care
16366253|NCT00124241|Drug|telbivudine|
16366254|NCT00124241|Drug|lamivudine|
16366255|NCT00124228|Drug|Human Albumin|albumin 1.5g/kg body weight the first day of inclusion plus 1g/kg/body weight the 3th day of inclusion.
16366256|NCT00124215|Biological|GI-5005|Heat-killed yeast cell transfected with NS3-Core fusion protien.
16366257|NCT00124202|Behavioral|a fatty meal|Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
16366258|NCT00124189|Drug|GRN163L|Weekly intravenous infusion
16366259|NCT00124176|Drug|Racemic albuterol (R+S albuterol)|20mg/hr continuous racemic albuterol
16366260|NCT00124176|Drug|Levalbuterol (R albuterol)|10mg/hr continuous nebulized levalbuterol
16366261|NCT00124163|Procedure|Imaging procedure of CT colonography|
16366262|NCT00124150|Drug|Intravenous magnesium sulfate infusion|80mg per day
16366263|NCT00124137|Device|Aquadex system|
16366264|NCT00124137|Drug|IV diuretic|
16366265|NCT00124124|Drug|KLH; Peptides; Dendritic Cells|Upon entry into the study, patients randomized to the dendritic cell arm will undergo a complete baseline evaluation and leukapheresis 0.5 to 3 x 106 DCs per peptide antigen (total not to exceed 18 x 106 cells) will be administered intradermally as per injection SOP. They will receive up to 3 booster DC injections (total not to exceed 18 x 10 6 cells per injection) at monthly intervals for a total of 4 injections. The booster injections will not contain KLH, as our volunteer studies have shown that priming occurs following a single injection of DCs
16366266|NCT00124124|Drug|KLH, peptides plus Montanide|Patients randomized to the Montanide arm will also undergo complete baseline evaluation but not leukapheresis. The peptides will be mixed with the adjuvant, Montanide, and administered subcutaneously at a dose of 100 microgram of each peptide +100 microgram KLH mixed with an equal volume of Montanide. They will receive up to 3 booster injections at monthly intervals for a total of 4 injections. The booster injections will not contain KLH.
16366267|NCT00124111|Drug|pegfilgrastim|
16366268|NCT00124111|Drug|cyclophosphamide|
16366269|NCT00124111|Drug|methotrexate|
16366270|NCT00124111|Drug|5-fluorouracil|
16366271|NCT00124098|Drug|Aranesp® (darbepoetin alfa)|
16366272|NCT00124085|Behavioral|Disease Management|
16366273|NCT00124085|Behavioral|Disease Management + Educational Home Visits|
16366274|NCT00124072|Drug|Simvastatin 20 mg daily|Simvastatin 20 mg tablet once daily
16366275|NCT00124072|Dietary Supplement|Folic acid 2 mg + vitamin B12 1 mg daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily
16366276|NCT00124072|Drug|Simvastatin 80 mg daily|Simvastatin 80 mg tablet once daily
16366277|NCT00124072|Drug|Placebo|Placebo vitamin B12/folic acid tablet once daily
16366278|NCT00124059|Drug|Seroquel|400mg/day quetiapine
16366279|NCT00124059|Drug|Placebo|400mg/day placebo
16366280|NCT00124046|Procedure|Surgery|Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two
16366281|NCT00124046|Procedure|Medical Treatment|Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two
16366282|NCT00124033|Procedure|Transcystic Stenting (Facilitated ERCP)|
16366283|NCT00124020|Drug|Telavancin|Telavancin 10 mg/kg/day IV for up to 21 days
16366284|NCT00124020|Drug|Vancomycin|Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
16366285|NCT00124007|Biological|VRC-HIVADV014-00-VP|
16366286|NCT00124007|Biological|VRC-HIVDNA016-00-VP|
16366287|NCT00123994|Behavioral|Tai Chi classes|
16366288|NCT00123994|Behavioral|Hydrotherapy classes|
16366289|NCT00123981|Procedure|Off-Pump Coronary Artery Bypass Grafting|
16366290|NCT00123968|Biological|VRC-HIVDNA016-00-VP|1x10^11 per unit vaccine administered intramuscularly via Bioinjector
16366291|NCT00123968|Biological|VRC-HIVADV014-00-VP|4 mg administered intramuscularly via injection
16366292|NCT00123968|Biological|VRC-DILUENT013-DIL-VP|Administered intramuscularly via Bioinjector
16366293|NCT00123968|Biological|VRC-HIVADV014-00-VP placebo|4 mg administered intramuscularly via injection
16366294|NCT00123955|Drug|Spironolactone|25mg tablet daily for 9 months
16366295|NCT00123955|Drug|Placebo|Placebo tablet daily for 9 months
16366296|NCT00123942|Drug|MEDI-507|
16366297|NCT00123929|Drug|docetaxel|100 mg/m2 every 3 weeks times 4
16366298|NCT00123929|Drug|doxorubicin|75 mg/m2 every 3 weeks times 4
16366299|NCT00123916|Drug|Benznidazole|Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
16366300|NCT00123916|Drug|Placebo|a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg)
16366301|NCT00123903|Drug|metoprolol xl|
16366302|NCT00123903|Drug|carvedilol MR|
16366303|NCT00123903|Drug|lisinopril|
16366304|NCT00123890|Drug|GW873140|
16366305|NCT00123877|Drug|GPX-100 (13-deoxydoxorubicin)|
16366306|NCT00123864|Procedure|Intensity-modulated radiation therapy|
16366307|NCT00123851|Drug|Tarceva (OSI-774)|
16366308|NCT00123851|Drug|Capecitabine|
16366309|NCT00123851|Drug|Oxaliplatin|
16366310|NCT00123838|Device|Calypso® 4D Localization System|Localization of prostate irradiation.
16366311|NCT00123825|Drug|Gemcitabine|
16366312|NCT00123825|Drug|Cisplatin|
16366313|NCT00123799|Procedure|Positron Emission Tomography Imaging|
16366314|NCT00123786|Procedure|Positron Emission Tomography|Positron Emission Tomography
16366315|NCT00123773|Procedure|Positron Emission Tomography|
16366316|NCT00123760|Procedure|Positron Emission Tomography (PET) scan|
16366317|NCT00123747|Procedure|Positron Emission Tomography (PET) scan Imaging|
16366318|NCT00123734|Drug|ThromboView|
16366319|NCT00123682|Procedure|Proactive outreach to counseling|Project staff reach out to engage referred smoker into telephone counseling
16366320|NCT00123682|Procedure|Reactive outreach to counseling|Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling
16366321|NCT00123682|Procedure|Intensive counseling|Multi-session telephone counseling, delivered by California Smokers' Helpline
16366322|NCT00123682|Procedure|Self-help|Project staff send out self-help materials for smoking cessation
16366323|NCT00123669|Drug|500 mg of depot hydroxy-progesterone|An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
16366324|NCT00123656|Drug|esomeprazole|esomeprazole dosed qam for 8 weeks
16366325|NCT00123656|Drug|fluticasone|fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
16366326|NCT00123643|Drug|rosiglitazone|
16366327|NCT00123643|Drug|glyburide|
16366328|NCT00123630|Drug|omalizumab|omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
16366329|NCT00123630|Drug|Placebo|Placebo given IV once every 2-4 weeks based on weight
16366330|NCT00123617|Procedure|Phase III group-based cardiac rehabilitation|Phase III group-based cardiac rehabilitation
16366331|NCT00123604|Drug|Carvedilol|25 mg twice daily for five months.
16366332|NCT00123604|Drug|Metoprolol|200 mg twice daily for five months.
16366333|NCT00123591|Drug|activated recombinant human factor VII|
16366334|NCT00123578|Drug|Lorazepam|Lorazepam
16366335|NCT00123578|Drug|Pentobarbital|Pentobarbital
16366336|NCT00123565|Drug|Hexadecasaccharide (SR123781A)|
16366337|NCT00123552|Drug|Amodiaquine+Artesunate|Amodiaquine 10 mg/kg on day 1, then 5 mg/kg on day 2 and 3; Artesunate 4 mg/kg/d for three days
16366338|NCT00123552|Drug|Amodiaquine+Sulfadoxine/Pyrimethamine|Amodiaquine 10 mg/kg on day 1, then 5 mg/kg on day 2 and 3; S/P at 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine single dose
16366339|NCT00123552|Drug|Artemether+Lumefantrine|Artemether 20 mg + Lumefantrine 120 mg 6 dose regimen at 0 and 8 hours on day 1 and twice daily on days 2 and 3:5 kg to < 15 kg: 1 tab/dose; 15 to 24 kg: 2 tabs/dose; >35 kg:4 tabs per dose
16366340|NCT00123539|Drug|Estrogen Replacement Therapy|
16366341|NCT00123539|Procedure|Surgery|
16366342|NCT00123526|Behavioral|Diet|Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.
16366343|NCT00123526|Behavioral|Physical Activity|The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.
16366344|NCT00123513|Behavioral|Diet|Environmental changes in the food and physical activity environment. Cafeteria and vending machine changes, food brought from home, walking routes, and awareness building.
16366345|NCT00123513|Behavioral|Exercise|Increase routing physical activity, walking routes, stairs intervention, etc.
16366346|NCT00123513|Behavioral|Environment|Cafeteria and vending machine changes and identification of opportunities of physical activity.
16366347|NCT00123500|Behavioral|Diet|Diet
16366348|NCT00123500|Behavioral|Physical Activity|Physical Activity
16366349|NCT00123500|Behavioral|Environment|Environment
16366350|NCT00123500|Other|Control Group|Control Group
16366351|NCT00123487|Drug|dasatinib|Tablets, Oral, 70 mg BID, indefinitely, survival study
16366352|NCT00123487|Drug|dasatinib|Tablets, Oral, 140 mg QD, indefinitely, survival study
16366353|NCT00123474|Drug|dasatinib|Tablets, Oral, 50 mg BID, indefinitely, survival study
16366354|NCT00123474|Drug|dasatinib|Tablets, Oral, 70 mg BID, indefinitely, survival study
16366355|NCT00123474|Drug|dasatinib|Tablets, Oral, 100 mg QD, indefinitely, survival study
16366356|NCT00123474|Drug|dasatinib|Tablets, Oral, 140 mg QD, indefinitely, survival study
16366357|NCT00123461|Drug|Hectorol (doxercalciferol capsules), 0.5mcg|
16366358|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
16366359|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
16366602|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
16366360|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
16366361|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
16366362|NCT00123435|Device|Simple pedometer|Device to be worn during waking hours to give an objective measure of steps taken each day.
16366363|NCT00123435|Behavioral|Nutritional counseling|The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
16366364|NCT00123435|Behavioral|Walking program|As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
16366365|NCT00123435|Device|Simple pedometer|Device to be worn during waking hours to give an objective measure of steps taken each day.
16366366|NCT00123435|Device|Enhanced pedometer|Simple pedometer with the addition of web-based feedback.
16366367|NCT00123422|Behavioral|Breathing retraining|exercise training with computerized training program
16366368|NCT00123422|Behavioral|Heliox|exercise training with a helium oxygen combination
16366369|NCT00123422|Behavioral|Exercise|exercise training
16366370|NCT00123409|Behavioral|Telephone disease management|Telephone based care management
16366371|NCT00123409|Behavioral|Usual Care|Usual care
16366372|NCT00123396|Behavioral|BioCASES and BioTESTS|
16366373|NCT00123383|Drug|Modafinil|
16366374|NCT00123370|Drug|Modafinil|
16366375|NCT00123344|Device|AT501 pacemaker|
16366376|NCT00123331|Drug|Cyclosporine discontinuation|
16366377|NCT00123331|Drug|Rapamycin medication|
16366378|NCT00123318|Drug|epirubicin|50mg/m2 IV day 1
16366379|NCT00123318|Drug|cisplatin|60mg/m2 IV day 1
16366380|NCT00123318|Drug|5-fluorouracil|5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
16366381|NCT00123318|Radiation|Radiotherapy|45Gy 25 Fractions, 5 days/week for 5 weeks
16366382|NCT00123305|Drug|Microplasmin|1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution.
16366383|NCT00123305|Drug|Microplasmin|1mg/kg bolus of placebo solution followed by 1,2 or 3mg/kg infusion of placebo solution
16366384|NCT00123292|Drug|Microplasmin|An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
16366385|NCT00123292|Drug|Microplasmin|An infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
16366386|NCT00123292|Drug|Microplasmin|An infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered.
16366387|NCT00123279|Drug|Microplasmin|25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
16366388|NCT00123266|Drug|Microplasmin|2 mg/kg, IA over 75 mins
16366389|NCT00123253|Drug|TH9507|
16366390|NCT00123240|Behavioral|Low calorie high carbohydrate diet|65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal
16366391|NCT00123240|Behavioral|Low calorie high fat/protein diet|High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal
16366392|NCT00123227|Drug|Rosiglitazone|
16366393|NCT00123214|Drug|Controlled Dietary Intervention|
16366394|NCT00123201|Drug|Dronabinol MDI|
16366395|NCT00123188|Procedure|Ultrasound and Biopsy|Transvaginal ultrasound and Endometrial Biopsy
16366396|NCT00123175|Device|Intrauterine Device|Mirena and Provera
16366397|NCT00123162|Drug|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
16366398|NCT00123162|Drug|Placebo|A single vaginal dose of placebo and monitored for 4 hours.
16366399|NCT00123149|Drug|Epoetin alfa|
16366400|NCT00123136|Device|foot energizer|
16366401|NCT00123123|Drug|chlorhexidine gluconate oral rinse (0.12%)|chlorhexidine gluconate oral rinse
16366402|NCT00123123|Drug|placebo|
16366403|NCT00123110|Drug|metformin|Initiated on 500 mg daily and titrated up to 1000 mg twice a day during the first four weeks, remaining at that dose until 12 weeks
16366404|NCT00123110|Drug|leuprolide injection|3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks)
16366405|NCT00123110|Drug|placebo pill|matching pill twice a day for 12 weeks
16366406|NCT00123110|Drug|placebo injection|matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)
16366407|NCT00123097|Combination Product|Chlorinated polyethylene elastomer|Chlorinated polyethylene
16366408|NCT00123084|Behavioral|Voice/Respiration Treatment|Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
16366409|NCT00123084|Behavioral|Speech/Articulation Treatment|Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
16366410|NCT00123058|Behavioral|Nurse administered|Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
16366411|NCT00123058|Device|BP Monitor|Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
16366412|NCT00123045|Behavioral|health education|
16366413|NCT00123032|Behavioral|Diet|Increase the availability of fruits and vegetables, serve recommended portion sizes and reduce availability of excessive energy-dense foods at school cafeterias to improve the diet of participants at school breakfast, lunch and snacks.
16366414|NCT00123032|Procedure|Exercise|Increase active recess time, implement classroom action breaks and increase school PE class time to increase physical activity among participants.
16366415|NCT00123019|Behavioral|Exercise and diet|Advice and measurement only
16366416|NCT00123019|Behavioral|Diet, Weight Reducing|Measurement, advice, environmental and behavioral group interventions
16366417|NCT00123019|Behavioral|Level 1|Annual assessment of weight and waist circumference, questionnaire on work, health issues, advice on diet, physical activity and other health issues.
16366418|NCT00123019|Behavioral|Level 2|All Level 1 activities plus ongoing environmental interventions in worksite and weight management groups in worksite over a 24 month period.
16366419|NCT00123006|Behavioral|Dietary Approaches to Stop Hypertension (DASH)|4 week feeding intervention
16366420|NCT00123006|Behavioral|Control Diet|4 week feeding intervention
16366421|NCT00122993|Behavioral|Healthful eating and food choices behavior change programs and changes in worksite food availability and prices|Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.
16366422|NCT00122993|Behavioral|Physical Activity|Physical activity programs are offered at the intervention garages for an 18 month period.
16366423|NCT00122993|Behavioral|Environment|Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.
16366424|NCT00122980|Procedure|Red Cell Transfusions|Red Blood Cell Transfusions
16366425|NCT00122980|Procedure|Iron Chelation|Iron Chelation Therapy
16366426|NCT00122980|Drug|Hydroxyurea|Hydroxyurea
16366427|NCT00122980|Procedure|Phlebotomy|Phlebotomy
16366428|NCT00122954|Drug|Fish oil concentrate|fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA).
16366429|NCT00122954|Drug|Placebo|soybean oil with 1% fish oil at a daily dose of 6 grams
16366430|NCT00122941|Dietary Supplement|multiple micronutrients|
16366431|NCT00122928|Behavioral|Diet|Healthy Choices in vending machines; Healthy Choices in cafeteria; Catering (Healthy Choices in site meetings, shutdowns, OT meals, etc.); Targeted Messages: Nutrition; Site Based Rewards and Recognition - Individual Employees Weight Management Tracking Program
16366432|NCT00122928|Behavioral|Exercise|Walking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees
16366433|NCT00122928|Behavioral|Environmental Obesity Program - Healthy Culture|Site Goal Setting; Work Group Alignment to Site Goals; Reporting to Senior Leadership; Leadership Training; Site Leadership, Cross Discipline Teams, Work Groups, Healthy Culture Focal Point Rewards and Recognition
16366434|NCT00122915|Device|Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator|
16366435|NCT00122889|Drug|Garlic powder with high allicin content|
16366436|NCT00122889|Drug|Garlic powder with low allicin content|
16366437|NCT00122889|Drug|Garlic oil|
16366438|NCT00122889|Drug|Aged garlic|
16366439|NCT00122876|Procedure|Photodynamic therapy|
16366440|NCT00122876|Drug|Talaporfin Sodium|
16366441|NCT00122863|Drug|Duloxetine Hydrochloride|
16366442|NCT00122863|Drug|placebo|
16366443|NCT00122850|Drug|Duloxetine|
16366444|NCT00122850|Drug|venlafaxine|
16366445|NCT00122850|Drug|placebo|
16366446|NCT00122837|Drug|Duloxetine|
16366447|NCT00122837|Drug|venlafaxine|
16366448|NCT00122837|Drug|placebo|
16366449|NCT00122824|Drug|duloxetine hydrochloride|
16366450|NCT00122824|Drug|placebo|
16366451|NCT00122811|Drug|Indapamide SR 1.5mg; Perindopril 2-4mg|
16366452|NCT00122798|Procedure|Stroke treatment|
16366453|NCT00122785|Drug|dexamethasone|
16366454|NCT00122772|Radiation|Radiotherapy|"External Beam Radiation 46Gy in 23 daily fractions
~High Dose Brachytherapy 2 fractions of 9Gy"
16366455|NCT00122772|Radiation|Radiotherapy|"External Beam Radiotherapy 46Gy in 23 daily fractions
~High Dose Brachytherapy 4 fractions of 7Gy"
16366456|NCT00122772|Radiation|Radiotherapy/Cisplatin|"External Beam Radiation 46Gy in 23 daily fractions
~High Dose Brachytherapy 2 fractions of 9Gy
~Cisplatin 40 mg/sqm weekly"
16366457|NCT00122772|Radiation|Radiotherapy/Cisplatin|"External Beam Radiotherapy 46Gy in 23 daily fractions
~High Dose Brachytherapy 4 fractions of 7Gy
~Cisplatin 40mg/sqm weekly"
16366458|NCT00122759|Drug|ketamine|
16366459|NCT00122746|Radiation|Radiotherapy alone|EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
16366460|NCT00122746|Radiation|Radiotherapy with cisplatin|EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT
16366461|NCT00122733|Drug|loxapine|
16366462|NCT00122720|Drug|Darbepoetin Alfa|
16366463|NCT00122707|Device|catheters|
16366464|NCT00122694|Drug|carbon monoxide|
16366465|NCT00122681|Biological|Cervarix™|Intramuscular injection, 3 doses
16366466|NCT00122681|Biological|Havrix™-based investigational formulation|Intramuscular injection, 3 doses
16366467|NCT00122668|Drug|non-nucleoside reverse transcriptase inhibitors|
16366468|NCT00122668|Drug|nucleoside reverse transcriptase inhibitors|
16366469|NCT00122668|Drug|protease inhibitor|
16366470|NCT00122655|Drug|non-nucleoside reverse transcriptase inhibitors|
16366471|NCT00122655|Drug|nucleoside reverse transcriptase inhibitors|
16366472|NCT00122655|Drug|protease inhibitors|
16366473|NCT00122642|Procedure|Alcohol-lock|The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
16366474|NCT00122642|Drug|placebo-lock|The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
16366475|NCT00122629|Drug|peg-interferon alfa-2b|
16366476|NCT00122629|Drug|ribavirin|
16366477|NCT00122629|Drug|amantadine|
16366478|NCT00122616|Biological|Peginterferon alpha-2a (Pegasys®)|Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly
16366479|NCT00122616|Drug|Ribavirin|Ribavirin: tablet oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over 75 kg, once daily
16366480|NCT00122616|Drug|HIV antiretroviral therapy|All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
16366481|NCT00122616|Drug|HIV antiretroviral therapy|All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
16366482|NCT00122603|Drug|Fosamprenavir|ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
16366483|NCT00122603|Drug|Saquinavir|ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)
16366484|NCT00122590|Drug|nelfinavir|
16366485|NCT00122590|Drug|lopinavir/r|
16366486|NCT00122590|Drug|indinavir|
16366487|NCT00122590|Drug|ritonavir|
16366488|NCT00122577|Drug|Tenofovir|
16366489|NCT00122577|Drug|Atazanavir|
16366490|NCT00122577|Drug|Ritonavir|
16366491|NCT00122564|Biological|HIV-1 gp 160|
16366492|NCT00122564|Biological|DC-Chol|
16366493|NCT00122551|Procedure|Intermittent antiretroviral therapy|
16366494|NCT00122538|Drug|Efavirenz (EFV)|
16366495|NCT00122538|Drug|Lamivudine (3TC)|
16366496|NCT00122538|Drug|Didanosine (ddI)|
16366497|NCT00122525|Procedure|Male Circumcision|
16366498|NCT00122512|Drug|Tenofovir Disoproxil Fumarate|
16366499|NCT00122499|Drug|tadalafil|
16366500|NCT00122486|Drug|Tenofovir Disoproxil Fumarate|
16366501|NCT00122473|Drug|Imatinib (Glivec)|
16366502|NCT00122460|Drug|Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
16366503|NCT00122460|Drug|Platinum (Cisplatin or Carboplatin) + 5-FU|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
16366504|NCT00122447|Drug|Aspirin|325 mg PO QD
16366505|NCT00122447|Drug|Alpha lipoic acid|600 mg PO BID
16366506|NCT00122447|Drug|Olmesartan|40 mg PO QD
16366507|NCT00122447|Drug|Placebo|"Identical placebo for each active comparator:
~placebo aspirin 325 mg PO QD; placebo for alpha lipoic acid 600 mg PO BID; placebo for olmesartan 40 mg PO QD"
16366508|NCT00122434|Drug|BEA 2180 BR|
16366509|NCT00122434|Drug|tiotropium|
16366510|NCT00122421|Behavioral|Pharmacist recommendations to primary care providers|recommendations based on chart review by pharmacist, given to pcp at time of visit
16366511|NCT00122421|Other|pharmacist recommendations|recommendations based on chart review by pharmacist, given to pcp at time of visit
16366512|NCT00122408|Dietary Supplement|Ergyphilus|5 pills a day of Ergyphilus or placebo
16366513|NCT00122395|Behavioral|Screening via pen and paper|
16366514|NCT00122395|Behavioral|Screening via audiotape|
16366515|NCT00122382|Drug|Abatacept|abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
16366516|NCT00122382|Drug|placebo|placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
16366517|NCT00122382|Drug|methotrexate|Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
16366518|NCT00122369|Behavioral|Self-hypnotic Relaxation|A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.
16366519|NCT00122369|Behavioral|Empathic Attention|A research assistant displayed defined behaviors of empathic attention.
16366520|NCT00122356|Drug|Alendronate sodium|70mg tablets, once weekly
16366521|NCT00122343|Drug|ridaforolimus|AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks. A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
16366522|NCT00122330|Drug|eculizumab|
16366523|NCT00122317|Drug|eculizumab|
16366524|NCT00122304|Drug|eculizumab|
16366525|NCT00122291|Drug|Capecitabine|
16366526|NCT00122291|Procedure|Pelvic radiation|
16366527|NCT00122278|Drug|Dexamethasone|Dexamethasone 10mg IV
16366528|NCT00122278|Other|Placebo|Placebo Dexamethasone 10mg IV
16366529|NCT00122226|Drug|Lopinavir/ritonavir + zidovudine + lamivudine|
16366530|NCT00122226|Drug|Lopinavir/ritonavir + nevirapine|
16366531|NCT00122213|Behavioral|Behavior change on physical activity and diet|
16366532|NCT00122187|Device|Electronic Consult System|Consult system is an event notification system programmed to function within the VA electronic medical record system.
16366533|NCT00122174|Behavioral|Stress Busting Program for family caregivers|
16366534|NCT00122161|Behavioral|ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers|
16366535|NCT00122161|Behavioral|Profiling performance|
16366536|NCT00122148|Behavioral|Feedback on provision of care|
16366537|NCT00122135|Other|Values Inventory (VI)|The Values Inventory was given to patients for self-administration while they were awaiting their clinic appointment. They were instructed to bring it to their physician's attention right at the beginning of their clinic visit.
16366538|NCT00122122|Behavioral|Enhanced Pharmacy Care|
16366539|NCT00122109|Behavioral|12 sessions Anger Management Therapy.|Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
16366540|NCT00122096|Drug|valdecoxib|
16366541|NCT00122083|Device|Health education information|
16366542|NCT00122070|Drug|Quetiapine Fumarate|Dosage can vary from 50 to 150 mg at PI's discretion
16366543|NCT00122057|Drug|antibiotic treatment|
16366544|NCT00122044|Drug|trihexyphenidyl|
16366545|NCT00122031|Device|Deep Brain Stimulation with Medtronic Activa Neurostimulator|Deep brain stimulation (DBS) at 130 Hz
16366546|NCT00122018|Drug|N-acetylcysteine|
16366547|NCT00122018|Drug|fenoldopam|
16366548|NCT00122005|Biological|GM-CSF gene transduced allogeneic vaccine GVAX|
16366549|NCT00121992|Drug|Docetaxel|
16366550|NCT00121992|Drug|5-fluorouracil|
16366551|NCT00121992|Drug|Doxorubicin|
16366552|NCT00121992|Drug|Cyclophosphamide|
16366553|NCT00121979|Drug|Racivir, a non-nucleoside reverse transcriptase inhibitor|
16366554|NCT00121966|Drug|Insulin Aspart|
16366555|NCT00121966|Drug|Insulin NPH|
16366556|NCT00121966|Drug|Metformin|
16366557|NCT00121966|Drug|Rosiglitazone|
16366558|NCT00121953|Drug|Rosiglitazone|
16366559|NCT00121940|Behavioral|Guided Care|"Specially trained registered nurse (Guided Care Nurse) based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; best practices for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources."
16366560|NCT00121927|Behavioral|Atkins diet (15 grams/day carbohydrates)|
16366561|NCT00121914|Procedure|percutaneous ethanol instillation (PEI)|
16366562|NCT00121901|Drug|glyceryl nitrate|
16366563|NCT00121888|Behavioral|Prolonged Exposure Therapy|
16366564|NCT00121888|Drug|Paroxetine-CR|
16366565|NCT00121875|Drug|somatropin (rDNA)|"Form/Strength: 10 mg aqueous suspension; 5 mg/ml
~Dosage/Frequency: 0.35 mg/kg/week, daily divided doses
~Duration: 6 months with 3-month washout period"
16366566|NCT00121862|Biological|Leish-111f + MPL-SE vaccine|
16366567|NCT00121849|Biological|Leish-111f + MPL-SE vaccine|
16366568|NCT00121836|Drug|Capecitabine|1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
16366569|NCT00121836|Drug|Bevacizumab|15 mg IV on Day 1 of each 3-week cycle
16366570|NCT00121823|Biological|FP9 ME-TRAP|
16366571|NCT00121823|Biological|MVA ME-TRAP|
16366572|NCT00121810|Drug|mycophenolate mofetil [CellCept]|1.0-1.5 g oral dose twice daily
16366573|NCT00121810|Drug|Corticosteroids|As prescribed
16366574|NCT00121810|Drug|Calcineurin inhibitors|As prescribed
16366575|NCT00121810|Drug|Sirolimus|As prescribed
16366576|NCT00121797|Procedure|urine culture|
16366577|NCT00121797|Drug|antibiotics according to culture|
16366578|NCT00121784|Drug|mycophenolate mofetil [CellCept]|1
16366579|NCT00121771|Biological|FP9 CS|
16366580|NCT00121771|Biological|MVA CS|
16366581|NCT00121758|Biological|LIPO-5|
16366582|NCT00121745|Genetic|Rexin-G Dose 1|Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose I 3- 6 Days 1-7, 15-21 7.5 x 10e9 cfu 500 ml
16366583|NCT00121745|Genetic|Rexin-G Dose 2|Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose II 3- 6 Days 1-7, 15-21 1.1 x 10e10 cfu 500 ml
16366584|NCT00121745|Genetic|Rexin-G Dose 3|"Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
~III 3- 6 5 days/wk x 4 wks 3.0 x 10e10 cfu 500 ml"
16366585|NCT00121745|Genetic|Rexin-G Dose 4|"Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
~IV 3- 6 5 days/wk x 4 wks 8.0 x 10e10 cfu 500 ml"
16366586|NCT00121732|Drug|E7974|Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle.
16366587|NCT00121732|Drug|E7974|Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle.
16366588|NCT00121719|Drug|Lenvatinib|Lenvatinib tablets taken orally, once daily.
16366589|NCT00121706|Behavioral|Condition A (see detailed summary)|
16366590|NCT00121706|Behavioral|Condition B (see detailed summary)|
16366591|NCT00121706|Behavioral|Condition C (see detailed summary)|
16366592|NCT00121693|Behavioral|Music therapy (listening to specific music)|Listening to Music
16366593|NCT00121680|Drug|E7080|Oral.
16366594|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
16366595|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
16366596|NCT00121667|Drug|Saxagliptin + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
16366597|NCT00121667|Drug|Placebo + Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
16366598|NCT00121667|Drug|Pioglitazone|Tablets, Oral, 15 - 45 mg (as needed for rescue)
16366599|NCT00121654|Device|Spinal cord stimulation|Under sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling.
16366600|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])
16366603|NCT00121641|Drug|Placebo matching Saxagliptin|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
16366604|NCT00121641|Drug|Metformin|Tablets, Oral, 500 mg, daily (42 months LT)
16366605|NCT00121641|Drug|Placebo matching Metformin|Tablets, Oral, 0 mg, daily (42 months LT)
16366606|NCT00121641|Drug|Saxagliptin|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
16366607|NCT00121641|Drug|Metformin|Tablets, Oral, 500-2000 mg (as needed for rescue)
16366608|NCT00121628|Drug|AMG 706|
16366609|NCT00121615|Drug|etanercept|
16366610|NCT00121602|Drug|Darbepoetin Alfa|Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
16366611|NCT00121589|Drug|Lutein|
16366612|NCT00121563|Drug|Thalidomide, Ibuprofen or Diazepam|
16366613|NCT00121550|Drug|clarithromycin|
16366614|NCT00121537|Device|Wound Care -Wound Vacuum Assisted Closure (VAC)|
16366615|NCT00121537|Procedure|Wound Care - Wet to Dry Dressing Changes|
16366616|NCT00121524|Drug|Epinephrine|Epinephrine 1 mg is given iv. every 3 min during CPR
16366617|NCT00121524|Device|Intravenous needle|An intravenous needle in placed as soon as possible during CPR
16366618|NCT00121524|Drug|Atropine|Atropine 3 mg iv in initial systole
16366619|NCT00121524|Drug|Amiodarone|amiodarone 300 mg iv after repeated failed defibrillation attempts
16366620|NCT00121511|Drug|Efudex (5-fluorouracil)|
16366621|NCT00121498|Drug|Lidocaine (local anesthetics) 20 ml of 1 % subcutaneously|
16366622|NCT00121485|Device|Left Ventricular Assist System (LVAS)|Implantation of left ventricular assist device for hemodynamic support
16366623|NCT00121472|Device|Thoratec HeartMate II Left Ventricular Assist System (LVAS)|Implantation of ventricular assist device to provide hemodynamic support
16366624|NCT00121459|Device|Ortho All-Flex diaphragm and Replens lubricant gel|
16366625|NCT00121446|Drug|tenecteplase|
16366626|NCT00121446|Drug|enoxaparin|
16366627|NCT00121446|Drug|clopidogrel|
16366628|NCT00121446|Procedure|percutaneous coronary intervention|
16366629|NCT00121433|Drug|leptin|
16366630|NCT00121420|Drug|Motexafin gadolinium|
16366631|NCT00121407|Drug|Visudyne for injection|
16366632|NCT00121394|Procedure|Chlorhexidine vaginal and infant wash|
16366633|NCT00121381|Drug|Pimecrolimus plus topical corticosteroid (TCS)|Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
16366634|NCT00121381|Drug|Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)|twice daily administration
16366635|NCT00121355|Device|safety glide|
16366636|NCT00121355|Device|autocover needle|
16366637|NCT00121329|Drug|Intrauterine lidocaine infusion 4%|
16366638|NCT00121316|Drug|Pimecrolimus|Pimecrolimus Cream 1 %
16366639|NCT00121316|Drug|Placebo|Vehicle cream (placebo cream)
16366640|NCT00121303|Drug|cytarabine|
16366641|NCT00121303|Drug|daunorubicin hydrochloride|
16366642|NCT00121303|Drug|gemtuzumab ozogamicin|
16366643|NCT00121290|Drug|SJG-136|Given IV
16366644|NCT00121290|Other|laboratory biomarker analysis|Correlative studies
16366645|NCT00121290|Other|pharmacological study|Correlative studies
16366646|NCT00121277|Drug|capecitabine|
16366647|NCT00121277|Drug|vorinostat|
16366648|NCT00121264|Drug|sorafenib tosylate|Given orally
16366649|NCT00121264|Drug|tanespimycin|Given IV
16366650|NCT00121264|Other|laboratory biomarker analysis|Correlative studies
16366651|NCT00121264|Other|pharmacological study|Correlative studies
16366652|NCT00121264|Procedure|magnetic resonance imaging|Correlative studies
16366653|NCT00121251|Drug|Capecitabine|Given PO
16366654|NCT00121251|Drug|Gemcitabine Hydrochloride|Given IV
16366655|NCT00121251|Drug|Sorafenib Tosylate|Given PO
16366656|NCT00121238|Drug|cilengitide|Given IV
16366657|NCT00121225|Drug|vorinostat|Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
16366658|NCT00121212|Procedure|carbon-11 acetate PET scan|
16366659|NCT00121199|Biological|rituximab|Given IV
16366660|NCT00121199|Biological|bevacizumab|Given IV
16366661|NCT00121199|Drug|cyclophosphamide|Given IV
16366662|NCT00121199|Drug|doxorubicin hydrochloride|Given IV
16366663|NCT00121199|Drug|vincristine sulfate|Given IV
16366664|NCT00121199|Drug|prednisone|Given PO
16366665|NCT00121199|Other|laboratory biomarker analysis|Correlative studies
16366666|NCT00121186|Drug|fludarabine phosphate|30 mg/m^2 on days -6 to -2 (2-6 days before transplant).
16366667|NCT00121186|Drug|melphalan|70 mg/m^2 on days -3 and -2 (2-3 days before transplant).
16366668|NCT00121186|Drug|methotrexate|5 mg/m^2 on days 1, 3, and 7 post-transplant.
16366669|NCT00121186|Drug|tacrolimus|0.03 mg/kg bid on days -3 to 100 post-transplant.
16366670|NCT00121186|Procedure|allogeneic bone marrow transplantation|if donor bone marrow stem cells are harvested
16366671|NCT00121186|Procedure|peripheral blood stem cell transplantation|if donor peripheral blood stem cells are harvested
16366672|NCT00121173|Biological|pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine|recombinant DNA vaccine
16366741|NCT00120601|Drug|Acamprosate|
16366742|NCT00120588|Drug|magnesium|
16366743|NCT00120575|Procedure|hemofiltration|
16366744|NCT00120562|Procedure|Gastric Bypass Surgery|
16366745|NCT00120549|Procedure|Assisted embryo hatching|
16366746|NCT00120536|Drug|vildagliptin|
16366747|NCT00120523|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16366748|NCT00120523|Drug|Topical corticosteroids|TCS
16366749|NCT00120510|Drug|Efavirenz|Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime
16366673|NCT00121160|Behavioral|Cognitive Behavioral Stress Management (CBSM) group intervention|Participants will meet in closed, structured groups of 4 to 6 women for ten weekly, 2-hour group sessions. The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Group members and group leaders are used as role models for effective coping and the use of social support. The groups also encourage emotional expression and provide an opportunity to practice techniques learned in the group and experience social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Each week participants also experience a different relaxation technique. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
16366674|NCT00121147|Drug|Travatan|
16366675|NCT00121147|Drug|Azopt|
16366676|NCT00121147|Drug|Alphagan P|
16366677|NCT00121134|Drug|Bevacizumab|Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months
16366678|NCT00121134|Drug|Cyclophosphamide|Once a day for 6 months
16366679|NCT00121134|Drug|Methotrexate|Twice daily for the first two days of every week for 6 months
16366680|NCT00121134|Drug|Capecitabine|"Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks)
~Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)"
16366681|NCT00121121|Biological|Lipopeptides LIPO-4|
16366682|NCT00121108|Biological|MEDI-524|15 mg/kg motavizumab administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season
16366683|NCT00121108|Other|Placebo|15 mg/kg placebo administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.
16366684|NCT00121095|Drug|Samarium Sm-153 lexidronam + Docetaxel|1 mCi/kg Sm153 + 75 mg/m2 docetaxel
16366685|NCT00121069|Drug|Escitalopram|
16366686|NCT00121056|Drug|Enbrel®|
16366687|NCT00121056|Drug|Kineret®|
16366688|NCT00121043|Device|SimpleJectTM|
16366689|NCT00121043|Drug|Kineret® (Anakinra)|
16366690|NCT00121030|Drug|darbepoetin alfa|
16366691|NCT00121030|Drug|recombinant human erythropoietin (rHuEPO)|
16366692|NCT00121017|Drug|Kaletra (lopinavir/ritonavir)|
16366693|NCT00121017|Drug|Sustiva (efavirenz)|
16366694|NCT00121017|Drug|Truvada (emtricitabine/tenofovir disoproxil fumarate)|
16366695|NCT00121004|Behavioral|Advance Directive Selection|
16366696|NCT00120991|Procedure|Coronary artery bypass grafting|
16366697|NCT00120978|Drug|Advair|
16366698|NCT00120978|Drug|Flovent|
16366699|NCT00120965|Device|AutoPulse|Standard device settings
16366700|NCT00120965|Other|Manual CPR|Manual CPR
16366701|NCT00120952|Device|Bi-Metric femoral implant (titanium versus cobalt-chromium)|
16366702|NCT00120939|Drug|Motexafin Gadolinium|
16366703|NCT00120926|Drug|Parenteral Nutrition|
16366704|NCT00120913|Drug|Birth control pills|
16366705|NCT00120900|Drug|GW406381|
16366706|NCT00120887|Drug|Atorvastatin|
16366707|NCT00120874|Behavioral|Individualized management of AD including caregiver training|Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.
16366708|NCT00120874|Drug|Memantine|Patients receive 10 milligrams of memantine twice daily.
16366709|NCT00120861|Drug|valopicitabine|
16366710|NCT00120861|Drug|pegylated interferon|
16366711|NCT00120861|Drug|ribavirin|
16366712|NCT00120848|Biological|HPV 16/18 VLP AS04|
16366713|NCT00120835|Drug|valopicitabine|
16366714|NCT00120835|Drug|pegylated interferon|
16366715|NCT00120822|Drug|Folic acid|
16366716|NCT00120809|Drug|Sulfadoxine-pyrimethamine|
16366717|NCT00120796|Drug|Lamivudine|
16366718|NCT00120796|Biological|Recombinant hepatitis B surface antigen|
16366719|NCT00120783|Drug|Indinavir|
16366720|NCT00120783|Drug|Lamivudine|
16366721|NCT00120783|Drug|Ritonavir|
16366722|NCT00120770|Drug|Cellulose Sulfate Vaginal Gel (Microbicide)|
16366723|NCT00120757|Drug|Alendronate|
16366724|NCT00120744|Drug|Ondansetron Oral Disintegrating Tablet|
16366725|NCT00120731|Drug|Potassium Citrate|
16366726|NCT00120731|Drug|Acetazolamide|
16366727|NCT00120731|Behavioral|Diet low in oxalate and purines|
16366728|NCT00120718|Drug|fasudil|
16366729|NCT00120705|Drug|darbepoetin alfa|
16366730|NCT00120692|Drug|Darbepoetin Alfa|
16366731|NCT00120692|Drug|Recombinant Human Erythropoietin|
16366732|NCT00120679|Drug|darbepoetin alfa|
16366733|NCT00120679|Drug|recombinant human erythropoietin (rHuEPO)|
16366734|NCT00120653|Drug|Metoclopramide|
16366735|NCT00120640|Drug|17 hydroxyprogesterone caproate intramuscular injections|
16366736|NCT00120627|Behavioral|Mantram Repetition Program (MRP) plus Usual Care|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
16366737|NCT00120627|Other|Usual care consisting of medication and case management|Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
16366738|NCT00120614|Behavioral|Premature infant behavior and development information|
16366739|NCT00120614|Behavioral|Parental activities to support premature infant information|
16366740|NCT00120601|Drug|Naltrexone|
16366750|NCT00120510|Drug|Lamivudine/Zidovudine|Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours
16366751|NCT00120497|Drug|somatropin (rDNA)|"Dosage form/strength: 13.8 mg powder in 2-chamber cartridge; reconstitutes to 10 mg/ml
~Dosage regimen: 0.48 mg/kg/week
~Route/rate of administration: subcutaneous injection, daily dose"
16366752|NCT00120484|Drug|Vitamin B12|
16366753|NCT00120471|Drug|Tenofovir disoproxil fumarate|600-mg tablet taken orally once daily
16366754|NCT00120471|Drug|Tenofovir disoproxil fumarate|4-mg/kg oral suspension taken at birth and on Days 3 and 5 after birth
16366755|NCT00120471|Drug|Tenofovir disoproxil fumarate|6-mg/kg oral suspension taken at birth and daily for 7 days after birth
16366756|NCT00120458|Dietary Supplement|Black cohosh|"32 to 128 mg (black cohosh)
~1 to 4 capsules daily (placebo)"
16366757|NCT00120445|Procedure|air|0.3 ml of filtered air
16366758|NCT00120445|Procedure|expansile gas|0.3 ml of perfluoropropane gas
16366759|NCT00120432|Drug|1% tropicamide and 10% phenylephrine|single dose vs three doses of 1%tropicamide and 10%phenylephrine
16366760|NCT00120419|Drug|mycophenol mofetil (MMF, Cellcept®) 500 mg BID|
16366761|NCT00120406|Device|Zilver® PTX™ Drug Eluting Vascular Stent|Stenting of the Superfemoropopliteal Artery
16366762|NCT00120406|Procedure|Angioplasty|Angioplasty of the Superfemoropopliteal Artery
16366763|NCT00120393|Drug|atazanavir/ritonavir +2 NRTIs (immediate Switch Group)|Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
16366764|NCT00120393|Drug|LPV/r +2 NRTIs (Delayed/optional Switch Group)|Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
16366765|NCT00120380|Drug|Aerosolized iloprost|
16366766|NCT00120380|Drug|Placebo|
16366767|NCT00120367|Drug|Enfuvirtide|
16366768|NCT00120367|Drug|Tenofovir-Emtricitabine|
16366769|NCT00120354|Procedure|Blood Testing|
16366770|NCT00120354|Procedure|Percutaneous Liver Biopsy|
16366771|NCT00120354|Procedure|Lamivudine Therapy|
16366772|NCT00120341|Device|Anodyne Therapy System|
16366773|NCT00120328|Drug|SPP301|
16366774|NCT00120315|Drug|esomeprazole|esomeprazole, original Nexium, 40 mg pills Up to once a day
16366775|NCT00120315|Procedure|Helicobacter pylori c-13 breath test|Breath test done at entry to find Helicobacter pylori
16366776|NCT00120302|Drug|Pimecrolimus|Pimecrolimus cream 1 %
16366777|NCT00120302|Drug|Placebo|Matching vehicle cream
16366778|NCT00120289|Drug|Extended release niacin|2,000 mg/day or 1,500 mg/day if higher dose not tolerated
16366779|NCT00120289|Drug|Simvastatin|Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
16366780|NCT00120276|Device|Less invasive mitral valve repair|
16366781|NCT00120263|Procedure|Plasma Exchange|
16366782|NCT00120250|Drug|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
16366783|NCT00120237|Drug|Misoprostol|600 mcg oral misoprostol administered during third stage of labor
16366784|NCT00120211|Radiation|Accelerated Radiotherapy Fractionation|Radiation Therapy 6 fractions per week
16366785|NCT00120211|Radiation|Accelerated Radiotherapy Fractionation|Radiotherapy 5 fractions per week
16366786|NCT00120198|Drug|CDOP plus rituximab|
16366787|NCT00120185|Drug|Interleukin-2|
16366788|NCT00120172|Drug|oxaliplatin, capecitabine, bevacizumab|
16366789|NCT00120133|Drug|Atorvastatin|
16366790|NCT00120120|Drug|Lenalidomide (CC-5013)|Lenalidomide 2-5 mg capsules taken one time per day
16366791|NCT00120107|Drug|Black Tea|
16366792|NCT00120081|Biological|Na-ASP-2/Alhydrogel Hookworm Vaccine|The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
16366793|NCT00120081|Biological|Saline placebo|Inactive saline placebo control
16366794|NCT00120068|Behavioral|Nursing inservices|
16366795|NCT00120068|Procedure|Academic detailing to MDs; concurrent review and feedback|
16366796|NCT00120055|Drug|Atorvastatin (Lipitor)|
16366797|NCT00120042|Drug|Misoprostol|600 mcg misoprostol swallowed after delivery of fetus
16366798|NCT00120042|Drug|Oxytocin|10 units oxytocin administered intramuscularly after delivery fetus
16366799|NCT00120029|Behavioral|weight loss counseling|
16366800|NCT00120016|Behavioral|dietary counseling|telephone counseling
16366801|NCT00120003|Drug|Candesartan Cilexetil|4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
16366802|NCT00120003|Drug|Placebo|4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
16366803|NCT00119990|Drug|Icodextrin (dialysate)|2 liter of extraneal are given with one fill for 4 hours.
16366804|NCT00119990|Drug|Physioneal (dialysate) 1.36% and 2.27%|2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.
16366805|NCT00119977|Procedure|1 Periacetabular osteotomy|pelvic osteotomy to increase acetabular coverage
16366806|NCT00119964|Behavioral|internet based weight management tools|
16366807|NCT00119951|Behavioral|Participation on the ACOR Listserv|
16366808|NCT00119938|Behavioral|Access to online patient portal|
16366809|NCT00119925|Behavioral|patient education|patient leaflets about national guideline contents
16366810|NCT00119925|Behavioral|professional audit and feedback (guideline adherence)|feedback on current practice according to quality indicators
16366811|NCT00119925|Behavioral|professional education (communication/shared decision making)|educational tools for professionals concerning communication and shared decision making
16366812|NCT00119925|Other|information tools|tools and checklists to improve information provision
16366813|NCT00119912|Procedure|A 1 Intervention arm Flex Sig|Screening by flexible sigmoidoscopy
16366814|NCT00119912|Procedure|A 2 Intervention arm Flex Sig + iFOBT|In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
16366815|NCT00119899|Procedure|FDG-PET scan|
16366816|NCT00119886|Drug|Botulinum toxin|
16366817|NCT00119873|Biological|VRC-HIVADV014-00-VP|
16366819|NCT00119847|Drug|Optimal Medical Therapy|Guideline-directed drug therapies after MI
16366820|NCT00119834|Device|Mechanical Circulatory Support Device (MCSD)|INTERMACS is an observational registry of adult and pediatric patients with end stage heart failure that receive a legally utilized Mechanical Circulatory Support Device.
16366821|NCT00119821|Behavioral|Weight Reducing Diet|Behavioral intervention
16366822|NCT00119821|Behavioral|Exercise|Moderate exercise implemented plus behavioral intervention.
16366823|NCT00119821|Behavioral|Smoking Cessation|"Nicotine Patch in dosages given based on number of cigarettes per day smoked. 21 mg patch, 14 mg patch, 7 mg patch for total of 6 weeks duration of therapy.
~NRT gum is being provided to assist with relapse prevention. At the randomization visit the participant is given one (1) box of 2mg NRT gum, which consists of (110) pieces. The participant may request up to two (2) more boxes, for a maximum of three (3) boxes per participant."
16366824|NCT00119795|Behavioral|Exercise|Increase Physical Activity to 150 min/wk
16366825|NCT00119795|Behavioral|Weight Loss|Lose 7-10% of body weight and increase physical activity to 150 min/wk
16366826|NCT00119795|Behavioral|Health Education Control|Lectures on information relevant to successful aging
16366827|NCT00119782|Behavioral|Diet|A dietary intervention that will promote lower calorie intake
16366828|NCT00119782|Behavioral|Exercise|A physical activity intervention combining increased daily physical activity and regular, structured exercise
16366829|NCT00119782|Behavioral|Environment|Increase worksite access to both healthy foods and physical activity
16366830|NCT00119769|Drug|Placebo|Placebo, 0.7 mg/day injected subcutaneously
16366831|NCT00119769|Drug|Genotropin (human recombinant Growth hormone)|Genotropin, 0.7 mg/day injected subcutaneously
16366832|NCT00119756|Drug|paliperidone palmitate|
16366833|NCT00119743|Biological|undecavalent pneumococcal-protein D conjugate vaccine|
16366834|NCT00119730|Drug|Fludarabine|Given on days 1-3 of each 28-day cycle
16366835|NCT00119730|Drug|Mitoxantrone|Given on day 1 of each 28-day cycle
16366836|NCT00119730|Drug|Rituximab|Given on day 1 of each 28-day cycle
16366837|NCT00119730|Drug|Zevalin|After two cycles if there is no disease progression, zevalin treatment will be given. Rituximab will be given followed by an imaging dose of zevalin. Two or three scans will be performed over a week to determine if it is safe to give the full treatment dose of zevalin. The treatment dose is given with the second infusion or rituximab, seven days after the first dose.
16366838|NCT00119717|Device|NeuroFlo™ catheter|45 minute treatment
16366839|NCT00119717|Other|Control|ASA Guidelines
16366840|NCT00119704|Drug|Botulinum toxin A injection or normal saline|
16366841|NCT00119691|Drug|Nesiritide|Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.
16366842|NCT00119678|Drug|Abatacept|Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months
16366843|NCT00119678|Drug|Placebo|Injectable, intravenous, 0 mg, every 28 days, 12 months
16366844|NCT00119678|Drug|Prednisone|Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
16366845|NCT00119678|Drug|Abatacept|Injectable, intravenous, 10 mg/kg, every 28 days
16366846|NCT00119665|Drug|MF101|
16366847|NCT00119652|Drug|quetiapine fumarate (Seroquel)|
16366848|NCT00119652|Drug|paroxetine|
16366849|NCT00119652|Behavioral|mood stabilizing activity|
16366850|NCT00119639|Drug|Sorafenib (BAY43-9006, Nexavar)|All subjects were given a open-label, single dose of 400mg sorafenib
16366851|NCT00119626|Drug|NXY-059|
16366852|NCT00119613|Drug|placebo|placebo
16366853|NCT00119613|Drug|darbepoetin alfa|darbepoetin alfa
16366854|NCT00119600|Drug|AMG 114|
16366855|NCT00119587|Drug|darbepoetin alfa|
16366856|NCT00119574|Procedure|Collaborative Chronic Illness Model|
16366857|NCT00119561|Behavioral|Telephone Support|Each telephone support group of 5 caregivers and a group leader met 14 times over a year. The hour calls were semi-structured with an educational component and a support component, led by a trained Group Leader. Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges and caregiver stress and coping.
16366858|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
16366859|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
16366860|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
16366861|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
16366862|NCT00119548|Other|Rates of HIV testing and receipt of results|Rates of HIV testing and receipt of results
16366863|NCT00119548|Other|Sexual risk reduction; HIV knowledge improvement|Sexual risk reduction; HIV knowledge improvement
16366864|NCT00119535|Behavioral|Implementation of Proactive Diabetes Eye Care Program|
16366865|NCT00119509|Procedure|HPV DNA testing|
16366866|NCT00119509|Procedure|Conventional management (repeat Pap smear at 6 months)|
16366867|NCT00119509|Procedure|Decision aid with choice of management|
16366868|NCT00119496|Drug|rosiglitazone|oral tablet, 4mg bd for 4 weeks
16366869|NCT00119496|Drug|theophylline|Oral theophylline, 200mg bd
16366870|NCT00119496|Drug|beclomethasone|inhaled beclomethasone, 200mcg bd
16366871|NCT00119496|Drug|inhaled beclomethasone and oral theophylline|inhaled beclomethasone (400mcg/day), oral theophylline (400mg/day)
16366872|NCT00119483|Drug|Nebido (Testosterone Undecanoate)|
16366873|NCT00119470|Procedure|EUS-FNA|
16366874|NCT00119470|Procedure|Conventional Surgical Technique|
16366875|NCT00119457|Drug|TTP889|
16366876|NCT00119444|Procedure|Periacetabular osteotomy|osteotomy of the pelvis to increase acetabular coverage
16366877|NCT00119431|Drug|C1 inhibitor concentrate|
16366878|NCT00119418|Drug|TU 025 Keishi Bukuryo Gan|
16366879|NCT00119392|Biological|rituximab|Given IV
16366880|NCT00119392|Drug|cyclosporine|Given orally
16366881|NCT00119392|Drug|fludarabine phosphate|Given IV
16366882|NCT00119392|Drug|mycophenolate mofetil|Given orally
16366884|NCT00119392|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
16366885|NCT00119392|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo transplantation
16366886|NCT00119392|Radiation|total-body irradiation|Undergo TBI
16366887|NCT00119379|Drug|NucleomaxX|NucleomaxX 36 grams TID every other day
16366888|NCT00119379|Drug|Tenofovir Disoproxil Fumarate|Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate
16366889|NCT00119366|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
16366890|NCT00119366|Drug|fludarabine phosphate|Given IV
16366891|NCT00119366|Radiation|total-body irradiation|Undergo TBI
16366892|NCT00119366|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo PBSC transplantation
16366893|NCT00119366|Procedure|peripheral blood stem cell transplantation|Undergo PBSC transplantation
16366894|NCT00119366|Drug|cyclosporine|Given IV or PO
16366895|NCT00119366|Drug|mycophenolate mofetil|Given PO
16366896|NCT00119366|Other|laboratory biomarker analysis|Correlative studies
16366897|NCT00119340|Drug|cyclosporine|
16366898|NCT00119340|Drug|fludarabine phosphate|
16366899|NCT00119340|Drug|mycophenolate mofetil|
16366900|NCT00119340|Procedure|peripheral blood stem cell transplantation|
16366901|NCT00119340|Radiation|radiation therapy|
16366902|NCT00119314|Drug|capecitabine|
16366903|NCT00119314|Drug|docetaxel|
16366904|NCT00119314|Drug|gemcitabine hydrochloride|
16366905|NCT00119314|Procedure|positron emission tomography|
16366906|NCT00119301|Drug|leucovorin calcium|
16366907|NCT00119301|Drug|methotrexate|
16366908|NCT00119301|Drug|trimetrexate glucuronate|
16366909|NCT00119262|Drug|doxorubicin hydrochloride|Given IV
16366910|NCT00119262|Drug|cyclophosphamide|Given IV
16366911|NCT00119262|Biological|bevacizumab|Given IV
16366912|NCT00119262|Drug|paclitaxel|Given IV
16366913|NCT00119262|Biological|filgrastim|Given SC
16366914|NCT00119262|Biological|pegfilgrastim|Given SC
16366915|NCT00119262|Radiation|radiation therapy|Undergo radiation therapy
16366916|NCT00119262|Drug|tamoxifen citrate|Given orally
16366917|NCT00119262|Drug|aromatase inhibition therapy|Receive aromatase inhibition therapy
16366918|NCT00119249|Drug|sorafenib tosylate|Given orally
16366919|NCT00119249|Other|laboratory biomarker analysis|Correlative studies
16366920|NCT00119236|Drug|tanespimycin|
16366921|NCT00119236|Drug|irinotecan hydrochloride|
16366922|NCT00119210|Drug|Bupropion SR|
16366923|NCT00119210|Other|placebo|
16366924|NCT00119197|Biological|killed whole cell oral cholera vaccine|"Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
~Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells
~Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells
~Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells
~Inactivated V.Cholerae O139 - 50.109 cells
~each 1.5 mL dose given orally, two doses given 14 days apart"
16366925|NCT00119197|Biological|Heat Killed E. coli|"Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine.
~Each 1.5 mL dose given orally, two doses given 14 days apart"
16366926|NCT00119184|Procedure|External cephalic version|7.5 mg bupivacaine intrathecally
16366927|NCT00119184|Drug|spinal anesthesia|spinal anesthesia
16366928|NCT00119171|Drug|Ispinesib|
16366929|NCT00119171|Drug|Capecitabine|
16366930|NCT00119158|Drug|Combination of pimecrolimus and fluticasone|Pimecrolimus cream twice a day and fluticasone cream once a day
16366931|NCT00119158|Drug|pimecrolimus|apply daily with fluticasone cream for flares
16366932|NCT00119145|Drug|artesunate-amodiaquine|
16366933|NCT00119145|Drug|coartem|
16366934|NCT00119145|Drug|artesunate-lapdap|
16366935|NCT00119132|Drug|artesunate-amodiaquine|
16366936|NCT00119132|Drug|sulphadoxine-pyrimethamine|
16366937|NCT00119119|Drug|pentoxyphilline|
16366938|NCT00119119|Drug|tocopherol|
16366939|NCT00119106|Drug|Tenofovir disoproxil|Antiretroviral
16366940|NCT00119106|Drug|Placebo|Placebo
16366941|NCT00119093|Procedure|Laboratory and clinical monitoring regimens|
16366942|NCT00119080|Biological|meningococcal conjugate vaccine (Menactra)|
16366943|NCT00119067|Biological|BioThrax or Anthrax Vaccine Adsorbed|
16366944|NCT00119054|Behavioral|In Home Health Messaging Device|
16366945|NCT00119041|Behavioral|The Diabetes Treatment Satisfaction Questionnaire|A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
16366946|NCT00119041|Behavioral|Diabetes Empowerment Scale|A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
16366947|NCT00119041|Behavioral|CBOC's undergo half-day joint-clinics via teleconference|A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
16366948|NCT00119028|Procedure|Depression Care Quality Improvement Implementation|We will used a randomized design to evaluate long term (18-month) cost effectiveness of TIDES collaborative care in six intervention clinics with fully-implemented collaborative care compared to three matched and randomly-assigned usual care clinics. We used a non-randomized quasiexperimental design (untreated control group with pretest and posttest) to measure impacts on clinician performance, knowledge, and attitudes in 6 newly-implemented collaborative care intervention clinics compared to 6 matched usual care clinics
16366949|NCT00119015|Drug|Placebo|
16366950|NCT00119015|Drug|Montelukast|
16366951|NCT00119015|Drug|Fluticasone propionate|
16366952|NCT00119002|Drug|dexamethasone|1mg/kg dexamethasone
16366953|NCT00119002|Drug|Placebo|1mg/kg placebo
16366954|NCT00118989|Dietary Supplement|Curcuminoids|Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
16366955|NCT00118976|Drug|Lisinopril|
16367158|NCT00117897|Drug|pegfilgrastim|
16366956|NCT00118963|Drug|Metformin|Tablets of 500 mg; 1000 mg two times daily.
16366957|NCT00118963|Drug|Insulin BIAsp30 (Novolog 70/30)|Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
16366958|NCT00118963|Drug|Repaglinide|Tablets of 1 mg; Dosage: 2 mg three times daily.
16366959|NCT00118963|Drug|Placebo-Metformin|Tablets corresponding to 500 mg; two tablets two times daily.
16366960|NCT00118963|Drug|Placebo-Repaglinide|Tablet corresponding to 1 mg; two tablets three times daily.
16366961|NCT00118950|Drug|Metformin|Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
16366962|NCT00118950|Drug|Repaglinide|Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
16366963|NCT00118950|Drug|Placebo-Metformin.|Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
16366964|NCT00118950|Drug|Placebo-Repaglinide.|Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
16366965|NCT00118950|Other|Diet-only.|Diet-only treatment. Duration: One month.
16366966|NCT00118937|Drug|Metformin|Tablet Metformin 500 mg, Dosage: 1000 mg two times daily (2000 mg total daily dose).
16366967|NCT00118937|Drug|Placebo.|Tablet Placebo (corresponding to 500 mg metformin). Dosage: 1 tablet per day.
16366968|NCT00118937|Drug|Placebo.|Tablet Placebo (corresponding to 500 mg metformin). Dosage: 2 tablets two times daily.
16366969|NCT00118924|Biological|LGT(TP21)/DEN4|Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
16366970|NCT00118924|Biological|Placebo|Placebo for LGT(TP21)/DEN4 vaccine
16366971|NCT00118911|Behavioral|Cognitive behavioral therapy (CBT)|Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
16366972|NCT00118911|Other|Relaxation techniques and education about ADHD|Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
16366973|NCT00118898|Drug|Abacavir/Lamivudine|600 mg abacavir/300 mg lamivudine tablet taken orally daily
16366974|NCT00118898|Drug|Atazanavir|300 mg tablet taken orally daily
16366975|NCT00118898|Drug|Efavirenz|600 mg tablet taken orally daily
16366976|NCT00118898|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
16366977|NCT00118898|Drug|Ritonavir|100 mg tablet taken orally daily
16366978|NCT00118898|Drug|Abacavir/Lamivudine placebo|Placebo tablet taken orally daily
16366979|NCT00118898|Drug|Emtricitabine/Tenofovir disoproxil fumarate placebo|Placebo tablet taken orally daily
16366980|NCT00118885|Behavioral|Tai Chi Chih|
16366981|NCT00118872|Drug|LGG yogurt|Lactobacillus GG containing yogurt
16366982|NCT00118872|Other|Placebo yogurt|Yogurt NOT containing the active LGG bacteria
16366983|NCT00118859|Behavioral|Integrative care for low back pain|
16366984|NCT00118859|Behavioral|Conventional treatment for low back pain|
16366985|NCT00118846|Dietary Supplement|25 g soy protein supplement|25 g soy protein admisitered in equally divided dosage twice daily
16366986|NCT00118846|Other|Matching placebo|Milk protein administered twice daily
16366987|NCT00118833|Drug|Hypericum perforatum (St. John's wort)|
16366988|NCT00118820|Drug|IV Preoperative antibiotic or placebo|
16366989|NCT00118807|Drug|Amodiaquine plus artesunate (AQ/AS)|
16366990|NCT00118807|Drug|Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)|
16366991|NCT00118807|Drug|Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)|
16366992|NCT00118794|Drug|Chlorproguanil-dapsone (Lapdap)|
16366993|NCT00118794|Drug|Lumefantrine-artemether (Coartemether )|
16366994|NCT00118781|Drug|iseganan hydrochloride|
16366995|NCT00118768|Drug|valopicitabine|
16366996|NCT00118768|Drug|Pegylated Interferon Alfa|
16366997|NCT00118755|Drug|capecitabine|850 mg/m^2 po bid on Days 1-14 of each 3-week cycle
16366998|NCT00118755|Drug|Oxaliplatin|130 mg/m^2 IV on Day 1 of each 3-week cycle
16366999|NCT00118755|Drug|bevacizumab|7.5 mg/kg IV on Day 1 of each 3-week cycle
16367000|NCT00118755|Drug|capecitabine|1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle
16367001|NCT00118755|Drug|Oxaliplatin|85 mg/m^2 IV on Day 1 of each 2-week cycle
16367002|NCT00118755|Drug|bevacizumab|5 mg/kg IV on Day 1 of each 2-week cycle
16367003|NCT00118742|Drug|mycophenolate mofetil [CellCept]|1-1.5 g orally or intravenously twice daily
16367004|NCT00118742|Drug|Tacrolimus|As prescribed, for 12 months
16367005|NCT00118742|Drug|Cyclosporine|As prescribed, for 12 months
16367006|NCT00118742|Drug|Sirolimus|2-4 mg orally once daily for 9-11 months
16367007|NCT00118729|Drug|GW685698X Aqueous Nasal Spray|
16367008|NCT00118716|Drug|Fluticasone propionate/salmeterol|Fluticasone propionate/salmeterol
16367009|NCT00118716|Drug|Fluticasone Propionate|Fluticasone Propionate
16367010|NCT00118703|Drug|GW685698X|
16367011|NCT00118690|Drug|Fluticasone propionate/salmeterol|
16367012|NCT00118677|Procedure|Treatment interruption|
16367013|NCT00118638|Drug|Darbepoetin alfa - 2.25 mcg/kg|Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
16367014|NCT00118638|Drug|Darbepoetin alfa - 500mcg|Darbepoetin alfa 500mcg Q3W dosing / placebo QW
16367015|NCT00118625|Biological|Tree MATA MPL|
16367016|NCT00118612|Biological|Tree MATA MPL - Therapeutic Regimen|600, 1600, 4000, 4000 SU/0.5 mL
16367017|NCT00118612|Biological|Tree MATA MPL - Intermediate dose|300, 600, 1600, 1600 SU/0.5 mL
16367018|NCT00118612|Biological|Tree MATA MPL - Low dose|300, 300, 300, 300 SU/0.5 mL
16367019|NCT00118612|Biological|Placebo|L-tyrosine 2% w/v , 4 injections
16367020|NCT00118573|Procedure|EVAR (Endovascular repair of Abdominal Aortic aneurysm)|AAA repair with endografting
16367021|NCT00118573|Procedure|Surveillance|Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
16367022|NCT00118560|Behavioral|Physical exercise|treadmill walking
16367023|NCT00118560|Behavioral|Physical walking|calf muscle exercise
16367024|NCT00118547|Behavioral|In home monitoring with feedback|Behavioral counseling
16367025|NCT00118534|Behavioral|Integrated Care for Smoking Cessation in PTSD patients|Smoking cessation therapy is integrated with PTSD therapy.
16367026|NCT00118534|Behavioral|Standard of Care|Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
16367027|NCT00118521|Procedure|Foot Orthotics|
16367028|NCT00118521|Procedure|Physiotherapy|
16367029|NCT00118508|Drug|risedronate (including placebo)|risedronate 35mg weekly
16367030|NCT00118495|Drug|Non-prescription Zestra(TM): patented formulation|
16367031|NCT00118482|Drug|fludrocortisone acetate|Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
16367032|NCT00118469|Behavioral|Psychoeducation|
16367033|NCT00118469|Behavioral|Cognitive behavior therapy|
16367034|NCT00118456|Drug|AEE788|
16367035|NCT00118443|Behavioral|Question, Persuade, Refer (QPR) training|
16367036|NCT00118430|Behavioral|Stepped Care|Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
16367037|NCT00118430|Drug|Antidepressants|Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).
16367038|NCT00118430|Drug|Usual Care|This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
16367039|NCT00118417|Drug|Clonazepam|Participants will receive clonazepam.
16367040|NCT00118417|Drug|Sertraline|Participants will receive sertraline.
16367041|NCT00118417|Behavioral|Cognitive behavioral therapy|Participants will receive cognitive behavioral therapy
16367042|NCT00118404|Behavioral|Continuation phase cognitive therapy|Continuation phase cognitive therapy included 10 sessions over 8 months.
16367043|NCT00118404|Drug|Continuation phase fluoxetine|The dosage of fluoxetine was increased to 40 mg over 8 months.
16367044|NCT00118404|Other|Continuation phase pill placebo|The dosage of pill placebo was increased to 40 mg over 8 months.
16367045|NCT00118404|Behavioral|Acute phase cognitive therapy|For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
16367046|NCT00118391|Behavioral|Cognitive behavior therapy|Receive 8 50-minute sessions of one-on-one cognitive behavioral therapy
16367047|NCT00118391|Behavioral|Contingency management|Receive vouchers that can be spent on rewards for completing activities that support abstinence from gambling
16367048|NCT00118378|Drug|Modafinil|50 mg per day, increasing to 200 mg per day as clinically indicated
16367049|NCT00118378|Drug|Placebo|50 mg per day, increasing to 200 mg per day as clinically indicated
16367050|NCT00118365|Other|placebo|Given orally
16367051|NCT00118365|Drug|eflornithine|Given orally
16367052|NCT00118365|Drug|sulindac|Given orally
16367053|NCT00118365|Other|laboratory biomarker analysis|Correlative studies
16367054|NCT00118352|Biological|alemtuzumab|Given IV
16367055|NCT00118352|Radiation|total-body irradiation|Undergo low-dose TBI
16367056|NCT00118352|Drug|fludarabine phosphate|Given IV
16367057|NCT00118352|Drug|cyclosporine|Given PO or IV
16367058|NCT00118352|Drug|mycophenolate mofetil|Given PO
16367059|NCT00118352|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic stem cell transplantation
16367060|NCT00118352|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16367061|NCT00118352|Biological|graft versus host disease prophylaxis/therapy|Undergo GVHD prophylaxis/therapy
16367062|NCT00118352|Other|laboratory biomarker analysis|Correlative studies
16367063|NCT00118339|Drug|chemoprotection|
16367064|NCT00118339|Procedure|complementary or alternative medicine procedure|
16367065|NCT00118339|Procedure|management of therapy complications|
16367066|NCT00118326|Biological|filgrastim|
16367067|NCT00118326|Procedure|allogeneic bone marrow transplantation|
16367068|NCT00118313|Biological|incomplete Freund's adjuvant|
16367069|NCT00118313|Biological|multi-epitope melanoma peptide vaccine|
16367070|NCT00118313|Biological|sargramostim|
16367071|NCT00118313|Biological|tetanus toxoid helper peptide|
16367072|NCT00118313|Drug|dimethyl sulfoxide|
16367073|NCT00118313|Drug|imiquimod|
16367074|NCT00118313|Procedure|adjuvant therapy|
16367075|NCT00118300|Drug|capecitabine|Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
16367076|NCT00118300|Radiation|brachytherapy|1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)* intracavitary brachytherapy once weekly in weeks 4-8.
16367077|NCT00118300|Radiation|radiation therapy|Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5.
16367078|NCT00118287|Drug|azacitidine|Given SC or IV
16367079|NCT00118287|Biological|etanercept|Given SC
16367080|NCT00118274|Biological|incomplete Freund's adjuvant|Given intradermally and subcutaneously
16367081|NCT00118274|Biological|melanoma helper peptide vaccine|Given intradermally and subcutaneously
16367082|NCT00118274|Biological|multi-epitope melanoma peptide vaccine|Given intradermally and subcutaneously
16367083|NCT00118274|Biological|tetanus toxoid helper peptide|Given intradermally and subcutaneously
16367084|NCT00118274|Drug|cyclophosphamide|Given IV
16367159|NCT00117897|Drug|Filgrastim|
16372798|NCT00003549|Drug|methotrexate|
16367085|NCT00118261|Biological|bevacizumab|Beginning in course 3, patients also receive bevacizumab IV over 30 minutes. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
16367086|NCT00118261|Drug|erlotinib hydrochloride|Courses 1-3: oral erlotinib once daily on days 1-14. Patients who do not develop grade 2 toxicity after the first 3 courses (6 weeks) will have their erlotinib dose escalated. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
16367087|NCT00118261|Drug|fluorouracil|Starting with course 2: fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
16367088|NCT00118261|Drug|leucovorin calcium|Starting with course 2: Leucovorin calcium IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
16367089|NCT00118261|Drug|oxaliplatin|Starting with course 2: oxaliplatin IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
16367090|NCT00118248|Drug|tanespimycin|Given IV
16367091|NCT00118235|Drug|cisplatin|Given IV
16367092|NCT00118235|Drug|irinotecan hydrochloride|Given IV
16367093|NCT00118235|Biological|bevacizumab|Given IV
16367094|NCT00118235|Other|laboratory biomarker analysis|Correlative studies
16367095|NCT00118222|Drug|porfimer sodium|All patients receive porfimer sodium IV.
16367096|NCT00118222|Procedure|adjuvant therapy|All patients receive porfimer sodium IV.
16367097|NCT00118222|Procedure|conventional surgery|All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
16367098|NCT00118209|Biological|rituximab|IV
16367099|NCT00118209|Drug|cyclophosphamide|IV
16367100|NCT00118209|Drug|doxorubicin|IV or CIVI
16367101|NCT00118209|Drug|vincristine|IV or CIVI
16367102|NCT00118209|Drug|prednisone|oral
16367103|NCT00118209|Drug|etoposide|CIVI
16367104|NCT00118209|Drug|filgrastim|IV
16367105|NCT00118209|Drug|pegfilgrastim|IV
16367106|NCT00118196|Drug|arsenic trioxide|
16367107|NCT00118196|Drug|azacitidine|
16367108|NCT00118183|Drug|docetaxel|Given IV
16367109|NCT00118183|Biological|cetuximab|Given IV
16367110|NCT00118183|Drug|bortezomib|Given IV
16367111|NCT00118170|Drug|sorafenib tosylate|Given orally
16367112|NCT00118170|Other|pharmacological study|Correlative studies
16367113|NCT00118157|Other|Laboratory Biomarker Analysis|Correlative studies
16367114|NCT00118157|Drug|Lapatinib Ditosylate|Given PO
16367115|NCT00118157|Drug|Tamoxifen Citrate|Given PO
16367116|NCT00118144|Drug|bortezomib|Given IV
16367117|NCT00118131|Drug|cisplatin|
16367118|NCT00118131|Drug|docetaxel|
16367119|NCT00118105|Biological|bevacizumab|Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
16367120|NCT00118105|Drug|capecitabine|Pre & Post Operative: 1,700 mg/m^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4
16367121|NCT00118105|Drug|oxaliplatin|130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
16367122|NCT00118105|Procedure|conventional surgery|Resection
16367123|NCT00118092|Drug|tanespimycin|Given IV
16367124|NCT00118092|Other|laboratory biomarker analysis|Correlative studies
16367125|NCT00118066|Dietary Supplement|calcitriol|Given orally
16367126|NCT00118066|Procedure|observation|No initial intervention
16367127|NCT00118053|Biological|herceptin|
16367128|NCT00118053|Drug|carboplatin|
16367129|NCT00118053|Drug|docetaxel|
16367130|NCT00118053|Procedure|conventional surgery|Modified radical mastectomy or lumpectomy and axillary node dissection
16367131|NCT00118053|Procedure|radiation therapy|Whole breast or chest wall irradiation (as determined by radiologist)
16367132|NCT00118040|Drug|Genistein|Given orally
16367133|NCT00118040|Other|Laboratory Biomarker Analysis|Correlative studies
16367134|NCT00118040|Other|Pharmacological Study|Correlative studies
16367135|NCT00118040|Other|Placebo Administration|Given orally
16367136|NCT00118040|Procedure|Therapeutic Conventional Surgery|Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
16367137|NCT00118027|Drug|sulphadoxine-pyrimethamine intermittent preventive treatment|
16367138|NCT00118014|Drug|Sertraline|
16367139|NCT00118014|Behavioral|Habit Reversal Training|
16367140|NCT00118001|Behavioral|Worry exposure|
16367141|NCT00118001|Behavioral|Applied relaxation|
16367142|NCT00117988|Drug|tanespimycin|
16367143|NCT00117975|Biological|galiximab|given IV
16367144|NCT00117975|Biological|rituximab|Given IV
16367145|NCT00117962|Biological|cetuximab|400 mg/sq m IV over 120 min: Day 1; Week 1 250 mg/sq m IV over 60 min weekly for 6 more weeks.
16367146|NCT00117962|Drug|carboplatin|AUC = 5 q 21 days for 4 cycles
16367147|NCT00117962|Drug|pemetrexed disodium|500 mg/sq m IV q 21 days during chemoradiation and consolidation chemotherapy phases
16367148|NCT00117962|Radiation|radiation therapy|Thoracic radiotherapy: 70 Gy for 7 weeks beginning on Day 1.
16367149|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
16367150|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
16367151|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
16367152|NCT00117949|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
16367153|NCT00117936|Combination Product|Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) - low dose|Up to ten intramyocardial injections of low dose FGF 1-141, via a NOGA Injection Catheter, single cath lab session
16367154|NCT00117936|Combination Product|Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) - high dose|Up to ten intramyocardial injections of high dose group (FGF-1-141), via a NOGA Injection Catheter, single cath lab session
16367155|NCT00117936|Combination Product|Placebo|Up to ten intramyocardial injections of placebo via a NOGA Injection Catheter, single cath lab session
16367156|NCT00117923|Drug|Resiquimod|
16367157|NCT00117910|Drug|pegfilgrastim|
16367160|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367161|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367162|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367163|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367164|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367165|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367166|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367167|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367168|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367169|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367170|NCT00117884|Drug|851B|851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
16367171|NCT00117871|Drug|Resiquimod|
16367172|NCT00117858|Procedure|Anodal DC polarization of left prefrontal cortex|
16367173|NCT00117845|Biological|Denileukin diftitox (Ontak)|Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
16367174|NCT00117832|Drug|Azelastine nasal spray|
16367175|NCT00117819|Drug|[123I]ß CIT and SPECT imaging|To assess [123I]ß CIT and SPECT imaging
16367176|NCT00117806|Behavioral|Arm 1|SCI-VIP: Supported employment implemented for veterans with spinal cord injury.
16367177|NCT00117806|Behavioral|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
16367178|NCT00117793|Device|Total Surface Bearing Suction Socket|Current clinical practice
16367179|NCT00117793|Device|Vacuum assisted socket system|Novel socket system
16367180|NCT00117780|Drug|insulin detemir|
16367181|NCT00117780|Drug|insulin aspart|
16367182|NCT00117767|Drug|Terbinafine hydrochloride (HCl)|Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
16367183|NCT00117767|Drug|Griseofulvin|Griseofulvin pediatric suspension o.d. administration
16367184|NCT00117754|Drug|Terbinafine hydrochloride|
16367185|NCT00117741|Behavioral|Dialectical Behavior Therapy|Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone
16367186|NCT00117741|Behavioral|Drug Counseling|Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
16367187|NCT00117728|Drug|nevirapine|
16367188|NCT00117715|Procedure|Genotyping and Phenotyping using dextromethorphan and caffeine as probes|Single doses of dextromethorphan (0.3 mg/kg)and caffeine (3.0 mg/kg) are administered and urine is collected overnight for measurement of drug and metabolites to determine drug biotransformation activity.
16367189|NCT00117702|Drug|Tacrolimus|day 0-100, then taper
16367190|NCT00117702|Drug|Everolimus|day 0-56
16367191|NCT00117689|Biological|Thymoglobulin|Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
16367192|NCT00117689|Drug|Corticosteroid|For a minimum of 3 months
16367193|NCT00117689|Drug|Tacrolimus|Between Day 3 the last dose of Thymoglobulin
16367194|NCT00117689|Drug|Mycophenolate Mofetil|for at least 1 month posttransplant
16367195|NCT00117676|Drug|TDF|300 mg tablet administered orally once daily
16367196|NCT00117676|Drug|ADV|10 mg tablet administered orally once daily
16367197|NCT00117676|Drug|TDF placebo|Tablet administered orally once daily
16367198|NCT00117676|Drug|ADV placebo|Tablet administered orally once daily
16367199|NCT00117676|Drug|FTC/TDF|200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
16367200|NCT00117663|Drug|Cessation of Hormone Replacement Therapy|
16367201|NCT00117650|Biological|Ad2/HIF-1α/VP16|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections
16367202|NCT00117650|Biological|Ad2/HIF-1α/VP16|one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
16367203|NCT00117650|Biological|Ad2/HIF-1α/VP16|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
16367204|NCT00117650|Other|Saline (Placebo Control)|a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
16367205|NCT00117637|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi kinase inhibitor
16367206|NCT00117637|Drug|Interferon|Interferon
16367207|NCT00117624|Drug|darbepoetin alfa|
16367208|NCT00117611|Drug|Anti-IgE antibody omalizumab or placebo|given subcutaneously oce or twice monthly depending on dose
16367209|NCT00117598|Drug|Temsirolimus (CCI-779)|Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
16367210|NCT00117598|Drug|Temsirolimus (CCI-779)|Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
16367211|NCT00117598|Drug|Investigator's choice|"Any of the following single agent treatments:
~Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
~Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
~Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
~Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
~Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
~Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
~Prednisone 40 (20-60) mg/m2 PO daily or every other day
~Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day"
16367212|NCT00117585|Other|Treatment Phase 1|"Patient Education
~Physical Therapy Exercises
~Increased Salt Intake
~Elevation of head of bed with 2-4 inch wedge
~Medication Review by MD, Pharma"
16367213|NCT00117585|Drug|Treatment Phase 2|"Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.
~Fludrocortisone
~Salt tablet"
16367284|NCT00117026|Drug|Placebo|Placebo for benfotiamine
16367285|NCT00117026|Drug|Benfotiamine|300mg/day
16367286|NCT00117013|Drug|Fluorine-19-Fluoroded Xyglucose|
16367214|NCT00117585|Other|Treatment Phase 3|Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.
16367215|NCT00117572|Drug|docetaxel|75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
16367216|NCT00117572|Drug|cisplatin|75 mg/m2 on day 1
16367217|NCT00117572|Drug|hydroxyurea|Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
16367218|NCT00117572|Drug|fluorouracil|750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
16367219|NCT00117572|Procedure|chemotherapy|See protocol for details
16367220|NCT00117572|Procedure|radiotherapy|See protocol for details
16367221|NCT00117559|Behavioral|Telehealth Treatment|Participants receive a 15-minute telephone call for 8 weeks
16367222|NCT00117546|Drug|alpha methyldopa|500 mg twice a day
16367223|NCT00117533|Drug|pegylated IFN alfa-2b plus ribavirin|
16367224|NCT00117520|Drug|Caffeine|
16367225|NCT00117507|Drug|Deferasirox|
16367226|NCT00117494|Drug|Pravastatin|
16367227|NCT00117494|Drug|Rosuvastatin|
16367228|NCT00117481|Drug|DR-2001a|DR-2001a administered vaginally each month
16367229|NCT00117481|Drug|DR-2001b|DR-2001b administered vaginally each month
16367230|NCT00117481|Other|Placebo|Placebo administered vaginally each month
16367231|NCT00117468|Drug|DR-2011|Administered vaginally from Day 14 to Day 31
16367232|NCT00117468|Drug|Progesterone 8% Vaginal Gel|Administered vaginally from Cycle Day 14 to Day 31
16367233|NCT00117455|Drug|pegfilgrastim|
16367234|NCT00117455|Drug|filgrastim|
16367235|NCT00117442|Drug|carboplatin|Chemotherapy
16367236|NCT00117442|Drug|paclitaxel|chemotherapy
16367237|NCT00117442|Drug|pegfilgrastim|Growth factor for mobilization
16367238|NCT00117429|Biological|HIV gp120/NefTat/AS02A Vaccine|im injection, 0.6-0.7 ml
16367239|NCT00117416|Procedure|controlling the MAP|
16367240|NCT00117403|Drug|Vitamin E, Vitamin C, and Alpha-lipoic Acid|vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals
16367241|NCT00117403|Drug|Coenzyme Q|400 mg, compounded as a wafer, two wafers three times per day with meals
16367242|NCT00117403|Drug|Placebo capsules|one placebo capsule three times per day with meals
16367243|NCT00117403|Drug|Placebo wafers|two placebo wafers three times per day with meals
16367244|NCT00117390|Procedure|Measurement of inulin clearance|
16367245|NCT00117377|Drug|Pimecrolimus|Pimecrolimus cream 1 % bid
16367246|NCT00117377|Drug|Placebo|Placebo application bid
16367247|NCT00117364|Drug|SACCHACHITIN patch|
16367248|NCT00117351|Drug|VELCADE|
16367249|NCT00117338|Drug|montelukast sodium|Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration
16367250|NCT00117338|Drug|Comparator: placebo (unspecified)|Pbo for a study approximately 120 minutes in duration
16367251|NCT00117325|Drug|GW685698X|Aqueous Nasal Spray 100mcg
16367252|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
16367253|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
16367254|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
16367255|NCT00117312|Drug|Degarelix|One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
16367256|NCT00117299|Drug|PTK787/ZK222584|PTK787/ZK222584 is administered at the dosage of 1250 mg o.d. orally
16367257|NCT00117286|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
16367258|NCT00117273|Drug|Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]|1 tablet daily
16367259|NCT00117273|Drug|Seasonique (LNG/EE and EE)|1 tablet daily
16367260|NCT00117273|Drug|Portia (LNG/EE)|1 tablet daily x 28 days
16367261|NCT00117260|Drug|Seasonale (levonorgestrel and ethinyl estradiol)|
16367262|NCT00117247|Drug|darbepoetin alfa|
16367263|NCT00117234|Drug|darbepoetin alfa|
16367264|NCT00117208|Drug|mannitol|400mg BD for 12 weeks
16367265|NCT00117208|Drug|mannitol + pulmozyme|combination
16367266|NCT00117208|Drug|Dornase alpha|2.5mg daily for 2 weeks
16367267|NCT00117195|Device|Automated Neuropsychological Assessment Matrix|"This study will evaluate a profile of neurophysiologic tests for potentially predictive signs of PD or PS in individuals with PD or PS, those who may be at risk for PD or PS and in a population of individuals without parkinsonian symptoms or any other neurologic conditions.
~In addition, the study will evaluate serum samples for changes in proteins or metabolites that may be indicators of early changes associated with Parkinson's disease or parkinsonian syndrome."
16367268|NCT00117182|Drug|Dry powder mannitol|
16367269|NCT00117182|Drug|Budesonide 400mcg administered via turbuhaler|
16367270|NCT00117182|Drug|Ipratropium bromide 80mcg|
16367271|NCT00117182|Drug|Salbutamol 400mcg|
16367272|NCT00117169|Procedure|multi-detector helical computed tomography|
16367273|NCT00117156|Drug|Fludarabine|
16367274|NCT00117156|Drug|Rituximab|
16367275|NCT00117143|Drug|Romiplostim|Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.
16367276|NCT00117130|Drug|Aranesp®|
16367277|NCT00117117|Drug|Aranesp|
16367278|NCT00117104|Drug|Aranesp®|
16367279|NCT00117091|Drug|Anakinra (Kineret®)|
16367280|NCT00117078|Drug|Aranesp®|
16367281|NCT00117065|Drug|Aranesp®|
16367282|NCT00117052|Drug|cinacalcet|All eligible subjects were assigned to receive once daily oral doses of cinacalcet, but were randomised in a 1:1 ratio to receive the drug either with the first meal after dialysis or during the dialysis visit on dialysis days.
16367283|NCT00117039|Drug|Aranesp®|
16367288|NCT00117000|Drug|testosterone undecanoate|
16367289|NCT00116987|Device|Dual chamber cardiac pacemaker|Physiologic pacemakers usually have two leads - one positioned in the right atrium (upper heart chamber) and one positioned in the right ventricle.
16367290|NCT00116987|Device|Single chamber cardiac pacemaker|Ventricular pacemakers have a single lead (wire) positioned in the right ventricle (lower pumping chamber) to sense and pace the ventricle.
16367291|NCT00116974|Procedure|Scaling and root planing|Scaling and root planing
16367292|NCT00116961|Drug|Velcade|
16367293|NCT00116961|Drug|Doxil|
16367294|NCT00116961|Drug|Dexamethasone|
16367295|NCT00116948|Device|ReCap, Hip resurfacing system, Biomet|ReCap total hip arthroplasty inserted according to manufactures manual.
16367296|NCT00116935|Drug|imatinib mesylate|imatinib 400 mg/day orally qd for 12 months
16367297|NCT00116935|Drug|imatinib|imatinib 400 mg/d orally qd for 36 months
16367298|NCT00116935|Drug|imatinib|imatinib 400 mg/d orally qd for 36 months
16367299|NCT00116922|Drug|Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID|[Rosiglitazone 2mg/ Metformin 500mg] twice daily
16367300|NCT00116909|Drug|OSI 7904L|
16367301|NCT00116896|Drug|OSI-7904L|
16367302|NCT00116896|Drug|Cisplatin|
16367303|NCT00116883|Drug|GW685698X aqueous nasal spray|
16367304|NCT00116870|Drug|lovastatin|
16367305|NCT00116857|Drug|Sertraline/omega-3|Sertraline (50 mgs) plus omega-3 (2 grams)
16367306|NCT00116857|Drug|Sertraline/Corn Oil|Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
16367307|NCT00116844|Drug|Valaciclovir|Valtrex 1g once daily
16367308|NCT00116844|Drug|Placebo|placebo
16367309|NCT00116831|Drug|Glipizide|oral anti-diabetic medication
16367310|NCT00116831|Drug|rosiglitazone maleate|oral antidiabetic medication
16367311|NCT00116818|Drug|GW685698X aqueous nasal spray|
16367312|NCT00116805|Drug|TDF|300 mg tablet administered orally once daily
16367313|NCT00116805|Drug|ADV|10 mg tablet administered orally once daily
16367314|NCT00116805|Drug|TDF placebo|Tablet administered orally once daily
16367315|NCT00116805|Drug|ADV placebo|Tablet administered orally once daily
16367316|NCT00116805|Drug|FTC/TDF|200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
16367317|NCT00116792|Procedure|Percutaneous Coronary Intervention (PCI)|
16367318|NCT00116779|Drug|Degarelix|Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
16367319|NCT00116766|Device|anti-mosquito plant use|
16367320|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
16367321|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
16367322|NCT00116753|Drug|Degarelix|Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
16367323|NCT00116740|Drug|APD356|
16367324|NCT00116727|Drug|ENBREL®|50 mg/wk SC
16367325|NCT00116714|Drug|DMARD|All subjects were required to initiate, add or change DMARD therapy at study entry.
16367326|NCT00116701|Drug|Aranesp®|
16367327|NCT00116688|Biological|Romiplostim|Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
16367328|NCT00116675|Drug|Resiquimod|
16367329|NCT00116662|Drug|Resiquimod|
16367330|NCT00116649|Drug|imiquimod cream|imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
16367331|NCT00116636|Drug|Kaletra|
16367332|NCT00116623|Drug|Indomethacin|
16367333|NCT00116623|Drug|Magnesium sulfate|
16367334|NCT00116610|Drug|picoplatin|
16367335|NCT00116597|Genetic|Intranodal immunization with a recombinant vaccinia virus expressing 5 transgenes|
16367336|NCT00116597|Biological|Intranodal booster immunizations with synthetic melanoma associated epitopes|
16367337|NCT00116584|Drug|heliox|continuous heliox therapy
16367338|NCT00116584|Drug|oxygen|continuous oxygen therapy
16367339|NCT00116571|Drug|Lemuteporfin for injection|
16367340|NCT00116571|Device|Transurethral drug delivery system|
16367341|NCT00116571|Device|Transurethral light delivery system|
16367342|NCT00116558|Device|Early NIPPV|Early intervention with non-invasive positive pressure ventilation (NIPPV) at 80% forced vital capacity (FVC).
16367343|NCT00116558|Device|Standard NIPPV|Standard of care non-invasive positive pressure ventilation (NIPPV) at 50% forced vital capacity (FVC).
16367344|NCT00116545|Drug|troglitazone|
16367345|NCT00116532|Drug|Escitalopram|
16367346|NCT00116519|Drug|PPAR alpha|
16367347|NCT00116519|Drug|placebo|
16367348|NCT00116506|Drug|erlotinib|
16367349|NCT00116506|Drug|FOLFOX|
16367350|NCT00116506|Drug|bevacizumab|
16367351|NCT00116493|Dietary Supplement|Iron-folic acid and mebendazole|"100 mg iron for pregnant women, 25 mg iron for children
~1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children"
16367352|NCT00116493|Drug|Mebendazole|100 mg twice a day for 3 days; Iron-folic acid also given
16367353|NCT00116493|Dietary Supplement|Multivitamins|Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
16367354|NCT00116493|Drug|Mebendazole + Multivitamin|Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
16367355|NCT00116480|Drug|Misoprostol|600 mcg of sublingual misoprostol
16367356|NCT00116467|Biological|GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)|
16367357|NCT00116454|Drug|131 I-lipiodol|intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment
16367358|NCT00116441|Biological|Therapeutic Cellular Vaccine, GM-CSF Producing|
16367473|NCT00115505|Other|Questionnaire Administration|Complete the Employment and Informal Care Cost Assessment and Peripheral Neuropathy Assessments
16367474|NCT00115492|Drug|Fluticasone Propionate/Salmeterol Combination Product|
16367475|NCT00115492|Drug|Salmeterol|
16367359|NCT00116428|Device|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
16367360|NCT00116428|Drug|Antiarrhythmic drug|Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.
16367361|NCT00116415|Drug|efavirenz; didanosine EC; lamivudine|
16367362|NCT00116402|Drug|fluticasone and salmeterol|"will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
~will start with salmeterol 50 mcg BID first and then crossover to combination therapy with fluticasone 220 mcg BID."
16367363|NCT00116389|Drug|talabostat mesylate tablets|
16367364|NCT00116389|Drug|gemcitabine|
16367365|NCT00116376|Drug|AEE788|
16367366|NCT00116363|Genetic|investigational drug INGN 241|
16367367|NCT00116350|Drug|Misoprostol|800 mcg sublingual misoprostol
16367368|NCT00116350|Drug|Oxytocin|40 IU Oxytocin IV
16367369|NCT00116337|Procedure|Spinal Cord Stimulation to restore cough|Participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit.
16367370|NCT00116337|Device|Expiratory Muscle Stimulator|The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
16367371|NCT00116324|Drug|Montelukast|
16367372|NCT00116311|Behavioral|allergen inhalation|
16367373|NCT00116311|Behavioral|withdrawal of medication|
16367374|NCT00116311|Procedure|sputum induction|
16367375|NCT00116298|Drug|stavudine, efavirenz, lamivudine|
16367376|NCT00116285|Biological|Ragweed MATA MPL|
16367377|NCT00116272|Drug|Etanercept|Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.
16367378|NCT00116259|Drug|Aripiprazole|
16367379|NCT00116246|Procedure|McRobert's manoeuvre|
16367380|NCT00116233|Device|REPEL-CV|
16367381|NCT00116220|Drug|Flutamide (Eulexin) and Lupron or Zoladex|Androgen suppression therapy
16367382|NCT00116220|Radiation|External Beam Radiotherapy|Once a day, 4-5 days per week for approximately 2 months
16367383|NCT00116207|Drug|ORAL ANTIOXIDANT|Comparison of triple antioxidant combination therapy vs placebo.
16367384|NCT00116194|Behavioral|Physical Activity|
16367385|NCT00116181|Drug|Etanercept|"All subjects will administer etanercept 50 mg twice weekly subcutaneously (2 injections of 25 mg etanercept SC within 1 hour twice weekly) for the first 12 weeks of study.
~Subjects randomized to the continuous therapy arm will then receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24. Subjects randomized to the intermittent therapy arm will be assessed for response. Those who achieve a responder status on the PGA (PGA score £ 2 and improved from baseline) at week 12 will discontinue therapy. Upon relapse of PGA responder status, etanercept will be administered 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) through week 24."
16367386|NCT00116168|Biological|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
16367387|NCT00116168|Biological|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
16367388|NCT00116168|Biological|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
16367389|NCT00116168|Biological|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
16367390|NCT00116155|Biological|CV787 (CG7870)|
16367391|NCT00116142|Drug|Docetaxel|60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.
16367392|NCT00116142|Drug|Androgen Hormonal Suppression and Radiation|Total Androgen Ablation and external beam radiation therapy
16367393|NCT00116142|Drug|Androgen Suppression Therapy and Radiation Therapy|Total Androgen Ablation and External Beam Radiation Therapy
16367394|NCT00116129|Drug|Ibutamoren Mesylate (MK-0677)|Ibutamoren Mesylate 25 mg/day
16367395|NCT00116116|Drug|efavirenz, stavudine extended release, lamivudine|
16367396|NCT00116103|Drug|Tacrolimus Inhalation Aerosol|
16367397|NCT00116064|Drug|intranasal lorazepam|
16367398|NCT00116064|Drug|intramuscular paraldehyde|
16367399|NCT00116051|Device|Acetabular implant, Monoblock cup|
16367400|NCT00116038|Device|Femoral implant (Versys Fiber Metal Taper®)|
16367401|NCT00116025|Drug|Human acylated ghrelin|
16367402|NCT00116012|Drug|rNAPc2|
16367403|NCT00115999|Drug|alfimeprase|
16367404|NCT00115986|Biological|Influenza A/H5N1 Vaccine|
16367405|NCT00115973|Device|pump|
16367406|NCT00115973|Drug|insulin aspart|
16367407|NCT00115960|Biological|HIV-1 gag DNA|DNA vaccine containing the HIV gene gag
16367408|NCT00115960|Biological|IL-15 DNA adjuvant|Cytokine injection
16367409|NCT00115960|Biological|IL-12 DNA adjuvant|Cytokine injection
16367410|NCT00115947|Drug|Terlipressin|
16367411|NCT00115934|Procedure|Blalock-Taussig pulmonary artery shunt|Performed at stage I palliative surgery for babies born with HLHS
16367412|NCT00115934|Procedure|Right ventricular to pulmonary artery shunt|Performed at stage I palliative surgery for babies born with HLHS
16367413|NCT00115921|Behavioral|Provision of antimalarial treatment at home|
16367414|NCT00115908|Drug|Albuferon|
16367415|NCT00115908|Drug|Ribavirin|
16367416|NCT00115908|Drug|PEG-IFNalfa2a|
16367417|NCT00115895|Drug|Radioactive iodine|Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
16367476|NCT00115479|Drug|intensive insulin therapy to maintain normoglycemia|
16367418|NCT00115882|Behavioral|MI + CBST|The HS Study intervention consisted of proactive identification and recruitment of eligible smokers (and selected nonsmokers) within the target population, and a protocol-guided series of counselor-initiated, personally-tailored telephone calls (from 1 to 10, depending on participant's interest) to eligible high school senior smokers and nonsmokers in experimental high schools. The telephone-delivered behavioral intervention integrated Motivational Interviewing and Cognitive Behavioral Skills building. Content and dose were tailored to the individual.
16367419|NCT00115869|Behavioral|Social-influences|grades 3-10, school-based social influences tobacco use prevention curriculum
16367420|NCT00115856|Procedure|Intravascular MRI|Arterial imaging of atherosclerosis
16367421|NCT00115843|Device|Mobile Cardiac Outpatient Telemetry|
16367422|NCT00115830|Drug|Atorvastatin|
16367423|NCT00115830|Drug|Rosuvastatin|
16367424|NCT00115817|Drug|Atorvastatin|
16367425|NCT00115804|Drug|Fluoxetine|Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
16367426|NCT00115791|Drug|RSD1235|IV
16367427|NCT00115791|Drug|placebo|IV
16367428|NCT00115778|Drug|IVIG|10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
16367429|NCT00115778|Other|Placebo|0.1% Albumin in an equal volume to the investigational product
16367430|NCT00115765|Drug|Oxaliplatin Based Chemotherapy|Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
16367431|NCT00115765|Drug|Panitumumab|PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.
16367432|NCT00115765|Drug|Irinotecan Based Chemotherapy|Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.
16367433|NCT00115765|Drug|Bevacizumab|Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .
16367434|NCT00115752|Drug|Valdecoxib|
16367435|NCT00115752|Drug|COX Inhibitor|
16367436|NCT00115739|Drug|Imatinib|Imatinib 400 mg capsules were administered twice daily with food for 4 week cycles.
16367437|NCT00115726|Drug|furosemide|for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)
16367438|NCT00115726|Drug|placebo|patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
16367439|NCT00115713|Behavioral|Aerobic Exercise Training|
16367440|NCT00115713|Behavioral|Resistance Exercise Training|
16367441|NCT00115700|Drug|Cyclophosphamide|1000 mg/m2 I.V. on day 1
16367442|NCT00115700|Radiation|Radiotherapy|The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.
16367443|NCT00115700|Drug|Vincristine|1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1
16367444|NCT00115700|Drug|Prednisolone|50 mg/m2 orally daily for days 1 - 5
16367445|NCT00115700|Drug|Rituximab|375 mg/m2 IV Infusion day 1
16367446|NCT00115687|Drug|placebo|
16367447|NCT00115687|Drug|2 mg nicotine polacrilex|
16367448|NCT00115661|Drug|Rosiglitazone|
16367449|NCT00115648|Drug|Nevirapine|Oral NVP daily dosage
16367450|NCT00115648|Drug|AZT|Oral AZT daily
16367451|NCT00115648|Drug|NVP and AZT|Oral single dose NVP plus oral daily AZT during the first weeks
16367452|NCT00115648|Drug|NVP|Oral NVP daily to age 14 weeks
16367453|NCT00115648|Drug|NVP+AZT|Oral NVP daily plus oral AZT daly to age 14 weeks
16367454|NCT00115635|Drug|docetaxel|
16367455|NCT00115635|Drug|gemcitabine|
16367456|NCT00115622|Drug|fluticasone furoate|
16367457|NCT00115609|Drug|efavirenz|800mg for patients treated by rifampicine 600mg for other patients
16367458|NCT00115609|Drug|tenofovir DF|300mg once a day
16367459|NCT00115609|Drug|emtricitabine|one pill of 200mg once a day
16367460|NCT00115596|Other|Formal Curriculum; Low-Fidelity Simulation|The intervention was a formal procedural skills training curriculum consisting of didactic lectures and simulation training.
16367461|NCT00115583|Drug|Drug Infusion (BQ-123)|
16367462|NCT00115570|Drug|Insulin glulisine|Subcutaneous injection
16367463|NCT00115570|Drug|insulin lispro|Subcutaneous injection
16367464|NCT00115570|Drug|insulin glargine|Subcutaneous injection once daily
16367465|NCT00115570|Drug|NPH insulin|subcutaneous injection twice daily
16367466|NCT00115557|Other|Practice intervention|Performance feedback, academic detailing, practice facilitation, IT support
16367467|NCT00115557|Other|Practice intervention 2|Performance feedback only.
16367468|NCT00115544|Drug|Stanate|Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
16367469|NCT00115531|Biological|Trivalent inactivated influenza vaccine|Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.
16367470|NCT00115531|Biological|Trivalent inactivated influenza vaccine|High Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.
16367471|NCT00115518|Drug|cetuximab|After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
16367472|NCT00115505|Other|quality-of-life assessment|Complete Subjective Significance Questionnaire, MOS Social Support Survey, Patient Preferences, CALGB Background Information, and EQ-5D and QOL Assessment Form, EORTC QLQ-C30 and EORTC QLQ-BR23
16367477|NCT00115466|Procedure|Non-surgical autologous implant of ASCs|
16367478|NCT00115453|Radiation|irradiation|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
16367479|NCT00115440|Radiation|Bononophenylalanine (BPA)-based BNCT|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
16367480|NCT00115427|Drug|Liatermin (r-metHuGDNF)|
16367481|NCT00115414|Drug|pegfilgrastim|
16367482|NCT00115414|Drug|docetaxel|
16367483|NCT00115414|Drug|doxorubicin|
16367484|NCT00115414|Drug|cyclophosphamide|
16367485|NCT00019500|Drug|raloxifene|
16367486|NCT00019500|Procedure|evaluation of cancer risk factors|
16367487|NCT00115388|Procedure|Screening for chlamydia using self-taken vaginal swabs|Women in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification
16367488|NCT00115375|Drug|Clopidogrel (SR25990)|
16367489|NCT00115362|Drug|venlafaxine|
16367490|NCT00115349|Drug|Deferoxamine|Deferoxamine will be given daily for 12-24h/day 7 days a week either subcutaneous or intravenous at up to 50-60 mg/kg/day.
16367491|NCT00115349|Drug|Deferiprone (L1)|The dose of L1, 75mg/kg in three divided oral doses, is the maximum dose at which toxicity has been tested in prospective trials
16367492|NCT00115336|Drug|Intravenous Ketorolac|Intravenous ketorolac
16367493|NCT00115336|Drug|Ibuprofen|Ibuprofen, taken orally
16367494|NCT00115323|Behavioral|Problem Solving|Problem solving intervention
16367495|NCT00115323|Behavioral|Attention Control|Attention control intervention
16367496|NCT00115310|Drug|NGX-4010|
16367497|NCT00115297|Drug|Montelukast|Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.
16367498|NCT00115297|Drug|Placebo|Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
16367499|NCT00115284|Behavioral|ABIM asthma practice improvement module|
16367500|NCT00115271|Drug|Nutritional supplements|
16367501|NCT00115258|Other|parenteral nutrition titrated to measured REE|
16367502|NCT00115245|Drug|Telbivudine (LdT)|
16367503|NCT00115245|Drug|Adefovir Dipivoxil|
16367504|NCT00115219|Drug|Etanercept|
16367505|NCT00115206|Drug|Neulasta® (pegfilgrastim)|
16367506|NCT00115193|Drug|pegfilgrastim|pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
16367507|NCT00115193|Drug|pegfilgrastim|pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
16367508|NCT00115180|Other|No intervention|No intervention
16367509|NCT00115167|Drug|Placebo|Q4W
16367510|NCT00115167|Drug|Darbepoetin alfa|Q4W
16367511|NCT00115154|Drug|Aldara (imiquimod) cream, 5%|
16367512|NCT00115141|Drug|Resiquimod|
16367513|NCT00115128|Drug|filgrastim|Normal donors being treated with filgrastim for PBPC mobilization and collection
16367514|NCT00115115|Drug|Dopamine infusion to brain dead organ donors|Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys
16367515|NCT00115102|Drug|fentanyl|
16367516|NCT00115102|Drug|S-ketamine|
16367517|NCT00115089|Drug|R926112|
16367518|NCT00115089|Drug|Beclomethasone dipropionate|
16367519|NCT00115076|Drug|Efalizumab|24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
16367520|NCT00115063|Behavioral|group sessions|group sessions lead by a trained primary care clinic employee
16367521|NCT00115063|Drug|sibutramine, orlistat, diethylpropion|dosage modified according to package insert instructions at discretion of primary care physicians
16367522|NCT00115063|Behavioral|Low Calorie Diet, Health One|liquid diet for 8-12 weeks to induce weight loss
16367523|NCT00115063|Other|Intensive Medical Combination Therapy for Obesity|"Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a Treatment Toolbox."
16367524|NCT00115063|Other|Control Condition|Access to the Mayo Clinic weight management website and usual care from the primary care physician
16367525|NCT00115050|Drug|TMC114|
16367526|NCT00115037|Drug|Naltrexone|100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
16367527|NCT00115037|Drug|placebo|placebo comparer for 16 weeks in phase 2.
16367528|NCT00115037|Behavioral|Medication Management (MM)|Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
16367529|NCT00115037|Behavioral|Combined Behavioral Intervention (CBI)|45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
16367530|NCT00115037|Behavioral|Telephone Counseling|Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
16367531|NCT00115024|Drug|Micronized 17B-estradiol|
16367532|NCT00115011|Drug|Escitalopram|
16367533|NCT00114985|Device|Prostate Immobilization Device|Device placed during radiation treatment
16367534|NCT00114972|Device|Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent|Drug Eluting Stent
16367535|NCT00114972|Procedure|Coronary Artery Bypass Surgery|Coronary Artery Bypass Surgery
16367536|NCT00114959|Drug|Homoharringtonine|"Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.
~Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule."
16367593|NCT00114452|Biological|Provacel|ex vivo cultured adult mesenchymal stem cells
16367594|NCT00114452|Biological|Placebo|Placebo
16367595|NCT00114439|Drug|Lithium carbonate|
16367537|NCT00114959|Drug|Imatinib Mesylate|Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.
16367538|NCT00114946|Drug|Avastin|
16367539|NCT00114933|Drug|Stopping nucleosides and continuing lopinavir/ritonavir monotherapy|
16367540|NCT00114920|Drug|Resiquimod|
16367541|NCT00114907|Behavioral|Consumption of black tea|
16367542|NCT00114894|Other|Safe Sea ™|Safe Sea ™ applied one time at 2 mg/cm2 coverage
16367543|NCT00114894|Other|Placebo|Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage
16367544|NCT00114868|Drug|Vitamin A|
16367545|NCT00114855|Drug|HYPOCOL®|
16367546|NCT00114842|Procedure|MR colonography|
16367547|NCT00114829|Procedure|MR colonography with dynamic contrast uptake|
16367548|NCT00114816|Drug|capecitabine|
16367549|NCT00114816|Drug|docetaxel|
16367550|NCT00114803|Drug|Calcitonin nasal spray (salmon)|
16367551|NCT00114790|Radiation|boronophenylalanine-based BNCT|Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
16367552|NCT00114777|Drug|Cyclosporin A|tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
16367553|NCT00114777|Drug|Belatacept Less Intensive Regimen (LI)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
16367554|NCT00114777|Drug|Belatacept More Intensive Regimen (MI)|solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
16367555|NCT00114764|Drug|filgrastim|Filgrastim given daily after induction chemotherapy
16367556|NCT00114764|Drug|pegfilgrastim|Pegfilgrastim given once after induction chemotherapy
16367562|NCT00114725|Procedure|Laser-assisted intracytoplasmic sperm injection|
16367563|NCT00114699|Drug|CCR5mAb004|
16367564|NCT00114686|Drug|Quetiapine fumarate|
16367565|NCT00114686|Drug|lithium|
16367566|NCT00114686|Drug|divalproex|
16367567|NCT00114660|Drug|Cocoa butter application|
16367568|NCT00114634|Dietary Supplement|Egg yolk preparation with cholesterol|Egg yolk preparation with cholesterol
16367569|NCT00114634|Dietary Supplement|Egg substitute, without cholesterol|Placebo control. Egg substitute, without cholesterol
16367570|NCT00114621|Drug|Anthrax Vaccine|
16367571|NCT00114621|Procedure|Blood Chemistry|
16367572|NCT00114621|Procedure|Hematology|
16367573|NCT00114621|Procedure|Urinalysis|
16367574|NCT00114608|Device|The Focus™ Neuromuscular Stimulation System|"Electrical foot stimulation was produced by surface electrodes placed on the sole of the foot over the plantar muscle group. Electrical stimulation was delivered by The Focus™ Neuromuscular Stimulation System, Empi, Inc. (St. Paul, MN.) The crucial stimulus parameters were: biphasic symmetrical square wave at 50 pulses per second, phase duration of 300 microseconds, a starting ramp up time of 2 seconds and a finishing ramp down time of 2 seconds per stimulation cycle, and a stimulation cycle of 12 seconds on and 48 seconds off per minute. Stimulation was increased to an intensity just sufficient to create a slight visible muscle twitch. This level of intensity caused no evident discomfort in any of the subjects in our first study. Subjects were continually monitored throughout this study for any indication of discomfort.The Focus™ Neuromuscular Stimulation System created electrical stimulation of the plantar foot muscles."
16367575|NCT00114595|Drug|eicosapentaenoic acid|
16367576|NCT00114582|Procedure|family style dinner|
16367577|NCT00114569|Drug|lorazepam|
16367578|NCT00114556|Drug|zoledronic acid|
16367579|NCT00114543|Procedure|Aggressive Phototherapy 501-750g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
16367580|NCT00114543|Procedure|Aggressive Phototherapy 751-1000g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.
16367581|NCT00114543|Procedure|Conservative Phototherapy 501-750g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
16367582|NCT00114543|Procedure|Conservative Phototherapy 751-1000g|Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
16367583|NCT00114530|Biological|mHSCT|Hematopoietic progenitors were mobilized with G-CSF. After leukapheresis and CD34+ cell enrichment, the autologous product was cryopreserved. Fractionated TBI (800 cGy), CY (120 mg/kg) and equine antithymocyte globulin (90 mg/kg) were administered as previously reported (References provided in citation section of this ClinicalTrials.gov record: PubMed ID: 17452515 citation and 2.) PubMed ID: 12176878 citation).
16367584|NCT00114530|Drug|cyclophosphamide|An initial intravenous dose of 500 mg/m^2 was followed by 11 infusions of 750 mg/m^2 with mesna given for bladder protection.
16367585|NCT00114517|Drug|Oral 17B-estradiol|Oral 17B-estradiol 1 mg daily
16367586|NCT00114517|Drug|Placebo|Matched placebo oral 17B-estradiol
16367587|NCT00114504|Drug|simvastatin|simvastatin 5-10 mg/day
16367588|NCT00114491|Drug|Rosuvastatin|
16367589|NCT00114478|Drug|Epinephrine|
16367590|NCT00114478|Drug|albuterol (salbutamol)|
16367591|NCT00114465|Drug|VSL#3|VSL#3 1 sachet twice a day
16367592|NCT00114465|Other|Placebo|Placebo 1 sachel twice a day
16367596|NCT00114426|Device|non-invasive mechanical ventilation|
16367597|NCT00114413|Drug|Inhaled corticosteroids|Used for both regular asthma control and as a rescue inhaler
16367598|NCT00114413|Procedure|eNO measurement|measured by Aerocrine® NIOX device
16367599|NCT00114400|Drug|folic acid|
16367600|NCT00114400|Drug|vitamin B12|
16367601|NCT00114400|Drug|vitamin B6|
16367602|NCT00114387|Drug|DL-alpha-tocopherol|
16367603|NCT00114374|Drug|Escitalopram|
16367604|NCT00114361|Drug|Ribavirin|1200 mg a day, 48 weeks
16367605|NCT00114361|Drug|Peginterferon alpha 2a|180 µg per week, 48 weeks
16367606|NCT00114348|Procedure|R-Blocks|
16367607|NCT00114348|Procedure|Protocol II-Ida|
16367608|NCT00114322|Device|light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength|
16367609|NCT00114309|Drug|131-I-TM-601|131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
16367610|NCT00114309|Drug|131I-TM601|131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
16367611|NCT00114296|Dietary Supplement|omega-3 fatty acid|
16367612|NCT00114283|Drug|lapatinib ditosylate|Given PO
16367613|NCT00114283|Other|laboratory biomarker analysis|Correlative studies
16367614|NCT00114270|Drug|letrozole|
16367615|NCT00114270|Drug|zoledronic acid|
16367616|NCT00114257|Drug|decitabine|
16367617|NCT00114257|Drug|romidepsin|
16367618|NCT00114244|Drug|sorafenib tosylate|Given PO
16367619|NCT00114244|Drug|gemcitabine hydrochloride|Given IV
16367620|NCT00114244|Other|laboratory biomarker analysis|Correlative studies
16367621|NCT00114231|Drug|capecitabine|
16367622|NCT00114231|Drug|oxaliplatin|Given IV
16367623|NCT00114231|Procedure|neoadjuvant therapy|Undergo surgery
16367624|NCT00114231|Radiation|radiation therapy|Undergo radiotherapy
16367625|NCT00114218|Drug|Gemcitabine Hydrochloride|Given IV
16367626|NCT00114218|Drug|Docetaxel|Given IV
16367627|NCT00114205|Drug|docetaxel|
16367628|NCT00114205|Procedure|therapeutic thoracoscopy|
16367629|NCT00114192|Drug|docetaxel|
16367630|NCT00114192|Drug|thalidomide|
16367631|NCT00114179|Drug|capecitabine|Given orally
16367632|NCT00114179|Radiation|radiation therapy|Undergo radiotherapy
16367633|NCT00114179|Biological|bevacizumab|Given IV
16367634|NCT00114179|Procedure|therapeutic conventional surgery|Undergo surgery
16367635|NCT00114179|Drug|gemcitabine hydrochloride|Given IV
16367636|NCT00114166|Drug|topotecan hydrochloride|
16367637|NCT00114153|Drug|capecitabine|
16367638|NCT00114153|Drug|carboplatin|
16367639|NCT00114153|Procedure|conventional surgery|
16367640|NCT00114153|Radiation|radiation therapy|
16367641|NCT00114140|Drug|Temozolomide|"Concurrent chemoradiotherapy temozolomide given 75 mg/m^2 daily during radiotherapy for 6 weeks.
~Post-Radiation Temozolomide given 150 mg/m2 daily on days 1-5 every 28 days with cycle one beginning 28 days post-radiotherapy. In the absence of grade 3 or 4 adverse events, a single dose escalation to 200 mg/m2/day could be attempted for cycle 2 and, if tolerated, that dose should continue for all subsequent cycles. Cycles were repeated every 28 days (+/- 2 days) for a total of 12 cycles."
16367642|NCT00114140|Radiation|Radiation therapy|One treatment of 1.8 Gy given daily, 5 days per week (over 6 weeks) for a total dose of 54.0 Gy.
16367643|NCT00114127|Drug|Duloxetine|60 mg duloxetine 1x per day
16367644|NCT00114127|Drug|Duloxetine|60 mg duloxetine 1x per day + 60mg duloxetine 1x per day
16367645|NCT00114127|Drug|Placebo|60mg placebo 1x per day
16367646|NCT00114114|Drug|Testosterone|Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
16367647|NCT00114114|Drug|Goserelin acetate|3.6 gms sc every 4 weeks
16367654|NCT00114088|Procedure|hysterectomy|
16367655|NCT00114088|Procedure|endometrial ablation|
16367656|NCT00114075|Procedure|Surgery with gait analysis report|Orthopaedic surgery with access to gait analysis report
16367657|NCT00114075|Procedure|Surgery without gait analysis report|Orthopaedic surgery without access to gait analysis report
16367658|NCT00114062|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
16367659|NCT00114049|Drug|GW406381|
16367660|NCT00114036|Behavioral|Quality improvement strategies|
16367661|NCT00114023|Drug|Imiquimod 5% cream|
16367662|NCT00114010|Drug|AMA1/Alhydrogel|
16367663|NCT00113997|Drug|REG1|
16367664|NCT00113984|Biological|PROSTVAC-V/TRICOM|
16367665|NCT00113984|Biological|PROSTVAC-F/TRICOM|
16367666|NCT00113984|Drug|MDX-010|
16367667|NCT00113984|Drug|Sargramostim|
16367668|NCT00113971|Drug|epratuzumab|
16367669|NCT00113958|Drug|Cinacalcet|
16367670|NCT00113945|Drug|Cinacalcet|
16367671|NCT00113932|Procedure|High-Dose Density Therapy|Dexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, & every 2 weeks until HB >12 gm/dl***; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount <30,000/μl
16367717|NCT00113607|Drug|Dexamethasone|Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.
16367718|NCT00113594|Drug|Olanzapine|
16367719|NCT00113581|Drug|EMD 72000 (matuzumab) + ECX|
16367873|NCT00112645|Procedure|allogeneic bone marrow transplantation|
16373628|NCT00083538|Drug|Thalidomide|
16367672|NCT00113919|Drug|Busulfan|Dexamethasone 40 mg PO 1-4 Thalidomide 200 mg PO 1-6 Cisplatin* 10 mg/m, Continuous infusion 1-4 Adriamycin** 10 mg/m2, Continuous infusion 1-4 Cyclophosphamide 400 mg/2, Continuous infusion 1-4 Etoposide 40 mg/m2, Continuous infusion 1-4 All doses will be based on calculated body weight (actual weight + ideal body weight ÷ 2) and height, and not to exceed a BSA of 2.0 m2 The daily dose of cyclophosphamide, etoposide, and cisplatin will be mixed in a 1L bag of NS to be UAMS infused over 24 hours. Adriamycin will be mixed in at least 50cc D5W to be infused over 24 hours
16367673|NCT00113906|Drug|melatonin|
16367674|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 30 mg thrice daily (90 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
16367675|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 60 mg thrice daily (180 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
16367676|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 90 mg thrice daily (270 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
16367677|NCT00113893|Drug|SCIO-469|SCIO-469 tablet will be administered orally at a dose of 120 mg thrice daily (360 mg per day) for 16 weeks. Participants with hematologic improvement at Week 16 and as per Investigator's discretion on clinical benefit from treatment will continue the treatment for additional 36 weeks.
16367678|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
16367679|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
16367680|NCT00113880|Biological|FluMist|Nasal Sprayer dose of FluMist with annual follow up
16367681|NCT00113854|Drug|Mannitol|
16367682|NCT00113841|Drug|Curcumin|2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
16367683|NCT00113841|Drug|Bioperine|5 mg (Tablets) orally twice daily
16367684|NCT00113828|Procedure|Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant|"Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7 and 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days-7,-6; fludarabine 25 mg/m2 on days -5, -4, -3, -2, -1.
~Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant."
16367685|NCT00113828|Procedure|T-cell depleted peripheral blood stem cell transplant|"Rabbit anti-thymocyte globulin 0.5 mg/kg on transplant day-8, 2.5 mg/kg on day-7, 3.0 mg/kg on day-6; cyclophosphamide 60 mg/kg on days -7, -6; fludarabine 25 mg/m2 on days -5 through -1.
~T-cell depleted peripheral blood stem cell transplant ."
16367686|NCT00113815|Drug|topiramate|15 mg/kg/day
16367687|NCT00113815|Drug|topiramate|5 mg/kg/day
16367688|NCT00113815|Drug|topiramate|25 mg/kg/day
16367689|NCT00113815|Drug|placebo|placebo
16367690|NCT00113802|Drug|Epratuzumab (hLL2- anti-CD22 humanized antibody)|
16367691|NCT00113789|Other|PI Discretion|PI Discretion
16367692|NCT00113776|Drug|ABX-EGF|
16367693|NCT00113763|Other|Best supportive care|Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).
16367694|NCT00113763|Drug|Panitumumab|Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.
16367695|NCT00113750|Biological|TreeMATA MPL|
16367696|NCT00113737|Drug|fluoxetine|
16367697|NCT00113737|Behavioral|cognitive behavioral therapy|
16367698|NCT00113724|Drug|TPI 287 Injection|
16367699|NCT00113711|Behavioral|smoking cessation|
16367700|NCT00113711|Behavioral|reducing diet|
16367701|NCT00113698|Drug|Enalapril|Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
16367702|NCT00113698|Other|Placebo|Placebo An inert preparation with similar appearance and taste to the drug
16367703|NCT00113685|Drug|Hypertonic Saline-Dextran Solution|
16367704|NCT00113685|Drug|Lactated Ringer's Solution|
16367705|NCT00113672|Behavioral|Increase healthy activity and increase healthy eating|Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase
16367706|NCT00113672|Behavioral|Decrease unhealthy activity and increase healthy eating|Decrease sedentary activity by 90 minutes per day and increase fruits and vegetables to 5 servings per day over the course of a 3 week prescription phase
16367707|NCT00113672|Behavioral|Increase physical activity and decrease unhealthy eating|Increase physical activity up to 60 minutes per day and decrease saturated fat to an average of 8% per day over the course of a 3 week prescription phase
16367708|NCT00113672|Behavioral|Decrease sedentary activity and decrease unhealthy eating|Decrease sedentary activity by 90 minutes per day and decrease saturated fat to and average of 8% per day over the course of a 3 week prescription phase
16367709|NCT00113659|Dietary Supplement|Probiotic|Daily dose of ten to the tenth colony-forming units of Lactobacillus GG and 225 mg of inulin for the first 6 months of life.
16367710|NCT00113659|Dietary Supplement|Placebo|Daily dose of placebo supplement containing 325mg inulin for the first 6 month of life.
16367711|NCT00113646|Drug|MEDI-507|MEDI-507 0.1 mg/kg on transplant day-8, 0.6 mg/kg on days-7 and -6
16367712|NCT00113646|Procedure|Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant|Cyclophosphamide 60 mg/kg on transplant days -7 and -6; Fludarabine 25 mg/m2 days -5,-4,-3,-2,-1; MEDI-507 0.1 mg/kg on day -8, 0.6 mg/kg on days -7,-6
16367713|NCT00113633|Behavioral|Intervention Subjects|The subject's family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups; a mailed reminder will be sent to the family to schedule a follow-up appointment.
16367714|NCT00113620|Drug|Neurodex|
16367715|NCT00113607|Drug|Trabectedin|Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.
16367716|NCT00113607|Drug|DOXIL|Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.
16367720|NCT00113568|Drug|Tranexamic acid tablets (XP12B)|Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
16367721|NCT00113555|Device|ACT (Adjustable Continence Therapy)|surgically implanted device
16367722|NCT00113542|Drug|Tetrathiomolybdate (TM)|
16367723|NCT00113529|Drug|Gefitinib + Sunitinib|Until disease progression or unacceptable toxicity.
16367724|NCT00113516|Drug|carboplatin|AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
16367725|NCT00113516|Drug|paclitaxel|175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
16367726|NCT00113516|Drug|sunitinib|50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
16367727|NCT00113503|Drug|Azathioprine weight-based dose|
16367728|NCT00113503|Drug|Azathioprine individualised dose|
16367729|NCT00113490|Biological|motavizumab (MEDI-524)|Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
16367730|NCT00113490|Biological|palivizumab 15 mg/kg|Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.
16367731|NCT00113477|Drug|Q10|
16367732|NCT00113477|Drug|Selen|
16367733|NCT00113438|Drug|Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin|Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.
16367734|NCT00113425|Device|V-Beam laser, Candela Corp., 595 nm wavelength|Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
16367735|NCT00113412|Drug|SP01A|
16367736|NCT00113399|Biological|filgrastim|
16367737|NCT00113399|Drug|cisplatin|
16367738|NCT00113399|Drug|docetaxel|
16367739|NCT00113399|Drug|fluorouracil|
16367740|NCT00113399|Drug|paclitaxel|
16367741|NCT00113399|Radiation|radiation therapy|
16367742|NCT00113386|Biological|filgrastim|Consolidation chemotherapy
16367743|NCT00113386|Biological|pegfilgrastim|Consolidation chemotherapy
16367744|NCT00113386|Drug|cisplatin|
16367745|NCT00113386|Drug|docetaxel|
16367746|NCT00113386|Procedure|adjuvant therapy|
16367747|NCT00113386|Procedure|conventional surgery|
16367748|NCT00113386|Procedure|neoadjuvant therapy|
16367749|NCT00113386|Radiation|radiation therapy|
16367750|NCT00113373|Drug|lapatinib ditosylate|Given orally
16367751|NCT00113373|Other|laboratory biomarker analysis|Correlative studies
16367752|NCT00113360|Drug|RAD001|Starting dose of 5 or 10 mg by mouth daily.
16367753|NCT00113360|Drug|Octreotide Depot|30 mg injection into the muscle of either buttock once every 28 (±7) days.
16367754|NCT00113347|Drug|Erlotinib|Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
16367755|NCT00113347|Drug|Docetaxel|15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
16367756|NCT00113347|Radiation|Radiation Therapy|Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.
16367757|NCT00113334|Drug|ABT-510|100 mg subcutaneously twice daily
16367758|NCT00113321|Drug|Decitabine|20 mg/m2 IV over 1 hour daily x 5 days.
16367759|NCT00113308|Drug|GW406381|
16367760|NCT00113295|Drug|Continued Paroxetine CR|
16367761|NCT00113295|Drug|Quetiapine|
16367762|NCT00113295|Drug|Placebo|
16367763|NCT00113282|Drug|Interleukin-2 (IL-2)|
16367764|NCT00113269|Drug|basiliximab|IV
16367765|NCT00113269|Drug|rabbit anti-thymocyte globulin|IV
16367766|NCT00113269|Drug|tacrolimus|oral
16367767|NCT00113269|Drug|alemtuzumab|Intravenous (IV)
16367768|NCT00113269|Drug|mycophenolate mofetil|oral
16367769|NCT00113269|Drug|steroids|IV and/or oral
16367770|NCT00113256|Drug|Rubitecan|
16367771|NCT00113243|Drug|adult stem cells|
16367772|NCT00113230|Drug|Avastin (Bevacizumab, RHUMAB VEGF)|Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses.
16367773|NCT00113230|Drug|Capecitabine|900 mg/m^2 by mouth twice a day during days of radiation for all five weeks of therapy.
16367774|NCT00113230|Radiation|Radiation Therapy|45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.
16367775|NCT00113217|Drug|Bevacizumab|10 mg/kg IV on day 1 of each 14-day cycle.
16367776|NCT00113204|Drug|IPI-504|
16367777|NCT00113191|Drug|Veronate|
16367778|NCT00113178|Device|Catheter-based cardiac cryoablation|
16367779|NCT00113165|Drug|LAMICTAL extended-release|
16367780|NCT00113139|Behavioral|Telephone-based coping skills/stress management|Telephone-based coping skills/stress management: 12 weekly sessions.
16367781|NCT00113139|Other|Usual Care|Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.
16367782|NCT00113126|Drug|Treatment interruption|
16367783|NCT00113113|Drug|Rubitecan|
16367784|NCT00113100|Drug|Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)|
16367785|NCT00113087|Drug|Enalapril|Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)
16367786|NCT00113087|Drug|Placebo|Participants will receive placebo
16367787|NCT00113074|Drug|Nicotine Replacement Therapy|Nicotine replacement therapy program
16367788|NCT00113074|Behavioral|Diet|Diet program
16367789|NCT00113061|Procedure|Exercise|
16367790|NCT00113048|Drug|CAMPATH (alemtuzumab)|
16367791|NCT00113022|Drug|Org 24448|250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks
16367792|NCT00113022|Drug|Placebo|Inactive equivalent of 250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks
16367793|NCT00113009|Drug|VLTS-934|
16367794|NCT00112996|Drug|alpha-lipoic acid|Oral two 300 mg ALA sustained release tablets initiated 4 days after last dose of platinum and discontinued 2 days before next scheduled platinum dose, continued for 24 weeks.
16367795|NCT00112996|Other|placebo|Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.
16367796|NCT00112983|Biological|eculizumab|
16367797|NCT00112957|Biological|rV-NY-ESO-1 vaccine|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1.
16367798|NCT00112957|Biological|rF-NY-ESO-1 vaccine|Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169.
16367799|NCT00112931|Biological|rituximab|
16367800|NCT00112931|Other|No treatment|
16367801|NCT00112918|Biological|Bevacizumab|Administered as an intravenous infusion over 30 - 90 minutes.
16367802|NCT00112918|Drug|Capecitabine|Film-coated tablets
16367803|NCT00112918|Drug|5-Fluorouracil (5-FU)|Administered as either a bolus injection or continuous intravenous infusion over 22 hours.
16367804|NCT00112918|Drug|Leucovorin calcium|Administered as a 200 mg/m^2 infusion over 2 hours.
16367805|NCT00112918|Drug|Oxaliplatin|Administered as an intravenous infusion over 2 hours.
16367806|NCT00112905|Drug|sorafenib tosylate|Given PO
16367807|NCT00112905|Other|laboratory biomarker analysis|Optional correlative studies
16367808|NCT00112892|Dietary Supplement|selenium|
16367809|NCT00112892|Drug|irinotecan hydrochloride|
16367810|NCT00112879|Drug|arsenic trioxide|
16367811|NCT00112879|Drug|ascorbic acid|
16367812|NCT00112879|Drug|dexamethasone|
16367813|NCT00112879|Drug|thalidomide|
16367814|NCT00112879|Procedure|anti-cytokine therapy|
16367815|NCT00112879|Procedure|antiangiogenesis therapy|
16367816|NCT00112879|Procedure|biological therapy|
16367817|NCT00112879|Procedure|chemotherapy|
16367818|NCT00112879|Procedure|drug resistance inhibition|
16367819|NCT00112879|Procedure|growth factor antagonist therapy|
16367820|NCT00112879|Procedure|non-specific immune-modulator therapy|
16367821|NCT00112866|Drug|cilengitide|Given IV
16367822|NCT00112866|Procedure|therapeutic conventional surgery|Undergo tumor resection
16367823|NCT00112866|Other|pharmacological study|Correlative studies
16367824|NCT00112866|Other|laboratory biomarker analysis|Correlative studies
16367825|NCT00112853|Drug|tipifarnib|Given orally
16367826|NCT00112853|Drug|etoposide|Given orally
16367827|NCT00112840|Drug|CCI-779|CCI-779 is taken IV on days 1, 8, 15, 22 of a 28-day cycle. Dose level is dependent on phase.
16367828|NCT00112840|Drug|Bevacizumab|Bevacizumab is taken IV on Days 1 and 15 of a 28-day cycle. Dose Level determined by phase.
16367829|NCT00112827|Radiation|total marrow irradiation|Undergo irradiation
16367830|NCT00112827|Drug|melphalan|Given IV
16367831|NCT00112827|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
16367832|NCT00112827|Biological|filgrastim|Given IV
16367833|NCT00112827|Genetic|fluorescence in situ hybridization|Correlative studies
16367834|NCT00112827|Genetic|cytogenetic analysis|Correlative studies
16367835|NCT00112827|Drug|cyclophosphamide|Given IV
16367836|NCT00112827|Procedure|autologous-autologous tandem hematopoietic stem cell transplantation|Undergo transplantation
16367837|NCT00112827|Drug|lenalidomide|Given orally
16367838|NCT00112775|Drug|dasatinib|
16367839|NCT00112775|Drug|imatinib mesylate|
16367840|NCT00112749|Biological|infliximab|A single infusion of 1mg/kg will be administered.
16367841|NCT00112749|Other|Clinical Assessment|Medical, psychiatric, and immune evaluation.
16367842|NCT00112749|Other|Self-report questionnaires|Fatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36.
16367843|NCT00112749|Other|Immune Assessment|Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
16367844|NCT00112736|Drug|erlotinib|Given orally
16367845|NCT00112736|Drug|temsirolimus|Given IV
16367846|NCT00112736|Procedure|therapeutic conventional surgery|Undergo surgical resection
16367847|NCT00112736|Other|laboratory biomarker analysis|Correlative studies
16367848|NCT00112736|Other|pharmacological study|Correlative studies
16367849|NCT00112723|Drug|alvocidib|Given IV
16367850|NCT00112710|Drug|carboplatin|
16367851|NCT00112710|Drug|cisplatin|
16367852|NCT00112710|Drug|gemcitabine hydrochloride|
16367853|NCT00112697|Drug|cisplatin|
16367854|NCT00112697|Drug|docetaxel|
16367855|NCT00112697|Drug|fluorouracil|
16367856|NCT00112697|Radiation|radiation therapy|
16367857|NCT00112684|Drug|alvocidib|Given IV
16367858|NCT00112684|Other|pharmacological study|Correlative studies
16367859|NCT00112684|Other|laboratory biomarker analysis|Correlative studies
16367860|NCT00112671|Drug|sorafenib tosylate|Given orally 400mg orally twice daily
16367861|NCT00112671|Other|laboratory biomarker analysis|Correlative studies
16367862|NCT00112658|Drug|fluorouracil|
16367863|NCT00112658|Drug|gemcitabine hydrochloride|
16367864|NCT00112658|Drug|irinotecan hydrochloride|
16367865|NCT00112658|Drug|leucovorin calcium|
16367866|NCT00112658|Drug|oxaliplatin|
16367867|NCT00112645|Biological|anti-thymocyte globulin|
16367868|NCT00112645|Drug|busulfan|
16367869|NCT00112645|Drug|cyclosporine|
16367870|NCT00112645|Drug|melphalan|
16367874|NCT00112645|Procedure|peripheral blood stem cell transplantation|
16367875|NCT00112645|Procedure|umbilical cord blood transplantation|
16367876|NCT00112632|Drug|imatinib mesylate|
16367877|NCT00112632|Procedure|conventional surgery|
16367878|NCT00112632|Procedure|neoadjuvant therapy|
16367879|NCT00112619|Drug|topotecan hydrochloride|Participants receive intraventricular topotecan, .2 mg, administered via an indwelling ventricular reservoir daily for 5 consecutive days during weeks 1 and 3 of the first four weeks of therapy (induction), during weeks 5 and 8 of the next 6 weeks of therapy (consolidation), and during weeks 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, and 51 (maintenance therapy).
16367880|NCT00112593|Drug|fludarabine phosphate|Given IV
16367881|NCT00112593|Radiation|total-body irradiation|Undergo TBI
16367882|NCT00112593|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
16367883|NCT00112593|Drug|cyclosporine|Given IV or PO
16367884|NCT00112593|Drug|mycophenolate mofetil|Given IV or PO
16367885|NCT00112593|Other|laboratory biomarker analysis|Correlative studies
16367886|NCT00112580|Biological|ipilimumab|
16367887|NCT00112567|Drug|fludarabine phosphate|
16367888|NCT00112567|Drug|thiotepa|
16367889|NCT00112567|Procedure|peripheral blood stem cell transplantation|
16367890|NCT00112567|Radiation|radiation therapy|
16367891|NCT00112554|Drug|cytarabine|Given IV
16367892|NCT00112554|Drug|laromustine|Given IV
16367893|NCT00112554|Other|placebo|Given IV
16367894|NCT00112528|Biological|bevacizumab|
16367895|NCT00112528|Drug|gemcitabine hydrochloride|
16367896|NCT00112528|Drug|oxaliplatin|
16367897|NCT00112515|Drug|modafinil|
16367898|NCT00112515|Procedure|cognitive assessment|
16367899|NCT00112515|Procedure|psychosocial assessment and care|
16367900|NCT00112515|Procedure|quality-of-life assessment|
16367905|NCT00112489|Drug|carboplatin|
16367906|NCT00112489|Drug|paclitaxel|
16367907|NCT00112476|Drug|bryostatin 1|Given IV
16367908|NCT00112476|Drug|temsirolimus|Given IV
16367909|NCT00112463|Drug|romidepsin|DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.
16367910|NCT00112437|Drug|Odanacatib|Odanacatib 3 mg, once weekly for 24 months
16367911|NCT00112437|Drug|Odanacatib|Odanacatib 10 mg, once weekly for 24 months
16367912|NCT00112437|Drug|Odanacatib|Odanacatib 25 mg, once weekly for 24 months
16367913|NCT00112437|Drug|Odanacatib|Odanacatib 50 mg, once weekly for 24 months
16367914|NCT00112437|Dietary Supplement|Vitamin D3|Vitamin D3, two 2800 IU weekly throughout the study
16367915|NCT00112437|Dietary Supplement|Calcium Carbonate|Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
16367916|NCT00112437|Drug|Placebo|Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
16367917|NCT00112424|Procedure|Diagnostic cardiac MRI|Routine cardiac MRI done under general anesthesia as pre-operative evaluation.
16367918|NCT00112424|Procedure|Cardiac catheterization|Routine cardiac catheterization prior to Glenn operation.
16367919|NCT00112411|Drug|Bronchodilator|
16367920|NCT00112398|Procedure|Extended interventions by advanced level prehospital providers|may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
16367921|NCT00112385|Drug|Etanercept|Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
16367922|NCT00112385|Drug|Placebo|Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.
16367923|NCT00112372|Drug|Ridaforolimus|10 mg tablet of ridaforolimus administered orally according to one of several different dosing regimens for a four-week treatment cycle.
16367924|NCT00112359|Drug|AZLI 75 mg three times a day (TID)|
16367925|NCT00112359|Drug|Placebo three times a day (TID)|
16367926|NCT00112346|Drug|Cetuximab + platinum + gemcitabine|Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
16367927|NCT00112346|Drug|Platinum + Gemcitabine|Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.
16367928|NCT00112333|Procedure|fMRI|A liquid meal (Ensure 1Kcal/cc) will be infused into the stomach via a nasogastric tube at a rate of 60cc/min till the subject reaches maximal satiety. The amount of liquid meal will differ per subject.
16367929|NCT00112320|Procedure|PVR plus RV remodeling|PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume
16367930|NCT00112320|Procedure|Standard PVR|PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm
16367931|NCT00112307|Procedure|Brachytherapy|
16367932|NCT00112294|Drug|Paclitaxel (Taxane)|IV, 225 mg/m^2
16367933|NCT00112294|Drug|Docetaxel (Taxane)|IV, 75 mg/m^2
16367934|NCT00112294|Drug|Carboplatin|AUC=6, q 3 weeks (6 cycles maximum)
16367935|NCT00112294|Drug|Cetuximab|Intravenous, 400 mg/m^2, initial dose followed by 250 mg/m^2, weekly starting on Week 2
16367936|NCT00112281|Drug|Tilarginine Acetate Injection intravenous infusion|
16367937|NCT00112268|Behavioral|QuitLink (office support system for quit line referral)|
16367988|NCT00111943|Drug|1% tenofovir gel|
16367938|NCT00112255|Behavioral|Practice nurse-led partner notification|
16367939|NCT00112255|Behavioral|Referral to specialist genitourinary clinic|
16367940|NCT00112242|Biological|Melan-A ELA + Montanide|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
16367941|NCT00112242|Biological|Melan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
16367942|NCT00112242|Biological|Melan-A -ELA + NY-ESO-1b + MAGE-A10 peptide + Montanide + CpG|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
16367943|NCT00112242|Biological|Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
16367944|NCT00112242|Biological|Melan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG+ IL-2|"A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months."
16367945|NCT00112229|Biological|group 1|Melan-A analog peptide + CpG + Montanide
16367946|NCT00112229|Biological|group 2|Melan-A natural peptide + CpG + Montanide
16367947|NCT00112229|Biological|group 3|Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
16367948|NCT00112229|Biological|group 4|Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide
16367949|NCT00112216|Biological|Melan-A analog peptide|
16367950|NCT00112216|Biological|FluMa peptide|
16367951|NCT00112216|Biological|Mage-A10 peptide|
16367952|NCT00112216|Biological|SB AS-2 adjuvant|
16367953|NCT00112216|Biological|Montanide adjuvant|
16367954|NCT00112203|Drug|Itopride|
16367955|NCT00112190|Drug|Itopride Hydrochloride|100 mg tid
16367956|NCT00112190|Drug|itopride|100 mg three times daily
16367957|NCT00112177|Drug|Itopride Hydrochloride|
16367958|NCT00112164|Drug|Xigris|
16367959|NCT00112151|Drug|LowT|Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
16367960|NCT00112151|Behavioral|Resistance Training|Weight training 45-60 minutes 3 times per week
16367961|NCT00112151|Drug|Placebo|2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
16367962|NCT00112151|Drug|HighT|High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
16367963|NCT00112138|Drug|gabapentin|
16367964|NCT00112125|Device|OPTIMIZER System|
16367965|NCT00112112|Biological|FluMist|"The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.
~brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm."
16367966|NCT00112112|Biological|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
16367967|NCT00112099|Procedure|Surgery: Splenectomy|Procedure/Surgery: Surgery: Splenectomy
16367968|NCT00112099|Procedure|Surgery: Spleen-preservation|Procedure/Surgery: Surgery: Spleen-preservation
16367969|NCT00112086|Drug|Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)|
16367970|NCT00112073|Drug|bapineuzumab|IV, Q13w
16367971|NCT00112073|Other|placebo|IV Q13w
16367972|NCT00112060|Drug|PT-523 for Injection|
16367973|NCT00112047|Drug|Emtricitabine (FTC)|Capsule containing 200 mg FTC, taken once daily, for 96 weeks
16367974|NCT00112047|Drug|Tenofovir Disoproxil Fumarate (TDF)|Tablet containing 300 mg TDF, taken once daily, for 96 weeks
16367975|NCT00112047|Drug|Efavirenz (EFV)|Tablet containing 600 mg EFV, taken once daily, for 96 weeks
16367976|NCT00112047|Drug|FTC/TDF|Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
16367977|NCT00112047|Drug|FTC/TDF/EFV|Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
16367978|NCT00112047|Drug|Lamivudine/zidovudine|Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks
16367979|NCT00112034|Drug|Methotrexate|
16367980|NCT00112034|Drug|IV methylprednisolone|
16367981|NCT00112021|Drug|pramlintide acetate|
16367982|NCT00112008|Drug|De Novo Administration of Darbepoetin Alfa|Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL
16367983|NCT00111995|Drug|Aranesp®|
16367984|NCT00111982|Biological|Liatermin|Liatermin
16367985|NCT00111969|Device|Celacade™ system|
16367986|NCT00111956|Drug|Etanercept|
16367987|NCT00111956|Drug|Placebo|
16367990|NCT00111917|Drug|Infliximab|anti-TNF
16367991|NCT00111917|Other|Placebo|Placebo infusion
16367992|NCT00111904|Drug|paclitaxel-loaded polymeric micelle|
16367993|NCT00111891|Drug|niacin (+) laropiprant|
16367994|NCT00111891|Drug|Comparator: placebo (unspecified)|
16367995|NCT00111878|Drug|MEDI-534|
16367996|NCT00111865|Behavioral|Aerobic Exercise Training|The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention.
16367997|NCT00111852|Drug|Desmoteplase|Desmoteplase 90 mcg/kg, intravenous administration.
16367998|NCT00111852|Drug|Desmoteplase|Desmoteplase 125 mcg/kg, intravenous administration.
16367999|NCT00111852|Drug|Placebo|Dose-Match Placebo, intravenous administration.
16368000|NCT00111839|Drug|Pemetrexed|Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
16368001|NCT00111839|Drug|Matuzumab|Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.
16368002|NCT00111826|Device|Celacade™ system|
16368003|NCT00111813|Drug|vorinostat|Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
16368004|NCT00111813|Drug|bortezomib|Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
16368005|NCT00111800|Drug|Placebo|Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368006|NCT00111800|Drug|DEN 2.5 mg|DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368007|NCT00111800|Drug|DEN 7.5 mg|DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368008|NCT00111800|Drug|DEN 15 mg|DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368009|NCT00111800|Drug|DEN 30 mg|DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368010|NCT00111800|Drug|DEN 45 mg|DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
16368011|NCT00111787|Drug|Lapatinib|Daily-monotherapy [1500 milligrams (mg)] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
16368012|NCT00111787|Drug|Paclitaxel|Weekly (80mg/m^2) combination therapy (with daily Lapatinib) for 12 weeks
16368013|NCT00111774|Drug|ABX-EGF|
16368014|NCT00111761|Drug|Irinotecan|Part 1: 125 mg/m^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m^2 IV infusion every other week until disease progression or unable to tolerate.
16368015|NCT00111761|Biological|Panitumumab|Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.
16368016|NCT00111761|Drug|5-Fluorouracil|Part 1: IV bolus 500 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m^2 and infusional 2400-3000 mg/m^2 over 46 hours once every other week until disease progression or unable to tolerate.
16368017|NCT00111761|Drug|Leucovorin|Part 1: IV bolus 20 mg/m^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m^2 every other week until disease progression or unable to tolerate.
16368018|NCT00111748|Drug|Velcade, Thalidomide, Dexamethasone|"Dosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14
~This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit."
16368019|NCT00111735|Drug|Thyroxine|
16368020|NCT00111722|Drug|MK0462, rizatriptan benzoate / Duration of Treatment -1day|
16368021|NCT00111722|Drug|Comparator: placebo / Duration of Treatment - 1 day|
16368022|NCT00111709|Drug|MK0462, rizatriptan benzoate / Duration of Treatment -1 day|
16368023|NCT00111709|Drug|Comparator: placebo / Duration of Treatment - 1 day|
16368024|NCT00111696|Biological|MEDI-522|Supplied at a concentration of 50 mg/mL in both 2 mL and 10mL vials
16368025|NCT00111683|Drug|MK0457|
16368026|NCT00111670|Drug|DPP-IV Inhibitor|Escalating doses po bid or qd
16368027|NCT00111670|Drug|Placebo|po bid or qd
16368028|NCT00111657|Biological|Pegloticase|8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5
16368029|NCT00111644|Drug|Ceftriaxone|1000mg iv daily
16368030|NCT00111644|Drug|beta-lactam|750mg iv q 23h for 3-14 days
16368031|NCT00111644|Drug|beta-lactam|1500mg iv q 12h for 3-14 days
16368032|NCT00111631|Drug|DPP-IV Inhibitor|Escalating doses po bid
16368033|NCT00111631|Drug|Metformin|As prescribed
16368034|NCT00111631|Drug|Placebo|po bid
16368035|NCT00111618|Drug|AS1404 (DMXAA)|
16368036|NCT00111605|Biological|HIV-1 gag DNA|A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
16368037|NCT00111605|Biological|HIV-1 gag DNA plus IL-12 DNA adjuvant|Injection IL-12 DNA adjuvant intramuscularly into the deltoid
16368038|NCT00111605|Biological|CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)|A 1 mL intramuscular injection in the deltoid
16368039|NCT00111605|Biological|Sodium chloride injection (0.9%)|"All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.
~Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273."
16368040|NCT00111592|Procedure|current usual care|current usual care
16373629|NCT00083538|Drug|Cisplatinum|
16368041|NCT00111592|Procedure|treatment protocol with clear indications for therapy|treatment protocol with clear indications for therapy
16368042|NCT00111579|Biological|CAIV-T|A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.
16368043|NCT00111579|Other|TIV|A total vol. of 0.25 will be administered intramuscularly for each of two doeses.
16368044|NCT00111566|Drug|eptifibatide|
16368045|NCT00111553|Biological|Leish-111f + MPL-SE vaccine|
16368046|NCT00111540|Drug|exenatide|subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
16368047|NCT00111527|Other|Optimized echo-guided CRT pacing|Echo-TDI guided VV-delay optimization
16368048|NCT00111527|Other|normal RV pacing|PM or ICD implant according to patient indication
16368049|NCT00111514|Biological|Leish-111f + MPL-SE vaccine|
16368050|NCT00111501|Behavioral|Tobacco Use Disorder|Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component
16368051|NCT00111501|Behavioral|Standard Web-based intervention|General psychoeducational Web-based smoking cessation intervention
16368052|NCT00111488|Device|Flex 4 and Generator|
16368053|NCT00111475|Drug|Romiplostim|Administered by subcutaneous injection
16368054|NCT00111475|Drug|Placebo|Administered by subcutaneous injection
16368055|NCT00111462|Drug|Darbepoetin alfa|
16368056|NCT00111449|Drug|Etanercept|
16368057|NCT00111436|Drug|Etanercept|Enbrel 50 mg once weekly or 50 mg twice weekly
16368058|NCT00111423|Drug|Pegsunercept (PEG sTNF-RI)|
16368059|NCT00111410|Drug|Anakinra (r-metHuIL-1ra)|
16368060|NCT00111397|Procedure|Cytokine therapy|
16368061|NCT00111397|Drug|Interferon Gamma, GM-CSF|
16368062|NCT00111371|Drug|Levodopa|
16368063|NCT00111358|Behavioral|Lifestyle Modification|
16368064|NCT00111358|Other|No lifestyle modification|
16368065|NCT00111345|Drug|Anthracyclines|3x12 mg/qm
16368066|NCT00111345|Drug|liposomal daunorubicin|3x80 mg/qm
16368067|NCT00111345|Drug|2-CDA|2x6 mg/qm
16368068|NCT00111345|Drug|AI|AI
16368069|NCT00111332|Behavioral|Progressive resistance and aerobic training|
16368070|NCT00111319|Drug|bortezomib|
16368071|NCT00111306|Drug|epratuzumab|
16368072|NCT00111280|Drug|TMC125|
16368073|NCT00111267|Behavioral|vitamin B12 supplementation|
16368074|NCT00111267|Behavioral|vitamin B12 + folic acid combined supplementation|
16368075|NCT00111254|Procedure|Microdermabrasion|Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device).
16368076|NCT00111241|Drug|aromatase inhibitors (letrozole, anastrozole)|Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study
16368077|NCT00111228|Device|Guardian RT|
16368078|NCT00111228|Device|SMBG only|SMBG only
16368079|NCT00111215|Drug|Tranexamic Acid|
16368080|NCT00111215|Drug|Desmopressin Acetate|
16368081|NCT00111189|Drug|Placebo|Placebo every 4 wk up to 24 mo
16368082|NCT00111189|Drug|Paliperidone Palmitate|25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
16368083|NCT00111176|Device|Endovascular repair|Endovascular repair.
16368084|NCT00111176|Procedure|Surgical|Surgical endovascular repair
16368085|NCT00111163|Drug|sulfadoxine-pyrimethamine with artesunate|
16368086|NCT00111163|Drug|amodiaquine with artesunate|
16368087|NCT00111163|Drug|chlorproguanil-dapsone|
16368088|NCT00111150|Drug|Tenofovir Disoproxil Fumarate 300 mg daily|
16368089|NCT00111137|Drug|rHuEPO|rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
16368090|NCT00111137|Drug|Darbepoetin alfa|4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
16368091|NCT00111124|Drug|Enbrel®|
16368092|NCT00111111|Drug|Etanercept|
16368093|NCT00111098|Drug|Darbepoetin Alfa|QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg.
16368094|NCT00111085|Drug|Clazosentan 1 mg/h|Subjects receive intravenous clazosentan at a rate of 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
16368095|NCT00111085|Drug|Clazosentan 5 mg/h|Subjects receive intravenous clazosentan at a rate of 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
16368096|NCT00111085|Drug|Clazosentan 15 mg/h|Subjects receive intravenous clazosentan at a rate of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
16368097|NCT00111085|Drug|Placebo|Subjects receive intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
16368098|NCT00111046|Drug|Ibuprofen|
16368099|NCT00111046|Drug|Tramadol|
16368100|NCT00111020|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC
16368101|NCT00111007|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
16368102|NCT00111007|Drug|Carboplatin/Paclitaxel|Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
16368103|NCT00111007|Drug|Placebo|Placebo, 2 tablets bid Study Days 2-19
16368104|NCT00110994|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
16368105|NCT00110994|Drug|Placebo|Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
16368106|NCT00110994|Drug|Dacarbazine|Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1
16368107|NCT00110981|Device|NB-UVB|Three times a week (TIW) for 12 weeks
16368108|NCT00110981|Drug|Etanerept|50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
16368109|NCT00110981|Drug|Etanercept|50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
16368110|NCT00110968|Drug|Itopride hydrochloride|
16368111|NCT00110955|Drug|Darbepoetin alfa|Q3W 300 mcg darbepoetin alfa
16368112|NCT00110955|Drug|Placebo|Q3W dosing of placebo
16368113|NCT00110942|Drug|Systemic AMG 108|300 mg SC AMG 108 Q4W for 3 doses
16368114|NCT00110942|Other|Placebo|SC placebo injection Q4W for 3 doses
16368115|NCT00110929|Drug|AMG 073|
16368116|NCT00110916|Drug|Intra-articular metHuIL-1ra (anakinra)|anakinra
16368117|NCT00110916|Drug|placebo|placebo
16368118|NCT00110903|Drug|Etanercept Liquid|
16368119|NCT00110890|Drug|cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
16368120|NCT00110890|Other|Standard of care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
16368121|NCT00111072|Drug|dexamethasone 0.01% solution|
16368122|NCT00110877|Drug|LPV/rtv|One 400mg LPV tablet twice daily with 100mg RTV
16368123|NCT00110877|Drug|TMC114/rtv|Two 300mg TMC114 tablets twice daily with 100mg RTV
16368124|NCT00110864|Drug|PN2034|
16368125|NCT00110864|Drug|Insulin|
16368126|NCT00110851|Drug|rosiglitazone|
16368127|NCT00110851|Drug|metformin|
16368128|NCT00110851|Drug|PN2034|
16368129|NCT00110838|Procedure|Supplementation with fish oil versus placebo|
16368130|NCT00110825|Behavioral|Cognitive Behavior Therapy|extended treatment with cognitive behavior therapy
16368131|NCT00110812|Drug|IL-2|7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
16368132|NCT00110799|Drug|SB497115|Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
16368133|NCT00110799|Other|Placebo|Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
16368134|NCT00110786|Biological|Ragweed MATAMPL|
16368135|NCT00110773|Drug|S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)|S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
16368136|NCT00110773|Drug|Placebo Peel|Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
16368137|NCT00110760|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel was composed of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine and was applied topically. S-Caine Peel was applied with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
16368138|NCT00110760|Drug|Placebo Peel|Placebo Peel applied topically with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
16368139|NCT00110747|Drug|S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)|S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
16368140|NCT00110747|Drug|Placebo Peel|Peel was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
16368141|NCT00110734|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|
16368142|NCT00110721|Drug|GM-CT-01 plus 5-Fluorouracil|Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.
16368143|NCT00110708|Drug|Oralgam (human immunoglobulin)|
16368144|NCT00110695|Drug|Nanoparticle albumin bound paclitaxel followed by FEC|Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. [or if given with trastuzumab 75 mg/m2 IV over 15 min.]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days
16368145|NCT00110682|Drug|Imiquimod used as an adjunct to cryotherapy|
16368146|NCT00110669|Drug|Prednisone|"Prednisone and dummy preparations for this study will be obtained from Frank's Pharmacy in Ocala, FL and will be supplied as a tablet containing 2.5mg, 5mg, 10mg, 20mg or 50mg Prednisone. Inactive dummy pills of similar look/taste will be supplied to maintain blinding."
16368147|NCT00110656|Other|Observations|This is a non-interventional study- only observational.
16368148|NCT00110643|Device|CoolTouch II laser|
16368149|NCT00110630|Behavioral|10-week smoking cessation group therapy combined with NicoDerm CQ|
16368150|NCT00110617|Drug|Deferasirox (ICL670)|Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
16368151|NCT00110617|Drug|Deferoxamine (DFO)|Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.
16368152|NCT00110604|Behavioral|folic acid (0.8 mg)|
16368153|NCT00110591|Drug|PRO 140|Monoclonal antibody to CCR5
16368154|NCT00110578|Procedure|Adoptive transfer of HIV-specific CD8+ T cells|
16368155|NCT00110578|Drug|Aldesleukin|
16368156|NCT00110565|Device|Pulsed magnetic field pad|
16368157|NCT00110552|Drug|Salvia officinalis (sage)|oral dosage
16368158|NCT00110539|Behavioral|Complementary and alternative medicine education|
16368159|NCT00110526|Genetic|Ad.hIL-12|Ad.hIL-12 intraprostatic injection IND
16368160|NCT00110513|Biological|Recombinant human antithrombin (rhAT)|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
16368163|NCT00110474|Drug|Glucosamine sulfate|
16368164|NCT00110474|Drug|Acetaminophen|
16368165|NCT00110461|Drug|Aripiprazole|Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
16368166|NCT00110461|Drug|Aripiprazole|Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
16368167|NCT00110461|Drug|placebo|Placebo tablet
16368168|NCT00110448|Drug|Aspirin|Aspirin 81 mg or 100 mg per day
16368169|NCT00110448|Drug|No aspirin|No aspirin use
16368170|NCT00110435|Drug|MK0653A, ezetimibe (+) simvastatin|
16368171|NCT00110435|Drug|Duration of Treatment: 4 wk placebo run in then 6 wk active|
16368172|NCT00110435|Drug|Comparator: atorvastatin|
16368173|NCT00110422|Drug|Irbesartan|Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
16368174|NCT00110422|Drug|Hydrochlorothiazide|Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
16368175|NCT00110409|Behavioral|Asthma Education in Adults|The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.
16368176|NCT00110409|Behavioral|Standard Emergency Room Asthma Education|Participants will receive standard emergency room education about asthma.
16368177|NCT00110396|Biological|Interferon-beta-1a FBS-free/HSA-free|Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
16368178|NCT00110383|Behavioral|School-Based Supervised Asthma Therapy|Child's inhaled steroid use supervised daily at school
16368179|NCT00110370|Drug|Lispro Mixture Therapy|
16368180|NCT00110370|Drug|Glargine Basal-Bolus Therapy|
16368181|NCT00110357|Drug|Cetuximab + Irinotecan|Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
16368182|NCT00110357|Drug|Cetuximab + Irinotecan|Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
16368183|NCT00110344|Drug|Nexavar (Sorafenib, BAY43-9006)|Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
16368184|NCT00110344|Drug|Placebo|Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)
16368185|NCT00110318|Procedure|Manual therapy and therapeutic exercise|
16368186|NCT00110318|Procedure|Corticosteroid injections|
16368187|NCT00110305|Drug|TMC278 25 mg|TMC278 25 mg tablet will be administered once daily.
16368188|NCT00110305|Drug|TMC278 75 mg|TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.
16368189|NCT00110305|Drug|TMC278 150 mg|TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.
16368190|NCT00110305|Drug|Efavirenz|Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.
16368191|NCT00110305|Drug|Non-nucleoside reverse transcriptase inhibitor (NRTIs)|Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.
16368192|NCT00110292|Behavioral|Age-specific parenting newsletters and developmental toys|
16368193|NCT00110292|Behavioral|Parent-completed Ages & Stages Questionnaires|
16368194|NCT00110292|Behavioral|Clinic-based distribution of children's books|
16368195|NCT00110279|Biological|H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)|Live attenuated H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
16368196|NCT00110266|Drug|Deferasirox|20 mg/kg/day over one year in patients with MDS
16368197|NCT00110253|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel is composed of a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine, which was applied topically. The S Caine Peel was applied at approximately 1 mm in thickness and remained on the treatment area for 30 or 60 minutes
16368198|NCT00110240|Drug|vildagliptin|
16368199|NCT00110227|Behavioral|12-week Tai Chi Program|24 tai chi sessions. 2 sessions/week for 12 weeks.
16368200|NCT00110227|Behavioral|12-week Education Program|24 Educational sessions. 2 sessions/week for 12 weeks.
16368201|NCT00110214|Drug|docetaxel|Given IV
16368202|NCT00110214|Other|placebo|Given IV
16368203|NCT00110214|Drug|prednisone|Given orally
16368204|NCT00110214|Biological|bevacizumab|Given IV
16368205|NCT00110214|Other|laboratory biomarker analysis|Correlative studies
16368206|NCT00110201|Drug|Nesiritide|
16368207|NCT00110188|Drug|ridaforolimus|
16368208|NCT00110162|Drug|antiandrogen therapy|
16368209|NCT00110162|Drug|releasing hormone agonist therapy|
16368210|NCT00110162|Procedure|orchiectomy|
16368211|NCT00110149|Biological|rituximab|
16368212|NCT00110149|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16368213|NCT00110136|Drug|St. John's Wort|St. John's Wort 300mg tablet three times per day
16368214|NCT00110123|Drug|fotemustine|
16368215|NCT00110123|Drug|isolated perfusion|
16368223|NCT00110084|Drug|Gemcitabine|1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
16368224|NCT00110084|Drug|Paclitaxel protein-bound particles for injectable suspension (albumin-bound)|125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
16368225|NCT00110071|Drug|fludarabine phosphate|Given IV
16368226|NCT00110071|Procedure|peripheral blood stem cell transplantation|Undergo transplantation (infusion of autologous or syngeneic PBSC via central line)
16368227|NCT00110071|Radiation|iodine I 131 tositumomab|Given IV (dosimetric dose) or via central line (therapeutic dose)
16368228|NCT00110071|Other|laboratory biomarker analysis|Correlative studies
16368229|NCT00110071|Other|flow cytometry|Correlative studies
16368230|NCT00110071|Genetic|polymerase chain reaction|Correlative studies
16368231|NCT00110058|Biological|recombinant interferon alfa|
16368232|NCT00110058|Biological|therapeutic allogeneic lymphocytes|
16368233|NCT00110058|Drug|cyclosporine|
16368234|NCT00110058|Drug|fludarabine phosphate|
16368235|NCT00110058|Drug|imatinib mesylate|
16368236|NCT00110058|Drug|mycophenolate mofetil|
16368237|NCT00110058|Procedure|peripheral blood stem cell transplantation|
16368238|NCT00110058|Radiation|radiation therapy|
16368239|NCT00110045|Drug|caspofungin acetate|
16368240|NCT00110032|Drug|EF5|Given IV
16368241|NCT00110032|Procedure|conventional surgery|Undergo surgery
16368242|NCT00110032|Procedure|positron emission tomography|Undergo PET
16368243|NCT00110032|Radiation|fluorine F 18 EF5|Given IV
16368244|NCT00110032|Other|pharmacological study|Correlative studies
16368245|NCT00110019|Drug|Carboplatin|Given IV
16368246|NCT00110019|Other|Laboratory Biomarker Analysis|Correlative studies
16368247|NCT00110019|Drug|Paclitaxel|Given IV
16368248|NCT00110019|Other|Pharmacological Study|Correlative studies
16368249|NCT00110019|Other|Placebo|Given PO
16368250|NCT00110019|Drug|Sorafenib Tosylate|Given PO
16368251|NCT00110006|Biological|rituximab|Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
16368252|NCT00110006|Drug|cyclophosphamide|Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
16368253|NCT00110006|Drug|doxorubicin hydrochloride|Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
16368254|NCT00110006|Drug|prednisone|Oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
16368255|NCT00110006|Drug|vincristine sulfate|Vincristine IV over 5 minutes on day 1. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
16368256|NCT00110006|Procedure|positron emission tomography|Beginning 1 hour after receiving fludeoxyglucose F 18, patients undergo whole-body positron emission tomography (PET) scanning. Patients undergo repeat ^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP.
16368257|NCT00110006|Radiation|fludeoxyglucose F 18|Patients receive fludeoxyglucose F 18 (^18FDG) IV.
16368258|NCT00109993|Biological|alemtuzumab|alemtuzumab IV over 2 hours on days 4-6, 18, and 32
16368259|NCT00109993|Drug|methylprednisolone|methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
16368260|NCT00109993|Drug|tacrolimus|tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease
16368261|NCT00109967|Biological|rituximab|375 mg/m^2 Given IV
16368262|NCT00109967|Drug|temsirolimus|25 mg given IV
16368263|NCT00109954|Drug|cisplatin|
16368264|NCT00109954|Radiation|brachytherapy|
16368265|NCT00109954|Radiation|yttrium Y 90 glass microspheres|
16368266|NCT00109941|Biological|opioid growth factor|OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
16368267|NCT00109941|Biological|metenkephalin, OGF-opioid growth factor|OGF given in saline iv 250 ug/kg weekly
16368268|NCT00109928|Drug|cisplatin|
16368269|NCT00109928|Drug|etoposide|
16368270|NCT00109928|Drug|gemcitabine|
16368271|NCT00109928|Drug|methylprednisolone|
16368272|NCT00109889|Procedure|magnetic resonance imaging|magnetic resonance imaging (MRI)
16368273|NCT00109889|Procedure|positron emission tomography|positron emission tomography (PET)
16368274|NCT00109876|Procedure|Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation|Undergo RFA
16368275|NCT00109863|Biological|hu14.18-IL2 fusion protein|
16368276|NCT00109850|Biological|cetuximab|400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
16368277|NCT00109850|Drug|cisplatin|30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
16368278|NCT00109850|Drug|irinotecan hydrochloride|65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
16368279|NCT00109850|Radiation|radiation therapy|The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
16368280|NCT00109837|Biological|filgrastim|As needed per physician discretion
16368281|NCT00109837|Drug|cyclophosphamide|Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1
16368282|NCT00109837|Drug|cytarabine|Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13
16368283|NCT00109837|Drug|daunorubicin|Induction: 60 mg/m2/d; IV; days 1, 2, and 3
16368284|NCT00109837|Drug|dexamethasone|Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28
16368285|NCT00109837|Drug|doxorubicin|Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22
16368286|NCT00109837|Drug|leucovorin|For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC < 3,000
16368287|NCT00109837|Drug|mercaptopurine|Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs
16368288|NCT00109837|Drug|methotrexate|Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs
16368289|NCT00109837|Drug|mitoxantrone|Induction 2: 80 mg/m2; IV; day 3
16368290|NCT00109837|Drug|Asparaginase|Induction: 2,000 IU/m2; IM or IV; day 15
16368291|NCT00109837|Drug|prednisone|Induction: 60 mg/m2/d; PO or IV; days 1-35
16368292|NCT00109837|Drug|thioguanine|Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14
16368293|NCT00109837|Drug|vincristine|Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22
16368294|NCT00109837|Radiation|radiation therapy|For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.
16368295|NCT00109837|Drug|allopurinol|300 mg/d PO Days 1-7
16368296|NCT00109837|Drug|bactrim|1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone
16368297|NCT00109824|Drug|decitabine|Given IV
16368298|NCT00109824|Drug|valproic acid|Given PO
16368299|NCT00109824|Other|pharmacological study|Correlative studies
16368300|NCT00109824|Other|laboratory biomarker analysis|Correlative studies
16368301|NCT00109811|Biological|PSA:154-163(155L) peptide vaccine|Given subcutaneously
16368302|NCT00109811|Biological|incomplete Freund's adjuvant|Given subcutaneously
16368303|NCT00109811|Other|laboratory biomarker analysis|Correlative studies
16368304|NCT00109798|Drug|temozolomide|Patient will take drug on day 1-5 of 28 day schedule
16368305|NCT00109798|Drug|topotecan hydrochloride|Patient will have IV on days 2-6 on a 28-day schedule
16368306|NCT00109785|Procedure|positron emission tomography|
16368307|NCT00109785|Radiation|fludeoxyglucose F 18|
16368308|NCT00109785|Radiation|iodine I 124 iododeoxyuridine|
16368309|NCT00109772|Drug|lenalidomide|Two 5 mg capsules taken one time per day
16368310|NCT00109772|Drug|Placebo|Two placebo capsules taken one time per day
16368311|NCT00109759|Biological|RagweedMATAMPL|
16368312|NCT00109759|Drug|Placebo|
16368313|NCT00109746|Dietary Supplement|chromium picolinate|HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
16368314|NCT00109733|Biological|recombinant human growth hormone|0.005 mg/kg/day for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
16368315|NCT00109733|Biological|recombinant human growth hormone|0.010 mg/kg/day for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
16368316|NCT00109720|Behavioral|Diabetes Self-Management Consultant|services of a Diabetes Self-Management Consultant
16368317|NCT00109720|Behavioral|Enhanced Usual Care Control Group|Usual care plus results of metabolic assessments obtained during the study
16368318|NCT00109707|Drug|Nilotinib|
16368319|NCT00109681|Drug|Iloprost Inhalation Solution (Ventavis)|
16368320|NCT00109668|Drug|beclomethasone dipropionate (QVAR)|
16368321|NCT00109655|Biological|Oncolytic adenovirus (serotype 5) - CG0070|Intravesical administration of CG0070 (in suspension) directly into the bladder
16368322|NCT00109629|Drug|VRC-HIVDNA016-00-VP|
16368323|NCT00109629|Drug|VRC-HIVADV014-00|
16368324|NCT00109616|Behavioral|Newborn skin cleansing with 0.25% chlorhexidine solution|
16368325|NCT00109616|Behavioral|Cleansing of umbilical cord with soap and water solution|
16368326|NCT00109616|Behavioral|Cleansing of umbilical cord with 4% chlorhexidine|
16368327|NCT00109603|Drug|Tenofovir disoproxil fumarate|
16368328|NCT00109590|Drug|Didanosine, enteric-coated|once daily
16368329|NCT00109590|Drug|Lopinavir/ritonavir|twice daily
16368330|NCT00109590|Drug|Nevirapine|single-dose at the onset of labor
16368331|NCT00109590|Drug|Zidovudine|twice daily
16368332|NCT00109577|Drug|MCN36 (nutritional supplement)|nutritional supplement
16368333|NCT00109577|Drug|Placebo|nutritional supplement
16368334|NCT00109564|Drug|ispronicline (nicotinic acetylcholine receptor agonist)|
16368335|NCT00109551|Drug|zinc sulphate dietary supplement|
16368336|NCT00109551|Drug|iron sulphate-folic acid dietary supplement|
16368337|NCT00109538|Drug|Lonafarnib|200 mg twice daily (BID, ie, approximately 12 hours apart with food), oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
16368338|NCT00109538|Other|Placebo|BID, oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
16368339|NCT00109512|Drug|NBI-56418 (GnRH antagonist)|
16368340|NCT00109512|Drug|placebo|
16368341|NCT00109499|Drug|AdGVPEDF.11D|
16368342|NCT00109486|Drug|GW685698X|
16373630|NCT00083538|Drug|Adriamycin|
16368343|NCT00109473|Drug|growth hormone|Nutropin AQ 0.075mg/kg/day subcutaneously daily
16368344|NCT00109473|Drug|cortecosteroid|As prescribed by the referring gastroenterologist
16368345|NCT00109460|Behavioral|Tobacco Use Disorder|
16368346|NCT00109421|Behavioral|Project ÒRÉ|Community-based adolescent social network HIV/STI intervention tailored to African American culture
16368347|NCT00109408|Drug|Methotrexate|7.5-20mg po weekly
16368348|NCT00109408|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
16368349|NCT00109395|Drug|Lorazepam|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
16368350|NCT00109395|Drug|Midazolam|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
16368351|NCT00109395|Drug|Lorazepam CI|Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
16368352|NCT00109382|Drug|Aspirin|
16368353|NCT00109382|Drug|Clopidogrel|
16368354|NCT00109382|Drug|Simvastatin|
16368355|NCT00109369|Other|Information and decision support for providers and patients|Laboratory-based decision support, reminders, and population report cards.
16368356|NCT00109356|Drug|AQ4N (Chemotherapy)|
16368357|NCT00109343|Biological|Comparator: ProQuad™ (V221)|0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
16368358|NCT00109343|Biological|Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)|0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
16368359|NCT00109330|Biological|Combined diphtheria, tetanus, acellular pertussis vaccine|
16368360|NCT00109317|Drug|Raptiva (efalizumab)|
16368361|NCT00109304|Biological|VEE 3526|
16368362|NCT00109291|Drug|Placebo|
16368363|NCT00109291|Drug|peginesatide|
16368364|NCT00109278|Biological|V205C, measles, mumps, and rubella virus vaccine live|
16368365|NCT00109278|Biological|Comparator: Measles, Mumps, and Rubella Virus Vaccine Live|
16368366|NCT00109265|Drug|Erlotinib HCl (OSI-774)|
16368367|NCT00109252|Drug|Raptiva (efalizumab)|
16368368|NCT00109239|Drug|rhuMAb VEGF (Bevacizumab)|
16368369|NCT00109226|Drug|Avastin (Bevacizumab)|
16368370|NCT00109213|Procedure|Lumbar Laminectomy with Instrumented Pedicle Screw Fusion|Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
16368371|NCT00109213|Procedure|Lumbar Laminectomy|Removal of bone to decompress spinal nerves
16368372|NCT00109200|Drug|Xolair (omalizumab)|
16368373|NCT00109187|Drug|Xolair (omalizumab)|
16368375|NCT00109161|Drug|Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)|
16368376|NCT00109148|Drug|MK0364|
16368377|NCT00109135|Drug|taranabant|
16368378|NCT00109122|Biological|zoster vaccine live (Oka/Merck)|
16368379|NCT00109122|Biological|Comparator: placebo (unspecified)|
16368380|NCT00109109|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months|
16368381|NCT00109096|Drug|Pemetrexed|
16368382|NCT00109083|Drug|RWJ-333369|
16368383|NCT00109070|Drug|Avastin (bevacizumab)|
16368384|NCT00109057|Drug|Avastin (bevacizumab)|
16368385|NCT00109044|Drug|Escitalopram|
16368386|NCT00109031|Drug|palifermin|Administered as one daily intravenous bolus.
16368387|NCT00109031|Radiation|Total Body Irradiation|To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
16368388|NCT00109031|Drug|Cyclophosphamide|Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
16368389|NCT00109031|Drug|Etoposide|Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
16368390|NCT00109031|Drug|Placebo|Administered as one daily intravenous bolus.
16368391|NCT00109005|Drug|Revlimid|oral dose (1 capsule) 25 mg per day 7 days a week for cohort 1 oral dose (1 capsule) 5 mg per day 7 days a week for cohort 2
16368392|NCT00108992|Drug|Diclofenac, topical|
16368393|NCT00108979|Drug|Escitalopram|
16368394|NCT00108953|Drug|Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin|Multi kinase inhibitor plus Chemotherapy
16368395|NCT00108953|Drug|Doxorubicin/Placebo|Chemotherapy plus Placebo
16368396|NCT00108927|Behavioral|TRANSLATE|
16368397|NCT00108914|Drug|GW685698X|
16368398|NCT00108901|Behavioral|Aerobic exercise program|Vigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of >150 bpm average HR each day and attending at least 80% of sessions (4 days/week).
16368399|NCT00108875|Biological|Survivin peptide vaccine|
16368400|NCT00108862|Other|Strategy: Immediate ART|The intervention is the strategy of initiating antiretroviral therapy (ART) after approximately 2 weeks of rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is efavirenz (EFV) 600 mg (1 tablet orally), emtricitabine (FTC) 200 mg (1 capsule orally), and tenofovir disoproxil fumarate (TDF) 300 mg (1 tablet orally) daily. Substitutions with other locally available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
16368401|NCT00108862|Other|Strategy: Deferred ART|The intervention is the strategy of initiating ART either after 8-12 weeks of RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is EFV 600 mg (1 tablet orally), FTC 200 mg (1 capsule orally), and TDF 300 mg (1 tablet orally) daily. Initiation outside of these windows, on a case by case basis, is permitted at the discretion of the site investigator. Substitutions with other locally available U.S. FDA-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
16368405|NCT00108810|Drug|Transdermal Ketoprofen Patch with CHADD|12 hours patch application for 28 days
16368406|NCT00108810|Drug|Placebo transdermal patch|12 hours application for 28 days
16368407|NCT00108797|Drug|eptacog alfa (activated)|
16368408|NCT00108797|Drug|Feiba VH|
16368409|NCT00108784|Behavioral|Reduced-energy-density diet|
16368410|NCT00108771|Drug|ZR-02-01 Fentanyl Transdermal Matrix Patch|Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.
16368411|NCT00108771|Drug|Placebo Patch|Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
16368412|NCT00108758|Drug|activated recombinant human factor VII|
16368413|NCT00108745|Other|Clinical Observation|Undergo observation
16368414|NCT00108745|Other|Laboratory Biomarker Analysis|Correlative studies
16368415|NCT00108745|Drug|Paclitaxel|Given IV
16368416|NCT00108745|Drug|Paclitaxel Poliglumex|Given IV
16368417|NCT00108745|Procedure|Quality-of-Life Assessment|Ancillary studies
16368418|NCT00108732|Drug|Bicalutamide|Given orally
16368419|NCT00108732|Drug|Goserelin Acetate|Given SC
16368420|NCT00108732|Biological|Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine|Given SC
16368421|NCT00108732|Biological|Recombinant Vaccinia-TRICOM Vaccine|Given SC
16368422|NCT00108732|Biological|Sargramostim|Given SC
16368423|NCT00108706|Drug|Candesartan|
16368424|NCT00108667|Drug|IV Levodopa|
16368425|NCT00108667|Drug|Talampanel|
16368426|NCT00108654|Drug|VRC-HIVADV014-00-VP|
16368427|NCT00108628|Behavioral|Imagery Rehearsal|IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
16368428|NCT00108628|Behavioral|Sleep and Nightmare Management|This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
16368429|NCT00108615|Drug|Metformin|
16368430|NCT00108615|Drug|Pioglitazone|
16368431|NCT00108615|Drug|Metformin|
16368432|NCT00108615|Drug|Pioglitazone|
16368433|NCT00108615|Radiation|CT scans|To measure changes in adipose tissue volumes
16368434|NCT00108615|Procedure|Oral glucose tolerance test|To detect a change in glucose tolerance
16368435|NCT00108602|Drug|acetazolamide|
16368436|NCT00108589|Drug|S-adenosylmethionine|
16368437|NCT00108576|Drug|Divalproex|anticonvulsant; mood stabilizer
16368438|NCT00108576|Other|placebo|Look-a-like placebo
16368439|NCT00108563|Drug|Citalopram or Placebo|
16368440|NCT00108550|Drug|gabapentin|Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial
16368441|NCT00108550|Drug|Inert placebo|Inactive placebo capsule, one capsule on Day 1 with daily or weekly increase to 9 capsules daily by Week 5 of the 12-week trial
16368442|NCT00108537|Drug|bupropion and transdermal patch|
16368443|NCT00108537|Drug|transdermal patch and nicotine inhaler|
16368444|NCT00108524|Behavioral|Low carbohydrate ketogenic diet|A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
16368445|NCT00108524|Drug|Orlistat|In addition to the low fat diet, Orlistat is taken 3 times daily.
16368446|NCT00108524|Behavioral|Low-fat diet|Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake
16368447|NCT00108511|Drug|Gemfibrozil|
16368448|NCT00108498|Drug|mirtazapine|
16368449|NCT00108485|Drug|Extended release niacin|Extended release niacin 1500-2000mg once daily
16368450|NCT00108485|Other|Placebo|Placebo tablets
16368451|NCT00108459|Behavioral|Low Carbohydrate Diet|
16368452|NCT00108446|Drug|dextromethorphan|
16368453|NCT00108446|Drug|naloxone|
16368454|NCT00108446|Drug|fentanyl|
16368455|NCT00108446|Drug|lidocaine|
16368456|NCT00108433|Drug|Cefazolin IV|
16368457|NCT00108433|Drug|Linezolid IV|
16368458|NCT00108433|Drug|Vancomycin (IV)|
16368459|NCT00108420|Drug|Prazosin|
16368460|NCT00108407|Behavioral|Integrated Cognitive Behavioral Therapy|
16368461|NCT00108407|Behavioral|Twelve Step Facilitation Therapy|
16368462|NCT00108394|Drug|pamidronate|
16368463|NCT00108381|Behavioral|tailored cognitive behavior therapy|tailored psychological treatment
16368464|NCT00108381|Behavioral|standard care|standard psychological treatment
16368465|NCT00108368|Drug|Risperidone|
16368466|NCT00108368|Drug|Olanzapine|
16368467|NCT00108355|Drug|Albumin|Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed
16368468|NCT00108355|Drug|Intravenous Saline Infusion (Albumin placebo)|Intravenous saline Infusion (Albumin placebo)
16368469|NCT00108355|Drug|Midodrine|Midodrine oral tablet at 10 mg three times a day.
16368470|NCT00108355|Drug|Oral tablet (Midodrine placebo)|Oral tablet (Midodrine placebo) three times a day
16368471|NCT00108355|Drug|Octreotide LAR|Octreotide LAR 20 mg intramuscular injection every 30 days
16368472|NCT00108355|Drug|Saline injection (Octreotide LAR placebo)|Saline intramuscular injection 5 cc every 30 days.
16368473|NCT00108355|Procedure|Large Volume Paracentesis|Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
16368474|NCT00108342|Drug|Nicotine gum - 2 mg and 4 mg|
16368475|NCT00108342|Drug|Nicotine lozenges - 2 mg and 4 mg|
16368476|NCT00108342|Drug|"Nicotine inhaler (4 mg yield) - low and high dosage by frequency of puffing"|can yield 4 mg from 10 mg device - infrequent and frequent puffing
16368477|NCT00108342|Other|Computer learning|
16368478|NCT00108329|Behavioral|Weight Loss|
16368479|NCT00108316|Drug|Fluoxetine (Liquid Prozac)|
16368480|NCT00108303|Other|Diagnostic|Diagnostic evaluation for schizophrenia. Schizophrenia includes schizophrenia and schizoaffective disorder.
16368481|NCT00108290|Drug|Chemotherapy|
16368482|NCT00108277|Behavioral|Breathing Training-Raise CO2|while breathing 9 breaths per minute, patients are instructed to raise CO2
16368483|NCT00108277|Behavioral|Breathing Training- Lower CO2|while breathing 9 breaths per minute, patients are instructed to lower CO2
16368484|NCT00108264|Biological|Tumor RNA transfected dendritic cells|
16368485|NCT00108251|Drug|Eplerenone|aldosterone receptor blocker
16368486|NCT00108251|Drug|Placebo|matching placebo
16368487|NCT00108238|Drug|Estradiol followed by progesterone|
16368488|NCT00108238|Drug|Raloxifene|
16368489|NCT00108225|Other|LoBag Diet - test phase|A Low Biologically Available Glucose (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.
16368490|NCT00108225|Other|LoBAG Diet - control phase|A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks
16368491|NCT00108212|Behavioral|Diet|
16368492|NCT00108199|Behavioral|Problem-Solving Training|
16368493|NCT00108199|Behavioral|Work-Related Social Skills Training|
16368494|NCT00108186|Drug|Celecoxib|Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.
16368495|NCT00108173|Drug|Zyban|
16368496|NCT00108160|Drug|Mupirocin Ointment [Treatment]|The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
16368497|NCT00108160|Drug|Polyethylene Glycol Ointment [Placebo]|The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
16368498|NCT00108147|Procedure|Circuit Training|
16368499|NCT00108147|Procedure|Cardiac Rehabilitation|
16368500|NCT00108147|Procedure|Flexibility and toning|
16368501|NCT00108134|Drug|PEP005|
16368502|NCT00108121|Drug|PEP005|
16368503|NCT00108108|Drug|HCD122|
16368504|NCT00108095|Drug|intravenous ondansetron|
16368505|NCT00108082|Drug|carvedilol MR|Study drug
16368506|NCT00108082|Drug|atenolol|Comparator
16368507|NCT00108082|Drug|lisinopril|Comparator
16368508|NCT00108069|Drug|Tamoxifen citrate|oral dose 120 mg twice a day, every day
16368509|NCT00108069|Drug|Bortezomib|intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
16368510|NCT00108056|Drug|Enzastaurin (LY317615) monohydronchloride|
16368511|NCT00108043|Procedure|FES-evoked functional upright gait|
16368512|NCT00108030|Procedure|Partial Body-weight supported Treadmill Training|
16368513|NCT00108030|Procedure|PBWST + Power training|
16368514|NCT00108030|Procedure|"Usual physiotherapy care"|
16368515|NCT00108017|Drug|MK0507A, dorzolamide hydrochloride (+) timolol maleate|
16368516|NCT00108017|Drug|Comparator: timolol maleate|
16368517|NCT00108017|Drug|Duration of Treatment: Part 1) 6 wk timolol maleate run in|
16368518|NCT00108017|Drug|Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds|
16368519|NCT00108004|Drug|pramlintide acetate|Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.
16368520|NCT00107991|Drug|etanercept|etanercept 50 mg/week subcutaneous injection
16368521|NCT00107978|Drug|Telavancin|Telavancin 10 mg/kg/day, IV for up to 14 days.
16368522|NCT00107978|Drug|Vancomycin|Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
16368523|NCT00107965|Drug|PEP005|0.0025% PEP005 Topical Gel (Day 1,2 application)
16368524|NCT00107965|Drug|PEP005|0.01% PEP005 Topical Gel (Day 1,2 application)
16368525|NCT00107965|Drug|PEP005|0.05% PEP005 Topical Gel (Day 1,2 application)
16368526|NCT00107965|Drug|PEP005|Vehicle Gel (Day 1,2 application)
16368527|NCT00107965|Drug|PEP005|0.0025% PEP005 Topical Gel (Day 1,8 application)
16368528|NCT00107965|Drug|PEP005|0.01% PEP005 Topical Gel (Day 1,8 application)
16368529|NCT00107965|Drug|PEP005|0.05% PEP005 Topical Gel (Day 1,8 application)
16368530|NCT00107965|Drug|PEP005|Vehicle Gel (Day 1,8 application)
16368531|NCT00107952|Drug|Telavancin|Telavancin 10 mg/kg/day IV for up to 21 days.
16368532|NCT00107952|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs for up to 21 days
16368533|NCT00107939|Drug|Licarbazepine|
16368534|NCT00107926|Drug|Licarbazepine|
16368535|NCT00107926|Drug|Placebo|
16368536|NCT00107913|Drug|Doxil|
16368537|NCT00107900|Drug|DU-176b|
16368538|NCT00107887|Drug|INH preventive therapy|Clinics will receive training regarding the use of IPT for prevention of Tuberculosis
16368539|NCT00107887|Drug|TST (tuberculin skin test)|Clinics will be trained in the use of TST for assessing exposure to TB
16368540|NCT00107874|Drug|misoprostol|
16368541|NCT00107861|Drug|Ad.hIFN-β (BG00001, IDEC-201)|
16368542|NCT00107848|Drug|Modafinil|
16368616|NCT00107354|Procedure|peripheral blood stem cell transplantation|
16368617|NCT00107341|Drug|bortezomib|
16368618|NCT00107341|Drug|carboplatin|
16368619|NCT00107341|Drug|paclitaxel|
16368543|NCT00107835|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures
16368544|NCT00107822|Drug|S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)|
16368545|NCT00107809|Drug|Modafinil|
16368546|NCT00107796|Drug|Modafinil|
16368547|NCT00107783|Drug|Nitisinone (NTBC)|Treatment
16368548|NCT00107770|Drug|sodium phenylbutyrate|histone deacteylase inhibitor
16368549|NCT00107757|Drug|GW685698X|
16368550|NCT00107744|Dietary Supplement|Soy protein-milk protein-carbohydrate|40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks
16368551|NCT00107744|Dietary Supplement|Milk protein-carbohydrate-soy protein|40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.
16368552|NCT00107744|Dietary Supplement|Carbohydrate-soy protein-milk protein|40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks.
16368553|NCT00107731|Drug|quetiapine fumarate|
16368554|NCT00107731|Drug|lithium|
16368555|NCT00107731|Drug|divalproex|
16368556|NCT00107718|Drug|SB-485232|
16368557|NCT00107705|Biological|Tree MATA MPL|
16368558|NCT00107692|Behavioral|Physical activity and diet|
16368559|NCT00107666|Drug|CTI-01 (ethyl pyruvate)|
16368560|NCT00107653|Drug|Ribavirin|1000-1200mg po daily for 48 weeks
16368561|NCT00107653|Drug|Peginterferon alfa-2a|180 micrograms sc/week for 48 weeks
16368562|NCT00107653|Drug|Ribavirin|1000-1200mg po daily for 48 weeks
16368563|NCT00107653|Drug|Peginterferon alfa-2a|180 micrograms sc/week for 48 weeks
16368564|NCT00107640|Behavioral|Patient-provider education|Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
16368565|NCT00107627|Other|Caprosyn subcuticular sutures.|Caprosyn subcuticular sutures.
16368566|NCT00107627|Other|Monocryl subcuticular sutures.|Monocryl subcuticular sutures.
16368567|NCT00107627|Other|Skin staples;|Skin staples;
16368568|NCT00107614|Drug|DT PACE + Rituxan|INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with < 50% response to induction) OR MEL-DT PACE (Patients with > 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year
16368569|NCT00107601|Drug|Insulin|
16368570|NCT00107588|Behavioral|Reinforcement for homework completion|Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills
16368571|NCT00107588|Behavioral|Reinforcement for Abstinence|Provides contingent reinforcement for submitting marijuana-free urine specimen
16368572|NCT00107588|Behavioral|Case Management|Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.
16368573|NCT00107575|Behavioral|Standard treatment plus brief alcohol intervention|Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
16368574|NCT00107575|Other|Standard treatment (ST)|Behavioral smoking cessation counseling and nicotine patch.
16368575|NCT00107562|Behavioral|Adolescent Safer Sex Social Network Intervention|
16368576|NCT00107549|Biological|rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])|Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
16368577|NCT00107549|Biological|rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])|Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
16368578|NCT00107536|Drug|lapatinib ditosylate|
16368579|NCT00107536|Other|laboratory biomarker analysis|Correlative studies
16368580|NCT00107523|Drug|cytarabine|
16368581|NCT00107523|Drug|idarubicin|
16368582|NCT00107523|Drug|pravastatin|
16368583|NCT00107510|Biological|pegfilgrastim|
16368584|NCT00107510|Drug|carboplatin|
16368585|NCT00107510|Drug|docetaxel|
16368586|NCT00107510|Procedure|conventional surgery|
16368587|NCT00107497|Radiation|Radiation therapy|
16368588|NCT00107484|Drug|ferumoxtran-10|
16368589|NCT00107484|Procedure|magnetic resonance imaging|
16368590|NCT00107484|Procedure|sentinel lymph node biopsy|
16368591|NCT00107471|Biological|filgrastim|Given PO
16368592|NCT00107471|Drug|topotecan hydrochloride|Given IV
16368593|NCT00107471|Radiation|radiation therapy|
16368594|NCT00107458|Drug|valproic acid|
16368595|NCT00107445|Drug|EF5|Given IV
16368596|NCT00107432|Drug|sorafenib tosylate|Given orally
16368597|NCT00107432|Other|laboratory biomarker analysis|Correlative studies
16368598|NCT00107419|Drug|pemetrexed disodium|pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
16368599|NCT00107393|Biological|trastuzumab|
16368600|NCT00107393|Drug|capecitabine|
16368601|NCT00107380|Biological|rituximab|
16368602|NCT00107380|Drug|cyclophosphamide|
16368603|NCT00107380|Drug|doxorubicin hydrochloride|
16368604|NCT00107380|Drug|prednisone|
16368605|NCT00107380|Drug|vincristine sulfate|
16368606|NCT00107380|Radiation|tositumomab and iodine I 131 tositumomab|
16368607|NCT00107367|Procedure|conventional surgery|
16368608|NCT00107367|Radiation|intraoperative radiation therapy|
16368609|NCT00107354|Biological|aldesleukin|
16368610|NCT00107354|Biological|therapeutic allogeneic lymphocytes|
16368611|NCT00107354|Biological|therapeutic autologous lymphocytes|
16368612|NCT00107354|Drug|cytarabine|
16368613|NCT00107354|Drug|etoposide|
16368614|NCT00107354|Drug|mitoxantrone hydrochloride|
16368615|NCT00107354|Procedure|allogeneic bone marrow transplantation|
16368622|NCT00107289|Radiation|iobenguane I 131|"Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation.
~After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year."
16368623|NCT00107276|Drug|capecitabine|
16368624|NCT00107276|Drug|cyclophosphamide|
16368625|NCT00107263|Drug|letrozole|
16368626|NCT00107263|Drug|zoledronic acid|
16368627|NCT00107250|Drug|capecitabine|1000 mg/m2 orally twice daily (total of 2000 mg/m2 per day) for the first 14 days of a 21 day cycle for a maximum of 6-8 cycles.
16368628|NCT00107250|Drug|carboplatin|AUC 6; IV; 30 minutes; Every 21 days for a maximum of 6-8 cycles
16368629|NCT00107250|Drug|cediranib maleate|Given daily; orally with approximately 240 ml of water whilst in an upright position
16368630|NCT00107250|Drug|paclitaxel|200mg/m2; IV; 3 hours; Every 21 days for a maximum of 6-8 cycles
16368631|NCT00107237|Drug|AEE788|AEE788 was available in the form of a hard gelatin capsule of 50 mg or 100 mg strengths and packaged in bottles.
16368632|NCT00107237|Drug|everolimus|Everolimus was formulated as tablets of 2.5 mg and 5 mg strength and supplied in blister packs.
16368633|NCT00107211|Biological|therapeutic autologous dendritic cells|
16368634|NCT00107211|Procedure|conventional surgery|
16368635|NCT00107211|Procedure|neoadjuvant therapy|
16368636|NCT00107198|Drug|doxorubicin hydrochloride|Given IV
16368637|NCT00107198|Procedure|conventional surgery|Undergo surgery
16368638|NCT00107198|Drug|cyclophosphamide|Given IV
16368639|NCT00107198|Drug|prednisone|Given IV or PO
16368640|NCT00107198|Drug|vincristine sulfate|Given IV
16368641|NCT00107198|Radiation|radiation therapy|Undergo IFRT
16368642|NCT00107185|Biological|therapeutic autologous dendritic cells|
16368643|NCT00107172|Procedure|surgery|
16368644|NCT00107172|Radiation|brachytherapy|
16368645|NCT00107159|Biological|autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine|
16368646|NCT00107120|Drug|Escitalopram|Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
16368647|NCT00107120|Drug|Placebo|Placebo once daily for up to 8 weeks
16368648|NCT00107107|Drug|pramlintide acetate|Syringe vial and Pen-cartridge
16368649|NCT00107094|Drug|Abraxane|
16368650|NCT00107081|Drug|ciprofloxacin and amoxicillin|
16368651|NCT00107081|Procedure|Outpatient management|
16368652|NCT00107081|Drug|i.v. antibiotics|
16368653|NCT00107081|Procedure|inpatient management|
16368654|NCT00107068|Procedure|[A] Aerobic isokinetic cycling exercise|
16368655|NCT00107068|Procedure|[B] Progressive Resistance Training|
16368656|NCT00107068|Procedure|[A] + [B]|
16368657|NCT00107055|Drug|REN-1654|
16368658|NCT00107042|Biological|Recombivax|Participants receive doses of Recombivax at weeks 0 and 24.
16368659|NCT00107042|Biological|Twinrix|Participants receive doses of Twinrix at weeks 0 and 24.
16368660|NCT00107016|Drug|RAD001, Letrozole 2.5mg|
16368661|NCT00107016|Drug|Letrozole 2.5mg|
16368662|NCT00107003|Drug|lapatinib ditosylate|
16368663|NCT00107003|Procedure|Adjuvant therapy|
16368664|NCT00107003|Procedure|Conventional surgery|
16368665|NCT00107003|Procedure|Neoadjuvant therapy|
16368666|NCT00106964|Biological|Engerix-B 20 mcg|A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
16368667|NCT00106964|Biological|Engerix-B 40 mcg|A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
16368668|NCT00106964|Biological|Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg|"Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml:
~A single dose of 1 mL will be administered in the deltoid muscle."
16368669|NCT00106938|Device|Carotid artery stenting with filter (interventional)|Carotid artery stenting with filter (interventional)
16368670|NCT00106938|Procedure|Carotid artery endarterectomy (surgical)|Carotid artery endarterectomy (surgical)
16368671|NCT00106899|Procedure|Magnetic Resonance Imaging (MRI)|MRI scans
16368672|NCT00106899|Procedure|Positron Emission Tomography (PET)|PET scans
16368673|NCT00106899|Procedure|Lumbar Puncture (LP)|collection of cerebrospinal fluid
16368674|NCT00106886|Drug|Folic acid, vitamin B6 and B12 or placebo|
16368675|NCT00106860|Drug|a benzodiazepine drug|
16368676|NCT00106847|Drug|Infliximab|
16368677|NCT00106834|Drug|Infliximab|
16368678|NCT00106821|Drug|Tiotropium Bromide Inhalation Powder|
16368679|NCT00106808|Drug|Muraglitazar|
16368680|NCT00106808|Drug|Pioglitazone|
16368681|NCT00106782|Procedure|Transcranial Electrical Polarization (TEP)|
16368682|NCT00106769|Drug|VRC-WNVDNA017-00-VP|
16368683|NCT00106717|Procedure|Narrative medicine|
16368684|NCT00106704|Drug|Comparator: Sitagliptin|sitagliptin 10 mg tablet, once daily for 54 weeks
16368685|NCT00106704|Drug|Comparator: Placebo|Placebo oral tablet once daily for 24 weeks
16368686|NCT00106704|Drug|Comparator: Pioglitazone|Pioglitazone 30 mg tablet once daily for 30 weeks
16368687|NCT00106691|Drug|Toremifene 20 mg|20 mg once a day
16368688|NCT00106691|Drug|Placebo|placebo tablet identically appearing to the toremifene 20 mg tablet, administered daily for 360 days.
16368689|NCT00106639|Drug|CP-690,550|15 mg twice daily
16368690|NCT00106639|Drug|CP-690,550|30 mg twice daily
16368691|NCT00106639|Drug|tacrolimus|dose adjusted according to level
16368692|NCT00106626|Drug|vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin|Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).
16369113|NCT00103272|Drug|bortezomib|Given IV
16368693|NCT00106613|Drug|FK228 (romidepsin)|Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
16368694|NCT00106600|Drug|Pixantrone IV infusion|
16368695|NCT00106587|Device|paclitaxel coated balloon catheter (device with drug)|
16368696|NCT00106574|Drug|Placebo|iv every 4 weeks
16368697|NCT00106574|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
16368698|NCT00106561|Drug|Spironolactone|
16368699|NCT00106561|Drug|Irbesartan|
16368700|NCT00106548|Drug|tocilizumab [RoActemra/Actemra]|4mg/kg iv / month
16368701|NCT00106548|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv / month
16368702|NCT00106548|Drug|Placebo|iv / month
16368703|NCT00106548|Drug|Methotrexate|10-25mg/week
16368704|NCT00106535|Drug|tocilizumab [RoActemra/Actemra]|4 mg/kg or 8 mg/kg IV/month every 4 weeks.
16368705|NCT00106535|Drug|Placebo|IV/month
16368706|NCT00106535|Drug|Methotrexate|10-25 mg/week
16368707|NCT00106522|Drug|Methotrexate|10-25mg weekly
16368708|NCT00106522|Drug|Placebo|iv every 4 weeks
16368709|NCT00106522|Drug|tocilizumab [RoActemra/Actemra]|8mg/kg iv every 4 weeks
16368710|NCT00106522|Drug|tocilizumab [RoActemra/Actemra]|4mg/kg iv every 4 weeks
16368711|NCT00106509|Drug|tolevamer potassium-sodium (GT267-004)|
16368712|NCT00106496|Drug|Protopic|topical
16368713|NCT00106496|Drug|Corticosteroid|topical
16368714|NCT00106496|Drug|placebo|topical
16368715|NCT00106431|Drug|romidepsin (depsipeptide, FK228)|Study patients received romidepsin at a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
16368716|NCT00106418|Drug|Romidepsin|13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
16368717|NCT00106405|Drug|Memantine HCl|
16368718|NCT00106392|Drug|Tacrolimus|oral
16368719|NCT00106392|Drug|Placebo|oral
16368720|NCT00106379|Drug|Truvada (tenofovir DF + emtricitabine)|
16368721|NCT00106379|Drug|Emtriva (emtricitabine)|
16368722|NCT00106379|Drug|Viread (tenofovir DF)|
16368723|NCT00106366|Drug|insulin detemir|
16368724|NCT00106366|Drug|insulin glargine|
16368725|NCT00106366|Drug|insulin aspart|
16368726|NCT00106353|Drug|Torisel|60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.
16368727|NCT00106340|Drug|vildagliptin|
16368728|NCT00106340|Drug|glimepiride|
16368729|NCT00106340|Drug|Metformin|
16368730|NCT00106340|Drug|Vildagliptin matching placebo|
16368731|NCT00106340|Drug|Glimepiride matching placebo|
16368732|NCT00106327|Behavioral|Exercise|6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program.
16368733|NCT00106327|Behavioral|Diet|11 nutrition education sessions
16368734|NCT00106314|Drug|Dehydroepiandrosterone [DHEA]|
16368735|NCT00106301|Drug|FK228 (romidepsin)|Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
16368736|NCT00106288|Drug|Micafungin|IV
16368737|NCT00106288|Drug|Liposomal Amphotericin B|IV
16368738|NCT00106275|Behavioral|Mindfulness Based Stress Reduction|
16368739|NCT00106262|Drug|Velcade (bortezomib)|
16368740|NCT00106262|Drug|Irinotecan|
16368741|NCT00106249|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.
16368742|NCT00106249|Device|Sham|Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
16368743|NCT00106236|Behavioral|exercise|
16368744|NCT00106223|Behavioral|Cognitive behavioral therapy (CBT)|Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques.
16368745|NCT00106210|Behavioral|Early intervention blending several tx approaches, w/ focus|Early intervention blending several different treatment approaches, with a focus on certain skills
16368746|NCT00106210|Behavioral|Early intervention blending several treatment approaches|Early intervention blending several different treatment approaches
16368747|NCT00106197|Drug|Bupropion|Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.
16368748|NCT00106184|Drug|Rituximab|Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Group B - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum does of 1 gram at Weeks 8 and 9
16368749|NCT00106184|Drug|Placebo|"Treatment Group A: placebo infusion at Weeks 8 and 9
~Treatment Group B: placebo infusion at Weeks 0 and 1"
16368750|NCT00106171|Drug|Highly active antiretroviral therapy (HAART)|Regimens will be assigned by investigators
16368751|NCT00106158|Biological|protein vaccination|
16368867|NCT00105079|Drug|Emtricitabine/tenofovir disoproxil fumarate|Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
16368752|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor|Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.
16368753|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 450 mg|Dose 450 mg capsules daily for 28 day cycles.
16368754|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off|Dose escalating in a repeating intermittent dosing schedule of 3 days on and 4 days off at rising dose levels of 450, 600, 800, 1000, 1200, and 1400 mg/day.
16368755|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off|Dose escalating in a repeating intermittent dosing schedule of 1 day on/6 days off at rising dose levels of 600, 900, 1200, 1500, 1800, 2400, 3200 mg/day once weekly and then increase at 33% increments.
16368756|NCT00106145|Drug|Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg|Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION
16368757|NCT00106132|Drug|Triamcinolone Acetonide|
16368758|NCT00106119|Drug|Liothyronine and Levothyroxine|Hypothyroid patients are treated with Liothyronine and Levothyroxine in 2 crossover, randomized phases
16368759|NCT00106106|Procedure|NMR-spectroscopy|Scans were performed on a 3T scanner using the echo-time-averaged PRESS sequence previously published to detect glutamate's resonance line at 2.35 ppm and average out the interferences from glutamine, NAA and the macromolecules.
16368760|NCT00106106|Drug|Oral acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
16368761|NCT00106080|Behavioral|Audit and Feedback|Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
16368762|NCT00106067|Behavioral|coping and communication support (CCS) intervention|"Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.
~The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families."
16368763|NCT00106054|Drug|Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.|
16368764|NCT00106041|Behavioral|Veterans Integrated Palliative Care Nurse Case Manager|Palliative Care nurse case management
16368765|NCT00106028|Drug|risedronate sodium (Actonel)|risedronate tablet once a day for one year followed by risedronate once a day for two years
16368766|NCT00106028|Drug|Placebo|placebo tablet once a day for one year followed by risedronate once a day for two years
16368767|NCT00106002|Drug|pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
16368768|NCT00105989|Drug|Duloxetine|
16368769|NCT00105989|Drug|placebo|
16368770|NCT00105976|Drug|MM-093|
16368771|NCT00105963|Behavioral|Education about infant crying|
16368772|NCT00105950|Drug|lapatinib|Tyrosine kinase inhibitor administered daily at 1500 mg/kg
16368773|NCT00105937|Drug|OraVescent fentanyl citrate|
16368774|NCT00105911|Behavioral|Cognitive Behavioral Therapy|
16368775|NCT00105898|Procedure|Web-based care management|Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
16368776|NCT00105898|Procedure|Telephone and face-to-face care management|Participants interact with a care manager via face-to-face and telephone contact
16368777|NCT00105898|Procedure|Internet access alone|Participants are given internet access and encouraged to seek diabetes information to help in their self management
16368778|NCT00105885|Procedure|telephone care|Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinical visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval.
16368779|NCT00105872|Behavioral|Cognitive-Behavioral Therapy|
16368780|NCT00105859|Behavioral|Education and Counseling|
16368781|NCT00105846|Procedure|Home care telemedicine|
16368782|NCT00105833|Behavioral|Collaborative Care - Depression Decision Support (DDS)|Multifaceted collaborative intervention for depression based in primary care
16368783|NCT00105820|Procedure|System level depression care quality improvement|
16368784|NCT00105807|Behavioral|participation in low intensity exercise|
16368785|NCT00105807|Behavioral|participation in art and music activities|
16368786|NCT00105794|Procedure|Psychiatric Advance Directives intervention|
16368787|NCT00105781|Behavioral|Exercise counseling|
16368788|NCT00105768|Behavioral|Advisor-Teller Money Management-Substance Abuse Counselling|
16368789|NCT00105755|Device|personal dermal thermometer (DT)|
16368790|NCT00105755|Device|Device|
16368791|NCT00105742|Procedure|Diagnosis|
16368792|NCT00105729|Behavioral|Intensive referral to 12-step self-help groups|
16368793|NCT00105716|Behavioral|Telephone behavioral education|
16368794|NCT00105716|Behavioral|Computer behavioral education|
16368795|NCT00105703|Behavioral|Case management using advanced nurse practitioners|
16368796|NCT00105690|Behavioral|Telemedicine intervention|
16368797|NCT00105664|Procedure|Collaborative care model|
16368798|NCT00105664|Procedure|Group interventions|
16368799|NCT00105664|Procedure|Facilitated consultation|
16368800|NCT00105651|Behavioral|Combined nursing invention|
16368801|NCT00105638|Behavioral|educational program, by telephone|
16368802|NCT00105612|Device|Memory and Organizational Aid|
16368803|NCT00105612|Behavioral|Standard Informed Consent Process|The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home
16368804|NCT00105599|Behavioral|End of life care coordination|
16368805|NCT00105599|Procedure|FairCare System|
16368806|NCT00105586|Drug|Escitalopram|Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
16368868|NCT00105079|Drug|Ritonavir|100 mg po bid
16368807|NCT00105573|Behavioral|Maternal interpersonal psychotherapy (IP)|Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
16368808|NCT00105573|Behavioral|Infant-parent psychotherapy|Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
16368809|NCT00105573|Behavioral|Informational meetings plus treatment as usual|Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
16368810|NCT00105560|Radiation|radiation therapy|Radiation therapy with proton beam to standard doses
16368811|NCT00105547|Drug|MPC-7869|oral 800 mg BID
16368812|NCT00105547|Drug|MPC-7869|Oral BID dosing
16368813|NCT00105534|Drug|AzaSite|"1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected
~eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days."
16368814|NCT00105534|Other|Vehicle|Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
16368815|NCT00105521|Drug|Sarizotan|Sarizotan will be administered twice daily.
16368816|NCT00105521|Drug|Placebo|Placebo matching to sarizotan will be administered twice daily.
16368817|NCT00105508|Drug|Sarizotan|Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
16368818|NCT00105508|Drug|Placebo|Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
16368819|NCT00105495|Drug|Ferriprox (deferiprone)|
16368820|NCT00105495|Drug|Desferal (deferoxamine)|
16368821|NCT00105482|Drug|Naltrexone|Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
16368822|NCT00105482|Drug|Transdermal nicotine replacement|Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
16368823|NCT00105482|Behavioral|Behavioral counseling|Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
16368824|NCT00105469|Drug|AzaSite|AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
16368825|NCT00105469|Drug|Tobramycin|Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.
16368826|NCT00105443|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
16368827|NCT00105443|Drug|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid).
16368828|NCT00105430|Procedure|Deep Brain Stimulation|
16368829|NCT00105417|Drug|IL-7|
16368830|NCT00105404|Drug|Triamcinolone Acetonide|
16368831|NCT00105378|Behavioral|Dutch EASYcare Study Geriatric Intermediate Care Programme|
16368832|NCT00105365|Device|Shoe insert|Subjects with knee OA underwent gait analysis and knee pain and function assessment at baseline while wearing walking shoes and after four weeks of wearing walking shoes with lateral-wedged insoles.
16368833|NCT00105365|Other|walking shoes|walking shoes
16368834|NCT00105352|Procedure|Mixed Meal Tolerance Test|
16368835|NCT00105352|Procedure|Glucagon Stimulation Test|
16368836|NCT00105326|Drug|paliperidone ER|
16368837|NCT00105313|Drug|MEDI-507|
16368838|NCT00105300|Drug|Adalimumab|
16368839|NCT00105287|Drug|OraVescent fentanyl (OVF)|
16368840|NCT00105248|Behavioral|patient-centered communication training|
16368841|NCT00105235|Drug|Alemtuzumab|T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
16368842|NCT00105235|Drug|Cyclosporine|Oral immunosuppressant
16368843|NCT00105235|Drug|Mycophenolate mofetil|Oral immunosuppressant
16368844|NCT00105235|Drug|Tacrolimus|Oral immunosuppressant
16368845|NCT00105235|Procedure|Liver transplant|Occurs at study entry
16368846|NCT00105235|Procedure|Immunosuppression withdrawal|Beginning no earlier than Year 1
16368847|NCT00105222|Drug|Sodium Nitrite|
16368848|NCT00105209|Drug|Aspirin|
16368849|NCT00105209|Drug|clopidogrel|
16368850|NCT00105196|Drug|Aripiprazole+ ADT|Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
16368851|NCT00105196|Drug|Placebo+ ADT|Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
16368852|NCT00105183|Biological|Placebo|placebo infusion, single
16368853|NCT00105183|Biological|EZ-2053|single IV infusion, 9 mg/kg
16368854|NCT00105183|Biological|EZ-2053 5mg/kg|single IV infusion, 5mg/kg
16368855|NCT00105170|Drug|hCBE-11|
16368856|NCT00105157|Drug|Comparator: MK0518|MK0518 oral tablets 200 mg b.i.d, for 24 weeks
16368857|NCT00105157|Drug|MK0518|MK0518 oral tablets 400 mg b.i.d, for 24 weeks
16368858|NCT00105157|Drug|MK0518|MK0518 oral tablets 600 mg b.i.d, for 24 weeks
16368859|NCT00105157|Drug|Placebo|Placebo to MK0518, oral tablet b.i.d, for 24 weeks
16368860|NCT00105144|Drug|Micafungin|IV
16368861|NCT00105144|Drug|Caspofungin|IV
16368862|NCT00105118|Device|Magstim Super Rapid Magnetic Stimulator|
16368863|NCT00105105|Drug|Mifepristone|
16368864|NCT00105092|Drug|Enzastaurin HCL|
16368865|NCT00105079|Drug|saquinavir [Invirase]|1000 milligram (mg) Oral (po) twice daily (bid)
16368866|NCT00105079|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 400/100 mg po bid
16368869|NCT00105066|Drug|Metformin|850mg tablet once a day for one month, then twice a day for 3 months
16368870|NCT00105066|Drug|Placebo|placebo tablet once a day for one month, then twice a day for 3 months
16368871|NCT00105053|Biological|HyperAcute-Prostate Cancer Vaccine|Before enrollment in the Phase I and Phase II- Arm A studies, the patient must be determined to have measurable disease with biopsies on first recurrence or bone metastases. In the Phase II- Arm B study, patients will be men with non-measurable progressive disease as evidenced by elevated PSA only. Cells will be injected intradermally every two weeks for 12 cycles on a prime-boost regimen. Dosage will vary from 30 million to 500 million HAP cells.
16368872|NCT00105040|Drug|Levetiracetam|Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
16368873|NCT00105040|Other|Placebo (PB)|Oral tablets and oral solution
16368874|NCT00105027|Other|Standard Care|CRVO: observation; BRVO: standard care
16368875|NCT00105027|Drug|intravitreal triamcinolone injection|1 mg dose
16368876|NCT00105027|Drug|intravitreal triamcinolone injection|4 mg
16368877|NCT00105001|Drug|Fludarabine Phosphate|Given IV
16368878|NCT00105001|Radiation|Total-Body Irradiation|Undergo total-body irradiation
16368879|NCT00105001|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16368880|NCT00105001|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16368881|NCT00105001|Drug|Tacrolimus|Given IV or PO
16368882|NCT00105001|Drug|Mycophenolate Mofetil|Given PO
16368883|NCT00105001|Drug|Sirolimus|Given PO
16368884|NCT00104988|Drug|temozolomide|75 mg/m^2/day PO daily for 6 weeks followed by a 2-week break
16368885|NCT00104988|Drug|thalidomide|200 mg/day PO daily
16368886|NCT00104975|Biological|alemtuzumab|
16368887|NCT00104975|Biological|therapeutic allogeneic lymphocytes|
16368888|NCT00104975|Drug|fludarabine phosphate|
16368889|NCT00104975|Drug|melphalan|
16368890|NCT00104975|Drug|tacrolimus|
16368891|NCT00104975|Drug|thiotepa|
16368892|NCT00104975|Procedure|peripheral blood stem cell transplantation|
16368893|NCT00104962|Drug|lenalidomide|Given orally
16368894|NCT00104949|Biological|trastuzumab|
16368895|NCT00104936|Procedure|adjuvant therapy|
16368896|NCT00104936|Radiation|radiation therapy|
16368897|NCT00104936|Radiation|stereotactic radiosurgery|
16368898|NCT00104923|Drug|fenretinide|Current dose level as an IV continuous infusion via central line over 5 days. Cycle is repeated every 3 weeks for up to 6 cycles
16368899|NCT00104910|Radiation|Internal Radiation Therapy|
16368900|NCT00104910|Radiation|3-Dimensional Conformal Radiation Therapy|
16368901|NCT00104910|Biological|Cetuximab|Given IV
16368902|NCT00104910|Drug|Cisplatin|Given IV
16368903|NCT00104897|Drug|tanespimycin|
16368904|NCT00104884|Drug|Depsipeptide|Given IV
16368905|NCT00104871|Drug|Bortezomib|Administered IV at the dose of 1.3 mg/m^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).
16368906|NCT00104858|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
16368907|NCT00104858|Drug|Cyclosporine|Given PO
16368908|NCT00104858|Drug|Fludarabine Phosphate|Given IV
16368909|NCT00104858|Other|Laboratory Biomarker Analysis|Correlative studies
16368910|NCT00104858|Drug|Mycophenolate Mofetil|Given PO
16368911|NCT00104858|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo HSCT
16368912|NCT00104858|Other|Pharmacological Study|Correlative studies
16368913|NCT00104858|Biological|Rituximab|Given IV
16368914|NCT00104858|Radiation|Total-Body Irradiation|Undergo TBI
16368915|NCT00104845|Biological|human gp100 plasmid DNA vaccine|
16368916|NCT00104845|Biological|mouse gp100 plasmid DNA vaccine|
16368917|NCT00104819|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16368918|NCT00104819|Biological|sargramostim|
16368919|NCT00104806|Dietary Supplement|cholecalciferol|100 milligrams orally once a day for 28 days
16368920|NCT00104806|Drug|arsenic trioxide|0.3 milligram/kilogram weight intravenously for 5 days (loading) then 0.25/kg weight intravenously biweekly
16368921|NCT00104793|Drug|carboplatin|
16368922|NCT00104793|Drug|irinotecan hydrochloride|
16368923|NCT00104780|Biological|EP-2101|
16368924|NCT00104780|Biological|incomplete Freund's adjuvant|
16368925|NCT00104767|Drug|celecoxib|
16368926|NCT00104754|Drug|liposomal SN-38|
16368927|NCT00104741|Drug|flutamide|
16368928|NCT00104741|Drug|triptorelin|
16368929|NCT00104741|Radiation|radiation therapy|
16368930|NCT00104728|Drug|ZD1839|
16368931|NCT00104715|Drug|antiandrogen therapy|
16368932|NCT00104715|Drug|docetaxel|
16368933|NCT00104715|Drug|goserelin acetate|
16368934|NCT00104715|Procedure|orchiectomy|
16368935|NCT00104702|Procedure|adjuvant therapy|
16368936|NCT00104702|Procedure|conventional surgery|
16368937|NCT00104702|Radiation|radiation therapy|
16368938|NCT00104689|Drug|capecitabine|
16368939|NCT00104689|Drug|oxaliplatin|
16368940|NCT00104676|Biological|bleomycin sulfate|At least one course administered
16368941|NCT00104676|Drug|cisplatin|At least one course administered
16368942|NCT00104676|Drug|etoposide|At least one course administered
16368943|NCT00104676|Drug|ifosfamide|Given in a dose-dense sequential fashion
16368944|NCT00104676|Drug|oxaliplatin|Given in a dose-dense sequential fashion
16368945|NCT00104676|Drug|paclitaxel|Given in a dose-dense sequential fashion
16368946|NCT00104663|Drug|Quinacrine|
16368947|NCT00104650|Genetic|AMG 162 180 mg (SC) q 12 weeks|A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.
16369189|NCT00102739|Drug|SB497115|
16368948|NCT00104650|Drug|IV Bisphosphonate q 4 weeks|IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.
16368949|NCT00104650|Genetic|AMG 162- 180 mg q 4 weeks|A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.
16368950|NCT00104637|Drug|sildenafil citrate|sildenafil citrate 25 mg by mouth thrice daily (po tid)
16368951|NCT00104637|Drug|Placebo|25 mg po tid
16368952|NCT00104624|Drug|docetaxel|
16368953|NCT00104624|Procedure|quality-of-life assessment|
16368954|NCT00104611|Device|Repetitive Transcranial Magnetic Stimulation|
16368955|NCT00104598|Drug|Bupropion|
16368956|NCT00104598|Behavioral|Smoking Abstinence Program|This investigation was a randomized controlled study of two framed message conditions for smoking cessation in combination with open label bupropion SR (300 mg/day). Two hundred fifty-eight cigarette smokers were randomly assigned to receive either gain- or loss-framed video and printed messages encouraging smoking abstinence. Preproduced video and printed information were chosen as the intervention media because of their reliability in delivering specific framed messages. All participants were seen at a community mental health center for 6 months and received a 7-week supply of bupropion SR.
16368957|NCT00104572|Drug|Androgel (Testosterone Gel)|1 mg tablet for 12 months
16368958|NCT00104572|Drug|Anastrozole (Aromatase Inhibitor)|
16368959|NCT00104572|Drug|Placebo tablet|Daily for 12 months
16368960|NCT00104572|Drug|Placebo gel|Daily for 12 months
16368961|NCT00104572|Dietary Supplement|Calcium Cardone 500mg with vitamin D 400 IU|1 tablet three times a day
16368962|NCT00104559|Behavioral|iMIC-generated consent form and tutorial|Computer-based consent form and tutorial
16368963|NCT00104559|Behavioral|Standard paper consent form|Standard paper consent form
16368964|NCT00104546|Procedure|Acupuncture point injection of vitamin K|
16368965|NCT00104533|Device|Magnets|
16368966|NCT00104520|Drug|AZLI 75 mg two times a day (BID)/three times a day (TID)|
16368967|NCT00104520|Drug|Placebo two times a day (BID)/three times a day (TID)|
16368968|NCT00104507|Drug|APD356|
16368969|NCT00104494|Drug|Zinc acetate (20mg/d)|Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo
16368970|NCT00104481|Behavioral|cognitive behavior therapy|
16368971|NCT00104468|Drug|Troxatyl™ (Cytotoxic Chemotherapeutic)|
16368972|NCT00104455|Drug|activated recombinant human factor VII|
16368973|NCT00104442|Drug|Rivastigmine|
16368974|NCT00104429|Drug|GW873140|
16368975|NCT00104429|Drug|Combivir|
16368976|NCT00104416|Drug|lamotrigine (LAMICTAL) extended-release|Primary experimental dosage form
16368977|NCT00104416|Drug|Placebo|Placebo control
16368978|NCT00104403|Drug|GW679769|
16368979|NCT00104403|Drug|Dexamethasone|
16368980|NCT00104403|Drug|Ondansetron Hydrochloride|
16368981|NCT00104390|Biological|Grass MATA MPL|
16368982|NCT00104377|Biological|Grass MATA MPL|
16368983|NCT00104364|Drug|MK0731|
16368984|NCT00104338|Drug|FK778|
16368985|NCT00104299|Drug|Rituximab plus cyclophosphamide placebo (rituximab group)|375 mg/m^2 infusions once weekly for 4 week
16368986|NCT00104299|Drug|Cyclophosphamide plus rituximab placebo (control group)|2 mg/kg/day orally for months 1-3
16368987|NCT00104299|Drug|Azathioprine|2 mg/kg/day orally for months 4-6
16368988|NCT00104299|Drug|Methylprednisolone (or other glucocorticoid)|1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab
16368989|NCT00104299|Drug|Prednisone|During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.
16368990|NCT00104286|Drug|Troxatyl™ (Cytotoxic Chemotherapeutic)|
16368991|NCT00104273|Drug|Rasagiline|
16368992|NCT00104260|Drug|sapropterin dihydrochloride|
16368993|NCT00104247|Drug|sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin|
16368994|NCT00104234|Drug|N-acetylgalactosamine 4-sulfatase|
16368995|NCT00104234|Drug|Placebo/rhASB|
16368996|NCT00104182|Drug|insulin detemir|
16368997|NCT00104182|Drug|insulin NPH|
16368998|NCT00104169|Drug|Epoetin Alfa|
16368999|NCT00104156|Procedure|External Qigong therapy|
16369000|NCT00104143|Drug|A4I Antagonist|
16369001|NCT00104130|Drug|KOS-862|
16369002|NCT00104117|Drug|XL999|XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.
16369003|NCT00104104|Drug|zoledronic acid|4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
16369004|NCT00104091|Drug|TP-38|TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.
16369005|NCT00104078|Drug|MYO-029|
16369006|NCT00104065|Drug|CG53135-05, velafermin|
16369007|NCT00104052|Biological|peginterferon alfa-2b (PEG2b) (SCH 54031)|PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.
16369008|NCT00104052|Drug|ribavirin (SCH 18908)|15 mg/kg/day for up to 48 weeks
16369009|NCT00104013|Drug|xaliproden (SR57746A)|
16369010|NCT00103974|Biological|BHT-3009-01|
16369011|NCT00103961|Behavioral|Questionnaire|A behavioral questionnaire will occur at Week 8
16369012|NCT00103948|Drug|Aricept|
16369013|NCT00103935|Drug|placebo|Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
16369107|NCT00103285|Drug|Mercaptopurine|Given PO
16369014|NCT00103935|Drug|placebo|Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
16369015|NCT00103935|Drug|Exenatide LAR|Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
16369016|NCT00103935|Drug|Exenatide LAR|Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
16369017|NCT00103922|Drug|cilomilast|
16369018|NCT00103870|Procedure|Electrodermal stimulation|
16369019|NCT00103870|Procedure|Music listening task|
16369020|NCT00103857|Drug|Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)|MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
16369021|NCT00103857|Drug|Comparator: MK0431 100 mg q.d. (q.d. = once daily)|MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
16369022|NCT00103857|Drug|Comparator: Placebo (Phase A)/Metformin (Phase B)|During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
16369023|NCT00103857|Drug|Comparator: Metformin 500 mg b.i.d.|Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
16369024|NCT00103857|Drug|Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.|MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
16369025|NCT00103857|Drug|Comparator: Metformin 1000 mg b.i.d.|Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
16369026|NCT00103844|Drug|Dasatinib|Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
16369027|NCT00103844|Drug|Imatinib|Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks
16369028|NCT00103831|Drug|Oral Taxane|
16369029|NCT00103818|Drug|gaboxadol|Duration of Treatment: 3 months
16369030|NCT00103818|Drug|Comparator: placebo (unspecified)|Duration of Treatment: 3 months
16369031|NCT00103805|Drug|levodopa|
16369032|NCT00103792|Drug|mycophenolate mofetil|2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
16369033|NCT00103792|Drug|cyclophosphamide|2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
16369034|NCT00103779|Drug|SGN-40 (anti-huCD40 mAb)|1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.
16369035|NCT00103766|Drug|Alteplase|
16369036|NCT00103753|Drug|deferiprone|
16369037|NCT00103740|Drug|zoledronic acid|5 mg zoledronic acid in 5 mL of sterile water for infusion
16369038|NCT00103740|Drug|placebo to zoledronic acid|5 mL of sterile water for infusion
16369039|NCT00103740|Drug|Risedronate|30mg oral tablets overencapsulated to match the placebo capsules
16369040|NCT00103740|Drug|Placebo to risedronate|oral capsules
16369041|NCT00103740|Drug|Calcium and vitamin D supplements|Calcium and vitamin D supplements were supplied
16369042|NCT00103727|Drug|Talnetant|talnetant
16369043|NCT00103727|Other|placebo|Placebo Comparator
16369044|NCT00103727|Other|risperidone|Active Comparator
16369045|NCT00103714|Drug|denufosol tetrasodium (INS37217)|
16369046|NCT00103701|Drug|Dasatinib|Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
16369047|NCT00103675|Procedure|Acupuncture|
16369048|NCT00103662|Drug|Granulocyte colony-stimulating factor plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
16369108|NCT00103285|Drug|Methotrexate|Given IM or IT
16369109|NCT00103285|Drug|Pegaspargase|Given IM
16369110|NCT00103285|Drug|Thioguanine|Given PO
16369111|NCT00103285|Drug|Vincristine Sulfate|Given IV
16369112|NCT00103272|Drug|tanespimycin|Given IV
16369049|NCT00103662|Drug|Granulocyte colony-stimulating factor plus placebo|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
16369050|NCT00103649|Drug|xaliproden (SR57746A)|
16369051|NCT00103636|Procedure|Extending peripheral intravenous (IV) cannula dwell times|
16369052|NCT00103623|Drug|Plenaxis|
16369053|NCT00103610|Drug|Granulocyte colony-stimulating factor plus plerixafor|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
16369054|NCT00103610|Drug|Granulocyte colony-stimulating factor plus placebo|Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
16369055|NCT00103597|Drug|Fludrocortisone|
16369056|NCT00103597|Drug|Domperidone|
16369057|NCT00103597|Behavioral|Conservative Measures for Orthostatic Hypotension|
16369058|NCT00103584|Biological|LC16m8 Smallpox Vaccine|
16369059|NCT00103571|Drug|Olanzapine|
16369060|NCT00103571|Drug|Aripiprazole|
16369061|NCT00103558|Drug|Lumiliximab with FCR|Dose, schedule, and duration specified in protocol
16369062|NCT00103545|Biological|ACA 125|
16369063|NCT00103532|Behavioral|Healthy Choices - Motivational Enhancement Intervention|Participants who are randomized to the intervention group will participate in four sessions (over approximately 3 months) of Healthy Choices; a motivational enhancement intervention specifically designed to target multiple risk behaviors in HIV+ youth. Participants will receive individualized referrals at the fourth session.
16369064|NCT00103532|Behavioral|Standard care|Participants will receive standard care plus referrals at three months post-baseline
16369065|NCT00103519|Drug|DITPA (3,5-diiodothyropropionic acid)|
16369066|NCT00103519|Drug|Placebo|Placebo
16369067|NCT00103506|Drug|Bortezomib (VELCADE)|1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
16369068|NCT00103506|Drug|Bortezomib (VELCADE)|1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles..
16369069|NCT00103506|Drug|Doxorubicin hydrochloride (DOXIL/CAELYX)|mg/m^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
16369070|NCT00103493|Behavioral|Motivational interviewing|
16369071|NCT00103493|Behavioral|Targeted DVD-based educational program|
16369072|NCT00103467|Biological|rPA102 Vaccine|
16369073|NCT00103454|Drug|GW685698X|
16369074|NCT00103428|Biological|CG7870|
16369075|NCT00103415|Behavioral|Endurance training|
16369076|NCT00103415|Behavioral|Weight-lifting training|
16369077|NCT00103402|Drug|Alfuzosin|
16369078|NCT00103402|Drug|Placebo|
16369079|NCT00103389|Drug|PI-88|PI-88+docetaxel
16369080|NCT00103389|Drug|docetaxel|docetaxel only
16369081|NCT00103376|Drug|Velcade|"Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.
~Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break"
16369082|NCT00103376|Drug|LH-RH Agonist|given as a 3 month depo-injection
16369083|NCT00103376|Drug|Androgen Receptor Antagonists|given orally daily for 3 months
16369084|NCT00103363|Other|cytology specimen collection procedure|
16369085|NCT00103363|Other|physiologic testing|
16369086|NCT00103363|Procedure|annual screening|
16369087|NCT00103363|Procedure|study of high risk factors|
16369088|NCT00103350|Drug|TG100-115|
16369089|NCT00103337|Drug|cilengitide|Given IV
16369090|NCT00103337|Other|laboratory biomarker analysis|Correlative studies
16369091|NCT00103324|Drug|lapatinib ditosylate|Given orally
16369092|NCT00103324|Other|laboratory biomarker analysis|Correlative studies
16369093|NCT00103311|Drug|ispinesib|Given IV
16369094|NCT00103311|Other|laboratory biomarker analysis|Correlative studies
16369095|NCT00103298|Drug|FOLFOX regimen|
16369096|NCT00103298|Drug|fluorouracil|
16369097|NCT00103298|Drug|isolated perfusion|
16369098|NCT00103298|Drug|leucovorin calcium|
16369099|NCT00103298|Drug|melphalan|
16369100|NCT00103298|Drug|oxaliplatin|
16369101|NCT00103285|Radiation|3-Dimensional Conformal Radiation Therapy|Some patients undergo cranial radiotherapy
16369102|NCT00103285|Drug|Cyclophosphamide|Given IV
16369103|NCT00103285|Drug|Cytarabine|Given IV or SC
16369104|NCT00103285|Drug|Dexamethasone|Given IV or PO
16369105|NCT00103285|Drug|Doxorubicin Hydrochloride|Given IV or IT
16369106|NCT00103285|Drug|Leucovorin Calcium|Given PO
16369114|NCT00103259|Drug|bortezomib|Given IV
16369115|NCT00103259|Drug|irinotecan hydrochloride|Given IV
16369116|NCT00103259|Other|laboratory biomarker analysis|Optional correlative studies
16369117|NCT00103246|Drug|silicon phthalocyanine 4|Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
16369118|NCT00103233|Biological|trastuzumab|
16369119|NCT00103233|Drug|vinorelbine tartrate|
16369120|NCT00103220|Drug|SJG-136|Given IV
16369121|NCT00103207|Biological|cetuximab|
16369122|NCT00103194|Drug|lapatinib ditosylate|Given PO
16369123|NCT00103194|Other|laboratory biomarker analysis|Correlative studies
16369124|NCT00103181|Radiation|3-dimensional conformal accelerated partial breast irradiation|
16369125|NCT00103181|Radiation|brachytherapy|
16369126|NCT00103181|Radiation|whole breast irradiation|Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
16369127|NCT00103181|Radiation|MammoSite or other single-entry intracavitary device|
16369128|NCT00103168|Drug|imatinib mesylate|400 mg/day for 2 years
16369129|NCT00103155|Procedure|conventional surgery|
16369130|NCT00103155|Procedure|radiofrequency ablation|
16369131|NCT00103142|Biological|falimarev|Given subcutaneously and intradermally
16369132|NCT00103142|Biological|inalimarev|Given subcutaneously and intradermally
16369133|NCT00103142|Biological|sargramostim|Given subcutaneously
16369134|NCT00103142|Biological|therapeutic autologous dendritic cells|Given subcutaneously and intradermally
16369135|NCT00103116|Biological|autologous dendritic cell cancer vaccine|"Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.
~Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part."
16369136|NCT00103103|Drug|bortezomib|
16369137|NCT00103103|Drug|fluorouracil|
16369138|NCT00103103|Drug|leucovorin calcium|
16369139|NCT00103051|Drug|cisplatin|
16369140|NCT00103051|Drug|gefitinib|
16369141|NCT00103051|Drug|gemcitabine hydrochloride|
16369142|NCT00103051|Procedure|conventional surgery|
16369143|NCT00103051|Procedure|neoadjuvant therapy|
16369144|NCT00103038|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo 3T MRI
16369145|NCT00103038|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo 3T DCE-MRI
16369146|NCT00103038|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo 3T DSC-MRI
16369147|NCT00103038|Drug|Ferumoxytol|Given IV
16369148|NCT00103038|Drug|Gadolinium|Given IV
16369149|NCT00103038|Procedure|MRI-Based Angiogram|Undergo MRA
16369150|NCT00103025|Drug|Sodium Nitrite|
16369151|NCT00103025|Drug|Sodium Nitrite Injection|
16369152|NCT00103012|Drug|Gingko Biloba|Ginkgo Biloba 120 mg twice daily for 14 days
16369153|NCT00103012|Drug|Echinacea purpurea|Echinacea purpurea 500 mg three times daily for 14 days
16369154|NCT00103012|Drug|Panax ginseng|Panax ginseng 500 mg twice daily
16369155|NCT00102986|Drug|Lopinavir/ritonavir|
16369156|NCT00102973|Drug|TLK286 in Combination with Carboplatin|Experimental Arm
16369157|NCT00102973|Drug|Doxorubicin HCl Liposome Injection|Active Comparator
16369158|NCT00102960|Drug|Abacavir sulfate|Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.
16369159|NCT00102960|Drug|Didanosine|Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age. Guidelines for switching from first line to second line therapy are available in the protocol.
16369160|NCT00102960|Drug|Efavirenz|Second Line Regimen: taken orally once daily. Dosage depends on weight. Guidelines for switching from first line to second line therapy are available in the protocol.
16369161|NCT00102960|Drug|Lamivudine|First Line Regimen: 4 mg/kg taken orally twice daily
16369162|NCT00102960|Drug|Lopinavir/Ritonavir|First Line Regimen: taken orally twice daily. Dosage depends on age and weight.
16369163|NCT00102960|Drug|Nevirapine|Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.
16369164|NCT00102960|Drug|Zidovudine|First Line Regimen: 240 mg/m^2 taken orally twice daily
16369165|NCT00102947|Drug|daptomycin (up to 14 days)|
16369166|NCT00102934|Drug|Enfuvirtide-intensified HAART|90 mg tablet taken orally twice daily
16369167|NCT00102921|Drug|CCX282-B|
16369168|NCT00102908|Drug|Zoledronate|Zoledronate infusion
16369169|NCT00102908|Drug|Zoledronate placebo|Zoledronate placebo infusion
16369170|NCT00102895|Drug|CP-724,714|
16369171|NCT00102882|Drug|fluticasone propionate/salmeterol|
16369172|NCT00102882|Drug|salmeterol xinafoate|
16369173|NCT00102869|Drug|levodopa|100mg levodopa per day over 10 days/ treatment phase
16369174|NCT00102856|Drug|Pramipexole|
16369175|NCT00102856|Drug|Rivastigmine|
16369176|NCT00102843|Procedure|supplementation with folic acid and betaine|
16369177|NCT00102830|Drug|AMG 386|
16369178|NCT00102817|Drug|somatropin|
16369179|NCT00102804|Drug|Pemetrexed|500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression
16369180|NCT00102804|Drug|Placebo|IV administration, q 21 days
16369181|NCT00102804|Other|Best Supportive Care|Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
16369182|NCT00102791|Drug|ICA-17043|
16369183|NCT00102778|Drug|GW873140|
16369184|NCT00102778|Drug|Kaletra (lopinavir/ritonavir)|
16369185|NCT00102765|Drug|fluticasone propionate/salmeterol powder|
16369186|NCT00102765|Drug|fluticasone propionate powder|
16369187|NCT00102752|Drug|Glufosfamide|
16369188|NCT00102752|Drug|Gemcitabine|
16369190|NCT00102726|Drug|SB497115|SB497115/Placebo will be administered for at least 2 cycles. Additional cycles are permited if: 1) chemotherapy is continued, 2) the subject appears to be benefitting from the study drug, and 3) the subject has not encountered greater than moderate toxicity with the study drug. The maximum number of cycles would be 8.
16369191|NCT00102726|Other|Placebo|Placebo administered orally daily on days 2 through 11 of each 21-day cycle.
16369192|NCT00102713|Drug|Divalproex Sodium (Depakote Sprinkle Capsules)|
16369193|NCT00102700|Drug|ARQ 501 in combination with gemcitabine|
16369194|NCT00102687|Drug|azacitidine|"Azacitidine is administered subcutaneously
~Total of 18 cycles on treatment or early discontinuation."
16369195|NCT00102674|Drug|cangrelor|
16369196|NCT00102661|Drug|Campath-1H|15 mg daily infused over 24 hours, continuous infusion x 7 days (Days 1 through 7). Each 15 mg dose prepared daily, immediately prior to starting the infusion. Starting day 10, CAMPATH-1H administered at dose of 30 mg subcutaneously three times weekly for 11 additional weeks.
16369197|NCT00102648|Drug|Lonafarnib|Given PO
16369198|NCT00102648|Drug|Temozolomide|Given PO
16369199|NCT00102635|Drug|Fenretinide (4-HPR)|Oral 100 mg capsules in two divided doses at least 8 hours apart for 7 days each cycle.
16369200|NCT00102635|Drug|SCH66336|Oral capsules with 50 mg, 75 mg, or 100 mg formulation in two divided doses at least 8 hours apart for 21 days each cycle.
16369201|NCT00102622|Biological|Intraperitoneal tgDCC-E1A|Starting Dose Level: 1.8 mg DNA/m^2 intraperitoneal every 7 days +/- 2 days for a total of 6 treatments each cycle.
16369202|NCT00102622|Drug|Paclitaxel|80 mg/m^2 intravenous (IV) every 7 days +/- 2 days for a total of 6 treatments.
16369203|NCT00102609|Drug|Doxorubicin|Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1
16369204|NCT00102609|Drug|Trabectedin|Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles
16369205|NCT00102609|Drug|Dexamethasone|Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin
16369206|NCT00102596|Drug|1-Octanol|1-Octanol is an long-chain alcohol with potential therapeutic benefits in treating alcohol-responsive tremors based on unknown mechanisms. The intervention consisted of either 1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
16369207|NCT00102583|Drug|Subconjunctival Cyclosporine Implant|
16369208|NCT00102557|Drug|Hydroxychloroquine|
16369210|NCT00102531|Drug|Cisplatin liposomal|
16369211|NCT00102518|Drug|Aripiprazole|2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses
16369212|NCT00102505|Drug|Motexafin Gadolinium Injection|
16369213|NCT00102492|Drug|GW679769|
16369214|NCT00102479|Drug|Aripiprazole|
16369215|NCT00102466|Drug|vildagliptin|
16369216|NCT00102466|Drug|Gliclazide|
16369217|NCT00102466|Drug|Metformin|
16369218|NCT00102453|Drug|Pentoxifylline|Pentoxifylline dosing: 20mg/Kg/day in a 20 mg/mL solution. Maximum dose of 1200mg/day. Dosing split into two equal parts taken morning and night with food.
16369219|NCT00102440|Drug|Febuxostat|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
16369220|NCT00102440|Drug|Febuxostat|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
16369221|NCT00102440|Drug|Allopurinol|Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.
16369222|NCT00102427|Behavioral|Telephone-based collaborative care management|
16369223|NCT00102414|Drug|Gemcitabine|
16369224|NCT00102401|Behavioral|Internet-based Dyspnea Self-Management Program|
16369225|NCT00102401|Behavioral|Face-to-face Dyspnea Self-Management Program|
16369226|NCT00102388|Drug|vildagliptin|
16369227|NCT00102388|Drug|Gliclazide|
16369228|NCT00102375|Drug|Topotecan|
16369229|NCT00102362|Behavioral|Behavior Therapy|
16369230|NCT00102349|Behavioral|Behavior Therapy|
16369231|NCT00102336|Biological|AMG 531|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
16369232|NCT00102336|Drug|Placebo|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
16369233|NCT00102323|Drug|Placebo|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.
16369234|NCT00102323|Biological|AMG 531|Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
16369235|NCT00102310|Drug|YM443|
16369236|NCT00102297|Drug|FG-3019|
16369237|NCT00102284|Drug|levodopa|
16369238|NCT00102284|Drug|rivastigmine|
16369239|NCT00102284|Drug|pergolid|
16369240|NCT00102284|Drug|modafinil|
16369241|NCT00102271|Drug|Oxypurinol|
16369242|NCT00102271|Drug|Sodium Nitrite|
16369243|NCT00102258|Drug|Growth Hormone Therapy|
16369244|NCT00102232|Procedure|supplementation with phosphatidylcholine|
16369245|NCT00102219|Drug|Pemetrexed|
16369246|NCT00102219|Drug|Doxorubicin|
16369247|NCT00102206|Drug|Abacavir sulfate|
16369248|NCT00102206|Drug|Emtricitabine|
16369249|NCT00102206|Drug|Lamivudine|
16369250|NCT00102206|Drug|Lopinavir/ritonavir|
16369251|NCT00102206|Drug|Saquinavir|
16369252|NCT00102206|Drug|Tenofovir disoproxil fumarate|
16369253|NCT00102206|Drug|Zidovudine|
16369254|NCT00102193|Device|Adacolumn Apheresis System|
16369255|NCT00102167|Drug|gaboxadol|Duration of Treatment -1 day
16369256|NCT00102154|Drug|MK0928, gaboxadol / Duration of Treatment: 10 months|
16369257|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
16369258|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
16369259|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
16369260|NCT00102141|Drug|Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)|1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
16369261|NCT00102141|Drug|Placebo|Placebo, given as tablets orally once daily in the morning for 8 weeks
16369262|NCT00102128|Drug|Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)|
16369263|NCT00102115|Drug|Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)|
16369264|NCT00102102|Drug|[18F]SPA-RQ|
16369265|NCT00102089|Biological|VRC-HIVADV014-00-VP booster|
16369266|NCT00102089|Drug|VRC-HIVADV014-00-VP|
16369267|NCT00102063|Drug|Aripiprazole tablet, 10 mg|Aripiprazole tablet 10 mg po qd x 42 days
16369268|NCT00102063|Drug|Aripiprazole tablet, 30 mg|Aripiprazole tablet 30 mg po qd x 42 days
16369269|NCT00102063|Drug|Placebo tablet|Placebo tablet po qd x 42 days
16369270|NCT00102050|Drug|NM-702 (phosphodiesterase inhibitor)|
16369271|NCT00102037|Drug|eptacog alfa (activated)|
16369272|NCT00102024|Drug|Unconjugated IDEC-159|
16369273|NCT00102024|Drug|111In-IDEC-159|
16369274|NCT00102024|Drug|90Y-IDEC-159|
16369275|NCT00102011|Procedure|annual screening|Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
16369276|NCT00102011|Procedure|fecal occult blood test|Participants undergo a baseline fecal occult blood test (FOBT)
16369277|NCT00102011|Procedure|screening colonoscopy|Patients undergo baseline screening colonoscopy
16369278|NCT00102011|Procedure|standard follow-up care|Standard care
16369279|NCT00101998|Drug|alvimopan|
16369280|NCT00101998|Drug|placebo|
16369281|NCT00101985|Drug|talnetant|
16369282|NCT00101972|Biological|monoclonal antibody RAV12|Escalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks
16369283|NCT00101959|Drug|Rebif|
16369284|NCT00101946|Drug|683699|
16369285|NCT00101933|Device|Medtronic DBS Therapy for epilepsy|Stimulation On
16369286|NCT00101933|Device|Medtronic DBS Therapy for epilepsy|Stimulation Off
16369287|NCT00101920|Drug|ABX-EGF|2.5 mg/kg by an infusion pump over one hour
16369288|NCT00101907|Drug|AMG 706|AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.
16369289|NCT00101907|Biological|Panitumumab|Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.
16369290|NCT00101907|Drug|Gemcitabine|Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m^2.
16369291|NCT00101907|Drug|Cisplatin|Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
16369292|NCT00101894|Drug|FOLFOX-4|"The FOLFOX-4 regimen will be administered every 2 weeks as follows:
~Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed"
16369293|NCT00101894|Drug|AMG 706|AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
16369294|NCT00101894|Biological|Panitumumab (Part 1a only)|Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
16369295|NCT00101894|Drug|FOLFIRI|Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
16369296|NCT00101881|Device|Defibrillation (biphasic versus monophasic shock)|Administration of monophasic or biphasic waveform defibrillation
16369297|NCT00101868|Device|Discharge communication software|Computerized physician order entry software used by discharging physician
16369298|NCT00101868|Other|Usual care discharge process|Handwritten
16369299|NCT00101855|Procedure|An evidence based tailored web site|
16369300|NCT00101842|Drug|Pemetrexed|
16369301|NCT00101842|Drug|Gemcitabine|
16369302|NCT00101842|Drug|Platinol|
16369303|NCT00101829|Drug|Rituximab|1000 mg intravenous infusion
16369304|NCT00101816|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.
16369305|NCT00101803|Drug|vildagliptin|
16369306|NCT00101790|Drug|pamidronate|There will be four study groups, each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The groups will occur in succession, not parallel. The dosage for group 1 will be 30 mg , 60 mg for group 2, and 90 mg for group 3. Group 4 will receive 2 treatments of 90mg IV pamidronate or placebo.
16369307|NCT00101764|Drug|Triamcinolone Acetonide|
16369308|NCT00101751|Drug|biphasic insulin aspart|
16369309|NCT00101751|Behavioral|dietary regimen|
16369310|NCT00101738|Drug|Myfortic|
16369311|NCT00101725|Drug|crofelemer|
16369312|NCT00101712|Drug|vildagliptin|
16369313|NCT00101712|Drug|Vildagliptin Placebo|
16369361|NCT00101283|Drug|pemetrexed disodium|500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle
16373631|NCT00083538|Drug|Cyclophosphamide|
16369314|NCT00101686|Drug|Modified Bolus 5-FU/LV with Irinotecan|Day 1 & 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
16369315|NCT00101686|Drug|FOLFIRI + bevacizumab|"Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
~I m m e d i a t e l y f o l l o w e d b y :
~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
~Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
~I m m e d i a t e l y f o l l o w e d b y :
~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks"
16369316|NCT00101686|Drug|miFL + bevacizumab|Day 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks
16369317|NCT00101686|Drug|Infusional 5-FU/LV with Irinotecan|Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
16369318|NCT00101686|Drug|Oral Capecitabine with Irinotecan|Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
16369319|NCT00101673|Drug|vildagliptin|
16369320|NCT00101660|Drug|Dasatinib|Tablets; oral; 70 mg BID, depending on response
16369321|NCT00101647|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure
16369322|NCT00101634|Drug|Paliperidone palmitate|
16369323|NCT00101621|Drug|M40403|
16369324|NCT00101608|Drug|vinflunine|solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
16369325|NCT00101595|Drug|Dasatinib|Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
16369326|NCT00101582|Drug|Placebo|
16369327|NCT00101582|Drug|palifermin|
16369328|NCT00101582|Drug|cisplatin chemotherapy|Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.
16369329|NCT00101582|Radiation|Radiotherapy|Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
16369330|NCT00101569|Drug|Aripiprazole|Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
16369331|NCT00101569|Drug|Aripiprazole|Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
16369332|NCT00101543|Device|Electrical Stimulation with Intramuscular Electrodes|
16369333|NCT00101543|Procedure|Body Weight Supported Treadmill Training|
16369334|NCT00101491|Behavioral|Health Communication DVD video|Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions
16369335|NCT00101452|Drug|S-adenosyl-l-methionine|1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
16369336|NCT00101452|Drug|Escitalopram|10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
16369337|NCT00101452|Drug|Placebo|placebo capsules look like escitalopram capsules and SAMe capsules
16369338|NCT00101439|Drug|ezetimibe|
16369339|NCT00101439|Drug|Comparator: placebo|
16369340|NCT00101426|Drug|ranirestat, (AS-3201)|
16369341|NCT00101413|Drug|Sorafenib (Nexavar, BAY43-9006)|BAY43-9006 400 mg bid X 28 day cycles [Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.
16369342|NCT00101400|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
16369343|NCT00101387|Other|Lumbar PENS + General Conditioning and Aerobic Exercise|As above
16369344|NCT00101387|Other|Lumbar PENS|As above
16369345|NCT00101387|Other|Control Lumbar PENS|Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
16369346|NCT00101387|Other|Control PENS + exercise|as above
16369347|NCT00101374|Drug|Leflunomide|
16369348|NCT00101361|Drug|Oxandrolone|Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.
16369349|NCT00101361|Drug|Placebo|Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.
16369350|NCT00101348|Drug|erlotinib hydrochloride|Given orally
16369351|NCT00101348|Biological|cetuximab|Given IV
16369352|NCT00101348|Biological|bevacizumab|Given IV
16369353|NCT00101348|Other|laboratory biomarker analysis|Correlative studies
16369354|NCT00101335|Drug|celecoxib|
16369355|NCT00101309|Biological|aldesleukin|
16369356|NCT00101309|Biological|autologous EBV-transformed B lymphoblastoid-tumor fusion cell vaccine|
16369357|NCT00101309|Biological|therapeutic autologous lymphocytes|
16369358|NCT00101296|Drug|tipifarnib|Given orally
16369359|NCT00101296|Other|pharmacological study|Correlative studies
16369360|NCT00101296|Other|laboratory biomarker analysis|Correlative studies
16369362|NCT00101283|Drug|gemcitabine hydrochloride|1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle
16369363|NCT00101283|Drug|carboplatin|Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle
16369364|NCT00101270|Drug|irinotecan hydrochloride|Given IV
16369365|NCT00101270|Drug|oxaliplatin|Given IV
16369366|NCT00101257|Biological|therapeutic autologous lymphocytes|
16369367|NCT00101244|Drug|ispinesib|Given IV
16369368|NCT00101244|Other|laboratory biomarker analysis|Correlative studies
16369369|NCT00101244|Other|pharmacological study|Correlative studies
16369370|NCT00101231|Drug|alvocidib|Given IV
16369371|NCT00101205|Drug|oxaliplatin|Given IV
16369372|NCT00101205|Drug|etoposide|Given IV
16369373|NCT00101192|Biological|cetuximab|
16369374|NCT00101192|Drug|cisplatin|
16369375|NCT00101179|Drug|Azacitidine|Given SC
16369376|NCT00101179|Drug|Entinostat|Given orally
16369377|NCT00101166|Biological|Bystander-Based Autologous Tumor Cell Vaccine|The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.
16369378|NCT00101153|Drug|cytarabine|
16369379|NCT00101153|Drug|daunorubicin hydrochloride|
16369380|NCT00101153|Drug|tipifarnib|
16369381|NCT00101140|Drug|anti-thymocyte globulin|
16369382|NCT00101140|Drug|fludarabine phosphate|
16369383|NCT00101140|Drug|thiotepa|
16369384|NCT00101140|Procedure|biological therapy|
16369385|NCT00101140|Procedure|bone marrow ablation with stem cell support|
16369386|NCT00101140|Procedure|chemotherapy|
16369387|NCT00101140|Procedure|non-specific immune-modulator therapy|
16369388|NCT00101140|Procedure|peripheral blood stem cell transplantation|
16369389|NCT00101140|Procedure|radiation therapy|
16369390|NCT00101127|Biological|filgrastim|
16369391|NCT00101127|Biological|pegfilgrastim|
16369392|NCT00101127|Drug|docetaxel|
16369393|NCT00101127|Drug|gemcitabine hydrochloride|
16369394|NCT00101114|Drug|sorafenib tosylate|Given PO
16369395|NCT00101114|Biological|recombinant interferon alfa-2b|Given SC
16369396|NCT00101114|Other|laboratory biomarker analysis|Optional correlative studies
16369397|NCT00101101|Drug|Cyclophosphamide|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
16369398|NCT00101101|Drug|Doxorubicin|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
16369399|NCT00101101|Drug|Vincristine|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
16369400|NCT00101101|Drug|Prednisone|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
16369401|NCT00101101|Drug|Dexamethasone|Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
16369402|NCT00101101|Biological|Autologous Tumor Cell-Based Vaccine|Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
16369403|NCT00101101|Drug|IL-2|Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
16369404|NCT00101088|Drug|imatinib mesylate|Given orally
16369405|NCT00101088|Drug|temsirolimus|Given IV
16369406|NCT00101088|Other|laboratory biomarker analysis|Correlative studies
16369407|NCT00101075|Drug|Capecitabine|
16369408|NCT00101075|Drug|Oxaliplatin|
16369409|NCT00101062|Drug|celecoxib|
16369410|NCT00101062|Drug|letrozole|
16369411|NCT00101036|Drug|lapatinib ditosylate|Given PO
16369412|NCT00101036|Other|laboratory biomarker analysis|Correlative studies
16369413|NCT00101010|Biological|Filgrastim|5 mcg/kg, SC daily, start 24 hours after chemotherapy
16369414|NCT00101010|Biological|Pegfilgrastim|6 mg SC one time (24 hours after chemotherapy)
16369415|NCT00101010|Biological|Rituximab|375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st
16369416|NCT00101010|Drug|Cyclophosphamide|750 mg/m^2 IVPB on day 1
16369417|NCT00101010|Drug|Pegylated liposomal doxorubicin hydrochloride|40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
16369418|NCT00101010|Drug|Prednisone|40 mg/m^2 oral days 1 - 5.
16369419|NCT00101010|Drug|Vincristine Sulfate|2 mg IV, day 1
16369420|NCT00100997|Drug|tanespimycin|
16369421|NCT00100984|Drug|FUZEON [enfuvirtide]|
16369422|NCT00100971|Drug|autologous tumor cell vaccine|
16369423|NCT00100971|Drug|therapeutic autologous dendritic cells|
16369424|NCT00100971|Procedure|tumor cell-derivative vaccine therapy|
16369425|NCT00100958|Drug|indole-3-carbinol|
16369426|NCT00100945|Drug|gefitinib|
16369427|NCT00100932|Drug|E7389 28 Day Cycle|E7389 1.4 mg/m^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.
16369428|NCT00100932|Drug|E7389 21 Day Cycle|E7389 1.4 mg/m^2 IV bolus on Days 1 and 8 of a 21 day cycle.
16369429|NCT00100906|Drug|IL-2|Immunotherapy with interleukin-2
16369430|NCT00100906|Drug|ATRA|
16369431|NCT00100893|Dietary Supplement|IH636 grape seed proanthocyanidin extract|Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage
16369432|NCT00100880|Drug|lenalidomide|Given PO
16369433|NCT00100880|Procedure|perfusion-weighted magnetic resonance imaging|Correlative studies
16369434|NCT00100880|Procedure|diffusion-weighted magnetic resonance imaging|Correlative studies
16369435|NCT00100880|Other|laboratory biomarker analysis|Correlative studies
16369436|NCT00100854|Drug|erlotinib hydrochloride|Given orally
16369437|NCT00100854|Drug|fulvestrant|Given intramuscularly
16369438|NCT00100841|Biological|cetuximab|Given IV
16369439|NCT00100841|Biological|bevacizumab|Given IV
16369440|NCT00100841|Drug|oxaliplatin|Given IV
16369441|NCT00100841|Drug|leucovorin calcium|Given IV
16369442|NCT00100841|Drug|fluorouracil|Given IV
16369443|NCT00100828|Drug|irinotecan hydrochloride|
16369444|NCT00100815|Biological|bevacizumab|30-90 minutes on day 1, every 21 days up to 12 months.
16369445|NCT00100815|Drug|capecitabine|twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
16369446|NCT00100815|Drug|gemcitabine hydrochloride|IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
16369447|NCT00100802|Drug|lomustine|Capsule
16369448|NCT00100802|Drug|temozolomide|Capsule
16369449|NCT00100802|Procedure|adjuvant therapy|
16369450|NCT00100802|Radiation|radiation therapy|
16369451|NCT00100789|Drug|gemcitabine|3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
16369452|NCT00100789|Drug|paclitaxel|150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
16369453|NCT00100776|Drug|Olanzapine|
16369454|NCT00100750|Drug|Gemcitabine Hydrochloride|Given IV
16369455|NCT00100750|Drug|Tipifarnib|Given PO
16369456|NCT00100750|Other|Laboratory Biomarker Analysis|Correlative studies
16369457|NCT00100737|Drug|interleukin-2|
16369458|NCT00100737|Drug|rituximab|
16369459|NCT00100724|Biological|rPA102|
16369460|NCT00100711|Drug|Motexafin Gadolinium|
16369461|NCT00100698|Drug|recombinant human growth hormone|growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
16369462|NCT00100698|Drug|placebo|placebo subcutaneously once a day, 18 months
16369463|NCT00100685|Drug|Volociximab (anti-α5β1 integrin monoclonal antibody)|Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
16369464|NCT00100672|Drug|LErafAON-ETU|
16369465|NCT00100659|Drug|Pegylated Interferon/ribavirin|
16369466|NCT00100646|Behavioral|Structured treatment interruption|Interruptions in treatment will last 2, 4, and 8 weeks in between 16-week periods of ART
16369467|NCT00100646|Drug|Lamivudine|300 mg tablet taken orally daily
16369468|NCT00100646|Drug|Lopinavir/Ritonavir|400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
16369469|NCT00100646|Drug|Stavudine|Dosage dependent on weight
16369470|NCT00100646|Biological|Rabies de novo antigen|Vaccine injected intramuscularly
16369471|NCT00100633|Drug|CpG7909 oligodeoxynucleotides (ODN)|
16369472|NCT00100633|Biological|Hepatitis B virus vaccine|
16369473|NCT00100620|Drug|Zoledronic Acid|
16369474|NCT00100607|Drug|AAE581|
16369475|NCT00100594|Drug|Efavirenz|
16369476|NCT00100594|Drug|Lamivudine/zidovudine|
16369477|NCT00100581|Drug|Efavirenz|
16369478|NCT00100581|Drug|Lamivudine|
16369479|NCT00100581|Drug|Lopinavir/ritonavir|
16369480|NCT00100581|Drug|Pegylated interferon alfa-2a|
16369481|NCT00100581|Drug|Ribavirin|
16369482|NCT00100581|Drug|Tenofovir disoproxil fumarate|
16369483|NCT00100568|Drug|Efavirenz|600 mg tablet taken orally daily
16369484|NCT00100568|Drug|Lamivudine/zidovudine|150mg lamivudine/300mg zidovudine tablet taken orally twice daily
16369485|NCT00100555|Drug|zoledronic acid|
16369486|NCT00100542|Behavioral|Psychiatric interviews|Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
16369487|NCT00100477|Drug|Topotecan|
16369488|NCT00100477|Drug|Mitozantrone|
16369489|NCT00100477|Drug|Etoposide|
16369490|NCT00100464|Drug|Paroxetine|
16369491|NCT00100464|Drug|5HTP|
16369492|NCT00100451|Procedure|exercise|
16369493|NCT00100425|Procedure|Viceral Perception Testing|
16369494|NCT00100412|Drug|Graded dobutamine infusions|
16369495|NCT00100412|Drug|Graded phenylephrine injections|
16369496|NCT00100412|Behavioral|Psychosocial challenge involving socioevaluative public speaking|
16369497|NCT00100399|Biological|Fluarix|
16369498|NCT00100386|Procedure|Intensive Control Strategy|
16369499|NCT00100386|Behavioral|Standard Control Strategy|
16369500|NCT00100373|Drug|RSV challenge material|
16369501|NCT00100347|Drug|PPI-2458|
16369502|NCT00100334|Drug|PPI-1019 (APAN)|
16369503|NCT00100308|Drug|Unfractioned heparin|Low-dose continuous-infusion, 500 units/hour per seven days
16369504|NCT00100308|Drug|saline|Saline placebo
16369505|NCT00100295|Drug|Hypericum perforatum|300 mg capsule taken three times a day
16369506|NCT00100295|Other|Placebo|300 mg given three times a day, containing rice protein powder
16369507|NCT00100282|Drug|PPI-1019 (APAN)|
16369508|NCT00100269|Drug|Menevit anti-oxidant|
16369509|NCT00100256|Drug|Rhenium (Re 188 P2045, BAY86-5284)|Infusion once only
16369511|NCT00100230|Drug|docosahexaenoic acid OR corn/soy oil placebo|daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial
16369512|NCT00100191|Procedure|uterine artery embolization|
16369513|NCT00100191|Procedure|hysterectomy|
16369514|NCT00100178|Drug|Mycophenolate mofeteil (MMF)|
16369515|NCT00100178|Drug|Daclizumab (DZB)|
16369516|NCT00100178|Drug|Placebo control for Mycophenolate mofeteil (MMF)|Placebo pills taken orally
16369517|NCT00100178|Drug|Placebo control for Daclizumab (DZB)|saline intravenous infusions
16369518|NCT00100165|Drug|Placebo|Placebo by mouth twice a day for 4 weeks
16369519|NCT00100165|Drug|3-(2,4 dimethoxybenzylidene anabaseine) 150 mg|3-(2,4 dimethoxybenzylidene) 150 mg by mouth twice a day for 4 weeks
16369520|NCT00100165|Drug|3-(2,4 dimethoxybenzylidene anabaseine) 75 mg|3-(2,4 dimethoxybenzylidene) 75 mg by mouth twice a day for 4 weeks
16369521|NCT00100152|Drug|MK0752, (Notch Inhibitor)|
16369522|NCT00100139|Drug|Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU)|
16369523|NCT00100139|Drug|Paclitaxel for injection (Taxol)|
16369524|NCT00100126|Drug|Amoxicillin Pulsatile Release Multiparticluate Sprinkle|
16369525|NCT00100113|Drug|GBR 12909|
16369526|NCT00100100|Drug|Modafinil|
16369527|NCT00100087|Device|Ocular Brachytherapy|
16369528|NCT00100074|Drug|Lobeline|
16369529|NCT00100061|Drug|Cranberry juice|liquid juice taken daily
16369530|NCT00100061|Dietary Supplement|Cranberry Juice|Taken orally
16369531|NCT00100061|Dietary Supplement|Placebo cranberry juice|Placebo comparitor
16369532|NCT00100048|Drug|Comparator: MK0518 monotherapy|MK0518 twice daily for 10 days
16369533|NCT00100048|Drug|Comparator: MK0518 combination therapy|MK0518 twice daily for 48 weeks
16369534|NCT00100048|Drug|Comparator: efavirenz|efavirenz 600 mg every night at bedtime for 48 weeks
16369535|NCT00100048|Drug|Comparator: tenofovir|tenofovir 300 mg daily for 48 weeks
16369536|NCT00100048|Drug|Comparator: lamivudine|lamivudine 300 mg daily for 48 weeks
16369537|NCT00100048|Drug|Placebo monotherapy|Placebo to MK0518 twice daily
16369538|NCT00100035|Procedure|Polarity therapy|
16369539|NCT00100009|Drug|TAC-PF|
16369540|NCT00100009|Drug|Triamcinolone Acetonide|
16369541|NCT00099996|Drug|SCH-58235|
16369542|NCT00099996|Drug|Ezetimibe|
16369543|NCT00099983|Drug|Risperidone|Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.
16369544|NCT00099983|Drug|Placebo|Placebo
16369545|NCT00099970|Drug|M200 (volociximab) in Combination with Dacarbazine (DTIC)|
16369546|NCT00099957|Drug|vildagliptin|
16369547|NCT00099944|Drug|vildagliptin|
16369548|NCT00099944|Drug|Glimepiride|Glimepiride 4 mg qd
16369549|NCT00099944|Drug|LAF237 placebo|
16369550|NCT00099931|Drug|vildagliptin|
16369551|NCT00099918|Drug|vildagliptin|
16369552|NCT00099905|Drug|vildagliptin|
16369553|NCT00099892|Drug|vildagliptin|
16369554|NCT00099879|Drug|BMS-275183|
16369555|NCT00099866|Drug|vildagliptin|
16369556|NCT00099866|Drug|Metformin Comparator|
16369557|NCT00099853|Drug|Vildagliptin|Vildagliptin 50 mg tablets
16369558|NCT00099853|Drug|pioglitazone|pioglitazone 45 mg qd
16369559|NCT00099853|Drug|Placebo|Vildagliptin matching placebo
16369560|NCT00099840|Procedure|Procalcitonin guided antibiotic therapy|
16369561|NCT00099827|Behavioral|Education|Individuals will receive information about depression
16369562|NCT00099814|Procedure|Two different loop designs which deliver distinctive forces|
16369563|NCT00099801|Drug|FTY720|
16369564|NCT00099788|Drug|Ranolazine|IV to oral transition.
16369565|NCT00099788|Drug|Placebo|IV to oral transition.
16369566|NCT00099775|Drug|Caspofungin|
16369567|NCT00099749|Drug|FTY 720|
16369568|NCT00099736|Drug|FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids|FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
16369569|NCT00099736|Drug|FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids|FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
16369570|NCT00099736|Drug|MMF 2 g + full-dose Neoral (FDN) + corticosteroids|mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
16369571|NCT00099723|Drug|VSL#3|
16369572|NCT00099710|Dietary Supplement|Curcumin C3 Complex|
16369573|NCT00099697|Drug|DHEA|
16369574|NCT00099684|Drug|Ezetimibe|
16369575|NCT00099671|Drug|Recombinant human interleukin-7|
16369576|NCT00099658|Biological|Pneumococcal polysaccharide-protein conjugate vaccine|Injection administered three times before the age of 24 weeks
16369577|NCT00099645|Drug|Mifepristone|
16369578|NCT00099632|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate|200mg/300mg as one tablet taken orally once daily
16369579|NCT00099632|Drug|Lamivudine/Zidovudine|150mg/300mg as one tablet taken orally twice daily
16369580|NCT00099632|Drug|Lopinavir/Ritonavir|133.3mg/33.3mg as three capsules taken orally twice daily
16369581|NCT00099632|Drug|single dose Nevirapine|one 200 mg tablet taken orally
16369582|NCT00099619|Drug|exenatide/insulin glargine|Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
16369583|NCT00099619|Drug|insulin glargine/exenatide|Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
16369584|NCT00099606|Drug|Dasatinib|Tablets, Oral, Dose Finding Study - Range was 35 mg BID, 5 days on/2 days off - 120 mg BID Continuous Daily Dosing, Once daily, Patients remained on study until treatment discontinuation due to unacceptable toxicity, disease progression or death.
16369585|NCT00099593|Biological|Autologous Dendritic Cell Vaccine|
16369586|NCT00099580|Drug|AC2592|continuous subcutaneous infusion (via pump), dose based on subject body weight
16369587|NCT00099580|Drug|placebo|continuous subcutaneous infusion (via pump), dose based on subject body weight
16369588|NCT00099554|Drug|Etanercept|
16369589|NCT00099541|Drug|zoledronic acid|
16369590|NCT00099528|Drug|REN-1654|
16369591|NCT00099515|Drug|LY041001 (HIIP)|Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
16369592|NCT00099515|Drug|LY041001 (HIIP)|Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
16369593|NCT00099502|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|250mcg administered s.c. every other day
16369594|NCT00099502|Drug|Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)|500mcg administered s.c. every other day
16369595|NCT00099502|Drug|Copaxone|20 mg administered s.c. once daily.
16369596|NCT00099489|Drug|Interferon Beta-1a|
16369597|NCT00099476|Behavioral|Effects of dark chocolate|
16369598|NCT00099463|Procedure|Blood Test|
16369599|NCT00099463|Procedure|Urine Test|
16369600|NCT00099463|Procedure|Physical Exam|
16369601|NCT00099463|Drug|Vaccine|
16369602|NCT00099463|Drug|VRC-SRSDNA015-00-VP|
16369603|NCT00099450|Drug|INS50589 Intravenous Infusion|
16369604|NCT00099437|Drug|Fulvestrant|intramuscular injection
16369605|NCT00099424|Behavioral|High-intensity exercise training|
16369606|NCT00099385|Behavioral|Social Development Instruction|Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.
16369607|NCT00099359|Drug|Zidovudine|Given for 6 weeks. 12mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams
16369608|NCT00099359|Drug|Nevirapine (NVP)|"Standard of Care (Zidovudine) plus
~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :
~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
16369609|NCT00099359|Drug|Epivir (3TC)|"Stand of care (Zidovudine) plus
~3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND
~NFV, given for 2 weeks:
~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
16369610|NCT00099359|Drug|Nelfinavir (NFV)|200 mg BID if birth weight (BW) > 3000 grams for 2 weeks;150 mg BID if BW > 2000-3000 grams for 2 weeks; 100 mg BID BW </= 2000 grams for 2 weeks
16369611|NCT00099346|Drug|MK0457, VX-680 (Aurora Kinase Inhibitor)|
16369612|NCT00099333|Drug|exenatide|Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
16369613|NCT00099333|Drug|Insulin|Insulin will be taken according to the subject's current regimen
16369614|NCT00099320|Drug|exenatide|After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
16369615|NCT00099320|Drug|Placebo|After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.
16369616|NCT00099294|Drug|Glufosfamide|
16369617|NCT00099281|Drug|YMB 1002|
16369618|NCT00099268|Drug|Carbidopa/levodopa/entacapone|Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
16369619|NCT00099268|Drug|Immediate release carbidopa/levodopa|Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
16369620|NCT00099255|Drug|SGN-30|
16369621|NCT00099242|Drug|rivastigmine transdermal patch|
16369622|NCT00099229|Drug|Licarbazepine|
16369623|NCT00099216|Drug|Rivastigmine|
16369624|NCT00099203|Drug|ibandronate [Bondronat]|6mg iv on days 1-3, and every 3-4 weeks
16369625|NCT00099203|Drug|zoledronic acid|4mg iv on day 1 and every 3-4 weeks
16369626|NCT00099190|Drug|ARQ 501|
16369627|NCT00099177|Drug|ibandronate [Bondronat]|6mg iv on days 1-3, and 50mg po from day 22 to week 24
16369628|NCT00099177|Drug|zoledronic acid|4mg iv on day 1, and every 3-4 weeks
16369629|NCT00099164|Drug|17 alpha-hydroxyprogesterone caproate (17P)|Study coded medication is 250 mg of 17P as a 1 ml intramuscular injection (or 1 ml of placebo inert oil). Patients are seen weekly to administer the study drug through 34 weeks 6 days gestation or delivery, whichever occurs first.
16369630|NCT00099151|Behavioral|Caloric Restriction (CR)|
16369631|NCT00099151|Behavioral|Exercise|
16369632|NCT00099138|Behavioral|Caloric Restriction (CR)|
16369633|NCT00099138|Behavioral|Exercise|
16369634|NCT00099125|Drug|irinotecan hydrochloride|
16369635|NCT00099125|Drug|temozolomide|
16369636|NCT00099125|Procedure|adjuvant therapy|
16369637|NCT00099125|Radiation|radiation therapy|
16369638|NCT00099112|Genetic|microarray analysis|
16369639|NCT00099112|Procedure|biopsy|
16369640|NCT00099112|Procedure|evaluation of cancer risk factors|
16369641|NCT00099099|Behavioral|Caloric Restriction (CR)|
16369642|NCT00099086|Drug|Bicalutamide|Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
16369643|NCT00099086|Drug|docetaxel|Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2
16369644|NCT00099086|Drug|GnRh analog|"A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
~Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)"
16369645|NCT00099086|Radiation|radiotherapy|External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.
16369721|NCT00098722|Drug|Maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken twice daily
16373632|NCT00083538|Drug|Etoposide|
16369646|NCT00099060|Drug|lapatinib ditosylate|"For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs):
~Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6).
~Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d.
~For patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs):
~• Phase II: 750 mg GW572016 po b.i.d.
~For all patients:
~• Dose reductions as required based on adverse events."
16369647|NCT00099047|Drug|celecoxib|Given PO
16369648|NCT00099047|Drug|placebo|Given PO
16369649|NCT00099047|Other|laboratory biomarker analysis|Correlative studies
16369650|NCT00099021|Drug|pioglitazone hydrochloride|Given PO
16369651|NCT00099008|Dietary Supplement|Genistein|oral Genistein twice daily on days 1-84
16369652|NCT00099008|Dietary Supplement|Placebo|oral Placebo twice daily on days 1-84
16369653|NCT00098995|Drug|cisplatin|
16369654|NCT00098995|Drug|tirapazamine|
16369655|NCT00098995|Radiation|brachytherapy|
16369656|NCT00098995|Radiation|radiation therapy|
16369657|NCT00098982|Drug|bortezomib|
16369658|NCT00098982|Drug|fluorouracil|
16369659|NCT00098982|Drug|leucovorin calcium|
16369660|NCT00098982|Drug|oxaliplatin|
16369661|NCT00098969|Drug|resveratrol|
16369662|NCT00098956|Drug|topotecan hydrochloride|Given IV
16369663|NCT00098956|Drug|7-hydroxystaurosporine|Given IV
16369664|NCT00098943|Biological|CNGRC peptide-TNF alpha conjugate|
16369665|NCT00098917|Drug|autologous tumor cell vaccine|
16369666|NCT00098917|Drug|therapeutic autologous dendritic cells|
16369667|NCT00098917|Procedure|adjuvant therapy|
16369668|NCT00098917|Procedure|biological therapy|
16369669|NCT00098917|Procedure|conventional surgery|
16369670|NCT00098917|Procedure|surgery|
16369671|NCT00098917|Procedure|tumor cell derivative vaccine|
16369672|NCT00098917|Procedure|vaccine therapy|
16369673|NCT00098891|Drug|entinostat|Given orally
16369674|NCT00098891|Drug|isotretinoin|Given orally
16369675|NCT00098878|Drug|carboplatin|
16369676|NCT00098865|Drug|temozolomide|The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
16369677|NCT00098865|Drug|thalidomide|Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
16369678|NCT00098852|Drug|rosiglitazone maleate|
16369679|NCT00098839|Drug|L-asparaginase|Given IM
16369680|NCT00098839|Drug|doxorubicin hydrochloride|Given IV
16369681|NCT00098839|Drug|therapeutic hydrocortisone|40 mg/m2/day PO divided BID or TID
16369682|NCT00098839|Drug|vincristine sulfate|Given IV
16369683|NCT00098839|Biological|epratuzumab|Given IV
16369684|NCT00098839|Drug|cytarabine|Given IT
16369685|NCT00098839|Drug|prednisone|Given orally
16369686|NCT00098839|Drug|pegaspargase|Given IM
16369687|NCT00098839|Drug|dexrazoxane hydrochloride|Given IV
16369688|NCT00098839|Drug|methotrexate|Given IT
16369689|NCT00098839|Drug|etoposide|Given IV
16369690|NCT00098839|Drug|cyclophosphamide|Given IV
16369691|NCT00098839|Drug|leucovorin calcium|Given IV
16369692|NCT00098839|Biological|filgrastim|Given SC
16369693|NCT00098826|Drug|ispinesib|Given IV
16369694|NCT00098826|Other|laboratory biomarker analysis|Correlative studies
16369695|NCT00098826|Other|pharmacological study|Correlative studies
16369696|NCT00098813|Drug|romidepsin|Given IV
16369697|NCT00098813|Other|laboratory biomarker analysis|Correlative studies
16369698|NCT00098813|Procedure|positron emission tomography|Correlative studies
16369699|NCT00098800|Drug|fenretinide|
16369700|NCT00098787|Biological|bevacizumab|Given IV
16369701|NCT00098787|Drug|fluorouracil|Given IV
16369702|NCT00098787|Drug|irinotecan hydrochloride|Given IV
16369703|NCT00098787|Drug|leucovorin calcium|Given IV
16369704|NCT00098787|Drug|Oxaliplatin|Given IV
16369705|NCT00098774|Biological|filgrastim|5 mcg/kg subQ injection daily Day 14 until ANC > or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)
16369706|NCT00098774|Biological|rituximab|375 mg/sq m IV infusion (max rate of 400 mg/hr) on Days 3, 10, 17, & 24 of Cycle 1 nad Days 3 & 10 of Cycle 2
16369707|NCT00098774|Drug|cytarabine|2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6
16369708|NCT00098774|Drug|etoposide|5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6
16369709|NCT00098774|Drug|leucovorin calcium|100 mg/sq m IV infusion q 6 hrs starting 24 hrs after ea MTX dose until serum MTX < or = 0.05uM Cycles 1-5.
16369710|NCT00098774|Drug|methotrexate|8 g/sq m IV infusion over 4 hrs Days 1 & 15 Cycles 1, 2, & 3; Day 15 Cycle 4 and Day 1 Cycle 5.
16369711|NCT00098774|Drug|temozolomide|150 mg/sq m PO Days 7-11 Cycles 1-5.
16369712|NCT00098761|Drug|laromustine|This is a dose escalation study. Participants receive 20, 30, 45, 60, 78, 103, 137, 182, or 242 mg/m2/day intravenously over 30 minutes for 5 consecutive days every 6 weeks up to 48 weeks.
16369713|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
16369714|NCT00098748|Drug|maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken once daily
16369715|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
16369716|NCT00098748|Drug|maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken twice daily
16369717|NCT00098748|Drug|Optimized Background Therapy (OBT)|OBT (3-6 drugs based on treatment history and resistance testing)
16369718|NCT00098735|Drug|FTY720|
16369719|NCT00098722|Drug|Maraviroc (UK-427,857)|maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
16369720|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
16369722|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
16369723|NCT00098722|Drug|optimized background therapy|[OBT (3-6 drugs based on treatment history and resistance testing)]
16369724|NCT00098709|Device|Fetal pulse oximeter|
16369725|NCT00098683|Drug|amifostine trihydrate|
16369726|NCT00098670|Biological|alemtuzumab|Given SC
16369727|NCT00098670|Biological|rituximab|Given IV
16369728|NCT00098670|Drug|fludarabine phosphate|Given IV
16369729|NCT00098631|Drug|lapatinib ditosylate|Given orally
16369730|NCT00098631|Other|laboratory biomarker analysis|Correlative studies
16369731|NCT00098618|Drug|sorafenib tosylate|Given orally
16369732|NCT00098618|Biological|recombinant interferon alfa|Given orally
16369733|NCT00098618|Other|laboratory biomarker analysis|Correlative studies
16369734|NCT00098605|Drug|lapatinib ditosylate|Given orally
16369735|NCT00098605|Other|laboratory biomarker analysis|Correlative studies
16369736|NCT00098605|Procedure|quality-of-life assessment|Ancillary studies
16369737|NCT00098605|Other|questionnaire administration|Ancillary studies
16369738|NCT00098579|Drug|alvocidib|Given IV
16369739|NCT00098579|Drug|doxorubicin hydrochloride|Given IV
16369740|NCT00098553|Drug|everolimus|
16369741|NCT00098540|Drug|sorafenib tosylate|Given orally
16369742|NCT00098540|Other|laboratory biomarker analysis|Correlative studies
16369743|NCT00098527|Drug|romidepsin|Given IV
16369744|NCT00098527|Other|laboratory biomarker analysis|Correlative studies
16369745|NCT00098514|Drug|talotrexin ammonium|
16369746|NCT00098501|Drug|pelitinib|
16369747|NCT00098501|Drug|temsirolimus|Given PO
16369748|NCT00098488|Drug|tanespimycin|Given IV
16369749|NCT00098488|Biological|rituximab|Given IV
16369750|NCT00098475|Drug|Dexamethasone|Given PO
16369751|NCT00098475|Other|Laboratory Biomarker Analysis|Optional correlative studies
16369752|NCT00098475|Drug|Lenalidomide|Given PO
16369753|NCT00098475|Drug|Thalidomide|Given PO
16369754|NCT00098462|Drug|gefitinib|
16369755|NCT00098462|Drug|sirolimus|
16369756|NCT00098436|Drug|laromustine|
16369757|NCT00098436|Drug|temozolomide|
16369758|NCT00098423|Drug|tanespimycin|Given IV
16369759|NCT00098423|Drug|cytarabine|Given IV
16369760|NCT00098397|Drug|romidepsin|Given IV
16369761|NCT00098397|Other|laboratory biomarker analysis|Optional correlative studies
16369762|NCT00098384|Drug|rifaximin|
16369763|NCT00098371|Drug|alvocidib|
16369764|NCT00098358|Drug|Zileuton|
16369765|NCT00098345|Drug|ZD6474 (vandetanib)|oral once daily tablet
16369766|NCT00098332|Drug|forodesine hydrochloride|
16369767|NCT00098319|Drug|Folic acid (0.4mg vs. 4.0mg)|
16369768|NCT00098306|Drug|Maraviroc (UK-427,857)|Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
16369769|NCT00098306|Drug|Optimized Background Therapy|Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
16369770|NCT00098306|Drug|Optimized Background Therapy|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
16369771|NCT00098306|Drug|Placebo|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
16369772|NCT00098306|Drug|Optimized Background Therapy|Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment.
16369773|NCT00098293|Drug|Maraviroc + Zidovudine/Lamivudine|maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
16369774|NCT00098293|Drug|Efavirenz + Zidovudine/Lamivudine|efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
16369775|NCT00098293|Drug|Maraviroc (UK-427,857) + Zidovudine/Lamivudine|maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
16369776|NCT00098280|Drug|Eculizumab|
16369777|NCT00098254|Drug|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
16369778|NCT00098241|Drug|Certican|
16369779|NCT00098228|Drug|QAB149|
16369780|NCT00098215|Behavioral|Pediatric residency training on tobacco|
16369781|NCT00098202|Drug|Low phytic acid maize|
16369782|NCT00098202|Drug|Zinc|
16369783|NCT00098163|Biological|ALVAC-HIV vCP1521|One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12.
16369784|NCT00098163|Biological|ALVAC HIV-1 vCP1521|One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12.
16369785|NCT00098137|Drug|Olmesartan|
16369786|NCT00098124|Drug|milnacipran hydrochloride|
16369787|NCT00098111|Drug|azathioprine|
16369788|NCT00098098|Biological|rBV A/B|
16369789|NCT00098085|Biological|HSPPC-96|
16369791|NCT00098059|Drug|Famciclovir|Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
16369792|NCT00098046|Drug|famciclovir|
16369793|NCT00098033|Drug|clofarabine|
16369794|NCT00098020|Drug|Isotretinoin|
16369795|NCT00098007|Drug|Everolimus (Certican)|
16369836|NCT00097656|Other|multi-center, randomized, controled periodontal therapy|periodontal therapy
16369837|NCT00097643|Behavioral|exercise|
16369796|NCT00097981|Drug|Thalidomide|Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.
16369797|NCT00097981|Drug|Dexamethasone|Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
16369798|NCT00097981|Drug|DOXIL|DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.
16369799|NCT00097968|Drug|everolimus|
16369800|NCT00097955|Drug|aliskiren|
16369801|NCT00097942|Drug|memantine HCl|
16369802|NCT00097929|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months|
16369803|NCT00097916|Drug|memantine HCl|
16369804|NCT00097903|Drug|Karenitecin (BNP1350)|Phase 1 study,dose-escalation design
16369805|NCT00097890|Drug|Replagal (Agalsidase Alfa)|
16369806|NCT00097890|Drug|Replagal|
16369807|NCT00097877|Drug|biphasic insulin aspart|
16369808|NCT00097877|Drug|insulin glargine|
16369809|NCT00097851|Drug|docetaxel|
16369810|NCT00097851|Drug|PI-88|
16369811|NCT00097838|Biological|AVX101|Alphavirus replicon particle vaccine expressing HIV Gag antigen
16369812|NCT00097838|Other|placebo|phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
16369813|NCT00097825|Drug|Zoledronic Acid|
16369814|NCT00097812|Drug|zoledronic acid|
16369815|NCT00097799|Drug|Tipranavir|500 mg twice daily
16369816|NCT00097799|Drug|Ritonavir|200 mg twice daily
16369817|NCT00097786|Drug|Valsartan 160 mg + nateglinide 60 mg|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
16369818|NCT00097786|Drug|Valsartan 160 mg + nateglinide placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
16369819|NCT00097786|Drug|Nateglinide 60 mg + valsartan placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
16369820|NCT00097786|Drug|Valsartan placebo + nateglinide placebo|The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
16369821|NCT00097773|Drug|Tobramycin solution for inhalation (TOBI)|Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa.
16369822|NCT00097773|Drug|Oral placebo|Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily.
16369823|NCT00097773|Drug|Oral ciprofloxacin|Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.
16369824|NCT00097760|Drug|Natalizumab|Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
16369825|NCT00097760|Drug|Natalizumab|Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
16369826|NCT00097760|Drug|Placebo|Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
16369827|NCT00097747|Drug|Placebo|
16369828|NCT00097747|Drug|peginesatide|
16369829|NCT00097734|Drug|ertapenem|
16369830|NCT00097721|Drug|E7389|The first cohort of subjects were to receive E7389 1.4 mg/m^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.
16369831|NCT00097708|Drug|experimental anti-anxiety drug|
16369832|NCT00097695|Drug|Icatibant|30 mg (3mL) subcutaneous icatibant injection in the abdominal region
16369833|NCT00097695|Drug|Placebo|Solution for injection, matched to study drug Single dose: 3 mL
16369834|NCT00097669|Drug|Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo|multivitamin
16369835|NCT00097669|Other|Placebo|
16373633|NCT00083486|Drug|epoetin alfa|
16369838|NCT00097643|Behavioral|health promotion|
16369839|NCT00097630|Procedure|SAT: Spontaneous Awakening Trial|
16369840|NCT00097630|Procedure|SBT: Spontaneous Breathing Trial|
16369841|NCT00097604|Dietary Supplement|Valerian root extract|Valerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime
16369842|NCT00097591|Drug|Prasugrel|Administered orally
16369843|NCT00097591|Drug|Clopidogrel|Administered orally
16369844|NCT00097539|Biological|Somatrem|
16369845|NCT00097539|Biological|Somatropin|
16369846|NCT00097500|Drug|exenatide|subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
16369847|NCT00097500|Drug|Insulin glargine|subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
16369848|NCT00097500|Drug|Metformin|Patients usual dosage
16369852|NCT00097448|Drug|prednisone|Oral, 19 days
16369853|NCT00097448|Drug|methylprednisolone sodium succinate|Four intratympanic injections delivered to the middle ear over 2 weeks
16369854|NCT00097435|Drug|Albuferon|
16369855|NCT00097435|Drug|Ribavirin|
16369856|NCT00097422|Drug|OPT-80|
16369857|NCT00097409|Drug|Ispinesib|
16369858|NCT00097396|Biological|rF1V vaccine|
16369859|NCT00097383|Drug|ALIMTA plus Epirubicin|
16369860|NCT00097370|Drug|mepolizumab|Study Drug
16369861|NCT00097357|Drug|Apixaban|Tablets, Oral, 12 +/- 2 days
16369862|NCT00097357|Drug|Enoxaparin|Injection, SQ, Q12H, 12 +/- 2 days
16369863|NCT00097357|Drug|Warfarin|Tablets, Oral, QD, 12 +/- 2 days
16369864|NCT00097357|Drug|Enoxaparin Placebo|Injection, SQ, BID, 12 +/- 2 days
16369865|NCT00097357|Drug|Apixaban Placebo|Tablets, Oral, BID, 12 +/- 2 days
16369866|NCT00097344|Drug|Atamestane|
16369867|NCT00097344|Drug|Toremifene|
16369868|NCT00097344|Drug|Letrozole|
16369869|NCT00097344|Drug|Aromatase inhibition|
16369870|NCT00097344|Drug|Estrogen receptor blocker|
16369871|NCT00097344|Procedure|Hormone therapy|
16369872|NCT00097344|Procedure|Endocrine therapy|
16369873|NCT00097344|Procedure|Antiestrogen therapy|
16369874|NCT00097331|Drug|SB683699|
16369875|NCT00097318|Drug|Interferon beta-1a|
16369876|NCT00097305|Behavioral|Body-Oriented Therapy|
16369877|NCT00097305|Behavioral|Standardized Massage Therapy|
16369878|NCT00097279|Drug|biphasic insulin aspart|
16369879|NCT00097279|Drug|pioglitazone|
16369880|NCT00097279|Drug|metformin|
16369881|NCT00097266|Drug|Placebo|Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
16369882|NCT00097266|Drug|Aripiprazole|Tablets, oral, 15-30 mg, once daily, 12 weeks.
16369883|NCT00097266|Drug|Haloperidol|Capsule, oral, 5-15 mg, once daily, 12 weeks.
16369884|NCT00097253|Behavioral|Exposure to relaxant and stimulant odors|A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
16369885|NCT00097227|Biological|Cetuximab|"(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.
~A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B."
16369886|NCT00097227|Drug|Carboplatin|(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
16369887|NCT00097227|Drug|Paclitaxel|225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.
16369888|NCT00097214|Drug|Carboplatin|AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8.
16369889|NCT00097214|Biological|Cetuximab|400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8.
16369890|NCT00097188|Drug|rituximab|
16369891|NCT00097162|Procedure|Anodal stimulation|
16369892|NCT00097149|Procedure|Systematic pediatric care|
16369893|NCT00097123|Drug|Misoprostol|
16369894|NCT00097110|Drug|Vitamin C and E|
16369895|NCT00097097|Procedure|Neonatal Resuscitation|
16369896|NCT00097084|Drug|insulin detemir|
16369897|NCT00097084|Drug|insulin glargine|
16369898|NCT00097084|Drug|insulin aspart|
16369899|NCT00097071|Drug|insulin lispro|
16369900|NCT00097071|Drug|insulin aspart|
16369901|NCT00097045|Drug|omega interferon|
16369902|NCT00097045|Drug|Ribavirin|
16369903|NCT00097032|Drug|risperidone; quetiapine|
16369904|NCT00097019|Drug|bevacizumab|
16369905|NCT00096993|Drug|Placebo|Placebo was provided as a single-use formulation for infusion.
16369906|NCT00096993|Drug|Gemcitabine|Gemcitabine was provided as a solution for infusion.
16369907|NCT00096993|Drug|Pertuzumab|Pertuzumab was provided as a single-use formulation for infusion.
16369908|NCT00096980|Drug|Raptiva (efalizumab)|
16369909|NCT00096967|Drug|Avastin (bevacizumab)|
16369910|NCT00096954|Drug|omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
16369911|NCT00096954|Drug|placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
16369973|NCT00096421|Behavioral|Tight control of blood glucose levels|
16369912|NCT00096941|Drug|Pertuzumab|Pertuzumab was supplied as a single-use liquid formulation.
16369913|NCT00096915|Drug|Darbepoetin Alfa|"QM administration for 32 weeks, allowable doses:
~15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg"
16369914|NCT00096902|Procedure|Tilt table test|
16369915|NCT00096863|Drug|Ziprasidone|
16369916|NCT00096863|Drug|Haloperidol|
16369917|NCT00096863|Other|Placebo|
16369918|NCT00096850|Drug|Atazanavir|From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.
16369919|NCT00096850|Drug|Rifampin|From Days 1 to 27, participants will receive a 600 mg tablet orally daily.
16369920|NCT00096850|Drug|Ritonavir|From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.
16369921|NCT00096837|Drug|Motexafin Gadolinium Injection|
16369922|NCT00096824|Behavioral|Neurological assessment|All participants will undergo neurological examinations and neuropsychological assessments.
16369923|NCT00096811|Drug|Entecavir|Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.
16369924|NCT00096798|Drug|Ethyl-eicosapentanoic acid (ethyl-EPA)|
16369925|NCT00096785|Drug|entecavir|Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
16369926|NCT00096785|Drug|adefovir|Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks
16369927|NCT00096759|Behavioral|Tai Chi Chih|
16369928|NCT00096759|Behavioral|Relaxation training|
16369929|NCT00096746|Drug|LPV/RTV + 2NRTIs|Tablets, Oral, Variable, Twice daily, 48 weeks.
16369930|NCT00096746|Drug|LPV/RTV + 2NRTIs|Tablets, Oral, Variable, Twice daily, 48 weeks.
16369931|NCT00096720|Drug|levodopa|
16369932|NCT00096720|Drug|Mirapex (pramipexole)|
16369933|NCT00096720|Procedure|[123I]ß-CIT and SPECT imaging|
16369934|NCT00096707|Drug|2-deoxy-D-glucose (2DG)|
16369935|NCT00096694|Device|Levonorgestrel-releasing intrauterine device (IUD)|
16369936|NCT00096668|Drug|TOCOSOL(R) Paclitaxel|
16369937|NCT00096655|Drug|Infliximab|
16369938|NCT00096642|Behavioral|Cognitive Behavioral Therapy|Cognitive behaviour versus standard care
16369939|NCT00096629|Biological|human prostate-specific membrane antigen plasmid DNA vaccine|
16369940|NCT00096629|Biological|mouse prostate-specific membrane antigen plasmid DNA vaccine|
16369941|NCT00096616|Drug|Combivent® CFC MDI|
16369942|NCT00096616|Drug|Albuterol HFA MDI|
16369943|NCT00096603|Drug|Raptiva (efalizumab)|
16369944|NCT00096590|Other|coagulation study|
16369945|NCT00096590|Other|immunoenzyme technique|
16369946|NCT00096590|Other|laboratory biomarker analysis|
16369947|NCT00096590|Other|physiologic testing|
16369948|NCT00096590|Procedure|study of high risk factors|
16369949|NCT00096551|Drug|Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM)|
16369950|NCT00096551|Drug|Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM)|
16369951|NCT00096551|Drug|Recombinant Fowlpox-GM-CSF|
16369952|NCT00096538|Drug|valganciclovir|
16369953|NCT00096525|Drug|lenalidomide|
16369954|NCT00096512|Drug|sorafenib tosylate|Given orally
16369955|NCT00096512|Other|laboratory biomarker analysis|Correlative studies
16369956|NCT00096499|Drug|ispinesib|Given IV
16369957|NCT00096499|Other|pharmacological study|Correlative studies
16369958|NCT00096499|Other|laboratory biomarker analysis|Correlative studies
16369959|NCT00096486|Drug|everolimus|
16369960|NCT00096486|Drug|gefitinib|
16369961|NCT00096473|Drug|Donepezil hydrochloride|
16369962|NCT00096460|Drug|Cyclophosphamide and Rituximab|Prior to undergoing HSCT, all patients will receive Cyclophosphamide 4 gm/m2 with Rituximab 375 mg/m2 x 2 doses and G-CSF support.
16369963|NCT00096460|Drug|Filgrastim|Autologous HSCT patients will receive 10 mcg/kg/day and allogeneic HSCT patients will receive 5 mcg/kg/day subcutaneous (SQ) or intravenous (IV) starting 2 days after the initiation of Cyclophosphamide.
16369964|NCT00096460|Radiation|Chemotherapy or Radiation therapy|"Chemotherapy - BCNU 15 mg/kg IV x 1 dose to be administered over 2 hours on Day -6 pre-HSCT. VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4.
~Radiation - administered at a rate of < 20 cGy/min in one of the following doses; 120 cGy/fraction are administered at no less than 4-hour intervals three times/day or 2 times/day for a total of 10 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5), or doses of 150 cGy/fraction twice daily for a total of 8 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5). VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4 pre-HSCT.
~Cyclophosphamide 100 mg/kg IV x 1 dose to be administered over 2 hours on Day -2 pre-HSCT. G-CSF 5 mcg/kg SQ or IV to start on Day +5 post-HSCT and continue until ANC > 500/mm3 x 3 days."
16369965|NCT00096460|Drug|Non-myeloablative Conditioning regimen|Fludarabine 30 mg/m2 IV x 3 doses total to be administered daily over 30 minutes on Days -6, -5 and -4 pre-HSCT. Cyclophosphamide 750 mg/m IV x 3 doses total to be administered daily over 1 hour on Days -6, -5 and -4 pre-HSCT. Administer cyclophosphamide approximately 4 hours after start of fludarabine infusion. Rituximab 375 mg/m2 IV x 4 doses total to be administered on Days -13 and -6 pre HSCT and Days +1 and +8 post HSCT.
16369966|NCT00096460|Procedure|Allogeneic transplant|Infusion of G-CSF mobilized allogeneic hematopoietic stem cells
16369967|NCT00096460|Procedure|Autologous transplant|Infusion of G-CSF mobilized autologous hematopoietic stem cells
16369968|NCT00096460|Drug|Rituximab maintenance therapy|"Patients must have sufficiently recovered from autologous HSCT in order to receive rituximab maintenance therapy as specified below:
~Dose #1: Day +42 post-autologous HSCT Dose #2: Day +49 post-autologous HSCT Dose #3: Day +56 post-autologous HSCT Dose #4: Day +63 post-autologous HSCT"
16369969|NCT00096460|Drug|GVHD Prophylaxis|Tacrolimus 0.09 mg/kg/day PO, based on body weight formulas will start on Day -2 and continue until Day +90 post-HSCT. Tacrolimus (or cyclosporine, if applicable) will be given orally in a twice-daily divided dose. Methotrexate 5 mg/m2 Intravenous Pyelogram (IVP) will be administered on Days +1, +3 and +6 post-HSCT.
16369970|NCT00096447|Drug|lapatinib ditosylate|
16369971|NCT00096434|Drug|sorafenib tosylate|Given orally
16369972|NCT00096434|Other|laboratory biomarker analysis|Correlative studies
16369974|NCT00096421|Behavioral|Conventional control of glucose levels|
16369975|NCT00096408|Procedure|Total Abdominal Hysterectomy|For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
16369976|NCT00096408|Procedure|Total Laparoscopic Hysterectomy|The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.
16369977|NCT00096395|Drug|gemcitabine hydrochloride|Given IV
16369978|NCT00096395|Drug|sorafenib tosylate|Given orally
16369979|NCT00096395|Other|laboratory biomarker analysis|Correlative studies
16369980|NCT00096382|Biological|aldesleukin|high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week)
16369981|NCT00096382|Biological|filgrastim|10 mcg/kg/day daily subcutaneously until neutrophil count >1x10^9/1.
16369982|NCT00096382|Biological|therapeutic tumor infiltrating lymphocytes|Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
16369983|NCT00096382|Drug|cyclophosphamide|60 mg/kg/day x 2 days intravenously over 1 hour
16369984|NCT00096382|Drug|fludarabine phosphate|25 mg/m^2/day intravenous piggyback daily over 15-20 minutes for 5 days
16369985|NCT00096382|Radiation|radiation therapy|Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
16369986|NCT00096369|Drug|tamoxifen citrate|
16369987|NCT00096356|Dietary Supplement|CoQ10 & Vitamin E|
16369988|NCT00096356|Dietary Supplement|Placebo & Vitamin E|
16369989|NCT00096343|Drug|carboplatin|
16369990|NCT00096343|Drug|paclitaxel|
16369991|NCT00096330|Dietary Supplement|dietary intervention|oral folic acid supplementation once daily on days 57-84
16369992|NCT00096330|Dietary Supplement|folic acid|oral folic acid supplementation once daily on days 1-56.
16369993|NCT00096317|Drug|ixabepilone|
16369994|NCT00096317|Drug|ketoconazole|
16369995|NCT00096304|Drug|docetaxel|
16369996|NCT00096304|Drug|epirubicin hydrochloride|
16369997|NCT00096291|Other|Doxorubicin followed by Paclitaxel|"Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy:
~Doxorubicin followed by Paclitaxel Paclitaxel followed by Doxorubicin"
16369998|NCT00096291|Other|Paclitaxel followed by Doxorubicin|"Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy:
~Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin"
16369999|NCT00096278|Biological|Bevacizumab|Given IV
16370000|NCT00096278|Drug|Fluorouracil|Given IV
16370001|NCT00096278|Drug|Leucovorin Calcium|Given IV
16370002|NCT00096278|Drug|Oxaliplatin|Given IV
16370003|NCT00096265|Radiation|3-Dimensional Conformal Radiation Therapy|Patients undergo radiation therapy once daily for approximately 3 weeks
16370004|NCT00096265|Drug|Erlotinib Hydrochloride|Given orally
16370005|NCT00096265|Radiation|Stereotactic Radiosurgery|Patients undergo surgery after radiation therapy
16370006|NCT00096265|Drug|Temozolomide|Given orally
16370007|NCT00096239|Drug|CP-547,632|
16370008|NCT00096226|Drug|Induction Carboplatin|
16370009|NCT00096226|Drug|Induction Paclitaxel|
16370010|NCT00096226|Procedure|Resection|
16370011|NCT00096226|Drug|Consolidation Carboplatin|
16370012|NCT00096226|Radiation|Radiation Therapy|
16370013|NCT00096226|Drug|Consolidation Paclitaxel|
16370014|NCT00096213|Procedure|conventional surgery|surgery
16370015|NCT00096200|Drug|Carboplatin|Given IV
16370016|NCT00096200|Drug|Paclitaxel|Given IV
16370017|NCT00096200|Drug|Sorafenib Tosylate|Given orally
16370018|NCT00096187|Drug|pemetrexed disodium|
16370019|NCT00096174|Biological|cetuximab C225|400 mg/m^2 IV over 120 minutes on Day 1, 250 mg/m^2 IV over 60 minutes on Day 8, then weekly
16370020|NCT00096174|Drug|cisplatin|75 mg/m^2 IV over 30-60 minutes starting day 15 every 3 weeks * 3 (Days 1, 22, and 43 of radiation therapy (RT))
16370021|NCT00096174|Radiation|radiation therapy|RT 70 Gy / 35 starting Day 15, 200cGy / d * 7 weeks (35 fractions)
16370022|NCT00096161|Drug|Cyclosporine|Given PO
16370023|NCT00096161|Drug|Mycophenolate Mofetil|Given PO
16370024|NCT00096161|Drug|Pentostatin|Given IV
16370025|NCT00096161|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
16370026|NCT00096148|Drug|idarubicin|Given IV
16370027|NCT00096148|Drug|cytarabine|Given IV
16370028|NCT00096148|Biological|bevacizumab|Given IV
16370029|NCT00096148|Other|laboratory biomarker analysis|Correlative studies
16370030|NCT00096135|Biological|filgrastim|given subcutaneously (SC)
16370031|NCT00096135|Drug|cyclophosphamide|IV over 15-30 minutes
16370032|NCT00096135|Drug|cytarabine|IV over 3 hours twice daily
16370033|NCT00096135|Drug|daunorubicin hydrochloride|IV over 15 minutes
16370034|NCT00096135|Drug|dexamethasone|oral twice daily
16370035|NCT00096135|Drug|etoposide|IV over 1 hour
16370036|NCT00096135|Drug|leucovorin calcium|rescue IV over 24 hours
16370037|NCT00096135|Drug|mercaptopurine|oral
16370038|NCT00096135|Drug|methotrexate|intramuscularly (IM)
16370039|NCT00096135|Drug|pegaspargase|intramuscularly (IM)
16370040|NCT00096135|Drug|therapeutic hydrocortisone|
16370041|NCT00096135|Drug|vincristine sulfate|given IV
16370042|NCT00096135|Radiation|radiation therapy|Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
16370043|NCT00096122|Drug|cytarabine|Given IV
16370044|NCT00096122|Drug|idarubicin|Given IV
16370045|NCT00096122|Drug|tipifarnib|Given orally
16370046|NCT00096109|Drug|tanespimycin|Given IV
16370047|NCT00096109|Other|laboratory biomarker analysis|Correlative studies
16370048|NCT00096096|Drug|mycophenolate mofetil|
16370049|NCT00096096|Drug|tacrolimus|
16370050|NCT00096083|Drug|isolated perfusion|
16370051|NCT00096083|Drug|melphalan|
16370052|NCT00096070|Radiation|radiation therapy|Undergo radiation therapy
16370053|NCT00096070|Drug|oxaliplatin|Given IV
16370054|NCT00096070|Drug|fluorouracil|Given IV
16370055|NCT00096070|Drug|gemcitabine hydrochloride|Given IV
16370056|NCT00096057|Biological|monoclonal antibody HuHMFG1|
16370057|NCT00096044|Biological|rituximab|IV
16370058|NCT00096044|Drug|lenalidomide|Oral
16370059|NCT00096031|Biological|cetuximab|1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
16370060|NCT00096018|Drug|fludarabine phosphate|Given IV
16370061|NCT00096018|Drug|thalidomide|Orally
16370062|NCT00096005|Drug|tanespimycin|Given IV
16370063|NCT00096005|Drug|bortezomib|Given IV
16370064|NCT00096005|Other|laboratory biomarker analysis|Correlative studies
16370065|NCT00095992|Drug|ispinesib|SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks
16370066|NCT00095979|Drug|ixabepilone|Given IV
16370067|NCT00095966|Drug|sorafenib tosylate|Given orally
16370068|NCT00095966|Drug|gemcitabine hydrochloride|Given IV
16370069|NCT00095953|Drug|ispinesib|SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
16370070|NCT00095940|Drug|lapatinib ditosylate|Given orally
16370071|NCT00095940|Procedure|therapeutic conventional surgery|Undergo surgery
16370072|NCT00095940|Other|laboratory biomarker analysis|Correlative studies
16370073|NCT00095940|Other|pharmacological study|Correlative studies
16370074|NCT00095940|Procedure|positron emission tomography|Correlative studies
16370075|NCT00095940|Procedure|magnetic resonance imaging|Correlative studies
16370076|NCT00095927|Drug|Amifostine|Given subcutaneously
16370077|NCT00095927|Drug|Carboplatin|Given IV
16370078|NCT00095927|Drug|Paclitaxel|Given IV
16370079|NCT00095927|Radiation|radiation|Given once daily for 4 weeks and then twice daily for 2 weeks.
16370080|NCT00095914|Drug|paclitaxel|
16370081|NCT00095914|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16370082|NCT00095901|Drug|Capecitabine|
16370083|NCT00095888|Drug|triapine|Given IV
16370084|NCT00095888|Drug|gemcitabine hydrochloride|Given IV
16370085|NCT00095888|Other|laboratory biomarker analysis|Correlative studies
16370086|NCT00095888|Other|pharmacological study|Correlative studies
16370087|NCT00095875|Drug|carboplatin|Given IV
16370088|NCT00095875|Drug|cisplatin|Given IV
16370089|NCT00095875|Drug|docetaxel|Given IV
16370090|NCT00095875|Drug|fluorouracil|Given IV
16370091|NCT00095862|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|
16370092|NCT00095862|Biological|recombinant interferon alfa|
16370093|NCT00095862|Drug|cyclophosphamide|
16370094|NCT00095836|Drug|Gefitinib|Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
16370095|NCT00095823|Drug|Antidepressant + Placebo|Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
16370096|NCT00095823|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
16370097|NCT00095810|Drug|aripiprazole|Tablets, Oral, 1-10mg, Once daily, 6 weeks.
16370098|NCT00095797|Drug|R(+)XK469|Given IV
16370099|NCT00095797|Other|pharmacological study|Correlative studies
16370100|NCT00095797|Other|laboratory biomarker analysis|Optional correlative studies
16370101|NCT00095784|Drug|Decitabine|Given SC
16370102|NCT00095784|Other|Laboratory Biomarker Analysis|Correlative studies
16370103|NCT00095771|Drug|arsenic trioxide|
16370104|NCT00095771|Radiation|radiation therapy|
16370105|NCT00095758|Drug|Antidepressant + Placebo|Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
16370106|NCT00095758|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
16370107|NCT00095745|Drug|Antidepressant + Aripiprazole|Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
16370108|NCT00095732|Drug|Liprotamase|Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
16370109|NCT00095732|Drug|Placebo|Administered orally in either Size 2 or Size 5 capsules
16370110|NCT00095719|Drug|Aripiprazole|IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.
16370111|NCT00095719|Drug|Placebo|IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.
16370112|NCT00095706|Drug|Bevacizumab (drug), Herceptin (drug)|
16370113|NCT00095693|Drug|sorafenib tosylate|Given PO
16370114|NCT00095693|Other|laboratory biomarker analysis|Correlative studies
16370115|NCT00095693|Other|pharmacological study|Correlative studies
16370116|NCT00095693|Radiation|fludeoxyglucose F 18|Correlative studies
16370117|NCT00095693|Procedure|positron emission tomography|Correlative studies
16370118|NCT00095693|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Correlative studies
16370119|NCT00095680|Drug|SCIO-469|two 30-mg capsules three times daily
16370120|NCT00095680|Drug|SCIO-469 and bortezomib|The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
16370121|NCT00095667|Drug|lapatinib ditosylate|Given orally
16370122|NCT00095667|Other|laboratory biomarker analysis|Correlative studies
16370123|NCT00095654|Drug|Ramipril|
16370124|NCT00095654|Drug|Rosiglitazone|
16370125|NCT00095641|Drug|capecitabine|
16370126|NCT00095641|Procedure|adjuvant therapy|
16370127|NCT00095641|Procedure|chemotherapy|
16370128|NCT00095628|Drug|ispinesib|Given IV
16370129|NCT00095628|Other|laboratory biomarker analysis|Correlative studies
16370130|NCT00095628|Other|pharmacological study|Correlative studies
16370131|NCT00095589|Genetic|loss of heterozygosity analysis|
16370132|NCT00095589|Genetic|microarray analysis|
16370133|NCT00095589|Genetic|microsatellite instability analysis|
16370134|NCT00095589|Other|cytology specimen collection procedure|
16370135|NCT00095589|Other|laboratory biomarker analysis|
16370136|NCT00095589|Procedure|computed tomography|
16370137|NCT00095589|Procedure|cystoscopy|
16370138|NCT00095576|Biological|Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)|"Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose).
~This dose is equivalent to 3x10^10 vp/dose used in study V520-016."
16370139|NCT00095576|Drug|Comparator: placebo|Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
16370140|NCT00095563|Drug|lapatinib ditosylate|Given orally
16370141|NCT00095563|Other|laboratory biomarker analysis|Correlative studies
16370142|NCT00095550|Drug|Irbesartan/HCTZ|Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
16370143|NCT00095550|Drug|Irbesartan monotherapy|Tablets, Oral, 150 mg, Once daily, 12 weeks.
16370144|NCT00095550|Drug|HCTZ monotherapy|Tablets, Oral, 12.5 mg, Once daily, 12 weeks.
16370145|NCT00095537|Drug|panHer|Tablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.
16370146|NCT00095524|Drug|Aripiprazole|
16370147|NCT00095511|Drug|aripiprazole|
16370150|NCT00095472|Drug|L-NMMA|
16370151|NCT00095472|Drug|Sodium Nitrite|
16370152|NCT00095459|Drug|Bevacizumab|
16370153|NCT00095459|Drug|BAY 43-9006|
16370154|NCT00095446|Drug|insulin aspart|
16370155|NCT00095433|Drug|rhuFab V2 (ranibizumab)|
16370156|NCT00095420|Behavioral|Social skills training targeting children with autism|Sessions will focus on improving the social skills of autistic children. Thirty-minute sessions will be held twice a week for 6 weeks.
16370157|NCT00095420|Behavioral|Social skills training of peers without autism|Sessions will involve educating the peers of autistic children to increase their acceptance of their autistic peers. Thirty-minute sessions will be held twice a week for 6 weeks.
16370158|NCT00095420|Behavioral|Combination treatment of social skills/education about autism|The combination treatment includes children with and without autism. Sessions will involve social skills training and education about autism to increase acceptance of autistic peers. Training will be conducted twice a week for 6 weeks
16370159|NCT00095420|Behavioral|Usual training|Participants will receive the usual training offered in their local school districts.
16370160|NCT00095394|Drug|Irbesartan/HCTZ|Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
16370161|NCT00095394|Drug|Irbesartan monotherapy|Tablets, Oral, 150 mg, Once daily, 7 weeks.
16370162|NCT00095381|Drug|forodesine hydrochloride (BCX-1777)|
16370163|NCT00095368|Drug|Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)|
16370164|NCT00095355|Drug|Lithium|
16370165|NCT00095355|Drug|Divalproex|
16370166|NCT00095342|Drug|TMI-005|
16370167|NCT00095329|Biological|sirolimus|
16370168|NCT00095316|Drug|Caspofungin|Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.
16370169|NCT00095316|Other|Placebo|Normal saline equivalent to that used to deliver the caspofungin given intravenously as a single daily dose infused over approximately 1 hour for 28 days
16370170|NCT00095303|Behavioral|Brief Strategic Family Therapy (BSFT)|"BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
16370171|NCT00095303|Behavioral|Treatment as Usual|TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
16370172|NCT00095290|Drug|Ramipril + Irbesartan|Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks.
16370173|NCT00095290|Drug|Ramipril + Placebo|Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks.
16370174|NCT00095277|Drug|Darbepoetin Alfa|
16370175|NCT00095264|Drug|Darbepoetin Alfa|
16370176|NCT00095251|Drug|Dexmedetomidine|a bolus dose of 1 μg/kg infused over 10 minutes followed by an infusion started at 0.15- 0.45 μg/kg/hr. Dexmedetomidine will be titrated every 10 minutes to achieve set target RASS score. The maximum dexmedetomidine infusion will be 1.5 μg/kg/hr.
16370177|NCT00095251|Drug|Lorazepam|Patients in the lorazepam arm will receive a bolus dose of 1-3 mg followed by an infusion started at 1-3 mg/hr. Lorazepam infusion will be titrated every 10 minutes to achieve set target RASS score. The maximum lorazepam infusion will be 10 mg /hr.
16370178|NCT00095238|Drug|Irbesartan|Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
16370179|NCT00095238|Drug|Placebo|Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
16370180|NCT00095225|Drug|Avastin (bevacizumab)|
16370181|NCT00095225|Drug|Tarceva (erlotinib HCl)|
16370182|NCT00095212|Drug|1 Transdermal Testosterone (Patch)|300 micrograms twice a week
16370183|NCT00095212|Drug|2 Placebo Patch|Placebo patch (0 micrograms of testosterone) applied twice a week
16370184|NCT00095199|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
16370185|NCT00095199|Biological|Cetuximab|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.
16370186|NCT00095199|Drug|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
16370187|NCT00095186|Drug|Recombinant Human Lactoferrin|
16370188|NCT00095173|Drug|Abatacept|IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
16370189|NCT00095173|Drug|Placebo|IV infusions, IV, N/A, every 4 weeks, 6 months.
16370190|NCT00095173|Drug|Abatacept|Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly
16370191|NCT00095160|Drug|852A|
16370192|NCT00095147|Drug|Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)|Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
16370193|NCT00095147|Drug|Infliximab (INF) + MTX, DB|Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
16370194|NCT00095147|Drug|Placebo (PLA) + MTX, DB|Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
16370195|NCT00095147|Drug|PLA + MTX switched to ABA+ MTX, DB|Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
16370196|NCT00095147|Drug|ABA, open-label (OL)|Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
16370197|NCT00095134|Drug|risperidone|
16370198|NCT00095121|Drug|Placebo (PLB)|Matching placebo
16370199|NCT00095121|Drug|Adefovir Dipivoxil (ADV)|10-mg tablet or 2-mg/mL oral suspension
16370200|NCT00095121|Drug|Lamivudine|100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained >= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.
16370201|NCT00095108|Drug|Recombinant Human Interleukin-21|
16370202|NCT00095095|Device|Lumbar Interbody Fusion|
16370203|NCT00095082|Drug|insulin detemir|
16370204|NCT00095082|Drug|insulin glargine|
16370205|NCT00095082|Drug|insulin aspart|
16370206|NCT00095069|Drug|MK0928, gaboxadol / Duration of Treatment - 1 year|
16370207|NCT00095069|Drug|Comparator: placebo / Duration of Treatment -1 year|
16370208|NCT00095056|Drug|sitagliptin|One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.
16370209|NCT00095056|Drug|Placebo to Sitagliptin|One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.
16370210|NCT00095056|Drug|glipizide|One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
16370211|NCT00095056|Drug|Placebo to glipizide|One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
16370212|NCT00095043|Drug|MK0928, gaboxadol|
16370213|NCT00095043|Drug|Comparator: placebo|
16370214|NCT00095030|Drug|muraglitazar|
16370215|NCT00095017|Drug|MK0663, etoricoxib / Duration of Treatment: 4 weeks|
16370216|NCT00095004|Drug|MK0462, rizatriptan benzoate / Duration of Treatment: 1day|
16370217|NCT00095004|Drug|Comparator: placebo / Duration of Treatment: 1 day|
16370218|NCT00094991|Drug|Muraglitazar|
16370219|NCT00094978|Drug|Depsipeptide|
16370220|NCT00094978|Drug|Flavopiridol (alvocidib)|
16370221|NCT00094965|Drug|Oxaliplatin (SR96669)|oxaliplatin in combination with FOLFOX4
16370222|NCT00094926|Drug|Risperdal Consta|25, 37.5 or 50mg IM injections every 2wks for 52wks
16370223|NCT00094926|Drug|placebo|matching placebo IM injections every 2wks for 52wks
16370224|NCT00094900|Drug|IL-1 Trap|
16370225|NCT00094887|Drug|Nitric Oxide|Nitric oxide will be delivered for 4 hours at 80 ppm through a face mask. The dose will then be reduced to 40 ppm for 4 hours. After a total of 8 hours of treatment through face mask, the patient will get 6 mL/puls/breath of NO at 800 ppm or 3 m//pulse/breath, depending on patient weight.
16370226|NCT00094887|Drug|Placebo|Nitrogen gas will be delivered in the same manor as the experimental drug.
16370227|NCT00094874|Procedure|Acupuncture|
16370228|NCT00094861|Drug|Palifermin|
16370229|NCT00094861|Drug|Placebo|
16370230|NCT00094861|Radiation|Radiotherapy|
16370231|NCT00094861|Drug|Paclitaxel|
16370232|NCT00094861|Drug|Carboplatin|
16370233|NCT00094848|Drug|TRAIL-R1 mAb (TRM-1; HGS-ETR1)|
16370234|NCT00094835|Biological|Panitumumab|9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes.
16370235|NCT00094835|Drug|Motesanib diphosphate|Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested.
16370236|NCT00094835|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 administered by IV infusion over 3 hours.
16370503|NCT00092963|Drug|MK0462, rizatriptan benzoate / Duration of Treatment: 1day|
16370237|NCT00094835|Drug|Carboplatin|Carboplatin was administered IV over approximately 30 minutes. Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to AUC/time curve of 6 mg/mL×min.
16370238|NCT00094822|Other|PI Discretion|PI Discretion
16370239|NCT00094809|Drug|Placebo|Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
16370240|NCT00094809|Drug|Pegfilgrastim|Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
16370241|NCT00094796|Procedure|Exercise cardiopulmonary metabolic testing|
16370242|NCT00094796|Procedure|Skeletal muscle biopsy|
16370243|NCT00094796|Procedure|Brachial artery reactivity testing|
16370244|NCT00094783|Procedure|MRI|
16370245|NCT00094770|Drug|sitagliptin (MK0431)|Sitagliptin 100 mg oral tablets of sitagliptin once daily.
16370246|NCT00094770|Drug|Comparator: glipizide|Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
16370247|NCT00094757|Drug|Comparator: sitagliptin 100 mg|sitagliptin 100 mg oral tablet once daily for 54 weeks
16370248|NCT00094757|Drug|Comparator: sitagliptin 200 mg|sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
16370249|NCT00094757|Drug|Comparator: placebo|placebo oral tablet once daily during Phase A (Weeks 0-18)
16370250|NCT00094757|Drug|Comparator: pioglitazone|pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
16370251|NCT00094744|Device|Eye patch|adhesive eye patch used to cover the sound eye
16370252|NCT00094731|Procedure|Memory Training|
16370253|NCT00094718|Biological|WN/DEN4-3'delta30|Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)
16370254|NCT00094718|Biological|Placebo|Placebo for WN/DEN4-3'delta30 vaccine
16370255|NCT00094705|Biological|rDEN2/4delta30(ME) Vaccine|Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
16370256|NCT00094705|Biological|Placebo|Placebo for rDEN2/4delta30(ME) vaccine
16370257|NCT00094692|Device|Eye patch|
16370258|NCT00094692|Device|spectacles|
16370259|NCT00094692|Drug|atropine|
16370260|NCT00094679|Device|Eye patch|adhesive patch to cover the sound eye
16370261|NCT00094666|Drug|MK0928, gaboxadol / Duration of Treatment - 6 weeks|
16370262|NCT00094666|Drug|Comparator: placebo / Duration of Treatment - 6 weeks|
16370263|NCT00094653|Drug|MDX-010 (anti-CTLA4) monoclonal antibody|3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
16370264|NCT00094653|Biological|MDX-1379 (gp100) Melanoma Peptide Vaccine|2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
16370265|NCT00094640|Drug|Intramuscular Olanzapine Depot|
16370266|NCT00094627|Drug|gaboxadol|Duration of Treatment - 6 weeks
16370267|NCT00094627|Drug|Comparator: placebo (unspecified)|Duration of Treatment - 6 weeks
16370268|NCT00094614|Drug|Atropine|
16370269|NCT00094575|Procedure|Endovascular Repair|Endovascular Repair
16370270|NCT00094575|Procedure|Standard Open Repair|Standard Open Repair
16370271|NCT00094562|Drug|Fish oil supplement|
16370272|NCT00094549|Drug|olanzapine|
16370273|NCT00094549|Drug|divalproex sodium|
16370274|NCT00094549|Drug|placebo|
16370275|NCT00094536|Device|Extended treatment regimen using Her Option Cryotherapy|Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
16370276|NCT00094523|Drug|Fosamprenavir|Fosamprenavir
16370277|NCT00094497|Drug|Etoposide|
16370278|NCT00094497|Drug|Doxorubicin|
16370279|NCT00094497|Drug|Cisplatin|
16370280|NCT00094497|Drug|Streptozotocin|
16370281|NCT00094497|Drug|Mitotane|
16370282|NCT00094484|Drug|Cinacalcet HCl|
16370283|NCT00094458|Biological|infliximab infusion; AZA placebo caps|Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
16370284|NCT00094458|Other|infliximab (IFX) infusion; azathioprine (AZA) caps|AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22
16370285|NCT00094458|Drug|infliximab (IFX) placebo infusion; azathioprine (AZA) caps|AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
16370286|NCT00094445|Drug|Curcumin|Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
16370287|NCT00094432|Drug|Aripiprazole|Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
16370288|NCT00094432|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
16370289|NCT00094406|Procedure|Bronchoscopy|
16370290|NCT00094406|Procedure|Bronchoalveolar lavage|
16370291|NCT00094406|Drug|Endotoxin|
16370292|NCT00094406|Drug|Carbon Monoxide|
16370293|NCT00094380|Drug|CTLA4-IgG4m (RG2077)|
16370294|NCT00094380|Drug|Cyclophosphamide|
16370295|NCT00094367|Drug|Abacavir/Lamivudine|
16370296|NCT00094341|Drug|Etanercept|
16370297|NCT00094328|Drug|Bicalutamide|oral
16370298|NCT00094328|Drug|Anastrozole|oral
16370299|NCT00094315|Drug|Cocaine (IV)|
16370300|NCT00094302|Drug|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
16370301|NCT00094302|Drug|Placebo|Placebo of spironolactone
16370302|NCT00094289|Drug|Disulfiram|
16373634|NCT00003160|Drug|paclitaxel|
16370303|NCT00094276|Behavioral|Facilitated Asthma Communication Intervention (FACI)|A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
16370304|NCT00094276|Behavioral|Breathmobile intervention|A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
16370305|NCT00094250|Behavioral|Resistance and Aerobic Training|
16370306|NCT00094172|Drug|Atorvastatin|atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated
16370307|NCT00094172|Drug|Placebo|tablet form
16370308|NCT00094159|Drug|SNS-595|
16370309|NCT00094146|Drug|Sandostatin LAR Depot|
16370310|NCT00094133|Procedure|hot flashes attenuation|
16370311|NCT00094133|Procedure|hypnotherapy|
16370312|NCT00094120|Drug|MSI-1256F (Squalamine Lactate)|
16370313|NCT00094107|Drug|Axitinib [AG-013736]|VEGFR [vascular endothelial growth factor Receptor] and PDGFR [Platelet-Derived Growth Factor Receptor] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.
16370314|NCT00094094|Drug|axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.
16370315|NCT00094081|Drug|tirapazamine (SR259075)|
16370316|NCT00094081|Drug|cisplatin|
16370317|NCT00094081|Procedure|Radiation Therapy|
16370318|NCT00091468|Drug|Transdermal nicotine patch|double-blind phase: 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks open label phase: 5mg for 1 week, 10mg. for 2 weeks, 15mg. for 23 weeks taper down: 10mg. for 2 weeks, 5mg. for 1 week
16370319|NCT00091468|Drug|Placebo transdermal patch|placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
16370320|NCT00081627|Drug|CoFactor and 5FU|
16370321|NCT00094055|Drug|AG013736|AG013736, tablets 5 mg BID daily until tumor progression or toxicity
16370322|NCT00094042|Drug|Iron Supplement, 120mg|
16370323|NCT00094029|Drug|Sutent|Sutent, 25, 37.5, or 50 mg daily
16370324|NCT00094016|Drug|beclomethasone dipropionate|
16370325|NCT00094003|Drug|NS-9 [Poly I: Poly C]|
16370326|NCT00093990|Drug|Tipifarnib;Zarnestra; R115777|
16370327|NCT00093977|Drug|darbepoetin alfa SF|"Frequency of dosing depends on frequency at randomization:
~rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL"
16370328|NCT00093964|Drug|Cilengitide 500 mg|Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
16370329|NCT00093964|Drug|Cilengitide 2000 mg|Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
16370330|NCT00093951|Drug|SGS742|
16370331|NCT00093938|Drug|Cranberry juice|
16370332|NCT00093925|Drug|clevidipine|
16370333|NCT00093925|Drug|nicardipine|
16370334|NCT00093912|Drug|clevidipine|
16370335|NCT00093912|Drug|sodium nitroprusside|
16370336|NCT00093899|Drug|ezetimibe (+) simvastatin|Duration of Treatment: 6 months
16370337|NCT00093886|Drug|clevidipine|
16370338|NCT00093886|Drug|nitroglycerin|
16370339|NCT00093873|Drug|Anti-angiogenesis|Anti-angiogenesis
16370340|NCT00093873|Drug|AMG 706|Anti-angiogenesis
16370341|NCT00093847|Drug|S-adenosyl methione (SAMe)|Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
16370342|NCT00093847|Drug|Placebo|Placebo to be taken daily for 6 weeks
16370343|NCT00093834|Biological|allogeneic GM-CSF-secreting breast cancer vaccine|The first three patients will receive a dose of 5 X 107 cells, and the next three will receive a dose of 5 X 108 cells. Then, if these two doses of vaccine alone are found to be safe, a fixed vaccine dose of 5 X 108 cells will be tested in combination with chemotherapy based on the safety of the allogeneic breast vaccine alone and the safety and bioactivity of a dose of 5 X 108 cells in the allogeneic pancreatic vaccine trial
16370344|NCT00093834|Drug|cyclophosphamide|This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination
16370345|NCT00093834|Drug|doxorubicin hydrochloride|This trial will be a dose ranging study of a fixed sequence of drug doses in a three by three factorial matrix modeled after the theories of Plackett and Burman (Plackett et al., 1946), and is designed to determine the doses of CY and DOX that maximize the immunologic response to vaccination
16370346|NCT00093821|Drug|tanespimycin|Given IV
16370347|NCT00093821|Other|pharmacological study|Correlative studies
16370348|NCT00093821|Other|laboratory biomarker analysis|Correlative studies
16370349|NCT00093808|Biological|trastuzumab|
16370350|NCT00093808|Drug|capecitabine|
16370351|NCT00093808|Drug|vinorelbine tartrate|
16370352|NCT00093795|Drug|Cyclophosphamide|"Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles"
16370353|NCT00093795|Drug|Docetaxel|75 mg/m2 IV every 21 days for 6 cycles
16370354|NCT00093795|Drug|Gemcitabine|2000 mg/m2 IV every 14 days for 4 cycles
16370355|NCT00093795|Drug|Paclitaxel|175 mg/m2 IV every 14 days for 4 cycles
16370356|NCT00093795|Drug|Doxorubicin|"Group 1: 50 mg/m2 IV every 21 days for 6 cycles
~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
16370357|NCT00093782|Drug|temsirolimus|Given IV
16370358|NCT00093782|Other|laboratory biomarker analysis|Correlative studies
16370504|NCT00092963|Drug|Comparator: placebo / Duration of Treatment: 1 day|
16370505|NCT00092924|Drug|TRAIL-R1 mAb (TRM-1;HGS-ETR1)|
16370359|NCT00093769|Drug|bortezomib + rituximab|"Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
~Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
~Patients in either arm may crossover to the other arm if treatment is found to be ineffective."
16370360|NCT00093756|Radiation|3-dimensional conformal radiation therapy|
16370361|NCT00093756|Drug|bortezomib|Given IV
16370362|NCT00093756|Drug|paclitaxel|Given IV
16370363|NCT00093756|Drug|carboplatin|Given IV
16370364|NCT00093743|Drug|fludarabine phosphate|Given IV
16370365|NCT00093743|Drug|cyclosporine|Given IV or PO
16370366|NCT00093743|Radiation|total-body irradiation|Undergo TBI
16370367|NCT00093743|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplantation
16370368|NCT00093743|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplantation
16370369|NCT00093743|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplantation
16370370|NCT00093743|Drug|mycophenolate mofetil|Given PO or IV
16370371|NCT00093730|Drug|BMS-59926|
16370372|NCT00093704|Drug|bortezomib + ganciclovir|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
16370373|NCT00093678|Drug|celecoxib|
16370374|NCT00093678|Procedure|anticachectic therapy|
16370375|NCT00093678|Procedure|nutritional support|
16370376|NCT00093678|Procedure|pain therapy|
16370377|NCT00093678|Procedure|supportive care/therapy|
16370378|NCT00093665|Drug|cisplatin|
16370379|NCT00093665|Drug|fluorouracil|
16370380|NCT00093665|Radiation|radiation therapy|
16370381|NCT00093652|Drug|gefitinib|
16370382|NCT00093652|Drug|oxaliplatin|
16370383|NCT00093652|Procedure|conventional surgery|
16370384|NCT00093652|Procedure|neoadjuvant therapy|
16370385|NCT00093652|Radiation|radiation therapy|
16370386|NCT00093639|Drug|everolimus|
16370387|NCT00093639|Drug|imatinib mesylate|
16370388|NCT00093626|Other|Laboratory Biomarker Analysis|Correlative studies
16370389|NCT00093626|Drug|Sorafenib Tosylate|Given orally
16370390|NCT00093613|Drug|sorafenib tosylate|Given PO
16370391|NCT00093613|Other|pharmacological study|Correlative studies
16370392|NCT00093600|Drug|cytarabine|
16370393|NCT00093600|Drug|daunorubicin hydrochloride|
16370394|NCT00093600|Drug|midostaurin|
16370395|NCT00093587|Biological|anti-thymocyte globulin|
16370396|NCT00093587|Drug|busulfan|
16370397|NCT00093587|Drug|cyclophosphamide|
16370398|NCT00093587|Drug|cyclosporine|
16370399|NCT00093587|Procedure|allogeneic bone marrow transplantation|
16370400|NCT00093587|Procedure|peripheral blood stem cell transplantation|
16370401|NCT00093587|Radiation|radiation therapy|
16370402|NCT00093561|Dietary Supplement|lycopene|
16370403|NCT00093548|Biological|alpha fetoprotein adenoviral vector vaccine|
16370404|NCT00093548|Biological|alpha fetoprotein plasmid DNA vaccine|
16370405|NCT00093548|Biological|sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant|
16370406|NCT00093522|Biological|autologous tumor cell vaccine|
16370407|NCT00093522|Biological|keyhole limpet hemocyanin|
16370408|NCT00093522|Biological|therapeutic autologous dendritic cells|
16370409|NCT00093522|Drug|fludarabine phosphate|
16370410|NCT00093522|Procedure|conventional surgery|
16370411|NCT00093509|Drug|doxorubicin hydrochloride|To be dosed at 75 mg/m2 i.v. push every 4 weeks for 4 cycles. This treatment is optional and will not be used on all subjects.
16370412|NCT00093509|Drug|ifosfamide and mesna|2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.
16370413|NCT00093509|Procedure|hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator|Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.
16370414|NCT00093509|Radiation|radiation therapy|External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of > 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.
16370415|NCT00093496|Drug|gemcitabine hydrochloride|Given IV
16370416|NCT00093496|Drug|tanespimycin|Given IV
16370417|NCT00093483|Biological|filgrastim|Subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover.
16370418|NCT00093483|Drug|arsenic trioxide|IV over 1 hour on day 1
16370419|NCT00093483|Drug|cytarabine|IV over 1 hour every 12 hours on days 1-6
16370420|NCT00093483|Drug|idarubicin|IV over 30 minutes on days 2-4 (immediately after doses 3, 5 and 7 of cytarabine).
16370421|NCT00093470|Procedure|Clinical Observation|Undergo observation
16370422|NCT00093470|Drug|Tipifarnib|Given PO
16370423|NCT00093457|Drug|sorafenib tosylate|BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
16370424|NCT00093444|Drug|lyso-thermosensitive liposomal doxorubicin|
16370425|NCT00093444|Procedure|radiofrequency ablation|
16370426|NCT00093418|Drug|tipifarnib|Given orally
16370427|NCT00093405|Drug|tanespimycin|
16370428|NCT00093379|Drug|Capecitabine|825 mg/m^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
16370429|NCT00093379|Drug|Oxaliplatin|50 mg/m^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
16370506|NCT00092911|Drug|DVS-233 SR|
16370430|NCT00093379|Radiation|Radiation Therapy (XRT)|Undergo radiotherapy* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. *Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.
16370431|NCT00093366|Biological|etanercept|
16370432|NCT00093366|Drug|arsenic trioxide|
16370433|NCT00093353|Drug|cefixime|
16370434|NCT00093353|Drug|irinotecan hydrochloride|
16370435|NCT00093353|Drug|temozolomide|
16370436|NCT00093327|Procedure|Acupuncture|
16370437|NCT00093314|Drug|HuMax-CD20|
16370438|NCT00093860|Drug|Propranolol|
16370439|NCT00093301|Drug|Levosimendan|
16370440|NCT00093301|Drug|Dobutamine|
16370441|NCT00093288|Drug|bupropion XL|
16370442|NCT00093275|Drug|HP184|
16370443|NCT00093262|Drug|clevidipine|
16370444|NCT00093262|Drug|placebo|
16370445|NCT00093249|Drug|clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
16370446|NCT00093249|Drug|placebo|Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.
16370447|NCT00093236|Procedure|Early Periodontal Treatment|Subjects will receive scaling and root planing at baseline. Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health.comprehensive periodontal treatment
16370448|NCT00093236|Procedure|Usual Dental Hygiene|Subjects will receive routine oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.
16370449|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).
16370450|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|
16370451|NCT00093223|Drug|Paclitaxel Nanoparticle Albumin Bound|35mg/35 infusion time is 3.5 minutes
16370452|NCT00093210|Drug|rFIX|
16370453|NCT00093210|Drug|rFIX-R|
16370454|NCT00093197|Drug|KAI-9803 for Injection|0.05 mg
16370455|NCT00093197|Drug|KAI-9803 for Injection|0.5 mg
16370456|NCT00093197|Drug|KAI-9803 for Injection|1.25 mg
16370457|NCT00093197|Drug|KAI-9803 for Injection|5 mg
16370458|NCT00093197|Drug|Placebo|
16370459|NCT00093184|Drug|Angiomax (bivalirudin) anticoagulant|
16370460|NCT00093171|Drug|rFIX|
16370461|NCT00093158|Drug|Angiomax (bivalirudin) anticoagulant|
16370462|NCT00093145|Drug|Albumin-bound paclitaxel|Administered by intravenous infusion.
16370463|NCT00093145|Drug|Carboplatin|Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
16370464|NCT00093145|Drug|Herceptin®|Administered by IV infusion
16370465|NCT00002543|Drug|gallium nitrate|
16370466|NCT00002524|Biological|Bleomycin Sulfate|
16370467|NCT00002524|Biological|Filgrastim|
16370468|NCT00002524|Drug|Cisplatin|
16370469|NCT00002524|Drug|Cyclophosphamide|
16370470|NCT00002524|Drug|Cytarabine|
16370471|NCT00002524|Drug|Doxorubicin Hydrochloride (DOX)|
16370472|NCT00002524|Drug|Etoposide|
16370473|NCT00002524|Drug|Fluorouracil|
16370474|NCT00002524|Drug|Ifosfamide|
16370475|NCT00002524|Drug|Leucovorin calcium|
16370476|NCT00002524|Drug|Methotrexate|
16370477|NCT00002524|Drug|Methylprednisolone|
16370478|NCT00002524|Drug|Pentamidine|
16370479|NCT00002524|Drug|Prednisone|
16370480|NCT00002524|Drug|Trimethoprim-Sulfamethoxazole|
16370481|NCT00002524|Drug|Vincristine Sulfate|
16370482|NCT00002524|Drug|Zidovudine (AZT)|
16370483|NCT00002524|Radiation|Radiation Therapy|
16370484|NCT00093132|Drug|Satraplatin|Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
16370485|NCT00093119|Drug|ABI-007|
16370486|NCT00093093|Drug|Viramidine|
16370487|NCT00093093|Drug|Ribavirin|
16370488|NCT00093093|Drug|pegylated interferon alfa-2a|
16370489|NCT00093080|Drug|ridaforolimus|12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
16370490|NCT00093067|Drug|daptomycin|
16370491|NCT00093054|Drug|Cranberry juice|TID dosage for UTI treatment
16370492|NCT00093054|Dietary Supplement|Placebo cranberry juice|TID placebo dosage to match active comparator
16370493|NCT00093041|Drug|Zalutumumab|Weekly infusion
16370494|NCT00093028|Drug|CC-5013 (Revlimid™)|N/A Study Complete
16370495|NCT00093028|Drug|bortezomib|N/A Study Complete
16370496|NCT00091520|Drug|Nesiritide|
16370497|NCT00093015|Drug|Placebo|Volume and dose frequency changes resembling dosing in the active treatment group
16370498|NCT00093015|Drug|darbepoetin alfa|Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL
16370499|NCT00093002|Drug|Fulvestrant|250 mg & 500 mg intramuscular injection
16370500|NCT00092989|Drug|montelukast sodium|Duration of Treatment: 1 dose
16370501|NCT00092989|Drug|placebo|Duration of Treatment: 1 dose
16370502|NCT00092976|Drug|ReFacto|
16370507|NCT00092898|Drug|MK0653, ezetimibe|
16370508|NCT00092898|Drug|Comparator: placebo|
16370509|NCT00092885|Drug|MK0476, montelukast sodium|
16370510|NCT00092885|Drug|Comparator: placebo|
16370511|NCT00092872|Drug|MK0557|
16370512|NCT00092859|Drug|MK0557|
16370513|NCT00092846|Drug|MK0803, lovastatin|
16370514|NCT00092846|Behavioral|Self-Management System|
16370515|NCT00092833|Drug|Comparator: ezetimibe|Ezetimibe (MK0653) 10 mg once daily for 3 years.
16370516|NCT00092820|Drug|MK0653, ezetimibe|
16370517|NCT00092820|Drug|Comparator: placebo|
16370518|NCT00092807|Drug|MK0653, ezetimibe|
16370519|NCT00092807|Drug|Comparator: placebo|
16370520|NCT00092781|Drug|MK0663, etoricoxib|
16370521|NCT00092781|Drug|Comparator: celecoxib|
16370522|NCT00092768|Drug|MK0663, etoricoxib|
16370523|NCT00092768|Drug|Comparator: celecoxib|
16370524|NCT00092755|Drug|MK0663, etoricoxib|
16370525|NCT00092755|Drug|Comparators: ibuprofen and placebo|
16370526|NCT00092742|Drug|MK0663, etoricoxib|
16370527|NCT00092742|Drug|Comparator: Diclofenac sodium|
16370528|NCT00092729|Drug|etoricoxib (MK0663)|Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
16370529|NCT00092729|Drug|Comparator: placebo (unspecified)|Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
16370530|NCT00092729|Drug|Comparator: naproxen sodium|Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
16370531|NCT00092716|Drug|MK0653, ezetimibe / Duration of Treatment: 28 weeks|
16370532|NCT00092716|Drug|Comparator: atorvastatin / Duration of Treatment: 28 weeks|
16370533|NCT00092703|Drug|MK0663, etoricoxib|
16370534|NCT00092703|Drug|Comparator: Diclofenac sodium|
16370535|NCT00092690|Drug|MK0653A, ezetimibe (+) simvastatin|
16370536|NCT00092690|Drug|Comparator: atorvastatin|
16370537|NCT00092677|Drug|ezetimibe (+) simvastatin|Duration of Treatment: 4 years
16370538|NCT00092677|Drug|Comparator: Placebo|matching Placebo
16370539|NCT00092664|Drug|MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks|
16370540|NCT00092651|Drug|MK0653A, ezetimibe (+) simvastatin|
16370541|NCT00092651|Drug|Comparators: simvastatin and ezetimibe|
16370542|NCT00092586|Drug|MK0653, ezetimibe|
16370543|NCT00092586|Drug|Comparator: statins|
16370544|NCT00092573|Drug|MK0653, ezetimibe|
16370545|NCT00092573|Drug|Comparator: fenofibrate monotherapy|
16370546|NCT00092560|Drug|MK0653, ezetimibe|
16370547|NCT00092560|Drug|Comparator: fenofibrate monotherapy|
16370548|NCT00092547|Biological|V501|0.5 mL intramuscular injection of V501
16370549|NCT00092547|Biological|Comparator: Placebo|0.5 mL intramuscular injection of placebo
16370550|NCT00092534|Biological|Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine|A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
16370551|NCT00092534|Biological|Matching Placebo|A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
16370552|NCT00092521|Biological|V501|Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
16370553|NCT00092521|Biological|Comparator: Placebo|a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
16370554|NCT00092521|Biological|Human Papillomavirus (HPV) 16 Monovalent|HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
16370555|NCT00092508|Drug|OPC-6535|
16370556|NCT00092508|Drug|Asacol®|
16370557|NCT00092300|Drug|MK0966, rofecoxib|
16370558|NCT00092300|Drug|Comparator: valdecoxib|
16370559|NCT00092950|Behavioral|Physical activity|
16370560|NCT00092937|Drug|Busulfan|
16370561|NCT00092638|Drug|MK0653, ezetimibe|
16370562|NCT00092638|Drug|Comparator: ezetimibe, placebo|
16370563|NCT00092625|Drug|MK0653, ezetimibe|
16370564|NCT00092625|Drug|Comparator: ezetimibe, placebo|
16370565|NCT00092612|Drug|MK0653, ezetimibe|
16370566|NCT00092612|Drug|Comparator: ezetimibe, placebo|
16370567|NCT00092599|Drug|MK0653, ezetimibe|
16370568|NCT00092599|Drug|Comparator: ezetimibe, placebo|
16370569|NCT00092495|Biological|V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine|qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
16370570|NCT00092482|Biological|V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years|
16370571|NCT00092469|Biological|V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine|
16370572|NCT00092456|Biological|rotavirus vaccine, live, oral, pentavalent|Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
16370573|NCT00092456|Biological|Placebo|"Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10
~weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination"
16370574|NCT00092443|Biological|RotaTeq™, rotavirus vaccine, live, oral, pentavalent|Three doses of RotaTeq™ administered 28 to 70 days apart.
16370575|NCT00092443|Biological|Comparator: Placebo matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart.
16370576|NCT00092430|Biological|V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks|
16370577|NCT00092417|Biological|Comparator: Varicella Zoster Virus Vaccine|Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)
16370701|NCT00004209|Drug|vinblastine sulfate|
16370879|NCT00091104|Biological|therapeutic tumor infiltrating lymphocytes|
16370578|NCT00092417|Biological|Comparator: Varicella Zoster Virus Vaccine|Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)
16370579|NCT00092404|Biological|measles, mumps, and rubella virus vaccine live|
16370580|NCT00092404|Biological|Comparator: Measles, Mumps, and Rubella Virus Vaccine Live|
16370581|NCT00092391|Biological|Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live|0.5 mL subcutaneous injection of one of three sub-lots on Day 0
16370582|NCT00092391|Biological|Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)|0.5 mL subcutaneous injection on Day 0
16370583|NCT00092378|Drug|MK0966, rofecoxib|
16370584|NCT00092378|Drug|Comparator: diclofenac sodium, placebo|
16370585|NCT00092365|Drug|MK0966, rofecoxib|
16370586|NCT00092365|Drug|Comparator: celecoxib, placebo|
16370587|NCT00092352|Drug|MK0966, rofecoxib|
16370588|NCT00092352|Drug|Comparator: celecoxib, placebo|
16370589|NCT00092339|Drug|MK0966, rofecoxib|
16370590|NCT00092339|Drug|Comparator: valdecoxib, placebo|
16370591|NCT00092326|Drug|MK0966, rofecoxib|
16370592|NCT00092326|Drug|Comparator: oxycodone with acetaminophen, placebo|
16370593|NCT00092313|Drug|MK0966, rofecoxib|
16370594|NCT00092313|Drug|Comparator: oxycodone and acetaminophen|
16370595|NCT00092287|Drug|lanreotide Autogel (somatostatin analogue)|
16370596|NCT00092287|Drug|Sandostatin long acting release (LAR) Depot (somatostatin analogue)|
16370597|NCT00092274|Drug|HuMax-CD20|
16370598|NCT00092001|Drug|Sunitinib|Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
16370599|NCT00091650|Drug|Olanzapine|
16370600|NCT00091650|Drug|placebo|
16370601|NCT00092209|Drug|MK0954A, hydrochlorothiazide (+) losartan potassium|
16370602|NCT00092209|Drug|Comparator: placebo, losartan, hydrochlorothiazide|
16370603|NCT00092196|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
16370604|NCT00092183|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
16370605|NCT00092183|Drug|Comparator: ondansetron / Duration of Treatment: 3 days|
16370606|NCT00092170|Drug|MK0826, ertapenem sodium|
16370607|NCT00092170|Drug|Comparator: Ticarcillin/Clavulanate|
16370608|NCT00092157|Drug|MK0733, simvastatin|
16370609|NCT00092157|Drug|Comparator: simvastatin|
16370610|NCT00092144|Drug|MK0476, montelukast sodium / Duration of Treatment: 4 weeks|
16370611|NCT00092144|Drug|Comparator: placebo / Duration of Treatment: 4 weeks|
16370612|NCT00092131|Drug|Comparator: Montelukast|Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
16370613|NCT00092131|Drug|Comparator: Placebo|Placebo tablet administered orally as a single witnessed dose before exercise challenge
16370614|NCT00092118|Drug|Montelukast|one 10 mg tablet, taken once daily at bed time for 6 weeks
16370615|NCT00092118|Drug|Comparator: Placebo|one placebo tablet, taken once daily at bed time for 6 weeks
16370616|NCT00092105|Drug|MK0476, montelukast sodium|
16370617|NCT00092105|Drug|Comparator: placebo|
16370618|NCT00092092|Drug|Montelukast chewable tablets|Montelukast sodium 5 mg chewable tablets
16370619|NCT00092092|Drug|Budesonide inhaler|Budesonide 200 mcg inhalation powder
16370620|NCT00092092|Drug|Placebo to montelukast chewable tablets|Placebo chewable tablets
16370621|NCT00092092|Drug|Placebo to budesonide inhaler|Placebo inhalation powder
16370622|NCT00092079|Drug|MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks|
16370623|NCT00092066|Drug|MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks|
16370624|NCT00092053|Drug|Placebo|tablets
16370625|NCT00092053|Drug|ibandronate|50 mg tablets
16370626|NCT00092040|Drug|MK0217, alendronate sodium/Duration of Intervention: 12 mo|
16370627|NCT00092040|Drug|Comparator: risedronate / Duration of Intervention: 12 mo|
16370628|NCT00092027|Drug|MK0217, alendronate sodium/Duration of Treatment: 6 months|
16370629|NCT00092027|Drug|Comparator: placebo / Duration of Treatment: 6 months|
16370630|NCT00092014|Drug|Alendronate|Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
16370631|NCT00092014|Drug|Risedronate 35 mg|Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
16370632|NCT00092014|Dietary Supplement|Elemental Calcium|Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
16370633|NCT00092014|Dietary Supplement|Vitamin D|Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
16370634|NCT00092014|Drug|Risendronate placebo|Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
16370635|NCT00092014|Drug|Alendronate placebo|Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
16370636|NCT00091962|Behavioral|Psychoeducation; Treatment recommendations|Counseling program
16370637|NCT00091962|Drug|Pharmacotherapy|Recommendations to patients' PCP for medication to treat depression
16370638|NCT00091962|Other|Usual Care|Physicians' Usual care
16370653|NCT00091988|Behavioral|Lifestyle & Behavioral Change Program|Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.
16370654|NCT00091988|Behavioral|Structured Education Program|Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.
16370655|NCT00091975|Drug|Zemplar Capsule|
16370656|NCT00091949|Drug|pioglitazone|a thiazolidinedione drug
16370657|NCT00091949|Drug|placebo|an inactive substance
16370658|NCT00091923|Device|Eye patch|
16370659|NCT00091923|Device|Spectacles|
16370660|NCT00091936|Drug|Didanosine|
16370661|NCT00091936|Drug|Efavirenz|
16370662|NCT00091936|Drug|Lamivudine|
16370663|NCT00091936|Drug|Standard TB treatment|
16370664|NCT00091910|Drug|Epoetin alfa|
16370665|NCT00091858|Drug|Darbepoetin Alfa|6.75 mcg/kg Q4W
16370666|NCT00091858|Drug|Placebo|Placebo Q4W
16370667|NCT00091845|Drug|AVI-4020 Injection|
16370668|NCT00091832|Biological|Denosumab|Denosumab administered by subcutaneous injection
16370669|NCT00091832|Drug|IV Bisphosphonates|Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
16370670|NCT00091819|Drug|Telavancin|Telavancin 10 mg/kg/day, IV for up to 14 days.
16370671|NCT00091819|Drug|Vancomycin|Vancomycin 1 Gm IV q 12 hrs for up to 14 days.
16370672|NCT00091806|Drug|panitumumab (ABX-EGF)|6 mg/kg once every 2 weeks
16370673|NCT00091806|Drug|Panitumumab|9 mg/kg once every 3 weeks
16370674|NCT00091793|Drug|AMG 162|60 mg/mL denosumab given day 1, month 6, month 12 and month 18
16370675|NCT00091793|Drug|Placebo|Placebo given at day 1, month 6, month 12 and month 18
16370676|NCT00091897|Drug|Rituximab|
16370677|NCT00091897|Drug|rituximab or placebo|A fixed dose of Rituximab or placebo 1GM on Day 1 and 1GM on day 15 (+/- 2 days)
16370678|NCT00091741|Drug|Etanercept (Enbrel)|
16370679|NCT00091728|Drug|Depo Medroxyprogesterone acetate|
16370680|NCT00091728|Drug|Combined oral contraceptives|
16370681|NCT00091715|Drug|bosentan|65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
16370682|NCT00091715|Drug|placebo|placebo for 6 months followed by an open-label period
16370683|NCT00091702|Biological|Cold-adapted live attenuated influenza vaccine (FluMist)|
16370684|NCT00091702|Biological|Inactivated influenza vaccine (IAIV)|
16370685|NCT00091689|Drug|852A|
16370686|NCT00091676|Biological|FNHLId1|5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
16370687|NCT00091676|Biological|KLH + GM-CSF|5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
16370688|NCT00091663|Drug|Tarceva (erlotinib HCl)|
16370689|NCT00091637|Drug|Pexelizumab|Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once
16370690|NCT00091637|Drug|Placebo infusion|bolus infusion over a 10 minute period once
16370691|NCT00004905|Biological|filgrastim|
16370692|NCT00004905|Biological|recombinant interferon alfa|
16370693|NCT00004905|Drug|cyclophosphamide|
16370694|NCT00004905|Drug|cytarabine|
16370695|NCT00004905|Drug|etoposide|
16370696|NCT00004905|Drug|idarubicin|
16370697|NCT00004905|Procedure|peripheral blood stem cell transplantation|
16370698|NCT00004905|Radiation|radiation therapy|
16370699|NCT00004209|Drug|cisplatin|
16370700|NCT00004209|Drug|mitomycin C|
16370702|NCT00004195|Drug|eniluracil|Will be given to either subject pre-operative and metastatic disease
16370703|NCT00004195|Procedure|conventional colon surgery|Only if the subject is amenable to surgical resections
16370704|NCT00004194|Drug|fludarabine phosphate|
16370705|NCT00004184|Biological|monoclonal antibody 4B5 anti-idiotype vaccine|
16370706|NCT00004184|Biological|sargramostim|
16370707|NCT00004184|Drug|alum adjuvant|
16370708|NCT00004172|Biological|filgrastim|
16370709|NCT00004172|Drug|carboplatin|
16370710|NCT00004172|Drug|cyclophosphamide|
16370711|NCT00004172|Drug|ifosfamide|
16370712|NCT00004172|Drug|thiotepa|
16370713|NCT00004172|Procedure|peripheral blood stem cell transplantation|
16370714|NCT00004172|Radiation|radiation therapy|
16370715|NCT00091624|Drug|CC-5013|
16370716|NCT00091598|Drug|Ambrisentan|
16370717|NCT00091585|Drug|SNS-595|
16370718|NCT00091572|Drug|Temozolomide|"oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days (7 days on / 7 days off continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop."
16370719|NCT00091572|Drug|Dacarbazine|intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
16370720|NCT00091559|Drug|MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months|
16370721|NCT00004089|Biological|filgrastim|
16370722|NCT00004089|Drug|fluorouracil|
16370723|NCT00004089|Drug|hydroxyurea|
16370724|NCT00004089|Drug|paclitaxel|
16370725|NCT00004089|Procedure|conventional surgery|
16370726|NCT00004089|Radiation|radiation therapy|
16370727|NCT00004083|Drug|cisplatin liposomal|
16370728|NCT00004014|Drug|pegylated liposomal doxorubicin hydrochloride|Doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter.
16370729|NCT00003956|Drug|fluorouracil|
16370730|NCT00003956|Drug|leucovorin calcium|
16370731|NCT00003956|Drug|lonafarnib|
16370732|NCT00003858|Drug|mitoxantrone hydrochloride|
16370733|NCT00003842|Biological|interleukin-4 PE38KDEL cytotoxin|
16370734|NCT00003842|Drug|isolated perfusion|
16370735|NCT00003842|Procedure|surgical procedure|
16370736|NCT00003780|Biological|tumor infiltrating lymphocyte therapy|
16370737|NCT00003780|Drug|gemcitabine hydrochloride|
16370738|NCT00003775|Drug|leflunomide|
16370739|NCT00003714|Drug|Pyrazoloacridine|IV (by vein) over 3 hours every 3 weeks
16370740|NCT00003711|Drug|irinotecan hydrochloride|
16370741|NCT00003711|Drug|pemetrexed disodium|
16370742|NCT00091611|Drug|IL-2 (interleukin-2)|
16370743|NCT00091611|Drug|OKT3|
16370744|NCT00091611|Drug|Cyclophosphamide|
16370745|NCT00091611|Drug|Fludarabine|
16370746|NCT00091611|Drug|Mesna|
16370747|NCT00091507|Drug|GIK|Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.
16370748|NCT00091507|Drug|Placebo|Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
16370749|NCT00091481|Drug|Zemplar|
16370750|NCT00091442|Drug|Docetaxel|Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
16370751|NCT00091442|Drug|DOXIL|DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
16370752|NCT00004057|Drug|L-778,123|
16370753|NCT00004057|Drug|paclitaxel|
16370754|NCT00004036|Biological|sargramostim|
16370755|NCT00004036|Drug|amifostine trihydrate|
16370756|NCT00004036|Drug|carboplatin|
16370757|NCT00004036|Drug|cyclophosphamide|
16370758|NCT00004022|Biological|aldesleukin|
16370759|NCT00004022|Biological|autologous tumor cell vaccine|
16370760|NCT00004022|Biological|muromonab-CD3|
16370761|NCT00004022|Biological|therapeutic autologous lymphocytes|
16370762|NCT00004022|Procedure|surgical procedure|
16370763|NCT00003673|Drug|chemotherapy|
16370764|NCT00003673|Drug|gemtuzumab ozogamicin|
16370765|NCT00003671|Drug|asparaginase|
16370766|NCT00003671|Drug|cyclophosphamide|
16370767|NCT00003671|Drug|cytarabine|
16370768|NCT00003671|Drug|daunorubicin hydrochloride|
16370769|NCT00003671|Drug|dexamethasone|
16370770|NCT00003671|Drug|leucovorin calcium|
16370771|NCT00003671|Drug|mercaptopurine|
16370772|NCT00003671|Drug|methotrexate|
16370773|NCT00003671|Drug|thioguanine|
16370774|NCT00003671|Drug|vincristine sulfate|
16370775|NCT00003666|Drug|6-hydroxymethylacylfulvene|11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
16370776|NCT00003634|Biological|oregovomab|
16370777|NCT00003625|Drug|cyclosporine|
16370778|NCT00003625|Drug|etoposide|
16370779|NCT00003625|Drug|vincristine sulfate|
16370780|NCT00003625|Radiation|radiation therapy|
16370781|NCT00003599|Dietary Supplement|Vitamin E (AT)|Orally daily
16370782|NCT00003599|Drug|Isotretinoin|Orally daily
16370783|NCT00003591|Drug|paclitaxel|
16370784|NCT00003591|Radiation|radiation therapy|
16370785|NCT00003587|Drug|carboplatin|AUC=5.5 day 1 every 21 days X 3
16370786|NCT00003587|Drug|cisplatin|IV cisplatin 100 mg/m^2 day 1 every 21 days X 3
16370787|NCT00003587|Drug|docetaxel|IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
16370788|NCT00003587|Drug|gemcitabine|IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3
16370789|NCT00003587|Drug|paclitaxel|IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
16370790|NCT00003587|Drug|vinorelbine|IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3
16370791|NCT00003564|Drug|Isotretinoin|Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.
16370792|NCT00003564|Drug|Procarbazine Hydrochloride|"Arm I: Oral procarbazine once daily on days 1-14 every 28 days for 6 courses of combined therapy.
~Arm II: Oral procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses."
16370793|NCT00003551|Drug|aminocamptothecin colloidal dispersion|
16370794|NCT00003546|Drug|gemcitabine hydrochloride|given IV
16370795|NCT00003546|Radiation|radiation therapy|1.8 Gy to tumor bed
16370796|NCT00003451|Biological|recombinant interferon alfa|
16370797|NCT00003451|Biological|recombinant interleukin-12|
16370798|NCT00003441|Drug|Irofulven (MGI-114)|IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.
16370799|NCT00003430|Drug|L-778,123|
16370800|NCT00003428|Drug|arzoxifene hydrochloride|
16370801|NCT00003353|Biological|filgrastim|
16370802|NCT00003353|Drug|melphalan|
16370803|NCT00003353|Procedure|bone marrow ablation with stem cell support|
16370804|NCT00003353|Procedure|peripheral blood stem cell transplantation|
16370805|NCT00003344|Drug|irinotecan hydrochloride|
16370806|NCT00003344|Radiation|radiation therapy|
16370807|NCT00003339|Biological|gp100 antigen|
16370808|NCT00003339|Biological|incomplete Freund's adjuvant|
16370809|NCT00003339|Biological|recombinant interleukin-12|
16370810|NCT00003339|Biological|tyrosinase peptide|
16370811|NCT00003331|Drug|fluorouracil|
16370812|NCT00003331|Drug|leucovorin calcium|
16370813|NCT00003331|Drug|topotecan hydrochloride|
16370814|NCT00003288|Biological|filgrastim|
16370815|NCT00003288|Drug|cyclophosphamide|
16370816|NCT00003288|Drug|tirapazamine|
16370817|NCT00003263|Biological|recombinant interferon alfa|vaccine
16370818|NCT00003263|Drug|cisplatin|
16370819|NCT00003263|Procedure|surgical procedure|
16370820|NCT00003263|Radiation|radiation therapy|
16370821|NCT00091429|Drug|Ranolazine|
16370822|NCT00003257|Biological|Ad5CMV-p53 gene|
16370823|NCT00003252|Drug|amifostine trihydrate|
16370824|NCT00003248|Biological|rituximab|
16370825|NCT00003248|Drug|fludarabine phosphate|
16370826|NCT00003241|Drug|phenylacetate|
16370827|NCT00003223|Drug|fenretinide|200 mg/day PO, days 1-25 q 28 days x 6 cycles.
16370828|NCT00091416|Biological|VRC-HIVADV014-00-VP|
16370829|NCT00091390|Radiation|High Dose brachytherapy boost|19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.
16370830|NCT00091390|Radiation|External beam radiotherapy|45 Gy as 1.8 Gy five days a week for five weeks.
16370831|NCT00091377|Drug|cisplatin|IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
16370832|NCT00091377|Drug|paclitaxel|IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
16370833|NCT00091377|Drug|phenoxodiol|IV 3 mg/kg
16370834|NCT00091351|Procedure|conventional surgery|
16370835|NCT00091351|Radiation|radiation therapy|
16370836|NCT00091338|Biological|MART-1 antigen|
16370837|NCT00091338|Biological|gp100 antigen|
16370838|NCT00091338|Biological|incomplete Freund's adjuvant|
16370839|NCT00091338|Biological|recombinant interleukin-7|
16370840|NCT00091325|Dietary Supplement|defined green tea catechin extract|
16370841|NCT00091312|Drug|FOLFIRI regimen|
16370842|NCT00091312|Drug|fluorouracil|
16370843|NCT00091312|Drug|irinotecan hydrochloride|
16370844|NCT00091312|Drug|leucovorin calcium|
16370845|NCT00091312|Procedure|adjuvant therapy|
16370846|NCT00091299|Drug|warfarin|
16370847|NCT00091286|Biological|HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine|
16370848|NCT00091273|Biological|incomplete Freund's adjuvant|
16370849|NCT00091273|Biological|ovarian cancer peptide vaccine|
16370850|NCT00091273|Biological|sargramostim|
16370851|NCT00091273|Biological|tetanus toxoid helper peptide|
16370852|NCT00091273|Procedure|adjuvant therapy|
16370853|NCT00091260|Drug|dexamethasone|dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
16370854|NCT00091260|Drug|lenalidomide|15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
16370855|NCT00091247|Drug|tetracycline hydrochloride|
16370856|NCT00091247|Other|placebo|
16370857|NCT00091234|Drug|gemtuzumab ozogamicin|
16370858|NCT00091195|Drug|romidepsin|
16370859|NCT00091182|Drug|oxaliplatin|Given IV
16370860|NCT00091169|Dietary Supplement|levocarnitine|Given orally
16370861|NCT00091169|Other|placebo|Given orally
16370862|NCT00091156|Drug|gefitinib|
16370863|NCT00091156|Procedure|adjuvant therapy|
16370864|NCT00091143|Biological|gp100 antigen|
16370865|NCT00091143|Biological|incomplete Freund's adjuvant|
16370866|NCT00091143|Biological|keyhole limpet hemocyanin|
16370867|NCT00091143|Drug|fludarabine phosphate|
16370868|NCT00091143|Procedure|peripheral blood stem cell transplantation|
16370869|NCT00091130|Biological|HspE7|Given SC
16370870|NCT00091130|Other|placebo|Given SC
16370871|NCT00091130|Other|laboratory biomarker analysis|Correlative studies
16370872|NCT00091117|Drug|bortezomib|Given IV
16370873|NCT00091117|Other|pharmacological study|Correlative studies
16370874|NCT00091104|Biological|MART-1:27-35 peptide vaccine|
16370875|NCT00091104|Biological|aldesleukin|
16370876|NCT00091104|Biological|filgrastim|
16370877|NCT00091104|Biological|incomplete Freund's adjuvant|
16370878|NCT00091104|Biological|therapeutic autologous lymphocytes|
16370880|NCT00091104|Drug|cyclophosphamide|
16370881|NCT00091104|Drug|fludarabine phosphate|
16370882|NCT00091104|Procedure|autologous hematopoietic stem cell transplantation|
16370883|NCT00091104|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16370884|NCT00091104|Radiation|total-body irradiation|
16370885|NCT00091091|Other|medical chart review|
16370886|NCT00091091|Other|questionnaire administration|
16370887|NCT00091091|Procedure|management of therapy complications|
16370888|NCT00091078|Biological|oblimersen sodium|Given IV
16370889|NCT00091078|Drug|imatinib mesylate|Given orally
16370890|NCT00091078|Other|laboratory biomarker analysis|Correlative studies
16370891|NCT00091052|Biological|sargramostim|
16370892|NCT00091052|Radiation|radiation therapy|
16370893|NCT00091039|Biological|recombinant fowlpox GM-CSF vaccine adjuvant|
16370894|NCT00091039|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
16370895|NCT00091039|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|
16370896|NCT00091039|Drug|carboplatin|
16370897|NCT00091039|Drug|paclitaxel|
16370898|NCT00091039|Radiation|radiation therapy|
16370899|NCT00091026|Biological|cetuximab|Given IV
16370900|NCT00091026|Drug|gemcitabine hydrochloride|Given IV
16370901|NCT00091026|Biological|bevacizumab|Given IV
16370902|NCT00091026|Drug|erlotinib hydrochloride|Given orally
16370903|NCT00090987|Drug|imatinib mesylate|400 mg orally once a day for up to 6 months.
16370904|NCT00090974|Procedure|quality-of-life assessment|
16370905|NCT00090961|Other|educational intervention|
16370906|NCT00090961|Other|supervised exercise program|
16370907|NCT00090909|Drug|cisplatin|
16370908|NCT00090909|Drug|dexamethasone|
16370909|NCT00090909|Drug|gemcitabine hydrochloride|
16370910|NCT00090896|Biological|maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody|
16370911|NCT00090870|Biological|PEG-interferon alfa-2b|Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
16370912|NCT00090870|Biological|GM-CSF|GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
16370913|NCT00090870|Drug|thalidomide|200mg daily by mouth
16370914|NCT00090857|Drug|Letrozole|
16370915|NCT00090857|Other|Placebo|
16370916|NCT00090844|Drug|triptorelin|3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection
16370917|NCT00090779|Drug|Emtricitabine/ tenofovir disoproxil fumarate|once daily
16370918|NCT00090779|Drug|Lopinavir/Ritonavir|twice daily
16370919|NCT00090766|Drug|valganciclovir [Valcyte]|po daily (dose based on body surface area and CrCL)
16370920|NCT00090753|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
16370921|NCT00090753|Drug|Epoetin alfa|Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
16370922|NCT00090753|Drug|Epoetin beta|Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
16370923|NCT00090753|Drug|Darbepoetin alfa|Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
16370924|NCT00090727|Drug|AQ4N|
16370925|NCT00090714|Genetic|pVGI.1(VEGF2)|
16370926|NCT00090701|Drug|AG2037|
16370927|NCT00003217|Biological|filgrastim|
16370928|NCT00003217|Drug|cyclophosphamide|
16370929|NCT00003217|Drug|cytarabine|
16370930|NCT00003217|Drug|dexamethasone|
16370931|NCT00003217|Drug|doxorubicin hydrochloride|
16370932|NCT00003217|Drug|methotrexate|
16370933|NCT00003217|Drug|vincristine sulfate|
16370934|NCT00003172|Biological|filgrastim|
16370935|NCT00003172|Biological|recombinant interferon alfa|
16370936|NCT00003172|Drug|docetaxel|
16370937|NCT00003172|Drug|doxorubicin hydrochloride|
16370938|NCT00003172|Drug|fluorouracil|
16370939|NCT00003172|Drug|hydroxyurea|
16370940|NCT00003170|Dietary Supplement|glutamine|
16370941|NCT00003170|Other|placebo|
16370942|NCT00003139|Drug|pilocarpine hydrochloride|5mg pilocarpine hydrochloride tablets
16370943|NCT00003139|Other|Placebo|
16370944|NCT00003134|Drug|irinotecan hydrochloride|
16370945|NCT00003100|Dietary Supplement|soy isoflavones|
16370946|NCT00003088|Drug|cyclophosphamide|given IV
16370947|NCT00003088|Drug|doxorubicin hydrochloride|given IV
16370948|NCT00003088|Drug|paclitaxel|given IV
16370949|NCT00003072|Drug|amifostine trihydrate|
16370950|NCT00003072|Drug|carboplatin|
16370951|NCT00003072|Drug|paclitaxel|
16370952|NCT00003048|Drug|Amifostine Trihydrate|Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
16370953|NCT00003039|Drug|alvocidib|
16370954|NCT00090688|Biological|meCS6 + LT(R192G)|
16370955|NCT00090675|Drug|ZD1839|
16370956|NCT00003005|Drug|Cordycepin|"Dose escalation study using the following doses:
~6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2"
16370957|NCT00003005|Drug|Deoxycoformycin|Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous
16370958|NCT00002993|Drug|cisplatin|
16370959|NCT00002993|Drug|doxorubicin hydrochloride|
16370960|NCT00002993|Drug|mitomycin C|
16370961|NCT00002980|Drug|decitabine|
16370962|NCT00002967|Drug|cyclophosphamide|
16370963|NCT00002967|Drug|doxorubicin hydrochloride|
16370964|NCT00002967|Drug|octreotide pamoate|
16370965|NCT00002967|Drug|tamoxifen citrate|
16370966|NCT00002946|Drug|penclomedine|
16370967|NCT00002942|Procedure|autologous bone marrow transplantation|
16370968|NCT00002942|Procedure|peripheral blood stem cell transplantation|
16370969|NCT00002937|Drug|paclitaxel|
16370970|NCT00002937|Drug|valspodar|
16370971|NCT00002932|Drug|cisplatin|
16370972|NCT00002932|Radiation|radiation therapy|
16370973|NCT00002904|Drug|trabectedin|
16370974|NCT00002897|Drug|cisplatin|
16370975|NCT00002897|Drug|fluorouracil|
16370976|NCT00002897|Procedure|conventional surgery|
16370977|NCT00002873|Radiation|brachytherapy|
16370978|NCT00002872|Biological|bleomycin sulfate|
16370979|NCT00002872|Drug|doxycycline|
16370980|NCT00002872|Other|talc|
16370981|NCT00002811|Drug|liposomal T4N5 lotion|
16370982|NCT00002805|Biological|filgrastim|
16370983|NCT00002805|Drug|cladribine|
16370984|NCT00002805|Drug|cytarabine|
16370985|NCT00002805|Drug|etoposide|
16370986|NCT00002805|Drug|methotrexate|
16370987|NCT00002805|Drug|mitoxantrone hydrochloride|
16370988|NCT00002805|Drug|therapeutic hydrocortisone|
16370989|NCT00002805|Procedure|allogeneic bone marrow transplantation|
16370990|NCT00002805|Procedure|autologous bone marrow transplantation|
16370991|NCT00002805|Procedure|peripheral blood stem cell transplantation|
16370992|NCT00002805|Radiation|low-LET cobalt-60 gamma ray therapy|
16370993|NCT00002805|Radiation|low-LET electron therapy|
16370994|NCT00002805|Radiation|low-LET photon therapy|
16370995|NCT00002793|Drug|fluorouracil|
16370996|NCT00002793|Drug|leucovorin calcium|
16370997|NCT00002791|Biological|filgrastim|
16370998|NCT00002791|Drug|dacarbazine|
16370999|NCT00002791|Drug|doxorubicin hydrochloride|
16371000|NCT00002791|Drug|ifosfamide|
16371001|NCT00002791|Drug|mesna|
16371002|NCT00002791|Procedure|conventional surgery|
16371003|NCT00002791|Radiation|brachytherapy|
16371004|NCT00002791|Radiation|intraoperative radiation therapy|
16371005|NCT00002791|Radiation|radioisotope therapy|
16371006|NCT00002790|Drug|cyclosporine|
16371007|NCT00002790|Drug|methotrexate|
16371008|NCT00002790|Drug|sirolimus|
16371009|NCT00002781|Drug|boronophenylalanine-fructose complex|
16371010|NCT00002775|Drug|docetaxel|
16371011|NCT00002775|Drug|estramustine phosphate sodium|
16371012|NCT00002767|Biological|Detox-B adjuvant|
16371013|NCT00002767|Biological|recombinant interferon alfa|
16371014|NCT00090649|Drug|DVS-233 SR|
16371015|NCT00090623|Drug|rhuFab V2 (ranibizumab)|
16371016|NCT00002744|Drug|asparaginase|
16371017|NCT00002744|Drug|cyclophosphamide|
16371018|NCT00002744|Drug|cytarabine|
16371019|NCT00002744|Drug|daunorubicin hydrochloride|
16371020|NCT00002744|Drug|dexamethasone|
16371021|NCT00002744|Drug|doxorubicin hydrochloride|
16371022|NCT00002744|Drug|mercaptopurine|
16371023|NCT00002744|Drug|methotrexate|
16371024|NCT00002744|Drug|pegaspargase|
16371025|NCT00002744|Drug|prednisone|
16371026|NCT00002744|Drug|therapeutic hydrocortisone|
16371027|NCT00002744|Drug|thioguanine|
16371028|NCT00002744|Drug|vincristine sulfate|
16371029|NCT00002744|Radiation|low-LET cobalt-60 gamma ray therapy|
16371030|NCT00002744|Radiation|low-LET photon therapy|
16371031|NCT00002735|Drug|Induction chemotherapy|Cisplatin and 5-Fluorouracil
16371032|NCT00002735|Drug|cisplatin|Cisplatin 100 mg/m2 IV infusion over 90 minutes Day 1 every 21 days for 2 cycles.
16371033|NCT00002735|Drug|fluorouracil|5-Fluorouracil 1,000 mg/m2/day continuous IV infusion over 24 hours Days 1 through 5 every 21 days for 2 cycles.
16371034|NCT00002735|Radiation|low-LET cobalt-60 gamma ray therapy|180 cGy per day, Days 1-5, every week for eight weeks
16371035|NCT00002730|Drug|buthionine sulfoximine|
16371036|NCT00002730|Drug|melphalan|
16371037|NCT00002703|Radiation|high-LET heavy ion therapy|
16371038|NCT00002703|Radiation|low-LET photon therapy|
16371039|NCT00090610|Drug|Docetaxel|"For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin
~For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin"
16371040|NCT00090610|Drug|Carboplatin|"Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.
~Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel"
16371041|NCT00090584|Drug|Tolterodine|4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
16371042|NCT00090584|Behavioral|Behavioral training|Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
16371043|NCT00090532|Drug|AG-013,958|
16371044|NCT00090519|Drug|ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
16371045|NCT00090519|Drug|placebo|QD oral for up to 36 months
16371046|NCT00090493|Biological|MAGE-A3|vaccinations at 2- week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating the patient 3 times at 14 day intervals (vaccination #4-6: days 82, 96, and 110). Vaccines #4-6 will be identical to vaccines 1-3. Thereafter, 6 monthly vaccines will be given to further boost the anti-MM-T-cells.
16371047|NCT00090493|Biological|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals
16371048|NCT00090480|Biological|HyperAcute - Breast cancer vaccine|Cells will be injected intradermally for four weeks for four cycles. Dosage will vary from 10 million to 100 million HAB cells.
16371049|NCT00002659|Drug|cisplatin-e therapeutic implant|
16371050|NCT00002631|Drug|chemotherapy|
16371051|NCT00002631|Drug|cisplatin|
16371052|NCT00002631|Drug|fluorouracil|
16371053|NCT00002631|Radiation|low-LET electron therapy|
16371054|NCT00002631|Radiation|low-LET photon therapy|
16371055|NCT00002628|Biological|filgrastim|
16371056|NCT00002628|Drug|carboplatin|
16371057|NCT00002628|Drug|cyclophosphamide|
16371058|NCT00002628|Drug|mesna|
16371059|NCT00002628|Drug|paclitaxel|
16371060|NCT00002628|Procedure|peripheral blood stem cell transplantation|
16371061|NCT00002622|Drug|talc|4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
16371062|NCT00002622|Drug|Talc|4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
16371063|NCT00002616|Biological|aldesleukin|
16371064|NCT00002616|Biological|filgrastim|
16371065|NCT00002616|Drug|carboplatin|
16371066|NCT00002616|Drug|cyclophosphamide|
16371067|NCT00002616|Drug|thiotepa|
16371068|NCT00002616|Procedure|peripheral blood stem cell transplantation|
16371069|NCT00002593|Drug|fluorouracil|Given IV as described in Arm Description
16371070|NCT00002593|Drug|leucovorin calcium|Given IV as described in Arm description.
16371071|NCT00002593|Drug|levamisole hydrochloride|Given as described in arm description
16371072|NCT00002570|Drug|fluorouracil|425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days
16371073|NCT00002570|Drug|leucovorin calcium|20 mg/m2 IV - number of cycles is determined by patient and physician
16371074|NCT00002554|Drug|busulfan|
16371075|NCT00002554|Drug|cyclophosphamide|
16371076|NCT00002554|Drug|methotrexate|
16371077|NCT00002554|Procedure|allogeneic bone marrow transplantation|
16371078|NCT00002554|Radiation|radioimmunotherapy|
16371079|NCT00002527|Drug|aspirin|
16371080|NCT00002527|Other|placebo|
16371081|NCT00002509|Biological|filgrastim|
16371082|NCT00002509|Drug|carboplatin|
16371083|NCT00002509|Drug|cyclophosphamide|
16371084|NCT00002509|Drug|etoposide|
16371085|NCT00002509|Drug|mesna|
16371086|NCT00002509|Procedure|autologous bone marrow transplantation|
16371087|NCT00002509|Procedure|peripheral blood stem cell transplantation|
16371088|NCT00090376|Drug|GPI 1485|
16371089|NCT00090363|Drug|ZD4054 15 mg|15 mg oral tablet once daily
16371090|NCT00090363|Drug|Placebo|
16371091|NCT00090363|Drug|ZD4054 10 mg|10mg oral tablet once daily
16371092|NCT00090324|Drug|quetiapine fumarate tablets|
16371093|NCT00090311|Drug|quetiapine fumarate|
16371094|NCT00090298|Drug|MK0653A, ezetimibe (+) simvastatin|
16371095|NCT00090298|Drug|Comparator: Rosuvastatin|
16371096|NCT00004915|Drug|raloxifene|
16371097|NCT00004201|Drug|carboplatin|
16371098|NCT00004201|Drug|cisplatin|
16371099|NCT00004201|Drug|gemcitabine hydrochloride|
16371100|NCT00004090|Drug|cisplatin|
16371101|NCT00004090|Drug|gemcitabine hydrochloride|
16371102|NCT00004029|Biological|recombinant viral vaccine therapy|
16371103|NCT00004029|Biological|sargramostim|
16371104|NCT00002489|Biological|dactinomycin|
16371105|NCT00002489|Biological|filgrastim|
16371106|NCT00002489|Drug|carboplatin|
16371107|NCT00002489|Drug|cyclophosphamide|
16371108|NCT00002489|Drug|doxorubicin hydrochloride|
16371109|NCT00002489|Drug|etoposide|
16371110|NCT00002489|Drug|leucovorin calcium|
16371111|NCT00002489|Drug|methotrexate|
16371112|NCT00002489|Drug|vincristine sulfate|
16371113|NCT00002489|Procedure|conventional surgery|
16371114|NCT00002488|Drug|cisplatin|
16371115|NCT00002488|Drug|cyclophosphamide|
16371116|NCT00002488|Drug|etoposide|
16371117|NCT00002487|Drug|dipyridamole|
16371118|NCT00002487|Drug|methotrexate|
16371119|NCT00002471|Drug|asparaginase|
16371120|NCT00002471|Drug|cyclophosphamide|
16371121|NCT00002471|Drug|cytarabine|
16371122|NCT00002471|Drug|daunorubicin hydrochloride|
16371123|NCT00002471|Drug|dexamethasone|
16371124|NCT00002471|Drug|etoposide|
16371125|NCT00002471|Drug|leucovorin calcium|
16371126|NCT00002471|Drug|methotrexate|
16371127|NCT00002471|Drug|methylprednisolone|
16371128|NCT00002471|Drug|therapeutic hydrocortisone|
16371129|NCT00002471|Drug|thiotepa|
16371130|NCT00002471|Drug|vincristine sulfate|
16371131|NCT00002458|Biological|monoclonal antibody 3F8|
16371132|NCT00090558|Drug|nitroglycerin|
16371133|NCT00090545|Drug|BAY 43-9006|400 mg BAY 43-9006 orally twice daily in 28 day cycles.
16371134|NCT00090506|Behavioral|Yoga|
16371135|NCT00090428|Behavioral|Gluten- and casein-free diet|Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.
16371136|NCT00090428|Behavioral|Placebo controlled diet|Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
16371137|NCT00090415|Behavioral|Intensive behavioral therapy|Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
16371138|NCT00090285|Biological|(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
16371139|NCT00090285|Biological|Comparator: placebo (unspecified)|0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
16371140|NCT00090272|Drug|MK0826, ertapenem sodium|
16371141|NCT00090272|Drug|Comparator: cefotetan|
16371142|NCT00090259|Drug|Losartan 50 mg|50-mg losartan oral tablet
16371143|NCT00090259|Drug|Losartan 150 mg|100-mg losartan oral tablet + 50-mg losartan oral tablet
16371144|NCT00090246|Drug|MK0869, aprepitant|
16371145|NCT00090246|Drug|Comparator: ondansetron IV|
16371146|NCT00090233|Biological|Rotateq™|3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
16371147|NCT00090233|Biological|Comparator: Placebo|3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
16371148|NCT00090220|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine|qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1
16371149|NCT00090220|Biological|Comparator: Placebo|Placebo intramuscular injection in three 0.5 mL doses over 6 months.
16371150|NCT00090207|Drug|MK0869, aprepitant / Duration of Treatment: 3 days|
16371151|NCT00090207|Drug|Comparator: ondansetron / Duration of Treatment: 4 days|
16371152|NCT00090181|Drug|MK0663, etoricoxib / Duration of Treatment: 4 weeks|
16371153|NCT00090181|Drug|Comparator: diclofenac / Duration of Treatment: 4 weeks|
16371154|NCT00090168|Drug|MK0653A , ezetimibe (+) simvastatin|
16371155|NCT00090168|Drug|Comparator: atorvastatin|
16371156|NCT00090168|Drug|Duration of Treatment: 6 weeks|
16371157|NCT00090155|Drug|MK0869, aprepitant|
16371158|NCT00090155|Drug|Comparator: ondansetron IV|
16371159|NCT00004026|Drug|CT-2584|
16371160|NCT00004026|Drug|chemotherapy|
16371161|NCT00004009|Drug|tipifarnib|
16371162|NCT00003989|Biological|ISIS 3521|
16371163|NCT00003962|Biological|aldesleukin|
16371164|NCT00003778|Drug|dolastatin 10|
16371165|NCT00090402|Dietary Supplement|Fish Oil|Fish oil capsule
16371166|NCT00090402|Dietary Supplement|Lipoic Acid|Lipoic acid capsule
16371167|NCT00090402|Other|Fish Oil Placebo|Soybean oil placebo capsule
16371168|NCT00090402|Other|Lipoic Acid Placebo|Lipoic acid (LA) placebo capsule containing no LA
16371169|NCT00090389|Procedure|Chinese Acupuncture|
16371170|NCT00090337|Procedure|acupuncture therapy|Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
16371171|NCT00090337|Procedure|standard follow-up care|Patients undergo standard care
16371172|NCT00090194|Biological|Immune Globulin Intravenous (Human), 10%|
16371173|NCT00090142|Drug|Comparator: Montelukast|Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
16371174|NCT00090142|Drug|Comparator: Placebo|Placebo tablet administered orally as a single witnessed dose before exercise challenge
16371175|NCT00090129|Drug|Onercept|Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
16371176|NCT00090129|Drug|Placebo|Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
16371177|NCT00090116|Drug|Neramexane|
16371178|NCT00090103|Drug|dutasteride 0.5mg once daily for 4 years|combination or single agent
16371179|NCT00090103|Drug|tamsulosin 0.4mg once daily for 4 years|combination agent or single agent
16371180|NCT00090077|Drug|GW695634|
16371181|NCT00003654|Drug|patent blue V dye|
16371182|NCT00003654|Procedure|lymphangiography|
16371183|NCT00003654|Procedure|radionuclide imaging|
16371184|NCT00003654|Procedure|sentinel lymph node biopsy|
16371185|NCT00003654|Radiation|technetium Tc 99m sulfur colloid|
16371186|NCT00003601|Drug|fenretinide|
16371187|NCT00003601|Drug|tretinoin|
16371188|NCT00003588|Biological|Ad5CMV-p53 gene|
16371189|NCT00003588|Procedure|laparoscopic surgery|
16371190|NCT00003519|Drug|cyclophosphamide|
16371191|NCT00003519|Drug|docetaxel|
16371192|NCT00003519|Drug|doxorubicin hydrochloride|
16371193|NCT00003406|Drug|carboplatin|
16371194|NCT00003406|Drug|docetaxel|
16371195|NCT00003406|Drug|ifosfamide|
16371196|NCT00003406|Procedure|autologous bone marrow transplantation|
16371197|NCT00003406|Procedure|bone marrow ablation with stem cell support|
16371198|NCT00003406|Procedure|peripheral blood stem cell transplantation|
16371199|NCT00003390|Drug|irofulven|
16371200|NCT00003378|Drug|carboplatin|
16371201|NCT00003378|Drug|gemcitabine hydrochloride|
16371202|NCT00003378|Drug|paclitaxel|
16371203|NCT00003362|Biological|QS21|
16371204|NCT00003362|Biological|gp100 antigen|
16371205|NCT00003362|Biological|incomplete Freund's adjuvant|
16371206|NCT00003362|Biological|sargramostim|
16371207|NCT00003362|Biological|tyrosinase peptide|
16371208|NCT00003315|Biological|sargramostim|
16371209|NCT00003315|Drug|liposomal amphotericin B|
16371210|NCT00003304|Drug|temozolomide|
16371211|NCT00090090|Drug|Elsamitrucin|
16371215|NCT00090051|Drug|Rituximab|Intravenous repeating dose
16371216|NCT00090051|Drug|Fludarabine Phosphate|Intravenous repeating dose
16371217|NCT00090051|Drug|Cyclophosphamide|Intravenous repeating dose
16371218|NCT00003279|Biological|BCG vaccine|
16371219|NCT00003279|Biological|monoclonal antibody BEC2|
16371220|NCT00003260|Drug|FOLFIRI regimen|
16371221|NCT00003260|Drug|FOLFOX regimen|
16371222|NCT00003260|Drug|fluorouracil|
16371223|NCT00003260|Drug|irinotecan hydrochloride|
16371224|NCT00003260|Drug|leucovorin calcium|
16371225|NCT00003260|Drug|oxaliplatin|
16371226|NCT00003237|Drug|cisplatin|
16371227|NCT00003237|Drug|paclitaxel|
16371228|NCT00003237|Procedure|surgical procedure|
16371229|NCT00003229|Biological|aldesleukin|
16371230|NCT00003229|Biological|gp100 antigen|
16371231|NCT00003229|Biological|tyrosinase peptide|
16371232|NCT00003224|Biological|QS21|vaccine adjuvant
16371233|NCT00003224|Biological|IFA (incomplete Freund's adjuvant)|Peptides emulsified in IFA.
16371234|NCT00003224|Biological|p946|This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
16371235|NCT00003224|Biological|p946/tet-p|This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p)
16371236|NCT00003224|Biological|Tet-p|modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
16371237|NCT00090038|Drug|rituximab|Dose, schedule,and duration specified in protocol
16371238|NCT00003151|Dietary Supplement|bismuth subcitrate|
16371239|NCT00003151|Drug|amoxicillin|
16371240|NCT00003151|Drug|clarithromycin|
16371241|NCT00003151|Drug|metronidazole hydrochloride|
16371242|NCT00003151|Drug|omeprazole|
16371243|NCT00003151|Drug|tetracycline hydrochloride|
16371244|NCT00003147|Biological|Ad5CMV-p53 gene|
16371245|NCT00003136|Biological|filgrastim|
16371246|NCT00003136|Drug|amifostine trihydrate|
16371247|NCT00003136|Drug|carboplatin|
16371248|NCT00003136|Drug|cyclophosphamide|
16371249|NCT00003136|Procedure|peripheral blood stem cell transplantation|
16371250|NCT00003131|Drug|chemotherapy|
16371251|NCT00003131|Drug|gemtuzumab ozogamicin|
16371252|NCT00002969|Drug|paclitaxel|
16371253|NCT00002960|Biological|recombinant adenovirus-p53 SCH-58500|
16371254|NCT00002888|Drug|cisplatin|
16371255|NCT00002888|Drug|fluorouracil|
16371256|NCT00002888|Drug|paclitaxel|
16371257|NCT00002881|Drug|flutamide|
16371258|NCT00002881|Drug|goserelin acetate|
16371259|NCT00002881|Drug|leuprolide acetate|
16371260|NCT00002881|Drug|suramin|
16371261|NCT00002881|Drug|therapeutic hydrocortisone|
16371262|NCT00002881|Procedure|orchiectomy|
16371263|NCT00002879|Drug|cladribine|
16371264|NCT00002845|Biological|aldesleukin|
16371265|NCT00002783|Drug|cisplatin|
16371266|NCT00002783|Drug|floxuridine|
16371267|NCT00002783|Drug|fluorouracil|
16371268|NCT00002783|Drug|leucovorin calcium|
16371269|NCT00002783|Procedure|conventional surgery|
16371270|NCT00002755|Biological|filgrastim|
16371271|NCT00002755|Drug|CMF regimen|
16371272|NCT00002755|Drug|cyclophosphamide|
16371273|NCT00002755|Drug|doxorubicin hydrochloride|
16371274|NCT00002755|Drug|fluorouracil|
16371275|NCT00002755|Drug|methotrexate|
16371276|NCT00002755|Drug|tamoxifen citrate|
16371277|NCT00002755|Drug|thiotepa|
16371278|NCT00002755|Procedure|autologous bone marrow transplantation|
16371279|NCT00002755|Procedure|peripheral blood stem cell transplantation|
16371280|NCT00002755|Radiation|low-LET cobalt-60 gamma ray therapy|
16371281|NCT00002755|Radiation|low-LET electron therapy|
16371282|NCT00002755|Radiation|low-LET photon therapy|
16371283|NCT00002742|Drug|amphotericin B deoxycholate|
16371284|NCT00002742|Drug|nystatin|
16371285|NCT00002711|Drug|chemotherapy|
16371286|NCT00002711|Drug|cisplatin|
16371287|NCT00002711|Drug|paclitaxel|
16371288|NCT00002711|Radiation|low-LET electron therapy|
16371289|NCT00002711|Radiation|low-LET photon therapy|
16371290|NCT00090025|Drug|becatecarin|Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
16371291|NCT00090025|Drug|5-Fluorouracil Plus Leucovorin|5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle
16371292|NCT00090012|Drug|Olanzapine|
16371293|NCT00090012|Drug|Quetiapine|
16371294|NCT00089999|Drug|Lapatinib|
16371295|NCT00089986|Drug|Intravenous GR270773- Phospholipid Emulsion|
16371296|NCT00089986|Other|Placebo|
16371297|NCT00005024|Drug|carboplatin|
16371298|NCT00005024|Drug|cyclophosphamide|
16371299|NCT00005024|Drug|doxorubicin hydrochloride|
16371300|NCT00005024|Drug|granisetron hydrochloride|
16371301|NCT00004906|Biological|filgrastim|
16371302|NCT00004906|Drug|anastrozole|
16371303|NCT00004906|Drug|carboplatin|
16371304|NCT00004906|Drug|cisplatin|
16371305|NCT00004906|Drug|cyclophosphamide|
16371306|NCT00004906|Drug|docetaxel|
16371307|NCT00004906|Drug|doxorubicin hydrochloride|
16371308|NCT00004906|Drug|etoposide|
16371309|NCT00004906|Drug|pamidronate disodium|
16371310|NCT00004906|Drug|thiotepa|
16371311|NCT00004906|Procedure|peripheral blood stem cell transplantation|
16371312|NCT00002674|Biological|filgrastim|
16371313|NCT00002674|Drug|cytarabine|
16371314|NCT00002674|Drug|etoposide|
16371315|NCT00002674|Drug|hydroxyurea|
16371316|NCT00002674|Drug|mitoxantrone hydrochloride|
16371317|NCT00002674|Procedure|peripheral blood stem cell transplantation|
16371318|NCT00002634|Biological|filgrastim|
16371319|NCT00002634|Biological|monoclonal antibody 3F8|
16371320|NCT00002634|Drug|cisplatin|
16371321|NCT00002634|Drug|cyclophosphamide|
16371322|NCT00002634|Drug|doxorubicin hydrochloride|
16371323|NCT00002634|Drug|etoposide|
16371324|NCT00002634|Drug|mesna|
16371325|NCT00002634|Drug|perfosfamide|
16371326|NCT00002634|Drug|vincristine sulfate|
16371327|NCT00002634|Procedure|autologous bone marrow transplantation|
16371328|NCT00002634|Procedure|in vitro-treated bone marrow transplantation|
16371329|NCT00002634|Radiation|low-LET cobalt-60 gamma ray therapy|
16371330|NCT00002634|Radiation|low-LET photon therapy|
16371331|NCT00002634|Radiation|radioisotope therapy|
16371332|NCT00002579|Drug|CMF regimen|
16371333|NCT00002579|Drug|cyclophosphamide|
16371334|NCT00002579|Drug|fluorouracil|
16371335|NCT00002579|Drug|methotrexate|
16371336|NCT00002579|Drug|tamoxifen citrate|
16371337|NCT00002579|Procedure|conventional surgery|
16371338|NCT00002579|Radiation|radiation therapy|
16371339|NCT00002510|Biological|filgrastim|
16371340|NCT00002510|Drug|cyclophosphamide|
16371341|NCT00002510|Drug|etoposide|
16371342|NCT00002510|Drug|mesna|
16371343|NCT00002510|Procedure|peripheral blood stem cell transplantation|
16371344|NCT00002510|Radiation|radiation therapy|
16371345|NCT00002499|Drug|asparaginase|
16371346|NCT00002499|Drug|cytarabine|
16371347|NCT00002499|Drug|daunorubicin hydrochloride|
16371348|NCT00002499|Drug|dexamethasone|
16371349|NCT00002499|Drug|methotrexate|
16371350|NCT00002499|Drug|prednisone|
16371351|NCT00002499|Drug|vincristine sulfate|
16371352|NCT00002499|Radiation|radiation therapy|
16371353|NCT00002498|Drug|CMF regimen|
16371354|NCT00002498|Drug|cyclophosphamide|
16371355|NCT00002498|Drug|fluorouracil|
16371356|NCT00002498|Drug|methotrexate|
16371357|NCT00002498|Drug|mitoxantrone hydrochloride|
16371358|NCT00002493|Drug|cisplatin|
16371359|NCT00002493|Drug|doxorubicin hydrochloride|
16371360|NCT00002493|Radiation|low-LET photon therapy|
16371361|NCT00002479|Drug|tretinoin|
16371362|NCT00089973|Drug|Ispinesib|Given intravenously at a dose of 18 milligram (mg)/ meter square (m^2).
16371363|NCT00089960|Drug|AMG 706|AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.
16371364|NCT00089947|Drug|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|
16371365|NCT00089921|Drug|SCIO-469|60 mg capsule three times daily for 12 weeks
16371366|NCT00089921|Drug|SCIO-469|30 mg capsule three times daily for 12 weeks
16371367|NCT00089921|Drug|Placebo|2 capsules three times daily and one tablet daily
16371368|NCT00089921|Drug|SCIO-469|100 mg tablet once daily for 12 weeks
16371369|NCT00004900|Biological|filgrastim|
16371370|NCT00004900|Drug|anastrozole|
16371371|NCT00004900|Drug|carboplatin|
16371372|NCT00004900|Drug|cisplatin|
16371373|NCT00004900|Drug|cyclophosphamide|
16371374|NCT00004900|Drug|etoposide|
16371375|NCT00004900|Drug|thiotepa|
16371376|NCT00004900|Procedure|peripheral blood stem cell transplantation|
16371377|NCT00004900|Radiation|radiation therapy|
16371378|NCT00004182|Drug|irinotecan hydrochloride|
16371379|NCT00004136|Procedure|Radiofrequency Ablation|Tumors heated to target temperature by electrodes for maximum of 20 minutes
16371380|NCT00004042|Biological|monoclonal antibody F19|
16371381|NCT00004042|Radiation|iodine I 131 monoclonal antibody F19|
16371382|NCT00003974|Biological|lung tumor associated antigen|
16371383|NCT00003974|Drug|DetoxPC|
16371384|NCT00003974|Drug|chemotherapy|
16371385|NCT00003974|Drug|cyclophosphamide|
16371386|NCT00089908|Biological|rDEN1delta30|Live attenuated rDEN1delta30 vaccine
16371387|NCT00089908|Biological|Placebo|Placebo for rDEN1delta30
16371388|NCT00089895|Drug|Eptifibatide (Integrilin)|intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.
16371389|NCT00089895|Drug|Placebo|intravenous; delivery to match eptifibatide to maintain blind
16371390|NCT00089882|Procedure|APOE Genetic susceptibility testing|
16371391|NCT00089869|Drug|olanzapine|
16371392|NCT00089869|Drug|atomoxetine|
16371393|NCT00089869|Drug|placebo|
16371394|NCT00089856|Biological|Immunotherapy with allogeneic prostate vaccine|Immunotherapy with allogeneic prostate vaccine
16371395|NCT00089856|Drug|Chemotherapy (Taxotere and prednisone)|Chemotherapy (Taxotere and prednisone)
16371396|NCT00003951|Drug|exatecan mesylate|
16371397|NCT00003897|Biological|gp100 antigen|
16371398|NCT00003897|Biological|sargramostim|
16371399|NCT00003885|Drug|arsenic trioxide|
16371400|NCT00003776|Biological|filgrastim|
16371401|NCT00003776|Drug|cisplatin|
16371402|NCT00003776|Drug|doxorubicin hydrochloride|
16371403|NCT00003776|Drug|ifosfamide|
16371404|NCT00003776|Drug|leucovorin calcium|
16371405|NCT00003776|Drug|methotrexate|
16371406|NCT00003776|Drug|trimetrexate glucuronate|
16371407|NCT00003776|Procedure|surgical procedure|
16371408|NCT00003751|Drug|penicillamine|
16371409|NCT00003751|Radiation|radiation therapy|
16371410|NCT00089843|Drug|Testosterone|Testosterone patch 150mcg daily
16371411|NCT00089843|Drug|Actonel (risedronate)|Actonel (risedronate) 35mg PO one time weekly
16371412|NCT00089843|Drug|Placebo Actonel (risedronate)|Placebo tablet identical in appearance to active Actonel (risedronate) tablet
16371413|NCT00089843|Drug|Placebo testosterone|Placebo patch identical in appearance to testosterone patch
16371414|NCT00089830|Drug|MSI-1256F (Squalamine Lactate)|
16371415|NCT00089804|Drug|abetimus sodium (LJP 394) and/or placebo solution|300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks
16371416|NCT00089804|Drug|abetimus sodium (LJP 394)|900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.
16371417|NCT00089804|Drug|Phosphate-buffered saline|A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks
16371418|NCT00003709|Drug|carbendazim|Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
16371419|NCT00003686|Drug|pilocarpine hydrochloride|Pilocarpine 5 mg po qid x 4 weeks
16371420|NCT00003686|Drug|Placebo|Placebo 5 mg po qid x 4 weeks
16371421|NCT00003684|Drug|theophylline|
16371422|NCT00003684|Procedure|quality-of-life assessment|
16371423|NCT00003626|Drug|dolastatin 10|
16371424|NCT00003556|Biological|ALVAC-hB7.1|
16371425|NCT00003556|Biological|canarypox-hIL-12 melanoma vaccine|
16371426|NCT00089791|Drug|placebo|Placebo administered by subcutaneous injection
16371427|NCT00089791|Drug|Denosumab|Denosumab 60 mg administered by subcutaneous injection
16371428|NCT00089752|Device|Continuous Positive Airway Pressure (CPAP) Treatment|CPAP device used at night
16371429|NCT00089752|Device|Sham CPAP device - CPAP device with pressure delivered <1 cm H20|Sham CPAP device used at night
16371430|NCT00003555|Drug|amifostine trihydrate|
16371431|NCT00003555|Drug|paclitaxel|
16371432|NCT00003543|Biological|monoclonal antibody A33|
16371433|NCT00003543|Drug|carmustine|
16371434|NCT00003543|Drug|fluorouracil|
16371435|NCT00003543|Drug|streptozocin|
16371436|NCT00003543|Drug|vincristine sulfate|
16371437|NCT00003400|Biological|filgrastim|
16371438|NCT00003400|Drug|carmustine|
16371439|NCT00003400|Drug|cisplatin|
16371440|NCT00003400|Drug|melphalan|
16371441|NCT00003400|Drug|vinorelbine tartrate|
16371442|NCT00003400|Procedure|peripheral blood stem cell transplantation|
16371443|NCT00003395|Drug|arsenic trioxide|
16371444|NCT00003380|Drug|etoposide|
16371445|NCT00003380|Drug|pegylated liposomal doxorubicin hydrochloride|
16371446|NCT00003360|Radiation|iodine I 131 monoclonal antibody A33|
16371447|NCT00003357|Biological|GM2-KLH vaccine|
16371448|NCT00003357|Biological|QS21|
16371449|NCT00003348|Drug|O6-benzylguanine|
16371450|NCT00003348|Drug|carmustine|
16371451|NCT00003340|Drug|cyclophosphamide|
16371452|NCT00003340|Drug|topotecan hydrochloride|
16371453|NCT00003312|Radiation|iodine I 125|
16371454|NCT00089778|Drug|117-126:Fibroblast growth factor 5 (FGF-5)|Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
16371455|NCT00089778|Drug|Fibroblast growth factor 5 (FGF-5):172-176/217-220|Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.
16371456|NCT00089778|Other|IL-2|720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).
16371457|NCT00089765|Drug|Ranibizumab|
16371458|NCT00003294|Biological|filgrastim|
16371459|NCT00003294|Drug|amifostine trihydrate|
16371460|NCT00003294|Drug|carboplatin|
16371461|NCT00003294|Drug|paclitaxel|
16371462|NCT00003284|Biological|filgrastim|
16371463|NCT00003284|Drug|carboplatin|
16371464|NCT00003284|Drug|etoposide|
16371465|NCT00003284|Drug|ifosfamide|
16371466|NCT00003284|Drug|paclitaxel|
16371467|NCT00003284|Procedure|peripheral blood stem cell transplantation|
16371468|NCT00003284|Radiation|radiation therapy|
16371469|NCT00003251|Drug|amifostine trihydrate|
16371470|NCT00003251|Drug|cisplatin|
16371471|NCT00003251|Drug|paclitaxel|
16371472|NCT00003251|Radiation|radiation therapy|
16371473|NCT00003220|Drug|bryostatin 1|
16371474|NCT00003200|Drug|Taxotere|
16371475|NCT00003200|Radiation|Radiation therapy|
16371476|NCT00089726|Biological|CG8123|
16371477|NCT00089726|Drug|Cyclophosphamide|
16371478|NCT00089713|Drug|alagebrium chloride (ALT-711)|
16371479|NCT00089700|Drug|TNX-355|
16371480|NCT00003197|Dietary Supplement|green tea extract|
16371481|NCT00003123|Drug|amifostine trihydrate|
16371482|NCT00003115|Drug|hydromorphone hydrochloride|
16371483|NCT00003102|Radiation|iodine I 131 chimeric monoclonal antibody G-250|
16371484|NCT00003058|Drug|troglitazone|
16371485|NCT00003044|Drug|cisplatin-e therapeutic implant|
16371486|NCT00003025|Biological|vitespen|
16371487|NCT00003003|Biological|sargramostim|
16371488|NCT00003003|Drug|mitomycin C|
16371489|NCT00003003|Drug|mitoxantrone hydrochloride|
16371490|NCT00002955|Drug|fluorouracil|
16371491|NCT00002955|Drug|leucovorin calcium|
16371492|NCT00002955|Drug|trimetrexate glucuronate|
16371493|NCT00002933|Drug|irinotecan hydrochloride|Irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a complete response may receive additional courses of treatment. Patients are followed until death.
16371494|NCT00089687|Drug|GBR 12909|
16371495|NCT00089674|Drug|AMG 162|60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
16371496|NCT00089674|Drug|Placebo|60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
16371497|NCT00089661|Drug|Placebo|60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
16373635|NCT00003079|Drug|bryostatin 1|
16371498|NCT00089661|Drug|AMG 162 / Denosumab|60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
16371499|NCT00089648|Drug|Sunitinib|50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
16371500|NCT00089635|Drug|Panitumumab|Administered by intravenous infusion
16371501|NCT00002914|Drug|piritrexim|
16371502|NCT00002909|Drug|chemotherapy|
16371503|NCT00002909|Drug|oral sodium phenylbutyrate|
16371504|NCT00002890|Biological|lintuzumab|
16371505|NCT00002865|Biological|filgrastim|
16371506|NCT00002865|Drug|cyclophosphamide|
16371507|NCT00002865|Drug|cytarabine|
16371508|NCT00002865|Drug|dexamethasone|
16371509|NCT00002865|Drug|doxorubicin hydrochloride|
16371510|NCT00002865|Drug|etoposide|
16371511|NCT00002865|Drug|ifosfamide|
16371512|NCT00002865|Drug|leucovorin calcium|
16371513|NCT00002865|Drug|mesna|
16371514|NCT00002865|Drug|methotrexate|
16371515|NCT00002865|Drug|therapeutic hydrocortisone|
16371516|NCT00002865|Drug|vincristine sulfate|
16371517|NCT00002865|Radiation|low-LET cobalt-60 gamma ray therapy|
16371518|NCT00002865|Radiation|low-LET photon therapy|
16371519|NCT00002749|Drug|carboplatin|
16371520|NCT00002655|Procedure|cryosurgery|
16371521|NCT00002635|Biological|filgrastim|
16371522|NCT00002635|Drug|aminocamptothecin|
16371523|NCT00002619|Biological|filgrastim|
16371524|NCT00002619|Drug|carboplatin|
16371525|NCT00002619|Drug|thiotepa|
16371526|NCT00002619|Procedure|autologous bone marrow transplantation|
16371527|NCT00002619|Procedure|peripheral blood stem cell transplantation|
16371528|NCT00002609|Biological|lintuzumab|
16371529|NCT00002609|Drug|cytarabine|
16371530|NCT00002609|Drug|idarubicin|
16371531|NCT00002585|Drug|pyrazoloacridine|
16371532|NCT00089596|Procedure|Expansion of umbilical cord stem cells|
16371533|NCT00089583|Drug|LEXIVA (GW433908)|Fosamprenavir suspension or tablet bid
16371534|NCT00089583|Drug|Ritonavir|Ritonavir solution bid
16371535|NCT00005626|Drug|Irinotecan|Irinotecan as outlined in treatment arm
16371536|NCT00005607|Drug|FOLFIRI regimen|
16371537|NCT00005607|Drug|fluorouracil|
16371538|NCT00005607|Drug|irinotecan hydrochloride|
16371539|NCT00005607|Drug|leucovorin calcium|
16371540|NCT00002574|Biological|recombinant interferon alfa|
16371541|NCT00002574|Drug|omacetaxine mepesuccinate|
16371542|NCT00002562|Drug|paclitaxel|
16371543|NCT00002507|Drug|mitomycin C|
16371544|NCT00002507|Drug|porfiromycin|
16371545|NCT00002507|Radiation|brachytherapy|
16371546|NCT00002507|Radiation|radiation therapy|
16371547|NCT00089622|Drug|Intravenous Levodopa|
16371548|NCT00089622|Drug|Lisuride Transdermal System|
16371549|NCT00089609|Drug|Docetaxel|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days.
16371550|NCT00089609|Drug|Thalidomide|Thalidomide 200 mg by mouth daily throughout the cycle.
16371551|NCT00089609|Drug|Prednisone|Prednisone 10 mg by mouth daily throughout the cycle.
16371552|NCT00089609|Biological|bevacizumab|Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
16371553|NCT00089609|Genetic|polymorphism analysis|Two buffy coat tubes (two 7mL blue tiger top tubes) will be obtained and wrapped in foil when the patient enters onto the study. DNA (deoxyribonucleic acid) will be isolated only for the purpose of genotype analysis of enzymes with putative relevance for docetaxel or thalidomide disposition.
16371554|NCT00089609|Other|immunoenzyme technique|The PBMC (peripheral blood mononuclear cells) of patients will be analyzed pre-treatment and post cycle 2 for any changes in the function of regulatory T cells. The following analysis will be performed: flow cytometry analysis, CD4 CD25 T cell enrichment, and immunosuppression assay.
16371555|NCT00089609|Other|laboratory biomarker analysis|Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels.
16371556|NCT00089609|Other|pharmacological study|Plasma concentrations of docetaxel and thalidomide will be determined to assess interactions between docetaxel (and thalidomide) and the concomitant therapy.The analysis will be performed using a validated method based on liquid chromotography with mass-spectrometric detection.
16371557|NCT00089570|Drug|terlipressin|
16371558|NCT00089570|Drug|Placebo|
16371559|NCT00089557|Drug|Capsaicin Dermal Patch|
16371560|NCT00089544|Drug|Dacarbazine|Given IV
16371561|NCT00089544|Drug|Doxorubicin Hydrochloride|Given IV
16371562|NCT00089544|Biological|Filgrastim|Given subcutaneously
16371563|NCT00089544|Drug|Ifosfamide|Given IV
16371564|NCT00089544|Other|Laboratory Biomarker Analysis|Correlative studies
16371565|NCT00089544|Radiation|Radiation Therapy|Undergo radiotherapy
16371566|NCT00089544|Drug|Thalidomide|Given orally
16371567|NCT00089544|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16371568|NCT00005591|Biological|cetuximab|
16371569|NCT00005591|Drug|gemcitabine hydrochloride|
16371570|NCT00005076|Biological|cetuximab|
16371571|NCT00005076|Drug|irinotecan hydrochloride|
16371572|NCT00005070|Drug|irofulven|
16371573|NCT00005057|Biological|adenovirus RSV-TK|
16371574|NCT00005057|Drug|ganciclovir|
16371575|NCT00005056|Drug|bryostatin 1|
16371576|NCT00004937|Drug|acridine carboxamide|
16371577|NCT00004219|Drug|granisetron hydrochloride|
16371578|NCT00004219|Drug|lerisetron|
16371579|NCT00004219|Radiation|radiation therapy|
16371580|NCT00004215|Biological|filgrastim|
16371581|NCT00004215|Biological|leridistim|
16371582|NCT00004215|Drug|cytarabine|
16371583|NCT00004215|Drug|daunorubicin hydrochloride|
16371584|NCT00004207|Drug|liposomal daunorubicin citrate|
16371585|NCT00089531|Drug|VRC-HIVDNA016-00-VP|
16371586|NCT00089518|Drug|Valsartan|
16371587|NCT00089505|Drug|Emtricitabine|200 mg taken orally
16371588|NCT00089505|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200/300 mg taken orally
16371589|NCT00089505|Drug|Lopinavir/Ritonavir|400/100 mg taken orally
16371590|NCT00089505|Drug|Nevirapine|200 mg taken orally
16371591|NCT00089505|Drug|Tenofovir disoproxil fumarate|300 mg taken orally
16371592|NCT00089492|Drug|Optimized Background ARVs|As prescribed
16371593|NCT00089492|Drug|enfuvirtide [Fuzeon]|180mg sc once daily for 48 weeks
16371594|NCT00089492|Drug|enfuvirtide [Fuzeon]|90mg sc bid for 48 weeks
16371595|NCT00089479|Drug|capecitabine [Xeloda]|825mg/m2 po bid on days 1-14 of each 3 week cycle
16371596|NCT00089479|Drug|Taxotere|75mg/m2 iv on day 1 of each 3 week cycle
16371597|NCT00089479|Drug|Taxotere|100mg/m2 iv on day 1 of each 3 week cycle
16371598|NCT00089466|Drug|AMD11070|AMD11070 taken daily. Dosage dependent on arm.
16371599|NCT00089453|Drug|Dexamethasone|Dexamthasone 40mg every day, days -5 to -1 only will be given.
16371600|NCT00089453|Drug|Cyclophosphamide|A dose of 60mg/kg (using calculated body weight - see appendix A.) will be infused on day-3, and -2. Cyclophosphamide is administered by intravenous infusion over 2-4 hrs in 250 mLs of Normal Saline (0.9%) or D5W Standard MESNA (60% or 36mg/kg) protection to prevent hemorrhagic cystitis will be given on day -3, -2 and -1.
16371601|NCT00089453|Drug|Melphalan|Melphalan will be given as a single dose of 140mg/m2 on day -1. Subject weighing more than 60kg will be dosed according to their calculated body weight.Melphalan will be diluted in normal saline(0.9%NaCl) to a concentration of 1.5mg/ml. A dose of 140mg/m2 will be administered intravenously over a period <or= 20 minutes on day -1.
16371602|NCT00089453|Drug|Fludarabine|dose of 1.0mg/m2 on days -8,-5,-2.
16371603|NCT00089453|Drug|Bortezomide|A dose of 1.0mg/m2 will be given as a bolus dose on day-8, day-5 and day-2 as per standard practice
16371604|NCT00089453|Procedure|Leukapheresis|On day 0 to collect donor cells for NK cell isolation
16371605|NCT00089453|Drug|Interleukin|2 at 3x10x6 IU on days +1 to 13.
16371606|NCT00089453|Procedure|Infusion #1|Infusion of donor NK Cells #1 on day 0
16371607|NCT00089453|Procedure|Leukapheresis #2|on day +2
16371608|NCT00089453|Procedure|Infusion #2|on day +2
16371609|NCT00089453|Procedure|Auto Graft|on day +14
16371610|NCT00089440|Drug|Aripiprazole|
16371611|NCT00089427|Drug|IL13-PE38QQR|
16371612|NCT00089427|Procedure|Surgery for placement|
16371613|NCT00089427|Procedure|Radiation therapy|
16371614|NCT00089427|Drug|Temozolomide with radiation therapy|
16371615|NCT00089414|Drug|Ethinyl Estradiol/Drospirenone|Drug administered dependent upon arm.
16371616|NCT00089414|Drug|Placebo|
16371617|NCT00089414|Drug|CDB 2914|
16371618|NCT00089401|Drug|isolated perfusion|
16371619|NCT00089401|Drug|melphalan|
16371620|NCT00089401|Procedure|conventional surgery|
16371621|NCT00089388|Drug|cilengitide|Given IV
16371622|NCT00089362|Drug|alvespimycin hydrochloride|Given IV
16371623|NCT00089362|Other|laboratory biomarker analysis|Correlative studies
16371624|NCT00089362|Other|pharmacological study|Correlative studies
16371625|NCT00089349|Biological|alemtuzumab|Given IV
16371626|NCT00089349|Drug|methotrexate|Given IV
16371627|NCT00089349|Drug|mercaptopurine|Given PO
16371628|NCT00089323|Procedure|Bone Marrow Aspiration|
16371629|NCT00089310|Radiation|technetium-99|0.25 mCi in 4 equal doses
16371630|NCT00089297|Biological|Cetuximab|"Induction: An initial dose of cetuximab (C225) 400 mg/m2 (over 2 hours) was given week 1 only. Then, C225 was administered at dose of 250 mg/m2 (over 1 hour) weekly for 5 weeks.
~Concurrent Chemoradiation (Weeks 9-13): C225 was administered at 250 mg/m2/wk (over 1 hour).
~Restaging Biopsy of Primary Site (Week 14): Patients with positive biopsy of the primary site at week 7 or patients without a clinical complete response at the primary site after induction therapy were scheduled for re-biopsy of the primary site at week 14 after concurrent therapy (50 Gy). If the biopsy were negative after concurrent therapy, the patients were scheduled to continue concurrent therapy to complete radiation (68-72 Gy).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
16371631|NCT00089297|Drug|Carboplatin|"Induction Therapy (Week 1-6): The induction chemotherapy starting at week 1 included paclitaxel 90 mg/m2 IV over 1 hour weekly and carboplatin AUC = 2 IV over 30 minutes weekly. The paclitaxel and carboplatin doses were given on the same day, 1 hour after C225 dose was administered. For paclitaxel and carboplatin therapy, rounding of doses (to next decimal if above 0.5 and to lower decimal if below 0.5) was permitted.
~Concurrent Chemoradiation (Weeks 9-13): Concurrent chemotherapy was consisted of paclitaxel following cetuximab at 30 mg/m2/wk (over 1 hour) and carboplatin following paclitaxel at AUC = 1/week (over 15 minutes).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
16371632|NCT00089297|Drug|Paclitaxel|"Induction Therapy (Week 1-6): The induction chemotherapy starting at week 1 included paclitaxel 90 mg/m2 IV over 1 hour weekly and carboplatin AUC = 2 IV over 30 minutes weekly. The paclitaxel and carboplatin doses were given on the same day, 1 hour after C225 dose was administered. For paclitaxel and carboplatin therapy, rounding of doses (to next decimal if above 0.5 and to lower decimal if below 0.5) was permitted.
~Concurrent Chemoradiation (Weeks 9-13): Concurrent chemotherapy was consisted of paclitaxel following cetuximab at 30 mg/m2/wk (over 1 hour) and carboplatin following paclitaxel at AUC = 1/week (over 15 minutes).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
16371749|NCT00088829|Drug|Paclitaxel|All patients will receive paclitaxel neoadjuvantly
16371750|NCT00088816|Drug|cisplatin|
16371751|NCT00088816|Drug|tegafur-gimeracil-oteracil potassium|
16371752|NCT00088816|Procedure|adjuvant therapy|
16371753|NCT00088816|Procedure|conventional surgery|
16371633|NCT00089297|Radiation|Radiation therapy|"Concurrent Chemoradiation (Weeks 9-13): Radiation was given at 200cGy/d/5 weeks for a total dose of 50Gy (5000 cGy). Patients with a negative initial biopsy at week 7 were scheduled to continue concurrent therapy to complete radiation (68-72Gy).
~If the biopsy was negative after concurrent therapy, the patients were scheduled to continue concurrent therapy to complete radiation (68-72 Gy).
~Additional Concurrent Chemoradiation (weeks 15, 16 and 17): Concurrent therapy was consisted of C225 at 250mg/m2/week IV over 1 hour followed by paclitaxel 30mg/m2/week IV over 1 hour followed by carboplatin AUC = 1/week over 15 minutes and RT for three weeks."
16371634|NCT00089284|Drug|Rituxan|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
16371635|NCT00089284|Drug|motexafin gadolinium|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
16371636|NCT00089284|Drug|111Indium-Zevalin and 90Yttrium-Zevalin|Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
16371637|NCT00089271|Drug|alvespimycin hydrochloride|Given IV
16371638|NCT00089271|Other|laboratory biomarker analysis|Correlative studies
16371639|NCT00089258|Biological|beta-glucan|
16371640|NCT00089258|Biological|monoclonal antibody 3F8|
16371641|NCT00089258|Biological|sargramostim|
16371642|NCT00089258|Drug|isotretinoin|
16371643|NCT00089245|Drug|Iodine I 131 MOAB 8H9|Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.
16371644|NCT00089245|Drug|Iodine I 131 MOAB 8H9|The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.
16371645|NCT00089219|Biological|IFA|vaccine adjuvant
16371646|NCT00089219|Biological|6MHP|melanoma helper peptides
16371647|NCT00089219|Biological|GM-CSF|vaccine adjuvant
16371648|NCT00089206|Biological|incomplete Freund's adjuvant|
16371649|NCT00089206|Biological|multi-epitope melanoma peptide vaccine|
16371650|NCT00089206|Biological|sargramostim|
16371651|NCT00089193|Biological|incomplete Freund's adjuvant|
16371652|NCT00089193|Biological|multi-epitope melanoma peptide vaccine|
16371653|NCT00089193|Biological|sargramostim|
16371654|NCT00089180|Drug|liposomal T4N5 lotion|Given topically
16371655|NCT00089180|Other|placebo|Given topically
16371656|NCT00089180|Other|laboratory biomarker analysis|Correlative studies
16371657|NCT00089167|Biological|filgrastim|
16371658|NCT00089167|Drug|dexamethasone|
16371659|NCT00089167|Drug|melphalan|
16371660|NCT00089167|Drug|thalidomide|
16371661|NCT00089154|Biological|apolizumab|Given IV
16371662|NCT00089154|Other|laboratory biomarker analysis|Correlative studies
16371663|NCT00089154|Other|pharmacological study|Correlative studies
16371664|NCT00089141|Drug|mycophenolate mofetil|Given orally
16371665|NCT00089141|Drug|placebo|Given orally
16371666|NCT00089128|Drug|gemcitabine hydrochloride|
16371667|NCT00089128|Drug|irinotecan hydrochloride|
16371668|NCT00089115|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16371669|NCT00089115|Biological|rituximab|
16371670|NCT00089115|Biological|sargramostim|
16371671|NCT00089102|Drug|gemcitabine hydrochloride|1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
16371672|NCT00089102|Drug|irinotecan hydrochloride|100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
16371673|NCT00089089|Drug|decitabine|Given IV
16371674|NCT00089089|Other|pharmacological study|Correlative studies
16371675|NCT00089089|Other|laboratory biomarker analysis|Correlative studies
16371676|NCT00089076|Biological|ipilimumab|Given IV
16371677|NCT00089076|Other|laboratory biomarker analysis|Correlative studies
16371678|NCT00089063|Biological|tyrosinase peptide|Given SC
16371679|NCT00089063|Biological|gp100 antigen|Given SC
16371680|NCT00089063|Biological|MART-1 antigen|Given SC
16371681|NCT00089063|Biological|incomplete Freund's adjuvant|Given SC
16371682|NCT00089063|Drug|Montanide ISA 51 VG|Given SC
16371683|NCT00089063|Biological|sargramostim|Given SC
16371684|NCT00089063|Other|laboratory biomarker analysis|Correlative studies
16371685|NCT00089050|Drug|cyclosporine|
16371686|NCT00089050|Drug|gemtuzumab ozogamicin|
16371687|NCT00089037|Drug|methotrexate|
16371688|NCT00089037|Drug|sirolimus|
16371689|NCT00089037|Drug|tacrolimus|
16371690|NCT00089024|Drug|fluorouracil|2700 mg/m5 IV over 24 hr after gemcitabine weeks 1 & 2; Repeat one 3-week cycle starting day 22
16371691|NCT00089024|Drug|gemcitabine hydrochloride|750 (females) or 900 (males) mg/m5 IV over 30 min (day 2)weeks 1 & 2; Repeat one 3-week cycle starting day 22
16371692|NCT00089024|Drug|leucovorin calcium|20 mg/m5 PO (day 1) and 20 mg/m5 IV (day 2) weeks 1 and 2; Repeat one 3-week cycle starting day 22
16371693|NCT00089024|Drug|oxaliplatin|48 mg/m5 IV over 2 hr weeks 1, 2, 4, and 5
16371849|NCT00003413|Biological|filgrastim|
16371694|NCT00089024|Procedure|adjuvant therapy|"Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. Patients will then be followed at 3 month intervals with a history and physical exam, CT scan of the chest/abdomen/pelvis, and tumor markers.
~If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression provided the patient tolerates it and wishes to remain on therapy."
16371695|NCT00089024|Procedure|conventional surgery|Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. If no contraindication for surgical resection is identified, resection will be performed six to eight weeks after completing chemoradiation. At the time of surgical resection, an extensive examination of the abdomen will be performed to exclude the presence of metastatic disease. All operations will be performed with curative intent with resection of all gross tumor (ie R0 [negative margins] or R1 [positive microscopic margins]). Resection of adjacent involved organs or vascular structures will be performed as clinically indicated.
16371696|NCT00089024|Procedure|neoadjuvant therapy|Eligible patients will receive an initial two cycles of chemotherapy with gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. A window of -2 up to +7 days will be allowed to start planned cycles of therapy provided all other criteria to restart the new cycle has been met. Patients will require a central venous catheter (Port, Hickman or Groshong catheter) for the administration of 5-FU.
16371697|NCT00089024|Radiation|radiation therapy|A re-staging CT scan, which will be obtained as part of the radiation simulation, will be used to assess any possible response to the initial two cycles of chemotherapy. Unless the patient has developed evidence of metastatic disease, chemoradiation will proceed. Patients who required no treatment delays will commence chemoradiation on day 42. If a one-week delay is needed before cycle 2 of neo-adjuvant chemotherapy can be delivered, the patient will begin chemoradiation on day 49 provided treatment-related toxicity has resolved. If cycle 2 could not be given (2 or more week delay for resolution of treatment-related toxicity), then chemoradiation will begin once toxicity has resolved (may be earlier than day 42).
16371698|NCT00089011|Drug|fludarabine phosphate|Given IV
16371699|NCT00089011|Radiation|total-body irradiation|Undergo radiotherapy
16371700|NCT00089011|Drug|mycophenolate mofetil|Given IV or PO
16371701|NCT00089011|Drug|tacrolimus|Given IV or PO
16371702|NCT00089011|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
16371703|NCT00089011|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
16371704|NCT00089011|Other|laboratory biomarker analysis|Correlative studies
16371705|NCT00088998|Biological|bevacizumab|
16371706|NCT00088998|Drug|capecitabine|
16371707|NCT00088998|Drug|docetaxel|
16371708|NCT00088985|Biological|therapeutic autologous dendritic cells|10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
16371709|NCT00088985|Biological|trastuzumab|4 mg/kg intravenously, every 14 days
16371710|NCT00088985|Drug|vinorelbine ditartrate|Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
16371711|NCT00088972|Drug|celecoxib|Given orally
16371712|NCT00088972|Other|placebo|Given orally
16371713|NCT00088959|Drug|erlotinib hydrochloride|Given orally
16371714|NCT00088959|Drug|celecoxib|Given orally
16371715|NCT00088959|Other|laboratory biomarker analysis|Correlative studies
16371716|NCT00088946|Dietary Supplement|Polyphenon E|4-200mg capsules PO daily for 12 months
16371717|NCT00088946|Drug|erlotinib hydrochloride|100 mg PO daily for 12 months
16371718|NCT00088946|Other|Erlotinib placebo|identical to Erlotinib in look and appearance of dosing.
16371719|NCT00088946|Other|Polyphenon E|identical to Polyphenon E in look and appearance of dosing.
16371720|NCT00088933|Drug|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given intradermally
16371721|NCT00088933|Drug|recombinant vaccinia-CEA(6D)-TRICOM vaccine|Given intradermally
16371722|NCT00088933|Drug|docetaxel|Given IV
16371723|NCT00088933|Drug|sargramostim|Given subcutaneously
16371724|NCT00088907|Drug|docetaxel|Given IV
16371725|NCT00088907|Other|placebo|Given orally
16371726|NCT00088907|Drug|gefitinib|Given orally
16371727|NCT00088894|Drug|gemcitabine hydrochloride|Given IV
16371728|NCT00088894|Biological|bevacizumab|Given IV
16371729|NCT00088894|Other|placebo|Given IV
16371730|NCT00088894|Other|laboratory biomarker analysis|Correlative studies
16371731|NCT00088894|Other|pharmacogenomic studies|Correlative studies
16371732|NCT00088894|Other|pharmacological study|Correlative studies
16371733|NCT00088881|Biological|rituximab|Given IV
16371734|NCT00088881|Drug|prednisone|Given orally
16371735|NCT00088881|Drug|cyclophosphamide|Given IV
16371736|NCT00088881|Drug|doxorubicin|Given IV
16371737|NCT00088881|Drug|vincristine|Given IV
16371738|NCT00088881|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
16371739|NCT00088881|Radiation|radiation therapy|Undergo radiotherapy
16371740|NCT00088881|Procedure|positron emission tomography|Undergo PET scans
16371741|NCT00088868|Drug|alvespimycin hydrochloride|
16371742|NCT00088855|Drug|Bortezomib|Given IV
16371743|NCT00088855|Other|Laboratory Biomarker Analysis|Correlative studies
16371744|NCT00088855|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16371745|NCT00088829|Drug|paclitaxel|subjects will receive paclitaxel neoadjuvantly
16371746|NCT00088829|Genetic|microarray analysis|subjects will have a biopsy to collect tissue for gene microarray analysis
16371747|NCT00088829|Procedure|biopsy|All subjects will have a biopsy to collect tissue
16371748|NCT00088829|Procedure|neoadjuvant therapy|paclitaxel is given neoadjuvantly
16371850|NCT00003413|Drug|carmustine|
16371754|NCT00088816|Procedure|neoadjuvant therapy|
16371755|NCT00088803|Genetic|molecular genetic technique|
16371756|NCT00088803|Genetic|polymerase chain reaction|
16371757|NCT00088803|Genetic|polymorphism analysis|
16371758|NCT00088790|Drug|AZD5438|
16371759|NCT00088777|Behavioral|Behavioral coping skills training plus physical therapy|10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
16371760|NCT00088777|Behavioral|Stress management education plus physical therapy|10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
16371761|NCT00088764|Behavioral|Coping skills training|8 sessions of pain and stress coping skills training
16371762|NCT00088764|Behavioral|Written emotional disclosure|4 sessions of writing about stress
16371763|NCT00088764|Behavioral|Arthritis education|8 sessions of learning about rheumatoid arthritis
16371764|NCT00088764|Behavioral|Health behavior writing|4 sessions of writing about various health behaviors
16371765|NCT00004193|Drug|ISIS 2503|
16371766|NCT00004187|Drug|capecitabine|
16371767|NCT00004187|Drug|oxaliplatin|
16371768|NCT00004186|Drug|carboplatin|
16371769|NCT00004186|Drug|etoposide|
16371770|NCT00004186|Drug|ifosfamide|
16371771|NCT00004186|Drug|topotecan hydrochloride|
16371772|NCT00004186|Radiation|radiation therapy|
16371773|NCT00004162|Biological|sargramostim|
16371774|NCT00004162|Drug|methotrexate|
16371775|NCT00004162|Drug|pegylated liposomal doxorubicin hydrochloride|
16371776|NCT00004162|Drug|vincristine sulfate|
16371777|NCT00004096|Drug|carboplatin|
16371778|NCT00004096|Drug|vinorelbine ditartrate|
16371779|NCT00004080|Biological|recombinant adenovirus-p53 SCH-58500|
16371780|NCT00004080|Procedure|conventional surgery|
16371781|NCT00004064|Biological|oregovomab|
16371782|NCT00004040|Biological|recombinant interferon alfa|
16371783|NCT00004040|Biological|rituximab|
16371784|NCT00004039|Biological|recombinant interferon alfa|
16371785|NCT00004039|Biological|rituximab|
16371786|NCT00004039|Drug|cyclophosphamide|
16371787|NCT00004039|Drug|doxorubicin hydrochloride|
16371788|NCT00004039|Drug|prednisone|
16371789|NCT00004039|Drug|vincristine sulfate|
16371790|NCT00003957|Biological|filgrastim|
16371791|NCT00003957|Biological|recombinant human stem cell factor|
16371792|NCT00003957|Drug|cyclophosphamide|
16371793|NCT00003957|Drug|cytarabine|
16371794|NCT00003957|Drug|etoposide|
16371795|NCT00003957|Drug|melphalan|
16371796|NCT00003957|Drug|mitoxantrone hydrochloride|
16371797|NCT00003957|Drug|paclitaxel|
16371798|NCT00003957|Procedure|peripheral blood stem cell transplantation|
16371799|NCT00003892|Drug|ISIS 5132|4mg/kg/day IV for 21 days every 4 weeks.
16371800|NCT00003828|Drug|vinorelbine|
16371801|NCT00003821|Drug|aminopterin|
16371802|NCT00003810|Drug|docetaxel|
16371803|NCT00003810|Drug|gemcitabine hydrochloride|
16371804|NCT00003798|Drug|motexafin gadolinium|
16371805|NCT00003798|Radiation|radiation therapy|
16371806|NCT00003786|Drug|irofulven|
16371807|NCT00003784|Drug|CHOP regimen|
16371808|NCT00003784|Drug|cyclophosphamide|
16371809|NCT00003784|Drug|doxorubicin hydrochloride|
16371810|NCT00003784|Drug|prednisone|
16371811|NCT00003784|Drug|vincristine sulfate|
16371812|NCT00003784|Radiation|tositumomab and iodine I 131 tositumomab|
16371813|NCT00003760|Drug|irofulven|Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.
16371814|NCT00003708|Drug|temozolomide|Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.
16371815|NCT00003681|Biological|epoetin alfa|
16371816|NCT00003681|Drug|amifostine trihydrate|
16371817|NCT00003663|Biological|rituximab|
16371818|NCT00003663|Drug|dexamethasone|
16371819|NCT00003662|Biological|anti-thymocyte globulin|
16371820|NCT00003662|Drug|busulfan|
16371821|NCT00003662|Drug|cyclophosphamide|
16371822|NCT00003662|Drug|cyclosporine|
16371823|NCT00003662|Drug|melphalan|
16371824|NCT00003662|Drug|methylprednisolone|
16371825|NCT00003662|Procedure|umbilical cord blood transplantation|
16371826|NCT00003662|Radiation|radiation therapy|
16371827|NCT00003661|Biological|anti-thymocyte globulin|
16371828|NCT00003661|Drug|busulfan|
16371829|NCT00003661|Drug|cyclosporine|
16371830|NCT00003661|Drug|melphalan|
16371831|NCT00003661|Drug|methylprednisolone|
16371832|NCT00003661|Procedure|umbilical cord blood transplantation|
16371833|NCT00003661|Radiation|radiation therapy|
16371834|NCT00003605|Biological|rituximab|
16371835|NCT00003605|Drug|cyclophosphamide|
16371836|NCT00003542|Biological|pegylated interferon alfa|
16371837|NCT00003539|Biological|trastuzumab|
16371838|NCT00003539|Drug|paclitaxel|
16371839|NCT00003431|Biological|recombinant flt3 ligand|
16371840|NCT00003424|Drug|tamoxifen citrate|
16371841|NCT00088673|Drug|3APS|
16371842|NCT00003416|Biological|filgrastim|
16371843|NCT00003416|Biological|recombinant interferon alfa|
16371844|NCT00003416|Drug|dexamethasone|
16371845|NCT00003416|Drug|melphalan|
16371846|NCT00003416|Procedure|peripheral blood stem cell transplantation|
16371847|NCT00003415|Drug|amifostine trihydrate|
16371848|NCT00003415|Drug|topotecan hydrochloride|
16371854|NCT00003413|Procedure|peripheral blood stem cell transplantation|
16371855|NCT00003413|Procedure|surgical procedure|
16371856|NCT00088738|Drug|[18F] SPA-RQ|
16371857|NCT00088699|Drug|Ketamine|
16371858|NCT00088699|Drug|Placebo|
16371859|NCT00088686|Drug|Capsaicin (Intramucosal Injection)|
16371860|NCT00088660|Biological|PANVAC™-VF|
16371861|NCT00088647|Drug|MST-997|
16371862|NCT00088634|Drug|Lurasidone|80 mg AM dosing once daily
16371863|NCT00088634|Drug|Placebo|Matching Placebo to 40mg lurasidone tablets
16371864|NCT00088621|Drug|Lurasidone 80mg tablet|
16371865|NCT00088608|Drug|SOM230 s.c.|
16371866|NCT00088595|Drug|Pasireotide (SOM230)|Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.
16371867|NCT00088582|Drug|Pasireotide (SOM230), Octreotide (Sandostatin)|
16371868|NCT00003358|Drug|chemotherapy|
16371869|NCT00003358|Drug|cisplatin|
16371870|NCT00003358|Drug|gemcitabine hydrochloride|
16371871|NCT00003305|Drug|aminopterin|
16371872|NCT00003305|Drug|leucovorin calcium|
16371873|NCT00003259|Drug|vinorelbine tartrate|
16371874|NCT00003256|Drug|alvocidib|
16371875|NCT00003214|Drug|carboplatin|
16371876|NCT00003214|Drug|cisplatin|
16371877|NCT00003214|Drug|cyclophosphamide|
16371878|NCT00003214|Drug|doxorubicin hydrochloride|
16371879|NCT00003214|Drug|in vitro sensitivity-directed chemotherapy|
16371880|NCT00003214|Drug|paclitaxel|
16371881|NCT00003213|Drug|dexamethasone|4 mg Dexamethasone in the morning
16371882|NCT00003213|Drug|granisetron hydrochloride|1 mg Granisetron in the morning
16371883|NCT00003213|Drug|metoclopramide hydrochloride|20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)
16371884|NCT00003182|Drug|cisplatin|
16371885|NCT00003182|Drug|gemcitabine hydrochloride|
16371886|NCT00003158|Drug|carboplatin|
16371887|NCT00003158|Drug|etoposide|
16371888|NCT00003158|Drug|paclitaxel|
16371889|NCT00003158|Radiation|radiation therapy|
16371890|NCT00003152|Biological|filgrastim|
16371891|NCT00003152|Biological|recombinant interferon alfa|
16371892|NCT00003152|Drug|cyclophosphamide|
16371893|NCT00003152|Drug|prednisone|
16371894|NCT00003152|Drug|vincristine sulfate|
16371895|NCT00003152|Procedure|autologous bone marrow transplantation|
16371896|NCT00003152|Procedure|bone marrow ablation with stem cell support|
16371897|NCT00003152|Procedure|peripheral blood stem cell transplantation|
16371898|NCT00003152|Radiation|radiation therapy|
16371899|NCT00003097|Other|preventative dietary intervention|
16371900|NCT00003090|Biological|aldesleukin|
16371901|NCT00003087|Drug|cisplatin|
16371902|NCT00003087|Drug|paclitaxel|
16371903|NCT00003087|Procedure|surgical procedure|
16371904|NCT00003087|Radiation|radiation therapy|
16371905|NCT00003068|Drug|amifostine trihydrate|
16371906|NCT00003068|Drug|cyclophosphamide|
16371907|NCT00003068|Drug|mitoxantrone hydrochloride|
16371908|NCT00003068|Drug|thiotepa|
16371909|NCT00003068|Procedure|peripheral blood stem cell transplantation|
16371910|NCT00088569|Drug|0-15 Water|
16371911|NCT00088556|Drug|TLK286|Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
16371912|NCT00088556|Drug|carboplatin|AUC 6 mg/mL/min Once every 3 weeks
16371913|NCT00088556|Drug|paclitaxel|200 mg/m² Once every 3 weeks
16371914|NCT00088543|Biological|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|total dose 4.5 mg/kg
16371915|NCT00088543|Biological|Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|total dose 8.5 mg/kg
16371916|NCT00003055|Drug|cisplatin|
16371917|NCT00003055|Drug|irinotecan hydrochloride|
16371918|NCT00003050|Drug|cyclophosphamide|
16371919|NCT00003050|Drug|doxorubicin hydrochloride|
16371920|NCT00003050|Drug|paclitaxel|
16371921|NCT00003050|Drug|tamoxifen citrate|
16371922|NCT00003050|Procedure|surgical procedure|
16371923|NCT00003050|Radiation|radiation therapy|
16371924|NCT00003002|Biological|HER-2/neu peptide vaccine|
16371925|NCT00003002|Biological|sargramostim|
16371926|NCT00003000|Drug|fentanyl citrate|
16371927|NCT00003000|Drug|morphine sulfate|
16371928|NCT00002984|Drug|cisplatin|Cisplatin will be given at a dose of 100 mg/m2 at a concentration of 1 mg/ml over one hour on Day 1 and 29 for a total of 2 courses
16371929|NCT00002984|Drug|fluorouracil|5-FU will be given at 500 mg/m2 in 1 liter D5 1/2 by continuous infusion every 12 hours for a total of 8 doses (Total 1.0 g/m2/day X 4 days) on Days 1-4 and 29-32 for a total of 2 courses
16371930|NCT00002984|Drug|paclitaxel|30 mg/m2 - 45 mg/m2 given weekly. The dose each subject receives will depend on when they enter the study
16371931|NCT00002984|Procedure|surgical procedure|Surgical resection should take place approximately 4 weeks following completion of the chemotherapy.
16371932|NCT00002984|Radiation|radiation therapy|The dose of radiation to the tumor and nodal area will be 4500 cGy given as 180 cGy fractions daily, Monday through Friday, for 5 weeks
16371933|NCT00002921|Drug|suramin|
16371934|NCT00002921|Drug|therapeutic hydrocortisone|
16371935|NCT00002833|Biological|Filgrastim|Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
16371936|NCT00002833|Drug|Cladribine|Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
16371937|NCT00002833|Drug|Cyclosporine|For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
16371997|NCT00002665|Drug|leucovorin calcium|5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC < 3,000 /μl
16371938|NCT00002833|Drug|Cytarabine (Ara-C)|Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
16371939|NCT00002833|Drug|Fludarabine Phosphate|IV over 30 minutes daily on days -6, -5, -4 and -3.
16371940|NCT00002833|Drug|Idarubicin|IV Days -6, -5 and -4.
16371941|NCT00002833|Drug|Methylprednisolone|Begins 5 days after infusion and is gradually tapered.
16371942|NCT00002833|Procedure|Peripheral Blood Stem Cell Transplantation|Cell infusion Day 0.
16371943|NCT00088530|Drug|pixantrone, cyclophosphamide, vincristine, rituximab, prednisone|Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
16371944|NCT00088530|Drug|Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab|Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
16371945|NCT00002832|Biological|Filgrastim|Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection then daily starting 1 day after PBSC infusion until blood counts recover.
16371946|NCT00002832|Drug|Cyclosporine|IV daily on day -2, then orally once dose is tolerable, dose may be escalated.
16371947|NCT00002832|Drug|Decitabine|IV for 6 hours every 12 hr for 5 days.
16371948|NCT00002832|Procedure|Allogeneic Bone Marrow Transplantation|Stem cell infusion on Day 0.
16371949|NCT00002832|Procedure|Peripheral Blood Stem Cell Transplantation|Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine.
16371950|NCT00002831|Biological|Filgrastim|Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.
16371951|NCT00002831|Drug|Busulfan|Administered orally every 6 hours on consecutive days -6 through -4.
16371952|NCT00002831|Drug|Cyclophosphamide|Given intravenously (IV) over 1 hour on consecutive days -3 and -2.
16371953|NCT00002831|Drug|Cyclosporine|Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.
16371954|NCT00002831|Drug|Decitabine (DAC)|IV over 4 hours on days -8 and -7.
16371955|NCT00002831|Drug|Methotrexate|Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.
16371956|NCT00002831|Drug|Methylprednisolone|Given according to clinical grade of GVHD procedures.
16371957|NCT00002831|Drug|Tacrolimus|IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.
16371958|NCT00002831|Procedure|Allogeneic Bone Marrow Transplantation|Infusion of stem cells on Day 0.
16371959|NCT00002831|Procedure|Peripheral Blood Stem Cell Transplantation|Stem cell infusion on Day 0.
16371960|NCT00002824|Biological|gene therapy|
16371961|NCT00002824|Drug|chemotherapy|
16371962|NCT00002824|Drug|ganciclovir|
16371963|NCT00002824|Procedure|conventional surgery|
16371964|NCT00002784|Biological|filgrastim|Filgrastim 10 mg/kg/d sc for 6 days after randomization.
16371965|NCT00002784|Drug|CMF regimen|Cyclophosphamide 100 mg/m2 orally days 1 - 14, methotrexate 40 mg/m2 iv days 1 and 8, 5-fluorouracil 600 mg/m2 iv days 1 and 8. Repeat every 28 days.
16371966|NCT00002784|Drug|cyclophosphamide|For high-dose EC arm: cyclophosphamide 4 gm/m2 iv as 4 divided doses. For standard chemotherapy arm: cyclophosphamide 600 mg/m2 iv day 1 of 21-day EC cycles, and cyclophosphamide 100 mg/m2 orally on days 1-14 of 28-day CMF cycles.
16371967|NCT00002784|Drug|doxorubicin hydrochloride|Doxorubicin 60 mg/m2 iv on day 1 of 21-day cycles of AC.
16371968|NCT00002784|Drug|epirubicin hydrochloride|Epirubicin 90 mg/m2 iv on day 1 of 21-day cycles of EC.
16371969|NCT00002784|Drug|fluorouracil|5-fluorouracil 600 mg/m2 iv days 1 and 8 of 28-day cycles of CMF.
16371970|NCT00002784|Drug|mesna|MESNA (7.2 gm/m2) on days 2 and 3 of 21-day cycles of dose-intensive EC.
16371971|NCT00002784|Drug|methotrexate|Methotrexate 40 mg/m2 iv on days 1 and 8 of 28-day cycles of CMF.
16371972|NCT00002784|Drug|tamoxifen citrate|Tamoxifen 20mg daily for 5 years or until relapse.
16371973|NCT00002784|Procedure|peripheral blood stem cell transplantation|Peripheral blood progenitor cells (PBPC) infusion on day 5 of each 21-day cycle of dose-intensive EC.
16371974|NCT00002784|Radiation|low-LET electron therapy|Radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.
16371975|NCT00002784|Radiation|low-LET photon therapy|radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.
16371976|NCT00002779|Drug|fludarabine phosphate|
16371977|NCT00002779|Drug|octreotide acetate|
16371978|NCT00002754|Biological|monoclonal antibody Me1-14 F(ab')2|
16371979|NCT00002753|Radiation|iodine I 131 monoclonal antibody 81C6|
16371980|NCT00002688|Drug|cyclosporine|
16371981|NCT00002688|Drug|etoposide|
16371982|NCT00002688|Drug|mitoxantrone hydrochloride|
16371983|NCT00002675|Biological|filgrastim|
16371984|NCT00002675|Drug|carboplatin|
16371985|NCT00002675|Drug|cisplatin|
16371986|NCT00002675|Drug|cyclophosphamide|
16371987|NCT00002675|Drug|etoposide|
16371988|NCT00002675|Drug|mesna|
16371989|NCT00002675|Drug|vincristine sulfate|
16371990|NCT00002665|Drug|asparaginase|10,000 units/d IV or IM 15 - 24
16371991|NCT00002665|Drug|cyclophosphamide|con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1
16371992|NCT00002665|Drug|cytarabine|cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26
16371993|NCT00002665|Drug|daunorubicin hydrochloride|ind: 60 mg/m2 IV 22 and 23
16371994|NCT00002665|Drug|dexamethasone|main: 10 mg/m2/day PO 1 - 28
16371995|NCT00002665|Drug|doxorubicin hydrochloride|main: 25 mg/m2 IV 1, 8, 15, and 22
16371996|NCT00002665|Drug|etoposide|60 mg/kg based on ideal body weight day -3
16371998|NCT00002665|Drug|mercaptopurine|con: 60 mg/m2 PO 1 - 28
16371999|NCT00002665|Drug|methotrexate|10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin
16372000|NCT00002665|Drug|prednisone|"ind: 60 mg/m2/d PO 1 - 21*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42.
~ind2: 60 mg/m2/d PO through day 42"
16372001|NCT00002665|Drug|thioguanine|main: 60 mg/m2/day PO 1 - 14
16372002|NCT00002665|Drug|vincristine sulfate|ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22
16372003|NCT00002665|Procedure|allogeneic bone marrow transplantation|day 0
16372004|NCT00002665|Radiation|radiation therapy|day -7 through day -4 total dose of radiation is 1,320 cGy.
16372005|NCT00002630|Biological|filgrastim|
16372006|NCT00002630|Drug|cyclophosphamide|
16372007|NCT00002630|Drug|melphalan|
16372008|NCT00002630|Procedure|peripheral blood stem cell transplantation|
16372009|NCT00002630|Radiation|low-LET cobalt-60 gamma ray therapy|
16372010|NCT00002630|Radiation|low-LET photon therapy|
16372011|NCT00002627|Biological|filgrastim|
16372012|NCT00002627|Drug|carboplatin|
16372013|NCT00002627|Drug|cyclophosphamide|
16372014|NCT00002627|Drug|mesna|
16372015|NCT00002627|Drug|paclitaxel|
16372016|NCT00002627|Procedure|peripheral blood stem cell transplantation|
16372017|NCT00002618|Biological|filgrastim|
16372018|NCT00002618|Drug|cytarabine|
16372019|NCT00002618|Drug|doxorubicin hydrochloride|
16372020|NCT00002618|Drug|leucovorin calcium|
16372021|NCT00002618|Drug|mercaptopurine|
16372022|NCT00002618|Drug|methotrexate|
16372023|NCT00002618|Drug|prednisone|
16372024|NCT00002618|Drug|vincristine sulfate|
16372025|NCT00002618|Radiation|low-LET cobalt-60 gamma ray therapy|
16372026|NCT00002618|Radiation|low-LET electron therapy|
16372027|NCT00002618|Radiation|low-LET photon therapy|
16372028|NCT00002604|Drug|O6-benzylguanine|Patients receive BG IV over 1 hour during week 1, and then BG IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
16372029|NCT00002604|Drug|carmustine|After one hour of receiving BG patients receive BCNU IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
16372030|NCT00002604|Drug|chemosensitization/potentiation therapy|
16372031|NCT00002588|Drug|etoposide|
16372032|NCT00002588|Drug|topotecan hydrochloride|
16372033|NCT00002572|Biological|aldesleukin|
16372034|NCT00002572|Biological|muromonab-CD3|
16372035|NCT00002572|Biological|therapeutic tumor infiltrating lymphocytes|
16372036|NCT00002572|Procedure|conventional surgery|
16372037|NCT00002542|Drug|CMF regimen|
16372038|NCT00002542|Drug|cyclophosphamide|
16372039|NCT00002542|Drug|doxorubicin hydrochloride|
16372040|NCT00002542|Drug|epirubicin hydrochloride|
16372041|NCT00002542|Drug|fluorouracil|
16372042|NCT00002542|Drug|methotrexate|
16372043|NCT00002542|Drug|tamoxifen citrate|
16372044|NCT00002542|Radiation|radiation therapy|
16372045|NCT00002535|Biological|aldesleukin|
16372046|NCT00002535|Biological|lymphokine-activated killer cells|
16372047|NCT00002535|Biological|therapeutic tumor infiltrating lymphocytes|
16372048|NCT00002535|Drug|cyclophosphamide|
16372049|NCT00002535|Drug|indomethacin|
16372050|NCT00002529|Drug|cyclophosphamide|cyclophosphamide 600 mg/m2 i.v. day 1) every 21 days
16372051|NCT00002529|Drug|doxorubicin hydrochloride|doxorubicin 60 mg/m2 i.v. day 1) every 21 days, intravenous.
16372052|NCT00002529|Drug|epirubicin hydrochloride|epirubicin 90 mg/m2 i.v. day 1) every 21 days, intravenous.
16372053|NCT00002529|Drug|tamoxifen citrate|Tamoxifen 20 mg daily.
16372054|NCT00002529|Drug|toremifene|Toremifene 60 mg daily.
16372055|NCT00088517|Drug|[11C]NNC-112|
16372056|NCT00088504|Drug|Merimepodib|
16372057|NCT00088504|Drug|PEG-Interferon-alpha 2a (Pegasys®)|
16372058|NCT00088504|Drug|Ribavirin (Copegus®)|
16372059|NCT00088491|Drug|Intramuscular Olanzapine Depot|
16372060|NCT00088491|Drug|Oral Olanzapine|
16372061|NCT00088478|Drug|Intramuscular Olanzapine Depot|
16372062|NCT00088478|Drug|Placebo|
16372063|NCT00088465|Drug|Intramuscular olanzapine depot|45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
16372064|NCT00088452|Drug|Ethosuximide|Ethosuximide is a common treatment for childhood absence epilepsy.
16372065|NCT00088452|Drug|Lamotrigine|Lamotrigine is a common treatment for childhood absence epilepsy.
16372066|NCT00088452|Drug|Valproic acid|Valproic acid is a common treatment for childhood absence epilepsy.
16372067|NCT00088413|Biological|PANVAC-V|Patients receive 2 x 10(8) pfu PANVAC-V (vaccinia) subcutaneously on Day 1.
16372068|NCT00088413|Biological|PANVAC-F|Patients receive 1 x 10(9) pfu PANVAC-F (fowlpox) or about days 15, 29, and 43 then every month for 12 doses then every 3 months until disease progression or toxicity.
16372069|NCT00088413|Drug|Sargramostim (GM-CSF, Leukine)|100g sargramostim will be given subcutaneously at the site of the vaccination on each vaccination day and for three consecutive days thereafter.
16372070|NCT00088400|Drug|TransMID|
16372071|NCT00088387|Drug|Divalproex|
16372072|NCT00088387|Drug|Lithium|
16372073|NCT00088374|Drug|17 allylamino-17-demethoxygeldanamycin|17 allylamino-17-demethoxygeldanamycin (17 AAG) given intravenously at a dose of 300 mg/m2 on days 1,8 and 15 of 28 day cycles.
16372074|NCT00088374|Drug|18 FDG (Fludeoxyglucose 18F)|18FDG PET performed at baseline and 12 weeks after treatment. At each timepoint participants can receive 250mCi 0-15 water and 15 mCi F18-FDG.
16372075|NCT00088374|Drug|[15-O] H2O|[15-0] H20 performed at baseline and 12 weeks after treatment. At each time point participants can receive 250mCi 0-15 water and 15 mCi F18-FDG. The water scans were done as several intravenous injections for several scans but not over a total of 250 mCi.
16372159|NCT00088179|Drug|pexelizumab in conjunction with CABG|
16372160|NCT00087997|Drug|STA-4783|
16372076|NCT00088374|Drug|EPL diluent|17AAG is formulated with this diluent. Supplied in a 50 mL flint vial containing 48 mL of 2% egg phospholipids, and 5% dextrose in Water for Injection, USP. Patients with a history of serious allergic reactions to eggs should not receive this agent.
16372077|NCT00088309|Procedure|Eye exam|
16372078|NCT00088309|Procedure|Oral exam|
16372079|NCT00088309|Procedure|CT scan|
16372080|NCT00088309|Procedure|Neuropsychological testing|
16372081|NCT00088309|Procedure|Electrocardiogram|
16372082|NCT00088309|Procedure|Echocardiogram|
16372083|NCT00088296|Procedure|Blood Draw|
16372084|NCT00088283|Drug|pegaptanib sodium|
16372085|NCT00088270|Drug|OSI-7904L|
16372086|NCT00088270|Drug|5-Fluorouracil/Leucovorin|
16372087|NCT00005884|Drug|eflornithine|
16372088|NCT00005852|Biological|anti-thymocyte globulin|
16372089|NCT00005852|Biological|filgrastim|
16372090|NCT00005852|Biological|muromonab-CD3|
16372091|NCT00005852|Drug|cyclophosphamide|
16372092|NCT00005852|Drug|cyclosporine|
16372093|NCT00005852|Drug|methylprednisolone|
16372094|NCT00005852|Procedure|allogeneic bone marrow transplantation|
16372095|NCT00005805|Dietary Supplement|St. John's wort|
16372096|NCT00005633|Biological|OVA BiP peptide|
16372097|NCT00005633|Biological|gp209-2M antigen|
16372098|NCT00005633|Biological|recombinant 70-kD heat-shock protein|
16372099|NCT00005633|Biological|tyrosinase peptide|
16372100|NCT00005624|Drug|CI-994|CI-994 as outlined in treatment arm.
16372101|NCT00005614|Drug|Gemcitabine hydrochloride|Gemcitabine via IV
16372102|NCT00005611|Drug|BMS-188797|
16372103|NCT00004902|Drug|tocladesine|
16372104|NCT00004901|Drug|ethynyluracil|
16372105|NCT00004901|Drug|fluorouracil|
16372106|NCT00004901|Drug|hydroxyurea|
16372107|NCT00004901|Radiation|radiation therapy|
16372108|NCT00004897|Biological|recombinant interferon alfa|
16372109|NCT00004897|Drug|cisplatin|
16372110|NCT00004897|Drug|fluorouracil|
16372111|NCT00004897|Drug|hydroxyurea|
16372112|NCT00004897|Drug|leucovorin calcium|
16372113|NCT00004897|Procedure|conventional surgery|
16372114|NCT00004897|Radiation|radiation therapy|
16372115|NCT00004875|Drug|enoxaparin|
16372116|NCT00004875|Drug|heparin|
16372117|NCT00004265|Drug|paclitaxel|
16372118|NCT00004264|Drug|amifostine trihydrate|
16372119|NCT00004264|Drug|cisplatin|
16372120|NCT00004264|Drug|docetaxel|
16372121|NCT00004263|Drug|7-hydroxystaurosporine (UCN-01)|20 mg/m2 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses. Treatment repeats every 4 weeks for a maximum of 4 courses.
16372122|NCT00004263|Drug|Cytarabine (Ara-C)|Starting dose 1 g/m2 IV over 24 hours on days 1-4 of each course. Treatment repeats every 4 weeks for a maximum of 4 courses.
16372123|NCT00004258|Drug|cilengitide|dose escalation of cilengitide
16372124|NCT00004169|Drug|carboplatin|
16372125|NCT00004169|Drug|cyclophosphamide|
16372126|NCT00004169|Drug|etoposide|
16372127|NCT00004169|Procedure|peripheral blood stem cell transplantation|
16372128|NCT00004169|Radiation|radiation therapy|
16372129|NCT00004159|Drug|gemcitabine hydrochloride|
16372130|NCT00004159|Drug|paclitaxel|
16372131|NCT00003942|Biological|RevM10 gene|
16372132|NCT00003942|Biological|RevM10/polAS gene|
16372133|NCT00003942|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372134|NCT00003942|Procedure|peripheral blood stem cell transplantation|
16372135|NCT00003936|Drug|bryostatin 1|
16372136|NCT00003929|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously daily on days 12-21 and days 33-42, until absolute neutrophil counts recover. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
16372137|NCT00003929|Drug|lomustine|Oral lomustine on day 1. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
16372138|NCT00003929|Drug|procarbazine hydrochloride|Oral procarbazine on days 1-10 and days 22-31. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
16372139|NCT00003929|Radiation|radiation therapy|Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy.
16372140|NCT00002506|Biological|recombinant interferon alfa|
16372141|NCT00002506|Drug|isotretinoin|
16372142|NCT00002504|Biological|aldesleukin|
16372143|NCT00002504|Biological|recombinant interferon alfa|
16372144|NCT00002462|Biological|bleomycin sulfate|
16372145|NCT00002462|Drug|doxorubicin hydrochloride|
16372146|NCT00002462|Drug|mechlorethamine hydrochloride|
16372147|NCT00002462|Drug|prednisone|
16372148|NCT00002462|Drug|procarbazine hydrochloride|
16372149|NCT00002462|Drug|vinblastine sulfate|
16372150|NCT00002462|Drug|vincristine sulfate|
16372151|NCT00002462|Radiation|low-LET cobalt-60 gamma ray therapy|
16372152|NCT00002462|Radiation|low-LET photon therapy|
16372153|NCT00002462|Radiation|radiation therapy|
16372154|NCT00088231|Drug|Imatinib Mesylate (Gleevec)|"600 mg by mouth every day (for AML, CML-BP) for a 28 day cycle.
~400 mg by mouth every day (for AMM) for a 28 day cycle."
16372155|NCT00088231|Drug|PTK 787 (vatalanib)|"For 1 week prior to receipt of the study combination regimen, all patients will receive single agent PTK 787 at the dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels.
~Starting dose: 250 mg by mouth every day for a 28 day cycle."
16372156|NCT00088218|Drug|Clofarabine|1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
16372157|NCT00088218|Drug|Ara-C|20 mg/m^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).
16372158|NCT00088205|Drug|enzastaurin|500 milligrams (mg), oral, daily, up to six 28-day cycles
16372161|NCT00088192|Drug|pegaptanib sodium|
16372162|NCT00088166|Drug|hCRF|hCRF ; open-label dexamethasone that the patient is currently taking
16372163|NCT00088166|Drug|placebo hCRF|placebo hCRF 2mg/day and open-label dexamethasone that they are taking
16372164|NCT00003884|Drug|zoledronic acid|
16372165|NCT00003884|Procedure|quality-of-life assessment|
16372166|NCT00003812|Biological|filgrastim|
16372167|NCT00003812|Drug|carboplatin|
16372168|NCT00003812|Drug|etoposide|
16372169|NCT00003812|Drug|paclitaxel|
16372170|NCT00003812|Drug|topotecan hydrochloride|
16372171|NCT00003812|Radiation|radiation therapy|
16372172|NCT00003808|Drug|theophylline|
16372173|NCT00003781|Drug|docetaxel|
16372174|NCT00003781|Procedure|pain therapy|
16372175|NCT00003781|Procedure|quality-of-life assessment|
16372176|NCT00003763|Procedure|radionuclide imaging|
16372177|NCT00003763|Radiation|indium In 111 folic acid|
16372178|NCT00003748|Drug|irinotecan hydrochloride|One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.
16372179|NCT00003725|Drug|valrubicin|
16372180|NCT00003725|Procedure|conventional surgery|
16372181|NCT00003677|Drug|Dolastatin 10|IV bolus once every 21 days.
16372182|NCT00003675|Drug|topotecan hydrochloride|1.2 mg/sq m twice a day for 5 days (Arm I) and once a day for 10 days (Arm II)
16372183|NCT00003610|Dietary Supplement|capsaicin|
16372184|NCT00003610|Other|placebo|
16372185|NCT00003610|Radiation|radiation therapy|
16372186|NCT00003585|Biological|aldesleukin|
16372187|NCT00003585|Biological|recombinant interferon alfa|
16372188|NCT00003585|Drug|fluorouracil|
16372189|NCT00003585|Drug|isotretinoin|
16372190|NCT00003585|Procedure|surgical procedure|
16372191|NCT00003557|Drug|dolastatin 10|
16372192|NCT00003392|Biological|filgrastim|10 mcg/kg/d, day 2 through last day of leukapheresis
16372193|NCT00003392|Drug|carboplatin|18 AUC IV, approximately days 21, 42
16372194|NCT00003392|Drug|cyclophosphamide|4 gm/m2 IV, day 1
16372195|NCT00003392|Drug|melphalan|140 mg/m2 IV , approximately day 63
16372196|NCT00003392|Drug|paclitaxel|170 mg/m2 IV day 1
16372197|NCT00003392|Procedure|bone marrow ablation with stem cell support|
16372198|NCT00003392|Procedure|peripheral blood stem cell transplantation|
16372199|NCT00003391|Biological|monoclonal antibody muJ591|
16372200|NCT00003267|Procedure|infection prophylaxis and management|
16372201|NCT00003267|Procedure|management of therapy complications|
16372202|NCT00003267|Procedure|surgical procedure|
16372203|NCT00088153|Drug|Physiologic Estrogen/progesterone|Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month
16372204|NCT00088153|Other|Placebo|Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month
16372205|NCT00088140|Drug|IDN-6556|
16372206|NCT00088140|Drug|Placebo|
16372207|NCT00088114|Drug|STA-4783/paclitaxel|
16372208|NCT00088101|Drug|STA-5312|
16372209|NCT00088088|Drug|Paclitaxel|
16372210|NCT00088088|Drug|Carboplatin|
16372211|NCT00088088|Drug|STA 4783|
16372212|NCT00088075|Drug|Risperidone|
16372213|NCT00088062|Drug|STA-5326|
16372214|NCT00088049|Drug|Olanzapine|
16372215|NCT00088049|Drug|Aripiprazole|
16372216|NCT00088036|Drug|Olanzapine|
16372217|NCT00003238|Drug|perillyl alcohol|
16372218|NCT00003225|Drug|amifostine trihydrate|Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
16372219|NCT00003225|Drug|irinotecan hydrochloride|"10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
~Administered every 14 days for 3 cycles"
16372220|NCT00088023|Drug|PT-523 for Injection|
16372221|NCT00088010|Drug|Arzoxifene|20mg, oral, tablet, once a day for 36 months
16372222|NCT00088010|Drug|Placebo|oral, tablet, once a day for 36 months
16372223|NCT00087984|Biological|MB-002|Dendritic Cell Immunotherapy
16372224|NCT00087958|Drug|XRP9881|
16372225|NCT00087945|Drug|Abacavir sulfate|
16372226|NCT00087945|Drug|Abacavir sulfate, lamivudine, and zidovudine|
16372227|NCT00087880|Drug|Bupropion and NRT|All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
16372228|NCT00087867|Drug|SCIO-469|two 30-mg capsules three times daily
16372229|NCT00087867|Drug|SCIO-469 and bortezomib|In addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period
16372230|NCT00005996|Drug|cisplatin|
16372231|NCT00005996|Drug|gemcitabine hydrochloride|
16372232|NCT00005996|Drug|semaxanib|
16372233|NCT00005806|Drug|carboplatin|
16372234|NCT00005806|Drug|gefitinib|
16372235|NCT00005806|Drug|paclitaxel|
16372236|NCT00005632|Biological|MUC1-KLH vaccine/QS21|
16372237|NCT00005619|Genetic|polymerase chain reaction|
16372238|NCT00005619|Other|flow cytometry|
16372239|NCT00005619|Other|immunohistochemistry staining method|
16372240|NCT00005042|Drug|semaxanib|
16372241|NCT00005029|Drug|topotecan hydrochloride|
16372242|NCT00004199|Drug|cisplatin|
16372243|NCT00004199|Drug|gemcitabine hydrochloride|
16372244|NCT00004199|Drug|prinomastat|
16372245|NCT00004164|Biological|filgrastim|
16372246|NCT00004164|Drug|cisplatin|
16372247|NCT00004164|Drug|docetaxel|
16372248|NCT00004164|Drug|fluorouracil|
16372249|NCT00004164|Drug|leucovorin calcium|
16372250|NCT00004164|Radiation|radiation therapy|
16372252|NCT00004160|Drug|gemcitabine hydrochloride|
16372253|NCT00004160|Drug|paclitaxel|
16372254|NCT00004160|Radiation|radiation therapy|
16372255|NCT00004158|Drug|melphalan|
16372256|NCT00004158|Procedure|peripheral blood stem cell transplantation|
16372257|NCT00004158|Radiation|holmium Ho 166 DOTMP|
16372258|NCT00004104|Biological|liposomal interleukin-2|
16372259|NCT00004104|Biological|polyvalent melanoma vaccine|
16372260|NCT00004104|Biological|recombinant interferon alfa|
16372261|NCT00004060|Drug|exatecan mesylate|
16372262|NCT00004047|Drug|exatecan mesylate|
16372263|NCT00004041|Biological|Ad5CMV-p53 gene|
16372264|NCT00004041|Procedure|conventional surgery|
16372265|NCT00003881|Biological|trastuzumab|
16372266|NCT00003881|Drug|carboplatin|
16372267|NCT00003881|Drug|paclitaxel|
16372268|NCT00003219|Drug|perillyl alcohol|
16372269|NCT00003196|Drug|chemotherapy|Undergo cytoreductive chemotherapy
16372270|NCT00003196|Radiation|total-body irradiation|Undergo TBI
16372271|NCT00003196|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
16372272|NCT00003196|Drug|cyclosporine|Given IV or PO
16372273|NCT00003196|Drug|mycophenolate mofetil|Given PO
16372274|NCT00003196|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplant
16372275|NCT00003196|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
16372276|NCT00003171|Drug|bryostatin 1|
16372277|NCT00003082|Biological|monoclonal antibody A27.15|
16372278|NCT00003082|Biological|monoclonal antibody E2.3|
16372279|NCT00003057|Drug|loperamide hydrochloride|
16372280|NCT00003057|Drug|octreotide acetate|
16372281|NCT00002998|Drug|cisplatin|
16372282|NCT00002998|Drug|gemcitabine hydrochloride|
16372283|NCT00002994|Biological|interleukin 2|low dose: 1 million IU/square meter subq injection q day days 1-7 and 11-20 cycle 1; days 4-14 subsequent cycles Intermediate dose: 12 million IU/square meter subq injection on days 8-10 of cycle 1; days 1-3 of subsequent cycles
16372284|NCT00002994|Biological|rhuMAb|90 min IV infusion day 7 of each cycle
16372285|NCT00002956|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
16372286|NCT00002925|Drug|ara-C|
16372287|NCT00002925|Drug|Daunorubicin|
16372288|NCT00002925|Drug|Etoposide|
16372289|NCT00002925|Drug|PSC-833|
16372290|NCT00002925|Biological|Aldesleukin|
16372291|NCT00002908|Drug|bryostatin 1|
16372292|NCT00002908|Drug|vincristine sulfate|
16372293|NCT00002907|Drug|bryostatin 1|
16372294|NCT00002862|Drug|perillyl alcohol|
16372295|NCT00002763|Biological|recombinant interferon alfa|
16372296|NCT00002760|Drug|ketoconazole|400 mg PO tid for as long as treatment is effective
16372297|NCT00002760|Drug|therapeutic hydrocortisone|hydrocortisone 30 mg PO q am and 10 mg PO qhs for as long as treatment is effective
16372298|NCT00002760|Other|Withdrawal of antiandrogen therapy|no drugs given
16372299|NCT00002667|Other|cytology specimen collection procedure|
16372300|NCT00002667|Other|immunoenzyme technique|
16372301|NCT00002667|Procedure|study of high risk factors|
16372302|NCT00002620|Drug|carmustine|
16372303|NCT00002620|Drug|chemotherapy|
16372304|NCT00002620|Drug|mitolactol|
16372305|NCT00002620|Radiation|low-LET cobalt-60 gamma ray therapy|
16372306|NCT00002620|Radiation|low-LET photon therapy|
16372307|NCT00002563|Procedure|psychosocial assessment and care|Evaluate psychosocial function at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
16372308|NCT00002563|Procedure|quality-of-life assessment|Evaluate quality of life at prestudy, 6 months after starting treatment on S9133, and annually at 1-7 years after starting treatment on S9133.
16372309|NCT00002557|Drug|CHOP regimen|
16372310|NCT00002557|Drug|doxorubicin hydrochloride|
16372311|NCT00002557|Drug|etoposide|
16372312|NCT00002557|Drug|leucovorin calcium|
16372313|NCT00002557|Drug|methotrexate|
16372314|NCT00002549|Biological|filgrastim|
16372315|NCT00002549|Drug|busulfan|
16372316|NCT00002549|Drug|cyclophosphamide|
16372317|NCT00002549|Drug|cytarabine|
16372318|NCT00002549|Drug|daunorubicin hydrochloride|
16372319|NCT00002549|Drug|etoposide|
16372320|NCT00002549|Drug|idarubicin|
16372321|NCT00002549|Drug|mesna|
16372322|NCT00002549|Drug|mitoxantrone hydrochloride|
16372323|NCT00002549|Procedure|allogeneic bone marrow transplantation|
16372324|NCT00002549|Procedure|autologous bone marrow transplantation|
16372325|NCT00002549|Procedure|peripheral blood stem cell transplantation|
16372326|NCT00002549|Radiation|radiation therapy|
16372327|NCT00002545|Drug|carmustine|
16372328|NCT00002545|Radiation|low-LET photon therapy|
16372329|NCT00002502|Drug|busulfan|
16372330|NCT00002502|Drug|cyclophosphamide|
16372331|NCT00002502|Drug|cytarabine|
16372332|NCT00002502|Procedure|allogeneic bone marrow transplantation|
16372333|NCT00002495|Drug|doxorubicin hydrochloride|25 mg/m^2 on days 1 and 15
16372334|NCT00002495|Drug|vinblastine|6 mg/m^2 on days 1 and 15
16372335|NCT00002495|Radiation|standard subtotal nodal irradiation|3600-4000 cGy delivered over 20 fractions
16372336|NCT00002465|Drug|megestrol acetate|
16372337|NCT00087854|Drug|Amonafide L-malate (drug)|
16372338|NCT00087841|Behavioral|Self-hypnotic relaxation|
16372339|NCT00087828|Drug|Cranberry juice cocktail|
16372340|NCT00087815|Drug|dexamethasone|
16372341|NCT00087815|Drug|hyperbaric oxygen|
16372342|NCT00087815|Procedure|cognitive assessment|
16372343|NCT00087815|Procedure|magnetic resonance imaging|
16372344|NCT00087815|Procedure|positron emission tomography|
16372345|NCT00087815|Procedure|quality-of-life assessment|
16372575|NCT00086606|Drug|Xolair (omalizumab)|
16372346|NCT00087802|Drug|gemcitabine/Eloxatin (GEMOX)|GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]
16372347|NCT00087802|Drug|carboplatin/paclitaxel (CP)|"CP [carboplatin/paclitaxel - 21 day cycle]
~o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]"
16372348|NCT00087789|Genetic|CERE-110: Adeno-Associated Virus Delivery of NGF|CERE-110 2.0 x 10^10 vg, CERE-110 1.0 x 10^11 vg, CERE-110 2.0 x 10^11 vg
16372349|NCT00087776|Drug|Chemotherapy|
16372350|NCT00087763|Drug|Macugen ™ (pegaptanib sodium injection)|
16372351|NCT00087750|Drug|Quetiapine|
16372352|NCT00087737|Drug|DVS-233 SR|
16372353|NCT00087737|Drug|Venlafaxine ER|
16372354|NCT00087711|Drug|pemetrexed|500 mg/m2, IV q 21 days x 6 cycles
16372355|NCT00087711|Drug|gemcitabine|1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
16372356|NCT00087711|Drug|cisplatin|75 mg/m2, IV, q 21 days x 6 cycles
16372357|NCT00087698|Drug|pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 4 cycles
16372358|NCT00087698|Drug|cisplatin|75 mg/m2, intravenous (IV), every 21 days x 4 cycles
16372359|NCT00082511|Drug|Prasterone (GL701)|"There were 4 arms to the study:
~During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study."
16372360|NCT00003877|Biological|filgrastim|
16372361|NCT00003877|Drug|carboplatin|
16372362|NCT00003877|Drug|cyclophosphamide|
16372363|NCT00003877|Drug|paclitaxel|
16372364|NCT00003877|Drug|thiotepa|
16372365|NCT00003877|Procedure|in vitro-treated bone marrow transplantation|
16372366|NCT00003877|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372367|NCT00003874|Biological|monoclonal antibody CD19|
16372368|NCT00003874|Biological|monoclonal antibody CD20|
16372369|NCT00003874|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372370|NCT00003873|Drug|fluorouracil|Given IV or orally
16372371|NCT00003873|Drug|eniluracil|Given orally
16372372|NCT00003853|Drug|4'-iodo-4'-deoxydoxorubicin|
16372373|NCT00003805|Drug|piperacillin sodium|
16372374|NCT00003805|Drug|piperacillin-tazobactam|
16372375|NCT00003805|Drug|tazobactam sodium|
16372376|NCT00003805|Drug|vancomycin|
16372377|NCT00003804|Biological|dactinomycin|
16372378|NCT00003804|Drug|vincristine sulfate|
16372379|NCT00003804|Procedure|conventional surgery|
16372380|NCT00003792|Biological|MART-1 antigen|
16372381|NCT00003792|Biological|filgrastim|
16372382|NCT00003792|Biological|flu matrix peptide p58-66|
16372383|NCT00003792|Biological|gp100 antigen|
16372384|NCT00003792|Biological|recombinant MAGE-3.1 antigen|
16372385|NCT00003792|Biological|tyrosinase peptide|
16372386|NCT00003792|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372387|NCT00003743|Biological|aldesleukin|
16372388|NCT00003664|Biological|aldesleukin|
16372389|NCT00003664|Biological|recombinant interferon alfa|
16372390|NCT00003664|Drug|fluorouracil|
16372391|NCT00003664|Drug|gemcitabine hydrochloride|
16372392|NCT00003639|Biological|recombinant interferon alfa|
16372393|NCT00003639|Drug|chlorambucil|
16372394|NCT00003639|Drug|dexamethasone|
16372395|NCT00003639|Drug|idarubicin|
16372396|NCT00003604|Biological|aldesleukin|
16372397|NCT00003359|Drug|batabulin sodium|
16372398|NCT00003343|Drug|endocrine-modulating drug therapy|
16372399|NCT00003343|Drug|mitoxantrone hydrochloride|
16372400|NCT00003343|Drug|prednisone|
16372401|NCT00003343|Drug|prinomastat|
16372402|NCT00003328|Drug|porfiromycin|
16372403|NCT00003328|Radiation|radiation therapy|
16372404|NCT00087724|Drug|FK962|
16372405|NCT00087685|Drug|RAD001|10 mg by mouth Daily
16372406|NCT00087672|Drug|CC-5013|10 mg orally (2 capsules) daily
16372407|NCT00087659|Drug|zoledronic acid|
16372408|NCT00087646|Drug|Ribavirin|1000/1200mg po daily for 72 weeks
16372409|NCT00087646|Drug|Ribavirin|1000/1200mg po daily for 48 weeks
16372410|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
16372411|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
16372412|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 72 weeks
16372413|NCT00087646|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 48 weeks
16372414|NCT00087633|Drug|peginterferon alfa-2a [Pegasys]|135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
16372415|NCT00087633|Drug|Copegus|400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
16372416|NCT00087620|Drug|XELODA [capecitabine]|
16372417|NCT00087607|Drug|Ribavirin|1000/1200mg/day po
16372418|NCT00087607|Drug|Peginterferon alfa-2b (PEG-Intron)|1.5 micrograms/kg sc weekly
16372419|NCT00087607|Drug|Ribavirin|1000/1200mg/day po
16372420|NCT00087607|Drug|Peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly
16372421|NCT00087594|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
16372422|NCT00087594|Drug|ribavirin|1000/1200mg (< or >= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
16372491|NCT00087178|Drug|epirubicin|epirubicin 100 mg/m2 IV every 21 days for 6 cycles
16372492|NCT00087178|Drug|fluorouracil|fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
16372423|NCT00087581|Drug|Mycophenolate mofetil|Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity.
16372424|NCT00087581|Drug|Cyclosporine|Cyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full).
16372425|NCT00087581|Drug|Tacrolimus|Tacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full).
16372426|NCT00087568|Drug|Ribavirin|1000/1200mg po bid for 36 or 60 weeks
16372427|NCT00087568|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
16372428|NCT00087555|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
16372429|NCT00087555|Drug|Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
16372430|NCT00087555|Drug|Placebo|Placebo one of two doses matching active treatment by volume for 8 weeks.
16372431|NCT00087542|Drug|ACP-103|
16372432|NCT00087529|Drug|placebo|Intravenous repeating dose
16372433|NCT00087529|Drug|rituximab|Intravenous repeating dose
16372434|NCT00087516|Drug|Sitagliptin (MK0431)|Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
16372435|NCT00087516|Drug|Sitagliptin|Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
16372436|NCT00087516|Drug|Placebo|Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
16372437|NCT00087516|Drug|Placebo|Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
16372438|NCT00087516|Drug|Metformin - Rescue|Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
16372439|NCT00087503|Drug|Edotecarin|
16372440|NCT00087490|Drug|linezolid|
16372441|NCT00087490|Drug|vancomycin|
16372442|NCT00087477|Drug|Pivanex|
16372443|NCT00087464|Drug|Emtricitabine|
16372444|NCT00087464|Drug|Nevirapine|
16372445|NCT00087464|Drug|Tenofovir disoproxil fumarate|
16372446|NCT00087451|Drug|AP23573|ridaforolimus
16372447|NCT00086710|Drug|Fuzeon|
16372448|NCT00086645|Drug|citalopram hydrobromide|10mg/5ml solution
16372449|NCT00086645|Other|placebo|up to equivalent of 20 mg of active comparator daily
16372450|NCT00003589|Drug|cisplatin|
16372451|NCT00003589|Drug|gemcitabine hydrochloride|
16372452|NCT00003589|Drug|paclitaxel|
16372453|NCT00087438|Radiation|stereotactic body radiation therapy|
16372454|NCT00087425|Biological|rituximab|
16372455|NCT00087425|Drug|bryostatin 1|
16372456|NCT00087412|Drug|erlotinib hydrochloride|Given orally
16372457|NCT00087412|Other|laboratory biomarker analysis|Correlative studies
16372458|NCT00087399|Drug|gabapentin|
16372459|NCT00087399|Drug|antidepressant|
16372460|NCT00087386|Drug|tanespimycin|Given IV
16372461|NCT00087386|Other|laboratory biomarker analysis|Correlative studies
16372462|NCT00087373|Biological|recombinant fowlpox-TRICOM vaccine|Given intratumorally
16372463|NCT00087373|Other|laboratory biomarker analysis|Correlative studies
16372464|NCT00087360|Other|counseling intervention|
16372465|NCT00087360|Other|physiologic testing|
16372466|NCT00087360|Procedure|evaluation of cancer risk factors|
16372467|NCT00087347|Drug|ferumoxytol|
16372468|NCT00087347|Procedure|magnetic resonance imaging|
16372469|NCT00087334|Drug|capecitabine|
16372470|NCT00087334|Drug|gefitinib|
16372471|NCT00087334|Drug|oxaliplatin|
16372472|NCT00087295|Drug|Depsipeptide|Depsipeptide wil be given 13 mg/m^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.
16372473|NCT00087282|Drug|alvocidib|
16372474|NCT00087282|Drug|irinotecan hydrochloride|
16372475|NCT00087269|Drug|erlotinib hydrochloride|Given orally
16372476|NCT00087269|Procedure|therapeutic endoscopic surgery|Undergo surgical resection
16372477|NCT00087269|Other|laboratory biomarker analysis|Correlative studies
16372478|NCT00087256|Drug|Celecoxib|
16372479|NCT00087256|Other|placebo|
16372480|NCT00087217|Drug|tanespimycin|Given IV
16372481|NCT00087217|Drug|paclitaxel|Given IV
16372482|NCT00087217|Other|laboratory biomarker analysis|Correlative studies
16372483|NCT00087217|Other|pharmacological study|Correlative studies
16372484|NCT00087204|Drug|becatecarin|Given IV
16372485|NCT00087204|Other|laboratory biomarker analysis|Correlative studies
16372486|NCT00087191|Drug|EF5|Given IV
16372487|NCT00087191|Drug|motexafin lutetium|Given IV
16372488|NCT00087191|Other|pharmacological study|Correlative studies
16372489|NCT00087178|Drug|cyclophosphamide|Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
16372490|NCT00087178|Drug|adriamycin|adriamycin 60 mg/m2 IV every 21 days for 4 cycles
16372493|NCT00087165|Biological|GTI-2040|
16372496|NCT00087152|Drug|Capecitabine|1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle
16372497|NCT00087152|Drug|Imatinib mesylate|400 mg by mouth daily
16372498|NCT00087139|Drug|ixabepilone|Given IV
16372499|NCT00087126|Drug|topotecan hydrochloride|
16372500|NCT00087113|Drug|pemetrexed disodium|
16372501|NCT00087100|Drug|pemetrexed disodium|
16372502|NCT00087087|Drug|pemetrexed disodium|
16372503|NCT00087074|Drug|temsirolimus|Given IV
16372504|NCT00087074|Other|laboratory biomarker analysis|Optional correlative studies
16372505|NCT00087061|Drug|gimatecan|
16372506|NCT00087048|Drug|topotecan hydrochloride|
16372507|NCT00087035|Drug|docetaxel|Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days
16372508|NCT00087035|Drug|erlotinib hydrochloride|Will be taken at a starting daily dose of 150mg
16372509|NCT00087022|Biological|girentuximab|Given IV
16372510|NCT00087022|Other|placebo|Given IV
16372511|NCT00087009|Biological|beta-glucan|Given orally
16372512|NCT00087009|Biological|rituximab|Given IV
16372513|NCT00086996|Drug|fluorouracil|Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
16372514|NCT00086996|Drug|oxaliplatin|Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
16372515|NCT00086996|Procedure|conventional surgery|The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
16372516|NCT00086996|Radiation|radiation therapy|Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.
16372517|NCT00086983|Drug|becatecarin|Given IV
16372518|NCT00086983|Drug|oxaliplatin|Given IV
16372519|NCT00086983|Other|pharmacological study|Correlative studies
16372520|NCT00086970|Drug|ifosfamide|Given IV
16372521|NCT00086970|Drug|O6-benzylguanine|Given IV
16372522|NCT00086957|Biological|trastuzumab|Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.
16372523|NCT00086957|Drug|docetaxel|75 mg/m2 every three weeks, or 60 mg/m2 every three weeks depending on study findings
16372524|NCT00086957|Drug|gefitinib|250 mg daily or 250 mg daily on days 2 through 14 depending on study findings
16372525|NCT00086944|Biological|oblimersen sodium|Given IV
16372526|NCT00086944|Biological|rituximab|Given IV
16372527|NCT00086944|Drug|ifosfamide|Given IV
16372528|NCT00086944|Drug|carboplatin|Given IV
16372529|NCT00086944|Drug|etoposide|Given IV
16372530|NCT00086944|Biological|filgrastim|Given SC
16372531|NCT00086944|Biological|pegfilgrastim|Given SC
16372532|NCT00086944|Other|laboratory biomarker analysis|Correlative studies
16372533|NCT00086931|Drug|capecitabine|oral dose escalating, twice daily.
16372534|NCT00086931|Drug|oxaliplatin|IV over 2 hours on days 1, 8, 15, 22, and 29.
16372535|NCT00086931|Procedure|conventional surgery|curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
16372536|NCT00086931|Procedure|neoadjuvant therapy|chemotherapy and radiation prior to surgery
16372537|NCT00086931|Radiation|radiation therapy|once daily 5 days a week for 5.5 weeks
16372538|NCT00086892|Biological|cetuximab|
16372539|NCT00086892|Drug|carboplatin|
16372540|NCT00086879|Drug|carmustine|
16372541|NCT00086879|Drug|erlotinib hydrochloride|
16372542|NCT00086879|Drug|temozolomide|
16372543|NCT00086866|Biological|D1/3-MAGE-3-His fusion protein|
16372544|NCT00086866|Biological|SB-AS02B adjuvant|
16372545|NCT00086866|Biological|SB-AS15 adjuvant|
16372546|NCT00086840|Drug|temsirolimus|Given IV
16372547|NCT00086840|Other|laboratory biomarker analysis|Correlative studies
16372548|NCT00086827|Drug|romidepsin|Given IV
16372549|NCT00086827|Other|laboratory biomarker analysis|Correlative studies
16372550|NCT00086801|Drug|doxorubicin hydrochloride|given IV
16372551|NCT00086801|Drug|gemcitabine hydrochloride|given IV
16372552|NCT00086801|Drug|vinblastine|given IV
16372553|NCT00086801|Procedure|fludeoxyglucose F 18 positron-emission tomography (PET) scan|
16372554|NCT00086801|Procedure|CT scan|
16372555|NCT00086775|Biological|alemtuzumab|
16372556|NCT00086775|Biological|rituximab|
16372557|NCT00086775|Drug|fludarabine phosphate|
16372558|NCT00086762|Behavioral|MR Therapy|Arm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body.
16372559|NCT00086762|Behavioral|Relaxing Music (RM) Therapy|Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment
16372560|NCT00086762|Behavioral|Standard Symptom Management|Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
16372561|NCT00086762|Behavioral|Questionnaires|Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
16372562|NCT00086736|Drug|bicalutamide|
16372563|NCT00086736|Drug|eflornithine|
16372564|NCT00086736|Drug|oral eflornithine placebo|
16372565|NCT00086736|Drug|oral bicalutamide placebo|
16372566|NCT00086723|Biological|recombinant tissue plasminogen activator|
16372567|NCT00086723|Drug|captopril|
16372568|NCT00086684|Drug|Pentosan polysulfate sodium 100 mg|One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
16372569|NCT00086684|Drug|Placebo|One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks
16372570|NCT00086684|Drug|Pentosan polysulfate sodium 100 mg|One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
16372571|NCT00086671|Drug|ABT-874/Human monoclonal antibody against IL-12|
16372572|NCT00086671|Drug|Placebo|
16372576|NCT00086619|Drug|synthetic hPTH 1-34|Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
16372577|NCT00086593|Drug|lamotrigine|
16372578|NCT00086580|Biological|FluCAM [Fludara + Campath]|"Phase A: Escalating Doses of alemtuzumab (Campath) Alone
~Day 1: alemtuzumab 3 mg intravenously (IV) over 2 hours.
~Day 2: alemtuzumab 10 mg IV over 2 hours if 3 mg was tolerated, else repeat 3 mg daily until tolerated.
~Day 3: alemtuzumab 30 mg IV over 2 hours if 10 mg was tolerated, else repeat 10 mg daily until tolerated.
~Participants were allowed 3-14 days to escalate to 30 mg. Once 30 mg was tolerated, the participant had to begin Phase B within 7 days.
~Phase B: FluCAM
~Cycle 1: Days 1,2,3 fludarabine phosphate administered at 30 mg/m^2 over 30 minutes IV, followed within 1 hour by alemtuzumab 30 mg IV over 2 hours. A similar schedule is set for Cycles 2 through 6; duration of alemtuzumab infusions vary from 2-6 hours. Each 28-day period is 1 cycle. Fludarabine phosphate dosage is based on participants' body surface area at the beginning of each cycle. FluCAM administered up to a maximum of 6 cycles, based upon participants' response to therapy and toxicity."
16372579|NCT00086580|Biological|fludarabine phosphate|Fludarabine phosphate (Fludara) is administered at a dose of 25 mg/m^2 IV over 15 to 30 minutes daily for 5 consecutive days (days 1 through 5) every 28 days (per package instructions). Each 28-day period is 1 cycle. The dose of fludarabine phosphate will be based on the participant's body surface area as calculated at the beginning of each cycle. Participants treated with fludarabine phosphate up to a maximum of 6 cycles, based upon their response to therapy and toxicity.
16372580|NCT00003297|Drug|mitoxantrone hydrochloride|
16372581|NCT00003297|Drug|thiotepa|
16372582|NCT00003297|Drug|topotecan hydrochloride|
16372583|NCT00003297|Procedure|peripheral blood stem cell transplantation|
16372584|NCT00003296|Biological|filgrastim|
16372585|NCT00003296|Drug|pegylated liposomal doxorubicin hydrochloride|
16372586|NCT00003230|Drug|paclitaxel|
16372587|NCT00003198|Drug|ifosfamide|
16372588|NCT00003198|Drug|topotecan hydrochloride|
16372589|NCT00003109|Drug|irinotecan hydrochloride|
16372590|NCT00003109|Drug|raltitrexed|
16372591|NCT00086541|Drug|Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks|
16372592|NCT00086528|Drug|XL647|Administered orally as a solution with mass-based dosing in early cohorts or as 50-mg tablets at a fixed dose at the MTD. A minimum of 3 subjects was planned for each dosing cohort with dose escalation dependent on subject tolerance of the prior dose. During the Treatment Period, subjects in each cohort were administered a single dose of XL647 on Day 1 followed by a 72-hour period of observation. If there were no XL647-related dose limiting toxicities, subjects received 5 daily doses of XL647 on Days 4-8. Twenty-one days after the initial dose, in the absence of unacceptable toxicity or disease progression, subjects could enter a Treatment Extension Period that consisted of repeated 2-week cycles of five oral doses of XL647 followed by a 9-day observation period.
16372593|NCT00086411|Drug|nicotine transdermal system|starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
16372594|NCT00086411|Drug|bupropion|150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
16372595|NCT00086411|Behavioral|Medication Management|Brief manual based therapy; four 15 minute session over 10 weeks.
16372596|NCT00086411|Behavioral|Mayo Counseling|Manual based therapy; Weekly 30 minute sessions for 10 weeks
16372597|NCT00086411|Drug|placebo patch|placebo patch containing no nicotine
16372598|NCT00086411|Drug|placebo bupropion|placebo pills
16372599|NCT00086398|Behavioral|Behavior Therapy|
16372600|NCT00086385|Drug|Nicotine polacrilex, Bupropion|Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
16372601|NCT00003091|Biological|aldesleukin|
16372602|NCT00003091|Biological|recombinant interferon alfa|
16372603|NCT00002953|Drug|cyclophosphamide|
16372604|NCT00002953|Drug|epirubicin hydrochloride|
16372605|NCT00002953|Drug|paclitaxel|
16372606|NCT00002922|Drug|paclitaxel|
16372607|NCT00002863|Drug|chemotherapy|
16372608|NCT00002863|Procedure|conventional surgery|
16372609|NCT00002863|Procedure|cryosurgery|
16372610|NCT00086515|Drug|Sitagliptin (MK0431)|Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
16372611|NCT00086515|Drug|Placebo/Glipizide 5 mg|Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
16372612|NCT00086515|Drug|Metformin|Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
16372613|NCT00086515|Drug|Pioglitazone|Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
16372614|NCT00086502|Drug|Comparator: Sitagliptin|Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
16372615|NCT00086502|Drug|Comparator: Placebo|Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24
16372616|NCT00086502|Drug|Comparator: Pioglitazone|Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
16372617|NCT00086502|Drug|Metformin|"Metformin rescue for patients meeting
~pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8"
16372618|NCT00086489|Drug|CP-675,206|pts treated at 10 mg/kg dose level on a monthly regimen
16372619|NCT00086489|Drug|CP-675,206|pts treated at 15 mg/kg dose level on a quarterly regimen
16372620|NCT00086463|Drug|Iloprost or placebo|
16372621|NCT00086450|Procedure|Coronary Artery Bypass Graft|For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.
16372713|NCT00002565|Drug|methylprednisolone|
16372714|NCT00002565|Drug|mitoxantrone hydrochloride|
16372715|NCT00002565|Drug|prednisone|
16372716|NCT00002565|Drug|vincristine sulfate|
16372799|NCT00003369|Drug|cisplatin|75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
16372622|NCT00086450|Device|Percutaneous Coronary Intervention|"For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER.
~The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery."
16372623|NCT00002999|Drug|cisplatin|
16372624|NCT00002999|Drug|fluorouracil|
16372625|NCT00002999|Radiation|radiation therapy|
16372626|NCT00086346|Drug|Sirolimus (Rapamune)|
16372627|NCT00086346|Drug|Cyclosporine or Tacrolimus|
16372628|NCT00086333|Drug|SGN-15, Docetaxel|
16372629|NCT00086359|Drug|Abacavir sulfate, lamivudine, and zidovudine|one pill twice daily
16372630|NCT00086359|Drug|Lamivudine/zidovudine|one pill twice daily
16372631|NCT00086359|Drug|Lopinavir/ritonavir|four pills twice daily
16372632|NCT00086320|Drug|Paliperidone ER|
16372633|NCT00086281|Drug|Xyrem (X)|Xyrem (Sodium Oxybate) Oral Solution
16372634|NCT00086281|Drug|Zolpidem (Z)|Zolpidem 10 mg oral tablets
16372635|NCT00086281|Drug|Modafinil (M)|Modafinil Oral Tablets
16372636|NCT00086281|Drug|Placebo (P)|Placebo Oral Solution
16372637|NCT00086268|Drug|zoledronic acid|
16372638|NCT00086268|Drug|Taxotere|
16372639|NCT00086268|Drug|Carboplatin|
16372640|NCT00002837|Biological|Filgrastim (G-CSF)|
16372641|NCT00002837|Drug|Cyclophosphamide|
16372642|NCT00002837|Drug|Doxorubicin Hydrochloride|
16372643|NCT00002837|Drug|Paclitaxel|
16372644|NCT00002837|Procedure|Peripheral Blood Stem Cell Transplantation|
16372645|NCT00002804|Biological|filgrastim|
16372646|NCT00002804|Drug|doxorubicin hydrochloride|
16372647|NCT00002804|Drug|ifosfamide|
16372648|NCT00002804|Drug|mesna|
16372649|NCT00002804|Drug|vincristine sulfate|
16372650|NCT00002804|Procedure|conventional surgery|
16372651|NCT00002804|Radiation|brachytherapy|
16372652|NCT00002804|Radiation|low-LET cobalt-60 gamma ray therapy|
16372653|NCT00002804|Radiation|low-LET electron therapy|
16372654|NCT00002804|Radiation|low-LET photon therapy|
16372655|NCT00002751|Biological|monoclonal antibody Me1-14 F(ab')2|
16372656|NCT00002733|Biological|aldesleukin|
16372657|NCT00002733|Biological|recombinant interferon alfa|
16372658|NCT00002733|Biological|therapeutic tumor infiltrating lymphocytes|
16372659|NCT00002733|Drug|cimetidine|
16372660|NCT00002705|Drug|topotecan hydrochloride|
16372661|NCT00002704|Biological|filgrastim|
16372662|NCT00002704|Drug|asparaginase|
16372663|NCT00002704|Drug|cyclophosphamide|
16372664|NCT00002704|Drug|daunorubicin hydrochloride|
16372665|NCT00002704|Drug|dexamethasone|
16372666|NCT00002704|Drug|etoposide|
16372667|NCT00002704|Drug|leucovorin calcium|
16372668|NCT00002704|Drug|liposomal cytarabine|
16372669|NCT00002704|Drug|mercaptopurine|
16372670|NCT00002704|Drug|mesna|
16372671|NCT00002704|Drug|methotrexate|
16372672|NCT00002704|Drug|therapeutic hydrocortisone|
16372673|NCT00002704|Drug|thiotepa|
16372674|NCT00002704|Drug|vincristine sulfate|
16372675|NCT00002704|Radiation|low-LET electron therapy|
16372676|NCT00002704|Radiation|low-LET photon therapy|
16372677|NCT00002691|Biological|filgrastim|
16372678|NCT00002691|Drug|asparaginase|
16372679|NCT00002691|Drug|cyclophosphamide|
16372680|NCT00002691|Drug|cytarabine|
16372681|NCT00002691|Drug|daunorubicin hydrochloride|
16372682|NCT00002691|Drug|dexamethasone|
16372683|NCT00002691|Drug|etoposide|
16372684|NCT00002691|Drug|leucovorin calcium|
16372685|NCT00002691|Drug|mesna|
16372686|NCT00002691|Drug|methotrexate|
16372687|NCT00002691|Drug|vincristine sulfate|
16372688|NCT00002654|Drug|chemotherapy|
16372689|NCT00002654|Drug|cisplatin|
16372690|NCT00002654|Radiation|low-LET cobalt-60 gamma ray therapy|
16372691|NCT00002654|Radiation|low-LET electron therapy|
16372692|NCT00002654|Radiation|low-LET photon therapy|
16372693|NCT00086307|Drug|Pramipexole|Pramipexole will be titrated so patients receive the following medication three times per day during the weeks noted: .125 milligrams (mg) in week 1, .250 mg in week 2, .5 mg in week 3, and .75 mg in weeks 4 to 6.
16372694|NCT00086307|Drug|Escitalopram|Escitalopram will be started at 10 mg/day and patients will continue on this throughout the study.
16372695|NCT00086294|Drug|Intravenous Levodopa|
16372696|NCT00086294|Drug|ACP-103|
16372697|NCT00086255|Drug|Tiagabine|
16372698|NCT00086216|Drug|Atiprimod|Oral, once a day, 14 days on 14 days off
16372699|NCT00002642|Drug|cisplatin|50 mg/m2, IV Days 1 and 8, two 28 day cycles prior to surgery and two 28 day cycles after surgery
16372700|NCT00002642|Drug|etoposide|50 mg/m2, IV Days 1-5, two 28 day cycles prior to surgery and two 28 day cycles after surgery
16372701|NCT00002642|Procedure|conventional surgery|surgery some time between weeks 9 and 12
16372702|NCT00002642|Radiation|low-LET cobalt-60 gamma ray therapy|180 cGy per day, Days 1-5, weekly for 5 weeks
16372703|NCT00002565|Biological|bleomycin sulfate|
16372704|NCT00002565|Drug|CHOP regimen|
16372705|NCT00002565|Drug|cisplatin|
16372706|NCT00002565|Drug|cyclophosphamide|
16372707|NCT00002565|Drug|cytarabine|
16372708|NCT00002565|Drug|doxorubicin hydrochloride|
16372709|NCT00002565|Drug|etoposide|
16372710|NCT00002565|Drug|idarubicin|
16372711|NCT00002565|Drug|ifosfamide|
16372712|NCT00002565|Drug|mesna|
16372717|NCT00086242|Behavioral|Psychosocial Telephone Counseling (PTC)|Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
16372718|NCT00086229|Drug|Glucosamine|
16372719|NCT00086229|Drug|Chondroitin|
16372720|NCT00086203|Drug|Talabostat mesylate (PT-100) tablets|
16372721|NCT00086203|Drug|Rituximab|
16372722|NCT00086190|Drug|paroxetine|Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
16372723|NCT00086190|Drug|venlafaxine|Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
16372724|NCT00086190|Other|placebo|an inactive substance
16372725|NCT00086177|Drug|8% progesterone vaginal gel|Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
16372726|NCT00086177|Drug|Placebo Vaginal Gel|Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
16372727|NCT00086164|Drug|edifoligide (E2F Decoy)|
16372728|NCT00086138|Drug|Sertraline (Zoloft)|Sertraline: range of 25 to 125 mg per day for 24 weeks
16372729|NCT00086138|Drug|Placebo|Placebo designed to mimic sertraline taken daily for 24 weeks
16372730|NCT00086125|Drug|ridaforolimus|AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
16372731|NCT00086112|Drug|risperidone oral tablets|
16372732|NCT00006041|Biological|MUC1-KLH conjugate vaccine|
16372733|NCT00006041|Biological|MUC1-KLH vaccine/QS21|
16372734|NCT00006041|Biological|QS21|
16372735|NCT00005975|Drug|Megestrol Acetate 20mg/day|Double blinded Megestrol Acetate 20 mg/day
16372736|NCT00005975|Drug|Megestrol Acetate 40 mg/day|Double blinded Megestrol Acetate 40 mg/day
16372737|NCT00005975|Drug|Megestrol Acetate Placebo 20 mg/day|Megestrol Acetate Placebo 20 mg/day
16372738|NCT00005975|Drug|Megestrol Acetate Placebo 40 mg/day|Megestrol Acetate Placebo 40 mg/day
16372739|NCT00005854|Drug|cyclophosphamide|
16372740|NCT00005854|Drug|cyclosporine|
16372741|NCT00005854|Drug|methotrexate|
16372742|NCT00005854|Procedure|allogeneic bone marrow transplantation|
16372743|NCT00005854|Procedure|in vitro-treated bone marrow transplantation|
16372744|NCT00005854|Radiation|radiation therapy|
16372745|NCT00002505|Biological|filgrastim|
16372746|NCT00002505|Biological|recombinant interferon gamma|
16372747|NCT00002505|Biological|tumor cell lysate vaccine therapy|
16372748|NCT00002482|Biological|antibody therapy|
16372749|NCT00002482|Biological|biological therapy|
16372750|NCT00002482|Biological|muromonab-CD3|
16372751|NCT00002482|Drug|cyclophosphamide|
16372752|NCT00086099|Drug|Idarubincin and Amufostine (Ethyol)|Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
16372753|NCT00086099|Drug|Idarubincin|Idarubincin (12mg/m2) and ara-C(N-18)
16372754|NCT00005613|Drug|cyclophosphamide|Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.
16372755|NCT00005613|Drug|etoposide|Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.
16372756|NCT00005613|Drug|BCNU|BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4
16372757|NCT00004202|Drug|carboplatin|
16372758|NCT00004202|Drug|chemotherapy|
16372759|NCT00004202|Drug|efaproxiral|
16372760|NCT00004202|Drug|paclitaxel|
16372761|NCT00004202|Radiation|radiation therapy|
16372762|NCT00004197|Biological|keyhole limpet hemocyanin|
16372763|NCT00004197|Biological|sargramostim|
16372764|NCT00004197|Biological|tumor cell-based vaccine therapy|
16372765|NCT00004197|Drug|cyclophosphamide|
16372766|NCT00004197|Drug|doxorubicin hydrochloride|
16372767|NCT00004197|Drug|mitoxantrone hydrochloride|
16372768|NCT00004197|Drug|prednisone|
16372769|NCT00004197|Drug|vincristine sulfate|
16372770|NCT00004192|Biological|filgrastim|
16372771|NCT00004192|Biological|pegfilgrastim|
16372772|NCT00004192|Drug|cisplatin|
16372773|NCT00004192|Drug|cytarabine|
16372774|NCT00004192|Drug|etoposide|
16372775|NCT00004192|Drug|methylprednisolone|
16372776|NCT00003995|Biological|trastuzumab|
16372777|NCT00003995|Drug|irinotecan hydrochloride|
16372778|NCT00003946|Drug|danazol|
16372779|NCT00086086|Drug|Darbepoetin Alfa|
16372780|NCT00003762|Drug|docetaxel|
16372781|NCT00003762|Drug|gemcitabine hydrochloride|
16372782|NCT00003723|Drug|gemcitabine hydrochloride|Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
16372783|NCT00003691|Biological|filgrastim|
16372784|NCT00003691|Drug|cisplatin|
16372785|NCT00003691|Drug|doxorubicin hydrochloride|
16372786|NCT00003691|Drug|paclitaxel|
16372787|NCT00003667|Drug|cyclophosphamide|
16372788|NCT00003667|Drug|dexrazoxane hydrochloride|
16372789|NCT00003667|Drug|disaccharide tripeptide glycerol dipalmitoyl|
16372790|NCT00003667|Drug|doxorubicin hydrochloride|
16372791|NCT00003667|Drug|vincristine sulfate|
16372792|NCT00003667|Procedure|surgical procedure|
16372793|NCT00003667|Radiation|radiation therapy|
16372794|NCT00003630|Drug|arsenic trioxide|
16372795|NCT00003549|Drug|CMF regimen|
16372796|NCT00003549|Drug|cyclophosphamide|
16372800|NCT00003369|Drug|tirapazamine|260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle
16372801|NCT00003317|Drug|carboplatin|
16372802|NCT00003317|Drug|paclitaxel|
16372803|NCT00003317|Radiation|radiation therapy|
16372804|NCT00003317|Procedure|surgery|
16372805|NCT00003127|Drug|amifostine trihydrate|740 mg/m2 IV, Day 1, q 28 days X 6 cycles
16372806|NCT00003127|Drug|carboplatin|target AUC=6, IV Day 1, q 28 days X 6 cycles
16372807|NCT00003127|Drug|paclitaxel|175 mg/m2, IV, Day 1 q 28 days X 6 cycles
16372808|NCT00086060|Behavioral|Exercise regimen|Aerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
16372809|NCT00086060|Behavioral|Relaxation training|Relaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
16372810|NCT00086060|Behavioral|Standard Care|Participants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional.
16372811|NCT00086047|Behavioral|Coping Skills Training|8 weekly sessions of behavioral treatment
16372812|NCT00086047|Behavioral|Education|8 weekly sessions of fibromyalgia education
16372813|NCT00086034|Drug|Motexafin gadolinium|
16372814|NCT00003078|Drug|cisplatin|
16372815|NCT00003078|Drug|fluorouracil|
16372816|NCT00003078|Radiation|brachytherapy|
16372817|NCT00003078|Radiation|radiation therapy|
16372818|NCT00002844|Drug|Cyclophosphamide|Daily intravenous infusions of cyclophosphamide for two days,
16372819|NCT00002844|Procedure|Allogeneic Bone Marrow Transplantation|After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
16372820|NCT00002844|Procedure|Autologous Bone Marrow Transplantation|After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
16372821|NCT00002844|Radiation|Total Body Irradiation (TBI)|Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
16372822|NCT00002816|Drug|cytarabine|Given IV
16372823|NCT00002816|Drug|dexamethasone|Given IV
16372824|NCT00002816|Drug|etoposide|Given IV
16372825|NCT00002816|Drug|idarubicin|Given IV
16372826|NCT00002816|Drug|ifosfamide|Given IV
16372827|NCT00002816|Drug|leucovorin calcium|
16372828|NCT00002816|Drug|mesna|Given IV
16372829|NCT00002816|Drug|pegaspargase|Given IV
16372830|NCT00002816|Drug|therapeutic hydrocortisone|
16372831|NCT00002816|Drug|thioguanine|
16372832|NCT00002816|Drug|vincristine sulfate|Given IV
16372833|NCT00002816|Radiation|low-LET cobalt-60 gamma ray therapy|
16372834|NCT00002816|Radiation|low-LET electron therapy|
16372835|NCT00002816|Radiation|low-LET photon therapy|
16372836|NCT00002816|Drug|Methotrexate|Given IV
16372837|NCT00002747|Drug|cisplatin|
16372838|NCT00002747|Drug|fluorouracil|
16372839|NCT00002747|Procedure|conventional surgery|
16372840|NCT00002747|Radiation|low-LET cobalt-60 gamma ray therapy|
16372841|NCT00002747|Radiation|low-LET photon therapy|
16372842|NCT00002725|Drug|bryostatin 1|
16372843|NCT00002725|Drug|chemotherapy|
16372844|NCT00086021|Procedure|Acupuncture|
16372845|NCT00085969|Drug|Placebo 0.04 mL twice daily|Subcutaneously injected, 0.04 mL, twice daily
16372846|NCT00085969|Drug|Placebo 0.04 mL once daily|Subcutaneously injected, 0.04 mL, once daily
16372847|NCT00085969|Drug|Placebo 0.08 mL once daily|Subcutaneously injected, 0.08 mL, once daily
16372848|NCT00085969|Drug|B - Exenatide 10 mcg twice daily|Subcutaneously injected, 10 mcg (0.04 mL), twice daily
16372849|NCT00085969|Drug|C - Exenatide 10 mcg once daily|Subcutaneously injected, 10 mcg (0.04 mL), once daily
16372850|NCT00085969|Drug|Exenatide 20 mcg once daily|Subcutaneously injected, 20 mcg (0.08 mL), once daily
16372851|NCT00085956|Drug|Arzoxifene|
16372852|NCT00085956|Drug|Placebo|
16372853|NCT00006241|Biological|filgrastim|
16372854|NCT00006241|Drug|chemotherapy|
16372855|NCT00006241|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372856|NCT00006241|Procedure|peripheral blood stem cell transplantation|
16372857|NCT00006241|Radiation|radiation therapy|
16372858|NCT00006235|Drug|carboplatin|
16372859|NCT00006235|Drug|pegylated liposomal doxorubicin hydrochloride|
16372860|NCT00006214|Drug|flutamide|
16372861|NCT00006214|Other|placebo|
16372862|NCT00006117|Drug|gemcitabine hydrochloride|
16372863|NCT00006117|Drug|oxaliplatin|
16372864|NCT00006116|Drug|cisplatin|
16372865|NCT00006116|Drug|gemcitabine hydrochloride|
16372866|NCT00006088|Drug|vinorelbine tartrate|
16372867|NCT00002717|Drug|cisplatin|
16372868|NCT00002717|Drug|paclitaxel|
16372869|NCT00002657|Biological|bleomycin sulfate|5 mg/m^2
16372870|NCT00002657|Biological|recombinant interferon alfa|3.0 x 10^6 IU/m^2
16372871|NCT00002657|Drug|cyclophosphamide|650 mg/m^2
16372872|NCT00002657|Drug|cytarabine|300 mg/m^2
16372873|NCT00002657|Drug|doxorubicin hydrochloride|25 mg/m^2
16372874|NCT00002657|Drug|etoposide|120 mg/m^2
16372875|NCT00002657|Drug|methotrexate|120 mg/m^2
16372876|NCT00002657|Drug|prednisone|dose varies during initial immunosuppression. During chemotherapy, 60 mg/m^2.
16372877|NCT00002657|Drug|vincristine sulfate|1.4 mg/m^2
16372878|NCT00002657|Procedure|conventional surgery|Simple excision, for those patients who have resectable disease after initial immunosuppression.
16372879|NCT00002657|Radiation|radiation therapy|For treatment of localized disease that remains after initial immunosuppression.
16372881|NCT00085943|Drug|LEXIVA (GW433908)|
16372882|NCT00085943|Drug|Ritonavir|
16372883|NCT00085943|Drug|KALETRA|
16372884|NCT00085943|Drug|EPIVIR|
16372885|NCT00085943|Drug|Ziagen|
16372886|NCT00085943|Drug|Abacavir/Lamivudine|
16372887|NCT00085943|Drug|Fosamprenavir|
16372888|NCT00085930|Biological|EBV specific CTLs|CTLs: 2x10e7 cells/m2
16372889|NCT00006035|Biological|bleomycin sulfate|
16372890|NCT00006035|Drug|electroporation therapy|
16372891|NCT00006033|Biological|gene therapy|
16372892|NCT00006033|Biological|interleukin-2 gene|
16372893|NCT00006033|Drug|methotrexate|
16372894|NCT00005993|Drug|aldesleukin|
16372895|NCT00005993|Drug|filgrastim|
16372896|NCT00005993|Drug|recombinant human stem cell factor|
16372897|NCT00005993|Procedure|peripheral blood stem cell transplantation|
16372898|NCT00005968|Drug|irofulven|
16372899|NCT00085904|Drug|SB-485232|
16372900|NCT00085891|Drug|Quetiapine Fumarate|
16372901|NCT00085878|Drug|SB-485232|
16372902|NCT00083421|Drug|ONO-2506PO|
16372903|NCT00005829|Drug|gemcitabine hydrochloride|
16372904|NCT00005826|Drug|rubitecan|
16372905|NCT00005616|Procedure|conventional surgery|
16372906|NCT00005616|Procedure|neoadjuvant therapy|
16372907|NCT00005616|Procedure|radionuclide imaging|
16372908|NCT00005616|Radiation|iodine I 131 monoclonal antibody F19|
16372909|NCT00005093|Drug|gemcitabine hydrochloride|
16372910|NCT00005093|Drug|tacedinaline|
16372911|NCT00005073|Drug|zoledronic acid|
16372912|NCT00005048|Drug|estramustine phosphate sodium|
16372913|NCT00005048|Drug|paclitaxel|
16372914|NCT00005041|Drug|tipifarnib|
16372915|NCT00004929|Biological|MUC-2-KLH vaccine|
16372916|NCT00004929|Biological|QS21|
16372917|NCT00004861|Drug|gemcitabine hydrochloride|
16372918|NCT00004861|Drug|tacedinaline|
16372919|NCT00004260|Biological|recombinant interleukin-12|
16372920|NCT00004260|Biological|rituximab|
16372921|NCT00004217|Biological|filgrastim|5 μg/kg/day IV or SC
16372922|NCT00004217|Biological|sargramostim|5 μg/kg/day IV or SC starting d 15
16372923|NCT00004217|Drug|cytarabine|Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833
16372924|NCT00004217|Drug|daunorubicin hydrochloride|continuous IV: Hours 2 - 74 before PSC-833
16372925|NCT00004217|Drug|valspodar|2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96
16372926|NCT00085917|Drug|Double dose pegylated interferon with weight based Ribavirin|pegylated interferon alfa -2a 180ug/twice weekly and weight based ribavirin for 4 weeks then pegylated interferon alfa -2a 180ug/ weekly for the remainder of the treatment
16372927|NCT00085917|Drug|standard dose pegylated interferon alfa -2a and ribavirin|pegylated interferon alfa -2a 180ug weekly and weight based ribavirin for duration of the treatment
16372928|NCT00085852|Biological|BLVR|10 mL Hydrogel
16372929|NCT00085839|Drug|Tarceva (Trademark) (erlotinib HCl, OSI-774)|Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
16372930|NCT00085839|Drug|Combination carboplatin and paclitaxel|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
16372931|NCT00085826|Drug|Exisulind|
16372932|NCT00085813|Drug|Ispinesib|
16372933|NCT00085787|Drug|ARRY-142886, MEK inhibitor; oral|Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
16372934|NCT00085774|Drug|albuterol aerosol by HFA MDI|albuterol HFA MDI 160 mcg
16372935|NCT00085774|Drug|albuterol aerosol by HFA BOI|albuterol HFA BOI 160 mcg
16372936|NCT00085774|Drug|placebo aerosol by HFA|placebo HFA
16372937|NCT00085761|Drug|Capsaicin Dermal Patch|
16372938|NCT00004251|Drug|letrozole|2.5 mg of letrozole per day
16372939|NCT00004076|Drug|mureletecan|
16372940|NCT00004043|Dietary Supplement|calcitriol|
16372941|NCT00003996|Drug|carmustine|
16372942|NCT00003996|Drug|chemotherapy|
16372943|NCT00003996|Drug|cisplatin|
16372944|NCT00003996|Drug|etoposide|
16372945|NCT00003996|Radiation|radiation therapy|
16372946|NCT00003920|Biological|filgrastim|
16372947|NCT00003920|Drug|cyclosporine|
16372948|NCT00003920|Procedure|peripheral blood stem cell transplantation|
16372949|NCT00003920|Radiation|indium In 111 monoclonal antibody m170|
16372950|NCT00003920|Radiation|yttrium Y 90 monoclonal antibody m170|
16372951|NCT00003898|Dietary Supplement|glutamine|Oral
16372952|NCT00003894|Drug|thalidomide|
16372953|NCT00003891|Drug|lurtotecan liposome|
16372954|NCT00085748|Drug|paliperidone ER|
16372955|NCT00085735|Drug|Cisplatin|Given IV
16372956|NCT00085735|Radiation|Craniospinal Irradiation|Undergo craniospinal Irradiation
16372957|NCT00085735|Drug|Cyclophosphamide|Given IV
16372958|NCT00085735|Radiation|Involved-Field Radiation Therapy|Undergo smaller volume boost (involved-field radiation therapy)
16372959|NCT00085735|Other|Laboratory Biomarker Analysis|Correlative studies
16372960|NCT00085735|Drug|Lomustine|Given orally
16372961|NCT00085735|Other|Quality-of-Life Assessment|Ancillary studies
16372962|NCT00085735|Radiation|Radiation Therapy|Undergo standard volume boost (whole posterior fossa radiation therapy)
16372963|NCT00085735|Drug|Vincristine Sulfate|Given IV
16372964|NCT00085722|Procedure|Dextrose Prolotherapy|Injection procedure: 50% dextrose is diluted with .9% 'normal' saline and 1% lidocaine to achieve 15% dextrose for ligament injections and 25% dextrose for intra-articular injection.
16372965|NCT00085722|Procedure|Saline Prolotherapy|7 mL 9% 'normal' saline and 3mL 1% lidocaine
16372966|NCT00085722|Other|At-home physical therapy exercise group|Subjects in the at-home physical therapy exercise group will receive a patient information pamphlet about knee osteoarthritis and conservative care instructions for standard at-home physical therapy exercises
16372967|NCT00085709|Drug|gemtuzumab ozogamicin|Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses >/= 28 days apart
16372968|NCT00085709|Other|observation|No treatment given
16372969|NCT00085709|Drug|Cytosine arabinoside|IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
16372970|NCT00085709|Drug|Daunomycin|IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
16372971|NCT00085644|Biological|adalimumab (D2E7)|Adalimumab 40 mg every other week, subcutaneous
16372972|NCT00085644|Biological|placebo|Placebo every other week, subcutaneous
16372973|NCT00003871|Biological|fowlpox virus vaccine vector|
16372974|NCT00003871|Biological|recombinant vaccinia prostate-specific antigen vaccine|
16372975|NCT00003860|Biological|filgrastim|
16372976|NCT00003860|Drug|carboplatin|
16372977|NCT00003860|Drug|etoposide|
16372978|NCT00003860|Drug|ifosfamide|
16372979|NCT00003860|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16372980|NCT00003847|Drug|biricodar dicitrate|
16372981|NCT00003847|Drug|doxorubicin hydrochloride|
16372982|NCT00003847|Drug|vincristine sulfate|
16372983|NCT00003829|Drug|cyclophosphamide|
16372984|NCT00003829|Drug|fludarabine phosphate|
16372985|NCT00003720|Drug|semaxanib|
16372986|NCT00003624|Drug|amifostine trihydrate|
16372987|NCT00003624|Drug|cisplatin|
16372988|NCT00003624|Drug|paclitaxel|
16372989|NCT00003592|Drug|methotrexate|
16372990|NCT00003592|Drug|paclitaxel|
16372991|NCT00003574|Procedure|surgical procedure|
16372992|NCT00003574|Radiation|brachytherapy|
16372993|NCT00003574|Radiation|intraoperative radiation therapy|
16372994|NCT00003574|Radiation|iodine I 125|
16372995|NCT00003254|Drug|ethynyluracil|10mg/m2/dose, PO, Days 1-28, q 5wk
16372996|NCT00003254|Drug|fluorouracil|1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
16372997|NCT00003242|Drug|bryostatin 1|
16372998|NCT00003242|Drug|cisplatin|
16372999|NCT00003242|Drug|paclitaxel|
16373000|NCT00003206|Drug|carboplatin|
16373001|NCT00003206|Drug|paclitaxel|
16373002|NCT00003143|Drug|Amifostine|
16373003|NCT00003143|Drug|DHAP|
16373004|NCT00003099|Drug|Fenretinide|Daily for 14-28 days.
16373005|NCT00003099|Drug|Tamoxifen Citrate|Daily for 14-28 days.
16373006|NCT00003099|Other|Placebo|Daily for 14-28 days
16373007|NCT00003085|Procedure|laparoscopy|
16373008|NCT00003085|Procedure|ultrasound imaging|
16373009|NCT00003028|Drug|sabarubicin|
16373010|NCT00003009|Biological|aldesleukin|
16373011|NCT00002973|Drug|melphalan|
16373012|NCT00002973|Procedure|hyperthermia treatment|
16373013|NCT00002949|Drug|paclitaxel|Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)
16373014|NCT00002949|Drug|vinorelbine tartrate|Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2),
16373015|NCT00002949|Radiation|radiation therapy|Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy)
16373016|NCT00002915|Drug|penclomedine|
16373017|NCT00002864|Drug|octreotide acetate|Octreotide LAR (SMS 201-995 pa LAR) 90 mg depot injection monthly for 2 years (plus Tamoxifen 20 mg PO daily for 5 years)
16373018|NCT00002864|Drug|tamoxifen citrate|20 mg PO for 5 years
16373019|NCT00002838|Biological|Filgrastim (G-CSF)|
16373020|NCT00002838|Drug|Cyclophosphamide|
16373021|NCT00002838|Drug|Fludarabine Phosphate|
16373022|NCT00002838|Procedure|Peripheral Blood Stem Cell Transplantation|
16373023|NCT00002785|Biological|filgrastim|
16373024|NCT00002785|Drug|asparaginase|
16373025|NCT00002785|Drug|cyclophosphamide|
16373026|NCT00002785|Drug|cyclosporine|
16373027|NCT00002785|Drug|cytarabine|
16373028|NCT00002785|Drug|daunorubicin hydrochloride|
16373029|NCT00002785|Drug|dexamethasone|
16373030|NCT00002785|Drug|etoposide|
16373031|NCT00002785|Drug|leucovorin calcium|
16373032|NCT00002785|Drug|mercaptopurine|
16373033|NCT00002785|Drug|mesna|
16373034|NCT00002785|Drug|methotrexate|
16373035|NCT00002785|Drug|methylprednisolone|
16373036|NCT00002785|Drug|pegaspargase|
16373037|NCT00002785|Drug|prednisone|
16373038|NCT00002785|Drug|therapeutic hydrocortisone|
16373039|NCT00002785|Drug|vincristine sulfate|
16373040|NCT00002785|Procedure|allogeneic bone marrow transplantation|
16373041|NCT00002785|Radiation|low-LET cobalt-60 gamma ray therapy|
16373042|NCT00002785|Radiation|low-LET photon therapy|
16373043|NCT00002740|Biological|filgrastim|
16373044|NCT00002740|Drug|carboplatin|
16373045|NCT00002740|Drug|cyclophosphamide|
16373046|NCT00002740|Drug|doxorubicin hydrochloride|
16373047|NCT00002740|Drug|etoposide|
16373048|NCT00002740|Drug|mesna|
16373049|NCT00002740|Drug|vincristine sulfate|
16373050|NCT00002740|Procedure|conventional surgery|
16373051|NCT00002740|Procedure|peripheral blood stem cell transplantation|
16373052|NCT00002740|Radiation|low-LET cobalt-60 gamma ray therapy|
16373053|NCT00002740|Radiation|low-LET photon therapy|
16373054|NCT00085696|Drug|VELCADE and rituximab|
16373055|NCT00085631|Drug|cisplatin|Given IV
16373056|NCT00085631|Procedure|hyperthermia treatment|Patients undergo hyperthermia treatment over 60-90 minutes
16373057|NCT00085631|Radiation|brachytherapy|Patients undergo brachytherapy for 2-3 days
16373058|NCT00085631|Radiation|external beam radiation therapy|Patients undergo external beam radiation therapy once daily on days 1-5
16373059|NCT00085579|Biological|aldesleukin|
16373060|NCT00085579|Biological|sargramostim|
16373061|NCT00085579|Procedure|adjuvant therapy|
16373062|NCT00085566|Drug|everolimus|
16373063|NCT00085566|Drug|gefitinib|
16373064|NCT00085553|Drug|Erlotinib Hydrochloride|Given PO
16373065|NCT00085553|Other|Laboratory Biomarker Analysis|Correlative studies
16373066|NCT00085553|Other|Pharmacological Study|Correlative studies
16373067|NCT00085553|Drug|Tipifarnib|Given PO
16373068|NCT00085540|Drug|depsipeptide|Given IV
16373069|NCT00085527|Drug|depsipeptide|
16373070|NCT00085501|Drug|cetuximab|"Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2.
~Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14."
16373071|NCT00085501|Drug|carboplatin|"Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2
~Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1"
16373072|NCT00085501|Drug|paclitaxel|"Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4.
~Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1."
16373073|NCT00085488|Biological|autologous tumor cell vaccine|
16373074|NCT00085488|Biological|therapeutic autologous dendritic cells|
16373075|NCT00085475|Drug|imatinib mesylate|
16373076|NCT00085475|Procedure|conventional surgery|
16373077|NCT00085462|Biological|aldesleukin|
16373078|NCT00085462|Biological|filgrastim|
16373079|NCT00085462|Biological|gp100-fowlpox vaccine|
16373080|NCT00085462|Biological|therapeutic autologous lymphocytes|
16373081|NCT00085462|Biological|therapeutic tumor infiltrating lymphocytes|
16373082|NCT00085462|Drug|cyclophosphamide|
16373083|NCT00085462|Drug|fludarabine phosphate|
16373084|NCT00085449|Biological|alemtuzumab|
16373085|NCT00085449|Drug|cyclosporine|
16373086|NCT00085449|Drug|fludarabine phosphate|
16373087|NCT00085449|Drug|melphalan|
16373088|NCT00085449|Drug|mycophenolate mofetil|
16373089|NCT00085449|Procedure|peripheral blood stem cell transplantation|
16373090|NCT00085449|Radiation|radiation therapy|
16373091|NCT00085436|Biological|Aldesleukin,|Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.
16373092|NCT00085436|Biological|autologous tumor cell vaccine|we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.
16373093|NCT00085436|Biological|recombinant interferon alfa|Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle
16373094|NCT00085423|Biological|aldesleukin|‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course
16373095|NCT00085423|Biological|sargramostim|GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.
16373096|NCT00085423|Drug|cyclophosphamide|Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.
16373097|NCT00085423|Drug|fludarabine phosphate|Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3
16373098|NCT00085410|Drug|bortezomib|Given IV
16373099|NCT00085397|Biological|autologous dendritic cell-tumor fusion vaccine|Given subcutaneously
16373100|NCT00085397|Biological|gp100 antigen|Given IV
16373101|NCT00085397|Biological|therapeutic autologous dendritic cells|Given IV
16373102|NCT00085384|Biological|PEG-interferon alfa-2b|Starting dose 1.0 mg/kg/week given subcutaneously
16373103|NCT00085384|Drug|PEG-interferon alfa-2b|"Biological/Vaccine: PEG-interferon alfa-2b
~Dose 1.25 mg/kg/week given subcutaneously"
16373104|NCT00085384|Biological|PEG-interferon alfa-2b|"Biological/Vaccine: PEG-interferon alfa-2b
~Dose 1.5 mg/kg/week given subcutaneously
~EG-Intron"
16373105|NCT00085371|Drug|triapine|Given IV
16373106|NCT00085358|Drug|carboplatin|Given intraperitoneally
16373107|NCT00085358|Drug|paclitaxel|Given IV or intraperitoneally
16373108|NCT00085358|Drug|docetaxel|Given IV
16373109|NCT00085358|Biological|bevacizumab|Given IV
16373110|NCT00085345|Drug|arsenic trioxide|
16373111|NCT00085345|Drug|ascorbic acid|
16373112|NCT00085345|Drug|melphalan|
16373113|NCT00085345|Procedure|chemosensitization/potentiation|
16373114|NCT00085345|Procedure|chemotherapy|
16373115|NCT00085332|Drug|docetaxel|
16373116|NCT00085306|Biological|recombinant interferon beta|recombinant interferon beta
16373207|NCT00084773|Biological|cetuximab|
16373208|NCT00084773|Drug|fluorouracil|
16373117|NCT00085293|Drug|Decitabine|Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
16373118|NCT00085293|Radiation|Iodine I 131|Undergo thyrotropin-alfa stimulated radioactive iodine scan
16373119|NCT00085293|Biological|Recombinant thyrotropin alfa|Undergo thyrotropin-alfa stimulated radioactive iodine scan
16373120|NCT00085293|Radiation|Fludeoxyglucose F 18|Optional correlative studies
16373121|NCT00085293|Procedure|Positron emission tomography|Optional correlative studies
16373122|NCT00085280|Drug|erlotinib hydrochloride|Given orally
16373123|NCT00085280|Other|laboratory biomarker analysis|Correlative studies
16373124|NCT00085254|Drug|cilengitide|Given IV
16373125|NCT00085254|Drug|temozolomide|Given orally
16373126|NCT00085254|Radiation|radiation therapy|Undergo radiotherapy
16373127|NCT00085254|Other|laboratory biomarker analysis|Correlative studies
16373128|NCT00085254|Other|pharmacological study|Correlative studies
16373129|NCT00085228|Biological|oblimersen sodium|
16373130|NCT00085228|Drug|docetaxel|
16373131|NCT00085202|Biological|filgrastim|Given subcutaneously
16373132|NCT00085202|Drug|cisplatin|Given IV
16373133|NCT00085202|Drug|cyclophosphamide|Given IV
16373134|NCT00085202|Drug|vincristine|Given IV
16373135|NCT00085202|Procedure|autologous hematopoietic stem cell transplantation|Patients undergo autologous stem cell transplantation
16373136|NCT00085202|Radiation|radiation therapy|Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
16373137|NCT00085189|Biological|gp100 antigen|Given SC
16373138|NCT00085189|Biological|tyrosinase peptide|Given SC
16373139|NCT00085189|Biological|recombinant MAGE-3.1 antigen|Given SC
16373140|NCT00085189|Biological|multi-epitope melanoma peptide vaccine|Given SC
16373141|NCT00085189|Biological|incomplete Freund's adjuvant|Given SC
16373142|NCT00085189|Drug|Montanide ISA 51 VG|Given SC
16373143|NCT00085189|Drug|agatolimod sodium|Given SC
16373144|NCT00085189|Other|laboratory biomarker analysis|Correlative studies
16373145|NCT00085176|Procedure|management of therapy complications|
16373146|NCT00085176|Procedure|psychosocial assessment and care|
16373147|NCT00085163|Drug|celecoxib|
16373148|NCT00085163|Drug|fluorouracil|
16373149|NCT00085163|Drug|leucovorin calcium|
16373150|NCT00085163|Procedure|adjuvant therapy|
16373151|NCT00085150|Biological|LMB-2 immunotoxin|
16373152|NCT00085124|Biological|oblimersen sodium|Given IV
16373153|NCT00085124|Drug|cytarabine|Given IV
16373154|NCT00085124|Drug|daunorubicin hydrochloride|Given IV
16373155|NCT00085124|Other|laboratory biomarker analysis|Correlative studies
16373156|NCT00085111|Biological|bevacizumab|Given IV
16373157|NCT00085098|Biological|filgrastim|Given by infusion or injection
16373158|NCT00085098|Drug|carboplatin|Given IV over 1 hour
16373159|NCT00085098|Drug|cisplatin|Given IV over 6 hours
16373160|NCT00085098|Drug|cyclophosphamide|Given IV over 1 hour
16373161|NCT00085098|Drug|etoposide|Given IV over 2 hours
16373162|NCT00085098|Radiation|radiation therapy|Patients undergo radiotherapy 5 days a week
16373163|NCT00085059|Drug|boronophenylalanine-fructose complex|
16373164|NCT00085020|Biological|trastuzumab|
16373165|NCT00085020|Drug|lapatinib ditosylate|
16373166|NCT00084981|Drug|decitabine|Given IV
16373167|NCT00084981|Drug|valproic acid|Given PO
16373168|NCT00084981|Other|pharmacological study|Correlative studies
16373169|NCT00084981|Other|laboratory biomarker analysis|Correlative studies
16373170|NCT00084942|Drug|capecitabine|
16373171|NCT00084942|Drug|gemcitabine hydrochloride|
16373172|NCT00084929|Procedure|CT Colonography|CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
16373173|NCT00084916|Drug|temsirolimus|Given IV
16373174|NCT00084916|Other|laboratory biomarker analysis|Correlative studies
16373175|NCT00084903|Procedure|Colposcopic biopsy|Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
16373176|NCT00084903|Procedure|Light-Scattering Spectroscopy|Spectroscopy readings taken in 2 regions of cervix.
16373177|NCT00084890|Drug|carboplatin|30 minute infusion dosed based on glomerular filtration rate of patient
16373178|NCT00084890|Drug|docetaxel|escalating doses ofstarting at 25 milligrams per meter squared
16373179|NCT00084877|Drug|triapine|Given IV
16373180|NCT00084877|Drug|irinotecan hydrochloride|Given IV
16373181|NCT00084877|Other|laboratory biomarker analysis|Correlative studies
16373182|NCT00084877|Other|pharmacological study|Correlative studies
16373183|NCT00084864|Dietary Supplement|calcitriol|Given orally
16373184|NCT00084864|Drug|dexamethasone|Given orally
16373185|NCT00084864|Other|clinical observation|No intervention before surgery
16373186|NCT00084838|Biological|filgrastim|
16373187|NCT00084838|Drug|cisplatin|
16373188|NCT00084838|Drug|cyclophosphamide|
16373189|NCT00084838|Drug|cytarabine|
16373190|NCT00084838|Drug|dexrazoxane hydrochloride|
16373191|NCT00084838|Drug|doxorubicin hydrochloride|
16373192|NCT00084838|Drug|etoposide|
16373193|NCT00084838|Drug|leucovorin calcium|
16373194|NCT00084838|Drug|methotrexate|
16373195|NCT00084838|Drug|temozolomide|
16373196|NCT00084838|Drug|therapeutic hydrocortisone|
16373197|NCT00084838|Drug|vincristine sulfate|
16373198|NCT00084838|Radiation|radiation therapy|
16373199|NCT00084838|Drug|Dactinomycin|
16373200|NCT00084825|Drug|Docetaxel|30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days
16373201|NCT00084825|Drug|Imatinib mesylate|600 mg orally daily
16373202|NCT00084812|Drug|cisplatin|
16373203|NCT00084812|Drug|safingol|
16373204|NCT00084799|Biological|monoclonal antibody Hu3S193|
16373205|NCT00084786|Drug|docetaxel|
16373206|NCT00084786|Drug|gefitinib|
16373209|NCT00084773|Procedure|neoadjuvant therapy|
16373210|NCT00084773|Radiation|radiation therapy|
16373211|NCT00084747|Drug|bortezomib|
16373212|NCT00084734|Drug|capecitabine|Oral
16373213|NCT00084734|Drug|cisplatin|IV
16373214|NCT00084734|Drug|docetaxel|IV
16373215|NCT00084721|Drug|celecoxib|
16373216|NCT00084721|Drug|irinotecan hydrochloride|
16373217|NCT00084708|Dietary Supplement|calcitriol|
16373218|NCT00084708|Drug|dexamethasone|
16373219|NCT00084708|Drug|gefitinib|
16373220|NCT00084695|Biological|anti-thymocyte globulin|Given IV
16373221|NCT00084695|Drug|busulfan|Given orally
16373222|NCT00084695|Drug|cyclophosphamide|Given IV
16373223|NCT00084695|Drug|fludarabine phosphate|Given IV
16373224|NCT00084695|Drug|melphalan|Given IV
16373225|NCT00084695|Drug|methylprednisolone|Given IV
16373226|NCT00084695|Radiation|radiation therapy|Patients undergo radiation therapy two times daily on days -7 to -4.
16373227|NCT00084682|Drug|romidepsin|Given IV
16373228|NCT00084669|Drug|venlafaxine|
16373229|NCT00084669|Drug|zolpidem tartrate|
16373230|NCT00084669|Procedure|management of therapy complications|
16373231|NCT00084656|Biological|ipilimumab|IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)
16373232|NCT00084656|Biological|Tyrosinase/gp100/MART-1 Peptides|(All subjects in Part I and HLA-A*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)
16373233|NCT00084643|Biological|GTI-2040|Given IV
16373234|NCT00084643|Drug|oxaliplatin|Given IV
16373235|NCT00084643|Drug|capecitabine|Given orally
16373236|NCT00084643|Other|pharmacological study|Correlative studies
16373237|NCT00084643|Other|laboratory biomarker analysis|Correlative studies
16373238|NCT00084630|Drug|imatinib mesylate|Given orally
16373239|NCT00084630|Other|laboratory biomarker analysis|Correlative studies
16373240|NCT00084617|Drug|oxaliplatin|Given IV
16373241|NCT00084617|Drug|irinotecan hydrochloride|Given IV
16373242|NCT00084617|Drug|capecitabine|Given orally
16373243|NCT00084604|Drug|irinotecan hydrochloride|Given IV
16373244|NCT00084604|Biological|bevacizumab|Given IV
16373245|NCT00084604|Drug|cisplatin|Given IV
16373246|NCT00084604|Procedure|computed tomography|Correlative studies
16373247|NCT00084604|Other|laboratory biomarker analysis|Correlative studies
16373248|NCT00084591|Drug|capecitabine|
16373249|NCT00084591|Procedure|conventional surgery|
16373250|NCT00084591|Procedure|neoadjuvant therapy|
16373251|NCT00084591|Radiation|radiation therapy|
16373252|NCT00084578|Drug|celecoxib|
16373253|NCT00084578|Drug|rosiglitazone maleate|
16373254|NCT00084578|Procedure|conventional surgery|
16373255|NCT00084578|Procedure|neoadjuvant therapy|
16373256|NCT00084565|Drug|estramustine phosphate sodium|
16373257|NCT00084565|Drug|paclitaxel|
16373258|NCT00084565|Drug|topotecan hydrochloride|
16373259|NCT00084552|Radiation|radiation therapy|Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
16373260|NCT00084539|Radiation|Radiation therapy|
16373261|NCT00084526|Procedure|computed tomography|
16373262|NCT00084526|Procedure|ultrasound imaging|
16373263|NCT00084513|Biological|trastuzumab|
16373264|NCT00084513|Drug|imatinib mesylate|
16373265|NCT00084487|Drug|becatecarin|Given IV
16373266|NCT00084461|Drug|romidepsin|Given IV
16373267|NCT00084461|Other|laboratory biomarker analysis|Correlative studies
16373268|NCT00084448|Drug|celecoxib|
16373269|NCT00084448|Drug|paclitaxel|
16373270|NCT00084435|Drug|cisplatin|75 mg/m2 IV, Day 1, q 21 days for 3 cycles
16373271|NCT00084435|Drug|docetaxel|15 mg/m2 IV, Day 1, 1 7 days for 6 doses
16373272|NCT00084435|Radiation|radiation therapy|200 cGy/day, Days 1-5, q week for 6 weeks
16373273|NCT00084422|Drug|lestaurtinib|Given orally twice daily x 5 consecutive days followed by a two day rest. 28 days = 1 treatment course. Courses repeated indefinitely without gap provided patient has recovered course from toxicities and no DLTs. Dose level assigned according to the planned dose escalation schedule.
16373274|NCT00084409|Drug|iloprost|Given orally
16373275|NCT00084409|Other|placebo|Given orally
16373276|NCT00084396|Drug|letrozole|
16373277|NCT00084396|Procedure|conventional surgery|
16373278|NCT00084383|Biological|GVAX pancreatic cancer vaccine|"Patients will receive vaccinations consisting of 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth booster vaccination, six months following the fourth vaccination."
16373279|NCT00084370|Drug|celecoxib|Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
16373280|NCT00084370|Procedure|oophorectomy|
16373281|NCT00084344|Drug|4-hydroxytamoxifen|
16373282|NCT00084344|Procedure|breast imaging study|
16373283|NCT00084344|Procedure|radiomammography|
16373284|NCT00084318|Biological|cetuximab|400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
16373285|NCT00084318|Drug|cisplatin|30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
16373286|NCT00084318|Drug|docetaxel|15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.
16373287|NCT00084318|Radiation|radiation therapy|60 Gy (2 Gy once a day, 5 times a week)
16373288|NCT00084279|Drug|Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin|interferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily
16373379|NCT00005045|Drug|carboxyamidotriazole|
16373289|NCT00084266|Drug|linezolid (Zyvox)|Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
16373290|NCT00084266|Drug|vancomycin|Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
16373291|NCT00084253|Drug|Atazanavir/ Stavidine / Lamivudine|Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
16373292|NCT00084253|Drug|Atazanavir-Ritonavir/ Stavidine / Lamivudine|Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.
16373293|NCT00084240|Drug|Azithromycin/Chloroquine|
16373294|NCT00084240|Drug|Sulfadoxine-Pyrimethamine/Chloroquine|
16373295|NCT00084227|Drug|Azithromycin/Chloroquine|
16373296|NCT00084227|Drug|Atovaquone/Proguanil|
16373297|NCT00084214|Drug|STA-4783|
16373298|NCT00084214|Drug|Paclitaxel|
16373299|NCT00002682|Drug|Amoxicillin|
16373300|NCT00002682|Drug|Bismuth Subsalicylate|
16373301|NCT00002682|Drug|Clarithromycin|
16373302|NCT00002682|Drug|Metronidazole Hydrochloride|
16373303|NCT00002682|Drug|Omeprazole|
16373304|NCT00002682|Drug|Tetracycline Hydrochloride|
16373305|NCT00002676|Drug|carmustine|
16373306|NCT00002676|Drug|cyclophosphamide|
16373307|NCT00002676|Drug|cytarabine|
16373308|NCT00002676|Drug|dexamethasone|
16373309|NCT00002676|Drug|doxorubicin hydrochloride|
16373310|NCT00002676|Drug|methotrexate|
16373311|NCT00002676|Drug|vincristine sulfate|
16373312|NCT00002676|Radiation|low-LET cobalt-60 gamma ray therapy|
16373313|NCT00002676|Radiation|low-LET photon therapy|
16373314|NCT00002670|Drug|chemotherapy|
16373315|NCT00002670|Drug|cisplatin|
16373316|NCT00002670|Radiation|low-LET cobalt-60 gamma ray therapy|
16373317|NCT00002670|Radiation|low-LET electron therapy|
16373318|NCT00002670|Radiation|low-LET photon therapy|
16373319|NCT00002656|Drug|pyrazoloacridine|"Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.
~Depending on the prior cycle toxicity the dose should be escalated, maintained or reduced, utilizing levels: -1, 0 (initial dose level), 1 - Level +1 (820mg/m2); Level 0 (750mg/m2); Level -1 (600mg/m2)"
16373320|NCT00002646|Drug|fenretinide|
16373321|NCT00002646|Drug|tamoxifen citrate|
16373322|NCT00002637|Biological|aldesleukin|
16373323|NCT00002637|Biological|gene-modified tumor cell vaccine therapy|
16373324|NCT00002637|Biological|recombinant interferon gamma|
16373325|NCT00002632|Drug|paclitaxel|
16373326|NCT00002625|Drug|topotecan hydrochloride|
16373327|NCT00002625|Radiation|low-LET electron therapy|
16373328|NCT00002625|Radiation|low-LET photon therapy|
16373329|NCT00002551|Drug|fluorouracil|See arm assignments.
16373330|NCT00002551|Drug|leucovorin calcium|See arm assignments.
16373331|NCT00002551|Drug|levamisole hydrochloride|See arm assignments.
16373332|NCT00002551|Radiation|radiation therapy|See arm assignments.
16373333|NCT00002538|Procedure|laparoscopic surgery|
16373334|NCT00084201|Drug|Cranberry juice|
16373335|NCT00084201|Drug|Amoxicillin|
16373336|NCT00084188|Behavioral|Behavior Therapy|
16373337|NCT00084175|Behavioral|Behavior Therapy|
16373338|NCT00006451|Drug|anti-thymocyte globulin|
16373339|NCT00006451|Drug|cyclophosphamide|
16373340|NCT00006451|Drug|cyclosporine|
16373341|NCT00006451|Drug|methotrexate|
16373342|NCT00006451|Drug|methylprednisolone|
16373343|NCT00006451|Procedure|allogeneic bone marrow transplantation|
16373344|NCT00006451|Procedure|in vitro-treated bone marrow transplantation|
16373345|NCT00006451|Procedure|radiation therapy|
16373346|NCT00006387|Biological|QS21|
16373347|NCT00006387|Biological|ras peptide cancer vaccine|
16373348|NCT00006382|Procedure|bronchoscopic and lung imaging studies|
16373349|NCT00006382|Procedure|comparison of screening methods|
16373350|NCT00006382|Procedure|computed tomography|
16373351|NCT00006382|Procedure|radiography|
16373352|NCT00006382|Procedure|study of high risk factors|
16373353|NCT00006380|Biological|monoclonal antibody muJ591|
16373354|NCT00006380|Radiation|iodine I 131 monoclonal antibody muJ591|
16373355|NCT00006378|Drug|carboplatin|
16373356|NCT00006378|Drug|paclitaxel|
16373357|NCT00006378|Radiation|radiation therapy|
16373358|NCT00006374|Biological|filgrastim|
16373359|NCT00006374|Drug|cisplatin|
16373360|NCT00006374|Drug|etoposide|
16373361|NCT00006374|Drug|paclitaxel|
16373362|NCT00006374|Drug|topotecan hydrochloride|
16373363|NCT00006251|Radiation|total-body irradiation|Undergo TBI
16373364|NCT00006251|Drug|fludarabine phosphate|Given IV
16373365|NCT00006251|Drug|cyclosporine|Given PO
16373366|NCT00006251|Drug|mycophenolate mofetil|Given PO
16373367|NCT00006251|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC transplant
16373368|NCT00006251|Biological|donor lymphocytes|Undergo DLI
16373369|NCT00006251|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
16373370|NCT00006251|Other|laboratory biomarker analysis|Correlative studies
16373371|NCT00005994|Drug|ondansetron|
16373372|NCT00005790|Other|laboratory biomarker analysis|
16373373|NCT00005790|Procedure|biopsy|
16373374|NCT00005790|Procedure|magnetic resonance imaging|
16373375|NCT00005790|Radiation|gadopentetate dimeglumine|
16373376|NCT00005084|Procedure|conventional surgery|
16373377|NCT00005084|Procedure|magnetic resonance spectroscopic imaging|
16373378|NCT00005084|Radiation|radiation therapy|
16373380|NCT00004236|Drug|pegylated liposomal doxorubicin hydrochloride|
16373381|NCT00003992|Biological|trastuzumab|
16373382|NCT00003992|Drug|cyclophosphamide|
16373383|NCT00003992|Drug|doxorubicin hydrochloride|
16373384|NCT00003992|Drug|paclitaxel|
16373385|NCT00003992|Drug|tamoxifen citrate|
16373386|NCT00003859|Drug|carboplatin|
16373387|NCT00003859|Drug|cyclophosphamide|
16373388|NCT00003859|Drug|etoposide|
16373389|NCT00003859|Drug|vincristine sulfate|
16373390|NCT00003859|Procedure|surgical procedure|
16373391|NCT00003859|Radiation|radiation therapy|
16373392|NCT00003733|Drug|carboplatin|
16373393|NCT00003733|Drug|paclitaxel|
16373394|NCT00003733|Drug|topotecan hydrochloride|
16373395|NCT00003584|Drug|estramustine phosphate sodium|
16373396|NCT00003584|Drug|prednisone|
16373397|NCT00003584|Drug|vinorelbine tartrate|
16373398|NCT00003435|Biological|anti-thymocyte globulin|
16373399|NCT00003435|Drug|melphalan|
16373400|NCT00003435|Procedure|antiviral therapy|
16373401|NCT00003435|Procedure|bone marrow ablation with stem cell support|
16373402|NCT00003435|Procedure|peripheral blood stem cell transplantation|
16373403|NCT00003435|Procedure|umbilical cord blood transplantation|
16373404|NCT00003435|Radiation|radiation therapy|
16373405|NCT00003410|Drug|motexafin gadolinium|
16373406|NCT00003410|Procedure|magnetic resonance imaging|
16373407|NCT00003410|Procedure|surgical procedure|
16373408|NCT00003372|Drug|topotecan hydrochloride|
16373409|NCT00003236|Biological|ISIS 3521|
16373410|NCT00003236|Drug|ISIS 5132|
16373411|NCT00002905|Drug|cyclophosphamide|
16373412|NCT00002905|Drug|didanosine|
16373413|NCT00002905|Drug|doxorubicin hydrochloride|
16373414|NCT00002905|Drug|etoposide|
16373415|NCT00002905|Drug|mitoxantrone hydrochloride|
16373416|NCT00002905|Drug|prednimustine|
16373417|NCT00002905|Drug|zidovudine|
16373418|NCT00002496|Drug|chemotherapy|
16373419|NCT00002496|Drug|cisplatin|
16373420|NCT00002496|Drug|fluorouracil|
16373421|NCT00002496|Procedure|conventional surgery|
16373422|NCT00002496|Radiation|low-LET cobalt-60 gamma ray therapy|
16373423|NCT00002496|Radiation|low-LET electron therapy|
16373424|NCT00002496|Radiation|low-LET photon therapy|
16373425|NCT00002478|Drug|etoposide|
16373426|NCT00002476|Biological|bleomycin sulfate|
16373427|NCT00002476|Drug|fluorouracil|
16373428|NCT00002476|Drug|leucovorin calcium|
16373429|NCT00002476|Drug|methotrexate|
16373430|NCT00002476|Drug|vincristine sulfate|
16373431|NCT00002476|Radiation|low-LET cobalt-60 gamma ray therapy|
16373432|NCT00002476|Radiation|low-LET photon therapy|
16373433|NCT00002476|Radiation|radiation therapy|
16373434|NCT00002460|Drug|goserelin acetate|
16373435|NCT00002460|Drug|tamoxifen citrate|
16373436|NCT00002460|Procedure|ablative endocrine surgery|
16373437|NCT00002460|Procedure|oophorectomy|
16373438|NCT00084149|Drug|Abacavir sulfate, Lamivudine, and Zidovudine|antiretroviral therapy
16373439|NCT00084149|Drug|Lopinavir/Ritonavir|antiretroviral therapy
16373440|NCT00084136|Drug|Atazanavir|400 mg taken orally daily
16373441|NCT00084136|Drug|Didanosine (enteric-coated)|400 mg taken orally daily
16373442|NCT00084136|Drug|Efavirenz|600 mg taken orally daily
16373443|NCT00084136|Drug|Emtricitabine|200 mg taken orally daily
16373444|NCT00084136|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg/300 mg taken orally once daily
16373445|NCT00084136|Drug|Lamivudine/Zidovudine|150 mg/300 mg taken orally twice daily
16373446|NCT00084123|Behavioral|Healing Touch Therapy|
16373447|NCT00084123|Behavioral|Relaxation Therapy|
16373448|NCT00084123|Behavioral|Standard Care|Standard Care
16373449|NCT00084071|Drug|Tifacogin|
16373450|NCT00083993|Drug|Temsirolimus (CCI-779) for 34 months|
16373451|NCT00083993|Drug|Letrozole for 34 months|
16373452|NCT00005960|Biological|filgrastim|
16373453|NCT00005960|Drug|cyclophosphamide|
16373454|NCT00005960|Drug|docetaxel|
16373455|NCT00005960|Drug|doxorubicin hydrochloride|
16373456|NCT00005960|Procedure|pain therapy|
16373457|NCT00005641|Biological|anti-thymocyte globulin|
16373458|NCT00005641|Drug|busulfan|
16373459|NCT00005641|Drug|cyclophosphamide|
16373460|NCT00005641|Drug|cyclosporine|
16373461|NCT00005641|Drug|leucovorin calcium|
16373462|NCT00005641|Drug|methotrexate|
16373463|NCT00005641|Drug|methylprednisolone|
16373464|NCT00005641|Procedure|allogeneic bone marrow transplantation|
16373465|NCT00005641|Procedure|in vitro-treated bone marrow transplantation|
16373466|NCT00005641|Radiation|radiation therapy|
16373467|NCT00005091|Drug|exatecan mesylate|
16373468|NCT00005054|Drug|temozolomide|
16373469|NCT00005050|Drug|ethynyluracil|
16373470|NCT00005050|Drug|fluorouracil|
16373471|NCT00005050|Drug|oxaliplatin|
16373472|NCT00084097|Drug|Omalizumab|
16373473|NCT00084084|Drug|Agalsidase alfa|0.2 mg/kg agalsidase alfa administered by IV infusion over 40 (+/- 10) minutes every other week for 52 weeks, with periodic reassessments for study continuation beyond 52 weeks
16373474|NCT00084058|Drug|Lopinavir/ritonavir|
16373475|NCT00084058|Drug|Saquinavir|
16373476|NCT00084045|Procedure|Intrapartum HIV counseling/testing|
16373477|NCT00084045|Procedure|Postpartum HIV counseling/testing|
16373478|NCT00084032|Behavioral|Structured treatment interruption|Treatment interruption schedule is dependent on the Arm in which participants are enrolled in Step 2
16373479|NCT00084032|Drug|Antiretroviral regimen|Participants will take any combination of FDA-approved ARV medications prescribed by their physician
16373480|NCT00084019|Drug|Atazanavir|
16373481|NCT00084019|Drug|Ritonavir|
16373482|NCT00083980|Drug|Venlafaxine ER|75 to 225 mg daily
16373483|NCT00083980|Drug|Sugar pill|Upto 3 per day for venlafainxe and 4 per day for kava placebos.
16373484|NCT00083980|Drug|Kava|140 to 280 mg per day
16373485|NCT00083967|Drug|denufosol tetrasodium (INS37217) Intravitreal Injection|
16373486|NCT00083954|Drug|Quetiapine Fumarate|
16373487|NCT00083941|Biological|TroVax|1ml intramuscular injection
16373488|NCT00083941|Biological|Interleukin-2|Intravenous IL-2
16373489|NCT00083928|Drug|Å6 subcutaneous injection|
16373490|NCT00083915|Drug|Cisplatin|20mg/m2 continuous infusion days -3 and -2.
16373491|NCT00083915|Drug|Cyclophosphamide|800 mg/m2 continuous infusion days -3 and -2.
16373492|NCT00083915|Drug|Adriamycin|20mg/m2 continuous infusion -3 and -2.
16373493|NCT00083915|Drug|Etoposide|80mg/m2 continuous infusion -3 and -2.
16373494|NCT00083915|Drug|Melphalan|200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
16373495|NCT00083915|Drug|Thalidomide|200mg PO Continuing to Day +5, then hold until platelets >50 thousand (K).
16373496|NCT00083915|Drug|Dexamethasone|40 mg po days 1 - 4 (4 days)
16373497|NCT00083902|Drug|Thalidomide|
16373498|NCT00083902|Drug|Dexamethasone|
16373499|NCT00083889|Drug|Interferon-alfa|3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
16373500|NCT00083889|Drug|SU011248|50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
16373501|NCT00083876|Drug|Thalidomide|
16373502|NCT00083824|Drug|Estrogens, Conjugated (USP)|0.625 mg/day QID for 3 years
16373503|NCT00083824|Drug|Medroxyprogesterone 17-Acetate|2.5 mg/day QID for 3 years
16373504|NCT00083824|Drug|Placebo|2 pills/day QID for 3 years
16373505|NCT00005032|Biological|oblimersen sodium|
16373506|NCT00005032|Drug|paclitaxel|
16373507|NCT00005030|Drug|SCH 66336|
16373508|NCT00005030|Procedure|conventional surgery|Exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.
16373509|NCT00004979|Drug|paclitaxel|
16373510|NCT00004979|Drug|topotecan hydrochloride|
16373511|NCT00004927|Drug|ixabepilone|
16373512|NCT00004877|Drug|BMS-214662|
16373513|NCT00004161|Drug|fenretinide|
16373514|NCT00004161|Drug|Placebo|
16373515|NCT00004146|Radiation|radiation therapy|Undergo radiotherapy
16373516|NCT00004146|Drug|carboxyamidotriazole|Given orally
16373517|NCT00004146|Other|pharmacological study|Correlative studies
16373518|NCT00004071|Drug|leflunomide|
16373519|NCT00004071|Drug|mitoxantrone hydrochloride|
16373520|NCT00004071|Drug|prednisone|
16373521|NCT00004070|Biological|IL-12|
16373522|NCT00004062|Drug|azacitidine|
16373523|NCT00004062|Drug|liothyronine sodium|
16373524|NCT00004062|Radiation|iodine I 131|
16373525|NCT00083785|Drug|Talaporfin sodium (LS11)|
16373526|NCT00083785|Device|LED-based light infusion device|
16373527|NCT00083785|Device|Light emitting diodes (LED)|
16373528|NCT00083785|Procedure|Photodynamic therapy|
16373529|NCT00083785|Procedure|Phototherapy|
16373530|NCT00083785|Procedure|Chemotherapy|
16373531|NCT00083772|Drug|Nesiritide|Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
16373532|NCT00083759|Drug|natalizumab|
16373533|NCT00083759|Drug|placebo|
16373534|NCT00004055|Biological|filgrastim|
16373535|NCT00004055|Drug|paclitaxel|
16373536|NCT00004055|Drug|topotecan hydrochloride|
16373537|NCT00003998|Drug|carboplatin|
16373538|NCT00003998|Drug|docetaxel|
16373539|NCT00003998|Drug|paclitaxel|
16373540|NCT00003998|Procedure|surgical procedure|
16373541|NCT00003997|Drug|irofulven|
16373542|NCT00003991|Biological|aldesleukin|
16373543|NCT00003991|Drug|histamine dihydrochloride|
16373544|NCT00003939|Drug|trabectedin|
16373545|NCT00003856|Drug|temoporfin|
16373546|NCT00003850|Drug|thalidomide|
16373547|NCT00003787|Behavioral|educational/counseling intervention|
16373548|NCT00003787|Behavioral|therapeutic dietary intervention|
16373549|NCT00003773|Drug|oglufanide disodium|
16373550|NCT00003758|Drug|cytarabine|
16373551|NCT00003758|Drug|idarubicin|
16373552|NCT00003758|Procedure|allogeneic bone marrow transplantation|
16373553|NCT00003758|Procedure|autologous bone marrow transplantation|
16373554|NCT00003758|Procedure|peripheral blood stem cell transplantation|
16373555|NCT00003755|Drug|MKC-1|
16373556|NCT00003740|Biological|trastuzumab|
16373557|NCT00003443|Drug|bryostatin 1|
16373558|NCT00003401|Drug|carmustine|
16373559|NCT00003401|Drug|cisplatin|
16373560|NCT00003401|Drug|cyclophosphamide|
16373561|NCT00003401|Drug|dexamethasone|
16373562|NCT00003401|Drug|etoposide|
16373563|NCT00003401|Drug|gemcitabine hydrochloride|
16373564|NCT00003401|Drug|melphalan|
16373565|NCT00003401|Drug|paclitaxel|
16373566|NCT00003401|Procedure|bone marrow ablation with stem cell support|
16373567|NCT00003401|Procedure|peripheral blood stem cell transplantation|
16373568|NCT00003399|Drug|carmustine|
16373569|NCT00003399|Drug|cisplatin|
16373570|NCT00003399|Drug|cyclophosphamide|
16373571|NCT00003399|Drug|dexamethasone|
16373572|NCT00003399|Drug|etoposide|
16373573|NCT00003399|Drug|melphalan|
16373574|NCT00003399|Drug|paclitaxel|
16373575|NCT00003399|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16373576|NCT00003396|Biological|anti-thymocyte globulin|
16373577|NCT00003396|Biological|graft-versus-tumor induction therapy|
16373578|NCT00003396|Drug|cyclophosphamide|
16373579|NCT00003396|Drug|melphalan|
16373580|NCT00003396|Procedure|peripheral blood stem cell transplantation|
16373581|NCT00003396|Radiation|radiation therapy|
16373582|NCT00003293|Drug|leflunomide|
16373583|NCT00003293|Drug|procarbazine hydrochloride|
16373584|NCT00003249|Drug|carboxyamidotriazole|
16373585|NCT00003249|Drug|chemotherapy|
16373586|NCT00003249|Drug|ketoconazole|
16373587|NCT00003231|Drug|cisplatin|
16373588|NCT00003231|Drug|docetaxel|
16373589|NCT00003231|Procedure|surgical procedure|
16373590|NCT00003231|Radiation|radiation therapy|
16373591|NCT00083720|Biological|cetuximab|Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
16373592|NCT00083707|Drug|Thalidomide|
16373593|NCT00083694|Drug|Thalidomide|
16373594|NCT00083681|Drug|Thalidomide|
16373595|NCT00083681|Drug|Dexamethasone|
16373596|NCT00083681|Drug|Cytoxan|
16373597|NCT00083681|Drug|Etoposide|
16373598|NCT00083681|Drug|Cisplatin|
16373599|NCT00083681|Drug|G-CSF|
16373600|NCT00083668|Drug|Paliperidone ER|
16373601|NCT00083616|Biological|Panitumumab|Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.
16373602|NCT00083564|Drug|STR(TM) (Skeletal Targeted Radiotherapy, Holmium-166-DOTMP)|
16373603|NCT00083629|Procedure|PET|
16373604|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^7 pfu /2mL administered in each deltoid
16373605|NCT00083603|Biological|rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)|Vaccines administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid
16373606|NCT00083603|Biological|Empty TBC-FPV|Empty FPV 10^9 pfu/2mL administered as two separate 1 mL intramuscular injections, one into each deltoid.
16373607|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^8 pfu /2mL administered in each deltoid
16373608|NCT00083603|Biological|rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)|rMVA 10^9 pfu /2mL administered in each deltoid
16373609|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^7 pfu/2mL administered into each deltoid
16373610|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^8 pfu/2mL administered into each deltoid
16373611|NCT00083603|Biological|TBC-MVA and TBC-FPV|Empty MVA 10^9 pfu/2mL administered into each deltoid
16373612|NCT00083590|Drug|Huperzine A|
16373613|NCT00083577|Drug|Thalidomide|
16373614|NCT00083551|Drug|Thalidomide|All patients will be randomly assigned to receive thalidomide 400 mg as an oral, once daily dose throughout induction and 100mg between transplants after platelets are greater than 50,000μl and 200 mg post transplant consolidation, and a reduced dose of 100 mg on alternating days during the first year of maintenance and 50 mg qod thereafter versus no thalidomide. Thalidomide will be held during conditioning, transplant procedure, and recovery following transplant. It may be resumed once plateletrecovery is complete after each transplant
16373615|NCT00083551|Drug|Ara-C|"Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2).
~Start infusion 30 minutes after completion of BCNU on day -5."
16373616|NCT00083551|Drug|BCNU|Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion
16373617|NCT00083551|Drug|Cisplatin|"Cisplatin* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle)
~*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) < 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) > 3.0 mg/dl"
16373618|NCT00083551|Drug|Cytoxan|Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4
16373619|NCT00083551|Drug|Dexamethasone|Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as < 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20
16373620|NCT00083551|Drug|Doxorubicin|Doxorubicin may be further diluted in 5% dextrose or sodium chloride injection and should be administered slowly into tubing of a freely flowing intravenous infusion with great care taken to avoid extravasation.
16373621|NCT00083551|Drug|Etoposide|Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
16373622|NCT00083551|Drug|Filgrastim|G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
16373623|NCT00083551|Drug|Recombinant GM-CSF|GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.
16373624|NCT00083551|Drug|Interferon-alpha-2b|AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod
16373625|NCT00083551|Drug|Melphalan|Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days
16373626|NCT00083551|Drug|Vincristine|Formulation: 1 mg/1 ml, 2 mg/2 ml, and 5 mg/ 5 ml vials. Vincristine should be administered intravenously through a freely-running IV. If it extravasates, it produces a severe local reaction with skin slough. FATAL IF GIVEN INTRATHECALLY, FOR INTRAVENOUS USE ONLY.
16373627|NCT00083538|Drug|Dexamethasone|
16373636|NCT00003079|Drug|cytarabine|
16373637|NCT00003075|Drug|Fenretinide|Oral Fenretinide daily for 6 months with 3 days of rest every month.
16373638|NCT00003075|Other|Placebo|Oral placebo daily for 6 months with 3 days of rest every month.
16373639|NCT00003031|Drug|amphotericin B deoxycholate|
16373640|NCT00003031|Drug|voriconazole|
16373641|NCT00003015|Drug|carboplatin|
16373642|NCT00003015|Drug|vincristine sulfate|
16373643|NCT00003015|Procedure|conventional surgery|
16373644|NCT00003015|Radiation|radiation therapy|
16373645|NCT00083525|Drug|WX-UK1 in combination with Capecitabine|
16373646|NCT00083473|Drug|Pivanex|
16373647|NCT00083460|Drug|PS-341|Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
16373648|NCT00083460|Drug|Thalidomide|In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
16373649|NCT00083460|Drug|Dexamethasone|A dose of 20mg for cylces 3-8.
16373650|NCT00083447|Drug|TransMID™|
16373651|NCT00083434|Drug|Epoetin alfa|
16373652|NCT00006877|Drug|temozolomide|
16373653|NCT00006358|Drug|temozolomide|
16373654|NCT00006358|Drug|thalidomide|
16373655|NCT00006343|Biological|recombinant interferon alfa|
16373656|NCT00006343|Drug|cytarabine|
16373657|NCT00006343|Drug|imatinib mesylate|
16373658|NCT00006222|Drug|cilengitide|
16373659|NCT00006212|Drug|cisplatin|
16373660|NCT00006212|Drug|vinblastine sulfate|
16373661|NCT00006212|Radiation|phosphorus P32|
16373662|NCT00006212|Radiation|radiation therapy|
16373663|NCT00006083|Drug|Fragmin|Fragmin at 5000 IU injected subcutaneously daily
16373664|NCT00006083|Other|placebo|placebo injected subcutaneously daily
16373665|NCT00006079|Drug|Eflornithine|Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days.
16373666|NCT00006079|Other|Placebo|Patients receive oral placebo daily for 28 days.
16373667|NCT00006001|Drug|semaxanib|
16373668|NCT00005942|Drug|liposomal daunorubicin citrate|Given IV
16373669|NCT00005942|Drug|semaxanib|Given IV
16373670|NCT00005942|Other|laboratory biomarker analysis|Correlative studies
16373671|NCT00005939|Radiation|brachytherapy|
16373672|NCT00005939|Radiation|phosphorus P32|
16373673|NCT00005841|Biological|MART-1 antigen|
16373674|NCT00005841|Biological|gp100 antigen|
16373675|NCT00005841|Biological|incomplete Freund's adjuvant|
16373676|NCT00005841|Biological|progenipoietin|
16373677|NCT00005841|Biological|tyrosinase peptide|
16373678|NCT00005645|Drug|ILX-295501|
16373679|NCT00005640|Procedure|Preoperative Endoscopy|
16373680|NCT00005640|Radiation|Technetium Tc 99m Sulfur Colloid|
16373681|NCT00005640|Procedure|Gamma Probe|
16373682|NCT00005640|Procedure|Biopsy of Sentinel Lymph Nodes|
16373683|NCT00005636|Drug|cisplatin|
16373684|NCT00005636|Drug|pemetrexed disodium|
16373685|NCT00005578|Biological|bleomycin sulfate|
16373686|NCT00005578|Biological|filgrastim|
16373687|NCT00005578|Drug|cyclophosphamide|
16373688|NCT00005578|Drug|dexrazoxane hydrochloride|
16373689|NCT00005578|Drug|doxorubicin hydrochloride|
16373690|NCT00005578|Drug|etoposide|
16373691|NCT00005578|Drug|prednisone|
16373692|NCT00005578|Drug|vincristine sulfate|
16373693|NCT00005578|Radiation|radiation therapy|
16373694|NCT00005088|Drug|cisplatin|
16373695|NCT00005088|Radiation|radiation therapy|
16373696|NCT00005069|Drug|arsenic trioxide|
16373697|NCT00005059|Drug|carboplatin|
16373698|NCT00005059|Drug|paclitaxel|
16373699|NCT00002923|Drug|KRN5500|
16373700|NCT00002917|Drug|paclitaxel|
16373701|NCT00002911|Drug|marimastat|
16373702|NCT00002829|Biological|Recombinant Interferon Alfa|Daily
16373703|NCT00002829|Drug|Cyclophosphamide|Infused intravenously over 2 hours daily on Day -7 and -6.
16373704|NCT00002829|Drug|Etoposide|Administered intravenously on Day -8
16373705|NCT00002829|Drug|Mesna|Beginning 1 hour after initiation of the cyclophosphamide treatment.
16373706|NCT00002829|Procedure|Bone Marrow Transplantation|Infusion on Day 0.
16373707|NCT00002829|Radiation|Radiation Therapy|Total body irradiation is received on days -4, -3, -2 , and -1.
16373708|NCT00002827|Biological|bleomycin sulfate|Given IV
16373709|NCT00002827|Biological|filgrastim|Given IV
16373710|NCT00002827|Drug|dexrazoxane hydrochloride|Given IV
16373711|NCT00002827|Drug|doxorubicin hydrochloride|Given IV
16373712|NCT00002827|Drug|etoposide|Given IV
16373713|NCT00002827|Drug|vincristine sulfate|Given IV
16373714|NCT00002827|Radiation|low-LET cobalt-60 gamma ray therapy|
16373715|NCT00002827|Radiation|low-LET electron therapy|
16373716|NCT00002827|Radiation|low-LET photon therapy|
16373717|NCT00002819|Drug|carboplatin|
16373718|NCT00002819|Drug|cyclophosphamide|
16373719|NCT00002819|Drug|mitoxantrone hydrochloride|
16373720|NCT00002819|Drug|paclitaxel|
16373721|NCT00002819|Procedure|autologous bone marrow transplantation|
16373722|NCT00002819|Procedure|peripheral blood stem cell transplantation|
16373723|NCT00002806|Drug|lomustine|
16373724|NCT00002806|Drug|procarbazine hydrochloride|
16373725|NCT00002806|Drug|vincristine sulfate|
16373726|NCT00002806|Radiation|low-LET photon therapy|
16373727|NCT00002721|Drug|doxorubicin hydrochloride|
16373728|NCT00002721|Drug|estramustine phosphate sodium|
16373729|NCT00002721|Procedure|drug resistance inhibition treatment|
16373730|NCT00002639|Drug|chemotherapy|
16373731|NCT00002639|Drug|suramin|
16373732|NCT00002602|Radiation|3D-CRT|3 dimensional conformal radiation therapy
16373733|NCT00002555|Drug|cisplatin|
16373734|NCT00002555|Radiation|low-LET cobalt-60 gamma ray therapy|
16374096|NCT00003423|Drug|prednisolone|
16373735|NCT00002555|Radiation|low-LET electron therapy|
16373736|NCT00002555|Radiation|low-LET photon therapy|
16373737|NCT00002477|Drug|carboplatin|
16373738|NCT00002477|Drug|cisplatin|
16373739|NCT00002477|Drug|cyclophosphamide|
16373740|NCT00002477|Drug|doxorubicin hydrochloride|
16373741|NCT00083408|Drug|Pamidronate|
16373742|NCT00083408|Drug|Thalidomide|
16373743|NCT00004881|Biological|MVA-MUC1-IL2 vaccine|
16373744|NCT00004200|Drug|prinomastat|
16373745|NCT00004200|Drug|temozolomide|
16373746|NCT00004190|Drug|gemcitabine hydrochloride|
16373747|NCT00004190|Drug|oxaliplatin|
16373748|NCT00004176|Drug|amifostine trihydrate|
16373749|NCT00004176|Drug|cisplatin|
16373750|NCT00004176|Drug|etoposide|
16373751|NCT00004176|Radiation|radiation therapy|
16373752|NCT00004139|Drug|docetaxel|
16373753|NCT00004139|Drug|gemcitabine hydrochloride|
16373754|NCT00004139|Drug|irinotecan hydrochloride|
16373755|NCT00004112|Biological|rituximab|
16373756|NCT00004112|Drug|CHOP regimen|
16373757|NCT00004112|Drug|cyclophosphamide|
16373758|NCT00004112|Drug|doxorubicin hydrochloride|
16373759|NCT00004112|Drug|prednisone|
16373760|NCT00004112|Drug|vincristine sulfate|
16373761|NCT00004105|Drug|estramustine phosphate sodium|
16373762|NCT00004105|Drug|paclitaxel|
16373763|NCT00004105|Drug|vinorelbine ditartrate|
16373764|NCT00004061|Biological|filgrastim|
16373765|NCT00004061|Biological|palifermin|
16373766|NCT00004061|Drug|cyclophosphamide|
16373767|NCT00004061|Drug|etoposide|
16373768|NCT00004061|Drug|ifosfamide|
16373769|NCT00004061|Procedure|peripheral blood stem cell transplantation|
16373770|NCT00004061|Procedure|quality-of-life assessment|
16373771|NCT00004061|Radiation|radiation therapy|
16373772|NCT00004030|Drug|VX-853|
16373773|NCT00004030|Drug|pegylated liposomal doxorubicin hydrochloride|
16373774|NCT00004012|Drug|capecitabine|
16373775|NCT00003985|Drug|KRN7000|
16373776|NCT00003984|Biological|lintuzumab|
16373777|NCT00003982|Drug|sabarubicin|
16373778|NCT00003980|Drug|BIBX 1382|
16373779|NCT00003944|Biological|filgrastim|
16373780|NCT00003944|Drug|carboplatin|
16373781|NCT00003944|Drug|cyclophosphamide|
16373782|NCT00003944|Drug|paclitaxel|
16373783|NCT00003944|Drug|topotecan hydrochloride|
16373784|NCT00003944|Procedure|peripheral blood stem cell transplantation|
16373785|NCT00003846|Biological|filgrastim|
16373786|NCT00003846|Drug|carboplatin|
16373787|NCT00003846|Drug|cyclophosphamide|
16373788|NCT00003846|Drug|thiotepa|
16373789|NCT00003846|Drug|vincristine sulfate|
16373790|NCT00003846|Procedure|bone marrow ablation with stem cell support|
16373791|NCT00003846|Procedure|peripheral blood stem cell transplantation|
16373792|NCT00003846|Radiation|radiation therapy|
16373793|NCT00003752|Drug|bexarotene|
16373794|NCT00003669|Drug|arzoxifene hydrochloride|
16373795|NCT00003580|Drug|amifostine trihydrate|
16373796|NCT00003580|Drug|cisplatin|
16373797|NCT00003580|Radiation|radiation therapy|
16373798|NCT00083382|Drug|Pamidronate|Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
16373799|NCT00083382|Drug|Thalidomide|"All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met.
~Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)"
16373800|NCT00083382|Drug|Zometa|Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
16373801|NCT00083343|Drug|MK0991, caspofungin acetate/Duration of Treatment: variable|
16373802|NCT00008229|Biological|filgrastim|
16373803|NCT00008229|Drug|melphalan|
16373804|NCT00008229|Procedure|peripheral blood stem cell transplantation|
16373805|NCT00008229|Radiation|holmium Ho 166 DOTMP|
16373806|NCT00008073|Drug|doxorubicin hydrochloride|
16373807|NCT00008073|Drug|octreotide acetate|
16373808|NCT00006344|Radiation|radiation therapy|
16373809|NCT00006269|Drug|irinotecan hydrochloride|
16373810|NCT00006269|Drug|octreotide acetate|
16373811|NCT00003614|Drug|estramustine phosphate sodium|
16373812|NCT00003614|Drug|paclitaxel|
16373813|NCT00003523|Drug|aminocamptothecin colloidal dispersion|
16373814|NCT00003518|Drug|gemcitabine hydrochloride|
16373815|NCT00003518|Drug|paclitaxel|
16373816|NCT00003444|Biological|recombinant interferon alfa|
16373817|NCT00003444|Radiation|radiation therapy|
16373818|NCT00003405|Biological|recombinant interferon alfa|
16373819|NCT00003405|Drug|amifostine trihydrate|
16373820|NCT00003405|Drug|bromodeoxyuridine|
16373821|NCT00003405|Drug|cytarabine|
16373822|NCT00003405|Drug|idarubicin|
16373823|NCT00003405|Drug|idoxuridine|
16373824|NCT00003405|Drug|isotretinoin|
16373825|NCT00003405|Drug|mitoxantrone hydrochloride|
16373826|NCT00003403|Drug|GPX-100|
16373827|NCT00003269|Biological|sargramostim|
16373828|NCT00003269|Drug|amifostine trihydrate|
16373829|NCT00003269|Drug|cisplatin|
16373830|NCT00003269|Drug|cyclophosphamide|
16373831|NCT00003269|Drug|etoposide|
16373832|NCT00003195|Biological|recombinant interferon alfa|
16373833|NCT00003195|Drug|busulfan|
16374097|NCT00003423|Drug|thioguanine|
16373834|NCT00003195|Procedure|allogeneic bone marrow transplantation|
16373835|NCT00003195|Procedure|peripheral blood stem cell transplantation|
16373836|NCT00003195|Radiation|radiation therapy|
16373837|NCT00003187|Biological|filgrastim|
16373838|NCT00003187|Drug|cyclophosphamide|
16373839|NCT00003187|Drug|cyclosporine|
16373840|NCT00003187|Drug|cytarabine|
16373841|NCT00003187|Drug|methotrexate|
16373842|NCT00003187|Drug|methylprednisolone|
16373843|NCT00003187|Procedure|allogeneic bone marrow transplantation|
16373844|NCT00003187|Procedure|in vitro-treated bone marrow transplantation|
16373845|NCT00003187|Radiation|radiation therapy|
16373846|NCT00003098|Other|fat reduction with increased fiber|Patients are randomized to dietary fat reduction with increased fiber. All patient must successfully complete a dietary run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study.
16373847|NCT00003098|Other|fat reduction without increased fiber|Patients are randomized to dietary fat reduction without increased fiber. All patient must successfully complete a dietary run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study.
16373848|NCT00003084|Drug|Doxorubicin Hydrochloride|Doxorubicin IV on days 1, 15, and 29.
16373849|NCT00003084|Drug|Estramustine phosphate sodium|"Arm I: Oral estramustine three times a day for 21 day cycle.
~Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle."
16373850|NCT00003084|Drug|Etoposide|Oral etoposide twice daily on days 1-14.
16373851|NCT00003084|Drug|Ketoconazole|Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.
16373852|NCT00003084|Drug|Paclitaxel|IV over 1 hour on day 2.
16373853|NCT00003084|Drug|Vinblastine|IV on days 8, 22, and 36.
16373854|NCT00003056|Drug|cyclosporine|
16373855|NCT00003056|Drug|cyclosporine and methotrexate|
16373856|NCT00003004|Drug|alvocidib|
16373857|NCT00003004|Drug|cisplatin|
16373858|NCT00003004|Drug|paclitaxel|
16373859|NCT00002924|Other|mutation analysis|
16373860|NCT00002902|Drug|irinotecan hydrochloride|
16373861|NCT00002902|Drug|raltitrexed|
16373862|NCT00002875|Biological|filgrastim|
16373863|NCT00002875|Drug|cisplatin|
16373864|NCT00002875|Drug|cyclophosphamide|
16373865|NCT00002875|Drug|lomustine|
16373866|NCT00002875|Drug|mesna|
16373867|NCT00002875|Drug|vincristine sulfate|
16373868|NCT00002875|Radiation|low-LET electron therapy|
16373869|NCT00002875|Radiation|low-LET photon therapy|
16373870|NCT00002780|Biological|aldesleukin|
16373871|NCT00002780|Biological|cytokine therapy|
16373872|NCT00002780|Biological|sargramostim|
16373873|NCT00002780|Drug|carboplatin|
16373874|NCT00002780|Drug|cyclophosphamide|
16373875|NCT00002780|Drug|thiotepa|
16373876|NCT00002780|Procedure|peripheral blood stem cell transplantation|
16373877|NCT00002750|Drug|melphalan|
16373878|NCT00002734|Biological|recombinant interferon alfa|
16373879|NCT00002734|Drug|chemotherapy|
16373880|NCT00002734|Drug|paclitaxel|
16373881|NCT00002734|Drug|topotecan hydrochloride|
16373882|NCT00002734|Radiation|lutetium Lu 177 monoclonal antibody CC49|
16373883|NCT00002734|Radiation|yttrium Y 90 monoclonal antibody CC49|
16373884|NCT00002671|Drug|aminocamptothecin|
16373885|NCT00002664|Biological|edrecolomab|
16373886|NCT00002664|Biological|sargramostim|
16373887|NCT00002576|Drug|cyclophosphamide|
16373888|NCT00002576|Drug|doxorubicin hydrochloride|
16373889|NCT00002576|Drug|mitoxantrone hydrochloride|
16373890|NCT00002576|Drug|prednisolone|
16373891|NCT00002576|Drug|vincristine sulfate|
16373892|NCT00002571|Biological|bleomycin sulfate|5u/m2 IV Q21days x 6 cycles
16373893|NCT00002571|Biological|filgrastim|5ug/kg SC, Days 9-20, Q 21 days x 6 cycles
16373894|NCT00002571|Drug|cyclophosphamide|490 mg/m2 IV Q 21 days x 6 cycles
16373895|NCT00002571|Drug|cytarabine|225 mg/m2 IV Q 21 days x 6 cycles
16373896|NCT00002571|Drug|doxorubicin hydrochloride|19 mg/m2 IV Q 21 days x 6 cycles
16373897|NCT00002571|Drug|etoposide|90 mg/m2 IV Q 21 days x 6 cycles
16373898|NCT00002571|Drug|leucovorin calcium|25 mg/m2 po 24 hours after methotrexate Q 6 hours x 4 doses for 6 cycles.
16373899|NCT00002571|Drug|methotrexate|90 mg/m2 IV, Q 21 days x 6 cycles.
16373900|NCT00002571|Drug|prednisone|60 mg/m2 po QD x 14days for 6 cycles
16373901|NCT00002571|Drug|trimethoprim-sulfamethoxazole|1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles
16373902|NCT00002571|Drug|vincristine sulfate|1.4 mg/m2 IV Q 21 Days x 6 cycles
16373903|NCT00002571|Radiation|radiation therapy|All patients achieving a CR or PR following systemic therapy and IT Ara-C, will receive 2,400 cGy in two hundred cGy fractions to the whole brain. Fields should adequately encompass all meningeal surfaces.
16373994|NCT00002707|Drug|Tamoxifen|20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
16373995|NCT00002692|Drug|fluorouracil|
16373996|NCT00002692|Drug|isolated perfusion|
16373997|NCT00002692|Drug|leucovorin calcium|
16373904|NCT00002571|Drug|Intrathecal cytarabine|"If initial bone marrow positive:
~Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first two cycles of therapy. Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle.
~If initial CSF cytology positive:
~Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first cycle of therapy. If CSF negative after above, Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If CSF positive after initial five doses of Ara-C, IT MTX 12 mg per dose x 5 doses should be given spaced evenly during the second cycle of therapy.
~If initial bone marrow and CSF negative:
~Ara-C 30 mg/m2 IT per dose x 5 doses to be given spaced evenly within 1 month of completion of systemic therapy."
16373905|NCT00002567|Biological|filgrastim|
16373906|NCT00002567|Drug|etoposide|
16373907|NCT00002567|Procedure|peripheral blood stem cell transplantation|
16373908|NCT00002567|Radiation|low-LET electron therapy|
16373909|NCT00002567|Radiation|low-LET photon therapy|
16373910|NCT00002552|Biological|filgrastim|
16373911|NCT00002552|Biological|sargramostim|
16373912|NCT00002552|Drug|carmustine|
16373913|NCT00002552|Drug|cyclophosphamide|
16373914|NCT00002552|Drug|cytarabine|
16373915|NCT00002552|Drug|etoposide|
16373916|NCT00002552|Drug|leucovorin calcium|
16373917|NCT00002552|Drug|methotrexate|
16373918|NCT00002552|Drug|perfosfamide|
16373919|NCT00002552|Drug|therapeutic hydrocortisone|
16373920|NCT00002552|Procedure|allogeneic bone marrow transplantation|
16373921|NCT00002552|Procedure|autologous bone marrow transplantation|
16373922|NCT00002552|Procedure|in vitro-treated bone marrow transplantation|
16373923|NCT00002552|Procedure|peripheral blood stem cell transplantation|
16373924|NCT00002552|Procedure|syngeneic bone marrow transplantation|
16373925|NCT00002552|Radiation|radiation therapy|
16373926|NCT00002547|Drug|busulfan|
16373927|NCT00002547|Drug|cyclophosphamide|
16373928|NCT00002547|Drug|cyclosporine|
16373929|NCT00002547|Drug|cytarabine|
16373930|NCT00002547|Drug|methotrexate|
16373931|NCT00002547|Procedure|allogeneic bone marrow transplantation|
16373932|NCT00002547|Procedure|syngeneic bone marrow transplantation|
16373933|NCT00083356|Procedure|Wisdom tooth extraction|
16373934|NCT00005648|Drug|Gemcitabine with R115777|R115777 200 mg, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
16373935|NCT00005648|Drug|Gemcitabine with Placebo|Placebo, oral, twice daily at 12-hour intervals throughout the study coadministered with gemcitabine, 1000 mg/m2, iv, every week for the first 7 weeks, followed by 1 week rest, and then every 3 out of 4 weeks thereafter for up to 5 years
16373936|NCT00004198|Biological|keyhole limpet hemocyanin|
16373937|NCT00004198|Biological|sargramostim|
16373938|NCT00004198|Biological|tumor cell-based vaccine therapy|
16373939|NCT00004126|Drug|oxaliplatin|
16373940|NCT00004126|Drug|paclitaxel|
16373941|NCT00004122|Biological|BCG vaccine|
16373942|NCT00004122|Biological|recombinant interferon alfa|
16373943|NCT00004113|Drug|temozolomide|
16373944|NCT00003976|Drug|indisulam|
16373945|NCT00003908|Drug|carboplatin|
16373946|NCT00003908|Drug|docetaxel|
16373947|NCT00003822|Drug|apomine|
16373948|NCT00003747|Drug|carboplatin|
16373949|NCT00003747|Drug|temozolomide|
16373950|NCT00003724|Procedure|surgical procedure|
16373951|NCT00003670|Drug|arzoxifene hydrochloride|
16373952|NCT00003606|Drug|cisplatin|
16373953|NCT00003606|Drug|cyclophosphamide|
16373954|NCT00003606|Drug|epirubicin hydrochloride|
16373955|NCT00003606|Drug|etoposide|
16373956|NCT00003606|Radiation|radiation therapy|
16373957|NCT00003562|Drug|carboplatin|
16373958|NCT00003562|Drug|docetaxel|
16373959|NCT00003490|Biological|sargramostim|
16373960|NCT00003490|Drug|cyclophosphamide|
16373961|NCT00003490|Drug|prednisone|
16373962|NCT00003490|Drug|vincristine sulfate|
16373963|NCT00003447|Drug|gemcitabine hydrochloride|
16373964|NCT00003447|Drug|vinorelbine tartrate|
16373965|NCT00003365|Dietary Supplement|curcumin|
16373966|NCT00003365|Dietary Supplement|rutin|
16373967|NCT00003365|Drug|quercetin|
16373968|NCT00003365|Drug|sulindac|
16373969|NCT00003322|Drug|cisplatin|
16373970|NCT00003322|Drug|paclitaxel|
16373971|NCT00003322|Procedure|quality-of-life assessment|
16373972|NCT00003289|Drug|7-hydroxystaurosporine|
16373973|NCT00003250|Drug|fenretinide|
16373974|NCT00003101|Biological|filgrastim|
16373975|NCT00003101|Drug|busulfan|
16373976|NCT00003101|Drug|lomustine|
16373977|NCT00003101|Drug|procarbazine hydrochloride|
16373978|NCT00003101|Drug|thiotepa|
16373979|NCT00003101|Drug|vincristine sulfate|
16373980|NCT00003101|Procedure|autologous bone marrow transplantation|
16373981|NCT00003101|Procedure|peripheral blood stem cell transplantation|
16373982|NCT00002880|Drug|Etoposide phosphate|50 mg PO q day for 21 days; repeat every 28 days escalate dose to 100 mg PO q day if ANC remains greater than 1500/microliter during cycle 1: no specified maximum of cycles if PR or CR
16373983|NCT00002876|Drug|cisplatin|
16373984|NCT00002876|Drug|etoposide|
16373985|NCT00002813|Drug|cisplatin|
16373986|NCT00002813|Drug|vinorelbine tartrate|
16373987|NCT00002787|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|Given SC
16373988|NCT00002787|Biological|sargramostim|Given SC
16373989|NCT00002787|Biological|aldesleukin|Given SC
16373990|NCT00002787|Other|laboratory biomarker analysis|Correlative studies
16373991|NCT00002707|Drug|Cyclophosphamide|600 mg/m2 IV every 21 days for 4 cycles
16373992|NCT00002707|Drug|Docetaxel|100 mg/m2 IV every 21 days for 4 cycles
16373993|NCT00002707|Drug|Doxorubicin|60 mg/m2 IV every 21 days fo 4 cycles
16374095|NCT00003423|Drug|methotrexate|
16373998|NCT00002673|Procedure|infection prophylaxis and management|
16373999|NCT00002599|Biological|filgrastim|
16374000|NCT00002599|Biological|recombinant interferon alfa|
16374001|NCT00002599|Biological|sargramostim|
16374002|NCT00002599|Drug|carmustine|
16374003|NCT00002599|Drug|cyclophosphamide|
16374004|NCT00002599|Drug|doxorubicin hydrochloride|
16374005|NCT00002599|Drug|melphalan|
16374006|NCT00002599|Drug|methylprednisolone|
16374007|NCT00002599|Drug|prednisone|
16374008|NCT00002599|Drug|vincristine sulfate|
16374009|NCT00002599|Radiation|low-LET cobalt-60 gamma ray therapy|
16374010|NCT00002599|Radiation|low-LET photon therapy|
16374011|NCT00083330|Drug|VRC-HIVADV014-00-VP|
16374012|NCT00083278|Drug|MDX-010|
16374013|NCT00012350|Drug|FTI|
16374014|NCT00010088|Drug|fluorouracil|
16374015|NCT00010088|Drug|gemcitabine hydrochloride|
16374016|NCT00010088|Drug|leucovorin calcium|
16374017|NCT00010088|Procedure|conventional surgery|
16374018|NCT00010088|Radiation|radiation therapy|
16374019|NCT00006220|Drug|arsenic trioxide|
16374020|NCT00006220|Drug|tretinoin|
16374021|NCT00005814|Biological|cetuximab|
16374022|NCT00005814|Drug|cisplatin|
16374023|NCT00005814|Radiation|radiation therapy|
16374024|NCT00005581|Drug|cyclophosphamide|
16374025|NCT00005581|Drug|epirubicin hydrochloride|
16374026|NCT00005581|Drug|fluorouracil|
16374027|NCT00005581|Drug|paclitaxel|
16374028|NCT00004880|Biological|dendritic cell vaccine therapy|
16374029|NCT00004880|Procedure|conventional surgery|
16374030|NCT00004211|Biological|PSA RNA-pulsed dendritic cell vaccine|
16374031|NCT00004156|Biological|MUC1-KLH vaccine/QS21|
16374032|NCT00004132|Biological|filgrastim|
16374033|NCT00004132|Biological|palifermin|
16374034|NCT00004132|Drug|cyclophosphamide|
16374035|NCT00004132|Drug|etoposide|
16374036|NCT00004132|Drug|ifosfamide|
16374037|NCT00004132|Procedure|quality-of-life assessment|
16374038|NCT00004132|Radiation|radiation therapy|
16374039|NCT00004073|Drug|suramin|
16374040|NCT00004073|Radiation|radiation therapy|
16374041|NCT00004056|Biological|filgrastim|
16374042|NCT00004056|Drug|asparaginase|
16374043|NCT00004056|Drug|cytarabine|
16374044|NCT00004056|Drug|daunorubicin hydrochloride|
16374045|NCT00004056|Drug|melphalan|
16374046|NCT00004056|Drug|thioguanine|
16374047|NCT00004056|Procedure|peripheral blood stem cell transplantation|
16374048|NCT00004051|Drug|irinotecan hydrochloride|
16374049|NCT00004038|Biological|Ad5CMV-p53 gene|
16374050|NCT00004038|Drug|chemotherapy|
16374051|NCT00003924|Biological|recombinant interferon alfa|
16374052|NCT00003876|Drug|polifeprosan 20 with carmustine implant|
16374053|NCT00003876|Procedure|surgical procedure|
16374054|NCT00003876|Radiation|iodine I 125|
16374055|NCT00003801|Procedure|management of therapy complications|
16374056|NCT00003801|Procedure|quality-of-life assessment|
16374057|NCT00003731|Drug|temozolomide|
16374058|NCT00003700|Biological|G-CSF|Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC > 5,000 uL after nadir: 7 day minimum for Courses I & IV
16374059|NCT00003700|Drug|asparaginase|6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I & IV
16374060|NCT00003700|Drug|cyclophosphamide|1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I & IV (pts < 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II & V
16374061|NCT00003700|Drug|cytarabine|2000 mg/sq m IV infusion over 3 hrs Days 1,2, & 3: Courses II & V
16374062|NCT00003700|Drug|daunorubicin hydrochloride|80mg/sq m (pts<60y/o)OR 60mg/sq m (pts =/>60y/o) IV infusion over 5-10 min Days 1,2,& 3: Courses I & IV
16374063|NCT00003700|Drug|leucovorin calcium|"Courses III & VI:
~25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX <0.05 uM after ea IV dose"
16374064|NCT00003700|Drug|mercaptopurine|60mg/sq m/d PO every day Course VII
16374065|NCT00003700|Drug|methotrexate|15mg intrathecal Day 1 Courses II & V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, & 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III & VI.
16374066|NCT00003700|Drug|prednisone|60mg/sq m/day PO Days 1-21 (pts<60y/o) OR Days 1-7 (pts >/= 60y/o) Courses I & IV and Days 1-5 of ea 4 cycle in Course VII
16374067|NCT00003700|Drug|vincristine sulfate|2 mg total IV infusion Days 1,8,15,& 22 Courses I & IV and Days 1, 8, & 15 Courses III & VI, and Day 1 of ea 4 wk cycle in Course VII
16374068|NCT00003700|Drug|Allopurinol|300mg PO q day Days 1-14 Course I
16374069|NCT00003698|Drug|fosbretabulin disodium|
16374070|NCT00003697|Drug|vadimezan|
16374071|NCT00003685|Procedure|fatigue assessment and management|
16374072|NCT00003685|Procedure|nausea and vomiting therapy|
16374073|NCT00003685|Procedure|pain therapy|
16374074|NCT00003685|Procedure|quality-of-life assessment|
16374075|NCT00003685|Radiation|radiation therapy|
16374076|NCT00003640|Biological|filgrastim|
16374077|NCT00003640|Drug|cisplatin|
16374078|NCT00003640|Drug|doxorubicin hydrochloride|
16374079|NCT00003640|Drug|methotrexate|
16374080|NCT00003640|Drug|vinblastine sulfate|
16374081|NCT00003640|Procedure|surgical procedure|
16374082|NCT00003640|Radiation|radiation therapy|
16374083|NCT00003575|Biological|filgrastim|
16374084|NCT00003575|Biological|recombinant interleukin-12|
16374085|NCT00003575|Drug|etoposide|
16374086|NCT00003575|Drug|ifosfamide|
16374087|NCT00003439|Biological|recombinant interleukin-12|
16374088|NCT00003423|Drug|asparaginase|
16374089|NCT00003423|Drug|cyclophosphamide|
16374090|NCT00003423|Drug|cytarabine|
16374091|NCT00003423|Drug|daunorubicin hydrochloride|
16374092|NCT00003423|Drug|dexamethasone|
16374093|NCT00003423|Drug|etoposide|
16374094|NCT00003423|Drug|mercaptopurine|
16374098|NCT00003423|Drug|vincristine sulfate|
16374099|NCT00003330|Biological|recombinant interleukin-12|
16374100|NCT00003326|Drug|paclitaxel|
16374101|NCT00003255|Drug|carboplatin|
16374102|NCT00003255|Drug|topotecan hydrochloride|
16374103|NCT00002578|Drug|cytarabine|
16374104|NCT00002578|Drug|gallium nitrate|
16374105|NCT00002578|Drug|leucovorin calcium|
16374106|NCT00002578|Drug|methotrexate|
16374107|NCT00002503|Radiation|strontium chloride Sr 89|
16374108|NCT00083304|Drug|Efaproxiral|"75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).
~Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days."
16374109|NCT00083304|Radiation|Whole Brain Radiation Therapy (WBRT)|3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
16374110|NCT00083304|Other|Supplemental Oxygen|"4 L/minute by nasal cannula.
~Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days."
16374111|NCT00083213|Biological|ziv-aflibercept|
16374112|NCT00082940|Biological|denileukin diftitox|
16374113|NCT00082927|Drug|ibandronate sodium|
16374114|NCT00082914|Biological|denileukin diftitox|
16374115|NCT00082888|Other|Laboratory Biomarker Analysis|Correlative studies
16374116|NCT00082888|Drug|Tipifarnib|Given PO
16374117|NCT00082875|Drug|cilengitide|Given IV
16374118|NCT00082875|Other|pharmacological study|Correlative studies
16374119|NCT00082875|Other|laboratory biomarker analysis|Correlative studies
16374120|NCT00082862|Biological|recombinant interferon alfa|
16374121|NCT00082862|Drug|cisplatin|
16374122|NCT00082862|Drug|gemcitabine hydrochloride|
16374123|NCT00082862|Procedure|hyperthermia treatment|
16374124|NCT00082836|Biological|rituximab|
16374125|NCT00082836|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16374126|NCT00082823|Biological|ziv-aflibercept|
16374127|NCT00082810|Drug|fulvestrant|Given intramuscularly
16374128|NCT00082810|Drug|tipifarnib|Given IV
16374129|NCT00082797|Drug|leucovorin calcium|
16374130|NCT00082797|Drug|methotrexate|
16374131|NCT00082784|Drug|Bortezomib|Given IV
16374132|NCT00082784|Drug|Alvocidib Hydrochloride|Given IV
16374133|NCT00082784|Other|Pharmacological Study|Correlative studies
16374134|NCT00082758|Biological|hu14.18-Interleukin-2 fusion protein|Given IV
16374135|NCT00082745|Other|Laboratory Biomarker Analysis|Correlative studies
16374136|NCT00082745|Other|Questionnaire Administration|Ancillary studies
16374137|NCT00082732|Behavioral|behavioral dietary intervention|
16374138|NCT00082732|Dietary Supplement|dietary intervention|
16374139|NCT00082732|Procedure|therapeutic dietary intervention|
16374140|NCT00082719|Biological|Recombinant Interferon Alfa|"In all arms, treatment begins at pre-operative visit and continues until cystoscopy.
~Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose."
16374141|NCT00082706|Drug|5-Fluorouracil (5-FU)|Day: 1 - 5 Dose: 200 mg/m2 IVCI daily x 5 days
16374142|NCT00082706|Drug|Leucovorin|Day: 1 - 5 Dose:10 mg/m2 daily x 5 days
16374143|NCT00082706|Drug|Cisplatin|Day: 1 - 5 Dose: 20 mg/m2 daily x 5 days
16374144|NCT00082706|Drug|Gemcitabine|Day: 1 & 5 Dose: 200 mg/m2 (Two doses only)
16374145|NCT00082667|Drug|gefitinib|
16374146|NCT00082667|Procedure|Surgery|
16374147|NCT00082654|Procedure|psychosocial assessment and care|
16374148|NCT00082641|Biological|autologous dendritic cell-adenovirus p53 vaccine|Given subcutaneously on one of two schedules
16374149|NCT00003186|Drug|isosulfan blue|
16374150|NCT00003186|Procedure|lymphangiography|
16374151|NCT00003186|Procedure|sentinel lymph node biopsy|
16374152|NCT00003183|Biological|filgrastim|
16374153|NCT00003183|Drug|mitoxantrone hydrochloride|
16374154|NCT00003154|Drug|aminocamptothecin colloidal dispersion|120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.
16374155|NCT00003118|Drug|cisplatin|
16374156|NCT00003118|Drug|fluorouracil|
16374157|NCT00003118|Procedure|surgical procedure|
16374158|NCT00003118|Radiation|radiation therapy|
16374159|NCT00003117|Drug|carboplatin|
16374160|NCT00003117|Drug|paclitaxel|
16374161|NCT00003020|Biological|LMB-7 immunotoxin|
16374162|NCT00002988|Drug|carmustine|
16374163|NCT00002988|Drug|irinotecan hydrochloride|
16374164|NCT00002985|Drug|daunorubicin hydrochloride|
16374165|NCT00002985|Drug|pegylated liposomal doxorubicin hydrochloride|
16374166|NCT00002961|Drug|cyclophosphamide|Arms A and B Day 2 and 3: Cyclophosphamide 60 mg/kg intravenously; Administer 20 mg/ml concentration over 2 hours.
16374167|NCT00002961|Drug|cyclosporine|"graft vs. host disease (GVHD)prophylaxis: starting on day-1, cyclosporin 1.5 mg/kg IV every 12 hours or by continuous infusion.
~When the patient tolerates adequate oral intake, cyclosporin therapy may be changed from IV to oral administration. Cyclosporin therapy should be continued at full dose until day +50. if the patient has less than Grade 2 GVHD, cyclosporin may be tapered by 5-10% weekly until completely off cyclosporin therapy."
16374168|NCT00002961|Drug|etoposide|Day 4 (arms A/B): 40 mg/kg over four hours intravenously
16374169|NCT00002961|Drug|methotrexate|"methotrexate 15 mg/m2 IV on day +1 (do not give until 24 hours after marrow infusion), and 10mg/mg2 IV on days +3 and +6.
~Methotrexate may be held after two doses for bilirubin .2 mg/dL. If serum creatinine is >2x baseline, methotrexate will be omitted. If the presence of ascites or pleural effusion, methotrexate will be omitted."
16374170|NCT00002961|Procedure|allogeneic bone marrow transplantation|Bone marrow infusion given on day 0
16374246|NCT00002936|Drug|altretamine|
16374247|NCT00002936|Drug|etoposide|
16374248|NCT00002903|Drug|docetaxel|
16374171|NCT00002961|Radiation|Total Body Irradiation|Day 0: Marrow Transfusion; Day 1: rest; Day 2 and 3: Cyclophosphamide 60 mg/kg; Day 4: Etopophos 40 mg/kg over four hours; Day 5,6 and 7: Total Body Irradiation (TBI) [200 cGy twice a day (BID)].
16374172|NCT00002961|Drug|Busulfan|"Conditioning Regimen Arm B:
~Day 0: Marrow infusion; Day 1: Rest; Day 2 and 3: Cyclophosphamide 60 mg/kg; Day 4: Etopophos 40 mg/kg over four hours; Day 5,6,7 and 8: Busulfan 0.8 mg/kg intravenous (IV) every 6 hours x 4 doses.
~Patients </= 20kg to receive busulfan 1.0 mg/kg/dose IV**Busulfan oral preparation may be substituted: 1mg/kg/dose by mouth (po) for patients >20kg and 1.25 mg/kg/dose by mouth (po) for patients </= 20 kg."
16374173|NCT00002961|Drug|Mesna|Dosing per institutional preference for hemorrhagic cystitis. Mesna 300 mg/m2 as a 15 minute infusion prior to each dose of cyclophosphamide, then at 3,6,9,12, 18 and 21 hours after initiation of each cyclophosphamide infusion. Alternative method of Mesna administration is 10 mg/kg prior to cyclophosphamide and 100 mg/kg/24 hours by continuous infusion.
16374174|NCT00002961|Radiation|Radiation|"Central Nervous System (CNS) therapy:
~a) CNS Leukemia prior to study entry: No TBI i) No prior CNS irradiation: 2340 centigray (cGy) in 13 fractions of 180 cGy to the cranial field and 600 cGy in 200 cGy fractions to the spinal field prior to conditioning. II) >/= 1800 cGy prior CNS irradiation: 1800 cGy to cranial field and 600 cGy spinal prior to conditioning. If prior radiation therapy (RT) doses >3000 cGy have been administered or CNS Leukemia prior to study entry: TBI, consult with Principal Investigator (PI). Recommend: 1) no prior CNS irradiation: 600 cGy in 3 fractions to the cranial field prior to conditioning or overlapping with TBI.
~Testicular Boost Irradiation: a) overt testicular leukemia at relapse: No TBI 2400 cGy in 12 fractions prior to conditioning; b) overt testicular leukemia at relapse: TBI 1200 cGy in 6 fractions over 8-10 days prior to conditioning. c) No overt testicular leukemia: 200 cGy first and last fractions of TBI-"
16374175|NCT00083252|Drug|talabostat (PT-100) tablets|
16374176|NCT00083252|Drug|cisplatin|
16374177|NCT00083239|Drug|talabostat (PT-100) tablets|
16374178|NCT00083226|Drug|doxorubicin|Given IV
16374179|NCT00083226|Drug|bortezomib|Given IV
16374180|NCT00083187|Drug|hydroxyurea|
16374181|NCT00083187|Drug|laromustine|
16374182|NCT00083174|Drug|exemestane|one 25 mg tablet daily in am
16374183|NCT00083161|Drug|cisplatin|60 mg/m2 IV day 1, every 21 days for 4 cycles.
16374184|NCT00083161|Drug|cyclophosphamide|25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression
16374185|NCT00083161|Drug|etoposide|120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
16374186|NCT00083148|Drug|capecitabine|
16374187|NCT00083148|Drug|irinotecan hydrochloride|
16374188|NCT00083135|Biological|filgrastim|
16374189|NCT00083135|Procedure|autologous bone marrow transplantation|
16374190|NCT00083135|Procedure|peripheral blood stem cell transplantation|
16374191|NCT00083135|Radiation|iobenguane I 131|
16374192|NCT00083122|Drug|cisplatin|Given IV
16374193|NCT00083122|Drug|alvocidib|Given IV
16374194|NCT00083122|Drug|cisplatin/flavopiridol|Given IV
16374195|NCT00083109|Drug|Fluorouracil|Given IV
16374196|NCT00083109|Other|Pharmacological Study|Correlative studies
16374197|NCT00083109|Drug|Suramin|Given IV
16374198|NCT00083096|Drug|lonafarnib|
16374199|NCT00083096|Drug|temozolomide|
16374200|NCT00083083|Drug|carboplatin|
16374201|NCT00083083|Drug|cisplatin|
16374202|NCT00083083|Drug|docetaxel|
16374203|NCT00083083|Drug|etoposide|
16374204|NCT00083083|Drug|paclitaxel|
16374205|NCT00083083|Drug|vinblastine sulfate|
16374206|NCT00083083|Drug|vinorelbine tartrate|
16374207|NCT00083083|Genetic|gene expression analysis|
16374208|NCT00083083|Procedure|positron emission tomography|
16374209|NCT00083083|Radiation|fludeoxyglucose F 18|
16374210|NCT00083083|Radiation|radiation therapy|
16374211|NCT00083070|Drug|temozolomide|
16374212|NCT00083057|Drug|gefitinib|
16374213|NCT00083057|Drug|paclitaxel|
16374214|NCT00083057|Radiation|radiation therapy|
16374215|NCT00083031|Drug|bevacizumab|
16374216|NCT00083031|Drug|cyclophosphamide|
16374217|NCT00083031|Drug|methotrexate|
16374218|NCT00083018|Genetic|cytogenetic analysis|
16374219|NCT00083018|Genetic|proteomic profiling|
16374220|NCT00083018|Other|cytology specimen collection procedure|
16374221|NCT00083018|Other|immunohistochemistry staining method|
16374222|NCT00083018|Other|laboratory biomarker analysis|
16374223|NCT00083018|Procedure|breast duct lavage|
16374224|NCT00083005|Drug|docetaxel|
16374225|NCT00083005|Drug|estramustine phosphate sodium|
16374226|NCT00083005|Drug|thalidomide|
16374227|NCT00082979|Genetic|cytogenetic analysis|
16374228|NCT00082979|Genetic|proteomic profiling|
16374229|NCT00082979|Other|cytology specimen collection procedure|
16374230|NCT00082979|Other|immunohistochemistry staining method|
16374231|NCT00082979|Other|laboratory biomarker analysis|
16374232|NCT00082979|Procedure|breast duct lavage|
16374233|NCT00082966|Drug|17-N-allylamino-17-demethoxygeldanamycin/bortezomib|Given IV
16374234|NCT00082628|Drug|Placebo|Placebo matched to serostim® as subcutaneous injection.
16374235|NCT00082628|Drug|Serostim® 4 mg|Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.
16374236|NCT00082628|Drug|Serostim® 2 mg|Serostim® 2 mg as subcutaneous injection on alternate days.
16374237|NCT00082602|Drug|galantamine ER|
16374238|NCT00082589|Drug|Eplerenone|
16374239|NCT00082576|Drug|Azithromycin/Chloroquine|
16374240|NCT00082576|Drug|Mefloquine|
16374241|NCT00082563|Drug|Azithromycin/Chloroquine|
16374242|NCT00082563|Drug|Chloroquine|
16374243|NCT00082537|Drug|caspofungin acetate|Duration of Treatment: 28-90 days
16374244|NCT00082537|Drug|Comparator: AmBisome|Duration of Treatment: 28-90 days
16374245|NCT00082524|Drug|caspofungin acetate|Duration of Treatment - 7-90 days
16374249|NCT00002896|Drug|chemotherapy|
16374250|NCT00002896|Drug|fluorouracil|
16374251|NCT00002896|Drug|leucovorin calcium|
16374252|NCT00002896|Procedure|conventional surgery|
16374253|NCT00002896|Radiation|low-LET cobalt-60 gamma ray therapy|
16374254|NCT00002896|Radiation|low-LET photon therapy|
16374255|NCT00002893|Drug|fluorouracil|
16374256|NCT00002893|Drug|leucovorin calcium|
16374257|NCT00002893|Drug|raltitrexed|
16374258|NCT00002892|Biological|recombinant interferon alfa|
16374259|NCT00082498|Drug|SCH-D (vicriviroc)|Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment.
16374260|NCT00082498|Drug|Placebo|Patients in Group 1 will receive placebo.
16374261|NCT00082485|Drug|Baclofen|Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
16374262|NCT00082485|Other|Placebo|Placebo
16374263|NCT00082472|Drug|Doxorubicin HCl Inhalation Solution|
16374264|NCT00082472|Drug|Docetaxel|
16374265|NCT00082472|Drug|Cisplatin|
16374266|NCT00082459|Biological|autologous human tumor-derived HSPPC-96|
16374267|NCT00002870|Biological|filgrastim|
16374268|NCT00002870|Drug|cyclophosphamide|
16374269|NCT00002870|Drug|epirubicin hydrochloride|
16374270|NCT00002870|Drug|fluorouracil|
16374271|NCT00002870|Drug|thiotepa|
16374272|NCT00002870|Procedure|peripheral blood stem cell transplantation|
16374273|NCT00002826|Drug|paclitaxel|
16374274|NCT00002826|Drug|valspodar|
16374275|NCT00002803|Drug|cyclophosphamide|
16374276|NCT00002803|Drug|doxorubicin hydrochloride|
16374277|NCT00002803|Drug|vincristine sulfate|
16374278|NCT00002803|Procedure|conventional surgery|
16374279|NCT00002802|Drug|carboplatin|
16374280|NCT00002802|Drug|cisplatin|
16374281|NCT00002802|Drug|cyclophosphamide|
16374282|NCT00002802|Drug|dacarbazine|
16374283|NCT00002802|Drug|doxorubicin hydrochloride|
16374284|NCT00002802|Drug|etoposide|
16374285|NCT00002802|Drug|ifosfamide|
16374286|NCT00002802|Drug|melphalan|
16374287|NCT00002802|Drug|mesna|
16374288|NCT00002802|Drug|vincristine sulfate|
16374289|NCT00002802|Drug|vindesine|
16374290|NCT00002802|Procedure|autologous bone marrow transplantation|
16374291|NCT00002802|Procedure|conventional surgery|
16374292|NCT00002802|Radiation|low-LET cobalt-60 gamma ray therapy|
16374293|NCT00002802|Radiation|low-LET electron therapy|
16374294|NCT00002802|Radiation|low-LET photon therapy|
16374295|NCT00002802|Radiation|radioisotope therapy|
16374296|NCT00082446|Biological|Live vaccinia virus vaccine|Dryvax®: 0.25 mL of vaccine will be administered by the standard route of scarification using a bifurcated needle on day 112 for Groups A, B, C, D and F.
16374297|NCT00082446|Biological|MVA Smallpox Vaccine|Imvamune/MVA-BN 1x10^8 will be administered intramuscularly to Group F on day 0 and day 28.
16374298|NCT00082446|Biological|MVA Smallpox Vaccine|Imvamune/MVA-BN Groups A, B C and E will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8, 1x10^8, respectively, on days 0 and day 28.
16374299|NCT00082446|Other|Placebo|Group E will receive sterile saline placebo for injection via scarification on day 112.
16374300|NCT00082446|Other|Placebo|Group D will receive sterile saline placebo for injection subcutaneously on day 0 and day 28.
16374301|NCT00082433|Drug|Ixabepilone + Capecitabine|Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
16374302|NCT00082433|Drug|Capecitabine|Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
16374303|NCT00082381|Drug|Exenatide (AC2993)|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
16374304|NCT00082381|Drug|Insulin glargine|subcutaneous injection, once daily; forced titration to target blood glucose level
16374305|NCT00002788|Biological|filgrastim|
16374306|NCT00002788|Drug|cyclophosphamide|
16374307|NCT00002788|Drug|dexamethasone|
16374308|NCT00002788|Drug|etoposide|
16374309|NCT00002788|Procedure|peripheral blood stem cell transplantation|
16374310|NCT00002788|Radiation|radiation therapy|
16374311|NCT00002737|Biological|recombinant interferon alfa|
16374312|NCT00002737|Drug|chemotherapy|
16374313|NCT00002737|Drug|isotretinoin|
16374314|NCT00002677|Drug|chemotherapy|
16374315|NCT00002677|Drug|tributyrin|
16374316|NCT00002644|Drug|Tamoxifen Citrate 20Mg Tab|Tamoxifen Citrate 20Mg Tab
16374317|NCT00002644|Other|Placebo|Placebo 20Mg Tab
16374318|NCT00002587|Drug|paclitaxel|
16374319|NCT00002587|Drug|topotecan hydrochloride|
16374320|NCT00082407|Drug|exenatide|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
16374321|NCT00082407|Drug|biphasic insulin aspart|subcutaneous injection, twice daily; titration to target blood glucose level
16374322|NCT00082394|Drug|Trizivir|
16374323|NCT00082394|Drug|atazanavir|
16374324|NCT00082394|Drug|Combivir|
16374325|NCT00082316|Drug|Capsaicin Dermal Patch|
16374326|NCT00082368|Drug|Tariquidar|3 days after initial PET patients will receive tariquidar and repeat imaging.
16374327|NCT00082368|Drug|Tc-94m Sestamibi|Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI (National Cancer Institute) protocol for treatment of cancer will undergo a PET sestamibi scan
16374413|NCT00005612|Biological|filgrastim|
16374414|NCT00005612|Drug|carboplatin|
16374415|NCT00005612|Drug|cyclophosphamide|
16374416|NCT00005612|Drug|etoposide|
16374417|NCT00005612|Drug|paclitaxel|
16374328|NCT00082355|Drug|Alteplase (Activase, Genentech)|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 4 day period.
16374329|NCT00082342|Device|Phoressor II (IOMED)|sham stimulation
16374330|NCT00082342|Device|Phoressor II (IOMED)|real tDCS stimulation
16374331|NCT00082329|Drug|AMD 3100 (Mozobil plerixafor)|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.
16374332|NCT00082329|Drug|Granulocyte colony-stimulating factor (G-CSF)|Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.
16374333|NCT00082303|Behavioral|Music Imagery|
16374334|NCT00082290|Other|massage therapy|
16374335|NCT00082290|Other|visit with a volunteer|
16374336|NCT00082290|Other|period of quiet time|
16374337|NCT00082290|Behavioral|questionaire about pain|
16374338|NCT00082277|Drug|Anastrozole|1mg/Day Oral
16374339|NCT00082277|Drug|Risedronate Sodium|35mg/week, oral
16374340|NCT00082251|Drug|Niacin extended release and simvastatin tablets|
16374341|NCT00082238|Other|Stable isotopes|Stable isotopes were used to quantify gluconeogenesis GNG, hepatic glucose production (HGP), and protein breakdown.
16374342|NCT00082225|Biological|CD45 antibodies|The antibody solution is administered by a syringe pump in incremental doses, 0.2-0.8 mg in the first hour and up to 10 mg/hr thereafter, for a maximum infusion time of 8 hrs.
16374343|NCT00082225|Biological|EBV specific T cells|"The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules:
~2 x 10e7 cells/m2 5 x 10e7 cells/m2
~1 x 10e8 cells/m2"
16374344|NCT00082212|Biological|Cetuximab|400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
16374345|NCT00014651|Drug|vapreotide|
16374346|NCT00014651|Procedure|conventional surgery|
16374347|NCT00010322|Drug|atamestane|
16374348|NCT00010322|Drug|toremifene|
16374349|NCT00008255|Drug|INS316|
16374350|NCT00008255|Other|sputum cytology|
16374351|NCT00002568|Drug|cisplatin|
16374352|NCT00002568|Drug|paclitaxel|
16374353|NCT00002568|Procedure|conventional surgery|
16374354|NCT00002516|Biological|dactinomycin|
16374355|NCT00002516|Drug|cyclophosphamide|
16374356|NCT00002516|Drug|doxorubicin hydrochloride|
16374357|NCT00002516|Drug|etoposide|
16374358|NCT00002516|Drug|ifosfamide|
16374359|NCT00002516|Drug|mesna|
16374360|NCT00002516|Drug|vincristine sulfate|
16374361|NCT00002516|Procedure|conventional surgery|
16374362|NCT00002516|Radiation|low-LET cobalt-60 gamma ray therapy|
16374363|NCT00002516|Radiation|low-LET photon therapy|
16374364|NCT00082199|Drug|Aripiprazole|Tablets, Oral, 2-30mg, Once daily, 12 weeks.
16374365|NCT00082199|Drug|Placebo|Tablets, Oral, Once daily, 12 weeks.
16374366|NCT00082186|Drug|bosentan|Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
16374367|NCT00082173|Drug|Moxifloxacin|400mg daily for 8 weeks
16374368|NCT00082160|Behavioral|Meditation|
16374369|NCT00082160|Procedure|Functional Magnetic Resonance Imaging|
16374370|NCT00082134|Drug|ILX651|
16374371|NCT00082121|Drug|TP10|
16374372|NCT00011934|Biological|recombinant interferon alfa|
16374373|NCT00011934|Biological|sargramostim|
16374374|NCT00011934|Procedure|autologous bone marrow transplantation|
16374375|NCT00008242|Drug|dexamethasone|
16374376|NCT00008242|Drug|doxorubicin hydrochloride|
16374377|NCT00008242|Drug|thalidomide|
16374378|NCT00008125|Biological|filgrastim|
16374379|NCT00008125|Drug|carboplatin|
16374380|NCT00008125|Drug|docetaxel|
16374381|NCT00008125|Drug|gemcitabine hydrochloride|
16374382|NCT00008099|Biological|MUC1 antigen/SB AS-2|
16374383|NCT00006682|Drug|docetaxel|Docetaxel 70mg/m2 on day 1 of every 21-day cycle
16374384|NCT00006682|Drug|vinorelbine ditartrate|Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle
16374393|NCT00006342|Genetic|chromosomal translocation analysis|
16374394|NCT00006342|Genetic|gene rearrangement analysis|
16374395|NCT00006342|Genetic|mutation analysis|
16374396|NCT00006112|Drug|chemotherapy|
16374397|NCT00006112|Drug|fluorouracil|
16374398|NCT00006112|Drug|leucovorin calcium|
16374399|NCT00006112|Drug|mitomycin C|
16374400|NCT00006097|Drug|CC-1088|
16374401|NCT00006053|Drug|imatinib mesylate|
16374402|NCT00006039|Biological|pegylated interferon alfa|
16374403|NCT00005988|Drug|cyclophosphamide|
16374404|NCT00005988|Drug|cyclosporine|
16374405|NCT00005988|Drug|leucovorin calcium|
16374406|NCT00005988|Drug|methotrexate|
16374407|NCT00005988|Drug|methylprednisolone|
16374408|NCT00005988|Procedure|in vitro-treated bone marrow transplantation|
16374409|NCT00005988|Radiation|radiation therapy|
16374410|NCT00005974|Drug|alvocidib|Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks
16374411|NCT00005871|Drug|fluorouracil|
16374412|NCT00005871|Drug|rubitecan|
16374418|NCT00005612|Drug|topotecan hydrochloride|
16374419|NCT00005612|Procedure|peripheral blood stem cell transplantation|
16374420|NCT00005594|Drug|ISIS 2503|Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.
16374421|NCT00005081|Drug|O6-benzylguanine|
16374422|NCT00005081|Drug|carmustine|
16374423|NCT00005055|Drug|glufosfamide|
16374424|NCT00005053|Drug|glufosfamide|
16374425|NCT00005021|Biological|filgrastim|
16374426|NCT00005021|Drug|carboplatin|
16374427|NCT00005021|Drug|paclitaxel|
16374428|NCT00005021|Drug|topotecan hydrochloride|
16374429|NCT00004893|Biological|recombinant interleukin-12|
16374430|NCT00004892|Drug|O6-benzylguanine|
16374431|NCT00004892|Drug|polifeprosan 20 with carmustine implant|
16374432|NCT00004892|Procedure|conventional surgery|
16374433|NCT00004884|Drug|cisplatin|
16374434|NCT00004884|Drug|docetaxel|
16374435|NCT00004884|Drug|gemcitabine hydrochloride|
16374436|NCT00004246|Drug|Fludarabine Phosphate|IV on days 1-5 of weeks 6 and 7 of radiotherapy, administered 3-4 hours prior to daily radiotherapy.
16374437|NCT00004246|Radiation|Radiation Therapy (RT)|Days 1-5 for 7 weeks
16374438|NCT00004230|Drug|captopril|
16374439|NCT00004230|Drug|cyclophosphamide|
16374440|NCT00004230|Procedure|autologous bone marrow transplantation|
16374441|NCT00004230|Procedure|peripheral blood stem cell transplantation|
16374442|NCT00004230|Radiation|radiation therapy|
16374443|NCT00004213|Drug|triapine|
16374444|NCT00004101|Biological|apolizumab|
16374445|NCT00004049|Drug|apomine|
16374446|NCT00003972|Biological|filgrastim|
16374447|NCT00003972|Biological|sargramostim|
16374448|NCT00003972|Drug|busulfan|
16374449|NCT00003972|Drug|carboplatin|
16374450|NCT00003972|Drug|cyclophosphamide|
16374451|NCT00003972|Drug|melphalan|
16374452|NCT00003972|Drug|paclitaxel|
16374453|NCT00003972|Drug|tamoxifen citrate|
16374454|NCT00003972|Drug|thiotepa|
16374455|NCT00003972|Procedure|peripheral blood stem cell transplantation|
16374456|NCT00003972|Radiation|radiation therapy|
16374457|NCT00003968|Drug|bryostatin 1|
16374458|NCT00003943|Biological|filgrastim|5 ug/kg
16374459|NCT00003943|Drug|carboplatin|AUC 5
16374460|NCT00003943|Drug|cyclophosphamide|3 gm/m2
16374461|NCT00003943|Drug|paclitaxel|250 mg/m2
16374462|NCT00003943|Drug|topotecan hydrochloride|10 mg/m2
16374463|NCT00003943|Procedure|peripheral blood stem cell transplantation|harvest via apheresis
16374464|NCT00003900|Drug|docetaxel|
16374465|NCT00003900|Drug|irinotecan hydrochloride|
16374466|NCT00003849|Biological|rituximab|
16374467|NCT00003825|Drug|pentosan polysulfate sodium|
16374468|NCT00003825|Procedure|quality-of-life assessment|
16374469|NCT00003768|Drug|fosbretabulin disodium|
16374470|NCT00003726|Biological|lepirudin|lepirudin
16374471|NCT00003713|Drug|intoplicine|
16374472|NCT00003680|Drug|CMF regimen|
16374473|NCT00003680|Drug|cyclophosphamide|
16374474|NCT00003680|Drug|fluorouracil|
16374475|NCT00003680|Drug|methotrexate|
16374476|NCT00003680|Drug|tamoxifen citrate|
16374477|NCT00003680|Drug|thiotepa|
16374478|NCT00003680|Procedure|peripheral blood stem cell transplantation|
16374479|NCT00003680|Radiation|radiation therapy|
16374480|NCT00003646|Drug|allovectin-7|
16374481|NCT00003638|Biological|Detox-B adjuvant|
16374482|NCT00003638|Biological|THERATOPE STn-KLH vaccine|
16374483|NCT00003638|Biological|keyhole limpet hemocyanin|
16374484|NCT00003638|Drug|cyclophosphamide|
16374485|NCT00003622|Drug|paclitaxel|
16374486|NCT00003622|Drug|vinorelbine tartrate|
16374487|NCT00082147|Procedure|Biopsy|Patients will then undergo endorectal coil MR imaging of the prostate gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI During MR imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal needle guide system (APT-MRI).
16374488|NCT00082095|Drug|Pegylated liposomal doxorubicin|Type=exact number, unit=mg/m2, number=40, form=infusion, route=intravenous. Pegylated liposomal doxorubicin will be administered on Day 1 of each cycle. Cycle will be repeated every 28 days, up to 1 year.
16374489|NCT00082095|Drug|Capecitabine|Type=exact number, unit=mg, number=500, form=tablet, route=oral. Capecitabine will be administered at a dosage of 1000 mg/m2 twice daily for 14 consecutive days followed by a 7-day rest period. Cycle is repeated every 21 days, up to one year.
16374490|NCT00082082|Drug|Thymalfasin (thymosin alpha-1)|
16374491|NCT00082082|Procedure|Trans arterial chemoembolization (TACE)|
16374492|NCT00082069|Biological|Shigella flexneri 2a Invaplex 50|
16374493|NCT00081978|Drug|TMC125|
16374494|NCT00003583|Drug|amifostine trihydrate|
16374495|NCT00003583|Drug|cisplatin|
16374496|NCT00003583|Drug|etoposide|
16374497|NCT00003583|Radiation|radiation therapy|
16374498|NCT00003563|Radiation|WBRT|3 GY of WBRT daily for a total of 10 days
16374499|NCT00003563|Drug|MGd|5.0 mg /kg MGd plus WBRT
16374500|NCT00003554|Biological|rituximab|
16374501|NCT00003554|Drug|melphalan|
16374502|NCT00003554|Drug|prednisone|
16374503|NCT00003397|Biological|filgrastim|
16374504|NCT00003397|Biological|rituximab|
16374505|NCT00003397|Biological|sargramostim|
16374506|NCT00003397|Drug|carmustine|
16374507|NCT00003397|Drug|cisplatin|
16374508|NCT00003397|Drug|cyclophosphamide|
16374509|NCT00003397|Drug|dexamethasone|
16374510|NCT00003397|Drug|etoposide|
16374511|NCT00003397|Drug|gemcitabine hydrochloride|
16374512|NCT00003397|Drug|melphalan|
16374513|NCT00003397|Drug|paclitaxel|
16374514|NCT00003397|Procedure|bone marrow ablation with stem cell support|
16374515|NCT00003397|Procedure|peripheral blood stem cell transplantation|
16374516|NCT00003394|Drug|carboplatin|
16374517|NCT00003394|Drug|endocrine-modulating drug therapy|
16374518|NCT00003394|Drug|estramustine phosphate sodium|
16374519|NCT00003394|Drug|goserelin acetate|
16374520|NCT00003394|Drug|leuprolide acetate|
16374521|NCT00003394|Drug|paclitaxel|
16374522|NCT00003276|Drug|irinotecan hydrochloride|
16374523|NCT00003239|Biological|Recombinant Interferon Alfa|Daily by subcutaneous injection.
16374524|NCT00003239|Drug|Cytarabine|Daily by subcutaneous injection.
16374525|NCT00003239|Drug|Omacetaxine Mepesuccinate|Homoharringtonine is administered by continuous infusion on days 1-5.
16374526|NCT00003181|Biological|aldesleukin|
16374527|NCT00003181|Biological|sargramostim|
16374528|NCT00003181|Drug|vinblastine sulfate|
16374529|NCT00003175|Drug|fluorouracil|
16374530|NCT00003165|Drug|doxorubicin-HPMA conjugate|
16374531|NCT00003133|Biological|filgrastim|
16374532|NCT00003133|Drug|cisplatin|
16374533|NCT00003133|Drug|doxorubicin hydrochloride|
16374534|NCT00003133|Drug|gemcitabine hydrochloride|
16374535|NCT00003133|Drug|paclitaxel|
16374536|NCT00003038|Drug|doxorubicin hydrochloride|
16374537|NCT00003038|Drug|suramin|
16374538|NCT00003019|Drug|methotrexate|
16374539|NCT00003019|Drug|vinblastine sulfate|
16374540|NCT00081939|Drug|Velcade|Two cycles of induction on days 1,4,8,11 at 1.0mg/m^2. Two cycles of consolidation on days 1,4,8,11 at 1.0mg/m^2. Maintenance year one 1.0mg/m^2 1,4,8,11 q 28 days.
16374541|NCT00081939|Drug|Thalidomide|Two cycles of VDTPACE 200mg thal days 4-7(cycle 1)and days 1-4 cycle 2 interim Thal 50mg qd between VTDPACE cycles and between cycle 2 and transplant. Thal 100mg between transplants d/c 7 days prior to each transplant. Consolidation therapy cycles 3 and 4 VDTPACE 200mg days 1-4 both cycles. Interim maintenance to maintenance 100mg qd. Maintenance year 1 thal 100mg qd. Maintenance years 2 and 3 Thal 100mg qd.
16374542|NCT00081926|Drug|Gleevec|
16374543|NCT00014365|Drug|MKC-1|
16374544|NCT00006483|Biological|sargramostim|
16374545|NCT00006261|Biological|therapeutic allogeneic lymphocytes|Beginning on day 120 after PBSC transplantation, eligible patients receive unmobilized donor lymphocyte infusion (DLI) over 15-30 minutes. Treatment continues monthly for a total of 3 DLIs in the absence of grade III or IV graft versus host disease or marrow aplasia.
16374546|NCT00006261|Drug|cyclophosphamide|4-10 weeks after completion of salvage chemotherapy, patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of cyclophosphamide IV over 2 hours on days -3 and -2.
16374547|NCT00006261|Drug|docetaxel|Docetaxel IV over 1 hour. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
16374548|NCT00006261|Drug|doxorubicin hydrochloride|Doxorubicin IV over several minutes on day 1. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
16374549|NCT00006261|Drug|fludarabine phosphate|4-10 weeks after completion of salvage chemotherapy, patients achieving complete or partial remission or stable disease receive mini-conditioning comprised of fludarabine IV over 30 minutes on days -8 to -4.
16374550|NCT00006261|Procedure|peripheral blood stem cell transplantation|Filgrastim (G-CSF) and sargramostim (GM-CSF) mobilized allogeneic peripheral blood stem cells (PBSC) IV on day 0.
16374551|NCT00006106|Drug|cisplatin|
16374552|NCT00006106|Drug|fluorouracil|
16374553|NCT00006106|Drug|ONYX-015|
16374554|NCT00003001|Drug|fluorouracil|
16374555|NCT00003001|Drug|gemcitabine hydrochloride|
16374556|NCT00003001|Drug|leucovorin calcium|
16374557|NCT00002977|Biological|filgrastim|
16374558|NCT00002977|Drug|melphalan|
16374559|NCT00002977|Drug|thiotepa|
16374560|NCT00002977|Procedure|peripheral blood stem cell transplantation|
16374561|NCT00002939|Drug|irinotecan hydrochloride|
16374562|NCT00002939|Drug|paclitaxel|
16374563|NCT00002912|Drug|etoposide|
16374564|NCT00002912|Drug|mitoxantrone hydrochloride|
16374565|NCT00002912|Drug|valspodar|
16374566|NCT00002884|Drug|chemotherapy|
16374567|NCT00002884|Drug|cisplatin|
16374568|NCT00002884|Drug|fluorouracil|
16374569|NCT00002884|Radiation|brachytherapy|
16374570|NCT00002884|Radiation|radiation therapy|
16374571|NCT00002773|Biological|allogeneic tumor cell vaccine|
16374572|NCT00002773|Biological|recombinant interferon alfa|
16374573|NCT00002773|Biological|sargramostim|
16374574|NCT00002773|Drug|cyclophosphamide|
16374575|NCT00002719|Biological|filgrastim|
16374576|NCT00002719|Drug|amsacrine|
16374577|NCT00002719|Drug|carmustine|
16374578|NCT00002719|Drug|cytarabine|
16374579|NCT00002719|Drug|etoposide|
16374580|NCT00002719|Drug|idarubicin|
16374581|NCT00002719|Drug|mitoxantrone hydrochloride|
16374582|NCT00002719|Procedure|peripheral blood stem cell transplantation|
16374583|NCT00002680|Biological|filgrastim|
16374584|NCT00002680|Drug|cyclophosphamide|
16374585|NCT00002680|Drug|megestrol acetate|
16374586|NCT00002680|Drug|melphalan|
16374587|NCT00002680|Drug|tamoxifen citrate|
16374588|NCT00002680|Drug|thiotepa|
16374589|NCT00002680|Procedure|conventional surgery|
16374590|NCT00002680|Procedure|peripheral blood stem cell transplantation|
16374591|NCT00002680|Radiation|radiation therapy|
16374592|NCT00002590|Biological|filgrastim|
16374593|NCT00002590|Drug|cyclophosphamide|
16374594|NCT00002590|Drug|cytarabine|
16374595|NCT00002590|Drug|daunorubicin hydrochloride|
16374596|NCT00002590|Drug|doxorubicin hydrochloride|
16374597|NCT00002590|Drug|etoposide|
16374598|NCT00002590|Drug|leucovorin calcium|
16374599|NCT00002590|Drug|methotrexate|
16374600|NCT00002590|Drug|pegaspargase|
16374601|NCT00002590|Drug|prednisone|
16374602|NCT00002590|Drug|thioguanine|
16374603|NCT00002590|Drug|vincristine sulfate|
16374604|NCT00002590|Radiation|radiation therapy|
16374605|NCT00002564|Other|educational intervention|
16374606|NCT00002564|Procedure|therapeutic dietary intervention|
16374607|NCT00002481|Drug|cisplatin|
16374608|NCT00002481|Drug|cyclophosphamide|
16374609|NCT00002481|Drug|cytarabine|
16374610|NCT00002481|Drug|dexamethasone|
16374611|NCT00002481|Drug|etoposide|
16374612|NCT00002481|Procedure|autologous bone marrow transplantation|
16374613|NCT00002481|Radiation|radiation therapy|
16374614|NCT00082043|Drug|Dutasteride|
16374615|NCT00082043|Drug|Placebo oral capsule|
16374616|NCT00082017|Drug|UCN-01 (7-hydroxystaurosporine)|"UCN-01 for relapsed or refractory T-cell lymphomas - Cohort 1, Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.
~UCN-01 for relapsed or refractory T-cell lymphomas - Cohort 2, Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
16374617|NCT00081965|Procedure|acupuncture therapy|
16374618|NCT00081965|Procedure|hot flashes attenuation|
16374619|NCT00081965|Procedure|management of therapy complications|
16374620|NCT00081952|Drug|L-norleucine|
16374621|NCT00081913|Genetic|Cell Therapy - Autologous CD34 Positive Cells|
16374622|NCT00081900|Drug|DENSPM )|Each patient will receive DENSPM at an initial dose of 30mg/m^2, then escalating to 120mg/m^2, single IV infusion on D1,3,5,8,10,12 of every 28 days as one cycle, planned for 8 cycles if no withdrawn occur
16374623|NCT00005969|Drug|Chemotherapy|
16374624|NCT00005969|Drug|Tretinoin Liposome|Liposome by vein (IV) over 30 minutes every other day for 28 days
16374625|NCT00005883|Drug|phenethyl isothiocyanate|
16374626|NCT00005796|Procedure|filgrastim|GCSF is given after chemo administration
16374627|NCT00005796|Biological|gene therapy|stem cells are collected and given back to the patients after chemotherapy adminstration
16374628|NCT00005796|Drug|lomustine|chemotherapy is administered every 21 days
16374629|NCT00005796|Drug|procarbazine hydrochloride|chemotherapy is administered every 21 days.
16374630|NCT00005796|Drug|vincristine sulfate|chemotherapy is administered every 21 days
16374631|NCT00005796|Procedure|in vitro-treated peripheral blood stem cell transplantation|stem cells are reinfused after chemotherapy administration
16374632|NCT00005649|Drug|capecitabine|
16374633|NCT00005649|Drug|paclitaxel|
16374634|NCT00004933|Drug|hydroxyurea|0.5 to 5 grams PO per day
16374635|NCT00004933|Drug|Homoharringtonine|2.5 mg/ sq m/ day CIVI for 14 days
16374636|NCT00004923|Drug|docetaxel|
16374637|NCT00004923|Drug|irinotecan hydrochloride|
16374638|NCT00004903|Biological|filgrastim|
16374639|NCT00004903|Biological|recombinant interferon alfa|
16374640|NCT00004903|Drug|cisplatin|
16374641|NCT00004903|Drug|cyclophosphamide|
16374642|NCT00004903|Drug|cytarabine|
16374643|NCT00004903|Drug|etoposide|
16374644|NCT00004903|Drug|melphalan|
16374645|NCT00004903|Procedure|peripheral blood stem cell transplantation|
16374646|NCT00004878|Biological|therapeutic allogeneic lymphocytes|
16374647|NCT00004878|Drug|cytarabine|
16374648|NCT00004878|Drug|fludarabine phosphate|
16374649|NCT00004878|Drug|idarubicin|
16374650|NCT00004878|Drug|methotrexate|
16374651|NCT00004878|Drug|tacrolimus|
16374652|NCT00004878|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16374653|NCT00004878|Procedure|peripheral blood stem cell transplantation|
16374654|NCT00004872|Biological|recombinant human endostatin|
16374655|NCT00004858|Biological|B43-genistein immunoconjugate|
16374656|NCT00004604|Biological|CEA RNA-pulsed DC cancer vaccine|carcinoembryonic antigen RNA-pulsed dendritic cells
16374657|NCT00004249|Biological|QS21|
16374658|NCT00004249|Biological|keyhole limpet hemocyanin|
16374659|NCT00004249|Drug|polysialic acid|
16374660|NCT00004174|Biological|filgrastim|
16374661|NCT00004174|Drug|cyclophosphamide|
16374662|NCT00004174|Drug|paclitaxel|
16374663|NCT00004174|Drug|thiotepa|
16374664|NCT00004174|Procedure|peripheral blood stem cell transplantation|
16374665|NCT00004174|Radiation|radiation therapy|
16374666|NCT00003960|Drug|busulfan|
16374667|NCT00003960|Drug|cyclophosphamide|
16374668|NCT00003960|Drug|methylprednisolone|
16374669|NCT00003960|Procedure|allogeneic bone marrow transplantation|
16374670|NCT00003960|Procedure|in vitro-treated bone marrow transplantation|
16374671|NCT00003953|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each 2 week course.
16374672|NCT00003953|Drug|CMF regimen|Stratum I and II: receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4 courses
16374673|NCT00003953|Drug|docetaxel|Docetaxel IV over 1 hour on days 43, 57, and 71.
16374674|NCT00003953|Drug|doxorubicin hydrochloride|Doxorubicin IV on days 1, 15, and 29.
16374675|NCT00003953|Drug|tamoxifen citrate|Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.
16374676|NCT00003953|Procedure|autologous bone marrow transplantation|Stratum III:may receive high dose chemotherapy with stem cell support
16374677|NCT00003953|Procedure|surgical procedure|Fourteen to 21 days following preoperative chemotherapy, patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph node dissection.
16374678|NCT00003953|Radiation|radiation therapy|Radiotherapy is administered 5 days a week for 5.5 weeks.
16374679|NCT00081887|Drug|Clofarabine|Starting dose is 10 mg/m^2 as a 1-hour infusion into a vein once every 2 weeks for 4 weeks (1 cycle).
16374680|NCT00081874|Drug|RAD001|"Phase I: Starting dose 5 mg by mouth daily for 28 days.
~Phase II: Maximum Tolerated Dose (MTD) from Phase I."
16374681|NCT00081861|Drug|Avastin|10 mg/kg given intravenously every 2 weeks for 4 doses.
16374977|NCT00005989|Drug|tipifarnib|
16374682|NCT00081861|Drug|Rituximab|375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
16374683|NCT00003950|Drug|cyclosporine|
16374684|NCT00003950|Drug|CPT-11|
16374685|NCT00003914|Drug|dolastatin 10|
16374686|NCT00003887|Biological|peripheral blood lymphocyte therapy|
16374687|NCT00003835|Drug|leucovorin calcium|Given IV
16374688|NCT00003835|Drug|fluorouracil|Given IV
16374689|NCT00003835|Drug|irinotecan hydrochloride|Given IV
16374690|NCT00003835|Other|laboratory biomarker analysis|Correlative studies
16374691|NCT00003819|Biological|QS21|
16374692|NCT00003819|Biological|TF(c)-KLH conjugate vaccine|
16374693|NCT00003819|Biological|Thomsen-Friedenreich antigen|
16374694|NCT00003819|Biological|keyhole limpet hemocyanin|
16374695|NCT00003783|Biological|filgrastim|
16374696|NCT00003783|Drug|asparaginase|
16374697|NCT00003783|Drug|cyclophosphamide|
16374698|NCT00003783|Drug|cytarabine|
16374699|NCT00003783|Drug|daunorubicin hydrochloride|
16374700|NCT00003783|Drug|dexamethasone|
16374701|NCT00003783|Drug|etoposide|
16374702|NCT00003783|Drug|idarubicin|
16374703|NCT00003783|Drug|leucovorin calcium|
16374704|NCT00003783|Drug|mercaptopurine|
16374705|NCT00003783|Drug|methotrexate|
16374706|NCT00003783|Drug|prednisone|
16374707|NCT00003783|Drug|vincristine sulfate|
16374708|NCT00003783|Radiation|radiation therapy|
16374709|NCT00003765|Drug|O6-benzylguanine|
16374710|NCT00003765|Drug|carmustine|
16374711|NCT00003619|Biological|filgrastim|
16374712|NCT00003619|Dietary Supplement|vitamin E|
16374713|NCT00003619|Drug|busulfan|
16374714|NCT00003619|Drug|cytarabine|
16374715|NCT00003619|Drug|etoposide|
16374716|NCT00003619|Drug|fludarabine phosphate|
16374717|NCT00003619|Drug|isotretinoin|
16374718|NCT00003619|Drug|topotecan hydrochloride|
16374719|NCT00003619|Procedure|bone marrow ablation with stem cell support|
16374720|NCT00003619|Procedure|peripheral blood stem cell transplantation|
16374721|NCT00003544|Drug|irinotecan hydrochloride|
16374722|NCT00003544|Procedure|surgical procedure|
16374723|NCT00003434|Biological|carcinoembryonic antigen peptide 1|
16374724|NCT00003434|Biological|hepatitis B antigen peptide|
16374725|NCT00003427|Drug|irinotecan hydrochloride|
16374726|NCT00003427|Drug|oxaliplatin|
16374727|NCT00003407|Drug|amifostine trihydrate|
16374728|NCT00003407|Drug|cytarabine|
16374729|NCT00003407|Drug|mitoxantrone hydrochloride|
16374730|NCT00003398|Biological|anti-thymocyte globulin|
16374731|NCT00003398|Biological|filgrastim|
16374732|NCT00003398|Drug|cyclophosphamide|
16374733|NCT00003398|Drug|thiotepa|
16374734|NCT00003398|Procedure|allogeneic bone marrow transplantation|
16374735|NCT00003398|Procedure|bone marrow ablation with stem cell support|
16374736|NCT00003398|Radiation|radiation therapy|
16374737|NCT00003270|Biological|anti-thymocyte globulin|IV
16374738|NCT00003270|Biological|filgrastim|IV
16374739|NCT00003270|Drug|busulfan|IV
16374740|NCT00003270|Drug|cyclophosphamide|IV
16374741|NCT00003270|Drug|cyclosporine|IV
16374742|NCT00003270|Drug|methylprednisolone|IV
16374743|NCT00003270|Procedure|bone marrow ablation with stem cell support|IV
16374744|NCT00003270|Procedure|umbilical cord blood transplantation|IV
16374745|NCT00003270|Radiation|radiation therapy|High energy X-rays
16374746|NCT00003144|Drug|amifostine trihydrate|
16374747|NCT00003144|Drug|cisplatin|
16374748|NCT00003144|Drug|gemcitabine hydrochloride|
16374749|NCT00003094|Other|preventative dietary intervention|
16374750|NCT00003081|Biological|filgrastim|
16374751|NCT00003081|Drug|busulfan|
16374752|NCT00003081|Drug|melphalan|
16374753|NCT00003081|Drug|thiotepa|
16374754|NCT00003081|Procedure|peripheral blood stem cell transplantation|
16374755|NCT00003081|Radiation|radiation therapy|
16374756|NCT00002964|Drug|porfimer sodium|
16374757|NCT00002964|Other|fluorophotometry|
16374758|NCT00002866|Biological|filgrastim|
16374759|NCT00002866|Drug|docetaxel|
16374760|NCT00002866|Drug|epirubicin hydrochloride|
16374761|NCT00006475|Drug|imatinib mesylate|
16374762|NCT00006463|Drug|ECTEINASCIDIN 743|
16374763|NCT00006357|Drug|imatinib mesylate|
16374764|NCT00006216|Biological|PA-1-STK ovarian carcinoma vaccine|
16374765|NCT00006216|Drug|ganciclovir|
16374766|NCT00006049|Drug|carboplatin|
16374767|NCT00006049|Drug|gefitinib|
16374768|NCT00006049|Drug|paclitaxel|
16374769|NCT00006048|Drug|cisplatin|
16374770|NCT00006048|Drug|gefitinib|
16374771|NCT00006048|Drug|gemcitabine hydrochloride|
16374772|NCT00005870|Drug|fluorouracil|
16374773|NCT00005870|Drug|gemcitabine hydrochloride|
16374774|NCT00005870|Drug|mitomycin C|
16374775|NCT00005870|Drug|rubitecan|
16374776|NCT00005849|Drug|bryostatin 1|
16374777|NCT00005849|Drug|paclitaxel|
16374778|NCT00005842|Biological|trastuzumab|
16374779|NCT00005842|Drug|tipifarnib|
16374780|NCT00005832|Drug|R115777|300mg/dose BID, PO, Days 1-21, q 28days
16374781|NCT00002794|Drug|carboplatin|
16374782|NCT00002794|Drug|vincristine sulfate|
16374783|NCT00002553|Drug|cyclophosphamide|
16374784|NCT00002553|Procedure|allogeneic bone marrow transplantation|
16374785|NCT00002553|Radiation|low-LET cobalt-60 gamma ray therapy|
16374786|NCT00002485|Procedure|psychosocial assessment and care|
16374787|NCT00002466|Drug|cyclophosphamide|
16374788|NCT00002466|Drug|doxorubicin hydrochloride|
16374789|NCT00002466|Drug|etoposide|
16374790|NCT00002466|Drug|ifosfamide|
16374978|NCT00005958|Biological|filgrastim|
16374791|NCT00002466|Drug|vincristine sulfate|
16374792|NCT00002466|Procedure|conventional surgery|
16374793|NCT00002466|Radiation|radiation therapy|
16374794|NCT00002456|Drug|cyclosporine|
16374795|NCT00002456|Drug|methotrexate|
16374796|NCT00002456|Procedure|allogeneic bone marrow transplantation|
16374797|NCT00081822|Drug|clofarabine|Clofarabine should be administered by daily intravenous infusion over 2 hours.Following demonstration of DLT at Dose Level -I (22.5 mg/m2/day days 2-6) and demonstration that Dose Level -II (15mg/m2day days 2-6) is the 'optimal phase II dose', an additional Dose Level -1½ (20mg/m2/day, days 2-6) will be added to explore an increased dose of clofarabine intermediate between Dose Levels -I and -II.
16374798|NCT00081822|Drug|Ara-C|Ara-C: Administer Ara-C by continuous infusion of 100mg/m2/day on days 1 to 7 for cycle 1, and on days 1 to 5 for cycles 2 & 3.
16374799|NCT00081809|Drug|autologous human tumor-derived HSPPC-96|
16374800|NCT00005092|Drug|Cyclophosphamide|IV over 2 hours on days 2 and 3
16374801|NCT00005092|Drug|Psoralen|Psoralen treated T-cell allogeneic transplant on day 9
16374802|NCT00005092|Drug|Thiotepa|IV over 2 hours on day 1
16374803|NCT00005092|Procedure|Allogeneic bone marrow transplantation|Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9
16374804|NCT00005092|Procedure|In vitro-treated peripheral blood stem cell transplantation (PBSCT)|Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9
16374805|NCT00005092|Radiation|Radiation Therapy (RT)|Whole body radiotherapy on days 5-8.
16374806|NCT00005082|Procedure|biopsy|
16374807|NCT00005082|Procedure|magnetic resonance imaging|
16374808|NCT00005023|Biological|HER-2/neu peptide vaccine|
16374809|NCT00005023|Biological|sargramostim|
16374810|NCT00004870|Biological|oblimersen sodium|
16374811|NCT00004870|Drug|irinotecan hydrochloride|
16374812|NCT00004254|Drug|raltitrexed|
16374813|NCT00004013|Biological|trastuzumab|
16374814|NCT00004013|Drug|paclitaxel|
16374815|NCT00003899|Biological|filgrastim|
16374816|NCT00003899|Drug|cyclophosphamide|
16374817|NCT00003899|Drug|melphalan|
16374818|NCT00003899|Drug|paclitaxel|
16374819|NCT00003899|Drug|thiotepa|
16374820|NCT00003899|Procedure|autologous bone marrow transplantation|
16374821|NCT00003899|Procedure|peripheral blood stem cell transplantation|
16374822|NCT00003880|Biological|recombinant adenovirus-p53 SCH-58500|
16374823|NCT00003880|Drug|carboplatin|
16374824|NCT00003880|Drug|paclitaxel|
16374825|NCT00003790|Genetic|polymerase chain reaction|
16374826|NCT00003790|Other|flow cytometry|
16374827|NCT00003735|Drug|topotecan hydrochloride|given by mouth
16374828|NCT00003715|Biological|BCG vaccine|
16374829|NCT00003715|Biological|autologous tumor cell vaccine|
16374830|NCT00003715|Biological|recombinant interferon alfa|
16374831|NCT00003715|Drug|chemotherapy|
16374832|NCT00003715|Drug|cyclophosphamide|
16374833|NCT00003701|Drug|carboplatin|
16374834|NCT00003701|Drug|cisplatin|
16374835|NCT00003701|Drug|doxorubicin hydrochloride|
16374836|NCT00003701|Drug|methotrexate|
16374837|NCT00003701|Drug|paclitaxel|
16374838|NCT00003701|Drug|vinblastine sulfate|
16374839|NCT00003621|Drug|carmustine|
16374840|NCT00003621|Drug|cisplatin|
16374841|NCT00003621|Drug|etoposide|
16374842|NCT00003621|Radiation|radiation therapy|
16374843|NCT00003445|Drug|docetaxel|
16374844|NCT00003386|Biological|BCG vaccine|
16374845|NCT00003386|Biological|autologous tumor cell vaccine|
16374846|NCT00003386|Drug|carboplatin|
16374847|NCT00003386|Drug|cisplatin|
16374848|NCT00003386|Drug|cyclophosphamide|
16374849|NCT00003386|Drug|paclitaxel|
16374850|NCT00003386|Other|dinitrophenyl|
16374851|NCT00003386|Procedure|surgical procedure|
16374852|NCT00003148|Biological|aldesleukin|
16374853|NCT00003146|Drug|busulfan|
16374854|NCT00003146|Drug|melphalan|
16374855|NCT00003146|Drug|thiotepa|
16374856|NCT00003146|Procedure|bone marrow transplantation|
16374857|NCT00003146|Procedure|peripheral blood stem cell transplantation|
16374858|NCT00003076|Drug|eflornithine|
16374859|NCT00003041|Drug|pyrazoloacridine|
16374860|NCT00081848|Drug|rV-CEA(6D)/TRICOM-rF-CEA(6D)/TRICOM|
16374861|NCT00081848|Drug|rF-CEA(6D)/TRICOM|
16374862|NCT00081848|Drug|Recombinant Fowlpox-GM-CSF|
16374863|NCT00081848|Drug|Celecoxib|
16374864|NCT00081835|Drug|NP-016 Vaccine Immune Globulin (IV-VIG)|
16374865|NCT00081796|Drug|larotaxel (RPR109881, XRP9881)|
16374866|NCT00081796|Drug|capecitabine|
16374867|NCT00081783|Drug|Xcellerated T Cells|
16374868|NCT00081770|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|1.5 ug/kg/week subcutaneously (SC) for 48 weeks
16374869|NCT00081770|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|1.0 ug/kg/week SC for 48 weeks
16374870|NCT00081770|Drug|REBETOL (ribavirin; SCH 18908)|weight based dose 800-1400 mg/day orally (PO) for 48 weeks
16374871|NCT00081770|Biological|PEGASYS (peginterferon alfa-2a)|180 ug/week SC administered for 48 weeks
16374872|NCT00081770|Drug|COPEGUS (ribavirin)|1000-1200 mg/day PO for 48 weeks
16374873|NCT00081757|Drug|Thalidomide|
16374874|NCT00021346|Drug|carboplatin|
16374875|NCT00021346|Drug|gemcitabine hydrochloride|
16374876|NCT00019357|Biological|aldesleukin|
16374877|NCT00019357|Biological|therapeutic autologous lymphocytes|
16374878|NCT00019357|Biological|therapeutic tumor infiltrating lymphocytes|
16374879|NCT00003018|Drug|dipyridamole|75mg/dose, PO, Days 1-28 of 5 week cycle
16374880|NCT00003018|Drug|fluorouracil|200 mg/m^2/day, continuous IV, Days 1-28 of 5 week cycle
16374881|NCT00003018|Drug|leucovorin calcium|30 mg/m^2/day, IV, Days 1,8,15,22 of 5 week cycle
16374979|NCT00005958|Drug|docetaxel|
16374882|NCT00003018|Drug|mitomycin C|10 mg/m^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
16374883|NCT00003017|Biological|recombinant interleukin-12|
16374884|NCT00002952|Biological|MART-1 antigen|Melan-A peptide loaded PBMCs (sc, q3wk x 3)
16374885|NCT00002952|Biological|recombinant MAGE-3.1 antigen|
16374886|NCT00002952|Biological|recombinant interleukin-12|rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)
16374887|NCT00002889|Drug|flutamide|
16374888|NCT00002889|Drug|goserelin|
16374889|NCT00002889|Drug|leuprolide acetate|
16374890|NCT00002889|Radiation|low-LET photon therapy|
16374891|NCT00002818|Drug|cytarabine|
16374892|NCT00002818|Drug|deoxycytidine|
16374893|NCT00002800|Biological|filgrastim|
16374894|NCT00002800|Biological|lintuzumab|
16374895|NCT00002800|Drug|cytarabine|
16374896|NCT00002800|Drug|etoposide|
16374897|NCT00002800|Drug|idarubicin|
16374898|NCT00002772|Biological|filgrastim|
16374899|NCT00002772|Drug|carboplatin|
16374900|NCT00002772|Drug|carmustine|
16374901|NCT00002772|Drug|cisplatin|
16374902|NCT00002772|Drug|cyclophosphamide|
16374903|NCT00002772|Drug|doxorubicin hydrochloride|
16374904|NCT00002772|Drug|paclitaxel|
16374905|NCT00002772|Drug|tamoxifen citrate|
16374906|NCT00002772|Drug|thiotepa|
16374907|NCT00002772|Procedure|autologous bone marrow transplantation|
16374908|NCT00002772|Procedure|peripheral blood stem cell transplantation|
16374909|NCT00002772|Radiation|radiation therapy|
16374910|NCT00002768|Biological|filgrastim|10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed
16374911|NCT00002768|Drug|busulfan|1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.
16374912|NCT00002768|Drug|cytarabine|2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4
16374913|NCT00002768|Drug|etoposide|40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant
16374914|NCT00002768|Drug|methotrexate|For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation
16374915|NCT00002768|Procedure|peripheral blood stem cell transplantation|Infusion on Day 0
16374916|NCT00002764|Biological|filgrastim|
16374917|NCT00002764|Drug|doxorubicin hydrochloride|
16374918|NCT00002764|Drug|ifosfamide|
16374919|NCT00002764|Procedure|conventional surgery|
16374920|NCT00002745|Drug|aminocamptothecin|850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response
16374921|NCT00002722|Drug|cisplatin|
16374922|NCT00002722|Drug|fluorouracil|
16374923|NCT00002722|Drug|leucovorin calcium|
16374924|NCT00002595|Drug|toremifene|
16374925|NCT00002595|Procedure|conventional surgery|
16374926|NCT00002583|Drug|cisplatin|50 mg/m2 IV
16374927|NCT00002583|Drug|vinorelbine ditartrate|25 mg/m2 IV
16374928|NCT00002534|Biological|anti-thymocyte globulin|
16374929|NCT00002534|Drug|cyclophosphamide|
16374930|NCT00002534|Drug|cytarabine|
16374931|NCT00002534|Drug|methylprednisolone|
16374932|NCT00002534|Drug|thiotepa|
16374933|NCT00002534|Procedure|allogeneic bone marrow transplantation|
16374934|NCT00002534|Procedure|in vitro-treated bone marrow transplantation|
16374935|NCT00002534|Radiation|low-LET electron therapy|
16374936|NCT00002534|Radiation|low-LET photon therapy|
16374937|NCT00002519|Drug|chemotherapy|
16374938|NCT00002519|Drug|paclitaxel|
16374939|NCT00002519|Radiation|radiation therapy|
16374940|NCT00002501|Biological|filgrastim|
16374941|NCT00002501|Drug|cyclophosphamide|
16374942|NCT00002492|Drug|cisplatin|
16374943|NCT00002492|Drug|doxorubicin hydrochloride|
16374944|NCT00002492|Drug|isolated limb perfusion|
16374945|NCT00002492|Procedure|conventional surgery|
16374946|NCT00002492|Radiation|brachytherapy|
16374947|NCT00002492|Radiation|radiation therapy|
16374948|NCT00002463|Drug|MOPP Regimen|Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)
16374949|NCT00002463|Drug|Leucovorin Calcium|
16374950|NCT00002463|Drug|Mechlorethamine Hydrochloride|
16374951|NCT00002463|Drug|Methotrexate|
16374952|NCT00002463|Drug|Prednisone|
16374953|NCT00002463|Drug|Procarbazine Hydrochloride|
16374954|NCT00002463|Drug|Vincristine Sulfate|
16374955|NCT00002463|Procedure|Conventional Surgery|
16374956|NCT00081744|Drug|Tigecycline|
16374957|NCT00081731|Drug|Atacand/HCT, Caduet|Atacand/HCT and caduet or optimal medical therapy for hypertension
16374958|NCT00081731|Procedure|GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)|Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
16374959|NCT00081653|Drug|ibandronate [Bonviva/Boniva]|150mg po monthly for 3 years
16374960|NCT00081653|Drug|ibandronate [Bonviva/Boniva]|100mg po monthly for 3 years
16374961|NCT00019344|Drug|alvocidib|
16374962|NCT00019240|Drug|cidofovir|
16374963|NCT00016900|Drug|liposomal paclitaxel|
16374964|NCT00010010|Drug|exemestane|
16374965|NCT00010010|Drug|goserelin acetate|
16374966|NCT00009828|Drug|leucovorin calcium|
16374967|NCT00009828|Drug|paclitaxel|
16374968|NCT00009828|Drug|tegafur-uracil|
16374969|NCT00081614|Drug|Avastin (bevacizumab)|
16374970|NCT00081614|Drug|Tarceva (erlotinib HCl)|
16374971|NCT00081549|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
16374972|NCT00081536|Drug|Aroplatin (Liposomal NDDP) in combination with capecitabine|
16374973|NCT00012129|Drug|liposomal annamycin|
16374974|NCT00009815|Drug|etoposide|
16374975|NCT00009815|Drug|leucovorin calcium|
16374976|NCT00009815|Drug|tegafur-uracil|
16374980|NCT00005958|Drug|gemcitabine hydrochloride|
16374981|NCT00005950|Drug|nelarabine|Given IV
16374982|NCT00005938|Drug|exatecan mesylate|
16374983|NCT00005828|Dietary Supplement|green tea extract|
16374984|NCT00005827|Dietary Supplement|genistein|
16374985|NCT00081640|Drug|PRO 2000/5 Gel (P)|
16374986|NCT00081601|Drug|CEP-701|
16374987|NCT00081588|Drug|TMC114|600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
16374988|NCT00081575|Drug|Tigecycline|
16374989|NCT00081575|Drug|Levofloxacin|
16374990|NCT00081380|Drug|Seroquel®, quetiapine fumarate (atypical antipsychotic)|
16374991|NCT00081380|Drug|lithium (mood stabilizer)|
16374992|NCT00081380|Drug|divalproex (mood stabilizer)|
16374993|NCT00005810|Biological|filgrastim|
16374994|NCT00005810|Drug|carboplatin|
16374995|NCT00005810|Drug|docetaxel|
16374996|NCT00005810|Drug|estramustine phosphate sodium|
16374997|NCT00005809|Procedure|computed tomography|
16374998|NCT00005809|Procedure|diagnostic colonoscopy|
16374999|NCT00005643|Drug|pegylated liposomal doxorubicin hydrochloride|
16375000|NCT00005625|Drug|trabectedin|
16375001|NCT00005608|Drug|leucovorin calcium|
16375002|NCT00005608|Drug|tegafur-uracil|
16375003|NCT00005080|Drug|nelarabine|Given IV
16375004|NCT00005071|Procedure|biopsy|
16375005|NCT00005071|Procedure|bronchoscopy|
16375006|NCT00005071|Procedure|computed tomography|
16375007|NCT00005071|Procedure|quality-of-life assessment|
16375008|NCT00004252|Drug|fluorouracil|
16375009|NCT00004252|Drug|leucovorin calcium|
16375010|NCT00004252|Drug|semaxanib|
16375011|NCT00004229|Biological|recombinant human endostatin|
16375012|NCT00004178|Biological|therapeutic autologous lymphocytes|
16375013|NCT00081510|Drug|Lonafarnib|
16375014|NCT00081510|Drug|Placebo|
16375015|NCT00081510|Drug|anastrozole|
16375016|NCT00081497|Biological|agalsidase beta|1.0 mg/kg every 2 weeks
16375017|NCT00081484|Drug|epoetin alfa or beta|iv or sc, as prescribed
16375018|NCT00081484|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
16375019|NCT00081471|Drug|darbepoetin alfa|0.45 micrograms/kg sc (starting dose) weekly
16375020|NCT00081471|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.6 micrograms/kg sc (starting dose) once every 2 weeks
16375021|NCT00004177|Biological|filgrastim|as prescribed by physician
16375022|NCT00004177|Procedure|peripheral blood stem cell transplantation|1-2 weeks from treatment
16375023|NCT00004177|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
16375024|NCT00004177|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
16375025|NCT00004108|Drug|exatecan mesylate|
16375026|NCT00004107|Biological|filgrastim|as prescribed by physician
16375027|NCT00004107|Procedure|autologous bone marrow transplantation|1-2 weeks before treatment
16375028|NCT00004107|Procedure|peripheral blood stem cell transplantation|1-2 weeks before treatment
16375029|NCT00004107|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
16375030|NCT00004107|Radiation|yttrium Y 90 epratuzumab|intravenous infusion over 30 min; single dose
16375031|NCT00004100|Drug|cisplatin|
16375032|NCT00004100|Drug|gemcitabine hydrochloride|
16375033|NCT00004100|Drug|vinorelbine tartrate|
16375034|NCT00004087|Biological|filgrastim|as prescribed by physician
16375035|NCT00004087|Procedure|autologous bone marrow transplantation|1-2 weeks before treatment
16375036|NCT00004087|Procedure|peripheral blood stem cell transplantation|1-2 weeks before treatment
16375037|NCT00004087|Radiation|indium In 111 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
16375038|NCT00004087|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min; single dose
16375039|NCT00004086|Biological|filgrastim|
16375040|NCT00004086|Drug|cisplatin|
16375041|NCT00004086|Drug|cytarabine|
16375042|NCT00004086|Drug|etoposide|
16375043|NCT00004086|Drug|ifosfamide|
16375044|NCT00004086|Procedure|autologous bone marrow transplantation|
16375045|NCT00004086|Procedure|peripheral blood stem cell transplantation|
16375046|NCT00004086|Radiation|indium In 111 LL2 IgG|
16375047|NCT00004086|Radiation|yttrium Y 90 epratuzumab|
16375048|NCT00004085|Biological|filgrastim|as prescribed by physician
16375049|NCT00004085|Procedure|autologous bone marrow transplantation|1-2 weeks prior to treatment
16375050|NCT00004085|Procedure|peripheral blood stem cell transplantation|1-2 weeks prior to treatment
16375051|NCT00004085|Radiation|yttrium Y 90 monoclonal antibody MN-14|intravenous infusion over 30 min, single dose
16375052|NCT00004084|Radiation|indium In 111 LL2 IgG|single dose, intravenous infusion over 30 minutes
16375053|NCT00004084|Radiation|yttrium Y 90 epratuzumab|single dose, intravenous infusion over 30 minutes
16375054|NCT00004048|Biological|filgrastim|
16375055|NCT00004048|Drug|doxorubicin hydrochloride|
16375056|NCT00004048|Procedure|autologous bone marrow transplantation|
16375057|NCT00004048|Procedure|peripheral blood stem cell transplantation|
16375058|NCT00004048|Radiation|indium In 111 monoclonal antibody MN-14|
16375059|NCT00004048|Radiation|yttrium Y 90 monoclonal antibody MN-14|
16375060|NCT00004046|Drug|exatecan mesylate|
16375061|NCT00004045|Drug|exatecan mesylate|
16375062|NCT00004033|Drug|liposomal NDDP|
16375063|NCT00004033|Procedure|therapeutic thoracoscopy|
16375064|NCT00004016|Biological|recombinant interferon gamma|
16375065|NCT00004010|Biological|bleomycin sulfate|
16375066|NCT00004010|Biological|filgrastim|
16375067|NCT00004010|Drug|ABVD regimen|
16375068|NCT00004010|Drug|cyclophosphamide|
16375069|NCT00004010|Drug|dacarbazine|
16375070|NCT00004010|Drug|doxorubicin hydrochloride|
16375071|NCT00004010|Drug|etoposide|
16375072|NCT00004010|Drug|prednisone|
16375073|NCT00004010|Drug|procarbazine hydrochloride|
16375074|NCT00004010|Drug|vinblastine sulfate|
16375075|NCT00004010|Drug|vincristine sulfate|
16375076|NCT00004010|Radiation|radiation therapy|
16375077|NCT00003954|Drug|melphalan|Given IV
16375078|NCT00003954|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous bone marrow or PBSCT
16375079|NCT00003954|Procedure|autologous bone marrow transplantation|Undergo autologous bone marrow or PBSCT
16375080|NCT00003954|Procedure|peripheral blood stem cell transplantation|Undergo autologous bone marrow or PBSCT
16375081|NCT00003954|Radiation|total-body irradiation|Undergo TBI
16375082|NCT00003954|Procedure|peripheral blood stem cell transplantation|Undergo donor PBSCT
16375083|NCT00003954|Drug|cyclosporine|Given IV and PO
16375084|NCT00003954|Drug|mycophenolate mofetil|Given PO
16375085|NCT00003954|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
16375086|NCT00081458|Drug|Placebo|placebo injectable subcutaneously daily into thigh or abdomen
16375087|NCT00081458|Drug|Teduglutide 0.05 mg/kg/d|Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
16375088|NCT00081458|Drug|Teduglutide 0.1 mg/kg/d|Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
16375089|NCT00003917|Drug|topotecan hydrochloride|
16375090|NCT00003870|Drug|cyclophosphamide|
16375091|NCT00003870|Drug|methotrexate|
16375092|NCT00003870|Procedure|allogeneic bone marrow transplantation|
16375093|NCT00003870|Radiation|iodine I 131 monoclonal antibody BC8|
16375094|NCT00003870|Radiation|radiation therapy|
16375095|NCT00003834|Drug|fluorouracil|
16375096|NCT00003834|Drug|leucovorin calcium|
16375097|NCT00003834|Drug|oxaliplatin|
16375098|NCT00003824|Drug|cephalexin|500 mg oral bid for 3 days starting the night before resection
16375099|NCT00003824|Procedure|surgical procedure|
16375100|NCT00003824|Drug|Ciprofloxacin|500 mg oral bid for 3 days starting the night before resection
16375101|NCT00003809|Biological|cetuximab|
16375102|NCT00003809|Drug|cisplatin|
16375103|NCT00003719|Drug|irinotecan hydrochloride|
16375104|NCT00003718|Drug|temozolomide|
16375105|NCT00003717|Drug|estramustine phosphate sodium|
16375106|NCT00003717|Drug|paclitaxel|
16375107|NCT00003674|Drug|dalteparin|
16375108|NCT00003674|Drug|standard therapy|
16375109|NCT00003493|Drug|dexamethasone|
16375110|NCT00003493|Drug|pegylated liposomal doxorubicin hydrochloride|
16375111|NCT00003493|Drug|vincristine sulfate|
16375112|NCT00003307|Drug|amifostine trihydrate|
16375113|NCT00003307|Radiation|radiation therapy|
16375114|NCT00003283|Drug|octreotide acetate|
16375115|NCT00003283|Drug|prednisone|
16375116|NCT00003235|Drug|carboplatin|
16375117|NCT00003235|Drug|paclitaxel|
16375118|NCT00003235|Radiation|radiation therapy|
16375119|NCT00003209|Biological|bleomycin sulfate|
16375120|NCT00003209|Drug|cisplatin|
16375121|NCT00003209|Drug|fluorouracil|
16375122|NCT00003209|Drug|ifosfamide|
16375123|NCT00003209|Drug|methotrexate|
16375124|NCT00003209|Drug|mitomycin C|
16375125|NCT00003209|Drug|vinblastine sulfate|
16375126|NCT00003209|Drug|vindesine|
16375127|NCT00003209|Radiation|radiation therapy|
16375128|NCT00003125|Biological|ALVAC-CEA vaccine|
16375129|NCT00003125|Biological|aldesleukin|
16375130|NCT00003125|Biological|sargramostim|
16375131|NCT00003125|Biological|vaccinia-CEA vaccine|
16375132|NCT00003080|Drug|endocrine-modulating drug therapy|
16375133|NCT00003080|Drug|melphalan|
16375134|NCT00003080|Drug|mitoxantrone hydrochloride|
16375135|NCT00003080|Drug|tamoxifen citrate|
16375136|NCT00003080|Drug|thiotepa|
16375137|NCT00003080|Procedure|peripheral blood stem cell transplantation|
16375138|NCT00003061|Drug|cytarabine|
16375139|NCT00003061|Drug|methotrexate|
16375140|NCT00003061|Radiation|radiation therapy|
16375141|NCT00003032|Biological|filgrastim|
16375142|NCT00003032|Drug|cisplatin|
16375143|NCT00003032|Drug|cyclophosphamide|
16375144|NCT00003032|Drug|mitoxantrone hydrochloride|
16375145|NCT00003032|Drug|tamoxifen citrate|
16375146|NCT00003010|Drug|marimastat|
16375147|NCT00021398|Drug|fluorouracil|
16375148|NCT00021398|Drug|leucovorin calcium|
16375149|NCT00021398|Procedure|conventional surgery|
16375150|NCT00021398|Radiation|radiation therapy|
16375151|NCT00021281|Drug|FOLFIRI regimen|
16375152|NCT00021281|Drug|fluorouracil|
16375153|NCT00021281|Drug|irinotecan hydrochloride|
16375154|NCT00021281|Drug|leucovorin calcium|
16375155|NCT00021281|Drug|semaxanib|
16375156|NCT00021151|Biological|alemtuzumab|
16375157|NCT00021008|Drug|picoplatin|
16375158|NCT00020774|Drug|gemcitabine hydrochloride|
16375159|NCT00020774|Drug|lonafarnib|
16375160|NCT00020774|Procedure|conventional surgery|
16375161|NCT00019552|Drug|irofulven|
16375162|NCT00019474|Biological|filgrastim|
16375163|NCT00019474|Biological|recombinant interferon alfa|
16375164|NCT00019474|Drug|fluorouracil|
16375165|NCT00019474|Drug|hydroxyurea|
16375166|NCT00019318|Drug|romidepsin|
16375167|NCT00019123|Drug|thalidomide|
16375168|NCT00014391|Biological|palivizumab|
16375169|NCT00014391|Drug|ribavirin|
16375170|NCT00012311|Biological|filgrastim|
16375171|NCT00012311|Drug|CMF regimen|
16375172|NCT00012311|Drug|carboplatin|
16375173|NCT00012311|Drug|cyclophosphamide|
16375174|NCT00012311|Drug|docetaxel|
16375175|NCT00012311|Drug|doxorubicin hydrochloride|
16375176|NCT00012311|Drug|etoposide|
16375177|NCT00012311|Drug|fluorouracil|
16375178|NCT00012311|Drug|ifosfamide|
16375179|NCT00012311|Drug|methotrexate|
16375180|NCT00012311|Drug|thiotepa|
16375181|NCT00012311|Procedure|peripheral blood stem cell transplantation|
16375182|NCT00010283|Drug|beclomethasone dipropionate|
16375183|NCT00007943|Drug|gemcitabine hydrochloride|
16375184|NCT00006045|Biological|lintuzumab|
16375185|NCT00006045|Drug|cytarabine|
16375186|NCT00006045|Drug|etoposide|
16375187|NCT00006045|Drug|mitoxantrone hydrochloride|
16375188|NCT00005875|Drug|rubitecan|
16375189|NCT00005874|Drug|rubitecan|
16375190|NCT00005873|Drug|rubitecan|
16375191|NCT00002708|Procedure|surgical procedure|
16375192|NCT00002708|Radiation|radiation therapy|
16375193|NCT00002708|Radiation|stereotactic radiosurgery|
16375194|NCT00081406|Behavioral|Individual Child CBT|
16375195|NCT00081406|Behavioral|Family CBT|
16375196|NCT00081406|Behavioral|Education/Support/Attention|
16375197|NCT00081367|Behavioral|CBT|Participants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed.
16375198|NCT00081367|Behavioral|Standard care alone|Participants will receive standard care for suicide prevention.
16375199|NCT00081328|Drug|Metformin|capsule, 1000 mg bid
16375200|NCT00081328|Drug|Rosiglitazone|capsule, 4 mg bid
16375201|NCT00081328|Behavioral|Lifestyle Program|a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study
16375202|NCT00005872|Drug|rubitecan|
16375203|NCT00005833|Drug|R115777|300mg P.O. BID.
16375204|NCT00005820|Drug|nitrocamptothecin|
16375205|NCT00005801|Biological|therapeutic allogeneic lymphocytes|
16375206|NCT00005801|Procedure|peripheral blood stem cell transplantation|
16375207|NCT00005801|Radiation|radiation therapy|
16375208|NCT00005077|Drug|oxaliplatin|
16375209|NCT00005066|Drug|O6-benzylguanine|
16375210|NCT00005066|Drug|carmustine|
16375211|NCT00005061|Biological|bevacizumab|
16375212|NCT00005058|Procedure|ultrasound imaging|
16375213|NCT00005040|Drug|arsenic trioxide|
16375214|NCT00004885|Drug|FOLFIRI regimen|
16375215|NCT00004885|Drug|fluorouracil|
16375216|NCT00004885|Drug|irinotecan hydrochloride|
16375217|NCT00004885|Drug|leucovorin calcium|
16375218|NCT00004860|Drug|leucovorin calcium|
16375219|NCT00004860|Drug|tegafur-uracil|
16375220|NCT00004238|Drug|pralatrexate|
16375221|NCT00004166|Drug|amifostine trihydrate|
16375222|NCT00004166|Procedure|quality-of-life assessment|
16375223|NCT00004137|Biological|filgrastim|
16375224|NCT00004137|Drug|carboplatin|
16375225|NCT00004137|Drug|paclitaxel|
16375226|NCT00004137|Drug|topotecan hydrochloride|
16375227|NCT00004102|Drug|FOLFOX regimen|
16375228|NCT00004102|Drug|fluorouracil|
16375229|NCT00004102|Drug|leucovorin calcium|
16375230|NCT00004102|Drug|oxaliplatin|
16375231|NCT00004082|Drug|carboplatin|
16375232|NCT00004082|Drug|docetaxel|
16375233|NCT00004082|Drug|gemcitabine hydrochloride|
16375234|NCT00004002|Drug|bortezomib|
16375235|NCT00003911|Radiation|stereotactic radiosurgery|
16375236|NCT00003840|Biological|DTGM fusion protein|
16375237|NCT00081315|Drug|Amifostine|
16375238|NCT00005943|Biological|aldesleukin|
16375239|NCT00005943|Biological|staphylococcal enterotoxin B|
16375240|NCT00003754|Drug|cyclophosphamide|
16375241|NCT00003754|Drug|thalidomide|
16375242|NCT00003710|Drug|irinotecan hydrochloride|Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
16375243|NCT00003710|Drug|mitomycin C|Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
16375244|NCT00003692|Procedure|therapeutic thoracoscopy|
16375245|NCT00003692|Procedure|video-assisted surgery|
16375246|NCT00003642|Drug|cisplatin|
16375247|NCT00003642|Drug|fluorouracil|
16375248|NCT00003642|Radiation|radiation therapy|
16375249|NCT00003446|Drug|fluorouracil|
16375250|NCT00003446|Drug|leucovorin calcium|
16375251|NCT00003446|Drug|trimetrexate glucuronate|
16375252|NCT00003376|Drug|carboplatin|
16375253|NCT00003376|Drug|cisplatin|
16375254|NCT00003376|Drug|doxorubicin hydrochloride|
16375255|NCT00003376|Drug|methotrexate|
16375256|NCT00003376|Drug|paclitaxel|
16375257|NCT00003376|Drug|vinblastine|
16375258|NCT00003316|Drug|gemcitabine hydrochloride|
16375259|NCT00003301|Drug|irinotecan hydrochloride|
16375260|NCT00003232|Drug|clodronate disodium|
16375261|NCT00003232|Drug|mitoxantrone hydrochloride|
16375262|NCT00003232|Drug|prednisone|
16375263|NCT00003232|Procedure|quality-of-life assessment|
16375264|NCT00081302|Biological|cetuximab|
16375265|NCT00081302|Drug|carboplatin|
16375266|NCT00081302|Drug|paclitaxel|
16375267|NCT00081302|Radiation|radiation therapy|
16375268|NCT00081289|Radiation|Radiation Therapy|Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.
16375269|NCT00081289|Drug|Capecitabine 1650 mg/m^2/day|825 mg/m^2 q12 hours (1650 mg/m^2/day) orally 5 days per week during radiotherapy.
16375270|NCT00081289|Drug|Capecitabine 1200 mg/m^2/day|600 mg/m^2 q12 hours(1200 mg/m^2/day) orally 5 days per week during radiotherapy.
16375271|NCT00081289|Drug|Irinotecan|50mg/m^2 IV over 1 hour on days 1, 8, 22, and 29
16375272|NCT00081289|Drug|Oxaliplatin|50mg/m^2 IV over 2 hours on days 1, 8, 15, 22, and 29
16375273|NCT00081289|Procedure|Surgery|All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.
16375274|NCT00081289|Drug|Folinic Acid|400 mg/m^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.
16375275|NCT00081289|Drug|Fluorouracil|"5-fluorouracil bolus 400 mg/m^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles.
~5-fluorouracil infusion 2400 mg/m^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles."
16375276|NCT00081289|Drug|Oxaliplatin|85 mg/m^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.
16375277|NCT00081276|Drug|triapine|Given IV
16375278|NCT00081276|Drug|cisplatin|Given IV
16375279|NCT00081276|Other|laboratory biomarker analysis|Correlative studies
16375280|NCT00081263|Drug|Celecoxib|Given orally
16375281|NCT00081263|Other|Laboratory Biomarker Analysis|Correlative studies
16375282|NCT00081263|Other|Placebo|Given orally
16375283|NCT00081250|Dietary Supplement|creatine monohydrate|Given orally
16375284|NCT00081250|Other|placebo|Given orally
16375285|NCT00081237|Drug|OSI-7904L|
16375286|NCT00081237|Drug|oxaliplatin|
16375287|NCT00081224|Drug|capecitabine|
16375288|NCT00081224|Drug|celecoxib|
16375289|NCT00081224|Radiation|radiation therapy|
16375290|NCT00081224|Procedure|surgery|
16375291|NCT00081211|Biological|PV701|Given intratumorally
16375292|NCT00081172|Radiation|lutetium Lu 177 monoclonal antibody J591|
16375293|NCT00081159|Drug|Doxorubicin hydrochloride|Doxorubicin 20 mg/m^2 is administered intravenously either over 15 to 30 minutes via a peripheral line or over 24 hours via a central line on days 1, 8, and 15 every 28 days for 2 cycles.
16375294|NCT00081159|Drug|Goserelin acetate|
16375295|NCT00081159|Drug|Leuprolide acetate|
16375296|NCT00081159|Drug|Zoledronic acid|4 mg given intravenously over 15 minutes every 28 days for a total of 6 doses.
16375297|NCT00081159|Procedure|orchiectomy|
16375298|NCT00081159|Radiation|strontium chloride Sr|1 dose of strontium-89 (4 millicurie (mCi) total dose) administered intravenously on the first day of treatment
16375299|NCT00081133|Drug|arsenic trioxide|
16375300|NCT00081133|Drug|imatinib mesylate|
16375301|NCT00081107|Drug|epothilone D|
16375302|NCT00081094|Procedure|18F-Fluorodeoxyglucose-PET (FDG-PET)|
16375303|NCT00081094|Procedure|11Carbon-Acetate-PET|
16375304|NCT00081068|Biological|alemtuzumab|
16375305|NCT00081055|Biological|autologous expanded mesenchymal stem cells OTI-010|
16375306|NCT00081055|Drug|busulfan|
16375307|NCT00081055|Drug|cyclophosphamide|
16375308|NCT00081055|Drug|cyclosporine|
16375309|NCT00081055|Drug|methotrexate|
16375310|NCT00081055|Procedure|peripheral blood stem cell transplantation|
16375311|NCT00081055|Radiation|radiation therapy|
16375312|NCT00081042|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16375313|NCT00081029|Procedure|management of therapy complications|
16375314|NCT00081029|Radiation|radiation therapy|
16375315|NCT00081003|Genetic|gene expression analysis|
16375316|NCT00081003|Genetic|protein expression analysis|
16375317|NCT00081003|Other|cytology specimen collection procedure|
16375318|NCT00081003|Other|laboratory biomarker analysis|
16375319|NCT00081003|Other|physiologic testing|
16375320|NCT00081003|Procedure|breast duct lavage|
16375321|NCT00081003|Procedure|endoscopic biopsy|
16375322|NCT00081003|Procedure|study of high risk factors|
16375323|NCT00080990|Drug|alvocidib|Given IV
16375324|NCT00080990|Drug|fluorouracil|Given IV
16375325|NCT00080990|Drug|oxaliplatin|Given IV
16375326|NCT00080990|Drug|leucovorin calcium|Given IV
16375327|NCT00080977|Biological|aldesleukin|
16375328|NCT00080951|Drug|fluorouracil|
16375329|NCT00080951|Drug|irinotecan hydrochloride|
16375330|NCT00080951|Drug|leucovorin calcium|
16375331|NCT00080951|Drug|oxaliplatin|
16375332|NCT00080938|Drug|Temozolomide|Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles.
16375333|NCT00080938|Radiation|Radiation therapy|Standard whole brain radiation therapy 30 Gy in ten fractions.
16375334|NCT00080925|Biological|filgrastim|
16375335|NCT00080925|Biological|graft-versus-tumor induction therapy|
16375336|NCT00080925|Biological|rituximab|
16375337|NCT00080925|Biological|therapeutic allogeneic lymphocytes|
16375338|NCT00080925|Drug|cyclophosphamide|
16375339|NCT00080925|Drug|cyclosporine|
16375340|NCT00080925|Drug|cytarabine|
16375341|NCT00080925|Drug|doxorubicin hydrochloride|
16375342|NCT00080925|Drug|etoposide|
16375343|NCT00080925|Drug|fludarabine phosphate|
16375344|NCT00080925|Drug|prednisone|
16375345|NCT00080925|Drug|vincristine sulfate|
16375346|NCT00080925|Procedure|peripheral blood stem cell transplantation|
16375347|NCT00080912|Radiation|radiation therapy|Given in a single fraction or multiple fractions
16375437|NCT00002997|Procedure|cryosurgery|
16375348|NCT00080899|Drug|fenretinide|Given orally
16375349|NCT00080899|Other|laboratory biomarker analysis|Correlative studies
16375350|NCT00080886|Biological|rituximab|
16375351|NCT00080886|Drug|carmustine|
16375352|NCT00080886|Drug|cytarabine|
16375353|NCT00080886|Drug|etoposide|
16375354|NCT00080886|Drug|melphalan|
16375355|NCT00080886|Procedure|autologous bone marrow transplantation|
16375356|NCT00080886|Procedure|peripheral blood stem cell transplantation|
16375357|NCT00080873|Drug|Traumeel S|
16375358|NCT00080873|Other|Placebo|
16375359|NCT00080860|Genetic|microarray analysis|
16375360|NCT00080860|Other|immunohistochemistry staining method|
16375361|NCT00080860|Procedure|conventional surgery|
16375362|NCT00080860|Procedure|lymphangiography|
16375363|NCT00080860|Procedure|radionuclide imaging|
16375364|NCT00080860|Procedure|sentinel lymph node biopsy|
16375365|NCT00080860|Radiation|technetium Tc 99m sulfur colloid|
16375366|NCT00080847|Biological|oblimersen sodium|Given IV
16375367|NCT00080847|Biological|rituximab|Given IV
16375368|NCT00080847|Drug|cyclophosphamide|Given IV
16375369|NCT00080847|Drug|doxorubicin hydrochloride|Given IV
16375370|NCT00080847|Drug|vincristine sulfate|Given IV
16375371|NCT00080847|Drug|prednisone|Given orally
16375372|NCT00080847|Other|laboratory biomarker analysis|Correlative studies
16375373|NCT00080834|Drug|DJ-927|
16375374|NCT00080808|Drug|Alprostadil (E1)|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
16375375|NCT00080808|Drug|Papaverine|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
16375376|NCT00080808|Drug|Phentolamine mesylate|Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
16375377|NCT00080808|Drug|Sildenafil citrate|Oral sildenafil as needed
16375378|NCT00080808|Procedure|conventional surgery|Unilateral cavernous nerve sparing radical retropubic prostatectomy
16375379|NCT00080795|Biological|filgrastim|
16375380|NCT00080795|Drug|cisplatin|
16375381|NCT00080795|Drug|doxorubicin hydrochloride|
16375382|NCT00080795|Drug|gemcitabine hydrochloride|
16375383|NCT00080795|Drug|ifosfamide|
16375384|NCT00080795|Procedure|conventional surgery|
16375385|NCT00080795|Procedure|neoadjuvant therapy|
16375386|NCT00080782|Drug|Celecoxib|Oral celecoxib twice daily in the absence of disease progression.
16375387|NCT00080782|Drug|Doxorubicin Hydrochloride|By vein (IV) over 30 minutes on days 1, 8, 15, and 22
16375388|NCT00080782|Radiation|Strontium chloride Sr 89|IV on day 1
16375389|NCT00080756|Biological|therapeutic estradiol|0.35mg/100ul per day as a nasal spray
16375390|NCT00080756|Drug|deslorelin|1mg/100ul per day as a nasal spray
16375391|NCT00080756|Drug|therapeutic testosterone|0.275mg/100ul per day as a nasal spray
16375392|NCT00080756|Procedure|therapeutic conventional surgery|Undergo risk reduction mastectomy
16375393|NCT00080756|Other|active surveillance|Undergo continued surveillance
16375394|NCT00080756|Procedure|quality-of-life assessment|Ancillary studies
16375395|NCT00080756|Other|laboratory biomarker analysis|Correlative studies
16375396|NCT00080743|Drug|gefitinib|250 mg po once daily
16375397|NCT00080743|Drug|tamoxifen citrate|20 mg po once daily
16375398|NCT00080743|Drug|Placebo|One pill po once daily
16375399|NCT00080678|Drug|Docetaxel|
16375400|NCT00080678|Drug|Imatinib Mesylate|
16375401|NCT00080665|Drug|docetaxel|Docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle
16375402|NCT00080665|Drug|imatinib mesylate|Imatinib mesylate (400-600 mg, oral, once daily) each 28 day cycle
16375403|NCT00080639|Other|physiologic testing|
16375404|NCT00080639|Procedure|study of high risk factors|
16375405|NCT00080626|Biological|pegfilgrastim|6 mg injection on day 1 of each cycle
16375406|NCT00080626|Drug|docetaxel|100 mg per meter-squared, every 14 days for 4 cycles
16375407|NCT00080626|Procedure|conventional surgery|lumpectomy or mastectomy at end of treatment
16375408|NCT00080626|Procedure|neoadjuvant therapy|treatment prior to definitive breast surgery
16375409|NCT00080613|Drug|exemestane|
16375410|NCT00080613|Procedure|adjuvant therapy|
16375411|NCT00080613|Procedure|aromatase inhibition|
16375412|NCT00080613|Procedure|conventional surgery|
16375413|NCT00080613|Procedure|endocrine therapy|
16375414|NCT00080613|Procedure|hormone therapy|
16375415|NCT00080613|Procedure|neoadjuvant therapy|
16375416|NCT00080613|Procedure|surgery|
16375417|NCT00080574|Procedure|Skin Biopsy|
16375418|NCT00080535|Biological|LMB-2|30 micrograms/kg every other day (QOD) x 3 every 4 weeks
16375419|NCT00080522|Behavioral|Monitoring by HIV-trained primary care nurses|
16375420|NCT00080522|Behavioral|Community-based directly observed therapy (DOT)|
16375421|NCT00080522|Drug|stavudine|
16375422|NCT00080522|Drug|lamivudine|
16375423|NCT00080522|Drug|efavirenz|
16375424|NCT00080522|Drug|zidovudine|
16375425|NCT00080522|Drug|didanosine|
16375426|NCT00080522|Drug|lopinavir/ritonavir|
16375427|NCT00080509|Drug|KOS-862|
16375428|NCT00080496|Drug|Tigecycline|
16375429|NCT00080496|Drug|Imipenem|
16375430|NCT00080496|Drug|Cilastatin|
16375431|NCT00003176|Drug|carmustine|
16375432|NCT00003176|Drug|temozolomide|
16375433|NCT00003156|Drug|topotecan hydrochloride|
16375434|NCT00003132|Drug|bryostatin 1|
16375435|NCT00003132|Drug|cisplatin|
16375436|NCT00003110|Biological|bleomycin sulfate|Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs.
16375438|NCT00080483|Drug|Testosterone plus somatropin|AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
16375439|NCT00080483|Drug|testosterone|AndroGel transdermally 5 g a day for two years
16375440|NCT00024063|Drug|orantinib|
16375441|NCT00003107|Biological|recombinant interleukin-12|
16375442|NCT00003103|Biological|oblimersen sodium|
16375443|NCT00003103|Drug|docetaxel|
16375444|NCT00003012|Drug|CMF regimen|
16375445|NCT00003012|Drug|cyclophosphamide|
16375446|NCT00003012|Drug|epirubicin hydrochloride|
16375447|NCT00003012|Drug|fluorouracil|
16375448|NCT00003012|Drug|methotrexate|
16375449|NCT00002987|Biological|bleomycin sulfate|
16375450|NCT00002987|Drug|cyclophosphamide|
16375451|NCT00002987|Drug|doxorubicin hydrochloride|
16375452|NCT00002987|Drug|etoposide|
16375453|NCT00002987|Drug|prednisolone|
16375454|NCT00002987|Drug|vincristine sulfate|
16375455|NCT00002987|Radiation|radiation therapy|
16375456|NCT00002814|Biological|filgrastim|
16375457|NCT00002814|Drug|paclitaxel|
16375458|NCT00002814|Drug|topotecan hydrochloride|
16375459|NCT00002774|Drug|Tirapazamine|"Tirapazamine is a benzotriazine with selective cytotoxicity for hypoxic cells. Under hypoxic conditions, it undergoes a 1-electron reduction to form a cytotoxic free radical that poisons topoisomerase II and causes DNA breaks, chromosomal aberrations, and cell death.
~Tirapazamine was administered on Days 1 and 22 prior to the administration of neoadjuvant cisplatin and on Days 43, 45, 47, 71, 73, and 75 within 1 or 2 hours prior to each simultaneous cisplatin dose.
~Tirapazamine dose was as follows:
~Level 1 - 300 mg/m2 during the induction phase and 160 mg/m2 during the simultaneous phase (n = 4)
~Level 2 - 330 mg/m2 during the induction phase and 260 mg/m2 during the simultaneous phase (n = 4)
~Level 3 - 300 mg/m2 during the induction phase and 220 mg/m2 during the simultaneous phase (n = 25)"
16375460|NCT00002774|Drug|Cisplatin|The simultaneous chemoradiotherapy (CRT) regimen included cisplatin 20 mg/m2 administered 3 times per week.
16375461|NCT00002774|Drug|5-fluorouracil|"100 mg/m2 per day on Days 1 and 22, and continuous infusion (CI) 5-FU at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on Days 1 and 22.
~The simultaneous chemoradiotherapy (CRT) regimen included continuous infusion (CI) 5-FU 600 mg/m2 per day for 96 hours per cycle in Weeks 1 and 5 of RT."
16375462|NCT00002774|Radiation|Radiotherapy (RT)|"During the CRT regimen, RT was given within 3 hrs of the tirapazamine infusion. The dose for the parallel opposed fields was 2 Gy/fraction/day given 5 dys/week up to a total dose of 66-70 Gy at the target lesion. The dose to the supraclavicular region was 50 Gy at a depth of 3 cm, delivered in 25 fractions. Supervoltage photons (≥4 megavolts) were used to treat both locations.
~After 50 Gy were delivered to the primary site and regional lymph nodes, all sites were reassessed for clinical response by physical exam, direct fiber optic evaluation, and radiographic imaging (CT or MRI).
~Subjects with a CR at both the primary site and the neck completed RT treatment to a total dose ≥66 Gy to the primary site and the involved lymph node(s). Subjects with a CR at the primary site but a partial response (PR) at the neck completed RT treatment to the primary site followed by neck dissection. Subjects with a PR at the primary site stopped radiation at 50 Gy and underwent salvage surgery."
16375463|NCT00002714|Biological|bleomycin sulfate|
16375464|NCT00002714|Drug|Stanford V regimen|
16375465|NCT00002714|Drug|doxorubicin hydrochloride|
16375466|NCT00002714|Drug|etoposide|
16375467|NCT00002714|Drug|mechlorethamine hydrochloride|
16375468|NCT00002714|Drug|prednisone|
16375469|NCT00002714|Drug|vinblastine sulfate|
16375470|NCT00002714|Drug|vincristine sulfate|
16375471|NCT00002714|Radiation|radiation therapy|
16375472|NCT00002600|Biological|filgrastim|
16375473|NCT00002600|Drug|carboplatin|
16375474|NCT00002600|Drug|cyclophosphamide|
16375475|NCT00002600|Procedure|autologous bone marrow transplantation|
16375476|NCT00002600|Procedure|peripheral blood stem cell transplantation|
16375477|NCT00002525|Drug|fluorouracil|"Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery
~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5"
16375478|NCT00002525|Drug|leucovorin calcium|given after surgery at dose of 20mg/m^2 IV push on days 1-5
16375479|NCT00002494|Drug|cyclophosphamide|
16375480|NCT00002494|Drug|cytarabine|
16375481|NCT00002494|Drug|dexamethasone|
16375482|NCT00002494|Drug|doxorubicin hydrochloride|
16375483|NCT00002494|Drug|etoposide|
16375484|NCT00002494|Drug|ifosfamide|
16375485|NCT00002494|Drug|leucovorin calcium|
16375486|NCT00002494|Drug|mesna|
16375487|NCT00002494|Drug|methotrexate|
16375488|NCT00002494|Drug|prednisone|
16375489|NCT00002494|Drug|therapeutic hydrocortisone|
16375490|NCT00002494|Drug|vincristine sulfate|
16375491|NCT00002494|Radiation|low-LET cobalt-60 gamma ray therapy|
16375492|NCT00002494|Radiation|low-LET photon therapy|
16375493|NCT00080470|Device|bion|battery powered microstimulator
16375494|NCT00080457|Drug|sitaxsentan sodium|
16375495|NCT00023816|Drug|carbendazim|
16375496|NCT00022386|Biological|epoetin alfa|
16375497|NCT00022386|Procedure|quality-of-life assessment|
16375498|NCT00022256|Drug|motexafin gadolinium|
16375499|NCT00022256|Radiation|radiation therapy|
16375500|NCT00020605|Drug|naloxone hydrochloride|
16375501|NCT00020540|Biological|recombinant CD40-ligand|
16375502|NCT00020540|Biological|recombinant flt3 ligand|
16375503|NCT00019071|Drug|chemotherapy|
16375504|NCT00019071|Drug|cladribine|
16375505|NCT00019071|Radiation|radiation therapy|
16375506|NCT00019058|Drug|chemotherapy|
16375507|NCT00019058|Drug|hydroxyurea|
16375508|NCT00019058|Drug|pentoxifylline|
16375509|NCT00019058|Radiation|radiation therapy|
16375510|NCT00016042|Biological|lymphokine-activated killer cells|
16375511|NCT00016042|Biological|recombinant interferon alfa|
16375512|NCT00016042|Biological|sargramostim|
16375513|NCT00016042|Drug|fluorouracil|
16375514|NCT00014573|Biological|aldesleukin|
16375515|NCT00014573|Biological|autologous tumor cell vaccine|
16375516|NCT00014573|Biological|filgrastim|
16375517|NCT00014573|Biological|sargramostim|
16375518|NCT00014573|Biological|therapeutic autologous lymphocytes|
16375519|NCT00014573|Drug|carmustine|
16375520|NCT00014573|Drug|cisplatin|
16375521|NCT00014573|Drug|cyclophosphamide|
16375522|NCT00014573|Drug|paclitaxel|
16375523|NCT00014573|Procedure|autologous bone marrow transplantation|
16375524|NCT00014573|Procedure|conventional surgery|
16375525|NCT00014573|Procedure|peripheral blood stem cell transplantation|
16375526|NCT00080444|Drug|aprepitant|aprepitant capsules
16375527|NCT00080444|Drug|ondansetron|ondansetron IV preparation
16375528|NCT00080444|Drug|dexamethasone|dexamethasone tablets
16375529|NCT00080444|Drug|placebo to aprepitant|Matching placebo to aprepitant capsules
16375530|NCT00080444|Drug|placebo to dexamethasone|Matching placebo to dexamethasone tablets
16375531|NCT00080444|Drug|rescue medication|Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.
16375532|NCT00080418|Drug|Liposome Entrapped Paclitaxel Easy to Use|
16375533|NCT00080405|Drug|Bortezomib|
16375534|NCT00009841|Biological|EGFR antisense DNA|
16375535|NCT00009841|Biological|growth factor antagonist therapy|
16375536|NCT00009841|Drug|DC-cholesterol liposome|
16375537|NCT00007813|Biological|filgrastim|
16375538|NCT00007813|Drug|carboplatin|
16375539|NCT00007813|Drug|cyclophosphamide|
16375540|NCT00007813|Drug|etoposide|
16375541|NCT00007813|Procedure|autologous bone marrow transplantation|
16375542|NCT00007813|Procedure|peripheral blood stem cell transplantation|
16375543|NCT00006487|Drug|cisplatin|"During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
~During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion."
16375544|NCT00006487|Drug|etoposide|"During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion
~During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion."
16375545|NCT00006487|Drug|tirapazamine|"During induction:
~Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
~Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion
~During consolidation:
~330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion."
16375546|NCT00006487|Radiation|radiation therapy|Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
16375547|NCT00006458|Radiation|indium In 111 monoclonal antibody MN-14|
16375548|NCT00006458|Radiation|yttrium Y 90 monoclonal antibody MN-14|
16375549|NCT00006376|Drug|chemotherapy|
16375550|NCT00006376|Drug|tipifarnib|
16375551|NCT00006371|Drug|aminoglutethimide|
16375552|NCT00006371|Drug|ketoconazole|
16375553|NCT00006371|Drug|therapeutic hydrocortisone|
16375554|NCT00006370|Radiation|yttrium Y 90-edotreotide|
16375555|NCT00006369|Drug|ERA-923|
16375556|NCT00006368|Radiation|yttrium Y 90-edotreotide|
16375557|NCT00006052|Drug|imatinib mesylate|
16375558|NCT00006043|Drug|temozolomide|
16375559|NCT00006032|Drug|etoposide|
16375560|NCT00006032|Drug|ifosfamide|
16375561|NCT00006032|Drug|topotecan hydrochloride|
16375562|NCT00006032|Procedure|peripheral blood stem cell transplantation|
16375563|NCT00006031|Procedure|Needle localized breast biopsy with specimen x-ray|
16375564|NCT00006031|Procedure|Low dose radioactive seed followed by surgery and mammogram|either iodine I 125 or palladium Pd 103
16375565|NCT00005948|Biological|aldesleukin|
16375566|NCT00005948|Biological|recombinant interferon alfa|
16375567|NCT00005948|Biological|sargramostim|
16375568|NCT00005948|Drug|busulfan|
16375569|NCT00005948|Procedure|peripheral blood stem cell transplantation|
16375570|NCT00005860|Drug|floxuridine|
16375571|NCT00005860|Drug|leucovorin calcium|
16375572|NCT00005860|Drug|oxaliplatin|
16375573|NCT00005799|Drug|fludarabine phosphate|Given IV
16375574|NCT00005799|Radiation|total-body irradiation|Undergo low-dose TBI
16375575|NCT00005799|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative HSCT
16375576|NCT00005799|Procedure|allogeneic bone marrow transplantation|Undergo nonmyeloablative allogeneic bone marrow transplantation
16375577|NCT00005799|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
16375578|NCT00005799|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
16375579|NCT00005799|Drug|cyclosporine|Given PO
16375580|NCT00005799|Drug|mycophenolate mofetil|Given PO
16375581|NCT00005799|Other|pharmacological study|Correlative studies
16375582|NCT00005799|Other|laboratory biomarker analysis|Correlative studies
16375583|NCT00005798|Drug|Carboplatin|Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2)
16375584|NCT00005798|Drug|Cyclophosphamide|Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2)
16375585|NCT00005798|Drug|Thiotepa|Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )
16375586|NCT00005628|Biological|vitespen|
16375587|NCT00005618|Drug|arsenic trioxide|
16375588|NCT00005615|Biological|Interferon alfa|Interferon alfa as outlined in treatment arm.
16375589|NCT00005615|Radiation|Radiation therapy|Radiation therapy as outlined in treatment arm.
16375590|NCT00005577|Drug|gemcitabine hydrochloride|
16375591|NCT00005097|Drug|Polyphenon E and Placebo|Areas of sun damaged skin with actinic keratoses to be treated will be mapped and photographed on patient's bilateral arms. One of the patient's arms will be assigned to be treated with topical Polyphenon E, the patient's other arm with placebo vehicle in a random, double blind manner. The patient's arm treatment areas will receive daily applications of a premeasured amount of drug or placebo. Patients will be seen every other week for 12 weeks to check for effects of the applications and monitor for compliance or possible side effects.
16375592|NCT00005068|Drug|fluorouracil|
16375593|NCT00005068|Drug|irinotecan hydrochloride|
16375594|NCT00005068|Drug|leucovorin calcium|
16375595|NCT00005068|Drug|oxaliplatin|
16375596|NCT00003864|Drug|carboplatin|
16375597|NCT00003864|Drug|docetaxel|
16375598|NCT00080431|Drug|Daclizumab|
16375599|NCT00005031|Drug|irofulven|
16375600|NCT00004248|Biological|aldesleukin|
16375601|NCT00004248|Drug|doxorubicin hydrochloride|
16375602|NCT00004097|Drug|fluorouracil|
16375603|NCT00004097|Drug|gemcitabine hydrochloride|
16375604|NCT00004097|Drug|paclitaxel|
16375605|NCT00004097|Radiation|radiation therapy|
16375606|NCT00003967|Drug|etoposide|
16375607|NCT00003967|Drug|topotecan hydrochloride|
16375608|NCT00003883|Drug|fluconazole|
16375609|NCT00003883|Drug|itraconazole|
16375610|NCT00003769|Drug|perillyl alcohol|
16375611|NCT00003769|Procedure|surgical procedure|
16375612|NCT00003657|Biological|filgrastim|
16375613|NCT00003657|Drug|Amifostine|
16375614|NCT00003657|Drug|Carboplatin|
16375615|NCT00003657|Drug|Etoposide|
16375616|NCT00003657|Drug|Ifosfamide|
16375617|NCT00003657|Procedure|peripheral blood stem cell transplantation|
16375618|NCT00003635|Drug|nelarabine|
16375619|NCT00003412|Biological|recombinant interleukin-12|
16375620|NCT00003402|Drug|carmustine|
16375621|NCT00003402|Drug|cisplatin|
16375622|NCT00003402|Drug|cyclophosphamide|
16375623|NCT00003402|Drug|dexamethasone|
16375624|NCT00003402|Drug|etoposide|
16375625|NCT00003402|Drug|melphalan|
16375626|NCT00003402|Drug|paclitaxel|
16375627|NCT00003402|Procedure|bone marrow ablation with stem cell support|
16375628|NCT00003402|Procedure|peripheral blood stem cell transplantation|
16375629|NCT00080392|Drug|DNA Plasmid Vector|
16375630|NCT00080392|Drug|EW-A-401 DNA Plasmid Vector|
16375631|NCT00080340|Drug|TLK286 (Telcyta) HCl for Injection|
16375632|NCT00080340|Drug|gefitinib (Iressa)|
16375633|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 2mg, Once daily, 6 weeks.
16375634|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 5mg, Once daily, 6 weeks.
16375635|NCT00080327|Drug|Aripiprazole|Tablets, Oral, 10mg, Once daily, 6 weeks.
16375636|NCT00080327|Drug|Placebo|Tablets, Oral, 0mg, Once daily, 6 weeks.
16375637|NCT00080314|Drug|Aripiprazole|Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
16375638|NCT00080314|Drug|Placebo|Tablets, Oral, 0 mg, Once daily, 8 weeks.
16375639|NCT00080301|Drug|Ixabepilone + Capecitabine|"Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
~Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity"
16375640|NCT00080301|Drug|Capecitabine|Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
16375641|NCT00003345|Drug|cisplatin|
16375642|NCT00003345|Drug|irinotecan hydrochloride|
16375643|NCT00003192|Drug|aminocamptothecin|
16375644|NCT00003157|Drug|cisplatin|
16375645|NCT00003157|Drug|gemcitabine hydrochloride|
16375646|NCT00003157|Radiation|radiation therapy|
16375647|NCT00003149|Biological|recombinant interleukin-12|
16375648|NCT00002974|Drug|carboplatin|
16375649|NCT00002974|Drug|etoposide|
16375650|NCT00002974|Drug|ifosfamide|
16375651|NCT00002974|Procedure|hyperthermia treatment|
16375652|NCT00080366|Drug|1-Octanol|
16375653|NCT00080353|Drug|IL-2|
16375654|NCT00080353|Drug|gp100:209-217|
16375655|NCT00080353|Drug|OKT3|
16375656|NCT00080353|Drug|rF-go 100P209|
16375657|NCT00080353|Drug|Montanide ISA 51|
16375658|NCT00080288|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
16375659|NCT00080288|Drug|Placebo|Matching placebo tablets once daily
16375660|NCT00080275|Drug|Niacin Extended-Release and simvastatin Tablets|
16375661|NCT00080262|Drug|Ixabepilone|Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
16375662|NCT00080236|Drug|IDN-6556|
16375663|NCT00080236|Drug|Placebo|
16375664|NCT00080223|Drug|Pirfenidone|up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
16375665|NCT00080158|Drug|fluoxetine|
16375666|NCT00080158|Drug|sertraline|
16375667|NCT00080158|Drug|citalopram|
16375668|NCT00080158|Drug|escitalopram|
16375669|NCT00080158|Drug|bupropion|
16375670|NCT00080158|Drug|mirtazapine|
16375671|NCT00080158|Drug|venlafaxine|
16375672|NCT00080158|Drug|lithium|
16375673|NCT00080158|Behavioral|Cognitive Behavioral Therapy|
16375674|NCT00012142|Drug|temsirolimus|
16375675|NCT00002950|Biological|sargramostim|
16375676|NCT00002950|Drug|topotecan hydrochloride|
16375677|NCT00002947|Radiation|indium In 111 pentetreotide|
16375678|NCT00002887|Drug|cisplatin|
16375679|NCT00002887|Drug|etoposide|
16375680|NCT00002887|Drug|hydroxyurea|
16375681|NCT00002887|Drug|vinblastine sulfate|
16375682|NCT00002887|Drug|vindesine|
16375683|NCT00002887|Drug|vinorelbine tartrate|
16375684|NCT00002887|Procedure|drug resistance inhibition treatment|
16375685|NCT00002759|Drug|cyclosporine|
16375686|NCT00002759|Drug|irinotecan hydrochloride|
16375687|NCT00002759|Drug|phenobarbital|
16375688|NCT00002592|Biological|c-myb antisense oligonucleotide G4460|
16375689|NCT00002592|Biological|filgrastim|
16375690|NCT00002592|Drug|busulfan|
16375691|NCT00002592|Drug|cyclophosphamide|
16375692|NCT00002592|Procedure|autologous bone marrow transplantation|
16375693|NCT00002592|Procedure|in vitro-treated bone marrow transplantation|
16375694|NCT00002540|Other|Laboratory Biomarker Analysis|Correlative studies
16375695|NCT00002540|Procedure|Medical Examination|Undergo DRE
16375696|NCT00002540|Other|Screening Questionnaire Administration|Undergo questionnaire assessments
16375697|NCT00002536|Drug|cisplatin|
16375698|NCT00002536|Drug|vincristine sulfate|
16375699|NCT00002536|Procedure|surgical procedure|
16375700|NCT00002536|Radiation|radiation therapy|
16375701|NCT00002461|Biological|filgrastim|
16375702|NCT00002461|Biological|sargramostim|
16375703|NCT00002461|Drug|carmustine|
16375704|NCT00002461|Drug|cisplatin|
16375705|NCT00002461|Drug|cyclophosphamide|
16375706|NCT00002461|Drug|etoposide|
16375707|NCT00002461|Procedure|autologous bone marrow transplantation|
16375708|NCT00002461|Procedure|in vitro-treated bone marrow transplantation|
16375709|NCT00002461|Procedure|peripheral blood stem cell transplantation|
16375710|NCT00002461|Radiation|radiation therapy|
16375711|NCT00080210|Drug|Puricase|
16375712|NCT00080197|Drug|E7070|
16375713|NCT00080184|Procedure|Low Energy Neurofeedback System|
16375714|NCT00080145|Drug|Risperidone|
16375715|NCT00080145|Behavioral|Behavior Therapy|
16375716|NCT00080132|Drug|implitapide|
16375717|NCT00080119|Drug|Isoniazid (INH)|Antibiotic for the prevention and treatment of TB
16375718|NCT00080119|Drug|Trimethoprim/Sulfamethoxazole (TMP/SMX)|Antibiotic for the prevention and treatment of pneumocystis pneumonia (PCP)
16375719|NCT00080119|Drug|Isoniazid Placebo (PL)|Isoniazid placebo and TMP/SMX
16375720|NCT00080106|Biological|MRK Ad5 HIV-1 gag vaccine|MRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle.
16375721|NCT00080106|Other|Vaccine placebo|MRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle.
16375722|NCT00010647|Procedure|Acupuncture|
16375723|NCT00008320|Drug|ceramide|
16375724|NCT00008151|Drug|cyclosporine|
16375725|NCT00008151|Drug|fludarabine phosphate|
16375726|NCT00008151|Drug|gemtuzumab ozogamicin|
16375727|NCT00008151|Drug|methotrexate|
16375728|NCT00008151|Drug|mycophenolate mofetil|
16375729|NCT00008151|Procedure|allogeneic bone marrow transplantation|
16375730|NCT00008151|Procedure|peripheral blood stem cell transplantation|
16375731|NCT00008151|Radiation|radiation therapy|
16375732|NCT00006348|Drug|ondansetron|
16375733|NCT00006348|Other|placebo|
16375734|NCT00006345|Biological|denileukin diftitox|
16375735|NCT00006345|Drug|dexamethasone|
16375736|NCT00006262|Drug|becatecarin|
16375737|NCT00006090|Drug|arsenic trioxide|
16375738|NCT00006084|Biological|lintuzumab|
16375739|NCT00006051|Drug|cisplatin|
16375740|NCT00006051|Drug|fluorouracil|
16375741|NCT00006051|Radiation|radiation therapy|
16375742|NCT00006036|Drug|cisplatin|
16375743|NCT00006036|Drug|lurtotecan liposome|
16375744|NCT00006030|Drug|tamoxifen citrate|
16375745|NCT00006030|Procedure|conventional surgery|
16375746|NCT00006030|Radiation|radiation therapy|
16375747|NCT00080093|Behavioral|Individual feedback and specially-tailored manuals|Individual feedback and specially-tailored manuals
16375748|NCT00080093|Behavioral|General HIV information feedback and the best-available information|General HIV information feedback and the best-available information
16375749|NCT00080080|Drug|talabostat (PT-100) tablets|
16375750|NCT00080080|Drug|Docetaxel|
16375751|NCT00006023|Drug|capecitabine|
16375752|NCT00005992|Biological|PSA prostate cancer vaccine|
16375753|NCT00005992|Biological|therapeutic autologous dendritic cells|
16375754|NCT00005972|Drug|gemcitabine hydrochloride|
16375755|NCT00005972|Drug|irinotecan hydrochloride|
16375756|NCT00005944|Drug|chemotherapy|
16375757|NCT00005944|Drug|fluorouracil|
16375758|NCT00005944|Drug|leucovorin calcium|
16375759|NCT00005944|Drug|mitomycin C|
16375760|NCT00005944|Procedure|conventional surgery|
16375761|NCT00005944|Procedure|laparoscopic surgery|
16375762|NCT00005865|Drug|vinorelbine tartrate|
16375763|NCT00080054|Drug|Motexafin Gadolinium Injection|
16375764|NCT00080041|Drug|Motexafin Gadolinium Injection|
16375765|NCT00080028|Drug|Motexafin Gadolinium Injection|
16375766|NCT00080015|Drug|Diflomotecan (BN80915)|
16375767|NCT00080002|Drug|Pegamotecan|
16375768|NCT00079989|Drug|tigecycline|
16375769|NCT00005816|Biological|therapeutic autologous dendritic cells|
16375770|NCT00005816|Procedure|conventional surgery|
16375771|NCT00004123|Drug|Doxorubicin hydrochloride (DOX)|Doxorubicin IV bolus followed immediately by IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks.
16375772|NCT00004123|Procedure|Conventional surgery|Surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after chemoradiotherapy
16375773|NCT00004123|Radiation|Intraoperative radiation therapy (IORT)|Intraoperative radiotherapy (IORT) to tumor bed if all gross disease has been resected and if area of maximal tumor adherence to retroperitoneum can be encompassed within a single IORT field (maximum 15 cm).
16375774|NCT00004123|Radiation|Radiation Therapy (RT)|5 days a week for 4 weeks
16375775|NCT00003817|Drug|dolasetron mesylate|
16375776|NCT00003817|Drug|granisetron hydrochloride|
16375777|NCT00003817|Drug|ondansetron|
16375778|NCT00003817|Drug|tropisetron|
16375779|NCT00003817|Procedure|quality-of-life assessment|
16375780|NCT00003693|Drug|Dolastatin 10|IV bolus once every 3 weeks.
16375781|NCT00003647|Drug|allovectin-7|
16375782|NCT00003647|Drug|allovectin-7/dacarbazine|
16375783|NCT00003647|Drug|dacarbazine|
16375784|NCT00079976|Drug|Tigecycline|
16375785|NCT00079963|Dietary Supplement|Vitamin C|1000 mg/day
16375786|NCT00079963|Dietary Supplement|Vitamin E|800 IU/day
16375787|NCT00079963|Dietary Supplement|Placebo|
16375788|NCT00079950|Drug|Pegamotecan|
16375789|NCT00079937|Drug|Omalizumab|The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.
16375790|NCT00079937|Drug|Placebo|Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.
16375791|NCT00079937|Drug|Fluticasone|Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
16375792|NCT00003561|Biological|recombinant interferon alfa|
16375793|NCT00003561|Biological|sargramostim|
16375794|NCT00003356|Biological|aldesleukin|
16375795|NCT00003356|Biological|rituximab|
16375796|NCT00003327|Drug|paclitaxel|
16375797|NCT00003321|Procedure|psychosocial assessment and care|
16375798|NCT00003321|Procedure|quality-of-life assessment|
16375799|NCT00003274|Biological|gp100 antigen|
16375800|NCT00003274|Biological|incomplete Freund's adjuvant|
16375801|NCT00003274|Biological|sargramostim|
16375802|NCT00003274|Biological|tyrosinase peptide|
16375803|NCT00079924|Drug|teriparatide|
16375804|NCT00079924|Drug|aldrenodate|
16375805|NCT00079924|Drug|raloxifene|
16375806|NCT00079911|Drug|valacyclovir hydrochloride|valacyclovir hydrochloride
16375807|NCT00079898|Procedure|Acupuncture|
16375808|NCT00079885|Drug|tigecycline|
16375809|NCT00079872|Drug|Pemetrexed|
16375810|NCT00022360|Drug|taurolidine|
16375811|NCT00022165|Dietary Supplement|selenium|
16375812|NCT00021138|Behavioral|smoking cessation intervention|
16375813|NCT00021138|Drug|nicotine|
16375814|NCT00003166|Drug|bryostatin 1|Given IV
16375815|NCT00003166|Drug|vincristine sulfate|Given IV
16375816|NCT00003166|Other|laboratory biomarker analysis|Correlative studies
16375817|NCT00002789|Drug|busulfan|
16375818|NCT00002789|Drug|cyclophosphamide|
16375819|NCT00002789|Drug|cyclosporine|
16375820|NCT00002789|Drug|methotrexate|
16375821|NCT00002789|Procedure|allogeneic bone marrow transplantation|
16375822|NCT00002789|Procedure|peripheral blood stem cell transplantation|
16375823|NCT00079859|Drug|Implitapide|
16375824|NCT00079846|Drug|Implitapide|
16375825|NCT00079833|Drug|Esomeprazole magnesium (Nexium)|
16375826|NCT00079820|Biological|ACAM3000 MVA Vaccine|Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
16375827|NCT00020930|Biological|cetuximab|
16375828|NCT00020865|Drug|cefepime hydrochloride|
16375829|NCT00020865|Drug|levofloxacin|
16375830|NCT00014300|Drug|glufosfamide|
16375831|NCT00012337|Drug|gefitinib|
16375832|NCT00009737|Drug|5-Fluorouracil|425mg/m2 iv daily from day 1 to day 5 every 28 days.
16375833|NCT00009737|Drug|Leucovorin|20mg/m2 iv daily from day 1 to day 5 every 28 days.
16375834|NCT00009737|Drug|Capecitabine [Xeloda]|1250mg/m2 po bid on days 1-14 every 21 days.
16375835|NCT00006812|Drug|capecitabine|
16375836|NCT00006708|Biological|filgrastim|5 μg/kg/day subcutaneous injection on Days 5-12 every 21 days for 3 cycles.
16375837|NCT00006708|Biological|rituximab|
16375838|NCT00006708|Drug|carboplatin|
16375839|NCT00006708|Drug|etoposide|
16375840|NCT00006708|Drug|ifosfamide|
16375841|NCT00006218|Drug|triapine|
16375842|NCT00006215|Biological|filgrastim|
16375843|NCT00006215|Drug|docetaxel|
16375844|NCT00006215|Drug|vinorelbine tartrate|
16375845|NCT00006098|Drug|bortezomib|
16375846|NCT00079807|Drug|Alpha-Lipoic Acid|
16375847|NCT00079794|Drug|Iscar|
16375848|NCT00079794|Drug|mistletoe|
16375849|NCT00079781|Procedure|RNS® System implantation|Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
16375850|NCT00079781|Device|RNS® System responsive stimulation|The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
16375851|NCT00079755|Drug|SGN-30 (anti-CD30 mAb)|
16375852|NCT00079742|Drug|Nutropin AQ [somatropin (DNA origin) injection]|
16375853|NCT00079716|Drug|SGN-40 (anti-huCD40 mAb)|0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
16375854|NCT00006091|Drug|arsenic trioxide|
16375855|NCT00006085|Drug|CP-609,754|
16375856|NCT00006026|Drug|rubitecan|
16375857|NCT00005866|Drug|busulfan|arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
16376496|NCT00003299|Drug|cisplatin|
16375858|NCT00005866|Drug|cyclophosphamide|arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
16375859|NCT00005866|Drug|cyclosporine|both arms per published schedule
16375860|NCT00005866|Drug|methotrexate|GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
16375861|NCT00005866|Procedure|allogeneic bone marrow transplantation|day 0
16375862|NCT00005866|Radiation|radiation therapy|both arms: 1200 cGy total dose (6 x 200 fractions)
16375863|NCT00005848|Drug|chemotherapy|
16375864|NCT00005848|Drug|tipifarnib|
16375865|NCT00005834|Biological|filgrastim|Arms 1 and 2: 300 mcg (pts </= 60 kg) or 480 mcg (pts > 60 kg), SC beginning day 5
16375866|NCT00005834|Drug|cisplatin|Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
16375867|NCT00005834|Drug|cyclophosphamide|Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
16375868|NCT00005834|Drug|dexamethasone|Arms 1 and 2: 40 mg/d PO days 1-4
16375869|NCT00005834|Drug|etoposide|Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
16375870|NCT00005834|Drug|thalidomide|Arm 2: 800 mg/d (max dose) PO daily
16375871|NCT00005635|Biological|trastuzumab|
16375872|NCT00005635|Drug|paclitaxel|
16375873|NCT00005085|Drug|becatecarin|
16375874|NCT00005037|Drug|temozolomide|
16375875|NCT00005037|Drug|Temozolomide|Temozolomide capsule once a day for 42 days every 10 weeks.
16375876|NCT00004926|Dietary Supplement|vitamin D3 analogue ILX23-7553|
16375877|NCT00004913|Drug|cisplatin|
16375878|NCT00004913|Drug|docetaxel|
16375879|NCT00004913|Drug|fluorouracil|
16375880|NCT00004913|Drug|leucovorin calcium|
16375881|NCT00004865|Biological|cetuximab|
16375882|NCT00004865|Drug|cisplatin|
16375883|NCT00004865|Drug|fluorouracil|
16375884|NCT00004865|Drug|paclitaxel|
16375885|NCT00004864|Drug|GEM 231|
16375886|NCT00004864|Drug|docetaxel|
16375887|NCT00004863|Drug|GEM 231|
16375888|NCT00004863|Drug|paclitaxel|
16375889|NCT00004163|Drug|Trastuzumab|
16375890|NCT00004151|Drug|acridine carboxamide|
16375891|NCT00004142|Drug|Floxuridine|Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.
16375892|NCT00004142|Drug|Fluorouracil (5-FU)|Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.
16375893|NCT00004142|Procedure|Conventional surgery|Open laparotomy to identify target tumor in liver using intraoperative ultrasound.
16375894|NCT00004142|Procedure|Radiofrequency ablation|Radiofrequency tissue ablation over 20 minutes to each tumor.
16375895|NCT00004109|Drug|Doxorubicin Hydrochloride|Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
16375896|NCT00004109|Radiation|Radiation Therapy (RT)|External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
16375897|NCT00003959|Biological|ras peptide cancer vaccine|
16375898|NCT00003959|Biological|sargramostim|
16375899|NCT00003779|Biological|Connaught|Compare two strains of BCG
16375900|NCT00003779|Biological|Tice|Compare two strains of BCG
16375901|NCT00003772|Procedure|quality-of-life assessment|
16375902|NCT00003742|Drug|cisplatin|
16375903|NCT00003742|Drug|irinotecan hydrochloride|
16375904|NCT00003742|Drug|paclitaxel|
16375905|NCT00003706|Drug|pemetrexed disodium|
16375906|NCT00003705|Drug|BMS-184476|
16375907|NCT00003704|Drug|capecitabine|
16375908|NCT00003704|Radiation|radiation therapy|
16375909|NCT00003703|Drug|SarCNU|
16375910|NCT00003695|Drug|chemotherapy|
16375911|NCT00003695|Procedure|surgical procedure|
16375912|NCT00079768|Drug|Alemtuzumab (Campath)|
16375913|NCT00079677|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg once daily in the morning
16375914|NCT00079677|Drug|Placebo|Matching placebo tablets once daily
16375915|NCT00079664|Behavioral|Tai Chi|
16375916|NCT00079651|Behavioral|Montessori-based dementia programming|
16375917|NCT00079638|Drug|Niacin|
16375918|NCT00079638|Drug|Atorvastatin|
16375919|NCT00079638|Drug|Simvastatin|
16375920|NCT00079638|Drug|Ezetimibe|
16375921|NCT00079638|Drug|Rosuvastatin|
16375922|NCT00078039|Drug|Paliperidone ER|
16375923|NCT00003617|Drug|chlorambucil|
16375924|NCT00003617|Drug|clarithromycin|
16375925|NCT00003617|Drug|omeprazole|
16375926|NCT00003617|Drug|tinidazole|
16375927|NCT00003465|Drug|temozolomide|
16375928|NCT00003421|Biological|bleomycin sulfate|
16375929|NCT00003421|Drug|ABVD regimen|
16375930|NCT00003421|Drug|chlorambucil|
16375931|NCT00003421|Drug|dacarbazine|
16375932|NCT00003421|Drug|doxorubicin hydrochloride|
16375933|NCT00003421|Drug|etoposide|
16375934|NCT00003421|Drug|prednisolone|
16375935|NCT00003421|Drug|procarbazine hydrochloride|
16375936|NCT00003421|Drug|vinblastine sulfate|
16375937|NCT00003421|Drug|vincristine sulfate|
16375938|NCT00003421|Radiation|radiation therapy|
16375939|NCT00003368|Drug|irinotecan hydrochloride|
16375940|NCT00003361|Drug|decitabine|
16375941|NCT00003338|Procedure|immunoscintigraphy|
16375942|NCT00003338|Radiation|technetium Tc 99m epratuzumab|
16375943|NCT00003337|Procedure|immunoscintigraphy|
16375944|NCT00003337|Radiation|technetium Tc 99m epratuzumab|
16375945|NCT00003212|Drug|doxorubicin hydrochloride|
16375946|NCT00003212|Drug|ifosfamide|
16375947|NCT00003021|Drug|bizelesin|
16375948|NCT00003014|Drug|carboplatin|
16375949|NCT00003014|Radiation|radiation therapy|
16375950|NCT00002930|Procedure|positron emission tomography|
16375951|NCT00002930|Radiation|fludeoxyglucose F 18|
16375952|NCT00002928|Drug|paclitaxel|
16375953|NCT00002919|Biological|filgrastim|
16375954|NCT00002919|Drug|cisplatin|
16375955|NCT00002919|Drug|doxorubicin hydrochloride|
16375956|NCT00002919|Drug|methotrexate|
16375957|NCT00002919|Drug|vinblastine sulfate|
16375958|NCT00002919|Procedure|conventional surgery|
16375959|NCT00002901|Drug|docetaxel|
16375960|NCT00002858|Drug|cisplatin|
16375961|NCT00002858|Drug|cyclophosphamide|
16375962|NCT00002858|Drug|doxorubicin hydrochloride|
16375963|NCT00002858|Drug|etoposide|
16375964|NCT00002858|Radiation|radiation therapy|
16375965|NCT00079612|Drug|Sorafenib (Nexavar, BAY43-9006)|800mg daily (2x 400mg tabs)
16375966|NCT00079612|Drug|Placebo|2x 400mg tabs daily
16375967|NCT00079586|Drug|Heparin|Unfractionated Heparin per institutional practice
16375968|NCT00079586|Drug|Bivalirudin|1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion
16375969|NCT00079508|Drug|Angiomax (bivalirudin)|250 mg vial administered as 1.0 mg/kg intravenous (IV) bolus and 2.5 mg/kg/h IV infusion during the procedure with the option to administer additional 0.1 to 0.5 mg/kg boluses to increase the level of anticoagulation as clinically indicated. A low-dose infusion could have been administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. A starting bolus of 0.1 mg/kg and/or an infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.
16375970|NCT00021359|Drug|dexamethasone|
16375971|NCT00021359|Drug|isotretinoin|
16375972|NCT00017030|Drug|trabectedin|
16375973|NCT00016978|Drug|FOLFOX regimen|
16375974|NCT00016978|Drug|fluorouracil|
16375975|NCT00016978|Drug|leucovorin calcium|
16375976|NCT00016978|Drug|oxaliplatin|
16375977|NCT00014547|Drug|BBR 3464|
16375978|NCT00007969|Biological|Detox-B adjuvant|
16375979|NCT00007969|Drug|verteporfin|
16375980|NCT00002823|Drug|cisplatin|
16375981|NCT00002823|Drug|etoposide|
16375982|NCT00002823|Drug|vinblastine sulfate|
16375983|NCT00002823|Drug|vindesine|
16375984|NCT00002823|Drug|vinorelbine tartrate|
16375985|NCT00002823|Radiation|radiation therapy|
16375986|NCT00002650|Dietary Supplement|folic acid|
16375987|NCT00002601|Biological|filgrastim|5 ug/kg daily following stem cell reinfusion
16375988|NCT00002601|Drug|cisplatin|Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr
16375989|NCT00002601|Drug|doxorubicin hydrochloride|Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours.
16375990|NCT00002601|Drug|ifosfamide|Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours.
16375991|NCT00002601|Drug|melphalan|Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute
16375992|NCT00002601|Procedure|peripheral blood stem cell transplantation|Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2
16375993|NCT00002581|Drug|cyclophosphamide|
16375994|NCT00002581|Drug|fluorouracil|
16375995|NCT00002581|Drug|methotrexate|
16375996|NCT00002581|Drug|tamoxifen citrate|
16375997|NCT00002581|Procedure|conventional surgery|
16375998|NCT00002581|Radiation|radiation therapy|
16375999|NCT00002580|Drug|cyclophosphamide|
16376000|NCT00002580|Drug|fluorouracil|
16376001|NCT00002580|Drug|goserelin acetate|
16376002|NCT00002580|Drug|leuprolide acetate|
16376003|NCT00002580|Drug|methotrexate|
16376004|NCT00002580|Drug|tamoxifen citrate|
16376005|NCT00002580|Procedure|conventional surgery|
16376006|NCT00002580|Procedure|laparoscopic surgery|
16376007|NCT00002580|Procedure|oophorectomy|
16376008|NCT00002580|Radiation|radiation therapy|
16376009|NCT00002537|Drug|topotecan hydrochloride|
16376010|NCT00002537|Radiation|radiation therapy|
16376011|NCT00002526|Biological|filgrastim|
16376012|NCT00002526|Drug|doxorubicin hydrochloride|
16376013|NCT00002526|Drug|ifosfamide|
16376014|NCT00002508|Drug|carboplatin|
16376015|NCT00002508|Drug|etoposide|
16376016|NCT00002508|Procedure|autologous bone marrow transplantation|
16376017|NCT00002508|Procedure|peripheral blood stem cell transplantation|
16376018|NCT00002480|Radiation|radiation therapy|
16376019|NCT00002459|Radiation|radiation therapy|
16376020|NCT00079625|Drug|Th2/Tc2 Cells|
16376021|NCT00079599|Drug|L-carnitine|A study drug, L-carnitine, titrating the doses from 0.5 g to 3 g to reduce the possibility of side effects, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
16376022|NCT00079599|Other|Placebo|A placebo, where patients underwent the dose titration identical to the study patients, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
16376023|NCT00079573|Behavioral|Atkins diet (extremely low carbohydrate)|
16376024|NCT00079573|Behavioral|Zone diet (low carbohydrate, high protein)|
16376025|NCT00079573|Behavioral|Ornish diet (very low fat)|
16376026|NCT00079560|Drug|dronabinol|dronabinol to prevent development of marijuana withdrawal
16376027|NCT00079547|Behavioral|Low-calorie diet|low-calorie diet
16376028|NCT00079547|Behavioral|low-carbohydrate diet|low-carbohydrate diet
16376029|NCT00079534|Behavioral|Non-local/distant healing or prayer|
16376030|NCT00079521|Procedure|Therapeutic Touch|
16376031|NCT00079495|Drug|NBI-5788|
16376032|NCT00079482|Drug|CEP-701|
16376033|NCT00079482|Drug|high-dose cytarabine|Chemotherapy
16376034|NCT00079482|Drug|Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)|Chemotherapy
16376035|NCT00079469|Behavioral|smoking cessation intervention|
16376036|NCT00079469|Drug|bupropion hydrochloride|
16376037|NCT00079456|Drug|temsirolimus|Given IV
16376038|NCT00079456|Other|pharmacological study|Correlative studies
16376039|NCT00079456|Other|laboratory biomarker analysis|Correlative studies
16376040|NCT00079443|Drug|romidepsin|Given IV
16376041|NCT00079443|Biological|rituximab|Given IV
16376042|NCT00079443|Drug|fludarabine phosphate|Given IV
16376497|NCT00003299|Drug|etoposide|
16376043|NCT00079443|Other|laboratory biomarker analysis|Correlative studies
16376044|NCT00079430|Procedure|adjuvant therapy|
16376045|NCT00079430|Drug|paclitaxel|Given IV
16376046|NCT00079430|Drug|carboplatin|Given intraperitoneally
16376047|NCT00079430|Biological|bevacizumab|Given IV
16376048|NCT00079417|Procedure|cryosurgery|Application of extreme cold to destroy abnormal or diseased tissue.
16376049|NCT00079417|Procedure|infrared laser therapy|"Laser therapy or photobiomodulation is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects"
16376050|NCT00079417|Radiation|iodine I 125|Undergo radioactive therapy
16376051|NCT00079417|Radiation|ruthenium Ru 106|Undergo radioactive therapy
16376052|NCT00079417|Drug|carboplatin|Given IV
16376053|NCT00079417|Drug|vincristine sulfate|Given IV
16376054|NCT00079417|Radiation|radiation therapy|Undergo radioactive therapy
16376055|NCT00079404|Drug|tanespimycin|Given IV
16376056|NCT00079391|Device|allogeneic hematopoietic stem cell transplantation|Manipulated Peripheral Blood Stem Cell graft on Day 0. Target CD34+ dose 6 x10e6/kg, (range 3 to 8x10e6/kg) CD3+ dose fixed to 2 x 10e4/kg.
16376057|NCT00079378|Drug|decitabine|Given IV
16376058|NCT00079378|Drug|valproic acid|Given orally
16376059|NCT00079378|Other|pharmacological study|Correlative studies
16376060|NCT00079378|Other|laboratory biomarker analysis|Correlative studies
16376061|NCT00079365|Drug|fluorouracil|
16376062|NCT00079365|Drug|gemcitabine hydrochloride|
16376063|NCT00079365|Radiation|brachytherapy|
16376064|NCT00079365|Radiation|phosphorus P32|
16376065|NCT00079365|Radiation|radiation therapy|
16376066|NCT00079352|Drug|alvocidib|Given IV
16376067|NCT00079352|Drug|gemcitabine hydrochloride|Given IV
16376068|NCT00079352|Drug|irinotecan hydrochloride|Given IV
16376069|NCT00079339|Radiation|radiation therapy|Undergo radiotherapy
16376070|NCT00079339|Drug|tipifarnib|Given orally
16376071|NCT00079326|Biological|trastuzumab|Given IV
16376072|NCT00079326|Drug|ixabepilone|Given IV
16376073|NCT00079326|Other|laboratory biomarker analysis|Correlative studies
16376074|NCT00079313|Drug|Imatinib|
16376075|NCT00079300|Drug|imiquimod|
16376076|NCT00079300|Procedure|conventional surgery|
16376077|NCT00079287|Drug|carboplatin|
16376078|NCT00079287|Drug|docetaxel|
16376079|NCT00079287|Drug|gemcitabine hydrochloride|
16376080|NCT00079287|Drug|paclitaxel|
16376081|NCT00079287|Drug|vinorelbine tartrate|
16376082|NCT00079274|Drug|irinotecan hydrochloride|Given IV
16376083|NCT00079274|Drug|oxaliplatin|Given IV
16376084|NCT00079274|Drug|leucovorin calcium|Given IV
16376085|NCT00079274|Drug|fluorouracil|Given IV
16376086|NCT00079274|Biological|cetuximab|Given IV
16376087|NCT00079274|Drug|Locally Directed Therapy|Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
16376088|NCT00079261|Drug|CHOP regimen|
16376089|NCT00079261|Drug|cyclophosphamide|
16376090|NCT00079261|Drug|doxorubicin hydrochloride|
16376091|NCT00079261|Drug|gemcitabine hydrochloride|
16376092|NCT00079261|Drug|prednisone|
16376093|NCT00079261|Drug|vincristine sulfate|
16376094|NCT00079248|Biological|therapeutic progesterone|
16376095|NCT00079248|Drug|conjugated estrogens|
16376096|NCT00079235|Drug|temsirolimus|Given IV
16376097|NCT00079235|Other|laboratory biomarker analysis|Correlative studies
16376098|NCT00079222|Drug|itraconazole|
16376099|NCT00079222|Drug|voriconazole|
16376100|NCT00079183|Drug|sirolimus|Given PO
16376101|NCT00079170|Dietary Supplement|garlic|
16376102|NCT00079170|Drug|docetaxel|
16376103|NCT00079157|Biological|incomplete Freund's adjuvant|
16376104|NCT00079157|Biological|sargramostim|
16376105|NCT00079157|Biological|telomerase: 540-548 peptide vaccine|
16376106|NCT00079144|Biological|NY-ESO-1 peptide vaccine|
16376107|NCT00079144|Biological|aldesleukin|
16376108|NCT00079144|Biological|filgrastim|
16376109|NCT00079144|Biological|incomplete Freund's adjuvant|
16376110|NCT00079144|Biological|therapeutic autologous lymphocytes|
16376111|NCT00079144|Drug|cyclophosphamide|
16376112|NCT00079144|Drug|fludarabine phosphate|
16376113|NCT00079131|Biological|oblimersen sodium|Given IV
16376114|NCT00079131|Other|pharmacological study|Correlative studies
16376115|NCT00079131|Other|laboratory biomarker analysis|Correlative studies
16376116|NCT00079118|Drug|docetaxel|
16376117|NCT00079118|Drug|irinotecan hydrochloride|
16376118|NCT00079105|Biological|bleomycin sulfate|Treatment
16376119|NCT00079105|Drug|cyclophosphamide|Treatment
16376120|NCT00079105|Drug|etoposide|Treatment
16376121|NCT00079105|Drug|mitoxantrone hydrochloride|Treatment
16376122|NCT00079105|Drug|prednisolone|Treatment
16376123|NCT00079105|Drug|procarbazine hydrochloride|Treatment
16376124|NCT00079105|Drug|vinblastine sulfate|Treatment
16376125|NCT00079092|Drug|procarbazine hydrochloride|
16376126|NCT00079092|Drug|thalidomide|
16376127|NCT00079079|Drug|carboplatin|
16376128|NCT00079079|Drug|cisplatin|
16376129|NCT00079079|Drug|gemcitabine hydrochloride|
16376130|NCT00079066|Biological|cetuximab|
16376131|NCT00079066|Procedure|quality-of-life assessment|
16376132|NCT00079053|Drug|erlotinib hydrochloride|
16376133|NCT00079053|Procedure|adjuvant therapy|
16376134|NCT00079040|Drug|cisplatin|Given IV
16376135|NCT00079040|Drug|etoposide|Given IV
16376136|NCT00079040|Biological|bevacizumab|Given IV
16376137|NCT00079040|Other|laboratory biomarker analysis|Correlative studies
16376138|NCT00079027|Drug|doxorubicin hydrochloride|
16376139|NCT00079027|Procedure|hepatic artery embolization|
16376140|NCT00079014|Drug|triapine|Given IV
16376141|NCT00079014|Drug|doxorubicin hydrochloride|Given IV
16376142|NCT00079014|Other|laboratory biomarker analysis|Correlative studies
16376143|NCT00079014|Other|pharmacological study|Correlative studies
16376144|NCT00079001|Drug|zoledronic acid|Given IV
16376145|NCT00079001|Other|placebo|Given IV
16376146|NCT00079001|Drug|androgen deprivation therapy|Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive androgen deprivation therapy per SWOG-9346. All other patients will receive androgen deprivation therapy at a standard dose and schedule throughout the study.
16376147|NCT00079001|Drug|GnRH agonist|Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive the GnRH agonist per SWOG-9346. All other patients will receive GnRH agonist at a standard dose and schedule throughout the study.
16376148|NCT00079001|Dietary Supplement|Calcium supplement|Patients will receive 500 mg by mouth daily of a calcium supplement or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.
16376149|NCT00079001|Dietary Supplement|Vitamin D|Patients will receive a multivitamin tablet containing 400-500 IU vitamin D by mouth daily or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.
16376150|NCT00078988|Biological|filgrastim|Given IV
16376151|NCT00078988|Drug|carboplatin|Given IV
16376152|NCT00078988|Drug|etoposide|Given IV
16376153|NCT00078988|Drug|isotretinoin|Given IV
16376154|NCT00078988|Drug|thiotepa|Given IV
16376155|NCT00078988|Procedure|autologous bone marrow transplantation|Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
16376156|NCT00078988|Procedure|peripheral blood stem cell transplantation|Filgrastim is to be given daily in the afternoon for 4 days prior to the first harvest and continued until the completion of the daily harvests. The daily PBSC harvesting should be started prior to the fifth dose of filgrastim.
16376157|NCT00078975|Drug|gemcitabine hydrochloride|
16376158|NCT00078975|Drug|triapine|
16376159|NCT00078962|Biological|GTI-2040|Given IV
16376160|NCT00078962|Drug|gemcitabine hydrochloride|Given IV
16376161|NCT00078962|Other|laboratory biomarker analysis|Correlative studies
16376162|NCT00078962|Other|pharmacological study|Correlative studies
16376163|NCT00078949|Biological|rituximab|Given IV
16376164|NCT00078949|Drug|cisplatin|Given IV
16376165|NCT00078949|Drug|cytarabine|Given IV
16376166|NCT00078949|Drug|dexamethasone|Given IV
16376167|NCT00078949|Drug|gemcitabine hydrochloride|Given IV
16376168|NCT00078923|Dietary Supplement|soy isoflavones|
16376169|NCT00078923|Procedure|neoadjuvant therapy|Prostatectomy or Brachytherapy
16376170|NCT00078923|Other|Placebo|Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
16376171|NCT00078910|Drug|exisulind|
16376172|NCT00078910|Procedure|conventional surgery|
16376173|NCT00078910|Procedure|neoadjuvant therapy|
16376174|NCT00078897|Drug|Selenium|Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
16376175|NCT00078858|Drug|fludarabine phosphate|Given IV
16376176|NCT00078858|Radiation|total-body irradiation|Undergo TBI
16376177|NCT00078858|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBMC transplantation
16376178|NCT00078858|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBMC transplantation
16376179|NCT00078858|Drug|cyclosporine|Given PO
16376180|NCT00078858|Drug|mycophenolate mofetil|Given PO or IV
16376181|NCT00078858|Other|laboratory biomarker analysis|Correlative studies
16376182|NCT00078845|Drug|Amifostine|500 mg three times a week.
16376183|NCT00078832|Drug|anastrozole|aromatase inhibitor
16376184|NCT00078832|Drug|placebo|Arimidex placebo
16376185|NCT00078819|Drug|Etanercept|Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week
16376186|NCT00078819|Drug|Placebo|Placebo matching to etanercept administered by subcutaneous injection once a week
16376187|NCT00078806|Drug|Etanercept|Administered by subcutaneous injection twice a week
16376188|NCT00078806|Drug|Placebo|Administered by subcutaneous injection twice a week
16376189|NCT00078793|Drug|Enbrel®|Etanercept alone, etanercept plus methotrexate or other DMARDs
16376190|NCT00078767|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
16376191|NCT00078767|Drug|Sertraline Pill|12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
16376192|NCT00078767|Drug|Placebo Oral Tablet|12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
16376193|NCT00078754|Drug|Fluoxetine|Fluoxetine capsules by mouth, up to 60 mg daily
16376194|NCT00078754|Drug|Divalproex|Divalproex ER capsules by mouth, up to 3000 mg daily
16376195|NCT00078754|Drug|Placebo|Placebo capsules by mouth, up to 8 capsules daily
16376196|NCT00078741|Behavioral|Cognitive Behavioral Therapy (CBT)|
16376197|NCT00078728|Behavioral|Family-Based Anxiety Prevention Program|Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
16376198|NCT00078728|Behavioral|Evaluation only|Participants will undergo evaluations without active treatment for 8 weeks.
16376199|NCT00078611|Drug|natalizumab|
16376200|NCT00007007|Procedure|management of therapy complications|
16376201|NCT00007007|Procedure|quality-of-life assessment|
16376202|NCT00006890|Drug|prednisone|Prednisone 50mg on alternate days
16376203|NCT00006890|Drug|thalidomide|THALIDOMIDE 200 mg qhs
16376204|NCT00006467|Drug|ISIS 2503|
16376205|NCT00006467|Drug|gemcitabine hydrochloride|
16376206|NCT00006452|Drug|motexafin gadolinium|
16376207|NCT00006452|Radiation|radiation therapy|
16376208|NCT00006350|Biological|daclizumab|
16376209|NCT00006350|Biological|therapeutic allogeneic lymphocytes|
16376210|NCT00006350|Drug|mycophenolate mofetil|
16376211|NCT00006350|Drug|tacrolimus|
16376212|NCT00006350|Procedure|peripheral blood stem cell transplantation|
16376213|NCT00006259|Radiation|stereotactic radiosurgery|Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1.
16376214|NCT00006253|Behavioral|Nurse|Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
16376215|NCT00006253|Behavioral|Non-nurse coach|Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management
16376216|NCT00006126|Drug|busulfan|
16376217|NCT00006126|Drug|cyclophosphamide|
16376218|NCT00006126|Drug|etoposide|
16376219|NCT00006126|Drug|fludarabine phosphate|
16376220|NCT00006126|Procedure|peripheral blood stem cell transplantation|
16376221|NCT00006126|Radiation|radiation therapy|
16376222|NCT00006115|Drug|FOLFIRI regimen|
16376223|NCT00006115|Drug|FOLFOX regimen|
16376224|NCT00006115|Drug|fluorouracil|
16376225|NCT00006115|Drug|irinotecan hydrochloride|
16376226|NCT00006115|Drug|leucovorin calcium|
16376227|NCT00006115|Drug|oxaliplatin|
16376228|NCT00006018|Drug|BMS-214662|This is a dose-escalation study of BMS-214662. BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent courses, patients receive BMS-214662 IV over 1 hour on day 1 (30 minutes after paclitaxel). Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
16376229|NCT00006018|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1 of course 1. For all subsequent courses, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
16376230|NCT00078715|Drug|Yohimbine hydrochloride|Participants receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.
16376231|NCT00078715|Drug|Placebo|Participants receive an inactive equivalent of yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.
16376232|NCT00078689|Drug|Daclizumab|
16376233|NCT00078637|Drug|E7820|
16376234|NCT00006000|Drug|cisplatin|
16376235|NCT00006000|Drug|irinotecan hydrochloride|
16376236|NCT00006000|Drug|semaxanib|
16376237|NCT00005965|Drug|bryostatin 1|
16376238|NCT00005965|Drug|cisplatin|
16376239|NCT00005947|Biological|sipuleucel-T|Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
16376240|NCT00005947|Biological|Placebo|Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
16376241|NCT00005946|Biological|filgrastim|
16376242|NCT00005946|Biological|therapeutic allogeneic lymphocytes|
16376243|NCT00005946|Drug|cyclophosphamide|
16376244|NCT00005946|Drug|etoposide|
16376245|NCT00005843|Drug|tipifarnib|
16376246|NCT00078663|Behavioral|Oral Care|
16376247|NCT00078624|Other|Traditional exercise therapy for knee osteoarthritis|Exercises include stretching, strengthening, and aerobic exercise
16376248|NCT00078624|Other|Knee stability training|The addition of agility and perturbation training techniques to the traditional exercise program
16376249|NCT00005595|Drug|arsenic trioxide|
16376250|NCT00005096|Drug|docetaxel|
16376251|NCT00005035|Drug|oxaliplatin|
16376252|NCT00004914|Biological|epoetin alfa|
16376253|NCT00004914|Procedure|physical therapy|
16376254|NCT00078598|Drug|Rituximab or Iodine I 131 Tositumomab Therapy|
16376255|NCT00078585|Biological|PROSTVAC®-VF/TRICOM™|
16376256|NCT00078572|Drug|capecitabine|Capecitabine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the monotherapy arm was 2500 mg/m2 and for the combination arm was 2000 mg/m2.
16376257|NCT00078572|Drug|lapatinib (GW572016)|Lapatinib 1250 mg orally once daily
16376258|NCT00078507|Behavioral|Sensory Re-training|
16376259|NCT00078507|Behavioral|Sensory Retraining|Facial Exercises
16376260|NCT00078507|Behavioral|Opening Exercises|
16376261|NCT00004912|Drug|megestrol acetate|
16376262|NCT00004912|Procedure|physical therapy|
16376263|NCT00004908|Drug|cyclophosphamide|
16376264|NCT00004908|Procedure|peripheral blood stem cell transplantation|
16376265|NCT00004908|Radiation|radiation therapy|
16376266|NCT00004904|Biological|anti-thymocyte globulin|
16376267|NCT00004904|Biological|filgrastim|
16376268|NCT00004904|Drug|cladribine|
16376269|NCT00004904|Drug|cyclophosphamide|
16376270|NCT00004904|Drug|etoposide|
16376271|NCT00004904|Drug|methylprednisolone|
16376272|NCT00004904|Drug|tacrolimus|
16376273|NCT00004904|Procedure|allogeneic bone marrow transplantation|
16376274|NCT00004904|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16376275|NCT00004898|Biological|filgrastim|
16376276|NCT00004898|Drug|cyclophosphamide|
16376277|NCT00004898|Drug|etoposide|
16376278|NCT00004898|Procedure|peripheral blood stem cell transplantation|
16376279|NCT00004898|Radiation|radiation therapy|
16376280|NCT00004235|Drug|docetaxel|
16376281|NCT00004235|Drug|irinotecan hydrochloride|
16376282|NCT00004175|Drug|cyclophosphamide|
16376283|NCT00004175|Drug|docetaxel|
16376284|NCT00004175|Drug|doxorubicin hydrochloride|
16376285|NCT00004175|Procedure|conventional surgery|
16376286|NCT00078559|Drug|Alemtuzumab|30mg intravenous infusion on days 0 (transplant), 1, and 2
16376287|NCT00078559|Drug|Sirolimus|2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
16376288|NCT00078559|Drug|Tacrolimus|2mg orally twice daily, on days 1-60
16376289|NCT00078559|Procedure|Kidney transplant|Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
16376290|NCT00078559|Drug|Methylprednisolone (or equivalent)|250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
16376291|NCT00078559|Drug|Acetaminophen|650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
16376292|NCT00078559|Drug|Diphenhydramine|25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
16376293|NCT00078559|Drug|Trimethoprim (TMP)/Sulfa (Bactrim, Septra)|1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
16376294|NCT00078559|Drug|Valgancyclovir|Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
16376295|NCT00078559|Drug|Acyclovir|400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
16376296|NCT00078559|Drug|Pentamidine|300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
16376297|NCT00078559|Drug|Clotrimazole|10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
16376298|NCT00078559|Drug|Nystatin|500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)
16376299|NCT00078546|Biological|EBV specific CTL Infusion|"One injection at one of the following dose levels
~Dose level I: 2x107/m2 Dose level II: 5x107/m2 Dose level III: 1x108/m2"
16376300|NCT00078546|Biological|Anti CD45 monoclonal antibody|400ug/kg over 6 to 8 hr for 4 days
16376301|NCT00078533|Biological|CMV CTL infusion|Three dose levels will be explored. The lowest dose level will be 1x10^7cells/m2 and the highest will be 1x10^8/m2. 3-6 pts will be entered at each dose level (depending on toxicity). If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. Additional patients will be treated at dose level 1 in order to assess the secondary objective of virus-specific immunity from the CTL infusions
16376302|NCT00078520|Biological|Dose Level 1|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 0
16376303|NCT00078520|Biological|Dose Level 2|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 2 x 10^6
16376304|NCT00078520|Biological|Dose Level 2- Fixed Dose|IL-2-B-CLL 2 x 10^7; CD40L-B-CLL 2 x 10^7
16376305|NCT00078468|Drug|PELITREXOL/AG-2037|
16376306|NCT00078494|Drug|EBV-LMP-2|
16376307|NCT00078481|Drug|Idebenone|
16376308|NCT00078455|Drug|ILX651|
16376309|NCT00078221|Device|Rheopheresis blood filtration|
16376310|NCT00004171|Drug|busulfan|
16376311|NCT00004171|Drug|cyclophosphamide|
16376312|NCT00004171|Procedure|peripheral blood stem cell transplantation|
16376313|NCT00004091|Other|Papanicolaou test|
16376314|NCT00004091|Other|cytology specimen collection procedure|
16376315|NCT00004091|Other|fluorescent antibody technique|
16376316|NCT00004091|Procedure|colposcopic biopsy|
16376317|NCT00004091|Procedure|study of high risk factors|
16376318|NCT00003528|Drug|raltitrexed|Given IV
16376319|NCT00003351|Drug|irinotecan hydrochloride|
16376320|NCT00003302|Procedure|biopsy|
16376321|NCT00003302|Diagnostic Test|magnetic resonance imaging|
16376322|NCT00003302|Diagnostic Test|mammography|
16376323|NCT00003264|Drug|cisplatin|
16376324|NCT00003264|Drug|gemcitabine hydrochloride|
16376325|NCT00003070|Drug|enalapril maleate|
16376326|NCT00003070|Procedure|quality-of-life assessment|
16376327|NCT00003040|Procedure|laser surgery|CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed
16376328|NCT00003040|Radiation|radiation therapy|200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery
16376329|NCT00002825|Biological|filgrastim|
16376330|NCT00002825|Drug|docetaxel|
16376331|NCT00002652|Drug|suramin|
16376332|NCT00026429|Biological|denileukin diftitox|
16376333|NCT00025012|Drug|isotretinoin|
16376334|NCT00024037|Procedure|management of therapy complications|
16376335|NCT00022542|Drug|ixabepilone|Given IV
16376336|NCT00022308|Drug|cisplatin|
16376337|NCT00022308|Drug|irinotecan hydrochloride|
16376338|NCT00022308|Radiation|radiation therapy|
16376339|NCT00022217|Drug|carboplatin|
16376340|NCT00022217|Drug|cisplatin-e therapeutic implant|
16376341|NCT00022217|Drug|paclitaxel|
16376342|NCT00022178|Drug|cisplatin|
16376343|NCT00022178|Drug|cyclophosphamide|
16376344|NCT00022178|Drug|doxorubicin hydrochloride|
16376345|NCT00022178|Drug|epirubicin hydrochloride|
16376346|NCT00022178|Drug|fluorouracil|
16376347|NCT00022178|Drug|vincristine sulfate|
16376348|NCT00021996|Drug|valdecoxib|
16376349|NCT00021372|Drug|estramustine phosphate sodium|
16376350|NCT00021372|Drug|paclitaxel|
16376351|NCT00020618|Drug|morphine sulfate|
16376352|NCT00020618|Procedure|quality-of-life assessment|
16376353|NCT00020098|Procedure|evaluation of cancer risk factors|
16376354|NCT00019409|Drug|asparaginase|
16376355|NCT00019409|Drug|cyclophosphamide|
16376356|NCT00019409|Drug|cytarabine|
16376357|NCT00019409|Drug|daunorubicin hydrochloride|
16376358|NCT00019409|Drug|mercaptopurine|
16376359|NCT00019409|Drug|methotrexate|
16376360|NCT00019409|Drug|prednisone|
16376361|NCT00019409|Drug|therapeutic hydrocortisone|
16376362|NCT00019409|Drug|vincristine sulfate|
16376363|NCT00019409|Radiation|radiation therapy|
16376364|NCT00017303|Drug|carboplatin|
16376365|NCT00017303|Drug|oglufanide disodium|
16376366|NCT00017303|Drug|paclitaxel|
16376367|NCT00017303|Procedure|conventional surgery|
16376368|NCT00016367|Biological|Trastuzumab|"Regimen A: Trastuzumab IV over 90 minutes on days 2 and 8.
~Regimen B: Trastuzumab IV over 30-90 minutes on days 1, 8 and 15."
16376369|NCT00016367|Drug|Cisplatin|"Regimen A: Cisplatin IV over 2 hours on day 1 following gemcitabine.
~Regimen B: Cisplatin IV over 2 hours on day 1."
16376370|NCT00016367|Drug|Gemcitabine Hydrochloride|"Regimen A: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.
~Regimen B: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab."
16376371|NCT00015990|Drug|thalidomide|Given orally
16376372|NCT00015990|Other|laboratory biomarker analysis|Correlative studies
16376373|NCT00015964|Drug|ZD1839|
16376374|NCT00002597|Drug|flutamide|Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.
16376375|NCT00002597|Drug|Zoladex|3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
16376376|NCT00002597|Drug|Lupron|7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
16376377|NCT00002597|Radiation|radiation therapy|46.8 Gy (1.8 Gy/day four to five times a week [26 fx]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.
16376378|NCT00002577|Radiation|radiation therapy|
16376379|NCT00002454|Biological|autologous tumor cell vaccine|
16376380|NCT00078442|Drug|Pegylated interferon alfa-2a|Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment
16376381|NCT00078390|Drug|S-3304|S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
16376382|NCT00078390|Other|Chemo-irradiation|Standard of care chemo-irradiation
16376383|NCT00078377|Drug|Armodafinil|Armodafinil 250 mg once daily in the morning
16376384|NCT00078377|Drug|Armodafinil|Armodafinil 150 mg once daily in the morning
16376385|NCT00078377|Drug|Placebo|Matching placebo tablets once daily
16376386|NCT00078338|Drug|Rebif®|Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
16376387|NCT00078338|Drug|Copaxone®|Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
16376388|NCT00076687|Biological|botulinum toxin Type A|botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
16376389|NCT00076687|Biological|botulinum toxin Type A|botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
16376390|NCT00076687|Drug|saline|Saline injection at Day 1, Week 12, Week 18
16376391|NCT00014690|Drug|plevitrexed|
16376392|NCT00014690|Drug|topotecan hydrochloride|
16376393|NCT00014339|Drug|Wobe-Mugos E|
16376394|NCT00014339|Drug|melphalan|
16376395|NCT00014339|Drug|prednisone|
16376396|NCT00014339|Procedure|quality-of-life assessment|
16376397|NCT00012259|Drug|troxacitabine|
16376398|NCT00010179|Drug|lurtotecan liposome|
16376399|NCT00006472|Drug|carboplatin|Carboplatin AUC 6 days 1 and 22
16376400|NCT00006472|Drug|fluorouracil|5FU 225mg/m2 continuous infusion on days 1-42 during radiation
16376401|NCT00006472|Drug|paclitaxel|taxol
16376402|NCT00006472|Procedure|conventional surgery|
16376403|NCT00006472|Radiation|radiation therapy|The initial fields should be treated AP:PA when possible to a dose of 4500 cGy in 180 cGy fractions
16376404|NCT00006365|Radiation|brachytherapy|
16376405|NCT00006365|Radiation|iodine I 125|
16376406|NCT00006365|Radiation|radiation therapy|
16376407|NCT00006108|Biological|trastuzumab|
16376408|NCT00006108|Drug|capecitabine|
16376409|NCT00006108|Drug|paclitaxel|
16376410|NCT00006037|Drug|fluorouracil|
16376411|NCT00006037|Drug|irinotecan hydrochloride|
16376412|NCT00006037|Drug|oglufanide disodium|
16376413|NCT00006014|Drug|semaxanib|
16376414|NCT00078403|Drug|Peginterferon alfa-2a|180 mcg PEG-IFN subcutaneously
16376415|NCT00078403|Drug|Ribavirin|One tablet or capsule containing ribavirin 200 mg
16376416|NCT00078325|Drug|Armodafinil 250 mg/day|Armodafinil 250 mg once daily in the morning
16376417|NCT00078325|Drug|Armodafinil 150 mg/day|Armodafinil 150 mg once daily in the morning
16376418|NCT00078325|Drug|Placebo|Matching placebo tablets once daily in the morning
16376419|NCT00078312|Drug|CEP-10953 (Armodafinil)|Armodafinil (po) 100 to 250 mg/day up to 12 months
16376420|NCT00005991|Drug|gemcitabine hydrochloride|
16376421|NCT00005991|Drug|pegylated liposomal doxorubicin hydrochloride|
16376422|NCT00005880|Drug|budesonide|
16376423|NCT00005869|Drug|gemcitabine hydrochloride|
16376424|NCT00005869|Drug|rubitecan|
16376425|NCT00005864|Drug|chloroquinoxaline sulfonamide|
16376426|NCT00005593|Drug|carboplatin|Patients receive carboplatin IV continuously over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
16376427|NCT00005593|Drug|fludarabine phosphate|Patients receive fludarabine IV over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
16376490|NCT00003425|Drug|amifostine trihydrate|
16376491|NCT00003425|Drug|cyclophosphamide|
16376492|NCT00003425|Drug|melphalan|
16376493|NCT00003425|Procedure|peripheral blood stem cell transplantation|
16376494|NCT00003411|Drug|motexafin gadolinium|
16376495|NCT00003411|Radiation|radiation therapy|
16376428|NCT00005593|Drug|topotecan hydrochloride|This is a dose escalation study of topotecan. Patients receive topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.
16376429|NCT00005075|Procedure|high-intensity focused ultrasound ablation|
16376430|NCT00005026|Drug|carboplatin|
16376431|NCT00005026|Drug|paclitaxel|
16376432|NCT00005026|Drug|topotecan hydrochloride|
16376433|NCT00004223|Drug|docetaxel|
16376434|NCT00004223|Drug|gemcitabine hydrochloride|
16376435|NCT00004216|Biological|salmonella VNP20009|
16376436|NCT00004216|Drug|cefixime|
16376437|NCT00004216|Drug|ceftriaxone sodium|
16376438|NCT00004216|Drug|ciprofloxacin|
16376439|NCT00004216|Drug|trimethoprim-sulfamethoxazole|
16376440|NCT00004183|Drug|capecitabine|
16376441|NCT00078364|Procedure|MRI|
16376442|NCT00078351|Procedure|High molecular weight hylan (Synvisc) injection|
16376443|NCT00078286|Drug|Sertraline|Dosage ranging from 50 mg to 200 mg once a day
16376444|NCT00078286|Drug|Placebo|Dosage ranging from 50 mg to 200 mg once a day
16376445|NCT00078273|Behavioral|Personalized Feedback Intervention|Sessions lasted for 60-90 minutes and used Motivational Interviewing (MI) to facilitate discussion of feedback from participants' survey responses. Sessions began with open-ended questions about contextual factors associated with participants' gambling, then review of each feedback section: gambling pattern; perceived gambling norms; positive expectancies and negative consequences of gambling; beliefs about control over gambling; and situational self-efficacy to avoid gambling. Participants were encouraged to consider the feedback in light of their personal goals. All participants received a copy of their feedback, a list of skills for limiting gambling and a resource/referral list.
16376446|NCT00078273|Behavioral|Cognitive Behavioral Intervention|Participants completed either six weekly 1-hour sessions or attend four sessions containing the same content. Sessions covered functional analysis and gambling triggers; challenging cognitive distortions, with emphasis on illusions of control; coping with triggers; assertiveness; and relapse prevention. Participants received a pamphlet covering each week's topic (which was reviewed with the participant if a session was missed), as well as homework sheets and gambling diaries. CBI participants were asked to refrain from gambling for the duration of the group to provide an opportunity to practice and develop skills applicable to gambling and other behavior change situations.
16376447|NCT00078260|Drug|pemetrexed|"A: 500 mg/m2, IV, q 21 days until disease progression
~B: 900 mg/m2, IV, q 21 days until disease progression"
16376448|NCT00078247|Drug|Abacavir|300 mg tablet taken orally twice daily
16376449|NCT00078247|Drug|Lamivudine|300 mg tablet taken orally daily
16376450|NCT00078247|Drug|Zidovudine|300 mg tablet taken orally twice daily
16376451|NCT00078247|Drug|Tuberculosis treatment|Tuberculosis treatment
16376452|NCT00078234|Drug|Oblimersen-rituximab-fludarabine|28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab
16376453|NCT00078169|Behavioral|Behavior Therapy|
16376454|NCT00078156|Behavioral|Behavior Therapy|
16376455|NCT00078143|Behavioral|Behavior Therapy|
16376456|NCT00078195|Biological|omalizumab|A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
16376457|NCT00078195|Biological|Placebo omalizumab|The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
16376458|NCT00078195|Biological|Ragweed rush immunotherapy (RIT)|RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
16376459|NCT00078195|Biological|Placebo rush immunotherapy (RIT)|The placebo for rush immunotherapy will contain the diluents and histamine.
16376460|NCT00078195|Biological|Ragweed immunotherapy (IT)|Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
16376461|NCT00078195|Biological|Placebo immunotherapy (IT)|The placebo for immunotherapy will contain the diluents and histamine.
16376462|NCT00078182|Drug|Tenofovir DF|
16376463|NCT00078130|Drug|Buprenorphine/naloxone|
16376464|NCT00078117|Drug|Buprenorphine|
16376465|NCT00078065|Drug|Xcellerated T Cells|
16376466|NCT00004148|Biological|recombinant vaccinia-B7.1 vaccine|
16376467|NCT00003935|Drug|etoposide|
16376468|NCT00003935|Drug|vincristine sulfate|
16376469|NCT00003935|Radiation|radiation therapy|
16376470|NCT00003814|Drug|eflornithine|
16376471|NCT00003766|Drug|O6-benzylguanine|
16376472|NCT00003623|Dietary Supplement|multivitamin|
16376473|NCT00003623|Other|Placebo|
16376474|NCT00003615|Biological|denileukin diftitox|
16376475|NCT00003600|Biological|epoetin alfa|
16376476|NCT00003600|Other|placebo|
16376477|NCT00003573|Biological|filgrastim|
16376478|NCT00003573|Drug|cisplatin|
16376479|NCT00003573|Drug|cyclophosphamide|
16376480|NCT00003573|Drug|etoposide|
16376481|NCT00003573|Drug|vincristine sulfate|
16376482|NCT00003573|Radiation|radiation therapy|
16376483|NCT00003572|Biological|peripheral blood lymphocyte therapy|
16376484|NCT00003572|Drug|mycophenolate mofetil|
16376485|NCT00003572|Drug|tacrolimus|
16376486|NCT00003572|Procedure|allogeneic bone marrow transplantation|
16376487|NCT00003572|Radiation|radiation therapy|
16376488|NCT00003548|Drug|aminocamptothecin colloidal dispersion|
16376489|NCT00003425|Biological|filgrastim|
16376498|NCT00003299|Drug|paclitaxel|
16376499|NCT00003240|Drug|cisplatin|
16376500|NCT00003240|Drug|ifosfamide|
16376501|NCT00003240|Drug|mitomycin C|
16376502|NCT00003240|Drug|vinblastine sulfate|
16376503|NCT00003240|Drug|vindesine|
16376504|NCT00003240|Drug|vinorelbine tartrate|
16376505|NCT00003240|Procedure|conventional surgery|
16376506|NCT00003240|Radiation|radiation therapy|
16376507|NCT00003120|Drug|paclitaxel|135 mg/m2 IV every 28 days
16376508|NCT00078104|Procedure|Extraction of wisdom teeth|
16376509|NCT00078026|Drug|Apomine|
16376510|NCT00030602|Biological|PSA prostate cancer vaccine|
16376511|NCT00030602|Biological|incomplete Freund's adjuvant|
16376512|NCT00003089|Drug|amifostine trihydrate|
16376513|NCT00003089|Drug|carboplatin|
16376514|NCT00003089|Drug|paclitaxel|
16376515|NCT00003089|Radiation|radiation therapy|
16376516|NCT00003046|Biological|Recombinant Interleukin-12|Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses
16376517|NCT00003035|Biological|filgrastim|
16376518|NCT00003035|Drug|doxorubicin hydrochloride|
16376519|NCT00003035|Drug|paclitaxel|
16376520|NCT00003035|Drug|tamoxifen citrate|
16376521|NCT00003035|Procedure|surgical procedure|
16376522|NCT00003035|Radiation|radiation therapy|
16376523|NCT00078013|Drug|MCC-135|
16376524|NCT00078000|Drug|SU011248|
16376525|NCT00077987|Drug|SU011248|
16376526|NCT00077974|Drug|SU011248|50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
16376527|NCT00077961|Drug|CAMPATH (alemtuzumab)|
16376528|NCT00077948|Drug|Enoximone|Enoximone administered orally
16376529|NCT00077948|Drug|Metoprolol succinate|Metoprolol succinate administered orally
16376530|NCT00077948|Drug|Placebo to match enoximone|Placebo to match match enoximone administered orally
16376531|NCT00077948|Drug|Placebo to match metoprolol succinate|Placebo to match metoprolol succinate administered orally
16376532|NCT00077935|Drug|Civamide|Cream 0.075%, TID for 52 weeks
16376533|NCT00077844|Drug|Enoxaparin sodium|
16376534|NCT00077883|Drug|TLK286, cisplatin|TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).
16376535|NCT00077870|Drug|ocrelizumab|
16376536|NCT00077857|Drug|capecitabine (Xeloda®)|825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
16376537|NCT00077857|Drug|docetaxel (Taxotere®)|75 mg/m^2 intravenous on day 1 of each 3 week cycle
16376538|NCT00077831|Behavioral|neurobehavioral development|observational study of infant and child development
16376539|NCT00077818|Drug|Enoxaparin sodium|
16376540|NCT00077805|Drug|Enoxaparin sodium|
16376541|NCT00077792|Drug|Enoxaparin sodium (XRP4563)|
16376542|NCT00077779|Drug|Adalimumab|
16376543|NCT00077766|Drug|Darbepoetin alfa|Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
16376544|NCT00077766|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
16376545|NCT00077753|Drug|enoxaparin sodium|
16376546|NCT00077727|Drug|Extended-release galantamine hydrobromide|
16376547|NCT00077714|Drug|Paliperidone ER|
16376548|NCT00077688|Drug|TOCOSOL Paclitaxel|
16376549|NCT00076973|Drug|montelukast sodium|Duration of Treatment: 6 months
16376550|NCT00076973|Drug|Comparator: placebo|Duration of Treatment: 6 months
16376551|NCT00027924|Drug|busulfan|
16376552|NCT00027924|Drug|cyclosporine|
16376553|NCT00027924|Drug|fludarabine phosphate|
16376554|NCT00027924|Drug|methotrexate|
16376555|NCT00027924|Procedure|peripheral blood stem cell transplantation|
16376556|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
16376557|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
16376558|NCT00023647|Biological|Synchrotope TA2M|Cancer Vaccine, Immunotherapy
16376559|NCT00021294|Drug|eflornithine|
16376560|NCT00021294|Drug|triamcinolone|
16376561|NCT00021034|Drug|chemotherapy|
16376562|NCT00021034|Drug|taurolidine|
16376563|NCT00021021|Biological|anti-FLT-1 ribozyme|
16376564|NCT00020917|Biological|cetuximab|
16376565|NCT00020917|Drug|fluorouracil|
16376566|NCT00020917|Drug|irinotecan hydrochloride|
16376567|NCT00020917|Drug|leucovorin calcium|
16376568|NCT00020553|Procedure|psychosocial assessment and care|
16376569|NCT00017459|Drug|cisplatin|
16376570|NCT00017459|Drug|tirapazamine|
16376571|NCT00017459|Drug|vinorelbine tartrate|
16376572|NCT00017199|Drug|bortezomib|
16376573|NCT00017056|Drug|ixabepilone|
16376574|NCT00016172|Drug|pegylated liposomal doxorubicin hydrochloride|
16376575|NCT00016172|Drug|picoplatin|
16376576|NCT00014625|Drug|indisulam|
16376577|NCT00014430|Biological|trastuzumab|"Trastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.
~The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation-functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably."
16376578|NCT00014430|Drug|vinorelbine ditartrate|Vinorelbine (trade name Navelbine) is an anti-mitotic chemotherapy drug that is given as a treatment for some types of cancer, including breast cancer and non-small cell lung cancer.
16376579|NCT00008281|Drug|FOLFOX regimen|
16376580|NCT00008281|Drug|fluorouracil|
16376581|NCT00008281|Drug|leucovorin calcium|
16376582|NCT00008281|Drug|oxaliplatin|
16376583|NCT00007878|Drug|bortezomib|Given IV
16376584|NCT00007878|Drug|fluorouracil|Given IV
16376585|NCT00007878|Drug|leucovorin calcium|Given IV
16376586|NCT00007878|Other|pharmacological study|Correlative studies
16376587|NCT00007878|Other|laboratory biomarker analysis|Correlative studies
16376588|NCT00006122|Drug|cytarabine|
16376589|NCT00006122|Drug|etoposide|
16376590|NCT00006122|Drug|gemtuzumab ozogamicin|
16376591|NCT00006122|Drug|idarubicin|
16376592|NCT00006122|Drug|mitoxantrone hydrochloride|
16376593|NCT00005795|Drug|arsenic trioxide|
16376594|NCT00005791|Drug|cisplatin|
16376595|NCT00005791|Drug|fluorouracil|
16376596|NCT00005791|Drug|irinotecan hydrochloride|
16376597|NCT00005631|Biological|filgrastim|
16376598|NCT00005631|Biological|rituximab|
16376599|NCT00005631|Drug|carboplatin|
16376600|NCT00005631|Drug|etoposide|
16376601|NCT00005631|Drug|ifosfamide|
16376602|NCT00005609|Biological|rituximab|
16376603|NCT00005089|Biological|rituximab|375 mg/m^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
16376604|NCT00005089|Drug|cyclophosphamide|750 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
16376605|NCT00005089|Drug|doxorubicin hydrochloride|50 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
16376606|NCT00005089|Drug|prednisone|100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
16376607|NCT00005089|Drug|vincristine sulfate|1.4 mg/m^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
16376608|NCT00005089|Radiation|radiation therapy|4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
16376609|NCT00004152|Drug|iodinated contrast dye|
16376610|NCT00004152|Procedure|computed tomography|
16376611|NCT00004152|Procedure|positron emission tomography|
16376612|NCT00004152|Radiation|fludeoxyglucose F 18|
16376613|NCT00004145|Biological|anti-thymocyte globulin|
16376614|NCT00004145|Drug|cyclophosphamide|
16376615|NCT00004145|Drug|fludarabine phosphate|
16376616|NCT00004145|Procedure|peripheral blood stem cell transplantation|
16376617|NCT00004114|Biological|filgrastim|
16376618|NCT00004114|Drug|cyclophosphamide|
16376619|NCT00004114|Drug|cytarabine|
16376620|NCT00004114|Drug|fludarabine phosphate|
16376621|NCT00004114|Procedure|peripheral blood stem cell transplantation|
16376622|NCT00003916|Radiation|radiation therapy|
16376623|NCT00003916|Radiation|stereotactic radiosurgery|
16376624|NCT00003867|Drug|capecitabine|
16376625|NCT00003867|Drug|irinotecan hydrochloride|
16376626|NCT00003632|Biological|filgrastim|
16376627|NCT00003632|Drug|carmustine|
16376628|NCT00003632|Drug|cytarabine|
16376629|NCT00003632|Drug|etoposide|
16376630|NCT00003632|Drug|melphalan|
16376631|NCT00003632|Drug|methotrexate|
16376632|NCT00003632|Procedure|peripheral blood stem cell transplantation|
16376633|NCT00003582|Drug|amifostine trihydrate|
16376634|NCT00003582|Drug|cisplatin|
16376635|NCT00003582|Drug|fluorouracil|
16376636|NCT00003582|Drug|paclitaxel|
16376637|NCT00003582|Procedure|quality-of-life assessment|
16376638|NCT00003582|Radiation|radiation therapy|
16376639|NCT00003545|Drug|nelarabine|
16376640|NCT00003207|Drug|pegylated liposomal doxorubicin hydrochloride|
16376641|NCT00003207|Drug|PSC 833|
16376642|NCT00003150|Biological|rituximab|
16376643|NCT00003150|Drug|CHOP regimen|
16376644|NCT00003150|Drug|cyclophosphamide|
16376645|NCT00003150|Drug|doxorubicin hydrochloride|
16376646|NCT00003150|Drug|prednisone|
16376647|NCT00003150|Drug|vincristine sulfate|
16376648|NCT00003066|Drug|docetaxel|
16376649|NCT00003066|Drug|estramustine phosphate sodium|
16376650|NCT00003062|Drug|temozolomide|
16376651|NCT00003011|Drug|marimastat|10 mg PO BID
16376652|NCT00003011|Drug|Placebo|10 mg PO BID
16376653|NCT00002869|Biological|recombinant interferon alfa|
16376654|NCT00002869|Drug|cytarabine|
16376655|NCT00002869|Drug|hydroxyurea|
16376656|NCT00002868|Biological|filgrastim|
16376657|NCT00002868|Biological|recombinant interferon alfa|
16376658|NCT00002868|Drug|busulfan|
16376659|NCT00002868|Drug|cytarabine|
16376660|NCT00002868|Drug|etoposide|
16376661|NCT00002868|Drug|hydroxyurea|
16376662|NCT00002868|Drug|idarubicin|
16376663|NCT00002868|Procedure|peripheral blood stem cell transplantation|
16376664|NCT00002532|Biological|filgrastim|
16376665|NCT00002532|Drug|asparaginase|
16376666|NCT00002532|Drug|cytarabine|
16376667|NCT00002532|Drug|daunorubicin hydrochloride|
16376668|NCT00002532|Drug|dexamethasone|
16376669|NCT00002532|Drug|etoposide|
16376670|NCT00002532|Drug|idarubicin|
16376671|NCT00002532|Drug|ifosfamide|
16376672|NCT00002532|Drug|leucovorin calcium|
16376673|NCT00002532|Drug|methotrexate|
16376674|NCT00002532|Drug|prednisolone|
16376675|NCT00002532|Drug|vindesine|
16376676|NCT00002531|Drug|asparaginase|
16376677|NCT00002531|Drug|cyclophosphamide|
16376678|NCT00002531|Drug|cytarabine|
16376679|NCT00002531|Drug|daunorubicin hydrochloride|
16376680|NCT00002531|Drug|dexamethasone|
16376681|NCT00002531|Drug|doxorubicin hydrochloride|
16376682|NCT00002531|Drug|etoposide|
16376683|NCT00002531|Drug|ifosfamide|
16376684|NCT00002531|Drug|leucovorin calcium|
16376685|NCT00002531|Drug|mercaptopurine|
16376686|NCT00002531|Drug|methotrexate|
16376687|NCT00002531|Drug|mitoxantrone hydrochloride|
16376688|NCT00002531|Drug|prednisolone|
16376689|NCT00002531|Drug|teniposide|
16376690|NCT00002531|Drug|thioguanine|
16376691|NCT00002531|Drug|vincristine sulfate|
16376692|NCT00002531|Drug|vindesine|
16376693|NCT00002531|Procedure|allogeneic bone marrow transplantation|
16376694|NCT00002531|Procedure|peripheral blood stem cell transplantation|
16376695|NCT00002531|Radiation|radiation therapy|
16376696|NCT00077922|Drug|LMB-2|40 micrograms/kg every other day (QOD) x 3 every 4 weeks
16376697|NCT00077896|Procedure|Direct Current Polarization|
16376698|NCT00077675|Drug|Telavancin|Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
16376699|NCT00077675|Drug|vancomycin or antistaphylococcal penicillin|Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
16376700|NCT00077649|Drug|ribavirin [Copegus]|600mg po bid for 48 weeks
16376701|NCT00077649|Drug|ribavirin [Copegus]|800mg po bid for 48 weeks
16376702|NCT00077649|Drug|peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]|180 micrograms sc weekly for 48 weeks
16376703|NCT00077649|Drug|peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]|270 micrograms sc weekly for 48 weeks
16376704|NCT00077636|Drug|Copegus|400mg po bid for 16 weeks
16376705|NCT00077636|Drug|Copegus|400mg po bid for 24 weeks
16376706|NCT00077636|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 16 weeks
16376707|NCT00077636|Drug|peginterferon alfa-2a [Pegasys]|180 micrograms sc weekly for 24 weeks
16376708|NCT00077623|Drug|epoetin alfa or beta|iv 3 times weekly, as prescribed
16376709|NCT00077623|Drug|methoxy polyethylene glycol-epoetin beta (Mircera)|60, 100 or 180 micrograms sc (starting dose) every 2 weeks
16376710|NCT00077623|Drug|methoxy polyethylene glycol-epoetin beta (Mircera)|60, 100 or 180 micrograms sc (starting dose) every 4 weeks
16376711|NCT00077610|Drug|Epoetin alfa or beta|intravenously 3 times weekly for 52 weeks, as prescribed
16376712|NCT00077610|Drug|RO0503821 (1x/2 Weeks)|60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
16376713|NCT00077610|Drug|RO0503821 (1x/4 Weeks)|120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
16376714|NCT00077597|Drug|epoetin|3 times a week iv, as prescribed.
16376715|NCT00077597|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|0.4 micrograms/kg iv (starting dose) once every 2 weeks
16376716|NCT00077558|Drug|fludarabine phosphate|
16376717|NCT00077558|Drug|triapine|
16376718|NCT00077545|Drug|triapine|Given IV
16376719|NCT00077545|Drug|cisplatin|Given IV
16376720|NCT00077532|Biological|gp100 antigen|
16376721|NCT00077532|Biological|incomplete Freund's adjuvant|
16376722|NCT00077532|Biological|ipilimumab|
16376723|NCT00077519|Drug|tipifarnib|
16376724|NCT00077519|Radiation|radiation therapy|
16376725|NCT00077493|Drug|BL22 immunotoxin|BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.
16376726|NCT00077493|Procedure|antibody-drug conjugate therapy|CD22 antibody, RFB4 on day 7
16376727|NCT00077493|Procedure|immunotoxin therapy|tested for immunogenicity to CAT-8015 before each cycle and at end of study.
16376728|NCT00077493|Procedure|monoclonal antibody therapy|administered intravenously over 30 minutes.
16376729|NCT00077467|Drug|bortezomib|Given IV
16376730|NCT00077467|Other|pharmacological study|Correlative studies
16376731|NCT00077467|Other|laboratory biomarker analysis|Correlative studies
16376732|NCT00077454|Drug|erlotinib hydrochloride|Given orally (PO)
16376733|NCT00077454|Drug|temozolomide|Given PO
16376734|NCT00077454|Other|pharmacological study|Correlative studies
16376735|NCT00077454|Other|laboratory biomarker analysis|Correlative studies
16376736|NCT00077441|Drug|bortezomib|Given IV
16376737|NCT00077441|Other|laboratory biomarker analysis|Correlative studies
16376738|NCT00077428|Drug|bortezomib|Given IV
16376739|NCT00077428|Drug|doxorubicin hydrochloride|Given IV
16376740|NCT00077428|Other|laboratory biomarker analysis|Correlative studies
16376741|NCT00077415|Drug|gemcitabine hydrochloride|
16376742|NCT00077415|Drug|triapine|
16376743|NCT00077402|Drug|fenretinide|
16376744|NCT00077389|Drug|carboplatin|
16376745|NCT00077389|Drug|cisplatin|
16376746|NCT00077389|Drug|doxorubicin hydrochloride|
16376747|NCT00077389|Procedure|adjuvant therapy|
16376748|NCT00077389|Procedure|conventional surgery|
16376749|NCT00077389|Procedure|neoadjuvant therapy|
16376750|NCT00077376|Biological|trastuzumab|Given IV
16376751|NCT00077376|Drug|ixabepilone|Given IV
16376752|NCT00077376|Drug|carboplatin|Given IV
16376753|NCT00077376|Other|laboratory biomarker analysis|Correlative studies
16376754|NCT00077363|Drug|tipifarnib|Given PO
16376755|NCT00077363|Drug|capecitabine|Given PO
16376756|NCT00077350|Drug|triapine|Given IV
16376757|NCT00077350|Drug|gemcitabine hydrochloride|Given IV
16376758|NCT00077350|Other|laboratory biomarker analysis|Correlative studies
16376759|NCT00077337|Drug|romidepsin|
16376760|NCT00077324|Genetic|proteomic profiling|
16376761|NCT00077324|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
16376762|NCT00077324|Procedure|biopsy|
16376763|NCT00077324|Procedure|surgery|
16376764|NCT00077311|Biological|darbepoetin alfa|200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
16376765|NCT00077311|Biological|pegfilgrastim|6 mg sub Q day 2 of each cycle
16376766|NCT00077311|Drug|cisplatin|75 mg/sq m IV over 1 hr Day 1 of each cycle
16376767|NCT00077311|Drug|docetaxel|75 mg/sq m IV over 1 hr Day 1 of each cycle
16376768|NCT00077311|Drug|BNP7787|40 g IV over 30 min Day 1 of each cycle
16376864|NCT00077129|Drug|paclitaxel|
16376865|NCT00077116|Drug|busulfan|
16376769|NCT00007852|Biological|rituximab|Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
16376770|NCT00007852|Drug|carmustine|BCNU 300 mg/M2 IV day -6
16376771|NCT00007852|Drug|cytarabine|100 mg/m2 on days -5 through -2
16376772|NCT00007852|Drug|etoposide|100mg/M2 BID on days -5 through -2
16376773|NCT00007852|Drug|melphalan|140 mg/m2 IV on day -1
16376774|NCT00007852|Procedure|autologous hematopoietic stem cell transplantation|Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
16376775|NCT00006786|Biological|bevacizumab|
16376776|NCT00006786|Drug|fluorouracil|
16376777|NCT00006786|Drug|irinotecan hydrochloride|
16376778|NCT00006786|Drug|leucovorin calcium|
16376779|NCT00006459|Drug|gemcitabine hydrochloride|
16376780|NCT00006459|Drug|paclitaxel|
16376781|NCT00006388|Drug|tamoxifen citrate|
16376782|NCT00006388|Radiation|radiation therapy|
16376783|NCT00006375|Drug|LY293111|
16376784|NCT00006123|Biological|trastuzumab|
16376785|NCT00006123|Drug|carboplatin|
16376786|NCT00006123|Drug|carmustine|
16376787|NCT00006123|Drug|cisplatin|
16376788|NCT00006123|Drug|cyclophosphamide|
16376789|NCT00006123|Drug|thiotepa|
16376790|NCT00006123|Procedure|peripheral blood stem cell transplantation|
16376791|NCT00006047|Drug|Oral Etoposide|
16376792|NCT00006047|Drug|Oral 9-Nitrocamptothecin|
16376793|NCT00006038|Drug|cisplatin|
16376794|NCT00006038|Drug|docetaxel|
16376795|NCT00006038|Drug|floxuridine|
16376796|NCT00006038|Drug|fluorouracil|
16376797|NCT00006038|Drug|leucovorin calcium|
16376798|NCT00006038|Procedure|conventional surgery|
16376799|NCT00005995|Drug|shark cartilage extract AE-941|
16376800|NCT00005986|Drug|busulfan|
16376801|NCT00005986|Drug|cyclophosphamide|
16376802|NCT00005986|Drug|filgrastim|
16376803|NCT00005986|Drug|recombinant interferon alfa|
16376804|NCT00005986|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16376805|NCT00005986|Procedure|peripheral blood stem cell transplantation|
16376806|NCT00005986|Procedure|radiation therapy|
16376807|NCT00005877|Drug|rubitecan|
16376808|NCT00005862|Drug|semaxanib|
16376809|NCT00005610|Biological|sargramostim|
16376810|NCT00004919|Drug|cisplatin|Given IV
16376811|NCT00004919|Drug|irinotecan hydrochloride|Given IV
16376812|NCT00004919|Drug|amifostine trihydrate|Given IV
16376813|NCT00004919|Other|pharmacological study|Correlative studies
16376814|NCT00004889|Biological|rituximab|375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.
16376815|NCT00004203|Drug|oxaliplatin|
16376816|NCT00004157|Biological|filgrastim|
16376817|NCT00004157|Biological|recombinant interleukin-11|
16376818|NCT00004003|Drug|cisplatin|
16376819|NCT00004003|Drug|fluorouracil|
16376820|NCT00004003|Drug|gemcitabine hydrochloride|
16376821|NCT00077584|Drug|Bosentan 62.5 mg|Oral tablets containing 62.5 mg of bosentan
16376822|NCT00077584|Drug|Bosentan 125 mg|Oral tablets containing 125 mg of bosentan
16376823|NCT00077584|Drug|Placebo|Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets
16376824|NCT00077298|Biological|cetuximab|Given IV
16376825|NCT00077298|Biological|bevacizumab|Given IV
16376826|NCT00077298|Drug|irinotecan hydrochloride|Given IV
16376827|NCT00077298|Other|laboratory biomarker analysis|Correlative studies
16376828|NCT00077285|Biological|filgrastim|
16376829|NCT00077285|Drug|carboplatin|
16376830|NCT00077285|Drug|cyclophosphamide|
16376831|NCT00077285|Drug|dexrazoxane hydrochloride|
16376832|NCT00077285|Drug|doxorubicin hydrochloride|
16376833|NCT00077285|Drug|etoposide|
16376834|NCT00077285|Drug|ifosfamide|
16376835|NCT00077285|Drug|irinotecan hydrochloride|
16376836|NCT00077285|Drug|vincristine sulfate|
16376837|NCT00077285|Procedure|conventional surgery|
16376838|NCT00077285|Radiation|radiation therapy|
16376839|NCT00077259|Drug|epothilone D|
16376840|NCT00077246|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16376841|NCT00077233|Drug|cetuximab|IV
16376842|NCT00077233|Drug|5-FU|IV
16376843|NCT00077233|Drug|irinotecan|IV
16376844|NCT00077233|Drug|leucovorin|IV
16376845|NCT00077233|Drug|oxaliplatin|IV
16376846|NCT00077220|Drug|carboplatin|
16376847|NCT00077220|Drug|paclitaxel|
16376848|NCT00077220|Procedure|adjuvant therapy|
16376849|NCT00077220|Radiation|radiation therapy|
16376850|NCT00077207|Drug|carboplatin|Given IV
16376851|NCT00077207|Drug|temozolomide|Given orally
16376852|NCT00077207|Drug|vincristine sulfate|Given IV
16376853|NCT00077194|Drug|romidepsin|
16376854|NCT00077181|Drug|cytarabine|Given IV
16376855|NCT00077181|Drug|triapine|Given IV
16376856|NCT00077181|Other|laboratory biomarker analysis|Correlative studies
16376857|NCT00077168|Drug|anastrozole|
16376858|NCT00077168|Drug|tamoxifen citrate|
16376859|NCT00077168|Procedure|adjuvant therapy|
16376860|NCT00077168|Radiation|radiation therapy|
16376861|NCT00077155|Drug|cilengitide|
16376862|NCT00077142|Drug|TAC-101|Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
16376863|NCT00077129|Drug|carboplatin|
16376866|NCT00077116|Drug|cyclophosphamide|
16376867|NCT00077116|Drug|cytarabine|
16376868|NCT00077116|Drug|gemtuzumab ozogamicin|
16376869|NCT00077116|Drug|idarubicin|
16376870|NCT00077116|Procedure|allogeneic bone marrow transplantation|
16376871|NCT00077116|Procedure|peripheral blood stem cell transplantation|
16376872|NCT00077116|Radiation|radiation therapy|
16376873|NCT00077103|Biological|filgrastim|filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.
16376874|NCT00077103|Biological|pegfilgrastim|filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.
16376875|NCT00077103|Drug|cisplatin|cisplatin IV over 30-60 minutes on day 1
16376876|NCT00077103|Drug|doxorubicin hydrochloride|doxorubicin IV over 5-10 minutes
16376877|NCT00077103|Drug|fosbretabulin disodium|Combined Modality Phase:Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy. Beginning 4-6 weeks after the completion of the combined modality phase, patients receive CA4P IV over 10 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses.
16376878|NCT00077103|Radiation|radiation therapy|Beginning on day 22, patients undergo radiotherapy twice daily, 5 days a week, for 3-4 weeks.
16376879|NCT00077090|Drug|hyperbaric oxygen|
16376880|NCT00077077|Drug|DJ-927|
16376881|NCT00077077|Drug|capecitabine|
16376882|NCT00077064|Drug|captopril|Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).
16376883|NCT00077051|Drug|cisplatin|
16376884|NCT00077051|Drug|cytochlor|
16376885|NCT00077051|Drug|tetrahydrouridine|
16376886|NCT00077051|Radiation|radiation therapy|
16376887|NCT00077025|Drug|Gefitinib|ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
16376888|NCT00077025|Drug|Anastrozole|1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
16376889|NCT00077012|Drug|QLT0074|
16376890|NCT00077012|Drug|Photodynamic therapy|
16376891|NCT00076999|Drug|TPV oral solution|Tipranavir oral solution
16376892|NCT00076999|Drug|TPV oral solution|Tipranavir oral solution
16376893|NCT00076999|Drug|RTV oral solution|Ritonavir oral solution
16376894|NCT00076999|Drug|RTV oral solution|Ritonavir oral solution
16376895|NCT00076986|Drug|IL13-PE38QQR|
16376896|NCT00076986|Procedure|surgery and catheter placement (2 procedures)|
16376897|NCT00076986|Drug|prolifespan 20 with carmustine implant (GLIADEL® Wafer)|
16376898|NCT00076986|Procedure|surgery and wafer placement (1 procedure)|
16376899|NCT00076960|Drug|Stanate (TM) [stannsoporfin, tin-mesoporphyrin]|Treatment with 4.5 mg/kg
16376900|NCT00076947|Biological|EnvPro|
16376901|NCT00076934|Drug|RG2077 (CTLA4-IgG4m)|RG2077
16376902|NCT00003937|Drug|cisplatin|
16376903|NCT00003937|Drug|dexrazoxane hydrochloride|
16376904|NCT00003937|Drug|doxorubicin hydrochloride|
16376905|NCT00003937|Drug|etoposide|
16376906|NCT00003937|Drug|ifosfamide|
16376907|NCT00003937|Drug|methotrexate|
16376908|NCT00003937|Procedure|conventional surgery|
16376909|NCT00003923|Drug|porfimer sodium|
16376910|NCT00003721|Drug|incyclinide|This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment continues in the absence of disease progression and unacceptable toxic effects. Cohorts of 3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity (DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.
16376911|NCT00003665|Biological|dendritic cell-MART-1 peptide vaccine|
16376912|NCT00003665|Biological|gp100 antigen|
16376913|NCT00003665|Biological|therapeutic tumor infiltrating lymphocytes|
16376914|NCT00003665|Biological|tyrosinase peptide|
16376915|NCT00003616|Drug|irinotecan hydrochloride|
16376916|NCT00003370|Drug|irofulven|
16376917|NCT00003367|Dietary Supplement|green tea|
16376918|NCT00003367|Dietary Supplement|soy protein isolate|
16376919|NCT00003367|Dietary Supplement|vitamin E|
16376920|NCT00003334|Drug|paclitaxel|
16376921|NCT00003334|Drug|pegylated liposomal doxorubicin hydrochloride|
16376922|NCT00003222|Biological|aldesleukin|Systemic subcutaneous delivery of low-dose IL-2.
16376923|NCT00003222|Biological|gp100 antigen|
16376924|NCT00003222|Biological|incomplete Freund's adjuvant|
16376925|NCT00003222|Biological|sargramostim|
16376926|NCT00003222|Biological|tetanus peptide melanoma vaccine|
16376927|NCT00003222|Biological|tyrosinase peptide|
16376928|NCT00003185|Biological|autologous tumor cell vaccine|
16376929|NCT00003185|Biological|sargramostim|
16376930|NCT00003185|Biological|tumor-draining lymph node lymphocyte therapy|
16376931|NCT00003185|Drug|cyclophosphamide|
16376932|NCT00003185|Procedure|conventional surgery|
16376933|NCT00003108|Drug|bryostatin 1|
16376934|NCT00003108|Drug|cisplatin|
16376935|NCT00003086|Biological|filgrastim|
16376936|NCT00003086|Drug|CAF regimen|
16376937|NCT00003086|Drug|carboplatin|
16376938|NCT00003086|Drug|cisplatin|
16376939|NCT00003086|Drug|cyclophosphamide|
16376940|NCT00003086|Drug|doxorubicin hydrochloride|
16376941|NCT00003086|Drug|fluorouracil|
16376942|NCT00003086|Drug|ifosfamide|
16376943|NCT00003086|Drug|melphalan|
16376944|NCT00003086|Drug|paclitaxel|
16376945|NCT00003086|Drug|thiotepa|
16376946|NCT00003086|Procedure|peripheral blood stem cell transplantation|
16376947|NCT00003086|Radiation|samarium Sm 153 lexidronam pentasodium|
16376948|NCT00076869|Drug|MK0991, caspofungin acetate|
16376949|NCT00076869|Drug|Comparator: amphotericin B|
16376950|NCT00076869|Drug|Comparator: lipid formulation of amphotericin B and/or azole|
16376951|NCT00076856|Drug|Temozolomide|
16376952|NCT00076817|Biological|ALVAC-HIV (vCP205)|Canarypox virus vector vaccine
16376953|NCT00076817|Biological|ALVAC-HIV (vCP205)|Canarypox virus vector vaccine placbo
16376954|NCT00076804|Behavioral|Directly Observed Therapy|Use of a patient nominated peer supporter who will observe the morning dose of ARVs
16376955|NCT00076791|Drug|Emtricitabine/Tenofovir disoproxil fumarate|900 mg of TDF combined with 600 mg emtricitabine
16376956|NCT00076791|Drug|Tenofovir disoproxil fumarate|600 mg oral dose of TDF
16376957|NCT00033592|Other|placebo|
16376958|NCT00033592|Drug|bupropion hydrochloride|
16376959|NCT00033592|Drug|nicotine|
16376960|NCT00026377|Drug|bicalutamide|50 mg daily for 1 month
16376961|NCT00026377|Drug|flutamide|250 mg 3 times daily for 1 month
16376962|NCT00026377|Drug|goserelin acetate|3.6 mg once a month for 4 months
16376963|NCT00026377|Drug|leuprolide acetate|7.5 mg once a month for 4 months
16376964|NCT00026377|Drug|SU5416|IV infusion at assigned dose
16376965|NCT00026377|Radiation|radiation therapy|daily for 5 days each week
16376966|NCT00024362|Drug|BBR 3464|
16376967|NCT00024011|Drug|bortezomib|Given IV
16376968|NCT00024011|Other|laboratory biomarker analysis|Correlative studies
16376969|NCT00003320|Procedure|surgical procedure|
16376970|NCT00003320|Radiation|radiation therapy|
16376971|NCT00003320|Radiation|stereotactic radiosurgery|
16376972|NCT00003073|Drug|liposomal cytarabine|
16376973|NCT00002801|Drug|leucovorin calcium|
16376974|NCT00002801|Drug|tegafur-uracil|
16376975|NCT00002801|Radiation|radiation therapy|
16376976|NCT00002679|Biological|filgrastim|
16376977|NCT00002679|Drug|cyclophosphamide|
16376978|NCT00002679|Drug|doxorubicin hydrochloride|
16376979|NCT00002679|Drug|paclitaxel|
16376980|NCT00002679|Drug|tamoxifen citrate|
16376981|NCT00002679|Radiation|radiation therapy|
16376982|NCT00076843|Drug|Hu MiK-Beta-1|
16376983|NCT00076726|Drug|Infliximab|
16376984|NCT00076544|Drug|Ziconotide|
16376985|NCT00076518|Drug|Fenofibrate|
16376986|NCT00076518|Drug|Fish Oil|
16376987|NCT00022373|Drug|iseganan HCl oral solution|
16376988|NCT00022373|Procedure|management of therapy complications|
16376989|NCT00022243|Drug|batabulin sodium|
16376990|NCT00022204|Dietary Supplement|vitamin E|
16376991|NCT00022204|Drug|pentoxifylline|
16376992|NCT00022204|Procedure|quality-of-life assessment|
16376993|NCT00021385|Drug|carboplatin|
16376994|NCT00021385|Drug|squalamine lactate|
16376995|NCT00020696|Drug|cisplatin|
16376996|NCT00020696|Drug|tirapazamine|
16376997|NCT00017407|Biological|ISIS 3521|
16376998|NCT00017407|Drug|carboplatin|
16376999|NCT00017407|Drug|paclitaxel|
16377000|NCT00014105|Drug|carboplatin|
16377001|NCT00014105|Drug|temozolomide|
16377002|NCT00014066|Drug|hematoporphyrin derivative|
16377003|NCT00014066|Radiation|brachytherapy|
16377004|NCT00010244|Radiation|radiation therapy|
16377005|NCT00076752|Drug|fludarabine phosphate|Conditioning and transplant regimen: 30 mg/m^2 day intravenous infusion over 30 minutes daily, 4 days (transplant days -6, -5, -4, -3)
16377006|NCT00076752|Drug|cyclophosphamide|Priming regimen: 2000 mg/m^2 intravenous infusion over 2 hours, day 2. Conditioning and transplant regimen: 1200 mg/m^2 day intravenous infusion daily, 4 days (-6, -5, -4, -3).
16377007|NCT00076752|Biological|Rituxan (rituximab)|Priming regimen: 375 mg/m^2 intravenous day 1, 4. Conditioning and transplant regimen: 750 mg/m^2 intravenous infusion, day -7.
16377008|NCT00076752|Biological|filgrastim|Priming regimen: 10 micrograms/kg/day subcutaneous, starting day 6. Conditioning and transplant regimen: 5 micrograms/kg/day subcutaneous, day +1 until ANC >500 microliters.
16377009|NCT00076752|Drug|methylprednisolone|Priming regimen:1000 mg intravenous over 30 minutes, day 1.
16377010|NCT00076752|Other|immunologic technique|Lymphoablative regimen using cyclophosphamide, rituximab, and fludarabine followed by a CD34 cell selected autologous stem cell transplant.
16377011|NCT00076752|Other|laboratory biomarker analysis|Standard human immunology research laboratory ex vivo studies.
16377012|NCT00076752|Procedure|autologous hematopoietic stem cell transplantation|Day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.
16377013|NCT00076752|Drug|Diphenhydramine|Conditioning and transplant regimen 25-50 mg orally or intravenously.
16377014|NCT00076752|Drug|Mesna|Priming regimen: 600 mg/m^2 intravenous immediately prior to cyclophosphamide and repeat at 4 and 7 hours after the first dose, day 2. Conditioning and transplant regimen:1200 mg/m^2 per day continuous 24 hour intravenous infusion, daily for 4 days, start concurrently with the start of cyclophosphamide.
16377015|NCT00009997|Biological|trastuzumab|
16377016|NCT00009997|Drug|cyclophosphamide|
16377017|NCT00009997|Drug|doxorubicin hydrochloride|
16377018|NCT00009997|Drug|paclitaxel|
16377019|NCT00009997|Drug|tamoxifen citrate|
16377020|NCT00009997|Procedure|conventional surgery|
16377021|NCT00009958|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given SC
16377022|NCT00009958|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|Given intradermally
16377023|NCT00009958|Biological|sargramostim|Given SC
16377024|NCT00009958|Other|laboratory biomarker analysis|Correlative studies
16377025|NCT00009906|Drug|Imatinib Mesylate|Given orally
16377026|NCT00008333|Drug|vinorelbine tartrate|
16377027|NCT00008034|Drug|capecitabine|
16377028|NCT00008034|Drug|cyclophosphamide|
16377029|NCT00008034|Drug|epirubicin hydrochloride|
16377030|NCT00006460|Drug|hyperbaric oxygen|
16377031|NCT00006460|Radiation|radiation therapy|
16377032|NCT00006454|Drug|carboplatin|
16377033|NCT00006454|Drug|paclitaxel|
16377034|NCT00006454|Drug|topotecan hydrochloride|
16377035|NCT00006111|Drug|cisplatin|
16377036|NCT00006111|Drug|fluorouracil|
16377037|NCT00006111|Procedure|conventional surgery|
16377038|NCT00006111|Radiation|radiation therapy|
16377039|NCT00006050|Drug|FOLFOX regimen|
16377040|NCT00006050|Drug|fluorouracil|
16377041|NCT00006050|Drug|isolated perfusion|
16377042|NCT00006050|Drug|leucovorin calcium|
16377043|NCT00006050|Drug|oxaliplatin|
16377044|NCT00005881|Other|Quality of Life Forms|Completion of the instrument [Minneapolis-Manchester Quality of Life (MM-QOL)] that measures HRQOL in the survivors of childhood cancer in a standardized, valid way and to assess the feasibility of incorporating this endpoint in a variety of clinical trials.
16377045|NCT00005792|Drug|etoposide phosphate|Etoposide phosphate 1363 mg/m^2/day IV over 4 hours (total dose 2726 mg/m^2, or 2400 mg/m^2 etoposide equivalents), beginning 24 hours after the completion of the last infusion of topotecan Days -4, -3
16377046|NCT00005792|Drug|melphalan|Melphalan 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2), followed immediately by topotecan. Days -7, -6, -5
16377047|NCT00005792|Drug|topotecan|Topotecan 3.3 mg/m^2/day (starting total dose = 10 mg/m^2 for level 2) IV over 30 minutes. No topotecan will be administered on the first dose level Days -7, -6, -5
16377048|NCT00005792|Procedure|Autologous Stem Cell Rescue|reinfusion of stem cells, Day 0
16377049|NCT00005064|Drug|bortezomib|Given IV
16377050|NCT00076648|Drug|Poly SFH-P Injection|
16377051|NCT00076635|Drug|Interferon gamma-1b|200 mcg, SQ, 3x per week
16377052|NCT00076674|Drug|Intravenous Levodopa|
16377053|NCT00076622|Drug|Antidepressant medication|Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
16377054|NCT00076622|Drug|No antidepressant medication|Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
16377055|NCT00005022|Drug|cisplatin|
16377056|NCT00005022|Drug|etoposide|
16377057|NCT00005022|Radiation|radiation therapy|
16377058|NCT00004862|Biological|filgrastim|
16377059|NCT00004862|Biological|oblimersen sodium|
16377060|NCT00004862|Drug|cytarabine|
16377061|NCT00004862|Drug|fludarabine phosphate|
16377062|NCT00004239|Drug|Compound 506U78|
16377063|NCT00003888|Drug|cisplatin|
16377064|NCT00003888|Drug|docetaxel|
16377065|NCT00003888|Drug|fluorouracil|
16377066|NCT00003888|Radiation|radiation therapy|
16377067|NCT00076609|Drug|PHY906|
16377068|NCT00076609|Drug|capecitabine|
16377069|NCT00076557|Genetic|Adeno-Associated Viral with Human Factor IX|
16377070|NCT00076570|Drug|Sirolimus|
16377071|NCT00076570|Drug|Tacrolimus|
16377072|NCT00076531|Drug|Leuprolide Acetate for Injectable Suspension 22.5 mg|
16377073|NCT00076492|Drug|CoQ10|
16377074|NCT00076492|Drug|GPI 1485|
16377075|NCT00003882|Drug|anhydrovinblastine|
16377076|NCT00003852|Biological|filgrastim|
16377077|NCT00003852|Drug|carboplatin|
16377078|NCT00003852|Drug|cyclophosphamide|
16377079|NCT00003852|Drug|epirubicin hydrochloride|
16377080|NCT00003852|Drug|etoposide|
16377081|NCT00003852|Drug|ifosfamide|
16377082|NCT00003852|Drug|paclitaxel|
16377083|NCT00003852|Drug|thiotepa|
16377084|NCT00003852|Procedure|bone marrow ablation with stem cell support|
16377085|NCT00003852|Procedure|peripheral blood stem cell transplantation|
16377086|NCT00003683|Drug|doxorubicin hydrochloride|
16377087|NCT00003683|Drug|ifosfamide|
16377088|NCT00003682|Drug|doxorubicin hydrochloride|
16377089|NCT00003682|Drug|methylprednisolone|
16377090|NCT00003578|Drug|CHOP regimen|
16377091|NCT00003578|Drug|carmustine|
16377092|NCT00003578|Drug|cyclophosphamide|
16377093|NCT00003578|Drug|cytarabine|
16377094|NCT00003578|Drug|doxorubicin hydrochloride|
16377095|NCT00003578|Drug|etoposide|
16377096|NCT00003578|Drug|melphalan|
16377097|NCT00003578|Drug|prednisone|
16377098|NCT00003578|Drug|vincristine sulfate|
16377099|NCT00003578|Procedure|autologous bone marrow transplantation|
16377100|NCT00003578|Procedure|peripheral blood stem cell transplantation|
16377101|NCT00076453|Device|Lateral wedge orthotic shoe inserts|Customized lateral wedge orthotic shoe inserts
16377102|NCT00076453|Device|Standard orthotic shoe inserts|Neutral orthotic inserts
16377103|NCT00076440|Drug|Leuprolide acetate|
16377104|NCT00076401|Drug|Motexafin gadolinium|
16377105|NCT00076388|Drug|Gefitinib|
16377106|NCT00076388|Drug|Docetaxel|
16377107|NCT00076375|Drug|Nanocrystalline silver cream (NPI)|
16377108|NCT00076362|Drug|Sandostatin LAR|
16377109|NCT00003541|Biological|filgrastim|
16377110|NCT00003541|Drug|CHOP regimen|
16377111|NCT00003541|Drug|carboplatin|
16377112|NCT00003541|Drug|cyclophosphamide|
16377113|NCT00003541|Drug|doxorubicin hydrochloride|
16377114|NCT00003541|Drug|etoposide|
16377115|NCT00003541|Drug|ifosfamide|
16377116|NCT00003541|Drug|prednisone|
16377117|NCT00003541|Drug|vincristine sulfate|
16377118|NCT00003541|Procedure|peripheral blood stem cell transplantation|
16377119|NCT00003541|Radiation|radiation therapy|
16377120|NCT00003418|Drug|exemestane|
16377121|NCT00003418|Drug|tamoxifen citrate|
16377122|NCT00003364|Drug|cisplatin|
16377123|NCT00003364|Drug|cyclophosphamide|
16377124|NCT00003364|Drug|doxorubicin hydrochloride|
16377125|NCT00003364|Drug|etoposide|
16377126|NCT00003364|Drug|vincristine sulfate|
16377127|NCT00003364|Radiation|radiation therapy|
16377128|NCT00003298|Drug|cisplatin|Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.
16377129|NCT00003298|Drug|fluorouracil|Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
16377249|NCT00075738|Drug|leucovorin calcium|
16377130|NCT00003298|Drug|leucovorin calcium|Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
16377131|NCT00003298|Drug|paclitaxel|Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.
16377132|NCT00003298|Procedure|surgery|"The surgical procedure performed involved a radical subtotal or total gastrectomy.
~A complete surgical resection was required"
16377133|NCT00003298|Radiation|radiation therapy|Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy
16377134|NCT00003287|Drug|FOLFOX regimen|
16377135|NCT00003287|Drug|fluorouracil|
16377136|NCT00003287|Drug|leucovorin calcium|
16377137|NCT00003287|Drug|oxaliplatin|
16377138|NCT00076414|Drug|Acetylcholine|
16377139|NCT00076414|Drug|L-NMMA|
16377140|NCT00076349|Drug|bendamustine and rituximab|Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
16377141|NCT00076336|Drug|Telbivudine|600mg/day oral tablet for 104 weeks
16377142|NCT00076336|Drug|Lamivudine|100mg/day oral tablet for 104 weeks
16377143|NCT00076336|Drug|Placebo|Telbivudine matching placebo or lamivudine matching placebo tablet.
16377144|NCT00003137|Drug|irinotecan hydrochloride|
16377145|NCT00003007|Biological|recombinant interferon alfa|
16377146|NCT00003007|Biological|sargramostim|
16377147|NCT00003007|Drug|cyclophosphamide|
16377148|NCT00003007|Drug|dexamethasone|
16377149|NCT00003007|Drug|melphalan|
16377150|NCT00003007|Procedure|peripheral blood stem cell transplantation|
16377151|NCT00002840|Drug|lomustine|
16377152|NCT00002840|Drug|procarbazine hydrochloride|
16377153|NCT00002840|Drug|vincristine sulfate|
16377154|NCT00002840|Radiation|radiation therapy|
16377155|NCT00002817|Biological|sargramostim|
16377156|NCT00002817|Biological|vaccinia-GM-CSF vaccine|
16377157|NCT00002748|Biological|gene-modified tumor cell vaccine therapy|
16377158|NCT00002748|Biological|interleukin-2 gene|
16377159|NCT00076323|Drug|Primaquine|
16377160|NCT00076310|Drug|Docetaxel|60 mg/m^2 IV repeated every 21 days.
16377161|NCT00076310|Drug|OSI-774|100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
16377162|NCT00076310|Drug|Cisplatin|75 mg/m^2 IV every 21 days.
16377163|NCT00076284|Drug|GW873140|
16377164|NCT00076258|Behavioral|SSRI + LD|Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
16377165|NCT00076258|Behavioral|SSRI + PHD|Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
16377166|NCT00076245|Behavioral|Light Therapy|Light therapy will involve exposure to bright light twice a day.
16377167|NCT00076245|Behavioral|Cognitive behavioral therapy (CBT)|CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
16377168|NCT00076219|Procedure|renal replacement therapy|renal replacement therapy
16377169|NCT00076206|Drug|CCI-779|
16377170|NCT00076206|Drug|Placebo|
16377171|NCT00076232|Drug|Acyclovir|400 mg tablet taken orally twice daily
16377172|NCT00076232|Drug|Acyclovir placebo|Oral tablet taken twice daily
16377173|NCT00076115|Drug|Risperidone|
16377174|NCT00076180|Biological|Hu-MiK-Beta-1|Hu-MiK-Beta-1 administered as an intravenous infusion over 90- minutes.
16377175|NCT00076089|Drug|Roflumilast|
16377176|NCT00076076|Drug|Roflumilast|
16377177|NCT00033735|Drug|fluorouracil|5-fluorouracil will be administered via central venous catheter or PICC beginning at 250mg/m2/ day as continous infusion for a 28 day period.
16377178|NCT00033735|Drug|Irofulven|Irofulven will be given at 0.55 mg/kg per infusion on Day 1 and and Day 15 every 28 days as a 30 minute iv infusion.
16377179|NCT00027508|Drug|trabectedin|
16377180|NCT00024401|Drug|DHA-paclitaxel|
16377181|NCT00002566|Drug|carboplatin|
16377182|NCT00002566|Drug|cisplatin|
16377183|NCT00002566|Drug|cyclophosphamide|
16377184|NCT00002566|Drug|etoposide|
16377185|NCT00002566|Drug|ifosfamide|
16377186|NCT00002566|Drug|vinblastine sulfate|
16377187|NCT00002566|Procedure|autologous bone marrow transplantation|
16377188|NCT00002566|Procedure|conventional surgery|
16377189|NCT00002566|Procedure|peripheral blood stem cell transplantation|
16377250|NCT00075725|Drug|Cyclophosphamide|Given IV
16377251|NCT00075725|Drug|Cytarabine|Given IT, SC, or IV
16377190|NCT00076102|Drug|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
16377191|NCT00076063|Biological|ALVAC-HIV (vCP1452)|experimental vaccine
16377192|NCT00076063|Biological|LIPO-5|experimental vaccine
16377193|NCT00076050|Dietary Supplement|Soy isoflavones|Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
16377194|NCT00076050|Dietary Supplement|Placebo|Placebo soy isoflavones
16377195|NCT00076037|Biological|HIV CTL MEP administered with RC529-SE adjuvant|
16377196|NCT00076037|Drug|GM-CSF|
16377197|NCT00076024|Drug|Placebo|5 mg twice daily [bid] continuous dosing
16377198|NCT00076024|Drug|Docetaxel|Standard of care drug administration
16377199|NCT00076024|Drug|AG-013736 (axitinib)|5mg twice daily [bid] continuous dosing
16377200|NCT00076024|Drug|Docetaxel|Standard of care drug administration
16377201|NCT00076011|Drug|Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor|
16377202|NCT00075998|Drug|"Interferon gamma-1b (Actimmune)"|200 mcg, SQ, 3x per week
16377203|NCT00075972|Behavioral|Mood Tolearance|
16377204|NCT00075972|Behavioral|Mood Management|
16377205|NCT00075972|Drug|Nicotine Replacement therapy|
16377206|NCT00075959|Drug|NXY-059|
16377207|NCT00075946|Biological|rituximab|Given IV
16377208|NCT00024388|Drug|DHA-paclitaxel|
16377209|NCT00022347|Drug|canfosfamide hydrochloride|
16377210|NCT00022321|Drug|gemtuzumab ozogamicin|
16377211|NCT00021333|Biological|filgrastim|
16377212|NCT00021333|Drug|cisplatin|
16377213|NCT00021333|Drug|paclitaxel|
16377214|NCT00021333|Radiation|radiation therapy|
16377215|NCT00021307|Drug|carboplatin|
16377216|NCT00021307|Drug|temozolomide|
16377217|NCT00075933|Drug|ARQ 501|
16377218|NCT00075907|Drug|Efavirenz + 2 NRTIs|
16377219|NCT00075907|Drug|Lopinavir/Ritonavir + 2 NRTIs|
16377220|NCT00075907|Procedure|Therapeutic Drug Monitoring|
16377221|NCT00075894|Drug|L-alanosine|
16377222|NCT00075881|Drug|bortezomib|Given IV
16377223|NCT00075881|Other|laboratory biomarker analysis|Optional correlative studies
16377224|NCT00075868|Drug|octreotide acetate|
16377225|NCT00075868|Other|Placebo|
16377226|NCT00075855|Drug|therapeutic testosterone|
16377227|NCT00075855|Other|placebo|
16377228|NCT00075842|Dietary Supplement|Valeriana officinalis extract|Given orally
16377229|NCT00075842|Other|placebo|Given orally
16377230|NCT00075829|Procedure|One Autologous Transplant|Melphalan will be administered at a dose of 200 mg/m2. Melphalan will be given in one dose infused on Day -2. Melphalan dose is based on ideal body weight (IBW) for patients who weigh 100-120% of their IBW. All patients will receive an autologous graft with a minimum cell dose of 2.0 x 106 CD34+ cells/kg patient weight. Patients will receive ~5 ug/kg/day of Granulocyte-Colony Stimulating Factor (G-CSF) subcutaneously from Day 5 post-transplant until absolute neutrophil count (ANC) > 500/mm3 for two days.
16377231|NCT00075829|Procedure|Non-Myeloablative Allogeneic Transplant|Upon recovery and at least Day 60 post-autograft, patients with an available 6/6 HLA matched sibling will receive an allograft after non-myeloablative conditioning. Day 0 patients will receive Total Body Irradiation (TBI) 2.0 Gy from a linear accelerator ≤ 20 cGy/min, followed by allogeneic peripheral blood stem cell (PBSC) infusion. Commence cyclosporine (CSA) on Day -3 at 5 mg/kg bid PO for a daily dose of 10 mg/kg/day through Day +84 based on actual body weight. Starting on Day 84, patients in partial or complete response with the absence of graph versus host disease (GVHD) will have CSA tapered so the patient will be off CSA by Day 180. Oral administration of Mycophenolate Mofetil will be at a daily dose of 30 mg/kg/day from the evening of Day 0 until Day 27 post-transplant.
16377232|NCT00075829|Procedure|Second Autologous Transplant|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients without an HLA-matched sibling donor will receive a second autograft, also conditioned with melphalan 200 mg/m2.
16377233|NCT00075829|Drug|Thalidomide|Patients will be initiated on a starting dose of 50 mg/day. The dose will be increased weekly by 50 mg as tolerated to achieve a target dose of 200 mg/day. Patients will be treated for 12 months with thalidomide.
16377234|NCT00075829|Drug|Dexamethasone|Patients will receive dexamethasone at a dose of 40 mg per day during Days 1-4 of each month for 12 months. The first dose of dexamethasone to be given the same day the patient starts thalidomide.
16377235|NCT00075829|Behavioral|Observation|One year of observation post-transplants.
16377236|NCT00075816|Biological|Allogeneic bone marrow transplantation|Bone marrow transplant from HLA compatible unrelated donors.
16377237|NCT00075816|Biological|Peripheral blood stem cell transplantation|Peripheral blood transplant from HLA compatible unrelated donors.
16377238|NCT00075803|Drug|Fluconazole|Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients > 12 years. For adults, each 200 mL infusion will be administered over 2 hours. In patients < 12 years, intravenous doses will be prepared.
16377239|NCT00075803|Drug|Voriconazole|Voriconazole will be administered orally twice daily. Voriconazole capsules should be taken at least one hour before or one hour after a meal. Taken concomitantly with food, bioavailability of voriconazole is reduced. If oral drug is not possible, it will be given intravenously at a dosage of 200 mg every 12 hours over two hours in patients > 12 years. Each voriconazole dose will be diluted to a total volume of 200 mL in patients > 12 years. Volumes of the formulation required to provide 4 mg/kg doses for children age < 12 years.
16377240|NCT00075777|Drug|valproic acid|250 mg by mouth twice a day
16377241|NCT00075764|Drug|anastrozole|Given orally
16377242|NCT00075764|Drug|fulvestrant|Given intramuscularly
16377243|NCT00075751|Drug|gemcitabine hydrochloride|Given IV
16377244|NCT00075751|Drug|carboplatin|Given IV
16377245|NCT00075751|Drug|bortezomib|Given IV
16377246|NCT00075738|Drug|cisplatin|
16377247|NCT00075738|Drug|fluorouracil|
16377248|NCT00075738|Drug|irinotecan hydrochloride|
16377252|NCT00075725|Drug|Daunorubicin Hydrochloride|Given IV
16377253|NCT00075725|Drug|Dexamethasone|Given PO or IV
16377254|NCT00075725|Drug|Doxorubicin Hydrochloride|Given IV
16377255|NCT00075725|Drug|Leucovorin Calcium|Given IV
16377256|NCT00075725|Drug|Mercaptopurine|Given PO
16377257|NCT00075725|Drug|Methotrexate|Given IT or IV
16377258|NCT00075725|Drug|Pegaspargase|Given IM
16377259|NCT00075725|Drug|Prednisone|Given PO or IV
16377260|NCT00075725|Radiation|Radiation Therapy|Undergo radiation therapy
16377261|NCT00075725|Drug|Thioguanine|Given PO
16377262|NCT00075725|Drug|Vincristine Sulfate|Given IV
16377263|NCT00075712|Drug|carboplatin|
16377264|NCT00075712|Drug|paclitaxel|
16377265|NCT00075712|Procedure|adjuvant therapy|
16377266|NCT00075712|Procedure|conventional surgery|
16377267|NCT00075712|Procedure|neoadjuvant therapy|
16377268|NCT00075699|Drug|cisplatin|
16377269|NCT00075699|Drug|mitomycin C|
16377270|NCT00075699|Drug|vincristine sulfate|
16377271|NCT00075699|Drug|vinorelbine tartrate|
16377272|NCT00075699|Procedure|pain therapy|
16377273|NCT00075699|Procedure|psychosocial assessment and care|
16377274|NCT00075699|Procedure|quality-of-life assessment|
16377275|NCT00075686|Biological|cetuximab|Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles
16377276|NCT00075686|Drug|gemcitabine hydrochloride|1000mg/m2 IV over 30 minutes
16377277|NCT00075673|Drug|celecoxib|Patients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
16377278|NCT00075673|Drug|vinorelbine ditartrate|Patients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
16377279|NCT00075660|Drug|triapine|
16377280|NCT00075647|Drug|temsirolimus|Given IV
16377281|NCT00075647|Other|laboratory biomarker analysis|Correlative studies
16377282|NCT00075634|Drug|decitabine|Given IV
16377283|NCT00075634|Drug|doxorubicin hydrochloride|Given IV
16377284|NCT00075634|Drug|cyclophosphamide|Given IV
16377285|NCT00075634|Biological|filgrastim|Given SC
16377286|NCT00075634|Biological|pegfilgrastim|Given SC
16377287|NCT00075634|Other|laboratory biomarker analysis|Correlative studies
16377288|NCT00075634|Other|pharmacological study|Correlative studies
16377289|NCT00075621|Drug|filgrastim|16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection
16377290|NCT00075621|Drug|melphalan|200 mg/kg over 2 days
16377291|NCT00075621|Procedure|autologous peripheral blood stem cell transplantation|autologous peripheral blood stem cell transplantation
16377292|NCT00075608|Biological|filgrastim|16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
16377293|NCT00075608|Drug|melphalan|140-200 mcg/kg IV over two days
16377294|NCT00075608|Procedure|autologous stem cell transplantation|infusion of previously collected stem cells on Day 0
16377295|NCT00075608|Procedure|stem cell infusion|infusion of previously collected stem cells on Day 0
16377296|NCT00075595|Drug|FOLFIRI regimen|
16377297|NCT00075595|Drug|fluorouracil|
16377298|NCT00075595|Drug|irinotecan hydrochloride|
16377299|NCT00075595|Drug|leucovorin calcium|
16377300|NCT00075582|Procedure|conventional surgery|Some patients may undergo second-look surgery
16377301|NCT00075582|Drug|dactinomycin|Given IV
16377302|NCT00075582|Drug|cyclophosphamide|Given IV
16377303|NCT00075582|Drug|vincristine sulfate|Given IV
16377304|NCT00075582|Radiation|radiation therapy|Undergo radiotherapy
16377305|NCT00075569|Biological|HspE7|500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.
16377306|NCT00075556|Drug|capecitabine|
16377307|NCT00075556|Procedure|conventional surgery|
16377308|NCT00075556|Procedure|neoadjuvant therapy|
16377309|NCT00075556|Radiation|radiation therapy|
16377310|NCT00075543|Drug|docetaxel|
16377311|NCT00075543|Drug|oxaliplatin|
16377312|NCT00075517|Drug|docetaxel|
16377313|NCT00075517|Drug|gemcitabine hydrochloride|
16377314|NCT00075504|Drug|triapine|Given IV
16377315|NCT00075504|Drug|gemcitabine|Given IV
16377316|NCT00075491|Drug|fenretinide|Given orally
16377317|NCT00075491|Procedure|therapeutic conventional surgery|Undergo surgery
16377318|NCT00075491|Other|pharmacological study|Correlative studies
16377319|NCT00075491|Other|laboratory biomarker analysis|Correlative studies
16377320|NCT00075478|Procedure|Total-Body Irradiation|Undergo TBI
16377321|NCT00075478|Drug|Fludarabine Phosphate|Given IV
16377322|NCT00075478|Drug|Mycophenolate Mofetil|Given PO
16377323|NCT00075478|Drug|Cyclosporine|Given PO
16377324|NCT00075478|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo transplantation
16377325|NCT00075465|Drug|docetaxel|
16377326|NCT00075465|Drug|epirubicin hydrochloride|
16377327|NCT00075452|Drug|gemcitabine hydrochloride|
16377328|NCT00075452|Drug|oxaliplatin|
16377329|NCT00075439|Drug|gefitinib|Given orally
16377330|NCT00075439|Other|laboratory biomarker analysis|Correlative studies
16377331|NCT00075426|Drug|arsenic trioxide|
16377332|NCT00075413|Drug|arsenic trioxide|
16377333|NCT00075400|Drug|imatinib mesylate|Given PO
16377334|NCT00075400|Other|laboratory biomarker analysis|Correlative studies
16377335|NCT00075387|Drug|Carboplatin|Given IA
16377336|NCT00075387|Drug|Cyclophosphamide|Given IV
16377337|NCT00075387|Drug|Etoposide Phosphate|Given IV
16377338|NCT00075387|Other|Quality-of-Life Assessment|Ancillary studies
16377339|NCT00075387|Drug|Sodium Thiosulfate|Given IV
16377340|NCT00075374|Drug|docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
~OR Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
~Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion.
~Patients are followed at 1 month and then every 2-3 months thereafter."
16377341|NCT00075348|Genetic|mutation analysis|
16377342|NCT00075335|Drug|AMD3100 (Mozobil plerixafor)|AMD 3100 (Mozobil plerixafor)mobilized peripheral blood hematopoietic progenitor cells from healthy volunteers will be characterized by cellular content and immunological properties.
16377343|NCT00075283|Device|Lokomat (Robotic Orthosis) combined with slat belt treadmill|
16377344|NCT00075270|Drug|Paclitaxel|Active Comparator
16377345|NCT00075270|Drug|GW572016 (Lapatinib)|Oral GW572016 Lapatinib
16377346|NCT00075257|Drug|DVS-233 SR|
16377347|NCT00075231|Drug|Kaletra® (lopinavir/ritonavir)|
16377348|NCT00075231|Drug|Combivir® (lamivudine, zidovudine)|
16377349|NCT00075231|Drug|Sustiva® (efavirenz)|
16377350|NCT00075218|Drug|Placebo|50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
16377351|NCT00075218|Drug|SU011248|50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
16377352|NCT00020787|Biological|G17DT Immunogen|Dose: 500 micrograms in 0.2mL Route: Deep intramuscular Schedule: Days 8, 36, and 64; an additional dose at week 2, cycle 7 will be administered
16377353|NCT00020787|Drug|cisplatin|dose: 100 mg/m2 Route: i.v. infusion in 500 mL in 0.9% NaCl administered up to 3 hours Schedule: day 1, and then every 4 weeks.
16377354|NCT00020787|Drug|fluorouracil|Dose: 1000mg/m2/day Route: 24-hour continuous infusion in 0.9% NaCl over 5 days Schedule: Day 1 to Day 5 (5-day infusion) and then every 4 weeks
16377355|NCT00017576|Dietary Supplement|calcitriol|
16377356|NCT00017576|Drug|carboplatin|
16377357|NCT00017537|Biological|MVF-HER-2(628-647)-CRL 1005 vaccine|
16377358|NCT00017433|Drug|arsenic trioxide|
16377359|NCT00075244|Drug|Replagal|
16377360|NCT00075192|Drug|CP-675,206 and leuprolide acetate and bicalutamide|
16377361|NCT00075192|Drug|leuprolide acetate and bicalutamide|
16377362|NCT00017082|Drug|oxaliplatin|
16377363|NCT00016237|Biological|tucotuzumab celmoleukin|
16377364|NCT00016198|Drug|FOLFOX regimen|
16377365|NCT00016198|Drug|fluorouracil|
16377366|NCT00016198|Drug|leucovorin calcium|
16377367|NCT00016198|Drug|oxaliplatin|
16377368|NCT00014404|Drug|celecoxib|
16377369|NCT00014287|Drug|gemcitabine hydrochloride|
16377370|NCT00075205|Drug|SR141716 (Rimonabant)|
16377371|NCT00075179|Drug|Nesiritide (Natrecor)|Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization.
16377372|NCT00075179|Procedure|Right Heart Catheterization|Small tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure.
16377373|NCT00075166|Procedure|Stereotactic surgery (SRS)|
16377374|NCT00075166|Procedure|Craniotomy|
16377375|NCT00075140|Genetic|Mutation in the gene|
16377376|NCT00075114|Behavioral|Bladder Health Class|A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.
16377377|NCT00075101|Drug|Dexamethosone|10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
16377378|NCT00075088|Device|Electrocardiogram (ECG) Intervention|"Pre-hospital electrocardiographic (ECG) monitoring with special software to detect myocardial ischemia and to automatically transmit an ECG to the destination hospital emergency department with a voice alarm announcing Incoming ECG from the field and print out in the ED."
16377379|NCT00075088|Other|Routine Clinical Practice|ECG in the ED as part of routine clinical practice.
16377380|NCT00075075|Drug|Infliximab|
16377381|NCT00075062|Procedure|Flexible Sigmoidoscopy|
16377382|NCT00075062|Procedure|Rectal Biopsy|
16377383|NCT00075049|Biological|RTS,S with AS02A/AS01B adjuvant|
16377384|NCT00014183|Drug|gefitinib|
16377385|NCT00012116|Drug|temozolomide|Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.
16377386|NCT00009919|Drug|semaxanib|Given IV
16377387|NCT00009893|Drug|fluorouracil|
16377388|NCT00009893|Drug|gemcitabine hydrochloride|
16377389|NCT00009893|Drug|leucovorin calcium|
16377390|NCT00075023|Drug|Thalidomide Gel|
16377391|NCT00075023|Drug|Placebo Gel|
16377392|NCT00075010|Drug|Decitabine|15 mg/m^2 by vein over 1 hour times 10 days
16377393|NCT00075010|Drug|Valproic acid|20 mg/kg given orally daily for 10 days
16377394|NCT00074997|Other|Placebo|Single intravenous infusion of placebo.
16377395|NCT00074997|Genetic|OZ1|Single intravenous infusion of OZ1.
16377396|NCT00074997|Genetic|CD34+ cells|Autologous CD34+ cells.
16377397|NCT00009867|Drug|arsenic trioxide|Given IV
16377398|NCT00009698|Biological|aldesleukin|Given SQ and IV
16377399|NCT00006481|Drug|Biafine cream|
16377400|NCT00006481|Procedure|quality-of-life assessment|
16377401|NCT00006481|Radiation|radiation therapy|
16377402|NCT00006480|Biological|aldesleukin|
16377403|NCT00006480|Biological|therapeutic autologous lymphocytes|
16377404|NCT00006480|Drug|chemotherapy|
16377405|NCT00006480|Drug|ganciclovir|
16377406|NCT00074984|Biological|Fabrazyme (agalsidase beta)|1mg/kg Fabrazyme (agalsidase beta) every 2 weeks
16377407|NCT00074984|Biological|Placebo|1 mg/kg placebo intravenously every 2 weeks
16377408|NCT00074971|Drug|Fabrazyme (agalsidase beta)|
16377409|NCT00074958|Biological|Fabrazyme (agalsidase beta)|1 mg/kg every 2 weeks
16377410|NCT00074932|Biological|Myozyme|20 mg/kg
16377411|NCT00074919|Biological|alglucosidase alfa|20 mg/kg qow
16377412|NCT00074906|Drug|Venticute|Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
16377413|NCT00074893|Device|piezoelectric wrist brace|
16377414|NCT00074867|Drug|CP-547,632|
16377415|NCT00074854|Drug|CP-547,632|
16377416|NCT00074841|Drug|Azithromycin/Chloroquine|
16377417|NCT00074841|Drug|Sulfadoxine-Pyrimethamine/Chloroquine|
16377418|NCT00006384|Biological|recombinant interferon alfa|
16377419|NCT00006384|Drug|semaxanib|
16377420|NCT00006353|Drug|temozolomide|
16377421|NCT00006353|Radiation|radiation therapy|
16377422|NCT00006247|Drug|semaxanib|
16377423|NCT00006213|Drug|BMS-214662|Given IV
16377424|NCT00006213|Other|pharmacological study|Correlative studies
16377425|NCT00006213|Other|laboratory biomarker analysis|Correlative studies
16377426|NCT00006104|Biological|trastuzumab|
16377427|NCT00006104|Drug|docetaxel|
16377428|NCT00074828|Drug|LY517717|
16377429|NCT00074828|Drug|enoxaparin|
16377430|NCT00074763|Biological|Platelet Transfusion|All receive both platelets frozen with Thrombosol and fresh random platelets (FRP), order received is randomized, i.e. receive either FRP then Thrombosol or Thrombosol then FRP.
16377431|NCT00074750|Drug|DTGM|Starting dose: 2 mcg/kg by vein three times a week (M,W,F) for two consecutive weeks.
16377432|NCT00074737|Drug|cenersen|cenersen with standard of care
16377433|NCT00074737|Drug|Idarubicin|standard of care for AML
16377434|NCT00074737|Drug|Cytarabine|standard of care Ara-C and High dose Ara-C
16377435|NCT00074724|Procedure|Coronary Artery Bypass|coronary revascularization using arterial or vein conduits
16377436|NCT00074724|Drug|Modern medical management|Therapies with evidence-based recommendations.
16377437|NCT00074724|Device|Dobutamine echocardiography|Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
16377438|NCT00074724|Drug|Optimal medical therapy|All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.
16377439|NCT00006099|Biological|Monoclonal antibody hu3S193|Hu3S193 was to be administered intraperitoneally or intravenously at a dose of 5mg. Doses of hu3S193 were radiolabeled with 5 mCi of 111In.
16377440|NCT00006087|Procedure|annual screening|
16377441|NCT00006087|Procedure|bronchoscopic and lung imaging studies|
16377442|NCT00006087|Procedure|comparison of screening methods|
16377443|NCT00006087|Procedure|computed tomography|
16377444|NCT00006087|Procedure|radiography|
16377445|NCT00006087|Procedure|study of high risk factors|
16377446|NCT00006080|Drug|fenretinide|
16377447|NCT00005978|Biological|filgrastim|
16377448|NCT00005978|Drug|carboplatin|
16377449|NCT00005978|Drug|etoposide|
16377450|NCT00005978|Drug|melphalan|
16377451|NCT00005978|Procedure|autologous bone marrow transplantation|
16377452|NCT00005978|Procedure|peripheral blood stem cell transplantation|
16377453|NCT00005978|Radiation|iobenguane I 131|
16377454|NCT00005978|Radiation|radiation therapy|
16377455|NCT00005963|Drug|carboplatin|
16377456|NCT00005963|Drug|docetaxel|
16377457|NCT00074815|Drug|Serotonin reuptake inhibitors management|"Participants are maintained on their optimized dose of SRI for OCD symptoms (see Other Names section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI."
16377458|NCT00074815|Behavioral|Cognitive behavioral therapy by a psychologist|CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.
16377459|NCT00074815|Behavioral|Instructional cognitive behavioral therapy by a psychiatrist|"The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor best practice treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy."
16377460|NCT00074802|Drug|Paroxetine|Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
16377461|NCT00074802|Behavioral|Cognitive behavioral therapy (CBT)|CBT will consist of 16 weekly treatment sessions.
16377462|NCT00074789|Behavioral|Modified Interpersonal Therapy|Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.
16377463|NCT00074789|Behavioral|Attention control/usual care|Participants will receive the usual care for depression.
16377464|NCT00074776|Drug|Lithium|Participants will receive lithium.
16377465|NCT00074776|Drug|Lamotrigine|Participants will receive lamotrigine.
16377466|NCT00074711|Drug|Calcium carbonate|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
16377467|NCT00074711|Drug|Calcium Phosphate|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
16377468|NCT00074698|Drug|FG-3019|
16377469|NCT00074646|Drug|CC-8490|
16377470|NCT00074633|Behavioral|Health at Every Size (HAES)|
16377471|NCT00074633|Behavioral|Diet (Traditional, moderate energy restriction)|
16377472|NCT00074620|Drug|PEG-hirudin|
16377521|NCT00074438|Drug|rituximab|Intravenous repeating dose
16377909|NCT00072826|Drug|L-NMMA|
16377473|NCT00074607|Drug|Gemcitabine|"Schedule
~Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses).
~In the absence of disease progression or DLT, patients may proceed to consolidation.
~Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance.
~Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year."
16377474|NCT00074581|Drug|Atazanavir|300 mg taken orally once daily
16377475|NCT00074581|Drug|Didanosine|400 mg taken orally once daily
16377476|NCT00074581|Drug|Efavirenz|600 mg taken orally once daily
16377477|NCT00074581|Drug|Emtricitabine/Tenofovir disoproxil fumarate|200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
16377478|NCT00074581|Drug|Lamivudine|300 mg taken orally once daily
16377479|NCT00074581|Drug|Lopinavir/Ritonavir|200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
16377480|NCT00074581|Drug|Nevirapine|200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
16377481|NCT00074581|Drug|Stavudine|Dosage depends on weight
16377482|NCT00074581|Drug|Tenofovir disoproxil fumarate|300 mg taken orally once daily
16377483|NCT00074581|Drug|Zidovudine/Lamivudine|150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
16377484|NCT00005959|Biological|filgrastim|
16377485|NCT00005959|Biological|rituximab|
16377486|NCT00005959|Drug|cyclophosphamide|
16377487|NCT00005959|Drug|doxorubicin hydrochloride|
16377488|NCT00005959|Drug|prednisone|
16377489|NCT00005959|Drug|vincristine sulfate|
16377490|NCT00005876|Drug|rubitecan|
16377491|NCT00005646|Drug|paclitaxel|150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle
16377492|NCT00005642|Drug|semaxanib|This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined.
16377493|NCT00005634|Drug|vorinostat|
16377494|NCT00074542|Drug|Epanova™ (Omega-3 Free Fatty Acids)|
16377495|NCT00074529|Drug|MK0677|
16377496|NCT00005598|Drug|amifostine trihydrate|
16377497|NCT00005598|Drug|azacitidine|
16377498|NCT00005592|Biological|90-Y-ibritumomab tiuxetan|IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
16377499|NCT00005592|Biological|rituximab|Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
16377500|NCT00005592|Radiation|indium In 111 ibritumomab tiuxetan|IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
16377501|NCT00005083|Procedure|conventional surgery|
16377502|NCT00005083|Procedure|magnetic resonance imaging|
16377503|NCT00005083|Procedure|magnetic resonance spectroscopic imaging|
16377504|NCT00004890|Biological|aldesleukin|
16377505|NCT00004890|Drug|Biomed 101|
16377506|NCT00004874|Radiation|tositumomab and iodine I 131 tositumomab|Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.
16377507|NCT00074490|Drug|Rituximab|Rituximab: 375 mg/m(2)/day intravenous (IV), day 1 (for cluster of differentiation 20 (CD20+) patients).
16377508|NCT00074490|Drug|Fludarabine|Fludarabine: 30 mg/m(2)/day intravenous (IV), days -6 to -3.
16377509|NCT00074490|Drug|Etoposide|Etoposide: 50 mg/m(2)/day continuous intravenous (CIV), days 1-4.
16377510|NCT00074490|Drug|Doxorubicin|Doxorubicin:10 mg/m(2)/day continuous intravenous (CIV), days 1-4.
16377511|NCT00074490|Drug|Vincristine|Vincristine: 0.4 mg/m(2)/day continuous intravenous (CIV), days 1-4.
16377512|NCT00074490|Drug|Cyclophosphamide|Cyclophosphamide, 300 mg/m(2)/day intravenous (IV), days -6 to -3.
16377513|NCT00074490|Procedure|Peripheral blood stem cell (PBSC) transplantation|PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell.
16377514|NCT00074490|Genetic|T cell donor lymphocyte infusion (DLI) with unmanipulated donor T cells|The dose of the T cells will attempt to be held constant for each study recipient (target dose 2.5 x 10(7) T cells/kg; minimum dose will be 1 x 10(7) T cells/kg).
16377515|NCT00074490|Drug|Prednisone|Prednisone: 60 mg/m(2)/day by mouth (PO), days 1-5.
16377516|NCT00074490|Procedure|Allogeneic hematopoietic stem cell transplant (HSCT)|Allogeneic Hematopoietic Stem Cell Transplant.
16377517|NCT00074490|Drug|Filgrastim|Filgrastim: 5 mcg/kg/day subcutaneous (SC), day 6 (require absolute neutrophil count (ANC) > 1000, two values; or ANC > 5000 cells/ul on one occasion).
16377518|NCT00074490|Genetic|T-Rapa cell Donor Lymphocyte Infusion (DLI)|The dose of T helper 2 (Th2) cells or unmanipulated donor T cells will attempt to be held constant for each study recipient (target dose 2.5 x 10(7) Th2/kg; minimum dose will be 1 x 10(7) Th2/kg).
16377519|NCT00074477|Drug|R092670|
16377520|NCT00074438|Drug|methotrexate|Oral or parenteral repeating dose
16377522|NCT00074438|Drug|corticosteroids|Intravenous repeating dose
16377523|NCT00074438|Drug|placebo|Intravenous repeating dose
16377524|NCT00074425|Drug|BufferGel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
16377525|NCT00074425|Drug|PRO 2000/5 Gel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
16377526|NCT00074425|Drug|Placebo gel|Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.
16377527|NCT00074412|Drug|Nevirapine|10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.
16377528|NCT00074412|Drug|Nevirapine placebo|Oral suspension taken once daily up to 6 months of age
16377529|NCT00074399|Drug|Nevirapine|Tablet taken orally daily. Dosage depends on age and body surface area
16377530|NCT00074399|Drug|Nevirapine placebo|Placebo tablet taken orally daily
16377531|NCT00074373|Other|No intervention; observational|
16377532|NCT00021983|Biological|BL22 immunotoxin|
16377533|NCT00008177|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
16377534|NCT00008177|Radiation|total-body irradiation|Undergo total-body irradiation
16377535|NCT00008177|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16377536|NCT00008177|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16377537|NCT00008177|Drug|fludarabine phosphate|Given IV
16377538|NCT00008177|Drug|cyclosporine|Given orally or IV
16377539|NCT00008177|Drug|mycophenolate mofetil|Given orally or IV
16377540|NCT00008177|Other|laboratory biomarker analysis|Correlative studies
16377541|NCT00074334|Biological|TGFa-PE38 immunotoxin|
16377542|NCT00074334|Procedure|conventional surgery|
16377543|NCT00074321|Drug|irinotecan hydrochloride|Given IV
16377544|NCT00074321|Drug|oxaliplatin|Given IV
16377545|NCT00074321|Drug|capecitabine|Given PO
16377546|NCT00074321|Other|laboratory biomarker analysis|Correlative studies
16377547|NCT00074321|Other|pharmacological study|Correlative studies
16377548|NCT00074308|Drug|imatinib mesylate|Given orally
16377549|NCT00074308|Biological|bevacizumab|Given IV
16377550|NCT00074308|Other|pharmacological study|Correlative studies
16377551|NCT00074308|Other|laboratory biomarker analysis|Correlative studies
16377552|NCT00074295|Biological|GVAX lung cancer vaccine|6-7 injections per week in rotating locations for five weeks
16377553|NCT00074282|Biological|rituximab|
16377554|NCT00074282|Drug|cyclophosphamide|
16377555|NCT00074282|Drug|pentostatin|
16377556|NCT00074282|Drug|Alemtuzumab|
16377557|NCT00074269|Biological|anti-thymocyte globulin|
16377558|NCT00074269|Biological|filgrastim|
16377559|NCT00074269|Biological|graft-versus-tumor induction therapy|
16377560|NCT00074269|Biological|therapeutic allogeneic lymphocytes|
16377561|NCT00074269|Drug|cyclosporine|
16377562|NCT00074269|Drug|fludarabine phosphate|
16377563|NCT00074269|Drug|melphalan|
16377564|NCT00074269|Drug|methotrexate|
16377565|NCT00074269|Procedure|peripheral blood stem cell transplantation|
16377566|NCT00074243|Drug|CC-8490|
16377567|NCT00074230|Biological|Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin|Within cohort 1 patients received the vaccine intradermally; in cohort 2 the route of Administration was intravenous Infusion, half of the patients had additional loading with RNA coding for EL-Selektin; in cohort 3 the vaccines was again infused intravenously, the cells were matured not with MCM.mimic as in cohort 1 and 2 but either with TriMix or MCM-mimic plus CD40L-RNA.
16377568|NCT00074204|Drug|carboplatin|Carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16377569|NCT00074204|Drug|docetaxel|"Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
~Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
~In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity."
16377570|NCT00074204|Drug|gemcitabine hydrochloride|Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16377571|NCT00074191|Drug|cytarabine|
16377572|NCT00074191|Drug|dexamethasone|
16377573|NCT00074191|Drug|lomustine|
16377574|NCT00074191|Drug|methotrexate|
16377575|NCT00074191|Drug|procarbazine hydrochloride|
16377576|NCT00074178|Biological|filgrastim|
16377577|NCT00074178|Biological|pegfilgrastim|
16377578|NCT00074178|Drug|cyclophosphamide|
16377579|NCT00074178|Drug|cytarabine|
16377580|NCT00074178|Drug|dexamethasone|
16377581|NCT00074178|Drug|etoposide phosphate|
16377582|NCT00074178|Drug|methotrexate|
16377583|NCT00074165|Drug|Rituxan|Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.
16377584|NCT00074165|Drug|Cyclophosphamide|Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year
16377585|NCT00074165|Drug|Etoposide|Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.
16377586|NCT00074165|Drug|Etoposide phosphate|Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.
16377587|NCT00074165|Drug|Carboplatin|Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.
16377588|NCT00074165|Drug|Sodium thiosulfate|"Dose: 4 hrs post carboplatin = 20gm/m2;
~Dose: 8 hrs post carboplatin = 16gm/m2
~Infused IV x 2 days"
16377589|NCT00074165|Drug|Neupogen|48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.
16377910|NCT00072826|Drug|Acetylcholine|
16377590|NCT00074165|Drug|Neulasta|Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.
16377591|NCT00074165|Drug|Cytarabine|Dose: 40mg on Day 14 following chemotherapy
16377592|NCT00074152|Drug|chemotherapy|Given within 10 weeks after surgery.
16377593|NCT00074152|Radiation|radiation therapy|Given within 6 months after surgery
16377594|NCT00074139|Drug|cyclophosphamide|
16377595|NCT00074139|Drug|docetaxel|
16377596|NCT00074139|Drug|doxorubicin hydrochloride|
16377597|NCT00074100|Drug|amonafide dihydrochloride|
16377598|NCT00074087|Drug|pegylated liposomal doxorubicin hydrochloride|
16377599|NCT00074074|Biological|infliximab|
16377600|NCT00074048|Drug|BL22|Dosing via IV on Days 1,3, and 5.
16377601|NCT00074035|Drug|pentostatin|4 mg/sq m IV infusion over 20-30 min q 2 weeks
16377602|NCT00074022|Biological|GTI-2040|Given IV
16377603|NCT00074022|Drug|docetaxel|Given IV
16377604|NCT00074022|Other|laboratory biomarker analysis|Correlative studies
16377605|NCT00074022|Other|pharmacological study|Correlative studies
16377606|NCT00074009|Drug|bortezomib|
16377607|NCT00073983|Biological|filgrastim|filgrastim
16377608|NCT00073983|Biological|pegfilgrastim|pegfilgrastim
16377609|NCT00073983|Drug|docetaxel|docetaxel
16377610|NCT00073983|Drug|gemcitabine hydrochloride|gemcitabine hydrochloride
16377611|NCT00073983|Genetic|microarray analysis|microarray analysis
16377612|NCT00073983|Other|laboratory biomarker analysis|laboratory biomarker analysis
16377613|NCT00073983|Other|pharmacokinetic study|pharmacokinetic study
16377614|NCT00073970|Drug|celecoxib|400mg, given twice daily
16377615|NCT00073957|Biological|rituximab|
16377616|NCT00073957|Drug|cytarabine|to be used for CNS prophylaxis
16377617|NCT00073957|Drug|liposomal cytarabine|to be used as CNS prophylaxis
16377618|NCT00073957|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16377619|NCT00073944|Drug|forodesine hydrochloride|
16377620|NCT00073931|Biological|filgrastim|5 µg/kg/day subcutaneously
16377621|NCT00073931|Biological|sargramostim|250µg/m2/d subcutaneously
16377622|NCT00073931|Procedure|autologous bone marrow transplantation|autologous stem cells given via central catheter
16377623|NCT00073931|Procedure|peripheral blood stem cell transplantation|autologous stem cells given via central catheter
16377624|NCT00073931|Radiation|tositumomab and iodine I 131 tositumomab|given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with ~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
16377625|NCT00073918|Drug|cyclophosphamide|Given IV
16377626|NCT00073918|Drug|etoposide|Given IV
16377627|NCT00073918|Radiation|iodine I 131 tositumomab|Given IV
16377628|NCT00073918|Procedure|quality-of-life assessment|Ancillary study
16377629|NCT00073918|Procedure|peripheral blood stem cell transplantation|Undergo ASCT given via central catheter
16377630|NCT00073905|Drug|capecitabine plus gemcitabine|capecitabine plus gemcitabine
16377631|NCT00073892|Drug|PI-88|250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
16377632|NCT00073879|Biological|alemtuzumab|
16377633|NCT00073879|Biological|graft-versus-tumor induction therapy|
16377634|NCT00073879|Drug|cyclophosphamide|
16377635|NCT00073879|Drug|fludarabine phosphate|
16377636|NCT00073879|Procedure|allogeneic bone marrow transplantation|
16377637|NCT00073879|Procedure|peripheral blood stem cell transplantation|
16377638|NCT00073866|Drug|celecoxib|
16377639|NCT00073866|Drug|docetaxel|
16377640|NCT00073866|Drug|irinotecan hydrochloride|
16377641|NCT00073853|Procedure|Autologous Incubated Macrophages (cell therapy)|
16377642|NCT00073840|Drug|levalbuterol|"Levalbuterol 90 ųg QID (manufacturing sites A or B);
~Racemic Albuterol 180 ųg QID;
~Placebo QID"
16377643|NCT00073827|Drug|levalbuterol tartrate MDI|levalbuterol 90 mcg QID
16377644|NCT00073827|Drug|racemic albuterol MDI|racemic albuterol 180 mcg QID
16377645|NCT00073827|Drug|Placebo|Placebo MDI QID
16377646|NCT00004857|Biological|alemtuzumab|30 mg subQ injection tiw for 6 weeks
16377647|NCT00004857|Drug|fludarabine phosphate|25mg/sq m/day IV infusion x 5 days Wks 1, 5, 9, and 13
16377648|NCT00004261|Drug|EF5|
16377649|NCT00004261|Other|flow cytometry|
16377650|NCT00004261|Other|fluorescent antibody technique|
16377651|NCT00004261|Other|immunohistochemistry staining method|
16377652|NCT00004261|Procedure|biopsy|
16377653|NCT00004242|Drug|fluorouracil|
16377654|NCT00004242|Drug|gemcitabine hydrochloride|
16377655|NCT00004242|Drug|oxaliplatin|
16377656|NCT00003927|Biological|filgrastim|
16377657|NCT00003927|Drug|amifostine trihydrate|
16377658|NCT00003927|Drug|cyclophosphamide|
16377659|NCT00003927|Drug|doxorubicin hydrochloride|
16377660|NCT00003927|Drug|paclitaxel|
16377661|NCT00003927|Procedure|peripheral blood stem cell transplantation|
16377662|NCT00073814|Drug|Levalbuterol tartrate MDI|levalbuterol MDI 90 mcg QID
16377663|NCT00073814|Drug|racemic albuterol MDI|racemic albuterol MDI 180 mcg QID
16377664|NCT00073814|Drug|Placebo|Placebo MDI QID
16377665|NCT00073788|Procedure|PET Scans|PET Scan to look for coronary flow reserve, heart rate variability, and carotid ultrasound measures (mean intermediate thickness of the far fall of the carotid artery).
16377666|NCT00003811|Biological|bleomycin sulfate|
16377667|NCT00003811|Drug|amifostine trihydrate|
16377668|NCT00003811|Drug|cisplatin|
16377669|NCT00003811|Drug|etoposide|
16377670|NCT00003811|Procedure|conventional surgery|
16377671|NCT00003777|Drug|amifostine trihydrate|
16377672|NCT00003777|Drug|cisplatin|
16377673|NCT00003777|Drug|fluorouracil|
16377674|NCT00003777|Procedure|surgical procedure|
16377675|NCT00003777|Radiation|radiation therapy|
16377827|NCT00073346|Behavioral|Cognitive Behavioral Treatment|
16377911|NCT00072709|Drug|TCH346|
16377676|NCT00003761|Biological|rV-DF3/MUC1|"- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU.
~-- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination
~Level 1 4.76 x 106 PFU
~Level 2 4.76 x 107 PFU
~Level 3 4.76 x 108 PFU"
16377677|NCT00003729|Drug|cytarabine|
16377678|NCT00003729|Drug|fludarabine phosphate|
16377679|NCT00003729|Drug|idarubicin|
16377680|NCT00003734|Drug|flutamide|
16377681|NCT00003734|Drug|triptorelin|
16377682|NCT00003734|Radiation|radiation therapy|
16377683|NCT00073762|Drug|DVS-233 SR|
16377684|NCT00073749|Drug|Inotuzumab ozogamicin [CMC-544]|CMC-544, IV, dose escalation trial
16377685|NCT00073736|Drug|MB07133 300mg/m2/day|7-day continuous infusion in 28-day cycles
16377686|NCT00073736|Drug|MB07133 600 mg/m2/day|7-day continuous infusion in 28-day cycles
16377687|NCT00073736|Drug|MB07133 1200 mg/m2/day|7-day continuous infusion in 28-day cycles
16377688|NCT00073736|Drug|MB07133 1800 mg/m2/day|7-day continuous infusion in 28-day cycles
16377689|NCT00073736|Drug|MB07133 2400 mg/m2/day|7-day continuous infusion in 28-day cycles
16377690|NCT00073723|Drug|ABI-007|
16377691|NCT00003716|Biological|rituximab|
16377692|NCT00003694|Drug|omacetaxine mepesuccinate|Given IV
16377693|NCT00003694|Drug|cytarabine|Given IV
16377694|NCT00003694|Other|laboratory biomarker analysis|Correlative studies
16377695|NCT00003679|Drug|cyclophosphamide|
16377696|NCT00003679|Drug|docetaxel|
16377697|NCT00003679|Drug|doxorubicin hydrochloride|
16377698|NCT00003679|Drug|tamoxifen citrate|
16377699|NCT00003679|Procedure|conventional surgery|
16377700|NCT00003679|Radiation|radiation therapy|
16377701|NCT00003598|Drug|tretinoin|
16377702|NCT00003450|Biological|Ad5CMV-p53 gene|
16377703|NCT00073710|Drug|Zemplar|
16377704|NCT00073710|Procedure|42 Ca carbonate absorption via single tracer method|
16377705|NCT00073710|Drug|Calcijex|
16377706|NCT00073697|Drug|Escitalopram|Participants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months.
16377707|NCT00073697|Behavioral|Interpersonal Psychotherapy|Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
16377708|NCT00073697|Other|Escitalopram plus IPT|Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs.
16377709|NCT00073684|Behavioral|Trauma focused cognitive behavioral therapy (TF-CBT)|This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
16377710|NCT00073684|Behavioral|Brief abuse-focused treatment|Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.
16377711|NCT00073684|Behavioral|Brief coping skills treatment|Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.
16377712|NCT00073684|Behavioral|Extended abuse-focused treatment|Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.
16377713|NCT00073684|Behavioral|Extended coping skills treatment|Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.
16377714|NCT00073671|Behavioral|Cognitive-behavioral prevention program|Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
16377715|NCT00073671|Other|Usual care|Participants receive usual care
16377716|NCT00073658|Drug|Citalopram|
16377717|NCT00073658|Drug|Risperidone|
16377718|NCT00073645|Behavioral|Peer/Group CBT|Children will be trained to be more helpful and positive toward other children through role-playing activities.
16377719|NCT00073645|Behavioral|Family/Parents CBT|Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
16377720|NCT00073632|Behavioral|Acceptance Based Behavioral Therapy|
16377721|NCT00073619|Behavioral|Cognitive-behavioral group therapy|School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence. Participants received the weekly intervention and rewards for participating in the assessments.
16377722|NCT00003426|Drug|gemcitabine hydrochloride|
16377723|NCT00003426|Radiation|radiation therapy|
16377724|NCT00003414|Biological|aldesleukin|
16377725|NCT00003414|Biological|recombinant interferon gamma|
16377726|NCT00003414|Drug|busulfan|
16377727|NCT00003414|Drug|cyclophosphamide|
16377728|NCT00003414|Drug|cyclosporine|
16377729|NCT00003414|Procedure|peripheral blood stem cell transplantation|
16377730|NCT00003414|Radiation|radiation therapy|
16377731|NCT00003409|Drug|motexafin gadolinium|
16377732|NCT00003409|Radiation|radiation therapy|
16377733|NCT00003388|Biological|filgrastim|
16377734|NCT00003388|Drug|cyclophosphamide|
16377735|NCT00003388|Drug|cytarabine|
16377736|NCT00003388|Drug|methotrexate|
16377737|NCT00003388|Drug|pegylated liposomal doxorubicin hydrochloride|
16377738|NCT00003388|Drug|prednisone|
16377739|NCT00003388|Drug|vincristine sulfate|
16377740|NCT00003388|Radiation|radiation therapy|
16377741|NCT00073593|Drug|Bivalirudin|250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s).
16377742|NCT00073593|Drug|Heparin|: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
16377743|NCT00073593|Drug|Protamine|Per institutional practice. Batches from hospital stock.
16377744|NCT00073580|Drug|Angiomax (bivalirudin) anticoagulant|): 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of the procedure with the option to increase or decrease the infusion rate in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT+) >300 seconds. A low-dose infusion could be administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. An initial dose of 0.1 mg/kg IV bolus followed by an IV infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.
16377745|NCT00073554|Drug|Alfimeprase|
16377746|NCT00073541|Drug|EMD 72000|
16377747|NCT00073528|Drug|Lapatinib|1500 mg orally once a day
16377748|NCT00073528|Drug|Letrozole|2.5 mg orally once a day
16377749|NCT00073528|Drug|Placebo|Placebo (which matched with lapatinib tablet)
16377750|NCT00003387|Drug|carboplatin|
16377751|NCT00003387|Drug|chemotherapy|
16377752|NCT00003387|Drug|paclitaxel|
16377753|NCT00003387|Radiation|radiation therapy|
16377754|NCT00003313|Biological|filgrastim|
16377755|NCT00003313|Drug|amifostine trihydrate|
16377756|NCT00003313|Drug|carboplatin|
16377757|NCT00003313|Drug|paclitaxel|
16377758|NCT00003313|Radiation|radiation therapy|
16377759|NCT00003253|Drug|paclitaxel|
16377760|NCT00003253|Other|antitumor drug screening assay|
16377761|NCT00003202|Drug|cisplatin|
16377762|NCT00003202|Drug|gemcitabine hydrochloride|
16377763|NCT00003202|Radiation|radiation therapy|
16377764|NCT00003191|Drug|fenretinide|
16377765|NCT00073515|Drug|Alfimeprase|
16377766|NCT00073502|Drug|OSI-7904L|
16377767|NCT00073489|Drug|OSI-461|
16377768|NCT00073463|Genetic|tgAAVCF|
16377769|NCT00003167|Biological|Ad5CMV-p53 gene|Given intravesically
16377770|NCT00003130|Drug|paclitaxel|
16377771|NCT00003060|Biological|filgrastim|
16377772|NCT00003060|Drug|busulfan|
16377773|NCT00003060|Drug|cyclophosphamide|
16377774|NCT00003060|Drug|cyclosporine|
16377775|NCT00003060|Drug|methotrexate|
16377776|NCT00003060|Procedure|allogeneic bone marrow transplantation|
16377777|NCT00003037|Drug|cisplatin|
16377778|NCT00003037|Drug|docetaxel|
16377779|NCT00003037|Drug|gemcitabine hydrochloride|
16377780|NCT00002989|Drug|busulfan|
16377781|NCT00002989|Drug|cyclophosphamide|
16377782|NCT00002989|Drug|idarubicin|
16377783|NCT00002989|Drug|melphalan|
16377784|NCT00002989|Radiation|radiation therapy|
16377785|NCT00073476|Drug|traxiprodil (CP-101,606)|
16377786|NCT00073450|Drug|Farnesyl Protein Transferase Inhibitor|
16377787|NCT00073437|Drug|Infliximab|
16377788|NCT00002940|Drug|hydroxyurea|
16377789|NCT00002836|Biological|Filgrastim (G-CSF)|For group one (Filgrastim + Chemotherapy), given under the skin (SC) on day 4 every 12 hours until completion of apheresis; for group two (Filgrastim alone), beginning on day of reinfusion twice a day (bid) until white blood count (WBC) reaches a safe level.
16377790|NCT00002836|Drug|Carmustine|Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days
16377791|NCT00002836|Drug|Cisplatin|As part of CVP chemotherapy treatment by vein (IV) on days 1-3.
16377792|NCT00002836|Drug|Cyclophosphamide (CTX)|In group one (Filgrastim + Chemotherapy) as part of CVP chemotherapy treatment by vein (IV) on days 1-3; and group two (Filgrastim alone), upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
16377793|NCT00002836|Drug|Etoposide|CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.
16377794|NCT00002836|Drug|Thiotepa|Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
16377795|NCT00002836|Procedure|Peripheral Blood Stem Cell Transplantation|Infusion of stem cells on Day 0.
16377796|NCT00002828|Drug|fluorouracil|
16377797|NCT00002828|Drug|raltitrexed|
16377798|NCT00002812|Drug|asparaginase|Given IV
16377799|NCT00002812|Drug|cyclophosphamide|Given IV
16377800|NCT00002812|Drug|cytarabine|Given IV
16377801|NCT00002812|Drug|daunorubicin hydrochloride|Given IV
16377802|NCT00002812|Drug|dexamethasone|Given IV
16377803|NCT00002812|Drug|doxorubicin hydrochloride|Given IV
16377804|NCT00002812|Drug|idarubicin|Given IV
16377805|NCT00002812|Drug|mercaptopurine|Given IV
16377806|NCT00002812|Drug|methotrexate|Given PO
16377807|NCT00002812|Drug|pegaspargase|Given IV
16377808|NCT00002812|Drug|prednisone|Given PO
16377809|NCT00002812|Drug|thioguanine|Given IV
16377810|NCT00002812|Drug|vincristine sulfate|Given IV
16377811|NCT00002812|Radiation|radiation therapy|
16377812|NCT00002761|Biological|filgrastim|
16377813|NCT00002761|Biological|recombinant interferon gamma|
16377814|NCT00002761|Drug|busulfan|
16377815|NCT00002761|Drug|cyclophosphamide|
16377816|NCT00002761|Drug|cyclosporine|
16377817|NCT00002761|Drug|cytarabine|
16377818|NCT00002761|Drug|idarubicin|
16377819|NCT00002761|Procedure|peripheral blood stem cell transplantation|
16377820|NCT00073411|Drug|duloxetine|
16377821|NCT00073411|Drug|escitalopram|
16377822|NCT00073411|Drug|placebo|
16377823|NCT00073385|Drug|Pivanex|
16377824|NCT00073385|Drug|Docetaxel|
16377825|NCT00073372|Drug|Abciximab|
16377826|NCT00073359|Behavioral|Cognitive Behavioral Therapy|
16377908|NCT00072826|Drug|Oxypurinol|
16377828|NCT00073333|Behavioral|Social Skills Training|Social skills training once per week
16377829|NCT00073333|Behavioral|Exposure Treatment|Exposure once per week
16377830|NCT00073333|Behavioral|Placebo|Placebo
16377831|NCT00073320|Drug|Paliperidone Palmitate|
16377832|NCT00073307|Drug|Sorafenib (Nexavar, BAY43-9006)|Multi Kinase Inhibitor
16377833|NCT00073307|Drug|Placebo|Placebo
16377834|NCT00036920|Drug|canfosfamide hydrochloride|
16377835|NCT00027521|Biological|bleomycin sulfate|
16377836|NCT00027521|Drug|electroporation therapy|
16377837|NCT00025532|Other|iodine I 131 monoclonal antibody CC49-deltaCH2|
16377838|NCT00002561|Biological|bleomycin sulfate|10 units/m2
16377839|NCT00002561|Drug|dacarbazine|375mg/m2
16377840|NCT00002561|Drug|doxorubicin hydrochloride|25mg/m2
16377841|NCT00002561|Drug|vinblastine|6mg/m2
16377842|NCT00002561|Radiation|radiation therapy|35Gy in 20 fractions (daily)
16377843|NCT00073398|Biological|Drug: Hyperacute Lung Cancer Cell Vaccine|At dose levels I IV the vaccine cells will be injected intradermally every four weeks for four cycles. Dosage will vary from a total of 3 x 106 to 100 x 106 HyperAcute -Lung Cancer Vaccine cells administered per vaccination cycle. At dose level V patients will receive injections of the HyperAcute -Lung Cancer Vaccine cells to include one (1) initial priming vaccine dose of 500 x 106 cells followed by seven (7) booster vaccine cell doses of 300 x 106 HyperAcute -Lung Cancer cell vaccine cells every two weeks. In Phase II, patients will receive 300 x 106 HyperAcute -Lung Cancer cell vaccine cells every two weeks for a total of 8 doses (4 months).
16377844|NCT00073294|Behavioral|diet|
16377845|NCT00073281|Procedure|Islet transplantation|
16377846|NCT00073255|Drug|hokt3g1 (ALA-ALA)|
16377847|NCT00073268|Behavioral|Exercise|
16377848|NCT00073242|Drug|Leptin|leptin administration
16377849|NCT00073242|Behavioral|Dietary modification|Subjects lose 10% of body weight via dietary restriction
16377850|NCT00073242|Drug|T3 repletion|administer T3
16377851|NCT00073216|Biological|Clade B gag DNA/PLG and env DNA/PLG Microparticles|
16377852|NCT00073216|Biological|Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant|
16377853|NCT00073203|Drug|R228060|
16377854|NCT00073203|Drug|Placebo and Paroxetine|
16377855|NCT00073177|Drug|Roflumilast|
16377856|NCT00073190|Behavioral|Osteoporosis Education|
16377857|NCT00073164|Drug|Divalproex Sodium Extended-Release Tablets|
16377858|NCT00073164|Drug|Olanzapine|
16377859|NCT00073164|Drug|Risperidone|
16377860|NCT00073151|Drug|ABT-751|
16377861|NCT00073138|Drug|ABT-751|
16377862|NCT00073125|Drug|ABT-510/Thrombospondin-1 mimetic|
16377863|NCT00073112|Drug|ABT-751|
16377864|NCT00073047|Drug|Daclizumab|
16377865|NCT00073034|Drug|EAA-090|
16377866|NCT00073073|Drug|Exemestane|exemestane 25 mg by mouth (PO) every day for two years
16377867|NCT00073073|Dietary Supplement|Calcium carbonate|calcium carbonate 1200 mg PO every day x 2 years
16377868|NCT00073073|Dietary Supplement|Vitamin D|Vitamin D 400 international units PO every day x 2 years
16377869|NCT00073021|Drug|Asacol 800 mg (mesalamine)|tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
16377870|NCT00073021|Drug|Asacol 400 mg (mesalamine)|tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
16377871|NCT00073008|Drug|GW572016 (lapatinib)|tyrosine kinase inhibitor
16377872|NCT00072995|Behavioral|Four Diets Differing in Macronutrient Composition|
16377873|NCT00072995|Behavioral|Diets Low in Saturated Fat|
16377874|NCT00072982|Drug|fish oil|The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months.
16377875|NCT00072982|Drug|borage seed oil|Borage oil 13 capsules divided doses daily for 18 months
16377876|NCT00072982|Drug|combination fish oil and borage seed oil|Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
16377877|NCT00072943|Drug|anti-Interferon-gamma monoclonal antibody|
16377878|NCT00072930|Biological|MEDI-522|IV at a concentration of 50 mg/mL and 10mL vials
16377879|NCT00072930|Biological|Docetaxel + Prednisone* + Zoledronic Acid|IV 75 mg/m2 IV 3-4 mg 5 mg
16377880|NCT00072904|Drug|Insulin Asparte|Insulin asparte given 0.5 units per carb per meal
16377881|NCT00072904|Drug|Repaglinide|0.5mg tab with meals tid
16377882|NCT00072891|Behavioral|telephone counseling|
16377883|NCT00072969|Drug|Daclizumab|
16377884|NCT00072865|Drug|Pemetrexed|
16377885|NCT00072865|Drug|Carboplatin|
16377886|NCT00072852|Drug|Irinotecan|
16377887|NCT00072839|Drug|ALX-0600|teduglutide
16377888|NCT00072839|Drug|placebo|placebo solution injected subcutaneously
16377889|NCT00072839|Drug|teduglutide 0.05|0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
16377890|NCT00072839|Drug|teduglutide 0.2 mg|0.2 mg/kg/d subcutaneously injected into thigh or abdomen
16377891|NCT00072839|Drug|Teduglutide 0.05 dose|0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
16377892|NCT00072839|Drug|teduglutide 0.1 mg dose|0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
16377893|NCT00072787|Drug|S-1|
16377894|NCT00072787|Drug|cisplatin|
16377895|NCT00072774|Drug|DVS-233 SR|
16377896|NCT00072761|Procedure|transfusion therapy|Those in the blood transfusion group will receive at least monthly blood transfusion therapy.
16377897|NCT00072748|Drug|EKB-569|
16377898|NCT00072722|Drug|CC-4047|
16377899|NCT00017017|Drug|paclitaxel poliglumex|
16377900|NCT00014677|Biological|interleukin-4 PE38KDEL cytotoxin|
16377901|NCT00014677|Procedure|conventional surgery|
16377902|NCT00014638|Drug|letrozole|
16377903|NCT00014352|Drug|docetaxel|
16377904|NCT00014352|Drug|doxorubicin hydrochloride|
16377905|NCT00014352|Drug|estramustine phosphate sodium|
16377906|NCT00014352|Drug|ketoconazole|
16377907|NCT00014352|Drug|warfarin|
16377912|NCT00072683|Drug|tolvaptan|
16377913|NCT00072670|Drug|Trabectedin|Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m^2) weekly as 3-hour infusion or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.
16377914|NCT00012090|Drug|bicalutamide|
16377915|NCT00012090|Drug|goserelin acetate|
16377916|NCT00010309|Biological|MART-1 antigen|
16377917|NCT00010309|Biological|gp100 antigen|
16377918|NCT00008372|Drug|chloroquinoxaline sulfonamide|
16377919|NCT00006367|Biological|filgrastim|
16377920|NCT00006367|Drug|busulfan|
16377921|NCT00006367|Drug|cytarabine|
16377922|NCT00006367|Drug|idarubicin|
16377923|NCT00006367|Procedure|peripheral blood stem cell transplantation|
16377924|NCT00006224|Drug|gemcitabine hydrochloride|
16377925|NCT00072735|Procedure|Electrocardiogram|
16377926|NCT00072657|Behavioral|Cognitive Behavioral Therapy|The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each.
16377927|NCT00072657|Behavioral|Tai Chi Chih|Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50- to 60-minute biweekly sessions during the 12-week study.
16377928|NCT00072657|Behavioral|Health Education Seminar|Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
16377929|NCT00072631|Drug|Tarceva (Trademark) (erlotinib HCl, OSI-774)|Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
16377930|NCT00072618|Drug|Exisulind|
16377931|NCT00072501|Procedure|breast imaging study|
16377932|NCT00072501|Procedure|comparison of screening methods|
16377933|NCT00072501|Procedure|magnetic resonance imaging|
16377934|NCT00072501|Procedure|radiomammography|
16377935|NCT00072501|Procedure|ultrasound imaging|
16377936|NCT00072488|Procedure|computed tomography|
16377937|NCT00072488|Procedure|magnetic resonance imaging|
16377938|NCT00072488|Procedure|positron emission tomography|
16377939|NCT00072475|Drug|vatalanib|Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
16377940|NCT00072462|Drug|tamoxifen citrate|Tamoxifen 20mg + Anastrozole placebo
16377941|NCT00072462|Drug|Anastrozole|Anastrozole 1mg + Tamoxifen placebo
16377942|NCT00072449|Biological|rituximab|
16377943|NCT00072436|Drug|gemcitabine hydrochloride|Given IV
16377944|NCT00072436|Drug|alvocidib|Given IV
16377945|NCT00072436|Other|pharmacological study|Correlative studies
16377946|NCT00072410|Radiation|yttrium Y 90 monoclonal antibody Hu3S193|
16377947|NCT00072384|Drug|liposomal vincristine sulfate|Given IV
16377948|NCT00072384|Procedure|cryosurgery|Application of extreme cold to destroy abnormal or diseased tissue.
16377949|NCT00072384|Procedure|laser surgery|Surgery using a laser (instead of a scalpel) to cut tissue
16377950|NCT00072384|Drug|carboplatin|Given IV
16377951|NCT00072384|Drug|etoposide|Given IV
16377952|NCT00072384|Biological|filgrastim|Given subcutaneously
16377953|NCT00072358|Biological|anti-GD2 murine IgG3 monoclonal antibody 3F8|The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.
16377954|NCT00072358|Biological|anti-GD2 murine IgG3 monoclonal antibody 3F8|The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.
16377955|NCT00072345|Drug|lomustine|
16377956|NCT00072345|Drug|temozolomide|
16377957|NCT00072345|Drug|thalidomide|
16377958|NCT00072332|Drug|cisplatin|
16377959|NCT00072332|Drug|edotecarin|
16377960|NCT00072319|Biological|filgrastim|
16377961|NCT00072319|Drug|cyclophosphamide|
16377962|NCT00072319|Drug|epirubicin hydrochloride|
16377963|NCT00072319|Drug|paclitaxel|
16377964|NCT00072319|Procedure|adjuvant therapy|
16377965|NCT00072319|Procedure|neoadjuvant therapy|
16377966|NCT00072293|Procedure|Axillary lymph node dissection|Axillary lymph node dissection
16377967|NCT00072293|Procedure|No axillary lymph node dissection|Therapeutic conventional surgery
16377968|NCT00072280|Biological|dactinomycin|Given Slow intravenous (IV) push over 1-5 minutes, dose < 1yr 0.025 mg/kg > or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64
16377969|NCT00072280|Drug|cyclophosphamide|Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.
16377970|NCT00072280|Drug|etoposide|Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg (or to equal 0.4 mg/mL concentration) on days 1-5 of IE cycle.
16377971|NCT00072280|Drug|ifosfamide|Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle
16377972|NCT00072280|Drug|vincristine sulfate|Given IV Push over 1 minute, dose 0.05 mg/kg (max dose 2 mg) on days 1,8,15,22,29,36,43,50,57 and 64
16377973|NCT00072280|Procedure|Conventional Surgery|"Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an envelope of normal tissue should be undertaken at the initial and/or subsequent resections."
16377974|NCT00072280|Biological|MESNA (mercaptoethane sulfonate)|Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.
16377975|NCT00072280|Biological|Filgrastim|Given IV - Only use filgrastim if chemotherapy has been delayed or modified for hematologic toxicity, or if patient experiences a significant life-threatening toxicity due to bone marrow suppression
16377976|NCT00072267|Drug|7-hydroxystaurosporine|
16377977|NCT00072267|Drug|topotecan hydrochloride|
16377978|NCT00072228|Drug|gemcitabine|
16377979|NCT00072228|Drug|soblidotin|
16377980|NCT00072228|Procedure|chemotherapy|
16377981|NCT00072215|Drug|cisplatin|given IV
16377982|NCT00072215|Drug|ifosfamide|given IV
16377983|NCT00072215|Drug|paclitaxel|given IV
16377984|NCT00072215|Drug|vinblastine|given IV
16377985|NCT00072189|Drug|7-hydroxystaurosporine|Given IV
16377986|NCT00072189|Other|laboratory biomarker analysis|Correlative studies
16377987|NCT00072189|Other|pharmacological study|Correlative studies
16377988|NCT00072176|Drug|temsirolimus|Given IV
16377989|NCT00072176|Other|laboratory biomarker analysis|Correlative studies
16377990|NCT00072163|Drug|temozolomide|Given orally
16377991|NCT00072163|Drug|thalidomide|Given orally
16377992|NCT00072150|Drug|bortezomib|Given IV
16377993|NCT00072137|Biological|Recombinant Fowlpox-TRICOM Vaccine|Given intravesically
16377994|NCT00072137|Biological|Recombinant Fowlpox GM-CSF Vaccine Adjuvant|Given intravesically
16377995|NCT00072137|Procedure|Therapeutic Conventional Surgery|Undergo cystectomy
16377996|NCT00072137|Other|Pharmacological Study|Correlative studies
16377997|NCT00072137|Other|Laboratory Biomarker Analysis|Correlative studies
16377998|NCT00072124|Drug|cisplatin|
16377999|NCT00072124|Drug|dacarbazine|
16378000|NCT00072124|Procedure|conventional surgery|
16378001|NCT00072111|Biological|anakinra|
16378002|NCT00072098|Biological|adenovirus vector|
16378003|NCT00072098|Biological|interleukin-12 gene|
16378004|NCT00072085|Biological|aldesleukin|
16378005|NCT00072085|Biological|gp100 antigen|
16378006|NCT00072085|Biological|incomplete Freund's adjuvant|
16378007|NCT00072072|Drug|celecoxib|
16378008|NCT00072072|Drug|erlotinib hydrochloride|
16378009|NCT00072059|Biological|methoxy polyethylene glycol epoetin beta|
16378010|NCT00072046|Biological|bevacizumab|10mg/kg IV infusion on Days 1 & 15 of each cycle
16378011|NCT00072046|Biological|recombinant interferon alfa|9 million units subQ injection 3 x/week for 4 weeks
16378012|NCT00072033|Drug|Cisplatin and Docetaxel|cisplatin and docetaxel chemo- and radiochemotherapy
16378013|NCT00072020|Drug|zoledronic acid|
16378014|NCT00072020|Procedure|adjuvant therapy|
16378015|NCT00072020|Procedure|neoadjuvant therapy|
16378016|NCT00072007|Biological|filgrastim|filgrastim
16378017|NCT00072007|Biological|rituximab|rituximab
16378018|NCT00072007|Drug|CHOP regimen|CHOP regimen
16378019|NCT00072007|Drug|cladribine|cladribine
16378020|NCT00072007|Drug|cyclophosphamide|cyclophosphamide
16378021|NCT00072007|Drug|doxorubicin hydrochloride|doxorubicin hydrochloride
16378022|NCT00072007|Drug|prednisone|prednisone
16378023|NCT00072007|Drug|vincristine sulfate|vincristine sulfate
16378024|NCT00071994|Drug|gefitinib|Given orally
16378025|NCT00071994|Other|laboratory biomarker analysis|Correlative studies
16378026|NCT00071981|Biological|incomplete Freund's adjuvant|Given by injection
16378027|NCT00071981|Biological|melanoma helper peptide vaccine|Given by injection
16378028|NCT00071981|Biological|multi-epitope melanoma peptide vaccine|Given by injection
16378029|NCT00071981|Biological|sargramostim|Given by injection
16378030|NCT00071981|Biological|tetanus peptide melanoma vaccine|Given by injection
16378031|NCT00071968|Drug|temsirolimus|
16378032|NCT00071968|Procedure|conventional surgery|
16378033|NCT00071968|Procedure|neoadjuvant therapy|
16378034|NCT00071955|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16378035|NCT00071955|Biological|sargramostim|
16378036|NCT00071942|Biological|recombinant vaccinia-MUC1 vaccine|Given intradermally
16378037|NCT00071942|Biological|recombinant vaccinia-TRICOM vaccine|Given intradermally
16378038|NCT00071942|Other|laboratory biomarker analysis|Correlative studies
16378039|NCT00071942|Procedure|quality-of-life assessment|Ancillary studies
16378040|NCT00071929|Drug|oxaliplatin|
16378041|NCT00003141|Biological|filgrastim|Given IV
16378042|NCT00003141|Drug|carboplatin|Given IV
16378043|NCT00003141|Drug|cisplatin|Given IV
16378044|NCT00003141|Drug|cyclophosphamide|Given IV
16378045|NCT00003141|Drug|etoposide|Given IV
16378046|NCT00003141|Drug|thiotepa|Given IV
16378047|NCT00003141|Drug|vincristine sulfate|Given IV
16378048|NCT00003141|Procedure|conventional surgery|
16378049|NCT00003141|Procedure|peripheral blood stem cell transplantation|
16378050|NCT00072605|Drug|VRC-EBODNA012-00-VP|
16378051|NCT00072592|Drug|Rituximab|
16378052|NCT00072579|Biological|sargramostim|
16378053|NCT00072566|Biological|Bevacizumab|Given IV
16378054|NCT00072566|Drug|Cyclophosphamide|Given PO
16378055|NCT00072566|Other|Laboratory Biomarker Analysis|Correlative studies
16378056|NCT00072553|Drug|celecoxib|
16378057|NCT00072553|Drug|fluorouracil|
16378058|NCT00072553|Drug|leucovorin calcium|
16378059|NCT00072553|Drug|oxaliplatin|
16378060|NCT00072553|Procedure|adjuvant therapy|
16380268|NCT00060931|Drug|carvedilol|
16378061|NCT00072553|Procedure|conventional surgery|
16378062|NCT00072553|Procedure|neoadjuvant therapy|
16378063|NCT00072540|Drug|celecoxib|
16378064|NCT00072540|Procedure|anti-cytokine therapy|
16378065|NCT00072540|Procedure|antiangiogenesis therapy|
16378066|NCT00072540|Procedure|biological therapy|
16378067|NCT00072540|Procedure|cancer prevention intervention|
16378068|NCT00072540|Procedure|chemoprevention of cancer|
16378069|NCT00072540|Procedure|enzyme inhibitor therapy|
16378070|NCT00072540|Procedure|growth factor antagonist therapy|
16378071|NCT00072527|Drug|carboplatin|IV
16378072|NCT00072527|Drug|cisplatin|IV
16378073|NCT00072527|Drug|etoposide|IV
16378074|NCT00072527|Drug|irinotecan hydrochloride|IV
16378075|NCT00072527|Radiation|radiation therapy|
16378076|NCT00072514|Drug|gemcitabine hydrochloride|Given IV
16378077|NCT00072514|Drug|carboplatin|Given IV
16378078|NCT00072514|Drug|dexamethasone|Given PO
16378079|NCT00072514|Biological|rituximab|Given IV in CD20-POSITIVE LYMPHOMAS cases
16378080|NCT00071851|Biological|VRC-HIVDNA009-00-VP|
16378081|NCT00071812|Drug|Placebo|Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
16378082|NCT00071812|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
16378083|NCT00071812|Drug|Belimumab 4 mg/kg|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
16378084|NCT00071812|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.
16378085|NCT00071799|Drug|Azacitidine|Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
16378086|NCT00071799|Other|Physician Choice|"Physician Choice was one of three options:
~Best supportive care (BSC) alone,
~Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
~Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).
~All three options included best supportive care"
16378087|NCT00006008|Drug|arsenic trioxide|
16378088|NCT00005964|Biological|filgrastim|
16378089|NCT00005964|Drug|cyclophosphamide|
16378090|NCT00005964|Drug|doxorubicin hydrochloride|
16378091|NCT00005964|Drug|etoposide|
16378092|NCT00005964|Drug|prednisone|
16378093|NCT00005964|Drug|vincristine sulfate|
16378094|NCT00005962|Biological|sargramostim|
16378095|NCT00005962|Drug|cyclophosphamide|
16378096|NCT00005962|Drug|cytarabine|
16378097|NCT00005962|Drug|gemtuzumab ozogamicin|
16378098|NCT00005962|Drug|liposomal daunorubicin citrate|
16378099|NCT00005962|Drug|topotecan hydrochloride|
16378100|NCT00005576|Biological|monoclonal antibody Ch14.18|Given IV
16378101|NCT00005576|Drug|isotretinoin|Given orally
16378102|NCT00005576|Biological|aldesleukin|Given IV
16378103|NCT00005576|Biological|sargramostim|Given IV
16378104|NCT00005094|Drug|celecoxib|Given orally
16378105|NCT00005094|Other|placebo|Given orally
16378106|NCT00071890|Drug|Interleukin 2|Three cycles of IL-2 (6 MUI bid during 5 days = one cycle)
16378107|NCT00071890|Drug|HAART|HAART from week 0 to week 24
16378108|NCT00071890|Drug|Treatment interruption|HAART is interrupted from week 24 in both arms
16378109|NCT00071877|Drug|Replagal|
16378110|NCT00005072|Biological|Leuvectin|1000 ug of Leuvectin injected intratumorally
16378111|NCT00005046|Drug|chemotherapy|
16378112|NCT00005046|Drug|paclitaxel|
16378113|NCT00004206|Drug|FOLFOX regimen|
16378114|NCT00004206|Drug|fluorouracil|
16378115|NCT00004206|Drug|leucovorin calcium|
16378116|NCT00004206|Drug|oxaliplatin|
16378117|NCT00004093|Drug|carboplatin|Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
16378118|NCT00004093|Drug|Gemcitabine|Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
16378119|NCT00004093|Drug|paclitaxel|Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
16378120|NCT00004093|Drug|vinorelbine|Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
16378121|NCT00004093|Radiation|radiation therapy|Radiation will be given at a dose ranging between 45 to 66 Gy, depending on patient-specific characteristics.
16378122|NCT00004093|Drug|Navelbine|Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
16380269|NCT00060931|Drug|metoprolol|
16378123|NCT00004093|Drug|Taxol|Taxol will be administered at a dose of 50 mg/m2 in 250 cc of NS or D5W over 60 minutes, following Navelbine (one dose weekly during radiation therapy)
16378124|NCT00071838|Drug|Daclizumab|
16378125|NCT00071773|Procedure|modified-ETDRS photocoagulation|A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
16378126|NCT00071773|Procedure|Mild Macular Grid photocoagulation|A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
16378127|NCT00071760|Drug|GW433908|Fosamprenavir suspension bid
16378128|NCT00071760|Drug|ritonavir|Ritonavir solution bid
16378129|NCT00071747|Drug|lamotrigine|
16378130|NCT00071721|Drug|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
16378131|NCT00071721|Drug|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
16378133|NCT00071695|Drug|Duloxetine Hydrochloride|
16378134|NCT00071695|Drug|Venlafaxine Extended Release|
16378135|NCT00071669|Procedure|Acupuncture|
16378136|NCT00071656|Behavioral|Psychosocial (behavioral) Intervention|
16378137|NCT00071643|Behavioral|Problem Solving Therapy|Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
16378138|NCT00071643|Drug|Escitalopram|Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
16378139|NCT00071643|Other|Placebo|Participants will receive a placebo pill.
16378140|NCT00071630|Behavioral|Cognitive Behavioral Therapy|
16378141|NCT00071617|Behavioral|Youth-Nominated Support Team|
16378142|NCT00071604|Behavioral|Medication Adherence Therapy|
16378143|NCT00071604|Behavioral|Friendly Support Group|
16378144|NCT00071591|Behavioral|Functional Adaptation Skills Training (FAST)|
16378145|NCT00071578|Behavioral|Group Psychotherapy-Negative Emotion Focus|20 weekly sessions, 2 hours, group format
16378146|NCT00071578|Behavioral|Group Psychotherapy- Self-Esteem Focus|20 weekly sessions, 2 hours, group format
16378147|NCT00071552|Drug|Qvar|Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks
16378148|NCT00071552|Drug|Flovent Diskus|Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks
16378149|NCT00071539|Drug|TP-38|Recombinant chimeric protein
16378150|NCT00071539|Drug|TP38|recombinant chimeric protein
16378151|NCT00004074|Biological|recombinant interleukin-12|Given IV
16378152|NCT00004074|Biological|ABI-007/carboplatin/trastuzumab|Given IV
16378153|NCT00004050|Biological|Leuvectin|Leuvectin injected intratumorally followed by prostatectomy
16378154|NCT00004025|Biological|aldesleukin|
16378155|NCT00004025|Biological|dendritic cell-gp100-MART-1 antigen vaccine|
16378156|NCT00003794|Procedure|psychosocial assessment and care|
16378157|NCT00003794|Procedure|quality-of-life assessment|
16378158|NCT00003648|Genetic|DNA stability analysis|
16378159|NCT00003648|Genetic|gene rearrangement analysis|
16378160|NCT00071513|Behavioral|CAST-T/HSTS|Skills training small group.
16378161|NCT00071513|Behavioral|Brief Intervention|Assessment of needs and referral to services as needed.
16378162|NCT00071500|Device|MedSignals™|An electronic device that is used to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions.
16378163|NCT00071487|Drug|Placebo|Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
16378164|NCT00071487|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
16378165|NCT00071487|Drug|Belimumab 4 mg/kg|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
16378166|NCT00071487|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
16378167|NCT00003595|Biological|filgrastim|
16378168|NCT00003595|Biological|rituximab|
16378169|NCT00003595|Drug|CHOP regimen|
16378170|NCT00003595|Drug|cyclophosphamide|
16378171|NCT00003595|Drug|doxorubicin hydrochloride|
16378172|NCT00003595|Drug|prednisone|
16378173|NCT00003595|Drug|vincristine sulfate|
16378174|NCT00003266|Drug|methylphenidate hydrochloride|
16378175|NCT00003266|Procedure|quality-of-life assessment|
16378176|NCT00003234|Drug|vinorelbine tartrate|
16378177|NCT00003190|Drug|cytarabine|Given IV
16378178|NCT00003190|Drug|daunorubicin hydrochloride|Given IV
16378179|NCT00003190|Drug|etoposide|Given IV
16378180|NCT00003190|Drug|valspodar|Given IV
16378181|NCT00003126|Drug|Interleukin-2|High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
16378182|NCT00071474|Procedure|shamanic healing|
16378183|NCT00071461|Drug|bosentan|"Initial dose: 62.5 mg b.i.d. for 4 weeks.
~Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).
~body weight < 40 kg (90 lb): 62.5 mg b.i.d."
16378184|NCT00071461|Drug|Placebo|"Initial dose: 62.5 mg b.i.d. for 4 weeks.
~Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated).
~body weight < 40 kg (90 lb): 62.5 mg b.i.d."
16378185|NCT00071448|Drug|insulin human|
16378186|NCT00071448|Drug|insulin lispro|
16378187|NCT00071448|Drug|insulin aspart|
16378188|NCT00071422|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
16378189|NCT00071422|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
16378190|NCT00071422|Drug|placebo|1.5 mL, once daily, self-administered SC injection for 90 days
16378191|NCT00071409|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
16378192|NCT00071409|Drug|INGAP-Peptide|1.5 mL, once daily, self-administered SC injection for 90 days
16378193|NCT00071409|Drug|placebo|1.5 mL, once daily, self-administered SC injection for 90 days
16378194|NCT00071396|Drug|Campath-1H|15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
16378195|NCT00071396|Drug|Rituximab|375 mg/m^2 IV infusion on day 1, then 500 mg/m^2 on days 8, 15, and 22.
16378196|NCT00033527|Drug|INS316|
16378197|NCT00033527|Other|sputum cytology|
16378198|NCT00025350|Drug|gefitinib|
16378199|NCT00003077|Dietary Supplement|omega-3 fatty acid|
16378200|NCT00002935|Drug|porfimer sodium|
16378201|NCT00002723|Drug|suramin|3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
16378202|NCT00002723|Drug|suramin|5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
16378203|NCT00002723|Drug|Suramin|7.661 g/square meter toal dose given in decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,5,58,64,and 65.
16378204|NCT00071331|Drug|Tolvaptan|
16378205|NCT00071292|Behavioral|stress reduction program|
16378206|NCT00071292|Behavioral|meditation|
16378207|NCT00030420|Drug|Celecoxib|400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
16378208|NCT00030420|Drug|Docetaxel|On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
16378209|NCT00026260|Drug|semaxanib|
16378210|NCT00024206|Drug|orantinib|Given orally
16378211|NCT00024206|Other|laboratory biomarker analysis|Correlative studies
16378212|NCT00024206|Other|pharmacological study|Correlative studies
16378213|NCT00024128|Biological|anti-thymocyte globulin|
16378214|NCT00024128|Biological|therapeutic allogeneic lymphocytes|
16378215|NCT00024128|Drug|cyclophosphamide|
16378216|NCT00024128|Drug|cyclosporine|
16378217|NCT00024128|Procedure|peripheral blood stem cell transplantation|
16378218|NCT00024128|Radiation|radiation therapy|
16378219|NCT00023738|Biological|filgrastim|
16378220|NCT00023738|Drug|dacarbazine|
16378221|NCT00023738|Drug|doxorubicin hydrochloride|
16378222|NCT00023738|Drug|ifosfamide|
16378223|NCT00023738|Drug|semaxanib|
16378224|NCT00023738|Procedure|conventional surgery|
16378225|NCT00023738|Radiation|radiation therapy|
16378226|NCT00071279|Drug|SR34006 (idraparinux sodium) Injection|
16378227|NCT00071266|Drug|Niacin Extended Release and Lovastatin Tablets|
16378228|NCT00071253|Drug|Divalproex Sodium (Delayed-Release Tablets)|
16378229|NCT00071253|Drug|Divalproex Sodium (Extended-Release Tablets)|
16378230|NCT00071253|Drug|Olanzapine|
16378231|NCT00071240|Drug|Somatropin (recombinant human growth hormone)|3.0mg sc daily for 6 months, followed by 1.5mg sc daily for 6 months. Dose stopped, held or reduced by study investigators as indicated by adverse events
16378232|NCT00071214|Biological|S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine|
16378233|NCT00071201|Drug|Adefovir Dipivoxil for oral suspension, 2 mg/mL|
16378234|NCT00064428|Drug|fondaparinux - UFH not indicated|2.5mg od, sc (1st dose IV) x 8 days or discharge
16378235|NCT00064428|Other|Control - UFH not indicated|Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
16378236|NCT00064428|Drug|Fondaparinux - UFH indicated|2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
16378237|NCT00064428|Drug|Control - UFH|UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
16378238|NCT00071227|Drug|Triamcinolone Acetonide (TAC-PF)|
16378239|NCT00071188|Drug|ZD6474|
16378240|NCT00071188|Drug|Paclitaxel|
16378241|NCT00071188|Drug|Carboplatin|
16378242|NCT00071136|Drug|pemetrexed|
16378243|NCT00071136|Drug|gemcitabine|
16378244|NCT00071110|Procedure|Electroacupuncture|For subjects randomized to EA, needles were placed at points GV-20-on the crown of the head and yin tang-on the midline of the forehead roughly at the glabella and treated with electrical stimulation. 30 mm x 0.22 mm sterile stainless steel needles were placed obliquely to a depth of approximately 10 mm and were connected to face-microelectrodes which were connected to the Pantheon Research PENS-Electrostimulator. Electricity was provided at a frequency of 2 Hz and set to a voltage which resulted in the perception of a mild intensity stimulation.
16378245|NCT00071110|Procedure|Sham|For subjects randomized to SA, two needles were placed laterally on the scalp, 3 cuns superior to the temporal attachment of the helix of the ear. This point was selected as it does not correspond to any specific meridian acupuncture point. A disabled electrical cable was connected to the needles and the electrostimulator, with light blinking at 2 Hz but no electrical stimulation provided.
16378246|NCT00071097|Drug|TMC114/rtv|800mg TMC114/100mg rtv once daily
16378247|NCT00071097|Drug|TMC114/rtv|400mg TMC114/100mg rtv both twice daily
16378248|NCT00071097|Drug|TMC114/rtv|400mg TMC114/100mg rtv once daily
16380270|NCT00060918|Drug|carvedilol|
16378249|NCT00071097|Drug|TMC114/rtv|600mg TMC114/100mg rtv twice daily
16378250|NCT00071084|Drug|HuMax-CD4|
16378251|NCT00071071|Drug|HuMax-CD4|
16378252|NCT00025467|Drug|thalidomide|Given orally
16378253|NCT00025467|Other|laboratory biomarker analysis|Correlative studies
16378254|NCT00023725|Drug|semaxanib|
16378255|NCT00023725|Procedure|conventional surgery|
16378256|NCT00023725|Radiation|radiation therapy|
16378257|NCT00023699|Drug|gefitinib|
16378258|NCT00022282|Drug|shark cartilage extract AE-941|
16378259|NCT00016250|Drug|MKC-1|
16378260|NCT00015912|Biological|recombinant interferon alfa|Given IV
16378261|NCT00015912|Drug|thalidomide|Given orally
16378262|NCT00015912|Other|laboratory biomarker analysis|Correlative studies
16378263|NCT00015886|Drug|docetaxel|75 milligrams per meter squared intraveneously
16378264|NCT00015886|Drug|fluorouracil|350 milligrams intraveneously
16378265|NCT00014144|Drug|gefitinib|
16378266|NCT00007917|Drug|alvocidib|
16378267|NCT00007917|Drug|gemcitabine hydrochloride|
16378268|NCT00071032|Biological|Liberal (10 g/dL) Transfusion Strategy|This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.
16378269|NCT00071032|Biological|Restrictive (Symptomatic) Transfusion Strategy|Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.
16378270|NCT00071006|Drug|AG-013736 (Axitinib)|patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.
16378271|NCT00070993|Drug|creatine monohydrate|
16378272|NCT00070980|Procedure|Massage therapy|
16378273|NCT00070967|Procedure|Acupuncture|
16378274|NCT00070954|Drug|ginkgo biloba|EgB 761
16378275|NCT00070954|Other|matched placebo|Inactive look-alike placebo
16378276|NCT00070941|Drug|SAM-e|oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
16378277|NCT00070941|Drug|oral escitalopram|20mg or 30mg daily in two divided doses, along with placebo SAM-e.
16378278|NCT00070941|Drug|placebo|oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
16378279|NCT00070928|Drug|valerian|
16378280|NCT00070915|Behavioral|Tai chi|
16378281|NCT00070915|Behavioral|Mindfulness-based Stress Reduction program|
16378282|NCT00070915|Procedure|Therapeutic massage|
16378283|NCT00070902|Procedure|Lumbar side-posture spinal adjusting|
16378284|NCT00070837|Drug|MLN2704 (DM1 conjugated monoclonal antibody MLN591)|
16378285|NCT00070824|Procedure|acupuncture|
16378286|NCT00070811|Procedure|Lip revision surgery|Full or partial muscle thickness lip revision surgery.
16378287|NCT00070720|Behavioral|Opinion Leaders, Academic Detailing, Reminders, and Feedback|
16378288|NCT00071058|Drug|XR9576 (Tariquidar)|
16378289|NCT00070733|Drug|testosterone enanthate|
16378290|NCT00070733|Drug|duastride|
16378291|NCT00070707|Drug|Mometasone|Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
16378292|NCT00070707|Drug|Placebo|Matching placebo nasal spray, administered QD as 2 sprays in each nostril.
16378293|NCT00070707|Drug|Albuterol/Salbutamol|Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
16378294|NCT00070876|Behavioral|Mental health communication skills training|
16378295|NCT00070863|Behavioral|Individual Cognitive Behavioral Therapy|
16378296|NCT00070681|Procedure|Polysomnography|
16378297|NCT00070655|Drug|SR34006 (idraparinux sodium) Injection|
16378298|NCT00070655|Drug|vitamin K antagonist (warfarin or acenocoumarol) tablets|
16378299|NCT00069433|Procedure|Social skills and symptom management training|
16378300|NCT00021099|Drug|ixabepilone|Given IV
16378301|NCT00017368|Biological|filgrastim|
16378302|NCT00017368|Biological|sargramostim|
16378303|NCT00017368|Drug|carboplatin|
16378304|NCT00017368|Drug|cisplatin|
16378305|NCT00017368|Drug|cyclophosphamide|
16378306|NCT00017368|Drug|doxorubicin hydrochloride|
16378307|NCT00017368|Drug|etoposide|
16378308|NCT00017368|Drug|etoposide phosphate|
16378309|NCT00017368|Drug|ifosfamide|
16378310|NCT00017368|Drug|isotretinoin|
16378311|NCT00017368|Drug|melphalan|
16378312|NCT00017368|Drug|thiotepa|
16378313|NCT00017368|Drug|vincristine sulfate|
16378314|NCT00017368|Procedure|conventional surgery|
16378315|NCT00017368|Procedure|peripheral blood stem cell transplantation|
16378316|NCT00017368|Radiation|radiation therapy|
16378317|NCT00003907|Drug|cisplatin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
16378318|NCT00003907|Drug|doxorubicin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
16378319|NCT00003907|Drug|mitomycin|Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
16378320|NCT00003907|Procedure|embolization|Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
16378321|NCT00070759|Drug|Daclizumab|
16378322|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
16378323|NCT00070642|Drug|dacarbazine|dacarbazine 850mg/m2 in three-week cycles until disease progression
16378407|NCT00070317|Drug|Isosulfan Blue|Undergo lymphangiography using isosulfan blue or methylene blue
16378324|NCT00070642|Drug|Chemotherapy|"Chemotherapy in three-week cycles until disease progression:
~dacarbazine 850mg/m2"
16378325|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
16378326|NCT00070642|Drug|CPG 7909 Injection|CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
16378327|NCT00070629|Drug|CPG 7909|CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
16378328|NCT00070629|Drug|Chemotherapy|"A taxane and a platinum compound given on week one of three-week cycles:
~Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6"
16378329|NCT00070629|Drug|Chemotherapy|"A taxane and a platinum compound given on week one of three-week cycles:
~Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6"
16378330|NCT00070616|Drug|Palifermin 6 x 60 μg/kg/day|
16378331|NCT00070616|Drug|Palifermin 2 x 180 μg/kg/day|
16378332|NCT00070616|Radiation|radiotherapy|
16378333|NCT00070616|Drug|Chemotherapy|
16378334|NCT00070590|Drug|Bosentan|
16378335|NCT00007839|Drug|beta alethine|
16378336|NCT00006482|Drug|cisplatin|
16378337|NCT00006482|Drug|gemcitabine hydrochloride|
16378338|NCT00006466|Drug|beta alethine|
16378339|NCT00006257|Drug|paclitaxel|
16378340|NCT00006257|Drug|semaxanib|
16378341|NCT00006121|Drug|oxaliplatin|
16378342|NCT00006012|Biological|filgrastim|
16378343|NCT00006012|Drug|amifostine trihydrate|
16378344|NCT00006012|Drug|cisplatin|
16378345|NCT00006012|Drug|etoposide|
16378346|NCT00006012|Drug|paclitaxel|
16378347|NCT00006012|Drug|topotecan hydrochloride|
16378348|NCT00006012|Radiation|radiation therapy|
16378349|NCT00006009|Biological|visilizumab|
16378350|NCT00005998|Drug|carmustine|
16378351|NCT00005998|Drug|cyclophosphamide|
16378352|NCT00005998|Drug|cytarabine|
16378353|NCT00005998|Drug|dexamethasone|
16378354|NCT00005998|Drug|etoposide|
16378355|NCT00005998|Drug|filgrastim|
16378356|NCT00005998|Drug|mitoxantrone hydrochloride|
16378357|NCT00005998|Drug|retrovirus vector LN|
16378358|NCT00005998|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16378359|NCT00005998|Procedure|peripheral blood stem cell transplantation|
16378360|NCT00005998|Procedure|radiation therapy|
16378361|NCT00005800|Biological|Filgrastim|
16378362|NCT00005800|Drug|Docetaxel|
16378363|NCT00005800|Drug|Doxorubicin|
16378364|NCT00005800|Procedure|Surgery|Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.
16378365|NCT00005794|Drug|perifosine|
16378366|NCT00070694|Drug|MDL100.907|
16378367|NCT00070564|Biological|pegfilgrastim|Given IV
16378368|NCT00070564|Drug|AC regimen|Given IV
16378369|NCT00070564|Drug|cyclophosphamide|Given IV
16378370|NCT00070564|Drug|doxorubicin hydrochloride|Given IV
16378371|NCT00070564|Drug|paclitaxel|Given IV
16378372|NCT00070551|Biological|GTI-2040|Given IV
16378373|NCT00070551|Drug|cytarabine|Given IV
16378374|NCT00070551|Other|pharmacological study|Optional correlative studies
16378375|NCT00070551|Other|laboratory biomarker analysis|Optional correlative studies
16378376|NCT00070538|Drug|cytarabine|
16378377|NCT00070538|Drug|laromustine|
16378378|NCT00070525|Drug|tipifarnib|Given orally
16378379|NCT00070499|Drug|Dasatinib|Given PO
16378380|NCT00070499|Drug|Imatinib Mesylate|Given PO
16378381|NCT00070499|Other|Laboratory Biomarker Analysis|Correlative studies
16378382|NCT00070486|Drug|carboplatin|given IV
16378383|NCT00070486|Drug|celecoxib|given PO
16378384|NCT00070486|Drug|gemcitabine hydrochloride|given IV
16378385|NCT00070486|Drug|zileuton|given PO
16378386|NCT00070473|Drug|pemetrexed disodium|
16378387|NCT00070447|Biological|rituximab|
16378388|NCT00070447|Drug|cyclophosphamide|
16378389|NCT00070447|Drug|doxorubicin hydrochloride|
16378390|NCT00070447|Drug|prednisone|
16378391|NCT00070447|Drug|vincristine sulfate|
16378392|NCT00070447|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16378393|NCT00070434|Drug|capecitabine|825mg/m2 BID, PO, daily
16378394|NCT00070434|Drug|fluorouracil|Bolus + IV for 46 hrs on Day 1
16378395|NCT00070434|Drug|irinotecan hydrochloride|IV infusion over 90 min on Day 1
16378396|NCT00070434|Drug|leucovorin calcium|200mg/m2 IV 2 hour infusion on Day 1
16378397|NCT00070434|Drug|oxaliplatin|85mg/m2 IV infusion for 90minutes on Day 1
16378398|NCT00070434|Radiation|radiation therapy|Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.
16378399|NCT00070434|Drug|Pyridoxine|50mg TID, PO daily
16378400|NCT00070421|Procedure|complementary or alternative medicine procedure|
16378401|NCT00070421|Procedure|management of therapy complications|
16378402|NCT00070421|Procedure|psychosocial assessment and care|
16378403|NCT00070382|Drug|darbepoetin alfa|darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
16378404|NCT00070382|Drug|epoetin alfa|epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
16378405|NCT00070343|Biological|oblimersen sodium|
16378406|NCT00070343|Drug|dacarbazine|
16378408|NCT00070317|Procedure|Lymph Node Mapping|Undergo lymphatic mapping
16378409|NCT00070317|Procedure|Lymphangiography|Undergo lymphangiography using isosulfan blue or methylene blue
16378410|NCT00070317|Drug|Methylene Blue|Undergo lymphangiography using isosulfan blue or methylene blue
16378411|NCT00070317|Procedure|Radionuclide Imaging|Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
16378412|NCT00070317|Procedure|Sentinel Lymph Node Biopsy|Undergo complete pelvic and low para-aortic lymphadenectomy
16378413|NCT00070317|Radiation|Technetium Tc-99m Sulfur Colloid|Undergo radionuclide imaging with technetium Tc 99m sulfur colloid
16378414|NCT00070317|Procedure|Therapeutic Conventional Surgery|Undergo radical hysterectomy
16378415|NCT00070304|Biological|filgrastim|Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.
16378416|NCT00070304|Drug|gemcitabine hydrochloride|Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8
16378417|NCT00070304|Drug|vinorelbine tartrate|Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8
16378418|NCT00070291|Drug|cyclosporine|Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
16378419|NCT00070278|Drug|cyclophosphamide|
16378420|NCT00070278|Drug|epirubicin hydrochloride|
16378421|NCT00070278|Drug|gemcitabine hydrochloride|
16378422|NCT00070278|Drug|paclitaxel|
16378423|NCT00070278|Genetic|comparative genomic hybridization|
16378424|NCT00070278|Genetic|microarray analysis|
16378425|NCT00070278|Genetic|mutation analysis|
16378426|NCT00070278|Procedure|conventional surgery|
16378427|NCT00070278|Procedure|neoadjuvant therapy|
16378428|NCT00070265|Drug|oxaliplatin|Given IV
16378429|NCT00070265|Drug|capecitabine|Given orally
16378430|NCT00070265|Procedure|therapeutic conventional surgery|Undergo surgical resection
16378431|NCT00070265|Other|laboratory biomarker analysis|Correlative studies
16378432|NCT00070252|Drug|Capecitabine|Given PO
16378433|NCT00070252|Drug|Docetaxel|Given IV
16378434|NCT00070252|Other|Laboratory Biomarker Analysis|Correlative studies
16378435|NCT00070252|Other|Pharmacological Study|Correlative studies
16378436|NCT00070252|Drug|Tipifarnib|Given orally (PO)
16378437|NCT00070239|Drug|alvocidib|Given IV
16378438|NCT00070239|Other|pharmacological study|Correlative studies
16378439|NCT00070239|Radiation|fludeoxyglucose F 18|Correlative studies
16378440|NCT00070239|Other|fluorine F 18 fluorothymidine|Correlative studies
16378441|NCT00070239|Procedure|positron emission tomography|Correlative studies
16378442|NCT00070213|Drug|FOLFOX regimen|
16378443|NCT00070213|Drug|capecitabine|
16378444|NCT00070213|Drug|fluorouracil|
16378445|NCT00070213|Drug|leucovorin calcium|
16378446|NCT00070213|Drug|oxaliplatin|
16378447|NCT00070213|Procedure|quality-of-life assessment|
16378448|NCT00070200|Biological|filgrastim|
16378449|NCT00070200|Drug|cisplatin|
16378450|NCT00070200|Drug|cyclophosphamide|
16378451|NCT00070200|Drug|doxorubicin hydrochloride|
16378452|NCT00070200|Drug|etoposide|
16378453|NCT00070200|Drug|isotretinoin|
16378454|NCT00070200|Drug|melphalan|
16378455|NCT00070200|Drug|topotecan hydrochloride|
16378456|NCT00070200|Drug|vincristine sulfate|
16378457|NCT00070200|Procedure|conventional surgery|
16378458|NCT00070200|Procedure|peripheral blood stem cell transplantation|
16378459|NCT00070200|Radiation|radiation therapy|
16378460|NCT00070187|Biological|aldesleukin|Given IV
16378461|NCT00070187|Biological|filgrastim|Given IV
16378462|NCT00070187|Biological|recombinant interferon gamma|Given IV
16378463|NCT00070187|Drug|carmustine|Given IV
16378464|NCT00070187|Drug|cyclosporine|Given IV
16378465|NCT00070187|Drug|cytarabine|Given IV
16378466|NCT00070187|Drug|etoposide|Given IV
16378467|NCT00070187|Drug|melphalan|Given IV
16378468|NCT00070187|Procedure|autologous bone marrow transplantation|
16378469|NCT00070187|Procedure|bone marrow ablation with stem cell support|
16378470|NCT00070187|Procedure|peripheral blood stem cell transplantation|
16378471|NCT00070174|Drug|asparaginase|
16378472|NCT00070174|Drug|busulfan|
16378473|NCT00070174|Drug|cyclophosphamide|
16378474|NCT00070174|Drug|cyclosporine|
16378475|NCT00070174|Drug|cytarabine|
16378476|NCT00070174|Drug|daunorubicin hydrochloride|
16378477|NCT00070174|Drug|etoposide|
16378478|NCT00070174|Drug|gemtuzumab ozogamicin|
16378479|NCT00070174|Drug|methotrexate|
16378480|NCT00070174|Drug|mitoxantrone hydrochloride|
16378481|NCT00070174|Procedure|allogeneic bone marrow transplantation|
16378482|NCT00070161|Dietary Supplement|EGb761|
16378483|NCT00070161|Drug|donepezil hydrochloride|
16378484|NCT00070161|Procedure|cognitive assessment|
16378485|NCT00070148|Drug|Megestrol Acetate|Megace by mouth for 12 weeks
16378486|NCT00070148|Drug|Oxandrolone 20 mg|20 mg/day for 3 months (12 weeks)
16378487|NCT00070135|Biological|filgrastim|Given SC
16378488|NCT00070135|Biological|Anti-Thymocyte Globulin|Given IV
16378489|NCT00070135|Drug|busulfan|Given IV
16378490|NCT00070135|Drug|fludarabine phosphate|Given IV
16378491|NCT00070135|Drug|methotrexate|Given IV
16378492|NCT00070135|Drug|tacrolimus|Given PO or IV
16378493|NCT00070135|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC transplantation
16378494|NCT00070122|Drug|oxaliplatin|Given IV
16378495|NCT00070122|Drug|leucovorin calcium|Given IV
16378496|NCT00070122|Drug|capecitabine|Given orally
16378497|NCT00070122|Biological|bevacizumab|Given IV
16378498|NCT00070122|Drug|fluorouracil|Given IV
16378499|NCT00070122|Other|laboratory biomarker analysis|Correlative studies
16378500|NCT00070109|Drug|trabectedin|Given IV
16378501|NCT00070109|Other|pharmacological study|Correlative studies
16378502|NCT00070096|Drug|ixabepilone|
16378503|NCT00070083|Biological|oblimersen sodium|
16378504|NCT00070083|Biological|rituximab|
16378505|NCT00070083|Drug|cyclophosphamide|
16378506|NCT00070083|Drug|doxorubicin hydrochloride|
16378507|NCT00070083|Drug|prednisone|
16378508|NCT00070083|Drug|vincristine sulfate|
16378509|NCT00070070|Biological|TICE®-strain BCG|
16378510|NCT00070070|Biological|NY-ESO-1 protein|
16378511|NCT00070070|Biological|sargramostim|
16378512|NCT00070057|Drug|celecoxib|Given orally
16378513|NCT00070057|Procedure|therapeutic conventional surgery|Undergo surgery
16378514|NCT00070057|Other|pharmacological study|Correlative studies
16378515|NCT00070057|Other|laboratory biomarker analysis|Correlative studies
16378516|NCT00070031|Drug|edotecarin|
16378517|NCT00070018|Biological|rituximab|250 mg/m^2, as part of Zevalin regimen
16378518|NCT00070018|Drug|Cyclophosphamide|750 mg/m^2
16378519|NCT00070018|Drug|doxorubicin hydrochloride|50 mg/m^2
16378520|NCT00070018|Drug|prednisone|100 mg
16378521|NCT00070018|Drug|vincristine sulfate|1.4 mg/m^2
16378522|NCT00070018|Radiation|radiation therapy|4000-5000 cGy total
16378523|NCT00070018|Biological|Yttrium-90 ibritumomab tiuxetan|0.4 mCi/kg
16378524|NCT00070018|Biological|Indium-111 ibritumomab tiuxetan|5 mCi
16378525|NCT00070005|Procedure|conventional surgery|
16378526|NCT00070005|Procedure|management of therapy complications|
16378527|NCT00069992|Radiation|Total Body Irradiation|Total body irradiation of 450cGy as a single dose, day -6
16378528|NCT00069992|Drug|Fludarabine|Fludarabine 30mg/m2 Day -5 to -2
16378529|NCT00069992|Drug|Campath 1H|Campath 1H dosing as per institutional SOPs Day -5 to -2
16378530|NCT00069966|Biological|filgrastim|
16378531|NCT00069966|Biological|rituximab|
16378532|NCT00069966|Drug|cisplatin|
16378533|NCT00069966|Drug|cytarabine|
16378534|NCT00069966|Drug|methylprednisolone|
16378535|NCT00069966|Drug|pixantrone dimaleate|
16378536|NCT00069966|Procedure|autologous bone marrow transplantation|
16378537|NCT00069966|Procedure|peripheral blood stem cell transplantation|
16378538|NCT00069953|Biological|filgrastim|During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients >70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.
16378539|NCT00069953|Biological|pegfilgrastim|During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.
16378540|NCT00069953|Drug|cisplatin|During induction therapy, patients receive 15 mg/m^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m^2/day by IV over 1 hour beginning on days 57-61.
16378541|NCT00069953|Drug|fluorouracil|During induction therapy, patients receive 650 mg/m^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.
16378542|NCT00069953|Drug|paclitaxel|During induction therapy, patients receive 200 mg/m^2/day by IV over 2 hours on days 1 and 29.
16378543|NCT00069953|Procedure|conventional surgery|Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
16378544|NCT00069953|Radiation|radiation therapy|External beam radiotherapy with megavoltage linear accelerators (> 6 MV) will be used to deliver multiple (> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.
16378545|NCT00069940|Biological|sargramostim|
16378546|NCT00069940|Biological|telomerase: 540-548 peptide vaccine|
16378547|NCT00069927|Drug|Adderall-XR®|Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
16378548|NCT00069927|Drug|Concerta®|Concerta® 18 mg/day for 3-12 weeks depending on subject's response
16378549|NCT00006034|Biological|keyhole limpet hemocyanin|Given intradermally and IV
16378550|NCT00006034|Drug|doxorubicin hydrochloride|Given IV
16378551|NCT00003868|Drug|cyclophosphamide|
16378552|NCT00003868|Drug|methotrexate|
16378553|NCT00003868|Procedure|allogeneic bone marrow transplantation|
16378554|NCT00003868|Procedure|peripheral blood stem cell transplantation|
16378555|NCT00003868|Radiation|iodine I 131 monoclonal antibody BC8|
16378556|NCT00003868|Radiation|radiation therapy|
16378557|NCT00069901|Drug|CT-2103 (poly(L)glutamate-paclitaxel)|
16378558|NCT00069901|Drug|carboplatin|
16378559|NCT00069888|Drug|Docetaxel|
16378560|NCT00069875|Drug|Gemcitabine|
16378561|NCT00069875|Drug|LY293111|
16378562|NCT00069875|Drug|cisplatin|
16378563|NCT00069784|Drug|insulin glargine (HOE901)|Cartridges for use in a pen device, each containing 3 mL of insulin glargine 100 U/mL solution for injection
16378564|NCT00069784|Drug|omega-3 polyunsaturated fatty acids (PUFA)|Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration
16378565|NCT00069784|Drug|placebo|Matching placebo gelatin capsules (containing olive oil) for oral administration
16378566|NCT00069784|Device|reusable pen device for insulin injection|
16378567|NCT00069745|Drug|Satraplatin|
16378568|NCT00069745|Drug|Prednisone|
16378569|NCT00069719|Drug|Glaucoma therapy|
16378570|NCT00069706|Drug|AL-12182 0.003% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16378571|NCT00069706|Other|AL-12182 Ophthalmic Solution Vehicle|Placebo
16378572|NCT00069706|Drug|Latanoprost 0.005% Ophthalmic Solution|Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16380271|NCT00060918|Drug|metoprolol|
16378573|NCT00069706|Drug|AL-12182 0.01% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16378574|NCT00069706|Drug|AL-12182 0.03% Ophthalmic Solution|Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
16378575|NCT00069862|Drug|Deferitrin (GT56-252)|
16378576|NCT00069862|Drug|desferoxamine (DFO)|
16378577|NCT00069836|Drug|Rosiglitazone/metformin|
16378578|NCT00069823|Drug|Esomeprazole|Proton pump inhibitor 40 mg orally twice daily
16378579|NCT00069823|Drug|Placebo proton pump inhibitor|Placebo proton pump inhibitor
16378580|NCT00069732|Behavioral|qigong|
16378581|NCT00069732|Behavioral|acupressure-TAT|
16378582|NCT00069849|Drug|ABT-089|
16378583|NCT00069758|Drug|SDX-105|
16378584|NCT00069641|Biological|Iduronate-2-sulfatase enzyme replacement therapy|Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.
16378585|NCT00069641|Biological|iduronate-2-sulfatase enzyme replacement therapy|Patients will receive every other week infusions of idursulfase at a dose of 0.5 mg/kg.
16378586|NCT00069641|Biological|Placebo|Patients will receive weekly infusions of placebo.
16378587|NCT00069524|Drug|oyster mushroom|
16378588|NCT00005630|Biological|ras peptide cancer vaccine|
16378589|NCT00005630|Biological|sargramostim|
16378590|NCT00005629|Biological|AFP gene hepatocellular carcinoma vaccine|"Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides emulsified in 2 ml of Montanide ISA-51.
~Group A AFP peptide dose 100 ug Group B AFP peptide dose 500 ug Group C AFP peptide dose 1000 ug"
16378591|NCT00004922|Drug|irinotecan hydrochloride|
16378592|NCT00004886|Drug|docetaxel|
16378593|NCT00004886|Drug|dofequidar fumarate|
16378594|NCT00069654|Procedure|Forearm blood flow study|
16378595|NCT00069654|Procedure|Brachial artery reactivity study|
16378596|NCT00069654|Procedure|Treadmill exercise test|
16378597|NCT00069628|Device|GlucoWatch® G2™ Biographer (GW2B)|
16378598|NCT00069628|Device|Continuous Glucose Monitoring System (CGMS)|
16378599|NCT00069615|Device|GlucoWatch® G2™ Biographer (GW2B)|
16378600|NCT00069615|Device|Continuous Glucose Monitoring System™ (CGMS)|
16378601|NCT00069602|Device|Continuous Glucose Monitoring System (CGMS)|
16378602|NCT00069602|Device|GlucoWatch G2TM Biographer (GW2B)|
16378603|NCT00069576|Behavioral|nutritional counseling|
16378604|NCT00069576|Behavioral|self blood glucose monitoring|
16378605|NCT00069563|Behavioral|Reaching Educators, Children, and Parents (RECAP)|
16378606|NCT00069550|Drug|dextromethorphan|
16378607|NCT00069550|Drug|donepezil hydrochloride|
16378608|NCT00069537|Device|The GlucoWatch® G2™ Biographer (GW2B)|
16378609|NCT00069537|Device|The Continuous Glucose Monitoring System (CGMS™)|
16378610|NCT00069511|Drug|UT-231B|
16378611|NCT00069498|Drug|5-aminosalicylic acid|
16378612|NCT00004883|Biological|trastuzumab|Given IV
16378613|NCT00004883|Other|laboratory biomarker analysis|Correlative studies
16378614|NCT00004856|Biological|trastuzumab|Given IV
16378615|NCT00003930|Drug|cisplatin|
16378616|NCT00003930|Drug|gemcitabine hydrochloride|
16378617|NCT00003930|Drug|paclitaxel|
16378618|NCT00003930|Procedure|conventional surgery|
16378619|NCT00003930|Radiation|radiation therapy|
16378620|NCT00003832|Drug|bromodeoxyuridine|Given IV
16378621|NCT00003832|Procedure|conventional surgery|Undergo surgery
16378622|NCT00003832|Other|laboratory biomarker analysis|Correlative studies
16378623|NCT00069459|Drug|Extended-release Bupropion Hydrochloride|Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride
16378624|NCT00069446|Drug|rhuMAb VEGF (telbermin)|
16378625|NCT00069420|Behavioral|Cognitive Motivational Behavior Therapy|
16378626|NCT00069407|Procedure|Electroconvulsive Therapy|Electroconvulsive therapy
16378627|NCT00069381|Behavioral|Psychotherapy treatment|
16378628|NCT00003827|Drug|amifostine trihydrate|
16378629|NCT00003827|Drug|cytarabine|
16378630|NCT00003827|Drug|topotecan hydrochloride|
16378631|NCT00003620|Drug|alvocidib|Given IV
16378632|NCT00003620|Other|laboratory biomarker analysis|Correlative studies
16378633|NCT00003594|Drug|irinotecan|
16378634|NCT00003594|Drug|fluorouracil|
16378635|NCT00003594|Drug|leucovorin calcium|
16378636|NCT00003594|Drug|oxaliplatin|
16378637|NCT00003540|Drug|gemcitabine hydrochloride|
16378638|NCT00003463|Drug|carmustine|
16378639|NCT00003463|Drug|irinotecan hydrochloride|
16378640|NCT00003463|Drug|polifeprosan 20 with carmustine implant|
16378641|NCT00003463|Procedure|surgical procedure|
16378642|NCT00069355|Drug|Propranolol|
16378643|NCT00069277|Drug|E7389|
16378644|NCT00069264|Drug|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
16378645|NCT00069251|Drug|Bupropion|
16378646|NCT00003449|Drug|dexamethasone|
16378647|NCT00003449|Drug|gemcitabine hydrochloride|
16378648|NCT00003449|Drug|paclitaxel|
16378649|NCT00003281|Drug|paclitaxel|
16378650|NCT00003281|Drug|topotecan hydrochloride|
16378651|NCT00003281|Radiation|radiation therapy|
16378652|NCT00003280|Biological|rituximab|
16378653|NCT00003245|Drug|irinotecan hydrochloride|
16378654|NCT00003113|Biological|filgrastim|Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle.
16378655|NCT00003113|Drug|cyclophosphamide|Cyclophosphamide are given on days 22-31 of each cycle.
16378656|NCT00003113|Drug|etoposide|Etoposide is given on days 1-3.
16378657|NCT00003113|Drug|lomustine|Lomustine is given on day 1 of cycles 1 and 3 only.
16380361|NCT00004059|Drug|fluorouracil|
16378658|NCT00003113|Drug|procarbazine hydrochloride|Procarbazine are given on days 22-31 of each cycle.
16378659|NCT00003113|Radiation|radiation therapy|Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy.
16378660|NCT00069329|Drug|anakinra|daily injection of subcutaneous injection
16378661|NCT00069316|Drug|Omr-IgG-am|
16378662|NCT00069186|Drug|Creatine Monohydrate|
16378663|NCT00069238|Biological|Alemtuzumab (Campath)|Alemtuzumab (Campath) followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) every 3 weeks for up to 6 cycles.
16378664|NCT00069238|Drug|EPOCH|Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) + Alemtuzumab (Campath) every 3 weeks for up to 6 cycles.
16378665|NCT00069121|Drug|Capecitabine|1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.
16378666|NCT00069121|Drug|Oxaliplatin|130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
16378667|NCT00069121|Drug|Leucovorin (LV)|Administered by one of two regimens, as specified in the arm description.
16378668|NCT00069121|Drug|5-Fluorouracil (5-FU)|Administered by one of two regimens, as specified in the arm description.
16378669|NCT00069108|Drug|5 FU|As prescribed, in 2 week cycles
16378670|NCT00069108|Drug|Leucovorin|As prescribed, in 2 week cycles
16378671|NCT00069108|Drug|Oxaliplatin|As prescribed, in 3 week cycles
16378672|NCT00069108|Drug|Oxaliplatin|As prescribed, in 2 week cycles
16378673|NCT00069108|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-15 of each 3 week cycle
16378674|NCT00069095|Drug|Oxaliplatin 130 mg/m^2|Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
16378675|NCT00069095|Drug|Capecitabine 1000 mg/m^2|Capecitabine was taken within 30 min after the end of breakfast and dinner.
16378676|NCT00069095|Drug|Bevacizumab 7.5 mg/kg|Bevacizumab was administered in a 30 to 90 min infusion.
16378677|NCT00069095|Drug|Placebo for bevacizumab 7.5 mg/kg|Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
16378678|NCT00069095|Drug|Oxaliplatin 85 mg/m^2|Oxaliplatin 85 mg/m^2 was administered simultaneously with leucovorin in a 2 h infusion.
16378679|NCT00069095|Drug|Leucovorin 200 mg/m^2|Leucovorin was administered simultaneously with oxaliplatin 85 mg/m^2 in a 2 h infusion.
16378680|NCT00069095|Drug|Fluorouracil 400 mg/m^2|
16378681|NCT00069095|Drug|Bevacizumab 5 mg/kg|Bevacizumab was administered in a 30 to 90 min infusion.
16378682|NCT00069095|Drug|Placebo for bevacizumab 5 mg/kg|Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
16378683|NCT00002638|Biological|filgrastim|
16378684|NCT00002638|Biological|sargramostim|
16378685|NCT00002638|Drug|carmustine|
16378686|NCT00002638|Drug|cyclophosphamide|
16378687|NCT00002638|Drug|cytarabine|
16378688|NCT00002638|Drug|etoposide|
16378689|NCT00002638|Procedure|peripheral blood stem cell transplantation|
16378690|NCT00002638|Radiation|radiation therapy|
16378691|NCT00002559|Biological|filgrastim|
16378692|NCT00002559|Drug|cisplatin|
16378693|NCT00002559|Drug|ifosfamide|
16378694|NCT00002559|Drug|paclitaxel|
16378695|NCT00002533|Drug|fluconazole|
16378696|NCT00002533|Radiation|radiation therapy|
16378697|NCT00069173|Behavioral|Project FAB (Fitness and Bone)|
16378698|NCT00069134|Dietary Supplement|sulfur amino acids|Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine
16378699|NCT00069017|Biological|MEDI-522|MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL.
16378700|NCT00069017|Other|Placebo|Placebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D&C Yellow #10.
16378701|NCT00030381|Drug|4'-iodo-4'-deoxydoxorubicin|Given IV
16378702|NCT00030381|Other|pharmacological study|Correlative studies
16378703|NCT00026286|Drug|conjugated estrogens|
16378704|NCT00026286|Drug|medroxyprogesterone|
16378705|NCT00025116|Drug|gefitinib|
16378706|NCT00069160|Drug|docetaxel|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8.
16378707|NCT00069160|Drug|tariquidar|Patients receive tariquidar intravenous (IV) over 30 minutes on days 8 and 22.
16378708|NCT00069160|Other|99mTc-sestamibi imaging|Bolus injection of 29 mCi of 99mTc-sestamibi intravenously for each imaging study.
16378709|NCT00069082|Drug|Civamide (Zucapsaicin)|Nasal Solution 0.01%
16378710|NCT00069082|Drug|Sodium Chloride|Nasal Solution 10%
16378711|NCT00069030|Biological|VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade-Env) with adjuvant VRC-ADJDNA004-IL2-VP|
16378712|NCT00068991|Behavioral|HIV skills training program and questionnaire|Two-hour weekly skills training sessions followed by evaluation questionnaire
16378713|NCT00068991|Behavioral|Community-level stigma reduction program|Two-hour training sessions focusing on anti-stigma and anti-discrimination
16378714|NCT00068991|Behavioral|Cross-sectional survey|Survey evaluation of community attitudes towards HIV
16378715|NCT00068952|Drug|Edotecarin|
16378716|NCT00068952|Drug|Temozolomide|
16378717|NCT00068952|Drug|Carmustine (BCNU)|
16378718|NCT00068952|Drug|Lomustine (CCNU)|
16378719|NCT00069069|Drug|Intransal instillation of E-selectin|Intranasal recombinant human E-selectin
16378720|NCT00069056|Procedure|Laser Treatment|
16378721|NCT00068913|Drug|Dichloroacetate|
16378722|NCT00068874|Behavioral|Coping skills and cognitive restructuring techniques|This is a cognitive psychoeducational program designed to enhance coping and adaptation to SLE. Participants will attend five study visits over 5 months. The first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. The coping skills training will include training in relaxation, distraction, and problem-solving skills. The cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses.
16378794|NCT00068406|Procedure|Conventional Surgery|
16378723|NCT00068874|Behavioral|Educational training|Participants will attend five study visits that will include disease-appropriate education materials.
16378724|NCT00068861|Drug|metformin XR|
16378725|NCT00068861|Drug|clomiphene citrate|
16378726|NCT00068848|Behavioral|Quick start oral contraceptive initiation|
16378727|NCT00068835|Behavioral|Lindamood-Bell training for dyslexia|
16378728|NCT00068822|Device|Percutaneous vertebroplasty|Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture
16378729|NCT00068822|Procedure|Sham vertebroplasty|Participants, following local anesthesia with lidocaine and bupivacaine, were given verbal and physical cues such as pressure on the back, but the needle was not placed.
16378730|NCT00068809|Procedure|Short Cycle Antiretroviral Therapy|
16378731|NCT00068783|Drug|imatinib mesylate|Given orally
16378732|NCT00068783|Other|laboratory biomarker analysis|Correlative studies
16378733|NCT00068770|Radiation|radiation therapy|Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment
16378734|NCT00068770|Drug|Celecoxib|Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.
16378735|NCT00068757|Biological|trastuzumab|
16378736|NCT00068757|Drug|lonafarnib|
16378737|NCT00068757|Drug|paclitaxel|
16378738|NCT00068757|Other|pharmacological study|
16378739|NCT00068744|Drug|cisplatin|
16378740|NCT00068744|Drug|fluorouracil|
16378741|NCT00068744|Drug|mitomycin C|
16378742|NCT00068744|Radiation|radiation therapy|
16378743|NCT00068731|Dietary Supplement|lycopene|
16378744|NCT00068718|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
16378745|NCT00068692|Radiation|Radiotherapy|Undergo external beam radiation therapy
16378746|NCT00068692|Drug|Fluorouracil|Given IV
16378747|NCT00068692|Drug|Leucovorin Calcium|Given IV
16378748|NCT00068692|Drug|Oxaliplatin|Given IV
16378749|NCT00068692|Drug|Irinotecan|Given IV
16378750|NCT00068666|Drug|temozolomide|
16378751|NCT00068666|Radiation|radiation therapy|
16378752|NCT00068653|Drug|Celecoxib|Celecoxib 400mg orally two times a day, taken with meals.
16378753|NCT00068653|Drug|ZD1839|ZD1839 250 mg po every day, taken with or without food.
16378754|NCT00068614|Biological|HER-2/neu peptide vaccine|
16378755|NCT00068601|Drug|cyclophosphamide|Part of planned chemotherapy regimen
16378756|NCT00068601|Drug|goserelin acetate|Given subcutaneously
16378757|NCT00068588|Biological|GTI-2040|Given IV
16378758|NCT00068588|Drug|capecitabine|Given orally
16378759|NCT00068575|Biological|Recombinant Interferon Alfa|3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.
16378760|NCT00068575|Drug|Cisplatin|30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.
16378761|NCT00068575|Drug|Fluorouracil|175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.
16378762|NCT00068575|Radiation|Radiation Therapy|External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.
16378763|NCT00068549|Drug|Gemcitabine Hydrochloride|Given IV
16378764|NCT00068549|Drug|Cisplatin|Given IV
16378765|NCT00068549|Radiation|Radiation Therapy|Undergo whole pelvis radiotherapy
16378766|NCT00068549|Radiation|Internal Radiation Therapy|Undergo brachytherapy
16378767|NCT00068523|Biological|anti-thymocyte globulin|anti-thymocyte globulin IV over 4 hours on days -2 to -1
16378768|NCT00068523|Drug|cyclophosphamide|cyclophosphamide IV over 1 hour on days -3 to -2
16378769|NCT00068523|Drug|cyclosporine|oral cyclosporine on days -1 to 100
16378770|NCT00068523|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
16378771|NCT00068523|Drug|methylprednisolone|methylprednisolone (oral or IV) on days 5-15
16378772|NCT00068523|Procedure|UV light therapy|Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
16378773|NCT00068523|Procedure|allogeneic bone marrow transplantation|
16378774|NCT00068523|Procedure|peripheral blood stem cell transplantation|Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
16378775|NCT00068510|Biological|therapeutic autologous dendritic cells|
16378776|NCT00068497|Drug|gefitinib|Given orally
16378777|NCT00068484|Drug|topotecan hydrochloride|Given IV
16378778|NCT00068484|Drug|bortezomib|Given IV
16378779|NCT00068484|Other|pharmacological study|Correlative studies
16378780|NCT00068484|Other|laboratory biomarker analysis|Correlative studies
16378781|NCT00068471|Drug|anidulafungin|
16378782|NCT00068458|Dietary Supplement|Calcium-Rich Diet|1,200 - 2,500 mg/day. 6 month intervention
16378783|NCT00068458|Other|Arm 2: Exercise + Calcium-Rich Diet|Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.
16378784|NCT00068458|Other|Exercise + Fruit & Vegetable, Low Fat + Calcium Diet|1,200 - 2,500 Calcium intake per day. 6 month intervention period.
16378785|NCT00068445|Drug|lamotrigine|
16378786|NCT00068445|Other|Placebo|
16378787|NCT00068432|Drug|Celecoxib|Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
16378788|NCT00068432|Drug|Gemcitabine Hydrochloride|Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
16378789|NCT00068419|Drug|tamoxifen citrate|Given orally
16378790|NCT00068419|Drug|sulindac|Given orally
16378791|NCT00068419|Other|laboratory biomarker analysis|Correlative studies
16378792|NCT00068406|Radiation|3-Dimensional Conformal Radiation Therapy|
16378793|NCT00068406|Drug|Cisplatin|Given IV
16378795|NCT00068393|Drug|Doxorubicin|Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.
16378796|NCT00068393|Drug|Gemcitabine|Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.
16378797|NCT00068393|Drug|G-CSF (granulocyte-colony stimulating factor)|Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.
16378798|NCT00068393|Drug|Neulasta|Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.
16378799|NCT00068380|Drug|imatinib mesylate|Given orally
16378800|NCT00068380|Other|laboratory biomarker analysis|Correlative studies
16378801|NCT00068367|Drug|erlotinib hydrochloride|150 mg per day, daily until disease progression
16378802|NCT00068341|Biological|trastuzumab|Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
16378803|NCT00068341|Drug|carboplatin|Cycle 1-8 Day 1 or 2 AUC = 6 IV
16378804|NCT00068341|Drug|docetaxel|Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
16378805|NCT00068341|Biological|trastuzumab|"Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
16378806|NCT00068328|Procedure|psychosocial assessment and care|
16378807|NCT00068328|Procedure|quality-of-life assessment|
16378808|NCT00068315|Drug|bortezomib|Given IV
16378809|NCT00068315|Drug|fludarabine phosphate|Given IV
16378810|NCT00068315|Biological|rituximab|Given IV
16378811|NCT00068302|Drug|sirolimus|3-6 subjects will be enrolled into each dose level
16378812|NCT00068289|Drug|bortezomib|
16378813|NCT00068276|Dietary Supplement|cholecalciferol|
16378814|NCT00068263|Radiation|radiation therapy|
16378815|NCT00068250|Drug|rituximab|375 mg/m2, intravenously three days prior to the first cycle of methotrexate
16378816|NCT00068250|Drug|methotrexate|Five cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar.
16378817|NCT00068250|Drug|temozolomide 100 mg/m^2|Temozolomide 100 mg/m^2 by mouth per day for five days on weeks 4 and 8.
16378818|NCT00068250|Drug|temozolomide 150 mg/m^2|Temozolomide 150 mg/m^2 by mouth per day for five days on weeks 4 and 8.
16378819|NCT00068250|Drug|temozolomide 200 mg/m^2|Temozolomide 200 mg/m^2 per day by mouth for five days on weeks 4 and 8.
16378820|NCT00068250|Radiation|radiation therapy|Whole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy.
16378821|NCT00068250|Drug|post-radiation therapy temozolomide|Temozolomide (TMZ) 200 mg/m^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles.
16378822|NCT00068237|Procedure|salivary gland transfer|Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
16378823|NCT00068237|Radiation|Post-operative radiation therapy|Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.
16378824|NCT00068211|Drug|ILX651|
16378825|NCT00068198|Biological|Dryvax|
16378826|NCT00068185|Drug|Black cohosh|
16378827|NCT00068172|Drug|PI-88|
16378828|NCT00068133|Genetic|Plasmid based Gene Transfer product-VLTS-589|
16378829|NCT00025207|Drug|gefitinib|Given orally
16378830|NCT00025207|Other|laboratory biomarker analysis|Correlative studies
16378831|NCT00021268|Drug|tocladesine|
16378832|NCT00020904|Drug|ixabepilone|
16378833|NCT00068094|Drug|Probiotic-containing powder|
16378834|NCT00068081|Drug|Capsaicin Dermal Patch|
16378835|NCT00017043|Drug|ixabepilone|
16378836|NCT00016939|Drug|alvocidib|
16378837|NCT00016874|Drug|cisplatin|
16378838|NCT00016874|Drug|paclitaxel|
16378839|NCT00016874|Drug|triapine|
16378840|NCT00016341|Biological|filgrastim|
16378841|NCT00016341|Drug|cisplatin|
16378842|NCT00016341|Drug|doxorubicin hydrochloride|
16378843|NCT00016341|Drug|megestrol acetate|
16378844|NCT00016341|Drug|paclitaxel|
16378845|NCT00016341|Drug|tamoxifen citrate|
16378846|NCT00068107|Drug|Replagal|enzyme replacement therapy
16378847|NCT00068068|Drug|Talaporfin sodium (LS11)|
16378848|NCT00068068|Device|LED-based light infusion device|
16378849|NCT00068068|Device|Light emitting diodes (LED)|
16378850|NCT00068068|Procedure|Photodynamic therapy|
16378851|NCT00068068|Procedure|Phototherapy|
16378852|NCT00068068|Procedure|Chemotherapy|
16378853|NCT00068055|Drug|Omr-lgG-am|Omr-IgG-am™ 5% is provided in 100 ml bottles (5.0 grams) as a sterile solution containing 5% protein, 10% maltose and water for injection. This product is licensed in Israel, but not in the US.
16378854|NCT00068055|Drug|Polygam® S/D|Polygam® S/D is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. When reconstituted (5%) with the supplied diluent (sterile water for injection, USP) Polygam® S/D contains approximately 50mg of protein per ml (approximately 90% is gamma globulin); 3mg/ml human albumin, 22.5 mg/ml glycine, 20 mg/ml glucose, 2mlg/ml polyethylene glycol (PEG), 1 mcg/ml tri-nbutyl phosphate, 1 mcg/ml octoxynol 9, and 100 mcg/ml polysorbate 80.
16378855|NCT00068055|Drug|Placebo|Normal Saline.
16378856|NCT00068042|Drug|Pegvisomant|
16378857|NCT00068042|Drug|Sandostatin LAR|
16378858|NCT00067899|Drug|Vitamin E with and without Vitamin C|
16378859|NCT00068029|Drug|Pegvisomant/ Sandostatin LAR|
16378860|NCT00068029|Drug|Sandostatin LAR|
16378861|NCT00068029|Drug|Pegvisomant|
16378862|NCT00067990|Drug|Losartan 100mg|To be started within three months of transplant and continued for five years.
16378863|NCT00067990|Drug|Placebo|No treatment with continued follow-up for five years.
16378864|NCT00067964|Behavioral|small changes in physical activity and diet|
16378865|NCT00067951|Drug|rosiglitazone/metformin|
16378866|NCT00067938|Drug|lamotrigine|Lamotrigine
16378867|NCT00067925|Behavioral|Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program|
16378868|NCT00016276|Drug|dexrazoxane hydrochloride|Given IV
16378869|NCT00016276|Drug|doxorubicin hydrochloride|Given IV
16378870|NCT00016276|Drug|cyclophosphamide|Given IV
16378871|NCT00016276|Drug|paclitaxel|Given IV
16378872|NCT00016276|Biological|trastuzumab|Given IV
16378873|NCT00016276|Procedure|therapeutic conventional surgery|Undergo breast conservation surgery, modified radical mastectomy, or mastectomy
16378874|NCT00016276|Radiation|radiation therapy|Undergo radiation therapy
16378875|NCT00016276|Drug|tamoxifen citrate|Given orally
16378876|NCT00016276|Other|laboratory biomarker analysis|Correlative studies
16378877|NCT00010036|Drug|carboplatin|
16378878|NCT00010036|Drug|irinotecan hydrochloride|
16378879|NCT00010036|Radiation|radiation therapy|
16378880|NCT00008359|Drug|caspofungin acetate|
16378881|NCT00008359|Drug|liposomal amphotericin B|
16378882|NCT00008086|Dietary Supplement|calcitriol|
16378883|NCT00008086|Drug|carboplatin|
16378884|NCT00006346|Procedure|psychosocial assessment and care|
16378885|NCT00006346|Procedure|quality-of-life assessment|
16378886|NCT00067912|Drug|Duloxetine Hydrochloride|
16378887|NCT00067912|Drug|Venlafaxine Extended Release|
16378888|NCT00006265|Drug|ara-C|3 g/sq m IV infusion over 3 hours Days 1-5
16378889|NCT00006265|Biological|gemtuzumab ozogamicin|9 mg/sq m IV infusion over 2 hrs D 1 (Cohort I); D 7 (Cohorts II, IA, & IV); & D 14 (Cohort IV) 4.5 mg/sq m IV infusion over 2 hrs D 8 (Cohort I) & D 14 (Cohort II)
16378890|NCT00006254|Biological|salmonella VNP20009|
16378891|NCT00006223|Biological|recombinant flt3 ligand|
16378892|NCT00006103|Drug|fluorouracil|
16378893|NCT00006103|Drug|irinotecan hydrochloride|
16378894|NCT00006103|Drug|leucovorin calcium|
16378895|NCT00006096|Drug|cisplatin|
16378896|NCT00006096|Radiation|radiation therapy|
16378897|NCT00067873|Behavioral|Diet|
16378898|NCT00067873|Behavioral|Aerobic exercise|
16378899|NCT00067873|Behavioral|Resistance exercise|
16378900|NCT00067860|Drug|recombinant human growth hormone|
16378901|NCT00067860|Behavioral|diet modification|
16378902|NCT00067847|Behavioral|State-directed nutrition policy change|
16378903|NCT00067834|Device|Pulsing electromagnetic field (PEMF)|
16378904|NCT00006019|Drug|azacitidine|
16378905|NCT00006019|Drug|sodium phenylbutyrate|
16378906|NCT00006002|Drug|dexamethasone|
16378907|NCT00006002|Drug|semaxanib|
16378908|NCT00005887|Drug|efaproxiral|
16378909|NCT00005887|Radiation|radiation therapy|
16378910|NCT00005886|Drug|arzoxifene hydrochloride|
16378911|NCT00005886|Drug|tamoxifen citrate|
16378912|NCT00005857|Biological|trastuzumab|
16378913|NCT00005857|Drug|docetaxel|
16378914|NCT00005845|Drug|tipifarnib|Given PO
16378915|NCT00005845|Other|laboratory biomarker analysis|Correlative studies
16378916|NCT00005845|Other|pharmacological study|Correlative studies
16378917|NCT00067808|Drug|Decitabine|10 mg/m^2 by vein over 1 hour daily for 10 days
16378918|NCT00067808|Drug|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days
16378919|NCT00067808|Drug|Decitabine|20 mg/m2 subcutaneous (SQ) daily x 5 days
16378920|NCT00067782|Drug|Atazanavir (immediate switch)|Capsules, Oral, 400mg, Once daily, 48 weeks.
16378921|NCT00067782|Drug|Atazanavir (Week 24 switch)|Capsules, Oral, 400mg, Once daily, 48 weeks.
16378922|NCT00067769|Behavioral|Internet-based intervention UCanPoopToo|Internet-based intervention to administer Enhanced Toilet Training (ETT).
16378923|NCT00067769|Behavioral|treatment as usual|Routine clinical care.
16378924|NCT00005804|Drug|cyclophosphamide|
16378925|NCT00005804|Procedure|allogeneic bone marrow transplantation|
16378926|NCT00005804|Radiation|radiation therapy|
16378927|NCT00005090|Biological|bleomycin sulfate|10 U/m^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
16378928|NCT00005090|Drug|carmustine|150/m^2 on days -6 to -4 (4-6 days before transplant).
16378929|NCT00005090|Drug|cyclophosphamide|100 mg/kg on day -2 (2 days before transplant).
16378930|NCT00005090|Drug|dacarbazine|375 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
16378931|NCT00005090|Drug|doxorubicin hydrochloride|25 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
16378932|NCT00005090|Drug|etoposide|60 mg/kg on day -4 (4 days before transplant).
16378933|NCT00005090|Drug|vinblastine|6 mg/m^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
16378934|NCT00005090|Procedure|peripheral blood stem cell transplantation|2 x 10^6 CD34+ blood mononuclear cells/kg of actual body weight
16378935|NCT00067756|Drug|4-PBA|During the first 3 days of this phase baseline serum AAT levels will be determined. The participants will be then given increased amounts of 4-PBA orally in 6 divided doses (day 4-6, 30 g/day and day 7-9, 40/day
16380362|NCT00004052|Biological|QS21|
16378936|NCT00067743|Drug|Lenalidomide|supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
16378937|NCT00067730|Drug|Drotrecogin Alfa (activated)|
16378938|NCT00067717|Behavioral|Distance healing|
16378939|NCT00067704|Behavioral|Trauma writing|
16378940|NCT00067704|Behavioral|Writing about daily events|
16378941|NCT00067691|Procedure|Acupuncture|
16378942|NCT00067678|Drug|soy protein|
16378943|NCT00067665|Other|Ultrafiltration|All patients participating in the trial require evaluation of dry-weight at each dialysis visit for evaluation. An initial weight loss of 0.1kg/10 kg body-weight will be prescribed per dialysis. If ultrafiltration is not tolerated based on muscle cramps, need for excessive saline or symptomatic hypotension, the intensity of ultrafiltration will be reduced by 50%. If ultrafiltration is still not tolerated, the weight loss will be further reduced by 50%. If the patient cannot tolerate at least 0.2 kg incremental weight loss per dialysis, the patient will be said to be at goal dry-weight. Thus, by this protocol, all patients must experience symptoms of volume depletion to be at dry weight.
16378944|NCT00067652|Behavioral|Education and awareness about body image issues.|
16378945|NCT00067639|Drug|Pegfilgrastim (Neulasta)|12 mg single injection of pegfilgrastim under the skin prior to apheresis.
16378946|NCT00067639|Procedure|Apheresis|Collection of stem cells, repeated daily until target stem cell dose reached, maximum of 5 procedures.
16378947|NCT00067626|Dietary Supplement|Chromium|500/1000 mcg oral chromium picolinate taken daily or placebo (crossover)
16378948|NCT00067613|Other|Benchmarking Management Practices|"The Benchmarking intervention included:
~Data feedback: Using existing data from the NRN Generic Database and Key Care Practices Survey at their NICU to collect data on the perceptions of care.
~Training in Continuous Quality Improvement (CQI) Techniques
~Review of best existing evidence
~Site visits to the Centers with the Lowest Rates of BPD
~Selection of Practices to change: Each site team selected practices for modification at their own center"
16378949|NCT00067613|Other|Standard Management Practices|Centers assigned to the control group continued to receive routine information on their own center's outcomes, and all information routinely supplied within the NRN. Control centers did not participate in organized discussions of the interventions applied within the Benchmarking centers. At the completion of the study, Control Centers were offered a workshop on the Benchmarking techniques.
16378950|NCT00067600|Behavioral|Diet with increased fruits, vegetables, and calcium|
16378951|NCT00067600|Behavioral|Increased high impact activity and resistance training|
16378952|NCT00067574|Behavioral|Structured treatment interruption|
16378953|NCT00067561|Drug|Alosetron|
16378954|NCT00067548|Drug|EKB-569|
16378955|NCT00067535|Drug|Cocaine-Related Disorders|
16378956|NCT00067522|Behavioral|User-independent contraception program|
16378957|NCT00067522|Behavioral|Future Planning Perspectives program|
16378958|NCT00067509|Drug|emergency contraception (estrogen/progesterone)|
16378959|NCT00067470|Drug|Placebo|
16378960|NCT00067470|Drug|N-acetylgalactosamine 4-sulfatase|
16378961|NCT00004256|Biological|sargramostim|
16378962|NCT00004256|Procedure|quality-of-life assessment|
16378963|NCT00004256|Radiation|radiation therapy|
16378964|NCT00004233|Drug|fluorouracil|
16378965|NCT00004233|Drug|leucovorin calcium|
16378966|NCT00004233|Drug|triacetyluridine|
16378967|NCT00004221|Drug|Carboplatin|Given IV
16378968|NCT00004221|Drug|Cyclophosphamide|Given IV
16378969|NCT00004221|Biological|Filgrastim|Given SQ
16378970|NCT00004221|Drug|Paclitaxel|Given IV
16378971|NCT00004221|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplantation
16378972|NCT00004221|Drug|Topotecan Hydrochloride|Given IV
16378973|NCT00004125|Drug|cyclophosphamide|
16378974|NCT00004125|Drug|docetaxel|
16378975|NCT00004125|Drug|doxorubicin hydrochloride|
16378976|NCT00004125|Drug|paclitaxel|
16378977|NCT00004125|Drug|tamoxifen citrate|
16378978|NCT00004125|Radiation|radiation therapy|
16378979|NCT00004032|Biological|ALVAC-hB7.1|Given IP
16378980|NCT00004032|Biological|recombinant interferon gamma|Given IP
16378981|NCT00004032|Other|laboratory biomarker analysis|Correlative studies
16378982|NCT00067496|Drug|Modafinil|
16378983|NCT00067457|Drug|alosetron|
16378984|NCT00067444|Drug|Paroxetine CR|
16378985|NCT00067431|Drug|Divalproex Sodium (Depakote® Sprinkle Capsules)|
16378986|NCT00067405|Drug|Intravenous micronutrient therapy|
16378987|NCT00067392|Procedure|Dental Implant|Dental Implant 4 month time frame
16378988|NCT00067340|Drug|Chlorhexidine mouth rinse|women received daily chlorhexidine oral rinses for two weeks prior to delivery of the infant.
16378989|NCT00067340|Other|Xylitol chewing gum|Women were asked to chew xylitol chewing gum three times per day following the birth of their infant for up to two years postpartum
16378990|NCT00004004|Drug|procarbazine hydrochloride|
16378991|NCT00003931|Genetic|reverse transcriptase-polymerase chain reaction|
16378992|NCT00003890|Drug|MG 98|
16378993|NCT00003736|Drug|motexafin gadolinium|
16378994|NCT00003736|Procedure|biopsy|
16378995|NCT00003736|Procedure|breast imaging study|
16378996|NCT00003736|Procedure|comparison of screening methods|
16378997|NCT00003736|Procedure|magnetic resonance imaging|
16378998|NCT00003736|Procedure|study of high risk factors|
16378999|NCT00003464|Drug|temozolomide|
16379000|NCT00003464|Radiation|radiation therapy|
16379001|NCT00067379|Procedure|interceptive orthodontic treatments|orthodontic procedures
16379002|NCT00067366|Behavioral|Cognitive-Behavioral treatment|Cognitive-Behavioral skills training for chronic pain
16379003|NCT00067366|Behavioral|Attention and lifestyle counseling|Attention and lifestyle counseling added to Standard Care
16379004|NCT00067353|Drug|Fluoride varnish|
16379005|NCT00067327|Drug|Inosine|
16379006|NCT00067314|Drug|Edotecarin|
16379007|NCT00067301|Drug|Polyunsaturated Fatty Acids (PUFA)|
16379008|NCT00067301|Drug|Citalopram|
16379009|NCT00067288|Behavioral|Meaning-Centered Group Psychotherapy|
16379010|NCT00067288|Behavioral|Standard Supportive Group Psychotherapy|
16379011|NCT00067262|Drug|Divalproex Sodium Extended-Release Tablets|
16379012|NCT00067236|Drug|PG-116800 (given as PG-530742)|200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
16379013|NCT00067236|Drug|Placebo tablet|placebo tablet, twice a day for 90 days
16379014|NCT00067210|Device|Head and Neck Cooling System|
16379015|NCT00067184|Device|Toitu 320/325|Fetal monitor
16379016|NCT00067171|Behavioral|Behavior Therapy|
16379017|NCT00067158|Drug|nicotine transdermal system|
16379018|NCT00067145|Behavioral|Face-to-face maintenance program|
16379019|NCT00067145|Behavioral|Internet maintenance program|
16379020|NCT00067132|Procedure|Juven (nutritional), HMB (nutritional)|
16379021|NCT00067119|Drug|Aggrenox|
16379022|NCT00067119|Drug|Placebo|
16379023|NCT00067093|Drug|SanOrg34006|
16379024|NCT00067093|Drug|LMW heparin|
16379025|NCT00067093|Drug|Unfractionated heparin|
16379026|NCT00067093|Drug|Vitamin K antagonist (VKA)|
16379027|NCT00067080|Drug|ICL670, deferoxamine|
16379028|NCT00067041|Drug|Remodulin (treprostinil sodium) Injection|
16379029|NCT00067028|Drug|Clofarabine 40mg/m^2|40 mg/m^2 by vein over 1 hour daily for 5 days.
16379030|NCT00067028|Drug|Idarubicin 10mg/m^2|"10 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.
~Clofarabine + Idarubicin plus Ara-C:
~6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."
16379031|NCT00067028|Drug|Ara-C 0.75 g/m^2|0.75 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.
16379032|NCT00067028|Drug|Clofarabine 22.5mg/m^2|22.5 mg/m^2 by vein over 1 hour daily for 5 days.
16379033|NCT00067028|Drug|Ara-C 1 g/m^2|1 g/m^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.
16379034|NCT00067028|Drug|Idarubicin 6 mg/m^2|6 mg/m^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.
16379035|NCT00003433|Biological|carcinoembryonic antigen RNA-pulsed DC cancer vaccine|
16379036|NCT00003323|Drug|finasteride|5 mg/d PO
16379037|NCT00003323|Drug|flutamide|250 mg PO tid
16379038|NCT00003323|Other|quality-of-life assessment|Assessment survey administered at baseline, and 3 & 6 months post initiation of treatment
16379039|NCT00003210|Biological|recombinant interleukin-12|Given subcutaneously
16379040|NCT00003210|Other|laboratory biomarker analysis|Correlative studies
16379041|NCT00003114|Biological|filgrastim|Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
16379042|NCT00003114|Drug|cyclophosphamide|Oral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
16379043|NCT00003114|Drug|etoposide|Oral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
16379044|NCT00003114|Drug|lomustine|Patients receive oral lomustine on day 1.
16379045|NCT00003114|Drug|procarbazine hydrochloride|Oral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
16379046|NCT00003114|Radiation|radiation therapy|Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.
16379047|NCT00003006|Genetic|reverse transcriptase-polymerase chain reaction|
16379048|NCT00003006|Other|immunohistochemistry staining method|
16379049|NCT00067015|Drug|bicalutamide|
16379050|NCT00067015|Drug|goserelin acetate|
16379051|NCT00067015|Procedure|assessment of therapy complications|
16379052|NCT00067015|Procedure|quality-of-life assessment|
16379053|NCT00067015|Radiation|radiation therapy|
16379054|NCT00067002|Procedure|Expanded allogeneic cord blood (CB)|Transplantation of Two Unmanipulated Cord Blood Units.
16379055|NCT00067002|Procedure|One Unmanipulated and One Expanded Cord Blood Unit|Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
16379056|NCT00067002|Drug|Rituxan|375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
16379057|NCT00067002|Drug|Melphalan|140 mg/m2 by vein on Day -8.
16379058|NCT00067002|Drug|Thiotepa|5 mg/Kg by vein on Day -7.
16379059|NCT00067002|Drug|Fludarabine|40 mg/m2 by vein on Days -6 to -3.
16379060|NCT00067002|Drug|Cyclophosphamide|50 mg/kg by vein on Day -6.
16379061|NCT00067002|Drug|Mesna|10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
16379062|NCT00067002|Radiation|Total body irradiation (TBI)|Total body irradiation (TBI) given on Day -1 at 2 Gy.
16379063|NCT00066989|Drug|Staphylococcus aureus Immune Globulin (Human) 5%|
16379064|NCT00046878|Drug|O6-benzylguanine|
16379065|NCT00046878|Drug|carmustine|
16379066|NCT00002970|Drug|nelarabine|Given IV
16379067|NCT00002970|Drug|methotrexate|Given IT
16379068|NCT00002970|Drug|cytarabine|Given IT
16379069|NCT00002970|Drug|therapeutic hydrocortisone|Given IT
16379070|NCT00002621|Biological|recombinant interferon alfa|
16379071|NCT00002548|Biological|recombinant interferon alfa|"3 million units/m2 SQ Monday-Wednesday
~-Friday (3 times a week)"
16379072|NCT00002548|Drug|carmustine|20 mg/m2 I.V. day 1 q 35 days
16379073|NCT00002548|Drug|cyclophosphamide|1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)
16379074|NCT00002548|Drug|dexamethasone|40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks
16379075|NCT00002548|Drug|doxorubicin hydrochloride|10 mg/m2/day continuous 1 - 4 q 5 weeks
16379076|NCT00002548|Drug|melphalan|140 mg/m2 is given IV within 30 minutes of constitution on Day -5
16379077|NCT00002548|Drug|prednisone|40 mg/m2 PO days 1-7 q 35 days
16380704|NCT00058890|Drug|Placebo|
16379078|NCT00002548|Drug|vincristine sulfate|0.5 mg/day continuous 1 - 4 q 5 weeks
16379079|NCT00002548|Procedure|allogeneic bone marrow transplantation|day 0
16379080|NCT00002548|Procedure|autologous bone marrow transplantation|day 0
16379081|NCT00002548|Procedure|peripheral blood stem cell transplantation|day 0
16379082|NCT00002548|Radiation|radiation therapy|administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)
16379083|NCT00002520|Drug|nicotine|
16379084|NCT00002520|Behavioral|Usual Care|
16379085|NCT00066963|Device|Fluoride Varnish|0.1 mL (1 drop) applied on each of 2 arches
16379086|NCT00066950|Drug|Chlorhexidine gluconate|0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months
16379087|NCT00066950|Device|Fluoride Varnish|0.25ml FV every 6 months from age 12 to 30 months
16379088|NCT00066937|Drug|Nortriptyline Oral Capsule|Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.
16379089|NCT00066937|Drug|Benztropine Oral Product|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.
16379090|NCT00066937|Behavioral|CBT|Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.
16379091|NCT00066937|Behavioral|Disease MGT|Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
16379092|NCT00066898|Drug|AGI-1067|
16379093|NCT00066885|Drug|calcitriol + docetaxel|
16379094|NCT00011973|Drug|fenretinide|
16379095|NCT00005027|Drug|becatecarin|
16379096|NCT00066872|Drug|imiquimod|
16379097|NCT00066872|Procedure|conventional surgery|
16379098|NCT00066859|Drug|Zoloft 50 mg|Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
16379099|NCT00066859|Dietary Supplement|St. John's Wort 600 mg|St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
16379100|NCT00066846|Biological|bevacizumab|
16379101|NCT00066846|Drug|fluorouracil|
16379102|NCT00066846|Drug|leucovorin calcium|
16379103|NCT00066807|Drug|chemotherapy|Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given.
16379104|NCT00066807|Drug|exemestane|Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
16379105|NCT00066807|Drug|tamoxifen|Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
16379106|NCT00066807|Drug|triptorelin|Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.
16379107|NCT00066807|Procedure|oophorectomy|Bilateral surgical oophorectomy via laparotomy or laparoscopy.
16379108|NCT00066807|Procedure|ovarian irradiation|Bilateral ovarian irradiation.
16379109|NCT00066794|Biological|filgrastim|5 mcg/kg/d IV or SC starting apx day 15
16379110|NCT00066794|Biological|sargramostim|250 mcg/kg/d IV or SC starting apx day 15
16379111|NCT00066794|Drug|cyclosporine|ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50
16379112|NCT00066794|Drug|cytarabine|ind: 200 mg/m2/d cont IV days 2-74
16379113|NCT00066794|Drug|daunorubicin hydrochloride|ind: 45 mg/m2/d cont IV days 2-74
16379114|NCT00066781|Drug|gemcitabine hydrochloride|Given IV
16379115|NCT00066781|Drug|irinotecan hydrochloride|Given IV
16379116|NCT00066768|Drug|suramin|Given IV
16379117|NCT00066768|Drug|docetaxel|Given IV
16379118|NCT00066768|Drug|gemcitabine hydrochloride|Given IV
16379119|NCT00066768|Other|laboratory biomarker analysis|Correlative studies
16379120|NCT00066768|Other|pharmacological study|Correlative studies
16379121|NCT00066742|Drug|tirapazamine|Given IV
16379122|NCT00066742|Drug|cisplatin|Given IV
16379123|NCT00066742|Drug|etoposide|Given IV
16379124|NCT00066742|Radiation|radiation therapy|Undergo radiation therapy
16379125|NCT00066742|Other|laboratory biomarker analysis|Correlative studies
16379126|NCT00066729|Biological|NY-ESO-1 peptide vaccine|NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51
16379127|NCT00066716|Drug|carboplatin|Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
16379128|NCT00066716|Drug|celecoxib|400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented.
16379129|NCT00066716|Drug|paclitaxel|200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
16379130|NCT00066716|Procedure|adjuvant therapy|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
~Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year."
16379131|NCT00066716|Procedure|conventional surgery|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection."
16379199|NCT00066391|Procedure|neoadjuvant therapy|
16379200|NCT00066378|Drug|anastrozole|
16379201|NCT00066378|Drug|gefitinib|
16379132|NCT00066716|Procedure|neoadjuvant therapy|"Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
~Operation will be performed within 6-12 hours from the last dose of celecoxib.
~Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection."
16379133|NCT00066703|Drug|exemestane|
16379134|NCT00066703|Drug|tamoxifen|
16379135|NCT00066703|Drug|triptorelin|
16379136|NCT00066690|Drug|Exemestane|Exemestane 25mg orally daily for 5 years plus ovarian function suppression
16379137|NCT00066690|Other|Laboratory Biomarker Analysis|Correlative studies
16379138|NCT00066690|Procedure|Oophorectomy|Undergo bilateral surgical oophorectomy
16379139|NCT00066690|Other|Quality-of-Life Assessment|Ancillary studies
16379140|NCT00066690|Radiation|Radiation Therapy|Undergo ovarian irradiation
16379141|NCT00066690|Drug|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
16379142|NCT00066690|Drug|Triptorelin|3.75 mg by im injection q28 days for 5 years
16379143|NCT00066677|Drug|rhuMAB-VEGF|
16379144|NCT00066677|Drug|docetaxel|
16379145|NCT00066664|Genetic|proteomic profiling|
16379146|NCT00066651|Biological|SS1(dsFv)-PE38 immunotoxin|
16379147|NCT00066638|Drug|Romidepsin|Given IV
16379148|NCT00066638|Other|Laboratory Biomarker Analysis|Correlative studies
16379149|NCT00066625|Drug|oxaliplatin|Given IV
16379150|NCT00066625|Drug|bortezomib|Given IV
16379151|NCT00066625|Other|laboratory biomarker analysis|Correlative studies
16379152|NCT00066625|Other|pharmacological study|Correlative studies
16379153|NCT00066612|Drug|irinotecan hydrochloride|Irinotecan will be given 250 mg/m^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs
16379154|NCT00066599|Drug|voriconazole|
16379155|NCT00066586|Drug|exemestane|exemestane 25 mg once daily x 1 year
16379156|NCT00066586|Drug|Placebo|placebo once daily x 1 year
16379157|NCT00066573|Drug|anastrozole|Given orally
16379158|NCT00066573|Drug|exemestane|Given orally
16379159|NCT00066547|Biological|monoclonal antibody HuHMFG1|
16379160|NCT00066508|Drug|bortezomib|
16379161|NCT00066482|Biological|bleomycin sulfate|Given IV over 10 minutes. Children ≥ 12 months: 15 units/m2/dose Children < 12 months: 0.5 units/kg/dose Day 1 (Week 1, 4, 7, 10)
16379162|NCT00066482|Biological|filgrastim|Given SQ once daily 5 micrograms/kg/dose Starting on Day 6 (Week 1, 4, 7, 10) Daily until ANC > 5,000/uL
16379163|NCT00066482|Drug|cisplatin|Children ≥ 12 months: Given IV over one hour Dose: 20 mg/m2/dose Days 1-5 (Week 1,4,7,10) Children < 12 months: Given IV over 4 hours, 0.67 mg/kg/dose Days 1-5 (Week 1,4,7,10)
16379164|NCT00066482|Drug|cyclophosphamide|Given IV over 1 hour. Children ≥ 12 months: Level 1: 1.2 g/m2/dose Level 2: 1.8 g/m2/dose Level 3: 2.4 g/m2/dose Children < 12 months: Level 1: 40 mg/kg/dose Level 2: 60 mg/kg/dose Level 3: 80 mg/kg/dose Day 1 (Week 1, 4, 7, 10)
16379165|NCT00066482|Drug|etoposide|Given IV over 1 hour. Children ≥ 12 months: 100 mg/m2/dose Children < 12 months: 3.3 mg/kg/dose Day 1-5 (Week 1, 4, 7, 10)
16379166|NCT00066482|Procedure|conventional surgery|Stage III/IV extragonadal tumors: biopsy followed by a definitive surgical excision after maximal chemotherapy effect, likely after 4 cycles of therapy
16379167|NCT00066482|Biological|MESNA|Given IV or oral. The total daily MESNA dose is equal to at least 80% of the daily CPM dose. The oral dose of MESNA is 2x the IV dose. Day 1 (Week 1,4,7,10) To be given with CPM.
16379168|NCT00066469|Biological|rituximab|Cycles 1 and 2 only: Given IV Incremental: First dosage: < 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: < 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.
16379169|NCT00066469|Drug|cyclophosphamide|Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle
16379170|NCT00066469|Drug|methylprednisolone|Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.
16379171|NCT00066469|Drug|prednisone|Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size
16379172|NCT00066456|Radiation|3-Dimensional Conformal Radiation Therapy|
16379173|NCT00066456|Drug|Chemosensitization/Potentiation Therapy|
16379174|NCT00066456|Drug|Docetaxel|Given IV
16379175|NCT00066443|Biological|pegfilgrastim|Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2
16379176|NCT00066443|Drug|docetaxel|Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2
16379177|NCT00066443|Drug|epirubicin hydrochloride|Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV
16379178|NCT00066430|Procedure|infrared photocoagulation therapy|
16379179|NCT00066430|Device|Infrared Coagulator|IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.
16379180|NCT00066417|Drug|cyclophosphamide|
16379181|NCT00066417|Drug|cyclosporine|
16379182|NCT00066417|Drug|fludarabine phosphate|
16379183|NCT00066417|Drug|methylprednisolone|
16379184|NCT00066417|Drug|therapeutic allogeneic lymphocytes|
16379185|NCT00066417|Drug|thiotepa|
16379186|NCT00066417|Procedure|allogeneic bone marrow transplantation|
16379187|NCT00066417|Procedure|biological therapy|
16379188|NCT00066417|Procedure|bone marrow ablation with stem cell support|
16379189|NCT00066417|Procedure|bone marrow transplantation|
16379190|NCT00066417|Procedure|chemotherapy|
16379191|NCT00066417|Procedure|leukocyte therapy|
16379192|NCT00066417|Procedure|non-specific immune-modulator therapy|
16379193|NCT00066417|Procedure|peripheral blood lymphocyte therapy|
16379194|NCT00066417|Procedure|peripheral blood stem cell transplantation|
16379195|NCT00066417|Procedure|radiation therapy|
16379196|NCT00066404|Biological|recombinant adenovirus-hIFN-beta|
16379197|NCT00066391|Drug|cisplatin|
16379198|NCT00066391|Drug|irinotecan hydrochloride|
16379202|NCT00066365|Biological|sargramostim|given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
16379203|NCT00066365|Procedure|conventional surgery|thoracotomy
16379204|NCT00066352|Drug|bortezomib|
16379205|NCT00066339|Drug|gefitinib|
16379206|NCT00066326|Drug|imatinib mesylate|
16379207|NCT00066326|Drug|tanespimycin|
16379208|NCT00066313|Drug|vandetanib|
16379209|NCT00066313|Procedure|adjuvant therapy|
16379210|NCT00066274|Drug|FOLFIRI regimen|
16379211|NCT00066274|Drug|FOLFOX regimen|
16379212|NCT00066274|Drug|fluorouracil|
16379213|NCT00066274|Drug|irinotecan hydrochloride|
16379214|NCT00066274|Drug|leucovorin calcium|
16379215|NCT00066274|Drug|oxaliplatin|
16379216|NCT00066248|Drug|cyproheptadine hydrochloride|Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
16379217|NCT00066248|Drug|megestrol acetate|Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
16379218|NCT00066222|Drug|Cisplatin|60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.
16379219|NCT00066222|Drug|Etoposide|120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.
16379220|NCT00066222|Radiation|Radiation therapy|Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
16379221|NCT00066196|Biological|MEDI--522|IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
16379222|NCT00066196|Biological|Integrin + Dacarbazine|supplied in other formulations
16379223|NCT00020462|Biological|aldesleukin|
16379224|NCT00020462|Biological|autologous tumor cell vaccine|
16379225|NCT00019721|Biological|MART-1 antigen|
16379226|NCT00019721|Biological|aldesleukin|
16379227|NCT00019721|Biological|gp100 antigen|
16379228|NCT00019721|Biological|incomplete Freund's adjuvant|
16379229|NCT00019383|Biological|aldesleukin|
16379230|NCT00019383|Biological|incomplete Freund's adjuvant|
16379231|NCT00019383|Biological|sargramostim|
16379232|NCT00019383|Biological|tyrosinase peptide|
16379233|NCT00019383|Biological|tyrosinase-related protein-1|
16379234|NCT00066170|Drug|Xyrem|Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
16379235|NCT00066170|Drug|Xyrem Placebo|Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
16379236|NCT00066170|Drug|Modafinil at established dose|Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
16379237|NCT00066170|Drug|Modafinil (Placebo)|Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
16379238|NCT00033722|Dietary Supplement|folic acid|
16379239|NCT00033722|Drug|lometrexol|
16379240|NCT00033306|Drug|ixabepilone|
16379241|NCT00033306|Drug|Fluoropyrimidine|
16379242|NCT00033306|Drug|Irinotecan|
16379243|NCT00031811|Drug|raloxifene|
16379244|NCT00031811|Procedure|quality-of-life assessment|
16379245|NCT00031785|Drug|megestrol acetate|
16379246|NCT00031785|Radiation|radiation therapy|
16379247|NCT00066157|Drug|Transdermal estradiol|50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months
16379248|NCT00066157|Drug|Medroxyprogesterone|2.5mg tablet daily for 12 months
16379249|NCT00066157|Drug|Placebo Patch|Transdermal placebo patch, changed every 3 days, for 12 months
16379250|NCT00066157|Drug|Placebo|Placebo tablet daily for 12 months
16379251|NCT00066144|Drug|Cimicifuga racemosa|
16379252|NCT00066144|Drug|Trifolium pratense|
16379253|NCT00066144|Drug|Black cohosh|
16379254|NCT00066144|Drug|Red clover|
16379255|NCT00066131|Procedure|Periodontal scaling and root planing|Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.
16379256|NCT00066131|Procedure|Scaling and root planing|Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.
16379257|NCT00066118|Device|Dental amalgam restorations|
16379258|NCT00066092|Drug|pegfilgrastim 12 mg|Pegfilgrastim 12 mg given once for PBPC mobilization
16379259|NCT00066092|Drug|filgrastim|Filgrastim given daily for PBPC mobilization
16379260|NCT00066092|Drug|pegfilgrastim 6 mg|Pegfilgrastim 6 mg given once for PBPC mobilization
16379261|NCT00066079|Procedure|massage|
16379262|NCT00066079|Behavioral|relaxation|
16379263|NCT00066066|Procedure|Scaling and root planing|Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
16379264|NCT00066066|Drug|Metronidazole|Metronidazole (MET) is an antibiotic that is particularly effective against Gram negative bacterial species. The dose for this study is: 250 mg tid x 14d.
16379265|NCT00066066|Drug|Amoxicillin|Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
16379328|NCT00065546|Other|Placebo plus choline depletion diet|Post-menopausal women are randomized to receive a placebo and are then subjected to a low choline diet to determine if clinical signs of choline deficiency can be induced.
16379329|NCT00065546|Other|Pre-menopausal women with SNPs given a low choline diet|Pre-menopausal women with specific genetic polymorphisms in genes related to choline metabolism are placed on a choline depletion diet to determine if the SNPs increase or decrease the risk of diet-induced choline deficiency.
16379330|NCT00065637|Drug|Teriparatide|Synthetic human parathyroid hormone
16379331|NCT00065637|Drug|Placebo teriparatide|Placebo injections
16379266|NCT00066066|Drug|Doxycycline|The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
16379267|NCT00066053|Procedure|Periodontal Treatment: SRP|Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
16379268|NCT00066053|Procedure|Referral|
16379269|NCT00066040|Drug|Cervitec chlorhexidine varnish|
16379270|NCT00066040|Drug|Duraphat fluoride varnish|
16379271|NCT00066040|Drug|xylitol gum from Fennobon, Finland|
16379272|NCT00066027|Drug|20 mg doxycycline hyclate|Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
16379273|NCT00066027|Drug|Placebo|Subjects in the placebo group took a placebo look-alike twice daily for two years.
16379274|NCT00066014|Procedure|Implant Overdenture Treatment|All overdenture treatment modalities were provided to each subject using a crossover design.
16379275|NCT00066001|Drug|metronidazole|antibiotic that is particularly effective against Gram negative bacterial species
16379276|NCT00065988|Device|Dispersed phase amalgam restoration /composite restoration|
16379277|NCT00065975|Procedure|massage therapy|
16379278|NCT00065975|Procedure|chiropractic|
16379279|NCT00065975|Procedure|acupuncture|
16379280|NCT00065962|Drug|secretin, synthetic porcine|
16379281|NCT00065962|Drug|secretin, biologically derived porcine|
16379282|NCT00065949|Drug|magnesium sulfate|
16379283|NCT00065936|Drug|Naltrexone hydrochloride|
16379284|NCT00065936|Procedure|Transcutaneous sensory nerve stimulation|
16379285|NCT00065923|Drug|Topiramate|
16379286|NCT00065910|Behavioral|Caregiver joint attention intervention|
16379287|NCT00065897|Procedure|Amniocentesis|
16379288|NCT00065897|Procedure|Transabdominal chorionic villus sampling (TA CVS)|
16379289|NCT00065884|Drug|Valproate|
16379290|NCT00065871|Behavioral|Contraceptive Screening by Pharmacist|
16379291|NCT00065871|Behavioral|Contraceptive Prescribing by Pharmacist|
16379292|NCT00065858|Drug|BufferGel|
16379293|NCT00065845|Procedure|Burch urethropexy at time of sacrocolpopexy|The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
16379294|NCT00031707|Dietary Supplement|eicosapentaenoic acid|
16379295|NCT00031707|Drug|megestrol acetate|
16379296|NCT00031707|Other|placebo|
16379297|NCT00026273|Drug|FOLFIRI regimen|
16379298|NCT00026273|Drug|fluorouracil|
16379299|NCT00026273|Drug|irinotecan hydrochloride|
16379300|NCT00026273|Drug|leucovorin calcium|
16379301|NCT00025688|Drug|carboplatin|
16379302|NCT00025688|Drug|paclitaxel|
16379303|NCT00024024|Drug|rebimastat|
16379304|NCT00022477|Drug|BMS-247550|
16379305|NCT00065832|Behavioral|Reading Instruction|
16379306|NCT00065819|Behavioral|HIV Symptom Education Program|
16379307|NCT00065806|Drug|Atorvastatin|Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.
16379308|NCT00065806|Drug|Placebo atorvastatin|Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.
16379309|NCT00065767|Drug|Raloxifene|
16379310|NCT00065754|Drug|placebo|
16379311|NCT00065741|Drug|silymarin|
16379312|NCT00065728|Drug|Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL|One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
16379313|NCT00065715|Dietary Supplement|Echinacea|Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet
16379314|NCT00065715|Other|Blinded placebo|Blinded placebo - Coated tablet
16379315|NCT00065702|Drug|Active liquid remedy|
16379316|NCT00065689|Device|high-intensity light therapy|
16379319|NCT00065663|Genetic|GAM501|
16379320|NCT00065650|Drug|Vedic Medicine|
16379321|NCT00065650|Behavioral|Vedic Medicine|
16379322|NCT00065624|Drug|lipoic acid|
16379323|NCT00065585|Procedure|Accupuncture|
16379324|NCT00065572|Drug|ZD6126|
16379325|NCT00065572|Drug|Placebo|
16379326|NCT00065559|Drug|celecoxib|
16379327|NCT00065546|Other|Estrogen plus choline depletion diet|Post-menopausal subjects receive estrogen and are then challenged with a low choline diet to determine if estrogen protects them from induction of choline deficiency.
16379332|NCT00014560|Biological|bispecific antibody 4G7xH22|
16379333|NCT00014560|Biological|sargramostim|
16379334|NCT00014261|Biological|PEG-interferon alfa-2b|
16379335|NCT00014261|Drug|temozolomide|
16379336|NCT00014248|Drug|adenosine triphosphate|
16379337|NCT00014248|Procedure|quality-of-life assessment|
16379338|NCT00014209|Drug|cisplatin|
16379339|NCT00014209|Drug|dexamethasone|
16379340|NCT00014209|Drug|gemcitabine hydrochloride|
16379341|NCT00010127|Biological|therapeutic autologous dendritic cells|
16379342|NCT00065611|Drug|Oral dexamethasone|"Stage I: Dexamethasone 25 mg/m2, 2 doses every 2 weeks over 48 weeks or dexamethasone 25 mg/m2, 4 doses every 4 weeks over 48 weeks.
~Stage II: 1.) Dexamethasone 50 mg/m2, 2 daily doses every 12 weeks, followed by 25 mg/m2, 2 daily doses every 2 weeks over 36 weeks, or 2.) Dexamethasone 50 mg/m2, 4 daily doses every 4 weeks over 12 weeks, followed by 25 mg/m2, 4 daily doses every 4 weeks over 36 weeks.
~over 36 weeks."
16379343|NCT00065533|Drug|pemetrexed|
16379344|NCT00065507|Drug|Entecavir (ETV)|Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized
16379345|NCT00065507|Drug|Adefovir (ADV)|Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
16379346|NCT00006799|Drug|megestrol acetate|
16379347|NCT00006799|Procedure|quality-of-life assessment|
16379348|NCT00006486|Drug|carboxyamidotriazole|Given orally
16379349|NCT00006486|Other|placebo|Given orally
16379350|NCT00006453|Drug|carboplatin|
16379351|NCT00006453|Drug|gemcitabine hydrochloride|
16379352|NCT00006352|Biological|BCG vaccine|
16379353|NCT00006352|Biological|monoclonal antibody BEC2|
16379354|NCT00006240|Biological|sargramostim|
16379355|NCT00006240|Drug|dexamethasone|
16379356|NCT00006240|Drug|oral sodium phenylbutyrate|
16379357|NCT00065468|Drug|Interferon Alfa|Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
16379358|NCT00065468|Drug|CCI-779|25 mg of CCI-779 given Intra Venously once per week
16379359|NCT00065468|Drug|Interferon Alfa and CCI-779|15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
16379360|NCT00006229|Drug|carboplatin|
16379361|NCT00006229|Drug|paclitaxel|
16379362|NCT00006229|Drug|rebimastat|
16379363|NCT00006081|Drug|Bryostatin-1|40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).
16379364|NCT00006081|Drug|Paclitaxel (Taxol)|80 mg/m^2 one-hour infusion weekly x 3 every 4 weeks
16379365|NCT00065455|Drug|Vitamin A|
16379366|NCT00065442|Biological|Sipuleucel-T|Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
16379367|NCT00065442|Biological|APC-Placebo|Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
16379368|NCT00065429|Drug|BB-10901|"I.V. Infusion - See Arms for dosage - Once/Week for three weeks - Until Progression of disease."
16379369|NCT00005604|Biological|recombinant interleukin-12|Given IV
16379370|NCT00005604|Biological|aldesleukin|Given SC
16379371|NCT00005604|Other|laboratory biomarker analysis|Correlative studies
16379372|NCT00004887|Drug|carboplatin|
16379373|NCT00004887|Drug|cisplatin|
16379374|NCT00004887|Drug|ifosfamide|
16379375|NCT00004887|Drug|mitomycin C|
16379376|NCT00004887|Drug|paclitaxel|
16379377|NCT00004887|Drug|vinblastine sulfate|
16379378|NCT00065416|Procedure|massage|
16379379|NCT00065403|Device|Acupuncture|
16379380|NCT00065364|Behavioral|Newborn Individualized Developmental Care Assessment Program|
16379381|NCT00065351|Drug|CC-5013|CC-5013 - oral - 30mg daily on days 1-21 every 28 days
16379382|NCT00065338|Behavioral|Exercise and behavior modification|Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.
16379383|NCT00065325|Drug|Fulvestrant|intramuscular injection
16379384|NCT00065325|Drug|Exemestane|oral capsule
16379385|NCT00004253|Drug|carboplatin|
16379386|NCT00004253|Drug|paclitaxel|
16379387|NCT00004253|Radiation|radiation therapy|
16379388|NCT00065390|Drug|Pyrimethamine|
16379389|NCT00065377|Drug|Glucosamine Hydrochloride|
16379390|NCT00065312|Drug|naveglitazar|
16379391|NCT00065299|Behavioral|Restricted phenylalanine diet|
16379392|NCT00065273|Drug|risperidone|
16379393|NCT00065273|Drug|clozapine|
16379394|NCT00065273|Drug|olanzapine|
16379395|NCT00065247|Behavioral|Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project|
16379396|NCT00065234|Procedure|Acupuncture|
16379397|NCT00065221|Drug|Ginger|
16379398|NCT00065208|Behavioral|Reiki|Energy therapy - 8 biweekly sessions of 30 minutes
16379399|NCT00065208|Behavioral|Pretend Reiki|Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes
16379400|NCT00065208|Behavioral|Rest / Guided Imagery|4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)
16379401|NCT00065260|Drug|Campath-1H|Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day).
16379402|NCT00065260|Drug|r-ATG|Rabbit ATG 3.5mg/kg/day for consecutive 5 days
16379403|NCT00065260|Drug|CsA|CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs.
16379404|NCT00065195|Procedure|Moving touch therapy|
16379405|NCT00065195|Procedure|Nonmoving touch therapy|
16379406|NCT00065182|Drug|Topotecan/Docetaxel combination|
16379407|NCT00065182|Drug|Docetaxel|
16379408|NCT00065169|Drug|Celecoxib|
16379530|NCT00064363|Drug|talampanel|
16379618|NCT00063934|Biological|oblimersen sodium|Given IV
16379409|NCT00065156|Drug|lenalidomide|10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen.
16379410|NCT00065143|Drug|clofarabine|
16379411|NCT00065143|Drug|Ara-C|
16379412|NCT00065130|Drug|human insulin|
16379413|NCT00065130|Drug|insulin NPH|
16379414|NCT00065130|Drug|insulin aspart|
16379415|NCT00065117|Drug|ZD6126|
16379416|NCT00065117|Drug|Placebo|
16379417|NCT00065117|Drug|5-fluorouracil|
16379418|NCT00065117|Drug|leucovorin|
16379419|NCT00065117|Drug|oxaliplatin|
16379420|NCT00065104|Drug|DHEA|
16379421|NCT00065078|Procedure|Home dispensing of contraception|
16379422|NCT00065065|Drug|Rosiglitazone|4mg orally twice daily for 12 weeks
16379423|NCT00065065|Drug|Placebo|pill that looks identical to rosiglitazone
16379424|NCT00065052|Behavioral|Behavior modification|
16379425|NCT00065039|Behavioral|Promotion of a healthy diet and physical activity|
16379426|NCT00065039|Behavioral|Avoidance of Alcohol, Drugs, and Tobacco|
16379427|NCT00065026|Behavioral|Physical activity opportunities for low-income women|
16379428|NCT00065013|Behavioral|strength training|
16379429|NCT00065000|Behavioral|Water, Cafeteria and Staff Health Promotion|
16379430|NCT00004204|Drug|temozolomide|
16379431|NCT00004006|Biological|filgrastim|
16379432|NCT00004006|Drug|carboplatin|
16379433|NCT00004006|Drug|cyclophosphamide|
16379434|NCT00004006|Drug|doxorubicin hydrochloride|
16379435|NCT00004006|Drug|etoposide|
16379436|NCT00004006|Drug|topotecan hydrochloride|
16379437|NCT00004006|Procedure|autologous bone marrow transplantation|
16379438|NCT00004006|Radiation|radiation therapy|
16379439|NCT00003895|Biological|HPV 16 E7:12-20|Given SC
16379440|NCT00003895|Biological|gp100:209-217(210M)|Given SC
16379441|NCT00003895|Other|laboratory biomarker analysis|Correlative studies
16379442|NCT00003795|Procedure|quality-of-life assessment|
16379443|NCT00003759|Biological|BCG vaccine|
16379444|NCT00003759|Drug|valrubicin|
16379445|NCT00003759|Procedure|conventional surgery|
16379446|NCT00064987|Procedure|Testicular biopsy|Outpatient surgical procedure.
16379447|NCT00064987|Drug|gonadotropin releasing hormone (GnRH)|Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)
16379448|NCT00064987|Drug|follicle stimulating hormone (FSH)|75 IU subcutaneous injection daily for four months.
16379449|NCT00064974|Drug|CC-5013|CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
16379450|NCT00064961|Behavioral|Individualized dietary-control and exercise program|
16379451|NCT00064961|Behavioral|Weight-management and smoking cessation maintenance|
16379452|NCT00064961|Behavioral|Smoking Cessation program|
16379453|NCT00064935|Procedure|Endometrial biopsy|
16379454|NCT00064922|Behavioral|Behavior Therapy|
16379455|NCT00064857|Drug|Pycnogenol|
16379456|NCT00064896|Procedure|MRI|
16379457|NCT00064844|Behavioral|Cognitive Behavior Therapy for alcohol and smoking cessation|Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.
16379458|NCT00064844|Drug|Nicoderm CQ nicotine patch|Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy.
16379459|NCT00064844|Drug|Placebo gum|Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks.
16379460|NCT00064844|Drug|Nicotine gum - Nicorette®|Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.
16379461|NCT00064831|Drug|Black Cohosh Extract (BCE)|
16379462|NCT00064805|Behavioral|Cognitive Therapy to Improve Reading|
16379463|NCT00064779|Drug|IL13-PE38QQR|
16379464|NCT00064779|Procedure|targeted fusion protein therapy|
16379465|NCT00064779|Procedure|surgery|
16379466|NCT00064766|Drug|doxycycline|
16379467|NCT00064753|Drug|High Dose Multivitamin|Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
16379468|NCT00064753|Device|Low Dose Multivitamin|Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
16379613|NCT00063960|Drug|irinotecan hydrochloride|
16379614|NCT00063947|Drug|erlotinib hydrochloride|Given orally
16379615|NCT00063947|Drug|gemcitabine hydrochloride|Given IV
16379616|NCT00063947|Radiation|radiation therapy|Undergo radiotherapy
16379617|NCT00063947|Other|laboratory biomarker analysis|Correlative studies
16382106|NCT00046969|Drug|cisplatin|
16379469|NCT00003712|Drug|temsirolimus|"•Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
~The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.
~•Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II."
16379470|NCT00003707|Drug|gemcitabine hydrochloride|
16379471|NCT00003707|Drug|tipifarnib|
16379472|NCT00003645|Drug|Flutamide|10.8 mg intramuscularly once every 3 months for 12 months
16379473|NCT00003645|Drug|Leuprolide Acetate|50 mg tablet orally daily for 12 months
16379474|NCT00003571|Genetic|mutation analysis|
16379475|NCT00003571|Genetic|tumor replication error analysis|
16379476|NCT00003382|Biological|filgrastim|
16379477|NCT00003382|Drug|gemcitabine hydrochloride|
16379478|NCT00003382|Drug|topotecan hydrochloride|
16379479|NCT00064792|Drug|Simvastatin Susp.|During the simvastatin phase of the trial, therapy will be initiated at 0.5 mg/kg/day for six weeks and then increased to 1.0 mg/kg/day if adverse side effects are minimal or absent.
16379480|NCT00064792|Drug|OraPlus|During this trial and for two months prior, patients will be maintained on 150 mg/kg/day of dietary cholesterol (150 mg/ml in OraPlus) for the duration of the trial
16379481|NCT00064740|Behavioral|relaxation response|
16379482|NCT00064701|Drug|Tacrolimus Modified Release (MR)|The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.
16379483|NCT00064701|Drug|Tacrolimus|The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.
16379484|NCT00064701|Drug|cyclosporine microemulsion|The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.
16379485|NCT00064701|Drug|mycophenolate mofetil|Oral
16379486|NCT00064727|Drug|Avandia (Rosiglitazone)|
16379487|NCT00064727|Drug|Avanclia (Rosiqlitazone)|
16379488|NCT00064714|Drug|AC2993 (exenatide)|Dose-escalation beginning with 2.5 μg administered subcutaneously twice per day (BID); then to 2.5 μg four times a day (QID); then to 5 μg four times a day; then to 10 μg four times a day.
16379489|NCT00064714|Drug|daclizumab (immunosuppressive)|2 mg/kg intravenously infused over 30 minutes every month for 12 months
16379490|NCT00064662|Procedure|Burch Modified Tanagho|The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.
16379491|NCT00064662|Procedure|Autologous Fascia Sling|The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures
16379492|NCT00064649|Device|Transurethral Microwave Thermotherapy (TUMT)|type of minimally invasive surgical therapy for BPH
16379493|NCT00064649|Device|Transurethral Needle Ablation (TUNA) Therapy|type of minimally invasive surgical therapy for BPH
16379494|NCT00064649|Drug|Finasteride and Alfuzosin|finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
16379495|NCT00064636|Drug|VELCADE TM (bortezomib) for Injection, or PS-341|
16379496|NCT00064623|Drug|Capsaicin Dermal Patch|
16379497|NCT00064610|Drug|VELCADE TM (bortezomib) for Injection|
16379498|NCT00063726|Drug|bortezomib|
16379499|NCT00003350|Drug|paclitaxel|Given IV
16379500|NCT00003350|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16379501|NCT00003350|Other|laboratory biomarker analysis|Correlative studies
16379502|NCT00003350|Procedure|quality-of-life assessment|Ancillary studies
16379503|NCT00003184|Biological|BCG vaccine|
16379504|NCT00003184|Biological|CD80 breast cancer vaccine|
16379505|NCT00003184|Biological|sargramostim|
16379506|NCT00003045|Device|Hyperthermia|Hyperthermia is delivered by the transrectal ultrasound applicator just prior to XRT, at least one week apart, during the first 4 weeks of XRT. The goal of hyperthermia is CEM T 90 43 greater than or equal to 10 minutes. The maximum applied power duration will be 120 minutes per treatment session
16379507|NCT00003045|Radiation|XRT|external beam radiation to a dose of 4500 cGy to a small pelvic field, followed by a boost to a reduced volume for an additional 2160 cGy. XRT is given daily, 5 days a week for 180 cGy per day. Total radiation dose=6660cGy
16379508|NCT00003008|Drug|indinavir sulfate|
16379509|NCT00003008|Drug|nelfinavir mesylate|
16379510|NCT00003008|Drug|paclitaxel|
16379511|NCT00003008|Drug|ritonavir|
16379512|NCT00003008|Drug|saquinavir mesylate|
16379513|NCT00002965|Biological|Recombinant Interferon Alfa (INF alpha)|Subcutaneous injection Monday through Friday for 8 weeks.
16379514|NCT00064584|Drug|CT53518|
16379515|NCT00064571|Procedure|vocal fold medialization|
16379516|NCT00064571|Procedure|vocal fold reinnervation|
16379517|NCT00064467|Drug|Extended-release bupropion (HCl)|
16379518|NCT00064454|Drug|OPC-6535 Tablets (drug)|
16379519|NCT00064441|Drug|OPC-6535 Tablets (drug)|
16379520|NCT00064415|Drug|arformoterol|Arformoterol inhalation solution, 50 mcg QD
16379521|NCT00064415|Drug|Salmeterol|Salmeterol MDI, 42 mcg BID
16379522|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 50 mcg QD
16379523|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 25 mcg BID
16379524|NCT00064402|Drug|arformoterol tartrate inhalation solution|arformoterol 15 mcg BID
16379525|NCT00064402|Drug|Salmeterol|Salmeterol MDI 42 mcg BID
16379526|NCT00064402|Drug|Placebo|Placebo BID
16379527|NCT00064389|Drug|levalbuterol tartrate HFA MDI|levalbuterol MDI 90 mcg QID
16379528|NCT00064389|Drug|racemic albuterol|racemic albuterol HFA MDI 180 mcg QID
16379529|NCT00064376|Drug|paricalcitol|
16379531|NCT00064350|Drug|Sorafenib|"Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.
~Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.
~Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death."
16379532|NCT00064350|Drug|Placebo|Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).
16379533|NCT00064337|Biological|filgrastim|
16379534|NCT00064337|Drug|cyclophosphamide|
16379535|NCT00064337|Drug|dexamethasone|
16379536|NCT00064337|Drug|melphalan|
16379537|NCT00064337|Drug|thalidomide|
16379538|NCT00064337|Procedure|peripheral blood stem cell transplantation|
16379539|NCT00064324|Drug|perifosine|Given orally
16379540|NCT00064324|Other|laboratory biomarker analysis|Correlative studies
16379541|NCT00064324|Other|pharmacological study|Correlative studies
16379542|NCT00064311|Drug|ravuconazole|
16379543|NCT00064298|Dietary Supplement|fruit and vegetable extracts|Given orally
16379544|NCT00064298|Dietary Supplement|placebo|Given orally
16379545|NCT00064285|Drug|alvocidib|
16379546|NCT00064285|Drug|imatinib mesylate|
16379547|NCT00064272|Drug|ginger extract|Given orally
16379548|NCT00064272|Other|placebo|Given orally
16379549|NCT00064259|Biological|oblimersen sodium|Given IV
16379550|NCT00064259|Drug|cisplatin|Given IV
16379551|NCT00064259|Drug|fluorouracil|Given IV
16379552|NCT00064246|Biological|rituximab|Given IV
16379553|NCT00064246|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
16379554|NCT00064246|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16379555|NCT00064233|Drug|dasatinib|
16379556|NCT00064220|Drug|soblidotin|
16379557|NCT00064207|Drug|gemcitabine hydrochloride|
16379558|NCT00064207|Procedure|adjuvant therapy|
16379559|NCT00064207|Radiation|radiation therapy|
16379560|NCT00064194|Dietary Supplement|selenium|
16379561|NCT00064194|Dietary Supplement|soy protein isolate|
16379562|NCT00064194|Dietary Supplement|vitamin E|
16379563|NCT00064181|Drug|FOLFIRI regimen|
16379564|NCT00064181|Drug|capecitabine|
16379565|NCT00064181|Drug|celecoxib|
16379566|NCT00064181|Drug|fluorouracil|
16379567|NCT00064181|Drug|irinotecan hydrochloride|
16379568|NCT00064181|Drug|leucovorin calcium|
16379569|NCT00064142|Drug|halofuginone hydrobromide|Applied topically
16379570|NCT00064142|Other|placebo|Applied topically
16379571|NCT00064142|Other|laboratory biomarker analysis|Correlative studies
16379572|NCT00064142|Other|pharmacological study|Correlative studies
16379573|NCT00064129|Biological|Ipilimumab|Given IV
16379574|NCT00064129|Other|Laboratory Biomarker Analysis|Correlative studies
16379575|NCT00064129|Other|Pharmacological Study|Correlative studies
16379576|NCT00064129|Biological|Sargramostim|Given SC
16379577|NCT00064116|Biological|rituximab|Rituximab 375 mg/m² i.v. day 1
16379578|NCT00064116|Drug|CHOP regimen|Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6
16379579|NCT00064103|Biological|Ad5CMV-p53 gene|Given intramucosally or as oral rinse
16379580|NCT00064103|Other|laboratory biomarker analysis|Correlative studies
16379581|NCT00064090|Drug|cytarabine|
16379582|NCT00064090|Drug|triapine|
16379583|NCT00064077|Drug|Cisplatin|Given IV
16379584|NCT00064077|Drug|Gemcitabine Hydrochloride|
16379585|NCT00064077|Drug|Paclitaxel|Given IV
16379586|NCT00064077|Other|Quality-of-Life Assessment|Ancillary studies
16379587|NCT00064077|Drug|Topotecan Hydrochloride|Given IV
16379588|NCT00064077|Drug|Vinorelbine Tartrate|Given IV
16379589|NCT00064064|Drug|gemcitabine hydrochloride|
16379590|NCT00064064|Drug|triapine|
16379591|NCT00064051|Drug|gemcitabine hydrochloride|
16379592|NCT00064051|Drug|triapine|
16379593|NCT00064038|Drug|dexamethasone|Given orally
16379594|NCT00064038|Drug|lenalidomide|Given orally
16379595|NCT00064038|Other|placebo|Given orally
16379596|NCT00064025|Other|Laboratory Biomarker Analysis|Correlative studies
16379597|NCT00064025|Drug|Medroxyprogesterone|Given IM
16379598|NCT00064025|Procedure|Therapeutic Conventional Surgery|Undergo surgical hysterectomy
16379599|NCT00064012|Drug|bortezomib|
16379600|NCT00064012|Drug|docetaxel|
16379609|NCT00063986|Procedure|Minimally invasive esophagectomy (MIE)|Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
16379610|NCT00063973|Drug|cilengitide|Given IV
16379611|NCT00063973|Other|laboratory biomarker analysis|Correlative studies
16379612|NCT00063960|Drug|floxuridine|
16379619|NCT00063934|Drug|doxorubicin hydrochloride|Given IV
16379620|NCT00063934|Drug|docetaxel|Given IV
16379621|NCT00063934|Biological|filgrastim|Given SC
16379622|NCT00063934|Biological|pegfilgrastim|Given SC
16379623|NCT00063934|Procedure|therapeutic conventional surgery|Undergo surgical resection
16379624|NCT00063934|Other|pharmacological study|Optional correlative studies
16379625|NCT00063934|Other|laboratory biomarker analysis|Optional correlative studies
16379626|NCT00063895|Drug|erlotinib hydrochloride|Given PO
16379627|NCT00063895|Other|pharmacological study|Correlative studies
16379628|NCT00063895|Other|pharmacogenomic studies|Correlative studies
16379629|NCT00063895|Other|laboratory biomarker analysis|Correlative studies
16379630|NCT00063882|Radiation|Brachytherapy (100/110)|100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.
16379631|NCT00063882|Radiation|Brachytherapy (125/145)|125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
16379632|NCT00063882|Radiation|External Beam Radiation Therapy|Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.
16379633|NCT00063869|Drug|Etanercept|
16379634|NCT00023907|Drug|paclitaxel|
16379635|NCT00005940|Radiation|iodine I 131 monoclonal antibody BC8|Given IV
16379636|NCT00005940|Drug|busulfan|Given PO
16379637|NCT00005940|Drug|cyclophosphamide|Given IV
16379638|NCT00005940|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic PBSC or bone marrow transplant
16379639|NCT00005940|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSC or bone marrow transplant
16379640|NCT00005940|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC or bone marrow transplant
16379641|NCT00005940|Drug|cyclosporine|Given IV or PO
16379642|NCT00005940|Drug|methotrexate|Given IV
16379643|NCT00005940|Other|laboratory biomarker analysis|Correlative studies
16379644|NCT00003211|Biological|filgrastim|
16379645|NCT00003211|Drug|amifostine trihydrate|
16379646|NCT00003211|Drug|cisplatin|
16379647|NCT00003211|Drug|cyclophosphamide|
16379648|NCT00003211|Drug|vincristine sulfate|
16379649|NCT00003211|Procedure|peripheral blood stem cell transplantation|
16379650|NCT00003211|Radiation|radiation therapy|
16379651|NCT00002878|Drug|dexamethasone|
16379652|NCT00002878|Drug|doxorubicin hydrochloride|
16379653|NCT00002878|Drug|valspodar|
16379654|NCT00002878|Drug|vincristine sulfate|
16379655|NCT00063856|Biological|Wetvax (APSV)|
16379656|NCT00063843|Biological|Recombinant Protective Antigen, Anthrax Vaccine Adsorbed|
16379657|NCT00063830|Drug|Alicaforsen|
16379658|NCT00063817|Drug|Conditioning Regimen|Cyclophosphamide 60 mg per kilogram (kg) of body weight per day intravenously (IV) on days -5 and -4 with respect to transplantation; humanized anti-CD2 monoclonal antibody (MEDI-507) 0.6 mg per kg on days -1, 0, and 1 (after test dose of 0.1 mg per kg on day -2); and cyclosporine A 5 mg per kg IV and thymic irradiation (700 cGy) on day -1. Hemodialysis was performed before and 14 hours after each dose of cyclophosphamide.Kidney transplantation was followed by IV infusion of donor bone marrow. Oral cyclosporine A was administered postoperatively, 8 to 12 mg per kg per day, with target trough blood levels of 250 to 350 ng per milliliter; the dose was tapered and discontinued over a period of several months. Protocol amendment that applied to participant 4 and 5: rituximab, 375 mg per square meter of body-surface area days -7 and -2; and prednisone, 2 mg per kg per day starting on the day of transplantation with tapering over the next 10 days.
16379659|NCT00063804|Drug|Ritonavir|
16379660|NCT00063804|Drug|AMD070|
16379661|NCT00063791|Drug|Bortezomib|
16379662|NCT00063778|Biological|AVX101|Alphavirus replicon particle vaccine expressing HIV Gag antigen
16379663|NCT00063778|Other|placebo|phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
16379664|NCT00063752|Drug|PI-0824|
16379665|NCT00045357|Biological|therapeutic autologous lymphocytes|
16379666|NCT00042900|Drug|pyroxamide|
16379667|NCT00040820|Drug|oxaliplatin|
16379668|NCT00039169|Drug|ortataxel|
16379669|NCT00036660|Drug|SarCNU|
16379670|NCT00033384|Drug|CI-1040|
16379671|NCT00002752|Radiation|iodine I 131 monoclonal antibody 81C6|
16379672|NCT00002582|Drug|CMF regimen|
16379673|NCT00002582|Drug|cyclophosphamide|
16379674|NCT00002582|Drug|doxorubicin hydrochloride|
16379675|NCT00002582|Drug|fluorouracil|
16379676|NCT00002582|Drug|goserelin acetate|
16379677|NCT00002582|Drug|leuprolide acetate|
16379678|NCT00002582|Drug|methotrexate|
16379679|NCT00002582|Drug|tamoxifen citrate|
16379680|NCT00002582|Procedure|oophorectomy|
16379681|NCT00002582|Radiation|radiation therapy|
16379682|NCT00063765|Drug|Ciliary Neurotrophic Factor Implant NT-501|
16379683|NCT00063713|Drug|VELCADE TM (bortezomib) for Injection|
16379684|NCT00063700|Procedure|reducing exposure to marketing pressures|
16379685|NCT00063687|Drug|Oxypurinol|
16379686|NCT00063674|Behavioral|Nutrition Education|
16379687|NCT00063674|Behavioral|After-school dance class|
16379688|NCT00063648|Biological|EBV-specific autologous CTL|
16379689|NCT00063635|Drug|Metformin|500 mg, twice daily
16379690|NCT00063635|Dietary Supplement|Vitamin E|400 IU, twice daily
16379691|NCT00063635|Drug|Matching placebo|Twice daily
16379692|NCT00063622|Drug|Pioglitazone|30 mg daily
16379693|NCT00063622|Dietary Supplement|Vitamin E|800 IU daily
16379694|NCT00063622|Drug|Matching placebo|Daily
16379695|NCT00063609|Drug|zoledronic acid|
16379696|NCT00063596|Drug|Vitamin A supplementation|
16379697|NCT00063583|Drug|Pirfenidone|Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
16379698|NCT00063570|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 14 days, until disease progression
16379699|NCT00063570|Drug|Gemcitabine|1500 mg/m2, intravenous (IV), every 14 days, until disease progression
16379700|NCT00063570|Drug|Gemcitabine|1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
16379701|NCT00063570|Drug|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days, until disease progression
16379702|NCT00063323|Drug|Bupropion|
16379703|NCT00033319|Dietary Supplement|folic acid|
16379704|NCT00033319|Drug|acetylsalicylic acid|
16379705|NCT00031954|Drug|carboplatin|
16379706|NCT00031954|Drug|gemcitabine hydrochloride|
16379707|NCT00031954|Drug|paclitaxel|
16379708|NCT00031889|Drug|Exemestane|Exemestane
16379709|NCT00031889|Drug|Exemestane+bicalutamide|Exemestane as in arm I and oral bicalutamide once daily
16379710|NCT00031668|Radiation|radiation therapy|
16379711|NCT00028938|Biological|epoetin alfa|
16379712|NCT00028938|Drug|carboplatin|
16379713|NCT00028938|Drug|paclitaxel|
16379714|NCT00028938|Radiation|radiation therapy|
16379715|NCT00063479|Drug|Zoledronic Acid|
16379716|NCT00063453|Dietary Supplement|Vitamin E|vitamin E (400 IU/day all rac-α-tocopheryl acetate)
16379717|NCT00063453|Dietary Supplement|Selenium|selenium (200 μg/d L-selenomethionine)
16379718|NCT00063453|Dietary Supplement|Vitamin E placebo|placebo
16379719|NCT00063453|Dietary Supplement|Selenium placebo|placebo
16379720|NCT00028925|Biological|filgrastim|
16379721|NCT00028925|Drug|carboplatin|
16379722|NCT00028925|Drug|topotecan hydrochloride|
16379723|NCT00028925|Radiation|WBRT|
16379724|NCT00028613|Radiation|iodine I 131 monoclonal antibody Lym-1|
16379725|NCT00063427|Drug|MAC-321|
16379726|NCT00063414|Drug|Alicaforsen|
16379727|NCT00063401|Biological|Cetuximab:|400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
16379728|NCT00063401|Drug|Paclitaxel|175 mg/m2 Day 1, six 21-day cycles
16379729|NCT00063401|Drug|Carboplatin|AUC = 6 Day1, six 21-day cycles
16379730|NCT00063388|Biological|Cetuximab|Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
16379731|NCT00063375|Behavioral|Computer Based Cognitive Behavioral Therapy|
16379732|NCT00063362|Drug|Lithium|Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent /L (mEq/L).
16379733|NCT00063362|Drug|Lamotrigine|Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.
16379734|NCT00063362|Drug|Divalproex|Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.
16379735|NCT00063362|Drug|Placebo|Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.
16379736|NCT00063336|Behavioral|Cognitive Remediation|A computerized cognitive rehabilitation treatment with day-program activities
16379737|NCT00063336|Behavioral|Computer-skills training|A computerized cognitive rehabilitation treatment with day-program activities
16379738|NCT00030446|Drug|carboplatin|
16379739|NCT00030446|Drug|erlotinib hydrochloride|
16379740|NCT00028483|Drug|cBR96-doxorubicin immunoconjugate|
16379741|NCT00028483|Drug|docetaxel|
16379742|NCT00006968|Biological|filgrastim|
16379743|NCT00006968|Drug|cyclosporine|
16379744|NCT00006968|Drug|pentostatin|
16379745|NCT00006968|Procedure|allogeneic bone marrow transplantation|
16379746|NCT00006968|Procedure|peripheral blood stem cell transplantation|
16379747|NCT00003352|Drug|cyclophosphamide|600 mg/m2, IV, every 3 weeks
16379748|NCT00003352|Drug|Taxotere|60 mg/m2, IV, every 3 weeks
16379749|NCT00003352|Drug|Adriamycin|60 mg/m2, IV, every 3 weeks
16379750|NCT00063310|Drug|Leuprolide acetate|
16379751|NCT00063297|Drug|R209130|
16379752|NCT00040729|Genetic|mutation analysis|
16379753|NCT00063284|Device|Magstim Rapid Magnetic Stimulator|
16379754|NCT00063258|Drug|Tarceva (OSI-774)|150 mg/day, starting day 1 and stopping night prior to surgery.
16379755|NCT00063258|Drug|Paclitaxel|Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.
16379756|NCT00063258|Drug|Carboplatin|Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
16379757|NCT00063219|Drug|MAC-321|
16379758|NCT00063206|Drug|DVS-233 SR|
16379759|NCT00063193|Drug|minocycline|
16379760|NCT00063193|Drug|creatine|
16379761|NCT00063154|Drug|Pertuzumab|Pertuzumab was supplied as a single-use liquid formulation.
16379762|NCT00063141|Drug|cetuximab|Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
16379763|NCT00063141|Drug|Irinotecan|Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
16379764|NCT00063141|Drug|Irinotecan|Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
16379974|NCT00062179|Drug|carboplatin|Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
16379765|NCT00063128|Drug|insulin|"Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals.
~Inject into abdomen only."
16379766|NCT00063128|Drug|human insulin inhalation powder (HIIP)|"Administer HIIP within 15 minutes before meals.
~Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin.
~Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin"
16379767|NCT00030797|Drug|Irinotecan 70 mg/m2|Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
16379768|NCT00030797|Drug|Irinotecan 240 mg/m2|Irinotecan i.v. 240 mg/m2 day 1 and day 22
16379769|NCT00026520|Biological|recombinant interferon alfa|
16379770|NCT00026520|Drug|thalidomide|
16379771|NCT00026364|Drug|fluorouracil|
16379772|NCT00026364|Drug|gefitinib|
16379773|NCT00026364|Drug|irinotecan hydrochloride|
16379774|NCT00026364|Drug|leucovorin calcium|
16379775|NCT00026351|Biological|rituximab|
16379776|NCT00026351|Drug|pentostatin|
16379777|NCT00025571|Drug|HPPH|
16379778|NCT00006013|Drug|semaxanib|
16379779|NCT00004037|Drug|docetaxel|
16379780|NCT00003054|Drug|paclitaxel|
16379781|NCT00063232|Drug|Metformin|After complete medical evaluation and liver biopsy, patients who qualified for therapy were started on metformin in an initial dose of 500 mg once daily. After 2 weeks, the dose was increased to 500 mg twice daily and after 4 weeks to the full dose of 1000 mg twice daily. Subsequent dose reductions were carried out based on tolerance, with particular attention to gastrointestinal upset and abdominal bloating. Patients were seen in the out-patient clinic, had a brief medical history and examination and routine blood tests at 2 and 4 weeks after enrolment and every 4 weeks thereafter. The oral and intravenous glucose tolerance tests were repeated after 40 and 44 weeks respectively and liver biopsy and imaging tests at 48 weeks. Metformin was discontinued after 48 weeks in patients without diabetes on the pre-treatment evaluation.
16379782|NCT00063102|Drug|ABT-751|
16379783|NCT00063089|Drug|S. aureus Immune Globulin Intravenous (Human) 5%|
16379784|NCT00063076|Drug|Targretin Gel 1%|Alopecia lesions on one-half of the head including facial hair treated, and other half on head serves as control (untreated). Starting dose once every day till Week 3 then escalate to twice a day.
16379785|NCT00063050|Behavioral|Physical activity and nutrition intervention|
16379786|NCT00063037|Behavioral|Behavioral modification - nutrition education|
16379787|NCT00063024|Behavioral|Increased calcium intake|
16379788|NCT00063024|Behavioral|Weight-bearing physical activity|
16379789|NCT00063011|Behavioral|Calcium rich diet|
16379790|NCT00063011|Behavioral|Weight bearing exercise|
16379791|NCT00025545|Drug|cyclophosphamide|
16379792|NCT00025545|Drug|methotrexate|
16379793|NCT00025545|Procedure|peripheral blood stem cell transplantation|
16379794|NCT00025545|Radiation|radiation therapy|
16379795|NCT00024323|Drug|cisplatin|
16379796|NCT00024323|Drug|triapine|
16379797|NCT00024310|Dietary Supplement|folic acid|
16379798|NCT00024310|Drug|lometrexol|
16379799|NCT00024310|Drug|paclitaxel|
16379800|NCT00024141|Drug|fluorouracil|
16379801|NCT00024141|Drug|irinotecan hydrochloride|
16379802|NCT00023933|Drug|iodine I 131 monoclonal antibody CC49-deltaCH2|Given IV
16379803|NCT00062985|Behavioral|Mail-based weight loss intervention|
16379804|NCT00062985|Behavioral|Phone-based weight loss intervention|
16379805|NCT00062972|Drug|donepezil|
16379806|NCT00062972|Drug|glucose|
16379807|NCT00062959|Behavioral|Going Places: School program to prevent problem behavior|
16379808|NCT00062907|Biological|Recombinant DNA- pVAX/L523S|
16379809|NCT00062907|Biological|Recombinant adenovirus- Ad/L523S|
16379810|NCT00062894|Drug|Iodine I 131 Tositumomab|
16379811|NCT00062946|Drug|(18F)fallypride|
16379812|NCT00062933|Procedure|Laparotomy|
16379813|NCT00062881|Drug|Intrathecal Mafosfamide|
16379814|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379815|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379816|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379817|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379818|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379819|NCT00062868|Biological|LMP2 CTLs (ALSCER - Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
~Dose Level Two
~Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2
~Dose Level Three
~Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2"
16379820|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion - Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2"
16379821|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2"
16379822|NCT00062868|Biological|LMP1/2 CTLs (ALCI - Expansion Group C)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One
~Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2"
16379823|NCT00062855|Procedure|Skin Biopsy|
16379824|NCT00062855|Genetic|Gene Modified Neuroblastoma Cells|"The first two injections will be given at week 1 and week 2 (i.e., separated by one week). Patients will then have a two-week rest and the remaining two injections will be given (again separated by one week) at week 4 and week 5.
~A complete evaluation for evidence of toxicity and response will be performed at week 8 (after a 3 week rest).
~At the 8 week (month 2) evaluation, in the absence of progressive disease requiring therapy without excessive toxicity and if more transduced cells are available, the patient will have the option to receive four additional SC injections each separated by 1 month at the higher of the two dosage levels they originally received."
16379825|NCT00062842|Drug|Irinotecan|
16379826|NCT00062829|Behavioral|Teen Driving: Program for parents|A behavioral intervention targeting driving risks unique to young drivers, including completing a behavioral contract, was administered to the intervention group. The control group received safety information appropriate for new drivers.
16379827|NCT00062816|Drug|ISIS 14803, peginterferon alfa, ribavirin|
16379828|NCT00002643|Biological|filgrastim|
16379829|NCT00002643|Drug|amifostine trihydrate|
16379830|NCT00002643|Drug|cyclophosphamide|
16379831|NCT00002643|Drug|doxorubicin hydrochloride|
16379832|NCT00002643|Drug|etoposide|
16379833|NCT00002643|Drug|ifosfamide|
16379834|NCT00002643|Drug|topotecan hydrochloride|
16379835|NCT00002643|Drug|vincristine sulfate|
16379836|NCT00002643|Procedure|conventional surgery|
16379837|NCT00002643|Radiation|low-LET cobalt-60 gamma ray therapy|
16379838|NCT00002643|Radiation|low-LET electron therapy|
16379839|NCT00002643|Radiation|low-LET photon therapy|
16379840|NCT00062803|Drug|SR34006|
16379841|NCT00062803|Drug|(LMW)heparin|
16379842|NCT00062803|Drug|Warfarin VKA|
16379843|NCT00062803|Drug|Acenocoumarol VKA|
16379844|NCT00062790|Drug|Dutasteride|
16379845|NCT00027612|Drug|carmustine|IV
16379846|NCT00027612|Drug|irinotecan hydrochloride|IV
16379847|NCT00027612|Radiation|radiation therapy|
16379848|NCT00025376|Drug|PS-341|
16379849|NCT00025376|Procedure|Tumor Biopsy|
16379850|NCT00023868|Drug|FOLFIRI regimen|
16379851|NCT00023868|Drug|cisplatin|
16379852|NCT00023868|Drug|doxorubicin hydrochloride|
16379853|NCT00023868|Drug|fluorouracil|
16379854|NCT00023868|Drug|irinotecan hydrochloride|
16379855|NCT00023868|Drug|leucovorin calcium|
16379856|NCT00023868|Drug|mitomycin C|
16379857|NCT00022594|Drug|liposomal lurtotecan|
16379858|NCT00022529|Drug|BMS-214662|Given IV
16379859|NCT00022529|Biological|trastuzumab|Given IV
16379860|NCT00022529|Other|pharmacological study|Correlative studies
16379861|NCT00062764|Drug|Actos (Pioglitazone)|Pts receive drug in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum ALT levels do not fall to normal by the 1 year pt; if pts have a biochemical response, drug is continued for 3 years,
16379862|NCT00062751|Drug|Letrozole / Temsirolimus (CCI-779)|Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
16379863|NCT00062751|Drug|Letrozole / Temsirolimus (CCI-779)|Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
16379864|NCT00062751|Drug|Letrozole|Letrozole 2.5 mg daily
16379865|NCT00062738|Drug|paroxetine|Paroxetine CR 12.5 - 25 mg q hs
16379866|NCT00062738|Drug|Nortriptyline|nortriptyline 25 - 75 mg q hs
16379867|NCT00062738|Other|placebo|matching placebo
16379868|NCT00062699|Drug|Zemplar (paricalcitol injection)|
16379869|NCT00062699|Drug|Calcijex|
16379870|NCT00062712|Drug|Allogeneic Bone Marrow, Anti-Thymocyte Globulin (Sangstat) & Sirolimus (Wyeth-Ay|
16379871|NCT00062686|Drug|GW572016|
16379872|NCT00062673|Drug|Duloxetine|
16379873|NCT00062673|Drug|Placebo|
16379874|NCT00062660|Drug|Tipranavir|Tipranavir 250 mg soft elastic capsules
16379875|NCT00062647|Drug|Telavancin|Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
16379876|NCT00062647|Drug|Vancomycin, nafcillin, oxacillin, or cloxacillin|Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
16379877|NCT00062634|Behavioral|Female condom skills training|
16379878|NCT00062621|Procedure|Combined bone marrow and kidney transplant|
16379879|NCT00062608|Behavioral|Written self-disclosure|
16379880|NCT00062595|Drug|phylloquinone (K1)|
16379881|NCT00062595|Drug|menatetranone (MK4)|
16379882|NCT00062569|Behavioral|Bathing Support Intervention (BSI)|Bathing Support Intervention - Review of caregiver current practices and perceptions and care recipient behavioral symptoms associated with bathing with pattern analysis based on observation; skill building for bathing and communication techniques; coaching for implementation
16379883|NCT00062569|Behavioral|Caregiver reminiscence with coaching|"BSI plus Reminiscence - BSI as above plus caregiver interview to ascertain pleasant long-term memories (e.g. stories, pictures, music) developed into a crib sheet for caregiver use conversationally prior to and during the bath"
16379884|NCT00062556|Drug|Niacin Extended Release and Lovastatin Tablets|
16379885|NCT00062543|Procedure|Hepatic artery infusion of CD34+ cells|Donor's cells infused directly into liver through a groin catheter (hepatic artery).
16379886|NCT00062543|Device|Cobe Spectra|Mononuclear cells (MNC) collected by continuous-flow centrifugation using a blood cell separator (Cobe Spectra).
16379887|NCT00062530|Biological|SCBaL/M9|Oral recombinant Salmonella typhi HIV-1 gp120 vaccine
16379888|NCT00062504|Drug|Talampanel|10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks
16379889|NCT00062491|Drug|Karenitecin (BNP1350)|Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.
16379890|NCT00062478|Drug|Karenitecin (BNP1350)|Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.
16379891|NCT00022009|Drug|gemcitabine hydrochloride|
16379892|NCT00018954|Drug|asparaginase|
16379893|NCT00018954|Drug|cyclophosphamide|
16379894|NCT00018954|Drug|cytarabine|
16379895|NCT00018954|Drug|daunorubicin hydrochloride|
16379896|NCT00018954|Drug|doxorubicin hydrochloride|
16379897|NCT00018954|Drug|etoposide|
16379898|NCT00018954|Drug|ifosfamide|
16379899|NCT00018954|Drug|mercaptopurine|
16379900|NCT00018954|Drug|methotrexate|
16379901|NCT00018954|Drug|prednisone|
16379902|NCT00018954|Drug|vincristine sulfate|
16379903|NCT00018954|Procedure|conventional surgery|
16379904|NCT00018954|Radiation|radiation therapy|
16379905|NCT00017446|Drug|CP4071|
16379906|NCT00017394|Biological|bevacizumab|Given IV
16379907|NCT00017394|Drug|vinorelbine tartrate|Given IV
16379908|NCT00017394|Other|laboratory biomarker analysis|Correlative studies
16379909|NCT00017316|Drug|semaxanib|
16379910|NCT00017316|Drug|thalidomide|
16379911|NCT00062582|Drug|Roflumilast|
16379912|NCT00016107|Drug|estramustine phosphate sodium|Given orally
16379913|NCT00016107|Drug|docetaxel|Given IV
16379914|NCT00016107|Biological|bevacizumab|Given IV
16379915|NCT00016107|Other|laboratory biomarker analysis|Correlative studies
16379916|NCT00014664|Biological|apolizumab|
16379917|NCT00014534|Biological|filgrastim|6 mg sub Q
16379918|NCT00014534|Drug|cisplatin|60 mg/sq m IV
16379919|NCT00014534|Drug|doxorubicin hydrochloride|50 mg/ sq m IV
16379920|NCT00014534|Drug|gemcitabine hydrochloride|1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm
16379921|NCT00014170|Drug|gefitinib|Given orally
16379922|NCT00014170|Other|pharmacological study|Correlative studies
16379923|NCT00014170|Other|laboratory biomarker analysis|Correlative studies
16379924|NCT00014170|Other|questionnaire administration|Ancillary studies
16379925|NCT00014170|Procedure|quality-of-life assessment|Ancillary studies
16379926|NCT00012155|Biological|NV1020|
16379927|NCT00062465|Drug|TwHF|
16379928|NCT00062439|Drug|cisplatin|During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
16379929|NCT00062439|Drug|docetaxel|During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
16379930|NCT00062439|Drug|etoposide|During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.
16379931|NCT00062439|Procedure|conventional surgery|If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.
16379932|NCT00062439|Radiation|radiation therapy|Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.
16379933|NCT00062426|Biological|bevacizumab|
16379934|NCT00062426|Drug|capecitabine|
16379935|NCT00062426|Drug|fluorouracil|
16379936|NCT00062426|Drug|leucovorin calcium|
16379937|NCT00062426|Drug|oxaliplatin|
16379938|NCT00062400|Procedure|psychosocial assessment and care|
16379939|NCT00062387|Drug|perifosine|
16379940|NCT00062374|Drug|Cisplatin|Given IV
16379941|NCT00062374|Procedure|Computed Tomography|Undergo FDG and FLT PET/CT
16379942|NCT00062374|Radiation|Fludeoxyglucose F-18|Undergo FDG-PET/CT
16379943|NCT00062374|Other|Fluorothymidine F-18|Undergo FLT-PET/CT
16379944|NCT00062374|Drug|Irinotecan Hydrochloride|Given IV
16379945|NCT00062374|Procedure|Positron Emission Tomography|Undergo FDG and FLT PET/CT
16379946|NCT00062374|Procedure|Therapeutic Conventional Surgery|Undergo radical subtotal or total gastrectomy with lymph node dissection
16379947|NCT00062348|Drug|boronophenylalanine-fructose complex|
16379948|NCT00062348|Drug|sodium borocaptate|
16379949|NCT00062348|Procedure|conventional surgery|
16379950|NCT00062335|Radiation|radiation therapy|
16379951|NCT00062322|Drug|cisplatin|
16379952|NCT00062322|Drug|irinotecan hydrochloride|
16379953|NCT00062322|Procedure|conventional surgery|
16379954|NCT00062322|Procedure|neoadjuvant therapy|
16379955|NCT00062322|Radiation|radiation therapy|
16379956|NCT00062309|Radiation|radiation therapy|
16379957|NCT00062296|Biological|rituximab|
16379958|NCT00062296|Drug|epirubicin hydrochloride|
16379959|NCT00062283|Drug|L-alanosine|
16379960|NCT00062270|Drug|cisplatin|
16379961|NCT00062270|Drug|docetaxel|
16379962|NCT00062270|Drug|gefitinib|
16379963|NCT00062270|Drug|gemcitabine hydrochloride|
16379964|NCT00062270|Procedure|conventional surgery|
16379965|NCT00062270|Procedure|neoadjuvant therapy|
16379966|NCT00062270|Radiation|radiation therapy|
16379967|NCT00062257|Drug|irofulven|
16379968|NCT00062244|Biological|oblimersen sodium|Given IV
16379969|NCT00062231|Drug|amoxicillin-clavulanate potassium|
16379970|NCT00062231|Drug|ciprofloxacin|
16379971|NCT00062231|Drug|moxifloxacin hydrochloride|
16379972|NCT00062231|Procedure|management of therapy complications|
16379973|NCT00062205|Drug|imatinib mesylate|
16380178|NCT00061256|Drug|Calcium carbonate|
16379975|NCT00062179|Drug|celecoxib|Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
16379976|NCT00062179|Drug|paclitaxel|Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
16379977|NCT00062179|Other|Placebo|placebo 3-7 days before first dose of chemotherapy
16379978|NCT00062140|Drug|cyclophosphamide|
16379979|NCT00062140|Procedure|allogeneic bone marrow transplantation|
16379980|NCT00062140|Procedure|peripheral blood stem cell transplantation|
16379981|NCT00062140|Radiation|radiation therapy|
16379982|NCT00062127|Drug|irinotecan hydrochloride|Given IV
16379983|NCT00062127|Drug|thalidomide|Given orally
16379984|NCT00062127|Other|pharmacological study|Correlative studies
16379985|NCT00062114|Biological|rituximab|
16379986|NCT00062114|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16379987|NCT00062101|Drug|erlotinib hydrochloride|Given orally (PO)
16379988|NCT00062101|Drug|celecoxib|Given PO
16379989|NCT00062101|Other|laboratory biomarker analysis|Correlative studies
16379990|NCT00062075|Drug|romidepsin|Given IV
16379991|NCT00062062|Drug|carboplatin|
16379992|NCT00062062|Drug|gefitinib|
16379993|NCT00062062|Drug|paclitaxel|
16379994|NCT00062049|Biological|recombinant interleukin-7|
16379995|NCT00062036|Biological|aldesleukin|
16379996|NCT00062036|Biological|filgrastim|
16379997|NCT00062036|Biological|incomplete Freund's adjuvant|
16379998|NCT00062036|Biological|interleukin-2 gene|
16379999|NCT00062036|Biological|therapeutic tumor infiltrating lymphocytes|
16380000|NCT00062036|Drug|cyclophosphamide|
16380001|NCT00062036|Drug|fludarabine phosphate|
16380002|NCT00062023|Drug|Acetylsalicylic acid (Aspirin)|Patients receive oral aspirin once daily for 12 months.
16380003|NCT00062023|Drug|Sulindac|Patients receive oral sulindac twice daily for 12 months.
16380004|NCT00062023|Drug|Ursodiol|Patients receive oral ursodiol three times daily for 12 months.
16380005|NCT00062023|Other|Sulindac Placebo|Oral sulindac placebo twice daily.
16380006|NCT00062010|Biological|interferon alpha|Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
16380007|NCT00062010|Drug|13-cis-retinoic acid|13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
16380008|NCT00062010|Drug|paclitaxel|paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
16380009|NCT00061997|Dietary Supplement|inositol|
16380010|NCT00061984|Biological|pegfilgrastim|
16380011|NCT00061984|Drug|doxorubicin hydrochloride|
16380012|NCT00061984|Drug|ifosfamide|
16380013|NCT00061984|Procedure|multimodality therapy|
16380014|NCT00061958|Drug|arsenic trioxide|Given IV
16380015|NCT00061945|Drug|allopurinol|Given PO
16380016|NCT00061945|Drug|cyclophosphamide|Given IV
16380017|NCT00061945|Drug|daunorubicin hydrochloride|Given IV
16380018|NCT00061945|Drug|vincristine sulfate|Given IV
16380019|NCT00061945|Drug|dexamethasone|Given PO and as eye drops
16380020|NCT00061945|Drug|asparaginase|Given SC
16380021|NCT00061945|Biological|filgrastim|Given SC
16380022|NCT00061945|Drug|imatinib mesylate|Given PO
16380023|NCT00061945|Drug|methotrexate|Given IT, IV, and PO
16380024|NCT00061945|Drug|cytarabine|Given IV
16380025|NCT00061945|Drug|trimethoprim-sulfamethoxazole|Given PO
16380026|NCT00061945|Drug|mercaptopurine|Given PO
16380027|NCT00061945|Drug|leucovorin calcium|Given IV and PO
16380028|NCT00061945|Biological|alemtuzumab|Given SC
16380029|NCT00061945|Drug|acyclovir|Given PO
16380030|NCT00061945|Other|laboratory biomarker analysis|Correlative studies
16380031|NCT00061945|Other|pharmacological study|Correlative studies
16380032|NCT00061932|Drug|bortezomib|Given IV
16380033|NCT00061932|Drug|irinotecan|Given IV
16380034|NCT00061919|Drug|Carboplatin, etoposide & thalidomide|Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
16380035|NCT00061919|Drug|Carboplatin, etoposide & placebo|Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
16380036|NCT00061906|Drug|celecoxib|Treatment will be administered on an outpatient basis. Oral celecoxib will be given at the dose of 400 mg BID for total of 12 months. Patients will be advised to take this medication with food to improve absorption.
16380037|NCT00061893|Drug|celecoxib|Given orally, Celecoxib 250 mg/m2 PO BID (500mg/m2/day) from Day 1 of Cycle 1 through Day 21 of Cycle 14. The dose should be rounded off to the nearest 100 mg. If PK studies are being done, Celecoxib should be given 24 hours prior to the other drugs for Cycle 1 only. [Celecoxib may be interrupted for up to 7 days around the time of surgical procedures.] .
16380038|NCT00061893|Drug|cyclophosphamide|Given IV, 1200 mg/m2 IV infusion over 1 hour with MESNA uroprotection, on Day 1. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
16380039|NCT00061893|Drug|doxorubicin hydrochloride|Given IV, Doxorubicin 75 mg/ m2 /course continuous IV infusion over 48 hours, beginning Day 1. Note: The total doxorubicin dose per cycle is 75 mg/ m2, which will be given as 37.5 mg/m2/day x 2 days. Doxorubicin may be given as a continuous infusion or brief infusion.
16380040|NCT00061893|Drug|etoposide|Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
16380179|NCT00061256|Drug|Vitamin D|
16380041|NCT00061893|Drug|ifosfamide|Given IV,Ifosfamide 1800 mg/m2 /day IV infusion over 1 hour, Days 1-5 of each cycle. (9,000 mg/m2 max total dose per cycle). Prehydrate for 6 hours, 1,000 ml/m2 total volume (165 ml/m2/hour for 6 hours). For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
16380042|NCT00061893|Drug|vinblastine sulfate|Given IV, Vinblastine 1 mg/m2/d IV push three times per week beginning Day 1 of Cycle 1 and continuing through Day 21 of Cycle 14. In weeks during which vincristine is given, hold one dose of vinblastine and administer only 2 doses of vinblastine during that week. If vinblastine is due the same day as vincristine, hold that dose of vinblastine. [Vinblastine may be interrupted for up to 7 days around the time of surgical procedures.]
16380043|NCT00061893|Drug|vincristine sulfate|Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children < 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
16380044|NCT00061893|Procedure|conventional surgery|Patients who respond to induction chemotherapy undergo surgery on week 13. Patients who have inadequate margins after surgery undergo radiotherapy beginning on week 15. (see Detailed Description for frequency of administration and groups evaluated)
16380045|NCT00061893|Radiation|radiation therapy|Patients with unresectable lesions undergo radiotherapy 5 days a week for approximately 6 weeks beginning on week 13. (see Detailed Description for frequency of administration and groups evaluated)
16380046|NCT00061893|Drug|MESNA|The total daily MESNA dose is equal to at least 60% of the daily cyclophosphamide or ifosfamide dose, or by continuous infusion of the 60% dose. MESNA continuous infusion should be started at the same time as the cyclophosphamide/ifosfamide and be completed no sooner than 8 hours after the end of the cyclophosphamide or ifosfamide infusion. The oral dose of MESNA is 2x the IV dose. Patients able to tolerate oral MESNA may receive the final dose by mouth at 40% of the oxazaphosphorine (cyclophosphamide or ifosfamide) dose. The dose should be given two hours earlier than the IV dose would be given. Additionally, if the patient vomits within two hours after the oral dose, the dose should be repeated or IV MESNA given.
16380047|NCT00061893|Drug|Filgrastim|G-CSF (Filgrastim) 5 micrograms/kg/day subcutaneously beginning 24 to 48 hours after the last dose of chemotherapy, and continuing until the absolute neutrophil count is 2,000/µL or greater after nadir.
16380048|NCT00061880|Drug|forodesine hydrochloride|
16380049|NCT00061867|Drug|pegylated liposomal doxorubicin hydrochloride|
16380050|NCT00061867|Procedure|hyperthermia treatment|
16380051|NCT00061854|Drug|soblidotin|
16380052|NCT00061841|Behavioral|exercise|
16380053|NCT00061815|Biological|cetuximab|400 mg/m2 IV
16380054|NCT00061815|Drug|oxaliplatin|85 mg/m2 IV
16380055|NCT00061815|Drug|leucovorin|200 mg/m2 IV
16380056|NCT00061815|Drug|5-fluorouracil|400 mg/m2 IV
16380057|NCT00061815|Drug|5-fluorouracil|600 mg/m2 IV
16380058|NCT00061815|Biological|cetuximab|250 mg/m2 IV
16380059|NCT00033462|Drug|erlotinib hydrochloride|Given orally
16380060|NCT00033462|Other|laboratory biomarker analysis|Correlative studies
16380061|NCT00010231|Dietary Supplement|calcitriol|
16380062|NCT00010231|Drug|dexamethasone|
16380063|NCT00009932|Drug|cisplatin|
16380064|NCT00009932|Drug|fenretinide|
16380065|NCT00009932|Drug|paclitaxel|
16380066|NCT00009802|Dietary Supplement|calcitriol|
16380067|NCT00009802|Drug|paclitaxel|
16380068|NCT00061802|Drug|risperidone, quetiapine|
16380069|NCT00009789|Radiation|accelerated conformational radiotherapy|
16380070|NCT00008424|Drug|irinotecan hydrochloride|
16380071|NCT00008398|Biological|sargramostim|
16380072|NCT00008398|Procedure|quality-of-life assessment|
16380073|NCT00008398|Radiation|radiation therapy|
16380074|NCT00008203|Biological|aldesleukin|
16380075|NCT00008203|Biological|recombinant interferon gamma|
16380076|NCT00008203|Drug|carboplatin|
16380077|NCT00008203|Drug|cyclophosphamide|
16380078|NCT00008203|Drug|cyclosporine|
16380079|NCT00008203|Drug|thiotepa|
16380080|NCT00008203|Procedure|autologous bone marrow transplantation|
16380081|NCT00008203|Procedure|peripheral blood stem cell transplantation|
16380082|NCT00008112|Drug|cisplatin|
16380083|NCT00008112|Procedure|hyperthermia treatment|
16380084|NCT00008112|Radiation|brachytherapy|
16380085|NCT00008112|Radiation|radiation therapy|
16380086|NCT00061789|Drug|SPECT Imaging of Nicotinic Acetylcholine Receptors in Brain|
16380087|NCT00061776|Drug|Capsaicin Dermal Patch|
16380088|NCT00061763|Drug|Deferasirox|
16380089|NCT00061750|Drug|ICL670|
16380090|NCT00061750|Drug|deferoxamine|
16380091|NCT00061711|Drug|Hormone Replacement Therapy|
16380092|NCT00061711|Drug|Cimicifuga racemosa (Black Cohosh)|
16380093|NCT00061711|Drug|Multibotanical phytoestrogen formula|
16380094|NCT00061698|Behavioral|Cognitive Behavior Therapy Child Only|Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
16380095|NCT00061698|Behavioral|CBT plus Parent Training|Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.
16380096|NCT00061672|Drug|ABT-510 - Thrombospondin-1 Mimetic|
16380097|NCT00061659|Drug|ABT-510 - Thrombospondin-1 mimetic|
16380098|NCT00061646|Drug|ABT-510/Thrombospondin-1 mimetic|
16380099|NCT00061646|Drug|Carboplatin/Taxol|
16380100|NCT00051714|Behavioral|Family-Based Preventive Intervention|
16380101|NCT00061633|Drug|Telavancin|Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
16380267|NCT00003203|Radiation|radiation therapy|1.8 Gy/fx x 20fx=36Gy Craniospinal XRT*
16380102|NCT00061633|Drug|Vancomycin or antistaphylococcal penicillin|Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
16380103|NCT00061620|Drug|Tezacitabine (FMdC)|7.5 mg/m2 bolus infusion daily x 5
16380104|NCT00059462|Drug|Interleukin-2 SA|HAART and Bay 50-4798
16380105|NCT00059462|Drug|HAART|HAART alone
16380106|NCT00008021|Biological|filgrastim|
16380107|NCT00008021|Biological|monoclonal antibody Lym-1|
16380108|NCT00008021|Drug|cyclosporine|
16380109|NCT00008021|Drug|paclitaxel|
16380110|NCT00008021|Procedure|peripheral blood stem cell transplantation|
16380111|NCT00008021|Radiation|indium In 111 monoclonal antibody Lym-1|
16380112|NCT00008021|Radiation|yttrium Y 90 monoclonal antibody Lym-1|
16380113|NCT00006864|Biological|aldesleukin|
16380114|NCT00006484|Drug|carboplatin|
16380115|NCT00006484|Drug|paclitaxel|
16380116|NCT00006484|Drug|tirapazamine|
16380117|NCT00061594|Drug|rhuFab V2 (ranibizumab)|
16380118|NCT00061542|Drug|BETOPTIC S (betaxolol HCl)|betaxolol HC)
16380119|NCT00061542|Drug|Timolol Gel-forming Solution (TGFS)|timolol maleate 0.25% and 0.5%
16380120|NCT00061529|Drug|Brimonidine Tartrate Ophthalmic Solution|
16380121|NCT00061516|Drug|BETAXON (levobetaxolol HCl)|levobetaxolol suspension, 0.5%
16380122|NCT00061516|Drug|AZOPT (brinzolamide)|brinzolamide suspension, 1%
16380123|NCT00061503|Drug|Travoprost|
16380124|NCT00006464|Drug|7-hydroxystaurosporine|
16380125|NCT00006464|Drug|cisplatin|
16380126|NCT00006457|Drug|oltipraz|
16380127|NCT00006383|Drug|liposomal vincristine sulfate|
16380128|NCT00006377|Drug|carboplatin|
16380129|NCT00006377|Drug|doxorubicin hydrochloride|
16380130|NCT00006377|Drug|paclitaxel|
16380131|NCT00006361|Drug|semaxanib|
16380132|NCT00061581|Device|Isolex 300i Stem Cell Selection|
16380133|NCT00061568|Procedure|Peripheral blood hematopoietic progenitor cell (PBPC) transplant|Peripheral blood hematopoietic progenitor cell (PBPC) transplant
16380134|NCT00061568|Drug|Alemtuzumab|Alemtuzumab
16380135|NCT00061568|Procedure|Peripheral blood hematopoietic progenitor cell Apherisis|Donor-Peripheral blood hematopoietic progenitor cell (PBPC) apheresis
16380136|NCT00061568|Drug|Sirolimus|Sirolimus
16380137|NCT00061490|Behavioral|Behavioral weight control and lifestyle exercise|16 weekly educational meetings vs. waitlist control
16380138|NCT00061477|Drug|Pemetrexed|
16380139|NCT00061477|Drug|Gemcitabine|
16380140|NCT00061464|Drug|pemetrexed|
16380141|NCT00061464|Drug|gemcitabine|
16380142|NCT00061451|Drug|Pemetrexed|
16380143|NCT00061451|Drug|Gemcitabine|
16380144|NCT00006349|Dietary Supplement|vitamin E|
16380145|NCT00006349|Drug|donepezil hydrochloride|
16380146|NCT00006349|Other|placebo|
16380147|NCT00006341|Other|Implant|A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
16380148|NCT00061438|Drug|meropenem|
16380149|NCT00061425|Drug|radiolabeled epratuzumab|
16380150|NCT00061412|Behavioral|Comprehensive program to improve reading and writing skills|
16380151|NCT00061386|Behavioral|Nutrition and physical activity program|
16380152|NCT00061321|Drug|Nevirapine and mulitvitamins|Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
16380153|NCT00061308|Drug|Topotecan|
16380154|NCT00061308|Drug|Gemcitabine|
16380155|NCT00061295|Procedure|Body weight support treadmill training|
16380156|NCT00045149|Biological|aldesleukin|
16380157|NCT00045149|Biological|therapeutic tumor infiltrating lymphocytes|
16380158|NCT00019734|Biological|aldesleukin|
16380159|NCT00019734|Biological|fowlpox virus vaccine vector|
16380160|NCT00019734|Biological|vaccinia-tyrosinase vaccine|
16380161|NCT00061373|Drug|Aspirin|A single 81 mg aspirin tablet orally (or rectal suppository equivalent dose) given as soon as possible after start of standard iv tPA and consent.
16380162|NCT00061373|Drug|tinzaparin sodium|A single weight-based dose of 80 anti-Xa International Units/kilogram (IU/kg)administered by subcutaneous (SQ) injection.
16380163|NCT00061373|Drug|eptifibatide|Eptifibatide administered iv according to dose escalation group. The five dosing groups for eptifibatide are 0, 45 µg/kg bolus, 90 µg/kg bolus, 90 µg/kg bolus plus 0.25 µg/kg/min infusion for 24 hours, and 90 µg/kg bolus plus 0.5 µg/kg/min infusion for 24 hours.
16380164|NCT00061360|Drug|ATG+Rapamune+cyclosporine|ATG+Rapamune+cyclosporine
16380165|NCT00061360|Drug|ATG+cyclosporine|ATG+cyclosporine
16380166|NCT00061347|Procedure|Fiducial marker placement|Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
16380167|NCT00061282|Drug|Clotrimazole|One retention enema, administered nightly
16380168|NCT00041353|Other|cytology specimen collection procedure|
16380169|NCT00041353|Procedure|comparison of screening methods|
16380170|NCT00041353|Procedure|study of high risk factors|
16380171|NCT00019175|Biological|aldesleukin|
16380172|NCT00019175|Biological|fowlpox virus vaccine vector|
16380173|NCT00019175|Biological|gp100 antigen|
16380174|NCT00002786|Biological|aldesleukin|
16380175|NCT00002786|Biological|therapeutic tumor infiltrating lymphocytes|
16380176|NCT00061269|Procedure|Videoscopic-Assisted Retroperitoneal Debridement (VARD)|
16380177|NCT00061256|Drug|Alendronate|
16380180|NCT00061243|Biological|HIV-1 DNA vaccine with protein vaccine boost|Three doses of DNA vaccination will be administered at weeks 0, 4, and 12, and 2 doses of protein vaccination at weeks 20 and 28
16380181|NCT00061230|Behavioral|biofeedback-monitored relaxation training|
16380182|NCT00061217|Device|Unrectified prosthetic socket|
16380183|NCT00061217|Device|Rectified prosthetic socket|
16380184|NCT00061178|Drug|rhuMAb VEGF (Bevacizumab)|
16380185|NCT00061165|Behavioral|School + family changes promoting healthy eating + activity|
16380186|NCT00019084|Biological|aldesleukin|
16380187|NCT00019084|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
16380188|NCT00019084|Biological|ras peptide cancer vaccine|
16380189|NCT00019084|Biological|sargramostim|
16380190|NCT00019084|Biological|therapeutic autologous lymphocytes|
16380191|NCT00019084|Biological|therapeutic tumor infiltrating lymphocytes|
16380192|NCT00015821|Drug|thalidomide|Given PO
16380193|NCT00015821|Other|laboratory biomarker analysis|Correlative studies
16380194|NCT00004868|Drug|semaxanib|
16380195|NCT00003408|Biological|aldesleukin|
16380196|NCT00003408|Biological|recombinant interferon alfa|
16380197|NCT00003408|Biological|sargramostim|
16380198|NCT00061152|Drug|Capsaicin Dermal Patch|
16380199|NCT00061139|Behavioral|Pediatric Constraint-Induced Movement therapy|
16380200|NCT00061139|Behavioral|Conventional pediatric motor rehabilitation therapy|
16380201|NCT00061126|Drug|ABX-EGF|
16380202|NCT00061113|Drug|Fluoxetine + outpatient cognitive behavioral therapy|single fixed morning dose 20 mg X 15 weeks
16380203|NCT00061113|Drug|fluoxetine|20mg, QD x 16 weeks
16380204|NCT00061113|Drug|placebo + CBT|single fixed morning dose X 16 weeks
16380205|NCT00061100|Behavioral|Behavior Therapy-RISE|manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
16380206|NCT00061100|Behavioral|Standard prevention Education|standard psychosocial Education for HIV/hepatitis prevention
16380207|NCT00061087|Drug|Methylphenidate|Methylphenidate 80mg/day
16380208|NCT00061087|Drug|Bupropion|Bupropion 400mg/day
16380209|NCT00061087|Other|Placebo|Placebo
16380210|NCT00061074|Drug|Nicotrol|
16380211|NCT00061061|Behavioral|Behavior Therapy|
16380212|NCT00061035|Biological|Transgenic Lymphocyte Immunization Vaccine (TLI)|
16380213|NCT00006243|Biological|tyrosinase peptide|Given SC
16380214|NCT00006243|Biological|MART-1:27-35 peptide vaccine|Given SC
16380215|NCT00006243|Biological|gp100 antigen|Given SC
16380216|NCT00006243|Biological|incomplete Freund's adjuvant|Given SC
16380217|NCT00006243|Biological|sargramostim|Given SC
16380218|NCT00006243|Other|laboratory biomarker analysis|Correlative studies
16380219|NCT00006242|Drug|BMS-214662|Given IV
16380220|NCT00006242|Other|laboratory biomarker analysis|Correlative studies
16380221|NCT00006242|Other|pharmacological study|Correlative studies
16380222|NCT00006095|Drug|irinotecan hydrochloride|
16380223|NCT00006095|Drug|vincristine sulfate|
16380224|NCT00006086|Drug|BMS-188797|
16380225|NCT00006086|Drug|carboplatin|
16380226|NCT00006082|Drug|rubitecan|
16380227|NCT00061048|Biological|Alemtuzumab|Infusion of Campath-1H 3 mg on day # 1, 10 mg on day #2, and 30 mg day # 3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
16380228|NCT00061022|Drug|NXY-059|
16380229|NCT00006046|Biological|monoclonal antibody hu3S193|
16380230|NCT00005999|Drug|arsenic trioxide|
16380231|NCT00005977|Biological|filgrastim|Given IV
16380232|NCT00005977|Drug|cyclophosphamide|Given IV
16380233|NCT00005977|Drug|cytarabine|Given IV
16380234|NCT00005977|Drug|dexamethasone|Given IV
16380235|NCT00005977|Drug|doxorubicin hydrochloride|Given IV
16380236|NCT00005977|Drug|etoposide|Given IV
16380237|NCT00005977|Drug|ifosfamide|Given IV
16380238|NCT00005977|Drug|leucovorin calcium|Given IV
16380239|NCT00005977|Drug|methotrexate|Given IV
16380240|NCT00005977|Drug|vincristine sulfate|Given IV
16380241|NCT00005971|Drug|alvocidib|
16380242|NCT00005956|Biological|HER-2/neu intracellular domain protein|
16380243|NCT00005956|Biological|therapeutic autologous dendritic cells|
16380244|NCT00005868|Drug|cisplatin|
16380245|NCT00005868|Drug|docetaxel|
16380246|NCT00060996|Drug|Remodulin® (treprostinil sodium) Injection|
16380247|NCT00005813|Biological|bispecific antibody MDX447|
16380248|NCT00005813|Biological|lymphokine-activated killer cells|
16380249|NCT00005813|Procedure|conventional surgery|
16380250|NCT00060983|Procedure|Body weight supported locomotor training|
16380251|NCT00060983|Procedure|Functional electrical stimulation|
16380252|NCT00060970|Procedure|Physical Therapy|
16380253|NCT00060957|Drug|Botulinum toxin type A|
16380254|NCT00060944|Drug|Yondelis|1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
16380255|NCT00060944|Drug|Yondelis|0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
16380256|NCT00060944|Drug|Dexamethasone|Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
16380257|NCT00060944|Drug|Dexamethasone|Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
16380258|NCT00005861|Drug|pegylated liposomal doxorubicin hydrochloride|
16380259|NCT00005588|Radiation|radiation therapy|
16380260|NCT00005587|Radiation|radiation therapy|
16380261|NCT00003203|Biological|filgrastim|Given IV
16380262|NCT00003203|Drug|carboplatin|Given IV
16380263|NCT00003203|Drug|cisplatin|Given IV
16380264|NCT00003203|Drug|cyclophosphamide|Given IV
16380265|NCT00003203|Drug|vincristine sulfate|Given IV
16380266|NCT00003203|Procedure|adjuvant therapy|
16380272|NCT00060905|Drug|Divalproex Sodium (Depakote ER)|
16380273|NCT00060892|Genetic|HGF plasmid|Intramuscular injections into index leg on Days 0, 14, and 28
16380274|NCT00005086|Drug|cisplatin|
16380275|NCT00005086|Drug|docetaxel|
16380276|NCT00005086|Drug|gemcitabine hydrochloride|
16380277|NCT00005086|Drug|methotrexate|
16380278|NCT00005078|Drug|carboplatin|
16380279|NCT00005078|Drug|paclitaxel|
16380280|NCT00005078|Drug|tirapazamine|
16380281|NCT00060866|Drug|Propranolol|
16380282|NCT00060840|Drug|Nitric Oxide|40 ppm of Nitric Oxide continuously administered for 48 hours
16380283|NCT00060840|Drug|Nitrogen|Nitrogen (N2) administered at 40 ppm for 48 hours
16380284|NCT00060827|Device|Head Impact Recording Technology (HIRT)|
16380285|NCT00060814|Other|Combined intervention|300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
16380286|NCT00060801|Drug|BIIL 283 BS (Amelubent)|
16380287|NCT00004931|Drug|leucovorin calcium|Given IV
16380288|NCT00004931|Drug|fluorouracil|Given IV
16380289|NCT00004931|Drug|oxaliplatin|Given IV
16380290|NCT00004931|Other|laboratory biomarker analysis|Correlative studies
16380291|NCT00004928|Dietary Supplement|calcitriol|
16380292|NCT00004928|Drug|zoledronic acid|
16380293|NCT00004925|Biological|trastuzumab|
16380294|NCT00004925|Drug|pegylated liposomal doxorubicin hydrochloride|
16380295|NCT00004916|Drug|ifosfamide|
16380296|NCT00004916|Drug|paclitaxel|
16380297|NCT00004916|Drug|teniposide|
16380298|NCT00004916|Procedure|peripheral blood stem cell transplantation|
16380299|NCT00004911|Procedure|bowel obstruction management|
16380300|NCT00004911|Procedure|quality-of-life assessment|
16380301|NCT00060762|Behavioral|Interpersonal Therapy|20 sessions of interpersonal therapy were provided over a 6-month period
16380302|NCT00060762|Behavioral|Behavioral Weight Loss Treatment|20 sessions of behavioral weight loss treatment were provided over a 6-month period
16380303|NCT00060762|Behavioral|Guided Self Help|10 sessions of guided self help were provided over a 6-month period
16380304|NCT00060710|Drug|CP-461|
16380305|NCT00060749|Drug|Docosahexaenoic Acid (DHA) Dietary Supplement|
16380306|NCT00060697|Behavioral|Adolescent sexual activity education for mothers|
16380307|NCT00060684|Drug|Pixantrone (BBR 2778)|
16380308|NCT00060684|Drug|fludarabine|
16380309|NCT00060684|Drug|dexamethasone|
16380310|NCT00060684|Drug|rituximab|
16380311|NCT00060671|Drug|rituximab|
16380312|NCT00060671|Drug|Pixantrone (BBR 2778)|
16380313|NCT00060645|Drug|ridaforolimus|There are sequential dosage cohorts ranging from 3 mg - 225 mg per dose. AP23573 is given intravenously over 30 minutes, administered once daily for 5 days every 2 weeks.
16380314|NCT00060632|Drug|ridaforolimus|"Administered intravenously once weekly for 4 weeks (1 cycle).
~In the absence of disease progression or unacceptable toxicity, patients could continue to receive additional cycles."
16380315|NCT00060619|Behavioral|thermal biofeedback|
16380316|NCT00060619|Behavioral|relaxation training|
16380317|NCT00060619|Behavioral|cognitive coping skills|
16380318|NCT00060619|Behavioral|parent education|
16380319|NCT00060606|Procedure|Prenatal Myelomeningocele Repair Surgery|Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation.
16380320|NCT00060606|Procedure|Postnatal Myelomeningocele Repair Surgery|Standard postnatal surgical closure of the spina bifida defect
16380321|NCT00060567|Drug|E7070 + irinotecan combination|Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
16380322|NCT00060567|Drug|Irinotecan + E7070 combination|Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
16380323|NCT00060567|Drug|Irinotecan + E7070 combination|Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
16380324|NCT00004910|Procedure|bowel obstruction management|
16380325|NCT00004910|Procedure|quality-of-life assessment|
16380326|NCT00004895|Drug|octreotide acetate|
16380327|NCT00004255|Biological|anti-thymocyte globulin|
16380328|NCT00004255|Biological|filgrastim|
16380329|NCT00004255|Drug|cyclophosphamide|
16380330|NCT00004255|Drug|fludarabine phosphate|
16380331|NCT00004255|Drug|methylprednisolone|
16380332|NCT00004255|Drug|tacrolimus|
16380333|NCT00004255|Procedure|allogeneic bone marrow transplantation|
16380334|NCT00004255|Procedure|in vitro-treated bone marrow transplantation|
16380335|NCT00004255|Radiation|radiation therapy|
16380336|NCT00004232|Biological|filgrastim|
16380337|NCT00004232|Drug|cyclosporine|
16380338|NCT00004232|Drug|methylprednisolone|
16380339|NCT00004232|Drug|prednisone|
16380340|NCT00004232|Procedure|allogeneic bone marrow transplantation|
16380341|NCT00004232|Procedure|peripheral blood stem cell transplantation|
16380342|NCT00004180|Drug|rosiglitazone maleate|
16380343|NCT00060580|Procedure|Raman scattering spectroscopy|
16380344|NCT00060554|Drug|fondaparinux sodium|
16380345|NCT00060554|Drug|heparin|
16380346|NCT00060554|Procedure|percutaneous coronary intervention (PCI)|
16380347|NCT00060515|Drug|RG2133 (2',3',5'-tri-O-acetyluridine)|
16380348|NCT00060502|Drug|Infliximab; Gemcitabine|
16380349|NCT00060489|Drug|SEROQUEL (quetiapine fumarate) Tablets|
16380350|NCT00004094|Drug|carboplatin|
16380351|NCT00004094|Drug|fluorouracil|
16380352|NCT00004094|Drug|hydroxyurea|
16380353|NCT00004094|Drug|paclitaxel|
16380354|NCT00004094|Procedure|conventional surgery|
16380355|NCT00004094|Radiation|radiation therapy|
16380356|NCT00004068|Drug|irinotecan hydrochloride|
16380357|NCT00004068|Drug|temozolomide|
16380358|NCT00004068|Procedure|conventional surgery|
16380359|NCT00004068|Radiation|radiation therapy|
16380360|NCT00004059|Drug|7-hydroxystaurosporine|
16380363|NCT00004052|Biological|bcr-abl peptide vaccine|
16380364|NCT00004008|Drug|bryostatin 1|
16380365|NCT00060528|Drug|Recombinant Fowlpox-GM-CSF|
16380366|NCT00060528|Drug|Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM)|
16380367|NCT00060528|Drug|Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM)|
16380368|NCT00060528|Drug|Recombinant Human GM-CSF|
16380369|NCT00060476|Drug|rofecoxib|
16380370|NCT00060476|Drug|Comparator: placebo (unspecified)|
16380371|NCT00060463|Behavioral|Increased access to emergency contraceptive pills|
16380372|NCT00060450|Drug|nitric oxide for inhalation|Either 10 or 20 ppm of inhaled nitric oxide for 24 hour post transplant
16380373|NCT00060450|Drug|Placebo|Placebo gas will be given at 10 or 20 ppm for 24 hours post transplant
16380374|NCT00060437|Drug|perifosine|
16380375|NCT00060424|Drug|Cyclosporine|Given PO
16380376|NCT00060424|Drug|Fludarabine Phosphate|Given IV
16380377|NCT00060424|Procedure|Hematopoietic Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
16380378|NCT00060424|Other|Laboratory Biomarker Analysis|Correlative studies
16380379|NCT00060424|Drug|Mycophenolate Mofetil|Given PO
16380380|NCT00060424|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
16380381|NCT00060424|Radiation|Total-Body Irradiation|Undergo TBI
16380382|NCT00060411|Drug|erlotinib hydrochloride|Given IV
16380383|NCT00060411|Drug|fluorouracil|Given IV
16380384|NCT00060411|Drug|leucovorin calcium|Given IV
16380385|NCT00060411|Drug|oxaliplatin|Given IV
16380386|NCT00060411|Biological|bevacizumab|Given IV
16380387|NCT00060398|Biological|epoetin alfa|
16380388|NCT00060398|Drug|dexamethasone|
16380389|NCT00060385|Drug|CHOP regimen|
16380390|NCT00060385|Drug|EPOCH regimen|
16380391|NCT00060385|Drug|cyclophosphamide|
16380392|NCT00060385|Drug|doxorubicin hydrochloride|
16380393|NCT00060385|Drug|etoposide|
16380394|NCT00060385|Drug|prednisone|
16380395|NCT00060385|Drug|vincristine sulfate|
16380396|NCT00060385|Radiation|radiation therapy|
16380397|NCT00060372|Drug|ipilimumab|Given IV
16380398|NCT00060372|Drug|therapeutic allogeneic lymphocytes|Given IV
16380399|NCT00060359|Drug|Carboplatin|Given IV
16380400|NCT00060359|Drug|Paclitaxel Poliglumex|Given IV
16380401|NCT00060359|Other|Pharmacological Study|Correlative studies
16380402|NCT00060346|Biological|rituximab|Rituximab is given intravenously. The initial rate is 50 mg/hr for the 1st hour. If no toxicity, the rate may be escalated in 50 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr. If the patient experiences fever and rigors, the antibody infusion is discontinued. The severity of the side effects should be evaluated. If the symptoms improve, the infusion is continued initially at half the previous rate. Following the antibody infusion, the intravenous line should be maintained for medications as needed. If there are no complications after one hour of observation, the intravenous line may be discontinued.
16380403|NCT00060346|Drug|cyclophosphamide|"Cyclophosphamide will be given at a dosage of 750 mg/m² intravenously on day 1 of each cycle (1 cycle =21 days) for 6 cycles. Dose is based on surface area calculated based on actual body weight.
~The drug should be administered as a rapid IV infusion over 5 to 30 minutes."
16380404|NCT00060346|Drug|Doxorubicin|"Doxorubicin will be given intravenously at a dosage of 50 mg/m² on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
~Doxorubicin should be administered as a continuous infusion into tubing of a freely flowing intravenous line for 5 -15 minutes. Avoid extravasation."
16380405|NCT00060346|Drug|Prednisone|Prednisone will be administered at 100 mg/m² orally, days 1-5 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
16380406|NCT00060346|Drug|Vincristine|"Vincristine will be administered 1.4 mg/m² intravenously (Maximum dose = 2.0 mg) on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
~Given as IV push over 1 minute, using extravasation precautions."
16380407|NCT00060333|Radiation|radiation therapy|
16380408|NCT00060320|Dietary Supplement|black cohosh|
16380409|NCT00060320|Other|placebo|
16380410|NCT00060307|Drug|erlotinib hydrochloride|Given orally
16380411|NCT00060307|Other|laboratory biomarker analysis|Correlative studies
16380412|NCT00060294|Biological|rituximab|
16380413|NCT00060294|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16380414|NCT00060268|Drug|HPPH|iv
16380415|NCT00060255|Drug|busulfan|iv
16380416|NCT00060255|Drug|carboplatin|iv
16380417|NCT00060255|Drug|carmustine|iv
16380418|NCT00060255|Drug|cyclophosphamide|iv
16380419|NCT00060255|Drug|etoposide|iv
16380420|NCT00060255|Drug|melphalan|oral
16380421|NCT00060255|Drug|thiotepa|iv
16380422|NCT00060255|Procedure|autologous bone marrow transplantation|iv
16380423|NCT00060255|Procedure|bone marrow ablation with stem cell support|iv
16380424|NCT00060255|Procedure|peripheral blood stem cell transplantation|iv
16380425|NCT00060255|Radiation|radiation therapy|body x-ray
16380426|NCT00060242|Drug|fosbretabulin disodium|Combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.
16380427|NCT00060203|Drug|brostallicin|"Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity."
16380428|NCT00060151|Drug|pazopanib hydrochloride|
16380429|NCT00060138|Biological|monoclonal antibody CAL|
16380430|NCT00060138|Drug|zoledronic acid|
16380431|NCT00060125|Drug|tipifarnib|Given orally
16380432|NCT00060125|Other|laboratory biomarker analysis|Correlative studies
16380433|NCT00060112|Biological|oblimersen sodium|Given IV
16380434|NCT00060112|Drug|gemcitabine hydrochloride|Given IV
16380435|NCT00060112|Other|pharmacological study|Correlative studies
16380436|NCT00060112|Other|laboratory biomarker analysis|Correlative studies
16380437|NCT00060099|Biological|HspE7|
16380438|NCT00060086|Dietary Supplement|pomegranate juice|Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
16380439|NCT00060021|Procedure|acupuncture therapy|
16380440|NCT00060021|Procedure|management of therapy complications|
16380441|NCT00060021|Procedure|pain therapy|
16380442|NCT00060008|Radiation|fludeoxyglucose F 18|
16380443|NCT00060008|Radiation|gadopentetate dimeglumine|
16380444|NCT00059995|Biological|iratumumab|
16380445|NCT00059982|Drug|perifosine|
16380446|NCT00059943|Drug|docetaxel|
16380447|NCT00059930|Drug|FOLFOX regimen|
16380448|NCT00059930|Drug|dexamethasone|
16380449|NCT00059930|Drug|floxuridine|
16380450|NCT00059930|Drug|fluorouracil|
16380451|NCT00059930|Drug|leucovorin calcium|
16380452|NCT00059930|Drug|oxaliplatin|
16380453|NCT00059930|Procedure|adjuvant therapy|
16380454|NCT00059930|Procedure|conventional surgery|
16380455|NCT00059917|Drug|polyglutamate camptothecin|
16380456|NCT00059904|Biological|aldesleukin|
16380457|NCT00059904|Biological|rituximab|
16380458|NCT00059891|Procedure|conventional surgery|
16380459|NCT00059891|Procedure|management of therapy complications|
16380460|NCT00059878|Biological|recombinant interferon gamma|
16380461|NCT00059878|Drug|voriconazole|
16380462|NCT00059865|Drug|gemcitabine hydrochloride|
16380463|NCT00059865|Drug|pemetrexed disodium|
16380464|NCT00059852|Drug|erlotinib hydrochloride|
16380465|NCT00059852|Drug|gemcitabine hydrochloride|
16380466|NCT00059839|Drug|doxorubicin hydrochloride|Given IV
16380467|NCT00059839|Drug|mercaptopurine|Given by mouth
16380468|NCT00059839|Drug|methotrexate|Given IV and intrathecally
16380469|NCT00059839|Drug|prednisone|Given by mouth
16380470|NCT00059839|Drug|vinblastine sulfate|Given IV
16380471|NCT00059839|Drug|vincristine sulfate|Given IV
16380472|NCT00059826|Biological|interferon-alfa-2b|IV
16380473|NCT00059826|Drug|cisplatin|IV
16380474|NCT00059826|Drug|5-fluorouracil|IV
16380475|NCT00059826|Radiation|radiation therapy|
16380476|NCT00059813|Biological|recombinant interferon alfa|Given SC
16380477|NCT00059813|Biological|oblimersen sodium|Given IV
16380478|NCT00059813|Other|pharmacological study|Correlative studies
16380479|NCT00059800|Radiation|boron neutron capture therapy|
16380480|NCT00059787|Drug|paclitaxel|Given IV
16380481|NCT00059787|Drug|carboplatin|Given IV
16380482|NCT00059787|Drug|erlotinib|Given PO
16380483|NCT00059761|Drug|cisplatin|
16380484|NCT00059761|Drug|irinotecan hydrochloride|
16380485|NCT00059761|Radiation|radiation therapy|
16380486|NCT00059735|Drug|E7070|
16380487|NCT00043108|Drug|carboplatin|
16380488|NCT00043108|Drug|paclitaxel|
16380489|NCT00043108|Procedure|conventional surgery|
16380490|NCT00043108|Radiation|radiation therapy|
16380491|NCT00030667|Drug|imatinib mesylate|Given orally
16380492|NCT00030667|Other|laboratory biomarker analysis|Correlative studies
16380493|NCT00030667|Other|pharmacological study|Correlative studies
16380494|NCT00030524|Drug|gefitinib|
16380495|NCT00027599|Biological|bevacizumab|
16380496|NCT00027599|Biological|prostatic acid phosphatase-sargramostim fusion protein|
16380497|NCT00027599|Biological|sipuleucel-T|
16380498|NCT00027599|Biological|therapeutic autologous dendritic cells|
16380499|NCT00027599|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16380500|NCT00017134|Drug|fenretinide|
16380501|NCT00017134|Procedure|conventional surgery|
16380502|NCT00016315|Drug|carboplatin|
16380503|NCT00016315|Drug|gemcitabine hydrochloride|
16380504|NCT00016315|Drug|paclitaxel|
16380505|NCT00016315|Radiation|radiation therapy|
16380506|NCT00006225|Biological|filgrastim|
16380507|NCT00006225|Biological|recombinant flt3 ligand|
16380508|NCT00006225|Biological|recombinant human thrombopoietin|
16380509|NCT00006225|Biological|recombinant interleukin-3|
16380510|NCT00006225|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16380511|NCT00005793|Drug|Cytarabine|
16380512|NCT00005793|Drug|Daunorubicin|
16380513|NCT00005793|Drug|Etoposide|
16380514|NCT00005793|Drug|Topotecan|
16380515|NCT00005065|Drug|paclitaxel|Given IV
16380516|NCT00005065|Drug|carboplatin|Given IV
16380517|NCT00005065|Drug|motexafin gadolinium|Given IV
16380518|NCT00005065|Procedure|conventional surgery|Undergo complete surgical resection
16380519|NCT00005065|Radiation|radiation therapy|Undergo radiation therapy
16380520|NCT00004127|Drug|FOLFOX regimen|
16380521|NCT00004127|Drug|fluorouracil|
16380522|NCT00004127|Drug|leucovorin calcium|
16380523|NCT00004127|Drug|oxaliplatin|
16380524|NCT00004095|Drug|gemcitabine hydrochloride|
16380525|NCT00004095|Drug|irinotecan hydrochloride|
16380526|NCT00019435|Biological|LMB-9 immunotoxin|
16380527|NCT00002765|Biological|LMB-2 immunotoxin|
16380528|NCT00059722|Drug|ZD6474|
16380529|NCT00059722|Drug|Placebo|
16380530|NCT00059722|Drug|ZD1839|
16380531|NCT00059709|Procedure|Mediated Negotiation Training|
16380532|NCT00059696|Procedure|Constraint-Induced Movement Therapy|
16380705|NCT00002945|Biological|aldesleukin|IV
16380533|NCT00059683|Procedure|cervical cerclage|Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
16380534|NCT00018941|Biological|aldesleukin|
16380535|NCT00005837|Drug|oxaliplatin|
16380536|NCT00005818|Drug|irinotecan hydrochloride|Given IV
16380537|NCT00005818|Drug|semaxanib|Given IV
16380538|NCT00005818|Other|laboratory biomarker analysis|Correlative studies
16380539|NCT00005025|Biological|herpes simplex thymidine kinase|
16380540|NCT00005025|Drug|ganciclovir|
16380541|NCT00002971|Drug|O6-benzylguanine|
16380542|NCT00059670|Procedure|Shaker Exercise vs. Traditional Dysphagia Therapy Regime|
16380543|NCT00059657|Drug|Ecraprost in lipid emulsion|
16380544|NCT00059644|Drug|Ecraprost in lipid emulsion|
16380545|NCT00003933|Other|laboratory biomarker analysis|
16380546|NCT00003926|Drug|amifostine trihydrate|"Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1.
~Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined."
16380547|NCT00003926|Drug|busulfan|Patients receive oral busulfan every 6 hours on days -8 to -6.
16380548|NCT00003926|Drug|filgrastim|All patients receive filgrastim (G-CSF) IV for 1 week.
16380549|NCT00003926|Drug|melphalan|melphalan intravenous (IV) over 30 minutes on days -5 and -4
16380550|NCT00003926|Drug|thiotepa|thiotepa intravenous (IV) over 2 hours on days -3 and -2.
16380551|NCT00003926|Procedure|peripheral blood stem cell transplantation (PBSC)|PBSC are reinfused on day 0
16380552|NCT00003925|Drug|gemcitabine hydrochloride|
16380553|NCT00003925|Drug|leucovorin calcium|
16380554|NCT00003925|Drug|tegafur-uracil|
16380555|NCT00003802|Drug|pyrazoloacridine|
16380556|NCT00003797|Biological|trastuzumab|
16380557|NCT00003797|Drug|gemcitabine hydrochloride|
16380558|NCT00059631|Drug|Mitoxantrone (Novantrone)|Starting dose of 3 mg/m^2, four weekly intravenous injections (on Days 1, 8, 15 and 22) over eight 5 week cycles.
16380559|NCT00059631|Drug|Bortezomib (PS-341)|Starting Dose of 1.4 mg/m^2, four weekly intravenous injections (on Days 1, 8, 15, and 22) over eight 5 week cycles.
16380560|NCT00059618|Drug|PS-341 (Bortezomib)|Starting dose 0.8 mg/m^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.
16380561|NCT00059618|Drug|Carboplatin|AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.
16380562|NCT00059605|Genetic|DOTAP:Chol-fus1|Infusion of DOTAP:Chol-fus1 by vein once every 3 weeks.
16380563|NCT00059592|Drug|Valacyclovir|
16380564|NCT00003757|Biological|rituximab|
16380565|NCT00003649|Biological|Ad5CMV-p53 gene|
16380566|NCT00003627|Drug|cisplatin|
16380567|NCT00003627|Drug|fluorouracil|
16380568|NCT00003627|Radiation|radiation therapy|
16380569|NCT00003484|Drug|carmustine|
16380570|NCT00003484|Drug|irinotecan hydrochloride|
16380571|NCT00003484|Procedure|surgical procedure|
16380572|NCT00003484|Radiation|iodine I 131 monoclonal antibody 81C6|
16380573|NCT00003436|Drug|amsacrine|
16380574|NCT00003436|Drug|asparaginase|
16380575|NCT00003436|Drug|cytarabine|
16380576|NCT00003436|Drug|daunorubicin hydrochloride|
16380577|NCT00003436|Drug|etoposide|
16380578|NCT00003436|Drug|methotrexate|
16380579|NCT00003436|Drug|mitoxantrone hydrochloride|
16380580|NCT00003436|Drug|therapeutic hydrocortisone|
16380581|NCT00003436|Procedure|allogeneic bone marrow transplantation|
16380582|NCT00059553|Behavioral|Locomotor treadmill training with body weight support|
16380583|NCT00059527|Behavioral|Healthy Youth Places: a behavior change model|
16380584|NCT00059514|Behavioral|Modified Project Toward No Tobacco Use|
16380585|NCT00005836|Drug|oxaliplatin|
16380586|NCT00059475|Drug|Glycoprotein 100 (GP100): 209-217 (210M)|
16380587|NCT00059475|Drug|Interleukin-2 (IL-2)|720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours and continuing for up to 4 days (a maximum of 12 doses).
16380588|NCT00059475|Drug|Montanide ISA 51|
16380589|NCT00059475|Drug|Melanoma antigen recognized by T-cells (MART)-1: 27-35|
16380590|NCT00059475|Drug|27-35 (27L): melanoma antigen recognized by T-cells (MART)-1|
16380591|NCT00059475|Drug|melanoma antigen recognized by T-cells (MART)-1: 26-35(27L)|
16380592|NCT00059436|Behavioral|Mental effort in muscle strengthening|
16380593|NCT00003432|Biological|carcinoembryonic antigen RNA-pulsed DC cancer vaccine|Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses.
16380594|NCT00003346|Drug|acetaminophen|
16380595|NCT00003346|Drug|acetylcysteine|
16380596|NCT00003346|Drug|carmustine|
16380597|NCT00003341|Biological|epoetin alfa|
16380598|NCT00003341|Procedure|quality-of-life assessment|
16380599|NCT00003324|Procedure|conventional surgery|
16380600|NCT00003324|Radiation|radiation therapy|
16380601|NCT00003311|Biological|filgrastim|
16380602|NCT00003311|Drug|cyclophosphamide|
16380603|NCT00003311|Drug|cytarabine|
16380604|NCT00003311|Drug|dexamethasone|
16380605|NCT00003311|Drug|doxorubicin hydrochloride|
16380606|NCT00003311|Drug|methotrexate|
16380607|NCT00003311|Drug|vincristine sulfate|
16380608|NCT00059384|Behavioral|Concentration-controlled therapy|
16380609|NCT00059371|Procedure|male circumcision|
16380610|NCT00059358|Drug|Ribavirin plus interferon alfa-2b|Oral tablets taken daily
16380611|NCT00059358|Drug|Ribavirin|Oral tablet taken daily
16380612|NCT00059358|Drug|Peginterferon alfa-2b|Subcutaneous injection
16380613|NCT00059345|Procedure|Acupuncture|Electroacupuncture treatments provided two times per week for 6 weeks
16380614|NCT00059345|Procedure|Placebo acupuncture|Placebo acupuncture treatments provided 2 times per week for 6 weeks
16380615|NCT00059345|Other|Usual Care|Usual care for knee osteoarthritis
16380706|NCT00002945|Biological|filgrastim|IV
16380616|NCT00059332|Drug|Magnesium Sulfate|Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
16380617|NCT00059332|Drug|Normal Saline|Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
16380618|NCT00059319|Procedure|single aorta clamp with retrograde cardioplegia|
16380619|NCT00059319|Procedure|multiple aorta clamps with antegrade cardioplegia|
16380620|NCT00059306|Drug|aspirin|Participants receive aspirin + placebo, specifically: aspirin (325 mg) with placebo (an inactive substance). Participants will take 1 of each pill a day until the end of the study.
16380621|NCT00059306|Drug|clopidogrel|Participants will receive aspirin + clopidogrel, specifically: aspirin (325 mg) with clopidogrel (75 mg)-- Participants will take 1 of each pill a day until the end of the study.
16380622|NCT00059306|Other|Target of Blood Pressure|Participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 mmHg or below 130 mmHg; to do so, the scientists will use medications that are already in the market for blood pressure management.
16380623|NCT00059306|Other|placebo|an inactive substance
16380624|NCT00058981|Drug|DiaPep277|
16380625|NCT00059280|Biological|Myozyme|20 mg/kg qow or 40mg/kg qow
16380626|NCT00059267|Drug|HBIG, Epivir, Hepsera|
16380627|NCT00059254|Dietary Supplement|Oleic acid (OA)|OA-enriched (HI OA; fat, 40%; PA, 1.7%; OA, 31.4%)
16380628|NCT00059254|Dietary Supplement|Palmitic Acid (PA)|PA-enriched (HI PA; fat, 40% of energy; PA, 16.8%; OA, 16.4%)
16380629|NCT00059241|Behavioral|Parent-child communication education|
16380630|NCT00059241|Behavioral|Service learning|
16380631|NCT00059241|Behavioral|Classroom health curriculum|
16380632|NCT00059215|Drug|Prasugrel (CS-747)|Administered orally
16380633|NCT00059215|Drug|Clopidogrel|Administered orally
16380634|NCT00003290|Biological|gonadotrophin releasing hormone|
16380635|NCT00003290|Radiation|radiation therapy|
16380636|NCT00003262|Biological|bleomycin sulfate|
16380637|NCT00003262|Biological|filgrastim|
16380638|NCT00003262|Drug|Stanford V regimen|
16380639|NCT00003262|Drug|doxorubicin hydrochloride|
16380640|NCT00003262|Drug|epirubicin hydrochloride|
16380641|NCT00003262|Drug|etoposide|
16380642|NCT00003262|Drug|mechlorethamine hydrochloride|
16380643|NCT00003262|Drug|prednisone|
16380644|NCT00003262|Drug|vinblastine sulfate|
16380645|NCT00003262|Drug|vincristine sulfate|
16380646|NCT00003205|Drug|bryostatin 1|
16380647|NCT00003193|Drug|amifostine trihydrate|
16380648|NCT00003193|Drug|paclitaxel|
16380649|NCT00003193|Procedure|conventional surgery|
16380650|NCT00003193|Radiation|radiation therapy|
16380651|NCT00003173|Biological|filgrastim|
16380652|NCT00003173|Drug|thiotepa|
16380653|NCT00003173|Procedure|autologous bone marrow transplantation|
16380654|NCT00003173|Procedure|peripheral blood stem cell transplantation|
16380655|NCT00059228|Drug|17beta Estradiol|Alora 100 microgram per day by skin patch for 6 weeks.
16380656|NCT00059228|Drug|Placebos|Placebo skin patch for 6 weeks
16380657|NCT00059202|Drug|Ursodeoxycholic Acid|Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
16380658|NCT00059202|Drug|Placebo|Placebo for Urso
16380659|NCT00059189|Device|Magstim Rapid Magnetic Stimulator|
16380660|NCT00005839|Drug|capecitabine|
16380661|NCT00005839|Drug|oxaliplatin|
16380662|NCT00004220|Drug|gemcitabine hydrochloride|
16380663|NCT00004220|Drug|oxaliplatin|
16380664|NCT00004257|Drug|fluorouracil|
16380665|NCT00004257|Drug|oxaliplatin|
16380666|NCT00004257|Procedure|conventional surgery|
16380667|NCT00004257|Radiation|radiation therapy|
16380668|NCT00004243|Drug|docetaxel|
16380669|NCT00004243|Drug|oxaliplatin|
16380670|NCT00003597|Biological|recombinant human thrombopoietin|
16380671|NCT00003597|Drug|carboplatin|
16380672|NCT00003597|Drug|etoposide|
16380673|NCT00003597|Drug|ifosfamide|
16380674|NCT00003597|Biological|G-CSF|
16380675|NCT00003163|Biological|filgrastim|
16380676|NCT00003163|Biological|sargramostim|
16380677|NCT00003163|Drug|cyclophosphamide|
16380678|NCT00003163|Drug|melphalan|
16380679|NCT00003163|Procedure|autologous bone marrow transplantation|
16380680|NCT00003163|Procedure|peripheral blood stem cell transplantation|
16380681|NCT00003163|Radiation|radiation therapy|
16380682|NCT00003162|Procedure|pain therapy|
16380683|NCT00003162|Radiation|radiation therapy|
16380684|NCT00003129|Drug|valrubicin|
16380685|NCT00003124|Drug|flutamide|
16380686|NCT00003124|Drug|leuprolide acetate|
16380687|NCT00003124|Radiation|radiation therapy|
16380688|NCT00003064|Biological|filgrastim|
16380689|NCT00003064|Drug|carboplatin|
16380690|NCT00003064|Drug|etoposide phosphate|
16380691|NCT00003064|Drug|paclitaxel|
16380692|NCT00003064|Drug|thiotepa|
16380693|NCT00003064|Drug|topotecan hydrochloride|
16380694|NCT00003064|Procedure|peripheral blood stem cell transplantation|
16380695|NCT00002972|Drug|paclitaxel|
16380696|NCT00058994|Drug|anecortave acetate|
16380697|NCT00058968|Drug|Duloxetine hydrochloride|
16380698|NCT00058968|Drug|placebo|
16380699|NCT00058955|Drug|sodium oxybate, triazolam and pentobarbital|sodium oxybate, triazolam and pentobarbital
16380700|NCT00058942|Device|home drinking water treatment device|
16380701|NCT00058929|Drug|treprostinil sodium|
16380702|NCT00058903|Drug|sertraline|
16380703|NCT00058890|Drug|Gabapentin|Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.
16380707|NCT00002945|Drug|cyclophosphamide|IV
16380708|NCT00002945|Drug|cytarabine|IV
16380709|NCT00002945|Drug|etoposide|IV
16380710|NCT00002945|Drug|idarubicin|IV
16380711|NCT00002945|Drug|melphalan|IV
16380712|NCT00002945|Procedure|peripheral blood stem cell transplantation|IV
16380713|NCT00002945|Radiation|radiation therapy|delivered to the cancer cells
16380714|NCT00002934|Procedure|long-term screening|
16380715|NCT00002835|Biological|Bleomycin Sulfate (BLM)|
16380716|NCT00002835|Biological|Filgrastim (G-CSF)|Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.
16380717|NCT00002835|Biological|Recombinant Interferon Alfa|
16380718|NCT00002835|Drug|Carmustine|Arm 1, Course 3, IV over 1 hour on day -6.
16380719|NCT00002835|Drug|Cisplatin (CDDP)|
16380720|NCT00002835|Drug|Cyclophosphamide|
16380721|NCT00002835|Drug|Cytarabine (ARA-C)|Arm 1, Course 3, every 12 hours on days -5 to -2.
16380722|NCT00002835|Drug|Etoposide (VP-16)|Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.
16380723|NCT00002835|Drug|Idarubicin|
16380724|NCT00002835|Drug|Ifosfamide|During Course 1, IV continuously; Course 2, IV continuously on days 1-3.
16380725|NCT00002835|Drug|Leucovorin Calcium|
16380726|NCT00002835|Drug|Melphalan|
16380727|NCT00002835|Drug|Methotrexate|
16380728|NCT00002835|Drug|Methylprednisolone|
16380729|NCT00002835|Drug|mitoxantrone hydrochloride (DHAD)|Arm 1, Course 2, IV on day 1.
16380730|NCT00002835|Drug|Vincristine Sulfate|
16380731|NCT00002835|Procedure|Peripheral Blood Stem Cell Transplantation|Infusion of stem cells on Day 0.
16380732|NCT00002835|Radiation|Radiation Therapy|
16380733|NCT00002822|Drug|carboplatin|
16380734|NCT00002822|Drug|cisplatin|
16380735|NCT00002822|Drug|cyclophosphamide|
16380736|NCT00002822|Drug|doxorubicin hydrochloride|
16380737|NCT00002822|Drug|etoposide|
16380738|NCT00002822|Drug|ifosfamide|
16380739|NCT00002822|Drug|mesna|
16380740|NCT00002822|Drug|vincristine sulfate|
16380741|NCT00002822|Radiation|radiation therapy|
16380742|NCT00058864|Device|Energy absorbing and distributing trochanteric pad|
16380743|NCT00058851|Procedure|Manual lymph drainage|
16380744|NCT00058851|Procedure|Combined physiotherapy|
16380745|NCT00058851|Procedure|Compression bandaging|
16380746|NCT00058838|Drug|sumanirole|
16380747|NCT00058825|Biological|Campath 1H|Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
16380748|NCT00058825|Drug|Fludarabine|Day -5 to Day -2: Fludarabine 30 mg/m2.
16380749|NCT00058825|Procedure|Stem Cell Transplant|Day 0: Donor stem cells infused.
16380750|NCT00058825|Radiation|Total Body Irradiation (TBI)|Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
16380751|NCT00058825|Drug|FK506 (Tacrolimus) or Cyclosporine|Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.
16380752|NCT00058812|Biological|EBV specific T cells|One injection of 2x10^7 cells/m2 from Day 45 post transplant. If EBV DNA levels remain elevated above 1000 copies/ug or the patient has persistent disease they will be eligible to receive up to 5 additional injections of CTLs at the original dose at monthly intervals.
16380753|NCT00058799|Biological|Dose Level 1|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 2 x 10^5
16380754|NCT00058799|Biological|Dose Level 2|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 2 x 10^5
16380755|NCT00058799|Biological|Dose Level 3|Leukemic Blasts 2 x 10^7; IL-2 Fibroblasts 2 x 10^7; CD40L Fibroblasts 4.2 x 10^7
16380756|NCT00058786|Biological|Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells|Patients may be treated with a minimum of three up to six injections of their IL-2-secreting and CD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window, i.e. in the absence of concurrent cytotoxic therapy. Any patient whose disease regresses after the administration of 6 injections may be offered further injections (i.e. more than 6 injections) of tumor vaccine at the dose level previously administered, if enough vaccines are available. Patients will receive a fixed dose of IL-2 secreting B-CLL cells throughout the entire treatment protocol (see Section 5.8), determined by previous studies in acute leukemia and in neuroblastoma, in which this level of IL-2 production has been safe. The dose escalation of CD40L-expressing cells is designed to reach the IL2/CD40L ratio shown to be effective in our preclinical models of neuroblastoma and lymphoma.
16380757|NCT00058773|Drug|Infusion of EBV Specific Cytotoxic T-Lymphocytes|"EBV specific cytotoxic T-lymphocytes will be given by intravenous injection over 1-10 minutes.
~Each patient will receive two injections, 14 days apart."
16380758|NCT00058760|Behavioral|NIA intervention (after school health promotion didactic program)|
16380759|NCT00058747|Drug|Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.|
16380760|NCT00058734|Biological|Dendritic Cells Pulsed with HIV antigens|
16380761|NCT00058721|Drug|I-123-5-IA85380|
16380762|NCT00058682|Drug|Anidulafungin|
16380763|NCT00002777|Drug|exemestane|
16380764|NCT00002777|Drug|tamoxifen citrate|
16380765|NCT00002701|Drug|busulfan|
16380766|NCT00002701|Drug|cyclophosphamide|
16380767|NCT00002701|Drug|cytarabine|
16380768|NCT00002701|Drug|etoposide|
16380769|NCT00002701|Drug|idarubicin|
16380770|NCT00002701|Drug|mercaptopurine|
16380771|NCT00002701|Drug|methotrexate|
16380772|NCT00002701|Drug|mitoxantrone hydrochloride|
16380773|NCT00002701|Drug|thioguanine|
16380774|NCT00002701|Drug|tretinoin|
16380775|NCT00002701|Procedure|allogeneic bone marrow transplantation|
16380776|NCT00002701|Procedure|autologous bone marrow transplantation|
16380777|NCT00002701|Radiation|radiation therapy|
16380778|NCT00002695|Genetic|DNA stability analysis|
16380779|NCT00002695|Genetic|microsatellite instability analysis|
16380780|NCT00002695|Genetic|mutation analysis|
16380781|NCT00002695|Other|laboratory biomarker analysis|
16380782|NCT00002693|Biological|filgrastim|
16380783|NCT00002693|Drug|carboplatin|
16380784|NCT00002693|Drug|topotecan hydrochloride|
16380785|NCT00002669|Biological|aldesleukin|
16380786|NCT00002669|Biological|recombinant interferon alfa|
16380787|NCT00002669|Drug|cisplatin|
16380788|NCT00002669|Drug|dacarbazine|
16380789|NCT00058656|Procedure|Infusion of Activated & Expanded Autologous T Cells|
16380790|NCT00002658|Biological|filgrastim|
16380791|NCT00002658|Drug|amsacrine|
16380792|NCT00002658|Drug|cyclophosphamide|
16380793|NCT00002658|Drug|cytarabine|
16380794|NCT00002658|Drug|daunorubicin hydrochloride|
16380795|NCT00002658|Drug|etoposide|
16380796|NCT00002658|Drug|idarubicin|
16380797|NCT00002658|Drug|mitoxantrone hydrochloride|
16380798|NCT00002658|Drug|thioguanine|
16380799|NCT00002658|Drug|tretinoin|
16380800|NCT00002658|Procedure|allogeneic bone marrow transplantation|
16380801|NCT00002658|Procedure|autologous bone marrow transplantation|
16380802|NCT00002658|Procedure|peripheral blood stem cell transplantation|
16380803|NCT00002658|Radiation|radiation therapy|
16380804|NCT00002653|Drug|carmustine|
16380805|NCT00002653|Drug|cyclophosphamide|
16380806|NCT00002653|Drug|doxorubicin hydrochloride|
16380807|NCT00002653|Drug|melphalan|
16380808|NCT00002653|Drug|prednisone|
16380809|NCT00002653|Radiation|radiation therapy|
16380810|NCT00002575|Procedure|conventional surgery|
16380811|NCT00002575|Procedure|laparoscopic surgery|
16380812|NCT00002550|Drug|cisplatin|
16380813|NCT00002550|Drug|etoposide|
16380814|NCT00002550|Procedure|conventional surgery|
16380815|NCT00002550|Radiation|radiation therapy|
16380816|NCT00002539|Biological|filgrastim|
16380817|NCT00002539|Drug|cisplatin|
16380818|NCT00002539|Drug|doxorubicin hydrochloride|
16380819|NCT00002539|Procedure|conventional surgery|
16380820|NCT00058617|Biological|Injection of EBV Specific CTLs|"Each patient will receive two injections, 14 days apart, according to the following dosing schedules:
~Group One Day 0 2x10^7 cells/m2 Day 14 2x10^7 cells/m2
~Group Two Day 0 2x10^7 cells/m2 Day 14 1x10^8 cells/m2
~Group Three Day 0 1x10^8 cells/m2 Day 14 2x 10^8 cells/m2
~If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
16380821|NCT00058604|Biological|Intravenous injection of EBV specific CTLs|Each patient will receive injections of 2x10e7 , 5x10e7 , or 10e8 CTLs/m2 via IV injection. 6 weeks = 1 course
16380822|NCT00058591|Biological|Intravenous injection of EBV specific CTLS|"The dose levels for this study are as follows:
~Level Dose
~2 x 107 CTLs/m2
~5 x 107 CTLs/m2
~1 x 108 CTLs/m2
~If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals."
16380823|NCT00058578|Drug|Cyclophosphamide|
16380824|NCT00058578|Drug|Mesna|
16380825|NCT00058578|Drug|G-CSF|
16380826|NCT00058578|Procedure|Leukopheresis|
16380827|NCT00058578|Procedure|Total Body Irradiation|
16380828|NCT00058552|Drug|Pertuzumab (rhuMAb 2C4)|
16380829|NCT00058539|Drug|rhuMAb 2C4 (pertuzumab)|
16380830|NCT00058526|Biological|Immunotherapeutic SB719125 (Primary)|Intramuscular injection
16380831|NCT00058487|Drug|epirubicin hydrochloride|
16380832|NCT00058487|Drug|thalidomide|
16380833|NCT00058474|Drug|capecitabine|825 mg/m2 oral daily 5 days a week on days of planned RT
16380834|NCT00058474|Drug|fluorouracil|225 mg/m2 IV daily continuous infusion
16380835|NCT00058474|Drug|oxaliplatin|50 mg/m2 IV 5 days a week on days of planned RT
16380836|NCT00058474|Radiation|radiation therapy|Given 5 days a week for 5-6 weeks
16380837|NCT00058461|Drug|ifosfamide|Given IV
16380838|NCT00058461|Drug|etoposide|Given IV
16380839|NCT00058461|Biological|rituximab|Given IV
16380840|NCT00058461|Drug|carboplatin|Given IV
16380841|NCT00058461|Biological|filgrastim|Given SC
16380842|NCT00058461|Drug|methotrexate|Given IT
16380843|NCT00058461|Drug|cytarabine|Given IT
16380844|NCT00058461|Other|laboratory biomarker analysis|Correlative studies
16380845|NCT00058448|Drug|docetaxel|
16380846|NCT00058435|Biological|abagovomab|
16380847|NCT00058422|Biological|darbepoetin alfa|
16380848|NCT00058422|Biological|filgrastim|
16380849|NCT00058422|Biological|rituximab|
16380850|NCT00058422|Drug|cyclophosphamide|
16380851|NCT00058422|Drug|doxorubicin hydrochloride|
16380852|NCT00058422|Drug|prednisone|
16380853|NCT00058422|Drug|vincristine sulfate|
16380854|NCT00058422|Radiation|indium In 111 ibritumomab tiuxetan|
16380855|NCT00058422|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16380856|NCT00058396|Biological|lumiliximab|
16380857|NCT00058370|Drug|cisplatin|
16380858|NCT00058370|Drug|lomustine|
16380859|NCT00058370|Drug|vincristine sulfate|
16380860|NCT00058370|Procedure|adjuvant therapy|
16380861|NCT00058370|Radiation|iodine I 131 monoclonal antibody 3F8|
16380862|NCT00058370|Radiation|radiation therapy|
16380863|NCT00058357|Drug|lidocaine|
16380864|NCT00058357|Other|placebo|
16380865|NCT00058331|Biological|epoetin alfa|
16380866|NCT00058318|Drug|capecitabine|Capecitabine will be given 625 mg/m^2 (1250 mg/m^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression
16380990|NCT00057720|Drug|doxorubicin HCl liposome injection|
16382107|NCT00046969|Radiation|brachytherapy|
16380867|NCT00058318|Drug|gemcitabine hydrochloride|Gemcitabine will be given 900 mg/m^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.
16380868|NCT00058305|Drug|bryostatin 1|Given IV
16380869|NCT00058305|Drug|vincristine sulfate|Given IV
16380870|NCT00058305|Other|laboratory biomarker analysis|Correlative studies
16380871|NCT00058292|Biological|filgrastim|Given at a dose of 5 μg/kg, subcutaneously daily, beginning on Day 0 (stem cell transplant day) until white blood cells measure greater than 1500/ul.
16380872|NCT00058292|Biological|rituximab|Intravenous infusion of 250 mg/m2 on treatment days -22 and -14 (day 0 = stem cell transplant).
16380873|NCT00058292|Drug|Carmustine|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Carmustine is given at a dose of 300 mg/m2 intravenous infusion over a 2 hour period on treatment day -6 (Day 0 = stem cell transplant).
16380874|NCT00058292|Drug|cytarabine|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Cytarabine is given at a dose of 100 mg/m2 intravenous infusion over a 1 hour period, every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
16380875|NCT00058292|Drug|etoposide|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Etoposide is given at a dose of 100 mg/m2 intravenous infusion over a 2 hour period every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
16380876|NCT00058292|Drug|melphalan|Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Melphalan is given at a dose of 140 mg/m2 as an intravenous infusion over a 1 hour period on treatment day -1 (Day 0 = stem cell transplant).
16380877|NCT00058292|Procedure|peripheral blood stem cell transplantation|On day 0, a minimum of 2.0 X 106 CD34+ cells/kg unselected peripheral blood progenitor cells (PBPC) will be reinfused following institutional guidelines for the reinfusion procedure.
16380878|NCT00058292|Radiation|yttrium Y 90 ibritumomab tiuxetan|Patients will receive 90Y2B8 at a variable dose on treatment day -14 (Day 0 = stell cell transplant). The initial dose calculated to deliver no more than 100 cGy to critical organs (liver, lung). Doses will be escalated based on cohort of enrollment.
16380879|NCT00058279|Biological|aldesleukin|
16380880|NCT00058279|Biological|ipilimumab|
16380881|NCT00058266|Dietary Supplement|genistein|Given orally
16380882|NCT00058266|Procedure|conventional surgery|Patients undergo surgery
16380883|NCT00058253|Drug|tanespimycin|Given IV
16380884|NCT00058253|Drug|docetaxel|Given IV
16380885|NCT00058240|Drug|alvocidib|Given IV
16380886|NCT00058227|Drug|alvocidib|Given IV
16380887|NCT00058227|Drug|fludarabine phosphate|Given IV
16380888|NCT00058227|Biological|rituximab|Given IV
16380889|NCT00058227|Other|pharmacological study|Correlative studies
16380890|NCT00058214|Drug|perifosine|Given orally
16380891|NCT00058214|Other|laboratory biomarker analysis|Correlative studies
16380892|NCT00058201|Drug|fluorouracil|Given IV
16380893|NCT00058201|Drug|gemcitabine hydrochloride|Given IV
16380894|NCT00058201|Drug|leucovorin calcium|Given IV
16380895|NCT00058201|Other|clinical observation|No intervention
16380896|NCT00058188|Dietary Supplement|cholecalciferol|Given orally
16380897|NCT00058188|Drug|calcium gluconate|Given orally
16380898|NCT00058188|Drug|zoledronic acid|Given IV
16380899|NCT00058149|Drug|gemcitabine hydrochloride|
16380900|NCT00058149|Drug|oxaliplatin|
16380901|NCT00058123|Drug|poly ICLC|
16380902|NCT00058097|Drug|tipifarnib|Given orally
16380903|NCT00058097|Radiation|radiation therapy|Undergo radiation therapy
16380904|NCT00058084|Drug|ixabepilone|Given IV
16380905|NCT00058084|Drug|mitoxantrone hydrochloride|Given IV
16380906|NCT00058084|Drug|prednisone|Given orally
16380907|NCT00058071|Drug|amifostine trihydrate|
16380908|NCT00058058|Procedure|MRI|Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.
16380909|NCT00058045|Biological|aldesleukin|
16380910|NCT00058045|Biological|recombinant human stem cell factor|
16380911|NCT00058032|Other|screening questionnaire administration|
16380912|NCT00058032|Procedure|annual screening|
16380913|NCT00058019|Drug|ixabepilone|Given IV
16380914|NCT00058006|Drug|celecoxib|
16380915|NCT00058006|Procedure|adjuvant therapy|
16380916|NCT00057993|Biological|trastuzumab|
16380917|NCT00057993|Drug|exemestane|
16380918|NCT00057980|Drug|celecoxib|
16380919|NCT00057980|Drug|epirubicin hydrochloride|
16380920|NCT00057967|Biological|alemtuzumab|Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks.
16380921|NCT00057954|Procedure|Extracorporeal Photopheresis|Day -7 to -4: Extracorporeal Photopheresis may be given as an outpatient therapy on two consecutive days any time between days -7 to -4. This must be performed on UVAR or XTS photopheresis machines (Therakos, Inc.) according to standard procedure as per manufacturer's guidelines.
16380922|NCT00057954|Drug|Pentostatin|Day -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²)
16380923|NCT00057954|Radiation|Total body irradiation (TBI)|Day -1: TBI 400 cGy total dose given in two 200cGy doses. Patients who have received TBI for a previous transplant or radiation as part of previous treatment for a lymphoid malignancy will receive only 200 cGy in 1 dose.
16380924|NCT00057954|Procedure|Allogeneic bone marrow transplantation|Day 0: Infusion of unmanipulated allogeneic bone marrow or stem cells. Minimum cell dose of 2 x 106 CD34 cells/kg recipient and no more than 10 x 10^6 CD34/kg
16380925|NCT00057954|Drug|Cyclosporin (CSA)|Cyclosporin A or tacrolimus will be administered according to institutional GVHD prophylaxis protocols. Therapeutic levels will be maintained and patients will be switched to oral agents when they can tolerate
16381478|NCT00054158|Drug|dexamethasone|
16380926|NCT00057954|Drug|Mycophenolate mofetil (MMF)|At day 100 MMF will be introduced at a dose of 250 mg po BID and cyclosporine or tacrolimus will be tapered according to the discretion of the investigator. The dosage will be escalated to a maximum of 2 g/d at the discretion of the attending physician and will be tapered and discontinued at 12 months if there is no active cGVHD. Doses should be given on an empty stomach
16380927|NCT00057954|Drug|Methotrexate (MTX)|"The dose of Methotrexate is based on the corrected ideal body weight for patients with > 33% above ideal weight.
~Day +1 MTX 15 mg/m² IV push; Day +3 MTX 10 mg/m² IV push (May be omitted if patient develops mouth sores.)"
16380928|NCT00057941|Drug|anastrozole|Given orally
16380929|NCT00057941|Drug|gefitinib|Given orally
16380930|NCT00057941|Drug|fulvestrant|Given intramuscularly
16380931|NCT00057941|Other|laboratory biomarker analysis|Correlative studies
16380932|NCT00057928|Drug|cisplatin|
16380933|NCT00057928|Drug|gemcitabine hydrochloride|
16380934|NCT00057928|Drug|paclitaxel|
16380935|NCT00057915|Biological|CEA peptide 1-6D|CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
16380936|NCT00057889|Biological|ipilimumab|
16380937|NCT00057876|Drug|Gemcitabine|"Induction: Patients receive the first cycle of gemcitabine 1000 mg/m^2 intravenously once per week for 6 weeks followed by 1 week rest.
~Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
16380938|NCT00057876|Radiation|radiation therapy|"Induction: Patients receive gemcitabine 600 mg/m^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks.
~Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy."
16380939|NCT00057863|Drug|Paclitaxel|Given IV
16380940|NCT00057863|Drug|Oxaliplatin|Given IV
16380941|NCT00057850|Drug|cisplatin|
16380942|NCT00057850|Drug|ixabepilone|
16380943|NCT00057837|Biological|G-CSF|G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery > 10,000 dL.
16380944|NCT00057837|Drug|Cisplatin|Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.
16380945|NCT00057837|Drug|Etoposide|Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.
16380946|NCT00057837|Drug|Irinotecan|50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).
16380947|NCT00057837|Drug|Topotecan|Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).
16380948|NCT00057811|Drug|doxorubicin hydrochloride|Given IV, IT, or orally
16380949|NCT00057811|Drug|cyclophosphamide|Given IV
16380950|NCT00057811|Drug|methotrexate|Given IV or IT
16380951|NCT00057811|Drug|rasburicase|Given IV
16380952|NCT00057811|Drug|leucovorin calcium|Given IV or orally
16380953|NCT00057811|Drug|prednisone|Given IV or orally
16380954|NCT00057811|Drug|methylprednisolone|Given IV or orally
16380955|NCT00057811|Biological|filgrastim|Given subcutaneously
16380956|NCT00057811|Biological|rituximab|Given IV
16380957|NCT00057811|Drug|cytarabine|Given IT
16380958|NCT00057811|Drug|etoposide|Given IV
16380959|NCT00057811|Drug|vincristine sulfate|Given IV
16380960|NCT00057811|Drug|hydrocortisone sodium succinate|Given IT
16380961|NCT00057811|Other|laboratory biomarker analysis|Correlative studies
16380962|NCT00057798|Drug|gemcitabine hydrochloride|
16380963|NCT00057798|Drug|vinorelbine ditartrate|
16380964|NCT00057798|Genetic|cytogenetic analysis|
16380965|NCT00057798|Genetic|loss of heterozygosity analysis|
16380966|NCT00057798|Genetic|microarray analysis|
16380967|NCT00057798|Procedure|conventional surgery|
16380968|NCT00057798|Procedure|neoadjuvant therapy|
16380969|NCT00057785|Drug|cisplatin|100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
16380970|NCT00057785|Drug|fluorouracil|1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
16380971|NCT00057785|Radiation|Intensity modulated radiation therapy|The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.
16380972|NCT00057759|Drug|sildenafil citrate|
16380973|NCT00057759|Other|Placebo|Placebo
16380974|NCT00057746|Radiation|Prophylactic cranial irradiation, 2.5 Gy fx|Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
16380975|NCT00057746|Radiation|Prophylactic cranial irradiation, 2.0 Gy fx|Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
16380976|NCT00057746|Radiation|Prophylactic cranial irradiation, 1.5 Gy fx|Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
16380977|NCT00057733|Procedure|psychosocial assessment and care|
16380978|NCT00057733|Procedure|quality-of-life assessment|
16380979|NCT00030368|Drug|bortezomib|Given IV
16380980|NCT00030368|Drug|paclitaxel|Given IV
16380981|NCT00030368|Other|laboratory biomarker analysis|Correlative studies
16380982|NCT00023673|Drug|carboplatin|
16380983|NCT00023673|Drug|paclitaxel|
16380984|NCT00023673|Radiation|three-dimensional conformal radiation therapy|
16380985|NCT00004079|Drug|SarCNU|Given PO
16380986|NCT00004079|Other|pharmacological study|Correlative studies
16380987|NCT00004079|Other|laboratory biomarker analysis|Correlative studies
16380988|NCT00057720|Drug|TLK286 HCl for injection|
16380989|NCT00057720|Drug|topotecan hydrochloride for injection|
16380991|NCT00057681|Drug|Lithium carbonate|Titrated until blood level is 1.1 to 1.3 mEq/L
16380992|NCT00057681|Drug|Valproate|Titrated until blood level is 111 to 125 ug/mL
16380993|NCT00057681|Drug|Risperidone|Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
16380994|NCT00057668|Behavioral|Multi-Setting Early Intervention|
16380995|NCT00057668|Behavioral|Community Intervention|
16380996|NCT00057642|Drug|Sertraline|
16380997|NCT00057642|Drug|Venlafaxine Extended Release|
16380998|NCT00057629|Behavioral|Prolonged Exposure (PE)|Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
16380999|NCT00057629|Behavioral|Treatment as usual group therapy (TUGT)|TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.
16381000|NCT00057629|Behavioral|Supportive counseling (SC)|Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these. No instructions for exposure are given.
16381001|NCT00057616|Drug|CC-5013|
16381002|NCT00057603|Procedure|Deep Brain Stimulation|Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
16381003|NCT00057590|Behavioral|Care manager outreach and monitoring|
16381004|NCT00057577|Behavioral|Cognitive Therapy|CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
16381005|NCT00057577|Drug|Medications|Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
16381006|NCT00057564|Drug|A (Thalidomide + Dexamethasone)|Thalidomide 50mg/day + Dexamethasone 40mg
16381007|NCT00057564|Drug|B (Placebo + Dexamethasone)|Placebo + Dexamethasone 40mg
16381008|NCT00057707|Drug|Modafinil|Placebo 1 week-Wash out 1 week - Drug 1 week (or vice versa)
16381009|NCT00057707|Procedure|Functional MRI|
16381010|NCT00057707|Procedure|Neuropsychological Testing|
16381011|NCT00057551|Behavioral|Brief Supportive Psychotherapy|brief supportive psychotherapy
16381012|NCT00057551|Behavioral|CBASP|psychotherapy developed for chronic depression
16381013|NCT00057551|Drug|Medication Only|antidepressant medication
16381014|NCT00057538|Behavioral|Mantram Repetition|
16381015|NCT00057525|Biological|Anthrax|Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
16381016|NCT00057525|Biological|Alhdryogel or PBS|Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
16381017|NCT00057512|Drug|M4N|Dose escalation study of M4N administered intratumorally on days 1, 8 and 15. Dose escalated in cohorts on three weeks schedule to a target of 20 mg/cm3 tumor volume.
16381018|NCT00057499|Biological|IBC-VS01|IBC-VS01
16381019|NCT00057499|Biological|IBC-VS01 placebo|IBC-VS01 placebo
16381020|NCT00057486|Drug|IL-12|
16381021|NCT00057473|Drug|carboplatin + irinotecan|Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.
16381022|NCT00057473|Drug|irinotecan|Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.
16381023|NCT00057447|Drug|Interferon Gamma-1b|100 or 200 mcg, SQ, 3x per week
16381024|NCT00057447|Drug|Rituximab|375 mg per square meters, IV, 1x per week
16381025|NCT00057434|Drug|multivitamin|
16381026|NCT00057421|Drug|prednisolone|
16381027|NCT00057460|Drug|Talampanel|
16381028|NCT00057408|Drug|olanzapine (Zyprexa)|Olanzapine tablets given po at a dosage of 2.5 - 20 mg per day for up to 12 weeks.
16381029|NCT00057408|Drug|Placebo|Matching Placebo
16381030|NCT00057395|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
16381031|NCT00057382|Drug|T138067 intravenous|
16381032|NCT00057382|Drug|doxorubicin intravenous|
16381033|NCT00057369|Drug|dalbavancin|
16381034|NCT00057356|Drug|conivaptan|IV
16381035|NCT00057356|Drug|placebo|IV
16381036|NCT00057343|Drug|Zevalin (ibritumomab tiuxetan)|
16381037|NCT00057343|Drug|Rituxan (rituximab)|
16381038|NCT00057330|Biological|HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine|the vaccine was administered intramuscularly in the non-dominant deltoid
16381039|NCT00057330|Biological|Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine|the vaccine was administered intramuscularly in the non-dominant deltoid
16381040|NCT00057317|Drug|Ro 205-2349|
16381041|NCT00057304|Drug|Insulin sensitizer|
16381042|NCT00057291|Behavioral|Responsive caregiving|Responsive caregiving consisted of operational circumstances and training of caregivers.
16381043|NCT00057031|Drug|DN-101 (calcitriol)|
16381044|NCT00057278|Drug|gabapentin|
16381045|NCT00057265|Drug|telbivudine or lamivudine|
16381046|NCT00057200|Procedure|Telephone, videophone care|
16381047|NCT00057187|Behavioral|Contracting, Prompting and Reinforcing|
16381048|NCT00057239|Drug|Radafaxine|
16381049|NCT00057226|Drug|Radafaxine|
16381050|NCT00057213|Drug|Radafaxine|
16381051|NCT00057174|Drug|Disease management of gastroesophageal reflux disease|
16381052|NCT00057161|Behavioral|Coordinated Representative Payeeship with Case Management|
16381053|NCT00057148|Procedure|massage treatment|
16381054|NCT00057135|Behavioral|Unit of use medication packaging|
16381055|NCT00057135|Behavioral|Mailed reminders to patient when medication refills are due|
16381056|NCT00057135|Behavioral|Note to Mental Health Provider when refill is overdue|
16381057|NCT00057135|Procedure|Aligning all prescriptions to fall due on same date|
16381058|NCT00057122|Drug|Isoniazid|300mg
16381059|NCT00057122|Drug|Rifapentine|Rifapentine 900 mg
16381060|NCT00057122|Drug|Rifampin|Rifampin 600 mg
16381061|NCT00057096|Procedure|On-site vs. referral methods of care|
16381062|NCT00057083|Other|Telemedicine Care|
16381063|NCT00057070|Procedure|Smoking cessation information, collection, and dissemination|
16381064|NCT00057057|Behavioral|Telephone Care|
16381065|NCT00057044|Behavioral|education and reminder|
16381066|NCT00057018|Procedure|Constraint-induced movement therapy|
16381067|NCT00057005|Drug|CAMPATH-1H|Day-8 through Day-6 according to institutional SOPs
16381068|NCT00057005|Drug|Anti-CD45|Day-5 400 μg/kg
16381069|NCT00057005|Drug|Ara-C|day-7 through day-5 3000 mg/m2 q 12h
16381070|NCT00057005|Drug|Cyclophosphamide|Day-7 through Day-6 45 mg/kg
16381071|NCT00057005|Drug|Mesna|Days -7 and -6 45 mg/kg divided into 5 doses
16381072|NCT00057005|Radiation|Total Body Irradiation|150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)
16381073|NCT00056992|Drug|ADI-PEG 20|
16381074|NCT00056979|Drug|CAMPATH-1H|
16381075|NCT00056979|Drug|Anti-CD45|
16381076|NCT00056979|Drug|FK506|
16381077|NCT00056979|Drug|Fludarabine|
16381078|NCT00056966|Drug|ANTI-CD45|400ug/kg Day-5 through Day-2
16381079|NCT00056966|Drug|CAMPATH-1H|Day -8 through Day -6 Dosed per Institutional SOP
16381080|NCT00056966|Drug|FK506|Day -2 through Day 30 dose adjusted to maintain level between 5-15 ng/ml.
16381081|NCT00056966|Drug|Fludarabine|Day-8 through Day-5 30 mg/m2
16381082|NCT00056966|Radiation|Total Body Irradiation|Day-1 single dose 450 cGy
16381083|NCT00056966|Procedure|Stem cell infusion|Patients will receive peripheral blood stem cells from a HLA matched or one antigen mismatched related or unrelated donor (target CD34+ cell count >2 x 106/kg). When peripheral stem cells are unavailable or insufficient, bone marrow (target mononuclear cell count >2 x 108/kg) will be substituted.
16381084|NCT00056953|Behavioral|Peer mentoring program|
16381085|NCT00056940|Behavioral|Stages of Change|
16381086|NCT00056940|Behavioral|Safety Check approach|
16381087|NCT00056927|Behavioral|Anti-smoking Socialization Program|
16381088|NCT00056875|Drug|recombinant human keratinocyte growth factor|
16381089|NCT00056836|Drug|rhuFab V2 (ranibizumab)|
16381090|NCT00056823|Drug|rhuFab V2 (ranibizumab)|
16381091|NCT00056862|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 90 mcg/week
16381092|NCT00056862|Drug|Peginterferon alfa-2a|180 mcg/week
16381093|NCT00056862|Drug|Ribavirin|800 mg/day
16381094|NCT00056810|Drug|4-aminopyridine (4-AP)|
16381095|NCT00056797|Biological|ALVAC HIV vaccine (vCP1452)|
16381096|NCT00056797|Drug|Interleukin-2|
16381097|NCT00056758|Biological|Autologous Dendritic Cell HIV Vaccination|
16381098|NCT00056745|Biological|TBC-3B|
16381099|NCT00056693|Drug|Sunitinib|Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
16381100|NCT00056680|Behavioral|Psychoeducational video|
16381101|NCT00056680|Behavioral|Infant massage|
16381102|NCT00056680|Behavioral|Brazelton Neonatal Behavioral Assessment Scale|
16381103|NCT00056667|Behavioral|Relaxation response and cognitive behavioral therapy|The cognitive behavioral therapy program wwill incorporate relaxation training, a modified version of the RA treatment program developed by Bradley et al (1987) and shown to be effective. The cognitive behavioral techniques include problem solving, relabeling, enhanced awareness of pain behaviors, and attention refocusing. The RR component includes instruction in diaphragmatic breathing along with progressive skeletal muscle relaxation. The intervention will be modified from the original program in that neither biofeedback training nor participation of family members will be included. Consequently, the number of weekly group sessions will be reduced from 14 to 12. Homework will be given at the end of each session, to be completed and brought in for review to the next session.
16381104|NCT00056667|Behavioral|Relaxation response|The relaxation response (RR) consists of a set of integrated physiological changes elicited when a participant engages in the repetitive mental action of focusing on a word, phrase, or image, while passively ignoring distracting thoughts. These changes include decreased oxygen consumption, heart rate, arterial blood pressure, respiratory rate, and arterial blood lactate, along with slight increases in skeletal muscle blood flow. The long-term physiologic changes of participants eliciting the relaxation response are consistent with reduced norepinephrine end organ responsivity. These latter changes provide a plausible psychophysiological mechanism for longer-term actions of the RR.
16381105|NCT00056667|Other|RA education|RA education programs have been widely used to supplement routine medical care. They have been found to be of modest benefit, particularly in terms of knowledge about the condition and its treatment. The long-term effects on pain and level of function are less. When used as an attention control, such educational programs have been found to be as credible and as well attended as the active experimental treatment (Professor Francis Keefe, Personal Communication). In this study, patients randomized to the control condition will receive 8 weekly sessions of RA education, in groups of 6-10 patients each, using portions of the Arthritis Self-Management Program and incorporating printed and videotaped materials available from the Arthritis Foundation.
16381106|NCT00056654|Drug|Leuprolide acetate|45 mg Intramuscular injection 6 month depot formulation
16381107|NCT00056641|Drug|tipranavir|
16381108|NCT00056641|Drug|ritonavir|
16381109|NCT00056641|Drug|saquinavir|
16381110|NCT00056641|Drug|amprenavir|
16381111|NCT00056641|Drug|lopinavir|
16381112|NCT00056706|Procedure|Transient deafferentation|
16381113|NCT00056628|Device|The COGNIShunt® System|
16381114|NCT00056589|Drug|catridecacog|Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
16381115|NCT00056576|Drug|Zonisamide|
16381116|NCT00056563|Device|Bilateral Deep Brain Stimulation|The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.
16381117|NCT00056563|Other|best medical therapy|"Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
16381118|NCT00056550|Biological|Recombinant Human Antithrombin (rhAT)|Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
16381119|NCT00056537|Drug|ABR-217620|Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles
16381120|NCT00056524|Drug|AVP-923|
16381121|NCT00056511|Drug|Fresh garlic or garlic supplements|
16381122|NCT00056498|Drug|Placebo|Placebo capsule daily for 16 weeks
16381123|NCT00056498|Drug|Risperdal|Risperdal 4 mg per day for 16 weeks
16381124|NCT00056485|Behavioral|Pleasant Events-Based Behavioral Intervention|
16381125|NCT00056472|Drug|Olanzapine|10-20mg/day
16381126|NCT00056472|Drug|Sertraline|150-200mg/day
16381127|NCT00056472|Other|placebo|tablet that ressembles sertraline but contains no medication
16381128|NCT00012454|Drug|E-Selectin nasal spray|
16381129|NCT00056459|Drug|Vatalanib|
16381130|NCT00056446|Drug|Vatalanib|
16381131|NCT00056433|Drug|Hydroxyurea|
16381132|NCT00056433|Drug|L-Arginine|
16381133|NCT00056433|Drug|Sildenafil|
16381134|NCT00056407|Drug|Dutasteride|After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.
16381135|NCT00056407|Drug|Placebo|After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
16381136|NCT00056394|Behavioral|Comprehensive Coping Skills Training|10 weekly, 80-minute coping skills treatment sessions, followed by a series of six biweekly follow-up telephone calls.
16381137|NCT00056394|Behavioral|Arthritis Education Sessions|10 weekly, 80-minute treatment sessions, followed by a series of six biweekly follow-up telephone calls. Participants will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection.
16381138|NCT00056394|Behavioral|Standard Care|Usual care from participants' rheumatologists but no treatment sessions.
16381139|NCT00056381|Drug|Anidulafungin|
16381140|NCT00056368|Drug|Anidulafungin|
16381141|NCT00056368|Drug|Fluconazole|
16381142|NCT00056329|Drug|Vitamin E|1,000 international units twice daily for three years
16381143|NCT00056329|Drug|multivitamin|once daily for three years
16381144|NCT00056329|Drug|Placebo|Placebo twice daily for three years
16381145|NCT00056355|Drug|UVADEX and UVAR XTS Photopheresis System|
16381146|NCT00056316|Behavioral|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
16381147|NCT00056316|Behavioral|Behavioral Skills Training: Experimental|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
16381148|NCT00056303|Behavioral|Attachment and Biobehavioral Catch-up|Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
16381149|NCT00056303|Behavioral|Developmental Education for Families|Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
16381150|NCT00056290|Biological|VEGF|3 sets of injections, at 2 week intervals
16381151|NCT00056290|Biological|VEGF|3 sets of injections, at 2 week intervals
16381152|NCT00056277|Drug|lamotrigine|
16381153|NCT00056264|Drug|Infliximab|
16381154|NCT00056251|Procedure|H&P; ECG; Blood tests; voiding diary; Cystoscopy|
16381155|NCT00056238|Drug|NC-758 (Anti amyloidotic [Aß] agent)|
16381156|NCT00056225|Drug|Folate|
16381157|NCT00056225|Drug|Vitamin B6|
16381158|NCT00056225|Drug|Vitamin B12|
16381159|NCT00056212|Behavioral|Yoga|
16381160|NCT00056212|Behavioral|Exercise|
16381161|NCT00056173|Drug|GTI-2040|
16381162|NCT00056199|Drug|EYE001|
16381163|NCT00056160|Drug|CC-5013|Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
16381164|NCT00056160|Drug|Dexamethasone|Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
16381165|NCT00056147|Drug|denufosol tetrasodium (INS37217)|
16381166|NCT00056134|Biological|Dendritic cell vaccine plus denileukin difitox|
16381167|NCT00056095|Biological|therapeutic allogeneic lymphocytes|
16381168|NCT00056095|Drug|cyclophosphamide|
16381169|NCT00056095|Drug|cyclosporine|
16381170|NCT00056095|Drug|fludarabine phosphate|
16381171|NCT00056095|Procedure|allogeneic bone marrow transplantation|
16381172|NCT00056095|Procedure|peripheral blood stem cell transplantation|
16381173|NCT00056082|Drug|celecoxib|Celecoxib daily for 12 months
16381174|NCT00056069|Other|questionnaire administration|Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment.
16381175|NCT00056056|Drug|bexarotene|The recommended initial dosage of Bexarotene (75 mg Bexarotene capsules to be administered according to body surface area) for patients entered in this trial is 300 mg/m2 /once a day, taken orally, till CCR, PD, unacceptable toxicity, 16 weeks of treatment, whichever comes first
16381176|NCT00056056|Drug|methoxypsoralen|The dose of methoxypsoralen, as conventional capsules or liquid-filled capsules, is based on the patient's weight. The standard dose of 0.6 mg/kg will be given to all patients three times weekly - Increasing dose of PUVA according to a set protocol after a Minimal Phototoxic Dose (MPD) testing.
16381177|NCT00056056|Procedure|UV light therapy|Initial UVA light exposure times should be based on the minimal phototoxic dose (MPD) for the specific light source being used. MPD can be determined by irradiating several skin areas 2 cm in diameter with varying light exposure times and determining the exposure time that produces erythema at 72 hours. The initial dose of UVA administered will be 70% of the MPD. The dose of UVA for the subsequent UVA sessions will be increased according to a standard protocol consisting of 20% increments with each successive treatment session depending on the presence of erythema.
16381178|NCT00056030|Biological|cetuximab|
16381179|NCT00056030|Drug|fluorouracil|
16381180|NCT00056030|Drug|leucovorin calcium|
16381181|NCT00056030|Drug|oxaliplatin|
16381182|NCT00056004|Drug|zileuton|
16381183|NCT00055991|Drug|bexarotene|This drug is a retinoid. The anti-tumor action of retinoids, as well as their potential in chemoprevention, supports the need to further identify the spectrum of responsive tumors, to identify the molecular mechanisms associated with retinoid action, and to identify and develop new retinoids that have unique properties and an improved therapeutic index.
16381184|NCT00055978|Drug|celecoxib|Given orally. 400mg twice daily for 6 months.
16381185|NCT00055978|Other|placebo|Given orally
16381186|NCT00055965|Drug|carboplatin|
16381187|NCT00055965|Drug|cisplatin|
16381188|NCT00055965|Drug|gemcitabine hydrochloride|
16381189|NCT00055952|Drug|exatecan mesylate|
16381190|NCT00055939|Drug|exatecan mesylate|
16381191|NCT00055926|Drug|CP-724,714|
16381192|NCT00055913|Biological|bevacizumab|Given IV
16381193|NCT00055913|Drug|erlotinib hydrochloride|Given orally
16381194|NCT00055913|Other|laboratory biomarker analysis|Correlative studies
16381195|NCT00055887|Drug|carboplatin|
16381196|NCT00055887|Drug|cisplatin|
16381197|NCT00055887|Drug|efaproxiral|
16381198|NCT00055887|Drug|gemcitabine hydrochloride|
16381199|NCT00055887|Drug|paclitaxel|
16381200|NCT00055887|Drug|vinorelbine ditartrate|
16381201|NCT00055887|Procedure|radiation therapy|
16381202|NCT00055874|Biological|recombinant interferon alfa|
16381203|NCT00055874|Drug|cytarabine|
16381204|NCT00055874|Drug|hydroxyurea|
16381205|NCT00055874|Drug|imatinib mesylate|
16381206|NCT00055874|Procedure|allogeneic bone marrow transplantation|
16381207|NCT00055874|Procedure|autologous bone marrow transplantation|
16381208|NCT00055874|Procedure|peripheral blood stem cell transplantation|
16381209|NCT00055861|Biological|bevacizumab|Given IV
16381210|NCT00055861|Drug|docetaxel|Given IV
16381211|NCT00055861|Other|laboratory biomarker analysis|Correlative studies
16381212|NCT00055848|Genetic|cytogenetic analysis|
16381213|NCT00055848|Genetic|gene mapping|
16381214|NCT00055848|Genetic|microarray analysis|
16381215|NCT00055835|Drug|carboplatin|*AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
16381216|NCT00055835|Drug|cisplatin|75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)
16381217|NCT00055835|Drug|gemcitabine hydrochloride|800 mg/m2, IV, over 30 minutes; given on Days 1 & 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)
16381218|NCT00055835|Drug|paclitaxel|200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
16381219|NCT00055835|Procedure|neoadjuvant therapy|Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)
16381220|NCT00055835|Radiation|radiation therapy|Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.
16381221|NCT00055822|Biological|oblimersen sodium|
16381222|NCT00055822|Drug|fluorouracil|
16381223|NCT00055822|Drug|leucovorin calcium|
16381224|NCT00055822|Drug|oxaliplatin|
16381225|NCT00055809|Biological|PEG-interferon alfa-2b|Given SC
16381226|NCT00055809|Biological|bevacizumab|Given IV
16381227|NCT00055809|Other|laboratory biomarker analysis|Optional correlative studies
16381228|NCT00055783|Biological|apolizumab|
16381229|NCT00055770|Drug|erlotinib hydrochloride|Given orally
16381230|NCT00055770|Drug|docetaxel|Given IV
16381231|NCT00055770|Other|laboratory biomarker analysis|Correlative studies
16381232|NCT00055770|Other|pharmacological study|Correlative studies
16381233|NCT00055757|Drug|tipifarnib|Given orally
16381234|NCT00055757|Drug|cisplatin|Given IV
16381235|NCT00055757|Drug|gemcitabine hydrochloride|Given IV
16381236|NCT00055757|Other|laboratory biomarker analysis|Correlative studies
16381237|NCT00055731|Drug|bicalutamide|
16381238|NCT00055731|Drug|Goserelin Acetate|
16381239|NCT00055731|Drug|docetaxel|
16381240|NCT00055731|Drug|Estramustine phosphate sodium|
16381241|NCT00055731|Drug|acetylsalicylic acid|
16381242|NCT00055731|Procedure|conventional surgery|
16381243|NCT00055731|Radiation|radiation therapy|
16381244|NCT00055718|Dietary Supplement|silymarin|
16381245|NCT00055705|Biological|PV701|
16381246|NCT00055692|Biological|bevacizumab|Given orally
16381247|NCT00055679|Drug|cyclophosphamide|
16381248|NCT00055679|Drug|epirubicin hydrochloride|
16381249|NCT00055679|Drug|fluorouracil|
16381250|NCT00055666|Drug|beclomethasone dipropionate|
16381251|NCT00055653|Biological|anti-thymocyte globulin|
16381252|NCT00055653|Biological|filgrastim|
16381253|NCT00055653|Drug|busulfan|
16381254|NCT00055653|Drug|cyclophosphamide|
16381255|NCT00055653|Drug|cyclosporine|
16381256|NCT00055653|Drug|fludarabine phosphate|
16381257|NCT00055653|Drug|melphalan|
16381258|NCT00055653|Drug|methylprednisolone|
16381259|NCT00055653|Procedure|umbilical cord blood transplantation|
16381260|NCT00055653|Radiation|radiation therapy|
16381261|NCT00055640|Biological|rituximab|Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
16381262|NCT00055640|Drug|cyclophosphamide|Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
16381263|NCT00055640|Drug|doxorubicin hydrochloride|Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
16381264|NCT00055640|Drug|prednisone|Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
16381265|NCT00055640|Drug|vincristine sulfate|Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
16381266|NCT00055640|Genetic|microarray analysis|genetic testing
16381267|NCT00055614|Drug|topotecan hydrochloride|
16381268|NCT00055614|Procedure|adjuvant therapy|
16381269|NCT00055601|Drug|cisplatin|Induction: 15 mg/m2 as a 60-minute infusion on days 1, 2, 3, 8, 9, 10, 15, 16, and 17; Consolidation: 15 mg/m2 as a 60-minute infusion on days 1, 2, 8, and 9; Adjuvant: 35 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.
16381270|NCT00055601|Drug|fluorouracil|Induction: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 15, 16, and 17; Consolidation: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 8, 9, and 10.
16381271|NCT00055601|Drug|paclitaxel|Induction: 50 mg/m2 as a 60-minute infusion on days 1, 8, and 15; Consolidation: 50 mg/m2 as a 60-minute infusion on days 1 and 8; Adjuvant: 50 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.
16381272|NCT00055601|Radiation|radiation therapy|Induction: External beam irradiation, 1.6 Gy, will be given to the pelvis in the first treatment followed by an interfraction period of at least 4-6 hours. During the second treatment, 1.5 Gy will be delivered to the whole bladder for the first five sessions (7.5 Gy) then to the tumor plus a margin for eight sessions (12. Gy). Consolidation: Consolidation therapy will start 7-14 days following a cystoscopic re-evaluation demonstrating a complete response to the induction therapy. 1.5 Gy (per fraction) will be given to the pelvis in two treatment fractions per day, with an interfraction period of at least 4-6 hours.
16381273|NCT00055601|Drug|Gemcitabine|Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.
16381274|NCT00055601|Procedure|Radical cystectomy|Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.
16381275|NCT00022139|Drug|carboplatin|
16381276|NCT00022139|Drug|fluorouracil|
16381277|NCT00022139|Drug|paclitaxel|
16381278|NCT00022139|Procedure|conventional surgery|
16381279|NCT00022139|Radiation|radiation therapy|
16381280|NCT00005028|Drug|bryostatin 1|
16381281|NCT00005028|Drug|paclitaxel|
16381282|NCT00055588|Procedure|Locomotor training|
16381283|NCT00055575|Drug|Scopolamine Nasal Spray|
16381284|NCT00055562|Drug|CC 5013|
16381285|NCT00055536|Drug|natalizumab|
16381286|NCT00055523|Drug|Adalimumab (D2E7)|
16381287|NCT00055549|Drug|Dextromethorphan|
16381288|NCT00055549|Drug|Lorazepam|
16381289|NCT00055510|Drug|BO-653|
16381290|NCT00055497|Biological|Double-blind (DB) adalimumab placebo|Double-blind nonactive matching subcutaneous injection
16381291|NCT00055497|Biological|DB adalimumab 40 mg eow|Double-blind adalimumab 40 mg every other week by subcutaneous injection
16381292|NCT00055497|Biological|DB adalimumab 40 mg ew|Double-blind adalimumab 40 mg every week by subcutaneous injection
16381293|NCT00055497|Biological|OL adalimumab 40 mg|Open-label adalimumab every other week or every week by subcutaneous injection
16381294|NCT00055484|Drug|zonisamide|
16381295|NCT00055471|Drug|ZD4054 10 mg|1 x 10 mg oral tablets once daily
16381296|NCT00055471|Drug|ZD4054 15 mg|1 x 10 mg + 2 x 2.5 mg oral tablets once daily
16381297|NCT00055471|Drug|ZD4054 22.5 mg|2 x 10 mg + 2 x 2.5 mg oral tablets once daily
16381298|NCT00055445|Drug|IdB 1016|
16381299|NCT00055432|Drug|Gemzar and Alimta|
16381300|NCT00055419|Biological|Cetuximab|400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
16381301|NCT00055393|Drug|Bupropion|18 subjects in this randomly controlled double blind study received bupropion.
16381302|NCT00055393|Drug|Placebo|21 subjects received Placebo.
16381303|NCT00055380|Procedure|Oral cytobrushing|
16381304|NCT00055367|Drug|natalizumab|
16381305|NCT00055354|Procedure|Acupuncture|
16381306|NCT00055354|Behavioral|Cognitive Behavioral Therapy|
16381307|NCT00055341|Drug|Peginterferon alfa-2a|
16381308|NCT00055341|Drug|Ribavirin|
16381309|NCT00055328|Behavioral|Problem-Solving Treatment for Primary Care|
16381310|NCT00055315|Behavioral|Systems Training for Emotional Predictability and Problem Solving (STEPPS)|STEPPS is a 20-week, manual-based, psychoeducational group treatment that combines skills training with cognitive-behavioral techniques. It includes a systems component to train family members, friends, and significant others.
16381311|NCT00055315|Behavioral|Treatment As Usual (TAU)|
16381312|NCT00055302|Drug|Arimidex 1 mg|Arimidex (anastrozole) 1mg once daily by mouth
16381313|NCT00055263|Drug|DN-101|
16381314|NCT00055250|Drug|Gemcitabine|
16381315|NCT00055250|Drug|LY293111|
16381316|NCT00055250|Drug|placebo|
16381317|NCT00055237|Biological|Bevacizumab|15 mg/kg day intravenously on day 1, day 8, then every 3 weeks.
16381320|NCT00055198|Drug|daptomycin|
16381321|NCT00055185|Drug|CD4-IgG2 (PRO 542)|
16381322|NCT00055146|Drug|ONTAK|
16381323|NCT00055133|Drug|Micellar Paclitaxel for Injection|
16381324|NCT00055159|Procedure|Pulse-sprayed injection of recombinant tissue plasminogen activator (rtPA)|
16381325|NCT00055120|Drug|Emtricitabine/tenofovir disoproxil fumarate|
16381326|NCT00055120|Drug|Lopinavir/ritonavir|
16381327|NCT00055120|Drug|Stavudine|
16381328|NCT00055107|Drug|Nitazoxanide|
16381329|NCT00055081|Behavioral|Critical Time Intervention|
16381330|NCT00055068|Behavioral|Cognitive Behavioral Therapy (CBT)|
16381331|NCT00055068|Behavioral|Relaxation Training|
16381332|NCT00055042|Drug|Vitamin E|
16381333|NCT00054977|Drug|GM-CT-01|IV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle.
16381334|NCT00054977|Drug|5-fluorouracil|IV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle.
16381335|NCT00054964|Drug|Albuterol HFA-BOI|Albuterol HFA breath operated inhaler, 90 mcg/sprau
16381336|NCT00054964|Drug|Albuterol HFA-MDI|Albuterol HFA multi-dose inhaler
16381337|NCT00054951|Drug|MTC-DOX for Injection|
16381338|NCT00054938|Drug|pravastatin|
16381339|NCT00054938|Drug|aspirin|
16381340|NCT00054938|Drug|ramipril|
16381341|NCT00054938|Drug|Vitamins: B6, B12, and folate|
16381342|NCT00054938|Behavioral|heart health educational program|
16381343|NCT00054925|Behavioral|Personal contact (PC)|This arm uses brief, individual contacts on a monthly basis which emphasize core elements of weight maintenance. Monthly contacts with an interventionist occur for 30 months after the end of Phase I. Face-to-face contacts occur approximately every four months (e.g., three annually), with telephone contacts occurring every month between FTF contacts.
16381344|NCT00054925|Behavioral|Interactive technology (IT)|The website utilizes collaborative goal setting and problem-solving strategies to identify contingent action plans for perceived obstacles to success. In order to tailor the intervention to the needs of the participant, the action plan can be updated anytime and as frequently as desired by the individual. Participants are encouraged to input data on weight, food records, physical activity, and goals on a weekly basis. Participants are not restricted to logging on to the website only once a week. Rather, participants have the option of logging on to the website to enter data, communicate with other participants, or to seek other information, as frequently as they wish.
16381345|NCT00054912|Biological|EP2101|
16381346|NCT00054899|Biological|EP2101|
16381347|NCT00054886|Drug|SU-011,248|
16381348|NCT00054873|Drug|tezacitabine|
16381349|NCT00054873|Drug|5-fluorouracil|
16381350|NCT00054860|Biological|EP HIV-1090|
16381351|NCT00054847|Procedure|saphenous vein graft|Saphenous vein harvested from the arm is used as a conduit for CABG.
16381352|NCT00054847|Procedure|radial artery graft|Radial artery harvested from the arm is used as a conduit for CABG.
16381353|NCT00054834|Drug|hLL2 (epratuzumab)|
16381354|NCT00054821|Procedure|Ankle distraction permitting motion|External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted
16381355|NCT00054821|Procedure|Ankle distraction without motion|External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted
16381356|NCT00054808|Drug|gallium nitrate|
16381357|NCT00054795|Drug|Motexafin Gadolinium|
16381358|NCT00054730|Drug|CX516 (Ampalex®)|
16381359|NCT00054756|Drug|TRH (Thyrotropin Releasing Hormone)|
16381360|NCT00054743|Procedure|Blood draw|
16381361|NCT00054717|Drug|Tipranavir|
16381362|NCT00054717|Drug|Ritonavir(r)|
16381363|NCT00054717|Drug|Comparator Protease Inhibitor (CPI)|
16381364|NCT00054704|Drug|Riluzole|Riluzole
16381365|NCT00054704|Drug|Placebo|Placebo
16381366|NCT00054691|Drug|Iressa|250 mg by mouth daily
16381367|NCT00054678|Drug|MyoCell™|
16381368|NCT00054678|Device|MyoCath™|
16381369|NCT00050531|Drug|Gleevec|400 mg orally twice daily.
16381370|NCT00050531|Drug|Peg-alpha interferon (Peg-Intron)|PEG-IFN 0.5 mcg/kg each week subcutaneously.
16381371|NCT00050531|Drug|Sargramostim (GM-CSF)|125 mcg/m^2 three times per week subcutaneously.
16381372|NCT00054665|Drug|PS-341|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
16381373|NCT00054665|Drug|Etoposide|50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days.
16381374|NCT00054665|Drug|Doxorubicin|10 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
16381375|NCT00054665|Drug|Vincristine|0.4 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
16381376|NCT00054665|Drug|Cyclophosphamide|750 mg/m^2 day IV day 5 bolus. Repeat cycle every 21 days.
16381377|NCT00054665|Drug|Prednisone|60 mg/m^2 by mouth twice a day days 1-5. Repeat cycle every 21 days.
16381378|NCT00054665|Drug|Filgrastim|300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days.
16381379|NCT00054639|Biological|oblimersen sodium|Given IV
16381380|NCT00054639|Biological|rituximab|Given IV
16381381|NCT00054639|Other|laboratory biomarker analysis|Correlative studies
16381382|NCT00054626|Drug|cisplatin|
16381383|NCT00054626|Drug|gemcitabine hydrochloride|
16381384|NCT00054626|Procedure|adjuvant therapy|
16381385|NCT00054613|Drug|Methoxsalen|
16381386|NCT00054613|Procedure|Extracorporeal Photopheresis|
16381387|NCT00054600|Drug|Methoxsalen|
16381388|NCT00054600|Procedure|Extracorporeal Photopheresis|
16381389|NCT00054587|Biological|Trastuzumab|8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
16381390|NCT00054587|Drug|Cyclophosphamide|500 mg/m², D1 and every 3 weeks
16381391|NCT00054587|Drug|docetaxel|on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks
16381392|NCT00054587|Drug|Epirubicin|100 mg/m², D1 and every 3 weeks
16381393|NCT00054587|Drug|Fluorouracil|500 mg/m², D1 and every 3 weeks
16381394|NCT00054574|Biological|panitumumab|
16381395|NCT00054561|Biological|recombinant interferon alfa|
16381396|NCT00054561|Dietary Supplement|vitamin E|
16381397|NCT00054561|Drug|isotretinoin|
16381398|NCT00054561|Procedure|adjuvant therapy|
16381399|NCT00054548|Biological|oblimersen sodium|Given IV
16381400|NCT00054548|Drug|paclitaxel|Given IV
16381401|NCT00054548|Other|laboratory biomarker analysis|Correlative studies
16381402|NCT00054548|Other|pharmacological study|Correlative studies
16381403|NCT00054535|Biological|aldesleukin|
16381404|NCT00054535|Biological|recombinant fowlpox-tyrosinase vaccine|
16381405|NCT00054535|Biological|vaccinia-tyrosinase vaccine|
16381406|NCT00054522|Dietary Supplement|calcitriol|
16381407|NCT00054522|Drug|dexamethasone|
16381408|NCT00054496|Drug|erlotinib hydrochloride|
16381409|NCT00054483|Drug|bortezomib|Given IV
16381410|NCT00054483|Other|laboratory biomarker analysis|Correlative studies
16381411|NCT00054483|Other|pharmacological study|Correlative studies
16381412|NCT00054470|Biological|trastuzumab|
16381413|NCT00054470|Drug|tipifarnib|
16381414|NCT00054457|Drug|capecitabine|
16381415|NCT00054457|Drug|docetaxel|
16381416|NCT00054444|Drug|Topotecan Hydrochloride Liposomes|Given IV
16381417|NCT00054444|Radiation|3-Dimensional Conformal Radiation Therapy|
16381418|NCT00054444|Drug|Cisplatin|Given IV
16381419|NCT00054431|Drug|imatinib mesylate|Given orally
16381420|NCT00054431|Drug|decitabine|Given IV
16381421|NCT00054431|Other|laboratory biomarker analysis|Correlative studies
16381422|NCT00054418|Dietary Supplement|calcium carbonate|calcium 600 mg daily administered orally for one year
16381423|NCT00054418|Dietary Supplement|vitamin D|vitamin D 400 U daily administered orally for one year
16381424|NCT00054418|Drug|risedronate sodium|risedronate 35 mg weekly administered orally
16381425|NCT00054418|Other|placebo|placebo tablet weekly administered orally for one year
16381426|NCT00054405|Biological|recombinant interleukin-12|Given IV
16381427|NCT00054405|Biological|aldesleukin|Given IV
16381428|NCT00054392|Drug|carboplatin|
16381429|NCT00054392|Drug|gemcitabine hydrochloride|
16381430|NCT00054392|Drug|paclitaxel|
16381431|NCT00054353|Drug|fludarabine phosphate|Given IV
16381432|NCT00054353|Drug|melphalan|Given IV
16381433|NCT00054353|Radiation|total-body irradiation|Undergo TBI
16381434|NCT00054353|Drug|mycophenolate mofetil|Given PO
16381435|NCT00054353|Drug|cyclosporine|Given PO
16381436|NCT00054353|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo reduced-intensity allogeneic PBSCT
16381437|NCT00054353|Procedure|peripheral blood stem cell transplantation|Undergo reduced-intensity allogeneic PBSCT
16381438|NCT00054353|Other|laboratory biomarker analysis|Correlative studies
16381439|NCT00054340|Biological|anti-thymocyte globulin|
16381440|NCT00054340|Drug|busulfan|
16381441|NCT00054340|Drug|cyclophosphamide|
16381442|NCT00054340|Drug|cyclosporine|
16381443|NCT00054340|Drug|methotrexate|
16381444|NCT00054340|Procedure|allogeneic bone marrow transplantation|
16381445|NCT00054340|Procedure|peripheral blood stem cell transplantation|
16381446|NCT00054327|Drug|busulfan|Given orally 1mg/kg/dose (or 40mg/m2/dose for young children)
16381447|NCT00054327|Drug|cyclophosphamide|Given IV
16381448|NCT00054327|Drug|cytarabine|Given IV
16381449|NCT00054327|Radiation|radiation therapy|Patients undergo total body irradiation
16381450|NCT00054327|Drug|Etoposide|infusion
16381451|NCT00054327|Procedure|Stem Cell Transfusion|
16381452|NCT00054314|Drug|ortataxel|
16381453|NCT00054301|Procedure|adjuvant therapy|
16381454|NCT00054301|Procedure|conventional surgery|Patients undergo excisional biopsy or surgery.
16381455|NCT00054301|Radiation|intraoperative radiation therapy|Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity.
16381456|NCT00054288|Drug|gemcitabine hydrochloride|
16381457|NCT00054288|Drug|irinotecan hydrochloride|
16381458|NCT00054275|Drug|docetaxel|Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.
16381459|NCT00054275|Drug|erlotinib hydrochloride|OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.
16381460|NCT00054262|Drug|T900607|
16381461|NCT00054249|Drug|T900607|
16381462|NCT00054236|Biological|anti-thymocyte globulin|anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1
16381463|NCT00054236|Biological|filgrastim|Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
16381464|NCT00054236|Drug|cyclophosphamide|cyclophosphamide IV over 2 hours on days -3 to -2
16381465|NCT00054236|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
16381466|NCT00054236|Procedure|umbilical cord blood transplantation|Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.
16381467|NCT00054236|Drug|methylprednisolone|Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
16381468|NCT00054223|Procedure|psychosocial assessment and care|
16381469|NCT00054210|Drug|carboplatin|
16381470|NCT00054210|Drug|paclitaxel|
16381471|NCT00054210|Drug|paclitaxel poliglumex|
16381472|NCT00054197|Drug|gemcitabine hydrochloride|
16381473|NCT00054197|Drug|paclitaxel poliglumex|
16381474|NCT00054197|Drug|vinorelbine tartrate|
16381475|NCT00054184|Drug|docetaxel|
16381476|NCT00054184|Drug|paclitaxel poliglumex|
16381477|NCT00054171|Drug|aminolevulinic acid hydrochloride|
16381479|NCT00054158|Drug|doxorubicin hydrochloride|
16381480|NCT00054158|Drug|thalidomide|
16381481|NCT00054158|Drug|vincristine sulfate|
16381482|NCT00054145|Drug|perifosine|
16381483|NCT00054132|Biological|Bevacizumab|Given IV
16381484|NCT00054132|Drug|Erlotinib Hydrochloride|Given PO
16381485|NCT00054132|Other|Laboratory Biomarker Analysis|Correlative studies
16381486|NCT00054119|Drug|Cositecan|Given IV
16381487|NCT00054119|Other|Pharmacological Study|Correlative studies
16381488|NCT00054106|Drug|buserelin|
16381489|NCT00054106|Drug|custirsen sodium|
16381490|NCT00054106|Drug|flutamide|
16381491|NCT00054106|Procedure|conventional surgery|
16381492|NCT00054106|Procedure|neoadjuvant therapy|
16381493|NCT00054067|Drug|cisplatin|
16381494|NCT00054067|Procedure|adjuvant therapy|
16381495|NCT00054067|Procedure|conventional surgery|
16381496|NCT00054067|Radiation|brachytherapy|
16381497|NCT00054067|Radiation|radiation therapy|
16381498|NCT00054054|Drug|cisplatin|
16381499|NCT00054054|Drug|docetaxel|
16381500|NCT00054054|Drug|fluorouracil|
16381501|NCT00054054|Radiation|radiation therapy|
16381502|NCT00054041|Biological|HspE7|Given subcutaneously
16381503|NCT00054041|Procedure|therapeutic conventional surgery|Undergo large loop excision
16381504|NCT00054041|Other|laboratory biomarker analysis|Correlative studies
16381505|NCT00054028|Drug|suramin|Given IV
16381506|NCT00054028|Drug|paclitaxel|Given IV
16381507|NCT00054028|Other|pharmacological study|Correlative studies
16381508|NCT00054015|Drug|triapine|
16381509|NCT00054002|Procedure|adjuvant therapy|Lung surgery
16381510|NCT00054002|Procedure|conventional surgery|Lung surgery
16381511|NCT00054002|Drug|porfimer sodium|iv
16381512|NCT00053989|Biological|anti-thymocyte globulin|iv
16381513|NCT00053989|Biological|graft-versus-tumor induction therapy|iv
16381514|NCT00053989|Biological|sargramostim|iv
16381515|NCT00053989|Biological|therapeutic allogeneic lymphocytes|iv
16381516|NCT00053989|Drug|cyclophosphamide|injection
16381517|NCT00053989|Drug|fludarabine phosphate|iv
16381518|NCT00053989|Drug|methylprednisolone|oral
16381519|NCT00053989|Drug|mycophenolate mofetil|oral
16381520|NCT00053989|Drug|tacrolimus|oral
16381521|NCT00053989|Procedure|allogeneic bone marrow transplantation|iv
16381522|NCT00053989|Procedure|peripheral blood stem cell transplantation|iv
16381523|NCT00053989|Procedure|umbilical cord blood transplantation|iv
16381524|NCT00053976|Biological|Daclizumab|
16381525|NCT00053976|Drug|methylprednisolone|
16381526|NCT00053976|Drug|Placebo|
16381527|NCT00053963|Drug|romidepsin|Given IV
16381528|NCT00053950|Drug|pyrazoloacridine|Given IV
16381529|NCT00053950|Biological|filgrastim|Given IV or SC
16381530|NCT00053950|Procedure|autologous bone marrow transplantation|Undergo autologous bone marrow transplantation
16381531|NCT00053950|Procedure|peripheral blood stem cell transplantation|Undergo peripheral blood stem cell transplantation
16381532|NCT00053950|Other|laboratory biomarker analysis|Correlative studies
16381533|NCT00053950|Other|pharmacological study|Correlative studies
16381534|NCT00053937|Drug|pirfenidone|
16381535|NCT00053924|Drug|perifosine|
16381536|NCT00053911|Drug|anastrozole|
16381537|NCT00053911|Drug|cyclophosphamide|
16381538|NCT00053911|Drug|docetaxel|
16381539|NCT00053911|Drug|epirubicin hydrochloride|
16381540|NCT00053911|Drug|fluorouracil|
16381541|NCT00053911|Drug|goserelin acetate|
16381542|NCT00053911|Drug|tamoxifen citrate|
16381543|NCT00053911|Procedure|adjuvant therapy|
16381544|NCT00053898|Drug|anastrozole|1 mg/day and placebo for 5 years
16381545|NCT00053898|Drug|tamoxifen citrate|20 mg/day and placebo for 5 years
16381546|NCT00053898|Radiation|Radiation Therapy|Adjuvant radiation therapy
16381547|NCT00053885|Drug|PTK787/ZK 222584|oral
16381548|NCT00053872|Drug|cisplatin|
16381549|NCT00053872|Drug|lomustine|
16381550|NCT00053872|Drug|vincristine sulfate|
16381551|NCT00053872|Procedure|adjuvant therapy|
16381552|NCT00053872|Radiation|radiation therapy|
16381553|NCT00053846|Drug|buspirone hydrochloride|The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
16381554|NCT00053846|Drug|Placebo|Placebo
16381555|NCT00053833|Drug|irinotecan|
16381556|NCT00053820|Biological|aldesleukin|
16381557|NCT00053820|Biological|recombinant interferon alfa|
16381558|NCT00053820|Drug|fluorouracil|
16381559|NCT00053807|Biological|aldesleukin|
16381560|NCT00053807|Biological|recombinant interferon alfa|
16381561|NCT00053807|Drug|fluorouracil|
16381562|NCT00053807|Procedure|adjuvant therapy|
16381563|NCT00053794|Drug|perifosine|
16381564|NCT00053781|Drug|perifosine|
16381565|NCT00053768|Biological|filgrastim|
16381566|NCT00053768|Drug|EPOCH regimen|
16381567|NCT00053768|Drug|cyclophosphamide|
16381568|NCT00053768|Drug|doxorubicin hydrochloride|
16381569|NCT00053768|Drug|etoposide|
16381570|NCT00053768|Drug|prednisone|
16381571|NCT00053768|Drug|vincristine sulfate|
16381572|NCT00053768|Radiation|radiation therapy|
16381573|NCT00053716|Drug|Liprostin [liposomal Prostaglandin E1]|
16381574|NCT00045123|Drug|tarenflurbil|
16381575|NCT00045123|Procedure|adjuvant therapy|
16381576|NCT00028678|Drug|dalteparin|
16381577|NCT00028678|Radiation|radiation therapy|
16381578|NCT00017342|Drug|bryostatin 1|
16381579|NCT00017342|Drug|cytarabine|
16381580|NCT00053742|Drug|Modified Vaccinia Virus Ankara TBC-MVA|
16381581|NCT00053703|Drug|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
16381582|NCT00053703|Drug|Olanzapine (enrollment closed in this treatment)|oral olanzapine 5-20mg per day for up to 52 weeks
16381583|NCT00053703|Drug|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
16381584|NCT00053690|Behavioral|Cognitive Behavior Treatment|
16381585|NCT00053677|Drug|Naltrexone|For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
16381586|NCT00053677|Drug|Placebo|For subjects who were randomly assigned to placebo.
16381587|NCT00053651|Behavioral|Survival Skills for Moms with New Babies|
16381588|NCT00053638|Drug|efavirenz|
16381589|NCT00053638|Drug|tenofovir|
16381590|NCT00053638|Drug|abacavir/lamivudine|
16381591|NCT00053625|Procedure|deep brain stimulation|Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
16381592|NCT00053612|Drug|Vitamin A|
16381593|NCT00053599|Drug|Simvastatin|
16381594|NCT00053573|Biological|Myozyme|20 mg/kg to 40 mg/kg qow
16381595|NCT00053560|Drug|Prasterone (GL701)|
16381596|NCT00053547|Drug|paricalcitol injection|
16381597|NCT00053508|Biological|ACAM1000|Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
16381598|NCT00053508|Biological|vaccinia virus (calf lymph) smallpox vaccine: Dryvax|group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
16381599|NCT00053495|Biological|Vaccinia virus: ACAM2000 smallpox vaccine|Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
16381600|NCT00053495|Biological|vaccinia virus (calf lymph): Dryvax|Group 5 dose: 1.0x10-8th PFU/ml
16381601|NCT00053482|Biological|ACAM2000 Smallpox Vaccine|Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
16381602|NCT00053482|Biological|Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®|Group 5 dose: 1.0x10-8th PFU/ml
16381603|NCT00053443|Device|Medication Reminder System/Adherence Tracker|
16381604|NCT00053430|Drug|Thalidomide|Tablet taken orally daily
16381605|NCT00053430|Drug|Thalidomide placebo|Placebo tablet taken orally daily
16381606|NCT00053417|Drug|Placebo|Placebo for 15 weeks
16381607|NCT00053417|Drug|10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)|"2 week up titration (10 mg)
~12 weeks stable dose (10 mg)
~1 week down titration (10 mg)"
16381608|NCT00053417|Drug|15 mg fampridine-SR (4-aminopyridine, 4-AP)|"10 mg twice daily for 1 week
~15 mg twice daily for 14 weeks
~2 week up titration (10 mg x 1 week, 15 mg x 1 week)
~12 weeks stable dose (15 mg)
~1 week down titration (10 mg)"
16381609|NCT00053417|Drug|20 mg fampridine-SR (4-aminopyridine, 4-AP)|"2 week up titration (10 mg x 1 week, 15 mg x 1 week)
~12 weeks stable dose (20 mg)
~1 week down titration (15 mg x 3 days, 10 mg x 4 days)"
16381610|NCT00053391|Biological|recombinant CD40-ligand|
16381611|NCT00053391|Biological|therapeutic autologous dendritic cells|
16381612|NCT00053378|Drug|paricalcitol injection (Zemplar)|
16381613|NCT00053378|Behavioral|Effects on calcium regulation|
16381614|NCT00053378|Behavioral|Administration of elemental Ca during hypocalcemic ICU pts.|
16381615|NCT00053365|Drug|irofulven|Given IV
16381616|NCT00053352|Procedure|conventional surgery|
16381617|NCT00053352|Drug|cisplatin|Given IV
16381618|NCT00053352|Drug|etoposide|Given IV
16381619|NCT00053352|Biological|bleomycin sulfate|Given IV
16381620|NCT00053352|Other|laboratory biomarker analysis|Correlative studies
16381621|NCT00053339|Drug|tamoxifen|
16381622|NCT00053339|Drug|trastuzumab|
16381623|NCT00053326|Drug|fenretinide|Given orally
16381624|NCT00053326|Other|pharmacological study|Optional correlative studies
16381625|NCT00053300|Drug|thalidomide|oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
16381626|NCT00053300|Procedure|adjuvant therapy|Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
16381627|NCT00053287|Drug|carboplatin|Carboplatin IV over 24 hours on days 1-5
16381628|NCT00053287|Drug|fludarabine phosphate|Fludarabine IV over 5-10 minutes on days 1-5.
16381629|NCT00053287|Drug|thalidomide|Oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.
16381630|NCT00053287|Drug|topotecan hydrochloride|Topotecan IV continuously over 72 hours.
16381631|NCT00053261|Procedure|management of therapy complications|
16381632|NCT00053248|Drug|arsenic trioxide|
16381633|NCT00053248|Drug|imatinib mesylate|
16381634|NCT00053235|Genetic|Comparative Genomic Hybridization|Correlative studies
16381635|NCT00053235|Other|Laboratory Biomarker Analysis|Correlative studies
16381636|NCT00053235|Genetic|Polymerase Chain Reaction|Correlative studies
16381637|NCT00053222|Drug|arsenic trioxide|
16381638|NCT00053209|Drug|gemcitabine hydrochloride|
16381639|NCT00053209|Drug|pemetrexed disodium|
16381640|NCT00053196|Biological|anti-thymocyte globulin|2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
16381641|NCT00053196|Biological|G-CSF|5 ug/kg/day subQ injection Day 7 until ANC> 1000/uL for 3 consec days
16381642|NCT00053196|Drug|busulfan|0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
16381643|NCT00053196|Drug|fludarabine phosphate|30 mg/sq m/day IVBP over 30 min Days -7 thru -3
16381644|NCT00053196|Drug|methotrexate|5 mg/sq m/day IV infusion Days 1, 3, & 6 for HLA-identical donor transplants and Days 1, 3, 6, & 11 for MUD & 9/10 related donor transplants
16381645|NCT00053196|Drug|mycophenolate mofetil|15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
16381722|NCT00052832|Dietary Supplement|doxercalciferol|
16381723|NCT00052780|Drug|O6-benzylguanine|Given IV
16381646|NCT00053196|Drug|tacrolimus|target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
16381647|NCT00053196|Procedure|allogeneic cell transplantation|2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
16381648|NCT00053196|Drug|allopurinol|300 mg/day PO Days -8 thru -1
16381649|NCT00053183|Procedure|conventional surgery|
16381650|NCT00053183|Radiation|brachytherapy|
16381651|NCT00053183|Radiation|radiation therapy|
16381652|NCT00053157|Biological|sargramostim|
16381653|NCT00053144|Drug|cytarabine|
16381654|NCT00053144|Drug|irinotecan hydrochloride|
16381655|NCT00053131|Biological|filgrastim|
16381656|NCT00053131|Biological|sargramostim|
16381657|NCT00053131|Drug|cytarabine|
16381658|NCT00053131|Drug|mitoxantrone hydrochloride|
16381659|NCT00053118|Biological|filgrastim|IV
16381660|NCT00053118|Drug|carboplatin|IV
16381661|NCT00053118|Drug|etoposide|IV
16381662|NCT00053118|Procedure|bone marrow ablation with stem cell support|IV
16381663|NCT00053118|Procedure|peripheral blood stem cell transplantation|IV
16381664|NCT00053105|Drug|cisplatin|
16381665|NCT00053105|Drug|cytarabine|
16381666|NCT00053105|Drug|methylprednisolone|
16381667|NCT00053105|Drug|pixantrone dimaleate|
16381668|NCT00053092|Biological|rituximab|
16381669|NCT00053092|Drug|cyclophosphamide|
16381670|NCT00053092|Drug|fludarabine phosphate|
16381671|NCT00053053|Dietary Supplement|Juven|
16381672|NCT00053053|Dietary Supplement|Non-Juven Supplement|
16381673|NCT00053040|Biological|cintredekin besudotox|IL13-PE38QQR is administered intracerebrally by continuous convection enhanced infusion at a starting concentration of 0.25 μg/mL. Infusion duration will be held constant at 96 hours (4 days). The phase I component of this study is to estimate the maximum safe total flow rate and the maximum safe infusion concentration.
16381674|NCT00053040|Procedure|conventional surgery|Conventional surgery is used for tumor resection prior to catheter placement for IL13-PE38QQR infusion.
16381675|NCT00053027|Biological|rituximab|
16381676|NCT00053027|Drug|cladribine|
16381677|NCT00053014|Biological|therapeutic allogeneic lymphocytes|
16381678|NCT00053014|Drug|cyclosporine|
16381679|NCT00053014|Drug|fludarabine|
16381680|NCT00053014|Drug|mycophenolate mofetil|
16381681|NCT00053014|Procedure|peripheral blood stem cell transplantation|
16381682|NCT00053014|Radiation|radiation therapy|
16381683|NCT00053001|Biological|epoetin alfa|
16381684|NCT00053001|Drug|thalidomide|
16381685|NCT00041275|Drug|megestrol acetate|
16381686|NCT00004078|Drug|irinotecan hydrochloride|Given IV
16381687|NCT00003830|Procedure|conventional surgery|Sentinel node resection immediately followed by axillary dissection.
16381688|NCT00003830|Procedure|Sentinel node resection followed by node examination|Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
16381689|NCT00052962|Procedure|Cytoreductive surgery|"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."
16381690|NCT00052962|Procedure|Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)|"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
~Followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin. Post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluororacil (5-FU) 800 mg/m^2 and paclitaxel 125 mg/m^2.
~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."
16381691|NCT00052949|Drug|imatinib mesylate|Given orally
16381692|NCT00052949|Other|laboratory biomarker analysis|Correlative studies
16381693|NCT00052936|Biological|filgrastim|
16381694|NCT00052936|Biological|rituximab|
16381695|NCT00052936|Drug|CHOP regimen|
16381696|NCT00052936|Drug|cyclophosphamide|
16381697|NCT00052936|Drug|doxorubicin hydrochloride|
16381698|NCT00052936|Drug|prednisone|
16381699|NCT00052936|Drug|vincristine sulfate|
16381700|NCT00052936|Radiation|radiation therapy|36Gy on BULK and extranodal involvement
16381701|NCT00052923|Biological|filgrastim|
16381702|NCT00052923|Biological|rituximab|
16381703|NCT00052923|Drug|carmustine|
16381704|NCT00052923|Drug|cyclophosphamide|
16381705|NCT00052923|Drug|etoposide|
16381706|NCT00052923|Procedure|peripheral blood stem cell transplantation|
16381707|NCT00052923|Radiation|radiation therapy|
16381708|NCT00052910|Drug|cisplatin|Given IV
16381709|NCT00052910|Drug|epirubicin hydrochloride|Given IV
16381710|NCT00052910|Drug|fluorouracil|Given IV
16381711|NCT00052910|Drug|leucovorin calcium|Given IV
16381712|NCT00052910|Radiation|radiation therapy|Given 5 days a week for 5 weeks
16381713|NCT00052897|Biological|HspE7|
16381714|NCT00052884|Biological|filgrastim|
16381715|NCT00052884|Drug|amifostine trihydrate|
16381716|NCT00052884|Drug|melphalan|
16381717|NCT00052884|Procedure|bone marrow ablation with stem cell support|
16381718|NCT00052884|Procedure|peripheral blood stem cell transplantation|
16381719|NCT00052845|Drug|docetaxel|70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle
16381720|NCT00052845|Drug|estramustine phosphate sodium|280 mg PO tid Days 1-5 of ea cycle
16381721|NCT00052845|Drug|exisulind|Two 125 mg capsules PO bid Days 1-21 of ea cycle
16381724|NCT00052780|Drug|temozolomide|Given PO
16381725|NCT00052780|Biological|filgrastim|Given SC or IV
16381726|NCT00052780|Other|pharmacological study|Correlative studies
16381727|NCT00052780|Other|laboratory biomarker analysis|Correlative studies
16381728|NCT00052754|Drug|gefitinib|
16381729|NCT00052728|Drug|tamoxifen citrate|
16381730|NCT00052728|Drug|tipifarnib|
16381731|NCT00052715|Drug|poly ICLC|
16381732|NCT00052689|Drug|bortezomib|Given IV
16381733|NCT00052689|Drug|gemcitabine hydrochloride|Given IV
16381734|NCT00052676|Drug|patent blue V dye|
16381735|NCT00052676|Procedure|radionuclide imaging|
16381736|NCT00052676|Procedure|sentinel lymph node biopsy|
16381737|NCT00052676|Radiation|technetium Tc 99m sulfur colloid|
16381738|NCT00052637|Drug|hexaminolevulinate|
16381739|NCT00052637|Procedure|biopsy|
16381740|NCT00052637|Procedure|cystoscopy|
16381741|NCT00052624|Biological|transferrin-CRM107|
16381742|NCT00052611|Drug|Celecoxib|
16381743|NCT00052598|Biological|therapeutic allogeneic lymphocytes|Given IV
16381744|NCT00052598|Biological|aldesleukin|Given SC
16381745|NCT00052598|Other|laboratory biomarker analysis|Correlative studies
16381746|NCT00052598|Other|flow cytometry|Correlative studies
16381747|NCT00052585|Drug|irinotecan hydrochloride|Given IV
16381748|NCT00052585|Drug|gefitinib|Given orally
16381749|NCT00052585|Drug|leucovorin calcium|Given IV
16381750|NCT00052585|Drug|fluorouracil|Given IV
16381751|NCT00052572|Drug|ixabepilone|
16381752|NCT00052559|Biological|bevacizumab|Given IV
16381753|NCT00052559|Drug|fluorouracil|Given IV
16381754|NCT00052559|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
16381755|NCT00052559|Procedure|therapeutic conventional surgery|Undergo surgery
16381756|NCT00052559|Other|laboratory biomarker analysis|Correlative studies
16381757|NCT00052520|Biological|therapeutic allogeneic lymphocytes|Given IV
16381758|NCT00052520|Biological|aldesleukin|Given SC
16381759|NCT00052520|Procedure|peripheral blood stem cell transplantation|Undergo transplantation
16381760|NCT00052520|Procedure|allogeneic bone marrow transplantation|Undergo transplantation
16381761|NCT00052520|Other|laboratory biomarker analysis|Correlative studies
16381762|NCT00052520|Genetic|gene expression analysis|Correlative studies
16381763|NCT00052520|Other|immunologic technique|Correlative studies
16381764|NCT00052520|Other|flow cytometry|Correlative studies
16381765|NCT00052520|Genetic|polymerase chain reaction|Correlative studies
16381766|NCT00052520|Genetic|cytogenetic analysis|Correlative studies
16381767|NCT00052520|Other|staining method|Correlative studies
16381768|NCT00052507|Drug|bortezomib|
16381769|NCT00052494|Drug|cisplatin|
16381770|NCT00052494|Drug|imatinib mesylate|
16381771|NCT00052494|Drug|irinotecan hydrochloride|
16381772|NCT00052481|Procedure|quality-of-life assessment|
16381773|NCT00052468|Drug|TCG|
16381774|NCT00052468|Drug|TC|
16381775|NCT00052455|Drug|lomustine|
16381776|NCT00052455|Drug|procarbazine hydrochloride|
16381777|NCT00052455|Drug|temozolomide|
16381778|NCT00052455|Drug|vincristine sulfate|
16381779|NCT00052442|Drug|pralatrexate|
16381780|NCT00052429|Drug|cisplatin|
16381781|NCT00052429|Drug|fluorouracil|
16381782|NCT00052429|Procedure|adjuvant therapy|
16381783|NCT00052429|Radiation|radiation therapy|
16381784|NCT00052416|Drug|thalidomide|
16381785|NCT00052403|Drug|monoclonal antibody anti-anb3 integrin|
16381786|NCT00052403|Procedure|anti-cytokine therapy|
16381787|NCT00052403|Procedure|antiangiogenesis therapy|
16381788|NCT00052403|Procedure|antibody therapy|
16381789|NCT00052403|Procedure|biological response modifier therapy|
16381790|NCT00052403|Procedure|growth factor antagonist therapy|
16381791|NCT00052403|Procedure|monoclonal antibody therapy|
16381792|NCT00052390|Biological|bevacizumab|
16381793|NCT00052390|Drug|doxorubicin hydrochloride|
16381794|NCT00052377|Biological|aldesleukin|Given SC
16381795|NCT00052377|Biological|recombinant interleukin-12|Given SC
16381796|NCT00052377|Other|laboratory biomarker analysis|Correlative studies
16381797|NCT00052364|Drug|oxaliplatin|Given IV
16381798|NCT00052364|Other|laboratory biomarker analysis|Correlative studies
16381799|NCT00052351|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|
16381800|NCT00052351|Biological|recombinant vaccinia-CEA(6D)-TRICOM vaccine|
16381801|NCT00052351|Biological|sargramostim|
16381802|NCT00052351|Drug|cyclophosphamide|
16381803|NCT00052351|Drug|doxorubicin hydrochloride|
16381804|NCT00052351|Drug|paclitaxel|
16381805|NCT00052351|Radiation|radiation therapy|
16381806|NCT00052338|Drug|gemcitabine hydrochloride|Given IV
16381807|NCT00052338|Drug|carboplatin|Given IV
16381808|NCT00052338|Drug|bortezomib|Given IV
16381809|NCT00052338|Other|laboratory biomarker analysis|Correlative studies
16381810|NCT00052325|Dietary Supplement|mistletoe extract|
16381811|NCT00052312|Drug|cisplatin|
16381812|NCT00052312|Drug|doxorubicin hydrochloride|
16381813|NCT00052312|Drug|paclitaxel|
16381814|NCT00052299|Drug|cytarabine|
16381815|NCT00052299|Drug|etoposide|
16381816|NCT00052299|Drug|gemtuzumab ozogamicin|
16381817|NCT00052299|Drug|idarubicin|
16381818|NCT00052299|Drug|mitoxantrone hydrochloride|
16381819|NCT00052286|Drug|modafinil|
16381820|NCT00052273|Drug|capecitabine|
16381821|NCT00052273|Drug|enzastaurin hydrochloride|
16381822|NCT00052221|Biological|Epoetin alfa|
16381823|NCT00052221|Other|Placebo|
16381824|NCT00052208|Drug|gefitinib|Given PO
16381825|NCT00052208|Radiation|radiation therapy|Undergo radiation therapy
16381826|NCT00052208|Other|laboratory biomarker analysis|Correlative studies
16381827|NCT00052195|Biological|SRL-172|5 doses of 0.1mL vaccine or placebo given intradermally over 12-months
16381828|NCT00052182|Biological|EP HIV-1090|
16381829|NCT00052169|Drug|ZD1839 in combination with docetaxel|Docetaxel given as 75 mg/m2 IV every 3 weeks combined with ZD1839 (IRESSA) 250 mg orally daily until disease progression or withdrawal criteria are met.
16381830|NCT00049712|Biological|etaracizumab|
16381831|NCT00049699|Drug|laromustine|
16381832|NCT00049686|Drug|laromustine|
16381833|NCT00049673|Drug|prednisone|Given orally
16381834|NCT00049673|Drug|thalidomide|Given orally
16381835|NCT00049660|Drug|capecitabine|
16381836|NCT00049660|Drug|vinorelbine tartrate|
16381837|NCT00049634|Drug|busulfan|
16381838|NCT00049634|Drug|cyclophosphamide|
16381839|NCT00049634|Drug|cyclosporine|
16381840|NCT00049634|Drug|methotrexate|
16381841|NCT00049634|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16381842|NCT00049608|Dietary Supplement|mistletoe extract|
16381843|NCT00049608|Drug|gemcitabine hydrochloride|
16381844|NCT00049595|Biological|bleomycin sulfate|
16381845|NCT00049595|Biological|filgrastim|
16381846|NCT00049595|Biological|pegfilgrastim|
16381847|NCT00049595|Drug|ABVD regimen|
16381848|NCT00049595|Drug|BEACOPP regimen|
16381849|NCT00049595|Drug|cyclophosphamide|
16381850|NCT00049595|Drug|dacarbazine|
16381851|NCT00049595|Drug|doxorubicin hydrochloride|
16381852|NCT00049595|Drug|etoposide|
16381853|NCT00049595|Drug|prednisone|
16381854|NCT00049595|Drug|procarbazine hydrochloride|
16381855|NCT00049595|Drug|vinblastine sulfate|
16381856|NCT00049595|Drug|vincristine sulfate|
16381857|NCT00049582|Drug|decitabine|Given IV
16381858|NCT00049582|Other|laboratory biomarker analysis|Correlative studies
16381859|NCT00049582|Other|pharmacological study|Correlative studies
16381860|NCT00049569|Drug|cytarabine|Given IT
16381861|NCT00049569|Drug|methotrexate|Given IT
16381862|NCT00049569|Drug|vincristine sulfate|Given IV
16381863|NCT00049569|Drug|prednisone|Given PO
16381864|NCT00049569|Drug|pegaspargase|Given IM
16381865|NCT00049569|Drug|doxorubicin hydrochloride|Given IV
16381866|NCT00049569|Drug|imatinib mesylate|Given PO
16381867|NCT00049569|Drug|cyclophosphamide|Given IV
16381868|NCT00049569|Drug|etoposide|Given IV
16381869|NCT00049569|Biological|filgrastim|Given SC
16381870|NCT00049569|Drug|leucovorin calcium|Given IV
16381871|NCT00049569|Drug|asparaginase|Given IM
16381872|NCT00049569|Drug|therapeutic hydrocortisone|Given IT
16381873|NCT00049556|Drug|gefitinib|
16381874|NCT00049556|Other|immunohistochemistry staining method|
16381875|NCT00049556|Other|surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
16381876|NCT00049556|Procedure|biopsy|
16381877|NCT00049556|Procedure|sentinel lymph node biopsy|
16381878|NCT00049543|Drug|gefitinib|Given PO
16381879|NCT00049543|Other|placebo|Given PO
16381880|NCT00049543|Other|laboratory biomarker analysis|Correlative studies
16381881|NCT00049530|Biological|PEG-interferon alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
16381882|NCT00049517|Biological|sargramostim|Given IV or as an injection
16381883|NCT00049517|Drug|busulfan|Given IV
16381884|NCT00049517|Drug|cyclophosphamide|Given IV
16381885|NCT00049517|Drug|cytarabine|Given as a continuous infusion
16381886|NCT00049517|Drug|gemtuzumab ozogamicin (GO)|Given IV
16381887|NCT00049517|Drug|Daunorubicin|Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
16381888|NCT00049517|Procedure|Autologous HCT|Autologous hematopoietic cell transplantation
16381889|NCT00049517|Procedure|Allogeneic HCT|Allogeneic hematopoietic cell transplantation
16381890|NCT00049504|Drug|cyclophosphamide|Given IV
16381891|NCT00049504|Drug|fludarabine phosphate|Given IV
16381892|NCT00049504|Drug|tacrolimus|Given IV or orally
16381893|NCT00049504|Drug|mycophenolate mofetil|Given orally
16381894|NCT00049504|Genetic|polymerase chain reaction|Correlative studies
16381895|NCT00049504|Genetic|fluorescence in situ hybridization|Correlative studies
16381896|NCT00049504|Genetic|polymorphism analysis|Correlative studies
16381897|NCT00049504|Genetic|gene expression analysis|Correlative studies
16381898|NCT00049504|Radiation|total-body irradiation|Undergo total-body irradiation
16381899|NCT00049504|Procedure|allogeneic bone marrow transplantation|Undergo haploidentical hematopoietic bone marrow transplantation
16381900|NCT00049504|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo haploidentical hematopoietic bone marrow transplantation
16381901|NCT00049465|Procedure|fatigue assessment and management|
16381902|NCT00049465|Procedure|management of therapy complications|
16381903|NCT00049465|Procedure|psychosocial assessment and care|
16381904|NCT00049452|Drug|zoledronic acid|
16381905|NCT00049439|Biological|filgrastim|filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
16381906|NCT00049439|Drug|cyclophosphamide|Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
16381907|NCT00049439|Drug|etoposide|Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
16381994|NCT00049036|Other|laboratory biomarker analysis|Correlative studies
16381995|NCT00049023|Radiation|90Y-DOTA-tyr3-OCTREOTIDE|
16381908|NCT00049439|Drug|lomustine|Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
16381909|NCT00049439|Drug|procarbazine hydrochloride|Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
16381910|NCT00049413|Biological|rituximab|
16381911|NCT00049413|Drug|cyclophosphamide|
16381912|NCT00049413|Drug|pentostatin|
16381913|NCT00049400|Drug|BMS-247550|BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
16381914|NCT00049387|Drug|tipifarnib|Given PO
16381915|NCT00049387|Drug|temozolomide|Given PO
16381916|NCT00049387|Radiation|radiation therapy|Undergo partial brain radiation therapy
16381917|NCT00049374|Biological|oblimersen sodium|
16381918|NCT00049374|Drug|dexamethasone|
16381919|NCT00049374|Drug|thalidomide|
16381920|NCT00049361|Drug|temozolomide|
16381921|NCT00049361|Drug|thalidomide|
16381922|NCT00049361|Radiation|radiation therapy|
16381923|NCT00049348|Biological|epoetin alfa|
16381924|NCT00049348|Biological|filgrastim|
16381925|NCT00049348|Drug|cisplatin|
16381926|NCT00049348|Drug|fluorouracil|
16381927|NCT00049348|Drug|gemcitabine hydrochloride|
16381928|NCT00049348|Procedure|adjuvant therapy|
16381929|NCT00049348|Procedure|conventional surgery|
16381930|NCT00049348|Procedure|neoadjuvant therapy|
16381931|NCT00049348|Radiation|radiation therapy|
16381932|NCT00049335|Drug|capecitabine|1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle
16381933|NCT00049322|Biological|bevacizumab|"Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
16381934|NCT00049309|Dietary Supplement|dietary intervention|
16381935|NCT00049309|Dietary Supplement|flaxseed|
16381936|NCT00049296|Drug|docetaxel|"Patients receive docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined."
16381937|NCT00049296|Drug|thalidomide|"Patients receive oral thalidomide twice daily. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
~Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined."
16381938|NCT00049283|Drug|erlotinib hydrochloride|Given orally
16381939|NCT00049283|Drug|docetaxel|Given IV
16381940|NCT00049283|Radiation|radiation therapy|Undergo radiotherapy
16381941|NCT00049283|Procedure|therapeutic conventional surgery|Undergo neck dissection
16381942|NCT00049283|Other|laboratory biomarker analysis|Correlative studies
16381943|NCT00049283|Other|pharmacological study|Correlative studies
16381944|NCT00049257|Drug|carboplatin|Administered Day 1 of each cycle. AUC=6.
16381945|NCT00049257|Drug|paclitaxel|administered Days 1, 8, and 15 of each cycle. 100mg/m2
16381946|NCT00049244|Drug|capecitabine|
16381947|NCT00049244|Drug|ixabepilone|
16381948|NCT00049231|Drug|EF5|
16381949|NCT00049231|Other|immunohistochemistry staining method|
16381950|NCT00049231|Procedure|biopsy|
16381951|NCT00049218|Biological|Autologous dendritic cell-adenovirus p53 vaccine|
16381952|NCT00049218|Drug|Carboplatin|
16381953|NCT00049218|Drug|Etoposide|
16381954|NCT00049192|Biological|oblimersen sodium|Given IV
16381955|NCT00049192|Drug|imatinib mesylate|Given PO
16381956|NCT00049192|Other|laboratory biomarker analysis|Correlative studies
16381957|NCT00049179|Drug|cytarabine|ind and consol: 200 mg/m2/d continuous IV days 1-7
16381958|NCT00049179|Drug|gemtuzumab ozogamicin|ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8
16381959|NCT00049166|Drug|erlotinib hydrochloride|Given orally
16381960|NCT00049166|Drug|cisplatin|Given IV
16381961|NCT00049166|Radiation|intensity-modulated radiation therapy|Undergo intensity modulated radiation therapy
16381962|NCT00049166|Other|laboratory biomarker analysis|Correlative studies
16381963|NCT00049140|Drug|EF5|
16381964|NCT00049140|Other|bioluminescence|
16381965|NCT00049140|Other|flow cytometry|
16381966|NCT00049140|Other|immunohistochemistry staining method|
16381967|NCT00049140|Procedure|biopsy|
16381968|NCT00049127|Drug|Imatinib Mesylate|Given PO
16381969|NCT00049127|Other|Laboratory Biomarker Analysis|Optional correlative studies
16381970|NCT00049127|Other|Pharmacological Study|Optional correlative studies
16381971|NCT00049114|Drug|doxorubicin hydrochloride|
16381972|NCT00049114|Drug|cyclophosphamide|Given IV
16381973|NCT00049114|Drug|tipifarnib|Given orally
16381974|NCT00049114|Biological|filgrastim|Given subcutaneously
16381975|NCT00049114|Procedure|therapeutic conventional surgery|Undergo complete resection
16381976|NCT00049114|Other|laboratory biomarker analysis|Correlative studies
16381977|NCT00049101|Drug|erlotinib hydrochloride|
16381978|NCT00049101|Drug|fluorouracil|
16381979|NCT00049101|Drug|leucovorin calcium|
16381980|NCT00049101|Drug|oxaliplatin|
16381981|NCT00049088|Drug|docetaxel|Given IV
16381982|NCT00049088|Biological|bevacizumab|Given IV
16381983|NCT00049088|Other|laboratory biomarker analysis|Correlative studies
16381984|NCT00049088|Other|pharmacological study|Correlative studies
16381985|NCT00049075|Drug|fludarabine phosphate|
16381986|NCT00049062|Drug|anastrozole|
16381987|NCT00049062|Drug|gefitinib|
16381988|NCT00049036|Biological|rituximab|Given IV
16381989|NCT00049036|Drug|etoposide|Given IV
16381990|NCT00049036|Drug|doxorubicin hydrochloride|Given IV
16381991|NCT00049036|Drug|vincristine sulfate|Given IV
16381992|NCT00049036|Drug|prednisone|Given orally
16381993|NCT00049036|Drug|cyclophosphamide|Given IV
16381996|NCT00049010|Genetic|comparative genomic hybridization|
16381997|NCT00049010|Genetic|cytogenetic analysis|
16381998|NCT00049010|Genetic|fluorescence in situ hybridization|
16381999|NCT00049010|Other|immunohistochemistry staining method|
16382000|NCT00048997|Radiation|Radiation therapy|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
16382001|NCT00048997|Other|Observation|
16382002|NCT00048984|Other|laboratory biomarker analysis|Correlative studies
16382003|NCT00048971|Genetic|mutation analysis|
16382004|NCT00048971|Genetic|polymorphic microsatellite marker analysis|
16382005|NCT00048958|Genetic|cytogenetic analysis|
16382006|NCT00047385|Device|low-dose helical computed tomography|A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.
16382007|NCT00047385|Device|chest radiography|The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
16382008|NCT00047346|Drug|erlotinib hydrochloride|Given PO
16382009|NCT00047346|Other|pharmacological study|Correlative studies
16382010|NCT00047346|Other|laboratory biomarker analysis|Correlative studies
16382011|NCT00047333|Drug|erlotinib hydrochloride|Given PO
16382012|NCT00047333|Other|laboratory biomarker analysis|Correlative studies
16382013|NCT00047333|Other|pharmacological study|Correlative studies
16382014|NCT00047320|Drug|carboplatin|Given IV
16382015|NCT00047320|Drug|etoposide|Given IV
16382016|NCT00047320|Drug|ifosfamide|Given IV
16382017|NCT00047320|Drug|thiotepa|Given IV
16382018|NCT00047320|Procedure|adjuvant therapy|
16382019|NCT00047320|Procedure|conventional surgery|
16382020|NCT00047320|Procedure|neoadjuvant therapy|
16382021|NCT00047320|Procedure|peripheral blood stem cell transplantation|
16382022|NCT00047320|Radiation|radiation therapy|craniospinal irradiation
16382023|NCT00047307|Drug|alvocidib|Given IV
16382024|NCT00047307|Drug|gemcitabine hydrochloride|Given IV
16382025|NCT00047307|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
16382026|NCT00047307|Other|laboratory biomarker analysis|Correlative studies
16382027|NCT00047294|Drug|celecoxib|
16382028|NCT00047294|Drug|temozolomide|
16382029|NCT00047294|Drug|thalidomide|
16382030|NCT00047294|Procedure|adjuvant therapy|
16382031|NCT00047281|Drug|celecoxib|
16382032|NCT00047281|Drug|cyclophosphamide|
16382033|NCT00047281|Drug|etoposide|
16382034|NCT00047281|Drug|thalidomide|
16382035|NCT00047268|Drug|cytarabine|
16382036|NCT00047268|Drug|mercaptopurine|
16382037|NCT00047268|Other|laboratory biomarker analysis|
16382038|NCT00047268|Procedure|allogeneic bone marrow transplantation|
16382039|NCT00047268|Procedure|biopsy|
16382040|NCT00047268|Procedure|peripheral blood stem cell transplantation|
16382041|NCT00047255|Biological|trastuzumab|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
16382042|NCT00047255|Drug|carboplatin|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
16382043|NCT00047255|Drug|docetaxel|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose administered by IV infusion over 90 minutes, Day 2: Docetaxel (T) 100 mg/m2 by IV infusion over 30 minutes, Day 8: (H) 2mg/kg administered by IV infusion over 30 minutes, Day 15: 2mg/kg administered by IV infusion over 30 minutes.
~Subsequent cycles: Day 1: (T) 100mg/m2 as 1 hour IV infusion given every 3 weeks, followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes.
~Last cycle: Day 1: (T) 100mg/m2 as 1 hour IV infusion followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 22: (H) 6 mg/kg administered by IV infusion over 30 minutes."
16382044|NCT00047255|Biological|trastuxumab|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose administered by IV infusion over 90 minutes, Day 2: Docetaxel (T) 100 mg/m2 by IV infusion over 30 minutes, Day 8: (H) 2mg/kg administered by IV infusion over 30 minutes, Day 15: 2mg/kg administered by IV infusion over 30 minutes.
~Subsequent cycles: Day 1: (T) 100mg/m2 as 1 hour IV infusion given every 3 weeks, followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes.
~Last cycle: Day 1: (T) 100mg/m2 as 1 hour IV infusion followed by (H) 2 mg/kg IV infusion over 30 minutes, Day 8: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 15: (H) 2 mg/kg administered by IV infusion over 30 minutes, Day 22: (H) 6 mg/kg administered by IV infusion over 30 minutes."
16382101|NCT00046995|Drug|carboplatin|
16382102|NCT00046995|Drug|fluorouracil|
16382103|NCT00046995|Drug|leucovorin calcium|
16382104|NCT00046995|Procedure|adjuvant therapy|
16382105|NCT00046969|Biological|epoetin beta|
16382045|NCT00047255|Drug|Docetaxel|"Cycle 1: Day 1: Herceptin (H) 4 mg/kg loading dose admin by IV over 90 mins, Day 2: Docetaxel (T) 75 mg/m2 by IV over 1 hour followed by carboplatin (C) at target AUC=6 mg/mL/min admin by IV over 30-60 mins, Day 8: (H) 2mg/kg admin by IV over 30 mins, Day 15: 2mg/kg admin by IV over 30 mins.
~Subsequent cycles: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins.
~Last cycle: Day 1: (T) 75mg/m2 as 1 hour IV followed by (C) at target AUC=6 mg/mL/min admin by IV 30-60 mins every 3 weeks followed by (H) 2 mg/kg IV over 30 mins, Day 8: (H) 2 mg/kg admin by IV over 30 mins, Day 15: (H) 2 mg/kg admin by IV over 30 mins, Day 22: (H) 6 mg/kg admin by IV over 30 mins."
16382046|NCT00047242|Drug|7-hydroxystaurosporine|
16382047|NCT00047242|Drug|irinotecan hydrochloride|
16382048|NCT00047229|Biological|oblimersen sodium|
16382049|NCT00047229|Drug|doxorubicin hydrochloride|
16382050|NCT00047216|Drug|tipifarnib|
16382051|NCT00047203|Drug|alvocidib|Given IV
16382052|NCT00047190|Drug|tipifarnib|Given PO
16382053|NCT00047190|Other|laboratory biomarker analysis|Correlative studies
16382054|NCT00047177|Drug|Oxaliplatin|
16382055|NCT00047164|Biological|ipilimumab|
16382056|NCT00047138|Biological|dactinomycin|
16382057|NCT00047138|Drug|carboplatin|
16382058|NCT00047138|Drug|cyclophosphamide|
16382059|NCT00047138|Drug|doxorubicin hydrochloride|
16382060|NCT00047138|Drug|etoposide|
16382061|NCT00047138|Drug|vincristine sulfate|
16382062|NCT00047138|Procedure|adjuvant therapy|
16382063|NCT00047138|Procedure|conventional surgery|
16382064|NCT00047138|Procedure|neoadjuvant therapy|
16382065|NCT00047138|Radiation|radiation therapy|
16382066|NCT00047125|Radiation|radiation therapy|
16382067|NCT00047112|Drug|cisplatin|
16382068|NCT00047112|Drug|fluorouracil|
16382069|NCT00047112|Procedure|conventional surgery|
16382070|NCT00047112|Procedure|neoadjuvant therapy|
16382071|NCT00047112|Radiation|radiation therapy|
16382072|NCT00047099|Drug|cyclophosphamide|
16382073|NCT00047099|Drug|docetaxel|
16382074|NCT00047099|Drug|epirubicin hydrochloride|
16382075|NCT00047099|Drug|fluorouracil|
16382076|NCT00047099|Drug|goserelin acetate|
16382077|NCT00047099|Drug|tamoxifen citrate|
16382078|NCT00047099|Procedure|adjuvant therapy|
16382079|NCT00047099|Radiation|radiation therapy|
16382080|NCT00047073|Drug|Rapamycin|"Phase 1: Initial dose 6mg on day 1 and then 2mg each day for 5-7 days before surgery. No dosing during surgery recovery. After recorvery 6mg loading dose on day 1 then 2mg each day. Cycle is every 4 weeks.
~Dose escalation: Level 2: 15mg load/5mg/day, Level 3: 30mg load/10mg/day, Level 4: 45mg load/15mg/day.
~Phase 2: Will utilize dose established in phase I. Dosing schedule will remain the same."
16382081|NCT00047073|Procedure|Surgery|Surgical resection.
16382082|NCT00047073|Procedure|Supportive Care|"Corticosteroids should be used in smallest dose to control symptoms of cerebral edema and mass effect.
~Anti-seizure medications should be used as indicated. Febrile neutropenia may be managed according to local institution's infectious disease guidelines.
~If neurosurgical management is required for reasons not due to tumor progression, these procedures must be documented."
16382083|NCT00047060|Other|A matched peripheral donor stem cells|A matched peripheral donor stem cells
16382084|NCT00047060|Drug|cyclosporine|cyclosporine
16382085|NCT00047060|Drug|fludarabine|fludarabine
16382086|NCT00047060|Drug|Campath|Campath
16382087|NCT00047047|Drug|gemcitabine hydrochloride|Given IV
16382088|NCT00047047|Drug|tanespimycin|Given IV
16382089|NCT00047047|Drug|cisplatin|Given IV
16382090|NCT00047047|Other|laboratory biomarker analysis|Correlative studies
16382091|NCT00047034|Drug|eribulin mesylate|Given IV
16382092|NCT00047034|Other|pharmacological study|Correlative studies
16382093|NCT00047034|Other|laboratory biomarker analysis|Correlative studies
16382094|NCT00047021|Biological|sargramostim|Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
16382095|NCT00047021|Drug|cytarabine|high-dose cytarabine IV over 1 hour on days 1-5
16382096|NCT00047021|Drug|mitoxantrone hydrochloride|high-dose mitoxantrone IV over 15-30 minutes on day 5.
16382097|NCT00047008|Drug|cisplatin|100 mg/m^2 intravenously on days 1, 22
16382098|NCT00047008|Radiation|Standard fractionation RT|Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.
16382099|NCT00047008|Radiation|Accelerated fractionation radiation therapy|Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.
16382100|NCT00047008|Procedure|Conventional surgery for select patients|"Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer.
~A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made."
16382108|NCT00046969|Radiation|radiation therapy|
16382109|NCT00046943|Drug|atrasentan hydrochloride|
16382110|NCT00046930|Biological|filgrastim|250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to > 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
16382111|NCT00046930|Biological|sargramostim|5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to > 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
16382112|NCT00046930|Drug|cytarabine|100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7).
16382113|NCT00046930|Drug|daunorubicin hydrochloride|45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3).
16382114|NCT00046930|Drug|zosuquidar trihydrochloride|"Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.
~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3."
16382115|NCT00046930|Drug|Placebo|"Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.
~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored."
16382116|NCT00046917|Drug|alvocidib|Given IV
16382117|NCT00046917|Drug|irinotecan hydrochloride|Given IV
16382118|NCT00046917|Drug|cisplatin|Given IV
16382119|NCT00046904|Biological|etanercept|
16382120|NCT00046891|Drug|Ginkgo Biloba|Patients will take 120 mg per day (60 mg BID)
16382121|NCT00046891|Other|Placebo|Patients will take 1 tablet BID
16382122|NCT00046865|Procedure|acupressure therapy|
16382123|NCT00046865|Procedure|management of therapy complications|
16382124|NCT00046865|Procedure|nausea and vomiting therapy|
16382125|NCT00046852|Biological|filgrastim|
16382126|NCT00046852|Biological|pneumococcal polyvalent vaccine|
16382127|NCT00046852|Biological|therapeutic autologous lymphocytes|
16382128|NCT00046852|Biological|therapeutic tumor infiltrating lymphocytes|
16382129|NCT00046852|Drug|carmustine|
16382130|NCT00046852|Drug|cyclophosphamide|
16382131|NCT00046852|Drug|melphalan|
16382132|NCT00046852|Procedure|bone marrow ablation with stem cell support|
16382133|NCT00046852|Procedure|peripheral blood stem cell transplantation|
16382134|NCT00046839|Drug|celecoxib|
16382135|NCT00046839|Radiation|radiation therapy|
16382136|NCT00046826|Drug|docetaxel|
16382137|NCT00046826|Drug|estramustine phosphate sodium|
16382138|NCT00046826|Drug|thalidomide|
16382139|NCT00045747|Drug|7-hydroxystaurosporine|
16382140|NCT00045747|Drug|fluorouracil|
16382141|NCT00045734|Drug|imatinib mesylate|Given orally
16382142|NCT00045734|Other|laboratory biomarker analysis|Correlative studies
16382143|NCT00045734|Other|pharmacological study|Correlative studies
16382144|NCT00045721|Drug|O6-benzylguanine|
16382145|NCT00045721|Drug|polifeprosan 20 with carmustine implant|
16382146|NCT00045721|Procedure|adjuvant therapy|
16382147|NCT00045721|Procedure|conventional surgery|
16382148|NCT00045721|Procedure|neoadjuvant therapy|
16382149|NCT00045708|Drug|ixabepilone|Given IV
16382150|NCT00045708|Other|pharmacological study|Correlative studies
16382151|NCT00045708|Drug|Anticonvulsant|Drugs that induce hepatic Metabolic enzymes
16382152|NCT00045695|Drug|bortezomib|PS-341 bolus intravenous injection twice weekly* for 2 out of every 3 weeks
16382153|NCT00045682|Drug|Paclitaxel Poliglumex|Given IV
16382154|NCT00045669|Drug|imatinib mesylate|
16382155|NCT00045630|Drug|carboplatin|
16382156|NCT00045630|Drug|gemcitabine|
16382157|NCT00045630|Drug|paclitaxel|
16382158|NCT00045630|Procedure|surgery|
16382159|NCT00045617|Biological|monoclonal antibody 11D10 anti-idiotype vaccine|
16382160|NCT00045617|Biological|monoclonal antibody GD2 anti-idiotype vaccine|
16382161|NCT00045617|Drug|cisplatin|
16382162|NCT00045617|Drug|etoposide|
16382163|NCT00045617|Radiation|radiation therapy|
16382164|NCT00045604|Drug|cisplatin|
16382165|NCT00045604|Drug|imatinib mesylate|
16382166|NCT00045604|Drug|irinotecan hydrochloride|
16382167|NCT00045591|Drug|celecoxib|100 mg PO bid
16382168|NCT00045591|Drug|Celecoxib|400 mg PO bid
16382169|NCT00045565|Drug|arsenic trioxide|Given IV
16382170|NCT00045565|Radiation|radiation therapy|Undergo radiation therapy
16382171|NCT00045539|Drug|leucovorin calcium|
16382172|NCT00045539|Drug|methotrexate|
16382173|NCT00045539|Drug|thiotepa|
16382174|NCT00045526|Drug|erlotinib hydrochloride|Given PO
16382175|NCT00045526|Other|laboratory biomarker analysis|Correlative studies
16382176|NCT00045513|Drug|7-hydroxystaurosporine|
16382177|NCT00045513|Drug|fludarabine phosphate|
16382178|NCT00045500|Drug|7-hydroxystaurosporine|
16382179|NCT00045500|Drug|prednisone|
16382180|NCT00045487|Drug|OSI-774|OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
16382181|NCT00045474|Procedure|adjuvant therapy|
16382182|NCT00045474|Radiation|iodine I 125|
16382183|NCT00045461|Drug|carboplatin|
16382184|NCT00045461|Drug|ifosfamide|
16382185|NCT00045461|Procedure|hyperthermia treatment|
16382186|NCT00045448|Drug|alvocidib|
16382187|NCT00045448|Drug|docetaxel|
16382188|NCT00045435|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
16382189|NCT00045435|Drug|fludarabine phosphate|Given IV
16382190|NCT00045435|Radiation|total-body irradiation|Undergo TBI
16382191|NCT00045435|Drug|cyclosporine|Given PO
16382192|NCT00045435|Drug|mycophenolate mofetil|Given PO
16382809|NCT00032175|Drug|capecitabine|
16382193|NCT00045435|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
16382194|NCT00045422|Biological|recombinant interferon alfa|
16382195|NCT00045422|Drug|imatinib mesylate|
16382196|NCT00045396|Drug|tipifarnib|Given orally
16382197|NCT00045370|Biological|recombinant interferon alfa|
16382198|NCT00045370|Drug|temsirolimus|
16382199|NCT00045331|Genetic|proteomic profiling|
16382200|NCT00045318|Drug|exatecan mesylate|
16382201|NCT00045305|Drug|Cyclosporine|Immunosuppressant
16382202|NCT00045305|Drug|Methotrexate|Antimetabolite
16382203|NCT00045305|Drug|Photopheresis|Psoralens
16382204|NCT00045305|Drug|Mycofenolate mofetil|an antibiotic with immunosuppressamt properties isolated from Penicillium spp
16382205|NCT00045305|Drug|Pentostatin|Purine analogue
16382206|NCT00045305|Procedure|allogeneic bone marrow|Unmanipulated allogeneic bone marrow
16382207|NCT00045305|Procedure|peripheral blood stem cell|G-CSF mobilized peripheral blood stem cell
16382208|NCT00045305|Radiation|Total body irradiation|a total of 600 cGy given in 3 200 cGy fractionated doses
16382209|NCT00045292|Drug|acyclovir|
16382210|NCT00045292|Drug|acyclovir sodium|
16382211|NCT00045292|Drug|valacyclovir|
16382212|NCT00045279|Biological|PEG-interferon alfa-2b|
16382213|NCT00045266|Biological|ziv-aflibercept|
16382214|NCT00045227|Biological|recombinant fowlpox-prostate specific antigen vaccine|
16382215|NCT00045227|Biological|recombinant vaccinia prostate-specific antigen vaccine|
16382216|NCT00045227|Biological|recombinant vaccinia-B7.1 vaccine|
16382217|NCT00045227|Biological|sargramostim|
16382218|NCT00045227|Drug|docetaxel|
16382219|NCT00045201|Drug|Erlotinib Hydrochloride|Given orally
16382220|NCT00045201|Drug|Irinotecan Hydrochloride|Given IV
16382221|NCT00045188|Drug|imatinib mesylate|Given PO
16382222|NCT00045188|Other|laboratory biomarker analysis|Optional correlative studies
16382223|NCT00045175|Drug|7-hydroxystaurosporine|
16382224|NCT00045175|Drug|topotecan hydrochloride|
16382225|NCT00045162|Drug|cisplatin|"Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
~Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles"
16382226|NCT00045162|Drug|etoposide|100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
16382227|NCT00045162|Drug|irinotecan hydrochloride|60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles
16382228|NCT00045136|Drug|melphalan|
16382229|NCT00045136|Procedure|peripheral blood stem cell transplantation|
16382230|NCT00045136|Radiation|holmium Ho 166 DOTMP|
16382231|NCT00045110|Drug|erlotinib hydrochloride|given orally
16382232|NCT00045110|Other|laboratory biomarker analysis|correlative studies
16382233|NCT00045110|Other|pharmacological study|correlative studies
16382234|NCT00045097|Drug|ixabepilone|
16382235|NCT00045045|Procedure|positron emission tomography|
16382236|NCT00045045|Radiation|fludeoxyglucose F 18|
16382237|NCT00045032|Drug|Herceptin|Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
16382238|NCT00045032|Drug|Herceptin|Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
16382239|NCT00045019|Other|quality-of-life assessment|QLQ-C30 SAT32
16382240|NCT00045006|Drug|vorinostat|
16382241|NCT00044993|Biological|Ad5CMV-p53 gene|
16382242|NCT00044993|Drug|docetaxel|
16382243|NCT00044993|Drug|doxorubicin hydrochloride|
16382244|NCT00044993|Procedure|conventional surgery|
16382245|NCT00044993|Procedure|neoadjuvant therapy|
16382246|NCT00044980|Procedure|nutritional support|
16382247|NCT00044980|Procedure|quality-of-life assessment|
16382248|NCT00044967|Genetic|microsatellite instability analysis|
16382249|NCT00044954|Biological|therapeutic allogeneic lymphocytes|
16382250|NCT00044954|Drug|cyclosporine|
16382251|NCT00044954|Drug|fludarabine phosphate|
16382252|NCT00044954|Drug|mycophenolate mofetil|
16382253|NCT00044954|Procedure|allogeneic bone marrow transplantation|
16382254|NCT00044954|Procedure|peripheral blood stem cell transplantation|
16382255|NCT00044954|Radiation|radiation therapy|
16382256|NCT00043147|Drug|beclomethasone dipropionate|
16382257|NCT00043147|Drug|methylprednisolone|
16382258|NCT00043147|Drug|prednisone|
16382259|NCT00043134|Drug|decitabine|
16382260|NCT00043121|Drug|oxaliplatin|Given IV
16382261|NCT00043121|Drug|leucovorin calcium|Given IV
16382262|NCT00043121|Drug|fluorouracil|Given IV
16382263|NCT00043121|Drug|capecitabine|Given orally
16382264|NCT00043121|Other|pharmacological study|Correlative studies
16382265|NCT00043095|Drug|gemcitabine hydrochloride|
16382266|NCT00043095|Drug|ixabepilone|
16382267|NCT00043082|Drug|carboplatin|intravenous q 4 weeks
16382268|NCT00043082|Drug|pegylated liposomal doxorubicin hydrochloride|intravenous q 4 weeks
16382269|NCT00043069|Dietary Supplement|calcium carbonate|
16382270|NCT00043069|Dietary Supplement|cholecalciferol|
16382271|NCT00043069|Drug|Estrogen Antagonists|
16382272|NCT00043069|Drug|risedronate sodium|
16382273|NCT00043069|Other|placebo|
16382274|NCT00043043|Drug|celecoxib|
16382275|NCT00043030|Procedure|psychosocial assessment and care|
16382276|NCT00043017|Procedure|MRI/MRS|Serial MRI studies evaluated for prognostic properties related to therapeutic response.
16382277|NCT00043017|Radiation|gadopentetate dimeglumine|Imaging agent used for contrast enhancement in each of the MRIs.
16382278|NCT00043004|Biological|bevacizumab|
16382279|NCT00043004|Drug|FOLFOX regimen|
16382280|NCT00043004|Drug|fluorouracil|
16382281|NCT00043004|Drug|leucovorin calcium|
16382282|NCT00043004|Drug|oxaliplatin|
16382283|NCT00043004|Procedure|conventional surgery|
16382284|NCT00043004|Procedure|radiofrequency ablation|
16382285|NCT00042991|Drug|gefitinib|Given orally
16382286|NCT00042991|Radiation|radiation therapy|Undergo standard brain irradiation
16382287|NCT00042991|Other|pharmacological study|Correlative studies
16382288|NCT00042991|Other|laboratory biomarker analysis|Correlative studies
16382289|NCT00042978|Biological|oblimersen sodium|Given IV
16382290|NCT00042978|Drug|carboplatin|Given IV
16382291|NCT00042978|Drug|etoposide|Given IV
16382292|NCT00042965|Drug|capecitabine|
16382293|NCT00042965|Drug|gemcitabine hydrochloride|
16382294|NCT00042952|Drug|imatinib mesylate|Given orally
16382295|NCT00042952|Procedure|therapeutic conventional surgery|Undergo surgical resection
16382296|NCT00042952|Other|laboratory biomarker analysis|Correlative studies
16382297|NCT00042939|Biological|cetuximab|Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.
16382298|NCT00042939|Drug|docetaxel|Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.
16382299|NCT00042939|Drug|irinotecan hydrochloride|After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.
16382300|NCT00042926|Other|immunohistochemistry staining method|
16382301|NCT00042926|Procedure|conventional surgery|
16382302|NCT00042926|Procedure|lymphangiography|
16382303|NCT00042926|Procedure|radionuclide imaging|
16382304|NCT00042926|Procedure|sentinel lymph node biopsy|
16382305|NCT00042926|Radiation|technetium Tc 99m sulfur colloid|
16382306|NCT00042913|Biological|epratuzumab|
16382307|NCT00042887|Drug|mitomycin C|
16382308|NCT00042887|Procedure|conventional surgery|
16382309|NCT00042874|Drug|alvocidib|Given IV
16382310|NCT00042874|Drug|irinotecan hydrochloride|Given IV
16382311|NCT00042874|Drug|fluorouracil|Given IV
16382312|NCT00042874|Drug|leucovorin calcium|Given IV
16382313|NCT00042874|Other|laboratory biomarker analysis|Correlative studies
16382314|NCT00042861|Drug|7-hydroxystaurosporine|
16382315|NCT00042861|Drug|fluorouracil|
16382316|NCT00042861|Drug|leucovorin calcium|
16382317|NCT00042848|Drug|modafinil|
16382318|NCT00042835|Drug|cisplatin|Given IV
16382319|NCT00042835|Drug|etoposide|Given IV
16382320|NCT00042835|Drug|erlotinib hydrochloride|Given orally
16382321|NCT00042835|Radiation|radiation therapy|Undergo radiotherapy
16382322|NCT00042835|Drug|docetaxel|Given IV
16382323|NCT00042835|Drug|paclitaxel|Given IV
16382324|NCT00042835|Drug|carboplatin|Given IV
16382325|NCT00042835|Other|laboratory biomarker analysis|Correlative studies
16382326|NCT00042822|Drug|romidepsin|
16382327|NCT00042809|Drug|paclitaxel|Given IV
16382328|NCT00042809|Biological|trastuzumab|Given IV
16382329|NCT00042809|Drug|erlotinib hydrochloride|Given orally
16382330|NCT00042809|Other|laboratory biomarker analysis|Correlative studies
16382331|NCT00042809|Other|pharmacological study|Correlative studies
16382332|NCT00042796|Drug|decitabine|Given IV
16382333|NCT00042796|Other|pharmacological study|Correlative studies
16382334|NCT00042796|Other|laboratory biomarker analysis|Correlative studies
16382335|NCT00042783|Biological|D1/3-MAGE-3-His fusion protein|
16382336|NCT00042783|Biological|SB-AS02B adjuvant|
16382337|NCT00042770|Other|talc|Given intrapleurally
16382338|NCT00042770|Procedure|dyspnea management|No talc
16382339|NCT00042731|Dietary Supplement|Lycopene|Daily administration as outlined in treatment arm(s)
16382340|NCT00042731|Dietary Supplement|Multivitamin|Daily administration as outlined in treatment arm(s)
16382341|NCT00042731|Dietary Supplement|Soy isoflavones|Daily administration as outlined in treatment arm(s)
16382342|NCT00041379|Drug|beta alethine|
16382343|NCT00041340|Drug|imatinib mesylate|Given orally
16382344|NCT00041340|Other|laboratory biomarker analysis|Correlative studies
16382345|NCT00041327|Biological|filgrastim|5 ug/kg/d
16382346|NCT00041327|Biological|recombinant interferon alfa|9 mU subcutaneously per day for one year
16382347|NCT00041327|Drug|Etoposide|50 mg/m2/day continuous 96 hr infusion, days 1-4
16382348|NCT00041327|Drug|cyclophosphamide|750 mg/m2 IV on day 5
16382349|NCT00041327|Drug|doxorubicin hydrochloride|10 mg/m2/day as a continuous 96-hour infusion days 1-4
16382350|NCT00041327|Drug|lamivudine|150 mg bid
16382351|NCT00041327|Drug|prednisone|60 mg/m2 given orally days 1-5
16382352|NCT00041327|Drug|vincristine sulfate|0.4 mg/m2/day as a 96-hour continuous infusion days 1-4
16382353|NCT00041327|Drug|zidovudine|300 mg bid
16382354|NCT00041314|Drug|carboplatin|
16382355|NCT00041314|Drug|exisulind|
16382356|NCT00041314|Drug|gemcitabine hydrochloride|
16382357|NCT00041301|Other|QoL assessment|qol questionnaires
16382358|NCT00041288|Biological|therapeutic allogeneic lymphocytes|
16382359|NCT00041288|Drug|cyclophosphamide|
16382360|NCT00041288|Drug|cyclosporine|
16382361|NCT00041288|Drug|fludarabine phosphate|
16382362|NCT00041288|Drug|methotrexate|
16382363|NCT00041288|Drug|mycophenolate mofetil|
16382364|NCT00041288|Drug|tacrolimus|
16382365|NCT00041288|Procedure|peripheral blood stem cell transplantation|
16382366|NCT00041288|Radiation|radiation therapy|
16382367|NCT00041262|Drug|cisplatin|
16382368|NCT00041262|Drug|epirubicin hydrochloride|
16382369|NCT00041262|Drug|fluorouracil|
16382370|NCT00041262|Procedure|conventional surgery|
16382371|NCT00041262|Procedure|neoadjuvant therapy|
16382372|NCT00041249|Drug|brostallicin|
16382373|NCT00041236|Drug|exatecan mesylate|
16382374|NCT00041223|Dietary Supplement|IH636 grape seed proanthocyanidin extract|
16382375|NCT00041210|Biological|bleomycin sulfate|
16382376|NCT00041210|Drug|ABVD regimen|
16382377|NCT00041210|Drug|Stanford V regimen|
16382378|NCT00041210|Drug|dacarbazine|
16382379|NCT00041210|Drug|doxorubicin hydrochloride|
16382380|NCT00041210|Drug|etoposide|
16382381|NCT00041210|Drug|mechlorethamine hydrochloride|
16382382|NCT00041210|Drug|prednisone|
16382383|NCT00041210|Drug|vinblastine sulfate|
16382384|NCT00041210|Drug|vincristine sulfate|
16382385|NCT00041210|Radiation|radiation therapy|
16382386|NCT00041197|Drug|imatinib mesylate|Given orally (PO)
16382387|NCT00041197|Other|placebo|Given PO
16382388|NCT00041197|Other|laboratory biomarker analysis|Correlative studies
16382389|NCT00041171|Drug|Hypericum perforatum|
16382390|NCT00041171|Drug|docetaxel|
16382391|NCT00041171|Other|placebo|
16382392|NCT00041132|Biological|filgrastim|5 ug/kg
16382393|NCT00041132|Biological|rituximab|375 mg/m^2 on day 1 of cycles 1-6
16382394|NCT00041132|Drug|cyclophosphamide|300 mg/m^2 on days 2-4 of cycles 1,3,5,7
16382395|NCT00041132|Drug|cytarabine|12 g/m^2 over days 3-4 of cycles 2,4,6,8
16382396|NCT00041132|Drug|dexamethasone|40 mg on days 2-5 and 12-15 of cycles 1,3,5,7
16382397|NCT00041132|Drug|doxorubicin|16.6 mg/m^2/day for days 5-7 of cycles 1,3,5,7
16382398|NCT00041132|Drug|leucovorin|170 mg over days 3-5 of cycles 2,4,6,8
16382399|NCT00041132|Drug|methotrexate|1000 mg/m^2 over days 2-3 of cycles 2,4,6,8
16382400|NCT00041132|Drug|vincristine|1.4 mg/m^2 on days 5 and 12 of cycles 1,3,5,7
16382401|NCT00041119|Drug|AC regimen|Given IV
16382402|NCT00041119|Drug|cyclophosphamide|Given IV
16382403|NCT00041119|Drug|doxorubicin hydrochloride|Given IV
16382404|NCT00041119|Drug|paclitaxel|Given IV
16382405|NCT00041106|Drug|gemcitabine hydrochloride|Given IV
16382406|NCT00041106|Drug|cisplatin|Given IV
16382407|NCT00041106|Drug|gefitinib|Given PO
16382408|NCT00041106|Other|laboratory biomarker analysis|Correlative studies
16382409|NCT00041093|Drug|Docetaxel|Given IV
16382410|NCT00041080|Drug|tamoxifen citrate|Given orally
16382411|NCT00041080|Drug|thalidomide|Given orally
16382412|NCT00041080|Other|laboratory biomarker analysis|Correlative studies
16382413|NCT00041067|Biological|filgrastim|
16382414|NCT00041067|Biological|trastuzumab|
16382415|NCT00041067|Drug|docetaxel|
16382416|NCT00041067|Drug|vinorelbine|
16382417|NCT00041054|Drug|carboplatin|
16382418|NCT00041054|Drug|etoposide|
16382419|NCT00041054|Drug|exisulind|
16382420|NCT00041041|Drug|imatinib mesylate|Given PO
16382421|NCT00041041|Other|laboratory biomarker analysis|Correlative studies
16382422|NCT00041028|Drug|EF5|
16382423|NCT00041028|Other|flow cytometry|
16382424|NCT00041028|Other|immunohistochemistry staining method|
16382425|NCT00041015|Drug|cisplatin|
16382426|NCT00041015|Drug|etoposide|
16382427|NCT00041015|Drug|topotecan hydrochloride|
16382428|NCT00040989|Drug|BAY 56-3722|
16382429|NCT00040989|Procedure|enzyme inhibitor therapy|
16382430|NCT00040950|Biological|rituximab|
16382431|NCT00040950|Drug|agatolimod sodium|
16382432|NCT00040937|Biological|filgrastim|PBSC collection: 10 mcg/kg SQ days 1-10
16382433|NCT00040937|Biological|sargramostim|"PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis
~1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery"
16382434|NCT00040937|Drug|cyclophosphamide|PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
16382435|NCT00040937|Drug|dexamethasone|40 mg/d PO days 1-4, 9-12, 17-20
16382436|NCT00040937|Drug|melphalan|"st trans: 140 mg/m2 IV over 20 mins day -1
~nd trans: 200mg/m2 IV over 20 mins day -1"
16382437|NCT00040937|Drug|prednisone|maint: 50 mg/d PO every other day until progression
16382438|NCT00040937|Drug|thalidomide|ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
16382439|NCT00040937|Procedure|peripheral blood stem cell transplantation|2-4 x 10^6/kg IV day 0
16382440|NCT00040911|Procedure|electroacupuncture therapy|
16382441|NCT00040911|Procedure|sham intervention|Undergo electroacupuncture therapy to sham points
16382442|NCT00040911|Procedure|quality-of-life assessment|Ancillary studies
16382443|NCT00040898|Dietary Supplement|Sho-saiko-to|
16382444|NCT00040885|Biological|infliximab|
16382445|NCT00040885|Drug|docetaxel|
16382446|NCT00040885|Other|placebo|
16382447|NCT00040872|Biological|filgrastim|
16382448|NCT00040872|Biological|monoclonal antibody 3F8|
16382449|NCT00040872|Biological|sargramostim|
16382450|NCT00040872|Drug|carboplatin|
16382451|NCT00040872|Drug|cisplatin|
16382452|NCT00040872|Drug|cyclophosphamide|
16382453|NCT00040872|Drug|doxorubicin hydrochloride|
16382454|NCT00040872|Drug|etoposide|
16382455|NCT00040872|Drug|isotretinoin|
16382456|NCT00040872|Drug|thiotepa|
16382457|NCT00040872|Drug|topotecan hydrochloride|
16382458|NCT00040872|Drug|vincristine sulfate|
16382459|NCT00040872|Procedure|autologous bone marrow transplantation|
16382460|NCT00040872|Procedure|bone marrow ablation with stem cell support|
16382461|NCT00040872|Procedure|conventional surgery|
16382462|NCT00040872|Procedure|drug resistance inhibition treatment|
16382463|NCT00040872|Procedure|peripheral blood stem cell transplantation|
16382464|NCT00040872|Procedure|syngeneic bone marrow transplantation|
16382465|NCT00040872|Radiation|radiation therapy|
16382466|NCT00040859|Drug|capecitabine|
16382467|NCT00040859|Drug|oxaliplatin|
16382468|NCT00040846|Biological|alemtuzumab|Given IV
16382469|NCT00040846|Drug|fludarabine phosphate|Given IV
16382470|NCT00040846|Radiation|total-body irradiation|Undergo TBI
16382471|NCT00040846|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic HSCT
16382472|NCT00040846|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16382473|NCT00040846|Drug|mycophenolate mofetil|Given PO
16382474|NCT00040846|Drug|cyclosporine|Given IV or PO
16382475|NCT00040833|Procedure|complementary or alternative medicine procedure|
16382476|NCT00040833|Procedure|pain therapy|
16382477|NCT00040807|Drug|docetaxel|
16382478|NCT00040807|Drug|irinotecan hydrochloride|
16382479|NCT00040794|Drug|paclitaxel|Given IV
16382480|NCT00040794|Drug|carboplatin|Given IV
16382481|NCT00040794|Drug|gefitinib|Given PO
16382482|NCT00040794|Radiation|radiation therapy|Undergo radiotherapy
16382483|NCT00040794|Other|laboratory biomarker analysis|Optional correlative studies
16382484|NCT00040781|Drug|gefitinib|Given orally
16382485|NCT00040781|Other|pharmacological study|Correlative studies
16382486|NCT00040781|Other|laboratory biomarker analysis|Correlative studies
16382487|NCT00040768|Drug|bortezomib|Given IV
16382488|NCT00040755|Drug|rebimastat|Given orally
16382489|NCT00040755|Other|laboratory biomarker analysis|Correlative studies
16382490|NCT00040742|Dietary Supplement|ginger|Given orally
16382491|NCT00040742|Other|placebo|Given orally
16382492|NCT00040690|Biological|filgrastim|
16382493|NCT00040690|Drug|cyclophosphamide|
16382494|NCT00040690|Drug|cytarabine|
16382495|NCT00040690|Drug|doxorubicin hydrochloride|
16382496|NCT00040690|Drug|etoposide|
16382497|NCT00040690|Drug|ifosfamide|
16382498|NCT00040690|Drug|leucovorin calcium|
16382499|NCT00040690|Drug|methotrexate|
16382500|NCT00040690|Drug|vincristine sulfate|
16382501|NCT00040690|Radiation|radiation therapy|
16382502|NCT00039611|Drug|FOLFOX regimen|
16382503|NCT00039611|Drug|fluorouracil|
16382504|NCT00039611|Drug|leucovorin calcium|
16382505|NCT00039611|Drug|oxaliplatin|
16382506|NCT00039585|Drug|imatinib mesylate|
16382507|NCT00039572|Drug|boronophenylalanine-fructose complex|
16382508|NCT00039559|Other|Early detection|CA125 is measured in blood and the longitudinal results interpreted with a statistical algorithm to determine if there has been a significant increase from baseline.
16382509|NCT00039546|Drug|cyclophosphamide|
16382510|NCT00039546|Drug|epirubicin hydrochloride|
16382511|NCT00039546|Drug|gemcitabine hydrochloride|
16382512|NCT00039546|Drug|paclitaxel|
16382513|NCT00039546|Procedure|adjuvant therapy|
16382514|NCT00039520|Drug|docetaxel|
16382515|NCT00039520|Drug|sulindac|
16382516|NCT00039507|Procedure|conventional surgery|
16382517|NCT00039507|Procedure|radiofrequency ablation|
16382518|NCT00039494|Drug|erlotinib hydrochloride|Given orally
16382519|NCT00039494|Radiation|3-dimensional conformal radiation therapy|
16382520|NCT00039494|Drug|temozolomide|Given orally
16382521|NCT00039481|Biological|oblimersen sodium|Given IV
16382522|NCT00039481|Drug|dexrazoxane hydrochloride|Given IV
16382523|NCT00039481|Drug|doxorubicin hydrochloride|Given IV
16382524|NCT00039481|Drug|cyclophosphamide|Given IV
16382525|NCT00039481|Biological|filgrastim|Given SC
16382526|NCT00039481|Other|laboratory biomarker analysis|Correlative studies
16382527|NCT00039481|Other|pharmacological study|Correlative studies
16382528|NCT00039468|Drug|irinotecan hydrochloride|350 or 700 mg/m2 IV every 3 weeks
16382529|NCT00039468|Drug|thalidomide|400mg/day oral
16382530|NCT00039455|Biological|trastuzumab|Given IV
16382531|NCT00039455|Drug|alvocidib|Given IV
16382532|NCT00039455|Other|laboratory biomarker analysis|Correlative studies
16382533|NCT00039455|Other|pharmacological study|Correlative studies
16382534|NCT00039442|Drug|Capecitabine|Given orally
16382535|NCT00039442|Other|Laboratory Biomarker Analysis|Correlative studies
16382536|NCT00039429|Drug|atrasentan hydrochloride|
16382537|NCT00039416|Drug|imatinib mesylate|Given orally
16382538|NCT00039416|Other|laboratory biomarker analysis|Correlative studies
16382539|NCT00039403|Drug|7-hydroxystaurosporine|Given IV
16382540|NCT00039403|Drug|gemcitabine hydrochloride|Given IV
16382541|NCT00039403|Other|pharmacological study|Correlative studies
16382542|NCT00039403|Other|laboratory biomarker analysis|Correlative studies
16382543|NCT00039390|Drug|capecitabine|Given orally (PO)
16382544|NCT00039390|Drug|gefitinib|Given PO
16382545|NCT00039390|Other|pharmacological study|Correlative studies
16382546|NCT00039390|Other|laboratory biomarker analysis|Correlative studies
16382547|NCT00039377|Drug|imatinib mesylate|Given PO
16382548|NCT00039377|Drug|methotrexate|Given IT and IV
16382549|NCT00039377|Drug|vincristine sulfate|Given IV
16382550|NCT00039377|Drug|leucovorin calcium|Given IV and PO
16382551|NCT00039377|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16382552|NCT00039377|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSCT
16382553|NCT00039377|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSCT
16382554|NCT00039377|Radiation|total-body irradiation|Undergo TBI
16382555|NCT00039377|Drug|tacrolimus|Given IV or PO
16382556|NCT00039377|Biological|filgrastim|Given SC
16382557|NCT00039377|Drug|etoposide|Given IV
16382558|NCT00039377|Drug|cyclophosphamide|Given IV
16382559|NCT00039377|Drug|cytarabine|Given IV
16382560|NCT00039377|Other|laboratory biomarker analysis|Correlative studies
16382561|NCT00039364|Drug|imatinib mesylate|
16382562|NCT00039351|Drug|cyclophosphamide|
16382563|NCT00039351|Drug|prednisone|
16382564|NCT00039351|Drug|vincristine sulfate|
16382565|NCT00039351|Radiation|radiation therapy|
16382566|NCT00039338|Procedure|conventional surgery|Radial hysterectomy
16382567|NCT00039338|Procedure|neoadjuvant chemotherapy|Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
16382568|NCT00039338|Radiation|brachytherapy|Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.
16382569|NCT00039338|Radiation|radiation therapy|Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
16382570|NCT00039338|Drug|cisplatin|Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).
16382571|NCT00039325|Biological|dendritic cell-MART-1 peptide vaccine|Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
16382572|NCT00039312|Other|Papanicolaou test|
16382573|NCT00039312|Other|cytology specimen collection procedure|
16382574|NCT00039312|Procedure|annual screening|
16382575|NCT00039312|Procedure|colposcopic biopsy|
16382576|NCT00039312|Procedure|comparison of screening methods|
16382577|NCT00039299|Biological|therapeutic autologous lymphocytes|
16382578|NCT00039286|Procedure|positron emission tomography|
16382579|NCT00039286|Procedure|radionuclide imaging|
16382580|NCT00039286|Radiation|fludeoxyglucose F 18|
16382581|NCT00039273|Biological|panitumumab|
16382582|NCT00039234|Biological|aldesleukin|
16382583|NCT00039234|Drug|histamine dihydrochloride|
16382584|NCT00039208|Drug|fluorouracil|
16382585|NCT00039208|Drug|irinotecan hydrochloride|
16382586|NCT00039208|Drug|leucovorin calcium|
16382587|NCT00039208|Drug|oxaliplatin|
16382588|NCT00039195|Biological|filgrastim|
16382589|NCT00039195|Biological|rituximab|
16382590|NCT00039195|Drug|carboplatin|
16382591|NCT00039195|Drug|cyclophosphamide|
16382592|NCT00039195|Drug|doxorubicin hydrochloride|
16382593|NCT00039195|Drug|etoposide|
16382594|NCT00039195|Drug|ifosfamide|
16382595|NCT00039195|Drug|prednisone|
16382596|NCT00039195|Drug|vincristine sulfate|
16382597|NCT00039195|Procedure|peripheral blood stem cell transplantation|
16382598|NCT00039195|Radiation|radiation therapy|
16382599|NCT00039182|Drug|erlotinib hydrochloride|Given orally
16382600|NCT00039182|Other|laboratory biomarker analysis|Correlative studies
16382601|NCT00039156|Drug|ortataxel|
16382602|NCT00039130|Biological|filgrastim|5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII
16382603|NCT00039130|Biological|rituximab|Day 8 course II 50 mg/sq m IV infusion: d 8 course IV & VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
16382604|NCT00039130|Drug|cyclophosphamide|200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
16382605|NCT00039130|Drug|cytarabine|1 g/sq m/day IV infusion Days 4 & 5, courses II, IV, VI
16382606|NCT00039130|Drug|dexamethasone|10mg/sq m PO or IV Days 1-5 courses II-VII
16382607|NCT00039130|Drug|doxorubicin hydrochloride|25 mg/sq m/day IV infusion Days 4 & 5 courses III,V, VII
16382608|NCT00039130|Drug|etoposide|80 mg/sq m/day IV infusion Days 4 & 5 courses II, IV, VI
16382609|NCT00039130|Drug|ifosfamide|800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
16382610|NCT00039130|Drug|leucovorin calcium|25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX <10nM, courses II-VII
16382611|NCT00039130|Drug|methotrexate|1.5 g/sq m IV infusion Day 1 courses II-VII
16382612|NCT00039130|Drug|prednisone|60 mg/sq m PO/day Days 1-7 course I
16382613|NCT00039130|Drug|vincristine sulfate|2 mg IV push Day 1 courses II-VII
16382614|NCT00039130|Drug|Allopurinol|300 mg/day PO Days 1-14, course I
16382615|NCT00039117|Biological|oblimersen sodium|Given IV
16382616|NCT00039117|Drug|cytarabine|Given IV
16382617|NCT00039117|Drug|daunorubicin hydrochloride|Given IV
16382618|NCT00039117|Other|laboratory biomarker analysis|Correlative studies
16382619|NCT00039117|Other|pharmacological study|Correlative studies
16382620|NCT00039104|Drug|rebimastat|Given PO
16382621|NCT00039104|Drug|zoledronic acid|Given IV
16382622|NCT00039104|Other|laboratory biomarker analysis|Correlative studies
16382623|NCT00039091|Biological|ipilimumab|Given IV
16382624|NCT00039078|Radiation|yttrium Y 90 glass microspheres|
16382625|NCT00039052|Biological|interleukin-4 PE38KDEL cytotoxin|
16382626|NCT00039039|Drug|carboplatin|
16382627|NCT00039039|Drug|chemotherapy|
16382628|NCT00039039|Drug|cisplatin|
16382629|NCT00039039|Drug|paclitaxel|
16382630|NCT00039039|Radiation|radiation therapy|
16382631|NCT00037037|Biological|MAGE-10.A2|
16382632|NCT00037037|Biological|MART-1 antigen|
16382633|NCT00037037|Biological|NY-ESO-1 peptide vaccine|
16382634|NCT00037037|Biological|sargramostim|
16382635|NCT00037037|Biological|tyrosinase peptide|
16382636|NCT00037024|Procedure|fatigue assessment and management|
16382637|NCT00037024|Procedure|nutritional support|
16382638|NCT00037024|Procedure|physical therapy|
16382639|NCT00037024|Procedure|psychosocial assessment and care|
16382640|NCT00037024|Procedure|quality-of-life assessment|
16382641|NCT00037011|Biological|beta-glucan|
16382642|NCT00037011|Biological|monoclonal antibody 3F8|
16382643|NCT00036998|Procedure|conventional surgery|
16382644|NCT00036998|Procedure|neoadjuvant therapy|
16382645|NCT00036998|Procedure|thermal ablation therapy|
16382646|NCT00036985|Drug|cyclophosphamide|
16382647|NCT00036985|Drug|doxorubicin hydrochloride|
16382648|NCT00036985|Procedure|conventional surgery|
16382649|NCT00036985|Procedure|neoadjuvant therapy|
16382650|NCT00036985|Procedure|thermal ablation therapy|
16382651|NCT00036972|Biological|cintredekin besudotox|
16382652|NCT00036972|Procedure|adjuvant therapy|
16382653|NCT00036972|Procedure|conventional surgery|
16382654|NCT00036972|Procedure|neoadjuvant therapy|
16382655|NCT00036959|Drug|ABT-751|
16382656|NCT00036946|Biological|ziv-aflibercept|
16382657|NCT00036933|Biological|MUC-2-Globo H-KLH conjugate vaccine|
16382658|NCT00036933|Biological|QS21|
16382659|NCT00036894|Drug|lenalidomide|
16382660|NCT00036881|Dietary Supplement|zinc sulfate|
16382661|NCT00036881|Other|placebo|
16382662|NCT00036868|Biological|trastuzumab|
16382663|NCT00036868|Drug|CMF regimen|
16382664|NCT00036868|Drug|cyclophosphamide|
16382665|NCT00036868|Drug|fluorouracil|
16382666|NCT00036868|Drug|methotrexate|
16382667|NCT00036855|Biological|rituximab|Given IV
16382668|NCT00036855|Radiation|indium In 111 ibritumomab tiuxetan|Given IV
16382669|NCT00036855|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16382670|NCT00036855|Procedure|peripheral blood stem cell transplantation|Undergo PBSC transplantation
16382671|NCT00036855|Biological|filgrastim|Given subcutaneously
16382672|NCT00036855|Other|laboratory biomarker analysis|Correlative studies
16382673|NCT00036842|Drug|arsenic trioxide|
16382674|NCT00036829|Procedure|pain therapy|
16382675|NCT00036816|Biological|MART-1 antigen|
16382676|NCT00036816|Biological|NA17-A antigen|
16382677|NCT00036816|Biological|gp100 antigen|
16382678|NCT00036816|Biological|tyrosinase peptide|
16382679|NCT00036790|Drug|doxorubicin hydrochloride|
16382680|NCT00036790|Drug|motexafin gadolinium|
16382681|NCT00036777|Drug|carboplatin|Given IV
16382682|NCT00036777|Drug|7-hydroxystaurosporine|Given IV
16382683|NCT00036777|Other|pharmacological study|Correlative studies
16382684|NCT00036764|Drug|ixabepilone|Given IV
16382685|NCT00036764|Other|pharmacogenomic studies|Correlative studies
16382686|NCT00036764|Other|laboratory biomarker analysis|Correlative studies
16382687|NCT00036751|Drug|imatinib mesylate|Given orally
16382688|NCT00036751|Other|laboratory biomarker analysis|Correlative studies
16382689|NCT00036738|Drug|Cyclosporine|Given IV or PO
16382690|NCT00036738|Drug|Dasatinib|Given PO
16382691|NCT00036738|Drug|Fludarabine Phosphate|Given IV
16382692|NCT00036738|Drug|Imatinib Mesylate|Given PO
16382693|NCT00036738|Drug|Mycophenolate Mofetil|Given PO
16382694|NCT00036738|Drug|Nilotinib|Given PO
16382695|NCT00036738|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
16382696|NCT00036738|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplantation
16382697|NCT00036738|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
16382698|NCT00036738|Radiation|Total-Body Irradiation|Undergo TBI
16382699|NCT00036712|Procedure|management of therapy complications|
16382700|NCT00036712|Procedure|pain therapy|
16382701|NCT00036686|Dietary Supplement|Soy protein isolate|Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
16382702|NCT00036686|Other|Placebo|Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
16382703|NCT00033748|Biological|monoclonal antibody 11D10 anti-idiotype|2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
16382704|NCT00033748|Biological|monoclonal antibody 3H1 Alu Gel|2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
16382705|NCT00033709|Drug|temozolomide|
16382706|NCT00033709|Drug|thalidomide|
16382707|NCT00033696|Biological|filgrastim|
16382708|NCT00033696|Drug|carboplatin|
16382709|NCT00033696|Drug|etoposide|
16382710|NCT00033696|Drug|paclitaxel|
16382711|NCT00033696|Drug|topotecan hydrochloride|
16382712|NCT00033696|Radiation|radiation therapy|
16382713|NCT00033683|Drug|CMF regimen|
16382714|NCT00033683|Drug|cyclophosphamide|
16382715|NCT00033683|Drug|docetaxel|
16382716|NCT00033683|Drug|epirubicin hydrochloride|
16382717|NCT00033683|Drug|fluorouracil|
16382718|NCT00033683|Drug|methotrexate|
16382719|NCT00033683|Drug|tamoxifen citrate|
16382720|NCT00033683|Procedure|adjuvant therapy|
16382721|NCT00033683|Radiation|radiation therapy|
16382722|NCT00033657|Drug|cisplatin|"Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29
~Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
16382723|NCT00033657|Drug|irinotecan hydrochloride|"Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29
~Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
16382724|NCT00033657|Drug|paclitaxel|"Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29
~Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles"
16382725|NCT00033657|Procedure|conventional surgery|The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
16382726|NCT00033657|Radiation|radiation therapy|The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.
16382727|NCT00033644|Biological|sargramostim|
16382728|NCT00033644|Drug|cisplatin|
16382729|NCT00033644|Drug|dacarbazine|
16382730|NCT00033644|Drug|doxorubicin hydrochloride|
16382731|NCT00033644|Drug|mitomycin C|
16382810|NCT00032175|Drug|gemcitabine hydrochloride|
16382811|NCT00032162|Drug|carboplatin|AUC 6 q4w
16382812|NCT00032162|Drug|pegylated liposomal doxorubicin hydrochloride|20/30/40 mg/qm q4w Dose finding study
16382813|NCT00032149|Biological|bleomycin sulfate|
16382814|NCT00032149|Biological|filgrastim|
16382732|NCT00033631|Radiation|70.2 Gy 3D-CRT/IMRT|Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
16382733|NCT00033631|Radiation|79.2 Gy 3D-CRT/IMRT|Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
16382734|NCT00033618|Drug|ixabepilone|Given IV
16382735|NCT00033618|Other|laboratory biomarker analysis|Correlative studies
16382736|NCT00033605|Drug|octreotide acetate|
16382737|NCT00033605|Other|placebo|
16382738|NCT00033605|Radiation|radiation|
16382739|NCT00033566|Drug|S-3304|
16382740|NCT00033553|Drug|carboplatin|Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
16382741|NCT00033553|Drug|gemcitabine hydrochloride|1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
16382742|NCT00033553|Drug|paclitaxel|225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
16382743|NCT00033553|Radiation|radiation therapy|3-D XRT 7400 cGy total after induction (during cycles 3-9)
16382744|NCT00033540|Drug|capecitabine|650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
16382745|NCT00033540|Drug|gemcitabine hydrochloride|1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
16382746|NCT00033514|Biological|trastuzumab|Day 1 4mg/kg IV 2 mg/kg IV weekly.
16382747|NCT00033514|Drug|erlotinib hydrochloride|100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.
16382748|NCT00033488|Other|cytology specimen collection procedure|
16382749|NCT00033488|Procedure|annual screening|
16382750|NCT00033488|Procedure|comparison of screening methods|
16382751|NCT00033475|Biological|therapeutic allogeneic lymphocytes|
16382752|NCT00033449|Drug|gefitinib|Given orally
16382753|NCT00033449|Radiation|radiation therapy|Undergo radiation therapy
16382754|NCT00033449|Drug|cisplatin|Given IV
16382755|NCT00033449|Other|laboratory biomarker analysis|Correlative studies
16382756|NCT00033436|Dietary Supplement|niacinamide|
16382757|NCT00033436|Drug|carbogen|
16382758|NCT00033436|Radiation|radiation therapy|
16382759|NCT00033423|Biological|rituximab|
16382760|NCT00033423|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16382761|NCT00033410|Drug|carboplatin|
16382762|NCT00033410|Drug|paclitaxel|
16382763|NCT00033410|Drug|tirapazamine|
16382764|NCT00033410|Radiation|radiation therapy|
16382765|NCT00033397|Procedure|biopsy|
16382766|NCT00033397|Procedure|magnetic resonance imaging|
16382767|NCT00033397|Procedure|radiomammography|
16382768|NCT00033397|Procedure|ultrasound imaging|
16382769|NCT00033397|Radiation|gadopentetate dimeglumine|
16382770|NCT00033397|Drug|chemotherapy|
16382771|NCT00033371|Drug|Celecoxib|Given 400 mg PO twice a day
16382772|NCT00033371|Other|Placebo|Given PO to match DFMO
16382773|NCT00033371|Drug|eflornithine|Given PO at 0.5 gm/m^2/day rounded down to the nearest 250 mg dose (BSA of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day).
16382774|NCT00033371|Other|Laboratory biomarker analysis|Correlative studies
16382775|NCT00033371|Other|Questionnaire administration|Ancillary studies
16382776|NCT00033358|Drug|medroxyprogesterone|Given intramuscularly
16382777|NCT00033358|Drug|ethinyl estradiol|Given orally
16382778|NCT00033358|Drug|norgestrel|Given orally
16382779|NCT00033358|Other|laboratory biomarker analysis|Correlative studies
16382780|NCT00033345|Drug|Indole-3-carbinol|400 mg pill taken daily
16382781|NCT00033345|Drug|Indole-3-carbinol|800 mg pill taken daily
16382782|NCT00033345|Other|Placebo|Placebo pill taken daily during run-in period
16382783|NCT00033332|Drug|dexamethasone|
16382784|NCT00033332|Drug|pamidronate disodium|
16382785|NCT00033332|Drug|thalidomide|
16382786|NCT00033332|Drug|zoledronic acid|
16382787|NCT00033293|Biological|therapeutic immune globulin|Given IV
16382788|NCT00033293|Other|clinical observation|Undergo observation
16382789|NCT00033293|Drug|cyclophosphamide|Given IV
16382790|NCT00033293|Drug|prednisone|Given orally
16382791|NCT00033293|Procedure|magnetic resonance imaging|Correlative studies
16382792|NCT00033293|Other|laboratory biomarker analysis|Correlative studies
16382793|NCT00033293|Drug|Corticotropin-Releasing Hormone|administered subcutaneously
16382794|NCT00033280|Drug|temozolomide|
16382795|NCT00033280|Procedure|neoadjuvant therapy|
16382796|NCT00033280|Radiation|radiation therapy|
16382797|NCT00033267|Drug|temsirolimus|Given IV
16382798|NCT00033254|Radiation|radiation therapy|Undergo conventional radiation therapy
16382799|NCT00033254|Drug|thalidomide|Given orally
16382800|NCT00033254|Procedure|quality-of-life assessment|Ancillary studies
16382801|NCT00033241|Drug|erlotinib hydrochloride|
16382802|NCT00033241|Drug|gemcitabine hydrochloride|
16382803|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 500 ug
16382804|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 1000 ug
16382805|NCT00033228|Biological|MKC1106-MT|Cancer Vaccine, Immunotherapy, 1500 ug
16382806|NCT00032188|Biological|aldesleukin|Given subcutaneously
16382807|NCT00032188|Drug|bryostatin 1|Given IV
16382808|NCT00032188|Other|laboratory biomarker analysis|Correlative studies
16382815|NCT00032149|Drug|cyclophosphamide|
16382816|NCT00032149|Drug|etoposide|
16382817|NCT00032149|Drug|mitoxantrone hydrochloride|
16382818|NCT00032149|Drug|prednisolone|
16382819|NCT00032149|Drug|vincristine sulfate|
16382820|NCT00032136|Drug|exemestane|
16382821|NCT00032136|Drug|tamoxifen citrate|
16382822|NCT00032136|Procedure|adjuvant therapy|
16382823|NCT00032123|Drug|erlotinib hydrochloride|
16382824|NCT00032110|Drug|erlotinib hydrochloride|Given orally
16382825|NCT00032110|Other|pharmacological study|Correlative studies
16382826|NCT00032110|Other|laboratory biomarker analysis|Correlative studies
16382827|NCT00032097|Drug|motexafin gadolinium|
16382828|NCT00032097|Radiation|radiation therapy|
16382829|NCT00032084|Behavioral|smoking cessation intervention|Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy
16382830|NCT00032084|Drug|bupropion hydrochloride|150 mg/day on Days 1-3, 300 mg/day on Day 4-77
16382831|NCT00032084|Drug|nicotine|21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.
16382832|NCT00032084|Procedure|psychosocial assessment and care|The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).
16382833|NCT00032058|Procedure|magnetic resonance imaging|
16382834|NCT00032058|Procedure|magnetic resonance spectroscopic imaging|
16382835|NCT00032045|Biological|gp100 antigen|
16382836|NCT00032045|Biological|incomplete Freund's adjuvant|
16382837|NCT00032045|Biological|ipilimumab|
16382838|NCT00032032|Drug|carboplatin|
16382839|NCT00032032|Drug|paclitaxel|
16382840|NCT00032032|Radiation|radiation therapy|
16382841|NCT00032019|Biological|filgrastim|Cycle 1: 300 ug (BW < = 70 kg) or 480ug (BW >70 kg) sub Q injection Day 6 until ANC > 5000/uL after nadir counts Subsequent cycle dosages based on previous cycle toxicity or Day 1 Tx toxicity
16382842|NCT00032019|Biological|rituximab|375 mg/sq m IV infusion Day 1 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 of tx toxicities
16382843|NCT00032019|Drug|cyclophosphamide|750 mg/sq m IV infusion on Day 5 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 treatment toxicities
16382844|NCT00032019|Drug|doxorubicin hydrochloride|10 mg/sq m/day continuous IV infusion on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and Day 1 treatment toxicities
16382845|NCT00032019|Drug|etoposide|50 mg/sq m/day continuous IV infusion Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
16382846|NCT00032019|Drug|prednisone|60 mg/sq m PO bid days 1-5 of ea cycle
16382847|NCT00032019|Drug|vincristine sulfate|0.4 mg/sq m/day continuous IV infusion uncapped on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
16382848|NCT00032006|Radiation|brachytherapy|
16382849|NCT00032006|Radiation|radiation therapy|
16382850|NCT00031993|Drug|erlotinib hydrochloride|Given PO
16382851|NCT00031993|Other|laboratory biomarker analysis|Correlative studies
16382852|NCT00031980|Drug|cyclosporine|
16382853|NCT00031967|Drug|therapeutic melatonin|
16382854|NCT00031967|Radiation|radiation therapy|
16382855|NCT00031941|Drug|lenalidomide|
16382856|NCT00031928|Drug|mafosfamide|
16382857|NCT00031915|Drug|imatinib mesylate|
16382858|NCT00031902|Biological|bleomycin sulfate|
16382859|NCT00031902|Biological|rituximab|
16382860|NCT00031902|Drug|prednisolone|
16382861|NCT00031902|Drug|vincristine sulfate|
16382862|NCT00031876|Drug|capecitabine|
16382863|NCT00031876|Drug|paclitaxel|
16382864|NCT00031863|Drug|rofecoxib|
16382865|NCT00031863|Procedure|adjuvant therapy|
16382866|NCT00031850|Drug|goserelin acetate|
16382867|NCT00031850|Drug|raloxifene|
16382868|NCT00031837|Drug|dalteparin|
16382869|NCT00031837|Drug|gemcitabine hydrochloride|
16382870|NCT00031837|Procedure|quality-of-life assessment|
16382871|NCT00031824|Drug|cyclosporine|
16382872|NCT00031824|Drug|hydroxychloroquine|
16382873|NCT00031824|Drug|prednisone|
16382874|NCT00031824|Drug|tacrolimus|
16382875|NCT00031798|Drug|methylphenidate hydrochloride|
16382876|NCT00031798|Procedure|quality-of-life assessment|
16382877|NCT00031798|Radiation|radiation therapy|
16382878|NCT00031772|Procedure|psychosocial assessment and care|Questionnaire and telephone intervention
16382879|NCT00031759|Drug|imiquimod|
16382880|NCT00031759|Procedure|Ablative or excisional therapy|
16382881|NCT00031746|Dietary Supplement|soy protein isolate|25 mg daily
16382882|NCT00031746|Dietary Supplement|casein proteins|25 mg daily
16382883|NCT00031733|Biological|MART-1 antigen|
16382884|NCT00031733|Biological|gp100 antigen|
16382885|NCT00031733|Biological|incomplete Freund's adjuvant|
16382886|NCT00031733|Biological|recombinant interleukin-12|
16382887|NCT00031733|Biological|sargramostim|
16382888|NCT00031733|Biological|tyrosinase peptide|
16382889|NCT00031733|Drug|alum adjuvant|
16382890|NCT00031733|Procedure|adjuvant therapy|
16382891|NCT00031720|Dietary Supplement|soy protein|Given orally
16382892|NCT00031720|Dietary Supplement|isoflavones|Given orally
16382893|NCT00031720|Drug|Tamoxifen|
16382894|NCT00031720|Other|Placebo|Oral
16382895|NCT00031694|Drug|paclitaxel|Given IV
16382896|NCT00031694|Drug|bryostatin 1|Given IV
16382897|NCT00031681|Drug|7-hydroxystaurosporine|Given IV
16382898|NCT00031681|Drug|irinotecan hydrochloride|Given IV
16382899|NCT00031681|Other|diagnostic laboratory biomarker analysis|Correlative studies
16382984|NCT00030628|Radiation|WBRT|
16383513|NCT00025103|Drug|carboplatin|
16382900|NCT00031655|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSCT
16382901|NCT00031655|Biological|donor lymphocytes|Given IV
16382902|NCT00031655|Drug|cyclosporine|Given PO
16382903|NCT00031655|Radiation|total-body irradiation|Undergo TBI
16382904|NCT00031655|Drug|fludarabine phosphate|Given IV
16382905|NCT00031655|Drug|mycophenolate mofetil|Given PO
16382906|NCT00031655|Other|laboratory biomarker analysis|Correlative studies
16382907|NCT00031655|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSCT
16382908|NCT00031642|Biological|rituximab|
16382909|NCT00031642|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16382910|NCT00031629|Drug|Docetaxel|Given IV
16382911|NCT00031629|Biological|Filgrastim|Given SC
16382912|NCT00031629|Drug|Gemcitabine Hydrochloride|Given IV
16382913|NCT00031629|Biological|Pegfilgrastim|Given IV
16382914|NCT00031616|Drug|brivudine phosphoramidate|
16382915|NCT00031590|Drug|Cisplatin|Given at a dose of 70mg/m2 by intravenous (IV) infusion over 8 hours on day 0 of each cycle (Regimen A only).
16382916|NCT00031590|Drug|Cyclophosphamide|Given at a dose of 1g/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Administration of cyclophosphamide will always be preceded by prehydration and Mesna (Regimen B only).
16382917|NCT00031590|Drug|Etoposide|Given at a dose of 150mg/m2/day by IV infusion on days 0 and 1 of a 6-week cycle. Given orally at a dose of 50mg/m2 as a single daily dose for 21 days beginning on day 14 of a cycle (Regimen B only).
16382918|NCT00031590|Drug|Lomustine|Given at a dose of 75mg/m2 taken orally on days 0 of each 6-week cycle with vincristine and cisplatin (Regimen A only).
16382919|NCT00031590|Drug|Vincristine|Given at a dose of 1.5mg/m2 given by IV infusion once a week for the first six weeks of treatment during radiation therapy. During maintenance therapy, it will be given as an IV push on days 0, 7 and 14 of each 6-week cycle (Regimen A only).
16382920|NCT00031590|Radiation|Craniospinal Radiation|Craniospinal radiation will begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with chemotherapy (vincristine).
16382921|NCT00031577|Drug|paclitaxel|
16382922|NCT00031577|Radiation|radiation therapy|
16382923|NCT00031564|Biological|Interleukin-2|
16382924|NCT00031564|Biological|B7-1|
16382925|NCT00030914|Drug|medroxyprogesterone|
16382926|NCT00030914|Drug|venlafaxine|
16382927|NCT00030901|Drug|L-selenomethionine|Randomization between active L-selenomethionine and placebo
16382928|NCT00030901|Drug|L-selenomethionine placebo|Randomization between active L-selenomethionine and placebo
16382929|NCT00030888|Drug|7-hydroxystaurosporine|
16382930|NCT00030875|Drug|bortezomib|
16382931|NCT00030862|Drug|cisplatin|
16382932|NCT00030862|Drug|irinotecan hydrochloride|
16382933|NCT00030849|Biological|recombinant interferon alfa|
16382934|NCT00030849|Drug|bexarotene|
16382935|NCT00030823|Biological|Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine|
16382936|NCT00030823|Biological|QS21|
16382937|NCT00030810|Radiation|Hyperfractionated|Hyperfractionated radiotherapy
16382938|NCT00030810|Drug|Taxotere/Cisplatin|Taxotere/Cisplatin
16382939|NCT00030810|Procedure|conventional surgery|conventional surgery
16382940|NCT00030784|Drug|ifosfamide|
16382941|NCT00030784|Drug|pegylated liposomal doxorubicin hydrochloride|
16382942|NCT00030771|Drug|Chemotherapy|Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
16382943|NCT00030771|Radiation|Radiotherapy|Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
16382944|NCT00030771|Procedure|Surgery|3-4 weeks after termination of radiotherapy
16382945|NCT00030758|Biological|filgrastim|
16382946|NCT00030758|Biological|pegfilgrastim|
16382947|NCT00030745|Drug|cisplatin|
16382948|NCT00030745|Drug|gemcitabine hydrochloride|
16382949|NCT00030745|Procedure|conventional surgery|
16382950|NCT00030732|Drug|Gemcitabine + Capecitabine|Gemcitabine + Capecitabine
16382951|NCT00030732|Drug|Gemcitabine alone|Gemcitabine alone
16382952|NCT00030719|Biological|filgrastim|
16382953|NCT00030719|Biological|monoclonal antibody Ch14.18|
16382954|NCT00030719|Drug|busulfan|
16382955|NCT00030719|Drug|carboplatin|
16382956|NCT00030719|Drug|cyclophosphamide|
16382957|NCT00030719|Drug|etoposide|
16382958|NCT00030719|Drug|isotretinoin|
16382959|NCT00030719|Drug|melphalan|
16382960|NCT00030719|Drug|vincristine sulfate|
16382961|NCT00030719|Procedure|bone marrow ablation with stem cell support|
16382962|NCT00030719|Procedure|conventional surgery|
16382963|NCT00030719|Procedure|peripheral blood stem cell transplantation|
16382964|NCT00030719|Radiation|radiation therapy|
16382965|NCT00030706|Drug|ixabepilone|
16382966|NCT00030693|Biological|recombinant fowlpox-B7.1 vaccine|Given intratumorally
16382967|NCT00030693|Biological|recombinant fowlpox-TRICOM vaccine|Given intratumorally
16382968|NCT00030693|Other|laboratory biomarker analysis|Correlative studies
16382969|NCT00030693|Procedure|quality-of-life assessment|Ancillary studies
16382970|NCT00030680|Radiation|radiation therapy|
16382971|NCT00030654|Drug|bicalutamide|
16382972|NCT00030654|Drug|docetaxel|
16382973|NCT00030654|Drug|doxorubicin hydrochloride|
16382974|NCT00030654|Drug|estramustine phosphate sodium|
16382975|NCT00030654|Drug|flutamide|
16382976|NCT00030654|Drug|ketoconazole|
16382977|NCT00030654|Drug|paclitaxel|
16382978|NCT00030654|Drug|releasing hormone agonist therapy|
16382979|NCT00030654|Drug|vinblastine sulfate|
16382980|NCT00030641|Biological|oblimersen sodium|
16382981|NCT00030641|Drug|docetaxel|
16382982|NCT00030628|Radiation|radiation therapy|
16382983|NCT00030628|Procedure|surgery|
16382985|NCT00030615|Drug|decitabine|Given IV
16382986|NCT00030615|Other|pharmacological study|Correlative studies
16382987|NCT00030615|Other|laboratory biomarker analysis|Correlative studies
16382988|NCT00030589|Drug|bexarotene|
16382989|NCT00030589|Drug|methoxsalen|
16382990|NCT00030589|Procedure|UV light therapy|
16382991|NCT00030576|Drug|cisplatin|
16382992|NCT00030576|Drug|erlotinib hydrochloride|
16382993|NCT00030563|Drug|irinotecan hydrochloride|
16382994|NCT00030563|Procedure|adjuvant therapy|
16382995|NCT00030563|Procedure|conventional surgery|
16382996|NCT00030563|Procedure|radiofrequency ablation|
16382997|NCT00030550|Drug|thalidomide|
16382998|NCT00030537|Drug|erlotinib hydrochloride|
16382999|NCT00030511|Drug|fluorouracil|
16383000|NCT00030511|Procedure|conventional surgery|
16383001|NCT00030511|Radiation|radiation therapy|
16383002|NCT00030498|Drug|erlotinib hydrochloride|Given orally
16383003|NCT00030498|Other|laboratory biomarker analysis|Correlative studies
16383004|NCT00030485|Drug|erlotinib hydrochloride|
16383005|NCT00030472|Drug|pegylated liposomal doxorubicin hydrochloride|
16383006|NCT00030459|Drug|cisplatin|
16383007|NCT00030459|Drug|mitomycin C|
16383008|NCT00030459|Drug|vinblastine sulfate|
16383009|NCT00030459|Drug|vinorelbine tartrate|
16383010|NCT00030433|Drug|gemcitabine hydrochloride|
16383011|NCT00030433|Drug|irinotecan hydrochloride|
16383012|NCT00030407|Drug|Celecoxib|On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals
16383013|NCT00030407|Drug|Docetaxel|On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.
16383014|NCT00030394|Drug|imatinib mesylate|Given orally
16383015|NCT00030394|Other|laboratory biomarker analysis|Correlative studies
16383016|NCT00030394|Other|pharmacological study|Correlative studies
16383017|NCT00030355|Drug|homoharringtonine|
16383018|NCT00030355|Procedure|chemotherapy|
16383019|NCT00030342|Biological|recombinant interferon alfa|
16383020|NCT00030342|Biological|sargramostim|
16383021|NCT00030342|Biological|therapeutic autologous lymphocytes|
16383022|NCT00030342|Drug|fluorouracil|
16383023|NCT00030303|Biological|recombinant 70-kD heat-shock protein|
16383024|NCT00030290|Procedure|high-intensity focused ultrasound ablation|
16383025|NCT00030277|Procedure|high-intensity focused ultrasound ablation|
16383026|NCT00030264|Drug|Methotrexate|Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)
16383027|NCT00030264|Drug|Vinblastine|Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg.
16383028|NCT00030108|Drug|ixabepilone|
16383029|NCT00030095|Drug|2-methoxyestradiol|
16383030|NCT00030082|Drug|isolated perfusion|
16383031|NCT00030082|Drug|melphalan|
16383032|NCT00029029|Procedure|pain therapy|
16383033|NCT00029029|Procedure|radiofrequency ablation|
16383034|NCT00029003|Drug|gefitinib|Given orally
16383035|NCT00029003|Other|laboratory biomarker analysis|Correlative studies
16383036|NCT00028990|Drug|bevacizumab|10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle
16383037|NCT00028990|Drug|Paclitaxel|90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest
16383038|NCT00028977|Drug|herba scutellaria barbata|
16383039|NCT00028977|Other|herba scutellaria Barbatae (HSB)|
16383040|NCT00028964|Dietary Supplement|Chinese herbs|
16383041|NCT00028964|Drug|cyclophosphamide|
16383042|NCT00028964|Drug|doxorubicin hydrochloride|
16383043|NCT00028964|Procedure|adjuvant therapy|
16383044|NCT00028951|Drug|fibrin sealant|
16383045|NCT00028951|Procedure|surgical wound closure|
16383046|NCT00028912|Drug|bortezomib|
16383047|NCT00028912|Drug|carboplatin|
16383048|NCT00028899|Drug|asparaginase|
16383049|NCT00028899|Drug|cytarabine|
16383050|NCT00028899|Drug|gemtuzumab ozogamicin|
16383051|NCT00028899|Drug|mitoxantrone hydrochloride|
16383052|NCT00028886|Biological|filgrastim|
16383053|NCT00028886|Biological|recombinant interferon alfa|
16383054|NCT00028886|Drug|cyclophosphamide|
16383055|NCT00028886|Drug|dexamethasone|
16383056|NCT00028886|Drug|doxorubicin hydrochloride|
16383057|NCT00028886|Drug|melphalan|
16383058|NCT00028886|Drug|thalidomide|
16383059|NCT00028886|Drug|vincristine sulfate|
16383060|NCT00028886|Procedure|bone marrow ablation with stem cell support|
16383061|NCT00028886|Procedure|peripheral blood stem cell transplantation|
16383062|NCT00028873|Drug|docetaxel|
16383063|NCT00028873|Drug|laniquidar|
16383064|NCT00028873|Drug|paclitaxel|
16383065|NCT00028860|Biological|filgrastim|
16383066|NCT00028860|Drug|carboplatin|
16383067|NCT00028860|Drug|gemcitabine hydrochloride|
16383068|NCT00028860|Drug|ifosfamide|
16383069|NCT00028860|Drug|paclitaxel|
16383070|NCT00028860|Procedure|adjuvant therapy|
16383071|NCT00028847|Drug|cytarabine|
16383072|NCT00028847|Drug|imatinib mesylate|
16383073|NCT00028834|Drug|gemcitabine hydrochloride|Given IV
16383074|NCT00028834|Biological|bevacizumab|Given IV
16383075|NCT00028834|Other|laboratory biomarker analysis|Correlative studies
16383076|NCT00028821|Drug|2-methoxyestradiol|Given orally
16383077|NCT00028821|Other|pharmacological study|Correlative studies
16383078|NCT00028821|Other|laboratory biomarker analysis|Correlative studies
16383079|NCT00028795|Drug|temozolomide|
16383080|NCT00028795|Procedure|adjuvant therapy|
16383081|NCT00028795|Radiation|radiation therapy|
16383082|NCT00028782|Drug|etanidazole|Given IV
16383083|NCT00028782|Procedure|therapeutic conventional surgery|Undergo surgery
16383084|NCT00028782|Other|laboratory biomarker analysis|Correlative studies
16383085|NCT00028769|Drug|bicalutamide|
16383086|NCT00028769|Drug|estramustine|
16383087|NCT00028769|Drug|etoposide|
16383088|NCT00028769|Drug|flutamide|
16383089|NCT00028769|Drug|goserelin|
16383090|NCT00028769|Drug|leuprolide|
16383091|NCT00028769|Drug|nilutamide|
16383092|NCT00028769|Drug|paclitaxel|
16383093|NCT00028756|Drug|doxorubicin hydrochloride|Given IV
16383094|NCT00028756|Drug|gemcitabine hydrochloride|Given IV
16383095|NCT00028756|Drug|vinblastine sulfate|Given IV
16383096|NCT00028756|Drug|methotrexate|Given IV
16383097|NCT00028756|Drug|cisplatin|Given IV
16383098|NCT00028756|Biological|filgrastim|Given SC
16383099|NCT00028743|Drug|carboplatin|Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
16383100|NCT00028743|Drug|cisplatin|4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle
16383101|NCT00028743|Drug|paclitaxel|Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
16383102|NCT00028743|Drug|topotecan hydrochloride|"4 cycles
~.75mg/m2 (30 mins) days 1-5 of 21 day cycle"
16383103|NCT00028730|Biological|anti-thymocyte globulin|
16383104|NCT00028730|Biological|filgrastim|
16383105|NCT00028730|Drug|cyclophosphamide|
16383106|NCT00028730|Drug|fludarabine phosphate|
16383107|NCT00028730|Drug|thiotepa|
16383108|NCT00028730|Procedure|allogeneic bone marrow transplantation|
16383109|NCT00028730|Radiation|radiation therapy|
16383110|NCT00028717|Biological|filgrastim|
16383111|NCT00028717|Biological|rituximab|
16383112|NCT00028717|Drug|cyclophosphamide|
16383113|NCT00028717|Drug|doxorubicin hydrochloride|
16383114|NCT00028717|Drug|prednisone|
16383115|NCT00028717|Drug|vincristine sulfate|
16383116|NCT00028704|Procedure|conventional surgery|
16383117|NCT00028704|Radiation|radiation therapy|
16383118|NCT00028691|Drug|chlorambucil|
16383119|NCT00028691|Radiation|radiation therapy|
16383120|NCT00028665|Biological|filgrastim|Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.
16383121|NCT00028665|Biological|rituximab|rituximab IV over 2-5 hours on days 1, 8, and 15
16383122|NCT00028665|Drug|carmustine|After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3
16383123|NCT00028665|Drug|cisplatin|After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.
16383124|NCT00028665|Drug|cyclophosphamide|cyclophosphamide IV over 3-6 hours on day 16.
16383125|NCT00028665|Drug|etoposide|After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.
16383126|NCT00028665|Procedure|bone marrow ablation with stem cell support|Patients then undergo peripheral blood stem cell (PBSC) collection.
16383127|NCT00028665|Procedure|peripheral blood stem cell transplantation|Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.
16383128|NCT00028665|Radiation|radiation therapy|Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.
16383129|NCT00028652|Biological|interleukin-12 gene|
16383130|NCT00028639|Drug|bortezomib|
16383131|NCT00028626|Drug|embolization therapy|
16383132|NCT00028600|Biological|filgrastim|PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC >= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC > 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2
16383133|NCT00028600|Biological|CD34+ cells|2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
16383134|NCT00028600|Drug|cyclophosphamide|4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep
16383135|NCT00028600|Drug|fludarabine phosphate|30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl
16383136|NCT00028600|Drug|melphalan|200mg/sq m IV infusion over 15-30 min D 2 auto transpl
16383137|NCT00028600|Drug|methotrexate|5mg/sq m/d IV infusion D 1,3,& 6: allo transpl
16383138|NCT00028600|Drug|tacrolimus|0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150
16383139|NCT00028587|Drug|bortezomib|Given IV
16383140|NCT00028587|Drug|paclitaxel|Given IV
16383141|NCT00028587|Drug|carboplatin|Given IV
16383142|NCT00028587|Other|laboratory biomarker analysis|Optional correlative studies
16383143|NCT00028574|Drug|gabapentin|
16383144|NCT00028574|Other|placebo|
16383145|NCT00028561|Drug|ixabepilone|Given IV
16383146|NCT00028561|Drug|carboplatin|Given IV
16383147|NCT00028561|Other|laboratory biomarker analysis|Correlative studies
16383148|NCT00028561|Other|pharmacological study|Correlative studies
16383149|NCT00028548|Drug|R(+)XK469|
16383150|NCT00028535|Biological|trastuzumab|Given IV
16383151|NCT00028535|Drug|paclitaxel|Given IV
16383152|NCT00028535|Biological|recombinant interleukin-12|Given SC
16383153|NCT00028522|Drug|R(+)XK469|Given IV
16383154|NCT00028509|Procedure|management of therapy complications|
16383155|NCT00028496|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|Given intradermally
16383156|NCT00028496|Biological|sargramostim|Given subcutaneously
16383157|NCT00028496|Biological|recombinant fowlpox GM-CSF vaccine adjuvant|Given intradermally
16383158|NCT00028028|Drug|temsirolimus|Given IV
16383159|NCT00028028|Other|pharmacological study|Correlative studies
16383160|NCT00028028|Other|laboratory biomarker analysis|Correlative studies
16383161|NCT00028015|Drug|SarCNU|
16383404|NCT00025441|Drug|cyclophosphamide|
16383162|NCT00028002|Procedure|Conventional Surgery|Undergo surgical resection
16383163|NCT00028002|Drug|Imatinib Mesylate|Given orally
16383164|NCT00027989|Drug|gemcitabine hydrochloride|
16383165|NCT00027989|Drug|pegylated liposomal doxorubicin hydrochloride|
16383166|NCT00027976|Drug|celecoxib|
16383167|NCT00027976|Drug|Placebo|
16383168|NCT00027963|Drug|gabapentin|
16383169|NCT00027963|Other|placebo|
16383170|NCT00027937|Biological|aldesleukin|
16383171|NCT00027937|Biological|filgrastim|
16383172|NCT00027937|Biological|sargramostim|
16383173|NCT00027937|Drug|busulfan|
16383174|NCT00027937|Drug|cyclophosphamide|
16383175|NCT00027937|Drug|melphalan|
16383176|NCT00027937|Drug|paclitaxel|
16383177|NCT00027937|Drug|thiotepa|
16383178|NCT00027937|Procedure|bone marrow ablation with stem cell support|
16383179|NCT00027937|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16383180|NCT00027911|Biological|NY-ESO-1 peptide vaccine|
16383181|NCT00027911|Biological|sargramostim|
16383182|NCT00027898|Drug|bortezomib|Given IV
16383183|NCT00027898|Drug|carboplatin|Given IV
16383184|NCT00027898|Drug|etoposide|Given IV
16383185|NCT00027898|Other|laboratory biomarker analysis|Correlative studies
16383186|NCT00027898|Other|pharmacological study|Correlative studies
16383187|NCT00027885|Biological|bevacizumab|Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
16383188|NCT00027885|Drug|cyclophosphamide|Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16383189|NCT00027885|Drug|docetaxel|Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
16383190|NCT00027885|Drug|doxorubicin hydrochloride|Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
16383191|NCT00027885|Procedure|adjuvant therapy|"After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
~Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
16383192|NCT00027885|Procedure|conventional surgery|After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
16383193|NCT00027885|Procedure|neoadjuvant therapy|"Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
~Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
16383194|NCT00027885|Radiation|radiation therapy|Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
16383195|NCT00027872|Drug|tipifarnib|Given orally
16383196|NCT00027872|Other|laboratory biomarker analysis|Correlative studies
16383197|NCT00027859|Drug|docetaxel|
16383198|NCT00027859|Drug|estramustine phosphate sodium|
16383199|NCT00027859|Drug|ketoconazole|
16383200|NCT00027859|Drug|therapeutic hydrocortisone|
16383201|NCT00027846|Biological|filgrastim|Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.
16383202|NCT00027846|Drug|carboplatin|Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA <0.45m2 the dose is 12.5 mg/kg/day.
16383203|NCT00027846|Drug|cyclophosphamide|Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
16383204|NCT00027846|Drug|etoposide|Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA < 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
16383205|NCT00027846|Drug|vincristine sulfate|Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA<0.45m2 the dose is 0.05mg/kg.
16383206|NCT00027846|Radiation|radiation therapy|Given once daily 5 days a week for 6-6½ weeks
16383207|NCT00027846|Drug|Mesna|Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.
16383208|NCT00027846|Procedure|therapeutic conventional surgery|
16383209|NCT00027833|Biological|ALVAC-CEA-B7.1 vaccine|
16383210|NCT00027833|Biological|tetanus toxoid|
16383211|NCT00027833|Drug|FOLFIRI regimen|
16383212|NCT00027833|Drug|fluorouracil|
16383213|NCT00027833|Drug|irinotecan hydrochloride|
16383214|NCT00027833|Drug|leucovorin calcium|
16383215|NCT00027820|Drug|Fludarabine Phosphate|Given IV
16383216|NCT00027820|Radiation|Total-Body Irradiation|Undergo TBI
16383217|NCT00027820|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo nonmyeloablative PBSCT
16383218|NCT00027820|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative PBSCT
16383219|NCT00027820|Drug|Cyclosporine|Given PO
16383220|NCT00027820|Drug|Mycophenolate Mofetil|Given PO
16383221|NCT00027807|Biological|Aldesleukin|Subcutaneous injections of IL-2 (3.0 × 105 IU/m2/day) starting 3 days before the 1st armed ATC infusion and ending 7 days after the last armed ATC infusion.
16383222|NCT00027807|Biological|Sargramostim|GM-CSF Injections will be given SQ GM-CSF (250 μg/m2/twice weekly), to start 3 days before the first ATC infusion and ending 1 week after the last ATC infusion.
16383223|NCT00027807|Biological|therapeutic autologous lymphocytes|The time for armed-ATC infusions will vary from patient to patient, but the dose of armed-ATC (up to 40 billion) will be given over 30 min.
16383512|NCT00025103|Biological|dactinomycin|
16383224|NCT00027794|Procedure|conventional surgery|
16383225|NCT00027781|Drug|sabarubicin|
16383226|NCT00027768|Procedure|adjuvant therapy|
16383227|NCT00027768|Radiation|iodine I 131 ethiodized oil|
16383228|NCT00027742|Biological|pegylated interferon alfa|
16383229|NCT00027742|Drug|temozolomide|
16383230|NCT00027729|Biological|etaracizumab|
16383231|NCT00027716|Drug|bortezomib|
16383232|NCT00027703|Drug|gemcitabine hydrochloride|Given IV
16383233|NCT00027703|Drug|cisplatin|Given IV
16383234|NCT00027703|Biological|bevacizumab|Given IV
16383235|NCT00027703|Other|placebo|Given IV
16383236|NCT00027703|Other|laboratory biomarker analysis|Correlative studies
16383237|NCT00027690|Drug|Gefitinib|Given orally
16383238|NCT00027690|Other|Laboratory Biomarker Analysis|Correlative studies
16383239|NCT00027677|Drug|halofuginone hydrobromide|
16383240|NCT00027664|Biological|recombinant interferon alfa|
16383241|NCT00027664|Drug|thalidomide|
16383242|NCT00027638|Drug|thalidomide|
16383243|NCT00027625|Drug|gefitinib|
16383244|NCT00027625|Drug|temozolomide|
16383245|NCT00027586|Drug|Imatinib mesylate (STI571)|400 mg twice a day orally
16383246|NCT00027573|Biological|filgrastim|
16383247|NCT00027573|Biological|therapeutic allogeneic lymphocytes|
16383248|NCT00027573|Drug|cyclophosphamide|
16383249|NCT00027573|Drug|fludarabine phosphate|
16383250|NCT00027573|Drug|methotrexate|
16383251|NCT00027573|Drug|tacrolimus|
16383252|NCT00027573|Procedure|peripheral blood stem cell transplantation|
16383253|NCT00027560|Biological|alemtuzumab|"Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft.
~Campath-1H (20mg/dose/day) will be administered for each of four days from day -8 to day -5, inclusive. Each dose will be infused intravenously over 8 hours."
16383254|NCT00027560|Drug|cyclosporine|Patients will be treated with Cyclosporine as prophylaxis against GvHD. Cyclosporine will be initiated at least 1 day prior to transplant at a dose of 1.5 mg / kg IV q12h (3 mg / kg / day = total daily dose). Dose will thereafter be adjusted to maintain a trough serum level of 200-300 ng /ml. Cyclosporine will be administered intravenously until the patient tolerates full alimentation, at which time conversion to oral dosing to sustain therapeutic levels will be initiated according to standard BMT service guidelines.
16383255|NCT00027560|Drug|fludarabine phosphate|Fludarabine, 25mg/m2/d will be administered for each of five days from day -8 to day -4, inclusive. Each dose will be infused intravenously over 30 minutes.
16383256|NCT00027560|Drug|melphalan|Melphalan will be administered intravenously over 30 minutes on each of two days from day -3 to day -2, inclusive. The dose for recipients of HLA-matched related grafts will be 50 mg/m2/day x 2. The dose for recipients of HLA-matched unrelated and HLA-single allele disparate related or unrelated marrow or PBSC transplants will be 70 mg/m2/day x 2.
16383257|NCT00027560|Procedure|allogeneic bone marrow transplantation|
16383258|NCT00027560|Procedure|peripheral blood stem cell transplantation|
16383259|NCT00027547|Biological|therapeutic allogeneic lymphocytes|
16383260|NCT00027547|Drug|cyclosporine|
16383261|NCT00027547|Drug|cytarabine|
16383262|NCT00027547|Drug|fludarabine phosphate|
16383263|NCT00027547|Drug|methotrexate|
16383264|NCT00027547|Drug|mycophenolate mofetil|
16383265|NCT00027547|Procedure|allogeneic bone marrow transplantation|
16383266|NCT00027547|Procedure|peripheral blood stem cell transplantation|
16383267|NCT00027547|Radiation|radiation therapy|
16383268|NCT00027534|Biological|TRICOM-CEA(6D)|dendritic cells loaded with TRICOM-CEA(6D)
16383269|NCT00027495|Dietary Supplement|curcumin|
16383270|NCT00026533|Drug|thalidomide|
16383271|NCT00026494|Drug|temozolomide|
16383272|NCT00026494|Drug|vinorelbine tartrate|
16383273|NCT00026468|Drug|exisulind|
16383274|NCT00026442|Drug|capecitabine|
16383275|NCT00026416|Biological|recombinant interferon alfa|
16383276|NCT00026416|Drug|thalidomide|
16383277|NCT00026416|Procedure|adjuvant therapy|
16383278|NCT00026403|Drug|cisplatin|
16383279|NCT00026403|Drug|gemcitabine hydrochloride|
16383280|NCT00026403|Radiation|radiation therapy|
16383281|NCT00026338|Drug|erlotinib hydrochloride|150 mg po daily
16383282|NCT00026338|Drug|gemcitabine hydrochloride|1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)
16383283|NCT00026312|Biological|Aldesleukin|Given IV
16383284|NCT00026312|Biological|Dinutuximab|Given IV
16383285|NCT00026312|Drug|Isotretinoin|Given PO
16383286|NCT00026312|Other|Laboratory Biomarker Analysis|Correlative studies
16383287|NCT00026312|Other|Pharmacological Study|Correlative studies
16383288|NCT00026312|Other|Quality-of-Life Assessment|Ancillary studies
16383289|NCT00026312|Biological|Sargramostim|Given IV or SC
16383290|NCT00026299|Drug|ZD1839|
16383291|NCT00026299|Drug|oxaliplatin|
16383292|NCT00026247|Procedure|pain therapy|
16383293|NCT00026247|Procedure|radiofrequency ablation|
16383294|NCT00026234|Drug|floxuridine|Given intra-arterially
16383295|NCT00026234|Drug|dexamethasone|Given intra-arterially
16383296|NCT00026234|Drug|oxaliplatin|Given IV
16383297|NCT00026234|Drug|capecitabine|Given orally
16383298|NCT00026221|Biological|Recombinant Interferon Alfa|Given SC
16383299|NCT00026221|Biological|Bevacizumab|Given IV
16383300|NCT00026208|Drug|Vincristine|1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
16383301|NCT00026208|Drug|Cyclophosphamide|650 mg/m², on week 1 and 5
16383302|NCT00026208|Drug|Doxorubicin|25 mg/m², on week 1, 3, 5, 7
16383303|NCT00026208|Drug|Prednisone|40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
16383304|NCT00026208|Drug|Bleomycin|5 u/m² intravenously (IV) on week 2, 4, 6, 8
16383305|NCT00026208|Drug|Etoposide|60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
16383306|NCT00026208|Radiation|Low-dose radiotherapy (RT)|20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
16383307|NCT00026195|Drug|irinotecan hydrochloride|
16383308|NCT00026182|Biological|rituximab|Given IV
16383309|NCT00026182|Biological|recombinant interleukin-12|Given SC
16383310|NCT00026182|Other|laboratory biomarker analysis|Correlative studies
16383311|NCT00026182|Other|questionnaire administration|Ancillary studies
16383312|NCT00026182|Procedure|quality-of-life assessment|Ancillary studies
16383313|NCT00026169|Drug|imatinib mesylate|Given orally
16383314|NCT00026169|Other|laboratory biomarker analysis|Correlative studies
16383315|NCT00026169|Other|pharmacological study|Correlative studies
16383316|NCT00026156|Drug|docetaxel|
16383317|NCT00026156|Drug|vinorelbine tartrate|
16383318|NCT00026143|Biological|recombinant interleukin-12|Given IV
16383319|NCT00026143|Biological|recombinant interferon alfa|Given SC
16383320|NCT00026143|Other|laboratory biomarker analysis|Correlative studies
16383321|NCT00026130|Drug|fluorouracil|200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
16383322|NCT00026130|Drug|gemcitabine hydrochloride|200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
16383323|NCT00026130|Radiation|radiation therapy|4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
16383324|NCT00026117|Drug|BenFin|
16383325|NCT00026117|Other|placebo|
16383326|NCT00026104|Drug|gemcitabine hydrochloride|Given IV
16383327|NCT00026104|Drug|paclitaxel|Given IV
16383328|NCT00026104|Drug|tipifarnib|Given orally
16383329|NCT00026104|Radiation|radiation therapy|Undergo radiation therapy
16383330|NCT00026091|Drug|fenretinide|Given orally
16383331|NCT00026091|Other|laboratory biomarker analysis|Correlative studies
16383332|NCT00026091|Other|pharmacological study|Correlative studies
16383333|NCT00026078|Drug|docetaxel|
16383334|NCT00026078|Drug|ifosfamide|
16383335|NCT00025675|Drug|gefitinib|
16383336|NCT00025662|Drug|RFT5-SMPT-dgA|A specific anti-interleukin-2 receptor immunotoxin
16383337|NCT00025662|Drug|Isolex system|CD34 selection/ T cell depletion used this system
16383338|NCT00025649|Biological|filgrastim|
16383339|NCT00025649|Drug|busulfan|
16383340|NCT00025649|Drug|carboplatin|
16383341|NCT00025649|Drug|cyclophosphamide|
16383342|NCT00025649|Drug|doxorubicin hydrochloride|
16383343|NCT00025649|Drug|etoposide|
16383344|NCT00025649|Drug|melphalan|
16383345|NCT00025649|Drug|vincristine sulfate|
16383346|NCT00025649|Procedure|autologous bone marrow transplantation|
16383347|NCT00025649|Procedure|conventional surgery|
16383348|NCT00025649|Procedure|peripheral blood stem cell transplantation|
16383349|NCT00025636|Biological|filgrastim|
16383350|NCT00025636|Drug|carmustine|
16383351|NCT00025636|Drug|cisplatin|
16383352|NCT00025636|Drug|cyclophosphamide|
16383353|NCT00025636|Drug|cytarabine|
16383354|NCT00025636|Drug|dexamethasone|
16383355|NCT00025636|Drug|etoposide|
16383356|NCT00025636|Drug|melphalan|
16383357|NCT00025636|Drug|methotrexate|
16383358|NCT00025636|Drug|vincristine sulfate|
16383359|NCT00025636|Procedure|bone marrow ablation with stem cell support|
16383360|NCT00025636|Procedure|peripheral blood stem cell transplantation|
16383361|NCT00025623|Drug|carboplatin|
16383362|NCT00025623|Drug|cyclophosphamide|
16383363|NCT00025623|Drug|doxorubicin hydrochloride|
16383364|NCT00025623|Drug|etoposide|
16383365|NCT00025623|Drug|vincristine sulfate|
16383366|NCT00025623|Procedure|conventional surgery|
16383367|NCT00025610|Drug|carboplatin|
16383368|NCT00025610|Drug|cyclophosphamide|
16383369|NCT00025610|Drug|doxorubicin hydrochloride|
16383370|NCT00025610|Drug|etoposide|
16383371|NCT00025610|Drug|vincristine sulfate|
16383372|NCT00025597|Drug|carboplatin|
16383373|NCT00025597|Drug|cyclophosphamide|
16383374|NCT00025597|Drug|doxorubicin hydrochloride|
16383375|NCT00025597|Drug|etoposide|
16383376|NCT00025597|Drug|vincristine sulfate|
16383377|NCT00025597|Procedure|conventional surgery|
16383378|NCT00025584|Drug|bortezomib|Given IV
16383379|NCT00025584|Other|laboratory biomarker analysis|Correlative studies
16383380|NCT00025558|Biological|filgrastim|
16383381|NCT00025558|Drug|carboplatin|
16383382|NCT00025558|Drug|temozolomide|
16383383|NCT00025558|Drug|thiotepa|
16383384|NCT00025558|Procedure|autologous bone marrow transplantation|
16383385|NCT00025558|Procedure|peripheral blood stem cell transplantation|
16383386|NCT00025519|Biological|therapeutic allogeneic lymphocytes|
16383387|NCT00025519|Drug|fludarabine phosphate|
16383388|NCT00025519|Drug|mycophenolate mofetil|
16383389|NCT00025519|Drug|tacrolimus|
16383390|NCT00025519|Drug|thalidomide|
16383391|NCT00025519|Procedure|peripheral blood stem cell transplantation|
16383392|NCT00025519|Radiation|radiation therapy|
16383393|NCT00025506|Other|Laboratory Biomarker Analysis|Correlative studies
16383394|NCT00025506|Drug|Thalidomide|Given orally
16383395|NCT00025493|Drug|docetaxel|
16383396|NCT00025480|Drug|carboplatin|
16383397|NCT00025480|Drug|paclitaxel|
16383398|NCT00025480|Drug|tipifarnib|
16383399|NCT00025480|Radiation|radiation therapy|
16383400|NCT00025454|Drug|tipifarnib|
16383401|NCT00025441|Biological|dactinomycin|
16383402|NCT00025441|Biological|filgrastim|
16383403|NCT00025441|Drug|carboplatin|
16383405|NCT00025441|Drug|doxorubicin hydrochloride|
16383406|NCT00025441|Drug|epirubicin hydrochloride|
16383407|NCT00025441|Drug|etoposide|
16383408|NCT00025441|Drug|ifosfamide|
16383409|NCT00025441|Drug|vincristine sulfate|
16383410|NCT00025441|Procedure|peripheral blood stem cell transplantation|
16383411|NCT00025441|Radiation|radiation therapy|
16383412|NCT00025428|Drug|carboplatin|
16383413|NCT00025428|Drug|cyclophosphamide|
16383414|NCT00025428|Drug|doxorubicin hydrochloride|
16383415|NCT00025428|Drug|etoposide|
16383416|NCT00025428|Drug|vincristine sulfate|
16383417|NCT00025428|Procedure|adjuvant therapy|
16383418|NCT00025428|Procedure|conventional surgery|
16383419|NCT00025428|Procedure|neoadjuvant therapy|
16383420|NCT00025415|Drug|imatinib mesylate|Given orally
16383421|NCT00025415|Other|pharmacological study|Correlative studies
16383422|NCT00025402|Biological|filgrastim|
16383423|NCT00025402|Biological|recombinant interferon alfa|
16383424|NCT00025402|Drug|busulfan|
16383425|NCT00025402|Drug|cyclophosphamide|
16383426|NCT00025402|Drug|cytarabine|
16383427|NCT00025402|Drug|etoposide|
16383428|NCT00025402|Drug|hydroxyurea|
16383429|NCT00025402|Drug|idarubicin|
16383430|NCT00025402|Procedure|allogeneic bone marrow transplantation|
16383431|NCT00025402|Procedure|peripheral blood stem cell transplantation|
16383432|NCT00025402|Radiation|radiation therapy|
16383433|NCT00025389|Biological|bevacizumab|
16383434|NCT00025389|Drug|carboplatin|
16383435|NCT00025389|Drug|paclitaxel|
16383436|NCT00025389|Procedure|conventional surgery|
16383437|NCT00025389|Procedure|neoadjuvant therapy|
16383438|NCT00025363|Drug|vincristine sulfate|Given IV
16383439|NCT00025363|Drug|irinotecan hydrochloride|Given IV
16383440|NCT00025363|Drug|cyclophosphamide|Given IV
16383441|NCT00025363|Drug|doxorubicin hydrochloride|Given IV
16383442|NCT00025363|Drug|ifosfamide|Given IV
16383443|NCT00025363|Drug|etoposide|Given IV
16383444|NCT00025363|Drug|tirapazamine|Given IV
16383445|NCT00025363|Biological|filgrastim|Given SC
16383446|NCT00025363|Biological|sargramostim|Given SC
16383447|NCT00025363|Other|pharmacological study|Correlative studies
16383448|NCT00025363|Other|pharmacogenomic studies|Correlative studies
16383449|NCT00025363|Other|laboratory biomarker analysis|Correlative studies
16383450|NCT00025337|Biological|bevacizumab|Given IV
16383451|NCT00025337|Drug|oxaliplatin|Given IV
16383452|NCT00025337|Drug|leucovorin calcium|Given IV
16383453|NCT00025337|Drug|fluorouracil|Given IV
16383454|NCT00025324|Biological|filgrastim|
16383455|NCT00025324|Drug|carboplatin|
16383456|NCT00025324|Drug|cyclophosphamide|
16383457|NCT00025324|Drug|etoposide|
16383458|NCT00025324|Drug|thiotepa|
16383459|NCT00025324|Procedure|autologous bone marrow transplantation|
16383460|NCT00025324|Procedure|bone marrow ablation with stem cell support|
16383461|NCT00025324|Procedure|conventional surgery|
16383462|NCT00025324|Procedure|peripheral blood stem cell transplantation|
16383463|NCT00025324|Radiation|radiation therapy|
16383464|NCT00025311|Drug|topotecan hydrochloride|
16383465|NCT00025298|Drug|amifostine trihydrate|
16383466|NCT00025298|Drug|carboplatin|
16383467|NCT00025298|Drug|cisplatin|
16383468|NCT00025298|Drug|paclitaxel|
16383469|NCT00025298|Radiation|radiation therapy|
16383470|NCT00025285|Drug|carboplatin|
16383471|NCT00025285|Drug|irinotecan hydrochloride|
16383472|NCT00025285|Drug|thalidomide|
16383473|NCT00025272|Drug|carboplatin|
16383474|NCT00025272|Drug|etoposide|
16383475|NCT00025272|Drug|topotecan hydrochloride|
16383476|NCT00025272|Radiation|radiation therapy|
16383477|NCT00025259|Biological|Bleomycin Sulfate|Given IV or SC
16383478|NCT00025259|Drug|Cisplatin|Given IV
16383479|NCT00025259|Drug|Cyclophosphamide|Given IV
16383480|NCT00025259|Drug|Cytarabine|Given IV
16383481|NCT00025259|Drug|Dexamethasone|Given IV
16383482|NCT00025259|Drug|Doxorubicin Hydrochloride|Given IV
16383483|NCT00025259|Drug|Etoposide|Given IV
16383484|NCT00025259|Biological|Filgrastim|Given SC
16383485|NCT00025259|Radiation|Involved-Field Radiation Therapy|Undergo IFRT
16383486|NCT00025259|Drug|Prednisone|Given orally
16383487|NCT00025259|Drug|Vincristine Sulfate Liposome|Given IV
16383488|NCT00025246|Drug|imatinib mesylate|Given orally
16383489|NCT00025246|Other|laboratory biomarker analysis|Correlative studies
16383490|NCT00025233|Biological|bevacizumab|Given IV
16383491|NCT00025233|Other|laboratory biomarker analysis|Correlative studies
16383492|NCT00025220|Drug|Thalidomide|Given PO
16383493|NCT00025220|Other|Laboratory Biomarker Analysis|Correlative studies
16383494|NCT00025194|Drug|estramustine phosphate sodium|
16383495|NCT00025194|Drug|ixabepilone|
16383496|NCT00025181|Biological|MART-1 antigen|
16383497|NCT00025181|Biological|gp100 antigen|
16383498|NCT00025181|Biological|incomplete Freund's adjuvant|
16383499|NCT00025181|Biological|ipilimumab|
16383500|NCT00025181|Biological|tyrosinase peptide|
16383501|NCT00025181|Procedure|adjuvant therapy|
16383502|NCT00025168|Drug|gemcitabine hydrochloride|
16383503|NCT00025168|Drug|irinotecan hydrochloride|
16383504|NCT00025168|Radiation|radiation therapy|
16383505|NCT00025155|Drug|ixabepilone|Given IV
16383506|NCT00025142|Drug|FOLFOX regimen|
16383507|NCT00025142|Drug|fluorouracil|
16383508|NCT00025142|Drug|gefitinib|
16383509|NCT00025142|Drug|leucovorin calcium|
16383510|NCT00025142|Drug|oxaliplatin|
16383511|NCT00025129|Drug|laromustine|
16383514|NCT00025103|Drug|cyclophosphamide|
16383515|NCT00025103|Drug|doxorubicin hydrochloride|
16383516|NCT00025103|Drug|etoposide|
16383517|NCT00025103|Drug|melphalan|
16383518|NCT00025103|Drug|vincristine sulfate|
16383519|NCT00025103|Procedure|autologous bone marrow transplantation|
16383520|NCT00025103|Procedure|conventional surgery|
16383521|NCT00025103|Procedure|peripheral blood stem cell transplantation|
16383522|NCT00025103|Radiation|radiation therapy|
16383523|NCT00025090|Drug|cisplatin|
16383524|NCT00025090|Drug|fluorouracil|
16383525|NCT00025090|Drug|mitomycin C|
16383526|NCT00025090|Radiation|radiation therapy|
16383527|NCT00025077|Biological|filgrastim|
16383528|NCT00025077|Drug|carboplatin|
16383529|NCT00025077|Drug|cyclophosphamide|
16383530|NCT00025077|Drug|thiotepa|
16383531|NCT00025077|Procedure|conventional surgery|
16383532|NCT00025077|Procedure|peripheral blood stem cell transplantation|
16383533|NCT00025077|Radiation|radiation therapy|
16383534|NCT00025064|Biological|bleomycin sulfate|
16383535|NCT00025064|Drug|chlorambucil|
16383536|NCT00025064|Drug|cisplatin|
16383537|NCT00025064|Drug|dacarbazine|
16383538|NCT00025064|Drug|doxorubicin hydrochloride|
16383539|NCT00025064|Drug|etoposide|
16383540|NCT00025064|Drug|ifosfamide|
16383541|NCT00025064|Drug|melphalan|
16383542|NCT00025064|Drug|prednisolone|
16383543|NCT00025064|Drug|procarbazine hydrochloride|
16383544|NCT00025064|Drug|vinblastine sulfate|
16383545|NCT00025064|Drug|vincristine sulfate|
16383546|NCT00025064|Procedure|peripheral blood stem cell transplantation|
16383547|NCT00025064|Radiation|radiation therapy|
16383548|NCT00025051|Drug|celecoxib|
16383549|NCT00025051|Procedure|anti-cytokine therapy|
16383550|NCT00025051|Procedure|antiangiogenesis therapy|
16383551|NCT00025051|Procedure|biological therapy|
16383552|NCT00025051|Procedure|cancer prevention intervention|
16383553|NCT00025051|Procedure|chemoprevention of cancer|
16383554|NCT00025051|Procedure|growth factor antagonist therapy|
16383555|NCT00025038|Drug|tipifarnib|Given orally
16383556|NCT00025038|Drug|isotretinoin|Given orally
16383557|NCT00025038|Drug|fludarabine phosphate|Given IV
16383558|NCT00025038|Drug|cytarabine|Given IV
16383559|NCT00025038|Radiation|radiation therapy|Undergo total body irradiation
16383560|NCT00025038|Drug|cyclophosphamide|Given IV
16383561|NCT00025038|Biological|anti-thymocyte globulin|Given IV
16383562|NCT00025038|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplant
16383563|NCT00025038|Procedure|double-unit umbilical cord blood transplantation|
16383564|NCT00025038|Procedure|umbilical cord blood transplantation|Undergo allogeneic cord blood transplant
16383565|NCT00025038|Other|laboratory biomarker analysis|Correlative studies
16383566|NCT00025025|Other|sample testing|
16383567|NCT00024466|Biological|GVAX|
16383568|NCT00024466|Procedure|Autologous transplant|
16383569|NCT00024453|Biological|teicoplanin|
16383570|NCT00024440|Biological|filgrastim|
16383571|NCT00024440|Biological|oblimersen sodium|
16383572|NCT00024440|Drug|cyclophosphamide|
16383573|NCT00024440|Drug|fludarabine phosphate|
16383574|NCT00024427|Drug|fluorouracil|High dose 5-FU
16383575|NCT00024427|Drug|gemcitabine hydrochloride|Normal dose to treat pancreatic cancer
16383576|NCT00024427|Drug|triacetyluridine|6 grams (12 tablets)
16383577|NCT00024414|Drug|DHA-paclitaxel|
16383578|NCT00024375|Drug|DHA-paclitaxel|
16383579|NCT00024349|Drug|fluorouracil|
16383580|NCT00024349|Drug|mitomycin C|
16383581|NCT00024349|Radiation|radiation therapy|
16383582|NCT00024336|Drug|tamoxifen citrate|
16383583|NCT00024336|Radiation|radiation therapy|
16383584|NCT00024297|Drug|warfarin|
16383585|NCT00024284|Drug|carboplatin|
16383586|NCT00024284|Drug|irinotecan hydrochloride|
16383587|NCT00024271|Biological|recombinant interferon gamma|
16383588|NCT00024271|Drug|cisplatin|
16383589|NCT00024271|Drug|doxorubicin hydrochloride|
16383590|NCT00024271|Drug|gemcitabine hydrochloride|
16383591|NCT00024271|Drug|mitomycin C|
16383592|NCT00024271|Procedure|conventional surgery|
16383593|NCT00024271|Procedure|hyperthermia treatment|
16383594|NCT00024271|Radiation|radiation therapy|
16383595|NCT00024258|Drug|arsenic trioxide|
16383596|NCT00024245|Drug|pralatrexate|
16383597|NCT00024245|Drug|probenecid|
16383598|NCT00024232|Biological|monoclonal antibody huJ591|
16383599|NCT00024193|Biological|filgrastim|
16383600|NCT00024193|Drug|busulfan|
16383601|NCT00024193|Drug|cisplatin|
16383602|NCT00024193|Drug|cyclophosphamide|
16383603|NCT00024193|Drug|doxorubicin hydrochloride|
16383604|NCT00024193|Drug|etoposide|
16383605|NCT00024193|Drug|melphalan|
16383606|NCT00024193|Drug|vincristine sulfate|
16383607|NCT00024193|Procedure|conventional surgery|
16383608|NCT00024193|Procedure|peripheral blood stem cell transplantation|
16383609|NCT00024180|Drug|romidepsin|
16383610|NCT00024167|Drug|Docetaxel|75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.
16383611|NCT00024167|Drug|Doxorubicin hydrochloride|20 mg/m2 IV, day 1 on Weeks 1, 3, 5
16383612|NCT00024167|Drug|Estramustine phosphate sodium|140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6
16383613|NCT00024167|Drug|Ketoconazole|400 mg orally (po) 3 x day, Days 1 through 7
16383614|NCT00024167|Drug|Prednisone|5 mg orally 2 x daily, weeks 1-14
16383615|NCT00024167|Drug|Vinblastine|4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6
16383616|NCT00024167|Radiation|Strontium chloride Sr 89|One dose (4 mCi total dose) IV
16383617|NCT00024167|Drug|Dexamethasone|4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
16383618|NCT00024154|Biological|trastuzumab|Given IV
16383619|NCT00024154|Drug|gefitinib|Given orally
16383620|NCT00024154|Other|laboratory biomarker analysis|Correlative studies
16383621|NCT00024115|Drug|BL22 immunotoxin|
16383622|NCT00024115|Procedure|antibody therapy|
16383623|NCT00024115|Procedure|biological response modifier therapy|
16383624|NCT00024115|Procedure|immunotoxin therapy|
16383625|NCT00024102|Drug|Standard Treatment|Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 & 8 and 5-FU 600 mg/sq m IV push d 1 & 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles
16383626|NCT00024102|Drug|capecitabine|2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles
16383627|NCT00024089|Drug|gefitinib|
16383628|NCT00024076|Procedure|radiofrequency ablation|
16383629|NCT00024050|Drug|busulfan|
16383630|NCT00024050|Drug|cyclophosphamide|
16383631|NCT00024050|Drug|cyclosporine|
16383632|NCT00024050|Drug|methotrexate|
16383633|NCT00024050|Procedure|allogeneic bone marrow transplantation|
16383634|NCT00024050|Procedure|peripheral blood stem cell transplantation|
16383635|NCT00023998|Drug|doxorubicin hydrochloride|Given IV
16383636|NCT00023998|Drug|cisplatin|Given IV
16383637|NCT00023998|Drug|methotrexate|Given IV
16383638|NCT00023998|Drug|leucovorin calcium|Given IV or orally
16383639|NCT00023998|Biological|filgrastim|Given IV
16383640|NCT00023998|Procedure|therapeutic conventional surgery|Undergo resection
16383641|NCT00023998|Radiation|radiation therapy|Undergo radiotherapy
16383642|NCT00023998|Drug|etoposide|Given IV
16383643|NCT00023998|Drug|ifosfamide|Given IV
16383644|NCT00023998|Biological|trastuzumab|Given IV
16383645|NCT00023998|Other|laboratory biomarker analysis|Correlative studies
16383646|NCT00023985|Biological|autologous tumor cell vaccine|
16383647|NCT00023985|Biological|therapeutic autologous dendritic cells|
16383648|NCT00023985|Procedure|conventional surgery|
16383649|NCT00023972|Drug|exatecan mesylate|
16383650|NCT00023972|Drug|gemcitabine hydrochloride|
16383651|NCT00023959|Drug|hydroxyurea|Given orally
16383652|NCT00023959|Drug|fluorouracil|Given IV
16383653|NCT00023959|Biological|bevacizumab|Given IV
16383654|NCT00023959|Radiation|radiation therapy|Undergo radiotherapy
16383655|NCT00023959|Biological|filgrastim|Given subcutaneously
16383656|NCT00023959|Other|laboratory biomarker analysis|Correlative studies
16383657|NCT00023946|Drug|ixabepilone|Given IV
16383658|NCT00023946|Other|laboratory biomarker analysis|Correlative studies
16383659|NCT00023920|Biological|bevacizumab|Given IV
16383660|NCT00023920|Drug|idarubicin|Given IV
16383661|NCT00023920|Drug|cytarabine|Given SC
16383662|NCT00023894|Drug|alvocidib|
16383663|NCT00023881|Drug|bortezomib|
16383664|NCT00023855|Drug|bortezomib|
16383665|NCT00023855|Drug|doxorubicin hydrochloride|
16383666|NCT00023842|Biological|BCG vaccine|
16383667|NCT00023842|Drug|mitomycin C|
16383668|NCT00023842|Procedure|adjuvant therapy|
16383669|NCT00023842|Procedure|conventional surgery|
16383670|NCT00023829|Drug|bicalutamide|
16383671|NCT00023829|Drug|flutamide|
16383672|NCT00023829|Drug|releasing hormone agonist therapy|
16383673|NCT00023829|Procedure|adjuvant therapy|
16383674|NCT00023829|Radiation|radiation therapy|
16383675|NCT00023790|Drug|silicon phthalocyanine 4|Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Pc 4.
16383676|NCT00023777|Biological|filgrastim|induction: 5 mcg/kg/d IV or SC starting apx day 15
16383677|NCT00023777|Biological|sargramostim|induction: 250 mcg/m2/d IV or SC starting apx day 1
16383678|NCT00023777|Drug|cytarabine|ind: 200 mg/m2/d continuous IV days 1-7 consol: 200 mg/m2/d continuous IV days 1-5
16383679|NCT00023777|Drug|daunorubicin hydrochloride|ind and consol: 45 mg/m2/d continuous IV days 1-3
16383680|NCT00023764|Drug|bortezomib|Given IV
16383681|NCT00023751|Drug|fluorouracil|
16383682|NCT00023751|Drug|leucovorin calcium|
16383683|NCT00023751|Procedure|conventional surgery|
16383684|NCT00023751|Radiation|radiation therapy|
16383685|NCT00023712|Drug|bortezomib|Given IV
16383686|NCT00023712|Other|laboratory biomarker analysis|Correlative studies
16383687|NCT00023712|Other|pharmacological study|Correlative studies
16383688|NCT00023686|Procedure|surgery|
16383689|NCT00023686|Radiation|radiation|
16383690|NCT00023660|Drug|celecoxib|
16383691|NCT00023660|Drug|cisplatin|
16383692|NCT00023660|Drug|fluorouracil|
16383693|NCT00023660|Radiation|brachytherapy|
16383694|NCT00023660|Radiation|radiation therapy|
16383695|NCT00023634|Biological|KLH|100 mcg w/EGFRvIII
16383696|NCT00023634|Biological|GMCSF|arm 1: 100 mcg w/EGFRvIII
16383697|NCT00023621|Drug|celecoxib|
16383698|NCT00022737|Biological|filgrastim|Given SC
16383699|NCT00022737|Drug|asparaginase|Given IM
16383700|NCT00022737|Drug|cyclophosphamide|Given IV
16383701|NCT00022737|Drug|cyclosporine|Given IV
16383702|NCT00022737|Drug|cytarabine|Given IT and IV
16383703|NCT00022737|Drug|daunorubicin hydrochloride|Given IV
16383704|NCT00022737|Drug|dexamethasone|Given orally
16383705|NCT00022737|Drug|etoposide|Given IV
16383706|NCT00022737|Drug|ifosfamide|Given IV
16383707|NCT00022737|Drug|imatinib mesylate|Given orally
16383708|NCT00022737|Drug|leucovorin calcium|Given IV or orally
16383709|NCT00022737|Drug|mercaptopurine tablet|Given orally
16383710|NCT00022737|Drug|methotrexate|Given IT, IV, and orally
16383711|NCT00022737|Drug|pegaspargase|Given IM
16383712|NCT00022737|Drug|vincristine sulfate|Given IV
16383713|NCT00022737|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
16383714|NCT00022737|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
16383715|NCT00022737|Procedure|umbilical cord blood transplantation|Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation
16383716|NCT00022737|Radiation|radiation therapy|Undergo radiation therapy
16383717|NCT00022724|Drug|temsirolimus|
16383718|NCT00022711|Drug|temozolomide|150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months
16383719|NCT00022698|Drug|Capecitabine|
16383720|NCT00022698|Drug|Irinotecan|
16383721|NCT00022685|Biological|epratuzumab|
16383722|NCT00022672|Drug|trastuzumab (Herceptin®)|4mg/kg iv loading dose, followed by 2mg/kg iv weekly
16383723|NCT00022672|Drug|anastrazole (Arimidex®)|1 mg tablet taken orally daily
16383724|NCT00022659|Biological|bevacizumab|Given IV
16383725|NCT00022659|Other|laboratory biomarker analysis|Correlative studies
16383726|NCT00022646|Drug|gemcitabine hydrochloride|
16383727|NCT00022646|Drug|pemetrexed disodium|
16383728|NCT00022633|Drug|gemcitabine hydrochloride|
16383729|NCT00022633|Drug|paclitaxel|
16383730|NCT00022620|Drug|paclitaxel|
16383731|NCT00022607|Biological|bevacizumab|
16383732|NCT00022607|Drug|thalidomide|
16383733|NCT00022581|Drug|thalidomide|Given orally
16383734|NCT00022581|Other|laboratory biomarker analysis|Correlative studies
16383735|NCT00022568|Biological|recombinant vaccinia-TRICOM vaccine|
16383736|NCT00022555|Drug|bryostatin 1|Given IV
16383737|NCT00022555|Drug|vincristine sulfate|Given IV
16383738|NCT00022516|Drug|Cyclophosphamide|50 mg/day orally continuously for 1 year
16383739|NCT00022516|Drug|Methotrexate|2.5 mg twice/day orally days 1 and 2 of every week for 1 year
16383740|NCT00022490|Drug|cytarabine|Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
16383741|NCT00022490|Drug|imatinib mesylate|Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
16383742|NCT00022464|Drug|temsirolimus|
16383743|NCT00022451|Drug|tipifarnib|
16383744|NCT00022438|Biological|aldesleukin|
16383745|NCT00022438|Biological|incomplete Freund's adjuvant|
16383746|NCT00022438|Biological|recombinant tyrosinase-related protein-2|
16383747|NCT00022425|Drug|perillyl alcohol|
16383748|NCT00022412|Dietary Supplement|doxercalciferol|Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
16383749|NCT00022412|Procedure|conventional surgery|Procedure: Prostatectomy for prostate cancer
16383750|NCT00022399|Drug|celecoxib|400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
16383751|NCT00022399|Drug|Placebos|Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
16383752|NCT00022334|Biological|AFP|Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
16383753|NCT00022295|Drug|idronoxil|
16383754|NCT00022230|Biological|aldesleukin|
16383755|NCT00022230|Biological|filgrastim|
16383756|NCT00022230|Biological|sargramostim|
16383757|NCT00022230|Biological|therapeutic autologous lymphocytes|
16383758|NCT00022230|Drug|cyclophosphamide|
16383759|NCT00022230|Drug|doxorubicin hydrochloride|
16383760|NCT00022230|Drug|paclitaxel|
16383761|NCT00022191|Drug|cisplatin|
16383762|NCT00022191|Drug|gemcitabine hydrochloride|
16383763|NCT00022191|Drug|paclitaxel|
16383764|NCT00022152|Drug|vinorelbine tartrate|
16383765|NCT00022126|Drug|asparaginase|
16383766|NCT00022126|Drug|cyclophosphamide|
16383767|NCT00022126|Drug|cyclosporine|
16383768|NCT00022126|Drug|cytarabine|
16383769|NCT00022126|Drug|daunorubicin hydrochloride|
16383770|NCT00022126|Drug|dexamethasone|
16383771|NCT00022126|Drug|doxorubicin hydrochloride|
16383772|NCT00022126|Drug|mercaptopurine|
16383773|NCT00022126|Drug|methotrexate|
16383774|NCT00022126|Drug|methylprednisolone|
16383775|NCT00022126|Drug|pegaspargase|
16383776|NCT00022126|Drug|thioguanine|
16383777|NCT00022126|Drug|vincristine sulfate|
16383778|NCT00022126|Procedure|allogeneic bone marrow transplantation|
16383779|NCT00022126|Radiation|radiation therapy|
16383780|NCT00022113|Drug|cilengitide|Given IV
16383781|NCT00022113|Other|pharmacological study|Correlative studies
16383782|NCT00022113|Other|laboratory biomarker analysis|Correlative studies
16383783|NCT00022087|Dietary Supplement|calcium salts|1000 mg PO per day
16383784|NCT00022087|Dietary Supplement|cholecalciferol|400 IU PO per day
16383785|NCT00022087|Drug|zoledronic acid|4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
16383786|NCT00022074|Drug|gabapentin|
16383787|NCT00022074|Procedure|quality-of-life assessment|
16383788|NCT00022048|Biological|bevacizumab|
16383789|NCT00022035|Biological|trivalent influenza vaccine|
16383790|NCT00022022|Drug|docetaxel|
16383791|NCT00022022|Procedure|quality-of-life assessment|
16383792|NCT00021450|Drug|bicalutamide|
16383793|NCT00021450|Drug|goserelin acetate|
16383794|NCT00021450|Procedure|adjuvant therapy|
16383795|NCT00021450|Radiation|radiation therapy|
16383796|NCT00021424|Biological|recombinant fowlpox-TRICOM vaccine|
16383797|NCT00021320|Drug|cisplatin|
16383798|NCT00021320|Drug|fluorouracil|
16383799|NCT00021320|Drug|paclitaxel|
16383800|NCT00021320|Procedure|conventional surgery|
16383801|NCT00021320|Procedure|neoadjuvant therapy|
16383802|NCT00021320|Radiation|radiation therapy|
16383803|NCT00021255|Drug|Doxorubicin|
16383804|NCT00021255|Drug|Cyclophosphamide|
16383805|NCT00021255|Drug|Docetaxel|
16383806|NCT00021255|Drug|Herceptin|
16383807|NCT00021255|Drug|Carboplatin|
16383808|NCT00021242|Drug|docetaxel|Continuous IV infusion
16383809|NCT00021229|Drug|imatinib mesylate|"Phase 1 Stratum I: Starting dose level of 350 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase I Stratum IIA: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase I Stratum IIB: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)
~Phase II: Phase I Stratum I determined dose (Maximum tolerated dose) every 28 days X 13 courses."
16383810|NCT00021229|Radiation|local irradiation therapy|"Phase I Stratum I: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib.
~Phase II: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib."
16383811|NCT00021216|Drug|bortezomib|Given IV
16383812|NCT00021216|Other|laboratory biomarker analysis|Correlative studies
16383813|NCT00021216|Other|pharmacological study|Correlative studies
16383814|NCT00021164|Biological|aldesleukin|
16383815|NCT00021164|Biological|incomplete Freund's adjuvant|
16383816|NCT00021164|Biological|telomerase: 540-548 peptide vaccine|
16383817|NCT00021125|Procedure|adjuvant therapy|
16383818|NCT00021125|Radiation|radiation therapy|
16383819|NCT00021112|Drug|cisplatin|
16383820|NCT00021112|Drug|etoposide|
16383821|NCT00021112|Procedure|conventional surgery|
16383822|NCT00021112|Radiation|radiation therapy|
16383823|NCT00021073|Drug|alvocidib|Given IV
16383824|NCT00021073|Drug|leucovorin calcium|Given IV
16383825|NCT00021073|Drug|fluorouracil|Given IV
16383826|NCT00021073|Drug|irinotecan hydrochloride|Given IV
16383827|NCT00021060|Drug|paclitaxel|Given IV
16383828|NCT00021060|Drug|carboplatin|Given IV
16383829|NCT00021060|Biological|bevacizumab|Given IV
16383830|NCT00021060|Other|laboratory biomarker analysis|Correlative studies
16383831|NCT00021047|Drug|capecitabine|
16383832|NCT00021047|Drug|carboplatin|
16383833|NCT00021047|Drug|epirubicin hydrochloride|
16383834|NCT00020995|Procedure|therapeutic dietary intervention|
16383835|NCT00020969|Drug|arsenic trioxide|
16383836|NCT00020943|Biological|filgrastim|5 ug/kg subQ daily day 4 until ANC >10,000 (or ANC> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3
16383837|NCT00020943|Biological|rituximab|375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 & 12 Tx 3, and weekly for 2 doses Tx 5
16383838|NCT00020943|Drug|carmustine|15 mg/kg IV infusion over 2 hours Day 6, Tx 4
16383839|NCT00020943|Drug|cyclophosphamide|2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 & 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4
16383840|NCT00020943|Drug|cytarabine|2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
16383841|NCT00020943|Drug|doxorubicin hydrochloride|50 mg/sq m IVP Day 3, Tx 1& 2
16383842|NCT00020943|Drug|etoposide|40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
16383843|NCT00020943|Drug|leucovorin calcium|50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels <0.05 uM, Tx 1 & 2
16383844|NCT00020943|Drug|methotrexate|300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 & 2
16383845|NCT00020943|Drug|prednisone|100 mg/sq m PO Days 3-7, Tx 1 & 2
16383846|NCT00020943|Drug|vincristine sulfate|1.4 mg/sq m IVP Day 3, Tx 1 & 2
16383847|NCT00020943|Procedure|peripheral blood stem cell transplantation|Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4
16383848|NCT00020891|Procedure|computed tomography|
16383849|NCT00020891|Radiation|radiation therapy|
16383850|NCT00020878|Drug|celecoxib|Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
16383851|NCT00020852|Procedure|conventional surgery|
16383852|NCT00020852|Procedure|cryosurgery|
16383853|NCT00020839|Drug|temozolomide|
16383854|NCT00020839|Radiation|radiation therapy|
16383855|NCT00020826|Other|quality-of-life assessment|QLQ-C30 questionnaire administered. STO22 questionnaire administered.
16383856|NCT00020800|Biological|rituximab|
16383857|NCT00020800|Drug|fludarabine phosphate|
16383858|NCT00020761|Drug|irinotecan hydrochloride|"The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
~Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks."
16383859|NCT00020761|Drug|paclitaxel|"The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
~Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks."
16383860|NCT00020748|Drug|epirubicin hydrochloride|
16383861|NCT00020748|Drug|irinotecan hydrochloride|
16383862|NCT00020735|Drug|toremifene|
16383863|NCT00020735|Procedure|conventional surgery|
16383864|NCT00020735|Procedure|neoadjuvant therapy|
16383865|NCT00020722|Biological|therapeutic autologous lymphocytes|"Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.
~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion."
16383947|NCT00019994|Biological|MART-1 antigen|
16383948|NCT00019994|Biological|aldesleukin|
16383949|NCT00019994|Biological|gp100 antigen|
16383950|NCT00019994|Biological|incomplete Freund's adjuvant|
16383866|NCT00020722|Drug|Ifosfamide, carboplatin, and etoposide (ICE) regimen|"Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.
~Carboplatin at a dose of 250 mg/m2 will be given daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 1500 mg/m2.
~VP-16 (etoposide) at a dose of 200 mg/m2 will be given IV on days -8, -7, -6, -5, -4 and -3. The total dose of VP-16 given prior to PBSCT will be 2,400 mg/m2. VP-16 will be given 200 mg/m2"
16383867|NCT00020722|Drug|Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC)|"Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -4, -3, and -2 (total = 6000 mg/m2).
~Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -4, -3, -2 (total = 500 mg/m2) as the preparative regimen followed by PBSCT on day 0.
~Carboplatin will be given at a dose of 267 mg/m2 in D5W IV over one hour daily on days -4, -3, and -2.
~Mesna will be administered per BMT Standard of Care Guidelines at a dose of 25% of the total cyclophosphamide dose 30 minutes prior to and then 3, 6, and 9 hours after cyclophosphamide daily on days -4, -3, and -2 prior to PBSCT for a total of 2000mg/m2."
16383868|NCT00020722|Procedure|Leukapheresis|Peripheral blood mononuclear cells (PBMC) will be collected by leukapheresis (for generation of ATC) prior to or post G-CSF (16 ug/kg/day) priming for collecting stem cells.
16383869|NCT00020722|Procedure|peripheral blood stem cell transplantation (PBSCT)|Will be collected either before or after peripheral blood stem cell collection for stem cell transplant.
16383870|NCT00020709|Drug|cisplatin|Given IV
16383871|NCT00020709|Drug|docetaxel|Given IV
16383872|NCT00020709|Drug|etoposide|Given IV
16383873|NCT00020709|Drug|gefitinib|Given orally
16383874|NCT00020709|Radiation|radiation therapy|Undergo radiation therapy
16383875|NCT00020709|Other|placebo|Given orally
16383876|NCT00020683|Drug|incyclinide|High dose given orally
16383877|NCT00020683|Drug|incyclinide|Low dose given orally
16383878|NCT00020683|Other|laboratory biomarker analysis|Correlative studies
16383879|NCT00020670|Biological|CD 40|
16383880|NCT00020657|Drug|dolasetron mesylate|
16383881|NCT00020657|Drug|granisetron hydrochloride|
16383882|NCT00020657|Drug|ondansetron|
16383883|NCT00020657|Drug|prochlorperazine|
16383884|NCT00020657|Procedure|quality-of-life assessment|
16383885|NCT00020644|Drug|gemcitabine hydrochloride|
16383886|NCT00020631|Drug|pirfenidone|
16383887|NCT00020579|Drug|entinostat|
16383888|NCT00020566|Biological|dactinomycin|Given IV
16383889|NCT00020566|Drug|busulfan|Given orally and IV
16383890|NCT00020566|Drug|doxorubicin hydrochloride|Given IV
16383891|NCT00020566|Drug|etoposide|Given IV
16383892|NCT00020566|Drug|ifosfamide|Given IV
16383893|NCT00020566|Drug|melphalan|Given orally and IV
16383894|NCT00020566|Drug|vincristine sulfate|Given IV
16383895|NCT00020566|Procedure|autologous hematopoietic stem cell transplantation|Given IV
16383896|NCT00020566|Procedure|conventional surgery|Given to patients deemed to require it
16383897|NCT00020566|Radiation|radiation therapy|Given to patients deemed to require it
16383898|NCT00020527|Drug|caspofungin acetate|
16383899|NCT00020501|Drug|FOLFIRI regimen|
16383900|NCT00020501|Drug|floxuridine|
16383901|NCT00020501|Drug|fluorouracil|
16383902|NCT00020501|Drug|irinotecan hydrochloride|
16383903|NCT00020501|Drug|leucovorin calcium|
16383904|NCT00020501|Drug|melphalan|
16383905|NCT00020501|Procedure|hyperthermia treatment|
16383906|NCT00020488|Drug|FOLFIRI regimen|
16383907|NCT00020488|Drug|fluorouracil|
16383908|NCT00020488|Drug|irinotecan hydrochloride|
16383909|NCT00020488|Drug|leucovorin calcium|
16383910|NCT00020449|Biological|recombinant interleukin-12|
16383911|NCT00020449|Drug|paclitaxel|
16383912|NCT00020449|Drug|pegylated liposomal doxorubicin hydrochloride|
16383913|NCT00020410|Biological|filgrastim|
16383914|NCT00020410|Procedure|peripheral blood stem cell transplantation|
16383915|NCT00020410|Radiation|yttrium Y 90 monoclonal antibody B3|
16383916|NCT00020397|Biological|NY-ESO-1 peptide vaccine|
16383917|NCT00020397|Biological|aldesleukin|
16383918|NCT00020358|Biological|aldesleukin|
16383919|NCT00020358|Biological|gp100 antigen|
16383920|NCT00020358|Biological|incomplete Freund's adjuvant|
16383921|NCT00020358|Biological|tyrosinase peptide|
16383922|NCT00020332|Drug|alvocidib|
16383923|NCT00020332|Drug|docetaxel|
16383924|NCT00020254|Biological|aldesleukin|
16383925|NCT00020254|Biological|recombinant fowlpox-prostate specific antigen vaccine|
16383926|NCT00020254|Biological|recombinant vaccinia prostate-specific antigen vaccine|
16383927|NCT00020254|Biological|recombinant vaccinia-B7.1 vaccine|
16383928|NCT00020254|Biological|sargramostim|
16383929|NCT00020254|Drug|nilutamide|
16383930|NCT00020189|Drug|acetylsalicylic acid|
16383931|NCT00020189|Drug|alvocidib|
16383932|NCT00020189|Drug|clopidogrel bisulfate|
16383933|NCT00020176|Biological|filgrastim|
16383934|NCT00020176|Biological|therapeutic allogeneic lymphocytes|
16383935|NCT00020176|Drug|cyclophosphamide|
16383936|NCT00020176|Drug|cyclosporine|
16383937|NCT00020176|Drug|fludarabine phosphate|
16383938|NCT00020176|Procedure|peripheral blood stem cell transplantation|
16383939|NCT00020150|Drug|O6-benzylguanine|
16383940|NCT00020150|Drug|temozolomide|
16383941|NCT00020124|Drug|doxorubicin hydrochloride|
16383942|NCT00020111|Drug|arsenic trioxide|
16383943|NCT00020072|Other|laboratory biomarker analysis|
16383944|NCT00020007|Drug|isolated perfusion|
16383945|NCT00020007|Drug|paclitaxel|
16383946|NCT00020007|Procedure|hyperthermia treatment|
16383951|NCT00019955|Procedure|laparoscopic surgery|
16383952|NCT00019955|Procedure|radiofrequency ablation|
16383953|NCT00019955|Procedure|thermal ablation therapy|
16383954|NCT00019929|Biological|mutant p53 peptide pulsed dendritic cell vaccine|
16383955|NCT00019929|Procedure|adjuvant therapy|
16383956|NCT00019916|Biological|aldesleukin|
16383957|NCT00019916|Biological|p53 peptide vaccine|
16383958|NCT00019916|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16383959|NCT00019864|Biological|filgrastim|
16383960|NCT00019864|Drug|cisplatin|
16383961|NCT00019864|Drug|dexrazoxane hydrochloride|
16383962|NCT00019864|Drug|doxorubicin hydrochloride|
16383963|NCT00019864|Drug|leucovorin calcium|
16383964|NCT00019864|Drug|methotrexate|
16383965|NCT00019864|Procedure|adjuvant therapy|
16383966|NCT00019864|Procedure|conventional surgery|
16383967|NCT00019864|Procedure|neoadjuvant therapy|
16383968|NCT00019838|Drug|7-hydroxystaurosporine|
16383969|NCT00019838|Drug|fludarabine phosphate|
16383970|NCT00019825|Drug|decitabine|
16383971|NCT00019812|Biological|trastuzumab|
16383972|NCT00019812|Drug|paclitaxel|
16383973|NCT00019786|Drug|isolated perfusion|
16383974|NCT00019786|Drug|melphalan|
16383975|NCT00019786|Procedure|conventional surgery|
16383976|NCT00019773|Drug|capecitabine|
16383977|NCT00019773|Drug|oxaliplatin|
16383978|NCT00019747|Drug|thalidomide|oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
16383979|NCT00019747|Procedure|adjuvant therapy|Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs.
16383980|NCT00019747|Other|Placebo|oral placebo once daily
16383981|NCT00019708|Drug|tanespimycin|Given IV
16383982|NCT00019682|Biological|Aldesleukin|Given IV
16383983|NCT00019682|Biological|gp100 Antigen|Given SC
16383984|NCT00019682|Drug|Montanide ISA 51 VG|Given SC
16383985|NCT00019682|Other|Quality-of-Life Assessment|Ancillary studies
16383986|NCT00019682|Other|Questionnaire Administration|Ancillary studies
16383987|NCT00019682|Other|Laboratory Biomarker Analysis|Correlative studies
16383988|NCT00019669|Biological|aldesleukin|
16383989|NCT00019669|Biological|fowlpox virus vaccine vector|
16383990|NCT00019669|Biological|gp100 antigen|
16383991|NCT00019656|Drug|perifosine|
16383992|NCT00019604|Procedure|computed tomography|Scan to assess the effects of ablation.
16383993|NCT00019604|Procedure|magnetic resonance imaging|Imaging used to assess the effects of this ablative therapy on tumor vascular density.
16383994|NCT00019604|Procedure|positron emission tomography|Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
16383995|NCT00019604|Procedure|radiofrequency ablation|Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.
16383996|NCT00019604|Procedure|radionuclide imaging|Imaging following injection of a radioactive material.
16383997|NCT00019604|Procedure|ultrasound imaging|An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.
16383998|NCT00019604|Radiation|fludeoxyglucose F 18 (FDG-PET)|FDG PET scans rely on metabolic changes to evaluate response to therapy.
16383999|NCT00019604|Radiation|gadopentetate dimeglumine|Food and Drug Administration approved contrast agent.
16384000|NCT00019591|Biological|aldesleukin|
16384001|NCT00019591|Biological|ras peptide cancer vaccine|
16384002|NCT00019591|Procedure|adjuvant therapy|
16384003|NCT00019565|Procedure|magnetic resonance imaging|
16384004|NCT00019565|Procedure|positron emission tomography|
16384005|NCT00019565|Radiation|fludeoxyglucose F 18|
16384006|NCT00019513|Drug|fluorouracil|
16384007|NCT00019513|Drug|gemcitabine hydrochloride|
16384008|NCT00019513|Drug|leucovorin calcium|
16384009|NCT00019487|Biological|aldesleukin|
16384010|NCT00019487|Biological|gp209-2M antigen|
16384011|NCT00019487|Biological|incomplete Freund's adjuvant|
16384012|NCT00019461|Drug|carboxyamidotriazole|
16384013|NCT00019461|Drug|chemotherapy|
16384014|NCT00019422|Drug|carboplatin|
16384015|NCT00019422|Drug|lobradimil|
16384016|NCT00019331|Biological|aldesleukin|
16384017|NCT00019331|Biological|ras peptide cancer vaccine|
16384018|NCT00019331|Biological|sargramostim|
16384019|NCT00019331|Drug|DetoxPC|
16384020|NCT00019227|Drug|pentetic acid calcium|
16384021|NCT00019227|Radiation|yttrium Y 90 daclizumab|
16384022|NCT00019214|Biological|MART-1 antigen|
16384023|NCT00019214|Biological|aldesleukin|
16384024|NCT00019214|Biological|gp100 antigen|
16384025|NCT00019201|Other|cytology specimen collection procedure|
16384026|NCT00019201|Other|immunohistochemistry staining method|
16384027|NCT00019201|Other|sputum cytology|
16384028|NCT00019201|Procedure|bronchoscopic and lung imaging studies|
16384029|NCT00019201|Procedure|bronchoscopy|
16384030|NCT00019201|Procedure|comparison of screening methods|
16384031|NCT00019201|Procedure|endoscopic biopsy|
16384032|NCT00019136|Biological|MOv-gamma chimeric receptor gene|
16384033|NCT00019136|Biological|aldesleukin|
16384034|NCT00019136|Biological|therapeutic allogeneic lymphocytes|
16384035|NCT00019110|Biological|human papillomavirus 16 E7 peptide|
16384036|NCT00019110|Biological|synthetic human papillomavirus 16 E6 peptide|
16384037|NCT00019032|Biological|monoclonal antibody Mik-beta-1|
16384038|NCT00019019|Drug|carboxyamidotriazole|
16384039|NCT00019019|Drug|paclitaxel|
16384040|NCT00018967|Drug|glucarpidase|
16384041|NCT00017602|Biological|oblimersen sodium|
16384042|NCT00017602|Drug|dexamethasone|
16384043|NCT00017589|Biological|oblimersen sodium|
16384044|NCT00017589|Drug|gemtuzumab ozogamicin|
16384045|NCT00017563|Drug|docetaxel|35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
16384046|NCT00017563|Drug|mitoxantrone hydrochloride|Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
16384047|NCT00017563|Procedure|conventional surgery|Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
16384048|NCT00017550|Biological|anti-thymocyte globulin|
16384049|NCT00017524|Drug|pelitrexol|
16384050|NCT00017511|Drug|cevimeline hydrochloride|
16384051|NCT00017498|Drug|gemcitabine hydrochloride|
16384052|NCT00017485|Drug|HPPH|
16384053|NCT00017472|Biological|apolizumab|Given IV
16384054|NCT00017472|Other|laboratory biomarker analysis|Correlative studies
16384055|NCT00017472|Other|pharmacological study|Correlative studies
16384056|NCT00017381|Biological|rituximab|Given IV
16384057|NCT00017381|Drug|cyclophosphamide|Given IV
16384058|NCT00017381|Biological|filgrastim|Given SC
16384059|NCT00017381|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16384060|NCT00017381|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16384061|NCT00017355|Biological|filgrastim|
16384062|NCT00017355|Biological|therapeutic autologous dendritic cells|
16384063|NCT00017329|Drug|bortezomib|
16384064|NCT00017290|Biological|autologous immunoglobulin idiotype-KLH conjugate vaccine|
16384065|NCT00017290|Biological|keyhole limpet hemocyanin|
16384066|NCT00017290|Biological|sargramostim|
16384067|NCT00017290|Drug|cyclophosphamide|
16384068|NCT00017290|Drug|prednisone|
16384069|NCT00017290|Drug|vincristine sulfate|
16384070|NCT00017277|Biological|epoetin alfa|
16384071|NCT00017277|Radiation|radiation therapy|
16384072|NCT00017264|Drug|atrasentan hydrochloride|
16384073|NCT00017251|Biological|oblimersen sodium|Given IV
16384074|NCT00017251|Drug|carboplatin|Given IV
16384075|NCT00017251|Drug|etoposide|Given IV
16384076|NCT00017251|Other|pharmacological study|Correlative studies
16384077|NCT00017251|Other|laboratory biomarker analysis|Correlative studies
16384078|NCT00017238|Drug|KRN5500|Given IV
16384079|NCT00017238|Other|pharmacological study|Correlative studies
16384080|NCT00017225|Biological|filgrastim|
16384081|NCT00017225|Drug|carboplatin|
16384082|NCT00017225|Drug|cisplatin|
16384083|NCT00017225|Drug|cyclophosphamide|
16384084|NCT00017225|Drug|dacarbazine|
16384085|NCT00017225|Drug|doxorubicin hydrochloride|
16384086|NCT00017225|Drug|etoposide|
16384087|NCT00017225|Drug|ifosfamide|
16384088|NCT00017225|Drug|melphalan|
16384089|NCT00017225|Drug|tretinoin|
16384090|NCT00017225|Drug|vincristine sulfate|
16384091|NCT00017225|Drug|vindesine|
16384092|NCT00017225|Procedure|autologous bone marrow transplantation|
16384093|NCT00017225|Procedure|conventional surgery|
16384094|NCT00017225|Procedure|peripheral blood stem cell transplantation|
16384095|NCT00017225|Radiation|radiation therapy|
16384096|NCT00017212|Drug|exatecan mesylate|
16384097|NCT00017186|Drug|epirubicin hydrochloride|
16384098|NCT00017186|Drug|gemcitabine hydrochloride|
16384099|NCT00017173|Biological|Ad5CMV-p53 gene|2 intraoperative and one post-operative injection of Ad5CMV-p53.
16384100|NCT00017173|Drug|cisplatin|100 mg/m2 IV Day 1 every 21 days for 3 cycles
16384101|NCT00017173|Procedure|conventional surgery|conventional surgery
16384102|NCT00017173|Radiation|radiation therapy|200 cGy per day Days 105 every week for 6 weeks
16384103|NCT00017160|Drug|doxorubicin|
16384104|NCT00017160|Drug|filgrastim|
16384105|NCT00017160|Drug|ifosfamide|
16384106|NCT00017160|Procedure|biological response modifier therapy|
16384107|NCT00017160|Procedure|brachytherapy|
16384108|NCT00017160|Procedure|chemotherapy|
16384109|NCT00017160|Procedure|colony-stimulating factor therapy|
16384110|NCT00017160|Procedure|conventional surgery|
16384111|NCT00017160|Procedure|cytokine therapy|
16384112|NCT00017160|Procedure|intraoperative radiotherapy|
16384113|NCT00017160|Procedure|radiation therapy|
16384114|NCT00017160|Procedure|surgery|
16384115|NCT00017147|Drug|carmustine|"40 mg/m^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.
~200 mg/m^2 IV over 1 hour on day 2 of each cycle for the active comparator arm."
16384116|NCT00017147|Radiation|radiation therapy|5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
16384117|NCT00017147|Drug|O6-Benzylguanine|120 mg/m^2 IV over 1 hour on day 1 of each cycle
16384118|NCT00017121|Biological|sargramostim|
16384119|NCT00017108|Drug|chlorambucil|
16384120|NCT00017108|Drug|cyclophosphamide|
16384121|NCT00017108|Drug|fludarabine phosphate|
16384122|NCT00017095|Biological|filgrastim|
16384123|NCT00017095|Drug|cyclophosphamide|
16384124|NCT00017095|Drug|docetaxel|
16384125|NCT00017095|Drug|epirubicin hydrochloride|
16384126|NCT00017095|Drug|fluorouracil|
16384127|NCT00017095|Genetic|microarray analysis|
16384128|NCT00017095|Other|immunohistochemistry staining method|
16384129|NCT00017095|Other|laboratory biomarker analysis|
16384130|NCT00017095|Procedure|biopsy|
16384131|NCT00017095|Procedure|conventional surgery|
16384132|NCT00017095|Procedure|neoadjuvant therapy|
16384133|NCT00017095|Radiation|radiation therapy|
16384134|NCT00017069|Drug|arsenic trioxide|
16384135|NCT00017069|Drug|dexamethasone|
16384136|NCT00017004|Radiation|External Beam Radiation Therapy|Undergo radiation
16384137|NCT00017004|Drug|Cisplatin|Given IV
16384138|NCT00017004|Radiation|Internal Radiation Therapy|Undergo radiation
16384139|NCT00017004|Biological|Epoetin Alfa|Given SC
16384140|NCT00016991|Drug|gefitinib|
16384141|NCT00016965|Drug|ixabepilone|
16384142|NCT00016952|Drug|fluorouracil|
16384143|NCT00016952|Drug|irinotecan hydrochloride|
16384144|NCT00016952|Drug|leucovorin calcium|
16384145|NCT00016926|Drug|capecitabine|
16384146|NCT00016913|Drug|carboplatin|AUC=6 week one of each 4 week cycle
16384147|NCT00016913|Drug|estramustine|2 tablets tid PO 5 of 7 days per week each 4 week cycle
16384148|NCT00016913|Drug|paclitaxel|80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
16384149|NCT00016913|Radiation|radiation therapy|77.4 Gy in 1.8 Gy fractions
16384150|NCT00016913|Drug|leuprolide or goserelin acetate|7.5 mg IM injection once every 4 weeks for 6 months
16384151|NCT00016887|Biological|filgrastim|
16384152|NCT00016887|Biological|recombinant interferon alfa|
16384153|NCT00016887|Drug|carmustine|
16384154|NCT00016887|Drug|cyclophosphamide|
16384155|NCT00016887|Drug|cytarabine|
16384156|NCT00016887|Drug|dexamethasone|
16384157|NCT00016887|Drug|etoposide|
16384158|NCT00016887|Drug|melphalan|
16384159|NCT00016887|Procedure|bone marrow ablation with stem cell support|
16384160|NCT00016887|Procedure|peripheral blood stem cell transplantation|
16384161|NCT00016887|Radiation|radiation therapy|
16384162|NCT00016861|Drug|irinotecan hydrochloride|
16384163|NCT00016432|Drug|exemestane|25 mg for 5 years
16384164|NCT00016432|Drug|Placebo|Placebo
16384165|NCT00016419|Biological|anti-thymocyte globulin|3.5 mg/kg/d IV over 12 hrs day 1
16384166|NCT00016419|Drug|cyclosporine|3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
16384167|NCT00016406|Biological|filgrastim|
16384168|NCT00016406|Drug|cyclophosphamide|
16384169|NCT00016406|Drug|doxorubicin|
16384170|NCT00016406|Drug|paclitaxel|
16384171|NCT00016406|Procedure|surgery|
16384172|NCT00016393|Drug|ixabepilone|
16384173|NCT00016380|Drug|dexamethasone|
16384174|NCT00016380|Drug|ondansetron|
16384175|NCT00016380|Procedure|quality-of-life assessment|
16384176|NCT00016354|Drug|benzoylphenylurea|
16384177|NCT00016328|Drug|temsirolimus|Given IV
16384178|NCT00016328|Other|laboratory biomarker analysis|Correlative studies
16384179|NCT00016328|Other|pharmacological study|Correlative studies
16384180|NCT00016302|Drug|prednisone|Given orally
16384181|NCT00016302|Drug|vincristine sulfate|Given IV
16384182|NCT00016302|Drug|daunorubicin hydrochloride|Given IV
16384183|NCT00016302|Drug|asparaginase|Given IM
16384184|NCT00016302|Drug|methotrexate|Given IT and orally
16384185|NCT00016302|Drug|cyclophosphamide|Given IV
16384186|NCT00016302|Drug|cytarabine|Given IV or SC
16384187|NCT00016302|Drug|mercaptopurine|Given orally
16384188|NCT00016302|Drug|leucovorin calcium|Given IV or orally
16384189|NCT00016302|Drug|dexamethasone|Given orally
16384190|NCT00016302|Drug|doxorubicin hydrochloride|Given IV
16384191|NCT00016302|Drug|thioguanine|Given orally
16384192|NCT00016302|Radiation|radiation therapy|Undergo cranial irradiation
16384193|NCT00016302|Drug|nelarabine|Given IV
16384194|NCT00016302|Drug|pegaspargase|Given IM
16384195|NCT00016302|Radiation|radiation therapy|Undergo craniocervical radiotherapy
16384196|NCT00016302|Other|pharmacological study|Correlative studies
16384197|NCT00016302|Other|laboratory biomarker analysis|Correlative studies
16384198|NCT00016289|Biological|recombinant interleukin-12|Given intraperitoneally
16384199|NCT00016263|Biological|oblimersen sodium|
16384200|NCT00016263|Drug|dacarbazine|
16384201|NCT00016224|Drug|thalidomide|
16384202|NCT00016211|Radiation|radiation therapy|
16384203|NCT00016185|Drug|alvocidib|
16384204|NCT00016185|Drug|docetaxel|
16384205|NCT00016159|Biological|filgrastim|
16384206|NCT00016159|Biological|lintuzumab|
16384207|NCT00016159|Drug|arsenic trioxide|
16384208|NCT00016159|Drug|idarubicin|
16384209|NCT00016159|Drug|tretinoin|
16384210|NCT00016146|Biological|GPI-0100|
16384211|NCT00016146|Biological|MUC-2-Globo H-KLH conjugate vaccine|
16384212|NCT00016133|Biological|BCG vaccine|
16384213|NCT00016133|Biological|autologous tumor cell vaccine|
16384214|NCT00016133|Drug|fluorouracil|
16384215|NCT00016133|Drug|leucovorin calcium|
16384216|NCT00016133|Procedure|adjuvant therapy|
16384217|NCT00016094|Biological|bevacizumab|Given IV
16384218|NCT00016094|Other|laboratory biomarker analysis|Correlative studies
16384219|NCT00016081|Drug|ribavirin|
16384220|NCT00016068|Drug|ganciclovir|
16384221|NCT00016068|Drug|valganciclovir|
16384222|NCT00016055|Biological|lymphokine-activated killer cells|
16384223|NCT00016055|Drug|temozolomide|
16384224|NCT00016029|Other|screening questionnaire administration|
16384225|NCT00016029|Procedure|barium enema injection|
16384226|NCT00016029|Procedure|computed tomography|
16384227|NCT00016029|Procedure|computed tomography colonography|
16384228|NCT00016029|Procedure|diagnostic colonoscopy|
16384229|NCT00016029|Procedure|screening colonoscopy|
16384230|NCT00016016|Drug|cytarabine|Given IV
16384231|NCT00016016|Drug|mitoxantrone hydrochloride|Given IV
16384232|NCT00016016|Drug|alvocidib|Given IV
16384233|NCT00016016|Other|pharmacological study|Correlative studies
16384234|NCT00016016|Other|laboratory procedure|Correlative studies
16384235|NCT00015977|Biological|PSA prostate cancer vaccine|
16384236|NCT00015977|Biological|recombinant interleukin-12|
16384237|NCT00015951|Biological|bevacizumab|
16384238|NCT00015951|Drug|cytarabine|
16384239|NCT00015951|Drug|mitoxantrone hydrochloride|
16384240|NCT00015938|Biological|filgrastim|
16384241|NCT00015938|Drug|docetaxel|
16384242|NCT00015938|Drug|vinorelbine|
16384243|NCT00015925|Drug|entinostat|
16384244|NCT00015899|Drug|lonafarnib|
16384245|NCT00015873|Drug|asparaginase|
16384246|NCT00015873|Drug|cytarabine|
16384247|NCT00015873|Drug|mercaptopurine|
16384248|NCT00015873|Drug|methotrexate|
16384249|NCT00015873|Drug|prednisolone|
16384250|NCT00015873|Drug|vincristine sulfate|
16384251|NCT00015860|Drug|daunorubicin hydrochloride|
16384252|NCT00015860|Drug|imatinib mesylate|
16384253|NCT00015860|Drug|prednisone|
16384254|NCT00015860|Drug|vincristine sulfate|
16384255|NCT00015847|Biological|recombinant interferon alfa|IFN-α will be given at a dose ranging up to 5 MIU daily via subcutaneous injection.
16384256|NCT00015847|Drug|imatinib mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
16384257|NCT00015834|Drug|imatinib mesylate|Given PO
16384258|NCT00015834|Drug|cytarabine|Given IV
16384259|NCT00014612|Procedure|axillary lymph node dissection|
16384260|NCT00014612|Procedure|lymphoscintigraphy|
16384261|NCT00014612|Procedure|therapeutic conventional surgery|
16384262|NCT00014612|Radiation|radiation therapy|
16384263|NCT00014599|Drug|paclitaxel|
16384264|NCT00014586|Drug|bicalutamide|
16384265|NCT00014586|Drug|goserelin acetate|
16384266|NCT00014586|Procedure|orchiectomy|
16384267|NCT00014521|Drug|karenitecin|
16384268|NCT00014508|Biological|sargramostim|
16384269|NCT00014508|Drug|cyclophosphamide|
16384270|NCT00014508|Drug|cyclosporine|
16384271|NCT00014508|Drug|fludarabine phosphate|
16384272|NCT00014508|Drug|melphalan|
16384273|NCT00014508|Procedure|peripheral blood stem cell transplantation|
16384274|NCT00014495|Biological|filgrastim|
16384275|NCT00014495|Drug|cytarabine|
16384276|NCT00014495|Radiation|bismuth Bi213 monoclonal antibody M195|
16384277|NCT00014482|Procedure|pain therapy|
16384278|NCT00014482|Procedure|psychosocial assessment and care|
16384279|NCT00014469|Drug|busulfan|
16384280|NCT00014469|Drug|melphalan|
16384281|NCT00014469|Drug|methotrexate|
16384282|NCT00014469|Drug|tacrolimus|
16384283|NCT00014469|Procedure|allogeneic bone marrow transplantation|
16384284|NCT00014456|Biological|filgrastim|
16384285|NCT00014456|Drug|docetaxel|
16384286|NCT00014456|Drug|gemcitabine hydrochloride|
16384287|NCT00014443|Drug|thalidomide|
16384288|NCT00014443|Drug|topotecan hydrochloride|
16384289|NCT00014378|Drug|Chinese Herb Huanglian (Coptis chinesis)|Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).
16384290|NCT00014326|Radiation|radiation therapy|
16384291|NCT00014313|Drug|cisplatin|
16384292|NCT00014313|Drug|etoposide|
16384293|NCT00014274|Drug|carboplatin|
16384294|NCT00014274|Drug|gemcitabine hydrochloride|
16384295|NCT00014274|Drug|methotrexate|
16384296|NCT00014274|Drug|vinblastine sulfate|
16384297|NCT00014235|Drug|fludarabine phosphate|Given IV
16384298|NCT00014235|Radiation|total-body irradiation|Undergo TBI
16384299|NCT00014235|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16384300|NCT00014235|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo PBSCT
16384301|NCT00014235|Drug|cyclosporine|Given PO or IV
16384302|NCT00014235|Drug|mycophenolate mofetil|Given IV or PO
16384303|NCT00014235|Other|laboratory biomarker analysis|Correlative studies
16384304|NCT00014222|Biological|epoetin alfa|40,000 IU
16384305|NCT00014222|Biological|filgrastim|5 mg/kg/d - days 2-13
16384306|NCT00014222|Drug|cyclophosphamide|75, 600 and 830 mg/m2
16384307|NCT00014222|Drug|doxorubicin hydrochloride|60 mg/m2
16384308|NCT00014222|Drug|epirubicin hydrochloride|60 mg/m2
16384309|NCT00014222|Drug|fluorouracil|500mg/m2
16384310|NCT00014222|Drug|paclitaxel|175 mg/m2
16384311|NCT00014196|Drug|cisplatin|
16384312|NCT00014196|Drug|docetaxel|
16384313|NCT00014196|Radiation|radiation therapy|
16384314|NCT00014131|Biological|Biological/Vaccine: therapeutic autologous dendritic cells.|Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
16384315|NCT00014118|Drug|carboplatin|
16384316|NCT00014118|Drug|paclitaxel|
16384317|NCT00014118|Procedure|conventional surgery|
16384318|NCT00014118|Radiation|radiation therapy|
16384319|NCT00014092|Biological|aldesleukin|
16384320|NCT00014092|Biological|recombinant interferon alfa|
16384321|NCT00014092|Biological|sargramostim|
16384322|NCT00014092|Drug|temozolomide|
16384323|NCT00014079|Genetic|DNA stability analysis|
16384324|NCT00014079|Genetic|loss of heterozygosity analysis|
16384325|NCT00014079|Genetic|microsatellite instability analysis|
16384326|NCT00012389|Drug|irinotecan hydrochloride|
16384327|NCT00012389|Drug|oxaliplatin|
16384328|NCT00012376|Drug|bryostatin 1|Given IV
16384329|NCT00012376|Biological|sargramostim|Given subcutaneously
16384330|NCT00012376|Other|laboratory biomarker analysis|Correlative studies
16384331|NCT00012376|Other|pharmacological study|Correlative studies
16384332|NCT00012363|Drug|gemcitabine hydrochloride|1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
16384333|NCT00012363|Drug|irinotecan hydrochloride|100 mg/m2, IV over 90 min, days 1 & 8, q 21days
16384334|NCT00012324|Drug|doxorubicin hydrochloride|
16384335|NCT00012324|Drug|nolatrexed dihydrochloride|
16384336|NCT00012298|Biological|rituximab|Given IV
16384337|NCT00012298|Biological|yttrium Y 90 ibritumomab tiuxetan|Given IV
16384338|NCT00012298|Biological|indium In 111 ibritumomab tiuxetan|Given IV
16384339|NCT00012298|Biological|oprelvekin|Given subcutaneously
16384340|NCT00012298|Biological|filgrastim|Given subcutaneously
16384341|NCT00012246|Biological|carcinoembryonic antigen peptide 1-6D|
16384342|NCT00012246|Biological|incomplete Freund's adjuvant|
16384343|NCT00012246|Biological|sargramostim|
16384344|NCT00012220|Drug|cisplatin|50 mg/sq m IV infusion over 30 min on Days 1 & 15 of ea cycle
16384345|NCT00012220|Drug|docetaxel|40 mg/sq m IV infusion over 60 min on Days 1 & 8 of ea treatment cycle
16384346|NCT00012220|Drug|gemcitabine hydrochloride|"Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle
~cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
~docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle"
16384347|NCT00012220|Drug|irinotecan hydrochloride|100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle
16384348|NCT00012207|Biological|aldesleukin|
16384349|NCT00012207|Biological|therapeutic autologous lymphocytes|
16384350|NCT00012207|Drug|cyclophosphamide|
16384351|NCT00012207|Drug|prednisone|
16384352|NCT00012207|Drug|vincristine sulfate|
16384353|NCT00012207|Procedure|adjuvant therapy|
16384354|NCT00012194|Drug|7-hydroxystaurosporine|Given IV
16384355|NCT00012194|Drug|cisplatin|Given IV
16384356|NCT00012194|Other|laboratory biomarker analysis|Correlative studies
16384357|NCT00012181|Drug|alvocidib|Given IV
16384358|NCT00012181|Other|pharmacological study|Correlative studies
16384359|NCT00012168|Drug|isosulfan blue|
16384360|NCT00012168|Genetic|polymerase chain reaction|
16384361|NCT00012168|Other|immunohistochemistry staining method|
16384362|NCT00012168|Procedure|lymphangiography|
16384363|NCT00012168|Procedure|radionuclide imaging|
16384364|NCT00012168|Procedure|sentinel lymph node biopsy|
16384365|NCT00012168|Radiation|technetium Tc 99m sulfur colloid|
16384366|NCT00012103|Other|bronchoalveolar lavage|
16384367|NCT00012103|Other|screening questionnaire administration|
16384368|NCT00012103|Other|sputum cytology|
16384369|NCT00012103|Procedure|bronchoscopic and lung imaging studies|
16384370|NCT00012103|Procedure|bronchoscopy|
16384371|NCT00012103|Procedure|computed tomography|
16384372|NCT00012103|Procedure|study of high risk factors|
16384373|NCT00012064|Biological|therapeutic autologous dendritic cells|Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
16384374|NCT00012051|Biological|filgrastim|
16384375|NCT00012051|Biological|rituximab|
16384376|NCT00012051|Drug|carmustine|
16384377|NCT00012051|Drug|cisplatin|
16384378|NCT00012051|Drug|cytarabine|
16384379|NCT00012051|Drug|dexamethasone|
16384380|NCT00012051|Drug|etoposide|
16384381|NCT00012051|Drug|ifosfamide|
16384382|NCT00012051|Drug|melphalan|
16384383|NCT00012051|Drug|methotrexate|
16384384|NCT00012051|Procedure|bone marrow ablation with stem cell support|
16384385|NCT00012051|Procedure|peripheral blood stem cell transplantation|
16384386|NCT00012051|Radiation|radiation therapy|
16384387|NCT00012038|Drug|irofulven|
16384388|NCT00012025|Drug|fulvestrant|
16384389|NCT00012012|Drug|Amifostine trihydrate|Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections.
16384390|NCT00012012|Drug|Cisplatin|Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg/m^2 by IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.
16384391|NCT00012012|Radiation|Intracavitary brachytherapy|For low dose rate (LDR) brachytherapy, cesium will be given in one to two intracavitary applications, within two weeks of completion of external radiation. The interval between the two applications will be one to three weeks. It is recommended that the total course of treatment be completed in less than eight weeks. High dose rate (HDR) brachytherapy may start as early as week two of external radiation. The minimum cumulative external and intracavitary dose should be 85 Gy.
16384392|NCT00012012|Radiation|External beam radiation therapy|Patients will receive 1.8 Gy daily for five weeks for a total dose of 45 Gy; involved lateral parametrium and/or pelvic nodes should be boosted for a total dose (including intracavitary treatment) of 60 Gy ± 5%.
16384393|NCT00011999|Drug|cisplatin|
16384394|NCT00011999|Drug|paclitaxel|
16384395|NCT00011999|Procedure|conventional surgery|
16384396|NCT00011999|Radiation|radiation therapy|
16384397|NCT00011986|Drug|Paclitaxel|Given IV
16384398|NCT00011986|Drug|Carboplatin|Given IV
16384399|NCT00011986|Drug|Gemcitabine Hydrochloride|Given IV
16384400|NCT00011986|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|
16384401|NCT00011986|Drug|Topotecan Hydrochloride|Given IV
16384402|NCT00011986|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16384403|NCT00011960|Drug|cisplatin|
16384404|NCT00011960|Drug|paclitaxel|
16384405|NCT00011960|Procedure|adjuvant therapy|
16384406|NCT00011960|Radiation|radiation therapy|
16384407|NCT00011921|Biological|filgrastim|
16384408|NCT00011921|Drug|carboplatin|
16384409|NCT00011921|Drug|epirubicin hydrochloride|
16384410|NCT00011921|Drug|etoposide|
16384411|NCT00011921|Drug|etoposide phosphate|
16384412|NCT00011921|Drug|ifosfamide|
16384413|NCT00011921|Drug|paclitaxel|
16384414|NCT00011921|Procedure|autologous bone marrow transplantation|
16384415|NCT00011921|Procedure|bone marrow ablation with stem cell support|
16384416|NCT00011921|Procedure|peripheral blood stem cell transplantation|
16384417|NCT00011921|Radiation|radiation therapy|
16384418|NCT00010270|Biological|LMB-9 immunotoxin|
16384515|NCT00008060|Drug|fluorouracil|
16384600|NCT00006747|Drug|sargramostim|IV
16384419|NCT00010257|Drug|carboplatin|Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
16384420|NCT00010257|Drug|paclitaxel|225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
16384421|NCT00010218|Drug|karenitecin|
16384422|NCT00010205|Drug|benzoylphenylurea|Given orally
16384423|NCT00010205|Other|pharmacological study|Correlative studies
16384424|NCT00010192|Biological|rituximab|Given IV
16384425|NCT00010192|Biological|aldesleukin|Given SC
16384426|NCT00010192|Other|laboratory biomarker analysis|Correlative studies
16384427|NCT00010192|Other|pharmacological study|Correlative studies
16384428|NCT00010166|Drug|gemcitabine hydrochloride|
16384429|NCT00010166|Procedure|adjuvant therapy|
16384430|NCT00010166|Radiation|radiation therapy|
16384431|NCT00010153|Drug|fulvestrant|
16384432|NCT00010153|Procedure|conventional surgery|
16384433|NCT00010140|Drug|docetaxel|
16384434|NCT00010140|Drug|epirubicin hydrochloride|
16384435|NCT00010140|Drug|tamoxifen citrate|
16384436|NCT00010140|Procedure|adjuvant therapy|
16384437|NCT00010075|Drug|fluorouracil|
16384438|NCT00010075|Drug|leucovorin calcium|
16384439|NCT00010075|Drug|mitoxantrone hydrochloride|
16384440|NCT00010062|Drug|fluorouracil|
16384441|NCT00010062|Radiation|radiation therapy|
16384442|NCT00010049|Drug|imatinib mesylate|
16384443|NCT00010023|Drug|capecitabine|
16384444|NCT00010023|Drug|cisplatin|
16384445|NCT00009984|Drug|fludarabine phosphate|Given IV
16384446|NCT00009984|Drug|thalidomide|Given orally
16384447|NCT00009971|Drug|fenretinide|
16384448|NCT00009945|Drug|clodronate|1600 mg PO daily
16384449|NCT00009945|Drug|placebo|2 pills PO daily
16384450|NCT00009880|Biological|filgrastim|
16384451|NCT00009880|Drug|cisplatin|
16384452|NCT00009880|Drug|fluorouracil|
16384453|NCT00009880|Drug|paclitaxel|
16384454|NCT00009880|Radiation|radiation therapy|
16384455|NCT00009854|Drug|carmustine in ethanol|
16384456|NCT00009854|Procedure|conventional surgery|
16384457|NCT00009776|Biological|monoclonal antibody Lym-1|
16384458|NCT00009776|Drug|cyclosporine|
16384459|NCT00009776|Drug|paclitaxel|
16384460|NCT00009776|Radiation|indium In 111 monoclonal antibody Lym-1|
16384461|NCT00009776|Radiation|yttrium Y 90 monoclonal antibody Lym-1|
16384462|NCT00009763|Biological|filgrastim|
16384463|NCT00009763|Biological|monoclonal antibody m170|
16384464|NCT00009763|Drug|cyclosporine|
16384465|NCT00009763|Drug|paclitaxel|
16384466|NCT00009763|Procedure|peripheral blood stem cell transplantation|
16384467|NCT00009763|Radiation|yttrium Y 90 monoclonal antibody m170|
16384468|NCT00009750|Biological|filgrastim|
16384469|NCT00009750|Biological|monoclonal antibody m170|
16384470|NCT00009750|Drug|cyclosporine|
16384471|NCT00009750|Drug|paclitaxel|
16384472|NCT00009750|Procedure|peripheral blood stem cell transplantation|
16384473|NCT00009750|Radiation|indium In 111 monoclonal antibody m170|
16384474|NCT00009750|Radiation|yttrium Y 90 monoclonal antibody m170|
16384475|NCT00009711|Procedure|management of therapy complications|
16384476|NCT00008697|Drug|arsenic trioxide|
16384477|NCT00008437|Device|high-intensity focused ultrasound ablation|
16384478|NCT00008411|Drug|Docetaxel|Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
16384479|NCT00008411|Drug|Docetaxel|35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
16384480|NCT00008385|Other|placebo|Given orally
16384481|NCT00008385|Drug|selenium|Given orally
16384482|NCT00008346|Diagnostic Test|Full Field Digital Mammography|Radiologic test to screen women for Breast cancer using digital detectors
16384483|NCT00008346|Diagnostic Test|Screen Film Mammography|Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen
16384484|NCT00008307|Biological|anti-thymocyte globulin|
16384485|NCT00008307|Drug|cyclosporine|
16384486|NCT00008307|Drug|fludarabine phosphate|
16384487|NCT00008307|Drug|melphalan|
16384488|NCT00008307|Drug|methylprednisolone|
16384489|NCT00008307|Drug|mycophenolate mofetil|
16384490|NCT00008307|Procedure|allogeneic bone marrow transplantation|
16384491|NCT00008307|Procedure|peripheral blood stem cell transplantation|
16384492|NCT00008307|Procedure|syngeneic bone marrow transplantation|
16384493|NCT00008294|Drug|FOLFOX regimen|
16384494|NCT00008294|Drug|dexamethasone|
16384495|NCT00008294|Drug|floxuridine|
16384496|NCT00008294|Drug|fluorouracil|
16384497|NCT00008294|Drug|leucovorin calcium|
16384498|NCT00008294|Drug|oxaliplatin|
16384499|NCT00008268|Biological|filgrastim|
16384500|NCT00008268|Drug|melphalan|
16384501|NCT00008216|Procedure|Peripheral Blood Stem Cell Transplantation|
16384502|NCT00008190|Biological|aldesleukin|
16384503|NCT00008190|Biological|filgrastim|
16384504|NCT00008190|Drug|busulfan|
16384505|NCT00008190|Drug|cyclophosphamide|
16384506|NCT00008190|Drug|etoposide|
16384507|NCT00008190|Drug|melphalan|
16384508|NCT00008190|Procedure|peripheral blood stem cell transplantation|
16384509|NCT00008164|Procedure|umbilical cord blood transplantation|
16384510|NCT00008138|Drug|carboplatin|pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles
16384511|NCT00008138|Drug|paclitaxel|pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles
16384512|NCT00008138|Procedure|debulking surgery|exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
16384513|NCT00008060|Drug|FOLFIRI regimen|
16384514|NCT00008060|Drug|FOLFOX regimen|
16384516|NCT00008060|Drug|irinotecan hydrochloride|
16384517|NCT00008060|Drug|leucovorin calcium|
16384518|NCT00008060|Drug|oxaliplatin|
16384519|NCT00008047|Drug|fluorouracil|
16384520|NCT00008047|Drug|hydroxyurea|
16384521|NCT00008047|Drug|paclitaxel|
16384522|NCT00008047|Procedure|conventional surgery|
16384523|NCT00008047|Radiation|radiation therapy|
16384524|NCT00008008|Biological|filgrastim|
16384525|NCT00008008|Biological|sargramostim|
16384526|NCT00008008|Drug|cyclophosphamide|
16384527|NCT00008008|Drug|thiotepa|
16384528|NCT00008008|Procedure|autologous bone marrow transplantation|
16384529|NCT00008008|Procedure|bone marrow ablation with stem cell support|
16384530|NCT00008008|Procedure|peripheral blood stem cell transplantation|
16384531|NCT00007995|Biological|filgrastim|
16384532|NCT00007995|Biological|recombinant interferon alfa|
16384533|NCT00007995|Biological|sargramostim|
16384534|NCT00007995|Drug|busulfan|
16384535|NCT00007995|Drug|cyclophosphamide|
16384536|NCT00007995|Drug|melphalan|
16384537|NCT00007995|Procedure|autologous bone marrow transplantation|
16384538|NCT00007995|Procedure|bone marrow ablation with stem cell support|
16384539|NCT00007995|Procedure|peripheral blood stem cell transplantation|
16384540|NCT00007982|Biological|filgrastim|
16384541|NCT00007982|Drug|carmustine|
16384542|NCT00007982|Drug|cisplatin|
16384543|NCT00007982|Drug|cyclophosphamide|
16384544|NCT00007982|Drug|etoposide|
16384545|NCT00007982|Drug|thiotepa|
16384546|NCT00007982|Procedure|adjuvant therapy|
16384547|NCT00007982|Procedure|autologous bone marrow transplantation|
16384548|NCT00007982|Procedure|bone marrow ablation with stem cell support|
16384549|NCT00007982|Procedure|peripheral blood stem cell transplantation|
16384550|NCT00007956|Biological|monoclonal antibody mono-dgA-RFB4|
16384551|NCT00007930|Procedure|conventional surgery|
16384552|NCT00007930|Procedure|laparoscopic surgery|
16384553|NCT00007904|Biological|filgrastim|Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC > 10,000/uL x1 day after the nadir cycles 1-3.
16384554|NCT00007904|Drug|cyclophosphamide|cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3
16384555|NCT00007904|Drug|doxorubicin hydrochloride|Patients then receive doxorubicin IV on day 1.
16384556|NCT00007904|Drug|paclitaxel|Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3
16384557|NCT00007904|Drug|tamoxifen citrate|tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed
16384558|NCT00007904|Procedure|adjuvant therapy|Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
16384559|NCT00007904|Radiation|radiation therapy|Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
16384560|NCT00007891|Biological|filgrastim|
16384561|NCT00007891|Procedure|autologous bone marrow transplantation|
16384562|NCT00007891|Procedure|peripheral blood stem cell transplantation|
16384563|NCT00007891|Radiation|indium In 111 monoclonal antibody BrE-3|
16384564|NCT00007891|Radiation|yttrium Y 90 monoclonal antibody BrE-3|
16384565|NCT00007865|Biological|rituximab|
16384566|NCT00007865|Drug|carboplatin|
16384567|NCT00007865|Drug|etoposide|
16384568|NCT00007865|Drug|ifosfamide|
16384569|NCT00007826|Biological|BCG vaccine|
16384570|NCT00007826|Biological|monoclonal antibody 105AD7 anti-idiotype vaccine|
16384571|NCT00007826|Drug|alum adjuvant|
16384572|NCT00006994|Dietary Supplement|glutamine|20 cc three times daily for 60 days
16384573|NCT00006994|Radiation|radiation therapy|Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.
16384574|NCT00006994|Drug|l-glutamine placebo|20 cc three times daily for 60 days
16384575|NCT00006981|Biological|SS1(dsFv)-PE38 immunotoxin|
16384576|NCT00006942|Drug|bryostatin 1|Given IV
16384577|NCT00006942|Drug|cisplatin|Given IV
16384578|NCT00006942|Other|laboratory biomarker analysis|Correlative studies
16384579|NCT00006929|Drug|suramin|Given IV
16384580|NCT00006929|Drug|carboplatin|Given IV
16384581|NCT00006929|Drug|paclitaxel|Given IV
16384582|NCT00006929|Other|pharmacological study|Correlative studies
16384583|NCT00006929|Other|laboratory biomarker analysis|Correlative studies
16384584|NCT00006916|Biological|bleomycin|
16384585|NCT00006916|Device|Ommaya reservoir|
16384586|NCT00006916|Radiation|radiation therapy|60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
16384587|NCT00006903|Drug|Fulvestrant|Given intramuscularly
16384588|NCT00006825|Biological|trastuzumab|
16384589|NCT00006825|Drug|pegylated liposomal doxorubicin hydrochloride|
16384590|NCT00006773|Drug|bortezomib|Given IV
16384591|NCT00006760|Biological|filgrastim|subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
16384592|NCT00006760|Drug|ifosfamide|V over 24 hours on days 1-4
16384593|NCT00006760|Drug|vinorelbine tartrate|IV over 6-10 minutes on days 1 and 5.
16384594|NCT00006747|Drug|carmustine|IV
16384595|NCT00006747|Drug|melphalan|IV
16384596|NCT00006747|Drug|etoposide|IV
16384597|NCT00006747|Drug|cytarabine|IV
16384598|NCT00006747|Drug|tacrolimus|IV
16384599|NCT00006747|Drug|methotrexate|IV
16384601|NCT00006747|Procedure|transplant|
16384602|NCT00006734|Biological|filgrastim|Given IV
16384603|NCT00006734|Drug|cyclophosphamide|Given IV
16384604|NCT00006734|Drug|doxorubicin hydrochloride|Given IV
16384605|NCT00006734|Drug|etoposide|Given IV
16384606|NCT00006734|Drug|ifosfamide|Given IV
16384607|NCT00006734|Drug|vincristine sulfate|Given IV
16384608|NCT00006734|Procedure|adjuvant therapy|
16384609|NCT00006734|Procedure|conventional surgery|
16384610|NCT00006734|Procedure|neoadjuvant therapy|
16384611|NCT00006734|Radiation|brachytherapy|
16384612|NCT00006734|Radiation|radiation therapy|
16384613|NCT00006721|Biological|rituximab|Given IV
16384614|NCT00006721|Drug|cyclophosphamide|Given IV
16384615|NCT00006721|Drug|doxorubicin|Given IV
16384616|NCT00006721|Drug|prednisone|Given orally
16384617|NCT00006721|Drug|vincristine|Given IV
16384618|NCT00006721|Radiation|tositumomab|Given IV
16384619|NCT00006695|Drug|carmustine|300 mg/m2 IV on Day -6
16384620|NCT00006695|Drug|cytarabine|100 mg/m2 BID on Days -5 through -2
16384621|NCT00006695|Drug|etoposide|100 mg/m2 BID on Days -5 through -2
16384622|NCT00006695|Drug|melphalan|140 mg/m2 IV on Day -1
16384623|NCT00006695|Procedure|peripheral blood stem cell transplantation|Following the chemotherapy, on Day 0 of treatment, the previously stored hematopoietic stem cells will be administered to the patient intravenously through a central line to the patient.
16384624|NCT00006695|Radiation|tositumomab and iodine I 131 tositumomab|"Patients will receive two administrations of Iodine-131 Anti-B1 Antibody; the dosimetric dose and the therapeutic dose. The dosimetric dose will consist of an infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by an infusion of Anti-B1 Antibody (35 mg) which has been trace labeled with 5 mCi of Iodine-131 Anti-B1 Antibody. Using whole body anterior and posterior gamma camera scans and serial imaging studies over approximately one week, the clearance of the whole body dosimetric dose will be used to calculate the subsequent therapeutic dose of Iodine-131 Anti-B1 Antibody which delivers a total body dose of 75 cGy to the subject"
16384625|NCT00006656|Drug|carmustine in ethanol|
16384626|NCT00006656|Procedure|conventional surgery|
16384627|NCT00006485|Drug|alvocidib|
16384628|NCT00006485|Drug|irinotecan hydrochloride|
16384629|NCT00006479|Drug|FOLFOX regimen|
16384630|NCT00006479|Drug|fluorouracil|
16384631|NCT00006479|Drug|leucovorin calcium|
16384632|NCT00006479|Drug|oxaliplatin|
16384633|NCT00006479|Procedure|adjuvant therapy|
16384634|NCT00006479|Procedure|conventional surgery|
16384635|NCT00006479|Procedure|neoadjuvant therapy|
16384636|NCT00006478|Biological|autologous tumor cell vaccine|
16384637|NCT00006478|Biological|keyhole limpet hemocyanin|
16384638|NCT00006478|Biological|sargramostim|
16384639|NCT00006478|Procedure|adjuvant therapy|
16384640|NCT00006477|Dietary Supplement|mistletoe extract|
16384641|NCT00006476|Drug|suramin|
16384642|NCT00006476|Procedure|conventional surgery|
16384643|NCT00006474|Drug|O6-benzylguanine|
16384644|NCT00006474|Drug|temozolomide|
16384645|NCT00006474|Procedure|conventional surgery|
16384646|NCT00006473|Drug|oxaliplatin|Given IV
16384647|NCT00006471|Drug|Fenretinide|1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
16384648|NCT00006470|Biological|monoclonal antibody 11D10 anti-idiotype vaccine|
16384649|NCT00006470|Biological|monoclonal antibody 3H1 anti-idiotype vaccine|
16384650|NCT00006470|Radiation|radiation therapy|
16384651|NCT00006469|Drug|carboplatin|
16384652|NCT00006469|Drug|paclitaxel|
16384653|NCT00006469|Procedure|conventional surgery|
16384654|NCT00006469|Procedure|neoadjuvant therapy|
16384655|NCT00006469|Radiation|radiation therapy|
16384656|NCT00006468|Drug|FOLFOX regimen|
16384657|NCT00006468|Drug|fluorouracil|
16384658|NCT00006468|Drug|leucovorin calcium|
16384659|NCT00006468|Drug|oxaliplatin|
16384660|NCT00006465|Drug|capecitabine|Patients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
16384661|NCT00006465|Drug|irinotecan hydrochloride|Patients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
16384662|NCT00006465|Drug|oxaliplatin|Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
16384663|NCT00006462|Drug|gemcitabine hydrochloride|
16384664|NCT00006461|Drug|cisplatin|Given IV
16384665|NCT00006461|Drug|cyclophosphamide|Given IV
16384666|NCT00006461|Drug|vincristine sulfate|Given IV
16384667|NCT00006461|Drug|etoposide|Given PO
16384668|NCT00006461|Procedure|therapeutic conventional surgery|Undergo surgery
16384669|NCT00006461|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
16384670|NCT00006456|Radiation|stereotactic radiosurgery|
16384671|NCT00006455|Drug|cyclophosphamide|
16384672|NCT00006455|Drug|cytarabine|
16384673|NCT00006455|Drug|dexamethasone|
16384674|NCT00006455|Drug|doxorubicin hydrochloride|
16384675|NCT00006455|Drug|etoposide|
16384676|NCT00006455|Drug|ifosfamide|
16384677|NCT00006455|Drug|leucovorin calcium|
16384678|NCT00006455|Drug|methotrexate|
16384679|NCT00006455|Drug|therapeutic hydrocortisone|
16384680|NCT00006455|Drug|vinblastine sulfate|
16384681|NCT00006392|Drug|Vitamin E|400 IU daily by mouth for 7-12 years
16384682|NCT00006392|Drug|Selenium|200 mcg daily for 7-12 years
16384683|NCT00006392|Other|Vitamin E placebo|daily for 7-12 years
16384684|NCT00006392|Other|selenium placebo|daily for 7-12 years
16384685|NCT00006391|Drug|oxaliplatin|
16384686|NCT00006391|Drug|topotecan hydrochloride|
16384687|NCT00006390|Biological|alemtuzumab|
16384688|NCT00006390|Biological|filgrastim|
16384689|NCT00006390|Drug|cyclophosphamide|
16384690|NCT00006390|Procedure|peripheral blood stem cell transplantation|
16384691|NCT00006390|Radiation|radiation therapy|
16384692|NCT00006389|Drug|bryostatin 1|Given IV
16384693|NCT00006389|Drug|cisplatin|Given IV
16384694|NCT00006389|Other|laboratory biomarker analysis|Correlative studies
16384695|NCT00006386|Drug|carmustine|
16384696|NCT00006386|Radiation|radiation therapy|
16384697|NCT00006386|Radiation|stereotactic radiosurgery|
16384698|NCT00006385|Biological|MART-1 antigen|
16384699|NCT00006385|Biological|gp100 antigen|
16384700|NCT00006385|Biological|incomplete Freund's adjuvant|
16384701|NCT00006385|Biological|recombinant interferon alfa|
16384702|NCT00006385|Biological|sargramostim|
16384703|NCT00006385|Biological|tyrosinase peptide|
16384704|NCT00006381|Biological|trastuzumab|
16384705|NCT00006381|Drug|celecoxib|
16384706|NCT00006379|Biological|anti-thymocyte globulin|anti-thymocyte globulin IV over at least 4 hours on days -2 and -1
16384707|NCT00006379|Biological|graft-versus-tumor induction therapy|Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
16384708|NCT00006379|Drug|cyclophosphamide|cyclophosphamide IV over 2 hours on days -3 to -2
16384709|NCT00006379|Drug|fludarabine phosphate|fludarabine IV over 30 minutes on days -8 to -4
16384710|NCT00006379|Procedure|peripheral blood stem cell transplantation|Patients undergo filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0.
16384711|NCT00006373|Drug|etoposide|Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3
16384712|NCT00006373|Drug|ifosfamide|Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6
16384713|NCT00006373|Drug|topotecan hydrochloride|Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6
16384714|NCT00006373|Procedure|autologous bone marrow transplantation|
16384715|NCT00006373|Drug|Mesna|Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6
16384716|NCT00006372|Drug|gemcitabine hydrochloride|Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
16384717|NCT00006372|Drug|pegylated liposomal doxorubicin hydrochloride|Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
16384718|NCT00006372|Drug|vinorelbine ditartrate|Patients receive vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
16384719|NCT00006366|Drug|fluorouracil|
16384720|NCT00006366|Drug|irinotecan hydrochloride|
16384721|NCT00006366|Procedure|conventional surgery|
16384722|NCT00006366|Radiation|radiation therapy|
16384723|NCT00006364|Drug|omacetaxine mepesuccinate|Given IV or SC
16384724|NCT00006364|Other|pharmacological study|Correlative studies
16384725|NCT00006364|Other|laboratory biomarker analysis|Correlative studies
16384726|NCT00006363|Drug|cytarabine|Given IV
16384727|NCT00006363|Drug|daunorubicin hydrochloride|Given IV
16384728|NCT00006363|Drug|etoposide|Given IV
16384729|NCT00006363|Drug|valspodar|Given IV
16384730|NCT00006363|Biological|filgrastim|Given SC
16384731|NCT00006363|Drug|busulfan|Given orally
16384732|NCT00006363|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSCT
16384733|NCT00006363|Procedure|peripheral blood stem cell transplantation|Undergo autologous PBSCT
16384734|NCT00006363|Biological|aldesleukin|Given SC
16384735|NCT00006363|Other|clinical observation|Undergo clinical observation
16384736|NCT00006363|Other|pharmacological study|Correlative studies
16384737|NCT00006362|Drug|bortezomib|
16384738|NCT00006360|Drug|radioprotection|
16384739|NCT00006360|Radiation|radiation therapy|
16384740|NCT00006359|Drug|LHRH agonist|Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
16384741|NCT00006359|Drug|antiandrogen|flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
16384742|NCT00006359|Radiation|radiation therapy|4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
16384743|NCT00006359|Radiation|Brachytherapy boost|Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
16384744|NCT00006356|Drug|carboplatin|
16384745|NCT00006356|Drug|cisplatin|
16384746|NCT00006356|Procedure|conventional surgery|
16384747|NCT00006355|Drug|pyrazoloacridine|
16384748|NCT00006355|Procedure|adjuvant therapy|
16384749|NCT00006355|Radiation|radiation therapy|
16384750|NCT00006354|Dietary Supplement|mistletoe extract|
16384751|NCT00006351|Drug|gemcitabine hydrochloride|
16384752|NCT00006351|Drug|lonafarnib|
16384753|NCT00006347|Radiation|indium In 111 monoclonal antibody MN-14|
16384754|NCT00006347|Radiation|yttrium Y 90 monoclonal antibody MN-14|
16384755|NCT00006340|Drug|arginine butyrate|
16384756|NCT00006340|Drug|ganciclovir|
16384757|NCT00006268|Biological|cintredekin besudotox|
16384758|NCT00006268|Drug|isolated perfusion|
16384759|NCT00006268|Procedure|conventional surgery|
16384760|NCT00006267|Drug|rubitecan|
16384761|NCT00006264|Biological|aldesleukin|
16384762|NCT00006264|Drug|ganciclovir|
16384763|NCT00006264|Drug|zidovudine|
16384764|NCT00006263|Biological|filgrastim|
16384765|NCT00006263|Drug|carboplatin|
16384766|NCT00006263|Drug|temozolomide|
16385037|NCT00005867|Drug|etoposide|
16384767|NCT00006260|Drug|cisplatin|cisplatin IV over 30 minutes on days 1-3.
16384768|NCT00006260|Drug|etoposide|etoposide IV over 60-90 minutes on days 1-3.
16384769|NCT00006260|Drug|ifosfamide|ifosfamide IV over 30 minutes on days 1-3.
16384770|NCT00006260|Drug|Mesna|Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.
16384771|NCT00006258|Biological|filgrastim|
16384772|NCT00006258|Drug|cisplatin|
16384773|NCT00006258|Drug|cyclophosphamide|
16384774|NCT00006258|Drug|etoposide|
16384775|NCT00006258|Drug|methotrexate|
16384776|NCT00006258|Drug|vincristine sulfate|
16384777|NCT00006258|Procedure|adjuvant therapy|
16384778|NCT00006258|Radiation|radiation therapy|
16384779|NCT00006256|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.
16384780|NCT00006256|Procedure|adjuvant therapy|doxorubicin and cyclophosphamide adjuvant regimen
16384781|NCT00006256|Radiation|radiation therapy|Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
16384782|NCT00006255|Procedure|radiofrequency ablation|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
16384783|NCT00006255|Procedure|thermal ablation therapy|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
16384784|NCT00006252|Drug|fludarabine phosphate|30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)
16384785|NCT00006252|Drug|Cyclophosphamide|1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)
16384786|NCT00006252|Biological|PBSC|2-8,000,000/kg CD34+ cells via infusion on Day 0
16384787|NCT00006252|Drug|G-CSF|5 ug/kg/day subQ injection until ANC > 1000/uL for 3 days beginning Day 5
16384788|NCT00006252|Biological|Donor lymphocytes|10,000,000 CD3+ cells/kg via infusion
16384789|NCT00006250|Drug|chlorambucil|
16384790|NCT00006250|Drug|dexamethasone|
16384791|NCT00006250|Drug|fludarabine phosphate|
16384792|NCT00006250|Drug|mitoxantrone hydrochloride|
16384793|NCT00006249|Biological|pegylated interferon alfa|
16384794|NCT00006249|Procedure|adjuvant therapy|
16384795|NCT00006248|Drug|cisplatin|
16384796|NCT00006248|Drug|fluorouracil|
16384797|NCT00006248|Drug|paclitaxel|
16384798|NCT00006246|Drug|busulfan|
16384799|NCT00006245|Drug|alvocidib|
16384800|NCT00006245|Drug|paclitaxel|
16384801|NCT00006244|Drug|melphalan|Given IV
16384802|NCT00006244|Biological|recombinant interferon alfa|Given SC
16384803|NCT00006244|Biological|aldesleukin|Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
16384804|NCT00006244|Procedure|in vitro-treated peripheral blood stem cell transplantation|Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
16384805|NCT00006239|Drug|sodium phenylbutyrate|
16384806|NCT00006239|Drug|tretinoin|
16384807|NCT00006237|Biological|interleukin-2|Given IV
16384808|NCT00006237|Biological|filgrastim|Given subcutaneously
16384809|NCT00006237|Biological|interferon alfa|Given IV and subcutaneously
16384810|NCT00006237|Drug|cisplatin|Given IV
16384811|NCT00006237|Drug|dacarbazine|Given IV
16384812|NCT00006237|Drug|vinblastine|Given IV
16384813|NCT00006234|Procedure|peripheral blood stem cell transplantation|
16384814|NCT00006234|Radiation|holmium Ho 166 DOTMP|
16384815|NCT00006233|Biological|therapeutic allogeneic lymphocytes|
16384816|NCT00006233|Drug|cyclosporine|
16384817|NCT00006233|Drug|fludarabine phosphate|
16384818|NCT00006233|Drug|mycophenolate mofetil|
16384819|NCT00006233|Procedure|peripheral blood stem cell transplantation|
16384820|NCT00006233|Radiation|radiation therapy|
16384821|NCT00006232|Drug|dexamethasone|
16384822|NCT00006232|Drug|doxorubicin hydrochloride|
16384823|NCT00006232|Drug|idarubicin|
16384824|NCT00006232|Drug|vincristine sulfate|
16384825|NCT00006231|Procedure|quality-of-life assessment|
16384826|NCT00006231|Procedure|standard follow-up care|
16384827|NCT00006231|Radiation|radiation therapy|
16384828|NCT00006230|Drug|rubitecan|
16384829|NCT00006228|Biological|trastuzumab|Given IV
16384830|NCT00006228|Biological|aldesleukin|Given SC
16384831|NCT00006228|Other|laboratory biomarker analysis|Correlative studies
16384832|NCT00006228|Other|pharmacological study|Correlative studies
16384833|NCT00006227|Drug|Paclitaxel|Given IV
16384834|NCT00006226|Drug|thalidomide|Given PO
16384835|NCT00006226|Other|laboratory biomarker analysis|Correlative studies
16384836|NCT00006221|Drug|ixabepilone|
16384837|NCT00006219|Drug|clarithromycin|
16384838|NCT00006219|Drug|prasterone|
16384839|NCT00006125|Drug|doxorubicin hydrochloride|
16384840|NCT00006125|Drug|topotecan hydrochloride|
16384841|NCT00006124|Drug|celecoxib|Given orally
16384842|NCT00006124|Drug|placebo|Given orally
16384843|NCT00006120|Drug|docetaxel|
16384844|NCT00006120|Drug|paclitaxel|
16384845|NCT00006119|Drug|hydroxyurea|
16384846|NCT00006118|Drug|cisplatin|
16384847|NCT00006118|Drug|gemcitabine hydrochloride|
16384848|NCT00006118|Drug|paclitaxel|
16384849|NCT00006114|Drug|mitoxantrone hydrochloride|
16384850|NCT00006114|Drug|vinorelbine tartrate|
16384851|NCT00006113|Biological|MART-1 antigen|
16384852|NCT00006113|Biological|aldesleukin|
16384853|NCT00006113|Biological|gp100 antigen|
16384854|NCT00006113|Biological|recombinant CD40-ligand|
16384855|NCT00006113|Biological|recombinant interferon gamma|
16384856|NCT00006113|Biological|recombinant interleukin-4|
16384857|NCT00006113|Biological|sargramostim|
16384858|NCT00006113|Biological|therapeutic autologous dendritic cells|
16384859|NCT00006113|Biological|therapeutic tumor infiltrating lymphocytes|
16384860|NCT00006113|Biological|tyrosinase peptide|
16384861|NCT00006113|Radiation|Candida albicans skin test reagent|
16384862|NCT00006110|Biological|trastuzumab|infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks
16384863|NCT00006110|Drug|cyclophosphamide|600 mg/m2, intravenous infusion every 3 weeks for four cycles
16384864|NCT00006110|Drug|doxorubicin hydrochloride|60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks
16384865|NCT00006110|Drug|paclitaxel|90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)
16384866|NCT00006110|Procedure|conventional surgery|Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting
16384867|NCT00006107|Drug|Taxotere|
16384868|NCT00006107|Procedure|Surgery|
16384869|NCT00006107|Radiation|radiation therapy|
16384870|NCT00006105|Drug|amifostine trihydrate|
16384871|NCT00006105|Drug|cisplatin|
16384872|NCT00006105|Drug|gemcitabine hydrochloride|
16384873|NCT00006105|Procedure|adjuvant therapy|
16384874|NCT00006102|Drug|becatecarin|
16384875|NCT00006101|Drug|eflornithine|Take 500mg of DFMO per day for 12 months
16384876|NCT00006101|Drug|Placebo|Take placebo per day for 12 months
16384877|NCT00006100|Biological|aldesleukin|
16384878|NCT00006100|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
16384879|NCT00006100|Drug|fludarabine phosphate|
16384880|NCT00006100|Procedure|peripheral blood stem cell transplantation|
16384881|NCT00006094|Drug|oxaliplatin|Given IV
16384882|NCT00006094|Drug|fluorouracil|Given IV
16384883|NCT00006094|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
16384884|NCT00006093|Drug|cilengitide|
16384885|NCT00006092|Drug|Arsenic Trioxide|
16384886|NCT00006089|Other|Laboratory Biomarker Analysis|Correlative studies
16384887|NCT00006089|Biological|Trastuzumab|Given IV
16384888|NCT00006078|Dietary Supplement|lycopene|
16384889|NCT00006044|Drug|therapeutic testosterone|
16384890|NCT00006042|Biological|filgrastim|
16384891|NCT00006042|Drug|cyclophosphamide|
16384892|NCT00006042|Drug|fludarabine phosphate|
16384893|NCT00006042|Drug|mycophenolate mofetil|
16384894|NCT00006042|Drug|tacrolimus|
16384895|NCT00006042|Procedure|allogeneic bone marrow transplantation|
16384896|NCT00006042|Radiation|radiation therapy|
16384897|NCT00006040|Biological|filgrastim|
16384898|NCT00006040|Drug|etoposide|
16384899|NCT00006040|Procedure|autologous bone marrow transplantation|
16384900|NCT00006040|Procedure|peripheral blood stem cell transplantation|
16384901|NCT00006040|Radiation|yttrium Y 90 monoclonal antibody M195|
16384902|NCT00006029|Drug|gemcitabine hydrochloride|
16384903|NCT00006029|Drug|pegylated liposomal doxorubicin hydrochloride|
16384904|NCT00006029|Drug|vinorelbine tartrate|
16384905|NCT00006028|Drug|cisplatin|
16384906|NCT00006028|Drug|gemcitabine hydrochloride|
16384907|NCT00006027|Drug|cisplatin|
16384908|NCT00006027|Drug|paclitaxel|
16384909|NCT00006027|Procedure|adjuvant therapy|
16384910|NCT00006027|Radiation|radiation therapy|
16384911|NCT00006025|Drug|irinotecan hydrochloride|
16384912|NCT00006025|Drug|temozolomide|
16384913|NCT00006024|Drug|lomustine|
16384914|NCT00006024|Drug|temozolomide|
16384915|NCT00006022|Biological|aldesleukin|
16384916|NCT00006022|Drug|bryostatin 1|
16384917|NCT00006021|Dietary Supplement|ascorbic acid|
16384918|NCT00006021|Drug|arsenic trioxide|
16384919|NCT00006020|Drug|nelarabine|1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
16384920|NCT00006017|Drug|becatecarin|Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
16384921|NCT00006016|Drug|thalidomide|Given orally
16384922|NCT00006016|Drug|doxorubicin hydrochloride|Given transarterially (chemoembolization)
16384923|NCT00006016|Other|laboratory biomarker analysis|Correlative studies
16384924|NCT00006015|Biological|trastuzumab|4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, & 22)
16384925|NCT00006015|Drug|fluorouracil|500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
16384926|NCT00006015|Drug|leucovorin calcium|500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break
16384927|NCT00006015|Drug|oxaliplatin|85 mg/sq m IV infusion over 2 hours Days 1 & 15 of each cycle
16384928|NCT00006011|Drug|Doxorubicin Hydrochloride|Given IV
16384929|NCT00006011|Drug|Cisplatin|Given IV
16384930|NCT00006011|Biological|Filgrastim|Given SC
16384931|NCT00006011|Biological|Pegfilgrastim|Given SC
16384932|NCT00006011|Drug|Paclitaxel|Given IV
16384933|NCT00006010|Drug|docetaxel|
16384934|NCT00006010|Drug|gemcitabine hydrochloride|
16384935|NCT00006007|Drug|gemcitabine hydrochloride|
16384936|NCT00006007|Drug|pemetrexed disodium|
16384937|NCT00006006|Biological|recombinant interferon alfa|
16384938|NCT00006006|Drug|thalidomide|
16384939|NCT00006005|Drug|thalidomide|
16384940|NCT00006004|Drug|carboplatin|
16384941|NCT00006004|Drug|cisplatin|
16384942|NCT00006004|Drug|gemcitabine hydrochloride|
16384943|NCT00006004|Drug|paclitaxel|
16384944|NCT00006003|Drug|semaxanib|Given IV
16384945|NCT00006003|Other|laboratory biomarker analysis|Correlative studies
16384946|NCT00005997|Drug|becatecarin|Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
16384947|NCT00005990|Drug|tipifarnib|
16384948|NCT00005990|Drug|topotecan hydrochloride|
16384949|NCT00005987|Drug|carmustine|
16384950|NCT00005987|Drug|cyclophosphamide|
16384951|NCT00005987|Drug|dexamethasone|
16384952|NCT00005987|Drug|etoposide|
16384953|NCT00005987|Drug|filgrastim|
16384954|NCT00005987|Drug|mitoxantrone hydrochloride|
16384955|NCT00005987|Drug|recombinant interferon alfa|
16384956|NCT00005987|Drug|sargramostim|
16384957|NCT00005987|Procedure|bone marrow ablation with stem cell support|
16384958|NCT00005987|Procedure|peripheral blood stem cell transplantation|
16384959|NCT00005987|Procedure|radiation therapy|
16384960|NCT00005985|Biological|filgrastim|
16384961|NCT00005985|Drug|carmustine|
16384962|NCT00005985|Drug|cyclophosphamide|
16384963|NCT00005985|Drug|cytarabine|
16384964|NCT00005985|Drug|dexamethasone|
16384965|NCT00005985|Drug|etoposide|
16384966|NCT00005985|Drug|mitoxantrone hydrochloride|
16384967|NCT00005985|Procedure|peripheral blood stem cell transplantation|
16384968|NCT00005985|Radiation|radiation therapy|
16384969|NCT00005984|Drug|cyclophosphamide|intravenously over 2 hours on day 1 and on days -7 and -6
16384970|NCT00005984|Drug|filgrastim|filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
16384971|NCT00005984|Drug|recombinant interferon alfa|Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
16384972|NCT00005984|Procedure|peripheral blood stem cell transplantation|Patients receive the PBSC transplantation on day 0.
16384973|NCT00005984|Procedure|radiation therapy|total body irradiation twice a day on days -4 through -1
16384974|NCT00005983|Radiation|radiation therapy|
16384975|NCT00005983|Procedure|surgery|surgery
16384976|NCT00005982|Drug|nelarabine|Given IV
16384977|NCT00005982|Other|pharmacological study|Correlative studies
16384978|NCT00005981|Drug|O6-benzylguanine|Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
16384979|NCT00005981|Drug|carmustine|Carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
16384980|NCT00005980|Drug|pegylated liposomal doxorubicin hydrochloride|
16384981|NCT00005979|Drug|FOLFIRI regimen|
16384982|NCT00005979|Drug|fluorouracil|
16384983|NCT00005979|Drug|irinotecan hydrochloride|
16384984|NCT00005979|Drug|leucovorin calcium|
16384985|NCT00005976|Drug|carboplatin|
16384986|NCT00005976|Drug|pyrazoloacridine|
16384987|NCT00005973|Drug|BMS-214662|Given IV
16384988|NCT00005973|Other|laboratory biomarker analysis|Correlative studies
16384989|NCT00005970|Drug|Aromatase Inhibition Therapy|Given orally
16384990|NCT00005970|Drug|Cyclophosphamide|Given IV
16384991|NCT00005970|Drug|Doxorubicin Hydrochloride|Given IV
16384992|NCT00005970|Other|Laboratory Biomarker Analysis|Correlative studies
16384993|NCT00005970|Drug|Paclitaxel|Given IV
16384994|NCT00005970|Drug|Tamoxifen Citrate|Given orally
16384995|NCT00005970|Biological|Trastuzumab|Given IV
16384996|NCT00005967|Drug|tipifarnib|
16384997|NCT00005966|Biological|recombinant interferon alfa|
16384998|NCT00005966|Drug|thalidomide|
16384999|NCT00005961|Drug|O6-benzylguanine|
16385000|NCT00005961|Drug|carmustine|
16385001|NCT00005957|Radiation|Standard Breast Irradiation|Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
16385002|NCT00005957|Radiation|Breast Radiation plus Regional Radiation|Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
16385003|NCT00005955|Drug|temozolomide|
16385004|NCT00005954|Drug|temozolomide|
16385005|NCT00005952|Biological|filgrastim|
16385006|NCT00005952|Drug|temozolomide|
16385007|NCT00005952|Procedure|peripheral blood stem cell transplantation|
16385008|NCT00005951|Drug|irinotecan hydrochloride|
16385009|NCT00005951|Drug|temozolomide|
16385010|NCT00005949|Biological|aldesleukin|Given SC
16385011|NCT00005949|Biological|gp100:209-217(210M) peptide vaccine|Given SC
16385012|NCT00005949|Other|laboratory biomarker analysis|Correlative studies
16385013|NCT00005945|Drug|cyclophosphamide|Given IV
16385014|NCT00005945|Drug|cytarabine|Given IT
16385015|NCT00005945|Drug|daunorubicin hydrochloride|Given IV
16385016|NCT00005945|Drug|dexamethasone|Given PO
16385017|NCT00005945|Drug|doxorubicin hydrochloride|Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
16385018|NCT00005945|Drug|mercaptopurine|Given PO
16385019|NCT00005945|Drug|methotrexate|Given PO and IT
16385020|NCT00005945|Drug|pegaspargase|Given IM
16385021|NCT00005945|Drug|thioguanine|Given PO
16385022|NCT00005945|Drug|vincristine sulfate|Given IV
16385023|NCT00005945|Radiation|radiation therapy|Undergo radiation therapy
16385024|NCT00005941|Biological|therapeutic allogeneic lymphocytes|
16385025|NCT00005941|Drug|cyclosporine|
16385026|NCT00005941|Drug|fludarabine phosphate|
16385027|NCT00005941|Drug|mycophenolate mofetil|
16385028|NCT00005941|Procedure|peripheral blood stem cell transplantation|
16385029|NCT00005941|Radiation|radiation therapy|
16385030|NCT00005879|Drug|arzoxifene|one tablet daily
16385031|NCT00005879|Drug|Placebo|matched tablet dialy
16385032|NCT00005878|Drug|celecoxib|
16385033|NCT00005867|Biological|bleomycin sulfate|
16385034|NCT00005867|Drug|CHOP regimen|
16385035|NCT00005867|Drug|cyclophosphamide|
16385036|NCT00005867|Drug|doxorubicin hydrochloride|
16385038|NCT00005867|Drug|mitoxantrone hydrochloride|
16385039|NCT00005867|Drug|prednisolone|
16385040|NCT00005867|Drug|vincristine sulfate|
16385041|NCT00005863|Biological|filgrastim|
16385042|NCT00005863|Drug|cytarabine|
16385043|NCT00005863|Drug|daunorubicin hydrochloride|
16385044|NCT00005863|Drug|etoposide|
16385045|NCT00005863|Drug|fludarabine phosphate|
16385046|NCT00005863|Drug|tretinoin|
16385047|NCT00005859|Drug|tipifarnib|
16385048|NCT00005858|Biological|LMB-9 immunotoxin|
16385049|NCT00005856|Drug|oxaliplatin|Given IV
16385050|NCT00005856|Other|pharmacological study|Correlative studies
16385051|NCT00005855|Drug|carmustine|
16385052|NCT00005855|Drug|efaproxiral|
16385053|NCT00005853|Biological|anti-thymocyte globulin|
16385054|NCT00005853|Biological|etanercept|
16385055|NCT00005851|Drug|fludarabine phosphate|Given IV
16385056|NCT00005851|Radiation|total-body irradiation|Undergo TBI
16385057|NCT00005851|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
16385058|NCT00005851|Drug|cyclosporine|Given PO or IV
16385059|NCT00005851|Drug|mycophenolate mofetil|Given PO or IV
16385060|NCT00005851|Procedure|peripheral blood stem cell transplantation|Undergo nonmyeloablative allogeneic PBSC transplantation
16385061|NCT00005851|Biological|therapeutic allogeneic lymphocytes|Undergo DLI
16385062|NCT00005851|Other|laboratory biomarker analysis|Correlative studies
16385063|NCT00005850|Drug|cisplatin|80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.
16385064|NCT00005850|Drug|fluoxetine|10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.
16385065|NCT00005850|Drug|gemcitabine hydrochloride|1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.
16385066|NCT00005847|Biological|recombinant interferon alfa|
16385067|NCT00005847|Drug|estramustine phosphate sodium|
16385068|NCT00005847|Drug|isotretinoin|
16385069|NCT00005847|Drug|mitoxantrone hydrochloride|
16385070|NCT00005847|Drug|paclitaxel|
16385071|NCT00005847|Drug|vinorelbine ditartrate|
16385072|NCT00005844|Drug|oxaliplatin|
16385073|NCT00005840|Drug|Paclitaxel|Given IV
16385074|NCT00005840|Drug|Cisplatin|Given IV
16385075|NCT00005840|Radiation|Radiation Therapy|Undergo whole abdominal radiation therapy
16385076|NCT00005838|Drug|shark cartilage extract AE-941|Given orally
16385077|NCT00005838|Other|placebo|Given orally
16385078|NCT00005838|Drug|cisplatin|Given IV
16385079|NCT00005838|Drug|vinorelbine tartrate|Given IV
16385080|NCT00005838|Drug|carboplatin|Given IV
16385081|NCT00005838|Drug|paclitaxel|Given IV
16385082|NCT00005838|Radiation|radiation therapy|Undergo radiotherapy
16385083|NCT00005835|Drug|buthionine sulfoximine|Dose fixed at a bolus of 3 gm/M2 given over 30 minutes followed by a continuous infusion of 1 gm/M2/hour for 72 hours (total 72.5 hours).Total daily infusion dose (minus the initial bolus)will be 24 gm/m2/day.
16385084|NCT00005835|Drug|melphalan|The dose level of melphalan will be assigned at study entry onto protocol. There will be 6 dose levels ranging from 20mg/m2/day x 2 days (dose level 1a) to 62.5 mg/m2/day x 2 days (dose level 6a). The starting dose level will be 1a, with a decrease to level 0a (15mg/m2/day x2 days) if there is unacceptable toxicity.
16385085|NCT00005835|Procedure|Peripheral blood stem cell infusion|Stem cells will be infused intravenously on day 0 , 24 hours after BSO continuous infusion is completed.Infused within 1.5 hours of thawing via a central venous catheter over 15-30 minutes.
16385086|NCT00005835|Other|Filgrastim|5 microgram/kg/day , subcutaneous or intravenous, given daily beginning day 0. First dose to begin 4 hours after completion of stem cell infusion and then to continue till ANC >/= 1500 mm3 for three consecutive days.
16385087|NCT00005831|Biological|trastuzumab|Given IV
16385088|NCT00005831|Drug|paclitaxel|Given IV
16385089|NCT00005831|Drug|carboplatin|Given IV
16385090|NCT00005831|Drug|gemcitabine hydrochloride|Given IV
16385091|NCT00005831|Other|laboratory biomarker analysis|Correlative studies
16385092|NCT00005830|Drug|Doxorubicin Hydrochloride|Given IV
16385093|NCT00005830|Drug|Cisplatin|Given IV
16385094|NCT00005830|Radiation|Radiation Therapy|Undergo radiation therapy
16385095|NCT00005825|Drug|cisplatin|
16385096|NCT00005825|Drug|mitomycin C|
16385097|NCT00005825|Drug|tretinoin|
16385098|NCT00005825|Drug|vinorelbine tartrate|
16385099|NCT00005824|Biological|filgrastim|
16385100|NCT00005824|Drug|busulfan|
16385101|NCT00005824|Drug|cyclophosphamide|
16385102|NCT00005824|Procedure|peripheral blood stem cell transplantation|
16385103|NCT00005823|Drug|cytarabine|
16385104|NCT00005823|Drug|daunorubicin hydrochloride|
16385105|NCT00005823|Drug|etoposide|
16385106|NCT00005823|Drug|hydroxyurea|
16385107|NCT00005823|Drug|idarubicin|
16385108|NCT00005823|Drug|mitoxantrone hydrochloride|
16385109|NCT00005823|Drug|thioguanine|
16385110|NCT00005823|Drug|tretinoin|
16385111|NCT00005823|Drug|valspodar|
16385112|NCT00005822|Drug|doxorubicin hydrochloride|Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
16385113|NCT00005822|Drug|semaxanib|For all subsequent courses, after course 1 patients SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
16385114|NCT00005822|Procedure|conventional surgery|Patients undergo a modified radical mastectomy.
16385268|NCT00005580|Drug|fludarabine phosphate|
16385115|NCT00005822|Radiation|radiation therapy|Patients undergo radiotherapy to the chest wall and regional lymph nodes.
16385116|NCT00005822|Drug|tamoxifen|Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.
16385117|NCT00005821|Drug|patent blue V dye|
16385118|NCT00005821|Procedure|conventional surgery|
16385119|NCT00005821|Procedure|lymphangiography|
16385120|NCT00005821|Procedure|radionuclide imaging|
16385121|NCT00005821|Procedure|sentinel lymph node biopsy|
16385122|NCT00005821|Radiation|Technetium Tc 99m human serum albumin colloid|
16385123|NCT00005819|Drug|cisplatin|Patients receive cisplatin IV over 30 minutes on day 7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.
16385124|NCT00005819|Drug|fenretinide|Patients receive oral fenretinide twice daily for 7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
16385125|NCT00005819|Drug|paclitaxel|Patients receive paclitaxel IV over 3 hours. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.
16385126|NCT00005817|Drug|becatecarin|Given IV
16385127|NCT00005817|Other|laboratory biomarker analysis|Correlative studies
16385128|NCT00005815|Drug|temozolomide|
16385129|NCT00005815|Drug|thalidomide|
16385130|NCT00005812|Drug|temozolomide|
16385131|NCT00005811|Drug|topotecan hydrochloride|Given IT
16385132|NCT00005811|Other|laboratory biomarker analysis|Correlative studies
16385133|NCT00005808|Drug|motexafin lutetium|Given IV
16385134|NCT00005808|Drug|photodynamic therapy|Undergo laser therapy
16385135|NCT00005808|Procedure|loop electrosurgical excision procedure|Undergo LEEP
16385136|NCT00005808|Other|laboratory biomarker analysis|Correlative studies
16385137|NCT00005807|Drug|BMS-247550|anticancer agent for the treatment of patients with malignant tumors.
16385138|NCT00005803|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous transplantation
16385139|NCT00005803|Procedure|Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation|Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
16385140|NCT00005803|Drug|Carmustine|Given IV
16385141|NCT00005803|Drug|Cyclophosphamide|Given IV
16385142|NCT00005803|Drug|Cyclosporine|Given PO
16385143|NCT00005803|Drug|Cytarabine|Given IV
16385144|NCT00005803|Drug|Etoposide|Given IV
16385145|NCT00005803|Drug|Fludarabine Phosphate|Given IV
16385146|NCT00005803|Other|Laboratory Biomarker Analysis|Correlative studies
16385147|NCT00005803|Drug|Melphalan|Given IV
16385148|NCT00005803|Drug|Mycophenolate Mofetil|Given PO
16385149|NCT00005803|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic transplantation
16385150|NCT00005803|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic transplantation
16385151|NCT00005803|Biological|Therapeutic Autologous Lymphocytes|IV donor lymphocyte infusion
16385152|NCT00005803|Radiation|Total-Body Irradiation|Undergo radiotherapy
16385153|NCT00005802|Biological|aldesleukin|
16385154|NCT00005802|Biological|filgrastim|
16385155|NCT00005802|Biological|therapeutic allogeneic lymphocytes|
16385156|NCT00005802|Drug|cytarabine|
16385157|NCT00005802|Drug|etoposide|
16385158|NCT00005802|Drug|fludarabine phosphate|
16385159|NCT00005802|Drug|methotrexate|
16385160|NCT00005802|Drug|mitoxantrone hydrochloride|
16385161|NCT00005802|Drug|therapeutic hydrocortisone|
16385162|NCT00005802|Radiation|radiation therapy|
16385163|NCT00005797|Drug|busulfan|administered on Day -7 through Day -4. The total dose is 12.8 mg/kg
16385164|NCT00005797|Drug|Cyclophosphamide|administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)
16385165|NCT00005797|Drug|VP-16|administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is >/= 150% of IBW, in which case adjusted body weight will be used.
16385166|NCT00005797|Radiation|Fractionated Total Body Irradiation (FTBI)|FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.
16385167|NCT00005788|Biological|aldesleukin|
16385168|NCT00005787|Biological|epoetin alfa|
16385169|NCT00005787|Biological|filgrastim|
16385170|NCT00005787|Biological|recombinant flt3 ligand|
16385171|NCT00005787|Biological|recombinant interleukin-3|
16385172|NCT00005787|Biological|sargramostim|
16385173|NCT00005787|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16385174|NCT00005786|Drug|arsenic trioxide|Given IV
16385175|NCT00005786|Other|laboratory biomarker analysis|Correlative studies
16385176|NCT00005647|Drug|paclitaxel|Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
16385177|NCT00005647|Drug|semaxanib|Patients receive SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
16385178|NCT00005644|Drug|gemcitabine hydrochloride|
16385179|NCT00005644|Drug|paclitaxel|
16385180|NCT00005639|Drug|Azacitidine Injection|subcutaneous injection (SC)
16385181|NCT00005639|Drug|sodium phenylbutyrate|continuous intravenous (CIV)
16385182|NCT00005638|Drug|cisplatin|
16385183|NCT00005638|Drug|irinotecan hydrochloride|
16385184|NCT00005638|Radiation|radiation therapy|
16385185|NCT00005637|Drug|carmustine|
16385186|NCT00005637|Drug|temozolomide|
16385187|NCT00005627|Drug|carboplatin|
16385188|NCT00005627|Drug|docetaxel|
16385189|NCT00005627|Drug|estramustine phosphate sodium|
16385190|NCT00005623|Drug|cyproterone acetate|
16385191|NCT00005623|Procedure|quality-of-life assessment|
16385269|NCT00005579|Drug|dolastatin 10|
16385529|NCT00004141|Drug|Cisplatin|
16385192|NCT00005622|Drug|cyclophosphamide|Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)
16385193|NCT00005622|Radiation|TBI|FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
16385194|NCT00005617|Biological|dendritic cell-MART-1 peptide vaccine|Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.
16385195|NCT00005617|Procedure|leukapheresis|Patients require a single leukapheresis to obtain 2x10^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.
16385196|NCT00005606|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes|
16385197|NCT00005606|Biological|autologous Epstein-Barr virus-specific cytotoxic T lymphocytes|
16385198|NCT00005603|Drug|asparaginase|
16385199|NCT00005603|Drug|cyclophosphamide|
16385200|NCT00005603|Drug|cytarabine|
16385201|NCT00005603|Drug|daunorubicin hydrochloride|
16385202|NCT00005603|Drug|dexamethasone|
16385203|NCT00005603|Drug|doxorubicin hydrochloride|
16385204|NCT00005603|Drug|mercaptopurine|
16385205|NCT00005603|Drug|methotrexate|
16385206|NCT00005603|Drug|prednisone|
16385207|NCT00005603|Drug|thioguanine|
16385208|NCT00005603|Drug|vincristine sulfate|
16385209|NCT00005602|Drug|carboplatin|
16385210|NCT00005602|Drug|cereport|
16385211|NCT00005602|Radiation|radiation therapy|
16385212|NCT00005601|Biological|rituximab|
16385213|NCT00005601|Drug|cisplatin|
16385214|NCT00005601|Drug|cytarabine|
16385215|NCT00005601|Drug|dexamethasone|
16385216|NCT00005601|Drug|sargramostim|
16385217|NCT00005600|Procedure|management of therapy complications|
16385218|NCT00005599|Drug|bryostatin 1|
16385219|NCT00005599|Drug|paclitaxel|
16385220|NCT00005597|Drug|temozolomide|200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
16385221|NCT00005596|Drug|cyclophosphamide|
16385222|NCT00005596|Drug|cytarabine|
16385223|NCT00005596|Drug|daunorubicin hydrochloride|30 mg/m2 IV Day 1 of weeks 16, 17, and 18. Give Week 16 dose if ANC ≥ 500/μL and platelets ≥ 75,000/μL. Continue to give during Weeks 17 and 18, even in the face of uncomplicated myelosuppression
16385224|NCT00005596|Drug|dexamethasone|6 mg/m2/day divided BID for 7 days during weeks 8 and 17.
16385225|NCT00005596|Drug|leucovorin calcium|5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.
16385226|NCT00005596|Drug|mercaptopurine|50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC > 500/μL and platelets > 75,000/uL
16385227|NCT00005596|Drug|methotrexate|"IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.
~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22."
16385228|NCT00005596|Drug|pegaspargase|2,500 IU/m2 will be given IM x 1 on Days 2,3,or 4 of Week 16; > or = 1 day after the IT MTX
16385229|NCT00005596|Drug|thioguanine|60 mg/m2 po qhs during Weeks 20 and 21 (total 14 days). Start week 20 when ANC > or = 500/ul and platelets > or = 75,000/uL. Continue to give all 14 doses despite uncomplicated myelosuppression.
16385230|NCT00005596|Drug|vincristine sulfate|1.5 mg/m2 IV on Day 1 of Weeks 8, 9, 17 and 18 (max 2 mg)
16385231|NCT00005590|Drug|levofloxacin|
16385232|NCT00005589|Biological|filgrastim|
16385233|NCT00005589|Biological|rituximab|
16385234|NCT00005589|Drug|carmustine|
16385235|NCT00005589|Drug|cyclophosphamide|
16385236|NCT00005589|Drug|cytarabine|
16385237|NCT00005589|Drug|etoposide|
16385238|NCT00005589|Drug|melphalan|
16385239|NCT00005589|Procedure|bone marrow ablation with stem cell support|
16385240|NCT00005589|Procedure|peripheral blood stem cell transplantation|
16385241|NCT00005586|Drug|L-leucovorin|
16385242|NCT00005586|Drug|fluorouracil|
16385243|NCT00005586|Procedure|adjuvant therapy|
16385244|NCT00005585|Drug|cyclophosphamide|Given IV
16385245|NCT00005585|Drug|cytarabine|Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.
16385246|NCT00005585|Drug|daunorubicin hydrochloride|Given IV
16385247|NCT00005585|Drug|dexamethasone|Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
16385248|NCT00005585|Drug|leucovorin calcium|Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
16385249|NCT00005585|Drug|mercaptopurine|An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
16385250|NCT00005585|Drug|methotrexate|A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
16385251|NCT00005585|Drug|pegaspargase|E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.
16385252|NCT00005585|Drug|thioguanine|Given orally
16385253|NCT00005585|Drug|vincristine sulfate|Given IV
16385254|NCT00005584|Biological|bleomycin sulfate|
16385255|NCT00005584|Drug|ABVD regimen|
16385256|NCT00005584|Drug|BEACOPP regimen|
16385257|NCT00005584|Drug|epirubicin hydrochloride|
16385258|NCT00005584|Drug|prednisone|
16385259|NCT00005584|Drug|vinblastine sulfate|
16385260|NCT00005584|Radiation|radiation therapy|
16385261|NCT00005583|Drug|cisplatin|
16385262|NCT00005583|Drug|doxorubicin hydrochloride|
16385263|NCT00005583|Drug|epirubicin hydrochloride|
16385264|NCT00005583|Procedure|adjuvant therapy|
16385265|NCT00005583|Procedure|conventional surgery|
16385266|NCT00005583|Radiation|radiation therapy|
16385267|NCT00005580|Drug|bryostatin 1|
16385270|NCT00005095|Other|laboratory biomarker analysis|Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
16385271|NCT00005095|Other|screening questionnaire administration|Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
16385272|NCT00005095|Procedure|study of high risk factors|Subjects will be assessed for high risk factors.
16385273|NCT00005087|Biological|filgrastim|
16385274|NCT00005087|Drug|cisplatin|
16385275|NCT00005087|Drug|paclitaxel|
16385276|NCT00005087|Procedure|conventional surgery|
16385277|NCT00005087|Radiation|radiation therapy|
16385278|NCT00005079|Procedure|conventional surgery|
16385279|NCT00005074|Drug|alvocidib|
16385280|NCT00005067|Drug|motexafin lutetium|Given IV
16385281|NCT00005067|Drug|photodynamic therapy|Undergo photodynamic therapy
16385282|NCT00005062|Radiation|radiation therapy|
16385283|NCT00005060|Drug|Taxotere-Cisplatin-5FU|Preoperatively
16385284|NCT00005060|Drug|Immediate surgery|Immediate surgery followed by Taxotere-Cisplatin-5FU
16385285|NCT00005052|Biological|GM2-KLH vaccine|
16385286|NCT00005052|Biological|QS21|
16385287|NCT00005052|Procedure|adjuvant therapy|
16385288|NCT00005051|Drug|carboplatin|
16385289|NCT00005051|Drug|cisplatin|
16385290|NCT00005051|Drug|paclitaxel|
16385291|NCT00005051|Drug|topotecan hydrochloride|
16385292|NCT00005049|Drug|carboplatin|
16385293|NCT00005049|Drug|cisplatin|
16385294|NCT00005049|Drug|floxuridine|
16385295|NCT00005047|Drug|cisplatin|
16385296|NCT00005047|Drug|doxorubicin hydrochloride|
16385297|NCT00005047|Drug|methotrexate|
16385298|NCT00005047|Drug|vinblastine|
16385299|NCT00005044|Drug|Casodex|Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.
16385300|NCT00005044|Drug|Eulexin|Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.
16385301|NCT00005044|Drug|LHRH agonist|LHRH agonist of choice. The manufacturer's instructions should be followed.
16385302|NCT00005044|Radiation|radiation therapy|[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]
16385303|NCT00005039|Biological|recombinant fowlpox-prostate specific antigen vaccine|Given IM
16385304|NCT00005039|Biological|recombinant vaccinia prostate-specific antigen vaccine|Given intradermally
16385305|NCT00005039|Other|laboratory biomarker analysis|Correlative studies
16385306|NCT00005038|Biological|aldesleukin|
16385307|NCT00005038|Drug|histamine dihydrochloride|
16385308|NCT00005036|Drug|irinotecan hydrochloride|Given IV
16385309|NCT00005036|Drug|oxaliplatin|Given IV
16385310|NCT00005036|Drug|leucovorin calcium|Given IV
16385311|NCT00005036|Drug|fluorouracil|Given IV
16385312|NCT00005036|Procedure|quality-of-life assessment|Ancillary studies
16385313|NCT00005033|Biological|trastuzumab|
16385314|NCT00005033|Procedure|conventional surgery|
16385315|NCT00004936|Drug|iodinated contrast dye|
16385316|NCT00004936|Procedure|computed tomography|
16385317|NCT00004936|Procedure|magnetic resonance imaging|
16385318|NCT00004936|Radiation|gadopentetate dimeglumine|
16385319|NCT00004935|Drug|Herceptin™ (Her)|Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
16385320|NCT00004935|Drug|Herceptin™ (Her) + chemo|Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
16385321|NCT00004934|Drug|carboplatin|
16385322|NCT00004934|Drug|epirubicin hydrochloride|
16385323|NCT00004934|Drug|paclitaxel|
16385324|NCT00004934|Procedure|conventional surgery|
16385325|NCT00004932|Drug|imatinib mesylate|
16385326|NCT00004930|Drug|doxorubicin hydrochloride|
16385327|NCT00004924|Drug|irinotecan hydrochloride|
16385328|NCT00004924|Drug|paclitaxel|
16385329|NCT00004921|Biological|filgrastim|
16385330|NCT00004921|Drug|carboplatin|
16385331|NCT00004921|Drug|cyclophosphamide|
16385332|NCT00004921|Drug|melphalan|
16385333|NCT00004921|Drug|paclitaxel|
16385334|NCT00004921|Procedure|adjuvant therapy|
16385335|NCT00004921|Procedure|bone marrow ablation with stem cell support|
16385336|NCT00004921|Procedure|peripheral blood stem cell transplantation|
16385337|NCT00004920|Drug|cisplatin|
16385338|NCT00004920|Drug|raltitrexed|
16385339|NCT00004918|Biological|PR1 leukemia peptide vaccine|Given SC
16385340|NCT00004918|Drug|Montanide ISA 51 VG|Given SC
16385341|NCT00004918|Biological|sargramostim|Given SC
16385342|NCT00004918|Other|laboratory biomarker analysis|Correlative studies
16385343|NCT00004917|Biological|epoetin alfa|
16385344|NCT00004917|Drug|cisplatin|
16385345|NCT00004917|Radiation|radiation therapy|
16385346|NCT00004907|Drug|busulfan|
16385347|NCT00004907|Drug|cyclophosphamide|
16385348|NCT00004907|Drug|etoposide|
16385349|NCT00004907|Procedure|allogeneic bone marrow transplantation|
16385350|NCT00004907|Procedure|bone marrow ablation with stem cell support|
16385351|NCT00004907|Procedure|peripheral blood stem cell transplantation|
16385352|NCT00004907|Radiation|radiation therapy|
16385353|NCT00004899|Biological|filgrastim|
16385354|NCT00004899|Drug|busulfan|
16385355|NCT00004899|Drug|etoposide|
16385430|NCT00004231|Drug|cytarabine|
16385356|NCT00004899|Procedure|autologous bone marrow transplantation|
16385357|NCT00004896|Drug|busulfan|
16385358|NCT00004896|Drug|cyclophosphamide|
16385359|NCT00004896|Procedure|allogeneic bone marrow transplantation|
16385360|NCT00004896|Procedure|bone marrow ablation with stem cell support|
16385361|NCT00004896|Radiation|radiation therapy|
16385362|NCT00004891|Drug|chemotherapy|
16385363|NCT00004891|Procedure|computed tomography|
16385364|NCT00004891|Procedure|conventional surgery|
16385365|NCT00004891|Procedure|neoadjuvant therapy|
16385366|NCT00004891|Procedure|positron emission tomography|
16385367|NCT00004891|Procedure|radionuclide imaging|
16385368|NCT00004891|Radiation|fludeoxyglucose F 18|
16385369|NCT00004891|Radiation|radiation therapy|
16385370|NCT00004888|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16385371|NCT00004888|Drug|docetaxel|Given IV
16385372|NCT00004888|Biological|trastuzumab|Given IV
16385373|NCT00004888|Other|laboratory biomarker analysis|Correlative studies
16385374|NCT00004879|Biological|panitumumab|
16385375|NCT00004876|Drug|carboplatin|
16385376|NCT00004876|Drug|thalidomide|
16385377|NCT00004873|Drug|cisplatin|
16385378|NCT00004873|Drug|docetaxel|
16385379|NCT00004873|Drug|epirubicin hydrochloride|
16385380|NCT00004873|Drug|fluorouracil|
16385381|NCT00004871|Drug|azacitidine|
16385382|NCT00004871|Drug|sodium phenylbutyrate|
16385383|NCT00004867|Procedure|conventional surgery|
16385384|NCT00004867|Procedure|positron emission tomography|
16385385|NCT00004867|Procedure|radionuclide imaging|
16385386|NCT00004867|Radiation|fludeoxyglucose F 18|
16385387|NCT00004867|Drug|chemotherapy|
16385388|NCT00004867|Radiation|Radiotherapy|
16385389|NCT00004866|Drug|exatecan mesylate|
16385390|NCT00004859|Drug|carboplatin|Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
16385391|NCT00004859|Drug|paclitaxel|Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
16385392|NCT00004859|Drug|thalidomide|Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
16385393|NCT00004859|Radiation|radiation therapy|Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
16385394|NCT00004262|Procedure|conventional surgery|
16385395|NCT00004262|Radiation|3-dimensional conformal radiation therapy|
16385396|NCT00004262|Radiation|stereotactic radiosurgery|
16385397|NCT00004262|Drug|motexafin gadolinium|Given IV
16385398|NCT00004262|Procedure|magnetic resonance imaging|Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
16385399|NCT00004262|Procedure|spectroscopy|Undergo plasma-atomic emission spectroscopy (DCP-AES)
16385400|NCT00004259|Drug|BCNU 80mg/m2|BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).
16385401|NCT00004259|Drug|TMZ 200mg/m2|200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.
16385402|NCT00004259|Radiation|radiation therapy|1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
16385403|NCT00004259|Drug|CCNU|CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.
16385404|NCT00004259|Drug|BCNU 150mg/m2|BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).
16385405|NCT00004259|Drug|BCNU 200mg/m2|BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).
16385406|NCT00004259|Drug|TMZ 150mg/m2 six 6-week cycles|150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles
16385407|NCT00004259|Drug|TMZ 150mg/m2 six 8-week cycles|150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles
16385408|NCT00004250|Biological|dactinomycin|
16385409|NCT00004250|Drug|isolated limb perfusion|
16385410|NCT00004250|Drug|melphalan|
16385411|NCT00004245|Drug|sodium salicylate|
16385412|NCT00004244|Biological|recombinant interferon alfa|
16385413|NCT00004244|Biological|recombinant interleukin-12|
16385414|NCT00004241|Drug|tanespimycin|Given IV
16385415|NCT00004241|Other|pharmacological study|Correlative studies
16385416|NCT00004237|Drug|cyclophosphamide|
16385417|NCT00004237|Drug|doxorubicin hydrochloride|
16385418|NCT00004237|Drug|epirubicin hydrochloride|
16385419|NCT00004237|Drug|mitoxantrone hydrochloride|
16385420|NCT00004237|Drug|vinorelbine tartrate|
16385421|NCT00004237|Procedure|conventional surgery|
16385422|NCT00004237|Radiation|radiation therapy|
16385423|NCT00004234|Procedure|management of therapy complications|
16385424|NCT00004234|Radiation|radiation therapy|
16385425|NCT00004231|Biological|aldesleukin|
16385426|NCT00004231|Biological|filgrastim|
16385427|NCT00004231|Biological|recombinant interferon alfa|
16385428|NCT00004231|Drug|busulfan|
16385429|NCT00004231|Drug|cyclophosphamide|
16385431|NCT00004231|Drug|doxorubicin hydrochloride|
16385432|NCT00004231|Drug|leucovorin calcium|
16385433|NCT00004231|Drug|methotrexate|
16385434|NCT00004231|Drug|prednisone|
16385435|NCT00004231|Drug|teniposide|
16385436|NCT00004231|Drug|vincristine sulfate|
16385437|NCT00004231|Procedure|allogeneic bone marrow transplantation|
16385438|NCT00004231|Procedure|autologous bone marrow transplantation|
16385439|NCT00004231|Procedure|peripheral blood stem cell transplantation|
16385440|NCT00004228|Drug|asparaginase|Given IV
16385441|NCT00004228|Drug|cyclophosphamide|Given IV
16385442|NCT00004228|Drug|cytarabine|Given IV
16385443|NCT00004228|Drug|daunorubicin hydrochloride|Given IV
16385444|NCT00004228|Drug|dexamethasone|Given IV
16385445|NCT00004228|Drug|doxorubicin hydrochloride|Given IV
16385446|NCT00004228|Drug|leucovorin calcium|Given IV
16385447|NCT00004228|Drug|mercaptopurine|Given IV
16385448|NCT00004228|Drug|methotrexate|Given IV
16385449|NCT00004228|Drug|prednisone|Given IV
16385450|NCT00004228|Drug|thioguanine|Given PO
16385451|NCT00004228|Drug|vincristine sulfate|Given IV
16385452|NCT00004228|Radiation|radiation therapy|
16385453|NCT00004227|Biological|cetuximab|
16385454|NCT00004227|Procedure|conventional surgery|
16385455|NCT00004227|Radiation|radiation therapy|
16385456|NCT00004226|Radiation|radiation therapy|
16385457|NCT00004225|Biological|Ad5CMV-p53 gene|
16385458|NCT00004225|Radiation|radiation therapy|
16385459|NCT00004224|Drug|cyclophosphamide|
16385460|NCT00004224|Drug|etoposide|
16385461|NCT00004224|Drug|vincristine sulfate|
16385462|NCT00004224|Procedure|adjuvant therapy|
16385463|NCT00004224|Procedure|conventional surgery|
16385464|NCT00004224|Radiation|radiation therapy|
16385465|NCT00004218|Drug|chlorambucil|
16385466|NCT00004218|Drug|cyclophosphamide|
16385467|NCT00004218|Drug|doxorubicin hydrochloride|
16385468|NCT00004218|Drug|fludarabine phosphate|
16385469|NCT00004218|Drug|prednisolone|
16385470|NCT00004218|Drug|vincristine sulfate|
16385471|NCT00004212|Biological|filgrastim|
16385472|NCT00004212|Drug|exatecan mesylate|
16385473|NCT00004210|Other|loss of heterozygosity analysis|
16385474|NCT00004210|Other|microsatellite instability analysis|
16385475|NCT00004210|Other|mutation analysis|
16385476|NCT00004210|Other|counseling intervention|
16385477|NCT00004208|Drug|ATG + CSA|Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
16385478|NCT00004208|Behavioral|Supportive care|Patients randomized to this arm will be treated as outpatients.
16385479|NCT00004205|Drug|letrozole|Letrozole 2.5 mg daily oral administration.
16385480|NCT00004205|Drug|tamoxifen citrate|Tamoxifen 20 mg daily oral administration.
16385481|NCT00004196|Biological|recombinant interferon alfa|
16385482|NCT00004196|Procedure|lymphangiography|
16385483|NCT00004196|Drug|Observation|
16385484|NCT00004189|Biological|filgrastim|
16385485|NCT00004189|Drug|becatecarin|
16385486|NCT00004189|Drug|cisplatin|
16385487|NCT00004188|Biological|filgrastim|Given IV
16385488|NCT00004188|Drug|carboplatin|Given IV
16385489|NCT00004188|Drug|cisplatin|Given IV
16385490|NCT00004188|Drug|cyclophosphamide|Given IV
16385491|NCT00004188|Drug|doxorubicin hydrochloride|Given IV
16385492|NCT00004188|Drug|etoposide|Given IV
16385493|NCT00004188|Drug|isotretinoin|Given IV
16385494|NCT00004188|Drug|melphalan|Given IV
16385495|NCT00004188|Drug|topotecan hydrochloride|Given IV
16385496|NCT00004188|Drug|vincristine sulfate|Given IV
16385497|NCT00004188|Procedure|autologous bone marrow transplantation|
16385498|NCT00004188|Procedure|bone marrow ablation with stem cell support|
16385499|NCT00004188|Procedure|conventional surgery|All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
16385500|NCT00004188|Procedure|peripheral blood stem cell transplantation|
16385501|NCT00004188|Radiation|radiation therapy|After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
16385502|NCT00004181|Drug|busulfan|
16385503|NCT00004181|Drug|cyclophosphamide|
16385504|NCT00004181|Procedure|allogeneic bone marrow transplantation|
16385505|NCT00004181|Radiation|radiation therapy|
16385506|NCT00004179|Biological|rituximab|
16385507|NCT00004179|Drug|CHOP regimen|
16385508|NCT00004179|Drug|cyclophosphamide|
16385509|NCT00004179|Drug|doxorubicin hydrochloride|
16385510|NCT00004179|Drug|prednisone|
16385511|NCT00004179|Drug|vincristine sulfate|
16385512|NCT00004173|Drug|oxaliplatin|
16385513|NCT00004173|Drug|paclitaxel|
16385514|NCT00004165|Biological|filgrastim|
16385515|NCT00004165|Drug|melphalan|
16385516|NCT00004165|Procedure|peripheral blood stem cell transplantation|
16385517|NCT00004154|Drug|Fenretinide|200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
16385518|NCT00004154|Other|Placebo|Two placebo capsules for 25 days of 28 day cycle.
16385519|NCT00004153|Genetic|reverse transcriptase-polymerase chain reaction|
16385520|NCT00004153|Procedure|sentinel lymph node biopsy|
16385521|NCT00004150|Drug|fluorouracil|
16385522|NCT00004150|Drug|leucovorin calcium|
16385523|NCT00004150|Procedure|adjuvant therapy|
16385524|NCT00004149|Drug|arsenic trioxide|
16385525|NCT00004147|Drug|incyclinide|
16385526|NCT00004144|Drug|bryostatin 1|
16385527|NCT00004144|Drug|gemcitabine hydrochloride|
16385528|NCT00004143|Drug|Campath, Chemo and/or TBI Allo SCT|Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.
16385530|NCT00004141|Drug|dacarbazine|
16385531|NCT00004141|Drug|Granulocyte-macrophage colony-stimulating factor|
16385532|NCT00004138|Procedure|positron emission tomography|
16385533|NCT00004138|Procedure|radionuclide imaging|
16385534|NCT00004138|Radiation|fludeoxyglucose F 18|
16385535|NCT00004135|Biological|filgrastim|
16385536|NCT00004135|Biological|therapeutic allogeneic lymphocytes|
16385537|NCT00004135|Drug|cyclophosphamide|
16385538|NCT00004135|Drug|fludarabine phosphate|
16385539|NCT00004135|Procedure|peripheral blood stem cell transplantation|
16385540|NCT00004129|Radiation|brachytherapy|
16385541|NCT00004129|Radiation|phosphorus P32|
16385542|NCT00004128|Biological|aldesleukin|
16385543|NCT00004128|Biological|filgrastim|
16385544|NCT00004128|Drug|busulfan|
16385545|NCT00004128|Drug|cyclophosphamide|
16385546|NCT00004128|Drug|cytarabine|
16385547|NCT00004128|Drug|daunorubicin hydrochloride|
16385548|NCT00004128|Drug|etoposide|
16385549|NCT00004128|Procedure|autologous bone marrow transplantation|
16385550|NCT00004128|Procedure|peripheral blood stem cell transplantation|
16385551|NCT00004128|Radiation|radiation therapy|
16385552|NCT00004124|Drug|bicalutamide|
16385553|NCT00004124|Drug|goserelin|
16385554|NCT00004124|Drug|mitoxantrone hydrochloride|
16385555|NCT00004124|Drug|prednisone|
16385556|NCT00004115|Radiation|yttrium Y 90 monoclonal antibody HMFG1|
16385557|NCT00004110|Biological|monoclonal antibody 3F8|
16385558|NCT00004110|Drug|etoposide|
16385559|NCT00004110|Drug|isotretinoin|
16385560|NCT00004106|Drug|temozolomide|Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
16385561|NCT00004103|Drug|cisplatin|
16385562|NCT00004103|Drug|floxuridine|
16385563|NCT00004103|Drug|irinotecan hydrochloride|
16385564|NCT00004103|Procedure|adjuvant therapy|
16385565|NCT00004103|Procedure|conventional surgery|
16385566|NCT00004103|Procedure|neoadjuvant therapy|
16385567|NCT00004099|Drug|cisplatin|
16385568|NCT00004099|Drug|fluorouracil|
16385569|NCT00004099|Drug|leucovorin calcium|
16385570|NCT00004099|Procedure|neoadjuvant therapy|
16385571|NCT00004092|Biological|filgrastim|Given IV or subcutaneously
16385572|NCT00004092|Drug|carboplatin|Given IV
16385573|NCT00004092|Drug|cyclophosphamide|Given IV
16385574|NCT00004092|Drug|doxorubicin hydrochloride|Given IV
16385575|NCT00004092|Drug|paclitaxel|Given IV
16385576|NCT00004092|Drug|thiotepa|Given IV
16385577|NCT00004092|Procedure|peripheral blood stem cell transplantation|Patients receive autologous peripheral blood stem cells
16385578|NCT00004088|Biological|filgrastim|
16385579|NCT00004088|Biological|recombinant interferon alfa|
16385580|NCT00004088|Drug|busulfan|
16385581|NCT00004088|Drug|cyclophosphamide|
16385582|NCT00004088|Drug|melphalan|
16385583|NCT00004088|Drug|pamidronate disodium|
16385584|NCT00004088|Drug|thalidomide|
16385585|NCT00004088|Procedure|peripheral blood stem cell transplantation|
16385586|NCT00004081|Drug|docetaxel|
16385587|NCT00004077|Drug|cisplatin|
16385588|NCT00004077|Drug|ifosfamide|
16385589|NCT00004077|Drug|paclitaxel|
16385590|NCT00004075|Drug|tanespimycin|
16385591|NCT00004072|Drug|O6-benzylguanine|Patients receive O6-benzylguanine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response.
16385592|NCT00004072|Drug|carmustine|Followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response.
16385593|NCT00004067|Biological|herceptin|4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
16385594|NCT00004067|Drug|adriamycin|60 mg/m2 IV push every 21 days for 4 cycles.
16385595|NCT00004067|Drug|cyclophosphamide|600 mg/m2 IV every 21 days for 4 cycles
16385596|NCT00004067|Drug|taxol|175 mg/m2 IV every 21 days for 4 cycles
16385597|NCT00004066|Biological|filgrastim|
16385598|NCT00004066|Drug|docetaxel|
16385599|NCT00004066|Drug|gemcitabine hydrochloride|
16385600|NCT00004065|Drug|tanespimycin|
16385601|NCT00004063|Biological|recombinant interferon alfa|
16385602|NCT00004063|Drug|cisplatin|
16385603|NCT00004063|Drug|gemcitabine hydrochloride|
16385604|NCT00004063|Procedure|hyperthermia treatment|
16385605|NCT00004058|Drug|tetradecanoylphorbol acetate|
16385606|NCT00004054|Drug|bicalutamide|Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
16385607|NCT00004054|Drug|estramustine phosphate sodium|280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles
16385608|NCT00004054|Drug|etoposide|50 mg/m^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles
16385609|NCT00004054|Drug|flutamide|Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.
16385610|NCT00004054|Drug|paclitaxel|135 mg/m^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles
16385611|NCT00004054|Drug|Luteinizing hormone releasing hormone [LHRH] agonist|Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months
16385612|NCT00004054|Radiation|Radiation therapy|Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.
16385613|NCT00004054|Drug|warfarin|To keep international normalized ratio (INR) > 1.5 and < 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
16385711|NCT00003912|Drug|cisplatin|
16385614|NCT00004031|Biological|rituximab|375 mg/m2 IV every 21 days
16385615|NCT00004031|Drug|CHOP regimen|
16385616|NCT00004031|Drug|carmustine|
16385617|NCT00004031|Drug|cyclophosphamide|
16385618|NCT00004031|Drug|doxorubicin hydrochloride|
16385619|NCT00004031|Drug|etoposide|
16385620|NCT00004031|Drug|prednisone|
16385621|NCT00004031|Drug|vincristine sulfate|
16385622|NCT00004031|Procedure|bone marrow ablation with stem cell support|
16385623|NCT00004031|Procedure|peripheral blood stem cell transplantation|
16385624|NCT00004031|Radiation|radiation therapy|
16385625|NCT00004028|Drug|carmustine|
16385626|NCT00004028|Procedure|conventional surgery|
16385627|NCT00004024|Biological|aldesleukin|
16385628|NCT00004024|Biological|autologous tumor cell vaccine|
16385629|NCT00004024|Biological|muromonab-CD3|
16385630|NCT00004024|Biological|sargramostim|
16385631|NCT00004024|Biological|therapeutic autologous lymphocytes|
16385632|NCT00004024|Procedure|surgical procedure|
16385633|NCT00004024|Radiation|radiation therapy|
16385634|NCT00004017|Procedure|conventional surgery|
16385635|NCT00004017|Radiation|iodine I 131 monoclonal antibody TNT-1/B|
16385636|NCT00004015|Drug|sodium borocaptate|
16385637|NCT00004015|Procedure|adjuvant therapy|
16385638|NCT00004011|Drug|carboplatin|
16385639|NCT00004011|Drug|paclitaxel|
16385640|NCT00004011|Procedure|conventional surgery|
16385641|NCT00004005|Drug|fluorouracil|
16385642|NCT00004005|Drug|irinotecan hydrochloride|
16385643|NCT00004005|Drug|leucovorin calcium|
16385644|NCT00004005|Procedure|conventional surgery|
16385645|NCT00004005|Radiation|radiation therapy|
16385646|NCT00004001|Drug|docetaxel|
16385647|NCT00004001|Drug|estramustine|
16385648|NCT00004001|Drug|mitoxantrone|
16385649|NCT00004001|Drug|prednisone|
16385650|NCT00003994|Procedure|therapeutic conventional surgery|Undergo surgical resection
16385651|NCT00003994|Drug|cisplatin|Given IV
16385652|NCT00003994|Drug|vincristine sulfate|Given IV
16385653|NCT00003994|Drug|fluorouracil|Given IV
16385654|NCT00003994|Drug|amifostine trihydrate|Given IV
16385655|NCT00003994|Drug|carboplatin|Given IV
16385656|NCT00003993|Biological|aldesleukin|
16385657|NCT00003993|Drug|bryostatin 1|
16385658|NCT00003981|Drug|indisulam|
16385659|NCT00003979|Drug|CHS 828|
16385660|NCT00003977|Biological|human papillomavirus 16 E7 peptide|
16385661|NCT00003977|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16385662|NCT00003970|Drug|irinotecan hydrochloride|Given IV
16385663|NCT00003969|Drug|tanespimycin|
16385664|NCT00003966|Drug|defibrotide|
16385665|NCT00003963|Biological|rituximab|Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Week 5-8: Rituxan given every 2 weeks. Week 9-12: Schedule same as week 5-8.
16385666|NCT00003963|Drug|vinorelbine ditartrate|"Week 1-4: Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose.
~Week 5-8: Vinorelbine given weekly x3, with one week off. Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated."
16385667|NCT00003961|Biological|sargramostim|
16385668|NCT00003958|Biological|dactinomycin|Given IV
16385669|NCT00003958|Drug|vincristine sulfate|Given IV
16385670|NCT00003958|Drug|cyclophosphamide|Given IV
16385671|NCT00003958|Procedure|therapeutic conventional surgery|Undergo surgery
16385672|NCT00003958|Radiation|radiation therapy|Undergo radiotherapy
16385673|NCT00003958|Drug|topotecan hydrochloride|Given IV
16385674|NCT00003958|Biological|filgrastim|Given SC
16385675|NCT00003958|Biological|sargramostim|Given SC
16385676|NCT00003958|Other|laboratory biomarker analysis|Correlative studies
16385677|NCT00003955|Biological|dactinomycin|
16385678|NCT00003955|Biological|filgrastim|
16385679|NCT00003955|Biological|pegfilgrastim|
16385680|NCT00003955|Biological|sargramostim|
16385681|NCT00003955|Drug|cyclophosphamide|
16385682|NCT00003955|Drug|irinotecan hydrochloride|
16385683|NCT00003955|Drug|vincristine sulfate|
16385684|NCT00003955|Radiation|radiation therapy|
16385685|NCT00003945|Drug|cisplatin|
16385686|NCT00003945|Drug|topotecan hydrochloride|
16385687|NCT00003941|Biological|bleomycin sulfate|
16385688|NCT00003941|Biological|filgrastim|
16385689|NCT00003941|Drug|cisplatin|
16385690|NCT00003941|Drug|etoposide|
16385691|NCT00003941|Drug|ifosfamide|
16385692|NCT00003941|Procedure|bone marrow ablation with stem cell support|
16385693|NCT00003941|Procedure|peripheral blood stem cell transplantation|
16385694|NCT00003938|Drug|liposomal amphotericin B|
16385695|NCT00003934|Drug|tretinoin|Given orally
16385696|NCT00003934|Drug|daunorubicin hydrochloride|Given IV
16385697|NCT00003934|Drug|cytarabine|Given IV
16385698|NCT00003934|Drug|mercaptopurine|Given IV
16385699|NCT00003934|Drug|methotrexate|Given IV
16385700|NCT00003934|Drug|arsenic trioxide|Given IV
16385701|NCT00003928|Drug|cisplatin|Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
16385702|NCT00003928|Drug|gemcitabine hydrochloride|Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
16385703|NCT00003913|Biological|anti-thymocyte globulin|
16385704|NCT00003913|Biological|filgrastim|
16385705|NCT00003913|Drug|busulfan|
16385706|NCT00003913|Drug|cyclophosphamide|
16385707|NCT00003913|Drug|methylprednisolone|
16385708|NCT00003913|Procedure|umbilical cord blood transplantation|
16385709|NCT00003913|Radiation|radiation therapy|
16385710|NCT00003912|Drug|carboplatin|
16385712|NCT00003912|Drug|doxorubicin hydrochloride|
16385713|NCT00003912|Procedure|conventional surgery|
16385714|NCT00003910|Drug|Cyclophosphamide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule. In patients showing a partial response, but not a CR, the maximum period of therapy was 1 year.
16385715|NCT00003910|Drug|Methotrexate|Initial treatment consisted of MTX given orally at 10 mg/m2 in divided doses once weekly.
16385716|NCT00003910|Drug|Prednisone|Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days.
16385717|NCT00003909|Drug|motexafin gadolinium|Given IV
16385718|NCT00003909|Radiation|radiation therapy|Undergo radiation therapy
16385719|NCT00003909|Other|pharmacological study|Correlatives studies
16385720|NCT00003906|Drug|Raloxifene|60 mg/day plus placebo for 5 years
16385721|NCT00003906|Drug|Tamoxifen|20 mg/day plus placebo for 5 years
16385722|NCT00003903|Procedure|management of therapy complications|
16385723|NCT00003902|Drug|capecitabine|
16385724|NCT00003902|Drug|vinorelbine tartrate|
16385725|NCT00003901|Other|immunohistochemistry staining method|
16385726|NCT00003901|Procedure|biopsy|
16385727|NCT00003901|Procedure|surgery|
16385728|NCT00003896|Drug|cisplatin|
16385729|NCT00003896|Drug|liposomal doxorubicin|
16385730|NCT00003896|Drug|paclitaxel|
16385731|NCT00003893|Drug|CMF regimen|
16385732|NCT00003893|Drug|cyclophosphamide|
16385733|NCT00003893|Drug|doxorubicin hydrochloride|
16385734|NCT00003893|Drug|epirubicin hydrochloride|
16385735|NCT00003893|Drug|fluorouracil|
16385736|NCT00003893|Drug|methotrexate|
16385737|NCT00003893|Drug|mitomycin C|
16385738|NCT00003893|Drug|mitoxantrone hydrochloride|
16385739|NCT00003893|Procedure|adjuvant therapy|
16385740|NCT00003893|Radiation|radiation therapy|
16385741|NCT00003878|Drug|polifeprosan 20 with carmustine implant|
16385742|NCT00003878|Procedure|conventional surgery|
16385743|NCT00003875|Drug|busulfan|Given PO or IV
16385744|NCT00003875|Drug|etoposide|Given IV
16385745|NCT00003875|Biological|aldesleukin|Given SC
16385746|NCT00003875|Procedure|peripheral blood stem cell transplantation|Undergo autologous or syngeneic stem cell rescue
16385747|NCT00003869|Drug|carboxyamidotriazole|Given PO
16385748|NCT00003869|Other|placebo|Given PO
16385749|NCT00003869|Procedure|quality-of-life assessment|Ancillary studies
16385750|NCT00003869|Other|laboratory biomarker analysis|Correlative studies
16385751|NCT00003865|Drug|toremifene|
16385752|NCT00003863|Genetic|comparative genomic hybridization|
16385753|NCT00003863|Genetic|cytogenetic analysis|
16385754|NCT00003863|Genetic|fluorescence in situ hybridization|
16385755|NCT00003863|Genetic|gene rearrangement analysis|
16385756|NCT00003862|Drug|cisplatin|
16385757|NCT00003862|Drug|fluorouracil|
16385758|NCT00003862|Drug|leucovorin calcium|
16385759|NCT00003862|Drug|paclitaxel|
16385760|NCT00003862|Procedure|conventional surgery|
16385761|NCT00003862|Procedure|neoadjuvant therapy|
16385762|NCT00003862|Radiation|radiation therapy|
16385763|NCT00003861|Other|laboratory biomarker analysis|
16385764|NCT00003857|Drug|tamoxifen citrate|
16385765|NCT00003857|Procedure|adjuvant therapy|
16385766|NCT00003857|Radiation|radiation therapy|
16385767|NCT00003855|Procedure|axillary lymph node dissection|
16385768|NCT00003855|Radiation|whole breast irradiation|
16385769|NCT00003854|Other|immunohistochemistry staining method|
16385770|NCT00003854|Procedure|lymphangiography|
16385771|NCT00003854|Procedure|sentinel lymph node biopsy|
16385772|NCT00003854|Procedure|therapeutic conventional surgery|
16385773|NCT00003854|Radiation|whole breast irradiation|
16385774|NCT00003851|Biological|proteolytic enzymes|
16385775|NCT00003851|Drug|gemcitabine hydrochloride|
16385776|NCT00003851|Procedure|Gonzalez regimen|
16385777|NCT00003843|Drug|irinotecan hydrochloride|
16385778|NCT00003843|Genetic|mutation analysis|
16385779|NCT00003843|Genetic|polymorphism analysis|
16385780|NCT00003838|Other|T-cell replete PBPC allograft|Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m2 intravenously (IV) over 30 minutes daily x 5 days with or without ATG followed by a PBPC graft targeted to deliver >5x10^6 CD34+ cells /kg.
16385781|NCT00003837|Drug|nelarabine|
16385782|NCT00003833|Genetic|DNA stability analysis|
16385783|NCT00003833|Genetic|gene mapping|
16385784|NCT00003831|Procedure|conventional surgery|
16385785|NCT00003820|Drug|Rituximab|Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.
16385786|NCT00003816|Biological|anti-thymocyte globulin|Given IV
16385787|NCT00003816|Drug|busulfan|Given IV
16385788|NCT00003816|Drug|carboplatin|Given IV
16385789|NCT00003816|Drug|cyclophosphamide|Given IV
16385790|NCT00003816|Drug|etoposide|Given IV
16385791|NCT00003816|Drug|fludarabine phosphate|Given IV
16385792|NCT00003816|Drug|melphalan|Given IV
16385793|NCT00003816|Drug|thiotepa|Given IV
16385794|NCT00003816|Radiation|total-body irradiation|Given twice daily for 3 days
16385795|NCT00003815|Biological|bleomycin sulfate|
16385796|NCT00003815|Drug|carmustine|
16385797|NCT00003815|Drug|cyclophosphamide|
16385798|NCT00003815|Drug|cytarabine|
16385799|NCT00003815|Drug|doxorubicin hydrochloride|
16385800|NCT00003815|Drug|etoposide|
16385801|NCT00003815|Drug|melphalan|
16385802|NCT00003815|Drug|prednisolone|
16385803|NCT00003815|Drug|vincristine sulfate|
16385804|NCT00003815|Procedure|autologous bone marrow transplantation|
16385805|NCT00003815|Radiation|radiation therapy|
16385806|NCT00003803|Drug|cisplatin|
16385807|NCT00003803|Drug|gemcitabine hydrochloride|
16385808|NCT00003803|Radiation|radiation therapy|
16385809|NCT00003800|Other|immunohistochemistry staining method|
16385810|NCT00003800|Other|laboratory biomarker analysis|
16385811|NCT00003800|Procedure|radionuclide imaging|
16385812|NCT00003799|Drug|fluorouracil|Given IV
16385813|NCT00003799|Drug|oxaliplatin|Given IV
16385814|NCT00003799|Radiation|radiation therapy|Undergo radiotherapy
16385815|NCT00003799|Drug|leucovorin calcium|Given IV
16385816|NCT00003799|Procedure|therapeutic conventional surgery|Undergo surgery
16385817|NCT00003796|Drug|irofulven|
16385818|NCT00003793|Genetic|clonality analysis|
16385819|NCT00003793|Genetic|microsatellite instability analysis|
16385820|NCT00003793|Genetic|mutation analysis|
16385821|NCT00003789|Drug|isolated limb perfusion|Undergo isolated limb perfusion
16385822|NCT00003789|Drug|melphalan|Given via limb perfusion
16385823|NCT00003789|Biological|recombinant tumor necrosis factor family protein|Given via slow injection into the arterial line
16385824|NCT00003789|Other|pharmacological study|Correlative studies
16385825|NCT00003789|Other|laboratory biomarker analysis|Correlative studies
16385826|NCT00003788|Drug|carmustine|
16385827|NCT00003788|Drug|lomustine|
16385828|NCT00003788|Drug|porfimer sodium|
16385829|NCT00003788|Drug|procarbazine hydrochloride|
16385830|NCT00003788|Procedure|neoadjuvant therapy|
16385831|NCT00003788|Procedure|surgical procedure|
16385832|NCT00003788|Radiation|radiation therapy|
16385833|NCT00003782|Drug|cyclophosphamide|Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
16385834|NCT00003782|Drug|docetaxel|Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
16385835|NCT00003782|Drug|doxorubicin|Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
16385836|NCT00003771|Biological|therapeutic estradiol|
16385837|NCT00003771|Drug|norethindrone acetate|
16385838|NCT00003764|Drug|cyclophosphamide|
16385839|NCT00003764|Drug|fludarabine phosphate|
16385840|NCT00003753|Drug|dexamethasone|
16385841|NCT00003753|Drug|floxuridine|
16385842|NCT00003753|Drug|irinotecan hydrochloride|
16385843|NCT00003753|Procedure|adjuvant therapy|
16385844|NCT00003753|Procedure|conventional surgery|
16385845|NCT00003750|Biological|hu14.18-IL2 fusion protein|
16385846|NCT00003749|Procedure|adjuvant therapy|
16385847|NCT00003749|Procedure|conventional surgery|
16385848|NCT00003749|Radiation|brachytherapy|
16385849|NCT00003749|Radiation|radiation therapy|
16385850|NCT00003746|Drug|2-chlorodeoxyadenosine (CDA) daily|Daily administration
16385851|NCT00003746|Drug|2-chlorodeoxyadenosine weekly|Weekly administration
16385852|NCT00003745|Drug|topotecan hydrochloride|
16385853|NCT00003744|Drug|gemcitabine|
16385854|NCT00003741|Biological|monoclonal antibody HeFi-1|
16385855|NCT00003739|Biological|filgrastim|
16385856|NCT00003737|Drug|becatecarin|
16385857|NCT00003732|Drug|carboplatin|
16385858|NCT00003732|Drug|paclitaxel|
16385859|NCT00003732|Drug|topotecan hydrochloride|
16385860|NCT00003730|Drug|fluorouracil|
16385861|NCT00003730|Drug|vinorelbine tartrate|
16385862|NCT00003728|Drug|asparaginase|
16385863|NCT00003728|Drug|cyclophosphamide|
16385864|NCT00003728|Drug|cytarabine|
16385865|NCT00003728|Drug|daunorubicin hydrochloride|
16385866|NCT00003728|Drug|dexamethasone|
16385867|NCT00003728|Drug|doxorubicin hydrochloride|
16385868|NCT00003728|Drug|etoposide|
16385869|NCT00003728|Drug|leucovorin calcium|
16385870|NCT00003728|Drug|mercaptopurine|
16385871|NCT00003728|Drug|methotrexate|
16385872|NCT00003728|Drug|methylprednisolone|
16385873|NCT00003728|Drug|mitoxantrone hydrochloride|
16385874|NCT00003728|Drug|prednisolone|
16385875|NCT00003728|Drug|therapeutic hydrocortisone|
16385876|NCT00003728|Drug|thioguanine|
16385877|NCT00003728|Drug|vincristine sulfate|
16385878|NCT00003728|Drug|vindesine|
16385879|NCT00003728|Procedure|allogeneic bone marrow transplantation|
16385880|NCT00003728|Procedure|peripheral blood stem cell transplantation|
16385881|NCT00003727|Biological|filgrastim|
16385882|NCT00003727|Biological|recombinant interferon alfa|
16385883|NCT00003727|Biological|sargramostim|
16385884|NCT00003727|Biological|therapeutic autologous lymphocytes|
16385885|NCT00003727|Drug|carmustine|
16385886|NCT00003727|Drug|cyclophosphamide|
16385887|NCT00003727|Drug|etoposide|
16385888|NCT00003727|Drug|gemcitabine hydrochloride|
16385889|NCT00003727|Drug|melphalan|
16385890|NCT00003727|Procedure|bone marrow ablation with stem cell support|
16385891|NCT00003727|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16385892|NCT00003702|Biological|Dactinomycin|Given IV
16385893|NCT00003702|Drug|Methotrexate|Given intramuscularly
16385894|NCT00003696|Drug|carboplatin|
16385895|NCT00003696|Drug|cyclophosphamide|
16385896|NCT00003696|Drug|doxorubicin hydrochloride|
16385897|NCT00003696|Drug|etoposide|
16385898|NCT00003696|Drug|paclitaxel|
16385899|NCT00003690|Drug|alvocidib|
16385900|NCT00003690|Drug|carboplatin|
16385901|NCT00003690|Drug|cisplatin|
16385902|NCT00003688|Biological|dactinomycin|
16385903|NCT00003687|Drug|dextromethorphan hydrobromide|
16385904|NCT00003687|Drug|morphine sulfate|
16385905|NCT00003678|Drug|tamoxifen citrate|
16385906|NCT00003678|Procedure|adjuvant therapy|
16385907|NCT00003659|Biological|filgrastim|Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients > 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.
16385908|NCT00003659|Biological|rituximab|Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.
16385909|NCT00003659|Drug|cyclophosphamide|Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.
16385910|NCT00003659|Drug|fludarabine phosphate|Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
16385911|NCT00003658|Biological|filgrastim|
16385912|NCT00003658|Biological|rituximab|
16385913|NCT00003658|Drug|cyclophosphamide|
16385914|NCT00003658|Drug|pentostatin|
16385915|NCT00003656|Biological|recombinant interferon alfa|
16385916|NCT00003656|Drug|tretinoin liposome|
16385917|NCT00003653|Drug|bicalutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385918|NCT00003653|Drug|buserelin|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385919|NCT00003653|Drug|cyproterone acetate|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385920|NCT00003653|Drug|flutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385921|NCT00003653|Drug|goserelin|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385922|NCT00003653|Drug|leuprolide acetate|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385923|NCT00003653|Drug|nilutamide|"Patients on the IAS arm should receive a minimum of 4 weeks of antiandrogen and a total of 8 months of LHRH analog during each on-treatment interval. The dose and frequency of LHRH treatment will be determined by the drug being administered (Appendix IX). Patients on the IAS arm should not be given an LHRH analog injection at the end of month 8 unless the patient is transferred to continuous treatment as per protocol upon completion of the 8 month intermittent treatment.
~Patients may be treated with any commercially available LHRH analog and antiandrogen during or after protocol treatment (Appendix IX). Patients may switch drugs at any time during or after protocol treatment. The dose and schedule of treatment will depend on the agent used. Patients should continue to receive hormone therapy without interruption until hormone resistance has been documented"
16385924|NCT00003652|Drug|cisplatin|
16385925|NCT00003652|Drug|fluorouracil|
16385926|NCT00003652|Procedure|neoadjuvant therapy|
16385927|NCT00003652|Radiation|radiation therapy|
16385928|NCT00003650|Drug|asparaginase|
16385929|NCT00003650|Drug|cyclophosphamide|
16385930|NCT00003650|Drug|cytarabine|
16385931|NCT00003650|Drug|daunorubicin hydrochloride|
16385932|NCT00003650|Drug|dexamethasone|
16385933|NCT00003650|Drug|etoposide|
16385934|NCT00003650|Drug|mercaptopurine|
16385935|NCT00003650|Drug|methotrexate|
16385936|NCT00003650|Drug|methylprednisolone|
16385937|NCT00003650|Drug|mitoxantrone hydrochloride|
16385938|NCT00003650|Drug|prednisone|
16385939|NCT00003650|Drug|vincristine sulfate|
16385940|NCT00003650|Radiation|radiation therapy|
16385941|NCT00003644|Drug|carboplatin|
16385942|NCT00003644|Drug|paclitaxel|
16385943|NCT00003643|Biological|bleomycin sulfate|
16385944|NCT00003643|Biological|filgrastim|
16385945|NCT00003643|Drug|cisplatin|
16385946|NCT00003643|Drug|etoposide|
16385947|NCT00003643|Drug|paclitaxel|
16385948|NCT00003641|Biological|interferon alfa-2b|Given IV
16385949|NCT00003641|Other|observation|Patients undergo observation for 4 weeks.
16385950|NCT00003637|Drug|cisplatin|
16385951|NCT00003637|Drug|fluorouracil|
16385952|NCT00003637|Radiation|radiation therapy|
16385953|NCT00003636|Drug|carboplatin|
16385954|NCT00003636|Drug|cisplatin|
16385955|NCT00003636|Procedure|conventional surgery|
16385956|NCT00003636|Procedure|neoadjuvant therapy|
16385957|NCT00003633|Drug|docetaxel|
16385958|NCT00003633|Drug|estramustine phosphate sodium|
16385959|NCT00003633|Drug|mitoxantrone hydrochloride|
16385960|NCT00003633|Drug|prednisone|
16385961|NCT00003631|Biological|filgrastim|
16385962|NCT00003631|Drug|carboplatin|
16385963|NCT00003631|Drug|carmustine|
16385964|NCT00003631|Drug|cyclophosphamide|
16385965|NCT00003631|Drug|cytarabine|
16385966|NCT00003631|Drug|etoposide|
16385967|NCT00003631|Drug|ifosfamide|
16385968|NCT00003631|Drug|melphalan|
16385969|NCT00003631|Procedure|bone marrow ablation with stem cell support|
16385970|NCT00003631|Procedure|peripheral blood stem cell transplantation|
16385971|NCT00003631|Radiation|radiation therapy|
16385972|NCT00003613|Drug|O6-benzylguanine|Given IV
16385973|NCT00003613|Drug|carmustine|Given topically
16385974|NCT00003613|Other|laboratory biomarker analysis|Correlative studies
16385975|NCT00003612|Biological|trastuzumab|
16385976|NCT00003612|Drug|carboplatin|
16385977|NCT00003612|Drug|paclitaxel|
16385978|NCT00003611|Drug|acitretin|
16385979|NCT00003611|Other|placebo|
16385980|NCT00003607|Radiation|radiation therapy|
16385981|NCT00003603|Drug|cyclophosphamide|
16385982|NCT00003603|Drug|dexamethasone|
16385983|NCT00003603|Drug|idarubicin|
16385984|NCT00003603|Drug|lomustine|
16385985|NCT00003603|Drug|melphalan|
16385986|NCT00003603|Drug|prednisolone|
16385987|NCT00003602|Drug|cytarabine|
16385988|NCT00003602|Drug|etoposide|
16385989|NCT00003602|Drug|idarubicin|
16385990|NCT00003602|Drug|mitoxantrone hydrochloride|
16385991|NCT00003596|Drug|cisplatin|
16385992|NCT00003596|Drug|fluorouracil|
16385993|NCT00003596|Drug|mitomycin C|
16385994|NCT00003596|Radiation|radiation therapy|
16385995|NCT00003593|Drug|asparaginase|Given IV
16385996|NCT00003593|Drug|cytarabine|Given IT
16385997|NCT00003593|Drug|daunorubicin hydrochloride|Given IV
16385998|NCT00003593|Drug|methotrexate|Given IV
16385999|NCT00003593|Drug|therapeutic hydrocortisone|Given IT
16386000|NCT00003593|Drug|thioguanine|Given IV
16386001|NCT00003590|Drug|hydroxyurea|20 mg/kg/day PO
16386002|NCT00003577|Drug|CMF regimen|
16386003|NCT00003577|Drug|cyclophosphamide|
16386004|NCT00003577|Drug|epirubicin hydrochloride|
16386005|NCT00003577|Drug|fluorouracil|
16386006|NCT00003577|Drug|methotrexate|
16386007|NCT00003577|Procedure|adjuvant therapy|
16386008|NCT00003577|Radiation|radiation therapy|
16386009|NCT00003576|Drug|cisplatin|
16386010|NCT00003576|Drug|fluorouracil|
16386011|NCT00003576|Procedure|surgical procedure|
16386012|NCT00003576|Radiation|radiation therapy|
16386013|NCT00003569|Drug|cisplatin|
16386014|NCT00003569|Drug|dimesna|
16386015|NCT00003569|Drug|paclitaxel|
16386016|NCT00003568|Biological|aldesleukin|
16386017|NCT00003568|Biological|gp100 antigen|
16386018|NCT00003568|Biological|incomplete Freund's adjuvant|
16386019|NCT00003567|Biological|filgrastim|Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).
16386020|NCT00003567|Biological|sargramostim|Patients receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).
16386021|NCT00003567|Biological|therapeutic autologous lymphocytes|
16386022|NCT00003567|Drug|O6-benzylguanine|Patients receive O6-benzylguanine (BG) IV over 1 hour every 6 weeks for 5 courses. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.
16386023|NCT00003567|Drug|carmustine|Patients receive carmustine IV over 1 hour every 6 weeks for 5 courses.Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.
16386024|NCT00003567|Drug|temozolomide|Four weeks after the completion of BG and carmustine, patients receive temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.
16386427|NCT00003053|Drug|cisplatin|
16386025|NCT00003567|Procedure|in vitro-treated peripheral blood stem cell transplantation|Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.
16386026|NCT00003566|Procedure|videothoracoscopy|
16386027|NCT00003565|Drug|docetaxel|
16386028|NCT00003560|Drug|carboplatin|
16386029|NCT00003560|Drug|docetaxel|
16386030|NCT00003558|Drug|carboplatin|
16386031|NCT00003558|Drug|etoposide|
16386032|NCT00003558|Drug|fluorouracil|
16386033|NCT00003558|Drug|leucovorin calcium|
16386034|NCT00003558|Drug|paclitaxel|
16386035|NCT00003553|Other|HLA Matched Peripheral BLood Stem Cells|Cell Product
16386036|NCT00003538|Biological|graft versus host disease prophylaxis/therapy|
16386037|NCT00003538|Procedure|allogeneic bone marrow transplantation|
16386038|NCT00003537|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386039|NCT00003536|Drug|antineoplaston A10|
16386040|NCT00003536|Drug|methotrexate|
16386041|NCT00003536|Procedure|alternative product therapy|
16386042|NCT00003536|Procedure|biological therapy|
16386043|NCT00003536|Procedure|biologically based therapies|
16386044|NCT00003536|Procedure|cancer prevention intervention|
16386045|NCT00003536|Procedure|chemotherapy|
16386046|NCT00003536|Procedure|complementary and alternative therapy|
16386047|NCT00003536|Procedure|differentiation therapy|
16386048|NCT00003535|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386049|NCT00003534|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Refractory Stage IV Prostate Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386050|NCT00003533|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Metastatic Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386051|NCT00003532|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage III or IV Ovarian Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386052|NCT00003531|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386053|NCT00003530|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Primary Liver Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386054|NCT00003526|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386055|NCT00003525|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Cancer of the Cervix and/or Vulva will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386056|NCT00003524|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stomach Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386057|NCT00003522|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Cancer of the Small Intestine will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386058|NCT00003521|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Soft Tissue Sarcoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386059|NCT00003520|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Kidney Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386060|NCT00003517|Drug|antineoplaston A10|
16386061|NCT00003517|Drug|antineoplaston AS2-1|
16386062|NCT00003517|Drug|bicalutamide|
16386063|NCT00003517|Drug|flutamide|
16386064|NCT00003517|Drug|leuprolide acetate|
16386065|NCT00003517|Procedure|alternative product therapy|
16386066|NCT00003517|Procedure|antiandrogen therapy|
16386067|NCT00003517|Procedure|biological therapy|
16386068|NCT00003517|Procedure|biologically based therapies|
16386069|NCT00003517|Procedure|cancer prevention intervention|
16386070|NCT00003517|Procedure|complementary and alternative therapy|
16386071|NCT00003517|Procedure|differentiation therapy|
16386072|NCT00003517|Procedure|endocrine therapy|
16386073|NCT00003517|Procedure|hormone therapy|
16386327|NCT00003199|Biological|aldesleukin|Given SC
16386328|NCT00003199|Biological|sargramostim|Given SC
16386074|NCT00003516|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
16386075|NCT00003515|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386076|NCT00003514|Drug|antineoplaston A10|
16386077|NCT00003514|Drug|antineoplaston AS2-1|
16386078|NCT00003514|Procedure|alternative product therapy|
16386079|NCT00003514|Procedure|biological therapy|
16386080|NCT00003514|Procedure|biologically based therapies|
16386081|NCT00003514|Procedure|cancer prevention intervention|
16386082|NCT00003514|Procedure|complementary and alternative therapy|
16386083|NCT00003514|Procedure|differentiation therapy|
16386084|NCT00003513|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Metastatic, Recurrent, or Refractory Neuroblastoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386085|NCT00003512|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386086|NCT00003511|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386087|NCT00003509|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386088|NCT00003508|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386089|NCT00003505|Drug|antineoplaston A10|
16386090|NCT00003505|Drug|antineoplaston AS2-1|
16386091|NCT00003505|Procedure|alternative product therapy|
16386092|NCT00003505|Procedure|biological therapy|
16386093|NCT00003505|Procedure|biologically based therapies|
16386094|NCT00003505|Procedure|cancer prevention intervention|
16386095|NCT00003505|Procedure|complementary and alternative therapy|
16386096|NCT00003505|Procedure|differentiation therapy|
16386097|NCT00003502|Drug|antineoplaston A10|
16386098|NCT00003502|Drug|antineoplaston AS2-1|
16386099|NCT00003502|Procedure|alternative product therapy|
16386100|NCT00003502|Procedure|biological therapy|
16386101|NCT00003502|Procedure|biologically based therapies|
16386102|NCT00003502|Procedure|cancer prevention intervention|
16386103|NCT00003502|Procedure|complementary and alternative therapy|
16386104|NCT00003502|Procedure|differentiation therapy|
16386105|NCT00003501|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386106|NCT00003500|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386107|NCT00003499|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386108|NCT00003498|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386109|NCT00003497|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
16386110|NCT00003496|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Recurrent or Extensive-Stage Small Cell Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386111|NCT00003495|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV or Recurrent Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386112|NCT00003494|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Recurrent or Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386113|NCT00003492|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386114|NCT00003491|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386115|NCT00003489|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Advanced Head and Neck Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386116|NCT00003487|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386117|NCT00003486|Drug|antineoplaston A10|
16386118|NCT00003486|Drug|antineoplaston AS2-1|
16386119|NCT00003486|Procedure|alternative product therapy|
16386120|NCT00003486|Procedure|biological therapy|
16386121|NCT00003486|Procedure|biologically based therapies|
16386122|NCT00003486|Procedure|cancer prevention intervention|
16386123|NCT00003486|Procedure|complementary and alternative therapy|
16386124|NCT00003486|Procedure|differentiation therapy|
16386125|NCT00003485|Drug|antineoplaston A10, antineoplaston AS2-1 (ANP)|"Patients with metastatic or unresectable Colon Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386126|NCT00003483|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386127|NCT00003479|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386128|NCT00003478|Procedure|conventional surgery|
16386129|NCT00003478|Radiation|iodine I 131 monoclonal antibody 81C6|
16386130|NCT00003478|Radiation|radiation therapy|
16386131|NCT00003477|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).
16386132|NCT00003476|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
16386133|NCT00003475|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386134|NCT00003474|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386135|NCT00003473|Drug|Atengenal|Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386136|NCT00003473|Drug|Astugenal|Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386137|NCT00003472|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16386138|NCT00003471|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386139|NCT00003470|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386140|NCT00003469|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
16386141|NCT00003468|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
16386142|NCT00003467|Drug|carmustine|
16386143|NCT00003467|Drug|polifeprosan 20 with carmustine implant|
16386144|NCT00003467|Procedure|surgical procedure|
16386145|NCT00003466|Drug|temozolomide|
16386146|NCT00003462|Drug|busulfan|
16386147|NCT00003461|Procedure|surgical procedure|
16386148|NCT00003461|Radiation|astatine At 211 monoclonal antibody 81C6|
16386149|NCT00003460|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
16386150|NCT00003459|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)
16386151|NCT00003458|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
16386152|NCT00003457|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
16386329|NCT00003199|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell infusion
16386428|NCT00003053|Drug|etoposide|
16386153|NCT00003456|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386154|NCT00003455|Drug|antineoplaston A10|
16386155|NCT00003455|Drug|antineoplaston AS2-1|
16386156|NCT00003455|Procedure|alternative product therapy|
16386157|NCT00003455|Procedure|biological therapy|
16386158|NCT00003455|Procedure|biologically based therapies|
16386159|NCT00003455|Procedure|cancer prevention intervention|
16386160|NCT00003455|Procedure|complementary and alternative therapy|
16386161|NCT00003455|Procedure|differentiation therapy|
16386162|NCT00003454|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Breast Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386163|NCT00003453|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386164|NCT00003452|Drug|Antineoplaston therapy (Atengenal + Astugenal)|"Patients with Stage IV Bladder Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
16386165|NCT00003440|Drug|paclitaxel|Given IV over 1 hour or 3 hours
16386166|NCT00003440|Biological|trastuzumab|Given IV
16386167|NCT00003440|Procedure|quality-of-life assessment|Ancillary studies
16386168|NCT00003440|Other|laboratory biomarker analysis|Correlative studies
16386169|NCT00003437|Drug|asparaginase|
16386170|NCT00003437|Drug|cyclophosphamide|
16386171|NCT00003437|Drug|cytarabine|
16386172|NCT00003437|Drug|daunorubicin hydrochloride|
16386173|NCT00003437|Drug|dexamethasone|
16386174|NCT00003437|Drug|doxorubicin hydrochloride|
16386175|NCT00003437|Drug|mercaptopurine|
16386176|NCT00003437|Drug|methotrexate|
16386177|NCT00003437|Drug|pegaspargase|
16386178|NCT00003437|Drug|prednisolone|
16386179|NCT00003437|Drug|thioguanine|
16386180|NCT00003437|Drug|vincristine sulfate|
16386181|NCT00003437|Radiation|radiation therapy|
16386182|NCT00003429|Procedure|biopsy|
16386183|NCT00003429|Procedure|computed tomography|
16386184|NCT00003429|Procedure|positron emission tomography|
16386185|NCT00003429|Radiation|fludeoxyglucose F 18|
16386186|NCT00003422|Drug|fluorouracil|
16386187|NCT00003422|Drug|leucovorin calcium|
16386188|NCT00003422|Procedure|adjuvant therapy|
16386189|NCT00003422|Procedure|conventional surgery|
16386190|NCT00003422|Procedure|neoadjuvant therapy|
16386191|NCT00003422|Radiation|radiation therapy|
16386192|NCT00003420|Procedure|computed tomography|
16386193|NCT00003419|Procedure|antiviral therapy|
16386194|NCT00003417|Drug|carmustine|
16386195|NCT00003417|Radiation|radiation therapy|
16386196|NCT00003404|Radiation|Adjuvant Radiotherapy|Adjuvant radiation therapy
16386197|NCT00003389|Drug|Doxorubicin|given IV
16386198|NCT00003389|Drug|Bleomycin|given IV
16386199|NCT00003389|Drug|Vinblastine|given IV
16386200|NCT00003389|Drug|Dacarbazine|given IV
16386201|NCT00003389|Drug|Vincristine|given IV
16386202|NCT00003389|Drug|Mechlorethamine|given IV
16386203|NCT00003389|Drug|Etoposide|given IV
16386204|NCT00003389|Drug|Prednisone|taken orally
16386205|NCT00003389|Drug|Cyclophosphamide|given IV
16386206|NCT00003389|Radiation|Radiotherapy|
16386207|NCT00003385|Drug|carboplatin|
16386208|NCT00003385|Drug|paclitaxel|
16386209|NCT00003385|Drug|pegylated liposomal doxorubicin hydrochloride|
16386210|NCT00003384|Other|Cervical Papanicolaou Test|Undergo Pap smear
16386211|NCT00003384|Procedure|Conization|Undergo cone biopsy
16386212|NCT00003384|Other|Laboratory Biomarker Analysis|Correlative studies
16386213|NCT00003379|Drug|cisplatin|
16386214|NCT00003379|Drug|paclitaxel|
16386215|NCT00003379|Radiation|brachytherapy|
16386216|NCT00003379|Radiation|radiation therapy|
16386217|NCT00003377|Drug|cisplatin|
16386218|NCT00003377|Drug|paclitaxel|
16386219|NCT00003377|Radiation|brachytherapy|
16386220|NCT00003377|Radiation|radiation therapy|
16386221|NCT00003375|Drug|lomustine|
16386222|NCT00003375|Drug|procarbazine hydrochloride|
16386223|NCT00003375|Drug|vincristine sulfate|
16386224|NCT00003375|Radiation|radiation therapy|
16386225|NCT00003354|Procedure|conventional surgery|
16386226|NCT00003354|Procedure|laparoscopic surgery|
16386227|NCT00003342|Biological|filgrastim|
16386228|NCT00003342|Drug|carboplatin|
16386229|NCT00003342|Drug|doxorubicin hydrochloride|
16386230|NCT00003342|Drug|gemcitabine hydrochloride|
16386231|NCT00003342|Drug|paclitaxel|
16386232|NCT00003336|Biological|anti-thymocyte globulin|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386233|NCT00003336|Drug|busulfan|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386234|NCT00003336|Drug|cyclophosphamide|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386235|NCT00003336|Drug|melphalan|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386236|NCT00003336|Drug|methylprednisolone|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386237|NCT00003336|Procedure|bone marrow ablation with stem cell support|
16386238|NCT00003336|Procedure|umbilical cord blood transplantation|One day after the conditioning regimen is completed, patients receive the UCBT.
16386239|NCT00003336|Radiation|radiation therapy|The regimen varies according to the underlying cause of the anemia.Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT).
16386240|NCT00003335|Biological|anti-thymocyte globulin|antithymocyte globulin IV for three days on days -3 to -1
16386241|NCT00003335|Drug|busulfan|If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
16386242|NCT00003335|Drug|cyclosporine|Cyclosporine begin on day -2 and continue for 6 months.
16386243|NCT00003335|Drug|melphalan|melphalan IV for three days on days -4 to -2
16386244|NCT00003335|Drug|methylprednisolone|Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
16386245|NCT00003335|Procedure|umbilical cord blood transplantation|On day 0, patients receive umbilical cord blood infusion.
16386246|NCT00003335|Radiation|radiation therapy|9 fractions of total body irradiation (TBI) on days -9 to -5
16386247|NCT00003332|Drug|cisplatin|
16386248|NCT00003332|Drug|gemcitabine hydrochloride|
16386249|NCT00003332|Procedure|surgical procedure|
16386250|NCT00003332|Radiation|radiation therapy|
16386251|NCT00003329|Genetic|gene mapping|
16386252|NCT00003325|Procedure|Sentinel lymph node mapping|Sentinel lymph node mapping
16386253|NCT00003309|Biological|filgrastim|
16386254|NCT00003309|Drug|cisplatin|
16386255|NCT00003309|Drug|cyclophosphamide|
16386256|NCT00003309|Drug|etoposide|
16386257|NCT00003309|Drug|vincristine sulfate|
16386258|NCT00003309|Procedure|adjuvant therapy|
16386259|NCT00003309|Radiation|radiation therapy|
16386260|NCT00003308|Radiation|stereotactic radiosurgery|
16386261|NCT00003292|Drug|ifosfamide|
16386262|NCT00003291|Genetic|cytogenetic analysis|
16386263|NCT00003291|Genetic|mutation analysis|
16386264|NCT00003291|Other|laboratory biomarker analysis|
16386265|NCT00003282|Drug|EF5|Given IV
16386266|NCT00003282|Procedure|therapeutic conventional surgery|Undergo resection
16386267|NCT00003282|Procedure|biopsy|Undergo biopsy
16386268|NCT00003282|Other|pharmacological study|Correlative studies
16386269|NCT00003278|Drug|dexamethasone|
16386270|NCT00003278|Radiation|radiation therapy|
16386271|NCT00003273|Biological|filgrastim|
16386272|NCT00003273|Drug|carboplatin|
16386273|NCT00003273|Drug|cisplatin|
16386274|NCT00003273|Drug|cyclophosphamide|
16386275|NCT00003273|Drug|etoposide|
16386276|NCT00003273|Drug|leucovorin calcium|
16386277|NCT00003273|Drug|methotrexate|
16386278|NCT00003273|Drug|temozolomide|
16386279|NCT00003273|Drug|thiotepa|
16386280|NCT00003273|Drug|vincristine sulfate|
16386281|NCT00003273|Procedure|autologous bone marrow transplantation|
16386282|NCT00003273|Procedure|peripheral blood stem cell transplantation|
16386283|NCT00003273|Radiation|radiation therapy|
16386284|NCT00003268|Drug|amifostine trihydrate|
16386285|NCT00003268|Drug|cytarabine|
16386286|NCT00003268|Drug|idarubicin|
16386287|NCT00003261|Drug|methotrexate|
16386288|NCT00003261|Drug|zidovudine|
16386289|NCT00003261|Procedure|neoadjuvant therapy|
16386290|NCT00003261|Radiation|radiation therapy|
16386291|NCT00003243|Biological|aldesleukin|
16386292|NCT00003243|Biological|filgrastim|
16386293|NCT00003243|Biological|therapeutic allogeneic lymphocytes|
16386294|NCT00003243|Drug|cyclophosphamide|
16386295|NCT00003243|Drug|etoposide|
16386296|NCT00003243|Drug|pegylated liposomal doxorubicin hydrochloride|
16386297|NCT00003216|Drug|fluorouracil|
16386298|NCT00003216|Drug|gemcitabine hydrochloride|
16386299|NCT00003216|Radiation|radiation therapy|
16386300|NCT00003215|Biological|filgrastim|
16386301|NCT00003215|Drug|CHOP regimen|
16386302|NCT00003215|Drug|cyclophosphamide|
16386303|NCT00003215|Drug|cytarabine|
16386304|NCT00003215|Drug|doxorubicin hydrochloride|
16386305|NCT00003215|Drug|etoposide|
16386306|NCT00003215|Drug|leucovorin calcium|
16386307|NCT00003215|Drug|melphalan|
16386308|NCT00003215|Drug|methotrexate|
16386309|NCT00003215|Drug|methylprednisolone|
16386310|NCT00003215|Drug|mitoxantrone hydrochloride|
16386311|NCT00003215|Drug|prednisone|
16386312|NCT00003215|Drug|therapeutic hydrocortisone|
16386313|NCT00003215|Drug|vincristine sulfate|
16386314|NCT00003215|Procedure|bone marrow ablation with stem cell support|
16386315|NCT00003215|Procedure|peripheral blood stem cell transplantation|
16386316|NCT00003215|Radiation|radiation therapy|
16386317|NCT00003204|Drug|cyclophosphamide|Given IV
16386318|NCT00003204|Drug|fludarabine phosphate|Given IV
16386319|NCT00003204|Drug|vincristine sulfate|Given IV
16386320|NCT00003204|Drug|prednisone|Given PO
16386321|NCT00003204|Biological|rituximab|Given IV
16386322|NCT00003204|Other|laboratory biomarker analysis|Correlative studies
16386323|NCT00003199|Drug|tamoxifen citrate|Given orally
16386324|NCT00003199|Drug|busulfan|Given orally
16386325|NCT00003199|Drug|thiotepa|Given IV
16386326|NCT00003199|Drug|melphalan|Given IV
16386330|NCT00003199|Radiation|radiation therapy|May undergo radiotherapy after completion of IL-2/GM-CSF
16386331|NCT00003194|Biological|filgrastim|
16386332|NCT00003194|Drug|carboplatin|
16386333|NCT00003194|Drug|cyclophosphamide|
16386334|NCT00003194|Drug|etoposide|
16386335|NCT00003194|Drug|thiotepa|
16386336|NCT00003194|Drug|topotecan hydrochloride|
16386337|NCT00003194|Procedure|peripheral blood stem cell transplantation|
16386338|NCT00003179|Drug|medroxyprogesterone|
16386339|NCT00003178|Biological|filgrastim|
16386340|NCT00003178|Drug|cladribine|
16386341|NCT00003178|Drug|idarubicin|
16386342|NCT00003174|Drug|bryostatin 1|
16386343|NCT00003174|Drug|cladribine|
16386344|NCT00003159|Drug|carboplatin|
16386345|NCT00003159|Drug|cisplatin|
16386346|NCT00003159|Drug|docetaxel|
16386347|NCT00003159|Drug|gemcitabine hydrochloride|
16386348|NCT00003159|Drug|ifosfamide|
16386349|NCT00003159|Drug|mitomycin C|
16386350|NCT00003159|Drug|paclitaxel|
16386351|NCT00003159|Drug|vinblastine sulfate|
16386352|NCT00003159|Drug|vinorelbine tartrate|
16386353|NCT00003159|Procedure|conventional surgery|
16386354|NCT00003159|Procedure|neoadjuvant therapy|
16386355|NCT00003153|Biological|therapeutic allogeneic lymphocytes|
16386356|NCT00003145|Drug|Fludarabine Phosphate|Given IV
16386357|NCT00003145|Radiation|Total-Body Irradiation|Undergo TBI
16386358|NCT00003145|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT
16386359|NCT00003145|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16386360|NCT00003145|Drug|Cyclosporine|Given PO or IV
16386361|NCT00003145|Drug|Mycophenolate Mofetil|Given PO or IV
16386362|NCT00003145|Biological|Therapeutic Allogeneic Lymphocytes|Given IV
16386363|NCT00003145|Other|Laboratory Biomarker Analysis|Correlative studies
16386364|NCT00003140|Drug|letrozole|Given orally
16386365|NCT00003140|Other|placebo|Given orally
16386366|NCT00003138|Biological|Erythropoietin|Administered at 150 units/kg subcutaneously every day. Rotating sites should be used. The dose should be rounded off to the nearest 1000 U. The dose should be adjusted based on hematocrit.
16386367|NCT00003138|Biological|Filgrastim|G-CSF should start at a dose of 1 mcg/kg per day or 2.5 mcg/kg three times a week subcutaneously. Rotating sites should be used The dose should be rounded off to the nearest 10 mcg.
16386368|NCT00003138|Procedure|Transfusion|Red cell and platelet transfusions
16386369|NCT00003135|Drug|fluorouracil|
16386370|NCT00003135|Drug|pegylated liposomal doxorubicin hydrochloride|
16386371|NCT00003135|Procedure|hyperthermia treatment|
16386372|NCT00003128|Biological|filgrastim|
16386373|NCT00003128|Drug|ifosfamide|
16386374|NCT00003128|Drug|paclitaxel|
16386375|NCT00003122|Procedure|surgical procedure|
16386376|NCT00003119|Biological|filgrastim|
16386377|NCT00003119|Biological|sargramostim|
16386378|NCT00003119|Drug|carboplatin|
16386379|NCT00003119|Drug|cyclophosphamide|
16386380|NCT00003119|Drug|doxorubicin hydrochloride|
16386381|NCT00003119|Drug|etoposide|
16386382|NCT00003119|Procedure|adjuvant therapy|
16386383|NCT00003119|Procedure|conventional surgery|
16386384|NCT00003119|Radiation|radiation therapy|
16386385|NCT00003116|Biological|filgrastim|Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.
16386386|NCT00003116|Drug|busulfan|high-dose oral busulfan every 6 hours on days -8 to -5
16386387|NCT00003116|Drug|cyclophosphamide|cyclophosphamide IV twice a day on days -4 and -3
16386388|NCT00003116|Drug|cyclosporine|cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only)
16386389|NCT00003116|Procedure|bone marrow ablation with stem cell support|
16386390|NCT00003116|Procedure|peripheral blood stem cell transplantation|Allogeneic peripheral blood progenitor cells IV are administered on day 0.
16386391|NCT00003111|Drug|carboplatin|
16386392|NCT00003111|Drug|cisplatin|
16386393|NCT00003111|Drug|irinotecan hydrochloride|
16386394|NCT00003111|Drug|paclitaxel|
16386395|NCT00003111|Procedure|neoadjuvant therapy|
16386396|NCT00003111|Procedure|surgical procedure|
16386397|NCT00003111|Radiation|radiation therapy|
16386398|NCT00003105|Biological|filgrastim|
16386399|NCT00003105|Drug|cisplatin|
16386400|NCT00003105|Drug|doxorubicin hydrochloride|
16386401|NCT00003105|Drug|gemcitabine hydrochloride|
16386402|NCT00003105|Drug|ifosfamide|
16386403|NCT00003105|Drug|paclitaxel|
16386404|NCT00003104|Radiation|radiation therapy|
16386405|NCT00003096|Genetic|DNA ploidy analysis|
16386406|NCT00003096|Genetic|comparative genomic hybridization|
16386407|NCT00003096|Genetic|cytogenetic analysis|
16386408|NCT00003096|Genetic|fluorescence in situ hybridization|
16386409|NCT00003093|Biological|filgrastim|
16386410|NCT00003093|Biological|sargramostim|
16386411|NCT00003093|Drug|carboplatin|
16386412|NCT00003093|Drug|cyclophosphamide|
16386413|NCT00003093|Drug|doxorubicin hydrochloride|
16386414|NCT00003093|Drug|etoposide|
16386415|NCT00003093|Procedure|conventional surgery|
16386416|NCT00003093|Procedure|neoadjuvant therapy|
16386417|NCT00003092|Drug|paclitaxel|
16386418|NCT00003067|Biological|aldesleukin|
16386419|NCT00003067|Biological|lymphokine-activated killer cells|
16386420|NCT00003065|Biological|filgrastim|
16386421|NCT00003065|Drug|paclitaxel|
16386422|NCT00003065|Drug|topotecan hydrochloride|
16386423|NCT00003063|Biological|recombinant interferon alfa|
16386424|NCT00003063|Drug|fluorouracil|
16386425|NCT00003063|Drug|leucovorin calcium|
16386426|NCT00003063|Drug|levamisole hydrochloride|
16386429|NCT00003053|Procedure|adjuvant therapy|
16386430|NCT00003052|Drug|doxorubicin hydrochloride|
16386431|NCT00003052|Drug|etoposide|
16386432|NCT00003052|Drug|ifosfamide|
16386433|NCT00003052|Procedure|conventional surgery|
16386434|NCT00003052|Procedure|hyperthermia treatment|
16386435|NCT00003052|Radiation|radiation therapy|
16386436|NCT00003049|Drug|fluorouracil|
16386437|NCT00003049|Drug|leucovorin calcium|
16386438|NCT00003049|Procedure|conventional surgery|
16386439|NCT00003049|Radiation|radiation therapy|
16386440|NCT00003042|Biological|filgrastim|
16386441|NCT00003042|Drug|cisplatin|
16386442|NCT00003042|Drug|cyclophosphamide|
16386443|NCT00003042|Drug|doxorubicin hydrochloride|
16386444|NCT00003042|Drug|melphalan|
16386445|NCT00003042|Drug|mesna|
16386446|NCT00003042|Drug|paclitaxel|
16386447|NCT00003042|Drug|tamoxifen citrate|
16386448|NCT00003042|Procedure|bone marrow ablation with stem cell support|
16386449|NCT00003042|Procedure|conventional surgery|
16386450|NCT00003042|Procedure|peripheral blood stem cell transplantation|
16386451|NCT00003034|Drug|doxorubicin hydrochloride|Given IV
16386452|NCT00003034|Drug|ranpirnase|Given IV
16386453|NCT00003029|Drug|cisplatin|
16386454|NCT00003029|Drug|fluorouracil|
16386455|NCT00003027|Biological|aldesleukin|
16386456|NCT00003027|Biological|filgrastim|
16386457|NCT00003027|Biological|recombinant interferon alfa|
16386458|NCT00003027|Drug|cisplatin|
16386459|NCT00003027|Drug|dacarbazine|
16386460|NCT00003027|Drug|vinblastine|
16386461|NCT00003026|Drug|bicalutamide|
16386462|NCT00003026|Drug|flutamide|
16386463|NCT00003026|Drug|triptorelin|
16386464|NCT00003026|Radiation|radiation therapy|
16386465|NCT00003023|Biological|BCG vaccine|
16386466|NCT00003023|Biological|monoclonal antibody A1G4 anti-idiotype vaccine|
16386467|NCT00003022|Radiation|iodine I 131 monoclonal antibody 3F8|
16386468|NCT00003016|Drug|tamoxifen citrate|
16386469|NCT00003016|Procedure|adjuvant therapy|
16386470|NCT00003013|Drug|CMF regimen|
16386471|NCT00003013|Drug|cyclophosphamide|
16386472|NCT00003013|Drug|doxorubicin hydrochloride|
16386473|NCT00003013|Drug|fluorouracil|
16386474|NCT00003013|Drug|methotrexate|
16386475|NCT00003013|Drug|paclitaxel|
16386476|NCT00003013|Drug|tamoxifen citrate|
16386477|NCT00003013|Procedure|conventional surgery|
16386478|NCT00003013|Radiation|radiation therapy|
16386479|NCT00002996|Drug|flecainide acetate|
16386480|NCT00002995|Biological|dactinomycin|
16386481|NCT00002995|Biological|filgrastim|
16386482|NCT00002995|Biological|sargramostim|
16386483|NCT00002995|Drug|cyclophosphamide|
16386484|NCT00002995|Drug|vincristine sulfate|
16386485|NCT00002995|Radiation|radiation therapy|
16386486|NCT00002990|Biological|BCG vaccine|
16386487|NCT00002986|Drug|carmustine|
16386488|NCT00002986|Drug|topotecan hydrochloride|
16386489|NCT00002982|Biological|filgrastim|
16386490|NCT00002982|Drug|carboplatin|
16386491|NCT00002982|Drug|carmustine|
16386492|NCT00002982|Drug|cytarabine|
16386493|NCT00002982|Drug|etoposide|
16386494|NCT00002982|Drug|ifosfamide|
16386495|NCT00002982|Drug|melphalan|
16386496|NCT00002982|Procedure|autologous bone marrow transplantation|
16386497|NCT00002982|Procedure|peripheral blood stem cell transplantation|
16386498|NCT00002982|Radiation|radiation therapy|
16386499|NCT00002981|Procedure|positron emission tomography|
16386500|NCT00002981|Radiation|fludeoxyglucose F 18|
16386501|NCT00002981|Radiation|methionine C 11|
16386502|NCT00002976|Drug|conjugated estrogens|
16386503|NCT00002975|Drug|aminolevulinic acid|
16386504|NCT00002968|Biological|edrecolomab|Given IV
16386505|NCT00002968|Other|laboratory biomarker analysis|Correlative studies
16386506|NCT00002963|Drug|aminolevulinic acid hydrochloride|
16386507|NCT00002963|Procedure|conventional surgery|
16386508|NCT00002951|Drug|fluorouracil|
16386509|NCT00002951|Drug|hydroxyurea|
16386510|NCT00002951|Procedure|surgical procedure|
16386511|NCT00002951|Radiation|radiation therapy|
16386512|NCT00002948|Biological|filgrastim|
16386513|NCT00002948|Drug|topotecan hydrochloride|
16386514|NCT00002948|Procedure|bone marrow ablation with stem cell support|
16386515|NCT00002948|Procedure|peripheral blood stem cell transplantation|
16386516|NCT00002944|Drug|carboplatin|Given IV
16386517|NCT00002944|Drug|lomustine|Given IV
16386518|NCT00002944|Drug|procarbazine hydrochloride|Given PO
16386519|NCT00002944|Drug|thioguanine|Given PO
16386520|NCT00002944|Drug|vincristine sulfate|Given PO and IV
16386521|NCT00002943|Drug|carboplatin|
16386522|NCT00002943|Drug|cyclophosphamide|
16386523|NCT00002943|Drug|etoposide|
16386524|NCT00002943|Procedure|autologous bone marrow transplantation|
16386525|NCT00002941|Drug|carmustine|
16386526|NCT00002941|Drug|cyclophosphamide|
16386527|NCT00002941|Drug|etoposide|
16386528|NCT00002941|Drug|mesna|
16386529|NCT00002941|Procedure|peripheral blood stem cell transplantation|
16386530|NCT00002938|Procedure|conventional surgery|Salvage prostatectomy
16386531|NCT00002931|Biological|filgrastim|5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
16386532|NCT00002931|Drug|carboplatin|AUC=7, daily X 3
16386533|NCT00002931|Drug|etoposide|20 mg/kg by 2 hours infusion daily X 3
16386534|NCT00002931|Drug|ifosfamide|3 gm/m2 IV over 30 minutes X 3 days
16386535|NCT00002931|Drug|paclitaxel|425 mg/m2 as 24 hour continuous infusion
16386720|NCT00002756|Drug|cytarabine|
16386536|NCT00002931|Procedure|autologous bone marrow transplantation|Given in two divided infusions on day -2 and day 0
16386537|NCT00002931|Procedure|bone marrow ablation with stem cell support|Two cycles of high dose chemotherapy followed by stem cell reinfusion
16386538|NCT00002926|Drug|cytarabine|
16386539|NCT00002926|Drug|etoposide|
16386540|NCT00002926|Drug|idarubicin|
16386541|NCT00002926|Procedure|allogeneic bone marrow transplantation|
16386542|NCT00002926|Procedure|peripheral blood stem cell transplantation|
16386543|NCT00002920|Drug|medroxyprogesterone|
16386544|NCT00002920|Drug|tamoxifen citrate|
16386545|NCT00002920|Procedure|adjuvant therapy|
16386546|NCT00002916|Biological|human papillomavirus 16 E7 peptide|
16386547|NCT00002916|Biological|synthetic human papillomavirus 16 E6 peptide|
16386548|NCT00002916|Procedure|adjuvant therapy|
16386549|NCT00002916|Procedure|surgical procedure|
16386550|NCT00002916|Radiation|radiation therapy|
16386551|NCT00002913|Drug|paclitaxel|Given IV
16386552|NCT00002913|Drug|cisplatin|Given IV
16386553|NCT00002913|Drug|topotecan hydrochloride|Given IV
16386554|NCT00002913|Biological|filgrastim|Given SC
16386555|NCT00002900|Procedure|management of therapy complications|
16386556|NCT00002899|Procedure|adjuvant therapy|
16386557|NCT00002899|Radiation|radiation therapy|
16386558|NCT00002899|Radiation|stereotactic radiosurgery|
16386559|NCT00002898|Biological|dactinomycin|
16386560|NCT00002898|Drug|carboplatin|
16386561|NCT00002898|Drug|cyclophosphamide|
16386562|NCT00002898|Drug|epirubicin hydrochloride|
16386563|NCT00002898|Drug|etoposide|
16386564|NCT00002898|Drug|ifosfamide|
16386565|NCT00002898|Drug|vincristine sulfate|
16386566|NCT00002898|Procedure|adjuvant therapy|
16386567|NCT00002898|Procedure|conventional surgery|
16386568|NCT00002898|Procedure|neoadjuvant therapy|
16386569|NCT00002898|Radiation|brachytherapy|
16386570|NCT00002898|Radiation|radiation therapy|
16386571|NCT00002895|Drug|chemotherapy|
16386572|NCT00002894|Drug|carboplatin|
16386573|NCT00002894|Drug|cisplatin|
16386574|NCT00002894|Drug|paclitaxel|
16386575|NCT00002883|Drug|cisplatin|
16386576|NCT00002883|Drug|fluorouracil|
16386577|NCT00002883|Procedure|adjuvant therapy|
16386578|NCT00002883|Procedure|conventional surgery|
16386579|NCT00002883|Procedure|neoadjuvant therapy|
16386580|NCT00002882|Biological|Aldesleukin (IL-2)|Infusion for a total of 96 hours on days 1-4
16386581|NCT00002882|Biological|Recombinant Interferon Alfa (IFN-A)|"IFN-A Therapy Groups:
~Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
~Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks
~Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5"
16386582|NCT00002882|Drug|Cisplatin|IV Days 1-4
16386583|NCT00002882|Drug|Dacarbazine|IVPB on day 1
16386584|NCT00002882|Drug|Vinblastine|IVPB on days 1-4
16386585|NCT00002882|Procedure|Adjuvant Therapy|Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.
16386586|NCT00002874|Drug|bicalutamide|One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
16386587|NCT00002874|Radiation|radiation therapy|64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.
16386588|NCT00002874|Drug|placebo|One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
16386589|NCT00002860|Procedure|Surgery|Complete surgical resection of metastatic melanoma
16386590|NCT00002855|Drug|Bicalutamide|
16386591|NCT00002855|Drug|Doxorubicin hydrochloride|
16386592|NCT00002855|Drug|Estramustine Phosphate Sodium|
16386593|NCT00002855|Drug|Flutamide|
16386594|NCT00002855|Drug|Ketoconazole|
16386595|NCT00002855|Drug|Nilutamide|
16386596|NCT00002855|Drug|Therapeutic Hydrocortisone|
16386597|NCT00002855|Drug|Vinblastine|
16386598|NCT00002855|Procedure|Conventional Surgery|Surgical castration
16386599|NCT00002854|Biological|filgrastim|
16386600|NCT00002854|Drug|carboplatin|
16386601|NCT00002854|Drug|cisplatin|
16386602|NCT00002854|Drug|cyclophosphamide|
16386603|NCT00002854|Drug|etoposide|
16386604|NCT00002854|Drug|ifosfamide|
16386605|NCT00002854|Drug|mesna|
16386606|NCT00002854|Drug|paclitaxel|
16386607|NCT00002854|Procedure|peripheral blood stem cell transplantation|
16386608|NCT00002852|Drug|paclitaxel|Given IV
16386609|NCT00002852|Drug|carboplatin|Given IV
16386610|NCT00002852|Procedure|therapeutic conventional surgery|Undergo surgery
16386611|NCT00002851|Procedure|adjuvant therapy|
16386612|NCT00002851|Radiation|low-LET electron therapy|
16386613|NCT00002851|Radiation|low-LET photon therapy|
16386614|NCT00002850|Drug|ciprofloxacin|Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
16386615|NCT00002850|Drug|ofloxacin|Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
16386616|NCT00002850|Drug|160 mg trimethoprim and 800 mg sulfamethoxazole|Begin oral TMP-SMX when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
16386617|NCT00002849|Biological|recombinant interferon alfa|first 2 years
16386721|NCT00002756|Drug|daunorubicin hydrochloride|
16386618|NCT00002849|Drug|dexamethasone|40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
16386619|NCT00002848|Procedure|psychosocial assessment and care|
16386620|NCT00002848|Procedure|quality-of-life assessment|
16386621|NCT00002847|Biological|aldesleukin|
16386622|NCT00002847|Biological|recombinant interferon alfa|
16386623|NCT00002847|Procedure|conventional surgery|
16386624|NCT00002846|Biological|aldesleukin|
16386625|NCT00002846|Procedure|conventional surgery|
16386626|NCT00002842|Drug|floxuridine|Starting dose of 0.2 mg/kg/day for 14 consecutive days.
16386627|NCT00002842|Drug|fluorouracil|300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
16386628|NCT00002842|Drug|leucovorin calcium|500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
16386629|NCT00002842|Procedure|adjuvant therapy|Chemotherapy given after hepatic resection
16386630|NCT00002842|Procedure|conventional surgery|Hepatic resection
16386631|NCT00002839|Drug|cisplatin|
16386632|NCT00002839|Drug|fluorouracil|
16386633|NCT00002839|Procedure|conventional surgery|
16386634|NCT00002839|Procedure|neoadjuvant therapy|
16386635|NCT00002839|Radiation|radiation therapy|
16386636|NCT00002810|Biological|filgrastim|
16386637|NCT00002810|Drug|melphalan|
16386638|NCT00002810|Procedure|bone marrow ablation with stem cell support|
16386639|NCT00002810|Procedure|peripheral blood stem cell transplantation|
16386640|NCT00002809|Biological|anti-thymocyte globulin|
16386641|NCT00002809|Biological|filgrastim|
16386642|NCT00002809|Biological|sargramostim|
16386643|NCT00002809|Biological|therapeutic immune globulin|
16386644|NCT00002809|Drug|cyclophosphamide|
16386645|NCT00002809|Drug|methotrexate|
16386646|NCT00002809|Drug|tacrolimus|
16386647|NCT00002809|Procedure|allogeneic bone marrow transplantation|
16386648|NCT00002809|Radiation|radiation therapy|
16386649|NCT00002807|Radiation|radiation therapy|45 Gy in 25 fractions over 5 weeks
16386650|NCT00002798|Drug|asparaginase|
16386651|NCT00002798|Drug|daunorubicin hydrochloride|
16386652|NCT00002798|Drug|fludarabine phosphate|
16386653|NCT00002798|Drug|therapeutic hydrocortisone|
16386654|NCT00002798|Procedure|allogeneic bone marrow transplantation|
16386655|NCT00002798|Radiation|3-dimensional conformal radiation therapy|
16386656|NCT00002798|Biological|filgrastim|Given SC
16386657|NCT00002798|Drug|cytarabine|Given IV or IT
16386658|NCT00002798|Drug|idarubicin|Given IV
16386659|NCT00002798|Drug|dexamethasone|Given PO
16386660|NCT00002798|Drug|thioguanine|Given PO
16386661|NCT00002798|Drug|etoposide|Given IV
16386662|NCT00002798|Drug|methotrexate|Given IT
16386663|NCT00002798|Drug|cyclophosphamide|Given IV
16386664|NCT00002798|Biological|aldesleukin|
16386665|NCT00002798|Drug|busulfan|
16386666|NCT00002796|Drug|fluorouracil|Given IV
16386667|NCT00002796|Drug|sodium phenylbutyrate|Given IV
16386668|NCT00002796|Drug|indomethacin|Given orally
16386669|NCT00002796|Biological|recombinant interferon gamma|Given subcutaneously
16386670|NCT00002792|Drug|busulfan|
16386671|NCT00002792|Drug|cyclophosphamide|
16386672|NCT00002792|Drug|cyclosporine|
16386673|NCT00002792|Drug|methotrexate|
16386674|NCT00002792|Drug|tacrolimus|
16386675|NCT00002792|Procedure|allogeneic bone marrow transplantation|
16386676|NCT00002792|Procedure|peripheral blood stem cell transplantation|
16386677|NCT00002778|Biological|sargramostim|
16386678|NCT00002778|Biological|therapeutic allogeneic lymphocytes|
16386679|NCT00002778|Procedure|allogeneic bone marrow transplantation|
16386680|NCT00002778|Procedure|in vitro-treated bone marrow transplantation|
16386681|NCT00002771|Biological|recombinant interferon alfa|
16386682|NCT00002771|Drug|busulfan|
16386683|NCT00002771|Drug|cytarabine|
16386684|NCT00002771|Drug|hydroxyurea|
16386685|NCT00002771|Drug|idarubicin|
16386686|NCT00002771|Procedure|allogeneic bone marrow transplantation|
16386687|NCT00002771|Procedure|autologous bone marrow transplantation|
16386688|NCT00002771|Procedure|peripheral blood stem cell transplantation|
16386689|NCT00002771|Radiation|radiation therapy|
16386690|NCT00002766|Biological|dactinomycin|
16386691|NCT00002766|Biological|sargramostim|
16386692|NCT00002766|Drug|carmustine|
16386693|NCT00002766|Drug|cyclophosphamide|
16386694|NCT00002766|Drug|cytarabine|
16386695|NCT00002766|Drug|daunorubicin hydrochloride|
16386696|NCT00002766|Drug|doxorubicin hydrochloride|
16386697|NCT00002766|Drug|etoposide|
16386698|NCT00002766|Drug|mercaptopurine|
16386699|NCT00002766|Drug|methotrexate|
16386700|NCT00002766|Drug|mitoxantrone hydrochloride|
16386701|NCT00002766|Drug|pegaspargase|
16386702|NCT00002766|Drug|prednisone|
16386703|NCT00002766|Drug|vincristine sulfate|
16386704|NCT00002766|Radiation|radiation therapy|
16386705|NCT00002762|Behavioral|patient interviewing to obtain menstrual history|
16386706|NCT00002762|Procedure|blood sampling|
16386707|NCT00002757|Biological|filgrastim|
16386708|NCT00002757|Drug|cyclophosphamide|
16386709|NCT00002757|Drug|cytarabine|
16386710|NCT00002757|Drug|doxorubicin hydrochloride|
16386711|NCT00002757|Drug|etoposide|
16386712|NCT00002757|Drug|methotrexate|
16386713|NCT00002757|Drug|prednisolone|
16386714|NCT00002757|Drug|prednisone|
16386715|NCT00002757|Drug|therapeutic hydrocortisone|
16386716|NCT00002757|Drug|vincristine sulfate|
16386717|NCT00002756|Biological|filgrastim|
16386718|NCT00002756|Drug|asparaginase|
16386719|NCT00002756|Drug|cyclophosphamide|
16386722|NCT00002756|Drug|etoposide|
16386723|NCT00002756|Drug|leucovorin calcium|
16386724|NCT00002756|Drug|mercaptopurine|
16386725|NCT00002756|Drug|methotrexate|
16386726|NCT00002756|Drug|prednisone|
16386727|NCT00002756|Drug|therapeutic hydrocortisone|
16386728|NCT00002756|Drug|vincristine sulfate|
16386729|NCT00002746|Biological|aldesleukin|
16386730|NCT00002738|Drug|leucovorin calcium|
16386731|NCT00002738|Drug|trimetrexate glucuronate|
16386732|NCT00002727|Radiation|radiation therapy|
16386733|NCT00002720|Drug|tamoxifen citrate|
16386734|NCT00002720|Procedure|conventional surgery|
16386735|NCT00002718|Biological|anti-thymocyte globulin|
16386736|NCT00002718|Biological|filgrastim|
16386737|NCT00002718|Drug|cyclophosphamide|
16386738|NCT00002718|Drug|cytarabine|
16386739|NCT00002718|Drug|methylprednisolone|
16386740|NCT00002718|Drug|thiotepa|
16386741|NCT00002718|Procedure|in vitro-treated bone marrow transplantation|
16386742|NCT00002718|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16386743|NCT00002718|Radiation|radiation therapy|
16386744|NCT00002716|Drug|dexamethasone|
16386745|NCT00002716|Drug|floxuridine|
16386746|NCT00002716|Drug|fluorouracil|
16386747|NCT00002716|Drug|leucovorin calcium|
16386748|NCT00002716|Procedure|laparotomy|
16386749|NCT00002716|Procedure|conventional surgery|
16386750|NCT00002715|Biological|Bleomycin sulfate|A component of the Stanford V regimen.
16386751|NCT00002715|Drug|Stanford V regimen|
16386752|NCT00002715|Drug|Doxorubicin hydrochloride|A component of the Stanford V regimen.
16386753|NCT00002715|Drug|Etoposide|A component of the Stanford V regimen.
16386754|NCT00002715|Drug|Mechlorethamine hydrochloride|A component of the Stanford V regimen.
16386755|NCT00002715|Drug|Prednisone|A component of the Stanford V regimen.
16386756|NCT00002715|Drug|Vinblastine|A component of the Stanford V regimen.
16386757|NCT00002715|Drug|Vincristine sulfate|A component of the Stanford V regimen.
16386758|NCT00002706|Procedure|Laparoscopic Surgery|Undergo vaginal hysterectomy and BSO via laparoscopy
16386759|NCT00002706|Other|Quality-of-Life Assessment|Ancillary studies
16386760|NCT00002706|Procedure|Therapeutic Conventional Surgery|Undergo total abdominal hysterectomy and BSO via conventional laparotomy
16386761|NCT00002702|Biological|aldesleukin|
16386762|NCT00002702|Procedure|adjuvant therapy|
16386763|NCT00002702|Procedure|conventional surgery|
16386764|NCT00002702|Procedure|neoadjuvant therapy|
16386765|NCT00002702|Radiation|radiation therapy|
16386766|NCT00002700|Drug|asparaginase|
16386767|NCT00002700|Drug|cyclophosphamide|
16386768|NCT00002700|Drug|cytarabine|
16386769|NCT00002700|Drug|daunorubicin hydrochloride|
16386770|NCT00002700|Drug|dexamethasone|
16386771|NCT00002700|Drug|doxorubicin hydrochloride|
16386772|NCT00002700|Drug|leucovorin calcium|
16386773|NCT00002700|Drug|mercaptopurine|
16386774|NCT00002700|Drug|methotrexate|
16386775|NCT00002700|Drug|mitoxantrone hydrochloride|
16386776|NCT00002700|Drug|prednisolone|
16386777|NCT00002700|Drug|prednisone|
16386778|NCT00002700|Drug|therapeutic hydrocortisone|
16386779|NCT00002700|Drug|vincristine sulfate|
16386780|NCT00002700|Procedure|allogeneic bone marrow transplantation|
16386781|NCT00002700|Procedure|autologous bone marrow transplantation|
16386782|NCT00002700|Radiation|radiation therapy|
16386783|NCT00002697|Biological|filgrastim|
16386784|NCT00002697|Biological|sargramostim|
16386785|NCT00002697|Drug|carboplatin|
16386786|NCT00002697|Drug|etoposide|
16386787|NCT00002697|Drug|ifosfamide|
16386788|NCT00002697|Procedure|autologous bone marrow transplantation|
16386789|NCT00002697|Procedure|bone marrow ablation with stem cell support|
16386790|NCT00002697|Procedure|peripheral blood stem cell transplantation|
16386791|NCT00002697|Radiation|radiation therapy|
16386792|NCT00002696|Drug|CAF regimen|
16386793|NCT00002696|Drug|CMF regimen|
16386794|NCT00002696|Drug|cyclophosphamide|
16386795|NCT00002696|Drug|doxorubicin hydrochloride|
16386796|NCT00002696|Drug|fluorouracil|
16386797|NCT00002696|Drug|methotrexate|
16386798|NCT00002696|Procedure|adjuvant therapy|
16386799|NCT00002696|Procedure|conventional surgery|
16386800|NCT00002696|Procedure|neoadjuvant therapy|
16386801|NCT00002696|Radiation|radiation therapy|
16386802|NCT00002689|Drug|dexamethasone|
16386803|NCT00002689|Drug|fluorouracil|
16386804|NCT00002689|Radiation|brachytherapy|
16386805|NCT00002689|Radiation|phosphorus P32|
16386806|NCT00002689|Radiation|radiation therapy|
16386807|NCT00002687|Biological|aldesleukin|
16386808|NCT00002684|Drug|cisplatin|
16386809|NCT00002684|Drug|ifosfamide|
16386810|NCT00002684|Drug|paclitaxel|
16386811|NCT00002681|Biological|aldesleukin|
16386812|NCT00002681|Biological|daclizumab|
16386813|NCT00002678|Drug|dexamethasone|40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
16386814|NCT00002678|Drug|melphalan|9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
16386815|NCT00002678|Drug|prednisone|100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
16386816|NCT00002668|Behavioral|Observation|
16386817|NCT00002668|Behavioral|Educational Intervention and Behavioral Skills Training|
16386818|NCT00002663|Biological|allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)|EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
16386819|NCT00002662|Drug|docetaxel|
16386820|NCT00002662|Drug|paclitaxel|
16386821|NCT00002651|Drug|bicalutamide|Given orally
16386822|NCT00002651|Drug|goserelin acetate|Given subcutaneously
16386823|NCT00002651|Other|clinical observation|Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.
16386824|NCT00002649|Biological|aldesleukin|Given IV
16386825|NCT00002649|Biological|filgrastim|Given SC or IV
16386826|NCT00002649|Drug|cyclophosphamide|Given IV
16386827|NCT00002649|Drug|etoposide|Given IV
16386828|NCT00002649|Radiation|radiation therapy|Undergo radiation therapy
16386829|NCT00002649|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16386830|NCT00002649|Procedure|bone marrow ablation with stem cell support|Undergo bone marrow ablation with stem cell support
16386831|NCT00002647|Drug|verteporfin|
16386832|NCT00002647|Procedure|conventional surgery|
16386833|NCT00002641|Biological|filgrastim|
16386834|NCT00002641|Drug|doxorubicin hydrochloride|
16386835|NCT00002641|Drug|ifosfamide|
16386836|NCT00002641|Drug|isolated perfusion|
16386837|NCT00002641|Procedure|adjuvant therapy|
16386838|NCT00002641|Procedure|conventional surgery|
16386839|NCT00002641|Radiation|radiation therapy|
16386840|NCT00002633|Drug|bicalutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386841|NCT00002633|Drug|buserelin|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386842|NCT00002633|Drug|flutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386843|NCT00002633|Drug|goserelin|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386844|NCT00002633|Drug|leuprolide acetate|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386845|NCT00002633|Drug|nilutamide|Antiandrogen (optional with orchiectomy) Flutamide 250 mg po TID or Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD or Bicalutamide 50 mg po QD PLUS (patient's choice) Bilateral orchiectomy or LHRH agonist Goserelin 3.6 mg SC (abd) q28d or 10.8 mg SC (abd) Q3mos or Leuprolide 7.5 mg IM q28d (Leuprorelin 3.75 mg) or 22.5 mg IM Q3mos (Leuprorelin 11.25 mg) or 30 mg IM Q4mos or Buserelin 6.3mg SC (abd) Q8wk or 9.45mg SC (abd) Q12wk
16386846|NCT00002633|Procedure|orchiectomy|Optional orchiectomy
16386847|NCT00002633|Radiation|radiation therapy|Radical Radiation Therapy - (65-69 Gy; 35-37 treatments)
16386848|NCT00002624|Procedure|adjuvant therapy|
16386849|NCT00002624|Procedure|diagnostic thoracoscopy|
16386850|NCT00002624|Procedure|therapeutic thoracoscopy|
16386851|NCT00002624|Procedure|video-assisted surgery|
16386852|NCT00002624|Radiation|radiation therapy|
16386853|NCT00002623|Drug|carboplatin|
16386854|NCT00002623|Drug|cisplatin|
16386855|NCT00002623|Procedure|conventional surgery|
16386856|NCT00002623|Radiation|radiation therapy|
16386857|NCT00002615|Drug|cisplatin|
16386858|NCT00002615|Drug|epirubicin hydrochloride|
16386859|NCT00002615|Drug|fluorouracil|
16386860|NCT00002615|Procedure|conventional surgery|
16386861|NCT00002611|Biological|dactinomycin|
16386862|NCT00002611|Biological|filgrastim|
16386863|NCT00002611|Drug|cyclophosphamide|
16386864|NCT00002611|Drug|doxorubicin hydrochloride|Source and Pharmacology: An anthracycline antibiotic isolated from cultures of Streptomyces peucetius. Binds to DNA and inhibits nucleic acid synthesis, with its major lethal effect occurring during the S phase of the cell cycle. Has some topoisomerase II inhibitory activity. Since it is primarily excreted by the liver, any liver impairment may enhance toxicity. 40% to 50% is excreted in the bile; <5% in the urine. The drug has a very short initial t½ of <20 minutes and a terminal t½ of 17 hours. Animal studies indicate cytotoxic levels persist in tissue for as long as 24 hours.
16386865|NCT00002611|Drug|etoposide|
16386866|NCT00002611|Drug|vincristine sulfate|
16386867|NCT00002611|Procedure|conventional surgery|
16386868|NCT00002611|Radiation|radiation therapy|
16386869|NCT00002610|Biological|dactinomycin|
16386870|NCT00002610|Biological|filgrastim|
16386871|NCT00002610|Drug|carboplatin|
16386872|NCT00002610|Drug|cyclophosphamide|
16386873|NCT00002610|Drug|doxorubicin hydrochloride|
16386874|NCT00002610|Drug|etoposide|
16386875|NCT00002610|Drug|vincristine sulfate|IV
16386876|NCT00002610|Procedure|conventional surgery|
16386877|NCT00002610|Radiation|radiation therapy|
16386878|NCT00002608|Drug|cisplatin|
16386879|NCT00002608|Drug|doxorubicin hydrochloride|
16386880|NCT00002608|Drug|tamoxifen citrate|
16386881|NCT00002608|Procedure|conventional surgery|
16386882|NCT00002608|Radiation|radiation therapy|
16386883|NCT00002598|Biological|recombinant interferon alfa|
16386884|NCT00002598|Biological|sargramostim|
16386885|NCT00002598|Drug|cyclophosphamide|
16386886|NCT00002598|Drug|cytarabine|
16386887|NCT00002598|Drug|etoposide|
16386888|NCT00002598|Drug|methotrexate|
16386889|NCT00002598|Drug|mitoxantrone hydrochloride|
16386890|NCT00002598|Procedure|bone marrow ablation with stem cell support|
16386891|NCT00002598|Radiation|radiation therapy|
16386892|NCT00002596|Biological|bleomycin sulfate|
16386893|NCT00002596|Biological|filgrastim|
16386894|NCT00002596|Drug|carboplatin|
16386895|NCT00002596|Drug|cisplatin|
16386896|NCT00002596|Drug|cyclophosphamide|
16386897|NCT00002596|Drug|etoposide|
16386898|NCT00002596|Procedure|autologous bone marrow transplantation|
16386899|NCT00002596|Procedure|bone marrow ablation with stem cell support|
16386900|NCT00002596|Procedure|conventional surgery|
16386901|NCT00002596|Procedure|peripheral blood stem cell transplantation|
16386902|NCT00002596|Radiation|radiation therapy|
16386903|NCT00002594|Biological|Sargramostim|Given IV
16386904|NCT00002594|Drug|cyclophosphamide|Given IV
16386905|NCT00002594|Drug|melphalan|Given IV
16386906|NCT00002594|Procedure|autologous bone marrow transplantation|
16386907|NCT00002594|Procedure|bone marrow ablation with stem cell support|
16386908|NCT00002594|Procedure|peripheral blood stem cell transplantation|
16386909|NCT00002589|Biological|aldesleukin|
16386910|NCT00002589|Biological|muromonab-CD3|
16386911|NCT00002589|Biological|therapeutic autologous lymphocytes|
16386912|NCT00002589|Procedure|adjuvant therapy|
16386913|NCT00002586|Drug|13-cis retinoic acid|
16386914|NCT00002586|Dietary Supplement|Tocopherol|
16386915|NCT00002569|Drug|lomustine|
16386916|NCT00002569|Drug|procarbazine hydrochloride|
16386917|NCT00002569|Drug|vincristine sulfate|
16386918|NCT00002569|Radiation|radiation therapy|
16386919|NCT00002560|Biological|monoclonal antibody 3F8|
16386920|NCT00002560|Biological|sargramostim|
16386921|NCT00002558|Biological|filgrastim|
16386922|NCT00002558|Drug|carboplatin|
16386923|NCT00002558|Drug|etoposide|
16386924|NCT00002558|Drug|ifosfamide|
16386925|NCT00002558|Drug|paclitaxel|
16386926|NCT00002558|Procedure|peripheral blood stem cell transplantation|
16386927|NCT00002556|Drug|vincristine sulfate|Given IV
16386928|NCT00002556|Drug|carmustine|Given IV
16386929|NCT00002556|Drug|melphalan|Given PO
16386930|NCT00002556|Drug|cyclophosphamide|Given IV
16386931|NCT00002556|Drug|prednisone|Given PO
16386932|NCT00002556|Biological|recombinant interferon alfa-2b|Given SC
16386933|NCT00002556|Other|laboratory biomarker analysis|Correlative studies
16386934|NCT00002546|Drug|cisplatin|
16386935|NCT00002546|Drug|ifosfamide|
16386936|NCT00002546|Procedure|adjuvant therapy|
16386937|NCT00002546|Radiation|radiation therapy|
16386938|NCT00002544|Drug|docetaxel|
16386939|NCT00002544|Drug|mitoxantrone hydrochloride|
16386940|NCT00002528|Drug|tamoxifen citrate|20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
16386941|NCT00002528|Procedure|conventional surgery|Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
16386942|NCT00002528|Radiation|radiation therapy|No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.
16386943|NCT00002528|Procedure|Axillary clearance|Axillary node dissection.
16386944|NCT00002523|Drug|fluorouracil|
16386945|NCT00002523|Drug|leucovorin calcium|
16386946|NCT00002523|Procedure|conventional surgery|
16386947|NCT00002523|Radiation|radiation therapy|
16386948|NCT00002522|Drug|cisplatin|
16386949|NCT00002522|Drug|cyclophosphamide|
16386950|NCT00002522|Drug|etoposide|
16386951|NCT00002522|Procedure|autologous bone marrow transplantation|
16386952|NCT00002522|Procedure|bone marrow ablation with stem cell support|
16386953|NCT00002522|Procedure|peripheral blood stem cell transplantation|
16386954|NCT00002522|Procedure|syngeneic bone marrow transplantation|
16386955|NCT00002522|Radiation|radiation therapy|
16386956|NCT00002521|Drug|cisplatin|
16386957|NCT00002521|Drug|cyclophosphamide|
16386958|NCT00002521|Drug|etoposide|
16386959|NCT00002521|Procedure|autologous bone marrow transplantation|
16386960|NCT00002521|Procedure|bone marrow ablation with stem cell support|
16386961|NCT00002521|Procedure|peripheral blood stem cell transplantation|
16386962|NCT00002521|Procedure|syngeneic bone marrow transplantation|
16386963|NCT00002521|Radiation|radiation therapy|
16386964|NCT00002517|Drug|cytarabine|
16386965|NCT00002517|Drug|daunorubicin hydrochloride|
16386966|NCT00002517|Drug|dexamethasone|
16386967|NCT00002517|Drug|etoposide|
16386968|NCT00002517|Drug|idarubicin|
16386969|NCT00002517|Drug|mitoxantrone hydrochloride|
16386970|NCT00002517|Drug|thioguanine|
16386971|NCT00002517|Procedure|allogeneic bone marrow transplantation|
16386972|NCT00002517|Radiation|radiation therapy|
16386973|NCT00002515|Biological|filgrastim|
16386974|NCT00002515|Drug|carboplatin|
16386975|NCT00002515|Drug|thiotepa|
16386976|NCT00002515|Drug|topotecan hydrochloride|
16386977|NCT00002515|Procedure|autologous bone marrow transplantation|
16386978|NCT00002515|Procedure|bone marrow ablation with stem cell support|
16386979|NCT00002515|Procedure|in vitro-treated bone marrow transplantation|
16386980|NCT00002514|Biological|sargramostim|
16386981|NCT00002514|Drug|asparaginase|
16386982|NCT00002514|Drug|cyclophosphamide|
16386983|NCT00002514|Drug|cytarabine|
16386984|NCT00002514|Drug|daunorubicin hydrochloride|
16386985|NCT00002514|Drug|dexamethasone|
16386986|NCT00002514|Drug|etoposide|
16386987|NCT00002514|Drug|imatinib mesylate|
16386988|NCT00002514|Drug|leucovorin calcium|
16386989|NCT00002514|Drug|mercaptopurine|
16386990|NCT00002514|Drug|methotrexate|
16386991|NCT00002514|Drug|prednisone|
16386992|NCT00002514|Drug|thioguanine|
16386993|NCT00002514|Drug|vincristine sulfate|
16386994|NCT00002514|Procedure|allogeneic bone marrow transplantation|
16386995|NCT00002514|Procedure|autologous bone marrow transplantation|
16386996|NCT00002514|Procedure|peripheral blood stem cell transplantation|
16386997|NCT00002514|Radiation|radiation therapy|
16386998|NCT00002511|Radiation|low-LET photon therapy|
16386999|NCT00002490|Biological|BCG vaccine|
16387000|NCT00002490|Drug|mitomycin C|
16387001|NCT00002490|Radiation|radiation therapy|
16387002|NCT00002484|Radiation|radiation therapy|
16387003|NCT00002475|Biological|allogeneic tumor cell vaccine|
16387004|NCT00002475|Biological|autologous tumor cell vaccine|
16387005|NCT00002475|Biological|recombinant interferon alfa|
16387006|NCT00002475|Biological|recombinant interferon gamma|
16387007|NCT00002475|Biological|sargramostim|
16387008|NCT00002475|Drug|cyclophosphamide|
16387009|NCT00002474|Drug|carboplatin|
16387010|NCT00002474|Drug|cyclophosphamide|
16387011|NCT00002474|Drug|mitoxantrone hydrochloride|
16387012|NCT00002474|Procedure|autologous bone marrow transplantation|
16387013|NCT00002474|Procedure|bone marrow ablation with stem cell support|
16387014|NCT00002473|Procedure|conventional surgery|
16387015|NCT00002472|Drug|cisplatin|
16387016|NCT00002472|Drug|etoposide|
16387017|NCT00002472|Procedure|conventional surgery|
16387018|NCT00002472|Procedure|neoadjuvant therapy|
16387019|NCT00002472|Radiation|radiation therapy|
16387020|NCT00002470|Biological|recombinant interferon alfa|
16387021|NCT00002470|Drug|fluorouracil|
16387022|NCT00002455|Biological|Corynebacterium granulosum P40|
16387023|NCT00002455|Procedure|adjuvant therapy|
16387024|NCT00052156|Biological|CancerVax vaccine (CANVAXIN)|
16387025|NCT00052130|Biological|CancerVax vaccine (CANVAXIN)|
16387026|NCT00051818|Behavioral|Treatment interruption/reinitiation schedule|
16387027|NCT00052117|Drug|capravirine|
16387028|NCT00052117|Drug|Kaletra|
16387029|NCT00052117|Drug|2 NRTIs|
16387030|NCT00052104|Behavioral|Cognitive-Behavioral Family Systems Intervention|
16387031|NCT00052091|Behavioral|Problem Solving Therapy|A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
16387032|NCT00052091|Behavioral|Brief Supportive Therapy|A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.
16387033|NCT00052078|Drug|Sertraline (SRT)|Participants were treated with sertraline.
16387034|NCT00052078|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants received CBT.
16387035|NCT00052078|Drug|Placebo|Participants were treated with a placebo pill.
16387036|NCT00052065|Drug|TLK286|
16387037|NCT00052052|Drug|interferon-gamma 1b|200 mcg, SQ, 3x per week
16387038|NCT00052026|Drug|carvedilol|low-dose carvedilol administered twice daily for 8 months
16387039|NCT00052026|Drug|placebo|administered twice daily for 8 months
16387040|NCT00052026|Drug|carvedilol|high-dose carvedilol administered twice daily for 8 months
16387041|NCT00052039|Drug|interferon-gamma 1b|This study was terminated prior to enrollment.
16387042|NCT00052039|Drug|azathioprine|This study was terminated prior to enrollment.
16387043|NCT00052013|Drug|PTK787/ZK 222584|
16387044|NCT00052000|Drug|MLN2704 (DM1 conjugated monoclonal antibody MLN591)|
16387045|NCT00051987|Drug|VELCADE TM (bortezomib) for Injection, or PS-341|
16387046|NCT00051974|Drug|VELCADE™ (bortezomib) for Injection (formerly PS-341)|
16387047|NCT00051948|Drug|TLK286|
16387048|NCT00051935|Drug|Alglucosidase alfa|20 mg/kg (qow); intravenous
16387049|NCT00051922|Biological|PolyEnv1|Recombinant vaccinia virus vaccine
16387050|NCT00051909|Drug|LY451395|
16387051|NCT00051896|Drug|GBR 12909|
16387052|NCT00051844|Drug|Capravirine|
16387053|NCT00051831|Drug|Emtricitabine|Will be administered as one 200-mg capsule orally daily
16387054|NCT00051831|Drug|Enfuvirtide|Will be administered as a 90-mg (1.0 mL) subcutaneous injection twice daily
16387055|NCT00051831|Drug|Ritonavir|Will be administered as one 100-mg capsule orally twice daily
16387056|NCT00051831|Drug|Saquinavir|Will be administered as five hard gel capsules orally twice daily
16387057|NCT00051831|Drug|Tenofovir disoproxil fumarate|Will be administered as one 300-mg tablet orally daily
16387058|NCT00051870|Device|Magstim Rapid Magnetic Stimulator|
16387059|NCT00051805|Behavioral|Promotion of adherence to ARV medications|
16387060|NCT00051792|Behavioral|yoga|
16387061|NCT00051779|Drug|CAL|
16387062|NCT00051766|Behavioral|Computer-based Intervention|
16387063|NCT00051753|Drug|levofloxacin; amoxicillin/clavulanate|
16387064|NCT00051740|Behavioral|Cognitive Adaptation Therapy (CAT)|
16387065|NCT00051740|Behavioral|Minimal Environmental Supports (MES)|
16387066|NCT00051727|Behavioral|Bridges to High School Project|
16387067|NCT00051701|Drug|alemtuzumab|
16387068|NCT00051688|Drug|tezacitabine|
16387069|NCT00051688|Drug|oxaliplatin|
16387070|NCT00051675|Drug|ING-1(heMAb)|
16387071|NCT00051662|Drug|efalizumab|
16387072|NCT00051636|Drug|Zoledronic Acid|Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
16387073|NCT00051636|Drug|Risedronate|Oral risedronate 30 mg capsules.
16387308|NCT00001573|Drug|SU101|
16387074|NCT00051636|Drug|Placebo to Risedronate|Oral placebo of risedronate capsules.
16387075|NCT00051636|Drug|Placebo to Zoledronic Acid|5 mL of sterile water one dose intravenous infusion.
16387076|NCT00051636|Dietary Supplement|Calcium and Vitamin D|Calcium and vitamin D supplements were supplied.
16387077|NCT00051623|Drug|Infliximab|
16387078|NCT00051597|Drug|SGN-30 (monoclonal antibody)|
16387079|NCT00051584|Drug|SGN-15 (cBR96-Doxorubicin Immunoconjugate)|
16387080|NCT00051584|Drug|Gemzar (Gemcitabine)|
16387081|NCT00051571|Drug|SGN-15|
16387082|NCT00051571|Drug|Docetaxel|
16387083|NCT00051428|Procedure|Reiki (distant and direct-contact)|
16387084|NCT00051415|Behavioral|Flaxseed-supplemented diet|
16387085|NCT00051402|Drug|Isoflavones|
16387086|NCT00051558|Drug|Teriparatide|20 micrograms/day, injection, 36 months
16387087|NCT00051558|Drug|Alendronate Sodium|10 mg/day, oral, 36 months
16387088|NCT00051558|Drug|Placebo|Oral placebo, daily, 36 months
16387089|NCT00051558|Drug|Placebo|Injection placebo, daily, 36 months
16387090|NCT00051545|Drug|Seocalcitol|
16387091|NCT00051532|Drug|Seocalcitol|
16387092|NCT00051506|Drug|ALIMTA|
16387093|NCT00051506|Drug|carboplatin|
16387094|NCT00051506|Drug|cisplatin|
16387095|NCT00051493|Drug|ALIMTA|
16387096|NCT00051493|Drug|Carboplatin|
16387097|NCT00051480|Genetic|TNFerade|
16387098|NCT00051467|Genetic|TNFerade|
16387099|NCT00051454|Biological|HIV DNA plasmid vaccine plus recombinant fowlpox vector|
16387100|NCT00051441|Drug|Benzydamine Hydrochloride 0.15% Oral Rinse|
16387101|NCT00051389|Drug|Fosinopril|
16387102|NCT00051376|Drug|L-Arginine|
16387103|NCT00051363|Device|Active CPAP|Nightly nasal continuous positive airway pressure (CPAP)
16387104|NCT00051363|Device|Sham CPAP|Sham CPAP machine will be used for participants in the placebo group.
16387105|NCT00051350|Other|CARB|
16387106|NCT00051298|Drug|Olanzapine|
16387107|NCT00051298|Drug|Placebo|
16387108|NCT00051285|Drug|Enoximone|Participants receive oral enoximone
16387109|NCT00051285|Drug|Enoximone placebo|Participants receive placebo to match enoximone
16387110|NCT00051311|Procedure|Stem cell transplantation|Recipients will receive donor stem cells 3 days after conditioning therapy is completed.
16387111|NCT00051311|Drug|Fludarabine|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387112|NCT00051311|Drug|Cyclophosphamide|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387113|NCT00051311|Drug|Etoposide|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387114|NCT00051311|Drug|Doxorubicin|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387115|NCT00051311|Drug|Vincristine|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387116|NCT00051311|Drug|Prednisone|Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
16387117|NCT00051311|Drug|Methotrexate|Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD)..
16387118|NCT00051311|Drug|Cyclosporine|Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).
16387119|NCT00051311|Procedure|Apheresis|Donors will undergo apheresis to collect stem cells for a stem cell transplant for the recipient.
16387120|NCT00051272|Drug|Extended-release Bupropion Hydrochloride|
16387121|NCT00051259|Drug|Extended-Release Bupropion Hydrochloride|
16387122|NCT00051246|Behavioral|Mother-Infant Group Psychotherapy|Mother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks.
16387123|NCT00051246|Behavioral|Interpersonal Psychotherapy|Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.
16387124|NCT00051233|Procedure|World Wide Web-Based Psychoeducation|
16387125|NCT00051220|Behavioral|One-Session Treatment for Specific Phobias|
16387126|NCT00051207|Behavioral|Interpersonal Psychotherapy (IPT)|
16387127|NCT00051207|Behavioral|IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)|
16387128|NCT00051194|Drug|Combination IOP Lowering Therapy|
16387129|NCT00051181|Drug|Travoprost (0.004%)|
16387130|NCT00051181|Drug|Latanoprost (0.005%)|
16387131|NCT00051168|Drug|Travatan|Travoprost (0.004%) 1 drop each eye once daily
16387132|NCT00051155|Drug|Travoprost (0.004%)|
16387133|NCT00051155|Drug|Latanoprost (0.005%)/Timolol (0.5%)|
16387134|NCT00051142|Drug|Travoprost|
16387135|NCT00051142|Drug|Latanoprost|
16387136|NCT00051129|Drug|Anecortave Acetate 15 mg sterile suspension|0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
16387137|NCT00051129|Other|Anecortave Acetate Vehicle|Administered as a posterior juxtascleral injection
16387138|NCT00051116|Drug|CC-5013|
16387139|NCT00051103|Drug|Investigational Cancer Drug|
16387140|NCT00051090|Drug|Telbivudine|Administered orally at a daily dosage of 600 mg for a period of 48 weeks
16387141|NCT00051090|Drug|Lamivudine|Administered orally at a total daily dosage of 300 mg for Weeks 24-48
16387142|NCT00051090|Drug|Efavirenz|Administered orally at a daily dose of 600 mg
16387209|NCT00050518|Biological|Aventis Pasteur Smallpox Vaccine|
16387143|NCT00051090|Drug|Didanosine|Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
16387144|NCT00051090|Drug|Abacavir|Administered orally twice daily in doses of 300 mg
16387145|NCT00051077|Drug|Adefovir dipivoxil|
16387146|NCT00051077|Drug|Peginterferon-alfa-2A|
16387147|NCT00051077|Drug|Ribavirin|
16387148|NCT00051077|Procedure|Liver Biopsy|
16387149|NCT00051051|Drug|CI-1033|
16387150|NCT00051038|Drug|Entecavir|
16387151|NCT00051025|Drug|ONTAK|
16387152|NCT00051012|Drug|ONTAK|
16387153|NCT00050999|Drug|ONTAK|
16387154|NCT00050986|Drug|Temozolomide|Starting Dose Level: 100 mg/m^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period.
16387155|NCT00050986|Drug|R115777|Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 weeks.
16387156|NCT00050973|Drug|bexarotene|
16387157|NCT00050960|Drug|bexarotene with carboplatin and paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
16387158|NCT00050960|Drug|carboplatin and paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
16387159|NCT00050947|Drug|oxcarbazepine|
16387160|NCT00050934|Drug|oxcarbazepine|
16387161|NCT00050921|Drug|somatropin|
16387162|NCT00050921|Biological|Hepatitis A virus, inactivated|
16387163|NCT00050921|Drug|Keyhole-Limpet Hemocyanin|
16387164|NCT00050895|Drug|Lopinavir/ritonavir|
16387165|NCT00050895|Drug|Efavirenz|
16387166|NCT00050895|Drug|Stavudine|
16387167|NCT00050895|Drug|Zidovudine|
16387168|NCT00050895|Drug|Lamivudine|
16387169|NCT00050895|Drug|Tenofovir disoproxil fumarate|
16387170|NCT00050882|Drug|GM-611|
16387171|NCT00050856|Drug|Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor|
16387172|NCT00050843|Drug|thalidomide|
16387173|NCT00050830|Drug|CI 1033|
16387174|NCT00050817|Drug|clopidogrel (SR25990)|
16387175|NCT00050791|Drug|Leptin|Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight
16387176|NCT00050791|Behavioral|Very Low Calorie Diet|placebo injections
16387177|NCT00050778|Biological|Interferon beta-1a|Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months.
16387178|NCT00050778|Biological|Alemtuzumab 12 mg|Alemtuzumab 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
16387179|NCT00050778|Biological|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
16387180|NCT00050804|Drug|sertraline|
16387181|NCT00050765|Drug|MyoCell™ Autologous Myoblasts|
16387182|NCT00050687|Drug|Gallium maltolate|
16387183|NCT00050726|Drug|Interleukin-2|
16387184|NCT00050713|Drug|Sirolimus|
16387185|NCT00050674|Drug|Filgrastim-SD/01|6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)
16387186|NCT00050661|Drug|Daclizumab|Humanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses.
16387187|NCT00050661|Device|NB-UVB|total body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total.
16387188|NCT00050648|Drug|Daclizumab|1mg/kg medication every other week on the odd week (week 1-13).
16387189|NCT00050648|Drug|Cyclosporine|2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
16387190|NCT00050648|Drug|cyclosporine and Daclizumab|1mg/kg plus low dose cyclosporine (2 mg/kg/day)
16387191|NCT00050635|Drug|Sandostatin LAR Depot|
16387192|NCT00050609|Drug|tadalafil|5 mg tadalafil tablet taken by mouth once a day for 8 weeks
16387193|NCT00050609|Drug|tadalafil|20 mg tadalafil tablet taken by mouth once a day for 8 weeks
16387194|NCT00050609|Drug|placebo|Placebo tablet taken by mouth once a day for 8 weeks
16387195|NCT00050427|Drug|ET743|580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
16387196|NCT00050427|Drug|ET743|1,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
16387197|NCT00050622|Drug|Methylphenidate 0.15 mg/kg|0.15 m/kg/dose immediate-release methylphenidate
16387198|NCT00050622|Behavioral|Low-Intensity BMOD|Lower-intensity behavioral treatment package.
16387199|NCT00050622|Drug|Methylphenidate 0.3 mg/kg|0.3 mg/kg/dose immediate-release methylphenidate
16387200|NCT00050622|Drug|Placebo|
16387201|NCT00050622|Drug|Methylphenidate 0.6 mg/kg|0.3 mg/kg/dose immediate-release methylphenidate
16387202|NCT00050622|Behavioral|High Intensity BMOD|Comprehensive high-intensity Summer Treatment Program (STP)
16387203|NCT00050596|Drug|MDX-010 / MDX-010 + Docetaxel|
16387204|NCT00050583|Behavioral|Cognitive Behavioral Therapy|Ten Weekly Sessions of Manualized CBT
16387205|NCT00050583|Behavioral|CBT|Cognitive Behavioral Therapy
16387206|NCT00050570|Behavioral|Web-based intervention to reduce eating disorder risk factors|
16387207|NCT00050557|Behavioral|Multifamily Psychoeducation Group (MFPG)|MFPG will include 8 weekly 90-minute group therapy sessions.
16387208|NCT00050557|Behavioral|Treatment as usual (TAU)|Participants will receive standard care for mood disorders.
16387210|NCT00050505|Biological|Live vaccinia virus vaccine|Dryvax undiluted. Cohort A receives undiluted dose of Dryvax vaccine
16387211|NCT00050505|Biological|Live vaccinia virus vaccine|Dryvax with diluent (50% glycerin and 0.25% phenol in sterile water). Cohort A-C receives diluted dose of Dryvax vaccine.
16387212|NCT00050479|Drug|Celecoxib (Celebrex)|
16387213|NCT00050440|Drug|Trabectedin|Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
16387214|NCT00050440|Drug|Dexamethasone|Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose
16387215|NCT00050414|Drug|Trabectedin|Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.
16387216|NCT00050414|Drug|Dexamethasone|Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
16387217|NCT00050401|Drug|MERREM I.V. 2g as a 3 hour infusion every 8 hours|
16387218|NCT00050401|Drug|vancomycin I.V. 1 g every 12 hours|
16387219|NCT00050401|Drug|tobramycin I.V. 5 mg/kg every 24 hours|
16387220|NCT00050401|Drug|MERREM I.V. 1g as a 30 minute infusion every 8 hours|
16387221|NCT00050401|Drug|MERREM I.V. 500 mg as a 3 hour infusion every 8 hours|
16387222|NCT00011635|Drug|Silymarin (milk thistle)|
16387223|NCT00011063|Drug|Ginkgo Biloba|
16387224|NCT00009542|Drug|kava (Piper methysticum)|
16387225|NCT00006395|Drug|St. John's Wort|
16387226|NCT00006155|Drug|SU5416 and carboplatin|
16387227|NCT00006062|Drug|oxaliplatin|
16387228|NCT00005926|Drug|Gemcitabine|
16387229|NCT00005926|Drug|Herceptin|
16387230|NCT00005926|Procedure|Radiation therapy|
16387231|NCT00005912|Drug|Voriconazole|
16387232|NCT00005783|Drug|Recombinant-methionyl human stem cell factor|
16387233|NCT00005574|Drug|Gentamicin|
16387234|NCT00004576|Drug|LY300164|
16387235|NCT00001986|Drug|1-Octanol|
16387236|NCT00001968|Drug|Amprenavir|
16387237|NCT00001968|Drug|Ritonavir|
16387238|NCT00001968|Drug|Abacavir|
16387239|NCT00001968|Drug|Lamivudine|
16387240|NCT00001966|Drug|Mind-body therapy|
16387241|NCT00001965|Drug|Cyclosporine A|
16387242|NCT00001963|Procedure|hemoglobin-transported nitric oxide|
16387243|NCT00001944|Drug|Vinorelbine|
16387244|NCT00001944|Drug|XR9576|
16387245|NCT00001940|Drug|Voriconazole|
16387246|NCT00001937|Drug|FK463|
16387247|NCT00001937|Drug|Fluconazole|
16387248|NCT00001931|Drug|N-0923|
16387249|NCT00001930|Drug|Amantadine|
16387250|NCT00001929|Drug|Eliprodil|
16387251|NCT00001909|Drug|Soluble recombinantly produced IL-4R|
16387252|NCT00001906|Biological|Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants|
16387253|NCT00001903|Drug|RSV Polyclonal Immunoglobulin|
16387254|NCT00001891|Procedure|Myocardial contrast echocardiography|
16387255|NCT00001891|Procedure|Dobutamine echocardiography|
16387256|NCT00001890|Drug|Estrogen therapy|
16387257|NCT00001889|Procedure|Myocardial contrast echocardiography|
16387258|NCT00001889|Procedure|Stress echocardiography with dobutamine|
16387259|NCT00001886|Procedure|Real time 3-dimensional stress echocardiography|
16387260|NCT00001857|Drug|BG9588|
16387261|NCT00001839|Drug|Antithymocyte globulin|
16387262|NCT00001839|Drug|Cyclosporine|
16387263|NCT00001812|Drug|Nystatin|
16387264|NCT00001810|Drug|Voriconazole|
16387265|NCT00001805|Drug|Rituximab|
16387266|NCT00001797|Drug|Recombinant human interleukin-10|
16387267|NCT00001790|Drug|FK463|
16387268|NCT00001789|Drug|BG9588|
16387269|NCT00001777|Drug|Sertraline|
16387270|NCT00001768|Drug|Intravenous immunoglobulin|
16387271|NCT00001763|Drug|Interleukin-12|
16387272|NCT00001761|Drug|Interleukin-10|
16387273|NCT00001757|Drug|Voriconazole|
16387274|NCT00001753|Procedure|Magnetic resonance imaging|
16387275|NCT00001752|Drug|L-arginine|
16387276|NCT00001752|Drug|Estrogen|
16387277|NCT00001748|Procedure|Peripheral blood progenitor cell transplant|
16387278|NCT00001736|Drug|Cysteamine|
16387279|NCT00001735|Procedure|Gene therapy|
16387280|NCT00001731|Drug|Cyclosporin A|
16387281|NCT00001730|Drug|Thyrogen|
16387282|NCT00001718|Device|Electropalatography|
16387283|NCT00001705|Drug|GP100 peptide|
16387284|NCT00001705|Drug|IL-2|
16387285|NCT00001696|Drug|Genistein|
16387286|NCT00001685|Biological|Immunodominant peptides from three melanoma antigens, MART-1, GP100 and tyrosinase|
16387287|NCT00001680|Drug|Thalidomide|
16387288|NCT00001677|Drug|Methotrexate|
16387289|NCT00001677|Drug|Fludarabine|
16387290|NCT00001669|Drug|rhIGF-1 (CEP-151)|
16387291|NCT00001658|Drug|Amoxicillin|
16387292|NCT00001646|Drug|Voriconazole|
16387293|NCT00001646|Drug|Amphotericin B|
16387294|NCT00001633|Procedure|Coronary magnetic resonance angiography imaging|
16387295|NCT00001629|Drug|Angiotensin II type 1 receptor antagonists|
16387296|NCT00001628|Drug|Angiotensin II type 1 receptor antagonists|
16387297|NCT00001624|Drug|Insulin|
16387298|NCT00001622|Procedure|investigate the relationship between in vivo and in vitro vascular responses|
16387299|NCT00001615|Drug|Corticosteroid|
16387300|NCT00001614|Drug|Chicken type II collagen|
16387301|NCT00001605|Biological|Nontypeable Haemophilus influenzae|
16387302|NCT00001587|Procedure|Isolated hepatic portal and arterial perfusion|
16387303|NCT00001587|Drug|Melphalan|
16387304|NCT00001579|Drug|5-Fluorouracil|
16387305|NCT00001579|Drug|Ethynyluracil|
16387306|NCT00001579|Drug|Leucovorin|
16387307|NCT00001577|Procedure|double isolated limb perfusion with melphalan alone|
16387309|NCT00001570|Drug|PSC 833|
16387310|NCT00001570|Drug|vinblastine|
16387311|NCT00001565|Drug|phenylbutyrate|
16387312|NCT00001554|Device|intraoperative infrared (IR) neuroimaging|
16387313|NCT00001538|Biological|APL 400-003|
16387314|NCT00001533|Drug|cyclosporine|
16387315|NCT00001520|Drug|neostigmine|
16387316|NCT00001509|Drug|IFN-alpha with retinoic acid|
16387317|NCT00001502|Drug|RMP-7 and carboplatin|
16387318|NCT00001499|Drug|paclitaxel|
16387319|NCT00001499|Drug|cisplatin|
16387320|NCT00001499|Procedure|chest radiotherapy|
16387321|NCT00001498|Drug|methotrexate|
16387322|NCT00001498|Drug|leucovorin|
16387323|NCT00001498|Drug|5-fluorouracil|
16387324|NCT00001498|Drug|cyclophosphamide|
16387325|NCT00001498|Procedure|peripheral blood progenitor cell|
16387326|NCT00001498|Drug|paclitaxel|
16387327|NCT00001498|Drug|doxorubicin|
16387328|NCT00001495|Drug|irinotecan (CPT-11)|
16387329|NCT00001493|Genetic|peripheral blood progenitor cells carrying MDR1|
16387330|NCT00001482|Drug|Lamotrigine (Lamictal® (Registered Trademark)|
16387331|NCT00001482|Drug|Gabapentin (Neurontin® (Registered Trademark))|
16387332|NCT00001450|Drug|paclitaxel|
16387333|NCT00001450|Drug|cisplatin|
16387334|NCT00001449|Drug|gemcitabine|
16387335|NCT00001449|Drug|fluorodeoxyuridine|
16387336|NCT00001449|Drug|leucovorin|
16387337|NCT00001446|Drug|thalidomide|
16387338|NCT00001445|Biological|HIV-1 Immunogen|
16387339|NCT00001443|Drug|indinavir (MK-0639)|
16387340|NCT00001439|Biological|gp100 human melanoma peptide|
16387341|NCT00001438|Drug|all-trans-retinoic acid with IFN-alpha2a|
16387342|NCT00001437|Drug|pentoxifylline|
16387343|NCT00001436|Drug|OncoLAR® (Registered Trademark)|
16387344|NCT00001436|Drug|tamoxifen|
16387345|NCT00001431|Drug|gemcitabine|
16387346|NCT00001428|Drug|5-fluorouracil|
16387347|NCT00001427|Drug|9-aminocamptothecin|
16387348|NCT00001422|Drug|fludarabine|
16387349|NCT00001421|Drug|methimazole|
16387350|NCT00001416|Drug|CEREDASE™|
16387351|NCT00001402|Device|PET scan|
16387352|NCT00001387|Drug|paclitaxel|
16387353|NCT00001384|Drug|Adriamycin|
16387354|NCT00001384|Drug|cyclophosphamide|
16387355|NCT00001384|Drug|G-CSF|
16387356|NCT00001384|Drug|paclitaxel|
16387357|NCT00001383|Drug|PSC 833|
16387358|NCT00001383|Drug|paclitaxel|
16387359|NCT00001382|Biological|PROSTVAC|
16387360|NCT00001381|Drug|suramin|
16387361|NCT00001378|Drug|fenretinide|
16387362|NCT00001365|Drug|dextromethorphan|
16387363|NCT00001344|Drug|dextromethorphan|
16387364|NCT00001341|Drug|ZD1694 (TOMUDEX)|
16387365|NCT00001338|Drug|FLAC chemotherapy with GM-CSF|
16387366|NCT00001333|Drug|topotecan|
16387367|NCT00001332|Procedure|CHPP with cisplatin|
16387368|NCT00001318|Drug|interferon gamma|
16387369|NCT00001317|Drug|interferon-gamma|
16387370|NCT00001311|Device|heparin-surface modified intraocular lens|
16387371|NCT00001300|Drug|doxorubicin|
16387372|NCT00001300|Drug|ifosfamide|
16387373|NCT00001300|Drug|mesna|
16387374|NCT00001298|Drug|carboxypeptidase-G2|
16387375|NCT00001296|Drug|melphalan|
16387376|NCT00001296|Drug|tumor necrosis factor|
16387377|NCT00001296|Drug|interferon-gamma|
16387378|NCT00001296|Procedure|hyperthermic isolated limb perfusion|
16387379|NCT00001287|Drug|intravenous immunoglobulin (IVIg)|
16387380|NCT00001280|Drug|itraconazole|
16387381|NCT00001272|Drug|taxol|
16387382|NCT00001271|Drug|IgG-RFB4-SMPT-dgA|
16387383|NCT00001270|Drug|interleukin-1|
16387384|NCT00001269|Drug|IL-3|
16387385|NCT00001267|Drug|zidovudine|
16387386|NCT00001267|Drug|2',3'-dideoxyinosine|
16387387|NCT00001249|Drug|Yttrium-90 radiolabeled anti-Tac antibody|
16387388|NCT00001239|Drug|FLAC with GM-CSF|
16387389|NCT00001237|Drug|granulocyte-macrophage colony stimulating factor (GM-CSF)|
16387390|NCT00001217|Drug|pre-surgical chemotherapy|
16387391|NCT00001209|Drug|vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16|
16387392|NCT00001193|Procedure|high dose melphalan and autologous bone marrow transplantation|
16387393|NCT00001189|Procedure|radiotherapy|
16387394|NCT00001188|Procedure|radiation therapy following surgery|
16387395|NCT00050388|Genetic|Allovectin-7®|
16387396|NCT00050375|Drug|oregovomab|
16387397|NCT00050362|Drug|Rofecoxib and Bupivacaine|
16387398|NCT00050349|Drug|EPO906 epothilone B|
16387399|NCT00050336|Drug|Lonafarnib (SARASAR)|
16387400|NCT00050323|Drug|Allogeneic DCs and Autologous RCC Tumor Derived Cells|
16387401|NCT00050297|Drug|YM598|
16387402|NCT00050271|Drug|Acetyl-L-carnitine|
16387403|NCT00050245|Drug|Rituximab|
16387404|NCT00050232|Drug|AVP-923|
16387405|NCT00050141|Drug|ZARNESTRA, tipifarnib, R115777|
16387406|NCT00050206|Drug|Olanzapine|
16387407|NCT00050206|Drug|Placebo|
16387408|NCT00050167|Drug|Paclitaxel|80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
16387409|NCT00050167|Drug|Docetaxel|75 mg/m^2 by vein (IV) Over 1 Hour Once Every 3 Weeks
16387410|NCT00050167|Drug|Capecitabine|1500 mg/m^2 by mouth Twice Daily x 2 Weeks
16387411|NCT00050180|Drug|Midazolam|
16387412|NCT00050180|Drug|Indinavir|
16387413|NCT00050180|Drug|Saquinavir|
16387414|NCT00050154|Drug|ZARNESTRA, tipifarnib, R115777|
16387415|NCT00050128|Device|rTMS, Magstim|
16387416|NCT00050102|Drug|MDX-010 (CTLA-4)|
16387417|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
16387706|NCT00045981|Drug|ALT-711|
16387418|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
16387419|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
16387420|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
16387421|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
16387422|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
16387423|NCT00050089|Other|No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP|Continuation or interruption of ART treatment
16387424|NCT00050089|Drug|Standard ART vs Mega ART|Standard therapy vs Intensified therapy
16387425|NCT00050076|Drug|MCC-135|MCC-135 50 mg, tablets, orally, twice daily for up to 12 weeks
16387426|NCT00050076|Drug|MCC-135|MCC-135 100 mg, tablets, orally, once daily for up to 12 weeks
16387427|NCT00050076|Drug|MCC-135|MCC-135 200 mg, tablets, orally, once daily for up to 12 weeks
16387428|NCT00050076|Drug|Placebo|MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
16387429|NCT00050063|Biological|Therapeutic vaccinations from A5058s|Participants will receive assigned interventions assigned in study A5058s.
16387430|NCT00050050|Behavioral|Cognitive behavioral therapy|
16387431|NCT00050050|Drug|Drug therapy|
16387432|NCT00050037|Procedure|CBT|
16387433|NCT00050011|Drug|Zoledronic Acid|Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months.
16387434|NCT00050011|Drug|Letrozole|Participants received Letrozole 2.5 mg daily.
16387435|NCT00049998|Drug|topotecan|
16387436|NCT00049985|Drug|Darbepoetin Alfa|
16387437|NCT00049972|Drug|paroxetine CR|
16387438|NCT00049959|Drug|verteporfin PDT|
16387439|NCT00049946|Drug|talnetant|
16387440|NCT00049946|Drug|risperidone|
16387441|NCT00049842|Biological|peginterferon alfa-2b (SCH 54031)|0.5 µg/kg Weekly QW SC for 36 months
16387442|NCT00049829|Drug|Zoledronic Acid|
16387443|NCT00049816|Behavioral|Walking exercise|30 minutes/day, 3 times/week for 52 weeks
16387444|NCT00049816|Behavioral|Cycling Exercise|30 minutes/day, 3 times/week for 52 weeks
16387445|NCT00049803|Drug|sodium oxybate|
16387446|NCT00049790|Drug|recombinant human Angiostatin protein|
16387447|NCT00049790|Drug|paclitaxel|
16387448|NCT00049790|Drug|carboplatin|
16387449|NCT00049777|Drug|Drotrecogin Alfa (Activated)|
16387450|NCT00049777|Drug|Unfractionated heparin|
16387451|NCT00049777|Drug|Low molecular weight heparin|
16387452|NCT00049764|Drug|Drotrecogin alfa (activated)|
16387453|NCT00049764|Drug|Placebo|
16387454|NCT00049751|Drug|Adalimumab|
16387455|NCT00048945|Drug|PEGASYS|
16387456|NCT00049725|Drug|Daclizumab|
16387457|NCT00048932|Drug|Double-blind Abatacept|Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Day 1, 15, and 29.
16387458|NCT00048932|Drug|Double-blind Placebo|Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.
16387459|NCT00048932|Drug|Open-label Abatacept|Concentrate and diluted in a solution, IV, 500 mg (body weight < 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight > 100 Kg), Once daily, Every 28 days.
16387460|NCT00048854|Drug|Sertraline|Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
16387461|NCT00048854|Other|Treatment as usual (TAU)|At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.
16387462|NCT00048841|Drug|alendronate|
16387463|NCT00048828|Drug|Olanzapine|Participants will receive olanzapine for 12 weeks.
16387464|NCT00048828|Drug|Clozapine|Participants will receive 12 weeks of clozapine.
16387465|NCT00048815|Drug|Citalopram|Established Selective Serotonin Reuptake Inhibitor antidepressant
16387466|NCT00048815|Drug|St. John's Wort|Natural extract from the St. John's Wort plant.
16387467|NCT00048815|Drug|Placebos|Placebo pill
16387468|NCT00048802|Drug|Lithium|
16387469|NCT00048802|Drug|Olanzapine|
16387470|NCT00048802|Drug|Divalproex|
16387471|NCT00048802|Drug|Risperidone|
16387472|NCT00048802|Drug|Quetiapine|
16387473|NCT00048802|Drug|Ziprasidone|
16387474|NCT00048802|Drug|Aripriprazole|
16387475|NCT00048581|Drug|Abatacept|Vials, intravenous (IV), ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
16387476|NCT00048581|Drug|Placebo|Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
16387477|NCT00048581|Drug|Abatacept|Vials, IV, ~10mg/kg abatacept, every 4 weeks, 5.5 years
16387478|NCT00048568|Drug|Abatacept|Intravenous (IV) Solution, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
16387479|NCT00048568|Drug|Methotrexate|Tablets, Oral, >= 15 mg, weekly, 1 year
16387480|NCT00048568|Drug|Placebo|IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
16387481|NCT00048906|Drug|DRX005B|
16387482|NCT00048893|Biological|recombinant fowlpox-CEA(6D)/TRICOM vaccine|4 x 10^8 pfu given monthly subcutaneously for three doses in the first series and three doses on each of the intermediate and late re-immunizations (total 9 doses).
16387483|NCT00048893|Biological|recombinant vaccinia-CEA(6D)/TRICOM vaccine|rV-CEA (6D)/Tricom concomitantly with sargramostim (rGM-CSF). 1.2 x 10^8 pfu x 1 dose subcutaneously.
16387484|NCT00048893|Biological|filgrastim|5 mcg/kg/day subcutaneously
16387485|NCT00048893|Biological|sargramostim|100 mcg daily for 4 consecutive days at the same site as the rF-CEA (6D)/Tricom vaccine. The first dose will be given with the vaccine.
16387552|NCT00048165|Drug|Mycophenolate mofetil|Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.
16388918|NCT00029458|Drug|Clozapine|
16387486|NCT00048893|Drug|cyclophosphamide|"First induction chemotherapy: 2700 mg/m^2 per cycle (900 mg/m^2 per day intravenous over 1 hour for 3 consecutive days, days 1-3).
~Second induction: 600 mg/m^2 per cycle (600 mg/m^2 intravenous over 1 hour day 1.
~Immune depleting chemotherapy: 2400 mg/m^2 per cycle (600 mg/m^2 per day intravenous over 1 hour for 4 consecutive days, days 1-4)."
16387487|NCT00048893|Drug|doxorubicin hydrochloride|60 mg/m^2 per cycle (60 mg/m^2 slow intravenous push day 1).
16387488|NCT00048893|Drug|fludarabine phosphate|120 mg/m^2 (30 mg/m^2 per day intravenous over 30 minutes for 4 consecutive days (days 1-4)).
16387489|NCT00048893|Drug|paclitaxel|160 mg/m^2 per cycle (53.3 mg/m^2 per day by continuous intravenous infusion over 24 hours for 3 consecutive days 1-3).
16387490|NCT00048893|Drug|Mesna|"Percent equals fraction of total daily cyclophosphamide dose. Initial: 20% of cyclophosphamide dose given intravenously (IV) mixed with cyclophosphamide.
~3 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO) 6 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO) 9 hours post completion of cyclophosphamide: 20% intravenously (IV) or 40% by mouth (PO)"
16387491|NCT00048880|Drug|HeFi-1 Monoclonal Antibody|
16387492|NCT00048776|Drug|Pletal|
16387493|NCT00048763|Drug|Pletal|
16387494|NCT00048789|Procedure|Extracorporeal Photopheresis|
16387495|NCT00048750|Drug|Micafungin|IV
16387496|NCT00048750|Drug|Placebo|IV
16387497|NCT00048737|Drug|Zevalin Radioimmunotherapy|Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
16387498|NCT00048737|Drug|Rituximab|250 mg/m^2 on day 1 and day 8
16387499|NCT00048737|Drug|Fludarabine|30 mg/m^2/day for 3 days
16387500|NCT00048737|Drug|Cyclophosphamide|750 mg/m^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
16387501|NCT00048737|Procedure|Allogeneic Stem Cell Transplantation|Allogeneic stem cell transplantation 2 days after chemotherapy
16387502|NCT00048724|Biological|peginterferon alfa-2b (SCH 54031)|0.5 µg/kg subcutaneously once weekly for 60 months
16387503|NCT00048711|Drug|N-acetylgalactosamine 4-sulfatase|
16387504|NCT00048698|Procedure|TMS|
16387505|NCT00048698|Procedure|EEG|
16387506|NCT00048672|Drug|Gleevec|Starting dose of 400 mg orally daily.
16387507|NCT00048659|Drug|YM598|
16387508|NCT00048646|Drug|IV Progesterone|
16387509|NCT00048633|Drug|Chemotherapy|
16387510|NCT00048620|Drug|N-acetylgalactosamine 4-sulfatase|
16387511|NCT00048607|Drug|aprepitant|
16387512|NCT00048607|Drug|Comparator: paroxetine HCL|
16387513|NCT00048607|Drug|Comparator: Placebo (Unspecified)|
16387514|NCT00048594|Drug|aprepitant|
16387515|NCT00048594|Drug|Comparator: placebo (unspecified)|
16387516|NCT00048555|Drug|IDEC-114|Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions
16387517|NCT00048542|Biological|Double-Blind Adalimumab/Placebo + MTX|Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.
16387518|NCT00048542|Biological|Double-Blind Adalimumab/Placebo|Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.
16387519|NCT00048542|Drug|OLE BSA Adalimumab +/- MTX|Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.
16387520|NCT00048542|Drug|OLE FD Adalimumab +/- MTX|Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.
16387521|NCT00048529|Drug|T900607-sodium intravenous|
16387522|NCT00048516|Drug|paricalcitol capsule|
16387523|NCT00048503|Drug|ZARNESTRA, tipifarnib, R115777|
16387524|NCT00048464|Procedure|Infusion of Activated & Expanded Autologous T Cells|
16387525|NCT00048451|Drug|paricalcitol|
16387526|NCT00048438|Drug|paricalcitol|
16387527|NCT00048425|Drug|Levosimendan|
16387528|NCT00048490|Device|transcranial magnetic stimulation (TMS)|
16387529|NCT00048477|Drug|L-NMMA and Sodium Nitrite|
16387530|NCT00048412|Drug|FLUDARABINE|
16387531|NCT00048412|Drug|CAMPATH 1H|
16387532|NCT00048412|Drug|FK50|
16387533|NCT00048412|Procedure|Stem Cell Collection and Infusion|
16387534|NCT00048399|Drug|Fludarabine|
16387535|NCT00048399|Drug|CAMPATH 1H|
16387536|NCT00048399|Drug|FK506|
16387537|NCT00048399|Procedure|Stem Cell Transplantation|
16387538|NCT00048386|Biological|autologous neuroblastoma vaccine|A vaccine dose of 0.3 x 108 IL-2 secreting cells/patient/injection will be used. Injections will be given twice monthly for two months, then monthly for four months, for a total of eight vaccine injections over six months.
16387539|NCT00048373|Drug|Etanercept|
16387540|NCT00048360|Drug|Extended-release bupropion hydrochloride|
16387541|NCT00048321|Drug|ISIS 104838|
16387542|NCT00048308|Drug|pexelizumab|
16387543|NCT00048347|Drug|AVONEX|30µg IM every week for 12 weeks
16387544|NCT00048334|Drug|Depsipeptide, FR901228, FK228|
16387545|NCT00048295|Drug|Alicaforsen|
16387546|NCT00048230|Drug|bortezomib|
16387547|NCT00048217|Drug|T-1249|
16387548|NCT00048204|Drug|GW597599B|
16387549|NCT00048204|Drug|paroxetine|
16387550|NCT00048165|Drug|Daclizumab|Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
16387551|NCT00048165|Drug|Methylprednisolone|Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).
16387553|NCT00048165|Drug|Placebo|Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
16387554|NCT00048165|Drug|cyclosporine|Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.
16387555|NCT00048152|Drug|Corticosteroids|As prescribed
16387556|NCT00048152|Drug|Neoral|Low dose (target trough level 50-100ng/mL)
16387557|NCT00048152|Drug|Neoral|Standard dose (target trough level 150-300ng/mL)
16387558|NCT00048152|Drug|Zenapax|2mg/kg iv first dose, then 1mg/kg every 2 weeks
16387559|NCT00048152|Drug|mycophenolate mofetil [CellCept]|1g po bid
16387560|NCT00048139|Drug|Irinotecan|250mg/m2 iv on day 1 of each 3 week cycle
16387561|NCT00048139|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-15 of each 3 week cycle
16387562|NCT00048126|Drug|Irinotecan|100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
16387563|NCT00048126|Drug|capecitabine [Xeloda]|1000mg po bid
16387564|NCT00048113|Drug|Alicaforsen|
16387565|NCT00048100|Procedure|Apheresis|Apheresis for T-Cell collection
16387566|NCT00048100|Biological|Stem Cell Transplant|Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
16387567|NCT00048087|Drug|ZD1839|250 mg by mouth daily each day for 4 weeks.
16387568|NCT00048087|Drug|Docetaxel|30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
16387569|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|2mg iv every 2 months
16387570|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|2.5mg po daily
16387571|NCT00048074|Drug|ibandronate [Bonviva/Boniva]|3mg iv every 3 months
16387572|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|2.5mg po daily
16387573|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|100mg po monthly on a single day
16387574|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|100mg po monthly over 2 consecutive days
16387575|NCT00048061|Drug|Ibandronate [Bonviva/Boniva]|150mg po monthly
16387576|NCT00048061|Dietary Supplement|Calcium|500 mg/day
16387577|NCT00048061|Dietary Supplement|Vitamin D|400 IU/day
16387578|NCT00048048|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of sc administration
16387579|NCT00048035|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Differing doses and frequencies of iv administration
16387580|NCT00048022|Drug|Dual Integrin Antagonist|
16387581|NCT00048009|Drug|Dual Integrin Antagonist|
16387582|NCT00047983|Dietary Supplement|Canola oil|
16387583|NCT00047983|Dietary Supplement|Arginine|
16387584|NCT00047983|Dietary Supplement|Fish oil emulsion|
16387585|NCT00047840|Drug|ZD6474|
16387586|NCT00047840|Drug|Placebo|
16387587|NCT00047840|Drug|Docetaxel|
16387588|NCT00047827|Drug|Micafungin|IV
16387589|NCT00047827|Drug|Liposomal Amphotericin B|IV
16387590|NCT00047814|Drug|FK788|
16387591|NCT00047931|Drug|VRC-HIVDNA009-00-VP|
16387592|NCT00047905|Behavioral|examine the process of prenatal genetic counseling|
16387593|NCT00047879|Biological|PEG-interferon alfa-2b|0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection
16387594|NCT00047879|Drug|Thalidomide|Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.
16387597|NCT00047801|Drug|TLK286 in combination with docetaxel|
16387598|NCT00047788|Drug|ZD6474|
16387599|NCT00047788|Drug|VEGF-receptor tyrosine kinase (KDR)|
16387600|NCT00047775|Drug|BiDil|
16387601|NCT00047762|Drug|Erlotinib (aka Tarceva or OSI-774)|
16387602|NCT00047762|Drug|Bevacizumab (aka Avastin or Rhu MAb VEGF)|
16387603|NCT00047554|Drug|Travoprost, 0.004% ophthalmic solution|
16387604|NCT00047541|Drug|Alcon Investigational Agent|
16387605|NCT00047528|Drug|Alcon Investigational Agent|
16387606|NCT00047515|Drug|Alcon Investigational Agent|
16387607|NCT00047749|Drug|Prialt (ziconotide)|
16387608|NCT00047736|Drug|Tarceva (erlotinib HCl)|
16387609|NCT00047723|Drug|minocycline|
16387610|NCT00047710|Drug|Bevacizumab|Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
16387611|NCT00047710|Drug|Capecitabine|650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
16387612|NCT00047710|Radiation|Radiotherapy|Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
16387613|NCT00047697|Drug|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
16387614|NCT00047697|Drug|Placebo|Placebo used in placed of Donepezil HCL
16387615|NCT00047684|Behavioral|Brief Integrative Therapy|
16387616|NCT00047671|Drug|Citalopram|PDA Approved antidepressant
16387617|NCT00047658|Drug|Interferon-gamma 1b|200 mcg, SQ, 3x per week
16387618|NCT00047645|Drug|Interferon-gamma 1b|200 mcg, SQ, 3x per week
16387619|NCT00047632|Drug|Interferon gamma-1b|100 mcg, SQ, 3x per week
16387620|NCT00047606|Drug|IOP Lowering Medications|
16387621|NCT00047593|Drug|IOP Lowering Medications|
16387622|NCT00047619|Procedure|Pulsatile Lavage|pulsatile lavage to wound bed
16387623|NCT00047619|Other|sham pulsatile lavage|pulsatile lavage to not directed at wound or patient
16387624|NCT00047580|Drug|tizanidine hydrochloride capsule|
16387625|NCT00047567|Drug|zonisamide|
16387626|NCT00046371|Drug|THERATOPE® vaccine|
16387627|NCT00047502|Drug|Lonafarnib (SCH66336)|"Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.
~Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.
~Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day."
16387628|NCT00047502|Drug|Imatinib Mesylate (Gleevec)|"Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day.
~Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day."
16387629|NCT00047489|Drug|ABT-751|
16387630|NCT00047476|Drug|dexmethylphenidate(d-mph)|
16387631|NCT00047463|Device|continuous positive airway pressure (CPAP)|a mask treatment for sleep apnea
16387632|NCT00047463|Device|Placebo-CPAP|Placebo-CPAP
16387633|NCT00047450|Drug|Citalopram (Celexa)|Citalopram for 3 months
16387634|NCT00047450|Drug|Placebo|Placebo for 3 months
16387635|NCT00047437|Behavioral|Supervised Exercise Training Program|Exercise 30 minutes minimum three times per week.
16387636|NCT00047411|Other|Cardiopulmonary Resuscitation|Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines
16387637|NCT00047411|Device|Automatic External Defibrillation|Use the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.
16387638|NCT00046800|Drug|OSI-211 (Liposomal Lurtotecan)|
16387639|NCT00046787|Drug|OSI-211 (Liposomal Lurtotecan)|
16387640|NCT00046761|Drug|ONO-2506|
16387641|NCT00046748|Drug|Omalizumab|
16387642|NCT00046813|Drug|Nicotine patch|
16387643|NCT00046774|Drug|MRA 003 US|
16387644|NCT00046735|Drug|Lenalidomide|The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT
16387645|NCT00046722|Drug|Smoked Marijuana|
16387646|NCT00046527|Drug|ABI-007|
16387647|NCT00046514|Drug|ABI-007|
16387648|NCT00046423|Drug|ABI-007|
16387649|NCT00046709|Drug|Smoked Marijuana|
16387650|NCT00046696|Drug|NM-3|
16387651|NCT00046683|Drug|alemtuzumab|
16387652|NCT00046540|Drug|Liposome-encapsulated SN38|
16387653|NCT00046501|Drug|Lantus (insulin glargine [rDNA origin] injection)|
16387654|NCT00046501|Drug|Humulin N|
16387655|NCT00046501|Drug|Humulin L|
16387656|NCT00046501|Drug|Lispro|
16387657|NCT00046488|Drug|IDEC-152|6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
16387658|NCT00046475|Drug|Midodrine Hydrochloride|
16387659|NCT00046462|Drug|Lantus (insulin glargine [rDNA origin] injection)|
16387660|NCT00046462|Drug|Metformin|
16387661|NCT00046462|Drug|Glyburide|
16387662|NCT00046462|Drug|Thiazolidinedione|
16387663|NCT00046449|Drug|Investigational Seasonal Affective Disorder (SAD) Drug|
16387664|NCT00046566|Dietary Supplement|Soy protein-milk protein-carbohydrate|40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks
16387665|NCT00046566|Dietary Supplement|Milk protein-carbohydrate-soy protein|40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.
16387666|NCT00046566|Behavioral|Carbohydrate-soy protein-milk protein|40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks,
16387667|NCT00046553|Drug|RU-486 (Mifepristone)|
16387668|NCT00046384|Drug|aripiprazole|
16387669|NCT00046397|Drug|Modified Vaccinia Virus Ankara TBC-M|
16387670|NCT00046345|Drug|Atazanavir (BMS-232632)|
16387671|NCT00046332|Drug|GW810781|
16387672|NCT00046319|Drug|BSF 208075|
16387673|NCT00046306|Drug|Antioxidants|
16387674|NCT00046358|Drug|Lovostatin|
16387675|NCT00046358|Drug|Ibuprofen|
16387676|NCT00046293|Drug|Reopro|
16387677|NCT00046293|Drug|Retrovase|
16387678|NCT00046267|Drug|Niacin|
16387679|NCT00046254|Drug|Zoledronic Acid|
16387680|NCT00046241|Drug|Extended-release bupropion hydrochloride|
16387681|NCT00046228|Drug|abciximab placebo; reteplase placebo, abciximab, abciximab|placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
16387682|NCT00046228|Drug|Abciximab; reteplase; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
16387683|NCT00046228|Drug|abciximab; reteplase placebo; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
16387684|NCT00046228|Drug|abciximab placebo; reteplase placebo, abciximab, abciximab|placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
16387685|NCT00046228|Drug|abciximab; reteplase placebo; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
16387686|NCT00046228|Drug|Abciximab; reteplase; abciximab placebo; abciximab|0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
16387687|NCT00046176|Drug|abacavir/lamivudine|
16387688|NCT00046176|Drug|abacavir|
16387689|NCT00046176|Drug|lamivudine|
16387690|NCT00046163|Drug|midodrine hydrochloride (ProAmatine®)|
16387691|NCT00046150|Drug|Insulin glulisine (HMR1964)|
16387692|NCT00046137|Drug|teriparatide|
16387693|NCT00046137|Drug|raloxifene|
16387694|NCT00046137|Drug|placebo|
16387695|NCT00046111|Drug|topotecan|A topoisomerase I inhibitor used for ovarian and lung cancer treatment
16387696|NCT00046085|Behavioral|Online Family Education|Families were provided with private, secure access to the website, which features family-to-family chat capabilities, video lectures on the management of schizophrenia, written materials on important issues in schizophrenia management, professionally facilitated online discussions of the material, and additional resource links.
16387697|NCT00046085|Behavioral|Customary care|Participants received care as usual.
16387698|NCT00046072|Drug|E5564|
16387699|NCT00046033|Drug|Lopinavir/ritonavir|
16387700|NCT00046033|Drug|Ritonavir|
16387701|NCT00046033|Drug|Saquinavir|
16387702|NCT00046033|Drug|Tenofovir disoproxil fumarate|
16387703|NCT00046033|Drug|Amprenavir|
16387704|NCT00046020|Drug|Venlafaxine ER|
16387705|NCT00045994|Drug|ALT-711|
16387707|NCT00045968|Drug|Dendritic cell immunotherapy|Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.
16387708|NCT00045955|Drug|Fexofenadine, Comparator = Montelukast|
16387709|NCT00045942|Drug|Itraconazole|Itraconazole was commercially available.
16387710|NCT00045942|Drug|PKC412|PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412.
16387711|NCT00045916|Procedure|High dosage electroconvulsive therapy|Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
16387712|NCT00045916|Drug|Nortriptyline|Participants will receive nortriptyline.
16387713|NCT00045916|Drug|Venlafaxine|Participants will receive venlafaxine.
16387714|NCT00045916|Drug|Lithium|Participants will receive lithium.
16387715|NCT00045916|Procedure|Low dosage electroconvulsive therapy|Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
16387716|NCT00045903|Behavioral|Exposure and Ritual Prevention (Cognitive Behavioral Therapy)|
16387717|NCT00045903|Behavioral|Stress Management Therapy (Cognitive Behavior Therapy)|
16387718|NCT00044824|Drug|Fexofenadine|
16387719|NCT00044811|Drug|Fexofenadine|
16387720|NCT00045877|Drug|Recombinant Human Interleukin-2 and Rituximab|
16387721|NCT00045864|Drug|Recombinant Human Interleukin-2 and Rituximab|
16387722|NCT00045838|Drug|VCR-HIVDNA006-00-VP|
16387723|NCT00045812|Drug|SCH-58235|
16387724|NCT00045799|Drug|Omeprazole sodium bicarbonate immediate release PWD/FS|
16387725|NCT00045799|Drug|Cimetidine IV|
16387726|NCT00045786|Drug|CC-1088|400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
16387727|NCT00045773|Drug|Sertraline|50 - 200mg, once per day for 12 weeks.
16387728|NCT00045760|Drug|Drotrecogin alfa (activated)|
16387729|NCT00044928|Drug|Piperacillin/Tazobactam|
16387730|NCT00044915|Drug|Repinotan HCl (BAYX3702)|All patients receive 1.25 mg of repinotan
16387731|NCT00044915|Drug|Placebo|All patients receive 1.25 mg of placebo
16387732|NCT00044902|Drug|epratuzumab|
16387733|NCT00044889|Drug|clofarabine (IV formulation)|
16387734|NCT00044863|Biological|Erbitux (Cetuximab)|400 mg/m2 initial dose, 250 mg/m2 weekly
16387735|NCT00044837|Drug|Medroxyprogesterone acetate|
16387736|NCT00044837|Drug|Estradiol|
16387737|NCT00044876|Drug|CDB-2914|
16387738|NCT00044798|Procedure|Repetitive transcranial magnetic stimulation (rTMS)|Participants will receive 15 treatments of rTMS over 3 weeks.
16387739|NCT00044798|Drug|Citalopram|After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
16387740|NCT00044798|Procedure|Sham rTMS|Participants will receive 15 treatments of sham rTMS over 3 weeks.
16387741|NCT00044785|Drug|triacetyluridine|
16387742|NCT00044785|Drug|fluorouracil|
16387743|NCT00044785|Drug|leucovorin|
16387744|NCT00044785|Drug|camptosar|
16387745|NCT00044772|Drug|Venlafaxine ER|
16387746|NCT00044759|Drug|Piperacillin/Tazobactam (Tazocin)|
16387747|NCT00044746|Drug|Piperacillin/Tazobactam|
16387748|NCT00044733|Drug|Mylotarg (gemtuzumab ozogamicin) Injection|
16387749|NCT00044720|Drug|Rapamune|
16387750|NCT00044707|Drug|Pramlintide acetate|Clear, colorless, sterile solution for SC injection.
16387751|NCT00044694|Drug|Placebo 0.01 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
16387752|NCT00044694|Drug|Placebo 0.02 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
16387753|NCT00044694|Drug|Placebo 0.03 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
16387754|NCT00044694|Drug|Placebo 0.04 mL|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
16387755|NCT00044694|Drug|AC2993 2.5 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
16387756|NCT00044694|Drug|AC2993 5.0 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
16387757|NCT00044694|Drug|AC2993 7.5 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
16387758|NCT00044694|Drug|AC2993 10.0 mcg|2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
16387759|NCT00044681|Drug|risperidone|
16387760|NCT00044668|Drug|AC2993|Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.
16387761|NCT00044655|Drug|Risperidone|As prescribed by routine prescriber (not dictated by study protocol)
16387762|NCT00044655|Drug|Olanzapine|As prescribed by routine prescriber (not dictated by study protocol)
16387763|NCT00044655|Drug|Ziprasidone|As prescribed by routine prescriber (not dictated by study protocol)
16387764|NCT00044655|Drug|Quetiapine|As prescribed by routine prescriber (not dictated by study protocol)
16387765|NCT00044655|Drug|Aripiprazole|As prescribed by routine prescriber (not dictated by study protocol)
16387766|NCT00044642|Drug|Lorazepam|
16387767|NCT00044629|Behavioral|Cognitive-Behavioral Therapy for Insomnia|
16387768|NCT00044629|Drug|zolpidem tartrate (Ambien)|
16387769|NCT00044629|Drug|Placebo|
16387770|NCT00044616|Drug|Fluoxetine|
16387771|NCT00044616|Drug|Lithium|
16387772|NCT00044577|Drug|abacavir/lamivudine|
16387773|NCT00044577|Drug|abacavir|
16387774|NCT00044577|Drug|lamivudine|
16387775|NCT00044577|Drug|tenofovir|
16387776|NCT00044564|Drug|Bay 59-8862|75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal
16388042|NCT00041925|Drug|CGT003 (E2F Duplex Decoy)|
16387777|NCT00044551|Drug|Taxane (Cytotoxic, BAY59-8862)|Daily 1 h infusion every 3 weeks
16387778|NCT00044538|Drug|BAY59-8862 (Cytotoxic Taxane)|Intravenous dose over 60 minutes every 3 weeks
16387779|NCT00044525|Drug|BAY59-8862 (Cytotoxic Taxane)|1 h intravenous infusion every 3 weeks
16387780|NCT00044512|Drug|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
16387781|NCT00044486|Drug|Posaconazole oral suspension|
16387782|NCT00044473|Drug|levofloxacin|
16387783|NCT00044460|Drug|rosiglitazone|
16387784|NCT00044447|Drug|Glimepiride|
16387785|NCT00044434|Drug|bupropion (Wellbutrin)|
16387786|NCT00044421|Drug|Ruboxistaurin mesylate|
16387787|NCT00044408|Drug|Ruboxistaurin mesylate|
16387788|NCT00044395|Drug|Ruboxistaurin mesylate|
16387789|NCT00044382|Drug|CC-5013|
16387790|NCT00044369|Procedure|Varicocele repair|
16387791|NCT00044356|Genetic|Allovectin-7®|
16387792|NCT00044343|Drug|lapatinib|
16387793|NCT00044291|Drug|atamestane|
16387794|NCT00044291|Drug|toremifene|
16387795|NCT00044291|Drug|letrozole|
16387796|NCT00044291|Drug|aromatase inhibition|
16387797|NCT00044291|Procedure|hormone therapy|
16387798|NCT00044291|Procedure|endocrine therapy|
16387799|NCT00044291|Procedure|antiestrogen therapy|
16387802|NCT00044278|Drug|lamotrigine|
16387803|NCT00044265|Drug|ramipril|
16387804|NCT00044226|Drug|ML-04A|
16387805|NCT00044213|Drug|EDTA|Participants will receive 40 infusions of standard chelation solution.
16387806|NCT00044213|Drug|EDTA Placebo|Participants will receive 40 infusions of EDTA placebo.
16387807|NCT00044213|Dietary Supplement|High Dose Vitamin|
16387808|NCT00044213|Dietary Supplement|High Dose Vitamin Placebo|
16387809|NCT00044187|Drug|Sibutramine|
16387810|NCT00044148|Drug|LY333531|
16387811|NCT00044135|Drug|clevudine (drug)|
16387812|NCT00044070|Drug|YM872 (zonampanel)|
16387813|NCT00044057|Drug|YM872 (zonampanel), t-PA (alteplase)|
16387814|NCT00044044|Drug|Lurasidone 20 mg|Lurasidone 20mg/day tablets
16387815|NCT00044044|Drug|Lurasidone 40mg|Lurasidone 40mg/day tablets
16387816|NCT00044044|Drug|Lurasidone 80 mg|Lurasidone 80mg/day - 2 40mg tablets
16387817|NCT00044044|Drug|Haloperidol 10mg|Haloperidol 10mg/day tablets
16387818|NCT00044044|Drug|Placebo|Matching Placebo to Lurasdione and Haloperidol
16387819|NCT00044031|Biological|G17DT Immunogen|
16387820|NCT00044018|Drug|CDC-501|
16387821|NCT00044005|Drug|Lurasidone 20 mg|Lurasidone 20mg oral tablet taken once daily for 6-months
16387822|NCT00044005|Drug|Lurasidone 40 mg|Lurasidone 40mg oral tablets taken once daily
16387823|NCT00044005|Drug|Lurasidone 80mg|Lurasidone 80mg oral tablet taken once daily
16387824|NCT00043329|Drug|Actimmune Registry|as administered by physician
16387825|NCT00044109|Device|Magnets|
16387826|NCT00044083|Other|Placebo|Placebo: One capsule 3 times a day from Day 1 to Day 7
16387827|NCT00044083|Drug|Tolcapone|Tolcapone: One capsule 3 times a day from Day 1 to Day 7
16387828|NCT00043966|Drug|Lopinavir/ritonavir|
16387829|NCT00043966|Drug|Tenofovir DF|
16387830|NCT00043966|Drug|Emtricitabine|
16387831|NCT00043953|Drug|Lopinavir/ritonavir|
16387832|NCT00043953|Drug|Saquinavir mesylate|
16387833|NCT00043953|Drug|Lamivudine/zidovudine|
16387834|NCT00043888|Drug|fosamprenavir|
16387835|NCT00043888|Drug|COMBIVIR|
16387836|NCT00043888|Drug|ritonavir|
16387837|NCT00043888|Drug|TRIZIVIR|
16387838|NCT00043979|Drug|F-18 Fluorodeoxyglucose|
16387839|NCT00043979|Biological|therapeutic allogeneic lymphocytes|Lymphocyte cells are collected from a healthy donor by apheresis and infused into the patient with a central venous catheter.
16387840|NCT00043979|Drug|cyclophosphamide|"Induction - 750 mg/m^2 intravenous (IV) infusion over 30 minutes x 1 dose. Day 5.
~Transplant - 1200 mg/m^2 per day IV infusion over 2 hours daily for 4 days; days -6, -5, -4, -3."
16387841|NCT00043979|Drug|cyclosporine|6 mg/kg per dose orally every other day (no day 9 dose).
16387842|NCT00043979|Drug|doxorubicin hydrochloride|Induction - 10 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
16387843|NCT00043979|Drug|etoposide|50 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days. Days 1, 2, 3, 4.
16387844|NCT00043979|Drug|fludarabine phosphate|"Induction - 25 mg/m^2 per day intravenous (IV) infusion over 30 minutes daily for 3 days. Days 1, 2, 3.
~Transplant - 30 mg/m^2 per day IV infusion over 30 minutes daily for 4 days; days -6, -5, -4, -3."
16387845|NCT00043979|Drug|melphalan|Transplant - 100 mg/m^2 per day intravenous (IV) infusion over 15 minutes for 1 day; day -2.
16387846|NCT00043979|Drug|prednisone|Induction - 60 mg/m^2 per day in 2-4 divided doses by mouth daily for 5 days; days 1, 2, 3, 4, 5.
16387847|NCT00043979|Drug|sirolimus|Initiated on day +3. Patients >40kg, the initial dose will be 2 mg every 24 hours orally. Patients <40 kg, the initial dose will be 1 mg/m^2.
16387987|NCT00042289|Drug|rifampicin|Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387848|NCT00043979|Drug|tacrolimus|Day -1 at least 24 hours before the stem cell infusion at a dose of 0.03 mg/kg/day as a continuous infusion. Twelve hours later oral dose initiated at a dose of 0.1-0.15 mg/kg/day in two divided doses every 12 hours.
16387849|NCT00043979|Drug|vincristine sulfate|Induction - 0.4 mg/m^2 per day continuous intravenous (IV) infusion over 24 hours daily for 4 days; 1, 2, 3, 4.
16387850|NCT00043979|Procedure|peripheral blood stem cell transplantation|Stem cells from a healthy donor are collected and transplanted into the patient using a central venous catheter.
16387851|NCT00043979|Drug|Filgrastim|
16387852|NCT00043979|Procedure|Peripheral Blood Stem Cell donation|
16387853|NCT00043940|Drug|bivalirudin|Bivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours.
16387854|NCT00043927|Drug|topotecan/cisplatin|
16387855|NCT00043927|Drug|etoposide/cisplatin|
16387856|NCT00043914|Drug|lamotrigine|
16387857|NCT00043901|Drug|lamotrigine|
16387858|NCT00043875|Drug|lamotrigine|
16387859|NCT00043862|Drug|topotecan|
16387860|NCT00043849|Drug|Quetiapine|
16387861|NCT00043836|Drug|ALT-711|
16387862|NCT00043823|Drug|Avastin|7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
16387863|NCT00043823|Drug|Tarceva|100 mg By Mouth Daily for 3 Weeks
16387864|NCT00043810|Procedure|Gelonin|Gelonin-AntiCD33 purging, 3 purging concentrations (fixed dose of 5 x 10^6 CD34+ cells/kg to be infused) with 3 dose levels of 1 nanomolar, 5.0 nanomolar and 10.0 nanomolar.
16387865|NCT00043810|Drug|Busulfan|130 mg/m2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -6 to -3).
16387866|NCT00043810|Drug|Fludarabine|40 mg/m2 in 100 ml of saline over one (1) hour on each of four (4) consecutive days (days - 6 to -3).
16387867|NCT00043797|Drug|Lidorestat (IDD 676)|
16387868|NCT00043784|Drug|enoxaparin|
16387869|NCT00043693|Behavioral|Family Intervention for Dual Diagnosis|The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.
16387870|NCT00043693|Behavioral|Family psychoeducation program|The family psychoeducation program consists of 6 weekly sessions.
16387871|NCT00043771|Drug|Tolvaptan|
16387872|NCT00043758|Drug|Tolvaptan|
16387873|NCT00043745|Dietary Supplement|Soy isoflavones|Soy isoflavones extracted from soy protein, compressed into tablets; three tablets taken daily
16387874|NCT00043745|Dietary Supplement|Extract tablets|Extract from soy protein, but devoid of isoflavones; three tablets taken once daily
16387875|NCT00043732|Drug|SCIO-469|
16387876|NCT00043719|Drug|Nitroglycerin ointment|
16387877|NCT00043719|Drug|Calcium supplement with vitamin D|
16387878|NCT00043706|Drug|Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody|
16387879|NCT00043602|Behavioral|Standard interpersonal psychotherapy (IPT)|Participants will receive 12 sessions of IPT over 12 weeks.
16387880|NCT00043602|Behavioral|Clinician managed interpersonal psychotherapy (CM-IPT)|Participants will receive 12 sessions of CM-IPT over 1 year.
16387881|NCT00043589|Drug|donepezil|
16387882|NCT00043589|Procedure|Memory-training class|
16387883|NCT00043576|Drug|calcitriol|
16387884|NCT00043576|Drug|docetaxel|
16387885|NCT00043680|Drug|Celecoxib|
16387886|NCT00043667|Drug|Daclizumab|
16387887|NCT00043654|Drug|Mifepristone|
16387888|NCT00043628|Procedure|Stem Cell Mobilization|
16387889|NCT00043563|Behavioral|Cognitive-Behavior Therapy|
16387890|NCT00043550|Behavioral|Supportive Expressive Therapy|The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
16387891|NCT00043550|Drug|Sertraline|Participants will receive sertraline.
16387892|NCT00043550|Drug|Pill Placebo|Participants will receive a pill placebo.
16387893|NCT00043550|Drug|Venlafaxine|Participants will receive venlafaxine.
16387894|NCT00043537|Behavioral|Social Effectiveness Therapy for Children (SET-C)|
16387895|NCT00043537|Drug|Fluoxetine|
16387896|NCT00043537|Drug|Pill Placebo|
16387897|NCT00043511|Biological|pGA2/JS2 Plasmid DNA Vaccine|
16387898|NCT00043459|Drug|intravenous T900607-sodium|
16387899|NCT00043446|Drug|intravenous T900607-sodium|
16387900|NCT00043433|Drug|intravenous T900607-sodium|
16387901|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387902|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387903|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387904|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387905|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387906|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387907|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387908|NCT00043420|Drug|PF-3512676|Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
16387988|NCT00042289|Drug|ethambutol|Women will receive ethambutol as prescribed by their clinicians. (Dosage will vary for each participant.)
16387989|NCT00042289|Drug|isoniazid|Women will receive isoniazid as prescribed by their clinicians. (Dosage will vary for each participant.)
16387909|NCT00043407|Drug|CPG 7909|In the phase I portion of the protocol, patients will be included in escalating dose groups: 0.08, 0.12, 0.16, 0.36, 0.54 or 0.81 mg/kg of CPG 7909 Injection. Patients will be treated once weekly subcutaneously for 24 weeks. In the Phase II portion of the trial patients will be treated at the MTD or the highest dose of 0.81 mg/kg identified in the Phase I dose escalation portion of the trial. All patients in Phase I and Phase II will be treated until disease progression or a maximum of 24 weeks.
16387910|NCT00043394|Drug|0.04 mg/kg CpG 7909|0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
16387911|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
16387912|NCT00043394|Drug|0.08 mg/kg CpG 7909|0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
16387913|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
16387914|NCT00043394|Drug|0.12 mg/kg CpG 7909|0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
16387915|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
16387916|NCT00043394|Drug|0.16 mg/kg CpG 7909|0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
16387917|NCT00043394|Drug|Herceptin®|Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
16387918|NCT00043381|Drug|decitabine (5-aza-2'deoxycytidine)|
16387919|NCT00043368|Drug|PF-3512676|PF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.
16387920|NCT00043355|Drug|interferon gamma-1b|500 mcg, oral, three times weekly
16387921|NCT00043342|Drug|interferon gamma-1b|100 or 200 mcg, SQ, 3x per week
16387922|NCT00043316|Drug|interferon gamma-1b|500 or 1000 mcg, inhalation, 3x per week
16387923|NCT00043303|Drug|interferon gamma-1b|100 or 200 mcg, SQ, 3x per week
16387924|NCT00043277|Drug|Angiomax (bivalirudin)|
16387925|NCT00043264|Drug|Rifampin|
16387926|NCT00043264|Drug|Azithromycin|
16387927|NCT00043212|Drug|Dendritic cell immunotherapy|
16387928|NCT00043199|Drug|Aroplatin (Liposomal NDDP, L-NDDP)|
16387929|NCT00043186|Drug|Placebo|Placebo subcutaneous injection
16387930|NCT00043186|Drug|Denosumab|Denosumab for subcutaneous injection
16387931|NCT00043186|Drug|Alendronate|Alendronate 70 mg tablets
16387932|NCT00042718|Drug|levofloxacin, azithromycin, amoxicillin/clavulanate|
16387933|NCT00042679|Drug|Gemcitabine|
16387934|NCT00042679|Drug|Carboplatin|
16387935|NCT00042679|Drug|LY900003|
16387936|NCT00042666|Drug|LY317615|500 mg, oral, QD, up to six 28 day cycles
16387937|NCT00042653|Drug|Placebo|30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
16387938|NCT00042653|Drug|AMG 073|30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally
16387939|NCT00042601|Drug|Pramlintide acetate|Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
16387940|NCT00042601|Drug|Placebo|placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper
16387941|NCT00042588|Drug|Recombinant Chimeric Monoclonal Antibody|
16387942|NCT00042575|Drug|Duloxetine|
16387943|NCT00042562|Drug|duloxetine|
16387944|NCT00042549|Device|Extracorporeal Shock Wave Lithotripsy|
16387945|NCT00042549|Drug|ursodiol|
16387946|NCT00042536|Drug|Naltrexone HCL/ Yohimbine HCL|
16387947|NCT00042510|Biological|Treatment group|
16387948|NCT00042497|Biological|autologous dexosomes loaded with tumor-specific peptides|
16387949|NCT00042484|Procedure|Community-level intervention & policy change|
16387950|NCT00042471|Drug|Pramlintide acetate|Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.
16387951|NCT00042458|Drug|Pramlintide acetate|Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
16387952|NCT00042458|Drug|Placebo|The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
16387953|NCT00042432|Drug|cinacalcet (AMG 073)|Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
16387954|NCT00042406|Drug|HuMax-CD4|
16387955|NCT00042393|Drug|Adefovir Dipivoxil|
16387956|NCT00042367|Drug|Induction therapy (Regimen 1, Course 1, Cycle A1|"2-8 hrs: Cisplatin 3.5 mg/kg + mannitol 0.4 g/kg in D5 NS (1000 ml/m2) over 6 hrs at approximately 167ml/m2/hr. 8-12 hrs: D5 NS (665 ml/m2) + KCl (2 mEq/100 ml) +MgSO4 (0.5 mEq/100 ml) at approximately 167ml/m2/hr.
~12-24 hrs: D5 NS + KCl (2 mEq/100 ml) + MgSO4 (0.5mEq/100 ml) at approximately 65 ml/m2/hr.
~Days 2,3: 0 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg of IVF over 15 min 15 min: Cyclophosphamide 30 mg/kg IV over 30 min 45 min: Post-chemotherapy hydration - D5 1/2 NS + KCl(1 mEq/100 ml) at approximately 130 ml/m2/hr for at least 24 hours.
~3 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 6 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 9 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 12 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min Day 4 G-CSF 5 µg/kg subcutaneously, daily until ANC ≥ 2000 on two consecutive days, post ANC nadir.
~Day 8: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Day 15: Vincristine 0.05 mg/kg IV push (max dose = 2 mg)"
16387957|NCT00042367|Drug|Regimen 1, Course 1, Cycle A2 (Days 22 - 42)|Drugs and doses are same as in Cycle A1. Cycle A2 begins following recovery from Cycle A1, but no sooner than day 21. Patients with delays in recovery beyond day 28 should have dose modifications
16388039|NCT00041977|Drug|doxycycline hyclate 20 mg twice daily|
16388040|NCT00041938|Drug|aspirin|325 mg per day
16387958|NCT00042367|Drug|Cycle B|"Days 43 - 63) Etoposide, 1.7 mg/kg p.o. qd x 21 days. The dose will be diluted immediately prior to administration in juice flavored syrup to a final concentration of 0.4 Each dose should be aken 1 hour before or 2 hours after a meal.
~Cycle B begins following recovery from Cycle A2; however, it begin no sooner than 21 days after the start of Cycle A2.
~Monitor weekly CBC/diff/plt. If ANC < 500/mm3 or platelets (unsupported) < 50,000/mm3 then discontinue etoposide. A 25% reduction should be made for the next cycle of oral etoposide.
~Interim Response Evaluation (Days 64 - 70) Interim Response Evaluation should be performed the week following the completion of Course 1."
16387959|NCT00042367|Drug|Regimen 1, Course 2|6.3.3 Regimen 1, Course 2 Repeat systemic therapy as per Course 1 (Cycle A1, Cycle A2, and Cycle B) in patients with SD or better at the interim response evaluation (see Figure 2 for IT mafosfamide guidelines). Course 2 should not begin any sooner than 7 days after the completion of Course 1.
16387960|NCT00042367|Drug|Intrathecal Mafosfamide|Regimen 1, Course 1 Mafosfamide, 14 mg, is given two times/week during Cycle A1 and Cycle A2 of Course 1, for 12 total doses during days 1-41. The first dose of Cycles A1 and A2 should be given, if possible, on the same day as the first I.V. cyclophosphamide dose and the second dose 3 to 4 days later. The assigned dose is given one time/week during Cycle B, Course 1 for 3 total doses during days 43 - 63.
16387961|NCT00042367|Drug|Regimen 1 Course 2, IT mafosfamide|"Regimen 1, Course 2 The assigned dose is administered once with IV cyclophosphamide during each of Cycle A1 and Cycle A2, and day 1 of Cycle B for a total of 3 doses during Course 2.
~Patients with an initially abnormal flow study, who show no evidence of obstructive hydrocephalus or compartmentalization on the repeat study, may begin intrathecal mafosfamide administration with the initiation of Regimen 1, Course 2. The frequency of intrathecal mafosfamide administration, for such patients, will be as outlined in Regimen 1, Course
~1."
16387962|NCT00042367|Drug|Regimen 2, Course 1|"Cycle C1 (Days 1 - 21) Day 1: Prehydrate with D5W 1/2 NS + KCl 2 mEq/100 ml) at 2 times the hourly maintenance rate until the urine specific gravity is < 1.012.
~0 hrs: Mesna 6 mg/kg IV over 15 min. Dilute in 0.65 ml/kg IVF. 15 min: Vincristine 0.05 mg/kg IV push (Day 1 only)(max dose = 2 mg) 20 min: Cyclophosphamide 30 mg/kg IV over 30 min. 50 min: Post-chemotherapy hydration - D5 1/2 NS + KCl
~(1 mEq/100 ml) at twice the hourly maintenance rate for at least 24 hours. 3 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 6 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 9 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min 12 hrs: Mesna 6 mg/kg IV in 0.65 ml/kg IVF over 15 min Day 2: Repeat day 1, but omit vincristine. Day 3: G-CSF 5 µg/kg/day subcutaneously, daily, until ANC is > 2000 on two consecutive days, post ANC nadir."
16387963|NCT00042367|Drug|Regimen 2, Course, 1, Cycle C1|"Cycle C1, Weeks 2 and 3 Day 8: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Day 15: Vincristine 0.05 mg/kg IV push (max dose = 2 mg) Cycle C2 (Days 22-42) Drugs and doses are same as in Cycle C1. Cycle C2 begins following recovery from Cycle C1, but no sooner than day 21. Patients with delays in recovery beyond day 28 should have dose modificationsCycle D (Days 43 - 63) Etoposide 1.7 mg/kg, po qd x 21 days The dose will be diluted immediately prior to administration in juice or flavored syrup as per section 3.4.3. Each dose should be taken 1 hour before or 2 hours after a meal.
~Cycle D should begin following recovery from Cycle C2; however, it should begin no sooner than 21 days after the start of Cycle C2."
16387964|NCT00042367|Drug|Regimen 2, Course 2|Repeat Course 1 (Cycle C1, Cycle C2, and Cycle D) in patients with SD or better at the interim response evaluation. Chemotherapy should begin as soon as the patient has recovered from the toxicities of oral etoposide in cycle D, course 1. However, it should not begin any sooner than 7 days after the completion of Course 1.
16387965|NCT00042367|Radiation|radiation therapy|"Conformal Irradiation Patients who are initially M0 with a CR, PR, or SD to Regimen 1 induction chemotherapy (with or without second surgery) will receive local irradiation using conformal techniques. Treatment will commence within 2 weeks of completing Regimen 1 or second surgery. Treatment planning and technique may involve 3D conformal,IMRT, or proton planning and delivery, provided the guidelines regarding volume, dose,and normal tissue restrictions are honored.
~8.3.1 Fraction Size 180 cGy fractions will be used for all target volumes. 8.3.2 Fractionation Conventional fractionation will be used. Treatments will be given once daily, 5 days/week except for necessary interruptions secondary to medical or administrative reasons."
16387966|NCT00042354|Drug|clofarabine (IV formulation)|
16387967|NCT00042341|Drug|clofarabine (IV formulation)|
16387968|NCT00042328|Drug|Valacyclovir|
16387969|NCT00042315|Procedure|Chemotherapy|
16387970|NCT00042315|Drug|tariquidar + vinorelbine|
16387971|NCT00042315|Drug|placebo + vinorelbine|
16387972|NCT00042302|Procedure|Chemotherapy|
16387973|NCT00042302|Drug|tariquidar + paclitaxel/carboplatin|
16387974|NCT00042302|Drug|placebo + paclitaxel/carboplatin|
16387975|NCT00042289|Drug|atazanavir/cobicistat|Women will receive atazanavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
16387976|NCT00042289|Drug|darunavir/ritonavir|Women will receive darunavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
16387977|NCT00042289|Drug|darunavir/cobicistat|Women will receive darunavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
16387978|NCT00042289|Drug|etravirine|Women will receive etravirine as prescribed by their clinicians. (Dosage will vary for each participant.)
16387979|NCT00042289|Drug|elvitegravir/cobicistat|Women will receive elvitegravir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
16387980|NCT00042289|Drug|dolutegravir|Women will receive dolutegravir as prescribed by their clinicians. (Dosage will vary for each participant.)
16387981|NCT00042289|Drug|tenofovir alafenamide fumarate (TAF)|Women will receive TAF as prescribed by their clinicians. (Dosage will vary for each participant.)
16387982|NCT00042289|Drug|TAF/cobicistat|Women will receive TAF/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)
16387983|NCT00042289|Drug|TAF/ritonavir|Women will receive TAF/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
16387984|NCT00042289|Drug|efavirenz|Women will receive efavirenz as prescribed by their clinicians. (Dosage will vary for each participant.)
16387985|NCT00042289|Drug|lopinavir/ritonavir|Women will receive lopinavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)
16387986|NCT00042289|Drug|nevirapine|Women will receive nevirapine as prescribed by their clinicians. (Dosage will vary for each participant.)
16388041|NCT00041938|Drug|Warfarin|INR 2.5-3.0; target INR 2.75
16387990|NCT00042289|Drug|pyrazinamide|Women will receive pyrazinamide as prescribed by their clinicians. (Dosage will vary for each participant.)
16387991|NCT00042289|Drug|rifampicin|Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387992|NCT00042289|Drug|kanamycin|Women will receive kanamycin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387993|NCT00042289|Drug|amikacin|Women will receive amikacin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387994|NCT00042289|Drug|capreomycin|Women will receive capreomycin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387995|NCT00042289|Drug|moxifloxacin|Women will receive moxifloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387996|NCT00042289|Drug|levofloxacin|Women will receive levofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387997|NCT00042289|Drug|ofloxacin|Women will receive ofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)
16387998|NCT00042289|Drug|ethionamide/prothionamide|Women will receive ethionamide/prothionamide as prescribed by their clinicians. (Dosage will vary for each participant.)
16387999|NCT00042289|Drug|terizidone/cycloserine|Women will receive terizidone/cycloserine as prescribed by their clinicians. (Dosage will vary for each participant.)
16388000|NCT00042289|Drug|para-aminosalicylic acid (PAS)|Women will receive PAS as prescribed by their clinicians. (Dosage will vary for each participant.)
16388001|NCT00042289|Drug|high dose isoniazid (INH)|Women will receive high dose INH as prescribed by their clinicians. (Dosage will vary for each participant.)
16388002|NCT00042289|Drug|bedaquiline|Women will receive bedaquiline as prescribed by their clinicians. (Dosage will vary for each participant.)
16388003|NCT00042289|Drug|clofazamine|Women will receive clofazamine as prescribed by their clinicians. (Dosage will vary for each participant.)
16388004|NCT00042289|Drug|delamanid|Women will receive delamanid as prescribed by their clinicians. (Dosage will vary for each participant.)
16388005|NCT00042289|Drug|linezolid|Women will receive linezolid as prescribed by their clinicians. (Dosage will vary for each participant.)
16388006|NCT00042289|Drug|pretomanid|Women will receive pretomanid as prescribed by their clinicians. (Dosage will vary for each participant.)
16388007|NCT00042289|Drug|atazanavir/ritonavir/tenofovir|Women will receive atazanavir/ritonavir/tenofovir as prescribed by their clinicians. (Dosage will vary for each participant.)
16388008|NCT00042289|Drug|ethinyl estradiol oral contraceptive|Women will receive ethinyl estradiol oral contraceptive as prescribed by their clinicians. (Dosage will vary for each participant.)
16388009|NCT00042289|Drug|etonogestrel implant|Women will receive etonogestrel implant as prescribed by their clinicians. (Dosage will vary for each participant.)
16388010|NCT00041483|Drug|Anecortave Acetate 15 mg sterile suspension|
16388011|NCT00041483|Other|Photodynamic Therapy (PDT)|
16388012|NCT00042380|Drug|Novasoy|
16388013|NCT00042250|Drug|Chemotherapy for hematologic malignancy|
16388014|NCT00042237|Behavioral|Schema Therapy|
16388015|NCT00042224|Procedure|Electroconvulsive Therapy (ECT)|ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
16388016|NCT00042224|Drug|Clozapine|Patients with psychotic symptoms will receive clozapine
16388017|NCT00042211|Behavioral|Problem Solving Treatment|Brief Cognitive Behavioral Therapy
16388018|NCT00042211|Behavioral|Control|No treatment control
16388019|NCT00042198|Behavioral|Cognitive behavior therapy|Up to 12 weekly, individual, hour-long sessions
16388020|NCT00042198|Behavioral|Supportive Stress Management|Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
16388021|NCT00042185|Behavioral|Dissonance Eating Disorder Prevention Program|In this intervention, participants voluntarily engaged in verbal, written, and behavioral exercises in which they critiqued the thin-ideal ideal. These exercises were conducted in sessions and in homework activities. For example, they wrote a counter-attitudinal essay about the costs associated with pursuit of the thin-ideal and engaged in a counter-attitudinal role-play in which they attempted to dissuade facilitators from pursuing the thin-ideal.
16388022|NCT00042185|Behavioral|Healthy Weight Intervention|In this intervention, participants were encouraged to make gradual healthy and lasting changes to their diet and physical activity to balance their energy needs with their energy intake, and thereby achieve a healthier weight and body satisfaction. With support from the facilitator and group members, they initiated an individual lifestyle change plan to reduce intake of fat and sugar and to increase exercise using behavioral modification principles. Food and exercise diaries were used to identify behaviors to target in this lifestyle modification and to monitor change. Motivational enhancement activities were used to promote motivation for behavior change.
16388023|NCT00042185|Behavioral|Expressive Writing Control Condition|In this condition, which is based on the work of Pennebaker (1997), participants wrote about emotionally significant topics in three individual weekly 45-minute sessions. They were told that research indicates that body dissatisfaction is linked to emotional issues and that expressive writing helps resolve these issues. Sample topics included relationships or goals. They were told that their work would not be read and were asked to write continuously for the duration of the session about an emotionally important topic.
16388024|NCT00042172|Drug|Donepezil|
16388025|NCT00042172|Drug|Ginkgo Biloba Extract|
16388026|NCT00042159|Device|repetitive transcranial magnetic stimulation|1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets
16388027|NCT00042146|Behavioral|Cognitive-behavior therapy|
16388028|NCT00042146|Drug|zolpidem|
16388029|NCT00042094|Biological|Cell-Cultured Smallpox Vaccine compared to Dryvax®|
16388030|NCT00042081|Drug|CGT003 (E2F Duplex Decoy)|
16388031|NCT00042068|Drug|Meloxicam|
16388032|NCT00042055|Drug|CP-461|
16388033|NCT00042042|Behavioral|Family based educational program|
16388034|NCT00042029|Drug|MK0869, aprepitant|
16388035|NCT00042029|Drug|Comparator: placebo|
16388036|NCT00042016|Drug|decitabine (5-aza-2'deoxycytidine)|
16388037|NCT00042003|Drug|decitabine (5-aza-2'deoxycytidine)|
16388038|NCT00041990|Drug|decitabine (5-aza-2'deoxycytidine)|
16388043|NCT00041860|Procedure|Controlled Exposure to Environmental Contaminant|
16388044|NCT00041821|Procedure|Nasal irritation thresholds and irritant provocation|
16388045|NCT00041899|Drug|CDB-2914|
16388046|NCT00041899|Drug|COB-2914|
16388047|NCT00041808|Drug|MTC-DOX for Injection|
16388048|NCT00041808|Procedure|Chemotherapy|
16388049|NCT00041795|Drug|leteprinim potassium (Neotrofin)|
16388050|NCT00041782|Drug|Dalteparin (Fragmin)|200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU).
16388051|NCT00041769|Procedure|Therapeutic Drug Monitoring (TDM)|
16388052|NCT00041756|Drug|PG-530742|One 25 mg PG-530742 tablet, twice daily for for one year
16388053|NCT00041756|Drug|Placebo|One placebo tablet, twice daily for for one year
16388054|NCT00041756|Drug|50 mg PG-530742|One 50 mg PG-530742 tablet, twice daily for for one year
16388055|NCT00041756|Drug|100 mg PG-530742|100 mg PG-530742 tablet, twice a day for one year
16388056|NCT00041756|Drug|200 mg PG-530742|200 mg PG-530742 tablet, twice a day for one year
16388057|NCT00041743|Behavioral|Group Cognitive Behavioral Therapy|
16388058|NCT00041730|Biological|Id-KLH|
16388059|NCT00041717|Drug|Fampridine-SR|25mg bid (twice daily)
16388060|NCT00041717|Other|Placebo|Placebo
16388061|NCT00041704|Drug|Anidulafungin, VER002|
16388062|NCT00041691|Drug|hMN14 (labetuzumab)|
16388063|NCT00041678|Drug|aripiprazole|
16388064|NCT00041665|Drug|Recombinant Human Keratinocyte Growth Factor|
16388065|NCT00041652|Drug|hMN14 (labetuzumab)|
16388066|NCT00041639|Drug|hMN14 (labetuzumab)|
16388067|NCT00041626|Genetic|INGN 201|
16388068|NCT00041613|Genetic|INGN 201|
16388069|NCT00041587|Drug|IL13-PE38QQR|
16388070|NCT00041587|Procedure|targeted fusion protein therapy|
16388071|NCT00041587|Procedure|surgery|
16388072|NCT00041509|Drug|SB-424323|500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
16388073|NCT00041509|Drug|Placebo|matching placebo, oral, BID for 28 days
16388074|NCT00041496|Drug|SB-207266|White, oval, biconvex tablets containing either 10mg, 25mg or 40mg
16388075|NCT00041496|Other|Placebo|Placebo to match SB-207266
16388076|NCT00041574|Drug|Inhaled Nitric Oxide|Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
16388077|NCT00041561|Drug|Nitrogen gas|Nitrogen gas will be given at 5ppm until Day 28 or extubation
16388078|NCT00041561|Drug|inhaled nitric oxide|inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
16388079|NCT00041548|Drug|nitric oxide for inhalation|given at 20 ppm for 1 hour then weaned off over 4 hours
16388080|NCT00041548|Drug|Oxygen|given at 20 ppm for one hour, then weaned off over four hours
16388081|NCT00041535|Drug|OGT 918|
16388082|NCT00041470|Drug|Paclitaxel|50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
16388083|NCT00041470|Drug|Vinorelbine|20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
16388084|NCT00041470|Drug|Herceptin|4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
16388085|NCT00041470|Drug|Filgrastim|5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
16388086|NCT00040677|Drug|Low Dose ICA-17043|Low dose arm
16388087|NCT00040677|Drug|High dose ICA-17043|150 mg Loading Dose; 10 mg daily dose
16388088|NCT00040677|Drug|Placebo|Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group
16388089|NCT00040664|Drug|ritonavir|ritonavir oral capsules or oral solution
16388090|NCT00040664|Drug|fosamprenavir|fosamprenavir oral suspension or tablet
16388091|NCT00040651|Drug|Fludarabine|
16388092|NCT00040651|Drug|Cyclophosphamide|
16388093|NCT00040651|Drug|Thymoglobulin|
16388094|NCT00040651|Procedure|Leukapheresis|
16388095|NCT00040651|Procedure|Self bone marrow transplant|
16388096|NCT00041431|Drug|Hormone Replacement Therapy|
16388097|NCT00041392|Drug|Magnesium|100 mg/kg
16388098|NCT00041392|Drug|0.9% saline|Placebo
16388099|NCT00040638|Drug|TLK286|
16388100|NCT00040625|Drug|Pemetrexed|
16388101|NCT00040625|Drug|Cisplatin|
16388102|NCT00040027|Drug|thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a|
16388103|NCT00040027|Drug|placebo + PEGinterferon alfa-2a|
16388104|NCT00040599|Drug|hMN14 (labetuzumab)|
16388105|NCT00040586|Drug|Monoclonal Antibody J591|
16388106|NCT00040586|Drug|Recombinant Interleukin-2|
16388107|NCT00040573|Drug|131I-TM-601|
16388108|NCT00040560|Drug|111In-DAC|
16388109|NCT00040560|Procedure|Diagnostic|
16388110|NCT00040547|Drug|Farnesyl Protein Transferase Inhibitor|
16388111|NCT00040534|Drug|Farnesyl Protein Transferase Inhibitor|
16388112|NCT00040521|Drug|Recombinant Human Interleukin-11 (rhIL-11)|
16388113|NCT00040495|Drug|Pantoprazole|
16388114|NCT00040482|Drug|Cyclophosphamide|
16388115|NCT00040482|Drug|ATG|
16388116|NCT00040482|Drug|MESNA|
16388117|NCT00040482|Procedure|Radiation therapy|
16388118|NCT00040469|Drug|Campath -1H|
16388119|NCT00040469|Drug|Dilantin|
16388120|NCT00040469|Drug|Busulfan|
16388121|NCT00040469|Drug|Cyclophosphamide|
16388197|NCT00039741|Drug|NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)|Accepted NRTIs: abacavir sulfate (ABC), emtricitabine (FTC), emtricitabine/Tenofovir disoproxil fumarate (FTC/TDF), lamivudine (3TC), lamivudine/zidovudine (3TC/AZT), stavudine (d4T), tenofovir disoproxil fumarate (TDF), zalcitabine (ddC), zidovudine (AZT) Prescribed per participant's doctor
16388920|NCT00029393|Drug|Immunosuppression|
16388122|NCT00040456|Drug|Mg Pidolate|Mag 2 will be used (magnesium pidolate, a granular powder, containing 0.184 g of Mg/packet, equal to 7.6 mmol or 15.2 meq Mg), since this preparation has less side effects such as diarrhea than other Mg preparations. The study medication will be a liquid containing 0.6 meq Mg pidolate/kg body weight per day, divided into 2 daily doses. The Mg pidolate (45 g) will be distributed as a pre-mixed powder containing Koolaid Tropical Punch powder (9 gm), and sucrose (67 gm).
16388123|NCT00040456|Drug|Placebo|The study medication will be a liquid containing an equivalent amount of placebo to the study medication, divided into 2 daily doses.The placebo will have the same amount of sucrose and Tropical Punch powder as the study drug, MG Pidolate, as well as 45 g of lactose. Subjects will continue with the same assignment for 6 months and then switch to the other arm (after a 2-month wash-out period).
16388124|NCT00040443|Drug|CX516|
16388125|NCT00040443|Drug|Placebo|
16388126|NCT00040430|Drug|111In-DAC|
16388127|NCT00040430|Procedure|Diagnostic|
16388128|NCT00040508|Drug|Sirolimus|
16388129|NCT00040417|Drug|FLUDARABINE|
16388130|NCT00040417|Drug|CAMPATH-IH|
16388131|NCT00040417|Procedure|Total Body Irradiation|
16388132|NCT00040417|Drug|FK506|
16388133|NCT00040417|Drug|G-SCF (Granulocyte-colony stimulating factor)|
16388134|NCT00040404|Drug|CEP-1347 10mg|CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
16388135|NCT00040404|Drug|CEP1347 25mg|CEP1347 25mg, a K252a derivative, retains neuroprotective properties
16388136|NCT00040404|Drug|CEP-1347 50mg|CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
16388137|NCT00040404|Other|Placebo Comparator|Placebo capsules matching the CEP-1347 capsules
16388138|NCT00040391|Drug|Investigational drug|
16388139|NCT00040391|Drug|Irinotecan|
16388140|NCT00040391|Drug|5-fluorouracil|
16388141|NCT00040391|Drug|Leucovorin|
16388142|NCT00040378|Drug|alphatocopherol|400 IU daily
16388143|NCT00040378|Drug|Selenium|200mcg daily
16388144|NCT00040378|Drug|Placebo replacement for vitamin E|1 placebo pill daily
16388145|NCT00040378|Drug|Placebo replacement for Selenium|1 placebo pill daily
16388146|NCT00040365|Drug|Amifostine trihydrate|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
16388147|NCT00040365|Radiation|Radiation therapy|The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy.
16388148|NCT00040339|Procedure|hypothermia (body temperature lowered to 33°C or 91.4°F)|
16388149|NCT00040326|Procedure|anteromesial temporal resection|surgical treatment for epilepsy
16388150|NCT00040326|Drug|antiepileptic drugs|pharmacotherapy
16388151|NCT00040313|Drug|pegaptanib sodium (Macugen)|
16388152|NCT00040300|Drug|Racivir|
16388153|NCT00040287|Behavioral|smoking cessation program|
16388154|NCT00040287|Behavioral|weight control program|
16388155|NCT00040274|Drug|DPC 817|
16388156|NCT00040183|Drug|Tarceva (erlotinib HCl, OSI-774)|
16388157|NCT00040170|Biological|MVA-MUC1-IL2|
16388158|NCT00040157|Drug|ACH126-443 (Beta-L-Fd4C)|
16388159|NCT00040144|Drug|ACH126, 433|
16388160|NCT00040261|Drug|Memantine HCL|
16388161|NCT00040248|Drug|Daclizumab|
16388162|NCT00040235|Procedure|magnesium|
16388163|NCT00040209|Drug|JP 1730|
16388164|NCT00040209|Drug|IV Levodopa|
16388165|NCT00040209|Drug|IV Apomorphine|
16388166|NCT00040131|Drug|IL-10|
16388167|NCT00040105|Drug|Zarnestra (R115777)|"Starting Dose:
~300 mg by mouth (PO) Twice daily"
16388168|NCT00040105|Drug|Gleevec (Imatinib mesylate)|"Starting Dose:
~300 mg By Mouth (PO) daily"
16388169|NCT00040092|Drug|Virulizin®|
16388170|NCT00040014|Drug|exemestane|
16388171|NCT00040001|Drug|DTI-0009|
16388172|NCT00039988|Drug|Glatiramer acetate|20 mg administered subcutaneously daily
16388173|NCT00039988|Drug|Albuterol|2 mg or 4 mg oral capsules taken daily
16388174|NCT00039988|Drug|Albuterol placebo|Oral placebo capsules will be taken daily
16388175|NCT00039975|Drug|Indinavir sulfate|
16388176|NCT00039975|Drug|Ritonavir|
16388177|NCT00039975|Drug|Amlodipine|
16388178|NCT00039975|Drug|Diltiazem HCl|
16388179|NCT00039962|Drug|thymalfasin (thymosin alpha 1)|
16388180|NCT00039962|Drug|PEGinterferon alfa-2a|
16388181|NCT00039936|Behavioral|Cognitive Behavior Treatment|
16388182|NCT00039936|Behavioral|Self Help|
16388183|NCT00039936|Behavioral|Partial Self Help|
16388184|NCT00040066|Procedure|Cocaine (IV)|
16388185|NCT00040053|Drug|Ondansetron|
16388186|NCT00040040|Drug|Bupropion|
16388187|NCT00039910|Drug|(PN-152,243)/ PN-196,444|
16388188|NCT00039884|Drug|NESP - Novel Erythropoiesis Stimulating Protein|
16388189|NCT00039871|Biological|PegIntron (peginterferon alfa-2b; SCH 54031)|PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
16388190|NCT00039871|Drug|REBETOL (ribavirin; SCH 18908)|REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
16388191|NCT00039858|Drug|Argatroban|
16388192|NCT00039832|Drug|Abciximab (ReoPro) and Reteplase (Retavase)|
16388193|NCT00039793|Procedure|Moderate-intensity and low-intensity bodywork therapy|
16388194|NCT00039780|Drug|BNP7787|The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
16388195|NCT00039780|Drug|Placebo|The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
16388196|NCT00039754|Drug|Holmium-166-DOTMP|
16388260|NCT00038649|Drug|Gleevec|400 mg orally twice daily
16388198|NCT00039741|Drug|NNRTIs (EFV, NVP)|"Accepted NNRTIs: efavirenz (EFV), nevirapine (NVP)
~Prescribed per participant's doctor"
16388199|NCT00039741|Drug|PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)|"Accepted PIs: amprenavir (APV). indinavir sulfate (IDV), lopinavir/ritonavir (LPV/r), nelfinavir mesylate (NFV), saquinavir (SQV), ritonavir (RTV)
~Prescribed per participant's doctor"
16388200|NCT00039767|Drug|Lepirudin|
16388201|NCT00039026|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388202|NCT00039026|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388203|NCT00039026|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388204|NCT00039026|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
16388205|NCT00039013|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388206|NCT00039013|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
16388207|NCT00039013|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388208|NCT00039013|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
16388209|NCT00039000|Drug|HSPPC-96 or Oncophage|
16388210|NCT00038987|Biological|Wetvax (APSV)|
16388211|NCT00038974|Drug|peginterferon alfa-2a|
16388212|NCT00038974|Drug|Ribavirin|
16388213|NCT00038961|Drug|fondaparinux sodium|2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
16388214|NCT00038961|Other|placebo|placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
16388215|NCT00039702|Drug|[123] 5-I-A-85380|
16388216|NCT00039663|Drug|Pravastatin|
16388217|NCT00039663|Drug|Gemfibrozil|
16388218|NCT00039663|Drug|Rosiglitazone|
16388219|NCT00039624|Radiation|Brachytherapy|Patients will receive two HDR brachytherapy implants (950-1050 cGy/implant) before and at the end of a course of external beam radiotherapy (4600 cGy, 2Gy/day).
16388220|NCT00038948|Drug|Sirolimus|Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
16388221|NCT00038948|Drug|tacrolimus|
16388222|NCT00038948|Drug|Cyclosporine A|
16388223|NCT00038935|Drug|ReFacto AF|
16388224|NCT00038922|Drug|rhIL-11|
16388225|NCT00038909|Drug|BDDrFVII|
16388226|NCT00038896|Drug|Venlafaxine ER|
16388227|NCT00038883|Drug|Campath-1H|10 mg/day x 5, starting with the first day of chemotherapy
16388228|NCT00038870|Biological|Dendritic Cell Activated Lymphocyte|
16388229|NCT00038857|Procedure|Megadose of CD34 Selected Progenitor Cells|Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0.
16388230|NCT00038857|Drug|Melphalan|140 mg/m^2 on day -8
16388231|NCT00038857|Drug|Thiotepa|10 mg/kg on day -7
16388232|NCT00038857|Drug|Fludarabine|160 mg/m^2 over 4 days on days -6, -5, -4, -3
16388233|NCT00038857|Drug|Rabbit ATG|1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
16388234|NCT00038844|Drug|Campath-1 H (Alemtuzumab)|Starting Dose of 15 mg by vein daily, 3 days in a row.
16388235|NCT00038844|Drug|Fludarabine|30 mg/m2 by vein daily, 3 days in a row.
16388236|NCT00038844|Drug|Cyclophosphamide|1 gm/m2 by vein daily, 3 days in a row.
16388237|NCT00038844|Drug|Rituximab|375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
16388238|NCT00038831|Drug|Mylotarg|Starting dose 2 mg/m^2 over 2-hour intravenous infusion on day -12.
16388239|NCT00038831|Drug|Fludarabine|30 mg/m^2 will be given intravenously daily at the same time over 30 minutes on days -5, -4, -3, -2.
16388240|NCT00038831|Drug|Melphalan|140 mg/m^2 will be given intravenously over 20 minutes starting 2 hours after the beginning of the fludarabine infusion on day -2.
16388241|NCT00038831|Drug|Anti-thymocyte globulin|Patients with an unrelated or mismatched related donor will receive 0.5 mg/kg on day -3 and 1.25 mg/Kg on days -2 and -1, following the chemotherapy.
16388242|NCT00038831|Procedure|Stem cell transplant|Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation: Infusion of blood stem cells or bone marrow cells on day 0.
16388243|NCT00038818|Biological|CD8 Depleted Donor Lymphocyte|
16388244|NCT00038805|Drug|Mylotarg|
16388245|NCT00038792|Drug|Recombinant Human Keratinocyte Growth Factor|
16388246|NCT00038779|Procedure|Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation|
16388247|NCT00038766|Drug|semapimod|semapipmod 60 mg IV x 5 days
16388248|NCT00038766|Drug|semapimod|IV 30 mg x 5 days
16388249|NCT00038766|Drug|placebo|placebo IV
16388250|NCT00038753|Procedure|Vision Screening|
16388251|NCT00038727|Behavioral|DPPOS Group Lifestyle|Quarterly group lifestyle sessions
16388252|NCT00038727|Drug|Metformin|Administered as 850mg twice per day, masked in DPP and open label in DPPOS
16388253|NCT00038727|Behavioral|DPPOS Boost Lifestyle|In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
16388254|NCT00038727|Behavioral|Intensive Lifestyle Group Session|16 session curriculum in group format. In DPP delivered to ILS as individual sessions
16388255|NCT00038714|Drug|SGN-00101|
16388256|NCT00038701|Drug|TNP-470|
16388257|NCT00038688|Behavioral|Peer HIV Education Program|
16388258|NCT00038675|Drug|Imatinib Mesylate (Gleevec)|Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily
16388259|NCT00038662|Drug|Atrasentan|
16388261|NCT00038636|Drug|Lopinavir/ritonavir|
16388262|NCT00038636|Drug|Ritonavir|
16388263|NCT00038623|Drug|Yttrium-ibritumomab (Zevalin)|After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
16388264|NCT00038623|Drug|Rituximab|250 mg/m^2 in the vein over 6 to 8 hours on Day 1.
16388265|NCT00038610|Drug|Imatinib Mesylate|600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8.
16388266|NCT00038610|Drug|Cyclophosphamide|300 mg/m^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m^2) for courses 1, 3, 5, 7.
16388267|NCT00038610|Drug|Doxorubicin|50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.
16388268|NCT00038610|Drug|Vincristine|2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.
16388269|NCT00038610|Drug|Dexamethasone|40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.
16388270|NCT00038610|Drug|Methotrexate|"12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7.
~200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours on day 1 of courses 2, 4, 6, 8."
16388271|NCT00038610|Drug|Cytarabine|"100 mg intrathecally day 7 for courses 1, 3, 5, 7.
~3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8."
16388272|NCT00038610|Drug|Mesna|600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7.
16388273|NCT00038610|Drug|G-CSF|10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
16388274|NCT00038597|Drug|SCH66336|
16388275|NCT00038584|Drug|SCH66336|
16388276|NCT00038571|Drug|PS341 (Bortezomib)|1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.
16388277|NCT00038558|Drug|Filgrastim SD/01|
16388278|NCT00038558|Drug|Adriamycin|
16388279|NCT00038558|Drug|Bleomycin|
16388280|NCT00038558|Drug|Vinblastine|
16388281|NCT00038558|Drug|DTIC|
16388282|NCT00038545|Drug|Filgrastim SD/01|
16388283|NCT00038545|Drug|Paclitaxel|
16388284|NCT00038545|Drug|Topotecan|
16388285|NCT00038532|Drug|Amprenavir/ritonavir|
16388286|NCT00038532|Drug|Saquinavir/ritonavir|
16388287|NCT00038532|Drug|Efavirenz|
16388288|NCT00038519|Drug|Amprenavir/ritonavir|
16388289|NCT00038519|Drug|Saquinavir/ritonavir|
16388290|NCT00038506|Drug|abacavir/lamivudine/zidovudine|
16388291|NCT00038506|Drug|tenofovir|
16388292|NCT00038493|Drug|Temozolomide and SCH66336|
16388293|NCT00038480|Drug|Lopinavir/Ritonavir|
16388294|NCT00038467|Drug|Tamoxifen|Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
16388295|NCT00038467|Drug|Exemestane|Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
16388296|NCT00038454|Drug|Hemolink (hemoglobin raffimer IV solution)|
16388297|NCT00038441|Drug|DTI-015|DTI-015 injected through a catheter into center of brain tumor.
16388298|NCT00038428|Drug|TLK286|
16388299|NCT00038415|Biological|CLL vaccine using DNA plasmid vector|
16388300|NCT00038402|Drug|Herceptin|Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.
16388301|NCT00038402|Drug|Taxol|225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.
16388302|NCT00038402|Drug|Fluorouracil|500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.
16388303|NCT00038402|Drug|Cytoxan|500 mg/m^2 on Day 1 of each cycle for 4 cycles.
16388304|NCT00038402|Drug|Epirubicin|75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.
16388305|NCT00038389|Drug|Vioxx|Starting dose for patients age 3-14 years 10.0 mg/1.73 m2 and for patients above 14 years of age 12.5 mg for 5 days per week for 6 weeks during radiation treatment, and 7 days per week for 6 months after radiation treatment.
16388306|NCT00038376|Drug|Isotretinoin (Accutane)|0.5 mg/k (1.0 mg/k total) by mouth twice a day
16388307|NCT00038376|Drug|Interferon Alpha|Starting dose of 3 MU injected under skin once a day for 12 weeks.
16388308|NCT00038363|Procedure|Rehabilitation|
16388309|NCT00038363|Procedure|Subacute care|
16388310|NCT00038350|Behavioral|Lingual Strengthening|8 week lingual strengthening exercise protocol
16388311|NCT00038337|Procedure|Health Literacy|
16388312|NCT00038311|Drug|PN-152,243)/PN-196,444|
16388313|NCT00038298|Drug|Placebo|Placebo given 3 times weekly
16388314|NCT00038298|Drug|AMG 719|50 mg 3 times weekly
16388315|NCT00038298|Drug|AGM 719|200 mg 3 times weekly
16388316|NCT00038298|Drug|AMG 719|400 mg 3 times weekly
16388317|NCT00038298|Drug|placebo to AMG 719|Placebo dose given 3 times weekly
16388318|NCT00038285|Procedure|Amputation Prevention|
16388319|NCT00038272|Drug|Mycophenolate mofetil|
16388320|NCT00038272|Drug|Amdoxovir|
16388321|NCT00038259|Drug|Aldesleukin|
16388322|NCT00038246|Drug|Estramustine|140 mg by mouth (po) three times a day on Days 1-5, 8-12
16388323|NCT00038246|Drug|Thalidomide|200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity.
16388324|NCT00038246|Drug|Paclitaxel (Taxol)|100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10
16388325|NCT00038233|Drug|Thalidomide|200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)
16388326|NCT00038220|Drug|Lopinavir/ritonavir|
16388327|NCT00038220|Drug|Efavirenz|
16388328|NCT00038220|Drug|Lamivudine|
16388329|NCT00038220|Drug|Tenofovir DF|
16388330|NCT00038207|Drug|Liposomal Vincristine|Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
16388331|NCT00038194|Drug|imatinib mesylate|
16388332|NCT00038194|Drug|docetaxel|
16388333|NCT00038181|Drug|Thalidomide|
16388334|NCT00038168|Drug|Estramustine|Intravenous dose
16388335|NCT00038168|Drug|Taxol|Intravenous dose
16388336|NCT00038155|Procedure|Ambulation training|Recruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge
16388337|NCT00038142|Drug|Vincristine|2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
16388338|NCT00038142|Drug|Doxorubicin|90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.
16388339|NCT00038142|Drug|Cyclophosphamide|2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.
16388340|NCT00038142|Drug|Dexrazoxane|900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
16388341|NCT00038142|Biological|ImmTher|900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
16388342|NCT00038129|Procedure|Intramedullary nail implant|Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
16388343|NCT00038116|Procedure|embryonic dopamine cell implant surgery|Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.
16388344|NCT00038116|Procedure|placebo|sham surgery
16388345|NCT00038103|Drug|Exemestane|Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
16388346|NCT00038103|Drug|Celecoxib + Exemestane|Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
16388347|NCT00038090|Drug|Thalidomide|100 mg capsules by mouth daily each evening
16388348|NCT00038090|Drug|Dexamethasone|20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
16388349|NCT00038077|Drug|Seloken ZOK/Toprol-XL|50 mg
16388350|NCT00038077|Drug|Seloken ZOK/Toprol-XL|200 mg
16388351|NCT00038077|Drug|Placebo|
16388352|NCT00038064|Drug|Darbepoetin alfa|Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.
16388353|NCT00038064|Drug|rHuEPO|150 IU/kg TIW
16388354|NCT00038051|Drug|Hum-195/rGel|Starting Dose = 3 mg/m^2 twice weekly for 2 weeks.
16388355|NCT00038038|Drug|18F-fluoromisonidazole|Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
16388356|NCT00038038|Procedure|PET scan|Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection
16388357|NCT00038025|Drug|Deoxycoformycin (DCF)|Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.
16388358|NCT00038012|Drug|Thrombopoietin|
16388359|NCT00038012|Procedure|Platelet-pheresis|
16388360|NCT00038012|Drug|Carboplatin|
16388361|NCT00037999|Procedure|Testosterone supplement|
16388362|NCT00037986|Device|Hearing Aids|Hearing aid use
16388363|NCT00037973|Behavioral|ventilation feedback|
16388364|NCT00037973|Behavioral|exercise|
16388365|NCT00037960|Procedure|Constrained Induced Therapy|
16388366|NCT00037947|Procedure|Hearing in Multiple Sclerosis|
16388367|NCT00037934|Device|Upper extremity robot|Robotic upper extremity neuro-rehabilitation
16388368|NCT00037934|Other|Traditional Supervised Upper Extremity Exercises|Arm ergometer, reaching, and stretching exercises
16388369|NCT00037921|Procedure|Bacterial colonization|
16388370|NCT00037908|Procedure|Strength training|
16388371|NCT00037895|Procedure|Ambulation training|
16388372|NCT00037882|Drug|PEG-Intron|Once weekly injection.
16388373|NCT00037869|Drug|I-131 Metaiodobenzylguanidine|
16388374|NCT00037843|Drug|I-131 Iodocholesterol|
16388375|NCT00037830|Drug|GM1 ganglioside|100 mg twice per day by subcutaneous injection
16388376|NCT00037830|Drug|Placebo|Twice per day subcutaneous injection, equal volume as active drug
16388377|NCT00037817|Drug|Decitabine|assigned dose level on day 4 and day 10 of each 34 day cycle
16388378|NCT00037817|Biological|Depsipeptide|assigned dose level on day 4 and day 10 of each 34 day cycle
16388379|NCT00037817|Drug|Celecoxib|400mg PO BID on days 4 through 34 of each cycle
16388380|NCT00037804|Drug|Irinotecan|
16388381|NCT00037791|Drug|(PN-152,243)/PN-196,444|
16388382|NCT00004575|Drug|Miconazole, L-NMMA, Bradykinin|
16388383|NCT00001866|Procedure|horizontal muscles of the eye will be cut and then reattached in the same position|
16388384|NCT00001864|Drug|Atropine|
16388385|NCT00001864|Device|Patch|
16388386|NCT00001818|Drug|Hydroxyurea|
16388387|NCT00001688|Drug|Ritonavir|
16388388|NCT00001688|Drug|Nevirapine|
16388389|NCT00001688|Drug|Stavudine|
16388390|NCT00001542|Drug|fluconazole|
16388391|NCT00001190|Drug|Deslorelin|
16388392|NCT00037752|Drug|Sibutramine|At the baseline study visit, participants in Group 1 will be given a one month supply of 5 mg/d of sibutramine and a 1-month follow-up visit will be scheduled. After a safety evaluation at the 1-month follow-up visit, participants will have their dose of sibutramine titrated to 10 mg/d, a 1 month supply of the medication will be given to participants, and a 2-month follow-up visit will be scheduled. After a safety evaluation at the 2-month follow-up visit, participants will receive a 1 month supply of sibutramine 10 mg/d and a 3-month follow-up visit will be scheduled. At the 3-month follow-up visit, the sibutramine will be discontinued and participants will be scheduled for 4- and 5-month follow-up visits.
16388393|NCT00037752|Behavioral|Behavioral Smoking Cessation Program|Both groups of participants will take part in a behavioral smoking cessation program.
16388394|NCT00037713|Biological|BEC2 Vaccine|5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.
16388395|NCT00037700|Drug|anakinra|
16388396|NCT00037700|Drug|pegsunercept|
16388397|NCT00037687|Drug|rPAF-AH|
16388398|NCT00037674|Drug|Topiramate|
16388399|NCT00037661|Drug|INS365 Ophthalmic Solution|
16388400|NCT00037648|Drug|Anakinra|anakinra
16388401|NCT00037648|Drug|Placebo|placebo
16388402|NCT00037635|Drug|AMG 073|30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
16388403|NCT00037635|Drug|Placebo|30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
16388404|NCT00037622|Drug|ACH-126, 443 (beta-L-Fd4C)|
16388405|NCT00037609|Drug|Capecitabine|1000 mg/m^2 taken by mouth twice daily.
16388406|NCT00037609|Drug|Exisulind|125 mg taken by mouth twice daily.
16388407|NCT00037596|Drug|Gemtuzumab Ozogamicin|
16388408|NCT00037596|Drug|cytarabine.|
16388409|NCT00037583|Drug|Gemtuzumab Ozogamicin|
16388410|NCT00037570|Drug|Pantoprazole|
16388411|NCT00037557|Drug|BeneFIX|
16388412|NCT00037544|Drug|ReFacto AF|
16388413|NCT00037531|Drug|Sirolimus (RAPAMUNE)|
16388414|NCT00037518|Drug|AMG 073|
16388415|NCT00037492|Procedure|home-based sessions/family meetings with trained clinician|
16388416|NCT00037479|Drug|ceftriaxone|
16388417|NCT00037440|Genetic|Polymorphisms measured|
16388418|NCT00037219|Drug|Anidulafungin, VER002|
16388419|NCT00037206|Drug|Anidulafungin, VER002|
16388420|NCT00037180|Drug|Celecoxib|
16388421|NCT00037180|Drug|Irinotecan|
16388422|NCT00037180|Drug|5-fluorouracil|
16388423|NCT00037180|Drug|Leucovorin|
16388424|NCT00037167|Device|Exercise poles|
16388425|NCT00037154|Drug|Saw Palmetto|
16388426|NCT00037141|Drug|dehydrated alcohol|
16388427|NCT00037128|Drug|GL701|
16388428|NCT00037115|Drug|interferon beta 1a|
16388429|NCT00037115|Drug|methotrexate|
16388430|NCT00037115|Drug|methylprednisolone|
16388431|NCT00037102|Drug|interferon beta 1a|
16388432|NCT00037102|Drug|methotrexate|
16388433|NCT00037089|Drug|UFT (Tegafur/Uracil)|
16388434|NCT00037063|Drug|Thiamine hydrochloride|
16388435|NCT00037063|Drug|Riboflavin|
16388436|NCT00037063|Drug|Ascorbic acid|
16388437|NCT00037063|Drug|Vitamin E|
16388438|NCT00037050|Drug|Linezolid|
16388439|NCT00037050|Drug|Vancomycin|
16388440|NCT00037050|Drug|Oxacillin|
16388441|NCT00037050|Drug|Dicloxacillin|
16388442|NCT00036647|Drug|Tarceva (erlotinib HCl, OSI-774 )|
16388443|NCT00036634|Drug|Tenofovir DF|Tenofovir DF tablet administered orally once daily
16388444|NCT00036634|Drug|Tenofovir alafenamide|Tenofovir alafenamide tablet(s) administered orally once daily
16388445|NCT00036621|Drug|BMS-275291|
16388446|NCT00036608|Drug|Entecavir|
16388447|NCT00036582|Drug|Clozapine|
16388448|NCT00036569|Procedure|adjuvant therapy|
16388449|NCT00036569|Biological|pegylated interferon alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
16388450|NCT00036556|Drug|Atrasentan|
16388451|NCT00036543|Drug|Atrasentan|
16388452|NCT00036517|Drug|PHY906|
16388453|NCT00036504|Drug|Insulin Lispro low mixture|
16388454|NCT00036491|Drug|Rituximab|Subjects received four weekly infusions of rituximab at a dose of 375 mg/m^2
16388455|NCT00036465|Behavioral|Treatment regimen change|
16388456|NCT00036452|Drug|lopinavir/ritonavir|
16388457|NCT00036452|Drug|emtricitabine|
16388458|NCT00036452|Drug|stavudine|
16388459|NCT00036452|Drug|tenofovir DF|
16388460|NCT00036439|Drug|Infliximab|
16388461|NCT00036426|Biological|FavId (Id-KLH) active immunotherapy|
16388462|NCT00036413|Drug|TCH346|
16388463|NCT00036400|Drug|epoetin alfa|
16388464|NCT00036387|Drug|Infliximab|
16388465|NCT00036374|Drug|Infliximab|
16388466|NCT00036361|Drug|Aripiprazole|
16388467|NCT00036348|Drug|Aripiprazole|
16388468|NCT00036335|Drug|Duloxetine Hydrochloride|
16388469|NCT00036309|Drug|Duloxetine Hydrochloride|
16388470|NCT00036296|Drug|talampanel|75mg per day divided into 3 doses for 22 days
16388471|NCT00036283|Drug|Celecoxib|
16388472|NCT00036270|Drug|exemestane (Aromasin)|exemestane, orally, 25 mg, for 5 years
16388473|NCT00036270|Drug|tamoxifen + exemestane|tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
16388474|NCT00036257|Drug|CP-461|
16388475|NCT00036244|Drug|RG1068 (Synthetic Human Secretin)|
16388476|NCT00036231|Drug|RG1068 (Synthetic Human Secretin)|
16388477|NCT00036218|Drug|sumanirole|
16388478|NCT00036218|Drug|ropinirole|
16388479|NCT00036205|Drug|sumanirole|
16388480|NCT00036192|Drug|FK614|
16388481|NCT00036179|Drug|FK463|
16388482|NCT00036166|Drug|FK463|
16388483|NCT00036153|Drug|Tacrolimus (Prograf®)|
16388484|NCT00036153|Drug|Methotrexate|
16388485|NCT00036140|Drug|Investigational drug|
16388486|NCT00036127|Drug|aripiprazole|
16388487|NCT00036114|Drug|aripiprazole|
16388488|NCT00036101|Drug|aripiprazole|
16388489|NCT00036088|Drug|Olanzapine|
16388490|NCT00036075|Drug|CP-461|
16388491|NCT00036062|Drug|Sivelestat|
16388492|NCT00036036|Drug|CP-461|
16388493|NCT00036023|Drug|darbepoetin alfa|
16388494|NCT00035997|Drug|Zometa|
16388495|NCT00035984|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388496|NCT00035984|Drug|AC2993|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
16388497|NCT00035984|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
16388498|NCT00035984|Drug|Placebo|Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
16388499|NCT00035971|Drug|raloxifene HCI and alendronate Na|
16388500|NCT00035958|Drug|Prednisone|
16388501|NCT00035958|Drug|Methotrexate|
16388502|NCT00035958|Drug|Etanercept|
16388503|NCT00035945|Drug|ISIS 14803|
16388666|NCT00034333|Drug|MTC-DOX for Injection|
16388504|NCT00035932|Drug|Atazanavir + ritonavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
16388505|NCT00035932|Drug|Atazanavir + saquinavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
16388506|NCT00035932|Drug|Lopinavir/ritonavir + tenofovir + nucleoside|Active Comparator, Capsules, tablets, Oral
16388507|NCT00035919|Genetic|Mx-dnG1 Retroviral Vector|
16388508|NCT00035906|Drug|DEX PS DDS®|
16388509|NCT00035893|Drug|poly I-poly C12U|200-400 mg IV infusions 2x/week for 64 weeks
16388510|NCT00035880|Drug|ABX-CBL|
16388511|NCT00035867|Drug|TLK199 HCl Liposomes for Injection|
16388512|NCT00035854|Drug|Zyvox® / Linezolid|
16388513|NCT00035841|Drug|TLK286|
16388514|NCT00035828|Drug|ABX-IL8|
16388515|NCT00035815|Drug|Insulin like growth factor, type 1|0.05 mg per kg body weight given subcutaneously twice daily
16388516|NCT00035815|Drug|Placebo|The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.
16388517|NCT00035802|Drug|Topiramate|"Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.
~OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months."
16388518|NCT00035802|Drug|Placebo|Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
16388519|NCT00035789|Drug|Entecavir|
16388520|NCT00035633|Drug|Entecavir|
16388521|NCT00035620|Drug|pegfilgrastim|pegfilgrastim
16388522|NCT00035620|Drug|filgrastim|filgrastim
16388523|NCT00035607|Drug|Darbepoetin alfa SC|Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
16388524|NCT00035607|Drug|Darbepoetin alfa IV|Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
16388525|NCT00035594|Drug|pegfilgrastim|Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
16388526|NCT00035581|Drug|poly I-poly C12U|200-400 mg IV infusions 2x/week for 24 weeks
16388527|NCT00035568|Drug|Glucovance (metformin HCl/glyburide)|
16388528|NCT00035568|Drug|or Metformin HCl alone|
16388529|NCT00035568|Drug|or Glyburide alone.|
16388530|NCT00035555|Drug|Belatacept|Solution, intravenous
16388531|NCT00035555|Drug|Cyclosporine|Oral, capsule
16388532|NCT00035555|Drug|Mycophenolate mofetil (MMF)|Oral, capsule
16388533|NCT00035555|Drug|Corticosteroids|Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
16388534|NCT00035542|Drug|Glucovance (metformin HCl/glyburide)|
16388535|NCT00035542|Drug|metformin HCl|
16388536|NCT00035542|Drug|glyburide|
16388537|NCT00035529|Drug|Placebo|Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
16388538|NCT00035529|Drug|BMS 188667 (Abatacept)|Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
16388539|NCT00035529|Drug|BMS 188667 (Abatacept)|Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
16388540|NCT00035516|Drug|Epothilone|
16388541|NCT00035503|Drug|etiprednol dicloacetate|
16388542|NCT00035490|Drug|Azimilide Dihydrochloride|125 mg azimilide, once a day for one year
16388543|NCT00035490|Drug|placebo|placebo tablet, once daily for one year
16388544|NCT00035490|Drug|Azimilide Dihydrochloride|75 mg azimilide, once a day for one year
16388545|NCT00035477|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
16388546|NCT00035477|Drug|Placebo|placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
16388547|NCT00035464|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets, twice a day for 6 months
16388548|NCT00035464|Drug|Placebo|placebo tablets, twice a day for 6 months
16388549|NCT00035451|Drug|Azimilide Dihydrochloride|125 mg azimilide tablets, twice a day for 6 months
16388550|NCT00035451|Drug|Placebo|tablets, twice daily for 6 months
16388551|NCT00035451|Drug|Sotalol|160 mg sot twice daily for 6 months
16388552|NCT00035438|Drug|St. John's Wort|
16388553|NCT00035425|Drug|linezolid|600mg every 12 hours
16388554|NCT00035425|Drug|vancomycin|1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours.
16388555|NCT00035412|Drug|St. John's Wort|
16388556|NCT00035399|Procedure|Acupuncture|
16388557|NCT00035360|Drug|PEG-Intron|
16388558|NCT00035347|Drug|IV azithromycin|500 mg once daily
16388559|NCT00035347|Drug|ceftriaxone|1 gram once daily for 2 to 5 days
16388560|NCT00035347|Drug|oral azithromycin|2 x 250 mg once daily
16388561|NCT00035347|Drug|IV levofloxacin|500 mg once daily
16388562|NCT00035347|Drug|oral levofloxacin|500 mg once daily
16388563|NCT00035386|Procedure|trans-right ventricular alcohol septal ablation (TRVASA)|
16388564|NCT00035334|Drug|NC-503 (Anti-amyloidotic (AA) Agent)|
16388565|NCT00035321|Drug|Olanzapine|
16388566|NCT00035321|Drug|Fluoxetine|
16388567|NCT00035308|Drug|Abetimus sodium (LJP 394)|
16388568|NCT00035295|Drug|MK0869, aprepitant|
16388569|NCT00035295|Drug|Comparator: placebo|
16388570|NCT00035282|Drug|aprepitant|
16388571|NCT00035282|Drug|Comparator: placebo (unspecified)|
16388572|NCT00035269|Drug|Antibiotic|
16388573|NCT00035256|Drug|teriparatide|
16388574|NCT00035256|Drug|raloxifene HCl|
16388575|NCT00035256|Drug|placebo|
16388667|NCT00034307|Drug|sitaxsentan sodium|
16388668|NCT00034294|Drug|GT160-246|
16388919|NCT00029393|Procedure|Hematopoietic Stem Cell Transplantation|
16388576|NCT00035243|Drug|epothilone b|EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.
16388577|NCT00035230|Drug|Topiramate|
16388578|NCT00035204|Drug|galantamine|
16388579|NCT00035191|Drug|galantamine|
16388580|NCT00035178|Drug|Argatroban|
16388581|NCT00035165|Drug|epothilone b|intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off
16388582|NCT00035152|Drug|Paclitaxel and carboplatin|
16388583|NCT00035139|Drug|methylphenidate|
16388584|NCT00035126|Drug|epothilone b|
16388585|NCT00035113|Drug|epothilone b|
16388586|NCT00035100|Drug|epothilone b|
16388587|NCT00035087|Drug|epothilone b|
16388588|NCT00035074|Drug|Methotrexate|
16388589|NCT00035061|Drug|pemetrexed|
16388590|NCT00035048|Drug|aprepitant|
16388591|NCT00035048|Drug|Comparator: placebo (unspecified)|
16388592|NCT00035035|Drug|GEMZAR|
16388593|NCT00035035|Drug|ALIMTA|
16388594|NCT00035022|Drug|BCX-1777|
16388595|NCT00035009|Drug|MK0869, aprepitant|
16388596|NCT00035009|Drug|Comparator: paroxetine HCL|
16388597|NCT00034983|Drug|aprepitant|
16388598|NCT00034983|Drug|Comparator: paroxetine HCL|
16388599|NCT00034970|Behavioral|Mindfulness-based at therapy|
16388600|NCT00034957|Drug|Investigational drug|
16388601|NCT00034944|Drug|MK0869, aprepitant|
16388602|NCT00034944|Drug|Comparator: placebo|
16388603|NCT00034918|Drug|ZD6474|
16388604|NCT00034905|Drug|quetiapine fumarate vs risperidone|
16388605|NCT00034892|Drug|Olanzapine, risperidone|
16388606|NCT00034879|Drug|ZD1839 (Gefitinib)|
16388607|NCT00034866|Drug|Protease inhibitor tipranavir|
16388608|NCT00034853|Drug|meloxicam oral suspension|
16388609|NCT00034853|Drug|naproxen oral suspension|
16388610|NCT00034840|Drug|telmisartan, valsartan|
16388611|NCT00034827|Drug|CI-1040|
16388612|NCT00034814|Drug|Talampanel|Non-enzyme-inducing TLP 35mg TID
16388613|NCT00034814|Drug|Placebo|Enzyme-inducing placebo TID
16388614|NCT00034814|Drug|Talampanel|Enzyme-inducing Talampanel 35 mg TID
16388615|NCT00034814|Drug|Talampanel|Enzyme-inducing TLP 50mg TID
16388616|NCT00034814|Drug|Placebo|Non-enzyme-inducing placebo TID
16388617|NCT00034814|Drug|Talampanel|Non-enzyme-inducing TLP 25mg TID
16388618|NCT00034801|Drug|olanzapine|
16388619|NCT00034801|Drug|ziprasidone|
16388620|NCT00034788|Drug|Becaplermin|
16388621|NCT00034775|Drug|risperidone|
16388622|NCT00034762|Drug|risperidone|
16388623|NCT00034749|Drug|Risperidone|
16388624|NCT00034736|Drug|Levofloxacin|
16388625|NCT00034710|Drug|Capsaicin Patch|
16388626|NCT00034697|Drug|temozolomide|
16388627|NCT00034684|Drug|Farnesyl Protein Transferase Inhibitor|
16388628|NCT00034671|Drug|Posaconazole oral suspension|
16388629|NCT00034658|Drug|Posaconazole|
16388630|NCT00034645|Drug|Posaconazole oral suspension|
16388631|NCT00034632|Drug|Posaconazole oral suspension|
16388632|NCT00034619|Drug|ALIMTA|
16388633|NCT00034619|Drug|Oxaliplatin|
16388634|NCT00034606|Drug|Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)|
16388635|NCT00034593|Drug|ALIMTA|
16388636|NCT00034593|Drug|gemcitabine|
16388637|NCT00034580|Drug|olanzapine|
16388638|NCT00034580|Drug|risperidone|
16388639|NCT00034554|Biological|gp75 DNA vaccine|6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5* patient safely completing the 2nd vaccination at the lower dose level.
16388640|NCT00034541|Biological|cetuximab|400 mg/m2 i.v. over 120 minutes
16388641|NCT00034541|Drug|paclitaxel|225 mg/m2, infusion
16388642|NCT00034541|Drug|carboplatin|30-minute AUC = 6, infusion.
16388643|NCT00034528|Drug|Busulfan|0.8 mg/kg/d administered as a single intravenous infusion over 3 hours for 4 days. All infusions are anticipated to be given in the outpatient clinic.
16388644|NCT00034528|Drug|Fludarabine|30 mg/m^2/d administered as a bolus infusion over 30 minutes for 4 days. All infusions are anticipated to be given in the outpatient clinic.
16388645|NCT00034528|Drug|FK506|0.15 mg/kg taken orally daily for 12 to 14 weeks
16388646|NCT00034528|Drug|Prednisone|0.5 mg/kg taken orally four times daily on Day 7 and increase to 1 mg/kg taken orally four times daily on Day 14. Participants will continue regimen until Day 30 before a 20-25% taper per week.
16388647|NCT00034515|Drug|denufosol tetrasodium (INS37217) Inhalation Solution|
16388648|NCT00034502|Drug|ALIMTA|
16388649|NCT00034502|Drug|irinotecan|
16388650|NCT00034489|Drug|pemetrexed|
16388651|NCT00034489|Drug|gemcitabine|
16388652|NCT00034476|Drug|sPLA2 Inhibitor|
16388653|NCT00034463|Drug|ALIMTA|
16388654|NCT00034463|Drug|folic acid|
16388655|NCT00034463|Drug|multi-vitamins|
16388656|NCT00034450|Drug|L-carnitine|
16388657|NCT00034385|Drug|Valganciclovir|
16388658|NCT00034372|Drug|oregovomab|
16388659|NCT00034359|Drug|ACH-126,443|
16388660|NCT00034359|Drug|Lamivudine|
16388661|NCT00034359|Drug|Placebo|
16388662|NCT00017862|Drug|SCH55700|
16388663|NCT00034346|Drug|ABX-EGF|
16388664|NCT00034346|Drug|paclitaxel|
16388665|NCT00034346|Drug|carboplatin|
16388669|NCT00034281|Drug|TAK-165|Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
16388670|NCT00034268|Drug|LY900003|
16388671|NCT00034255|Drug|INGAP Peptide|
16388672|NCT00034203|Drug|efalizumab|
16388673|NCT00034190|Drug|S-8184 Paclitaxel Injectable Emulsion|
16388674|NCT00034177|Drug|S-8184 Paclitaxel Injectable Emulsion|
16388675|NCT00034177|Drug|Experimental Arm: TOCOSOL Paclitaxel|Doses of 80, 100 and 120mg/m2
16388676|NCT00034242|Drug|high-dose intravenous immunoglobulin (IVIG)|
16388677|NCT00034229|Drug|Felbamate|
16388678|NCT00034164|Drug|S-8184 Paclitaxel Injectable Emulsion|
16388679|NCT00034151|Drug|S-8184 Paclitaxel Injectable Emulsion|
16388680|NCT00034138|Drug|oregovomab|
16388681|NCT00034125|Drug|LY353381|
16388682|NCT00034125|Drug|tamoxifen|
16388683|NCT00034112|Procedure|osteopathic manipulative treatment|
16388684|NCT00034086|Drug|Lopinavir/Ritonavir|
16388685|NCT00034086|Drug|Lamivudine/Zidovudine|
16388686|NCT00034086|Drug|Tenofovir disoproxil fumarate|
16388687|NCT00034086|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
16388688|NCT00034086|Drug|Lamivudine|
16388689|NCT00034086|Drug|Stavudine|
16388690|NCT00034086|Drug|Zidovudine|
16388691|NCT00034086|Drug|Didanosine|
16388692|NCT00034086|Biological|Lyme Disease Vaccine Recombinant OspA|
16388693|NCT00034086|Biological|Haemophilus B Conjugate Vaccine|
16388694|NCT00034060|Drug|Etanercept|
16388695|NCT00034047|Procedure|Acupuncture|
16388696|NCT00034047|Drug|Chinese Products|
16388697|NCT00034047|Drug|Nafarelin|
16388698|NCT00034034|Procedure|Acupuncture|
16388699|NCT00034021|Drug|Ginkgo Biloba|
16388700|NCT00034021|Behavioral|Sex Therapy (genital focus)|
16388701|NCT00034008|Behavioral|Healing Touch|
16388702|NCT00033982|Drug|Posaconazole|
16388703|NCT00033956|Drug|M40403|
16388704|NCT00033943|Drug|deligoparin|
16388705|NCT00033917|Drug|indomethacin|an anti-inflammatory drug
16388706|NCT00033917|Drug|placebo|saline
16388707|NCT00033904|Drug|autologous human tumor-derived HSPPC-96|
16388708|NCT00033891|Drug|Infliximab|
16388709|NCT00033878|Drug|Noni Extract|
16388710|NCT00033865|Behavioral|Yoga, Relaxation Exercises, Sleep Hygiene|Sleep hygiene and relaxation exercises, with additional yoga
16388711|NCT00033852|Procedure|Massage Therapy|
16388712|NCT00033839|Drug|Civamide (Zucapsaicin)|
16388713|NCT00033813|Drug|Oxatomide (tinset)|
16388714|NCT00033215|Drug|S-3304|
16388715|NCT00033202|Drug|Gimatecan® (ST-1481)|
16388716|NCT00033189|Drug|Coenzyme Q10|
16388717|NCT00033176|Drug|Alpha Lipoic Acid|
16388718|NCT00033163|Drug|Adefovir dipivoxil|
16388719|NCT00033163|Drug|Tenofovir disoproxil fumarate|
16388720|NCT00033150|Behavioral|Fast ForWord|
16388721|NCT00033150|Behavioral|Computer Assisted Language Intervention|
16388722|NCT00033150|Behavioral|Individual Language Intervention|
16388723|NCT00033150|Behavioral|Academic enrichment|
16388724|NCT00033124|Behavioral|Behavior Therapy|
16388725|NCT00033111|Drug|Cabergoline|
16388726|NCT00033111|Drug|Placebo|sugar pill manufactured to mimic cabergoline 05mg tablet
16388727|NCT00033098|Drug|Metyrapone|
16388728|NCT00033085|Drug|Ondansetron|
16388729|NCT00033072|Drug|Selegiline|
16388730|NCT00033059|Drug|Tolcapone|
16388731|NCT00033046|Drug|Modafinil|
16388732|NCT00033033|Drug|Reserpine|
16388733|NCT00033020|Behavioral|Behavior Therapy|
16388734|NCT00033007|Behavioral|Behavior Therapy|
16388735|NCT00032994|Behavioral|Behavior Therapy|
16388736|NCT00032981|Behavioral|Behavior Therapy|
16388737|NCT00032968|Drug|Buprenorphine/naloxone|
16388738|NCT00032955|Drug|Buprenorphine/naloxone|
16388739|NCT00032942|Drug|Lofexidine|
16388740|NCT00032929|Drug|Selegiline|
16388741|NCT00032916|Drug|NS2359|
16388742|NCT00032903|Drug|Gimatecan® (ST 1481)|
16388743|NCT00032890|Drug|glucosamine|
16388744|NCT00032890|Drug|chondroitin sulfate|
16388745|NCT00032890|Drug|glucosamine and chondroitin sulfate combined|
16388746|NCT00032890|Drug|celecoxib|
16388747|NCT00032838|Drug|Yohimbine|
16388748|NCT00032825|Drug|Ketaconazole|
16388749|NCT00032825|Drug|Docetaxel|
16388750|NCT00032799|Drug|natalizumab|
16388751|NCT00032786|Drug|natalizumab|
16388752|NCT00032773|Drug|pentostatin for injection|
16388753|NCT00032812|Drug|Raclopride|
16388754|NCT00032760|Behavioral|Meditation|
16388755|NCT00032747|Drug|Vasopressin V2 Receptor Antagonist|
16388756|NCT00032734|Drug|satavaptan (SR121463B)|
16388757|NCT00032721|Procedure|Reiki; Subtle energy therapy|
16388758|NCT00032708|Biological|Dryvax|
16388759|NCT00032695|Drug|methionine|
16388760|NCT00032669|Drug|HAART|
16388761|NCT00032643|Drug|DITPA|
16388762|NCT00032630|Procedure|Coronary artery bypass - on-pump|CABG procedure performed on heart lung machine
16388763|NCT00032630|Procedure|Coronary artery bypass - off-pump|CABG procedure performed without the use of the heart lung machine
16388764|NCT00032617|Procedure|Prolonged Exposure|trauma-focused exposure therapy
16388765|NCT00032617|Procedure|Present Centered Therapy|therapy that focuses on current problems
16388766|NCT00032591|Procedure|Weekly patient self-testing of prothrombin time|
16388767|NCT00032591|Other|High quality anticoagulation management (HQACM) with conventional monthly testing|HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
16388768|NCT00032526|Drug|Corticosteroids|
16388769|NCT00032526|Behavioral|Classical conditioning to corticosteroid|
16388770|NCT00032500|Drug|Echinacea|
16388915|NCT00029497|Procedure|Acupuncture|
16388771|NCT00032487|Drug|Insulin|Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2
16388772|NCT00032487|Drug|Glimepiride|Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2
16388773|NCT00032487|Drug|Rosiglitazone|Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2
16388774|NCT00032487|Drug|Metformin|Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm
16388775|NCT00032474|Drug|Ginkgo biloba extract|
16388776|NCT00032448|Procedure|Standardized tension-free herniorrhaphy with prosthesis|Compare the effect of two typs of operative treatment of inguinal hernia.
16388777|NCT00032435|Drug|PAL-40 Active|
16388778|NCT00032435|Drug|PAL-40 Placebo|
16388779|NCT00032422|Procedure|Acupuncture|
16388780|NCT00032409|Behavioral|Music therapy-based relaxation/stress reduction|
16388781|NCT00032396|Drug|Retisert Implant|
16388782|NCT00032383|Behavioral|Tai Chi|
16388783|NCT00032370|Procedure|Vascular surgery with best medical treatment|Patients undergo scheduled vascular surgery
16388784|NCT00032370|Procedure|Coronary artery bypass grafting (CABG)|Coronary artery bypass grafting prior to vascular surgery
16388785|NCT00032370|Procedure|Percutaneous transluminal coronary angioplasty (PTCA)|Cardiac revascularization via PTCA prior to vascular surgery
16388786|NCT00032357|Procedure|Ferritin reduction to 25 ng/ml by phlebotomy|
16388787|NCT00032344|Procedure|Colonoscopy|Phase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up
16388788|NCT00032331|Procedure|PET Imaging|
16388789|NCT00032331|Procedure|CT scan|
16388790|NCT00032305|Drug|Visilizumab|
16388791|NCT00032292|Drug|Visilizumab|
16388792|NCT00032279|Drug|Visilizumab|
16388793|NCT00032240|Device|Shoe Insert|
16388794|NCT00032227|Procedure|Early Carpal Tunnel Release for Mild or Moderate CTS|Either open or endoscopic surgery
16388795|NCT00032227|Other|MR Nerve Imaging for CTS|New diagnostic test for CTS to directly image the median nerve
16388796|NCT00031551|Drug|Etanercept|
16388797|NCT00031551|Drug|Placebo|
16388798|NCT00031512|Drug|Placebo|Placebo.
16388799|NCT00031512|Drug|Pleconaril (VP63843)|5 mg/kg /dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation and 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.
16388800|NCT00031499|Drug|Azithromycin|Single 2 gram oral dose (4 tablets) at Day 1.
16388801|NCT00031499|Drug|Benzathine Penicillin|Supplied in pre-filled syringes containing 1.2 million units of benzathine penicillin; 2.4 million units administered intramuscularly at Day 1, in one or both buttocks.
16388802|NCT00031499|Drug|Doxycycline|Baseline visit, 28 capsules dispensed, for a dose of 100 mg twice a day (BID).
16388803|NCT00031486|Drug|Valacyclovir|Valacyclovir is a L-valyl ester of acyclovir. Valacyclovir is provided in 500 mg tablets, 4 tablets (500 mg tablets) 3 times a day (every 8 hours) for 90 days.
16388804|NCT00031486|Drug|Placebo|Placebo (identical to active drug in appearance) 500 mg tablets, 4 tablets 3 times daily for 90 days.
16388805|NCT00031473|Drug|Virazole (Ribavirin) Inhalation Solution|
16388806|NCT00031460|Drug|Acyclovir|Oral banana flavored acyclovir suspension: 300 mg/m^2/dose three times a day (TID), to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.
16388807|NCT00031460|Drug|Placebo|Oral banana flavored placebo suspension: to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area.
16388808|NCT00031447|Drug|Acyclovir|Oral suspension 300 mg/m^2/dose, 3 times per day (TID), for 6 months.
16388809|NCT00031447|Drug|Placebo|Placebo identical to oral acyclovir suspension in appearance and taste.
16388810|NCT00031434|Drug|Valganciclovir|Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to ganciclovir on absorption. Valganciclovir oral syrup formulation for administration will be provided as a 15g powder blend containing 3g valganciclovir base, for constitution in 120 mL amber glass bottles. The beginning oral valganciclovir dose under investigation is 14 mg/kg. The dose of oral valganciclovir syrup will be adjusted for the baby's weight and renal function. Weights upon which dosage will be adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35.
16388811|NCT00031434|Drug|Ganciclovir|Ganciclovir for intravenous infusion will be provided as sterile, lyophilized powder in sealed vials containing 500 mg ganciclovir for re-constitution. The dose of intravenous ganciclovir is 6 mg/kg. Intravenous ganciclovir will be adjusted for the baby's weight and renal function. Weights upon which dosage adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35. Each dose of intravenous ganciclovir should be given over 1 hour using an intravenous pump.
16388812|NCT00031395|Drug|clonidine|Clonidine is FDA-approved for the treatment of hypertension in adults.
16388813|NCT00031395|Drug|methylphenidate|MPH is FDA-approved for the treatment of ADHD symptoms in children.
16388814|NCT00031395|Other|placebo|an inactive substance
16388815|NCT00031343|Drug|highly active antiretroviral therapy (HAART)|
16388816|NCT00031317|Drug|Paroxetine|
16388817|NCT00031317|Drug|Clozapine|
16388818|NCT00031291|Drug|Anthrax Immune Globulin|
16388819|NCT00031278|Drug|CPG 7909|Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
16388820|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
16388821|NCT00031278|Drug|CPG 7909|Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
16388822|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
16388823|NCT00031278|Drug|CPG 7909|Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
16388824|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
16388916|NCT00029497|Drug|Amitriptyline|
16388917|NCT00029484|Behavioral|Tai chi chih|
16388825|NCT00031278|Drug|CPG 7909|Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
16388826|NCT00031278|Drug|Herceptin®|Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
16388827|NCT00031265|Procedure|Family Intervention Telephone Tracking|
16388828|NCT00031187|Drug|SGN-15 (cBR96-doxorubicin immunoconjugate)|
16388829|NCT00031187|Drug|Taxotere (docetaxel)|
16388830|NCT00031161|Drug|Nitisinone (NTBC)|
16388831|NCT00031161|Drug|Dichloroacetate|
16388832|NCT00031161|Behavioral|Low-tyrosin diet|
16388833|NCT00031148|Drug|Recombinant Human Keratinocyte Growth Factor (rHuKGF)|
16388834|NCT00031135|Drug|Choline Chloride|
16388835|NCT00031122|Other|No Intervention|There is no intervention in this study
16388836|NCT00031109|Biological|gp160 MN/LAI-2|
16388837|NCT00031109|Biological|Aluminum hydroxide|
16388838|NCT00031096|Drug|Azelaic Acid Gel 15% (Finacea, BAY39-6251)|Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
16388839|NCT00031096|Drug|Vehicle gel (SH H 655 PBA)|Vehicle gel (SH H 655 PBA) applied topically two times per day.
16388840|NCT00031083|Genetic|Interferon-beta|
16388841|NCT00031070|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16388842|NCT00031070|Drug|Cyclosporine|
16388843|NCT00031070|Biological|Hepatitis A Vaccine (Inactivated)|
16388844|NCT00031070|Drug|Efavirenz|
16388845|NCT00031070|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|
16388846|NCT00031070|Biological|Rabies Vaccine|
16388847|NCT00031057|Drug|Thiamine hydrochloride|
16388848|NCT00031057|Drug|Riboflavin|
16388849|NCT00031044|Drug|Enfuvirtide|
16388850|NCT00031044|Drug|Amdoxovir|
16388851|NCT00031031|Drug|Kanglaite Injection (KLT)|
16388852|NCT00031018|Drug|Aricept|
16388853|NCT00031018|Drug|IFN-alpha2A|
16388854|NCT00031005|Procedure|modified stem cell transplant|
16388855|NCT00030992|Drug|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
16388856|NCT00030992|Drug|Ranitidine|50 mg 30-60 minutes prior to Ixabepilone (BMS-247550)
16388857|NCT00030992|Drug|Diphenhydramine|50 mg intravenously 30-60 minutes prior to Ixabepilone (BMS-247550)
16388858|NCT00030979|Drug|Donepezil|
16388859|NCT00030966|Drug|Natalizumab|Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
16388860|NCT00030966|Drug|Placebo|Placebo monthly infusion for up to 116 weeks.
16388861|NCT00030238|Drug|Calcium supplement|Calcium Carbonate capsules prepared by NIH PDS
16388862|NCT00030238|Drug|Placebo|Placebo capsules prepared by the NIH PDS to be identical to Calcium Carbonate capsules
16388863|NCT00030225|Biological|ELAD|
16388864|NCT00030225|Other|Standard of care (Control)|
16388865|NCT00030186|Drug|CEP-701 60mg|60mg orally 2 times a day for 28 days
16388866|NCT00030186|Drug|Cep-701 80mg|80mg 2 times a day, dependent upon response to cycle 1
16388867|NCT00030186|Drug|Cep-701 40mg|40mg 2 times a day, dependent upon response to cycle 1
16388868|NCT00030173|Drug|Epothilone D (KOS-862)|
16388869|NCT00030160|Behavioral|Strength Training|
16388870|NCT00030147|Drug|Raloxifene|60 mg a day orally administered
16388871|NCT00030147|Drug|Rimostil|1000 mg twice a day administered orally
16388872|NCT00030147|Drug|Transdermal Estradiol|100 microgram per day transdermal estradiol
16388873|NCT00030147|Drug|Placebo skin patch and placebo tablets|matched placebo skin patch to transdermal estradiol and matched tablets to either Raloxifene or Rimostil
16388874|NCT00030121|Drug|recombinant human atrial natriuretic polypeptide|
16388875|NCT00030069|Drug|Calcitriol|
16388876|NCT00030069|Drug|Dexamethasone|
16388877|NCT00030056|Drug|GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)|
16388878|NCT00030043|Device|Penetrating auditory brainstem implant|
16388879|NCT00030030|Drug|Silymarin (milk thistle)|
16388880|NCT00030004|Procedure|spinal manipulation|
16388881|NCT00030004|Drug|midazolam|
16388882|NCT00029991|Drug|Gingko Biloba (Herb)|
16388883|NCT00029926|Drug|2-deoxy-2 [F-18] fluoro-2-d-glucose|
16388884|NCT00029913|Other|Observation|Observation of participants who received HIV preventive vaccine and became infected.
16388885|NCT00029900|Drug|ADI PEG|
16388886|NCT00029874|Drug|Minocycline|
16388887|NCT00029861|Drug|Rimonabant (SR141716)|
16388888|NCT00029848|Drug|Rimonabant (SR141716)|
16388889|NCT00029835|Drug|Rimonabant (SR141716)|
16388890|NCT00029822|Drug|Alfuzosin (SL770499)|
16388891|NCT00029809|Behavioral|Chinese exercise modalities|
16388892|NCT00029796|Drug|soy isoflavones|
16388893|NCT00029783|Procedure|Distant Healing|
16388894|NCT00029770|Procedure|Chiropractic spinal manipulation|
16388895|NCT00029770|Drug|Acetaminophen|
16388896|NCT00029770|Behavioral|Self-care|
16388897|NCT00029770|Drug|Non-Steroidal anti-inflammatory drugs (NSAIDS)|
16388898|NCT00029770|Drug|Tylenol with codeine|
16388899|NCT00029757|Drug|Estrogen|
16388900|NCT00029731|Drug|Arginine hydrochloride|
16388901|NCT00029692|Drug|Ginseng|
16388902|NCT00029692|Drug|Ginkgo|
16388903|NCT00029679|Drug|Gingko biloba|
16388904|NCT00029679|Drug|Borage oil|
16388905|NCT00029666|Device|Neopulse Magnetic Stimulator|
16388906|NCT00029627|Drug|Yohimbine|
16388907|NCT00029614|Drug|Atomoxetine|
16388908|NCT00029575|Device|Surgi-Vision Guidewire Coil|
16388909|NCT00029536|Biological|Progesterone Lozenges|200mg Progesterone Lozenges
16388910|NCT00029536|Other|Matched Placebo Lozenges|Matched Placebo Lozenges
16388911|NCT00029523|Drug|Intrathecal (injected into the spinal fluid) DepoCyt|
16388912|NCT00029523|Drug|Intrathecal methotrexate|
16388913|NCT00029523|Drug|Intrathecal cytarabine (also known as ara-C)|
16388914|NCT00029510|Drug|Magnesium|
16388921|NCT00029380|Drug|Sangstat|
16388922|NCT00029380|Drug|Cyclophosphamide|
16388923|NCT00029380|Drug|Busulfan|
16388924|NCT00029380|Drug|Mycophenolate Mofetil|
16388925|NCT00029380|Drug|Cyclosporine|
16388926|NCT00029380|Procedure|Cord Blood Transplantation|
16388927|NCT00029341|Behavioral|Treatment Interruption|
16388928|NCT00029328|Drug|etanercept|
16388929|NCT00029315|Drug|Recombinant Tissue Plasminogen Activator (rt-PA)|
16388930|NCT00029289|Drug|Lutein (10 or 30 mg/day) capsules|
16388931|NCT00029276|Procedure|Prefrontal transcranial magnetic brain stimulation|
16388932|NCT00029263|Drug|herbals|
16388933|NCT00029250|Drug|Garlic powder standardized to allicin|
16388934|NCT00029237|Behavioral|Cognitive-behavioral relaxation (Positively Living)|
16388935|NCT00029237|Behavioral|Spiritual growth group|
16388936|NCT00029237|Behavioral|Focused Tai Chi|
16388937|NCT00029224|Drug|zoledronic acid|
16388938|NCT00029211|Drug|Echinacea|
16388939|NCT00029198|Procedure|massage|15 massage given tid
16388940|NCT00029198|Procedure|Sham massage|non-massage touch
16388941|NCT00029185|Drug|Dehydrex|
16388942|NCT00029172|Other|case management|
16388943|NCT00029159|Drug|estrogen|Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.
16388944|NCT00029159|Drug|androgen|Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years
16388945|NCT00029159|Other|placebo|an inactive substance
16388946|NCT00029146|Procedure|extracranial-intracranial bypass surgery|Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy plus best current practice medical therapy
16388947|NCT00029146|Drug|best medical therapy|best current practice medical therapy
16388948|NCT00029133|Procedure|mild intraoperative hypothermia (33 degrees Celsius)|
16388949|NCT00028431|Biological|MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine|
16388950|NCT00028418|Drug|Clofarabine|
16388951|NCT00028405|Drug|LS 11(Taporfin Sodium)|
16388952|NCT00028405|Device|Lumaflex Light Delivery Catheter|
16388953|NCT00029107|Drug|Rituximab|anti-CD20 monoclonal antibody
16388954|NCT00029042|Drug|Infliximab|
16388955|NCT00028379|Procedure|Transcranial magnetic stimulation (TMS)|
16388956|NCT00028366|Drug|Fosamprenavir|
16388957|NCT00028366|Drug|Lopinavir/Ritonavir|
16388958|NCT00028366|Drug|Ritonavir|
16388959|NCT00028366|Drug|Tenofovir disoproxil fumarate|
16388960|NCT00028353|Drug|GTX-006 (Acapodene)|
16388961|NCT00028327|Drug|Lamivudine/Zidovudine|
16388962|NCT00028327|Drug|Nelfinavir mesylate|
16388963|NCT00028327|Drug|Efavirenz|
16388964|NCT00028327|Drug|Lamivudine|
16388965|NCT00028327|Drug|Zidovudine|
16388966|NCT00028314|Drug|Abacavir sulfate|
16388967|NCT00028314|Drug|Atazanavir/Ritonavir|
16388968|NCT00028314|Drug|Lopinavir/Ritonavir|
16388969|NCT00028314|Drug|Nevirapine|
16388970|NCT00028301|Drug|Atazanavir|
16388971|NCT00028301|Drug|Lopinavir/Ritonavir|
16388972|NCT00028288|Drug|Daclizumab|
16388973|NCT00028275|Drug|Gamma Interferon 1b|
16388974|NCT00028262|Drug|Cystagon|
16388975|NCT00028236|Drug|Gene-Transduced Autologous CD34+ Stem Cells|
16388976|NCT00028171|Drug|Tacrolimus|
16388977|NCT00028158|Drug|G207, an oncolytic virus|
16388978|NCT00028145|Behavioral|Adherence assessment|Adherence will be assessed using questionnaires at all study visits.
16388979|NCT00028132|Drug|Tenofovir|
16388980|NCT00028106|Drug|[131]I-MIBG|
16388981|NCT00028106|Drug|6-[18F]Fluorodopamine|
16388982|NCT00028106|Drug|[123]I-MIBG|
16388983|NCT00028093|Drug|Peginterferon alfa-2a with Ribavirin|Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients <75 kg and 1200 mg daily for patients >=75 kg) for 48 weeks
16388984|NCT00028093|Drug|Peginterferon alfa-2a|Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
16388985|NCT00028067|Drug|Atazanavir|
16388986|NCT00028067|Drug|Nelfinavir mesylate|
16388987|NCT00027469|Procedure|MRI|
16388988|NCT00027456|Drug|Leptin A-100|
16388989|NCT00027443|Drug|Muromonab-CD3|
16388990|NCT00027443|Drug|Cyclosporine|
16388991|NCT00027430|Drug|TheraDerm|
16388992|NCT00027417|Drug|Liothyronine sodium/triiodothyronine|
16388993|NCT00027417|Procedure|Cardiopulmonary bypass and cardiac surgery|
16388994|NCT00027404|Drug|Fluoxetine|
16388995|NCT00027391|Drug|Albuterol|
16388996|NCT00027391|Drug|Oxandrolone|
16388997|NCT00027378|Drug|fluoxetine (Prozac)|fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up
16388998|NCT00027378|Drug|Placebo plus Treatment As Usual|placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up
16388999|NCT00027365|Biological|Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A|
16389000|NCT00027365|Biological|NefTat|
16389001|NCT00027365|Drug|AS02A Adjuvant|
16389002|NCT00027365|Biological|gp120W61D|
16389003|NCT00027339|Drug|lopinavir/ritonavir|
16389004|NCT00027339|Drug|indinavir sulfate|
16389005|NCT00027339|Drug|tenofovir disoproxil fumarate|
16389006|NCT00027339|Drug|ritonavir|
16389007|NCT00027339|Drug|fosamprenavir|
16389008|NCT00027300|Drug|Natalizumab|Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
16389009|NCT00027300|Drug|Placebo|Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
16389010|NCT00027287|Drug|Vitamin E|
16389011|NCT00027261|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389012|NCT00027248|Drug|MBI 226|
16389013|NCT00027209|Drug|prempro|
16389014|NCT00027170|Device|Siemens MRI scanner|Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
16389015|NCT00027144|Biological|Heat Shock Protein 70 HSP70|
16389016|NCT00027131|Biological|Heat Shock Protein 70-peptide complexes (HSP70)|
16389017|NCT00027079|Drug|ondansetron (Zofran)|
16389018|NCT00027079|Drug|naltrexone (ReVia)|
16389019|NCT00027079|Behavioral|Cognitive Behavioral Therapy|
16389020|NCT00027066|Drug|Active Aspirin|325mg tablet daily
16389021|NCT00027066|Drug|Active Warfarin|2mg scored tablet daily
16389022|NCT00027066|Drug|Aspirin placebo|325mg aspirin placebo pill
16389023|NCT00027066|Drug|Warfarin placebo|2mg scored placebo tablet
16389024|NCT00027053|Drug|Trazodone|50 to 150 mg qhs
16389025|NCT00027053|Drug|Placebo|
16389026|NCT00027040|Drug|Selegiline hydrochloride|
16389027|NCT00027027|Drug|rhuMAb 2C4|
16389028|NCT00027014|Drug|St. John's Wort|
16389029|NCT00027014|Drug|oxycodone|
16389030|NCT00027014|Drug|fentanyl|
16389031|NCT00027001|Behavioral|Aerobic and Resistance Exercises|
16389032|NCT00027001|Behavioral|Qigong|
16389033|NCT00026988|Drug|Creatine|
16389034|NCT00026975|Procedure|Hyperbaric Oxygen|
16389035|NCT00026962|Procedure|measuring estradiol and progesterone levels in saliva|
16389036|NCT00026936|Procedure|Radiotherapy|
16389037|NCT00026923|Procedure|Laparoscopic surgery|
16389038|NCT00026897|Procedure|Gamma-camera imaging|
16389039|NCT00026897|Procedure|Low-risk biopsy|
16389040|NCT00026871|Procedure|Radiotherapy|
16389041|NCT00026858|Behavioral|collaboration|
16389042|NCT00026819|Drug|Rofecoxib|
16389043|NCT00026637|Drug|sertraline|Sertraline: 25-200mg PO (orally); Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the CES-D, a questionnaire that is administered every 2 weeks over the 16 week intervention period. Subjects may reduce dosage if toxicity occurs.
16389044|NCT00026637|Behavioral|cognitive behavior therapy|CBT (Cognitive Behavior Therapy) - CBT is a psychotherapy based on modifying cognitions, assumptions, beliefs and behaviors, with the aim of influencing disturbed emotions. Subjects will meet with a trained CBT therapist for 1 hour each week over the 16 week intervention period and will be given assignments to work on each week.
16389045|NCT00026624|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389046|NCT00026624|Drug|Keyhole-Limpet Hemocyanin|
16389047|NCT00026611|Biological|Dryvax vaccine|
16389048|NCT00026585|Drug|Tamoxifen|
16389051|NCT00026065|Behavioral|Biofeedback|
16389052|NCT00026052|Drug|riluzole|
16389053|NCT00026039|Drug|estrogen|
16389054|NCT00026013|Drug|hypericum perforatum|
16389055|NCT00025987|Device|Head and Neck Cooling System|
16389056|NCT00025987|Device|Thermometer Pill|
16389057|NCT00025909|Procedure|Leukapheresis|
16389058|NCT00025896|Drug|recombinant human acid alpha-glucosidase (rhGAA)|
16389059|NCT00027222|Procedure|retinal ablation|
16389060|NCT00025818|Drug|Ophthalmic Emulsion|
16389061|NCT00025883|Drug|Metreleptin|Drug treatment
16389062|NCT00025805|Drug|G-CSF|
16389063|NCT00025792|Drug|Pramipexole|
16389064|NCT00025779|Drug|methylphenidate|
16389065|NCT00025779|Drug|guanfacine|
16389066|NCT00025766|Device|PCI with stenting|PCI with stenting of the occluded culprit infarct-related artery
16389067|NCT00025766|Behavioral|Optimal Medical Therapy|Participants will receive optimal medical therapy.
16389068|NCT00025753|Drug|rosiglitazone (Avandia)|
16389069|NCT00025753|Behavioral|Aerobic and weight lifting exercise training|
16389070|NCT00025740|Drug|clonazepam and paroxetine|
16389071|NCT00025727|Drug|Lopinavir/Ritonavir|
16389072|NCT00025727|Drug|Ritonavir|
16389073|NCT00025727|Drug|GW433908|
16389074|NCT00024986|Drug|Tenofovir DF|
16389075|NCT00024934|Drug|B-Lymphocyte Stimulator (BLyS)|
16389076|NCT00024687|Drug|SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin|
16389077|NCT00024674|Drug|SS1(dsFv)-PE38|
16389078|NCT00024661|Drug|LErafAON|
16389079|NCT00024648|Drug|LErafAON|
16389080|NCT00024570|Drug|IL13-PE38QQR|
16389081|NCT00024570|Procedure|targeted fusion protein therapy|
16389082|NCT00024570|Procedure|surgery|
16389083|NCT00024557|Drug|IL13-PE38QQR|
16389084|NCT00024557|Procedure|targeted fusion protein therapy|
16389085|NCT00024557|Procedure|surgery|
16389086|NCT00024544|Drug|anti-IL-4 monoclonal antibody (pascolizumab)|
16389087|NCT00024531|Drug|Atorvastatin calcium|
16389088|NCT00024518|Drug|30,000 units hrINF-alpha|
16389089|NCT00024518|Drug|5,000 hrINF-alpha|
16389090|NCT00024518|Other|Placebo|placebo was prepared as saline alone with 6mg human serum albumin (HSA).
16389091|NCT00024492|Drug|Liposome Encapsulated Mitoxantrone (LEM)|
16389092|NCT00023595|Procedure|CABG surgery plus MED|CABG plus standard medication management for Coronary Artery Disease
16389093|NCT00023595|Drug|Active Medication Alone|Standard medication for coronary artery disease and heart failure management.
16389094|NCT00023595|Procedure|CABG plus MED and SVR|H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
16389095|NCT00023504|Biological|Pneumovax|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
16389156|NCT00021671|Drug|Erythromycin|
16389157|NCT00021671|Drug|Nevirapine|
16389096|NCT00023504|Biological|Rabavert|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
16389097|NCT00023504|Biological|Prevnar|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
16389098|NCT00023504|Biological|Tetanus diphtheria toxoid|To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
16389099|NCT00023465|Procedure|FDG-PET|
16389100|NCT00023465|Procedure|spirometry|
16389101|NCT00023465|Procedure|bronchoscopy with BAL|
16389102|NCT00023452|Drug|RPT + INH once weekly for 3 months given by DOT|"Rifapentine (RPT) 900 mg once-weekly x 12 doses (3 months) for persons > 50.0 kg. For persons < 50.0 kg, the following doses will be given (Weight/Dose): 10.0-14.0 kg / 300 mg; 14.1-25.0 kg / 450 mg; 25.1-32.0 kg / 600 mg; 32.1-50.0 kg / 750 mg.
~PLUS
~Isoniazid (INH) 15 mg/kg (rounded up to nearest 50 or 100 mg; 900 mg max) once weekly x 12 doses if > 12 years old. INH 25 mg/kg (round up to nearest 50 or 100 mg; 900 mg max) if 2-11 years old.
~Therapy will be given by Directly Observed Therapy (DOT)."
16389103|NCT00023452|Drug|Isoniazid (INH) daily for 9 months|Isoniazid (INH) 5 mg/kg (rounded up to nearest 50 or 100 mg; 300 mg max) daily x 270 doses (9 months) For children age 2 - 11, INH 10-15 mg/kg (round up to nearest 50 or 100 mg; 300 mg max) will be given.
16389104|NCT00023439|Other|Nucleic Acid Amplification Methods for diagnosis|no intervention
16389105|NCT00023426|Drug|rifapentine|
16389106|NCT00023413|Drug|Rifabutin|
16389107|NCT00023413|Drug|Efavirenz|
16389108|NCT00023400|Drug|Nelfinavir|
16389109|NCT00023400|Drug|Rifabutin|
16389110|NCT00023387|Drug|Rifapentine|
16389111|NCT00023387|Drug|25-desacetyl Rifapentine|
16389112|NCT00023387|Drug|Isoniazid|
16389113|NCT00023374|Drug|Rifampin|6mos REZ intermittent
16389114|NCT00023374|Drug|Pyrazinamide|6mos REZ intermittent
16389115|NCT00023374|Drug|Ethambutol|6mos REZ intermittent
16389116|NCT00023374|Drug|REZ|Rif+PZA+EMB given 2 or 3 times weekly for 6 months
16389117|NCT00023361|Drug|Rifabutin|
16389118|NCT00023348|Drug|Isoniazid|
16389119|NCT00023348|Drug|Rifabutin|
16389120|NCT00023335|Drug|Rifapentine|
16389121|NCT00023335|Drug|Isoniazid|
16389122|NCT00023543|Behavioral|Diet, fat-restricted|Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
16389123|NCT00023543|Behavioral|Exercise|Rigorous, stepped care approach to reach 150 min/week of physical activity.
16389124|NCT00023530|Drug|fluconazole|
16389125|NCT00023530|Drug|voriconazole|
16389126|NCT00023530|Procedure|bone marrow transplant|
16389127|NCT00023530|Drug|thalidomide|
16389128|NCT00023530|Drug|dexamethasone|
16389129|NCT00023322|Drug|Peginterferon Alpha-2a|Treatment
16389130|NCT00023309|Drug|Lamivudine and adefovir|Lamivudine (100 mg/day) and adefovir (10 mg/day)
16389131|NCT00023309|Drug|Adefovir alone|Adefovir (10 mg/day)
16389132|NCT00023296|Drug|Nitric Oxide|
16389133|NCT00023296|Device|INO Pulse - NO Delivery System|
16389134|NCT00023283|Drug|Buprenorphine|"Experimental Standard Medical Management with once-weekly medication dispensing
~Experimental Standard Medical Management with thrice-weekly medication dispensing
~Experimental Enhanced Medical Management with thrice-weekly medication dispensing"
16389135|NCT00023244|Drug|Basiliximab|Administered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight.
16389136|NCT00023244|Drug|Cyclosporine|Participants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3).
16389137|NCT00023244|Drug|Tacrolimus|Participants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study.
16389138|NCT00023244|Drug|Sirolimus|Participants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study.
16389139|NCT00023244|Drug|Methylprednisolone|Administered at 10 mg/kg intravenously perioperatively and on postoperative day 1.
16389140|NCT00023244|Drug|Prednisone|Administered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180.
16389141|NCT00023244|Drug|Bactrim|All subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg).
16389142|NCT00023231|Drug|Daclizumab|1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8
16389143|NCT00023231|Drug|Methylprednisolone/prednisone|Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.
16389144|NCT00023231|Drug|Mycophenolate mofetil|Solution or oral tablet taken daily. Dosage depends on body surface area.
16389145|NCT00023231|Drug|Sirolimus|Oral tablet taken once prior to transplant. Dosage dependent on body surface area.
16389146|NCT00023231|Drug|Bactrim|Oral tablet taken three times per week. Dosage is dependent on weight.
16389147|NCT00023231|Drug|Ganciclovir|Oral tablet taken daily. Dosage is dependent on weight.
16389148|NCT00023231|Drug|Lipitor|Oral tablet taken daily
16389149|NCT00023218|Drug|Lopinavir/Ritonavir|
16389150|NCT00023218|Drug|Efavirenz|
16389151|NCT00023205|Behavioral|11th grade reading level arthritis materials|
16389152|NCT00023205|Behavioral|Interactive in-person arthritis education|
16389153|NCT00022763|Drug|Enfuvirtide|
16389154|NCT00021762|Biological|HIV-1 Immunogen|
16389155|NCT00021762|Procedure|Structured Treatment Interruption|
16389158|NCT00021671|Drug|Ampicillin sodium|
16389159|NCT00021671|Drug|Metronidazole|
16389160|NCT00021554|Drug|Enfuvirtide|
16389161|NCT00021489|Drug|Abacavir sulfate|
16389162|NCT00021489|Drug|Mycophenolate mofetil|
16389163|NCT00021463|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16389164|NCT00021463|Drug|Abacavir sulfate|
16389165|NCT00021463|Drug|Efavirenz|
16389166|NCT00021463|Drug|Nevirapine|
16389167|NCT00017992|Drug|Lopinavir/Ritonavir|
16389168|NCT00017992|Drug|Emtricitabine|
16389169|NCT00017992|Drug|Stavudine|
16389170|NCT00017784|Drug|Valganciclovir|
16389171|NCT00017758|Drug|Pravastatin sodium|
16389172|NCT00017758|Drug|Simvastatin|
16389173|NCT00017758|Drug|Atorvastatin calcium|
16389174|NCT00017758|Drug|Nelfinavir mesylate|
16389175|NCT00017758|Drug|Efavirenz|
16389176|NCT00017719|Drug|Lamivudine|
16389177|NCT00017719|Drug|Lamivudine/Zidovudine|
16389178|NCT00017719|Drug|Nelfinavir mesylate|
16389179|NCT00017719|Drug|Nevirapine|
16389180|NCT00017719|Drug|Zidovudine|
16389181|NCT00017693|Biological|Recombinant human soluble IL-4 receptor|Subjects were randomized to twelve once weekly nebulizations of 0.75, 1.5, or 3.0 mg dose of recombinant human soluble IL-4 receptor (rsIL-4R)
16389182|NCT00017693|Biological|Placebo for Recombinant human soluble IL-4 receptor|Subjects were randomized to twelve once weekly nebulizations of placebo for recombinant human soluble IL-4 receptor (rsIL-4R). Identically prepared (to the recombinant human soluble IL-4 receptor) in the same volume
16389183|NCT00016718|Drug|Didanosine (ddI)|Antiretroviral Didanosine (ddI) : 240 mg/m^2 up to a maximum of 400 mg once daily
16389184|NCT00016718|Drug|Efavirenz (EFV)|Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution
16389185|NCT00016718|Drug|Emtricitabine (FTC)|Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily
16389186|NCT00016692|Drug|Z-100|
16389187|NCT00016601|Drug|Indinavir sulfate|
16389188|NCT00016601|Drug|Ritonavir|
16389189|NCT00016601|Drug|Nelfinavir mesylate|
16389190|NCT00016601|Drug|Efavirenz|
16389191|NCT00016601|Drug|Nevirapine|
16389192|NCT00016601|Drug|Medroxyprogesterone acetate|
16389193|NCT00016588|Drug|Tenofovir disoproxil fumarate|
16389194|NCT00016536|Drug|Naphthalene 2-sulfonate polymer|
16389195|NCT00016536|Drug|Carbopol polymer|
16389196|NCT00015704|Drug|Aldesleukin|
16389197|NCT00015691|Drug|Metformin hydrochloride|
16389198|NCT00015691|Drug|Rosiglitazone maleate|
16389199|NCT00015652|Drug|Ribavirin|
16389200|NCT00015652|Drug|Aldesleukin|
16389201|NCT00015652|Drug|Peginterferon alfa-2b|
16389202|NCT00014937|Drug|lopinavir/ritonavir|
16389203|NCT00014937|Drug|lamivudine/zidovudine|
16389204|NCT00014937|Drug|efavirenz|
16389205|NCT00014937|Drug|lamivudine|
16389206|NCT00014937|Drug|stavudine|
16389207|NCT00014937|Drug|zidovudine|
16389208|NCT00014937|Drug|didanosine|
16389209|NCT00014911|Procedure|Islet Transplantation|Participants will receive portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. Up to three transplants are possible depending on individual results.
16389210|NCT00014911|Drug|Sirolimus|Administered at a dose of 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing will be adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
16389211|NCT00014911|Drug|Tacrolimus|Administered at a dose of 1 mg by mouth once pre-transplantation followed by 1 mg twice daily post transplantation. Levels will be adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
16389212|NCT00014911|Drug|Daclizumab|Administered at a dose of 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation, totaling 5 doses(over 8 weeks). Further daclizumab dosing may be necessary based on individual results and islet transplantation needs.
16389213|NCT00014911|Drug|Sulfamethoxazole|An antibacterial used to prevent opportunistic infections
16389214|NCT00014911|Drug|Ganciclovir|An antiviral used to kill viruses and stop viral replication
16389215|NCT00014911|Drug|Trimethoprim|An antibacterial used to prevent opportunistic infections
16389216|NCT00014911|Drug|Pentamidine|An antiprotozoal used to prevent disease
16389217|NCT00014014|Drug|Lamivudine/Zidovudine|
16389218|NCT00013897|Drug|Atazanavir|
16389219|NCT00013897|Drug|Lamivudine/Zidovudine|
16389220|NCT00013897|Drug|Efavirenz|
16389221|NCT00013871|Biological|Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed|
16389222|NCT00013871|Biological|Measles-Mumps-Rubella Vaccine (Live)|
16389223|NCT00013871|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
16389224|NCT00013871|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|
16389225|NCT00013871|Biological|Hepatitis B Vaccine (Recombinant)|
16389226|NCT00013663|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389227|NCT00013663|Drug|Aldesleukin|
16389228|NCT00013585|Drug|Selegiline hydrochloride|
16389229|NCT00013572|Biological|ALVAC-HIV MN120TMG (vCP205)|
16389230|NCT00013520|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16389231|NCT00013520|Drug|Atazanavir|
16389232|NCT00013520|Drug|Lamivudine/Zidovudine|
16389233|NCT00013520|Drug|Abacavir sulfate|
16389234|NCT00013520|Drug|Efavirenz|
16389235|NCT00013520|Drug|Nevirapine|
16389236|NCT00013520|Drug|Lamivudine|
16389237|NCT00013520|Drug|Stavudine|
16389238|NCT00013520|Drug|Zidovudine|
16389239|NCT00013520|Drug|Didanosine|
16389240|NCT00012519|Drug|indinavir sulfate|
16389241|NCT00012519|Drug|ritonavir|
16389242|NCT00012467|Drug|Itraconazole|
16389243|NCT00012467|Drug|Flucytosine|
16389244|NCT00012467|Drug|Fluconazole|
16389245|NCT00012467|Drug|Amphotericin B|
16389246|NCT00012467|Drug|Interferon gamma-1b|
16389247|NCT00011895|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16389248|NCT00011895|Drug|Efavirenz|
16389249|NCT00011479|Drug|Abacavir sulfate|
16389250|NCT00011128|Behavioral|Antiretroviral Treatment Interruption|
16389251|NCT00011089|Drug|Tenofovir disoproxil fumarate|
16389252|NCT00011037|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|1 x 10^ 7 TCID50 administered intramuscularly
16389253|NCT00011037|Biological|MN rgp120/HIV-1|0.6 mg administered intramuscularly
16389254|NCT00011037|Biological|ALVAC(2)120(B,MN)GNP (vCP1452) placebo|ALVAC placebo administered intramuscularly
16389255|NCT00011037|Biological|MN rgp120/HIV-1 placebo|Alum placebo administered intramuscularly
16389256|NCT00011011|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389257|NCT00009555|Drug|Testosterone|
16389258|NCT00009061|Drug|Ritonavir|
16389259|NCT00009061|Drug|Abacavir sulfate|
16389260|NCT00009061|Drug|Nelfinavir mesylate|
16389261|NCT00009061|Drug|Lamivudine|
16389262|NCT00009061|Drug|GW433908|
16389263|NCT00008866|Biological|Tetanus Toxoid Vaccine|
16389264|NCT00008866|Drug|Hydroxyurea|
16389265|NCT00008866|Drug|Didanosine|
16389266|NCT00008853|Biological|GBS III-TT-SSI|
16389267|NCT00008853|Biological|GBS III-TT-MPHL|
16389268|NCT00008554|Drug|Abacavir sulfate|
16389269|NCT00008554|Drug|Nelfinavir mesylate|
16389270|NCT00008554|Drug|Lamivudine|
16389271|NCT00008554|Drug|GW433908|
16389272|NCT00008528|Drug|Enfuvirtide|
16389273|NCT00008489|Drug|Didanosine|
16389274|NCT00008463|Drug|Ribavirin|
16389275|NCT00008463|Drug|Interferon alfa-2a|
16389276|NCT00008463|Drug|Peginterferon alfa-2a|
16389277|NCT00007787|Biological|Cyclosporine|
16389278|NCT00007787|Biological|Anti-human thymocyte globulin (rabbit)|Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5 mg/kg while undergoing transplantation. Second and subsequent doses of Thymoglobulin® will be administered if, at 24 hours post-anastomosis, the serum creatinine has not decreased by at least 20% from the pre-transplant level. Additional Anti-human thymocyte globulin (rabbit) will be given at a dose of 1.5mg/kg daily for a minimum of 5 days to a maximum of 7 days.
16389279|NCT00007787|Drug|Tacrolimus|
16389280|NCT00007449|Drug|DPC 083|
16389281|NCT00007436|Drug|Tenofovir disoproxil fumarate|
16389282|NCT00007423|Biological|ALVAC-HIV MN120TMG (vCP205)|
16389283|NCT00007423|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16389284|NCT00007332|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389285|NCT00007332|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
16389286|NCT00007202|Drug|Atazanavir|
16389287|NCT00007202|Drug|Stavudine|
16389288|NCT00007202|Drug|Didanosine|
16389289|NCT00006630|Drug|Vaccinia Immune Globulin (Human)|
16389290|NCT00006617|Drug|Abacavir sulfate|
16389291|NCT00006617|Drug|Amprenavir|
16389292|NCT00006617|Drug|Lamivudine|
16389293|NCT00006617|Drug|Zidovudine|
16389294|NCT00006604|Drug|ATV|Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.
16389295|NCT00006604|Drug|Ritonavir|Administered as 100 mg capsules or oral solution.
16389296|NCT00006591|Drug|Ritonavir|
16389297|NCT00006591|Drug|Amprenavir|
16389298|NCT00006578|Drug|Ritonavir|
16389299|NCT00006578|Drug|Abacavir sulfate|
16389300|NCT00006578|Drug|Amprenavir|
16389301|NCT00006578|Drug|Lamivudine|
16389302|NCT00006578|Drug|Filgrastim|
16389303|NCT00006509|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389304|NCT00006509|Biological|gp160 MN/LAI-2|
16389305|NCT00006495|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389306|NCT00006495|Biological|HIV-1 Immunogen|
16389307|NCT00006443|Drug|Indinavir sulfate|
16389308|NCT00006443|Drug|Nelfinavir mesylate|
16389309|NCT00006443|Drug|Lamivudine|
16389310|NCT00006443|Drug|Stavudine|
16389311|NCT00006441|Drug|Lamivudine/Zidovudine|300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.
16389312|NCT00006441|Drug|Nelfinavir mesylate|1250 mg twice daily for 104 weeks.
16389313|NCT00006441|Drug|Aldesleukin|7.5 million units twice daily. Treatment will last until conclusion of study.
16389314|NCT00006412|Drug|Pravastatin sodium|
16389315|NCT00006412|Drug|Fenofibrate|
16389316|NCT00006397|Drug|Indinavir sulfate|
16389317|NCT00006397|Drug|Ritonavir|
16389318|NCT00006397|Drug|Stavudine|
16389319|NCT00006397|Drug|Didanosine|
16389320|NCT00006396|Drug|Nevirapine|
16389321|NCT00006396|Drug|Zidovudine|
16389322|NCT00006339|Drug|Indinavir sulfate|
16389323|NCT00006339|Drug|Ritonavir|
16389324|NCT00006339|Drug|Hydroxyurea|
16389325|NCT00006339|Drug|Stavudine|
16389326|NCT00006339|Drug|Didanosine|
16389327|NCT00006327|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
16389328|NCT00006326|Drug|Indinavir sulfate|
16389329|NCT00006326|Drug|Ritonavir|
16389330|NCT00006326|Drug|Delavirdine mesylate|
16389331|NCT00006325|Drug|Peginterferon alfa-2b|
16389332|NCT00006324|Drug|Ethinyl estradiol/levonorgestrel|
16389333|NCT00006324|Drug|Medroxyprogesterone acetate|
16389334|NCT00006291|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389335|NCT00006291|Drug|Aldesleukin|
16389336|NCT00006279|Drug|Nevirapine|
16389337|NCT00006211|Drug|Capravirine|
16389338|NCT00006211|Drug|Nelfinavir mesylate|
16389339|NCT00006209|Drug|Tucaresol|
16389340|NCT00006208|Drug|Efavirenz|
16389341|NCT00006208|Drug|Emtricitabine|
16389342|NCT00006208|Drug|Stavudine|
16389343|NCT00006208|Drug|Didanosine|
16389344|NCT00006207|Drug|PRO 2000|
16389345|NCT00006154|Drug|Indinavir sulfate|400 mg tablets equaling 1600 mg daily
16389346|NCT00006154|Drug|Ritonavir|100 mg liquid capsules equaling 400 mg daily
16389347|NCT00006154|Drug|Abacavir sulfate|300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks.
16389348|NCT00006154|Drug|Efavirenz|200 mg capsules equaling 600 mg daily
16389349|NCT00006154|Drug|Stavudine|30-40 mg capsules equaling 60 or 80 mg daily
16389350|NCT00006154|Drug|Didanosine|250-400 mg E.coated tablets equaling 250 or 400 mg daily
16389351|NCT00006154|Drug|Aldesleukin|Subcutaneous injection equaling 15 x 10^6 IU daily dose. Administration based on individual results after 16 weeks and randomization.
16389352|NCT00006153|Biological|HIV-1 Immunogen|
16389353|NCT00006152|Drug|Ritonavir|
16389354|NCT00006152|Drug|Abacavir sulfate|
16389355|NCT00006152|Drug|Amprenavir|
16389356|NCT00006146|Biological|Approved influenza virus vaccine.|
16389357|NCT00006145|Drug|Valganciclovir|
16389358|NCT00006144|Drug|Lopinavir/Ritonavir|
16389359|NCT00006144|Drug|Emtricitabine|
16389360|NCT00006144|Drug|Stavudine|
16389361|NCT00006143|Drug|Somatropin|
16389362|NCT00006075|Drug|Chlorhexidine gluconate|
16389363|NCT00006066|Biological|Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed|
16389364|NCT00006066|Biological|Diphtheria and Tetanus Toxoids Adsorbed|
16389365|NCT00006066|Biological|Tetanus and Diphtheria Toxoids Adsorbed|
16389366|NCT00006066|Drug|Bacteriophage phi X 174|
16389367|NCT00006066|Drug|Aldesleukin|
16389368|NCT00005931|Drug|SU5416|
16389369|NCT00005921|Drug|L-743,872|
16389370|NCT00005920|Drug|L-743,872|
16389371|NCT00005918|Drug|Efavirenz|
16389372|NCT00005918|Drug|Lamivudine|
16389373|NCT00005918|Drug|Stavudine|
16389374|NCT00005779|Drug|Interleukin-12|
16389375|NCT00005779|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
16389376|NCT00005764|Drug|Lamivudine/Zidovudine|
16389377|NCT00005764|Drug|Abacavir sulfate|
16389378|NCT00005764|Drug|Lamivudine|
16389379|NCT00005762|Drug|Indinavir sulfate|
16389380|NCT00005762|Drug|Ritonavir|
16389381|NCT00005762|Drug|Amprenavir|
16389382|NCT00005762|Drug|Nelfinavir mesylate|
16389383|NCT00005762|Drug|Efavirenz|
16389384|NCT00005762|Drug|Saquinavir|
16389385|NCT00005758|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16389386|NCT00005758|Biological|HIV-1 Immunogen|
16389387|NCT00005668|Drug|Itraconazole oral solution|
16389388|NCT00005663|Drug|Valacyclovir hydrochloride|
16389389|NCT00005120|Drug|Calanolide A|
16389390|NCT00005118|Drug|Indinavir sulfate|
16389391|NCT00005118|Drug|Ritonavir|
16389392|NCT00005113|Drug|Cyclosporine|Oral tablet taken daily. Dosage is dependent on weight and is titrated to target trough level.
16389393|NCT00005113|Drug|Sirolimus|Dosage in liquid or tablet form is dependent on body surface area and is titrated to target trough level.
16389394|NCT00005113|Drug|Tacrolimus|dosage is in oral form titrated to target trough level
16389395|NCT00005106|Drug|Lamivudine/Zidovudine|
16389396|NCT00005106|Drug|Abacavir sulfate|
16389397|NCT00005106|Drug|Nelfinavir mesylate|
16389398|NCT00005106|Drug|Lamivudine|
16389399|NCT00005106|Drug|Stavudine|
16389400|NCT00005018|Drug|Hydroxyurea|
16389401|NCT00005018|Drug|Abacavir sulfate|
16389402|NCT00005018|Drug|Efavirenz|
16389403|NCT00005018|Drug|Didanosine|
16389404|NCT00005017|Drug|Ritonavir|
16389405|NCT00005017|Drug|Abacavir sulfate|
16389406|NCT00005017|Drug|Amprenavir|
16389407|NCT00005017|Drug|Efavirenz|
16389408|NCT00005017|Drug|Lamivudine|
16389409|NCT00005017|Drug|Stavudine|
16389410|NCT00005012|Drug|Peginterferon alfa-2b|
16389411|NCT00005010|Drug|Irbesartan|
16389412|NCT00005010|Drug|Pravastatin|
16389413|NCT00005009|Biological|Varivax®|Each participant will receive 2 doses of Varivax 6 to 8 weeks apart.
16389414|NCT00005002|Drug|Lamivudine/Zidovudine|
16389415|NCT00005002|Biological|HIV-1 Immunogen|
16389416|NCT00005002|Drug|Nelfinavir mesylate|
16389417|NCT00005001|Biological|HIV-1 Immunogen|
16389418|NCT00005000|Drug|Nelfinavir mesylate|
16389419|NCT00005000|Drug|Efavirenz|
16389420|NCT00005000|Drug|Lamivudine|
16389421|NCT00005000|Drug|Keyhole-Limpet Hemocyanin|
16389422|NCT00005000|Drug|Stavudine|
16389423|NCT00005000|Drug|Zidovudine|
16389424|NCT00005000|Drug|Didanosine|
16389425|NCT00004999|Drug|Lamivudine/Zidovudine|
16389426|NCT00004999|Drug|Capravirine|
16389427|NCT00004999|Drug|Nelfinavir mesylate|
16389428|NCT00004998|Drug|Lamivudine/Zidovudine|
16389429|NCT00004998|Drug|Capravirine|
16389430|NCT00004998|Drug|Nelfinavir mesylate|
16389431|NCT00004987|Drug|Dextrin 2-sulfate|
16389432|NCT00004986|Drug|Nitazoxanide|
16389433|NCT00004985|Drug|Capravirine|
16389434|NCT00004985|Drug|Nelfinavir mesylate|
16389435|NCT00004981|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16389436|NCT00004981|Drug|Lamivudine/Zidovudine|
16389437|NCT00004981|Drug|Abacavir sulfate|
16389438|NCT00004978|Drug|Recombinant interleukin-2 (rIL-2)|Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.
16389439|NCT00004855|Drug|Lopinavir/Ritonavir|
16389440|NCT00004855|Drug|Abacavir sulfate|
16389441|NCT00004855|Drug|Nevirapine|
16389442|NCT00004855|Drug|Lamivudine|
16389443|NCT00004855|Drug|Stavudine|
16389444|NCT00004852|Drug|Efavirenz|
16389445|NCT00004852|Drug|Lamivudine|
16389446|NCT00004852|Drug|Zidovudine|
16389447|NCT00004736|Drug|Nelfinavir mesylate|
16389448|NCT00004736|Drug|Ethambutol hydrochloride|
16389449|NCT00004736|Drug|Isoniazid|
16389450|NCT00004736|Drug|Pyrazinamide|
16389451|NCT00004736|Drug|Lamivudine|
16389452|NCT00004736|Drug|Rifabutin|
16389453|NCT00004736|Drug|Stavudine|
16389454|NCT00004736|Drug|Zidovudine|
16389455|NCT00004735|Biological|Tetanus toxoid|
16389456|NCT00004735|Biological|Hepatitis A Vaccine (Inactivated)|
16389457|NCT00004585|Drug|Abacavir sulfate, Lamivudine and Zidovudine|
16389458|NCT00004585|Drug|Lamivudine/Zidovudine|
16389459|NCT00004585|Drug|Abacavir sulfate|
16389460|NCT00004585|Drug|Efavirenz|
16389461|NCT00004584|Drug|Atazanavir|
16389462|NCT00004584|Drug|Ritonavir|
16389463|NCT00004584|Drug|Saquinavir|
16389464|NCT00004583|Drug|Lopinavir/Ritonavir|
16389465|NCT00004583|Drug|Nelfinavir mesylate|
16389466|NCT00004583|Drug|Lamivudine|
16389467|NCT00004583|Drug|Stavudine|
16389468|NCT00004582|Drug|Lopinavir/Ritonavir|
16389469|NCT00004582|Drug|Efavirenz|
16389470|NCT00004581|Drug|Lopinavir/Ritonavir|
16389471|NCT00004581|Drug|Nevirapine|
16389472|NCT00004580|Drug|Lopinavir/Ritonavir|
16389473|NCT00004580|Drug|Nevirapine|
16389474|NCT00004579|Biological|gp160 MN/LAI-2|
16389475|NCT00004579|Biological|ALVAC-HIV MN120TMG (vCP205)|
16389476|NCT00004578|Drug|Lopinavir/Ritonavir|Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
16389477|NCT00004578|Drug|Lamivudine|150 mg, every 12 hours
16389478|NCT00004578|Drug|Stavudine|40 mg every 12 hours
16389479|NCT00002453|Drug|Tenofovir disoproxil fumarate|
16389480|NCT00002452|Drug|L-756423|
16389481|NCT00002452|Drug|Indinavir sulfate|
16389482|NCT00002451|Drug|Indinavir sulfate|
16389483|NCT00002451|Drug|Ritonavir|
16389484|NCT00002451|Drug|Lamivudine|
16389485|NCT00002451|Drug|Stavudine|
16389486|NCT00002450|Drug|Tenofovir disoproxil fumarate|
16389487|NCT00002449|Drug|Aldesleukin|
16389488|NCT00002448|Drug|Ritonavir|
16389489|NCT00002448|Drug|Efavirenz|
16389490|NCT00002448|Drug|Saquinavir|
16389491|NCT00002447|Drug|Ritonavir|
16389492|NCT00002447|Drug|Efavirenz|
16389493|NCT00002447|Drug|Saquinavir|
16389494|NCT00002446|Drug|Posaconazole|
16389495|NCT00002446|Drug|Fluconazole|
16389496|NCT00002445|Drug|IM862|
16389497|NCT00002444|Drug|Nitazoxanide|
16389498|NCT00002443|Drug|Indinavir sulfate|
16389499|NCT00002443|Drug|Zidovudine|
16389500|NCT00002442|Drug|Indinavir sulfate|
16389501|NCT00002442|Drug|Nelfinavir mesylate|
16389502|NCT00002442|Drug|Lamivudine|
16389503|NCT00002442|Drug|Stavudine|
16389504|NCT00002441|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
16389505|NCT00002440|Drug|Indinavir sulfate|
16389506|NCT00002440|Drug|Ritonavir|
16389507|NCT00002440|Drug|Abacavir sulfate|
16389508|NCT00002440|Drug|Amprenavir|
16389509|NCT00002440|Drug|Nelfinavir mesylate|
16389510|NCT00002440|Drug|Saquinavir|
16389511|NCT00002439|Drug|Alitretinoin|
16389512|NCT00002438|Drug|Itraconazole|
16389513|NCT00002437|Drug|Cidofovir|
16389514|NCT00002437|Drug|Probenecid|
16389515|NCT00002436|Drug|Lamivudine|
16389516|NCT00002436|Drug|Zidovudine|
16389517|NCT00002436|Drug|Zalcitabine|
16389518|NCT00002435|Drug|Thymic Humoral Factor|
16389519|NCT00002435|Drug|Zidovudine|
16389520|NCT00002434|Drug|Trimetrexate glucuronate|
16389521|NCT00002434|Drug|Leucovorin calcium|
16389522|NCT00002433|Drug|Interferon gamma-1b|
16389523|NCT00002432|Drug|Foscarnet sodium|
16389524|NCT00002431|Drug|Chlorhexidine gluconate|
16389525|NCT00002430|Drug|Indinavir sulfate|
16389526|NCT00002430|Drug|Nelfinavir mesylate|
16389527|NCT00002430|Drug|Lamivudine|
16389528|NCT00002430|Drug|Stavudine|
16389529|NCT00002429|Drug|Lamivudine/Zidovudine|
16389530|NCT00002429|Drug|Nelfinavir mesylate|
16389531|NCT00002429|Drug|Stavudine|
16389532|NCT00002429|Drug|Didanosine|
16389533|NCT00002428|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
16389534|NCT00002428|Biological|rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine|
16389535|NCT00002427|Drug|Hydroxyurea|
16389536|NCT00002427|Drug|Stavudine|
16389537|NCT00002427|Drug|Didanosine|
16389538|NCT00002426|Drug|Adefovir dipivoxil|
16389539|NCT00002425|Drug|Saquinavir|
16389540|NCT00002424|Drug|L-756423|
16389541|NCT00002424|Drug|Indinavir sulfate|
16389542|NCT00002424|Drug|Lamivudine|
16389543|NCT00002424|Drug|Stavudine|
16389544|NCT00002423|Drug|Indinavir sulfate|
16389545|NCT00002423|Drug|Abacavir sulfate|
16389546|NCT00002423|Drug|Amprenavir|
16389547|NCT00002423|Drug|Nelfinavir mesylate|
16389548|NCT00002423|Drug|Lamivudine|
16389549|NCT00002422|Drug|HE2000|
16389550|NCT00002420|Drug|Emivirine|
16389551|NCT00002420|Drug|Hydroxyurea|
16389552|NCT00002420|Drug|Delavirdine mesylate|
16389553|NCT00002420|Drug|Stavudine|
16389554|NCT00002420|Drug|Didanosine|
16389555|NCT00002419|Drug|Abacavir sulfate|
16389556|NCT00002419|Drug|Amprenavir|
16389557|NCT00002419|Drug|Efavirenz|
16389558|NCT00002419|Drug|Adefovir dipivoxil|
16389559|NCT00002418|Drug|Emivirine|
16389560|NCT00002418|Drug|Hydroxyurea|
16389561|NCT00002418|Drug|Nevirapine|
16389562|NCT00002418|Drug|Stavudine|
16389563|NCT00002418|Drug|Didanosine|
16389564|NCT00002417|Drug|Amprenavir|
16389565|NCT00002416|Drug|Emtricitabine|
16389566|NCT00002416|Drug|Lamivudine|
16389567|NCT00002415|Drug|Tenofovir disoproxil fumarate|
16389568|NCT00002414|Drug|CPI-1189|
16389569|NCT00002413|Drug|Emivirine|
16389570|NCT00002412|Drug|Emivirine|
16389571|NCT00002412|Drug|Hydroxyurea|
16389572|NCT00002412|Drug|Stavudine|
16389573|NCT00002412|Drug|Didanosine|
16389574|NCT00002411|Drug|Nelfinavir mesylate|
16389575|NCT00002411|Drug|Lamivudine|
16389576|NCT00002411|Drug|Stavudine|
16389577|NCT00002411|Drug|Zidovudine|
16389578|NCT00002411|Drug|Didanosine|
16389579|NCT00002410|Drug|Indinavir sulfate|
16389580|NCT00002410|Drug|Lamivudine|
16389581|NCT00002410|Drug|Zidovudine|
16389582|NCT00002409|Drug|Lamivudine/Zidovudine|
16389583|NCT00002409|Drug|Abacavir sulfate|
16389584|NCT00002408|Drug|Crofelemer|
16389585|NCT00002407|Drug|Indinavir sulfate|
16389586|NCT00002407|Drug|Nevirapine|
16389587|NCT00002407|Drug|Lamivudine|
16389588|NCT00002407|Drug|Stavudine|
16389589|NCT00002407|Drug|Didanosine|
16389590|NCT00002406|Drug|Indinavir sulfate|
16389591|NCT00002405|Drug|Amprenavir|
16389592|NCT00002404|Drug|Valacyclovir hydrochloride|
16389593|NCT00002403|Drug|Zintevir|
16389594|NCT00002402|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
16389595|NCT00002402|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
16389596|NCT00002402|Biological|Aluminum hydroxide|
16389597|NCT00002401|Drug|Indinavir sulfate|
16389598|NCT00002401|Drug|Delavirdine mesylate|
16389599|NCT00002401|Drug|Lamivudine|
16389600|NCT00002401|Drug|Zidovudine|
16389601|NCT00002400|Drug|Indinavir sulfate|
16389602|NCT00002400|Drug|Delavirdine mesylate|
16389603|NCT00002400|Drug|Lamivudine|
16389604|NCT00002400|Drug|Zidovudine|
16389605|NCT00002399|Drug|Posaconazole|
16389606|NCT00002399|Drug|Fluconazole|
16389607|NCT00002398|Drug|Levocarnitine|
16389608|NCT00002398|Drug|Adefovir dipivoxil|
16389609|NCT00002397|Drug|Nelfinavir mesylate|
16389610|NCT00002397|Drug|Saquinavir|
16389611|NCT00002397|Drug|Lamivudine|
16389612|NCT00002397|Drug|Stavudine|
16389613|NCT00002396|Drug|Tenofovir disoproxil fumarate|
16389614|NCT00002395|Drug|Topotecan|
16389615|NCT00002394|Drug|Terbinafine hydrochloride|
16389616|NCT00002393|Drug|Indinavir sulfate|
16389617|NCT00002393|Drug|Efavirenz|
16389618|NCT00002392|Drug|Thalidomide|
16389619|NCT00002391|Drug|Abacavir sulfate|
16389620|NCT00002391|Drug|Lamivudine|
16389621|NCT00002391|Drug|Zidovudine|
16389622|NCT00002390|Drug|Abacavir sulfate|
16389623|NCT00002389|Drug|Abacavir sulfate|
16389624|NCT00002389|Drug|Lamivudine|
16389625|NCT00002389|Drug|Zidovudine|
16389626|NCT00002388|Drug|Abacavir sulfate|
16389627|NCT00002387|Drug|Indinavir sulfate|
16389628|NCT00002387|Drug|Efavirenz|
16389629|NCT00002386|Drug|Indinavir sulfate|
16389630|NCT00002386|Drug|Lamivudine|
16389631|NCT00002386|Drug|Stavudine|
16389632|NCT00002386|Drug|Zidovudine|
16389633|NCT00002386|Drug|Zalcitabine|
16389634|NCT00002386|Drug|Didanosine|
16389635|NCT00002385|Drug|Fozivudine tidoxil|
16389636|NCT00002384|Drug|Cidofovir|
16389637|NCT00002383|Drug|Saquinavir|
16389638|NCT00002382|Drug|Saquinavir|
16389639|NCT00002381|Drug|Nelfinavir mesylate|
16389640|NCT00002381|Drug|Nevirapine|
16389641|NCT00002381|Drug|Stavudine|
16389642|NCT00002380|Drug|Nelfinavir mesylate|
16389643|NCT00002380|Drug|Saquinavir|
16389644|NCT00002379|Drug|Indinavir sulfate|
16389645|NCT00002379|Drug|Levocarnitine|
16389646|NCT00002379|Drug|Adefovir dipivoxil|
16389647|NCT00002379|Drug|Lamivudine|
16389648|NCT00002379|Drug|Stavudine|
16389649|NCT00002379|Drug|Zidovudine|
16389650|NCT00002378|Drug|Ritonavir|
16389651|NCT00002378|Drug|Nelfinavir mesylate|
16389652|NCT00002378|Drug|Saquinavir|
16389653|NCT00002378|Drug|Delavirdine mesylate|
16389654|NCT00002378|Drug|Lamivudine|
16389655|NCT00002378|Drug|Stavudine|
16389656|NCT00002378|Drug|Zidovudine|
16389657|NCT00002377|Drug|Valganciclovir|
16389658|NCT00002377|Drug|Ganciclovir|
16389659|NCT00002376|Drug|Indinavir sulfate|
16389660|NCT00002376|Drug|Lamivudine|
16389661|NCT00002376|Drug|Stavudine|
16389662|NCT00002376|Drug|Zidovudine|
16389663|NCT00002376|Drug|Didanosine|
16389664|NCT00002375|Drug|Indinavir sulfate|
16389665|NCT00002375|Drug|Nelfinavir mesylate|
16389666|NCT00002374|Drug|Ritonavir|
16389667|NCT00002374|Drug|Nelfinavir mesylate|
16389668|NCT00002374|Drug|Saquinavir|
16389669|NCT00002374|Drug|Stavudine|
16389670|NCT00002373|Drug|Maribavir|
16389671|NCT00002372|Drug|Indinavir sulfate|
16389672|NCT00002372|Drug|Amprenavir|
16389673|NCT00002372|Drug|Nelfinavir mesylate|
16389674|NCT00002372|Drug|Saquinavir|
16389675|NCT00002371|Drug|Indinavir sulfate|
16389676|NCT00002371|Drug|Lamivudine|
16389677|NCT00002371|Drug|Stavudine|
16389678|NCT00002371|Drug|Zidovudine|
16389679|NCT00002370|Drug|Itraconazole|
16389680|NCT00002369|Drug|Indinavir sulfate|
16389681|NCT00002369|Drug|Lamivudine|
16389682|NCT00002369|Drug|Stavudine|
16389683|NCT00002369|Drug|Zidovudine|
16389684|NCT00002368|Drug|Nevirapine|
16389685|NCT00002368|Drug|Lamivudine|
16389686|NCT00002367|Drug|Saquinavir|
16389687|NCT00002367|Drug|Lamivudine|
16389688|NCT00002367|Drug|Zidovudine|
16389689|NCT00002366|Drug|Ritonavir|
16389690|NCT00002365|Drug|LXR015-1|
16389691|NCT00002364|Drug|Abacavir sulfate|
16389692|NCT00002363|Drug|Peptide Construction 3, Synthetic|
16389693|NCT00002362|Drug|Abacavir sulfate|
16389694|NCT00002362|Drug|Efavirenz|
16389695|NCT00002362|Drug|Emtricitabine|
16389696|NCT00002362|Drug|Stavudine|
16389697|NCT00002361|Drug|Indinavir sulfate|
16389698|NCT00002361|Drug|Ritonavir|
16389699|NCT00002360|Drug|Didanosine|
16389700|NCT00002359|Biological|HIV-1 Immunogen|
16389701|NCT00002358|Drug|Sorivudine|
16389702|NCT00002357|Drug|HBY 097|
16389703|NCT00002357|Drug|Zidovudine|
16389704|NCT00002356|Drug|Fomivirsen sodium|
16389705|NCT00002355|Drug|Fomivirsen sodium|
16389706|NCT00002354|Drug|Indinavir sulfate|
16389707|NCT00002354|Drug|Stavudine|
16389708|NCT00002353|Biological|P3C541b Lipopeptide|
16389709|NCT00002352|Drug|Lobucavir|
16389710|NCT00002351|Drug|Indinavir sulfate|
16389711|NCT00002350|Biological|APL 400-003|
16389712|NCT00002349|Drug|Stavudine|
16389713|NCT00002348|Drug|Mitoguazone|
16389714|NCT00002347|Drug|Saquinavir|
16389715|NCT00002347|Drug|Nevirapine|
16389716|NCT00002347|Drug|Zidovudine|
16389717|NCT00002347|Drug|Zalcitabine|
16389718|NCT00002346|Drug|Adefovir dipivoxil|
16389719|NCT00002345|Drug|Megestrol acetate|
16389720|NCT00002344|Drug|Azithromycin|
16389721|NCT00002343|Drug|Ethambutol hydrochloride|
16389722|NCT00002343|Drug|Rifabutin|
16389723|NCT00002342|Drug|Tecogalan sodium|
16389724|NCT00002341|Drug|Itraconazole|
16389725|NCT00002340|Drug|Atovaquone|
16389726|NCT00002340|Drug|Pentamidine isethionate|
16389727|NCT00002339|Drug|Fluconazole|
16389728|NCT00002338|Drug|Raluridine|
16389729|NCT00002337|Drug|Vesnarinone|
16389730|NCT00002336|Drug|Clarithromycin|
16389731|NCT00002335|Drug|Emtricitabine|
16389732|NCT00002334|Drug|Saquinavir|
16389733|NCT00002334|Drug|Zidovudine|
16389734|NCT00002334|Drug|Zalcitabine|
16389735|NCT00002333|Drug|Saquinavir|
16389736|NCT00002333|Drug|Zalcitabine|
16389737|NCT00002332|Drug|Thymopentin|
16389738|NCT00002331|Drug|Ethambutol hydrochloride|
16389739|NCT00002331|Drug|Clarithromycin|
16389740|NCT00002331|Drug|Clofazimine|
16389741|NCT00002330|Drug|Ganciclovir|
16389742|NCT00002329|Drug|Celgosivir hydrochloride|
16389743|NCT00002328|Drug|Azithromycin|
16389744|NCT00002327|Drug|Cidofovir|
16389745|NCT00002326|Drug|Adefovir|
16389746|NCT00002326|Drug|Zidovudine|
16389747|NCT00002325|Drug|Fluconazole|
16389748|NCT00002324|Drug|Nevirapine|
16389749|NCT00002324|Drug|Zidovudine|
16389750|NCT00002323|Drug|Nevirapine|
16389751|NCT00002323|Drug|Zidovudine|
16389752|NCT00002322|Drug|Atevirdine mesylate|
16389753|NCT00002322|Drug|Zidovudine|
16389754|NCT00002321|Drug|Aldesleukin|
16389755|NCT00002320|Drug|Lamivudine|
16389756|NCT00002320|Drug|Zidovudine|
16389757|NCT00002319|Drug|Doxorubicin hydrochloride (liposomal)|
16389758|NCT00002318|Drug|Doxorubicin hydrochloride (liposomal)|
16389759|NCT00002318|Drug|Bleomycin sulfate|
16389760|NCT00002318|Drug|Vincristine sulfate|
16389761|NCT00002318|Drug|Doxorubicin hydrochloride|
16389762|NCT00002317|Drug|Trimetrexate glucuronate|
16389763|NCT00002317|Drug|Leucovorin calcium|
16389764|NCT00002316|Drug|Lobradimil|
16389765|NCT00002316|Drug|Amphotericin B|
16389766|NCT00002315|Drug|Netivudine|
16389767|NCT00002315|Drug|Acyclovir|
16389768|NCT00002314|Drug|Ro 24-7429|
16389769|NCT00002313|Drug|Nystatin|
16389770|NCT00002313|Drug|Didanosine|
16389771|NCT00002312|Drug|Delavirdine mesylate|
16389772|NCT00002312|Drug|Zidovudine|
16389773|NCT00002311|Drug|Wobenzym|
16389774|NCT00002310|Drug|Crofelemer|
16389775|NCT00002309|Drug|Azithromycin|
16389776|NCT00002308|Drug|Stavudine|
16389777|NCT00002307|Drug|Stavudine|
16389778|NCT00002307|Drug|Zidovudine|
16389779|NCT00002306|Drug|Fluconazole|
16389780|NCT00002305|Drug|Flucytosine|
16389781|NCT00002305|Drug|Fluconazole|
16389782|NCT00002305|Drug|Amphotericin B|
16389783|NCT00002304|Drug|Ketoconazole|
16389784|NCT00002304|Drug|Fluconazole|
16389785|NCT00002303|Drug|Epoetin alfa|
16389786|NCT00002302|Drug|Epoetin alfa|
16389787|NCT00002301|Drug|Foscarnet sodium|
16389788|NCT00002300|Drug|Megestrol acetate|
16389789|NCT00002299|Drug|Interferon beta-1b|
16389790|NCT00002299|Drug|Ganciclovir|
16389791|NCT00002298|Drug|Ribavirin|
16389792|NCT00002297|Drug|Inosine pranobex|
16389793|NCT00002296|Drug|Inosine pranobex|
16389794|NCT00002295|Drug|Inosine pranobex|
16389795|NCT00002294|Drug|Fluconazole|
16389796|NCT00002293|Drug|Nystatin|
16389797|NCT00002292|Drug|Pentamidine isethionate|
16389798|NCT00002291|Drug|Pentamidine isethionate|
16389799|NCT00002290|Drug|Zidovudine|
16389800|NCT00002290|Drug|Acyclovir|
16389801|NCT00002289|Drug|Thymopentin|
16389802|NCT00002288|Drug|Zidovudine|
16389803|NCT00002287|Drug|Zidovudine|
16389804|NCT00002286|Drug|Zidovudine|
16389805|NCT00002285|Drug|Zidovudine|
16389806|NCT00002284|Drug|Zidovudine|
16389807|NCT00002283|Drug|Trimethoprim|
16389808|NCT00002283|Drug|Sulfamethoxazole|
16389809|NCT00002283|Drug|Dapsone|
16389810|NCT00002282|Drug|Clotrimazole|
16389811|NCT00002282|Drug|Fluconazole|
16389812|NCT00002281|Drug|Filgrastim|
16389813|NCT00002281|Drug|Epoetin alfa|
16389814|NCT00002281|Drug|Zidovudine|
16389815|NCT00002280|Drug|Didanosine|
16389816|NCT00002279|Drug|Zalcitabine|
16389817|NCT00002278|Drug|Diclazuril|
16389818|NCT00002277|Drug|Fluconazole|
16389819|NCT00002277|Drug|Amphotericin B|
16389820|NCT00002276|Drug|Ibuprofen|
16389821|NCT00002276|Drug|Zidovudine|
16389822|NCT00002275|Drug|Fat Emulsion 2%|
16389823|NCT00002275|Drug|Fat Emulsion 20%|
16389824|NCT00002274|Drug|Didanosine|
16389825|NCT00002273|Drug|Ganciclovir|
16389826|NCT00002272|Drug|Foscarnet sodium|
16389827|NCT00002271|Drug|Alovudine|
16389828|NCT00002270|Drug|Interferon alfa-2b|
16389829|NCT00002270|Drug|Zidovudine|
16389830|NCT00002269|Drug|Ampligen|
16389831|NCT00002269|Drug|Zidovudine|
16389832|NCT00002268|Drug|Sevirumab|
16389833|NCT00002267|Drug|Rifabutin|
16389834|NCT00002266|Drug|AS-101|
16389835|NCT00002265|Drug|Zalcitabine|
16389836|NCT00002264|Drug|Cryptosporidium Immune Whey Protein Concentrate (Bovine)|
16389837|NCT00002263|Drug|Zidovudine|
16389838|NCT00002263|Drug|Sargramostim|
16389839|NCT00002262|Drug|Tumor Necrosis Factor|
16389840|NCT00002261|Biological|Smallpox Vaccine|
16389841|NCT00002261|Biological|HIVAC-1e|
16389842|NCT00002261|Biological|gp160 Vaccine (MicroGeneSys)|
16389843|NCT00002260|Drug|Alovudine|
16389844|NCT00002259|Drug|Mitoxantrone hydrochloride|
16389845|NCT00002258|Drug|Interleukin-3|
16389846|NCT00002257|Drug|Ganciclovir|
16389847|NCT00002256|Drug|Zalcitabine|
16389848|NCT00002255|Drug|Filgrastim|
16389849|NCT00002255|Drug|Epoetin alfa|
16389850|NCT00002255|Drug|Zidovudine|
16389851|NCT00002254|Drug|Alovudine|
16389852|NCT00002253|Drug|Octreotide|
16389853|NCT00002252|Drug|Octreotide|
16389854|NCT00002251|Drug|Ganciclovir|
16389855|NCT00002250|Drug|CD4-IgG|
16389856|NCT00002249|Drug|Levofloxacin|
16389857|NCT00002248|Drug|Cryptosporidium Immune Whey Protein Concentrate (Bovine)|
16389858|NCT00002247|Drug|Ganciclovir|
16389859|NCT00002246|Drug|Stavudine|
16389860|NCT00002245|Drug|Abacavir sulfate|
16389861|NCT00002245|Drug|Amprenavir|
16389862|NCT00002245|Drug|Lamivudine|
16389863|NCT00002244|Drug|WF10|
16389864|NCT00002243|Drug|Calanolide A|
16389865|NCT00002241|Drug|Indinavir sulfate|
16389866|NCT00002241|Drug|Ritonavir|
16389867|NCT00002241|Drug|Lamivudine|
16389868|NCT00002241|Drug|Stavudine|
16389869|NCT00002240|Drug|Atazanavir|
16389870|NCT00002240|Drug|Nelfinavir mesylate|
16389871|NCT00002240|Drug|Stavudine|
16389872|NCT00002240|Drug|Didanosine|
16389873|NCT00002239|Drug|Enfuvirtide|
16389874|NCT00002239|Drug|Ritonavir|
16389875|NCT00002239|Drug|Abacavir sulfate|
16389876|NCT00002239|Drug|Amprenavir|
16389877|NCT00002239|Drug|Efavirenz|
16389878|NCT00002238|Drug|Interferon beta-1b|
16389879|NCT00002238|Drug|Zidovudine|
16389880|NCT00002237|Drug|Peldesine|
16389881|NCT00002236|Drug|Indinavir sulfate|
16389882|NCT00002236|Drug|Delavirdine mesylate|
16389883|NCT00002236|Drug|Zidovudine|
16389884|NCT00002235|Drug|Indinavir sulfate|
16389885|NCT00002235|Drug|Nelfinavir mesylate|
16389886|NCT00002235|Drug|Efavirenz|
16389887|NCT00002234|Drug|Efavirenz|
16389888|NCT00002234|Drug|Adefovir dipivoxil|
16389889|NCT00002234|Drug|Lamivudine|
16389890|NCT00002234|Drug|Didanosine|
16389891|NCT00002233|Drug|Indinavir sulfate|
16389892|NCT00002233|Drug|Abacavir sulfate|
16389893|NCT00002233|Drug|Amprenavir|
16389894|NCT00002233|Drug|Lamivudine|
16389895|NCT00002232|Biological|APL 400-003|
16389896|NCT00002231|Biological|APL 400-003|
16389897|NCT00002230|Drug|Hydroxyurea|
16389898|NCT00002230|Drug|Efavirenz|
16389899|NCT00002230|Drug|Stavudine|
16389900|NCT00002230|Drug|Didanosine|
16389901|NCT00002229|Drug|Saquinavir|
16389902|NCT00002228|Drug|Enfuvirtide|
16389903|NCT00002227|Drug|Efavirenz|
16389904|NCT00002227|Drug|Lamivudine|
16389905|NCT00002227|Drug|Stavudine|
16389906|NCT00002226|Drug|SU5416|
16389907|NCT00002225|Drug|Efavirenz|
16389908|NCT00002225|Drug|Stavudine|
16389909|NCT00002225|Drug|Didanosine|
16389910|NCT00002224|Drug|Nelfinavir mesylate|
16389911|NCT00002224|Drug|Stavudine|
16389912|NCT00002224|Drug|Didanosine|
16389913|NCT00002223|Drug|Indinavir sulfate|
16389914|NCT00002223|Drug|Ritonavir|
16389915|NCT00002222|Drug|Valganciclovir|
16389916|NCT00002221|Drug|Peripheral blood stem cells|
16389917|NCT00002220|Drug|Indinavir sulfate|
16389918|NCT00002220|Drug|Efavirenz|
16389919|NCT00002220|Drug|Levocarnitine|
16389920|NCT00002220|Drug|Adefovir dipivoxil|
16389921|NCT00002219|Drug|Nelfinavir mesylate|
16389922|NCT00002219|Drug|Levocarnitine|
16389923|NCT00002219|Drug|Adefovir dipivoxil|
16389924|NCT00002218|Drug|CI-1012|
16389925|NCT00002217|Drug|Lamivudine/Zidovudine|
16389926|NCT00002217|Drug|Abacavir sulfate|
16389927|NCT00002217|Drug|Amprenavir|
16389928|NCT00002216|Drug|Lamivudine/Zidovudine|
16389929|NCT00002216|Drug|Abacavir sulfate|
16389930|NCT00002216|Drug|Amprenavir|
16389931|NCT00002216|Drug|Nelfinavir mesylate|
16389932|NCT00002215|Drug|Emivirine|
16389933|NCT00002215|Drug|Nelfinavir mesylate|
16389934|NCT00002214|Drug|Capravirine|
16389935|NCT00002213|Drug|Abacavir sulfate|
16389936|NCT00002213|Drug|Amprenavir|
16389937|NCT00002213|Drug|Efavirenz|
16389938|NCT00002212|Drug|Bexarotene|
16389939|NCT00002211|Drug|Nelfinavir mesylate|
16389940|NCT00002211|Drug|Delavirdine mesylate|
16389941|NCT00002211|Drug|Stavudine|
16389942|NCT00002211|Drug|Didanosine|
16389943|NCT00002210|Drug|Delavirdine mesylate|
16389944|NCT00002209|Drug|CPI-1189|
16389945|NCT00002208|Drug|Indinavir sulfate|
16389946|NCT00002208|Drug|Lamivudine|
16389947|NCT00002208|Drug|Stavudine|
16389948|NCT00002208|Drug|Zidovudine|
16389949|NCT00002207|Drug|Stavudine|
16389950|NCT00002207|Drug|Didanosine|
16389951|NCT00002206|Drug|Adefovir dipivoxil|
16389952|NCT00002205|Drug|Abacavir sulfate|
16389953|NCT00002205|Drug|Amprenavir|
16389954|NCT00002204|Biological|HIV p24/MF59 Vaccine|
16389955|NCT00002203|Drug|Lamivudine/Zidovudine|
16389956|NCT00002203|Drug|Lamivudine|
16389957|NCT00002203|Drug|Zidovudine|
16389958|NCT00002202|Drug|Indinavir sulfate|
16389959|NCT00002202|Drug|Amprenavir|
16389960|NCT00002201|Drug|Ritonavir|
16389961|NCT00002201|Drug|Nelfinavir mesylate|
16389962|NCT00002200|Drug|Abacavir sulfate|
16389963|NCT00002199|Drug|Indinavir sulfate|
16389964|NCT00002199|Drug|Lamivudine/Zidovudine|
16389965|NCT00002199|Drug|Abacavir sulfate|
16389966|NCT00002198|Drug|Abacavir sulfate|
16389967|NCT00002197|Drug|Abacavir sulfate|
16389968|NCT00002196|Drug|CI-1012|
16389969|NCT00002195|Drug|Amprenavir|
16389970|NCT00002195|Drug|Lamivudine|
16389971|NCT00002195|Drug|Zidovudine|
16389972|NCT00002194|Drug|Erythromycin|
16389973|NCT00002194|Drug|Nevirapine|
16389974|NCT00002194|Drug|Clarithromycin|
16389975|NCT00002193|Drug|Amprenavir|
16389976|NCT00002192|Drug|Rifapentine|
16389977|NCT00002192|Drug|Ethambutol hydrochloride|
16389978|NCT00002192|Drug|Clarithromycin|
16389979|NCT00002192|Drug|Azithromycin|
16389980|NCT00002191|Drug|Albendazole|
16389981|NCT00002190|Drug|Saquinavir|
16389982|NCT00002190|Drug|Lamivudine|
16389983|NCT00002190|Drug|Zidovudine|
16389984|NCT00002189|Drug|Paclitaxel|
16389985|NCT00002188|Drug|Alitretinoin|
16389986|NCT00002187|Drug|Fomivirsen sodium|
16389987|NCT00002186|Drug|Crofelemer|
16389988|NCT00002186|Drug|Acyclovir|
16389989|NCT00002185|Drug|Nelfinavir mesylate|
16389990|NCT00002184|Drug|Nelfinavir mesylate|
16389991|NCT00002184|Drug|Levocarnitine|
16389992|NCT00002184|Drug|Adefovir dipivoxil|
16389993|NCT00002184|Drug|Saquinavir|
16389994|NCT00002184|Drug|Lamivudine|
16389995|NCT00002184|Drug|Stavudine|
16389996|NCT00002184|Drug|Zidovudine|
16389997|NCT00002183|Drug|Abacavir sulfate|
16389998|NCT00002183|Drug|Amprenavir|
16389999|NCT00002183|Drug|Lamivudine|
16390000|NCT00002183|Drug|Zidovudine|
16390001|NCT00002182|Drug|Megestrol acetate|
16390002|NCT00002181|Drug|Cidofovir|
16390003|NCT00002180|Drug|Tenofovir|
16390004|NCT00002179|Drug|Indinavir sulfate|
16390005|NCT00002179|Drug|Lamivudine|
16390006|NCT00002179|Drug|Zidovudine|
16390007|NCT00002178|Drug|Ritonavir|
16390008|NCT00002178|Drug|Nelfinavir mesylate|
16390009|NCT00002178|Drug|Saquinavir|
16390010|NCT00002178|Drug|Delavirdine mesylate|
16390011|NCT00002177|Drug|Hydroxyurea|
16390012|NCT00002177|Drug|Nelfinavir mesylate|
16390013|NCT00002177|Drug|Stavudine|
16390014|NCT00002177|Drug|Didanosine|
16390015|NCT00002176|Drug|Hydroxyurea|
16390016|NCT00002176|Drug|Nelfinavir mesylate|
16390017|NCT00002176|Drug|Stavudine|
16390018|NCT00002176|Drug|Didanosine|
16390019|NCT00002175|Drug|Dinitrochlorobenzene|
16390020|NCT00002174|Drug|Thalidomide|
16390021|NCT00002173|Biological|HIV-1 Immunogen|
16390022|NCT00002172|Biological|HIV-1 Immunogen|
16390023|NCT00002171|Drug|Nelfinavir mesylate|
16390024|NCT00002170|Drug|Nelfinavir mesylate|
16390025|NCT00002169|Drug|Nelfinavir mesylate|
16390026|NCT00002168|Drug|Indinavir sulfate|
16390027|NCT00002168|Drug|Lamivudine|
16390028|NCT00002168|Drug|Stavudine|
16390029|NCT00002168|Drug|Zidovudine|
16390030|NCT00002168|Drug|Didanosine|
16390031|NCT00002167|Drug|Tin ethyl etiopurpurin|
16390032|NCT00002166|Drug|Nevirapine|
16390033|NCT00002165|Drug|Nelfinavir mesylate|
16390034|NCT00002164|Drug|Nelfinavir mesylate|
16390035|NCT00002163|Drug|Abacavir sulfate|
16390036|NCT00002162|Drug|Saquinavir|
16390037|NCT00002162|Drug|Lamivudine|
16390038|NCT00002162|Drug|Stavudine|
16390039|NCT00002162|Drug|Zidovudine|
16390040|NCT00002162|Drug|Zalcitabine|
16390041|NCT00002162|Drug|Didanosine|
16390042|NCT00002161|Drug|Adefovir dipivoxil|
16390043|NCT00002160|Drug|Ziconotide|
16390044|NCT00002159|Drug|Itraconazole|
16390045|NCT00002159|Drug|Amphotericin B|
16390046|NCT00002158|Drug|Nitazoxanide|
16390047|NCT00002157|Drug|Thalidomide|
16390048|NCT00002156|Drug|Fomivirsen sodium|
16390049|NCT00002156|Drug|Ganciclovir|
16390050|NCT00002155|Drug|Indinavir sulfate|
16390051|NCT00002155|Drug|Lamivudine|
16390052|NCT00002155|Drug|Zidovudine|
16390053|NCT00002154|Drug|Thioctic acid|
16390054|NCT00002154|Drug|Selegiline hydrochloride|
16390055|NCT00002153|Drug|A-007|
16390056|NCT00002152|Drug|WF10|
16390057|NCT00002151|Drug|Celgosivir hydrochloride|
16390058|NCT00002150|Drug|Celgosivir hydrochloride|
16390059|NCT00002149|Drug|Clavulanate potassium|
16390060|NCT00002149|Drug|Pseudoephedrine hydrochloride|
16390061|NCT00002149|Drug|Amoxicillin trihydrate|
16390062|NCT00002148|Drug|OPC 14117|
16390063|NCT00002147|Drug|Doxorubicin hydrochloride (liposomal)|
16390064|NCT00002146|Drug|Magnesium sulfate|
16390065|NCT00002146|Drug|Foscarnet sodium|
16390066|NCT00002145|Drug|Foscarnet sodium|
16390067|NCT00002144|Drug|Foscarnet sodium|
16390068|NCT00002143|Drug|Acitretin|
16390069|NCT00002142|Drug|Cidofovir|
16390070|NCT00002142|Drug|Probenecid|
16390071|NCT00002141|Drug|Abacavir sulfate|
16390072|NCT00002140|Drug|Ethambutol hydrochloride|
16390073|NCT00002140|Drug|Clarithromycin|
16390074|NCT00002140|Drug|Azithromycin|
16390075|NCT00002139|Drug|Azithromycin|
16390076|NCT00002138|Drug|Tecogalan sodium|
16390077|NCT00002137|Drug|Tecogalan sodium|
16390078|NCT00002136|Drug|Tecogalan sodium|
16390079|NCT00002135|Drug|Ganciclovir|
16390080|NCT00002134|Drug|Ganciclovir|
16390081|NCT00002133|Drug|Itraconazole|
16390082|NCT00002132|Drug|Itraconazole|
16390083|NCT00002132|Drug|Fluconazole|
16390084|NCT00002131|Drug|Vesnarinone|
16390085|NCT00002130|Drug|Vesnarinone|
16390086|NCT00002129|Drug|Vesnarinone|
16390087|NCT00002128|Drug|Adefovir dipivoxil|
16390088|NCT00002127|Drug|Thalidomide|
16390089|NCT00002126|Drug|Filgrastim|
16390090|NCT00002125|Drug|Foscarnet sodium|
16390091|NCT00002124|Drug|Delavirdine mesylate|
16390092|NCT00002124|Drug|Lamivudine|
16390093|NCT00002124|Drug|Zidovudine|
16390094|NCT00002123|Drug|Delavirdine mesylate|
16390095|NCT00002123|Drug|Didanosine|
16390096|NCT00002122|Drug|Azithromycin|
16390097|NCT00002122|Drug|Rifabutin|
16390098|NCT00002122|Drug|Fluconazole|
16390099|NCT00002121|Drug|Diethylhomospermine|
16390100|NCT00002120|Drug|Trimetrexate glucuronate|
16390101|NCT00002120|Drug|Trimethoprim|
16390102|NCT00002120|Drug|Sulfamethoxazole|
16390103|NCT00002120|Drug|Dapsone|
16390104|NCT00002120|Drug|Leucovorin calcium|
16390105|NCT00002119|Drug|WF10|
16390106|NCT00002118|Drug|Zalcitabine|
16390107|NCT00002117|Drug|Zidovudine|
16390108|NCT00002117|Drug|Zalcitabine|
16390109|NCT00002116|Drug|Cidofovir|
16390110|NCT00002115|Drug|Adefovir|
16390111|NCT00002114|Drug|Procysteine|
16390112|NCT00002113|Drug|Flucytosine|
16390113|NCT00002113|Drug|Fluconazole|
16390114|NCT00002112|Drug|Nystatin|
16390115|NCT00002112|Drug|Fluconazole|
16390116|NCT00002111|Drug|Saquinavir|
16390117|NCT00002110|Drug|Cysteamine|
16390118|NCT00002110|Drug|Zidovudine|
16390119|NCT00002109|Drug|Thymopentin|
16390120|NCT00002109|Drug|Stavudine|
16390121|NCT00002109|Drug|Zidovudine|
16390122|NCT00002109|Drug|Zalcitabine|
16390123|NCT00002109|Drug|Didanosine|
16390124|NCT00002108|Drug|Lamivudine|
16390125|NCT00002108|Drug|Zidovudine|
16390126|NCT00002107|Drug|Aldesleukin|
16390127|NCT00002106|Drug|Ranitidine hydrochloride|
16390128|NCT00002105|Drug|Doxorubicin hydrochloride (liposomal)|
16390129|NCT00002105|Drug|Bleomycin sulfate|
16390130|NCT00002105|Drug|Vincristine sulfate|
16390131|NCT00002104|Drug|Thalidomide|
16390132|NCT00002103|Drug|Trimetrexate glucuronate|
16390133|NCT00002103|Drug|Leucovorin calcium|
16390134|NCT00002102|Drug|Trimetrexate glucuronate|
16390135|NCT00002102|Drug|Leucovorin calcium|
16390136|NCT00002101|Drug|Ethambutol hydrochloride|
16390137|NCT00002101|Drug|Clarithromycin|
16390138|NCT00002101|Drug|Rifabutin|
16390139|NCT00002100|Drug|Curdlan sulfate|
16390140|NCT00002099|Drug|Lentinan|
16390141|NCT00002099|Drug|Didanosine|
16390142|NCT00002098|Drug|Lentinan|
16390143|NCT00002098|Drug|Didanosine|
16390144|NCT00002097|Drug|Nystatin|
16390145|NCT00002096|Drug|Zidovudine|
16390146|NCT00002096|Drug|Didanosine|
16390147|NCT00002096|Drug|Ganciclovir|
16390148|NCT00002095|Drug|Ganciclovir|
16390149|NCT00002094|Drug|Atevirdine mesylate|
16390150|NCT00002093|Drug|Daunorubicin (liposomal)|
16390151|NCT00002093|Drug|Bleomycin sulfate|
16390152|NCT00002093|Drug|Vincristine sulfate|
16390153|NCT00002093|Drug|Doxorubicin hydrochloride|
16390154|NCT00002092|Drug|Cimetidine|
16390155|NCT00002091|Drug|Pentoxifylline|
16390156|NCT00002090|Drug|Azithromycin|
16390157|NCT00002089|Drug|Azithromycin|
16390158|NCT00002088|Drug|Saccharomyces boulardii|
16390159|NCT00002087|Drug|Alvircept sudotox|
16390160|NCT00002086|Drug|Zidovudine|
16390161|NCT00002086|Drug|Zalcitabine|
16390162|NCT00002086|Drug|Interferon alfa-n1|
16390163|NCT00002085|Drug|Azithromycin|
16390164|NCT00002084|Drug|Valacyclovir hydrochloride|
16390165|NCT00002084|Drug|Acyclovir|
16390166|NCT00002083|Drug|Peptide T|
16390167|NCT00002082|Drug|Azithromycin|
16390168|NCT00002081|Drug|Zidovudine|
16390169|NCT00002081|Drug|Zalcitabine|
16390170|NCT00002080|Drug|Rifabutin|
16390171|NCT00002079|Drug|Butyldeoxynojirimycin|
16390172|NCT00002079|Drug|Zidovudine|
16390173|NCT00002078|Drug|Interferon alfa-n3|
16390174|NCT00002077|Drug|Fluconazole|
16390175|NCT00002076|Drug|Fluconazole|
16390176|NCT00002075|Drug|Flucytosine|
16390177|NCT00002075|Drug|Fluconazole|
16390178|NCT00002075|Drug|Amphotericin B|
16390179|NCT00002074|Drug|Fluconazole|
16390180|NCT00002074|Drug|Amphotericin B|
16390181|NCT00002073|Drug|Epoetin alfa|
16390182|NCT00002072|Drug|Epoetin alfa|
16390183|NCT00002071|Drug|Epoetin alfa|
16390184|NCT00002070|Drug|Sargramostim|
16390185|NCT00002070|Drug|Ganciclovir|
16390186|NCT00002069|Drug|Ditiocarb sodium|
16390187|NCT00002068|Drug|Fluconazole|
16390188|NCT00002068|Drug|Amphotericin B|
16390189|NCT00002067|Drug|Megestrol acetate|
16390190|NCT00002066|Drug|Thymopentin|
16390191|NCT00002065|Drug|Disulfiram|
16390192|NCT00002064|Drug|Pyrimethamine|
16390193|NCT00002064|Drug|Clindamycin|
16390194|NCT00002063|Drug|Zidovudine|
16390195|NCT00002062|Drug|Spiramycin|
16390196|NCT00002061|Drug|Inosine pranobex|
16390197|NCT00002060|Drug|Inosine pranobex|
16390198|NCT00002059|Drug|Inosine pranobex|
16390199|NCT00002058|Drug|Clofazimine|
16390200|NCT00002057|Drug|Nystatin|
16390201|NCT00002056|Drug|Pentamidine isethionate|
16390202|NCT00002055|Drug|Pentamidine isethionate|
16390203|NCT00002054|Drug|Pentamidine isethionate|
16390204|NCT00002053|Drug|Pentamidine isethionate|
16390205|NCT00002052|Drug|Ceftriaxone sodium|
16390206|NCT00002052|Drug|Ampicillin sodium|
16390207|NCT00002052|Drug|Amoxicillin trihydrate|
16390208|NCT00002051|Drug|Thymopentin|
16390209|NCT00002050|Drug|Thymopentin|
16390210|NCT00002049|Drug|Thymopentin|
16390211|NCT00002048|Drug|Zidovudine|
16390212|NCT00002047|Drug|Zidovudine|
16390213|NCT00002046|Drug|Zidovudine|
16390214|NCT00002045|Drug|Zidovudine|
16390215|NCT00002044|Drug|Zidovudine|
16390216|NCT00002043|Drug|Dapsone|
16390217|NCT00002042|Drug|Epoetin alfa|
16390218|NCT00002041|Drug|Amphotericin B|
16390219|NCT00002040|Drug|Fluconazole|
16390220|NCT00002039|Drug|Foscarnet sodium|
16390221|NCT00002038|Drug|Fluconazole|
16390222|NCT00002037|Drug|Trifluridine|
16390223|NCT00002036|Drug|Anti-HIV Immune Serum Globulin (Human)|
16390224|NCT00002035|Drug|Zidovudine|
16390225|NCT00002035|Drug|Didanosine|
16390226|NCT00002034|Drug|Zidovudine|
16390227|NCT00002034|Drug|Ganciclovir|
16390228|NCT00002033|Drug|Zidovudine|
16390229|NCT00002033|Drug|AS-101|
16390230|NCT00002032|Drug|Rifabutin|
16390231|NCT00002031|Drug|Dinitrochlorobenzene|
16390232|NCT00002030|Drug|Pentamidine isethionate|
16390233|NCT00002029|Drug|Fat Emulsion 2%|
16390234|NCT00002029|Drug|Fat Emulsion 20%|
16390235|NCT00002028|Drug|Didanosine|
16390236|NCT00002027|Drug|Diclazuril|
16390237|NCT00002026|Drug|Acyclovir|
16390238|NCT00002025|Drug|Ganciclovir|
16390239|NCT00002024|Drug|Ganciclovir|
16390240|NCT00002023|Drug|Zidovudine|
16390241|NCT00002022|Drug|Epoetin alfa|
16390242|NCT00002021|Drug|Foscarnet sodium|
16390243|NCT00002020|Drug|Zidovudine|
16390244|NCT00002019|Drug|Amphotericin B, Lipid-based|
16390245|NCT00002019|Drug|Amphotericin B|
16390246|NCT00002018|Drug|Interferon alfa-n3|
16390247|NCT00002017|Drug|Interleukin-2, Polyethylene Glycolated|
16390248|NCT00002016|Drug|Sevirumab|
16390249|NCT00002015|Drug|Ganciclovir|
16390250|NCT00002014|Drug|Zidovudine|
16390251|NCT00002014|Drug|Didanosine|
16390252|NCT00002013|Drug|Zidovudine|
16390253|NCT00002013|Drug|AS-101|
16390254|NCT00002012|Drug|Interferon alfa-n3|
16390255|NCT00002011|Drug|Methoxsalen|
16390256|NCT00002010|Drug|Fluconazole|
16390257|NCT00002009|Drug|Sargramostim|
16390258|NCT00002008|Drug|Sargramostim|
16390259|NCT00002007|Drug|Zidovudine|
16390260|NCT00002007|Drug|Sargramostim|
16390261|NCT00002006|Drug|Zidovudine|
16390262|NCT00002006|Drug|Sargramostim|
16390263|NCT00002005|Drug|CD4 Antigens|
16390264|NCT00002004|Drug|CD4 Antigens|
16390265|NCT00002003|Drug|Mitoxantrone hydrochloride|
16390266|NCT00002003|Drug|Etoposide|
16390267|NCT00002002|Drug|Trimethoprim|
16390268|NCT00002002|Drug|Sulfamethoxazole|
16390269|NCT00002002|Drug|Leucovorin calcium|
16390270|NCT00002001|Drug|Zidovudine|
16390271|NCT00002001|Drug|Zalcitabine|
16390272|NCT00002001|Drug|Didanosine|
16390273|NCT00002000|Drug|Valacyclovir hydrochloride|
16390274|NCT00002000|Drug|Acyclovir|
16390275|NCT00001999|Drug|Globulin, Immune|
16390276|NCT00001999|Drug|Ganciclovir|
16390277|NCT00001998|Drug|Nystatin|
16390278|NCT00001997|Drug|Interleukin-2, Polyethylene Glycolated|
16390279|NCT00001997|Drug|Zidovudine|
16390280|NCT00001997|Drug|Didanosine|
16390281|NCT00001996|Drug|Atovaquone|
16390282|NCT00001996|Drug|Pentamidine isethionate|
16390283|NCT00001995|Drug|Rifabutin|
16390284|NCT00001994|Drug|Atovaquone|
16390285|NCT00001993|Drug|Butyldeoxynojirimycin|
16390286|NCT00001993|Drug|Zidovudine|
16390287|NCT00001992|Biological|rgp120/HIV-1IIIB|
16390288|NCT00001991|Drug|Atovaquone|
16390289|NCT00001990|Drug|Atovaquone|
16390290|NCT00001989|Drug|Trichosanthin|
16390291|NCT00001989|Drug|Zidovudine|
16390292|NCT00001136|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390293|NCT00001135|Drug|Nevirapine|
16390294|NCT00001133|Drug|Indinavir sulfate|
16390295|NCT00001133|Drug|Ritonavir|
16390296|NCT00001132|Drug|Abacavir sulfate|
16390297|NCT00001131|Drug|Aldesleukin|Subcutaneous injection of IL-2 in the amount of 2.0 X 10^6 mIU per day for the entire duration of therapy
16390298|NCT00001131|Drug|HAART|Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met
16390299|NCT00001129|Device|Electronic Medication Reminder System|
16390300|NCT00001129|Behavioral|Medication Manager|
16390301|NCT00001128|Drug|Interleukin-12|
16390302|NCT00001128|Drug|Paromomycin sulfate|
16390303|NCT00001128|Drug|Azithromycin|
16390304|NCT00001127|Biological|Influenza virus vaccine (CAIV-T)|
16390305|NCT00001126|Drug|Cidofovir|
16390306|NCT00001125|Biological|Varicella Virus Vaccine (Live)|
16390307|NCT00001123|Drug|Ribavirin|
16390308|NCT00001122|Drug|Nelfinavir mesylate|
16390309|NCT00001122|Drug|Efavirenz|
16390310|NCT00001122|Drug|Stavudine|
16390311|NCT00001122|Drug|Didanosine|
16390312|NCT00001119|Biological|Tetanus Toxoid Vaccine|
16390313|NCT00001119|Drug|Indinavir sulfate|
16390314|NCT00001119|Drug|Lamivudine/Zidovudine|
16390315|NCT00001119|Drug|Ritonavir|
16390316|NCT00001119|Drug|Abacavir sulfate|
16390317|NCT00001119|Drug|Amprenavir|
16390318|NCT00001119|Drug|Efavirenz|
16390319|NCT00001119|Biological|Hepatitis B Vaccine (Recombinant)|
16390320|NCT00001119|Drug|Lamivudine|
16390321|NCT00001119|Drug|Zidovudine|
16390322|NCT00001118|Drug|Enfuvirtide|
16390323|NCT00001116|Drug|Tumor Necrosis Factor soluble receptor-immunoadhesin complex|
16390324|NCT00001115|Drug|Acyclovir|
16390325|NCT00001114|Drug|Interferon alfa-2b|
16390326|NCT00001114|Drug|Didanosine|
16390327|NCT00001113|Drug|Interferon alfa-2a|
16390328|NCT00001113|Drug|Zidovudine|
16390329|NCT00001113|Drug|Interferon alfa-n1|
16390330|NCT00001112|Drug|Zidovudine|
16390331|NCT00001112|Drug|Interferon gamma-1b|
16390332|NCT00001111|Drug|Nevirapine|
16390333|NCT00001111|Drug|Zidovudine|
16390334|NCT00001110|Procedure|Bronchoalveolar lavage|
16390335|NCT00001108|Drug|Ritonavir|
16390336|NCT00001108|Drug|Nelfinavir mesylate|
16390337|NCT00001108|Drug|Saquinavir|
16390338|NCT00001108|Drug|Nevirapine|
16390339|NCT00001108|Drug|Lamivudine|
16390340|NCT00001108|Drug|Stavudine|
16390341|NCT00001108|Drug|Didanosine|
16390342|NCT00001107|Drug|Fluconazole|
16390343|NCT00001107|Drug|AmBisome|
16390344|NCT00001106|Drug|Zidovudine|
16390345|NCT00001105|Drug|F105 Monoclonal Antibody (Human)|
16390346|NCT00001104|Drug|Zidovudine|
16390347|NCT00001101|Drug|ceftriaxone|
16390348|NCT00001101|Drug|doxycycline|
16390349|NCT00001100|Drug|ganciclovir|
16390350|NCT00001096|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
16390351|NCT00001096|Biological|QS-21|
16390352|NCT00001096|Biological|rgp120/HIV-1MN|
16390353|NCT00001095|Drug|Indinavir sulfate|
16390354|NCT00001095|Drug|Amprenavir|
16390355|NCT00001095|Drug|Nevirapine|
16390356|NCT00001095|Drug|Lamivudine|
16390357|NCT00001095|Drug|Stavudine|
16390358|NCT00001095|Drug|Zidovudine|
16390359|NCT00001094|Drug|Lamivudine/Zidovudine|
16390360|NCT00001094|Drug|Nelfinavir mesylate|
16390361|NCT00001094|Drug|Saquinavir|
16390362|NCT00001094|Drug|Delavirdine mesylate|
16390363|NCT00001091|Drug|Ritonavir|
16390364|NCT00001091|Drug|Nelfinavir mesylate|
16390365|NCT00001091|Drug|Nevirapine|
16390366|NCT00001091|Drug|Lamivudine|
16390367|NCT00001091|Drug|Stavudine|
16390368|NCT00001090|Biological|APL 400-047|
16390369|NCT00001090|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390370|NCT00001090|Drug|Sargramostim|
16390371|NCT00001088|Biological|APL 400-047|
16390372|NCT00001088|Drug|Bupivacaine hydrochloride|
16390373|NCT00001087|Drug|Ritonavir|
16390374|NCT00001087|Drug|Nelfinavir mesylate|
16390375|NCT00001087|Drug|Efavirenz|
16390376|NCT00001087|Drug|Levocarnitine|
16390377|NCT00001087|Drug|Adefovir dipivoxil|
16390378|NCT00001087|Drug|Saquinavir|
16390379|NCT00001087|Drug|Lamivudine|
16390380|NCT00001087|Drug|Stavudine|
16390381|NCT00001087|Drug|Zidovudine|
16390382|NCT00001087|Drug|Zalcitabine|
16390383|NCT00001087|Drug|Didanosine|
16390384|NCT00001086|Drug|Indinavir sulfate|
16390385|NCT00001086|Drug|Abacavir sulfate|
16390386|NCT00001086|Drug|Efavirenz|
16390387|NCT00001085|Drug|Amprenavir|
16390388|NCT00001085|Drug|Lamivudine|
16390389|NCT00001085|Drug|Zidovudine|
16390390|NCT00001084|Drug|Indinavir sulfate|
16390391|NCT00001084|Drug|Lamivudine|
16390392|NCT00001084|Drug|Stavudine|
16390393|NCT00001084|Drug|Zidovudine|
16390394|NCT00001083|Drug|Indinavir sulfate|
16390395|NCT00001083|Drug|Ritonavir|
16390396|NCT00001083|Drug|Nevirapine|
16390397|NCT00001083|Drug|Lamivudine|
16390398|NCT00001083|Drug|Stavudine|
16390399|NCT00001083|Drug|Zidovudine|
16390400|NCT00001082|Drug|Levocarnitine|500 mg tablet taken orally daily
16390401|NCT00001082|Drug|Adefovir dipivoxil|120 mg tablet taken orally daily
16390402|NCT00001082|Drug|Adefovir dipivoxil placebo|Oral placebo tablet taken daily
16390403|NCT00001081|Drug|Nitazoxanide|
16390404|NCT00001080|Biological|Influenza Virus Vaccine|
16390405|NCT00001080|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|
16390406|NCT00001080|Drug|Lamivudine|
16390407|NCT00001079|Drug|Testosterone enanthate|
16390408|NCT00001079|Drug|Megestrol acetate|
16390409|NCT00001078|Biological|Hepatitis A Vaccine (Inactivated)|
16390410|NCT00001077|Dietary Supplement|Multivitamin and mineral supplements|Oral tablets taken daily
16390411|NCT00001077|Dietary Supplement|Peptamen|Solution received daily
16390412|NCT00001077|Dietary Supplement|NuBasics|Solution or dietary bar received daily
16390413|NCT00001076|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390414|NCT00001076|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16390415|NCT00001076|Biological|rgp120/HIV-1 SF-2|
16390416|NCT00001075|Drug|Ritonavir|
16390417|NCT00001075|Drug|Lamivudine|
16390418|NCT00001075|Drug|Zidovudine|
16390419|NCT00001074|Drug|Hydroxyurea|
16390420|NCT00001074|Drug|Didanosine|
16390421|NCT00001073|Drug|Isotretinoin|
16390422|NCT00001072|Biological|ALVAC-HIV MN120TMGNP (vCP300)|
16390423|NCT00001072|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16390424|NCT00001072|Biological|rgp120/HIV-1 SF-2|
16390425|NCT00001071|Drug|Filgrastim|
16390426|NCT00001070|Drug|Oral Vitamin C|
16390427|NCT00001068|Drug|Lamivudine|
16390428|NCT00001067|Drug|Lamivudine|
16390429|NCT00001067|Drug|Stavudine|
16390430|NCT00001067|Drug|Zidovudine|
16390431|NCT00001066|Drug|Lamivudine|
16390432|NCT00001066|Drug|Zidovudine|
16390433|NCT00001066|Drug|Didanosine|
16390434|NCT00001065|Drug|Amphotericin B|
16390435|NCT00001064|Drug|Allogenic Dendritic Cells|
16390436|NCT00001063|Drug|Stavudine|
16390437|NCT00001063|Drug|Zidovudine|
16390438|NCT00001063|Drug|Didanosine|
16390439|NCT00001062|Drug|Ganciclovir|
16390440|NCT00001061|Drug|Sevirumab|
16390441|NCT00001061|Drug|Foscarnet sodium|
16390442|NCT00001061|Drug|Ganciclovir|
16390443|NCT00001060|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
16390444|NCT00001059|Drug|Doxorubicin hydrochloride (liposomal)|
16390445|NCT00001059|Drug|Filgrastim|
16390446|NCT00001059|Drug|Bleomycin sulfate|
16390447|NCT00001059|Drug|Vincristine sulfate|
16390448|NCT00001058|Drug|Indinavir sulfate|
16390449|NCT00001058|Drug|Ritonavir|
16390450|NCT00001058|Drug|Ethambutol hydrochloride|
16390451|NCT00001058|Drug|Clarithromycin|
16390452|NCT00001058|Drug|Rifabutin|
16390453|NCT00001057|Drug|Zidovudine|
16390454|NCT00001057|Drug|Didanosine|
16390455|NCT00001056|Biological|gp160 Vaccine (Immuno-AG)|
16390456|NCT00001055|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390457|NCT00001055|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16390458|NCT00001055|Biological|rgp120/HIV-1 SF-2|
16390459|NCT00001054|Drug|Valacyclovir hydrochloride|
16390460|NCT00001053|Biological|HIV p17/p24:Ty-VLP|
16390461|NCT00001053|Biological|Aluminum hydroxide|
16390462|NCT00001052|Biological|Aluminum hydroxide|
16390463|NCT00001052|Biological|QS-21|
16390464|NCT00001052|Biological|rgp120/HIV-1MN|
16390465|NCT00001049|Drug|Zidovudine|
16390466|NCT00001049|Drug|Didanosine|
16390467|NCT00001048|Drug|Filgrastim|
16390468|NCT00001048|Drug|Cytarabine|
16390469|NCT00001048|Drug|Zidovudine|
16390470|NCT00001048|Drug|Zalcitabine|
16390471|NCT00001048|Drug|Didanosine|
16390472|NCT00001047|Drug|Ethambutol hydrochloride|
16390473|NCT00001047|Drug|Clarithromycin|
16390474|NCT00001047|Drug|Clofazimine|
16390475|NCT00001047|Drug|Rifabutin|
16390476|NCT00001046|Biological|MF59|
16390477|NCT00001046|Biological|rgp120/HIV-1 SF-2|
16390478|NCT00001045|Drug|Nevirapine|
16390479|NCT00001045|Drug|Zidovudine|
16390480|NCT00001045|Drug|Didanosine|
16390481|NCT00001044|Biological|Aluminum hydroxide|
16390482|NCT00001044|Biological|QS-21|
16390483|NCT00001044|Biological|rgp120/HIV-1MN|
16390484|NCT00001043|Biological|gp160 Vaccine (Immuno-AG)|
16390485|NCT00001042|Biological|Aluminum hydroxide|
16390486|NCT00001042|Biological|Lipid A, Monophosphoryl|
16390487|NCT00001042|Biological|Lipid A, Liposome-encapsulated monophosphoryl|
16390488|NCT00001042|Biological|Syntex adjuvant formulation|
16390489|NCT00001042|Biological|MF59|
16390490|NCT00001042|Biological|Threonyl Muramyl Dipeptide|
16390491|NCT00001042|Biological|rgp120/HIV-1 SF-2|
16390492|NCT00001042|Biological|MTP-PE/MF59|
16390493|NCT00001041|Biological|rgp120/HIV-1MN|
16390494|NCT00001040|Drug|Saquinavir|
16390495|NCT00001040|Drug|Zidovudine|
16390496|NCT00001040|Drug|Zalcitabine|
16390497|NCT00001039|Drug|Ethambutol hydrochloride|
16390498|NCT00001039|Drug|Clarithromycin|
16390499|NCT00001038|Drug|Valacyclovir hydrochloride|
16390500|NCT00001038|Drug|Acyclovir|
16390501|NCT00001037|Biological|gp160 Vaccine (Immuno-AG)|
16390502|NCT00001036|Drug|Thymalfasin|
16390503|NCT00001036|Drug|Interleukin-2, Polyethylene Glycolated|
16390504|NCT00001036|Drug|Zidovudine|
16390505|NCT00001035|Drug|Interferon alfa-2b|
16390506|NCT00001035|Drug|Zidovudine|
16390507|NCT00001035|Drug|Zalcitabine|
16390508|NCT00001035|Drug|Didanosine|
16390509|NCT00001034|Drug|Ganciclovir|
16390510|NCT00001033|Drug|Ethambutol hydrochloride|
16390511|NCT00001033|Drug|Isoniazid|
16390512|NCT00001033|Drug|Pyrazinamide|
16390513|NCT00001033|Drug|Pyridoxine hydrochloride|
16390514|NCT00001033|Drug|Levofloxacin|
16390515|NCT00001033|Drug|Rifampin|
16390516|NCT00001032|Drug|Zidovudine|
16390517|NCT00001032|Drug|Zalcitabine|
16390518|NCT00001031|Biological|rgp120/HIV-1MN|
16390519|NCT00001031|Biological|rgp120/HIV-1 SF-2|
16390520|NCT00001030|Drug|Clarithromycin|
16390521|NCT00001030|Drug|Rifabutin|
16390522|NCT00001029|Drug|Zidovudine|
16390523|NCT00001029|Drug|Zalcitabine|
16390524|NCT00001029|Drug|Didanosine|
16390525|NCT00001028|Drug|Pentamidine isethionate|
16390526|NCT00001028|Drug|Dapsone|
16390527|NCT00001027|Drug|Pentamidine isethionate|
16390528|NCT00001026|Biological|gp160 Vaccine (Immuno-AG)|
16390529|NCT00001026|Biological|rgp120/HIV-1IIIB|
16390530|NCT00001026|Biological|rgp120/HIV-1MN|
16390531|NCT00001026|Biological|rgp120/HIV-1 SF-2|
16390532|NCT00001026|Biological|HIVAC-1e|
16390533|NCT00001025|Drug|Zidovudine|
16390534|NCT00001025|Drug|Didanosine|
16390535|NCT00001024|Drug|Zidovudine|
16390536|NCT00001024|Drug|Didanosine|
16390537|NCT00001023|Drug|Clarithromycin|
16390538|NCT00001023|Drug|Azithromycin|
16390539|NCT00001023|Drug|Rifabutin|
16390540|NCT00001022|Drug|Zidovudine|
16390541|NCT00001022|Drug|Zalcitabine|
16390542|NCT00001022|Drug|Didanosine|
16390543|NCT00001021|Biological|rgp120/HIV-1IIIB|
16390544|NCT00001021|Biological|rgp120/HIV-1MN|
16390545|NCT00001020|Biological|rgp120/HIV-1IIIB|
16390546|NCT00001020|Biological|rgp120/HIV-1MN|
16390547|NCT00001019|Biological|rgp120/HIV-1 SF-2|
16390548|NCT00001019|Biological|MTP-PE/MF59|
16390549|NCT00001018|Drug|Letrazuril|
16390550|NCT00001017|Drug|Fluconazole|
16390551|NCT00001017|Drug|Amphotericin B|
16390552|NCT00001016|Drug|Trimetrexate glucuronate|
16390553|NCT00001016|Drug|Leucovorin calcium|
16390554|NCT00001015|Drug|Ribavirin|
16390555|NCT00001014|Drug|Trimetrexate glucuronate|
16390556|NCT00001014|Drug|Sulfamethoxazole-Trimethoprim|
16390557|NCT00001014|Drug|Leucovorin calcium|
16390558|NCT00001013|Drug|Trimetrexate glucuronate|
16390559|NCT00001013|Drug|Pentamidine isethionate|
16390560|NCT00001013|Drug|Sulfamethoxazole-Trimethoprim|
16390561|NCT00001013|Drug|Leucovorin calcium|
16390562|NCT00001012|Drug|AL 721|
16390563|NCT00001011|Drug|Zidovudine|
16390564|NCT00001010|Drug|Zidovudine|
16390565|NCT00001010|Drug|Acyclovir|
16390566|NCT00001009|Drug|Dextran sulfate|
16390567|NCT00001008|Drug|Methadone hydrochloride|
16390568|NCT00001008|Drug|Zidovudine|
16390569|NCT00001007|Drug|Zidovudine|
16390570|NCT00001006|Drug|AS-101|
16390571|NCT00001005|Drug|Zidovudine|
16390572|NCT00001005|Drug|Aldesleukin|
16390573|NCT00001004|Drug|Tumor Necrosis Factor|
16390574|NCT00001004|Drug|Interferon gamma-1b|
16390575|NCT00001003|Drug|Pentamidine isethionate|
16390576|NCT00001003|Drug|Zidovudine|
16390577|NCT00001002|Drug|Zidovudine|
16390578|NCT00001002|Drug|Foscarnet sodium|
16390579|NCT00001001|Drug|Zidovudine|
16390580|NCT00001000|Drug|Ampligen|
16390581|NCT00000999|Drug|Zidovudine|
16390582|NCT00000998|Drug|Trimetrexate glucuronate|
16390583|NCT00000998|Drug|Leucovorin calcium|
16390584|NCT00000997|Drug|Zalcitabine|
16390585|NCT00000996|Drug|Doxorubicin hydrochloride|
16390586|NCT00000995|Drug|Zidovudine|
16390587|NCT00000995|Drug|Ganciclovir|
16390588|NCT00000994|Drug|Zidovudine|
16390589|NCT00000993|Drug|Zidovudine|
16390590|NCT00000992|Drug|Itraconazole|
16390591|NCT00000991|Drug|Pentamidine isethionate|
16390592|NCT00000991|Drug|Sulfamethoxazole-Trimethoprim|
16390593|NCT00000991|Drug|Dapsone|
16390594|NCT00000991|Drug|Zidovudine|
16390595|NCT00000990|Drug|Zidovudine|
16390596|NCT00000989|Drug|Zidovudine|
16390597|NCT00000989|Drug|Sargramostim|
16390598|NCT00000989|Drug|Ganciclovir|
16390599|NCT00000988|Drug|Stavudine|
16390600|NCT00000987|Drug|Bleomycin sulfate|
16390601|NCT00000987|Drug|Vincristine sulfate|
16390602|NCT00000987|Drug|Doxorubicin hydrochloride|
16390603|NCT00000987|Drug|Zidovudine|
16390604|NCT00000986|Drug|Zidovudine|
16390605|NCT00000986|Drug|Aldesleukin|
16390606|NCT00000985|Drug|Vidarabine|
16390607|NCT00000985|Drug|Acyclovir|
16390608|NCT00000985|Drug|Foscarnet sodium|
16390609|NCT00000984|Drug|CD4 Antigens|
16390610|NCT00000983|Drug|Zidovudine|
16390611|NCT00000982|Drug|Zidovudine|
16390612|NCT00000982|Drug|Didanosine|
16390613|NCT00000981|Drug|Fiacitabine|
16390614|NCT00000980|Drug|Spiramycin|
16390615|NCT00000979|Drug|Zidovudine|
16390616|NCT00000979|Drug|Didanosine|
16390617|NCT00000978|Drug|Zidovudine|
16390618|NCT00000978|Drug|Zalcitabine|
16390619|NCT00000977|Biological|gp160 Vaccine (MicroGeneSys)|
16390620|NCT00000976|Drug|CD4-IgG|
16390621|NCT00000976|Drug|Zidovudine|
16390622|NCT00000975|Drug|Itraconazole|
16390623|NCT00000974|Drug|Pentamidine isethionate|
16390624|NCT00000973|Drug|Pyrimethamine|
16390625|NCT00000973|Drug|Leucovorin calcium|
16390626|NCT00000973|Drug|Zidovudine|
16390627|NCT00000972|Biological|MTP-PE/MF59|
16390628|NCT00000972|Biological|Env 2-3|
16390629|NCT00000971|Drug|Clarithromycin|
16390630|NCT00000971|Drug|Zidovudine|
16390631|NCT00000971|Drug|Didanosine|
16390632|NCT00000970|Drug|Foscarnet sodium|
16390633|NCT00000970|Drug|Ganciclovir|
16390634|NCT00000969|Drug|Zalcitabine|
16390635|NCT00000969|Drug|Didanosine|
16390636|NCT00000968|Biological|gp160 Vaccine (Immuno-AG)|
16390639|NCT00000966|Drug|Azithromycin|
16390640|NCT00000966|Drug|Pyrimethamine|
16390641|NCT00000966|Drug|Leucovorin calcium|
16390642|NCT00000965|Drug|Zidovudine|
16390646|NCT00000962|Drug|Nevirapine|
16390647|NCT00000961|Drug|Anti-HIV Immune Serum Globulin (Human)|
16390648|NCT00000961|Drug|Zidovudine|
16390650|NCT00000959|Drug|Isoniazid|
16390651|NCT00000959|Drug|Pyridoxine hydrochloride|
16390652|NCT00000958|Biological|MTP-PE/MF59|
16390653|NCT00000958|Biological|Env 2-3|
16390654|NCT00000957|Biological|gp160 Vaccine (Immuno-AG)|
16390655|NCT00000956|Biological|gp160 Vaccine (MicroGeneSys)|
16390656|NCT00000955|Drug|Tuberculin Purified Protein Derivative|Administered intradermally at 5 TU per 0.1 mL
16390662|NCT00000953|Drug|Sorivudine|
16390663|NCT00000953|Drug|Acyclovir|
16390668|NCT00000950|Drug|Ethambutol hydrochloride|
16390669|NCT00000950|Drug|Isoniazid|
16390670|NCT00000950|Drug|Pyrazinamide|
16390671|NCT00000950|Drug|Pyridoxine hydrochloride|
16390672|NCT00000950|Drug|Rifampin|
16390676|NCT00000947|Drug|Azithromycin|
16390706|NCT00000938|Drug|ceftriaxone|
16390707|NCT00000938|Drug|doxycycline|
16390708|NCT00000937|Drug|Antibiotics|
16390709|NCT00000936|Drug|hOKT3|Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.
16390710|NCT00000936|Drug|Oral Cyclosporine|Administered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study.
16390711|NCT00000936|Drug|IV Cyclosporine|Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.
16390712|NCT00000935|Biological|Intravenous immune globulin (IVIG)|given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)
16390713|NCT00000931|Behavioral|Behavioral intervention|
16390714|NCT00000931|Behavioral|Risk-reduction counseling|
16390716|NCT00000928|Behavioral|Group counseling intervention|Participants will engage in a multi-session group-based condom promotion program for approximately 12 months
16390717|NCT00000927|Drug|BufferGel|
16390719|NCT00000925|Drug|Optimune oral nutritional supplement|
16390725|NCT00000923|Drug|Indinavir sulfate|
16390726|NCT00000923|Drug|Lamivudine|
16390727|NCT00000923|Drug|Stavudine|
16390728|NCT00000923|Drug|Zidovudine|
16390729|NCT00000923|Drug|Didanosine|
16390730|NCT00000923|Drug|Aldesleukin|
16390731|NCT00000922|Drug|Indinavir sulfate|
16390732|NCT00000922|Drug|Abacavir sulfate|
16390733|NCT00000922|Drug|Nelfinavir mesylate|
16390734|NCT00000922|Drug|Efavirenz|
16390735|NCT00000922|Drug|Nevirapine|
16390736|NCT00000922|Drug|Lamivudine|
16390737|NCT00000922|Drug|Stavudine|
16390738|NCT00000922|Drug|Didanosine|
16390739|NCT00000921|Drug|Prednisone|
16390744|NCT00000919|Drug|Indinavir sulfate|
16390745|NCT00000919|Drug|Lamivudine/Zidovudine|
16390746|NCT00000919|Drug|Ritonavir|
16390747|NCT00000919|Drug|Hydroxyurea|
16390748|NCT00000919|Drug|Abacavir sulfate|
16390749|NCT00000919|Drug|Amprenavir|
16390750|NCT00000919|Drug|Nelfinavir mesylate|
16390751|NCT00000919|Drug|Efavirenz|
16390752|NCT00000919|Drug|Lamivudine|
16390753|NCT00000919|Drug|Stavudine|
16390754|NCT00000919|Drug|Zidovudine|
16390755|NCT00000919|Drug|Didanosine|
16390756|NCT00000918|Drug|Indinavir sulfate|
16390757|NCT00000918|Drug|Lamivudine/Zidovudine|
16390758|NCT00000918|Drug|Ritonavir|
16390759|NCT00000918|Drug|Amprenavir|
16390760|NCT00000918|Drug|Efavirenz|
16390761|NCT00000918|Drug|Saquinavir|
16390762|NCT00000918|Drug|Lamivudine|
16390763|NCT00000918|Drug|Stavudine|
16390764|NCT00000918|Drug|Zidovudine|
16390765|NCT00000918|Drug|Didanosine|
16390773|NCT00000915|Behavioral|Vaccine preparedness|
16390790|NCT00000906|Drug|Ritonavir|
16390791|NCT00000906|Drug|Saquinavir|
16390792|NCT00000906|Drug|Methadone hydrochloride|
16390793|NCT00000904|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16390794|NCT00000904|Biological|gp160 MN/LAI-2|
16390795|NCT00000904|Biological|ALVAC(1)120(B,MN)GNP (vCP1433)|
16390796|NCT00000904|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390797|NCT00000904|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16390798|NCT00000903|Drug|Indinavir sulfate|
16390799|NCT00000903|Drug|Lamivudine/Zidovudine|
16390800|NCT00000903|Drug|Nelfinavir mesylate|
16390801|NCT00000903|Drug|Efavirenz|
16390821|NCT00000897|Drug|Zidovudine|
16390832|NCT00000894|Drug|Cidofovir|
16390833|NCT00000894|Drug|Probenecid|
16390834|NCT00000894|Drug|Ganciclovir|
16390837|NCT00000892|Drug|Ritonavir|
16390838|NCT00000892|Drug|Nelfinavir mesylate|
16390839|NCT00000892|Drug|Levocarnitine|
16390840|NCT00000892|Drug|Adefovir dipivoxil|
16390841|NCT00000892|Drug|Saquinavir|
16390842|NCT00000892|Drug|Delavirdine mesylate|
16390843|NCT00000891|Drug|Ritonavir|
16390844|NCT00000891|Drug|Saquinavir|
16390845|NCT00000891|Drug|Delavirdine mesylate|
16390846|NCT00000891|Drug|Lamivudine|
16390847|NCT00000891|Drug|Stavudine|
16390848|NCT00000891|Drug|Zidovudine|
16390849|NCT00000891|Drug|Didanosine|
16390871|NCT00000883|Drug|Azithromycin|
16390872|NCT00000882|Drug|Indinavir sulfate|
16390873|NCT00000882|Drug|Delavirdine mesylate|
16390874|NCT00000882|Drug|Lamivudine|
16390875|NCT00000882|Drug|Stavudine|
16390876|NCT00000882|Drug|Zidovudine|
16390888|NCT00000876|Drug|CD4-IgG2|
16390889|NCT00000875|Drug|Indinavir sulfate|
16390890|NCT00000875|Drug|Diphenhydramine hydrochloride|
16390891|NCT00000875|Drug|Lymphocytes, Activated|
16390892|NCT00000875|Drug|Lamivudine|
16390893|NCT00000875|Drug|Zidovudine|
16390894|NCT00000875|Drug|Acetaminophen|
16390895|NCT00000875|Drug|Aldesleukin|
16390896|NCT00000873|Drug|Infant Formula|
16390897|NCT00000872|Drug|Abacavir sulfate|
16390898|NCT00000872|Drug|Nelfinavir mesylate|
16390899|NCT00000872|Drug|Nevirapine|
16390900|NCT00000872|Drug|Lamivudine|
16390901|NCT00000872|Drug|Stavudine|
16390902|NCT00000872|Drug|Zidovudine|
16390903|NCT00000871|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
16390904|NCT00000871|Biological|MN rgp120/HIV-1 and A244 rgp120/HIV-1|
16390905|NCT00000871|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390906|NCT00000871|Biological|rgp120/HIV-1 SF-2|
16390907|NCT00000870|Drug|Indinavir sulfate|
16390908|NCT00000870|Drug|Lamivudine|
16390909|NCT00000870|Drug|Stavudine|
16390910|NCT00000870|Drug|Zidovudine|
16390911|NCT00000870|Drug|Didanosine|
16390912|NCT00000870|Drug|Aldesleukin|
16390918|NCT00000867|Drug|Memantine|
16390939|NCT00000853|Biological|rgp120/HIV-1MN|
16390940|NCT00000852|Procedure|Allogeneic lymphocyte transfer|
16390941|NCT00000851|Drug|Stavudine|
16390942|NCT00000851|Drug|Didanosine|
16390946|NCT00000848|Drug|Indinavir sulfate|
16390947|NCT00000848|Drug|Saquinavir|
16390948|NCT00000847|Biological|ALVAC-HIV MN120TMG (vCP205)|
16390949|NCT00000847|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16390950|NCT00000847|Biological|rgp120/HIV-1 SF-2|
16390951|NCT00000846|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
16390952|NCT00000846|Biological|HIV-1 Peptide Immunogen, Multivalent|
16390953|NCT00000845|Biological|P3C541b Lipopeptide|
16390954|NCT00000844|Drug|Interferon alfa-n3|
16390955|NCT00000844|Drug|Interferon alfa-n1|
16390956|NCT00000843|Drug|Adefovir dipivoxil|
16390957|NCT00000842|Drug|Nerve Growth Factor, Recombinant Human|
16390958|NCT00000841|Drug|Indinavir sulfate|
16390959|NCT00000841|Drug|Lamivudine|
16390960|NCT00000841|Drug|Stavudine|
16390961|NCT00000841|Drug|Zidovudine|
16390963|NCT00000838|Drug|Lamivudine|
16390964|NCT00000838|Drug|Stavudine|
16390965|NCT00000838|Drug|Zidovudine|
16390966|NCT00000838|Drug|Didanosine|
16390968|NCT00000836|Drug|Sevirumab|
16390974|NCT00000832|Biological|MF59|
16390975|NCT00000832|Biological|rgp120/HIV-1 SF-2|
16390976|NCT00000831|Drug|Lamivudine|
16390977|NCT00000831|Drug|Stavudine|
16390978|NCT00000831|Drug|Zidovudine|
16390979|NCT00000831|Drug|Didanosine|
16390983|NCT00000827|Drug|Anti-HIV Immune Serum Globulin (Human)|
16390990|NCT00000824|Drug|Lymphocytes, Activated|
16390997|NCT00000821|Drug|Aldesleukin|
16391000|NCT00000818|Drug|Zidovudine|
16391001|NCT00000817|Drug|Amitriptyline hydrochloride|75 mg oral tablet taken daily
16391002|NCT00000817|Drug|Amitriptyline hydrochloride placebo|Oral placebo tablet taken daily
16391003|NCT00000817|Procedure|Point acupuncture|Standardized or alternate acupuncture procedure
16391004|NCT00000816|Drug|Sulfamethoxazole-Trimethoprim|
16391010|NCT00000813|Biological|ALVAC-HIV gp160MN (vCP125)|
16391011|NCT00000813|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16391012|NCT00000813|Biological|rgp120/HIV-1 SF-2|
16391014|NCT00000811|Drug|Azithromycin|
16391015|NCT00000811|Drug|Atovaquone|
16391016|NCT00000811|Drug|Sulfamethoxazole-Trimethoprim|
16391017|NCT00000810|Drug|Delavirdine mesylate|
16391018|NCT00000810|Drug|Zidovudine|
16391019|NCT00000810|Drug|Didanosine|
16391023|NCT00000808|Drug|Nevirapine|
16391025|NCT00000806|Drug|Telinavir|
16391026|NCT00000805|Drug|Ganciclovir|
16391027|NCT00000804|Drug|Indinavir sulfate|
16391028|NCT00000803|Drug|Delavirdine mesylate|
16391029|NCT00000803|Drug|Zidovudine|
16391030|NCT00000803|Drug|Didanosine|
16391031|NCT00000802|Drug|Atovaquone|
16391032|NCT00000802|Drug|Dapsone|
16391033|NCT00000801|Drug|Filgrastim|
16391034|NCT00000801|Drug|Vincristine sulfate|
16391035|NCT00000801|Drug|Doxorubicin hydrochloride|
16391036|NCT00000801|Drug|Cyclophosphamide|
16391037|NCT00000801|Drug|Cytarabine|
16391038|NCT00000801|Drug|Dexamethasone|
16391039|NCT00000800|Drug|Methadone hydrochloride|
16391040|NCT00000800|Drug|Zidovudine|
16391041|NCT00000799|Drug|Cidofovir|
16391042|NCT00000799|Drug|Probenecid|
16391043|NCT00000798|Biological|HIV-1 Peptide Vaccine, Microparticulate Monovalent|
16391044|NCT00000796|Drug|Cycloserine|
16391045|NCT00000796|Drug|Ethionamide|
16391046|NCT00000796|Drug|Capreomycin sulfate|
16391047|NCT00000796|Drug|Aminosalicylic acid|
16391048|NCT00000796|Drug|Streptomycin sulfate|
16391049|NCT00000796|Drug|Ethambutol hydrochloride|
16391050|NCT00000796|Drug|Amikacin sulfate|
16391051|NCT00000796|Drug|Isoniazid|
16391052|NCT00000796|Drug|Pyrazinamide|
16391053|NCT00000796|Drug|Pyridoxine hydrochloride|
16391054|NCT00000796|Drug|Levofloxacin|
16391055|NCT00000796|Drug|Rifampin|
16391056|NCT00000796|Drug|Clofazimine|
16391057|NCT00000795|Biological|HIV-1 Peptide Immunogen, Multivalent|
16391066|NCT00000792|Drug|Hypericin|
16391069|NCT00000790|Drug|Thalidomide|
16391070|NCT00000789|Drug|Stavudine|
16391071|NCT00000789|Drug|Zidovudine|
16391072|NCT00000788|Drug|Methadone hydrochloride|
16391073|NCT00000788|Drug|Fluconazole|
16391074|NCT00000787|Behavioral|Pre- and post-test counseling|
16391075|NCT00000782|Biological|gp160 Vaccine (Immuno-AG)|
16391076|NCT00000782|Biological|gp160 Vaccine (MicroGeneSys)|
16391077|NCT00000781|Drug|Nevirapine|
16391078|NCT00000781|Drug|Zidovudine|
16391079|NCT00000781|Drug|Zalcitabine|
16391080|NCT00000781|Drug|Didanosine|
16391081|NCT00000779|Biological|Aluminum hydroxide|
16391082|NCT00000779|Biological|MF59|
16391083|NCT00000779|Biological|rgp120/HIV-1IIIB|
16391084|NCT00000779|Biological|rgp120/HIV-1MN|
16391085|NCT00000779|Biological|rgp120/HIV-1 SF-2|
16391086|NCT00000779|Biological|Env 2-3|
16391087|NCT00000778|Drug|Isoniazid|
16391088|NCT00000778|Drug|Pyridoxine hydrochloride|
16391089|NCT00000778|Drug|Levofloxacin|
16391095|NCT00000775|Biological|rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine|
16391096|NCT00000774|Biological|rgp120/HIV-1MN|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
16391097|NCT00000774|Biological|rgp120/HIV-1 SF-2|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
16391098|NCT00000774|Biological|Placebo version of rgp120/HIV-1MN|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
16391099|NCT00000774|Biological|Placebo version of rgp120/HIV-1SF2|Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
16391103|NCT00000771|Drug|Paromomycin sulfate|
16391104|NCT00000770|Drug|Nevirapine|
16391105|NCT00000770|Drug|Zidovudine|
16391106|NCT00000770|Drug|Didanosine|
16391108|NCT00000768|Drug|Glutamic acid hydrochloride|
16391109|NCT00000768|Drug|Ganciclovir|
16391112|NCT00000766|Drug|Foscarnet sodium|
16391113|NCT00000766|Drug|Ganciclovir|
16391117|NCT00000763|Drug|TNP-470|
16391118|NCT00000762|Biological|rgp120/HIV-1MN|
16391119|NCT00000762|Biological|rgp120/HIV-1 SF-2|
16391120|NCT00000762|Biological|gp160 Vaccine (MicroGeneSys)|
16391121|NCT00000761|Drug|Interferon gamma-1b|
16391122|NCT00000760|Drug|Ro 24-7429|
16391123|NCT00000760|Drug|Zidovudine|
16391124|NCT00000760|Drug|Didanosine|
16391125|NCT00000758|Drug|Fluorouracil|
16391126|NCT00000757|Biological|gp160 Vaccine (MicroGeneSys)|
16391127|NCT00000756|Drug|Lymphocytes, Activated|
16391128|NCT00000755|Biological|rgp120/HIV-1MN|
16391129|NCT00000755|Drug|Zidovudine|
16391130|NCT00000754|Drug|Interferon alfa-2a|
16391131|NCT00000754|Drug|Zidovudine|
16391132|NCT00000754|Drug|Zalcitabine|
16391133|NCT00000753|Drug|Atevirdine mesylate|
16391134|NCT00000753|Drug|Zidovudine|
16391135|NCT00000753|Drug|Zalcitabine|
16391136|NCT00000753|Drug|Didanosine|
16391141|NCT00000751|Drug|Anti-HIV Immune Serum Globulin (Human)|
16391142|NCT00000751|Drug|Globulin, Immune|
16391143|NCT00000751|Drug|Zidovudine|
16391145|NCT00000749|Biological|rgp120/HIV-1 SF-2|
16391146|NCT00000748|Drug|Sulfamethoxazole-Trimethoprim|
16391147|NCT00000747|Drug|Nevirapine|
16391148|NCT00000746|Biological|rgp120/HIV-1 SF-2|
16391149|NCT00000746|Biological|Env 2-3|
16391150|NCT00000746|Biological|HIVAC-1e|
16391151|NCT00000746|Biological|gp160 Vaccine (MicroGeneSys)|
16391152|NCT00000745|Biological|Hepatitis B Vaccine (Recombinant)|
16391153|NCT00000745|Biological|gp160 Vaccine (MicroGeneSys)|
16391154|NCT00000744|Drug|Fluconazole|
16391157|NCT00000742|Drug|Atevirdine mesylate|
16391158|NCT00000742|Drug|Zidovudine|
16391159|NCT00000742|Drug|Didanosine|
16391160|NCT00000741|Drug|Methylprednisolone|
16391161|NCT00000740|Drug|Sitamaquine|
16391162|NCT00000739|Drug|Dapsone|
16391163|NCT00000738|Drug|Nimodipine|
16391164|NCT00000738|Drug|Zidovudine|
16391165|NCT00000737|Drug|Dronabinol|
16391166|NCT00000737|Drug|Megestrol acetate|
16391167|NCT00000736|Drug|Zidovudine|
16391168|NCT00000735|Drug|Ampligen|
16391171|NCT00000733|Drug|Ribavirin|
16391172|NCT00000732|Drug|Sulfamethoxazole-Trimethoprim|
16391173|NCT00000732|Drug|Zidovudine|
16391174|NCT00000731|Drug|Zidovudine|
16391175|NCT00000731|Drug|Acetaminophen|
16391176|NCT00000730|Drug|Trimetrexate glucuronate|
16391177|NCT00000730|Drug|Methylprednisolone|
16391178|NCT00000730|Drug|Pentamidine isethionate|
16391179|NCT00000730|Drug|Sulfamethoxazole-Trimethoprim|
16391180|NCT00000730|Drug|Leucovorin calcium|
16391181|NCT00000729|Drug|Foscarnet sodium|
16391182|NCT00000728|Drug|Zidovudine|
16391183|NCT00000728|Drug|Aldesleukin|
16391184|NCT00000727|Drug|Pentamidine isethionate|
16391185|NCT00000727|Drug|Pyrimethamine|
16391186|NCT00000727|Drug|Sulfamethoxazole/Trimethoprim|
16391187|NCT00000727|Drug|Sulfadoxine/Pyrimethamine|
16391188|NCT00000727|Drug|Zidovudine|
16391189|NCT00000726|Drug|Foscarnet sodium|
16391190|NCT00000725|Drug|Interferon alfa-2a|
16391191|NCT00000725|Drug|Zidovudine|
16391192|NCT00000725|Drug|Interferon alfa-n1|
16391193|NCT00000724|Drug|Trimetrexate glucuronate|
16391194|NCT00000724|Drug|Leucovorin calcium|
16391199|NCT00000722|Drug|Pentamidine isethionate|
16391201|NCT00000720|Drug|Globulin, Immune|
16391202|NCT00000720|Drug|Zidovudine|
16391203|NCT00000719|Drug|Zidovudine|
16391204|NCT00000719|Drug|Zalcitabine|
16391205|NCT00000718|Drug|Zidovudine|
16391206|NCT00000718|Drug|Zalcitabine|
16391207|NCT00000717|Drug|Primaquine|
16391208|NCT00000717|Drug|Clindamycin|
16391209|NCT00000716|Drug|Zidovudine|
16391210|NCT00000715|Drug|Pentamidine isethionate|
16391211|NCT00000715|Drug|Sulfamethoxazole-Trimethoprim|
16391214|NCT00000713|Drug|Ampligen|
16391215|NCT00000712|Drug|Zidovudine|
16391216|NCT00000712|Drug|Acyclovir|
16391217|NCT00000711|Drug|Zidovudine|
16391218|NCT00000711|Drug|Sargramostim|
16391219|NCT00000710|Drug|Didanosine|
16391221|NCT00000708|Drug|Flucytosine|
16391222|NCT00000708|Drug|Fluconazole|
16391223|NCT00000708|Drug|Amphotericin B|
16391224|NCT00000707|Drug|Pentamidine isethionate|
16391225|NCT00000706|Drug|Quinine sulfate|
16391226|NCT00000706|Drug|Probenecid|
16391227|NCT00000706|Drug|Zidovudine|
16391229|NCT00000704|Drug|Zalcitabine|
16391230|NCT00000703|Drug|Bleomycin sulfate|
16391231|NCT00000703|Drug|Vincristine sulfate|
16391232|NCT00000703|Drug|Doxorubicin hydrochloride|
16391233|NCT00000703|Drug|Cyclophosphamide|
16391234|NCT00000703|Drug|Allopurinol|
16391235|NCT00000703|Drug|Methotrexate|
16391236|NCT00000703|Drug|Cytarabine|
16391237|NCT00000703|Drug|Leucovorin calcium|
16391238|NCT00000703|Drug|Zidovudine|
16391239|NCT00000703|Drug|Dexamethasone|
16391240|NCT00000702|Drug|Zidovudine|
16391241|NCT00000701|Drug|Zidovudine|
16391242|NCT00000700|Drug|Zidovudine|
16391243|NCT00000699|Drug|Inosine pranobex|
16391244|NCT00000699|Drug|Ribavirin|
16391245|NCT00000698|Drug|Ganciclovir|
16391246|NCT00000697|Drug|Foscarnet sodium|
16391247|NCT00000696|Drug|Interferon alfa-2a|
16391248|NCT00000696|Drug|Zidovudine|
16391249|NCT00000695|Drug|Interferon beta-1b|
16391250|NCT00000695|Drug|Zidovudine|
16391251|NCT00000694|Drug|Interferon alfa-2b|
16391252|NCT00000694|Drug|Zidovudine|
16391253|NCT00000694|Drug|Sargramostim|
16391254|NCT00000693|Drug|Zidovudine|
16391255|NCT00000693|Drug|Acyclovir|
16391256|NCT00000692|Drug|Butyldeoxynojirimycin|
16391257|NCT00000691|Drug|Foscarnet sodium|
16391258|NCT00000690|Drug|Dextran sulfate|
16391259|NCT00000689|Drug|Bleomycin sulfate|
16391260|NCT00000689|Drug|Vincristine sulfate|
16391261|NCT00000689|Drug|Doxorubicin hydrochloride|
16391262|NCT00000689|Drug|Cyclophosphamide|
16391263|NCT00000689|Drug|Methotrexate|
16391264|NCT00000689|Drug|Cytarabine|
16391265|NCT00000689|Drug|Leucovorin calcium|
16391266|NCT00000689|Drug|Sargramostim|
16391267|NCT00000689|Drug|Dexamethasone|
16391268|NCT00000688|Drug|Ganciclovir|
16391269|NCT00000687|Drug|Interferon alfa-2a|
16391270|NCT00000687|Drug|Zidovudine|
16391271|NCT00000686|Drug|Stavudine|
16391272|NCT00000685|Drug|Zidovudine|
16391273|NCT00000684|Drug|Dextran sulfate|
16391274|NCT00000683|Biological|HIVAC-1e|
16391275|NCT00000683|Biological|gp160 Vaccine (MicroGeneSys)|
16391276|NCT00000682|Drug|Zidovudine|
16391277|NCT00000682|Drug|Zalcitabine|
16391278|NCT00000681|Drug|Bleomycin sulfate|
16391279|NCT00000681|Drug|Vincristine sulfate|
16391280|NCT00000681|Drug|Doxorubicin hydrochloride|
16391281|NCT00000681|Drug|Zidovudine|
16391282|NCT00000681|Drug|Sargramostim|
16391283|NCT00000680|Drug|Zidovudine|
16391284|NCT00000680|Drug|Aldesleukin|
16391285|NCT00000679|Drug|Zidovudine|
16391286|NCT00000679|Drug|Zalcitabine|
16391287|NCT00000678|Drug|Zidovudine|
16391288|NCT00000678|Drug|Zalcitabine|
16391289|NCT00000677|Drug|SCH 39304|
16391290|NCT00000676|Drug|Clotrimazole|
16391291|NCT00000676|Drug|Fluconazole|
16391292|NCT00000675|Drug|CD4-IgG|
16391293|NCT00000674|Drug|Pyrimethamine|
16391294|NCT00000674|Drug|Leucovorin calcium|
16391295|NCT00000674|Drug|Clindamycin|
16391297|NCT00000672|Drug|Didanosine|
16391298|NCT00000671|Drug|Zidovudine|
16391299|NCT00000671|Drug|Didanosine|
16391300|NCT00000670|Drug|Probenecid|
16391301|NCT00000670|Drug|Zidovudine|
16391302|NCT00000669|Drug|Didanosine|
16391303|NCT00000668|Drug|Ganciclovir|
16391304|NCT00000667|Biological|gp160 Vaccine (MicroGeneSys)|
16391305|NCT00000666|Drug|Pyrimethamine|
16391306|NCT00000665|Drug|Foscarnet sodium|
16391307|NCT00000665|Drug|Ganciclovir|
16391308|NCT00000664|Drug|Interleukin-2, Polyethylene Glycolated|
16391309|NCT00000664|Drug|Zidovudine|
16391310|NCT00000663|Drug|CD4-IgG|
16391311|NCT00000662|Drug|Zidovudine|
16391312|NCT00000661|Drug|Oxazepam|
16391313|NCT00000661|Drug|Zidovudine|
16391314|NCT00000660|Drug|Etoposide|
16391315|NCT00000659|Drug|CD4 Antigens|
16391316|NCT00000659|Drug|Zidovudine|
16391317|NCT00000658|Drug|Bleomycin sulfate|
16391318|NCT00000658|Drug|Vincristine sulfate|
16391319|NCT00000658|Drug|Doxorubicin hydrochloride|
16391320|NCT00000658|Drug|Cyclophosphamide|
16391321|NCT00000658|Drug|Allopurinol|
16391322|NCT00000658|Drug|Methotrexate|
16391323|NCT00000658|Drug|Cytarabine|
16391324|NCT00000658|Drug|Leucovorin calcium|
16391325|NCT00000658|Drug|Sargramostim|
16391326|NCT00000658|Drug|Dexamethasone|
16391327|NCT00000657|Drug|Zidovudine|
16391328|NCT00000657|Drug|Didanosine|
16391329|NCT00000656|Drug|Zidovudine|
16391330|NCT00000656|Drug|Didanosine|
16391331|NCT00000655|Drug|Atovaquone|
16391332|NCT00000655|Drug|Sulfamethoxazole-Trimethoprim|
16391333|NCT00000654|Drug|Fialuridine|
16391335|NCT00000652|Drug|Zidovudine|
16391336|NCT00000652|Drug|Didanosine|
16391337|NCT00000651|Drug|Zidovudine|
16391338|NCT00000651|Drug|Zalcitabine|
16391340|NCT00000649|Drug|Nevirapine|
16391341|NCT00000649|Drug|Zidovudine|
16391349|NCT00000646|Drug|Pentoxifylline|
16391350|NCT00000645|Drug|Hypericin|
16391351|NCT00000644|Drug|Clarithromycin|
16391352|NCT00000643|Drug|Pyrimethamine|
16391353|NCT00000643|Drug|Leucovorin calcium|
16391354|NCT00000642|Drug|CD4-IgG|
16391355|NCT00000641|Drug|Ciprofloxacin hydrochloride|
16391356|NCT00000641|Drug|Ethambutol hydrochloride|
16391357|NCT00000641|Drug|Amikacin sulfate|
16391358|NCT00000641|Drug|Azithromycin|
16391359|NCT00000641|Drug|Rifampin|
16391360|NCT00000641|Drug|Clofazimine|
16391361|NCT00000640|Drug|Primaquine|
16391362|NCT00000640|Drug|Sulfamethoxazole-Trimethoprim|
16391363|NCT00000640|Drug|Dapsone|
16391364|NCT00000640|Drug|Clindamycin|
16391365|NCT00000639|Drug|Itraconazole|
16391366|NCT00000639|Drug|Flucytosine|
16391367|NCT00000639|Drug|Fluconazole|
16391368|NCT00000639|Drug|Amphotericin B|
16391369|NCT00000638|Drug|Isoniazid|
16391370|NCT00000638|Drug|Pyrazinamide|
16391371|NCT00000638|Drug|Pyridoxine hydrochloride|
16391372|NCT00000638|Drug|Rifampin|
16391373|NCT00000637|Drug|Zidovudine|
16391374|NCT00000637|Drug|Didanosine|
16391375|NCT00000636|Drug|Isoniazid|
16391376|NCT00000636|Drug|Pyrazinamide|
16391377|NCT00000636|Drug|Pyridoxine hydrochloride|
16391378|NCT00000636|Drug|Rifampin|
16391379|NCT00000635|Drug|Trifluridine|
16391380|NCT00000635|Drug|Bacitracin zinc/Polymyxin B sulfate|
16391381|NCT00000634|Drug|Nevirapine|
16391382|NCT00000633|Biological|gp160 Vaccine (Immuno-AG)|
16391383|NCT00000633|Biological|Hepatitis B Vaccine (Recombinant)|
16391384|NCT00000632|Biological|Env 2-3|
16391385|NCT00000631|Biological|HIVAC-1e|
16391386|NCT00000631|Biological|gp160 Vaccine (MicroGeneSys)|
16391389|NCT00000629|Drug|Valproic acid|
16391390|NCT00000629|Drug|Zidovudine|
16391391|NCT00000628|Drug|L-697,661|
16391392|NCT00000628|Drug|Zidovudine|
16391393|NCT00000627|Drug|Fluconazole|
16391399|NCT00000625|Drug|Zidovudine|
16391400|NCT00000625|Drug|Zalcitabine|
16391401|NCT00000625|Drug|Didanosine|
16391402|NCT00023192|Drug|T-Cell Depleted & CD34+Select/w/StemCell Enriched Product|
16391403|NCT00023166|Drug|PEG-paclitaxel|
16391404|NCT00023153|Drug|Adefovir Dipivoxil|
16391405|NCT00023127|Procedure|Integrated Pest Management|
16391406|NCT00022971|Biological|Apolizumab|Apolizumab IV on Day 1. Administer weekly for 4 weeks
16391407|NCT00022971|Biological|Rituximab|Rituximab IV 24-36 hours after Apolizumab ends. Administer weekly for 4 weeks
16391408|NCT00022958|Drug|Iodine-131 Anti-B1 Antibody|
16391409|NCT00022945|Drug|Iodine-131 Anti-B1 Antibody|
16391410|NCT00022945|Drug|Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP)|
16391411|NCT00022932|Drug|Iodine-131 Anti-B1 Antibody|
16391412|NCT00022906|Drug|Iodine-131 Anti-B1 Antibody|
16391413|NCT00022893|Drug|Iodine-131 Anti-B1 Antibody|
16391414|NCT00022880|Drug|Iodine-131 Anti-B1 Antibody|
16391415|NCT00022867|Drug|Nondigestible oligosaccharide (NDO)|
16391416|NCT00022854|Procedure|Single-injection femoral nerve block|Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
16391417|NCT00022854|Procedure|Femoral nerve block 60-hour continuous injection|Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
16391418|NCT00022854|Procedure|Saline (control) injection into femoral nerve envelope|Nerve block bolus with 30 mL saline, followed by continuous saline infusion
16391419|NCT00022841|Drug|Pamidronate|
16391420|NCT00022828|Device|3-D Laser Imaging Device|
16391421|NCT00022815|Device|Tissue ultrafiltration|
16391422|NCT00022802|Device|Image-guided surgical system|
16391423|NCT00022776|Procedure|Surgical decompression|Simple decompression not requiring fusion.
16391424|NCT00022776|Procedure|Physical therapy|2 physical therapy sessions per week for 6 weeks Followed by home program.
16391425|NCT00022750|Behavioral|Nurse Case Manager and Community Health Worker Team|
16391426|NCT00021866|Behavioral|Differential Abilities Scale|IQ measurement at 3, 4.5 and 6 years of age
16391427|NCT00021866|Behavioral|Neuropsychological Testing|Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
16391428|NCT00021853|Behavioral|constraint-induced movement therapy|
16391429|NCT00021827|Drug|Parathyroid hormone-related protein or ''PTHrP''|
16391430|NCT00021814|Drug|Doxazosin|
16391431|NCT00021814|Drug|Finasteride|
16391432|NCT00021814|Drug|Doxazosin placebo|
16391433|NCT00021814|Drug|Finasteride placebo|
16391434|NCT00021801|Procedure|Islet Cell Transplantation|
16391435|NCT00021788|Procedure|islet cell transplantation|
16391436|NCT00021749|Drug|Oblimerson sodium, G3139|
16391437|NCT00021736|Drug|EYE001 anti-VEGF aptamer|
16391438|NCT00021723|Biological|AN-1792 also known as AIP-001|
16391439|NCT00021697|Drug|AVP-923|
16391440|NCT00021658|Procedure|Pesticide application procedures|
16391441|NCT00021645|Drug|Vitamin E|
16391442|NCT00021580|Procedure|human cadaveric islet cell transplantation|
16391443|NCT00021567|Drug|Interferon Gamma for Aerosol|
16391444|NCT00021541|Drug|tipifarnib|Given orally, 200 mg/m^2/dose BSA every 12 hours by mouth (po) daily x 21 days, Course is every 28 days
16391445|NCT00021541|Other|placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.
16391446|NCT00021528|Drug|citalopram|
16391447|NCT00021528|Drug|BuproprionSR|
16391448|NCT00021528|Drug|buspirone|
16391449|NCT00021528|Drug|Lithium|
16391450|NCT00021528|Drug|mirtazapine|
16391451|NCT00021528|Drug|nortriptyline|
16391452|NCT00021528|Drug|sertraline|
16391453|NCT00021528|Drug|tranylcypromine|
16391454|NCT00021528|Drug|VenlafaxineXR|
16391455|NCT00021528|Behavioral|Cognitive Therapy|
16391456|NCT00021528|Drug|T3 (Triiodothyronine)|
16391457|NCT00021502|Drug|pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)|
16391458|NCT00021476|Behavioral|Behavioral treatments|
16391459|NCT00021476|Behavioral|Physical therapy|
16391460|NCT00018902|Drug|Fluoxetine|Standard anti-depressant treatment with the SSRI fluoxetine
16391461|NCT00018902|Drug|Venlafaxine|Standard antidepressant treatment with the non-SSRI medication venlafaxine
16391462|NCT00018902|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT addresses maladaptive beliefs in order to encourage behavioral change
16391463|NCT00018902|Drug|Citalopram|Standard anti-depressant treatment with the SSRI fluoxetine
16391464|NCT00018876|Procedure|Lumbar nerve root decompression|
16391465|NCT00018876|Procedure|Preoperative low-dose external beam radiation|
16391466|NCT00018863|Drug|Methylphenidate|
16391467|NCT00018850|Drug|ondansetron|
16391468|NCT00018850|Behavioral|neuropsychological testing|
16391469|NCT00018850|Drug|nicotine|
16391470|NCT00018850|Drug|haloperidol|
16391471|NCT00018837|Behavioral|Community Re-Entry Program: What is Schizophrenia|
16391472|NCT00018824|Drug|NALTREXONE|
16391473|NCT00018824|Drug|Placebo|
16391474|NCT00018811|Behavioral|Relaxation training & thermal biofeedback|
16391475|NCT00018811|Behavioral|Surface EMG biofeedback|
16391476|NCT00018785|Procedure|donor bone marrow infusion|
16391477|NCT00018759|Drug|paroxetine|
16391478|NCT00018759|Behavioral|ongoing psychological screening|
16391479|NCT00018746|Device|repetitive transcranial magnetic stimulation|
16391480|NCT00018733|Drug|paroxetine|
16391481|NCT00018733|Drug|Desipramine|
16391482|NCT00018694|Drug|Chenodeoxycholic Acid|
16391483|NCT00018668|Drug|Risperidone|
16391484|NCT00018668|Drug|Olanzapine|
16391485|NCT00018668|Drug|Quetiapine|
16391486|NCT00018655|Behavioral|Twelve Step Facilitation|Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
16391487|NCT00018655|Behavioral|Integrated Cognitive Behavioral Treatment|Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.
16391488|NCT00018642|Drug|quetiapine|
16391489|NCT00018642|Drug|haloperidol decanoate|
16391490|NCT00018616|Behavioral|MEMS caps|
16391491|NCT00018603|Drug|guanfacine|
16391492|NCT00018564|Drug|treatments for essential tremor|
16391493|NCT00018551|Drug|Folic Acid|
16391494|NCT00018538|Drug|calcifidiol|
16391495|NCT00018525|Procedure|Lung Volume Reduction Surgery|
16391496|NCT00018512|Procedure|Implant-supported denture|
16391497|NCT00018460|Drug|Vitamin B|
16391498|NCT00018447|Drug|PTH 1-34|
16391499|NCT00018447|Drug|MFPSR-fluoride|
16391500|NCT00018421|Procedure|Treadmill Exercise|
16391501|NCT00018382|Drug|rosiglitazone|
16391502|NCT00018356|Procedure|exercise|
16391503|NCT00018356|Drug|testosterone|
16391504|NCT00018343|Drug|estrogen|
16391505|NCT00018330|Behavioral|Weight Loss|
16391506|NCT00018317|Behavioral|low protein diet|
16391507|NCT00018317|Behavioral|resistance training|
16391508|NCT00018317|Behavioral|combination of diet control and exercise|
16391509|NCT00018291|Drug|Risperidone|
16391510|NCT00018291|Drug|Gabapentin|
16391511|NCT00018278|Drug|Aricept|
16391512|NCT00018278|Drug|Exelon|
16391513|NCT00018278|Drug|Nicoderm Patch|
16391514|NCT00018265|Behavioral|Task specific endurance training|
16391515|NCT00018265|Behavioral|Tai Chi|
16391516|NCT00018252|Behavioral|exercise|
16391517|NCT00018239|Procedure|Exercise|
16391518|NCT00018226|Behavioral|Case Management|
16391519|NCT00018213|Drug|Naltrexone Hydrochloride|
16391520|NCT00018213|Drug|Transdermal Nicotine|
16391521|NCT00018200|Drug|Desipramine|Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
16391522|NCT00018200|Drug|Fluoxetine|Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
16391523|NCT00018200|Drug|Benztropine|Daily dose 0.125 to 0.5mg
16391524|NCT00018187|Drug|Bupropion|
16391525|NCT00018187|Drug|Mecamylamine|
16391526|NCT00018187|Drug|Nicotine Patch|
16391527|NCT00018174|Drug|Fluoxetine|
16391528|NCT00018174|Behavioral|Behavioral group smoking cessation treatment|
16391529|NCT00018174|Drug|Placebo|
16391530|NCT00018161|Drug|Mecamylamine|
16391531|NCT00018161|Drug|Nicotine Patch|
16391532|NCT00018161|Behavioral|Cigarette brand switching|
16391533|NCT00018148|Drug|nortriptyline|Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg
16391534|NCT00018148|Drug|transdermal nicotine|Transdermal nicotine 21 mg, titrated down plus placebo
16391535|NCT00018135|Drug|calcium acetate|
16391536|NCT00018135|Drug|aluminum hydroxide|
16391537|NCT00018135|Drug|Sevelamer|
16391538|NCT00018109|Drug|glutamine|
16391539|NCT00018109|Drug|creatine monohydrate|
16391540|NCT00018096|Biological|LPS endotoxin, saline, HDM|instillation of interventional products during bronchoscopy each down a different airway, each subject acts as their own control.
16391541|NCT00018083|Drug|rifabutin|
16391542|NCT00018083|Drug|isoniazid|
16391543|NCT00018083|Drug|efavirenz|
16391544|NCT00018070|Procedure|Angiography|
16391545|NCT00018070|Procedure|Laser Treatment|
16391546|NCT00018057|Behavioral|Attention Bias Modification Training|The intervention is computer-based. The active and control treatments have two components. In one component of the active intervention, subjects are asked to indicate the identity of a letter that appears behind a neutral face, opposite from an angry face. In another component of the active intervention, subjects are asked to identify numbers that are hidden within a puzzle, in locations distal from angry faces. In both components of the active intervention, subjects implicitly learn to shift their attention away from angry faces. This is because the faces are systematically arranged to be far removed from letters and numbers that need to be identified. The control arm of the intervention involves similar components. However, unlike in the intervention arm, angry faces appear in various locations near letters and numbers. Therefore, attention is not shaped in the control arm. This intervention requires five minutes per session and is administered before weekly psychotherapy sessions.
16391547|NCT00018057|Drug|Fluoxetine|Randomized assignment.
16391548|NCT00018031|Drug|Peginterferon alfa-2b|Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously
16391549|NCT00018031|Drug|Ribavirin|Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.
16391550|NCT00018018|Drug|CD34+ cells transduced with ADA retrovir|
16391551|NCT00018005|Behavioral|Self-Management|18 in-person group sessions providing self-management training.
16391552|NCT00018005|Other|attention control|18 educational mailings follow by a a telephone call.
16391553|NCT00017940|Genetic|Human Nerve Growth Factor|
16391556|NCT00017927|Drug|Pegvisomant|
16391557|NCT00017823|Procedure|Acupressure|
16391558|NCT00017810|Behavioral|Dietary intervention|"The dietary intervention focused on diarrhea management using skill-building techniques that provided subjects with knowledge and a sense of confidence about making food choices.
~Behavioral dietary intervention (Condition 1: treatment) - a low-fat, lactose-free, low insoluble fiber, high soluble fiber, and caffeine-free diet based on normal foods"
16391559|NCT00017810|Behavioral|HIV Self-Care|Standard information regarding self-care and healthy living with HIV - focused on healthy living with HIV and did not include dietary restrictions or dietary information that could affect bowel movements.
16391560|NCT00017706|Behavioral|physician-delivered weight control|
16391561|NCT00016835|Procedure|Supra-gingival scaling and placebo|Included in arm/group description.
16391562|NCT00016835|Procedure|Subgingival scaling and metronidazole|Included in arm/group description.
16391563|NCT00016835|Procedure|Subgingival scaling and doxycycline|Included in arm/group description.
16391564|NCT00017680|Drug|Melphalan|100 mg/m2 twice a day from Days -2 and -1 as induction therapy
16391565|NCT00017680|Procedure|Autologous Stem Cell Transplantation|Bone marrow and peripheral blood stem cells harvested
16391566|NCT00017654|Drug|anti-thymocyte globulin|
16391567|NCT00017654|Drug|cyclophosphamide|
16391568|NCT00017654|Drug|cyclosporine|
16391569|NCT00017654|Drug|methylprednisolone|
16391570|NCT00017654|Procedure|Allogeneic Bone Marrow Transplantation|
16391571|NCT00017641|Drug|anti-thymocyte globulin|
16391572|NCT00017641|Drug|cyclophosphamide|
16391573|NCT00017641|Drug|filgrastim|
16391574|NCT00017641|Procedure|CD34+ Peripheral Blood Stem Cell Reinfusion|
16391575|NCT00017628|Drug|cyclophosphamide|
16391576|NCT00017628|Drug|filgrastim|
16391577|NCT00017628|Drug|methylprednisolone|
16391578|NCT00017628|Procedure|Autologous Stem Cell Transplantation|
16391579|NCT00016744|Drug|Sodium 4-Phenylbutyrate (4PBA)|The standard oral adult dose is 20g/day (tablets) for 4 days.
16391580|NCT00016744|Drug|Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein)|Every participant will be administered a perfusion of 50 MicroM of Genistein during the modified NPD procedure.
16391581|NCT00016744|Drug|Placebo|The placebo dose will match the oral tablets in arm 1, maintaining the study blind.
16391582|NCT00016679|Drug|1-Octanol|
16391583|NCT00016666|Drug|Propranolol|
16391584|NCT00016653|Drug|Creatine Monohydrate|
16391585|NCT00016653|Drug|Glutamine|
16391586|NCT00016549|Biological|Bevacizumab|
16391587|NCT00016523|Drug|Inhaled nitric oxide|Started at 5 ppm and could be increased to 10 ppm
16391588|NCT00016523|Drug|Placebo|Started at 5 ppm and could be increased to 10 ppm
16391589|NCT00016497|Procedure|bilateral myringotomy|
16391590|NCT00016497|Procedure|bilateral myringotomy and tubes|
16391591|NCT00016497|Procedure|adenoidectomy|
16391592|NCT00016471|Procedure|Audiogram|
16391593|NCT00016471|Procedure|Electroretinogram|
16391594|NCT00016458|Drug|anti-thymocyte globulin|
16391595|NCT00016458|Drug|cyclophosphamide|
16391596|NCT00016445|Drug|growth hormone|
16391597|NCT00015808|Drug|Idebenone|
16391598|NCT00015795|Device|airway interruption test|
16391599|NCT00015769|Drug|levetiracetam|
16391600|NCT00015665|Drug|Voriconazole|
16391601|NCT00015626|Drug|Metformin|
16391602|NCT00015626|Procedure|skin biopsy|
16391603|NCT00015626|Behavioral|diet and exercise|
16391604|NCT00015626|Drug|pioglitazone|
16391605|NCT00015626|Drug|rosiglitazone|
16391606|NCT00015600|Behavioral|Behavior modification through social marketing|
16391607|NCT00015548|Drug|Olanzapine|
16391608|NCT00015548|Drug|Quetiapine|
16391609|NCT00015548|Drug|Risperidone|
16391610|NCT00015548|Drug|Citalopram|
16391611|NCT00015457|Drug|Amlodipine plus Botulinum toxin|
16391612|NCT00015015|Drug|Dichloroacetate|
16391613|NCT00015340|Drug|Buprenorphine/naloxone|
16391614|NCT00015301|Drug|Methylphenidate|
16391615|NCT00015288|Drug|Buprenorphine/naloxone|
16391616|NCT00015275|Behavioral|Cocaine-Related Disorders|
16391617|NCT00015249|Drug|Amantadine|
16391618|NCT00015236|Behavioral|Amantadine|
16391619|NCT00015223|Drug|Methylphenidate|
16391620|NCT00015210|Drug|Nefazodone|
16391621|NCT00015210|Behavioral|Psychosocial Treatment|All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
16391622|NCT00015171|Drug|Buprenorphine/naloxone|
16391623|NCT00015132|Drug|Sertraline|
16391624|NCT00015106|Drug|Lamotrigine|
16391625|NCT00015080|Drug|Naltrexone|
16391626|NCT00015067|Drug|Methylphenidate|
16391627|NCT00015054|Drug|Methylphenidate|
16391628|NCT00015041|Drug|Buprenorphine|
16391629|NCT00015028|Drug|Buprenorphine/naloxone|
16391630|NCT00015002|Drug|Betamethasone|"coded study medication is 12 mg of betamethasone (or placebo) given as 2 ml intramuscular injection in 2 doses, 24 hours apart (the Course). Patients administered weekly courses for 4 weeks, until 33 weeks 6 days gestation or delivery, whichever occurs first."
16391631|NCT00014989|Drug|magnesium sulfate|
16391632|NCT00014950|Procedure|CF newborn screening|
16391633|NCT00014833|Other|No intervention|No intervention
16391634|NCT00014807|Behavioral|Reducing Pesticide Exposure in Minority Families|
16391635|NCT00014794|Drug|15-O labeled water|
16391636|NCT00014768|Drug|glucose|
16391637|NCT00014768|Drug|insulin|
16391638|NCT00014768|Drug|leucine|
16391639|NCT00014755|Drug|anti-thymocyte globulin|
16391640|NCT00014755|Drug|cyclophosphamide|
16391641|NCT00014755|Drug|filgrastim|
16391642|NCT00014755|Drug|prednisone|
16391643|NCT00014755|Procedure|peripheral blood stem cell transplantation|
16391644|NCT00014755|Procedure|irradiation|
16391645|NCT00014742|Drug|collagenase|
16391646|NCT00014729|Drug|isotretinoin|
16391647|NCT00014040|Drug|Nitric Oxide and INOpulse Delivery System|
16391648|NCT00014027|Drug|Docosahexaenoic acid (DHA)|
16391649|NCT00014027|Drug|Eicosapentaenoic acid|
16391650|NCT00014001|Drug|perphenazine|
16391651|NCT00014001|Drug|olanzapine|
16391652|NCT00014001|Drug|quetiapine|
16391653|NCT00014001|Drug|risperidone|
16391654|NCT00014001|Drug|ziprasidone|
16391655|NCT00014001|Drug|clozapine|
16391656|NCT00014001|Drug|fluphenazine decanoate|
16391657|NCT00013962|Drug|Vitamin D|
16391658|NCT00013923|Drug|Nutritional Supplement|
16391659|NCT00013910|Drug|NNC 90-1170|
16391660|NCT00013884|Drug|T-20|
16391661|NCT00013806|Drug|131I-MIBG|
16391662|NCT00013793|Behavioral|Motivational enhancement and ultrasound|
16391663|NCT00013767|Behavioral|Individual and Community education|
16391664|NCT00013741|Behavioral|Tailored Education Messages|
16391665|NCT00013702|Drug|Adefovir|
16391666|NCT00013689|Drug|Fansidar (pyrimethamine and sulfadoxine)|
16391667|NCT00013650|Drug|Cyclophosphamate|
16391668|NCT00013624|Drug|IV Levodopa|
16391669|NCT00013611|Drug|Proleukin|Recombinant IL-2 was given at a dose of 4.5 MIU twice daily subcutaneously for 5 consecutive days every 8 weeks, in addition to antiretroviral therapy, for 6 cycles. After the first 6 cycles, additional cycles were given to either achieve or maintain the patient's CD4+ cell count goal.
16391670|NCT00013598|Drug|Pioglitazone|
16391671|NCT00013546|Drug|TMTDS|
16391672|NCT00013533|Procedure|Stem cell transplantation|>3 x 106/kg CD34+ stem cells by IV infusion
16391673|NCT00013507|Procedure|Falls|
16391674|NCT00013494|Procedure|Stroke Rehabilitation|
16391675|NCT00013481|Procedure|Stroke Rehabilitation|
16391676|NCT00013468|Procedure|Tinnitus|
16391677|NCT00013455|Device|Hearing|
16391678|NCT00013442|Procedure|Auditory Evoked Response|
16391679|NCT00013429|Procedure|Visual|
16391680|NCT00013416|Procedure|Hearing|
16391681|NCT00013403|Procedure|Blindness|
16391682|NCT00013390|Procedure|Tinnitus Masking|"Tinnitus Masking is a widely-used method for providing relief of tinnitus. The central premise of Tinnitus Masking involves the use of wearable ear-level devices (hearing aids, maskers, or combination instruments) that deliver sound to a patient's ear(s). The primary purpose of the sound presentation is to produce a sense of relief from the annoyance caused by the tinnitus sound. The relief is accomplished by either obscuring, or covering up (masking) the tinnitus sound, or by changing the sound of the tinnitus in some way, usually by reducing its loudness (Vernon, Meikle)."
16391683|NCT00013390|Procedure|Tinnitus Retraining Therapy|"Tinnitus Retraining Therapy (TRT) was derived from a purely psychological approach for facilitating tinnitus habituation (Hallam et al). The current method is based on neurophysiological principles, and aims at retraining brain regions that are involved in processing the tinnitus signal, without attempting to suppress generation of the signal (Jastreboff). The retraining involves a systematic effort aimed at decreasing both the detectability of tinnitus and the transmission of the tinnitus signal to emotional centers of the brain. Habituation of tinnitus thus purportedly occurs at two levels: habituation of emotional reactions to the tinnitus and habituation of tinnitus perception. Habituation is achieved by utilizing directive counseling, along with the use of low-level broadband noise to reduce the detectability of tinnitus for patients with normal or near-normal hearing. When hearing loss is a significant problem to the patient, appropriate hearing aids are fitted."
16391684|NCT00013377|Procedure|Low vision|
16391685|NCT00013364|Behavioral|Talker variability|
16391686|NCT00013351|Procedure|Prevention of Falls|
16391687|NCT00013338|Procedure|Ambulation Training|
16391688|NCT00013325|Procedure|Cardiac Disease|
16391689|NCT00013312|Procedure|Determine colonic tone|
16391690|NCT00013299|Device|Prevention of Diabetic Ulcers|
16391691|NCT00013286|Device|Prevention Diabetic Foot Ulcer|
16391692|NCT00013273|Procedure|Physical Conditioning|
16391693|NCT00013260|Procedure|Integrated model of primary care|
16391694|NCT00013247|Behavioral|Prostate Cancer Screening Education|
16391695|NCT00013234|Procedure|Teledermatology|
16391696|NCT00013221|Behavioral|Exercise|
16391697|NCT00013208|Behavioral|Case Management|
16391698|NCT00013195|Behavioral|Telephone Care|
16391699|NCT00013182|Behavioral|social activity|
16391700|NCT00013169|Behavioral|Strong Patient Focus|
16391701|NCT00013156|Procedure|Effectiveness of Lung Reduction Therapy|
16391702|NCT00013143|Behavioral|Patient risk profiling (potential ADEs) w/provider feedback|
16391703|NCT00013130|Behavioral|Provision of health status information to patients provider|
16391704|NCT00013117|Behavioral|Telephone specialist consultation|
16391705|NCT00013091|Behavioral|Self-management therapy; Psychoeducational group therapy|
16391706|NCT00013078|Procedure|Physical restoration intervention|
16391707|NCT00013052|Behavioral|Peer led classes. Led by trained veterans with a chronic disease.|
16391708|NCT00013039|Behavioral|Computer reminders|
16391709|NCT00013026|Behavioral|CHF Self-management Education (Web-based Education)|
16391710|NCT00013013|Procedure|Systems Support|
16391711|NCT00013000|Behavioral|Test strategy for implementation guideline|
16391712|NCT00012987|Behavioral|Quality Improvement|
16391713|NCT00012974|Behavioral|GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)|
16391714|NCT00012974|Procedure|Provider education, computer reminders, nurse case management|
16391715|NCT00012948|Procedure|Telephone Care|
16391716|NCT00012935|Behavioral|Help with decision making on prostate cancer treatment|
16391717|NCT00012922|Behavioral|Low Literacy Intervention for Colorectal Cancer Screening|
16391718|NCT00012909|Behavioral|Hormone Replacement Therapy Decision-Aid|
16391719|NCT00012896|Behavioral|Telephone Care + Educational (AV Materials)|
16391720|NCT00012883|Behavioral|Homewalking exercise program|
16391721|NCT00012870|Behavioral|Behavioral Management|
16391722|NCT00012857|Drug|acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN|
16391723|NCT00012844|Device|Redesigning patient handling tasks using equip: Arjo Bianca Overhead Lift, Hill-Rom Resident Transfer Device, TranSit Chair, Total Care Bed|
16391724|NCT00012844|Procedure|Redesigned patient handling tasks using work practice controls: setting bed height at correct level; applying anti-embolism stockings from foot of bed|
16391725|NCT00012818|Behavioral|relaxation technique|
16391726|NCT00012818|Behavioral|educational program|
16391727|NCT00012805|Procedure|Telephone Monitoring|
16391728|NCT00012792|Behavioral|Exercise Training|
16391729|NCT00012779|Behavioral|Health Education Program|
16391730|NCT00012766|Behavioral|Integrated team care|
16391731|NCT00012753|Procedure|Automated telephone health status assessments with nurse follow-up.|
16391732|NCT00012740|Behavioral|Casefinding and Referral System|
16391733|NCT00012727|Procedure|Matching Symptom Severity to Service Intensity|
16391734|NCT00012714|Behavioral|Case management services|
16391735|NCT00012688|Drug|Doxycycline HCI 10mg po for 2 weeks|
16391736|NCT00012688|Procedure|Ultrasonic scaling with 0.12% chlorhexidine gluconate|
16391737|NCT00012662|Behavioral|Diabetes Self Management Education|
16391738|NCT00012636|Procedure|Computer generated statements about guideline concordance of drug therapy deliver to clinicians|
16391739|NCT00012610|Procedure|Telepsychiatry|
16391740|NCT00012597|Procedure|Web-based telemedicine system for assessment of status of pressure ulcers|
16391741|NCT00012584|Drug|methylphenidate|
16391742|NCT00012584|Drug|fluvoxamine|
16391743|NCT00012558|Drug|lithium|
16391744|NCT00012558|Drug|valproate|
16391745|NCT00012558|Drug|bupropion|
16391746|NCT00012558|Drug|paroxetine|
16391747|NCT00012558|Drug|lamotrigine|
16391748|NCT00012558|Drug|risperidone|
16391749|NCT00012558|Drug|inositol|
16391750|NCT00012558|Drug|tranylcypromine|
16391751|NCT00012558|Behavioral|Cognitive Behavioral Therapy|
16391752|NCT00012558|Behavioral|Family-focused Therapy|
16391753|NCT00012558|Behavioral|Interpersonal and Social Rhythms Therapy|
16391754|NCT00012506|Drug|TNFR:Fc|
16391755|NCT00012441|Procedure|hemodialysis|
16391756|NCT00011908|Drug|hLL2 (Epratuzumab)|
16391757|NCT00011830|Drug|G-CSF|
16391758|NCT00011830|Procedure|Apheresis|
16391759|NCT00011804|Drug|Topiramate|
16391760|NCT00011778|Drug|bortezomib|
16391761|NCT00011778|Radiation|radiation therapy|
16391762|NCT00011765|Drug|Fluoxetine|
16391763|NCT00011752|Drug|FCWAY|
16391764|NCT00011713|Other|Completion questionnaires/providing biological samples|Participant completes baseline interview at enrollment, then completes online questionnaire on lifestyle and medical history. Diet questionnaire is completed at home and mailed back. Online questionnaire about personal care product use and medications is completed at each scheduled study visit.
16391765|NCT00011661|Behavioral|Education on behaviors to reduce lead exposure|
16391766|NCT00011622|Device|Continuous ambulatory subcutaneous glucose monitor|
16391767|NCT00011609|Device|Robotic Arm|
16391768|NCT00011596|Procedure|Gait Training|
16391769|NCT00011583|Device|Robot-assisted therapy|1 hour/day of mechanically-assisted upper limb therapy
16391770|NCT00011583|Device|Traditional therapy|1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
16391771|NCT00011570|Device|Bladder & Bowel Control|
16391772|NCT00011557|Device|Assistance in Voiding|
16391773|NCT00011544|Procedure|Performance Measure|
16391774|NCT00011531|Procedure|Prevention of Pressure Ulcers|
16391775|NCT00011505|Drug|G-CSF|
16391776|NCT00011505|Procedure|Leukapheresis|
16391777|NCT00011414|Drug|Tariquidar|IV alone for 1 dose (Day -1), then in combo for rest of cycle (Day 1, etc). Given in combo with one of the following: Doxorubicin (50 mg/m2 IV over 15 min on day 1), Vinorelbine (20 mg/m2 IV over 10 min on days 1 and 8), or Docetaxel (75 mg/m2 IV over 60 min on day 1).
16391778|NCT00011375|Drug|Rolipram|
16391779|NCT00011362|Drug|Dexamethasone Early|Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.
16391780|NCT00011362|Drug|Dexamethasone Late|Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was >=2.4 on treatment day 14, or an additional two weeks of saline
16391781|NCT00011297|Drug|gabapentin (Neurontin)|
16391782|NCT00011297|Drug|lorazepam (Ativan)|
16391783|NCT00011258|Drug|Paraoxonase|
16391784|NCT00011141|Drug|Oral lactobacillus administration|
16391785|NCT00011193|Behavioral|Exercise|Compared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women.
16391786|NCT00011076|Drug|Pirfenidone|
16391787|NCT00011115|Behavioral|Weight loss motivations|
16391788|NCT00011102|Behavioral|Weight Gain Prevention for Women Project|
16391789|NCT00011024|Procedure|Self Hypnosis|
16391790|NCT00011024|Procedure|Acupuncture|
16391791|NCT00011024|Procedure|Osteopathic Manipulation|
16391792|NCT00010998|Procedure|Yoga|
16391793|NCT00010985|Procedure|Acupuncture|
16391794|NCT00010985|Procedure|Chiropractic|
16391795|NCT00010985|Procedure|massage|
16391796|NCT00010972|Procedure|Acupuncture|
16391797|NCT00010959|Drug|Cimicifuga racemosa|
16391798|NCT00010959|Drug|Trifolium pratense|
16391799|NCT00010946|Procedure|Acupuncture|
16391800|NCT00010933|Drug|chamomile tea|
16391801|NCT00010933|Procedure|Relaxation/Guided Imagery|
16391802|NCT00010920|Drug|Ginkgo Biloba Extract|
16391803|NCT00010907|Drug|NPI-028|
16391804|NCT00010881|Drug|antioxidants|
16391805|NCT00010881|Behavioral|stress reduction|
16391806|NCT00010868|Drug|Omega-3 Fatty Acids|
16391807|NCT00010855|Behavioral|Self-hypnotic relaxation|
16391808|NCT00010842|Drug|Ginkgo biloba|
16391809|NCT00010842|Drug|Alpha-lipoic acid|
16391810|NCT00010842|Drug|Vitamin E/Selenium|
16391811|NCT00010842|Drug|Essential fatty acids|
16391812|NCT00010829|Behavioral|American Heart Association Step 1 diet|
16391813|NCT00010829|Behavioral|American Heart Association Step 2 diet + 10 g/day flax seed|
16391814|NCT00010829|Behavioral|Macrobiotic dietary intervention|
16391815|NCT00010816|Drug|Herbal remedies|
16391816|NCT00010803|Drug|Ginkgo biloba|120mg twice a day
16391817|NCT00010803|Drug|Placebo|One pill twice daily
16391818|NCT00010777|Procedure|Multiple Component Mind/Body therapy|
16391819|NCT00010764|Procedure|Acupuncture|
16391820|NCT00010751|Procedure|Reiki|
16391821|NCT00010738|Procedure|Meditation|
16391822|NCT00010725|Drug|MAK|
16391823|NCT00010725|Drug|Vitamin Supplements|
16391824|NCT00010712|Drug|Black Cohosh|
16391825|NCT00010699|Drug|Vitamin E|
16391826|NCT00010686|Drug|Dietary Phytoestrogens|
16391827|NCT00010634|Drug|Connective Tissue Nutrient Formula|
16391828|NCT00010634|Drug|Adaptogenic herbs|
16391829|NCT00010634|Drug|glutamine|
16391830|NCT00010621|Procedure|Acupuncture|
16391831|NCT00010621|Procedure|chiropractic therapy|
16391832|NCT00010621|Procedure|bodywork therapy|
16391833|NCT00010608|Behavioral|Transcendental Meditation|a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.
16391834|NCT00010608|Behavioral|Health Education|didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake
16391835|NCT00010530|Procedure|Meditation|
16391836|NCT00010517|Procedure|Acupuncture|
16391837|NCT00010504|Procedure|Acupuncture|
16391838|NCT00010491|Procedure|Acupuncture|
16391839|NCT00010491|Procedure|Moxibustion|
16391840|NCT00010478|Procedure|Acupuncture|
16391841|NCT00010465|Procedure|Craniosacral Osteopathic Manipulative Treatment|
16391842|NCT00010465|Drug|Botanicals|
16391843|NCT00009685|Drug|VRC4302|
16391844|NCT00009672|Drug|Nortriptyline|
16391845|NCT00009672|Drug|Morphine|
16391846|NCT00009659|Drug|CDB 2914|
16391847|NCT00009646|Drug|indomethacin|Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa
16391848|NCT00009646|Drug|Indomethacin|0.1 mg per kilogram of body weight
16391849|NCT00009646|Drug|Placebo|0.1 mg per kilogram of body weight
16391850|NCT00009620|Drug|Phenobarbital|10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)
16391851|NCT00009620|Drug|Saline|Infusion of normal sal
16391852|NCT00010452|Drug|picibanil|Up to .2 mg per injection, given intralesionally every 6-8 weeks
16391853|NCT00010439|Drug|Alendronate|Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
16391854|NCT00010426|Drug|cysteamine hydrochloride|
16391855|NCT00010413|Drug|cyclophosphamide|
16391856|NCT00010413|Drug|filgrastim|
16391857|NCT00010400|Drug|Cyclophosphamide|
16391858|NCT00010400|Drug|filgrastim|
16391859|NCT00010387|Drug|cyclophosphamide|
16391860|NCT00010387|Drug|filgrastim|
16391940|NCT00007033|Drug|magnesium gluconate|
16391861|NCT00010374|Device|NeuRx DPS|Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.
16391862|NCT00010361|Drug|cyclosporine|
16391863|NCT00010361|Drug|fludarabine|
16391864|NCT00010361|Drug|mycophenolate mofetil|
16391865|NCT00010335|Procedure|Stem Cell Transplantation|Participants will receive a stem cell transplantation along with irradiation and the drugs anti-thymocyte globulin, cyclophosphamide, and filgrastim as noted in the text of this record.
16391866|NCT00010335|Device|CD34 selection|CD34+ cells are separated from the rest of the peripheral blood stem cells.
16391867|NCT00009594|Procedure|Naturopathic Medicine|
16391868|NCT00009594|Procedure|Traditional Chinese Medicine|
16391869|NCT00009581|Drug|L-NMMA|
16391870|NCT00009581|Drug|Acetylcholine|
16391871|NCT00009230|Drug|Celecoxib|
16391872|NCT00009217|Drug|Haloperidol-Haloperidol|Haloperidol open label flexible dose 1-5 mg daily for 20 weeks followed by haloperidol double-blind 1-5 mg for 24 weeks
16391873|NCT00009217|Drug|Haloperidol-Placebo|Haloperidol open-label flexible dose of 1-5 mg for 20 weeks followed by placebo double-blind for 24 weeks
16391874|NCT00009204|Drug|Citalopram [Celexa]|
16391875|NCT00009204|Drug|Perphenazine [Trilafon]|
16391876|NCT00009191|Drug|Sertraline [Zoloft]|
16391877|NCT00009048|Drug|EMD 128130|
16391878|NCT00009048|Drug|IV Levodopa|
16391879|NCT00009178|Drug|Fluoxetine|
16391880|NCT00009178|Behavioral|Guided Self-Help|
16391881|NCT00009009|Drug|immunosuppressive regimen designed to complement HAART|
16391882|NCT00008801|Drug|hOKT3gamma1 (Ala-ala)|
16391883|NCT00008775|Device|Pressure support ventilation|
16391884|NCT00008736|Drug|metoclopramide|
16391885|NCT00008827|Behavioral|Behavioral weight loss|
16391886|NCT00008515|Drug|Fluocinolone|
16391887|NCT00008476|Drug|Capsaicin|
16391888|NCT00008450|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
16391889|NCT00008450|Drug|Cyclosporine|Given PO or IV
16391890|NCT00008450|Other|Laboratory Biomarker Analysis|Correlative studies
16391891|NCT00008450|Drug|Mycophenolate Mofetil|Given PO or IV
16391892|NCT00008450|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative allogeneic hematopoietic stem cell transplant
16391893|NCT00008450|Radiation|Total-Body Irradiation|Undergo TBI
16391894|NCT00007800|Behavioral|Behavioral Group Weight Loss Intervention|
16391895|NCT00007800|Behavioral|Motivational Interviewing|
16391896|NCT00007670|Drug|Carbamazepine|
16391897|NCT00007670|Drug|Gabapentin|
16391898|NCT00007670|Drug|Lamotrigine|
16391899|NCT00007657|Procedure|Intensive medical therapy|
16391900|NCT00007657|Procedure|Percutaneous Coronary Intervention (PCI) plus intensive medical therapy|
16391901|NCT00007774|Drug|Haloperidol|
16391902|NCT00007774|Drug|Olanzapine|
16391903|NCT00007761|Behavioral|Bipolar Disorder Program|
16391904|NCT00007761|Behavioral|Usual (psychiatric) Care|
16391905|NCT00007748|Behavioral|Aerobic exercise|
16391906|NCT00007748|Behavioral|Cognitive behavioral therapy|
16391907|NCT00007735|Drug|Doxycycline (200mg/day) or Placebo|
16391908|NCT00007683|Drug|Warfarin titrated to an INR of 2.5-3.0|anticoagulation (administered without blinding) titrated to a target INR of 2.5 to 3.0, monitored by measurements at 6 week intervals after initial titration and stabilization.
16391909|NCT00007683|Drug|Aspirin|an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
16391910|NCT00007683|Drug|Clopidogrel 75|(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
16391911|NCT00007644|Procedure|Radical prostatectomy|Surgical removal of the prostate
16391912|NCT00007631|Drug|Tretinoin 0.1% cream or placebo|
16391913|NCT00007631|Other|Placebo|Patients receive placebo for same amount of time
16391914|NCT00007605|Drug|Amiodarone|Patients assigned will receive 400 mg bid for 14 days, 400 mg QAM and 200 mg QHS for 14 days, 300 mg qd for 48 weeks, then 200 mg qd.
16391915|NCT00007605|Drug|Sotalol|Patients assigned will receive 80 mg bid for 7 days and 160 mg bid thereafter.
16391916|NCT00007592|Drug|Chlorthalidone|
16391917|NCT00007592|Drug|Furosemide|
16391918|NCT00007527|Drug|naloxone|
16391919|NCT00007527|Drug|buprenorphine|
16391920|NCT00007501|Biological|Varicella-zoster vaccine|Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
16391921|NCT00007501|Biological|Placebo|Placebo vaccine
16391922|NCT00007475|Procedure|Plasma exchange|A course of plasma exchange of 5 treatments over 10 days, then administration of cyclophosphamide.
16391923|NCT00007475|Drug|Cyclophosphamide|For GFR > 50 ml/min/1.73 m2 received oral cyclophosphamide at a dose of 2 mg/kg/ day for 3 months. For GFR < 50 ml/min/1.73 m2 but > 10 ml/min/1.73 m2 will receive oral cyclophosphamide at a 25% reduced dose or 1.5 mg/kg/d for 3 months.
16391924|NCT00007358|Drug|Dexamethasone or other corticosteroid|Administered during the third trimester of pregnancy
16391925|NCT00007345|Drug|Romidepsin|
16391926|NCT00007306|Drug|Parathyroid hormone ointment|
16391927|NCT00007293|Device|UV-B Lightsource and Fiber Optic Comb|
16391928|NCT00007280|Device|Bioengineered skin|
16391929|NCT00007267|Behavioral|Cognitive behavioral therapy|
16391930|NCT00007267|Behavioral|Disease/health education|
16391931|NCT00007267|Behavioral|Self-help cognitive behavioral intervention facilitated by a psychologist|
16391932|NCT00007254|Drug|Pain relief for pressure ulcers|
16391933|NCT00007241|Device|Isometric exercise|
16391934|NCT00007189|Drug|Naproxen Sodium (Aleve)|
16391935|NCT00007189|Drug|Celecoxib (Celebrex)|
16391936|NCT00007163|Drug|J695|
16391938|NCT00007085|Device|Tomography, X-ray Computed|
16391939|NCT00007059|Drug|mycophenolate mofetil|
16391941|NCT00007033|Drug|magnesium sulfate|
16391942|NCT00007020|Drug|Cholic Acids|10-15 mg/kg body weight/day taken orally.
16391943|NCT00006565|Device|HEPA Air Cleaner|Placement of two active HEPA air cleaners in the homes of children
16391944|NCT00006565|Device|Placebo Filtration Unit|Placement of inactive filtration unit in the homes
16391945|NCT00006519|Drug|Capravirine|
16391946|NCT00006517|Device|bright light box|10,000 lux bright light therapy
16391947|NCT00006517|Device|dawn simulator|gradual rise in bedroom illumination prior to wake-up
16391948|NCT00006517|Device|high-output negative ion generator|automated air ion delivery in bedroom prior to wake-up
16391949|NCT00006517|Device|low-output negative ion generator|automated air ion delivery in bedroom prior to wake-up
16391950|NCT00006517|Device|dawn light pulse|rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
16391951|NCT00006516|Behavioral|Infant stimulation|
16391952|NCT00006508|Procedure|Controlled hypoglycemia using insulin|
16391953|NCT00006508|Procedure|formula meal|
16391954|NCT00006505|Drug|Islet Transplantation|Islet cell transplantation. This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy
16391955|NCT00006501|Procedure|ECG|A diagnostic tool that is routinely used to assess the electrical and muscular functions of the heart (non-experimental).
16391956|NCT00006493|Drug|Rosiglitazone|
16391957|NCT00006489|Behavioral|Cognitive-Behavioral Therapy|Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
16391958|NCT00006489|Drug|Naltrexone|Daily dosing 100 mg for 24 weeks
16391959|NCT00006489|Drug|Placebo|Pill Placebo daily dosing 24 weeks
16391960|NCT00006488|Drug|recombinant-methionyl human glial cell line-derived neurotrophic factor|
16391961|NCT00006450|Drug|Phenylbutyrate|
16391962|NCT00006449|Drug|naltrexone (Revia)|
16391963|NCT00006449|Behavioral|broad spectrum treatment|
16391964|NCT00006449|Behavioral|motivational enhancement therapy|
16391965|NCT00006507|Behavioral|Occupational Therapy|
16391966|NCT00006448|Behavioral|cognitive therapy|
16391967|NCT00006448|Procedure|Physical Therapy|
16391968|NCT00006448|Drug|Methadone|
16391969|NCT00006447|Procedure|Social Support|
16391970|NCT00006446|Procedure|Training in parenting skills and communication|
16391971|NCT00006445|Procedure|Ultrasound|
16391972|NCT00006445|Procedure|Serum screen|
16391973|NCT00006439|Behavioral|Counseling in the home|
16391974|NCT00006438|Device|Shoes with Rocker Soles|
16391975|NCT00006436|Biological|Rituximab|2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
16391976|NCT00006436|Biological|filgrastim|Figrastim day 6 until ANC reaches 5000 after the nadir, every cycle
16391977|NCT00006436|Drug|EPOCH|combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
16391978|NCT00006434|Biological|tumor-pulsed dendritic cells|
16391979|NCT00006433|Drug|Doxil|
16391980|NCT00006433|Procedure|heat treatment|
16391981|NCT00006432|Procedure|very low fat diet|
16391982|NCT00006431|Biological|DC RCC-RNA|
16391983|NCT00006430|Biological|Autologous dendritic cells transfected with amplified tumor RNA|
16391984|NCT00006429|Procedure|body weight-supported treadmill training|
16391985|NCT00006428|Drug|Amitriptyline|
16391986|NCT00006427|Drug|Amitriptyline|
16391987|NCT00006426|Procedure|Achilles tendon-lengthening surgery|
16391988|NCT00006422|Procedure|current standard of care treatments|
16391989|NCT00006418|Procedure|DNA collection|
16391990|NCT00006417|Procedure|Stem cell transplantation|
16391991|NCT00006413|Procedure|Stem cell transplantation|
16391992|NCT00006411|Other|corneas assigned by donor age group|A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors >=66 and <66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
16391993|NCT00006409|Behavioral|Trial of Activity for Adolescent Girls (TAAG)|Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program.
16391994|NCT00006405|Behavioral|Exercise|
16391995|NCT00006401|Drug|iNO|Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
16391996|NCT00006401|Other|Placebo|Inhaled Nitrogen
16391997|NCT00006400|Drug|Hydroxyurea|Participants will receive hydroxyurea.
16391998|NCT00006400|Drug|Placebo|Participants will receive placebo.
16391999|NCT00006398|Drug|Timolol Maleate|
16392000|NCT00006398|Drug|Placebo|
16392001|NCT00006394|Drug|growth hormone|
16392002|NCT00006337|Drug|KW-6002|
16392003|NCT00006337|Drug|IV Levodopa|
16392004|NCT00006332|Drug|Tetrathiomolybdate|
16392005|NCT00006331|Procedure|renal transplant|
16392006|NCT00006330|Drug|Digoxin|
16392007|NCT00006330|Drug|Hawthorn|
16392008|NCT00006329|Procedure|Minimally invasive radioguided parathyroidectomy|
16392009|NCT00006320|Procedure|determine blood levels of anti-HIV drugs|
16392010|NCT00006305|Procedure|Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions|Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
16392011|NCT00006305|Procedure|Coronary Artery Bypass|Coronary Artery Bypass
16392012|NCT00006305|Drug|Biguanides, thiazolidinediones|Biguanides, thiazolidinediones
16392013|NCT00006305|Drug|Insulin, sulfonylurea|Insulin, sulfonylurea
16392014|NCT00006305|Drug|ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers|ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
16392015|NCT00006299|Drug|Celebrex|
16392016|NCT00006294|Drug|Chlorthalidone|participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study
16392017|NCT00006294|Drug|Lisinopril|participant's drug dose will be titrated from 10mg to 40mg over the course of the study
16392018|NCT00006294|Drug|Amlodipine|participant's drug dose will be titrated from 10mg to 40mg over the course of the study
16392019|NCT00006294|Drug|Doxazosin|participant's drug dose will be titrated from 2mg to 8mg over the course of the study
16392020|NCT00006292|Drug|Infliximab|
16392021|NCT00006289|Drug|Placebo|4 tabs b.i.d.
16392022|NCT00006289|Drug|Neurotropin|4 tabs b.i.d.
16392023|NCT00006286|Drug|Fluoxetine|
16392024|NCT00006286|Behavioral|Psychotherapy|
16392025|NCT00006276|Drug|Micellar Paclitaxel|
16392026|NCT00006280|Drug|Tobramycin for Inhalation|
16392027|NCT00006275|Drug|calcitriol|
16392028|NCT00006270|Drug|cosyntropin|
16392029|NCT00006270|Drug|metyrapone|
16392030|NCT00006206|Drug|naltrexone (Revia)|
16392031|NCT00006206|Drug|acamprosate (Campral)|
16392032|NCT00006205|Drug|ondansetron + cognitive behavioral therapy|ondansetron (4 mcg/kg b.i.d)
16392033|NCT00006205|Drug|topiramate + cognitive behavioral therapy|topiramate (up to 300 mg/day)
16392034|NCT00006205|Drug|Placebo + cognitive behavioral therapy|placebo
16392035|NCT00006205|Drug|ondansetron + topiramate + cognitive behavioral therapy|ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
16392036|NCT00006204|Drug|naltrexone (Revia)|
16392037|NCT00006204|Drug|fluoxetine (Prozac)|
16392038|NCT00006203|Drug|naltrexone (Revia)|
16392039|NCT00006202|Drug|Lutein|
16392040|NCT00006200|Drug|thalidomide|
16392041|NCT00006200|Drug|dacarbazine|
16392042|NCT00006199|Drug|R115777 (farnesyl transferase inhibitor)|
16392043|NCT00006199|Drug|Topotecan|
16392044|NCT00006198|Drug|thalidomide|
16392045|NCT00006198|Procedure|chemoembolization with doxorubicin/collagen|
16392046|NCT00006196|Drug|Vitamin D|
16392047|NCT00006195|Drug|risperidone|
16392048|NCT00006195|Drug|olanzapine|
16392049|NCT00006194|Behavioral|Exercise|
16392050|NCT00006193|Behavioral|diet|
16392051|NCT00006190|Drug|Nelfinavir mesylate|
16392052|NCT00006190|Drug|Stavudine|
16392053|NCT00006190|Drug|Lamivudine|
16392054|NCT00006190|Drug|Efavirenz|
16392055|NCT00006187|Drug|Investigational drug|
16392056|NCT00006186|Procedure|Autologous fresh whole blood|
16392057|NCT00006184|Drug|Myeloma Immunoglobulin Idiotype Vaccine|3 subcutaneous (SC) injections of myeloma protein within 10 weeks before stem cell collection the first (week 0), second (week 2), and third injection (week 6) with Id-KLH (0.5 mg SC day 1)
16392058|NCT00006184|Drug|Bortezomib|Induction chemotherapy: 1.3 mg/m^2 bolus intravenous injection twice weekly for 2 weeks (days 1, 4, 8, 11) followed by 10 day rest period (day 12-21)
16392059|NCT00006184|Drug|Cyclophosphamide|Induction chemotherapy: 600 mg/m^2 day 4 Transplant: 1200 mg/m^2 intravenous x 4 days (days -6, -5, -4, -3)
16392060|NCT00006184|Drug|Cyclosporine|Transplant: 2 mg/kg intravenous every 12 hours continuous intravenous or by mouth (PO) until day + 180
16392061|NCT00006184|Drug|Doxorubicin hydrochloride|Induction chemotherapy: 10 mg/m^2 day continuous intravenous (CIV) days 1-3
16392062|NCT00006184|Drug|Etoposide|Induction chemotherapy: 50 mg/m^2 day continuous intravenous days 1-3
16392063|NCT00006184|Drug|Fludarabine phosphate|Induction chemotherapy: 25 mg/m^2 day intravenous days 1-3 Transplant: 30 mg/m^2 day x 4 days (days -6, -5, -4, -3 )
16392064|NCT00006184|Drug|Prednisone|60 mg/m^2 day 1-4
16392065|NCT00006184|Drug|Vincristine Sulfate|Induction chemotherapy: 0.5 mg/m^2 day continuous intravenous days 1-3
16392066|NCT00006184|Drug|Methotrexate|Transplant: 5 mg/m^2 intravenous on days +1, +3, +6, +11
16392067|NCT00006184|Biological|GMCSF (granulocyte macrophage colony stimulating factor)|250 mcg/m^2 subcutaneously every day, days 1-4
16392068|NCT00006184|Biological|GCSF (granulocyte colony stimulating factor)|10 mcg/kg per day subcutaneously daily from day 5 until absolute neutrophil count (ANC) > 1000/ul x 2 days
16392069|NCT00006185|Drug|Avandia administration for 6-12 weeks|
16392070|NCT00006183|Procedure|Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits|
16392071|NCT00006183|Procedure|Thoracic Surgery|
16392072|NCT00006182|Procedure|Blood Transfusion|
16392073|NCT00006399|Drug|Donepezil|
16392074|NCT00006399|Drug|Estrogen|
16392075|NCT00006399|Drug|Progesterone|
16392076|NCT00006181|Behavioral|Team-based intervention|
16392077|NCT00006181|Behavioral|One-on-one intervention|
16392078|NCT00006180|Drug|Alendronate|
16392079|NCT00006178|Drug|Sirolimus|
16392080|NCT00006178|Drug|Thymoglobulin|
16392081|NCT00006174|Drug|Letrozole|
16392082|NCT00006172|Device|Bright light box|60-min light therapy shortly after awakening
16392083|NCT00006172|Device|High-output negative ion generator|60-min high-density ion exposure shortly after awakening
16392084|NCT00006172|Device|Low-output negative ion generator|60-min low-density ion exposure shortly after awakening
16392085|NCT00006170|Drug|Bupropion|smoking cessation medication aid
16392086|NCT00006170|Drug|Placebo|A matched placebo pill
16392087|NCT00006170|Behavioral|weight concerns intervention|cognitive behavioral treatment to address weight concners
16392088|NCT00006170|Behavioral|smoking cessation intervention|Cognitive behavioral intervention for smoking cessation
16392089|NCT00006156|Other|Control|No injection of FSH
16392090|NCT00006156|Drug|Drug: FSH|FSH Stimulation Test
16392091|NCT00006169|Behavioral|Behavioral Treatment|
16392092|NCT00006168|Drug|Methotrexate|
16392093|NCT00006167|Drug|oxandrolone|
16392094|NCT00006167|Behavioral|Progressive Resistance Training|
16392095|NCT00006166|Procedure|Transjugular intrahepatic portasystemic shunts (TIPS)|
16392096|NCT00006166|Procedure|Total paracentecis (TP)|
16392097|NCT00006165|Behavioral|'Ohana (Family) Support Lifestyle Intervention|
16392098|NCT00006164|Drug|Peginterferon alfa-2a + Ribavirin|Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight <75 kg, >75 kg) daily in two divided doses for 24 weeks
16392099|NCT00006164|Drug|Peginterferon alfa-2a|90 mcg/week injection, for 3.5 years
16392100|NCT00006163|Behavioral|Personalized Self-management|
16392101|NCT00006163|Behavioral|Community Resources|
16392102|NCT00006162|Behavioral|exercise and diet|
16392103|NCT00006161|Procedure|Transjugular Intrahepatic Portosystemic Shunt (TIPS)|
16392104|NCT00006161|Procedure|Distal Splenorenal Shunt|
16392105|NCT00006160|Behavioral|home based worker|
16392106|NCT00006159|Behavioral|lifestyle (exercise, diet, and family and community support)|
16392107|NCT00006158|Drug|Testosterone|
16392108|NCT00006157|Drug|Desipramine|
16392109|NCT00006157|Behavioral|Cognitive Behavioral Treatment|
16392110|NCT00006151|Behavioral|Behavioral Therapy|Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
16392111|NCT00006077|Drug|NS2330|
16392112|NCT00006077|Drug|Levodopa and Domperidone|
16392113|NCT00006142|Behavioral|phenylalanine restricted diet|
16392114|NCT00006137|Drug|enalapril|
16392115|NCT00006136|Drug|arginine butyrate|
16392116|NCT00006136|Drug|epoetin alfa|
16392117|NCT00006135|Drug|acyclovir|
16392118|NCT00006133|Drug|estradiol|
16392119|NCT00006133|Drug|ethinyl estradiol|
16392120|NCT00006133|Drug|medroxyprogesterone|
16392121|NCT00006133|Drug|norethindrone|
16392122|NCT00006132|Drug|acyclovir|
16392123|NCT00006131|Drug|Valacyclovir|
16392124|NCT00006130|Procedure|Core decompression|
16392125|NCT00006129|Drug|testosterone|
16392126|NCT00006127|Drug|amifostine|
16392127|NCT00006072|Drug|Rituxan|
16392128|NCT00006070|Drug|etanercept (Enbrel)|
16392129|NCT00006068|Procedure|Pancreatic Islet Transplantation|
16392130|NCT00005937|Drug|Antithymocyte globulin|Antithymocyte globulin (ATG) intravenous infusion: 40mg/kg/day. Infusion over 6 hours on day 1-4.
16392131|NCT00005937|Drug|Cyclosporine|Cyclosporine (CsA) intravenous infusion: 5mg/kg. Infusion on day 14 administered twice a day.
16392132|NCT00005935|Drug|Mycophenolate mofetil|
16392133|NCT00005935|Drug|Cyclosporine|
16392134|NCT00005934|Drug|5-Azacytidine|
16392135|NCT00006063|Drug|pancrelipase with bicarbonate|
16392136|NCT00006061|Drug|phosphatidylcholine|
16392137|NCT00006060|Drug|standard gadolinium contrast|
16392138|NCT00006056|Drug|anti-thymocyte globulin|
16392139|NCT00006056|Drug|busulfan|
16392140|NCT00006056|Drug|cyclophosphamide|
16392141|NCT00006056|Drug|cyclosporine|
16392142|NCT00006056|Drug|etoposide|
16392143|NCT00006056|Drug|filgrastim|
16392144|NCT00006056|Drug|methotrexate|
16392145|NCT00006056|Procedure|allogeneic hematopoietic stem cell transplantation|
16392146|NCT00006055|Drug|anti-thymocyte globulin|
16392147|NCT00006055|Drug|cyclophosphamide|
16392148|NCT00006055|Drug|cyclosporine|
16392149|NCT00006055|Drug|filgrastim|
16392150|NCT00006055|Drug|methylprednisolone|
16392151|NCT00006055|Drug|prednisone|
16392152|NCT00006055|Procedure|Autologous Peripheral Blood Stem Cell Transplantation|
16392153|NCT00006054|Drug|anti-thymocyte globulin|
16392154|NCT00006054|Drug|busulfan|
16392155|NCT00006054|Drug|cyclophosphamide|
16392156|NCT00006054|Drug|cyclosporine|
16392157|NCT00006054|Drug|etoposide|
16392158|NCT00006054|Drug|methotrexate|
16392159|NCT00006054|Drug|methylprednisolone|
16392160|NCT00006054|Drug|prednisone|
16392161|NCT00006054|Procedure|Allogeneic Bone Marrow Transplantation|
16392162|NCT00005928|Drug|Ramipril|
16392163|NCT00005925|Drug|Muscimol|
16392164|NCT00005922|Behavioral|Partial schedule of pharmacotherapeutic reinforcement|Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
16392165|NCT00005922|Drug|Dose control for Arm B|Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
16392166|NCT00005922|Other|Standard pharmacotherapeutic protocol|Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
16392167|NCT00005916|Drug|rV-PSA|
16392168|NCT00005916|Drug|rF-PSA|
16392169|NCT00005916|Drug|rV-B7.1|
16392170|NCT00005910|Procedure|Intraoperative ultrasound|
16392171|NCT00005908|Drug|Docetaxel - Dose A|Dose A-Cohort 1 Docetaxel 75 mg/m^2 intravenous day 1
16392172|NCT00005908|Drug|Anastrozole|1 mg orally daily for five years
16392173|NCT00005908|Drug|cyclophosphamide|600 mg/m^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1
16392174|NCT00005908|Drug|Docetaxel - Dose B|Dose B - Cohort 2 Docetaxel 60 mg/m^2 intravenous day 1
16392175|NCT00005908|Drug|Doxorubicin hydrochloride|60 mg/m^2 will be administered as a slow intravenous push on day 1
16392176|NCT00005908|Drug|Tamoxifen Citrate|20 mg/day orally for five years
16392177|NCT00005908|Drug|Capecitabine - Dose B|Dose B - Cohort 2 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
16392178|NCT00005908|Drug|Capecitabine - Dose A|capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
16392179|NCT00005906|Drug|Octreotide|Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day.
16392180|NCT00005905|Drug|hu Leptin (A-100)|
16392181|NCT00005903|Drug|GDNF & Synchro Med Infusion System|
16392182|NCT00005901|Drug|Pamidronate (Aredia)|Patients receive a dose of 1mg/kg/cycle (3-day infusion = 1 cycle)
16392183|NCT00005898|Drug|anti-thymocyte globulin|
16392184|NCT00005898|Drug|cyclophosphamide|
16392185|NCT00005898|Drug|cyclosporine|
16392186|NCT00005898|Drug|filgrastim|
16392187|NCT00005898|Drug|fludarabine|
16392188|NCT00005898|Drug|methylprednisolone|
16392189|NCT00005896|Drug|filgrastim|
16392190|NCT00005896|Genetic|Autologous stem cells transduced with FACC retroviral vector|
16392191|NCT00005896|Procedure|Autologous Stem Cell Transplantation|
16392192|NCT00005893|Drug|anti-thymocyte globulin|
16392193|NCT00005893|Drug|busulfan|
16392194|NCT00005893|Drug|cyclophosphamide|
16392195|NCT00005893|Procedure|Bone marrow transplantation|
16392196|NCT00005892|Drug|cyclophosphamide|
16392197|NCT00005892|Procedure|Allogeneic Bone Marrow Transplantation|
16392198|NCT00005891|Drug|cyclophosphamide|
16392199|NCT00005891|Procedure|Allogeneic Bone Marrow Transplantation|
16392200|NCT00005890|Drug|corticotropin|
16392201|NCT00005889|Drug|alanine|
16392202|NCT00005889|Drug|amino acids|
16392203|NCT00005889|Drug|glucagon|
16392204|NCT00005889|Drug|glucose|
16392205|NCT00005889|Drug|glutamine|
16392206|NCT00005889|Drug|glycerol|
16392207|NCT00005889|Drug|insulin|
16392208|NCT00005889|Drug|leucine|
16392209|NCT00005889|Drug|lipids|
16392210|NCT00005889|Drug|urea|
16392211|NCT00005888|Behavioral|Fortified Pasteurized Donor Human Milk supplement|
16392212|NCT00005888|Behavioral|Preterm Formula supplement|
16392213|NCT00005785|Drug|GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV|
16392214|NCT00005782|Drug|Granulocyte colony-stimulating factor|
16392215|NCT00005782|Procedure|Leukapheresis|
16392216|NCT00005780|Drug|EPOCH-R|EPOCH-R for 6 cycles
16392217|NCT00005780|Biological|GM-CSF|GM-CSF monthly with the vaccine for 5 doses
16392218|NCT00005780|Biological|Idiotype vaccine|1 injection of vaccine monthly for 5 doses
16392219|NCT00005778|Drug|High-dose immunoablative therapy|"High dose cyclophosphamide for 4 days.
~NIH monthly IV cytoxan for 6 months followed by quarterly for 2 years."
16392220|NCT00005777|Procedure|Minimal mechanical ventilation management|Partial pressure of carbon dioxide (PCO2) target (>52 mm Hg)
16392221|NCT00005777|Procedure|Routine mechanical ventilation management|Partial pressure of carbon dioxide (PCO2) target <48 mm Hg)
16392222|NCT00005777|Drug|Dexamethasone|Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
16392223|NCT00005777|Drug|Placebo|The infants in the placebo groups received equal volumes of saline.
16392224|NCT00005776|Drug|Inhaled nitric oxide|Inhaled Nitric oxide at a concentration of 20 ppm
16392225|NCT00005776|Drug|Placebo|100% Oxygen
16392226|NCT00005775|Drug|Glutamine|Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
16392227|NCT00005775|Drug|Placebo|TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
16392228|NCT00005774|Drug|Early surfactant|Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
16392229|NCT00005774|Drug|Standard practice|Surfactant according to current center practice, only after initiation of mechanical ventilation.
16392230|NCT00005773|Drug|Inhaled Nitric Oxide|Study gas was initiated at a concentration of 5 ppm, and the dose was increased to 20 ppm when the infant had <=20 mm Hg increase in PaO2 (less than full response).
16392231|NCT00005773|Drug|Standard iNO therapy|Begin a sham initiation of iNO in term and near-term infants in respiratory failure with an oxygenation index (OI) between 15-25; initiated actual iNO therapy based on standard threshold (OI >=25).
16392232|NCT00005772|Device|Induced hypothermia|Whole-body cooling using the Blanketrol II or III Units in the Automatic Control Mode with a YSI 400 series temperature probe placed in the distal esophagus over a 96-hour period
16392233|NCT00005772|Device|Control|Control group: standard care
16392234|NCT00005771|Device|Visual utrasound feedback|
16392235|NCT00005771|Procedure|Abdominal Hollowing Exercise|
16392236|NCT00005770|Device|Acupuncture|
16392237|NCT00005769|Drug|Hormone Replacement Therapy|
16392238|NCT00005768|Drug|Estrogen|
16392239|NCT00005766|Drug|Creatinine|
16392240|NCT00005765|Drug|nicotine|
16392241|NCT00005765|Drug|alcohol|
16392242|NCT00005675|Drug|Oral bovine type I collagen|500 mcg of CI daily for 15 months
16392243|NCT00005675|Drug|Placebo|CI placebo daily for 15 months
16392244|NCT00005674|Drug|Creatine|
16392245|NCT00005743|Behavioral|exercise|
16392246|NCT00005743|Behavioral|weight loss|
16392247|NCT00005739|Behavioral|Community-based directly observed therapy (DOT)|A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
16392248|NCT00005739|Behavioral|Clinic directly observed therapy (DOT)|A traditional self-administered preventive treatment
16392249|NCT00005727|Behavioral|Intervention|Classroom-based nutrition education curriculum designed for individuals with low literacy skills.
16392250|NCT00005724|Behavioral|Computer Program Intervention Group|A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.
16392251|NCT00005724|Other|Minimal Intervention Group|Dietary Information pamphlets.
16392408|NCT00004767|Behavioral|Dietary Intervention|
16392409|NCT00004763|Drug|leuprolide|
16392410|NCT00004763|Drug|Ethinyl estradiol/norethindrone|
16392252|NCT00005724|Behavioral|Health Counselor Intervention Group|Food for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits.
16392253|NCT00005713|Behavioral|Continuing, preventative care|Training for intervention clinic staff was based on National Asthma Education and Prevention Program guidelines for the diagnosis and management of asthma, and included screening to identify new cases and health education to improve family management.
16392254|NCT00005711|Behavioral|Asthma self-management education|"Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma (triggers), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish."
16392255|NCT00005684|Drug|warfarin|
16392256|NCT00005684|Drug|heparin|
16392257|NCT00005555|Behavioral|Exercise|
16392258|NCT00005553|Procedure|Catheter Ablation|
16392259|NCT00005520|Drug|Hydrochlorothiazide|
16392260|NCT00005520|Drug|Candesartan|
16392261|NCT00005399|Other|No interventions|No interventions
16392262|NCT00005398|Other|There is no intervention|No applicable
16392263|NCT00005305|Other|No interventions - observational study|
16392264|NCT00005195|Procedure|Catheter ablation|
16392265|NCT00005137|Other|exercise program|subjects were measured before and after a 20-week long on-site exercise training program
16392266|NCT00005673|Drug|Capravirine|
16392267|NCT00005669|Drug|Metformin HCL|Medication studied for ability to alter body weight and body composition.
16392268|NCT00005669|Drug|Placebo|Control capsules for metformin
16392269|NCT00005666|Procedure|PET scan use in radiotherapy planning|
16392270|NCT00005665|Drug|interferon alpha|
16392271|NCT00005658|Drug|Glycine|
16392272|NCT00005655|Biological|rh IL-12|rhIL-12 will be administered intravenously on days 2, 4, 6, 10, 12 and 14 of each cycle.
16392273|NCT00005655|Biological|rh IL-2|rhIL-2 will be administered intravenously every 8 hours x 3 doses on days 1 and 9 of each cycle.
16392274|NCT00005654|Drug|clomiphene citrate|
16392275|NCT00005654|Drug|metformin|
16392276|NCT00005652|Drug|rituximab|
16392277|NCT00005575|Drug|Imipramine|
16392278|NCT00005575|Behavioral|Cognitive-behavior therapy|
16392279|NCT00005571|Drug|h5G1.1-mAb|
16392280|NCT00005569|Drug|SLPI (Secretory Leukocyte Protease Inhibitor)|
16392281|NCT00005567|Behavioral|Parental knowledge and beliefs about infant sleep position|
16392282|NCT00005566|Behavioral|Desperation Scale|
16392283|NCT00005119|Procedure|Measures of calcium and bone turnover|
16392284|NCT00005117|Drug|pravastatin|
16392285|NCT00005112|Drug|Human recombinant growth hormone|
16392286|NCT00005116|Behavioral|psychotherapy|
16392287|NCT00005110|Drug|Salmeterol|
16392288|NCT00005110|Drug|Albuterol|
16392289|NCT00005108|Drug|Estradiol|
16392290|NCT00005108|Drug|Progesterone|
16392291|NCT00005107|Drug|N-monomethyl-L-arginine|
16392292|NCT00005104|Drug|clomiphene citrate|
16392293|NCT00005104|Drug|metformin|
16392294|NCT00005015|Drug|Fluoxetine|
16392295|NCT00005014|Drug|Risperidone|
16392296|NCT00005013|Drug|Sertraline|
16392297|NCT00005013|Drug|Hypericum perforatum (St. John's wort)|
16392298|NCT00005007|Drug|Etanercept|
16392299|NCT00005006|Drug|Parathyroid Hormone|Alendronate 70mg/week; Teriparatide 20mcg/ day
16392300|NCT00005006|Drug|Alendronate|Alendronate 70mg/week
16392301|NCT00005006|Drug|Teriparatide|Teriparatide 20mcg/day
16392302|NCT00005005|Drug|PTH|
16392303|NCT00005005|Drug|Alendronate|
16392304|NCT00004997|Drug|Leucovorin|
16392305|NCT00004993|Drug|Parathyroid hormone (hPTH 1-34)|
16392306|NCT00004992|Behavioral|Intensive lifestyle|
16392307|NCT00004992|Drug|Metformin|
16392308|NCT00004992|Drug|Placebo|
16392309|NCT00004990|Drug|Dexamethasone|
16392310|NCT00004988|Drug|VNP20009|
16392311|NCT00004984|Drug|Parenteral Insulin|Subcutaneous injections of recombinant human ultralente insulin in the morning and in the evening; the initial dose for each injection was 0.125 U per kilogram of body weight.
16392312|NCT00004984|Other|Close Observation|Study visits every 6 months including an oral glucose tolerance test
16392313|NCT00004984|Drug|Oral Insulin|Capsules oral insulin, 7.5 mg of recombinant human insulin crystals
16392314|NCT00004984|Drug|Placebo|Placebo for oral insulin
16392315|NCT00004983|Behavioral|diabetes self-management education|
16392316|NCT00004982|Drug|Combination Iron Chelation Therapy|
16392317|NCT00004980|Device|repetitive transcranial magnetic stimulation (rTMS)|a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
16392318|NCT00004980|Device|sham stimulation|"132 minutes of stimulation given at 80% motor threshold with coil tilted single wing 45 degrees away from scalp deliverd to TP3 site"
16392319|NCT00004854|Drug|Carvedilol|
16392320|NCT00004853|Biological|Filgrastim|5 microgram/kg/dose SC daily starting 24-36 hours after last dose of chemotherapy until post-nadir ANC >=10,000/microliter
16392321|NCT00004853|Biological|Filgrastim-SD/01|100 microgram/kg SC 24-36 hours after last dose of chemotherapy (single dose)
16392411|NCT00004762|Drug|cladribine|
16392412|NCT00004760|Behavioral|Exercise|
16392413|NCT00004759|Drug|methylprednisolone|
16392414|NCT00004759|Drug|tirilazad|
16392415|NCT00004758|Drug|carbamazepine|
16392416|NCT00004758|Drug|corticotropin|
16392417|NCT00004758|Drug|nitrazepam|
16392418|NCT00004758|Drug|pyridoxine|
16392419|NCT00004758|Drug|valproic acid|
16392420|NCT00004758|Procedure|Surgery|
16392421|NCT00004757|Drug|acyclovir|
16392322|NCT00004847|Drug|([18F]-DOPA)|is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, [18F]-DOPA PET is highly sensitive and specific for detection of PHEO/PGL67-69. However, there are only a few reports in the literature using [18F]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities.
16392323|NCT00004847|Drug|([18F]-6F-DA)|is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. [18F]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, [18F]-6F-DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of [18F]-6F-DA, the much faster disappearance of [18F]-6F-DA-derived radioactivity from the bloodstream and non-neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning.
16392324|NCT00004846|Drug|ABC/Gen-Probe/Chiron HIV-1/HCV 001|
16392325|NCT00004739|Drug|Antiretroviral therapy|
16392326|NCT00004845|Drug|Rofecoxib|
16392327|NCT00004845|Drug|Naproxen|
16392328|NCT00004734|Drug|pyridoxine|
16392329|NCT00004734|Drug|cyanocobalamin|
16392330|NCT00004734|Drug|folic acid multivitamin|
16392331|NCT00004733|Drug|levodopa|
16392332|NCT00004732|Procedure|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
16392333|NCT00004732|Device|Carotid Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.
16392334|NCT00004731|Drug|Coenzyme Q10|
16392335|NCT00004730|Drug|magnesium sulfate|
16392336|NCT00004729|Behavioral|Ketogenic diet|
16392337|NCT00004728|Drug|Warfarin|
16392338|NCT00004728|Drug|Aspirin|
16392339|NCT00004727|Drug|aspirin|
16392340|NCT00004727|Drug|ticlopidine|
16392341|NCT00004941|Drug|monoclonal antibody cA2|
16392342|NCT00004940|Drug|cysteine hydrochloride|
16392343|NCT00004939|Drug|,4-diaminopyridine|
16392344|NCT00004938|Drug|fluconazole|
16392345|NCT00004844|Procedure|tissue implantation|
16392346|NCT00004843|Procedure|parathyroidectomy|Standard parathyroidectomy with a bilateral approach
16392347|NCT00004843|Other|Observation|Usual care
16392348|NCT00004842|Drug|budesonide|Oral budesonide, 9 mg daily was administered for 1 year
16392349|NCT00004840|Drug|thyrotropin-releasing hormone|
16392350|NCT00004838|Drug|succimer|
16392351|NCT00004834|Drug|imipramine|
16392352|NCT00004834|Behavioral|cognitive-behavioral therapy|
16392353|NCT00004833|Drug|Immune globulin|
16392354|NCT00004832|Drug|3,4-diaminopyridine|
16392355|NCT00004831|Drug|cysteine hydrochloride|
16392356|NCT00004829|Drug|tobramycin|
16392357|NCT00004828|Drug|liothyronine I 131|
16392358|NCT00004827|Drug|docosahexaenoic acid|
16392359|NCT00004826|Drug|clozapine|
16392360|NCT00004825|Drug|recombinant human insulin-like growth factor I|
16392361|NCT00004817|Drug|phenytoin|
16392362|NCT00004817|Drug|valproate sodium|
16392363|NCT00004816|Drug|monoclonal antibody M-T412|
16392364|NCT00004815|Drug|growth hormone|
16392365|NCT00004814|Drug|copolymer 1|
16392366|NCT00004812|Behavioral|Exercise|
16392367|NCT00004811|Drug|itraconazole|
16392368|NCT00004810|Drug|-aminosalicylic acid|
16392369|NCT00004809|Procedure|gene therapy|
16392370|NCT00004808|Drug|fluconazole|
16392371|NCT00004807|Drug|dextromethorphan|
16392372|NCT00004807|Drug|topiramate|
16392373|NCT00004807|Drug|Donepezil|
16392374|NCT00004806|Genetic|Cystic fibrosis transmembrane conductance regulator|
16392375|NCT00004805|Behavioral|CPR instruction|
16392376|NCT00004804|Drug|interferon alfa|
16392377|NCT00004802|Drug|dichlorphenamide|
16392378|NCT00004801|Drug|monoclonal factor IX replacement therapy|
16392379|NCT00004800|Biological|diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis|
16392380|NCT00004800|Biological|diphtheria-tetanus vaccine|
16392381|NCT00004799|Biological|whole-cell pertussis vaccine|
16392382|NCT00004799|Biological|diphtheria-tetanus vaccine|
16392383|NCT00004797|Drug|fructose|
16392384|NCT00004797|Drug|placebo|
16392385|NCT00004796|Drug|lactulose|
16392386|NCT00004795|Drug|dehydroepiandrosterone|
16392387|NCT00004794|Drug|cidofovir|
16392388|NCT00004789|Drug|heme arginate|
16392389|NCT00004789|Drug|tin mesoporphyrin|
16392390|NCT00004787|Drug|filgrastim|
16392391|NCT00004786|Drug|iloprost|
16392392|NCT00004785|Drug|dexamethasone|
16392393|NCT00004785|Drug|methylprednisolone|
16392394|NCT00004784|Drug|methotrexate|
16392395|NCT00004784|Drug|ursodiol|
16392396|NCT00004779|Genetic|Ad5-CB-CFTR|
16392397|NCT00004778|Drug|betamethasone|
16392398|NCT00004778|Drug|dexamethasone|
16392399|NCT00004778|Drug|thyrotropin-releasing hormone|
16392400|NCT00004776|Drug|topiramate|
16392401|NCT00004772|Drug|Immune globulin|
16392402|NCT00004771|Drug|leuprolide|
16392403|NCT00004771|Drug|testosterone|
16392404|NCT00004770|Drug|thioctic acid|
16392405|NCT00004767|Drug|Sodium Benzoate|
16392406|NCT00004767|Drug|Sodium Phenylacetate|
16392407|NCT00004767|Drug|Sodium Phenylbutyrate|
16392422|NCT00004756|Procedure|Tailored educational program|
16392423|NCT00004756|Procedure|Educational materials|
16392424|NCT00004755|Drug|allopurinol|
16392425|NCT00004755|Drug|glucantime|
16392426|NCT00004754|Drug|epoprostenol|
16392427|NCT00004751|Procedure|Surgery|
16392428|NCT00004751|Procedure|Physical therapy|
16392429|NCT00004748|Drug|colchicine|
16392430|NCT00004748|Drug|methotrexate|
16392431|NCT00004748|Drug|ursodiol|
16392432|NCT00004747|Drug|mucoid exopolysaccharide P. aeruginosa immune globulin IV|
16392433|NCT00004744|Drug|immune globulin|
16392434|NCT00004740|Drug|isoniazid|
16392435|NCT00004705|Drug|amiloride|
16392436|NCT00004705|Drug|uridine|
16392437|NCT00004700|Drug|insulin-like growth factor I|
16392438|NCT00004699|Drug|insulin-like growth factor I|
16392439|NCT00004697|Drug|choline chloride|
16392440|NCT00004696|Drug|morphine|
16392441|NCT00004695|Drug|PEG-interleukin-2|
16392442|NCT00004694|Drug|heparin|
16392443|NCT00004690|Drug|monolaurin cream|
16392444|NCT00004689|Drug|amithiozone|
16392445|NCT00004689|Drug|clarithromycin|
16392446|NCT00004689|Drug|ethambutol|
16392447|NCT00004689|Drug|rifampin|
16392448|NCT00004689|Drug|streptomycin|
16392449|NCT00004688|Drug|carmustine|
16392450|NCT00004688|Drug|mercaptopurine|
16392451|NCT00004688|Drug|streptozocin|
16392452|NCT00004686|Drug|methotrexate|
16392453|NCT00004686|Drug|prednisone|
16392454|NCT00004685|Drug|albuterol|
16392455|NCT00004682|Drug|immune globulin|
16392456|NCT00004670|Procedure|pallidotomy|
16392457|NCT00004669|Drug|hydrocortisone|
16392458|NCT00004667|Drug|von Willebrand factor|
16392459|NCT00004665|Drug|dehydroepiandrosterone|
16392460|NCT00004664|Drug|megestrol|
16392461|NCT00004664|Behavioral|Exercise|
16392462|NCT00004662|Drug|dehydroepiandrosterone|
16392463|NCT00004660|Radiation|Radiotherapy|
16392464|NCT00004660|Radiation|Sham treatment|
16392465|NCT00004659|Procedure|irradiation|
16392466|NCT00004659|Procedure|radiosurgery|
16392467|NCT00004658|Drug|ribose|
16392468|NCT00004658|Drug|thymidine|
16392469|NCT00004658|Drug|uridine|
16392470|NCT00004656|Procedure|Metabolic assessment with body composition evaluation|
16392471|NCT00004654|Drug|soy protein isolate|
16392472|NCT00004652|Drug|pimozide|
16392473|NCT00004650|Drug|conjugated estrogens|
16392474|NCT00004650|Drug|Medroxyprogesterone|
16392475|NCT00004647|Drug|mexiletine|
16392476|NCT00004646|Drug|prednisone|
16392477|NCT00004645|Procedure|Plasma exchange|
16392478|NCT00004644|Drug|acyclovir|
16392479|NCT00004643|Drug|cytarabine|
16392480|NCT00004642|Drug|SDZ MSL-109|
16392481|NCT00004638|Procedure|pathogenesis study|
16392482|NCT00004637|Drug|Vitamin E|
16392483|NCT00004635|Drug|Thalidomide|Thalidomide 200 mg given orally every evening at 9pm. Treatment may continue indefinitely provided that there are no dose-limiting toxicity.
16392484|NCT00004635|Drug|leuprolide acetate|Injections of leuprolide once a month for six months.
16392485|NCT00004635|Drug|goserelin|Injections of Goserelin once a month for six months.
16392486|NCT00004635|Other|Placebo|Patients will receive the placebo if they initially received thalidomide. The starting dose of placebo 200 mg (four capsules of 100-50 mg capsules) orally once daily at bedtime.
16392487|NCT00004573|Drug|ganciclovir|
16392488|NCT00004572|Procedure|Sustacal challenge|
16392489|NCT00004569|Procedure|Non-invasive technique to diagnose and quantitate sleep-disordered breathing|
16392490|NCT00004567|Drug|Mycophenolate Mofetil|
16392491|NCT00004564|Drug|Clopidogrel|
16392492|NCT00004564|Drug|Atorvastatin|
16392493|NCT00004563|Drug|Cyclophosphamide|Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.
16392494|NCT00004563|Drug|Placebo|Matching gelcaps 25 mgs
16392495|NCT00004562|Drug|Beta adrenergic blockers|Participants will receive beta adrenergic blockers.
16392496|NCT00004562|Drug|Platelet inhibitors|Participants will receive platelet inhibitors.
16392497|NCT00004562|Procedure|PTCA and stents|Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.
16392498|NCT00004562|Drug|ACE Inhibitors|Participants will receive ACE inhibitors.
16392499|NCT00004561|Behavioral|exercise|
16392500|NCT00004560|Device|defibrillator|
16392501|NCT00004559|Behavioral|dietary polyunsaturated fatty acid|
16392502|NCT00004558|Behavioral|dietary n-3 polyunsaturated fatty acids|
16392503|NCT00004554|Drug|naltrexone (Revia)|100mg/day
16392504|NCT00004554|Drug|sertraline (Zoloft)|200mg/day
16392505|NCT00004554|Drug|Placebo|Placebo
16392506|NCT00004553|Procedure|Electromyography|
16392507|NCT00004552|Drug|acamprosate (Campral)|
16392508|NCT00004551|Drug|nicotine replacement patch|
16392509|NCT00004551|Behavioral|mood management|
16392510|NCT00004549|Procedure|Magnetic resonance imaging|
16392511|NCT00004547|Procedure|Surgery|Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected.
16392512|NCT00004547|Procedure|Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin|
16392588|NCT00001849|Drug|18F-DOPA|18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography (PET). Limited to 3 doses over the course of the study.
16392589|NCT00001849|Device|CT scan|CT scan of chest, abdomen, neck and /or pelvis
16392590|NCT00001849|Device|MRI|MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis
16392591|NCT00001849|Drug|18-FDG|FDG PET scan of body
16392513|NCT00004547|Drug|Postoperative dwell with paclitaxel and 5-FU|Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M^2) and 1 L of normal saline containing paclitaxel (125 mg/M^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.
16392514|NCT00004533|Drug|Adeno-associated virus-CFTR vector|
16392515|NCT00000436|Behavioral|Self-efficacy and muscle strength training|
16392516|NCT00000436|Procedure|High-intensity strength training|
16392517|NCT00001984|Drug|Alemtuzumab and DSG|Alemtuzumab was administered intravenously at 0.3 mg/kg/dose over 3 hr. Patients received one dose on each of days -1,+1,+3 and +5 relative to transplantation (total dose 1.2 mg/kg). Methylprednisolone was given prior to each dose to limit the cytokine release: 500 mg prior to dose 1, 125 mg prior to dose 2, and 60 mg prior to doses 3 and 4. Deoxyspergualin was dosed as follows. The first two patients received 4 mg/kg as a loading dose on the day of transplant and 2.5 mg/kg daily for 13 additional days (14 days of treatment; 36.5 mg/kg total dose). The next three patients received the same dosing regimen but it was initiated on postoperative day 12 to coincide with the resurgence of monocytes on days 12- 25.
16392518|NCT00000435|Drug|dnaJ peptide|dnaJP1 was taken in pill form at 25mg/day for 6 months
16392519|NCT00000435|Drug|None-placebo|placebo was taken in pill form at 25mg/day for 6 months
16392520|NCT00000434|Behavioral|Fit and Strong!|Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.
16392521|NCT00001972|Drug|15 O Water|
16392522|NCT00001967|Drug|HAART|
16392523|NCT00001964|Drug|Cyclosporine A|Cyclosporine A
16392524|NCT00001964|Drug|ATG|ATG
16392525|NCT00001964|Drug|MMF|MMF
16392526|NCT00001962|Drug|Daclizumab|Daclizumab, 1mg/kg, every 2 weeks for a total of 5 infusions.
16392527|NCT00001961|Procedure|MRI|
16392528|NCT00001960|Device|Pacemaker therapy|
16392529|NCT00001959|Drug|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
16392530|NCT00001958|Drug|Hydroxyurea|
16392531|NCT00001956|Procedure|Blood draw|
16392532|NCT00001956|Procedure|Oral surgery|
16392533|NCT00001956|Procedure|Tissue biopsy|
16392534|NCT00001955|Drug|Etanercept|
16392535|NCT00001955|Drug|Celecoxib|
16392536|NCT00001954|Drug|Etanercept|
16392537|NCT00001951|Drug|TMTDS|
16392538|NCT00001946|Procedure|Magnetic resonance angiography|
16392539|NCT00001941|Biological|daclizumab|
16392540|NCT00000433|Drug|Anti-Tumor Necrosis Factor|
16392541|NCT00000432|Behavioral|Education about disease prevention|
16392542|NCT00000431|Drug|PDGF-B/Ad5|This is a dose finding study to evaluate the safety of a single injection of PDGF dna in an adenoviral vector.
16392543|NCT00000430|Drug|Alendronate|
16392544|NCT00000430|Drug|Estrogen/progestin therapy|
16392545|NCT00000429|Drug|Calcium carbonate|
16392546|NCT00000428|Drug|Amitriptyline|Amitriptyline 25 mg po
16392547|NCT00000428|Drug|Amitriptyline plus Fluoxitine|Amitriptyline 25 mg po plus Fluoxitine 20 mg po
16392548|NCT00000427|Drug|Parathyroid hormone|
16392549|NCT00000427|Drug|Alendronate|
16392550|NCT00000111|Procedure|Oral mucosal graft|
16392551|NCT00000110|Procedure|magnetic resonance spectroscopy|
16392552|NCT00000110|Drug|dietary fat|
16392553|NCT00000108|Behavioral|Exercise|
16392554|NCT00000106|Device|Whole body hyperthermia unit|
16392555|NCT00000393|Drug|Peptide T|
16392556|NCT00000392|Drug|Peptide T|
16392557|NCT00000392|Drug|Placebo|
16392558|NCT00000391|Drug|Peptide T|
16392559|NCT00000390|Drug|Imipramine hydrochloride|
16392560|NCT00001934|Drug|Zenapax|
16392561|NCT00001933|Drug|Nefiracetam|
16392562|NCT00001926|Drug|O15|
16392563|NCT00001926|Device|Cadwell rTMS|
16392564|NCT00001925|Drug|Alcohol|
16392565|NCT00001923|Procedure|Transcranial magnetic stimulation|
16392566|NCT00001919|Drug|Hypericum (LI-160)|
16392567|NCT00001917|Drug|O15|
16392568|NCT00001917|Drug|[F-18] FP-TZTP|
16392569|NCT00001911|Drug|Interleukin-12|
16392570|NCT00001905|Drug|Interferon gamma|
16392571|NCT00001901|Drug|Etanercept|
16392572|NCT00001895|Drug|FDG|
16392573|NCT00001895|Drug|NH(3)|
16392574|NCT00001894|Procedure|pacemaker implantation|
16392575|NCT00001894|Procedure|percutaneous transluminal septal ablation (PTSA)|
16392576|NCT00001893|Drug|TNFR:Fc|
16392577|NCT00001880|Drug|methotrexate|CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given
16392578|NCT00001880|Drug|cyclosporin|CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given
16392579|NCT00001877|Drug|Pentoxifylline|
16392580|NCT00001873|Device|Isolex 300i plus MoAbs|
16392581|NCT00001870|Drug|Acetylcholine|
16392582|NCT00001865|Drug|Daclizumab|
16392583|NCT00001863|Drug|Leflunomide|
16392584|NCT00001862|Drug|Enbrel|
16392585|NCT00001860|Drug|Sandostatin LAR Depot versus transsphenoidal surgery|
16392586|NCT00001854|Drug|Ribavirin|
16392587|NCT00001849|Drug|Pentetreotide|Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.
16392592|NCT00001848|Drug|Raloxifene|
16392593|NCT00001842|Drug|Granulocyte colony-stimulating factor|
16392594|NCT00001842|Drug|Dexamethasone|
16392595|NCT00001835|Drug|Oxaliplatin|
16392596|NCT00001832|Drug|gp100:209-217 (210M)|"gp100 = gp100:209-217(210M) peptide - 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus gp100:209-217(210M) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
~MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections."
16392597|NCT00001832|Drug|Montanide ISA-51|MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
16392598|NCT00001832|Drug|IL-2|"125,000 IU/kg dose intravenous for 5 days for 6 weeks with 2 days rest per week.
~720,000 IU/kg intravenous every 8 hours for a maximum of 12 doses."
16392599|NCT00001832|Drug|MART-1:26-35(27L)|MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
16392600|NCT00001832|Biological|Abl cells|Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days
16392601|NCT00001832|Drug|Fludarabine|5x25 mg/m^2 intravenous
16392602|NCT00001832|Drug|Cyclophosphamide|2x30 mg/kg, 2x60 mg/kg intravenous
16392603|NCT00001832|Biological|GCSF (Growth colony stimulating factor)|Beginning on day 1 or 2, GCSF will be administered subcutaneously at a dose of 5mcg/kg/day (not to exceed 300 mcg/day. Filgrastim administration will continue daily until neutrophil count > 1.0 x10^9/L x 3 days or > 5.0 x10^9/L.
16392604|NCT00001832|Procedure|Apheresis|
16392605|NCT00001830|Drug|Th2 cells in allo HSCTT|
16392606|NCT00001830|Drug|Th2 Cells|
16392607|NCT00001827|Biological|aldesleukin|
16392608|NCT00001827|Biological|incomplete Freund's adjuvant|
16392609|NCT00001827|Biological|p53 peptide vaccine|
16392610|NCT00001827|Biological|sargramostim|
16392611|NCT00001827|Biological|therapeutic autologous dendritic cells|
16392612|NCT00001827|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16392613|NCT00001806|Other|Genetic Education and Counseling|Group Education and Counseling
16392614|NCT00001806|Other|Genetic Education and Counseling|Individual Education and Counlseing
16392615|NCT00001785|Drug|Recombinant human interferon beta-1a|
16392616|NCT00001784|Drug|Mexiletine|
16392617|NCT00001783|Drug|0-15 Water|
16392618|NCT00001781|Drug|CGP 77116|
16392619|NCT00001776|Device|Cadwell Rapid Rate Magnetic Stimulator|
16392620|NCT00001766|Drug|Amprenavir, Efavirenz, Abacavir, Nelfinavir, Ritonavir|
16392621|NCT00001765|Device|Nexell Isolex with T-cell Depletion|
16392622|NCT00001765|Device|Baxter isolex 300i|
16392623|NCT00001764|Drug|Mycophenolate Mofetil|
16392624|NCT00001758|Drug|Abacavir|
16392625|NCT00001758|Drug|Amprenavir|
16392626|NCT00001758|Drug|Efavirenz|
16392627|NCT00001750|Drug|Stemgen|
16392628|NCT00001749|Drug|Antithymocyte globulin|
16392629|NCT00001749|Drug|Cyclosporine|
16392630|NCT00001741|Drug|Losartan|
16392631|NCT00001737|Drug|Cyclosporin A Implant|
16392632|NCT00001729|Drug|Ribavirin|
16392633|NCT00001728|Drug|Fosamax (Alendronate)|
16392634|NCT00001725|Drug|Dextromethorphan|
16392635|NCT00001724|Drug|Flurbiprofen|
16392636|NCT00001723|Drug|Orlistat|Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
16392637|NCT00001723|Drug|Placebo|Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
16392638|NCT00001720|Drug|Alendronate|
16392639|NCT00001716|Drug|Nitric Oxide|
16392640|NCT00001716|Drug|Nitroglycerin|
16392641|NCT00001713|Drug|Recombinant Tissue Plasminogen Activator|
16392642|NCT00001713|Drug|Heparin|
16392643|NCT00001713|Drug|Warfarin|
16392644|NCT00001703|Biological|incomplete Freund's adjuvant|0.7 ml of ISA-51 (Montanide ISA-51 adjuvant, incomplete Freund's adjuvant) will be mixed with peptide alone and injected subcutaneously every four weeks for a total of four vaccinations.
16392645|NCT00001703|Biological|von Hippel-Lindau peptide vaccine|1000 micrograms administered subcutaneously every four weeks for a total of four vaccinations.
16392646|NCT00001698|Drug|Ketorolac Rinse|
16392647|NCT00001693|Drug|Celecoxib (SC-58635)|
16392648|NCT00001689|Drug|Vincristine|
16392649|NCT00001683|Drug|COL-3|
16392650|NCT00001676|Drug|SQ Fludarabine|
16392651|NCT00001666|Device|Cadwell High-Speed Magnetoelectric Stimulator|
16392652|NCT00001666|Device|Magpro High-Speed Magnetoelectric Stimulator|
16392653|NCT00001663|Device|Magstim Super Rapid Stimulator|
16392654|NCT00001662|Drug|CX516 (Ampalex)|
16392655|NCT00001656|Drug|Olanzapine|tablet; 5-20mg/day; 8 weeks
16392656|NCT00001656|Drug|Clozapine|tablet; 12.5-900mg/day; 8 weeks
16392657|NCT00001651|Other|[6,6-2H2]-glucose|[6,6-2H2]-glucose will be administered as a continuous IV infusion for one to five days.
16392658|NCT00001649|Drug|Valaciclovir|
16392659|NCT00001647|Procedure|White blood cell infusion|
16392660|NCT00001644|Drug|Indinavir|
16392661|NCT00001644|Drug|Zidovudine|
16392662|NCT00001644|Drug|Lamivudine|
16392663|NCT00001644|Drug|Nevirapine|
16392664|NCT00001644|Procedure|Blood testing|
16392665|NCT00001644|Procedure|Lymph node biospy|
16392666|NCT00001644|Procedure|Leukapheresis|
16392667|NCT00001637|Procedure|Blood cell transplantation|
16392668|NCT00001631|Procedure|Magnetic resonance imaging|
16392669|NCT00001630|Device|Isolex 300i|
16392670|NCT00001626|Drug|antithymocyte globulin|antithymocyte globulin
16392671|NCT00001626|Drug|cyclophosphamide|cyclophosphamide
16392672|NCT00001626|Drug|cyclosporine|cyclosporine
16392673|NCT00001623|Procedure|Allogeneic Bone Marrow Transplant|
16392674|NCT00001601|Procedure|Electrocardiogram|
16392675|NCT00001601|Procedure|Biopsies|
16392676|NCT00001601|Procedure|Diagnostic imaging|
16392677|NCT00001599|Drug|Thalidomide|
16392678|NCT00001598|Drug|Dehydroepiandrosterone|
16392679|NCT00001596|Drug|Pirfenidone|Treatment with pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
16392680|NCT00001596|Drug|Placebo|Placebo (3 pills), three times daily.
16392681|NCT00001586|Biological|Rituximab|Rituxan
16392682|NCT00001586|Drug|Fludarabine phosphate|Fludara
16392683|NCT00001586|Other|Leukemic or stroma cells|Patients are eligible to donate cells for the purpose of analyzing leukemic cells. Cells can be donated by apheresis (e.g. 60-90 minute intravenous technique), lymph node biopsy (e.g. 3 biopsy/excision of lymph nodes)bone marrow biopsy (e.g. 2-4 separate bone marrow biopsies), and bone marrow aspiration (e.g. 3 to 5cc of marrow per aspirate).
16392684|NCT00001576|Drug|Melphalan|
16392685|NCT00001576|Drug|Floxuridine|
16392686|NCT00001576|Drug|Leucovorin|
16392687|NCT00001575|Biological|Y-90 Humanized Anti-Tac|10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).
16392688|NCT00001575|Drug|Calcium-DTPA|Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body
16392689|NCT00001572|Drug|Id-KLH Vaccine|
16392690|NCT00001572|Drug|QS-21 (Stimulation-QS-21) Drug|
16392691|NCT00001569|Drug|Cisplatin|
16392692|NCT00001569|Drug|Paclitaxel|
16392693|NCT00001569|Drug|5-FU|
16392694|NCT00001568|Drug|2-Fluoro-2-deoxyglucose|
16392695|NCT00001567|Drug|Roferon-A|
16392696|NCT00001566|Biological|therapeutic autologous dendritic cells|3 syringes containing 1 x 10^6peptide pulsed dendritic cells
16392697|NCT00001566|Drug|indinavir sulfate|Oral dose, 350 mg/m^2 administered every 8 hours. Maximum dose is 800 mg every 8 hours.
16392698|NCT00001566|Procedure|peripheral blood stem cell transplantation|Harvested autologous T cells, minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
16392699|NCT00001564|Drug|EF-1 Peptide|
16392700|NCT00001564|Drug|EF-2 Peptide|
16392701|NCT00001564|Drug|PXFK Peptide|
16392702|NCT00001564|Drug|E7 Peptide|
16392703|NCT00001564|Drug|IL-2|
16392704|NCT00001564|Drug|IL-4|
16392705|NCT00001564|Drug|GM-CSF|
16392706|NCT00001564|Drug|CD40 Ligand|
16392710|NCT00001561|Drug|Myeloma Immunoglobulin Idiotype Vaccine-KLH|
16392711|NCT00001561|Drug|GM-CSF|
16392712|NCT00001550|Drug|IVIg|
16392713|NCT00001545|Device|Magstim Super Rapid Magnetic Stimulator|
16392714|NCT00001545|Device|Cadwell MES-10|
16392715|NCT00001535|Drug|Syngeneic Lymphocytes (CD4+) Cultured with OKT3 (Ortho) and Interleukin-2 (Chiro|
16392716|NCT00001534|Drug|Losartan|
16392717|NCT00001526|Drug|Daclizumab (Zenapax)|
16392718|NCT00001524|Drug|Thalidomide|
16392723|NCT00001515|Device|virtual bronchoscopy|
16392724|NCT00001512|Drug|Id-KLH Vaccine|
16392725|NCT00001512|Drug|GM-CSF|
16392726|NCT00001507|Drug|Monoclonal Antibody 3A1|
16392727|NCT00001507|Drug|Monoclonal Antibody 95-5-49|
16392728|NCT00001507|Drug|Monoclonal Antibody 95-6-22|
16392729|NCT00001507|Device|Baxter Isolex 3001 Stem Cell Selection System|
16392730|NCT00001507|Device|Ceprate SC|
16392731|NCT00001504|Drug|9-cis-Retinoic Acid|
16392732|NCT00001487|Drug|Dehydroepiandrosterone|
16392733|NCT00001483|Drug|buproprion (Wellbutrin)|
16392734|NCT00001483|Drug|sertraline (Zoloft)|
16392735|NCT00001483|Drug|venlafaxine (Effexor)|
16392739|NCT00001476|Drug|Gene Therapy Method for CGD|
16392740|NCT00001476|Device|Isolex 300i Magnetic Cell Selector|
16392741|NCT00001475|Drug|IL-2 plus Anti-TNF or Thalidomide|
16392742|NCT00001474|Drug|Interleukin-2|
16392743|NCT00001460|Behavioral|inpatient evaluation and management|
16392744|NCT00001457|Drug|Lamivudine|
16392745|NCT00001444|Drug|7-hydroxystaurosporine (UCN-01)|
16392746|NCT00001442|Drug|paclitaxel concurrent with radiation therapy|
16392747|NCT00001440|Procedure|Autologous T cells|
16392748|NCT00001440|Drug|Interleukin-2|
16392749|NCT00001430|Procedure|PBSC|
16392750|NCT00001430|Drug|IL-2|
16392751|NCT00001430|Drug|EPOCH II|
16392752|NCT00001426|Drug|Cyclophosphamide|
16392753|NCT00001426|Drug|Paclitaxel|
16392754|NCT00001426|Drug|Cisplatin|
16392755|NCT00001426|Drug|G-CSF|
16392756|NCT00001410|Drug|Lysodase|
16392757|NCT00001409|Drug|Interleukin-2|
16392758|NCT00001407|Drug|Interferon Gamma|
16392759|NCT00001399|Drug|Transduced CD34+ Cells|
16392760|NCT00001398|Drug|Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF)|
16392761|NCT00001396|Device|Paragon Pacemaker|
16392762|NCT00001386|Drug|PCLUS 3-18 MN|
16392763|NCT00001386|Drug|PCLUS 6.1 MN|
16392766|NCT00001368|Procedure|cytokine and leukocyte activation profile|
16392767|NCT00001359|Drug|Penicillin or Placebo|
16392768|NCT00001357|Drug|Interleukin-2|
16392769|NCT00001354|Drug|Interleukin-2/Zidovudine (AZT)|
16392770|NCT00001353|Drug|Genetically Marked Syngeneic T Lymphocytes|
16392771|NCT00001343|Drug|Humatrope|
16392772|NCT00001343|Drug|Oxandrolone|
16392773|NCT00001339|Drug|doxorubicin, vincristine, and etoposide with mitotane|
16392776|NCT00001335|Drug|ADR-529|
16392777|NCT00001335|Drug|Topotecan|
16392778|NCT00001335|Drug|G-CSF|
16392779|NCT00001328|Drug|Cytovene (Ganciclovir Sodium)|
16392780|NCT00001328|Device|G1TKSVNa.53 Producer Cell Line|
16392781|NCT00001325|Drug|18 FDG|
16392782|NCT00001322|Drug|Leuprolide Acetate 3.75|Each woman will be administered Lupron for two months only.
16392783|NCT00001322|Drug|Estrogel|After the first month of Lupron treatment when ovarian suppression has been achieved, we will administer 2-3 applications (approximately 6.0 9.0 mg estradiol gel (open label)) once a day for four weeks.
16392784|NCT00001322|Drug|Progesterone|After the four weeks of estradiol treatment, all women will receive one week of progesterone suppositories (200 mg twice a day) to precipitate a progesterone withdrawal-induced menses.
16392786|NCT00001307|Drug|Oxygen-15 Water|
16392787|NCT00001307|Drug|Capsaicin|
16392788|NCT00001305|Drug|Humatrope|Patients receive a subcutaneous injection.
16392789|NCT00001304|Drug|Synthetic Human Parathyroid Hormone 1-34|twice daily subcutaneous injections
16392790|NCT00001304|Drug|Calcitriol & Calcium|Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation
16392791|NCT00001303|Drug|Reference Endotoxin|
16392792|NCT00001303|Drug|Inhaled Nitric Oxide|
16392793|NCT00001302|Drug|PSC 833|
16392794|NCT00001288|Drug|15 O Water|
16392795|NCT00001288|Drug|FDG|
16392796|NCT00001282|Drug|Zidovudine (AZT) & Interleukin-2 (IL2)|
16392797|NCT00001277|Drug|68Ga-Dotatate|Radiotracer used with PET/CT scans
16392798|NCT00001277|Drug|18F-DOPA|Radiotracer used with PET/CT scans
16392799|NCT00001266|Drug|Suramin|
16392800|NCT00001262|Drug|Copper Histidine|
16392801|NCT00001261|Drug|Gamma Globulin|
16392802|NCT00001259|Drug|Leuprolide|3.75mg IMQM
16392803|NCT00001259|Drug|Estradiol Patches|0.1 mg/day of estradiol via skin patch (Estraderm) for a period of five weeks.
16392804|NCT00001259|Drug|Progesterone|progesterone suppositories (200 mgs twice daily)
16392805|NCT00001256|Drug|prednisone and methotrexate|
16392806|NCT00001255|Drug|ADA PBSC|
16392807|NCT00001255|Drug|ADA Umbilical Cord Blood Cells|
16392808|NCT00001255|Drug|Transduced Lymphocytes|
16392809|NCT00001253|Behavioral|cognitive tests and scales|
16392810|NCT00001251|Drug|Mafosfamide|
16392811|NCT00001250|Drug|preoperative dose intense chemotherapy (FLAC/G-CSF)|
16392812|NCT00001234|Genetic|human glucocerebrosidase cDNA|
16392813|NCT00001228|Drug|Interferon|
16392814|NCT00001221|Drug|Growth Hormone (Humatrope)|
16392815|NCT00001213|Drug|Cysteamine|
16392816|NCT00001212|Drug|prednisone|
16392817|NCT00001212|Drug|cyclophosphamide|
16392818|NCT00001212|Drug|cyclosporin A|
16392819|NCT00001202|Drug|Spironolactone|
16392820|NCT00001202|Drug|Testolactone|
16392821|NCT00001202|Drug|Deslorelin|
16392822|NCT00001197|Drug|Hydroxyurea|
16392823|NCT00001191|Drug|Pantoprazole|
16392824|NCT00001191|Drug|Omeprazole|
16392825|NCT00001182|Procedure|current standard of care treatments|
16392826|NCT00001181|Drug|Testolactone|
16392827|NCT00001180|Drug|Ovine Corticotropin-Releasing Hormone (oCRH)|
16392828|NCT00001165|Drug|combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin|
16392829|NCT00001155|Drug|cyclophosphamide|
16392830|NCT00001151|Drug|1,25-Dihydroxycholecalciferol|Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day.
16392831|NCT00001146|Drug|Ethyl Eicosapentaenoic Acid|
16392832|NCT00001146|Drug|OmegaBrite|
16392833|NCT00001145|Drug|Bacteriophage|
16392834|NCT00001145|Drug|rhuCD40L|
16392835|NCT00001145|Drug|KLH|
16392836|NCT00001144|Drug|Modified bone marrow stem cell transplantation|
16392837|NCT00000426|Drug|Calcium supplement|
16392838|NCT00000425|Drug|Nonsteroidal anti-inflammatory drugs (NSAIDs)|
16392839|NCT00000425|Drug|Acetaminophen|
16392840|NCT00000424|Procedure|Tidal lavage vs. sham lavage of the knee|
16392841|NCT00000423|Behavioral|Social support group|
16392842|NCT00000423|Behavioral|Social support and education group|
16392843|NCT00000422|Behavioral|Cognitive-behavioral psychotherapy and physical exercise|
16392844|NCT00000421|Drug|Prednisone|
16392845|NCT00000421|Drug|Placebo|
16392846|NCT00000420|Drug|Ortho-Novum 777|
16392847|NCT00000419|Drug|Premarin and Provera|
16392848|NCT00000418|Procedure|Psychosocial intervention|
16392849|NCT00000417|Procedure|Counseling intervention|
16392850|NCT00000417|Device|Informational film|
16392851|NCT00000416|Other|Rehabilitation counseling|Provided in 2 in-person meetings and in follow-up phone calls
16392852|NCT00000415|Procedure|Physical activity|
16392853|NCT00000415|Drug|Calcium supplement|
16392854|NCT00000414|Behavioral|Arthritis Self-Management Program|
16392855|NCT00000414|Behavioral|SMART Program|
16392856|NCT00000413|Behavioral|Psychoeducational program|
16392857|NCT00000412|Drug|Alendronate|
16392858|NCT00000412|Drug|Calcitriol|
16392859|NCT00000412|Drug|Placebo Alendronate|
16392860|NCT00000412|Drug|Placebo Calcitriol|
16392861|NCT00000411|Procedure|Decompressive laminectomy|Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.
16392862|NCT00000411|Other|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
16392863|NCT00000410|Procedure|Diskectomy|The surgeon will leave the nerve root freely mobile and undamaged following the procedure. During the procedure, the surgeon may consider using loop magnification or a microscope. The surgical incision will be midline and, after reflecting the paraspinous muscles, the interlaminar level will be identified and entered. The nerve root will be clearly identified and mobilized and then gently retracted to prepare for the discectomy. Removal of the medial border of the superior facet may, in some cases, be necessary in order to have a clear view of the lateral border of the involved nerve root. Following the clear view of the nerve root and mobilization, the IDH will be approached by making a small annular incision if necessary, the fragment of disc will then be removed (i.e., limited disc excision). A search of the canal will follow removal of the fragment, along with probing of the intervertebral-foramen for residual disc or bony pathology.
16392864|NCT00000410|Procedure|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
16392865|NCT00000409|Procedure|Decompressive laminectomy|Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis
16392866|NCT00000409|Other|Non-surgical treatments|Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated. Any non-operative therapies other than these are accepted and collected as data.
16392867|NCT00000409|Procedure|Fusion--Instrumented|In addition to decompressive laminectomy, additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
16392868|NCT00000409|Procedure|Fusion-Non-instrumented|additional bilateral non-instrumented or instrumented, i.e., posterior pedicle fixation, posterolateral fusion with autogenous bone grafting (utilizing iliac crest harvested from between the tables and/or local bone) will be performed between the transverse processes and the lateral portion of the superior facets of the involved levels.
16392869|NCT00000408|Procedure|Patient education evaluation|
16392870|NCT00000407|Behavioral|Vocational counseling intervention|
16392871|NCT00000407|Behavioral|Reading materials for control participants|
16392872|NCT00000407|Behavioral|Standard of care|No education or behavioral intervention
16392873|NCT00000406|Procedure|Progressive resistance exercise|
16392874|NCT00000405|Procedure|Exercise intervention|
16392875|NCT00000404|Behavioral|Patient education in self-care of knee OA|
16392876|NCT00000403|Drug|Doxycycline|
16392877|NCT00000402|Drug|Calcium|
16392878|NCT00000401|Drug|Oral bovine type II collagen|Drug can be interrupted or stopped for suspected adverse events.
16392879|NCT00000400|Drug|Human parathyroid hormone [hPTH-(1-34)]|37 mcg once daily by self-administered sc injection
16392880|NCT00000400|Drug|alendronate|70 mg/week by oral route
16392881|NCT00000399|Drug|Hormone replacement therapy|
16392882|NCT00000399|Procedure|Strength training|
16392883|NCT00000398|Behavioral|Coping skills training|
16392884|NCT00000398|Behavioral|Physical exercise training|
16392885|NCT00000398|Behavioral|Coping skills training plus physical exercise training|
16392886|NCT00000397|Behavioral|Behavioral insomnia therapy|
16392887|NCT00000396|Behavioral|Patient self-care education|
16392888|NCT00000395|Drug|Methotrexate|
16392889|NCT00000395|Dietary Supplement|Folinic acid|
16392890|NCT00000395|Dietary Supplement|Folic acid|
16392891|NCT00000394|Procedure|Acupuncture therapy|
16392892|NCT00000105|Biological|Intracel KLH Vaccine|Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
16392893|NCT00000105|Biological|Biosyn KLH|Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
16392894|NCT00000105|Drug|Montanide ISA51|Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
16392895|NCT00000105|Biological|Tetanus toxoid|Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
16392896|NCT00000104|Procedure|ERP measures of attention and memory|
16392897|NCT00000102|Drug|Nifedipine|
16392898|NCT00000458|Drug|sertraline (Zoloft)|
16392899|NCT00000458|Behavioral|cognitive behavior therapy|
16392900|NCT00000457|Drug|bupropion (Wellbutrin)|"1 pill in the am of 150 mg of Bupropion
~1 pill (150 mg) in the AM and one in the PM for a total of 300 mg per day for subsequent 44 weeks."
16392901|NCT00000457|Drug|Placebo|placebo pill to match (look alike) the 150 mg pill of the bupropion given in the am for 3 days and then two pills (one in the morning and one at night) for the subsequent 44 mg.
16392902|NCT00000456|Drug|naltrexone (Revia)|
16392903|NCT00000456|Behavioral|cognitive behavior therapy|
16392904|NCT00000456|Behavioral|motivational enhancement therapy|
16392905|NCT00000455|Drug|naltrexone|
16392906|NCT00000454|Drug|nicotine replacement patch|
16392907|NCT00000452|Drug|naltrexone (Revia)|
16392908|NCT00000452|Behavioral|Compliance Enhancement Tech.|
16392909|NCT00000452|Behavioral|Cognitive Behavior Therapy|
16392910|NCT00000451|Drug|sertraline|16 week outpatient study
16392911|NCT00000451|Drug|naltrexone|16 week outpatient study
16392912|NCT00000450|Drug|Naltrexone Tablet|
16392913|NCT00000450|Drug|Matched Placebo Tablet|
16392914|NCT00000449|Drug|naltrexone (Revia)|
16392915|NCT00000449|Behavioral|cognitive behavioral therapy|
16392916|NCT00000449|Behavioral|cue exposure treatment|
16392917|NCT00000448|Drug|naltrexone|Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
16392918|NCT00000448|Drug|Placebo|A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
16392919|NCT00000447|Drug|naltrexone (Revia)|
16392920|NCT00000447|Drug|nicotine replacement patch|
16392921|NCT00000446|Drug|sertraline (Zoloft)|
16392922|NCT00000445|Drug|naltrexone (Revia)|
16392923|NCT00000444|Drug|nicotine replacement patch|
16392924|NCT00000443|Drug|ondansetron (Zofran)|
16392925|NCT00000442|Drug|naltrexone (Revia)|
16392926|NCT00000441|Drug|lorazepam (Ativan)|
16392927|NCT00000441|Drug|carbamazepine (Tegretol)|
16392928|NCT00000440|Drug|naltrexone (Revia)|
16392929|NCT00000440|Drug|sertraline (Zoloft)|
16392930|NCT00000439|Drug|sodium valproate|subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
16392931|NCT00000438|Drug|naltrexone (Revia)|
16392932|NCT00000437|Drug|Naltrexone Tablet and Nicotine Patch|
16392933|NCT00000437|Drug|Naltrexone Tablet and Placebo Patch|
16392934|NCT00000437|Drug|Placebo Tablet and Nicotine Patch|
16392935|NCT00000437|Drug|Placebo Tablet and Placebo Patch|
16392936|NCT00000389|Drug|Fluvoxamine|
16392937|NCT00000388|Behavioral|Psychosocial treatment|
16392938|NCT00000388|Drug|Anti-ADHD medication|
16392939|NCT00000388|Behavioral|Assessment-and-Referral|
16392940|NCT00000387|Behavioral|Self-management therapy|Behavioral
16392941|NCT00000387|Behavioral|Self-management therapy|
16392942|NCT00000386|Behavioral|Exposure and Response Prevention|
16392943|NCT00000386|Behavioral|Family Treatment Program|
16392944|NCT00000386|Behavioral|Relaxation Training|
16392945|NCT00000386|Behavioral|Behavior therapy|
16392946|NCT00000386|Behavioral|Family Counseling|
16392947|NCT00000385|Drug|Lithium|Lithium 600 mg to 2700 mg per day
16392948|NCT00000385|Drug|Placebo|Matching placebo
16392949|NCT00000384|Behavioral|Cognitive Behavior Therapy|
16392950|NCT00000384|Behavioral|Educational Support|
16392951|NCT00000384|Drug|Sertraline|
16392952|NCT00000383|Behavioral|Trauma-Focused CBT|Structured skills, exposure, trauma-specific interventions
16392953|NCT00000383|Behavioral|Child-Centered Therapy|Client-directed supportive interventions
16392954|NCT00000382|Behavioral|Infant-Parent Psychotherapy|
16392955|NCT00000382|Behavioral|Child Protective Services|
16392956|NCT00000382|Behavioral|Psychoeducational Home Visitation|
16392957|NCT00000382|Behavioral|Parent Education|
16392958|NCT00000381|Drug|Fluoxetine|
16392959|NCT00000380|Drug|GHRH|
16392960|NCT00000379|Drug|Fluoxetine|
16392961|NCT00000379|Behavioral|EMDR|
16392962|NCT00000378|Drug|Sertraline|12 week trial dose up to 200mgs
16392963|NCT00000378|Drug|Nortriptyline|12 week trial dose adjusted to therapeutic level
16392964|NCT00000377|Drug|Nortriptyline|
16392965|NCT00000376|Behavioral|Cognitive therapy|
16392966|NCT00000376|Drug|Desipramine|
16392967|NCT00000375|Drug|Nortriptyline-lithium (NOR-Li)|
16392968|NCT00000375|Procedure|Bilateral electroconvulsive therapy (ECT)|
16392969|NCT00000375|Drug|Continuation therapy|
16392970|NCT00000375|Behavioral|Continuation ECT|
16392971|NCT00000374|Drug|Olanzapine|The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.
16392972|NCT00000374|Drug|Risperidone|The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.
16392973|NCT00000373|Drug|olanzapine + fluoxetine|
16392974|NCT00000373|Drug|placebo + fluoxetine|
16392975|NCT00000372|Drug|D-cycloserine|
16392976|NCT00000372|Drug|Glycine|
16392977|NCT00000372|Drug|Clozapine|
16392978|NCT00000372|Drug|Placebo|
16392979|NCT00000371|Drug|D-cycloserine|50 mg/daily by mouth
16392980|NCT00000371|Drug|Placebo|50 mg/day of placebo by mouth
16392981|NCT00000370|Behavioral|Cognitive behavior therapy|
16392982|NCT00000370|Behavioral|Performance-based exposure therapy|
16392983|NCT00000370|Behavioral|Psychosocial intervention|
16392984|NCT00000369|Behavioral|Individual psychotherapy|
16392985|NCT00000369|Drug|Lithium carbonate|
16392986|NCT00000368|Behavioral|Cognitive behavior therapy|
16392987|NCT00000368|Drug|Paroxetine or other medication - algorithm used|
16392988|NCT00000367|Drug|Treatment of depression|
16392989|NCT00000367|Behavioral|Suicide prevention intervention|
16392990|NCT00000367|Drug|Suicide prevention treatment|
16392991|NCT00000363|Drug|Antihistamine|
16392992|NCT00000363|Drug|Corticosteroid|
16392993|NCT00000362|Behavioral|Chin-down position|
16392994|NCT00000362|Behavioral|Thickened liquid administration|
16392995|NCT00000361|Drug|Corticosteroids|
16392996|NCT00000361|Drug|Methotrexate|
16392997|NCT00000359|Behavioral|Canalith repositioning maneuver (Epley maneuver)|Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.
16392998|NCT00000359|Behavioral|Semont maneuver|Sidelying maneuver, flip over 180 deg, sit up.
16392999|NCT00000359|Behavioral|Brandt-Daroff exercises|Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.
16393000|NCT00000359|Behavioral|Vestibular habituation exercises|Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.
16393001|NCT00000359|Behavioral|ShamManeuver|Passive movement of the head
16393002|NCT00000180|Drug|AIT-082|
16393003|NCT00000179|Drug|Trazodone|
16393004|NCT00000179|Drug|Haloperidol|
16393005|NCT00000178|Drug|Prednisone|
16393006|NCT00000177|Drug|Estrogen|
16393007|NCT00000176|Drug|Estrogen|
16393008|NCT00000176|Drug|Estrogen and Progesterone|
16393009|NCT00000175|Drug|Estrogen|
16393010|NCT00000175|Drug|Testosterone|
16393011|NCT00000174|Drug|Rivastigmine|
16393012|NCT00000173|Drug|Donepezil|
16393013|NCT00000173|Drug|Vitamin E|
16393014|NCT00000172|Drug|Galantamine|
16393015|NCT00000171|Drug|Melatonin|
16393016|NCT00000623|Drug|Deferoxamine|
16393017|NCT00000623|Drug|Deferiprone|
16393018|NCT00000623|Drug|Arginine|
16393019|NCT00000623|Drug|Sildenafil|
16393020|NCT00000623|Drug|Decitabine|
16393021|NCT00000621|Drug|all trans retinoic acid|
16393022|NCT00000621|Drug|13 cis retinoic acid|
16393023|NCT00000621|Drug|placebo|
16393024|NCT00000620|Drug|Anti-hyperglycemic Agents|Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%).
16393025|NCT00000620|Drug|Anti-hypertensive Agents|Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).
16393026|NCT00000620|Drug|Blinded fenofibrate or placebo plus simvastatin|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.
16393027|NCT00000619|Procedure|catheterization, Swan-Ganz|
16393028|NCT00000617|Drug|azithromycin|
16393029|NCT00000616|Behavioral|diet, sodium-restricted|
16393030|NCT00000616|Behavioral|diet, fat-restricted|
16393031|NCT00000616|Behavioral|exercise|
16393032|NCT00000616|Behavioral|diet, reducing|
16393033|NCT00000616|Behavioral|alcohol drinking|
16393034|NCT00000615|Behavioral|diet, reducing|
16393035|NCT00000614|Drug|warfarin|
16393036|NCT00000613|Behavioral|dietary supplements|
16393037|NCT00000613|Drug|genistein|
16393038|NCT00000613|Behavioral|diet, soy proteins|
16393039|NCT00000612|Drug|estrogens, conjugated|
16393040|NCT00000612|Behavioral|diet, soy proteins|
16393041|NCT00000612|Behavioral|dietary supplements|
16393042|NCT00000611|Drug|hormone replacement therapy|
16393043|NCT00000611|Drug|estrogens|
16393044|NCT00000611|Drug|progestins|
16393045|NCT00000611|Drug|estrogen replacement therapy|
16393046|NCT00000611|Behavioral|diet, fat-restricted|
16393047|NCT00000611|Drug|calcium|
16393048|NCT00000611|Drug|vitamin D|
16393049|NCT00000611|Behavioral|dietary supplements|
16393050|NCT00000610|Drug|magnesium|
16393051|NCT00000609|Drug|amiodarone|
16393052|NCT00000609|Device|defibrillators, implantable|
16393053|NCT00000608|Behavioral|diet, fat-restricted|
16393054|NCT00000608|Behavioral|diet, sodium-restricted|
16393055|NCT00000607|Device|Left ventricular assist device|A type of implantable heart pump
16393056|NCT00000607|Device|Optimal medical therapy|(non-experimental) One possibility in handling Heart failure effectively is optimal medicine therapy. The most popular treatment medications at present are ACE Inhibitors and Beta Blockers. The result is the heart being able to pump more effectively and allowing blood to circulate freely.
16393057|NCT00000606|Procedure|Lung volume reduction surgery|
16393058|NCT00000605|Drug|hormone replacement therapy|
16393059|NCT00000605|Drug|estrogens|
16393060|NCT00000605|Drug|medroxyprogesterone|
16393061|NCT00000604|Procedure|cardiopulmonary bypass|
16393062|NCT00000604|Procedure|heart arrest, induced|
16393063|NCT00000603|Procedure|stem cell transplantation|
16393064|NCT00000602|Drug|hydroxyurea|
16393065|NCT00000601|Drug|estrogen replacement therapy|
16393066|NCT00000601|Drug|estrogens|
16393067|NCT00000601|Drug|progesterone|
16393068|NCT00000601|Drug|hormone replacement therapy|
16393069|NCT00000600|Drug|Vitamin E|
16393070|NCT00000600|Drug|Vitamin C|
16393071|NCT00000599|Drug|colestipol|
16393072|NCT00000599|Drug|niacin|
16393073|NCT00000599|Behavioral|diet, fat-restricted|
16393074|NCT00000598|Behavioral|diet, fat-restricted|
16393075|NCT00000598|Behavioral|exercise|
16393076|NCT00000597|Drug|antilymphocyte serum|
16393077|NCT00000597|Drug|nandrolone|
16393078|NCT00000596|Drug|prednisone|
16393079|NCT00000596|Drug|cyclophosphamide|
16393080|NCT00000596|Drug|dapsone|
16393081|NCT00000595|Drug|deferoxamine|
16393082|NCT00000594|Drug|cholestyramine|
16393083|NCT00000593|Procedure|blood transfusion|
16393084|NCT00000592|Procedure|blood transfusion|
16393085|NCT00000591|Procedure|lymphocyte depletion|
16393086|NCT00000590|Drug|immunoglobulins|
16393087|NCT00000589|Procedure|platelet transfusion|
16393088|NCT00000588|Drug|chelation therapy|
16393089|NCT00000587|Procedure|erythropoietin, recombinant|
16393090|NCT00000586|Drug|hydroxyurea|
16393091|NCT00000585|Drug|penicillin|
16393092|NCT00000584|Drug|immunoglobulins|
16393093|NCT00000583|Biological|hepatitis B vaccines|
16393094|NCT00000582|Drug|factor ix|
16393095|NCT00000581|Procedure|leukocyte transfusions|
16393096|NCT00000580|Drug|immunoglobulins, intravenous|
16393097|NCT00000579|Procedure|Low Tidal Volume Ventilation|
16393098|NCT00000579|Procedure|Positive End-Expiratory Pressure|
16393099|NCT00000579|Drug|Lysofylline|
16393100|NCT00000579|Drug|Methylprednisolone|
16393101|NCT00000579|Drug|Ketoconazole|
16393102|NCT00000579|Procedure|Fluid Management|
16393103|NCT00000579|Procedure|Pulmonary Artery Catheter|
16393104|NCT00000578|Drug|theophylline|
16393105|NCT00000578|Drug|beclomethasone|
16393106|NCT00000577|Drug|Albuterol|
16393107|NCT00000577|Drug|Colchicine|
16393108|NCT00000577|Drug|Adrenal Cortex Hormones|
16393109|NCT00000577|Drug|Adrenergic-Beta Agonists|
16393110|NCT00000576|Drug|beclomethasone|
16393111|NCT00000575|Drug|Placebo|Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
16393112|NCT00000575|Drug|Nedocromil|Four 2 mg puffs bid + two 90 Og puffs albuterol prn
16393113|NCT00000575|Drug|Budesonide|Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
16393114|NCT00000574|Drug|ibuprofen|
16393115|NCT00000573|Procedure|enteral nutrition|
16393116|NCT00000572|Procedure|positive-pressure ventilation|Detailed computer protocol controlled positive pressure ventilation
16393117|NCT00000572|Procedure|extracorporeal membrane oxygenation (CO2 removal)|Detailed computer protocol controlled Extracorporeal CO2 Removal with reduced positive pressure ventilation
16393118|NCT00000571|Device|ventilators, negative pressure|
16393119|NCT00000570|Drug|pulmonary surfactant|
16393120|NCT00000569|Drug|triamcinolone|1200 micrograms of triamcinolone in daily divided doses
16393121|NCT00000569|Other|Placebo|Placebo
16393122|NCT00000568|Behavioral|smoking cessation|
16393123|NCT00000568|Drug|ipratropium|
16393124|NCT00000567|Procedure|high-frequency ventilation|
16393125|NCT00000566|Procedure|ventilation-perfusion ratio|
16393126|NCT00000566|Procedure|angiography|
16393127|NCT00000565|Procedure|intermittent positive-pressure breathing|
16393128|NCT00000564|Procedure|oxygen inhalation therapy|
16393129|NCT00000563|Drug|dexamethasone|
16393130|NCT00000562|Procedure|extracorporeal membrane oxygenation|
16393131|NCT00000561|Device|pacemaker, artificial|
16393132|NCT00000560|Drug|adrenergic beta antagonists|
16393133|NCT00000559|Drug|estrogen replacement therapy|
16393134|NCT00000559|Drug|hormone replacement therapy|
16393135|NCT00000559|Drug|estradiol|
16393136|NCT00000559|Drug|medroxyprogesterone|
16393137|NCT00000558|Drug|angiotensin-converting enzyme inhibitors|
16393138|NCT00000557|Behavioral|social support|
16393139|NCT00000556|Drug|amiodarone|
16393140|NCT00000556|Drug|sotalol|
16393141|NCT00000556|Drug|propafenone|
16393142|NCT00000556|Drug|flecainide|
16393143|NCT00000556|Drug|quinidine|
16393144|NCT00000556|Drug|moricizine|
16393145|NCT00000556|Drug|disopyramide|
16393146|NCT00000556|Drug|procainamide|
16393147|NCT00000556|Drug|adrenergic beta antagonists|
16393148|NCT00000556|Drug|verapamil|
16393149|NCT00000556|Drug|diltiazem|
16393150|NCT00000556|Drug|digoxin|
16393151|NCT00000556|Procedure|catheter ablation|
16393152|NCT00000556|Device|pacemaker, artificial|
16393153|NCT00000555|Drug|estrogen replacement therapy|
16393154|NCT00000555|Drug|estrogens, conjugated|
16393155|NCT00000555|Drug|progesterone|
16393156|NCT00000555|Drug|hormone replacement therapy|
16393157|NCT00000555|Drug|supplementation, food|
16393158|NCT00000555|Drug|ascorbic acid|
16393159|NCT00000555|Drug|vitamin e|
16393160|NCT00000554|Procedure|Angiography, MRI, Dobutamine-Stress Echocardiography, PET,|
16393161|NCT00000554|Procedure|Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing|
16393162|NCT00000553|Drug|simvastatin|
16393163|NCT00000553|Drug|niacin|
16393164|NCT00000553|Drug|antioxidants|
16393165|NCT00000552|Procedure|angioplasty, transluminal, percutaneous coronary|
16393166|NCT00000552|Procedure|coronary artery bypass|
16393167|NCT00000552|Drug|thrombolytic therapy|
16393168|NCT00000551|Behavioral|health education|
16393169|NCT00000550|Behavioral|health education|
16393170|NCT00000549|Drug|estrogen replacement therapy|
16393171|NCT00000549|Drug|hormone replacement therapy|
16393172|NCT00000549|Drug|estrogens|
16393173|NCT00000549|Drug|progestins|
16393174|NCT00000548|Procedure|mechanical ventilation|
16393175|NCT00000547|Drug|enalapril|
16393176|NCT00000546|Behavioral|meditation|
16393177|NCT00000545|Behavioral|exercise|
16393178|NCT00000545|Behavioral|diet|
16393179|NCT00000544|Behavioral|diet therapy|
16393180|NCT00000543|Behavioral|dietary supplements|
16393181|NCT00000543|Drug|calcium|
16393182|NCT00000542|Drug|Inhibitors, ACE|
16393183|NCT00000542|Drug|amlodipine|
16393184|NCT00000542|Drug|lisinopril|
16393185|NCT00000542|Drug|doxazosin|
16393186|NCT00000542|Drug|chlorthalidone|
16393187|NCT00000542|Drug|pravastatin|
16393188|NCT00000542|Behavioral|diet, fat-restricted|
16393189|NCT00000541|Behavioral|dietary supplements|
16393190|NCT00000541|Drug|vitamin C|
16393191|NCT00000541|Drug|vitamin E|
16393192|NCT00000541|Drug|beta-carotene|
16393193|NCT00000541|Drug|folic acid/Vitamin B6/Vitamin B12|
16393194|NCT00000540|Device|defibrillators, implantable|
16393195|NCT00000539|Drug|niacin|
16393196|NCT00000539|Drug|pravastatin|
16393197|NCT00000539|Drug|beta-carotene|
16393198|NCT00000539|Drug|vitamin E|
16393199|NCT00000539|Behavioral|dietary supplements|
16393200|NCT00000539|Drug|vitamin C|
16393201|NCT00000539|Drug|warfarin|
16393202|NCT00000538|Behavioral|diet, fat-restricted|
16393203|NCT00000537|Behavioral|meditation|
16393204|NCT00000537|Behavioral|relaxation|
16393205|NCT00000536|Behavioral|sodium, dietary|
16393206|NCT00000535|Behavioral|diet, reducing|
16393207|NCT00000535|Behavioral|diet, sodium-restricted|
16393208|NCT00000534|Drug|calcium|
16393209|NCT00000534|Behavioral|dietary supplements|
16393210|NCT00000533|Behavioral|social support|
16393211|NCT00000532|Behavioral|diet, fat-restricted|
16393212|NCT00000531|Device|defibrillators, implantable|
16393213|NCT00000531|Drug|amiodarone amiodarone|
16393214|NCT00000531|Drug|sotalol|
16393215|NCT00000530|Drug|nifedipine|
16393216|NCT00000530|Behavioral|biofeedback (psychology)|
16393217|NCT00000530|Procedure|electromyography|
16393218|NCT00000529|Drug|tamoxifen|
16393219|NCT00000528|Behavioral|diet, sodium-restricted (Phase III) diet, sodium-restricted|
16393220|NCT00000528|Behavioral|diet, reducing (Phase III)|
16393221|NCT00000527|Drug|aspirin|
16393222|NCT00000527|Drug|dipyridamole|
16393223|NCT00000526|Drug|encainide|
16393224|NCT00000526|Drug|flecainide|
16393225|NCT00000526|Drug|moricizine|
16393226|NCT00000525|Drug|hydrochlorothiazide|
16393227|NCT00000525|Behavioral|diet, potassium supplementation|
16393228|NCT00000525|Behavioral|diet, magnesium supplementation|
16393229|NCT00000525|Drug|triamterene|
16393230|NCT00000525|Drug|chlorthalidone|
16393231|NCT00000524|Drug|cyclosporine|
16393232|NCT00000524|Drug|prednisone|
16393233|NCT00000523|Behavioral|exercise|
16393234|NCT00000522|Behavioral|diet, sodium-restricted|
16393235|NCT00000522|Behavioral|diet, reducing|
16393236|NCT00000522|Behavioral|exercise|
16393237|NCT00000522|Behavioral|alcohol restriction|
16393238|NCT00000522|Drug|chlorthalidone|
16393239|NCT00000522|Drug|acebutolol|
16393240|NCT00000522|Drug|doxazosin|
16393241|NCT00000522|Drug|amlodipine|
16393242|NCT00000522|Drug|enalapril|
16393243|NCT00000521|Behavioral|diet, sodium-restricted|
16393244|NCT00000521|Behavioral|diet, potassium-supplemented|
16393245|NCT00000520|Drug|immunoglobulins, intravenous|
16393246|NCT00000520|Drug|aspirin|
16393247|NCT00000519|Behavioral|diet, reducing|
16393248|NCT00000519|Behavioral|exercise|
16393249|NCT00000519|Behavioral|diet, fat-restricted|
16393250|NCT00000518|Procedure|electrophysiology|
16393251|NCT00000518|Procedure|electrocardiography, ambulatory|
16393252|NCT00000518|Drug|imipramine|
16393253|NCT00000518|Drug|mexiletine|
16393254|NCT00000518|Drug|procainamide|
16393255|NCT00000518|Drug|quinidine|
16393256|NCT00000518|Drug|sotalol|
16393257|NCT00000517|Drug|warfarin|
16393258|NCT00000516|Drug|enalapril|
16393259|NCT00000515|Behavioral|diet, reducing|
16393260|NCT00000514|Drug|chlorthalidone|
16393261|NCT00000514|Drug|atenolol|
16393262|NCT00000514|Drug|reserpine|
16393263|NCT00000513|Behavioral|diet, reducing|
16393264|NCT00000513|Behavioral|diet, sodium-restricted|
16393265|NCT00000513|Drug|chlorthalidone|
16393266|NCT00000513|Drug|atenolol|
16393267|NCT00000512|Drug|lovastatin|Lovastatin was begun at a dose of 20 mg twice a day (in the morning and at bedtime). If the LDL cholesterol level did not fall below 3.1 mmol per liter after three months, the dose of lovastatin was increased to 40 mg twice a day.
16393268|NCT00000512|Drug|colestipol|Colestipol was begun at a dose of 5 g three times a day with meals and increased to 10 g three times a day after 10 days, unless side effects delayed the increase. Psyllium hydrophic mucilloid (Metamucil) was provided if dietary bran was insufficient to control constipation.
16393269|NCT00000512|Drug|niacin|Niacin was started at 125 mg twice a day and gradually increased to 500 mg four times a day (with meals and at bedtime) at one month and 1 g four times a day at two months. If the LDL cholesterol level did not fall below 3.1 mmol per liter (120 mg per deciliter) after three months, the dose of niacin was increased to 1.5 g (three tablets) four times a day, but no further.
16393270|NCT00000512|Other|Placebo for colestipol|Placebo for colestipol.
16393271|NCT00000512|Other|Placebo for lovastatin|Placebo for lovastatin
16393272|NCT00000511|Dietary Supplement|mineral supplements|
16393273|NCT00000511|Dietary Supplement|Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements|
16393274|NCT00000511|Behavioral|dietary supplements|
16393275|NCT00000510|Drug|aspirin|
16393276|NCT00000510|Drug|dipyridamole|
16393277|NCT00000510|Procedure|angioplasty, transluminal, percutaneous coronary|
16393278|NCT00000509|Behavioral|diet, sodium-restricted|
16393279|NCT00000509|Behavioral|diet, potassium-supplementation|
16393280|NCT00000508|Behavioral|smoking cessation|
16393281|NCT00000508|Behavioral|diet, reducing|
16393282|NCT00000508|Behavioral|exercise|
16393283|NCT00000508|Behavioral|diet, fat-restricted|
16393284|NCT00000507|Drug|streptokinase|
16393285|NCT00000506|Drug|fenfluramine|
16393286|NCT00000506|Drug|phentermine|
16393287|NCT00000505|Drug|tissue plasminogen activator|
16393288|NCT00000505|Procedure|angioplasty, transluminal, percutaneous coronary|
16393289|NCT00000504|Drug|encainide|
16393290|NCT00000504|Drug|moricizine|
16393291|NCT00000504|Drug|flecainide|
16393292|NCT00000504|Drug|imipramine|
16393293|NCT00000503|Drug|nitroglycerin|
16393294|NCT00000503|Drug|streptokinase|
16393295|NCT00000503|Procedure|heart catheterization|
16393296|NCT00000502|Procedure|cardiopulmonary resuscitation|
16393297|NCT00000501|Behavioral|diet, sodium-restricted|
16393298|NCT00000501|Behavioral|diet, reducing|
16393299|NCT00000501|Drug|potassium|
16393300|NCT00000500|Drug|aspirin|
16393301|NCT00000500|Drug|carotene|
16393302|NCT00000499|Drug|chlorthalidone|
16393303|NCT00000499|Drug|reserpine|
16393304|NCT00000499|Drug|hydralazine|
16393305|NCT00000499|Drug|metoprolol|
16393306|NCT00000498|Behavioral|diet, sodium-restricted|
16393307|NCT00000498|Behavioral|diet, reducing|
16393308|NCT00000498|Behavioral|alcohol restriction|
16393309|NCT00000498|Drug|antihypertensive agents|
16393310|NCT00000497|Behavioral|diet, sodium-restricted|
16393311|NCT00000497|Behavioral|diet, reducing|
16393312|NCT00000496|Drug|aspirin|
16393313|NCT00000496|Drug|dipyridamole|
16393314|NCT00000495|Behavioral|diet, reducing|
16393315|NCT00000495|Behavioral|diet, sodium-restricted|
16393316|NCT00000495|Behavioral|alcohol restriction|
16393317|NCT00000495|Behavioral|exercise|
16393318|NCT00000494|Drug|indomethacin|
16393319|NCT00000494|Procedure|surgery, cardiovascular|
16393320|NCT00000493|Drug|propranolol|
16393321|NCT00000493|Drug|hyaluronidase|
16393322|NCT00000492|Drug|propranolol|
16393323|NCT00000491|Drug|aspirin|
16393324|NCT00000490|Procedure|jejunoileal bypass|
16393325|NCT00000490|Behavioral|diet, fat-restricted|
16393326|NCT00000489|Procedure|coronary artery bypass|
16393327|NCT00000488|Drug|cholestyramine|
16393328|NCT00000488|Behavioral|diet, fat-restricted|
16393329|NCT00000487|Drug|antihypertensive agents|
16393330|NCT00000487|Behavioral|smoking cessation|
16393331|NCT00000487|Behavioral|diet, fat-restricted|
16393332|NCT00000487|Drug|diuretics|
16393333|NCT00000486|Procedure|coronary artery bypass|
16393334|NCT00000485|Drug|diuretics|
16393335|NCT00000485|Drug|antihypertensive agents|
16393336|NCT00000484|Drug|chlorothiazide|
16393337|NCT00000484|Drug|Rauwolfia alkaloids|
16393338|NCT00000483|Drug|estrogen|
16393339|NCT00000483|Drug|clofibrate|
16393340|NCT00000483|Drug|dextrothyroxine sodium|
16393341|NCT00000483|Drug|niacin|
16393342|NCT00000482|Drug|estrogen|
16393343|NCT00000482|Drug|clofibrate clofibrate|
16393344|NCT00000482|Drug|dextrothyroxine sodium|
16393345|NCT00000482|Drug|niacin|
16393346|NCT00000481|Behavioral|diet, fat-restricted|
16393347|NCT00000480|Procedure|electrophysiology|
16393348|NCT00000480|Drug|anti-arrhythmia agents|
16393349|NCT00000480|Device|defibrillators, implantable|
16393350|NCT00000479|Drug|Aspirin|Participants will receive 100 mg of aspirin every other day.
16393351|NCT00000479|Drug|Vitamin E|Participants will receive 600 IU of vitamin E every other day.
16393352|NCT00000479|Behavioral|Placebo|Participants will receive placebo.
16393353|NCT00000478|Drug|atenolol|
16393354|NCT00000478|Drug|nifedipine|
16393355|NCT00000478|Drug|diltiazem|
16393356|NCT00000478|Drug|isosorbide dinitrate|
16393357|NCT00000478|Procedure|coronary artery bypass coronary artery bypass|
16393358|NCT00000478|Procedure|angioplasty, transluminal, percutaneous coronary|
16393359|NCT00000477|Drug|lovastatin|
16393360|NCT00000476|Drug|digitalis|
16393361|NCT00000475|Behavioral|health education|
16393362|NCT00000474|Behavioral|behavior therapy|
16393363|NCT00000473|Behavioral|dietary supplements|
16393364|NCT00000473|Drug|fatty acids, omega-3|
16393365|NCT00000473|Behavioral|diet, fat-restricted|
16393366|NCT00000472|Drug|tissue plasminogen activator|
16393367|NCT00000472|Drug|heparin|
16393368|NCT00000471|Behavioral|diet, vegetarianism|
16393369|NCT00000471|Behavioral|diet, fat-restricted|
16393370|NCT00000471|Behavioral|exercise|
16393371|NCT00000471|Behavioral|smoking cessation|
16393372|NCT00000470|Procedure|cardiac surgical procedures|
16393373|NCT00000470|Procedure|cardiopulmonary bypass|
16393374|NCT00000469|Drug|aspirin|
16393375|NCT00000469|Drug|lovastatin|
16393376|NCT00000468|Drug|tissue plasminogen activator|
16393377|NCT00000467|Behavioral|diet|
16393378|NCT00000467|Behavioral|exercise|
16393379|NCT00000467|Behavioral|smoking cessation|
16393380|NCT00000466|Drug|estrogens, conjugated|
16393381|NCT00000466|Drug|medroxyprogesterone|
16393382|NCT00000466|Drug|progesterone|
16393383|NCT00000466|Drug|estrogen replacement therapy|
16393384|NCT00000465|Procedure|angioplasty, transluminal, percutaneous coronary|
16393385|NCT00000465|Procedure|coronary artery bypass|
16393386|NCT00000464|Drug|amiodarone|
16393387|NCT00000464|Drug|imipramine|
16393388|NCT00000464|Drug|mexiletine|
16393389|NCT00000464|Drug|procainamide|
16393390|NCT00000464|Drug|propafenone|
16393391|NCT00000464|Drug|quinidine|
16393392|NCT00000464|Drug|sotalol|
16393393|NCT00000463|Drug|lovastatin|
16393394|NCT00000463|Drug|cholestyramine|
16393395|NCT00000463|Drug|warfarin|
16393396|NCT00000462|Procedure|angioplasty, transluminal, percutaneous coronary|
16393397|NCT00000462|Procedure|coronary artery bypass|
16393398|NCT00000461|Drug|pravastatin|
16393399|NCT00000461|Drug|niacin|
16393400|NCT00000461|Drug|cholestyramine|
16393401|NCT00000461|Drug|gemfibrozil|
16393402|NCT00000461|Drug|fatty acids, omega-3|
16393403|NCT00000460|Behavioral|Low intensity exercise|
16393404|NCT00000460|Behavioral|High intensity exercise|
16393405|NCT00000459|Behavioral|diet, fat-restricted|
16393406|NCT00004500|Drug|Lucinactant|Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.
16393407|NCT00004500|Other|Standard Care|The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC
16393408|NCT00004498|Genetic|Adenoviral Vector-Mediated Gene Transfer|
16393409|NCT00004497|Drug|UT-15|
16393410|NCT00004496|Drug|alpha-melanocyte stimulating hormone|
16393411|NCT00004495|Drug|cyanocobalamin|
16393412|NCT00004495|Drug|folic acid|
16393413|NCT00004495|Drug|pyridoxine|
16393414|NCT00004494|Drug|vasoactive intestinal peptide|
16393415|NCT00004493|Drug|sodium dichloroacetate|
16393416|NCT00004492|Drug|clotrimazole|
16393417|NCT00004492|Drug|hydroxyurea|
16393418|NCT00004490|Drug|sodium dichloroacetate|
16393419|NCT00004489|Drug|alendronate sodium|
16393420|NCT00004489|Drug|calcium carbonate|
16393421|NCT00004489|Drug|cholecalciferol|
16393422|NCT00004488|Drug|alendronate sodium|
16393423|NCT00004488|Drug|calcium carbonate|
16393424|NCT00004488|Drug|cholecalciferol|
16393425|NCT00004487|Drug|chondrocyte-alginate gel suspension|
16393426|NCT00004486|Drug|fluoxetine|
16393427|NCT00004485|Drug|cyclosporine|
16393428|NCT00004485|Drug|fludarabine|
16393429|NCT00004485|Drug|mycophenolate mofetil|
16393430|NCT00004485|Procedure|Bone Marrow Transplantation|
16393431|NCT00004482|Drug|Cyclosporine|
16393432|NCT00004482|Drug|methylprednisolone|
16393433|NCT00004482|Drug|Muromonab-CD3|
16393434|NCT00004482|Drug|prednisone|
16393435|NCT00004481|Procedure|genetic testing|
16393436|NCT00004480|Drug|botulinum toxin type A|
16393437|NCT00004479|Drug|midodrine|
16393438|NCT00004478|Drug|droxidopa|
16393439|NCT00004474|Drug|Anti-thymocyte globulin|Given via IV over 4 hours
16393440|NCT00004474|Drug|Cyclophosphamide|Given via IV over 60 minutes on Days -5 to -2
16393441|NCT00004474|Procedure|Bone marrow transplantation|Given on Day 0
16393442|NCT00004471|Genetic|pGT-1 gene lipid complex|
16393443|NCT00004468|Drug|calcitriol|
16393444|NCT00004467|Drug|N-acetylcysteine (NAC)|Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.
16393445|NCT00004467|Drug|Placebo|Infusion of 5% dextrose
16393446|NCT00004466|Drug|Atorvastatin|
16393447|NCT00004466|Drug|Placebo|
16393448|NCT00004465|Drug|SYNSORB Pk|
16393449|NCT00004465|Drug|Placebo|
16393450|NCT00004464|Drug|cyclophosphamide|
16393451|NCT00004464|Drug|filgrastim|
16393452|NCT00004454|Genetic|lymphocyte gene therapy|
16393453|NCT00004451|Drug|Glucose|
16393454|NCT00004450|Drug|glyceryl trierucate|
16393455|NCT00004450|Drug|glyceryl trioleate|
16393456|NCT00004450|Drug|interferon beta|
16393457|NCT00004450|Drug|thalidomide|
16393458|NCT00004449|Behavioral|intensive one-on-one behavioral treatment|Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
16393459|NCT00004449|Behavioral|Individualized in home parent training|Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
16393460|NCT00004448|Drug|omega-3 fatty acids|
16393461|NCT00004448|Drug|prednisone|
16393462|NCT00004446|Drug|fluoxetine|
16393463|NCT00004445|Procedure|Surgery|
16393464|NCT00004445|Device|IRS-8|
16393465|NCT00004444|Drug|paromomycin|
16393466|NCT00004444|Drug|streptomycin|
16393467|NCT00004443|Drug|NTBC|
16393468|NCT00004442|Drug|chenodeoxycholic acid|
16393469|NCT00004442|Drug|cholic acid|
16393470|NCT00004442|Drug|ursodiol|
16393471|NCT00004441|Drug|tauroursodeoxycholic acid|
16393472|NCT00004441|Drug|ursodiol|
16393473|NCT00004440|Drug|ibuprofen|
16393474|NCT00004438|Drug|leuprolide|
16393475|NCT00004437|Device|Multichannel Auditory Brain Stem Implant|
16393476|NCT00004436|Drug|leuprolide|
16393477|NCT00004436|Drug|prednisone|
16393478|NCT00004433|Drug|pergolide|
16393479|NCT00004431|Drug|L-baclofen|
16393480|NCT00004430|Drug|Dihematoporphyrin derivative|
16393481|NCT00004430|Drug|prednisolone|
16393482|NCT00004430|Procedure|Laser surgery|
16393483|NCT00004429|Drug|growth hormone|
16393484|NCT00004428|Drug|CPX|
16393485|NCT00004426|Drug|gonadotropin releasing hormone|
16393486|NCT00004426|Drug|leuprolide|
16393487|NCT00004424|Drug|fentanyl|
16393488|NCT00004424|Drug|Midazolam|
16393489|NCT00004424|Drug|propofol|
16393490|NCT00004423|Drug|-aminosalicylic acid|
16393491|NCT00004422|Drug|immune globulin|
16393492|NCT00004421|Device|implanted pulse generator|
16393493|NCT00004420|Drug|gamma-Linolenic acid|
16393494|NCT00004419|Drug|insulin-like growth factor I|
16393495|NCT00004418|Drug|glyceryl trierucate/glyceryl trioleate|Administration of glyceryl trierucate/glyceryl trioleate
16393496|NCT00004416|Drug|botulinum toxin type A|
16393497|NCT00004415|Device|Medlink spinal cord electrode|
16393498|NCT00004414|Drug|sincalide|
16393499|NCT00004412|Drug|Arginine Butyrate|To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.
16393500|NCT00004412|Other|Standard local care dressing|To heal leg ulcers.
16393501|NCT00004410|Drug|tauroursodeoxycholic acid|
16393502|NCT00004409|Drug|collagenase|
16393503|NCT00004408|Drug|poloxamer 188|
16393504|NCT00004407|Drug|immune globulin|
16393505|NCT00004406|Drug|human parathyroid hormone|
16393506|NCT00004404|Drug|clotrimazole|
16393507|NCT00004404|Drug|hydroxyurea|
16393508|NCT00004403|Drug|albendazole|
16393509|NCT00004403|Drug|dexamethasone|
16393510|NCT00004403|Drug|phenytoin|
16393511|NCT00004402|Drug|calcitriol|
16393512|NCT00004402|Drug|interferon gamma|
16393513|NCT00004401|Drug|botulism immune globulin|
16393514|NCT00004400|Drug|testosterone|
16393515|NCT00004399|Drug|magnesium sulfate|
16393516|NCT00004399|Drug|nimodipine|
16393517|NCT00004398|Drug|heme arginate|
16393518|NCT00004398|Drug|tin mesoporphyrin|
16393519|NCT00004397|Drug|heme arginate|
16393520|NCT00004397|Drug|tin mesoporphyrin|
16393521|NCT00004396|Drug|heme arginate|
16393522|NCT00004396|Drug|tin mesoporphyrin|
16393523|NCT00004393|Drug|risperidone|
16393524|NCT00004390|Drug|desipramine|
16393525|NCT00004390|Drug|methadone|
16393526|NCT00004390|Drug|morphine|
16393527|NCT00004390|Drug|nortriptyline|
16393528|NCT00004387|Procedure|fetal nigral transplantation|
16393529|NCT00004386|Genetic|recombinant adenovirus containing the ornithine transcarbamylase gene|
16393530|NCT00004382|Drug|tin mesoporphyrin|
16393531|NCT00004382|Procedure|Phototherapy|
16393532|NCT00004381|Drug|tin mesoporphyrin|
16393533|NCT00004380|Drug|relaxin|
16393534|NCT00004378|Procedure|Stem Cell Transplantation|
16393535|NCT00004376|Drug|guanfacine|
16393536|NCT00004375|Procedure|ultraviolet A-1 light treatment|
16393537|NCT00004373|Drug|alprazolam|
16393538|NCT00004368|Drug|colchicine|
16393539|NCT00004367|Procedure|Clinical vestibular tests|
16393540|NCT00004366|Procedure|Physical therapy|
16393541|NCT00004364|Drug|desmopressin|
16393542|NCT00004363|Drug|chlorpropamide|
16393543|NCT00004363|Drug|desmopressin|
16393544|NCT00004361|Drug|calcium gluconate|
16393545|NCT00004361|Drug|sodium citrate|
16393546|NCT00004360|Drug|chlorothiazide|
16393547|NCT00004359|Drug|methoxsalen|
16393548|NCT00004358|Drug|calcitonin|
16393549|NCT00004357|Drug|Methylprednisolone|IV
16393550|NCT00004357|Drug|Prednisolone|Oral
16393551|NCT00004347|Behavioral|diet|
16393552|NCT00004346|Drug|chenodeoxycholic acid|
16393553|NCT00004346|Drug|lovastatin|
16393554|NCT00004344|Drug|leuprolide|
16393555|NCT00004344|Drug|testosterone|
16393556|NCT00004340|Drug|calcitriol|
16393557|NCT00004340|Drug|growth hormone|
16393558|NCT00004339|Drug|tetrathiomolybdate|
16393559|NCT00004339|Drug|trientine|
16393560|NCT00004338|Drug|zinc acetate|
16393561|NCT00004333|Drug|NTBC|
16393562|NCT00004330|Drug|luteinizing hormone-releasing factor|
16393563|NCT00004328|Drug|enalapril|
16393564|NCT00004328|Drug|polystyrene sulfonate|
16393565|NCT00004327|Drug|octreotide|
16393566|NCT00004323|Drug|anti-thymocyte globulin|
16393567|NCT00004323|Drug|cyclophosphamide|
16393568|NCT00004323|Drug|cyclosporine|
16393569|NCT00004323|Drug|mesna|
16393570|NCT00004323|Drug|methotrexate|
16393571|NCT00004323|Drug|methylprednisolone|
16393572|NCT00004317|Drug|Leucovorin calcium|See arm descriptions
16393573|NCT00004317|Drug|Pyrimethamine|See arm descriptions
16393574|NCT00004317|Drug|Spiramycin|Spiramycin is administered before the fetal diagnosis is made.
16393575|NCT00004317|Drug|Sulfadiazine|See arm descriptions
16393576|NCT00004316|Drug|capsaicin|
16393577|NCT00004315|Drug|ursodiol|
16393578|NCT00004314|Drug|aminomidazole carboxamide riboside|
16393579|NCT00004313|Drug|dehydroepiandrosterone|
16393580|NCT00004311|Drug|leuprolide acetate|
16393581|NCT00004311|Drug|spironolactone|
16393582|NCT00004310|Drug|Clomipramine|
16393583|NCT00004307|Behavioral|Protein and calorie controlled diet|
16393584|NCT00004307|Genetic|Ornithine transcarbamylase vector|
16393585|NCT00004300|Drug|bromocriptine|
16393586|NCT00004300|Drug|sertraline hydrochloride|
16393587|NCT00004297|Drug|diazepam|
16393588|NCT00004297|Drug|lorazepam|
16393589|NCT00004294|Genetic|human glucocerebrosidase gene into autologous peripheral blood stem cells|
16393590|NCT00004293|Drug|glucocerebrosidase|
16393591|NCT00004288|Drug|olsalazine|
16393592|NCT00004287|Genetic|H5.001CBCFTR|
16393593|NCT00004286|Drug|immune globulin|
16393594|NCT00004285|Device|Standard dose, low flux hemodialysis|
16393595|NCT00004285|Device|Standard dose, high flux hemodialysis|
16393596|NCT00004285|Device|High dose, low flux hemodialysis|
16393597|NCT00004285|Device|High dose, high flux hemodialysis|
16393598|NCT00004284|Drug|potassium citrate|
16393599|NCT00004284|Drug|potassium phosphate|
16393600|NCT00004278|Drug|ganciclovir|
16393601|NCT00004276|Drug|thalidomide|
16393602|NCT00004275|Drug|growth hormone|
16393603|NCT00004275|Drug|oxandrolone|
16393604|NCT00004274|Drug|Estrogen|
16393605|NCT00004268|Drug|midodrine|
16393606|NCT00004266|Drug|Lisinopril|
16393607|NCT00004266|Drug|Nifedipine|
16393608|NCT00004266|Drug|Simvastatin|
16393609|NCT00000170|Drug|Atropine|Atropine
16393610|NCT00000170|Device|Eye Patch|Patching
16393611|NCT00000167|Procedure|Low-Intensity Laser Treatment|Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.
16393612|NCT00000162|Procedure|Macular Argon Laser Photocoagulation|
16393613|NCT00000162|Procedure|Peripheral Scatter Argon Laser Photocoagulation|
16393614|NCT00000162|Procedure|Scatter Argon Laser Photocoagulation|
16393615|NCT00000161|Drug|Aspirin|
16393616|NCT00000161|Drug|Beta-Carotene|
16393617|NCT00000161|Drug|Vitamin C|
16393618|NCT00000161|Drug|Vitamin E|
16393619|NCT00000160|Procedure|Xenon Photocoagulation|
16393620|NCT00000160|Procedure|Argon Photocoagulation|
16393621|NCT00000160|Procedure|Photocoagulation|
16393622|NCT00000159|Drug|Sorbinil|
16393623|NCT00000158|Procedure|Argon Blue-Green Laser Photocoagulation|
16393624|NCT00000157|Drug|Aspirin|
16393625|NCT00000156|Device|Goggles|
16393626|NCT00000156|Procedure|Ambient Light Reduction|
16393627|NCT00000154|Procedure|Vitrectomy|
16393628|NCT00000153|Procedure|Blue-Green Argon Laser Treatment|
16393629|NCT00000153|Procedure|Red Krypton Laser Treatment|
16393630|NCT00000152|Drug|Aspirin|
16393631|NCT00000152|Drug|Beta-Carotene|
16393632|NCT00000151|Drug|Aspirin|
16393633|NCT00000151|Procedure|Argon Laser Photocoagulation|
16393634|NCT00000150|Procedure|Subfoveal Choroidal Neovascularization Removal|
16393635|NCT00000149|Drug|Beta Blocker|
16393636|NCT00000149|Procedure|Trabeculectomy|
16393637|NCT00000149|Procedure|Argon Laser Trabeculoplasty|
16393638|NCT00000148|Procedure|Argon Laser Trabeculoplasty|
16393639|NCT00000148|Procedure|Trabeculectomy|
16393640|NCT00000147|Drug|Methylprednisolone|
16393641|NCT00000147|Drug|Prednisone|
16393642|NCT00000146|Drug|Methylprednisolone|
16393643|NCT00000146|Drug|Prednisone|
16393644|NCT00000145|Dietary Supplement|Antioxidants|500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
16393645|NCT00000145|Dietary Supplement|Zinc|80 milligrams zinc oxide; 2 milligrams of cupric oxide
16393646|NCT00000145|Dietary Supplement|Antioxidants and zinc|500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
16393647|NCT00000144|Procedure|Argon Laser Treatment|
16393648|NCT00000143|Device|Ganciclovir implant and oral ganciclovir|oral ganciclovir, 1 gm three times daily
16393649|NCT00000143|Drug|Cidofovir intravenous|intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
16393650|NCT00000142|Drug|Cidofovir|"Three groups:
~the deferral group, treatment deferred until retinitis progressed
~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
16393651|NCT00000140|Drug|Perfluoropropane|
16393652|NCT00000140|Drug|Sulfur Hexafluoride|
16393653|NCT00000140|Drug|Silicone Oil|
16393654|NCT00000139|Behavioral|Stress|
16393655|NCT00000139|Drug|Acyclovir|
16393656|NCT00000138|Drug|Prednisolone Phosphate|
16393657|NCT00000138|Drug|Acyclovir|
16393658|NCT00000137|Procedure|Histocompatibility Matching|
16393659|NCT00000136|Drug|Foscarnet|60 mg/kg every 8 hours, 90 mg/kg/day
16393660|NCT00000136|Drug|Ganciclovir|5 mg/kg every 12 hours, 5 mg/kg every 24 hours
16393661|NCT00000135|Drug|MSL-109|60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
16393662|NCT00000135|Other|Placebo|60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
16393663|NCT00000134|Drug|Ganciclovir|intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
16393664|NCT00000134|Drug|Foscarnet|intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
16393665|NCT00000133|Procedure|Trans-scleral Cryotherapy|
16393666|NCT00000132|Drug|Betaxolol|
16393667|NCT00000132|Procedure|Argon Laser Trabeculoplasty|
16393668|NCT00000131|Procedure|Photocoagulation Therapy|
16393669|NCT00000130|Drug|Intravitreal Antibiotics|
16393670|NCT00000130|Procedure|Initial Pars Plana Vitrectomy|
16393671|NCT00000129|Procedure|Radial Keratotomy|
16393672|NCT00000128|Device|Bifocal Spectacle Lenses|
16393673|NCT00000127|Procedure|Optic Nerve Sheath Decompression Surgery|
16393674|NCT00000126|Procedure|Surgery|
16393675|NCT00000125|Drug|Topical ocular hypotensive eye drops.|Topical ocular hypotensive eye drops.
16393676|NCT00000124|Procedure|Brachytherapy|
16393677|NCT00000124|Procedure|Eye Removal|
16393678|NCT00000123|Device|Polymethyl Methacrylate-Silicone Contact Lenses|
16393679|NCT00000123|Device|Polymethyl Methacrylate Contact Lenses|
16393680|NCT00000122|Drug|5-Fluorouracil|
16393681|NCT00000121|Device|Prisms in Eyeglasses|
16393682|NCT00000120|Drug|Erythromycin Ointment|
16393683|NCT00000120|Drug|Silver Nitrate Drops|
16393684|NCT00000119|Device|Heparin Surface-Modified Intraocular Lens|
16393685|NCT00000118|Device|Sustained-Release Intraocular Drug Delivery System|
16393686|NCT00000117|Drug|Immunoglobulin|
16393687|NCT00000116|Drug|Vitamin A|
16393688|NCT00000116|Drug|Nutritional Supplement|
16393689|NCT00000115|Drug|Acetazolamide|
16393690|NCT00000114|Drug|Vitamin E|
16393691|NCT00000114|Drug|Vitamin A|
16393692|NCT00000113|Other|Progressive Addition Lenses|Varilux comfort with +2.00 addition
16393693|NCT00000113|Other|single vision lenses|
16393694|NCT00000358|Drug|Lofexidine|
16393695|NCT00000357|Drug|Buprenorphine|
16393696|NCT00000356|Drug|LAAM|
16393697|NCT00000355|Drug|Buprenorphine|
16393698|NCT00000354|Drug|Lofexidine|
16393699|NCT00000353|Drug|Buprenorphine/naloxone|
16393700|NCT00000352|Drug|Dextromethorphan|
16393701|NCT00000350|Procedure|radioactive substance|
16393702|NCT00000349|Drug|Flupenthixol|
16393703|NCT00000348|Drug|Dihydrexidine|
16393704|NCT00000347|Drug|Risperidone|
16393705|NCT00000346|Behavioral|counseling|
16393706|NCT00000345|Drug|Lofexidine|
16393707|NCT00000344|Drug|Buprenorphine/naloxone|
16393708|NCT00000343|Behavioral|counseling|
16393709|NCT00000342|Drug|Risperidone|
16393710|NCT00000341|Drug|Buprenorphine|
16393711|NCT00000340|Drug|Pemoline|
16393712|NCT00000339|Drug|Risperidone|
16393713|NCT00000338|Drug|Lisuride|
16393714|NCT00000337|Drug|Selegiline|
16393715|NCT00000336|Drug|Selegiline|
16393716|NCT00000335|Drug|Morphine|
16393717|NCT00000334|Drug|Buprenorphine|
16393718|NCT00000333|Drug|Benztropine|
16393719|NCT00000332|Drug|Nimodipine|
16393720|NCT00000331|Drug|Test Drug|
16393721|NCT00000331|Drug|Placebo Drug|
16393722|NCT00000330|Drug|Opioid-Related Disorders|
16393723|NCT00000329|Drug|Opioid-Related Disorders|
16393724|NCT00000328|Drug|Opioid-Related Disorders|
16393725|NCT00000327|Drug|Heroin Dependence|
16393726|NCT00000326|Drug|Heroin Dependence|
16393727|NCT00000325|Behavioral|Gonadorelin|
16393728|NCT00000324|Drug|Tryptophan|
16393729|NCT00000322|Behavioral|Tyrosine|
16393730|NCT00000321|Drug|Desipramine|
16393731|NCT00000320|Drug|Buprenorphine formulation: liquid vs. tablet|random assignment to liquid buprenorphine or tablet buprenorphine
16393732|NCT00000319|Drug|Buprenorphine|
16393733|NCT00000318|Drug|Buprenorphine|"Experimental Maintenance treatment with daily medication
~Experimental Maintenance treatment with thrice-weekly medication"
16393734|NCT00000317|Drug|Risperidone|Risperidone (4mg/day)
16393735|NCT00000317|Drug|Placebo|Placebo
16393736|NCT00000317|Behavioral|Relapse prevention counseling|Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
16393737|NCT00000316|Drug|Cocaine|
16393738|NCT00000315|Drug|Cocaine|
16393739|NCT00000314|Drug|M-CPP|
16393740|NCT00000313|Drug|Fenfluramine|
16393741|NCT00000312|Drug|M-CPP|
16393742|NCT00000311|Drug|Buprenorphine|Medication and Behavioral
16393743|NCT00000311|Drug|methadone|medication and behavioral
16393744|NCT00000310|Drug|Risperidone|
16393745|NCT00000309|Drug|Risperidone|
16393746|NCT00000308|Drug|Dextroamphetamine|15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
16393747|NCT00000308|Drug|D-amphetamine|15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
16393748|NCT00000308|Drug|placebo|placebo
16393749|NCT00000307|Drug|Naltrexone|
16393750|NCT00000306|Drug|Dextroamphetamine|
16393751|NCT00000305|Drug|Dextroamphetamine|
16393752|NCT00000304|Drug|Dextroamphetamine|15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
16393753|NCT00000304|Drug|D-Amphetamine|30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
16393754|NCT00000304|Drug|Placebo|Placebo
16393755|NCT00000303|Drug|Baclofen|
16393756|NCT00000302|Drug|Buprenorphine|
16393757|NCT00000301|Drug|Amantadine|
16393758|NCT00000300|Drug|LAAM|
16393759|NCT00000299|Drug|Buprenorphine|
16393760|NCT00000298|Drug|Buprenorphine/naloxone|
16393761|NCT00000297|Drug|Labetalol|
16393762|NCT00000296|Drug|Cotinine fumarate|
16393763|NCT00000295|Drug|Micronized Progesterone|
16393764|NCT00000294|Drug|Carvedilol|
16393765|NCT00000293|Drug|Nefazodone|
16393766|NCT00000292|Procedure|Cocaine|
16393767|NCT00000291|Drug|Labetalol|
16393768|NCT00000290|Drug|Cocaine|
16393769|NCT00000289|Drug|Ondansetron|
16393770|NCT00000288|Drug|Cotinine fumarate|
16393771|NCT00000286|Drug|Nefazodone|
16393772|NCT00000285|Drug|Phenytoin|
16393773|NCT00000284|Drug|Cotinine fumarate|
16393774|NCT00000282|Drug|Pemoline|
16393775|NCT00000281|Behavioral|Amantadine|
16393776|NCT00000280|Drug|Nimodipine|
16393777|NCT00000279|Drug|Clonidine|
16393778|NCT00000278|Drug|Disulfiram|
16393779|NCT00000277|Drug|Mazindol|
16393780|NCT00000276|Drug|Bupropion|
16393781|NCT00000275|Drug|Flupenthixol|
16393782|NCT00000274|Drug|Flupenthixol|
16393783|NCT00000273|Drug|opiates|prescription opioids
16393784|NCT00000271|Drug|Desipramine|Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
16393785|NCT00000271|Drug|Placebo|Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
16393786|NCT00000270|Drug|Cocaine|
16393787|NCT00000269|Drug|Pergolide|
16393788|NCT00000268|Drug|Bupropion|
16393789|NCT00000267|Drug|Risperidone|
16393790|NCT00000266|Drug|Flupenthixol|
16393791|NCT00000264|Drug|30% Nitrous oxide|
16393792|NCT00000264|Other|0.35 g/Kg ethanol|
16393793|NCT00000264|Other|0.7 g/Kg ethanol|
16393794|NCT00000264|Other|0 g/Kg ethanol|
16393795|NCT00000263|Drug|30% Nitrous oxide|
16393796|NCT00000263|Other|0.25 g/Kg ethanol|
16393797|NCT00000263|Other|0.5 g/KG ethanol|
16393798|NCT00000263|Other|0 g/Kg ethanol|
16393799|NCT00000262|Drug|30% Nitrous oxide|
16393800|NCT00000262|Drug|0.4% Sevoflurane|
16393801|NCT00000262|Drug|0.2% sevoflurane|
16393802|NCT00000262|Other|Placebo|
16393803|NCT00000261|Drug|30% Nitrous oxide|
16393804|NCT00000261|Other|Placebo|No drug (100% oxygen)
16393805|NCT00000261|Drug|0.2% sevoflurane|
16393806|NCT00000261|Drug|0.4% sevoflurane|
16393807|NCT00000261|Drug|0.6% sevoflurane|
16393808|NCT00000260|Drug|Nitrous oxide|
16393809|NCT00000259|Drug|15 % Nitrous oxide|
16393810|NCT00000259|Drug|0.3 % Sevoflurane|
16393811|NCT00000259|Drug|30% Nitrous oxide|
16393812|NCT00000259|Drug|0.6% Sevoflurane|
16393813|NCT00000259|Other|Placebo|
16393814|NCT00000258|Drug|Nitrous oxide 10% & placebo|
16393815|NCT00000258|Drug|Nitrous oxide 20% & placebo|
16393816|NCT00000258|Drug|Nitrous oxide 30% & placebo|
16393817|NCT00000258|Drug|Nitrous oxide 40% and placebo|
16393818|NCT00000257|Drug|0% N2O and 10% N2O|
16393819|NCT00000257|Drug|0% N2O and 20% N2O|
16393820|NCT00000257|Drug|0% N2O and 30% N2O|
16393821|NCT00000257|Drug|0% N2O and 40% N2O|
16393822|NCT00000256|Drug|20% N2O|
16393823|NCT00000256|Drug|40% N2O|
16393824|NCT00000256|Drug|60% N2O|
16393825|NCT00000256|Drug|80% N2O|
16393826|NCT00000255|Drug|Nitrous oxide|
16393827|NCT00000254|Drug|40% Nitrous oxide|Used as pain assay positive control
16393828|NCT00000254|Other|Sham comparator|0% isoflurane in oxygen
16393829|NCT00000254|Drug|0.2% isoflurane|
16393830|NCT00000254|Drug|0.4% isoflurane|
16393831|NCT00000254|Drug|0.6% isoflurane|
16393832|NCT00000253|Drug|10% N2O|
16393833|NCT00000253|Drug|20% N2O|
16393834|NCT00000253|Drug|30% N2O|
16393835|NCT00000253|Drug|40% N2O|
16393836|NCT00000252|Drug|0% N2O|
16393837|NCT00000252|Drug|10% N2O|
16393838|NCT00000252|Drug|20% N2O|
16393839|NCT00000252|Drug|30% N2O|
16393840|NCT00000252|Drug|40% N2O|
16393841|NCT00000251|Drug|30% N2O|
16393842|NCT00000251|Drug|0.2% isoflurane|
16393843|NCT00000251|Drug|0.4% isoflurane|
16393844|NCT00000251|Other|100% oxygen|Placebo
16393845|NCT00000250|Drug|0% N2O|Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water
16393846|NCT00000250|Drug|40% N2O|Subjects will inhale 40% N2O then immerse forearm in warm water and cold water
16393847|NCT00000249|Drug|20% N2O|20% inhaled N2O
16393848|NCT00000249|Drug|30% N2O|30% inhaled N2O
16393849|NCT00000249|Drug|40% N2O|40% inhaled N2O
16393850|NCT00000248|Drug|Pergolide|
16393851|NCT00000246|Drug|Flumazenil|
16393852|NCT00000245|Drug|Desipramine|
16393853|NCT00000244|Drug|Dynorphin 1 - 13|
16393854|NCT00000243|Drug|Buprenorphine|
16393855|NCT00000242|Drug|Carbamazepine|
16393856|NCT00000241|Drug|Flupenthixol|
16393857|NCT00000240|Drug|Buprenorphine|
16393858|NCT00000239|Drug|Buprenorphine|
16393859|NCT00000238|Drug|Buprenorphine|
16393860|NCT00000237|Drug|Buprenorphine|
16393861|NCT00000236|Drug|Buprenorphine/naloxone|
16393862|NCT00000235|Drug|Buprenorphine|
16393863|NCT00000234|Drug|Buprenorphine|
16393864|NCT00000233|Drug|Buprenorphine|
16393865|NCT00000232|Drug|Buprenorphine|
16393866|NCT00000231|Drug|Buprenorphine|
16393867|NCT00000230|Drug|Buprenorphine|
16393868|NCT00000229|Drug|Buprenorphine|
16393869|NCT00000228|Drug|Buprenorphine|
16393870|NCT00000227|Drug|Buprenorphine|
16393871|NCT00000226|Drug|Buprenorphine|
16393872|NCT00000225|Drug|Buprenorphine|
16393873|NCT00000224|Drug|Buprenorphine|
16393874|NCT00000223|Drug|Buprenorphine|
16393875|NCT00000222|Drug|Buprenorphine|
16393876|NCT00000221|Drug|Buprenorphine|
16393877|NCT00000220|Drug|Buprenorphine|
16393878|NCT00000219|Drug|Buprenorphine|
16393879|NCT00000218|Drug|Carbamazepine|
16393880|NCT00000217|Drug|Carbamazepine|
16393881|NCT00000216|Drug|Buprenorphine|
16393882|NCT00000215|Drug|Pergolide|
16393883|NCT00000214|Drug|Buprenorphine|
16393884|NCT00000213|Drug|Fluoxetine|
16393885|NCT00000212|Drug|Desipramine|
16393886|NCT00000211|Drug|Buprenorphine|
16393887|NCT00000210|Drug|Buprenorphine|
16393888|NCT00000209|Drug|Buprenorphine|
16393889|NCT00000208|Drug|Buprenorphine|
16393890|NCT00000207|Drug|Buprenorphine|
16393891|NCT00000206|Drug|Buprenorphine|
16393892|NCT00000205|Drug|Buprenorphine|
16393893|NCT00000204|Drug|Buprenorphine|
16393894|NCT00000203|Drug|Buprenorphine|
16393895|NCT00000202|Drug|Buprenorphine|
16393896|NCT00000201|Drug|Selegiline|
16393897|NCT00000200|Drug|Methadone|normal maintenance dose
16393898|NCT00000199|Drug|Piracetam|
16393899|NCT00000198|Drug|Piracetam|
16393900|NCT00000197|Drug|Propranolol|
16393901|NCT00000196|Drug|Naltrexone|
16393902|NCT00000195|Drug|Naltrexone|
16393903|NCT00000194|Drug|Cycloserine|
16393904|NCT00000193|Drug|Gamma hydroxybutyric|
16393905|NCT00000192|Drug|Lamotrigine|
16393906|NCT00000191|Drug|Carbamazepine|
16393907|NCT00000190|Procedure|Parotid Gland|
16393908|NCT00000189|Drug|Gepirone|
16393909|NCT00000188|Drug|Selegiline|
16393910|NCT00000187|Drug|Ritanserin|
16393911|NCT00004640|Drug|Chlorhexidine rinse|chlorhexidine solution on tooth loss in low income
16393912|NCT00004639|Procedure|Furlow double z-plasty palatoplasty palate repair|
16393913|NCT00004639|Procedure|Von Langenbeck palatoplasty palate repair|
16393914|NCT05082363|Combination Product|C4d evaluation in lupus nephritis in serum and renal tissue|C4d plasma levels were analyzed by a unique assay specifically detecting C4d arising from complement activation and C4 plasma levels were quantified with competitive ELISA. SLE patients in activitity with and without lupus nephritis In patient with lupus nephritis we will evaluate the C4d after developing remission in the form of reduction of proteinurea less than .5g/g measured as PCR as complete response and less than50% reduction in proteinurea in partial response according to KIDGO guide line Percutaneous renal biopsies were performed in SLE and non-SLE patients under ultrasonographic guidance. 10% formalin-fixed tissue was embedded in paraffin. Four μm-thick sections were stained with hematoxylin and eosin (H&E), periodic acid-Schiff (PAS), periodic acid methenamine silver (PAM), masson-trichrome and polyclonal rabbit anti-human C4d antibody, Renal biopsy specimens of SLE patients were assessed using the most recent modification of the World Health Organization (WHO)
16393915|NCT05082350|Dietary Supplement|black garlic|Daily consumption of 4 cloves of black garlic, not cooked, during 12 weeks
16393916|NCT05082337|Device|SAVVY guidewire|The SAVVY guidewire will be used for rapid pacing runs, valve delivery and for left ventricular pressure measurements pre- and post-THV deployment
16393918|NCT05082311|Other|Observational study|This is an observational study
16393919|NCT05082298|Behavioral|Dental FearLess app|Dental FearLess, is a self-administered psychoeducational intervention that will be accessed by participants via their personal smart device (In other words, this is an online application in which investigators present information about dental procedures. The user selects the procedure on which they would like information and then views a brief video on the selected procedure. It uses evidence-based tools to help participants manage their thoughts, feelings, and behavior related to dental fear to reduce fear during encounters with dental professionals.
16393920|NCT05082298|Behavioral|In-Chair Treatment Protocol|This session is a 1-hour-in-person Cognitive Behavioral Therapy (CBT) dental fear session by study staff at the dental office. Participants will practice managing their thoughts, behaviors, and/or feelings when exposed to stimuli that they report still fearing. After each practice situation, the mental health provider and participant discuss the disconfirmatory evidence generated by the situation.
16393928|NCT05082246|Other|Conscious Breathing|During the Conscious Breathing session, participants will be asked to sit comfortably and with gently closed eyes. Participants will be guided through several different kinds of breathing techniques, where the will focus will be on the expansion of the chest or abdomen, releasing all tension from the body, and visualizing breathing light into the body.
16393929|NCT05082246|Other|Heartfulness Meditation|During the Heartfulness Meditation session, participants will be asked to sit comfortably and with gently closed eyes. Starting with the feet and working towards the head, participants will be asked to relax each part of the body. Then participants will focus on the heart and imagine it filled with light and love. Participants will sit in this relaxed state for a few minutes to allow all stress and cares to be released.
16393951|NCT05082051|Drug|Part B|"Randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after multiple oral dose administration in healthy adult subjects.
~It will evaluate multiple dose administration of CDX-7108 at an appropriate low (50 000 lipase units), mid (150 000 lipase units), and high dose (250 000 lipase units) 4 times a day (QID) for 6 consecutive days in 3 sequential cohorts of 6 subjects each."
16394148|NCT05077072|Procedure|Electroencephalography|Undergo EEG
16393930|NCT05082246|Other|Emotional Freedom Technique|"During the Emotional Freedom Technique session, participants will be asked to tap lightly on several acupressure points while saying a variety of statements regarding pain, anxiety, depression or stress. As participants tap on the acupressure points, participants will repeat phrases of affirmation and acceptance, and also talk through how pain, anxiety, depression or stress may cause distress but can learn to release these feelings. participants will be given a picture of where each of the acupressure points lie on the face, chest or head, and will also be given a script of what to say while tapping on each acupressure point. In addition, participants will be given a description of what each acupressure point means - its associated organ and what emotion that point helps to release."
16393931|NCT05082233|Drug|SHR7280 tablets|Treatment group A:SHR7280 tablets ; 300mg BID； Treatment group B:SHR7280 tablets ; 200mg BID； Treatment group C:SHR7280 tablets ; 200mg QD； Treatment group D:SHR7280 tablets ; 400mg BID；
16393932|NCT05082220|Procedure|epidural catheterization|epidural catheterization using midline or paramedian approach
16393935|NCT05082194|Procedure|balance with open and closed eyes|"The UNTERBERGER TEST. The subjects performed the test once with their eyes open and then with their eyes closed. The participant's task was to assume a standing position with legs apart at hip-width and then walk in place (50 steps).
~Static and dynamic balance testing on the Biodex SD balance platform. Moreover, both during the Unterberger functional test and the tests on the Biodex SD balance platform, the muscle tone was assessed in the subjects using the Luna EMG device. Before starting the tests, surface electrodes were glued to the patient's body (according to the SENIAM procedure). Five surface electrodes were used, consisting of three channels. They were placed on the abdomen of the right sternocleidomastoid muscle, two more were placed on the left longus colli muscle, and one reference electrode on the right shoulder process of the scapula. After each completed test, an ongoing test report was generated."
16393938|NCT05082168|Device|Capnodynamic monitoring|"In patients fully synchronized with mechanical ventilation, the capnodynamic method calculates the effective pulmonary blood flow, the end-expiratory lung volume and estimates the mixed venous oxygen saturation. The capnodynamic method uses short inspiratory or expiratory pauses to induce small changes in CO2 concentration the enable the mole balance to be resolved for the capnodynamic equation:
~ELV x [(FACO2(n)-FACO2(n-1)] = delta(n) x EPBF [CvCO2(n)] - VTCO2."
16393941|NCT05082142|Drug|Tranexamic acid|Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
16393942|NCT05082129|Device|TransiCap|The TransiCap device consists of small, completely inert mini-capsules that, once ingested, can be imaged inside the gastrointestinal tract using MRI, thereby creating a new MRI alternative to the radiopaque marker X-ray test to measure gut transit. The MRI mini- capsules are visualised in the gut using a single fat, water, in-phase and out-of-phase scan.
16393944|NCT05082103|Other|Enzyme lozenge 1|Participants are instructed to take one enzyme containing lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
16393945|NCT05082103|Other|Enzyme lozenge 2|Participants are instructed to take one lozenge with 3x higher enzyme concentration three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
16393946|NCT05082103|Other|Placebo lozenge|Participants are instructed to take one placebo lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
16393949|NCT05082064|Diagnostic Test|arterial blood gases and serum electrolytes|arterial bloog gases parameters serum potassium serum sodium serum calcium
16393950|NCT05082051|Drug|Part A|"Randomized, double-blind, placebo-controlled dose escalation part to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single oral dose administration in healthy adult subjects.
~Single-dose administration of CDX-7108 at the following anticipated dose levels. 10 000, 50 000, 150 000, 250 000, and 500 000 lipase units will be evaluated in 5 sequential cohorts of 6 subjects each."
16401833|NCT02294461|Drug|Placebo|Oral
16401834|NCT02276885|Radiation|PBI Radiotherapy 6 Gy|Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days
16401835|NCT02276885|Radiation|PBI Radiotherapy 8 Gy|Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day
16393952|NCT05082051|Drug|Part C|"Randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI.
~A total of 10 subjects with severe EPI from partial/total pancreatectomy or chronic pancreatitis will be enrolled. It is anticipated that Part C (POC study) will commence after completion of the third single-dose cohort from Part A (SAD study) and following SRC review of the data from this cohort."
16393953|NCT05082038|Device|Mandibular partial rehabilitation with IF Tapared implants|2 IF Tapared Implants (Group IF) on one side of the mandible
16393954|NCT05082038|Device|Mandibular partial rehabilitation with CF Tapared implants|2 CF Tapared Implants (Group CF) on the other side of the mandible
16393955|NCT05082025|Drug|Copanlisib|Given by IV
16393956|NCT05082025|Drug|fulvestrant|Given by IM
16393957|NCT05082012|Device|Treatment of Hallux Valgus|Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.
16393958|NCT05081999|Other|Medical Assessment|medical hx, events inquiry, adherence to treatment arm periodically over 4 years
16393959|NCT05081999|Other|Quality of Life Assessment|online questionnaires periodically over 4 years, including SAQ, EQ-5D-5L, IIEF-5 (males) or FSFI (females)
16393960|NCT05081986|Device|Transcranial Magnetic Stimulation|Single-pulse transcranial magnetic stimulation and theta-burst stimulation
16393961|NCT05081986|Drug|Cycloserine|Cycloserine 100mg
16393962|NCT05081986|Drug|Placebo Oral Tablet|Placebo capsule matched to cycloserine capsule
16393963|NCT05081973|Other|A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score|"Parameters to be recorded before and after extubation to create a new dual extubation model from all babies who met the extubation criteria included in the study:
~Lung ultrasound score: Lung ultrasound will be performed prior to the extubation and after the extubation. Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0 to 3 points will be given for each area (Total score ranges from 0 to 18 points).
~Probability of Successful Extubation: It will be calculated by extubation readiness estimator provided by the website named http://extubation.net/.
~This parameter will be calculated only 1 hour prior to the scheduled extubation time."
16393964|NCT05081947|Behavioral|COMPASS|COMPASS is a web-based intervention (online CBT program) that was developed for managing illness-related anxiety and depression in patients with long-term conditions (LTC) (https://compass-ltc.org/). An example of the patient login page can be viewed here: www.compass-southwark.co.uk. COMPASS aims to support people in managing the challenges of living with a long-term condition. COMPASS is based on research which shows the benefit of combining mental and physical healthcare. The proposed COMPASS program consists of 11 online sessions for patients to work through over approximately 12 weeks. The sessions can be worked through in any order the patient would like. The sessions are split into four quadrants - North, East, South and West - which explore different elements of managing the LTC challenges that were identified from the evidence-based systematic review. Sessions contain information, interactive tasks, goal setting and patient stories.
16393965|NCT05081934|Behavioral|A-CRA|12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. The average time for a placement within SiS is for boys 5,9 months and for girls 4,5 months. To further adjust A-CRA to the closed institutional care, frequency of sessions may be increased to twice a week. This is to facilitate maintaining of focus in treatment and closely follow treatment progress. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to youth individual goals and needs.
16393966|NCT05081934|Behavioral|TAU|Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS.
16393967|NCT05081921|Drug|MesoCellA-Ortho administration|"Single dose of MesoCellA-Ortho product consisting of 20 mln of autologous adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) will be administrated intraarticularly in patients enrolled in MesoCellA-Ortho- treated groups."
16393968|NCT05081921|Drug|HA administration|"Single dose of hyaluronic acid (HA) will be administrated intraarticularly as an active control in patients enrolled in Control Patients groups."
16393969|NCT05081908|Procedure|Radiosurgery|Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife
16393970|NCT05081895|Device|Electrical Impedance tomography|Patients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes.
16393971|NCT05081895|Other|Lung mechanics and gas exchange|Patient lung mechanics and gas exchange will be monitored during routine clinical care, with specific attention to postural changes and use of neuromuscular blockade.
16393972|NCT05081882|Drug|Kava|Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.
16393973|NCT05081882|Drug|Placebo|Participants on this arm will take one placebo capsule orally three times daily for 28 days.
16393974|NCT05081869|Other|Exercise Program|An online yoga-based exercise program will be applied for 16 sessions in individuals' own environments. The exercise program will consist of stretching, mobilization, stabilization, strengthening and relaxation exercises.
16393975|NCT05081869|Other|Education Program|There will be video training on the subject for both groups.
16393976|NCT05081856|Other|mobilization with moduler medical equipment carring vehicle|Mobilization of the patients was carried out with the vehicle in their modular vehicle.
16394140|NCT05080621|Drug|binimetinib|15 mg tablets
16393979|NCT05081830|Behavioral|Transdiagnostic online intervention|Based on the theoretical proposal of Barlow et al. (2011) a treatment applicable to all anxiety and mood disorders (unipolar depression) will be implemented. The unified protocol incorporates proven emotion-focused psychological techniques (Ellard et al., 2010). The main components are: (1) motivation for change, understanding emotions, and recognition and observation of emotional response; (2) learn to observe experiences, evaluate and reevaluate thoughts; (3) what is emotional avoidance, emotion and behavior, and awareness and tolerance of physical sensations; (4) emotional exposure to physical sensations and situations and achievements, maintenance and prevention of relapses.
16393980|NCT05081830|Behavioral|TCC online intervention|This program incorporates psychological techniques under the cognitive-behavioral model that have demonstrated their effectiveness in online mode (De la Rosa, 2019; Flores et al., 2014). The main components are: (1) psychoeducation, (2) cognitive restructuring, (3) identification and expression of emotions, (4) assertiveness training and (5) problem solving, and (6) relapse prevention. The order of application of each technique is established by the advisor derived from the formulation of treatment of each case to solve the problems raised, under supervision.
16393982|NCT05081791|Behavioral|Exercise Training|12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.
16393983|NCT05081778|Behavioral|Obese patient following a medical course|Questionnaires for the assessment of dissociative disorders in obese patients : DES scale of Carlson and Putman, SDQ-20 of Nijenhuis, comorbidities, Dutch Eating Behaviour Questionnaire (DEBQ), questionnaire of Rosenberg
16393984|NCT05081765|Drug|Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)|correlation between C through and taken drug
16393985|NCT05081765|Device|Lynparza|correlation between C through and taken drug
16393986|NCT05081752|Device|OTSC Stentfix|Stent placement with fixation of the esophageal stent using OTSC Stentfix.
16393987|NCT05081752|Procedure|Stent Suturing / Endoscopic Clips|Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.
16393989|NCT05081726|Diagnostic Test|Functional MRI|Series of MRI scans of the brain
16393990|NCT05081713|Behavioral|high-intensity training focused on stepping in variable contexts|Approximately 10 weeks (~30 sessions) of high-intensity training
16393992|NCT05081687|Drug|Folfirinox|5-FU 2400mg/m2; Oxaliplatin 85 mg/m2, Irinotecan 150mg/m2
16393993|NCT05081674|Drug|Alectinib|600mg 1OD
16393994|NCT05081674|Drug|Pembrolizumab|200mg every 21 days
16393995|NCT05081674|Drug|Nivolumab|6mg/kg every 4 weeks
16393996|NCT05081674|Drug|Erlotinib|150mg
16393997|NCT05081661|Other|Motor Imagery Program|The intervention group of the study will undergo standard postoperative physical therapy treatment at their therapist. Beginning on the third day after surgery, the participant will begin an motor imagery program to be performed three times a week for four weeks. A session lasts between fifteen and twenty minutes. It begins with a body awareness phase followed by a series of three to five one-minute exercises to be repeated three times, with a one-minute break between each exercise. The program is performed independently at home using a standardized audio tape.
16393998|NCT05081661|Other|Placebo program|"The control group of the study will undergo standard postoperative physiotherapy treatment at their therapist. On the third day after surgery, the participant will begin a relaxation program inspired by the mindfulness tool called Bodyscan that acts as a placebo mental imagery program. Nevertheless, the program created for this technique does not follow the Bodyscan guidelines (Jon Kabat-Zinn, 2005), as we do not want there to be any effects in favor of improved body perception on the participants, which could bring an additional biai to the study. For the sake of understanding, we have used the term body visualization in the various documents distributed to the participants. The program is to be performed three times a week for four weeks. A session lasts between ten and fifteen minutes. The program is performed independently at home using a standardized audio tape."
16393999|NCT05081648|Procedure|CT MuST|Multiple Single Cannulation Technique (MuST): Experimental technique
16394000|NCT05081648|Procedure|Rope-ladder cannulation technique|Standard cannulation technique( Rope-ladder)
16394002|NCT05081609|Drug|TransCon IL-2 β/γ|TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
16394003|NCT05081609|Drug|Pembrolizumab|Pembrolizumab will be administered as an intravenous (IV) infusion
16394004|NCT05081609|Drug|Chemotherapy drug|SOC chemotherapy will be administered as an intravenous (IV) infusion
16394005|NCT05081596|Behavioral|PATH-Pain|"The goals of PATH-Pain are to: 1) Teach problem solving skills to reduce negative emotions, by using emotion regulation and problem- solving strategies to overcome these difficulties. 2) Use compensatory strategies and environmental adaptation tools (notes, checklists, calendars, etc.) to avoid limitations resulting from memory problems, help improve emotion regulation, and create an easier environment to live in. If found helpful and participant agrees, a tablet application called WellPATH will be used to help the subject with emotion regulation techniques. The tablet will be given at the beginning of treatment and will be returned at the end of treatment. 3) Invite caregiver participation, when appropriate.
~Subjects in the PATH-PAIN group will receive 8 weekly sessions (first 8 weeks) with a study therapist and 6 monthly phone sessions (3 individual and 3 group) for 9-36 weeks. Each session will last approximately 50 minutes."
16406100|NCT05093205|Drug|Midazolam|Syrup
16406101|NCT05093205|Drug|Levonorgestrel & Ethinyl Estradiol|Tablet
16406102|NCT05093192|Other|Exercise trial|Participants will perform a supervised acute bout of aerobic exercise over 20-30 minutes, corresponding to a target power output at an intensity +10 to 15% above ventilatory threshold.
16406103|NCT05093166|Drug|"Ex vivo expanded autologous human oral epithelium containing stem cells"|The treatment includes a single administration of investigational product through a dedicated surgical procedure of penis wound bed preparation, epithelial surface adaption and product application followed by urethra tubularization and penis reconstruction.
16409946|NCT00000647|Drug|Zidovudine|
16409947|NCT00000647|Drug|Interferon alfa-n1|
16409948|NCT00000647|Procedure|Peripheral lymphocyte infusion|
16394008|NCT05081570|Device|telecare consultation|Two tertiary stroke care consultations will be provided by stroke nurses via telecare in 2 months. Consultation content includes provide education on modifying stroke-specific risk factors, disseminate self-management knowledge, reinforce the importance of medication compliance, revise the blood and investigation results, and co-design and follow-up on mutually agreed rehabilitation goals with the subjects. When necessary, the nurse will also refer the stroke survivors to multidisciplinary team members according to the referral guidelines. The nurse will also encourage the patients' family and/or informal caregivers to participate in the consultations.
16394010|NCT05081518|Drug|Lu AG06466|Lu AG06466 - capsule
16394011|NCT05081518|Drug|Placebo|Placebo - capsule
16394012|NCT05081505|Behavioral|Structural exercise course|12-week structured exercise class, team competition, social support, and incentive strategy
16394013|NCT05081505|Behavioral|Autonomous group class|12-week autonomous group class, team competition, social support, and incentive strategy
16394016|NCT05081466|Other|Dietary pattern|(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)
16394017|NCT05081466|Other|Fruit and vegetable intake|Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire
16394018|NCT05081466|Other|Meat intake|Red meat, poultry, processed meat from food frequency questionnaire
16394019|NCT05081466|Other|Fish intake|Intake of fish from food frequency questionnaire
16394020|NCT05081466|Other|Egg intake|Intake of eggs from food frequency questionnaire
16394021|NCT05081466|Other|Dairy intake|Intake of dairy products from food frequency questionnaire
16394022|NCT05081466|Other|Tea intake|Intake of tea (drink) from food frequency questionnaire
16394023|NCT05081466|Other|Coffee intake|Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire
16394024|NCT05081466|Other|Tea and coffee intake|Combined intake of tea and coffee from food frequency questionnaire
16394025|NCT05081466|Other|Protein intake|Estimated intake of protein, derived from food frequency questionnaire
16394026|NCT05081466|Other|Calcium intake|Estimated intake of calcium, derived from food frequency questionnaire
16394027|NCT05081466|Other|Vitamin D intake|Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake
16394028|NCT05081453|Device|pavlik harness|The application of a pavlik harness will be carried out in the intervention group. It will follow a protocol similar to that of the treatment of hip dysplasia in terms of follow-up and safety
16394029|NCT05081414|Behavioral|Program for Teaching Self-Care in HF (PEAC-IC)|As described previously
16394030|NCT05081401|Other|This is a non-intervention observational study.|No applicable intervention. This is a secondary data analysis observational study.
16394031|NCT05081388|Drug|REGN14256|Sub-cutaneous (SC) single dose
16394032|NCT05081388|Drug|imdevimab|SC single dose
16394033|NCT05081388|Drug|casirivimab + imdevimab|SC single dose
16394034|NCT05081388|Drug|Placebo|SC single dose
16394035|NCT05081375|Drug|Enoxaparin Injectable Product|Not holding prophylaxis dose prior to surgical procedure
16394036|NCT05081375|Drug|Sodium chloride|Holding prophylaxis dose of Enoxaparin replacing with placebo
16394042|NCT05081323|Behavioral|Self-applied treatment for phobias|The proposed treatment consists of four stages that use different visual elements to represent and replace a real rat in a gradual exposure treatment for specific phobia for animals. With the order of the stages, the intensity of the phobic stimulus increases. In each stage the participant is gradually exposed to a certain amount of elements that represent a phobic situation or object. Graduality considers an approach with realism, interaction, and intensity. The treatment also includes a virtual therapeutic assistant that guides, provides information, and tries to reduce any alteration captured by the participant's heart rate monitoring through deep breathing exercises.
16394043|NCT05081310|Device|superior vena cava isolation|SVC isolation by the means of cryoballoon
16394044|NCT05081310|Device|pulmonary vein isolation|conventional pulmonary vein isolation by the means of cryoballoon
16394045|NCT05081297|Other|Qigong|Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.
16394046|NCT05081284|Device|Volume-stable collagen matrix Geistlich Fibro-Gide®|"After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures.
~Control group will not receive soft tissue augmentation."
16394047|NCT05081271|Biological|Homologous booster|Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa
16394141|NCT05080608|Other|Surgery|Treatment according to clinical practise
16394048|NCT05081271|Biological|Heterologous booster|Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa
16394049|NCT05081258|Procedure|passive Alveolar Molding|A passive palate plate (passive Alveolar Molding) will be inserted within the first week after birth. The pAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and the treatment with the pAM appliance will continue until palate closure (10-12 months of life).
16394050|NCT05081258|Procedure|Nasoalveolar Molding|A passive palate plate will be inserted within the first week after birth. A nasal stent will be added to the palate plate after one week (NAM appliance). The NAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and will be treated with a passive palate plate without nasal stent until palate closure (10-12 months of life).
16394051|NCT05081245|Drug|ML-004 (IR)/(ER) tablet|Participants will receive ML-004 once daily for up to 16 weeks.
16394052|NCT05081245|Drug|ML-004 Placebo|Participants will receive matching placebo once daily for up to 16 weeks
16394053|NCT05081232|Device|MLG (Multi-Layered Perinatal Issue Allograft) Allograft|"MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing.
~MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick.
~Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly."
16394054|NCT05081219|Drug|Insulin (Humulin® R U-100)|Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
16394055|NCT05081219|Drug|Empagliflozin 10 MG|Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
16394056|NCT05081219|Device|Aptar Pharma CPS Intranasal Delivery Device|Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
16394057|NCT05081219|Drug|Placebo (Insulin Diluent)|Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
16394058|NCT05081219|Drug|Placebo (Capsules)|Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.
16394061|NCT05081193|Drug|Testosterone Undecanoate|198mg taken twice daily
16394062|NCT05081193|Drug|Enzalutamide|160mg taken once daily
16394063|NCT05081180|Drug|Avelumab|Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive intravenous infusion at a flat dose or weight based dose of Avelumab, every 2 weeks (Q2W) until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when Maximum tolerated dose (MTD) and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.
16394064|NCT05081180|Drug|Lenvatinib|Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive daily oral escalated dose level of Lenvatinib until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when MTD and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE of Lenvatinib in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.
16394065|NCT05081167|Drug|REL-1017|REL-1017 tablet
16394066|NCT05081167|Drug|Placebo|Placebo tablet
16394067|NCT05081154|Other|Product A|P1012915, a nicotine pouch with 8 mg nicotine
16394068|NCT05081154|Other|Product B|P1013018, a nicotine pouch with 10 mg nicotine
16394069|NCT05081154|Other|Product C|P1013015, a nicotine pouch with 8 mg nicotine
16394070|NCT05081154|Other|Product D|P1012815, a nicotine pouch with 8 mg nicotine
16394071|NCT05081154|Other|Product E|P1013315, a nicotine pouch with 8 mg nicotine
16394072|NCT05081154|Other|Product F|P1013115, a nicotine pouch with 8 mg nicotine
16394073|NCT05081154|Other|Product G|P1013215, a nicotine pouch with 8 mg nicotine
16394074|NCT05081141|Diagnostic Test|Diagnostic test for HHV8 exposure|Venipuncture for blood sampling
16394075|NCT05081128|Device|programmable CSF shunt valve|Brain shunt surgery using a programmable CSF shunt valve
16394142|NCT05080595|Other|Transportation assistance (Lyft rides)|Lyft rides will be provided to patients for any transplant-related medical visits
16394143|NCT05080582|Behavioral|Mother-Scented Simulated Hand|Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures
16412181|NCT00000743|Drug|Zidovudine|
16412182|NCT00000734|Drug|Sulfamethoxazole-Trimethoprim|
16412183|NCT00000734|Drug|Zidovudine|
16412184|NCT00000723|Drug|Methotrexate|
16412185|NCT00000723|Drug|Leucovorin calcium|
16412186|NCT00000723|Drug|Zidovudine|
16412187|NCT00000723|Drug|Dexamethasone|
16412188|NCT00000721|Drug|CD4 Antigens|
16414192|NCT00000902|Drug|Zidovudine|
16414193|NCT00000902|Drug|Zalcitabine|
16414194|NCT00000902|Drug|Didanosine|
16414195|NCT00000899|Drug|Nelfinavir mesylate|
16414196|NCT00000899|Drug|Lamivudine|
16414197|NCT00000899|Drug|Filgrastim|
16414198|NCT00000899|Drug|Stavudine|
16414199|NCT00000899|Drug|Cyclophosphamide|
16414200|NCT00000898|Drug|Ritonavir|
16414201|NCT00000898|Drug|Nelfinavir mesylate|
16414202|NCT00000898|Drug|Saquinavir|
16414203|NCT00000896|Drug|Indinavir sulfate|
16414204|NCT00000896|Drug|Lamivudine/Zidovudine|
16414205|NCT00000896|Biological|Hepatitis A Vaccine (Inactivated)|
16414206|NCT00000896|Drug|Interleukin-12|
16414207|NCT00000896|Drug|Nevirapine|
16414208|NCT00000896|Drug|Stavudine|
16414209|NCT00000896|Drug|Sargramostim|
16414210|NCT00000895|Drug|Nelfinavir mesylate|
16414211|NCT00000895|Drug|Nevirapine|
16394080|NCT05081102|Drug|FDC of oxycodone 5 mg/ibuprofen 400 mg|receive one (1) experimental drug tablet (FCD of oxycodone 5mg/ibuprofen 400mg) + one (1) Tylex® placebo.
16394081|NCT05081102|Drug|Tylex|receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet
16394082|NCT05081089|Drug|Artemether-lumefantrine|Tablets containing 20/80 mg artemether and 120/480 mg lumefantrine will be administered according to weight as per manufacturer guidelines.
16394083|NCT05081089|Drug|Primaquine Phosphate|The single dose of 0.25mg/kg PQ will be administered in an aqueous solution, according to a standard operating procedure (SOP) provided by the manufacturer.
16394084|NCT05081089|Drug|Sulphadoxine-pyrimethamine with amodiaquine|Sulfadoxine/pyrimethamine tablets contain 500mg sulfadoxine and 25mg pyrimethamine. Amodiaquine tablets contain 150mg amodiaquine (as hydrochloride). Tablets will be administered according to weight as per manufacturer guidelines.
16394085|NCT05081089|Drug|Tafenoquine|100mg tafenoquine tablets are prepared into a 1mg/mL solution in water. Solution will be given according to weight as indicated per treatment arm in 5kg bands.
16394086|NCT05081076|Device|Glazing|The zirconia surface will be submitted to a vitrification procedure (glazing) in a specific ceramic oven using the Ceramill Stain & Glaze Kit, following the manufacturer's instructions.
16394087|NCT05081076|Device|Polishing|The zirconia surface will be submitted to a polishing procedure using a polishing rubbers kit in the sequence indicated by the manufacturer (EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).
16394089|NCT05081050|Other|Only Follow-up|No intervention is planned.
16394090|NCT05081037|Device|Wearable Care Group|"Continous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning.
~Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels."
16394091|NCT05081024|Procedure|Biopsy|Undergo biopsy
16394092|NCT05081024|Procedure|Biospecimen Collection|Undergo collection of blood and/or tissue samples
16394093|NCT05081024|Other|Electronic Health Record Review|Medical records are reviewed
16394094|NCT05080998|Diagnostic Test|Cxbladder Monitor|Cxbladder Monitor (CxbM) is a high sensitivity and NPV urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
16394095|NCT05080985|Procedure|TPVB|20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.
16394096|NCT05080985|Procedure|ESPB|20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.
16394097|NCT05080985|Drug|Bupivacain|20 ml 0.375 % bupivacaine was injected
16394098|NCT05080972|Behavioral|in-the-kNOW mobile app|"in-the-kNOW is a mobile app with restricted access through a single-use registration code.
~The app will be developed with regular input from Black women enrolled in Atlanta Healthy Start Initiative (AHSI).
~The app will have culturally- and contextually targeted HIV prevention and optimal sexual health messaging.
~Each participant will have 4 months to engage with the app, with e-reminders in time intervals preferred by the participants (a minimum of 3 times per week) via push notifications. During the 4-month study period, participants will receive push notifications to encourage the use of all app domains: My Logger, My Test, My Resources, and My Circle.
~Research staff will complete 2-month check-ins via phone call or video chat with participants."
16394144|NCT05080582|Behavioral|NICU Standard Care|Neonates were placed in a side-lying position, while their extremities were flexed close to the body and wrapped with rolled sheets or towels to simulate the intrauterine posture.
16394147|NCT05077072|Other|Counseling|Participate in CHAT counseling intervention
16414212|NCT00000895|Drug|Azithromycin|
16414213|NCT00000893|Drug|Nelfinavir mesylate|
16414214|NCT00000893|Drug|Efavirenz|
16414215|NCT00000889|Drug|Aldesleukin|
16414216|NCT00000888|Drug|Ritonavir|
16414217|NCT00000888|Drug|Lamivudine|
16414218|NCT00000888|Drug|Zidovudine|
16414219|NCT00000887|Drug|Nelfinavir mesylate|
16414220|NCT00000887|Drug|Lamivudine|
16414221|NCT00000887|Drug|Zidovudine|
16414222|NCT00000886|Biological|HIV-1 C4-V3 Polyvalent Peptide Vaccine|
16414223|NCT00000884|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|Dosage will vary based on route of administration
16414224|NCT00000884|Biological|ALVAC-HIV MN120TMG (vCP205)|Dosage will vary based on route of administration
16414225|NCT00000884|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|Dosage will vary based on route of administration
16414226|NCT00000881|Drug|Cidofovir|
16414227|NCT00000881|Drug|Probenecid|
16414228|NCT00000879|Biological|ALVAC(2)120(B,MN)GNP (vCP1452)|
16414229|NCT00000879|Biological|MN rgp120/HIV-1 and GNE8 rgp120/HIV-1|
16414230|NCT00000879|Biological|ALVAC-HIV MN120TMG (vCP205)|
16414231|NCT00000878|Drug|Lamivudine|
16414232|NCT00000878|Drug|Stavudine|
16414233|NCT00000878|Drug|Zidovudine|
16414234|NCT00000877|Drug|Indinavir sulfate|
16414235|NCT00000877|Drug|Rifabutin|
16414236|NCT00000859|Drug|Indinavir sulfate|
16414237|NCT00000859|Drug|Ritonavir|
16414238|NCT00000859|Drug|Nelfinavir mesylate|
16414239|NCT00000857|Drug|Interleukin-12|
16414240|NCT00000856|Drug|Foscarnet sodium|
16414241|NCT00000856|Drug|Ganciclovir|
16414242|NCT00000854|Drug|Nandrolone decanoate|
16414243|NCT00000850|Drug|Indinavir sulfate|
16414244|NCT00000850|Drug|Sargramostim|
16414245|NCT00000849|Drug|Aldesleukin|
16414246|NCT00000839|Drug|Didanosine|
16414247|NCT00000837|Biological|Varicella Virus Vaccine (Live)|
16414248|NCT00000834|Drug|Lamivudine|
16414249|NCT00000834|Drug|Methotrexate|
16414250|NCT00000834|Drug|Zidovudine|
16414251|NCT00000826|Drug|Clarithromycin|
16414252|NCT00000826|Drug|Rifabutin|
16414253|NCT00000826|Drug|Sulfamethoxazole-Trimethoprim|
16414254|NCT00000826|Drug|Dapsone|
16414255|NCT00000826|Drug|Fluconazole|
16414256|NCT00000825|Drug|Aldesleukin|
16414257|NCT00000822|Drug|Ritonavir|
16414258|NCT00000822|Biological|gp160 Vaccine (Immuno-AG)|
16394099|NCT05080972|Behavioral|Control|"The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on
~Sexual Transmitted Infections (STI)/HIV prevention,
~Family planning, and
~General health promotion (e.g., exercise and diet).
~The control condition provides access to HIV prevention materials that are publicly available but that do not offer the dynamic and individually customized features of the health communication/new media research approach proposed herein.
~Control group participants will continue to receive the usual care associated with Atlanta Healthy Start Initiative (AHSI) enrollment.
~The control group will not have access to intervention content (e.g. commodity ordering) until after the study has concluded.
~Research staff will complete 2-month check-ins via phone call or video chat with participants."
16394100|NCT05080959|Drug|CPL-01|Subjects will receive a single dose
16394101|NCT05080959|Drug|Naropin 150 MG Per 20 ML Injection|Subjects will receive a single dose
16394102|NCT05080959|Drug|Placebo|Subjects will receive a single dose
16394105|NCT05080920|Dietary Supplement|Rosmalip®|Nutritional Supplement+Usual Care
16394106|NCT05080920|Other|Placebo|Placebo+Usual Care
16394107|NCT05080907|Other|Observational|Subjects for observational study Various conditions & healthy subjects
16394108|NCT05080894|Device|Virtual reality|Embodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises.
16394109|NCT05080881|Diagnostic Test|phonocardiographic measurement: InnoVital Systems|The instrument consists of one or more low-profile microphones in plastic housings with nitrile or silicon diaphragms. These sensors convert heart sounds into analog signals that will be acquired by the BIOPAC data acquisition system.
16394110|NCT05080881|Diagnostic Test|phonocardiographic measurement: ThinkLabs StethOne|This device senses heart sounds and may be listened to using headphones and converted to an analog signal and saved using the BIOPAC data acquisition system.
16394111|NCT05080881|Diagnostic Test|physiological measurements: BIOPAC|Non-invasive blood pressure, electrocardiogram, heart rate, respiratory rate, and leg circumference - This is a commercially available device used regularly in health care settings to monitor continual blood pressure and heart rate.
16394112|NCT05080881|Diagnostic Test|physiological measurements: Masimo Radical-7|A commercially available device for pulse oximetry and continuous non-invasive hematocrit measurement.
16394113|NCT05080881|Diagnostic Test|physiological measurements: CoVa Monitoring System 2|This device will be used for thoracic bioimpedance and other physiological measures. This is a commercially available device. It also measures ECG, heart rate, heart rate variability, estimated stroke volume, and estimated cardiac output. The study team may measure either while body bioimpedance or thoracic bioimpedance.
16394114|NCT05080881|Diagnostic Test|Thoracic impedance|Thoracic impedance is measured using the Starling device (https://usstarling.baxter.com/starling-system). Baxter uses a series of proprietary algorithms to infer stroke volume and cardiac output from thoracis impedance. Calculated values will be recorded, but the main variable that will be recorded is simply the temporal profile of thoracic impedance during the manipulations in each group (changing lower body negative pressure or therapeutic phlebotomy).
16394115|NCT05080855|Procedure|modified Millard technique vs Tennison-Randall technique|evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison-Randall technique in unilateral cleft lip (ucl) repair. Inclusion criteria: Patient with ages from 2 months old to 6 months old, Patient with unilateral cleft lip complete or incomplete type.
16394116|NCT05080842|Drug|AC682|Participants will receive AC682 by mouth daily in 28-day cycles.
16394117|NCT05080829|Diagnostic Test|Myeloid mutations measurement|Measure of myeloid mutations by NGS when detection of refractory or relapsed CML is done
16394118|NCT05080816|Dietary Supplement|Parenteral nutrition (PN)|Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
16394119|NCT05080816|Dietary Supplement|Enteral nutrition|Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.
16394120|NCT05080816|Other|Control|Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
16394121|NCT05080803|Drug|intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone|intravitreal administration
16394122|NCT05080790|Drug|Dinutuximab Beta, Zoledronic acid, Interleukin-2|Five 5-week cycles (Q5W) of dinutuximab beta, zoledronic acid and low-dose interleukin (IL-2)
16394123|NCT05080777|Behavioral|Tele-Savvy|A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
16394146|NCT05077072|Other|Best Practice|Receive SOC
16414259|NCT00000822|Drug|Stavudine|
16414260|NCT00000822|Drug|Didanosine|
16414261|NCT00000819|Drug|Prednisone|
16414262|NCT00000809|Biological|Aluminum hydroxide|
16414263|NCT00000809|Biological|QS-21|
16414264|NCT00000809|Biological|MN rsgp120/HIV-1|
16414265|NCT00000793|Drug|Mexiletine hydrochloride|
16414266|NCT00000793|Drug|Benztropine mesylate|
16414267|NCT00000793|Drug|Amitriptyline hydrochloride|
16414268|NCT00000714|Drug|Trimetrexate glucuronate|
16414269|NCT00000714|Drug|Leucovorin calcium|
16414270|NCT00000709|Drug|Zidovudine|
16414271|NCT00000705|Drug|Zidovudine|
16394124|NCT05080777|Behavioral|Caregiving During Crisis (Educational Program)|The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
16394125|NCT05080764|Combination Product|1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)|"Facial acne lesions will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer to the whole face. After drug application, subjects should stay inside for 1 hour. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).
~Other Names:
~ALA-PDT, Ameluz®-PDT"
16394126|NCT05080764|Combination Product|1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)|Facial acne lesions will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer to the whole face. After drug application, subjects should stay inside for 1h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).
16394127|NCT05080764|Combination Product|3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)|"Facial acne lesions will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer to the whole face. After drug application, subjects should stay inside for 3 hours. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).
~Other Names:
~ALA-PDT, Ameluz®-PDT"
16394128|NCT05080764|Combination Product|3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)|Facial acne lesions will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer to the whole face. After drug application, subjects should stay inside for 3h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).
16394131|NCT05080725|Other|TelePEPP intervention|TelePEPP sessions will be conducted twice per week by a Speech Language Pathologist and/or graduate student clinician, on the study team. This clinician will deliver the intervention from the NYU Voice Center using the web conferencing software Webex (institutional license) on a Dell desktop computer with a 3.1 GHz intel core processor and high definition camera. Each exercise set will include 40 repetitions (10 reps of effortful swallows, tongue hold swallows, effortful pitch glides and maximal posterior tongue presses). All exercises are widely-adopted by clinicians as standard of care exercises. The number of sets will be gradually increased as tolerance builds [2 sets in week 1, 3 sets in week 2, 4 sets in weeks 3+].
16394132|NCT05080699|Dietary Supplement|Peptamen Intense VHP, Nestlé Health Science, Switzerland|An enteral formula containing hydrolyzed whey protein, maltodextrin, long-chain triglycerides, medium chain triglycerides (MCT), vitamins and minerals. Compared to standard enteral formula, Peptamen Intense is higher in protein (37 kcal%) and lower in carbohydrates (29 kcal%). The energy content is 1.0 kcal/mL.
16394133|NCT05080686|Device|Posthorax Thoraxbelt|The patients will be assisted to put on the ThoraxBelt after surgery or at the emergency room by our research members and will be asked to keep it on except for showering through the whole study period.
16394134|NCT05080673|Procedure|5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy|The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.
16394135|NCT05080660|Drug|LY356318|Administered orally.
16394136|NCT05080660|Drug|Placebo|Administered orally.
16394138|NCT05080634|Other|Patients who underwent POEM|chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.
16394139|NCT05080621|Drug|Ripretinib|50 mg tablets
16394149|NCT05077072|Behavioral|Neurofeedback|Undergo NFB intervention
16394150|NCT05077072|Other|Questionnaire Administration|Ancillary studies
16394151|NCT05075876|Drug|SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)|Single application for 6 days
16394152|NCT05075876|Drug|SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)|Single application for 6 days
16394153|NCT05075759|Behavioral|Behavioral Intervention|Receive personalized clinician-led self-management telehealth sessions
16394154|NCT05075759|Behavioral|Behavioral Intervention|Receive personalized goal setting for daily steps and activity and dietary goals
16394155|NCT05075759|Behavioral|Behavioral Intervention|Remote sessions with a health coach
16394156|NCT05075759|Other|Survey Administration|Ancillary studies
16394157|NCT05075746|Device|enVista Toric|enVista Toric IOL
16394158|NCT05075746|Device|enVista non-Toric (spherical)|enVista non-Toric (spherical) IOL
16394159|NCT05074888|Drug|Prospekta|Oral administration.
16394160|NCT05074888|Drug|Placebo|Oral administration.
16394161|NCT05073588|Other|Indo Mediterranean diet|Mediterranean diet has been shown to be effective in NAFLD adult patients. In India, it is very difficult to follow Mediterranean diet, so one group will be given Indianized version of mediterranean diet.
16394162|NCT05073588|Other|Calorie restricted diet|One group will be given diet restricted in calories, which most of the patients follow to lose weight
16394163|NCT05072977|Procedure|TransPRK|A Merocel sponge is soaked in a saline solution to expand before being gently applied to the corneal surface in three gestures similar to painting. This standardised procedure avoids inhomogeneous wetting of the cornea, which would result in uneven ablation. The laser ablation is then performed.
16394164|NCT05072977|Procedure|Alcohol PRK|A ring is placed in the centre of the cornea and filled with 20% alcohol. After 20 seconds of exposure, the alcohol is absorbed with a small sponge and the corneal epithelium is debrided with a polyvinyl alcohol expanding sponge (Merocel, Medtronic). The entire cornea is rinsed with balanced salt solution and the epithelium is peeled away from the corneal stroma. The corneal bed is then dried with a small sponge and laser ablation is performed.
16394165|NCT05072171|Procedure|Inguinal hernia repair with dynamic prosthesis|Tissue specimens excised at the above defined postoperative stages were fixed in neutral-buffered 10% formalin and routinely processed to paraffin wax. Sections (4 μm thick) were cut and stored at room temperature until use. Sections were stained with hematoxylin and eosin (H&E) for histological analysis and Azan trichrome (Bioptica) staining to evaluate muscular tissue in the implant fabric.
16394168|NCT05071456|Other|Collects of skin's hydration|Collects of skin's hydration will be made by using patch using electrochemistry.
16394169|NCT05071014|Drug|Pembrolizumab|Pembrolizumab: 200mg/dose delivered by IV infusion
16394170|NCT05071014|Procedure|Image-guided cryoablation|Cryoablation will be used to treat a designated lesion with preference given to a lesion that is symptomatic or at risk of causing symptoms. Per institutional standards, complete ablation of the lesion will be attempted.
16394173|NCT05070273|Diagnostic Test|Hypoglossal nerve conduction study|"NCS of nervus hypoglossus (evaluation of M-response parameters) was carried out using a 4-channel electromyographic machine. The stimulation will be carried out from three points:
~angle of the lower jaw (proximal point),
~the area of the carotid triangle (distal point),
~directly from the electrode of St. Mark when it is localized on the muscles of the tongue.
~The initial stimulation parameters: strength of an electric current 20 mA, stimulus duration 0.2 ms, and frequency 1 Hz. To achieve supramaximal stimulation, the stimulation strength will be increased with a step of 1-2 mA to a maximum of 35 mA, the duration of the stimulus will be increased to 0.3 ms."
16394174|NCT05070273|Diagnostic Test|Transcranial magnetic stimulation of hypoglossal nerve|"TMS will be carried out using a Magstim 200 magnetic stimulator connected with a BiStim module (Magstim Co. Ltd., Whitland, Wales, UK). The generated magnetic pulses will be delivered by the coil 65 mm in diameter tangentially located relative to the scalp in the F7 projection - T3 and F8-T4 (according to the international scheme 10-20). The area of cortical stimulation will be localized by supplying single pulses with gradual increase, with a coil displacement with a step of 1 cm, until the contraction of the facial muscles will be obtained, followed by the determination of the MEP threshold value. Analysis of conduction by cortical-lingual pathway will be performed at TMS with magnetic stimulus intensity 20-30% above the MEP threshold."
16394175|NCT05069376|Device|Ureteral Stent of 5-16 or 5-18|Boston Scientific Polaris™ Ultra Ureteral Stent
16394176|NCT05069376|Device|Ureteral Stent of 5-22 or 5-24|Boston Scientific Polaris™ Ultra Ureteral Stent
16394179|NCT05068102|Drug|BI 765063|BI 765063, for treatment
16394180|NCT05068102|Drug|ezabenlimab|ezabenlimab, for treatment
16394181|NCT05068102|Drug|[89Zr]Zr- BI 765063|[89Zr]Zr- BI 765063, test drug specifically radiolabelled for immune-PET
16394182|NCT05067439|Drug|Abrocitinib|200 mg once daily (QD)
16394183|NCT05067439|Drug|Omeprazole|single doses of 10 mg
16394184|NCT05067439|Drug|Caffeine|single dose of 100 mg
16394185|NCT05067439|Drug|Efavirenz|single doses of 50 mg
16394186|NCT05067270|Drug|Sodium Citrate|Administered SC infusion.
16394187|NCT05067270|Drug|Treprostinil|Administered SC infusion.
16394188|NCT05067270|Drug|Humalog diluent|Administered SC infusion.
16394189|NCT05067270|Drug|Magnesium Chloride|Administered SC infusion.
16394190|NCT05067270|Device|Medtronic™ MiniMed™ 770G pump|Used to administer drug through SC infusion.
16394744|NCT04508023|Drug|Rivaroxaban|Participants will receive rivaroxaban 10 mg tablet orally once daily.
16394191|NCT05066919|Procedure|Open plantar fasciotomy|In the surgical treated group, the plantar fascia is defined percutaneously (medial and lateral margin). An incision is then made just distal to the heel pad medially over the plantar fascia. A resection is performed 1 cm in length with a width corresponding to 50% of the medial band. The skin is sutured with nylon/nonresorbable suture. Postoperatively, the operated foot is elevated for the first 24 hours. Then free mobilization in postoperative shoe (ProCare shoe) is allowed. The dressing is left untouched for 3-5 days, after which it can be changed to a patch. After 14 days the sutures are removed and the patient allowed using regular shoes.
16394192|NCT05066919|Other|Conservative treatment|In the conservative treatment group, patients are instructed in performing stretching exercises with plantar fascia specific stretching exercises 10 x 10 seconds, 3 times daily and high load strength training are every other day for 3 months. Each high load strength exercise consists of 3 seconds of concentric phase (lifting up with the heel) and 3 seconds of eccentric phase (lowering the heel) with 2 seconds of isometric pause (pause at maximum lifted heel). 12 repetitions max (RM) are performed, defined as the maximum (over) weight the patient can lift 12 times with full range of motion while performing the exercise correctly. 3 x 12 exercises are performed per workout. After 2 weeks, the load is while the number of repetitions is reduced to 10 RM with an increase to 4 repetitions per workout. After 4 weeks the intensity is increased to 8RM with 5 set. Patients are instructed to increase the load throughout the training period.
16394193|NCT05064774|Other|myofascial release technique|myofascial release group took myofascial release (MFR) therapy sessions twice a week for 4 weeks between 4 and 7 weeks. MFR was applied to upper trapezius, SCM, pectoralis major-minor and sternocostal fascia. muscle was replaced elongated position and pressure was applied for 60-120 second.
16394194|NCT05064774|Other|physiotherapy|patients used sling up to 4 weeks. They did first 4 weeks passive/ assistive range of motion exercise. In 6-8 weeks they did active exercises. 8-12 weeks they did progressive resistive exercises.
16394195|NCT05063539|Drug|LY3372689|given orally
16394196|NCT05063539|Drug|LY3372689|given orally
16394197|NCT05063539|Drug|Placebo|given orally
16394198|NCT05063019|Diagnostic Test|MRI|Magnetic resonance imaging and enterography before surgery
16394199|NCT05062278|Drug|Vinblastine|Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).
16394200|NCT05062278|Drug|Hydroxyurea capsules|Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.
16394202|NCT05061095|Other|Assessment Surveys|Patients will complete surveys in three periods. An initial baseline survey, longitudinal assessments completed every 2 weeks over the course of the first three months on study (6 times maximum), and extended assessments that will happen every 3 months after the initial longitudinal period up to 2 years on the study (7 times maximum). Baseline questionnaire will collect demographic and background medical record information. Longitudinal assessments will consist of a BWS questionnaire (patients rate importance of 7 treatment goals), decisional conflict scales, EQ-5D-5L, distress thermometer, and items from PRO-CTCAE. Extended assessments will use same questionnaires as longitudinal assessments.
16394203|NCT05061095|Other|Qualitative Interviews|Patients will participate in 2 interviews (1 initial interview, 1 follow up). These will be cognitive interviews focusing on establishing content validity for BWS questionnaire. Will establish patient understanding of questions asked in BWS, understanding of how preferences affect treatment decisions, expected outcomes, and feedback from patients on other potentially important attributes not included in BWS.
16394204|NCT05059899|Behavioral|Exercise group|The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator.
16394205|NCT05059873|Drug|Prednisone|Oral prednisone 40mg/day for five consecutive days
16394206|NCT05059873|Drug|Placebo|Oral placebo of 40mg/day for five consecutive days
16394207|NCT05056376|Behavioral|Digital Diabetes Prevention Program (dDPP)|"The Sweetch app is a hyper-personalized mobile digital coach that provides users with tailored recommendations to promote healthy lifestyle behaviors (150 minutes per week of physical activity, weight reduction, and healthy eating habits) to reduce the risk of type 2 diabetes.
~The Sweetch app uses self-tracking and multiple evidence-based persuasive eCoaching strategies. The Sweetch artificial intelligence algorithm delivers just-in-time support and/or adapt recommendations based on the user's response. For example, push notifications will be sent when the algorithm detects that the user is potentially available and able to act upon the recommendation, based on various parameters including location, p revious response, calendar availability, and weather, etc."
16394208|NCT05056376|Behavioral|Human Coach-based Diabetes Prevention Program (hDPP)|The Human Coach-Based Diabetes Prevention Program will consist of a CDC recognized lifestyle change program. Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.
16394209|NCT05055830|Drug|The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.|The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws), this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care.
16394210|NCT05054413|Other|Questionnaire Administration|Complete questionnaires
16394248|NCT05034822|Drug|Ruxolitinib cream|Ruxolitinib 1.5% cream applied twice daily.
16394249|NCT05034601|Procedure|ESPB group|A 21-gauge 100-mm needle will be inserted into the fascial layer beneath the iliocostalis, longissimus, and spinalis muscles. A bolus of 0.25% ropivacaine 0.5 ml/kg will be injected into the fascial layer. Contralateral ESPB will be performed similarly.
16394445|NCT04873245|Drug|Semaglutide and Behavioral Program|Participants randomized to this group will receive semaglutide and behavioral therapy.
16394213|NCT05050565|Behavioral|Experiences of stigma and psychological flexibility in chronic pain participants|Chronic pain participants will answer questionnaires at two points in time, two weeks apart. These questionnaires ask about stigma and psychological flexibility, as well as depression, catastrophizing, pain interference, and social adjustment. The data collected is only observational and does not include any intervention.
16394214|NCT05049460|Device|Theta Burst Stimulation|Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.
16394215|NCT05049460|Device|Sham TMS|Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
16394216|NCT05048212|Drug|Nivolumab|Given by IV
16394217|NCT05048212|Drug|Ipilimumab|Given by IV
16394218|NCT05048212|Drug|Cabozantinib|Given by IV
16394219|NCT05048095|Other|AI cancer detection system|The use of AI as a third reader and as a decision support system during consensus meeting
16394220|NCT05046808|Drug|Famitinib Malate Capsules|Famitinib Malate Capsules 10mg single dose
16394221|NCT05046808|Drug|Famitinib Malate Capsules|Famitinib Malate Capsules 15mg single dose
16394222|NCT05046808|Drug|Famitinib Malate Capsules|Famitinib Malate Capsules 20mg single dose
16394223|NCT05046808|Drug|Famitinib Malate Capsules|Famitinib Malate Capsules 10mg*2 single dose
16394224|NCT05046808|Drug|Famitinib Malate Capsules|Famitinib Malate Capsules 25mg single dose
16394225|NCT05046704|Device|peripartum transperineal Ultrasound|The anovaginal distance (AVD) will be measured by transperineal ultrasound ,The distance between the anal edge of the internal sphincter and the probe will then be measured in millimeters The ultrasound assessment of the anal sphincters at rest and during contraction will be performed postnatally using a dynamic 2-dimensional transperineal ultrasound with the patient in a supine position, an empty bladder.
16394226|NCT05046392|Behavioral|Face-to-Face ART Adherence Intervention|All participants will receive a one hour face-to-face session with an adherence coach, based on LifeSteps. The session will cover behavioral skills that are important for maintaining adherence to ART and will explore potential barriers for managing each skill. Cognitive-behavioral therapy, problem solving, and motivational interviewing techniques are used to explore barriers and create health goals.
16394227|NCT05046392|Behavioral|Carium Mobile Health Platform|Participants assigned to the experimental condition will receive access to a mobile health app, called Carium, for 12 months. The app will be used to facilitate continued coaching from the adherence coach. The app incorporates automated medications reminders with interactive adherence coaching via a secure messaging feature. Participants will receive custom medication reminders as push notifications that will ask them to indicate if they have taken their medication or not. This will allow adherence coaches to monitor self-reported adherence in the app. Adherence coaches will use the secure messaging feature to check-in with participants and reach out to participants who appear to be struggling with adherence and offer assistance.
16394228|NCT05045638|Drug|Rosuvastatin|Oral dose
16394229|NCT05045638|Drug|Sotorasib|Oral dose
16394230|NCT05042310|Drug|LY3541860|Administered either IV or SC.
16394231|NCT05042310|Drug|Placebo|Administered either IV or SC.
16394232|NCT05039021|Device|HARMONIC 1100 Shears|HARMONIC 1100 Shears is used for vessel transection according to instructions for use.
16394233|NCT05038787|Drug|LY3473329|Administered orally.
16394234|NCT05038787|Drug|Placebo|Administered orally.
16394237|NCT05036746|Other|No intervention|No intervention
16394250|NCT05034601|Procedure|TPVB group|A 21-gauge 100-mm insulated needle will be inserted into the paravertebral space via an in-plane parasagittal approach. After perforating the costotransverse ligament, 0.25% ropivacaine 0.5 ml/kg will be injected. Anterior movement of the pleura indicated the appropriate spread of the local anesthetics in the paravertebral space. The process will be repeated on the contralateral side.
16394251|NCT05032794|Other|Unrestricted diet before colonoscopy|Free diet, without restrictions
16394252|NCT05032794|Other|1-day low residue diet|To follow a diet low in residues / fiber. the day before the colonoscopy.
16394253|NCT05032794|Drug|Bisacodyl 5 MG|If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.
16394254|NCT05028361|Biological|Simultaneous administration of mRNA COVID-19 and IIV4|Subjects will receive an mRNA COVID-19 vaccine either as a study procedure or standard of care and IIV4 on the same day within 8 hours of administration.
16394268|NCT05026788|Other|type of treatment|pathway of management for conservative treatment, operative treatment and type of anaesthesia used
16394269|NCT05024032|Drug|Tirzepatide|Administered SC
16394270|NCT05024032|Drug|Placebo|Administered SC
16394271|NCT05023980|Drug|Pirtobrutinib|Oral
16394272|NCT05023980|Drug|Bendamustine|IV
16394273|NCT05023980|Drug|Rituximab|IV
16394274|NCT05017662|Other|Data collection|Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
16394277|NCT05017545|Biological|carfilzomib|"Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.
~Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant."
16394278|NCT05017545|Biological|belatacept|Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.
16394279|NCT05017545|Procedure|Bone marrow aspiration|Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.
16394280|NCT05017415|Device|uroflow measurement|Non-invasive urodynamic measurement wireless uroflowmeter UROCAP™ IV, Goby System Laborie
16394281|NCT05017415|Device|Bladder ultrasound|Ultrasound of post void residual urine bladderscan CUBEscan BioCon 700
16394282|NCT05016284|Other|JW-100|Cosmetic CBD cream (JW-100)
16394283|NCT05016284|Drug|Eucrisa|Topical EUCRISA®, Pfizer
16394284|NCT05014282|Drug|Nicotine patch|Participants will be provided with a 10-week supply of nicotine patches
16394285|NCT05014282|Behavioral|Counseling|Phone counseling with the Florida Quitline
16394286|NCT05014282|Drug|Nicotine lozenge|Participants will be provided with a 10-week supply of nicotine lozenges
16394287|NCT05014282|Behavioral|Smartphone-delivered automated treatment|An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant
16394288|NCT05012943|Biological|ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine|ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine
16394289|NCT05012943|Other|Placebo (normal saline)|Normal saline with the same volume as of ARCT-154
16394291|NCT05010629|Drug|9-ING-41|Intravenous infusion
16394292|NCT05010629|Drug|Carboplatin|Intravenous infusion
16394403|NCT04931563|Drug|placebo|Intravenous infusion (IV)
16394446|NCT04872101|Drug|Delgocitinib cream|Cream for topical application
16394297|NCT05006144|Other|sequenced trunk co-activation exercises|"Sequenced trunk co-activation exercises were basically used for facilitation of functional activities through trunk musculature dynamic co-activation of in the lateral plane which is required for basic developmental milestones. In the frontal plane, encourage the child to actively shift his/her weight to maintain the weight-bearing side straight while keeping proper active co-activation of trunk musculature. Efficient trunk rotation is essential for acquiring of equilibrium reactions and balance. Enhancement of efficient active trunk rotation as the child could achieve active trunk musculature co-activation while maintaining the weight-bearing side straight (Arndt et al., 2008).
~Righting and protective reactions
~Functional stretching exercises."
16394298|NCT05006144|Other|Standard Orthotic Management|A custom-made articulating ankle foot orthosis with a hinge at the level of the medial malleolus of the ankle is fabricated for each child from the same copolymer thermoplastic mold after casting with the subtalar joint in neutral position. The orthosis extended distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured to the foot by three straps across the forefoot, the front of the ankle, and to the anterior upper tibial portion. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day in the third and fourth months to accommodate children to the orthosis.
16394299|NCT05006144|Other|selective dorsal rhizotomy|All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact. After opening the dura, the posterior nerve roots of L2 to S1 were identified and divided into 3 to 6 rootlets. At L2, from 30% to 50% of the posterior nerve rootlets were sectioned without selective stimulation. Selective electric stimulation of each nerve rootlet was performed from L3 to S1. The percentage of rootlets sectioned at each level (table 3) was determined by the surgical team based on the electromyographic results obtained intrasurgically and knowledge of the presurgical assessment results. The laminae were replaced on the completion of the rootlet stimulation and secured with sutures in the yellow ligament and the supraspinous ligament.
16394300|NCT05004727|Drug|Guselkumab|Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
16394301|NCT05004727|Drug|Placebo|• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).
16394305|NCT04999852|Other|Safe and Sound Protocol|5 hours of filtered and processed music designed to promote efficient regulation of autonomic state
16394306|NCT04999085|Other|Supportive care interventions|Subjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria).
16394307|NCT04997239|Biological|Two doses of quadrivalent influenza vaccine|15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
16394308|NCT04997239|Biological|One dose of quadrivalent influenza vaccine|15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
16394309|NCT04997174|Drug|Celecoxib|Patients in ERAS group received celecoxib
16394310|NCT04997044|Other|Concomitant physical rehabilitation|Children of this group will receive a regular exercise rehabilitation program. Exercises are prescribed on an individual basis per the functional goal for each child. It primarily focuses on inhibition of abnormal movement patterns, enhancement of postural reactions, promotion of the development of postural mechanisms, building up a normal walking pattern, and preservation of the flexibility and functional joint mobility. Neurodevelopmental training, balance training, functional training, range of motion exercises and functional stretching exercises are basically used to achieve the goals. The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and four successive months.
16394404|NCT04929249|Drug|Inclisiran|284 mg liquid in prefilled syringe (PFS), 1.5 ml inclisiran sodium (300 mg)
16394311|NCT04997044|Other|Standard Orthotic Management|A custom-made articulating ankle foot orthosis with a hinge at the level of the medial malleolus of the ankle is fabricated for each child from the same copolymer thermoplastic mold after casting with the subtalar joint in neutral position. The orthosis extended distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured to the foot by three straps across the forefoot, the front of the ankle, and to the anterior upper tibial portion. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day in the third and fourth months to accommodate children to the orthosis.
16394312|NCT04997044|Other|selective dorsal rhizotomy|All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact. After opening the dura, the posterior nerve roots of L2 to S1 were identified and divided into 3 to 6 rootlets. At L2, from 30% to 50% of the posterior nerve rootlets were sectioned without selective stimulation. Selective electric stimulation of each nerve rootlet was performed from L3 to S1. The percentage of rootlets sectioned at each level (table 3) was determined by the surgical team based on the electromyographic results obtained intrasurgically and knowledge of the presurgical assessment results. The laminae were replaced on the completion of the rootlet stimulation and secured with sutures in the yellow ligament and the supraspinous ligament.
16394313|NCT04995029|Drug|Transmucosal Buprenorphine|Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
16394314|NCT04995029|Drug|Extended-release Buprenorphine|Administered by subcutaneous injection
16394317|NCT04992312|Drug|Glucagon Nasal Powder [Baqsimi]|Administered intranasally
16394318|NCT04992273|Drug|casirivimab and imdevimab|Single dose administered based on weight
16394319|NCT04988867|Drug|Trofinetide|Trofinetide solution of 10-30 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)
16394323|NCT04985604|Drug|DAY101|DAY101 tablet for oral use. Other names: TAK580, MLN2480
16394326|NCT04981834|Other|Quality-of-Life Assessment|Ancillary studies
16394327|NCT04981834|Other|Questionnaire Administration|Ancillary studies
16394328|NCT04981834|Procedure|Radical Prostatectomy|Undergo RARP
16394329|NCT04981834|Procedure|Vesicopexy|Undergo vesicopexy
16394330|NCT04981509|Biological|Atezolizumab|Given PO
16394331|NCT04981509|Biological|Bevacizumab|Given IV
16394332|NCT04981509|Drug|Erlotinib|Given PO
16394333|NCT04980157|Behavioral|CARES-HCV|CARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area.
16394336|NCT04976387|Drug|Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET|Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
16394337|NCT04976387|Drug|Ibuprofen 600 mg|Patients will take ibuprofen 600 mg every 6 hours as needed
16394338|NCT04976387|Drug|Acetaminophen 650 MG|Patients will take Tylenol 650mg every 6 hours as needed
16394339|NCT04974996|Drug|Loncastuximab tesirine|Intravenous (IV) infusion
16394340|NCT04974996|Drug|Prednisone|Orally via tablet or capsule
16394341|NCT04974996|Drug|Rituximab|Intravenous (IV) infusion
16394342|NCT04974996|Drug|Cyclophosphamide|Intravenous (IV) infusion
16394343|NCT04974996|Drug|Doxorubicin|Intravenous (IV) infusion
16394344|NCT04974996|Drug|Vincristine|Intravenous (IV) infusion
16394345|NCT04973566|Drug|Nipocalimab|Nipocalimab will be administered as an IV infusion.
16394346|NCT04973566|Drug|Etanercept|Etanercept will be administered subcutaneously.
16394347|NCT04973566|Drug|Hydroxychloroquine|HCQ will be administered orally.
16394348|NCT04973137|Drug|Birtamimab|Intravenous administration of 24 mg/kg birtamimab every 28 days
16394349|NCT04973137|Other|Placebo|Intravenous 0.9% Saline administration as a placebo every 28 days
16394350|NCT04973137|Drug|Standard of Care Chemotherapy|Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care
16394351|NCT04972682|Procedure|Laparoscopic hysterectomy with sentinel lymph node biopsy|Patients will undergo a laparoscopic hysterectomy and sentinel lymph node (SLN) biopsy performed with near-infrared-guided surgery using indocyanine green (ICG). The standard dilution of the drug is 2.5 mg/mL. One milliliter of the diluted drug will be injected into the cervix at 3 and 9 o'clock (total dose - 5 mg) to a depth of 5-10 mm immediately after the onset of anesthesia. Then diagnostic laparoscopy and revision of the abdomen and pelvis will be performed and Image 1S equipment (KARL STORZ©, Tuttlingen, Germany) will be used for this procedure. After revision, fluorescence in the near-infrared spectrum will be determined. Mapping is considered successful when the lymphatic ducts with at least one lymph node are identified. Then the detected SLN will be harvested and total hysterectomy will be performed. Urgent histological examination of the SLN is optional but can be performed at the discretion of the surgeon. If metastasis is detected in the SLN, lymphadenectomy is allowed.
16394489|NCT04840914|Drug|LY3461767|Administered SC.
16394353|NCT04964050|Drug|Capozide|Capozide will be administered as per the treatment sequence.
16394354|NCT04964050|Drug|ACE-Hemmer-Ratiopharm|ACE-Hemmer-Ratiopharm will be administered as per the treatment sequence.
16394355|NCT04961164|Dietary Supplement|Resistant Potato Starch, Corn Starch|Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
16394356|NCT04961164|Dietary Supplement|Corn Starch, Resistant Potato Starch|Consume corn starch at study period 1, then consume resistant starch at study period 2.
16394357|NCT04960124|Drug|JNJ-42847922|Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.
16394358|NCT04958018|Dietary Supplement|Almonds|almond (Prunus dulcis) consumption
16394359|NCT04958018|Dietary Supplement|Snack bars|324 calories/day, Nutri-Grain cereal bars, 120 kcal each
16394360|NCT04957602|Other|Blood collection|Blood collection (4*10ml) before treatment initiation and after the first evaluation (usually 3-4 months after treatment initiation).
16394361|NCT04951609|Drug|Seltorexant|Participants will receive a single oral dose of seltorexant.
16394362|NCT04951609|Drug|Placebo|Participants will receive matching placebo orally.
16394363|NCT04951453|Other|None (observational)|None (observational)
16394364|NCT04951154|Other|Bronchoscopic Biopsy|Bronchoscopic biopsies will be used to evaluate biomarkers of tumor biology and immunology.
16394365|NCT04951154|Other|Blood Sample|Blood samples will be obtained to measure circulating biomarkers.
16394368|NCT04949633|Drug|Prostaglandins|Second cervical ripening lasting a maximum of 24 hours
16394369|NCT04949633|Drug|Oxytocin|Induction of labor with oxytocin.
16394372|NCT04941430|Diagnostic Test|Magnetic Resonance Imaging using 7 Tesla MRI|Undergo 7T MRI
16394373|NCT04941287|Biological|Atezolizumab|Given IV
16394374|NCT04941287|Drug|Cobimetinib|Given PO
16394375|NCT04941287|Drug|Varlilumab|Given IV
16394377|NCT04940039|Drug|Risperidone 3 mg|Participants will receive 3 mg oral risperidone tablet once daily for 3 days.
16394378|NCT04940039|Drug|Paliperidone Palmitate 50 mg eq.|Participants will receive 50 mg eq. PP1M IM injection for at least 17 weeks (maximum 25 weeks).
16394379|NCT04940039|Drug|Paliperidone Palmitate 75 mg eq.|Participants will receive 75 mg eq. PP1M IM injection for at least 17 weeks.
16394380|NCT04940039|Drug|Paliperidone Palmitate 100 mg eq.|Participants will receive 100 mg eq. PP1M IM injection for at least 17 weeks.
16394381|NCT04940039|Drug|Paliperidone Palmitate 150 mg eq.|Participants will receive 150 mg eq. PP1M IM injection for at least 17 weeks.
16394382|NCT04940039|Drug|Paliperidone Palmitate 175 mg eq.|Participants will receive 175 mg eq. PP3M IM injection up to 24 weeks.
16394383|NCT04940039|Drug|Paliperidone Palmitate 263 mg eq.|Participants will receive 263 mg eq. PP3M IM injection up to 24 weeks.
16394384|NCT04940039|Drug|Paliperidone Palmitate 350 mg eq.|Participants will receive 350 mg eq. PP3M IM injection up to 24 weeks.
16394385|NCT04940039|Drug|Paliperidone Palmitate 525 mg eq.|Participants will receive 525 mg eq. PP3M IM injection up to 24 weeks.
16394386|NCT04936035|Drug|Placebo|Placebo administered by SC injection
16394387|NCT04936035|Drug|ALN-AGT01|ALN-AGT01 administered by SC injection
16394388|NCT04934891|Drug|ION547|ION547 will be administered by SC injection.
16394389|NCT04934891|Drug|Placebo|ION547-matching placebo will be administered by SC injection.
16394402|NCT04931563|Biological|Anifrolumab|Intravenous infusion (IV)
16394406|NCT04926220|Device|Trans-esophageal Doppler monitoring|Trans-esophageal Doppler monitoring (CARDIOQ-ODM; Deltex Medical, Chichester, UK) for monitoring of cardiac output
16394407|NCT04926220|Device|MostCareUP Haemodynamic Monitor|MostCareUp (Vytech, Padova, Italy) waveform analysis cardiac output monitor
16394408|NCT04926220|Device|Argos Cardiac Output (CO) Monitor|Argos monitor (Retia Medical, Valhalla, NY, USA) for cardiac output monitoring
16394409|NCT04924374|Dietary Supplement|Microbiota Transplant plus anti PD1 therapy|"Pooled fecal microbiota capsules of 1 donor selected based on their fecal abundance in Faecalibacterium prausnitzii, Bifidobacterium longum, Akkermansia muciniphila and Fusobacterium spp. after screening and metagenomic analysis of 10 donors with high-fiber diets (>30g/day).
~anti PD1 therapy every 2-3 weeks"
16394410|NCT04924374|Drug|anti PD1 therapy|anti PD1 therapy every 2-3 weeks
16394411|NCT04920578|Drug|JNJ-69095897|JNJ-69095897 will be administered orally in Parts 1, 2 and 3.
16394412|NCT04920578|Other|Placebo|Matching placebo will be administered orally in Parts 1 and 3.
16394413|NCT04917120|Device|Virtual Reality|The procedure will consist of a virtual reality program associated with suggestions of hypnoanalgesia, be added to usual care. Included patients will benefit from the Virtual Reality program combined with hypnoanalgesia suggestions for a period of 20 minutes. We will use a helmet with a built-in screen and an audio headset connected to a control room. Patients will watch an Virtual Reality sequence while listening to narratives designed for the hypnoanalgesia of the present pain.
16394414|NCT04916600|Device|NET|NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
16394417|NCT04912505|Drug|Aspirin|Run-in phase during one week with daily aspirin intake at 8 AM; visit 1: blood sampling at H24 and H2; intermediate phase (two weeks): daily aspirin intake at 8 PM; visit 2: blood sampling at H12; then daily intake of aspirin at the time preferred by the patient and study end visit 2 weeks after visit 2
16394418|NCT04911543|Drug|[18F]-JNJ-70099731|[18F]JNJ-70099731 injection will be administered intravenously.
16394419|NCT04911049|Diagnostic Test|Blood Pressure measurement|Blood Pressure measurement
16394420|NCT04908956|Drug|Osimertinib|"Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.
~The appropriate number of osimertinib tablets (80 mg or 40 mg if the dose is reduced due to toxicity) will be provided to patients to be self-administered at home."
16394421|NCT04908956|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT will be delivered using risk-adapted SBRT with a maximum of 5 SBRT fractions.
16394430|NCT04895488|Drug|Vortioxetine|"First treatment phase: vortioxetine will be initiated at 10 mg / day for 2 weeks, followed by 20 mg /day for 22 weeks. The dose of vortioxetine can be lowered to 5 mg or 10 mg for tolerability reasons at clinician criteria.
~Wash-out period 2 weeks"
16394431|NCT04895488|Drug|Usual Antipsychotic Treatment|Second treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
16394432|NCT04893460|Behavioral|CoQuit App|The CoQuit App is a cognitive dissonance based app for smoking cessation.
16394433|NCT04891757|Drug|FHD-286|FHD-286 as a single, orally administered agent.
16394437|NCT04889872|Device|SAPIEN 3 / SAPIEN 3 Ultra|Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra heart valve
16394438|NCT04886791|Procedure|Vaginal NOTES hysterectomy|Vaginal assited NOTES hysterectomy
16394439|NCT04886791|Procedure|Vaginal hysterectomy|Vaginal hysterectomy
16394440|NCT04879017|Drug|FHD-286|FHD-286 as a single agent
16394441|NCT04878172|Device|TempSure Firm|The TempSure firm will be used on the abdomen for non-invasive lipolysis.
16394442|NCT04875975|Drug|Rozanolixizumab|"Pharmaceutical form: Solution for infusion
~Route of administration: Subcutaneous use
~Subjects will receive rozanolixizumab in a pre-specified sequence during the Treatment Period."
16394443|NCT04875975|Drug|Placebo|"Pharmaceutical form: Solution for infusion
~Route of administration: Subcutaneous use
~Subjects will receive placebo in a pre-specified sequence during the Treatment Period."
16394444|NCT04873245|Behavioral|Intensive Behavioral Program|Participants randomized to this group will receive intensive behavioral therapy.
16394490|NCT04840914|Drug|Placebo|Administered SC.
16394447|NCT04872101|Drug|Cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
16394448|NCT04870762|Other|Best Practice|Receive standard of care
16394449|NCT04870762|Device|Medical Device Usage and Evaluation|Wear 3D printed oral stent
16394450|NCT04867785|Drug|LY3437943|Administered SC
16394451|NCT04867785|Drug|Dulaglutide|Administered SC
16394452|NCT04867785|Drug|Placebo|Administered SC
16394455|NCT04864834|Biological|SOK583A1 (40 mg/mL)|IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
16394456|NCT04864834|Biological|Eylea EU (40 mg/mL)|IVT administration of 2 mg of Eylea in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
16394457|NCT04862897|Other|Patient-controlled admissions|Patients are allowed to admit themselves to inpatient care when needed (standard procedure, four days of inpatient care at a time, up to three times a month)
16394458|NCT04861597|Behavioral|Internet based cognitive behavioral therapy|Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
16394459|NCT04861597|Behavioral|Digital mood tracking|Participants with elevated psychological distress will receive 8 weeks of digital mood tracking
16394460|NCT04857307|Drug|Alprazolam|"Pharmaceutical form: Inhalation powder.
~Study participants will receive Staccato alprazolam at prespecified time-points."
16394461|NCT04856826|Device|ultrasound guidance and therapeutic communication|insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication
16394462|NCT04853017|Drug|ELI-002 2P|Amph-CpG-7909 admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
16394463|NCT04852302|Behavioral|CALM Therapy|The CALM intervention is a brief, individualized psychotherapeutic intervention established to meet an unmet need to address psychological distress and promote well-being in advanced cancer patients.
16394464|NCT04847557|Drug|Tirzepatide|Administered SC
16394465|NCT04847557|Other|Placebo|Administered SC
16394469|NCT04847453|Procedure|Bone Marrow Aspiration and Biopsy|Undergo bone marrow aspiration and biopsy
16394470|NCT04847453|Drug|Dexamethasone|Given PO
16394471|NCT04847453|Drug|Ixazomib Citrate|Given PO
16394472|NCT04847453|Drug|Venetoclax|Given PO
16394480|NCT04846530|Device|RHA® 1, RHA® 2, RHA® 3, and RHA® 4|For each subject, two spaced boluses (0.2 mL each) of the product will be implanted on the same side (left or right side) in the post auricular area of the subject per treatment assignment. The assignment will specify one of the RHA® products to the left ear and another product to the right ear. Each subject will have a total of four boluses.
16394481|NCT04844606|Drug|Mirikizumab|Administered SC
16394482|NCT04844424|Drug|Milvexian|Milvexian will be administered orally as tablets or capsules.
16394483|NCT04844411|Drug|JNJ-67835989|JNJ-67835989 will be administered orally.
16394484|NCT04844411|Drug|Placebo|Matching placebo will be administered orally.
16394485|NCT04843852|Drug|Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]|one 0.5ml intramuscular injection on day 0 and week 4.
16394486|NCT04841057|Procedure|50 cm BP limb length|50 cm biliopancreatic limb length
16394487|NCT04841057|Procedure|100 cm BP limb length|100 cm biliopancreatic limb length
16394488|NCT04841057|Procedure|150 cm BP limb length|150 cm BP limb length
16394491|NCT04838795|Biological|To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine|To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa
16394492|NCT04838769|Device|REZŪM|Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
16394493|NCT04838769|Drug|alpha blocker and 5-alpha reductase inhibitor|Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care.
16394494|NCT04838613|Drug|[18F]CTT1057|Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan
16394495|NCT04838613|Drug|[68Ga]Ga-PSMA-11|Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan
16394496|NCT04836559|Drug|JNJ-40411813|JNJ-40411813 will be administered orally.
16394497|NCT04836559|Drug|Placebo|Placebo will be administered orally.
16394498|NCT04836390|Device|Haploidentical IL-21-Expanded Natural Killer Cells|Peripheral blood (PB) ≤ 450 mL and based on donor weight (minimum 10 ml/kg) will be drawn from the HLA-haploidentical donor at least 16 days before the scheduled day of transplant (Day 0). HaploNK cells will be manufactured from the PB of the donor after co-culture with irradiated feeder cells (IFC) as described in Section 2.4. The recipients will receive three NK cell infusions on Day-1, Day+7 (± 1 day) and Day+42 (up to Day+90) from day of transplant (Day 0).
16394499|NCT04835272|Procedure|the Decannulation Protocol With Suctioning|In the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials.
16394500|NCT04831554|Procedure|single chest tube drainage|place single chest tube after surgery of PSP
16394501|NCT04830735|Drug|Dasatinib Anhydrous|Given PO
16394502|NCT04830735|Drug|Placebo Administration|Given PO
16394503|NCT04829318|Drug|Esketamine|Esketamine will be self-administered as nasal spray.
16394504|NCT04829318|Drug|SSRI/SNRI|Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the summary of product characteristics (SmPC) (or local equivalent, if applicable). During this LTE study, investigators will be allowed to switch individual participant's SSRI/SNRI for tolerability issues.
16394505|NCT04827576|Drug|Magrolimab|Administered intravenously
16394506|NCT04827576|Drug|Docetaxel|Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
16394507|NCT04821531|Other|PT Pal|Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength balance and mobility
16394508|NCT04821531|Other|Exercise Manual|Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength, balance and mobility
16394509|NCT04820530|Drug|Iptacopan (LNP023)|Taken orally b.i.d. Dosage supplied: 200mg Dosage form: Hard gelatin capsule Route of Administration: oral
16394510|NCT04820049|Drug|F573|F573 for injection
16394511|NCT04820049|Other|Placebo|Water for injection
16394512|NCT04817618|Drug|Placebo|Placebo to iptacopan 200mg b.i.d.
16394513|NCT04817618|Drug|iptacopan|iptacopan 200mg b.i.d.
16394518|NCT04817241|Procedure|Biopsy of Bone|Undergo bone biopsy
16394519|NCT04817241|Drug|Cytarabine|Given IV
16394520|NCT04817241|Drug|Daunorubicin|Given IV
16394521|NCT04817241|Drug|Decitabine and Cedazuridine|Given PO
16394522|NCT04817241|Drug|Venetoclax|Given PO
16394523|NCT04816734|Other|Self-report questionnaires|"Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition.
~The assessment takes place after the parents have participated in the therapeutic education program and before their child returns home."
16394525|NCT04814862|Behavioral|3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disorders|Completion of three validated questionnaires for the diagnosis of neurodevelopmental disorders
16394526|NCT04814472|Drug|BLD-0409|Randomized to active product.
16394527|NCT04811248|Other|telephone call for parents of patients|telephone call for parents of patients aged 6 years old
16394529|NCT04807842|Device|vaginal gel|The placebo gel is a non-buffered gel. The active device is an acidic gel.
16394530|NCT04800692|Drug|Tetrahydrobiopterin 10 mg/kg|10mg/kg of Tetrahydrobiopterin daily.
16394531|NCT04800692|Drug|Tetrahydrobiopterin 20 mg/kg|20mg/kg of Tetrahydrobiopterin daily.
16394532|NCT04800692|Drug|L-Ascorbate|3300 mg of l-ascorbate once daily
16394533|NCT04800692|Drug|L-Arginine|3400mg of l-arginine once daily
16394534|NCT04800237|Drug|VQW-765|oral capsule
16394535|NCT04800237|Drug|Placebo|oral capsule
16394745|NCT04508023|Other|Placebo|Participants will receive matching placebo tablet orally once daily.
16394541|NCT04791488|Procedure|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy protocol
16394542|NCT04791488|Procedure|Diving simulation|Hyperbaric chamber diving simulation protocol
16394544|NCT04783207|Dietary Supplement|Mitopure|Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
16394545|NCT04783207|Dietary Supplement|Placebo|Softgel containing only excipients. 4 soft-gels to be taken daily
16394547|NCT04781478|Other|Application of Biorepair Gel|Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).
16394548|NCT04781478|Other|Irrigation of Chlorhexidine 1.00% gel|Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).
16394551|NCT04779957|Drug|Tocilizumab|Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.
16394552|NCT04774718|Drug|Alectinib|Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle
16394553|NCT04770805|Procedure|Fetoscopy|After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will consist in a dissection of the placode, its reintegration into the spinal canal and the closure of the lesion, through a three ports access. After fetal surgery, the gas will be exsufflated and the trocar ports will be closed. The uterus will be reintegrated before suturing the maternal abdominal wall.
16394554|NCT04770246|Drug|TAS-117|TAS-117 will be dosed orally every day on a 21-day cycle
16394555|NCT04770246|Drug|TAS-117|TAS-117 will be dosed intermittently on a 21-day cycle
16394556|NCT04770246|Drug|TAS-117|TAS-117 will be dosed orally every day or intermittently on a 21-day cycle
16394557|NCT04770246|Drug|TAS-117|TAS-117 will be dosed orally every day or intermittently on a 21-day cycle
16394558|NCT04764188|Drug|Alectinib|Participants will receive alectinib in accordance with local clinical practice and local labeling.
16394559|NCT04756375|Device|Virtual Reality|Use of virtual reality in the management of sickle cell patients with VOS
16394560|NCT04756375|Other|Usual Care|Usual management of sickle cell patients with VOS
16394561|NCT04752371|Drug|AEVI-007 (CERC-007, AVTX-007)|Intravenous (IV) Infusion
16394562|NCT04752332|Drug|Abemaciclib|Administered orally.
16394563|NCT04752332|Drug|Standard Adjuvant ET|Administered according to label instructions.
16394564|NCT04752332|Drug|Placebo|Administered orally.
16394566|NCT04745026|Drug|GWP42003-P|GWP42003-P oral solution (100 milligrams per milliliter [mg/mL] cannabidiol [CBD] in sesame oil with anhydrous ethanol, ethanol [10% v/v] sweetener [sucralose], and strawberry flavoring), administered twice a day (morning and evening)
16394567|NCT04745026|Drug|Placebo|Oral placebo to match GWP42003-P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)
16394568|NCT04743505|Drug|APL-101|-Provided by Apollomics
16394569|NCT04743505|Drug|Osimertinib|-Given standard of care
16394570|NCT04738825|Behavioral|Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)|"Participants will receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12 will be stepped up to receive PrEP adherence and support services (n=5)."
16394571|NCT04728295|Device|Exablate 4000|Exablate Pallidothalamic Tractotomy
16394572|NCT04725721|Behavioral|FIRST|FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.
16394573|NCT04725721|Behavioral|Usual Care|Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
16394574|NCT04715230|Biological|IXT-m200|IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
16394575|NCT04715230|Drug|Lorazepam|Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
16394576|NCT04715230|Drug|Haloperidol|Haloperidol is commonly used to treat agitation due to psychosis.
16394578|NCT04704661|Drug|Ceralasertib|Given PO
16394579|NCT04704661|Biological|Trastuzumab Deruxtecan|Given IV
16394580|NCT04700527|Drug|Short Chain Fatty Acid|Participants will take the supplement as prescribed to determine if it can help with GI toxicity
16394581|NCT04700527|Drug|Tapioca Flour|Participants taking this will be used as a control group compared to those receiving the SCFA supplement
16394585|NCT04691648|Drug|Gilteritinib Exposure|Oral
16394586|NCT04685759|Other|In-Person Exercise Protocol|Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.
16394587|NCT04685759|Other|Virtual Exercise Protocol|Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes each virtual session. A TheraBand (resistance band) will be provided to patients in this group to be used for resistance and flexibility training.
16394588|NCT04685135|Drug|MRTX849|21 day cycles
16394589|NCT04685135|Drug|Docetaxel|21 day cycles
16394590|NCT04684121|Drug|Granexin® gel (200 μM)|Granexin® gel (200 μM) will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.
16394591|NCT04684121|Drug|Vehicle gel|Vehicle gel will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.
16394592|NCT04672681|Behavioral|Play-based physical activity intervention|The intervention group will participate in a six-month play-based physical activity intervention starting from their initiated treatment. The intervention combines hospital and home-based physical activity. Three days a week, there will be 45 minutes of group-based physical activity at the hospital during admissions or appointments at the outpatient clinic, supervised by an exercise professional or pediatric physiotherapist. Children who are isolated during treatment are offered supervised individual 45 min. training sessions 3 times a week as a substitute. During the other four days a week, or on days where the family is at home, the parents administer the play-based physical activity. At inclusion, the parents receive education and supervision on conducting play-based physical activity with their child in the hospital room or at home. They will receive inspiration material containing numerous different plays, games, and activities in different intensities.
16394593|NCT04665739|Drug|Everolimus|Given PO
16394594|NCT04665739|Drug|Lutetium Lu 177 Dotatate|Given IV
16394595|NCT04665557|Behavioral|Dove Confident Me Indonesia Single Session|"Dove Confident Me Indonesia Single Session is an adaptation of Dove Confident Me Global Single Session, designed to be facilitated by schoolteachers or school counsellors. Dove Confident Me Indonesia includes four interactive activities (to be delivered in a single 90-minute session) as well as a homework challenge and commitment pledge. The programme incorporates three primary techniques to improve Indonesian adolescents' body confidence and self-esteem: (1) psychoeducation, (2) media literacy, and (3) cognitive dissonance as well as two secondary techniques: (4) self-affirmation and (5) cognitive reframing. As the curriculum was adapted to be delivered in Indonesian schools with limited resources, videos or PowerPoint presentations are not included. Instead, a detailed teacher guide and student worksheets are provided.
~Due to COVID-19, the intervention will be delivered online via video conferencing platform."
16394596|NCT04654143|Drug|BVL-GSK098 capsule, placebo|Oral QD
16394597|NCT04652882|Drug|Tasimelteon|oral capsule
16394598|NCT04652882|Drug|Placebo|oral capsule
16394599|NCT04650945|Other|isCGM group|As previously described
16394603|NCT04646395|Drug|Tafasitamab|200 mg powder for reconstitution with 5 ml water for injection
16394604|NCT04646395|Drug|Acalabrutinib|100 mg hard gelatin capsules
16394741|NCT04513912|Drug|Matching placebo to Seltorexant|Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.
16394608|NCT04644315|Drug|Alectinib|Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
16394609|NCT04641312|Drug|LY3457263|Administered SC
16394610|NCT04641312|Drug|Dulaglutide|Administered SC
16394611|NCT04641312|Drug|Placebo|Administered SC
16394618|NCT04639258|Device|Medtronic Evolut™ PRO+ System|TAVR treatment with Medtronic Evolut™ PRO+ System
16394619|NCT04634253|Drug|Placebo|Given IV
16394620|NCT04634253|Drug|LY3462817|Given IV
16394623|NCT04630925|Other|isCGM|As previously described
16394624|NCT04626297|Drug|Lebrikizumab|Given SC
16394625|NCT04626297|Drug|Placebo|Given SC
16394626|NCT04624620|Behavioral|Teaching Kitchen Collaborative Curriculum|This is a referral-based teaching kitchen intervention that synergistically provides basic cooking skills, an evidence-based nutrition curriculum, mindfulness skills, activity tracking, and support for behavior change to augment weight management and lifestyle change in the primary care setting.
16394627|NCT04619420|Drug|JNJ-63733657|JNJ-63733657 low or high dose will be administered by IV infusion.
16394628|NCT04619420|Drug|Placebo|Placebo matching to JNJ-63733657 will be administered by IV infusion.
16394630|NCT04616677|Drug|JNJ-42847922|JNJ-42847922 tablet will be administered orally.
16394631|NCT04616326|Drug|Galcanezumab|Administered SQ
16394632|NCT04616326|Drug|Placebo|Administered SQ
16394633|NCT04614324|Device|RhinAer ARC Stylus|The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).
16394634|NCT04608877|Behavioral|Take 5 and Audio Clip|Parent will receive the 5 discrete safety steps for infant crying and listen to the audio clip of infant crying and public service announcement message
16394635|NCT04608877|Behavioral|Take 5 Only|Parent will only receive the 5 discrete safety steps for infant crying
16394636|NCT04605991|Drug|LY900014|Administered SC
16394637|NCT04605991|Drug|Insulin Glargine|Administered SC
16394638|NCT04605380|Other|Virtual reality online world|Virtual patient with open fracture inside a virtual world
16394639|NCT04603898|Dietary Supplement|Low Oxalate Diet|Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 4 days
16394640|NCT04603898|Dietary Supplement|Carbon-13 Ascorbic Acid Oral Load|Subjects will be instructed to ingest 1mg/kg of carbon-13 ascorbic acid at breakfast, 2 days after initiating the low oxalate controlled diet.
16394641|NCT04603651|Drug|Bamlanivimab|Administered intravenously (IV).
16394643|NCT04599855|Drug|Esketamine 56 mg|Esketamine 56 mg will be self administered as nasal spray.
16394644|NCT04599855|Drug|Esketamine 84 mg|Esketamine 84 mg will be self administered as nasal spray.
16394645|NCT04599855|Drug|Placebo|Matching placebo will be self administered as nasal spray.
16394649|NCT04598139|Other|Study group|The study group uses a web-based medication error notification system
16394650|NCT04597359|Drug|Placebo Administration|Given PO
16394651|NCT04597359|Other|Quality-of-Life Assessment|Ancillary studies
16394652|NCT04597359|Other|Questionnaire Administration|Ancillary studies
16394653|NCT04597359|Drug|Sinecatechins|Given PO
16394742|NCT04513912|Drug|Quetiapine XR|Participants will receive quetiapine XR capsule orally.
16394656|NCT04595747|Drug|Rogaratinib|Given PO
16394657|NCT04594408|Drug|Epinephrine|1 mL of 1:1000 mixed into irrigation bag.
16394658|NCT04594408|Drug|Tranexamic acid|1 g IV x 1 dose to be administered intraoperatively.
16394659|NCT04594408|Drug|Epinephrine and Tranexamic Acid|1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.
16394661|NCT04591626|Drug|Dulaglutide|Administered SC
16394662|NCT04591626|Drug|Placebo|Administered SC
16394663|NCT04591626|Drug|Insulin Glargine|Administered SC
16394664|NCT04587245|Other|Online questionnaire and interviews|Online questionnaire, financial statements (one month per quarter in 2020) submitted electronically, interview with professional accounting firm and review of data and exit Interview
16394665|NCT04585724|Drug|Abemaciclib|Given PO
16394666|NCT04585724|Drug|Palbociclib|Given PO
16394667|NCT04585724|Other|Quality-of-Life Assessment|Ancillary studies
16394668|NCT04585724|Drug|Ribociclib|Given PO
16394677|NCT04583072|Diagnostic Test|The Stockholm3 test|Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
16394678|NCT04582617|Dietary Supplement|Cocoa Extract|2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
16394679|NCT04582617|Dietary Supplement|Cocoa Extract Placebo|Cocoa extract placebo
16394680|NCT04582617|Dietary Supplement|Multivitamin|Multivitamin
16394681|NCT04582617|Dietary Supplement|Multivitamin placebo|Multivitamin placebo
16394682|NCT04581824|Drug|Dostarlimab|Dostarlimab will be administered through a 30 minute infusion at a dose of 500 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) up to a maximum of 35 cycles (each cycle of 21 days).
16394683|NCT04581824|Drug|Pembrolizumab|Pembrolizumab will be administered through a 30 minute infusion at a dose of 200 mg Q3W up to a maximum of 35 cycles (each cycle of 21 days).
16394684|NCT04581824|Drug|Chemotherapy|"Pemetrexed will be administered at 500 milligram per meter square (mg/m^2 ) IV through a 10 minute IV infusion Q3W, up to a maximum of 35 cycles (each cycle of 21 days).
~Cisplatin will be administered at 75 mg/m^2 through a 30 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.
~Carboplatin will also be administered at area under the concentration time curve 5 milligram/milliliters/minute (mg/mL/min) (maximum dose: 750 mg) through a 15 to 60 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision."
16394685|NCT04578834|Drug|Placebo|Placebo to LNP023 200mg b.i.d
16394686|NCT04578834|Drug|LNP023|LNP023 200mg b.i.d
16394687|NCT04571697|Drug|Methotrexate|No intervention or treatment will be administered as part of this study. Data of participants with first claim for a methotrexate in the patient's history are included.
16394688|NCT04571697|Drug|Anti-TNF|No intervention or treatment will be administered as part of this study. Data of participants with first claim for an anti-TNF in the patient's history are included. Anti-TNF includes infliximab, golimumab, etanercept, certolizumab, and adalimumab.
16394689|NCT04569695|Drug|JNJ-70033093|JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
16394691|NCT04568434|Drug|AKCEA-APOCIII-LRx|AKCEA-APOCIII-LRx will be administered by SC injection.
16394692|NCT04568434|Drug|Placebo|AKCEA-APOCIII-LRx-matching placebo will be administered by SC injection.
16394693|NCT04566185|Other|FDG PET|"IV application of F Dopa, 2 MBq per Kg, with a scout view (angle of view 90 °, 120 kV, 30 mAs), then an X-ray scan is performed for the attenuation correction ( 120 kV - 5mAs - pitch 0.531 - thickness // increment: 3.75mm//3.27mm -QAC filter - DFOV 25).
~PET acquisition: static in 3D mode for 20 minutes, 8 minutes after the injection of 18 F Dopa, the axial field of view is 25, the matrix in 256 x 256. After OSEM reconstruction 6 iterations and 24 subsets, with correction of attenuation and diffusion, then Gaussian filter of frequency 4, 47 contiguous axial sections of 3.26 mm are obtained."
16394743|NCT04513912|Drug|Matching placebo to Quetiapine XR|Participants will receive placebo capsule matching to quetiapine XR orally.
16394694|NCT04566185|Other|CT scan|"Localization propeller without injection: 120kV - mA regulation (Noise Index 15) - pitch 0.969 - thickness // increment: 5mm // 5mm - Soft filter - Asir 60% - DFOV 25.
~Acquisition begins 5 seconds after the start of the injection of 60 ml of contrast product (VISIPAQUE) at 4 cc / second without (acquisition characteristics: 80 kV - 100 mAs -- thickness: 5mm // 8 images / rotation - STD filter - Asir 50% display field of view (DFOV) 25 - phase1: 5s then phase2 15s).
~Diagnostic quality CT: 120kV - Regulation of mA (Noise Index 15) - pitch 0.531 - thickness // increment: 1.25 // 0.625mm - Soft filter - Asir 60% - DFOV 25."
16394695|NCT04566185|Other|Magnetic resonance imaging (MRI)|"If the examination is performed on the SIEMENS SKYRA 3T device: 32 channel head coil antenna, if on the PHILIPPS INGENIA 1.5 T device: DStream HeadSpine Coil antenna.
~The sequence begins with an axial, coronal and sagittal Survey topogram, lasting 1 minute.
~Then axial sequence T1, Axial T2 *, Axial cerebral perfusion (Injection of gadolinium (0.1 mmol / kg, 5 cc / second), coronal T2, Axial T2 Flair, Axial DWI b100, Axial 3D T1 gadolinium"
16394698|NCT04566029|Biological|Blood test|The patients' blood will be collected in four 5mL heparinized tubes
16394699|NCT04566029|Biological|Stool sample|The patients' stools will be collected at home
16394700|NCT04566029|Other|Questionnaires|At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE
16394701|NCT04565717|Drug|ALN-HSD|ALN-HSD will be administered by subcutaneous (SC) injection.
16394702|NCT04565717|Drug|Placebo|Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
16394703|NCT04565249|Drug|PLN-74809|PLN-74809
16394704|NCT04565249|Drug|Placebo|Placebo
16394705|NCT04562363|Procedure|Suturing of a laparotomic wound with modified methods|Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
16394710|NCT04551131|Drug|Ruxolitinib|Given orally (PO) or per nasogastric tube (NGT) twice a day for 8 weeks
16394711|NCT04551131|Drug|Dexamethasone|Given intravenously (IV) or orally (PO) twice a day for 8 weeks
16394712|NCT04551131|Drug|Etoposide|Given intravenously (IV) once a week for 8 weeks
16394713|NCT04551066|Drug|parsaclisib|parsaclisib will be administered QD orally
16394714|NCT04551066|Drug|ruxolitinib|ruxolitinib will be administered BID orally
16394715|NCT04551066|Drug|placebo|placebo will be administered QD orally
16394721|NCT04547712|Device|Adaptive DBS|Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
16394722|NCT04539366|Drug|Cyclophosphamide|Given IV
16394723|NCT04539366|Drug|Fludarabine Phosphate|Given IV
16394724|NCT04539366|Biological|GD2-CAR-expressing Autologous T-lymphocytes|Given IV
16394727|NCT04533529|Drug|Seltorexant|Seltorexant tablet will be administered orally once daily.
16394728|NCT04533529|Drug|Placebo|Matching placebo tablet will be administered orally once daily.
16394729|NCT04532749|Drug|Seltorexant|Participants will receive Seltorexant tablets.
16394730|NCT04532749|Drug|Placebo|Participants will receive matching placebo tablets.
16394731|NCT04531982|Drug|Pimavanserin|Pimavanserin 34 mg, taken as two blinded 17 mg tablets once daily by mouth
16394732|NCT04531982|Drug|Placebo|Placebo, taken as two blinded tablets once daily by mouth
16394733|NCT04527380|Drug|Ixekizumab|Administered SC
16394734|NCT04527380|Drug|Adalimumab|Administered SC
16394735|NCT04522089|Biological|AdimrSC-2f|AdimrSC-2f is a candidate vaccine against COVID-19 developed by Adimmune Corporation (Adimmune). Using the baculovirus-insect cells expression system, the recombinant receptor binding domain (RBD) of SARS-CoV-2 spike (S) protein is amplified and purified. AdimrSC-2f is formulated in the different dosages of Spike (S) protein without/with aluminum content as adjuvant.
16394736|NCT04516564|Drug|AK119|Single dose of AK119 is administered via intravenous infusion to healthy subjects
16394737|NCT04516564|Drug|Placebo|Single dose of placebo is administered via intravenous infusion to healthy subjects
16394738|NCT04514510|Drug|Isoquercetin|Isoquercetin (quercetin-3-O-D-glucoside, also referred to as isoquercitrin) is a naturally occurring monoglucoside of the most studied and widely consumed bioflavonoid, quercetin.
16394739|NCT04514510|Drug|Placebo|Silicified microcrystalline cellulose NF, Ascorbic acid, Nicotinic acid, Mg stearate, Silica and Colloidal Anhydrous Ph. Eur./Colloidal Silicon dioxide USP/NF
16394740|NCT04513912|Drug|Seltorexant|Participants will receive seltorexant over-encapsulated tablet orally.
16394836|NCT04357457|Drug|Placebo|Intravenous glucose 5% during 5 days
16394746|NCT04508023|Other|Standard of Care (SOC)|SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
16394747|NCT04504435|Drug|GSK3494245|Capsule of 10-250 mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
16394748|NCT04504435|Drug|Placebo|Matching placebo capsules will be provided
16394749|NCT04498910|Drug|LY3451838|Administered IV
16394750|NCT04498910|Drug|Placebo|Administered IV
16394751|NCT04498754|Behavioral|Cognitive Behavior Therapy for Insomnia|8 sessions of treatment for insomnia.
16394752|NCT04498754|Behavioral|Weekly phone contacts|Weekly calls to monitor insomnia symptoms.
16394753|NCT04494360|Other|No intervention|No investigational medicinal product will be administered as a part of this study.
16394754|NCT04493502|Drug|Placebo|Given IV
16394755|NCT04493502|Drug|LY3041658|Given IV
16394756|NCT04476446|Drug|Esketamine|Participants will receive esketamine at doses of either 56 mg or 84 mg intranasally once or twice a week based on the investigator's clinical judgment.
16394757|NCT04470882|Behavioral|Exposure with faded safety behaviors|Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during the first two trials, and will remove the protective gear during the last trial.
16394758|NCT04470882|Behavioral|Exposure without safety behaviors|Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will not wear protective gear during any of the exposure therapy trials.
16394759|NCT04470882|Behavioral|Exposure with unfaded safety behaviors|Exposure therapy will involve three, 10-minute trials in which participants encounter a spider. Participants in this group will wear protective gear during all three exposure therapy trials.
16394760|NCT04469101|Procedure|Lumbar Epidural|Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.
16394764|NCT04467515|Drug|CAM-H2|All patients will receive at least 1 cycle of CAM-H2. Patients with CB may receive 2 cycles of CAM-H2, each cycle given as 2 IV administrations, 4 weeks apart.
16394765|NCT04463108|Other|No Intervention|No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
16394766|NCT04458987|Behavioral|Expert patient in addictology|"EP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients.
~The content of the intervention will be defined trough the results of step one of the study."
16394767|NCT04456673|Drug|Dupilumab SAR231893|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16394768|NCT04456673|Drug|Inhaled Corticosteroid|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16394769|NCT04456673|Drug|Inhaled Long-Acting Beta Agonist|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16394770|NCT04456673|Drug|Inhaled Long-Acting Muscarinic Antagonist|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16394771|NCT04456673|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16394772|NCT04455100|Drug|SHR1459/Itraconazole|SHR1459 will be administered on Day 1 and Day 7. Itraconazole will be administered on Day 4 to Day 8
16394773|NCT04451954|Biological|Quadrivalent RIV with H3 strain 1|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394774|NCT04451954|Biological|Quadrivalent RIV with H3 strain 1 and adjuvant|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394775|NCT04451954|Biological|Quadrivalent RIV with H3 strain 2|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394776|NCT04451954|Biological|Quadrivalent RIV with H3 strain 2 and adjuvant|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394777|NCT04451954|Biological|Quadrivalent RIV with 2018-2019 NH H3 strain|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394778|NCT04451954|Biological|Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
16394779|NCT04451187|Drug|Seltorexant Dose 1|Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
16394780|NCT04451187|Drug|Seltorexant Dose 2|Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
16394781|NCT04451187|Drug|Placebo|Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
16394782|NCT04451187|Drug|Zopiclone|Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
16394783|NCT04439578|Drug|SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin|600 mg rifampicin was administered in the morning.
16394784|NCT04439266|Drug|Crizotinib|Given PO
16394785|NCT04439149|Drug|PI3K-beta Inhibitor GSK2636771|Given PO
16394786|NCT04437511|Drug|Donanemab|Given IV
16394787|NCT04437511|Drug|Placebo|Given IV
16394788|NCT04431219|Biological|LIS1|LIS1 is an induction treatment on top of maintenance immunosuppressive regimen. All patients from AD and TD cohort will receive the conventional immunosuppressive regimen: tacrolimus (0.2 mg/kg) / mycophenolic acid (MMF, 2x1000 mg) / prednisone (20 mg from day 2). This conventional treatment should be started and monitored for all patients independently of their participation in the clinical trial. Methylprednisolone 500 mg / 100 mL saline / 30 minutes will be administered before reperfusion during the surgery and on post operation day 1 just before LIS1 administration.
16394789|NCT04430517|Drug|Nicotinamide riboside|Participants will take 4 pills every day, each containing 250 mg NR (NIAGEN® by Chromadex; www.chromadex.com), via the oral route, for 12 weeks.
16394790|NCT04423601|Drug|SHR6390 tablet|single oral dose of SHR6390 or co-administered with itraconazole.
16394791|NCT04423601|Drug|Itraconazole capsule|200 mg itraconazole was administered in the morning.
16394792|NCT04418141|Drug|CN1|Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). The 5 planned dose levels are 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg.
16394797|NCT04413318|Device|Electronic device (VBM©)|Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.
16394798|NCT04413318|Device|Pneumatic device (Nosten©)|Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
16394800|NCT04408924|Drug|Abemaciclib|Administered orally
16394801|NCT04408638|Drug|Obinutuzumab|Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
16394802|NCT04408638|Drug|Glofitamab|Participants will receive IV glofitamab for up to 12 cycles.
16394803|NCT04408638|Drug|Rituxumab|Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
16394804|NCT04408638|Drug|Tocilizumab|Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
16394805|NCT04408638|Drug|Gemcitabine|Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
16394806|NCT04408638|Drug|Oxaliplatin|Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
16394807|NCT04399863|Behavioral|ETOILE therapeutic education|ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.
16394808|NCT04399239|Combination Product|AuriNovo|AuriNovo is a patient-specific, biologically natural, supportive base for surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient's own auricular cartilage cells (chondrocytes). The construct is printed in a size and shape that matches the contralateral ear for implantation into the patient.
16394809|NCT04396574|Drug|Lasmiditan|Administered orally
16394810|NCT04396236|Drug|Lasmiditan|Administered orally
16394811|NCT04396236|Drug|Placebo|Administered orally
16394812|NCT04392167|Device|a/LCI-OCT imaging probe|a/LCI and OCT imaging measurements of several locations in the esophagus
16394813|NCT04392167|Procedure|esophageal biopsy|biopsies of esophageal tissue imaged by a/LCI-OCT probe
16394814|NCT04388826|Drug|Veru-111|Respiratory Distress Syndrome, Adult
16394815|NCT04388501|Drug|Milvexian|Participants will receive milvexian capsules orally qd for 5 days as per the assigned treatment sequence.
16394816|NCT04388501|Drug|Atorvastatin|Participants will receive atorvastatin tablets orally qd for 5 days as per the assigned treatment sequence.
16394817|NCT04387071|Biological|Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949|Given IT
16394818|NCT04387071|Drug|VLP-encapsulated TLR9 Agonist CMP-001|Given SC and IT
16394821|NCT04384952|Other|Parent-administered reading therapy.|Parent-administered reading therapy program: 15min each day, 5 days a week during 6 weeks during the summer break. Repeted reading with feedback from the parent and time control.
16394822|NCT04384952|Other|Dyslexic's Holiday Workbook|Use of a special Dyslexic's holiday book, no parent-guided training.
16394823|NCT04382664|Biological|UV1|UV1 vaccine (300 μg) will be injected intradermally.
16394824|NCT04382664|Biological|Sargramostim|Sargramostim (75 μg) is used as a vaccine adjuvant.
16394825|NCT04382664|Biological|Ipilimumab|Ipilimumab is dosed according to label.
16394826|NCT04382664|Biological|Nivolumab|Nivolumab is dosed according to label.
16394833|NCT04366102|Other|Multisensory stimulation with soft tissue therapy|Multisensory stimulation with soft tissue therapy will be given. Multisensory stimulation consists of Auditory, vestibular, tactile, olfactive, oromotor, Visual, and Kinesthetic stimulation. Soft tissue therapy consists of stroking, effleurage, fingertip kneading, tapping, and skin rolling will be given. Total intervention will be given for 30 min. 5 times per week
16394834|NCT04366102|Other|Routine hospital care|Routine hospital care will be given to the preterm neonates
16394835|NCT04357457|Drug|Almitrine|Intravenous almitrine at a dose of 2 µg.kg-1.min-1 during 5 days
16394837|NCT04356339|Drug|Interferon-beta-1b (BETASERON, BAY 86-5046)|Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician
16394838|NCT04355858|Drug|SHR7390|MEK1/2 inhibitor
16394839|NCT04355858|Drug|Famitinib|Multi-target tyrosine kinase inhibitor
16394840|NCT04355858|Drug|SHR3162|PARP inhibitor
16394841|NCT04355858|Drug|Pyrotinib|HER1 / HER2 receptor tyrosine kinase inhibitor
16394842|NCT04355858|Drug|Capecitabine|In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.
16394843|NCT04355858|Drug|SHR1210|PD-1 antibody
16394844|NCT04355858|Drug|Everolimus|mTOR inhibitor
16394845|NCT04355858|Drug|Nab paclitaxel|Albumin bound paclitaxel
16394846|NCT04355858|Drug|SHR2554|EZH2 inhibitor
16394847|NCT04355858|Drug|SHR3680|AR inhibitor
16394848|NCT04355858|Drug|SHR6390|CDK4/6 inhibitor
16394849|NCT04355858|Drug|SHR1701|anti-PD-L1/TGF-βRII bifunctional fusion protein
16394850|NCT04355858|Drug|SERD|Fulvestrant
16394851|NCT04355858|Drug|AI|aromatase inhibitor
16394852|NCT04355858|Drug|VEGFi|Bevacizumab
16394853|NCT04345991|Drug|Transfusion of COVID-19 convalescent plasma|Two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. In the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient
16394854|NCT04343573|Radiation|Involved-field Photon Radiation Therapy|Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions)
16394855|NCT04343573|Radiation|Proton Craniospinal Irradiation (CSI)|Proton CSI (30Gy [RBE] in 10 fractions)
16394856|NCT04343573|Other|Neurocognitive Assessment|All patients at MSKCC will complete a neurocognitive test battery at study entry (prior to RT), and approximately 3, 6 and 12 months and post -RT. The neurocognitive tests consists of standardized, validated and reliable measures of attention, executive functions, and memory, for which age- and education-matched healthy control published data are available. Patients will also complete self-report mood and fatigue scales at each of the same time points. This testing will only be done at MSKCC. Non-English-speaking patients and pediatric patients are exempt from completing the neurocognitive assessments. Neurocognitive assessments will be performed in person at MSK-Manhattan; an option to perform follow up assessments via telehealth will be available only for patients who are not able to go to Manhattan for these visits.
16394857|NCT04343573|Other|MDASI-BT and MDASI-SP|Using MDASI-BT and MDASI-SP questionnaires before, weekly during, at 3 months (+/- 4 weeks), 6 months (+/- 4 weeks), 9 months (+/- 4 weeks), and 12 months (+/- 4 weeks) after group assignment, and at CNS disease progression. Only one set needs to be completed. Non-English-speaking patients and pediatric patients are exempt from completing the patient-reported outcomes unless translated PRO assessment forms are available. Questionnaires will be completed via mail, in-person, or online (MSK Engage).
16394859|NCT04338321|Drug|Esketamine 28 mg|Esketamine will be self-administered at a dose of 28 mg as nasal spray.
16394860|NCT04338321|Drug|Esketamine 56 mg|Esketamine will be self-administered at a dose of 56 mg as nasal spray.
16394861|NCT04338321|Drug|Esketamine 84 mg|Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.
16394862|NCT04338321|Drug|Quetiapine XR 50 mg|Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
16394863|NCT04338321|Drug|Quetiapine XR 100 mg|Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
16394864|NCT04338321|Drug|Quetiapine XR 150 mg|Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
16394865|NCT04338321|Drug|SSRI/SNRI|Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).
16394866|NCT04338061|Drug|Evobrutinib|Evobrutinib twice daily (BID) in double-blind (DB) treatment period.
16394867|NCT04338061|Drug|Placebo (match to Teriflunomide)|Placebo match to Teriflunomide once daily in double-blind treatment period.
16394868|NCT04338061|Drug|Teriflunomide|Teriflunomide once daily in double-blind treatment period.
16394869|NCT04338061|Drug|Placebo (match to Evobrutinib)|Placebo match to Evobrutinib BID in double-blind treatment period.
16394870|NCT04338061|Drug|Evobrutinib|Evobrutinib BID in Open-Label Extension Period.
16394871|NCT04338022|Drug|Evobrutinib|Evobrutinib twice daily (BID) in double-blind (DB) treatment period.
16394872|NCT04338022|Drug|Placebo (match to Teriflunomide)|Placebo match to Teriflunomide once daily in double-blind treatment period.
16394873|NCT04338022|Drug|Teriflunomide|Teriflunomide once daily in double-blind treatment period.
16394874|NCT04338022|Drug|Placebo (match to Evobrutinib)|Placebo match to Evobrutinib BID in double-blind treatment period.
16394875|NCT04338022|Drug|Evobrutinib|Evobrutinib BID in Open-Label Extension Period.
16394877|NCT04320407|Device|Osia 2 System|"The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.
~Reference device for Cohort 1 Osia: Baha 5 Power sound processor on the Baha Sound Arc."
16394881|NCT04315701|Biological|Cemiplimab|Given IV
16394882|NCT04315701|Procedure|Resection|Undergo surgical resection
16394883|NCT04314414|Other|PRC brief motivational interview intervention|The intervention will involve the following elements: establishing rapport, asking permission to discuss drugs, discussing the pros and cons associated with drug use, uncovering the gaps between current and desired quality of life and determining readiness to change. The intervention will last approximately 20 minutes and take place at the time of the clinical visit while participants are waiting to be seen by a clinician or are awaiting laboratory testing.
16394884|NCT04314414|Other|Phone contact|The PRC will remain in at least weekly contact by phone with each participant.
16394885|NCT04313361|Other|No intervention|No drug will be administered as part of this study.
16394886|NCT04312672|Biological|AAV-RPGR|Genetic
16394887|NCT04307849|Behavioral|Adolescent Health Club|Sexual health/HIV-related evidence-based interventions
16394888|NCT04307849|Other|Wait-list Control|The wait-listed group will begin the intervention after the intervention group
16394889|NCT04305431|Behavioral|Cooking Intervention|90-minute culinary education sessions.
16394890|NCT04302025|Drug|Alectinib|Participants will receive oral alectinib twice per day (BID)
16394891|NCT04302025|Drug|Entrectinib|Participants will receive oral entrectinib daily
16394892|NCT04302025|Drug|Vemurafenib|Participants will receive oral vemurafenib BID
16394893|NCT04302025|Drug|Cobimetinib|Participants will receive oral cobimetinib daily
16394894|NCT04302025|Procedure|Resection|Participants will receive surgical resection of the primary tumor along with selected lymph nodes
16394895|NCT04302025|Drug|Chemotherapy|Participants will receive standard of care (SOC) chemotherapy as determined by the treating physician
16394896|NCT04302025|Drug|Pralsetinib|Participants will receive oral pralsetinib daily
16394897|NCT04288778|Drug|Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)|Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.
16394898|NCT04280640|Other|Blood Draw|A blood sample will be collected once, prior to treatment.
16394899|NCT04276441|Device|Heart healthy Engagement Program with the Apple Watch Series 4 or later|No drug will be given as part of this study. Participants without a diagnosis of AF will be enrolled and a heart healthy Engagement Program delivered via the Heartline app on the iPhone with the Apple Watch Series 5 or later.
16394900|NCT04276441|Device|Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later|No drug will be given as part of this study. Participants with a diagnosis of AF (taking a DOAC for at least 30 days) will be enrolled and an Anti Coagulation Adherence Module delivered via the Heartline app on the iPhone with an Apple Watch Series 5 or later.
16394901|NCT04273724|Other|Targeted Interventions for Impairments Identified During Geriatric Assessment|Participants will be referred for specific evidence-based interventions based on impairments identified during a baseline comprehensive geriatric assessment.
16394902|NCT04267393|Drug|BMS-986263|Specified dose on specified days
16394903|NCT04267393|Other|Placebo|Specified dose on specified days
16394904|NCT04266249|Drug|Docetaxel|Given IV
16394905|NCT04266249|Procedure|Lumpectomy|Undergo lumpectomy
16394906|NCT04266249|Procedure|Mastectomy|Undergo mastectomy
16394907|NCT04266249|Drug|Nab-paclitaxel|Given IV
16394908|NCT04266249|Drug|Paclitaxel|Given IV
16394909|NCT04266249|Biological|Pertuzumab|Given IV
16394910|NCT04266249|Radiation|Radiation Therapy|Undergo radiation therapy
16394911|NCT04266249|Biological|Trastuzumab|Given IV
16394912|NCT04266249|Biological|Trastuzumab Emtansine|Given IV
16394913|NCT04259281|Drug|GTX-102|antisense oligonucleotide
16394916|NCT04258449|Device|DOvEEgene Fleur Sampling|Patients will undergo uterine sampling with DOvEEgene Fleur endometrial sampling device prior to surgical intervention, in addition to standard of care treatment.
16394917|NCT04257201|Other|Yellow Oyster -- 84 g|Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
16394918|NCT04257201|Other|Yellow Oyster -- 168 g|Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
16394919|NCT04257201|Other|White button -- 84 g|Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
16394920|NCT04257201|Other|White button -- 168 g|Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served
16394921|NCT04257201|Other|Control|Participants will consume the standardized test day salad only
16394928|NCT04252287|Drug|Canagliflozin 100 mg|Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
16394929|NCT04252287|Drug|Placebo|Participants will receive matching placebo capsules orally once daily.
16394930|NCT04251546|Diagnostic Test|p2PSA|p2PSA test(for calculation of PHI)
16394931|NCT04251546|Diagnostic Test|Ultrasonic parameters|Ultrasonic parameters(TPV)
16394932|NCT04251546|Diagnostic Test|Transperineal prostate biopsy|Transperineal prostate biopsy for confirmation of prostate cancer or benign disease
16394933|NCT04249076|Drug|Clobetasol Propionate|Clobetasol propionate ophthalmic nanoemulsion 0.05% is an oil-in-water (o/w), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w)
16394934|NCT04249076|Drug|Vehicle|Vehicle is identical in appearance and composition to clobetasol propionate ophthalmic nanoemulsion 0.05% but, without the active substance
16394935|NCT04246801|Drug|Clobetasol propionate|Clobetasol propionate ophthalmic nanoemulsion 0.05%, is an oil-in-water (o/w), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w)
16394936|NCT04246801|Drug|Vehicle|Vehicle is identical in appearance and composition to clobetasol propionate ophthalmic nanoemulsion 0.05% but, without the active substance
16394937|NCT04243005|Procedure|Supramarginal resection|Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe
16394938|NCT04243005|Procedure|Conventional surgery|Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.
16394939|NCT04241224|Device|Atherectomy|Endovascular treatment of peripheral arterial disease
16394940|NCT04221815|Device|Eagle Eye Platinum digital IVUS catheter with optional SyncVision|IVUS catheter
16394941|NCT04221815|Device|Resolute Onyx Drug Eluting Stent|Stent
16394942|NCT04221451|Drug|venglustat GZ402671|"Pharmaceutical form: tablet
~Route of administration: oral"
16394943|NCT04221451|Drug|placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
16394944|NCT04216342|Biological|Fx-5A peptide complex|subject will receive a slow I.V. infusion of the Fx-5A peptide complex as described in Table 1. Five to 10 mL of blood will be collected at 30min (+/- 5min*), 1h (+/- 10min*), 2h (+/- 10min*), 4h (+/- 15min*), 8h (+/- 30min*), 12h (+/- 30min*), and 24h (+/- 30min*) for laboratory tests and to be stored for research tests. The patient will be dismissed, as inpatient, 24-36 hours after the beginning of the treatment.
16394945|NCT04209114|Biological|Nivolumab|Specified dose on specified days
16394946|NCT04209114|Biological|Bempeg|Specified dose on specified days
16394947|NCT04209114|Procedure|Radical cystectomy (RC)|Surgical removal of the bladder
16394948|NCT04206332|Drug|VRC-MALMAB0100-00-AB|VRC-MALMAB0100-00-AB is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum circumsporozoite protein. The monoclonal antibody was adapted resulting in an LS mutation found to increase product half-life in plasma.
16394949|NCT04206332|Other|CHMI|Negative control designed to test the infection ability of the CHMI.
16394950|NCT04201418|Drug|Patisiran|Patisiran-lipid complex injection, for intravenous use
16394951|NCT04200755|Drug|Dupilumab 300Mg Solution for Injection|First dose: 600 mg (2 syringes); subsequent doses: 300 mg (1 syringe)
16394952|NCT04200755|Other|Placebo|First dose: 2 syringes, no active substance; subsequent doses: 1 syringe, no active substance
16394953|NCT04188548|Drug|LY3484356|Administered orally
16394954|NCT04188548|Drug|Abemaciclib|Administered orally
16394955|NCT04188548|Drug|Everolimus|Administered orally
16394956|NCT04188548|Drug|Alpelisib|Administered orally
16394957|NCT04188548|Drug|Trastuzumab|Administered intravenously
16394958|NCT04188548|Drug|Aromatase Inhibitor (AI)|Anastrozole or Exemestane or Letrozole administered orally (physician choice)
16394959|NCT04173533|Drug|Oral azacitidine|Oral azacitidine (CC-486) 200 mg tablet
16394960|NCT04173533|Drug|Matched placebo|Oral azacitidine (CC-486) matched placebo tablet
16394961|NCT04171115|Drug|G03-52-01|G03-52-01 administered intramuscularly
16394962|NCT04171115|Drug|Placebo|Placebo administered intramuscularly
16394963|NCT04170478|Device|Echolaser X4 system|Transperineal laser ablation
16394964|NCT04167033|Drug|Hormone replacement therapy:effect on ventricular repolarization|Hormone replacement therapy and QTc measurement
16394965|NCT04167033|Diagnostic Test|ECG|QTc measurement
16394966|NCT04165239|Drug|KH176|Oral administration of 50 mg KH176 twice daily
16394967|NCT04165239|Drug|KH176|Oral administration of 100 mg KH176 twice daily
16394968|NCT04165239|Drug|Placebo|Oral administration of matching placebo twice daily
16394969|NCT04164732|Drug|LCZ696|LCZ696 at doses of 50mg, 100mg and 200mg b.i.d oral
16394970|NCT04164732|Drug|Placebo|placebo
16394971|NCT04153149|Drug|Vutrisiran|Vutrisiran 25 mg will be administered by SC injection q3M.
16394972|NCT04153149|Drug|Sterile Normal Saline (0.9% NaCl)|Sterile normal saline (0.9% NaCl) will be administered by SC injection q3M.
16394973|NCT04152200|Drug|Lumasiran|Lumasiran will be administered by subcutaneous (SC) injection.
16394974|NCT04150380|Biological|Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766)|See arm descriptions
16394975|NCT04150380|Other|Placebo|See arm descriptions
16394976|NCT04145700|Drug|Ramucirumab|Ramucirumab given IV
16394977|NCT04145700|Drug|Gemcitabine|Gemcitabine given IV
16394978|NCT04145700|Drug|Docetaxel|Docetaxel given IV
16394979|NCT04145531|Drug|IM JZP-458|IM JZP-458 will be administered in Part A, Cohorts 1 & 2
16394980|NCT04145531|Drug|IV JZP-458|IV JZP-458 will be administered in Part B
16394981|NCT04145349|Drug|Ramucirumab|Administered IV
16394982|NCT04145349|Drug|Cyclophosphamide|Administered orally
16394983|NCT04145349|Drug|Vinorelbine|Administered IV
16394984|NCT04140773|Dietary Supplement|D-serine|Capsule D-serine
16394985|NCT04140773|Other|Placebo|Capsule D-serine
16394986|NCT04140500|Drug|RO7247669|Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
16395367|NCT03155347|Drug|Placebo Matched to MTX|Placebo matched to MTX.
16394991|NCT04133688|Device|ASC|mobile app
16394994|NCT04125472|Drug|Lumasiran|Lumasiran administered as a subcutaneous (SC) injection
16394998|NCT04109066|Biological|nivolumab|Specified Dose on Specified days
16394999|NCT04109066|Drug|paclitaxel (PTX)|Specified dose on Specified days
16395000|NCT04109066|Other|nivolumab placebo|Specified dose on Specified days
16395001|NCT04109066|Drug|anthracycline|Specified dose on Specified days
16395002|NCT04109066|Drug|cyclophosphamide|Specified dose on Specified days
16395003|NCT04109066|Drug|Endocrine Therapy|Variable endocrine therapy of investigators choice
16395004|NCT04109066|Procedure|Surgery|Surgery for breast cancer
16395005|NCT04106544|Procedure|Investigational Procedures|The investigational assessments will be performed
16395006|NCT04100018|Biological|Nivolumab|Specified dose on specified days
16395007|NCT04100018|Drug|Prednisone|Specified dose on specified days
16395008|NCT04100018|Drug|Docetaxel|Specified dose on specified days
16395009|NCT04100018|Other|Placebo|Specified dose on specified days
16395010|NCT04099290|Other|Blood and tumor samples|Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.
16395011|NCT04094441|Other|chest physiotherapy|chest physiotherapy
16395012|NCT04093492|Other|Preemie Prep for Parents (P3) Outpatient Mobile Intervention|The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.
16395013|NCT04093492|Other|ACOG links|Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.
16395014|NCT04088396|Drug|Baricitinib|Administered orally
16395015|NCT04088396|Drug|Placebo|Administered orally
16395016|NCT04086745|Drug|Baricitinib|Administered orally.
16395017|NCT04086745|Drug|TNF Inhibitor|Administered SC
16395022|NCT04085705|Diagnostic Test|PATCH test|The PATCH test is a method used to determine whether a specific substance causes allergic inflammation of a patient's skin, in this case contact allergy for wound dressings. Two days after PATCH test is applied, the patches are removed. The next day, the presence of a contact allergy is determined.
16395023|NCT04077723|Drug|RO7227166|RO7227166 will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
16395024|NCT04077723|Drug|Obinutuzumab|A fixed dose of obinutuzumab will be administered seven days prior to first does of RO7227166 and glofitamab and then Q3W in combination with RO7227166 in Part I
16395025|NCT04077723|Drug|Glofitamab|A fixed dose of glofitamab will be administered Q3W in combination with RO7227166 in Part II and Part III
16395026|NCT04077723|Drug|Tocilizumab|Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
16395027|NCT04075110|Drug|Montelukast 10mg|Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.
16395028|NCT04074590|Drug|LYS006|capsule for oral use
16395029|NCT04074590|Drug|Placebo|capsule for oral use
16395030|NCT04072575|Drug|PP6M injection Dose 1|Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.
16395031|NCT04072575|Drug|PP6M injection Dose 2|Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.
16395032|NCT04066049|Behavioral|EMT en Español|EMT en Español utilizes intervention strategies adapted from Enhanced Milieu Teaching (Kaiser & Hampton, 2016), an evidence-based naturalistic communication intervention, to promote home language and improve children's language use across the day in home routines, play, and book sharing in individual sessions with a therapist and in caregiver training sessions.
16395033|NCT04060355|Behavioral|Savvy program|Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
16395068|NCT03985839|Device|MICRORAPTOR™ REGENESORB™ Suture Anchor|Smith & Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.
16395540|NCT02304757|Drug|Fosamax|H20080172
16395034|NCT04060355|Behavioral|Semi-structured video interviews|Semi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials
16395035|NCT04055636|Diagnostic Test|Echocardiography with speckle tracking analysis.|Transthoracic echocardiography with speckle tracking analysis.
16395036|NCT04055636|Diagnostic Test|48-hour ECG monitoring.|Ambulatory 48-hour electrocardiography monitoring.
16395037|NCT04055636|Diagnostic Test|Blood samples analysis.|Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
16395041|NCT04048538|Other|Precare|an innovative patient education platform using animated videos created by using up-to-date evidence-based informaiton
16395042|NCT04048538|Other|usual standard of care|individuals will receive treatment as per the usual standard of care
16395043|NCT04048252|Other|Focus group creation|Patients will join with researchers for a 2 hour recorded group discussion to highlight themes identified to require educational intervention
16395044|NCT04048252|Other|Workshop|Patients will attend 3-4 workshops on eg disease knowledge, medication management and side effects, adapted physical activity and nutrition
16395045|NCT04047628|Procedure|Autologous Hematopoietic Stem Cell Transplantation|"PBSC mobilization & collection regimen per protocol/ institutional standards includes: intravenous cyclophosphamide (Cytoxan®), 4 grams/m^2); intravenous mesna (Mesnex®),a total delivery of 4 grams/m^2); oral dexamethasone, 10 mg dose, four times daily); subcutaneous filgrastim,10 mcg/kg/day until leukapheresis goal is completed; and CD34+ peripheral blood stem cells collection by leukapheresis.
~Conditioning per protocol& institutional standards:
~6-day BEAM (e.g. Carmustine (BCNU), Etoposide (VP-16), Cytarbine (Ara-C), and Melphalan) chemotherapy protocol and,
~rabbit anti-thymocyte globulin (rATG) 2.5 mg/kg/day x2
~Autologous cryopreserved graft infusion: The target Cluster of Differentiation (CD)34+ cell dose for infusion is 5 x 10^6 CD34+ cells/kg (minimum 4 x 10^6 CD34+ cells/kg; maximum 7.5 x 10^6 CD34+ cells/kg).
~For 1&2 above: Ideal body weight (IBW) versus Actual Body Weight (ABW) are applicable."
16395046|NCT04047628|Biological|Best Available Therapy (BAT)|"Disease-modifying therapy (DMT) selected by the Site Investigator from the below:
~cladribine
~natalizumab
~alemtuzumab
~ocrelizumab,
~rituximab, or
~ofatumumab"
16395047|NCT04039607|Drug|Nivolumab|Participants will receive nivolumab as intravenous (IV) infusion.
16395048|NCT04039607|Drug|Ipilimumab|Participants will receive ipilimumab as IV infusion.
16395049|NCT04039607|Drug|Sorafenib|Participants will receive sorafenib as oral tablets.
16395050|NCT04039607|Drug|lenvatinib|Participants will receive lenvatinib as oral capsules.
16395051|NCT04037215|Other|STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE|"Describe the cognitive treatment of patients with early onset anorexia nervosa in response to specific stimuli of the disorder (eating and body images), compared to age- and sex-matched control subjects:
~children controls not achieved with normal BMI;
~children with unbalanced insulin-dependent type 1 diabetes, therefore subject to a strict diet that requires good nutritional knowledge and no weight judgment disorders."
16395052|NCT04028401|Drug|5% benzoyl peroxide|Application of 5% benzoyl peroxide during 5 days before the procedure
16395053|NCT04024943|Device|Quadripolar LV Lead|The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location.
16395054|NCT04023604|Other|Controlled diet with beef raised without antibiotics|The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised without antibiotics.
16395055|NCT04023604|Other|Controlled diet with beef produced in conventional systems|The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised with antibiotics.
16395056|NCT04017910|Device|EchoMark/EchoSure|Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.
16395057|NCT04016636|Other|Standard of Care|Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 12 months.
16395058|NCT04010539|Drug|Gepotidacin|Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.
16395059|NCT04010539|Drug|Ceftriaxone|Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.
16395060|NCT04010539|Drug|Azithromycin|Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water.
16395061|NCT04001829|Drug|Docetaxel|Given IV
16395062|NCT04001829|Drug|Paclitaxel|Given IV
16395063|NCT04001829|Other|Quality-of-Life Assessment|Ancillary studies
16395064|NCT04001829|Other|Questionnaire Administration|Ancillary studies
16395065|NCT03997383|Drug|Placebo|Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.
16395066|NCT03997383|Drug|Patisiran|Patisiran will be administered by intravenous (IV) infusion.
16395067|NCT03994627|Drug|Olaratumab|Administered intravenously (IV)
16395069|NCT03985839|Device|MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor|MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.
16395070|NCT03985839|Device|MICRORAPTOR™ Knotless PEEK Suture Anchor|The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.
16395071|NCT03971929|Drug|SHR0532|once daily(QD) for 4weeks
16395072|NCT03971929|Drug|SHR placebo|once daily(QD) for 4weeks
16395073|NCT03971929|Drug|Hydrochlorothiazide 25 mg|once daily(QD) for 4weeks
16395074|NCT03971084|Other|Sugar free gum without CPP-ACP|Sugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
16395075|NCT03971084|Other|Sugar free gum with CPP-ACP|Sugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
16395076|NCT03958630|Drug|11C-ER176|PET biomarker for inflammation
16395077|NCT03958630|Drug|11C-PIB|PET biomarker for amyloid
16395078|NCT03954574|Diagnostic Test|assessment of pulmonary hemodynamics during exercise by right heart catheterization|all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
16395079|NCT03947619|Device|Impella CP® placement prior to reperfusion with Primary PCI|Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
16395080|NCT03943498|Drug|Fingolimod|Given PO daily for 4 weeks
16395081|NCT03943498|Drug|Fingolimod Hydrochloride|Given PO
16395082|NCT03943498|Other|Questionnaire Administration|Ancillary studies
16395083|NCT03941743|Drug|Fingolimod|Given PO
16395084|NCT03941743|Drug|Fingolimod Hydrochloride|Given PO
16395085|NCT03941743|Other|Questionnaire Administration|Ancillary studies
16395086|NCT03930732|Drug|Dupilumab SAR231893|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16395087|NCT03930732|Drug|Inhaled Corticosteroid|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16395088|NCT03930732|Drug|Inhaled Long-Acting Beta Agonist|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16395089|NCT03930732|Drug|Inhaled Long-Acting Muscarinic Antagonist|"Pharmaceutical form: Inhaled Powder
~Route of administration: Oral inhalation"
16395090|NCT03930732|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
16395091|NCT03926130|Drug|Mirikizumab|Administered IV
16395092|NCT03926130|Drug|Mirikizumab|Administered SC
16395093|NCT03926130|Drug|Ustekinumab|Administered IV
16395094|NCT03926130|Drug|Ustekinumab|Administered SC
16395095|NCT03926130|Drug|Placebo|Administered IV
16395096|NCT03926130|Drug|Placebo|Administered SC
16395097|NCT03925389|Procedure|External septorhinoplasty|A surgical procedure to repair defects or deformities of both the nasal septum and the external nasal pyramid through an external incision at the columella.
16395098|NCT03925142|Other|Controlled healthy vegetarian diet|The controlled healthy vegetarian diet will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern.
16395099|NCT03925142|Other|Controlled beef diet|The controlled beef diet will incorporate various cuts of lean unprocessed red meat into the healthy vegetarian eating pattern, as approved by the American Heart Association's Food Certification Program. The beef diet will isocalorically replace starchy vegetables and/or refined grains with 6 oz. of beef/day for five weeks.
16395102|NCT03916263|Drug|Metformin|Traditional care including diet, exercise and metformin
16395103|NCT03916263|Other|One-On-One Dietary Instruction|Participant receives one-on-one dietary counseling from study personnel
16395104|NCT03916263|Other|Video Dietary Instruction|Participant receives video dietary instruction
16395105|NCT03909178|Procedure|Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)|Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement, puncture capsulotomy, autograft capsular augmentation if insufficient or degenerative labral tissue is encountered, intermittent traction, sparing use of electrocautery, and preservation of the chrondrolabral junction. All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months.
16395106|NCT03909178|Procedure|Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)|PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks 1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week).
16395107|NCT03906331|Drug|Selpercatinib|Open-label expanded access
16395108|NCT03905694|Drug|Lumasiran|Lumasiran will be administered by subcutaneous (SC) injection.
16395109|NCT03903094|Other|Non-Interventional|Overview of anticholinergic burden, rather than to evaluate specific drugs
16395110|NCT03896620|Device|Preoperative RT|Radiation delivered before surgery.
16395111|NCT03896620|Device|Postoperative RT|Radiation delivered after surgery.
16395112|NCT03896620|Drug|Chemotherapy|Physician's choice of chemotherapy.
16395113|NCT03896620|Other|Surgery|Surgical excision of tumor.
16395116|NCT03895684|Drug|SP-2577 Seclidemstat|Dose escalation and dose expansion of SP-2577.
16395120|NCT03893370|Device|RejuvenAir System|RejuvenAir Metered CryoSpray
16395121|NCT03893370|Device|Sham Control Procedure|Sham Control Procedure
16395122|NCT03891368|Other|Virtual Learning Collaborative|InSHAPE teams consisting of health mentors, supervisors, and senior leaders from each mental health agency randomized to the VLC will be invited to attend an in-person initial kick-off meeting followed by once per month 90-minute VLC sessions. The VLC is organized into three stages: Prework, Action, and Continuous Improvement. VLC faculty, including interventionists with expertise in implementation science, quality improvement, and subject matter (i.e., InSHAPE) experts, will facilitate VLC sessions following a structured protocol to standardize the planning and execution of the VLC across three cohorts enrolled in the study.
16395123|NCT03891368|Other|Technical Assistance|Scheduled calls will occur at 1 month, 2 months, 8 months, and 14 months following their participation in initial InSHAPE training following randomization and follow a structured protocol. At the end of each scheduled conference call, the coach will schedule the next call with the site.
16395125|NCT03873402|Biological|Nivolumab|Specified dose on specified days
16395126|NCT03873402|Biological|Ipilimumab|Specified dose on specified days
16395127|NCT03873402|Other|Ipilimumab placebo|Specified dose on specified days
16395128|NCT03872479|Drug|EDIT-101|Participants will receive a single dose of EDIT-101 administered via subretinal injection in the study eye. Up to 5 cohorts across 3 doses will be enrolled in this study.
16395129|NCT03866239|Drug|Obinutuzumab|Obinutuzumab will be administered by intravenous (IV) infusion as either a split or single dose approximately 2 weeks before Cycle 1, Day 1 (cycle = 21 days).
16395130|NCT03866239|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle until radiographic progression, unacceptable toxicity, or loss of clinical benefit.
16395131|NCT03866239|Drug|Cibisatamab|Cibisatamab will be administered at a fixed dose of 100 mg by IV infusion on Day 1 of each 21-day cycle until radiographic progression, unacceptable toxicity, or loss of clinical benefit.
16395132|NCT03866239|Drug|Tocilizumab|Tocilizumab will be administered by IV infusion as necessary to manage adverse events (AEs)
16395133|NCT03864406|Drug|Tybost (Cobicistat)|Each tablet of Tybost contains 150 mg of cobicistat.
16395134|NCT03864406|Drug|Prezcobix (Darunavir/Cobicistat)|Each tablet of Prezcobix contains 800 mg of darunavir and 150 mg of cobicistat.
16395135|NCT03864406|Drug|Xarelto (Rivaroxaban)|Each tablet of Xarelto contains 10 mg of rivaroxaban.
16395136|NCT03864406|Drug|Eliquis (Apixaban)|Each tablet of Eliquis contains 5 mg of apixaban.
16395137|NCT03859258|Device|Transvaginal sonography|Niche is assessed using TVS, SIS (cases only) and office hysteroscopy
16395138|NCT03858205|Other|Quality-of-Life Assessment|Ancillary studies
16395139|NCT03858205|Other|Questionnaire Administration|Ancillary studies
16395140|NCT03858205|Radiation|Radiation Therapy|Receive low-dose radiation therapy
16395141|NCT03848754|Drug|Gemtuzumab Ozogamicin 3 mg/m^2|"GO 3 mg/m^2 on Day 1, 4, and 7
~Maintenance: 2mg/m2 intravenous administration on day 1, in a 28-day cycle."
16395142|NCT03848754|Drug|Gemtuzumab Ozogamicin 2 mg/m^2|GO 2 mg/m^2 on Day 1 of a 28-day cycle.
16395143|NCT03848754|Drug|Pracinostat - 45 mg|Induction: 45mg administered orally 3 days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by 1 week of rest, in 28-day cycles.
16395144|NCT03848754|Drug|Pracinostat - 60 mg|Escalation: 60 mg administered orally three days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by one week of rest, in 28-day cycles.
16395145|NCT03847701|Other|Balanced diet high in Slowly Digestible Starch|The carbohydrates present in high Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.
16395146|NCT03847701|Other|Balanced diet low in Slowly Digestible Starch|The carbohydrates present in low-Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.
16395147|NCT03843125|Drug|Baricitinib|Administered orally.
16395148|NCT03842865|Biological|Vigil|Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).
16395149|NCT03832647|Combination Product|Epiduo|100 per arm Adapalene/ Benzoyl Peroxide
16395150|NCT03832647|Drug|Salicylic Acid|Salicylic Acid
16395151|NCT03832647|Other|Hydréane légère|moisturizer
16395152|NCT03816319|Drug|UAE Inhibitor TAK-243|Given IV
16395153|NCT03815825|Drug|IONIS-FB-LRx|IONIS-FB-LRx at multiple ascending doses, administered subcutaneously every 4 weeks
16395154|NCT03815825|Drug|Placebo|Placebo matching solution, administered subcutaneously every 4 weeks
16395155|NCT03808727|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.
16395156|NCT03806361|Procedure|Fat grafts supplemented with ADRC|Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.
16395157|NCT03806361|Procedure|Structural fat grafting|Fat grafts without supplementation of ADRC
16395158|NCT03789773|Device|Millimeter-Wave Holographic Imaging|Undergo mm-wave holographic imaging
16395163|NCT03784235|Other|18F NaF-PET/CT and cone beam CT scans|Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans
16395164|NCT03778671|Drug|Levobupivacaine|Patients will receive Levobupivacaine 5%
16395165|NCT03778671|Drug|Dexmedetomidine Injection [Precedex]|Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine
16395166|NCT03778671|Drug|fentanyl|Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl
16395167|NCT03775213|Behavioral|Decision Support Tool with Active Monitoring|The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
16395168|NCT03775213|Behavioral|Decision Support Tool without Active Monitoring|The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
16395169|NCT03773965|Drug|Baricitinib|Administered orally.
16395170|NCT03763604|Drug|Abemaciclib|Administered orally.
16395171|NCT03759379|Drug|Patisiran|Patisiran will be administered by intravenous (IV) infusion.
16395172|NCT03759379|Drug|Vutrisiran (ALN-TTRSC02)|Vutrisiran will be administered by subcutaneous (SC) injection.
16395173|NCT03737643|Drug|Bevacizumab|Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
16395174|NCT03737643|Drug|Durvalumab|Durvalumab by intravenous infusion
16395175|NCT03737643|Drug|Olaparib|Olaparib tablets
16395176|NCT03737643|Drug|Placebo olaparib|Placebo tablets to match olaparib
16395177|NCT03737643|Drug|Durvalumab placebo|Matching placebo for intravenous infusion
16395178|NCT03737643|Drug|Carboplatin+Paclitaxel|Standard of care chemotherapy
16395179|NCT03735680|Drug|ONM-100|A polymer micelle covalently conjugated to indocyanine green, an FDA-approved fluorophore
16395182|NCT03723915|Biological|Pembrolizumab|Given IV
16395183|NCT03723915|Biological|Wild-type Reovirus|Given pelareorep IV
16395184|NCT03718325|Device|Burst-SCS|The treatment arm used in the study is clinically-effective burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
16395185|NCT03718325|Device|Sham SCS|The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
16395186|NCT03706365|Drug|Abemaciclib|Administered orally.
16395187|NCT03706365|Drug|Abiraterone Acetate|Administered orally.
16395188|NCT03706365|Drug|Prednisone|Administered orally.
16395189|NCT03706365|Drug|Placebo|Administered orally.
16395190|NCT03698162|Device|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo STAR DCE-MRI
16395191|NCT03698162|Drug|Bevacizumab Injection|Bevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care.
16395192|NCT03695380|Drug|Cobimetinib|Cobimetinib will be administered at a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle (Stage 1) and PO QD on Days 1-21 (21/7 schedule) at the established dose for the doublet regimen in Stage 1 (Stage 2).
16395193|NCT03695380|Drug|Niraparib|Niraparib will be administered at a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle (Stage 1) and PO QD on Days 1-28 of each 28-day cycle at the established dose for the doublet regimen in Stage 1 (Stage 2).
16395194|NCT03695380|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at the fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle (Stages 1 and 2).
16395195|NCT03692715|Drug|Ciprofloxacin|Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.
16395196|NCT03692715|Drug|Placebo|identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.
16395197|NCT03684785|Drug|Cavrotolimod|Intratumorally dosed cavrotolimod.
16395198|NCT03684785|Biological|Pembrolizumab|Pembrolizumab dosing as per the US prescribing information.
16395199|NCT03684785|Biological|Cemiplimab|Cemiplimab dosing as per the US prescribing information.
16395200|NCT03684785|Drug|Cavrotolimod|Subcutaneously dosed cavrotolimod
16395201|NCT03681184|Drug|Placebo|Placebo by SC injection
16395202|NCT03681184|Drug|Lumasiran|Lumasiran by SC injection
16395206|NCT03669640|Drug|RO6889450|Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.
16395207|NCT03669640|Drug|Placebo|Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
16395208|NCT03664232|Drug|JNJ-42165279|Participants will receive 25 mg JNJ-42165279 orally twice daily for 12 weeks.
16395209|NCT03664232|Drug|Placebo|Participants will receive a matching placebo orally twice daily for 12 weeks.
16395210|NCT03655080|Radiation|Radiation therapy|Using the View Ray System
16395211|NCT03655080|Drug|nab-Paclitaxel|"Dose 15 mg/m^2
~Should be administered by IV over 30 minutes"
16395212|NCT03646448|Behavioral|Motivational Interviewing|Up to three counseling sessions on telephone based on Motivational Interviewing and elements of Cognitive Behavioral Therapy. Counselings are within 12 weeks after the baseline diagnostic interview and follow the stepped care approach.
16395213|NCT03645928|Biological|Lifileucel|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with Lifileucel followed by IL-2 administration. Lifileucel will be administered to patients once (on Day 0) during the study.
16395214|NCT03645928|Biological|LN-145|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.
16395215|NCT03645928|Drug|Pembrolizumab|"Humanized antibody.
~Pembrolizumab will be administered following tumor resection and will continue every 3 weeks or every 6 weeks thereafter for up to 2 years."
16395216|NCT03645928|Biological|LN-145-S1|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145-S1) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.
16395217|NCT03645928|Drug|Ipilimumab|"Monoclonal antibody
~Ipilimumab will be administered as a single dose prior to tumor resection."
16395218|NCT03645928|Drug|Nivolumab|"Monoclonal antibody
~Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks for up to 2 years."
16395219|NCT03644186|Drug|Paclitaxel|Chemotherapy plus HER2 Blockade
16395220|NCT03644186|Drug|Trastuzumab|Chemotherapy plus HER2 Blockade
16395221|NCT03644186|Drug|Pertuzumab|Chemotherapy plus HER2 Blockade
16395222|NCT03644186|Drug|Palbociclib|CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
16395223|NCT03644186|Drug|Letrozole|CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
16395224|NCT03644186|Drug|Trastuzumab|CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
16395225|NCT03644186|Drug|Pertuzumab|CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
16395226|NCT03635788|Drug|Standard of Care (SOC) Oral ART|SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)
16395227|NCT03635788|Drug|Oral RPV|RPV 25 mg tablets
16395228|NCT03635788|Drug|Oral CAB|CAB 30 mg tablets
16395229|NCT03635788|Drug|RPV-LA Loading Dose|900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
16395230|NCT03635788|Drug|CAB-LA Loading Dose|600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
16395231|NCT03635788|Drug|RPV-LA Maintenance Dose|600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
16395232|NCT03635788|Drug|CAB-LA Maintenance Dose|400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle
16395233|NCT03632941|Biological|VRP-HER2|VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
16395234|NCT03632941|Biological|Pembrolizumab|A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
16395235|NCT03629951|Drug|Oral Antipsychotics (OAP)|This is an observational study. Participants enrolled in this study will continue to receive routine treatment of OAPs for example, risperidone (1 to 6 mg OD to BID), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to TID) etc, as directed by their treating physician.
16395236|NCT03626857|Device|Neuromuscular Electrical Stimulation (NMES)|The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of at least 40& of the contralateral MVIC.
16395237|NCT03626857|Other|Eccentric Exercise (ECC)|4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum
16395238|NCT03626857|Device|Neuromuscular Electrical Stimulation (NMES) placebo|The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of 10-20% of the contralateral MVIC.
16395239|NCT03626857|Other|Eccentric Exercise (ECC) placebo|4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum
16395240|NCT03626389|Other|Physiotherapy|
16395243|NCT03616964|Drug|Baricitinib|Administered orally.
16395244|NCT03616964|Drug|Placebo|Administered orally
16395245|NCT03616912|Drug|Baricitinib|Administered orally.
16395246|NCT03616912|Drug|Placebo|Administered orally.
16395247|NCT03605836|Drug|Centanafadine SR|100 mg, BID, oral tablets
16395248|NCT03605836|Other|Placebo|BID, oral tablet
16395249|NCT03605836|Drug|Centanafadine SR|200 mg, BID, oral tablets
16395252|NCT03587805|Drug|Tralokinumab|Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
16395253|NCT03574753|Drug|ABBV-399|ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
16395254|NCT03568292|Other|Best Practice|Receive standard of care
16395255|NCT03568292|Other|Laboratory Biomarker Analysis|Correlative studies
16395256|NCT03568292|Device|Oculus Rift Headset|Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure
16395257|NCT03568292|Other|Questionnaire Administration|Ancillary studies
16395258|NCT03567213|Device|Surgical implantation of CortiCom system|Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.
16395259|NCT03563066|Drug|Benralizumab|Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 & 56.
16395260|NCT03563066|Drug|Placebo Control|Subcutaneous placebo injections once per month for 3 months on Days 0, 28 & 56.
16395261|NCT03558789|Biological|bovine lactoferrin|mouthwash
16395262|NCT03556332|Drug|Carfilzomib|Dara-CRd Induction Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 27 mg/m2 per dose, days 8, 9, 15, and 16 Cycles 2-4: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
16395263|NCT03556332|Drug|Lenalidomide|Dara-CRd Induction Cycles 1-4: Lenalidomide 25 mg/day, days 1-21 every 28 days Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
16395264|NCT03556332|Drug|Dexamethasone|Dara-CRd Induction Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23
16395265|NCT03556332|Drug|Daratumumab|"Dara-CRd Induction Cycles 1 and 2: Daratumumab 16 mg/kg weekly (days 1,8, 15, 22) Dara-CRd Consolidation (60-90 days post HCT)
~Cycles 3 and 4: Daratumumab 16 mg/kg every other week, days 1 and 15.
~Cycles 5-6:Daratumumab 16 mg/kg every other week, days 1 and 15. Schedule together with Carfilzomib and use scheduled dexamethasone as premed.
~Cycles 7-8: Daratumumab 16 mg/kg days 1 of each cycle."
16395266|NCT03556332|Procedure|autologous hematopoietic cell transplantation|High Dose Melphalan and Autologous Hematopoietic Cell Transplantation Patients will receive Melphalan 200 mg/m2 per institutional guidelines, or if over 70 years of age or creatinine >2mg/dL, they will receive 140 mg/m2.
16395267|NCT03556202|Drug|Mirikizumab|Administered SC
16395268|NCT03552796|Other|Pharmacokinetic Study|Correlative studies
16395269|NCT03552796|Biological|Recombinant EphB4-HSA Fusion Protein|Given intravesically
16395270|NCT03539575|Other|[11-C]OMAR|The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
16395273|NCT03533283|Drug|Glofitamab|Glofitamab will be administered through IV infusion every 3 weeks (Q3W) beginning Cycle 1, Day 1, for up to 17 cycles (Cycle = 21 days). Step-up dosing, in which an initial lower dose will be followed by a higher dose 1 week later, will be considered for the initial treatment phase and for Cycle 9 of the re-treatment phase.
16395274|NCT03533283|Drug|Atezolizumab|Atezolizumab will be administered in combination with Glofitamab through IV infusion Q3W from Cycle 2, Day 1, for up to 16 cycles (Cycle = 21 days).
16395275|NCT03533283|Drug|Obinutuzumab|Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.
16395276|NCT03533283|Drug|Tocilizumab|Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).
16395277|NCT03533283|Drug|Polatuzumab Vedotin|Polatuzumab vedotin will be administered in combination with Glofitamab (on different days) Q3W from Cycle 1, Day 2, for up to 12 cycles (Cycle = 21 days).
16395278|NCT03533283|Drug|89Zr-Df-IAB22M2C|Participants will receive 89Zr-Df-IAB22M2C (Cycle 1 only) prior to obinutuzumab pre-treatment and again on Day 10 after dosing with glofitamab, followed by PET/CT.
16395279|NCT03531853|Device|hand-held swept source optical coherence tomography|images the eye
16395280|NCT03524092|Drug|Mirikizumab|Administered SC
16395281|NCT03524092|Drug|Mirikizumab|Administered IV
16395282|NCT03524092|Drug|Placebo|Administered SC
16395283|NCT03519945|Drug|Mirikizumab|Administered SC.
16395284|NCT03518086|Drug|Mirikizumab|Administered IV
16395285|NCT03518086|Drug|Placebo|Administered IV
16395286|NCT03497507|Device|Sham bracelet|Patients will wear bracelets on both hands
16395287|NCT03497507|Device|Acupressure bracelet|Patients will wear bracelets on both hands.
16395365|NCT03155347|Drug|Tocilizumab|Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.
16395288|NCT03495921|Biological|Vigil|Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms.
16395289|NCT03495921|Drug|Irinotecan|Irinotecan injectable formulation will be obtained. This will be drawn up into oral syringes (1 cycle of 5 doses) and dispensed to the subject with instructions to refrigerate until administration. Irinotecan may be mixed with cranberry-grape juice immediately before administration to mask the bitter flavor and administered once daily on Days 1 through 5 of each 3-week cycle.
16395290|NCT03495921|Drug|Temozolomide|Temozolomide capsules may be opened and mixed in apple sauce or juice if unable to swallow whole capsules. Temozolomide is administered on Days 1 through 5 of each 3-week course and given at least 1 hour before Irinotecan.
16395291|NCT03495479|Drug|OMN54|Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator.
16395292|NCT03491176|Procedure|Biospecimen Collection|Undergo collection of blood samples
16395293|NCT03491176|Procedure|Magnetic Resonance Imaging|Undergo MRI scan
16395294|NCT03491176|Other|Quality-of-Life Assessment|Ancillary studies
16395295|NCT03491176|Other|Questionnaire Administration|Ancillary studies
16395296|NCT03456076|Drug|Alectnib|Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
16395297|NCT03456076|Drug|Cisplatin|"Participants will receive Cisplatin 75 milligrams per square meter (mg/m^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
16395298|NCT03456076|Drug|Vinorelbine|Participants will receive Vinorelbine 25 mg/m^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
16395299|NCT03456076|Drug|Gemcitabine|Participants will receive Gemcitabine 1250 mg/m^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
16395300|NCT03456076|Drug|Pemetrexed|"Participants will receive 500 mg/m^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
16395301|NCT03456076|Drug|Carboplatin|For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
16395302|NCT03451422|Drug|Efavaleukin Alfa|Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
16395303|NCT03451422|Drug|Placebo|The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
16395305|NCT03432286|Drug|Galcanezumab|Administered SQ
16395306|NCT03432286|Drug|Placebo|Administered SQ
16395307|NCT03427411|Drug|M7824|Flat dose of 1,200 mg of M7824 IV once every 2 weeks
16395314|NCT03422627|Drug|Efavaleukin Alfa|The phase 1b part of this study will be conducted as a multiple ascending dose (MAD) study. Each dosing cohort will consist of between 3 and 6 subjects who will receive efavaleukin alfa subcutaneously (SC) either every week or every 2 weeks plus protocol permitted background therapy for 52 weeks. At the discretion of the Sponsor, following discussion and agreement between the principal investigator and medical monitor, subjects responding to efavaleukin alfa (as assessed by the end of week 50), who wish to continue treatment, may continue to receive efavaleukin alfa treatment at their current dosing regimen for up to an additional 208 weeks through an extended dosing period. All subjects who continue to receive efavaleukin alfa during the extended dosing period will be reevaluated every 6 months for their response to treatment.
16395315|NCT03422627|Drug|Efavaleukin Alfa|All subjects will receive the recommended phase 2 dose (RP2D) of efavaleukin alfa for 52 weeks.
16395316|NCT03414983|Biological|Nivolumab|Specified dose on specified days
16395317|NCT03414983|Drug|Oxaliplatin|Specified dose on specified days
16395318|NCT03414983|Drug|Leucovorin|Specified dose on specified days
16395319|NCT03414983|Drug|Fluorouracil|Specified dose on specified days
16395320|NCT03414983|Drug|Bevacizumab|Specified dose on specified days
16395321|NCT03395236|Combination Product|"StellarexTM 0.014 Over-The-Wire Drug-coated Angioplasty Balloon"|"The Stellarex balloon (0.014) is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency."
16395541|NCT02301156|Drug|Ublituximab|Ublituximab IV infusion
16395322|NCT03388619|Radiation|Dose to prostate bed with integrated boost|Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed
16395323|NCT03388619|Radiation|Dose to prostate bed irradiation only|Radiation will be delivered to the prostate bed only
16395324|NCT03384940|Drug|DS-8201a|DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
16395325|NCT03383458|Biological|Nivolumab|Specified dose on specified days
16395326|NCT03383458|Other|Placebo|specified dose on specified days
16395327|NCT03363373|Biological|GM-CSF + Naxitamab|Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody
16395330|NCT03330821|Drug|Cytarabine|Given IV
16395331|NCT03330821|Drug|Idarubicin|Given IV
16395332|NCT03330821|Other|Laboratory Biomarker Analysis|Correlative studies
16395333|NCT03330821|Drug|Pevonedistat|Given IV
16395334|NCT03330821|Other|Pharmacological Study|Correlative studies
16395335|NCT03326804|Device|H1 Hip Resurfacing Arthroplasty|A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device
16395336|NCT03322280|Procedure|TACE combined with iodine-125 seeds implantation|Conventional TACE with lipiodol was performed. Then Iodine-125 seed implantation into PVTT is conducted 7-10 days after TACE when liver function tests demonstrated values comparable to those obtained before TACE.
16395337|NCT03322280|Procedure|TACE|Only conventional TACE with lipiodol and chemotherapy drugs was performed.
16395338|NCT03317223|Drug|CJ-12420/Clarithromycin/Amoxicillin|CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
16395339|NCT03304821|Drug|GM-CSF|Participants will self-administer 500 μg/day of GM-CSF, subcutaneously, three times per week (Monday, Wednesday, Friday) for three weeks. After three months the participants will receive a second administration of 500 μg/day of subcutaneous GM-CSF, three times per week for another 3 weeks and then will be followed for another 3 months.
16395340|NCT03304821|Drug|Placebo|Participants will self-administer 500 μg/day of a placebo, subcutaneously, three times per week (Monday, Wednesday, Friday) for three weeks. After three months the participants will receive a second administration of 500 μg/day of a placebo administered subcutaneously, three times per week for another 3 weeks and then will be followed for another 3 months.
16395341|NCT03287752|Device|BASKA MASK|Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant
16395342|NCT03287752|Device|Endotracheal tube|Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.
16395343|NCT03260491|Drug|U3-1402|U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)
16395344|NCT03252847|Genetic|AAV2/5-RPGR|Open label, non-randomised, dose-escalation intervention followed by randomised dose confirmation against a control arm
16395345|NCT03245645|Other|Dietary Intervention|Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis. This study will focus on fructose, which is one of the main components of FODMAP (Fermentable oligosaccharides, dissacharides, mono-saccharides and polyols) foods. Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans. FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria. Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
16395346|NCT03233724|Drug|Decitabine (DAC)|Administered orally on two consecutive days (preferably Tuesday and Wednesday) for two weeks out of three weeks x 9 weeks
16395347|NCT03233724|Drug|Tetrahydrouridine (THU)|Administered orally on two consecutive days (preferably Tuesday and Wednesday) for two weeks out of three weeks x 9 weeks
16395348|NCT03233724|Drug|Pembrolizumab|200 mg IV once a day every Wednesday, Thursday or Friday every 3 weeks.
16395349|NCT03222648|Other|Structured Responsive Exercise Training|Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)
16395350|NCT03222648|Other|Usual Care|Continuation of usual care
16395351|NCT03219333|Drug|Enfortumab vedotin|Intravenous (IV) infusion on days 1, 8 and 15 every 28 days
16395352|NCT03207035|Procedure|Axillary brachial plexus block|Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine
16395353|NCT03185819|Drug|Intranasal Placebo|Participants will receive placebo as intranasal dose to match intranasal esketamine.
16395354|NCT03185819|Drug|Midazolam Placebo Solution|Participants will receive placebo as oral dose to match midazolam drug.
16395355|NCT03185819|Drug|Midazolam|Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
16395356|NCT03185819|Drug|Esketamine|Participants will receive esketamine at a dose of 28 mg as intranasal solution.
16395357|NCT03185819|Drug|Esketamine|Participants will receive esketamine at a dose of 56 mg as intranasal solution.
16395358|NCT03185819|Drug|Esketamine|Participants will receive esketamine at a dose of 84 mg as intranasal solution.
16395359|NCT03179631|Drug|Ataluren|10, 20 mg/kg
16395360|NCT03179631|Drug|PLACEBO|10, 20 mg/kg
16395361|NCT03170518|Drug|Canagliflozin 100 mg|Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
16395362|NCT03170518|Drug|Canagliflozin 300 mg|Canagliflozin 300 mg tablet will be administered orally once-daily.
16395363|NCT03170518|Drug|Placebo|Matching placebo tablet will be administered orally once-daily.
16395364|NCT03157128|Drug|LOXO-292|Oral LOXO-292
16395366|NCT03155347|Drug|MTX|Participants will receive MTX stable doses at 10 to 25 mg orally.
16395368|NCT03155347|Drug|Placebo Matched to Tocilizumab|Placebo matched to tocilizumab.
16395369|NCT03154749|Drug|DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)|All eligible patients were randomly assigned at a 1:1 ratio to the experimental arm (docetaxel (75 mg/m2 administered intravenously every 3 weeks) plus carboplatin (AUC 6 mg/mL per min, intravenously every 3 weeks) for six cycles) or the standard treatment arm (epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles).
16395370|NCT03141177|Biological|Nivolumab|Specified dose on specified day
16395371|NCT03141177|Drug|Cabozantinib|Specified dose on specified days
16395372|NCT03141177|Drug|Sunitinib|Specified dose on specified days.
16395373|NCT03141177|Biological|Ipilimumab|Specified dose on specified days
16395374|NCT03138512|Biological|nivolumab|Specified dose on specified days
16395375|NCT03138512|Biological|ipilimumab|Specified dose on specified days
16395376|NCT03138512|Drug|nivolumab placebo|Specified dose on specified days
16395377|NCT03138512|Drug|ipilimumab placebo|Specified dose on specified days
16395378|NCT03136731|Diagnostic Test|Celiac disease antibody screening|Observational parameters
16395379|NCT03129126|Drug|LP-10|Intravesical tacrolimus
16395384|NCT03084523|Drug|Ferumoxytol Injectable Product|Patients will be administered a single dose of ferumoxytol as an MRI contrast
16395385|NCT03083665|Drug|Placebo|"Pharmaceutical form: Film-coated tablets
~Route of administration: Oral use"
16395386|NCT03083665|Drug|Brivaracetam|"Pharmaceutical form: Film-coated tablets
~Concentration: 25 mg tablets and 50 mg tablets
~Route of administration: Oral use"
16395390|NCT03055416|Other|Mobile Men App Prototype|Testing of app functionality
16395391|NCT03052920|Device|Cochlear implant|Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
16395392|NCT03049462|Drug|Mirabegron|Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.
16395393|NCT03049462|Other|B Complex Plus Vitamin C Tablets|Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).
16395394|NCT03036098|Biological|Nivolumab|Specified Dose on Specified Days
16395395|NCT03036098|Biological|Ipilimumab|Specified Dose on Specified Days
16395396|NCT03036098|Drug|Gemcitabine|Specified Dose on Specified Days
16395397|NCT03036098|Drug|Cisplatin|Specified Dose on Specified Days
16395398|NCT03036098|Drug|Carboplatin|Specified Dose on Specified Days
16395399|NCT03030417|Drug|LMP744|Indenoisoquinolines, such as LMP744, are potent inhibitors of the enzyme topoisomerase I (Top1). Top1 is necessary for transcription, replication, recombination, and the repair of double-strand DNA breaks. It relaxes the supercoiled DNA by introducing a single-strand break, generating a free strand that rotates around the Top1-bound DNA complex. In the absence of external triggers, Top1-DNA cleavage complexes are generally short lived. Top1 inhibitors are potent anticancer agents because they stabilize the formation of the Top1-DNA cleavage complex in tumor cells, which induces DNA damage, delays DNA repair, and results in cell cycle arrest and apoptosis. LMP744 exhibited antitumor activity with lower toxicity than other agents in preclinical studies. Treatment of patients with LMP744 is expected to reduce tumor burden at doses that are well-tolerated.
16395400|NCT03023683|Biological|FluMist®|Influenza Virus Vaccine Live, Intranasal Spray
16395401|NCT03020472|Biological|2008-2009 FluMist LAIV (Intranasal)|2008-2009 FluMist vaccine delivered intranasally
16395402|NCT02992743|Drug|letetresgene autoleucel (GSK3377794)|Letetresgene autoleucel (GSK3377794) as an IV infusion.
16395403|NCT02992743|Drug|Cyclophosphamide|Cyclophosphamide will be used as a lymphodepleting chemotherapy.
16395404|NCT02992743|Drug|Fludarabine|Fludarabine will be used as a lymphodepleting chemotherapy.
16395405|NCT02988128|Device|Treatment for intracranial aneurysms|Embolization of aneurysms
16395406|NCT02988128|Device|Treatment for Acute Ischemic Stroke|Revascularization of an intracranial blood vessel
16395407|NCT02985957|Biological|Nivolumab|Specified dose on specified days
16395408|NCT02985957|Biological|Ipilimumab|Specified dose on specified days
16395409|NCT02985957|Drug|Cabazitaxel|Specified dose on specified days
16395410|NCT02985957|Drug|Prednisone|Specified dose on specified days
16395411|NCT02983006|Biological|DS-8273a|"Starting Dose: 4 mg/ kg IVQ 3 weeks (Cohort 1)
~Dose Escalation: 8 mg/kg IV Q 3 weeks (Cohort 2), 16 mg/kg IV Q 3 weeks (Cohort 3), 24 mg/kg IV Q 3 weeks (Cohort 4), 2 mg/kg IV Q 3 weeks (Cohort -1), 4 mg/kg IV Q 3 weeks (Cohort -2)"
16395412|NCT02983006|Biological|Nivolumab|5 mg/kg IV Q 3 weeks
16395414|NCT02960022|Drug|enzalutamide|Subjects will receive enzalutamide orally once daily at the same time each day.
16395415|NCT02960022|Drug|abiraterone acetate|Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
16395416|NCT02960022|Drug|prednisone|Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
16395417|NCT02949830|Drug|givosiran (ALN-AS1)|givosiran by subcutaneous (SC) injection
16395418|NCT02939820|Drug|patisiran (ALN-TTR02)|patisiran (ALN-TTR02) administered by intravenous (IV) infusion
16395419|NCT02936687|Drug|NOS Inhibition|NOS inhibition: L - NMMA is a potent non-selective NOS inhibitor used to study vascular physiology. L-NMMA will be infused at 3 mg/kg body weight/hr bolus (over 10min ) followed by a maintenance infusion of 1 mg/kg/hr for the duration of the experiment. Systemic delivery of L - NMMA has been shown to elevate blood pressure ~8-15 mmHg that is within the range observed during exercise.
16395420|NCT02936687|Drug|ET-1 Inhibition|ET-1 inhibition: Ambrisentan is an antagonist of the ETA receptor. Subjects will receive 10 mg of Ambrisentan in a pill form 90-150 minutes prior to the OGTT. This class of drugs have been used to research ET-1 signaling in diabetes, obesity, and hypertension. ETA receptors are the most likely to mediate excessive constriction in MetSyn patients. Ambrisentan will be taken orally. Systemic delivery of endothelin antagonist have been shown at chronic dosing to decrease systolic blood pressure 4.5±10 mmHg and diastolic 3 ± 7.5 mmHg in hypertensives, and not alter mean arterial pressure in obesity.
16395421|NCT02936687|Drug|NOS Inhibition Placebo|Saline will be infused at the same rate and quantity as the corresponding drug visit.
16395422|NCT02936687|Device|3 Tesla MRI|A 3 Tesla MRI will be used to quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits (at baseline and during treatment conditions).
16395423|NCT02936687|Device|Intravenous Catheter|A blood sampling IV catheter will be used to draw up to 15 mL blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin as well as for markers of inflammation and oxidative stress.
16395424|NCT02936687|Other|Oral Glucose Tolerance Test|The subject will drink distilled deionized water (300ml) containing 75 grams glucose within 5 minutes.
16395425|NCT02936687|Drug|ET-1 Inhibition Placebo|Placebo pill similar in size and shape to Ambrisentan will be used as placebo control.
16395426|NCT02922816|Biological|Fecal Microbiota Transplant (FMT)|The Fecal Microbiota Transplant (FMT) using Allogeneic human stool in glycerol (10%) (AHSG) intervention will be administered via rectal retention enema and performed in either an inpatient or outpatient clinic.
16395427|NCT02922816|Procedure|Bowel preparation|Trial participants will undergo the bowel preparation by taking magnesium citrate the day before the cycle begins (Day -1).
16395428|NCT02922816|Procedure|Stool or perirectal swab sampling|Stool or perirectal swabs will be collected at screening (for eligibility determination) and Days 1, 2, 15, and 36 of each cycle.
16395429|NCT02922816|Other|Fasting|In Cycle 1 and Cycle 2, participants cannot consume food, alcohol, or other liquids on Day 1 prior to the intervention. Trial participants will not be fasting on Day 1 of Cycle 0.
16395430|NCT02907398|Device|Inspire therapy|
16395431|NCT02907398|Other|No intervention|
16395432|NCT02895451|Behavioral|Extended behavioral intervention|The exercise goal is set in liaison between the patient and the physiotherapist, based on activities and target behaviors that the patient thinks is relevant and important. The patients are asked to self-monitor the defined exercise goal by completing an exercise diary. The exercise diary includes specification of the performed exercise dose (frequency, intensity and duration). The exercise diary is followed up by a physiotherapist every third week by a phone call or a personal meeting. Visual feed-back on the performed dose of exercise is given once by accelerometry. At end of intervention (16 weeks) the patient is offered a follow-up meeting with the physiotherapist to discuss a long-term exercise goal.
16395433|NCT02859168|Behavioral|Myofascial Induction|Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.
16395434|NCT02859168|Device|Unplugged pulsed shortwave therapy|Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.
16395439|NCT02809716|Other|Biomarker Analysis|Correlative studies
16395440|NCT02809716|Other|Cytology Specimen Collection Procedure|Undergo collection of blood and tissue samples
16395441|NCT02803437|Drug|Radium-223 dichloride (Xofigo, BAY 88-8223)|Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.
16395442|NCT02787590|Drug|Simvastatin|
16395443|NCT02787590|Drug|Matched Placebo (for Simvastatin)|
16395444|NCT02784600|Device|Bioinductive implant|
16395447|NCT02782104|Drug|Esketamine Nasal Spray|Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.
16395542|NCT02301156|Drug|ibrutinib|Ibrutinib oral daily dose
16395450|NCT02768701|Drug|Pembrolizumab|Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion.
16395451|NCT02768701|Drug|Cyclophosphamide|A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study.
16395452|NCT02752035|Drug|gilteritinib|Tablet, oral
16395453|NCT02752035|Drug|azacitidine|Subcutaneous injection or intravenous infusion
16395454|NCT02740114|Drug|Bupivacaine|150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.
16395455|NCT02740114|Drug|Liposomal Bupivacaine|266 mg injected on each side of the wound at the end of surgery before wound closure.
16395456|NCT02740114|Drug|Oxycodone|1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
16395457|NCT02740114|Behavioral|Pill Diary|Participants complete a pill diary every day for 30 days after hospital discharge.
16395458|NCT02740114|Behavioral|Symptom Questionnaire|Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
16395459|NCT02736565|Biological|pbi-shRNA™ EWS/FLI1 Type 1 LPX|
16395460|NCT02734004|Drug|Olaparib|Olaparib
16395461|NCT02734004|Drug|MEDI4736|MEDI4736
16395462|NCT02734004|Drug|Bevacizumab|Bevacizumab
16395463|NCT02678143|Drug|Alemtuzumab|
16395464|NCT02678143|Drug|Cyclophosphamide|
16395465|NCT02678143|Drug|Mycophenolate mofetil|
16395466|NCT02678143|Drug|Sirolimus|
16395467|NCT02678143|Drug|Fludarabine|
16395468|NCT02678143|Radiation|Total body irradiation|
16395469|NCT02678143|Procedure|Hematopoietic stem cell transplant|
16395470|NCT02669212|Diagnostic Test|MRI Radiofrequency Coils|MRI scans are performed on FDA- approved scanners with approved radiofrequency coils, and their use conforms to the corresponding FDA labels. These studies may involve software modifications as allowed under 21 CFR 812.2(b)(4).
16395471|NCT02669212|Diagnostic Test|TMS|Conventional TMS studies in this protocol are considered non- significant risk (NSR) devices and will only be used within published guidelines.
16395472|NCT02659813|Device|Orthodontic archwire|Archwire used to align teeth in an orthodontic fixed brace
16395473|NCT02658890|Drug|BMS-986205|
16395474|NCT02658890|Drug|Nivolumab|
16395475|NCT02658890|Drug|Ipilimumab|
16395479|NCT02632994|Drug|LY2503029|Administered orally.
16395480|NCT02632994|Drug|LY3023414|Administered orally.
16395481|NCT02629120|Drug|Alentuzumab (Campath)|Transplant Conditioning Drug: Monoclonal antibody that targets recipient and donor T-cells to prevent graft verses host disease. Not an IND. This is a well studied drug, and is not under an IND.
16395482|NCT02629120|Drug|Busulfan IV|Transplant Conditioning Drug: Chemotherapy to create space in the patient's bone marrow so that the donor peripheral blood stem cells can repopulate in the patient's bone marrow. This is a well studied drug, and is not under an IND.
16395483|NCT02629120|Drug|Sirolimus|Immunosuppressant to prevent donor peripheral blood stem cell rejection and graft versus host disease. This is a well studied drug, and is not under an IND.
16395484|NCT02629120|Drug|Cyclophosphamide|Post transplant cyclophosphamide given to prevent graft verses host disease. This is a well studied drug, and is not under an IND.
16395485|NCT02629120|Radiation|Total Body Irradiation|Transplant Conditioning Total Body Radiation (300cGy in 2 fractionated doses), given only to patient receiving matched unrelated donor cells, to create space in the patient's bone marrow so that the donor peripheral blood stem cells can repopulate in the patient's bone marrow.
16395486|NCT02629120|Biological|Peripheral blood stem cells|Donor Peripheral blood stem cells, either matched unrelated donor or matched related relative to replace the patient's immune cells with functional immune cells. The peripheral blood stem cells are not regulated by the FDA.
16395487|NCT02621021|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg /day over 1 hour X 2 days.
16395488|NCT02621021|Drug|Fludarabine|Days -7 to -3, Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days.
16395489|NCT02621021|Drug|Aldeslaukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).
16395490|NCT02621021|Drug|Pembrolizumab|(Cohort 1, Arm 2 and Cohort 2) On day -2, and days 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days) following cell infusion: Pembrolizumab 2mg/kg IV over approximately 30 minutes. (Cohort 1, Arm 1 Retreatment) 4 doses every 3 weeks (+/- 2 days): Pembrolizumab 2mg/kg IV over approximately 30 minutes.
16395491|NCT02621021|Biological|young TIL|Day 0: Cells will be administered intravenously (IV) on the Patient Care Unit over 20-30 minutes.
16395492|NCT02594111|Drug|Colchicine vs Placebo|Colchicine vs Placebo 1.8 mg PO over 1 hour
16395493|NCT02593123|Drug|mycophenolate mofetil|Given PO, by mouth, orally or IV, intravenous medication administration.
16395494|NCT02593123|Biological|Sargramostim|"GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
~Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis.
~Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF."
16395495|NCT02593123|Biological|Filgrastim|G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
16395496|NCT02566863|Drug|Dexmedetomidine|1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes.
16395497|NCT02544217|Drug|KH176|
16395498|NCT02544217|Drug|placebo|
16395505|NCT02531880|Drug|Mangafodipir|Patients will be imaged interictally with a gadolinium enhanced MRI session. The administration of mangafodipir will be done as an inpatient during long-term video EEG recording, to ensure administration in the peri-ictal period.
16395506|NCT02527343|Drug|volanesorsen|300 mg of volanesorsen administered subcutaneous (SC) injection, once-weekly (QW).
16395507|NCT02527343|Drug|Placebo|Volanesorsen-matching placebo administered SC injection.
16395508|NCT02510261|Drug|Patisiran (ALN-TTR02)|administered by intravenous (IV) infusion
16395509|NCT02488408|Drug|Bemcentinib|
16395510|NCT02488408|Drug|Cytarabine|
16395511|NCT02488408|Drug|Decitabine|
16395512|NCT02458560|Device|Edwards CENTERA Self-Expanding Transcatheter Heart Valve|The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
16395513|NCT02454517|Behavioral|Behavioral Dietary Intervention|Undergo DPP lifestyle intervention
16395514|NCT02454517|Behavioral|Exercise Intervention|Undergo DPP lifestyle intervention
16395515|NCT02454517|Other|Informational Intervention|Receive oral and written guidelines and meet with dietician
16395516|NCT02454517|Other|Laboratory Biomarker Analysis|Correlative studies
16395517|NCT02454517|Other|Quality-of-Life Assessment|Ancillary studies
16395518|NCT02454517|Other|Questionnaire Administration|Ancillary studies
16395519|NCT02452840|Other|No Intervention|No Intervention
16395520|NCT02449837|Other|Blood draw|Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
16395521|NCT02425891|Drug|Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody|Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
16395522|NCT02425891|Drug|Nab-Paclitaxel|Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
16395523|NCT02425891|Drug|Placebo|Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
16395524|NCT02424617|Drug|erlotinib|erlotinib is used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).
16395525|NCT02424617|Drug|bemcentinib|Bemcentinib is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor which is connected with poor prognosis and acquired resistance to therapy.
16395529|NCT02346747|Biological|Vigil|bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy
16395530|NCT02346747|Biological|Placebo|"freeze media."
16395531|NCT02315612|Biological|CD22-CAR|CD22-CAR cells will be infused on Day 0 after induction chemotherapy regimen.
16395534|NCT02310321|Drug|gilteritinib|Once-daily oral administration on 14 consecutive days in every cycle in each period.
16395535|NCT02310321|Drug|Idarubicin|Induction period: Once-daily intravenous injection of 12 mg/m^2 idarubicin on 3 consecutive days.
16395536|NCT02310321|Drug|Cytarabine|"Induction period: Once-daily intravenous injection of 100 mg/m^2 cytarabine on 7 consecutive days.
~Consolidation period: Twice-daily intravenous injection of 1.5 g/m^2 cytarabine on Days 1, 3, and 5."
16395537|NCT02307812|Drug|Ramucirumab|Administered intravenously (IV)
16395538|NCT02307812|Drug|Paclitaxel|Administered IV
16395539|NCT02304757|Drug|99Tc-MDP|99Tc-MDP, H20000218
16395543|NCT02296307|Other|Blood test: CA-125 biomarker|"CA-125 biomarker blood test at visit 1, day 1.
~CA-125 biomarker blood test at visit 2, week 6."
16395544|NCT02296307|Other|Second Test: Transvaginal Ultrasound|-Transvaginal Ultrasound at visit 1, day 1.
16395545|NCT02296307|Other|Follow-up phone call|Phone call 6 months after last visit to verify continued health.
16395546|NCT02283996|Other|Physical Therapy|"The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions.
~Brigham and Women's/Massachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis:
~http://www.brighamandwomens.org/Patients_Visitors/pcs/rehabilitationservices/Physical%20Therapy%20Standards%20of%20Care%20and%20Protocols/Shoulder%20-%20Adhesive%20capsulitis.pdf"
16395547|NCT02283996|Drug|Depot Methylprednisolone|40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine
16395566|NCT02188745|Drug|17B-estradiol|Anti-estrogen
16395567|NCT02188745|Drug|Letrozole|Aromatase inhibitors work by blocking estrogen receptors; they stop a key enzyme (called aromatase) from changing other hormones into estrogen. This lowers estrogen levels in the body, taking away the fuel that estrogen receptor-positive breast cancers need to grow.
16395568|NCT02188745|Drug|Anastrozole|Aromatase inhibitors work differently from tamoxifen and raloxifene. Instead of blocking the estrogen receptors, they stop a key enzyme (called aromatase) from changing other hormones into estrogen. This lowers estrogen levels in the body, taking away the fuel that estrogen receptor-positive breast cancers need to grow.
16395569|NCT02188745|Drug|Exemestane|Aromatase inhibitors work differently from tamoxifen and raloxifene. Instead of blocking the estrogen receptors, they stop a key enzyme (called aromatase) from changing other hormones into estrogen. This lowers estrogen levels in the body, taking away the fuel that estrogen receptor-positive breast cancers need to grow.
16395570|NCT02178800|Drug|GSK1265744 Tablets|30-mg tablets, taken orally
16395571|NCT02178800|Drug|Injectable GSK1265744|"Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
~Cohort 2: 600-mg injection, administered as one IM gluteal injection"
16395572|NCT02178800|Drug|Placebo for GSK1265744 Tablets|Taken orally
16395573|NCT02178800|Drug|Injectable Placebo for GSK1265744|"Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
~Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection"
16395574|NCT02160691|Device|Anxiety Meter|This is a new device developed to measure changes in heart rate and translate these into a visual display of arousal level in children with autism spectrum disorder.
16395575|NCT02135419|Drug|imiquimod|Applied topically
16395576|NCT02135419|Drug|fluorouracil|Applied topically
16395577|NCT02135419|Device|infrared photocoagulation therapy|Undergo infrared coagulation
16395578|NCT02135419|Device|thermal ablation therapy|Undergo hyfrecation/electrocautery therapy
16395579|NCT02135419|Device|laser therapy|Undergo laser therapy
16395580|NCT02135419|Other|clinical observation|Undergo active monitoring
16395581|NCT02135419|Other|laboratory biomarker analysis|Correlative studies
16395582|NCT02134184|Biological|Fluzone® 2012-2013 Formula NDC No 498281-012-50|This vaccine is given intramuscularly
16395583|NCT02110888|Device|Subcutaneous peripheral nerve stimulation|
16395584|NCT02110888|Other|SCS Only|
16395585|NCT02108652|Drug|Atezolizumab|Atezolizumab 1200 mg given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria/loss of clinical benefit or unmanageable toxicity.
16395588|NCT02085460|Drug|Placebo|
16395589|NCT02085460|Drug|2% Rebamipide liquid|
16395590|NCT02085460|Drug|4% Rebamipide liquid|
16395591|NCT02065765|Biological|Ramucirumab|Administered intravenously (IV)
16395592|NCT02060188|Drug|Ipilimumab|
16395593|NCT02060188|Drug|Nivolumab|
16395594|NCT02060188|Drug|Cobimetinib|
16395595|NCT02060188|Drug|Daratumumab|
16395596|NCT02060188|Drug|anti-LAG-3 antibody|
16395597|NCT02051218|Drug|Denosumab (reduced dosing)|3x Denosumab 120mg (XGEVA®) sc. q4w followed by Denosumab 120mg (XGEVA®) sc. q12w
16395598|NCT02051218|Drug|Denosumab (standard dosing)|Denosumab 120mg (XGEVA®) sc. q4w
16395599|NCT02043678|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles
16395600|NCT02043678|Drug|Matching placebo (normal saline)|Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles
16395601|NCT02043678|Drug|Abiraterone|1000 mg once daily, oral, with best supportive care
16395602|NCT02043678|Drug|Prednisone/Prednisolone|5 mg twice daily, oral, with best supportive care
16395603|NCT02040298|Drug|Clemastine|4mg tablet twice daily
16395604|NCT02040298|Drug|Placebo|Placebo tablet twice daily
16395605|NCT02038998|Device|Exer-Rest® TL|Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
16395606|NCT02034409|Device|Pulsed Low Intensity Ultrasound|20 minutes daily for 48 weeks
16395607|NCT02034409|Device|Sham Comparator|20 minutes daily for 48 weeks
16395608|NCT02029443|Drug|acalabrutinib|
16395611|NCT01985360|Procedure|Cardiac Catheterization|Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
16395612|NCT01985360|Procedure|Coronary Artery Bypass Graft Surgery|"Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said cabbage). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart."
16395613|NCT01985360|Procedure|Percutaneous Coronary Intervention|Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
16395614|NCT01985360|Behavioral|Lifestyle|Diet, physical activity, smoking cessation
16395615|NCT01985360|Drug|Medication|antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
16395616|NCT01983345|Procedure|prenatal surgical repair of fetal myelomeningocele|open surgical repair of myelomeningocele before 26 weeks gestational age
16395617|NCT01972217|Drug|Olaparib|Olaparib bid
16395618|NCT01972217|Drug|Placebo|Placebo bid
16395619|NCT01972217|Drug|Abiraterone|Abiraterone 1000 mg
16395620|NCT01972217|Drug|Prednisone or prednisolone|Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study.
16395621|NCT01956708|Procedure|RIPC|3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
16395622|NCT01939353|Drug|CTN SR|CTN SR tablets
16395623|NCT01939353|Drug|Placebo|CTN SR-matching placebo tablets
16395624|NCT01909453|Drug|LGX818|LGX818- Orally 100 mg and 50 mg capsules
16395625|NCT01909453|Drug|MEK162|MEK162- Orally 15 mg tablets
16395626|NCT01909453|Drug|vemurafenib|Tablets in bottles or blisters 240 mg
16395627|NCT01871571|Biological|bevacizumab|Given IV
16395628|NCT01871571|Drug|oxaliplatin|Given IV
16395629|NCT01871571|Drug|leucovorin calcium|Given IV
16395630|NCT01871571|Drug|fluorouracil|Given IV
16395631|NCT01871571|Other|laboratory biomarker analysis|Correlative studies
16395633|NCT01857856|Drug|Eplerenone|eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day
16395634|NCT01854554|Radiation|IMPT|IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
16395635|NCT01854554|Radiation|IMRT|IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
16395636|NCT01854554|Behavioral|Cognitive Tests|Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.
16395637|NCT01854554|Behavioral|Questionnaires|Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.
16395639|NCT01806129|Other|educational intervention|Undergo reproductive health program
16395640|NCT01806129|Other|questionnaire administration|Ancillary studies
16395641|NCT01806129|Procedure|quality-of-life assessment|Ancillary studies
16395642|NCT01797159|Radiation|Hippocampal-sparing Prophylactic Cranial Irradiation|Hippocampal-sparing Prophylactic Cranial Irradiation
16395643|NCT01724580|Drug|Baricitinib|Administered orally
16395644|NCT01660451|Drug|Copanlisib (Aliqopa, BAY80-6946)|"BAY 80-6946 is administered in a normal saline solution, 100 mL, intravenously over 1h. No intravenous glucose preparations should be administered on the days of infusion. Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).
~Part A: The individual dose will be 0.8 mg/kg (max. 65 mg) per infusion from Cycle 1 on. The maximum dose of 65 mg should never be exceeded.
~Part B: The individual dose will be 60 mg per infusion from Cycle 1 on."
16395645|NCT01622322|Drug|Nitrous Oxide|Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
16395646|NCT01622322|Other|oxygen|Subjects will receive General anesthesia: (Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
16395737|NCT00114738|Biological|EPOCH|EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.
16395738|NCT00114738|Drug|Bortezomib (B)|Bortezomib is given alone for one cycle.
16395648|NCT01609634|Other|Test Product|Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
16395649|NCT01609634|Other|Control Product 1|Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
16395650|NCT01609634|Other|Control Product 2|Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
16395651|NCT01573429|Other|deuterated-Bisphenol A (d-BPA)|The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or a carboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.
16395652|NCT01562223|Other|motexafin gadolinium|
16395657|NCT01445509|Drug|Bevacizumab|Once the MTD of dasatinib with bevacizumab 5 mg/kg IV every two weeks is determined, one final dose level will be accrued with that MTD dose of dasatinib with bevacizumab at 10 mg/kg IV every two weeks in order to determine if we can safely escalate bevacizumab to full dose with dasatinib concurrently.
16395658|NCT01445509|Drug|Dasatinib|We will start dasatinib at 50 mg PO QD which is less than half the recommended Phase 2 dose as well as bevacizumab at 5 mg/kg IV every two weeks, which is half the single agent dose. If this is well-tolerated, study drugs will be escalated per schema to maximize the dose of dasatinib when given concurrently.
16395659|NCT01436227|Other|Laboratory Biomarker Analysis|Correlative studies
16395660|NCT01436227|Drug|Pazopanib Hydrochloride|Given PO
16395661|NCT01417546|Drug|NHS-IL-12|NHS-IL12 is an investigational agent supplied to investigators by the manufacturer EMD Serono, Inc.
16395663|NCT01356628|Drug|PD-0332991|PD-0332991, 125mg, 3 cycles
16395669|NCT01309230|Biological|Vigil™|intradermal autologous Vigil™ (1.0 x 10^7 cells/injection; maximum of 12 vaccinations)
16395670|NCT01306045|Drug|AZD6244|75 mg bid po
16395671|NCT01306045|Drug|MK-2206|200 mg qd po
16395672|NCT01306045|Drug|Lapatinib|1500 mg qd po
16395673|NCT01306045|Drug|Erlotinib|150 mg qd po
16395674|NCT01306045|Drug|Sunitinib|50 mg qd po
16395675|NCT01306045|Procedure|Molecular Profiling|Molecular profiling of tumor tissue
16395676|NCT01295944|Drug|Carboplatin|Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued.
16395677|NCT01295944|Drug|Bevacizumab|Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, bevacizumab may be continued at the discretion of the treating physician.
16395680|NCT01174121|Biological|Young TIL|Day 0, cells will be infused intravenously 9IV) on the Patient Care Unit over 20 - 30 minutes (one to four days after the last dose of fludarabine).
16395681|NCT01174121|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum of 12 doses.)
16395682|NCT01174121|Drug|Cyclophosphamide|Days -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W Mesna 15mg/kg/day x2 days over 1 hr.
16395683|NCT01174121|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days.
16395684|NCT01174121|Drug|Pembrolizumab (Keytruda)|"Arm 3: Pembrolizumab 2mg /kg IV over approximately 30 minutes on Days -2, 21, 42, and 63
~Arm 4:
~Pembrolizumab 2mg /kg IV over approximately 30 minutes (for patients who meet progressive disease per RECIST criteria and have resolved major toxicities after cell infusion or anytime during the post-treatment evaluation period; starting within 4 weeks of progression; may receive up to 8 doses every 3 weeks)."
16395687|NCT01130519|Drug|Bevacizumab|Commercially available. Administered by intravenous infusion.
16395688|NCT01130519|Drug|Erlotinib|Commercially available. Administered orally.
16395689|NCT01087294|Procedure|Allogeneic stem cell transplant|Allogeneic stem cell transplant
16395739|NCT00114738|Drug|Bortezomib|Bortezomib is given with EPOCH and rituximab every 6 weeks for 12 cycles.
16395690|NCT01087294|Biological|Anti-CD19-chimeric-antigen-receptor-transduced T cells|"Patients receive T cells genetically engineered to express an anti-CD19 CAR. The cells are cultured in media containing IL-21, IL-7, and TWS119.
~TWS119 is a glycogen synthase 3 inhibitor"
16395691|NCT01087294|Procedure|Leukapheresis|Donors will undergo leukapheresis
16395692|NCT01065454|Drug|Riociguat (Adempas, BAY63-2521)|up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
16395693|NCT01065454|Drug|Riociguat (Adempas, BAY63-2521)|up to 1 mg three times a day (increasing from 0.5 to 1 mg)
16395694|NCT01065454|Drug|Riociguat (Adempas, BAY63-2521)|fixed 0.5 mg three times a day
16395695|NCT01065454|Drug|Placebo|Placebo three times a day
16395696|NCT01063517|Drug|olaparib|100mg BID oral tablet continuous
16395697|NCT01063517|Drug|paclitaxel|iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
16395698|NCT01063517|Drug|Placebo|100mg BID oral tablet to match olaparib tablet
16395699|NCT01061840|Biological|Vigil™|Patients will be treated once a month as long as sufficient material is available for up to 12 doses
16395700|NCT01061840|Biological|Vigil™|Patients will be treated once a month as long as sufficient material is available for up to 12 doses
16395701|NCT01061840|Biological|Vigil™|Patients will be treated once a month as long as sufficient material is available for up to 12 doses
16395702|NCT01060254|Drug|Placebo|Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 12 wks
16395703|NCT01060254|Drug|JNJ-42160443|Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use. One injection of 9 mg of JNJ-42160443 every 28 days for up to 12 wks
16395706|NCT00982111|Drug|Pemetrexed|500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
16395707|NCT00982111|Drug|Cisplatin|75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
16395708|NCT00982111|Biological|Necitumumab|800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
16395711|NCT00972309|Biological|TARP peptide vaccine|Will receive an admixture of the wildtype and epitopeenhanced TARP peptides emulsified with Montanide ISA 51 VG and GM-CSF. TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96
16395712|NCT00972309|Biological|TARP dendritic cell vaccine|Will receive peptidepulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
16395717|NCT00803465|Drug|Fluticasone Propionate 0.05% Cream-Reference Product|Small amount applied and evaluated over the course of two days
16395718|NCT00803465|Drug|Fluticasone Propionate 0.05% Cream-Test product|Small amount applied and evaluated over the course of two days
16395719|NCT00803166|Drug|Halobetasol Propionate 0.05% Cream-Reference Product|Small amount applied and evaluated over the course of three days
16395720|NCT00803166|Drug|Halobetasol Propionate 0.05% Cream-Test product 1|Small amount applied and evaluated over the course of three days
16395721|NCT00803166|Drug|Halobetasol Propionate 0.05% Cream-Test Product 2|Small amount applied and evaluated over the course of three days
16395722|NCT00800293|Drug|Betamethasone Dipropionate 0.05% Cream|Small amount applied and evaluated over the course of several hours
16395725|NCT00697073|Drug|Idebenone|Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day
16395727|NCT00471848|Drug|rabbit antithymocyte globulin|1.5 vials/10kg daily for 5 days
16395728|NCT00432523|Biological|M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®|
16395729|NCT00267904|Other|Coffee|Caffeinated coffee and decaffeinated coffee ingestion
16395730|NCT00267904|Other|Banana|Banana ingestion
16395731|NCT00267904|Other|Olives|Olives ingestion
16395732|NCT00267904|Other|Temp. manip.|Manipulate temperature at skin of the back
16395733|NCT00256776|Drug|Velcade (Bortezomib)|
16395734|NCT00256776|Drug|Thalidomide|
16395735|NCT00256776|Drug|Dexamethasone|
16395736|NCT00114738|Drug|Rituximab (R)|Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.
16395740|NCT00114738|Drug|Bortezomib or observation|At the beginning of Part C, patients are randomized to receive bortezomib maintenance or be observed w/o bortezomib.
16395741|NCT00112502|Drug|Celecoxib|400 mg orally twice a day continuous dosing
16395742|NCT00112502|Drug|Isotretinoin|40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
16395743|NCT00112502|Drug|Temozolomide|150 mg/m2 orally daily, 7 days on treatment, 7 days off.
16395744|NCT00112502|Drug|Thalidomide|400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
16395759|NCT00071708|Drug|Duloxetine Hydrochloride|
16395770|NCT05084521|Drug|Famotidine 400 mg/50 mL|Administration of a suspension of famotidine, 0.5 mg/kg/12h (with a maximum dose of 80 mg/day, regardless of the patient's weight) during 29 days.
16395771|NCT05084495|Diagnostic Test|Global peak atrial longitudinal strain and ECG|During the follow-up period the patient will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected
16395772|NCT05084482|Other|Prediction models|The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.
16395773|NCT05084469|Procedure|PET-MRI in pain-free remission period|Patients will performed PET-MRI scans. A first 30 minutes acquisition will be performed at time=60min after injection. A second 75 minutes acquisition will be performed at time=150min. Each scans will contain functional dynamic [18F]F13640 PET acquisition, anatomical and functional MRI images acquisition and pain evaluation using a score visual analogic scale.
16395774|NCT05084456|Drug|ModraDoc006/r|Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets in fed or fasting condition
16395776|NCT05084430|Drug|M032 & Prembrolizumab|Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.
16395777|NCT05084417|Other|N/A This is an observational study|As this is an observational study, there are no interventions assigned to either cohort.
16395778|NCT05084404|Drug|Experimental: 4 mg/day of WY-8678 (guanabenz acetate)|Patients with nonalcoholic fatty liver disease are administered 4 mg/day of WY-8678 (guanabenz acetate) twice daily for 16 weeks
16395779|NCT05084404|Drug|Experimental: 8 mg/day of WY-8678 (guanabenz acetate)|Patients with nonalcoholic fatty liver disease are administered 8 mg/day of WY-8678 (guanabenz acetate) twice daily for 16 weeks
16395780|NCT05084391|Device|stereotactic ablative radiotherapy (SABR)|is safe for treating heart arrhythmias (irregular heartbeat
16395781|NCT05084391|Other|Standard of Treatment|Standard of care
16395782|NCT05084378|Drug|Povidone-Iodine Lavage Solution|0.35% povidone-iodine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.35% povidone-iodine and sterile isotonic saline solution may also be used.
16395783|NCT05084378|Drug|Chlorhexidine Lavage Solution|0.05% chlorhexidine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.05% chlorhexidine and sterile isotonic saline may also be used.
16395784|NCT05084378|Drug|Topical Antibiotic|2 grams Vancomycin powder
16395785|NCT05084378|Drug|Saline Lavage Solution|1 litre of sterile isotonic saline
16395786|NCT05084365|Drug|Sulforaphane|Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
16395787|NCT05084365|Drug|Placebo|Placebo
16395788|NCT05084339|Diagnostic Test|CGM|blinded CGM used at 4 different time points in pregnancy
16395789|NCT05084326|Procedure|Engagement of fetal head as a predictor of a successful vaginal delivery|"In addition to the fetal lie, presentation, and position, the level or station of the presenting part in the maternal pelvis is an important factors in the labor process.
~In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section."
16395790|NCT05084313|Other|Manual Therapy|This group of patients will receive manual therapy techniques to harmonize vegetative nervous system. PPG and GSR will be recorded during the intervention. The techniques consist of suboccipital decompression, rib raising, diaphragm, larynx and mediastinum mobilisation, sternocleidomastoid muscle fascial release and occipito-mastoid suture release. All intervention is planned to take approximately 20 minutes.The group will include 40 healthy individuals.
16395791|NCT05084313|Other|Bio-feedback|Patients in this group will do slow paced breathing while getting visual and auditory feedback about their ppg and heart rate variability in a sitting position. The patients will be able to cease the session in case of feeling uncomfortable. The main purpose will be that the individuals should breath 6 breaths per minute to increase respiratory sinus arrhythmia which is also reflected at PPG waveforms and in reduction in GSR. The group will include 40 healthy individuals.
16395792|NCT05084313|Other|Control|Control group patients will be attached to the sensors and they will rest in a quiet and controlled indoor environment without any intervention. The aim of including this group is to to understand whether the parasympathetic effects expected in the manual therapy group were due to the intervention. The group will include 40 healthy individuals.
16395793|NCT05084300|Other|Pain Neuroscience Education|A total of 10 PNE sessions (Neuroscience pain education) will be carried out, two each week in addition medical treatment similar to control group (Usual care). The NPE sessions will be conducted by an experienced NPE certified physical therapist in 35 minute face-to-face group sessions. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
16395794|NCT05084300|Other|Usual care|The control group (Usual care) is treated with usual treatment, managment or medication for fibromyalgia, anxiolytics, antidepressants, analgesics. Depending on the medical needs and criteria of patients´s primary care physician.
16395795|NCT05084274|Behavioral|Lifestyle program|If the patient is allocated to the interventional group, the lifestyle modification program will be planned/started immediately after the intake at the fertility clinic. The lifestyle modification program has a duration of 12 weeks in which the subject will receive follow-up by the endocrinologist/diabetologist and dietitian to re-ceive an active dietary intervention plan, follow-up by the physiotherapist where sessions to start with physical exercise will be given. Monthly follow-up visits with the coordinating PCOS-midwife will be planned to enhance the subject's knowledge about PCOS and give emotional support. At the moment of randomization, the PCOS coordinating midwife will immediately plan all necessary appointments, with the endocrinologist and dietitian, physiotherapist and PCOS-coordinator, for the 12-week lifestyle program. This way, patients will have a clear overview of the following 12 weeks.
16395796|NCT05084261|Drug|BT051 200 mg|Oral BT051 200 mg once daily for 28 days.
16395797|NCT05084261|Drug|BT051 800 mg|Oral BT051 800 mg once daily for 28 days.
16395798|NCT05084261|Drug|BT051 3200 mg|Oral BT051 3200 mg once daily for 28 days.
16395799|NCT05084261|Drug|BT051 up to 3200 mg|Oral BT051 at a selected dose no greater than 3200 mg once daily for 28 days. Dose selected after completion of 200 mg, 800 mg and 3200 mg dose levels.
16395800|NCT05084261|Drug|Matching Placebo|Placebo Matching BT051
16395802|NCT05084235|Drug|Empagliflozin 10 MG|Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
16395803|NCT05084235|Drug|Placebo|Placebo matches the active drug in appearance, odor and labelling
16395804|NCT05084222|Drug|Buventol® Easyhaler® 200 µg/inhalation dmDPI|Two doses will be administered
16395805|NCT05084222|Drug|Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI|Two doses will be administered
16395806|NCT05084222|Drug|Ventoline® Evohaler® 100 µg/inhalation pMDI|Four doses will be administered via Volumatic spacer
16395807|NCT05084209|Behavioral|Parkinson's medical decision making support|Participants will be asked to view and work through medical decision making support resources. The resources will include information on medical decisions that may occur in Parkinson's disease, and general medical decisions that anyone may need to make (i.e. choosing a medical decision maker). The resources will also include suggestions on how to discuss these decisions.
16395808|NCT05084196|Drug|Melatonin|Melatonin 5 mg capsule by mouth at bedtime
16395809|NCT05084196|Other|Placebo Capsule|Placebo capsule by mouth at bedtime
16395810|NCT05084183|Device|PermeaDerm®|Wound Management Device
16395811|NCT05084183|Device|Mepilex Ag|Wound Dressing
16395812|NCT05084170|Procedure|Bilateral anterior cingulotomy|Stereotactic bilateral anterior cingulotomy is a brain operation with demonstrated efficacy in the treatment of intractable pain from a variety of causes, including a few cases of spinal cord injury related neuropathic pain.
16395817|NCT05084092|Device|Intraoperative Radiotherapy (IORT)|Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy. If it is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.
16395818|NCT05084079|Drug|CSII with formula-based initial insulin regimen|Initial total daily insulin dose(TDD) for CSII was calculated with a formula :（estimate TDD-1(eTDD-1) = 0.35× body weight (kg) + 2.05× FPG (mmol/L) + 4.24×triglyceride(mmol/L) + 0.55× waist circumference (cm) - 49.1）, 42% of which was assigned as total basal dose and 58% as total premeal dose, with the pre-meal doses divided into 30:35:35 for breakfast, lunch and dinner.
16395819|NCT05084079|Drug|CSII with weight-based initial insulin regimen|TDD for CSII was started with 0.5 IU/kg, 50% of which was assigned as total basal dose and 50% as total premeal dose, and the total pre-meal dose was divided equally before each meal.
16395820|NCT05084066|Other|Repeated remote ischemic preconditioning|"An automated device performs four 5-minute episodes of upper limb ischemia in which the cuff pressure in the experimental group remains at 200 mmHg for 5 minutes, causing and ensuring ischemia. Ischemic episodes alternate with 5-minute reperfusion. The intervention lasts a total of 35 minutes. The participant places the device on his upper arm and presses the Start button, starting the intervention. The intervention takes place at rest in the patient's home environment daily for 28 days. During the first visit to the research center, the research assistant teaches the participant how to use the device. The device measures the patient's blood pressure at the start of the intervention. If the patient's blood pressure is above 200 mmHg, the device will not perform the intervention."
16395821|NCT05084066|Other|Simulation of repeated remote ischemic preconditioning (sham)|The automated device simulates the intervention of the experimental group with the difference that the device does not apply pressure to the upper limb and, therefore, no ischemia occurs.
16395822|NCT05084053|Drug|TAK-771|Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
16395823|NCT05084040|Other|90 days interval between catheter maintenance|Length of time between catheter maintenances extended from 60 days to 90 days
16395825|NCT05084014|Other|Deep Stripping|The deep longitudinal stripping can be applied on adhesions and knots in muscles. The lengthening stokes are parallel to muscle fiber and applied in an oblique direction with the help of the thumbs of hands/ elbow/ knuckles
16395826|NCT05084014|Other|Kneading|kneading lifts the muscle in circular movements with the help of the hands. It lifted, rolled, and squeezed muscle
16395827|NCT05084001|Drug|silver diamine fluoride|topical application of the agent on tooth surface
16395828|NCT05084001|Drug|sodium fluoride varnish|topical application of the agent on tooth surface
16395829|NCT05084001|Other|tonic water|topical application of tonic water on tooth surface
16395832|NCT05083975|Device|Buzzy System|Vibrating Device
16395833|NCT05083975|Drug|Topical anesthetic|20% benzocaine gel (Gama Dent Topical Gel)
16395834|NCT05083975|Drug|Mepecaine - L 1.8 ml carpule|Local dental anesthetic agent
16395835|NCT05083962|Behavioral|Healthy Lifestyle Program|An intensive behavior change curriculum designed to help create and sustain healthy habits
16395836|NCT05083949|Drug|empagliflozin/metformin|empagliflozin/metformin
16395837|NCT05083949|Drug|Jardiance®|Jardiance®
16395838|NCT05083949|Drug|Glifage®|Glifage®
16395839|NCT05083936|Drug|[18F]FET|Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor
16395840|NCT05083923|Drug|Diroximel fumarate|Administered as specified in the treatment arm
16395886|NCT05083468|Drug|SR750 tablet|The volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water.
16395887|NCT05083468|Drug|matching placebo|The volunteers will be orally administrated by single or multiple dose of matching placebo with 240 mL water.
16395888|NCT05083455|Drug|Rivaroxaban|Any rivaroxaban dispensing claim is used as the exposure group
16395841|NCT05083910|Drug|I.V Oxytocin administration|Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
16395842|NCT05083897|Other|hip adduction isometric contraction|addition of isometric hip adduction contraction to the knee extension for measuring knee extension peak torque by the isokinetic dynamometer
16395843|NCT05083884|Other|No Intervention|This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
16395844|NCT05083871|Other|European Trauma Course|"Structured learning program specifically focused on Trauma management. The course provides frontal lessons, workshops for the technical skills and simulated scenarios.
~Please see https://www.erc.edu/courses/european-trauma-course for additional details"
16395845|NCT05083858|Other|Classical Physiotherapy Program + Cervical Stabilization Exercises|First of all, patients will be taught correct craniocervical flexion movement without activation of superficial muscles in different positions (supine, prone, crawling, sitting, standing). The program will be continued by asking to maintain the cranio-cervical flexion position during all movements. In order to gain dynamic stabilization, unilateral, bilateral, contralateral, ipsilateral and reciprocal extremity movements will be added to the program together with craniocervical flexion movement. Resistance will be added to the exercises as control of the movement is achieved. The exercises will progress from static to dynamic, from stationary floors to moving floors, from simple movements to complex movements.
16395846|NCT05083858|Other|Classical Physiotherapy Program + Oculomotor Exercises|Oculomotor Exercises is a program consisting of exercises that support proprioception in the cervical region. It consists of 4 main contents; Sacadic Eye movements, Gaze stability, Head/eye coordination, Head repositioning exercise.
16395847|NCT05083858|Other|Classical Physiotherapy Program|"Conventional TENS will be applied to apply analgesic current. TENS application will be made to the cervical paravertebral region, using four 5 x 5 cm adhesive surface electrodes, at 80 Hz frequency for 20 minutes, 100 msec.
~All participants will be asked to lie in a prone position. The neck will be in a neutral position. The hot pack will be applied to the cervical region for 20 minutes.
~Classical massage will be applied for 20 minutes using the Swedish technique. The technique will be performed on the upper and neck region of the back with 3 strokes, 3 kneading and 3 strokes. The patient will be massaged while lying in the prone position.
~Stretching/Posture Exercises Exercises will be applied as a 5-10 minute warm-up-cool-down program at the beginning and end of the study. Cervical flexor, lateral flexor, rotator muscles, pectorals, inferior shoulder joint capsule will be stretched. In addition to this, posture exercises will also be done."
16395848|NCT05083845|Procedure|Same blocks with different local anesthetic volume|Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.
16395850|NCT05083806|Device|Multispectral Optoacoustic Tomography|Non-invasive optoacoustic imaging of muscular structure
16395851|NCT05083793|Drug|Pregabalin 150mg|The effect of pregabalin on post-operative pain
16395852|NCT05083793|Other|Placebo|patients will receive placebo one hour before operation
16395854|NCT05083767|Other|Experimental|The study protocol of WBV includes twelve weeks of whole-body vibration training provided to the Type 2 diabetic patients. It was recommended to all participants that they follow their regular diet and medication during the training. Two sets of six 1-minute vibration squats were designed with 20 seconds of rest, 3 times weekly for a duration 12 weeks (total workout time 36 minutes a week), using a vertical vibration machine. The six static positions consisted of (a) a deep squat position (knee angle 900) (b) an elevated squat position (knee angle 1250) (c) an elevated squat position (with elevated heels) (d) a slight knee flexion1 (hand straps with shoulder bending) (e) a slight knee flexion (hand straps with shoulder abduction) and (f) a slight knee flexion 3 (hand straps with elbow flexion). The training load steadily increased from the initial vibration of 30 Hz and the platform amplitude was raised from 2 mm at week 1 to 40 Hz and from 4 mm at week 5 to the completion of training.
16395855|NCT05083767|Other|Control|The control group was advised to their normal physical activity level, diet, and medication.
16395856|NCT05083754|Drug|Retifanlimab|Anti-PD-1 Therapy
16395857|NCT05083754|Drug|Temozolomide|Anti-PD-1 Therapy
16395858|NCT05083754|Radiation|Radiation Therapy|Standard of Care
16395859|NCT05083741|Device|Chitogel|post-operative dressing within standard of care
16395860|NCT05083741|Device|Nexfoam|post-operative dressing within standard of care
16395861|NCT05083728|Diagnostic Test|CT|Clinicians are free to choose the adult subjects in whom a non-contrast calibrated CT-scan will be performed as a part of routine clinical care. The decision to order a noncontrast CT-scan of the shoulder must be made prior to, and independently from, the decision to enroll the patient.
16395862|NCT05083702|Procedure|Fluoroscopy-guided superior hypogastric plexus block transdiscal approach|Patient lies prone, L5-S1 interspace identified under fluoroscopy, the skin is prepared and sterile drapes are placed after local anesthetic infiltration of the skin the subcutaneous tissue with 2% lidocaine a 20 guage, 15 cm needle with short bevel is inserted at the center of L5- S1 interlaminar space under anteroposterior fluoroscopic vision. The needle is then advanced toward the intervertebral disc. After confirmation, the needle is advanced through the intervertebral disc until it exists at its anterior surface confirmed by administration of 4 ml of soluble contrast media in both lateral and anteroposterior fluoroscopic view. Neurolysis is performed with 8 ml 8 % phenol solution. After neurolysis, 0.5 ml of saline is given to avoid the deposition of phenol within the intervertebral disc material. While withdrawing, the needle cephazoline 50 mg in 1 ml is injected into the disc.
16395889|NCT05083455|Drug|Enoxaparin|Any enoxaparin dispensing claim is used as the reference group
16395863|NCT05083702|Procedure|ultrasound-guided superior hypogastric plexus block|Patients are placed in the supine position and after sterilization, the low-frequency curved probe is used in the longitudinal axis to visualize the aortic bifurcation and is identified using a longitudinal Ultra-Sound (Phillips Healthcare, Andover, Massachusetts, US). Next, the probe is placed deeply transverse till aorta end and bifurcation seen of iliac vessels once seen we enter out of plane and inject.as it lies in front the vertebral body of the L5 vertebra. Local infiltration with 1% lidocaine is obtained at port of entry 1-1.5 inches below the umbilicus. A 15-cm, 22-G Chiba needle is inserted (out-of-plane) and advanced by avoiding vascular structures until contact with the L5-body. The needle will be withdrawan the 1-2 mm and inject 8 ml 8% phenol in saline. Finally, 0.5 ml of lidocaine is injected during Chiba needle removal
16395864|NCT05083689|Drug|Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide|31 cases in intervention group receive injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day
16395865|NCT05083689|Drug|Injections of 1.25 mg of intravitreal bevacizumab with artificial tears|31 cases in control group receive intravitreal injection of 1.25 mg bevacizumab monthly for 3 months (months 0, 1 and 2) plus artificial tears (twice a day as a placebo)
16395866|NCT05083676|Behavioral|Acceset Intervention|". The intervention comprises of: i) Digital peer support training for youth befrienders to equip them with the knowledge and application of the four active ingredients-Mattering, selfhood, compassion, and mindfulness-to provide effective peer support as they respond to youth seekers' emotional experiences.
~ii) Acceset Intervention with features or digital markers of psychological well-being, peer emotional disclosure process and community engagement."
16395868|NCT05083650|Procedure|Macular hole closure with amniotic membrane with/without internal limiting membrane peeling|Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade
16395869|NCT05083637|Drug|L- carnitine oral solution|The L-carnitine syrup formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up
16395870|NCT05083637|Other|Placebo|The placebo formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up
16395871|NCT05083624|Behavioral|rehabilation therapy|After comprehensive assessment by doctors, nurses and rehabilitation therapists, patients gradually begin rehabilitation treatment.IMS 0: no mobilisation or passively exercised by staff. IMS 1: sitting in bed and actively exercising .IMS 2: passively moved to chair without standing.IMS 3: sitting over edge of bed.IMS 4: standing in front of bed.IMS 5: transferring bed to chair.IMS 6: marching on spot.IMS 7: walking with assistance of more than one person.IMS 8: walking with assistance of one person.IMS 9: walking independently with a gait aid.IMS 10: walking independently without a gait aid.
16395872|NCT05083611|Other|GraMI|The intervention will last 6 weeks. Each technique lasts for 2 weeks. The first two techniques will be performed through the previously designed mobile application and the last technique will be performed through a mirror box. The patient can do it autonomously with the supervision of the principal investigator.
16395876|NCT05083572|Drug|Colonic lavage with polyethylene glycol|The subjects will orally consume a split dose of bowel preparation (PEG); 2 litres in the evening (Day -1) and another 2 litres the following morning (Day 1).
16395877|NCT05083572|Dietary Supplement|Probiotic|The subjects will self-administer orally two capsules of VSL#3 with room temperature water (as heat may inactivate the live bacteria, rendering it less effective) twice daily for 28 days.
16395878|NCT05083572|Drug|Antibiotic|"The subjects will undergo pre-treatment to cleanse the gut by consuming orally one tablet of antibiotic rifaximin (200mg) daily for 14 days prior to the initiation of VSL#3 course."
16395881|NCT05083546|Drug|Gly-low|MGO cocktail containing a combination of alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine
16395882|NCT05083546|Other|Placebo|sugar pill
16395883|NCT05083533|Behavioral|tele-rehabilitation exercise|"Telerehabilitation allows patients to interact with providers remotely and can be used both to assess patients and to deliver therapy. Treatment program planned to stretch the muscles of individuals with short hamstring muscle group.
~Stretching exercises for hamstring muscle group shortening were applied 4 days a week, which lasted for 8 weeks in total. For the first four weeks, 3 different stretching exercises per day were planned and performed as 10 seconds of stretching and 5 repetitions. For the last four weeks, 4 different stretching exercises were planned per day and performed with 20 seconds of stretching and 10 repetitions."
16395884|NCT05083533|Behavioral|Home exercise|All participants received home exercise for 8 weeks. The exercise program includes stretching exercises Stretching exercises for hamstring muscle group shortening were applied 4 days a week, which lasted for 8 weeks in total. For the first four weeks, 3 different stretching exercises per day were planned and performed as 10 seconds of stretching and 5 repetitions. For the last four weeks, 4 different stretching exercises were planned per day and performed with 20 seconds of stretching and 10 repetitions.
16395885|NCT05083481|Drug|ASP1570|Oral tablet
16395892|NCT05083429|Drug|Salmeterol|Salmeterol inhaler dispensing claim is used as the reference
16395893|NCT05083429|Drug|Tiotropium|Tiotropium dispensing claim is used as the reference
16395896|NCT05083403|Device|AcumenTM HPI Software Feature|The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
16395897|NCT05083403|Other|Non-protocolized Standard of Care|Non-protocolized standard of care to treat subjects
16395899|NCT05083364|Drug|ARO-C3|ARO-C3 for sc injection
16395900|NCT05083364|Drug|Placebo|sterile normal saline (0.9% NaCl) for sc injection
16395901|NCT05083338|Procedure|Biospecimen Collection|Undergo blood sample collection
16395902|NCT05083338|Procedure|Pain Assessment|Undergo pain assessment
16395903|NCT05083338|Other|Questionnaire Administration|Complete questionnaires
16395908|NCT05083299|Drug|Sarpogrelate|Anpl-one SR
16395910|NCT05083273|Other|Cohorte|Completion of a socio-demographic, professional, medical and personal questionnaire
16395911|NCT05083260|Drug|NE3107|NE3107 is an investigational orally bioavailable, blood-brain barrier permeable anti-inflammatory agent with a new mechanism of action targeting multiple mechanisms of pathology in Parkinson's disease
16395912|NCT05083260|Drug|placebo|Hard gelatin capsule containing only common excipients for oral formulations
16395913|NCT05083247|Drug|mFOLFIRINOX or gemcitabine-nabpaclitaxel|mFOLFIRINOX or gemcitabine-nabpaclitaxel +isotoxic high-dose SBRT: 5 x 7Gy with Simultaneous Integrated Boost (SIB) up to maximum 55Gy
16395914|NCT05083234|Other|Moisturizing with SSO|Vital signs of newborns in the sunflower seed oil group were measured. The skin of newborns in the sunflower seed oil group was wiped without rubbing. The skin of newborns in the sunflower seed oil group was evaluated with the NSCS scale.
16395915|NCT05083234|Other|Moisturizing with LV|Vital signs of newborns in the liquid vaseline group were measured. The skin of newborns in the liquid vaseline group was wiped without rubbing. The skin of newborns in the liquid vaseline group was evaluated with the NSCS scale.
16395916|NCT05083234|Other|The control group was not moisturized.|Vital signs of newborns in the control group were measured. The skin of newborns in the control group was wiped without rubbing. The skin of newborns in the control group was evaluated with the NSCS scale.
16395917|NCT05083221|Behavioral|Hear-Talk-Activity audiological program|The participants were randomly assigned to either the experimental group or the waiting-list control group, using a computer-generated list of random numbers.
16395918|NCT05083208|Drug|Parsaclisib|"Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional 3+3 model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study.
~Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks (including the treatment received in Phase Ib).
~Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years."
16395919|NCT05083208|Drug|Chidamide|"Phase Ib: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.
~Phase II: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast until disease progression, death or unacceptable toxicity developments."
16395920|NCT05083195|Other|Home-based Telerehabilitation|Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
16395921|NCT05083195|Other|Exercise Brochure|Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.
16395922|NCT05083182|Drug|Ustekinumab|Ustekinumab will be administered as subcutaneous injection.
16395923|NCT05083169|Drug|Daratumumab|Daratumumab will be administered SC injection.
16395924|NCT05083169|Drug|Pomalidomide|Pomalidomide will be administered orally.
16395925|NCT05083169|Drug|Dexamethasone|Dexamethasone will be administered orally or IV.
16395926|NCT05083169|Drug|Bortezomib|Bortezomib will be administered SC injection.
16395927|NCT05083169|Drug|Teclistamab|Teclistamab will be administered SC injection.
16395957|NCT05082909|Drug|Probenecid|Addition of 500mg QDS to oral penicillin.
16395958|NCT05082896|Procedure|Type of anesthesia choice|Use of conscious sedation vs. general anesthesia
16395929|NCT05083130|Behavioral|a wake prone positioning|The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position for at least 8 hours per day. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers.
16395930|NCT05083117|Drug|XW001|It is anticipated that inhalation of 1 mg XW001 solution up to 14 days will result in a relatively lower systemic exposure in COVID-19 patients on oxygen therapy compared to that in healthy participants as COVID-19 patients tend to have impaired lung function of diffusive, restrictive, obstructive, or mixed origins.
16395931|NCT05083117|Drug|Placebo|It is anticipated that inhalation of 1 mg Placebo solution up to 14 days will result in a relatively lower systemic exposure in COVID-19 patients on oxygen therapy compared to that in healthy participants as COVID-19 patients tend to have impaired lung function of diffusive, restrictive, obstructive, or mixed origins.
16395932|NCT05083104|Diagnostic Test|laboratory investigations on coagulation profiles|CBC ,PT ,aPTT ,Protein C .Protein S ,ATIII and vWF
16395933|NCT05083091|Behavioral|Mindfulness and Attention Training|Guided mindfulness meditation with attention monitoring and acceptance skills training
16395934|NCT05083091|Behavioral|Mindfulness training|Guided mindfulness meditation, no attention monitoring or acceptance skills training
16395935|NCT05083091|Behavioral|Coping Condition|Guided training focused on coping effectiveness strategies, no monitoring or acceptance instruction
16395939|NCT05083052|Other|Propolis 15%|oothpaste formulation with 15% propolis.
16395940|NCT05083052|Other|Propolis 10%|Toothpaste formulation with 10% propolis.
16395941|NCT05083052|Other|Placebo|Formulation of toothpaste without active ingredient.
16395942|NCT05083026|Diagnostic Test|COVID-19 neutralizing antibody|"This study enrolled persons already who received COVID-19 vaccination under government policy.
~We collect 5mL blood at 2, 4, 6, 9, 12 months after COVID-19 vaccination
~isolate serum and store in -80 degree deep freezer
~measure neutralizing Antibody"
16395943|NCT05083013|Diagnostic Test|Reverse transcription polymerase chain reaction (RT-PCR)|For SARS Corona Virus 2 (COV2) confirmation
16395944|NCT05083013|Diagnostic Test|Glycated haemoglobin (HbA1C)|Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control
16395945|NCT05083013|Radiation|High Resolution Computed Tomography (HRCT)|with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation
16395946|NCT05083013|Diagnostic Test|Routine Laboratory investigations|"Arterial blood gases (ABGs)
~Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)"
16395947|NCT05083013|Diagnostic Test|Random Blood Sugar (RBS)|Blood Sugar will be measured before each meal and before bed time during hospitalization.
16395948|NCT05083000|Drug|Topotecan|Topotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitor activity. It is a well-established chemotherapeutic agent used for cancer treatment.
16395949|NCT05082974|Drug|OC-01 (varenicline 0.6mg/ml) nasal spray|OC-01 (varenicline 0.6mg/ml) nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of Drye Eye Disease. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production to bathe the corneal nerve endings in a protective layer of tear film. In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway.
16395950|NCT05082974|Drug|Placebo (vehicle) nasal spray|Placebo (vehicle) nasal spray [control]
16395951|NCT05082961|Other|Collection of blood samples|Samples to evaluate the circulating CD8+ T cell count.
16395956|NCT05082922|Behavioral|Hybrid treatment|Transdiagnostic emotion-focused treatment provided by a psychologist with, when needed, support of a medical doctor (ensuring adherence to medical guidelines) and a physiotherapist (providing assessment and treatment support in exposure for physical activities). Depending on the length of the waiting period (randomly assigned to be either 4, 5 or 6 weeks), the treatment period varies between 14-16 weeks and contains 10-15 sessions.
16395959|NCT05082883|Diagnostic Test|Risk Assessment Cognitive Screening|Completion of a risk assessment cognitive screening app that includes working memory and voice-based tasks
16395960|NCT05082870|Behavioral|Supportive-expressive group therapy (SEGT)|The SEGT approach fosters mutual support, promotes openness and emotional expression. SEGT will be delivered and co-facilitated by a psychiatrist and an allied healthcare professional. It is a 6-module program held over a 3-week period (approximately 2 hour sessions X 2 week) that is framed within social cognitive theory, whereby resilience to adversity (limb loss in this instance) relies on personal enablement.
16395963|NCT05082844|Radiation|MRI assessment|Evaluation of the clinical-radiological results from the case series of patients surgically treated for cuff rotator lesions from 2009 to 2020 at the Shoulder-Elbow Department . At 12 months the result is considered stabilized, so we will proceed to collect all case histories that have passed this follow-up period.
16395964|NCT05082831|Biological|microfracture surgery + HST003|This is an Intervention Model where all patients who are identified/confirmed candidates for microfracture surgery will be enrolled to receive the microfracture surgery (standard of care). Ten (10) patients will be randomized to receive the study intervention (HST003). HST003 will be injected into the microfracture defects (interstices) and fill the remainder of the defect to the cartilage margin following surgery. The primary purpose of the study is to compare the two groups: microfracture surgery + HST003 as compared to the microfracture surgery only group.
16395965|NCT05082818|Combination Product|Chemotherapy, Radiotherapy and surgery|Trans urethral resection of the tumour or radical cystectomy
16395966|NCT05082792|Diagnostic Test|doppler ultrasound|"Doppler ultrasound evaluation of AVF:
~pre-operative evaluation: venous system (patency of central veins and deep venous system, patency of superficial veins, the latter diameter, depth form skin surface, distance from nearby artery, any sizable adjacent tributaries), and arterial system including morphological evaluation (course, diameter, wall alterations, any stenoocclusive disorders) and functional evaluation (flow volume and ability to dilate)
~post-operative evaluation: anastomotic site (type of anastomosis, patency, diameter, PSV and any other morphologic alterations), inflow afferent artery (diameter, PSV and flow volume), outflow efferent vein (patency, diameter, color flow, spectral waveform)
~the first post-operative sonographic evaluation will be done after removal of stiches from the wound and periodic monitoring every one week up until completion of 6 weeks"
16395969|NCT05082753|Drug|Ivermectin tablets (3 mg Ivermectin)|Two Ivermectin tablets were administered orally.
16395970|NCT05082753|Drug|Stromectol ® tablets|Two Ivermectin tablets were administered orally.
16395971|NCT05082740|Other|Notification of a revised breast cancer risk estimate|These women will be given the opportunity to learn of their revised breast cancer risk estimate which has been re-calculated with the inclusion of new strong independent risk factors. These women will be offered a clinical consultation to discuss their risk and will a subset will be asked to take part in a qualitative interview about their experiences.
16395972|NCT05082727|Dietary Supplement|KOVIR (TD0068) oral capsule|KOVIR (TD0068) is a soft capsule containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed medicinal herbs 43.6mg
16395973|NCT05082727|Dietary Supplement|Placebo oral capsule|Placebo
16395974|NCT05082714|Drug|Tocilizumab|tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)
16395975|NCT05082714|Drug|Baricitinib|The baricitinib intervention consists of baricitinib at a dose of 4 mg/day (given daily for up to 14 days or until discharge from hospital, whichever occurred first); however, 2 mg/day will be given if the patient has a baseline eGFR of 30 to less than 60 mL/min/1·73 m2
16395976|NCT05082688|Biological|Herpes zoster vaccination (Shingrix, GSK)|Shingrix is an ASO1-adjuvanted herpes zoster vaccination used to prevent shingles and its associated complications in at-risk populations
16395977|NCT05082688|Biological|Influenza Vaccine (Fluarix Tetra Northern Hemisphere 2021, GSK)|Fluarix Tetra is a quadrivalent inactivated influenza vaccine
16395978|NCT05082688|Biological|Placebo|0.9% NaCl
16395979|NCT05082675|Procedure|HLA Matched allogeneic transplant|
16395980|NCT05082662|Drug|Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium)|One Diclofenac tablet was administered orally.
16395981|NCT05082662|Drug|Cataflam® 50 coated tablet|One Diclofenac tablet was administered orally.
16395984|NCT05082623|Other|Music|Music medicine
16395985|NCT05082623|Other|Earplug|Earplug with noise cancelling
16395986|NCT05082610|Drug|HMBD-002|IgG4 monoclonal antibody (mAb) targeting the V-domain immunoglobulin suppressor of T cell activation (VISTA) receptor.
16395987|NCT05082610|Drug|Pembrolizumab|IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and programmed cell death ligand 2 (PD-L2).
16396098|NCT05042141|Dietary Supplement|KOVIR oral capsule|KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
16396099|NCT05042141|Dietary Supplement|Placebo oral capsule|Placebo
16395989|NCT05082584|Drug|Vadadustat|Vadadustat tablet orally once a day for 52 weeks
16395990|NCT05082571|Drug|vadadustat|Vadadustat tablet orally once a day for 52 weeks
16395991|NCT05082558|Other|No intervention, as this was retrospective study.|No intervention performed. Participants were entolled retrospectively and medical records were accessed for data.
16395993|NCT05082532|Other|Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .|we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions.
16395994|NCT05082519|Behavioral|IDEAL2 Intervention|Intervention of diet and exercise to improve outcomes for ALL patients
16395995|NCT05082506|Behavioral|Acupressure|Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief.
16395996|NCT05082493|Drug|Berubicin Hydrochloride|Berubicin will be administered as 1-hour infusions each day for 3 consecutive days followed by 18 days off drug (ie, 21-day cycles). The starting dose is based on population PK modeling of data from adult studies and will be 1.20 mg/m2 (Dose Level 1). During the study, PK data will be incorporated into a PK model on an ongoing basis and may be used to inform dose escalation decisions
16395999|NCT05082454|Device|Open repair|Open repair of the aortic heart valve and ascending thoracic aorta
16396000|NCT05082441|Drug|Liposomal bupivacaine|Exparel mixed with bupivacaine to be infiltrated in the subcutaneous region of the wound instead of plain bupivacaine
16396001|NCT05082441|Drug|Bupivacaine Hydrochloride|plain bupivacaine subcutaneous injection as standard of care control
16396003|NCT05082402|Diagnostic Test|Swept Source Optical Coherence Tomography Angiography|The PLEX Elite 9000 is an FDA cleared research device for use in ocular imaging obtained by Northwestern University by way of a purchase agreement with the manufacturer, Carl Zeiss Meditec, Inc. It is currently unavailable outside of participation in the ARI Network, a cloudbased storage and image processing platform using deidentified information shared between academic institutions. The ARI Network is managed by a group of physicians and scientists from around the world that are working to better understand eye diseases.
16396004|NCT05082376|Drug|ChapStick Lip Moisturizer Original|Sunscreen lip balm.
16396005|NCT05082207|Other|Remote Ischemic Preconditioning|Three cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure of systolic blood pressure plus 50 mm Hg.
16396006|NCT05082207|Other|sham group|a deflated cuff placed on the upper arm for 30 min
16396007|NCT05082077|Device|LIVERguard|The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.
16396009|NCT05081479|Drug|N-Acetylcysteine|N-AC infusion will begin the day before CAR T cell infusion and continuously infused over 24-hours for 14 days or until time of discharge whichever is earlier. Interruptions of N-AC infusion for medical reasons are permissible. The dose for patients <45kg will be adjusted to weight based dosing.
16396010|NCT05081362|Other|Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity|Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position
16396011|NCT05080738|Other|Upper Extremity Home Exercises|"The exercises will be performed as follows:
~Stretching exercises: It will be applied in the form of 10 seconds*10 repetitions for fingers, wrists, elbows and shoulders.
~Strengthening exercises: It will be applied as 2 sets*10 repetitions for fingers, wrists, elbows and shoulders."
16396012|NCT05079724|Procedure|Cardiac Surgery|About 3.5-31.0% of Patients undergoing cardiac surgery Complains from Postoperative Acute renal injury (AKI) that is a severe complication increasing the risk factor for mortality about 8-folds, The occurrence of AKI in patients undergoing cardiac surgery raises the mortality rate from 0.4-4.4% to 1.3-22.3%; when those same patients require dialysis.
16396014|NCT05078684|Procedure|Left ganglion stellate block|Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
16396015|NCT05078684|Procedure|Sham left ganglion stellate block|Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
16396016|NCT05075941|Other|Vaccination coverage|proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
16396017|NCT05075551|Device|Acupuncture|Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL23 is in the sacral region, in the second posterior sacral foramen; BL54 is in the fourth posterior sacral foramen, 3 cun beside the median sacral crest; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
16396018|NCT05075551|Device|Sham acupuncture|Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used.These volunteers will receive relatively shallow needling at bilateral sham SP6, BL54, BL23 and BL35. This treatment gets involved in the same duration and frequency of sessions, but the treatment was delivered superficially at non-acupuncture points 10 mm to the lateral of corresponding acupuncture and not above a meridian line (10mm to SP6, BL54, BL23 and BL35).The same equipment of fMRI scanner will be used.
16396019|NCT05075551|Other|fMRI scan|Both two group will get fMRI scan week 0 (before treatment), week 12 (after treatment) and week 36 (following up). The resting-state fMRI data will be obtained by using a 3.0T GE MR 750 MRI scanner with an eight-channel phase array head coil at the Huashan Hospital, Shanghai. The high resolution T1-weighted magnetic resonance images will be collected by a three-dimensional fast spoiled gradient-echo dual-echo sequence [repetition time (TR) = 8100 ms; echo time (TE) = 3.1 ms; FA = 8 deg; matrix=256 × 256; field of view (FOV)=25.6× 25.6 cm2; slice thickness=1 mm; no gap and 156 slices]. The whole resting state fMRI data will be acquired by using a gradient-recalled echo-planar imaging pulse sequence (TR/TE = 2,000/30 ms; FA = 90°; acquisition matrix = 64×64; FOV = 22×22 cm2; slice thickness= 4 mm; 43 slices and total 240 time points; no gap).
16396020|NCT05074277|Behavioral|Simulated short term night shift work schedule|Participant sleep schedules (in the experimental arm) will be modified to simulate short-term (3 consecutive nights) night shift work schedule (kept awake at night and offered sleep opportunities during the day instead) in each of two inpatient stays.
16396021|NCT05074251|Diagnostic Test|HIV self test|For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use & importance of partner testing, to take home to their partner(s).
16396022|NCT05074251|Behavioral|Counseling and referral for partner testing|Counseling and refer participant's partner for facility based HIV testing
16396023|NCT05074121|Drug|N-acetylcysteine|N-acetylcysteine
16396024|NCT05074121|Other|Placebo|Placebo
16396025|NCT05074069|Procedure|Gynaecological reconstruction|Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation
16396026|NCT05073822|Drug|Tacrolimus|reduction of both standard Tacrolimus & Mycophenolate mofetil does in one arm
16396027|NCT05073705|Behavioral|Self-management intervention|Intervention condition. The intervention to be tested will emerge from Aim 2 -- a self-management intervention for ALHIV to facilitate their transition to adult HIV care
16396028|NCT05073653|Diagnostic Test|68Ga-PSMA PET/CT|Exploratory, Single-institution Study, Comparing 68Ga-GRP PET/CT Versus 68Ga-PSMA PET/CT in Patients Diagnosed With Prostate Cancer of Low and Intermediate Risk for Radical Prostatectomy
16396029|NCT05073653|Diagnostic Test|68Ga-GRP PET/CT|Exploratory, Single-institution Study, Comparing 68Ga-GRP PET/CT Versus 68Ga-PSMA PET/CT in Patients Diagnosed With Prostate Cancer of Low and Intermediate Risk for Radical Prostatectomy
16396030|NCT05073328|Other|COVID-19 required hospitalisation|Patients who contracted a COVID19 required hospitalisation
16396031|NCT05073016|Other|neuromodulation|neuromodulation: Neuromodulation is technology that acts directly upon nerves. It is the alteration-or modulation-of nerve activity by delivering electrical or magnetic stimulus/current.
16396032|NCT05073016|Other|motor learning training|motor learning training requires performing a sequential training called finger taping task
16396033|NCT05072964|Device|FARAPULSE Pulsed Field Ablation System|A pulmonary vein isolation will be performed using catheter ablation
16396034|NCT05072574|Other|Specific dietary treatment and follow-up using coaching techniques|Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
16396035|NCT05072080|Biological|CHIKV VLP/adjuvant|PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%
16396036|NCT05072080|Biological|Placebo|Placebo is comprised of formulation buffer
16396037|NCT05072054|Drug|Atorvastatin Oral Tablet|Atorvastatin 40 mg
16396038|NCT05072054|Drug|Rosuvastatin Oral Tablet|Rosuvastatin 20 mg
16396039|NCT05071807|Drug|Pecans|Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.
16396040|NCT05071807|Other|Usual Care|Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
16396041|NCT05071755|Procedure|Gastrectomy|Radical Total Gastrectomy, Radical Partial gastrectomy (Proximal / Subtotal)
16396042|NCT05070949|Behavioral|Mindful Self-Compassion|Bi-weekly meeting will involve six lessons: What is Self-Compassion , Practicing Self-Compassion, Discovering your Compassionate Voice, Self-Compassion and Resilience , Self-Compassion and Burnout and Making it Count
16396043|NCT05070780|Device|Robot-assisted examination|evaluation of muscle tone with Robot-assisted perturbation
16396046|NCT05069259|Other|Stool sample collection|collection for measuring calprotectin levels
16396047|NCT05064800|Drug|Dabigatran|A single dose of Dabigatran on Day 1
16396048|NCT05064800|Drug|PF-07321332/ritonavir + Dabigatran|PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2
16396049|NCT05064800|Drug|Ritonavir + Dabigatran|Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2
16396052|NCT05062928|Other|Virtual coach|This group will be trained and assessed by the virtual coach.
16396053|NCT05062876|Drug|AD-214|1 tablet administered before the breakfast during 7 days
16396054|NCT05062876|Drug|AD-2141|1 tablet administered before the breakfast during 7 days
16396055|NCT05062616|Procedure|Toenail surgery|modified Winograd procedure
16396162|NCT05020236|Drug|Elranatamab|subcutaneous
16396163|NCT05020236|Drug|Daratumumab|Daratumumab / hyaluronidase, subcutaneous
16396057|NCT05061680|Device|endoscopic short duration papillary large balloon dilation|During the large balloon papillary dilation investigators follow the cholangiogram and stop the dilatation as soon as the disappearance of the waist of the papilla is noticed.
16396058|NCT05061537|Biological|PF-07263689|Genetically engineered oncolytic vaccinia virus
16396059|NCT05061537|Biological|Sasanlimab|A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2
16396060|NCT05060913|Drug|EMLA Cream|Effect of 5% Emla cream on pricking pain measured on VAS scale.
16396061|NCT05060913|Drug|Benzocaine Gel|Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.
16396062|NCT05060029|Drug|Lactobacillus Species|Lactobacilli containing suppositories have been successfully used in the past to maintain the vaginal environment and for treatment of infections like BV. Some of the Lactobacilli species that have been used include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus plantarum, none of which demonstrated any safety concerns. The investigational product, which contains a Lactobacilli complex as its main component, has already been marketed as a tool to maintain vaginal microbial balance, pH and the prevention of microbial infection, thus there are no additional safety concerns or risks involved in this clinical trial design.
16396063|NCT05060029|Other|Placebo|Coconut Oil Fatty Acids
16396064|NCT05059665|Diagnostic Test|Helio Liver Test|De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
16396065|NCT05058196|Radiation|Whole breast radiotherapy|Whole breast radiotherapy after surgery
16396066|NCT05058196|Radiation|Intra Operative Radiotherapy|Intra Operative Radiotherapy
16396067|NCT05057013|Drug|HMBD-001|Intravenous infusion given over a 21 or 28 day cycle dependent on dosing frequency. Number of cycles: 6 or until disease progression or unacceptable toxicity develops.
16396068|NCT05054920|Other|concentric exercises|concentric exercises for rotator cuff. internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients
16396069|NCT05054920|Other|eccentric exercises|Eccentric exercises exercises for rotator cuff internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients
16396070|NCT05054920|Other|Stretching|stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
16396071|NCT05051579|Drug|LY3502970|Administered orally
16396072|NCT05051579|Drug|Placebo|Administered orally
16396075|NCT05050682|Drug|PF-07304814|PF-07304814 is an anti-viral, formulated for intravenous delivery
16396076|NCT05049902|Drug|Amoxicillin|Use according to the drug combination options selected by each center.
16396077|NCT05049902|Drug|Clarithromycin|Use according to the drug combination options selected by each center.
16396078|NCT05049902|Drug|Tetracycline|Use according to the drug combination options selected by each center.
16396079|NCT05049902|Drug|Metronidazole|Use according to the drug combination options selected by each center.
16396080|NCT05049902|Drug|Bismuth Potassium Citrate|Use according to the drug combination options selected by each center.
16396081|NCT05049902|Drug|Colloidal Bismuth Pectin|Use according to the drug combination options selected by each center.
16396082|NCT05049902|Drug|Vonoprazan fumarate|Use according to the drug combination options selected by each center.
16396083|NCT05048719|Drug|LY3502970|Administered orally
16396084|NCT05048719|Drug|Dulaglutide|Administered subcutaneously
16396085|NCT05048719|Drug|Placebo|Administered orally
16396086|NCT05048719|Drug|Placebo|Administered subcutaneously
16396087|NCT05048069|Drug|Mucosta®SR Tablets 150mg(Rebamipide)|adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
16396088|NCT05047900|Diagnostic Test|Rapid antigen testing kit|COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest
16396093|NCT05045144|Biological|RSV MAT Lot 1 vaccine (GSK3888550A)|One dose of RSV MAT Lot 1 vaccine (GSK3888550A), administered intramuscularly in the deltoid region of the left arm, at Day 1.
16396094|NCT05045144|Biological|RSV MAT Lot 2 vaccine (GSK3888550A)|One dose of RSV MAT Lot 2 vaccine (GSK3888550A), administered intramuscularly in the deltoid region of the left arm, at Day 1.
16396095|NCT05045144|Biological|RSV MAT Lot 3 vaccine (GSK3888550A)|One dose of RSV MAT Lot 3 vaccine (GSK3888550A), administered intramuscularly in the deltoid region of the left arm, at Day 1.
16396096|NCT05045144|Biological|Flu D-QIV vaccine|One dose of Flu D-QIV vaccine administered intramuscularly: - in the deltoid region of the right arm, at Day 1 for the RSV1+Flu, RSV2+Flu and RSV3+Flu groups. - in the deltoid region of the left arm, at Day 1 for the Flu+P group. - in the deltoid region of the non-dominant arm, at Day 31 for the RSV1, RSV2 and RSV3 groups, as an optional vaccination for participants to provide standard of care.
16396097|NCT05045144|Drug|Placebo|One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.
16396164|NCT05020236|Drug|Pomalidomide|oral
16396102|NCT05039073|Drug|Brentuximab Vedotin|Given IV
16396103|NCT05039073|Procedure|Hematopoietic Cell Transplantation|Undergo HSCT
16396104|NCT05039073|Biological|Nivolumab|Given IV
16396105|NCT05039073|Other|Quality-of-Life Assessment|Ancillary studies
16396106|NCT05039073|Other|Questionnaire Administration|Ancillary studies
16396107|NCT05036967|Drug|HF medication|Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
16396108|NCT05036577|Drug|Orelabrutinib|"Orelabrutinib will be given as 150 mg/d or 200 mg/d orally 72h after MTX infusion or MTX clearance, every 21 days for 6 cycles during combination induction treatment.
~Daily Orelabrutinb with dose in last cycle of induction will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first)."
16396109|NCT05036577|Drug|Rituximab|Rituximab 375 mg/m2 intravenous infusion d1, every 21 days for 6 cycles during combination induction treatment.
16396110|NCT05036577|Drug|Methotrexate (MTX)|high-dose Methotrexate 3.5 g/m2 intravenous infusion (3h) d2, every 21 days for 6 cycels during combination induction treatment.
16396111|NCT05036577|Drug|Dexamethasone|Dexamethasone 10-15 mg, iv, d2-4, every 21 days for 6 cycles during combination induction treatment.
16396126|NCT05033626|Procedure|Simultaneous thyroidectomy and hyoid suspension|Under endotracheal anesthesia, a horizontal skin incision up to 50 mm long is made at the level of the upper thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated and transected. Using microsurgical techniques, neurolysis of the recurrent laryngeal nerves is performed. The quality control of the return of the laryngeal nerves is ensured to the required extent using the neuromonitoring apparatus.
16396127|NCT05033626|Procedure|Thyroidectomy|The hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery.
16396128|NCT05032950|Drug|Midazolam|Midazolam administered as a single dose on Day 1
16396129|NCT05032950|Drug|PF-07321332/ritonavir + Midazolam|"PF-07321332/ritonavir:
~Administered orally every 12 hours for a total of 9 doses on Days 1-5
~Midazolam:
~Administered orally as a single dose on Day 5"
16396130|NCT05032950|Drug|Ritonavir + Midazolam|"Ritonavir:
~Administered orally every 12 hours for a total of 9 doses on Day1-5.
~Midazolam:
~Administered orally as a single dose on Day 5"
16396131|NCT05032560|Drug|ABX464|Drug: ABX464 ABX464 is a new anti-inflammatory drug
16396132|NCT05032560|Drug|Placebo|Drug: Matching Placebo placebo matching with ABX464
16396133|NCT05031429|Other|Time Limited Eating|Includes an 8-hour feed/16-hour fast for 7 days per week, with consumption of all of calories from 11 AM to 7 PM. Can consume non-caloric beverages (water, tea, coffee) during the fasting period. No caloric restriction will be used.
16396134|NCT05030519|Drug|Pyrotinib|Pyrotinib 400 mg once daily(monotherapy or combined chemotherapy)
16396135|NCT05029687|Behavioral|Youth-Led Hypertension Education Digital Badge|The intervention is a youth-led HTN education digital badge, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.
16396165|NCT05020236|Drug|Dexamethasone|oral
16396136|NCT05029687|Behavioral|Job Readiness/Non-Hypertension Digital Badge(s)|"For dyads that are randomized into the control arm, the youth will complete job readiness digital badges. These will include existing LRNG Career & Job Readiness digital badge playlists, with such playlists as, Interview Preparation, Resume Ready, and Professionalism. While this group may complete multiple digital badges, the total time needed to complete the badges will be approximately equivalent to that of the intervention group (eg. one hour per week for each arm)."
16396150|NCT05027815|Biological|Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells|cryopreserved cellular therapy product in cryostor CS5, for IV infusion
16396151|NCT05027503|Other|Exercise with hippotherapy simulator|30-minute (5 min warm-up+20 min exercise+5 min cool-down) center-based exercise with the hippotherapy simulator will be done 2 days a week for 8 weeks.
16396152|NCT05027503|Other|Respiratory Physiotherapy|Respiratory physiotherapy includes breathing control (5x2), diaphragmatic breathing exercises (5x2), thoracic expansion exercises (5x2), incentive spirometer (5x2), opep device (5x2), postural drainage and percussion and cough improvement techniques (10 min). Home-based respiratory physiotherapy will be applied twice a day and every day of the week for 8 weeks.
16396153|NCT05026866|Drug|Donanemab|Administered intravenously
16396154|NCT05026866|Drug|Placebo|Administered intravenously
16396155|NCT05025735|Drug|Dapagliflozin 10Mg Tab|"Hyperglycemia is an expected effect of PI3K inhibitors given the pivotal role of PI3K in mediating the response to insulin in multiple tissues. Blocking insulin signaling by p110α inhibitors leads to glycogen breakdown in the liver along with decreased glucose uptake in peripheral tissues. The resulting hyperglycemia causes a compensatory response of increase insulin secretion by the pancreas.
~If concurrent treatment with dapagliflozin can abrogate the alpelisib induced hyperglycemia and subsequent rebound hyperinsulinemia it may significantly improve the therapeutic efficacy of alpelisib."
16396156|NCT05025449|Diagnostic Test|Focused Assessment with Sonography for Trauma (FAST)|The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam.
16396157|NCT05025449|Drug|Bubble-Enhanced FAST (BEFAST)|Following the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. Contrast may be redosed if images are inadequate or incomplete. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by AAST criteria.
16396158|NCT05025280|Other|Adolescent/Adult Sensory Profile Questionnaire|"The Adolescent/Adult Sensory Profile Questionnaire (AASP), was developed based on Dunn's model of sensory processing. It is a 60-item self-assessment questionnaire that evaluates behavioral patterns related to sensory processing. The questionnaire consists of six different subsections such as taste/smell processing, movement processing, visual processing, touch processing, auditory processing, and activity level. According to the answers given, individuals are evaluated in 4 quartiles as low registration, sensory sensitivity, sensation avoiding, and sensation seeking."
16396159|NCT05023629|Other|Intracoronary balloon inflation|Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.
16396160|NCT05023395|Drug|MEE-HU Medicus|This investigational medicinal product (MEE-HU Medicus) is a patented mixture of amino acids and pentose sugar. The mixture according to the invention in particular is suitable as medicine for resistance-breaking of antibiotic resistances of pathogens, in particular for resistance-breaking of multiple antibiotic resistances, a method for decreasing bacterial resistance to antibiotics.
16396161|NCT05023395|Other|Placebo|Placebo
16396174|NCT05014412|Drug|Elranatamab|BCMA-CD3 bispecific antibody
16396175|NCT05013086|Drug|1.11 GBq of 177Lu-AB-3PRGD2|accepted intravenous injection of 177Lu-AB-3PRGD2
16396177|NCT05011279|Other|Move Together app/Garmin Activity Tracker|"The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links.
~Garmin activity tracker in this study is for participants to track their steps and sedentary time."
16396178|NCT05011162|Device|Digital ACT|Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT).
16396179|NCT05010993|Diagnostic Test|Nine Hole Peg Test|Each person will be tested by the Nine Hole Peg Test (3 attempts per subtest)
16396180|NCT05010993|Diagnostic Test|Purdue Pegboard Test|Each person will be tested by the Purdue Pegboard Test (3 attempts per subtest)
16396181|NCT05010993|Diagnostic Test|Box and Block Test|Each person will be tested by the Box and Block Test (3 attempts per subtest)
16396182|NCT05010512|Device|Delefilcon A contact lenses|Commercially available silicone hydrogel contact lenses used as indicated
16396183|NCT05010512|Device|Kalifilcon A contact lenses|Commercially available silicone hydrogel contact lenses used as indicated
16396188|NCT05009069|Radiation|Radiotherapy|Weeks 1-5: 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
16396189|NCT05009069|Drug|Capecitabine|Weeks 1-5: Capecitabine 825 mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy.
16396190|NCT05009069|Drug|Fluorouracil|Weeks 1-5: fluorouracil (5-FU) 225 mg/m^2 intravenously (IV) over 24 hours 5 days/week during radiotherapy.
16396191|NCT05009069|Drug|Atezolizumab|Weeks 8, 11 and 14: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle for 3 cycles.
16396192|NCT05009069|Drug|Tiragolumab|Weeks 8, 11 and 14: Tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 3 cycles.
16396193|NCT05005871|Other|Quadratus lumborum block after C-section surgery as postoperative pain management|To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
16396194|NCT05005351|Device|Digital ACT 1|Participants in Digital ACT Group 1 complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
16396195|NCT05005351|Device|Digital ACT 2|Participants in Digital ACT Group 2 complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
16396196|NCT05005351|Other|Digital Symptom Tracker|Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.
16396200|NCT05002881|Other|Moringa oleifera (E-HS-01)|One capsule to be taken stat
16396201|NCT05002881|Other|Placebo|One capsule to be taken stat
16396202|NCT05002816|Drug|Elotuzumab|Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days.
16396203|NCT05002816|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered via IV infusion. There will be 2 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be teste
16396204|NCT04994132|Drug|Cyclophosphamide|Given IV or PO
16396205|NCT04994132|Biological|Dactinomycin|Given IV
16396206|NCT04994132|Radiation|Radiation Therapy|Undergo radiation therapy
16396207|NCT04994132|Drug|Vincristine Sulfate|Given IV
16396208|NCT04994132|Drug|Vinorelbine Tartrate|Given IV
16396209|NCT04992884|Device|Gastric Alimetry|Gastric Alimetry is a medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders. The device is indicated for use during the diagnostic work-up of patients reporting gastric symptoms, who are suspected of having an underlying gastric motility problem.
16396210|NCT04990219|Drug|Lu AG06466|Lu AG06466 - capsule
16396211|NCT04990219|Drug|Placebo|Placebo - capsule
16396212|NCT04989595|Device|MyIUS app|Data will be self-reported by participants through the MyIUS app.
16396215|NCT04982718|Diagnostic Test|OraQuick® HCV Self-Test|"Self-testing will be performed using the OraQuick® HCV Self-Test manufactured by OraSure Technologies Inc., USA. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the OraQuick® HCV Rapid Antibody Test is prequalified by WHO and CE marked for professional use (sensitivity 98.1%, specificity 99.6%).
~As it is not approved for self-test use in Malaysia, the OraQuick® HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management."
16396216|NCT04982718|Diagnostic Test|First Response® HCV Self-Test|"Self-testing will be performed using the First Response® HCV Card Test (Self Test) manufactured by Premier Medical Corporation, India. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the First Response® HCV Card Test is CE-marked and currently under WHO review for professional use (sensitivity 100%, specificity 100%).
~As it is not approved for self-test use in Malaysia, the First Response® HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management."
16396217|NCT04981431|Drug|Elinzanetant (BAY3427080)|Oral administration
16396218|NCT04981431|Drug|Placebo|Oral administration
16396219|NCT04981119|Other|Leukapheresis|Leukapheresis procedure performed for collection of PBMCs.
16396220|NCT04981119|Diagnostic Test|Next Generation Sequencing (NGS)|NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
16396221|NCT04981119|Diagnostic Test|Long Range NGS HLA typing|Long range NGS on whole blood to determine germline HLA type.
16396222|NCT04976933|Behavioral|mHealth adherence app|The mHealth app is designed to remind caregivers to give medication in the outpatient setting, track adherence, and capture real time barriers to adherence if medication is missed.
16396223|NCT04976530|Device|DrugSorb-ATR system|Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
16396224|NCT04976530|Device|Sham comparator|Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
16396225|NCT04973202|Other|Stay for alcohol detoxification|Stay for alcohol detoxification : routine care.
16396226|NCT04969835|Drug|AVA6000|AVA6000 is a FAP-activated prodrug of doxorubicin. AVA6000 will be administered via IV infusion every 3 weeks. Dosing will occur based on the calculated patient's BSA on the day of dosing.
16396227|NCT04967287|Device|MyopiaX|MyopiaX treatment twice a day
16396228|NCT04967287|Device|Sham|Sham device usage twice a day
16396229|NCT04965337|Drug|ASC42|ASC42 tablet administered orally
16396230|NCT04965337|Drug|Placebo|Matching placebo administered orally
16396231|NCT04964557|Drug|AZD8233|PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
16396232|NCT04964557|Drug|Placebo|Placebo solution
16396233|NCT04963543|Other|FID123238|Lubricant applied to the ocular surface
16396234|NCT04962594|Other|Experimental formulas (EF)|First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months
16396235|NCT04962594|Other|Control formulas (CF)|First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months
16396236|NCT04962594|Other|Breast feeding (BF)|Exclusive breast feeding up to 4 months
16396240|NCT04961814|Diagnostic Test|gastric ultrasound|preoperative gastric ultrasound will be done for all patients to estimate gastric volume by measuring the antral cross sectional area and also, know the type of gastric content
16396241|NCT04961034|Procedure|kasai portoenterostomy|surgical creation of stoma between porta hepatis and jejunal loop
16396242|NCT04960748|Behavioral|WOMEN FIGHTING TO STOP CERVICAL CANCER|The group intervention draws on theories of social diffusion, cognitive consistency, and social influence, and our own recently developed and tested group intervention that mobilized people living with HIV in Uganda to successfully act as change agents for HIV prevention within their social networks. The intervention actively targets internalized stigma, disclosure decision making, healthy living, and advocacy communication skills. The ultimate goal of the program is to encourage female social network members to get screened for cervical cancer.
16396246|NCT04957953|Other|Patient's consent|Primary enrolment will be carried out at the time of vaccination at the main vaccination sites, with the patient's consent. The agreement form filled in online includes the surname, first name, month and year of birth. This form serves as an agreement to participate in the study.
16396247|NCT04957953|Other|Inclusion form|"This form includes the date of the last menstrual period, vaccination data (type of vaccine, date of vaccination, 1st or 2nd injection, etc.), socio-demographic data of the pregnant woman, medical and surgical history, gynaecological and obstetrical history, a description of the current pregnancy, and the medication taken by the patient during her pregnancy....
~A link to complete this form (with the unique identifier) will be sent to each woman included who has given her consent to participate."
16396248|NCT04957953|Other|Adverse reaction report form.|One month after each injection of the vaccine, information will be collected on any vaccination-related adverse reactions that may impact the pregnancy (fever, hypertension, etc.) or on the onset of a Covid-19 infection,
16396249|NCT04957953|Diagnostic Test|Follow-up report form.|In the 2 months following the expected delivery date, information will be collected on the outcome of the pregnancy (delivery, spontaneous abortion, etc.) and maternal clinical signs (pre-eclampsia, gestational hypertension, gestational diabetes, etc.). Before sending the link to this form, information will be sent to the second holder of parental authority. In the absence of opposition, data on the newborn will be collected (sex, height, weight, head circumference, Apgar, malformation, neonatal pathology, etc.)
16396250|NCT04951336|Dietary Supplement|FoTv|Fomitopsis Officinalis and Trametes Versicolor
16396253|NCT04949789|Other|Placebo without Exercise|2 Capsules to be taken 30 minutes before breakfast.
16396254|NCT04949789|Other|Placebo with Exercise|2 Capsules to be taken 30 minutes before breakfast.
16396255|NCT04949789|Other|IP I|2 Capsules to be taken 30 minutes before breakfast.
16396256|NCT04949789|Other|IP II|2 Capsules to be taken 30 minutes before breakfast.
16396257|NCT04949789|Other|IP III|2 Capsules to be taken 30 minutes before breakfast.
16396258|NCT04948554|Drug|ACE-1334|ACE-1334 is a recombinant homodimeric Fc fusion protein comprising of the extracellular domain (ECD) of the human TGF-βRII, linked to a modified human Fc domain of IgG1
16396259|NCT04948554|Drug|Placebo|Placebo: matching placebo
16396260|NCT04943341|Procedure|Eco-guided Triamcinolone-Acetonide injection|"The treatment consists in injecting 1 ml of Kenacort (corresponding to 40 mg of Triamcinolone Acetonide) diluted in about 1 ml of local anesthetic (Lidocaine) directly into the medial fold of the knee. Through an ultrasound guidance with in plane technique, the flute beak of the needle will be positioned between the two sheets of the synovial fold and the injection will be performed."
16396261|NCT04942405|Biological|TURCOVAC|Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,28
16396262|NCT04942405|Biological|CoronaVac|Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28
16396263|NCT04941040|Drug|Opioid free anesthetics|"Patients will receive over the 10 minutes prior to induction:
~Acetaminophen 1 gm i.v. infusion in 100ml over 10 minutes.
~Ketorolac 30 mg i.v. infusion in100 ml over 10 minutes.
~Mg SO4 loading dose 30 mg/kg i.v. infusion in 100 ml over 10 minutes.
~Dexmedetomidine loading dose 1 μg/kg i.v. infusion.
~Lidocaine loading dose 1.5 mg/kg i.v. infusion.
~Ketamine loading dose 0.25 mg/kg i.v. infusion.
~The weight based doses of dexmedetomidine, lidocaine, ketamine will be prepared on 20 ml syringe and infused over 10 minutes prior to induction. In a dose of 0.1 ml/kg
~Then after induction maintenance analgesic infusion will start in a rate that ranges from 0.025 to 0.05 ml/kg/h which is equivalent to:
~Dexmedetomidine 0.25-0.5 μg/kg/h
~Lidocaine 0.375-0.75 mg/kg/h
~Ketamine 0.0625- 0.125 mg/kg/h"
16396264|NCT04941040|Drug|Opioid Anesthetics|Placebo equivalent to acetaminophen, ketorolac, magnesium sulphate will be infused as 100 ml normal saline each over 10 minutes ,patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h.
16396265|NCT04938830|Biological|MK-1654|IM injection
16396266|NCT04938830|Biological|Palivizumab|IM injection
16396267|NCT04937374|Other|Rehmannia glutinosa leaf extract|One capsule to be taken after breakfast.
16396268|NCT04937374|Other|Microcrystalline Cellulose (MCC)|One capsule to be taken after breakfast.
16396269|NCT04936516|Device|Endotracheal intubation|Endotracheal intubation using either McGrath or C-MAC video laryngoscopy
16396270|NCT04935060|Behavioral|A guide to inform the process of delivering the outcomes of a dementia assessment|The guide provides information that informs the approach taken to assessing people for dementia. It aims to guide clinicians. patients and their companions to think about how the diagnostic process is carried out, taking into account patient preferences, particularly around how they would like diagnostic decisions to be communicated to them.
16396271|NCT04935060|Behavioral|Usual Care|Clinicians conduct the dementia assessment as per standard protocols
16396272|NCT04934410|Drug|Etomidate|Use of etomidate during induction as decided by attending anesthesiologist
16396273|NCT04934410|Drug|Midazolam|Use of midazolam during induction as decided by attending anesthesiologist
16396274|NCT04934410|Drug|Sevoflurane|Use of sevoflurane during induction as decided by attending anesthesiologist
16396405|NCT04821310|Drug|Half Dose Pantoprazole plus matching placebo|Half healing dose of pantoprazole plus matching placebo
16396285|NCT04931654|Drug|AZD7789|anti-PD-1 and anti-TIM-3 bispecific antibody
16396287|NCT04923620|Drug|cetuximab+mFOLFOX6|cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
16396288|NCT04923620|Radiation|short-course radiotherapy|25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6
16396291|NCT04920383|Drug|ALPN-202|Various doses
16396292|NCT04920383|Drug|Pembrolizumab|Varies
16396293|NCT04918927|Drug|Favipiravir|Oral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7
16396294|NCT04918927|Drug|Nitazoxanide|Nitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7
16396295|NCT04918927|Other|Nitazoxanide Placebo|Nitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7.
16396296|NCT04917809|Drug|Erdafitinib|Participants will receive erdafitinib at a dose of 6 mg orally once daily for the first 14 days (±3 days). Serum phosphate levels will be assessed on day 14 (±3 days). No up-titration will be done regardless of serum phosphate level. If there are no significant toxicity, participants will continue on a dose of 6 mg orally once daily until the day of standard-of-care TURBT/biopsy. Participants with a serum phosphate level between 7.0 and 9.0 mg/dL (2.3 mmol/L to 2.9 mmol/L) will continue on 6 mg once daily while concurrently initiating treatment with a phosphate binder until the day of their standard-of-care TURBT/biopsy. Standard-of-care TURBT/biopsy will be performed after approximately 28 days (±5 days) of treatment with erdafitinib, and biologic and pathologic tumor response will be assessed. All participants will then be followed up for recurrence or progression in accordance with the standard of care.
16396297|NCT04915352|Drug|Nasal provocation test - 725 Dermatophagoides Pteronyssinus|"3 different concentrations of Nasal Provocation Test are administered to patients:
~Nasal spray at 50 SBE/ml for 36 months
~Nasal spray at 500 SBE/ml for 36 months
~Nasal spray at 5000 SBE/ml for 36 months"
16396298|NCT04915352|Other|Negative control|Negative control using only solvent is applied in order to consider a non-specific nasal hyper reactivity.
16396301|NCT04912674|Device|Symphony OCT System|Surgical intervention will be patient specified by treating surgeon.
16396302|NCT04911257|Device|Cervical or Lumbar Spinal fusion|This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.
16396303|NCT04911218|Device|GlideSheath Slender 5Fr arterial sheath|Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
16396304|NCT04911218|Device|Conventional 5Fr arterial sheath|Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
16396305|NCT04910243|Other|Questionnaire Survey|Physicians providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic will be questioned by electronic web-based survey within Masaryk University information system.
16396306|NCT04905836|Biological|COVI-MSC|COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
16396307|NCT04905836|Drug|Placebo|Excipient solution
16396312|NCT04897607|Behavioral|Standard Care|Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.
16396313|NCT04897607|Behavioral|Precision pharmacotherapy|Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication.
16396314|NCT04896645|Device|Digihaler Albuterol Device by TEVA|Patient with asthma will have their regular albuterol rescue inhaler replaced with Digihaler, they will also be asked to perform gamified spirometry (Aluna) at home
16396315|NCT04896333|Other|Interaction and exposure with the Robot EBO|The participants will interact with the Robot EBO. The robot will be control by an operator that will conduct a dialogue. The dialogue will include questions related to the social, leisure, activities of daily living and informative areas.
16396317|NCT04893811|Biological|Trumenba|Bivalent recombinant lipoprotein 2086 vaccine
16396321|NCT04889846|Procedure|SAFE early intervention approach|SAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.
16396322|NCT04889573|Genetic|Blood sample|The blood samples will be collected from healthy volunteers : 7 tubes of 7 ml with anti-coagulant Héparine Lithium and 1 tube of 7ml with anti-coagulant EDTA
16396323|NCT04889430|Drug|Iptacopan|Iptacopan 200mg twice daily oral
16396324|NCT04888494|Device|Transcranial Magnetic Stimulation|For the brain stimulation the investigators will use Repetitive Transcranial Magnetic stimulation (rTMS). Different stimulation conditions (hippocampal or sham) will be delivered in each round of stimulation (5 days). Repetitive TMS will be applied at 100% resting motor threshold intensity, 20 Hz pulse trains separated by 28-s inter-train intervals (~20 minutes for the entire daily stimulation session). Stimulation parameters will be identical in both groups
16396325|NCT04888494|Device|Sham rTMS|Sham rTMS
16396326|NCT04887688|Device|exciflex|untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.
16396327|NCT04882917|Drug|M4076|M4076 will be administered orally, in Part 1A and Part 1B.
16396329|NCT04881448|Diagnostic Test|collection of serum/capillary creatinine values|collection of serum/capillary creatinine values
16396330|NCT04880928|Drug|Eye injection (Mydrane)|"Mydrane 0.2 mg/ml + 3.1 mg/ml
~+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride"
16396331|NCT04880928|Drug|eye drops (Phenylephrin)|Phenylephrine 10%
16396332|NCT04880928|Drug|eye drops (Tropicamid)|Tropicamid 0,5%
16396333|NCT04880447|Biological|BNT162b2|COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.
16396334|NCT04875533|Biological|20vPnC|20vPnC
16396335|NCT04875533|Other|Saline|Saline
16396336|NCT04875533|Biological|13vPnC|Pneumococcal conjugate vaccine
16396337|NCT04875533|Biological|PPSV23|Pneumococcal polysaccharide vaccine
16396338|NCT04874636|Drug|LY3556050|Administered orally
16396339|NCT04874636|Drug|Placebo|Administered orally
16396340|NCT04873297|Drug|Metoclopramide 10mg|Tab. Metoclopramide 10mg TDS via NG tube
16396341|NCT04873297|Drug|Placebo|Placebo 10 ml of plain water Via NG
16396342|NCT04871711|Drug|Delgocitinib cream|Cream for topical application
16396343|NCT04871711|Drug|Cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
16396344|NCT04871607|Biological|Basiliximab|Anti-CD25 antibody given IV
16396345|NCT04871607|Drug|Carmustine|Cytotoxic chemotherapy; alkylating agent given IV
16396346|NCT04871607|Drug|Cytarabine|Cytotoxic chemotherapy; antimetabolite given IV
16396347|NCT04871607|Drug|Etoposide|Cytotoxic chemotherapy; topoisomerase II inhibitor given IV
16396348|NCT04871607|Procedure|Autologous stem cell transplantation|Patients will receive their own stem cells, collected prior to conditioning given via IV infusion
16396349|NCT04871607|Radiation|Yttrium - 90 Basiliximab|Radio-conjugate of anti-CD25 antibody given IV
16396352|NCT04869228|Drug|GT0918 tablets or placebo|GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals
16396355|NCT04866160|Drug|BI 1291583|BI 1291583
16396356|NCT04866160|Drug|Placebo|Placebo
16396357|NCT04862429|Other|Contrast enhanced mammography guided biopsy (diagnostic procedure)|With visible contrast-enhancement, stereotactic biopsy will be performed under CESM guidance. After administration of an additional dose of iodized contrast-enhancement (Omnipaque), the insertion of the biopsy needle and the biopsy sampling will be targeted on the area of greatest enhancement in the context of calcifications. In the absence of contrast-enhancement, stereotactic biopsy Mammotome will be performed, using X-ray guidance. The insertion of the biopsy needle and biopsy will be targeted on the most suspicious calcification cluster or area. At the end of the procedure, a metal clip marker will be placed in the biopsy site; the placement will be verified with dual orthogonal mammography projection (as regular clinical practice).
16396358|NCT04862429|Other|Mammography guided biopsy (diagnostic procedure)|"For all lesions, stereotactic biopsy Mammotome will be performed, using X-ray guidance. The insertion of the biopsy needle and biopsy will be targeted on the most suspicious calcification cluster or area.
~At the end of the procedure, a metal clip marker will be placed in the biopsy site; the placement will be verified with dual orthogonal mammography projection (as regular clinical practice)."
16396359|NCT04862195|Device|Attune™|Software as a medical device
16396360|NCT04862195|Device|Cerena™|Software as a medical device
16396361|NCT04859972|Diagnostic Test|Diagnosis of IBS|Diagnosis of IBS according to ICD-10
16396406|NCT04819568|Drug|Terlipressin|Terlipressin Bolus Max dose 2 mg/24 hr.i.e 0.5 mg qid
16396407|NCT04819568|Other|Standard of Care|Standard of Care
16396363|NCT04858711|Drug|ketamine-lidocaine-dexmedetomidine|In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.
16396364|NCT04858711|Drug|fentanyl|In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.
16396367|NCT04857996|Drug|UBX1325|Patients will be administered a single 50 μL UBX1325 IVT injection
16396368|NCT04857996|Other|Sham|Sham procedure
16396369|NCT04852861|Diagnostic Test|immunogenicity after first and second dose|Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
16396370|NCT04852224|Drug|Androgen deprivation therapy|Prostate cancer survivors in the ADT+ group will have been prescribed androgen deprivation therapy for a period of 6-months or more by their treating oncologist prior to consent for this study.
16396371|NCT04852133|Other|Burn subjects|see eligibility criteria
16396372|NCT04848038|Behavioral|Exercise|Standard public health exercise recommendations
16396373|NCT04847674|Drug|TEV-53275 Dose A|subcutaneous (sc) injection
16396374|NCT04847674|Drug|TEV-53275 Dose B|subcutaneous (sc) injection
16396375|NCT04847674|Drug|Placebo|Matching subcutaneous (sc) placebo injection
16396386|NCT04846881|Drug|BI 425809|BI 425809
16396387|NCT04846881|Drug|Placebo|Placebo
16396388|NCT04846868|Drug|BI 425809|BI 425809
16396389|NCT04846868|Drug|Placebo|Placebo
16396390|NCT04844450|Drug|JNJ-75220795|JNJ-75220795 will be administered subcutaneously.
16396391|NCT04844450|Drug|Placebo|Matching placebo will be administered subcutaneously.
16396392|NCT04842747|Drug|VERU-111|Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.
16396395|NCT04838626|Drug|[18F]CTT1057|PET/CT imaging with [18F]CTT1057
16396396|NCT04837365|Other|Three dimensional gait analysis with eyetracking|An emotional impregnation and eye pursuit assessment are specific to the study. Emotional impregnation involves making the patient look at images from the International Affective Picture System (IAPS) on a screen before initiating walking. The equipment will be identical to that of the patient during walking tasks. Eye movement analysis is performed using a pair of eyetracking glasses.
16396397|NCT04835441|Drug|ALPN-101|Blinded ALPN-101 will be administered
16396398|NCT04835441|Drug|Placebo|Blinded placebo matching ALPN-101 will be administered.
16396400|NCT04826484|Drug|Exparel 133 MG Per 10 ML Injection|Local wound infiltration with Exparel 133 MG Per 10 ML Injection.
16396401|NCT04826484|Drug|Bupivacaine Hydrochloride|Local wound infiltration with 0.25% standard bupivacaine.
16396404|NCT04821310|Drug|Full dose Pantoprazole plus matching placebo|Full healing dose of pantoprazole plus matching placebo
16396413|NCT04815031|Biological|BNT162b2|Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose. Individuals 16 years of age and older.
16396414|NCT04812483|Drug|Eltrombopag (Revolade®)|Eltrombopag is a thrombopoietin receptor agonist (TPO-RA) indicated in patients with ITP refractory to first-line drugs or lasting more than 6 months. Administration of Eltrombopag (Revolade®), 50 mg PO, from day 5-140. Tapering over 1 week from day 141-148 with 50 mg every second day.
16396415|NCT04812483|Drug|standard therapy (without eltrombopag): HD-DXM|standard therapy (without eltrombopag): HD-DXM administered orally (40 mg) from day 1-4
16396416|NCT04810793|Drug|Amoxicillin , Levofloxacin and Esomeprazole|Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
16396417|NCT04810793|Drug|Amoxicillin , Furazolidone and Esomeprazole|Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
16396418|NCT04810793|Drug|Tetracycline , Furazolidone and Esomeprazole|Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
16396419|NCT04810793|Drug|Amoxicillin,Levofloxacin and Vonoprazan fumarate|Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
16396420|NCT04810793|Drug|Amoxicillin,Furazolidone and Vonoprazan fumarate|Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
16396421|NCT04810793|Drug|Tetracycline,Furazolidone and Vonoprazan fumarate|Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group
16396422|NCT04809766|Biological|Autologous Mesothelin-specific TCR-T Cells|Receive FH-TCR Tᴍsʟɴ IV escalating doses
16396423|NCT04809766|Drug|Cyclophosphamide|Given IV dose
16396424|NCT04809766|Drug|Fludarabine|Given IV dose
16396426|NCT04806074|Behavioral|Experimental Group|Evidence-based food-related national and international guidelines were (i) specifically arranged considering the Food Literacy Wheel (Rosas et al., 2021) and personalised materials contained these guidelines were designed, (ii) matched with tailored behaviour change techniques (BCT Taxonomy v1, by Michie et al., XXXX) that indicated how to develop/implement each competence/behaviour, and (iii) digitally delivered weekly. Psychological variables of the Health Action Process Approach model (HAPA; Schwarzer, 2008) were integrated in the intervention, to study potential food literacy's psychological determinants. Weekly introduction videos featuring the lead psychologist were made available. Participants' groups in WhatsApp were built to incentive experience-sharing. Food literacy domains and HAPA determinants were assessed weekly, post-intervention, and in follow-up moments 3-, 6- and 9-months after the intervention.
16396427|NCT04806074|Behavioral|Comparison Group|Food-related guidelines were delivered in a single moment in the first week of the intervention, on their original format and referring their original source (national's and international's entities websites). There was not a thematic for each specific week. No weekly introduction videos or WhatsApp groups existed in this condition. Food literacy domains and HAPA determinants were assessed weekly, post-intervention, and in follow-up moments 3-, 6- and 9-months after the intervention.
16396428|NCT04804787|Diagnostic Test|Carrying out a tests and questionnaires battery|The attendees will carry out different questionnaires and tests to evaluate their potential cognitive disorders
16396429|NCT04802759|Drug|Giredestrant|30 milligrams (mg) orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
16396430|NCT04802759|Drug|Abemaciclib|150 mg orally twice a day during each 28-day cycle until unacceptable toxicity or disease progression
16396431|NCT04802759|Drug|Ipatasertib|400 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression
16396432|NCT04802759|Drug|Inavolisib|9 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
16396433|NCT04802759|Drug|Ribociclib|600 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression
16396434|NCT04802759|Drug|Everolimus|10 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
16396445|NCT04795245|Drug|afatinib|afatinib
16396446|NCT04794530|Drug|cocoa flavanols|The cocoa flavanols intervention is manufactured by Mars Inc. Participants randomized to cocoa flavanols will take two capsules daily of cocoa flavanols. The two capsules of cocoa flavanols will contain approximately 500 mg of cocoa flavanols and appoximately 80 mg of (-)-epicatechin.
16396447|NCT04794530|Drug|placebo|The placebo intervention will be manufactured by Mars Inc. and will appear identical to the cocoa flavanols intervention. Participants will take two capsules daily of placebo. The placebo will be a cellulose based capsule and will not contain cocoa flavanols or (-)-epicatechin.
16396448|NCT04792892|Other|Questionnaires|Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months
16396488|NCT04756531|Drug|PF-07321332 Dose 5|PF-07321332 Dose 5 or Placebo
16396489|NCT04756531|Drug|PF-07321332 Dose 4 or Placebo (Fed)|PF-07321332 Dose 5 or Placebo with high fat meal
16396449|NCT04791228|Device|Magnetic Resonance-Guided High Intensity Focused Ultrasound|"Magnetic resonance (MR)-guided high intensity focused ultrasound (HIFU) provides precise and controlled delivery of heat by focusing ultrasound energy inside a lesion using an external applicator without the need for a scalpel or needle.
~Additional therapeutic advantages of this modality include its range of bioeffects, including both high temperature tumor ablation via coagulative necrosis, and effects of lower temperature, mild hyperthermia that can help to enhance local drug delivery to tumors. Both tumor ablation and hyperthermia may be employed to potentiate the effects of chemotherapy."
16396450|NCT04791228|Drug|Lyso-thermosensitive Liposomal Doxorubicin|"LTLD combines doxorubicin with lyso-thermosensitive liposomes that can selectively deliver drug to tumors and when exposed to temperatures greater than 40°C, rapidly and locally releases doxorubicin in high concentrations from systemically administered LTLD.
~If combined with hyperthermia, doxorubicin will be released in the heated tumor margins and in any areas within the tumor that were not completely ablated and increase the likelihood of complete tumor necrosis. LTLD will extend tumor cell death to the hyperthermic regions in the peri-ablation zones and minimize the possibility of incomplete ablation or tumor recurrence."
16396453|NCT04778397|Biological|Magrolimab|Administered intravenously (IV).
16396454|NCT04778397|Drug|Venetoclax|Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).
16396455|NCT04778397|Drug|Azacitidine|Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
16396456|NCT04778397|Drug|Cytarabine|"Induction: administered continuous infusion, 100 or 200 mg/m^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days).
~Consolidation: administered IV, 3000 mg/m^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles."
16396457|NCT04778397|Drug|Daunorubicin|Administered IV peripherally (IVP), 60 mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
16396458|NCT04778397|Drug|Idarubicin|Administered IV, 12 mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
16396459|NCT04778397|Drug|Steroidal Eye Drops|Administered per institutional standard during consolidation.
16396460|NCT04775082|Drug|Liraglutide|"The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
~The dose will increase each week over 4 or 5 weeks until the final dose is reached."
16396461|NCT04775082|Drug|Placebo|The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
16396462|NCT04773353|Drug|Follitropin Delta (FE 999049)|FE 999049 will be administered as single daily subcutaneous injections in the abdomen. Subjects randomized to FE 999049 will have their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For subjects with low AMH (<15 pmol/L) the daily FE 999049 dose will be 12 μg, irrespective of body weight. For subjects with high AMH (≥15 pmol/L) the daily FE 999049 dose will be on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight.The daily FE 999049 dose will be fixed throughout the stimulation period and maximum allowed daily dose will be 12 μg. Subjects could be treated for a maximum of 20 days.
16396463|NCT04773353|Drug|Follitropin Alfa (GONAL-F)|GONAL-F will be administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F will be 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose will be 450 IU. Subjects could be treated for a maximum of 20 days.
16396464|NCT04771819|Device|SWIS|Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.
16396465|NCT04771273|Drug|BI 456906|BI 456906
16396466|NCT04771273|Drug|Placebo|Placebo
16396467|NCT04768101|Drug|[11C]-PIB|[11C]-PIB is a PET radiotracer used to evaluate levels of Αβ burden.
16396468|NCT04763902|Behavioral|Time Restricted Eating (TRE) Schedule|[See arm/group descriptions]
16396481|NCT04758780|Drug|89Zr-TLX250 PET/CT|Pretherapeutic 89Zr-TLX250 PET/CT
16396482|NCT04757649|Behavioral|Safety Planning Intervention with Navigation Services|A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).
16396483|NCT04756687|Drug|Dimethyl fumarate|Administered as specified in the treatment arm.
16396484|NCT04756531|Drug|PF-07321332 Dose 1|PF-07321332 Dose 1 or Placebo
16396485|NCT04756531|Drug|PF-07321332 Dose 2|PF-07321332 Dose 2 or Placebo
16396486|NCT04756531|Drug|PF-07321332 Dose 3|PF-07321332 Dose 3 or Placebo
16396487|NCT04756531|Drug|PF-07321332 Dose 4|PF-07321332 Dose 4 or Placebo
16396490|NCT04754360|Other|Evaluation of functional impairment|Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test
16396491|NCT04754360|Other|Evaluation of pulmonary function|Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.
16396492|NCT04754360|Other|Evaluation of quality of life|Quality of life will be evaluated using Short Form-36 Questionnaire.
16396493|NCT04754360|Other|Evaluation of physical activity level|Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form
16396502|NCT04750577|Other|Placebo|Matching placebo
16396503|NCT04750577|Drug|BI 685509|BI 685509
16396504|NCT04749173|Drug|DWRX2003|Drug: Placebo Intramuscularly injection at predefined injection sites
16396505|NCT04744454|Drug|Isauvuconazole group|Patients who are treated with Isavuconazole according to its protocol label.
16396507|NCT04733924|Other|Aqueous extract of roots plus leaves of Withania somnifera 125 mg|One capsule before breakfast for 84 days
16396508|NCT04733924|Other|Aqueous extract of roots plus leaves of Withania somnifera 250 mg|One capsule before breakfast for 84 days
16396509|NCT04733924|Other|Microcrystalline Cellulose|One capsule before breakfast for 84 days
16396510|NCT04728633|Drug|Carmustine|Given via infusion
16396511|NCT04728633|Drug|Ethiodized Oil|Given via infusion
16396512|NCT04728633|Procedure|Transarterial Chemoembolization|Undergo TACE
16396513|NCT04728633|Other|Medical Device Usage and Evaluation|Given gelatin sponge via injection
16396514|NCT04725864|Drug|Progesterone vaginal tablet|The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.
16396515|NCT04723667|Behavioral|13-week multimodal intervention|The experimental intervention was a 13-week multimodal intervention consists of five-weekly, 90-minute, face-to-face sessions to be delivered in a group format (six to eight participants per group), followed by two weekly and three biweekly telephone follow-ups. The five face-to-face sessions covered brain health information, booster memory power, reducing stressors, optimizing strength and active lifestyle engagement.
16396516|NCT04723667|Behavioral|5-week health education programme|The health education program consisted of three topics (fall prevention, oral care and home hygiene), with two tele-booster follow up
16396517|NCT04722250|Device|Medtronic Evolut PRO or Evolut PRO+ TAV Systems|TAVR treatment with Medtronic Evolut PRO or PRO+ System
16396518|NCT04722250|Device|Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems|TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
16396519|NCT04720664|Drug|SM-88|"SM-88, Two 230 mg capsules taken orally twice daily (920 mg daily).
~Methoxsalen, One 10 mg capsule taken orally once daily.
~Phenytoin, One 50 mg tablet taken orally once daily.
~Sirolimus, One 0.5 mg tablet taken orally once daily."
16396520|NCT04715984|Procedure|Neural stimulation|For a subset of study participants, neural stimulation will be performed during deep brain stimulation cases performed as routine clinical care for movement disorders. Stimulation will be performed both at rest and during neurocognitive tasks. Subjects will additionally be asked to complete two questionnaires, the Beck Depression Inventory II (BDI-II) and the Montreal Cognitive Assessment (MOCA)
16396521|NCT04715984|Other|Observational Microelectrode and Local Field Potential (LFP) Recordings|"All study participants, both Parkinson's and non-Parkinson's movement disorder patients, will receive microelectrode and local field potential (LFP) recordings obtained during rest and during a neurocognitive task, which tests working memory and/or response inhibition.
~Microelectrode recordings will use the clinical microelectrodes to guide clinical electrode placement to record from structures along the planned electrode trajectory. Cortical LFP recording will be an optional portion of the study that will use a 4-8 contact strip electrode to record from the surface of the brain exposed by the burr hole created to allow introduction of clinical electrodes. Once recording electrodes are in place, we will perform resting state recordings for 3-5 minutes with the subject resting quietly with their eyes open. Following this, the subject will participate in a neurocognitive task while we continue to record from the electrodes."
16396522|NCT04715126|Other|Oxyjun|One capsule to be taken after breakfast with water.
16396523|NCT04715126|Other|Placebo|One capsule to be taken after breakfast with water.
16396524|NCT04713449|Other|Empowered Survivor Online|Informational online intervention for head and neck cancer survivors
16396525|NCT04713449|Other|Springboard Beyond Cancer|Informational online intervention for all cancer survivors
16396526|NCT04713449|Other|Survey Administration|Survey measures administered at BL, two and 6 months post-baseline
16396531|NCT04707248|Drug|DS-6000a|Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1
16396532|NCT04707248|Drug|DS-6000a|Intravenous administration at RDE on Day 1 of Cycle 1
16396533|NCT04707157|Drug|LY3556050|given orally
16396534|NCT04707157|Drug|Placebo|given orally
16396535|NCT04704154|Drug|Regorafenib, (Stivarga, BAY73-4506)|"Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).
~If the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets)."
16396536|NCT04704154|Drug|Nivolumab (Opdivo)|480 mg administered on Day 1 of each treatment cycle.
16396537|NCT04702893|Drug|Nintedanib|Nintedanib
16396538|NCT04699136|Other|6 minutes step test (ST6)|Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test
16396539|NCT04694885|Behavioral|Structured Hypnotherapy|"The Intervention includes 10 structured hypnotherapy sessions lasting 45 to 60 minutes. During hypnosis, patients reach a trance-like state comparable to a deep relaxation. The therapist guides the patient verbally and also communicates with the patient.
~Patients will be supported to use their own imagination without suggesting any imagery. By repeatedly asking what the patient is perceiving, and by verbally repeating what the patient is saying, the therapist can help the patient to go deeper into trance. In these trance states the patient learns to reduce negative side effects of the chemotherapy and increase the quality of life by activating both physical and mental resources using imagination and focusing on positive memories and feelings."
16396540|NCT04693767|Other|Mechanical thrombectomy|"Clot specimen collection
~Extracranial blood collection"
16396541|NCT04693767|Other|Minimally invasive surgery|"Clot specimen collection
~Arterial blood collection"
16396542|NCT04693351|Drug|Troriluzole|Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
16396543|NCT04693351|Drug|Placebo|Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
16396554|NCT04684368|Drug|Carboplatin|Given IV
16396555|NCT04684368|Drug|Etoposide|Given IV
16396556|NCT04684368|Biological|Filgrastim|Given subcutaneously (SC) or IV
16396557|NCT04684368|Drug|Ifosfamide|Given IV
16396558|NCT04684368|Drug|Mesna|Given IV or orally
16396559|NCT04684368|Biological|Pegfilgrastim|Given SC
16396560|NCT04684368|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplant
16396561|NCT04684368|Other|Questionnaire Administration|Ancillary studies
16396562|NCT04684368|Radiation|Radiation Therapy|Undergo WVSCI radiation therapy
16396563|NCT04684368|Radiation|Radiation Therapy|Undergo radiation therapy
16396564|NCT04684368|Procedure|Second-Look Surgery|Undergo second-look surgery if needed
16396565|NCT04684368|Drug|Thiotepa|Given IV
16396566|NCT04679467|Dietary Supplement|PKU sphere|"TYR sphere is a powdered, low phenylalanine and tyrosine protein substitute, containing a balanced mix of casein glycomacropeptide (cGMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and the long chain polyunsaturated fatty acid (LCP); Docosahexaenoic acid (DHA). It contains sugars and sweetener.
~The product is designed to be prescribed based on its protein content, not its energy content."
16396567|NCT04677179|Drug|LY3471851|administered SC
16396568|NCT04677179|Drug|LY3471851|administered SC
16396569|NCT04677179|Drug|Placebo|administered SC
16396577|NCT04661358|Drug|Fenofibrate 160mg|Participants begin with a dose of 160mg fenofibrate taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
16396578|NCT04661358|Other|Placebo|Participants begin with a dose of 160mg placebo taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
16396579|NCT04660422|Other|VitalTalk communication skills training|Clinicians will receive VitalTalk intensive communication skills training via highly structured Zoom conference. They will learn skills relevant to discussions about ACP and COVID-19 including delivering serious news, eliciting goals of care, and managing difficult conversations via telehealth platforms.
16396580|NCT04660422|Other|ACP Decisions Video Program|All clinicians will also be trained remotely on the ACP Decisions Video Program using the ACP app. Training will instruct clinicians on how to: 1. Introduce the COVID-19 videos to patients and caregivers; 2. Select the appropriate video(s) from the entire suite according to patients' needs; and, 3. Prescribe videos for patients and caregivers using the electronic platform. The suite of ACP videos is designed to address common ACP decisions confronting patients at risk or with COVID-19 and the caregivers.
16396581|NCT04660422|Other|Intervention training:|Training will instruct the clinicians on how to: i. more effectively communicate with patients regarding COVID- 19, ii. have ACP conversations with patients, iii. introduce the videos to patients and families, iv. use the videos as an adjunct to ACP counseling by clinicians, v. select the appropriate video(s) from the entire suite as according to patients' needs, and, vi. use the app or electronic platform for prescribing videos to be seen at home (telehealth visits), or to be viewed in clinic with an iPad.
16396619|NCT04611191|Other|Team Sports|The intervention involves team sports in sports clubs in local municipalities
16396582|NCT04660422|Other|Medical Record Review|13,000 (total) patients aged 65 or older for our primary (completed advance care plans) outcome. ACP can include designating a health care proxy, discussion of advance directives, goals-of-care discussions, CPR discussions, palliative care discussions and referrals, as well as hospice. Each of these ACP outcomes will also be compared in secondary analyses using NLP. These data will be obtained from the EHR. All patient participants will only be included for medical record review.
16396583|NCT04659863|Drug|Inclisiran|Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection
16396584|NCT04659863|Drug|Placebo|Sterile normal saline (0.9% sodium chloride in water for injection) for subcutaneous injection
16396585|NCT04659408|Dietary Supplement|Multistrain probiotic preparation|One sachet daily, containing 3 grams of the freeze-dried multispecies probiotic Bactosan for a period of four weeks. One sachet will be mixed with 50-100 ml water and taken daily before breakfast or dinner. Bactosan contains the following eight bacterial strains: Bifidobacterium lactis W51, Bifidobacterium lactis W52, Enterococcus faecium W54, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Lactobacillus plantarum W21, Lactobacillus salivarius W24 and Lactococcus lactis W19, with a total viable cell count of 1 × 109 cfu/gram, and therefore 3 × 109 cfu/daily dose.
16396586|NCT04659408|Dietary Supplement|Oat Bran|5 grams (one teaspoon) daily of the oat bran together with a meal of preference. The oat bran can be added to the usual breakfast cereal, yoghurt, pancakes, juice, milk, salad sauce or in an omelette.
16396587|NCT04657991|Drug|Encorafenib|Encorafenib
16396588|NCT04657991|Drug|Binimetinib|Binimetinib
16396589|NCT04657991|Drug|Pembrolizumab|Pembrolizumab
16396590|NCT04657198|Biological|RSVPreF3 OA investigational vaccine (GSK3844766A)|RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).
16396591|NCT04657003|Drug|Tirzepatide|Administered SC
16396592|NCT04657003|Other|Placebo|Administered SC
16396593|NCT04656275|Drug|BI 1323495|BI 1323495
16396594|NCT04656275|Drug|Placebo|Placebo
16396604|NCT04642079|Biological|20vPnC|20-valent pneumococcal conjugate vaccine
16396609|NCT04636879|Other|Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point|The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding message.
16396610|NCT04636879|Other|Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point|The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding
16396611|NCT04636879|Other|Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point|The subjects will received the same treatment, using dry needling in the upper trapezius fibers, at the most painful point after receiving the corresponding
16396612|NCT04631393|Drug|Propofol Alfentanil|Propofol and Alfentanil are self-administered by the participant.
16396613|NCT04627038|Drug|LY3556050|Given orally
16396614|NCT04627038|Drug|Placebo|Given orally
16396617|NCT04614103|Biological|LN-145|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
16396618|NCT04614103|Biological|LN-145|A tumor sample is harvested via core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
16396620|NCT04611191|Other|Control|The intervention involves a control condition with participants continuing their normal way of living
16396621|NCT04607889|Other|Survey|Interviews with study participants will be conducted by telephone or teleconference. The interview will focus on the participants experience with genomic tests, with the expectations, reasons for taking or declining it, hurdles encountered, satisfaction among the key themes to be discussed.
16396622|NCT04607668|Drug|Trilaciclib|Trilaciclib or placebo
16396623|NCT04607668|Drug|Placebo|dextrose 5% in water or normal saline (sodium chloride solution 0.9%)
16396624|NCT04607538|Other|No intervention is made|No intervention is made. This i an observational study.
16396633|NCT04590443|Other|NMP|Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
16396634|NCT04588428|Drug|INO-4700|INO-4700 will be administered ID.
16396635|NCT04588428|Drug|Placebo|Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
16396636|NCT04588428|Device|CELLECTRA™ 2000|EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
16396637|NCT04587518|Behavioral|Personality-Based Cognitive Behavioral Therapy|The study treatment will take place across 18-sessions. The first session will involve psychoeducation regarding BPD.The next two sessions with include exercises drawn from Behavioral Activation (i.e., identification of value-based goals) and Motivational Interviewing (i.e., pros and cons [long and short-term consequences] of tolerating emotions, engaging in prosocial behavior, and delaying gratification). Next, patients will receive 5 sessions of cognitive interventions (i.e., cognitive reappraisal related to situations/emotions, schema related to relationships, 5 sessions of behavior change skills (i.e., acting opposite to emotion-driven urges, exposure, assertiveness training), and 5 sessions of mindfulness skills (i.e., nonjudgmental emotion awareness, compassion training, urge surfing). Finally, treatment will conclude with 2 sessions of Relapse Prevention strategies. All sessions will last for 60 minutes in duration.
16396638|NCT04587024|Other|mHealth intervention|Subjects will receive mHealth direct observation of therapy for 12 weeks
16396639|NCT04587024|Other|standard of care|Subjects will receive standard of care observation for 12 weeks
16396640|NCT04585087|Other|Dietary Intakes|6 levels of threonine intake will be provided by the protein liquid drink
16396641|NCT04579757|Drug|Surufatinib and Tislelizumab _ Part 1|Part 1 (all cohorts): oral surufatinib at a dose based on cohort level and intravenous tislelizumab at a 200-mg dose
16396642|NCT04579757|Drug|Surufatinib and Tislelizumab _ Part 2|Part 2 (all cohorts): oral surufatinib at the RP2D dose selected in Part 1 and intravenous tislelizumab at a 200-mg dose
16396643|NCT04579250|Biological|VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)|The vaccine is composed of the HA stem domain from A/Jiangxi/IPB13/2013 (H10N8) influenza genetically fused to the ferritin protein from H. pylori. Purified H10ssF-6473 displays eight well-formed HA trimers that antigenically resemble the native H10 stem viral spikes.
16396648|NCT04575857|Drug|Atorvastatin|Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.
16396649|NCT04575857|Drug|Placebo|Participants in the control arm will receive a pill packet with placebo x 18 months.
16396650|NCT04572581|Other|Donor Breast Milk|Donor breast milk will be given to the newborn if supplementation is required
16396651|NCT04571216|Drug|NFL-101 dose 1|Subcutaneous injections
16396652|NCT04571216|Drug|NFL-101 dose 2|Subcutaneous injections
16396653|NCT04571216|Drug|Placebo|Subcutaneous injections
16396729|NCT04491877|Biological|RSV vaccine formulation 1|Pharmaceutical form: Suspension of virus Route of administration: Intranasal
16396659|NCT04564261|Behavioral|Personalized Healthy Relationship and Safety Planning Tool|"The app delivers evidence-based information and resources in three sections:
~My Relationship: contains a series of activities (e.g., quizzes) to raise awareness of common myths about unhealthy relationships, determine characteristics of healthy relationships, examine the red flags in an unhealthy relationship, and assess risk factors for more severe abuse. Participants are provided with personalized messages about their relationship health and safety based on the answers they endorse.
~My Strategies: personalized strategies to increase participants' safety and well-being based on responses in the previous section.
~My Resources: direct links to the National Dating Abuse hotline, textline, and chatline, as well as personalized health and safety resources."
16396660|NCT04564261|Behavioral|Usual Care Teen Relationship and Health Website|The control group website will provide participants with tools to learn about health topics including examining healthy relationships. The resources will be targeted to adolescents. The control group website is not personalized to the participant or their relationship.
16396661|NCT04563481|Other|Hand Therapy via Telerehabilitation|"stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
~3 days / week with physiotherapist
~2 days / week as home program 30 minutes / day 12 repetitions"
16396662|NCT04563481|Other|Hand Therapy by Physiotherapist|"stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
~3 days / week with physiotherapist
~2 days / week as home program 30 minutes / day 12 repetitions"
16396663|NCT04562324|Drug|SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics|Medications to relieve anxiety
16396664|NCT04562324|Device|Neurofeedback system|EEG-neurofeedback is an operant conditioning procedure in which people learn to improve the brain's functional activity and used as a way to effect long-term change in abnormal brain activity thus alter corresponding cognitive function. In addition, its potential to be used to elucidate the mechanisms underlying psychopathology by evaluating the subjective effect of the modulation of specific brain areas has become apparent. Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks
16396665|NCT04562298|Biological|LCAR-M23 cells|Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen.
16396668|NCT04560504|Other|Control Group|Leisure activities
16396669|NCT04560504|Other|Oculomotor Training Group|Eye movement training
16396670|NCT04558151|Behavioral|preoperative inspiratory muscle training|Physiotherapists will measure the maximal inspiration pressure (MIP) with the POWER®breathe device of each single patient. Patients will then be instructed to perform inspiratory muscle training at the level of 60% of their individual MIP. Patients are instructed to perform the training containing of 30 breaths twice a day for 14-18 days before surgery. The devices are able to register the performance of each single training session and training results are monitored.
16396671|NCT04556838|Drug|VVN001 Ophthalmic Solution 1%|VVN001 Ophthalmic Solution 1%
16396672|NCT04556838|Drug|VVN001 Ophthalmic Solution 5%|VVN001 Ophthalmic Solution 5%
16396673|NCT04556838|Drug|Vehicle|VVN001 Ophthalmic Solution Vehicle
16396674|NCT04556682|Device|Rotational atherectomy|Device used for severely calcified coronary lesion preparation before stent implantation.
16396675|NCT04556682|Device|Intravascular lithotripsy|Device used for severely calcified coronary lesion preparation before stent implantation.
16396676|NCT04552912|Behavioral|Build Stamina Program|Build StaMINA intervention is a self-management intervention that provides information, motivation, behavioral skills to engage in PA, and ultimately a tailored PA program for adults with AL who are receiving consolidation/maintenance chemotherapy.
16396677|NCT04550780|Drug|Mepolizumab|The first administration of mepolizumab.
16396680|NCT04546633|Drug|KAF156|Provided as 50 mg or 100 mg tablets, to be taken QD 2 Days in combination with LUM-SDF, dose is based on body weight
16396681|NCT04546633|Drug|LUM-SDF|Provided as 60 mg, 120 mg or 240 mg powder in sachet, to be taken QD 2 Days in combination with KAF156, dose is based on body weight
16396682|NCT04545385|Drug|TEV-48574|subcutaneous injection
16396683|NCT04545385|Drug|Placebo|Matching Placebo
16396684|NCT04542148|Drug|Sliding Scale Insulin|After antenatal corticosteroid administration, women will continue to receive long- and short-acting subcutaneous insulin injections as prescribed at home. In addition, they will receive supplemental short-acting insulin using a sliding scale based on postprandial glucose values. Capillary blood glucose values will be measured with fingersticks 4 times daily (fasting and 1-hour postprandial).
16396685|NCT04542148|Drug|Up-Titration of Home Insulin|After antenatal corticosteroid administration, women will receive long- and short-acting subcutaneous insulin injections at increased dosages compared to that prescribed at home. Insulin will be increased by 30% on the day that they receive their 1st dose of antenatal corticosteroids (day 1), 50% on day 2, 50% on day 3, 30% on day 4, and 15% increase on day 5. On day 6 they will return to their home insulin regimen. Capillary blood glucose values will be measured with fingersticks 4 times daily (fasting and 1-hour postprandial).
16396726|NCT04493645|Behavioral|Foot Intensive Rehabilitation (FIRE)|6 weeks of FIRE will be given along with elements of SOC. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.
16396686|NCT04542148|Drug|Continuous Insulin Infusion|After antenatal corticosteroid administration, women will discontinue their home insulin regimen and be placed on a continuous insulin infusion with insulin boluses and titration of infusion rate per institutional L&D protocol. Capillary blood glucose values will be measured with fingersticks every hour.
16396687|NCT04542148|Device|Dexcom G6 Professional Continuous Glucose Monitor|Masked Dexcom G6 Pro devices will be worn for 10 days or until hospital discharge.
16396688|NCT04538482|Behavioral|DASH Diet|Participant will receive foods following the DASH dietary pattern for 28 days.
16396689|NCT04538482|Behavioral|standard American diet|Participants will receive foods following the standard American diet for 28 days.
16396690|NCT04537923|Drug|Tirzepatide|Administered SC
16396691|NCT04537923|Drug|Insulin Lispro (U100)|Administered SC
16396692|NCT04537923|Drug|Insulin Glargine (U100)|Administered SC
16396693|NCT04537884|Drug|UBX1325|Investigational drug intravitreal injection
16396696|NCT04534114|Drug|BAY2976217|Study intervention will be injected subcutaneously.
16396697|NCT04534114|Drug|Placebo|Matching placebo to BAY2976217 will be injected subcutaneously.
16396698|NCT04530747|Drug|Metformin|Subjects randomized to this arm will receive 500 mg capsules containing metformin XR. Metformin XR dosing will be 500 mg (1 x 500 mg) qPM during Week 1, 1000 mg (2 x 500 mg) qPM during Week 2, 1500 mg (3 x 500 mg) qPM during Week 3, and 2000 mg (4 x 500 mg) qPM from Week 4 onwards.
16396699|NCT04530747|Drug|Placebo oral capsule|Subjects randomized to this arm will receive 500 mg capsules containing placebo. Placebo dosing will be 500 mg (1 x 500 mg) qPM during Week 1, 1000 mg (2 x 500 mg) qPM during Week 2, 1500 mg (3 x 500 mg) qPM during Week 3, and 2000 mg (4 x 500 mg) qPM from Week 4 onwards.
16396700|NCT04530110|Drug|Fremanezumab|"Participants weighing ≥ threshold will receive Dose A subcutaneously monthly.
~Participants weighing < threshold will receive Dose B subcutaneously monthly.
~Subcutaneously monthly, confirmed or adjusted, as appropriate, based on the participant's weight every 3 months."
16396701|NCT04527614|Diagnostic Test|qRT-PCR and serology|qRT-PCR and serology
16396702|NCT04526366|Device|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.
16396703|NCT04526366|Device|Polysomnography|Polysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.
16396704|NCT04525547|Drug|Nintedanib|Nintedanib
16396708|NCT04513314|Drug|Valproate|Valproate sodium (enteral or intravenous) will be administered at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day.
16396709|NCT04513314|Drug|Quetiapine|Enteral quetiapine dosing on Day 3: 25 mg to 50 mg twice daily. Increase in increments of 50 mg/day to 100 mg/day divided two on Days 4 and 5 to range of 50-400 mg/day by Day 7. Further adjustments can be made in increments of 25-50 mg twice a day, in intervals of not less than 2 days. Recommended dose range is 150-750 mg/day.
16396710|NCT04513314|Other|Standard of Care|Standard of Care is a combination of IV dexmedetomidine (D), midazolam (M), ketamine (K) and propofol (P), at the discretion of treating physician.
16396713|NCT04509674|Drug|Empagliflozin|Empagliflozin
16396714|NCT04509674|Drug|Placebo|Placebo
16396717|NCT04506190|Procedure|Revisional bariatric surgery|Subjects who undergo revisional bariatric surgery
16396718|NCT04504383|Drug|PN-943|Administered by the oral route BID for the duration of the study.
16396719|NCT04504383|Drug|Placebo|Administered by the oral route BID for 12 weeks.
16396720|NCT04502706|Drug|GS-0189|GS-0189 will be administered intravenously.
16396721|NCT04502706|Drug|Rituximab|Rituximab will be administered intravenously.
16396722|NCT04497584|Drug|Afatinib + Prednisone|Afatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1.
16396723|NCT04497493|Device|Transcranial Direct Current Stimulation (tDCS)-active|Transcranial direct current stimulation (TDC) is a non-invasive neuromodulation technique of the brain with a DC microelectrical stimulator, a cathode electrode and an anode electrode, and a control software to set the output of the stimulation type，participants receive 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks
16396724|NCT04497493|Device|Transcranial Direct Current Stimulation (tDCS)-sham|Transcranial direct current stimulation (TDC) is a non-invasive neuromodulation technique of the brain with a DC microelectrical stimulator, a cathode electrode and an anode electrode, and a control software to set the output of the stimulation type. Participants receive sham stimulation over the dorsolateral prefrontal cortex, with current turned off after 30 second. The session last 20 min 5 days per week, for 4 weeks
16396725|NCT04493645|Behavioral|Standard of Care Rehabilitation (SOC)|6 weeks of standard of care rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.
16396727|NCT04493424|Drug|Spesolimab|Spesolimab
16396728|NCT04492384|Other|non-interventional|Interview on health conditions
16396730|NCT04491877|Biological|RSV vaccine formulation 2|Pharmaceutical form: Suspension of virus Route of administration: Intranasal
16396731|NCT04491877|Biological|Placebo|Pharmaceutical form: Suspension Route of administration: Intranasal
16396732|NCT04487847|Diagnostic Test|18F-PSMA-1007 PET/CT|18F-PSMA-1007 PET/CT
16396734|NCT04483726|Procedure|minimally invasive distal pancreatectomy|Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
16396735|NCT04483726|Procedure|open distal pancreatectomy|open distal pancreatectomy
16396736|NCT04482725|Other|Trial product 1|Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
16396737|NCT04482725|Other|Trial product 2|Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
16396738|NCT04482725|Other|Trial product 3|Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
16396739|NCT04482725|Other|Trial product 4|Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
16396740|NCT04482725|Other|Trial product 5|Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
16396741|NCT04482725|Other|Trial product 6|Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
16396742|NCT04482725|Other|Trial product 7|Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
16396743|NCT04482725|Other|Trial product 8|Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
16396744|NCT04482725|Other|Trial product 9|Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
16396745|NCT04482725|Other|Trial product 10|Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
16396746|NCT04482725|Other|Trial product 10|Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
16396747|NCT04482725|Other|Trial product 12|Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
16396748|NCT04469075|Drug|Clindamycin Phosphate|phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
16396749|NCT04469075|Drug|Triamcinolone Acetonide|triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change
16396750|NCT04458831|Drug|isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16396751|NCT04458831|Drug|Pomalidomide|Pharmaceutical form: oral
16396752|NCT04458831|Drug|Dexamethasone|Pharmaceutical form: oral
16396753|NCT04458831|Drug|Carfilzomib|Pharmaceutical form: solution for infusion
16396754|NCT04455750|Drug|Enzalutamide|Given PO
16396755|NCT04455750|Drug|Rucaparib camsylate|Given PO
16396756|NCT04455750|Drug|Placebo|Given PO
16396757|NCT04455750|Drug|Leuprolide Acetate|Given IM
16396758|NCT04455750|Drug|Goserelin Acetate|Given SC
16396759|NCT04455750|Drug|Degarelix|Given SC
16396760|NCT04455750|Other|Quality-of-Life Assessment|Ancillary studies
16396761|NCT04455750|Other|Questionnaire Administration|Ancillary studies
16396762|NCT04452955|Biological|PRL3-zumab|Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)
16396763|NCT04451161|Behavioral|Beliefs and Attitudes for Successful Implementation in Schools (BASIS)|BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.
16396764|NCT04451161|Behavioral|Trauma-Focused Cognitive-Behavioral Therapy|TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.
16396765|NCT04451161|Behavioral|Treatment as Usual|Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
16396766|NCT04451161|Behavioral|Attention Control|Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform
16396767|NCT04450732|Drug|GQ1001|anti-HER2 antibody drug conjugate
16396768|NCT04447118|Drug|Pyrotinib|400 mg, once daily (QD), will be administered with water within 30 minutes after completion of a meal, at approximately the same time each day on a continuous daily dosing schedule, with 21 days as a cycle.
16396769|NCT04447118|Drug|Docetaxel|75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
16396770|NCT04443062|Drug|177Lu-PSMA-617|PSMA radioligand therapy
16396771|NCT04441775|Other|AI-assisted RT modelling|Artificial Intelligence assisted Radiation Treatment
16396772|NCT04440176|Biological|MenABCWY|Neisseria meningitidis group A, B, C, W, and Y vaccine
16396773|NCT04440176|Biological|Saline|Placebo
16396774|NCT04439071|Drug|PTC299|Oral tablets
16396775|NCT04439071|Other|SOC|As defined per local written policies or guidelines.
16396776|NCT04439071|Drug|Placebo|Oral tablets
16396779|NCT04433585|Drug|LY3471851|Administered SC
16396780|NCT04433585|Drug|Placebo|Administered SC
16396781|NCT04431453|Drug|Remdesivir|Administered as an intravenous infusion
16396782|NCT04427488|Other|Morning Chronotype group|Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
16396783|NCT04427488|Other|Evening Chronotype group|Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
16396786|NCT04420221|Biological|Sa-5Ag half dose non-adjuvanted|1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
16396787|NCT04420221|Biological|Sa-5Ag full dose non-adjuvanted|1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
16396788|NCT04420221|Biological|Sa-5Ag half dose adjuvanted|1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
16396789|NCT04420221|Biological|Sa-5Ag full dose adjuvanted|A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
16396790|NCT04420221|Drug|Placebo|One dose of placebo (saline) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
16396791|NCT04420208|Procedure|Modified Pap test|Adding a non-painful step after the most uncomfortable phase of Pap smear
16396792|NCT04409002|Drug|Niraparib|Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
16396793|NCT04409002|Drug|Dostarlimab|Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
16396794|NCT04409002|Radiation|Radiation|Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
16396797|NCT04406415|Drug|Nafamostat Mesilate|Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days
16396798|NCT04406415|Drug|Placebo|Oral placebo administered three times daily for up to 5 days
16396803|NCT04402996|Other|Saliva|"individuals' saliva samples will be collected and transferred to eppendorf tubes.
~Until biochemical analysis is carried out will be stored in -80ºC."
16396804|NCT04402996|Other|gingival crevicular fluid|"GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.
~Until biochemical analysis is carried out will be stored in -80ºC."
16396807|NCT04402489|Drug|Placebo|Placebo
16396808|NCT04402489|Drug|MT-7117 Low Dose|MT-7117 Low Dose
16396809|NCT04402489|Drug|MT-7117 High Dose|MT-7117 High Dose
16396810|NCT04401280|Drug|BiominF|in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
16396811|NCT04401280|Drug|Novamin|in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
16396812|NCT04401280|Drug|CPP-ACP|applied in accordance with the manufacturer's specifications
16396813|NCT04399538|Drug|PF-06865571|Tablet
16396814|NCT04399538|Drug|PF-05221304|Tablet
16396815|NCT04399538|Drug|Placebo|Tablet
16396823|NCT04392154|Biological|Lebrikizumab|Subcutaneous injection
16396824|NCT04390867|Device|TOPS1 DBS|TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
16396825|NCT04390867|Device|TOPS2 DBS|TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
16396826|NCT04390867|Device|TOPS3 DBS|TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
16396827|NCT04390867|Device|Standard DBS|Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
16396828|NCT04390399|Biological|N-803|Recombinant human super agonist interleukin-15 (IL-15) complex
16396829|NCT04390399|Drug|Aldoxorubicin HCl|Aldoxorubicin hydrochloride
16396830|NCT04390399|Biological|PD-L1 t-haNK|PD-L1 t-haNK suspension for infusion
16396831|NCT04390399|Drug|Nab-paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
16396832|NCT04390399|Drug|Gemcitabine|2', 2'-difluoro 2'deoxycytidine, dFdC
16396833|NCT04390399|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
16396834|NCT04390399|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
16396835|NCT04390399|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
16396836|NCT04390399|Procedure|SBRT|Stereotactic Body Radiation Therapy
16396837|NCT04390399|Drug|Irinotecan liposome|Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate
16396842|NCT04385875|Biological|Vaccine + extension of the ATI period|During the AELIX-002 trial participants received the following: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. After that, on ATI_extension trial, ATI will be extended for 48 weeks.
16396843|NCT04385875|Other|Placebo + extension of the ATI period|During the AELIX-002 trial participants received the following: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. After that, on ATI_extension trial, ATI will be extended for 48 weeks.
16396844|NCT04385277|Biological|Dinutuximab|Given IV
16396845|NCT04385277|Drug|Irinotecan|Given IV
16396846|NCT04385277|Drug|Isotretinoin|Given PO
16396847|NCT04385277|Biological|Sargramostim|Given SC or IV
16396848|NCT04385277|Drug|Temozolomide|Given PO or via enteral tube
16396849|NCT04384770|Radiation|CT-guided Stereotactic Body Radiation Therapy|Undergo CT-guided SBRT
16396850|NCT04384770|Radiation|MRI-guided Stereotactic Body Radiation Therapy|Undergo MRI-guided SBRT
16396851|NCT04384770|Other|Questionnaire Administration|Ancillary studies
16396856|NCT04384029|Other|Covid-19 + patients|all the patients hospitalized in Geneva and SARS-Cov2 positive
16396857|NCT04378790|Other|Patching|Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
16396858|NCT04378790|Other|Glasses|Eye Glasses are created and worn by patient to improve vision
16396859|NCT04378751|Behavioral|Decision aid video|Decision aid video
16396860|NCT04378751|Behavioral|Genetic counseling informational brochure|Genetic counseling informational brochure
16396867|NCT04370613|Behavioral|Prospective Imagery visualization task|Participant visualizes brief mental imagery of prospective situations of different valence (neutral, positive, negative).
16396868|NCT04368936|Genetic|Isolated DNA, Real Time PCR|"We are isolated DNA from the blood sample. To determine the genotypes of the analyzed polymorphisms use real-time PCR using TaqMan essays.
~When analyzing the KCC2 polymorphisms, the VIC dye gene corresponded to the C allele, and the FAM dye corresponded to the T allele, while at the TRPV1 gene polymorphism, the VIC dye corresponded to the C allele and the FAM dye to the G allele."
16396869|NCT04355767|Biological|Convalescent Plasma|SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
16396870|NCT04355767|Biological|Saline|Saline with multivitamin administered via intravenous (IV) infusion..
16396871|NCT04353037|Drug|Group 1 HCQ|Enrolled participants randomized in Group 1 receive the HCQ drug
16396872|NCT04353037|Drug|Group 2 Placebo|Enrolled participants randomized in Group 2 will receive a placebo drug
16396873|NCT04351685|Biological|VPM1002|"The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally.
~Manufactured by the Serum Institute of India Pvt. Ltd., India
~Diluent: 1 ml of Water for injection/vial"
16396874|NCT04351685|Biological|BCG SII|"Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally.
~Manufactured by the Serum Institute of India Pvt. Ltd., India
~Diluent: 1 ml of Sodium Chloride for injection/vial Injection"
16396875|NCT04340895|Other|Faecal Calprotectin Home Test|"A non-invasive, in vitro diagnostic test for the determination of FC levels in human stool samples in combination with the dedicated 'CalproSmart' smartphone application.
~This test helps participants to self-monitor their FC levels at their own homes, ensuring an adequate and effective medical treatment regimen performed by the investigator."
16396876|NCT04340895|Other|PRO-2 Scoring|Monitoring of clinical symptoms will be performed by PRO-2 scoring, which includes rectal bleeding (RB) and stool frequency (SF) assessment obtained within the last 3-days.
16396878|NCT04335799|Behavioral|Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training|12-month evidence based weight loss intervention with additional training on stress management strategies
16396879|NCT04335799|Behavioral|Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics|12-month evidence based weight loss intervention with an attention control of general women's health topics
16396882|NCT04331769|Device|AccuCinch Ventricular Restoration System|AccuCinch Ventricular Restoration System
16396883|NCT04331769|Drug|Guideline-Directed Medical Therapy|Guideline-Directed Medical Therapy
16396884|NCT04331080|Drug|Granexin® gel 100 μM|Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
16396885|NCT04331080|Drug|Granexin® gel 200 μM|Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
16396886|NCT04331080|Drug|Vehicle gel|Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
16396887|NCT04324359|Drug|SURF-201|One drop twice daily (BID) in the study eye for 16 days.
16396888|NCT04324359|Drug|Placebo|One drop twice daily (BID) in the study eye for 16 days.
16396889|NCT04323852|Drug|Vitamin D|Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery
16396890|NCT04323852|Drug|Placebo|Placebo
16396897|NCT04309474|Drug|Elezanumab|Intravenous (IV) infusion
16396898|NCT04309474|Drug|Placebo|Intravenous (IV) infusion
16396899|NCT04303689|Drug|Colchicine Tablets|patients with essential hypertension are randomized to receive either 3 weeks of colchicine
16396900|NCT04303689|Drug|Placebo|patients with essential hypertension are randomized to receive either 3 weeks of placebo-treatment
16396901|NCT04293562|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSCT
16396902|NCT04293562|Drug|Asparaginase|Given IM or IV
16396903|NCT04293562|Drug|Asparaginase Erwinia chrysanthemi|Given IM or IV
16396904|NCT04293562|Behavioral|Cogstate Assessment Battery|Ancillary studies
16396905|NCT04293562|Drug|Cytarabine|Given IV or IT
16396906|NCT04293562|Drug|Daunorubicin Hydrochloride|Given IV
16396907|NCT04293562|Drug|Dexrazoxane Hydrochloride|Given IV
16396908|NCT04293562|Drug|Etoposide|Given IV
16396909|NCT04293562|Drug|Gemtuzumab Ozogamicin|Given IV
16396910|NCT04293562|Drug|Gilteritinib Fumarate|Given PO or via NG or G tube
16396911|NCT04293562|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
16396912|NCT04293562|Drug|Methotrexate|Given IT
16396913|NCT04293562|Drug|Mitoxantrone Hydrochloride|Given IV
16396914|NCT04293562|Drug|Therapeutic Hydrocortisone|Given IT
16396915|NCT04292275|Device|Biobeat Wrist Watch|Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.
16396916|NCT04292275|Other|Standard of Care|Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.
16396917|NCT04286789|Drug|Low dose ORTD-1|Once weekly, single subcutaneous injection of ORTD-1 at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
16396918|NCT04286789|Drug|Low dose vehicle control|Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
16396919|NCT04286789|Drug|High dose ORTD-1|Two subcutaneous injections of ORTD-1 at two injection sites once weekly; 0.90 mL of ORTD-1 per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.
16396920|NCT04286789|Drug|High dose vehicle control|Two subcutaneous injections of vehicle at two injection sites once weekly; 0.90 mL of vehicle per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.
16396921|NCT04286191|Combination Product|Operant Conditioning|This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
16396922|NCT04286191|Combination Product|Control Group|This is the control intervention, or the non-conditioning group. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
16396925|NCT04279431|Device|EEG Recording|EEG recording acquired on BrainScope One device.
16396926|NCT04279431|Other|Neurocognitive Tests|Cognitive performance tests performed on BrainScope One device.
16396927|NCT04279431|Other|Clinician Evaluation|Clinician evaluation performed as part of standard of care at the clinical site.
16396928|NCT04279431|Other|22-item CSI|Self assessed 22-item Concussion Symptom Inventory (CSI).
16396929|NCT04277975|Other|Liberal post-discharge opioid prescribing|Opioid prescribed all patients opioids 'in case they are needed' prior to surgery
16396930|NCT04277975|Other|Restricted post-discharge opioid prescribing|Opioid only if needed after discharge
16396931|NCT04276415|Drug|DS-6157a|Administered as a single agent intravenously (IV) every 3 weeks
16396932|NCT04275531|Drug|Anesthesia Agent|various anesthetic agents used in both general and regional anesthesia
16396933|NCT04273386|Other|Evaluation|The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.
16396943|NCT04262479|Drug|recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel|3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden
16396944|NCT04262479|Drug|Vitamin D|1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
16396947|NCT04257279|Procedure|ExcelsiusGPS™|The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera.
16396948|NCT04255433|Drug|Tirzepatide|Administered SC
16396949|NCT04255433|Drug|Dulaglutide|Administered SC
16396952|NCT04253327|Other|questionnaire|"Patients will be contacted by their physician during regular follow-up in the out-patient clinic or contacted by phone.
~The questionnaires will be filled in at the UZBrussel, Laarbeeklaan 101, 1090 Brussels or at the patients home.
~Filled-in questionnaires can be hand off immediately at the physician or send by post or email.."
16396953|NCT04249401|Drug|Rivaroxaban (Xarelto)|NOAC, reduced dose
16396954|NCT04249401|Drug|Apixaban|NOAC, reduced dose
16396955|NCT04249401|Drug|Dabigatran|NOAC, reduced dose
16396956|NCT04249401|Drug|Warfarin|VKA
16396957|NCT04248829|Drug|Lazertinib 240 mg/160 mg|The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances
16396958|NCT04248829|Drug|Gefitinib 250 mg|The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
16396959|NCT04248829|Drug|Lazertinib-matching placebo 240 mg/160 mg|The initial dose of lazertinib-matching placebo 240 mg (3 tablets of 80 mg lazertinib-matching placebo) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib-matching placebo) under specific circumstances
16396960|NCT04248829|Drug|Gefitinib-matching placebo 250 mg|The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose
16396961|NCT04246528|Behavioral|SPIN-SELF Program|The SPIN-SELF program utilizes social modelling through educational videos of scleroderma patients who describe their own challenges and what they have done to cope with living with scleroderma, as well as videos of patients and health professionals who teach key self-management techniques. The program includes sections on general self-management skills, including goal-setting and self-monitoring), progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with using self-management techniques to cope with SSc symptoms. The program's 9 modules focus on (1) coping with pain; (2) skin care, finger ulcers and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) managing emotions and stress; (8) coping with body image concerns due to disfigurement; and (9) effective communication with healthcare providers.
16396962|NCT04245228|Behavioral|Wellness Coach|Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
16396963|NCT04239716|Other|regional anesthesia|combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection
16396964|NCT04236856|Device|Robotic Endovascular Procedure|After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
16396966|NCT04232761|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Drug administration as determined by treating physician
16396967|NCT04232371|Procedure|New Ablation Technique|Patient will undergo ablation using voltage mapping and triangle of Koch propagation wave collision mapping. Ablation will be performed at or slightly above the site of wave front collision.
16396968|NCT04232371|Procedure|Standard Ablation Technique|Ablation performed using the traditional anatomical / electrogram guided ablation approach.
16396969|NCT04228367|Device|JuggerStitch Meniscal Repair Device|Treatment of torn meniscus with JuggerStitch.
16396970|NCT04223856|Drug|Enfortumab vedotin|Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
16396971|NCT04223856|Drug|Pembrolizumab|IV infusion on Day 1 of every 3-week cycle
16396972|NCT04223856|Drug|Cisplatin|administered as IV infusion on Day 1 of each 3-week cycle
16396973|NCT04223856|Drug|Carboplatin|Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
16396974|NCT04223856|Drug|Gemcitabine|IV infusion on Days 1 and 8 of every 3 week cycle
16396975|NCT04216329|Drug|Selinexor|Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation.
16396976|NCT04216329|Drug|Temozolomide|Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-RT, the adjuvant temozolomide will be given per standard of care.
16396977|NCT04216329|Radiation|Generic Radiation therapy (RT)|Radiation therapy (RT) will be administered daily (Monday to Friday)
16396978|NCT04215848|Drug|Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder|After the patients who have all criteria, they will be randomized to take Budesonide/formoterol (160/4.5 μg/d) as need when they have symptoms.
16396979|NCT04215848|Drug|Budesonide 200Mcg Inhalation Powder|After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily
16396989|NCT04211337|Drug|Selpercatinib|Administered orally
16396990|NCT04211337|Drug|Cabozantinib|Administered orally
16396991|NCT04211337|Drug|Vandetanib|Administered orally
16396992|NCT04208230|Device|XtremeCT|HRpQCT technology provides information on bone microarchitecture, bone density and bone strength by measuring the cortical and trabecular bone structures with improved spatial resolution and defining the surfaces in three-dimensional manner.
16396995|NCT04200534|Other|Best Practice|Receive usual care counseling
16396996|NCT04200534|Drug|Nicotine Patch|Given nicotine patches
16396997|NCT04200534|Other|Quality-of-Life Assessment|Ancillary studies
16396998|NCT04200534|Other|Questionnaire Administration|Ancillary studies
16396999|NCT04200534|Other|Tobacco Cessation Counseling|Receive counseling over the phone
16397000|NCT04200352|Drug|TEV-50717|Oral tablets are 6, 9, and 12 mg.
16397001|NCT04198558|Drug|MEDI0618|MEDI0618 A novel human immunoglobulin antibody
16397002|NCT04198558|Drug|Placebo|Placebo
16397005|NCT04195399|Drug|Nirogacestat|Given PO
16397006|NCT04195399|Other|Quality-of-Life Assessment|Ancillary studies
16397007|NCT04195399|Other|Questionnaire Administration|Ancillary studies
16397008|NCT04194944|Drug|Selpercatinib|Administered orally
16397009|NCT04194944|Drug|Carboplatin|Administered IV
16397010|NCT04194944|Drug|Cisplatin|Administered IV
16397011|NCT04194944|Drug|Pemetrexed|Administered IV
16397012|NCT04194944|Drug|Pembrolizumab|Administered IV
16397013|NCT04191928|Drug|Apixaban|Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
16397014|NCT04186650|Biological|COL7A1-SIN retroviral vector engineered autologous tissue-engineered skin|Graft of SIN RV-mediated COL7A1 gene-modified autologous skin equivalent
16397018|NCT04178720|Device|Lehfilcon A contact lenses|Investigational silicone hydrogel contact lenses
16397019|NCT04178720|Device|Comfilcon A contact lenses|Commercially available silicone hydrogel contact lenses
16397020|NCT04178720|Device|CLEAR CARE|Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
16397021|NCT04175184|Other|Mobilisation with Movement|"MWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results.
~The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion."
16397022|NCT04175184|Other|Sham Mobilisation with Movement|Sham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms.
16397023|NCT04174651|Behavioral|Trier Social Stress Test (TSST)|Participants randomized to receive the acute stress condition will undergo the TSST wherein the participant will be introduced to an upcoming task (i.e., job interview) and allowed to prepare (2 minutes). The participant will then be required to speak (job interview) for 4 minutes in front of 2 experimenters. After completion of the interview, participants will be asked to perform a mental arithmetic task for 4 minutes.
16397024|NCT04174651|Behavioral|Landscape Video|Participants randomized to receive the control condition will be watching a landscape video for 10 minutes.
16397025|NCT04166773|Drug|Tirzepatide|Administered SC
16397026|NCT04166773|Drug|Placebo|Administered SC
16397032|NCT04161885|Drug|Venetoclax|Tablet; Oral
16397033|NCT04161885|Drug|Azacitidine|Subcutaneous (SC) or intravenous (IV) injection
16397034|NCT04161885|Other|Best Supportive Care (BSC)|BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
16397037|NCT04128423|Biological|AMV564|AMV564 will be administered daily
16397038|NCT04126031|Drug|Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3|Single intravenous infusion of ceftazidime-avibactam over 2 hours
16397039|NCT04126031|Drug|Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3|Multiple intravenous infusions of ceftazidime-avibactam over 2 hours, repeated every 8 hours up to 14 days
16397040|NCT04113382|Drug|CLENPIQ|"CLENPIQ consists of sodium picosulfate 10.0 mg + magnesium oxide 3.5 g + citric acid, anhydrous 12.0 g.
~Supplied as a pre-mixed, ready-to-drink oral solution in two bottles, each containing 160 mL."
16397041|NCT04113382|Drug|MIRALAX|MIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol [PEG] 3350).
16397042|NCT04109521|Other|Training, certification and marketing|The 12hr training will address the vendors (i) knowledge on hygienic handling of milk, preservation and low-cost methods for testing milk safety; (ii) business skills in record keeping, access and management of credit; (iii) milk marketing. On completion of the training and successfully passing an evaluation, vendors will be given a written certificate using a format suitable to be displayed in their premises (i.e. A4 poster, a hat or badge) indicating they have completed the training. The certification will not have legal value. Two quarterly unannounced visits will be conducted to collect a milk sample from the vendors and report back the results of microbiological quality. Vendors will have access to various milk marketing and communication items to be used in their daily operations. The materials will promote milk consumption through marketing focused on messages to consumers related to (i) good milk hygiene practices, (ii) good child nutrition practices, and (iii) household diets
16397043|NCT04109079|Procedure|Axillary lymph node dissection|Participants will undergo removal of at least level I and II axillary lymph nodes.
16397044|NCT04109079|Radiation|Axillary radiotherapy|Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
16397045|NCT04109079|Radiation|Breast or chest wall radiotherapy|Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
16397046|NCT04108052|Radiation|Low CT scanner without injection dose|CT scan acquisition will be performed at 140 kVp (kilovolt peak), 10 mAs(milliampere), CTDI 1.3 mGy with an irradiation dose 0.51 mSv (milliSievert). The CT image will be reconstructed and analyzed in parenchyma window. The CT images will be blinded and re-read by two independent senior radiologists 3 to 6 weeks apart between each re-reading.
16397047|NCT04108052|Radiation|Ultra-low dose CT scanner without injection|CT acquisition will be performed at 80 kVp for patient with a body mass index<30, and 100 kVp with a body mass index>30, 10 mAs, CTDI 0.3 and 0.6 mGy with an irradiation dose 0.15-0.30 mSv. The CT images will be reconstructed and analyzed in mediastinal window. The CT images will be blinded and re-read by two independent senior radiologists 3 to 6 weeks apart between each re-reading.
16397048|NCT04107051|Drug|Nalmefene Hydrochloride Hydrate|Oral administration of nalmefene hydrochloride hydrate
16397049|NCT04106167|Genetic|Allogeneic natural killer (NK) cell|No study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell in a previous trial will be evaluated in this trial for long-term safety and efficacy
16397050|NCT04099004|Other|Neural Imaging|During the acquisition of magnetic resonance (MR) images, the study participants will lie on the scanner table. For most portions of MR acquisition, the study participants will be instructed to lie still. For other parts of the acquisition, study participants will be asked to complete a combined knee and hip flexion/extension movement and a quadriceps contraction task in which they will be asked to 'squeeze' their quadriceps while keeping the rest of their body still. For the last 15 minutes of MR acquisition, the researcher will place one hand above the participants' knee and apply intermittent pressure to their quadriceps and medial aspect of the patella. Pain scales will be administered after every fMRI task to assess subjective perceptions of pain. Peripheral pulse oximetry and respiration waveforms will be collected for data analysis in order to minimize the potential confounding effect from the physiological changes.
16397051|NCT04095793|Drug|ampreloxetine|Oral tablet, QD
16397052|NCT04093076|Drug|INO-4500|INO-4500 will be administered ID on Day 0 and Week 4.
16397053|NCT04093076|Device|CELLECTRA™ 2000|EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
16397054|NCT04093076|Drug|Placebo|Placebo will be administered ID on Day 0 and Week 4.
16397055|NCT04092686|Drug|SEP-363856 75mg|SEP-363856 75mg tablet dosed once daily
16397056|NCT04092686|Drug|SEP-363856 100mg|SEP-363856 100mg tablet dosed once daily
16397057|NCT04092686|Drug|Placebo|Placebo tablet dosed once daily
16397064|NCT04092192|Device|IVC filter removal|"In the clinic, it will be explained to patient that they are asked to participate in a study that would randomize them to one of two established techniques for IVC filter removal. It will be explained these are both techniques that are used by interventional radiologists normally used for IVC filter retrieval.
~One technique would be the utilization of an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.
~The other technique described will be the usage of a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed."
16397065|NCT04090710|Drug|Ipilimumab/ Nivolumab|induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression
16397066|NCT04090710|Radiation|SBRT + Ipilimumab/Nivolumab|SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks.
16397071|NCT04089358|Other|Educational Intervention|Receive educational materials
16397072|NCT04089358|Device|FitBit|Wear a Fitbit
16397073|NCT04089358|Other|Goal Setting|Set goals
16397074|NCT04089358|Other|Health Promotion and Education|Receive text message about goal setting
16397075|NCT04089358|Other|Media Intervention|Follow Instagram group
16397076|NCT04089358|Behavioral|Telephone-Based Intervention|Receive phone call about goal setting
16397077|NCT04088591|Drug|Ascorbic Acid 500Mg/Ml Inj|Ascorbic acid 200mg/kg/day administered upon suspicion or confirmation of sepsis every 6 hours for a total duration of 96 hours
16397078|NCT04088591|Drug|Dextrose in Water|50 ml of 5% dextrose in water every 6 hours for a total duration of 96 hours
16397083|NCT04084678|Drug|Ralinepag|Oral ralinepag
16397084|NCT04084678|Drug|Placebo|Matching oral tablets
16397085|NCT04080245|Biological|Treatment Group Live Attenuated Flu Vaccine (LAIV)|We will administer LAIV once as a vaccine prime and IIV once as a vaccine boost with serial weekly blood draws for a month to validate a biomarker of LAIV efficacy.
16397086|NCT04074486|Device|BrainScope Ahead 300iP-O|BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.
16397087|NCT04074486|Diagnostic Test|SCAT5|Sports Concussion Assessment Tool 5
16397088|NCT04074486|Diagnostic Test|Near Point Convergence|Manual ocular function measurement conducted only if electronic version on device fails
16397091|NCT04069624|Behavioral|MOUD Pre-Treatment Telehealth|Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth
16397092|NCT04069624|Behavioral|MOUD Pre-Treatment Telehealth and Peer Navigator|Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth. Additionally, participants will be connected with a Peer Navigator who will meet with them via telehealth prior to release and provide ongoing support by telephone post-release.
16397093|NCT04069624|Other|Services as Usual|Medications to treat opioid use disorder (MOUD) pre-treatment.
16397094|NCT04065048|Other|Soy based diet|The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
16397095|NCT04065048|Other|Non-soy based diet|Diet of identical composition to the soy diet with the exception of soy.
16397099|NCT04051463|Drug|Netarsudil Ophthalmic Solution|Netarsudil eye drops instilled once daily
16397100|NCT04051463|Drug|Placebo|Placebo eye drops instilled once daily
16397101|NCT04047420|Drug|TAF/EVG Insert|TAF/EVG Insert (20/16 mg) administered rectally by study staff
16397102|NCT04045028|Drug|Tiragolumab|Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)
16397103|NCT04045028|Drug|Daratumumab/rHuPH20|Administered by SC injection 1800 mg/30,000 U rHuPH20 weekly for a total of 6 doses, then every 3 weeks for a total of 16 doses (first dose given at Week 7), then every 4 weeks from Week 55 onward until disease progression
16397104|NCT04045028|Drug|Rituximab|Administered for a total of 8 doses. Rituximab will be administered by IV infusion for the first dose at a dose of 375 mg/m^2. After administration of at least one full infusion of IV rituximab, the SC formulation of rituximab (rituximab and rHuPH20) may be used for the remaining doses per institutional guidelines. SC rituximab will be administered at a dose of 1400 mg rituximab/23400 U rHuPH20 once weekly (QW).
16397105|NCT04045028|Drug|Atezolizumab|Administered by IV infusion at a fixed dose of 1200 mg Q3W
16397106|NCT04040634|Drug|Intensive Control of Systolic Blood Pressure (SBP)|Participants in the Intensive arm have a goal of SBP <120 mm Hg. The use of angiotensin converting enzyme (ACE) inhibitors/angiotension receptor blockers (ARB), thiazide-type diuretics, and calcium channel blockers (CCB) will be encouraged.
16397107|NCT04040634|Drug|Standard control of Systolic Blood Pressure (SBP)|The same medications used in the Intensive BP arm will be used for the Standard BP arm.
16397108|NCT04028388|Drug|Docetaxel in Parenteral Dosage Form|Treatment with IV docetaxel at 75 mg/m2 given as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily
16397109|NCT04028388|Drug|ModraDoc006/r|Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
16397110|NCT04025983|Dietary Supplement|GastimunHp Plus|Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
16397111|NCT04025983|Other|Placebo|The placebo contains neither IgY nor L. johnsonii.
16397112|NCT04024670|Other|Arts Intervention|If selected for the arts activity, an artist in residence will visit you 3 times a week for a total of 3 weeks during your hospital stay. Two visits will focus on the arts activity and one visit will be the administration of the questionnaire. Each visit will be approximately 25 minutes at a time.
16397113|NCT04011592|Drug|Ketamine 0.5 mg/kg|single intravenous infusion of Ketamine (0.5 mg/kg)
16397114|NCT04011592|Drug|Ketamine 0.2 mg/kg|single intravenous infusion of Ketamine (0.2 mg/kg)
16397115|NCT04003506|Drug|Liposomal bupivacaine|LIA with ACB will be given using 10ml of 1.33% liposomal bupivacaine
16397116|NCT04003506|Drug|Bupivacaine Injection|LIA with ACB will be given using 15ml 0.25% bupivacaine
16397117|NCT04001075|Drug|TJ107|Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
16397118|NCT03996473|Drug|Radium-223 dichloride (Xofigo, BAY 88-8223)|Intravenous (IV) injection, every 6 weeks for up to 6 administrations
16397119|NCT03996473|Drug|Pembrolizumab|IV infusion, every 3 weeks for a maximum of up to 35 administrations
16397132|NCT03973593|Behavioral|Enhancing contraceptive counseling on method continuation and switching|Health care workers and Community Health Volunteers will be trained on a contraceptive counseling package that enhances information on method continuation and switching. This will be done in the ten intervention facilities prior to enrollment of clients into the cohort study.
16397133|NCT03964207|Drug|Tiotropium Respimat® (T1)|inhalation solution
16397134|NCT03964207|Drug|Tiotropium Handihaler® (T2)|Inhalation Powder
16397135|NCT03962543|Drug|Mirdametinib (PD-0325901) oral capsule or dispersible tablet|Mirdametinib (PD-0325901) capsule or dispersible tablet
16397136|NCT03955640|Drug|Olaparib|Given PO
16397137|NCT03955640|Procedure|Hyperthermia Treatment|Undergo hyperthermia treatment
16397138|NCT03955640|Other|Questionnaire Administration|Ancillary studies
16397139|NCT03955640|Other|Quality-of-Life Assessment|Ancillary studies
16397140|NCT03954782|Drug|Nintedanib 150 mg and 100 mg soft capsules|Nintedanib 150 mg soft capsules twice daily approximately 12 hours apart (i.e. 300 mg/day) for 12 weeks. In case of adverse reaction a dose reduction at 200 mg/day (100 mg twice daily) can be prescribe.
16397141|NCT03954782|Drug|Oral treatment of placebo soft capsule|Placebo soft capsules (identical to 150 mg and 100 mg soft capsules)
16397142|NCT03954002|Diagnostic Test|TTE and TOE|"A small flexible tube (TOE probe) will be inserted into your oesophagus, or food pipe, to take images of your heart as per routine anaesthetic care for cardiac surgery.
~Just before and after general anaesthesia is administered, a short transthoracic echocardiography (TTE scan will be performed to acquire images of your heart. This is an ultrasound scan of your heart using a probe on the outside of the chest. During this period, relevant haemodynamic data such as blood pressure and heart rate will be recorded."
16397149|NCT03952559|Drug|Baricitinib|Administered orally
16397150|NCT03952559|Drug|Placebo|Administered orally
16397151|NCT03952559|Drug|Topical corticosteroid|Administered as standard-of-care
16397152|NCT03952091|Drug|TJ202, Lenalidomide and Dexamethasone|One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
16397153|NCT03952091|Drug|Lenalidomide and Dexamethasone|Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
16397154|NCT03939364|Drug|SBS-101|Isotretinoin Oral-Adhesive Film
16397155|NCT03939364|Drug|Placebo|Placebo
16397156|NCT03934905|Drug|sulforaphane|The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or sulforaphane caplets in a daily dose for 12 weeks of: two caplets for individuals <100 lb., four caplets for individuals 100-200 lb. and eight caplets for individuals >200 lb. Avmacol or placebo will be prescribed by Dr. Awasthi and will be dispensed by local pharmacy or study coordinators at TTUHSC/UMC Lubbock. We will be doing pill counts to make sure that volunteers have used as directed. We will measure the Sulforaphane level in plasma by well-established method.
16397157|NCT03934905|Drug|Placebo Oral Tablet|The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or sulforaphane caplets in a daily dose for 12 weeks of: two caplets for individuals <100 lb., four caplets for individuals 100-200 lb. and eight caplets for individuals >200 lb. Avmacol or placebo will be prescribed by Dr. Awasthi and will be dispensed by local pharmacy or study coordinators at TTUHSC/UMC Lubbock. We will be doing pill counts to make sure that volunteers have used as directed. We will measure the Sulforaphane level in plasma by well-established method.
16397158|NCT03933215|Drug|Cladribine Tablets|No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
16397159|NCT03933202|Drug|Cladribine Tablets|No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
16397160|NCT03927261|Drug|PRGN-3006 T Cells|Participants will receive a single intravenous (IV) administration of PRGN-3006 T Cells with or without lymphodepletion, and will be monitored for safety in the clinic for at least 7 days following infusion, and for safety, efficacy and correlative endpoints up to 12 months following infusion.
16397161|NCT03927144|Drug|Erenumab|Erenumab Dose 1 / Dose 2 Treatment Period up to 104 weeks
16397162|NCT03927144|Drug|Oral Prophylactic|"SoC oral prophylactic (active comparator) Treatment Period up to 52 weeks.
~Eligible treatment completers can roll over to post trial access open label treatment to receive 52 weeks of Erenumab Dose 1 / Dose 2."
16397171|NCT03919292|Drug|Neratinib|Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion). Doses of Neratinib are escalated in small groups of patients during the dose expansion portion of the study.
16397172|NCT03919292|Drug|Divalproex Sodium|Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion).
16397173|NCT03919071|Drug|Dabrafenib Mesylate|Given PO
16397174|NCT03919071|Radiation|Radiation Therapy|Undergo RT
16397175|NCT03919071|Drug|Trametinib Dimethyl Sulfoxide|Given PO
16397176|NCT03918278|Biological|MK-0482|IV infusion
16397177|NCT03918278|Biological|pembrolizumab|IV infusion
16397178|NCT03918278|Drug|Paclitaxel|IV infusion
16397179|NCT03918278|Drug|Nab-paclitaxel|IV infusion
16397180|NCT03918278|Drug|Gemcitabine|IV infusion
16397181|NCT03918278|Drug|Carboplatin|IV infusion
16397182|NCT03918278|Drug|Pemetrexed|IV infusion
16397189|NCT03910738|Drug|Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection|Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
16397190|NCT03910738|Drug|Placebo 4 mL Solution for Injection|Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
16397191|NCT03910738|Procedure|MRI|Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
16397192|NCT03910738|Behavioral|Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities|BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
16397193|NCT03910738|Behavioral|Assessment of disability|EDSS (Baseline, week 30 and 66)
16397208|NCT03896503|Drug|Berzosertib|Given IV
16397209|NCT03896503|Drug|Topotecan Hydrochloride|Given IV
16397213|NCT03893825|Drug|TV-46000|subcutaneous (sc) injection
16397214|NCT03893825|Drug|Placebo|Matching Placebo
16397215|NCT03890744|Drug|ModraDoc006/r|Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
16397216|NCT03887455|Drug|Lecanemab|10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
16397217|NCT03887455|Drug|Placebo|Biweekly (once every 2 weeks) administered i.v. infusion.
16397218|NCT03885037|Drug|Infliximab [infliximab biosimilar 3]|<Rheumatoid arthritis> The usual dose is 3 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have an incomplete response or reduced effects. These adjustments should be made in a stepwise manner. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks. This drug should be given in combination with methotrexate.
16397219|NCT03879161|Device|Vu-Path™|Femoral arterial access in eligible participants will be performed using the Vu-Path™.
16397225|NCT03869515|Other|No intervention|It's an observational study, so no intervention will be carried out.
16397229|NCT03863067|Procedure|Epiduroscopy|Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.
16397230|NCT03860038|Drug|TJ202 and Dexamethasone|one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
16397231|NCT03855995|Procedure|Whole blood sample|Whole blood samples will be collected from all enrolled children hospitalised and suspected of having an AESI or meningitis.
16397232|NCT03842969|Drug|RO7234292 (RG6042)|Intrathecal injection
16397233|NCT03842228|Drug|Copanlisib Hydrochloride|Given IV
16397234|NCT03842228|Biological|Durvalumab|Given IV
16397235|NCT03842228|Drug|Olaparib|Given PO
16397236|NCT03836417|Diagnostic Test|Microarray analysis|Microarray analysis to identify gene expression profiles that distinguish IPF from NSIP
16397237|NCT03835728|Drug|Ocrelizumab|Subjects will be randomized in a 1:1 fashion to receive infusion of Ocrelizumab (2 doses at 300 mg and 1 dose at 600 mg) or matched placebo. The 2 300 mg doses will be administered at day 2 and day 14. The 600 mg dose will be administered during the 6 month visit. The drug will be administered via infusion three times throughout the trial period: after the initial screening, at two weeks from initial infusion, and at 6 months.
16397238|NCT03835728|Drug|Saline|This will be the matching placebo used in the study.
16397239|NCT03834961|Drug|Larotrectinib Sulfate|Given PO or via NG or G tube
16397240|NCT03831503|Biological|INO-A002|Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).
16397241|NCT03831503|Device|CELLECTRA® 2000|Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.
16397242|NCT03831503|Device|Dengue Fever Antibodies (IgG)|To determine if the subject is Dengue seronegative at baseline
16397243|NCT03829657|Drug|ampreloxetine|Oral tablet, QD (Daily)
16397244|NCT03829657|Drug|Placebo|Oral tablet, QD
16397245|NCT03823300|Drug|Faricimab|Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
16397246|NCT03823300|Drug|Aflibercept|Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
16397247|NCT03823300|Procedure|Sham Procedure|The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.
16397248|NCT03823287|Drug|Faricimab|Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
16397249|NCT03823287|Drug|Aflibercept|Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
16397250|NCT03823287|Procedure|Sham Procedure|The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
16397251|NCT03820817|Drug|Rifaximin|Given PO
16397252|NCT03820726|Drug|Nintedanib|Bid
16397253|NCT03819829|Other|Blood sample|Blood sample
16397343|NCT03677739|Other|Informational Intervention|Receive information focusing on skin cancer
16397254|NCT03817463|Drug|Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor|Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
16397255|NCT03817463|Drug|Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor|Dipeptidyl peptidase-4 (DPP-4) inhibitor
16397256|NCT03811561|Drug|Semaglutide|Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).
16397257|NCT03811561|Drug|Placebo (semaglutide)|Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).
16397270|NCT03810417|Drug|Digoxin Antibodies Fab Fragments|Digoxin antibodies
16397271|NCT03810417|Other|Placebo|Saline
16397272|NCT03805750|Drug|CBD/THC|Oral formulation of CBD and THC.
16397273|NCT03805750|Drug|Placebo oral capsule|Placebo
16397274|NCT03803774|Drug|Birinapant|Given IV
16397275|NCT03803774|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRRT
16397276|NCT03799198|Other|Weight Management Program (WMP)|As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic.
16397277|NCT03799198|Drug|Medication for chronic weight management (Rx)|"Following listed 5 drugs will be administered as prescribed by the study doctor:
~1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin])."
16397278|NCT03794349|Biological|Dinutuximab|Given IV
16397279|NCT03794349|Drug|Eflornithine Hydrochloride|Given PO or via NG or G tube
16397280|NCT03794349|Drug|Irinotecan Hydrochloride|Given IV
16397281|NCT03794349|Biological|Sargramostim|Given SC or IV
16397282|NCT03794349|Drug|Temozolomide|Given PO or via NG or G tube
16397293|NCT03789097|Drug|Pembrolizumab|200 mg administered as an IV infusion over 30 minutes Q3W
16397294|NCT03789097|Drug|Flt3L|an immune cell growth factor. CDX-301 drug product is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains a nominal 2.5 mg/mL CDX-301 protein in a 1 mL volume of buffered solution composed of sodium phosphate and sodium chloride, with a pH of 7.0.
16397295|NCT03789097|Radiation|Radiation|The target site will get 2 small treatments of radiation.
16397296|NCT03789097|Drug|Poly ICLC|an immune cell activating factor. vials containing 1 ml of 2 mg/mL
16397297|NCT03778489|Other|Training|10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
16397298|NCT03777319|Drug|Spironolactone|Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.
16397299|NCT03777319|Drug|Prednisolone|Prednisolone will be prescribed for 6 months as the clinical standard of care.
16397300|NCT03775265|Drug|Atezolizumab|Given IV
16397301|NCT03775265|Drug|Cisplatin|Given IV
16397302|NCT03775265|Drug|Fluorouracil|Given IV
16397303|NCT03775265|Drug|Gemcitabine|Given IV
16397304|NCT03775265|Drug|Mitomycin|Given IV
16397305|NCT03775265|Other|Quality-of-Life Assessment|Ancillary studies
16397306|NCT03775265|Radiation|Radiation Therapy|Undergo 3DCRT or IMRT
16397307|NCT03775265|Other|Survey Administration|Ancillary studies
16397344|NCT03677739|Other|Informational Intervention|Receive information on healthy lifestyle
16397308|NCT03772691|Procedure|lateral suspension|• The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane. A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).
16397309|NCT03772691|Procedure|sacropexy|• The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures. The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.
16397310|NCT03764007|Drug|18F-Fluorocholine|Given intravenously
16397311|NCT03764007|Procedure|Positron Emission Tomography (PET)|Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
16397312|NCT03762291|Biological|CVD908ssb-TXSVN|"TXSVN may activate the immune system which is the participants body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports.
~Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin."
16397313|NCT03761095|Drug|PTC596|PTC596 will be administered as per the dose and schedule specified in the arm.
16397314|NCT03761095|Drug|Dacarbazine|Dacarbazine will be administered as per the dose and schedule specified in the arm.
16397315|NCT03752970|Drug|Spesolimab|Solution for infusion
16397316|NCT03752970|Drug|Placebo|Solution for infusion
16397317|NCT03745430|Drug|Ramucirumab|8 mg/kg (days 1 and 15, q4w) until disease progression
16397318|NCT03742141|Device|Intraoperative Video Laryngoscopy|The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.
16397319|NCT03742141|Drug|Glycopyrrolate|0.004mg/kg as per routine prior to intubation
16397320|NCT03739099|Device|Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions|Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
16397325|NCT03733990|Biological|FP-1305|The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
16397328|NCT03718793|Diagnostic Test|Peripheral exhaled nitric oxide|Small airway inflammation and dysfunction will be measured using the above mentioned tests.
16397329|NCT03714308|Drug|Ivt. Aflibercept (Eylea, BAY86-5321)|Treatment is applied according to routine clinical practice and independent of the study setting.
16397330|NCT03712267|Behavioral|Electronic Media Enhanced|Research assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments.
16397331|NCT03712267|Behavioral|Treatment as Usual|Research assistants will not review or provide participants' therapists with information from participants' electronic media and will compare with the Electronic Media Enhanced cohort to see if there was a difference in therapy outcomes.
16397332|NCT03708549|Drug|Berberine|The patients will randomly assigned to receive berberine (900 mg day-1, three times a day) and metformin simulant（750mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy
16397333|NCT03708549|Drug|Metformin|The patients will randomly assigned to receive metformin (750 mg day-1, three times a day) and berberine simulant（900mg day-1, three times a day） on the basis of the second-generation antipsychotics monotherapy
16397334|NCT03707587|Drug|M7824|Patients will receive 1200 mg intravenous (IV) of M7824 on day 1 of a 14 day cycle, every other week, for up to 12 weeks total treatment (6 cycles).
16397340|NCT03691402|Behavioral|MCT-Silver|Metacognitive training for depression in later life (MCT-Silver) is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and re-defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.
16397341|NCT03691402|Behavioral|Cognitive Remediation|mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.
16397342|NCT03686215|Combination Product|Study Device Arm|LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
16397345|NCT03677739|Other|Survey Administration|Ancillary studies
16397346|NCT03676634|Biological|rBV A/B|Recombinant Botulinum Vaccine A/B, rBV A/B
16397347|NCT03674736|Dietary Supplement|Dietary Intakes|Four levels of methionine or lysine intakes will be provided by the reference protein drinks, 3 levels of methionine from rice and wheat bread and 3 levels of lysine from chickpeas and lentils
16397348|NCT03673865|Device|office-based 3-dimensional printers (OB3DP)|In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
16397349|NCT03673865|Device|standard stock orbital plate|In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
16397350|NCT03671967|Drug|Piperacillin/tazobactam|4.5 grams QID
16397351|NCT03671967|Drug|Meropenem|1 gram TID
16397352|NCT03670017|Device|OptiScanner® 5000 Glucose Monitoring System|The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.
16397354|NCT03663933|Drug|Immunosuppression Only Conditioning|E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -9 and -5, cyclophosphamide:5 mg/kg orally daily on days -9 through -2
16397355|NCT03663933|Drug|Reduced Intensity Conditioning|E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -11 and -7, cyclophosphamide:3 mg/kg orally daily on days -11 through -4 Busulfan IV, pharmokinetically dosed, on days -3 and -2.
16397356|NCT03663933|Drug|GVHD Prophylaxis|High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, Mesna: 25-50 mg/kg weight based dosing, Tacrolimus 0.02mg /kg on days +5 through +90, and mycophenolate mofetil (MMF) 15 mg/kg on days +5 through +25
16397357|NCT03663933|Procedure|Allogeneic HSC|Stem cell transplant
16397363|NCT03648541|Drug|Spesolimab IV infusion|Solution for infusion
16397364|NCT03648541|Drug|Spesolimab SC solution for injection|Solution for injection
16397371|NCT03637023|Behavioral|Virtual Reality|Virtual Reality Based Rehabilitation including static balance, dynamic balance and walking
16397372|NCT03637023|Behavioral|Exercise Therapy|The conventional physical Therapy program includes parameters for improving strength, flexibility, transfers, posture, balance and coordination, and sensory stimulation. These activities consist of various types of exercises that focus on lower extremity movements.
16397373|NCT03636100|Device|Cryoballoon ablation|Cryoballoon ablation using standard equipment and techniques
16397374|NCT03635177|Procedure|Remote ischemic conditioning|Four weeks of daily ischemic conditioning and four weeks of sham ischemic conditioning in a cross over design
16397375|NCT03632135|Diagnostic Test|ChemoID assay|"The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill not only bulk of tumor cells, but importantly the cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs.
~The test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse."
16397376|NCT03632135|Drug|Chemotherapy|Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer
16397377|NCT03631654|Drug|Ivabradine|Ivabradine administration--tablets given 5 mg twice daily for 2 weeks, then 7.5 mg twice daily
16397378|NCT03631654|Drug|Placebos|Placebo
16397379|NCT03630809|Biological|HER2 DC1 Vaccine|Ultrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes.
16397380|NCT03627299|Drug|300mg glecaprevir/pibrentasivir 120mg|300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
16397381|NCT03622697|Behavioral|Mindfulness Meditation Phone Application|Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for at least 4 weeks with periodic survey assessments using validated psychometric tools.
16397382|NCT03622593|Drug|Aflibercept|Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
16397383|NCT03622593|Drug|Faricimab|Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
16397432|NCT03507101|Other|No intervention|No particular intervention or exposure is of particular interest
16397384|NCT03622593|Procedure|Sham Procedure|The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
16397385|NCT03616730|Diagnostic Test|NICOM (non-invasive cardiac output monitor)|Transthoracic bio-reactance, or the non-invasive cardiac output measurement [NICOMTM, Cheetah Medical Inc., Portland, OR] system, is a new technique that is able to measure multiple hemodynamic parameters with four transdermal electrodes placed on the patients' thorax. It is based on frequency- and phase-modulation of the voltage signal measured in response to an applied transthoracic current. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations and is a FDA-approved device.
16397386|NCT03599362|Drug|Nivolumab + Cabiralizumab|Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
16397387|NCT03599362|Radiation|Stereotactic Body Radiotherapy (SBRT)|Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.
16397388|NCT03593629|Combination Product|6-month PrEP + blood-based HIV self-test|Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
16397389|NCT03593629|Combination Product|6-month PrEP + oral fluid HIV self-test|Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
16397390|NCT03587116|Drug|Standard of Care FIX Replacement therapy|There is no investigational product being administered. Subjects will be administering their own standard of care FIX replacement therapy.
16397391|NCT03587116|Drug|Standard of Care FVIII Replacement therapy|There is no investigational product being administered. Subjects will be administering their own standard of care FVIII replacement therapy.
16397394|NCT03578081|Drug|Palonosetron Hydrochloride|Given IV
16397395|NCT03578081|Drug|Ondansetron Hydrochloride|Given IV or PO
16397396|NCT03578081|Drug|Dexamethasone|Given PO
16397397|NCT03578081|Drug|Fosaprepitant Dimeglumine|Given IV
16397398|NCT03578081|Drug|Olanzapine|Given PO
16397399|NCT03578081|Other|Placebo|Given IV
16397400|NCT03570892|Drug|Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy|Investigator's choice of optional platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP) + Lymphodepleting chemotherapy (fludarabine with cyclophosphamide or bendamustine) + Tisagenlecleucel (a second generation CAR-T composed of a CD19 antigen-binding domain, a 4-1BB costimulatory domain and a CD3-ζ signaling domain)
16397401|NCT03570892|Drug|Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)|"Investigator's choice of platinum-based immunochemotherapy (ie. R-ICE, R-GemOx, R-GDP, R-DHAP)+ High dose chemotherapy (ie. BEAM) + autologous HSCT.
~*Ibrutinib or lenalidomide may be used in patients who are no longer eligible for autologous HSCT after 2 cycles of immunochemotherapy"
16397402|NCT03564938|Drug|Regorafenib (Stivarga, BAY73-4506)|The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy).
16397403|NCT03547973|Drug|Sacituzumab Govitecan-hziy|Administered intravenously.
16397404|NCT03547973|Drug|Pembrolizumab|Administered per package insert
16397405|NCT03547973|Drug|Cisplatin|Administered per package insert
16397406|NCT03547973|Drug|Avelumab|Administered per package insert
16397410|NCT03524326|Drug|Lenvatinib Pill|24 mg oral daily
16397411|NCT03524326|Drug|Lenvatinib Pill|20 mg oral daily
16397412|NCT03524326|Drug|Lenvatinib Pill|14 mg oral daily
16397413|NCT03524326|Drug|Cetuximab|400mg/m2 IV, then 500mg/m2 IV weekly
16397414|NCT03524326|Drug|Lenvatinib Pill|10 mg oral daily
16397415|NCT03524326|Drug|Lenvatinib Pill|4 mg oral daily
16397416|NCT03524118|Drug|MK-1654|Single ascending doses of MK-1654 will be administered via IM injection.
16397417|NCT03524118|Drug|Placebo|Placebo (0.9% sodium chloride [NaCl]) will be administered via IM injection.
16397418|NCT03523468|Procedure|uniportal sleeve lobectomy|central lung cancer sleeve resection performed by uniportal VATS
16397419|NCT03523468|Procedure|open sleeve lobectomy|central lung cancer sleeve resection performed by open chest
16397420|NCT03521193|Device|patent foramen ovale closure|Pts undergoing PFO closure will receive 2-months of DAPT and 6 months of aspirin after patent foramen ovale (PFO) closure; they will be compared to healthy subjects on aspirin treatment
16397421|NCT03519178|Drug|PF-06873600|PF-06873600 tablet for oral dosing
16397422|NCT03519178|Drug|Endocrine Therapy 1|Endocrine Therapy 1
16397423|NCT03519178|Drug|Endocrine Therapy 2|Endocrine Therapy 2
16397424|NCT03518073|Drug|LY3303560|Administered IV
16397425|NCT03518073|Drug|Placebo|Administered IV
16397426|NCT03515083|Device|Alive Cor Kardia mobile electrocardiogram monitor|Mobile ECG monitor paired with smart phone application
16397427|NCT03512223|Drug|Dexamethasone|Intravenous and Perineural Dexamethasone for Brachial Plexus Block
16397428|NCT03511131|Behavioral|Queer Sex Ed|Comprehensive sexual health education program condition (Informational)
16397429|NCT03511131|Behavioral|Keep It Up|Culturally/situation-relevant HIV-prevention experimental condition (Motivational/behavioral)
16397430|NCT03511131|Behavioral|Keep It Up-Control|HIV knowledge control condition, attention-matched to KIU (Informational)
16397431|NCT03511131|Behavioral|Young Men's Health Project|Motivational enhancement video interviewing condition (Motivational/behavioral)
16397433|NCT03504137|Other|mHealth Intervention|The video DOT app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
16397434|NCT03499899|Drug|LAG525|LAG525, a concentrate for solution for intravenous infusion, comes in 100mg vials as a liquid formulation for infusion and is dosed at 400mg every 21 days.
16397435|NCT03499899|Drug|spartalizumab|Spartalizumab is a concentrate for solution for intravenous infusion, comes in 100mg vials as a liquid formulation for infusion and is dosed at 300mg every 21 days.
16397436|NCT03499899|Drug|carboplatin|Carboplatin is a concentrate for solution for intravenous infusion, comes in 100mg/mL and is dosed per AUC 6 every 21 days.
16397437|NCT03499756|Behavioral|Couple-based interpersonal psychotherapy|The contents include: (1) an overview of changes associated with the role transition of parenthood and an introduction to the coping skills relating to role transition and parenting; (2) discussing common postpartum and interpersonal difficulties, such as conflicts with partners or extended family, and teaching effective communication skills to resolve interpersonal conflicts and maintain a good interpersonal relationship; and (3) building family strengths and resources by enhancing family sense of coherence, such as reassessing the challenges of the new role, applying problem solving techniques to deal with role transition and interpersonal problems, and developing new social support.
16397438|NCT03489252|Device|Monitoring Device|Wear Fitbit Charge 3
16397439|NCT03477383|Diagnostic Test|donor-derived cell-free DNA (dd-cfDNA)|Measurement of dd-cfDNA and comparison against grade of rejection as measured by endomyocardial biopsy, taken simultaneously
16397440|NCT03468426|Drug|BI 836880|intra-venous infusion
16397441|NCT03468426|Drug|ezabenlimab|intra-venous infusion
16397442|NCT03462719|Drug|Ibrutinib|Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.
16397443|NCT03462719|Drug|Venetoclax|Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.
16397444|NCT03462719|Drug|Chlorambucil|Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.
16397445|NCT03462719|Drug|Obinutuzumab|Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.
16397446|NCT03462719|Drug|Ibrutinib (as Subsequent Therapy)|Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.
16397449|NCT03443674|Drug|SCB-313|Lyophilized powder in a single-use vial
16397450|NCT03441139|Other|Cryotherapy + Medical analgesics|"Percutaneous cryotherapy: A complete cycle of treatment will require 2 freezing 10-minutes periods, separate by a 9-minutes passive and 1-minute active thaw, with the cryoablation system. Dimension of the iceball coverage above the tumor will be monitored by non-contrast CT or MRI during the freezing cycle.
~Medical supportive care: Best analgesic therapy at investigator's discretion"
16397451|NCT03441139|Drug|Medical Analgesics|Best analgesic therapy at investigator's discretion
16397452|NCT03440229|Other|Emulsifier-containing diet|CMC is one of many synthetic dietary emulsifiers that are incorporated into a variety of processed foods. We have recently shown that, in mice, consumption of P80 and CMC, alters microbiota composition, have pro-inflammatory potential and promote microbiota encroachment into the colonic mucosa, low-grade inflammation, and metabolic syndrome. However, it is not known whether these compounds have similar effects in humans. We would like to study these effects in the human gut microbiota.
16397453|NCT03436862|Drug|Nivolumab|Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
16397454|NCT03431857|Device|TESS V2|Patients requiring the TESS V2 prosthesis.
16397458|NCT03426891|Drug|Pembrolizumab|200 mg intravenously (IV) every 3 weeks. The dose of pembrolizumab will remain the same throughout study treatment. During the maintenance phase, participants will receive pembrolizumab (for 12 months).
16397459|NCT03426891|Drug|Vorinostat|Dose Escalation Level -1 vorinostat 100 mg/day by mouth on days 1-5 every week during radiotherapy starting on first day of radiotherapy and 300 mg/day 1 week on 1 week off after radiotherapy. Level 1:vorinostat 200 mg/day by mouth on day 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 300 mg/day 1 week on 1 week off after radiotherapy. Dose Escalation Level 2: vorinostat 300 mg/day by mouth on days 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 400 mg/day 1 week on 1 week off after radiotherapy. Dose Expansion:all participants will receive the same dose of vorinostat that was determined to be most tolerated dose. During the maintenance phase, participants will receive vorinostat (for 12 months).
16397460|NCT03426891|Drug|Temozolomide|All participants will receive standard Temozolomide: Temozolomide (chemotherapy) 75 mg/m^2/day by mouth administered during the course of radiotherapy. Temozolomide will be administered continuously from Day 1 of radiotherapy to the last day of radiation. Maintenance Phase: temozolomide will start 4 weeks (+/- 3 days) after last dose of radiotherapy and will continue for 6 cycles post radiotherapy (150-200 mg/m^2/day, days 1-5 every 4 weeks) as per standard of care. During the maintenance phase, participants will receive Temozolomide (for the first 6 months).
16397461|NCT03426891|Radiation|Radiotherapy|All participants will receive standard radiotherapy: a total dose of 60 Gy administered in daily doses of 2 Gy, typically on a 5 days on / 2 days off schedule over 6 - 7 weeks.
16397462|NCT03426254|Biological|Injections Subcutaneously Talazoparib|Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28
16397463|NCT03426254|Drug|Oral capsules Talazoparib|Patients receive 1 mg of Talazoparib PO QD on days 1-28.
16397464|NCT03402282|Procedure|embolization|upper rectal artery embolization with coils
16397465|NCT03402282|Procedure|surgical repair|surgical repair through the classic technique (Milligan and Morgan technique)
16397469|NCT03386214|Drug|Pevonedistat|The amount of pevonedistat to be administered will be based on body surface area (BSA). BSA will be calculated using a standard formula on Cycle 1 Day 1, and on Day 1 of subsequent cycles if the patient experiences a > 5% change in body weight from the weight used for the most recent BSA calculation.
16397470|NCT03386214|Drug|Ruxolitinib|-Standard of care outside of protocol
16397471|NCT03386214|Procedure|Peripheral blood draw|"Baseline or Cycle 1 Day 1 (prior to study treatment administration)
~Cycle 2 Day 1 (prior to study treatment administration)
~Cycle 4 Day 1 (prior to study treatment administration)
~End of treatment"
16397472|NCT03386214|Procedure|Skin biopsy|A skin punch biopsy specimen will be collected at the baseline visit. One 6 mm punch biopsy of normal skin will be performed using standard techniques and local anesthesia.
16397477|NCT03361852|Drug|Rituximab|Rituximab is classified as a monoclonal antibody. It works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells
16397478|NCT03361852|Biological|Neo Vax|"Neo Vax is an experimental viral mimic and an activator of immunity."
16397479|NCT03361852|Drug|Pembrolizumab|Pembrolizumab is a monoclonal antibody that targets PD-1. It is a type of immunotherapy
16397480|NCT03359460|Drug|Ibrutinib|Given PO
16397481|NCT03359460|Drug|Lenalidomide|Given PO
16397482|NCT03356652|Procedure|Noninvasive electrical dyssynchrony study|"Ventricular activation maps will be acquired simultaneously with hemodynamic measurements using noninvasive mapping system (ECVUE, Medtronic Inc, USA). A thoracic computed tomographic scan will be acquired with the electrodes attached to the patient. Local ventricular activation times will be defined as the onset of the QRS complex or the pacing spike to the maximal negative slope of each unipolar electrogram.
~Pacing leads will be placed in high right atrium, His-bundle region, right ventricular apex, high septal RV, coronary sinus posterior/lateral branch, coronary sinus anterior branch, lateral and septal region of endocardial LV in order to deliver CRT in 8 different configurations."
16397483|NCT03356145|Drug|12 mL paracervical block|Injection of 12 mL of lidocaine
16397484|NCT03356145|Drug|20 mL paracervical block|Injection of 20 mL of lidocaine
16397485|NCT03351348|Drug|Bupivacaine|The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
16397486|NCT03351348|Behavioral|patient-reported pain scores|Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain.
16397487|NCT03351348|Other|saline|The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
16397490|NCT03342586|Diagnostic Test|Resting State fMRI (rsfMRI)|rsfMRI before receiving High-dose chemotherapy with autologous stem cell transplantation/HDC-ASCT (pre-HDC-ASCT), at approximately 3 months (+/- 2 weeks) after HDC-ASCT (early post-HDC-ASCT) and approximately 6months (+/- 2 weeks) after HDC-ASCT (late post-HDC-ASCT).
16397491|NCT03342586|Other|Auditory Attention and Executive Functions Test|"Trail Making Test (Parts A & B): Part A is a timed test of visual scanning and graphomotor speed; AT: 3 minutes. Part B is a timed measure of set-shifting; Administration Time (AT): 5 minutes. Test-retest reliabilities=0.64-0.94.
~Brief Test of Attention-BTA assesses auditory working memory; AT: 10 minutes. Test-re-test reliability=0.70.
~Controlled Oral Word Association Test-COWAT is a timed measure of phonemic verbal fluency. It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S). The subject is allowed 60 seconds per letter, and the resultant score is the total number of words produced. Test-retest reliability=0.88. AT: 5 minutes."
16397492|NCT03342586|Other|Memory Test|The Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R is a test of verbal learning and memory.
16397493|NCT03342586|Other|Motor Speed Test|Grooved Pegboard Test (GPT)-Dominant Hand and Non-Dominant Hand. It is a timed test of manual dexterity, in which the time to completion is scored separately for each hand.
16397494|NCT03342586|Other|Self Reported Quality of Life Questionnaire|The Functional Assessment of Cancer Therapy-Brain Cancer (FACT-BR Version 4) consists of 46 questions with five domains assessing physical well-being, social/family well-being, emotional well-being, functional well being, additional concerns. The neuropsychological and QOL assessments will be performed by a neuropsychologist or by a trained RSA under the neuropsychologist's direct supervision.
16397495|NCT03339128|Drug|Eluxadoline|Oral tablets
16397496|NCT03339128|Drug|Placebo|Oral tablets
16397497|NCT03335228|Device|Eclipse Easy Spin for PRP|Autologous platelet rich plasma is prepared from subject's blood with the Eclipse Easy Spin centrifuge and injected into affected areas.
16397498|NCT03334253|Drug|Atropine|Daily 0.01% atropine eyedrops
16397499|NCT03334253|Other|Placebo Eyedrops|Daily placebo eyedrops
16397533|NCT03263442|Drug|Thiamine|200 mg IV three times daily for seven days
16397504|NCT03329092|Drug|ATM-AVI|"(Creatinine clearance > 50 mL/min) 6500 mg ATM/2167 mg (loading dose, extended loading dose and maintenance dose) by iv infusion on Day 1 followed by a total daily dose of 6000 mg ATM/2000 mg AVI
~(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1417 mg AVI on Day 1 (loading dose, extended loading dose, maintenance dose) followed by total daily dose 3000 mg ATM/1000 mg AVI
~(Creatinine clearance 16 - 30 mL/min) 2700 mg ATM/900 mg AVI on Day 1 (loading dose, extended loading dose maintenance dose), followed by total daily dose 2025 mg ATM/675 mg AVI"
16397505|NCT03329092|Drug|MTZ|For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h
16397506|NCT03329092|Drug|MER|"Where pathogen initially not suspected of being MER-resistant:
~(Creatinine clearance > 50 mL/min) 1000 mg meropenem by 30 min iv infusion q8h
~(Creatinine clearance 26 - 50 mL/min) 1000mg meropenem by 30 min iv infusion q12h
~(Creatinine clearance 16 - 25 mL/min) 500 mg meropenem by 30 min iv infusion q12h
~Where pathogen initially suspected of being MER-resistant (Creatinine clearance > 50 mL/min) 2000 mg meropenem by 180 min iv infusion q8h
~(Creatinine clearance 26 - 50 mL/min) 2000 mg meropenem by 180 min iv infusion q12h
~(Creatinine clearance 16 - 25 mL/min) 1000 mg meropenem by 180 min iv infusion q12h"
16397507|NCT03329092|Drug|COL|"Loading dose 9 million IU by 30 -60 min iv infusion (6 million IU where weight < 60 kg) followed by one of the following maintenance doses:
~(Creatinine clearance > 50 mL/min) after a 12h interval, commence maintenance dosing 9 million IU daily in 2 or 3 divided doses by 30 -60 min iv infusions.
~(Creatinine clearance 31 - 50 mL/min) After a 24 hr interval, commence maintenance dosing of 6 million IU daily in 2 divided doses by 30 -60 min iv infusion
~(Creatinine clearance 21 - 30 mL/min) After a 24 hr interval, commence maintenance dosing 5 million IU daily in 2 divided doses by 30 -60 min iv infusion
~(Creatinine clearance 16 - 20 mL/min) after a 24 hr interval, commence maintenance dosing 4 million IU daily in 2 divided doses by 30 -60 min iv infusion"
16397508|NCT03323463|Diagnostic Test|F-FMISO PET/CT Scan|Every participant will undergo a pre-treatment F-FMISO scan PET/CT scan pretreatment. For both Cohort A and Cohort B, FMISO scan will be repeated between the 5th-10th RT day if pre-treatment scan is hypoxic
16397509|NCT03323463|Radiation|30 Gy over 3 weeks|Treatment will be delivered as one fraction per day on a standard 5 day per week schedule (excluding weekends and holidays), total of 30 Gy over 3 weeks at 2 Gy per fraction each day. The gross nodes, the primary/postoperative bed if applicable, all subclinical areas at risk for disease will receive the same dose at 30Gy.
16397510|NCT03323463|Drug|Cisplatin|Cycle 1 (week 1): At the start of week 1 of IMRT, subjects will receive cisplatin 100 mg/m2 intravenously. They may be given for 2 consecutive days (50 mg/m2 each day for a total dose 100 mg/m2), typically on days 1 and 2, or as a single dose, typically on day 1.
16397511|NCT03323463|Drug|Carboplatin|If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle (total dose of AUC 5). Cycle 2 (Week 4): After the three weeks of radiation at week 4 when the subject no longer is receiving radiation therapy, subjects will receive cisplatin 100 mg/m2 intravenously. The may be given for 2 consecutive days (50 mg/m2 each day for a total dose 100 mg/m2), typically on days 22 and 23, or as a single dose, typically on day 22.
16397512|NCT03323463|Drug|5Fluorouracil|If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over 96 hours).
16397513|NCT03323463|Radiation|Proton Therapy|Proton beam using pencil beam delivery either with the Varian or IBA delivery systems will be allowed for Cohort B. Proton beam therapy will be given at the New York Proton Center in New York City, where MSKCC has a well-established business associate agreement and cooperative research agreement with, respectively. If treatment at NYPC is not feasible, patients may be referred to ProCure in Somerset, NJ.
16397514|NCT03320070|Drug|Acthar Gel|Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
16397515|NCT03320070|Drug|Placebo|Placebo gel for SC injection
16397516|NCT03313180|Drug|Nintedanib|Administered twice daily
16397517|NCT03306706|Dietary Supplement|Whole pea muffins|2 muffins containing whole peas
16397518|NCT03306706|Dietary Supplement|Split pea muffins|2 muffins containing split peas
16397519|NCT03306706|Dietary Supplement|Wheat muffins|2 muffins containing wheat
16397520|NCT03291080|Drug|Liquid 13-Cis Retinoic Acid|Liquid 13-Cis Retinoic Acid
16397521|NCT03291080|Drug|Extracted capsules 13-CRA|Extracted capsules 13-CRA
16397522|NCT03289923|Other|sham TMS|Inactive Transcranial Magnetic Stimulation
16397523|NCT03289923|Device|MagPro X100 TMS Therapy System|FDA label standard Transcranial magnetic stimulation
16397524|NCT03289923|Behavioral|Self-System Therapy|Self-System Therapy (SST)
16397525|NCT03289923|Behavioral|Mindfulness exercises|Computer interfaced brief mindfulness exercises facilitated by the therapist
16397526|NCT03289923|Other|TMS+SST|Transcranial Magnetic Stimulation with Self System Therapy
16397527|NCT03289923|Other|Sham TMS + mindfulness exercises|Inactive Transcranial Stimulation with computer interfaced brief mindfulness exercises facilitated by the therapist
16397528|NCT03289923|Device|Cobot TS MV robotic arm for TMS|TMS-Cobot TS MV [Axilum Robotics] robotic arm for spatial positioning and orientation of the TMS coil
16397529|NCT03289923|Device|Magnetic Resonance Imaging scanner, 3T|MRI will be used to measure frontolimbic circuitry. The MRI collected before the intervention will be used to define the TMS target. The MRI collected before and after TMS will be compared to assess the effectiveness of TMS on brain circuitry.
16397530|NCT03282266|Procedure|PADN|PADN was performed at three sites at the conjunctional area between the distal main trunk and the ostial left branch. The following ablation parameters were programmed at each point: a temperature of 45 ℃-50 ℃, energy ≤15 W, and a time of 120 seconds. The procedure would cease for 10 seconds if the patient felt intolerable chest pain during the procedure. The EKG and pressure lines (including cardiac output) were monitored and continuously recorded throughout the procedure.
16397531|NCT03282266|Procedure|Sham operation|The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
16397534|NCT03263442|Drug|Normal saline|Normal saline IV three times daily for seven days
16397535|NCT03258554|Biological|Cetuximab|Given IV
16397536|NCT03258554|Biological|Durvalumab|Given IV
16397537|NCT03258554|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16397538|NCT03258554|Other|Laboratory Biomarker Analysis|Correlative studies
16397539|NCT03258554|Other|Quality-of-Life Assessment|Ancillary studies
16397540|NCT03258554|Other|Questionnaire Administration|Ancillary studies
16397541|NCT03248492|Drug|DS-8201a|DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
16397542|NCT03239483|Drug|Dapivirine gel|Dapivirine gel (0.05%); administered rectally
16397543|NCT03239483|Drug|Placebo gel|Universal HEC placebo gel; administered rectally
16397544|NCT03233191|Procedure|Digital Mammography|Undergo DM
16397545|NCT03233191|Procedure|Digital Tomosynthesis Mammography|Undergo TM
16397546|NCT03233191|Other|Laboratory Biomarker Analysis|Correlative studies
16397547|NCT03227263|Drug|Bevacizumab|Bevacizumab (Avastin®) concentrate at 25mg/mL is diluted at 5 mg/kg for infusion every 14 days for 6 consecutive administrations
16397548|NCT03227263|Drug|sodium chloride 0.9%|0.9% of sodium chloride is infused every 14 days for 6 consecutive administrations
16397549|NCT03223753|Other|Educational Intervention|Receive educational handouts about to physical activity
16397550|NCT03223753|Other|Internet-Based Intervention|Access limited version of device app/website
16397551|NCT03223753|Other|Internet-Based Intervention|Access full version of interactive reward-based device app/website
16397552|NCT03223753|Other|Laboratory Biomarker Analysis|Correlative studies
16397553|NCT03223753|Device|Medical Device Usage and Evaluation|Wear physical activity tracking device
16397554|NCT03223753|Other|Quality-of-Life Assessment|Ancillary studies
16397555|NCT03223753|Other|Questionnaire Administration|Ancillary studies
16397556|NCT03222570|Behavioral|Interpersonal Psychotherapy for Depressed Adolescents|IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.
16397557|NCT03222570|Drug|Selective Serotonin Reuptake Inhibitor|Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
16397558|NCT03222570|Other|Usual Care|Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
16397559|NCT03220854|Radiation|Stereotactic radiotherapy|Treatment will be planned to deliver a total of 18 to 60 Gy to the planning target volume (PTV) in 3 to 5 fractions over 1 to 2 weeks.
16397560|NCT03220854|Other|Biological: humanized anti-PD-1 monoclonal antibody|Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration
16397561|NCT03220854|Other|Biological: humanized anti-PD-L1 monoclonal antibody|Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration
16397564|NCT03218683|Drug|AZD5991|AZD5991 will be administered intravenously for 9 cycles (each cycle 21 days) or until patient derives treatment benefit or progresses
16397565|NCT03218683|Drug|AZD5991 + Venetoclax|Ascending oral doses of AZD5991 and/or venetoclax until no longer tolerated or disease progression
16397574|NCT03211416|Other|Laboratory Biomarker Analysis|Correlative studies
16397575|NCT03211416|Biological|Pembrolizumab|Given IV
16397576|NCT03211416|Drug|Sorafenib Tosylate|Given PO
16397577|NCT03206450|Procedure|Biospecimen Collection|Undergo collection of blood and provide saliva and semen samples
16397578|NCT03206450|Other|Laboratory Biomarker Analysis|Correlative studies
16397579|NCT03206450|Other|Questionnaire Administration|Ancillary studies
16397580|NCT03203681|Drug|Natesto|4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
16397588|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
16397589|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).
16397590|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).
16397591|NCT03194646|Other|Standard of care|Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
16397592|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
16397593|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
16397594|NCT03194646|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
16397596|NCT03188965|Drug|BAY1895344|Study drug will be administered as scheduled.
16397597|NCT03182244|Drug|gilteritinib|oral
16397598|NCT03182244|Drug|LoDAC (Low Dose Cytarabine)|subcutaneous (SC) or intravenous (IV) injection
16397599|NCT03182244|Drug|MEC (Mitoxantrone, Etoposide, Cytarabine)|intravenous
16397600|NCT03182244|Drug|FLAG (Granulocyte colony-stimulating factor (G-CSF), Fludarabine, Cytarabine)|intravenous
16397601|NCT03156595|Behavioral|Nurse interview|Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment. (If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
16397602|NCT03156595|Behavioral|Hypnosis sessions|Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
16397620|NCT03150368|Drug|ModraDoc006/r|Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
16397621|NCT03147378|Drug|ModraDoc006/r|Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets in fed or fasting condition
16397622|NCT03147040|Drug|Carboplatin|Chemotherapy treatment with carboplatin and atezolizumab
16397623|NCT03147040|Drug|Atezolizumab|Chemotherapy treatment with carboplatin and atezolizumab
16397624|NCT03142152|Device|Carillon Mitral Contour System|The CARILLON implant (mXE2) is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
16397625|NCT03142152|Other|Guideline Directed Heart Failure Medication|Heart failure medication per ACC/AHA guidelines
16397626|NCT03140670|Drug|RUCAPARIB|Rucaparib is a PARP inhibitor used as an anti-cancer agent. Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1.
16397627|NCT03136640|Drug|ModraDoc006/r|Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
16397632|NCT03125304|Other|acupuncture|They will be treated seven days before expected menstrual onset with once a day and three times a week for therapy. During the menstrual period,they will be treated everyday when they are having pain.Every treatment lasts 30 minutes. The trial period will consist of three menstrual cycles of treatment and three menstrual cycles in the follow-up period.
16397633|NCT03122288|Behavioral|Individualized Cognitive Training|These are specific computerized exercises that are designed to improve performance in particular cognitive domains (e.g., attention, speed of processing, verbal learning/memory).
16397634|NCT03122288|Other|No-Contact Control|This is simply a no-contact control group. Participants in this group will receive no additional contact with the study beyond the baseline and posttest assessments.
16397635|NCT03107520|Diagnostic Test|Intraoperative contrast-enhanced ultrasound (CEUS)|An intraoperative CEUS of the dysplastic femoral head will be performed after surgical reduction of the femoral head and during placement of the spica cast.
16397636|NCT03107520|Drug|Lumason|Administration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head.
16397637|NCT03100149|Drug|RO7046015|RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.
16397638|NCT03100149|Drug|RO7046015|RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.
16397639|NCT03100149|Drug|Placebo|RO7046015 placebo will be administered to all participants in the indicated arm.
16397646|NCT03092713|Behavioral|Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)|The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
16397647|NCT03092713|Behavioral|Control Group|The Control Group receives usual assessment and treatment at Oslo University Hospital.
16397652|NCT03084640|Drug|CMP-001|CMP-001 will be administered SC as per the dose and schedule specified in the respective arms.
16397653|NCT03084640|Drug|Pembrolizumab|Pembrolizumab will be administered as per the schedule specified in the respective arms.
16397654|NCT03084640|Drug|CMP-001|CMP-001 will be administered IT as per the dose and schedule specified in the respective arms.
16397655|NCT03072927|Device|MILD|MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Following epidurography, partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
16397656|NCT03067181|Other|Best Practice|Undergo observation
16397657|NCT03067181|Drug|Bleomycin|Given IV
16397658|NCT03067181|Biological|Bleomycin Sulfate|Given IV
16397659|NCT03067181|Drug|Carboplatin|Given IV
16397660|NCT03067181|Drug|Cisplatin|Given IV
16397661|NCT03067181|Drug|Etoposide|Given IV
16397662|NCT03067181|Drug|Etoposide Phosphate|Given IV
16397663|NCT03067181|Other|Laboratory Biomarker Analysis|Correlative studies
16397664|NCT03067181|Other|Pharmacogenomic Study|Correlative studies
16397665|NCT03067181|Other|Quality-of-Life Assessment|Ancillary studies
16397666|NCT03067181|Other|Questionnaire Administration|Ancillary studies
16397667|NCT03066778|Biological|Pembrolizumab|IV infusion on Day 1 of each cycle prior to chemotherapy
16397668|NCT03066778|Drug|Normal saline solution|IV infusion on Day 1 of each cycle prior to chemotherapy
16397669|NCT03066778|Drug|Carboplatin|IV infusion on Day 1 of each cycle
16397670|NCT03066778|Drug|Cisplatin|IV infusion on Day 1 of each cycle
16397671|NCT03066778|Drug|Etoposide|IV infusion on Days 1, 2 and 3 of each cycle
16397672|NCT03057626|Other|Cytology Specimen Collection Procedure|Undergo collection of blood and urine
16397673|NCT03057626|Other|Laboratory Biomarker Analysis|Correlative studies
16397674|NCT03057626|Other|Quality-of-Life Assessment|Ancillary studies
16397675|NCT03054376|Other|Immobilization|Full length cast of one leg R/L randomized
16397676|NCT03054376|Other|Training with non immobilized leg|Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks
16397677|NCT03054376|Other|Exercise training with both legs|Exercise training will be conducted regularly on a cycle ergometer during a four week period
16397678|NCT03053193|Diagnostic Test|MammaPrint, BluePrint, and Full-Genome Testing|Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
16397679|NCT03052010|Other|Integrated PrEP as a bridge to ART HIV-1 prevention strategy|The PrEP as a bridge to ART intervention will be introduced into clinics according to Kenya national guidelines using a stepped wedge design, stratified by region. The components of the intervention are: a) Couples' HIV-1 counseling and testing; 2) PrEP as a bridge to ART: PrEP offered prior to ART initiation in couples in which the HIV-1 infected partner is not on ART due to refusal/delay, during the first 6 months after ART start during viral decline, and then discontinuation; 3) ART at any CD4 count, offered to all HIV-1 infected partners, with ongoing promotion/counseling for those delaying/declining;4) Standard of care HIV-1 prevention services
16397680|NCT03052010|Drug|PrEP|A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.
16397681|NCT03052010|Drug|ART|ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.
16397682|NCT03043313|Drug|Trastuzumab|Given intravenously (into the vein; IV)
16397683|NCT03043313|Drug|Tucatinib|Given orally
16397689|NCT03006926|Drug|lenvatinib|4 mg capsules
16397690|NCT03006926|Drug|pembrolizumab (200 mg)|30-minute intravenous infusion
16397691|NCT03006393|Drug|Infliximab|One infusion of Infliximab (Remicade) will be administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
16397692|NCT03006393|Other|Placebo|One infusion of placebo treatment will be administered intravenously (IV) over a two hour period.
16397693|NCT03000829|Other|Tele-intensivist consultation|Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
16397756|NCT02826512|Drug|Niraparib|niraparib 300 mg QD continuously
16397694|NCT03000829|Other|"Simulated observation by ICU physician"|Display of silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site cardiac arrest team will be told that an intensive care physician is observing the mock code.
16397704|NCT02988960|Drug|ABBV-927|Intravenous
16397705|NCT02988960|Drug|ABBV-927|Intratumoral
16397706|NCT02988960|Drug|ABBV-181|Intravenous
16397707|NCT02981628|Drug|Cyclophosphamide|Given IV
16397708|NCT02981628|Drug|Cytarabine|Given IV or SC
16397709|NCT02981628|Biological|Inotuzumab Ozogamicin|Given IV
16397710|NCT02981628|Drug|Leucovorin Calcium|Given PO or IV
16397711|NCT02981628|Drug|Mercaptopurine|Given PO
16397712|NCT02981628|Drug|Methotrexate|Given IT
16397713|NCT02981628|Drug|Pegaspargase|Given IV or IM
16397714|NCT02981628|Drug|Vincristine|Given IV
16397716|NCT02977403|Behavioral|Attention Bias Retraining|Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
16397717|NCT02977403|Behavioral|Booster Attention Retraining|All subjects can opt to undergo attention bias training after the randomized phase of the study is complete
16397718|NCT02972398|Drug|N-acetylcysteine|Participants of interventional group receive 1000mg N-acetylcysteine twice daily for 12 weeks.
16397719|NCT02972398|Drug|placebo comparator of N-acetylcysteine|Participants of placebo group receive placebo comparator matching with N-acetylcysteine twice daily for 12 weeks.
16397720|NCT02971046|Other|varying protein intakes|"In healthy school-aged children: Four randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are 0.95, 1.3,1.55, and 2.0 grams per kilogram of bodyweight per day.
~In healthy young and old adults: Up to six randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are : 0.66, 0.8, 1, 1.2, and 1.5 grams per kilogram of bodyweight per day."
16397721|NCT02970799|Device|Intranasal Neurostimulator|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
16397723|NCT02943746|Dietary Supplement|Standard Protein Diet|Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day.
16397724|NCT02943746|Dietary Supplement|High Protein Diet|Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day.
16397725|NCT02925871|Behavioral|Co-designed person-centred care transitions|The intervention consists of several elements that aim to meet patients', significant others', and professionals' needs for shared understanding, patient preparedness for homecoming, and coordination.
16397726|NCT02925871|Behavioral|Current care transitions|Control group participants will receive current care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team
16397727|NCT02917278|Dietary Supplement|Meals|High Protein renal-specific meals
16397728|NCT02914470|Drug|carbplatin, cyclophophamide, atezolizumab|
16397735|NCT02903914|Drug|INCB001158|Arginase Inhibitor
16397736|NCT02903914|Drug|Pembrolizumab|PD-1 Inhibitor
16397737|NCT02884206|Drug|LCZ696|LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan
16397738|NCT02884206|Drug|Valsartan|Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696
16397739|NCT02884206|Drug|Placebo of LCZ696|Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets
16397740|NCT02884206|Drug|Placebo of Valsartan|Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets
16397741|NCT02864914|Drug|Empagliflozin|drug
16397742|NCT02864914|Drug|DPP-4 inhibitors|drug
16397743|NCT02852967|Drug|Belumosudil|
16397744|NCT02852967|Drug|Placebo|Placebo tablets matching belumosudil
16397745|NCT02839707|Drug|Atezolizumab|Given IV
16397746|NCT02839707|Biological|Bevacizumab|Given IV
16397747|NCT02839707|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16397748|NCT02839707|Other|Quality-of-Life Assessment|Ancillary studies
16397749|NCT02839343|Radiation|radiation therapy|
16397750|NCT02839343|Procedure|surgery|
16397751|NCT02839343|Drug|mFOLFIRINOX|oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV
16397752|NCT02839343|Drug|FOLFOX|oxaliplatin IV, leucovorin IV and 5-FU IV
16397757|NCT02819518|Biological|Pembrolizumab|IV infusion
16397758|NCT02819518|Drug|Nab-paclitaxel|IV infusion
16397759|NCT02819518|Drug|Paclitaxel|IV infusion
16397760|NCT02819518|Drug|Gemcitabine|IV infusion
16397761|NCT02819518|Drug|Carboplatin|IV infusion
16397762|NCT02819518|Drug|Normale Saline Solution|IV infusion
16397763|NCT02814695|Dietary Supplement|Vit E|0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (2 mg/ml) Vitamin E and incubated at 37o C for 30 minutes.
16397764|NCT02814695|Dietary Supplement|Yeast|0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (20 mg/ml) yeast extraction and incubated at 37o C for 30 minutes.
16397765|NCT02814695|Dietary Supplement|Vit C 1|0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.02 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.
16397766|NCT02814695|Dietary Supplement|Vit C 2|0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.04 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.
16397767|NCT02814695|Dietary Supplement|Vit C 3|0.1ml liquefied semen was mixed with 0.1ml Ham's F10 medium supplemented with (0.06 mg/ml) Vitamin C and incubated at 37o C for 30 minutes.
16397768|NCT02810951|Genetic|FCX-007|FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional COL7. FCX-007 cell suspension is injected intradermally.
16397769|NCT02810743|Drug|ddAC-CP-Olaparib|ddAC-CP-Olaparib
16397770|NCT02810743|Drug|ddAC-mini CTC|ddAC - mini CTC
16397771|NCT02807350|Device|Overminus treatment|spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
16397772|NCT02807350|Device|Non-overminus treatment|spectacles with full cycloplegic refraction without overminus
16397773|NCT02798224|Behavioral|e-assist: Colon Health|Online e-assist program uses educational messages and workflow tools. The intent is to reduce mental workload in terms of how to proceed by filtering and presenting information in a usable manner at a time of peaked situational awareness. The program will prompt patients to indicate their decision stage based on the Precaution Adoption Process Model. e-assist users are then prompted to view additional information and logistical assistance personalized for their decision stage.
16397774|NCT02798224|Behavioral|Healthwise Educational Program|Online access to fact sheets that provide basic information about colorectal cancer and screening.
16397775|NCT02793583|Biological|Ublituximab|
16397776|NCT02793583|Drug|Umbralisib|
16397777|NCT02793583|Biological|Bendamustine|
16397778|NCT02774746|Other|35-week delivery|Induction at 35 weeks gestational age
16397779|NCT02774746|Other|38-week delivery|Observation to spontaneous delivery or induction at 38 weeks gestational age
16397780|NCT02772679|Biological|PolyTregs+IL-2|PolyTregs will be infused into the patient in a single infusion. The first cohort will receive 3 x10^6 cells. The second cohort will receive 20x10^6 cells. Following the day 0 infusion of polyclonal Tregs, subjects will receive two 5-day courses of IL-2 (1 x 106 IU daily), the first on days 3-7 and the second on days 38-42. Administration of the second course of IL-2 may be delayed or withheld depending on threshold criteria for peripheral blood Treg frequencies and MMTT-stimulated C-peptide levels determined on day 28.
16397783|NCT02750865|Behavioral|Embodied Conversational Agent (ECA)|The ECA is a computer generated character who will interact with the subject on a daily basis via a touch-screen tablet. The system is designed to provide the following functions: (1) medication counseling; (2) physical activity promotion; (3) symptom management and continual screening for adverse events; and (4) alleviation of stress and anxiety. The investigators will augment the system to include: (5) spiritual needs assessment; and (6) advanced care planning.
16397784|NCT02729207|Drug|Esflurbiprofen Hydrogel Patch|One patch per day for 7 days
16397785|NCT02724579|Drug|Cisplatin|Given IV
16397786|NCT02724579|Drug|Cyclophosphamide|Given IV
16397787|NCT02724579|Other|Laboratory Biomarker Analysis|Correlative studies
16397788|NCT02724579|Drug|Lomustine|Given PO
16397789|NCT02724579|Radiation|Radiation Therapy|Undergo craniospinal radiation therapy
16397790|NCT02724579|Drug|Vincristine|Given IV or via minibag
16397791|NCT02724579|Drug|Vincristine Sulfate|Given IV or via minibag
16397792|NCT02709239|Dietary Supplement|DHA 200mg|4 50mg capsules of DHA to be taken by mouth daily
16397793|NCT02709239|Dietary Supplement|DHA 800mg|4 200mg capsules of DHA to be taken by mouth daily
16397795|NCT02698189|Drug|Birabresib Dose 20 mg|Administered as an oral capsule twice a day for 21 consecutive days per cycle.
16397796|NCT02697734|Drug|osilodrostat|In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.
16397797|NCT02697734|Drug|osilodrostat Placebo|Matching Placebo in the form of filmcoated tablets for oral administration
16397799|NCT02660710|Drug|R-CHOP|maximum of 6-8 cycles of R-CHOP over 18-24 weeks
16397800|NCT02655016|Drug|Niraparib|Niraparib will be administered.
16397801|NCT02655016|Drug|Placebo|Placebo will be administered.
16397803|NCT02609828|Drug|Tanezumab|Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
16397804|NCT02576990|Biological|Pembrolizumab|IV infusion
16397805|NCT02567422|Drug|Berzosertib|Given IV
16397806|NCT02567422|Drug|Cisplatin|Given IV
16397807|NCT02567422|Other|Laboratory Biomarker Analysis|Correlative studies
16397808|NCT02567422|Radiation|Radiation Therapy|Undergo radiation therapy
16397809|NCT02562235|Drug|Riociguat (Adempas, BAY63-2521)|For children with body-weight <50 kg at screening: body-weight adjusted dose equivalent to the exposure of (0.5 mg) 1.0 - 2.5 mg three times a day, IDT in adults treated for PAH; oral suspension. For children ≥50 kg at screening: 1.0 to 2.5 mg three times a day; oral tablet.
16397810|NCT02552823|Other|Group1|
16397811|NCT02552823|Other|Group2|
16397813|NCT02521493|Drug|Asparaginase|Given IM or IV
16397814|NCT02521493|Drug|Asparaginase Erwinia chrysanthemi|Given IM or IV
16397815|NCT02521493|Drug|Cytarabine|Given IT and IV
16397816|NCT02521493|Drug|Daunorubicin Hydrochloride|Given IV
16397817|NCT02521493|Drug|Etoposide|Given IV
16397818|NCT02521493|Other|Laboratory Biomarker Analysis|Correlative studies
16397819|NCT02521493|Drug|Mitoxantrone Hydrochloride|Given IV
16397820|NCT02521493|Drug|Thioguanine|Given PO
16397822|NCT02509442|Procedure|Diffusion of direct electric stimulation|During the neurosurgery awakened consisting in resecting a low-rank infiltrative glioma , the potential evoked further to the direct electric stimulation of the brain will be recorded by electroencephalography and electrocorticography.
16397823|NCT02508038|Procedure|TCRαβ+/CD19+ depleted Haploidentical HSCT|Patients with high-risk leukemia will receive myeloablative conditioning. All other patients will undergo a reduced-intensity conditioning with ATG, Fludarabine, Thiotepa and Melphalan followed by transplant with a KIR/KIR (Killer cell immunoglobulin-like recetptor) ligand mismatched haploidentical donor peripheral blood stem cell graft depleted of TCRab+ cells and CD19+ cells using the CliniMACS System.
16397824|NCT02508038|Drug|Zoledronate|Given IV. Patients will receive five doses of Zoledronate (each 1.25 mg/m2 at a 28 day interval) following transplant.
16397825|NCT02492711|Biological|Margetuximab|15 mg/kg via IV (intravenous) infusion over 120 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
16397826|NCT02492711|Biological|Trastuzumab|8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion over 30-90 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
16397827|NCT02492711|Drug|Capecitabine|1000 mg/m2 BID for 14 days in a 21-day cycle
16397828|NCT02492711|Drug|Eribulin|1.4 mg/m2 on days 1 and 8 of a 21-day cycle
16397829|NCT02492711|Drug|Gemcitabine|1000 mg/m2 on days 1 and 8 of a 21-day cycle
16397830|NCT02492711|Drug|Vinorelbine|25-30 mg/m2 on days 1 and 8 of a 21-day cycle
16397831|NCT02488655|Device|Echopulse|HIFU Under ultrasound guidance
16397832|NCT02484716|Drug|Timolol nasal spray|Timolol 0.5% is administered by the patient with a posology of one spray (50 µL) in each nostril twice a day for 4 weeks.
16397833|NCT02484716|Drug|Placebo nasal spray|Placebo (NaCl) is administered by the patient with a posology of one spray (50 µL) in each nostril twice a day for 4 weeks.
16397875|NCT02464969|Drug|Apixaban|Tablet or Solution
16397876|NCT02464969|Drug|Standard of Care|Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.
16397877|NCT02463227|Biological|VRC01|"40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.
~Administered over about 30 to 60 minutes using a volumetric pump."
16397889|NCT02434263|Device|Hydra TAVI|Percutaneous Replacement of the Diseased Aortic Valve
16397890|NCT02423057|Drug|TdCyd|Methylation-mediated silencing of genes is an epigenetic mechanism implicated in carcinogenesis; agents that inhibit this mechanism are of clinical interest because of their potential to re-activate silenced tumor suppressor genes. The nucleoside analog 4'-thio-2'-deoxycytidine (TdCyd) is incorporated into DNA where it engages the active site of DNA methyltransferase I (DNMT1), a maintenance methyltransferase that contributes to the hypermethylation and silencing of tumor suppressor genes. TdCyd offers an improvement over current DNMT inhibitors by virtue of a higher incorporation rate into DNA at lower levels of cytotoxicity; treatment with TdCyd is anticipated to result in the inhibition of tumor growth due to DNMT1 depletion at oral doses that are well tolerated in extended dosing schedules.
16397891|NCT02418195|Drug|ketamine|IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
16397892|NCT02409654|Other|Patient education|(i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion
16397893|NCT02409654|Other|Routine care|The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
16397894|NCT02402244|Other|Cytology Specimen Collection Procedure|Undergo cytology specimen collection
16397895|NCT02402244|Other|Medical Chart Review|Undergo medical data review
16397900|NCT02398617|Other|Decision Making Intervention|At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.
16397901|NCT02395367|Procedure|resection|This is an observational study. And we are interested in observing the outcome of different treatment methods.
16397902|NCT02395367|Radiation|adjuvant radiotherapy|This is an observational study. And we are interested in observing the outcome of different treatment methods.
16397903|NCT02395367|Drug|neoadjuvant chemotherapy or adjuvant chemotherapy|This is an observational study. And we are interested in observing the outcome of different treatment methods.
16397904|NCT02390531|Drug|Bevacizumab|Varying dosages in 10µl
16397905|NCT02385292|Device|Oculeve Intranasal Lacrimal Neurostimulator|The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
16397906|NCT02366195|Drug|Talimogene Laherparepvec|The initial dose of talimogene laherparepvec is up to 4.0 mL of 10^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10^8 PFU/mL.
16397908|NCT02362438|Genetic|scAAv9/JeT-GAN|scAAV9/JeT-GAN is a biological gene transfer reagent
16397909|NCT02352896|Drug|EPI-743|EPI-743 100 milligrams/milliliter (mg/mL) oral solution will be administered per dose and schedule specified in the arm.
16397910|NCT02343549|Device|NovoTTF100A|
16397911|NCT02343549|Drug|Bevacizumab|
16397912|NCT02343549|Drug|Temozolomide|
16397916|NCT02326883|Behavioral|Care Management|The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treating mental health and primary care providers (ongoing usual care) using Epic Staff Messaging (or telephone contacts if necessary).
16397917|NCT02326883|Behavioral|Skills Training|The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills.
16397918|NCT02326883|Behavioral|Usual Care|Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers.
16397919|NCT02308124|Drug|Midodrine|
16397920|NCT02308124|Drug|Pyridostigmine Bromide|
16397921|NCT02308124|Drug|Midodrine + pyridostigmine|
16397922|NCT02298023|Biological|allogenic adipose stem cell injection|Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.
16397923|NCT02298023|Biological|fibrin glue/normal saline injection|Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise
16397924|NCT02298023|Biological|normal saline injection|Total 1cc of normal saline injection and range of motion exercise
16397925|NCT02285179|Drug|GDC-0032|Dose of GDC-0032 given orally, once daily (total daily dose) level -1: 2 mg Q.O.D GDC-0032 level 1: (starting) 2 mg QD for 21 days, 7 days off and tamoxifen 20 mg qd level 2: 4 mg QD for 21 days, 7 days off and tamoxifen 20 mg qd
16397926|NCT02285179|Drug|Tamoxifen|daily dose of 20 mg
16397927|NCT02258451|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update)
16397928|NCT02258451|Drug|Placebo (saline)|Up to 6 cycles of saline injection
16397929|NCT02258451|Drug|Exemestane|Administration of exemestane will be in accordance to the local label and/or in line with local standard of practice.
16397930|NCT02258451|Drug|Everolimus|Administration of everolimus will be in accordance to the local label and/or in line with local standard of practice.
16397936|NCT02218996|Other|Psychosocial treatment|Regular psychosocial treatment in clinical outpatient service.
16397954|NCT02176967|Drug|Carboplatin|Given IV
16397955|NCT02176967|Other|Clinical Observation|Undergo clinical observation
16397956|NCT02176967|Drug|Cyclophosphamide|Given IV
16397957|NCT02176967|Drug|Doxorubicin Hydrochloride|Given IV
16397958|NCT02176967|Drug|Etoposide|Given IV
16397959|NCT02176967|Other|Laboratory Biomarker Analysis|Correlative studies
16397960|NCT02176967|Other|Pharmacological Study|Optional correlative studies
16397969|NCT02126878|Drug|Kenalog|
16397972|NCT02088372|Device|Vanguard with E1 PS Bearing|Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
16397973|NCT02087449|Device|E1-Hip Bearing|Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E.
16397974|NCT02043847|Radiation|Total Marrow Irradiation|Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day
16397975|NCT02043847|Drug|Melphalan|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
16397976|NCT02043847|Drug|Filgrastim (G-CSF)|Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.
16397977|NCT02043847|Procedure|Autologous transplant|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
16397978|NCT02043847|Radiation|Total Marrow Irradiation|Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
16397979|NCT02043847|Drug|Melphalan|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
16397980|NCT02043847|Drug|Filgrastim (G-CSF)|Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days
16397981|NCT02043847|Procedure|Autologous transplant|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
16397982|NCT02043847|Radiation|Total Marrow Irradiation|Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
16397983|NCT02043847|Drug|Melphalan|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
16397984|NCT02043847|Drug|Filgrastim (G-CSF)|Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days
16397985|NCT02043847|Procedure|Autologous transplant|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
16397988|NCT01996267|Drug|PTC+Pertuzumab|Cycle repeated every 21 days
16397989|NCT01996267|Drug|FEC-T+Pertuzumab|Cycle is repeated every 21 days
16397990|NCT01967888|Drug|Reparixin|Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour
16397991|NCT01967888|Drug|Placebo|Physiologic solution administered at 0.25 mL/kg/hour
16397992|NCT01950689|Drug|Nimorazole|
16397993|NCT01950689|Radiation|Radiotherapy|
16397994|NCT01908777|Other|High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin|
16397995|NCT01898117|Drug|Carbo/cyclo|
16397996|NCT01898117|Drug|Carbo/cyclo + atezolizumab|
16397997|NCT01898117|Drug|Paclitaxel|
16397998|NCT01898117|Drug|Paclitaxel + Atezolizumab|
16397999|NCT01896999|Drug|Brentuximab Vedotin|Given IV
16398000|NCT01896999|Biological|Ipilimumab|Given IV
16398001|NCT01896999|Biological|Nivolumab|Given IV
16398002|NCT01856478|Drug|methotrexate|intravenous bolus injection, once weekly
16398003|NCT01856478|Drug|afatinib|oral intake, once daily
16398004|NCT01851369|Drug|TRC 102|TRC102 has been shown to potentiate the activity of temozolomide by preventing BER and allowing cleavage of TRC102 bound DNA, which will cause DNA strand breaks in cancer cells. We hypothesize that oral TRC102 can be safely co-administered with TMZ and would potentiate DNA damage caused by TMZ resulting in antitumor responses.
16398005|NCT01821131|Other|muffin|
16398006|NCT01817426|Drug|Infliximab|
16398007|NCT01817426|Other|Placebo|
16398020|NCT01736618|Device|S-ICD System|
16398021|NCT01716806|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by IV infusion
16398022|NCT01716806|Drug|bendamustine|70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
16398023|NCT01716806|Drug|dacarbazine|375 mg/m^2 every 3 weeks by IV infusion
16398024|NCT01716806|Drug|nivolumab|3 mg/kg every 3 weeks by IV infusion
16398025|NCT01696435|Dietary Supplement|vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day
16398026|NCT01696435|Drug|omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16398027|NCT01696435|Dietary Supplement|Fish oil placebo|Fish oil placebo
16398028|NCT01696435|Dietary Supplement|Vitamin D placebo|Vitamin D placebo
16398029|NCT01666340|Other|Exercise intervention|Group asked to perform exercise at a given moderate intensity for a set time
16398030|NCT01666340|Other|Exercise intervention|High intensity exercise
16398031|NCT01666210|Drug|OTX-DP (Dexamethasone punctum plug)|Sustained and tapered release of dexamethasone from hydrogel punctum plug
16398032|NCT01666210|Drug|Placebo Vehicle Punctum Plug|Hydrogel punctum plug without dexamethasone
16398033|NCT01621594|Device|The Toshiba Aquilion ONE CT system|To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.
16398034|NCT01610947|Drug|Adalimumab, Etanercept, Golimumab or infliximab|Continuation of usual treatment with fixed intervals according to standard recommendations
16398035|NCT01610947|Drug|Adalimumab, Etanercept, Golimumab or infliximab|Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol
16398036|NCT01604317|Procedure|Resuscitation-torso plastic bag|Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
16398037|NCT01604317|Procedure|Resuscitation-partial-head plastic bag|Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
16398038|NCT01587144|Drug|Lucanthone|Lucanthone will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
16398039|NCT01587144|Drug|Temozolomide (TMZ)|"TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
~Cycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs."
16398040|NCT01587144|Radiation|Radiation|60 Gy administered in 30 fractions for 42 days in the concomitant phase.
16398041|NCT01587144|Drug|Placebo|Placebo will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.
16398043|NCT01551745|Biological|Vigil™ Vaccine|Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
16398044|NCT01551745|Drug|Bevacizumab|Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
16398045|NCT01517100|Drug|Nabllone|CB Agonist
16398046|NCT01517100|Drug|CP-945,598|Cannabinoid Receptor 1 antagonist
16398047|NCT01517100|Procedure|Hypoglycemic Clamp|Assesses beta cell response
16398048|NCT01517100|Drug|Euglycemic-Hyperinsulinemic Clamp|Measures insulin sensitivity
16398049|NCT01515787|Drug|FOLFOX (chemotherapy)|Oxaliplatin 85 mg/m^2 IV over 2 hours on day 1, leucovorin 400 mg/m^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m^2 bolus over 5-15 minutes then 2400 mg/m^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
16398050|NCT01515787|Other|5 FUCMT (chemoradiation)|5-fluorouracil 225 mg/m^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
16398051|NCT01515787|Procedure|surgery|low anterior resection with total mesorectal excision
16398052|NCT01515787|Procedure|magnetic resonance imaging or endorectal ultrasound|
16398053|NCT01507480|Drug|Bevacizumab|There are five increasing doses of bevacizumab nasal spray (25mg/mL): 10 mg, 25 mg, 50 mg, 75, mg and 100 mg. Each test dose is a single dose divided into five fractions and administered into each nostril every 30 minutes for 2 hours:
16398054|NCT01479686|Procedure|iMRI|3.0TiMRI guided resection in adults with glioma
16398055|NCT01479686|Procedure|conventional neuronavigation|conventional neuronavigation guided resection in adults with glioma
16398056|NCT01370447|Drug|EPI-743|EPI-743 (oral solution [100 mg/mL] or liquid-filled capsules [100 mg or 200 mg]) will be administered per dose and schedule specified in the arm.
16398057|NCT01327105|Device|TVU|Use of transvaginal ultrasound to determine location of micro-insert
16398061|NCT01273168|Drug|Z-Endoxifen|Genetic polymorphisms in CYP2D6 and concomitant medications alter tamoxifen metabolism, limiting exposure to the active metabolite endoxifen. These factors are associated with a higher rate of recurrence and shorter disease-free survival in breast cancer patients receiving tamoxifen. Administration of endoxifen directly to patients is anticipated to bypass the effects of CYP2D6 polymorphisms and concomitant medications and provide adequate active drug levels in all treated patients, resulting in clinical benefit
16398062|NCT01252953|Drug|Anacetrapib|tablet, 100mg daily
16398063|NCT01252953|Drug|Placebo anacetrapib|tablet, 1 tablet daily
16398077|NCT01143558|Device|Lyme Disease Xenodiagnosis|Clean laboratory-bred ticks are the FDA registered IDE. These ticks are placed on patients to search for evidence of Borrelia burgdorferi.
16398078|NCT01092182|Drug|EPOCH-R|Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
16398079|NCT01092182|Drug|EPOCH-RR|Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 3 cycles
16398080|NCT01068210|Behavioral|Exercise Training|The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
16398081|NCT01068210|Behavioral|Progressive Stretching|The ultimate goal for the progressive stretching program is 3 individual stretching sessions. All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
16398082|NCT01057069|Drug|Carboplatin and Paclitaxel|Carboplatin AUC = 6, Q 3 weeks, 3 courses Paclitaxel 80 mg/m2, weekly, 9 administrations
16398083|NCT01057069|Drug|Doxorubicin, cyclophosphamide|Two-weekly administrations of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.
16398084|NCT01057069|Drug|Doxorubicin, cyclophosphamide, carboplatin, thiotepa, cyclophosphamide|"One course of of 600 mg/m2 cyclophosphamide and 60 mg/m2 doxorubicin. PEG-filgrastim (Neulasta(r)) will be administered on the day following chemotherapy.
~This course is followed by Peripheral Blood Progenitor Cell (PBPC) harvest and tandem intermediate-dose alkylating therapy (miniCTC, carboplatin 800 mg/m2, thiotepa 250 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion."
16398087|NCT00984399|Drug|Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist|The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol.
16398089|NCT00942357|Drug|Carboplatin|Given IV
16398090|NCT00942357|Drug|Cisplatin|Given IV
16398091|NCT00942357|Radiation|Internal Radiation Therapy|Undergo brachytherapy
16398092|NCT00942357|Drug|Paclitaxel|Given IV
16398093|NCT00942357|Other|Quality-of-Life Assessment|Ancillary studies
16398094|NCT00942357|Radiation|Radiation Therapy|Undergo radiation therapy
16398095|NCT00918190|Drug|Placebo|Saline
16398096|NCT00918190|Drug|Ondansetron, Dexamethasone|Use of ondansetron and dexamethasone as combined antiemetics
16398097|NCT00918190|Drug|Midazolam, dexamethasone|use of midazolam and dexamethasone as combined antiemetic
16398101|NCT00739141|Drug|fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft|Cyclophosphamide 50 mg/kg/dose x 1 IV day -6 (1 dose) Fludarabine 30 mg/m2/dose x 5 IV days -6 to -2 (5 doses) Thiotepa 5 mg/kg/dose x 2 IV days -5 to -4 (2 doses) TBI 200 cGy/dose x 2 days -2 to -1 (2 doses). On transplant day, the cord blood cells will be given through your catheter. The immune suppressing drugs you will receive are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through your catheter. Later they can be given as tablets.
16398104|NCT00696111|Drug|Depot Lupron followed by estrogen plus placebo|A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.
16398105|NCT00696111|Drug|Depot Lupron followed by progesterone plus placebo.|A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of progesterone (200mg) plus placebo for six weeks.
16398106|NCT00696111|Device|CPAP|CPAP (continuous positive airway pressure) treatment at home for six weeks.
16398108|NCT00669734|Biological|Falimarev|Given intratumorally or SC
16398109|NCT00669734|Biological|Inalimarev|Given SC
16398110|NCT00669734|Other|Laboratory Biomarker Analysis|Correlative studies
16398111|NCT00669734|Biological|Sargramostim|Given SC
16398114|NCT00610688|Drug|Prenatal Vitamin|Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
16398115|NCT00610688|Drug|Cholecalciferol (Vitamin D3)|Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
16398116|NCT00610688|Drug|Cholecalciferol (Vitamin D3)|Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
16398117|NCT00592124|Drug|Tenofovir disoproxil fumarate|300 mg tablet daily
16398118|NCT00592124|Drug|Tenofovir gel|1 gm/100 ml of 1% gel vaginally daily
16398119|NCT00344487|Drug|Lopinavir/Ritonavir|Dosing of Kaletra will be per package insert and BID with food. A three-drug standard of care antiretroviral regimen will be used in this study. Subjects will enter the study already on an effective, virally-suppressive treatment regimen. One of these drugs will be substituted for Lopinavir/ritonavir (Kaletra®). However, the nucleoside/nucleotide backbone drugs that the subject is already on will remain the same.
16398120|NCT00212134|Device|Contact lens correction of aphakia|optical correction of infant surgical aphakia with Contact lens
16398121|NCT00212134|Device|Intraocular lens implantation|optical correction of surgical aphakia with intraocular lens
16398137|NCT00063999|Drug|Carboplatin|Given IV
16398138|NCT00063999|Drug|Cisplatin|Given IV
16398139|NCT00063999|Drug|Doxorubicin Hydrochloride|Given IV
16398140|NCT00063999|Biological|Filgrastim|Given SC
16398141|NCT00063999|Other|Laboratory Biomarker Analysis|Correlative studies
16398142|NCT00063999|Drug|Paclitaxel|Given IV
16398143|NCT00063999|Biological|Pegfilgrastim|Given SC
16398144|NCT00063999|Other|Quality-of-Life Assessment|Ancillary studies
16398151|NCT00007150|Procedure|Phlebotomy|Therapeutic phlebotomy, the periodic, frequent removal of iron contained in the hemoglobin of red blood cells.
16398154|NCT05086432|Other|Sputum-guided management|As previously described.
16398155|NCT05086432|Other|Standard of Care|As previously described.
16398156|NCT05086419|Other|Sub-symptom threshold aerobic exercise|For the first three weeks, participants will be offered guided sub-symptom threshold aerobic exercise on a treadmill or exercise bike once a week. The remaining 2-4 sub-symptom threshold aerobic exercise workouts per. week will be on their own. Location and mode of exercise (treadmill, walking, jogging, exercise bike / bicycle, swimming, or elliptical machine) will be individually adapted to the patients experience, preferences and opportunities. The intensity of the sub-symptom threshold aerobic exercise will always be monitored using a heart rate monitor and/or ratings of perceived exertion (Borg RPE). If there still is a need for closer follow-up after the first three weeks, a physiotherapist in primary health care service will be involved under supervision from a physiotherapist (research fellow) in the project.
16398157|NCT05086406|Other|Combination of Video and Virtual Pre-operative Counseling|Intervention will be a pre-operative counseling video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications.
16398158|NCT05086393|Drug|Duloxetine|Patients will be randomized to receive Duloxetine or a placebo.
16398159|NCT05086393|Drug|Placebos|Patients will be randomized to receive Duloxetine or a placebo.
16398160|NCT05086380|Behavioral|Mindfulness-based stress reduction therapy|MBSR Therapy is a structured 8-week program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic and psychiatric disorders. The program is based upon a systematic procedure to develop enhanced awareness of moment-to-moment experience of perceptible mental processes.
16398161|NCT05086380|Device|Inhibitory TMS|The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
16398162|NCT05086380|Behavioral|Psychoeducation|Participants will learn about the symptoms and how to cope with the symptoms
16398163|NCT05086380|Device|TMS sham|The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
16398164|NCT05086380|Device|Excitatory TMS|The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
16398165|NCT05086367|Other|Diaphragmatic and pursed lip breathing|Breathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.
16398166|NCT05086367|Other|Routine Physical Therapy|Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed
16398167|NCT05086354|Behavioral|JUMP|Warm-up, stretching, jumping rope, cool-down
16398168|NCT05086341|Device|My COPD|In addition to usual care, participants in the intervention group will initially meet with a physiotherapist to set up an individualized exercise program and physical activity plan. Participants will also receive a device instruction manual and a one hour of face-to-face training on how to use My COPD. The 12-week intervention is home-based, and self-managed with support from physiotherapist via My COPD. In addition to warm-up exercises, the exercise program comprises five exercises targeting major muscle groups, as well as, balance and aerobic exercise, to be conducted at least twice weekly. Via My COPD, the physiotherapists can follow activities and progress the exercise program, and the physiotherapist and the participants can contact each other. Throughout the intervention period, technical support will be available.
16398169|NCT05086328|Behavioral|Nonviolent Resistance|Six two weekly sessions of two hours, based on nonviolent resistance Questionnaires pre and post intervention
16398170|NCT05086315|Drug|SAR443579|Powder for solution for infusion; by IV infusion
16398171|NCT05086289|Drug|LY3526318|Administered orally
16398172|NCT05086289|Drug|Placebo|Administered orally
16398173|NCT05086276|Drug|FX-322|Active Comparator
16398174|NCT05086276|Drug|Placebo|Placebo
16398180|NCT05086237|Other|Text message reminders|Text messages will be sent to parents/guardians of children ages 0 to 17 years who missed their well child visits.
16398181|NCT05086224|Drug|Hematoma Local Anesthetic Block Procedure with 1% Lidocaine|Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
16398182|NCT05086224|Drug|Bier Anesthetic Block Procedure with 1% Lidocaine|Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.
16398183|NCT05086211|Other|proprioceptive neuromuscular facilitation|"Each session including three proprioceptive neuromuscular facilitation techniques:
~Balance training exercises,participants will be treated for 20 minutes with PNF techniques that included;Rhythmic initiation, slow reversal techniques practiced with D1 and D2 pattern in lower limb,repeated contraction and Resisted PNF.The Technique will be performed for 3 days per week in same order on all subjects."
16398184|NCT05086211|Other|pertubation based balance training|Each session will include a 5-10min warm-up,voluntary tasks intended to induce internal perturbations,voluntary tasks combined with external perturbations and a 5-10mins cool down.The technique will be performed for 2 sets of 10 repetitions on all subjects
16398187|NCT05086185|Diagnostic Test|Kalemic Response to Orange Juice|100% pulp-free orange juice
16398188|NCT05086185|Dietary Supplement|Kalemic Response to Orange Juice with Fiber|100% pulp-free orange juice with psyllium-based fiber added
16398189|NCT05086172|Behavioral|Ultrabrief Behavioral Activation|The ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of behavioral activation (BA) is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes.
16398193|NCT05086133|Device|transcranial magnetic stimulation|transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
16398194|NCT05086133|Device|sham stimulation|TMS coil vertical to the brain surface, with same protocol as cTBS
16398196|NCT05086107|Drug|BV100|Rifabutin for infusion
16398197|NCT05086094|Drug|BHV3241, verdiperstat|BHV3241/Verdiperstat 600mg BID
16398198|NCT05086081|Drug|Ticagrelor 90mg|Any ticagrelor dispensing claim is used as the exposure group
16398199|NCT05086081|Drug|Prasugrel 10mg|Any prasugrel dispensing claim is used as the reference group
16398200|NCT05086068|Device|Arthrosamid|Intra-articular hydrogel injection comprising of water and cross-linked polyacrylamide.
16398201|NCT05086055|Behavioral|Kinematic movement analysis|moving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements.
16398202|NCT05086042|Diagnostic Test|Ultrasonography, Magnetic resonance imaging|The cross-sectional area of the median nerve was measured with US and MRI.
16398203|NCT05086029|Diagnostic Test|Superb Microvascular Imaging|Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.
16398204|NCT05086016|Device|Catheterized Stenting|Catheterized stenting of vascular narrowings.
16398206|NCT05085990|Biological|TARA-002|Phase 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)
16398207|NCT05085977|Biological|TARA-002|Phase 1a, Dose Escalation: Up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner
16398208|NCT05085964|Drug|RNA antisense oligonucleotide for intravitreal injection|"QR-421a will be first administered to the fellow eye (as defined in the preceding study), and will be repeated every 6 months.
~Treatment of the study eye (as defined in the preceding study) can commence 3 months (9 months for subjects from study PQ-421a-001) after the treatment of the fellow eye has been initiated and will be repeated every 6 months as well.
~Continued subject treatment in this study will be pursued provided that the benefit-risk balance is positive for the individual subject."
16398209|NCT05085951|Device|20 mm CRE balloon|Endoscopic balloon that is used to dilate pylorus
16398210|NCT05085951|Diagnostic Test|OGD|OGD (No dilatation)
16398211|NCT05085938|Procedure|gonadal vein embolization|Standard coil embolization of gonadal veins.
16398212|NCT05085938|Procedure|endoscopic gonadal vein resection|Standard endoscopic resection of gonadal veins.
16398213|NCT05085925|Behavioral|Cognitive behavioral mindfulness intervention|The group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5
16398214|NCT05085925|Behavioral|Cognitive behavioral mindfulness intervention after 3-month wait list|Wait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions.
16398215|NCT05085912|Procedure|Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation|Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
16398216|NCT05085912|Procedure|Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation|Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
16398217|NCT05085912|Procedure|Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion|Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
16398218|NCT05085886|Behavioral|DepCare|Primary Care Provider (1) One-time presentation or video with education and motivational messaging around collaborative care, functionality of the DepCare patient tool and optimal management of depression and comorbid anxiety (2) Quality improvement/ implementation team meetings on optimizing mental health treatment in primary care and DepCare (i.e., multi-level, multi-component intervention) implementation (3) Automatically-generated decisional support on individual patient treatment preferences (i.e., for every patient who receives the DepCare patient tool) Patient: Tool comprised of enhanced depression and anxiety screening (includes option for voice-over questions, point-and-click responses), and for those who screen positive for depressive symptoms (with or without comorbid anxiety), diagnosis recognition support, psycho-education, videos promoting patient engagement in treatment, and personalized medication selection support.
16398219|NCT05085886|Behavioral|Enhanced Usual Care|Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization
16398222|NCT05085860|Behavioral|Moderate-intensity continuous training (MICT)|Participants will engage in exercise and record AF symptoms prospectively over 7 days
16398223|NCT05085860|Behavioral|High-intensity interval training (HIIT)|Participants will engage in exercise and record AF symptoms prospectively over 7 days
16398224|NCT05085847|Other|Mindfulness meditation training|Mindfulness-based intervention encompasses different practices which intend to exercise awareness by using mindfulness meditation training moment by moment. Thus, practices such as mindful breathing, compassionate communication, loving-kindness, self-compassion, mindful listening, dealing with difficulties, the 3 step meditation, walking meditation, body scan with progressive relaxation, thoughts, emotions, gratitude, and sounds and breathing will be teaching to participants. Mindfulness training will be conduct by two instructors with more than 30 years' experience in meditation practices (Zen and Tibetan Buddhist approach to mind-training) and extensive mindfulness teaching and practices (> 5 years each) experiences.
16398225|NCT05085847|Other|Active control|Participants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation). Lesson topics include science.
16398226|NCT05085834|Drug|Zinc Gluconate|Zinc supplementation
16398227|NCT05085821|Device|HEART|In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
16398228|NCT05085821|Device|Placebo|In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
16398229|NCT05085808|Drug|Trazodone|Trazodone will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the trazodone arm.
16398230|NCT05085808|Drug|Quetiapine|Quetiapine will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the quetiapine arm.
16398231|NCT05085808|Drug|Placebo|Placebo will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the placebo arm.
16398232|NCT05085795|Device|Impulse Oscillometer|The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
16398233|NCT05085782|Drug|Propranolol Hydrochloride|6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
16398234|NCT05085782|Drug|Placebo|6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
16398235|NCT05085782|Behavioral|Reactivation procedure|Description/visualization of painful movements/activities
16398236|NCT05085782|Behavioral|Pain neuroscience education|In the form of 10 videos that participants will watch on their own time
16398237|NCT05085769|Procedure|Bariatric surgery|A procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.
16398238|NCT05085756|Behavioral|Puma|One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.
16398355|NCT05084768|Diagnostic Test|Donor-derived cell-free DNA|As mentioned previously
16398239|NCT05085743|Diagnostic Test|Deep convolutional neural networks analysis|using Deep convolutional neural networks to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation
16398241|NCT05085704|Device|Magnetic resonance imaging|Medical imaging technique used in radiology to form pictures of the anatomy.
16398242|NCT05085678|Device|Co'moon (online website to support women with AET)|"The tool contains three parts:
~e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven,
~serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management,
~a patient-reported-outcome questionnaire (PROMs), reported in the patient medical file.
~The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals ."
16398243|NCT05085665|Drug|Ivermectin|single dose, 150 ug/kg
16398244|NCT05085652|Procedure|spinal anesthesia induced hypotension in SARS-CoV-2 patients.|SARS-CoV-2 infection prognosis remains unclear during pregnancy. according to ESA, ASRA and WHO regional anesthesia was recommended to use for caesarian section procedures. But at the beginning of the pandemic Chen et al shared their retrospective analyses about regional anesthesia for caesarian section and they showed high spinal anesthesia induced hypotension in 14 patients of the 17 and also again Chen and Zahng et al made another study and this time they found 57,4% hypotension incidence. In our study we aimed to find if the spinal anesthesia safe procedure in the 249 patients and one center hospital.
16398245|NCT05085639|Biological|GLS-5130|GLS-5310 DNA plasmid vaccine
16398246|NCT05085639|Biological|Placebo|Placebo
16398247|NCT05085626|Drug|fluzoparib+chidamide|Arms A will be treated with fluzoparib in combination with cedaramide
16398248|NCT05085626|Drug|fluzoparib+camrelizumab|Arms B will be treated with fluzoparib in combination with camrelizumab
16398249|NCT05085613|Behavioral|Corrective message framing and humor|The main content of the messages will be the same. Experimental conditions (arms 2-4) will additionally include consequent framing as a result of getting vaccinated (e.g. economic recovery for arm 2 and freedom for arm 3) and humor for arm 4. Participants will be randomized to view one of the four messages.
16398252|NCT05085587|Drug|Test|2 inhalations of Test and Reference product in each study period
16398253|NCT05085587|Drug|Reference|2 inhalations of Test and Reference product in each study period
16398254|NCT05085574|Drug|Famotidine|80 mg tablet, QID for 14 days
16398255|NCT05085574|Drug|Celecoxib|400 mg (initial dose), then 200 mg capsule, BID for 5 days
16398256|NCT05085574|Drug|Placebo|tablet, QID for 14 days; capsule, BID for 5 days
16398257|NCT05085561|Drug|REC-994|REC-994 200 mg tablets
16398258|NCT05085561|Drug|Placebo|Placebo Tablets
16398259|NCT05085548|Drug|ProAgio|ProAgio is administered to study participants by intravenous injections once every 14 days.
16398262|NCT05085509|Procedure|US guidance and MB staining|Ultrasound guidance and methylene blue staining
16398263|NCT05085496|Biological|Atezolizumab|Given IV
16398264|NCT05085496|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16398265|NCT05085483|Dietary Supplement|Nutritional Ketogenic Supplement|This trial has 5 steps: (1) a 4-week run-in baseline; (2) a 4-week intervention phase to either active or placebo (3) a 4-week phase of washout; (4) the cross-over to the second 4-week active or placebo phase; (5) a 4-week follow-up.
16398266|NCT05085483|Dietary Supplement|Isocaloric placebo supplement|Isocaloric placebo supplement
16398267|NCT05085470|Biological|Schistosoma mansoni infection|20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain
16398268|NCT05085470|Biological|Placebo mock infection|Placebo mock infection with water
16398269|NCT05085457|Diagnostic Test|ExPreS Protocol|Prof, aqui explicamos o que é o ExPreS????? Já que ele fala para não repetir informação
16398270|NCT05085444|Biological|Assigned Interventions CD19/BCMA CAR T-cells|Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
16398271|NCT05085431|Biological|Assigned Interventions CD19/BCMA CAR T-cells|Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
16398272|NCT05085418|Biological|Assigned Interventions CD19/BCMA CAR T-cells|Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
16398273|NCT05085405|Behavioral|Clinician notification|"An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.
~In this arm, patients receive no additional interventions beyond that provided during treatment as usual."
16398567|NCT04994717|Drug|Low-intensity chemotherapy regimen|Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
16398274|NCT05085405|Behavioral|Clinician Notification with Information Relay|"An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will also provide education on medication changes to the patient upon request by the clinician.
~In this arm, patients receive no additional interventions beyond that provided during treatment as usual."
16398275|NCT05085405|Behavioral|Clinician Notification:|"An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.
~Patient Activation:
~An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk."
16398276|NCT05085405|Behavioral|Clinician Notification with Information Relay|"An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will also provide education on medication changes to the patient upon request by the clinician.
~Patient Activation:
~An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk."
16398278|NCT05085379|Device|Ossiview|Imaging of the ear using Optical Coherence Tomography
16398281|NCT05085353|Procedure|non-obstetric acute general surgical disease|non-obstetric acute general surgical disease
16398282|NCT05085340|Drug|Intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine|IPTi will be administered as full therapeutic courses of SP alongside routine EPI immunisations at defined intervals corresponding to vaccination schedules - usually at 10 weeks, 14 weeks, and 9 months of age - to infants living in project districts. Additional doses of IPTi will be administered at 6, 12, and 15 or 18 months of age, coinciding with vitamin A administration and measles booster immunisation. The number of doses of IPTi a child will receive will depend of the EPI schedule in the country, with a maximum of six doses in the first two years of life.
16398283|NCT05085327|Drug|ChapStick Lip Moisturizer Original|Sunscreen lip balm.
16398284|NCT05085327|Drug|ChapStick Lip Moisturizer Mint Flavour|Sunscreen lip balm.
16398285|NCT05085327|Drug|ChapStick Lip Moisturizer Black Cherry Flavour|Sunscreen lip balm.
16398286|NCT05085327|Drug|SPF Standard Sunscreen|SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)
16398289|NCT05085301|Diagnostic Test|Rapid diagnostic test|The performance of three index tests and two comparator tests will be compared to reference tests and gold standard microscopy.
16398292|NCT05085275|Drug|Ferric Citrate 1 GM Oral Tablet [AURYXIA]|All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
16398293|NCT05085275|Drug|Placebo|All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
16398294|NCT05085262|Diagnostic Test|Bloodwork, Echocardiogram, PET/MRI|The study will use blood samples from COVID biobank at University Health Network. Samples will be collected at time of admission to ER in patients discharged after assessment and at three time points during admission in patients who are admitted for measurement of blood biomarkers. Echocardiography studies will be assessed for structural and functional abnormalities. All included patients will have prospective short-term follow-up (3-6 months) for assessment of clinical events and subclinical cardiovascular disease. 50 patients who had clinical cardiac MRI at our center within 5 years prior to COVID-19 (January 2015-January 2020) and have since tested positive for COVID-19 will be recruited for research cardiac MRI to compare changes between baseline (pre-COVID) and follow-up (post-COVID imaging). A subgroup of 50 patients will undergo cardiac PET/MRI at 1-3 months post COVID-19 diagnosis to evaluate for myocardial inflammation and other imaging markers of cardiac injury.
16398388|NCT05084508|Biological|13-valent pneumococcal conjugate vaccine|1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh
16398389|NCT05082779|Drug|CS0159|Tablets administered orally
16398295|NCT05085262|Diagnostic Test|Bloodwork, Echocardiogram, MRI|The study will involve use of blood samples from the COVID biobank at UHN (University Health Network) for measurement of blood biomarkers. Echocardiography Studies will be systematically assessed for structural and functional abnormalities. All included patients assessment of clinical events and subclinical cardiovascular disease.
16398296|NCT05085236|Procedure|Fu's subcutaneous needling (FSN)|physician will use a disposable Fu's subcutaneous needling (FSN) to penetrate the subject's skin in the middle from elbow lateral epicondyle to radial styloid process. Then physician will push forward the needle parallel to the skin surface. the physician will sway the needle 100 times in a minute. After procedure of swaying needle, the physician will instruct subject to do several movements, and each movement will perform 10 seconds and rest 10 seconds for 3 repetitions. The movements are active isometric elbow flexion, active isometric shoulder internal rotation, passive shoulder external and internal rotation. After above re-perfusion approach of muscles, the physician will take out the needle to finish the treatment.
16398297|NCT05085236|Procedure|Rehabilitation|Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.
16398300|NCT05085210|Device|transcranial random noise stimulation (tRNS)|noninvasive current stimulation for 20 - 30 minutes stimulation on visual cortex (electrodes on surface of scalp, positioned O1 / O2 on EEG cap). 1mA max amplitude noise stimulation, frequencies from 100 Hz - 640 Hz.
16398301|NCT05085210|Behavioral|Computer Based Visual Training|Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center of screen during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.
16398302|NCT05085210|Device|Sham stimulation|20-30 minutes sham stimulation on visual cortex. Participants receive identical setup to real stimulation. The device provides a short ramp on period to simulate the feeling of real stimulation at the start but no current is delivered otherwise.
16398311|NCT05085184|Drug|administration of UI018|Test
16398312|NCT05085184|Drug|co-administration of UIC201806 and UIC201602|Reference
16398313|NCT05085171|Other|Enhanced care package|The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections
16398314|NCT05085145|Biological|Coronavirus vaccine|Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
16398315|NCT05085132|Behavioral|MindFi app: Standard content|Digital wellness training in this study will be delivered via the MindFi app, designed by Jaedye Labs. Content includes learning, assesesment, and practice tracks A core component of the exercises in this app is mindfulness training; however, the app also incorporates other exercises drawn from positive psychology such as journaling and diaphragmatic breathing. The app goes beyond traditional guided meditation through content that reinforces the principles and attitudes taught during in-person training, and also seeks to maximize user experience by using interactive tasks and progress charts.
16398316|NCT05085132|Behavioral|Mindfi app: Standard content without practice|In this condition, participants will receive a version of the MindFi app that does NOT contain the practice tracks, only the learning and assessment tracks.
16398317|NCT05085119|Procedure|Stepwise modifications of FiO2|FiO2 will be increased stepwise from 30 to 100% (40, 60 and 80%), and then decreased with the same FiO2 reverse steps.
16398318|NCT05085106|Drug|Felbinac trometamol eye drop|Felbinac trometamol eye drop: 0.025%、0.05%、0.1%、0.2%、0.3%, 1 drop will be instilled as instructed over one day in single-dose study; 0.1%, 0.2%, 1 drop per time, four times each day and for seven days totally in multiple-dose study.
16398319|NCT05085106|Drug|Placebo eye drop|Placebo eye drop: 0.0%, 1 drop will be instilled as instructed over one day in single-dose study; 0.0%, 1 drop per time, four times each day and for seven days totally in multiple-dose study.
16398320|NCT05085093|Biological|HPV vaccine|Patients choose to be vaccinated or not to be vaccinated with HPV vaccine according to their own wishes
16398321|NCT05085067|Other|auto-crossed-linked hyaluronic acid gel|infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
16398322|NCT05085054|Drug|Osimertinib Mesylate|Participants will receive targeted therapy followed by salvage surgery
16398324|NCT05085028|Drug|Pembrolizumab 25 MG/ML [Keytruda]|Pembrolizumab to be given at 400mg intravenous over 5 different frequencies
16398390|NCT05082324|Other|Adapted physical activity|Patient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week
16398325|NCT05085015|Other|Functional Exercise Training Group|"Training will start with Stretching Training and end with stretching training. Stretching exercises targeting actively applied shoulder girdle, chest, neck, trunk, hip, front and back leg and ankle muscle groups will be given. Afterwards, it will be continued with Aerobic Exercise Training. The training will be given on the treadmill Treadmill Technogym. Afterwards, it will be continued with Strengthening Training. Strength training will consist of a strengthening program that includes the lower extremity, upper extremity, trunk and core region. Elastic bands will be used in the training. Then, balance training will be given at the end."
16398326|NCT05085015|Other|Home Exercise Training Group|Training will start with Stretching Training and end with stretching training. Stretching exercises targeting actively applied shoulder girdle, chest, neck, trunk, hip, front and back leg and ankle muscle groups will be given. Afterwards, it will be continued with Aerobic Exercise Training. They will walk at least 30 minutes, 3 days a week for 8 weeks at outdoor. Afterwards, it will be continued with Strengthening Training. Strength training will consist of a strengthening program that includes the lower extremity, upper extremity, trunk and core region. Elastic bands will be used in the training. Then, balance training will be given at the end.
16398327|NCT05085002|Drug|Lerociclib + Letrozole or Fulvestrant|All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
16398328|NCT05084989|Biological|Recombinant two-component COVID-19 vaccine (CHO cell)|Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administration: Intramuscular (IM) injection
16398329|NCT05084989|Biological|Placebo|Before reconstitution: Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: Not Applicable; Does Volume: 0.5ml/dose; Routine of administration: IM injection;
16398330|NCT05084976|Behavioral|COVID 19 vaccine counseling|After surveys are completed, pulmonary provider (nurse practitioner or physician) will provide counseling via phone or in person about the COVID 19 vaccine. Safety, efficacy and side effects will be reviewed.
16398331|NCT05084963|Drug|IRL201104|lyophilised powder for reconstitution for IV dosing
16398332|NCT05084963|Drug|Placebo|Matching placebo for IRL201104
16398333|NCT05084937|Other|CeliCAT form|Systematic summary to support transition
16398334|NCT05084924|Device|Cross-frequency transcranial alternating current stimulation via the NeuroConn Direct Current Stimulator Plus|Stimulation will be delivered via the NeuroConn Direct Current Stimulator Plus, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research.
16398337|NCT05084898|Other|Far-UVC light as an additional method of disinfection|Far-UVC light is a form of ultraviolet light with an extremely short wavelength (207-222 nm)
16398338|NCT05084898|Other|Placebo fluorescent light|"Inactive fluorescent light (no additional disinfection)"
16398339|NCT05084885|Other|Online therapy|Standard counseling provided over the internet.
16398340|NCT05084872|Drug|Hydroxychloroquine|Patients will be treated by hydroxychloroquine at a dose of 6 to 6.5mg/kg/day during 12 month
16398341|NCT05084859|Drug|SM08502|SM08502 to be administered orally.
16398342|NCT05084859|Drug|Abiraterone|Abiraterone to be administered orally.
16398343|NCT05084859|Drug|Prednisone|Prednisone to be administered orally.
16398344|NCT05084859|Drug|Docetaxel|Docetaxel to be administered intravenously.
16398345|NCT05084859|Drug|FOLFIRI Protocol|FOLFIRI Protocol to be administered intravenously.
16398346|NCT05084859|Drug|Panitumumab|Panitumumab to be administered intravenously.
16398350|NCT05084820|Combination Product|Action observation treatment|Participants will watch 5 videos of motor tasks; each video is of 30 sec and watch for 4 times (i.e. for 2 minutes). Then patient will execute the motor act, soon after the observation with an affected limb for 2 minutes, with total rest time of 5 minutes for this treatment. Conventional treatment of muscle stretching, strengthening and ROM exercises will be given for 15 minutes including rest. Total treatment time is 40 minutes.
16398351|NCT05084820|Combination Product|conventional treatment|conventional treatment of 40 minutes in total will be performed including Stretching (for 8-10 sec with set of 5 repetitions/ session on each side for 3 minutes total with rest), strengthening (weighted bicep curls, side arm raise and open arm movement exercises with set of 5 repetitions/ session for 9 minutes total with rest), Range of motion exercises active and passive with set of 5 repetitions/ session for 3 minutes total with rest and gripping,reaching, grasping exercises (on each side for total 25 minutes including rest) with assistance of physiotherapist
16398352|NCT05084807|Other|Endoscopy|"A dyspepsia test will be performed to avoid selection bias. In subjects strictly asymptomatic, a blood analysis will be proposed.
~Subjects who present strictly normal laboratory tests (including celiac serology and negative H Pylori tests) and no genetic risk of celiac disease will be invited to perform an upper gastrointestinal endoscopy.
~During gastroscopy, samples of normal mucosa will be taken for histological and lymphocyte subpopulations analysis. The percentage of lymphocyte subpopulations will be assessed by flow cytometry.
~To compare whether there are differences between the lymphocyte subpopulations related to the age and sex of the healthy individuals, a student's t test, ANOVA or the corresponding non-parametric test will be used. The values will be expressed according to: mean +/- 2DS or median and interquartile range."
16398353|NCT05084794|Procedure|Internal fixation|Fixation of posterior malleolus with either plate or screws.
16398354|NCT05084781|Procedure|Coblation Debridement (FLOW90)|bipolar radiofrequency energy
16398356|NCT05084742|Device|Biodentine™|"Biodentine™ is a bioactive dentin substitute from the  Active Biosilicate Technology®  innovation.
~Study participants were treated between 01mar2016 and 30Sept2020 with an endodontic microsurgery using Biodentine™ used in its endodontic indications, i.e., root end-filling, external or internal root resorption repair, root and furcation perforation repair, and apexification."
16398357|NCT05084729|Device|Imagio OA/US|Imagio optoacoustic
16398358|NCT05084716|Behavioral|Enhanced PrEP provision|The intervention will train health care providers to facilitate workshops at outreach events where attendees can learn basic facts about PrEP and be taught skills about how to advocate for PrEP in their community. Healthcare facility staff will encourage PrEP initiators to select an adherence supporter. Check-in reminder calls will be conducted systematically with PrEP users.
16398359|NCT05084703|Other|Functional tests|"Symmetry indices between the two limbs obtained thanks to the scores of the functional tests : Y balance test
~Muscle endurance index obtained from functional test scores : Closed Kinetic Chain Upper Extremitie Stability test"
16398360|NCT05084690|Other|Unilateral resistance training|Unilateral resistance training of the elbow flexors
16398361|NCT05084690|Other|Illusionary mirror visual feedback|Modified Ramachandran's mirror box
16398362|NCT05084677|Combination Product|Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy|Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) concurrent with chemoradiotherapy; 6 cycles of Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) after chemoradiotherapy; Toripalimab 240mg intravenously(IV) every 6 weeks (Q6W) thereafter until the whole treatment period reached one year since the beginning.
16398365|NCT05084651|Drug|Ganaplacide|Treatment A/Period 1: 400 mg (4 x 100 mg tablets) at Hour 0 on Day 1 Treatment B/Period 2: 400 mg (4 x 100 mg tablets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.
16398366|NCT05084651|Combination Product|Lumefantrine|Treatment A/Period 1: 480 mg (2 x 240 mg sachets) at Hour 0 on Day 1 Treatment B/Period 2: 480 mg (2 x 240 mg sachets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.
16398367|NCT05084651|Drug|Itraconazole|200 mg (20 mL of 10 mg/mL oral solution) q.d. on Days 1 to 18
16398368|NCT05084638|Drug|Ofatumumab|20mg subcutaneous injection
16398369|NCT05084625|Other|Digitized support|Access to information about the disease, treatment, side effects and self-care
16398370|NCT05084612|Device|standard LMA insertion|"Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete
~the laryngeal mask will be inserted with using the standard method described by Brain; after lubrication of the posterior aspect of the partially deflated mask, the patient's head will be positioned with head extended at the atlanto-axial joint and flexed at the neck with non-dominant hand. The LMA will be held like a pen and index finger will be placed at the junction of LMA tube and cuff. Index finger will be used to press the LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of the hypopharynx. LMA will then be held with non-dominant hand and index finger will be removed."
16398371|NCT05084612|Device|New technique LMA insertion|Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete LMA will be inserted by a two Person Insertion with lateral rotation Technique; after lubrication of the posterior aspect of the partially deflated mask, the assistant will achieve jaw thrust and mouth opening then LMA will be inserted by the anaesthiologist. LMA will be inserted by holding the mask by index, middle finger and thumb; after insertion of the entire cuff inside the mouth, the LMA will be rotated anticlockwise through 90° (the inner surface of LMA will be directed medially towards the mouth cavity) and advanced through the side of the tongue until resistance felt, then turned back in the hypopharynx.
16398372|NCT05084599|Drug|Metaraminol 2.7μg/kg/min|After spinal anesthesia, the patient was placed in a supine position until the fetus was delivered, and metaraminol was given at an initial rate of 2.7μg/kg/min throughout the process.
16398373|NCT05084599|Drug|Metaraminol 2μg/kg/min|After spinal anesthesia, the patient was placed in left-tilt position until the fetus was delivered, and metaraminol was given at an initial rate of 2μg/kg/min throughout the process.
16398374|NCT05084586|Drug|Intravesical Solution|After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 150 ml saline was continuously instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
16398375|NCT05084586|Drug|Intravesical Solution|After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 50 ml saline was instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
16398376|NCT05084573|Drug|Liposomal bupivacaine|Single bolus injection 10mL 1.33% LB
16398377|NCT05084573|Drug|Standard bupivacaine|Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
16398378|NCT05084560|Drug|AWZ1066S|Candidate drug to treat lymphatic filariasis by targeting Wolbachia endosymbiont
16398379|NCT05084560|Drug|Placebo|Placebo
16398380|NCT05084547|Other|No intervention|No intervention
16398381|NCT05084508|Biological|Investigational varicella vaccine low potency|1 dose of a low-potency investigational varicella vaccine administered subcutaneously in the upper arm
16398382|NCT05084508|Biological|Investigational varicella vaccine medium potency|1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm
16398383|NCT05084508|Biological|Investigational varicella vaccine high potency|1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm
16398384|NCT05084508|Biological|Marketed varicella vaccine Lot 1|1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm
16398385|NCT05084508|Biological|Marketed varicella vaccine Lot 2|1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm
16398386|NCT05084508|Biological|Measles, mumps, and rubella vaccine|1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm
16398387|NCT05084508|Biological|Hepatitis A vaccine|1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh
16398456|NCT05048446|Other|observational|Non intervention
16398392|NCT05079672|Drug|Dexmedetomidine|Dexmedetomidine injectable solution, at the rate of 0,3μg/ kg/h, will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass.
16398393|NCT05079672|Drug|0,9% Saline|Saline 0,9% will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by- pass.
16398395|NCT05078190|Other|Social Determinants of Health|The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
16398396|NCT05076708|Other|IQOS|All participants switch from cigarette smoking to IQOS use for a 14-day phase.
16398397|NCT05075252|Procedure|laparoscopic lavage|This study aims to investigate the impact of laparoscopic lavage on the incidence of postoperative abscesses stratifying patients on the grade of appendicitis and peritoneal contamination.
16398398|NCT05074823|Drug|Ketamine 0.1 mg|Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg
16398399|NCT05074823|Drug|Ketamine 0.2 mg|will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg
16398400|NCT05074823|Drug|Ketamine 0.3 mg|will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg
16398401|NCT05074810|Drug|VS-6766 and sotorasib|The RP2D of VS-6766 + sotorasib determined in Part A will be used in Part B dose expansion
16398402|NCT05074771|Device|ARC intellicare|ARC is a system that allows home motor and respiratory rehabilitation. The system includes 5 inertial measurement units for limbs and neck, a tablet with a dedicated app installed, to acquire and monitor the exercises performed by the patient in his/her daily rehab activity. Sensors and tablet can be charged on the base station. ARC allows the therapist to tailor the individual rehab project, with the support of a monitoring dashboard. The artificial intelligence engine analyses data coming from sensors positioned on the limbs, providing real-time feedback to the patient on the correct number of repetitions performed for each exercise. ARC allows therapists to create new exercises and/or select exercises from the ARC library to customize treatment (including tutorials and tips) based on condition-specific validated protocols and best practice. Patients can safely perform home rehabilitation sessions by wearing sensors and following video tutorials and tips from the ARC library.
16398403|NCT05074667|Device|Continuous Glucose Monitor|Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care
16398404|NCT05074667|Other|Patient Reported Outcome Questionnaires|Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.
16398405|NCT05074459|Drug|Eptinezumab Mammalian Cell Line|Concentrate for solution for IV infusion
16398406|NCT05074459|Drug|Eptinezumab Yeast Cell Line|Concentrate for solution for IV infusion
16398408|NCT05074017|Device|3 nasopharyngeal swab|3 nasopharyngeal swabs to conduct 2 rapid antigen tests for SARS-CoV-2 and a RT-PCR
16398409|NCT05073432|Other|Experimental|Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis
16398410|NCT05072990|Drug|Chinese herb medicine|Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.
16398412|NCT05071976|Diagnostic Test|ICG-NIR angiography|Capture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video
16398413|NCT05071586|Device|Soterix 1x1 tDCS mini-CT Stimulator device|Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS mini-CT Stimulator device in the home setting under caregiver and remote investigator supervision and direction for three consecutive days. If at any time the child perceives discomfort while dosing to 1.5mA the investigators will adapt and modify the stimulation using a new pre-set activation code.
16398414|NCT05070286|Behavioral|Observational Study.|Semi-structured interviews.
16398415|NCT05069701|Diagnostic Test|SVV test|SVV test will be done with virtual reality glasses.
16398416|NCT05068206|Drug|AK105 injection|AK105 is programmed death 1（PD-1） monoclonal antibody
16398417|NCT05068206|Drug|Anlotinib hydrochloride capsule|Anlotinib is small molecule multi-target tyrosine kinase inhibitor.
16398418|NCT05068206|Drug|CapeOX|CapeOX is Capecitabine+Oxaliplatin. Capecitabine is a kind of fluorouracil drug, and Oxaliplatin is a kind of platinum anticancer drug.
16398419|NCT05068206|Drug|Bevacizumab|Bevacizumab is a recombinant human monoclonal antibody.
16398420|NCT05065008|Other|Cranberry juice|The responders and non-responders will drink 20-30 oz of (590-885 mL) 27% cranberry juice daily for 3 weeks.
16398421|NCT05065008|Other|Apple juice|The participants will drink apple juice with matching sugar content and calories for 3 weeks
16398422|NCT05063370|Drug|Levosimendan|Patients will receive Levosimendan infusion 12 hours before surgery in the ICU at a dose of 0.2 μg kg/min for the first hour and then reduced to 0.1 μg kg/ min to be continued in the operating room and then in the ICU (total infusion time of 24 hours).
16398423|NCT05063370|Drug|Standard Care|Patients will not receive Levosimendan and will receive standard care according to the institution protocol
16398425|NCT05061979|Drug|BAY1747846|Solution for intravenous (IV) injection, single dose
16398429|NCT05058846|Procedure|Biospecimen Collection|Undergo blood, tissue, and saliva collection
16398430|NCT05058846|Procedure|Magnetic Resonance Cholangiopancreatography|Undergo MRCP
16398431|NCT05058846|Procedure|Magnetic Resonance Imaging|Undergo MRI
16398432|NCT05058846|Procedure|Endoscopic ultrasound|Undergo endoscopic ultrasound
16398433|NCT05058846|Other|Questionnaires|Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire
16398434|NCT05058339|Other|Survey Administration|Complete survey
16398435|NCT05054491|Behavioral|Group Antenatal Care|Group ANC is an integrated approach that incorporates physical assessment, education and skill development, and peer support and takes a broader, more holistic, woman-centered approach to traditional antenatal care
16398436|NCT05054088|Device|T-Detect COVID test|• The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.
16398437|NCT05052996|Drug|ISL|Capsules administered orally without regard to food
16398438|NCT05052996|Drug|LEN|Tablets administered orally without regard to food
16398439|NCT05052996|Drug|B/F/TAF|Tablets administered orally without regard to food
16398440|NCT05052060|Other|Group A|19 patients will be treated with pelvic tilt exercises
16398441|NCT05052060|Other|Group B|19 patients will be treated with pelvic tilt exercises and facet joint manipulation.
16398442|NCT05051644|Behavioral|Steps 2 Change (S2C)|Participants assigned to S2C and health education control will be scheduled for 60-minute weekly group sessions held over four consecutive weeks in the outpatient OAT clinic. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain. Session 2 and 3 will introduce a progressive walking program with individual goals and weekly step count benchmarks and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior.. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting in Session 2. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.
16398443|NCT05051644|Behavioral|Health Education|"The health education control will be matched for treatment exposure and complexity of treatment material. Topics for control sessions will be selected modules from the VA Healthy Living manual. Session 1 will focus on the module Be Involved in Your Healthcare which includes strategies to retain information from multiple healthcare visits and improve self-advocacy. Session 2 will utilize the Manage Stress module that will cover the definition of stress and negative health impact of chronic stress. Session 3 will use the Eat Wisely module that will discuss health conditions associated with poor diet and key recommendations to maintain a healthy diet. Session 4 will use the Be Safe module that discusses ways to prevent falls, self-harm, sexually transmitted diseases, and intimate partner violence. All of these modules are designed to provide information about improving health and self-management skills without explicitly discussing pain or setting goals for treatment."
16398444|NCT05051566|Drug|LY3502970|Administered orally.
16398445|NCT05051566|Drug|Esomeprazole|Administered orally.
16398446|NCT05051059|Other|Functional outcome|3D-motion analysis and strength assessment
16398447|NCT05051059|Other|Health related quality of life (HRQoL) assessment|Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)
16398450|NCT05050123|Behavioral|iPhone Google Cardboard virtual reality meditation/relaxation app|Virtual reality meditation/relaxation app that has 6 scenes of 360° visual imagery with soothing music. The patient can spend about 15 minutes exploring the app.
16398451|NCT05050123|Behavioral|Standard relaxation training|"15 minute sessions of guided imagery using Mayo Clinic Patient Education CD-ROM Relaxation for Your Mind and Body"
16398452|NCT05049369|Device|Polysomnography|Polysomnography is performed one time overnight
16398453|NCT05048992|Other|ELDOA method|group A will receive
16398454|NCT05048992|Other|Post-facilitation stretching|Group B will receive
16398455|NCT05048732|Drug|18F-FluorApoTrace|-The dose of 18F-FluorApoTrace to be given is 5 mCi
16398457|NCT05047770|Biological|HZ/su|2 doses of HZ/su vaccine administered intramuscularly, either sequentially (HZ/suSeq Group) or simultaneously (HZ/suCoAd Group) with the mRNA-1273 booster dose. The second dose of HZ/su is administered 8 weeks after the first dose of HZ/su vaccine.
16398458|NCT05047770|Combination Product|Flu D-QIV|1 dose of Flu D-QIV vaccine administered intramuscularly, either sequentially (FluD-QIVSeq Group) or simultaneously (FluD-QIVCoAd Group) with the mRNA-1273 booster dose.
16398459|NCT05047770|Biological|mRNA-1273|1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
16398460|NCT05046054|Device|transcutaneous electrical nerve stimulation|transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
16398461|NCT05046054|Device|Placebo transcutaneous electrical nerve stimulation|Placebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
16398465|NCT05039047|Other|Standard stroke acute care and rehabilitation|According to Swiss national guidelines and local protocols
16398476|NCT05034952|Drug|VX-548|Tablets for oral administration.
16398477|NCT05034952|Drug|HB/APAP|Capsules for oral administration.
16398478|NCT05034952|Drug|Placebo (matched to VX-548)|Placebo matched to VX-548 for oral administration.
16398479|NCT05034952|Drug|Placebo (matched to HB/APAP)|Placebo matched to HB/APAP for oral administration.
16398480|NCT05034835|Device|usual treatment with compression garments (CERECARE)|For 3 months, the pain will be assessed every week, tolerance and compliance with compression garments will also be monitored. Participants will be reviewed specifically at a follow-up consultation for the 6-month and 1-year study. Various assessments will be carried out during these visits : assessment of pain, range of motion, muscle strength, sensitivity test, assessment of anxiety, depression and even quality of life.
16398481|NCT05034835|Other|usual treatment without compression garments (CERECARE)|For 3 months, the pain will be assessed every week, tolerance and compliance with compression garments will also be monitored. Participants will be reviewed specifically at a follow-up consultation for the 6-month and 1-year study. Various assessments will be carried out during these visits : assessment of pain, range of motion, muscle strength, sensitivity test, assessment of anxiety, depression and even quality of life.
16398482|NCT05034614|Diagnostic Test|Papette brush collection|Cervical cell brush that gathers collects cervical cells during Pap smear collection
16398483|NCT05034614|Diagnostic Test|Spatula/cytology brush collection|Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
16398484|NCT05033886|Drug|fezolinetant|oral
16398485|NCT05033886|Drug|placebo|oral
16398486|NCT05033600|Device|S.C.I.O.|The devices read, emit and entrain Electromagnetic waves of the body.
16398566|NCT04994717|Drug|Blinatumomab|Continuous intravenous (cIV) infusion
16398487|NCT05030792|Other|Attention-restorative therapy (ART)-based virtual reality (VR)|The ART-based VR intervention will be provided using an Oculus Go™ which is a commercially available, all-in-one VR headset with a handheld controller.
16398490|NCT05030207|Diagnostic Test|Real-time Gated 4DCT|Real-time gated four-dimensional cone beam computed tomography (4DCT) will be conducted at the simulation session. The Real-Time Gated 4DCT will be conducted while the patient moves through the rotating X-ray imager. This method detects and then pauses the CT beam during irregular breathing events.
16398491|NCT05030207|Diagnostic Test|Conventional 4DCT|Four-dimensional computed tomography (4DCT), the standard of care for modern high-precision stereotactic ablative body radiotherapy (SABR), will be conducted at the simulation session. It will run continuously while the patient moves through the rotating X-ray imager.
16398492|NCT05029427|Other|High molecular weight β-glucan oat cookies|Two cookies that contains 4g beta glucan made from oats will be consumed per day.
16398493|NCT05029427|Other|Control wheat based cookies|Two cookies that made from cream of wheat without beta glucan will be consumed per day.
16398494|NCT05028569|Drug|BOTOX|Intramuscular Injection
16398495|NCT05028569|Drug|Placebo|Intramuscular Injection
16398496|NCT05028257|Biological|COVID-19 Vaccines|Pursuit of vaccination in case of anaphylactic reaction
16398510|NCT05024045|Drug|LOXO-338|Oral
16398511|NCT05024045|Drug|Pirtobrutinib|Oral
16398512|NCT05022121|Behavioral|Supported Biopsychosocial Self-Management (SBSM)|Participants receive training and instruction in skills to engage in healthy physical, psychological, and social self-management behaviors. This will be accomplished through 6-12 sessions with a trained chiropractor or physical therapist. Patients will receive training and instruction in exercises targeting posture, strength, stabilization, and mobility based on their individual needs. They will learn psychological strategies including problem solving and cognitive restructuring to address unhelpful thoughts and emotions. Social strategies include pleasant activity planning with a social focus, and communication techniques for navigating relationships to garner support for self-sufficiency. Other elements include providing key evidence based information about BRLP and spinal manipulation therapies (SMT). SMT will include manipulation, mobilization and soft-tissue treatment. Other intervention elements include enablement, persuasion, and resources and materials to support the patient.
16398513|NCT05022121|Drug|Medical Care|Medical care will be comprised of primarily medication management, which is a standard first-line approach for back-related leg pain in primary care. Choice of medications is informed by the current evidence and the American College of Physicians guidelines on noninvasive treatment for LBP which balances evidence for risks and benefits when making recommendations. Decisions regarding medication selection will be made collaboratively between the study provider and patient after a discussion of risk/benefit profiles and patient preferences, including prior response. Study providers licensed to prescribe FDA-approved medications will call-in the prescription for the medication of choice to the participant's preferred pharmacy, as is typical in clinical practice.
16398514|NCT05018221|Drug|Vitamin K1|Vitamin K1 capsule (10mg) to be administered 3 times per week following the subject's hemodialysis session.
16398515|NCT05018221|Drug|Magnesium citrate|Magnesium Citrate tablet (150mg) to be administered 3 times per per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session.
16398516|NCT05018221|Drug|Sodium Thiosulfate|Sodium Thiosulfate injection (25g/100ml) to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
16398517|NCT05018221|Device|High Flux Dialyser|Hemodialysis using a high flux dialyser.
16398518|NCT05018221|Device|Medium Cut-off Dialyser|Hemodialysis using a medium cut-off dialyser.
16398519|NCT05018221|Drug|Placebo injection (normal saline)|Placebo to be administered intravenously 3 times per week, during the subject's last hour of hemodialysis.
16398520|NCT05018221|Drug|Placebo capsule (Vitamin K1)|Placebo to be administered 3 times per week following the subject's hemodialysis session.
16398521|NCT05018221|Drug|Placebo tablet (Magnesium citrate)|Placebo to be administered 3 times per day. On dialysis days, administration of the middle daily dose should occur following the subject's hemodialysis session.
16398524|NCT05016947|Drug|Venetoclax|Tablet, taken by mouth
16398525|NCT05016947|Drug|Dexamethasone|Taken orally
16398526|NCT05016947|Drug|Inotuzumab Ozogamicin|Intravenous infusion
16398527|NCT05016882|Drug|NNC0194 0499 50 mg/mL|Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months
16398528|NCT05016882|Drug|Placebo (NNC0194-0499)|Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months
16398529|NCT05016882|Drug|Semaglutide 3 mg/mL|Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months
16398530|NCT05016882|Drug|Semaglutide placebo|Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months
16398531|NCT05016882|Drug|NNC0174 0833 10 mg/mL|Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months
16398532|NCT05016882|Drug|NNC0174 0833 placebo|Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months
16398533|NCT05014204|Device|The Endogenex Device|The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.
16398534|NCT05013242|Drug|Zoladex|evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
16398535|NCT05013242|Drug|Visanne|valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
16398537|NCT05011396|Drug|PH94B Nasal Spray|Nasal spray delivered 20 minutes before the public speaking stressor
16398538|NCT05011396|Drug|Placebo Nasal Spray|Nasal spray delivered 20 minutes before the public speaking stressor
16398543|NCT05005026|Other|VR Game 1|"Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
~Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart."
16398544|NCT05005026|Other|VR Game 2|"Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
~Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart."
16398548|NCT05003804|Biological|STMC-103H|STMC-103H is a live biotherapeutic product (LBP) containing a consortium of intestinal bacteria
16398549|NCT05003804|Biological|Placebo|Powder containing excipients found in STMC-103H: magnesium stearate, mannitol and silicon dioxide.
16398550|NCT05001880|Biological|Atezolizumab|Given IV
16398551|NCT05001880|Biological|Bevacizumab|Given IV
16398552|NCT05001880|Drug|Carboplatin|Given IV
16398553|NCT05001880|Procedure|Cytoreductive Surgery|Undergo surgery
16398554|NCT05001880|Drug|Hyperthermic Intraperitoneal Chemotherapy|Undergo HIPEC
16398555|NCT05001880|Drug|Pemetrexed|Given IV
16398556|NCT05001256|Other|questionnaire study|Participants will be surveyed through face-to-face interviews.
16398557|NCT05001139|Device|Relizema ecofoam|DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration
16398558|NCT04999384|Drug|AN4005-dose level 0|50mg BID
16398559|NCT04999384|Drug|AN4005-dose level 1|100mg BID
16398560|NCT04999384|Drug|AN4005-dose level 2|200mg BID
16398561|NCT04999384|Drug|AN4005-dose level 3|400mg BID
16398562|NCT04999384|Drug|AN4005-dose level 4|600mg BID
16398563|NCT04999384|Drug|AN4005-food effect|Dose to be determined upon the MTD determination
16398564|NCT04998747|Drug|AMG 701|AMG 701 will be administered as SC or intravenous injection.
16398565|NCT04998747|Drug|AMG 701|AMG 701 will be administered as SC injection.
16398568|NCT04994717|Drug|SOC chemotherapy regimen|Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
16398569|NCT04994509|Drug|Oral Lenacapavir (LEN)|Tablets administered orally without regard to food
16398570|NCT04994509|Drug|Subcutaneous (SC) Lenacapavir (LEN)|Administered via SC injections
16398571|NCT04994509|Drug|F/TAF|Tablets administered orally
16398572|NCT04994509|Drug|F/TDF|Tablets administered orally
16398573|NCT04994509|Drug|Placebo SC LEN|Administered via SC injections
16398574|NCT04994509|Drug|PTM Oral LEN|Tablets administered orally
16398575|NCT04994509|Drug|PTM F/TAF|Tablets administered orally
16398576|NCT04994509|Drug|PTM F/TDF|Tablets administered orally
16398577|NCT04993898|Other|Plyometric training with warm up and cool down|These Include Squat to Squat Jump, Lunge to Plyo Lunge, Step Jack to Star Jumps, Plank to Plyo Spider Lunge, Plank to Frogger Frequency = 2 days per week for 2 weeks and then 4 days per week after 2nd week to 4th week Intensity =500 jumps Time = 30 min
16398578|NCT04993898|Other|Conventional training with warm up & cool down|These include Squats, Single leg squat, Cork hip lift, Press ups, Normal warm-up time 15 min before game.
16398579|NCT04988802|Dietary Supplement|Prenatal Nutrients Solgar|Patients will take dietary supplement Prenatal Nutrients from Solgar
16398580|NCT04988802|Other|Placebo|Placebo capsules based on starch.
16398584|NCT04982731|Other|Positive Assurance|"Positive assurance is a low-cost, non-pharmacological strategy commonly used by specialty clinics to manage anxiety in individuals with mTBI. Positive assurance is comprised of words of affirmation given to individuals with a medical condition by a healthcare provider that are centered on hope and positive recovery expectations (i.e., You will recover, This can be treated)."
16398585|NCT04980872|Drug|Miransertib|Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
16398588|NCT04976777|Drug|Updated Dexamethasone Posterior Segment Drug Delivery System|Intravitreal Administration
16398589|NCT04976777|Drug|Approved Dexamethasone Posterior Segment Drug Delivery System|Intravitreal administration
16398590|NCT04976595|Drug|Natesto|Nasal gel containing testosterone 11 mg/dose (5.5 mg/nostril) three times daily.
16398591|NCT04975672|Other|Myofuncional Therapy|Group 1, with myofunctional therapy and SN1 functional orthopedic appliances The participant underwent a myofunctional therapy session every month, for 9 months. In this group, a series of procedures and techniques are carried out to create and mechanize muscular and orofacial patterns at rest and in function, eliminate habits, correct muscular imbalance, improve the aesthetics of the patient and normalize the functions of the stomatognathic system. The myofunctional therapy performed will be by an expert speech therapist
16398592|NCT04974476|Other|HIIT Exercise Training|The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.
16398593|NCT04974099|Device|RoadMAB|The RoadMAB Dashboard is a real-time decision support system that incorporates PK model-informed Bayesian estimation to provide precision dosing at the point of care.
16398594|NCT04971122|Other|Trendeleburg -5 degree,-10 degree,-15 degree|Use a -5 or -10 or -15 degree trendelenburg position
16398595|NCT04970290|Device|Definisse threads free floating and definisse threads double needle|Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30
16398596|NCT04962230|Drug|PF-07321332/ritonavir|PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1
16398597|NCT04962230|Drug|Carbamazepine|In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.
16398598|NCT04962230|Drug|PF 07321332/ritonavir|In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.
16398599|NCT04962204|Behavioral|Virtual meeting between patients/physicians and caregiver|Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day
16398600|NCT04958941|Behavioral|Experimental: Intervention group|During 2 months participants will be able to asses their mood and practice in real time their emotional regulation skills with an ecological momentary interventions APP.
16398601|NCT04958941|Behavioral|Experimental: Assessment group|During 2 months participants will assess daily their mood with an ecological momentary assesment APP
16398644|NCT04927377|Behavioral|AI4DM|Those in the AI4DM intervention arm will receive weekly and bi-weekly calls for six months, access to home and online technology, diabetes-related multimedia educational content, a technology package including a voice-assistive device, wireless glucometer, and wrist-worn activity monitor
16398681|NCT04899843|Dietary Supplement|Placebo tablet 20 mg|Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids
16398682|NCT04899180|Drug|99mTc-PYP|Radioisotope used by SPECT/CT imaging
16398604|NCT04952532|Other|Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed Cognitive Remediation plus Bridging)|The proposed study aims to collect pilot data to test the feasibility and acceptability of adjunctive neuroplasticity-based cognitive remediation on key treatment targets. The intervention will be delivered via telehealth to a sample of 36 Veterans with MDD and a history of a suicide attempt. The intervention will be delivered in 20 90-min sessions (2x/week for 10 weeks). Pre-, post, and follow-up assessments will be conducted to assess changes in neurocognitive, clinical, social, and real-world functioning.
16398605|NCT04951050|Device|Rapamycin target eluting stent|Rapamycin target eluting stent
16398608|NCT04949841|Drug|Delgocitinib|Delgocitinib cream 20 mg/g
16398611|NCT04946955|Other|Application and website with or without promotion|Development of an application and a website to de-stigmatise mental health and support the user in seeking help
16398612|NCT04946721|Diagnostic Test|The standard care exam and biological specimens' collection|During each visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments or impression cytology of conjunctiva, blood or serum) will be collected.
16398613|NCT04943172|Device|Hancock-Jaffe bioprosthetic venous valve (VenoValve®)|Surgical implantation of the VenoValve device
16398614|NCT04942054|Drug|Part 1|Dose escalation cohort
16398615|NCT04942054|Drug|Part 2|Pharmacodyanamic (PD) dose exploration cohorts
16398616|NCT04942054|Drug|Part 3|Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort
16398617|NCT04941391|Device|AcQBlate® Force Sensing Ablation System|Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.
16398619|NCT04937231|Other|Aerobic exercises|"For Week 1 and 2 : Treadmill 3-5days/weeks
~Intensity:
~50-70 vo2 peak Or HRR 60-80% Duration of 10-20 minutes For Week 3 and 4; Cycle ergometer 3-5days/weeks
~Intensity:
~50-70 vo2 peak Or HRR 60-80% Duration of 30-40 minutes"
16398620|NCT04937231|Other|Resistance exercises|"For Week 1 and 2; 2 x 10 rep (unilateral leg press) 4x 12 reps (Bilateral leg press
~1 x 8 rep ( unilateral arm curls For Week 3 and 4; 1 x 10 reps Shoulder press
~1 x15 rep Bilateral knee extension
~1 x 10 reps Bilateral arm curls"
16398621|NCT04937231|Other|Combined training|For Week 1 and 2; Aerobic exercise on Treadmill along with dumbbell to perform upper limb exercises (biceps curls, side curls extensions, upright row, back fly) and used Thera band to perform lower limb exercises for 10-20 minutes For Week 3 and 4; Aerobic exercise on Treadmill along with dumbbell and Thera band to perform upper limb and lower limb exercises for 30-40 minutes
16398622|NCT04935775|Other|Untrained Touch|Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.
16398633|NCT04930549|Drug|Dapagliflozin 10Mg Tab|Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
16398634|NCT04930549|Drug|Placebo|Patients receive placebo tablets once a day during 12 weeks
16398635|NCT04930549|Procedure|impedance cardiography|impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
16398636|NCT04930549|Procedure|Applanation tonometry|Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
16398637|NCT04930549|Procedure|post-ischemic hyperemia of forearm|An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
16398638|NCT04930549|Procedure|haemodynamics parameters|haemodynamics parameters will be evaluated using automatic oscillometric recorder
16398639|NCT04928729|Other|Pursed Lip Breathing|PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.
16398640|NCT04928729|Other|Pursed Lip Breathing +DB|PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.
16398641|NCT04928729|Other|Conservative care|Participants will be having different dose as per tolerance 5 times daily.
16398642|NCT04928508|Drug|SHetA2|"SHetA2 orally in the form of 50 mg capsules. Four dose levels will be evaluated:
~5.4mg/kg 7.0mg/kg 9.0mg/kg 12mg/kg"
16398645|NCT04927377|Behavioral|Attention-control|Those in the Attention-control Group will receive telecoaching calls at the same frequency of the Intervention Group. Coaching calls will focus on general wellbeing, rather than diabetes-related topics. The Attention-control Group will serve as an untreated comparison group for the Intervention Group.
16398646|NCT04927182|Other|Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)|Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.
16398647|NCT04927182|Other|Moderate Exercise Training (Age Group 2; 31 to 45 years)|Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.
16398648|NCT04927182|Other|Moderate Exercise Training (Age Group 3; Above 45 years)|Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.
16398649|NCT04926415|Device|taVNS|A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 30 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used.
16398650|NCT04926415|Device|Sham taVNS|A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode.
16398651|NCT04924114|Drug|MK-6194|Subcutaneous injection
16398652|NCT04924114|Drug|MK-6194-matching placebo|Subcutaneous injection
16398653|NCT04922619|Device|tonotopy based fitting then default fitting|Cochlear implant with default fitting then tonotopy based fitting
16398654|NCT04922619|Device|default fitting then tonotopy based fitting|Cochlear implant with tonotopy based fitting then default fitting
16398655|NCT04916002|Drug|CMP-001|Subjects will receive CMP-001 10mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W). The first dose of CMP-001 may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of CMP-001, delivered on a weekly dosing schedule, must be completed before starting the Q3W CMP-001 dosing schedule.
16398656|NCT04916002|Drug|cemiplimab-rwlc|Subjects will receive cemiplimab-rwlc 350 mg IV over 30 minutes at W1D1 and Q3W thereafter.
16398659|NCT04914117|Drug|RC118 for injection|RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.
16398660|NCT04913805|Drug|Potassium Nitrate|Potassium Nitrate is the active intervention that may increase blood flow to exercising muscle
16398661|NCT04913805|Drug|Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside|Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside will be used as a combination intervention to both increase blood flow (KNO3) and mitochondrial function (PLC + NR)
16398662|NCT04913805|Other|Potassium Chloride|Active control
16398663|NCT04911517|Combination Product|long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations|long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer
16398664|NCT04904588|Drug|Busulfan|Given IV or PO pre-transplant as part of conditioning regimen
16398665|NCT04904588|Drug|Busulfan|Given IV pre-transplant as part of conditioning regimen
16398666|NCT04904588|Drug|Fludarabine|Given IV pre-transplant as part of conditioning regimen
16398667|NCT04904588|Radiation|Total-body irradiation|Administered pre-transplant as part of conditioning regimen
16398668|NCT04904588|Drug|Cyclophosphamide|Given IV pre-transplant as part of conditioning regimen
16398669|NCT04904588|Drug|Melphalan|Given IV pre-transplant as part of conditioning regimen
16398670|NCT04904588|Procedure|PBSC Hematopoietic Stem Cell Transplantation (HSCT)|Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
16398671|NCT04904588|Procedure|Bone Marrow Hematopoietic Stem Cell Transplantation|Bone marrow graft is infused from a mismatched unrelated donor on Day 0.
16398672|NCT04904588|Drug|Post-transplant Cyclophosphamide|Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
16398673|NCT04904588|Drug|Mesna|Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
16398674|NCT04904588|Drug|Tacrolimus|Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body weight (IBW) starting on Day +5 post-transplant with taper recommended at 90-100 days post HCT.
16398675|NCT04904588|Drug|Mycophenolate Mofetil|Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO from Day +5 to Day +35 post-transplant.
16398676|NCT04904588|Other|Patient-Reported Outcomes|Survey assessments will be administered to study participants pre- and post-transplant.
16398677|NCT04904354|Device|AcQBlate® Force Sensing Ablation System|Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.
16398680|NCT04899843|Dietary Supplement|Zinc sulphate tablet 20 mg|Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.
16398683|NCT04897945|Behavioral|Shared decision-making for diabetes prevention|Pharmacists and/or nurses will engage patients with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) recognized diabetes prevention program (DPP), and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
16398684|NCT04896970|Other|Concert|A musical show in a closed hall, lasting for about 2 hours, in respects of safety measure (masks, hydroalcoholic gel, etc…) with approximately 200 participants.
16398686|NCT04894123|Drug|Trifluridine/Tipiracil|"Trifluridine/tipiracil : 35 mg/m² orally twice a day from day 1 to day 5 every 14 days.
~If oxaliplatin is stopped or it is not indicated, trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days."
16398687|NCT04894123|Drug|Oxaliplatin|Oxaliplatin : 85 mg/m² intravenous at day 1 every 14 days.
16398691|NCT04884438|Behavioral|Psychological intervention for the promotion of gratitude|"A brief intervention protocol has been developed for the promotion of gratitude. The protocol is manualized and the content will be explained to each participant in the videoconference sessions, and a copy of the manual will be given (or sent) to the patients at the end of the therapy sessions.
~The structure and contents of the intervention are summarized below:
~Psychoeducation about gratitude and its effects on health (both physical and psychological).
~Gratitude towards life:
~Gratitude walk
~Three positive things
~Sharing gratitude
~Social gratitude:
~Daily thanks to others
~Gratitude letter
~Proof of gratitude
~Self-gratitude: this part includes an exercise aimed at fostering self-gratitude in three different areas:
~Gratitude for the things I do to take care of my physical health.
~Gratitude for what I do to take care of my mental health, my self-esteem and my personal development.
~Gratitude for what I do to take care of others."
16398692|NCT04879862|Combination Product|Epidural stimulation + Stand Training|Participants may use a standing apparatus or a less assistive device such as walker or cane. In case of upper limbs and trunk control insufficient for safely using the standing apparatus, participants will be placed on the treadmill, and a body weight support system. In this case, the level of body weight support will be continuously reduced as the individuals increase their ability to bear weight. A trainer positioned behind the participant will aid in pelvis and trunk stabilization. Trainer(s) positioned at the lower limb will provide manual facilitation for knee extension during standing. Manual facilitation at the trunk-pelvis and at the legs will be used only when needed.Participants will be encouraged to stand for as long as possible throughout the training session, with the goal to stand for 60 minutes with the least amount of assistance.
16398693|NCT04879862|Combination Product|Epidural stimulation + Step Training|Participants may be placed on the treadmill in an upright position and suspended in a harness. All trainers are careful to provide manual assistance only when needed. A trainer positioned behind the research participant will aid in pelvis and trunk stabilization, as well as appropriate weight shifting and hip rotation during the step cycle. Trainers positioned at each limb will provide manual assistance to promote knee extension and knee flexion and toe clearance. Research participants will step at various body weight load and speed. Research participants will take a break and rest at any time they feel the need to during the session. If independence is achieved during stepping, some training might be performed overground with appropriate assistive device and manual assistance to maintain participant safety. Participants will be encouraged to step for 60 minutes with the least amount of assistance. Seated or standing resting periods will occur when requested by the individuals
16398694|NCT04879862|Combination Product|Epidural stimulation + Bladder Capacity Training|We will initially conduct daily training for capacity in a supervised on-site lab setting. Optimal configurations will be used. The storage phase configuration will be used until the time for voiding/catheterization. The training procedure will be repeated for up to 8 hours daily on-site until three consecutive stable days of maintaining a consistent capacity values are achieved and deemed safe. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation (urodynamics and questionnaires). On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home-based training for bladder capacity.
16398695|NCT04879862|Combination Product|Epidural stimulation + Bladder Voiding Efficiency Training|We will conduct training for voiding efficiency in a supervised on-site lab setting while the participant continues his/her training for capacity. Voiding without catheterization will be attempted. The training procedure will be repeated for up to 8 hours on-site until three stable days of maintaining a consistent voiding efficiency are achieved and deemed safe. The participant will be sent home for one day to perform the stimulation at home. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation and questionnaires. On the return visit, if their storage/voiding outcomes remained stable over the 7 days, they will be able to start the home program integrating bladder training for capacity and voiding
16398696|NCT04878627|Drug|Cannabidiol|patients receive cannabidiol at various doses for 3 weeks
16398697|NCT04878627|Drug|Placebo|patients receive placebo for 3 weeks
16398698|NCT04876391|Drug|Spesolimab|Spesolimab
16398699|NCT04868682|Behavioral|Behavioral Education Intervention I|Manual-based education program provided in individual sessions.
16398700|NCT04868682|Behavioral|Behavioral Education Intervention II|Manual-based education program provided in individual sessions.
16398703|NCT04862143|Drug|Alpelisib|Alpelisib 300 mg daily up to 12 cycles of 28 days each
16398704|NCT04862143|Drug|fulvestrant|fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.
16398705|NCT04861558|Drug|5Fluorouracil|Injection of 250-850 mg/m2.
16398706|NCT04861558|Drug|Irinotecan|Injection of 360 mg/m2
16398707|NCT04861558|Drug|Oxaliplatin|Injection of 460 mg/m2
16398708|NCT04860830|Drug|BI 425809|BI 425809
16398709|NCT04860830|Drug|Placebo|Placebo
16398710|NCT04857372|Drug|IAG933|Capsule
16398711|NCT04855201|Drug|Bocidelpar|Oral
16398712|NCT04855201|Drug|Placebo|Oral
16398713|NCT04854967|Other|Rescind home oxygen order|A note will be entered in the medical record describing the participants randomization into the intervention group. The note will be signed by study staff and will accompany the discontinuation of the patient's home oxygen by a study clinician.
16398714|NCT04854967|Behavioral|Provider Education|A note will be entered in the medical record informing the patient's individual medical providers (i.e. primary care provider, pulmonologist) of their randomization into the intervention group. The note will include the evidence-base for oxygen use among patients with COPD.
16398715|NCT04854967|Behavioral|Patient Education|"The patient will receive a patient education page about discontinuation of home oxygen after recovery from a hospitalization that was developed by Consumer Reports in conjunction with the Choosing Wisely Campaign."
16398716|NCT04854967|Behavioral|Teach-to-goal inhaler training|Teach-to-goal (TTG) inhaler training is a patient-centered education strategy that has been shown to decrease inhaler misuse and decrease acute care utilization. The training is tailored to the patient and meets guideline recommendations for assessment and instruction of inhaler technique. The rounds of assessment and demonstration can be completed until acceptable skill level is attained and tailored to the specific medication prescribed.
16398717|NCT04854967|Behavioral|Pursed lip breathing|Pursed lip-breathing will be taught to the participants randomized to the intervention arm. This simple technique relieves breathlessness and has been shown to improve functional capacity in patients with COPD. Participants will be given an instructional handout to refer to after the visit.
16398719|NCT04850599|Drug|Carfilzomib|Given IV
16398720|NCT04850599|Biological|Isatuximab|Given IV
16398721|NCT04850599|Drug|Pomalidomide|Given PO
16398734|NCT04846127|Device|CanGaroo Envelope|Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.
16398740|NCT04839861|Behavioral|Mightier Family Games|Mightier Family Games includes five offline card games that can be played by two or more people. During card game play, one player wears the Mightier heart rate monitor, and can see a representation of their heart rate on a separate screen within the Mightier app. Each game includes elements that are tied to heart rate.
16398857|NCT04725071|Dietary Supplement|Boost High Protein|conventional supplement
16398741|NCT04839861|Behavioral|Mightier online gameplay|"Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a Mighty Band heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own."
16398742|NCT04838990|Other|EDSS|Neurological Exam - EDSS (Expanded Disability Status Scale)
16398743|NCT04838990|Other|Discussion of symptoms|Patients will be asked about their wellbeing
16398744|NCT04838197|Other|Questionnaires and Surveys|Quantitative questionnaires will measure and quantify the importance of the various factors (e.g., intensity of dependence, duration of care, health literacy, physical well-being, emotional well-being, social well-being, and financial well-being) that contribute to caregiver burden both preoperatively and postoperatively at 48 hours, 1 week, 2 weeks, and 1 month.
16398745|NCT04837235|Drug|Hemay005|oral
16398746|NCT04832724|Genetic|RGX-314|RGX-314 is a recombinant adeno-associated virus gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein
16398747|NCT04829981|Device|SAFEWATER systems for drinking water disinfection|A domestic water purification technology, consisting of a raw water storage tank, a pump, a filtration unit (2 cartridge filters), a UVC disinfection unit (UV lamp), a storage tank for drinking water (treated and safe water), and a distribution network inside the house for drinking water.
16398748|NCT04829981|Behavioral|Behaviour change interventions|Targeting behaviors around the use of the technology and water more generally. Behavioral interventions will be data-driven (i.e., dependent on the problems that arise) but are likely to include household and community-level activities.
16398749|NCT04827485|Other|Gluteal squeeze|During procedure, the doctor performing colonoscopy will ask for gluteal pressure. The technician will perform the maneuver, but the doctor will be blinded as the arms of the technician along with the patients behind are covered by a towel.
16398750|NCT04827485|Other|No squeeze|During procedure, the doctor performing colonoscopy will ask for gluteal pressure. The technician will not perform the maneuver, but the doctor will be blinded as the arms of the technician along with the patients behind are covered by a towel.
16398751|NCT04820647|Behavioral|KF-STRIDE|KF Stride works to improve identification (awareness) of personal character strengths and 2) express them in a socially appropriate way during a job interview
16398752|NCT04819386|Other|NEIVATECH active vision therapy sessions|NEIVATECH active vision therapy sessions will be 18 in total, will have an average duration of half an hour, and will be distributed in the following way: 5 sessions in the first week (Monday to Friday), 3 sessions in the second week (Monday, Wednesday, Friday) and 1 maintenance session in the following weeks (Wednesday). As participation in the study will last for three months, patients assigned to group A will have 10 active vision therapy sessions during the first month of treatment, 4 during the second month, and 4 during the third month.
16398753|NCT04819386|Other|Occlusion therapy|2 hours of conventional patching per day at home, every day for the 3 month duration of the study.
16398758|NCT04816721|Drug|EDP-938|Oral suspension
16398759|NCT04816721|Drug|Placebo|Placebo oral suspension to match EDP-938
16398760|NCT04815824|Behavioral|Exercise Mode|Stationary cycling or treadmill walking
16398764|NCT04810962|Drug|APP13007, 0.05%|APP13007 eye drop, 0.05%
16398765|NCT04810962|Drug|Matching Vehicle Placebo for APP13007, 0.05%|Matching vehicle placebo eye drop
16398766|NCT04809922|Device|cardiac wearable devices|"five cardiac wearable devices
~Apple Watch, Apple Inc., Model Number: A1977 / A1978
~Kardia Mobile, AliveCor Inc., AC-009/Kardia Mobile 6L, AliveCor Inc., AC-019
~Fitbit Sense, Fitbit, Inc, Model Number: FB512
~Samsung Galaxy Watch 3 Samsung Inc., Model Number: SM-R855F
~Withings Scanwatch, Withings SA, Model Number: HWA09 Used for recording of one single-lead ECG. The results will be 274 compared to a simultaneous 12-lead ECG, which is considered the gold standard for detecting AF. There is no comparator in this trial."
16398767|NCT04808947|Procedure|Local infiltration analgesia|Procedure: Local infiltration analgesia performed by surgeons.
16398768|NCT04808947|Procedure|Ultrasound-guided adductor canal block|Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.
16398770|NCT04800991|Device|Rhexium Onco Nutrition|"The research devices in this study are classified into subject mobile application and investigator web portal with no invasive action on the human body"
16398774|NCT04798924|Device|Subacute Training in the intact field|A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the intact field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
16398775|NCT04798924|Device|Subacute Training in the blind field|A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
16398776|NCT04798924|Device|Chronic Training in the blind field|After the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 6 months.
16398777|NCT04798274|Device|Transcranial Magnetic Stimulation|Single session of continuous theta burst stimulation (cTBS) (a form of repetitive transcranial magnetic stimulation). cTBS involves application of bursts of three pulses of TMS at 50 Hz, repeated at intervals of 200ms for a total of 600 pulses (200 bursts).
16398778|NCT04796337|Biological|sotatercept|sotatercept injection
16398779|NCT04796103|Procedure|Dextrose Prolotherapy|In the patients in the prolotherapy injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of 5% dextrose, 1 ml each, will be applied periarticularly. In addition, home exercise program will be given to this group.
16398780|NCT04796103|Procedure|Serum Physiological Group (placebo control group)|In the patients in serum physiological injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of saline will be applied periarticularly. In addition, home exercise program will be given to this group.
16398781|NCT04793646|Drug|N-acetylcysteine syrup|N-acetylcysteine syrup 600 mg (15 mL) twice a day for 3 months
16398782|NCT04793646|Drug|Placebo syrup|Placebo syrup 15 mL twice a day for 3 months
16398783|NCT04790851|Biological|COVAX+IIV4; COVAX+PPV23|1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
16398784|NCT04790851|Biological|COVAX only (1st and 2nd dose)|1st dose: COVAX only; 2nd dose: COVAX only
16398785|NCT04790851|Biological|IIV4 for the 1st dose and PPV23 for the 2nd dose|1st dose: IIV4 only; 2nd dose: PPV23 only
16398786|NCT04788303|Other|School meal, garden, education, and community workshops|"School meal: midday meal provided at intervention schools
~School garden: garden used to grow crops (which will be used to supplement the school meal in the full intervention schools)
~Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum
~Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH."
16398787|NCT04788303|Other|Garden, education, and community workshops|"School garden: garden used to grow crops
~Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum
~Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH."
16398788|NCT04788004|Other|Online survey|There are no interventions planned for this study. This is an observational study only.
16398789|NCT04787094|Other|Yoga|Yoga
16398790|NCT04787094|Other|Spinal Stabilization Exercise|Spinal Stabilization Exercise
16398793|NCT04777721|Biological|BCG Danish|BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
16398796|NCT04775550|Drug|Daratumumab|Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
16398797|NCT04775550|Drug|Bortezomib|Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
16398798|NCT04775550|Drug|Lenalidomide|Oral, dosage per protocol, days 1-21 per cycle
16398799|NCT04775550|Drug|Dexamethasone|Oral, dosage per protocol, dose days vary per cycle. Cycle =28 days
16398800|NCT04774484|Other|High Intensity Interval Training|After the acclimatization session and assessment of eligibility, a graded exercise test (GXT) will be given to the participant. After checking their vitals, the HIIT program will be performed on recumbent cycles. The first two weeks of training will consist of a gradual ramp where subjects will perform a moderate intensity cycling program consisting of a 5-minute warm up followed by progressively longer continuous cycling starting at 15 minutes and progressing up to 30 minutes prior to starting the HIIT training. For the HIIT training subjects will perform 5 minutes of low to moderate steady state cycling to warm up. Following the warm up, the subjects will complete the 4x4 HIIT program. This will consist of 4 minutes of cycling at 85% of the subject's maximum heart rate (HR) followed by 4 minutes of a low intensity cycling period for recovery.
16398801|NCT04767373|Biological|MK-1654|MK-1654 solution
16398802|NCT04767373|Drug|Placebo|Placebo (0.9% sodium chloride [NaCL]) solution
16398803|NCT04764799|Procedure|Rapid sequence induction|Rapid sequence induction starts with the administration of rapid acting intravenous narcotics, opioids and neuromuscular blockage and avoids whenever possible positive-pressure ventilation after induction of anesthesia.
16398806|NCT04762277|Drug|Spesolimab|Spesolimab
16398807|NCT04762277|Drug|Placebo|Placebo
16398820|NCT04754191|Drug|Enfortumab vedotin|Cohort A will be treated with enfortumab vedotin on a 28 day cycle for up to 12 months.
16398821|NCT04751383|Biological|Dinutuximab|Given IV
16398822|NCT04751383|Biological|Magrolimab|Given IV
16398823|NCT04751383|Procedure|Resection|Undergo surgical resection
16398825|NCT04749966|Other|This is an observational study, there are no interventions|This is an observational study, there are no interventions
16398826|NCT04747613|Drug|Iptacopan|Taken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oral
16398827|NCT04745351|Drug|Remdesivir|Administered as Intravenous (IV) infusion once daily
16398828|NCT04745351|Drug|RDV Placebo|Administered as IV saline once daily
16398829|NCT04745351|Drug|Standard of Care|Standard of Care Treatment for COVID-19 Infection
16398836|NCT04739709|Drug|APP13007, 0.05%|APP13007 eye drop, 0.05%
16398837|NCT04739709|Drug|Matching Vehicle Placebo for APP13007, 0.05%|Matching vehicle placebo eye drop
16398838|NCT04739150|Drug|nintedanib|nintedanib
16398839|NCT04736849|Device|Percutaneous epidural and dorsal root stimulation|"Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350)
~Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
~Ripple Neuromed Nomad Neurostimulation System"
16398840|NCT04736628|Drug|BI 685509|BI 685509
16398841|NCT04736628|Drug|Placebo|Placebo
16398842|NCT04736615|Device|SAFEWATER systems for drinking water disinfection|A domestic water purification technology, consisting of a raw water storage tank, a pump, a filtration unit (2 cartridge filters), a UVC disinfection unit (UV lamp), a storage tank for drinking water (treated and safe water), and a distribution network inside the house for drinking water.
16398843|NCT04736615|Behavioral|Behavior change interventions|Targeting behaviors around the use of the technology and water more generally. Behavioral interventions will be data-driven (i.e., dependent on the problems that arise) but are likely to include household and community-level activities.
16398844|NCT04735796|Drug|Drug：LM-102|Traditional '3+3' escalation design will be used. Dose escalation consists of five ascending dose levels of LM-102 (3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg and 40 mg/kg). All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-102 as a 2 h (120±10 min) intravenous (IV) infusion until the disease progression, intolerance, subject discontinuation/informed consent withdrawal, or at the discretion of the investigator in consultation with sponsor, at most till by one year.
16398845|NCT04732871|Biological|RSVPreF3 OA investigational vaccine|RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
16398846|NCT04731077|Device|Avenir Complete Femoral Stem|All enrolled subjects will receive the Avenir Complete Femoral Stem
16398847|NCT04729959|Biological|Atezolizumab|Given IV
16398848|NCT04729959|Procedure|Conventional Surgery|Undergo surgery
16398849|NCT04729959|Radiation|Fractionated Stereotactic Radiation Therapy|Undergo FSRT
16398850|NCT04729959|Biological|Tocilizumab|Given IV
16398851|NCT04729829|Behavioral|Social and behaviour change communication|Each SBC treatment community will receive nutrition content and learning through savings groups. The group members will participate in skill-building activities that promote five key behaviours about fish nutrition and household decision making on fish consumption as part of facilitated discussions, interactive learning sessions, and a video-based facilitated dialogue. Increased fish consumption through SBC mass attendance events through marketing of fish vendors, interactive learning, and edu-tainment competitions promoting fish consumption. SBC will raise awareness of the benefits of eating fish as part of a balanced diet, with a particular focus on pregnant and lactating mothers, and children under 5 years of age.
16398852|NCT04729829|Other|Fish aggregating device|This is a moored line attached to buoys in coastal waters that attracts oceanic fish to it, to make it easier for small-scale fishers to catch them using their existing gear and boats. This FAD will work to increase the catch rate and hence, the availability of fish for sale in upland community markets.
16398853|NCT04729751|Drug|Maralixibat|"Maralixibat chloride provided in the form of an oral solution (i.e., 5, 10, 15, and 20 mg/mL)
~400 μg/kg maralixibat chloride is equivalent to 380 µg/kg maralixibat free base
~600 μg/kg maralixibat chloride is equivalent to 570 µg/kg maralixibat free base"
16398854|NCT04726098|Drug|Dexamethasone high dose|High doses: dexamethasone 20 mg/day 5 days + 10 mg/day 5 days (total 10 days)
16398855|NCT04726098|Drug|Dexamethasone low dose|Low doses: dexamethasone 6 mg/day 10 days.
16398856|NCT04725071|Dietary Supplement|Impact Advanced Recovery|L-arginine and omega-3 rich supplement
16398858|NCT04716166|Other|Volume-oriented incentive spirometry|3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days
16398859|NCT04716166|Other|Flow-oriented incentive spirometry|3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days
16398860|NCT04712838|Drug|SHR0302|Group A subjects were given oral F1 、F2 and F3 version SHR0302
16398861|NCT04712838|Drug|SHR0302|Group B subjects were given oral F1 、F3 and F2 version SHR0302
16398862|NCT04712838|Drug|SHR0302|Group C subjects were given oral F2 、F1 and F3 version SHR0302
16398863|NCT04712838|Drug|SHR0302|Group D subjects were given oral F2 、F3 and F1 version SHR0302
16398864|NCT04712838|Drug|SHR0302|Group E subjects were given oral F3 、F1 and F2 version SHR0302
16398865|NCT04712838|Drug|SHR0302|Group F subjects were given oral F3 、F2 and F1 version SHR0302
16398866|NCT04709484|Drug|USG-guided steroid injection|In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
16398867|NCT04709484|Drug|Palpation-guided steroid injection|In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
16398868|NCT04708704|Dietary Supplement|Erythrosine, prepared in drinking water (0.69 mg/kg bw/day)|Erythrosine will be obtained from Roxy & Rich Inc. (Intense Water-Soluble Food Colorant - Pink), which is certified to be edible and complies with US FDA, Health Canada, and European food safety standards. The erythrosine will be prepared in 500 mL of drinking water and participants will received single daily doses for 14 days. We will use a targeted dose of 0.69 mg/kg bw.
16398869|NCT04708704|Dietary Supplement|SODIS-treated erythrosine, prepared in drinking water (0.69 mg/kg bw/day)|Erythrosine will be SODIS-treated to produce photobleached erythrosine. Transparent 500 mL polyethylene terephthalate (PET) plastic water bottles will be commercially purchased (Kirkland Signature Purified Water). All branding information and labeling will be removed from the bottles. Water bottles will be dosed with ~41 mg erythrosine (0.69 mg/kg bw) using an erythrosine stock solution (8.2 g/L) and will be shaken to mix. The erythrosine-dosed bottles will be placed on a metal shelf and exposed to natural sunlight on the roof of Yale Engineering. Sunlight exposure will be conducted until the absorbance value of erythrosine at the absorption maximum of 526 nm falls below 0.05 above baseline, as measured by ultraviolet-visible spectroscopy. The water bottles containing photobleached erythrosine will be stored under refrigeration in the dark until consumption by participants.
16398870|NCT04708704|Dietary Supplement|Iodine, prepared in drinking water 0.075 mg/kg bw/day)|Iodine used in the study will be in the form of FCC-grade potassium iodide, which will be obtained from VWR. FCC grade potassium iodide meets the requirements set by the Food Chemical Codex and is suitable for all applications in foods and beverages. Iodine (control exposure) will be prepared in 500 mL of drinking water and participants will received single daily doses for 14 days. We will use a targeted dose of 0.75 mg/kg bw.
16398871|NCT04708470|Drug|Bintrafusp Alfa|"Subjects will receive bintrafusp alfa via IV infusion over 1 hour (-10 minutes/+20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. Bintrafusp alfa will be administered as a flat dose of 300 mg independent of body weight. Bintrafusp alfa is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter."
16398872|NCT04708470|Drug|NHS-IL12|NHS-IL12 will be administered at as dose of 7, 6, or 8 microgram/kg by SC injection every 4 weeks. The dose of NHS-IL12 will be calculated based on the weight of the subject determined within 72 hours prior to the day of drug administration. The dose of NHS-IL12 used for the previous administration can be repeated if the change in the subject's weight is 10% or less than the weight used for the last dose calculation.
16398873|NCT04708470|Drug|Entinostat|The entinostat used in this study is a self-administered investigational agent and will be given orally at a designated dose once a week. Number of entinostat tablets will be calculated based on the dose for the participant.
16398874|NCT04708301|Diagnostic Test|T1 mapping|T1 mapping is a specialised heart scan that measures the magnetic properties of heart tissue and displays them as an image or map
16398878|NCT04703192|Drug|Valemetostat Tosylate|Oral administration of valemetostat tosylate at a dose of 200 mg once daily starting at Cycle 1, Day 1 (continuous for 28-day cycles), until disease progression or unacceptable toxicity
16398879|NCT04702425|Drug|VOB560|Powder for concentrate for solution for infusion
16398880|NCT04702425|Drug|MIK665|Concentrate for solution for infusion
16398883|NCT04697472|Device|LIFT System|The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.
16398885|NCT04692493|Drug|tsDMARD class|addition of a targeted synthetic DMARD (choice from 3 targeted synthetic DMARDs) to MTX for in people with active RA despite current MTX treatment
16398886|NCT04692493|Drug|TNFi-biologic class|addition of a TNFi-biologic first to MTX (choice from 5 TNFi-biologics) to MTX for in people with active RA despite current MTX treatment
16398887|NCT04692103|Drug|F-18 16 Alpha-Fluoroestradiol|Undergo F-18 FES PET/CT
16398888|NCT04692103|Procedure|Positron Emission Tomography|Undergo F-18 FES PET/CT
16398889|NCT04692103|Procedure|Computed Tomography|Undergo F-18 FES PET/CT
16398890|NCT04692103|Drug|Fludeoxyglucose F-18|Undergo FDG PET/CT
16398891|NCT04692103|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16398892|NCT04692103|Procedure|Computed Tomography|Undergo FDG PET/CT
16398893|NCT04692103|Other|Laboratory Biomarker Analysis|Correlative studies
16398895|NCT04685668|Behavioral|The PartoMa guidelines and training|"All health care providers (physicians and nurse-midwives) working at the Department of Obstetrics in five study sites during the study period will be invited to participate in knowledge tests of obstetric care and qualitative participant observations as well as in-depth interviews regarding quality of care. This is a part of evaluating the use and effectiveness of the PartoMa intervention.
~The intervention includes the following two components:
~Implementation of a pocket booklet with simple and locally achievable clinical guidance for safe and respectful care at birth developed by the research team and birth attendants at the five hospital study sites;
~Quarterly, the birth attendants will be offered training in the use of the booklet in 3-hour case-based seminars."
16398896|NCT04680390|Behavioral|Standard of care engagement practices|The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
16398897|NCT04680390|Behavioral|Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women|kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
16398898|NCT04677738|Dietary Supplement|B. breve|Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve B-3 in the morning before breakfast for 12 weeks.
16398899|NCT04677738|Dietary Supplement|Placebo|Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks.
16398900|NCT04674124|Behavioral|Brief Online Mindfulness Intervention|A nine-week mindfulness course compromising of 9x weekly 15 minute group sessions which will be on an online platform and daily micro meditations for participants to undertake.
16398901|NCT04673448|Biological|Dostarlimab|Given IV
16398902|NCT04673448|Drug|Niraparib|Given PO
16398903|NCT04672122|Device|Transcranial direct current stimulation|Cathodal tDCS will be applied for 20 mins.
16398904|NCT04670770|Drug|Drug - SHR1459|Oral Tablets taken once daily for 52 weeks
16398905|NCT04658797|Device|somofilcon A Daily Disposable Contact Lens|Daily Disposable Contact Lens
16398906|NCT04658797|Device|Single Vision Spectacle for Vision Correction|Single Vision Spectacle
16398907|NCT04658797|Other|Personal Facemask|Personal Facemask
16398908|NCT04654039|Other|Other: Non intervention|Non intervention
16398909|NCT04653350|Other|High Intensity Exercises|Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.
16398910|NCT04653350|Other|General Exercises|Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training & balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months
16398911|NCT04653285|Behavioral|motor skill practice|Motor learning task on a stability platform (stabilometer). Participants try to keep the tiltable platform in a horizontal position in trials of 30s.
16398912|NCT04653285|Behavioral|aerobic exercise|A bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice.
16398913|NCT04653285|Behavioral|rest|Seated rest following motor skill practice.
16398917|NCT04648189|Drug|Cetuximab|A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
16398921|NCT04643249|Drug|KL1333|Tablet
16398922|NCT04643249|Drug|Flurbiprofen|Tablet
16398923|NCT04643249|Drug|Dextromethorphan|Syrap
16398924|NCT04643249|Drug|Bupropion|Tablet
16398925|NCT04643249|Drug|Midazolam injection|solution for injection
16398926|NCT04643249|Drug|Omeprazole|Capsule
16398927|NCT04643249|Drug|Caffeine|Tablet or capsule
16398928|NCT04643249|Drug|Repaglinide|Tablet
16398929|NCT04642469|Drug|Durvalumab|Intravenous administration of Durvalumab
16398930|NCT04642469|Other|Placebo|Placebo Comparator
16398931|NCT04640272|Drug|RBM-007|Intravitreal injection
16398932|NCT04640194|Drug|Alteplase|Alteplase
16399042|NCT04486677|Behavioral|Caring Cards Group|Group of Veteran card-makers.
16398933|NCT04640194|Procedure|Standard of care|Standard of Care (SOC) includes any supportive measures applied in hospital, specifically on an intensive care unit (ICU), such as for example the use of non-invasive or invasive ventilation, oxygen masks, haemodynamic support, if needed, sedation, as well as medical therapies commonly used in patients suffering from acute respiratory distress syndrome (ARDS) or its complications. SOC should include best possible treatment regimen established locally and should be in line with current guidelines for ARDS treatment.
16398938|NCT04636281|Other|Active and passive static stretching exercises|Different group of muscles will be stretched one by one, tricep brachii, bicep brachii, wrist exentsor etc
16398939|NCT04634045|Behavioral|Web Based Treatment|The literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.
16398942|NCT04631016|Biological|MEDI3506|Dose 1
16398943|NCT04631016|Other|Placebo|Dose 1
16398945|NCT04628767|Drug|Cisplatin|Given IV
16398946|NCT04628767|Drug|Doxorubicin Hydrochloride|Given Iv
16398947|NCT04628767|Biological|Durvalumab|Given IV
16398948|NCT04628767|Drug|Gemcitabine Hydrochloride|Given IV
16398949|NCT04628767|Drug|Methotrexate|Given IV
16398950|NCT04628767|Biological|Pegfilgrastim|Given via injection
16398951|NCT04628767|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16398952|NCT04628767|Drug|Vinblastine Sulfate|Given Iv
16398953|NCT04618705|Behavioral|Smoking Cessation|Participants will start a smoking cessation program.
16398954|NCT04612400|Other|Oral amino acid tracer|Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
16398955|NCT04609943|Drug|BAY1211163 Dose 1|Participants will receive BAY1211163 solution Dose 1 three times per day (TID) by inhalation for seven days.
16398956|NCT04609943|Drug|BAY1211163 Dose 2|Participants will receive BAY1211163 solution Dose 2 three times per day (TID) by inhalation for seven days.
16398957|NCT04609943|Drug|BAY1211163 Dose 3|Participants will receive BAY1211163 solution Dose 3 three times per day (TID) by inhalation for seven days.
16398958|NCT04609943|Drug|BAY1211163 Dose 4|Participants will receive BAY1211163 solution Dose 4 three times per day (TID) by inhalation for seven days.
16398959|NCT04609943|Drug|BAY1211163 Dose 5|Participants will receive BAY1211163 solution Dose 5 three times per day (TID) by inhalation for seven days.
16398960|NCT04608045|Drug|CPX-POM|CPX-POM
16398961|NCT04604197|Other|Angiography and Clinical Follow up|Angiography and Clinical Follow up
16398962|NCT04604197|Other|Clinical Follow up|Clinical Follow up
16398966|NCT04595773|Other|Aerobic Exercise Training|Aerobic exercise training will consist of 10 weeks of aerobic exercise, performed 3 times/week for 30 minutes. Each session will include a warm-up and cool-down period. The intensity will be guided by heart rate and gradually increased from light-moderate to moderate-high intensity as safely tolerated by the subject. All sessions are supervised by credentialed RMD staff members.
16398967|NCT04595773|Other|Education|Education consisting of weekly lectures lasting approximately 1 hour for 10 weeks. Topics related to exercise programming, safety and well-being will be covered. Conducted remotely by credential RMD staff members.
16399043|NCT04486677|Behavioral|Caring Cards Recipients|Group of Veteran card-recipients.
16398969|NCT04589845|Drug|Entrectinib|Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
16398970|NCT04589845|Drug|Entrectinib|Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
16398971|NCT04589845|Drug|Alectinib|Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
16398972|NCT04589845|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged >/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.
16398973|NCT04589845|Drug|Ipatasertib|For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants >/= 35 and < 45 kg, 400 mg for those >/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
16398974|NCT04589845|Drug|Trastuzumab emtansine|Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.
16398975|NCT04589845|Drug|Idasanutlin|"Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart.
~Note: Cohort G has been closed for enrollment."
16398976|NCT04589845|Drug|Inavolisib|GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.
16398977|NCT04589845|Drug|Belvarafenib|Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
16398978|NCT04589845|Drug|Pralsetinib|Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).
16398979|NCT04589195|Behavioral|Mindfulness Training|The intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week.
16398986|NCT04583618|Biological|Pneumococcal Conjugate Vaccine - formulation 1|Pharmaceutical form:Suspension for injection Route of administration: intramuscular
16398987|NCT04583618|Biological|Pneumococcal Conjugate Vaccine - formulation 2|Pharmaceutical form:Suspension for injection Route of administration: intramuscular
16398988|NCT04583618|Biological|Pneumococcal Conjugate Vaccine - formulation 3|Pharmaceutical form:Suspension for injection Route of administration: intramuscular
16398989|NCT04583618|Biological|Pneumococcal 13 - valent conjugate vaccine|Pharmaceutical form:Suspension for injection Route of administration: intramuscular
16398990|NCT04583618|Biological|Pneumococcal Vaccine Polyvalent|Pharmaceutical form:Solution for injection Route of administration: intramuscular
16398991|NCT04581980|Other|Exercise|Participants will exercise on a cycle ergometer
16398992|NCT04581512|Drug|EP0042|EP0042 Oral 20 mg 50 mg capsules
16398998|NCT04567407|Drug|Bilateral erector spinae blocks using ropivacaine|Bilateral chest wall nerve blocks using ropivacaine.
16398999|NCT04566601|Drug|BI 1358894|Film-coated tablet
16399000|NCT04566601|Drug|Placebo|Film-coated tablet
16399003|NCT04551313|Behavioral|social skill group|We plan to address basic interactional and conversational skills first, then focus on teaching perspective-taking and theory of mind skills.
16399004|NCT04551300|Drug|VS-505|4 dosages of experimental drug
16399005|NCT04551300|Drug|Sevelamer Carbonate|Active Comparator
16399006|NCT04551222|Drug|probenecid|1 gr. orally of probenecid twice daily for 180 days
16399007|NCT04551222|Drug|Placebo|identical tablets to probenecid
16399097|NCT04394689|Other|PLA-SC|Placebo saline as subcutaneous injection
16399008|NCT04549246|Radiation|Spatially Fractionated Radiation (GRID) Therapy|Grid therapy allows for high doses of radiation to be delivered over several spatially distinct, small regions. This permits regions of very high dose to a large tumor away from critical structures, which could be beneficial in both palliative and definitive treatments. Additionally, allowing for high doses to be delivered could pose a benefit for radioresistant histologies.
16399009|NCT04546542|Other|Parallel Assignment|We will evaluate 75 patients with pSS (Consenso Americano-europeu de 2002 / EULAR/ACR Classification Criteria, 2016) of both sexes at baseline and 6-months
16399010|NCT04539730|Drug|Liposomal bupivacaine|266 mg or 20 ml Liposomal Bupivacaine injectable solution
16399011|NCT04539730|Procedure|Drug: SoC Ropivacaine|0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
16399012|NCT04537897|Drug|BI 474121|BI474121
16399013|NCT04537897|Drug|Midazolam|Midazolam
16399014|NCT04537897|Drug|Placebo|Placebo
16399017|NCT04530994|Drug|maralixibat|Maralixibat is an Apical Sodium-dependent Bile acid Transporter (ASBT) inhibitor
16399018|NCT04521881|Drug|Tranexamic Acid 500 MG|given once as an intramuscular injection
16399019|NCT04521478|Drug|BI 1358894|BI 1358894
16399020|NCT04521478|Drug|Placebo|Placebo
16399021|NCT04521478|Drug|Quetiapine|quetiapine
16399024|NCT04511130|Drug|MT-401|MT-401 (zelenoleucel) is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells obtained from apheresis.
16399025|NCT04507581|Other|electrical impedance tomography during anaesthesia|Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min). For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm (9). Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated as described previously, using customised software (Matlab R2013a, The MathWorks, Nattick, Massachusetts, USA)(10-12).
16399026|NCT04507308|Behavioral|Single-session sleep intervention drawn from principles of the TranS-C youth protocol|We are providing participants psychoeducation on sleep and will be going over several handouts from the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth) to improve sleep.
16399027|NCT04507269|Drug|VIR-2218|VIR-2218 given by subcutaneous injection
16399028|NCT04507269|Drug|Placebo|Saline given by subcutaneous injection
16399029|NCT04502693|Combination Product|rMenB+OMV NZ vaccine|rMenB+OMV NZ vaccine is administered intramuscularly to the non-dominant arm as 3 doses in a 0,2,6-M schedule or as 2 doses in a 0,6-M schedule to participants in the MenB_0_2_6 Group, as 2 doses in a 0,6-M schedule to participants in the MenB_0_6 Group and as 2 doses at Day 181 and Day 211 to participants in the ACWY Group.
16399030|NCT04502693|Biological|Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)|MenACWY vaccine is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_2_6 Group, as 1 dose at Day 61 to participants in the MenB_0_6 Group and as 1 dose at Day 1 to participants in the ACWY Group.
16399031|NCT04502693|Combination Product|Placebo|Placebo is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_6 Group, 2 doses at Day 61 and Day 211 to participants in the ABCWY groups and as 1 dose at Day 61 to participants in the ACWY Group.
16399032|NCT04502693|Combination Product|MenABCWY-1|Lot 1 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-1 Group.
16399033|NCT04502693|Combination Product|MenABCWY-2|Lot 2 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-2 Group.
16399034|NCT04502693|Combination Product|MenABCWY-3|Lot 3 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-3 Group.
16399035|NCT04496349|Drug|APG-115|APG-115 given orally for first 5 consecutive days each cycle
16399036|NCT04496349|Drug|APG-2575|APG-2575 given orally each day in cycle
16399037|NCT04495153|Biological|Aglatimagene besadenovec|Two courses of GMCI each involving aglatimagene besadenovec injection into an accessible involved tumor site followed by 14 days of oral valacyclovir. Patients will continue standard of care immune checkpoint inhibitor with or without chemotherapy.
16399038|NCT04491955|Biological|CV301|CV301 vaccine consists of MVA-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10^8 infectious units/0.5 mL each) will be administered as four subcutaneous injections on D1 and D15. Starting on D29, FPV-CV301 (1 x 10^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.
16399039|NCT04491955|Drug|MSB0011359C|"Subjects will receive M7824 via IV infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter."
16399040|NCT04491955|Drug|N-803|N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 8, 10 or 15 mcg/kg by SC injection every 4 weeks on Arm 2A and Arm 2B according to the dose escalation schema, and the MTD or highest dose identified.
16399041|NCT04491955|Drug|NHS-IL12|NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks on Arms 2A and 2B.
16399045|NCT04479176|Procedure|Transnasal Sphenopalatine Ganglion Block|In transnasal approach, several authors described the traditional technique using sterile 10cm cotton tipped applicators that are dipped in the chosen anesthetic and then advanced along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx. Some other techniques had described dripping one or two ml of the anesthetics into the nostril.
16399046|NCT04474886|Dietary Supplement|Fresubin® powder fibre|2 servings per day
16399047|NCT04470622|Drug|Aprepitant injectable emulsion|Aprepitant injectable emulsion, once daily (QD) for 14 days.
16399048|NCT04470622|Drug|Saline Placebo|Saline Placebo, once daily (QD) for 14 days.
16399049|NCT04439253|Drug|Crizotinib|Given PO
16399050|NCT04435249|Other|BPF-001|Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold
16399051|NCT04429464|Device|AcQBlate Force Sensing Ablation Catheter|Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias
16399052|NCT04425720|Device|LifeSignals Biosensor 1AX*|Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX* and a pulse oximeter.
16399053|NCT04425720|Other|Standard of Care|This group will be treated based on standard of care at our institution.
16399057|NCT04409236|Behavioral|Quit2Heal|Use Quit2Heal app
16399058|NCT04409236|Behavioral|QuitGuide|Use QuitGuide app
16399059|NCT04409236|Other|Survey Administration|Ancillary studies
16399061|NCT04406792|Behavioral|Alternative Lifestyle Interventions in Vulnerable Ethnic groups|Participation in the ALIVE intervention
16399062|NCT04406792|Behavioral|Diabetes Prevention Program (DPP) online|Participation in the DPP online intervention
16399063|NCT04406792|Behavioral|Standard of Care|Standard of care
16399064|NCT04405297|Device|Adipose-derived regenerative cells|Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint.
16399065|NCT04404192|Drug|PH94B|Intranasal administration of 100 microliters to each nostril 4 times a day
16399066|NCT04404192|Drug|Placebo|Intranasal administration of 100 microliters to each nostril 4 times a day.
16399069|NCT04400838|Biological|ChAdOx1 nCoV-19 (Abs 260)|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
16399070|NCT04400838|Biological|MenACWY vaccine|Standard single dose of MenACWY vaccine
16399071|NCT04400838|Biological|ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later
16399072|NCT04400838|Biological|Two dose MenACWY vaccine|Two standard doses of MenACWY vaccine 4-6 weeks apart
16399073|NCT04400838|Biological|ChAdOx1 nCoV-19 (qPCR)|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
16399074|NCT04400838|Biological|ChAdOx1 nCoV-19 0.5mL prime plus boost|Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
16399075|NCT04400838|Biological|Two dose MenACWY vaccine min. 4 weeks apart|Two standard doses of MenACWY vaccine minimum 4 weeks apart
16399076|NCT04400838|Biological|Two dose ChAdOx1 nCoV-19/Covishield 0.5mL|Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
16399077|NCT04400838|Biological|Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL|Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
16399078|NCT04399837|Drug|Spesolimab|Solution for injection
16399079|NCT04399837|Drug|Placebo|Solution for injection
16399080|NCT04398407|Behavioral|Coaching and Advancement for Peer Providers (CAPP)|The CAPP intervention will combine executive coaching approaches and techniques with the specific needs and environmental demands of individuals working as PSS. A person who has been a PSS and trainer of PSS nationally has developed the CAPP intervention using the expertise of Center staff, the Harvard Institute of Coaching (IOC) and our Peer Advisory Group. Individuals randomized to the experimental condition will receive 16 individual coaching sessions tailored to the specific job stressors they are experiencing. CAPP is designed to address the following issues: role confusion, lack of clarity about job tasks, conflict with other providers, burnout, lack of organizational commitment and job satisfaction.
16399081|NCT04396873|Drug|11C-MC1|Injected IV followed by PET scanning
16399082|NCT04396873|Drug|11C-PS13|Injected IV followed by PET scanning
16399083|NCT04396873|Drug|18f-florbetaben|Injected IV followed by PET scanning
16399094|NCT04394689|Biological|Measles Rubella Vaccine (MRV-SC)|One dose as subcutaneous injection of a WHO prequalified MR vaccine
16399095|NCT04394689|Biological|MRV-MNP|One standard dose of Measles and Rubella vaccine delivered intradermally as a dissolving microneedle patch
16399096|NCT04394689|Other|PLA-MNP|One placebo dose of a dissolving microneedle patch
16399098|NCT04393753|Drug|domatinostat in combination with avelumab|domatinostat tablets and avelumab infusion
16399099|NCT04393701|Procedure|Additional blood sampling|Additional blood sampling on blotting paper will be done in neonates in Normandy, France, compared to National neonatal screening program
16399100|NCT04390308|Procedure|Ovarian puncture|Egg collection
16399101|NCT04390308|Other|Hormonal blood Test|AMH (ng/ml), FSH (IU/mL), E2(pg/mL), P4(ng/mL), LH (IU/mL)
16399102|NCT04390308|Diagnostic Test|Transvaginal ultrasound|Doppler of arteria ovarica. Resistance index
16399107|NCT04385368|Drug|Durvalumab + SoC chemotherapy|Experimental Treatment
16399108|NCT04385368|Other|Placebo + SoC chemotherapy|Placebo Comparator
16399109|NCT04384484|Drug|Loncastuximab Tesirine|Intravenous Infusion
16399110|NCT04384484|Drug|Rituximab|Intravenous Infusion
16399111|NCT04384484|Drug|Gemcitabine|Intravenous Infusion
16399112|NCT04384484|Drug|Oxaliplatin|Intravenous Infusion
16399113|NCT04381936|Drug|Lopinavir-Ritonavir|Lopinavir 400mg-Ritonavir 100mg by mouth (or nasogastric tube) every 12 hours for 10 days.
16399114|NCT04381936|Drug|Corticosteroid|Corticosteroid in the form of dexamethasone administered as an oral (liquid or tablets) or intravenous preparation 6 mg once daily for 10 days. In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or intravenous hydrocortisone 80 mg twice daily) should be used instead of dexamethasone. Corticosteroid (in children ≤44 weeks gestational age, or >44 weeks gestational age with PIMS-TS only) in the form of Hydrocortisone or Methylprednisolone sodium succinate (see Protocol for timing and dosage)
16399115|NCT04381936|Drug|Hydroxychloroquine|Hydroxychloroquine by mouth for a total of 10 days (see Protocol for timing and dosage).
16399116|NCT04381936|Drug|Azithromycin|Azithromycin 500mg by mouth (or nasogastric tube) or intravenously once daily for 10 days.
16399117|NCT04381936|Biological|Convalescent plasma|Single unit of ABO compatible convalescent plasma (275mls +/- 75 mls) intravenous per day on study days 1 (as soon as possible after randomisation) and 2 (with a minimum of 12 hour interval between 1st and 2nd units).
16399118|NCT04381936|Drug|Tocilizumab|Tocilizumab by intravenous infusion with the dose determined by body weight (see Protocol for dosage)
16399119|NCT04381936|Biological|Immunoglobulin|Intravenous immunoglobulin (IVIg) for children >44 weeks gestational age and <18 years with PIMS-TS only (see Protocol for dosage)
16399120|NCT04381936|Drug|Synthetic neutralising antibodies|For participants ≥12 years only with COVID-19 pneumonia: A single dose of REGN10933 + REGN10987 8 g (4 g of each monoclonal antibody) in 250ml 0.9% saline infused intravenously over 60 minutes +/- 15 minutes as soon as possible after randomisation
16399121|NCT04381936|Drug|Aspirin|150 mg by mouth (or nasogastric tube) or per rectum once daily until discharge, for adults ≥18 years old.
16399122|NCT04381936|Drug|Colchicine|1 mg after randomisation followed by 500mcg 12 hours later and then 500 mcg twice daily by mouth or nasogastric tube for 10 days in total, for men ≥18 years old and women ≥55 years old only
16399123|NCT04381936|Drug|Baricitinib|UK [age ≥2 years with COVID pneumonia] and India [age ≥18 years with COVID-19 pneumonia]: 4 mg once daily by mouth or nasogastric tube for 10 days in total.
16399124|NCT04381936|Drug|Anakinra|For children ≥1 <18 years old only: subcutaneously or intravenously once daily for 7 days or discharge (if sooner). NB Anakinra will be excluded from the randomisation of children <10 kg in weight.
16399125|NCT04381936|Drug|Dimethyl fumarate|Early phase assessment. UK adults ≥18 years old only (excluding those on ECMO). 120 mg every 12 hours for 4 doses followed by 240 mg every 12 hours by mouth for 8 days (10 days in total).
16399126|NCT04381936|Drug|High Dose Corticosteroid|Ex-UK, adults ≥18 years old with hypoxia only. Dexamethasone 20 mg (base) once daily by mouth, nasogastric tube or intravenous infusion for 5 days follow by dexamethasone 10 mg (base) once daily by mouth, nasogastric tube or intravenous infusion for 5 days.
16399127|NCT04381936|Drug|Empagliflozin|Adults ≥18 years old only. 10 mg once daily by mouth for 28 days (or until discharge, if earlier).
16399128|NCT04381299|Other|autologous platelet rich plasma|The cortex of selected ovary will be injected with 1 mL of autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.
16399129|NCT04381299|Other|saline solution|The cortex of contralateral ovary will be injected with 1 mL of saline solution (SS). Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.
16399130|NCT04381039|Device|Insole|3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only
16399131|NCT04379986|Device|Senbiosys|The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
16399133|NCT04373317|Drug|Pimavanserin|Pimavanserin is a new antipsychotic agent, and pure 5HT-2A inverse agonist, that was approved by the FDA recently (2016) for the treatment of PDP.
16399134|NCT04373317|Drug|Quetiapine|Quetiapine, which is a mixed serotonin and dopamine receptor antagonist but also binds to many other brain receptors (e.g., adrenergic, cholinergic, histaminergic receptors), is by far the most commonly used AP for PDP (at least 70% of prescriptions) and does not require special monitoring.
16399135|NCT04372927|Drug|Cisplatin|Given IV
16399136|NCT04372927|Biological|Durvalumab|Given IV
16399137|NCT04372927|Drug|Etoposide|Given IV
16399138|NCT04372927|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
16399139|NCT04372927|Drug|Pemetrexed|Given IV
16399145|NCT04370574|Diagnostic Test|Soluble Biomarkers dosage|"CytoLyt® fluid will be first processed for routine PDAC diagnosis. In essence, the samples are filtered, tissue fragments and cells are kept for analysis while flow-through is kept until the diagnosis is confirmed. Once this is completed, the samples will be transferred to the lab where the proteins found in the CytoLytR fluid will be precipitated and then solubilized. The protein extracts are stored at -80°C pending proteomic analysis. The remaining CytoLytR fluid supernatant is also stored at - 80°C to be used for metabolomics.
~Blood sample will be collected from each patient that underwent diagnostic biopsy. Dry tube for serum analysis will be collected at the time of inclusion during the routine blood test. The serum samples are intended for the validation phase (WP4) and will be exclusively dedicated to this study."
16399146|NCT04366713|Drug|Neratinib|Administered orally once daily as a single daily dose of 240 mg
16399147|NCT04366713|Drug|Capecitabine|Administered orally twice daily at 750 mg/m^2 for 14 days of each 21 day treatment cycle
16399148|NCT04366713|Drug|Loperamide|Administered orally for prophylaxis for 28 days and then as needed
16399149|NCT04362254|Drug|Spesolimab|Spesolimab
16399150|NCT04362046|Procedure|Hysteroscopic uterine resection|"Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy.
~HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications."
16399151|NCT04358393|Drug|APG-115|APG-115 given once daily on day 1-5 of every 28 day cycle
16399152|NCT04358393|Drug|5-azacitidine|5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days
16399153|NCT04353973|Other|Pre-Test Intervention|Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
16399154|NCT04353973|Other|Standard of Care|Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
16399155|NCT04353973|Other|Post-Test Intervention|Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
16399157|NCT04338399|Drug|Buparlisib & Paclitaxel|Investigation drug plus paclitaxel
16399158|NCT04337931|Drug|APX005M|2 different administration schedules per treatment cycle
16399159|NCT04327284|Device|Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm)|"At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow.
~The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months."
16399160|NCT04327284|Device|Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)|"At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow.
~The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months."
16399161|NCT04319198|Drug|Sacituzumab Govitecan-hiy|Administered intravenously
16399162|NCT04318704|Drug|Ifenprodil|Ifenprodil 20 mg TID
16399163|NCT04317937|Other|Jaw opening-closing movements|"Jaw opening-closing movements Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.
~Active jaw movements The patient will then perform maximal Jaw opening-closing movements at a pace convenient for his/her for one minute. Three sets with two minutes rest in between will be ensured.
~Active neck exercises While performing the above movements of jaws, the patient will actively perform active neck exercise (head-neck movements in sagittal plane- Extension- Flexion).
~Head-Neck extension on jaw opening (Mandible moves vertically downward); and then from Head-Neck extension to natural flexion movement on jaw closing (Mandible moves vertically upward)."
16399164|NCT04317937|Other|Specific Active exercises|"Active neck exercises:
~Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.
~Note: For Active neck exercise (flexion and extension movements of neck), firstly the patient will perform maximal Jaw opening-closing movements at a pace convenient for his/her for 5 times in order to observe (eyeball observation) the neck extension and flexion as reference point for each individual.
~Using this reference points, the patient will ask perform below mentioned active neck exercise.
~Active neck exercises: The patient will then perform active neck exercise (flexion and extension of neck) at a pace convenient for his/her for one minute. Three sets with two minutes rest in between will be ensured.
~Active jaw movement: While performing the above movements of neck, the patient will not perform any jaws movements."
16399211|NCT04250337|Biological|Lebrikizumab|Subcutaneous injection
16399212|NCT04250337|Other|Placebo|Subcutaneous injection
16399165|NCT04317937|Other|Exercise Therapy|"Isometric strengthening exercises For flexion the starting position will be upright head and neck. The patient will be asked to hold this position.
~For extension the starting position will be upright head and neck. The patient will be asked to hold this position.
~For rotation the starting position will be upright head and neck. The patient will be asked to hold this position.
~• In all above movements ( flexion, extension & rotation) following method will be followed: Manual resistance will then be applied by the investigator by placing the hand on the patient's forehead, posterior part of the head and lateral part of the head with 6 second hold. 15 repetitions of this exercise will be performed. Three sets with one minute rest in between will be ensured."
16399166|NCT04317937|Other|Supportive Treatment|"Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program. Postural Advise Maintain upright posture while sitting.
~Avoid prolonged neck bending.
~Avoid twisting movement of the neck.
~Use a suitable pillow to maintain cervical spine.
~Adjust computer screen at eye level.
~Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
~Carry light and even weight in both hands while shopping and other chores.•Stay hydrated.
~Home Exercise Program (unsupervised) (3 times a day)
~Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
~Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
~Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
~Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15
~Home Dairy A home dairy will be provided to maintain home exercise program record."
16399173|NCT04307186|Drug|BAY1747846|Solution for IV injection, single dose
16399174|NCT04307186|Drug|Gadobutrol (Gadovist/Gadavist)|Solution for IV injection, single dose
16399175|NCT04301687|Procedure|Femoral Articular Branch Block|Slow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance.
16399176|NCT04301687|Procedure|Placebo Block|Subcutaneous injection of 1ml normal sterile saline
16399181|NCT04295902|Device|C-MAC indirect videolaryngoscope with blades Miller nr 0 and Miller nr 1.|Tracheal intubation performed with the C-MAC indirect videolaryngoscope (Karl Storz, Tuttlingen, Germany) with blades Miller nr 0 and Miller nr 1.
16399182|NCT04295902|Device|Direct laryngoscope with blades Miller nr 0 and Miller nr 1.|Tracheal intubation performed with a standard direct laryngoscope, with standard blades Miller nr 0 and Miller nr 1
16399183|NCT04295538|Drug|Elezanumab|Solution for infusion; Intravenous (IV)
16399184|NCT04295538|Drug|Placebo|Solution for infusion; Intravenous (IV)
16399185|NCT04287868|Biological|PDS0101|PDS0101 will be administered on D1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP) injection.
16399186|NCT04287868|Biological|M7824|M7824 will be administered at a flat dose of 1,200 mg IV (over 1 hour) once every 2 weeks.
16399187|NCT04287868|Biological|NHS-IL12|NHS-IL12 will be administered at as dose of potentially de-escalating doses by SC injection every 4 weeks.
16399188|NCT04285983|Drug|Trelagliptin|Trelagliptin tablets
16399189|NCT04280692|Biological|PfSPZ Challenge|Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites
16399190|NCT04280692|Drug|Sulfadoxine-Pyrimethamine|Sub-curative 500mg/25mg single dose regimen
16399191|NCT04280692|Drug|Piperaquine|Sub-curative 480mg single dose regimen
16399192|NCT04280692|Drug|Artemether lumefantrine|Three day curative regimen 20mg/120mg
16399193|NCT04280692|Drug|Primaquine|Single low dose regimen 0.25 mg base/kg
16399194|NCT04270422|Other|Multidimensional physiotherapy|Multidimensional physiotherapy based on biopsychosocial approach
16399195|NCT04270422|Other|Usual physiotherapy|Usual evidence based physiotherapy
16399196|NCT04268693|Other|urine collection|Collect three urine samples either in the clinic or at home. This will occur prior to starting neoadjuvant chemotherapy, and again at the end of the scheduled course of neoadjuvant chemotherapy.
16399206|NCT04263584|Drug|Copanlisib|Copanlisib vials 60 mg
16399207|NCT04263584|Drug|R-CHOP Chemotherapy|Immunochemotherapy
16399208|NCT04260022|Drug|Ascentage Pharma HQP1351 bioavailable inhibitor|HQP1351 taken by mouth every other day
16399213|NCT04250337|Other|Topical Corticosteroid|Topical Corticosteroid
16399214|NCT04245345|Device|Accelerometer Sensing for Micra AV Study|Characterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System.
16399215|NCT04238494|Diagnostic Test|Nuclear magnetic resonance (NMR)|Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)
16399216|NCT04234854|Diagnostic Test|Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent|IVUS will be performed after stent postdilatation to determine the incidence of plaque prolapse. Additionally optimizing stent expansion with IVUS is left at operator discretion.
16399217|NCT04233268|Diagnostic Test|Rapid Pathogen Detection|Rapid assays for pathogen detection on bronchoalveolar lavage fluid
16399218|NCT04232553|Drug|Mirikizumab|Administered IV
16399219|NCT04232553|Drug|Mirikizumab|Administered SC
16399220|NCT04231032|Other|Asynchronous dual chamber pacing (DOO) with paced ventricular activation|Alteration of the participant's existing pacemaker mode to either paced or intrinsic ventricular activation (in an order based upon randomisation).
16399221|NCT04231032|Other|Asynchronous atrial pacing (AOO) with intrinsic ventricular activation|Alteration of the participant's existing pacemaker mode to either paced or intrinsic ventricular activation (in an order based upon randomisation).
16399222|NCT04223557|Device|High-intensity focused ultrasound|"High-intensity focused ultrasound(HIFU) is an externally delivered, completely noninvasive focused therapeutic ultrasound device.It is capable of focusing the resulting ultrasound beam to a small cigar-shaped volume,which leads to the rapid elevation of the peri-renal adipose tissue temperature and the modification of target tissue eventually."
16399223|NCT04223557|Device|Sham treatment|Participants will receive the same procedure as those in the HIFU treatment including peri-renal fat ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the peri-renal fat.
16399224|NCT04222504|Behavioral|Provision of sexual health preventative services in the salon setting|"Participants at intervention salons will be offered a choice of receiving daily PrEP and/or contraceptives (oral and injectables). Participants that elect to receive at least PrEP or contraceptives will also be offered STI testing.
~Follow-up visits will be planned for 3, 6, 9, and 12-months. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services."
16399234|NCT04208256|Dietary Supplement|Energy Stimulus|Energy stimulus (energy surplus v. energy neutral) will be randomly assigned at the first brain imaging visit. At the second brain imaging visit, the participant will receive the alternate stimulus from what they received at the first brain imaging visit.
16399235|NCT04206553|Drug|dupilumab|Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.
16399236|NCT04206553|Drug|Matching Placebo|Matching dupilumab without active substance
16399237|NCT04206553|Drug|Oral corticosteroids (OCS)|Prednisone or prednisolone per standard of care to obtain control of disease activity.
16399238|NCT04203823|Device|Cloud-based Digital Twin and Meal Prediction algorithms|Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms
16399239|NCT04199052|Behavioral|LinkPositively|LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system.
16399240|NCT04192929|Device|Narrow band imaging|Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes
16399241|NCT04192929|Other|Chromoendoscopy|Indigo carmine will be sprayed during withdrawal phase of colonoscopy
16399242|NCT04192929|Other|High definition white light endoscopy|High definition equipment will be used to perform colonoscopy
16399243|NCT04192045|Other|Survey|A survey will be used at 24 hours and 30 days to assess the quality of recovery
16399244|NCT04190524|Other|Application of cricoid pressure|The study first involves recording a baseline image of the neck anatomy using ultrasound, which is a non-invasive, non-irradiating, non-painful imaging modality. Once the baseline anatomy has been imaged, conventional cricoid pressure will be applied with fingers and/or with the ultrasound probe itself and an image will be recorded. The force applied to the cricoid cartilage will be 30 newtons, as determined by a thin force measurement sensor (Tekscan flexiforce sensor) placed in between the patient's skin and the finger (or ultrasound probe).
16399245|NCT04190524|Other|Application of Left lateral paratracheal pressure|Next, left lateral paralaryngeal pressure will be applied at the level of the cricoid cartilage with fingers and/or the ultrasound probe itself, and the image will again be recorded. Left lateral paralaryngeal pressure will be 30 newtons, as determined by a thin force measurement sensor placed in between the patient's skin and the finger (or ultrasound probe).
16399249|NCT04167540|Biological|AAV2-GDNF|Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
16399250|NCT04166552|Drug|Patients will be randomized to receive EHP-101 or Placebo|EHP-101 or placebo will be taken once a day
16399251|NCT04166552|Drug|Patients will be randomized to receive EHP-101 or Placebo|EHP-101 or placebo will be taken twice a day
16399252|NCT04159103|Biological|mRNA-3927|mRNA-3927 dispersion for IV infusion
16399253|NCT04158635|Drug|Bosentan|Given PO
16399254|NCT04158635|Drug|Gemcitabine|Given IV
16399255|NCT04158635|Drug|Nab-paclitaxel|Given IV
16399256|NCT04158635|Other|Quality-of-Life Assessment|Ancillary studies
16399257|NCT04158635|Other|Questionnaire Administration|Ancillary studies
16399258|NCT04150068|Drug|Oral Lenacapavir|Tablets administered without regard to food
16399259|NCT04150068|Drug|Oral Lenacapavir Placebo|Tablets administered without regard to food
16399260|NCT04150068|Drug|Subcutaneous Lenacapavir|Administered in the abdomen via subcutaneous injections
16399261|NCT04150068|Drug|Failing ARV Regimen|Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
16399262|NCT04150068|Drug|Optimized Background Regimen (OBR)|Optimized background regimen as prescribed by the Investigator
16399263|NCT04147715|Drug|S-648414|Tablet for oral administration
16399264|NCT04147715|Drug|Placebo|Tablet for oral administration
16399265|NCT04147715|Drug|Midazolam|Solution for oral administration
16399266|NCT04147715|Drug|Dolutegravir|Tablet for oral administration
16399267|NCT04145388|Other|online cancer risk assessment|Electronic surveys to collect family cancer history information.
16399268|NCT04145388|Other|Usual care|Family cancer history captured by provider during a clinical encounter
16399271|NCT04139200|Behavioral|Type 1 physical activity tele coaching intervention|A) Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed. B) Step counter providing direct feedback. C) A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards. D) Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data, failure to progress or change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.
16399272|NCT04139200|Behavioral|Type 2 physical activity tele coaching intervention|A) Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity. B) A step counter providing direct feedback. C) A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period). D) Telephone contacts triggered in the case of change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.
16399273|NCT04137224|Biological|IgPro20|Human normal immunoglobulin for subcutaneous administration
16399274|NCT04137224|Biological|IgPro10|Human normal immunoglobulin for intravenous administration
16399275|NCT04129775|Drug|OTO-413|Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
16399276|NCT04129775|Drug|Placebo|Single intratympanic injection of placebo
16399277|NCT04126317|Drug|aflibercept|Intravitreally (IVT) administered as a liquid formulation in a vial
16399278|NCT04126317|Drug|High-dose aflibercept|Intravitreally (IVT) administered as a liquid formulation in a vial
16399279|NCT04126083|Drug|Lofexidine Oral Tablet|Open label trial of lofexidine to facilitate opioid tapering prior to elective lumbar spine surgery.
16399280|NCT04120116|Drug|FX-322 (One Dose)|Patients will receive one dose of FX-322.
16399281|NCT04120116|Drug|FX-322 (Two Doses)|Patients will receive two doses of FX-322.
16399282|NCT04120116|Drug|FX-322 (Four Doses)|Patients will receive four doses of FX-322.
16399283|NCT04120116|Drug|Placebo|Patients will receive Placebo.
16399285|NCT04112797|Biological|Allergovac himenoptera|Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula
16399288|NCT04102436|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
16399289|NCT04102436|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
16399290|NCT04102436|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg (based on total body weight) IV over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses). Patients in Cohort 3 may be eligible to receive 72,000 IU/kg IV.
16399291|NCT04102436|Biological|Sleeping Beauty Transposed PBL|Day 0: Cells are to be infused at a dose not to exceed 1.5e11 in 400 mL intravenously on the Patient Care Unit over 20-30 minutes or as clinically determined by an investigator for patient safety (between 2-4 days after the last dose of fludarabine).
16399292|NCT04094012|Drug|isoniazid and rifapentine|This prospective multicenter randomized control trial (RCT) will be conducted on LTBI cases (see 2. Study population) to compare the risk of SDRs under conventional 3HP regimen (Arm 1: 3HP) and a new regimen consisting of daily RPT (10 mg/kg) plus INH (5 mg/kg) for 1 month (Arm 2: 1HP)
16399293|NCT04091386|Drug|Damoctocog alfa pegol (Jivi, BAY94-9027)|Intervention is given as part of routine medical practice
16399294|NCT04091048|Device|Evolut™ PRO and Evolut™ PRO+ System|Aortic valve replacement
16399295|NCT04088552|Other|"Go4Life-Physical Activity/Exercise Program Workout to Go 5"|"The Go4Life-Physical Activity/Exercise Program Workout to Go 5 Program is an exercise regimen provided to participants. Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session. Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen."
16399296|NCT04088552|Behavioral|ActuaYa Educational Sessions|The ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration. Each session will be conducted in separate groups of 6-10 participants. Session 1 will discuss the impact of chronic disease in the older Hispanic community. Session 2 will discuss the communication and negotiation with the family and partner. Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle.
16399301|NCT04083170|Drug|Fludarabine|Given IV
16399302|NCT04083170|Drug|Cyclophosphamide|Given IV
16399303|NCT04083170|Drug|Thiotepa|Given IV
16399304|NCT04083170|Radiation|Total-Body Irradiation|Undergo TBI
16399305|NCT04083170|Procedure|Umbilical Cord Blood Transplantation|Undergo UCBT
16399306|NCT04083170|Other|Cellular Therapy|Given OTS IV
16399307|NCT04082364|Combination Product|margetuximab plus INCMGA00012|"margetuximab: Fc-modified anti-HER2 monoclonal antibody:
~• 15 mg/kg IV Day1 of each 3 week cycle
~INCMGA00012: anti-PD-1 checkpoint inhibitor:
~• 375 mg IV Day 1 of each 3 week cycle"
16399308|NCT04082364|Combination Product|Margetuximab plus INCMGA00012 plus chemo|"margetuximab: Fc-modified anti-HER2 monoclonal antibody
~• 15 mg/kg IV Day1 of each 3 week cycle
~INCMGA00012: anti-PD-1 checkpoint inhibitor
~• 375 mg IV Day 1 of each 3 week cycle
~Chemotherapy
~Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy
~Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy
~Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6
~Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy"
16399309|NCT04082364|Combination Product|Margetuximab plus MGD013 plus chemo|"margetuximab: Fc-modified anti-HER2 monoclonal antibody
~• 15 mg/kg IV Day1 of each 3 week cycle
~MGD013: Anti-PD-1, anti-LAG-3 dual checkpoint inhibitor DART molecule
~• Dosing regimen located in the protocol
~Chemotherapy
~Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy
~Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy
~Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6
~Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy"
16399310|NCT04082364|Combination Product|Margetuximab plus chemo|"margetuximab: Fc-modified anti-HER2 monoclonal antibody
~• 15 mg/kg IV Day1 of each 3 week cycle
~Chemotherapy
~Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy
~Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy
~Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6
~Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy"
16399311|NCT04082364|Combination Product|Trastuzumab plus chemo|"Anti-HER2 monoclonal antibody
~• 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3 week cycle
~Chemotherapy
~Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy
~Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy
~Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
~Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6
~Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy"
16399312|NCT04074616|Device|High Dose|Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
16399313|NCT04074616|Device|Low dose|Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
16399314|NCT04074083|Behavioral|electronic IMCI|Participants will be trained to use an electronic version of the Integrated Management of Childhood Illness (IMCI) guidelines
16399315|NCT04074083|Behavioral|paper IMCI|Participants will be trained to use routine paper version of Integrated Management of Childhood Illness (IMCI) guidelines
16399316|NCT04062266|Drug|Azacitidine|Given SC or IV
16399317|NCT04062266|Drug|Venetoclax|Given PO
16399318|NCT04061226|Device|Overnight polysomnography|Overnight polysomnography will be performed in a sleep laboratory (EEG, EOG, EMG, ECG, respiratory movements of the chest and abdomen, oro-nasal airflow, and O2 saturation will be examined
16399319|NCT04056273|Other|Guide sheath group|After the lesion was found by rEBUS, insert the rEBUS into a guide sheath and re-locate the lesion. Fix the guide sheath at that position and perform transbronchial biopsy and brushing through the guide sheath.
16399320|NCT04056273|Other|Conventional group|After the lesion was found by rEBUS, mark the location and depth. Insert the biopsy forceps and cytology brush to the marked depth of that bronchiole to perform biopsy and brushing.
16399324|NCT04044001|Drug|BTZ-043|BTZ-043 (250mg per tablet)
16399325|NCT04044001|Drug|Rifafour e-275®|Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
16399326|NCT04044001|Drug|Probe Drug Cocktail|"A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
~Caffeine: 1 tablet à 150mg
~Tolbutamide: 1/4 tablet à 500mg
~Dextromethorphan: 10 ml syrup à 15mg/5ml
~Midazolam:2 ml solution à 5mg/5ml
~Digoxin: 2 tablets à 0.25mg"
16399327|NCT04044001|Drug|Dolutegravir 50mg Tab|1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
16399328|NCT04043377|Drug|injection of 68Ga-DOTATATE|PET after injection of 68Ga-DOTATATE 2 MBq/kg (Max. 200 MBq); intra-venous; single injection, at M0 followed by a coronary CTA to localize the signal in coronary arteries Consultation and low-dose cardiac CT for coronary calcium scoring performed at M12 and M24 after inclusion.
16399329|NCT04039022|Drug|AXS-05|Oral tablets, taken twice daily for up to 12 months.
16399332|NCT04021381|Dietary Supplement|Potassium and magnesium citrate|Patients are treated with potassium and magnesium citrate 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
16399333|NCT04021381|Dietary Supplement|Placebo|Patient are treated with placebo 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
16399334|NCT04020523|Other|MRI sequence|The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.
16399335|NCT04017962|Drug|Letermovir Pill|Patients enrolled on the study will receive oral LTV 480 mg daily (240 mg daily for patients receiving cyclosporine A). The maximum duration of LTV administration will be 14 weeks. Patients receiving oral medication will be administered a pill diary for drug compliance purposes. This will be administered and reconciled in clinic.
16399336|NCT04017962|Other|blood draw|Collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
16399337|NCT04012996|Device|prodisc C SK and/or Vivo|Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
16399338|NCT04012996|Device|Mobi-C Cervical Disc|Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
16399339|NCT04010721|Device|Experiment 1|Stimulation of one electrode at a time
16399340|NCT04010721|Device|Experiment 2:|Stimulation in groups of 4, 8 and 12 electrodes
16399341|NCT04010721|Device|Experiment 3|Stimulation total duration from 10 to 600 ms
16399342|NCT04008576|Behavioral|Group Blended Transdiagnostic treatment|The treatment combines group face-to-face and Internet-delivered psychotherapy: 7 group sessions delivered every 3 weeks plus the use of an online treatment platform between sessions. Its goal is to learn and practice adaptive regulation strategies from a mechanistically transdiagnostic approach, with a focus on both negative and positive affectivity. Each group session will focus on one of the following core components: the first group session will focus on CBT traditional strategies such as motivation for change and psychoeducation about emotions; sessions 2 to 5 will focus on strategies to down-regulate negative affect: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, and interoceptive and situation-based emotion exposure; session 6 will focus on strategies to regulate positive affect; the final session will teach relapse prevention techniques. All the treatment components are delivered in 16 online treatment modules.
16399343|NCT04007367|Drug|SAGE-217|SAGE-217
16399344|NCT04007367|Drug|Placebo|Placebo
16399345|NCT04005495|Behavioral|Teaching kitchen program|The teaching kitchen program will include five 4-hour Saturday classes every other weekend over the course of 10 weeks (5 sessions totaling 20 hours of instruction). It will be taught by subject matter experts from the Emory University faculty and staff as well as potentially from the community. The classes will include the scientific rationale, practical applications, and recommendations for implementing self-care components into participants' daily lives. Experiential learning will include hands-on cooking demonstrations, mindfulness-based lunches, a yoga session, and a group exercise session. Rather than being prescriptive, the lectures and demonstrations are geared to inspire self-designed and personalized alterations in dietary patterns and behaviors that will match participants' culture, preferences, and health conditions. Biometrics and survey instruments will be assessed at 4 times: at baseline, after the 10-week program, and at 6 and 12 months after the program.
16399346|NCT04004442|Drug|Avelumab|Avelumab: 800 mg IV every two weeks (on days 1 and 15 of a 28-day cycle)
16399347|NCT04004442|Drug|AVB-S6-500|AVB-S6-500: 10mg/kg IV every 2 weeks (on days 1 and 15 of a 28-day cycle) Potential dose reduction: AVB-S6-500: 5mg/kg IV weekly (on days 1, 8, 15 and 22 of a 28-day cycle)
16399348|NCT03998319|Drug|Tenecteplase (1/3 systemic weight based dose)|50mg reconstituted to 20mL for intracoronary infusion at 1/3 weight based dose.
16399349|NCT03998319|Other|Sterile water for injection (WFI)|Placebo comparative arm.
16399350|NCT03998319|Drug|Tenecteplase (1/6 systemic weight based dose)|50mg reconstituted to 20mL for intracoronary infusion at 1/6 weight based dose.
16399351|NCT03984448|Drug|Cyclophosphamide|Given IV
16399352|NCT03984448|Drug|Doxorubicin Hydrochloride|Given IV
16399353|NCT03984448|Drug|Etoposide|Given IV
16399354|NCT03984448|Drug|Prednisone|Given PO
16399355|NCT03984448|Biological|Rituximab|Given IV
16399356|NCT03984448|Drug|Venetoclax|Given PO
16399357|NCT03984448|Drug|Vincristine Sulfate|Given IV
16399363|NCT03978780|Procedure|Erector spinae plane block|80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.
16399364|NCT03978780|Procedure|Placebo Block|Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block under ultrasound guidance to stimulate a real block procedure.
16399365|NCT03978104|Dietary Supplement|Okara biscuits|Consumption of okara-enriched biscuits together with habitual diet.
16399366|NCT03978104|Dietary Supplement|Bio-okara biscuits|Consumption of bio-okara-enriched biscuits together with habitual diet. Bio-okara is a form of fermented okara.
16399367|NCT03978104|Dietary Supplement|Control biscuits|Consumption of control biscuits together with habitual diet.
16399368|NCT03970343|Device|OPTIMIZER Smart|"Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:
~Programmable Optimizer Smart Implantable Pulse Generator (IPG)
~OMNI Smart Programmer
~Optimizer Smart Charger
~Two commercially available intravascular leads complete the system."
16399369|NCT03970304|Drug|Vivotif Typhoid Oral Vaccine|The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
16399370|NCT03966053|Drug|Trifluoperazine|Trifluoperazine (TFP)1mg, 2mg, 5mg, or 10mg will be given once daily by mouth for 21 days
16399371|NCT03959241|Procedure|Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate|Mobilized PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.
16399372|NCT03959241|Drug|Tacrolimus|Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting on Day -3. The dose of tacrolimus may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels per institutional guidelines with a suggested range of 5-15. If patients are on medications which alter the metabolism of tacrolimus (e.g.concurrent CYP3A4 inhibitors), the initial starting dose and subsequent doses should be altered as per institutional practices. Tacrolimus taper can be initiated at a minimum of 90 days post HCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices and patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD.
16399373|NCT03959241|Drug|Methotrexate|Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. Methotrexate should be dose reduced, given with leucovorin rescue, or held for complications such as severe mucositis per institutional guidelines.
16399374|NCT03959241|Procedure|Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide|Mobilized PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.
16399375|NCT03959241|Drug|Tacrolimus|Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Starting tacrolimus dose can be modified to account for possible drug interactions (e.g. concurrent CYP3A4 inhibitor use) according to institutional guides. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, and the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at a minimum of 90 days post HCT if there is no evidence of active GVHD. The rate of tapering will be done according to institutional practices but patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD
16399376|NCT03959241|Drug|Mycophenolate Mofetil|MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present.
16399377|NCT03959241|Drug|Cyclophosphamide|Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume).
16399378|NCT03955081|Device|Deep enteroscopy|A deep enteroscopy conducted with the new medical device PowerSpiral.
16399379|NCT03954834|Drug|Tirzepatide|Administered SC
16399380|NCT03954834|Drug|Placebo|Administered SC
16399381|NCT03954067|Biological|ASP9801|Administered by intratumoral injection
16399383|NCT03943550|Drug|RO7049665|Multiple ascending doses of RO7049665 will be administered SC.
16399384|NCT03943550|Drug|Placebo|Matching placebo will be administered SC.
16399385|NCT03943511|Other|Oral Antibiotics-Close Monitoring|To receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve.
16399386|NCT03943511|Other|Standard of Care|No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
16399392|NCT03925961|Other|Preoperative education|The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.
16399395|NCT03910387|Drug|Gemcitabine|Given gemcitabine/nab-paclitaxel combination therapy
16399396|NCT03910387|Drug|Nab-paclitaxel|Given gemcitabine/nab-paclitaxel combination therapy
16399397|NCT03910387|Drug|Telotristat Ethyl|Given PO
16399398|NCT03909503|Device|Porcine-derived collagen wound dressing|Patients who meet the inclusion criteria will be treated with porcine-derived collagen dressings. The dressing will be used in accordance with its label. After cleansing the wound, the dressing will be placed on the wound. Appropriate primary and secondary dressings will be placed over the intervention product. Patients will visit the clinic once per week to have their dressings re-applied. Wound evaluations will take place once per week with the intervention lasting up to twelve weeks. Concomitant standard of care such as compression for venous ulcers will be provided according to individual patient needs.
16399409|NCT03907046|Drug|Apixaban|Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
16399410|NCT03907046|Drug|Aspirin|Aspirin is an oral antiplatelet drug.
16399411|NCT03898180|Biological|Pembrolizumab|IV infusion
16399412|NCT03898180|Drug|Lenvatinib|oral capsule
16399413|NCT03898180|Drug|Placebo for lenvatinib|oral capsule
16399414|NCT03898154|Drug|Dexamethasone|Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone
16399415|NCT03898154|Drug|Methylprednisolone|Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
16399416|NCT03897595|Device|Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head|Hip replacement using Medacts's Mpact cup
16399422|NCT03888716|Drug|KL1333|25 and 100 mg KL1333 encapsulated tablets
16399423|NCT03888716|Drug|Placebo Oral Tablet|25 and 100 mg placebo encapsulated tablets
16399424|NCT03881098|Procedure|Bronchoscopies|"Bronchoscopy: Your nose, throat, vocal cords and windpipe are sprayed with Lidocaine (numbing medicine) to help keep you from coughing and to numb your airways. A tube with either a white light or the fluorescent light (bronchoscopy) is put down through your nose or mouth into your throat. Your nose, throat, vocal cords and lungs will be checked for any unusual areas while the tube goes down. You might have medicine sprayed into your mouth. You may be given a shot into your vein or muscle to help you be more comfortable.
~Endobronchial Biopsy: Very tiny pieces of lung tissue (about the size of the head of a pin) will be taken from the lining of your lungs using forceps and a small brush. These tissues will be taken to a laboratory and tested."
16399425|NCT03881098|Procedure|Sputum Sample|Subjects will be asked to perform the early morning spontaneous cough technique over a six-day period to provide for pre-screening evaluations. If moderate atypia is detected in a pre-screening specimen, additional sputum samples will be collected prior to each subsequent bronchoscopy. If this cannot be performed prior to bronchoscopy with adequate results, the sputum collection may be done after bronchoscopy. The sputum will be collected in containers containing Saccomanno's fixative.
16399426|NCT03881098|Procedure|Venipuncture|Thirty milliliters of blood will be withdrawn from each subject, and the blood will be sent to the biorepository for analysis and storage.
16399431|NCT03875092|Biological|Pembrolizumab|IV infusion
16399432|NCT03875092|Drug|Paclitaxel|IV infusion
16399433|NCT03875092|Drug|Nab-paclitaxel|IV infusion
16399434|NCT03875092|Drug|Carboplatin|IV infusion Carboplatin dose should not exceed 900 mg.
16399435|NCT03875092|Drug|Saline placebo for pembrolizumab|IV infusion
16399439|NCT03862625|Device|a modular adaptive seating system|
16399440|NCT03862625|Other|home exercise program for scoliosis|
16399441|NCT03859973|Drug|BI 425809|Tablet
16399442|NCT03859973|Drug|Placebo|Tablet
16399443|NCT03857087|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
16399444|NCT03857087|Procedure|Magnetic Resonance Imaging (MRI)|Given PET/MRI
16399445|NCT03857087|Procedure|Positron Emission Tomography (PET)|Undergo PET/MRI
16399446|NCT03852693|Other|Histopathological review|Histopathological review
16399447|NCT03847194|Behavioral|Promoting Resilience in Stress Management (PRISM)|PRISM was developed based on stress and coping theory to be a brief, disease non-specific, skills-based intervention targeting adolescent resilience resources. PRISM teaches 4 pillars of resilience including stress management, goal setting, cognitive restructuring and benefit-finding in a one-on-one training program consisting of two, 45-60 minute sessions and supported by 6-months of booster sessions and a fully developed digital app for practice and tracking. A family session follows the individual sessions and was designed for the adolescent to communicate to his/her caregiver(s) the skills learned, and how the caregiver(s) could best support ongoing practice.
16399448|NCT03845140|Drug|L-PZQ ODT|Participants will receive single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
16399449|NCT03845140|Drug|Biltricide®|Participants will receive single oral dose of Biltricide® 40 mg/kg crushed tablet on Day 1.
16399450|NCT03845140|Drug|L-PZQ ODT|Participant will receive single oral dose of L-PZQ ODT 60 mg/kg as decided by the IDMC.
16399451|NCT03843489|Device|MEDLINE RENEWAL PULSE OXIMETRY SENSORS|An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.
16399452|NCT03843489|Device|Reference CO-oximetry sensor|A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
16399453|NCT03836963|Behavioral|cognitive training|Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
16399454|NCT03836963|Behavioral|active control cognitive training|The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
16399455|NCT03836963|Behavioral|memory strategy training|the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
16399456|NCT03836963|Behavioral|memory strategy training|the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
16399457|NCT03828747|Drug|Semorinemab|Participants will receive semorinemab every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. Semorinemab will be administered Q4W in the OLE period.
16399458|NCT03828747|Drug|Placebo|Participants will receive placebo every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period.
16399459|NCT03828747|Drug|[18F]GTP1|[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
16399460|NCT03827447|Drug|Vancomycin Oral Capsule|125 mg capsules every 6 hours for 14 days.
16399461|NCT03827447|Drug|Placebo Oral Capsule|Gelatin pill manufactured to mimic 125 mg Vancomycin oral capsule
16399462|NCT03821077|Biological|Allergen Immunotherapy (AIT)|Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
16399463|NCT03819465|Drug|Durvalumab|Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at C5D1
16399464|NCT03819465|Drug|Danvatirsen|Danvatirsen IV Loading dose C1D1, C1D3, and C1D5 then once a week (q1w) starting at C1D8
16399465|NCT03819465|Drug|Oleclumab|Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at C3D1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at C5D1
16399466|NCT03819465|Drug|MEDI5752|MEDI5752 IV Cohort A: Every 3 weeks (q3w) Cohort B: Every 3 weeks (q3w)
16399467|NCT03819465|Drug|Pemetrexed|Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either q3w or q4w (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter
16399468|NCT03819465|Drug|Carboplatin|Carboplatin IV Day 1 of each 21-day cycle
16399469|NCT03819465|Drug|Gemcitabine|Gemcitabine IV Days 1 and 8 of each 21-day cycle
16399470|NCT03819465|Drug|Cisplatin|Cisplatin IV Day 1 of each 21-day cycle
16399471|NCT03819465|Drug|Nab-paclitaxel|Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle
16399472|NCT03815695|Drug|FT-4202/Placebo|Healthy volunteer subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
16399473|NCT03815695|Drug|FT-4202|Healthy volunteer subjects will receive FT-4202 with or without food and undergo pharmacokinetic studies
16399474|NCT03815695|Drug|FT-4202/Placebo|SCD subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
16399475|NCT03815695|Drug|FT-4202|SCD subjects will receive FT-4202 and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
16399488|NCT03810053|Behavioral|Mobile App/Online Module|Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.
16399497|NCT03792750|Drug|BMS-986205|Specified Dose on Specified Day
16399498|NCT03792750|Biological|Nivolumab|Specified Dose on Specified Day
16399499|NCT03785262|Device|Uroshield|The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
16399500|NCT03785262|Device|Sham Uroshield|The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.
16399501|NCT03777306|Other|ARM A EARLY INTERVENTION GROUP|"Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive
~1 video/picture/worksheet per week covering the topic to be covered.
~1 phone/week by the Health Advisor, to discuss the topic for the week s/as their disease, stress and anxiety management, life organization, adherence skills, healthy eating and sleeping). Participant and the health advisor will also set up a Tiny Step to serve as a goal for the week .
~3 emails/texts through the week, to remind about the topic covered, or to encourage them on their Tiny Step goal.
~After 12 weeks on the program participants will re-take the surveys to assess the level of stress."
16399502|NCT03777306|Other|ARM B DELAYED INTERVENTION GROUP|The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention
16399503|NCT03776630|Other|Blood sample|"Two blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population.
~For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample."
16399504|NCT03775187|Biological|Burosumab|
16399505|NCT03773770|Drug|Triheptanoin|Liquid for oral (PO) or enteral tube administration
16399506|NCT03771664|Drug|SAGE-217|SAGE-217
16399507|NCT03771664|Drug|Placebo|Placebo
16399508|NCT03761069|Drug|PTC299|PTC299 will be administered per the treatment arm description
16399509|NCT03756337|Device|Neuro 1 & Neuro 2|participant common fitting map used for tests
16399510|NCT03756337|Device|Neuro 2 & Neuro 1|participant common fitting map used for tests
16399511|NCT03755128|Other|No intervention|No investigational drugs will be administered as part of the study
16399512|NCT03739983|Device|Vaginal Renewal Program|Therapeutic vibrating wand.
16399513|NCT03736629|Drug|Azithromycin|8 weeks of Azithromycin (250 mg) once daily by mouth
16399514|NCT03736629|Drug|Placebo|Placebo
16399515|NCT03734289|Behavioral|Caregiver Coaching|Online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.
16399518|NCT03730636|Procedure|PCT dosage|Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.
16399519|NCT03727724|Drug|Afatinib|Tablet
16399520|NCT03727724|Drug|Cetuximab|Injection
16399521|NCT03723590|Device|Esterified Hyaluronic Acid Matrix|A non-woven pad composed of esterified hyaluronic acid, covered with a semipermeable silicone layer to protect the wound and control water vapor loss
16399522|NCT03722966|Drug|Varenicline|All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
16399523|NCT03722966|Drug|Oral Nicotine Replacement Therapy (NRT)|Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
16399524|NCT03722966|Behavioral|Medication Reminders|Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
16399525|NCT03722966|Behavioral|Tobacco Cessation Counseling|All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
16399526|NCT03721276|Behavioral|EQuIP (Empowering Queer Identities in Psychotherapy)|Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.
16399527|NCT03715465|Drug|Melatonin 0.5 MG|Melatonin tablet
16399528|NCT03715465|Other|Dim Light Melatonin Onset (salivary)|Test to determine the time of melatonin onset in saliva under dim light conditions
16399534|NCT03697031|Drug|Follitropin Delta|"The Intervention (solution for injection) is delivered with an injection pen. For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight. For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration. The maximum daily dose for the first treatment cycle is 12 micrograms.
~For subsequent treatment cycles, the daily dose of REKOVELLE® should be maintained or modified according to the patient's ovarian response in the previous cycle. Based on the ovarian hypo/hyper-response in the previous cycle, the daily dose in the subsequent cycle should be increased (by 25% or 50%) or decreased (by 20% or 33%). The maximum daily dose is 24 micrograms."
16399535|NCT03691610|Biological|Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine|Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
16399536|NCT03691610|Biological|Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine|Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
16399537|NCT03691610|Biological|Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine|Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
16399538|NCT03691610|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
16399539|NCT03691610|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
16399540|NCT03691610|Biological|Haemophilus b Conjugate Vaccine|Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
16399541|NCT03691610|Biological|Pneumococcal 13-valent Conjugate Vaccine|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
16399542|NCT03691610|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
16399543|NCT03691610|Biological|Hepatitis B Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
16399544|NCT03691610|Biological|Measles, Mumps, and Rubella Virus Vaccine Live|Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
16399545|NCT03691610|Biological|Varicella Virus Vaccine Live|Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
16399546|NCT03665688|Device|Outpatient Dilapan-S|After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L&D unit for standard protocol of labor induction.
16399547|NCT03665688|Device|Inpatient Dilapan-S|"After Dilapan-S placement, subjects will be admitted to L&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain nothing per os (NPO), nothing per vagina and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated."
16399553|NCT03646162|Drug|Veru-944|Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
16399554|NCT03646162|Drug|Placebo|Placebo
16399555|NCT03637764|Drug|Isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16399556|NCT03637764|Drug|Atezolizumab|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16399562|NCT03631446|Drug|Sodium Picosulfate, Magnesium Oxide and Citric Acid|Combination powder for oral solution
16399563|NCT03630835|Other|99mTc-Annexin-V-128 uptake on scintigraphy|"An intravenous catheter will be placed in the forearm and a dose of 370 Mega-Becquerels of 99mTc-Annexin-V-128 (1-2 ml) over 10 seconds will be injected through the catheter. The patient will wait for 90 minutes in semi-supine position for the clearance of the radiotracer from blood. At 90 minutes p.i., the patient will be placed in a supine position on the bed of a SPECT-CT gamma-camera. A SPECT acquisition including the heart and the brain will be performed over 20 minutes. At the end of the SPECT acquisition, the bed will move to the CT of the imaging system. A CT angiography will be acquired during the intravenous injection of 30-40 ml of iodinated CT contrast agent from the heart to the brain to localize the signal on the SPECT images. The iodinated contrast agent that is currently available at Bichat Hospital for CTA is Iomeron 400 provided by Bracco Imaging.
~The total duration of the imaging study will be 2 hours."
16399564|NCT03621670|Biological|Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)|Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.
16399565|NCT03621670|Biological|Prevnar13|Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group
16399566|NCT03621670|Biological|Pediarix|Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
16399567|NCT03621670|Biological|Hiberix|Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
16399568|NCT03621670|Biological|Rotarix|Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
16399569|NCT03621670|Biological|M-M-R II|M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group
16399570|NCT03621670|Biological|Varivax|Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group
16399571|NCT03621670|Biological|Placebo (saline water)|Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group
16399572|NCT03605017|Behavioral|Virtual Reality Executive Function Training (VREFT)|
16399578|NCT03598166|Diagnostic Test|Septin9|Septin9 is a FDA-approved blood test for colorectal cancer screening
16399579|NCT03595280|Behavioral|Hookah tobacco risk messages|Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.
16399580|NCT03588975|Biological|MACI|autologous cultured chondrocytes on porcine collagen membrane
16399581|NCT03588975|Procedure|microfracture|Arthroscopic microfracture treatment
16399582|NCT03580421|Procedure|ambulatory surgery|total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy
16399583|NCT03580421|Procedure|standard surgery|total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy
16399584|NCT03578393|Device|Virtual Reality Educational Program|The study group, in addition to providing the usual information about the anaesthetic-surgical process, will visualize an educational video through virtual reality glasses, of a maximum duration of 5 minutes. The video's explanation will be adapted according to the age ranges. Once the video is finished, if there aren't doubts, the visit will be concluded.
16399585|NCT03570918|Biological|MGD014|HIV-1 x CD3 bispecific DART molecule
16399586|NCT03554473|Drug|M7824|Arm A &amp; B: 2400mg IV over up to 120 minutes every 3 weeks on a 3-week cycle. Arm C: 1200 mg IV over 1 hour every 2 weeks on a 4-week cycle.
16399587|NCT03554473|Drug|Topotecan|Arm B: 1 mg/m2 IV over 30 minutes days 1-5 on a 3-week cycle.
16399588|NCT03554473|Drug|Temozolomide|Arm C and progressive disease patients on Arm A: 200 mg/m2 PO days 1-5 on a 4-week cycle
16399589|NCT03547271|Biological|MenACYW conjugate vaccine|Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular
16399590|NCT03547271|Biological|Meningococcal group A, C, W-135, and Y conjugate vaccine|Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular
16399591|NCT03547271|Biological|DTaP-IPV-HB-Hib vaccine|Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine
16399592|NCT03547271|Biological|Pneumococcal vaccine (13-valent)|Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
16399593|NCT03547271|Biological|Pneumococcal vaccine (10-valent)|Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)
16399594|NCT03547271|Biological|MMR vaccine|Measles, mumps, and rubella vaccine
16399595|NCT03542188|Behavioral|Primary Stroke Center (PSC)|Transport to a primary stroke center for early IV-thrombolysis followed by a secondary transport to a comprehensive stroke center for EVT if needed.
16399596|NCT03542188|Behavioral|Comprehensive Stroke Center (CSC)|Direct transport to a comprehensive stroke center for IV-thrombolysis and early EVT.
16399597|NCT03536728|Drug|AMXT1501|AMXT 1501 dicaprate is D-lys(palmitoyl)-spermine dicaprate salt in 40 mg or 200 mg (free base content) enterically-coated capsules
16399598|NCT03536728|Drug|DFMO|DFMO is DL-2-(difluoromethyl) ornithine monohydrochloride monohydrate 250 mg in hard gelatin capsules
16399599|NCT03520309|Procedure|Dental treatment|Treatment of all dental restorations of the children according to the diagnosis criteria
16399600|NCT03511417|Device|over-the-counter hearing device|Individuals will use commercially-available over-the-counter hearing devices for specified periods of time.
16399721|NCT03156114|Drug|BI 754111|Day 1 of 3 week cycle
16399601|NCT03500419|Device|RestoreX|PTT - Penile traction therapy in the straight position.
16399602|NCT03500419|Other|No treatment|Control group. No treatment will be given for the 6 months post-prostatectomy
16399603|NCT03493945|Biological|M7824|1,200 mg IV once every 2 weeks
16399604|NCT03493945|Drug|N-803|8-15 mcg/kg subcutaneous every 2 weeks
16399605|NCT03493945|Biological|MVA-BN-Brachyury|MVA-BN-Brachyury will be administered subcutaneously (2 doses 2 weeks apart).
16399606|NCT03493945|Biological|FPV-Brachyury|FPV-Brachyury will be given 2 weeks after second dose of MVA-BN-Brachyury, then every 4 weeks until 6 months, then every 3 months for 2 years, then every 6 month.
16399607|NCT03493945|Drug|Epacadostat|600 mg orally twice daily (1200 MG total)
16399608|NCT03493919|Biological|Bexsero|Two doses of Bexsero will be administered on a 0,2-month schedule (Day 1 and Day 61) intramuscularly in the upper deltoid of the non-dominant arm.
16399609|NCT03493919|Biological|Menveo|One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.
16399610|NCT03492164|Drug|[18F]FluorThanatrace ([18F]FTT)|1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one also known as [18F]FluorThanatrace or [18F]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).
16399611|NCT03474497|Drug|IL-2|• A total of four interleukin-2 treatments will be delivered into the treatment lesion by intralesional injection biweekly (at least 48 hours apart) starting 24-96 hours after the completion of radiotherapy and to be completed during the second on-trial cycle of Pembrolizumab. Intralesional injections will be performed by direct visualization and/or palpation of the lesion or under ultrasound or CT guidance as indicated.
16399612|NCT03474497|Drug|Pembrolizumab|Pembrolizumab will be delivered at 200 mg in three week cycles per standard protocol.
16399613|NCT03474497|Radiation|Radiotherapy|Radiotherapy will be delivered to the treatment lesion during the second cycle of therapy using an 8 Gy x 3 fractions palliative regimen. Fractions may be delivered on consecutive or every other day but must be completed during week 1-2 of cycle 2 and will not be repeated in future cycles.
16399614|NCT03472599|Other|Genital Nerve Stimulation|Genital nerve stimulation activates sensory afferents that travel through the pudendal nerves and enters the spinal cord through the sacral dorsal root ganglia. Inhibitory spinal reflex pathways are activated, causing increased sympathetic outflow through the inferior mesenteric ganglion and hypogastric nerve and also decreased parasympathetic efferent drive through the pelvic nerve, resulting in inhibited bladder contractions.
16399615|NCT03469050|Drug|Rifaximin delayed released 400mg Tablet|Rifaximin delayed released
16399616|NCT03469050|Other|Placebo|Placebo BID + Placebo BID
16399617|NCT03466996|Behavioral|Intervention group|More frequent follow up with face to face interaction.
16399618|NCT03466996|Behavioral|Standard of care group|Transition goal setting during annual follow up.
16399619|NCT03461406|Biological|Fibrin Sealant Grifols|human fibrinogen (component 1: 80 mg/mL solution) and human thrombin (component 2: 500 IU/mL solution) solutions filled in syringes and assembled on a syringe holder
16399620|NCT03461406|Biological|EVICEL|1 vial of Biological Active Component 2, a frozen, sterile solution consisting of a concentrate of human fibrinogen (55-85 mg/mL) and 1 vial of thrombin (800-1200 IU/mL)
16399621|NCT03450096|Other|LPB|A bolus injection for LPB of 0.5 ml/kg ropivacaine 3.75 mg/ml (max 40 ml will be performed and the catheter will be placed before surgical interventions. A continuous perineural infusion of 0.2 ml/kg/h ropivacaine 0.2%, starting immediately after initial bolus injection will be then administered
16399622|NCT03449680|Procedure|Femoral Articular Branch Block|Slow injection (3mL aliquots) of local anesthetic solution (20ml of Ropivacaine 0.5%) into the fascia above the iliopsoas muscle (located in the groove between the two bony landmarks - (1)anterior inferior iliac crest and (2)iliopubic eminence).This is done by ultrasound guidance.
16399623|NCT03449680|Procedure|Placebo Block|Subcutaneous injection of 1ml normal sterile saline
16399624|NCT03449381|Drug|BI 907828|Film-coated tablet
16399625|NCT03438032|Diagnostic Test|Bronchoscopy with lavage|During an elective bronchoscopy procedure, the bronchoscope will be wedged into an affected lung segment guided by CT scanning. When involved an anterior segment will be used to maximize return. After wedging the bronchoscope, 120ml of sterile 0.09% normal saline will be instilled. Up to 40-60 mL of BAL fluid will be obtained for analysis during each sampling.
16399626|NCT03427047|Device|MyKnee with single use Efficiency Instrument|Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
16399627|NCT03427047|Device|Stryker Navigational with conventional metal instruments|Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
16399628|NCT03421353|Drug|AZD9150|"AZD9150 will be administered as a 1-hour intravenous infusion either weekly (QW) or every two weeks (Q2W), depending on which arm the patient is enrolled in.
~AZD9150 will be provided as a liquid drug product in clear glass vials. Each vial will be labelled in accordance with GMP Annex 13 and per country regulatory requirement."
16399629|NCT03421353|Drug|Durvalumab|"Durvalumab will be administered as a 1-hour intravenous infusion either every three weeks (Q3W) or every four weeks (Q4W), depending on which arm the patient is enrolled in.
~Durvalumab will be provided as a solution in clear glass vials. Each vial will be labelled in accordance with GMP Annex 13 and per country regulatory requirement."
16399630|NCT03421353|Drug|Cisplatin|Cisplatin will be infused over 30-60 minutes on Day 1.
16399631|NCT03421353|Drug|5-Flourouracil|5-flourouracil will be continuously infused over Days 1 to 4 every three weeks for up to 18 weeks.
16399632|NCT03421353|Drug|Carboplatin|Carboplatin will be infused over 30 to 60 minutes on Days 1, 8, and 15, depending on which arm the patient is enrolled in, for up to 18 weeks.
16399633|NCT03421353|Drug|Gemcitabine|Gemcitabine will be infused over 30 minutes on Days 1 and 8 for up to 18 weeks.
16399634|NCT03421353|Drug|Nab-paclitaxel|Nab-paclitaxel will be infused over 30 to 40 minutes on Days 1, 8, and 15 for up to 18 weeks.
16399635|NCT03405792|Drug|Temozolomide (TMZ)|Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity.
16399636|NCT03405792|Device|Optune System|Patients will undergo 24-months of planned treatment with Optune therapy.
16399637|NCT03405792|Drug|Pembrolizumab|Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.
16399638|NCT03399578|Biological|ChAdOx1 MERS|The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.
16399639|NCT03399513|Drug|Ibrutinib Oral Capsule [Imbruvica]|Imbruvica 140 mg hard capsules (Active substance: Ibrutinib)
16399640|NCT03399513|Drug|R-CHOEP chemotherapy|Immunochemotherapy
16399641|NCT03383211|Other|RNAseq|Transcriptome profiling of peripheral blood using RNA sequencing technology
16399642|NCT03382769|Device|Cochlear implantation|Unilateral implantation with a commercially approved Nucleus cochlear implant
16399649|NCT03368014|Behavioral|Lyrics-writing and singing show|"Participants will participate in a Lyrics-Writing and Singing Competition. They will first attend a lyrics-writing workshop and a short talk on SME (Sharing, Mind, Enjoyment) focusing on praising family members and knowledge of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; submit SME (Sharing, Mind, Enjoyment) worksheet, such as Express Your Love to Family Member after the workshops; participate in the SME (Sharing, Mind, Enjoyment) Lyrics-writing and Singing Show and Award Ceremony (sharing) with a live performance by awarded entries and prize presentation ceremony."
16399650|NCT03367819|Drug|Isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16399651|NCT03367819|Drug|Cemiplimab REGN2810|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16399652|NCT03361462|Behavioral|Joyful Adventure Day|"Participants will participate in two joyful adventure days with adventure games and a short talk on SME (Sharing, Mind, Enjoyment) focusing on positive thinking and understanding of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; provide physical activity diary, such as Zero-time Exercise after 1st session of adventure day, and invite family members / peers to join the competition at the 2nd session."
16399653|NCT03348631|Other|Laboratory Biomarker Analysis|Correlative studies
16399654|NCT03348631|Drug|Tazemetostat|Given PO
16399655|NCT03343236|Radiation|Radiotherapy|All patients will undergo radiotherapy or surgery, or combined modality treatment
16399656|NCT03331341|Drug|Dacarbazine|Given IV
16399657|NCT03331341|Drug|Doxorubicin Hydrochloride|Given IV
16399658|NCT03331341|Other|Laboratory Biomarker Analysis|Correlative studies
16399659|NCT03331341|Biological|Pembrolizumab|Given IV
16399660|NCT03331341|Drug|Vinblastine|Given IV
16399661|NCT03321747|Radiation|Stereotactic Ablative Body Radiation (SABR)|Treatments shall not be delivered more frequently than every other day.
16399666|NCT03303950|Drug|Busulfan|Given IV
16399667|NCT03303950|Drug|Cyclophosphamide|Given IV
16399668|NCT03303950|Drug|Fludarabine|Given IV
16399669|NCT03303950|Procedure|Hematopoietic Cell Transplantation|Undergo HSCT
16399670|NCT03303950|Other|Laboratory Biomarker Analysis|Correlative studies
16399671|NCT03301909|Device|PillCam™ Endoscopy System|Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.
16399672|NCT03301909|Drug|Bowel prep combination|Subject may be assigned to any bowel preparation combination.
16399673|NCT03295500|Radiation|Dose fraction forms|The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.
16399674|NCT03290287|Drug|Aclidinium bromide|Administered as monotherapy, concomitant with formoterol not in fixed-dose combination, or fixed-dose aclidinium/formoterol
16399675|NCT03290287|Drug|Other COPD medication|"Users of the following COPD medications:
~Tiotropium
~Other long-acting anticholinergic (LAMAs): glycopyrronium bromide, umeclidinium
~LABA: formoterol, salmeterol, indacaterol
~LABA/ICS (LABA in fixed-dose combinations with ICS): formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone, and vilanterol/fluticasone.
~LAMA/LABA (approved or under regulatory review or in development): glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol"
16399676|NCT03288766|Procedure|PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software|The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.
16399677|NCT03275831|Device|PluroGel|Surfactant based gel
16399678|NCT03275831|Device|Intrasite gel|Hydrogel
16399722|NCT03156114|Drug|BI 754091|Day 1 of 3 week cycle
16399723|NCT03152539|Radiation|MRI|
16399724|NCT03152539|Device|EEG|
16399725|NCT03152539|Device|NIRS|
16399776|NCT02948959|Drug|Placebo|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
16399679|NCT03263559|Procedure|Haploidentical Bone Marrow Transplantation|Eligible patients with a first degree Human Leukocyte Antigen (HLA)- haploidentical donor will undergo Haploidentical bone marrow transplantation at Day 0 with non T-cell depleted bone marrow. For Graft-vs-Host Disease (GVHD) prophylaxis, patients will be given sirolimus and mycophenolate mofetil beginning on Day +5.
16399680|NCT03263559|Drug|Hydroxyurea|HU will be given daily at 30mg/kg from Day -70 through Day -10.
16399681|NCT03263559|Drug|Rabbit-ATG|Rabbit-ATG (rATG) will be given at 0.5mg/kg on Day -9, and at 2.0mg/kg on Day -8 and Day -7.
16399682|NCT03263559|Drug|Thiotepa|Thiotepa will be given at 10mg/kg on Day -7
16399683|NCT03263559|Drug|Fludarabine|Fludarabine will be given at 30mg/m2 from Day -6 to Day -2
16399684|NCT03263559|Drug|Cyclophosphamide|Cyclophosphamide will be given at 14.5mg/kg on Day -6 and Day -5, and at 50 mg/kg on Days +3 and +4.
16399685|NCT03263559|Radiation|Total Body Irradiation|Total Body Irradiation will be given at 200cGy on Day -1
16399686|NCT03263559|Drug|Mesna|Mesna will be given at 40mg/kg on Days +3 and +4
16399687|NCT03256097|Device|XDP sound processing strategy - Period 0|XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
16399688|NCT03256097|Device|XDP sound processing strategy - Period 1|XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
16399689|NCT03256097|Device|VG sound processing strategy - Period 1|Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
16399690|NCT03256097|Device|XDP sound processing strategy - Period 2|XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
16399691|NCT03256097|Device|VG sound processing strategy - Period 2|Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
16399692|NCT03256097|Device|XDP sound processing strategy - Period 3|XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
16399693|NCT03256097|Device|VG sound processing strategy - Period 3|Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
16399694|NCT03256097|Device|Voice Track|Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants
16399695|NCT03245372|Procedure|Standard care|Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation).
16399696|NCT03245372|Procedure|Goal directed therapy|The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
16399697|NCT03240692|Device|Accelerated theta-burst stimulation treatment|"All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system."
16399698|NCT03239340|Drug|Osimertinib|Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR.
16399700|NCT03230032|Device|pacifier-activated device|The utilization of the pacifier-activated-music player combines the sound of the mother's voice with a pacifier routinely used with each patient during their inpatient NICU stay
16399702|NCT03211663|Device|MOTO Medial® UKA|Knee replacement surgery with the MOTO Medial® UKA
16399710|NCT03191149|Drug|Osimertinib|Given PO
16399711|NCT03189706|Drug|Irinotecan|50mg/m^2/day IV will be administered from day 1-5
16399712|NCT03189706|Drug|temozolomide|(given concurrently with Irinotecan) 150mg/m^2/day orally
16399713|NCT03189706|Biological|Hu3F8|2.25mg/kg IV will be administered on days 2, 4, 8 and 10
16399714|NCT03189706|Drug|GM-CSF|250mcg/m2/day SC will be administered on days 6-10
16399715|NCT03168750|Device|Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.|Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.
16399716|NCT03160235|Radiation|Magnetic resonance imaging|
16399717|NCT03160235|Device|EEG|
16399718|NCT03160235|Device|NIRS|
16399719|NCT03158883|Drug|Avelumab|Avelumab: 10 mg/kg administered by IV infusion q2w (1 cycle = 14 [±2] days).
16399720|NCT03158883|Radiation|Stereotactic ablative radiotherapy (SAR)|SAR: the prescription dose will be 50 Gy over 5 fractions of 10 Gy each on an every 2 day basis (i.e., 2-3 treatments per week, with a minimum of 40 hours and a maximum of 96 hours between treatments) and completed within 1.5-2 weeks. SAR treatment will not be repeated.
16399726|NCT03148379|Device|Customized patient instruments|Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
16399727|NCT03148379|Device|Traditional Metal Instruments|Traditional metal instrument will be used to make bone cuts and size the components in this control group.
16399728|NCT03118531|Device|Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)|The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.
16399729|NCT03113994|Drug|Rosuvastatin Calcium|10mg Rosuvastatin, daily for 12 months
16399730|NCT03113994|Drug|Placebo Oral Tablet|Placebo, daily for 12 months
16399731|NCT03113994|Dietary Supplement|Coenzyme Q10|100mg CoQ10, daily for 12 months
16399732|NCT03113994|Dietary Supplement|Calcium Carbonate|1250mg Calcium Carbonate, daily for 12 months
16399733|NCT03113994|Dietary Supplement|Vitamin D|2000IU Vitamin D, daily for 12 months
16399734|NCT03082209|Drug|ABBV-621|Intravenous (IV)
16399735|NCT03082209|Drug|Venetoclax|tablet, oral
16399736|NCT03082209|Drug|Bevacizumab|IV infusion
16399737|NCT03082209|Drug|FOLFIRI|IV infusion
16399738|NCT03081806|Drug|X0002|Subjects will complete 22 weeks of double-blind treatment and then enter into 30 weeks open-label treatment.
16399739|NCT03068416|Biological|CAR T cells|Autologous CD19-targeting, 3rd generation CAR T cells
16399740|NCT03040804|Radiation|Low dose Radiotherapy|Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.
16399741|NCT03033914|Drug|doxorubicin|Doxorubicin: 25 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
16399742|NCT03033914|Drug|Bleomycin|Bleomycin: 10 units/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
16399743|NCT03033914|Drug|vinblastine|Vinblastine: 6 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
16399744|NCT03033914|Drug|dacarbazine|Dacarbazine (DTIC): 375 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
16399745|NCT03033914|Drug|Nivolumab|nivolumab 240mg q14 days
16399746|NCT03029208|Drug|Daprodustat|Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.
16399747|NCT03029208|Drug|Darbepoetin alfa|Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.
16399748|NCT03029208|Drug|Iron therapy|Iron therapy will be administered if ferritin is <=100 ng/mL and/or TSAT is <=20%.
16399749|NCT03022383|Device|DRI OCT Triton plus|OCT Machine used for diagnostic purposes
16399750|NCT03008278|Drug|Olaparib|Give PO
16399751|NCT03008278|Biological|Ramucirumab|Given IV
16399752|NCT03002415|Other|Guided water intake|"Verbal and written guidelines will be given for the patient to ingest the daily volume of water calculated by the weight (30 ml / kg / day) for 14 days. Patients will receive an acrylic glass with a mark in 200 ml and will be instructed to take the number of glasses a day corresponding to the calculated volume (30 ml / kg). Patients will also receive a leaflet indicating how many glasses of water they will need to take. They will also be instructed to mark with an X the number of glasses of water that they actually drank daily during the fourteen days of intervention."
16399753|NCT03002415|Other|Placebo - free demand water intake|Patients are instructed to drink water and other liquids on demand. Patients are asked to note on a food record food and liquids and quantities consumed throughout the day. Patients are advised to make a four-day food diary out of the 14 days.
16399761|NCT02991027|Device|DRI OCT Triton|DRI OCT Triton using micro-electro-mechanical short cavity tunable laser
16399762|NCT02991027|Device|DRI OCT Triton|DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser
16399763|NCT02990897|Behavioral|clinical decision support message|The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.
16399764|NCT02987582|Behavioral|Emotion-focused mindfulness group|Intervention The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week; groups will run between October 2016 and June 2018.
16399765|NCT02982174|Device|3D OCT-1 Maestro|Image acquisition of the posterior surface of the eye
16399766|NCT02982174|Device|DRI OCT Triton|Image acquisition of the posterior surface of the eye
16399767|NCT02980887|Other|No Intervention|There is no intervention in this observational study
16399768|NCT02972944|Procedure|Laparoscopic cholecystectomy|
16399769|NCT02972944|Procedure|Non-operative treatment|
16399770|NCT02971956|Drug|Pembrolizumab|Immune checkpoint inhibitor
16399771|NCT02969512|Other|HIPPER|Participants can complete the online educational modules at home or another location with internet access. The total time to complete all of the modules is about 2 hours and 30 minutes.
16399772|NCT02969512|Other|OASIS Online Educational Webinars|2-hour online educational large group sessions
16399773|NCT02964546|Other|Blood sample|2 additional tubes of blood samples are collected during a blood sample realized for the patient's care
16399774|NCT02960568|Drug|Primaquine|30 mg oral primaquine one time
16399775|NCT02948959|Drug|Dupilumab|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
16399852|NCT02693535|Drug|Crizotinib|drug
16399777|NCT02948959|Drug|Asthma Controller Therapies|"Pharmaceutical form: Aerosol, capsules, tablets, oral solution
~Route of administration: Inhaled, oral"
16399778|NCT02948959|Drug|Asthma Reliever Therapies|"Pharmaceutical form: Nebulized, aerosol
~Route of administration: Inhaled"
16399779|NCT02948790|Device|Neuristim|Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
16399780|NCT02948790|Device|Cochlear implant|Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
16399781|NCT02923544|Procedure|YUMI manipulator|
16399782|NCT02921789|Drug|Bleselumab|Intravenous infusion
16399783|NCT02921789|Drug|Basiliximab|Bolus injections
16399784|NCT02921789|Drug|Mycophenolate Mofetil (MMF)|Oral (po) or intravenous (iv) two times a day (bid)
16399785|NCT02921789|Drug|Tacrolimus Capsules|Oral (po) or intravenous (iv) if medically indicated
16399786|NCT02921789|Drug|Methylprednisone|Oral (po) or intravenous (iv)
16399787|NCT02921789|Drug|Prednisone|Oral (po)
16399788|NCT02920866|Behavioral|Functional Strength Integration (FSI)|FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
16399789|NCT02920866|Behavioral|Control Group (CON)|Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.
16399790|NCT02917122|Device|active tDCS|Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.
16399791|NCT02917122|Drug|Sertraline|Patients will take Sertraline.
16399792|NCT02917122|Device|sham tDCS|Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.
16399799|NCT02912351|Other|Patient record review, Radiographs, and questionaires.|KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction
16399800|NCT02902107|Device|CivaSheet|
16399801|NCT02902107|Radiation|Brachytherapy|
16399802|NCT02902107|Procedure|surgical resection|
16399803|NCT02899052|Drug|Carfilzomib|"Carfilzomib lyophilized administered intravenously as a 10 to 30 minute infusion in Cycles 1 and beyond within 30 minutes to 4 hours after dexamethasone dosing.
~Dose level 1 (K1) Cycle 1: 20 mg/m2 on Days 1 and 2, 27 mg/m2 on Days 8, 9, 15, and 16; Cycles 2 - 12: 27 mg/m2 on Days 1, 2, 8, 9, 15, and 16; Cycles 13 - 18: 27 mg/m2 on Days 1, 2, 15, and 16; Cycles 19 and beyond, for participants that have not previously transitioned to monotherapy: 27 mg/m2 on Days 1, 2, 15, and 16.
~Dose Level K2: Cycle 1: 20 mg/m2 on Day 1; 70 mg/m2 on Days 8 and 15 Cycles 2 - onward: 70 mg/m2 on Days 1, 8, and 15. Dose Level K3: Cycle 1: 20 mg/m2 on Days 1 and 2; 56 mg/m2 on Days 8, 9, 15, and 16.
~Cycles 2 - onward: 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16."
16399804|NCT02899052|Drug|Venetoclax|Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.
16399805|NCT02899052|Drug|Dexamethasone|Dexamethasone tablet administered orally during Cycles 1 - onward. Dexamethasone dose level 1 (Dex1) 40 mg once weekly, Dex2 40 mg once weekly, Dex3 20 mg twice weekly.
16399806|NCT02895945|Biological|Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)|In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures.
16399809|NCT02864004|Drug|Apomorphine|Apomorphine (5 mg/ml) is supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate is adjusted during the whole duration of the study to doses of minimum 3 mg/hour up to a maximum of 10 mg/hour
16399810|NCT02864004|Other|Best Medical Treatment|Most efficient single treatment of Parkinson's disease symptoms or their combinations, in concordance with the guidelines of the European Federation of Neurological Societies
16399811|NCT02860091|Drug|Ropivacaine infusion|Delivered via paravertebral nerve block catheter.
16399853|NCT02693535|Drug|Palbociclib|drug
16399854|NCT02693535|Drug|Sunitinib|drug
16399855|NCT02693535|Drug|Temsirolimus|drug
16399856|NCT02693535|Drug|Trastuzumab and Pertuzumab|drug
16399857|NCT02693535|Drug|Vemurafenib and Cobimetinib|drug
16399858|NCT02693535|Drug|Regorafenib|drug
16399859|NCT02693535|Drug|Olaparib|drug
16399860|NCT02693535|Drug|Pembrolizumab|drug
16399815|NCT02845947|Behavioral|Music Therapy|The music therapy intervention offered during the time of the patient's extubation readiness trial (ERT) will consist of live music using a multitude of instruments and patient-preferred and improvised music. The music therapy interventions will always include the use of live music, including guitar, keyboard, voice, ocean drum, reverie harp, and/or various percussive instruments. The music therapist will use a tablet to understand how to play patient-preferred songs. To ensure patient safety, the music therapist will adhere to the infection control policies set forth by the institution. The following are the intended goals of the Music therapy intervention: facilitating relaxation, alleviation of anxiety, and successful utilization of new coping skills.
16399816|NCT02834403|Drug|L-NMMA|Nitric oxide synthase inhibitor
16399817|NCT02834403|Drug|Docetaxel|Mitotic inhibitor, cytotoxic
16399818|NCT02834403|Drug|Amlodipine|Long-acting calcium channel blocker
16399819|NCT02834403|Drug|Pegfilgrastim|Colony-stimulating factor
16399820|NCT02834403|Drug|Enteric-coated aspirin|non-steroidal anti-inflammatory drug
16399821|NCT02828761|Device|Coronary Calcium Scoring|Scan with 64-detector row or better CT scanners with quantification by the Agatston method.
16399822|NCT02828761|Procedure|Standard Care|Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.
16399823|NCT02811601|Procedure|PEAL surgery|Patients will undergo percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars.
16399824|NCT02793492|Device|Misago® RX Self-expanding Peripheral Stent|the Misago® RX Self-expanding Stent is a bare metal, nitinol stent
16399825|NCT02770040|Drug|Infliximab|INFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused
16399826|NCT02766465|Drug|Busulfan|"A:
~Busulfan dose will be 3.2 mg/kg administered as a single daily dose IV on days -8 through -5 with dosing adjusted using targeted pharmacokinetics."
16399827|NCT02766465|Drug|Fludarabine|"A:
~Fludarabine dose will be 35 mg/m^2/day administered IV on days -7 through -3 (total fludarabine dose is 175 mg/m^2).
~C:
~Fludarabine 30mg/m2 IV dose will be given on Days -8, -7, -6, -5, -4"
16399828|NCT02766465|Drug|r-ATG|"A:
~r-ATG will be administered IV on day -6 at 0.5mg/kg, on day -5 at 1 mg/kg and on days -4, -3 and -2 at 1.5mg/kg (total r-ATG dose is 6 mg/kg)."
16399829|NCT02766465|Procedure|Hematopoietic Cell Transplant|"A,B,C:
~Day 0 is the day of transplantation."
16399830|NCT02766465|Drug|Tacrolimus|"A:
~Tacrolimus commences on day -3 and extends through day +180 after transplantation with doses adjusted to maintain appropriate levels according to institutional guidelines.
~C:
~Tacrolimus at therapeutic doses through Day 180, then taper per institutional guidelines"
16399831|NCT02766465|Drug|Methotrexate|"A:
~Methotrexate will be administered intravenously on day+1 at 15mg/m^2, day+3 at 10mg/m^2, day+6 at 10mg/m^2, and day+11 at 10mg/m^2.
~C:
~Methotrexate IV 7.5 mg/m2 dose will be given on Days +1, 3, +6 following transplant"
16399832|NCT02766465|Procedure|Standard of Care|Continue to receive standard of care treatment per patient's SCD physician.
16399833|NCT02766465|Drug|Alemtuzumab|"B:
~Alemtuzumab 0.03 mg/kg IV dose will be given on Day -7, Alemtuzumab 0.1 mg/kg IV dose will be given on Day -6, Alemtuzumab 0.3 mg/kg IV dose will be given on Day -5,-4,-3
~C:
~Alemtuzumab test dose 3 mg IV once 24 hours prior to 1st dose of Alemtuzumab Alemtuzumab 10 mg IV, 15 mg IV, 20 mg IV given on Days -22 through Day -18. Alemtuzumab doses may be administered between Days -22 and -18 but are required to be on three consecutive days."
16399834|NCT02766465|Drug|Total Body Irradiation (TBI)|Total Body Irradiation 300 cGY on Day -2
16399835|NCT02766465|Drug|Sirolimus|Sirolimus at therapeutic doses through day 180, then taper per institutional guidelines if donor CD3+ >50%
16399836|NCT02766465|Drug|Melphalan|"C:
~Melphalan 140 mg/m2 IV dose will be given on Day -3"
16399837|NCT02766465|Drug|G-CSF|G-CSF 5 μg/kg/day continue until neutrophil engraftment.
16399838|NCT02761694|Drug|Vevorisertib|During dose escalation, subjects received vevorisertib orally every day at dose levels specified for the respective dose cohort for a 28-day cycle During dose expansion, subjects will receive vevorisertib orally at 75mg every day on a 28-day cycle.
16399839|NCT02761694|Drug|Vevorisertib and Fulvestrant|Subjects will receive vevorisertib orally every day at dose levels specified for the respective dose cohort for a 28-day cycle in combination with fulvestrant (500 mg administered intramuscularly) on Days 1 & 15 of Cycle 1 and Day 1 on all subsequent cycles for each 28-day cycle.
16399840|NCT02761694|Drug|Vevorisertib and Paclitaxel|Vevorisertib will be administered every day orally at dose levels specified for the respective dose cohort for a 28-day cycle in combination with an intravenous (IV) infusion of paclitaxel (80 mg/m2), once a week on Day 1, 8 &15 for three consecutive weeks followed by one week off of each 28-day cycle.
16399841|NCT02748018|Device|670G and 770G Insulin Pump|Medtronic 670G and 770G Hybrid Closed Loop Systems
16399842|NCT02748018|Device|Subject's Current Diabetes Therapy|Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
16399843|NCT02741128|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
16399844|NCT02741128|Biological|Placebo (NaCl 0.9%) vaccine group|0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
16399847|NCT02712112|Drug|Imatinib Mesylate|
16399848|NCT02706392|Other|Laboratory Biomarker Analysis|Correlative studies
16399849|NCT02706392|Biological|ROR1 CAR-specific Autologous T-Lymphocytes|Given IV
16399850|NCT02701088|Drug|5Fluorouracile and Mitomycin-C|All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29).
16399851|NCT02701088|Radiation|Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy|SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes.
16399861|NCT02693535|Drug|Nivolumab and Ipilimumab|drug
16399862|NCT02693535|Drug|Abemaciclib|drug
16399863|NCT02693535|Drug|Afatinib|drug
16399864|NCT02693535|Drug|Talazoparib|drug
16399865|NCT02693535|Drug|Atezolizumab and PHESGO|drug
16399866|NCT02693535|Drug|Atezolizumab and Talazoparib|drug
16399867|NCT02693535|Drug|Entrectinib|drug
16399868|NCT02693535|Drug|Larotrectinib|drug
16399869|NCT02693535|Drug|Tucatinib plus Trastuzumab Subcutaneous (SC)|drug
16399874|NCT02664597|Procedure|ADNEXMR Scoring System|Patients will undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium injection) and functional sequences (perfusion and diffusion-weighted sequences). Prospectively, a senior radiologist analyzes the different MR criteria to characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score
16399875|NCT02664597|Other|Standard strategy|In control group, the complex adnexal mass will be managed according to the standard strategy and treatment plan routinely used by the multidisciplinary team.
16399876|NCT02662881|Device|PerFuse Percutaneous Decompression System|Core decompression with PerFuse
16399877|NCT02662881|Device|BioCUE Platelet Concentration System|PRP injection through the PerFuse cannula into core decompression site
16399878|NCT02640690|Behavioral|Trauma Sensitive Yoga Intervention|(10) 1-hour sessions of trauma sensitive yoga
16399879|NCT02640690|Behavioral|Cognitive Processing Therapy-Cognitive Only|(12) 1.5 hour sessions of cognitive processing therapy
16399880|NCT02634411|Drug|8 days of effective antibiotic treatment|"Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive).
~Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 8 days."
16399881|NCT02634411|Drug|15 days of effective antibiotic treatment|"Antibiotics used for usual care in PA-VAP treatment : Penicillins, Cephalosporins, Monobactams, Carbapenems, Fluoroquinolones, Aminoglycosides (list not exhaustive).
~Antibiotic treatment should be started just after realization of bacteriological sampling, and then converted into a narrow-spectrum therapy, based on culture results, for a total duration of effective antibiotic therapy against pseudomona aeruginosa of 15 days."
16399882|NCT02633241|Drug|Dexmedetomidine bolus and infusion-Propofol|First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 0.5mcg/kg/hour. At the 5 minute point, propofol will be given (2-3mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.
16399883|NCT02633241|Drug|Dexmedetomidine bolus only - Propofol|First, the investigators will begin by administering dexmedetomidine 1mcg/kg over 5 minutes. When this is completed, they will administer propofol 2-3mg/kg titrated bolus followed by 100mcg/kg/min infusion which can also be titrated up or down to a maximum of 300mcg/kg/min to keep the blood pressure and heart rate within 30% of baseline levels.
16399884|NCT02633085|Device|Fixed Bearing or Mobile Bearing UKA|Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.
16399885|NCT02624765|Drug|Digoxin (monotherapy)|Oral or IV loading dose: 0.5 mg q 12 h (total 4 doses over 48 hours) followed by Oral maintenance dose: 0.25 mg-1mg/day
16399886|NCT02624765|Drug|Sotalol (monotherapy)|Oral dose: 80 mg TID or 120 mg BID (240 mg/day)
16399887|NCT02624765|Drug|Flecainide (monotherapy)|Oral dose: 100 mg TID (300 mg/day)
16399888|NCT02624765|Drug|Digoxin (dual therapy)|Oral or IV loading dose: 0.5 mg q 8 h (total 4 doses over 32 hours) followed by oral maintenance dose: 0.25 mg-1mg/day
16399889|NCT02624765|Drug|Sotalol (dual therapy)|Oral dose: 160 mg BID (320 mg/day)
16399890|NCT02624765|Drug|Flecainide (dual therapy)|Oral dose:100 mg TID (300 mg/day)
16399891|NCT02619253|Drug|Pembrolizumab|
16399892|NCT02619253|Drug|Vorinostat|
16399893|NCT02605564|Other|Gluten Free Diet|Gluten Free Diet
16399894|NCT02605564|Other|Placebo|Placebo No intervention, standard T1DM diet
16399895|NCT02591082|Device|RenovoCath™ R120 Catheter|The RenovoCath™ RC120 Catheter will be used to isolate segments of arteries supplying blood to the pancreas. The two balloons on the catheter will be positioned and inflated to temporarily stop blood flow while medication is infused through the catheter between the balloons.
16399896|NCT02583113|Device|Total and Unicompartment Knee Replacement|Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.
16399897|NCT02582619|Other|Focus groups, semistructured interviews and Delphi rounds|
16399898|NCT02557139|Drug|Belumosudil Tablet|
16399899|NCT02557139|Drug|Belumosudil Capsule|
16399901|NCT02554383|Drug|Amoxicillin-clavulanate|Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
16399902|NCT02554383|Drug|Placebo|placebo made to match the study antibiotic given twice a day orally for 10 days
16399903|NCT02553954|Procedure|Collection of healthy skin tissue|Collection of two samples of healthy skin tissue, without disfigurement, during an intervention under general anesthesia for the treatment of a benign or malignant tumor.
16399904|NCT02511106|Drug|AZD9291 80 mg/40 mg|The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
16399905|NCT02511106|Drug|Placebo AZD9291 80 mg/40 mg|The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
16399906|NCT02511106|Drug|Open-label AZD9291 80 mg/40 mg|Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
16399907|NCT02510300|Drug|Sofosbuvir (SOF)|Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
16399908|NCT02510300|Drug|Ledipasvir/Sofosbuvir (LDV/SOF)|Exposure of interest for participants who received a LDV/SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
16399909|NCT02510300|Drug|Sofosbuvir/Velpatasvir (SOF/VEL)|Exposure of interest for participants who received a SOF/VEL-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
16399910|NCT02510300|Drug|Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)|Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
16399919|NCT02501733|Device|Medacta GMK Sphere® Medial Knee Prosthesis|"There is no consensus within the Arthroplasty community as to whether a traditional post and cam-style Posterior Stabilized total knee device is superior to a medial-pivot, more congruent device. However, the majority of surgeons seem to prefer the former, though there is a minority that uses the latter device with great success.
~To date, there have been few prospective trials directly comparing these devices, and none with the latest generation of Total Knee Arthroplasty implants. Almost all such studies have been retrospective and/or utilizing older generation devices."
16399925|NCT02477358|Procedure|Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone|All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy will be applied to the left tooth socket only. The right tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
16399926|NCT02477358|Procedure|Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone|All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy to the right tooth socket only. The left tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
16399938|NCT02347410|Device|SIFS graft containment device|The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
16399939|NCT02332577|Drug|PRISTINAMYCIN XRP7263|Pharmaceutical form:tablet 500 mg Route of administration: oral
16399940|NCT02332577|Drug|Amoxicillin|Pharmaceutical form:capsule 500 mg Route of administration: oral
16399941|NCT02332577|Drug|Amoxicillin Placebo|Pharmaceutical form: capsule Route of administration: oral
16399942|NCT02332577|Drug|PRISTINAMYCIN Placebo|Pharmaceutical form:Tablet Route of administration: Oral
16399943|NCT02315898|Drug|Treatment-inhaled tPA|Enrolled patients with acute plastic bronchitis (fibrin airway casts) will receive inhaled tPA treatment. The tPA regimen will consist of 5mg every six hours for a total of 72 hours.
16399944|NCT02255383|Device|Zimmer Persona Total Knee System|Primary Total Knee Arthroplasty
16399945|NCT02221817|Procedure|Trochanter bursa injections|
16399946|NCT02221817|Device|Ultrasound|
16399947|NCT02218164|Drug|Pegylated Interferon alpha-2b|Drug administration will occur on an outpatient basis at the infusion center at Moffitt Cancer Center. Dose will be weight-based. Starting treatment doses of 3 mcg/kg will be given subcutaneously (SC) injection in the thigh, abdominal wall, or upper arm every week for a total of 27 weeks as tolerated.
16399948|NCT02218164|Drug|Capecitabine|Drug administration will be on an outpatient basis. Capecitabine will be administered at an initial dose of 800 mg/m^2 by mouth twice daily on days 1-14 of a 21 day cycle with days 15-21 off. This cycle will be repeated every 21 days during the study for a maximum of 9 cycles as tolerated. Administration via feeding tube in patients unable to swallow is permitted.
16400001|NCT01720173|Other|Laboratory Biomarker Analysis|Correlative studies
16400002|NCT01665144|Drug|BAF312|0.25, 0.5, 1, and 2 mg film-coated tablets
16400003|NCT01665144|Drug|Placebo|Film-coated tablets
16400261|NCT05087030|Drug|RGB-14-P|Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
16399949|NCT02218164|Drug|5-FU|If participants are not able to acquire oral capecitabine, then treating physicians will start participants on infusional 5-FU which can be delivered via standard of care. Participants will need to have a port placed for continuous infusion treatments. 5-FU pumps will be activated in the infusion center at Moffitt Cancer Center with a starting dose of 800 mg/m^2 days 1-4, with pump removal on day 5 at the infusion center. 5-FU pumps will be attached every 21 days (1 cycle) for a maximum of 9 cycles.
16399950|NCT02203682|Drug|Doxycycline hyclate|Tab. Doxycycline 50 mg PO per day for 12 weeks
16399951|NCT02203682|Drug|Placebo|Tablet placebo for 12 weeks
16399952|NCT02173990|Drug|Aflibercept-FOLFIRI|"Aflibercept : 4 mg/kg, IV over 1 h on Day 1
~FOLFIRI :
~Irinotecan 180 mg/m² IV infusion in 500 mL D5W (5% Dextrose in Water solution) over 90 minutes and dl leucovorin* 400 mg/m² IV infusion over 2 hours, at the same time, in bags using a Y-line, followed by :
~5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by :
~5-FU 2400 mg/m² continuous IV infusion in 500 mL over 46-hours.
~*400 mg/m² of leucovorin expressed in dl racemic. When the l-isomer form is used the dose should be divided by 2, i.e. 200 mg/m²"
16399953|NCT02015819|Biological|E. coli CD-expressing genetically modified neural stem cells|Given intracranially
16399954|NCT02015819|Drug|flucytosine|Given orally
16399955|NCT02015819|Drug|leucovorin calcium|Given orally
16399956|NCT02015819|Other|pharmacological study|Correlative studies
16399957|NCT02015819|Other|laboratory biomarker analysis|Correlative studies
16399958|NCT02008357|Drug|Placebo|Administered IV
16399959|NCT02008357|Drug|Solanezumab|Administered IV
16399960|NCT02004691|Drug|placebo (saline)|"Pharmaceutical form: solution administered once every two weeks during the 52 weeks of the primary analysis period for patients randomized to placebo.
~Route of administration: intravenous infusion"
16399961|NCT02004691|Drug|GZ402665|"Pharmaceutical form: Powder for concentrate for solution for infusion administered once every two weeks during the 52 weeks of the primary analysis period for patients randomized to olipudase alfa, and during the extension treatment period for all patients.
~Route of administration: intravenous infusion"
16399962|NCT02002130|Drug|Placebo GABA and Placebo GAD-alum|Maltodextrin as a placebo formulation for GABA Placebo GAD-alum injection
16399963|NCT02002130|Drug|GABA and Placebo GAD-alum|Oral Active GABA with Placebo GAD-alum
16399964|NCT02002130|Drug|Active Oral GABA and Active GAD-alum injection|Active Oral GABA and Active GAD-alum injection
16399965|NCT01936831|Drug|Isoniazid|INH is available in 100 mg tablets. INH will be administered orally daily in the morning on an empty stomach. Doses of INH will be given according to the weight bands.
16399966|NCT01936831|Dietary Supplement|Vitamin B6|Vitamin B6 will be administered at >\= 25 mg daily and will be obtained locally for use by study participants.
16399967|NCT01896921|Drug|Switch to Maraviroc + Raltegravir or Dolutegravir|Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks
16399968|NCT01880827|Procedure|Roux-en-Y|Subjects in the intervention group will be divided into two consecutive surgical groups, RYGB or SG. After the surgery, subjects are controlled in hospital ward for approximately three days.
16399969|NCT01880827|Drug|GIP-infusion|Blood flow and volume during infusion
16399970|NCT01880827|Drug|GLP-1|Blood flow and volume during infusion
16399971|NCT01880827|Drug|MMS|Blood flow and volume after meal solution
16399972|NCT01880827|Procedure|Sleeve gastrectomy|as in RYGS group
16399973|NCT01841450|Device|iStent|Implantation of one iStent in conjunction with cataract surgery
16399974|NCT01841450|Procedure|Cataract surgery|Cataract surgery alone
16399975|NCT01838187|Radiation|I-131 MIBG|The therapeutic dose (5-18 mCi/kg at investigator's discretion; any dose ≥12 mCi/kg requires stored stem cells) will be diluted in normal saline, and will be infused intravenously over 90-120 minutes.
16399976|NCT01838187|Drug|Vorinostat|180 mg/m2 orally once daily on days 0 to +13
16399984|NCT01809132|Drug|Anakinra|Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.
16399985|NCT01809132|Drug|Pentoxifylline|Pentoxifylline, generic
16399986|NCT01809132|Drug|Zinc Sulfate|Zinc Sulfate, nutritional supplement
16399987|NCT01809132|Drug|Methylprednisolone|Methylprednisolone, corticosteroid
16399988|NCT01807611|Radiation|Total Lymphoid Irradiation|Participants receive total lymphoid irradiation over four doses.
16399989|NCT01807611|Drug|Fludarabine|Given IV.
16399990|NCT01807611|Drug|Cyclophosphamide|Given IV.
16399991|NCT01807611|Drug|Thiotepa|Given IV.
16399992|NCT01807611|Drug|Melphalan|Given IV.
16399993|NCT01807611|Biological|HPC,A Infusion|Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted).
16399994|NCT01807611|Biological|TC-NK Infusion|Participants receive infusions of TC-NK.
16399995|NCT01807611|Biological|G-CSF|"Participants receive G-CSF subcutaneously or intravenously.
~Donors receive G-CSF subcutaneously during cell mobilization."
16399996|NCT01807611|Drug|Mesna|Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide.
16399997|NCT01807611|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16399998|NCT01807611|Drug|Mycophenolate mofetil|Given intravenously or orally.
16399999|NCT01736592|Drug|Long term follow up in all patients who received SAR422459 in previous study TDU13583|Blood draw for the laboratory assessment
16400000|NCT01720173|Biological|Dalantercept|Given SC
16400004|NCT01590277|Drug|Ethanol|"Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.
~Potential Randomizations:
~placebo ethanol + and placebo iomazenil
~active ethanol + placebo iomazenil
~active ethanol + active iomazenil
~placebo ethanol + active iomazenil"
16400005|NCT01590277|Drug|Iomazenil|"Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.
~Potential Randomizations:
~placebo ethanol + and placebo iomazenil
~active ethanol + placebo iomazenil
~active ethanol + active iomazenil
~placebo ethanol + active iomazenil"
16400006|NCT01568723|Genetic|response to therapy|evaluate specific markers for response to therapy at specific intervals pre and post therapy
16400007|NCT01555788|Device|Artificial Pancreas for DiaPort system with Zone-MPC algorithm|Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
16400008|NCT01535053|Biological|Dactinomycin|Given IV
16400009|NCT01535053|Drug|Leucovorin Calcium|Given PO
16400010|NCT01535053|Drug|Methotrexate|Given IV and IM
16400011|NCT01535053|Other|Quality-of-Life Assessment|Ancillary studies
16400012|NCT01512654|Device|Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)|Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.
16400013|NCT01512654|Device|Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)|Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.
16400014|NCT01466270|Drug|donepezil hydrochloride|Given PO
16400015|NCT01466270|Drug|Placebo|Given PO
16400016|NCT01435018|Drug|Etoposide (ET)|"Beginning on day one of the chemotherapy cycle, ET was given orally in a dose of 50 mg twice daily for 7 consecutive days for the first cycle. If there was no Grade >= 2 toxicity attributable to ET after the first cycle, the dose was escalated to 150 mg daily for 7 days in divided doses of 100 mg/50 mg for the second cycle. After the second cycle, if there was no Grade >= 2 toxicity attributable to ET, the dose was escalated to 100 mg twice daily for 7 days for the third and subsequent cycles.
~Treatment with ET was continued for six cycles at the maximum dose achieved or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the protocol CMC, had determined that alternative therapy is required, whichever occurs first."
16400017|NCT01435018|Drug|Bleomycin and Vincristine (BV)|"BV was administered on day one of each chemotherapy cycle.
~Vincristine sulfate was administered at a dose of 2 mg (fixed dose) in a volume of 2 mL over 1 minute into the sidearm of a rapidly flowing intravenous infusion every 3 weeks. The vincristine infusion was followed by bleomycin as detailed below.
~Bleomycin sulfate was administered at a dose of 15 units/m^2 over 10 minutes every 3 weeks.
~Treatment with BV was continued for six cycles, or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the protocol CMC, had determined that alternative therapy is required, whichever occurs first."
16400018|NCT01435018|Drug|Paclitaxel (PTX)|Paclitaxel was administered by IV infusion in 200 mL, 250 mL, or 500 mL of 5% dextrose or 0.9%Sodium Chloride for injection at a dose of 100 mg/m^2 body surface area (BSA) every 3 weeks.
16400019|NCT01435018|Drug|Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)|"The following ART regimens were used:
~EFV/FTC/TDF (Atripla) 200 mg/300 mg/600 mg orally once daily at bedtime or
~FTC/TDF 200 mg/300 mg (Truvada) orally once daily at bedtime plus EFV (Stocrin) 600 mg orally once daily at bedtime or
~FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus nevirapine (NVP) 200 mg orally twice daily or
~FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus PI/r at standard dosing or
~FTC/TDF 200 mg/300 mg (Truvada) orally once daily plus integrase inhibitor at standard dosing"
16400020|NCT01432080|Drug|Prednisone|Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper.
16400021|NCT01432080|Drug|Azithromycin|Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months
16400022|NCT01432080|Drug|Montelukast|Montelukast 10 mg PO qhs for 3 months
16400023|NCT01432080|Drug|Symbicort|Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months
16400024|NCT01415882|Drug|Cyclophosphamide|Given PO
16400025|NCT01415882|Biological|Daratumumab|Given IV
16400026|NCT01415882|Drug|Dexamethasone|Given PO or IV
16400027|NCT01415882|Drug|Ixazomib Citrate|Given PO
16400028|NCT01415882|Other|Laboratory Biomarker Analysis|Correlative studies
16400029|NCT01343550|Other|creativity group|This is a creativity group intervention. There will be 4 groups. Each group has one session per week. Each session is a duration of two hours.
16400030|NCT01332968|Drug|Obinutuzumab|Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.
16400031|NCT01332968|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
16400032|NCT01332968|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
16400033|NCT01332968|Drug|Vincristine|Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
16400034|NCT01332968|Drug|Prednisone|Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
16400035|NCT01332968|Drug|Bendamustine|Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
16400036|NCT01332968|Drug|Rituximab|Rituximab 375 milligrams per square meter (mg/m^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m^2 every 2 months during maintenance period.
16400037|NCT01239797|Drug|Lenalidomide|Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
16400038|NCT01239797|Drug|Dexamethasone|Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
16400039|NCT01239797|Drug|Dexamethasone (Oral)|"On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.
~On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
16400040|NCT01239797|Drug|Dexamethasone (IV)|"On weeks without Elotuzumab dosing: Not Applicable (N/A)
~On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug"
16400041|NCT01239797|Biological|Elotuzumab (BMS-901608; HuLuc63)|Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16400042|NCT01111539|Drug|Escitalopram|Escitalopram capsule administered orally, once daily without regard to meals.
16400043|NCT01111539|Drug|Aripiprazole|Aripiprazole capsule administered orally, once daily without regard to meals.
16400044|NCT01111539|Drug|Blinded capsule|Blinded capsule administered orally, once daily.
16400045|NCT01032603|Procedure|Bilateral lateral rectus recession (BLRc)|Bilateral lateral rectus recession surgery
16400046|NCT01032603|Procedure|Unilateral lateral rectus recession with medial rectus resection (R&R)|A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
16400047|NCT01028846|Drug|Diazoxide|1-2 mg/kg total dose given intravenously
16400048|NCT01028846|Drug|Placebo|Intravenous normal saline
16400049|NCT01001910|Drug|Carboplatin|Given IV
16400050|NCT01001910|Other|Laboratory Biomarker Analysis|Correlative studies
16400051|NCT01001910|Drug|Pemetrexed Disodium|Given IV
16400052|NCT00994279|Behavioral|Yoga|Yoga sessions
16400053|NCT00994279|Behavioral|Education|Educational Wellness Group
16400054|NCT00989651|Biological|Bevacizumab|Given IV
16400055|NCT00989651|Drug|Carboplatin|Given IV
16400056|NCT00989651|Drug|Cisplatin|Given IP
16400057|NCT00989651|Other|Laboratory Biomarker Analysis|Correlative studies
16400058|NCT00989651|Drug|Paclitaxel|Given IV or IP
16400059|NCT00989651|Drug|Veliparib|Given PO
16400060|NCT00959842|Drug|Lovaza|1 gram gel capsule 4 capsules per day for 8 weeks
16400061|NCT00916955|Other|Observation|Observe development of syndrome over time
16400062|NCT00888615|Drug|Elesclomol Sodium|Given IV
16400063|NCT00888615|Drug|Paclitaxel|Given IV
16400064|NCT00727103|Drug|Varenicline|Varenicline will be dispensed in 0.5 mg and 1 mg tablets taken orally. During the first 3 days of medication, participants will take one 0.5 mg tablet of varenicline daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 mg (1 tablet) po twice daily. At the end of the 8th week, varenicline will be discontinued.
16400065|NCT00727103|Drug|Placebo|Placebo will be dispensed in color-coded capsules. Blue capsules will contain 0.5 mg glucose (placebo), red capsules will contain 1 mg glucose (placebo).
16400066|NCT00706394|Device|Endologix Powerlink 34 mm stent graft cuff|Endovascular abdominal aortic aneurysm repair
16400067|NCT00695786|Drug|Lenalidomide|Given PO
16400068|NCT00695786|Biological|Rituximab|Given IV
16400069|NCT00694655|Biological|Yellow fever vaccine|YFV will be given as injection
16400070|NCT00674817|Drug|400 microgrammes GSK961081|Inhaled GSK961081 administered via Dry Powder Inhaler.
16400071|NCT00674817|Drug|1200 microgrammes GSK961081|Inhaled GSK961081 adminisntered via dry powder inhaler.
16400072|NCT00633958|Drug|18F-FLT|Patients will receive a dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Dosing will be based on age.
16400073|NCT00633958|Radiation|PET Imaging|
16400074|NCT00369785|Drug|donepezil hydrochloride|Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
16400075|NCT00369785|Drug|Placebo|Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
16400076|NCT00326625|Drug|40 mg glatiramer acetate|parenteral drug
16400077|NCT00326625|Drug|Placebo|
16400078|NCT05088421|Drug|BWC0977|"SAD Cohorts: Double-blind dosing will occur. Six participants will receive single doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
~MAD Cohorts: Double blind dosing will occur. Six participants in each cohort will receive multiple doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Dosing frequency to be confirmed based on safety, tolerability and PK data from SAD cohorts. Daily dosing will continue for a total of 10 consecutive days."
16400079|NCT05088421|Drug|Placebo|SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
16400080|NCT05088408|Dietary Supplement|Resource® Energy Apricot|"Bowel preparation as usual plus two bottles of Resource® Energy Apricot (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), with ingestion of one bottle of 200 mL of the dietary supplement at 08:00 and the other at 12:00, and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning).
~Colonoscopy."
16400113|NCT05088174|Drug|Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule|"Drug:
~Hetrombopag Olamine Tablet Ciclosporin Soft Capsule"
16400114|NCT05088148|Other|. Pesticide and Pharmaceutical analysis|Pesticide and Pharmaceutical analysis will be done with LC-MS/MS device.
16400262|NCT05087030|Drug|Prolia®|Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.
16400081|NCT05088408|Other|Bowel preparation as usual.|"Bowel preparation as usual (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning).
~Colonoscopy."
16400085|NCT05088369|Drug|HM201|HM201 will be administered intravenously.
16400086|NCT05088369|Drug|Placebo|Placebo will be administered intravenously.
16400087|NCT05088369|Drug|HM201|HM201 will be administered intravenously.
16400088|NCT05088369|Drug|Placebo|Placebo will be administered intravenously.
16400097|NCT05088343|Drug|Rosuvastatin|Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.
16400098|NCT05088343|Drug|Hetrombopag|7.5 mg hetrombopag was administered on Day 6 to Day 11.
16400099|NCT05088330|Drug|Daratumumab|treatment with D-VRD in NDMM
16400100|NCT05088317|Diagnostic Test|Exercise Capasity|The incremental shuttle walking test at increasing speed is one of the field tests used to evaluate exercise capacity. It has been shown that AHMYT is a valid and reliable assessment tool that can be used to evaluate exercise capacity in obese individuals. This test is an exercise test in which walking between two cones 10 m apart at increasing speed for 12 minutes is counted as one sit-up for each 10-meter walk between the two cones. It is continued until the patient is unable to continue the test due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or completes the 12-minute test. In this test, the primary measure is the distance walked, and the result is calculated based on the number of shuttles completed.
16400101|NCT05088304|Other|no intervention|
16400102|NCT05088278|Procedure|Anatomical single bundle ACL reconstruction with hamstrings|Anatomical ACL reconstruction with quadruple-bundle hamstrings graft
16400103|NCT05088278|Procedure|Anatomical single bundle ACL reconstruction with patellar tendon|Anatomical single bundle ACL reconstruction with patellar tendon
16400104|NCT05088278|Procedure|ACL reconstruction with over the top plus lateral plasty technique|Non-anatomical ACL reconstruction, the hamstrings' tibial insertion is preserved; a double-bundle hamstring graft is passed intra-articularly, fixed in over the top position on the lateral femoral condyle, and then passed extra-articularly deeply to ileo-tibial band up to the tibia, where it is fixed at the level of Gerdy's tubercle.
16400105|NCT05088265|Device|Bigfoot Unity Diabetes Management System|The Bigfoot Unity System is a wirelessly connected set of hardware and software that is intended for use by people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. Bigfoot Unity consists of the Abbott FreeStyle Libre 2 Sensor, two durable insulin pen caps (one each for specific rapid-acting and long-acting insulin pens) and an iOS-specific mobile App.
16400106|NCT05088252|Drug|Desflurane|After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.
16400107|NCT05088252|Drug|Propofol|After induction, anesthesia will be maintained with 6-8mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil.
16400108|NCT05088239|Drug|prophylactic antibiotics duration|Prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative care. Different discontinued duration of antibiotics was divided to 3 groups in one day, 3 days and until to drain removal.
16400109|NCT05088226|Drug|Ruxolitinib combined with Chidamide.|"Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide .
~Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI , Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;"
16400110|NCT05088213|Procedure|suction mini percutaneous nephrolithotomy|18Fr suction sheath (Weili, China) was inserted, and 12Fr mini-nephroscope was used, kidney stones was fragmented by pneumatic lithotriptor (LithoClast Master, Switzerland) or Ho:YAG laser（0.8-1.0W*20-30Hz）, and stone fragments was sucked out with the suction sheath.
16400111|NCT05088213|Procedure|standard percutaneous nephrolithotomy|24-30Fr sheath was inserted, and 20Fr nephroscope (Richard Wolf, Germany) was used, kidney stones was disintegrated and sucked out by ultrasonic-lithotripter (LithoClast Master, EMS, Switzerland or ShockPluse-SE, Olympus).
16400112|NCT05088200|Procedure|surgery|Our study is observational and we use secondary data
16400546|NCT04964934|Drug|Letrozole|Dosage formulation: letrozole tablets will be administered orally.
16400115|NCT05088135|Device|Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.|It will be divided three groups as bilateral Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.
16400116|NCT05088135|Device|Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.|It will be divided three groups as unilateral-right Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.
16400117|NCT05088135|Device|Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.|It will be divided three groups as unilateral-left Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.
16400118|NCT05088122|Other|no intervention|no intervention, not applicable
16400120|NCT05088083|Device|Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon|After predilation, using drug-coated balloon catheter to cover the whole treated segment
16400121|NCT05088070|Drug|SPH 3348|2 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach
16400122|NCT05088070|Drug|SPH 3348|1 tablet of 40mg SPH3348 will be orally administered once a day with empty stomach
16400123|NCT05088070|Drug|SPH 3348|2 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
16400124|NCT05088070|Drug|SPH 3348|4 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
16400125|NCT05088070|Drug|SPH 3348|6 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
16400126|NCT05088070|Drug|SPH 3348|8 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
16400127|NCT05088057|Drug|Camrelizumab|200mg on Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles (Q3W), intravenous (IV) infusion.
16400128|NCT05088057|Drug|Doxorubicin|60mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
16400129|NCT05088057|Drug|Cyclophosphamide|600 mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
16400130|NCT05088057|Drug|Docetaxel|75mg/m² on Day 1 of Cycles 1-4 (Q3W) or Cycles 5-8 (Q3W) of the neoadjuvant phase of the study, IV infusion;
16400131|NCT05088044|Other|training porogram|training on modified early warning signs will be given to staff nurses and they will be asked to mark physiological parameters on MEWS chart and identify detrioration
16400132|NCT05088031|Device|shock waves therapy|"Group (A): 20 patients would undergo shock waves plus traditional physical therapy. One thousand shock waves (7 times per sec) were applied at 2.5 Hz at low energy flux densities of 0.01-0.16 mJ/mm2 using a 17 mm head 2-Group (B): 20 patients would undergo intermittent mechanical traction plus conventional physical therapy. Participants would undergo 30 minutes of mechanical traction (with 10-second pull and 5-second rest)"
16400133|NCT05088018|Other|Cannabigerol|Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.
16400134|NCT05088018|Other|Placebo|A placebo form of the same swallowable tablet with no cannabigerol
16400135|NCT05088005|Procedure|Hyperbaric oxygen therapy|Patients with any symptoms and signs were treated with HBO2. During the first HBO2, initial compression was performed to 2.8 atmospheres absolute (ATA) for 45 min, followed by 2.0 ATA for 60 min. If an additional HBO2 was possible within 24 h, then 2.0 ATA was administered for 90 min.
16400140|NCT05087953|Diagnostic Test|Head-Up Tilt table test|Autonomic response assessment in the orthostatic head up tilt test.
16400141|NCT05087953|Diagnostic Test|Heart Rate Variability|Assessment of heart rate variability on 24-hour Holter monitoring..
16400143|NCT05087927|Behavioral|Gain framing plus demographically targeted photos|"Gain framing: Participant feels PrEP puts her in control
~Participants (majority of whom will be African American) will be shown an image of women of multiple races."
16400144|NCT05087927|Behavioral|Loss framing plus demographically targeted photos|"Loss framing: Without PrEP, participant feels less in control
~Participants (majority of whom will be African American) will be shown an image of women of multiple races."
16400145|NCT05087927|Behavioral|Gain framing plus not demographically targeted photos|"Gain framing: Participant feels PrEP puts her in control
~Participants (majority of whom will be African American) will be shown an image of an African American woman."
16400186|NCT05087680|Behavioral|Enhanced Standard of Care|Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.
16400146|NCT05087927|Behavioral|Loss framing plus not demographically targeted photos|"Loss framing: Without PrEP, participant feels less in control
~Participants (majority of whom will be African American) will be shown an image of an African American woman."
16400147|NCT05087914|Drug|Carbidopa-Levodopa (100mg/25mg):|Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.
16400148|NCT05087914|Drug|Naproxen|Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.
16400149|NCT05087901|Diagnostic Test|Multifocal electroretinogram|A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion
16400150|NCT05087888|Procedure|Biospecimen Collection|Undergo collection of blood samples
16400151|NCT05087888|Procedure|Magnetic Resonance Imaging|Undergo functional MRI
16400152|NCT05087888|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo multiparametric MRI
16400153|NCT05087888|Other|Questionnaire Administration|Complete questionnaires
16400156|NCT05087862|Procedure|Ultrasound-guided pericapsular nerves group of the hip block|After the ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% bupivacaine.
16400157|NCT05087862|Procedure|Pericapsular local anesthetic infiltration of the hip|Intraoperatively, 60 mL of adrenalized 0.25% bupivacaine plus ketorolac 30 mg will be infiltrated by the surgeon.
16400158|NCT05087849|Biological|nonavalent human papillomavirus vaccine|Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
16400159|NCT05087836|Device|Sensor at forehead area|NIRS sensor attached at forehead area.
16400160|NCT05087836|Device|Sensor at temporal area|NIRS sensor attached at temporal area.
16400161|NCT05087823|Dietary Supplement|Lipid Challenge|For the lipid challenge, participants consume 100 grams of a long chain triglyceride emulsion in the form of liquid drink, which is the commercially available brand called Calogen, from Nutricia, Inc.
16400162|NCT05087823|Dietary Supplement|Glucose Challenge|For the glucose challenge, participants consume 75 grams of glucose in 200 milliliters of water, which is the World Health Organization (WHO) recommended drink for the Oral Glucose Tolerance Test.
16400163|NCT05087823|Dietary Supplement|Mixed Meal Challenge|For the mixed-meal challenge, participants consume 237 milliliters of the Ensure Enlive nutrition drink , which contains 11 grams of fat, 22 grams of sugar and 20 grams of protein.
16400164|NCT05087810|Behavioral|Psychological stress induction|Subjects will undergo acute psychological stress induction by performing mental arithmetic tasks.
16400165|NCT05087810|Other|Accelerated oral hydration|Participants will drink 2L of fluid in a short period of time to force diuresis and urine production.
16400166|NCT05087797|Drug|nicorandil|Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months
16400167|NCT05087784|Combination Product|Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps|Patient-centered, technology-supported integrated survivorship- and care management
16400168|NCT05087771|Drug|injectable naltrexone|360 mg dose to be given prior to hospital discharge
16400169|NCT05087771|Drug|oral naltrexone|50 mg tab dispense 30 day supply to be given at hospital discharge
16400170|NCT05087758|Other|Matrion|Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
16400171|NCT05087758|Other|Conventional Care Wound Management|Advanced wound care with debridement and dressings
16400172|NCT05087745|Biological|Tumor Infiltrating Lymphocytes|Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.
16400173|NCT05087732|Device|STYLAGE® M Lidocaïne|Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).
16400174|NCT05087732|Device|STYLAGE® M|Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).
16400175|NCT05087719|Combination Product|experimental group|patients will receive the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints,stereognosis will be of 15 minutes. For motor training patients will practice 15 mints motor tasks
16400176|NCT05087719|Combination Product|conventional treatment|patients will receive the baseline treatment of hot pack for 15 minutes. The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist.
16400177|NCT05087706|Drug|Pyrotinib|Pyrotinib 400mg qd po
16400178|NCT05087706|Drug|Bicalutamide|Bicalutamide was administered orally at a daily dose of 50 mg
16400179|NCT05087706|Drug|Leuprorelin|Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks
16400180|NCT05087693|Drug|Salbutamol|Inhaling 200ug of salbutamol
16400181|NCT05087693|Drug|Placebo medication|Inhaling placebo medication
16400182|NCT05087693|Other|Ozone|Breathing 170ppb ozone
16400183|NCT05087693|Other|Filtered Air|Breathing filtered air
16400184|NCT05087693|Other|Exercise|Cycling at 60% of VO2max on a cycle ergometer
16400185|NCT05087680|Behavioral|ACTPrEP|ACTPrEP will include a 60-minute initial session and a series of 30-minute follow-up sessions. Sessions will focus on the Thoughts, Emotions, Associations, Memories, and Sensations (TEAMS) relevant to PrEP uptake and adherence.
16400187|NCT05087667|Device|Implantation of Sterile Self Locking Polymer Cerclage System|implantation of Sterile Self Locking Polymer Cerclage System to the patient and follow up for 36 months post-intervention
16400188|NCT05087667|Device|Implantation of Cerclage used in current practice|implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention
16400189|NCT05087654|Other|Combination of 3D VR and Hands-on Horticultural Activities|The intervention program consisted of 8 two-hour sessions that were conducted once a week for 8 consecutive weeks.
16400190|NCT05087641|Device|IAB System|Bronchoscopic implantation of one or multiple IABs
16400191|NCT05087628|Biological|PRV-3279|Bi-specific antibody-based molecule
16400192|NCT05087628|Other|Placebo|Placebo
16400197|NCT05087602|Drug|Toripalimab and Anlotinib|Toripalimab 240 mg IV on Day 1 of each 14-day cycle plus Anlotinib capsules given 10mg orally in fasting conditions , once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
16400198|NCT05087589|Drug|Tofacitinib|Tofacitinib 5mg was taken orally twice a day for 6 months
16400201|NCT05087563|Device|Neurolens spectacle lens|spectacle lens
16400202|NCT05087563|Device|Placebo spectacle lens|spectacle lens for refractive correction
16400203|NCT05087550|Procedure|Liver Transplantation|Patients who underwent liver transplantation at Methodist Dallas Medical Center
16400207|NCT05087511|Other|motor and sensory development assessment|Peabody Motor Development Scale 2 was used to evaluate motor development and Dunn's Sensory Profile was used to evaluate sensory processing.
16400208|NCT05087498|Biological|autologous cord blood mononuclear cells|preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) within 24 hours after birth
16400209|NCT05087498|Biological|normal saline|preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth
16400210|NCT05087485|Other|education|digital education in skin cancer diagnostics
16400211|NCT05087459|Drug|Avatrombopag|On the basis of conventional treatment, Avatrombopag was added, 30×10^9/L < platelet count < 50×10^9/L patients received Avatrombopag 60mg/d, 50×10^9/L≤ platelet count < 75×10^9/L patients received Avatrombopag 40mg/d for 5 consecutive days, and waited for a period of time after drug withdrawal.Surgery is expected to take place on day 10-13 of the initial dose.
16400214|NCT05087433|Other|Progressive Relaxation Exercises|The trainer performed the PRE exercise online with the nurses. The video recording of the progressive relaxation exercises was shared with the nurses participating in the study on WhatsApp groups. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. The PRE application was reminded daily from the WhatsApp group for the nurses to apply regularly to the sessions and not to disrupt the sessions. Nurses shared the messages stating that they were doing the PRE application on a daily basis for four weeks on WhatsApp groups.
16400217|NCT05087394|Other|Comorbidities|Risk factors (comorbidities), requirements of respiratory suppot and chest imaging will are considered exposure for primary outcomes
16400218|NCT05087381|Drug|FluvoxaMINE Maleate 50 MG|"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime.
~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."
16400219|NCT05087381|Combination Product|Fluvoxamine, Bromhexine|"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.
~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."
16400220|NCT05087381|Combination Product|Fluvoxamine, Cyproheptadine|"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with cyproheptadine 4 mg, 1 tablet, three times, orally after meals and should be taken every 8 hours apart, for 14 days.
~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."
16400221|NCT05087381|Drug|Niclosamide Pill|"The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days.
~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."
16400222|NCT05087381|Combination Product|Niclosamide, Bromhexine|"The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days. Co-administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.
~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."
16400223|NCT05087368|Biological|ChAdOx1-S COVID-19 Vaccine(Fiocruz/Oxford-AstraZeneca)|Heterologous and Homologous Vaccination Series with ChAdOx1-S or CoronaVac COVID-19 Vaccines and Various Formulations of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Adults
16400224|NCT05087368|Biological|CoronaVac (Sinovac Biotech)|Heterologous and Homologous Vaccination Series with ChAdOx1-S or CoronaVac COVID-19 Vaccines and Various Formulations of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Adults
16400225|NCT05087368|Biological|Adjuvanted Recombinant SARS-CoV-2 TrimericS-protein Subunit Vaccine (SCB-2019 - Clover)|Heterologous and Homologous Vaccination Series with ChAdOx1-S or CoronaVac COVID-19 Vaccines and Various Formulations of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Adults
16400227|NCT05087342|Drug|Semaglutide 2.4mg|The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.
16400228|NCT05087342|Drug|Placebo|A placebo will be given to the control group per the schedule outlined in the armed description.
16400229|NCT05087329|Behavioral|Virtual Mindfulness Meditation|Four week virtual mindfulness meditation course composed of four weekly group Zoom webinars during which participants will listen to a 15-20 minute pre-recorded meditation, facilitated by a study provider
16400230|NCT05087316|Device|biomimetic oral appliance therapy (BOAT)|BOAT appliance is designed to correct maxillo-mandibular underdevelopment in both children and adults (Singh and Lipka, 2009). However, adults will only use for this study. Typically, a BOAT appliance consists of 6 patented, anterior 3-D Axial Springs™, a midline actuator (such as omega loops or screws), posterior occlusal rests, and a round labial bow (Figure 1). Patients will be trained on activation of the screw
16400231|NCT05087316|Device|Standard hospital treatment|Use of CPAP and similar methods
16400232|NCT05087303|Other|Types of Telemedicine Delivery Models|Each arm delivers standard sickle cell care using a different model based on patient location.
16400624|NCT04902144|Behavioral|Behavioral Intervention|Receive coaching
16400235|NCT05087264|Drug|Indocyanine green|ICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium.
16400236|NCT05087251|Behavioral|Five Psycho-educational Session(s)|5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
16400237|NCT05087251|Behavioral|One Psycho-educational Session(s)|1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations
16400238|NCT05087238|Behavioral|CBT|Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention
16400239|NCT05087225|Biological|polyethelyene glycol|the excipients at covid-19 vaccines
16400240|NCT05087212|Drug|plerixafor + G-CSF|subcutaneous (SC) injection
16400241|NCT05087199|Diagnostic Test|Rt-PCR.|Nasopharyngeal swab for Rt-PCR for COVID-19
16400242|NCT05087186|Behavioral|Guided imagery and FLASH technique|"Five virtual group sessions delivered by psychological therapists;
~Sessions 1 and 2: Guided imagery
~Sessions 3 and 4: FLASH technique
~Session 5: Refresher on guided imagery and FLASH technique"
16400243|NCT05087173|Device|Chatbot|An interactive chatbot for patient decision aid A chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of COVID-19 vaccination.
16400244|NCT05087160|Other|mitigation measures against COVID 19|no intervention
16400245|NCT05087147|Device|0.7 mm stainless steel orthodontic wire|0.7 mm stainless steel orthodontic wire
16400246|NCT05087147|Device|Banded space maintainer|band and loop space maintainer
16400247|NCT05087134|Drug|11C-Choline|11C-Choline were injected into the patients before the PET/CT scans
16400248|NCT05087121|Behavioral|Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F)|The Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) 6-week training course has been derived from existing Cognitive Behavioral Therapy for Insomnia (CBT-I) group therapy protocols. Participants in this intervention will receive psychoeducation on sleep and practice skills standard of CBT-I including, stimulus control techniques, sleep restriction, counter-arousal skills, cognitive restructuring, sleep hygiene, goal setting, and relapse prevention skills. Weekly sessions will include discussions regarding difficulties specific to occupational barriers and how to mitigate the impact of occupational requirements on sleep quality.
16400249|NCT05087121|Device|Fitbit Inspire HR Wrist Worn Device (NCT04176926)|"The Fitbit Inspire HR wrist worn device will be worn by eligible participants throughout the duration of the intervention and for two weeks following completion of the 6-week intervention to collect objective data on enduring sleep changes. This device is an FDA-registered medical device that is not the object of investigation and is being used on label only to gather data.
~501(K) Number: K200948 Device Name: Fitbit ECG App Regulation Number: 870.2345 Classification Product Code: QDA Clinical Trials: NCT04176926"
16400250|NCT05087108|Device|OsciPulse system|The OsciPulse system is an intermittent pneumatic limb compression system. The OsciPulse sleeves that are applied to the top portion of the user's calves and are periodically inflated with rapid bursts of compressed air to create frequent pulses of venous return.
16400251|NCT05087108|Device|Reference Therapy 1|The Venaflow Elite is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Venaflow system sleeves cover the entire calf region of the user and contain two bladders that are inflated sequentially to induce venous return.
16400252|NCT05087108|Device|Refence Therapy 2|The Kendall SCD device is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Kendall SCD sleeves cover the entire calf region of the user and contain three bladders that are inflated sequentially to induce venous return.
16400253|NCT05087095|Behavioral|CALM Intervention|"The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:
~Within one week before initiating the CALM intervention therapy
~Within one week after its completion,
~3 months after the CALM intervention is complete
~After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components"
16400254|NCT05087095|Behavioral|Survey Administration|"Participants will be asked to complete self-report surveys of behavioral and psychological variables at the following timepoints:
~Within one week before initiating the treatment as usual
~Within one week after its completion,
~3 months after the treatment as usual is complete"
16400255|NCT05087082|Other|Virtual Hospital at Home - Home admission of epidemic patients|Admitting COVID-19 patients at home
16400256|NCT05087069|Drug|BV100|Rifabutin for Infusion
16400257|NCT05087069|Drug|Placebo|Saline intravenous infusion
16400258|NCT05087056|Combination Product|MenABCWY vaccine|Two doses of the MenABCWY vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, on a 0-, 24-month schedule in the ABCWY-24 Group, and a 0-, 48-month schedule in the ABCWY-48 Group.
16400259|NCT05087056|Combination Product|Placebo|Single dose of Placebo (saline solution in pre-filled syringe), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1441 in the ABCWY-24 Group, and at Day 721 in the ABCWY-48 Group.
16400260|NCT05087043|Device|Oral motor stimulation (OMS) and The supplemental nursing system (SNS)|OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.
16400263|NCT05087017|Other|Intervention group|Patients with medical condition to follow the rehabilitation program will be asked to answer questionnaires to assess their sleep quality.
16400264|NCT05087004|Behavioral|Teen Council|Youth randomly selected for Teen Council attended weekly meetings for an entire school year to receive training on specific topics. In turn, they provided educational presentations to the community, which required that they miss school (about one day per month). The presentations Teen Council members offered in middle and high schools were most commonly on birth control methods; relationships; reproductive anatomy and physiology; sexual diversity; STDs/STIs; sexual consent; HIV/AIDS; and abstinence.
16400265|NCT05086991|Other|Follow up|like group descriptions
16400266|NCT05086965|Other|Playing the virtual game simulation|The virtual game simulation developed by the researchers and designed by the researchers will be played on the computer for the students of the intervention group. Virtual game simulations are virtual games developed by researchers, specific to a clinical scenario, and prepared by transferring the videos taken with an action camera to the computer environment and displaying them in two dimensions.
16400267|NCT05086952|Drug|Vericiguat (BAY1021189) - Intervention A|Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fed state.
16400268|NCT05086952|Drug|Vericiguat (BAY1021189) - Intervention B|Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fasted state.
16400269|NCT05086952|Drug|Vericiguat (BAY1021189) - Intervention C|Single dose of 2.5 mg vericiguat low-concentration pediatric formulation (oral liquid formulation) in fed state.
16400270|NCT05086952|Drug|Vericiguat (Verquvo, BAY1021189) - Intervention D|Single dose of 10 mg vericiguat immediate release (IR) intact tablet in fed state.
16400274|NCT05086926|Combination Product|Exercises and CSI|"Corticosteroid injection:
~The project manager will give the participants one injection with cortisone and lidocaine in the lateral hip at baseline. The procedure will be performed aseptically.
~Home exercise program:
~The exercise programis based on previous literature and expert opinions that has been synthesized in a Delphi study conducted by our research group. The exercise program consists of three body weighted strength exercises, that are to be performed every second day for a period of 8 weeks. Exercise instructions will be available as a handout and online with video instructions. The corticosteroid injection usually causes a flare-up in pain with a duration of up to 48 hours. Participants will be instructed to begin the exercises as soon as possible after this flare-up has settled."
16400275|NCT05086913|Other|Lifestyle medicine smartphone booklets|Participants will receive a pocket size 6-page booklet weekly over 8 weeks that covers 8 lifestyle medicine, mental health and CBT themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology, and guides participants to set and meet short term and long-term goals.
16400276|NCT05086913|Other|Lifestyle medicine smartphone app|The lifestyle medicine app offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges, record of goals, and ecological momentary assessments of diet, physical activity, sleep, stress and mood.
16400277|NCT05086913|Other|Waitlist control|The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
16400278|NCT05086900|Other|Non-interventional Cross-sectional Patient Reported Outcome Measure Development|Development of Patient Reported Outcome Measure
16400279|NCT05086887|Diagnostic Test|Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases|All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.
16400280|NCT05086874|Other|butylphthalide|Observational only and no predesigned interventions in this study
16400281|NCT05086861|Device|Oesophageal pacing after left atrial posterior wall isolation|Following AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall. entrance and exit block.
16400282|NCT05086848|Drug|Irinotecan liposome、5-fluorouracil、Leucovorin|Irinotecan liposome、5-fluorouracil、Leucovorin
16400283|NCT05086835|Other|Working Memory Task|A smartphone-based visual-spatial working memory task that will be optimized in the Stage 1A phase of this study.
16400284|NCT05086835|Other|Visual Search Task|A smartphone-based visual search task that will be optimized in the Stage 1A phase of this study.
16400285|NCT05086822|Drug|Irinotecan liposome|Irinotecan liposome
16400286|NCT05086809|Device|Device A|Participant wear Device A and evaluate the performance of the device.
16400287|NCT05086809|Device|Device B|Participant wear Device B and evaluate the performance of the device.
16400289|NCT05086783|Other|Video-based coaching|The coaching session will follow the Wisconsin Coaching Framework (Greenberg 2015). The surgical coaching session will last at maximum 30 minutes and will occur within 1-2 week following the procedure. The surgical coaching session will occur over Zoom. The second attempt will occur within 1 week following the coaching session.
16400290|NCT05086783|Other|Standard surgical teaching (master-apprentice model - (MAM))|Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).
16400293|NCT05086757|Behavioral|TRRP|Receive TRRP services
16400294|NCT05086757|Behavioral|Enhanced Usual Care|Participants will receive an educational flyer with service referrals
16400296|NCT05086731|Other|Best Practice|Receive standard of care
16400297|NCT05086731|Other|Informational Intervention|Receive reminders
16400298|NCT05086731|Other|Medical Device Usage and Evaluation|Receive a SMRxT smart pill bottle
16400299|NCT05086731|Other|Quality-of-Life Assessment|Ancillary studies
16400300|NCT05086731|Other|Survey Administration|Ancillary studies
16400301|NCT05086718|Other|Endoscopic ear surgery|Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.
16400302|NCT05086705|Device|EMBr Wave|Use EMBr Wave
16400303|NCT05086705|Other|Questionnaire Administration|Ancillary studies
16400306|NCT05086679|Device|Compression Stockings with 25-30 mm Hg pressure|The group will have compression stockings with 25-30 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS and how to keep them will be provided for the participants with their compression stockings.
16400307|NCT05086679|Device|Compression stockings with up to 10 mm Hg pressure|The group will have compression stockings with up to 10 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS and how to keep them will be provided for the participants with their compression stockings.
16400308|NCT05086679|Behavioral|Lifestyle modification|All patients will receive standard treatment of VVS despite their randomization(drink 2-3 liters of fluids, consume 10 grams 120 mmol/day of sodium chloride, and practice counter-pressure maneuvers (squatting, leg crossing, handgrip, and arm-tensing))
16400309|NCT05086666|Drug|AZD4547|"In Phase 1b study, subjects will receive continuous twice daily dosing in 21-day cycles (no matter if missed doses or delays exist), with pre-set dose cohorts of 80 mg BID and 120 mg BID.
~In Phase 2, subjects will receive continuous twice daily dosing in 21-day cycles with the RP2D or other doses as determined by the investigator and sponsor."
16400310|NCT05086653|Procedure|Surgery|Sutured by Prolene 3-0 with two layers of pledge
16400311|NCT05086640|Other|Lemon foot to prevent blister|The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.
16400312|NCT05086627|Drug|Tislelizumab|Patients were treated with Tislelizumab (days 11, 33, 55, 77)
16400313|NCT05086627|Radiation|Short-course radiotherapy|Patients were treated with short-course neoadjuvant radiotherapy
16400314|NCT05086627|Drug|Capecitabine+Oxaliplatin|Patients were treated with neoadjuvant chemoherapy with CapeOX
16400315|NCT05086614|Drug|Thymosin Alpha1|Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.
16400316|NCT05086601|Procedure|colorectal cancer surgery|Any surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery.
16400318|NCT05086536|Other|no intervention|This is a retrospective and observational study.
16400319|NCT05086523|Device|Programmable Hypertension Control (BackBeat Moderato)|Programmable Hypertension Control can be turned OFF without affecting regular pacing
16400320|NCT05086523|Device|Pacing (BackBeat Moderato)|Programmable Hypertension Control can be turned OFF without affecting regular pacing
16400322|NCT05086497|Diagnostic Test|Whole Brain Spectroscopy Imaging Array Mapping Layout|All study participants will receive whole brain spectroscopy imaging as a part of MRI study time points. Participants assigned to the advanced MR imaging array mapping layout study arm will receive tumor treating fields mapping from Optune that is created from the spectroscopy sequences or advanced MR imaging. Participants assigned to the conventional array mapping layout will still receive advanced imaging sequences or spectroscopy imaging at all time points.
16400323|NCT05086471|Device|NaviCam SB|Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time.
16400324|NCT05086471|Device|PillCam SB3|Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time.
16400325|NCT05086458|Dietary Supplement|probiotics|probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis
16400326|NCT05086445|Drug|LY3502970|Administered orally
16400327|NCT05086445|Drug|Placebo|Administered orally
16400328|NCT05082545|Drug|SHR-2002 and SHR-1316|Cohort study
16400329|NCT05081739|Diagnostic Test|Prospera Transplant Assessment|"Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of dd-cfDNA in the patient's blood, without the need for prior donor or recipient genotyping.
~Prospera is a commercially available LDT developed by Natera, Inc. Natera is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA)."
16400331|NCT05078593|Drug|HLX26|Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody
16400332|NCT05078437|Behavioral|Medication therapy management|The proposed deprescribing intervention is using a patient-centered framework by: (1) balancing the risks and benefits, and addressing the specific needs of each individual patient, (2) considering the individual patient and the caregiver's preferences and values, and (3) empowering the patient and the caregiver to take responsibility and fully participate in the decision-making process as equal team players.
16400333|NCT05078333|Other|dry needle|dry needling (on 3 trigger points on the bilateral trapezius muscle) will applied to the other 36 randomly selected patients with an acupuncture needle with a size of 0.25x0.25 by the PMR specialist for a total of 6 sessions twice a week for 3 weeks.
16400334|NCT05078333|Device|high intensity laser therapy|High intensity laser therapy (HILT), one of the physical therapy methods, was approved by the FDA in 2002. Its beneficial and versatile effect has been proven in the treatment of many musculoskeletal diseases. In addition to the exercise program, randomly selected 36 case patients + HILT (BTL brand 6000 series, United Kingdom), to the cervical area, for the a period of 3 week-weekdays, 15-minute period and 15 sessions (1.02 minutes for each 25 cm² painful area, analgesic phase, with an anergy 8.0 W, a dose 5 J / cm², a frequency of 25 Hz and total 125 joules) will be applied.
16400335|NCT05077852|Diagnostic Test|Urethrocystoscopy|Patients diagnosed with a primary bladder cancer at the base, trigone or neck of the bladder with USG in the urology clinic will be evaluated with urethrocystoscopy. With urethrocystoscopy, patients definitive diagnosed with bladder cancer and IPP.
16400336|NCT05077514|Behavioral|Experimental: Cognitive Behavior Therapy|Participants assigned to Group A were asked to participate in a talking session with a psychologist regarding thoughts about treatment. This session is designed to explore thoughts about behavioral health therapy for suicidality. The session was administered by phone, initially and again one month later. Participants discussed current functioning and their thoughts about seeking help with the goal of modifying thoughts about treatment. This phone session lasted approximately 45 to 60 minutes.
16400337|NCT05077514|Behavioral|Active comparator: National Crisis Line|Participants assigned to Group B received information about the VA's National Crisis Line.
16400338|NCT05077293|Other|Best Practice Alert (BPA)|A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.
16400339|NCT05077293|Other|In-Basket Message|An In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure
16400340|NCT05077280|Radiation|stereotactic body radiotherapy|Stereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY
16400341|NCT05077280|Drug|Immunotherapy|Ipilimumab 1mg/kg every 6 weeks for 12 doses & nivolumab 360mg every 3 weeks for 2-3 years
16400342|NCT05077254|Biological|Pfizer-BioNTech COVID-19 Vaccine Booster|Administration: One dose administered intramuscularly.
16400343|NCT05077254|Biological|Moderna COVID-19 Vaccine Booster|Administration: One dose administered intramuscularly.
16400344|NCT05077254|Drug|SOC IS Regimen|Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
16400345|NCT05077254|Drug|SOC IS Reduction|Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
16400346|NCT05077189|Other|Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale|"4 items of the DC/TMD scale were used in this study to evaluate the TMJ disorders.
~Demographics Survey
~DC/TMD Symptom Questionnaire (SQ)
~Graded Chronic Pain Scale (GCPS)
~Jaw Functional Limitation Scale-20 (JFLS-20)"
16400347|NCT05076812|Diagnostic Test|measure plasma level of interleukin 38 by ELISA kit|draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
16400348|NCT05075694|Behavioral|Therapeutic Touch|Therapeutic Touch
16400349|NCT05075694|Other|Mimic touch|Mimic Touch
16400350|NCT05073939|Drug|Oral Oxytocin|Administration of oxytocin (24 international units) orally
16400351|NCT05073939|Drug|Oral Placebo|Administration of placebo orally
16400352|NCT05073601|Diagnostic Test|ELISA,DNA extraction|quantitative measurement of (Thyroid stimulating hormon (TSH), free triiodothyronine (FT3)& Free tetraiodothyronine(FT4)) measured using ELISA . Serum 25-OH vitamin D measured using ELISA. Serum 25-OH vitamin D will be classified based on 2012 American Endocrine Society guidelines into deficient (< 20ng/ml), insufficient ( 21 -30 ng/ml) and sufficient (> 30 ng/ml).vitamin D receptor polymorphisms was done in 3 steps: a) DNA extraction from whole blood using Gene Jet gene DNA Purification kits . b) PCR: three Vitamin D receptor polymorphisms were tested [Taq I (restriction enzymes according to single nucleotide polymorphism ) (rs731236), Apa I (rs7975232) and Bsm I (rs1544410)] using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Genomic DNA was amplified using certain primers
16400353|NCT05070299|Behavioral|Psychosexual Educational Partner Program (PEPP)|A communication and intimacy promotion kit consisting of three modules devoted to information sharing, partner communication and activities for building intimacy.
16400354|NCT05069753|Procedure|Immediate sequential bilateral cataract surgery (ISBCS)|Surgery on both eyes will be performed on the same day as separate procedures: Once surgery on the first eye is completed, a new sterile procedure on the second eye will commence.
16400355|NCT05069753|Procedure|Delayed sequential bilateral cataract surgery (DSBCS)|The group will undergo bilateral cataract surgery on two separate days with a time period of one week between the two procedures.
16400356|NCT05069597|Drug|CREON|Capsule; Oral
16400357|NCT05068726|Drug|18F Fluoroestradiol Radiopharmaceutical with PET/CT|Administration of one dose of 18F FES for PET/CT imaging
16400358|NCT05068258|Procedure|Lymphovenous bypass, including lymphaticovenular anastomosis/implantation|Lymphovenous bypass (LVB) is a supermicrosurgical technique by diverting lymphatic drainage into venous system. Simultaneously, we performed LVB at ipsilateral foot dorsum and debride the VLUs and resurface the wound primarily or by skin graft depending on defect size.
16400359|NCT05067088|Other|CPAP (all patients receive CPAP as part of routine clinical care)|Continuous positive airway pressure
16400360|NCT05066009|Device|NextSense EEG-enabled earbuds|Each NextSense EEGBud device comes with a custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. A unique custom mold is created employing a 3D printer to capture the geometry of a patients' ear and external auditory canal with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit, and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, and head and eye movements.
16400361|NCT05066009|Device|Ellcie Healthy eyeglasses|Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.
16400362|NCT05066009|Other|Drug Holiday|Participants will not take their prescribed wakefulness promoting medication(s) for one day to complete the study assessments. Medications typically used to promote wakefulness include amphetamine salts (Adderall), armodafinil (Nuvigil), clarithromycin (Biaxin), flumazenil, methylphenidate (Ritalin), and modafinil (Provigil).
16400363|NCT05065125|Device|digital single-operator cholangioscopy|"Duodenoscope passes through esophagus and stomach to the papilla of Vater
~SpyScope DS Catheter passes through the duodenoscope and into common bile duct
~After direct visualization of anastomosis site stricture, guidewire is passed through SpyScope DS Catheter above the stricture site."
16400364|NCT05063331|Procedure|Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCP+SCH)|Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
16400365|NCT05063331|Procedure|Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)|The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
16400366|NCT05063305|Dietary Supplement|Probiotic|The probiotic to be used in the study is in capsule form and consists of 12 bacterial strains and 10-billion colony forming unit (CFU). The product consists of the following bacterial strains and species: Bifidobacterium infantis ATCC SD 6720, Bifidobacterium bifidum ATCC SD 6576, Bifidobacterium breve ATCC SD 5206, Bifidobacterium lactis ATCC SD 5220, Bifidobacterium longum ATCC SD 5588, Lactobacillus acidophilus DSM 32754, Lactobacillus casei ATCC SD5213, Lactobacillus paracasei ATCC SD 5275, Lactobacillus plantarum ATCC SD 5209, Lactobacillus reuteri ATCC SD 6689, Lactobacillus rhamnosus ATCC 53103, Lactobacillus salivarius ATCC SD 5208) in combination with the prebiotic, xylooligosacharide (XOS).
16400367|NCT05063305|Dietary Supplement|Placebo|A placebo, that will be indistinguishable in appearance to the probiotic, will be provided to half of all study participants for the length of the trial. It will contain the following ingredients: Microcrystalline cellulose, magnesium stearate, a vegetarian capsule, and silicon dioxide. The probiotic will be manufactured by MeriCal.
16400368|NCT05063006|Other|Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.|Optimal resting LVAD speed settings is defined as periodic aortic valve opening while maintaining the central position of the intraventricular septum, minimizing mitral regurgitation, and preserving the mean systemic blood pressure above 65 mmHg. The aim is to achieve an aortic valve opening ratio of around 25-33% by changing the pump speed at resting conditions.
16400369|NCT05063006|Other|Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.|During the modified speed exercise, when the aortic valve opening ratio rises above 50%, the pump speed is increased by 100 revolutions per minute (RPM). As the aortic valve remains closed the RPM is lowered by 100. Speed increment is not greater than 100 RPM per 45 seconds to enable an echocardiographic analysis of resulting changes and prevent suction events. There is no determined target speed, neither per time period nor maximal.
16400374|NCT05061173|Other|Aerobic exercise training Group|Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 30 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 30 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 30 minutes
16400375|NCT05061173|Other|Resistance Exercise Training Group|"Resistive Exercises includes (a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction.
~At Week 1-2, 10 repetitions 1 set, 3 days/week, for 30 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 30 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 30 minutes"
16400376|NCT05061173|Other|Combined Exercise Training Group|"Combined Exercise training includes [Aerobic: Treadmill walking + Resistive Training: a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction] Time will be reduced to 15 minutes for both trainings in respective weeks. Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 15 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 15 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 15 minutes
~Resistive Exercises At Week 1-2, 10 repetitions 1 set, 3 days/week, for 15 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 15 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 15 minutes"
16400377|NCT05060627|Drug|Belantamab mafodotin|"In phase 1:
~Dose level -1: Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W
~Dose level 1,2,3: Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W In phase 2: maximum tolerated dose (MTD) of the combination"
16400378|NCT05060627|Drug|Carfilzomib|"In phase 1:
~Dose level -1, 1: Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W.
~Dose level 2: Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W
~Dose level 3: Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W.
~In phase 2: maximum tolerated dose (MTD) of the combination"
16400379|NCT05060627|Drug|Dexamethasone|Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old., Q4W
16400380|NCT05060562|Other|COVID 19 positive|Diagnosed as COVID 19 patient using Real-Time Polymerase Chain Reaction (RT-PCR) with the nasopharyngeal swab, or Rapid Antigen test of nasopharyngeal swab with suggestive symptoms.
16400381|NCT05060562|Other|COVID 19 negative|Suspected COVID 19 patients who were tested negative using either Real-Time Polymerase Chain Reaction (RT-PCR) with the nasopharyngeal swab, or Rapid Antigen test of nasopharyngeal swab.
16400382|NCT05060133|Procedure|Orthognathic Surgery|Surgical corrections of dentofacial deformities and malocclusions.
16400383|NCT05060042|Other|Whole body vibration group|WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week
16400384|NCT05060042|Other|Bilateral proprioceptive training|"Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints.
~In 4th week progressive balance training will be done with same frequency and duration.
~Tai chai exercises will be given for 20 mints 3 times a week"
16400386|NCT05058820|Other|Post Facilitation stretch|Hot pack 10 mins/ 1set/ (3 days/ week), TENS 10 mins/ 1 set/ (3 days/ week), Post facilitation stretch 15 secs isometric hold/ 15 secs stretch/ 30 secs relax/ 5 reps/ 1 set/ (3 days/ week), Deep friction massage 5 minutes/ (3 days/ week). A total of 6 weeks (18 sessions, 3 days/ week) were given each consisting of 30 mins.
16400387|NCT05058820|Other|Active Isolated Stretching|Hot pack 10 mins/ 1set/ (3 days/ week), TENS 10 mins/ 1 set/ (3 days/ week), Active Isolated Stretching 2 secs hold/ 10 reps/ 1 set/ (3 days/ week), Deep friction massage 5 minutes/ (3 days/ week). A total of 6 weeks (18 sessions, 3 days/ week) were given each consisting of 30 mins.
16400388|NCT05058807|Other|Whole body vibration group|"Experimental Group will receive WBV training and balance exercises under the supervision of a physical therapist by using a vibration platform. Balance exercises include:
~Double leg stance with eyes open and eyes closed 10 Reps * 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps, with 30 sec rest interval
~WHOLE BODY VIBRATION:
~The patient stood on the platform with his/her feet barefoot shoulder width and stared at the front, delivered on a side alternating vibration platform in an intermittent way: five repetitions of 1 min vibration followed by a 1 min rest. The vibration frequency and amplitude were 20 Hz and 3.0 mm respectively.
~These outcomes will be evaluated at baseline, and after 4 week and at 8th week"
16400389|NCT05058807|Other|Tai Chi group|"Control group will receive Balance exercises include:
~Double leg stance with eyes open and eyes closed 10 Reps * 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps ,with 30 sec rest interval Yang style Tai chi exercise which consist of 10 positions. 1. Hold the ball ward off 2: Grasping the sparrows tail left; 3.Grasping the sparrows tail Right;; 5.Repulse Monkey; 6. Part wild horse's Mane; 7.Brush knee Twist step; 8.Lift kick left; 9.Lift kick Right; 10.Cross hands with double leg stance
~1st and 2nd week will last for 5reps, 3rd and 4th week will last for 10reps,5th and 6th week will last for 15reps,7th and 8th week will last for 20reps, starting with 10 minutes warming- up and ending with 10 minutes cool-down. These outcomes will be evaluated at baseline, and after 4 week and at 8th week"
16400390|NCT05058794|Other|Blood flow Restriction/Resistance Training|During each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and limb occlusion pressure (LOP) was calculated in the body position that the Blood flow Restriction (BFR) stimulus would be applied. Blood Flow Restriction BFR pressure was set at 50% occlusion. Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees.
16400391|NCT05058794|Other|Conventional Therapy Group|Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.participants will perform 2 sets with 15 repetitions in (0 to 90 degree.)
16400392|NCT05056168|Other|Dermatology-Specific Treatment Satisfaction Instrument|Study subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients' preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms.
16400393|NCT05053490|Other|Static Stretching|Static stretches are those in which you stand, sit or lie still and hold a single position for a period of time.
16400394|NCT05053490|Other|dynamic stretching|Dynamic stretching involves making active movements that stretch the muscles to their full range of motion.
16400396|NCT05052801|Drug|Bemarituzumab|Intravenous (IV) infusion
16400397|NCT05052801|Drug|mFOLFOX6|mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
16400398|NCT05052801|Drug|Placebo|IV infusion
16400401|NCT05049590|Biological|Acute normovolemic hemodilution (ANH)|A blood conservation technique that removes whole blood (~8-10cc/kg) from a patient in the operating room prior to incision.
16400402|NCT05047731|Drug|Antihypertensive medication|Antihypertensive medication will be deprescribed to a blood pressure of 140 ±5 mmHg following the study algorithm.
16400403|NCT05047094|Device|Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
16400404|NCT05047094|Drug|Pembrolizumab|200 mg administered as an intravenous infusion over 30 minutes every 3 weeks
16400405|NCT05044221|Other|Former ICU patient and caregiver workshops|In depth interviews and workshops will be conducted with individuals enrolled in the study.
16400406|NCT05044221|Other|Health care professional workshops|In depth interviews and workshops will be conducted with individuals enrolled in the study.
16400407|NCT05042206|Biological|Cellgram-CKD|Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease
16400408|NCT05039840|Drug|SAR441344 IV|Pharmaceutical form: solution Route of administration: Intravenous infusion
16400409|NCT05039840|Drug|SAR441344 SC|Pharmaceutical form: solution Route of administration: subcutaneous injection
16400410|NCT05039840|Drug|Placebo IV|Pharmaceutical form: solution Route of administration: Intravenous infusion
16400411|NCT05039840|Drug|Placebo SC|Pharmaceutical form: solution Route of administration: subcutaneous injection
16400412|NCT05037409|Drug|PF-06823859|low dose or high dose intravenous infusion
16400413|NCT05037409|Drug|Placebo|Intravenous infusion
16400416|NCT05036343|Device|InPen®|A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten.
16400427|NCT05032820|Drug|Lenalidomide and bb2121|Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x106 cells. Maintenance lenalidomide, starting at 10mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression.
16400428|NCT05032703|Device|Arm ergometer|"The conventional physical therapy program included three sets of exercises as follows:
~Flexibility exercises to restore joint mobility of soft tissues. Static and dynamic balance exercise. Functional walking exercises."
16400429|NCT05029414|Procedure|Endovascular Therapy|Endovascular treatment of stroke is the non-surgical treatment for the sudden loss of brain function due to blood clots. The blood clot is removed from the blood via devices (i.e. stent-retriever, aspiration catheters and balloon guide) to achieve revascularization.
16400787|NCT04727138|Other|Food Effect|Fed/Fasted
16400443|NCT05027789|Behavioral|Self-Guided|People in this arm will come to 15 information sessions. These sessions will provide training and education on memory support strategies and healthy lifestyles. You will decide how you want to implement this information into your daily life.
16400444|NCT05027789|Behavioral|Structured Group|People in this group will come to 15 information sessions. The study will provide recommended behavior targets (like how much exercise you should have each week). Participants in this group will either receive an iPad or have a special application installed on their own personal device. They will receive training on how to use the application, and will be asked to use the application to record their activities and receive reminders.
16400445|NCT05023993|Other|Exercise Intervention|Complete home exercise
16400446|NCT05023993|Dietary Supplement|Nicotinamide Riboside|Given PO
16400447|NCT05022615|Diagnostic Test|Topcon Camera|Standard 7 field imaging
16400448|NCT05022615|Diagnostic Test|Optos Camera|Ultrawide field imaging
16400449|NCT05022615|Diagnostic Test|Clarus Camera|Ultrawide field imaging
16400452|NCT05020392|Drug|BTK inhibitor+ Fludarabine + Cyclophosphamide + CAR-T-CD19 Cells|BTK inhibitor from enrollment to 90 days after CAR-T-CD19 infusion. Low dose fludarabine and cyclophosphamide on day -5 to -3. CAR-T-CD19 cells (2*10^6 to 4*10^6 cells/kg) on day0.
16400453|NCT05020392|Drug|Fludarabine + Cyclophosphamide + CAR-T-CD19 Cells|Low dose fludarabine and cyclophosphamide on day -5 to -3. CAR-T-CD19 cells (2*10^6 to 4*10^6 cells/kg) on day0.
16400454|NCT05019105|Drug|Placebo|Oral matching placebo
16400455|NCT05019105|Drug|ALKS 1140|Active oral dose of ALKS 1140
16400458|NCT05016245|Combination Product|TheraSphere™ Yttrium-90 Glass Microspheres|"TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq.
~TheraSphereTM is supplied with the following accessories:
~Administration Set Administration Accessory Kit"
16400459|NCT05016245|Procedure|conventional Transarterial Chemoembolization(cTACE)|conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.
16400460|NCT05015335|Drug|Adalimumab|ADA 40mg q2w
16400461|NCT05015335|Drug|Methotrexate|MTX 10mg qw
16400462|NCT05014672|Drug|Setanaxib|Oral tablets, 400mg per tablet
16400463|NCT05014672|Drug|Placebo|Oral tablets
16400469|NCT05008510|Drug|Sabizabulin|Sabizabulin (Veru-111)
16400470|NCT05008510|Drug|Sacituzumab Govitecan-hziy|Sacituzumab govitecan-hziy
16400471|NCT05008510|Drug|Sabizabulin/Sacituzumab govitecan-hziy Combo|Sabizabulin/Sacituzumab govitecan-hziy Combo therpy
16400472|NCT05006573|Biological|Benralizumab|Benralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
16400473|NCT05006573|Biological|Placebo to Benralizumab|Matching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
16400474|NCT05005832|Other|multi day walking|Over the course of 14 days, the pilgrims will cover a distance of about 300 km.
16400478|NCT05001516|Drug|LM-302|All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-302 intravenous infusion on day 1 until meet the criteria of treatment discontinuation or withdraw, whichever occurs earlier.
16400479|NCT05000957|Device|Laser Treatment|"Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1.5 mJ.
~General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50 percentage (%) overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm, from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 50-100 milliseconds (ms), pause between packets of 50-100 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.
~The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth."
16400480|NCT05000957|Diagnostic Test|Blood analysis|Taking blood from a vein for clinical blood analysis, glucose test, hepatitis B, C viruses, human immunodeficiency viruses and syphilis test, blood clotting tests, blood type and rhesus factor determination (to include the participant in the study).
16400481|NCT05000957|Diagnostic Test|Сlinical urine test|Urine sampling for Clinical urine test (to include the participant in the study).
16400482|NCT05000957|Diagnostic Test|Electrocardiography|Electrocardiography investigation to determine cardiac abnormalities (to include the participant in the study).
16400483|NCT05000957|Diagnostic Test|Vaginal smear|Vaginal smear for flora investigation, oncocytology (to include the participant in the study).
16400484|NCT05000957|Diagnostic Test|Colposcopy|Colposcopy investigation to determine pre-malignant and malignant lesions of cervix, vagina or vulva (to include the participant in the study).
16400485|NCT05000957|Diagnostic Test|Pelvic ultrasound|Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
16400486|NCT05000957|Diagnostic Test|Doppler ultrasonography|Ultrasound investigation for assessing blood flow in the tissues of vulva region (to evaluate procedure efficiency).
16400487|NCT05000957|Diagnostic Test|Vaginal Health Index|Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. Potential of hydrogen (pH) will be investigated by test-lines paper (to evaluate procedure efficiency).
16400488|NCT05000957|Diagnostic Test|Biopsy of the vaginal wall|Sampling of the vaginal wall material in the posterior fornix area including the mucous membrane and muscle layer will be performed during colporrhaphy or any pelvic surgical procedure for histological, immunohistochemical studies, and optical coherence tomography (elastography) (to evaluate procedure efficiency)
16400489|NCT05000957|Diagnostic Test|The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire|The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
16400490|NCT05000957|Diagnostic Test|Pelvic Floor Distress Inventory Questionnaire|Pelvic Floor Distress Inventory Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
16400491|NCT05000957|Diagnostic Test|International Consultation on Incontinence Questionnaire - Short Form|International Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
16400492|NCT05000957|Diagnostic Test|Pelvic Floor Impact Questionnaire|Pelvic Floor Impact Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
16400493|NCT05000957|Procedure|Anterior and/or posterior colporrhaphy|Surgical procedure to repair pelvic organ prolapse followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).
16400494|NCT05000957|Procedure|Pelvic surgical procedure|Any pelvic surgical procedure which do not affect condition of vagina, vulva and paraurethral region followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).
16400495|NCT05000957|Other|Physical examination|Pelvic examination (to include the participant in the study and observe throughout the study)
16400496|NCT05000957|Other|Сonsultation|Сonsultation of a therapist about the absence of contraindications for surgical treatment (to include the participant in the study)
16400497|NCT05000502|Behavioral|Home-based exercise intervention|A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.
16400498|NCT04993677|Drug|SEA-CD40|Given into the vein (IV; intravenously); schedule is cohort-specific
16400499|NCT04993677|Drug|pembrolizumab|Given by IV; schedule is cohort-specific.
16400500|NCT04993677|Drug|pemetrexed|Given by IV on Day 1 of each 21-day cycle.
16400501|NCT04993677|Drug|carboplatin|Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.
16400545|NCT04964934|Drug|Anastrozole placebo|Dosage formulation: anastrozole placebo tablets will be administrated orally.
16401083|NCT04310007|Biological|Nivolumab|Given IV
16400509|NCT04987762|Drug|Adhansia XR|Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)
16400510|NCT04985851|Drug|durvalumab + anlotinib|Approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease.
16400511|NCT04985851|Drug|Durvalumab|durvalumab
16400512|NCT04980534|Dietary Supplement|Viusid and Asbrip|Patients will be assigned to receive daily oral doses of 4.5gr of Viusid and 10 ml of Asbrip every 8 hours and standard care.
16400513|NCT04980534|Drug|COVID-19 Standard Therapy|Patients will be assigned to receive the standard therapy for COVID-19 disease: Antibiotic, Antivirals, Analgaesic, Anti-inflammatory drugs.
16400514|NCT04978298|Other|Placebo|Placebo
16400515|NCT04978298|Drug|Rasigiline|Rasigiline
16400516|NCT04978298|Drug|Phenelzine|Phenelzine
16400517|NCT04978298|Drug|Ozanimod|Ozanimod
16400518|NCT04977037|Device|Active tDCS|Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
16400519|NCT04977037|Device|Sham tDCS|Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
16400520|NCT04976257|Procedure|Angiogram|Undergo angiogram
16400521|NCT04976257|Procedure|Catheterization|Undergo prostatic arterial catheterization
16400522|NCT04976257|Drug|Gallium Ga-labeled PSMA-11|Given IV and IA
16400523|NCT04976257|Procedure|Positron Emission Tomography|Undergo PET scan
16400524|NCT04974489|Behavioral|Emotion-based messages about the harm of VLNC|Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
16400525|NCT04974489|Behavioral|Continued-harm-framed messages about the harm of VLNC|Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
16400526|NCT04974489|Behavioral|Myth-refuting messages about the harm of VLNC|Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
16400527|NCT04974489|Behavioral|Control messages about littering|Participants in this arm will receive 3 control messages about littering during the survey data collection.
16400528|NCT04973891|Drug|Canagliflozin combined with metformin|"Canagliflozin, a novel glucose-lowering medication, has been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events.
~Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS."
16400532|NCT04971044|Behavioral|COACH|Multi-Level Behavioral Intervention
16400533|NCT04971044|Behavioral|School Readiness Intervention|Multi-Level Language and School Readiness Intervention (Control Group)
16400536|NCT04969198|Drug|Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)|Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
16400538|NCT04965272|Drug|Cariprazine 0.75 mg/day|Oral Capsule
16400539|NCT04965272|Drug|Cariprazine 1.5 mg/day|Oral Capsule
16400540|NCT04965272|Drug|Cariprazine 3.0 mg/day|Oral Capsule
16400541|NCT04965272|Other|Placebo|Oral Capsule
16400542|NCT04964934|Drug|AZD9833|Dosage formulation: AZD9833 tablets will be administered orally
16400543|NCT04964934|Drug|AZD9833 Placebo|Dosage formulation: AZD9833 placebo tablets will be administrated orally.
16400544|NCT04964934|Drug|Anastrozole|Dosage formulation: anastrozole tablets will be administered orally.
16400547|NCT04964934|Drug|Letrozole placebo|Dosage formulation: letrozole placebo tablets will be administered orally.
16400548|NCT04964934|Drug|Palbociclib|Dosage formulation: palbociclib tablets/capsules will be administered orally
16400549|NCT04964934|Drug|Abemaciclib|Dosage formulation: abemaciclib tablets will be administered orally
16400550|NCT04964934|Drug|Luteinizing hormone-releasing hormone (LHRH) agonist|Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
16400551|NCT04958005|Diagnostic Test|ELISA|Enzim linked immunoabsorbant assay
16400552|NCT04955132|Behavioral|E-learning|The participants in the experimental arm will be able to use a food allergy e-learning tool, that provides comprehensive knowledge of the most common food allergies (milk, egg and wheat), their management and dietary guidelines.
16400553|NCT04953052|Drug|Imatinib Mesylate|An isotonic sterile solution of imatinib.
16400554|NCT04953052|Drug|Placebo|An isotonic sterile solution
16400555|NCT04952376|Behavioral|SMS delivery of information|Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. Links to information or phone for scheduling will be provided. Messages mimic the clinic's usual practice of information delivery to patients
16400556|NCT04952376|Behavioral|Personalized text message delivery of information|Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. The SMS message is personalized as a recommendation from the primary care clinician
16400557|NCT04952376|Behavioral|Interactive or 2-way SMS delivery of information|This intervention is same as in the Arm 2 using personalized messaging from the PCP. In addition, patients are given interactive or 2-way SMS options to obtain additional information about COVID vaccine and answers to frequently asked questions.
16400560|NCT04949256|Drug|Pembrolizumab|400 mg once every 6-week-cycle, via IV infusion.
16400561|NCT04949256|Drug|Lenvatinib|8 mg QD (induction) or 20 mg QD (consolidation) via oral capsule.
16400562|NCT04949256|Drug|Cisplatin|80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy.
16400563|NCT04949256|Drug|5-FU|4000 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m^2 Q2W via bolus IV infusion followed by 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
16400564|NCT04949256|Drug|Oxaliplatin|85 mg/m^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
16400565|NCT04949256|Drug|Leucovorin|400 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
16400566|NCT04949256|Drug|Levoleucovorin|200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
16400567|NCT04948112|Device|real time continuous glucose monitor|CGM sensor will read blood glucose every 10 minutes
16400568|NCT04948112|Device|blinded continuous glucose monitor|CGM that records blood glucose but not visible to patient
16400571|NCT04943445|Drug|carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles|Patients without disease progression will proceed to the concurrent radioimmunotherapy phase of the trial.
16400572|NCT04943445|Radiation|Concurrent radio-immunotherapy: radiation therapy given concurrently with pembrolizumab 200 mg i.v. on day 1, every 21 days for 3 cycles.|Patients without disease progression will proceed to the consolidation immunotherapy phase of the trial.
16400573|NCT04943445|Drug|Consolidation immunotherapy: pembrolizumab 200 mg i.v. on day 1, every 21 days for 11 doses.|Consolidation immunotherapy
16400574|NCT04942158|Procedure|Non-instrumentation technique with use of CTZ paste|After local anesthesia and rubber dam isolation, the pulp chamber will be accessed. After the location of root canals entrance, an initial irrigation will be conducted using 1% sodium hypochlorite. Then, a paste containing two antibiotics (chloramphenicol and tetracycline) and zinc oxide and eugenol (CTZ paste) will be placed in the pulp chamber floor, into the root canal entrances. Then, a layer of glass ionomer cement will be placed, and the teeth will be restored with bulk-fil resin composite.
16400575|NCT04942158|Procedure|Instrumentation technique and filling with Zinc Oxide and Eugenol paste|After anesthesia and rubber dam isolation, pulp chamber will be accessed with burs, and the root canals entrance will be prepared using a Gates Glidden bur. The root canal length determination will be done subtracting 1 mm from the radiographic measurements performed on the different roots. The instrumentation will be performed with 21mm stainless steel endodontic hand K-files, with International Organization for Standardization (ISO) tip ranging from #08 to #35. Irrigation will be performed using 1% sodium hypochlorite. After the last file, a final irrigation will be conducted with ethylenediaminetetraacetic acid and tegentol (EDTA-T) and 0.9% sodium chloride solution, and the root canals will be dried with paper points. Then, the root canals will be filled with a Zinc Oxide and Eugenol paste (ZOE paste), inserted into the root canals with a lentulo spiral. A layer of glass ionomer cement will be placed, and the teeth will be restored with bulk-fil resin composite.
16400576|NCT04939428|Drug|Molnupiravir|Four molnupiravir 200 mg capsules taken by mouth.
16400577|NCT04939428|Drug|Placebo|Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.
16400578|NCT04936542|Biological|AboBoNT-A|AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)
16400579|NCT04936542|Biological|OnaBoNT-A|OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)
16400580|NCT04935944|Radiation|CBCT radiation|CBCT scanning
16400581|NCT04935762|Drug|CST-103, CST-107, matching placebo|CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
16400582|NCT04934072|Drug|FKS518|Participants will receive FKS518 via subcutaneous injection, every 26 weeks.
16400583|NCT04934072|Drug|US-licensed Prolia|Participants will receive US-licensed Prolia via subcutaneous injection, every 26 weeks.
16400594|NCT04931238|Drug|JS016|Single Intravenous Injection of JS016 with a dose of 50mg/kg
16400595|NCT04928846|Biological|Telisotuzumab Vedotin|Intravenous (IV) Infusion
16400596|NCT04928846|Drug|Docetaxel|IV Infusion
16400598|NCT04925648|Drug|Dasatinib|Dasatinib 100mg once daily orally for 14 Days
16400599|NCT04925648|Drug|Darolutamide|Darolumatide 600 mg twice daily orally for 14 Days
16400600|NCT04918160|Other|Exposure to the FICS annual meeting (June 9-11 2021, Paris Congress Center)|The study will compare COVID-19 screening nasal antigenic self-test (Boiron Auto Test Covid Nasal) positivity at D7 and COVID-19 symptoms in the 21 days between participants to the FICS annual meeting held in June 9-11 2021 in the Paris Congress Center (conference attendees / exposed) and healthcare professionals who did not attend the meeting (controls / not exposed).
16400603|NCT04915755|Drug|Niraparib|Niraparib will be administered.
16400604|NCT04915755|Drug|Placebo|Matching placebo will be administered
16400607|NCT04912856|Drug|XEN496|XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
16400608|NCT04912856|Drug|Placebo|Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
16400609|NCT04912830|Procedure|Tension-free vaginal tape|female incontinence surgery with polypropylene tape applied
16400610|NCT04908631|Device|Transcranial Direct Stimulation|Brain stimulation using low-intensity current via electrodes on scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable head gear with disposable, snap-in electrodes wihich can be applied at home without assistance.
16400611|NCT04908631|Other|Auditory Training Program|Web-based program uses consonant and vowel recognition and understanding sentences/conversations in quiet and in noise using different talkers, and other types of listening exercises.
16400612|NCT04907968|Drug|XMT-1536 (Upifitamab Rilsodotin)|XMT-1536 (Upifitamab Rilsodotin) will be administered on Day 1 of each 28 day cycle until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study
16400613|NCT04907968|Drug|Carboplatin|Carboplatin will be administered on Day 1 on each of the first six 28 day cycles.
16400614|NCT04907240|Device|GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)|Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
16400615|NCT04905134|Device|Nasopharyngoscope|Low-cost, flexible scope prototype will compared to rigid scope used as standard of care.
16400616|NCT04905069|Device|SpaceOAR Vue System|"The SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.
~The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time."
16400617|NCT04904471|Biological|Recombinant COVID-19 vaccine (Sf9 cells)|This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified by antigen isolation and added with aluminum hydroxide adjuvant for the prevention of COVID-19.
16400618|NCT04904471|Other|Placebo control|Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate) are consistent with the study vaccine and have been tested and qualified by National Institutes for Food and Drug Control.
16400622|NCT04902144|Other|Electronic Health Record Review|Medical data collected
16400623|NCT04902144|Other|Questionnaire Administration|Complete questionnaires
16400625|NCT04901806|Drug|PBI-200|PBI-200 will be administered orally over continuous 28-day cycles
16400626|NCT04899908|Radiation|Stereotactic Radiation|Focused radiation beams to treat tumors
16400627|NCT04899908|Drug|AGuIX gadolinium-based nanoparticles|Intravenous injection
16400628|NCT04899908|Other|Placebo|Intravenous infusion
16400629|NCT04899167|Other|MRI 1.5T and 3.0T|Magnetic Resonance Imaging for Renal Fibrosis
16400630|NCT04896866|Behavioral|Antimicrobial stewardship prospective audit and feedback|Audits are performed on weekdays, less statutory holidays, by members of the antimicrobial stewardship team consisting of infectious disease or antimicrobial stewardship physicians or pharmacists. Verbal and written feedback will be provided in real-time. Initial prospective audit and feedback (PAF) will occur on the day of enrolment. Follow-up PAF will occur weekly (+/-3 days to account for weekends or statuary holidays) and ad-hoc if a new antibacterial is prescribed, until the primary end-point. Appropriateness will be assessed based on local clinical practice guidelines. Only antibacterials will be audited. Prescriptions will be excluded from PAF if they are single doses or discontinued prior to PAF. Prescriptions will be also be excluded from PAF and the final analysis if being used for surgical or medical prophylaxis.
16400632|NCT04895722|Biological|Pembrolizumab|400 mg pembrolizumab administered via IV infusion.
16400633|NCT04895722|Biological|Pembrolizumab/Quavonlimab|Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
16400634|NCT04892121|Other|Prevention exercises|Participants will have to follow a warm-up prevention program (15 minutes) twice a week
16400642|NCT04881487|Radiation|Additional stereotactic body radiation therapy|5 fractions of 8 Gray stereotactic body radiation therapy in addition to standard of care.
16400643|NCT04880863|Drug|NAP (Naptumomab estafenatox)|Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP is administered on Days 1-4 of each treatment cycle.
16400644|NCT04880863|Drug|Docetaxel|Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycle.
16400645|NCT04880863|Drug|Obinutuzumab|Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
16400646|NCT04880577|Drug|TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY]|The study is designed to add on TAF to anti-CD20 therapies
16400647|NCT04880577|Drug|Placebo|Placebo arm
16400648|NCT04877327|Procedure|Ablation|Cryotherapy and radiofrequency
16400649|NCT04872140|Dietary Supplement|Low phytate pea powder|Exercise performance with low phytate pea powder
16400650|NCT04872140|Dietary Supplement|Regular pea powder|Exercise performance with regular pea powder
16400651|NCT04872140|Dietary Supplement|Placebo (maltodextrin)|Exercise performance with placebo (maltodextrin)
16400652|NCT04871113|Biological|GSK3810109A|GSK3810109A will be available as sterile aqueous solution.
16400655|NCT04859296|Drug|Placebo|Vaporized placebo
16400656|NCT04859296|Drug|Low CBG|Vaporized CBG (5 mg)
16400657|NCT04859296|Drug|High CBG|Vaporized CBG (15 mg)
16400658|NCT04859296|Drug|Low THC|Vaporized THC (5 mg)
16400659|NCT04859296|Drug|High THC|Vaporized THC (15 mg)
16400660|NCT04856657|Device|Transcranial alternating current stimulation|The tACS will be applied with a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (25 cm²) applied to the back of the head. The anode will be located at Oz and the cathode will be located at Cz.
16400661|NCT04854265|Other|Mindfulness Meditation|Mindfulness meditation will include mindfulness based stress reduction program, Qigong, Tai Chi exercise, Yoga, and Pranayama breathing exercise.
16400665|NCT04847232|Drug|Sodium Zirconium Cyclosilicate (SZC)|Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
16400666|NCT04847232|Drug|SZC Placebo|Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
16401084|NCT04310007|Drug|Paclitaxel|Given IV
16400674|NCT04844281|Device|Precision1® Daily Disposable Toric Contact Lens|Soft, toric contact lens used to correct distance vision and astigmatism.
16400675|NCT04837196|Drug|ASP7517|Intravenous (IV)
16400676|NCT04837196|Drug|Pembrolizumab|Intravenous (IV)
16400677|NCT04829214|Drug|OTO-313|Single intratympanic injection
16400678|NCT04829214|Drug|Placebo|Single intratympanic injection
16400679|NCT04822181|Drug|Semaglutide|Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
16400680|NCT04822181|Drug|Placebo|Placebo administrated subcutaneously (under the skin) once weekly.
16400685|NCT04816526|Biological|Descartes 08|Car T-cells
16400687|NCT04814264|Biological|Red blood cells|All transfused red blood cells will be obtained from Canadian Blood Services and will be the standard red blood cell products currently provided in Canada.
16400688|NCT04810390|Drug|Bilastine|Ophthalmic solution 0.6%
16400689|NCT04810390|Drug|Placebo|Ophthalmic solution
16400692|NCT04806347|Biological|TCRαβ+/CD19+ depleted Hematopoietic stem cell (HSC) graft|After undergoing a disease specific conditioning regimen (standard of care), participants will receive peripheral blood stem cell transplant from a haploidentical donor or closely matched unrelated donor, depleted of TCR αβ+ and CD19+ cells using the CliniMACS TCR α/β-biotin and CD19 Systems.
16400693|NCT04806347|Device|CliniMACS® System|The CliniMACS Cell Selection System is based on magnetic-activated cell sorting mechanism. The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures.
16400694|NCT04802720|Other|Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)|"The sessions are outlined as follow:
~psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
~coping effectiveness training (Session 2);
~identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
~challenging and restructuring unhelpful cognitions (Session 4);
~behavioral activation within the limitations of the caregiving context (Session 5);
~problem-solving (Session 6);
~communication strategies and assertiveness training (Session 7);
~consolidating gains, maintenance, and relapse prevention (Session 8)."
16400695|NCT04802720|Other|Emotion Regulation Therapy for Cancer Caregivers (ERT-C)|"The sessions are outlined as follow:
~psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
~attention regulation skills training (Sessions 1-2);
~training in metacognitive skills (Sessions 3-4);
~exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
~consolidating gains, taking larger proactive steps, and relapse prevention (Session 8)."
16400696|NCT04802356|Drug|Belantamab mafodotin|"Dose of 2.5 mg/kg/every 8 weeks on day 1, intravenously, Induction: three induction cycles with belantamab mafodotin in combination with VRd.
~Consolidation: one cycle after 90 days of transplantation with belantamab mafodotin in combination with VRd.
~Maintenance: belantamab mafodotin in combination with lenalidomide until disease progression, patients withdrawal, death or up to two years, whichever occurs first"
16401085|NCT04310007|Biological|Ramucirumab|Given IV
16400697|NCT04802356|Drug|Bortezomib|Dose of 1.3 mg/m2, on days: 1, 4, 8 and 11 of every 28-day cycle. Subcutaneous administration Induction: 6 cycles Consolidation: 2 cycles
16400698|NCT04802356|Drug|Lenalidomide|Dose of 25 mg/day on days 1-21 of every 28-day cycle. Oral administration. Induction: 6 cycles Consolidation: 2 cycles Maintenance: 10 mg/day on days 1-21 continuously (may increase up to 15 mg/day) until disease progression, patients withdrawal, death, whichever occurs first
16400699|NCT04802356|Drug|Dexamethasone|Dose of 20 mg on days: 1, 2, 4, 5, 8, 9, 11 and 12 of every 28-day cycle. Oral administration Induction: 6 cycles Consolidation: 2 cycles
16400700|NCT04802356|Procedure|Autologous stem cell transplant (ASCT)|High-dose melphalan (200 mg/m2) and ASCT will be performed as per routine practice
16400711|NCT04788511|Drug|Semaglutide|"Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.
~Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks."
16400712|NCT04788511|Drug|Placebo (semaglutide)|"Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.
~The study will last for approximately 59 weeks."
16400713|NCT04788251|Other|Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)|"The modified OEP is a group exercise programme that consists of progressive strength and balance exercises led by trained exercise leaders (fitness instructors or health coaches). The supervised sessions will be conducted twice a week (1 hour each) for 7 weeks. Participants will be given an exercise booklet and encouraged to exercise at home.
~The modified SOP is a group fall prevention programme that consists of exercise sessions and discussions on various falls prevention aspects facilitated by a trained programme leader and supported by programme facilitators and peer facilitators. The supervised sessions will be conducted once a week (2 hours each) for 7 weeks. Participants will be given homework and encouraged to exercise at home. In addition, there will be an optional home visit (Week 11), a 1-hour booster session (Week 19) and a telephone call (Week 31)."
16400714|NCT04788251|Other|Wait-list control|To receive fall prevention resources while waiting for their programme to start
16400715|NCT04781322|Drug|Alirocumab|Alirocumab is a human monoclonal antibody (IgG1) that binds to and inhibits PCSK9 and was approved by the FDA in July of 2015. PCSK9 binds to and promotes degradation of low-density lipoprotein receptors (LDLR) on hepatocyte membranes.
16400716|NCT04781322|Other|Placebo|Heavy drinking healthy volunteers
16400721|NCT04777357|Drug|Cariprazine|Oral Capsule
16400722|NCT04777357|Drug|Placebo|Oral Capsule
16400724|NCT04776148|Drug|pembrolizumab|IV infusion
16400725|NCT04776148|Drug|lenvatinib|oral capsule
16400726|NCT04776148|Drug|regorafenib|oral tablet
16400727|NCT04776148|Drug|TAS-102 (trifluridine and tipiracil)|oral tablet
16400728|NCT04773834|Other|Digital diabetes prevention program (dDPP)|The digital diabetes prevention program is through the Noom app, and the three devices (Fitbit physical activity tracker, Fitbit weight scale, and self-check hemoglobin a1c kit). This is a one year diabetes prevention program where participants will be expected to participate in 5 to 7 interviews over a 18 month period.
16400729|NCT04773834|Other|Adapted dDPP-EHR tool|This is a product of Phase 1 and 2 of this study where participants will receive detailed text messaging regarding their engagement levels in Noom app.
16400730|NCT04771962|Drug|DESFLURANE AND SEVOFLURANE|COMPARING THE EFFICACY IN MAINTAINANCE OF SPONTANEOUS GENERAL ANAESTHESIA USING AMBU AURA GAIN IN PEDIATRIC PATIENTS
16400731|NCT04767022|Device|Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)|Drug Coated Balloon
16400732|NCT04767022|Device|Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)|Drug Coated Balloon
16400733|NCT04766788|Other|Wearable devices, saliva samples, survey measures|Provide a baseline self-collected saliva sample, download and use the suite of apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0) and answer surveys that are delivered through the Roadmap 2.0 app at 4 time points (e.g., baseline, 1-month, 2-month, 3-month [end of academic semester]).
16400734|NCT04764097|Drug|Dapagliflozin|SGTL2 Inhibitor
16400735|NCT04764097|Drug|Placebo|Placebo
16400736|NCT04763330|Behavioral|Enhanced Usual Care (EUC)|Enhanced Usual Care (EUC) consists of Collaborative Safety Planning, a VA usual care practice. It is a tool that Veterans can use when they are in an acute suicidal crisis. The condition is considered enhanced because Veterans in this condition receive 6 sessions total, Safety Planning which is delivered in 1-2 sessions and 4-5 sessions of check-ins with a brief assessment. Safety Planning involves a worksheet completed by the patient in collaboration with a health provider.
16400785|NCT04727138|Drug|EXS21546 Granule in Capsule|EXS21546 Granule in Capsule
16400786|NCT04727138|Other|Midazolam|Interaction
16400737|NCT04763330|Behavioral|Problem Solving Therapy (PST) plus EUC|"Veterans randomized to this condition received EUC and PST. EUC is delivered in both conditions to ensure the safety of all Veterans enrolled in the study. In addition to EUC, Veterans in this condition receive PST, which teaches patients a structured planful problem solving approach to: 1) identify problems and set goals, 2) generate alternative solutions, 3) select a solution based on cost-benefit analysis, and 4) devise and implement a plan for the solution and assess its effectiveness in solving the problem. This contemporary PST protocol also teaches tool kits to address obstacles highly pertinent to the challenges faced by older Veterans with mental health disorders and active suicidal ideation: emotion dysregulation, hopelessness, and feeling overwhelmed by too much information (brain overload) or stress."
16400738|NCT04761627|Drug|Ustekinumab|Participants will receive subcutaneous (SC) injection of ustekinumab.
16400739|NCT04761627|Drug|ABP 654|Participants will receive SC injection of ABP 654.
16400740|NCT04761211|Device|smart bra|This is a patented infrared breast examination bra
16400759|NCT04755088|Drug|Surufatinib|Subjects to receive Surufatinib 300mg on Day 1
16400760|NCT04755088|Drug|Surufatinib|Subjects to receive Surufatinib 300mg on Day 1
16400761|NCT04755075|Drug|Surufatinib|Subjects to receive Surufatinib 250 mg on Day 1
16400762|NCT04755075|Drug|Surufatinib|Subjects to receive Surufatinib 250 mg on Day 1
16400763|NCT04754711|Dietary Supplement|Oral Nutritional Supplement|We will propose to the patients of group 1 several different oral nutritional supplements according to taste, and consistency of each child in order to optimize observance. Each of those different oral nutritional supplements will be adapted to the nutritional survey and the age of children without exceeding recommended intake of proteins, carbohydrates, lipids and micronutrients. Those patients will consume the Oral Nutritional Supplement during 12 months.
16400764|NCT04752735|Other|endovascular treatment|all enrolled patients must receive endovascular treatment.
16400766|NCT04743141|Drug|Rimegepant / BHV3000|BHV3000 (rimegepant) 75 mg or 50 mg ODT
16400767|NCT04740775|Device|LiquiBand Exceed|Cyanoacrylate glue for closure of surgical wounds
16400774|NCT04739423|Drug|CST-103, CST-107, matching placebo|CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
16400775|NCT04738149|Drug|Bimatoprost|Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
16400776|NCT04738149|Device|Excimer laser|Participants will be receiving excimer laser 2x a week for 12 weeks
16400777|NCT04738149|Device|Microneedling with a dermaroller|Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks
16400778|NCT04735718|Device|Cerviron|"Cerviron® ovules is a class IIb medical device used as adjuvant treatment in cervical lesions of mechanical origin. It favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.
~Moreover, it provides a strong hemostatic effect, as shown in multiple studies. Moreover, it contains collagen with nutritive, hydrating, healing and trophic effect. Collagen is structurally and functionally a key protein of the extracellular matrix which is also involved in forming the scars during the healing of conjunctive tissues, due to its chemotactic role. Many collagen bandages were developed to improve the repair of the wound, especially of non-infected, chronic, idle cutaneous ulcerations."
16400779|NCT04733222|Other|Perturbation training|"The treadmill perturbation training will be performed on a computer-controlled treadmill. The perturbation will be induced by fast forward (slip) or backward (trip) accelerations of the treadmill at specific gait cycle timings. The perturbations will be delivered randomly to enhance the unpredictability. A ceiling-mounted body-harness ensures the safety of the participants.
~Participants will be assigned to three initial sessions of treadmill slip- and trip-perturbation training on two days separated by a week and a booster-session after six months. On day 1, participants will first undergo a session 1 with 40 slip perturbations and then a session 2 with 40 trip perturbations. On day 2, participants will undergo a session 3 with 20 slip and 20 trip perturbations in random order. The booster-session after six months will be similar to session 3 (20 of each perturbation in random order)."
16400780|NCT04733222|Other|Treadmill walking|Participants allocated to the walking group will walk at a self-selected pace on a computer-controlled treadmill for the same amount of time as the treadmill perturbation training participants.
16400781|NCT04732494|Drug|Tislelizumab|Tislelizumab is a monoclonal antibody formulated for intravenous injection.
16400782|NCT04732494|Drug|Ociperlimab|Ociperlimab is a monoclonal antibody formulated for intravenous injection.
16400783|NCT04732494|Drug|Placebo|Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
16400784|NCT04727138|Drug|EXS21546 Powder for Oral Suspension|EXS21546 Powder for Oral Suspension
16400788|NCT04727138|Other|Placebo Powder for Oral Suspension|Placebo Powder for Oral Suspension
16400789|NCT04721015|Drug|ABBV-637|Intravenous (IV) Infusion
16400790|NCT04721015|Drug|Docetaxel|Intravenous (IV) Infusion
16400791|NCT04721015|Drug|Osimertinib|Oral Tablets
16400792|NCT04720729|Biological|Chemotherapy monitoring by circulating tumor DNA analysis|"During the screening step (2nd chemotherapy line, cycle 1) : at each time point (L2C1D1 & L2C1D15), 30 ml of blood will be drawn on special tubes with conservative suited for ctDNA analyses (e.g. STRECK® tubes).Then cell-free circulating DNA (cfcDNA) will be extracted from plasma following the manufacturer recommendations. cfcDNA will be quantified, and minimum 500-1000 copies will be analyzed by droplet digital PCR (ddPCR). Analyses will define if ctDNA could be detected during L2.
~For the interventional step, from L3 (3rd chemotherapy line) : 20 ml of blood will be drawn at L3C1D1 and L3C1D15. If ctDNA at D15 shows a major drop (> 40%) from D1, treatment will be continued. If ctDNA at D15 shows no major drop from D1, chemotherapy will be changed."
16400793|NCT04719533|Other|Pre-marking of episiotomy location|A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
16400794|NCT04714320|Drug|IONIS-AGT-LRx|Multiple doses of IONIS-AGT-LRx will be administered by SC injection.
16400795|NCT04714320|Drug|Placebo|IONIS-AGT-LRx-matching placebo will be administered by SC injection.
16400796|NCT04713995|Other|Dietary recommendations|Dietary recommendations based on microbiome analysis of samples will be given and expected to receive and report in ~3 months survey after following recommendations.
16400797|NCT04710615|Device|Synapse platform|"The Synapse platform made available to health professionals, is a virtual assistant capable of understanding the questions of natural language doctors and providing an answer by specifying the source of information used. This device also allows you to photograph a prescription and analyze it automatically to detect potential drug interactions.
~The Synapse platform offers a panel of functions to help the doctor to prescribe medication."
16400798|NCT04705532|Device|tDCS|Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA
16400799|NCT04705532|Device|Sham tDCS|Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
16400800|NCT04705532|Other|Music|Subjects will listen to their preferred music for 20 minutes
16400801|NCT04705532|Other|White noise|Subjects will listen to a white noise for 20 minutes
16400802|NCT04704505|Radiation|radium-223|Radium-223 is an alpha-particle-emitting bone-targeted therapy. All patients will receive Treatment with Radium-223 at a dose of 55 kBq per kilogram of body weight IV every 28 days, for 6 cycles,
16400803|NCT04704505|Drug|Bipolar Androgen Therapy (BAT)|All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.
16400804|NCT04701502|Dietary Supplement|Viusid|"Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally.
~Treatment duration: 21 days"
16400805|NCT04701502|Dietary Supplement|Asbrip|"Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally.
~Treatment duration: 21 days"
16400806|NCT04701502|Drug|Standard Care|Standard care for COVID-19
16400807|NCT04700878|Behavioral|Internet-based compassion course for stress managemant|A five week long, structured self-help program with weekly reports to, and feedback from a compassion-focused (CFT) therapist over the Internet. Includes traditional CFT-methods for stress-related problems.
16400808|NCT04700878|Behavioral|General Internet-based cognitive behavioural course for stress management|A five week long, structured self-help program with weekly reports to, and feedback from a cognitive-behavioral (CBT) therapist over the Internet. Includes traditional CBT-methods for stress-related problems.
16400809|NCT04700267|Drug|GLPG3970 film-coated tablet|GLPG3970 for oral administration
16400810|NCT04700267|Drug|Placebo film-coated tablet|Placebo for oral administration
16400814|NCT04699071|Drug|pembrolizumab and lenvatinib|"All patients will receive oral lenvatinib daily plus intravenous pembrolizumab 3-weekly.
~A cycle is 21 days. Allowances will be made for stepwise dose reductions of lenvatinib due to treatment-related toxicities.
~Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, (CTCAE) Version 5.0.
~Patients are planned to continue therapy until disease progression, intolerable toxicity, or withdrawal of patient consent."
16400815|NCT04698187|Drug|CMP-001|Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).
16400816|NCT04698187|Drug|Nivolumab|Nivolumab 360 mg IV is administered Q3W.
16400817|NCT04695119|Other|Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.|Collection of data, biomarker and echocardiography analysis will be centralized and blinded. Assessment of endpoints will be blinded.
16400819|NCT04691427|Device|Virtual Eye Rotation Vision Exercises (VERVE)|A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).
16400820|NCT04689529|Diagnostic Test|Preoperative imaging study|MRI, Breast ultrasound sonography, mammography
16400821|NCT04689360|Drug|elamipretide|Elamipretide is an aromatic-cationic tetrapeptide that readily penetrates cell membranes and transiently localizes to the inner mitochondrial membrane.
16400822|NCT04688775|Drug|Eptinezumab|Eptinezumab - concentrate for solution for infusion, intravenously
16400823|NCT04688775|Drug|Placebo|Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
16400824|NCT04688502|Other|High intensity interval training|High intensity interval training: 6 sets x 8 bench press, 10 pull-ups, and maximal number of box jumps (each set lasting 60 sec, with 4 minutes rest between sets)
16400825|NCT04688502|Other|Continuous exercise training|5 pull-ups, 10 push-ups, and 15 body-weight squats, repeated for 30 minutes
16400826|NCT04688307|Behavioral|Motivational interviewing|Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight
16400827|NCT04687774|Device|ExaltTM Model D Single-Use Duodenoscope|The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller.
16400829|NCT04685941|Drug|Drug-mediated hyperemia|Intracoronary bolus of at least 200 mcg of nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes. Operators are allowed to combine both drugs.
16400830|NCT04685941|Other|Flow-mediated hyperemia|Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.
16400831|NCT04681144|Drug|Radium-223-dichloride (Xofigo, BAY88-8223)|Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice
16400832|NCT04677751|Device|Acupuncture intervention|Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.
16400838|NCT04665037|Drug|Posaconazole IV 6 mg/kg|POS 6 mg/kg of body weight by IV infusion in a single dose on Day 1
16400839|NCT04665037|Drug|Posaconazole IV TBD|POS at a dose to be determined (TBD) by IV infusion twice daily on Day 1; and then once daily on Day 2 to a maximum 84 days
16400840|NCT04665037|Drug|Posaconazole PFS TBD|POS at a dose TBD, orally by PFS starting on Day 8 once daily for a maximum 84 days
16400841|NCT04662931|Drug|crizanlizumab|Crizanlizumab will be taken by IV infusion, at Week 1 Day 1, Week 3 Day 1 and all 4 weeks thereafter.
16400848|NCT04649671|Behavioral|Mobile health|"Perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening).
~Mobile application: Hepatocellular carcinoma by Second Doctor Wearable device: Dofit"
16400849|NCT04648826|Device|AeroEclipse II Breath Actuated Nebulizer|Patients will receive AZA via commercial device, AeroEclipse II Breath Actuated Nebulizer.
16400850|NCT04648826|Drug|Bintrafusp alfa|Bintrafusp alfa will be administered on Day 13 (+/- 3 days) of every 3-week cycle (i.e., Q3W [once every 3 weeks]) at a fixed intravenous dose of 2400 mg; Bintrafusp alfa does not start until cycle 2 of the phase I portion.
16400851|NCT04648826|Drug|Azacytidine|Patients will receive azacytidine (aersolized; via commercial AeroEclipse II Breath Actuated Nebulizer device) on 3 consecutive days in the first week of every 3-week cycle. Phase I: Azacytidine will be given at escalating doses. Phase II: Azacytidine will be given at the RP2D established in Phase I.
16400855|NCT04644029|Drug|Islatravir|Oral 60 mg tablet administered once monthly
16400856|NCT04644029|Drug|Placebo to FTC/TDF|0 mg tablet administered once daily
16400857|NCT04644029|Drug|FTC/TDF|Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate), administered orally once daily
16400858|NCT04644029|Drug|Placebo to ISL|0 mg tablet administered orally once monthly
16400863|NCT04634604|Drug|Bevacizumab|For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated.
16400864|NCT04634604|Procedure|Laser|For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed.
16400865|NCT04634578|Drug|Bevacizumab|"All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
~Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution."
16400866|NCT04632940|Drug|Pamrevlumab|pamrevlumab 35 mg/kg IV Q2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally
16400867|NCT04632940|Drug|Placebo|matching placebo IV Q2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally
16400868|NCT04631601|Drug|Acapatamab|Acapatamab will be administered as an intravenous (IV) infusion.
16400869|NCT04631601|Drug|Enzalutamide|Enzalutamide will be administered orally.
16400870|NCT04631601|Drug|Abiraterone|Abiraterone will be administered orally.
16400871|NCT04631601|Drug|AMG 404|AMG 404 will be administered as an intravenous (IV) infusion.
16400872|NCT04629417|Device|Smart Physiotherapy Activity Recognition System (SPARS)|Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.
16400875|NCT04622228|Drug|Atezolizumab|Atezolizumab will be administered by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.
16400876|NCT04622228|Drug|Cisplatin|Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m^2) after completion of atezolizumab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
16400877|NCT04622228|Drug|Carboplatin|Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
16400878|NCT04622228|Drug|Etoposide|Etoposide will be administered intravenously at a dose of 100 mg/m^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
16400879|NCT04622228|Radiation|Thoracic radiation therapy (TRT)|Participants will receive concurrent thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle.
16400880|NCT04622007|Drug|Tomivosertib|Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
16400881|NCT04622007|Biological|Pembrolizumab|Subjects will initiate or continue to receive pembrolizumab at either 200 mg intravenously (IV) at a frequency of every 3 weeks or 400 mg IV at a frequency of every 6 weeks.
16400882|NCT04620239|Drug|padeliporfin VTP|During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.
16400883|NCT04619225|Device|TetraGraph|FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
16400884|NCT04618315|Device|Hearing Aids|Receiver-in-the-ear hearing aids.
16400885|NCT04602975|Biological|Injection SF2A-TT15 10 µg Adjuvanted|Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
16400886|NCT04602975|Biological|Injection SF2A-TT15 10 µg|Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)
16400887|NCT04602975|Biological|Injection Adjuvanted Placebo|Intramuscular injection of Placebo with alhydrogel
16400888|NCT04602975|Biological|Injection Placebo|Intramuscular injection of the not adjuvanted Placebo
16400889|NCT04602975|Biological|Injection SF2A-TT15 2 µg Adjuvanted|Intramuscular injection of experimental vaccine (adjuvanted 2 µg)
16400890|NCT04602975|Biological|Injection SF2A-TT15 2 µg|Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)
16400891|NCT04602611|Other|Oncology Nurse Navigation|Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse.
16400896|NCT04598087|Behavioral|Prehabilitation|The multi-phasic prehabilitation intervention involves three phases: Phase 1: Before surgery (typically ~25 days); Phase 2: The in-hospital phase (typically 10-14 days); Phase 3: Discharge to 6-weeks after surgery.
16400897|NCT04597164|Other|Artificial liver support system|Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for three times, and comprehensive internal medical treatment. The volume of plasma adsorption in DPMAS is 5000~6000 millilitre. The volume of fresh frozen plasma used in PE is 1000 millilitre.
16400902|NCT04592692|Drug|PEGylated Liposome (PEGLip)|Intravenous co-administration of PEGLip with Simoctocog alfa
16400903|NCT04590547|Drug|GLS-1027|GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
16400904|NCT04590547|Drug|Placebo|Placebo looks like GLS-1027
16400905|NCT04589650|Drug|Alpelisib|Adult participants (group 1) will receive 125 mg of alpelisib oral tablets once daily. Pediatric participants (Group 2: 6 to 17 years old) will receive 50 mg of alpelisib oral tablets once daily. Pediatric participants (Group 3: 2 to 5 years old) will receive alpelisib at dose determined based on the primary analysis for efficacy, safety and PK of alpelisib in Groups 1 and 2.
16400906|NCT04589650|Drug|Placebo|Participants will receive matching placebo once daily up to week 16.
16400907|NCT04583358|Drug|AMT-101 (oral)|AMT 101 is orally administered biological therapeutic taken once daily
16400908|NCT04583358|Other|Placebo (oral)|Orally administered placebo comparator taken once daily
16400909|NCT04582864|Drug|MGD006|MGD006 will be provided by MacroGenics Inc.
16400910|NCT04582864|Procedure|Donor lymphocyte infusion|DLI represents a non-specific form of adoptive cell therapy which involves infusion of a pool of allogeneic immune cells, including CD4+ T cells, CD8+ T cells, regulatory T cells (T Regs), natural killer (NK) cells and professional antigen presenting cells.
16400911|NCT04581369|Other|Care Coordinator Intervention for Direct Intervention Group|"The First Visit: The care coordinator will conduct a visit within 72 hours of hospital discharge to assess the patient's physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These measures will be used to guide the use of care protocols and development of the individualized care plan. The care plan will be developed with an emphasis on coordinating services with the patient's providers.
~The Second Visit: During the second visit, the coordinator will review the individualized care plan with both the patient and the family caregiver and will make revisions to the plan based on assessment outcomes.
~The 6-month Interaction Period: Approximately every 2 weeks, the coordinator will meet with the participant to revisit the care plan and to facilitate care.
~At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians."
16400912|NCT04581369|Other|Care Coordinator Intervention for Standard of Care Group|For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm.
16400913|NCT04581369|Other|Caregiver Intervention|Caregivers of the participants will be assessed for caregiver burden at 3 time points.
16400914|NCT04581200|Behavioral|Lift|The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
16400915|NCT04578093|Behavioral|LARC peer-based curriculum|Peer-based educational videos and supplemental activities
16400916|NCT04572815|Drug|Placebo Administration|Given IV and SC
16400917|NCT04572815|Other|Quality-of-Life Assessment|Ancillary studies
16400918|NCT04572815|Other|Questionnaire Administration|Ancillary studies
16400919|NCT04572815|Biological|Ustekinumab|Given IV and SC
16400921|NCT04568408|Device|Xiaomi MiBand 5|Comparison of sleep-monitoring device against polysomnography (PSG)
16400924|NCT04564742|Drug|Dapagliflozin|Dapagliflozin 10 mg tablets given once daily, per oral use
16400925|NCT04564742|Drug|Placebo|Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use
16400926|NCT04560595|Behavioral|Caffeine Reduction Manual|We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.
16400928|NCT04558294|Drug|Lysergic Acid Diethylamide|A moderate dose of 100 μg LSD will be administered.
16400929|NCT04558294|Drug|Ketanserin Placebo|Mannitol capsules instead of capsules containing Ketanserin.
16400930|NCT04558294|Drug|Ketanserin|A dose of 40 mg Ketanserin will be administered.
16400931|NCT04556656|Drug|Pridopidine|Pridopidine hard gelatin capsule
16400932|NCT04556656|Drug|Placebo|Pridopidine-matching placebo hard gelatin capsule
16400935|NCT04550988|Other|feasibility study|The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device.
16400936|NCT04544189|Drug|Alpelisib|300mg (oral) once daily, in a 28-day cycle
16400937|NCT04544189|Drug|Fulvestrant|Fulvestrant 500 mg (intramuscular, as two 250mg/5 mL injections) on Day 1 and 15 of Cycle 1 and on Day 1 of every Cycle thereafter
16400938|NCT04544189|Drug|Placebo|300 mg by mouth once daily, in a 28-day cycle
16400939|NCT04535609|Drug|REN001|Once daily
16400940|NCT04535609|Drug|Placebo|Once daily
16401079|NCT04310007|Drug|Cabozantinib S-malate|Given PO
16400943|NCT04533438|Device|RhinAer Stylus|The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.
16400944|NCT04533438|Device|Sham|The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
16400945|NCT04532515|Device|Seal-G Surgical Sealant|"Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
~Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis"
16400946|NCT04532515|Device|Seal-G MIST System|"Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
~Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis"
16400947|NCT04530149|Drug|Acetaminophen|receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
16400948|NCT04530149|Drug|Bupivacain|The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
16400949|NCT04530149|Drug|Saline|The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
16400950|NCT04529772|Drug|acalabrutinib|Investigational Product
16400951|NCT04529772|Drug|placebo|Placebo comparator
16400952|NCT04529772|Drug|Prednisone|Investigational Product
16400953|NCT04529772|Drug|Rituximab|Investigational Product
16400954|NCT04529772|Drug|Cyclophosphamide|Investigational Product
16400955|NCT04529772|Drug|Vincristine|Investigational Product
16400956|NCT04529772|Drug|Doxorubicin|Investigational Product
16400957|NCT04528771|Drug|SNO|Six-hour SNO treatment by inhalation at a sequential increasing dose regimen of 20 ppm x 2 hr, 40 ppm x 2 hr, 80 ppm x 2 hr. Patient care and follow-up during and after ENO administration will follow the critical care clinical SOPs developed by our institution (attached in Additional Information), which are consistent with the guidelines set out by the World Health Organization.
16400958|NCT04528771|Drug|Nitrogen gas|Six-hour nitrogen gas treatment by inhalation.Patient care and follow-up during and after ENO administration will follow the critical care clinical SOPs developed by our institution (attached in Additional Information), which are consistent with the guidelines set out by the World Health Organization.
16400959|NCT04528082|Drug|Apremilast|Participants will receive apremilast orally.
16400960|NCT04528082|Drug|Placebo|Participants will receive the matching placebo orally.
16400961|NCT04526938|Device|Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft|Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.
16400962|NCT04524182|Other|control group|"There was no intervention in the control group during study.
~At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise"
16400963|NCT04524182|Other|mobilization group|"Lumbosacral mobilization for 10 minutes in the study group (pelvis forward and backward distraction, passive rotation of the lower body, short lever rotation, long lever rotation, lumbar central posterior-anterior, lumbar unilateral posterior-anterior, anterior rotation-posterior superior iliac spine- down, posterior rotation-posterior superior iliac spine-up were applied.
~At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise"
16400964|NCT04524143|Other|cervical mobilization|"Cervical mobilization techniques were applied in the study. Within the scope of application; rotation with traction, lateral gliding, anterior-posterior gliding with traction, bridging and stroking techniques to the paravertebral muscles were used. Mobilization were performed at grade A (mobilization in painless joint range) and grade B (continuous stretching at the end of the joint range). The mobilization were applied during 10 minutes.
~At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise"
16400965|NCT04524143|Other|control|There was no intervention in the control group during study. At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise
16400968|NCT04511871|Biological|CCT303-406|Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT303-406. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single dose of CCT303-406 via intravenous injection.
16400969|NCT04508049|Device|qMT-MRI to detect fibrosis.|The hypothesis underlying this proposal is that qMT would reliably detect development of renal fibrosis at both 1.5T and 3.0T in subjects with RVD. Patients will be studied with MRI (for fibrosis) and CT (for renal function).
16400970|NCT04507438|Drug|Donepezil 5-10 Mg Oral Tablet|Donepezil 5mg or 10mg oral tablet administered daily for an 8 week period
16400971|NCT04507438|Drug|Placebo Oral Tablet|Placebo oral tablet administered daily for an 8 week period
16400972|NCT04505670|Drug|Donepezil|donepezil orally 5mg
16400973|NCT04505670|Drug|Placebo oral tablet|Placebo
16400974|NCT04505670|Drug|Topical Zinc Oxide|Topical Zinc Oxide 20%
16401080|NCT04310007|Drug|Docetaxel|Given IV
16400975|NCT04504396|Drug|GLP-1 receptor agonist|PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
16400976|NCT04504396|Drug|Placebo|PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
16400977|NCT04504370|Drug|GLP-1 receptor agonist|PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
16400978|NCT04504370|Drug|Placebo|PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
16400979|NCT04501094|Drug|Bintrafusp alfa (M7824)|1200 mg administered IV every two weeks
16400980|NCT04482140|Device|Genta-Foil resorb|Use of Genta-Foil resorb to prevent adhesions in patients undergoing hand surgery
16400981|NCT04474002|Drug|4L Klean Prep®|Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.
16400982|NCT04474002|Drug|1L Klean prep® and 2 sachets Picoprep®|Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.
16400983|NCT04472260|Procedure|Verticalization and Prone position|"The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
~The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours."
16400984|NCT04471844|Device|Optune®|"Optune® is a commercial, portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division.
~In treatment arm I, the patient starts Optune® concurrently with RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.
~In treatment arm II, the patient starts RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.
~The study treatment plan will continue for 24 months, if no tumor progression."
16400985|NCT04456296|Drug|Aveed Injectable Product, Fortesta or Testim|Depending on the treatment arm, the daily dose of the study drug will be either a fixed dosage or titrated for each subject, according to approved dosage and administration instructions, if necessary, until the circulating testosterone concentrations of the subject reaches normal concentrations (300-1000 ng/dL).
16400989|NCT04448314|Diagnostic Test|PointCheck|This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
16400990|NCT04440033|Other|Baseline assessment of demographic, anthropometric and clinical characteristics|"Age
~Sex
~Height
~Body weight
~Handedness
~Medication use
~Blood pressure
~Global cognition (Montreal Cognitive Assessment)
~Fear of falling (Shortened Iconographical Falls Efficacy Scale)
~History of falls (number of falls in the past month)
~Time since diagnosis and symptom onset
~Disease severity (UPDRS part III, Hoehn and Yahr)
~Non-motor symptoms (UPDRS part I)
~Motor symptoms (UPDRS part III)
~Motor complications (UPDRS part IV)
~Disease-dominant side (UPDRS part III)
~Freezing of gait (New Freezing of Gait Questionnaire)"
16400991|NCT04440033|Other|Baseline assessment of demographic, anthropometric and clinical characteristics|"Age
~Sex
~Height
~Body weight
~Handedness
~Medication use
~Blood pressure
~Global cognition (Montreal Cognitive Assessment)
~Fear of falling (Shortened Iconographical Falls Efficacy Scale)
~History of falls (number of falls in the past month)"
16400992|NCT04440033|Other|Locomotor assessments|"First, 9 anthropometric measurements will be taken, 39 reflective markers will be placed, and a 6-min practice walking session will be conducted to familiarize participants with self-paced treadmill walking (SPTW). Thereafter, participants will partake in 7 experimental conditions in a (semi-)randomized order:
~3 min standing
~3 min standing while answering semi-standardized questions
~3 min SPTW
~3 min SPTW while answering semi-standardized questions (SPTW-Q)
~3 min SPTW while verbally describing a VR environment (SPTW-VR1)
~6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)"
16400993|NCT04440033|Other|Speech assessments|"Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)).
~Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen
~The Speech Handicap Index (a 15-item self-reported questionnaire)"
16400994|NCT04440033|Other|Audiology assessments|"Otoscopy
~Tympanometry
~Pure tone audiometry
~Otoacoustic emissions
~Video Head Impuls Test
~Cervical Vestibular Evoked Myogenic Potentials
~Ocular Vestibular Evoked Myogenic Potentials
~Oculomotor function testing
~Positional testing
~Static visual acuity test
~Dynamic visual acuity test
~Dizziness Handicap Inventory (a 25-item self-assessment inventory)"
16400995|NCT04435626|Drug|Finerenone (BAY94-8862)|"For participants with an eGFR ≤60 mL/min/1.73 m^2: Starting dose is 10 mg OD and maximum dose 20 mg OD.
~For participants with an eGFR >60 mL/min/1.73 m^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets."
16400996|NCT04435626|Other|Placebo|Placebo tablets matching BAY94-8862 are administered orally.
16400997|NCT04434040|Drug|Atezolizumab|Atezolizumab is a type of antibody and is administered intravenously.
16400998|NCT04434040|Drug|Sacituzumab govitecan|Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously
16401081|NCT04310007|Drug|Gemcitabine Hydrochloride|Given PO
16401082|NCT04310007|Drug|Nab-paclitaxel|Given IV
16400999|NCT04426929|Other|Conventional exercise therapy|Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.
16401000|NCT04426929|Other|Closed Chain Exercise Group|An exercise program consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain exercises and proprioceptive exercises will be implemented in this group.
16401001|NCT04426929|Other|Video Based Exercise Group|Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.
16401002|NCT04424914|Diagnostic Test|Scintigraphy|scintigraphy
16401003|NCT04424199|Behavioral|Rightward Attentional Shift (R-PA)|Patients will perform a session of 90 pointing movements toward a visual target presented on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward attentional shift.
16401004|NCT04424199|Behavioral|Leftward Attentional Shift (L-PA)|Patients will perform a session of 90 pointing movements toward a visual target presented on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a leftward attentional shift.
16401005|NCT04422470|Other|Non-interventional study|Non-interventional study
16401006|NCT04421053|Behavioral|prenatal care for women with GDM|we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.
16401007|NCT04420572|Drug|ozone injection|ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.
16401008|NCT04420572|Drug|betamethasone|1ml betamethasone will be used for steroid injection.
16401009|NCT04417660|Drug|M7824|Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events.
16401010|NCT04414449|Other|ICT-enabled Social-emotional Learning|ICT-enabled Social-emotional Learning
16401012|NCT04408430|Device|Transseptal ViMAC|Transseptal TMVR using balloon-expandable aortic transcatheter valves.
16401013|NCT04405063|Device|Paclitaxel Coated PTCA Balloon Catheter|Drug coated balloon
16401014|NCT04402788|Drug|Atezolizumab|Given IV
16401015|NCT04402788|Radiation|Radiation Therapy|Undergo radiation therapy
16401016|NCT04400305|Behavioral|Digital Health Online Platform|"The website has 10 lessons that the participant will gain access to on a bi-weekly basis. Lesson titles are as follows:
~Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity"
16401017|NCT04394117|Drug|Angiotensin Receptor Blockers|"Angiotensin Receptor Blockers class have been in clinical use for more than 30 years for their cardiac and renal protective effects. ARBs mechanism of action is through selective inhibition of angiotensin II by competitive antagonism of the angiotensin receptor. ARBs displace angiotensin II from the angiotensin I receptor and produce their protective effects by reducing the downstream effects of angiotensin II-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic response.
~The virus causing COVID-19, the SARS-CoV-2 virus binds to the extracellular portion of ACE2 expressed on type II alveolar cells in the lungs which is followed by internalization of ACE2 before downregulating membrane ACE2 expression. Both these components appear to require angiotensin receptor Type 1 (AT1R), and ARBs, which block the actions of AT1R, would reduce the severity of COVID-19 and reduce the duration of symptoms."
16401018|NCT04394117|Other|Placebo|Placebo
16401033|NCT04377932|Genetic|AGAR T cells|"Four different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. The following dose levels will be evaluated:
~DL1: 3x10^7/m2 DL2: 1x10^8/m2 DL3: 3x10^8/m2 DL4: 1x10^9/m2
~The doses are calculated according to the actual number of GPC3-CAR transduced T cells."
16401034|NCT04377932|Drug|Cytoxan|Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously.
16401035|NCT04377932|Drug|Fludara|Fludarabine will be given at a dose of 30 mg/m2/day for 3 days given intravenously.
16401037|NCT04371666|Drug|Pamrevlumab|pamrevlumab 35 mg/kg IV Q2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally
16401038|NCT04371666|Drug|Placebo|matching placebo IV Q2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally
16401044|NCT04362566|Drug|Bupivacaine|Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
16401045|NCT04362566|Other|Placebo Saline|Scalp flap: 2.5cc salinefor 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to saline used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
16401046|NCT04354649|Drug|Hydroxychloroquine|Hydroxychloroquine 5mg/kg PO daily
16401047|NCT04354649|Other|Placebo|Hydroxychloroquine-matching placebo
16401048|NCT04352140|Device|Tetragraph|FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
16401049|NCT04352127|Device|TetraGraph|FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
16401050|NCT04348864|Diagnostic Test|COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support|An immunodiagnostic rapid (5-20 minute) test detects circulating antibodies in the blood, serum or plasma of individuals who have been infected with the novel coronavirus SARS-COV-2 as detected by rapid antigen test or LAMP/PCR-based molecular test taken from nasopharyngeal swab samples in the recent past.
16401051|NCT04348864|Other|Telemedicine|Imaging of the test using the software application COVIDscanDX and upload to server by the subject and phone, video or messaging consult with a clinician for interpretation and instructions establishes the telemedicine (i.e. virtual point-of-care).
16401052|NCT04347954|Drug|Povidone-Iodine 2%|Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day
16401053|NCT04347954|Drug|Povidone-Iodine 0.5%|Two sprays to each nare of PVP-I 0.5% via nasal spray bottle, four times a day
16401054|NCT04347954|Drug|Isotonic saline 0.9%|Two sprays to each nare of isotonic saline (0.9% NaCl) via nasal spray bottle, four times a day
16401055|NCT04343287|Drug|BRM421|The active control with BRM421 solution
16401056|NCT04343287|Drug|Placebo|The vehicle solution
16401058|NCT04335084|Drug|Hydroxychloroquine|Prophylaxis treatment for COVID-19
16401059|NCT04335084|Dietary Supplement|Vitamin C|Prophylaxis treatment for COVID-19
16401060|NCT04335084|Dietary Supplement|Vitamin D|Prophylaxis treatment for COVID-19
16401061|NCT04335084|Dietary Supplement|Zinc|Prophylaxis treatment for COVID-19
16401062|NCT04334057|Drug|Turoctocog alfa pegol|Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
16401063|NCT04321031|Drug|Placebo|Tablet
16401064|NCT04321031|Drug|PF-06865571|Tablet
16401065|NCT04321031|Drug|PF-05221304|Tablet
16401066|NCT04317313|Other|FDG PET radiomic feature evaluation|"A total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features.
~In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature."
16401067|NCT04316871|Drug|1.5 mg of Morphine Sulfate|1.5 mg of Morphine Sulphate will be given epidurally.
16401068|NCT04316871|Drug|Normal saline|Normal saline will be given epidurally.
16401069|NCT04316871|Drug|3 mg of Morphine Sulfate|3 mg of Morphine Sulphate will be given epidurally.
16401070|NCT04316871|Drug|4.5 mg of Morphine Sulfate|4.5 mg of Morphine Sulphate will be given epidurally.
16401074|NCT04315233|Drug|Ribociclib|Ribociclib Dose Level 0 (starting dose) 200mg QD Dose Level 1A 400mg on Days 8-28 Dose Level 1B 200mg QD Dose Level 2 400mg on Days 8-28
16401075|NCT04315233|Drug|Belinostat|Belinostat Dose Level 0 (starting dose) 600mg/m2 on Days 1-5 Dose Level 1A 600mg/m2 on Days 1-5 Dose Level 1B 1000mg/m2 on Days 1-5 Dose Level 2 1000mg/m2 on Days 1-5
16401076|NCT04312256|Device|TetraGraph|FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin (ECG) electrodes.
16401077|NCT04310423|Drug|Placebo|Matched to endotoxin
16401078|NCT04310423|Biological|Endotoxin|Bolus dose of 0.8 ng/kg
16401086|NCT04305470|Drug|Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)|One time oral dose on day of surgery (20 mg/kg bodyweight)
16401087|NCT04305054|Biological|Pembrolizumab|Administered via IV infusion at a specified dose on specified days
16401088|NCT04305054|Biological|Vibostolimab|Administered via IV infusion at a specified dose on specified days
16401089|NCT04305054|Biological|Pembrolizumab/Quavonlimab|Administered via IV infusion at a specified dose on specified days
16401090|NCT04305054|Drug|Lenvatinib|Administered via oral capsule at a specified dose on specified days
16401091|NCT04305041|Biological|Pembrolizumab|Administered via IV infusion at a specified dose on specified days
16401092|NCT04305041|Biological|Quavonlimab|Administered via IV infusion at a specified dose on specified days
16401093|NCT04305041|Biological|Vibostolimab|Administered via IV infusion at a specified dose on specified days
16401094|NCT04305041|Drug|Lenvatinib|Administered via oral capsules at a specified dose on specified days
16401095|NCT04303169|Biological|Pembrolizumab|Administered via IV infusion at a specified dose on specified days
16401096|NCT04303169|Biological|Vibostolimab|Administered via IV infusion at a specified dose on specified days
16401097|NCT04303169|Biological|V937|Administered via IT injection at a specified dose on specified days
16401098|NCT04302961|Other|Auditory Feedback|Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.
16401099|NCT04302961|Other|No Feedback|Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.
16401100|NCT04297683|Drug|Zilucoplan|"Drug: Zilucoplan
~Administration: Subcutaneous injection
~Dose: Minimum of .0.22 mg/kg daily to a maximum dose of 0.42 mg/kg daily, dependent on weight"
16401101|NCT04297683|Drug|Verdiperstat|"Drug: Verdiperstat
~Administration: Oral
~Dose: 600mg twice daily"
16401102|NCT04297683|Drug|CNM-Au8|"Drug: CNM-Au8
~Administration: Oral
~Dose: 30 mg or 60 mg daily"
16401103|NCT04297683|Drug|Pridopidine|"Drug: Pridopidine
~Administration: Oral
~Dose: 45mg twice daily"
16401104|NCT04295941|Drug|TraZODone Hydrochloride 300 MG|Oral administration of Trazodone once-a-day.
16401105|NCT04292405|Device|Wearable Cardioverter Defibrillator|Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.
16401106|NCT04276558|Drug|Udonitrectag|Eye drop solution in single dose unit.
16401107|NCT04276558|Other|Vehicle|Eye drop solution with no active substance in single dose unit.
16401108|NCT04276233|Drug|Prednisone/ Prednisolone|Prednisone/prednisolone will be available as 5 mg tablet to be administered via oral route as per prescribed titration regimen.
16401109|NCT04276233|Biological|Mepolizumab|Mepolizumab will be available as a lyophilized cake in sterile vials and will be reconstituted with sterile water for injection, just prior to use.
16401110|NCT04276233|Drug|Salbutamol|Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
16401111|NCT04269161|Device|Automatic control of inspired oxygen|A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
16401121|NCT04267562|Device|Minitouch System|The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
16401122|NCT04265950|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
16401123|NCT04265261|Drug|Placebo|Participants will receive oral placebo matched to RG7774
16401124|NCT04265261|Drug|RG7774|Participants will receive oral RG7774
16401125|NCT04264390|Behavioral|Movement-to-music|Movement-to-music is a physical activity program that was developed onsite at a state-of-the-art adapted fitness facility. The program includes movements that are coupled with music to enhance muscular strength, cardiorespiratory capacity, flexibility, and balance. For this study, the program will be packaged into playlists of exercise videos that will be given to participants. Participants will be instructed to complete the prescribed videos 3 times per week. Participants will also be asked to attend 4 behavioral coaching calls with a telecoach. The goals of the behavioral coaching calls will be to address issues with the technology components of the program and promote physical activity participation within the community and adherence to the movement-to-music videos.
16401126|NCT04260191|Drug|AMG 910|Dose Exploration Dose Expansion
16401129|NCT04251949|Procedure|LED photobiomodulation|1 PLED session before each radiotherapy session, until the end of the radio or radio-chemotherapy treatment. Each session will last 7 minutes. The light delivered will be preset on the lamp which will deliver a red light of a wavelength of 630nm, at a fluence of 37J/cm².
16401130|NCT04251533|Drug|alpelisib|300 mg orally once per day (QD)
16401131|NCT04251533|Drug|placebo|300 mg orally once per day (QD)
16401132|NCT04251533|Drug|nab-paclitaxel|100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle
16401133|NCT04246177|Drug|Lenvatinib|Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) via oral capsules once a day during each 21-day cycle.
16401134|NCT04246177|Biological|Pembrolizumab|Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
16401135|NCT04246177|Drug|Oral Placebo|Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
16401136|NCT04246177|Drug|IV Placebo|Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
16401137|NCT04246177|Procedure|TACE|Conducted as a background procedure of chemotherapeutic and embolic agent(s).
16401138|NCT04246086|Drug|Glofitamab|Participants will receive intravenous (IV) CD20-TCB as defined by the study protocol
16401139|NCT04246086|Drug|Mosunetuzumab (IV)|Participants will receive IV mosunetuzumab as defined by the study protocol
16401140|NCT04246086|Drug|Obinutuzumab|Participants will receive IV obinutuzumab as defined by the study protocol
16401141|NCT04246086|Drug|Tocilizumab|Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
16401142|NCT04246086|Drug|Lenalidomide|Participants will receive oral lenalidomide as defined by the study protocol
16401143|NCT04246086|Drug|Mosunetuzumab (SC)|Participants will receive SC mosunetuzumab as defined by the study protocol
16401144|NCT04240288|Other|Procalcitonin-guided antibiotic treatment|Antibiotics will be administered based on the procalcitonin lab results.
16401145|NCT04240288|Other|Standard of Care Antibiotic Treatment|Antibiotics will be administered based on standard of care treatment. The treating physicians will determine the treatment course.
16401146|NCT04235777|Drug|M7824|1200 mg administered IV every two weeks while on M9241 and with or without SBRT
16401147|NCT04235777|Drug|M9241|An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT
16401148|NCT04235777|Radiation|Stereotactic body radiation therapy (SBRT)|A fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and M9241
16401149|NCT04235608|Drug|Inhaled sedation with sevoflurane|Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden).
16401150|NCT04235608|Drug|intravenous sedation with propofol|intravenous sedation with propofol, as already routinely used in participating ICUs.
16401151|NCT04234061|Combination Product|ibrutinib and Tisagenlecleucel|Single-arm study investigating combination of ibrutinib and Tisagenlecleucel treatment
16401152|NCT04233034|Device|HCL|Hybrid Closed Loop therapy
16401153|NCT04233034|Drug|verapamil 120mg tablet|verapamil tablet
16401154|NCT04233034|Device|non-HCL|Usual diabetes care
16401155|NCT04233034|Drug|placebo|placebo pill manufactured to mimic verapamil 120mg tablet
16401161|NCT04209855|Drug|Mirvetuximab Soravtansine|Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
16401162|NCT04209855|Drug|Paclitaxel|Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer.
16401163|NCT04209855|Drug|Topotecan|Topotecan induces irreversible DNA damage. It inhibits topoisomerase 1, leading to both single and double strand DNA break that eventually promote apoptosis. Topotecan was approved for treatment of epithelial ovarian cancer after failure of initial or subsequent chemotherapy.
16401164|NCT04209855|Drug|Pegylated liposomal doxorubicin|Pegylated liposomal doxorubicin is a standard chemotherapy regimen used for treating platinum-resistant ovarian cancer. The active component doxorubicin is an anthracycline that intercalates DNA, leading to inhibition of replication and subsequently, the inhibition of proper cell division.
16401165|NCT04205175|Drug|Feiba|This is a single center, open label, dose escalation study of in vivo administration of Feiba in congenital hemophilia A patients with inhibitors who are on emicizumab.
16401169|NCT04200482|Behavioral|One Diet and Physical Activity Session|Attend 1 remote diet and physical activity session
16401170|NCT04200482|Other|Electronic (e) Health (eHealth) Communication Intervention|Receive eHealth communication intervention
16401171|NCT04200482|Behavioral|Twelve Diet and Physical Activity Group Sessions|Attend 12 remote diet and physical activity sessions in 6 months
16401172|NCT04200482|Other|Questionnaire Administration|Ancillary studies
16401173|NCT04200482|Other|Quality-of-Life Assessment|Ancillary studies
16401177|NCT04198012|Device|HemoCare™ Hemodialysis System|The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.
16401219|NCT04141774|Other|Magnetic Resonance Imaging|A functional magnetic resonance image will be collected.
16401220|NCT04141774|Other|EEG|EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
16401178|NCT04187027|Device|pulsed electromagnetic field therapy device|magnetic field stimulation (MFS) is a novel technique for stimulating the nervous system non-invasively, which can activate deep neural structures via induced electric currents, without pain and discomfort. Also, several clinical trials including placebo-controlled studies have shown that MFS of the pelvic floor and sacral roots is effective for overactive bladder (OAB). MFS induces inhibitory effects on detrusor overactivity in a similar manner to electrical stimulation, with significant clinical advantages. MFS of the sacral nerve roots could be a promising alternative treatment for OAB.
16401179|NCT04185883|Drug|Sotorasib|Sotorasib administered orally as a tablet.
16401180|NCT04185883|Drug|AMG 404|AMG 404 administered as an intravenous (IV) infusion.
16401181|NCT04185883|Drug|trametinib|trametinib administered orally as a tablet.
16401182|NCT04185883|Drug|RMC-4630|RMC-4630 administered orally as a capsule.
16401183|NCT04185883|Drug|afatinib|afatinib administered orally as a tablet.
16401184|NCT04185883|Drug|pembrolizumab|pembrolizumab administered as an intravenous (IV) infusion.
16401185|NCT04185883|Drug|panitumumab|panitumumab administered as an intravenous (IV) infusion.
16401186|NCT04185883|Drug|carboplatin, pemetrexed, docetaxel|carboplatin, pemetrexed, docetaxel administered as an intravenous (IV) infusion.
16401187|NCT04185883|Drug|atezolizumab|atezolizumab administered as an intravenous (IV) injection.
16401188|NCT04185883|Drug|everolimus|everolimus administered orally.
16401189|NCT04185883|Drug|palbociclib|palbociclib administered orally as a tablet.
16401190|NCT04185883|Drug|MVASI® (bevacizumab-awwb)|MVASI® (bevacizumab-awwb) administered as an intravenous (IV) infusion.
16401191|NCT04185883|Drug|TNO155|TNO155 administered orally as a capsule.
16401192|NCT04185883|Drug|FOLFIRI|FOLFIRI chemotherapy combination of leucovorin administered as an intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
16401193|NCT04185883|Drug|FOLFOX|FOLFOX chemotherapy combination of leucovorin administered as intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.
16401194|NCT04185883|Drug|Loperamide|Loperamide administered orally as a capsule.
16401195|NCT04178824|Behavioral|Discount Intervention|15% or 30% discount on fruits and vegetables
16401196|NCT04178434|Behavioral|Internet-based CBT intervention|A nine step intervention including internet-based feedback by psychologists
16401197|NCT04175912|Drug|Carboplatin|Given IV
16401198|NCT04175912|Drug|Paclitaxel|Given IV
16401199|NCT04175912|Drug|Pevonedistat|Given IV
16401200|NCT04171960|Other|Blood Draw Within 12 Hours of Injury|- Specimens collected for i-STAT testing and, if applicable, for optional collection of DNA for possible future genetic testing.
16401201|NCT04171960|Other|3T MRI|- 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months following injury.
16401202|NCT04171960|Other|In-Person Outcome Assessment at Baseline|-3 Outcome Assessments administered at Baseline.
16401203|NCT04171960|Other|In-Person Outcome Assessment at Follow-Up|- Full set of Outcome Assessment at 2 weeks, 6 weeks, and 6 months following injury.
16401204|NCT04171960|Other|Phone Outcome Assessment|- 6 Outcome Assessments administered at 3 months following injury by Phone.
16401205|NCT04171960|Other|Blood Draw After 12 Hours of Injury|- Specimens collected at 12-24 hours, 2 weeks, and 6 month following injury then processed for storage for future use.
16401206|NCT04171765|Drug|Placebo|Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
16401207|NCT04171765|Drug|BFKB8488A|Participants will receive subcutaneous (SC) BFKB8488A.
16401208|NCT04166929|Biological|Haplo SCT with NK cells|Patients in this arm receive haplo-SCT followed by one boost of NK cells one/two weeks after the transplant. Lymphocyte are collected by apheresis from the donor one-two weeks after BM harvest. CD3 negative/CD56 positive cells are selected by immunomagnetic columns (other lymphocytes are stored to be used as DLI)
16401209|NCT04166929|Biological|Haplo SCT|Patients in this arm receive a standard haplo-SCT. All administerd therapies are the same as in other arm, except for the NK cell boost..
16401210|NCT04166019|Behavioral|Peer-led self-management program|The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being.
16401211|NCT04166019|Behavioral|Psycho-education group|The psycho-education group program is comprised of six components: introduction and goal-setting; basic understanding of psychosis and symptom and emotion self-care; education workshop of psychosis care, treatment and community support services; learning about self-care skills; establishing social support and effective coping skills; and skills practices, review and future plan.
16401212|NCT04166019|Behavioral|Usual care|Routine care services consist of monthly psychiatric consultation and treatments prescribed by psychiatrist, nursing advice on community care, brief education (1-2 hourly sessions) about mental illness/treatments by psychiatric nurses, home visits by case managers, and/or referrals to community/welfare services.
16401213|NCT04150419|Other|Group 1|Attentional training to avoid threatening, negative or pain-related information.
16401214|NCT04150419|Other|Group 2|Attention training for vigilance for positive emotional information.
16401215|NCT04150419|Other|Group 3 (control group)|Neutral attentional training (control group).
16401216|NCT04147884|Device|Millipede Transcatheter Annuloplasty Ring System (Millipede System)|The Millipede Transcatheter Annuloplasty Ring System is a repair device used for treating mitral valve regurgitation (MR). The system consists of several components: a transcatheter annuloplasty ring (implant) which remains in the body and a delivery system and intracardiac echocardiography catheter (imaging device) used to deliver the implant to the mitral valve.
16401217|NCT04141774|Device|Functional Electric Stimulation (FES)|FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
16401218|NCT04141774|Behavioral|Behavioral Assessments|These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
16401221|NCT04136353|Drug|Darolutamide|2 x 300mg oral tablets twice daily for 96 weeks
16401222|NCT04136353|Drug|Placebo oral tablet|2 oral tablets twice daily for 96 weeks
16401223|NCT04136353|Drug|Luteinizing Hormone-Releasing Hormone Analog|All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.
16401224|NCT04136353|Radiation|External Beam Radiotherapy|All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.
16401225|NCT04124120|Procedure|Procedure: Single arterial graft|"This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
~Coronary artery bypass surgery, also known as coronary artery bypass graft (open chest surgery). During CABG disease vein will be replaced through the by"
16401226|NCT04124120|Procedure|Procedure: Multiple arterial grafting|This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
16401227|NCT04122196|Drug|Pregabalin 300mg|Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
16401228|NCT04122196|Drug|Placebo oral tablet|Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
16401229|NCT04117958|Drug|AMG 199|AMG 199 is a BiTE® molecule designed to direct T cells towards MUC17-expressing cells.
16401230|NCT04115098|Drug|Drug order 1|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401231|NCT04115098|Drug|Drug order 2|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401232|NCT04115098|Drug|Drug order 3|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401233|NCT04115098|Drug|Drug order 4|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401234|NCT04115098|Drug|Drug order 5|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401235|NCT04115098|Drug|Drug order 6|each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
16401238|NCT04097340|Device|Attentional Bias Retraining (ABR)|Participants randomized to this intervention will receive 2 weeks of ABR for opioids delivered via a mobile device.
16401239|NCT04097340|Device|Control Training|Participants randomized to this intervention will receive 2 weeks of training without ABR, delivered via a mobile device.
16401240|NCT04094506|Drug|ASP1948|Intravenous
16401247|NCT04089969|Diagnostic Test|CTA/FFRct|Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.
16401248|NCT04089969|Diagnostic Test|SOC cardiovascular evaluation|Standard of care (SOC) cardiovascular evaluation i.e ECG, 2 D echocardiogram and pharmacologic stress test such as Dobutamine and Myocardial Perfusion Imaging stress test.
16401249|NCT04088799|Other|No intervention|No intervention
16401254|NCT04085146|Procedure|Individualized optimal positive end-expiratory pressure|Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA).
16401255|NCT04085146|Procedure|Conventional positive end-expiratory pressure|A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
16401257|NCT04079673|Procedure|Patient controlled epidural analgesia|Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control
16401258|NCT04079673|Drug|Intravenous patient controlled analgesia|Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control
16401259|NCT04076761|Drug|Trifluridine/Tipiracil|FTD/TPI is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. Trifluridine is the active cytotoxic component of FTD/TPI; its triphosphate form is incorporated into DNA, with such incorporation appearing to result in its anti- tumor effects. Tipiracil hydrochloride is a potent inhibitor of thymidine phosphorylase and, when combined with trifluridine to form FTD/TPI, prevents the rapid degradation of the trifluridine, allowing for the maintenance of adequate plasma levels of the active drug.
16401260|NCT04071782|Device|Drug Coated Balloon|SELUTION DCB will be used during lower limb angioplasty for treatment of lesions that are TASC C and D, in patients with Critical Limb Ischemia
16401261|NCT04069520|Other|aNMT Biofeedback|"aNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine realtime transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create (animate) a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention. The aNMT biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 12-week, pre-season training program occurring over 6 weeks."
16401262|NCT04069520|Other|Sham Biofeedback|Sham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases. The sham biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 12-week, pre-season training program occurring over 6 weeks.
16401263|NCT04065386|Device|Active taVNS|Patients will receive transcutaneous auricular vagal nerve stimulation (taVNS), at the cymba conchae, bilaterally, during 45 minutes (alternating 30 s on and 30 s off periods). Current intensity: 3 mA or less according to the participant's pain threshold, width: 200-300 μsec.
16401264|NCT04065386|Device|sham taVNS|Patients will receive transcutaneous auricular vagal nerve stimulation (taVNS), at the ear lobe, bilaterally, during 45 minutes (alternating 30 s on and 30 s off periods). Current intensity: 3 mA or less according to the participant's pain threshold, width: 200-300 μsec.
16401265|NCT04059640|Device|LiquiBand FIX8 Open Hernia Mesh Fixation Device|"Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.
~Subjects will be evaluated intra-operatively, post-operatively, at discharge, and at 12 months post-operatively. The Liquiband surgical study device is considered a permanent implant."
16401269|NCT04053673|Drug|RBN-2397|an oral PARP7 Inhibitor
16401270|NCT04049500|Other|Digital Diabetes Prevention Program (dDPP)|dDPP tool suite to integrate with the EHR and clinical workflows
16401271|NCT04049175|Drug|Treatment A|Tablet of CHF 6532
16401272|NCT04049175|Drug|Treatment B|Tablet of CHF 6532
16401273|NCT04049175|Drug|Treatment C|Tablet of CHF 6532
16401274|NCT04049175|Drug|Treatment D|Tablet of CHF 6532 placebo
16401275|NCT04034576|Behavioral|Cognitive behavior therapy of trainee therapists|In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 24 sessions, while on average every fourth is supervized by an CBT expert therapist.
16401276|NCT04022980|Drug|Nivolumab|HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.
16401277|NCT03985267|Behavioral|Mindfulness based Swinging Effect Intervention|Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.
16401278|NCT03983850|Drug|Busulfan|Busulfan should be administered intravenously via a central venous catheter as a three hour infusion every 24 hours.
16401279|NCT03983850|Drug|Fludarabine|Fludarabine will be infused by IV over 60 minutes.
16401674|NCT02968602|Other|Placebo|Placebo capsules taken twice daily for two weeks.
16401280|NCT03983850|Drug|Cyclophosphamide|IV cyclophosphamide will be administered over 2 hours. Slower rates of infusion may be used to decrease side effects. A fluid intake of greater than 2 L/day is recommended during and for 1 to 2 days after cyclophosphamide administration.
16401281|NCT03983850|Drug|Mycophenolate Mofetil|Any oral formulation should be taken on an empty stomach, 1 hour before or at least 2 hours after meals. Oral formulations should not be administered simultaneously with antacids. Avoid inhalation or direct contact with skin or mucous membranes of dry powder contained in capsules or suspension. IV solutions should be administered over at least two hours through either a peripheral or central vein and should not be administered by rapid or bolus injection.
16401282|NCT03983850|Drug|Sirolimus|Oral tablets should be administered approximately 4 hours after cyclosporine administration. Sirolimus is administered orally, once daily, without food. Patients unable to tolerate tablets may take the oral solution formulation.
16401283|NCT03976895|Procedure|Supine position (SP)|"Infants under high flow nasal cannula (HFNC) will be positioned in the supine position.
~Patients may be positioned temporarily in lateral position between periods of supine position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis."
16401284|NCT03976895|Procedure|Prone position (PP)|"Infants under high flow nasal cannula (HFNC) will be placed in the prone position during at least 24 hours over the first 48 hours. The positioning will be standardized (chest on the bed plan and abdomen cleared) and children should be placed in the prone position immediately after randomization.
~Patients may be positioned temporarily in lateral position between periods of prone position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis."
16401285|NCT03975179|Procedure|Omission of intraoperative frozen section biopsy for margin status|Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
16401286|NCT03975179|Procedure|Frozen section biopsy for margin status|Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
16401287|NCT03970538|Device|LimFlow System|Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
16401288|NCT03961581|Behavioral|Using electric car|Child will use little electric cars to go to the reception of operating theatre to operating room.
16401289|NCT03960060|Biological|CCT301-59|Collect blood from the patients and isolate peripheral blood mononuclear cells for the production of CCT301-59. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion during the production of CCT301-59 and then subjects will receive one dose of CCT301-59 via intravenous injection.
16401290|NCT03959605|Genetic|blood sample for genetic test|detection of pathogenic variants among the 19 genes known to be involved in albinism
16401291|NCT03959605|Diagnostic Test|Ophtalmological examination|measurement of visual acuity, OCT and OCTA
16401292|NCT03955835|Device|Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.|Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.
16401293|NCT03949036|Other|Crystalloid fluid administration with the target of stroke volume variation ≤ 12%|The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%
16401294|NCT03949036|Other|Crystalloid fluid administration with the target of stroke volume variation ≤ 6%|The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%
16401295|NCT03945981|Drug|Dolutegravir + Lamivudine FDC|Dolutegravir + Lamivudine FDC is available as white oval film-coated tablets which are packed in high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets
16401296|NCT03944902|Drug|Cohort 1: Dose Escalation|The first 3 participants will be enrolled on a fixed dose of Niraparib and CB-839, 600mg. Participants will be evaluated for DLT's, if there are none, they will be enrolled in the next cohort.
16401297|NCT03944902|Drug|Cohort 2: Dose Escalation|If no dose limiting toxicities, 3 additional participants will be enrolled in this cohort. Participants will receive a fixed dose of Niraparib and CB-839, 800mg.
16401298|NCT03941704|Dietary Supplement|Pulse-based diet|Low Glycemic Index
16401299|NCT03941704|Dietary Supplement|Regular diet|Moderate Glycemic Index
16401300|NCT03938103|Behavioral|Enhanced Go NAPSACC|In the Enhanced delivery model, TA coaches will help centers create an implementation team and conduct a needs assessment to identify organizational strengths and challenges. TA coaches will also provide an orientation to Go NAPSACC and its online tools and help the team develop a plan to guide their Go NAPSACC efforts. The team will then work through 2 cycles of Go NAPSACC over 12 months. During each cycle (6 months), centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. Throughout this 12-month period, TA coaches will provide monthly check-ins incorporating tailored support based on the results from the needs assessment. They will also organize 2-3 meetings among teams from different centers to reflect and share lessons learned.
16401301|NCT03938103|Behavioral|Basic Go NAPSACC|In the Basic delivery model, TA coaches will provide an orientation to Go NAPSACC and its online tools to the center director. The director will then work 2 cycles of Go NAPSACC over 12 months. During each cycle (6 months), centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. Throughout this 12-month period, TA coaches will provide monthly brief check-ins.
16401302|NCT03936478|Radiation|MRIdian Radiation Treatment Unit|partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin
16401303|NCT03922308|Other|Placebo|Participants will receive injection of placebo matched to SHP655.
16401304|NCT03922308|Drug|SHP655|Participants will receive injection of SHP655.
16401305|NCT03922308|Other|Standard of Care|Participants will receive PEX as Standard of Care (SOC).
16401510|NCT03555149|Drug|Isatuximab|Isatuximab will be administered on Day 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. Cycles will be 21 days long.
16401308|NCT03919799|Drug|Belumosudil (KD025)|ROCK-2 Inhibitor
16401309|NCT03919799|Drug|Placebo|Inactive substance
16401310|NCT03917381|Biological|GEN1046|GEN1046 will be administered intravenously once every 21 days (in selected expansion cohorts GEN1046 will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles)
16401311|NCT03917381|Biological|GEN1046 in combination with docetaxel (in a single expansion cohort)|GEN1046 and docetaxel will be administered intravenously once every 21 days.
16401312|NCT03914794|Drug|Pemigatinib|Participants will take Pemigatinib once daily on days 1 through 28 of each cycle prior to standard of care TURBT.
16401339|NCT03911505|Biological|Cipaglucosidase Alfa|Enzyme Replacement Therapy via intravenous infusion
16401340|NCT03911505|Drug|Miglustat|Participants received Cipaglucosidase Alfa (ATB200) co-administered with Miglustat(AT2221)
16401351|NCT03897088|Drug|PART 1: Double-blind Placebo-controlled|all eligible subjects will receive either tildrakizumab or placebo
16401352|NCT03897088|Drug|PART 2: Double-blind Active Treatment Extension|subjects initially on placebo will be switched over to receive tildrakizumab while subjects initially on tildrakizumab will continue to receive tildrakizumab as per defined schedule
16401358|NCT03888066|Drug|Patiromer|The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
16401359|NCT03888066|Drug|Placebos|The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
16401360|NCT03887988|Procedure|"Primary early reconstruction"|Primary surgical reconstruction of the fracture within 3 weeks after injury
16401361|NCT03887988|Other|Nonsurgical|Nonsurgical treatment of fracture
16401362|NCT03887988|Procedure|"Primary delayed reconstruction"|Primary surgical reconstruction of the fracture more than 3 weeks after injury
16401363|NCT03887988|Procedure|Secondary reconstruction|Second surgical reconstruction of the fracture after a primary reconstruction.
16401364|NCT03887741|Biological|Plasmapheresis|Patient will have monthly plasma exchange with young ApoE 33 plasma. Each exchange will be 1.5 volume of patient's plasma
16401365|NCT03887741|Biological|Plasma infusion|Infuse every two weeks with ApoE33 young plasma (1unit) for 6 months
16401366|NCT03877133|Device|Near-infrared spectroscopy|Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.
16401367|NCT03875651|Device|SYNERGY 4.50 mm and 5.0 mm Coronary Stent System|The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
16401371|NCT03865927|Other|Placebo Oral Tablet|see Arm/Group description
16401372|NCT03865927|Drug|GKT137831|GKT137831 is a NOX enzyme inhibitor
16401373|NCT03854474|Biological|Pembrolizumab|Given IV
16401374|NCT03854474|Drug|Tazemetostat|Given PO
16401375|NCT03853109|Drug|AMG 404|AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.
16401376|NCT03844659|Other|"Song Weightless by Marconi Union"|"Patients will be randomized to the intervention group (the song Weightless by Marconi Union will be playing) during subjects labor epidural placement. The intervention in this study is solely the addition of music."
16401377|NCT03844659|Other|No Song|No song will be played during subjects labor epidural placement.
16401378|NCT03843554|Other|Standard of Care Oral Hygiene|Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.
16401379|NCT03843554|Procedure|Oral mucosal deterging and dental prophylaxis|Subjects will receive a professional dental prophylaxis including periodontal surface debridement [a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum] and deterging of the oral mucosal surfaces.
16401380|NCT03841682|Behavioral|I-CARE2|"I-CARE2 intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
~The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity."
16401381|NCT03837496|Other|STRIDE|STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
16401382|NCT03837496|Other|Medication Monitoring Control|Care provided as standard by the hospital and medication monitoring
16401383|NCT03833167|Biological|Pembrolizumab 400 mg|Administered by IV infusion on Day 1 of each 42-day cycle
16401384|NCT03833167|Drug|Placebo|Administered by IV infusion on Day 1 of each 42-day cycle
16401385|NCT03823521|Drug|Cardioplegia Solution|Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
16401386|NCT03821857|Diagnostic Test|18-F-Flortaucipir|Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
16401387|NCT03814590|Biological|RSV Vaccine (GSK3844766A) unadjuvanted low dose|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
16401388|NCT03814590|Biological|RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401389|NCT03814590|Biological|RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
16401390|NCT03814590|Biological|RSV Vaccine (GSK3844766A) unadjuvanted medium dose|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401391|NCT03814590|Biological|RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401392|NCT03814590|Biological|RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401393|NCT03814590|Biological|RSV Vaccine (GSK3844766A) unadjuvanted high dose|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401394|NCT03814590|Biological|RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
16401395|NCT03814590|Biological|RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401396|NCT03814590|Drug|Placebo (Saline solution)|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
16401397|NCT03811015|Drug|Cisplatin|Given IV
16401398|NCT03811015|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16401399|NCT03811015|Biological|Nivolumab|Given IV
16401400|NCT03811015|Other|Patient Observation|Undergo observation
16401409|NCT03808272|Device|HOT AXIOS Stent and Electrocautery- Enhanced Delivery System|The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.
16401419|NCT03741881|Other|No treatment given|Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).
16401420|NCT03740737|Drug|Follitropin delta|Follitropin delta
16401421|NCT03740737|Other|Placebo|Placebo
16401422|NCT03736512|Device|GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber|observational registry
16401423|NCT03736226|Device|SYNERGYTM Stent System|no intervention design in the study
16401424|NCT03734042|Biological|Platelet rich plasma intrauterine infusion|platelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11
16401425|NCT03734042|Biological|Normal saline|Intrauterine infusion of normal saline at day 11
16401428|NCT03732898|Device|New Programming Paradigm|A new programming paradigm will be evaluated.
16401429|NCT03717298|Dietary Supplement|Ocoxin-Viusid®|"An oral solution of Ocoxin-Viusid® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT.
~The treatment with Ocoxin-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment.
~The treatment will be administered continuously from the inclusion of the patient in the study, up to one year."
16401430|NCT03713671|Diagnostic Test|gait analysis|Computerized gait analysis system will use to evaluate spatio-temporal gait parameters
16401431|NCT03711747|Procedure|Osteochondral allograft ankle|Open osteochondral allograft to replace the cartilage that is grade four on the tibia and/or talus
16401434|NCT03704376|Drug|30 ml of 0.2% ropivacaine|
16401435|NCT03704376|Drug|15 ml of 0.2% ropivacaine|
16401436|NCT03704376|Drug|100 mcg clonidine|
16401437|NCT03704376|Device|High-frequency linear ultrasound transducer|
16401438|NCT03704298|Drug|Cyclophosphamide|Administered according to package insert
16401439|NCT03704298|Drug|Fludarabine|Administered according to package insert
16401440|NCT03704298|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
16401441|NCT03704298|Biological|Utomilumab|Administered as an IV infusion
16401442|NCT03701763|Drug|Apremilast (CC-10004)|Apremilast (CC-10004)
16401443|NCT03701763|Other|Placebo|Placebo
16401444|NCT03701334|Drug|Ribociclib|Ribociclib + ET
16401445|NCT03701334|Other|Endocrine Therapy|Endocrine Therapy (ET)
16401451|NCT03695939|Biological|Xeno-Skin™|3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1/2 Trial; an expansion cohort (9 patients) receive the highest dose.
16401452|NCT03695939|Biological|Human Cadaver Allograft|HCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts.
16401453|NCT03694483|Diagnostic Test|Genetic analysis for the detection of prostasomes|"Whole blood will be collected and processed within 2 hours. Samples will be brought to Hackensack University Medical Center and will be centrifuged.
~The plasma samples will be tested for presence of prostasomes using the ExoPLA (Exosome in situ Proximity Ligation Assay) assay and the prostasomes will be purified for further miRNA sequencing."
16401455|NCT03685591|Drug|PF-06952229|Oral 7 days on / 7 days off - 28 day cycles (Part 1)
16401456|NCT03685591|Drug|Enzalutamide|Prostate Cancer (Part 2). 160mg, capsules, orally, daily
16401461|NCT03677648|Drug|SHR0302|The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
16401462|NCT03677648|Drug|Placebos|Placebos
16401463|NCT03677154|Drug|Mosunetuzumab Intravenous (IV)|Participants in cohorts A and B will receive IV mosunetuzumab.
16401464|NCT03677154|Drug|Mosunetuzumab Subcutaneous (SC)|Participants in Cohort C will receive SC mosunetuzumab.
16401465|NCT03677154|Drug|Polatuzumab Vedotin|Participants in Cohort C will receive IV polatuzumab vedotin.
16401466|NCT03677154|Drug|Tocilizumab|Participants will receive tocilizumab via IV as needed to manage severe cytokine release syndrome (CRS).
16401467|NCT03672487|Drug|Benznidazole|Benznidazole tablet
16401468|NCT03672487|Drug|Placebo Oral Tablet|Sugar pill manufactured to mimic Benznidazole
16401571|NCT03461354|Drug|Sodium Bicarbonate|Sodium bicarbonate oral rinse
16401469|NCT03663712|Biological|Talimogene Laherparepvec|TVEC is an oncolytic, genetically modified virus designed to reproduce in tumor tissue and stimulate your immune system to attack the tumor cells
16401475|NCT03644953|Drug|Hydroxyurea|Participants will be started on hydroxyurea 20 ± 2.5 mg/kg/day in addition to continuing simple chronic transfusion every 4 weeks ± 1 week. Hydroxyurea will be dose escalated to achieve a HAT target dose (HAT-TD). Hydroxyurea will be increased by 5 mg/kg/day after 8 weeks of a dose if HAT-TD is not achieved (maximum daily dose 2,000 mg). After HAT-TD has been achieved, minor dose increases may occur if subject grows a significant amount to maintain the same mg/kg dose.
16401476|NCT03639324|Drug|Dose combination 1-1|100 mg QD of idelalisib + 100 mg QD of venetoclax
16401477|NCT03639324|Drug|dose combination 1-2|100 mg QD of idelalisib + 200 mg QD of venetoclax
16401478|NCT03639324|Drug|Dose combination 1-3|100 mg BID of idelalisib + 200 mg QD of venetoclax
16401479|NCT03639324|Drug|dose combination 1-4|150 mg BID of idelalisib + 200 mg QD of venetoclax
16401480|NCT03639324|Drug|Sub-Trial: Dose combination 2-1|100 mg BID of idelalisib + 100 mg QD of venetoclax
16401481|NCT03639324|Drug|Sub-Trial: Dose combination 2-2|150 mg BID of idelalisib + 100 mg QD of venetoclax
16401482|NCT03631199|Drug|canakinumab|canakinumab every 3 weeks (squamous and non-squamous)
16401483|NCT03631199|Drug|canakinumab matching placebo|canakinumab placebo every 3 weeks (squamous and non-squamous)
16401484|NCT03631199|Drug|pembrolizumab|200 mg every 3 weeks (squamous and non-squamous)
16401485|NCT03631199|Drug|carboplatin|AUC 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
16401486|NCT03631199|Drug|cisplatin|75 mg/m2 every 3 weeks (non-squamous)
16401487|NCT03631199|Drug|paclitaxel|200 mg/m2 every 3 weeks (squamous)
16401488|NCT03631199|Drug|nab-paclitaxel|100 mg/m2 every 3 weeks (squamous)
16401489|NCT03631199|Drug|pemetrexed|500 mg/m2 every 3 weeks (non-squamous)
16401490|NCT03626545|Drug|Canakinumab|Canakinumab, subcutaneous, administred at the recommended Phase III regimen (defined in the safety run-in part)
16401491|NCT03626545|Drug|Docetaxel|Standard of care: docetaxel 75mg/m2, intravenous, every 3 weeks
16401492|NCT03626545|Other|Placebo|Placebo, sub-cutaneous, administered at the recommended Phase III regimen (defined in the safety run-in part).
16401493|NCT03587740|Drug|T-DM1|T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
16401494|NCT03585595|Other|Blood pressure lowering strategy|The proposed trial will test a treatment strategy of different systolic BP goals and not specific medications. It remains unclear whether a particular class of antihypertensive drug offers an advantage over others in secondary stroke prevention. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications. However, we will emphasize the use of drugs best demonstrated to be effective in lowering CVD in outcome trials and recommended in current clinical guidelines.
16401500|NCT03568084|Other|MEFAP|multicomponent physical activity program (MEFAP) with 12 weekly sessions of an hour and a half which includes 1) briefing 2) exercises for improving aerobic resistance, muscle strength, proprioception-balance and flexibility and 3) delivery of exercise chart to do at home (two times per week).
16401501|NCT03568084|Other|control usual practice|Individuals allocated to this arm, will be look after as usual in their health Centers.
16401502|NCT03564340|Drug|REGN4018|REGN4018 will be administered in a series of dose escalation and dose expansion cohorts by intravenous (IV) infusion and/or subcutaneous (SC) as described in the protocol during 6-week cycle (42 days).
16401503|NCT03564340|Drug|cemiplimab|Cemiplimab will be administered by IV infusion once a REGN4018 monotherapy dose has been selected .
16401504|NCT03562897|Dietary Supplement|Ocoxin-Viusid|Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).
16401505|NCT03559543|Dietary Supplement|Ocoxin-Viusid|"An oral solution of Oncoxin® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT up to 3 weeks after finishing the treatment.
~The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment.
~The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study."
16401506|NCT03555149|Drug|Regorafenib|Regorafenib will be administered orally on Days 1-21 of each 28-day cycle.
16401507|NCT03555149|Drug|Atezolizumab|Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles, with the exception of the Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Idasanutlin, Atezolizumab + Regorafenib and Atezolizumab + Regorafenib + AB928 arms where the Atezolizumab will be administered by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.
16401508|NCT03555149|Drug|Imprime PGG|Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle.
16401509|NCT03555149|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion on Day 1 of each 21-day cycle for the Atezolizumab + Imprime PGG + Bevacizumab arm, and on Day 1 and Day 15 of each 28-day cycle for the Atezolizumab + Selicrelumab + Bevacizumab arm.
16401572|NCT03459443|Drug|Danicopan|Danicopan was administered as an oral tablet.
16401511|NCT03555149|Drug|Selicrelumab|Selicrelumab will be administered by subcutaneous (SC) injection on Day 1 of cycles 1-4 and every third cycle thereafter. Cycles will be 28 days long.
16401512|NCT03555149|Drug|Idasanutlin|Idasanutlin will be administered orally on Days 1-5 of each 28-day cycle.
16401513|NCT03555149|Drug|AB928|AB928 will be administered orally once daily on Days 1-28 of each 28-day cycle.
16401514|NCT03555149|Genetic|LOAd703|LOAd703 will be administered by intratumoral injection on Day 1 of each 21-day cycle.
16401515|NCT03553940|Biological|Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine|Live monovalent influenza A/H3N2-based M2SR (M2 defective Single Replication vaccine), comprised of 5 out of 8 gene segments on the donor virus influenza A/Puerto Rica/8/34. HA and NA derive from an A/Brisbane/10/2007-like virus. Administered intranasally as s single dose.
16401516|NCT03553940|Other|Placebo|H3N2 M2SR vaccine placebo (normal saline). Administered intranasally as a single dose.
16401517|NCT03553940|Biological|Quadrivalent MDCK Inactivated Influenza Vaccine|A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Administered intramuscularly as a single dose.
16401518|NCT03549494|Dietary Supplement|Ocoxin-Viusid®|Ocoxin-Viusid group (Experimental). Oral solution of Ocoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2
16401519|NCT03549273|Dietary Supplement|Glizigen® + Ocoxin-Viusid®|"Glizigen® spray, topical use, 2 times a day for 6 months with an interruption for 2 months at the end of the third month.
~Ocoxin®-Viusid® 60 ml daily (1 vial every 12 hours) by oral route for 8 months, preferably administered after breakfast and lunch, without interruption."
16401520|NCT03541850|Drug|Antiandrogen Therapy|Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen
16401521|NCT03541850|Other|Quality-of-Life Assessment|Ancillary studies
16401522|NCT03541850|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16401523|NCT03541005|Dietary Supplement|Obex|After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
16401524|NCT03541005|Dietary Supplement|Placebo|After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
16401525|NCT03531502|Procedure|Ventricular Tachycardia Ablation|Ventricular Tachycardia Ablation
16401526|NCT03531502|Other|Standard Medical Therapy|For the antiarrhythmic naïve patients, the attending physician may initiate therapy with sotalol or amiodarone. For patients already on therapy with sotalol or amiodarone, the attending physician may choose to either increase the dosage/ frequency of these medications and/or add mexiletine to the regimen. Other alterations to medical therapy, such as adjusting the dose of beta-blockers, calcium-channel blockers, anti-hypertensive, diuretic or anti-anginal medications may be performed at the discretion of the attending physician.
16401527|NCT03531502|Procedure|Non-Invasive Programmed Stimulation (NIPS)|All patients will receive this procedure in attempt to induce ventricular tachycardia. The outcome of this procedure determines if a patient will be randomized.
16401528|NCT03529890|Drug|Nivolumab|"Experimental intervention:
~Immunotherapy with 4 cycles of Nivolumab: 240 mg intravenously every 2 weeks, starting one week before radiotherapy (week1, d1), last infusion on week 7, d1"
16401529|NCT03529890|Radiation|Radiation therapy of the pelvis|Neoadjuvant radiation therapy of pelvis with 45+5,4 Gy for 6 weeks: 28 x 1.8 Gy including a boost of bladder with 5.4 Gy, starting with week 2 (d1)
16401530|NCT03529890|Procedure|Radical cystectomy with standardized pelvic lymphadenectomy|Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)
16401531|NCT03516981|Biological|Pembrolizumab|200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W
16401532|NCT03516981|Biological|Favezelimab|200 mg or 800 mg favezelimab solution for IV infusion administered Q3W
16401533|NCT03516981|Drug|Lenvatinib|20 mg lenvatinib capsules administered orally once daily
16401534|NCT03516981|Drug|Quavonlimab|Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)
16401538|NCT03511157|Other|Ischemic Preconditioning|See Ischemic Preconditioning Experimental group description
16401539|NCT03511157|Other|Control Group|See Control group description
16401540|NCT03500471|Procedure|Robotic-assisted Total Gastrectomy|Robotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
16401573|NCT03452137|Drug|Atezolizumab|Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
16401574|NCT03452137|Drug|Placebo|Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
16401541|NCT03500471|Procedure|Laparoscopic-assisted Total Gastrectomy|Laparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
16401542|NCT03498521|Drug|Alectinib|Alectinib will be administered orally at the label-recommended dose (600 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401543|NCT03498521|Drug|Vismodegib|Vismodegib will be administered orally at the label-recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401544|NCT03498521|Drug|Ipatasertib|Ipatasertib will be administered orally at the label-recommended dose (400 mg) once daily on Days 1-21 of each 28-day Cycle in combination with paclitaxel, and as monotherapy after the final administration of paclitaxel, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401545|NCT03498521|Drug|Olaparib|Olaparib will be administered orally at the label-recommended dose (400 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401546|NCT03498521|Drug|Erlotinib|Erlotinib will be administered orally in combination with Bevacizumab at the label recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401547|NCT03498521|Drug|Bevacizumab|Bevacizumab will be administered intravenously at 15mg/kg every 3 weeks in combination with Erlotinib until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401548|NCT03498521|Drug|Vemurafenib|Vemurafenib will be administered orally, 960 mg twice daily, in combination with Cobimetinib, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401549|NCT03498521|Drug|Cobimetinib|Cobimetinib will be administered orally, 60mg once daily, in combination with Vemurafenib, on Days 1-21 of each 28-day Cycle, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401550|NCT03498521|Drug|Trastuzumab Subcutaneous (SC)|Trastuzumab will be administered subcutaneously, 600 mg every 3 weeks, in combination with Pertuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401551|NCT03498521|Drug|Pertuzumab|Pertuzumab will be initially be administered intravenously, 840 mg, followed by 420 mg every 3 weeks, in combination with Trastuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months)
16401552|NCT03498521|Drug|Atezolizumab|Atezolizumab will be administered intravenously at the label-recommended dose (1200 mg), alone or in combination with chemotherapy, every 3 weeks until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401553|NCT03498521|Drug|Carboplatin|Carboplatin will be administered intravenously at the area under the curve (AUC) dose once every 3 weeks for up to 9 Cycles (Cycle = 21 days) in some combination with the following: Paclitaxel, Gemcitabine, Atezolizumab, Pertuzumab, and Trastuzumab SC.
16401554|NCT03498521|Drug|Paclitaxel|Paclitaxel will be administered intravenously, 175 mg/m^2, once every 3 weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Carboplatin, Ipatasertib, Atezolizumab, Pertuzumab, and Trastuzumab SC
16401555|NCT03498521|Drug|Cisplatin|Cisplatin will be administered intravenously, 60-75 mg/m^2, once every three weeks, for up to 9 cycles (Cycle = 21 days) in some combination with the following: Gemcitabine, Paclitaxel, Atezolizumab, Pertuzumab, and Trastuzumab SC.
16401556|NCT03498521|Drug|Gemcitabine|Gemcitabine will be administered intravenously, 1000 mg/m^2, twice every three weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Cisplatin, Carboplatin, Atezolizumab, Pertuzumab, and Trastuzumab SC.
16401557|NCT03498521|Drug|Entrectinib|Entrectinib will be administered orally at the label-recommended dose (600 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 60 months).
16401558|NCT03498521|Drug|Ivosidenib|Ivosidenib will be administered orally at the label-recommended dose (500mg) once daily across a 28-day treatment cycle until loss of clinical benefit or unacceptable toxicity.
16401559|NCT03498521|Drug|Pemigatinib|Pemigatinib will be administered orally at the label-recommended dose (13.5mg) once daily across a 21-day treatment cycle until loss of clinical benefit or unacceptable toxicity.
16401560|NCT03496597|Procedure|Retinal imaging assessment|"OCT-angiography
~Automated measurement program: size of the avascular zone and perifoveolar vascular density of the superficial capillary plexus
~Eye fundus photography: macular image
~Measurement of the fractal dimension of the retinal foveolar retina from photographs of the fundus"
16401561|NCT03496597|Procedure|blood glucose holter|for 40 subjects, implantation of a blood glucose holter monitor for 7 days
16401562|NCT03494335|Other|Online surveys|The investigators are recruiting health care providers for these surveys that are involved in or use imaging.
16401563|NCT03487575|Behavioral|Open trial|Integrated electronic support and care support manager contact
16401564|NCT03473977|Biological|Benralizumab|Benralizumab (anti-IL5Ra) will be injected every 4 weeks in doses of 30 mg (total of 3 injections) in subjects with active Eosinophilic Gastritis.
16401565|NCT03473977|Biological|Placebo|Placebo will be injected every 4 weeks (total of 3 injections) as a comparator to Benralizumab in subjects with active Eosinophilic Gastritis.
16401566|NCT03473223|Biological|Apolipoprotein A-I [human] (apoA-I)|Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration
16401567|NCT03473223|Other|Placebo|25% albumin solution diluted to 4.4%
16401568|NCT03467217|Drug|Losartan potassium|Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
16401569|NCT03467217|Drug|Placebo losartan capsule|Matching placebo losartan oral capsule
16401570|NCT03461354|Drug|MucoLox|MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine
16401575|NCT03451474|Procedure|Upper extremity nerve transfer surgery|Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.
16401576|NCT03447769|Drug|Canakinumab|Canakinumab will be administered periodically for approximately 54 weeks.
16401577|NCT03447769|Drug|Placebo|Placebo will be administered periodically for approximately 54 weeks.
16401578|NCT03445923|Other|Time lapse monitoring (KID Score)|The unique information that is obtainable from taking Pictures each 10 minutes throughout the development of the embryos will be used in the form of a special score (KID score). The score is comprised out of several key developmental parameters.
16401579|NCT03440437|Drug|FS118|Dosing of participants will occur intravenously (IV) weekly in 3-week treatment cycles until iCPD (i.e., immune confirmed progressive disease), unacceptable toxicity, or discontinuation.
16401580|NCT03429543|Drug|Linagliptin|Film Coated Tablet
16401581|NCT03429543|Drug|Empagliflozin|Film Coated Tablet
16401582|NCT03429543|Drug|Placebo|Film Coated Tablet
16401583|NCT03423628|Radiation|Radiation Therapy|"Arm A: 35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks) Arm B: 30 Gy of whole brain radiation therapy (WBRT) or partial brain radiation therapy (PBRT) administered at daily fractions of 3 Gy over 10 fractions (2 weeks).
~**Arm B has now closed to recruitment** Arm C: 60 Gy of intensity-modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)"
16401584|NCT03423628|Drug|AZD1390|"AZD1390 Administered in 3 Cycles depending on arm:
~Cycle 0 (arms A and C): 1 dose prior to Radiation Therapy. For optional food effect assessment in Arm A, 2 doses prior to RT under both fed and fasted conditions. *Note: the optional food effect assessment is currently not open to recruitment*.
~Cycle 1 (all arms): Intermittent or continuous dosing during Radiation Therapy (except for first 2 cohorts of Arm A).
~Cycle 2 (arms A and C): 2 weeks adjuvant treatment after Radiation Therapy."
16401585|NCT03415061|Drug|Regular Insulin, Human 100 UNT/ML|40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
16401586|NCT03415061|Drug|Normal Saline Flush, 0.9% Injectable Solution|Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
16401587|NCT03414684|Drug|Carboplatin|Carboplatin interferes with the development of the genetic material in a cell, which will cause the cancer cells to die.
16401588|NCT03414684|Drug|Nivolumab|Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cells
16401589|NCT03403621|Drug|Pentamidine Isethionate|Pentamidine isethionate prepared in a silicone base will be applied topically
16401590|NCT03403621|Drug|Silicone Gels|Silicone base will be applied topically
16401591|NCT03393936|Biological|CCT301-38|Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-38. During CCT301-38 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-38 by intravenous (IV) injection.
16401592|NCT03393936|Biological|CCT301-59|Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-59. During CCT301-59 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-59 by intravenous (IV) injection.
16401593|NCT03353740|Drug|Ga-68 labeled PSMA-11 PET|Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
16401594|NCT03342950|Drug|Topical Solution|Topical Solution of Clonidine (0.01%) + Pentoxifylline (5%) in anhydrous ethanol (6.5%), polyethylene glycol 400 (20%), propylene glycol (53.5%), and oleyl alcohol (20%)
16401595|NCT03342950|Drug|Placebos|Topical Solution of anhydrous ethanol (6.5%), polyethylene glycol 400 (20%), propylene glycol (53.5%), and oleyl alcohol (20%)
16401596|NCT03340506|Drug|dabrafenib|dabrafenib is available in capsules (50mg and 75mg) taken twice a day
16401597|NCT03340506|Drug|trametinib|trametinib is available in tablets (0.5mg, 2mg dose)
16401598|NCT03333655|Procedure|Biopsy|Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.
16401599|NCT03327844|Drug|RET using antibiotics (Ciprofloxacin and Metronidazole)|RET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.
16401600|NCT03327844|Drug|RET using non-setting Calcium Hydroxide|First Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.
16401601|NCT03325842|Diagnostic Test|ASKp|30 items questionnaire
16401675|NCT02963272|Other|Conventional strategy|Conventional strategy to manage the patients with HF, following the international guidelines.
16401602|NCT03308942|Drug|Niraparib|Niraparib is an orally available, potent, highly selective poly adenosine diphosphate- ribose (poly ADP-ribose) polymerase-1 (PARP-1) and PARP-2 inhibitor. It will be available as 100 milligrams (mg) capsules and will be administered as 2 X 100 mg capsules (200 mg per day) orally once daily (QD).
16401603|NCT03308942|Biological|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G-4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands (PD-L1 and PD-L2). It will be available as 50 mg lyophilized powder single-use vials or 100 mg/4 milliliters (mL) (25 mg/mL) solution in a single-dose vial. It will be administered at a dose of 200 mg intravenous (IV) using a 30-minute IV infusion
16401604|NCT03308942|Biological|TSR-042 (Dostarlimab)|TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. It will be administered at a dose of 500 mg for every 3 weeks (Q3W) for first 4 cycles followed by 1000 mg for every 6 weeks (Q6W) for all subsequent cycles using a 30-minute IV infusion. TSR-042 (dostarlimab) will be supplied as a solution of 160 mg (20 mg/mL) or 500 mg (50 mg/mL) in a single-dose vial.
16401605|NCT03301883|Drug|Tocilizumab|Tocilizumab will be administered as per the schedule specified in the arm description.
16401606|NCT03301883|Drug|NSAIDs|Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.
16401607|NCT03301883|Drug|CSs|Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.
16401608|NCT03301883|Drug|MTX|Participants may receive MTX at a stable dose of less than or equal to (</=) 20 milligrams per square meter (mg/m^2).
16401609|NCT03289273|Drug|Regorafenib (Stivarga, BAY73-4506)|As per the treating physicians discretion
16401610|NCT03280563|Drug|Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody|Atezolizumab will be given as 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle. This regimen will apply to all arms except when given with entinostat in Stage 1, or exemestane or tamoxifen in Stage 2, in which atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle.
16401611|NCT03280563|Drug|Bevacizumab|Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 15 of each 28-day cycle in the regimen containing fulvestrant. When given with exemestane or tamoxifen, bevacizumab will be given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.
16401612|NCT03280563|Drug|Entinostat|Entinostat will be given as 5 mg orally once a week on Days 1, 8 and 15 of each 21-day cycle.
16401613|NCT03280563|Drug|Exemestane|Exemestane will be given as 25 mg orally QD in each 21-day cycle.
16401614|NCT03280563|Drug|Fulvestrant|Fulvestrant will be given as 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.
16401615|NCT03280563|Drug|Ipatasertib|Ipatasertib will be given as 400 mg orally QD on Days 1-21 of each 28-day cycle.
16401616|NCT03280563|Drug|Tamoxifen|Tamoxifen will be given as 20 mg orally QD in each 21-day cycle.
16401617|NCT03280563|Drug|Abemaciclib|Abemaciclib will be given as 150mg twice daily during each 28-day cycle.
16401618|NCT03273751|Procedure|Remote Ischemic Preconditioning|After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.
16401619|NCT03273751|Procedure|Sham control|After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.
16401620|NCT03273023|Device|Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System|Promus PREMIERTM Stent System
16401621|NCT03271554|Drug|Alectinib|According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).
16401622|NCT03270891|Diagnostic Test|PGx test|A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.
16401623|NCT03269136|Drug|PF-06863135 monotherapy IV or SC|PF-06863135 will be administered intravenously or subcutaneously.
16401624|NCT03269136|Drug|PF-06863135 + dexamethasone|PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
16401625|NCT03269136|Drug|PF-06863135 + lenalidomide|PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
16401626|NCT03269136|Drug|PF-06863135 + pomalidomide|PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
16401627|NCT03259425|Drug|Nivolumab|Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then participant will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.
16401628|NCT03259425|Drug|HF10|1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections. All eligible tumors except one will be treated with HF10 up to the maximum volume allowed. The untreated tumor will be used as an untreated control lesion.
16401629|NCT03234608|Behavioral|AASPIRE Healthcare Toolkit|The AASPIRE Healthcare Toolkit includes a variety of resources (information, worksheets, checklists, links) for patients and providers. The centerpiece of the toolkit is the Autism Healthcare Accommodations Tool, which allows a patient or their supporter to create a personalized accommodations report for the patient's provider. Intervention patients will use the toolkit and create an AHAT report. Intervention clinics will receive a copy of each patient's AHAT report, place it in the medical record, and share it with the patient's PCP and other staff.
16401638|NCT03152773|Procedure|MRI Heart guidewire catheterization|to conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.
16401639|NCT03100370|Device|tsDCS-Anodal Stimulation|2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
16401640|NCT03100370|Device|tsDCS-Cathodal Stimulation|2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
16401641|NCT03100370|Device|tsDCS-Sham Stimulation|2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
16401642|NCT03074045|Drug|Levonorgestrel (Kyleena, BAY86-5028)|Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years
16401643|NCT03074045|Drug|Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)|COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months
16401649|NCT03055871|Behavioral|Habit formation intervention|In addition to the control content and the planning content, this intervention will include material provided to the family that assists with creating physical activity support habits. The material contains a discussion of what habits are, straightforward examples, planning and pointers for forming habits. A key component of the habit intervention will be planning for context-dependent repetition.
16401650|NCT03055871|Behavioral|Physical activity planning intervention|This arm will receive the control education content, but will also be provided with family PA planning material. This material will include skill training content (workbook on how to plan for family PA). The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We also have Canadian parental survey data on the most preferred co-physical activities for children 3-6. We will provide this material as prompts/suggestions. This list helps create the template for PA planning by contextualizing what the parents would like to do with their kids.
16401651|NCT03041649|Other|GT button change - Mic-Key|After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
16401652|NCT03041649|Other|GT button change - Mini One|After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
16401653|NCT03022539|Radiation|Repeat CT scan|
16401654|NCT03019510|Behavioral|No exercise|No exercise will be done on the day of the study night to be tested
16401655|NCT03019510|Behavioral|Morning exercise|Early morning exercise will be done on the day of the study night to be tested
16401656|NCT03019510|Behavioral|Evening exercise|Evening exercise will be done on the day of the study night to be tested
16401657|NCT03002207|Device|Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge|Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
16401658|NCT03002207|Procedure|The defect is sutured|Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.
16401659|NCT03000179|Drug|Avelumab|Avelumab through a vein once every 2 weeks
16401660|NCT02998645|Drug|eltrombopag|Film-coated tablets (12.5 mg, 25 mg, 50 mg and 75 mg) administered orally, once daily. Dosing is done according to age and ethnicity (East Asian)
16401661|NCT02998645|Drug|Cyclosporine|"Supplied in oral soft gel capsules or oral solution and dosage is based on body weight and administered every 12 hours. Dosing is titrated individually according to therapeutic trough level for 6 months. After 6 months (for responders), tapering of cyclosporine must be done as follows:
~6-9 months: at the 6 months visit, the dose must be reduced by 25% for 3 months
~9-12 months: at the 9 months visit, the dose must be further reduced by 25% for another 3 months
~12-24 months: maintain dose"
16401669|NCT02990338|Drug|Isatuximab|Pharmaceutical form:solution for infusion Route of administration: intravenous
16401670|NCT02990338|Drug|Pomalidomide|Pharmaceutical form:capsule Route of administration: oral
16401671|NCT02990338|Drug|Dexamethasone|Pharmaceutical form:tablets or solution for infusion Route of administration: oral or intravenous
16401672|NCT02972853|Behavioral|Mindfulness Training for Primary Care (MTPC)|"For intervention description see Mindfulness Training for Primary Care (MTPC) in the study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study"
16401673|NCT02968602|Drug|Minocycline|Minocycline capsules taken twice daily for two weeks.
16401764|NCT02595866|Other|Laboratory Biomarker Analysis|Correlative studies
16401676|NCT02963272|Other|ST2-guided strategy|patients wit ST2 over the median are targeted with higher doses of drugs with putative effects on fibrosis and anti HF pathophysiology
16401677|NCT02962414|Drug|everolimus|everolimus, 2mg dispersible tablets
16401678|NCT02958865|Drug|PF-06651600 or Placebo|Delivered orally for 8 weeks.
16401679|NCT02958865|Drug|PF-06700841 or Placebo|Delivered orally for 8 weeks.
16401680|NCT02958865|Drug|PF-06700841|Delivered orally for 24 weeks.
16401681|NCT02958865|Drug|PF-06651600|Delivered orally for 24 weeks.
16401682|NCT02954510|Drug|ferumoxytol|ferumoxytol will assess patency of coronary arteries
16401683|NCT02953665|Drug|Liraglutide|Liraglutide 6 mg/ml once daily at a maximum dose of 1.8 mg
16401684|NCT02953665|Drug|Placebo|Placebo (for Liraglutide) 6 mg/ml once daily at a maximum dose of 1.8 mg
16401685|NCT02944071|Device|Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter|
16401686|NCT02941926|Drug|Ribociclib|Ribociclib oral (3 weeks on/1 week off), 600 mg ribociclib QD
16401687|NCT02941926|Drug|Letrozole|Oral once daily, 2.5 mg letrozole QD
16401688|NCT02941926|Drug|Goserelin|Only for men and premenopausal women: administered as an injectable subcutaneous implant once every 28 days
16401689|NCT02941926|Drug|Leuprolide|Only for men and premenopausal women: administered as an injectable intramuscular depot once every 28 days
16401703|NCT02879695|Biological|Blinatumomab|Given IV
16401704|NCT02879695|Biological|Ipilimumab|Given IV
16401705|NCT02879695|Biological|Nivolumab|Given IV
16401718|NCT02850536|Biological|anti-CEA CAR-T cells|Gene modified patient T cells
16401719|NCT02841397|Device|Masimo Pulse CO-Oximeter|Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index
16401723|NCT02831764|Drug|Dolutegravir (DTG)|DTG is available as 50 mg white, round, biconvex, film coated tablet debossed on one side with 'SV 572' and on the other side with '50'. The tablets are packaged into high density polyethylene (HDPE) bottles with induction seals and child resistant closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will be orally administered once daily with or without food upto 148 weeks.
16401724|NCT02831764|Drug|Lamivudine (3TC)|Lamivudine is available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets debossed with 'GX CJ7' on both sides, packed in over labelled HDPE bottles with child-resistant closures each containing 30 tablets.
16401725|NCT02831764|Drug|Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)|Tenofovir disoproxil fumarate and Emtricitabine are available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated tenofovir disoproxil fumarate/emtricitabine tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film coated tablets debossed with 'GILEAD' on one side and '701' on another side, packed in overlabelled HDPE bottles with polypropylene childresistant closures each containing 30 tablets and a desiccant.
16401726|NCT02831673|Drug|Dolutegravir (DTG)|DTG is available as 50 mg white, round, biconvex, film coated tablet debossed on one side with 'SV 572' and on the other side with '50'. The tablets are packaged into high density polyethylene (HDPE) bottles with induction seals and child resistant closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will be orally administered once daily with or without food upto 148 weeks.
16401765|NCT02595866|Biological|Pembrolizumab|Given IV
16401766|NCT02590380|Device|MESA Rail Deformity System|The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.
16401831|NCT02306161|Drug|Vincristine Sulfate|Given IV
16401832|NCT02294461|Drug|Enzalutamide|Oral
16401727|NCT02831673|Drug|Lamivudine (3TC)|Lamivudine is available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets debossed with 'GX CJ7' on both sides, packed in over labelled HDPE bottles with child-resistant closures each containing 30 tablets.
16401728|NCT02831673|Drug|Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)|Tenofovir disoproxil fumarate and Emtricitabine are available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated tenofovir disoproxil fumarate/emtricitabine tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film coated tablets debossed with 'GILEAD' on one side and '701' on another side, packed in overlabelled HDPE bottles with polypropylene childresistant closures each containing 30 tablets and a desiccant.
16401729|NCT02813785|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
16401730|NCT02813785|Drug|Docetaxel|Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.
16401731|NCT02807636|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
16401732|NCT02807636|Drug|Carboplatin|Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
16401733|NCT02807636|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
16401734|NCT02807636|Other|Placebo|Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
16401735|NCT02807636|Drug|Cisplatin|Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
16401736|NCT02764762|Drug|Vedolizumab|Vedolizumab intravenous infusion.
16401737|NCT02764762|Drug|Adalimumab|Adalimumab injection for subcutaneous use.
16401738|NCT02764762|Drug|Methotrexate|Methotrexate oral tablets.
16401739|NCT02757872|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day
16401740|NCT02757872|Drug|Omega-3 Fatty acids|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
16401741|NCT02757872|Dietary Supplement|Vitamin D3 placebo|Vitamin D3 placebo
16401742|NCT02757872|Dietary Supplement|Fish oil placebo|Fish oil placebo
16401743|NCT02750605|Device|DEB|Intervention with drug eluting balloon.
16401744|NCT02750605|Device|POBA|Intervention with old technology as comparison
16401745|NCT02721654|Drug|Plasma-Lyte 148®|Plasma-Lyte 148 (approx pH 7.4) IV infusion is a sterile, clear nonpyrogenic isotonic solution & when administered intravenously it is a source of water, electrolytes & calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water & electrolytes or as an alkalinising agent.
16401746|NCT02721654|Drug|0.9% sodium chloride|The active ingredient is sodium chloride formulated in Water for Injections. The chemical name is sodium chloride with molecular formula NaCl. Sodium Chloride (0.9%) intravenous infusion preparation is a sterile & non-pyrogenic solution & is indicated for extracellular fluid replacement & in the management of metabolic alkalosis in the presence of fluid loss, & for restoring or maintaining the concentration of sodium & chloride ions. As sodium chloride intravenous infusion is administered to the systemic circulation by intravenous infusion, the bioavailability (absorption) of the active components is complete (100 per cent).
16401747|NCT02720185|Drug|Dasatinib|100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
16401748|NCT02720185|Procedure|Conventional Surgery|Undergo surgery
16401749|NCT02720185|Other|Laboratory Biomarker Analysis|Correlative studies
16401750|NCT02702687|Behavioral|PEF Feedback|Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
16401751|NCT02702687|Behavioral|Control Feedback|Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.
16401752|NCT02691962|Device|Xen Matrix AB|Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier.
16401753|NCT02682784|Drug|Oxytocin|Nasal spray based on naturally occurring hormone, oxytocin.
16401754|NCT02682784|Drug|Placebo|
16401755|NCT02675465|Drug|ATB200|
16401756|NCT02675465|Drug|AT2221|
16401757|NCT02663908|Drug|Degarelix|
16401758|NCT02663908|Drug|Leuprolide|
16401759|NCT02660827|Device|Insulin Pump|Closed Loop Algorithm
16401760|NCT02628067|Biological|pembrolizumab|intravenous infusion
16401761|NCT02628067|Biological|pembrolizumab|intravenous infusion
16401762|NCT02624180|Drug|Colchicine|Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
16401763|NCT02624180|Drug|Placebo|A substance containing no medication
16401767|NCT02590380|Device|DePuy Synthes USS II System|The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.
16401768|NCT02584933|Drug|ceritinib|hard gelatin capsule or hard tablet for oral use up to 750 mg
16401769|NCT02549937|Drug|surufatinib|orally once daily (QD) in patients with advanced solid tumor.
16401770|NCT02527421|Drug|DFD01 Spray|DFD-01 (betamethasone dipropionate) Spray, 0.05%
16401771|NCT02520427|Drug|AMG 330|0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
16401772|NCT02514148|Behavioral|Therapeutic patient education|Therapeutic patient education based on pain physiology from a biobehavioral perspective adding a training in coping strategies.
16401773|NCT02514148|Other|Therapeutic exercise|Therapeutic exercise consist on stretch of cervical-scapular muscles ( Trapezius and angular of the scapula), Cranium-cervical flexor stabilization exercise, auto cervical tractions, shoulders rotation, low intensity exercise ( walking), craniocervical extension, cervical flexion and extension.
16401774|NCT02514148|Other|No intervention|No intervention consist on measure the whole variables in chronic migraine patients to compare it with experimental interventions
16401775|NCT02514148|Other|Manual Therapy|Manual therapy consist on ; oscillatory traction , maintained craniocervical traction, upper cervical flexion mobilization, side glide roll, anterior-posterior upper cervical mobilization with wedge, lateral glide at the C1-C2 and C2-C3 levels, retraction technique, trigeminocervical neural mobilization , and upper cervical traction, followed by posterior-anterior glide at C4.
16401776|NCT02498613|Other|18F-Fluoromisonidazole|Correlative studies
16401777|NCT02498613|Drug|Cediranib Maleate|Given PO
16401778|NCT02498613|Other|Laboratory Biomarker Analysis|Correlative studies
16401779|NCT02498613|Drug|Olaparib|Given PO
16401780|NCT02498613|Procedure|Positron Emission Tomography|Correlative studies
16401781|NCT02484443|Biological|Dinutuximab|Given IV
16401782|NCT02484443|Other|Laboratory Biomarker Analysis|Correlative studies
16401783|NCT02484443|Other|Pharmacological Study|Correlative studies
16401784|NCT02484443|Biological|Sargramostim|Given SC
16401785|NCT02454933|Drug|AZD9291|Once daily tablet 80 mg
16401786|NCT02454933|Drug|MEDI4736|10mg/kg q2w (IV) infusion
16401787|NCT02453620|Drug|Entinostat|Given PO
16401788|NCT02453620|Biological|Ipilimumab|Given IV
16401789|NCT02453620|Biological|Nivolumab|Given IV
16401790|NCT02453620|Other|Pharmacogenomic Study|Correlative studies
16401791|NCT02453620|Other|Pharmacological Study|Correlative studies
16401792|NCT02435212|Drug|Deferasirox granule formulation|Deferasirox granules will be provided as stick packs containing 90 mg, 180 mg and 360 mg granules for oral use.
16401793|NCT02435212|Drug|Deferasirox DT formulation|Deferasirox DT will be provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use
16401794|NCT02420821|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.
16401795|NCT02420821|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.
16401796|NCT02420821|Drug|Sunitinib|Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.
16401797|NCT02414139|Drug|INC280 (capmatinib)|
16401798|NCT02408861|Biological|Ipilimumab|Given IV
16401799|NCT02408861|Biological|Nivolumab|Given IV
16401801|NCT02370901|Device|Helmet|Custom fitting helmet, FDA approved, to allow reshaping of the infant skull
16401802|NCT02370901|Behavioral|home therapies|parents will be instructed to do home neck stretching exercises, as well as repositioning techniques to keep baby off the flat spot. They will also be offered reassurance.
16401803|NCT02366091|Drug|Methotrexate|Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
16401804|NCT02366091|Drug|Colchicine|Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
16401805|NCT02366091|Drug|Placebo|Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
16401806|NCT02359565|Procedure|Diffusion Tensor Imaging|Correlative studies
16401807|NCT02359565|Procedure|Diffusion Weighted Imaging|Correlative studies
16401808|NCT02359565|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
16401809|NCT02359565|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
16401810|NCT02359565|Other|Laboratory Biomarker Analysis|Correlative studies
16401811|NCT02359565|Procedure|Magnetic Resonance Spectroscopic Imaging|Correlative studies
16401812|NCT02359565|Biological|Pembrolizumab|Given IV
16401813|NCT02359565|Procedure|Perfusion Magnetic Resonance Imaging|Correlative studies
16401814|NCT02354586|Drug|Niraparib|
16401815|NCT02351700|Drug|IV Caldolor|IV Caldolor (IV ibuprofen) intraoperatively and postoperatively
16401816|NCT02351700|Drug|IV Placebo|IV Placebo intraoperatively and postoperatively
16401817|NCT02322073|Procedure|Laparoscopic surgery|Roux-en-Y gastric bypass or other benign laparoscopic surgery
16401818|NCT02314169|Biological|Ipilimumab|Given IV
16401819|NCT02314169|Biological|Nivolumab|Given IV
16401820|NCT02306161|Drug|Cyclophosphamide|Given IV
16401821|NCT02306161|Drug|Doxorubicin|Given IV
16401822|NCT02306161|Drug|Doxorubicin Hydrochloride|Given IV
16401823|NCT02306161|Drug|Etoposide|Given IV
16401824|NCT02306161|Drug|Etoposide Phosphate|Given IV
16401825|NCT02306161|Radiation|External Beam Radiation Therapy|Undergo EBRT
16401826|NCT02306161|Biological|Ganitumab|Given IV
16401827|NCT02306161|Drug|Ifosfamide|Given IV
16401828|NCT02306161|Radiation|Stereotactic Radiosurgery|Undergo SBRT
16401829|NCT02306161|Procedure|Therapeutic Surgical Procedure|Undergo surgery
16401830|NCT02306161|Drug|Vincristine|Given IV
16401849|NCT02193048|Other|This study will evaluate a new clinical scoring system in patients receiving routine treatment|Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.
16401850|NCT02188264|Drug|Cyclosporine|Given PO
16401851|NCT02188264|Other|Laboratory Biomarker Analysis|Correlative studies
16401852|NCT02188264|Other|Pharmacological Study|Correlative studies
16401853|NCT02188264|Drug|Selumetinib|Given PO
16401854|NCT02173080|Other|PLD-Q|polycystic liver disease questionnaire
16401855|NCT02152982|Other|Laboratory Biomarker Analysis|Correlative studies
16401856|NCT02152982|Other|Placebo Administration|Given PO
16401857|NCT02152982|Other|Quality-of-Life Assessment|Ancillary studies
16401858|NCT02152982|Drug|Temozolomide|Given PO
16401859|NCT02152982|Drug|Veliparib|Given PO
16401860|NCT02149823|Drug|Syntocinon 24 Intranasal Units (IU)|
16401861|NCT02149823|Drug|Syntocinon 40 Intranasal Units (IU)|
16401862|NCT02149823|Drug|Intranasal Placebo|
16401863|NCT02141074|Drug|nonacog beta pegol|For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.
16401865|NCT02129361|Behavioral|Adapted Screening and Brief Intervention (Adapted SBI)|
16401866|NCT02129361|Behavioral|Screening & Education Attention Control|
16401867|NCT02101905|Other|Laboratory Biomarker Analysis|Correlative studies
16401868|NCT02101905|Drug|Lapatinib|Given PO
16401869|NCT02101905|Drug|Lapatinib Ditosylate|Given PO
16401870|NCT02101905|Other|Pharmacological Study|Correlative studies
16401871|NCT02101905|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection of tumor
16401872|NCT02088853|Dietary Supplement|high fat diet (hfd)|Sixty % of the energy content is based on fat.
16401873|NCT02088853|Dietary Supplement|high carb diet|Sixty % of the energy content is based on carbohydrates.
16401874|NCT02008292|Drug|Physostigmine|All subjects will receive physostigmine to induce elevated ACh levels in the brain.
16401875|NCT01969643|Drug|ladiratuzumab vedotin|LV will be given into the vein (IV; intravenously)
16401876|NCT01969643|Drug|Trastuzumab|Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
16401877|NCT01961375|Drug|Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)|Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
16401878|NCT01958021|Drug|LEE011|Ribociclib was administered orally at a dose of 600 mg once daily (three 200 mg capsules).
16401879|NCT01958021|Drug|Letrozole|Letrozole 2.5 mg tablets taken orally.
16401880|NCT01958021|Drug|LEE011 Placebo|Matching ribociclib placebo was the control drug and was administered orally once daily.
16401881|NCT01952288|Drug|simvastatin|simvastatin 40 mg/day for 12 months
16401882|NCT01952288|Drug|Placebo Oral Tablet|placebo comparator
16401883|NCT01843374|Drug|Tremelimumab|Tremelimumab is to be administered as an IV solution, followed by observation.
16401884|NCT01843374|Drug|Placebo|Placebo is to be administered as an IV solution, followed by observation.
16401885|NCT01828112|Drug|Ceritinib|Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.
16401886|NCT01828112|Drug|pemetrexed|Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days.
16401887|NCT01828112|Drug|docetaxel|Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days.
16401888|NCT01823393|Drug|Heparin|Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure
16401889|NCT01823393|Drug|NaCl|valvuloplasty is performed without heparin (placebo injection)
16401890|NCT01810913|Drug|Atezolizumab|Given IV
16401891|NCT01810913|Biological|Cetuximab|Given IV
16401892|NCT01810913|Drug|Cisplatin|Given IV
16401893|NCT01810913|Drug|Docetaxel|Given IV
16401894|NCT01810913|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16401895|NCT01810913|Other|Laboratory Biomarker Analysis|Correlative studies
16401896|NCT01810913|Other|Quality-of-Life Assessment|Ancillary studies
16401897|NCT01771107|Drug|Brentuximab Vedotin|Given IV
16401898|NCT01771107|Drug|Dacarbazine|Given IV
16401899|NCT01771107|Drug|Doxorubicin Hydrochloride|Given IV
16401900|NCT01771107|Other|Pharmacological Study|Correlative studies
16401901|NCT01771107|Drug|Vinblastine|Given IV
16401902|NCT01708954|Drug|Cabozantinib S-malate|Given PO
16401903|NCT01708954|Drug|Erlotinib Hydrochloride|Given PO
16401904|NCT01708954|Other|Laboratory Biomarker Analysis|Correlative studies
16401905|NCT01678872|Drug|RetinoStat|Long Term Follow up of patients who received RetinoStat in a previous study
16401906|NCT01620658|Device|0.5mm XPF cap|"Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
16401907|NCT01620658|Device|0.3mm XPF cap|"Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
~XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material."
16401908|NCT01620658|Device|Standard cap|Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
16401909|NCT01608152|Behavioral|Focus Group|Attend a focus group
16401910|NCT01608152|Other|Internet-Based Intervention|Have access to the game
16401911|NCT01608152|Behavioral|Interview|1 week after the 3-week period ends, interview conducted over the phone or at a clinic visit.
16401915|NCT01425398|Drug|Rosuvastatin|Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
16401916|NCT01425398|Drug|Placebo|Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.
16401917|NCT01420393|Procedure|Rhythm control|Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
16401918|NCT01420393|Other|Rate Control|Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
16401919|NCT01271621|Device|Intubation|Endotracheal intubation
16401920|NCT01236547|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16401921|NCT01236547|Drug|Paclitaxel|Given IV
16401922|NCT01236547|Drug|Pazopanib Hydrochloride|Given PO
16401923|NCT01236547|Other|Placebo Administration|Given PO
16401924|NCT01209234|Behavioral|Standard-of-Care Education|Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
16401925|NCT01209234|Drug|MRSA Decolonization|Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
16401926|NCT01142388|Biological|Cixutumumab|Given IV
16401927|NCT01142388|Other|Laboratory Biomarker Analysis|Correlative studies
16401928|NCT01142388|Drug|Paclitaxel|Given IV
16401929|NCT01142388|Other|Pharmacological Study|Correlative studies
16401930|NCT01089101|Other|Laboratory Biomarker Analysis|Correlative studies
16401931|NCT01089101|Other|Pharmacological Study|Correlative studies
16401932|NCT01089101|Drug|Selumetinib|Given PO
16401933|NCT01019018|Device|subtenon block|subtenon block with stevens cannula
16401934|NCT01019018|Device|subtenon block|subtenon block with Olive tip cannula cannula
16401935|NCT00992472|Drug|Prochlorperazine suppositories, 25mg|
16401936|NCT00992472|Drug|Compazine® suppositories, 25mg|
16401937|NCT00992238|Drug|Flavoxate Hydrochloride Tablets, 100mg|
16401938|NCT00992238|Drug|Urispas® Tablets, 100mg|
16401939|NCT00972478|Drug|Cyclophosphamide|Given IV
16401940|NCT00972478|Drug|Doxorubicin Hydrochloride|Given IV
16401941|NCT00972478|Other|Laboratory Biomarker Analysis|Correlative studies
16401942|NCT00972478|Drug|Prednisone|Given IV
16401943|NCT00972478|Biological|Rituximab|Given IV
16401944|NCT00972478|Drug|Vincristine Sulfate|Given IV
16401945|NCT00972478|Drug|Vorinostat|Given PO
16401946|NCT00967785|Drug|Mozobil (TM)|
16401947|NCT00929617|Behavioral|Experimental 1: exercise with 2 counseling types|Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
16401948|NCT00929617|Other|Usual Care - written materials|Patients will receive written materials about exercise for cancer survivors
16401949|NCT00785291|Biological|Bevacizumab|Given IV
16401950|NCT00785291|Drug|Ixabepilone|Given IV
16401951|NCT00785291|Other|Laboratory Biomarker Analysis|Correlative studies
16401952|NCT00785291|Drug|Nab-paclitaxel|Given IV
16401953|NCT00785291|Drug|Paclitaxel|Given IV
16401954|NCT00785291|Other|Questionnaire Administration|Ancillary studies
16401955|NCT00770809|Other|Laboratory Biomarker Analysis|Correlative studies
16401956|NCT00770809|Drug|Lapatinib Ditosylate|Given PO
16401957|NCT00770809|Drug|Paclitaxel|Given IV
16401958|NCT00770809|Biological|Trastuzumab|Given IV
16401961|NCT00628745|Other|None. Observational Study.|
16401962|NCT00588770|Biological|Bevacizumab|Given IV
16401963|NCT00588770|Drug|Carboplatin|Given IV
16401964|NCT00588770|Drug|Cisplatin|Given IV
16401965|NCT00588770|Drug|Docetaxel|Given IV
16401966|NCT00588770|Drug|Fluorouracil|Given IV
16401967|NCT00588770|Other|Laboratory Biomarker Analysis|Correlative studies
16401968|NCT00440830|Drug|nicotine patch|nicotine patch (0,5,10 or 15mg/day) applied to smokers
16401969|NCT00440830|Drug|nicotine patch|nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
16401970|NCT00440830|Drug|placebo|placebo patch applied to smokers
16401971|NCT00440830|Drug|placebo|placebo patch applied to nonsmokers
16401972|NCT00265798|Drug|Sorafenib Tosylate|
16401973|NCT00227253|Procedure|Determination of growth hormone status|Growth hormone stimulating testing using Arginine and Clonidine, Corticotrophin releasing hormone stimulation test
16401974|NCT00227253|Procedure|Measurement of growth, thyroid and sex hormone levels|Gonadotrophin releasing hormone stimulation test Thyroid testing - T4, TSH, T3 uptake, and anti-thyroidal antibodies baseline sample - no medication administered
16402144|NCT05089409|Other|Placebo|The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
16401975|NCT00227253|Procedure|Behavior and neuropsychometric evaluations|evaluation by neuropsychologist, standardized testing geared to study participant's age, abilities and past medical history
16401976|NCT00227253|Procedure|Audiological and ear, nose and throat examination|neurotological exam, behavioral audiometry, immittance audiometry, assessment of the function of the inner ear using otoacoustic emissions, Auditory brain responses
16401977|NCT00227253|Procedure|Magnetic resonance imaging of the brain|MRI of the brain - standard clinical procedure
16401978|NCT00227253|Procedure|Dysmorphology evaluation|Genetic evaluation with picture and measurements, physical exam
16401979|NCT00227253|Procedure|Neurology examination|physical examination including observation of balance, coordination and reflexes.
16401980|NCT00227253|Procedure|Dental evaluation|Visual detal inspection with panorex X-ray of the entire mouth
16401981|NCT00227253|Procedure|Speech pathology evaluation|Standardized speech & language tests and naturalistic assessment procedures.
16401982|NCT00227253|Procedure|Psychiatric evaluation|Psychiatric interview about history of psychiatric and medical illnesses, family psychiatric and medical history, demographic info also obtained
16401983|NCT00227253|Procedure|Orthopedic evaluation|Physical exam by orthopedic surgeon and a dysplasia series of radiographs including AP and lateral radiographics of the feet, APs of the knees, pelvis, thoracic lumbar spine and chest, laterals of thoracic lumbar and cervical spine, lateral of the skull, AP and lateral of the forearm, bone age evaluation with radiograph of left hand
16401984|NCT00227253|Procedure|Ophthalmologic evaluation|exam will determine visual acuity using one of the following: Snellen chart, Allen acuity, target acuity, optokinetic nystagmus (OKN), or Teller acuity depending on study participants ability level. Motility/alignment will also be determined using cover/uncover test. Pupils examined using slit lamp. Dilated fundus exam and cycloplegic refraction which will require dilating drops in both eyes. Cyclogen 1% and NeuSynephrine 2.5% are using. In children less than 6 months old, less potent mydriatrics and cycloplegics are used Cyclogel 0.5% or Tropicamide 1%. Intraocular pressure will be measured in adults and cooperative teens using applanation tonometry. A topical anesthetic will be used to perform this measurement.
16401985|NCT00227253|Procedure|Gastrointestinal evaluation|physical exam and medical history by board certified gastroenterologist.
16401986|NCT05090553|Procedure|Lumbar Spinal Fusion Surgery|During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
16401987|NCT05090553|Biological|Bacterial culture|Samples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days
16401988|NCT05090553|Genetic|Phenotypic and genotypic characterization|"The phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment.
~PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers."
16401989|NCT05090553|Genetic|Multiomics analysis|Whole Genome Sequencing, proteomics and metabolomics analysis
16401990|NCT05090540|Device|Trancatheter Edge to Edge Repair|TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation
16401991|NCT05090540|Procedure|Mitral Valve Replacement|Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.
16401992|NCT05090540|Procedure|Restrictive Mitral Annuloplastie|Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring
16401993|NCT05090540|Procedure|Restrictive Mitral Annuloplastie/Subvalvular Repair|RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.
16401994|NCT05090527|Diagnostic Test|Risk stratification|advanced penicillin challenge after risk stratification
16401995|NCT05090514|Behavioral|Reading and Growth Mindset|Parents and students receive a packet of age-appropriate books and educational materials (flyer/handouts, link to educational video) on how to read together/promote reading with their child using growth mindset strategies and where to find other reading materials. Parents also receive 2 weekly text messages with tips and reminders to read with their child daily for 20 minutes over the course of 8 weeks. The messages contain a link to a secure Redcap survey to log days and time spent reading the prior week.
16401996|NCT05090514|Behavioral|Wait-list Control|Parents and students receive a packet of age-appropriate books at the same time as the intervention group, but do not receive specialized instruction or reminders to read or any information on growth mindset and reading.
16401997|NCT05090501|Behavioral|Nature-based High Intensity Circuit Training|In a natural park, the participants will execute a 12-exercise High Intensity Circuit Training protocol. Each exercise will have an active part taking 60 seconds, in which exercisers are encouraged to do as many repetitions as possible, and a resting part taking 30 seconds in which the participants rest and are informed of the next exercise. Before and after the 12-exercise routine, the participants rate their affect, arousal and perceived exertion, while using a heart rate monitor and two IMU sensors on their arms and legs.
16402061|NCT05090072|Behavioral|Control|The palliative care physician undergone a conference with both patients and caregivers and evaluated patients' symptoms using the the Edmonton Frail Scale (Bruera, 1991), adapted to the Portuguese population. The Advance Directives theme wasn't approached during this conference.
16402143|NCT05089409|Drug|ATB1651, 10 mg/mL|The participants will apply daily doses of ATB1651, 10 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
16401998|NCT05090501|Behavioral|Indoor High Intensity Circuit Training|In a windowless room, the participants will execute a 12-exercise High Intensity Circuit Training protocol. Each exercise will have an active part taking 60 seconds, in which exercisers are encouraged to do as many repetitions as possible, and a resting part taking 30 seconds in which the participants rest and are informed of the next exercise. Before and after the 12-exercise routine, the participants rate their affect, arousal and perceived exertion, while using a heart rate monitor and two IMU sensors on their arms and legs.
16401999|NCT05090488|Behavioral|Personal Health Coaching and Diabetes Education in Group|Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care
16402000|NCT05090475|Behavioral|Educational outreach intervention|Educational outreach or academic detailing is a method based on scientific data with the help of educated A-team members in the form of direct (face-to-face) interactions, prescribing practices change and adherence improves according to the application of currently valid therapeutic guidelines
16402001|NCT05090462|Device|PICO dressing|Negative Pressure Wound Therapy device
16402002|NCT05090449|Drug|Chlorthalidone (HIGROTON® 50)|Tablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V.
16402003|NCT05090449|Drug|Losartan (COZZAR®)|Losartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V.
16402004|NCT05090449|Drug|A1+ A2 Co-administration of Chlorthalidone and Losartan|50mg chlorthalidone + 100 mg losartan potassium
16402005|NCT05090449|Drug|Chlorthalidone + Losartan Fixed-Dose combination|Tablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium
16402006|NCT05090436|Other|Schroth Exercise and Functional Electrical Stimulation (physiotherapy techniques)|two month (three session per week)
16402007|NCT05090423|Other|balance training alone|"The subjects will warm up to stretch the lower extremity for 5 minutes.
~The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.
~At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.
~Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller."
16402008|NCT05090423|Other|balance training and neurodynamic intervention for the common peroneal nerve|"The physical therapist will give the patient neurodynamic intervention for the common peroneal nerve, which is performed slider the nerve 2 seconds.
~The slider technique is repeated 30 seconds for 4 times, each time can be take a rest 1 minutes.
~The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.
~At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.
~Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller."
16402009|NCT05090410|Drug|filgotinib 200mg/day|Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX ± other csDMARDs throughout the study period.
16402010|NCT05090410|Drug|subcutaneous tocilizumab 162mg/biweekly|Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX ± other csDMARDs throughout the study period.
16402011|NCT05090397|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
16402012|NCT05090397|Device|Sham Transcranial Direct Current Stimulation|Sham Transcranial Direct Current Stimulation
16402013|NCT05090384|Drug|Prednisone|Prednisone starting dose of 0.5 mg/kg; for patients who respond clinically and continue to have low biomarkers will be tapered rapidly; those that are not clinically responding or whose biomarkers increase will be treated per their treating physicians plan or by standard of care
16402014|NCT05090371|Drug|Ofatumumab|3 loading doses followed by administration every 4 weeks as per label
16402015|NCT05090371|Drug|Disease modifying treatment (DMT)|Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
16402016|NCT05090358|Dietary Supplement|Ketogenic Diet|Properly formulated meals will be provided to both diet groups for the first 12 weeks to facilitate compliance in women with metastatic breast cancer prescribed alpelisib. After 12 weeks, subjects on the two dietary arms will be given the option to cross-over to the other diet arm and continue the prescribed dietary formulation. The decision to cross over will be per patient preference.
16402017|NCT05090358|Dietary Supplement|Low Carbohydrate Diet|Properly formulated meals will be provided to both diet groups for the first 12 weeks to facilitate compliance in women with metastatic breast cancer prescribed alpelisib. After 12 weeks, subjects on the two dietary arms will be given the option to cross-over to the other diet arm and continue the prescribed dietary formulation. The decision to cross over will be per patient preference.
16402018|NCT05090358|Drug|Alpelisib|The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food. Patients should take their dose of PIQRAY at approximately the same time each day.
16402019|NCT05090358|Drug|Fulvestrant|"The recommended dose is 500 mg to be administered intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days
~1, 15, 29 and once monthly thereafter."
16402020|NCT05090358|Drug|Canagliflozin|Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. For the first week of canagliflozin dosing, the dose will be 100 mg. Starting week 2 and onward the dose will be 300 mg and supplied by the site.
16402021|NCT05090345|Other|Biorepository Trial|participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.
16402022|NCT05090332|Other|Facial Gun|Vibration massage applied for five Minutes directly on the trigger point
16402023|NCT05090332|Other|Dry Needling|For dry needling the outer skin should be clean with alcohol and the taut band should be placed between thumb and index finger. Without damaging any nerve or artery the needle is passed though the muscle into the trigger point and breaking it to relief pain
16402024|NCT05090319|Diagnostic Test|complete blood count|Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.
16402025|NCT05090306|Diagnostic Test|Routine ultrasound examination|ULTRASOUND EXAMINATION Women recruited to take part in the study will undergo the routine ultrasound examinations and monitoring, including a fetal echocardiogram between 12-13+6 weeks of gestation (for the first trimester cases) and between 18-24 weeks of gestation (for the second trimester cases). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. The examination will be stored for further analysis.
16402026|NCT05090293|Behavioral|Experimental: Lifestyle Intervention with Body Image Treatment (LIBI)|A body image protocol designed to improve outcomes in a group-delivered multidisciplinary weight loss program by addressing body acceptance within a context of positive behavior change and utilizing existing body discomfort and re-purposing it as an agent of motivation.
16402027|NCT05090293|Behavioral|Lifestyle Intervention (LI)|A multidisciplinary, group-delivered, multidisciplinary weight loss program addressing various lifestyle factors impacting weight loss.
16402031|NCT05090267|Dietary Supplement|Probiotic Supplement|Participants will take a probiotic supplement or placebo for 90 days.
16402032|NCT05090267|Device|Transcutaneous Vagal Nerve Stimulation (tVNS)|Participants will use a non-invasive stimulator 1 hour daily for 30 days. This stimulator is placed around the ear similar to headphones and produces a very mile electric current. This wellness device is safe to use and painless. Some describe the sensation to be a slight tingle up to a small itch.
16402033|NCT05090254|Other|Treatment algorithms targeting cardiac output|Treatment algorithms targeting maximization or personalization of cardiac output
16402034|NCT05090241|Diagnostic Test|Instrumental measurement of balance and gait|The balance measurement was performed on a force platform. The walk test was carried out using sensors to analyze and retrieve data from the participant's walk (gait speed, step length, duration of the double support phase).
16402035|NCT05090215|Behavioral|Aerobic and resistance training 12 week exercise programme|See arm/group description
16402036|NCT05090215|Diagnostic Test|Venous blood sampling|full blood count, urea & electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.
16402037|NCT05090215|Diagnostic Test|Muscle Ultrasound|Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)
16402038|NCT05090215|Diagnostic Test|Cardiopulmonary exercise testing (CPET)|The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET
16402039|NCT05090215|Behavioral|Quality of life questionnaire completion|The use of validated questionnaires to assess quality of life parameters; Duke Activity Status Index (DASI), EORTC-QLQ C30 (quality of life for cancer patients) and the International Physical Activity Questionnaire (IPAQ).
16402040|NCT05090202|Diagnostic Test|hbA1C|hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic
16402041|NCT05090189|Other|Exercise Training|"The present intervention will consist of a 6-month long, twice-weekly, home-based, monitored exercise training program, with training sessions lasting around 40 minutes, with 48 sessions in total. The program will be delivered in the form of 6 x 4-week blocks, which will progressively increase in intensity and complexity, as the participants physical capacities develop. Additionally, and in addition with current physical activity guidelines, participants will be instructed to perform at least an additional 70 minutes of purposeful activities per week. Study trainers will discuss the content of these activities with each individual participant to facilitate selection of suitable activities (e.g., brisk walking, jogging, stair climbing or bike riding), but their selection will be left to the discretion of the individual participants, and activity logs will be maintained throughout the study period."
16402042|NCT05090176|Other|povidone-soaked suture|suture soak with povidone solution for 3 mins
16402043|NCT05090176|Other|ordinary suture|suture no need to soak with povidone solution
16402044|NCT05090163|Other|PREP Plus|Group based exercise in addition to PREP exercises
16402045|NCT05090163|Other|PREP|Group based exercise
16402046|NCT05090150|Other|Home delivery of ART|Home ART refill and monitoring, adherence support
16402047|NCT05090150|Other|Smart Lockers (Pele boxes)|Decentralized ART refills and monitoring, adherence support
16402048|NCT05090150|Other|Best clinic practices + conditional lottery incentives|Conditional lottery incentives Welcome back service (friendly providers, SMS, adherence support) Fast-track ART
16402049|NCT05090150|Other|Best clinic practices|Continue with best clinic practices
16402050|NCT05090137|Other|Diuretics|As per group descriptions
16402051|NCT05090124|Drug|Adalimumab|Adalimumab 40mg, will be administered as a subcutaneous injection once fortnightly on four occasions. The actual Adalimumab product selected at site will be dictated by what is used in standard care.
16402052|NCT05090124|Drug|Placebo|Sodium chloride 0.9% for injection will be used as a placebo. An equal volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection once fortnightly on four occasions.
16402060|NCT05090072|Behavioral|Intervention|The palliative care physician engaged patients and their caregivers in an open discussion about patients' answers to the Advance Directives document, to explore and clarify all doubts and questions prompted by the document
16402062|NCT05090059|Device|Lower limb myofascial trigger points f-ESWT|3 weekly sessions of focused Extracorporeal Shockwave treatment with a frequency of 5 Hz, an energy flux density of 0.05-0.167 mJ(millijoule)/mm2, administered on 3-4 myofascial lower limb trigger points (identified according to the approach of Fascial Manipulation), 1500 shocks per point.
16402063|NCT05090046|Other|Trauma exposure|Exposure to the Canterbury earthquake sequence and other relevant psychological trauma
16402064|NCT05090033|Other|ofatumumab|There is no treatment allocation. Patients administered ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
16402065|NCT05090020|Procedure|Treatment|Surgery and PAIR
16402066|NCT05090007|Device|magnetic resonance image|Imaging data were collected in a strong magnetic field
16402067|NCT05090007|Other|gut microbiota|gut microbiota
16402068|NCT05089994|Procedure|US guided injection|using 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum.
16402069|NCT05089981|Drug|N acetyl cysteine|Intravenous use of N acetyl cysteine in prescribed doses
16402070|NCT05089981|Drug|Placebo of N acetyl cysteine|Intravenous Placebo of N Acetyl cysteine in look alike form (Normal saline)
16402071|NCT05089955|Behavioral|Ambient Experience|MRI examination with Ambient Experience
16402072|NCT05089942|Drug|Recombinant Human Insulin Patch ZJSRM2021|health subjects receive recombinant human insulin patch ZJSRM2021 or placebo patch，diabetic patients receive recombinant human insulin patch ZJSRM2021（low-dosage or high dosage）
16402073|NCT05089929|Device|Endoflip 2.0|FLIP topography (Endoflip 2.0) analysis will be performed on all patients undergoing routine evaluation for gastroesophageal reflux disease at the time of their pre-operative EGD.
16402074|NCT05089929|Procedure|High Resolution Manometry|All patients undergoing routine evaluation for gastroesophageal reflux disease will undergo high resolution manometry (HRM) testing.
16402075|NCT05089916|Drug|Osimertinib|Osimertinib: according to its marketing authorization, i.e. at daily doses of 80 mg, for a maximum of 12 months within the study.
16402076|NCT05089916|Radiation|Radiotherapy|"Radiotherapy: according to standard of care
~The target population will comprise 3 parallel cohorts, for each of which a minimum of 10 subjects is planned to be enrolled:
~Irradiation of bone, solid organ (non-lung, non-brain) or soft-tissue metastases
~Irradiation of brain metastases (initial lesion size < 3 cm)
~Irradiation of lung lesions (primary tumor or metastases, lesion size < 5 cm)"
16402077|NCT05089903|Behavioral|Bulk Order|A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.
16402078|NCT05089903|Behavioral|Texting|In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.
16402079|NCT05089903|Behavioral|Clinician Endorsement|Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.
16402080|NCT05089903|Behavioral|No Bulk Order|The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.
16402081|NCT05089903|Behavioral|Standard Endorsement|Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.
16402082|NCT05089890|Device|Sorbact® Compress|"Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Compress has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds.
~The purpose of the study is not to compare between the devices, but to study each device on its own."
16402083|NCT05089890|Device|Sorbact® Gel Dressing|"Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Gel Dressing has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds.
~The purpose of the study is not to compare between the devices, but to study each device on its own."
16402084|NCT05089890|Device|Sorbact® Ribbon Gauze|"Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Ribbon Gauze has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds.
~The purpose of the study is not to compare between the devices, but to study each device on its own."
16402085|NCT05089877|Device|Surgical Ablation|The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
16402086|NCT05089864|Other|Stent Placement Timing - Early|Stent placement 5-7 weeks after STAR procedure
16402087|NCT05089864|Other|Stent Placement Timing - Late|Stent placement 12-14 weeks after STAR procedure
16402092|NCT05089838|Biological|CMV-TCR-T cells|Patients who developed refractory CMV infection after allo-HSCT will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.3-1×10E7CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).
16402093|NCT05089825|Other|Receive routine instructions|Study subjects randomized to this arm will receive a mailed myLab Box kit with instructions on HPV self-collection and postage to be shipped directly to the commercial lab. It should take less than 5 minutes to collect the sample.
16402094|NCT05089825|Other|Telehealth-based instructional visit and receive routine instructions|"Study subjects randomized to this arm will similarly receive a mailed myLab Box kit and also undergo a brief 5-10 telehealth instructional visit via video conference."
16402095|NCT05089812|Procedure|Third-molar extraction using platelet-rich fibrin as a filling of the alveolus|see above
16402142|NCT05089409|Drug|ATB1651, 5 mg/mL|The participants will apply daily doses of ATB1651, 5 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
16402098|NCT05089773|Procedure|The arterial switch operation|"The ASO is a procedure that emerged as an anatomically as well as physiologically appropriate solution to the transposition of the great arteries. The aorta and pulmonary artery are detached from their native roots and reattached to the opposite root; thus, the pulmonary root becomes the neo-aorta, and the aortic root becomes the neo-pulmonary artery.
~The coronary arteries are transplanted from the aorta/neo-pulmonary artery to the pulmonary artery/neo-aorta."
16402099|NCT05089760|Other|No intervention|This is a prospective observational cohort study. The purpose of the study was to compare the incidence of mortality, complications, and other outcomes between infants with multi-resistant bacteria sepsis and infants with sepsis caused by non-multi-resistant bacteria, and compare the incidence of complications and other outcomes between infants with sepsis-related death and infants who survive.
16402100|NCT05089747|Biological|Blood sampling for biomarker analysis (microRNA, circulating DNA…)|From one to four blood samplings: at diagnosis, after the first cycle of treatment, end of treatment, progressive disease (or end of study).
16402101|NCT05089734|Drug|Sacituzumab Govitecan-hziy (SG)|Administered intravenously
16402102|NCT05089734|Drug|Docetaxel|Administered intravenously
16402103|NCT05089708|Drug|Trifarotene Cream|Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks
16402104|NCT05089708|Drug|Trifarotene Vehicle Cream|Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
16402105|NCT05089695|Device|Noninvasive respiratory support|Treatment of acute hypoxemic respiratory failure
16402106|NCT05089682|Device|DBS Stimulation during sleep|Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
16402107|NCT05089669|Other|Interactive e-book|The nasogastric tube feeding interactive e-book has a lot of elements such as text content, videos, pictures, links, and other interactive content with which the students can interact. The participants can use the interactive e-book to learn nasogastric tube feeding.
16402108|NCT05089669|Other|paper textbook|The paper textbook has text content and pictures. The participants can use the paper textbook to learn nasogastric tube feeding.
16402111|NCT05089643|Drug|Anlotinib；Capecitabine|"Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill.
~Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable."
16402112|NCT05089630|Biological|Pentamer (low)/gB(low)/Adjuvant vaccine|Three doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
16402113|NCT05089630|Biological|Pentamer (med)/gB(low)/Adjuvant vaccine|Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
16402114|NCT05089630|Biological|Pentamer (med)/gB(med)/Adjuvant vaccine|Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
16402115|NCT05089630|Biological|Pentamer (high)/gB(med)/Adjuvant vaccine|Three doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
16402116|NCT05089630|Drug|Placebo (saline)|Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
16402117|NCT05089617|Drug|YG1699|"YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM.
~Drug: Placebo
~Placebo is the same appearance as YG1699."
16402118|NCT05089604|Drug|Tacrolimus, Immediate Release, Oral|Twice Daily Tacrolimus
16402119|NCT05089604|Drug|Tacrolimus Extended Release Oral Tablet|Once Daily Tacrolimus
16402120|NCT05089591|Device|Intense Pulsed Light therapy|The LacryStim System is a CE marked device for treatment of meibomian gland dysfunction. It stimulates and reactivates meibomian glands and improves the related dry eye condition. Intense pulsed light is emitted with a light spectrum from 610nm to 1200nm. Each treatment consists of short individual pulses lasting for 4ms separated by a 26ms lasting interval to hinder tissue temperature increase, thermal damage to the skin and inflammatory reaction. During this phase 8 to 12 J / cm2 are delivered. Selection of total energy levels depends on the skin type (Fitzpatrick Skin Types) as recommended by the manufacturer.
16402279|NCT05075577|Drug|Enzalutamide|Daily oral dose of enzalutamide
16402121|NCT05089591|Device|Sham Treatment|The fellow eye serves as the control eye. Study eye receives the standard energy dose as recommended by the manufacturer (between 8 and 12J/cm2, in accordance with the manufacturer's recommendations). The control eye is treated using low energy dose energy (1J/ cm2) as sham treatment, ensuring blinding of the respective patient.
16402122|NCT05089578|Other|focus interview|"The Information Form including descriptive characteristics of the individuals undergoing Covid-19, the semi-structured Interview Form, and the Complementary Therapy Use Form were used as the data collection tools. The Information Form consisted of 13 questions including socio-demographic and disease-related characteristics of individuals. In-depth interview method was used to collect data. Interviews were held by organizing video calls and online meeting programs on mobile phones both due to pandemic measures and in order to enable individuals to communicate comfortably. The time period in which the individuals felt most ready for the interview was determined and the data were collected during that time. During the interview, effective communication techniques were used, active listening was carried out and individuals were guided using question forms in accordance with the aim of the study. The interviews lasted for an average of 25-30 minutes."
16402123|NCT05089565|Diagnostic Test|Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation|Measurement of humeral and cell-mediated immune responses to SARS-CoV-2 vaccination
16402124|NCT05089552|Other|1-WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale|WHOQOL-BREF(WHO-Quality of life-BREFF) Arabic version Scale The WHOQOL-BREF is composed of 26 self-administered items. Using a 5-point Likert response scale ranging from 1 (very dissatisfied/very poor) to 5 (very satisfied/very good), family caregivers were asked to rank each item accordingly. Caregivers were asked to respond to the items indicating their assessment of QOL during the preceding 2 weeks, Ohaeri and Awadalla developed and tested the Arabic version of the WHOQOL-BREF among an Arab population in Kuwait. The translated Arabic WHOQOL-BREF has considerable reliability and validity indices . As reported in the Kuwaiti study, a satisfactory (≥0.7) Cronbach's alpha was reported for the full questionnaire and the domains
16402125|NCT05089552|Other|SCL-90-R(Symptoms Checklist-90-Revised) Arabic version scale|"developed by Derogatis et al. and El-Behairy. established the validity and reliability of the Arabic version.SCL-90-R is a 90-item self-report symptom inventory, and reflect the psychologic symptom pattern of psychiatric and medical patients. Each item of the 90 is rated on a five-point scale of distress (0-4), ranging from not at all to extremely.Under usual circumstances, SCL-90-R requires between 12 and 15 min to be completed.SCL-90-R is a measure of the current psychologic symptom status. It is not a measure of personality, except indirectly, in that certain personality disorders may manifest a characteristic profile on the primary symptom dimensions."
16402126|NCT05089552|Other|addiction severity index|a semi-structured interview that takes approximately 45 min. developed to evaluate treatment outcome in substance abusers. The instrument focuses on seven areas that are typically affected in the lives of substance abusers: medical status, employment, drug use, alcohol use, legal status, family/social status, and psychiatric status. Information regarding frequency, duration, and severity of problems in these seven areas is collected for both lifetime and recent (past 30 days) history. The ASI provides two types of scores: severity and subjective ratings of the client's need for treatment, and composite scores of problem severity during the prior 30 days. Specific alcohol-related questions include total lifetime years of use, money spent on alcohol, and number of days that alcohol problems are experienced.
16402127|NCT05089539|Drug|Angiotensin Receptor-Neprilysin Inhibition|Sacubitril/valsartan [100 mg] bid). Continuous treatment was maintained for at least three months.
16402128|NCT05089539|Drug|Placebo|Placebo [100 mg] bid). Continuous treatment was maintained for at least three months.
16402131|NCT05089513|Procedure|Robotic surgery|Robotoc surgery (Da Vinci) in both donor and recipient
16402132|NCT05089500|Other|Endoscopic injection sclerotherapy|Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.
16402133|NCT05089500|Other|Endoscopic Band Ligation|Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.
16402134|NCT05089487|Procedure|Nocturnal rest (sleep study)|Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .
16402135|NCT05089474|Device|Streamline Surgical System|The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
16402136|NCT05089461|Drug|Mitoxantrone Hydrochloride Liposome|Mitoxantrone Hydrochloride Liposome, intravenous injection (IV), 20 mg/m^2. Solid tumors: every 3 weeks (q3w, 1 cycle), Lymphoma: every 4 weeks (q4w, 1 cycle).
16402137|NCT05089448|Drug|Alisartan, Amlodipine besylate|Drugs will be taken once daily at 6:00-10:00.
16402138|NCT05089448|Drug|Alisartan, Amlodipine besylate|Drugs will be taken once daily at 20:00-24:00.
16402139|NCT05089435|Device|EZYPRO® ECG Recorder|EZYPRO is an ECG monitoring patch designed to enhance the arrhythmia detection rate by applying 14 days in a home setting environment.
16402140|NCT05089422|Procedure|Squint surgery|Lateral rectus recession and /or medial rectus resection
16402141|NCT05089409|Drug|ATB1651, 2 mg/mL|The participants will apply daily doses of ATB1651, 2 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
16402145|NCT05089396|Other|Maxillary protraction|A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. in the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. in both groups, a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.
16402146|NCT05089383|Drug|Utrogestan|PROSPECTIVE STUDY
16402148|NCT05089344|Drug|Growth Hormone|growth hormone
16402149|NCT05089344|Drug|Clomiphene citrate daily and recombinant FSH (Gonal-F®)|Clomiphene citrate daily and recombinant FSH (Gonal-F®)
16402150|NCT05089318|Dietary Supplement|Flexofytol PLUS|2 tablets in the morning and in the evening for minimum 6 weeks.
16402152|NCT05089292|Behavioral|Narrative breast health education|Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community
16402153|NCT05089279|Drug|D113|QD, PO
16402154|NCT05089279|Drug|CKD-349|QD, PO
16402155|NCT05089266|Drug|CAR T cells|αPD1-MSLN-CAR T Cells
16402156|NCT05089253|Other|Dry Needling|The subject will be in the supine position and received dry needling(30). The first point will be at medial femoral condyle of knee joint line in vastus medialis muscles. The second point will be at lateral femoral condyle of knee joint line in vastus lateralis muscles. The third point will be above base of patella in the rectus femoris muscle. The fourth point will be 2cm above third point in rectus femoris muscles. These four points were the most common places of trigger point at quadriceps muscles. Dry needling is effected on A-delta fibers. Therefore when superficial dry neelding with a noxious stimulation leads to stimulation on A-delta fibers, the excitation remains almost 72 hours and gradually decreases(25).
16402157|NCT05089253|Other|Kinesio tapping|The subject will be in the supine position and received kinesio taping. The Kinesio tape application with no tension one Y strip with a length of 20 cm, an anchor of 2 cm The one end which will be not made a slit, of kinesio tape will be applied to upper thigh. Kinesio tape will be peeled from the release paper and tape will be put there temporarily.
16402158|NCT05089240|Device|Ophthalmic lens with extra power|
16402159|NCT05089227|Drug|"treatment intervention"|for a total of 12 weeks, prophylactic heparin therapy during hospitalization followed by prophylactic oral anticoagulation with apixaban
16402160|NCT05089227|Drug|"treatment standard"|during hospitalization prophylactic heparin therapy followed by management without prophylactic anticoagulation.
16402161|NCT05089227|Biological|biological assessment|CBC, reticulocytes, haptoglobin, LDH, bilirubin
16402162|NCT05089214|Device|Intra oral cameras|Diagnostic comparison of two intra oral cameras
16402163|NCT05089201|Behavioral|Animal-assisted interaction|A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay
16402164|NCT05089201|Behavioral|Conversational control|A handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay
16402165|NCT05089188|Other|Immunomarkers|immunohistochemical expression profile of ambiguous melanocytic proliferation.
16402166|NCT05089175|Drug|Low-dose aspirin|FIGO adopts and supports that in high-risk women, defined by the first-trimester combined test, aspirin ~150 mg/night should be commenced at 11-14+6 weeks of gestation until either 36 weeks of gestation, when delivery occurs, or when pre-eclampsia is diagnosed.
16402167|NCT05089162|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion (including the EVEREST score) will be performed during day hospitalization
16402168|NCT05089162|Procedure|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional
16402169|NCT05089162|Procedure|Blood sample retrieved for biological assessment and biobanking|Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization
16402170|NCT05089162|Other|Telephone follow-up|Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization
16402171|NCT05089149|Procedure|Clinical examination centered on congestion|Clinical examination (including the EVEREST score) centered on congestion will be performed during the day hospitalization
16402172|NCT05089149|Procedure|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional
16402173|NCT05089149|Procedure|Blood sample retrieved for biological assessment and biobanking|Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization
16402174|NCT05089149|Other|Telephone follow-up|Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization
16402273|NCT05077540|Drug|misoprostol|800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
16402280|NCT05075577|Drug|EPI-7386 with Enzalutamide|Daily oral dose of EPI-7386 in combination of enzalutamide
16402175|NCT05089136|Device|transcatheter paravalvular leak closure|Transcatheter paravalvular leak closure (PVLc) was first described in 1992 and has since then emerged as an attractive alternative to repeat surgery. Many implantable devices that can be used for transcatheter PVLc have been marketed, although few are specifically designed for this purpose. It consist in implanting an occluder in the paravalvular leak to stop or reduce the regurgitant flow.
16402176|NCT05089123|Biological|Flu-M [Inactivated split influenza vaccine]|solution for intramuscular injection, 0.5 ml
16402177|NCT05089123|Biological|Inactivated Split Influenza Vaccine|solution for intramuscular injection, 0.5 ml
16402179|NCT05089097|Other|evaluation of delirium with CAM-ICU Score|the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject
16402180|NCT05089084|Drug|ARO-APOC3|ARO-APOC3 injection
16402181|NCT05089084|Drug|Placebo|sterile normal saline (0.9% NaCl)
16402182|NCT05089071|Device|Assist by artificial intelligence system for colon polyp detection|Assist by artificial intelligence system for colon polyp detection
16402183|NCT05089058|Behavioral|Brief, digitally delivered imagery-competing task intervention package, comprised of:|"Two sessions guided (remotely) by a researcher. Sessions comprised of:
~(i) task procedure: a memory cue followed by playing imagery-competing computer game task with mental rotation instructions. Monitoring of intrusive memories to select hotspot cue, and which intrusion to target.
~(ii) accompanying information, including rationale for the brief cognitive task.
~(iii) option to use the brief cognitive task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher."
16402184|NCT05089058|Behavioral|Brief, digitally delivered relaxation task intervention, comprised of:|"Brief, digitally delivered relaxation task intervention, comprised of:
~Two sessions guided (remotely) by a researcher. Sessions comprised of:
~(i) relaxation exercise task using instruction components from progressive muscle relaxation
~(ii) accompanying information, including rationale for the brief relaxation exercise task.
~(iii) option to use the brief relaxation exercise task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher."
16402185|NCT05089045|Biological|Recombinant new coronavirus vaccine (CHO cell) group|Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
16402186|NCT05089019|Drug|Selpercatinib|Administered orally
16402187|NCT05089006|Procedure|Partial nephrectomy with robot-assisted and open surgery|Robot-assisted partial nephrectomy (RAPN) is considered as a feasible minimally invasive alternative to open partial nephrectomy (OPN) for the surgical treatment of renal tumors. The main advantages of this technique include a three-dimensional magnified view of the surgical field, enhanced dexterity, and greater precision in both dissection and reconstruction.
16402188|NCT05088993|Other|Antigravity treadmill training|This group received antigravity treadmill training 100% weight bearing
16402189|NCT05088993|Other|Conventional exercise program|This group received the conventional exercise program only.
16402190|NCT05088980|Device|VOLBELLA with Lidocaine|Facial Injection
16402191|NCT05088967|Drug|IBI110|R2PD d1 IV every 3 weeks
16402192|NCT05088967|Drug|sintilimab|200mg d1 IV every 3 weeks
16402193|NCT05088954|Procedure|transforaminal epidural steroid injection|In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.
16402195|NCT05088915|Behavioral|BREATHE Primary Care Intervention for PTSD (PCIP)|"This program is adapted from the B.R.E.A.T.H.E. - Brief Relaxation, Education and Trauma Healing: A Brief Intervention for Persons with PTSD and Co- Occurring Serious Mental Health Conditions. Treatment Program Manual and Patient Handouts (Version 3) by Kim T. Mueser, Rachael Fite, Stanley D. Rosenberg, and Jennifer D. Gottlieb."
16402196|NCT05088915|Behavioral|Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)|"Nine TF-CBT components exist which are summarized by the acronym PRACTICE.  These components are contained within three phases that are typically provided in equal length. Three phases exist as follows:
~Phase 1: Stabilization Skills Phase 2: Trauma Narration and Processing Phase 3: Consolidation
~Conjoint child-parent sessions to enhance communication about the child's trauma experiences and general parent-child communication
~Enhancing safety and future development to address these issues. During each TF-CBT session, the therapist meets for about half of the session with the child and about half of the session with the parent or caregiver (during the conjoint sessions, most of the session is spent with the child and parent together)."
16402197|NCT05088915|Behavioral|Treatment As Usual|Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.
16402198|NCT05088902|Diagnostic Test|TERABio Ltd.|Covid- 19 investigational breath test compared to RT- PCR test. TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19 ).
16402199|NCT05088889|Drug|Nivolumab|Nivolumab administered IV over 30 minutes at a dose of 360mg every 3 weeks
16402200|NCT05088889|Drug|ipilimumab|Ipilimumab administered IV over 30 minutes at 1 mg/kg every 6 weeks
16402201|NCT05088889|Radiation|Stereotactic body radiation therapy|Three fractions of 8 Gy, treated on alternate days
16402202|NCT05088889|Radiation|Low dose irradiation|a single fraction of 2Gy will be given to the metastatic lesions at first progression
16402203|NCT05088876|Drug|Placebo|Blinded withdrawal of regular co-medication with paracetamol
16402204|NCT05088876|Drug|Paracetamol|Paracetamol in the dose already used
16402205|NCT05088863|Other|flaxseed|40g of flaxseed per day
16402206|NCT05088850|Other|no intervention|no intervention
16402207|NCT05088837|Other|muscle energy technique|MET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles. the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions.
16402208|NCT05088837|Other|ice and heat packs|Applying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions
16402281|NCT05075083|Biological|Inactivated COVID-19 vaccine|receive two doses inactivated COVID-19 vaccine with the interval of 21 days
16402209|NCT05088824|Procedure|hernia repair by desarda technique|It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia
16402210|NCT05088811|Diagnostic Test|WRAP53, UCA-1|Diagnostic value of UCA-1 and WRAP53 in HCC
16402211|NCT05088798|Drug|18F-Fluoro Dopa PET/MRI Imaging|The purpose of this research study is to provide access to an imaging study of the pancreas that uses 6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET) and assess the accuracy of this 18F-DOPA-PET/MRI test on distinguishing what part of the pancreas is affected in patients with Hyperinsulinism.
16402212|NCT05088785|Drug|FES|[18F]FES PET imaging.
16402213|NCT05088772|Device|Hyperbaric Oxygen Therapy|"Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 air breaks, typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference."
16402214|NCT05088759|Behavioral|Alert|The alert-based CDS will consist of an on-screen electronic dialogue box that will notify the clinician that the patient is at increased risk for cardiovascular events and is not at LDL-C goal according to current evidence-based clinical practice guidelines. The clinician will have the opportunity to proceed to an order template through which ezetimibe or a PCSK9 inhibitor can be prescribed. The clinician could also elect to learn more about current evidence-based clinical practice guideline recommendations for LDL targets. Finally, the clinician could elect to proceed without ordering more intensive lipid-lowering therapy or reading the guidelines but would have to provide a rationale for not prescribing ezetimibe or a PCSK9 inhibitor.
16402215|NCT05088746|Procedure|Non-surgical periodontal therapy|NSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019)
16402216|NCT05088733|Drug|Yang Yin Fu Zheng Jie Du therapy|Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
16402217|NCT05088733|Other|Routine medical care|Routine medical care
16402218|NCT05088720|Drug|misoprostol 800 µg|received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
16402219|NCT05088720|Drug|misoprostol 400 µg|received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
16402220|NCT05088707|Drug|sublingual misoprostol|"All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
~Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception"
16402221|NCT05088707|Drug|vaginal misoprostol|"All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
~Paracetamol, eight hourly, will be provided as analgesic or antipyretic"
16402222|NCT05088694|Behavioral|Peaceful Coexistence|"The Peaceful Coexistence intervention seeks to target important risk and protective factors related to tolerance and acceptance.
~The Anti-Extremism intervention seeks to take the same risk and protective factors covered in the Peaceful Coexistence intervention and have students' psychosocial factors shift their skills and behavior."
16402223|NCT05088681|Other|Rehabilitation program|The exercise intervention will consist of an individualized prescription of resistance training, balance training and cardiovascular exercises delivered for 20 session, one-hour, two/three times per week.
16402224|NCT05088668|Other|Augmented reality|"The subjects will perform scapular repositioning exercise using glasses of augmented reality to see their scapular movement simultaneously. Furthermore, they will also see at the same time a video record of an ideal scapular movement, and will me encouraged to simulate that ideal scapular movement."
16402225|NCT05088668|Other|Scapular repositioning exercise|Subjects will perform scapular repositioning exercises for improving scapular movement.
16402226|NCT05088655|Drug|Hetrombopag Olamine Tablet|Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
16402227|NCT05088642|Drug|Hetrombopag Olamine Tablet|Hetrombopag Olamine Tablet
16402228|NCT05088629|Diagnostic Test|Clinical Tests|Clinical Tests
16402229|NCT05088616|Behavioral|Virtual Diabetes Wellness Classes and Medically Tailored Meals|Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.
16402230|NCT05088603|Device|Clear Mask|The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
16402231|NCT05088590|Dietary Supplement|Enfagrow® Neuropro Toddler Nutritional Drink|Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
16402232|NCT05088590|Dietary Supplement|Pediasure® Grow & Gain Protein Shake for Kids|Pediasure® Grow & Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
16402236|NCT05088564|Procedure|Hand-sewn|Doudenojejunal anastomosis by hand-sewn method
16402237|NCT05088564|Procedure|Hemi-double stapling|"Doudenojejunal anastomosis by hemi-double-stapling method EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm is used for anastomosis"
16402274|NCT05077501|Drug|ACD856|Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.
16402275|NCT05077501|Drug|Placebo|Placebo oral solution
16402276|NCT05077423|Drug|CD33*CD3 BsAb|CD33xCD3 is a bispecific monoclonal antibody, which specifically targets CD33 on the AML blasts and CD3 on the T cells
16402277|NCT05077267|Biological|ABNCoV2|IM injection 100ug dose
16402238|NCT05088551|Other|Patient Education|The education was divided into three parts. The information in the first part of the booklet (general information, preoperative preparation, and operation day) is given in the preoperative period. In the postoperative period, the patients were visited and the information in the second part (postoperative hospital stay, first, second, and third-day goals after surgery) was given. Before the patients were discharged, the information in the third section (things to be considered in the recovery process at home) was presented. According to the physical conditions of the clinic, patient education was carried out in an area suitable for teaching as much as possible.
16402239|NCT05088538|Other|Patient Education|After completing the necessary forms, it is planned to give the QR-coded education booklet prepared by the researcher to the patients and to inform the patients and their relatives about the use of QR codes. At that time, it is planned that the teaching will be carried out using various training methods such as lecture, question-answer, demonstration and practice. It is thought that the teaching will be divided into 3 parts: pre-operative, post-operative and discharge. According to the physical conditions of the clinic, it is planned to provide patient education in an suitable area for teaching as much as possible. Patients will be reminded that they can access the information whenever they want and as many times as they want by scanning the QR code from their phone.
16402240|NCT05088525|Procedure|MRI|MRI for standard of care meniscus root repair surgery - noting with an added stabilization suture if it is able to successfully slow down the progression of osteoarthritis versus a standard root repair surgery.
16402241|NCT05088512|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16402242|NCT05088499|Genetic|DNA analysis|GWAS
16402243|NCT05088486|Genetic|DNA analysis|GWAS
16402244|NCT05088473|Other|Biological collection|Collection of cerebrospinal fluid kappa and lambda free light chains and indexes
16402245|NCT05088460|Drug|REGN4461|Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).
16402246|NCT05088460|Drug|Matching Placebo|Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).
16402247|NCT05088434|Dietary Supplement|Anaerobically Cultivated Human Intestinal Microbiota (ACHIM)|One vial of ACHIM suspension (ACHIM Biotherapeutics AB, Vallingby, Sweden), containing 30 x 109 CFU of bacteria, was given through the work channel of a gastroscope into the lower part of duodenum.
16402248|NCT05088434|Dietary Supplement|Donor fecal microbiota transplantation|Only 60 ml of sterile 0.9% normal saline were added to a stool specimen, collected from the respective donor, with a weight of ~30 g and homogenized manually. Then 60 ml of feces-suspension (screened from the patients view) were instilled through the work channel of a gastroscope into the lower part of the duodenum.
16402249|NCT05088434|Dietary Supplement|Placebo|Only 60 ml of sterile 0.9% normal saline were added to the patient's own stool specimen with a weight of ~30 g and homogenized manually. Then 60 ml of feces-suspension (screened from the patients view) were instilled through the work channel of a gastroscope into the lower part of the duodenum.
16402250|NCT05084911|Drug|Pyramax|Pyronaridine-Artesunate(180/60mg) tablet for 3days.
16402251|NCT05084911|Drug|Placebo|Placebo tablet for 3days.
16402252|NCT05084157|Diagnostic Test|Echocardiography|Patients will undergo Doppler echocardiography
16402253|NCT05084118|Drug|Landiolol HCl|continous 2mcg/kg/min low dose application of Landiolol HCl for 72 hours
16402254|NCT05084118|Drug|Placebo|continous application of isotone saline solution for 72 hours
16402255|NCT05081492|Biological|Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody|Given IT
16402256|NCT05081349|Drug|Hydroxycarbamide 500 Mg Oral Capsule+L-Carnitine|Combination therapy
16402257|NCT05081349|Drug|Hydroxycarbamide 500 Mg Oral Capsule|Single agent
16402258|NCT05081349|Drug|L-Carnitine, 250 Mg Oral Capsule|single agent
16402259|NCT05080439|Other|Diacutaneous Fibrolysis|Application of diacutaneous fibrolysis in teres major
16402260|NCT05080439|Other|Dry needling|Dry needling based on fast-in fast-out technique in the teresa major muscle
16402261|NCT05080270|Biological|Tolerogenic Fibroblasts|administrating single dose of 100 million tolerogenic fibroblasts via intravenous infusion
16402262|NCT05079776|Other|Physical length measurement|Physical length will be measured and images will be collected for AI to estimate the length
16402263|NCT05079126|Drug|Trans Sodium Crocetinate|Single IV Bolus
16402264|NCT05079126|Drug|Placebo|Single IV Bolus
16402265|NCT05078931|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30-minute IV infusion every 3 weeks for up to 35 cycles
16402266|NCT05078931|Drug|Lenvatinib|Lenvatinib 20mg will be administered orally daily.
16402268|NCT05078450|Behavioral|Mood Lifters|Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness.
16402269|NCT05078268|Behavioral|HRV biofeedback training and self-help CBT-I|Participants will receive a booklet with content related to both self-help CBT-I and HRV biofeedback per week for 6 consecutive weeks. Participants are required to use around 1 hour to read through the content and perform the HRV biofeedback practice for around 20 minutes a day, 5-7 days a week and record their practice.
16402270|NCT05078268|Behavioral|Self-help CBT-I only|Participants will receive a booklet with content related to self-help CBT-I only per week for 6 consecutive weeks. Participants are required to use 30 to 40 minutes to read through the content.
16402271|NCT05077605|Other|Functional residual capacity measure by electrical impedance tomography|Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.
16402272|NCT05077540|Drug|oxytocin|20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
16402278|NCT05075798|Other|No intervention,|pure observational study
16402282|NCT05075070|Biological|Inactivated COVID-19 vaccine|two doses inactivated COVID-19 vaccine
16402283|NCT05075057|Biological|Inactivated COVID-19 vaccine|three doses of inactivated COVID-19 vaccine
16402284|NCT05075044|Biological|Inactivated COVID-19 vaccine|three doses of inactivated COVID-19 vaccine
16402285|NCT05074420|Drug|Baricitinib|Given Orally
16402286|NCT05073549|Behavioral|Collaborative Antimicrobial Stewardship Program (ASP)|"The collaborative ASP interventions will be implemented from October 1st, 2021 to September 30th, 2023 in all participating NICUs.
~The collaborative ASP interventions include two levels of interventions that will be delivered at the NICU level: the NICU-targeted ASP program and collaborative quality improvement interventions to facilitate implementation of the ASP.
~The core elements of the NICU-targeted ASP program include the establishment of ú ASP leader and team, development of the facility-specific antibiotic guidelines, checklist-led audit and feedback, and staff education.
~The collaborative quality improvement interventions include data feedback and benchmarking, a potential 'better practice' list on neonatal antibiotic use, implementation using Plan-Do-Study-Act cycles and collaborative learning."
16402287|NCT05073510|Device|BVE|Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)
16402288|NCT05072639|Behavioral|Guided Meditation|23 minute audio recording
16402289|NCT05072444|Drug|QPX7728|beta lactamase inhibitor
16402290|NCT05072444|Drug|QPX2014|antibiotic
16402291|NCT05071599|Device|Twin Arch Brackets|Twin Arch Brackets characterized by double horizontal slots which make it capable to accept two arch wire at the same time which in turn can achieve a better control over orthodontic tooth movement
16402292|NCT05068791|Drug|Psilocybin|0.36 mg/kg will be administered orally to participants
16402293|NCT05068791|Drug|Dextromethorphan|2.6 mg/kg of active placebo will be administered orally to participants
16402294|NCT05068089|Procedure|Nissen fundoplication|Nissen fundoplication, numbers, reasons and length of hospitalizations, gastrointestinal symptoms and survival
16402295|NCT05068089|Biological|Enteral nutrition|Type and switch of enteral nutrition formula (tube, PEG, PEJ)
16402296|NCT05064878|Drug|ZX008 (Fenfluramine Hydrochloride)|ZX008 is supplied as an oral aqueous solution of Fenfluramine Hydrochloride.
16402297|NCT05064878|Drug|Matching ZX008 Placebo|Matching ZX008 placebo is supplied as an oral solution.
16402298|NCT05064397|Drug|Eptinezumab|Eptinezumab will be administered per schedule specified in the arm description.
16402299|NCT05064319|Drug|Gabapentin|After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.
16402300|NCT05064319|Drug|Placebo|After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days.
16402301|NCT05063617|Device|SCI Step Together|The 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice to apply the strategies in their own goals for that week along with embedded questions to discuss with their community coach 3) behavioural support from the community coach and 4) peer support from the discussion group.
16402303|NCT05061992|Drug|Lactulose|"Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
~In addition, outcome measurements will be completed at baseline and day 28."
16402304|NCT05059301|Biological|RSVPreF3 OA investigational vaccine|One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.
16402310|NCT05057468|Drug|Cyclosporine|2.5-5 mg orally for 3 months
16402311|NCT05057468|Drug|Rituximab|375 mg/ m2 weekly dose for a maximum of 4 weeks
16402312|NCT05057442|Other|Proprioception assessment, functionality assessment|Proprioception assessment, functionality assessment
16402313|NCT05056766|Behavioral|questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.|"Each patient will undergo 3 to 7 polygraphy recordings according usual practice of titration At the same time, Self-questionnaires will be conducted by the patient in order to evaluate Oral appliance efficacy.
~Optimal titration of oral appliance will be done according subjectives parameters. (sleepeness Reduction and fatigue Reduction).
~Neither the investigator nor the patient will know the polygraphy results (apnea-hypopnea index)"
16402314|NCT05056727|Drug|Sodium Zirconium Cyclosilicate (SZC)|"Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets.
~During Initiation Phase:
~S-K > 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water and administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L)
~S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours.
~During Run-in and Maintenance Phases:
~- Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water."
16402315|NCT05056727|Drug|Placebo|"Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets.
~During Maintenance Phase:
~- Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water."
16402316|NCT05056727|Drug|Lisinopril|Tablet for oral administration. Unit dose strength: 5 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.
16402317|NCT05056727|Drug|Valsartan|Tablet or capsule for oral administration. Unit dose strength: 40 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.
16402318|NCT05056727|Drug|Irbesartan|"Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily.
~The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved."
16402319|NCT05055258|Drug|KVD824|KVD824 300 mg Modified-Release Tablets
16402320|NCT05055258|Drug|Placebo to KVD824|Placebo to KVD824 300 mg Modified-Release Tablets
16402321|NCT05053880|Drug|ACT001|Phase1b - Starting approximately 2 weeks prior to the scheduled surgery, patient will receive an assigned dose of ACT001 by mouth in combination with a single dose of 200 mg pembrolizumab via an intravenous (IV-through a tube in vain) infusion in the clinic. Then patient will self administer ACT001 capsules twice daily by mouth, at the dose to which patient is assigned, until the evening prior to scheduled surgery. Patient will then undergo surgery to remove all or part of tumor. This a standard 3+3 dose escalation.
16402322|NCT05053880|Drug|ACT001 + Pembrolizumab|Phase 2a - Starting approximately 2 weeks prior to the scheduled surgery, patient will receive a single dose of 200 mg pembrolizumab via an intravenous (IV) infusion in the clinic (an IV infusion means the drug will be delivered through a tube in your vein). Patient will then self-administer ACT001 capsules twice daily by mouth, at the dose to which patient is assigned, until the evening prior to scheduled surgery. Patient then will undergo surgery to remove all or part of tumor.
16402323|NCT05052736|Device|Non-invasive Neuromodulation|"The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7.
~Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA."
16402324|NCT05051735|Drug|Paracetamol|Paracetamol 500 mg
16402325|NCT05051735|Drug|Placebo|Placebo
16402328|NCT05048784|Drug|Sotorasib|Oral tablet
16402329|NCT05047601|Drug|PF-07321332|PF-07321332
16402330|NCT05047601|Drug|Placebo for PF-07321332|Placebo
16402331|NCT05047601|Drug|Placebo for Ritonavir|Placebo
16402332|NCT05047601|Drug|Ritonavir|Ritonavir
16402333|NCT05046327|Drug|Avatrombopag 20 mg Oral Tablet|Avatrombopag administered at a frequency to maintain a target platelet count between ≥50 and ≤150×10⁹/L
16402334|NCT05046132|Drug|Setmelanotide|Subcutaneous (SC) setmelanotide: SC injection: 2 mg × 7 days followed by 3, 5, and 7 mg × 3 days per dose level
16402335|NCT05046132|Drug|Moxifloxacin|Moxifloxacin 400 mg capsules for oral administration (active comparator)
16402336|NCT05046132|Drug|Oral Placebo|Placebo capsules for oral administration (identical in appearance to oral moxifloxacin treatment)
16402337|NCT05046132|Drug|SC Placebo|Placebo for SC injection (vehicle only; identical in appearance to SC setmelanotide treatment)
16402338|NCT05045833|Drug|SYN-020 Delayed Release Capsule|Oral administration (by mouth)
16402339|NCT05043077|Drug|Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%|1 drop (6.5 μL) for 3 doses with 5-minute intervals
16402340|NCT05043077|Drug|Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%|1 drop (28-34 μL) for 3 doses with 5-minute intervals
16402341|NCT05036291|Drug|NB004 tablets|NB004 tablets will be administered orally once daily for repeated 28-day cycles until discontinuation criteria are met.
16402342|NCT05035459|Diagnostic Test|lung ultrasound|Impact of residual lung B-lines at discharge on outcome of discharged heart failure patients and impact of intensive heart failure management on discharged HF patients with residual lung B-lines
16402343|NCT05035459|Diagnostic Test|Lung ultrasound|Adding routine lung ultrasound test fro discharged heart failure patients might favor risk stratification of discharged HF patients and intensive heart failure management program on discharged heart failure patients with residual lung B-lines might improve outcome of theses patients up to 1 year after discharge.
16402354|NCT05035225|Other|Survey|Multiple Pharmacy Use Survey
16402355|NCT05033184|Behavioral|Brief Action Planning Exercise|The Brief Action Planning exercise is a previously developed goal-setting exercise which has been designed to incorporate aspects of motivational interviewing such as compassion, acceptance, evocation, and partnership. It is a tool that allows participants to identify an aspect of their life they would like to improve upon and guides them through the process of making a specific, measurable, achievable, realistic, and timely (SMART) goal. It also assesses their confidence in achieving this goal so as to assist with making alternative plans if confidence is low.
16402356|NCT05033184|Behavioral|Goal Setting Exercise|The Goal Setting exercise allows participants to identify an aspect of their life they would like to improve upon without incorporating aspects of motivational interviewing components or providing any guidance on how to set this goal.
16402357|NCT05030454|Device|ETHOS|Ring-gantry CT-guided radiotherapy unit, pairing a linear accelerator within a ring-gantry imaging unit.
16402358|NCT05030454|Radiation|CT-guided stereotactic adaptive radiotherapy|All participants will be initially planned to at least 35 Gy in 5 fractions, subject to hard constraints based on the treatment site.
16402372|NCT05027464|Behavioral|Moving to COVID-19 Vaccine Acceptance Intervention|The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
16402373|NCT05027113|Behavioral|Mindfulness meditation|Participants use the meditation app 10% Happier to practice mindfulness meditation (see detailed description in arm/group section)
16402374|NCT05020587|Behavioral|Open pilot trial of a group therapy manual.|Open pilot trial of a group therapy manual.
16402375|NCT05019963|Behavioral|NexJ Connected Wellness|NexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard.
16402376|NCT05019963|Other|Usual Care|Participants will receive a treatment plan as decided on with their clinician(s).
16402879|NCT04576117|Drug|Selumetinib Sulfate|Given PO
16402387|NCT05013229|Drug|IcoSema|Participants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.
16402388|NCT05013229|Drug|Insulin glargine|Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.
16402389|NCT05013229|Drug|insulin aspart|Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.
16402393|NCT05010304|Drug|Amoxicillin|Two-dose amoxicillin challenge
16402394|NCT05009992|Drug|ONC201|Given orally (PO)
16402395|NCT05009992|Radiation|Radiation Therapy|Undergo radiation therapy
16402396|NCT05009992|Drug|Panobinostat|Given PO
16402397|NCT05009992|Drug|Paxalisib|Given PO
16402402|NCT05008913|Drug|[14C]Adavosertib|Patients will receive a single administration of [14C]Adavosertib as an oral solution on Day 1.
16402403|NCT05007951|Biological|GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)|injection volume of 0.5mL on days 0 and 28
16402404|NCT05007951|Biological|ChAdOx1-S not less than 2.5 × 10^8 infectious units|injection volume of 0.5mL on days 0 and 28
16402408|NCT05003609|Other|Early Rehabilitation|The intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation.
16402409|NCT05002439|Other|Multicomponent physical exercise program and a nutritional intervention|The exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 16 weeks, twice a year. Nutritional intervention will be based on the results of MNA-SF. If the results of this instrument show normal nutrition status, general nutritional recommendations will de presented by a nutritionist twice a year before the physical exercise program. If MNA-SF shows nutritional risk or malnutrition, oral nutritional supplementation will be offered. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm
16402412|NCT04993001|Other|Open lung extubation|Before starting emergence from anesthesia, the patient will be transferred to their hospital bed or stretcher and seated at 30 degrees. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be maintained at the same level or increased to 50% (minimum FiO2) with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilation mode will be changed to pressure support. The level of pressure support will be modified by the anesthesiologist to generate the same volumes as with controlled ventilation. The PEEP will be maintained at the same level. The minimum respiratory rate will be reduced by 4 min-1. The inspiratory flow for triggering will be 2 L.min-1.
16402413|NCT04993001|Other|Conventional extubation|Before starting emergence from anesthesia, the patient will be transferred to his hospital bed or stretcher and kept in the supine position. Secretions from the patients' oropharynx will be suctioned. To prevent the patient from coughing, the anesthetic gas or intravenous agent will be stopped after the transfer and suction procedure are completed. The FiO2 will be increased to 100% with a fresh gas flow rate greater than or equal to 10 L.min-1. The ventilator will be stopped with the APL valve open to atmosphere. The patient will be manually ventilated with the reservoir bag until spontaneous ventilation resumes. Then, the patient may be manually assisted if the treating anesthesiologist deems it necessary.
16402414|NCT04991818|Other|OneBiome microbiome profiling service|participants will be asked to complete the user experience of the OneBiome service
16402448|NCT04962724|Drug|Radiolabelled Xevinapant 100 μg (IV Solution)|100 μg [14C]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi [7.4 kilobecquerel (kBq)].
16402449|NCT04962724|Drug|Xevinapant 200 mg (Oral Solution)|Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions
16402415|NCT04991103|Drug|DaraVRD|"All patients with newly diagnosed multiple myeloma who was enrolled on the study will receive six cycles of combination quadruplet therapy (DaraVRD).
~Six 28-day induction cycles of oral lenalidomide (25 mg daily on days 1-21), subcutaneous bortezomib (1.3 mg/m2 on days 1, 8, 15, 22), subcutaneous daratumumab (1800 mg on days 1, 8, 15, 22 of cycles 1-2 and days 1, 15 for cycles 3-6), and oral dexamethasone (40 mg on days 1, 8, 15, and 22)."
16402416|NCT04989946|Drug|Degarelix|standard Gonadotropin-releasing hormone (GnRH) antagonist
16402417|NCT04989946|Biological|pTVG-AR|DNA vaccine encoding androgen receptor ligand-binding domain
16402418|NCT04989946|Drug|Nivolumab|Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
16402419|NCT04987021|Device|Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants|The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
16402420|NCT04983862|Drug|Illuminare-1|Illuminare-1 at 3 dose levels in patients undergoing minimally invasive radical prostatectomy and bilateral pelvic lymph node dissection. Three dose levels will be used: 0.25mg/kg, 0.5mg/kg, and 1.0mg/kg. Once the imaging dose of Illuminare-1 is established at a no-DLT level, an expansion cohort of 20 patients will be evaluated at this dose.
16402421|NCT04983862|Device|Karl Storz D-Light C photodynamic diagnostic (PDD)|The Storz PDD system will be used as the hardware system in this phase 1 study due to its proven safety profile.
16402422|NCT04983589|Drug|AGN-190584|Ocular drops
16402423|NCT04983589|Drug|Vehicle|Ocular drops
16402424|NCT04979949|Biological|CoronaVac|Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28
16402425|NCT04979949|Biological|CoronaVac|Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28
16402426|NCT04979312|Device|LabClasp|participants will be randomized to LabClasp + standard care or just standard care
16402427|NCT04978480|Other|no intervention|There is no intervention. We are only collecting standard of care data.
16402428|NCT04978064|Behavioral|e-health psychological counselling|"Intervention group: Women positive for IPV who accept the e-Health intervention and who have been randomly allocated in the intervention group will receive the e-health package as the rest of the cohort, as well as the baseline and outcome measurements. The e-health package will include six video counselling sessions by trained providers and the access to a mobile application for designing security plans, an adapted version of the mobile application My Plan. The content of the six individually tailored sessions will be based on the Dutton's Empowerment Model and the Psychosocial Readiness Model.
~Control group: women positive in IPV who accept the e-Health intervention package will be asked for a second consent to receive a delayed intervention (8 weeks later) and to complete as the baseline and outcome measurements. Women can request to leave the control group at any time and to receive the intervention immediately (in which case they data will be part of the cohort study)."
16402429|NCT04977986|Drug|ZYN002 - CBD transdermal gel|Pharmaceutically manufactured cannabidiol (CBD) formulated as a clear gel that can be applied to the skin (transdermal delivery)
16402430|NCT04977986|Drug|Placebo|"Placebo formulated as a clear gel that can be applied to the skin (transdermal delivery)
~Other Names:
~Placebo Comparator Matching Placebo"
16402431|NCT04976634|Drug|Pembrolizumab|Pembrolizumab 400 mg administered Q6W via IV infusion
16402432|NCT04976634|Drug|Belzutifan|Belzutifan 120 mg administered QD via oral tablet
16402433|NCT04976634|Drug|Lenvatinib|Lenvantinib dose for HCC is 8 mg QD for body weight <60 kg and 12 mg QD for body weight ≥ 60 kg administered via oral capsule. For all other tumors, the lenvatinib dose is 20 mg QD administered via oral capsule
16402434|NCT04976322|Drug|Dapirolizumab pegol|Subjects will receive dapirolizumab pegol at prespecified time-points.
16402435|NCT04969939|Drug|Semaglutide 2.4 mg and NNC0165-1875 2.0 mg|NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
16402436|NCT04969939|Drug|Semaglutide 2.4 mg and placebo 2.0 mg|NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
16402437|NCT04969939|Drug|Semaglutide 2.4 mg and NNC0165-1875 1.0 mg|NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
16402438|NCT04969939|Drug|Semaglutide 2.4 mg and placebo 1.0 mg|NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
16402439|NCT04967612|Other|Virtual implantation|Temporary placement of virtual optical lens in the crystalline lens plane.
16402440|NCT04965675|Drug|Eptinezumab|Eptinezumab will be administered per dose and schedule specified in the arm.
16402441|NCT04965675|Drug|Placebo|Placebo matching to eptinezumab will be administered per schedule specified in the arm.
16402442|NCT04965168|Procedure|phacoemulsification of the lens|all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
16402443|NCT04962867|Drug|E7090|140 mg of E7090 is orally administered once daily.
16402444|NCT04962776|Drug|Low-concentration carbohydrate and nitrates|Patients in the CHON group will be given 400 mL of a clear carbohydrate drink (12.5 g/100 mL maltodextrin, 50 kcal/100 mL) and 2 capsules of beet root extract 1 gm on the evening before surgery (8 hours) and another 200 mL of the carbohydrate drink and 1 capsule of beet root extract 1 gm on the day of surgery, 2 h before anesthesia induction.
16402445|NCT04962776|Drug|Low-concentration carbohydrate|Patients in the CHO group will be given the same carbohydrate drink in the CHON group with 2 placebo capsules with the evening drink and one with the morning drink.
16402446|NCT04962776|Other|Water with placebo capsules|Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.
16402447|NCT04962724|Drug|Radiolabelled Xevinapant 200 mg (Oral Solution)|[14C]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) [3.7 megabecquerel (MBq)] in fasted conditions.
16402450|NCT04962685|Other|Rapid Maxillary Expansion|"Subjects in the experimental group (with unilateral posterior crossbite) will be treated with Maxillary Rapid Expansion using a disjunctor fixed with two bands on the upper first permanent molars and a mesh cemented to the upper first premolars or upper first primary molars (depending on the eruptive stage of the patient).
~The breaker screw will be activated twice a day until a transverse overcorrection of 2 mm is achieved in the first permanent molars. When the active disjunction phase is completed, the screw will be blocked out with light-curing flowable resin and the patient will wear the cemented disjunctor as a retainer for a minimum of six months."
16402451|NCT04961593|Drug|Caspofungin|For children 3 months of age, the recommended dose is 70 mg/m2 for load and then 50 mg/m2 for maintenance, intravenous injection, once daily up to 5 days.
16402452|NCT04961580|Drug|Ceftazidime Avitbatan Sodium|For 6-18 years children, 62.5 mg/kg/once，q8h ; 3-6 months of age 50 mg/kg/ once,q8h, intravenous administration for 2 hours, daily dose is not more than 2.5g, children will be administrated at least five times.
16402453|NCT04961567|Drug|BIIB059|Administered as specified in the treatment arm.
16402454|NCT04961567|Drug|BIIB059-Matching Placebo|Administered as specified in the treatment arm.
16402455|NCT04960709|Drug|Durvalumab|Anti- PD-L1 Antibody
16402456|NCT04960709|Drug|Tremelimumab|Human IgG2 mAb
16402457|NCT04960709|Drug|Enfortumab Vedotin|Nectin-4-directed antibody and microtubule inhibitor conjugate
16402458|NCT04960709|Procedure|Radical Cystectomy|For cisplatin-ineligible patients
16402459|NCT04960397|Other|Placebo|Physiological saline, i.e., 0.9% sodium chloride.
16402460|NCT04960397|Biological|Sing2016 M2SR H3N2|Novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc.
16402464|NCT04958785|Biological|Magrolimab|Administered intravenously
16402465|NCT04958785|Drug|Nab-Paclitaxel|Administered intravenously
16402466|NCT04958785|Drug|Paclitaxel|Administered intravenously
16402474|NCT04956354|Device|ANNE™ Monitoring System (2 sensors)|"ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad tablet application. Study sensors to be applied on patients are:
~Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements.
~Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals."
16402475|NCT04956354|Device|ANNE™ Monitoring System (3 sensors)|"ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad tablet application. Study sensors to be applied on patients are:
~Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements.
~Sensor 2 - An abdominal unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and abdominal wall movements. Only signals of abdominal wall movements will be collected.
~Sensor 3 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals."
16402476|NCT04955210|Other|Not applicable（Cohort study）|This is a prospective observational study and does not include interventions.
16402477|NCT04952389|Device|Acupuncture Therapy|Consists of two treatments per week for five weeks
16402478|NCT04952389|Drug|Budesonide|Twice daily nasal rinses with steroid medication (budesonide)
16402479|NCT04952389|Other|Olfactory Training|involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
16402482|NCT04950166|Drug|pegsitacianine|An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
16402483|NCT04950075|Drug|INBRX-109|Tetravalent DR5 Agonist Antibody
16402484|NCT04950075|Drug|Placebo|Placebo
16402485|NCT04949854|Device|B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter|control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire
16402486|NCT04949854|Device|B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter|Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire
16402487|NCT04949711|Behavioral|ridesharing voucher|Ridesharing vouchers will be given for completing each of the online surveys, for a possible total of $80 if you complete all three surveys. You will be paid with electronic vouchers that will be sent to your cell phone.
16402488|NCT04949711|Behavioral|online shopping voucher|Online shopping vouchers will be given for completing each of the online surveys, for a possible total of $80 if you complete all three surveys. You will be paid with electronic vouchers that will be sent to your cell phone.
16402491|NCT04945213|Drug|Biperiden|5mg of biperiden diluted in 10 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV
16402492|NCT04945213|Other|Placebo|1ml of 0.9% saline diluted in 10 ml 0.9% saline - every 6 hours for 10 consecutive days - IV
16402493|NCT04943926|Other|Energy restricted diet|Nutritional complete formula diet followed by an energy restricted diet
16402494|NCT04943926|Other|Low carbohydrate high fat diet|Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)
16402495|NCT04940624|Drug|Soticlestat|Soticlestat mini-tablets or tablets.
16402496|NCT04940624|Drug|Placebo|Soticlestat placebo-matching mini-tablets or tablets.
16402504|NCT04938427|Drug|Soticlestat|Soticlestat mini-tablets or tablets.
16402505|NCT04938427|Drug|Placebo|Soticlestat placebo-matching mini-tablets or tablets.
16402506|NCT04936230|Biological|Atezolizumab|Given IV
16402507|NCT04936230|Other|Quality-of-Life Assessment|Ancillary studies
16402508|NCT04936230|Other|Questionnaire Administration|Ancillary studies
16402509|NCT04936230|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16402524|NCT04932915|Drug|Niclosamide|Niclosamide is a broad spectrum, host targeting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide solution is administered directly to the nasal cavity via a nasal spray.
16402525|NCT04932915|Drug|Placebo|The placebo formulation contains purified water, sodium chloride as common isotonizing agent and the FAO/WHO approved colorant FD&C Red 40 to match the red-orange colour of the active solution. The solution is administered directly to the nasal cavity via a nasal spray.
16402526|NCT04930705|Device|Treatment with TempSure Applicator|Subjects will receive up to 5 treatments on the abdomen.
16402527|NCT04930328|Drug|Oxbryta® (voxelotor) 500-mg Tablets|Patients will have received treatment with Oxbryta as prescribed by their physician at the approved dose per local prescribing information, as part of their usual care.
16402528|NCT04927975|Drug|Upadacitinib|Oral tablets
16402529|NCT04927975|Drug|Placebo|Oral tablets
16402530|NCT04927780|Drug|Leucovorin Calcium|IV
16402531|NCT04927780|Drug|Fluorouracil|IV
16402532|NCT04927780|Drug|Irinotecan Hydrochloride|IV
16402533|NCT04927780|Drug|Oxaliplatin|IV
16402534|NCT04927780|Procedure|Resection|Open or minimally-invasive pancreatectomy.
16402535|NCT04927572|Drug|FMX114|Active Comparator
16402536|NCT04927572|Other|Vehicle|Placebo Comparator
16402538|NCT04925180|Drug|Cyproterone Acetate (Androcur, BAY94-8367)|As prescribed by the treating physician
16402547|NCT04921384|Drug|Placebo|Placebo - 100 mL of 0.9% normal saline, intravenously
16402548|NCT04921384|Drug|Eptinezumab|Eptinezumab - solution for infusion, intravenously
16402549|NCT04920617|Drug|DPX-Survivac|SC injection on D7 and D28, then every 8 weeks
16402550|NCT04920617|Drug|Pembrolizumab|IV infusion every 3 weeks
16402551|NCT04920617|Drug|CPA|50 mg twice daily, week on then week off
16402552|NCT04919993|Behavioral|Cognitive Behavioral Therapy-Insomnia|Group presentation
16402555|NCT04908592|Drug|Dexamethasone|Patients will receive dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.
16402556|NCT04908592|Other|Placebo|Patients will receive 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.
16402557|NCT04905407|Drug|SY-1425|SY-1425 tablets will be administered per dose and schedule specified in the arm.
16402558|NCT04905407|Drug|Venetoclax|Venetoclax tablets will be administered per dose and schedule specified in the arm.
16402559|NCT04905407|Drug|Azacitidine|Azacitidine injection will be administered per dose and schedule specified in the arm.
16402562|NCT04900844|Device|CGuard Carotid Stent implantation|Implantation of CGuard carotid stent in the eligible patients
16402564|NCT04895930|Drug|Furmonertinib|80mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (40mg).
16402565|NCT04895930|Drug|Anlotinib|10mg/day orally from day 1 to 14 of a 21-day cycle. If subjects suffer from AEs, they can get declined dosage (8mg).
16402573|NCT04895241|Drug|BIIB059|Administered as specified in the treatment arm.
16402574|NCT04895241|Drug|BIIB059 matching placebo|Administered as specified in the treatment arm.
16402575|NCT04895072|Procedure|Erector Spinae Plane Block|Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
16402576|NCT04895072|Procedure|Erector Spinae Plane Block|Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.
16402577|NCT04891770|Drug|Tenofovir Alafenamide|Administered as film-coated oral tablets
16402578|NCT04891770|Drug|VIR-2218|Administered as a sub-cutaneous (SC) injection
16402579|NCT04891770|Drug|Nivolumab|Administered intravenously
16402580|NCT04891770|Drug|Selgantolimod|Administered as film-coated oral tablets
16402581|NCT04890548|Drug|AZD3427|Patients will receive 5 IA infusions of AZD3427 into the brachial artery. The IA infusions of AZD3427 will be administered via a syringe pump, using a polypropylene syringe containing 0.9% (w/v) saline and delivered through an administration set comprising a syringe, extension tubing (PVC), and a 0.2- or 0.22-μm PVDF syringe filter.
16402585|NCT04889417|Behavioral|Comprehensive training program|The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised video conference physical exercise sessions performed 2-4 weeks prior to surgery and for 3 months after discharge.
16402586|NCT04889417|Behavioral|Active control|The active attention control will include control computer games and supervised video conference stretching exercises performed 2-4 weeks prior to surgery and for 3 months after discharge.
16402587|NCT04889209|Biological|Ad26.COV2.S|Formulated to contain 5x10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-ß-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
16402588|NCT04889209|Biological|BNT162b2|A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
16402589|NCT04889209|Biological|mRNA-1273|Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
16402590|NCT04889209|Biological|mRNA-1273.211|Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
16402591|NCT04886856|Behavioral|Mindful Moms|Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.
16402592|NCT04886856|Behavioral|Prenatal Education|Twelve 75 minutes weekly group sessions involving prenatal education (for example, what to expect during your pregnancy, during labor and delivery, and after the delivery of your child).
16402593|NCT04885257|Drug|Methylphenidate|Methylphenidate oral pill. Dosing instructions given to
16402594|NCT04885257|Drug|Placebo|Placebo arm
16402599|NCT04875195|Biological|Pembrolizumab|Pembrolizumab, 400 mg, Q6W, intravenous (IV) infusion.
16402600|NCT04874584|Behavioral|CTNSM|The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy .
16402601|NCT04874584|Behavioral|Standard of Care Chemotherapy Education|Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms.
16402602|NCT04871971|Dietary Supplement|10 g NUTRALYS®S85 Plus pea protein|To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g NUTRALYS®S85 Plus pea protein.
16402603|NCT04871971|Dietary Supplement|20 g NUTRALYS®S85 Plus pea protein|To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g NUTRALYS®S85 Plus pea protein.
16402604|NCT04871971|Dietary Supplement|10 g Whey protein concentrate|To determine the glycaemic response and insulinaemic response to 50g Glucose + 10 g Whey protein concentrate.
16402605|NCT04871971|Dietary Supplement|20 g Whey protein concentrate|To determine the glycaemic response and insulinaemic response to 50g Glucose + 20 g Whey protein concentrate.
16402606|NCT04871971|Dietary Supplement|50 g Glucose|To determine the glycaemic response and insulinaemic response to 50g Glucose
16402607|NCT04871763|Other|Retainers' Cleansing with Geldis®|Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.
16402608|NCT04871763|Other|Retainers' Cleansing with tablets|Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.
16402609|NCT04871763|Other|Retainers' cleansing with water|Patients will brush their essix retainers with a toothbrush under water every night for 2 months.
16402610|NCT04871282|Drug|AL102|AL102 is an inhibitor of gamma secretase-mediated Notch signaling.
16402611|NCT04871282|Other|Placebo|Placebo to match AL102
16402612|NCT04870424|Drug|Colchicine|Colchicine in a loading dosage of 1mg single dose per os the day before TAVI and 1mg single dose at the day of procedure. Thereafter, colchicine 0.5mg once daily per os up to post-procedural day 12.
16402613|NCT04870424|Drug|Placebo|Placebo once daily per os the day before TAVI and once at the day of procedure. Thereafter, once daily per os up to post-procedural day 12.
16402616|NCT04866082|Other|questionnaire|Members of European Society of Intensive Care and European Society of ANaesthesiology and Intensive care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS
16402617|NCT04862585|Drug|Cimetidine|Given IV and/or PO
16402618|NCT04862585|Drug|Dexamethasone|Given IV and/or PO
16402619|NCT04862585|Drug|Diphenhydramine|Given IV and/or PO
16402620|NCT04862585|Drug|Famotidine|Given IV and/or PO
16402621|NCT04862585|Drug|Paclitaxel|Weekly or every 14 day dosing
16402622|NCT04862585|Other|Quality-of-Life Assessment|Ancillary studies
16402623|NCT04862585|Drug|Ranitidine|Given IV and/or PO
16402624|NCT04861077|Drug|[18F]FMISO-PET with contrast-enhanced MRI|Triple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.
16402625|NCT04859842|Other|Pulse Electromagnetic Field|Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with PEMF in prone position. Each session will be 45 minute long with a 15 minute PEMF therapy and a 30 minute conventional therapy program.
16402626|NCT04859842|Other|Interferential Current|Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with Interferential current in prone position. Four interferential electrode will be placed on low back region. Each session will be 45 minute long with a 15 minute interferential current and a 30 minute conventional therapy program.
16402627|NCT04859842|Other|Sham|Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with conventional therapy and sham electrotherapy. Sham application will be performed on prone position with four electrodes and electrodes will stay for 15 minutes on this region.
16402628|NCT04854707|Drug|Follitropin Alfa|Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.
16402629|NCT04854707|Drug|Follicle Stimulating Hormone/Luteinizing Hormone|Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.
16402630|NCT04854707|Drug|Follitropin Alfa|Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.
16402631|NCT04854707|Drug|Follitropin Alfa|Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.
16402632|NCT04854707|Drug|Follicle Stimulating Hormone/Luteinizing Hormone|Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH).
16402633|NCT04853394|Behavioral|MASLIHAT|peer educator intervention
16402634|NCT04853394|Behavioral|TANSIHAT|health education intervention
16402637|NCT04850651|Drug|Pyrotinib；Fluconazole|"Drug: Pyrotinib Participants received a single oral dose of Pyrotinib tablet on the morning of day1 in treatment period 1.
~Drug: Pyrotinib/Fluconazole In treatment period 2, Participants received a single oral dose of pyrotinib tablet on the morning of day9, and received a loading dose of fluconazole capsule on day6 followed by single dose of fluconazole for oral administration from D7 to D18."
16402880|NCT04576117|Drug|Vinblastine Sulfate|Given IV
16402648|NCT04846920|Drug|Belzutifan|40 mg tablet administered orally at a dose of 160 mg, 200 mg, or 120 mg.
16402649|NCT04845685|Device|Continuous Glucose Monitor (CGM)|A device that measures blood sugar levels every 1-5 minutes
16402650|NCT04840589|Drug|BET Bromodomain Inhibitor ZEN-3694|Given PO
16402651|NCT04840589|Biological|Ipilimumab|Given IV
16402652|NCT04840589|Biological|Nivolumab|Given IV
16402653|NCT04838444|Biological|VLA1553|Study participants previously vaccinated with VLA1553 in study VLA1553-301 will be followed up for safety and immunogenicity.
16402654|NCT04838106|Other|Not applicable as observational study|Not applicable as observational study.
16402655|NCT04837001|Drug|FDY-5301|FDY-5301 will be administered as a single IV bolus injection.
16402656|NCT04837001|Other|Placebo|Placebo will be administered as a single bolus injection.
16402657|NCT04836247|Behavioral|Disclosing Recovery: A Decision Aid and Toolkit|Participants will be guided through a workbook and accompanying worksheet designed to help them: (1) decide whether or not they want to share information about their substance use with others, and (2) build skills for disclosing (e.g., planning what to say). Importantly, the intervention is not designed to encourage participants to disclose or not disclose, but rather to help participants decide whether they want to disclose based on their own goals and values.
16402658|NCT04836247|Behavioral|Mindfulness|Participants will be able to choose from several guided meditations to promote mindfulness
16402659|NCT04832178|Dietary Supplement|SUMOR|"SUMOR is a food supplement distributed in Italy by ArcaPharma. regularly entered in the register of Food Supplements of the Ministry of Health (number 62590). Formulated in prolonged-release tablets, each tablet contains the following substances:
~S-Adenosyl-L-Methionine sulfate p-toluenesulfonate 250 mg
~Betaine hydrochloride 250 mg
~Vitamin C 80 mg
~Vitamin B1 1.1 mg
~Vitamin B2 1.4 mg
~Vitamin B6 1.4 mg
~Vitamin B12 2,5 µg
~Folic Acid 200 µg
~Selenium 37 µg"
16402660|NCT04832178|Other|Placebo|Placebo tablet will be identical in appearance to the experimental product (SUMOR).
16402661|NCT04828005|Drug|Nalmefene hydrochloride|3mg Nasal spray
16402662|NCT04828005|Drug|Naloxone hydrochloride|4mg Nasal Spray
16402663|NCT04827953|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
16402664|NCT04827953|Drug|Nab paclitaxel|Nab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
16402665|NCT04827953|Drug|NLM-001|NLM-001 administration during first 3 cycles.
16402666|NCT04827953|Drug|Zalifrelimab|Zalifrelimab administration each 6 weeks.
16402667|NCT04824729|Procedure|Lower limb revascularization|French population of patients with lower-extremity peripheral artery disease who have undergone lower limb revascularization.
16402668|NCT04824729|Procedure|Lower limb revascularization|French population of patients matching the VOYAGER PAD exclusion criteria resembling a subgroup of the PAD revascularized population.
16402669|NCT04820127|Behavioral|personalized care preceded by a standardized assessment|"personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP;
~PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring);
~specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available;"
16402675|NCT04811040|Drug|Oral Lenacapavir|Tablets administered without regard to food
16402676|NCT04811040|Drug|Subcutaneous Lenacapavir|Administered in the abdomen via subcutaneous injections
16402677|NCT04811040|Drug|GS-5423|Administered intravenously
16402678|NCT04811040|Drug|GS-2872|Administered intravenously
16402679|NCT04809285|Device|Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app|Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
16402681|NCT04807972|Drug|ABBV-927|Intravenous (IV) Infusion
16402682|NCT04807972|Drug|Budiglimab|Intravenous (IV) Infusion
16402683|NCT04807972|Drug|modified FOLFIRINOX|Intravenous (IV) Infusion
16402684|NCT04802837|Drug|Ridinilazole|Ridinilazole 200mg dosed BID for 10 days.
16402685|NCT04802837|Drug|Vancomycin|Vancomycin 125mg dosed QID for 10 days.
16402700|NCT04798989|Drug|CY6463|CY6463 Oral Tablet
16402701|NCT04798989|Drug|Placebo|Placebo Oral Tablet
16402702|NCT04796922|Drug|parsaclisib|parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.
16402703|NCT04796922|Drug|rituximab|rituximab will be administered intravenously on select days as per protocol.
16402704|NCT04796922|Drug|obinutuzumab|obinutuzumab will be administered intravenously on select days as per protocol.
16402705|NCT04792788|Procedure|Weaning from mechanical ventilation|Cross over study: 3 periods of 40 minutes in ventilation mode (NAVA or PSV); to register ventilator traces and cardiopulmonary parameters during the last 10 minutes of each period.
16402706|NCT04788550|Combination Product|Fluoridated toothpaste|Group 1 will act as control group. Participants will be advised to brush twice daily using fluoridated toothpaste during the follow up periods. No other fluorides supplements will be allowed to use.
16402707|NCT04788550|Combination Product|fluoride varnish (5% sodium fluoride)|Approximately 0.5-1.0ml fluoride varnish will be applied on the tooth surface (labially) with the paint-on method fom canines to canines. No other fluorides supplements will be allowed to use.
16402708|NCT04788550|Combination Product|CPP-ACP plus crème group|Pea size CPP-ACP plus crème on the tooth surfaces using a clean fingers twice daily after brushing their teeth with fluoridated toothpaste. No other fluorides supplements will be allowed to use.
16402709|NCT04784429|Device|Kenevo or C-Leg 4|Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.
16402710|NCT04784429|Device|Non microprocessor controlled knee (NMPK)|NMPK consistent with current standards of care
16402711|NCT04783948|Other|Brace Treatment|Compliance to brace compression used for the correction of pectus carinatum will be evaluated.
16402712|NCT04782362|Other|Brace Treatment|Body image and quality of life of individuals who have used brace will be evaluated
16402713|NCT04778410|Biological|Magrolimab|Administered intravenously
16402714|NCT04778410|Drug|Azacitidine|Administered either subcutaneously or IV, 75 mg/milligram per square (m^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle
16402715|NCT04778410|Drug|Venetoclax|Administered orally at a dose of 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle
16402716|NCT04778410|Drug|Mitoxantrone|Administered intravenously, 8 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3
16402717|NCT04778410|Drug|Etoposide|Administered intravenously, 100 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3
16402718|NCT04778410|Drug|Cytarabine|Administered intravenously, 1000 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3
16402719|NCT04778410|Drug|CC-486|Administered orally, 300 mg on Days 1-14 during each cycle
16402720|NCT04774237|Drug|BRIMOCHOL™|A single drop in each eye at a visit.
16402721|NCT04774237|Drug|BRIMOCHOL™ F|A single drop in each eye at a visit.
16402722|NCT04774237|Drug|Carbachol|A single drop in each eye at a visit.
16402723|NCT04768881|Drug|Selinexor|Dose and formulation: 80 mg (4 tablets of 20 mg)
16402724|NCT04768881|Drug|Pembrolizumab|Dose and formulation: 400 mg (25 milligrams per milliliter [mg/mL]) Solution
16402725|NCT04767971|Device|Standard Colonoscopy|Colonoscopy with a standard colonoscope
16402726|NCT04767971|Device|G-EYE Colonoscopy|Colonoscopy with a G-EYE Colonoscope
16402727|NCT04766723|Drug|NT 201|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16402728|NCT04766723|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16402729|NCT04760769|Drug|Tavapadon|Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.
16402730|NCT04759768|Drug|Nalmefene Hydrochloride|3mg nasal spray
16402731|NCT04759768|Drug|Nalmefene|1mg intramuscular injection
16402744|NCT04757493|Drug|Prucalopride 2mg|Both prucalopride 2mg and placebo will be administered for 6 weeks. Primary outcome will measure at 2nd and 6th week of treatment.
16402745|NCT04755101|Procedure|EPS, electro-anatomical mapping, ARGP ablation, and pharmacological evaluation.|EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. Sequential ablations will be delivered along theTL until the procedure endpoint is reached. Pharmacological evaluation.
16402746|NCT04755101|Procedure|EPS, electro-anatomical mapping, and pharmacological evaluation.|EPS and electro-anatomical mapping of the right atrium and the surrounding veins. A target line (TL) is traced at the posteroseptal side of the junction, between the right atrium and superior vena cava, facing the mid and caudal parts of the right superior pulmonary vein antrum on the right heart cavities on a CT image imported into the CARTO system. This map will be carefully merged with the CT image and the TL will be visible. No ablation is performed (sham). Pharmacological evaluation.
16402747|NCT04751591|Procedure|Endoscopic resection|Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
16402748|NCT04751591|Procedure|Laparoscopic partial gastrectomy|Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
16402750|NCT04750291|Drug|Botulinum toxin type A|1 infiltration in the biceps muscle with botulinum toxin (100 IU)
16402751|NCT04750291|Other|Placebo|1 infiltration in the biceps muscle with placebo or sterile saline
16402754|NCT04742361|Drug|[18F]PSMA-1007|diagnostic radiopharmaceutical for PET scan
16402759|NCT04731467|Drug|CM-24 and Nivolumab - Dose Escalation|Dose escalation of CM24 with nivolumab in adult subjects with selected recurrent or metastatic solid tumors
16402760|NCT04731467|Drug|CM-24 and Nivolumab - Expansion|Expansion cohort of CM24 in combination with nivolumab in adult subjects with recurrent or metastatic immune checkpoint refractory non-small cell lung cancer
16402761|NCT04731467|Drug|CM-24, Nivolumab, and Nab paclitaxel - Expansion|Expansion cohort of CM24 in combination with nivolumab and nab-paclitaxel in adult patients with metastatic pancreatic cancer
16402762|NCT04730076|Procedure|Standard Balloon Dilation|The standard approach involves a gradual balloon dilation where the balloon is inflated then held at each balloon size for 30-60 seconds then inflated to the next largest balloon diameter size and repeated to the maximum diameter size of that catheter. The dilation session will be repeated as frequently and as many times as needed to achieve the balloon diameter size of 18mm at the discretion of the endoscopist.
16402763|NCT04730076|Procedure|Progressive Balloon Dilation|In the progressive approach, the balloon is continuously inflated over the course of 3-5 minutes starting at the smallest to the largest balloon diameter depending of the balloon catheter used. The dilation will be repeated every 2-3 weeks (total of 2-3 sessions). At the next endoscopic procedure, the balloon diameter used will be the next size up based on previous session.
16402764|NCT04725331|Biological|BT-001|Oncolytic Vaccinia virus containing genes encoding the 4-E03 human recombinant anti-hCTLA4 antibody and human GM-CSF administered at different dose [Phase I, Part A] and at Recommended Dose for Part B [Phase I, Part B and Phase IIa] by intra-tumoral (IT) route.
16402765|NCT04725331|Biological|Pembrolizumab [Keytruda]|Programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.
16402766|NCT04723134|Combination Product|Folinic acid calcium salt|Folinic acid (2.5%) by combination with Placebo
16402767|NCT04721392|Other|Mental fatigue (Stroop task)|"A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words (rood, blauw, groen and geel) will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself."
16402768|NCT04721392|Other|Control (documentary)|In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team.
16402769|NCT04720612|Biological|Omalizumab|Single subcutaneous dose of 375mg of omalizumab and standard of care.
16402770|NCT04720612|Other|Placebo|Single subcutaneous dose of normal saline in a syringe identical to that of the omalizumab arm and standard of care.
16402771|NCT04718896|Drug|bimekizumab|Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.
16402772|NCT04715646|Drug|Brivaracetam|"Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses.
~Tablets Concentration: 10 mg, 25 mg, 50 mg Route of administration: oral
~Oral solution Concentration: 10 mg/ml Route of administration: oral"
16402773|NCT04713319|Drug|Panavital|In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.
16402774|NCT04713319|Other|Placebo|In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.
16402775|NCT04711148|Other|placebo|placebo
16402776|NCT04711148|Drug|orelabrutinib|Orelabrutinib is a white, round, uncoated tablet
16402777|NCT04708951|Device|ENDOCUFF VISION® device|ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning
16402778|NCT04708951|Device|G-EYE® colonoscope|The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning
16402779|NCT04707872|Diagnostic Test|MMDx diagnostic test|Microarray test of gene expression in heart biopsies
16402780|NCT04707872|Diagnostic Test|Prospera|Donor derived cell-free DNA in patient blood
16402781|NCT04707872|Diagnostic Test|HLA antibody|Centralized measurement of HLA antibodies in patient blood
16402782|NCT04707664|Drug|Sargramostim|All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days.
16402783|NCT04707664|Drug|Placebo|All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days.
16402784|NCT04705662|Diagnostic Test|Lactulose breath test|Participants will complete a 3 hour breath test pre and post iron supplementation. This will include taking 4 exploratory samples for volatile organic compound (VOC) analysis.
16402785|NCT04705662|Other|Stool sample|Participants will provide a stool sample pre and post iron supplementation
16402786|NCT04705662|Other|Daily Diary|Monitoring stool form, consistency and frequency on a daily basis
16402787|NCT04705662|Other|Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire|Participants will complete the questionnaire pre and post iron supplementation
16402788|NCT04705662|Dietary Supplement|Ferrous Sulphate|Participants will take Ferrous sulphate 200mg (65mg elemental iron) for 4 weeks (+/- 2 days). Participants will be required to take 2 tablets per day.
16402789|NCT04702750|Behavioral|Targeted memory reactivation (odors)|I will unobtrusively and repeatedly present learning-related odors during sleep using an olfactometer. This method was shown to improve memory in various tasks. The odors will be presented in blocks with short breaks in-between. Odors will be pleasant as to not wake the participant up. The odors will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The odors presented will be non-congruently associated with instructions in a previous learning task. This manipulation is within-subject - all participants will be exposed to all the odors during sleep, but odors will be associated with different instructions for each participant (counterbalanced).
16402790|NCT04702750|Behavioral|Targeted memory reactivation (sounds)|I will unobtrusively and repeatedly present learning-related sounds during sleep using speakers. This method was shown to improve memory in various tasks. The sounds will be presented several seconds apart and the volume will be so adjusted as not to disturb the participant's sleep. The sounds will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The sounds presented will be congruently related to the images in the previous learning task. This manipulation is within-subject - all participants will be exposed to sounds, but different specific sounds will be presented for each individual participant.
16402791|NCT04702724|Behavioral|Targeted memory reactivation (sounds)|I will unobtrusively and repeatedly present learning-related sounds during sleep using speakers. This method was shown to improve memory in various tasks. The sounds will be presented several seconds apart and the volume will be so adjusted as not to disturb the participant's sleep. The sounds will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The sounds presented will be congruently related to the images in the previous learning task. This manipulation is within-subject - all participants will get it, but different specific sounds will be presented for each individual participant.
16402792|NCT04701411|Biological|Darvadstrocel|Darvadstrocel perilesional injection.
16402834|NCT04632264|Other|Saline Placebo|Saline placebo will be initiated post placenta delivery (within 15 seconds).
16402881|NCT04574401|Drug|IS-002|Intravenous injection of IS-002 Investigational Drug
16402798|NCT04700098|Behavioral|Internet-based behavioral treatment for insomnia + HBPR|Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation
16402799|NCT04700098|Behavioral|HBPR only|Home-based pulmonary rehabilitation only
16402801|NCT04691986|Dietary Supplement|Nicotinamide Riboside|Nicotinamide Riboside is a form of vitamin B3 and is naturally occurring in humans.
16402802|NCT04691986|Other|Placebo|Placebo pills contain micro cellulose powder.
16402803|NCT04685226|Drug|ICP-723|ICP-723 is a white, round, uncoated table
16402804|NCT04673032|Device|Radiofrequency Ablation|Radiofrequency Ablation for treatment of chronic pain
16402805|NCT04672889|Dietary Supplement|Placebo|consume 1 sachet per day for 1 months
16402806|NCT04672889|Dietary Supplement|Babyguard® Breast Milk Probiotics|consume 1 sachet per day for 1 months
16402807|NCT04672044|Device|Active rTMS and exercise|active
16402808|NCT04672044|Combination Product|Sham rTMS+Exercise|sham
16402809|NCT04671082|Drug|Tolperisone Hydrochloride|TID
16402810|NCT04671082|Drug|Placebo|TID
16402811|NCT04660201|Biological|AV7909|AV7909 (Liquid Formulation) is an investigational vaccine that is a preformulated, sterile, milky-white suspension for IM injection. It consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and CPG 7909 adjuvant
16402812|NCT04660201|Biological|AV7909|AV7909 (Lyophilized Formulation) is a thermostable, lyophilized version of the liquid AV7909 formulation. Sterile, milky-white suspension for intramuscular injection. It consists of polysorbate 80, CPG7909 adjuvant and AVA bulk drug substance
16402813|NCT04650854|Drug|Rozanolixizumab|Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
16402814|NCT04647487|Drug|LY3484356|Administered orally.
16402822|NCT04634877|Biological|Pembrolizumab|IV infusion
16402823|NCT04634877|Drug|Carboplatin|IV infusion
16402824|NCT04634877|Drug|Paclitaxel|IV infusion
16402825|NCT04634877|Drug|Placebo for pembrolizumab|IV infusion
16402826|NCT04634877|Drug|Docetaxel|IV infusion docetaxel 75 mg/m^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.
16402827|NCT04634877|Drug|Cisplatin|Cisplatin 75 mg/m^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.
16402828|NCT04634877|Radiation|External Beam Radiotherapy (EBRT)|≥4500 cGY given according to local practice, at the discretion of the investigator
16402829|NCT04634877|Drug|Cisplatin (as radiosensitizer)|If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29
16402830|NCT04634877|Radiation|Brachytherapy|Given according to local practice, at the discretion of the investigator
16402831|NCT04633226|Biological|V114|V114 0.5 mL sterile suspension for intramuscular injection.
16402832|NCT04632264|Other|Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery|The intervention is to determine if initiating oxytocin as soon as the fetus is delivered decreased postpartum blood loss. 30 units in 500 milliliters of 0.9% sodium chloride
16402833|NCT04632264|Other|Initiation of standard postpartum oxytocin immediately following placenta delivery|Standard of care includes oxytocin administration post-delivery regardless of delivery mode. This is the comparative group. 30 units in 500 milliliters of 0.9% sodium chloride
16402835|NCT04632264|Other|Saline Placebo|Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).
16402836|NCT04625647|Drug|Sotorasib|Given PO
16402839|NCT04623996|Drug|TP-0184|Oral dose
16402843|NCT04618770|Device|Triathlon PSR Tibial Insert|The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
16402844|NCT04618471|Device|Boston Scientific WaveWriter SCS System|WaveWriter SCS Programming
16402845|NCT04617574|Device|AEON Endostapler|Surgery with AEON Endostapler
16402846|NCT04617574|Device|Endo GIA Reloads with Tri-Staple Technology|Surgery with Endo GIA Reloads with Tri-Staple Technology
16402847|NCT04615845|Biological|Cellgram-DC-PC|Patients will receive 3 times every 2 weeks injection of Cellgram-DC-PC(Autologous dendritic cell) subcutaneously near the inguinal lymph nodes
16402848|NCT04612751|Drug|Datopotamab deruxtecan|Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle (starting Datopotamab deruxtecan dose of 4.0 mg/kg)
16402849|NCT04612751|Drug|Durvalumab|Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle (fixed dose 1120 mg Q3W)
16402850|NCT04612751|Drug|Carboplatin|Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (AUC 5)
16402851|NCT04612751|Drug|Cisplatin|Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (75 mg/m^2)
16402852|NCT04611217|Other|Dietary fiber: 10-25g|10-25 g/day of fiber
16402853|NCT04611217|Other|Dietary fiber: 5g|5 g/day of fiber
16402854|NCT04609878|Drug|BGF MDI 320/28.8/9.6 μg|Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
16402855|NCT04609878|Drug|BGF MDI 320/14.4/9.6 μg|Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
16402856|NCT04609878|Drug|BFF MDI 320/9.6 μg|Budesonide and formoterol fumarate metered dose inhaler
16402857|NCT04609878|Drug|BFF pMDI 320/9 μg|Budesonide/formoterol fumarate pressurized metered dose inhaler
16402861|NCT04605081|Drug|Naltrexone and Bupropion (NB) medication|NB medication will be taken daily in pill form.
16402862|NCT04605081|Other|Placebo|Placebo will be inactive and taken daily in pill form.
16402863|NCT04600791|Device|BATwire Implant Kit|The BATwire Implant Kit is a delivery system for the placement of the BAROSTIM NEO Carotid Sinus Lead.
16402867|NCT04599504|Drug|Lisdexamfetamine Dimesylate (Medication)|Medication will be taken daily in pill form.
16402868|NCT04599504|Other|Placebo|Placebo will be inactive and taken daily in pill form.
16402869|NCT04595786|Drug|Tranexamic acid|20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
16402870|NCT04595786|Drug|0.9% saline|0.9% saline was prepared in a 50ml syringe for intravenous pump
16402872|NCT04593745|Device|Intraocular pressure measurment|Intraocular pressure measurmentt using iCare devise: TONOPEN
16402873|NCT04583891|Behavioral|IntelliCare|IntelliCare is a self-guided, fully automated suite of 6 apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety.
16402874|NCT04583891|Behavioral|Psychoeducation|The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
16402875|NCT04583891|Behavioral|Coaching|The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps.
16402876|NCT04583007|Drug|Lanadelumab|Participants will receive subcutaneous (SC) injection of lanadelumab at a dose of 150 milligrams (mg) at the same frequency (for every 2 weeks [q2wks] or for every 4 weeks [q4wks]) given at the completion of SPRING study until benefit-risk no longer favors the individual participant or an appropriate alternative therapy becomes available or lanadelumab 150 mg/ 1 milliliter (mL) becomes commercially available or the participants turns 12 years of age or participant chooses to discontinue treatment. For participants aged 6-12 years, a dose frequency may be modified based on a benefit-risk assessment and medical decision from the treating physician.
16402877|NCT04576117|Other|Quality-of-Life Assessment|Ancillary studies
16402878|NCT04576117|Other|Questionnaire Administration|Ancillary studies
16402883|NCT04572893|Drug|danicamtiv|Myosin activator
16402884|NCT04572451|Drug|nivolumab|"Nivolumab (BMS-936558-01), 480 mg intravenous (every 4 weeks)
~Treatment must be within 7 days of the last dose of radiation."
16402885|NCT04572451|Drug|BMS-986253|"BMS-986253 (Anti-IL-8), 2,400 mg intravenous (every 2 weeks)
~Treatment must be within 7 days of the last dose of radiation."
16402886|NCT04572451|Radiation|Stereotactic Body Radiotherapy (SBRT)|"Stereotactic Body Radiotherapy (SBRT) (varying doses)
~SBRT: Initial Dose fractionation of 3 or 5 fractions of radiation as determined by the location of the metastases to be irradiated, to at least 1 but no more than 4 metastatic lesions. There will be a minimum of 40 hours between treatments for an individual metastasis.
~SBRT must be completed within a 14-day window, separate from the screening phase. Treatment with nivolumab and BMS-986253 must be within 7 days of the last dose of radiation."
16402887|NCT04572152|Biological|AK119|Subjects will receive AK119 by intravenous administration.
16402888|NCT04572152|Biological|AK104|After AK119 IV, on the same day subjects will receive AK104 by intravenous administration.
16402890|NCT04569461|Drug|pembrolizumab|200 mg of Pembrolizumab (KEYTRUDA) will be given by IV every 3 weeks for 5 cycles, a total of 15 weeks of treatment.
16402891|NCT04569461|Radiation|Stereotactic body radiation therapy|SBRT will begin on week 7 of the study. The radiation will be given every other day in 5 fractions of 6 Gy for a total of 30 Gy of radiation exposure.
16402892|NCT04569461|Drug|Short-term androgen deprivation therapy|Short-term ADT will last for five months. It will consist of treatment with a 1 month dose beginning on Day 0 of the study. Then it will continue with either a single 4 month dose on week 5, or 4 additional 1 month doses, depending on patient and physician preference.
16402893|NCT04569461|Procedure|Radical Prostatectomy|Radical prostatectomy surgery will be performed between week 17 and week 20 of the study, as scheduling permits.
16402894|NCT04568902|Drug|H3B-6545|H3B-6545 oral tablets.
16402895|NCT04568902|Drug|Antihistamine|Antihistamine oral drug.
16402896|NCT04568564|Other|Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation|The exercise program includes breathing exercises (chest-abdominal-lateral basal breathing; 10 repetitions), use of intensive spirometry (20 repetitions) and assisted coughing. Apart from this, a progressive mobilization program will be applied considering patient tolerance and hemodynamic parameters, starting after the patient is taken to the service room. The teleconference exercise call will be continued from the postop 1st day until discharge, twice a day.
16402897|NCT04568564|Other|Exercise booklet|Patients will be interviewed by videoconferencing method at least 1 day before the operation, their first evaluation will be taken and an exercise booklet will be given.
16402898|NCT04568382|Other|CI-PVP (context-informed pre-visit planning)|may experience a single additional phone call from clinic staff in addition to the standard clinic staff chart review, email and/or phone call prior to diabetes office visit
16402899|NCT04568382|Other|Standard PVP (pre-visit planning)|standard clinic staff chart review, email and/or phone call prior to diabetes office visit
16402902|NCT04565483|Drug|Benralizumab Prefilled Syringe|Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion after a one-month screening period. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.
16402903|NCT04551053|Drug|parsaclisib|parsaclisib will be administered QD orally
16402904|NCT04551053|Drug|ruxolitinib|ruxolitinib will be administered BID orally
16402905|NCT04551053|Drug|placebo|placebo will be administered QD orally
16402906|NCT04549571|Other|Decision Aid iCanDecide - ESE website|Utilize the iCanDecide - ESE website
16402907|NCT04549571|Other|Decision Aid iCanDecide - S website|Utilize the iCanDecide - S website
16402908|NCT04549571|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16402909|NCT04549571|Other|Interview|Participate in interview
16402910|NCT04549571|Other|Training|Receive training
16402911|NCT04549571|Other|Media Intervention|Utilize the CDB
16402912|NCT04549571|Other|Best Practice|Utilize usual care
16402913|NCT04549571|Other|Survey Administration|Ancillary studies
16402914|NCT04549571|Other|Quality-of-Life Assessment|Ancillary studies
16402915|NCT04549155|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve a variety of cognitive conditions, and to probe the dynamics of normal brain function.
16402916|NCT04548648|Drug|Acalabrutinib|Acalabrutinib at 100 mg is taken orally approximately every 12 hours until disease progression or unacceptable toxicity.
16402917|NCT04548648|Drug|Isavuconazole|Prophylactic treatment with isavuconazole includes loading dose of 372 mg (2 capsules) administered orally every 8 hours for 6 doses (48 hours), followed by maintenance administration of 372 mg (2 capsules) once daily as long as the subject is on study treatment.
16402918|NCT04544007|Drug|Poly ICLC|Enrolled participants will receive poly-ICLC 20 mcg/kg/dose twice weekly IM (using Monday/Thursday or Tuesday/Friday schedule if possible).
16402919|NCT04536194|Drug|norepinephrine|to treat hypotension under general anesthesia with norepinephrine
16402920|NCT04536194|Drug|dopamine|to treat hypotension under general anesthesia with dopamine
16404358|NCT04997993|Drug|Leflunomide|Leflunomide, 20-50mg PO daily
16402921|NCT04535505|Diagnostic Test|Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology|This is an observational study and there are no interventions. The purpose of the study is to compare the accuracy （including sensitivity and specificity）of the new CPA platform based on CRISPR technology detection method and the gold standard in detecting pertussis patients.
16402924|NCT04530162|Procedure|Ultrasound guided nerve block|nerve block using bupivacaine and dexamethasone.
16402925|NCT04528446|Radiation|Dual-energy X-ray absorptiometry|DXA whole body, hip, spine, and radius at baseline, and 12-month visit.
16402926|NCT04528446|Radiation|High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)|HR-pQCT of the radius and tibia at baseline, and 12-month visit.
16402927|NCT04528446|Other|Blood draw and Urine collection|The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.
16402928|NCT04528446|Other|Questionnaires|Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.
16402929|NCT04526691|Drug|Datopotamab deruxtecan|Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle (starting datopotamab deruxtecan dose of 4.0 mg/kg)
16402930|NCT04526691|Drug|Pembrolizumab|Intravenous infusion Q3W on Day 1 of each 21-day cycle (fixed pembrolizumab dose 200 mg Q3W)
16402931|NCT04526691|Drug|Carboplatin|Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (AUC 5)
16402932|NCT04526691|Drug|Cisplatin|Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (75 mg/m^2)
16402933|NCT04519645|Drug|Lacosamide intravenous|Study participants will receive lacosamide (LCM) as an intravenous (iv) infusion during the Treatment Period.
16402934|NCT04519645|Drug|Lacosamide oral|Study participants may receive lacosamide (LCM) as an oral solution during the Extension Period.
16402935|NCT04519645|Other|Active Comparator|Active Comparator treatment will be chosen and dosed based on StOC (per local practice and treatment guidelines).
16402936|NCT04518410|Biological|bamlanivimab|7000 mg or 700 mg (Phase 2), 700 mg (Phase 3). Administered by single IV infusion. Phases 2 and 3 completed for bamlanivimab. Participants are no longer being randomized to this intervention.
16402937|NCT04518410|Drug|Placebo (IV)|Commercially available 0.9% sodium chloride solution.
16402938|NCT04518410|Biological|BRII-196/BRII-198|1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
16402939|NCT04518410|Biological|AZD7442 (IV)|300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
16402940|NCT04518410|Biological|AZD7442 (IM)|Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
16402941|NCT04518410|Drug|SNG001|1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device).
16402942|NCT04518410|Drug|Camostat|200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
16402943|NCT04518410|Drug|Placebo (IM)|Commercially available 0.9% sodium chloride Injection, USP. Administered intramuscularly as 2 separate injections, sequentially for one dose. Injections administered in the side of the thigh, one injection in each thigh.
16402944|NCT04518410|Drug|Placebo (Inhaled solution)|Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device).
16402945|NCT04518410|Drug|Placebo (oral tablet)|200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days.
16402946|NCT04518410|Biological|BMS-986414 + BMS-986413|Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg).
16402947|NCT04518410|Drug|Placebo (SC injections)|Administered SC as 4 separate injections for one dose.
16402948|NCT04518410|Biological|SAB-185 (3,840 Units/kg)|Administered by IV infusion as single dose.
16402949|NCT04518410|Biological|SAB-185 (10,240 Units/kg)|Administered by IV infusion as single dose.
16402950|NCT04518410|Drug|CASIRIVIMAB + IMDEVIMAB|600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry.
16402951|NCT04515524|Other|Non-Interventional|No study treatment will be administered in this study
16402952|NCT04511208|Device|Cooling Vest|Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
16402953|NCT04511208|Device|Control Group without cooling vest|Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
16402954|NCT04506099|Device|TINS Active protocol|Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
16403046|NCT04376619|Other|KDIGO guidelines|KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.
16403173|NCT04165798|Procedure|Tumor Tissue Collection|Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
16402955|NCT04506099|Device|Sham protocol|Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
16402956|NCT04504032|Drug|Rivaroxaban|Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
16402957|NCT04504032|Drug|Placebo|Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
16402958|NCT04502888|Drug|Drug: SL-172154|The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
16402959|NCT04501614|Drug|Ponatinib|Ponatinib tablets.
16402960|NCT04501614|Drug|Ponatinib AAF|Ponatinib age appropriate formulation (AAF).
16402961|NCT04501614|Drug|Chemotherapy Agents|Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), daunorubicin. Agents for intrathecal (IT) chemotherapy, central nervous system (CNS)-1/2: IT methotrexate chemotherapy, or CNS-3: triple intrathecal (ITT) methotrexate, hydrocortisone, cytarabine. Chemotherapy agents for consolidation include dexamethasone, vincristine, methotrexate, PEG-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), cyclophosphamide, etoposide, CNS-1/2: IT methotrexate chemotherapy, CNS-3: ITT chemotherapy methotrexate, hydrocortisone, cytarabine. The doses for chemotherapy agents for reinduction will be given as per standard of care.
16402962|NCT04496895|Dietary Supplement|Placebo|consume 1 sachet per day for 2 months
16402963|NCT04496895|Dietary Supplement|orange peel fermentation|consume 1 sachet per day for 2 months
16402964|NCT04492722|Drug|AZD5718|Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.
16402965|NCT04492722|Drug|Dapagliflozin 10 mg|Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.
16402966|NCT04492722|Drug|Placebo|Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.
16402967|NCT04492605|Dietary Supplement|Placebo|consume 1 capsule per day for 2 months
16402968|NCT04492605|Dietary Supplement|TCI378 Probiotics|consume 1 capsule per day for 2 months
16402969|NCT04492605|Dietary Supplement|TCI507 Probiotics|consume 1 capsule per day for 2 months
16402970|NCT04492293|Drug|ICP-192|ICP-192 is a white, round, uncoated table
16402971|NCT04490720|Dietary Supplement|Placebo|consume 1 sachet per day for 2 months
16402972|NCT04490720|Dietary Supplement|Buckwheat husk extract|consume 1 sachet per day for 2 months
16402974|NCT04485858|Device|CorNeat KPro|CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva
16402975|NCT04484025|Drug|Ebselen|Glutathione peroxidase mimetic
16402976|NCT04484025|Drug|Placebo|Matching placebo containing excipients
16402977|NCT04483973|Drug|Ebselen|Glutathione peroxidase mimetic
16402978|NCT04483973|Drug|Placebo|Matching placebo containing excipients
16402979|NCT04480294|Drug|HRS5091|"Single dose in group 1-5
~Multiple doses in group 6-9"
16402980|NCT04478708|Biological|AMG 133|Participants will receive AMG 133 as a single dose in Part A and multiple doses in Part B.
16402981|NCT04478708|Drug|Placebo|Participants will receive placebo as a single dose in Part A and multiple doses in Part B.
16402982|NCT04475536|Device|TANSEI stent|stenting with the TANSEI sirolimus-eluting stent
16402983|NCT04472026|Behavioral|Counseling using the electronic conversation aid|This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process.
16402984|NCT04467489|Other|observational|There is no intervention for any group in this observational study.
16402985|NCT04462172|Device|FNS|perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
16402986|NCT04462172|Device|MCS|three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
16402987|NCT04459715|Drug|Debio 1143|Debio 1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.
16402988|NCT04459715|Drug|Cisplatin|Cisplatin administered as an IV infusion every 3 weeks (Q3W).
16402989|NCT04459715|Radiation|Intensity Modulation Radiation Therapy (IMRT)|70 Gy given in 35 fractions over 7 weeks.
16402990|NCT04459715|Drug|Placebo|Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
16402991|NCT04459091|Dietary Supplement|Amino Essential Acid|8 gr die in two administration
16402992|NCT04459091|Dietary Supplement|placebo|8 gr die in two administration
16402993|NCT04458259|Drug|PF-07265807|Given QD 2 weeks on/1 week off
16402994|NCT04458259|Drug|Sasanlimab|Given SC 225 mg Q3W
16402995|NCT04458259|Drug|Axitinib|Dosed per package label starting with 5 mg PO BID
16402996|NCT04457778|Drug|M6223|Participants will receive an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC (Safety Monitoring Committee) until the maximum tolerated dose (MTD) has been reached or confirmed disease progression.
16402997|NCT04457778|Drug|Bintrafusp alfa|Participants will receive an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) or Q3W on Day 1 of each Cycle (Cycle is of 21 days) until confirmed disease progression.
16403172|NCT04165798|Diagnostic Test|Tumor Imaging|Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
16402998|NCT04457778|Drug|M6223|Participants will receive an IV infusion of M6223 at escalated doses Q3W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression. Additionally, an every Q3W regimen of M6223 in combination with bintrafusp alfa will be tested after the MTD of M6223 Q2W in combination with bintrafusp alfa has been defined, or after the highest dose level anticipated in the Q2W combination regimen has been tested in at least 3 participants, whichever comes first.
16402999|NCT04452500|Drug|CORT108297|CORT108297- 180mg daily for 7 days
16403000|NCT04452500|Drug|Placebo|Placebo- 180mg daily for 7 days
16403003|NCT04449042|Procedure|airway management during sedation or general anesthesia|airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure
16403004|NCT04441905|Other|Placebo|One time 60-minute IV infusion of lyophilized placebo for SAR440894
16403005|NCT04441905|Biological|SAR440894|One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
16403006|NCT04440644|Behavioral|BBI|administration of psychometric test
16403007|NCT04434196|Drug|CC-99282|CC-99282
16403008|NCT04434196|Drug|Obinutuzumab|Obinutuzumab
16403009|NCT04430283|Drug|FDY-5301|FDY-5301 is Sodium Iodide administered as an isotonic solution for intravenous injection with a concentration of 7.2 mg/ml.
16403010|NCT04430283|Other|Placebo|Placebo is delivered as a single dose, non-reserved liquid parenteral consisting of a formulation matched compendial saline.
16403011|NCT04429542|Drug|BCA101|EGFR/TGFβ fusion monoclonal antibody
16403012|NCT04429542|Drug|Pembrolizumab|anti-PD-1
16403013|NCT04427982|Behavioral|dance|Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.
16403014|NCT04427982|Behavioral|diabetes education|The dance classes will be followed by a brief diabetes education and discussion session.
16403015|NCT04421040|Device|Biotronic 3 implant of device|The Biotronic 3 device will be implanted by the research team physician.
16403016|NCT04421040|Device|Biotonic 3 explant of device|The Biotronic 3 device will be removed from the patient by the research team physician.
16403017|NCT04417621|Drug|LXH254|LXH254 will be supplied as tablet for oral use.
16403018|NCT04417621|Drug|LTT462|LTT462 will be supplied as hard gelatin capsule for oral use.
16403019|NCT04417621|Drug|Trametinib|Trametinib will be supplied as film-coated tablet for oral use
16403020|NCT04417621|Drug|Ribociclib|Ribociclib will be supplied in tablets and hard gelatin capsules.
16403023|NCT04409652|Procedure|Head on bed|During emergence, head is kept on bed without pillow.
16403024|NCT04409652|Procedure|Head on pillow|During emergence, head is kept on pillow.
16403026|NCT04400123|Drug|Famitinib malate|"TR group:
~The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h.
~RT group:
~The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h."
16403027|NCT04397978|Radiation|Stereotactic radiotherapy|Local ablative therapy with SRT
16403032|NCT04381468|Drug|Pepinemab|Pepinemab is a humanized IgG4 monoclonal antibody. The antibody is formulated at 20 mg/mL in 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80
16403033|NCT04381468|Drug|Placebo|Placebo consists of formulation buffer only which is 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80
16403034|NCT04380038|Drug|Dupilumab Injectable Product|Nasal inoculation, single dose 300 TCID50 in 1ml.
16403035|NCT04379596|Drug|Fluorouracil (5-FU)|5-FU: administered as an IV infusion
16403036|NCT04379596|Drug|Capecitabine|Capecitabine: administered orally
16403037|NCT04379596|Biological|Durvalumab|Durvalumab: administered as an IV infusion
16403038|NCT04379596|Drug|Oxaliplatin|Oxaliplatin: administered as an IV infusion
16403039|NCT04379596|Biological|Trastuzumab|Trastuzumab: administered as an IV infusion
16403040|NCT04379596|Drug|Trastuzumab deruxtecan|T-DXd: administered as an IV infusion
16403041|NCT04379596|Drug|Cisplatin|Cisplatin: administered as an IV infusion
16403042|NCT04379596|Biological|Pembrolizumab|Pembrolizumab: administered as an IV infusion
16403043|NCT04379284|Other|Biospecimen collection|"Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.
~Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab."
16403045|NCT04376619|Other|remote ischemic preconditioning|inflation and deflation of cuff 5min each cycle repeated 3 times
16403244|NCT04009499|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16403047|NCT04376385|Behavioral|GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)|"It is a self-applied treatment through the web psicologíaytecnología.labpsitec.es. There are 8 treatment modules. Each module lasts approximately 60 minutes. It contains written information, videos, audios, photos and interactive questionnaires. The total duration of treatment is 8-10 weeks. A support call will be made a week (maximum 10 minutes) to answer questions and reinforce and motivate the patient. No additional clinical content or counselling will be provided.
~Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention"
16403048|NCT04373837|Behavioral|Prismatic googles inducing prismatic adaptation (PA) associated to Virtual Reality (VR)|"The experimental condition consists of PA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
~Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with prismatic googles inducing a rightward shift of the visual field (experimental condition). After lenses removal, a leftward shift of spatial attention will be produced.
~Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action."
16403049|NCT04373837|Other|Neutral googles inducing no-adaptation (NA) associated to Virtual Reality (VR)|"The sham condition of this study consists of NA procedure associated to VR task: the pointing task will be followed by 5 sessions of VR task.
~Pointing task. Patients will perform a session of 90 pointing movements toward a visual target presented in a variety of positions on the right, the left or at the center of the visual field. This pointing task will be performed with neutral goggles (control condition), which should not induce a shift of the visual field and of spatial attention.
~Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Patients will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action."
16403050|NCT04373616|Biological|ACI-24|injections
16403051|NCT04373616|Biological|Placebo|injections
16403057|NCT04370054|Biological|PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy|Single IV infusion
16403058|NCT04350138|Biological|Meningococcal Group B Vaccine|A combination vaccine consisting of rMenB and OMV NZ.
16403059|NCT04350138|Other|Placebo|150mM sodium chloride (0.9% saline solution).
16403060|NCT04344795|Drug|TPST-1495 twice daily|TPST-1495 administered orally twice daily
16403061|NCT04344795|Drug|TPST-1495 once daily or on intermittent schedule|TPST-1495 administered orally once daily or on intermittent schedule
16403062|NCT04344795|Drug|Pembrolizumab|Pembrolizumab dosed per label recommendations
16403063|NCT04341090|Drug|Apatinib Mesylate|Single dose of apatinib mesylate after high-fat meal, low fat meal and fast
16403070|NCT04338529|Drug|Binosto 70Mg Effervescent Tablet|As discussed in group descriptions
16403071|NCT04324814|Drug|SHR-1701|Anti-PD-L1/TGFβ fusion protein
16403072|NCT04317586|Device|Trident II Tritanium Acetabular Shell for Revision|A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
16403076|NCT04313608|Drug|Glofitamab|Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.
16403077|NCT04313608|Drug|Gemcitabine|Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
16403078|NCT04313608|Drug|Oxaliplatin|Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
16403079|NCT04313608|Drug|Mosunetuzumab|Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.
16403080|NCT04313608|Drug|Obinutuzumab|Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.
16403081|NCT04313608|Drug|Tocilizumab|Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).
16403082|NCT04294680|Device|Cryotherapy|see opiate sparing description
16403083|NCT04273854|Device|OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app®|The intervention will consist of physician-optimised self-management of post-partum BP. Women will follow a 'smartphone' app based algorithm for medication-titration, which will provide individualised dose titration advice. This is overseen and any change is approved by physicians who can review the uploaded readings and respond to tele-monitored abnormal readings in a timely fashion.
16403331|NCT03906526|Drug|Nivolumab|IV Nivolumab
16403084|NCT04272450|Diagnostic Test|respiratory muscle strenght measurement|Maximum inspiratory pressure-maximum expiratory pressure. The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated.
16403087|NCT04266418|Dietary Supplement|Placebo|consume 1 sachet per day for 2 months
16403088|NCT04266418|Dietary Supplement|Banana flower stamens extract|consume 1 sachet per day for 2 months
16403089|NCT04263896|Drug|Polyethylene Glycol 3350|Participants will take 1 17g pack per day for 10 days preceding surgery.
16403092|NCT04254731|Drug|Same individuals treated with racemic methadone and switched to levomethadone (R-methadone)|
16403093|NCT04254627|Drug|Etanercept|Etanercept 50 mg weekly injection
16403094|NCT04254627|Drug|Mifepristone|Mifepristone 300 mg pill
16403095|NCT04253015|Other|Data-collection|Data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs.
16403096|NCT04245150|Other|Stool sample|Stool sample
16403097|NCT04245150|Other|Skin Swab Sample|Skin Swab Sample
16403098|NCT04243330|Behavioral|Audit and Feedback|The following components will be incorporated into the audit and feedback intervention: i) individualized facility performance data (site level), ii) frequent delivery intervals (monthly), iii) comparisons with other sites, iv) graphical and text form displays of information, v) constructive, non-punitive tone, vi) target performance or benchmark provided, and vii) specific actions or recommendations for meeting the target.
16403099|NCT04243330|Behavioral|External Facilitation|Facilitation will be conducted by a team of facilitators who will employ the facilitation process to improve uptake of VA Risk ID. Trained external facilitators will flexibly deliver the facilitation process utilizing an integrated set of implementation strategies (e.g., stakeholder engagement, identification of barriers and facilitators, education, problem solving, the use of formative data, communication, and ongoing support).
16403100|NCT04242498|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16403101|NCT04242498|Other|Placebo|Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
16403111|NCT04238247|Behavioral|Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention|"A bilingual emergency department (ED)-based precision prevention intervention grounded in Self-Determination Theory. The Basic TCBD/ABCB intervention integrates one personalized counseling session based on principles of motivational interviewing (MI) and eHealth components including a tailored mobile-friendly educational website and short message service (SMS) text message communications with the goal of improving child passenger safety.
~Participants receive monthly text message requests to submit photographs depicting the child as they usually travel. Feedback is provided via text message to correct any observed errors or misuse. Tailored informational and motivational text messages are sent twice each month."
16403112|NCT04238247|Behavioral|Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention|The Enhanced TBDC/ABCB Intervention includes a second motivational interviewing session. Basic Intervention text messages continue with an additional 1-2 tailored text messages per month.
16403113|NCT04233801|Drug|Empagliflozin|Empagliflozin
16403114|NCT04233801|Drug|Placebo|Placebo
16403115|NCT04225923|Drug|NPC-21 Low dose|NPC-21 will be administered via an approximately 60-minute intravenous infusion
16403116|NCT04225923|Drug|NPC-21 High dose|NPC-21 will be administered via an approximately 60-minute intravenous infusion
16403117|NCT04225923|Drug|NPC-21 Placebo|Placebo will be administered via an approximately 60-minute intravenous infusion
16403118|NCT04225117|Drug|enfortumab vedotin|intravenous (IV) infusion
16403119|NCT04224688|Drug|Rozanolixizumab|Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points.
16403120|NCT04224688|Other|Placebo|Study participants receive placebo by subcutaneous infusion at pre-specified time points.
16403121|NCT04223570|Drug|Ameluz|Ameluz is a topical gel approved for use in photodynamic therapy for treatment of actinic keratoses.
16403122|NCT04223570|Device|Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera|This is a portable device that uses a camera to non-invasively and efficiently measure the level of protoporphyrin IX in various areas skin. This camera will be used in all participants to measure the level of protoporphyrin IX in various areas of skin as detailed in the study description.
16403486|NCT03451006|Drug|Metformin|Oral metformin (up to 2gm) will be given in divided doses
16403123|NCT04223570|Device|Photodynamic Therapy Light|This blue light is FDA approved to work with the Ameluz gel as part of photodynamic therapy and works with the photosensitizing Ameluz gel to form reactive oxygen species that specifically target precancerous lesions, such as actinic keratoses, without damaging normal, non-cancerous skin.
16403124|NCT04218110|Drug|Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic|Application of antiseptic drug to the inguinal area of the subjects
16403125|NCT04218110|Drug|Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic|Application of antiseptic drug to the inguinal area of the subjects
16403126|NCT04218110|Drug|Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic|Application of antiseptic drug to the inguinal area of the subjects
16403127|NCT04218110|Drug|Prevantics 3.15 % / 70 % Swabstick|Application of antiseptic drug to the inguinal area of the subjects
16403128|NCT04216121|Radiation|Local ablative therapy|Stereotactic body radiotherapy
16403129|NCT04216121|Procedure|Local ablative therapy|Surgery
16403147|NCT04208321|Other|Placebo|Placebo will be supplied as matching tablets (to 40 mg and 80 mg VT-1598 tablets) containing the inactive components of VT-1598.
16403148|NCT04208321|Drug|VT-1598|VT-1598 is a novel oral agent for the treatment of fungal infections. It will be supplied as 40 mg and 80 mg tablets.
16403149|NCT04207918|Radiation|Radiotherapy|44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.
16403150|NCT04207918|Drug|Nimotuzumab|400mg, by intravenous infusion once a week in 4-6 weeks.
16403151|NCT04207918|Drug|S-1|40-60mg/m2/d，orally twice a day concurrently with radiotherapy.
16403152|NCT04201548|Other|Endurance Training|"These patients will perform an aerobic exercise with a moderate intensity cycle ergometer. The exercise session on an exercise bike will last 33 minutes at a constant load, starting from an intensity equal to the load of 60% of the maximum load (max watt) achieved at the incremental test.
~Working volume = 60 X 33 = 1980"
16403153|NCT04201548|Other|Long High Intensity Interval Training|"The patients assigned to the Long-HIIT group will perform a 32-minute interval work with 4x4 protocol (active phase x passive phase) performing 4 minutes at an intensity of 80-85% of the Max Watt (active phase) spaced from 4 minutes to 40% of the Max Watt (passive phase). The goal of high intensity work will be to bring the heart rate to a level close to 85-90% of the maximum cardiac frequency achieved in the incremental exercise test. If this target is not reached within the session, the load of the next one will be increased in the following session with 10 watt steps.
~Working volume = 16 X 85 + 16 x 40 = 2000"
16403154|NCT04201548|Other|Short High Intensity Interval Training|"The patients assigned to the Short-HIIT group will perform an interval work with initial intensity equal to 100% of the Max Watt highlighted in the incremental exercise stress test in the phase (30 seconds) followed by a passive phase of 30 seconds at 50% of the Max Watt for a period of 26 minutes a day. The intensity will be gradually increased during the sessions with symptom-based progression, according to the protocol of Maltais et al. with steps of 10 watts each increment.
~Working volume = 13 X 100 + 13 x 50 = 2050"
16403155|NCT04200456|Drug|Rozanolixizumab|Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points.
16403156|NCT04200456|Other|Placebo|Study participants receive placebo by subcutaneous infusion at pre-specified time points.
16403157|NCT04192487|Drug|Crofelemer delayed-release tablets 125mg|1 crofelemer delayed-release tablet twice daily at least 8 hours apart for 30 days with or without meals.
16403158|NCT04185285|Device|Percutaneous coronary intervention, stents|
16403159|NCT04180462|Other|Practice Facilitation|Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.
16403160|NCT04180462|Other|Education|An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.
16403161|NCT04180462|Other|Audit and Feedback|Audit and feedback of vaccine coverage to increase motivation to engage in practice change.
16403162|NCT04180462|Other|Communication Strategy|A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.
16403163|NCT04173104|Diagnostic Test|PET/MR with [18F]PARPi|One PET/MR study (with up to 3 scan times) with [18F]PARPi
16403164|NCT04173104|Drug|[18F]PARPi|Injection of <100ug of [18F]PARPi prior to 1 PET/MR
16403165|NCT04171856|Device|REAplan(R)|motor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm
16403166|NCT04170543|Drug|MEDI3506|Dose 1, Dose 2, Dose 3, Dose 4
16403167|NCT04170543|Drug|Placebo|Placebo
16403168|NCT04170543|Drug|Dapagliflozin|Dapagliflozin 10 mg
16403169|NCT04169594|Diagnostic Test|3D Gait Analysis with Statistical Parametric Mapping|A 3D motion capture system will be used for gait analysis. Vector field statistics will be used to simplify the clinical interpretation of time varying movement patterns.
16403170|NCT04167514|Biological|Alpha-1 antitrypsin (AAT)|AAT is a lyophilized product for intravenous administration
16403171|NCT04167514|Drug|Placebo|Albumin solution administered intravenously
16403487|NCT03451006|Drug|Placebo|Oral Placebo will be given in divided doses
16403174|NCT04165798|Procedure|Blood Sample Collection|"Participants will have blood samples drawn for analysis of:
~genetics
~ribonucleic acid (RNA)
~serum biomarker
~plasma biomarker
~circulating tumor DNA (ctDNA)"
16403175|NCT04165096|Biological|Pembrolizumab|IV infusion
16403176|NCT04165096|Biological|MK-5890|IV infusion
16403177|NCT04165096|Biological|MK-4830|IV infusion
16403178|NCT04165096|Drug|diphenhydramine|PO
16403179|NCT04165096|Drug|acetaminophen|PO
16403180|NCT04165096|Biological|MK-0482|IV infusion
16403181|NCT04165083|Biological|Pembrolizumab|IV infusion
16403182|NCT04165083|Biological|MK-4830|IV infusion
16403183|NCT04157517|Drug|Modakafusp Alfa|Modakafusp alfa intravenous infusion.
16403184|NCT04157517|Drug|Pembrolizumab|Pembrolizumab intravenous infusion.
16403185|NCT04154163|Diagnostic Test|Dried blood Spot (DBS)|Dried Blood Spot filter paper and sponges
16403186|NCT04154163|Diagnostic Test|Venous blood sampling|Venous blood
16403187|NCT04153929|Drug|BI 456906|Injection
16403188|NCT04153929|Drug|Placebo|Injection
16403189|NCT04153929|Drug|Semaglutide|Injection
16403190|NCT04152967|Device|new-designed PTFE valved conduits|In this prospective comparative research, all patients will be divided into two groups randomly with 100 patients in each group. One group will use the new-designed PTFE valved conduits and another one will implant the bovine jugular vein valved conduits.
16403191|NCT04152967|Device|Bovine jugular vein valved conduits|In this prospective comparative research, all patients will be divided into two groups randomly with 100 patients in each group. One group will use the new-designed PTFE valved conduits and another one will implant the bovine jugular vein valved conduits.
16403192|NCT04144517|Drug|ALKS 4230|Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
16403193|NCT04144517|Drug|Pembrolizumab|IV infusion over 30 minutes administered on Day 1 of each cycle
16403194|NCT04142177|Other|Pain EASE|The internet-based pain self-management program consists of open access to the Pain EASE program (Pain E-health for Activity, Skills, and Education) for the duration of participation in the trial. Pain EASE has 10 pain coping skill modules: pain education, setting personal goals, planning meaningful activities, physical activity (stretching, body mechanics, and a pedometer-based walking program), relaxation, developing healthy thinking patterns, pacing and problem-solving, improving sleep, effective communication, and future planning.
16403195|NCT04142177|Procedure|Tailored exercise|Findings from the initial examination and the Keele STarT Back Screening Tool (Hill, et al., 2011) will be used by the physical therapist to guide and tailor the intervention to individual participants which will involve up to 8 treatment sessions with ongoing home exercise. For most participants, exercise and physical activity will focus on walking in addition to motor control and stabilization exercises for the low back with flexibility exercises when lumbar spine stiffness is present.
16403196|NCT04142177|Other|Continued Care and Active Monitoring|CCAM will not be standardized keeping in line with the pragmatic nature of this trial. CCAM may be variable across sites and for individual participants reflecting de facto clinical practice for cLBP. Clinical practice may involve pharmacological and non-pharmacological treatments for cLBP. Current analgesics (including opioids, acetaminophen, NSAIDs, topical analgesics (capsaicin), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, skeletal muscle relaxants, and alpha-2-delta ligands (gabapentin-like drugs)) and non-pharmacological treatments may be continued by participants. CCAM participants will be encouraged to discuss pain problems with their treating physician, but not begin new treatments if possible. Patients will specifically be discouraged from starting CBT, chiropractic, or yoga. Other than this, there will be no attempt by study personnel to influence pain management.
16403197|NCT04142177|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants randomized to CBT in Step 2 will receive face-to-face treatment with a trained therapist using the VA's CBT-chronic pain (CBT-CP) protocol involving one planning session and 9 treatment sessions (10 total) over 3 months. The VA's CBT-CP protocol consists of 11 core CBT-CP modules that can be completed in up to 10 sessions. Weekly, individual sessions of 45-50 minutes are recommended, although it is recognized that bi-weekly or other arrangements are often made to fit practical needs.
16403198|NCT04142177|Procedure|Spinal Manipulation Therapy (SMT)|After examination by a qualified Doctor of Chiropractic (DC), a SMT intervention consisting of up to 10 sessions over 3 months will be designed focusing on spinal manipulation and/or mobilization of the lower thoracic, lumbar and/or sacroiliac joints. Adjunctive use of myofascial and/or stretching techniques are allowed as they are commonly used along with SMT, and can be considered a standard accompaniment to SMT.
16403199|NCT04142177|Procedure|Yoga|The Yoga for Veterans with cLBP program consists of up to 10 weekly, 60-minute instructor-led sessions along with 15-20 minutes of yoga practiced at home each non-session day. The initial session is 75 minutes (15 minutes longer than the other sessions). The yoga program can be considered classical hatha yoga with influences from Iyengar and Viniyoga yoga. These styles emphasize modifications and adaptations including the use of props such as straps and blocks to minimize the risk of injury and make the poses accessible to people with health problems and limitations (Iyengar, 1979). The instructor leads participants through a series of 23 yoga poses (32 total variations) at a slow-moderate pace.
16403200|NCT04122625|Drug|Debio 1143|Debio 1143 will be administered capsule orally once daily for 10 consecutive days every 2 weeks and Days 15-24 q4w. The dose of Debio 150 mg can be escalated to 200 in Part A and it is to be decided in Part B.
16403201|NCT04122625|Drug|Nivolumab|Nivolumab will be administered as 240 mg IV infusion on Days 1 and 15 of a 28-day cycle.
16403202|NCT04120701|Drug|mFOLFOX6|Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
16403203|NCT04108481|Drug|Durvalumab|Immunotherapy
16403204|NCT04108481|Radiation|Yttrium-90 RadioEmbolization|Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver
16403205|NCT04107623|Diagnostic Test|Indocyanine Green|Using Q-ICG perfusion of the remaining Gastric Conduit will be compared
16403242|NCT04019444|Biological|Rabies Vaccine|The RABAVERT Vaccine is an inactivated, purified chick embryo cell vaccine (PCECV). It consists of lyophilized rabies virus (strain Flury LEP) that has been propagated in chicken fibroblasts, inactivated with beta-propiolactone, and concentrated and purified by centrifugation
16403243|NCT04014205|Drug|Orelabrutinib (ICP-022)|ICP-022 The drug product is a white, round, uncoated tablet
16403206|NCT04097964|Behavioral|brief intervention|1 minute or less of anticipatory guidance will be provided for adolescents reporting no use in the past year, a 3-5 minute abbreviated brief intervention including raising the subject, asking more questions, and correcting misinformation will be provided for adolescents reporting substance use once or twice in the past year, and a 5-10 minute full brief intervention will be provided, including the above steps as well as assessing readiness and negotiating change and scheduling a follow-up to potentially include a referral to treatment will be provided to adolescents reporting monthly to weekly use in the past year.
16403207|NCT04097964|Behavioral|treatment as usual|standard care conducted by primary care providers during clinic visits
16403208|NCT04092504|Other|gero-erat|"The intervention is a standardize Care Plan which will be developed based on the evidence of caring for eldery patients in a trauma setting. The Care Plan will have its base in, the concept of ERAS and CGA. Also, patient experience will be taken in consideration and complement the care pathway.
~Patients admitted to the trauma unit will be given the care and asked to be a part of the study witch include to fill out surveys at baseline, six months and 1 year."
16403211|NCT04089150|Radiation|Stereotactic Radiotherapy (SBRT)|40 Gray (Gy) in 5 fractions, 2-3 fractions per week over two weeks, 8 Gy per fraction
16403212|NCT04089150|Drug|mFOLFIRINOX|"Day 1: oxaliplatin 85mg/m2 + irinotecan 150mg/m2 + leucovorin 50mg
~5-FU 2400mg/m2 continuous IV infusion, 46 hour continuous infusion
~14-day cycle, 6 cycles"
16403213|NCT04089150|Drug|Gemcitabine + Nab-paclitaxel|"Day 1, Day 8 and Day 15 gemcitabine 1000mg/m2 + nab-paclitaxel 125mg/m2
~28-day cycle, 3 cycles"
16403214|NCT04089150|Drug|Gemcitabine + Capecitabine|"Week 1, 2 and 3, qw: 1000 mg/m2 gemcitabine
~21 days continuous: 830 mg/m2 oral capecitabine + 7 days rest
~28-day cycle, 3 cycles"
16403215|NCT04089150|Procedure|Pancreatoduodenectomy (Whipple procedure)|R0 resection. When the tumour is within the head of the pancreas, a standard Whipple's procedure and level 2/3 dissection with modification to obtain margin clearance will be offered. For lesions in the tail, a standard modular resection will be offered.
16403216|NCT04087278|Dietary Supplement|Red Raspberry Ellagitannin Extract|Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
16403217|NCT04087278|Dietary Supplement|Matching Placebo|Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)
16403218|NCT04086966|Drug|[68Ga]PSMA-PET/MRI or PET/CT|[68Ga]PSMA-PET/MRI or PET/CT
16403223|NCT04082780|Drug|Rifamycin SV MMX|Intervention arm
16403224|NCT04082780|Other|Placebo|Placebo arm
16403225|NCT04079712|Drug|Cabozantinib S-malate|Given PO
16403226|NCT04079712|Biological|Ipilimumab|Given IV
16403227|NCT04079712|Biological|Nivolumab|Given IV
16403228|NCT04075487|Other|Web-module for patient education and planning|Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan
16403229|NCT04073420|Device|Surgical Heart Valve Repair Products|Surgical heart valve repair products.
16403230|NCT04073420|Device|Surgical Heart Valve Replacement Products|Surgical heart valve replacement products.
16403234|NCT04044716|Device|Auricular acupressure|Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist.
16403235|NCT04044716|Other|Standard of care pain management|The participant post-operative pain will be managed following the standard protocol by the treating physician.
16403236|NCT04041232|Drug|PBA|Glycerol phenylbutyrate (PBA) is a triglyceride that consists of three molecules of phenylbutrate linked to a glycerol backbone. It is a nitrogen-binding agent that has been approved by the Food and Drug Administration (FDA) for the treatment of urea cycle disorders. Oral supplementation of PBA demonstrated no severe side effects, and are found to be therapeutically effective in reducing ER stress. Patients will be instructed to take three doses of PBA per day at equally divided time intervals and rounded up to the nearest 0.5 mL. The total dose of PBA will be 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day) and will not exceed 17.5 mL/day (19 g/day).
16403237|NCT04036929|Drug|Estrogen-bazedoxifene|Conjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg.
16403238|NCT04036929|Drug|Placebo oral tablet|Placebo oral tablet
16403239|NCT04032743|Other|ICU treatment|any treatment available by ICU
16403240|NCT04019444|Biological|ChAd155-RG|The ChAd155-RG Vaccine consists of a replication-defective group C ChAd, ChAd155, expressing RG under the control of the CMV promoter. The RG sequence cloned into the ChAd155 vector is a medoid, a natural viral strain with the highest average percent of amino acid identity among all RG sequences annotated in the NCBI database. The selected RG (NCBI strain AGN94271) shares an average 94% percent identity to the RGs in current vaccines.
16403241|NCT04019444|Other|Placebo|0.9% Sodium Chloride, USP injection.
16405196|NCT03841110|Drug|Nivolumab|Immune Checkpoint Inhibitor
16405197|NCT03841110|Drug|Pembrolizumab|Immune Checkpoint Inhibitor
16405198|NCT03841110|Drug|Atezolizumab|Immune Checkpoint Inhibitor
16405199|NCT03841110|Drug|Cyclophosphamide|Lympho-conditioning agent
16405200|NCT03841110|Drug|Fludarabine|Lympho-conditioning agent
16405201|NCT03841110|Drug|IL-2|Biologic response modifier
16405202|NCT03837899|Drug|Durvalumab / Tremelimumab Combination Therapy|"Starting dose:
~durvalumab: 20mg/kg tremelimumab: 1mg/kg at cycles 2 to 5 only co-administered with durvalumab. The Recommended Phase 2 dose will be used for the dose expansion phase."
16405203|NCT03837860|Drug|Oxycodone/Placebo|Oxycodone 20 mg plus placebo
16405204|NCT03837860|Drug|Oxycodone/Risperidone|Oxycodone (20mg) plus Risperidone (2 mg)
16403245|NCT04006288|Drug|Clopidogrel|Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
16403246|NCT04006288|Drug|Prasugrel|Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
16403247|NCT04006288|Drug|ticagrelor|Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
16403248|NCT04006288|Drug|aspirin|all patients will remain on aspirin
16403249|NCT04006288|Drug|rivaroxaban|Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
16403250|NCT04005859|Drug|Exparel|"2. Liposomal bupivacaine TAP block (experimental arm)
~Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
~A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
~The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
~Adhesive tapes will be applied at the level of the TAP block puncture sites."
16403251|NCT04005859|Drug|IV Lidocaine|"1. Intravenous Lidocaine infusion (control arm, current standard of care)
~100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
~1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
~Adhesive tapes will be applied at the presumed level of TAP block puncture sites."
16403252|NCT03997708|Other|Med-LFD|All participants of this group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combination of high and low FODMAPs).
16403253|NCT03997708|Other|Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS|All participants of this group will be informed to follow a diet based on the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) for Managing IBS for 4 weeks.
16403254|NCT03997435|Drug|Control arm|neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy.
16403255|NCT03997435|Drug|Experimental arm|Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy.
16403256|NCT03992404|Drug|NT 201|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16403257|NCT03992404|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16403258|NCT03989232|Drug|Semaglutide|Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
16403259|NCT03989232|Drug|Placebo (semaglutide)|Semaglutide placebo injected once-weekly from week 13 to week 40.
16403260|NCT03989206|Drug|Nemolizumab|Nemolizumab
16403261|NCT03987841|Behavioral|Integrated MBSR/DSME intervention|Integrated mindfulness-based stress reduction/diabetes self-management education intervention. The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. A trained masters-level interventionist will deliver the integrated intervention.
16403262|NCT03986424|Drug|Akatinol Memantine 20 mg|Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
16403263|NCT03986424|Drug|Akatinol Memantine 10 mg|Akatinol Memantine 10 mg to be taken orally, twice daily
16403264|NCT03982043|Behavioral|Text2Connect|Text2Connect is a personalized text messaging intervention for patients and parents that targets self-identified barriers to engaging in treatment to increase the likelihood that a depressed or suicidal patient will initiate recommended services.
16403265|NCT03980574|Dietary Supplement|R Drink|R Drink is a dietary supplement drink containing filtered reverse osmosis water and 150 mg/L of both USP Grade calcium chloride and magnesium chloride, 10 mg/L Biotin (vitamin B7), 500 mg/L of Niacinamide (B3) and 550 mg/L of Choline.
16403266|NCT03972488|Drug|Lutathera|7.4 GBq/200 mCi x 4 administrations every 8 +/- 1 weeks
16403267|NCT03972488|Drug|long-acting octreotide|30 mg every 8 weeks during Lutathera treatment and every 4 weeks after last Lutathera treatment
16403268|NCT03972488|Drug|high dose long-acting octreotide|60 mg every 4 weeks
16403269|NCT03972488|Other|Optional post-progression re-treatment with Lutathera|additional 2-4 cycles of Lutathera (7.4 GBq/200 mCi x 4 cycles)
16403270|NCT03972488|Other|Optional post-progression cross-over to Lutathera|maximum 4 cycles of Lutathera (7.4 GBq/200 mCi x 4 cycles) plus octreotide long-acting (30 mg every 8 weeks)
16403271|NCT03971422|Drug|Rozanolixizumab|Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
16403272|NCT03971422|Other|Placebo|Subjects will receive placebo at pre-specified time points.
16403273|NCT03968653|Drug|Debio 0123|Debio 0123 will be given as an oral capsule for 3 days during each 21-day cycle, except Cycle 1 which is of 24 days.
16403274|NCT03968653|Drug|Carboplatin|Carboplatin will be given as an intravenous infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards.
16403275|NCT03965897|Behavioral|Acceptance and Committment Therapy (ACT)|Overall, the goal of the ACT intervention is to cultivate psychological flexibility: to help Veterans respond to life events in ways which do not exacerbate difficulties or restrict engagement in meaningful activities. It increases patients' awareness of behaviors that exacerbate the pain (such as struggling with it) and recognition of avoidance strategies that interfere with life engagement.
16403276|NCT03965897|Other|Attention Control (AC)|Information on any other coping practices will be omitted. The group facilitators will present one topic at a time, using the Pain Manual, and the participants will discuss and reflect about issues and experiences related to each topic. If necessary, the group facilitators will raise specific discussion questions to facilitate group dialogue and participant involvement.
16403277|NCT03964727|Drug|Sacituzumab Govitecan-hziy|Administered intravenously
16404265|NCT05039710|Drug|JNJ-75220795|JNJ-75220795 will be administered as SC injection.
16403278|NCT03952767|Other|Digital Physical Measures and Survey Assessments|Data from at home and in clinic visits will assess physical function and survey data will be collected
16403279|NCT03947918|Behavioral|Short sleep|Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.
16403280|NCT03947918|Behavioral|Long sleep|Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.
16403281|NCT03940989|Other|HABIT-ILE|Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.
16403282|NCT03935321|Drug|NG-101|6 intrathecal bolus injections, each of 45mg
16403283|NCT03935321|Drug|Placebos|6 intrathecal bolus injections, each of 45mg
16403284|NCT03930745|Other|Placebo|Placebo vaginal inserts.
16403285|NCT03930745|Drug|TOL-463|TOL-463 is a non-azole vaginal anti-infective drug candidate designed as a dual-indication therapy for BV and VVC.
16403286|NCT03928704|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16403287|NCT03928704|Other|Placebo|Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.
16403288|NCT03925727|Drug|tavilermide ophthalmic solution|BID topical dosing
16403289|NCT03925727|Other|Placebo|BID topical dosing
16403290|NCT03925350|Drug|Niraparib|300 mg PO daily
16403299|NCT03922724|Drug|IOC|e-ATG40 mg/kg/day IV on days -14 and -13. Pentostatin 4 mg/m2/day IV on days -9 and -5. Cyclophosphamide 5 mg/kg orally daily on days -9 through -2
16403300|NCT03922724|Drug|GVHD prophylaxis|High-dose, post-transplantation cyclophosphamide (PTCy) on days +3 and +4 ( 25 mg/kg/day on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on days +5 through +25.
16403301|NCT03922724|Drug|RIC|e-ATG 40 mg/kg/day IV on days -14 and -13. Pentostatin 4mg /m2/day IV on days -11 and -7. Cyclophosphamide 5 mg/kg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2.
16403302|NCT03922724|Procedure|allo HCT|Stem cell transplant
16403303|NCT03922724|Drug|mRIC|e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, lowdose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, G-CSF 5 mcg/kg/day subcutaneous on days -12, -8, and -4.
16403304|NCT03922724|Drug|ATL-RIC|e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, low-dose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, G-CSF 5mcg /kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50.
16403327|NCT03907540|Drug|Belumosudil 200 mg tablet|Belumosudil 200 mg tablet, development candidate
16403328|NCT03907540|Drug|[14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose|test investigational medicinal product
16403329|NCT03907540|Drug|[14C]-KD025 200 mg capsule|test investigational medicinal product
16403330|NCT03906526|Drug|VTX-2337|Motolimod
16403332|NCT03905720|Procedure|Acupuncture|A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
16403333|NCT03905720|Behavioral|Pain Counseling|Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
16403334|NCT03897036|Drug|CX-4945|API powder-in-capsule in 200 mg strength
16403340|NCT03890731|Drug|BAY73-4506 (Regorafenib, Stivarga)|Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off).
16403341|NCT03888105|Drug|Odronextamab|Administered by intravenous (IV) infusion
16403342|NCT03879304|Other|multimodal physiotherapy program with RV|Physiotherapy Programm includes: respiratory physiotherapy, stretching, massage, resistance training, aerobic training and adaptation and training with virtual reality glasses.
16403343|NCT03879304|Other|multimodal physiotherapy program|Multimodal physiotherapy Programm includes: respiratory physiotherapy, stretching, massage, aerobic training and resistance training.
16403344|NCT03876977|Procedure|Robotic laparoscopic decompression of pudendal nerve entrapment|"Robotic laparoscopic decompression of pudendal nerve entrapment.
~Transperitoneal Laparoscopic Robotic assistance"
16403345|NCT03869216|Behavioral|Educational Shared Decision-Making Intervention|The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the AHRQ SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.
16403348|NCT03864965|Other|Advance Care Planning|The provider will guide advance care planning conversations with patients identified with mild or moderate dementia during their third office visit, approximately three months after the first visit.
16403349|NCT03861780|Drug|Project X 26ml|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403350|NCT03861780|Drug|Project X 5.1ml|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403351|NCT03861780|Drug|Prevantics Maxi Swabstick|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403352|NCT03859414|Drug|Therapeutic Dose 1|CHF 5993 100/6/12.5 µg pMDI, fixed combination of BDP 100 µg + FF 6 µg + GB 12.5 µg.
16403353|NCT03859414|Drug|Therapeutic Dose 2|CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.
16403354|NCT03859414|Drug|Supra-therapeutic Dose|CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.
16403355|NCT03859414|Drug|Placebo|CHF 5993 placebo pMDI
16403356|NCT03834220|Drug|Debio 1347|80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.
16403357|NCT03833700|Drug|E7386|E7386, tablets, orally.
16403358|NCT03830333|Drug|Ceftolozane/Tazobactam|Ceftolozane 1000 mg / tazobactam 500 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive ceftolozane 500 mg / tazobactam 250 mg.
16403359|NCT03830333|Drug|Metronidazole|Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days.
16403360|NCT03830333|Drug|Meropenem|Meropenem 1000 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive IV infusion every 12 hours.
16403361|NCT03830333|Drug|Placebo|Saline by IV infusion every 8 hours for 4 to 14 days.
16403362|NCT03829332|Biological|Pembrolizumab|IV infusion
16403363|NCT03829332|Drug|Lenvatinib|oral capsule
16403364|NCT03829332|Drug|Placebo for lenvatinib|oral capsule
16403365|NCT03818971|Other|electroretinogram (flash, pattern and multifocal)|we measured the waves a, b, oscillatory potentials, back ground noise and i for the flash ERG, the waves P50 and N95 for the pattern ERG and the P1, N1 and N2 for the multifocal ERG
16403366|NCT03817814|Behavioral|web-based questionnaire|Participants will complete a web-based questionnaire examining the decisions patients made about fertility preservation before and after treatment, the factors that influenced their decisions, and the ways in which patients pursue family building after treatment.
16403367|NCT03817580|Drug|Project X 26ml|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403368|NCT03817580|Drug|Project X 5.1ml|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403369|NCT03817580|Drug|Prevantics Maxi Swabstick|Application of antiseptic drug to the inguinal and abdomen areas of the subjects
16403370|NCT03805789|Biological|Alpha-1 antitrypsin (AAT)|Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
16403371|NCT03805789|Biological|Placebo|Albumin solution administered intravenously
16403372|NCT03798626|Drug|Gevokizumab|60 mg/mL concentration; administered intravenously (IV)
16403373|NCT03798626|Drug|Bevacizumab|25 mg/mL concentration; administered IV
16403374|NCT03798626|Drug|Modified FOLFOX6|Oxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
16405456|NCT03055013|Other|Questionnaire Administration|Ancillary studies
16405457|NCT03030534|Combination Product|Educational package and software package|Using Information and communication technology to deliver health promoting activities
16405458|NCT03030534|Other|Health promotion tips|Give general information on health promotion
16403375|NCT03798626|Drug|FOLFIRI|Irinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
16403376|NCT03798626|Drug|Ramucirumab|10 mg/mL concentration; administered IV
16403377|NCT03798626|Drug|Paclitaxel|6 mg/mL concentration; administered IV
16403378|NCT03798626|Drug|Cabozantinib|60 mg tablet; administered orally
16403379|NCT03797378|Other|eM2M|The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability.
16403380|NCT03794999|Drug|Benralizumab-exposure|Exposure is defined as any dose of benralizumab for any length of time from 8 weeks prior to Last Mentrual Period (LMP) through the end of pregnancy, as reported by the mother and validated through medical record review. The 8-week cut-off prior to LMP is based upon the terminal half-life of benralizumab of approximately 15 days (clearance of benralizumab is based on five half-lives).
16403381|NCT03794999|Drug|Exposure to other asthma medications|Exposure to asthma medications for any number of days, at any dose, and at any time from LMP up to the date of enrollment, but no exposure to benralizumab during pregnancy or within 8 weeks prior to LMP.
16403382|NCT03789604|Biological|CS1001 monoclonal antibody|Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle
16403383|NCT03789604|Biological|CS1001 placebo|Participant will receive CS1001 placebo 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle
16403386|NCT03781297|Other|Narrative Exposure Therapy|Narrative Exposure Therapy attempts to place the trauma within a narrative of the person's life. Anecdotal evidence of using this approach in the homeless population is that constructing an autobiography helps to give meaning to their problems and provide the initial steps in constructing a core sense of belonging and identity. Six sessions of individual therapy allows for participants to work with a therapist one-on-one to position their experiences of trauma within their life story.
16403387|NCT03781297|Other|Genealogical Services|At the start of their involvement in the, study participants randomized to this group will be provided with the option to access services from a professional genealogist, to trace their family history. Participants will be made aware of the fact that new family information will be revealed through this process, and also be informed of the standard methods that will be used to extract this information which could involve research through publicly available historical records or voluntary DNA testing.
16403388|NCT03761277|Device|Medtronic SynchroMed™ II infusion system|Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).
16403389|NCT03761277|Drug|Preservative-free morphine sulfate (PFMS)|The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
16403390|NCT03752177|Drug|LY3415244|Administered IV
16403391|NCT03746002|Drug|Metolazone 60 minutes prior to furosemide|All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
16403392|NCT03746002|Drug|Metolazone concurrently with furosemide|All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
16403397|NCT03734107|Behavioral|Plan, Reflect, and Engage with Providers for Diabetes Care|Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
16403400|NCT03729596|Biological|MGC018|Anti-B7-H3 antibody drug conjugate
16403401|NCT03729596|Biological|MGA012|Anti-PD-1 antibody
16403411|NCT03723551|Drug|Afabicin (Part A)|Afabicin will be given IV at a dose 160 mg BID for a minimum of 1 day (2 doses) and up to a maximum of 14 days (2 weeks), followed by a switch to oral Afabicin at a dose of 240 mg BID for the remaining treatment duration.
16403412|NCT03723551|Drug|Standard of Care|Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
16403413|NCT03723551|Drug|Afabicin (Part B)|Participants will be administered with open label afabicin intravenous (IV) at a dose of 55 milligrams (mg) twice daily (BID) for a minimum of 1 day (2 doses) and up to a maximum of 14 days (2 weeks) followed by a switch to oral Afabicin at a dose of 80 mg BID for the remaining treatment duration. In certain study conditions a higher dosing regimen of afabicin might be used: afabicin intravenous (IV) at a dose of 80 mg BID for a minimum of 1 day (2 doses) and up to a maximum of 14 days (2 weeks) followed by a switch to oral Afabicin at a dose of 120 mg BID for the remaining treatment duration.
16403414|NCT03723265|Device|Cardiac Resynchronization Therapy|
16403415|NCT03691779|Drug|ELX/TEZ/IVA|Fixed-dose combination tablet orally once daily in the morning.
16403416|NCT03691779|Drug|IVA|IVA tablet orally once daily in the evening.
16403417|NCT03685175|Drug|Formal study using hyperpolarized 13C-pyruvate injection|Administration at two visits 1) after completion of cardiotoxic therapy and 2) 1 to 6 months after the first time point following medical therapy (SOC)
16403418|NCT03685175|Drug|Feasible study using hyperpolarized 13C-pyruvate injection|Administration at two visits: 1) baseline MRI before administration of cardiotoxic therapy and 2) after completion of cardiotoxic therapy
16403419|NCT03654638|Combination Product|Dietary Intervention|The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
16403420|NCT03654638|Combination Product|Dietary Intervention|The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
16403421|NCT03654638|Other|Questionnaire Administration|Ancillary studies
16403422|NCT03652051|Drug|AZR-MD-001 Low Dose|AZR-MD-001 is an ophthalmic ointment
16403423|NCT03652051|Drug|AZR-MD-001 Mid Dose|AZR-MD-001 is an ophthalmic ointment
16403424|NCT03652051|Drug|AZR-MD-001 High Dose|AZR-MD-001 is an ophthalmic ointment
16403425|NCT03652051|Drug|AZR-MD-001 Vehicle|AZR-MD-001 is a vehicle ophthalmic ointment
16403426|NCT03637660|Drug|Benzathine Penicillin|BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.
16403427|NCT03635086|Biological|MV-CHIK lyophilised formulation, low dose|MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
16403428|NCT03635086|Biological|MV-CHIK liquid frozen formulation, low dose|MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
16403429|NCT03635086|Biological|MV-CHIK SPS® formulation, low dose|MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
16403430|NCT03635086|Biological|MV-CHIK liquid frozen formulation, high dose|MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
16403431|NCT03635086|Other|Placebo|Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
16403432|NCT03633058|Drug|Ketamine|oral ketamine dosed twice daily for 5 days
16403433|NCT03628235|Behavioral|Online survey|Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
16403434|NCT03621982|Drug|ADCT-301|intravenous infusion
16403435|NCT03621982|Biological|Pembrolizumab|intravenous infusion
16403436|NCT03617562|Procedure|Superior Capsular Reconstruction|Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.
16403437|NCT03617562|Procedure|Partial Repair|Rotator cuff is repaired with residual defect remaining.
16403438|NCT03600701|Drug|Atezolizumab|Given IV
16403439|NCT03600701|Drug|Cobimetinib|Given PO
16403440|NCT03596866|Drug|Brigatinib|Brigatinib Tablets.
16403441|NCT03596866|Drug|Alectinib|Alectinib Capsules.
16403445|NCT03575208|Biological|hepatitis B immune globulin (HBIg)|HBIg 20,000 U/L iv. Dosing interval will depend on anti-HBs levels.
16403446|NCT03575208|Drug|Pegylated interferon alfa (pegIFN)|peginterferon alfa-2a 180 mcg weekly for 24 weeks
16403447|NCT03573414|Other|raspberry powder, milled flaxseed and soy milk|"The participants will consume a breakfast consisting of 30 g of milled flaxseed, 40 g of raspberry powder and 250 ml of soy milk for 3 days
~The participants will provide blood and urine samples"
16403448|NCT03568994|Drug|Atovaquone|"Patients will receive standard of care MRC based Induction chemotherapy (such as ADE 10+3+5 with daily atovaquone dosing starting on day 6. In order to accommodate potential drug shortages modifications to ADE 10+3+5 that retain the MRC based induction backbone regimen of DA are allowed (see second Arm). These include but are not limited to substitution of etopophos for etoposide, exclusion of etoposide, use of CPX-351 (VYXEOS (daunorubicin and cytarabine) liposome) only, and daunorubicin and cytarabine (DA) + gemtuzumab ozogamicin (GO).
~Patients will be monitored for adherence to and tolerance of daily dosing of atovaquone. Peripheral blood (PB) and bone marrow plasma samples will be obtained to measure atovaquone concentrations."
16403449|NCT03568994|Drug|Cytarabine|As part of routine Induction 1 chemotherapy (ADE 10+3+5)
16403450|NCT03568994|Drug|Daunorubicin|As part of routine Induction 1 chemotherapy (ADE 10+3+5)
16403451|NCT03568994|Drug|Etoposide|As part of routine Induction 1 chemotherapy (ADE 10+3+5)
16403452|NCT03568994|Drug|Gemtuzumab Ozogamicin|As part of routine Induction 1 chemotherapy(DA 3+10 + GO)
16403453|NCT03568929|Drug|Idelalisib|Tablets administered according to the product information and treatment guidelines in routine clinical practice
16404266|NCT05039710|Other|Placebo|Matching placebo will be administered as SC injection.
16403454|NCT03560102|Device|Philips Sonalleve® MR-HIFU Breast Therapy System|The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
16403455|NCT03555422|Drug|Selinexor|Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
16403456|NCT03555422|Drug|Matching placebo for selinexor|Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
16403457|NCT03552198|Behavioral|Alternative health advice|These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations.
16403458|NCT03542175|Drug|Rucaparib|one dose level (300 mg BID, 400 mg BID, 500 mg BID or 600 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
16403459|NCT03542175|Radiation|Radiotherapy|50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
16403460|NCT03541174|Drug|Aprocitentan 12.5 mg|Tablet, oral use
16403461|NCT03541174|Drug|Aprocitentan 25 mg|Tablet, oral use
16403462|NCT03541174|Drug|Placebo|Matching placebo tablet
16403465|NCT03528447|Other|Pulmonary Rehabilitation|"Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities.
~Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session.
~Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band."
16403466|NCT03522064|Drug|Testosterone Enanthate 100 MG/ML Injectable Solution|Testosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL.
16403467|NCT03522064|Drug|Testosterone Enanthate 100 MG/ML Injectable Solution / Carboplatin AUC 5|Testosterone Enanthate is the oil-soluble ester of the androgenic hormone testosterone. Testosterone Enanthate is a clear to pale yellow solution for intramuscular injection. Each pre-filled syringe contains 250mg testosterone enanthate/1mL. Carboplatin as per standard procedures
16403468|NCT03521154|Drug|Osimertinib 80mg/40mg|The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16403469|NCT03521154|Drug|Placebo Osimertinib 80mg/40mg|"The initial dose of Placebo Osimertinib 80mg once daily can be reduced to 40mg once daily.
~Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met"
16403470|NCT03511638|Device|Bausch & Lomb DVisc40|Ophthalmic viscosurgical device
16403471|NCT03511638|Device|Alcon VISCOAT®|Ophthalmic viscosurgical device
16403472|NCT03509974|Device|Osseointegrated Steady State Implant|Bone anchored, bone conduction hearing system
16403473|NCT03506971|Other|Psychologist's evaluation|The research coordinator psychologist will evaluate: the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity.
16403474|NCT03506971|Other|Pediatric Nurse's interventions|"Pediatrics nurses perform preventive home visits that are based on : joint observation with the parents of the baby, play with the baby and his parents, interview with the parents on their parenthood
~Rhythm of home visits:
~1 every month from birth to 1 year
~1 every 2 months from 1 year to 2 years
~1 every 3 months from 2 years to 4 years"
16403475|NCT03506971|Other|Joint home visits|"Coordinating psychologist and the referent pediatric nurse will perform home visits. During this time, the psychologist evaluate : the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity.
~Rhythm of joint home visits:
~1 at 4 months
~1 at 24 months"
16403476|NCT03499236|Device|V-Wave Interatrial Shunt|The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
16403477|NCT03499236|Other|Control|Right heart catheterization, invasive echocardiography.
16403480|NCT03484273|Device|LifeWrap Compression Garment|Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.
16403481|NCT03484143|Device|Active Neuro RX Gamma device|Twenty minute treatment session, 6 days a week for 24 weeks
16403482|NCT03484143|Device|Sham Neuro RX Gamma device|Twenty minute treatment session, 6 days a week for 24 weeks
16403483|NCT03476681|Drug|NEO-201 in combination with pembrolizumab|NEO-201 will be given intravenously every 2 weeks in combination with pembrolizumab. In each cycle subjects will receive 3 doses of NEO 201 and one dose of pembrolizumab.
16403484|NCT03465982|Procedure|Surgery after 8 weeks from chemoradiation treatment|Minimally invasive surgery after 8 weeks from chemoradiation treatment
16403485|NCT03465982|Procedure|Surgery after 12 weeks from chemoradiation treatment|Minimally invasive surgery after 12 weeks from chemoradiation treatment
16403488|NCT03442569|Drug|Panitumumab|6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
16403489|NCT03442569|Drug|Nivolumab|240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
16403490|NCT03442569|Drug|Ipilimumab|1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
16403491|NCT03441360|Drug|Eribulin mesylate|Intravenous infusion
16403492|NCT03437330|Drug|Empagliflozin (Jardiance®)|Empagliflozin Dose/frequency: 10 mg once daily for 12 weeks Route of administration: oral Reference group: Insulin glargine (Lantus®) Dose/frequency: see below FBG 6-7 mmol/L: +2 IU (stop when FBG is reduced by 0.5 mmol/L or documented hypoglycemia < 3.9 mmol/L occurs) FBG 7-8 mmol/L: +4 IU (stop when FBG is reduced by 1.0 mmol/L or documented hypoglycemia < 3.9 mmol/L occurs) FBG > 8 mmol/L: +6 IU (stop when FBG is reduced by 1.5 mmol/L or documented hypoglycemia < 3.9 mmol/L occurs)
16403493|NCT03437330|Drug|Insulin Glargine (Lantus®)|"insulin glargine shall be titrated according to the following scheme: If FBG 6-7 mmol/L: reduce fasting glucose by 0.5 mmol/L If FBG 7-8 mmol/L: reduce fasting glucose by 0.75 mmol/L
~If FBG 8-9 mmol/L: reduce fasting glucose by 1.0 mmol/L Thus, insulin glargine doses should be adapted as follows:
~FBG 6-7 mmol/L: +2 IU (stop when FBG is reduced by 0.5 mmol/L or documented hypoglycemia < 3.9 mmol/L occurs) FBG 7-8 mmol/L: +3IU (stop when FBG is reduced by 0.75 mmol/L or documented hypoglycemia < 3.9 mmol/L occurs) FBG > 8 mmol/L: +5 IU (stop when FBG is reduced by 1.0mmol/L or documented hypoglycemia < 3.9 mmol/L occurs)"
16403494|NCT03419481|Drug|pembrolizumab|200mg every 3 weeks infusion
16403495|NCT03409991|Behavioral|Opening Doors|This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention for individuals with psychiatric disabilities. We are using both a randomized clinical trial design coupled with a small qualitative sub-study.
16403496|NCT03408652|Drug|denosumab|Single subcutaneous injection of denosumab 120 mg every 4 weeks One intravenous infusion of zoledronic acid 4 mg every 4 weeks, according to labelled use.
16403497|NCT03407495|Drug|IOP Injection (MPB-1523)|one dose, once IV injection at Day 1
16403501|NCT03390842|Drug|TRC101|Oral suspension
16403502|NCT03390842|Drug|Placebo|Oral suspension
16403503|NCT03379727|Drug|Midostaurin|Orally administered inhibitor of multiple tyrosine kinases
16403504|NCT03372941|Drug|Dalbavancin|Dalbavancin, a lipoglycopeptide antibiotic, has been approved by the FDA for the treatment of ABSSSI caused by Gram-positive bacteria. A single dose of dalbavancin will be administered in the Emergency Department followed by discharge with close outpatient infectious disease clinic follow-up.
16403505|NCT03366844|Drug|Pembrolizumab|checkpoint inhibitor
16403506|NCT03366844|Radiation|RT Boost|The second dose of pembrolizumab will be given in conjunction with an RT boost, consisting of 8 Gy for 3 fractions.
16403507|NCT03366545|Device|Cardiac Resynchronization Therapy (CRT)|Observation and documentation of routine care for CRT patients
16403508|NCT03355573|Drug|Bimekizumab|Bimekizumab at a prespecified dose.
16403509|NCT03352778|Radiation|IMRT|66Gy by intensity-modulated radiotherapy
16403510|NCT03352778|Radiation|2DRT|66Gy by 2-dimensional radiotherapy
16403511|NCT03340844|Procedure|No Touch (NT)|Tumor resection by No-touch technique: dissection of hepatic hilum, dissection of superior mesenteric vein (SMV) in caudal aspect of pancreas, section of antrum, pancreatic neck section. Section-ligation of veins of duodenopancreatectomy part of SMV and portal. Then Kocher-uncrossing maneuver of the jejunal loop and final section of the retro-portal (back of the portal vein) blade.
16403512|NCT03340844|Procedure|Superior Mesenteric Artery First (SMA)|Tumor resection by SMA technique: Kocher maneuver extends to the left renal vein (LRV). Dissection above the LRV of the SMA (refer to vessel-loop). Then, SMA will be identified on the caudal side of the pancreas (mesenterial root) and progressive dissection until its origin in the aorta artery (previously referenced with vessel loop).
16403513|NCT03339141|Procedure|Intubation position|The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).
16403518|NCT03318861|Genetic|KITE-585|A single infusion of KITE-585 autologous anti-BCMA CAR T cells
16403519|NCT03318861|Drug|Cyclophosphamide|Administered intravenously
16403520|NCT03318861|Drug|Fludarabine|Administered intravenously
16403521|NCT03301506|Drug|Seladelpar 5 mg Capsule|Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.
16403522|NCT03301506|Drug|Seladelpar 10 mg Capsule|Subjects will be assigned to a treatment group unless there are tolerability issues.
16403523|NCT03301415|Drug|Valganciclovir|Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
16403524|NCT03292861|Drug|Thymoglobulin|Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 8 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4-8 hours.
16403967|NCT05092360|Drug|Paclitaxel|80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
16403525|NCT03292861|Drug|Mycophenolate Mofetil|3.0 grams divided bid begun post-transplant, either IV or po as tolerated by patient. Initial dose must be given within 24 hours post-transplant. Dosing will be titrated based on recipient's body size and any adverse side effects
16403526|NCT03292861|Drug|Tacrolimus|Doses of 1-4 mg bid either IV or po will be prescribed to achieve a target trough level of 10-15 ng/mL before post-operative day number 5. Target trough levels are 10-15 ng/mL for post-operative days #1-30, 8-12ng/mL days#31-60 and 5-10 ng/mL thereafter.
16403527|NCT03292861|Drug|Sirolimus|Maintenance doses of sirolimus at 12 months post-transplantation
16403528|NCT03292861|Drug|Corticosteroids|125 mg IV methylprednisolone immediately post-operatively x 3 doses q12hrs, then switching to oral prednisone at 1.0 mg/kg/day po divided into bid doses that are rounded off to the next higher 5 mg increment. For example, a 76 kg person would should be dosed at 38 mg po bid, which rounded off to the next 5 mg increment would be 40 mg po bid. (Equivalent dosing via an alternative route may be used if pos not tolerated or contraindicated). Prednisone will be tapered by 10 mg qd until the dose of 10 mg po bid is reached.
16403529|NCT03288363|Device|tDCS|20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)
16403530|NCT03270176|Drug|Debio 1143|Debio 1143 100 to 250 mg, capsule orally for 10 days every 2 weeks.
16403531|NCT03270176|Drug|Avelumab|Avelumab 10 mg/kg intravenous infusion every 2 weeks.
16403533|NCT03265496|Procedure|Clinical exam|Clinical exam is performed before treatment start
16403534|NCT03265496|Procedure|Liquid biopsy|Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease
16403535|NCT03265496|Procedure|Diagnostic exam|Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.
16403536|NCT03265496|Drug|1st line treatment|1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.
16403537|NCT03265496|Procedure|tumor evaluation|Tumor evaluation will be performed every 3 cycles of chemotherapy
16403538|NCT03265496|Biological|Biopsy|Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.
16403539|NCT03263637|Drug|AZD4573|AZD4573 will be administered as a intravenous (IV) infusion.
16403540|NCT03263117|Drug|Sedation|"The protocol does not specify a particular combination of drugs that must be used for sedation.
~The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist."
16403541|NCT03263117|Drug|General Anesthesia (GA)|"The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
~The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)"
16403542|NCT03263117|Procedure|Intra-arterial Thrombectomy|The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
16403545|NCT03246425|Other|Ventilator mode change|The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed
16403546|NCT03246425|Device|Monitoring of blood pressure variation|The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor
16403548|NCT03215030|Drug|TAK-573|TAK-573 intravenous infusion.
16403549|NCT03215030|Drug|Dexamethasone|Dexamethasone.
16403550|NCT03197090|Device|Zenicor ECG|Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
16403551|NCT03196284|Drug|Concizumab|A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase
16403552|NCT03196284|Drug|Eptacog alfa|A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms
16403553|NCT03189524|Drug|Zanubrutinib|Zanubrutinib is a white to off-white solid that is slightly hygroscopic. The drug product was formulated as 20-mg (blue, size 3) and 80-mg (white, size 0) hard gelatin, opaque oral capsules. Zanubrutinib is classified as a Biopharmaceutics Classification System Class II compound.
16404023|NCT05091840|Other|oximetry monitoring|monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
16403554|NCT03187119|Behavioral|Pictorial Asthma Action Plan|Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP.
16403555|NCT03187119|Behavioral|Written Asthma Action Plan|Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP.
16403556|NCT03182907|Biological|Bezlotoxumab|A single intravenous (IV) infusion of 10 mg of bezlotoxumab per kg body weight. Dose may then be changed based on results from initial 12 participants.
16403557|NCT03182907|Drug|Placebo|A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.
16403558|NCT03181035|Radiation|(18)F-Fluoroazomycin arabinoside|FAZA PET diagnostic testing
16403559|NCT03181035|Drug|Pimonidazole|oral pimonidazole hypoxia labeling
16403563|NCT03165994|Drug|APX005M|APX005M intravenous (IV) infusion
16403564|NCT03165994|Radiation|Radiation Therapy|Radiation therapy, total dose 5040cGy in 180cGy fractions
16403565|NCT03165994|Drug|Paclitaxel|Paclitaxel IV infusion
16403566|NCT03165994|Drug|Carboplatin|Carboplatin IV infusion
16403567|NCT03165994|Procedure|Surgical resection of tumor|Surgical removal of the tumor will occur between weeks 10-16
16403568|NCT03139721|Device|Mosaic model 305, model 310, and ultra model 305|Aortic or mitral valve replacement
16403569|NCT03135834|Biological|MenABCWY|N meningitidis group A, B, C, W, and Y vaccine
16403570|NCT03135834|Biological|Saline|Placebo
16403571|NCT03135834|Biological|rLP2086|Bivalent recombinant lipoprotein 2086 vaccine
16403572|NCT03135834|Biological|MenACWY-CRM|meningococcal group A, C, W-135, and Y conjugate vaccine
16403573|NCT03127904|Procedure|Vein Fitness|Vein fitness is a combination of whole-limb exercises, manual lymphatic drainage, and usual care (wound care and compressive therapy).
16403574|NCT03127904|Procedure|Compressive therapy and wound care|"Compressive therapy consists in the application of pressure to the inferior limb. Investigators describe the specifics in the arm section.
~As previously described, a trained nurse will be in charge of keeping the wound healthy, verifying the surface is clean, debriding it, and removing biofilm from it."
16403575|NCT03119610|Drug|Oxytocin nasal spray|Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
16403576|NCT03119610|Drug|Placebo nasal spray|Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
16403577|NCT03101241|Drug|CX-8998|T-type calcium channel blocker
16403578|NCT03101241|Drug|Placebo|Placebo comparator
16403579|NCT03056755|Drug|alpelisib|300 mg; oral; once daily
16403580|NCT03056755|Drug|fulvestrant|500 mg; intramuscular injection on Days 1, 15 on Cycle 1 and Day 1 at each cycle thereafter
16403581|NCT03056755|Drug|letrozole|2.5 mg; oral; once daily
16403582|NCT03056755|Drug|Goserelin|Every 28 days (only for men in cohort B and premenopausal women). Administered as injectable subcutaneous implant (3.6 mg)
16403583|NCT03056755|Drug|Leuprolide|Every 28 days (only for men in cohort B and premenopausal women). Administered as injectable intramuscular depot (7.5 mg)
16403584|NCT03030261|Drug|Elotuzumab|During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.
16403585|NCT03030261|Drug|Pomalidomide|During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.
16403586|NCT03030261|Drug|Dexamethasone|During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.
16403588|NCT03007758|Procedure|open ventral hernia repair|An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.
16403589|NCT03007758|Procedure|robotic ventral hernia repair|A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.
16403590|NCT03000439|Drug|In open-label phase: treatment with tofacitinib|Treatment with investigational drug
16403591|NCT03000439|Drug|In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio|Treatment with investigational drug or placebo
16403592|NCT02990481|Biological|TRK-950|Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
16403593|NCT02990481|Biological|TRK-950|"Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
~High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle"
16403594|NCT02990481|Biological|TRK-950|Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
16403595|NCT02989246|Other|Ventilator protocol|Open loop ventilator management by a computer based protocol
16403596|NCT02989246|Device|Esophageal Catheter|Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
16403598|NCT02979522|Drug|Brentuximab vedotin|Brentuximab vedotin infusion
16403599|NCT02979522|Drug|Doxorubicin|Doxorubicin infusion
16403600|NCT02979522|Drug|Vinblastine|Vinblastine infusion
16403601|NCT02979522|Drug|Dacarbazine|Dacarbazine infusion
16403602|NCT02969850|Dietary Supplement|Vitamin D Supplementation|Subjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level.
16403603|NCT02969850|Other|Placebo|Subjects in this group will receive a placebo.
16403604|NCT02969850|Dietary Supplement|Calcium|If dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day.
16403605|NCT02955290|Other|Laboratory Biomarker Analysis|Correlative studies
16403606|NCT02955290|Biological|Nivolumab|Given IV
16403607|NCT02955290|Biological|Pembrolizumab|Given IV
16403608|NCT02955290|Biological|Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine|Given CIMAvax IM
16403609|NCT02953509|Drug|Magrolimab|Administered intravenously
16403610|NCT02953509|Drug|Rituximab|Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13
16403611|NCT02953509|Drug|Gemcitabine|Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
16403612|NCT02953509|Drug|Oxaliplatin|Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
16403613|NCT02947386|Other|Laboratory Biomarker Analysis|Correlative studies
16403614|NCT02947386|Biological|Nimotuzumab|Given IV
16403615|NCT02947386|Biological|Nivolumab|Given IV
16403616|NCT02939989|Drug|Sofosbuvir|Tablet
16403617|NCT02939989|Drug|ABT-493/ABT-530|Tablet
16403618|NCT02939989|Drug|Ribavirin|Tablet
16403619|NCT02932150|Drug|TAF|Administered orally once daily
16403620|NCT02932150|Drug|Placebo|Administered orally once daily
16403621|NCT02924376|Drug|Pemigatinib|Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
16403622|NCT02923167|Device|Robotic-assisted training of the hand|Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
16403623|NCT02921256|Drug|Capecitabine|Given PO
16403624|NCT02921256|Drug|Fluorouracil|Given IV
16403625|NCT02921256|Radiation|Intensity-Modulated Radiation Therapy|Undergo intensity modulated radiation therapy
16403626|NCT02921256|Drug|Leucovorin|Given IV
16403627|NCT02921256|Drug|Oxaliplatin|Given IV
16403628|NCT02921256|Biological|Pembrolizumab|Given IV
16403629|NCT02921256|Drug|Veliparib|Given PO
16403630|NCT02914600|Drug|Filgotinib|Tablet(s) administered orally once daily
16403631|NCT02914600|Drug|Placebo|Tablet(s) administered orally once daily
16403632|NCT02895100|Drug|PTG-100|Daily dosing of PTG-100 by subject for a 12 week treatment period.
16403633|NCT02895100|Drug|Placebo|Daily dosing of Placebo capsules by subject for a 12 week treatment period.
16403634|NCT02856412|Other|Veterans Group Exercise (VGX)|Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.
16403635|NCT02856412|Other|Illness Management and Recovery|Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
16403636|NCT02837432|Drug|Hydrocortisone acetate|
16403637|NCT02837432|Drug|Placebo|
16403647|NCT02804230|Device|MRgFUS Ablation of Epileptic Foci|MR-Guided Focused Ultrasound
16404555|NCT04839354|Other|Normal saline|Placebo (normal saline) loading dose (2ml/kg IV) + 1ml/kg IV TID
16403648|NCT02788227|Biological|rVSV-Zebov GP vaccine|primary vaccination for all participants, one-to-one randomization at Month 18 to receive booster vaccination or no booster.
16403653|NCT02769273|Device|Percutaneous Transluminal Angioplasty|
16403654|NCT02759458|Device|Smith & Nephew Healicoil Anchor|
16403655|NCT02759458|Device|Smith & Nephew Twinfix Anchor|
16403656|NCT02738398|Radiation|FDG PET/CT|
16403657|NCT02736968|Drug|Auranofin|Auranofin is a gold-containing chemical salt available as 3mg capsules
16403658|NCT02736968|Other|Placebo|Placebo
16403659|NCT02736474|Drug|Naltrexone|3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.
16403660|NCT02736474|Drug|Placebo Naltrexone|Placebo Naltrexone created and masked by the pharmacy to be used as a control.
16403661|NCT02736474|Drug|Bupropion|1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.
16403662|NCT02736474|Drug|Placebo Bupropion|Placebo Bupropion created and masked by the pharmacy to be used as a control.
16403663|NCT02735746|Radiation|4D Computed Tomography (CT)|The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.
16403664|NCT02735746|Radiation|Cone Beam CT|Daily cone beam CT imaging at each radiation treatment visit, as part of standard care
16403665|NCT02735746|Radiation|Low-dose Cinefluorography|A series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions.
16403666|NCT02735746|Device|Pulmonary Function Tests|"Pulmonary Function Testing (PFT) gives global functional data for the lungs as a whole, but is relatively insensitive to early pathological changes. It involves taking very deep breaths and exhaling as forcefully as possible.
~Research PFTs will be conducted at 4 and 12-months post radiation therapy"
16403668|NCT02658656|Device|ReWalk 6.0|Exoskeletal Assisted Walking Device
16403669|NCT02655393|Dietary Supplement|AMAZ-02|
16403670|NCT02649946|Device|Covera Vascular Covered Stent following PTA|Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
16403671|NCT02649946|Procedure|Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon|Treatment of stenoses with PTA only
16403672|NCT02649790|Drug|KPT-8602|Participants will receive KPT-8602 oral tablets.
16403673|NCT02649790|Drug|ASTX727|ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine.
16403674|NCT02649790|Drug|Dexamethasone|Participants will receive dexamethasone oral tablets.
16403675|NCT02640248|Device|Cuff ETT|
16403678|NCT02637934|Drug|[18F]FluorThanatrace|
16403679|NCT02637934|Radiation|PET/CT imaging sessions|
16403680|NCT02625480|Biological|Brexucabtagene Autoleucel (KTE-X19)|
16403681|NCT02625480|Drug|Fludarabine|Administered intravenously
16403682|NCT02625480|Drug|Cyclophosphamide|Administered intravenously
16403683|NCT02610023|Other|Questionnaire Administration|Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT
16403684|NCT02610023|Other|Laboratory Biomarker Analysis|Correlative studies
16403685|NCT02610023|Device|Spectroscopy|Undergo resonance Raman spectroscopy
16403686|NCT02603328|Drug|Atorvastatin|40-80 mg OD
16403687|NCT02603328|Other|Placebo|inactive
16403688|NCT02595996|Drug|Propranolol|escalating doses of propranolol from 1mg/kg/day to 2mg/kg/day to 3mg/kg/day
16403689|NCT02594124|Drug|nusinersen|Administered by intrathecal (IT) injection
16403690|NCT02570984|Drug|Omalizumab|anti-ige injection
16403691|NCT02570984|Drug|Placebo|placebo comparator arm, injection similar to active
16403692|NCT02564900|Drug|DS-8201a (FL-DP1)|DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (50 mg/2.5 mL) to be administered via intravenous (IV) dose. DS-8201a (FL-DP1) was used for the Dose Escalation phase and for Dose expansion Parts 2a, 2b, 2c, and 2d.
16403693|NCT02564900|Drug|DS-8201a (FL-DP2)|DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered via intravenous (IV) dose. DS-8201a (FL-DP2) was used only used for Dose Expansion Part 2e.
16403694|NCT02564744|Drug|Debio 1562|Safety run in: Debio 1562 will be given on the same day as rituximab, once every three weeks (Q3W) intravenously (IV) at the dose of 0.7 mg/kg on Day 1 of a 21-day cycle. Part 2 and 3: Cohort A- Debio 1562 will be given on the same day as rituximab, once every three weeks (Q3W) intravenously (IV) at the dose of 0.7 mg/kg on Day 1 of a 21-day cycle. Cohort B- Debio 1562 will be given at a total dose of 0.8 milligram per kilogram (mg/kg) IV over a 21-day cycle.
16403695|NCT02564744|Drug|Rituximab|Rituximab will be given on the same day as Debio 1562, Q3W IV at a dose of 375 mg/m^2 on Day 1 of a 21-day cycle.
16403704|NCT02422524|Drug|PA-824|Pretomanid (PA-824) is a nitroimidazooxazine. All subjects will receive a single oral dose of 200 mg Pretomanid on day 1.
16403705|NCT02385240|Drug|Brimonidine Topical Gel, 0.33 percent (Perrigo)|
16403706|NCT02385240|Drug|Brimonidine Topical Gel, 0.33 percent (Reference)|
16403707|NCT02385240|Drug|Placebo gel|
16403708|NCT02384551|Other|Dietary Carbohydrate|9 week menu of dietary carbohydrate modification
16403709|NCT02379572|Device|iMRI-guided surgery|For iMRI-guided glioma resections the surgery can be paused and a direct intraoperative resection control is possible by performing an intraoperative MRI scan. If residual tumor is found, the resection might be continued.
16403710|NCT02379572|Drug|5-ALA-guided surgery|For 5-ALA guided glioma resections patients have to drink 100ml of a solution with 5-Aminolevulinic acid 4-6 hours before surgery. Intraoperatively the light source of the surgical microscope can be switched to a certain wave length to enable fluorescence of the glioma cells, which helps resecting the tumor as radical as possible.
16403711|NCT02356757|Behavioral|Personalized Behavioral Intervention|The PBI is based on self-regulation theory, the Transtheoretical Model and Prospect Theory, and will be delivered using Motivational Interviewing principles and the teach-back method. Participants will receive monthly calls targeting foot self-care, foot self-monitoring, diet, medication and physical activity for 6 months. Call/mailing frequency during the next 6 months will depend on adherence level to foot self-care and self-monitoring at 6 months.
16403712|NCT02356757|Behavioral|Current Best Practice|CBP will include monthly calls from a counselor focusing on preventing conditions like colorectal cancer, flu, insomnia, vision problems, memory loss and oral disease for the first 6 months. Frequency of calls and mailings from counselors during the next 6 months will be determined by level of adherence to preventive strategies during the first 6 months.
16403720|NCT02349867|Drug|Gemcitabine|Given IV
16403721|NCT02349867|Drug|Sorafenib|Given PO
16403722|NCT02349867|Drug|Vorinostat|Given PO
16403723|NCT02349867|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D CRT
16403724|NCT02349867|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16403725|NCT02349867|Other|RosetteSep|Circulating tumor cells (CTCs) will be captured and analyzed, when detected. Pancreatic cancer has been a difficult tumor in which to detect CTCs (41). Utilization of techniques that do not require cell surface marker expression will be explored. Samples will either be analyzed by negative-selection techniques (RosetteSep). Peripheral blood samples will be collected at several time-points for CTC enumeration and to evaluate CD95 density.
16403726|NCT02349867|Other|DEPfff|Circulating tumor cells (CTCs) will be captured and analyzed, when detected. Pancreatic cancer has been a difficult tumor in which to detect CTCs (41). Utilization of techniques that do not require cell surface marker expression will be explored. Samples will either be analyzed by with the ApoStream dielectrophoretic field-flow fractionation (DEPfff) enrichment device. Peripheral blood samples will be collected at several time-points for CTC enumeration and to evaluate CD95 density.
16403727|NCT02339766|Procedure|Quadratus Lumborum Block|Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
16403728|NCT02339766|Procedure|Sham Block|Sham block of Quadratus Lumborum will be done with Saline.
16403729|NCT02339766|Drug|Intrathecal Morphine|Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
16403730|NCT02339766|Drug|Intrathecal Saline|Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.
16403731|NCT02332928|Drug|Melatonin|Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
16403732|NCT02332928|Drug|Placebo|Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
16403733|NCT02284542|Procedure|Awake|Upon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions.
16403734|NCT02284542|Procedure|Non-Awake|"The patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al.
~(Falowski et al., 2011)."
16403735|NCT02266329|Drug|prazosin hydrochloride|Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
16403736|NCT02266329|Drug|placebo|Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
16403737|NCT02265913|Drug|Acyclovir 5 percent (Perrigo)|
16403738|NCT02265913|Drug|Acyclovir 5 percent (Reference)|
16403739|NCT02265913|Drug|Placebo cream|
16403745|NCT02230696|Drug|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray|137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
16403746|NCT02230696|Drug|Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray|137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
16403747|NCT02230696|Drug|Placebo nasal spray|Placebo nasal spray
16403748|NCT02227251|Drug|Selinexor|Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
16403749|NCT02227251|Drug|Selinexor|Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
16403750|NCT02227251|Drug|Selinexor|Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
16403763|NCT02155712|Device|Triathlon Tritanium Knee|Cementless
16403764|NCT02155712|Device|Triathlon Knee|Cemented
16403765|NCT02143414|Biological|Blinatumomab|Given IV
16403766|NCT02143414|Drug|Dasatinib|Given PO
16403767|NCT02143414|Other|Laboratory Biomarker Analysis|Correlative studies
16403768|NCT02143414|Drug|Mercaptopurine|Given PO
16403769|NCT02143414|Drug|Methotrexate|Given PO
16403770|NCT02143414|Drug|Methotrexate Sodium|Given PO
16403771|NCT02143414|Drug|Prednisone|Given PO
16403772|NCT02143414|Drug|Vincristine|Given IV
16403773|NCT02143414|Drug|Vincristine Sulfate|Given IV
16403774|NCT02141919|Radiation|Stereotactic Ablative Radiation Therapy|Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
16403779|NCT02128282|Drug|CX-4945|API powder-in-capsule in 200 mg strength.
16403780|NCT02128282|Drug|Cisplatin|25 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.
16403781|NCT02128282|Drug|Gemcitabine|1,000 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.
16403784|NCT02081378|Drug|ABL001|ABL001 will be administered orally in a dose escalation schedule.
16403785|NCT02081378|Drug|ABL001 + Nilotinib|ABL001 and Nilotinib will be administered orally in CML patients
16403786|NCT02081378|Drug|ABL001|ABL001 will be administered orally in Ph+ ALL patients
16403787|NCT02081378|Drug|ABL001+imatinib|ABL001 and imatinib will be administered orally in CML patients
16403788|NCT02081378|Drug|ABL001+dasatinib|ABL001+dasatinib will be administered orally in CML patients
16403789|NCT02022098|Drug|Cisplatin|A total of three cycles of cisplatin will be administered in a 1-hour IV infusion on days 2, 23 and 44. Cisplatin will be administered 0.5 hours after Debio 1143.
16403790|NCT02022098|Radiation|Radiotherapy|Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.
16403791|NCT02022098|Drug|Debio 1143|Debio 1143 solution
16403792|NCT02022098|Drug|Placebo|Matching placebo solution
16403795|NCT01996436|Drug|Nicardipine|Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
16403796|NCT01996436|Drug|Verapamil|Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
16403797|NCT01996436|Drug|Nicardipine + Verapamil + Nitroglycerin|Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
16403798|NCT01965704|Drug|Ondansetron|Pregnant women may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. 50% of the 90 mother/baby pairs will receive ondansetron; the baby will always get the same study medication as the mother.
16403799|NCT01965704|Drug|Placebo|All doses of placebo, whether IV or oral, will mimic the same volume as the ondansetron group to maintain the blind. Pregnant women may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. 50% of the 90 mother/baby pairs will receive placebo; the baby will always receive the same study medication as the mother.
16403800|NCT01947959|Drug|Rivaroxaban (Xarelto, Bay59-7939)|"The treatment of DVT or PE, and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).
~The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets).
~The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).
~Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid])."
16403801|NCT01947959|Drug|Standard of care|For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.
16403802|NCT01942135|Drug|Palbociclib|Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
16403803|NCT01942135|Drug|Fulvestrant|Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
16403804|NCT01942135|Drug|Placebo|Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
16403805|NCT01942135|Drug|Fulvestrant|Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
16403806|NCT01918514|Drug|Adding Magnesium Sulfate to the standard epidural and interscalene blocks for chronic pain|
16403807|NCT01917929|Device|Secur-Fit Advanced Hip Stem|Straight femoral stem intended for cementless, press-fit application.
16403808|NCT01904994|Procedure|POC (point-of-care) CD4+ (cluster of differentiation 4) Count|Each HIV testing and counseling (HTC) site will be equipped with POC CD4+ testing using PIMA™ Analyser (Inverness), test strips, and reagents. Study staff will obtain 25 microliters of blood via finger prick and process the POC (point-of-care) CD4+ (cluster of differentiation 4) Count' test immediately following the baseline interview. Test results will be recorded on study forms including a referral form that has multiple copies, one copy to be given to the participant, the second sent to the affiliated HIV (Human immunodeficiency virus)care clinic in the study unit, and the third kept by study staff in a locked cabinet with other confidential material. All participants, regardless of the CD4+ result, will be encouraged to enroll in HIV care as soon as they can.
16403809|NCT01904994|Procedure|Accelerated ART (antiretroviral therapy) Initiation|"Accelerated ART initiation for patients with POC CD4+ < 350 cells/uL (micro-liter) within 1 week from testing.
~2 counseling sessions (one at time of HTC and other at first HIV clinic visit), and collection of blood for other baseline lab tests, but initiation prior to return of results for patients who do not meet criteria for waiting"
16403932|NCT05092659|Behavioral|Patient interview|Each patient included will be interviewed between 2 and 6 times in the 3 months following surgery in order to narrate his or her care pathway
16403810|NCT01904994|Behavioral|Basic Care and Prevention Package|Basic care and prevention package (BCPP) provided approximately every three months that includes: condoms; soap, pill box and pictorial education about use of materials and HIV, such as family testing tools and information. Information on BCPP contents and review the educational materials will be provided. An example of educational materials is a family-testing tool to encourage the participant to have all family members tested for HIV. All BCPP items will be replenished every 3 months for all participants, regardless of ART status, beginning at linkage to HIV care.
16403811|NCT01904994|Behavioral|Cellular Appointment Reminders and Follow-Up|"SMS (short messaging service) appointment reminders for follow-up appointments.
~Telephone call within 7 days of missed appointment for all patients."
16403812|NCT01904994|Other|Financial Incentive|Participants will receive a series of financial incentives to support linkage into care within 1 month and retention in care at 6 months and 12 months after testing HIV positive. The value of the financial incentive (FI) will be 80 Swaziland Rand, calculated based on the associated financial costs of traveling to clinic. These incentives will be distributed by through mobile airtime. Participants without mobile phones will be given an alternative incentive of equal value, such as a store voucher.
16403813|NCT01878721|Radiation|PET/CT|positron emission tomography/computed tomography
16403814|NCT01874353|Drug|Olaparib 300mg tablets|300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
16403815|NCT01874353|Drug|Placebo to match olaparib 300mg|300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
16403816|NCT01872260|Drug|LEE011|LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.
16403817|NCT01872260|Drug|Letrozole|Letrozole 2.5 mg/day
16403818|NCT01872260|Drug|BYL719|BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4
16403819|NCT01861106|Procedure|Allogeneic HSCT|Stem cell transplant
16403820|NCT01861106|Drug|Busulfan Test dose|0.8 mg/kg IV infusion over 3 hours one time dose administered 5 to 14 days prior to start of preparative regimen (Days -11 to -20)
16403821|NCT01861106|Drug|Fludarabine (Fludara, Berlex Laboratories)|40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
16403822|NCT01861106|Drug|Busulfan (Busulfex)|3.2 mg/kg IV (in the vein) over 3 hours once daily on Days -6, -5, -4 and -3 (weight based dosing). If in Arm B and if poor or very poor risk clonal chromosomal abnormalities, busulfan will also be given on day -2.
16403823|NCT01861106|Drug|Cyclophosphamide (CTX, Cytoxan)|14.5 mg/kg IV (in the vein) infusion over 30 minutes once daily on days -6 and -5 (weight based dosing) or 50 mg/kg IV infusion over 2 hours on day -6 (weight based dosing). For post-transplant, 50/kg IV once daily x2 doses on days +3 and +4
16403824|NCT01861106|Procedure|Total Body Irradiation (TBI)|200 cGy on Day -1
16403825|NCT01861106|Drug|Mycophenolate mofetil (MMF)|15mg/kg IV over 2 hours BID starting on day +5 will continue until day +35 (+/- 2 days)
16403826|NCT01861106|Drug|Tacrolimus|0.02mg/kg IV continuous infusion over 24 hours starting on day +5 until day +180
16403827|NCT01861106|Biological|Equine Anti-Thymocyte Globulin|(Deleted this intervention per amendment I): 30mg/kg IV (in the vein)once daily x 3 days on Days -6, -5, -4 (3 doses total)
16403829|NCT01839396|Device|Deep Brain Stimulation|The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.
16403830|NCT01823562|Drug|lyophilized black raspberry confection|Given PO
16403831|NCT01823562|Other|laboratory biomarker analysis|Correlative studies
16403832|NCT01823562|Dietary Supplement|dietary intervention|Follow a low polyphenol diet
16403833|NCT01823562|Dietary Supplement|dietary intervention|Follow a low ellagitannin diet
16403834|NCT01823562|Procedure|quality-of-life assessment|Ancillary studies
16403835|NCT01823562|Other|questionnaire administration|Ancillary studies
16403836|NCT01815359|Procedure|Cytoreductive Surgery|Optimal Surgical Debulking
16403837|NCT01815359|Drug|HIPEC with Mitomycin-C|
16403838|NCT01815359|Drug|EPIC with FUDR and Leucovorin|
16403844|NCT01796665|Drug|Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%|
16403845|NCT01796665|Drug|Acanya Gel|
16403846|NCT01796665|Drug|Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product|
16403847|NCT01738815|Drug|Valproic Acid|500 mg orally, once daily for up to 30 days
16403848|NCT01711931|Device|Implantation of everolimus-eluting bioresorbable vascular scaffold stent|
16403849|NCT01711931|Device|Implantation of everolimus-eluting stents|
16403850|NCT01711931|Device|Implantation of biolimus-eluting stents|
16403851|NCT01673659|Drug|Mometasone furoate|
16403852|NCT01673659|Drug|Nasonex Nasal Spray|
16403853|NCT01673659|Drug|Placebo nasal spray|
16403854|NCT01652209|Biological|Hearticellgram-AMI|
16403965|NCT05092360|Biological|Nemvaleukin|Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
16403857|NCT01511237|Drug|Nevirapine, zidovudine, lamivudine|"Mothers: One NVP 200 mg tablet at onset of labor with continuation of HAART for four weeks postpartum
~Newborn: AZT+3TC+ NVP for 2 weeks, followed by AZT+3TC for 2 weeks:
~NVP syrup 2 mg/kg every 24 hours for seven days, followed by NVP syrup 4 mg/kg every 24 hours for seven days. Newborns less than 2500 g will be administered 2mg/kg NVP syrup at each intake
~AZT syrup 4 mg/ kg will be given every 12 hours for four weeks (preterm infants less than 30 weeks will be administered 2 mg/kg every 12 hours; preterm 30-35 weeks will receive 2 mg/kg every 12 hours for the first 2 weeks, increased to 3 mg/kg for the next 2 weeks).
~3TC syrup 2 mg/kg every 12 hours for four weeks."
16403858|NCT01503086|Procedure|Cognitive Assessment|Ancillary studies
16403859|NCT01503086|Other|Computer-Assisted Cognitive Training|Receive computer-assisted cognitive training
16403860|NCT01503086|Procedure|Psychosocial Assessment and Care|Ancillary studies
16403861|NCT01503086|Other|Quality-of-Life Assessment|Ancillary studies
16403862|NCT01503086|Other|Questionnaire Administration|Ancillary studies
16403863|NCT01420237|Device|Restoration ADM X3 Device|Restoration ADM X3 Device in total hip replacement.
16403865|NCT01329224|Other|Measurement of platelet anti-aggregation|Whole blood impedance platelet aggregometry was performed with the Multiplate analyzer (Dynabyte, Munich, Germany) to test the response to ASA with arachidonic acid as the trigger.
16403874|NCT01300832|Procedure|Duplex scan of lower extremities|Lower extremities will be duplex scanned pre and post-operatively
16403877|NCT01226316|Drug|AZD5363|Patients will receive a single dose of AZD5363, administered orally, followed by a 3-7 day wash-out period. Patients will then commence with twice-daily dosing, administered orally, every day, to cessation of therapy.
16403878|NCT01226316|Drug|AZD5363|Patients will be given AZD5363 administered orally as a single dose, followed by a 3-7 day wash-out period. Patients will then receive AZD5363 twice daily on 6 or fewer days per weekly regimen, to cessation of therapy. Parts C,D: Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment, to cessation of therapy.
16403879|NCT01226316|Drug|AZD5363|Optional additional schedule. Patients will be given AZD5363 administered orally. Regimen to be determined in response to emerging clinical findings.
16403880|NCT01226316|Drug|AZD5363|Patients will receive oral AZD5363 twice daily (4 days on 3 days off treatment)combined with background therapy of fulvestrant at licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter.
16403892|NCT01063751|Device|Tritanium® Primary Acetabular Shell|Tritanium® Primary Acetabular Shell in total hip replacement.
16403966|NCT05092360|Drug|Pegylated Liposomal Doxorubicin (PLD)|40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)
16403897|NCT00958789|Device|Triathlon TS Knee System|Total knee replacement for revision cases
16403898|NCT00936858|Drug|RAD001|
16403907|NCT00625378|Drug|Sorafenib (Nexavar, BAY43-9006)|
16403908|NCT00271180|Device|Device|
16403925|NCT05092737|Procedure|Prone positioning|Prone position during invasive mechanical ventilation
16403926|NCT05092724|Procedure|fetal blood transfusion|transfusion of fetal blood
16403927|NCT05092711|Behavioral|Observation|Using INTERASPIRE model to determine patients with established CHD whether the guidelines on cardiovascular disease prevention are being followed or not with incorporation of COVID 19 as a risk factor with the other classical risk factors to understand significance of the new pandemic virus in mortality and morbidity of CVD and coronary events in association with the other known classical risk factors .
16403928|NCT05092711|Drug|Observation|Using INTERASPIRE model to determine patients with established CHD whether the guidelines on cardiovascular disease prevention are being followed or not with incorporation of COVID 19 as a risk factor with the other classical risk factors to understand significance of the new pandemic virus in mortality and morbidity of CVD and coronary events in association with the other known classical risk factors .
16403929|NCT05092698|Dietary Supplement|Vitamin D (cholecalciferol)|Patients will receive either 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil or matched placebo orally or via feeding tube after serum Vitamin D concentrations measurement followed by either the same dose of cholecalciferol or 45 ml of pure herbal oil weekly until discharge or death.
16403930|NCT05092685|Genetic|AAVLK03hOTC|Peripheral intravenous infusion of AAVLK03hOTC.
16403931|NCT05092672|Behavioral|Exercise|Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min
16403933|NCT05092646|Biological|Axolotl Ambient|Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
16403934|NCT05092646|Drug|"Drug/Placebo: 0.9% Normal Saline"|"Drug/Placebo: 0.9% Normal Saline"
16403935|NCT05092633|Device|Miniscrew|Application of laser on miniscrew
16403936|NCT05092607|Diagnostic Test|Venous and Capillary blood sampling|"Venous sample at the bend of the elbow (7mL) taken immediately after the nasopharyngeal sample.
~Capillary blood sampling, for patients included in participating centers"
16403937|NCT05092581|Drug|casirivimab+imdevimab|Single dose weight-based equivalent administered intravenously (IV)
16403938|NCT05092555|Diagnostic Test|Nasopharyngeal swap for RT-PCR|Nasopharyngeal swap and Blood sample is taken for doing previous tests and CT chest is done for all patients
16403939|NCT05092542|Behavioral|Refugee and Immigrant Well-being Project (RIWP)|6-month mental health intervention that pairs university students with newcomers to engage in mutual learning, resource mobilization, and social change efforts
16403940|NCT05092516|Device|Active tDCS|2 mA of anodal stimulation will be applied to the left prefrontal cortex over the F3 electrode based on the International 10-10 EEG system.
16403941|NCT05092516|Device|Sham tDCS|Sham stimulation will be applied to the left prefrontal cortex over the F3 electrode.
16403942|NCT05092503|Drug|JINZHEN Granules for Oral Solution|JINZHEN granules will be dissolved in drinking water and administered orally.
16403943|NCT05092503|Drug|Placebo|Placebo granules will be dissolved in drinking water and administered orally.
16403944|NCT05092490|Procedure|Combined serratus anterior plane block and transversus thoracis plane block|The study group will receive a combined plane block by a dedicated anesthesia team prior to their procedure. 20 mL of local anesthetic (0.25% bupivacaine) will be injected for the Serratus anterior plane block and another 20 mL of local anesthetic (0.25% bupivacaine) will be injected in transversus thoracis plane block
16403945|NCT05092490|Procedure|Standard local infiltration technique|Local anesthetic infiltration of the incision sites will be performed by the cardiologist prior to, and as, necessary during the procedure. The amount of local anesthetic used will be determined intraoperatively by the cardiologist according to the patients' requirements.
16403946|NCT05092477|Behavioral|Integrated Intervention for Breast Cancer Survivors with Diabetes|"All pilot participants will be required to have a SMB target to be included in this study. A SMB target will be chosen by the participant after reviewing their 18mo follow-up responses with the Care Coach. Participants may endorse a maladaptive belief or emotional response; however, this is not required to participate in this intervention. At each follow-up session, the Care Coach will review the participant's SMB goal and progress, address participant's challenges and suggest alternatives, and correct further misinformation on the disease(s). Additionally, the Care Coach will reinforce or introduce techniques that could help overcome barriers to reaching SMB goal and recommend participants to continue improving on the same goal or begin action planning towards a new SMB goal.
~Just SMB concern
~SMB + maladaptive belief + emotional response
~SMB + maladaptive belief
~SMB + emotional response"
16403947|NCT05092477|Behavioral|Attention Control|Participants in the control arm will receive a brochure to discuss healthy lifestyle behaviors to improve DM management. To control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes, participants also receive 3 calls to discuss study progress, thoughts and feelings about study/illness/behaviors, remind them about returning their pill bottles, and about scheduling for their upcoming 24mo follow-up study interview.
16403948|NCT05092464|Device|Natural Lactic Acid-enriched Cream|The subjects were required to topically apply natural lactic acid-enriched cream twice daily in the morning and evening for the treatment duration of 12 weeks.
16403949|NCT05092451|Drug|Cyclophosphamide|Given by IV
16403950|NCT05092451|Drug|CAR.70/IL15-transduced CB-NK cells|Given by IV
16403951|NCT05092451|Drug|Fludarabine phosphate|Given by IV
16403952|NCT05092425|Other|no intervention|no intervention
16403953|NCT05092412|Radiation|Low-dose radiotherapy|The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.
16403954|NCT05092412|Drug|Durvalumab|Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.
16403955|NCT05092412|Drug|Etoposide, and cisplatin/carboplatin|Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide [80 to 100mg/m2] via intravenous infusion and carboplatin [ The area under the curve (AUC) is 5-6] by intravenous infusion or cisplatin [75-80 mg/m2] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.
16403956|NCT05092399|Procedure|Bariatric Surgery|No study interventions
16403957|NCT05092386|Biological|Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine|The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
16403958|NCT05092386|Biological|Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)|The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
16403959|NCT05092386|Biological|Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)|The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.
16403960|NCT05092373|Drug|Cabozantinib|Given By Mouth
16403961|NCT05092373|Drug|Atezolizumab|Given By IV
16403962|NCT05092373|Device|Nab-paclitaxel|Given By IV
16403963|NCT05092360|Biological|Nemvaleukin and Pembrolizumab Combination|Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
16403964|NCT05092360|Biological|Pembrolizumab|Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
16404665|NCT04717414|Drug|ACE-536|Subcutaneous Injection
16403968|NCT05092360|Drug|Topotecan|4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min
16403969|NCT05092360|Drug|Gemcitabine|1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
16403970|NCT05092347|Drug|REGN5459|Administered by intravenous (IV) infusion
16403971|NCT05092347|Drug|REGN5458|Administered by intravenous (IV) infusion
16403972|NCT05092334|Other|proprioceptive exercises|proprioception exercises included (a)Head relocation it involve the practice of relocating head back to natural head posture and to predetermined positions in range first with eyes open using feedback from a laser attached to their head and then with closed all active movement of cervical flexion extension lateral flexion and rotations were used.(b)Gaze stability oculomotor exercises commencing with eyes movement with the head stationary ,progressing to movement of head with visual fixation on a target. (c) Eye head coordination exercises, commenced with rotation of eyes and head to the same side in both right and left directions. Then progressed with both eyes and head move in opposite direction
16403973|NCT05092334|Other|Strengthening exercise|strengthening exercises which are performed with prone and supine position by placing a towel under head, press towel for 5 seconds with 10-12 repetitions ,one set in a week for six weeks for cervical muscles
16403974|NCT05092321|Behavioral|Aquatic Occupational Therapy|Group of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, shaping, behavioral management, therapeutic relationship and individualized goals.
16403975|NCT05092295|Device|Head and Intraocular Trauma Tool|HITT device to scan eyes of participants up to 3 times (~45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.
16403976|NCT05092295|Diagnostic Test|SCAT-5|Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.
16403977|NCT05092282|Device|Head and Intraocular Trauma Tool|HITT device to scan eyes of participants up to 3 times (~45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.
16403978|NCT05092282|Diagnostic Test|SCAT-5|Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.
16403980|NCT05092243|Device|Transcranial direct current stimulation|A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.
16403981|NCT05092217|Drug|Tirelizumab|Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
16403982|NCT05092217|Procedure|salvage surgery|Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
16403983|NCT05092191|Drug|Cannabis oil vs placebo|"Eligibility, Screening and Baseline (T0):
~Candidates will be seen by both research staff and a neurologist. Full written informed consent will be obtained before completing questionnaires and administering physical and medical evaluations. If eligibility is confirmed, a blood sample will be collected followed by participant randomisation .
~Follow-up visits:
~Randomized participants come back after 4 weeks (T1) for the same assessments administered at T0. Only participants who had a decrease in their level of spasticity can continue their participation in the same allocated arm for an additional period of 12 weeks.
~At the end of the additional period of 12 weeks (T2), another visit is scheduled for a last assessments which are the same as T0 and T1.
~Throughout study, courtesy calls will be scheduled and standard care for MS will also be offered to ensure participants 'safety and well-being."
16403984|NCT05092178|Behavioral|calorie restricted diet and exercise|The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement.The exercise intervention consists of aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for≥2 d•wk for six months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d•wk, while, resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d•wk, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d•wk. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video.
16403989|NCT05092139|Device|endovascular treatment|all enrolled patients must receive endovascular treatment
16403990|NCT05092126|Behavioral|Exercise|Calculate oxygen consumption
16403991|NCT05092113|Drug|a compound glutamine capsule/a compound glutamine capsule simulated placebo|A compound glutamine capsule/a compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
16403992|NCT05092100|Behavioral|Visual stimulus similarity|Visual stimulus similarity will be varied in order to test for effects on memory. Learning protocol (the order and frequency with which stimuli are learned) will also be varied.
16403993|NCT05092100|Other|fMRI|fMRI will be used to measure patterns of BOLD activity during learning.
16403994|NCT05092100|Other|Eye tracking|Eye tracking will be used to measure patterns of eye movements when viewing images.
16403995|NCT05092087|Behavioral|nutrition counseling|nutrition counseling
16403996|NCT05092074|Drug|Vosevi 400/100/100 Oral Tablet|Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX, Vosevi) 400/100/100 oral tablet: 1 table per os per day for 12 weeks
16403997|NCT05092061|Other|Moderate-repetition resistance training|Will undertake resistance training with moderate loads, and moderate repetitions 3 times per week for 7 weeks.
16403998|NCT05092061|Other|High-repetition resistance training|Will undertake resistance training with low loads, and high repetitions 3 times per week for 7 weeks.
16403999|NCT05092048|Other|questionnaire|PHQ-9 and GAD-7 questionnaire
16404024|NCT05091814|Radiation|radiotherapy|patients who recieved radiotherapy after surgical removal of the tumor
16404000|NCT05092035|Diagnostic Test|single high-fidelity expiratory CO2 analysis|in addition to regular pulmonary function testing a real-time high-fidelity assessment of expiratory CO2 will be performed
16404001|NCT05092022|Device|Evalyn Self-Sampling Brush|A self-sampling brush to collect cervical cells for screening purposes.
16404002|NCT05092009|Other|Tissue and blood|Tissue and blood will be derived from patient during a standard of care procedure
16404003|NCT05091996|Procedure|Post-isometric muscle relaxation technique|"1: Therapist (T) abducted the patients' (P) mandible until the functional barrier. P performed isometric tension of the mandibular adductors with about 20% of the maximum force, balanced by the T. After 10 secs of isometric tension, P relaxed his muscles, and T abducted the mandible to a new functional barrier. During one treatment, the cycle was repeated 3 times, each time starting from the previously obtained barrier.
~2: T performed passive lateral translation of the mandible until the functional barrier. P performed isometric tension with about 20% of maximum force, as to initiate the movement of the mandible towards the resting position. T balanced the force generated by the P. After 10 secs of isometric tension, P relaxed his muscles and T deepened the lateral movement of the mandible until a new functional barrier was reached. During one treatment, the cycle was repeated 3 times, both to the right and left side, each time starting from the previously obtained barrier."
16404004|NCT05091996|Procedure|Myofascial release technique|The myofascial release procedure was performed successively in the area of: the anterior parts of the temporal muscles , the superficial parts of the masseter muscles and the sternocleidomastoid muscles.During one session, the above cycle was repeated six times on both sides separately. The was lying on his back, with his head turned to the side.The therapist was behind the patient's head, using the pad of the first finger placed on the skin in the area of the initial attachment of a worked muscle, he took out the tissue slack, moving the tissues towards the perceptible limitation of mobility (caudal direction).Reaching the tissue barrier, he kept the tension of the sliding structures, shifting them until the physiological tissue barrier.A single application of the myofascial release procedure consisted of one movement moving the soft tissues along the muscle
16404005|NCT05091983|Other|Sensory Processing Scale Inventory (SPSI)|The Sensory Processing Scale Inventory (SPSI) is the main questionnaire. It allows to define over and under sensitive profiles. It's a self-administrated questionnaire
16404006|NCT05091983|Other|Autism Spectrum Screening Quotient (ASSQ)|"The ASSQ allows to detect autism spectrum disorders (ASD). This quotient is proposed to the group because the investigators know that ASD are often correlated with sensory integration disorders.
~It's answered by the participant's parents."
16404007|NCT05091983|Other|GAD 7|"The GAD7 questionnaire allows to detect anxiety disorder. This questionnaire is proposed to the group because the investigators know that anxiety disorders are often correlated with sensory integration disorders.
~It's a self-administrated questionnaire."
16404008|NCT05091983|Other|Conners abridged|"The Conners abridged questionnaire allows to detect attention-deficit hyperactivity disorder (ADHD). This questionnaire is proposed to the group because the investigators know that ADHD are often correlated with sensory integration disorders.
~The questionnaire is answered by the participant's parents."
16404009|NCT05091983|Other|EAT 26|"The EAT 26 questionnaire allows to detect anorexia nervosa. It is proposed to the patient with an eating disorder to establish the level of severity of their disease.
~It's a self-administrated questionnaire."
16404010|NCT05091970|Procedure|Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)|Three 60-minute sessions per week with a minimum of 6 sessions and a maximum of 10 sessions. This intervention is to be delivered by trained Occupational Therapists (OTs) and Speech-Language Pathologists (SLPs), and includes training in compensatory strategies, direct training of cognitive subskills (e.g., attention training), and assigned homework to practice skills learned in treatment.
16404011|NCT05091957|Other|Community Support Worker|structured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria.
16404012|NCT05091957|Other|Usual Care|Participants in both groups will receive a written summary of available resources
16404014|NCT05091918|Device|Motionsense Wearable|Remote patient monitoring
16404017|NCT05091892|Other|Hydrotherapy programm|Treatment
16404018|NCT05091879|Genetic|Multigene pharmacogenomics test|This multigene pharmacogenomics test will report genetic variation for genes that have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines.
16404019|NCT05091866|Other|Quality-of-Life Assessment|Ancillary studies
16404020|NCT05091866|Other|Questionnaire Administration|Ancillary studies
16404021|NCT05091866|Biological|Therapeutic Progesterone|Given SC
16404025|NCT05091801|Behavioral|Intervention|Participants will have one week of increased chewing time (chew food until they reach an apple sauce consistency)
16404026|NCT05091788|Device|Venus Aime|Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles.
16404027|NCT05091775|Drug|Asacol is used to treat and prevent mild to moderate acute fissure disease|Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.
16404028|NCT05091762|Behavioral|exercise|Upper limb resistance training with blood flow obstruction
16404029|NCT05091749|Biological|blood samples|troponin measurement
16404030|NCT05091736|Diagnostic Test|blood glucose measurement, blood glucose monitor for personal use|measurement of the blood glucose concentration using the blood glucose monitor for personal use (BG-709b)
16404031|NCT05091736|Diagnostic Test|blood glucose measurement, laboratory reference device|measurement of the blood glucose concentration using a laboratory reference device
16404032|NCT05091723|Drug|Nezulcitinib (TD-0903) Dose A|TD-0903 Dose A
16404033|NCT05091723|Drug|Nezulcitinib (TD-0903) Dose B|TD-0903 Dose B
16404034|NCT05091710|Other|HF follow up care|The intervention will consist of follow up phone calls and visits during which the CHWs will remind patients about upcoming visits, ensure patient has sufficient medications, review medication schedule and provide education as needed.
16404035|NCT05091710|Other|HF Standard of Care (SOC)|SOC after discharge for HF is to notify patients of a follow-up visit at the hospital/clinic - about 7 days after discharge and provide patients about 30 days of medications at discharge. If a patient does not return for a follow-up appointment, there are no systems to track this missed visit, or to trigger active attempts to contact patients. For patients who come back to their scheduled 7-day visit, there is generally a 14-day visit followed by a 28-day visit.
16404036|NCT05091697|Behavioral|Multicomponent treatment VIRTUAL FIBROWALK + TAU|To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)
16404037|NCT05091684|Drug|Fibrinogen concentrate - Clottafact®|Refractory transfused patients who present grade ≥ 2 hemorrhagic symptoms will receive a single injection of Clottafact® (1.5g) followed by platelet transfusion within 2 hours. Blood sampling will be done at different time points to measure clot viscoelasticity: at baseline, after fibrinogen injection, after platelet transfusion and the day after transfusion or before the next platelet transfusion if < 24 hours.
16404038|NCT05091671|Other|Free From Pain Exercise Programme Variation 1|Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets.
16404039|NCT05091671|Other|Free From Pain Exercise Programme Variation 2|Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets, and the 12 Zoom online sessions.
16404040|NCT05091658|Device|LH Urine Test|Test for qualitative detection of LH in urine
16404042|NCT05091632|Procedure|Electroencephalography|Undergo EEG
16404043|NCT05091632|Other|Questionnaire Administration|Complete questionnaires
16404047|NCT05091606|Procedure|Perfusion İndex in Patients with Spinal Anesthesia|Comparison of lower and upper extremity perfusion index values
16404048|NCT05091593|Behavioral|Stepped collaborative care intervention|Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional.
16404049|NCT05091593|Behavioral|Enhanced Usual Care|Usual care from health providers
16404050|NCT05091580|Behavioral|Interpersonal Counseling|Interpersonal Counseling is a brief (four sessions) psychological intervention that was developed to treat depression in primary care. In IPC, counselors provide psychoeducation about the connection of depressive symptoms to social triggers and support patients in leveraging social networks to address these stressors and reduce depressive symptoms. Since depressive symptoms are often a transient reaction to life stress (e.g. TB diagnosis), many individuals are able to achieve significant alleviation of symptoms in as few as four sessions. IPC focuses on reducing interpersonal conflict and improving social cohesion in families, which may have the advantage of strengthening the ability of families to support TB patients in completing treatment to achieve cure.
16404051|NCT05091580|Behavioral|Enhanced treatment as usual|Depression screening and referral (as needed)
16404052|NCT05091567|Drug|Atezolizumab|Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
16404053|NCT05091567|Drug|Lurbinectedin|Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
16404054|NCT05091567|Drug|Carboplatin|Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
16404055|NCT05091567|Drug|Etoposide|Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
16404056|NCT05091554|Procedure|intraoral ice pack application|Tap water was filled into plastic ice molds and kept in the freezer in the clinic until the application was made. The ice packs used were weighed with digital pocket scale (Knmaster CT1000, Turkey) as 6-8 grams. In the cryotherapy groups, at the end of the first appointment ice packs were removed from the freezer, wrapped in sterile gauze and placed on the vestibular mucosa of the teeth.
16404118|NCT05090982|Other|Audio recordings during the consultations and test of the shared medical decision-making tool for validation|50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.
16404057|NCT05091541|Drug|Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection|CT120 is an autologous CD19/22 targeted CAR-T cells injection. The dosage form is a cryopreserved injection solution. The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma.
16404058|NCT05091528|Drug|SBT6050|Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
16404059|NCT05091528|Drug|trastuzumab deruxtecan|5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
16404060|NCT05091528|Drug|tucatinib|300 mg by mouth (PO) twice daily (BID)
16404061|NCT05091528|Drug|trastuzumab|8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
16404062|NCT05091528|Drug|capecitabine|1000 mg/m2 PO BID for 14 days of each 21-day cycle
16404063|NCT05091528|Drug|trastuzumab deruxtecan|6.4 mg/kg by IV infusion in 21-day cycles
16404064|NCT05091515|Other|Personal protective equipment from biological hazard|Includes: isolation clothing, mask, eyewear, overshoes
16404065|NCT05091502|Diagnostic Test|Personalised musculoskeletal modeling|Magnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models
16404066|NCT05091489|Other|Qualitative assessment about PrEP acceptability|Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
16404067|NCT05091476|Device|OPTiC System|OPTiC System procedure
16404068|NCT05091463|Device|Biostim-5/Neostim transcutaneous spinal stimulator|Transcutaneous spinal stimulation (scTS): The 5-channel stimulator capable of generating pain-free biphasic rectangular waveform of 0.3 to 1.0 ms pulses with a frequency of 5-10 kHz will be used to stimulate at single or multi-site spinal levels. Transcutaneous stimulation will be delivered in combination with activity based locomotor training in 5-10 minute bouts of stimulation at sub-motor threshold during daily sessions (5x/week) lasting for 90 minutes for a total of 60 sessions of therapy. The sessions will consist of 55-60 minutes on the treadmill for facilitated standing/stepping followed by 30 minutes of activities off the treadmill in sitting, standing, or stepping.
16404069|NCT05091450|Behavioral|Couple-based I-BMS intervention for infertility|It is based on the previous I-BMS intervention for women undergoing IVF treatment, and aims to improve fertility quality of life and couple flourishing by (1) increasing awareness of the interconnectedness between physical and psychosocial well-being, (2) practicing body-mind-spirit techniques, (3) facilitating personal growth and partner empathy and compassion, and (3) creating the shared meaning of life, family, children. As a strength-focused and meaning-oriented approach, it utilizes experiential and self-reflective exercises to help participants reconstruct the meaning behind their ordeal and rediscover the strengths that keep them going.
16404070|NCT05091437|Diagnostic Test|Observational study|Incidental lung nodules identification
16404071|NCT05091424|Drug|Mosunetuzumab|Participants will receive subcutaneous (SC) mosunetuzumab for up to 17 cycles (cycle = 21 days).
16404072|NCT05091424|Drug|Tocilizumab|Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
16404073|NCT05091411|Biological|Recombinant new coronavirus vaccine (CHO cell) group|Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
16404074|NCT05091398|Other|Regional analgesia of thoracic surgical patients|ultrasound-guided erector spinae block on T4 and T6 levels ,paravertebral block or intercostal nerve block after the anesthesia induction and turning the patient in the lateral position with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .
16404075|NCT05091385|Biological|Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019|Mepolizumab administered within the frame of a severe asthma treatment program financed by National Health Fund in Poland for patients fulfilling specific criteria of asthma severity.
16404076|NCT05091372|Drug|Belantamab mafodotin|Given by PO
16404077|NCT05091372|Drug|Lenalidomide|Given by PO
16404078|NCT05091359|Device|Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste|Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant
16404081|NCT05091320|Drug|Mechanical thrombectomy|Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke
16404082|NCT05091320|Drug|medical treatment|medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet
16404087|NCT05091281|Device|Intubation of the double lumen tube by Macintoch laryngoscope|After induction of anesthesia insertion of the double lumen tube was done by Macintosh laryngoscope
16404088|NCT05091281|Device|Intubation of the double lumen tube by Glidescope videolaryngoscope|After induction of anesthesia insertion of the double lumen tube was done by GlideScope® videolaryngoscope
16404089|NCT05091281|Device|Intubation of the double lumen tube by C-MAC®(D) videolaryngoscope|After induction of anesthesia insertion of the double lumen tube was done by C-MAC®(D) videolaryngoscope
16404090|NCT05091268|Behavioral|Exercise|"All participants will attend a four-hour pain education session including gynecologist, psychologist, sexologist, and physiotherapist at Akershus University Hospital.
~The education will be held twice, with half of the participants at the time. The training group will then attend a 60 minutes weekly group training session led by a physiotherapist with specialist training in women's health over a period of four months. In addition, participants will perform a progressive home exercise program performed daily over the same period. The focus will be general strength training using own body weight and cardiovascular fitness (walking, low-impact aerobic exercise), stretching, and relaxation"
16404119|NCT05090956|Other|mri|
16404666|NCT04717414|Other|Placebo|Subcutaneous Injection
16404091|NCT05091255|Procedure|Cryotherapy|The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.
16404094|NCT05091216|Other|Traditional Chinese Medicine mouthwash|The mouthwash used in this test is based on the records of past traditional Chinese medicine classics and the existing antibacterial experimental evidence. The selected medicinal materials are honeysuckle, scutellaria, peppermint, licorice, and rhizome.
16404095|NCT05091216|Other|Dilute 50 times of Traditional Chinese Medicine mouthwash|Dilute 50 times of traditional Chinese medicine mouthwash.
16404096|NCT05091203|Drug|Vitamin D|To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure
16404097|NCT05091190|Other|Blood draws|"Blood draws will be realized at the following time points:
~C1T1: at the baseline, before treatment administration. C1T2: cycle 1, after treatment administration. C2T1: the day of the 2nd cycle, before treatment administration. C2T2: the day of 2nd cycle, after treatment administration. C3T1: the day of the 3rd cycle, before treatment administration. C3T2: the day of 3rd cycle, after treatment administration."
16404098|NCT05091177|Diagnostic Test|Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation|Use relevant instruments for inspection
16404099|NCT05091164|Procedure|Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis|Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.
16404100|NCT05091151|Drug|Intranasal dexmedetomidine at dose of 2 mcg/kg and 4 mcg/kg|Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.
16404101|NCT05091138|Drug|Adding Magnesium as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty|Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate in the block and the other half will receive 300 mcg of buprenorphine in the block.
16404102|NCT05091138|Drug|Adding Buprenorphine as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty|Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate in the block and the other half will receive 300 mcg of buprenorphine in the block.
16404103|NCT05091125|Diagnostic Test|Diagnostic performance of the S100B protein dosage|Dosage of the S100B protein in patients with mild head trauma with complication risks
16404104|NCT05091112|Procedure|Spinal surgery|In participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis.
16404105|NCT05091112|Other|Histology|The harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out
16404106|NCT05091099|Drug|Alendronate|On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time Alendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).
16404107|NCT05091086|Drug|Denosumab|Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
16404109|NCT05091060|Device|Erchonia HLS|56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.
16404110|NCT05091047|Device|Erchonia EVRL|42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
16404111|NCT05091034|Behavioral|Controlling Asthma Program for Adolescents (CAMP Air)|Controlling Asthma Program for Adolescents (CAMP Air) is an e-health intervention grounded in social cognitive theory and motivational interviewing to guide teens through asthma self-care and how to navigate the health care system. It makes use of various interactive and personalized approaches.
16404112|NCT05091034|Behavioral|Attention Control Asthma Education Intervention|Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.
16404113|NCT05091008|Drug|Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet|proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)
16404114|NCT05090995|Behavioral|Behavioral Self-Management and Feedback|Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.
16404115|NCT05090995|Behavioral|Behavioral Self-Management|Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.
16404116|NCT05090982|Other|Audio recordings during the consultations|50 patients with audio recordings of the consultation
16404117|NCT05090982|Other|Audio recordings during the consultations and test of the shared medical decision-making tool for modification|50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification
16404217|NCT05071196|Other|Facilitated Vegan Diet|Vegan boxed meal kits
16404120|NCT05090943|Other|QOL to be completed by the participant|The scales (PUTS, OCI, TS-QOL, ASRS, GAD-7, PHQ9, TAPS) to be completed by the participant
16404121|NCT05090930|Device|HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection|HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, which is based on the removal of cytokines from whole blood by sorption on a special hemoadsorbent due to the peculiarities of its porous structure and inner surface, which is indicated in conditions where cytokine levels are extremely elevated
16404122|NCT05090930|Device|CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber|CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber is a biocompatible polymer with high adsorption capacity, which is indicated in conditions where cytokine levels are extremely elevated
16404123|NCT05090904|Drug|Brensocatib|Oral tablet
16404124|NCT05090904|Drug|Placebo|Oral tablet
16404125|NCT05090891|Drug|INCB000928|INCBG000928 will be administered QD orally.
16404126|NCT05090891|Drug|placebo|placebo will be administered QD orally
16404129|NCT05090852|Device|Hi-VNI|Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery
16404130|NCT05090839|Behavioral|Weekly Emotional Disclosure (WED)|Online writing session with each session lasting approximately 30 minutes. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
16404131|NCT05090826|Device|Model ZFR00V|Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.
16404132|NCT05090813|Device|Model ICB00|Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.
16404133|NCT05090800|Drug|Definity contrast during ultrasound|Participants will undergo an ultrasound contrast evaluation of both kidneys. This will include placement of an intravenous (IV) catheter in a vein and the delivery of Definity ultrasound contrast agent through the IV. Imaging will be completed for each kidney. The proposed total dose for adult patients will not exceed 20 microliters/kilograms (kg). Each individual dose not to exceed 10 microliters/kg. At initiation of patient studies, the dose will start at 10 microliters/kg for the first injection and a second 10 microliters/kg dose to evaluate the contralateral kidney. However, if ultrasound findings in patient studies demonstrate a dose that is too high (unable to make accurate ultrasound assessment), the dose will be reduced.
16404134|NCT05090787|Device|Investigational mDCB00|Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
16404135|NCT05090787|Device|Control DCB00|Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes
16404136|NCT05090774|Behavioral|Adapted Otago Exercise Program (OEP)|A modified version of the 8- week evidence-based Otago Exercise Program (OEP), adapted for integration into supervised exercise therapy (SET). The OEP exercises will include 12 static and dynamic standing balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking). The OEP also contains additional behavior change techniques embedded within the intervention protocol (i.e. feedback on behavior, self-monitoring of behavior, biofeedback).
16404137|NCT05090761|Drug|Bupivacaine 0.25% Injectable Solution|Injection of Bupivacaine 0.25% Injectable Solution for SAPB
16404138|NCT05090761|Drug|Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg|Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate as adjuvant
16404139|NCT05090761|Drug|Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 150 mg, Buprenorphine 300 mcg|Injection of Bupivacaine 0.25% Injectable Solution for SAPB Addition of 150 mg of Magnesium Sulfate and 300mcg Buprenorphine as adjuvants
16404140|NCT05090748|Device|Echocardiographic.|Echocardiographic test.
16404141|NCT05090735|Procedure|SPIP and TAP Block|Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.
16404142|NCT05090735|Procedure|SPIP Block|Injection of Bupivacaine 0.25% for SPIP Block
16404143|NCT05090722|Device|PureWick System|The PureWick system consists of the external catheter, collection tubing, and collection canister with lid. It operates via a power cord that is plugged into the device outlet and the A/C power outlet.
16404144|NCT05090709|Other|Spinal Mobilisation Intervention|30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.
16404145|NCT05090709|Other|General Massage|30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.
16404146|NCT05090696|Device|Mechanical In-Exsufflator (MI-E)|The feasibility will be estimated by quantifying relief and discomfort of four MI-E sessions (2 days x 2 sessions = 4 sessions). Vital signs will be also noted before and after such MI-E session.
16404147|NCT05090683|Behavioral|Mind-body mobile application|Self-directed; Study team will recommend daily use of mobile app for 6 weeks with a minimum of 4 times/week usage of mobile app for 6 weeks. Frequency will be monitored via weekly surveys.
16404148|NCT05090670|Other|Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy|Germanium-Embedded Knee Brace will be applied to the effected limb following Knee Arthroscopy
16404149|NCT05090670|Other|Replica Knee Brace|Replica Knee brace will be applied to the effected limb following Knee Arthroscopy
16404218|NCT05071196|Other|Omnivorous Diet|Non-vegan boxed meal kits
16404219|NCT05069896|Drug|Mirikizumab Prefilled Syringe|Administered SC by prefilled syringe
16404220|NCT05069896|Drug|Mirikizumab Autoinjector|Administered SC by autoinjector
16404150|NCT05090657|Combination Product|methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation|After topical application photosensitive solution bilateral nasal light diffusers will be inserted into each nostril and two 2-minute non-thermal light applications of 670 nm light will be used to activate the photosensitizer to achieve an oxidative burst to destroy pathogens.
16404151|NCT05090644|Genetic|DNA analysis|GWAS
16404152|NCT05090631|Genetic|DNA analysis|GWAS
16404153|NCT05090618|Genetic|DNA analysis|GWAS
16404154|NCT05090605|Genetic|DNA analysis|GWAS
16404155|NCT05090592|Device|orthokeratology|orthokeratology wearing for myopia control
16404156|NCT05090592|Drug|0.01 atropine|0.01% atropine eye drop prevent myopic progression
16404157|NCT05090579|Procedure|Group I (BN10)|patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 1 mL of 10 mg of nalbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
16404158|NCT05090579|Procedure|Active Comparator:Group ll (BN20)|patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 2 mL of 20 mg of nalbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
16404159|NCT05090579|Procedure|Active Comparator:Group lll (B)|patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
16404160|NCT05090566|Drug|Elranatamab + Nirogacestat|BCMA-CD3 bispecific antibody + gamma secretase inhibitor
16404161|NCT05089656|Genetic|OAV101|Gene therapy
16404162|NCT05089656|Procedure|Sham control|The sham procedure will consist of a small needle prick on the lower back at the location where the LP injection is normally made. The needle will break the skin, but no needle insertion for lumbar puncture will occur.
16404163|NCT05087537|Procedure|Valve ablation|Valve ablation
16404164|NCT05087537|Procedure|Valve ablation and bladder neck incision|Valve ablation and bladder neck incision
16404165|NCT05085041|Behavioral|Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)|The investigators will provide 8 sessions of a multi-component education intervention to the participants in the intervention group. Each session will address parental nutrition knowledge, self-efficacy, and attitudes around feeding, parental modeling of healthy foods, and skill development to increase success in making behavioral changes. The intervention curriculum will be informed by Social Cognitive Theory to help parents guide young children to engage in healthy eating behaviors through modeling (Curriculum Design). The investigators will deliver the intervention using multicomponent to enhance and maximize the learning experiences of the participants for successful behavior changes. The intervention will be comprised of instructional videos, text messages with key information, online cooking activities, and telephone consultation (Modality).
16404166|NCT05083143|Behavioral|COVID-19 pandemic|Patients diagnosed with testicular cancer in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared.
16404167|NCT05082857|Behavioral|"traditional Parents as Teachers (PAT)"|A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others.
16404168|NCT05082857|Behavioral|"hybrid PAT model"|A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking.
16404169|NCT05082636|Other|Observational Study ( Tissue Biopsy )|control study includes a total of 90 subjects. Of them 54 patients with early stage lung (stage I, II) cancer (Group 1) were selected from the Chest Department of Assiut University Hospital, besides 36 healthy controls; who were clinically suspicious with chest masses and proven histopathologically to be negative cancer (Group 2).obtained by fiberoptic bronchoscopy
16404170|NCT05082597|Device|Low energy ESWT|Therapeutic sessions: 4(once a week, for 4 weeks) Total dosage: 2500 shoots over axillary cord lesion (1000 over most fibrotic area, 500 over upper arm, 500 over forearm, 500 over other area) Energy: 0.056-0.065mJ/mm2
16404171|NCT05082181|Behavioral|UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)|UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home practice assignment. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.
16404172|NCT05082181|Behavioral|BOOST (Bringing Out Our Strength Together)|BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.
16404173|NCT05081583|Drug|Midazolam Hcl 1Mg/Ml Inj|0.5 mL of an intravenous solution (1 mg/mL) will be administered.
16404174|NCT05081583|Dietary Supplement|Goldenseal (Hydrastis canadensis)|Goldenseal (Solaray; Lot #1020199) is supplied as dried root powder in vegetable capsules, each containing 550 mg of herbal content. Goldenseal capsules will be administered with 240 mL of water.
16404175|NCT05081336|Drug|Statin|Statin +/- ezetimib +/- Alirocumab
16404176|NCT05081063|Diagnostic Test|Routine labs|Routine labs will be performed with CBC, BMP, Fox screen, ROTEM viscoelastic test, PT/INR, PTT and venous lactate for standard of care for all patients.
16404177|NCT05080946|Drug|Aspirin 325mg|"Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 cycles. Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery."
16404178|NCT05080946|Drug|Placebo|"Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 cycles. Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery."
16404179|NCT05080751|Behavioral|Eating Behaviors|Materials to be weekly available for intervention group, following a schedule of sessions (six in total): videos, audios, booklets, films, books and other presentations. The intervention will be based online, in a asynchronous modality. Members will self-manage activities.
16404180|NCT05080647|Behavioral|Mightier online gameplay|"Mightier is a video-game-based biofeedback intervention that capitalizes on children's love of video games to increase emotional awareness and facilitate emotion regulation practice through heart rate (HR) control. Each family receives a Mightier Kit (Mighty Band heart rate monitor, dedicated Mightier tablet unless the family prefers to use their own device) and the Mightier App. Children wear a Mighty Band heart rate monitor on their arm while they play any one of 26+ games. As their heart rate rises the games become more difficult. For example, during a cooking game, smoke may appear on the screen and obscure the player's view. Children can either opt into an explicit cool down activity (deep breathing, progressive muscle relaxation, crossing the midline, or visualization) or cool down on their own. By simply playing Mightier, children are motivated to practice calming strategies in moments of challenge."
16404181|NCT05079581|Other|Pelvic floor exercises|"The participants in the intervention group will be taught exercises involving strengthening the muscles around the pelvic floor in sitting, standing and lying positions by a physiotherapist who has been trained in women's health for 4 years and will be asked to perform them as home exercises every day for 8 weeks. The exercises are as follows:
~They will be asked to tighten the muscles around the urethra, vagina and rectum as hard as possible, upwards and inwards (from the bottom up) and hold it in this way for 8-10 seconds. It will be applied in different positions as in the table."
16404182|NCT05079217|Biological|High-dosage SARS-CoV-2 vaccine|SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
16404183|NCT05079217|Biological|Medium-dosage SARS-CoV-2 vaccine|SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
16404184|NCT05078983|Diagnostic Test|CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)|GERIATRIC ASSESMENT TEST
16404187|NCT05078411|Behavioral|Test treatment|"Test treatment will consist of a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on periodontal risk level (as calculated with the PerioRisk tool proposed by Trombelli et al. 2009) and profile (i.e., the magnitude of the contribution of each PerioRisk parameter to generate the patient risk level); (iii) information on treatment plan and oral hygiene instructions, with emphasis to treatment goals based on the PerioRisk output.
~The operators will be trained to administer test treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request."
16404188|NCT05078411|Behavioral|Control treatment|"Control treatment will consist in a single session structured as follows: (i) information on periodontal diagnosis (as formulated according to the classification system of the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions); (ii) information on treatment plan and oral hygiene instructions, and treatment goals. Although the general concept of risk of periodontitis incidence/progression will be explained, no mention will be made to the patient risk level as calculated with PerioRisk or any other tool.
~The operators will be trained to administer control treatment in approximately 8 minutes, but the duration of the session will be extended for additional questions and answers upon patient request."
16404189|NCT05078125|Device|Holter monitoring|24 hours Holter monitoring
16404190|NCT05077865|Drug|MYMD-1|150 mg capsule
16404191|NCT05077865|Drug|Placebo|Matching in appearance to MyMD-1 150mg capsule
16404192|NCT05077839|Drug|Trifluridine/Tipiracil|Trifluridine/tipiracil was approved in the third-line treatment of advanced colorectal cancer. Its efficacy in the first-line treatment was unknown.
16404193|NCT05077683|Drug|Rivaroxaban 2.5 MG [Xarelto]|Experimental group: usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + rivaroxaban 2.5mg twice daily.
16404194|NCT05077683|Drug|DAPT strategy|usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) +
16404195|NCT05077384|Drug|Surufatinib|Surufatinib 300 mg oral once daily
16404196|NCT05077085|Drug|Bezlotoxumab|single intravenous infusion of bezlotoxumab 10 mg/kg
16404197|NCT05077085|Procedure|Fecal Microbiota Transplantation (FMT)|single infusion of 198 cc fecal suspension (derived from 60g donor feces) via duodenal tube or coloscopy
16404198|NCT05077085|Drug|Vancomycin oral|14 days vancomycin oral 125mg QID (250mg QID when 125mg not available)
16404221|NCT05069129|Biological|Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)|Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm
16404222|NCT05069129|Biological|Inactivated COVID-19 vaccine (Vero cells)|Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
16404264|NCT05044117|Drug|Capecitabine|Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year
16404199|NCT05076448|Procedure|Gonadal veins resection|"Gonadal veins resection (GVR) was performed open, transperitoneal and retroperitoneal endoscopic methods under general anesthesia.
~Open GVR was performed in the Trendelenburg position, on the back with the operating table rotating 30° The retroperitoneal approach was employed in the left and/or right iliac region. The GV was mobilized for 10-12 cm and the vein was resected..
~Transperitoneal GVR was performed with 3 ports were placed: one 10-mm port in the umbilical region, one 5-mm port in the left or right iliac region, and one 5-mm port 5 cm below the umbilicus. The GV was mobilized over a length of 10-12 cm and the vessel was resected.
~Retroperitoneal GVR was performed with the patient in a lateral position and in the reverse Trendelenburg position. A 10-mm camera port was installed in the lumbar region between the posterior superior iliac spine and the lower edge of the XII rib. The GV was mobilized over a length of 10-12 cm and the vessel was resected."
16404200|NCT05076448|Procedure|Gonadal vein embolization with coils|"Procedure was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The vein puncture was performed under ultrasound guidance. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035 guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035 standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035 coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm."
16404201|NCT05076448|Procedure|Endovascular stenting of the common iliac vein (CIV)|"After providing local anesthesia, the left common femoral vein was punctured, a 0.035 guidewire was inserted into the inferior vena cava (IVC), and then a 10F introducer was installed. A balloon catheter was introduced over the guidewire in the left CIV (XXL balloon, Boston Scientific, diameter 14-18, length 40-60 mm), and double balloon dilation of the vessel was performed with a pressure of 6-8 atm. Then, a delivery system was advanced to the area of stenosis in the left CIV, and stent was deployed at the level of confluence of the left CIV and inferior vena cava (IVC) or with a protrusion in the IVC of no more than 1 cm. For better fixation of stent in the venous lumen and prevention of its displacements and migration, a balloon post-dilatation of the stented vessel was performed. In case of residual stenosis, the balloon angioplasty was performed."
16404202|NCT05076084|Procedure|QUICK questionnaire and 6 additional questions|QUICK questionnaire and 6 additional questions
16404203|NCT05076084|Other|Retrospective collection of clinical data from the patients' medical records|Retrospective collection of clinical data from the patients' medical records
16404204|NCT05075603|Drug|Tisagenlecleucel|NT-I7 is administered via intramuscular injection 21 days after Kymriah® infusion
16404205|NCT05074953|Other|Exposed to a SARS-CoV-2 infection|The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.
16404206|NCT05074173|Behavioral|Text|These blood pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone application to allow the participant and healthcare team track their blood pressure.
16404207|NCT05074056|Drug|Ketorolac|We will administer intraoperative ketorlac.
16404208|NCT05073497|Other|Finger puppets|In the experimental group, for distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing before and during venipuncture.
16404209|NCT05072210|Other|Mobile Intervention|Active mobile data will be used to provide automated, personalized notifications to frontline healthcare workers. Key information on mental health and links to access additional health resources will be available on the mobile platform.
16404210|NCT05072158|Other|None, this is an observational study|This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.
16404211|NCT05072132|Other|Personal information on genetic susceptibility to arsenic toxicity|The intervention groups will receive information regarding their genetic results that informs them of their arsenic metabolism efficiency. They will receive this information through a factsheet appropriate for a lay audience. The factsheet will contain information regarding arsenic metabolism and its role in removing arsenic from the body. The factsheet will describe how there is variability among individuals with respect to the efficiency with which arsenic is removed from the body, due to inherited differences in genes that affect arsenic metabolism. The factsheet describe how slower metabolizers remove arsenic slower from the body, which leads to increased in toxicity risk. The factsheet will inform participants in the intervention groups that they have been identified as a slow/fast metabolizer of arsenic based on their genes. This information will be given to participants by the URB staff, with a study physician available to address questions and concerns from the participant.
16404212|NCT05072132|Other|standard information on arsenic exposure reduction|In this study, intervention and control groups will receive a standard informational intervention which will remind them of the effects of arsenic exposure and potential strategies that can be implemented to reduce their exposure.
16404213|NCT05072093|Behavioral|PrEP discontinuation intervention|Men taking daily oral PrEP (Truvada) will receive a monthly screener through the mobile app. If answers to screener questions indicate a participant is at risk for PrEP discontinuation, then a peer navigator will deliver a motivational interviewing intervention and a clinician will consult with the participant. These efforts are intended to avert PrEP discontinuation.
16404214|NCT05072093|Drug|Offering of on-demand PrEP|For men who are not interested in daily PrEP or plan to discontinue daily PrEP, the investigators will offer on-demand PrEP (Truvada) which will allow them to take it immediately before/after a sexual encounter. It is hoped that this will serve as an alternative to daily PrEP use that is desirable for some people.
16404215|NCT05072093|Drug|Offering of STI PEP|All men in the cohort will be offered STI PEP (doxycycline) to use after condomless sex with the goal of averting STI diagnoses. At a dosage of 200 mg to be taken in a single dose ideally within 24 hours of possible exposure (e.g. condomless anal sex) and no later than 72 hours after exposure. Participants will be dispensed enough pills to allow for up to 3 weekly doses of 200mg doxycycline (i.e. 6 pills/week) for 3 months (the interval between STI testing visits).
16404216|NCT05071729|Drug|Elinzanetant (BAY3427080)|Single oral dose of elinzanetant on Day 1.
16404223|NCT05069129|Biological|3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)|Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm on 0，30，60 days
16404224|NCT05068921|Drug|TQB2858 injection|TQB2858 is an anti-programmed death ligand 1（PD-L1）/transforming growth factor-β （TGF-β） bi-functional fusion protein.
16404225|NCT05068297|Other|Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction|Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
16404226|NCT05068297|Other|Replica Knee Brace|Replica Knee brace will be applied to the effected limb following ACL reconstruction
16404227|NCT05067985|Procedure|covid 19 spinal anesthesia|this group description covers that all the covid 19 pregnant women which we gave spinal anesthesia for cesarean section procedures. The investigators analyzed them retrospectively.
16404228|NCT05065892|Biological|COVAX|2 doses of Covid-19 vaccine
16404229|NCT05065879|Biological|COVAX|2 doses of Covid-19 vaccine
16404230|NCT05065710|Drug|ZL-1211|Phase 1 dose escalation part will enroll about 12-42 patients, Phase 2 dose expansion part will enroll about 15-40 patients in each cohort
16404231|NCT05065073|Drug|Iodixanol|Iso-osmolar Contrast Media
16404232|NCT05065073|Drug|Iohexol|Low-Osmolar Contrast Media
16404233|NCT05064722|Device|Self Forming Magnets (SFM)|To create the duodenal-ileal diversion, the duodenal magnet will be placed transorally in the proximal duodenum and the distal magnet will be placed in the ileum. Magnets are coupled and a compression induced anastomosis is created.
16404234|NCT05064449|Drug|Soticlestat|Soticlestat tablets.
16404235|NCT05064449|Drug|Itraconazole|Itraconazole oral solution.
16404236|NCT05064449|Drug|Mefenamic acid|Mefenamic acid capsule.
16404238|NCT05062044|Dietary Supplement|Multivitamins (Elevit, BAY987808)|Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol.
16404239|NCT05062044|Dietary Supplement|Multivitamins (Elevit, BAY2906300)|Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol.
16404240|NCT05062044|Drug|Multivitamins (Elevit, BAY987386)|Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol.
16404241|NCT05062044|Dietary Supplement|Folic acid|Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol.
16404242|NCT05059379|Radiation|Entire supraclavicular lymph node radiotherapy|Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.
16404243|NCT05059379|Radiation|Medial supraclavicular lymph node radiotherapy|Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.
16404244|NCT05058651|Biological|Atezolizumab|Given IV
16404245|NCT05058651|Drug|Carboplatin|Given IV
16404246|NCT05058651|Drug|Cisplatin|Given IV
16404247|NCT05058651|Drug|Etoposide|Given IV
16404248|NCT05058651|Other|Patient Observation|Undergo observation
16404249|NCT05056259|Device|18F-FDG PET/CT|"The PET/CT procedure will be performed according to the institutional standard with 18F-FDG (0.8-1.2 mCi /kg) injection following 6 h fasting. Blood glucose was controlled to be <150 mg/dl. PET/CT from the vertex to the middle femur will be obtained 60 min after FDG injection.
~MDCT examination without IV contrast will be done for attenuation correction and anatomic localization followed by PET images from the skull vault to the mid-thigh region.
~Images of CT and corresponding functional PET images are displayed in axial, coronal and sagittal planes.
~PET/CT data will include tumor size and extension, LN invasion& distant metastasis SUVmax will be calculated for all positive lesions, Metabolic parameters including SUVmax, SUVmean, TLG & MTV will be calculated for primary tumor.
~Data of PET will be compared with other diagnostic imaging and postoperative pathologic data."
16404250|NCT05052710|Drug|AZD4831|Subjects will receive oral doses once daily from Days 2-11.
16404251|NCT05052710|Drug|Midazolam|Subjects will receive oral single doses on Day 1 and Day 11.
16404252|NCT05051930|Drug|TQC3721 suspension for inhalation|Participants will receive 0.2 mg/1.0 mg/3.0 mg/6.0 mg/12.0 mg/24.0 mg single dose of TQC3721 suspension for inhalation.
16404253|NCT05051930|Drug|TQC3721 suspension placebo for inhalation|Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation .
16404256|NCT05049343|Drug|SAGE-904|SAGE-904 oral solution.
16404257|NCT05049343|Drug|Placebo|Placebo oral solution.
16404258|NCT05049343|Drug|Ketamine|Ketamine intravenous (IV) infusion.
16404259|NCT05045378|Drug|Midazolam (active placebo)|Arm1: Two 0.045mg/kg midazolam infusions at Day1 and Day3。
16404260|NCT05045378|Drug|Ketamine and Midazolam (active placebo)|Arm2: First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion。
16404261|NCT05045378|Drug|Ketamine|Arm3: Two 0.5mg/kg ketamine infusions。
16404267|NCT05039541|Device|Alio Medical Remote Monitoring System (RMS)|The Alio Medical RMS utilizes a wearable, non-invasive patch (SmartPatch) placed on the AV access of enrolled participants. The SmartPatch gathers physiologic data using optical, mechanical, electrical, acoustic and thermal sensors to collect physiologic data from the participant's vessel related to vascular access health (e.g. volumetric flow and stenosis) and hemodynamic parameters (e.g. Hb/Hct, K+) and transmits it to a bedside hub located in the clinic or participant's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed utilizing Alio's proprietary algorithms. Data is then accessible to the clinical site and Alio Medical via a web-based portal.
16404268|NCT05039424|Procedure|Endoscopic per-oral pyloromyotomy (POP)|Per-oral pyloromyotomy (POP), alternatively knows as gastric per-oral endoscopic myotomy (G-POEM), accomplishes longitudinal division of the pylorus using an endoscope. This procedure involves utilizing endoscopic electrosurgical knife to make an incision in the gastric mucosa and develop a submucosal tunnel to visualize the pyloric ring. The pyloric ring is divided longitudinally, and the mucosotomy incision is sealed with endoscopic clips.
16404269|NCT05039424|Procedure|Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption|While under general anesthesia, a standard gastroscope is introduced and a diagnostic upper endoscopy is performed. The operator talks through the procedure steps as if completing POP. The gastroscope is withdrawn and the patient is extubated.
16404270|NCT05037617|Drug|Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).|"At the intervention site (Foothills Medical Centre), for participants who consent to being part of the trial, once a patient is found to be >= 6 cm dilation, the study medication will be initiated. Pharmacy will make up identical vials of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician.
~The intervention will be continued until delivery unless contractions decrease to less than 2 in 10 minutes or if no further cervical dilation is noted 4 hours after discontinuation."
16404271|NCT05037149|Drug|STP707|Investigational Product
16404272|NCT05037149|Drug|STP707|Investigational Product
16404273|NCT05037149|Drug|STP707|Investigational Product
16404274|NCT05037149|Drug|STP707|Investigational Product
16404275|NCT05037149|Drug|STP707|Investigational Product
16404286|NCT05035173|Other|Survivorship Clinic Assessments|"Patients will visit in person the Survivorship Clinic at the baseline and end of the study (12-month) at the ORCHID center in the Cork University Hospital (Cork, Ireland).
~During these visits, baseline and end of the study assessments will be made. Patients will receive routine standard information, a care plan and resources about survivorship at the baseline visit."
16404287|NCT05035173|Other|Survivorship Clinic Nurse Resource|"Patients will receive a Survivorship Personal Treatment Plan by the nurse from the Women's Health Initiative Survivorship Clinic according to the results from the baseline ePROs. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The nurse will undertake an intervention when needed based as per the Trigger system (developed form ePROs responses) or clinical judgement.
~- ePRO Symptom Survey Instrument (nurse questions): A core list of symptoms/adverse events that are identified including gastrointestinal, attention/memory, pain, fatigue and insomnia, mood-emotional distress/depression, anxiety, fear of cancer recurrence, gynaecological, urinary, sexual issues, hot flashes."
16404288|NCT05035173|Other|Survivorship Clinic Dietitian Resource|"Patients will receive Diet Education and Personalised Nutrition Counselling by the dietitian from the Women's Health Initiative Survivorship Clinic at the baseline. In addition to that, each 2 months for a period of 12 months, the patient will be answering ePROs. The dietitian will undertake an intervention when needed as per the Trigger system (developed form ePROs responses) or clinical judgement.
~- ePRO Symptom Survey Instrument (diet questions): nutritional risk (lack of appetite; worry regarding weight loss; worry regarding weight gain), weight, and exercise."
16404289|NCT05034874|Drug|IXT-m200|IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.
16404290|NCT05034874|Other|Placebo|Saline
16404291|NCT05033639|Drug|Melatonin 6 MG|Melatonin is an endogenously produced indolamine principally synthesized in the pineal gland from serotonin. It is described as a ubiquitous molecule which plays a vital role in the physiologic function of the body. Melatonin, also known as N-acetyl-5-methoxytryptamine which has a a) immunomodulator; b) free radical scavenger; c) prevention of oxidative stress and d) anti-inflammatory7-10.
16404292|NCT05033639|Other|Breast Milk|Naturally occurring milk from the mother of the infant.
16404293|NCT05032014|Other|M9|one times a day during the whole treatment
16404294|NCT05032014|Other|placebo|placebo
16404295|NCT05031806|Drug|iNexin™ (0.08% aCT1)|36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.randomized 7:3 for each active concentration to Vehicle.
16404296|NCT05031806|Drug|iNexin™ (0.4% aCT1)|36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.
16404297|NCT05031806|Drug|iNexin™ (2.0% aCT1)|36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.
16404298|NCT05031806|Drug|Vehicle (eye drop formulation without aCT1)|"36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.
~During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2)."
16404299|NCT05031182|Procedure|Laparoscopy|The hysterectomy is performed by laparoscopy as described in the EMC.
16404300|NCT05031182|Procedure|vNOTES|The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.
16404301|NCT05030376|Dietary Supplement|intraileal infusion|intraileal glucose or intraileal saline infusion
16404302|NCT05030272|Behavioral|Learn to Quit App|A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms.
16404303|NCT05030272|Behavioral|Brief advice|Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt.
16404304|NCT05030272|Drug|Nicotine patch|All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
16404305|NCT05030272|Behavioral|Smartphone coaching|Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app.
16404306|NCT05030272|Drug|Nicotine gum|Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
16404322|NCT05020496|Drug|Diphenylcyclopropenone (DPCP)|Drug will be applied topically on the skin. It will cause contact hypersensitivity in patients
16404323|NCT05019430|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and zolmitriptan.
16404324|NCT05019430|Drug|Placebo oral capsule|The pharmacodynamic effects of placebo will be determined.
16404325|NCT05019430|Drug|Zolmitriptan|The pharmacodynamic effects of zolmitriptan maintenance will be determined.
16404329|NCT05017779|Behavioral|Unstuck & On Target: High School|Unstuck & On Target: High School (UOT:HS) is a group-based curriculum for high school students that targets executive function skills using Cognitive Behavior Therapy (CBT) techniques. UOT:HS focuses on key functions needed for adult success, such as: self-advocacy, flexibility, time management, motivation, goal setting, developing plans, monitoring progress. Guided practice begins with concrete interventionist support and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support. Lessons are delivered by school personnel within the school setting. Home extension activities are provided to parents.
16404330|NCT05017779|Other|Treatment as Usual|Participants in schools assigned to the Treatment as Usual (TAU) condition will continue to receive the standard school-based IEP accommodations and school supports that would typically be provided. Data will be collected on the types of supports TAU schools offer, and what supports TAU students receive.
16404340|NCT05009966|Drug|SYSA1801 for injection|SYSA1801 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.
16404348|NCT05004896|Drug|Ketamine Hydrochloride|50 patients will receive ketamine hydrochloride, over four infusions, flexibly dosed between 0.5 mg/kg to 0.75 mg/kg
16404349|NCT05004896|Drug|Midazolam Hydrochloride|50 patients will receive midazolam hydrochloride, over four infusions, flexibly dosed between 0.02 mg/kg to 0.03 mg/kg
16404350|NCT05004857|Behavioral|Book reading|Prior to the first session, a research assistant will place electrodes on the infant and mother so that they study team can gather autonomic nervous system (ANS) response (sympathetic and parasympathetic) non-invasively using MindWare Portable Lab System (MindWare Technologies, Gahanna, Ohio). These electrodes will remain on the infant and mother throughout each session and be removed via adhesive removing pads following each session's data collection. This will minimize discomfort to both parties secondary to electrode removal and minimize risk of skin irritation by leaving electrodes in place for a prolonged period of time. Additional observational data before and after the reading sessions will be collected by the research assistant, including but not limited to: where the session is conducted (mother's arms, bassinet), activity level, vital signs, and any other observed behaviors throughout the session.
16404351|NCT05004662|Behavioral|Smartphone-delivered automated treatment|An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant
16404352|NCT05004662|Drug|Nicotine patch|Participants will be provided with a 10-week supply of nicotine patches
16404353|NCT05004662|Behavioral|Counceling|Phone counseling with the Florida Quitline
16404354|NCT05004662|Drug|Nicotine lozenge|Participants will be provided with a 10-week supply of nicotine lozenges
16404359|NCT04997733|Drug|Fecal Microbiota Transplantation (FMT)|"The colonoscopy for FMT will be planned 1 week +/- 7 days after stopping adalimumab and 6 weeks +/- 7 days after stopping infliximab. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of saline (NaCl 0.9%), (FMT vehicle in the terminal ileum or the colon.
~At W12 and W24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain 0.8g of stools by visit)."
16404360|NCT04997733|Drug|Sham-transplantation (placebo)|"The colonoscopy for sham-transplantation will be planned 1 week +/- 7 days after stopping adalimumab and 6 weeks +/- 7 days after stopping infliximab. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either sham transplantation (frozen preparation of NaCl 0.9% with 10% glycerol) in the terminal ileum or the colon.
~At S12 and S24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain placebo)."
16404361|NCT04995237|Behavioral|PPP|Participants will be provided with a weekly bag of produce, information about how to cook the produce, assistance in setting quality of life goals, and individualized teaching to support meeting participant's set goals.
16404362|NCT04988841|Drug|MaaT013|study is an experimental drug , produced by MaaT Pharma, and composed of pooled-donor, full-ecosystem intestinal microbiome (455 species approximately against 274 on average)
16404363|NCT04988841|Drug|Ipilimumab|Anti cytotoxicT-lymphocyte-associated protein 4 ( immunothérapy)
16404364|NCT04988841|Drug|Nivolumab|AntiPD1 ( immunothérapy)
16404365|NCT04988841|Drug|MoviPrep|Osmotic laxative solution : patients take a single dose of two liters of Moviprep® or equivalent the night before the first administration of experimental treatment (Fecal microbiota transfer or placebo)
16404366|NCT04988841|Drug|Normacol|hypertonic enema solution
16404367|NCT04988841|Drug|Placebo of Maat013|expérimental drug placebo of MaaT013
16404371|NCT04987177|Other|Workload of Manual Wheelchair Propulsion|Participants will complete 20 one-minute manual wheelchair propulsion bouts. Each one minute propulsion bout will be followed by a 2 minute rest period. Each propulsion bout will be at a different workload. After every 10 propulsion bouts, participants will be provided with an extended rest period (5 to 30 minutes). For each participant, the maximum workload to be tested is based on their estimated maximum workload. Estimate maximum workload is based on the HR-Workload relationship documented during a prior sub maximal test to 80% of age adjusted maximum heart rate.
16404372|NCT04985136|Drug|camrelizumab；Rivoceranib|Camrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD)
16404373|NCT04985136|Drug|Rivoceranib|Rivoceranib mesylate (750 mg, QD, po)
16404374|NCT04985136|Drug|Sorafenib|Sorafenib tosylate (400 mg, twice a day (BID), po)
16404375|NCT04985136|Drug|Regorafenib|Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)
16404376|NCT04984811|Drug|efineptakin alfa|1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
16404377|NCT04984811|Drug|Atezolizumab|1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
16404378|NCT04983888|Drug|Obinutuzumab|1g IV on day one and 1 g IV on day 15, followed by identical course at month 6
16404379|NCT04983368|Drug|Xanamem® 5 mg|"Oral Xanamem® (UE2343) capsules 5 mg, administered orally once daily."
16404380|NCT04983368|Drug|Placebo|Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.
16404381|NCT04983368|Drug|Xanamem® 10 mg|"Oral Xanamem® (UE2343) capsules 10 mg, administered orally once daily."
16404382|NCT04979442|Drug|RAIN-32|260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
16404383|NCT04979442|Drug|Trabectedin|1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
16404384|NCT04975308|Drug|LY3484356|Administered orally.
16404385|NCT04975308|Drug|Exemestane|Administered orally.
16404386|NCT04975308|Drug|Fulvestrant|Administered IM.
16404387|NCT04975204|Drug|TQB3909 Tablets|TQB3909 is an inhibitor targeting BCL-2 protein
16404388|NCT04974164|Biological|Inactivated COVID-19 Vaccine|Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen
16404389|NCT04969302|Diagnostic Test|Follow-up|"The primary outcome of this study was SSI within 30 days of surgery, as defined by the Centers for Disease Control and Prevention. Secondary outcomes were identification of the causative organism, and investigation of clinical factors such as body mass index (BMI), operation time, days of hospitalization, etc. that may be associated with SSI.
~All patients were followed up for SSI until discharge from hospital and at the outpatient visits. SSI surveillance data forms were used for the collection of primary and secondary outcome data.
~SSI rates and distribution of identified micro-organisms for each group will measured"
16404390|NCT04968236|Other|Deep Dry Needling|In-and-out into different directions technique to encounter sensitive spots in an MTrP region.
16404391|NCT04968236|Other|Superficial Dry Needling|This technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ.
16404392|NCT04968236|Other|passive stretching|Type of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion.
16404393|NCT04967560|Device|deep brain stimulation|Both group will undergo the DBS surgery. Four weeks after surgery, all patients will visit the clinic with the DBS stimulation in the 'off' state for initial programming of electrical parameters for stimulation. At double-blind visit, the electrical stimulation will be actually 'turned on' immediately after the programming in true-stimulation group, while turn-off in the control group.
16404394|NCT04964843|Drug|N-acetylcysteine|N-acetylcysteine is an FDA approved medication that is used to treat acetaminophen overdose.
16404395|NCT04964843|Drug|Placebo|Placebo
16404396|NCT04961827|Behavioral|Self-efficacy based images through instant messaging|A total of 6 images will be sent to participants via instant messaging. Images will utilize concepts in the Theory of self-efficacy to increase dietary self-efficacy among participants and hence improve dietary quality beyond that of conventional nutrition counseling.
16404397|NCT04961827|Behavioral|Knowledge based images through instant messaging|A total of 6 images will be sent to participants via instant messaging. Images will consist of information covered in nutrition counseling sessions, such as those related to serving sizes.
16404398|NCT04958967|Drug|Furmonertinib 240mg|treated subjects will receive Furmonertinib 240mg/day
16404399|NCT04958967|Drug|Furmonertinib 160mg|treated subjects will receive Furmonertinib 160mg/day
16404400|NCT04955236|Drug|Partial scalp block|"Partial scalp blocks will be performed bilaterally after assuming the prone position.The Greater occipital will be blocked by injecting 3ml of local anaesthetic at a point half way between the mastoid process the external occipital protuberance along the superior nuchal line, medial to the occipital artery. The Lesser occipital nerve will be blocked by injecting 3ml of local anaesthetic infiltration along the superior nuchal line, 2.5 cm lateral to the greater occipital nerve block. The greater occipital nerve block also will cover the third occipital nerve due to the close location of the two nerves.
~A placebo infusion (normal saline) will be administered at the same rate as fentanyl infusion in the active comparator arm(1 µg/kg/hr.)."
16404401|NCT04955236|Drug|Fentanyl|1µg/kg/hr. of intravenous fentanyl infusion will be administered. A syringe filled with 20 ml of normal saline will be prepared and 3 ml of normal saline will be injected at the same points of the partial scalp block previously described
16404402|NCT04953650|Behavioral|Intermittent fasting|The intervention group is required to perform intermittent fasting for two days. The intermittent fasting method for this group will mimic the Sunnah Muslim fasting; they are allowed to consume food and calorie water without restriction in between dusk and dawn. During the five ad libitum days, they are allowed to have a variety of foods and drinks. Subjects will be informed about healthy food choices; choosing low-fat meat and dairy options, increasing fruit and vegetable intake.
16404403|NCT04953650|Other|No intervention|The control group will receive education training at the baseline as well, regarding blood pressure and nutrition. They will have usual exercise prior to the intervention. Furthermore, the group will have equal health education through health promotion leaflets which have been issued by the ministry of health.
16404404|NCT04952350|Drug|Atorvastatin 40 Mg Oral Tablet|Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.
16404405|NCT04952350|Other|Placebo|A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).
16404408|NCT04948892|Other|Prescence of the father during cesarean section in general anesthesia|The father is now present in the OR during cesarean section category 1, instead of waiting outside
16404409|NCT04947579|Drug|CC-99677|Oral
16404410|NCT04947579|Other|Placebo|Oral
16404411|NCT04947124|Drug|QLS-101ophthalmic solution 1%|QLS-101ophthalmic solution 1.0%
16404412|NCT04947124|Drug|QLS-101ophthalmic solution 2%|QLS-101ophthalmic solution 2.0%
16404417|NCT04943289|Biological|DUOC-01|DUOC-01 is a population of cells expanded from donor human umbilical cord blood mononuclear cells. DUOC-01 cells are derived from CB CD14+ monocytes. DUOC-01 will be administered along with hydrocortisone via intrathecal injection.
16404419|NCT04939012|Behavioral|MyPath Intervention|MyPath is a novel patient-centered, reproductive planning decision support tool developed by the research team used to facilitate postpartum contraceptive decision-making among women with SUDs. Designed to facilitate high-quality decisions regarding pregnancy and contraception, MyPath helps women a) review their thoughts about pregnancy and children, b) learn about fertility and preconception health and c) prioritize their preferences for various contraceptive method characteristics (e.g. effectiveness, side effects). As such, MyPath uses a patient-centered approach to help women frame their contraceptive decisions in the context of their goals and health and is a critical first step towards addressing reproductive health inequities among women with SUDs.
16404420|NCT04939012|Behavioral|Usual care|Standard of Care
16404667|NCT04716985|Dietary Supplement|MOLECULAR HYDROGEN|Magnesium Tablet
16404431|NCT04931745|Device|Virtual reality|VR headset will be used 5-10 minutes prior to and during port access
16404432|NCT04931745|Device|Tables distraction|Tablet distraction will be used 5-10 minutes prior to and during port access
16404433|NCT04931745|Other|No or non-technologic distraction|This approach will be used 5-10 minutes prior to and during port access
16404434|NCT04928963|Dietary Supplement|Prolon - FMD|Prolon by L-Nutra is a medically-designed dietary kit providing the food to eat for five days. Day 1 of Prolon provides ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.
16404435|NCT04928664|Drug|Liposomal bupivacaine|Single shot injection of 10ml 1.33% LB; Due to the milky colour of LB, syringe containing the LB will be covered; Followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml NS; The default fixed rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by a black bag; Catheter and pump will be removed on post-operative day 2
16404436|NCT04928664|Drug|Standard bupivacaine|Single shot injection of 10 ml 0.25% SB in ISB; In order to have blinding to the drug injected, syringe containing SB will be covered; followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml 0.2% SB; The default fixed-rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by a black bag; Catheter and pump will be removed on post-operative day 2
16404440|NCT04926857|Other|Non-Interventional|Non-Interventional
16404441|NCT04924140|Drug|Aducanumab|Administered as specified in the treatment arm
16404442|NCT04923594|Drug|mazindol extended release|Dosed orally, once daily for up to 3 weeks
16404443|NCT04923594|Drug|Placebo|Dosed orally, once daily for up to 4 weeks.
16404444|NCT04921722|Drug|Percutaneous sirolimus|We compare topical and oral use of sirolimus in the treatment of superficial complicted vascular anomalies. In experimental group, we administrate percutaneous sirolimus. Drop 5 ml of sirolimus oral solution and 5 g of dressing into the mixed bottle. Apply mixed gel of topical sirolimus to affected area. Use it twice a day for 6 months.
16404445|NCT04921722|Drug|Oral sirolimus|We compare topical and oral use of sirolimus in the treatment of superficial complicted vascular anomalies. In active comparator group, we administrate oral sirolimus. Oral dose of sirolimus is calculated according to body surface area. Take it twice a day for 6 months. Maintain the blood concentration of sirolimus at 5-15ng/ml.
16404446|NCT04919590|Behavioral|This is Quitting|Text message-based intervention for quit vaping support.
16404447|NCT04919590|Other|Assessment only control|Assessment only
16404450|NCT04910750|Device|Pulse oximetry|Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation
16404451|NCT04910750|Device|Clinical Decision Support Algorithm|Tablet-based clinical decision support algorithms, based on guidelines for the assessment and management of sick children under 5 years of age at primary care
16404452|NCT04910568|Drug|Cevostamab|Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles.
16404453|NCT04910568|Drug|Tocilizumab|Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
16404458|NCT04901195|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16404459|NCT04899505|Other|Evaluation on appearance of unpleasant body odors|Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department.
16404460|NCT04899492|Behavioral|Motivational Interviewing (MI)|1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
16404461|NCT04899492|Behavioral|Cognitive Behavioural Therapy (CBT)|6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
16404462|NCT04899492|Behavioral|Hypnotherapy|About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
16404463|NCT04899492|Drug|Nicotine Replacement Therapy (NRT)|All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
16404464|NCT04899271|Drug|Ladarixin|400 mg b.i.d. for 13 cycles of 14 days on/14 days off
16404465|NCT04899271|Other|Placebo|Placebo will be administered orally with the same scheme of administration of LDX to preserve blinding
16404466|NCT04898829|Dietary Supplement|PKU explore|"For 28 consecutive days, participants will take their usual restricted therapeutic diet, either:
~- Replacing their usual second stage concentrated protein substitute with PKU explore
~OR
~- Commencing PKU explore and gradually reducing their Phe-free formula for infants."
16405602|NCT02465060|Drug|Adavosertib|Given PO
16404467|NCT04897776|Device|Central Thalamic Stimulation|Stimulation of the bilateral thalamic CL is a promising approach in human patients to improve conscious arousal. To restore conscious arousal by stimulation of the thalamic intralaminar CL it is necessary to provide bilateral stimulation, placing one lead in each thalamus. Bilateral thalamic CL stimulation was shown previously to improve human conscious arousal and is based on existing research in patients with disorders of consciousness.
16404468|NCT04897776|Device|Hippocampal Stimulation|The hippocampus has been a target for brain stimulation for seizure reduction in epilepsy. While the efficacy of HC stimulation varies considerably among different studies, the surgical procedure and therapeutic electrical stimulation are well tolerated by patients, with few peri-operative complications being reported, and histopathologic analysis not revealing a difference between stimulated and non-stimulated hippocampal tissue (Han et al. 2014)
16404470|NCT04895748|Drug|DFF332|Hif2alpha inhibitor
16404471|NCT04895748|Drug|RAD001|mTOR inhibitor
16404472|NCT04895748|Drug|PDR001|anti-PD-1
16404473|NCT04895748|Drug|NIR178|Adenosine A2A antagonist receptor
16404474|NCT04895735|Biological|Pembrolizumab|Given IV
16404475|NCT04895735|Drug|Pemetrexed Disodium|Given IV
16404476|NCT04895215|Drug|AB-2004|Taken 3 times daily with food
16404477|NCT04895215|Drug|Placebo|Take 3 times daily with food
16404478|NCT04895202|Other|Siponimod|Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod as by swiss label, that have started before inclusion of the patient into the study will be enrolled.
16404479|NCT04890912|Radiation|Conventional Fractionation|Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
16404480|NCT04890912|Radiation|Hypofractionation|Dose prescribed is 30 Gy in 5 fractions (6 Gy per fraction) delivered every other day over 11 days. There will be a minimum of 36 hours and maximum of 96 hours between fractions. The entire course of treatment should be completed within no less than 10 days.
16404484|NCT04888377|Drug|Aspirin|Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.
16404485|NCT04888377|Drug|Placebo|Participant's mothers were administered placebo throughout their pregnancy with the participant.
16404488|NCT04885790|Other|"Respiratory assessment using Spiropalm 6MWT portable spirometry"|"Spiropalm 6MWT portable spirometry will be used during six-minute walk test for evaluation of dynamic hyperinflation and other related ventilatory parameters. The device will also be used as regular spirometry."
16404489|NCT04885790|Other|Evaluation of functional exercise capacity|Functional exercise capacity of patients will be evaluated using six-minute walk test.
16404490|NCT04885790|Other|Evaluation of peripheral muscle strength|Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.
16404491|NCT04885790|Other|Evaluation of chronic cough|The Leicester Cough Questionnaire will be used for evaluating cough.
16404493|NCT04882748|Other|ADAMO|Physical therapy provided with or without the help of a robot
16404494|NCT04875780|Behavioral|Digital diabetes prevention app intervention|"16-week core program consisting of 16 online weekly interactive lessons on diet and physical activity for weight loss. After the completion of the core program, participant can proceed to the 36-week post-core phase. The post-core program provides 8 monthly lessons focusing on maintaining lifestyle habits and weight loss.
~Participants will be guided to use the smartphone app for goal setting and self-monitoring of diet, physical activity and weight loss.
~Participants will be demographically matched into online groups of 10-12 persons. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other."
16404495|NCT04875780|Behavioral|Digital weight loss tracking app intervention|"All participants will be provided the same smartphone app as the intervention group for goal setting and self-monitoring of diet, physical activity and weight loss.
~Participants will be demographically matched into online groups of 10-12 person. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other."
16404496|NCT04875780|Behavioral|Wait-list control (usual care)|Participants in the control group will be invited to have an annual review and blood test at baseline, 4 and 12 months and received general lifestyle advices from a registered nurse at a community clinic.
16404497|NCT04874766|Other|Wingate exercise test and on-ice testing while wearing a face mask|Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask
16404498|NCT04874766|Other|Wingate exercise test and on-ice testing while wearing a sham face mask|Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask
16404499|NCT04869943|Drug|Enobosarm|Oral Enobosarm 9mg per day
16404500|NCT04869943|Drug|Exemestane|Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)
16404501|NCT04866823|Behavioral|Medically Tailored Meals|Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information.
16404504|NCT04866017|Drug|Tislelizumab|100 mg/10 mL. 200 mg Q3W administered by intravenous infusion
16404505|NCT04866017|Drug|Durvalumab|120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL). 10 mg/kg Q2W (or 1500 mg Q4W where the dosage has been approved by a local health authority)
16404506|NCT04866017|Drug|Chemotherapy|Cisplatin, carboplatin, etoposide, paclitaxel, pemetrexed will be administered in accordance with the relevant local guidelines and/or prescribing information/summary of product characteristics
16404507|NCT04866017|Drug|Ociperlimab|300 mg/15 mL. 900 mg Q3W administered by intravenous infusion
16404508|NCT04860297|Biological|mRNA-1273|Sterile liquid for injection
16404511|NCT04858061|Behavioral|Virtual Reality Cue Exposure Therapy|Exposure to alcohol-related cues within virtual environments
16404512|NCT04858061|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy
16404517|NCT04852978|Drug|REGN10933+REGN10987|Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
16404518|NCT04852978|Biological|Moderna mRNA-1273 vaccine|Single intramuscular (IM) injection
16404519|NCT04851873|Genetic|OAV101|Gene Therapy
16404520|NCT04851483|Drug|BAY2328065|Solid Form, Oral administration.
16404521|NCT04851483|Drug|Placebo|Matching placebo of BAY2328065.
16404522|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 µg/dose Product variant D
16404523|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 µg/dose Product variant E
16404524|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 µg/dose Product variant F
16404525|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 µg/dose Product variant G
16404526|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 µg/dose Product variant H
16404527|NCT04850144|Drug|Tiotropium Bromide Monohydrate|Spiriva 18 µg/capsule inhaled via Handihaler
16404528|NCT04850144|Drug|Tiotropium Easyhaler with oral activated charcoal|The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F
16404532|NCT04847063|Drug|Mitomycin C|Arm 2, intraperitoneal (IP) Mitomycin C monotherapy: dosing divided into two 60-mL syringes, 30 mg per syringe. 30 mg will be given at time = 0, and the remaining 10 mg of the dose will be given at time = 60 minutes. Part of Arm 4: Mitomycin C co-therapy 15 mg/m2 for 60 minutes, given at time = 0 with cisplatin
16404533|NCT04847063|Drug|Cisplatin|Part of Arms 3 and 4, intraperitoneal (IP)cisplatin co-therapy: 75 mg/m2 for 60 minutes, mixed in 1 L of 0.9% sodium chloride. For cisplatin-based HIPEC, intravenous sodium thiosulfate given as a loading dose of 7.5 g/m2 in 150 mL 0.9% sodium chloride at the time of introducing cisplatin into the perfusion circuit, followed by a 12-hour pump-based infusion of 25.56 g/m2 in 1 L 0.9% sodium chloride
16404534|NCT04847063|Procedure|Heated Intraperitonial Chemotherapy|Heated Intraperitonial Chemotherapy (HIPEC) with with standardized doses of chemotherapeutic agents as indicated by the subject's Arm assignment
16404535|NCT04847063|Drug|Doxorubicin|Part of Arm 3: intraperitoneal (IP) Doxorubicin co-therapy 15 mg/m2 for 60 minutes, given at time = 0 with cisplatin
16404536|NCT04847063|Drug|Oxaliplatin|Arm 1, intraperitoneal (IP) Oxaliplatin: 200 mg/m2 for 90 minutes, mixed in 250 mL of 5% dextrose solution. For oxaliplatin-based HIPEC, intravenous 5-fluorouracil given at a dose of 400 mg/m2 in 250 mL 0.9% sodium chloride over 10 minutes, co-administered with intravenous leucovorin at 20 mg/m2 in a separate bag of 250 mL 0.9% sodium chloride
16404537|NCT04847063|Drug|5-Fluorouracil|Part of Arm 1, for oxaliplatin-based HIPEC: intravenous 5-fluorouracil given at a dose of 400 mg/m2 in 250 mL 0.9% sodium chloride over 10 minutes, co-administered with intravenous leucovorin at 20 mg/m2 in a separate bag of 250 mL 0.9% sodium chloride
16404538|NCT04847063|Drug|Sodium Thiosulfate|Part of Arms 3 and 4, for cisplatin-based HIPEC: intravenous sodium thiosulfate given as a loading dose of 7.5 g/m2 in 150 mL 0.9% sodium chloride at the time of introducing cisplatin into the perfusion circuit, followed by a 12-hour pump-based infusion of 25.56 g/m2 in 1 L 0.9% sodium chloride
16404539|NCT04846036|Drug|Sonlicromanol|Oral administration of sonlicromanol twice daily
16404540|NCT04846036|Drug|Placebo|Oral administration of matching placebo twice daily
16404541|NCT04844983|Drug|STP705|The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.
16404542|NCT04844983|Other|Placebo Saline|Normal Saline
16404543|NCT04844840|Drug|STP705|STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively
16404544|NCT04844840|Other|Placebo|Saline
16404548|NCT04841512|Biological|XT-150|non-viral Plasmid DNA encoding an IL-10 variant transgene
16404549|NCT04840602|Drug|Ibrutinib|Given PO
16404550|NCT04840602|Biological|Rituximab|Given IV
16404551|NCT04840602|Drug|Venetoclax|Given PO
16404552|NCT04840472|Drug|111I-n panitumumab|Imaging Agent
16404553|NCT04840472|Procedure|Single photon emission computed tomography/computed tomography (SPECT/CT) scans|Day 1 to 5 (Day of Surgery inclusive)
16404554|NCT04839354|Drug|Arginine Hydrochloride|One-time L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID)
16405603|NCT02465060|Drug|Afatinib|Given PO
16404556|NCT04824547|Other|exercise|All exercises programs will applied two sessions per week, totally eight week..
16404557|NCT04821375|Drug|bazedoxifene plus conjugated estrogens|6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.
16404558|NCT04821141|Drug|Bazedoxifene and Conjugated Estrogens|BZA (20 mg) plus CE (0.45 mg) taken together once daily
16404565|NCT04816591|Device|Experimental: Interventional Cohort: Treatment Arm|Standard of Care Surgery + Embolization
16404566|NCT04816591|Other|Active Comparator: Interventional Cohort: Control Arm|Standard of Care Surgery Only (Control)
16404567|NCT04816591|Device|Experimental: Observational Cohort: Treatment Arm|Standard of Care Medical Management + Embolization
16404568|NCT04816591|Other|Active Comparator: Observational Cohort: Control Arm|Standard of Care Medical Management Only (Control)
16404570|NCT04814628|Procedure|scenario 1 : pre-oxygenation with a face mask held by the anaesthetist|"the face mask is held by the anaesthetist (reference technique) to obtain effective pre-oxygenation for Oxygen Reserve Index (ORI) which has reached a plateau value for more than 10 seconds. All the usual supplies and medicines are available and in the same place as usual.
~The sequence is as follows:
~Patient lying on the operating table, start of the stopwatch
~Opening of the computerized anaesthesia file
~Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
~Preparation of the hypnotic (propofol or thiopental, as desired)
~Preparation of curare (succinylcholine or rocuronium, as desired)
~Pre-oxygenation of the patient with the face mask held by the participating anaesthetist
~Waiting for an ORI which has reached a plateau value for more than 10 seconds
~Conditions for general anaesthesia met for the participating anaesthetist
~End of simulation, stopwatch stop"
16404571|NCT04814628|Procedure|scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation|"one anaesthetist is in charge of the simulated patient (volunteer), face mask held by the volunteer for pre-oxygenation for ORI which has reached a plateau value for more than 10 seconds All the usual supplies and medicines are available and in the same place as usual.
~The sequence is as follows:
~Patient entering the operating room, patient lying on the operating table, start of the stopwatch
~Opening of the computerized anaesthesia file
~Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
~Preparation of the hypnotic (propofol or thiopental, as desired)
~Preparation of curare (succinylcholine or rocuronium, as desired)
~Face mask held by the patient for pre-oxygenation
~Waiting for an ORI which has reached a plateau value for more than 10 seconds
~Conditions for general anaesthesia met for the participating anaesthetist
~End of simulation, stopwatch stop"
16404572|NCT04814628|Procedure|scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation|"All the usual supplies and medicines are available and in the same place as usual.
~The sequence is as follows:
~Patient entering the operating room, patient lying on the operating table, start of the stopwatch
~Opening of the computerized anaesthesia file
~Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
~Preparation of the hypnotic (propofol or thiopental, as desired)
~Preparation of curare (succinylcholine or rocuronium, as desired)
~THRIVE for pre-oxygenation
~Waiting for an ORI which has reached a plateau value for more than 10 seconds
~Conditions for general anaesthesia met for the participating anaesthetist
~End of simulation, stopwatch stop"
16404573|NCT04814628|Procedure|scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist|"All the usual supplies and medicines are available and in the same place as usual.
~The sequence is as follows:
~Patient entering the operating room, patient lying on the operating table, start of the stopwatch
~Opening of the computerized anaesthesia file
~Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
~Preparation of the hypnotic (propofol or thiopental, as desired)
~Preparation of curare (succinylcholine or rocuronium, as desired)
~Pre-oxygenation of the patient with the face mask held by the participating anaesthetist or nurse anaesthetist
~Waiting for an ORI which has reached a plateau value for more than 10 seconds
~Conditions for general anaesthesia met for the participating anaesthetist
~End of simulation, stopwatch stop"
16404574|NCT04812808|Drug|Bazedoxifene 20 mg|"Bazedoxifene will be administered during the duration of the study in the experimental arm together with chemotherapy.
~Prophylactic rivaroxaban (Xarelto®) 10 mg per day orally will be added to avoid thromboembolic events."
16404575|NCT04808843|Drug|Dienogest (BAY86-5258, Visanne)|Following the physicians' decision.
16404576|NCT04808505|Biological|Cipaglucosidase alfa (ATB200)|Participants received Cipaglucosidase Alfa (ATB200) co-administered with Miglustat (AT2221) capsules
16404577|NCT04808505|Drug|Miglustat (AT2221)|Participants received Cipaglucosidase Alfa (ATB200) co-administered with Miglustat (AT2221) capsules
16404579|NCT04805671|Drug|ADG20|Single dose of ADG20
16404580|NCT04805671|Drug|Normal saline|Single dose of normal saline
16404591|NCT04797442|Drug|WST01 strain product|orally given WST01 strain product, added onto lifestyle. The specific ingredients are the optimized Akkermansia muciniphila WST01 strain powder with maximum live bacteria of 5*10^10 CFU/g (1 g/pack, 3 packs QD, 20-30 min after breakfast)
16404592|NCT04797442|Drug|placebo powder|orally given placebo powder (the specific ingrdients are the excipients of the WST01 strain powder), added onto lifestyle. (3 packs of placebo powder QD, 20-30 min after breakfast)
16404593|NCT04796870|Other|Online Brain and Balance Training Program|The intent of the intervention is to encompass cardiovascular conditioning, cognitive performance and balance performance improvements. To promote cardiovascular conditioning the exercises are structured to keep the participant in motion while maintaining an elevated heart rate using techniques such as squats, marching and upper extremity movements. The video provides adaptations to increase or decrease the challenge based on subject ability. To promote cognitive performance, participants will be asked to complete simple and complex cognitive tasks, such as arithmetic, spatial memory recall and attention while completing the physical exercises. To promote balance performance, the videos include single limb stance and weight shifting tasks. Videos are presented in a progressively challenging manner for all domains.
16404594|NCT04793412|Device|Cochlear Implant|Cochlear implantation of a device from one of the three manufacturers available in the US.
16404595|NCT04791735|Procedure|Laparoscopy|"Installations of the patient: the position of the patient will depend on both extent of resection and location of the lesion.
~Absence of laparotomy with the exception of the extraction of the resected specimen and absence of costal retractors.
~Use of laparoscopic specific devices:
~Use of multiple (3-7) ports depending on the operator's preference and technical difficulty (mainly 5-6 ports for major liver resection).
~Use of a laparoscopic camera system with 0° or 30°
~Use of a dedicated laparoscopic ultrasound probe.
~Use of specific laparoscopic devices for coagulation, parenchymal transection and sealing.
~Placement of the resected specimen in a plastic bag and extraction without fragmentation, depending on the surgeon's preferenceand the diameter of the resected specimen"
16404596|NCT04791735|Procedure|Laparotomy|"Installation of the patient: patients will be placed in supine position, the surgeon operating on the right side of the patient and the assistant standing on the left side.
~Incision: the type of incision will depend on both the nature of the resection and the operator's preference. Various incisions such as bi subcostal incision, J-shaped incision, right subcostal incision and midline incision can be used.
~Use of open surgical instruments and devices for coagulation and parenchymal transection. These may include the crush-clamp technique or ultrasonic dissection for parenchymal transection, bipolar coagulation, clips, sutures or open vascular stapler for hemostasis and biliostasis.
~Methylene blue injection through the cystic drain to rule out biliary leakage will be performed depending on the surgeon's preference."
16404597|NCT04786951|Behavioral|Attentional Bias Modification Training|Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions and five sessions of Attentional Bias Modification Training.
16404598|NCT04786951|Behavioral|VR-based body exposure|Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions
16404599|NCT04786951|Behavioral|Cognitive-behavioral therapy|Usual cognitive-behavioral treatment (CBT) sessions.
16404600|NCT04784845|Biological|N. lactamica Y92-1009|Lyophilised N. lactamica reconstituted in phosphate-buffered saline
16404601|NCT04774575|Biological|biomarker-guided strategy|Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed
16404602|NCT04768972|Drug|ION363|ION363 will be administered by IT bolus injection.
16404603|NCT04768972|Drug|Placebo|Placebo will be administered by IT bolus injection.
16404604|NCT04763941|Diagnostic Test|CDR assessment face-to-face|The assessment of the CDR is administered once by a psychologist with the patient and his caregiver.
16404605|NCT04762199|Drug|Flt3/MerTK Inhibitor MRX-2843|Given PO
16404606|NCT04762199|Drug|Osimertinib|Given PO
16404621|NCT04759144|Device|CamAPS FX using faster insulin aspart|"CamAPS FX closed loop system comprises:
~Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
~Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
~An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
~Cloud upload system to monitor CGM/insulin data"
16404622|NCT04759144|Device|CamAPS FX using standard insulin aspart|"CamAPS FX closed loop system comprises:
~Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
~Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
~An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
~Cloud upload system to monitor CGM/insulin data"
16404623|NCT04754984|Behavioral|Pelvic floor workshop|Physiotherapist-led workshop on managing pelvic floor symptoms
16404624|NCT04753164|Drug|ACT-539313|ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
16404668|NCT04716985|Dietary Supplement|PLACEBO MAGNESIUM|Magnesium carbonate tablet
16404625|NCT04753164|Drug|Placebo|Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
16404631|NCT04747548|Behavioral|Kurbo Only|Kurbo is a structured behavioral weight management program for youth that focuses on diet, physical activity and mindset skills and is based on the traffic light diet developed at Stanford University. The dietary approach is based on creating an energy deficit diet to produce weight loss while also being attentive to the quality of the calories consumed. Foods are categorized into the colors of a traffic light signal based on their nutritional and caloric content, such that youth are encouraged to eat more of green and yellow foods, and less of red foods. Participants will log their daily food intake and self-monitor dietary and physical activity behaviors, incorporating behavior substitution and habit formation. Participants will also have 15 minute weekly individualized coaching sessions.
16404632|NCT04747548|Behavioral|Kurbo + PolyRules!|In addition to Kurbo, participants will be asked to engage in daily cognitive training using the PolyRules! app for three months. They will be instructed to start with 20-min of daily cognitive training and to progressively increase their training time to 30-min.
16404633|NCT04746404|Behavioral|Emotional Skills Development Program|Emotional Skills Development Program (positive psychology)
16404634|NCT04743921|Device|Reparel Knee Sleeve|Patients who are recommended for non-operative management of knee osteoarthritis and have been consented in clinic to participate in the study will be given a Reparel™ knee sleeve to wear for knee osteoarthritis management. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Reparel™ knee sleeve, patients will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows: wear the sleeve as much as they possibly can; not change their usual activities and diet during the time they are on this study; record in a diary the number of hours sleeve was worn per day; record any adverse eﬀects or discomfort due to sleeve use; refrain from altering treatment for knee osteoarthritis.
16404635|NCT04741139|Drug|Acetaminophen and Diphenhydramine Only Product|Using a scheduled medication regimen of diphenhydramine and acetaminophen following IVIG medication to evaluate feasibility of enrollment, medication adherence, side effects related to study medication and IVIG.
16404638|NCT04740736|Procedure|Saline Infusion|Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
16404647|NCT04738292|Drug|Onapristone|Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
16404648|NCT04738292|Drug|Fulvestrant|Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
16404649|NCT04737265|Other|Biomarker Guided Intervention|NTproBNP above the upper limit of normal will trigger the initiation of heart failure therapy with counseling from a study investigator based on protocol specified algorithm.
16404650|NCT04736173|Drug|Zimberelimab|Zimberelimab is a fully human anti-PD-1 monoclonal antibody
16404651|NCT04736173|Drug|Domvanalimab|Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
16404652|NCT04736173|Drug|Carboplatin|Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
16404653|NCT04736173|Drug|Pemetrexed|Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
16404654|NCT04736173|Drug|Paclitaxel|Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
16404658|NCT04730635|Drug|Donepezil|Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.
16404659|NCT04730635|Drug|Placebo|Dose matched placebo capsule QD, orally for Days 1-56.
16404663|NCT04723355|Device|QuoreOne Holter system|The participant will use the QuoreOne Holter system simultaneously with the Cardiolight Holter system for 24 hours.
16404664|NCT04723355|Device|Cardiolight Holter system|The participant will use the Cardiolight Holter system simultaneously with the QuoreOne Holter system for 24 hours.
16404669|NCT04715750|Drug|[18F]-PI2620|[18F]PI-2620 is a radioactive diagnostic agent being developed for the indication of PET imaging of the brain to detect tau pathology in adult patients who are being evaluated for neurodegenerative decline. All patients will receive two administrations of [18F]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).
16404670|NCT04713826|Drug|BAY2586116|160 µg, nasal spray administration.
16404671|NCT04713826|Drug|Placebo|Placebo matching BAY2586116, nasal spray administration.
16404672|NCT04710199|Drug|Maraviroc experimental group|300-milligram dose of the drug two times daily , oral way. During 14 days.
16404673|NCT04710199|Other|Standard treatment|It is based on the treatment protocol for hospitalized COVID-19 patients and that will depend on the clinical status of the patient.
16404674|NCT04708418|Biological|Pembrolizumab|Given IV
16404675|NCT04708418|Procedure|Surgical Procedure|Undergo surgery
16404676|NCT04708418|Drug|VLP-encapsulated TLR9 Agonist CMP-001|Given SC or intratumorally
16404677|NCT04708067|Drug|Bintrafusp Alfa|Given IV
16404678|NCT04708067|Procedure|Biopsy|Undergo biopsy
16404679|NCT04708067|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
16404680|NCT04708041|Biological|9vHPV vaccine|9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
16404681|NCT04699630|Drug|U3-1402|All subjects will receive 5.6 mg/kg U3-1402 intravenously on day 1 of every 3 weeks
16404683|NCT04692220|Other|Detection of Adverse Drug Events or Drug-Related Problems|Detection of Adverse Drug Events or Drug-Related Problems
16404684|NCT04689490|Diagnostic Test|Cardiopulmonary exercise test|Only diagnostic tests
16404685|NCT04683510|Other|Navigation - Study Specific - Researcher Voice|The intervention is delivered over the telephone
16404686|NCT04683510|Other|Navigation - Study Specific - Cancer Survivor Voice|The intervention is delivered over the telephone
16404687|NCT04683510|Other|Navigation - Research General - Researcher Voice|The intervention is delivered over the telephone
16404688|NCT04683510|Other|Navigation - Research General - Cancer Survivor Voice|The intervention is delivered over the telephone
16404689|NCT04683510|Other|Brochure - Study Specific - Researcher Voice|The invention is mailed to the participant in a brochure.
16404690|NCT04683510|Other|Brochure - Study Specific - Cancer Survivor Voice|The invention is mailed to the participant in a brochure.
16404691|NCT04683510|Other|Brochure - Research General - Researcher Voice|The invention is mailed to the participant in a brochure.
16404692|NCT04683510|Other|Brochure - Research General - Cancer Survivor Voice|The invention is mailed to the participant in a brochure.
16404693|NCT04678947|Behavioral|Baxter Retching Faces (BARF) scale|"Pictorial scale that was developed for use by pediatric patients in self-reported assessments of nausea severity
~A patient will respond by choosing a picture or a number on the scale that best represents how they feel. The patient may speak or simply point to their response. While the numbers 0-2-4-6-8-10 are listed alongside the pictures, patients are also allowed to choose in between or odd numbers. If a patient is unwilling to participate, the patient's parent or guardian may serve as their proxy and choose a number for them, based off of their symptoms.
~The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea)."
16404694|NCT04673630|Biological|Tezepelumab|Single dose subcutaneous injection
16404695|NCT04672967|Diagnostic Test|BioROSA MAP test|The BioROSA MAP test is a blood test that is being developed to predict ASD risk
16404696|NCT04671667|Drug|Carboplatin|Given IV
16404697|NCT04671667|Drug|Cisplatin|Given IV
16404698|NCT04671667|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16404699|NCT04671667|Biological|Pembrolizumab|Given IV
16404700|NCT04671667|Radiation|Proton Beam Radiation Therapy|Undergo PBRT
16404701|NCT04669808|Drug|STP705|Dry powder for intra-and peri-lesional injection.
16404702|NCT04669691|Biological|H5N1 antigen combined with MF59 adjuvant|Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart
16404703|NCT04663867|Device|AngioSafe Peripheral CTO Crossing System|The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.
16404704|NCT04657263|Other|Vaccine coverage assessment|Vaccine coverage assessment
16404705|NCT04656028|Genetic|Genetic Testing|DNA is extracted using the QIAamp® DNA Blood Mini Kit (Qiagen, Germany). The DNA concentration is measured on a Qubit 4.0 fluorometer (Thermo Fisher Scientific, USA (TFS)). NGS is performed on Nextseq 550 (Illumina, San Diego, CA, USA). The library preparation is performed using the SeqCap EZ Prime Choice Library kit (Roche, Basel, Switzerland). The Roche panel is used, consisting of 244 (CDS + 25 bp padding) genes including LDLR, APOB, and PCSK9. Reads are aligned to the reference genome (GRCh37). Sequencing analysis resultes in fastq files. Data processing is performed with BWA, Picard, bcftools, GATK3 and generally followed the GATK best practices for variant calling. For clinical interpretation, genetic variants with frequencies in the gnomAD database <0.5% are selected. The pathogenicity of variants is assessed according to the ACMG / AMP2015 guidelines. The identified SNPs are validated by Sanger sequencing (3500 DNA Analyzer, TFS).
16404706|NCT04656028|Behavioral|Motivational Counseling|"Motivational counseling will be carried out during Visit 2 and in one month after Visit 2 by certified psychologist with taking into account the results of the psychodiagnostic survey conducted at the first and second visits.
~The goals of motivational counseling:
~Increasing motivation for a healthy lifestyle;
~Increasing adherence to treatment;
~Increased motivation to invite relatives for cascade screening. Motivational counseling will be carried out using methods of motivational interviewing, transtheoretical model of changes, cognitive-behavioral therapy, extended preventive counseling."
16404707|NCT04656028|Diagnostic Test|Lipid analysis|Assessment of total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, alanine aminotransferase.
16405604|NCT02465060|Drug|Afatinib Dimaleate|Given PO
16404708|NCT04656028|Other|Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)|All patients will be prescribed ezetimibe and statins (atorvastatin / rosuvastatin) at the maximum dosage. If somebody has an intolerance to atorvastatin, the drug will be replaced with rosuvastatin and vice versa. In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab). After receiving the results of the lipid spectrum, ALT, if necessary, the lipid-lowering therapy may be corrected.
16404709|NCT04656028|Other|Visit 1|"Visit 1: initially (on enrollment) - informed consents signing; lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires. After this visit patients are randomized to groups with or without genetic testing and then randomized to groups with or without motivational counseling.
~Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform, a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days."
16404710|NCT04656028|Other|Visit 2|"Visit 2 (in 2-3 months): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid lowering-therapy and lifestyle; filling all questionnaires. Patients from the group with genetic testing will get the result of this genetic testing. Patients from the group with motivational counseling will get two consultations with a psychologist (motivational counseling on lifestyle modification) during Visit 2 and in one month after Visit 2.
~Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days"
16404711|NCT04656028|Other|Visit 3|"Visit 3 (in 3 months after Visit 2): lipid blood tests, patient data gathering, and consultation of cardiologist-lipidologist for optimization of lipid-lowering therapy and lifestyle; filling all questionnaires.
~Each visit consists of two patient's attendances to the medical center. At the first attendance, it is planned to take blood for analysis, fill out questionnaires; at the second attendance - to perform a consultation with a cardiologist-lipidologist according to the results of blood analysis. The time interval between two attendances is ≤ 7 days."
16404712|NCT04648696|Drug|Vancomycin CI|The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
16404713|NCT04648696|Drug|Vancomycin II|Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
16404714|NCT04648501|Other|Dual-task training|Dual-task (CIBT- experimental) group participants will receive 10 minutes of warm up, 40 minutes of CIBT training and 10 minutes of cool down exercises. CIBT program includes performing four types of cognitive tasks during sit to stand, standing with feet apart, one leg, tandem standing, multidirectional reaching, stair climbing and walking (10 metres) tasks. The four cognitive tasks will include: counting backwards by subtracting 4 numbers (for mental tracking ), naming fruits, vegetables, or animals (for working memory), auditory cues for performing activities, example, perform heel raise when you hear the alphabet H (for improving attention and auditory discrimination), short story telling (for verbal fluency). In addition, falls prevention strategies will be taught.
16404715|NCT04647565|Other|interviews|interviews (human and social sciences)
16404716|NCT04646226|Device|AV graft|The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)
16404717|NCT04646226|Procedure|surgical intervention for creation of a fistula|The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)
16404721|NCT04643184|Other|Management Program|Joint management between the geriatric and cardiology team of the geriatric syndromes and heart failure. Education of the patient and their caregiver, preparing them for the transition of care.
16404726|NCT04639310|Drug|XEN496|XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
16404727|NCT04639310|Drug|Placebo|Placebo sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.
16404728|NCT04633239|Drug|Abemaciclib|Given PO
16404729|NCT04633239|Drug|Olaparib|Given PO
16404730|NCT04628871|Biological|SB-318|No study drug is administered in this study. Subject who received SB-318 in a previous trial will be evaluated in this trial for long-term safety.
16404731|NCT04628871|Biological|SB-913|No study drug is administered in this study. Subject who received SB-913 in a previous trial will be evaluated in this trial for long-term safety.
16404732|NCT04628871|Biological|SB-FIX|No study drug is administered in this study. Subject who received SB-FIX in a previous trial will be evaluated in this trial for long-term safety.
16404733|NCT04628481|Drug|Ladarixin|Oral ladarixin twice a day for 13 cycles
16404734|NCT04628481|Drug|Placebo|Oral placebo twice a day for 13 cycles
16404746|NCT04619199|Diagnostic Test|Blood sample|Blood sample performed at the inclusion and during the follow-up.
16404747|NCT04607850|Biological|ChAdOx1-HPV|Trial vaccine
16404748|NCT04607850|Biological|MVA-HPV|Trial vaccine
16404749|NCT04607850|Biological|Placebo|Saline placebo vaccine
16404750|NCT04606823|Procedure|Minimally invasive surgery|The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
16404751|NCT04606823|Other|Glasgow Benefit Inventory (GBI)|A quality of life-questionnaire is to be completed by the subjects at one occasion.
16404752|NCT04606823|Other|Additional follow-up visits after surgery|There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
16404753|NCT04604548|Drug|Oral administration of 100 mg KH176 twice daily|Drug: KH176
16404754|NCT04602845|Drug|Fentanyl|50ug Fentanyl intravenously
16404755|NCT04602845|Drug|Flurbiprofen|50mg Fentanyl intravenously
16404756|NCT04602845|Drug|Midazolam|2.5mg midazolam in 2ml normal saline intravenously
16404757|NCT04602845|Drug|Remimazolam|3mg Remimazolam in 2ml normal saline intravenously
16404761|NCT04599049|Other|six sessions of online classes and virtual training day camps through Zoom in two days|"The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the AWARD Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
~All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively."
16404762|NCT04596579|Diagnostic Test|SARS-CoV-2 Antibody Analysis|10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.
16404763|NCT04596579|Diagnostic Test|Weck-cel Swab Collection|A Weck-cel swab will be used to collect secretions from the mucosal epithelium
16404764|NCT04596579|Behavioral|Web Based Questionnaire|A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.
16404765|NCT04596202|Behavioral|Supine position|After the infants are treated and fed, they will be given the supine position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period.
16404806|NCT04563143|Other|Novel DBS Stimulation|Stimulation patterns will vary from the standard therapeutic approach in terms of frequency, contact location, and/or temporal pattern.
16404807|NCT04557696|Other|REFLECT Curriculum|Annual quarterly workshops will consist of guest lecturers, role playing, patient panels, coaching, knowledge assessments, Standardized Patient (SP) simulations and debriefing/feedback sessions.
16404766|NCT04596202|Behavioral|Prone position|After the infants are treated and fed, they will be given the prone position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period.
16404767|NCT04596202|Behavioral|Lateral position|After the infants are treated and fed, they will be given the left or right position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period. These processes will continue until the 4 positions are completed. Infants will stay in each position for 2 hours.
16404768|NCT04593264|Other|Self-guided pre-habilitation exercise program|A set of self-guided exercises developed by an athletic trainer to perform at home in order to optimize the knee for ACL repair surgery
16404769|NCT04593264|Other|Traditional pre-habilitation|Pre-habilitation exercise sessions under the direct supervision of a physical therapist.
16404770|NCT04590794|Diagnostic Test|Soluble Urokinase Plasminogen Activator Receptor|Participants will undergo sampling of peripheral venous blood, immediately after admission. Blood samples drawn from all patients and EDTA plasma will be stored at -80° C until later measurement. Plasma suPAR levels will be determined using the suPARnostic® ELISA assay (ViroGates, Denmark), which is based on a simplified double monoclonal antibody sandwich ELISA assay whereby samples and peroxidase-conjugated anti-suPAR are first mixed together and then incubated in anti-suPAR pre-coated micro wells. The recombinant suPAR standards of the kit are calibrated against healthy human blood donor samples. suPAR concentrations are determined as ng/mL plasma.
16404771|NCT04588298|Drug|AZD9833|AZD9833 tablets will be administered orally.
16404772|NCT04588298|Drug|Fulvestrant|Fulvestrant will be administered via IM injection.
16404773|NCT04586751|Other|Pecs block|Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.
16404774|NCT04586751|Other|no Pecs block|no regional block will be performed in this arm
16404775|NCT04585685|Behavioral|Cognitive Processing Therapy|A 12-session cognitive behavioral therapy for posttraumatic stress disorder
16404776|NCT04585685|Behavioral|Self-Compassion Therapy|A 6-session mindfulness based therapy for posttraumatic stress disorder aimed at enhancing self-compassion
16404777|NCT04585035|Drug|D-1553|D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
16404778|NCT04585035|Drug|Other|Standard treatment of solid tumor, NSCLC or CRC
16404782|NCT04583956|Other|Placebo|Risankizumab placebo will be given at an equal volume at the same schedule.
16404783|NCT04583956|Drug|Remdesivir|Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
16404784|NCT04583956|Biological|Risankizumab|Risankizumab is a humanized immunoglobulin (Ig) G1 antagonistic monoclonal antibody (mAb) directed against the p19 subunit of the human cytokine interleukin-23. Risankizumab is formulated in a buffer of 4.4 mM disodium succinate hexahydrate/succinic acid, 225 mM sorbitol, 0.2 mg/mL polysorbate 20, and WFI in a 6R vial.
16404787|NCT04581148|Diagnostic Test|Blood test for IgG antibodies against SARS-CoV-2|Residual blood of inpatients and outpatients will be analyzed anonymous with a quantitative test for the assessment of IgG antibodies against SARS-CoV-2
16404792|NCT04576091|Drug|Elimusertib|Given PO
16404793|NCT04576091|Biological|Pembrolizumab|Given IV
16404794|NCT04576091|Other|Quality-of-Life Assessment|Ancillary studies
16404795|NCT04576091|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16404796|NCT04574830|Other|No Intervention|No Intervention
16404797|NCT04573478|Drug|Atrasentan|Film-coated tablet
16404798|NCT04573478|Drug|Placebo|Film-coated tablet
16404799|NCT04571944|Drug|Suvorexant|Suvorexant administered at a dose of 15 mg QD via oral tablet
16404800|NCT04571944|Drug|Placebo|Suvorexant-matching placebo administered QD via oral tablet
16404802|NCT04567706|Procedure|Biospecimen Collection|Undergo collection of blood and tissue samples
16405205|NCT03837860|Drug|Oxycodone/Ziprasidone|Oxycodone (20mg) plus Ziprasidone (80 mg)
16404808|NCT04552899|Drug|PRM-151|A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
16404809|NCT04552899|Drug|Placebo|Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
16404812|NCT04543643|Drug|Carvedilol|As the third generation of NSBB, carvedilol is more effective in reducing HVPG than propranolol, which is recommended by Baveno VI as the first-line drug for EVB primary prevention.
16404813|NCT04543643|Drug|Berberine|Berberine can regulate the intestinal flora, which is safe and effective in clinical application.
16404814|NCT04543253|Other|MUSE biofeedback|biofeedback through a headband
16404817|NCT04530812|Other|Best Practice|Maintain usual diet
16404818|NCT04530812|Dietary Supplement|Kefir|Consume commercial kefir beverage
16404819|NCT04530812|Other|Quality-of-Life Assessment|Ancillary studies
16404820|NCT04530812|Other|Questionnaire Administration|Ancillary studies
16404832|NCT04526652|Drug|Dexmedetomidine|Evaluating anxiety score in both arms
16404833|NCT04526652|Drug|Placebo|Evaluating anxiety score in both arms
16404834|NCT04516993|Drug|Tenecteplase|Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
16404835|NCT04516993|Drug|nonthrombolysis drug|nonthrombolysis drug
16404836|NCT04505865|Behavioral|Stress Reduction|"The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:
~1) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being."
16404837|NCT04505826|Drug|OP-1250|Complete Estrogen Receptor ANtagonist (CERAN)
16404838|NCT04500548|Procedure|Biospecimen Collection|Undergo collection of tissue samples
16404839|NCT04500548|Biological|Ipilimumab|Given IV
16404840|NCT04500548|Biological|Nivolumab|Given IV
16404841|NCT04500210|Dietary Supplement|Placebo|Placebo in gelatin capsules
16404842|NCT04500210|Dietary Supplement|Turmeric|Turmeric in gelatin capsules
16404843|NCT04499937|Behavioral|Streak incentive|Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with a $0 balance and will earn a fixed amount for each response.
16404844|NCT04499937|Behavioral|Loss-based incentive|Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with the maximum balance and will lose a fixed amount for each response they do not complete.
16404845|NCT04499937|Behavioral|Flat-fee control status quo condition|Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will receive the maximum compensation at the end of the study.
16404846|NCT04499937|Behavioral|Flat-Fitbit control status quo condition|Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will keep the Fitbit at the end of the study.
16404847|NCT04495855|Drug|Dienogest (Visanne,BAY86_5258)|2 mg (once a day), oral, tablet.
16404848|NCT04493190|Procedure|Scapular control training|Participants in this group will learn how to maintain normal scapular position at first. Then they will progress to moving arm with good scapular control with mirror. Afterward, participants will undergo movements protocol which give different directions of arm movements while keeping scapula in a good alignment. They will also receive scapular-focused exercises. The difficulty of the movement protocol will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
16404849|NCT04493190|Procedure|General exercise|Participants in this group will receive a general shoulder strengthening with theraband or dumbbell. Load will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
16404850|NCT04484077|Biological|hCT-MSC|2x10^6 hCT-MSC/kg suspended in plasmalyte-A, 5% HSA, and residual DMSO/dextran administered intravenously over 30-60 minutes via syringe pump
16404851|NCT04479488|Other|Hospital admission|Usual care.
16404852|NCT04479488|Other|Non-hospitalization procedures|Usual care.
16404853|NCT04475432|Drug|TP-03, 0.25%|TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
16404854|NCT04475432|Drug|TP-03 Vehicle|Vehicle of TP-03 ophthalmic solution, administered twice a day
16404855|NCT04466410|Biological|XT-150|Single bolus intrathecal injection
16404856|NCT04466410|Biological|Placebo|Placebo
16404857|NCT04457440|Behavioral|Intensive Lifestyle Intervention|This intervention is an abbreviated version of the Diabetes Prevention Program, which has been shown to be effective in reducing the risk of developing type 2 diabetes.
16404937|NCT04287660|Drug|clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells|"clarithromycin: 500mg, PO, twice daily, on days 1~21 for a 28-day cycle.
~lenalidomide: 25mg, PO, on days 1~21 for a 28-day cycle. dexamethasone: 40mg, PO on days 1,8,15 and 22 for a 28-day cycle. BCMA CAR T cell: (2-3)×10E7/kg, intravenously infusion.
~Doses should be adjusted according to renal function."
16404858|NCT04457440|Behavioral|Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention|This intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. The additional sleep components will include (a) psychoeducation about the importance of sleep in weight control and glycemic control, (b) sleep hygiene, (c) stimulus control, (d) modifying maladaptive beliefs about sleep, (e) and, setting individualized sleep schedule and reviewing sleep schedule.
16404859|NCT04454671|Other|Ultrasound-guided percutaneous neuromodulation (NMPE)|It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve
16404860|NCT04454671|Other|Ultrasound-guided dry needling|Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results.
16404861|NCT04450407|Drug|LY3209590|Administered SC
16404862|NCT04450407|Drug|Insulin Degludec|Administered SC
16404863|NCT04448834|Drug|Blinatumomab|liposomal vincristine 2.25 mg/m2 weekly x 3 per cycle (weeks 3-5 in cycle 1 and 2-4 in subsequent cycles)
16404864|NCT04447651|Other|Recommendation for treatment with immunotherapy|Patients with a SF3B1, U2AF1 or SRSF2 mutation will be reviewed by the molecular tumor board and treatment recommendations will be given to the patient's treating oncologist.
16404868|NCT04435834|Diagnostic Test|Magnetic Resonance Imaging|Magnetic Resonance Imaging (MRI) images will be collected. Clinical imaging will be performed as per clinical standard-of care. Additional MRI images will measure cerebral blood flow and cerebral metabolism.
16404869|NCT04434807|Procedure|Minimally invasive hematoma evacuation|Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
16404870|NCT04428411|Drug|Enbrel|As provided in real world practice
16404871|NCT04423718|Drug|Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)|Solution in Vial, intravitreal (IVT) injection
16404872|NCT04423718|Drug|Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)|Solution in Vial, 2 mg, intravitreal (IVT) injection
16404873|NCT04415541|Behavioral|Psychodynamic Psychotherapy|Intensive psychotherapy that is psychodynamically oriented.
16404874|NCT04415541|Behavioral|Usual Care|Conventional treatment offered in the community.
16404875|NCT04415151|Drug|Tofacitinib 10 mg|Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.
16404876|NCT04415151|Drug|Placebo|Matching placebo tablets will be administered.
16404877|NCT04409080|Drug|REGN7257|Single dose will be administered by intravenous IV infusion
16404879|NCT04405479|Behavioral|Examination of tremor and upper hand functions|Participants will be only examined. They will not undergo any intervention.
16404880|NCT04404400|Drug|Investigational products administration|"Investigational products include:
~Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and
~9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.
~All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off."
16404881|NCT04404400|Drug|Placebo administration|Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.
16404882|NCT04401800|Drug|Lenvatinib|Capsules administered orally once daily
16404883|NCT04401800|Drug|Tislelizumab|200 mg intravenous (IV) infusion administered on Day 1 of each cycle
16404884|NCT04399889|Biological|Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.|Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
16404885|NCT04399889|Other|Placebo|Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
16404896|NCT04393337|Other|Gestational Age Chart Method|The endotracheal tube insertion depth is obtained by the gestational age chart
16404897|NCT04393337|Other|Nasal-Tragus Length Method|The endotracheal tube insertion depth is obtained by the nasal-tragus method formula
16404898|NCT04378439|Behavioral|Peer Navigation|"First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services.
~Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention"
16405106|NCT03974750|Device|Bimanual motor skill learning with the REAplan(R) rehabilitation robot|REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements
16404899|NCT04378439|Behavioral|mHealth|"In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate in-real-time via social media about the process of participating in a syringe services program or accessing PrEP."
16404901|NCT04373330|Behavioral|Intensive Lifestyle Intervention|There will be 14 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, participant workbooks, and the DVD series. These materials will be adapted for use in HELP-VM and will include information on migraine and its management as well as mental health resources available to Veterans for common illnesses like depression and post-traumatic stress disorder and modifying physical activity recommendations for Veterans with limited mobility.
16404907|NCT04366791|Radiation|Low Dose Radiation Therapy|Undergo low-dose radiation therapy
16404908|NCT04356989|Drug|Rivaroxaban (Xarelto, BAY59-7939)|The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.
16404909|NCT04356963|Behavioral|Virtual Reality Session|20-30 minute session of virtual reality immersive content.
16404910|NCT04356963|Behavioral|Tablet-based Session|20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.
16404911|NCT04356963|Behavioral|Use of Virtual Reality Head Mounted Display without Content|20-30 minutes session using head mounted display to reduce light and sound.
16404912|NCT04350073|Device|Q-NRG Metobolic Cart Device|COVID-19 ICU patients will be measured using the Q-NRG device for up to 30 mins. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.
16404913|NCT04350073|Device|MuscleSound Ultrasound|COVID-19 ICU patients will have muscle mass, muscle glycogen, and muscle quality measured at rectus femoris (leg), intercostal, and temporal muscle. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.
16404914|NCT04350073|Device|Multifrequency Bioimpedance Spectroscopy|COVID-19 ICU patients will have body composition and phase angle measured using Multifrequency Bioimpedance Spectroscopy. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.
16404915|NCT04341467|Drug|Amisulpride|The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
16404916|NCT04341467|Drug|Olanzapine|The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
16404918|NCT04333706|Drug|Capecitabine|Capecitabine 1000 mg BID
16404919|NCT04333706|Combination Product|Sarilumab 150mg or 200 mg plus Capecitabine|Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
16404920|NCT04333706|Combination Product|Sarilumab 150mg plus Capecitabine|Dose escalation schedule of sarilumab. The starting dose for sarilumab is 150 mg SQ every 21 days, given 3 days prior to the first 4 of 8 cycles of capecitabine 1000 mg BID.
16404921|NCT04322513|Diagnostic Test|Biomarkers expression|Evaluation in biomarkers expression between 2 groups
16404922|NCT04321915|Other|Analysis of intestinal microbiota in autism spectrum desorder|This analysis permit to describe the diversity and composition of microbiota and the factors that may influence them. In fact, the gut microbiota plays a key role in regulating the gut-brain axis
16404923|NCT04321915|Other|Analysis of neuroinflammation markers in autism spectrum desorder|This analysis permit to reveal the integrity of the blood-brain barrier (BBB) which is affected in autism spectrum desorder.
16404925|NCT04319718|Combination Product|MK-2048 High Eudragit Vaginal Film|"2 x 2 vaginal film containing 30 mg of MK-2048 and either 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)"
16404926|NCT04319718|Combination Product|MK-2048 Low Eudragit Vaginal Film|"2 x 2 vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)"
16404930|NCT04310137|Behavioral|Therapist-Directed Re-loading|Therapist will specifically direct participant to increase walking by 10% as measured at each of the activity monitoring assessments. In addition, the participant will be asked to monitor foot temperature to mitigate risk for breakdown.
16404931|NCT04309305|Device|EksoGT™, Ekso Bionics, Berkley, CA, USA|The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking.
16404932|NCT04309305|Other|Standard of Care|Standard gait therapy provided by licensed physical therapists post stroke.
16404933|NCT04309305|Other|No Intervention|Testing Only
16404934|NCT04308304|Drug|MK-1942|MK-1942, oral, 1-mg, 5-mg and/or 10-mg capsules, BID dosing up to 28 days
16404935|NCT04308304|Drug|Donepezil|Donepezil, oral, 5-mg and/or 10-mg tablet (maximum dose 15 mg QD), QD dosing for up to 28 days
16404936|NCT04308304|Drug|Placebo|Placebo to MK-1942, oral, capsule, all dosage levels, BID dosing for up to 28 days.
16404939|NCT04280016|Behavioral|Exercise|Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading.
16404940|NCT04278417|Biological|Brolucizumab 6 mg|3 x q6w loading injections, followed by q12w maintenance through Week 90
16404941|NCT04278417|Procedure|Panretinal photocoagulation laser|initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
16404942|NCT04274465|Diagnostic Test|digital PCR (dPCR) assay|It is a highly sensitive and specific droplet digital PCR assay for absolute quantification of circulating tumor HPV DNA for the most prevalent HPV types that will determine if a woman has cHPVDNA
16404958|NCT04264819|Drug|RTH258/Brolucizumab|Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by Treat-to-Control regimen up to Week 44/46.
16404959|NCT04262791|Device|Wrist Actigraphy Device|Wrist Actigraphy Device
16404960|NCT04262791|Device|Sleep Headband|Sleep Headband
16404961|NCT04259320|Device|Beeswax containing barrier|Use beeswax containing barrier on each nipple after each breastfeeding.
16404962|NCT04259320|Biological|Breast milk|Apply breast milk on each nipple and areola after each breastfeeding.
16404965|NCT04255277|Drug|Combined oral contraceptives (COC)|A commercially available COC consisting of 0.1mg levonorgestrel and 0.02 mg ethinylestradiol will be used and administered open-label.
16404966|NCT04255277|Drug|Moxifloxacin 400mg|A commercially available formulation of moxifloxacin 400 mg will be used and administered open-label. All tablets will be from the same batch.
16404967|NCT04255277|Drug|Cenerimod 0.5 mg|This will be administered orally as a film-coated tablet in the morning.
16404968|NCT04255277|Drug|Cenerimod 4 mg|This will be administered orally as a film-coated tablet in the morning.
16404969|NCT04255277|Other|Charcoal, activated|Granules for oral suspension will be used and administered open-label.
16404970|NCT04255277|Drug|Matching Placebo|Cenerimod matching placebo tablets will be administered once daily orally in the morning.
16404971|NCT04250233|Device|Respiratory Monitor|All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.
16404972|NCT04238520|Behavioral|Functionally Tailored Oral Care Intervention|Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
16404973|NCT04238520|Behavioral|Control Intervention|Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.
16404974|NCT04238481|Drug|ASP5354|Intravenous
16404975|NCT04236414|Drug|Olaparib|"Patients will receive a single dose of olaparib on Day 1, followed by initiation of bd continuous dosing from Day 2 onwards. Olaparib tablets should be taken at the same time each day (morning and evening), approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food, with the exception of Day 8 (a PK sampling day) when patients aged ≥3 years old receiving tablets should take olaparib at least 1 hour after food and should refrain from eating for up to 2 hours afterwards.
~25 and 100 mg tablet strengths available for ages ≥3 to <18 years. Feasibility for an AAF for ≥0.5 to <6 years planned."
16404976|NCT04218539|Drug|Psilocybin|10mg Psilocybin
16404977|NCT04218539|Drug|Placebo|25mg Diphenhydramine
16404978|NCT04217577|Dietary Supplement|Dried plums|10-16 dried plums/day, approximately 100-120 g/day
16405068|NCT04071613|Drug|Intravenous tissue plasminogen activator (tPA)|Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset
16405069|NCT04069104|Behavioral|ABCD Information|The intervention condition includes exposure to a message emphasizing the ABCD strategy to identify malignant melanoma.
16404988|NCT04208906|Device|Masimo O3|"After anesthesia induction, a masimo O3 sensors are attached to the forehead (ScO2) and the sole of the foot (StO2). About 0.4 ml blood samples are obtained from arterial line and central venous line at three epochs before and after cardiopulmonary bypass (total 6 times)
~T1: before cardiopulmonary bypass (CPB), fraction of inspired oxygen (FiO2) 0.2
~T2: before CPB, FiO2 0.5
~T3: before CPB, FiO2 0.8
~T4: after CPB, FiO2 0.8
~T5: after CPB, FiO2 0.5
~T6: after CPB, FiO2 0.2
~Hemoglobin oxygen saturation values are confirmed in each sample (arterial sample: SaO2, venous sample: SvO2). Each O3 values (ScO2 and StO2) are compared to the values of SvO2, 0.7 × SvO2 + 0.3 × SaO2."
16404989|NCT04207346|Device|TMS 1 hz|High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the active side.
16404990|NCT04207346|Device|Sham TMS|High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the sham side.
16404992|NCT04194671|Biological|Mesenchymal stem cells|In experimental group, patients receive standard treatment and allogeneic human umbilical cord derived-mesenchymal stem cells (MSCs) is administered via intravenous infusion on day 0 and day 7
16404993|NCT04194671|Other|Saline|In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7
16404994|NCT04184635|Device|VA-ECMO|"The ECMO device will be the CardioHelp (MAQUET, GETINGE, Orléans, France) using the veno-arterial setting and percutaneous femoro-femoral cannulation with MAQUET GETINGE HLS cannulae.
~Intraortic balloon pump will be MEGA 50 cc or 40cc, (MAQUET, GETINGE, Orléans, France)."
16404995|NCT04181060|Biological|Bevacizumab|Given IV
16404996|NCT04181060|Drug|Osimertinib|Given PO
16404997|NCT04174859|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Treatment dose is following the description of physicians.
16404998|NCT04173169|Drug|Elagolix 200 MG|Elagolix tablet
16404999|NCT04173169|Drug|Placebo|Sugar pill manufactured to mimic Elagolix 200mg
16405002|NCT04160468|Drug|Exebacase|Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.
16405003|NCT04160468|Drug|Placebo|Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
16405004|NCT04158258|Drug|Bevacizumab|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405005|NCT04158258|Drug|Trastuzumab|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405006|NCT04158258|Drug|Ado-trastuzumab emtamsine|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405007|NCT04158258|Drug|Pertuzumab|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405008|NCT04158258|Drug|Atezolizumab|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405009|NCT04158258|Drug|Capecitabine|Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.
16405010|NCT04154189|Drug|Lenvatinib|"Lenvatinib 14 milligrams per square meter (mg/m^2) capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor.
~An extemporaneous suspension of lenvatinib capsules may be used for participants unable to swallow capsules."
16405011|NCT04154189|Drug|Ifosfamide|Ifosfamide 3000 milligrams per square meter per day (mg/m^2/day) intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.
16405012|NCT04154189|Drug|Etoposide|Etoposide 100 mg/m^2/day intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.
16405013|NCT04154189|Drug|Lenvatinib|Lenvatinib 14 mg/m^2 capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until the next PD (per response evaluation criteria in solid tumors [RECIST] 1.1 as assessed by investigator), development of unacceptable toxicity, participant request, or withdrawal of consent, whichever occurs first.
16405014|NCT04149587|Drug|Brodalumab|Brodalumab will be administered per dose and schedule specified in the arm.
16405017|NCT04142385|Other|Cytology Specimen Collection Procedure|Undergo blood, urethral swab, penile skin cell, and anal swab collection
16405018|NCT04142385|Other|Laboratory Biomarker Analysis|Correlative studies
16405019|NCT04142385|Procedure|Medical Examination|Undergo anal and penile clinical exam
16405020|NCT04142385|Procedure|Physical Examination|Undergo targeted physical exam
16405021|NCT04142385|Procedure|Proctoscopy with Biopsy|Undergo HRA
16405022|NCT04142385|Other|Questionnaire Administration|Ancillary studies
16405070|NCT04069104|Behavioral|UDS information|The intervention condition includes exposure to a message emphasizing the UDS strategy to identify malignant melanoma.
16405071|NCT04069104|Behavioral|Standard (clinical) feedback|Feedback on mole identification task provided by a dermatologist.
16405272|NCT03659136|Drug|Exemestane|Tablet
16405023|NCT04142034|Behavioral|the iAmHealthy Behavioral Intervention|"iAmHealthy Behavioral Intervention Arm
~Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:
~usual care at their clinic for all issues, including overweight and obesity;
~a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);
~weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;
~11 hours of individual homework sessions with the iAmHealthy behavioral intervention dietician"
16405024|NCT04142034|Behavioral|Newsletter only arm|Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
16405025|NCT04142034|Other|Consecutive Recruitment|Recruitment of study participants through identifying potential participants through their medical records
16405026|NCT04142034|Other|Traditional Recruitment|Recruitment of potential participants through flyers and advertisements
16405027|NCT04139317|Drug|Capmatinib|Oral tablet
16405028|NCT04139317|Biological|Pembrolizumab|IV infusion
16405029|NCT04137458|Biological|Biological analysis|Blood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out
16405030|NCT04124042|Biological|XT-150|plasmid DNA
16405031|NCT04122261|Device|the MicroHand S endoscopic instrument control system|Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
16405032|NCT04122261|Device|the da Vinci endoscopic instrument control system|Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
16405033|NCT04113759|Behavioral|Blood Flow Restriction Rehabilitative Therapy|"BFR cuffs placed at the proximal thigh, just inferior to the greater trochanter.
~Inflation time not to exceed 20 minutes. One BFR session per treatment. BFR exercise dosage: 4 sets of the following repetitions 30, 15, 15, 15, 30 second rest between sets, 1 min rest between exercises.
~Progress exercise if pain <2/10 on VAS and RPE <5 on 0-10 scale. (Heerey et al), and no break down in form."
16405034|NCT04113759|Behavioral|Sham BFR Rehabilitative Therapy|The schedule, type of exercises, repetition ranges, and other physical therapy interventions will be the same as the BFR experimental group - however a non-occlusive pressure will be applied with the cuff in the control group.
16405035|NCT04112381|Device|Exablate Model 4000 Type 1.0/1.1|Exablate thalamotomy of non tremor dominant side of the brain
16405036|NCT04110249|Procedure|Photoacoustic Imaging|Undergo PAI
16405037|NCT04110249|Procedure|Transcutaneous Acupoint Electrical Stimulation|Undergo ALTENS
16405038|NCT04108858|Drug|Copanlisib|Given IV
16405039|NCT04108858|Biological|Pertuzumab|Given IV
16405040|NCT04108858|Biological|Trastuzumab|Given IV
16405041|NCT04106583|Device|WAVE, as part of the SMART COIL System|WAVE, as part of the SMART COIL System
16405042|NCT04106089|Behavioral|Extended time between vitals check|Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
16405043|NCT04102189|Drug|Semaglutide|Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
16405044|NCT04102189|Drug|Placebo|Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
16405045|NCT04096807|Other|Standard TEE exam including measurement of left upper pulmonary vein diameter and collapsibility, compared with PCWP measured continuously by a pulmonary arterial catheter|TEE takes part of the standard perioperative hemodynamic monitoring in cardiac surgery. Patients enrolled in the study are also monitored by a pulmonary arterial catheter
16405046|NCT04096716|Drug|Tc-99m tilmanocept|Tc-99m tilmanocept is a radioactive diagnostic agent.
16405047|NCT04092270|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16405048|NCT04092270|Drug|Peposertib|Given PO
16405053|NCT04087018|Drug|zimberelimab|zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.
16405058|NCT04086147|Drug|Low dose tenecteplase|Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
16405059|NCT04086147|Drug|High dose tenecteplase|Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)
16405060|NCT04086030|Other|Blood Flow Restriction Training|Patients will undergo standardized postoperative rehabilitation program including blood flow restriction training. Exercises will be performed with BFR at 80% LOP.
16405061|NCT04086030|Other|Sham Blood Flow Restriction Training|Patients will undergo standardized postoperative rehabilitation program where exercises will be performed with sham BFR pressure of 20 mmHG.
16405062|NCT04082481|Drug|TAK-988|TAK-988 tablets.
16405063|NCT04082481|Drug|TAK-988 Placebo|TAK-988 placebo-matching tablets.
16405064|NCT04075864|Behavioral|Behavioral Counseling and Exercise|exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation
16405067|NCT04071613|Drug|Tenecteplase|Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
16405072|NCT04069104|Behavioral|Motivational feedback|Feedback on mole identification task provided by a dermatologist plus exposure to a motivational fear appeal message designed to increase skin self exam intentions.
16405073|NCT04060680|Device|Defibrillation using the Extravascular ICD|VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
16405074|NCT04058158|Drug|SB12 (proposed eculizumab biosimilar)|600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
16405075|NCT04058158|Drug|Soliris (eculizumab)|600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
16405079|NCT04051229|Behavioral|6-week exercise training program|Participants will walk at 50% Heart Rate Reserve (HRR) 3 to 5 days per week for 6 weeks at the Department of Health and Exercise Science Clinical Research Center under the supervision of study staff.
16405080|NCT04051229|Behavioral|Standardized isoenergetic high fat diet|Prior to the submaximal exercise testing visits, all participants will be provided with 3 days of a standardized isoenergetic high fat diet (20% of kcals from carbohydrate, 65% fat; 15% protein) to promote lipid oxidation. The meals will be prepared and provided by the Clinical Research Unit of Wake Forest Baptist Health. Participants will pick up 3 days' worth of food and snacks 4 days prior the testing visit. For the 3 days leading up to the visit, participants will eat the provided foods and complete a compliance assessment.
16405081|NCT04049383|Biological|CAR-20/19-T cells|"The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Patients will receive one of four dose levels of CAR-20/19-T cells based on our dose escalation design (Section 6). Cell dose will be maxed at 80 kg.
~Dose Level -1: 1 x 10*5 CAR-20/19-T cells/kg Dose Level 0: 2.5 x10*5 CAR-20/19-T cells/kg (starting dose level) Dose Level 1: 7.5 x10*5 CAR-20/19-T cells/kg Dose Level 2: 2.5 x10*6 CAR-20/19-T cells/kg (goal cell dose)"
16405082|NCT04025710|Device|BIOMONITOR III and BIOMONITOR IIIm|"Insertion of BIOMONITOR III or BIOMONITOR IIIm
~three scheduled in-office follow-ups
~48-hour Holter ECG"
16405083|NCT04018677|Device|TOGETHER|TOGETHER is a mobile application software by Medable Inc.
16405084|NCT04017832|Drug|Oral semaglutide|Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
16405085|NCT04017832|Drug|Sitagliptin|Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
16405086|NCT04017832|Drug|Placebo (oral semaglutide)|Placebo tablet to be taken first thing in the morning
16405087|NCT04017832|Drug|Placebo (sitagliptin)|Placebo tablet to be taken 30 minutes after oral semaglutide
16405088|NCT04012177|Dietary Supplement|Balanced-energy protein (BEP)|Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
16405089|NCT04012177|Drug|Azithromycin Tablets|Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.
16405090|NCT04012177|Drug|Choline Bitartrate|Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome
16405091|NCT04012177|Drug|Nicotinamide|Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome
16405092|NCT04010461|Device|TMS|Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
16405093|NCT04010461|Behavioral|n-back working memory task|Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (2 letters or 1 letter)
16405094|NCT04006223|Diagnostic Test|11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment|10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
16405095|NCT04006223|Diagnostic Test|11C-PIB or 18F-florbetapir PET/MR after treatment|10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
16405096|NCT04005352|Biological|Brolucizumab 6 mg|3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.
16405097|NCT04005352|Biological|Aflibercept 2 mg|3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62
16405098|NCT03988621|Behavioral|ViCCY|Virtual Health Coaching for You
16405099|NCT03985501|Other|SCD newborn screening with the MS/MS method from Zentech|The analysis of the SCD newborn screening with the MS/MS method from Zentech will be realized after achievement and biological validation of the SCD newborn screening in the usual care pathway. The results will be compared with the method used at the Lille Academic Hospital (CHU Lille) (sub-contractor for SCD newborn screening of Lyon)
16405100|NCT03984812|Drug|GSK3732394|It is composed of an anti-CD4 adnectin, an anti-N17 adnectin, and a peptide inhibitor. This will be provided as a solution for injection in 1 (milliliter) mL glass vials with the unit dose strength of 100 mg/mL
16405101|NCT03984812|Drug|Placebo|Placebo will comprise of 0.9% weight per volume (w/v) sodium chloride.
16405102|NCT03979742|Biological|Umbilical Cord Blood Mononuclear Cell|Active ingredients: Monocytes, CD34+, CD133+ cells Dose: 4 injections of 16-μliter (100,000 cells/μliter)
16405103|NCT03979742|Drug|Lithium Carbonate|Active Ingredients: Lithium Dose: 900-1200 mg/day in 300 mg tid or 600 mg bid
16405104|NCT03979742|Other|Placebo|Placebo
16405105|NCT03979742|Other|Locomotor Training|Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months
16405193|NCT03849443|Drug|Vitamin C 250 MG Oral Tablet|Oral method of placebo
16405107|NCT03966807|Behavioral|Digital-based support|Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options.
16405108|NCT03966807|Behavioral|Traditional-based support + Nicotine replacement therapy (NRT)|Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources.
16405109|NCT03954132|Drug|Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist|LAMA+LABA
16405110|NCT03954132|Drug|Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids|(LAMA+LABA+ Inhalative Corticosteroids (ICS)
16405111|NCT03949283|Diagnostic Test|ChemoID Assay|"The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill bulk of tumor cells, and cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs.
~The test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse."
16405112|NCT03949283|Drug|Standard Chemotherapy|"Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations:
~Liposomal Doxorubicin; Docetaxel; Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Topotecan; Carboplatin, Gemcitabine; Cisplatin, Gemcitabine; Carboplatin, Liposomal Doxorubicin; Carboplatin, Paclitaxel; Carboplatin, Docetaxel. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab."
16405113|NCT03948763|Biological|V941|V941 administered IM, Q3W for 9 3-week cycles
16405114|NCT03948763|Biological|Pembrolizumab|Pembrolizumab 200 mg, IV for 35 3-week cycles
16405115|NCT03943849|Other|Particulate bone graft|Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
16405116|NCT03943849|Other|Autogenous dental pulp tissue|Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket.
16405117|NCT03943849|Other|Resorbable collagen membrane|After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.
16405118|NCT03943849|Other|Suture|Resorbable or non-resorbable suture material
16405119|NCT03936829|Drug|Cyclophosphamide|Admitted to the hospital every 4 weeks. Cyclophosphamide was intravenously instilled (500mg mg/m2 of BSA) after contraindications are excluded. ECG monitoring will be taken during the medication. A total of 6 treatments will be performed.
16405120|NCT03932682|Biological|QIVc|QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
16405121|NCT03932682|Biological|Comparator|Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)
16405122|NCT03927690|Drug|LKA651|LKA651 IVT
16405123|NCT03927690|Drug|LKA651|LKA651 IVT
16405124|NCT03927690|Drug|Lucentis|Lucentis IVT
16405125|NCT03927690|Drug|Lucentis|Lucentis IVT
16405126|NCT03924986|Drug|Tislelizumab|200 mg administered intravenously (IV)
16405127|NCT03924986|Drug|Placebo|Placebo to match Tislelizumab
16405128|NCT03924986|Drug|Gemcitabin|1 g/m2, administered as an IV infusion within 30 minutes
16405129|NCT03924986|Drug|Cisplatin|80 mg/m2, administered as an IV infusion over 4 hours
16405130|NCT03922620|Drug|Liposomal bupivacaine|Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
16405131|NCT03922620|Drug|Peripheral Nerve Block|Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
16405140|NCT03914300|Drug|Cabozantinib S-malate|Given PO
16405141|NCT03914300|Biological|Ipilimumab|Given IV
16405142|NCT03914300|Biological|Nivolumab|Given IV
16405143|NCT03909893|Radiation|Adaptive Radiation Therapy|Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.
16405144|NCT03909165|Drug|Sugammadex 2 mg/kg|For moderate NMB reversal, a single IV bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.
16405145|NCT03909165|Drug|Sugammadex 4 mg/kg|For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
16405194|NCT03849443|Drug|Tranexamic Acid 650Mg Tablet|Oral method of treatment group
16405195|NCT03841110|Drug|FT500|FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
16405146|NCT03909165|Drug|Neostigmine + Glycopyrrolate|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
16405147|NCT03909165|Drug|Neostigmine + Atropine|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.
16405148|NCT03909139|Biological|BMAC|A bone marrow biopsy needle will be inserted through an arthroscopy portal and directed to the acetabuloplasty site. Bone marrow is aspirated then centrifuged. From the centrifuged sample, the buffy coat layer (layer of cells, found between the red blood cells and the plasma layers) is removed. The buffy coat layer contains mesenchymal stromal cells. This is called BMAC or Bone Marrow Aspirate Concentrate. The BMAC will be injected into the intra-articular space.
16405149|NCT03907969|Drug|AZD7648|Core: AZD7648 will be administered orally
16405150|NCT03907969|Drug|PLD|The starting dose of PLD is 40 mg/m^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles
16405161|NCT03905434|Genetic|miRNA sampling|Blood samples for miRNA testing will be collected from all subjects (control and patients diagnosed with acute ischemic stroke)
16405162|NCT03904043|Radiation|Radiation therapy|-Monday-Friday treatment is strongly recommended
16405163|NCT03904043|Drug|FOLFOX regimen|-CAPOX can be given as alternative
16405164|NCT03904043|Other|Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire|-Baseline, completion of chemotherapy (3-8 weeks after the end of chemotherapy), and 10 to 14 months after radiotherapy
16405165|NCT03904043|Procedure|Rectal biopsy samples|-Multiple biopsy samples of the rectal tumor will be taken from the patient tumor prior to treatment initiation for genomic extraction. For patients at affiliate sites who do not have enough tissue from the diagnostic biopsy, a repeat pre-treatment biopsy is optional.
16405166|NCT03904043|Procedure|Blood for ctDNA|-Prior to the start of treatment, Post radiation therapy labs (with standard of care (SOC) CBC/CMP prior to start of cycle 1 of chemotherapy), Day 1 of cycle 2 of chemotherapy (with SOC CBC/CMP), Completion of chemotherapy (3-8 weeks after the end of chemotherapy), months 3, 6, 9, 12, 16, 20, 24 until salvage surgery or 2 years from completion of chemotherapy (whichever is first)
16405167|NCT03901573|Drug|NT-I7|"Dose Escalation (Phase 1b) - NT-I7 IM (intramuscular) on Day 1 of each Cycle until MTD or RP2D is achieved.
~Dose Expansion - NT-I7 IM (intramuscular) on Day 1 of each Cycle, at Maximum Tolerated Dose (MTD) or RP2D defined in escalation phase"
16405168|NCT03901573|Drug|atezolizumab|"Dose Escalation - atezolizumab IV (intravenous) on Day 1 of each Cycle
~Dose Expansion - atezolizumab IV (intravenous) on Day 1 of each Cycle"
16405174|NCT03889093|Other|Yttrium-90|This is to evaluate the immunologic effects of yttrium 90.
16405175|NCT03887780|Drug|Rivaroxaban (Xarelto,Bay 59-7939)|15 mg and 20 mg (OD)
16405176|NCT03879044|Device|Transcranial Direct Current Stimulation|tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.
16405177|NCT03876054|Device|Spinal cord stimulation (SCS)|Subjects will be implanted with market-released Abbott SCS systems
16405178|NCT03876054|Device|Dorsal root ganglion stimulation (DRG)|Subjects will be implanted with market-released Abbott DRG system
16405187|NCT03853187|Radiation|Zr-89 labelled durvalumab PET/CT|Patients will undergo a Zr-89 labelled durvalumab (MEDI4736) PET/CT and dedicated perfusion-CT prior to treatment with durvalumab (MEDI4736) and in- and ex-vivo In-111-oxine labelled CD8+ T-cells after two courses of treatment, prior to surgery.
16405188|NCT03853187|Drug|Durvalumab (MEDI4736)|Patients will receive two courses of durvalumab (MEDI4736)at a fixed dose of 750mg Q2W intravenously, prior to scheduled resection of NSCLC.
16405189|NCT03852719|Drug|Bulevirtide|Administered via subcutaneous injections
16405190|NCT03851237|Drug|64Cu-DOTA-ECLIi|-The first four patients enrolled on study will undergo an additional delayed imaging time point approximately 2-6 hours following 64Cu-DOTA-ECL1i
16405191|NCT03851237|Device|PET/CT|-Standard of care
16405192|NCT03849443|Drug|Tranexamic Acid Injectable Product (1000 mg intravenous bolus)|Intravenous methods to decrease blood loss
16405214|NCT03797261|Drug|Venetoclax|tablet, oral
16405215|NCT03797261|Drug|AMG 176|solution, intravenous
16405226|NCT03783403|Drug|CC-95251|CC-95251 administered by IV (intravenous) infusion.
16405227|NCT03783403|Drug|Rituximab|Rituximab administered by IV (intravenous) infusion.
16405228|NCT03783403|Drug|Cetuximab|Cetuximab administered by IV (intravenous) infusion.
16405229|NCT03774082|Drug|INC424|Ruxolitinib is taken orally either as 5mg tablets or as pediatric formulation (dosage based on age group)
16405230|NCT03765736|Other|Genetic Testing|Undergo genetic testing
16405231|NCT03739840|Drug|Padsevonil|Padsevonil in different dosages.
16405232|NCT03739840|Drug|Placebo|Placebo will be provided matching padsevonil.
16405239|NCT03730987|Behavioral|HoMBReS intervention|The experimental group (group A) will receive an intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors among recently migrated rural men.
16405240|NCT03730987|Behavioral|Families Talking Together (FTT)|The brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, and prepare them to teach adolescents assertiveness and substance abuse refusal skills.
16405241|NCT03730987|Behavioral|Diabetes Prevention Intervention|Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.
16405242|NCT03713294|Drug|Dexamethasone|Given intravenously (IV) and orally (PO)
16405243|NCT03713294|Biological|Elotuzumab|Given intravenously (IV)
16405244|NCT03713294|Drug|Pomalidomide|Given orally (PO)
16405245|NCT03706963|Other|Phone Call|-phone call 7 days (+/- 2 days) into preoperative period
16405246|NCT03704350|Dietary Supplement|controlled diet|Participants will consume a diet that is controlled in its daily contents of oxalate, calcium, vitamin C and sodium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements (vitamins, calcium or other minerals, herbal supplements, nutritional aids), to exercise strenuously, or to consume food or drink that is not provided to them as part of the controlled diet.
16405247|NCT03701399|Drug|troriluzole|200 mg PO
16405248|NCT03701399|Drug|Placebos|200 mg PO
16405251|NCT03695367|Drug|HTX-011|HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
16405252|NCT03695367|Device|Luer lock applicator|Applicator for instillation.
16405253|NCT03695367|Device|Vial access device|Device for withdrawal of drug product.
16405254|NCT03695367|Drug|Ibuprofen|Ibuprofen, 600 mg.
16405255|NCT03695367|Drug|Acetaminophen|Acetaminophen, 1 g.
16405256|NCT03695367|Drug|Ketorolac|Intraoperative IV ketorolac.
16405257|NCT03687528|Radiation|CT-scanner|After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.
16405258|NCT03674567|Drug|FLX475|tablet
16405259|NCT03674567|Drug|Pembrolizumab|IV infusion
16405260|NCT03670355|Drug|Tenofovir (TFV) IVR|Contains 1.4 g TFV
16405261|NCT03670355|Drug|Placebo IVR|Contains placebo
16405262|NCT03663205|Drug|Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed|Treatment for advanced NSCLC
16405263|NCT03663205|Drug|Cisplatin or Carboplatin,Pemetrexed|Treatment for advanced NSCLC
16405269|NCT03659136|Drug|Xentuzumab|Intravenous infusion
16405270|NCT03659136|Drug|Placebo|Intravenous infusion
16405271|NCT03659136|Drug|Everolimus|Tablet
16405273|NCT03649932|Dietary Supplement|Enteral L-citrulline|"L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.
~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.
~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."
16405274|NCT03647488|Drug|Capmatinib|Capmatinib 400 mg (tablets) orally taken twice daily
16405275|NCT03647488|Drug|Spartalizumab|Spartalizumab 400 mg via intravenous infusion once every 28 days
16405276|NCT03647488|Drug|Docetaxel|Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
16405277|NCT03636061|Drug|OC-01 (varenicline) nasal spray|OC-01 (varenicline) nasal spray
16405278|NCT03636061|Drug|Placebo (vehicle) nasal spray|Placebo
16405279|NCT03632798|Diagnostic Test|ChemoID assay|"The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill not only bulk of tumor cells, but importantly the cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs.
~The test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse."
16405280|NCT03632798|Drug|Chemotherapy|"Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer.
~Chemotherapy list:
~Liposomal Doxorubicin;
~Docetaxel;
~Paclitaxel;
~Carboplatin;
~Cisplatin;
~Gemcitabine;
~Topotecan;
~Carboplatin, Gemcitabine;
~Cisplatin, Gemcitabine;
~Carboplatin, Liposomal Doxorubicin;
~Carboplatin, Paclitaxel;
~Carboplatin, Docetaxel."
16405281|NCT03628677|Drug|Domvanalimab|Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT
16405282|NCT03628677|Drug|Zimberelimab|Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1
16405283|NCT03621696|Drug|Cisplatin|-100 mg/m^2 intravenous push bolus (IVPB)
16405284|NCT03621696|Radiation|Intensity modulated radiation therapy|-IMRT or IMPT can be used
16405285|NCT03621696|Radiation|Intensity modulated proton therapy|-IMRT or IMPT can be used
16405286|NCT03621696|Procedure|Surgery|-Standard of care
16405287|NCT03621696|Other|FACT-H&N|-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
16405288|NCT03621696|Other|MD Anderson Dysphagia Inventory|-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
16405289|NCT03621696|Other|University of Michigan Xerostomia Index|-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
16405290|NCT03621696|Other|Scale of Subjective Total Taste Acuity|-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
16405291|NCT03621696|Other|Neck Dissection Impairment Index|-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
16405292|NCT03610516|Drug|CFZ533|multiple doses of CFZ533 intravenous infusion
16405293|NCT03610516|Drug|Placebo|multiple doses of placebo intravenous infusion
16405294|NCT03609697|Behavioral|group-based lifestyle intervention|Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.
16405295|NCT03609697|Behavioral|Minimal intervention (SMS intervention)|Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.
16405306|NCT03597581|Drug|RGX-202-01|RGX-202-01 is a small molecule inhibitor of the creatine transporter, SLC6a8.
16405307|NCT03597581|Drug|FOLFIRI|FOLFIRI is a chemotherapy regimen consisting of irinotecan, leucovorin, and 5-fluorouracil. Irinotecan is a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.
16405308|NCT03597581|Drug|Bevacizumab|Bevacizumab is a vascular endothelial growth factor inhibitor.
16405309|NCT03597399|Biological|AAV2-hRPE65v2,voretigene neparvovec-rzyl|Subretinal administration of gene therapy vector AAV2-hRPE65v2 (voretigene neparvovec-rzyl) to both eyes via surgical procedures on separate days.
16405310|NCT03595124|Drug|Axitinib|Given PO
16405311|NCT03595124|Biological|Nivolumab|Given IV
16405312|NCT03593915|Combination Product|Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine|"PHASE 1b:
~Decitabine administered as an intravenous (IV) infusion daily for 5 days at a dose of 20 mg/m2 followed on Day 8 by alvocidib as a loading dose over 30 minutes followed by a 4-hour IV infusion (hybrid dosing) Once the maximum dose of alvocidib administered via hybrid dosing has been determined, 2 cohorts of patients will receive azacitidine followed by alvocidib administered as an IV infusion. Azacitidine may be administered as either an IV bolus over 10 to 40 minutes or as a subcutaneous (SC) injection on either a 7 day or 5-2 2 schedule. Regardless of which azacitidine schedule or route of administration is used, alvocidib will be given on Day 10 as a 30-to-60 minute IVI
~PHASE 2:
~The Phase 2 study will use the RP2D from the Phase 1b study and follow a Simon 2-stage minimax design using the RP2D of alvocidib administered as a 30-to-60 minute IV infusion determined in the Ph1b study to explore efficacy of alvocidib when administered in sequence after azacitidine."
16405313|NCT03587311|Biological|Anetumab Ravtansine|Given IV
16405314|NCT03587311|Biological|Bevacizumab|Given IV
16405315|NCT03587311|Drug|Paclitaxel|Given IV
16405316|NCT03558217|Device|Collared Femoral Implant|Corail collared femoral implant for total hip arthroplasty
16405317|NCT03558217|Device|Collarless Femoral Implant|Corail collarless femoral implant for total hip arthroplasty
16405318|NCT03542669|Drug|6B11-OCIK Injection|Two infusions of 6B11-OCIK will be performed at each chemotherapy cycle (Day 3 an Day 7) during the first three cycles, while PBMC will be collected before each cycle (Day -12) during the first three cycles.
16405319|NCT03542669|Drug|Doxorubicin|Subjects will be adminitered 4~6 cycles of chemotherapy (Doxorubicin, 30 mg/m^2 IV on Day 1 of every cycle)
16405322|NCT03535740|Drug|Brigatinib|Brigatinib Tablets
16405323|NCT03534375|Other|The study is an observational cross sectional study|An intervention will not be performed
16405324|NCT03516708|Drug|Epacadostat|Self-administered orally BID without regard to food
16405325|NCT03516708|Procedure|Tumor biopsy|"Washington University patients only
~Baseline (no more than 28 days prior to Day 1 of RT) (this is standard of care from the diagnostic biopsy)
~Between the end of RT and prior to initiation of chemotherapy via proctoscopy or sigmoidoscopy (target days 5-28)
~Surgery (part of the resection specimen) or at the time of SOC pre-surgical proctoscopy"
16405326|NCT03516708|Procedure|Peripheral blood draw|"Baseline (no more than 28 days prior to Day 1 of RT) (this is standard of care from the diagnostic biopsy)
~Day 1 of each chemotherapy cycle (target days 5-28)
~Surgery (part of the resection specimen) or at the time of SOC pre-surgical proctoscopy"
16405327|NCT03514329|Device|Bronchoscopic Thermal Vapor Ablation|Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.
16405328|NCT03509636|Drug|Fluzoparib|Fluzoparib capsule will be given twice daily orally
16405329|NCT03497897|Drug|LYS006|Oral administration
16405330|NCT03497897|Drug|Placebo|Oral administration
16405333|NCT03488628|Other|Noninvasive ventilation|Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
16405334|NCT03488628|Other|High-Flow Nasal Oxygen therapy|High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher & Paykel Healthcare,New Zealand) through nasal canula.
16405335|NCT03472586|Biological|Ipilimumab|Given IV
16405336|NCT03472586|Biological|Nivolumab|Given IV
16405337|NCT03472586|Drug|Embolization Therapy|Undergo immunoembolization
16405338|NCT03456817|Drug|Treatment Arm - high dose ATG|Patients agreeing to high dose ATG will be treated with 2 mg/kg daily on days -4 to 0. On days -4, -3 & -2, ATG will be infused after fludarabine & busulfan infusion. ATG will be infused over a minimum of 6 hrs on day -4 & over at least 4 hrs on days -3, -2, -1 & 0. Dose is based on actual body wt, & rounded to nearest vial-Thymoglobulin is supplied in 25 mg vials, except if rounding would result in >5% difference from calculated dose. Foothills Medical Center Unit 57 standard practice followed for ATG infusion. ATG premeds include methylprednisolone, diphenhydramine, and an antipyretic. Meperidine 25-50 mg IVPB every 4 hours will be given as needed for rigors. MTX is given 15 mg/m2 IV on day +1 & 10 mg/m2 on days +3, +6 & +11 posttransplant. First dose of methotrexate is given on day +1, at least 24 hrs following end of infusion of stem cell product.
16405339|NCT03456817|Drug|Control Arm - standard of care|The historical controls will have received and the concurrent controls will receive our standard GVHD prophylaxis, ie, ATG 4.5 mg/kg i.v. (0.5 mg/kg on day -2, 2.0 mg/kg on day -1 and 2.0 mg/kg on day 0), MTX (15 mg/m2 i.v. on day 1 and 10 mg/m2 i.v. on days 3, 6 and 11) and CSA (2.5 mg/kg twice a day i.v. starting from day -1, adjusting dose to target trough plasma CSA levels of 200-400 microg/L, switching to oral formulation before discharge from peritransplant hospitalization, targeting the trough plasma levels of 200-400 microg/L until day 56, and tapering to zero between day 56 and 84).
16405375|NCT03367793|Device|Spectacles - Clinically Derived|Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
16405340|NCT03456778|Procedure|Platelet-Rich Plasma Injection|7 cubic centimeters (cc) of blood will be collected and processed for the PRP injection. The site to be injected will be prepared with isopropyl alcohol and then sprayed with ethyl chloride to achieve cutaneous anesthesia. Next, with continuous sonographic visualization, the skin and subcutaneous tissues overlying the posterior mid-Achilles tendon will be infiltrated with 0.5% bupivacaine and 1% sodium bicarbonate (50 milliequivalents (mEq)/50 mL) via a 25-gauge hypodermic needle. Once adequate anesthesia is achieved, a 20-gauge needle will be used to repeatedly fenestrate the tendinotic portion of the tendon along the long plane. Any calcifications within the substance of the tendon will be mechanically fragmented. When the region of interest has been treated, a PRP injection (5 cc) will be delivered. Each patient will then be provided a post-procedure care form with specific information regarding initial physical activity limitation and return to normal activity.
16405341|NCT03441113|Drug|MMB|Tablet(s) administered orally once daily
16405342|NCT03440047|Device|Fuji Flim Processor VP-7000, Light Source BL-7000|Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
16405343|NCT03430843|Drug|Tislelizumab|200 mg administered intravenously (IV)
16405344|NCT03430843|Drug|Paclitaxel|135-175 mg /m² administered IV given every 21 days, or 80-100mg/m2 administered IV weekly
16405345|NCT03430843|Drug|Docetaxel|75 mg/m2 administered IV
16405346|NCT03430843|Drug|Irinotecan|125mg/m2 administered IV
16405347|NCT03429218|Drug|TP-0184|Oral dose once weekly for 4 weeks
16405348|NCT03425565|Drug|Pembrolizumab|3 weekly cycles of Pembrolizumab administered by IV
16405349|NCT03424915|Behavioral|Harvard Health Professionals survey|Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.
16405350|NCT03424915|Other|Blood draw|Participant will provide a blood sample
16405351|NCT03424915|Other|CPET Procedures|CPET with 12-lead ECG
16405352|NCT03424915|Other|stool sample|Research stool sample (within ±1 week of surgery), if possible
16405353|NCT03424915|Procedure|Research Tissue sampling|Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.
16405354|NCT03423680|Drug|Abilify 2, 5, 10, 15mg (Tablet)|Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
16405355|NCT03423680|Drug|Placebo of Abilify 2, 5, 10, 15mg (Tablet)|Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
16405356|NCT03414047|Drug|Prexasertib|Administered IV
16405357|NCT03408665|Radiation|SBRT|3 sessions at least, up to 6. Neither specifc device is imposed.
16405361|NCT03393468|Drug|Dapivirine gel|Dapivirine gel (0.05%); administered rectally
16405362|NCT03384654|Drug|Daratumumab|Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.
16405363|NCT03384654|Drug|Vincristine|Participant will receive vincristine 1.5 milligram per meter square (mg/m^2) in cohort 1 and cohort 2.
16405364|NCT03384654|Drug|Prednisone|Participant will receive prednisone 40 mg/m^2 in cohort 1 and cohort 2.
16405365|NCT03384654|Drug|Doxorubicin|Participant will receive doxorubicin 60 mg/m^2 in cohort 2.
16405366|NCT03384654|Biological|Peg-asparaginase|Participant will receive peg-asparaginase 2500 units per meter square (U/m^2) in cohort 2.
16405367|NCT03384654|Drug|Cyclophosphamide|Participant will receive cyclophosphamide 1 gram per meter square (g/m^2) once in cohort 2.
16405368|NCT03384654|Drug|Cytarabine|Participant will receive cytarabine 75 mg/m^2 in cohort 2.
16405369|NCT03384654|Drug|6-mercaptopurine|Participant will receive 6-mercaptopurine 60 mg/m^2 orally daily in cohort 2.
16405370|NCT03384654|Drug|Methotrexate|Participant will receive methotrexate 5 g/m^2 intravenously (IV) in cohort 2.
16405371|NCT03374137|Biological|obinutuzumab|Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.
16405372|NCT03371667|Drug|Methotrexate|"Methotrexate 5 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.
~Methotrexate will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.
~For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).
~All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.
~Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103."
16405373|NCT03371667|Drug|Placebo|"Placebo 5 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.
~Placebo will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.
~For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).
~All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.
~Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103."
16405374|NCT03368625|Radiation|Stereotactic Radiosurgery|Stereotactic Radiosurgery before surgical resection of brain mets.
16405376|NCT03367793|Device|Spectacles - Metric Technique #1 Derived|Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
16405377|NCT03367793|Device|Spectacles - Metric Technique #2 Derived|Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
16405378|NCT03343834|Biological|biological collection|"At D0:
~blood samples
~saliva sample
~At D8: blood sample
~the results will be compared to the analysis of EBV transcripts that are specific for the latent or replicative phase of the virus by reverse transcription-quantitative PCR (RT-qPCR), and to the detection of free virus in the saliva, which is associated with viral reactivation"
16405379|NCT03342937|Drug|Oxaliplatin+Capecitabine+Pembrolizumab|"For each cycle: Oxaliplatin 130 mg/m2 IV on Day1, Capecitabine 825 or 1000 mg/m2 PO, BID Days on Days1-14, Pembrolizumab 200 mg IV on Day 1.
~This study has 2 parts:
~Safety validation part: all Cycles are 21 days in length.
~Dose Expansion part: Cycle 1 is 28 days in length. Cycle 2 and beyond are 21 days."
16405384|NCT03318900|Biological|Aldesleukin|Given IV
16405385|NCT03318900|Drug|CD8-Positive T-Lymphocyte|Given IV
16405386|NCT03318900|Drug|Cyclophosphamide|Given IV
16405387|NCT03318900|Procedure|Leukapheresis|Undergo leukapheresis
16405388|NCT03318900|Biological|Utomilumab|Given IV
16405393|NCT03301831|Behavioral|Resourcefulness Training|Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
16405394|NCT03295981|Drug|Zoledronic Acid|4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement
16405395|NCT03282955|Drug|Lipidem|Lipoplus i.v. lipid emulsion for parenteral nutrition
16405396|NCT03282955|Drug|Lipofundin MCT 20%|Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
16405397|NCT03278717|Drug|Olaparib|Olaparib is a PARP inhibitor, targeting DNA repair processes.
16405398|NCT03278717|Drug|Cediranib|Cediranib is an inhibitor of vascular endothelial growth factor-A (VEGF), targeting angiogenesis.
16405399|NCT03278106|Other|Laboratory Biomarker Analysis|Correlative studies
16405400|NCT03278106|Drug|Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102|Given PO
16405401|NCT03276351|Device|Long-Stemmed with Hybrid Fixation|Long-stemmed revision implant with hybrid fixation for total knee arthroplasty
16405402|NCT03276351|Device|Short-Stemmed with Augmented Fixation|Short-stemmed primary implant with augmented fixation for total knee arthroplasty
16405403|NCT03275103|Drug|Cevostamab|Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
16405404|NCT03275103|Drug|Tocilizumab|Tocilizumab will be administered as premedication during Cycle 1.
16405405|NCT03270527|Other|High SFA diet (Diet 1)|'Diet 1' will contain ~18% of its total energy as SFA .
16405406|NCT03270527|Other|Low SFA diet (Diet 2)|'Diet 2' will contain ~10% of its total energy as SFA. The SFA-replacement fats will be mixture of PUFA/MUFA.
16405408|NCT03259763|Device|Lumen-apposing metal stent|In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
16405409|NCT03259763|Device|Self-expandable metal stent|In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
16405451|NCT03064490|Drug|Pembrolizumab|Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
16405452|NCT03055013|Procedure|Nephrectomy|Undergo nephrectomy
16405453|NCT03055013|Biological|Nivolumab|Given IV
16405454|NCT03055013|Other|Patient Observation|Undergo observation
16405412|NCT03219164|Drug|AZLI|75 mg/ml of aztreonam administered thrice daily via the PARI Altera® Nebulizer System. Participants < 2 years will receive via the SmartMask® Baby, 2 to < 6 years via the SmartMask Kids® and > 6 years via the nebulizer mouthpiece.
16405413|NCT03219164|Drug|Placebo|Placebo administered thrice daily via the PARI Altera® Nebulizer System. Participants < 2 years will receive via the SmartMask® Baby, 2 to < 6 years via the SmartMask Kids® and > 6 years via the nebulizer mouthpiece.
16405421|NCT03198156|Device|Transcranial Direct Current Stimulation|tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.
16405422|NCT03198156|Device|Sham stimulation|Sham stimulation
16405423|NCT03185897|Other|Non-treatment, seroprevalence|Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)
16405424|NCT03181204|Procedure|Bronchial biopsy|The bronchial biopsy is part of this study's inclusion criteria and is required during routine care for the patient. Bronchial fibroscopy is performed under general or local anesthesia. Biopsies are performed using forceps and according to current recommendations. One biopsy will be fixed immediately in RCL2 medium while the others (between 3 and 6) will be kept in isotonic saline and rapidly prepared for air-liquid-interface (ALI) cell culture.
16405425|NCT03181204|Procedure|Skin biopsy|The skin biopsy will be performed after local anesthesia by hypodermic injection of a 1% Xylocaine solution. A single sample of a skin fragment about 3 mm in diameter will be necessary.
16405426|NCT03181204|Procedure|Blood sample|The blood sample will be taken at the end of the cutaneous biospy, approximately 20 ml of blood will be collected.
16405427|NCT03178552|Drug|Alectinib|Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
16405428|NCT03178552|Drug|Atezolizumab|Participants will receive atezolizumab 1200 mg IV infusion Q21D (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).
16405429|NCT03178552|Drug|Pemetrexed|Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
16405430|NCT03178552|Drug|Cisplatin|Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
16405431|NCT03178552|Drug|Carboplatin|Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
16405432|NCT03178552|Drug|Gemcitabine|Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
16405433|NCT03178552|Drug|Entrectinib|Participants will receive entrectinib 600 mg orally QD.
16405434|NCT03178552|Drug|Cobimetinib|Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
16405435|NCT03178552|Drug|Vemurafenib|Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.
16405436|NCT03178552|Drug|Bevacizumab|Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
16405437|NCT03126630|Biological|Anetumab Ravtansine|Given IV
16405438|NCT03126630|Other|Laboratory Biomarker Analysis|Correlative studies
16405439|NCT03126630|Biological|Pembrolizumab|Given IV
16405440|NCT03126630|Other|Pharmacological Study|Correlative studies
16405441|NCT03121001|Drug|ATG|0.5 mg/kg IV on day -9, and 2 mg/kg on days -8 and day -7
16405442|NCT03121001|Drug|fludarabine|30 mg/m2 IVPB daily for day -6 (6 days before stem cell infusion) through day -2
16405443|NCT03121001|Drug|cyclophosphamide|14.5 mg/kg IV on days -6 and -5 and 50 mg/kg/d on days +3 and +4
16405444|NCT03121001|Radiation|Total body irradiation|3 Gy on day -1
16405445|NCT03121001|Procedure|Stem cell infusion|Stem cell product infused according to BMT unit policy on day 0.
16405446|NCT03121001|Drug|Sirolimus|loading dose of 15 mg followed by 5 mg per day on day +5
16405447|NCT03121001|Drug|mycophenolate mofetil|1 g every 8 h (until day 35) will be started on day 5
16405448|NCT03115333|Diagnostic Test|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo DSC-MRI
16405449|NCT03073525|Biological|Vigil|Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).
16405450|NCT03073525|Drug|Atezolizumab|Atezolizumab is provided in a single-use, 20-cc USP/Ph. Eur. Type 1 glass vial as a colorless to slightly-yellow, sterile, preservative-free clear liquid solution intended for IV administration. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. The atezolizumab drug product is formulated as 60 mg/mL atezolizumab in 20 mM histidine acetate, 120 mM sucrose, 0.04% polysorbate 20, pH 5.8 (Phase III formulation).
16405455|NCT03055013|Other|Quality-of-Life Assessment|Ancillary studies
16405468|NCT02993146|Other|Laboratory Biomarker Analysis|Correlative studies
16405469|NCT02993146|Other|Pharmacological Study|Correlative studies
16405470|NCT02993146|Other|Quality-of-Life Assessment|Ancillary studies
16405471|NCT02993146|Drug|Ropidoxuridine|Given PO
16405472|NCT02993146|Radiation|Whole-Brain Radiotherapy|Undergo WBRT
16405474|NCT02978118|Device|Immune cell and CTC detection procedures|Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
16405475|NCT02974725|Drug|LXH254|LXH254 will be supplied as tablet for oral use.
16405476|NCT02974725|Drug|LTT462|LTT462 will be supplied as hard gelatin capsule for oral use.
16405477|NCT02974725|Drug|Trametinib|Trametinib will be supplied as film-coated tablet for oral use
16405478|NCT02974725|Drug|LXH254|Trametinib will be supplied as film-coated tablet for oral use
16405479|NCT02974725|Drug|Ribociclib|Ribociclib will be supplied in tablets and hard gelatin capsules.
16405480|NCT02965898|Dietary Supplement|Vitamin D 100ug|Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
16405481|NCT02965898|Dietary Supplement|Vitamin D 10ug|Placebo dose. Minimal recommended dose.
16405482|NCT02952222|Drug|Dexmedetomidine|Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
16405483|NCT02952222|Drug|Propofol (Group P)|Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.
16405484|NCT02952222|Drug|Propofol (Group DP)|Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
16405485|NCT02924402|Biological|XmAb13676|Biological
16405486|NCT02922764|Drug|RGX-104|
16405487|NCT02922764|Drug|Nivolumab|
16405488|NCT02922764|Drug|Ipilimumab|
16405489|NCT02922764|Drug|Docetaxel|
16405490|NCT02922764|Drug|Pembrolizumab|
16405491|NCT02922764|Drug|Carboplatin|
16405492|NCT02922764|Drug|Pemetrexed|
16405499|NCT02901548|Drug|Durvalumab|Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses.
16405500|NCT02901548|Procedure|Cystoscopy with Biopsy|Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
16405501|NCT02890069|Biological|PDR001|anti-PD1 antibody
16405502|NCT02890069|Drug|LCL161|
16405503|NCT02890069|Drug|Everolimus|
16405504|NCT02890069|Drug|Panobinostat|
16405505|NCT02890069|Drug|QBM076|
16405506|NCT02890069|Drug|HDM201|
16405507|NCT02874092|Drug|Ticagrelor|
16405508|NCT02874092|Drug|MTX therapy|
16405509|NCT02840383|Other|Delayed Intervention|Schools not receiving intervention until two years after implementation.
16405510|NCT02840383|Other|Intervention|intervention at the beginning of study.
16405527|NCT02746081|Drug|BAY1436032|The selected starting dose of BAY1436032 is 300 mg/day (150 mg BID) to be administered orally continuously in tablet form in 21-day cycles. Adjustments to this schedule may be made if warranted by information collected during the course of the study. The maximum feasible dose of BAY1436032 is expected to be 3000 mg/day.
16405528|NCT02728102|Procedure|Tumor Cell Collection|Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
16405529|NCT02728102|Procedure|Autologous Stem Cell Transplant|Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
16405530|NCT02728102|Drug|Melphalan|Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.
16405531|NCT02728102|Procedure|Leukapheresis|Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.
16405532|NCT02728102|Biological|Myeloma vaccine|The target dose is 3 x 10^6 fusion cells per vaccine. A minimum of 3 x 10^6 total fusion cells will be required to proceed with vaccine administration. Patients who have <3 x 10^6 total fusion cells will not proceed with vaccination. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance. Vaccine will be administered by subcutaneous injection in the upper thigh.
16405533|NCT02728102|Drug|GM-CSF|100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
16405534|NCT02728102|Drug|Lenalidomide|Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
16405535|NCT02720068|Biological|Favezelimab|IV infusion
16405536|NCT02720068|Biological|Pembrolizumab|IV infusion
16405537|NCT02720068|Drug|Oxaliplatin|IV infusion
16405538|NCT02720068|Drug|Irinotecan|IV infusion
16405539|NCT02720068|Drug|Leucovorin (Calcium Folinate)|IV infusion
16405540|NCT02720068|Drug|Fluorouracil [5-FU]|IV infusion
16405541|NCT02720068|Biological|Favezelimab/Pembrolizumab|IV infusion
16405542|NCT02720068|Drug|Lenvatinib|Oral
16405543|NCT02709694|Other|No intervention|No drug or device intervention. However, participants will receive MRI of their spine, answer questionnaires, provide clinical history as well as blood and stool sample. Joint exams will also be performed on all participants.
16405544|NCT02702115|Biological|SB-318|A single dose of each of the three components of SB-318 [zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)] administered via intravenous (IV) infusion.
16405545|NCT02678689|Biological|BMN190 recombinant human tripeptidyl peptidase-1 (rhTPP1)|
16405546|NCT02678689|Device|Intraventricular access device|Surgical implantation of an MRI compatible ICV access device in the lateral ventricle of the right hemisphere is required for administration of study drug.
16405547|NCT02675244|Procedure|TV Annuloplasty|TV Annuloplasty will be performed using standard surgical techniques
16405548|NCT02675244|Procedure|MVS|MVS will be performed using standard surgical techniques
16405549|NCT02673320|Procedure|Early surgery within 48 hours|After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized. After obtaining the signed consent form, the patient was included in the protocol. After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, early surgery is then realised within 48 hours. The surgical technique is a conventional cervical spinal decompression surgery. Surgery by way posterior surgery, by laminectomy in case of significant spinal stenosis greater than or equal to 3 floors will be preferred. In other cases, the type of surgery will be at the discretion of the surgeon. Then, the follow-up visits are D7, M3, Y1 and Y2.
16405550|NCT02673320|Procedure|Delayed surgery at 15 days|After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized. After obtaining the signed consent form, the patient was included in the protocol. After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, delayed surgery is then realised at 15 days. The surgical technique is a conventional cervical spinal decompression surgery. Surgery by way posterior surgery, by laminectomy in case of significant spinal stenosis greater than or equal to 3 floors will be preferred. In other cases, the type of surgery will be at the discretion of the surgeon. Then, the follow-up visits are D7, M3, Y1 and Y2.
16405552|NCT02667912|Procedure|Distal renal denervation|Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to segmental branches of the renal artery in a number of points distributed along the length and circumference of the vessels in order to ablate renal nerve plexus
16405553|NCT02667912|Procedure|Conventional renal denervation|Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to the main trunk of the renal artery in a number of points equally distributed along its length and circumference in order to ablate renal nerve plexus
16405554|NCT02667587|Drug|Nivolumab|
16405555|NCT02667587|Drug|Temozolomide|
16405556|NCT02667587|Radiation|Radiotherapy|
16405557|NCT02667587|Other|Nivolumab Placebo|
16405558|NCT02660645|Drug|Hexaminolevulinate hydrochloride (HCL)|Instillation in bladder
16405559|NCT02660645|Device|Karl Storz D-Light C Photodynamic Diagnostic (PDD) system|Cystoscopy procedure
16405560|NCT02640664|Drug|Ranibizumab|0.2 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
16405561|NCT02640664|Drug|Ranibizumab|0.1 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
16405564|NCT02633501|Drug|P03277|Single intravenous (IV) bolus injection at a rate of 2 mL/second
16405565|NCT02633501|Drug|Gadobenate dimeglumine|Single IV bolus injection at a rate of 2 mL/second
16405566|NCT02633501|Device|MRI|
16405567|NCT02600208|Biological|CliniMACs|Depletion of Alpha Beta T cells in the PBSC graft
16405568|NCT02595593|Device|Rib Fixation System|This intervention involves a surgical procedure to affix rib plates to broken ribs
16405569|NCT02576431|Drug|BAY2757556 (Larotrectinib, Vitrakvi)|Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.
16405570|NCT02570100|Procedure|Biological collection|"Collection of blood samples and tumor specimens :
~Biological collection before treatment :
~1 tumor specimen (under echographic control)
~4 blood collections
~Biological collection during treatment :
~1 tumor specimen after 3 cycles
~4 blood collections after 3 and 6 cycles"
16405571|NCT02568553|Biological|Blinatumomab|Given IV
16405572|NCT02568553|Drug|Lenalidomide|Given PO
16405573|NCT02563015|Dietary Supplement|cholecalciferol|liquid drops
16405574|NCT02563015|Dietary Supplement|Reference 400|liquid drops
16405575|NCT02543255|Drug|Abiraterone acetate with prednisone|Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.
16405576|NCT02543255|Drug|Leuprolide|Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.
16405577|NCT02543255|Drug|Cabazitaxel with peg-filgrastim|Cabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles.
16405584|NCT02531932|Drug|Carboplatin|Carboplatin will be administered if ANC > 1.0 and platelets are >75k
16405585|NCT02531932|Drug|Everolimus|The study drug Everolimus will be self-administered (by the patients themselves).
16405588|NCT02509507|Drug|Talimogene Laherparepvec|Talimogene laherparepvec (T-VEC) administered by intralesional injection into liver tumors, with US/CT guidance. Part 1: initial dose of T-VEC is 10^6 PFU/mL up to 4mL in Cohorts 1 & 2, up to 8mL in Cohorts 3 & 4 of the Group A & Group B. The 1st cycle of T-VEC will be 21 (+3) days (from the 1st dose at 10^6 PFU/mL to the 2nd dose at 10^7 or 10^8 PFU/mL). Subsequent cycles of T-VEC will be 21 (±3) days. Max. volume of T-VEC administered at any dose is 4mL (Cohorts 1, 2, 5, and 6) or 8mL (Cohorts 3 & 4) for any individual lesion or for all lesions combined. Part 2: Initial dose of T-VEC is 10^6 PFU/mL followed by subsequent T-VEC doses at a concentration of 10^8 PFU/mL. T-VEC volume is up to 8mL based on the size of the inejected lesions.
16405589|NCT02509507|Drug|Pembrolizumab|Pembrolizumab is a non-Amgen Investigational product that is manufactured by Merck. Pembrolizumab will be labeled, packaged, and distributed by Amgen (or designee) using Amgen (or designee) clinical study drug distribution procedures. Pembrolizumab is supplied as pembrolizumab 100 mg/4 mL vials (25 mg/mL) solution for IV infusion. The trial treatment will consist of a total dose of 200mg administered intravenously every 3 weeks (day 1 of each cycle) for up to 35 cycles.
16405590|NCT02474355|Procedure|T790M+ Testing|If a previous lab report is unavailable, the patient will need to have T790M+ testing.
16405591|NCT02474355|Procedure|Baseline Visit Blood & Urine Testing|Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria
16405592|NCT02474355|Procedure|Baseline ECG|ECG to ensure absence of any cardiac abnormality
16405593|NCT02474355|Procedure|Visual Slit-Lamp Testing|Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms
16405594|NCT02474355|Drug|AZD9291 Dosing|Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)
16405605|NCT02465060|Drug|Binimetinib|Given PO
16405606|NCT02465060|Drug|Capivasertib|Given PO
16405607|NCT02465060|Drug|Copanlisib|Given IV
16405608|NCT02465060|Drug|Copanlisib Hydrochloride|Given IV
16405609|NCT02465060|Drug|Crizotinib|Given PO
16405610|NCT02465060|Other|Cytology Specimen Collection Procedure|Optional correlative studies
16405611|NCT02465060|Drug|Dabrafenib|Given PO
16405612|NCT02465060|Drug|Dabrafenib Mesylate|Given PO
16405613|NCT02465060|Drug|Dasatinib|Given PO
16405614|NCT02465060|Drug|Defactinib|Given PO
16405615|NCT02465060|Drug|Defactinib Hydrochloride|Given PO
16405616|NCT02465060|Drug|Erdafitinib|Given PO
16405617|NCT02465060|Drug|FGFR Inhibitor AZD4547|Given PO
16405618|NCT02465060|Drug|Ipatasertib|Given PO
16405619|NCT02465060|Other|Laboratory Biomarker Analysis|Undergo molecular analysis
16405620|NCT02465060|Drug|Larotrectinib|Given PO
16405621|NCT02465060|Drug|Larotrectinib Sulfate|Given PO
16405622|NCT02465060|Biological|Nivolumab|Given IV
16405623|NCT02465060|Drug|Osimertinib|Given PO
16405624|NCT02465060|Drug|Palbociclib|Given PO
16405625|NCT02465060|Biological|Pertuzumab|Given IV
16405626|NCT02465060|Drug|PI3K-beta Inhibitor GSK2636771|Given PO
16405627|NCT02465060|Biological|Relatlimab|Given IV
16405628|NCT02465060|Drug|Sapanisertib|Given PO
16405629|NCT02465060|Drug|Sunitinib Malate|Given PO
16405630|NCT02465060|Drug|Taselisib|Given PO
16405631|NCT02465060|Drug|Trametinib|Given PO
16405632|NCT02465060|Biological|Trastuzumab|Given IV
16405633|NCT02465060|Biological|Trastuzumab Emtansine|Given IV
16405634|NCT02465060|Drug|Ulixertinib|Give PO
16405635|NCT02465060|Drug|Vismodegib|Given PO
16405636|NCT02447692|Other|PSV ventilation strategy|An algorithm for adjusting the level of pressure support according to usual clinical parameters; patients not tolerating PSV will be switched to Assist/Control mode according to predefined criteria
16405637|NCT02447692|Other|PAV+ ventilation strategy|An algorithm for adjusting the level of support (gain) to maintain a predefined range of respiratory muscle pressure; patients not tolerating PAV+ (Puritan Bennett™ 840 or 980 ventilator) will be switched to Assist/Control mode according to predefined criteria
16405638|NCT02434081|Drug|Nivolumab|Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
16405639|NCT02412982|Drug|Enoxaparin 40 mg q12h|Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.
16405640|NCT02412982|Drug|Enoxaparin 30 mg q8h|Patients receive enoxaparin 30 mg every 8 hours.
16405641|NCT02390752|Drug|Turalio|take oral drug daily for a 28 day cycle
16405642|NCT02356302|Device|Vicriviroc (MK-4176) Intravaginal Ring (IVR)|Contains 182 mg vicriviroc (MK-4176).
16405643|NCT02356302|Device|MK-2048 IVR|Contains 30 mg MK-2048.
16405644|NCT02356302|Device|MK-2048A IVR|Contains 182 mg vicriviroc (MK-4176) and 30 mg MK-2048.
16405645|NCT02356302|Device|Placebo IVR|
16405653|NCT02344420|Procedure|Echocardiography|"The devices used within the study are the legally marked CRT devices from BIOTRONIK. CRT-P and CRT-D. As this is a post market study, all devices have a CE label and are used within their intended use. There are no study specific limitations nor mandatory device settings for the study.
~Subjects will undergo a standard echo assessment at baseline, 6 and 12 month follow up visit in order to assess the baseline characteristics and the changes as response to resynchronization."
16405654|NCT02344420|Behavioral|Minnesota Living Heart Failure Questionnaire (MLHF)|MLHF will be obtained at baseline, 6 and 12 month FU. The goal of this questionnaire is to measure the subjects perception of how their heart failure and treatment affect their life. Questions are focused on physical, socio-economic, and psychological impairments that persons with congestive heart failure frequently attribute to their condition.
16405655|NCT02344420|Procedure|Six minute walk test|The test will be performed at baseline, 6 and 12 month FU. The purpose of the test is to determine how far a patient can walk in six minute and relate it with the heart failure.
16405656|NCT02344420|Behavioral|Self assessment score|patient will complete a self assessment questionnaire at 2, 6 and 12 month FU for the calculation of the Packer Score at 12 month.
16406871|NCT04430036|Drug|Cisplatin|Alkylating antineoplastic agent
16405657|NCT02344290|Drug|Pitavastatin|One tablet (4 mg) taken once daily, orally with or without food
16405658|NCT02344290|Drug|Placebo|One tablet taken once daily, orally with or without food
16405662|NCT02337829|Drug|Acalabrutinib (Arm A)|"A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
~A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
~A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
~A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z"
16405663|NCT02337829|Drug|Acalabrutinib (Arm B)|"B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;
~• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y."
16405664|NCT02332798|Drug|PF-04958242|Administered as specified in the treatment arm
16405665|NCT02332798|Drug|Placebo|Administered as specified in the treatment arm
16405666|NCT02314403|Drug|Belatacept|A selective T-cell (lymphocyte) costimulation blocker
16405667|NCT02314403|Drug|ATG|A T-Cell Depleting Agent
16405668|NCT02314403|Drug|Rituximab|B-Cell Depleting Agent
16405669|NCT02314403|Radiation|Total Body Irradiation|
16405670|NCT02314403|Radiation|Thymic Irradiation|
16405671|NCT02314403|Procedure|Combined Bone Marrow/Kidney Transplantation|
16405672|NCT02264678|Drug|Administration of ceralasertib in combination with carboplatin|An oral formulation of ceralasertib will be used. In Module 1 Part A, patients will receive a single dose of ceralasertib on Day 1, followed by multiple dosing in combination with carboplatin. A maximum of 6 cycles (21 days per cycle) of treatment will be given. In Module 1 Part B, patients will receive ceralasertib and carboplatin at the dose, frequency and schedule recommended from Module 1 Part A.
16405673|NCT02264678|Drug|Administration of ceralasertib|An oral formulation of ceralasertib will be used. In Module 2 Part A1, patients will receive a single dose of ceralasertib on Day 1, followed by 4 to 6 days washout, before multiple dosing.
16405674|NCT02264678|Drug|Administration of ceralasertib in combination with olaparib|An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
16405675|NCT02264678|Drug|Administation of ceralasertib in combination with durvalumab|An oral formulation of ceralasertib will be used. Durvalumab is given via IV infusion. In Module 3 Part A, patients will receive an initial single dose of ceralasertib on Day 1, followed by multiple dosing in combination with durvalumab. In Module 3 Serial Tumour Biopsy Extension and Part B expansion cohorts, patients will receive ceralasertib at the dose, frequency and schedule recommended from Module 3 Part A, in combination with durvalumab.
16405676|NCT02254278|Drug|Cisplatin|40 mg/m2 IV (intravenously) weekly for 6 weeks
16405677|NCT02254278|Radiation|IMRT 6 weeks|Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
16405678|NCT02254278|Radiation|IMRT 5 weeks|Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
16405686|NCT02205112|Drug|Nemonoxacin|
16405687|NCT02205112|Drug|Levofloxacin|
16405835|NCT00444535|Drug|bevacizumab|10 mg/kg intravenous bevacizumab (every two weeks)
16405711|NCT02141438|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.
16405712|NCT02133924|Drug|natalizumab|Natalizumab 300mg on days 0 and 14.
16405713|NCT02133924|Drug|steroids|Prednisone 2mg/kg/d (or methyl-prednisolone IV equivalent)
16405718|NCT02131584|Other|Questionnaire Administration|Ancillary studies
16405719|NCT02131584|Drug|Ruxolitinib Phosphate|Given PO
16405722|NCT02099058|Drug|Osimertinib|It is administered orally everyday.
16405723|NCT02099058|Drug|Nivolumab|It is an intravenous infusion administered every 14 days.
16405724|NCT02099058|Drug|Telisotuzumab vedotin|It is administered by infusion in 21-day dosing cycles.
16405725|NCT02099058|Drug|Telisotuzumab vedotin|It is administered by infusion in 28-day dosing cycles.
16405726|NCT02099058|Drug|Erlotinib|It is administered orally everyday.
16405727|NCT02086175|Drug|Imprime PGG|
16405728|NCT02086175|Drug|Rituximab|
16405729|NCT02075593|Drug|DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets|The DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablet is a purple, oval, biconvex tablets. The tablet contains 52.6 mg DTG sodium which is equivalent to 50 mg DTG free acid, 702 mg ABC sulphate which is equivalent to 600 mg ABC and 300 mg 3TC.
16405730|NCT02068196|Procedure|Blood sampling for Pre-existing immunity|Identify predictive biomarkers of long term study survivors who have substantially benefited from ipilimumab therapy
16405731|NCT02068196|Drug|Ipilimumab|
16405732|NCT02040714|Procedure|Osteotomy + Long Term Non-Weight Bearing|Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.
16405733|NCT02040714|Procedure|Osteotomy + Short Term Non-Weight Bearing|Surgical procedure that improves femoral head containment, plus a post-operative protocol that allows early return to function after 6 weeks of non-weight bearing.
16405734|NCT02040714|Procedure|Nonoperative Observation|Group will not undergo any surgical or invasive procedures during course of treatment.
16405735|NCT02040714|Procedure|Multiple Epiphyseal Drilling|Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.
16405738|NCT02009384|Drug|Ipilimumab|administration of IV ipilimumab for up to 4 cycles
16405739|NCT01995175|Procedure|Nasal swab sampling|Nasal swab samples will be collected from subjects at each examination visit, if they develop respiratory tract infection symptoms with difficulty in breathing and are called for an examination visit in the study.
16405740|NCT01995175|Procedure|Blood sampling|A single blood sample will be collected from a sub-cohort consisting of the first 2000 enrolled subjects when they are either 2, 4, 6, 12, 18 or 24 months old.
16405741|NCT01995175|Other|Diary cards|Diary cards will be provided to parents or LARs of the subjects to record RTI/LRTI, wheeze and asthma symptoms.
16405742|NCT01985087|Radiation|Hypofractionated radiotherapy|Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.
16405743|NCT01985087|Drug|Temozolomide|During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.
16405744|NCT01982968|Procedure|Surgery|Full fundoplication surgery for the treatment of abnormal GER
16405745|NCT01951586|Drug|Denosumab|Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
16405746|NCT01951586|Drug|Zoledronic acid|Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
16405747|NCT01951586|Drug|Placebo to Denosumab|Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
16405748|NCT01951586|Drug|Standard Chemotherapy|Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice.
16405972|NCT05094193|Procedure|TAP block placebo|bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side
16405749|NCT01951586|Drug|Placebo to Zoledronic Acid|Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
16405750|NCT01911767|Drug|Dimethyl fumarate|Administered as specified in treatment arm.
16405751|NCT01911767|Drug|Peginterferon beta-1a|Administered as specified in treatment arm.
16405752|NCT01889238|Drug|Enzalutamide|160 mg administered as four soft gelatin capsules orally once daily
16405754|NCT01860820|Device|Geko device|
16405755|NCT01847274|Drug|Active comparator: Niraparib|Niraparib vs placebo 2:1 ratio
16405756|NCT01847274|Drug|placebo|
16405762|NCT01714128|Drug|Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))|FES-PET/CT imaging
16405764|NCT01574170|Other|Construction of a prognostic score (non-drug intervention types)|Record of clinical, histological and biological data and questionnaires data in patients starting a third line metastatic until progression
16405766|NCT01572480|Drug|Carfilzomib|Carfilzomib (IV) 20-36 mg/m2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.
16405767|NCT01572480|Drug|Revlimid|Revlimid (PO) 25 mg/day, days 1 21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
16405768|NCT01572480|Drug|Dexamethasone|Dexamethasone (PO) 20 mg per dose on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle based on arm; until disease progression or unacceptable toxicity.
16405769|NCT01535885|Biological|Cytotoxic T Lymphocytes|Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.
16405770|NCT01506609|Drug|Placebo|
16405771|NCT01506609|Drug|Veliparib|
16405772|NCT01506609|Drug|Carboplatin|
16405773|NCT01506609|Drug|Temozolomide|
16405774|NCT01506609|Drug|Paclitaxel|
16405775|NCT01491893|Biological|Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)|Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)
16405786|NCT01290055|Biological|Yellow fever vaccine or YFV-17D|The YFV-17D (YF-VAX®) manufactured by Sanofi Pasteur as a one-dose vial will be purchased from the manufacturer. Vaccine will be stored at the Emory Investigational Drug service between 2o to 8o C as per the manufacturer's instructions. It will be transported to the Hope clinic per the Standard Operating Procedures.
16405787|NCT01290055|Other|Deuterium (70% enriched 2H2O) labeled water|70% enriched 2H2O will be obtained from Cambridge Isotope Laboratories (Andover, MA) in sterile 1L containers. An Emory IDS pharmacist will prepare sterile 50ml aliquots with a tamper seal which will be transported to the Hope clinic at room temperature.
16405790|NCT01256554|Procedure|Stereotactic Radiosurgery (SSRS)|Target dose of 18 or 24 Gy to spine in single session of radiation.
16405791|NCT01256554|Behavioral|Questionnaires|Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
16405796|NCT01214421|Drug|Tolvaptan|Tablets of 15 or 30 mg
16405804|NCT01175993|Other|Elliptical exercise|Each participant with TBI will participate in an exercise intervention which will be done in the home. The exercise device in this protocol will be an elliptical trainer that requires coordinated reciprocal movements of both the legs and the arms. Primary emphasis will be placed on maintaining a near maximal speed of movement and to progressively increase this over time. Mild resistance to the leg motion will be provided initially and will be progressively increased once speed and coordination are optimized. The device will be loaned to them to use in the home, and will be delivered to the home fully assembled. Participants will be monitored by phone the first week and thereafter every two weeks and progressed as indicated. The exercise program will be performed 5 days a week for 30 minutes per session, for a total duration of 12 weeks. All will record the length, speed and resistance of each session on a paper-based log sheet.
16405805|NCT01136759|Drug|Tenofovir 1% gel|One applicator of tenofovir 1% gel administered vaginally for 7 consecutive days
16405806|NCT01136759|Other|Placebo gel|One applicator of placebo gel administered vaginally for 7 consecutive days
16405807|NCT01071226|Device|CliniMACS (CD+3, CD+19 depletion)|Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
16405808|NCT01071226|Device|CliniMACS (CD 34+ positive selection)|Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection
16405809|NCT01071226|Other|HSCT|Peripheral Blood Stem Cell Transplant
16405812|NCT01008150|Drug|Paclitaxel|
16405813|NCT01008150|Drug|Trastuzumab|
16405814|NCT01008150|Drug|Neratinib|
16405815|NCT01008150|Drug|Doxorubicin|
16405816|NCT01008150|Drug|Cyclophosphamide|
16405819|NCT00975676|Other|gas chromatography / tandem mass spectometry|Determination of estrogen levels through gas chromatography.
16405828|NCT00540605|Drug|Tenofovir 1% vaginal gel|topical gel containing 1% tenofovir
16405829|NCT00464646|Drug|Epirubicin|Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles
16405830|NCT00464646|Drug|Cyclophosphamide|Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles
16405831|NCT00464646|Drug|Docetaxel|Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles
16405832|NCT00464646|Drug|Trastuzumab|"Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV
~Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses"
16405833|NCT00464646|Drug|Bevacizumab|"Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses
~Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses"
16405834|NCT00444535|Drug|lapatinib|1500 mg oral lapatinib (once daily)
16405836|NCT00272493|Biological|Hepatitis B virus vaccine with GM-CSF adjuvant|Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
16405837|NCT00272493|Biological|Hepatitis B virus vaccine|Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
16405838|NCT00110110|Biological|filgrastim|Given after chemo cycle for 7 days or until neutrophil counts return to normal.
16405839|NCT00110110|Drug|Carboplatin|Given at 28 mg/kg/dose.
16405840|NCT00110110|Drug|Cyclosporine|Given at 33 mg/kg/dose
16405841|NCT00110110|Drug|Etoposide|Given at 12 mg/kg/dose
16405842|NCT00110110|Drug|vincristine sulfate|Given at 0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated
16405843|NCT00110110|Procedure|cryosurgery|Local application of extreme cold to destroy residual tumor.
16405844|NCT00110110|Procedure|laser therapy|Local and precise application of laser beams to destroy residual tumor.
16405848|NCT00095498|Drug|placebo|placebo subcutaneous injection
16405849|NCT00095498|Drug|denosumab|For subcutaneous injection
16405850|NCT00090064|Drug|3,4-methylenedioxymethamphetamine|125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA
16405851|NCT00090064|Drug|Lactose placebo pill|125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo
16405852|NCT00090064|Behavioral|Therapy|Non-directive therapy provided by a team of two co-therapists
16405866|NCT05094986|Behavioral|Initial Medication Adherence (IMA) Intervention|The IMA intervention promotes health literacy and patient participation in the decision-making process during the recommendation and prescription of a new drug for the management of cardiovascular disease and diabetes. The IMA intervention has four main components: 1. Training for healthcare professionals (GPs, nurses, and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; 2. Intervention support tools; decision aids (leaflets and website) and implementation tools (dispensing alert in community pharmacies when dispensing insulins and antiplatelet drugs); 3. Shared decision-making process during the GP's consultation; and 4. Information support provided by the nurses and community pharmacists that use the intervention decision aids to explore the patients' doubts and standardise the discourse between primary healthcare professionals.
16405867|NCT05094986|Other|Usual Care|Patients received the usual care when being prescribed a new prescription for treatments of cardiovascular disease or diabetes. Nurses and community pharmacists were asked to also provide usual care to those patients. Community pharmacists from the control group had the dispensing alert available when dispensing insulins and antiplatelet drugs.
16405868|NCT05094973|Device|Carriere Motion Appliance®|To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® in a period of 4 months.
16405869|NCT05094960|Diagnostic Test|Blood samples|5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine
16405870|NCT05094947|Procedure|intermittent catheterization|clean intermittent catheterization with catheter Nelaton
16405871|NCT05094947|Procedure|trial without catheter|catheter Foley
16405872|NCT05094947|Drug|alpha-blockers|tamsulosin, alfuzosin, doxazosin, silodosin
16405873|NCT05094934|Drug|NNC0385-0434 A 100 mg|All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.
16405874|NCT05094921|Other|Aquatic Halliwick method|The Halliwick Concept is a detailed swimming programme based on the scientific principles of body mechanics and the properties of water intended to educate individuals with special needs to be water safe and to move independently in the water as much as possible (Lambeck & Stanat 2001a).The programme consists of 10 specific progressive stages that are achieved without the use of floatation devices (Lambeck & Stanat 2001b).
16405875|NCT05094921|Procedure|Conventional physical therapy|Conventional selected exercise program for 60 minutes ,3 session per week for 3 successive months aiming to improve the motor functions of the children in form of: (1) Neuro-developmental technique, (2) Back and abdominal exercises to improve postural control and correct spinal deformities (3) improving postural responses, (4) Flexibility exercises of the soft tissue (5) Strengthening exercise (particularly knee extensors, hip abductors and the ankle dorsi-flexors muscles and (6) Improving standing, weight transfer and shift and finally facilitation of normal walking pattern .
16405876|NCT05094908|Drug|Arnica Tincture|Arnika tincture is a topical plant-based preparation legally authorized in Colombia and in the countries of the European community, the product of this study is Arnika tinktur Gehrlicher (5249), manufactured by Gehrlicher Pharmazeutische Extrakte GmbH, Germany. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of A. montana L, and composed at least 0.04% of sesquiterpene lactones. Arnica tincture will be applied topically by each participant on all lesions until day 30 or 45, depending on the regimen to be evaluated.
16405877|NCT05094895|Procedure|Stretta|Radiofrequency energy delivered to the gastro-esophageal junction
16405878|NCT05094895|Procedure|Sham|Patients that have the sham condition will have a procedure using a 24Fr Savary bougie dilator over the guidewire, with the same sedation.
16405879|NCT05094882|Procedure|pulmonary lobectomy|resection of lung lobe
16405880|NCT05094869|Behavioral|Use of mobile health application|The APP would regularly send messages including the medication reminder, health education knowledge, etc.
16405881|NCT05094869|Behavioral|Online interaction|The patients would be able to upload their examination results in the APP and then the doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
16405882|NCT05094869|Behavioral|Self follow-up reminders|The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
16405883|NCT05094869|Behavioral|Intelligent follow-up reminders|The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)
16405884|NCT05094830|Procedure|Stomach Intestinal Pylorus-Sparing (SIPS) Procedure|The SIPS procedure will be performed as an investigational bariatric surgery. The SIPS procedure involves the creation of a standard sleeve gastrectomy over a 36-40 bougie. Division of the duodenum post-pylorus is performed, followed by the creation of a common channel 300 cm from the ileo-cecal valve. A hand-sewn anti-side duodenoileostomy is performed and the anastomosis tested for leaks through use of endoscopic insufflation and under water air leak test. Incisions are then closed in standard fashion. The SIPS procedure itself is not a separate surgery but rather a modification to the standard of care surgery.
16405885|NCT05094817|Other|Brain Health Assessment|BHA is a free, self-administered online cognitive screening test developed in Toronto at Baycrest (www.cogniciti.com). BHA has been validated against a gold standard neuropsychological assessment for detecting amnestic MCI (aMCI) - the most common type of MCI - in community dwelling older adults. BHA has high sensitivity (.78), specificity (.78), PPV (.82), NPV (.74), and was better than MoCA for identifying aMCI. ROC curves showed an AUC of 0.75 for detecting aMCI from normal subjects. BHA measures memory and executive attention processes sensitive to subtle cognitive changes associated with normal aging and MCI. BHA can be completed from a patient's home or can be self-administered in hospital.
16405886|NCT05094817|Other|Demographics questionnaire|To compare the sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who are not able to complete the BHA.
16405887|NCT05094817|Other|PHQ-2|PHQ-2 is a shortened version of PHQ-9 which is originally a component of the longer Patient Health Questionnaire. The tool incorporates DSM-IV depression criteria and other leading major depressive symptoms into brief self-reported instruments. PHQ-2 inquires about the degree to which an individual experiences depression and anhedonia (inability to feel pleasure) over the past two weeks. The tool is not for final diagnosis of depression or monitoring its severity but only for the purpose of screening for the condition.The questionnaire comprises of the first two questions from PHQ-9, each item is scored 0-3. Therefore, the PHQ-2 score ranges from 0-6.
16405888|NCT05094817|Other|AFT|AFT is a free, rapid cognitive assessment commonly used to assess semantic language ability. Language is one of the earliest functions affected by AD and naming and semantical knowledge seems to be particularly affected. The identification of language deficits may pick up signs of neurological decline preceding the appearance of clinical symptoms. Milder forms of cognitive impairment such as MCI may also show language deficits if language is one of the domains affected.
16405889|NCT05094817|Other|GAI-SF|GAI-SF is a 5-item questionnaire derived from the original 20-item Geriatric Anxiety Inventory (GAI).In the population of community dwelling older women GAI-SF was developed in, a cut-off score of 3 yields a specificity of 87% and sensitivity of 75%. This highly accessible questionnaire is suitable for everyday use in a range of health-care settings. It has been employed amongst older adults in primary care settings, nursing homes, geriatric psychiatry patients and amongst clinical geriatric participants with co-morbid anxiety and unipolar mood disorder and their controls.
16405890|NCT05094817|Other|pain VAS|The VAS is a unidimensional measure of pain intensity. The VAS tries to measure a continuous characteristic or attitude signifying the intensity or frequency of symptoms. The scale ranges from 0-10, with 0 = no pain to 10 = worst pain.
16405891|NCT05094817|Other|IADL|Instrumental activities such as preparing meals or managing finances allow individuals to maintain their health while living on their own. The IADL measures the ability of older adults to manage their daily activities, as well as the impact, if any, cognitive decline would have on these activities. Scores range from 0-5 for men, and 0-8 for women, with higher sores being more independent and higher functioning.
16406001|NCT05093959|Drug|Metformin|An extended release formulation will be used which improves compliance and reduces GI side effects.
16405892|NCT05094817|Other|FAM CAM|FAM-CAM was derived from the CAM instrument in order to screen for delirium by interviewing family members or caregivers of the patient. They are asked specific questions about any new or sudden changes in the patient's activity, behavioural or cognitive status. FAM-CAM showed good sensitivity and specificity in the original study where caregivers of elderly patients with pre-existing cognitive impairment were interviewed.
16405893|NCT05094817|Other|4AT|The 4AT is a rapid tool for delirium detection that has previously been used in a surgical setting. The 4Ats test for the patient's alertness, mental state, attention, and signs of acute change. Across 17 studies, the pooled sensitivity and specificity of 4AT was 0.86 and 0.89. The 4AT will be administered after the patient has completed surgery, prior to discharge.
16405894|NCT05094817|Other|BHA Usability Survey|The survey aims to assess system usability and acceptability based on standard questions adapted from the validated System Usability Scale. The questions evaluate satisfaction, experience with technology, and comfort level, as well as questions targeting usability concerns typically experienced by older adults, such as typeface and font size, consistent navigation, and writing style.
16405895|NCT05094817|Other|Clinical Frailty Scale|CFS is a 9-item scale that uses clinical descriptors and pictographs and is an easily applicable tool to stratify older adults according to level of vulnerability. The CFS divides patients into 9 classes from very fit (CFS = 1) to terminally ill (CFS = 9). It is easy to use and may readily be administered in a clinical setting, an advantage over the tools previously developed. The scale helps in objective early identification of older adults with frailty in acute care units and helps to target interventions to prevent complications and to implement effective discharge planning.
16405896|NCT05094804|Drug|OR2805|IgG1 monoclonal antibody that binds specifically to the CD163 protein.
16405897|NCT05094804|Drug|Pembrolizumab|IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and programmed cell death ligand 2 (PD-L2).
16405898|NCT05094804|Drug|Nivolumab|IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response.
16405899|NCT05094791|Device|Telescoping Lag Screw|Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw
16405900|NCT05094791|Device|Standard lag Screw|Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw
16405901|NCT05094791|Device|Standard lag screw with addition of worm screw|Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw
16405902|NCT05094778|Procedure|a single-portal palm approach|a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.
16405903|NCT05094765|Biological|FMT|Fecal Microbiota Transplantation
16405904|NCT05094752|Device|Proprioceptive stimulations|Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the intervention group will receive proprioceptive stimulations set to create illusions of movement.
16405905|NCT05094752|Device|Sham stimulations|Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the control group will receive sham stimulations.
16405906|NCT05094726|Radiation|photobiomodulation|Photobiomodulation (PBM) describes the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying.
16405907|NCT05094726|Other|placebo intervention by photobiomodulation device|placebo intervention while the photobiomodulation device is on the off mode
16405908|NCT05094713|Other|Flossing experimental group|Flossing of the tight muscles with medium wrapping pressure, which is individualized in based on the tight circumference of the participant.
16405909|NCT05094713|Other|Low wrapping pressure|Control group where flossing wrapping pressure is between 20 and 30 mmHg
16405910|NCT05094700|Other|Non-marketed Cosmetic Facial Cleanser|Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.
16405911|NCT05094674|Diagnostic Test|Breath Sample analysis|The participant's breath sample is taken by blowing preferably three times into a disposable tube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis. This will take place once during the study.
16405912|NCT05094661|Procedure|BiPAP|The patient recives respiratory support with bilevel positive airway pressure system until treatment improves or fails (needs intubation/dies).
16405913|NCT05094661|Procedure|CPAP|The patient recives respiratory support with continuous positive airway pressure system until treatment improves or fails (needs intubation/dies).
16405914|NCT05094648|Other|high flow nasal therapy|effect of high flow nasal therapy in covid 19 patients who pass and who need non invasive
16405915|NCT05094635|Diagnostic Test|SARS-CoV-2 IgG II Quant|3ml of blood samples are collected, contained in heparin-free tubes, and centrifuged. Blood serum samples are collected and stored at the -80 Celcius degree. SARS-CoV-2 IgG antibodies in human serum and plasma are detected using chemiluminescent microparticle immunoassay (CMIA) technology on the ARCHITECT I 1000r System. Quality Control procedures will take place once daily, with three levels: one negative control and two positive controls. Sample, SARS-CoV-2 antigen-coated paramagnetic microparticles, and assay diluent are combined and incubated. The SARS-CoV-2 IgG antibodies present in the sample bind to the antigen-coated microparticles. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the titres of IgG antibodies to SARS-CoV-2 in the sample and the RLU detected by the system optics. Interpretation of Results: < 50.0 AU/mL, Negative, ≥ 50.0 AU/mL, Positive
16405916|NCT05094622|Other|Physical exercise program|A specially designed exercise training program based on a previous study. The intervention of physical exercise will consist of different exercises to enhance muscle strength and endurance and will be individually adjusted and start in a different position with a progression in dose, intensity, and position. It will be performed 3 times /week during a period of 12-20 weeks.
16405917|NCT05094609|Biological|Ad5-triCoV/Mac|Ad5-triCoV/Mac is a recombinant type 5 human adenovirus vector which has been engineered to express our trivalent SARS-CoV-2 transgene cassette under the control of an MCMV promoter, and is followed by an SV40 polyA signal. The adenovirus construct is E1 and E3 deleted.This trivalent transgene cassette consists of the S1 region of SARS-CoV-2 spike protein (aa 47-716), full-length SARS-CoV-2 nucleoprotein (N) fused to a highly conserved portion of the SARS-CoV-2 polymerase (RdRp or POL).
16405918|NCT05094609|Biological|ChAd-triCoV/Mac|ChAd-triCoV/Mac is an E1 and E3 deleted chimpanzee adenovirus serotype 68 where the trivalent SARS-CoV-2 transgene cassette is under the control of an HCMV promoter and is followed by an SV40 polyA signal. The trivalent transgene cassette consists of the S1 region of SARS-CoV-2 spike protein (aa 47-716), full-length SARS-CoV-2 nucleoprotein (N) fused to a highly conserved portion of the SARS-CoV-2 polymerase (RdRp or POL).
16405919|NCT05094596|Drug|Standart treatment group|Group 1 (n=60) received standard treatment in accordance with our national COVID-19 diagnosis and treatment guide.
16405920|NCT05094596|Drug|Montelukast sodium 10 mg treatment|Group 2 (n=60) received 10 mg/day oral montelukast in addition to standard treatment
16405921|NCT05094596|Drug|Montelukast sodium 20 mg treatment|Group 3 (n=60) were given 20 mg/day oral montelukast in addition to standard treatment.
16405922|NCT05094583|Behavioral|Use of SmokeFree app|Intervention Arm
16405923|NCT05094570|Drug|Dupilumab Prefilled Syringe|Dupilumab 200 mg
16405924|NCT05094557|Behavioral|Experimental Group 1: Enhanced VR intervention with body swapping + psychoeducational video + Treatment As usual|The patient will be embodied in his/her own avatar and will maintain a conversation with a counsellor's avatar of his/her choice. Once the experiment starts, the patient, embodied in his/her own body, will start describing his/her problem in terms of subjective experiences of being obese in daily life. Then, he/she will be body swapped to the counsellor's body and try to respond to the problem just manifested by the patient. The crucial aspect here is that the patient, from the counsellor's viewpoint, will see a representation of his/her real body when looking at the patient's avatar speaking and moving. Therefore, the patient will have the opportunity to see himself/herself in first person (1PP) and second person (2PP) perspectives.
16405925|NCT05094557|Behavioral|Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual|"Participants from the Experimental Group 2 will be embodied in their own body and will participate in a scripted dialogue with the chosen counsellor that will ask about the perceived barriers for engagement with a healthier lifestyle and will give practical recommendations about how to achieve a healthier and happier life, in terms of healthy eating and physical activity. No body swapping will take place for this group. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle."
16405926|NCT05094557|Behavioral|Control Group: Psychoeducational video + Treatment As usual|Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d´ Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.
16405927|NCT05094544|Radiation|Non-ablative SBRT|Non-ablative SBRT (800 cGy X 3 fractions) given 5-7 days preoperatively in selected patients with stage I-II NSCLC
16405928|NCT05094531|Other|Primary prevention programm|This programm aims to adress three dimensions : (i) biophysiology (flexibility of the autonomic nervous system), (ii) psychology (flexibility of coping strategies, sens of mission) and (iii) the social (stigmatization, seeking health care).
16405929|NCT05094518|Behavioral|Mobile phone reminders|Appointment reminders in the form of push notifications will be sent through HERA app.
16405934|NCT05094492|Combination Product|Curodont Repair Fluoride Plus|P11-4 self assembling peptide combined with fluoride
16405935|NCT05094492|Other|Bifluorid 10 fluoride varnish|5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)
16405936|NCT05094479|Behavioral|Health information delivered via health app|Intervention group will use a health app with non-personalized information on health-promoting lifestyle habits during pregnancy. Control group will use a health app without health information. Intervention effects on the lifestyle habits (gestational weight gain, diet quality, physical activity) will be investigated.
16405937|NCT05094466|Behavioral|Behavioral Intervention|Receive peer support sessions
16405938|NCT05094466|Other|Counseling|Receive health coaching sessions
16405939|NCT05094466|Procedure|Discussion|Attend focus groups
16405940|NCT05094466|Other|Educational Intervention|Receive handbook
16405941|NCT05094466|Other|Informational Intervention|Receive navigation sessions
16405942|NCT05094466|Other|Interview|Participate in interview
16405943|NCT05094440|Behavioral|Dialectical behavioral therapy skills training (DBT-ST)|Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur over eight weeks and will be supplemented with a weekly guide and links to DBT worksheets.
16406872|NCT04430036|Drug|Gemcitabine|Antimetabolite antineoplastic agent
16405944|NCT05094427|Procedure|Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon|Patients received bupivicaine injections delivered via 22-gauge spinal needle to the junction of the facet and transverse process or ala at multiple spinal levels (2.5-5 cc per injection of 0.25% or 0.5% bupivacaine).
16405945|NCT05094414|Drug|Valacyclovir|oral valacyclovir 500 mg twice per day for 4 weeks
16405946|NCT05094401|Device|BT-001|BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
16405947|NCT05094388|Other|Admitted to intensive care units|Admitted to intensive care units
16405948|NCT05094375|Drug|Vaginal Misoprostol 600 mcg|"All patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 600 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
~Two doses of misoprostol 600 mcg each (3 tablets of 200 mcg per dose).
~Paracetamol, eight hourlies, will be provided as analgesic or antipyretic.
~A specimen bottle to collect the POC if passed out.
~Two pairs of disposable gloves.
~Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception"
16405949|NCT05094375|Drug|Vaginal Misoprostol 800 mcg|"All patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
~Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
~Paracetamol, eight hourlies, will be provided as analgesic or antipyretic.
~A specimen bottle to collect the POC if passed out.
~Two pairs of disposable gloves.
~Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception"
16405950|NCT05094362|Behavioral|Spinal Reflex Operant Down Conditioning|This is a training intervention in which people with a spinal cord injury are trained to reduce the activity of a certain spinal reflex. By decreasing this reflex, individuals decrease hyperactivity in the reflex and can reduce spasticity.
16405951|NCT05094336|Drug|AMG 193|AMG 193: Orally via tablet
16405952|NCT05094336|Drug|Docetaxel|Docetaxel: Intravenous infusion
16405953|NCT05094323|Drug|Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine|Patients will receive ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine.
16405954|NCT05094323|Drug|Local wound infiltration with isobaric bupivacaine|Patients will receive local wound infiltration with isobaric bupivacaine.
16405955|NCT05094323|Drug|Ultrasound-guided thoracic paravertebral block with isobaric bupivacaine|Patients will receive ultrasound-guided thoracic paravertebral block with isobaric bupivacaine.
16405956|NCT05094310|Device|Acupuncture|Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire. Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study，and those patients will receive acupuncture treatment. The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine. According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month. We collected patients' blood to detect fatigue related SNP.
16405957|NCT05094297|Behavioral|Investigate the effects of an exercise intervention on U.S. Veterans.|Enrolled subjects will be asked to complete 94 total visits (4 study testing visits and 90 exercise visits). They will be tested for fitness, strength, and health risk factors at UIC 4 times and will complete 90 exercise training visits at the GH FITLab over the next 18 months.
16405958|NCT05094284|Device|BioFreedom Ultra|this is a registry only
16405959|NCT05094271|Other|Supplemental Oxygen|Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings.
16405960|NCT05094271|Device|Continuous Positive Airway Pressure Machine|Continuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.
16405961|NCT05094271|Other|Room Air|Subjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings.
16405962|NCT05094258|Procedure|unicondylar knee prosthesis with mobile insert|Patients with unicondylar knee replacement using the mobile insert option
16405963|NCT05094258|Procedure|unicondylar knee prosthesis with fixed insert|Patients with unicondylar knee replacement using the fixed insert option
16405964|NCT05094245|Procedure|Stellate Ganglion Block Group|Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.
16405965|NCT05094219|Other|No intervention will be offered|No intervention will be offered
16405966|NCT05094206|Biological|CAR20.19.22 cells 0.75x10^6 cells/kg|CAR20.19.22 cells will be administered either fresh or thawed after cryopreservation by IV injection.
16405967|NCT05094206|Biological|CAR20.19.22 cells 1x10^6 cells/kg|CAR20.19.22 cells will be administered either fresh or thawed after cryopreservation by IV injection.
16405968|NCT05094206|Biological|CAR20.19.22 cells 2.5x10^6 cells/kg|CAR20.19.22 cells will be administered either fresh or thawed after cryopreservation by IV injection.
16405969|NCT05094193|Procedure|Trocar-site infiltration|20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)
16405970|NCT05094193|Procedure|TAP block|bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side
16405971|NCT05094193|Procedure|Trocar site infiltration placebo|20 mL of normal saline
16405973|NCT05094180|Other|Face-to-face appointment|Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).
16405974|NCT05094180|Other|Teleconsultation|Participants allocated in the teleconsultation arm will be scheduled phone call visits (i.e., date and time slot in which the physician will contact). The physician will call the main phone number provided by the patient and, in case of not receiving an answer, other phone numbers listed as contact numbers. Participants allocated in the teleconsultation arm cannot be visited by video.
16405975|NCT05094180|Other|Video consultation|Participants allocated in the video consultation arm will be provided with an app, which can be installed in mobile phone, for safe videoconference. At the moment of the videoconsultation, the patient will be provided with a link to the meeting through the video conference app. Patients will remain in the virtual waiting room until the physician starts the visit. Participants allocated in video consultation arm can undergo up to 25% of phone visits in case of failure of the videoconferencing system.
16405976|NCT05094167|Other|V9|one times a day during the whole treatment
16405977|NCT05094167|Other|placebo|placebo
16405978|NCT05094154|Drug|anti-pseudomonal cephalosporin|Providers will be prompted to order an anti-pseudomonal cephalosporin, such as cefepime with a dose range of 500 mg, 1,000 mg, or 2,000 mg, and frequency every 6, 8, 12, or 24 hours based on provider discretion.
16405979|NCT05094154|Drug|anti-pseudomonal penicillin|Providers will be prompted to order anti-pseudomonal penicillin, such as piperacillin-tazobactam with a dose range of 3.375 g or 4.5 g and frequency every 6, 8, or 12 hours based on provider discretion.
16405980|NCT05094141|Other|Virtual reality|Virtual reality game
16405981|NCT05094128|Drug|Upadacitinib|Tablet; Oral
16405982|NCT05094115|Behavioral|Psychological Flexibility Training (PFT)|"A 2-day workshop lasting approximately 8 hours per day. Day 1: an overview of the training and to describe the posture or stance that prepares one to respond to challenging situations in a psychologically flexible manner.
~Day 2: identifies common coping strategies that typically fail or even backfire over the long term and to practice skills that promote psychological flexibility. Experiential exercises will be integrated throughout the training.
~Following the PFT, 4 optional, monthly, one-hour booster sessions to supply refresher information.
~An experiential exercise to highlight one or more process/concept that was introduced during the 2-day training.
~Questions from the attendees about applying the concepts in their lives.
~Comments and questions from the booster session facilitators to encourage application of the concepts."
16405983|NCT05094102|Device|OnLume Imaging System|for fluorescence-guided surgery with ICG dye
16405984|NCT05094102|Drug|Indocyanine green|Indocyanine green is a cyanine dye used in medical diagnostics
16405985|NCT05094089|Device|Hernia repair with mesh|Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
16405986|NCT05094076|Radiation|chest x ray|The chest radiographs obtained will be classiﬁed according to the International Labor Organization (ILO) System for Classiﬁcation of Radiographs for Pneumoconiosis [ILO, 1980]. Film quality, profusion, and shape and size of opacities will be evaluated by this method. Radiographic evidence of silicosis was deﬁned as a profusion score of 1/0 or greater
16405987|NCT05094063|Other|patient education by mobile application|Training will be given to the patients in the experimental group.
16405988|NCT05094050|Drug|ABBV-951|Continuous Subcutaneous Infusion (CSCI)
16405989|NCT05094037|Device|Removable cam walker boot|Standard of care device given to diabetic foot ulcer patients.
16405990|NCT05094037|Other|Counseling|Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.
16405991|NCT05094024|Dietary Supplement|Central kitchen-prepared version of MDCF-2|Kitchen-prepared MDCF-2 containing chickpea flour, peanut flour, soybean flour, green banana pulp, sugar, soybean oil and micronutrient mix. This version of MDCF-2 will be freshly prepared in central kitchens on a daily basis and provided to participants on the same day. Every child in this arm will be offered 25g of the MDCF-2 formulation twice daily.
16405992|NCT05094024|Dietary Supplement|MDCF-2 shelf-stable foil pouch prototype with green banana powder|This shelf-stable foil pouch prototype of MDCF-2 contains chickpea flour, peanut flour, soybean flour, green banana powder, sugar, soybean oil and micronutrient mix, prepared by an industry partner following the formulation developed at icddr,b. Every child in this arm will be offered 25g of the formulation twice daily.
16405993|NCT05094024|Dietary Supplement|MDCF-2 shelf-stable foil pouch prototype with sweet potato|This shelf-stable MDCF prototype contains chickpea flour, peanut flour, soybean flour, sweet potato, sugar, soybean oil and micronutrient mix. This version of MDCF-2 will be prepared by an industry partner following the formulation developed at icddr,b. Every child in this arm will be offered 25g of the MDCF formulation twice daily.
16405994|NCT05094024|Dietary Supplement|Freshly reconstituted MDCF-2 ingredients|This version of MDCF-2 is comprised of its individually packaged ingredients. Separate premeasured sachets of chickpea flour, peanut paste, soybean flour, green banana powder, sugar, soybean oil and micronutrient mix will be combined and reconstituted prior to each feeding session. Every child in this arm will be offered 25g of the formulation twice daily.
16405995|NCT05094024|Dietary Supplement|Ready-to-use supplementary food (RUSF) arm|Locally-produced ready-to-use supplementary food (RUSF) is used as part of a nutritional program to treat moderate acute malnutrition in children over 6 months-of-age. RUSF is eaten directly from the package with no dilution, mixing or cooking. RUSF contains rice, lentil, powdered low-fat milk, soybean flour, sugar, and micronutrient mix. Every child in this arm will be offered 25g of the formulation twice daily.
16405996|NCT05094011|Biological|Aadipose-Derived Mesenchymal Stem Cells|Stereotactic intrastriatal implantation of 3×10^7 per hemisphere (total 6×10^7 cells) or 1×10^8 per hemisphere (total 2×10^8 cells) autologous TM01-treated adipose-derived mesenchymal stem cells (MitoCell).
16405997|NCT05093998|Drug|AV5080|oral hard gelatin capsules
16405998|NCT05093998|Other|Placebo|Hard gelatin capsules with a white body
16405999|NCT05093985|Other|Neuromuscular electrical stimulation with blood flow restriction|Neuromuscular electrical stimulation with blood flow restriction
16406000|NCT05093972|Drug|MK-8507|Four MK-8507 100 mg tablets (total dose 400 mg) taken by mouth.
16406002|NCT05093959|Drug|Placebo|Placebo is a biologically inert substance placed in capsules to match appearance of active intervention
16406003|NCT05093933|Drug|Vericiguat|2.5, 5.0, or 10.0 mg orally once daily
16406004|NCT05093933|Drug|Placebo|0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat
16406005|NCT05093920|Drug|Doxorubicin-Eluting Beads|"The patients will be categorized in two randomized groups; c-TACE group (A) and DEB-TACE group (B).
~After patient counseling and obtaining a written consent to participate in the study, both groups will be subjected to the interventional procedure according to patient group; Group A; Lipidol-Doxorubicin emulsion material followed by gel foam embolic material will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.
~Group B; Doxorubicin-Eluting Beads will be injected through the catheter directly into tumor feeding vessels through transarterial catheter."
16406006|NCT05093907|Drug|BEY1107|Administer once daily, PO, 3-week continuous dose.
16406007|NCT05093907|Combination Product|Capecitabine|Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.
16406008|NCT05093894|Device|Group 1|Microlyte will be cut into strips and placed on the subcutaneous space
16406009|NCT05093881|Biological|Cellgram-LC|Patients who had administered Cellgram-LC in PMC-P-07 study
16406010|NCT05093868|Device|Electrographic Flow Mapping|Electrographic Flow Mapping will be collected
16406011|NCT05093855|Drug|BDB-001 Injection|Single IV infusions of BDB-001 Injection diluted in sodium chloride
16406014|NCT05093829|Biological|NmCV-5|NmCV-5 is a pentavalent meningococcal (A, C, Y, W, X) polysaccharideconjugate vaccine composed of capsularpolysaccharides (PS) from Neisseria meningitidis serogroups A, C, Y, W, and X individually conjugated to a protein carrier, either mutant diphtheria toxoid (CRM197) or tetanus toxoid (TT).
16406015|NCT05093829|Biological|MenACWY-TT|MenACWY-TT (the comparator meningococcal vaccine) is a WHO-PQ quadrivalent meningococcal (A, C, Y, W) polysaccharide-conjugate vaccine manufactured by Pfizer.
16406017|NCT05093803|Behavioral|CONTROL GROUP|Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
16406018|NCT05093803|Behavioral|HEALTH APP GROUP|"Use of a mobile application based on machine learning with the aim of improving health parameters and body composition.
~Specific diet program and moderate physical activity, all guided and mediated by a mobile application. As well as the recording and monitoring of periodic evaluations of health indicators."
16406019|NCT05093790|Drug|Ticagrelor|Specified dose on specified days
16406020|NCT05093790|Drug|BMS-986141|Specified dose on specified days
16406021|NCT05093790|Drug|Aspirin|Specified dose on specified days
16406022|NCT05093777|Other|Program Intensified Habilitation|The program is based on a holistic and family-centered concept, which acknowledges parents as experts on their child's abilities and needs. The program involves both parents and local professionals, and includes goal setting and goal-directed treatment targeted to the needs of the individual child. The program lasts for about one year and contains three in-patient group sessions over 2 weeks. In between the children are receiving individualized home training programs at home and in pre-school/kindergarten. The children train on a daily basis, both during the inpatient sessions and in the home setting.
16406023|NCT05093777|Other|Habilitation as usual|"When the participants are not joining the study year containing the intervention program, they will be offered habilitation services as usual administered by the primary health care services in the local community."
16406024|NCT05093764|Device|VIV TAVR with BVF using TCEP|The insertion and retrieval of the SENTINEL device is performed at the time of the patients TAVR procedure in the same setting while they are sedated under moderate sedation or general anesthesia depending on the case. The device is inserted at the initiation of the procedure through 6F right radial artery access and the filters are positioned in the left common carotid artery and brachiocephalic artery. After deployment, the usual TAVR procedure is performed. At the conclusion of the procedure, the SENTINEL device is extracted and hemostasis is achieved at the radial access site in the usual fashion with patent hemostasis.
16406025|NCT05093751|Other|Observation|This study does not involve any intervention to subjects.
16406026|NCT05093738|Other|Cognitive Rehabilitation|In the content of the person-centered intervention program, attention, memory, orientation, praxis (motor planning) training; metacognition (metacognition) training; visual perception; There will be cognitive training for executive functions. The intervention will consist of play activities (games, computer-assisted games) for cognitive skills; The games will be applied in a way that suits the child from simple to complex. Visual perception applications (designing blocks, recognizing and sorting the shapes in the picture, matching opposite shapes etc.); attention practices, memory practices, strategy development, space-time orientation, motor planning, games and metacognitive strategies aimed at developing skills such as planning, organization, working memory, impulse control, time management and awareness, abstract thinking, cognitive flexibility will form our intervention program.
16406027|NCT05093725|Device|flow cytomery|take sample of Wharton jelly and culturing it to know the best time for mesenchymal stem cell growth
16406028|NCT05093712|Other|Educational Intervention|Watch educational video
16406029|NCT05093712|Other|Survey Administration|Complete surveys
16406030|NCT05093699|Device|Butterfly iQ+ ultrasound probe|Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing
16406031|NCT05093699|Device|Ultrasound probe|Standard single-view ultrasound probe
16406062|NCT05093465|Behavioral|Technology Intervention|"Participants were provided with sleep hygiene and stimulus control procedure plus procedures to reduce technology usage in bed (i.e., technology usage stimulus control).
~In addition to the sleep hygiene and stimulus control procedures, participants were also given a set of procedures aimed at changing technology usage behavior at bedtime and throughout the day."
16406032|NCT05093686|Behavioral|RUBIES|RUBIES is an 8 module intervention that begins with foundational education on ASD (Session1), followed by introducing basic applied behavior analysis principles (Session 2). Instruction is then provided on strategies that can prevent problematic behaviors from occurring (Session 3 and 4). Reinforcement (Session 5) reviews the use of tangible and social reinforcers tools to promote new/desired behaviors while planned ignoring and functional communication training (Session 6) teaches that disruptive behavior can serve as a form of communication while ignoring disruptive communicative attempts. Sessions conclude with instruction on effective ways to deliver commands to promote compliance (Session 7) and targeting approaches to ensure positive behavior gains can maintain over time and strategies can be used across classrooms and staff (Session 8).
16406033|NCT05093686|Behavioral|Usual Care Training|Usual Care Training is an 8 module psychoeducation program that will provide foundational information on autism spectrum disorders, including the diagnostic criteria, appropriate educational services, common interventions, and how to promote social skills in the classroom.
16406034|NCT05093673|Device|Cathodal Cerebellar tDCS|2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes.
16406035|NCT05093673|Behavioral|Semantic Feature Analysis (SFA)|Semantic Feature Analysis (SFA) is a treatment technique designed to improve lexical retrieval by increasing the level of activation within a semantic network. The treatment will proceed according to a series of steps including naming aloud the target picture, generating semantic features, naming aloud the target picture again, and generating a sentence using the target word.
16406036|NCT05093673|Device|Sham|2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
16406037|NCT05093660|Diagnostic Test|Blood specimen collection|Blood specimen collection for analysis of CRP (C-reactive protein), WBC (White blood cells) and LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels
16406038|NCT05093660|Diagnostic Test|Saliva specimen collection|Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels
16406039|NCT05093634|Drug|Setmelanotide|Subcutaneous Injection
16406040|NCT05093634|Drug|Placebo|Subcutaneous Injection
16406041|NCT05093621|Drug|Furosemide|Standard of care diuretic
16406042|NCT05093621|Drug|Torsemide|Standard of care diuretic
16406043|NCT05093608|Drug|Selinexor Pill|Selinexor 60 mg or 80 mg (oral table) will be administered once a week.
16406044|NCT05093608|Drug|Bevacizumab|Bevacizumab will be administered at a standard dose of 15 mg/kg every 3 weeks.
16406045|NCT05093608|Drug|Atezolizumab|Atezolizumab will be administered intravenously a standard dose of 12,000 mg every 3 weeks.
16406046|NCT05093595|Device|SFC|The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .
16406047|NCT05093582|Drug|Levcromakalim|12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least one week in between.
16406048|NCT05093582|Drug|Saline|12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least one week in between.
16406049|NCT05093569|Device|K'watch|Patients
16406051|NCT05093543|Behavioral|physical rehabilitation/physiotherapy and psychosocial group sessions|physical rehabilitation/physiotherapy and psychosocial group sessions
16406052|NCT05093530|Drug|Neumifil|Neumifil contains the active ingredient HEX17, a multivalent, glycan-targeting carbohydrate binding module (CBM). HEX17 CBM is suspended in an aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.
16406053|NCT05093530|Drug|Placebo|Aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.
16406054|NCT05093517|Drug|REMD-477|A biologic glucagon receptor agonist to which randomized subjects are assigned 2:1
16406055|NCT05093517|Drug|Placebo Subcutaneous injection|Placebo for REMD-477 to which subjects will be randomized 1:2.
16406056|NCT05093504|Device|Sham comparator|Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
16406057|NCT05093504|Device|DrugSorb-ATR system|Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
16406058|NCT05093491|Diagnostic Test|Spirometry and ultrasonography in stroke group|Ultrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio in the supine position in the stroke patient group. The spirometric evaluation was also performed
16406059|NCT05093491|Diagnostic Test|Spirometry and ultrasonography in healthy group|Ultrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio in the supine position in healthy individuals group. The spirometric evaluation was also performed
16406060|NCT05093478|Drug|Intranasal capsaicin|Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.
16406061|NCT05093478|Drug|topical lidocaine|The nose will be pre-treated with topical lidocaine 15 minutes before each application
16406063|NCT05093465|Other|Active Control|Participants were provided with sleep hygiene and stimulus control procedures.
16406097|NCT05093218|Other|placebo|Placebo will have the similar colour, taste and consistency. Both groups will be given the same dose.
16406098|NCT05093205|Drug|PF-06882961|Tablets
16406064|NCT05093452|Behavioral|Motivational Interviewing|Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a midwife. The midwife will have first received a standardized 3 days training session on the content and techniques of MI. The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes.
16406065|NCT05093452|Other|Information flyer|Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the midwife.
16406066|NCT05093439|Diagnostic Test|Heart Rate Variability|Heart rate variability wil be calculated from patients' 10 sec ECG with a dedicated software (Kubios).
16406067|NCT05093426|Other|Stage 2 Digital sleep diary app|Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.
16406068|NCT05093413|Behavioral|Sleep deprivation|Fully slept: Sleep habitual amount (i.e., go to sleep at habitual bedtime and wake up at habitual wake time) Sleep deprived: Reduce sleep by 50% (i.e., go to sleep at habitual bedtime and wake up early)
16406069|NCT05093400|Other|no intervention|saliva collection
16406070|NCT05093387|Drug|Carboplatin|Given IV
16406071|NCT05093387|Biological|Pembrolizumab|Given IV
16406072|NCT05093387|Genetic|Transferrin Receptor-Targeted Liposomal p53 cDNA|Given IV
16406073|NCT05093374|Drug|anti-VEGF agent|"All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented.
~Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator. Should the Investigators decision differ from the study protocol, the reason will be indicated in the CRF."
16406074|NCT05093374|Drug|anti-VEGF agent|"All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented.
~In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment."
16406075|NCT05093361|Procedure|Total Hip Arthroplasty|Total Hip Arthroplasty for the treatment of hip arthritis.
16406076|NCT05093361|Procedure|Physical Therapy|Self-driven training according to the training plan instructed by physical therapist.
16406077|NCT05093348|Device|Click2Print artificial eye|Digitally designed and manufactured ocular prosthesis
16406078|NCT05093348|Device|Hand-made artificial eye|Hand-made artificial eye
16406079|NCT05093335|Drug|[68Ga]-Pentixafor|An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants.
16406080|NCT05093322|Drug|Surufatinib in combination with Gemcitabine|Surufatinib in combination with Gemcitabine
16406081|NCT05093309|Behavioral|Educational Webinar|At month 1 of the study period, the educational webinar was presented by expert speakers and consisted of 3 modules: 1) naloxone basics; 2) naloxone service implementation strategies; and 3) naloxone recommendation communication strategies. Participants were mailed naloxone nasal spray and auto-injector training devices prior to attending the online webinar so that they could follow along during demonstrations.
16406082|NCT05093309|Behavioral|Resources|After completing the baseline survey, both control and intervention groups were provided with a basic publicly available flyer about naloxone dosage forms in order to ensure all participants could provide adequate patient care.
16406083|NCT05093309|Behavioral|Reminders|Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
16406084|NCT05093296|Drug|Oxytocin nasal spray|24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.
16406085|NCT05093296|Drug|Naltrexone Pill|All participants will receive 50mg Naltrexone daily as oral tablet throughout the study
16406086|NCT05093296|Drug|Placebo|Placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)
16406087|NCT05093283|Device|Virtual Reality Glasses|Virtual Reality Glasses
16406088|NCT05093270|Drug|BGB-23339|Administered orally as a tablet
16406089|NCT05093270|Drug|Placebo|Administered orally as a tablet
16406090|NCT05093257|Diagnostic Test|Laboratory investigations for control|"Complete blood picture .
~Erythrocyte sedimentation rate(ESR).
~Liver function tests .
~Kidney function tests.
~CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry"
16406091|NCT05093257|Diagnostic Test|Laboratory investigations for patients|"Complete blood picture .
~Erythrocyte sedimentation rate(ESR).
~Liver function tests .
~Kidney function tests.
~Anti-nuclear antibodies test by immunoflourescence for ITP patients.
~Bone marrow aspiration (for diagnosis of ITP).
~CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry."
16406092|NCT05093244|Device|SeQuent Please ReX|The SeQuent Please ReX is a conventional rapid exchange balloon tip catheter with a drug-coated balloon (DCB). The surface of the SeQuent Please ReX balloon is coated with paclitaxel, embedded in a soluble matrix (resveratrol).
16406093|NCT05093244|Device|Plain old balloon angioplasty (POBA)|Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.
16406094|NCT05093231|Drug|Pembrolizumab|Pembrolizumab is a highly selective immunoglobulin G4-kappa humanised monoclonal antibody against Programmed cell death protein 1 (PD-1) receptor. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype with the containing a stabilizing Serine 228 to Proline Fc mutation.
16406095|NCT05093231|Drug|Olaparib|Olaparib is a potent inhibitor of polyadenosine 5'diphosphoribose polymerase (PARP) developed as a monotherapy as well as for combination with chemotherapy, ionising radiation and other anti-cancer agents including novel agents and immunotherapy.
16406096|NCT05093218|Dietary Supplement|branch chain amino acid|• Branch chain amino acid at a dose of approxiametely 0.35g/kg will be supplemented in two divided doses group for a period of 12 weeks.For the sake of administration, it will be prescribed as per the following weight band categories: <5kg 2 gm 5-10kg 4 gm 10-20kg 8 gm 20-40kg 12 gm 40-60kg 24 gm
16406099|NCT05093205|Drug|Atorvastatin|Tablets
16406104|NCT05093140|Drug|Camrelizumab|"Induction therapy:
~Camrelizumab 200mg, ivd, D1, Rituximab 375mg/m2, ivd, D1 every 3 weeks up to 2 cycles
~Immunochemotherapy:
~Rituximab: 375mg/m2, ivd, D1; Cyclophosphamide: 750mg/m2, iv or ivd, D1; Hydroxyldaunorubicin: 50mg/m2, iv or ivd, D1; Vincristine: 1.4 mg/m2 , iv(max：2mg), D1; Prednisone: 60mg/m2, po, d1-5 every 3 weeks up to 6 cycles Maintenance therapy: Camrelizumab 200mg, ivd, D1 every 4 weeks up to 6 cycles"
16406105|NCT05093127|Device|Carotid Artery Stenting|R-OneTM system is a tool available to physicians for performing CAS without changing the treatment of the pathology. R-OneTM system is designed to remotely deliver and manipulate guidewires and stent/balloon devices during Carotid Artery Stenting. The system is composed of the R-OneTM robotic platform used in combination with two accessories, the Mobile radioprotection screen and a sterile and single-use R-OneTM consumable kit. The physician, seated at the remote radio-protected control station, manipulates guidewires and/or balloon/stent catheters using joysticks on the Command unit.
16406106|NCT05093101|Other|case series review of clinical data|Extraction of pre-surgical and chemotherapy blood test laboratory data and clinical and instrumental data related to patient history from digitized medical records and analysis
16406107|NCT05093075|Other|Therapeutic Plasma Exchange|TPE procedures will be performed using a Spectra Optia ® apheresis machine (Terumo BCT, Lakewood, USA) according to usual-care procedures for apheresis. Venous access for the TPE procedures will be obtained through a double lumen dialysis catheter to provide adequate flow rates required for TPE. Regional citrate anticoagulation will be used for anticoagulation within the apheresis circuit. One to two grams of calcium chloride will be infused as per standard during TPE to prevent symptomatic hypocalcemia. Plasma volume will be calculated as per a standard formula whereby estimated plasma volume (in liters) = 0.07 x weight (kg) x (1 - hematocrit). In patients on dialysis, dialysis will be interrupted for the duration of the procedure. Antibiotics will be given after TPE to avoid clearance of the antibiotics. On the first day of TPE, a repeat dose of antibiotics will be administered after completion of TPE. Nurse clinicians trained in TPE will perform the TPE procedures.
16406108|NCT05093062|Other|Tian Jiu Therapy|
16406109|NCT05093049|Device|Renuvion APR System|The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.
16406110|NCT05093036|Other|Variations in PrEP care delivery at public health services|Variations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring
16406111|NCT05093023|Genetic|Real-Time PCR|Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G>A and 3435 G>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol.
16406112|NCT05092997|Diagnostic Test|POC viral load testing|POC viral load testing- women randomized to have POC VL at enrollment, delivery and 6 months post-partum, will have a finger prick to obtain whole blood for the Cepheid Xpert HIV-1 RNA cartridge on the Xpert IV machine with results in 90 minutes. Women who are randomized to POC VL who have VL >200 c/ml will receive additional adherence counseling, following the STREAM protocol, [26] to address the challenges that they are having with ART use. At the delivery visit, infants of women in the POC VL arm will also have viral load testing done.
16406113|NCT05092997|Other|Wellness visit services for male partners|Wellness visits for men- additional prevention services for men randomized to the intervention arm, including dual syphilis and HIV testing, blood pressure, visual acuity screening, and COVID-19 screening as part of wellness
16406114|NCT05092984|Drug|Spironolactone|"77 patients will be treated with spironolactone Mylan 25mg/day for the first 3 months of the study. Dosage adjustment can be performed according to the eGFR (estimated Glomerular Filtration Rate) concentration at baseline and the serum potassium variation.
~During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation."
16406115|NCT05092984|Drug|Placebo|"77 patients will be treated with placebo 25mg/day for the first 3 months. At inclusion, a second randomization is automatically performed in the placebo arm to determine patients receiving a dose adjustment during the study to keep the double-blind.
~During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation."
16406118|NCT05092958|Drug|Avelumab|Given IV
16406119|NCT05092958|Drug|Cabozantinib S-malate|Given PO
16406120|NCT05092958|Other|Quality-of-Life Assessment|Ancillary studies
16406121|NCT05092958|Other|Questionnaire Administration|Ancillary studies
16406122|NCT05092945|Other|Cold exposure|The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
16406123|NCT05092945|Drug|Oral Nicotinic acid|A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg: one dose of 150 mg at time 0 and 60 minutes, one dose of 100 mg at time 120 minutes and 180 minutes.
16406124|NCT05092932|Other|Normal Foot Force|LoadSol Insoles will be inserted into the participants shoes. The device measures the pressure distribution on the bottom of the foot. Participants will then be asked to walk normally, use crutches, use a walker, and use a wheeled knee scooter. The pressure placed throughout the foot will be analyzed and compared under different conditions. This testing will take approximately 10 minutes.
16406125|NCT05092919|Other|Flavor|Sweet flavored vs. non-flavored cigarillos.
16406126|NCT05092906|Other|LP with complementary hypnoanalgesia|The lumbar puncture technique will be identical to that of the group standard of care. Hypnosis will be performed by a health professional trained in this practice, in addition to the standard analgesic management.
16406175|NCT05082649|Other|Face to Face Exercise|Face to face (in clinic) progressive spinal stabilization exercises.
16406949|NCT04316117|Other|Fludeoxyglucose F-18|Given IV
16406127|NCT05092906|Other|LP with standard of care|"The LP will be carried out according to the usual techniques without hypnosis.
~Standard analgesic treatments will be used (except contraindications):
~EMLA (Lidocain+Prilocain) Cream/Patch
~Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable
~Nitrous oxide"
16406128|NCT05092893|Other|Online parental questionnaires|"The SRS-2 is a parental 65-item questionnaire to detect difficulties in social responsiveness in children with autism spectrum disorder. Four different forms are available: preschoolers (2.5-4.5 years), school-aged children (4-18 years), adults (≥ 19 years) and adults self-report. In this study, only the form for school-aged children will be used.
~The DCDQ'07 is a parental 15-item questionnaire to detect the risk of DCD in children between 5 and 15 years of age. Parents are asked to compare their child's motor performance to his/her peers using a 5-point Likert scale. The total sum score is compared to age-specific cut-off scores to determine the risk of DCD. Belgian norms are available since 2007."
16406129|NCT05092880|Device|radioembolization|holmium-166 microspheres
16406130|NCT05092867|Other|Po Tra tool|Healthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational)
16406131|NCT05092854|Other|PR Lotion - AMP Human Performance|"Sodium Bicarbonate Topical Solution. For use of the PR Lotion solution, consumers are instructed to apply the lotion to areas of the body that have been identified as most likely to use during their activity (i.e. calves and thighs for runners, shoulders and forearms for swimmers, etc.). Moreover, the product can be applied up to 2 hours prior to beginning a workout or event with one use supporting a 4-6 hour workout. AMP Human has also verified the safety of their product as being well tolerated in consumers >2 years of age unless there is a known allergy to an ingredient on the label. Moreover, to the company's knowledge no side effects have been reported per the SAFETY Section at https://amphuman.com/pages/faq.
~Other Names:
~NDC Code: 72358-101-01 NDC Code: 72358-101-02 NDC Code: 72358-101-03"
16406132|NCT05092854|Other|Placebo Lotion|Placebo Topical Solution. Lotion will be created by the AMP Human Performance company and will include all ingredients similar to the PR Lotion product except for the exclusion of sodium bicarbonate.
16406133|NCT05092854|Other|AminoVital - Rapid Recovery|AminoVITAL Rapid Recovery is a commercially available supplement that is not currently regulated by the FDA but does complete both internal quality control and third-party testing for all of their products. AminoVITAL Rapid Recovery has been certified by the Banned Substance Control Group (BSCG; https://www.bscg.org/certified-drug- free-supplements/?AminoVITAL) and has been certified to be free of 496+ drugs including WADA Prohibited Substances as well as prescription, over the counter, and illicit drugs not banned in sport. AminoVITAL Rapid Recovery is safe to consume multiple times within a single day and has been found most effective when taken within 30 minutes of cessation of exercise. No known side effects are associated with the ingestion of aminoVITAL Rapid Recovery; however, side effects of amino acid toxicity include gastrointestinal distress, nausea and headache.
16406134|NCT05092854|Other|Placebo Supplement|Supplement will be created by the aminoVITAL company and will include all ingredients similar to the commercially available Rapid Recovery product except for the exclusion of the amino acid blend.
16406135|NCT05092841|Drug|PXT3003|Patients will be administered PXT3003 twice daily (bid) at 10mL.
16406136|NCT05092841|Drug|PXT3003 placebo|Patients will be administered PXT3003 placebo twice daily (bid) at 10mL.
16406139|NCT05092815|Drug|HLX208|HLX208 450mg bid po
16406140|NCT05092802|Drug|HLX208|450mg bid po
16406141|NCT05092789|Other|Kinesio taping group|"Participants in this group will receive treatment through standardised therapeutic kinesio taping along with conventional therapy.
~Tape will place over the posterior cervical extensor muscle, from insertion to the origin, with the patient's neck in cervical contralateral side-bending and rotation.
~Duration of kinesio tape will be of 48 hours with 50-100% tension.
~Participants of this group will also receive conventional therapy which will include:
~Hot pack for 10 minutes Stretching exercises of the neck muscles. This protocol is for 6 weeks. The sessions will be given twice a week making it a total of 12 sessions."
16406142|NCT05092789|Other|Cervical thrust manipulation group|"Participants of this group will receive treatment via cervical thrust manipulation along with conventional therapy.
~For mid cervical spine thrust manipulation, the patient will be in supine lying position,with cervical spine in neutral position.
~The therapist will cradle the patients head with the other hand. Gentle ipsilateral cervical side flexion and contralateral rotation will introduce until tension will perceive in target tissues at contact point. A high velocity, low amplitude thrust manipulation, will direct upward and medially in direction of subject's contralateral eye.
~Participants of this group will also receive conventional therapy which will include:
~Hot pack for 10 minutes Stretching exercises of the neck muscles. This intervention protocol is for 6 weeks. The sessions will be given twice a week making it a total of 12 sessions with 1 month follow up."
16406143|NCT05092789|Other|Conventional therapy group|"Participants of this group will receive only conventional therapy which will include:
~Hot pack for 10 minutes Stretching Exercises of neck muscles. For sternocleidomastoid stretching, the subject will ask to sit or stand facing forward, exhale and slowly turn your head to right, by keeping shoulder relaxed and down,inhale and return to the center, then turn to look at your left shoulder, ask to hold this position for 30 seconds and do 3 repetitions.
~For Trapezius stretching, patient is seated upright, therapist then passively move right ear to right shoulder.
~This study includes interventional protocol of 6 weeks. The session will be given twice a week making it a total of 12 sessions with 1 month follow up."
16406144|NCT05092776|Biological|RPH-104|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
16406145|NCT05092776|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for subcutaneous Injection), 2 mL in the 4 mL-glass vial. The placebo will contain no active pharmaceutical ingredients.
16406176|NCT05082649|Other|Telerehabilitation|Remotely (with video) progressive spinal stabilization exercises.
16406177|NCT05082480|Device|Hyaluronic acid (HA)|Hyaluronic acid (HA)
16406178|NCT05082480|Device|Saline|Saline
16406288|NCT05025787|Drug|CNTX-6970|CNTX-6970, a novel potent antagonist of CCR2 with lesser effects on CCR5, is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee
16406146|NCT05092763|Behavioral|FIT4SURGERY|The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. Patients are asked to wear the Fitbit through the entire 9-12 weeks in which they are receiving neoadjuvant chemotherapy both when asleep and when awake. Patients are taught how to understand the Fitbit outputs on the application, for example, understanding how to monitor their steps and heart rate. Caregivers are also be encouraged to assist patients. Patients are provided with information about the benefits of physical activity and effective behavior change strategies for incorporating physical activity into their daily lives. These include things such as short bouts of activity by walking around the room during commercial breaks or planning to be dropped off a short walk from a destination.
16406147|NCT05092763|Behavioral|Healthy Lifestyle Control|Participants assigned to this study arm are instructed to go about their usual activities and receive education about physical activity and a healthy lifestyle for ovarian cancer patients. They are encouraged to download the free Cancer.Net mobile app and visit the cancer.net website for educational materials related to ovarian cancer and survivorship. At the end of the 9-12 week intervention, participants in the Healthy Lifestyle group receive a Fitbit for their optional, personal use after surgery.
16406148|NCT05092750|Device|FerroTraceTM|A magnetic
16406149|NCT05092750|Drug|indocyanine green (ICG)|Given by SC injection
16406150|NCT05091853|Device|Adhesix mesh|2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
16406151|NCT05091346|Drug|E7386|E7386 tablet.
16406152|NCT05091346|Drug|Pembrolizumab|Pembrolizumab IV infusion.
16406153|NCT05091242|Drug|Clonidine|Clonidine injection 3 mcg/kg once
16406154|NCT05091242|Drug|Sodium chloride|Sodium chloride 0.9 % injection 0.2 mL/kg once
16406155|NCT05090111|Drug|ALG-055009|Single or multiple doses of ALG-055009
16406156|NCT05090111|Drug|Placebo|Single or multiple doses of Placebo
16406157|NCT05090085|Other|3M Scotchbond MultiPurpose|3 step total etch adhesive system
16406158|NCT05090085|Other|Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)|Composite Resin
16406159|NCT05090085|Other|3m ESPE etch|32% phosphoric acid
16406160|NCT05090085|Other|Dimethyl Sulfoxide|DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
16406161|NCT05089526|Drug|ketamine-lidocaine-dexmedetomidine|"In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving
~1mL/10kg/h of the aforementioned solution."
16406162|NCT05089526|Drug|fentanyl|In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.
16406163|NCT05089110|Procedure|blood sample|5 cm blood sample from COVID-19 patients
16406164|NCT05087966|Behavioral|Safety Planning Intervention with Navigation Services|A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).
16406165|NCT05086510|Procedure|Radiofrequency ablation|Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods.
16406166|NCT05086263|Device|Pico G2 4k|"On this virtual reality headset, it will be loaded with an educational virtual reality mock MRI training titled Ready Teddy. This training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Furthermore, using audio/visual cues, when the viewer moves their head too much in a MRI like setting they are reminded to stay still. Biofeedback training is aimed to mimic the experience of the MRI with real audio recordings of image acquisition, in order to adequately train the view to stay still in an MRI procedure."
16406167|NCT05084443|Dietary Supplement|Drink|Roselle and placebo drink for 6 months
16406168|NCT05083442|Device|Low Level Laser Therapy|Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section
16406169|NCT05083442|Other|Sham (placebo)|Use of sham (placebo) option
16406170|NCT05083416|Behavioral|Prolonged Nightly Fasting|Limiting daily period of food intake to 10 hours and nightly fasting period to 14 hours.
16406171|NCT05083416|Behavioral|Regular Eating pattern|Food intake not limited to a specific time during day/night.
16406172|NCT05083065|Biological|Covid-19 vaccine|"First dose or complete cycle of Comirnaty (Pfizer/BioNTech) vaccine
~First dose or complete cycle of Spikevax (Moderna) vaccine
~First dose or complete cycle of AstraZeneca/Vaxzevria vaccine
~Complete cycle of vaccination using one type of vaccine for the first dose and a different type for the second dose
~Janssen (Johnson & Johnson) vaccine (single dose)"
16406173|NCT05082935|Behavioral|Phase II Promotores de Salud|Community partners (e.g., Mexican Consulate) select events for testing and use their usual outreach methods to attract participants to the site and their event. Then, at the community partner's event, the research team holds COVID-19 testing events and the Promotores de Salud health behavior intervention is delivered by bilingual research staff. The health behavior intervention includes: 1) psychoeducation to promote hand-washing, social distancing, mask wearing if unvaccinated, and continued testing to mitigate the spread of COVID-19 and psychoeducation to address vaccine hesitancy; 2) information support and service navigation to address logistical challenges associated with testing and vaccination (e.g., scheduling health care visits, transportation, language barriers); 3) motivational interviewing to explore personal, social, and behavioral barriers to testing and vaccination, and to discuss available resources.
16406174|NCT05082935|Behavioral|Phase I Promotores de Salud Outreach|Testing events re-occur every two weeks at the same location and time, based on census density on Latinx individuals for site selection. Outreach conducted by promotores occurs to increase attendance at the testing events. Outreach is culturally responsive (e.g., culturally tailored radio announcements, social media posts, community canvassing, referral by community leaders).
16406179|NCT05081531|Radiation|Adaptive Radiotherapy|All the patients will be treated with VMAT technique in its RapidArc form. A simultaneous integrated boost (SIB) technique will be used. The GTV will encompass the tumor delineated on CT scan, adjusted for MRI and PET scans. Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week.
16406180|NCT05081115|Diagnostic Test|ABCDE-Stress Echo|Each laboratory will adopt the preferred Echo stress among physical pharmacologic or pacing stress according to guidelines recommendations. Pharmacologic testing will be with dobutamine or vasodilators (dipyridamole, adenosine or regadenoson) according to physician preferences, patients' contraindications, local availability and cost. Pacing stress can be performed with transesophageal or with external permanent pacemaker. A standardized format with the ABCDE protocol will be followedl. Step D is easy with vasodilator, less easy with dobutamine, not easy and less feasible - impossible with (peak or post) treadmill exercise. Our recommendation is to use semi-supine exercise, capturing coronary flow signal in early or intermediate stages when most flow increases and feasibility is still high. When treadmill is used, step D is skipped; if information is deemed important, a vasodilator test can be performed at 30' after the end of exercise focused on CFVR and heart rate response.
16406181|NCT05081115|Diagnostic Test|SE diastolic assessment|The diastolic assessment should be included into all exercise SE tests by measuring standard Doppler-derived mitral inflow velocity, pulsed Tissue Doppler of mitral annulus, and retrograde tricuspid gradient of tricuspid regurgitation, at intermediate load of exercise and/or 1- 2 min after the end of the exercise. We will also assess, at baseline, intermediate load (50 watts) and peak-post stress: end-diastolic left ventricular volume index; end-systolic left ventricular volume index; ejection fraction and both stroke volume and cardiac output (to assess conventional contractile reserve); mitral regurgitation and left ventricular outflow tract obstruction; pulmonary artery systolic pressure; B-lines; right ventricular free wall strain to assess the presence of right ventricular dysfunction; left atrial volume index; peak atrial longitudinal strain; and mitral inflow E velocity and mitral annulus e' tissue Doppler velocity; global longitudinal strain (GLS).
16406182|NCT05081115|Diagnostic Test|SE Right ventricular function assessment|Right ventricular function will be assessed at baseline and peak stress with variations of tricuspid annular plane systolic excursion, an index of right ventricular longitudinal function, and right ventricular fractional area change (a load-dependent index of right ventricular inlet function). To distinguish between genuine right ventricular dysfunction and/or pathological increases in pulmonary vascular load, we will combine systolic pulmonary artery pressure and right ventricular end-systolic area to calculate right ventricular end-systolic pressure-area relation. Peak systolic tricuspid annulus velocity and conventional indices of left ventricular systolic and diastolic function will also be measured at baseline and peak stress according to the standard ABCDE-FGLPR protocol. Right ventricular free wall strain combined with interventricular septum strain will be assessed. Left ventricular function, wall motion score index and E/e' at baseline and peak stress.
16406183|NCT05081115|Diagnostic Test|SE in heart donors|The examination of the heart starts with a resting transthoracic echocardiography. Exclusion criteria are: resting wall motion score index>1.0; ejection fraction <45%; diastolic dysfunction of grade 2 or more; hemodynamically significant (moderate or higher) valve regurgitation or stenosis; severe left ventricular hypertrophy (left ventricular mass index >175 g/m2). A pharmacological SE with dipyridamole (0.84 mg/kg over 6 minutes) is recommended. The diagnostic end-points are stress-induced RWMA and abnormalities in global LVCR. All images will be analyzed as per guidelines similarly to the other projects, with emphasis on wall motion score index and LVCR based on ejection fraction and force. The hearts excluded from donation for RWMA or abnormal LVCR could however be collected for heart valve preparation and evaluated by coronary angiography and by pathological examination according to local facilities.
16406186|NCT05080218|Drug|Upadacitinib|Hold UPA x 2 weeks at time of COVID booster
16406187|NCT05080218|Drug|Abatacept|Hold SQ ABA x 2 weeks at time of COVID booster
16406188|NCT05080218|Drug|Secukinumab|Hold SEC x 2 weeks at time of COVID booster
16406189|NCT05080218|Drug|Tofacitinib|Hold TOF x 2 weeks at time of COVID booster
16406190|NCT05080218|Drug|TNF Inhibitor|Hold SQ TNFi x 2 weeks at time of COVID booster
16406191|NCT05080218|Drug|Canakinumab Injection|Hold CAN TNFi x 2 weeks at time of COVID booster
16406192|NCT05080127|Combination Product|application of the allergenic food|a small amount of the allergenic fresh food will be placed on the forearm using a patch test sticker for 15 minutes. the skin reaction will be measured.
16406193|NCT05079308|Device|Peripheral sealing device for surgical mask or filtering face piece|The individuals used a Peripheral Sealing Device on a surgical mask or a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).
16406194|NCT05079308|Device|IIR Surgical mask with Filtering face piece|The individuals used a IIR surgical mask with a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).
16406196|NCT05078606|Device|IJV Ultrasonography|"Patient will be in supine position, The linear probe with frequency of 7- 12 M hz; depth of 3 cm. maximum IJV diameter (IJV-D) and area (IJV-A) will be recorded. M-mode will be used to obtain the distance between the 2 walls of the vein during inspiration and expiration.
~Then, the patient will be positioned 10° Trendelenburg and similar ultrasonographic measurements will be again performed"
16406289|NCT05025787|Drug|Placebo|BID
16406197|NCT05078606|Device|Carotid Intima Media Thickness|"US Probe is slided superiorly (toward the head) or inferiorly (toward the feet) until the bifurcation of the common carotid artery (CCA) appears on the left side of the screen. This is the ideal location for imaging and CIMT measurements.
~IMT is assessed in longitudinal view from the arterial far wall, along a 10mm length. CIMT will appear as two parallel lines (leading edges of two anatomical boundaries) from it: lumen- intima and media- adventitia interfaces perpendicular to ultrasound beams."
16406198|NCT05078606|Procedure|Spinal anesthesia|Spinal anesthesia will be performed in the sitting position at level of L3-4 or L4- 5 interspaces with a 25-gauge spinal needle. Local infiltration of skin and subcutaneous tissue with 2% lignocaine will be applied. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T8 dermatomal level block.
16406199|NCT05077709|Drug|IO102-IO103 in combination with pembrolizumab|The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
16406200|NCT05076422|Drug|BI 3006337|BI 3006337
16406201|NCT05076422|Drug|Placebo|Placebo
16406202|NCT05075278|Behavioral|Survey|A survey will be completed by the participants at the conclusion of each day.
16406203|NCT05073627|Drug|Dicloxacillin|Healthy volunteers will take 2x500 mg dicloxacillin 3 times a day for 30 days. The investigators will measure the baseline concentration of dabigatran and dicloxacillin before start of 30 days of dicloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of dicloxacillin. On day 10 and 28 the investigators will measure the concentration of dabigatran.
16406206|NCT05070065|Device|Cognitive remedy intervention with virtual reality (CEREBRUM)|Cognitive Remedial method Virtual Reality (CEREBRUM)
16406207|NCT05065216|Drug|Recombinant human tissue kallikrein|Treatment is completed by Day 22 and the duration of each individual's participation in the study will be 90 days from the time of consent to completion of all study activities.
16406208|NCT05064735|Drug|semaglutide 2.4 mg|semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
16406209|NCT05064735|Drug|semaglutide 2.4 mg (placebo)|semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
16406210|NCT05062798|Procedure|Standart bottle|"After the surgery, standard bottle will be used for feeding.
~Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form.
~Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made."
16406211|NCT05062798|Procedure|Squeezable bottle|"After the surgery, squeezable bottle will be used for feeding.
~Following the completion of the surgery,feeding process evaluation will be performed until the discharge by using the feeding evaluation form.
~Patients will be given a follow-up appointment 2 weeks after the operation and a feeding process evaluation will be made."
16406213|NCT05058911|Behavioral|Internet-delivered exposure-based cognitive behavior therapy|The primary treatment component is exposure to stimuli (situations and activities) that give rise to pain, distress, and unwanted emotional responses. The treatment proceeds in accordance with functional analysis. Exercises are tailored for the patient so that, for example, individuals whose main coping strategy is to be overly active (i.e., persistence behavior) are encouraged to sit down and observe pain and other aversive bodily sensations as they arise. The protocol also includes regular exercises where the participant is encouraged to observe and name physical sensations without acting on them.
16406214|NCT05058911|Behavioral|Internet-delivered traditional cognitive behavior therapy|This treatment is based on components typical of T-CBT for FM, such as relaxation, activity planning or pacing, cognitive restructuring techniques and stress management strategies.
16406215|NCT05058638|Drug|Aquamin|Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
16406216|NCT05058157|Dietary Supplement|different ketogenic formulae|The research product may be in a form of powder to reconstitute or in a ready-to-drink format.
16406217|NCT05058092|Device|Immediate Remedee Solution|"D0 to M3: Remedee Solution + medical care
~M3 to M6: Remedee Solution without personalized support + medical care
~M6 to M9: medical care only"
16406218|NCT05058092|Device|Delayed Remedee Solution|"D0 to M3: medical care only
~M3 to M6: Remedee Solution + medical care
~M6 to M9: Remedee Solution without personalized support + medical care"
16406219|NCT05054621|Biological|Heterologous prime-boost schedule with AZD1222 and MVC-COV1901|Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
16406220|NCT05054621|Biological|Homologous prime-boost schedule with two doses of AZD1222|Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
16406221|NCT05053711|Device|rTMS+rPMS_iTBS_M|Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at median nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
16406222|NCT05053711|Device|rTMS+rPMS_cTBS_M|Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at median nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
16406290|NCT05023967|Drug|Extended Release Metformin Hydrochloride|Given PO
16406223|NCT05053711|Device|rTMS+sham rPMS_M|Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at median nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
16406224|NCT05053711|Device|rTMS+rPMS_iTBS_U|Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at ulnaris nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
16406225|NCT05053711|Device|rTMS+rPMS_cTBS_U|Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at ulnar nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
16406226|NCT05053711|Device|rTMS+sham rPMS_U|Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at ulnar nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
16406227|NCT05051995|Drug|Open-label placebo|Prior to the open-label placebo administration, an explanation why placebos without concealment might be effective is offered. Participants receive placebo pills with the instruction to take 2 pills daily for 2 weeks.
16406228|NCT05051995|Other|No-treatment|During the no-treatment phase, participants receive no treatment for 2 weeks.
16406231|NCT05049616|Drug|ACE Inhibitors and Diuretics|Hctz/Lisinopril (brand name: Zestoretic)
16406232|NCT05049616|Drug|NIFEdipine ER|Extended release nifedipine
16406233|NCT05044845|Behavioral|Interview|Semi structured interview will be conducted virtually using an online video-conferencing platform, phone or in person.
16406234|NCT05043883|Device|CathVision Cube® system|Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the commercial (bearing CE mark) EP recording systems LabSystem Pro, Boston Scientific EP, or EP-Tracer, Schwarzer Cardiotek. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the PVI Analyzer will be performed offline and retrospectively.
16406235|NCT05042609|Drug|TRS01|TRS01 eye drops Dosed four times a day (QID)
16406236|NCT05042609|Drug|FDA approved steroid eye drop|FDA approved steroid eye drop Dosed four times a day (QID)
16406237|NCT05040971|Drug|Semaglutide 2.4 mg|Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg
16406238|NCT05040971|Drug|Placebo|Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week
16406239|NCT05040308|Other|Integrating PrEP delivery|Integration of PrEP delivery services in NSP and MAT programs
16406240|NCT05039775|Device|EROS device|Eros is a small, hand-held device fitted with a removable, replaceable small plastic cup used as a natural way to initiate female sexual response. It was originally cleared by the FDA in April 2000 for the treatment of Female Sexual Arousal Disorder (FSAD), which includes problems with sexual arousal and orgasm.
16406242|NCT05038306|Drug|Chinese medicine WT|The Chinese medicine WT is thought to be neurotrophic, and its major constituent may benefit IGF-1 in animal studies, or certain healthy human group. WT is safe in clinical use in Asia.
16406243|NCT05037201|Behavioral|Text message|The intervention arm will receive a text message stating that the vaccine is reserved for them on a specific date. They will have the ability to reschedule to a different day, opt-out of this text messaging intervention, or if previously vaccinated they can upload documentation to the Ascension website.
16406244|NCT05036915|Procedure|Pacifier randomly|"Common Action Steps:
~Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained.
~Inclusion and exclusion criteria are evaluated.
~Study group is determined in line with the randomization order of the newborn to be included in the study.
~First part of the patient information and follow-up form is completed.
~Feeding content, amount and method are determined by the physician.
~Action Steps of the Control Group:
~* Pacifier is randomly given to the infant for 30 min independent from feeding during the day.
~Common procedure steps are applied.
~Procedure steps are applied in accordance with the Neonatal Nursing Protocols according to the newborn's feeding method.
~Second part of the patient information and follow-up form is completed daily."
16406287|NCT05025787|Drug|Celecoxib|Celecoxib 100mg BID was selected as the active comparator for its documented analgesic effects and favorable gastrointestinal (GI) profile.
16406245|NCT05036915|Procedure|Pacifier other|"Procedure Steps of the Experimental Group:
~Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.
~Common procedure steps are applied.
~Pacifier is given for 5 min before each feeding.
~Procedure steps are applied in accordance with the Neonatal Nursing Protocols according to the newborn's feeding method.
~Second part of the patient information and follow-up form is completed daily."
16406246|NCT05036876|Drug|Degludec|Treatment with insulin degludec when compared to insulin glargine U-300 will result in similar blood glucose control in hospitalized patients with type 2 diabetes.
16406247|NCT05036876|Drug|Glargine U300|Treatment with insulin glargine U300 when compared to insulin degludec will result in similar blood glucose control in hospitalized patients with type 2 diabetes.
16406248|NCT05036096|Device|CBBCT Imaging|Both breasts will be scanned by CBBCT. Only one breast will be scanned if the patient had mastectomy.
16406249|NCT05036096|Device|Digital Mammography|Both breasts will take digital mammography standard views (CC, MLO) Only one breast will take digital mammography standard views if the patient had mastectomy.
16406260|NCT05035095|Drug|Oral semaglutide|Participants will receive a daily dose of oral semaglutide.
16406261|NCT05035095|Drug|Placebo (semaglutide)|Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
16406262|NCT05035082|Drug|semaglutide|Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.
16406263|NCT05035082|Drug|oral glucose-lowering medications (commercially available)|Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.
16406264|NCT05034042|Drug|Fezolinetant|oral
16406265|NCT05034042|Drug|Placebo|oral
16406266|NCT05033431|Drug|Brazikumab|Participants will receive IV or SC injection of brazikumab as per the group they are assigned.
16406267|NCT05033132|Drug|Balstilimab|Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
16406268|NCT05033132|Drug|Balstilimab + Zalifrelimab|A PD-1 antibody in combination with a CTLA-4 antibody.
16406269|NCT05031442|Device|RH1 (low waist)|Investigational product variant 1 low waist
16406270|NCT05031442|Device|Reference variant 1 (low waist)|Reference product variant 1
16406271|NCT05031442|Device|RC2 (high waist)|Investigational product variant 2 high waist
16406272|NCT05031442|Device|Reference variant 2 (high waist)|Reference product variant 2
16406273|NCT05030844|Behavioral|Diabetes Education and Video Call-based Motivational Interviewing|"IMB model-based interventions were applied to the intervention group for 12 weeks. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a Diabetes Management Education Booklet prepared by the researchers. For the motivation component of the IMB model, a 30-minute motivational interview was made with individual video calls once every two weeks starting from the third week. The control group received usual care. HbA1c, BMI, diabetes knowledge, health belief, diabetes self-efficacy, and diabetes self-management were measured at baseline, at 12 weeks, and at 24 weeks."
16406291|NCT05023967|Other|Monitoring|Use continuous glucose monitoring system
16406292|NCT05023967|Other|Nutritional Assessment|Receive nutritional counseling
16406293|NCT05023967|Other|Short-Term Fasting|Perform intermittent fasting
16406294|NCT05022810|Drug|New Paracetamol Oral Suspension (24 mg/ml)|After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
16406295|NCT05022810|Drug|Panadol B&I Oral Suspension (24 mg/ml paracetamol)|After an overnight fasting for at least 10 hours, Panadol B&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
16406296|NCT05017948|Other|Risk score based intervention|Targeted interventions based off of risk score software
16406297|NCT05017857|Device|RepetiveTranscrainal Magnetic Stimulation (rTMS)|RepetiveTranscrainal Magnetic Stimulation (rTMS): rTMS is a non-invasive electromagnetic stimulation of the brain. A train of electric pulses is delivered at the same intensity over a set period of time to a targeted region of the brain. The current stimulates or suppresses neuronal activity based on the frequency and inter-train interval between the pulses.
16406298|NCT05017857|Behavioral|Problem-Solving Training (PST)|Problem-Solving Training (PST) is a metacognitive strategy training in which patients are guided through a process of conscious self-assessment resulting in problem identification, generation of solutions, development of specific goals and action plans, and evaluation and revision of plans as needed. PST thus helps to circumvent impulsive or unrealistic problem-solving attempts that lead to failure, discouragement, and feelings of helplessness.
16406301|NCT05016570|Behavioral|Picture narrative information format|Lung screening information formatted as picture narratives
16406302|NCT05016570|Behavioral|Text with pictures information format|Lung screening information formatted as text and non-narrative pictures
16406303|NCT05016570|Behavioral|Text-only information format|Lung screening information formatted as text with no pictures
16406304|NCT05016479|Device|Accelerated repetitive Transcranial Magnetic Stimulation|arTMS is a non-invasive brain stimulation technique. It will be used a MagPro R30 with a Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
16406305|NCT05016167|Procedure|Replacement every 24 hours|"Processing Steps:
~The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours. During the 24-hour follow-up, patients whose electrodes were removed for any reason were excluded from the sample.
~Immediately after the drying, skin moisture measurement was made in the right 2nd intercostal space (ICA), left 2nd ICA, and midclavicular 5th ICA regions.
~The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer.
~The data were recorded."
16406306|NCT05016167|Procedure|Replacement every 12 hours|"Processing Steps:
~Monitoring electrodes were removed at the end of the 12th hour. When removing the monitoring electrodes, the area was first wetted using a disinfectant and dried using a sponge after removing the electrodes.
~Immediately after the drying, skin moisture measurement was made in the right 2nd ICA, left 2nd ICA and midclavicular 5th ICA regions.
~The skin condition was evaluated from these areas monitored using the skin condition score by the researcher and another independent observer.
~Monitored again.
~Monitoring electrodes were removed at the end of the 24th hour. Cleaning and drying were done immediately after removal.
~Immediately after drying, skin moisture was measured from the monitored areas.
~The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer.
~The data were recorded."
16406307|NCT05015998|Other|Non-interventional|Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs
16406308|NCT05013879|Device|Kinesio(R)Tape for edema control|Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.
16406309|NCT05012488|Other|Comparison of gait and foot pressure|The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system. The system has production of 3D motion analysis and force measurement technologies for biomechanics. When the treadmill is in static and dynamic condition, strong pressure distribution measurement will be taken.
16406311|NCT05012046|Other|Orange juice|Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice (Tropicana Pure Premium Original, No Pulp) will provide 110 calories.
16406312|NCT05012046|Other|Orange flavoured drink|Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink (Fruité® Orange Drink) will provide 96 calories.
16406313|NCT05012046|Other|Water|Matched for volume (240 mL/ 8 oz) of other test beverages. Control beverage (no caloric contribution).
16406314|NCT05010421|Drug|Clobetasol 0.05% Emollient Top Cream|Topical corticosteroid treatment of affected vulvar skin areas.
16406315|NCT05010421|Device|Non-ablative CO2 Laser|Superficial non-ablative laser treatment of affected vulvar skin areas.
16406354|NCT04980222|Drug|Glofitamab|Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
16406355|NCT04980222|Drug|Tocilizumab|Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
16406356|NCT04980222|Drug|Doxorubicin|Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
16406320|NCT05009225|Other|Comprehensive ED AF management tool|Managing atrial fibrillation (AF) patients in the emergency department (ED) is complex, often requiring many separate decisions: How to best reduce the heart rate? Should emergency physicians attempt cardioversion? If so, how? Does this patient need stroke prevention? The investigators' CDSS provides emergency physicians with a one-stop, evidence-based resource that addresses all aspects of ED AF management.
16406321|NCT05008809|Drug|mFOLFOX6|Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Leucovorin: 400 mg/m², 1-2 h IV infusion on d1 5-FU: (optional: 400 mg/m² bolus, 2-5 min IV infusion), 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
16406322|NCT05008809|Drug|mFOLFOXIRI|Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Irinotecan: 150 mg/m², 90 min IV infusion on d1 Leucovorin: 400 mg/m², 1-2 h IV infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
16406323|NCT05006716|Drug|BGB-16673|BGB-16673 doses are to be administered as a once daily regimen
16406327|NCT05003349|Other|Occlusal Splint (OS).|OS will be made of heat-cured acrylic by the same specialized dentist. These intraoral devices will be flate, rigid, will cover the entire dental arch, and will have the lowest possible height. The perimeter of the splint will have at least 11 dental contacts, light, symmetrical and pinpoint as possible. The patients will be instructed to use the splint every night during the study Two supervisions will be carried out 30 and 60 days after the use of the OS, in order to stabilize the contact points.
16406328|NCT05003349|Other|Pain Neuroscience Education (PNE).|"A power point presentation with metaphors and animated videos will be used. The PNE will be held in 10 sessions of 20 minutes each. The intervention will be developed using content according to the book Explain Pain and the web page www.retrainpain.org."
16406329|NCT05003349|Other|Motor Imagery (MI).|"The participants will have to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The procedure will begin with a familiarization test with the Basic level followed by a laterality discrimination task. It will be performed using 20 images, with 5 seconds for each image, beginning with the Vanilla program and progressively increasing the difficulty using the Context and Abstract programs. The estimated time to complete the task will be about 10 minutes per session."
16406330|NCT05003349|Other|Action Observation (AO).|The patients will see videos showing the jaw and cervical exercises with the same series and repetitions that they will actively perform in the session. Therefore, the training of the action observation will be carried out dynamically. The patient will be asked to think and visualize the movement that he/she will have to perform later. It is estimated 10 minutes per session for the AO.
16406331|NCT05003349|Other|Jaw and Neck Exercises (JNE)|A jaw and neck exercise program will be carried out in 3 series of 10 repetitions per session will be planned with 1minute rest between exercise. The exercises will be executed with a total time per session of 20 minutes, initially in the clinic and later at home. In the clinic, verbal and tactile instructions will be provided for the correct execution of the exercises and later they will be sent through WhatsApp and / or mail to perform them at home.
16406332|NCT05003349|Other|Counselling.|Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth).
16406333|NCT05003310|Device|Active Stimulation|Stimulation will be turned ON and applied during each day of the period.
16406334|NCT05003310|Device|Sham Stimulation|Sham stimulation will be provided during the period
16406335|NCT05003310|Drug|Baricitinib|Baricitinib (2 mg) is administered daily during the period.
16406336|NCT05003310|Drug|Background Treatment|Stable dose of standard background treatment (e.g., csDMARD therapy)
16406337|NCT05001451|Biological|GDX012 Suspension for IV Infusion|"Biological: GDX012 Suspension for IV Infusion (single dose) following chemotherapy for lymphodepletion.
~Drug: Fludarabine; chemotherapy for lymphodepletion
~Drug: Cyclophosphamide; chemotherapy for lymphodepletion"
16406338|NCT04999527|Drug|DISC-0974|DISC-0974 is administered (IV infusion) as a single dose
16406339|NCT04999527|Drug|Placebo|Placebo is administered (IV infusion) as a single dose
16406340|NCT04997187|Dietary Supplement|Bacillus coagulans group|Bacillus coagulans 400 mg/day for 12 weeks
16406341|NCT04997187|Dietary Supplement|Control group|Placebo 400 mg/day for 12 weeks
16406342|NCT04993560|Biological|BBIBP-CorV|Inactivated virus COVID-19 vaccine
16406343|NCT04993560|Biological|BNT162b2|mRNA-based COVID-19 vaccine
16406344|NCT04988152|Biological|sotrovimab|sotrovimab IV infusion, single dose
16406345|NCT04988152|Other|Placebo to Biologic|Sterile 0.9% (w/v) sodium chloride solution
16406346|NCT04988152|Biological|sotrovimab|Sotrovimab IM injection, single dose
16406347|NCT04988152|Other|Placebo to Biologic|Sterile 0.9% (w/v) sodium chloride solution
16406348|NCT04988035|Drug|Danicopan|Danicopan is a small molecule, orally administered complement factor D (FD) inhibitor
16406349|NCT04988035|Other|Placebo|Danicopan matching placebo tablet
16406350|NCT04988035|Drug|Remdesivir|Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
16406351|NCT04987944|Drug|Zavegepant|150 mg BID
16406352|NCT04987944|Drug|Placebo|Placebo matching active drug
16406353|NCT04987229|Drug|OLZ/SAM|Olanzapine and Samidorphan fixed dose coated tablet taken once daily
16406950|NCT04316117|Procedure|Positron Emission Tomography|Undergo PET/CT
16406357|NCT04980222|Drug|Vincristine|Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
16406358|NCT04980222|Drug|Prednisone|Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
16406359|NCT04980222|Drug|Rituximab|Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
16406360|NCT04980222|Drug|Cyclophosphamide|Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.
16406361|NCT04975997|Drug|CC-220|Oral CC-220 1.6mg on Days 1 to 21 of a 28-day cycle
16406362|NCT04975997|Drug|Dexamethasone|Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
16406363|NCT04975997|Drug|Daratumumab|Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
16406364|NCT04975997|Drug|Daratumumab|Subcutaneous Daratumumab 1800mg on Days 1, 8 and 15 for Cycles 1 to 3, on Day 1 for Cycles 4 to 8, and on Day 1 for Cycle 9
16406365|NCT04975997|Drug|Dexamethasone|Oral dexamethasone 20mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 for the first 8 bortezomib treatment cycles. For participants older than 75 years, underweight (BMI < 18.5), have poorly controlled diabetes, or prior intolerance/adverse event to steroid therapy, dexamethasone may be administered at a dose of 10 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12.
16406366|NCT04975997|Drug|Bortezomib|Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
16406367|NCT04975607|Behavioral|Music Therapy|The three live music therapy sessions will be provided after lung transplant. All three music therapy sessions will employ a variety of data-based interventions to address pain, anxiety, and improve relaxation. Music therapy interventions may include patient preferred live music, active music listening, singing or other active music-making, and guided breathing and relaxation.
16406368|NCT04971811|Other|Snack with energy density less than 1.5 kcal/g|Snack meal with snack food having energy density less than 1.5 kcal/g
16406369|NCT04971811|Other|Snack with energy density greater than 1.5 kcal/g|Snack meal with snack food having energy density greater than 1.5 kcal/g
16406370|NCT04971785|Drug|Semaglutide (SEMA)|Administered as subcutaneous (SC) injection
16406371|NCT04971785|Drug|Cilofexor (CILO)/Firsocostat (FIR)|Tablets administered orally
16406372|NCT04971785|Drug|PTM SEMA|Administered as SC injection
16406373|NCT04971785|Drug|PTM CILO/FIR|Tablets administered orally
16406374|NCT04969250|Biological|Moderna mRNA-1273 COVID-19 vaccine|100 µg intramuscular injection
16406375|NCT04969250|Biological|Pfizer BNT162b2 COVID-19 vaccine|30 µg intramuscular injection
16406376|NCT04966013|Device|RD-X19|Investigational device that uses safe electromagnetic energy to target the oropharynx.
16406377|NCT04966013|Device|Sham|Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro..
16406379|NCT04961762|Other|Navigator Program|The main role of the Homeless Outreach Counsellor is to support continuity and comprehensiveness of care by helping participants follow their post-discharge plans and facilitating strong links with community-based health and social services. The Homeless Outreach Counsellor also helps address specific needs of participants, develop comprehensive care plans with members of patient's multidisciplinary circle of care, and facilitate the transition of clients to long-term community-based health and social services.
16406380|NCT04958577|Device|Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)|This device is a medical device but will be used only observationally--this device takes a patient's symptoms into account by asking questions and gives a ranked list of likely conditions that the patient might have based on the answers to these questions. The assessment report also includes urgency advice levels, that is, which care the patient should proceed to based on the condition suggestions. The WRA is used by the patient directly and the HDA is used by the doctor to ask the questions to the patient.
16406381|NCT04956718|Other|Cold Pressor Test (CPT)|Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time.
16406382|NCT04956718|Other|Placebo NaCl Nasal spray|placebo nasal spray containing NaCl solution
16406383|NCT04955899|Device|Active Stimulation|The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
16406386|NCT04950244|Diagnostic Test|High-sensitivity cardiac troponin I (hs-cTnI)|"Capillary and veinous whole blood sampling for hs-cTnI was collected. The sample was tested at the bedside with a point-of-care device (Atellica VTLi, Siemens Healthineers).
~The result of both hs-c TnI values obtained was blinded to the treating physician"
16406387|NCT04949399|Drug|OnabotulinumtoxinA|Injection
16406388|NCT04949399|Drug|Placebo|Injection
16406389|NCT04948736|Combination Product|Combined exercise and nutrition intervention|"Combined exercise and nutrition intervention for 12 weeks. Exercise intervention includes flexibility exercise, strength exercise, aerobic exercise and balance exercise according to protocol.
~Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake to provide customized diet and high protein drink"
16406390|NCT04948736|Other|Conventional medial care|Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. During intervention period, patients maintain the usual activity and dietary habits
16406391|NCT04947085|Drug|Ketamine via Intravenous|Ketamine administration in sub-dissociative doses
16406392|NCT04947085|Drug|Ketamine via BAN|Ketamine administered via Breath-Actuated Nebulizer (BAN)
16406393|NCT04945512|Procedure|Epidural Analgesia|In the anesthesia preparation room, an epidutal catheter will be placed with a toue needle through the L4-5 spinal space. After induction of general anesthesia, 10 ml of 0.25% bupivacaine will be injected through the epidural catheter.Afterwards, peroperative and postoperative analgesia will be provided with epidural PCA.
16406394|NCT04945460|Drug|Sotatercept|Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
16406395|NCT04945460|Drug|Placebo|Placebo
16406396|NCT04945330|Drug|Larotrectinib (Vitrakvi, BAY2757556)|Follow clinical practice
16406397|NCT04945109|Other|Mankai beverage|Recommended background healthy diet with Mankai supplementation after main meal (300 ml)
16406398|NCT04945109|Other|Water (control)|Recommended background healthy diet with water supplementation after main meal (300 ml)
16406399|NCT04944888|Drug|Eliglustat|Eliglustat, 84mg; Enrolled patients will be assigned to Arm A to Arm D according to age, tumor burden, tumor progression and previous adverse events or immune checkpoint inhibitor. For patients assigned to Arm A or D who fail to achieve PR or CR in the initial 6-8 weeks or do not exhibit clinical or immunological favorable signals, his or her following treatment will be switched to Arm B or Arm C.
16406400|NCT04944888|Drug|Immune checkpoint inhibitor|immune checkpoint inhibitor (physician decided).
16406401|NCT04943861|Behavioral|weCare/Secure|The weCare intervention is based on the social cognitive and empowerment theories and social support and is currently designed to reduce missed HIV care appointments and increase viral suppression among PWH who are newly diagnosed or out of care through the use of peer navigation and mHealth
16406402|NCT04943861|Other|Usual Care|There is no peer navigation within usual care.
16406403|NCT04943159|Drug|Afamelanotide|Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
16406404|NCT04938726|Dietary Supplement|Ketone Monoester|Ketone supplement will be taken by mouth at a dose of 15 mL twice per day
16406405|NCT04934800|Drug|Cladribine|No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.
16406406|NCT04934293|Procedure|Virtual reality|Before proton therapy, virtual reality sessions will be performed.
16406417|NCT04932512|Drug|ION224|ION224 will be administered by SC injection.
16406418|NCT04932512|Other|Placebo|ION224-matching placebo solution will be administered by SC injection.
16406419|NCT04931459|Drug|ACU193|Intravenous ACU193
16406420|NCT04931459|Drug|Placebo|Intravenous Placebo
16406421|NCT04931056|Device|Titanium Facial Plates|The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136.
16406422|NCT04931056|Device|Titanium Mandibular Plates|"The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system.
~Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length."
16406423|NCT04931056|Device|Add-on Condyle|The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease.
16406424|NCT04931056|Device|HTR-PEKK|The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone.
16406426|NCT04926077|Device|DreamKit|The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance.
16406427|NCT04925193|Drug|Selinexor|Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
16406428|NCT04925193|Drug|Pomalidomide|Oral Table
16406429|NCT04925193|Drug|Daratumumab|Injection
16406430|NCT04925193|Drug|Carfilzomib|Injection
16406431|NCT04925193|Drug|Dexamethasone|Oral tablet or injection
16406432|NCT04922554|Drug|Omadacycline Oral Tablet|omadacycline 300 mg orally, once daily (150 mg tablets x 2)
16406433|NCT04922554|Drug|Placebo|placebo tablets resembling omadacycline orally, once daily (x 2 tablets)
16406434|NCT04920292|Drug|Oxfendazole|Oxfendazole is a benzimidazole anthelminthic drug.
16406435|NCT04920292|Drug|Placebo|The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.
16406436|NCT04919642|Drug|TT-00420|TT-00420 tablet, administered orally once daily
16406437|NCT04918108|Biological|inflammatory response|laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
16406438|NCT04916795|Drug|Vupanorsen|80 mg subcutaneous injection
16406439|NCT04916795|Drug|Vupanorsen|80 mg subcutaneous injection
16406442|NCT04913675|Biological|VIR-7831|500mg IV
16406443|NCT04913675|Biological|VIR-7831|500mg IM
16406444|NCT04913675|Biological|VIR-7831|250mg IM
16406445|NCT04911270|Device|Computer Decision Support Tool Intervention Group|Computer Decision Support Tool using Bayesian estimation to dose IV vancomycin in pediatric patients using AUC24/MIC
16406446|NCT04911270|Other|Matched Historical Controls|Vancomycin dosing based on standard hospital methods, with dose adjustments based on vancomycin trough targets
16406447|NCT04909099|Other|Standard treatment|"Participants shall fill the EARS-Ar questionnaire three times within one month in addition to other questionnaires including the Roland Morris Disability Questionnaire (RMDQ) for low back pain (LBP) patients, and the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA patients, in addition to the Fear-Avoidance Beliefs Questionnaire (FABQ), the Numeric Pain Rating Scale (NPRS), and the Global Rating of Change Scale (GRoC).
~The first time will be one week after enrolling in the study and receiving the prescribed home exercise program. the second time will be 3-6 days later to test the reliability of the EARS-Ar. After another week, participants will refill the EARS-Ar and the GRoC to test responsiveness."
16406448|NCT04908189|Drug|Deucravacitinib|Specified dose on specified days
16406449|NCT04908189|Other|Placebo|Specified dose on specified days
16406450|NCT04908189|Drug|Apremilast|Specified dose on specified days
16406451|NCT04906421|Drug|TVB-2640|Oral dose, tablet
16406452|NCT04906421|Drug|TVB-2640|Oral dose, tablet
16406453|NCT04906421|Other|Placebo|Oral dose, tablet
16406454|NCT04905940|Drug|Turmeric mouthwash|Turmeric mouthwash evaluation in controlling halitosis
16406455|NCT04905381|Behavioral|Usual care|This arm receives usual care (control group)
16406456|NCT04905381|Behavioral|LENA Star Program sessions|LENA Start is an evidence-based community program designed to engage families and help them learn how to increase conversation with their children during the first few years of life.
16406457|NCT04904770|Device|Scoop stretcher|Already included in arm/group description
16406458|NCT04904770|Device|Vacuum mattress|Already included in arm/group description
16406459|NCT04903821|Drug|BAY3427080|Orally administered, single dose on Day 1 and single does once daily on Day 3 to 8
16406462|NCT04898309|Drug|GNR-038, 50 МЕ/ kg|A single intravenous infusion of GNR-038, 50 МЕ/ kg less than 5 hours after the onset of edema.
16406463|NCT04898309|Drug|GNR-038, 100 МЕ/ kg|A single intravenous infusion of GNR-038, 100 МЕ/ kg less than 5 hours after the onset of edema.
16406464|NCT04898309|Drug|Berinert®, 20 МЕ/ kg|A single intravenous infusion of Berinert®, 20 МЕ/ kg less than 5 hours after the onset of edema.
16406465|NCT04898309|Drug|Placebo|A single intravenous infusion of Placebo less than 5 hours after the onset of edema.
16406466|NCT04898309|Drug|GNR-038. The dose will be selected according to results of stage 1 clinical trial.|A single intravenous infusion of GNR-038 less than 5 hours after the onset of edema.
16406467|NCT04898309|Drug|Berinert®, 20 МЕ/ kg|A single intravenous infusion of Berinert®, 20 МЕ/ kg less than 5 hours after the onset of edema.
16406468|NCT04897295|Device|Active transcranial Direct Current Stimulation|tDCS is a non-invasive brain stimulation technique. The investigators will use a BrainSTIM (EMS, Bologna, Italy)
16406469|NCT04897295|Device|Sham transcranial Direct Current Stimulation|tDCS is a non-invasive brain stimulation technique. The investigators will use a BrainSTIM (EMS, Bologna, Italy)
16406471|NCT04893967|Device|Magnetic Tape|Magnetic tape® is applied without creating any tension over low back
16406472|NCT04893967|Device|kinesiology tape|Kinesiology Tape is applied without creating any tension over low back
16406512|NCT04858425|Drug|Placebo|Matched placebo tablets 400 mg 3 times daily for 14 days
16406952|NCT04313881|Drug|Magrolimab|Administered intravenously
16406476|NCT04888611|Biological|Camrelizumab plus GSC-DCV|Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and GSC-DCV IH every 3 weeks in the absence of disease progression or unacceptable toxicity.
16406477|NCT04888611|Biological|Camrelizumab plus Placebo|Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and Placebo IH every 3 weeks in the absence of disease progression or unacceptable toxicity.
16406480|NCT04885816|Device|Drug Eluting Balloon (DEB)|"Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DEB, and the diameter and pressure used aims a balloon to artery ratio of 1. In case of significant recoil (more than 30% for main vessels and 50% for side vessels), coronary perforation or flow limiting dissection, provisional stent will be implanted with a stent to artery ratio of 1.1 with stent post-dilatation when indicated. Device will be used in accordance with the CE mark instructions.
~DAPT will be given for a month with aspirin and a P2Y12 inhibitor (clopidogrel will be favored). Single anti-platelet therapy (SAPT) with aspirin will be continued thereafter."
16406481|NCT04885816|Device|Drug Eluting Stents (DES)|"Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DES with an stent to artery ratio of 1.1. Post-dilatation will be performed when indicated. Devices will be used in accordance with the CE mark instructions.
~DAPT will be indicated according to actual international guidelines."
16406482|NCT04883346|Drug|Liraglutide|Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
16406483|NCT04880109|Drug|APX-115|Oral administration of APX-115 100 mg capsule once daily for 14 days
16406484|NCT04880109|Drug|Placebo|Oral administration of placebo capsule once daily for 14 days
16406485|NCT04879940|Device|Merit Medical Embospheres|Prostatic Artery Embolization will performed as an outpatient procedure in Interventional Radiology. Bilateral selective pelvic angiograms will be performed to localize the prostatic arteries. Cone-beam or 3D computed tomography (CT) will be performed prior to embolization, if technically feasible and necessary. Embolization will be performed using Merit Medical Embospheres.
16406486|NCT04879940|Radiation|Radiation Therapy|Patients will undergo standard of care definitive radiation therapy.
16406487|NCT04879329|Drug|Disitamab vedotin|Given into the vein (IV; intravenous) every 2 weeks.
16406488|NCT04877691|Drug|Medi-546|"Patients will have IP administered or will self-administer IP under supervision by site staff at Weeks 0, 1, and 2. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration, as follows:
~- W0 and W1 - 1 kit to be administered at clinic
~- W2 - 3 kits (1 to be administered at clinic, 2 to be taken home)
~- W4 - W48 (every 4 weeks) - 5 kits (1 to be administered at clinic, 4 to be taken home) Patients will have approximately 65 kits (including back-up kits) dispensed to them over the course of the 52-week treatment period"
16406489|NCT04877691|Drug|Placebo|Solution for injection in aPFS
16406492|NCT04876248|Biological|Belantamab Mafodotin|Given IV
16406493|NCT04876248|Drug|Lenalidomide|Given PO
16406494|NCT04870112|Drug|Durvalumab|Anti-PD-L1 antibody
16406495|NCT04870112|Drug|Cisplatin|Chemotherapy
16406496|NCT04870112|Drug|Carboplatin|Chemotherapy
16406497|NCT04870112|Drug|Etoposide|Chemotherapy
16406498|NCT04870034|Drug|Binimetinib|Given PO
16406499|NCT04870034|Drug|Palbociclib|Given PO
16406500|NCT04870034|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16406503|NCT04865770|Drug|Semaglutide|Semaglutide given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.
16406504|NCT04865770|Drug|Placebo (Semaglutide)|Placebo (Semaglutide) given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.
16406505|NCT04865614|Drug|Etomidate|Use of etomidate
16406506|NCT04865614|Drug|Sevoflurane|Use of sevoflurane
16406507|NCT04859699|Behavioral|COVID-19 Health Education Comic Books and Videos|Comic books and videos will be shared with intervention students and their parents to provide education on COVID-19 topics such as masking, social distancing and COVID-19 testing
16406508|NCT04859517|Drug|ADG20|Single dose of ADG20
16406509|NCT04859517|Drug|Placebo|Single dose of placebo
16406510|NCT04858945|Behavioral|Teach-back method|During the trial, women from teach-back group and controlled group will receive three education sessions The topics discussed at the first session included delivery mode, labor process and pain relief, newborn health and care (common health issues and care skills), perinatal die and excises, and perinatal psychological health. The topics discussed at the second session includ postpartum recovery, postpartum maternal health, perineum care (diet, oral care, perineal care, and hygiene), breastfeeding, postpartum blue and depression, neonatal care, neonatal screening tests, newborn vaccination and early child development. At two-week postpartum, the educator answers questions raised by the woman and gives advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman.
16406511|NCT04858425|Drug|Niclosamide|Niclosamide tablets 400 mg 3 times daily for 14 days
16406513|NCT04857151|Behavioral|App based mindfulness program (ABMP)|App based mindfulness program (ABMP)
16406514|NCT04855799|Drug|Aquamin|Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
16406515|NCT04854811|Drug|Roflumilast Oral Tablet|Once daily for 12 weeks
16406516|NCT04853836|Combination Product|co-ultraPEALut|Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.
16406517|NCT04853836|Procedure|Olfactory Rehab|Olfactory Rehabilitation10 minutes twice a day for all the observation period
16406518|NCT04853576|Genetic|EDIT-301|Administered by IV infusion after myeloablative conditioning with busulfan.
16406519|NCT04852328|Drug|CUE-101|CUE Biopharma will supply CUE-101, which will be provided free of charge to the patient.
16406520|NCT04850898|Biological|SAB-176|Treatment of influenza
16406521|NCT04850898|Other|Placebo|Placebo Control
16406522|NCT04849741|Drug|ION373|ION373 will be administered by ITB injection.
16406523|NCT04849741|Drug|Placebo|ION373-matching placebo will be administered by ITB injection.
16406524|NCT04849728|Drug|IVA337|A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.
16406525|NCT04849728|Drug|Placebo|A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.
16406526|NCT04848337|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
16406527|NCT04848337|Drug|Lenvatinib|Lenvatinib 20 mg orally daily.
16406528|NCT04847908|Other|Single high-intensity interval exercise intervention|Study participants perform a single bout of exercise on a cycle ergometer (high-intensity interval exercise intervention) within the first and third cycle of chemotherapy. Following a 2 minute warm-up, the interval protocol comprises 10 intervals à 15 seconds with high intensity and 60 seconds low intensity in-between. Blood samples are taken at t0 pre-exercise (after a 10 minute rest) and at t1 immediately post-exercise via central catheter (Hickman/port).
16406532|NCT04846140|Device|transcranial electrical stimulation (tES)|Transcranial electrical stimulation (tES) is a form of neuromodulation that uses constant, low direct current delivered via the electrodes on the skull. Three types of tES will be applied in this study, include a-tDCS, tACS, and tRNS. Additionally, sham stimulation will be applied as a placebo-controlled intervention.
16406533|NCT04844749|Drug|VERU-111|Based on the safety and antitumor activity of VERU-111 in the Phase 1b/2 clinical study, VERU-111 is initiating this Phase 3 clinical study of VERU-111 for the treatment of metastatic castration resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent
16406534|NCT04844749|Drug|Enzalutamide, Abiraterone, Darolutamide and Apalutamide|Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer
16406535|NCT04843761|Biological|Remdesivir|Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.
16406536|NCT04843761|Drug|Remdesivir Placebo|Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.
16406537|NCT04843761|Biological|Aviptadil|Administered by IV infusion over 12 hours per day for 3 days.
16406538|NCT04843761|Drug|Aviptadil Placebo|Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
16406539|NCT04843761|Drug|Corticosteroid|In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
16406540|NCT04841577|Biological|RSVPreF3 OA investigational vaccine|RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
16406541|NCT04841577|Biological|FLU-QIV|FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.
16406542|NCT04830501|Drug|TT-00434|Once daily [QD], 28 days/cycle.
16406543|NCT04822935|Procedure|Vertebral Body Tethering|VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.
16406544|NCT04822753|Procedure|Platelet Rich Plasma injection to the lumbar facet joint|Using standard fluoroscopic view, place a needle at the target facet joint. Inject about 1ml of study injectate.
16406545|NCT04822610|Procedure|interscalene block|peripheral nerve block
16406546|NCT04822610|Procedure|suprascapular block + axillary block|peripheral nerve block
16406547|NCT04817345|Drug|Plerixafor|Subcutaneous
16406552|NCT04815681|Behavioral|Common Elements Toolbox|COMET is an online unguided self-help intervention that lasts approximately 40-50 minutes.
16406553|NCT04815681|Behavioral|Active Control|The active control condition includes an online self-awareness program that lasts approximately 40-50 minutes. Participants in the control condition will receive access to the intervention after data collection for the study has been completed.
16406555|NCT04814394|Diagnostic Test|flowcytometry|The study of CD4,CD25,FOXP3 and PD-1 on peripheral blood sample
16406558|NCT04809805|Drug|BAY2666605|One oral solution strength of BAY2666605 will be used. Two different tablet strengths of BAY2666605 will be available.
16406559|NCT04809623|Drug|GS-5718|Tablets administered orally
16406560|NCT04809623|Drug|Placebo|Placebo to match GS-5718 tablets administered orally
16406562|NCT04807439|Device|SYNERGY XLV (Megatron) Coronary Stent System|The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >3.50 mm to <5.00 mm in diameter in lesions <28 mm in length.
16406563|NCT04804553|Drug|Apremilast|Participants will receive apremilast orally.
16406564|NCT04804553|Drug|Placebo|Participants will receive the matching placebo orally.
16406565|NCT04804254|Drug|ABBV-623|Oral Tablets
16406566|NCT04804254|Drug|ABBV-992|Oral Tablets
16406567|NCT04802733|Biological|MSK-DA01|MSK-DA01 is an experimental product derived from human embryonic stem cells. The stem cells were converted into brain cells that produce dopamine.
16406568|NCT04802733|Device|MSK-DA01 Cell Delivery Device|A device that is used for injection of fluids into the brain will be used. Some minor modifications have been made to the device to allow delivery of MSK-DA01 cells.
16406579|NCT04795856|Drug|[11C] acetate|PET Tracer
16406580|NCT04789304|Drug|BI 1595043|BI 1595043
16406581|NCT04789304|Drug|Placebo|Placebo
16406582|NCT04789304|Drug|Midazolam|Midazolam
16406583|NCT04786847|Biological|177Lu-DOTA-TLX591|TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-TLX591)
16406584|NCT04783467|Behavioral|Time Restricted Eating (TRE) Schedule|[See arm/group descriptions]
16406585|NCT04781907|Procedure|Tissue Expansion|Tissue expanders are used to increase the soft tissue envelope after mastectomy to provide adequate and healthy coverage of prosthetic breast implants.
16406586|NCT04770454|Drug|Buspiron|As this study is a non-interventional observational study, treatments are determined by the investigator in consideration of the medical condition of the subject in normal clinical practice. Therefore, information regarding dosage and administration of the drug is not provided in the study protocol; rather, the investigator determines the appropriate dose by considering the approved dose of the drug and the medical condition of the subject.
16406587|NCT04768829|Drug|Moringa oleifera leaf 10mg/100ml|ear drops
16406588|NCT04768829|Drug|Ear Drop|plain ear drop formulation without moringa
16406591|NCT04762706|Behavioral|CRUTCH Pathway|Patients will be offered referral to a behavioral medicine specialist in the novel Combined Rehabilitation Using Team Centered Help (CRUTCH) Pathway. Once enrolled, these patients will meet virtually with a psychiatrist. The psychiatrist will complete a 30-minute intake visit where he will review the patient's DT scoring, discuss contributing factors to current distress level, and assess for psychiatric comorbidities. Following this assessment, psychotherapy, psychotropic medication, and referral for social work/financial services will be offered to the patient as indicated. If more frequent behavioral health follow-up is clinically indicated, it will be provided to the patients.
16406592|NCT04761861|Drug|Vildagliptin 50 MG|Vildagliptin 50 MG tablet once daily
16406593|NCT04761861|Drug|Placebo|Placebo one tablet daily
16406606|NCT04754373|Dietary Supplement|GFA-918|Participants will be instructed to take one GFA-918 (125000 FIP Units of Lipase AY) capsule twice per day with their morning and evening meals for 12 weeks.
16406607|NCT04754373|Other|Placebo|Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.
16406646|NCT04701281|Combination Product|Intra-arterial LIOX + Capecitabine|5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine
16406609|NCT04745169|Behavioral|8 week home-based exercise program|Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.
16406610|NCT04742959|Drug|TT-00420|TT-00420 tablet will be administered orally once daily per protocol defined schedule.
16406611|NCT04742959|Combination Product|Nab-Paclitaxel|Nab-Paclitaxel would be administered via infusion on Day 1,8, and 15 of 28-day cycle
16406618|NCT04731025|Drug|Gentamicin, Cefazolin and Vancomycin|The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
16406619|NCT04731025|Other|Placebo|500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
16406620|NCT04729439|Behavioral|Homework Organization and Planning Skills (HOPS) Intervention|A behavioral/organizational skills intervention focused on improving adolescents' homework, organization, and planning skills
16406621|NCT04729439|Device|Digital Health Application (Online Platform) for Encouraging Skills Practice|This online platform can be used on participants' personal devices including laptops, phones, tablets, or other computers and is designed to encourage adolescent's skills practice, monitor and reward treatment progress, and optimize motivation in treatment
16406622|NCT04726176|Biological|Exposure to COVID-19|To study the exposure of COVID-19 on the brain and executive functioning
16406623|NCT04724291|Device|MAGNET|This study will test the accuracy of a single-use ingestible video capsule (NaviCamTM, AnX Robotica) which is remotely controlled to record images of the inside of your stomach. Participants in this research study will have symptoms for which an evaluation by a traditional tube-based endoscopy (EGD) is indicated.
16406624|NCT04722679|Drug|Non-VKA Oral Anticoagulants (NOAC)|Follow clinical practice.
16406625|NCT04722263|Radiation|Radiotherapy|15 Gy in 3 fractions
16406626|NCT04720456|Drug|SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)|The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.
16406627|NCT04720456|Drug|SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)|The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.
16406628|NCT04720157|Drug|177Lu-PSMA-617|administered intravenously once very 6 weeks (1 cycle) for 6 cycles
16406629|NCT04720157|Diagnostic Test|68Ga-PSMA-11|Single intravenous dose of approx. 150 Megabecquerel (MBq)
16406630|NCT04720157|Drug|ARDT|Administered orally on a continuous basis as per package insert and guideline
16406631|NCT04720157|Drug|ADT|ADT are administered as per physician order
16406632|NCT04720066|Diagnostic Test|Ultrasound test|point of care ultrasound performed by PEM physicians to limping children presenting to the PED compared to radiologist performed ultrasound test.
16406633|NCT04714619|Drug|CB-103|"Patients will receive CB-103 capsules orally (QD) in combination with NSAI therapy (letrozole or anastrozole, continuing prior therapy) also orally once daily, and based on a 28-day treatment cycle.
~A run-in phase for safety and tolerability of CB-103 in combination with anastrozole or letrozole will be conducted as an initial step of the phase II trial to confirm the safe dose of CB-103 in combination with NSAI given at standard dose.
~Patients will receive treatment until disease progression (as defined by RECIST v.1.1), symptomatic deterioration, unacceptable toxicity, death, consent withdrawal or study termination, whichever occurs first."
16406634|NCT04712097|Drug|Mosunetuzumab|Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12
16406635|NCT04712097|Drug|Lenalidomide|Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
16406636|NCT04712097|Drug|Rituximab|Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11
16406637|NCT04712097|Drug|Tociluzumab|Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
16406638|NCT04711824|Drug|Olaparib|Olaparib 100-300 mg twice daily up to 28 days concurrently with stereotactic radiosurgery. Three dose levels of olaparib will be explored in the Phase I portion. Olaparib will start one week prior to SRS and continue during and following SRS for up to 28 days total. One cycle will be given.
16406639|NCT04711824|Radiation|Stereotactic Radiosurgery|SRS 1-5 fractions will be given per institutional standards
16406640|NCT04711824|Drug|Durvalumab|Durvalumab 1120 mg IV over 60 minutes Day 1 of each cycle 21 day cycle.
16406641|NCT04711824|Drug|Physicians Choice systemic chemotherapy|Olaparib: 300mg PO BID; Days 1-21 Paclitaxel: 80 mg/m2 IV over 60 min; Day 8 and 15 Nab-paclitaxel:100 mg/m2 IV over 30 min; Day 8 and 15 Eribulin: 1.4 mg/m2 IV over 2-5 min; Day 1 and 8 Carboplatin: AUC 2 mg/ml/min IV over 30-60 min; Day 1 and 8 Cisplatin: 75 mg/m2 IV over 30-60 min; Day 1 Capecitabine: 1000 mg/m2 PO BID; Days 1-14 Gemcitabine: 1000 mg/m2 IV over 30 min; Day 1 and 8
16406642|NCT04707469|Drug|Oral semaglutide|Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
16406643|NCT04704544|Other|Tele-rheumatology|Participants will receive virtual visits via video conferencing and/or phone.
16406644|NCT04703205|Drug|Ivermectin 3 MG|Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state)
16406645|NCT04703205|Drug|Placebo|Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state)
16406647|NCT04699877|Drug|Gilteritinib|Oral
16406648|NCT04697628|Drug|tisotumab vedotin|2.0 mg/kg every 3 weeks (Q3W)
16406649|NCT04697628|Drug|topotecan|1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
16406650|NCT04697628|Drug|vinorelbine|30 mg/m2 IV on Days 1 and 8, every 21 days
16406651|NCT04697628|Drug|gemcitabine|1000 mg/m2 IV on Days 1 and 8, every 21 days
16406652|NCT04697628|Drug|irinotecan|100 or 125 mg/m2 IV weekly for 28 days, every 42 days
16406653|NCT04697628|Drug|pemetrexed|500 mg/m2 IV on Day 1, every 21 days
16406654|NCT04696471|Device|Continuous Theta Burst Stimulation (cTBS)|cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions
16406655|NCT04696471|Device|Sham Continuous Theta Burst Stimulation (Sham cTBS)|Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham
16406657|NCT04691128|Drug|Desflurane|After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.
16406658|NCT04691128|Drug|Propofol|After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil
16406659|NCT04689373|Diagnostic Test|VAS Score|"The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain.
~The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills."
16406661|NCT04685265|Drug|anle138b|capsule containing excipient and anle138b
16406662|NCT04685265|Drug|Placebo|matching placebo capsule containing excipient
16406663|NCT04684563|Biological|huCART19-IL18|autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)
16406664|NCT04683068|Behavioral|Message comparison|Message comparison
16406665|NCT04682821|Other|Artificial intelligence assistant system|The intervention is the use of the artificial intelligence assistant system in addition to the common training. The system is an non-invasive AI system which could help the endoscopists to diagnosis and monitor the blind spot during the gastroscope.
16406666|NCT04682522|Drug|Metronidazole Oral|250 mg Three times a day
16406667|NCT04682197|Device|Cereset Research|The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
16406668|NCT04671342|Device|DreamKit|The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.
16406669|NCT04667039|Biological|GNR-067|GNR-067 will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)
16406670|NCT04667039|Biological|Lucentis®|Lucentis® will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)
16406671|NCT04664309|Other|No intervention|No intervention
16406672|NCT04657809|Combination Product|Insulin film|Insulin suspension vials
16406673|NCT04657809|Device|Fast dissolving film|Fast dissolving film
16406674|NCT04655638|Device|High Flow Nasal Therapy|High flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%.
16406675|NCT04655638|Device|Conventional Oxygen Therapy|Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
16406676|NCT04655027|Drug|Roxadustat|The starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to < 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to < 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients.
16406677|NCT04655027|Drug|rHuEPO|The starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU [dosing will BIW], and patients on weekly dose of >6000 IU [dosing will TIW]) and on patient's haemoglobin levels.
16406678|NCT04647903|Drug|ADAIR 10 mg IR tablets|manipulated ADAIR 3x10mg
16406679|NCT04647903|Drug|d-amphetamine sulfate|crushed d-amphetamine sulfate 3x10mg
16406680|NCT04647903|Drug|Placebo|placebo for oral and intranasal administration
16406681|NCT04645264|Device|Foley Catheter|The patient is catheterized during surgery.
16406720|NCT04603495|Drug|Placebo|Placebo tablets are designed to match CPI-0610 tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as CPI-0610.
16406721|NCT04601584|Biological|GNR-084, 0.01 ng/kg|0.01 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16406722|NCT04601584|Biological|GNR-084, 0.1 ng/kg|0.1 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16406685|NCT04643431|Diagnostic Test|Perflutren|The ultrasound contrast agent is used to improve the quality of ultrasound imaging and is infused over 5-10 minutes. The contrast agent consists of the gas-filled microbubbles smaller than the capillary size which circulate in the vascular system. The contrast agent is cleared from the body naturally within 30 minutes.
16406686|NCT04642638|Drug|INO-4800|INO-4800 will be administered ID on Day 0 and Day 28.
16406687|NCT04642638|Device|CELLECTRA® 2000|EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28.
16406688|NCT04642638|Drug|Placebo|Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28.
16406689|NCT04642638|Device|CELLECTRA® 2000|EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
16406690|NCT04640142|Biological|Newnorm|Newnorm is a 20% human normal immunoglobulin for SC infusion.
16406695|NCT04634435|Combination Product|CIML NK Cells plus KP1237 and low dose IL-2|Single dose infusion of CIML NK Cells plus KP1237 followed by low dose IL-2
16406696|NCT04631718|Radiation|Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)|"MRI-based QSM methods estimate the susceptibility of tissues based on measuring the magnetic field distortion produced by the tissues themselves.
~Upon successful validation, MRI-based abdominal QSM will provide accurate, repeatable, and reproducible quantification of Liver iron concentration (LIC) that is independent of the distribution of iron and does not require calibration."
16406697|NCT04631705|Biological|DZIF-10c|Inhaled administration of the human monoclonal antibody DZIF-10c
16406698|NCT04631705|Biological|DZIF-10c|Intravenous administration of the human monoclonal antibody DZIF-10c
16406699|NCT04631705|Drug|Placebo|Inhalation of DZIF-10c diluent as placebo
16406700|NCT04631705|Drug|Placebo|Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo
16406701|NCT04628988|Drug|CC-90011|Capsule
16406702|NCT04628988|Drug|Abiraterone|Tablet
16406703|NCT04628988|Drug|Prednisone|Tablet
16406704|NCT04626986|Procedure|microwave ablation|Microwave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer.
16406705|NCT04626986|Procedure|breast conserving surgery|The treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer.
16406708|NCT04619680|Drug|Nintedanib|150 mg PO twice a day, taken with food
16406709|NCT04619680|Drug|Placebo|placebo equivalent given twice a day
16406710|NCT04617756|Drug|Patients receiving neoadjuvant therapy before radical nephrectomy|Chemotherapy using either a combination of Gemcitabine/Cisplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736) or Chemotherapy with either Gemcitibine/Carboplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736)
16406711|NCT04616066|Other|Dates|The effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
16406712|NCT04616066|Other|Raisins|The effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
16406713|NCT04615338|Other|no intervension|no intervention needed just observation and description
16406714|NCT04612244|Device|FARAPULSE Pulsed Field Ablation System|Ablation using the FARAPULSE Pulsed Field Ablation System
16406715|NCT04612244|Device|RadioFrequency and Cryoballoon Ablation|Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
16406716|NCT04609566|Drug|brentuximab vedotin|1.8 mg/kg given into the vein (IV; intravenously) every 3 weeks
16406717|NCT04609566|Drug|pembrolizumab|200 mg given intravenously every 3 weeks
16406718|NCT04603495|Drug|CPI-0610|"Double-blind treatment (CPI-0610 or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days).
~CPI-0610 is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF."
16406719|NCT04603495|Drug|Ruxolitinib|Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.
16406723|NCT04601584|Biological|GNR-084, 1 ng/kg|1 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16407000|NCT04262895|Drug|TTI-0102|TTI-0102 is a cysteamine precursor.
16406724|NCT04601584|Biological|GNR-084, 4 ng/kg|4 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16406725|NCT04601584|Biological|GNR-084, 20 ng/kg|20 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16406726|NCT04601584|Biological|GNR-084, 60 ng/kg|60 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles
16406727|NCT04601311|Behavioral|Guided self-determination|"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'….
~The goal is registered.
~Patients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2.
~A relative may take part in one session completing an analogue reflection sheet as preparation.
~Participants continue usual care."
16406728|NCT04601311|Behavioral|Personal support in goal-pursuing|"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'….
~The goal is registered.
~Patients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session.
~Participants continue usual care."
16406732|NCT04597086|Other|Best Practice|Receive standard of care
16406733|NCT04597086|Procedure|Bright White Light Therapy|Receive BWLT
16406734|NCT04597086|Other|Survey Administration|Ancillary studies
16406735|NCT04596631|Drug|Oral semaglutide|Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
16406736|NCT04596631|Drug|Placebo (semaglutide)|Placebo treatment for 52 weeks.
16406737|NCT04596501|Other|Early and late postmenopausal women|The intervention involves supervised team sports 1 h 3 x/week for 16 weeks.
16406738|NCT04592536|Drug|CVL-865 High dose|High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)
16406739|NCT04592536|Drug|Alprazolam 1mg XR|Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)
16406740|NCT04592536|Drug|Placebo|Placebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)
16406741|NCT04592536|Drug|CVL-865 low dose|Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)
16406742|NCT04585854|Other|Caffeine|Consumption of 3 shots of espresso
16406743|NCT04583969|Biological|Lenzilumab|Lenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity.
16406744|NCT04583969|Other|Placebo|Placebo for lenzilumab is commercially sourced 0.9% sodium chloride.
16406745|NCT04583969|Drug|Remdesivir|Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
16406746|NCT04583579|Device|DMV inserter (DMV® MagicTouch™) with an open end|This is a device used to help apply scleral lenses.
16406747|NCT04583579|Device|DMV inserter (DMV® MagicTouch™) with a closed end|This is a device used to help apply scleral lenses.
16406748|NCT04583579|Device|Three fingers (Patient's Hand)|This is a device used to help apply scleral lenses.
16406749|NCT04583579|Device|O-ring (Hardware Store Product)|This is a device used to help apply scleral lenses.
16406750|NCT04583579|Device|Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)|This is a device used to help apply scleral lenses.
16406751|NCT04582981|Drug|Fruquintinib and raltitrexed|Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w
16406752|NCT04582981|Drug|Fruquintinib|Fruquintinib 5mg qd monotherapy
16406753|NCT04579380|Drug|tucatinib|300 mg orally twice daily
16406754|NCT04579380|Drug|trastuzumab|Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1
16406755|NCT04579380|Drug|fulvestrant|Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.
16406756|NCT04579042|Procedure|cartilaginous batten graft septoplasty|septoplasty using cartilaginous batten graft in cases with caudal septal deviation
16406786|NCT04547868|Other|Coffee|Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of coffee will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.
16406757|NCT04575610|Drug|PF-06650833|Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). Subjects for whom concomitant administration of a strong inhibitor of cytochrome P450 (CYP) 3A4 will have the dose of the IR formulation to 200 mg once daily (QD). Subjects who can take tablets PO will receive 400 mg PF-06650833 (2-200 mg tablets) of the MR formulation QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). No dose adjustment is needed for subjects taking the MR tablet preparation, except if co-administered with ritonavir in which case the dose should be reduced to 200 mg MR QD. All dosing of PF-06650833 will be in addition to current hospital SOC therapy.
16406758|NCT04575610|Drug|Placebo|Matching placebo tablets will be administered.
16406759|NCT04572789|Dietary Supplement|Omega-3 polyunsaturated fatty acids|All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
16406760|NCT04572789|Dietary Supplement|omega-6 PUFAs|All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.
16406762|NCT04569032|Drug|brentuximab vedotin|1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
16406763|NCT04569032|Drug|cyclophosphamide|750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
16406764|NCT04569032|Drug|doxorubicin|50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
16406765|NCT04569032|Drug|prednisone|100 mg daily administered orally on Days 1-5 of each cycle
16406768|NCT04565665|Other|Best Practice|Receive standard of care
16406769|NCT04565665|Biological|Mesenchymal Stem Cell|Given IV
16406770|NCT04564963|Other|Cryotherapy|Application of cryotherapy (e.g. ice in resealable zipper storage bags, gel packs, ice packs) over largest closed incision in the post-operative period every 4 hours, at minimum, for up to 72 hours (while participant is awake and admitted to hospital). The cryotherapy should not be placed in direct contact with skin.
16406771|NCT04562220|Other|Routine conventional physical therapy plus Vibration session|Routine conventional physical therapy will be applied to patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, right after the sessions, 3 days a week, 30 Hz. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest.
16406772|NCT04562220|Other|Routine conventional physical therapy|Routine conventional physical therapy will be applied to the control group in 4 weeks and 60 minute sessions
16406773|NCT04560998|Drug|Semaglutide|Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
16406774|NCT04560998|Drug|Placebo (semaglutide)|Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
16406775|NCT04559256|Diagnostic Test|Cardiopulmonary Exercise Testing|Patients will receive a cardiopulmonary exercise testing before and 3-month after tricuspid intervention
16406776|NCT04558125|Drug|TNKase|Tenecteplase (0.25 mg/kg) supplied by Genentech, Inc. as a sterile, lyophilized powder, diluted with 10mL sterile water.
16406777|NCT04558125|Drug|Placebo|Placebo to match supplied by Genentech, Inc. as a sterile, lyophilized powder, diluted with 10mL sterile water.
16406778|NCT04558125|Drug|Enoxaparin|All participants must also receive standard of care anticoagulation therapy.
16406779|NCT04551495|Drug|Entrectinib|Entrectinib is administered orally at a dose of 600 mg once a day from days 1 to 28 of a 28-day cycle for four cycles
16406780|NCT04551495|Drug|Letrozole|Letrozole is administered orally at a dose of 2.5 mg once a day from days 1 to day 28 of a 28 day cycle for four cycles
16406781|NCT04551495|Drug|Goserelin|Goserelin is administered subcutaneously at a dose of 3.6 mg at the beginning of each cycle for 4 monthly cycles to pre-menopausal women
16406784|NCT04548661|Procedure|Intraoperative incisional wound irrigation with povidone-iodine solution|Participants will have the open incision or laparoscopic extraction site irrigated once with povidone-iodine diluted in 0.9% sterile normal saline (to a final concentration of 5% povidone-iodine (0.5% available iodine)) delivered through a bulb syringe. The povidone-iodine irrigation should be left on for 60 seconds and then dried with sterile gauze. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.
16406785|NCT04548661|Procedure|Intraoperative incisional wound irrigation with saline|Participants will have the open incision or laparoscopic extraction site irrigated once with 0.9% sterile normal saline delivered through a bulb syringe. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.
16406829|NCT04499248|Drug|AGN-193408 SR|An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.
16406830|NCT04499248|Other|Lumigan|Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
16406831|NCT04499248|Other|Sham Administration|Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
16406787|NCT04547868|Other|Decaffeinated Coffee|Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of decaffeinated coffee will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.
16406788|NCT04547868|Other|Warm water|Once the surgical team deems it appropriate to begin a clear liquid diet (in the post-operative period), approximately one cup of warm water will be provided to the patient three times daily. Additives such as cream, milk, sweetener and sugar, will be permitted. The intervention(s) will continue until a change is required as per the treating team or until hospital discharge. Patients will be asked to avoid any additional caffeine intake, such as tea, for the duration of the trial. If a patient receives an NG tube or is placed NPO by the treating team, the intervention will be halted and restarted once a clear liquid diet is restarted. All other aspects of the patients' care will be at the discretion of the treating team as per their standard practices.
16406789|NCT04546711|Other|Ketogenic Diet|The ketogenic diet (KD) is a high fat, very low carbohydrate diet
16406790|NCT04545580|Drug|Placebo|Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)
16406791|NCT04545580|Drug|BAY1817080|BAY1817080 will be taken twice daily orally as tablet(s)
16406792|NCT04542850|Dietary Supplement|5-ALA-Phosphate + SFC (5-ALA + SFC)|"Moderately ill hospitalized patients will receive:
~250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) two times daily (resulting in 500 mg 5-ALA-Phosphate and 286.8 mg SFC (30.4 mg as Fe) daily) for 7 days, then 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) once daily for 21 days
~Severely ill hospitalized patients will receive:
~250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) three times daily (resulting in 750 mg 5-ALA-Phosphate and 430.2 mg SFC (45.6 mg as Fe) daily) for 7 days, then 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) once daily for 21 days"
16406793|NCT04542317|Behavioral|REACH VN|4-6 sessions delivered over the course of 2-3 months.
16406794|NCT04542317|Behavioral|Enhanced control|A single session providing education about dementia
16406808|NCT04529980|Dietary Supplement|Lactobacillus rhamnosus GG (LGG) Probiotic|Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.
16406809|NCT04529980|Dietary Supplement|Placebo|Placebo
16406810|NCT04526977|Diagnostic Test|Immune response study|"ACE2 and CD26 receptor study
~Cytokine profile: Quantification of plasma cytokine levels
~SARS-CoV-2 CD4/CD8 T cell response
~TLR7/8 activation
~KIR characterization"
16406811|NCT04522154|Diagnostic Test|Magnet resonance imaging|Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure
16406812|NCT04521699|Device|CalmioGO Stress management device|CalmiGo device is a device of similar size to an inhaler that uses guided breathing, and grounding techniques to regulate breathing to bring users a sense of calm and relaxation.
16406813|NCT04521361|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Drug will be administered as aqueous solution intravenously at a dose of 55 kBq/kg body weight every 4 weeks for 6 cycles (cycle length = 4 weeks).
16406814|NCT04519619|Drug|Aflibercept (Eylea, BAY86-5321)|Administration by intravitreal injection
16406815|NCT04510701|Other|videoscope|a videoscope will be used to evaluate the integrity of the membrane while doing lateral maxillary sinus elevation surgery
16406816|NCT04508933|Device|Extravascular Lung Water Index|Measurement of the EVLWI
16406817|NCT04508933|Device|Pulmonary Vascular Permeability Index|Measurement of the PVPI
16406818|NCT04504669|Drug|AZD8701|FOXP3 antisense oligonucleotide
16406819|NCT04504669|Biological|Durvalumab|anti PDL-1 monoclonal antibody
16406820|NCT04504240|Drug|Famotidine 20 MG|Famotidine; tablet Famotac 20mg oral form.
16406821|NCT04501978|Biological|LY3819253|Participants are no longer being randomized to this intervention.
16406822|NCT04501978|Drug|Placebo|Commercially available 0.9% sodium chloride solution. Administered by IV infusion
16406823|NCT04501978|Biological|Remdesivir|Provided to all study participants as SOC unless contraindicated for an individual patient.
16406824|NCT04501978|Biological|VIR-7831|Participants are no longer being randomized to this intervention.
16406825|NCT04501978|Biological|BRII-196/BRII-198|Participants are no longer being randomized to this intervention.
16406826|NCT04501978|Biological|AZD7442|600 mg AZD7442 (300 mg AZD8895 + 300 mg AZD1061). Administered by IV infusion as a single dose.
16406827|NCT04501978|Drug|MP0420|600 mg. Administered by IV infusion as a single dose
16406828|NCT04501978|Drug|PF-07304814|250 mg per day for 5 days. Administered as a constant rate intravenous infusion
16406832|NCT04499248|Other|Lumigan Vehicle|Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
16407001|NCT04262895|Drug|Placebo|Placebo
16406833|NCT04492306|Other|Dimethyl Sulfoxide|DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
16406834|NCT04492306|Other|3M ESPE Single bond 2|Total etch adhesive bond
16406835|NCT04492306|Other|Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)|Composite Resin
16406836|NCT04492306|Other|3m ESPE etch|32% phosphoric acid
16406837|NCT04487548|Other|Remote smoking cessation bundle|"The bundle is a remote version of what has previously been described in prior literature, which includes:
~A brief (<5 minutes) advice
~Preoperative smoking cessation video prepared by QuitNow
~Patients will be provided brochures on smoking cessation
~A referral will be faxed (or internet-registered) to the Quitnow.ca Smokers' Helpline
~All patients will be requested to participate in the provincial Smoking Cessation program that provides a free 12-week supply of NRT once per year."
16406838|NCT04484220|Device|Ellipsys Vascular Access System|The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
16406839|NCT04476784|Device|Lehfilcon A contact lenses|Investigational silicone hydrogel contact lenses
16406840|NCT04476784|Device|Comfilcon A contact lenses|Commercially available silicone hydrogel contact lenses
16406841|NCT04476784|Device|CLEAR CARE|Hydrogen peroxide-based cleaning and disinfecting solution
16406842|NCT04471038|Biological|SAB-176|Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
16406843|NCT04471038|Other|Normal Saline|Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
16406844|NCT04470063|Drug|DDO-3055 tablets|Multi-dose for DDO-3055 tablets
16406845|NCT04470063|Drug|Placebo|Multi-dose for Placebo
16406846|NCT04469179|Biological|SAB-185|SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
16406847|NCT04469179|Other|Normal Saline|Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
16406848|NCT04468958|Biological|SAB-185|SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
16406849|NCT04468958|Other|Normal saline|Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
16406850|NCT04466475|Biological|Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10|Given IV
16406851|NCT04466475|Drug|Melphalan|Given via infusion
16406852|NCT04466475|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplantation
16406853|NCT04464304|Device|Smartphone|Patients will participate in a similar game to the VR cohort, but will use a smartphone device.
16406854|NCT04464304|Device|Virtual Reality (Oculus Quest)|Patients will participate in a game using VR.
16406855|NCT04462497|Other|Prototype device|Patients will receive the prototype head and neck support device to be used intraoperatively.
16406856|NCT04459052|Dietary Supplement|N acetyl cysteine|Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
16406857|NCT04459052|Drug|[F-18] Fluorodopa Positron Emission Tomography|FDOPA PET diagnostic imaging to to measure dopamine function, serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 months.
16406858|NCT04454476|Drug|Trametinib treatment|1 mg taken by mouth once a day for 14 days
16406859|NCT04454476|Procedure|Endoscopy|A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.
16406863|NCT04444700|Drug|Therapeutic anticoagulation|The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
16406864|NCT04442503|Drug|SAGE-217|SAGE-217 oral capsules.
16406865|NCT04442503|Drug|Placebo|SAGE-217 matched-placebo oral capsules.
16406866|NCT04435379|Biological|VPM1002|The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
16406867|NCT04435379|Biological|Placebo|The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
16406868|NCT04434417|Device|2019-nCoV IgG/IgM Rapid Test Cassette|The specimen (whole blood, serum, plasma) will be loaded into the cassette and will migrate via capillary action along the membrane to react with the gold conjugate. The result will be available in 10 minutes
16406869|NCT04430036|Drug|AGEN1884|A fully human monoclonal Anti-PD-1 Antibody
16406870|NCT04430036|Drug|AGEN2034|A fully human monoclonal Anti-PD-1 Antibody
16406873|NCT04429854|Biological|Convalescent Plasma|"4 units of convalescent plasma:
~2 units of plasma are administered within 12h after randomization, but preferably as soon as practically possible
~2 units of plasma should be administered between 24h and 36h after the first infusion
~Other investigational products may be added as part of the adaptive study design."
16406874|NCT04429854|Drug|Standard of care|Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.
16406875|NCT04429802|Drug|Prucalopride|Orally administered
16406876|NCT04429802|Drug|Placebo|Orally administered
16406877|NCT04428190|Dietary Supplement|Human Milk Oligosaccharides (HMO)|Sachet containing 10 grams of HMO
16406878|NCT04428190|Other|Placebo|Sachet manufactured to mimic 10g of HMO
16406879|NCT04426461|Behavioral|Behavioral Activation|Behavioral activation will be delivered as a 10-week, manualized, behavioral intervention focused on enhancing engagement in meaningful and reinforcing activities.
16406880|NCT04426461|Behavioral|Exposure-based therapy|Exposure-based therapy will be delivered as a 10-week, manualized, behavioral intervention focused on decreasing avoidance to allow for inhibitory learning and challenging negative expectations.
16406881|NCT04426461|Behavioral|Supportive therapy|Supportive therapy will be delivered as a 10-week, manualized intervention focused on encouraging patients to talk openly about their thoughts, emotions, and any past or current concerns.
16406882|NCT04415515|Behavioral|RN case management|A Registered Nurse (RN) case manager makes phone contact with the member to review medications, health risks, care gaps/barriers, & to develop a case management plan that focuses on improving medication adherence & reconciliation, condition-based measures & outcomes, addressing psycho-social needs, & intensive post-admission care transition. RNs may refer the member to social workers,specialist providers, & support programs (including to more intense case management where the primary care physician is notified that RNs may contact them to support treatment & coordinate services).
16406883|NCT04415515|Behavioral|Community Health Worker Case Management|In selected UHC markets for defined time periods, members randomized to the treatment arm also received an enhanced version of the SCC that included in-home case management support from non-clinical Community Health Workers (CHW).
16406884|NCT04415515|Behavioral|RN Standard care coordination and disease management|RN Standard care coordination and disease management
16406885|NCT04415372|Diagnostic Test|MRI|The MRI protocol will include conventional testing for MS lesion detection and functional MR imaging to localize associated neurocognitive domains in each subject.
16406886|NCT04415372|Diagnostic Test|Neuropsychological Testing|A comprehensive battery of neuropsychological tests will be administered to assess memory, new learning, spatial processing and higher executive function.
16406887|NCT04410900|Biological|Wistar Rabies Virus Strain PM-1503-3M Vaccine|Given IM
16406888|NCT04410900|Procedure|Biospecimen Collection|Undergo collection of blood samples
16406890|NCT04406441|Behavioral|Patient Reported Outcome Well Child Visit|Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.
16406891|NCT04406441|Behavioral|Patient Reported Outcome Well Child Visit + Food Care|Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.
16406892|NCT04404283|Drug|Brentuximab vedotin|1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
16406893|NCT04404283|Drug|Rituximab|375 mg/m^2 administered via intravenous infusion on Cycle 1 Day 1. 1400 mg injected under the skin (subcutaneous) permitted every 3 weeks from Cycle 2 Day 1 through end of treatment.
16406894|NCT04404283|Drug|Lenalidomide|20 mg given by mouth (orally) daily
16406895|NCT04404283|Other|Placebo|Administered via intravenous infusion every 3 weeks
16406896|NCT04402827|Diagnostic Test|Susceptibility to infection|"ACE2 and CD26 receptor study: After genomic DNA extraction and quantification using a NanoDrop-1000, 14 ACE2 SNPs (rs1978124, rs2048683, rs2074192, rs2106809, rs2285666, rs233575, rs4240157, rs4646142, rs4646155, rs4646156, rs4646188, rs4830542, rs6632677, and rs879922) will be studied. In addition, one CD26 (DPP4) SNP (rs7608798) will be analysed (qualitative measure).
~SARS-CoV-2 CD4/CD8 T cell response: SARS-CoV-2 peptides (Prot-S, Pros-N and Port-M) will be used to activate CD4 and CD8 T cells. Cytokines released, such as IFNg, TNFa, IL4, IL17A, and IL2, from each cell subset will be measured by flow cytometry (quantitative measure).
~KIR characterization: Characterization of the presence of 14 genes plus 2 pseudogenes of KIR gene family (qualitative genotyping) by PCR, mRNA expression profiling (quantitative measures) by RT-PCR, and phenotyping of human NK cells analyzing different KIR receptors (quantitative measure) by flow cytometry, will be analyzed."
16406899|NCT04396860|Biological|Ipilimumab|Given IV
16406900|NCT04396860|Biological|Nivolumab|Given IV
16406901|NCT04396860|Device|NovoTTF-100A Device|Wear Optune device
16406902|NCT04396860|Other|Quality-of-Life Assessment|Ancillary studies
16406903|NCT04396860|Other|Questionnaire Administration|Ancillary studies
16406904|NCT04396860|Radiation|Radiation Therapy|Undergo radiation therapy
16406905|NCT04396860|Drug|Temozolomide|Given PO
16406906|NCT04387760|Drug|Hydroxychloroquine|"400mg BID PO day 1 then 200mg BID PO from day 2 to day 10.
~In addition to Hydroxychloroquine all patients will receive the standard care (according to local Bahrain COVID19 guidelines). Any patient who is fit for discharge, can be discharged and medications will be stopped on discharge."
16406951|NCT04315246|Biological|radiolabeled DPTA-omburtamab|Biological, radiolabeled DPTA-omburtamab
16406907|NCT04387760|Drug|Favipiravir|"1600mg BID PO day 1600mg BID PO day 2 to day 10.
~In addition to Favipiravir all patients will receive the standard care (according to local Bahrain COVID19 guidelines). Any patient who is fit for discharge, can be discharged and medications will be stopped on discharge."
16406908|NCT04387760|Other|Routine care for COVID-19 patients|Supportive care according to local guidelines
16406916|NCT04374903|Drug|HCQ & AZ vs HCQ+SIR|Subjects will receive either Hydroxychloroquine with Azithromycin or Hydroxychloroquine with Sirolimus
16406922|NCT04365803|Procedure|vacuum-assisted breast biopsy|patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery
16406923|NCT04362085|Drug|Therapeutic Anticoagulation|The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
16406924|NCT04356534|Other|plasma therapy using convalescent plasma with antibody against SARS-CoV-2|convalescent patient plasma plus routine local standard of care
16406925|NCT04356534|Other|Routine care for COVID-19 patients|local standard of care which include antivirals and supportive care
16406926|NCT04354597|Drug|HCQ & AZ|Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
16406927|NCT04351750|Other|general exercise|The participants will receive training sessions twice a week for 8 weeks. General exercise includes aerobic exercise (stationary bike) and resistance training (thera-band, sandbags, dumbbell and swiss ball), and the intensity and progression of both aerobic and resistance exercises will be provided as recommended by the ACSM, and the exercise will individualized based on participant's HRR, 1 RM weight and Borg Scale of Perceived Exertion Scale (Borg RPE scale). An oximeter will be utilized to monitor the heart rate and SPO2 of the participants to ensure safety during the training session.
16406928|NCT04351750|Other|pelvic floor muscle training|Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set.
16406929|NCT04340193|Biological|nivolumab|specified dose on specified days
16406930|NCT04340193|Biological|ipilimumab|specified dose on specified days
16406932|NCT04338555|Procedure|Transcutaneous electrical acupoint stimulation|TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.
16406933|NCT04333576|Drug|Elagolix|Tablet:Oral
16406934|NCT04333576|Drug|Combined Oral Contraceptive (COC)|Tablet:Oral
16406935|NCT04333576|Drug|Placebo for Elagolix|Tablet:Oral
16406936|NCT04333576|Drug|Placebo for COC|Capsule:Oral
16406937|NCT04333576|Drug|Combined Oral Contraceptive (COC)|Capsule:Oral
16406938|NCT04331756|Procedure|Guiding Emergence From Anaesthesia With Tragus Pressure|Use of tragus pressure in guiding patients from emergence from anaesthesia post-surgery
16406939|NCT04331756|Procedure|Guiding Emergence From Anaesthesia Without Tragus Pressure|Usual clinical routine practice in guiding patients from emergence from anaesthesia post-surgery
16406940|NCT04325789|Device|nanofiber scaffold|Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.
16406941|NCT04320342|Drug|Beclomethasone Dipropionate|Available in pressurized inhalation solution BDP/GB/FF 100/6/12.5μg and BDP/FF 100/6μg
16406942|NCT04320342|Drug|Glycopyrronium Bromide|Available in pressurized inhalation solution BDP/GB/FF 100/6/12.5μg
16406943|NCT04320342|Drug|Formoterol Fumarate|Available in pressurized inhalation solution BDP/GB/FF 100/6/12.5μg and BDP/FF 100/6μg
16406944|NCT04320030|Drug|[18F]-DPA-714 PET/CT scan|Pretherapeutic [18F]-DPA-714 PET/CT scan
16406948|NCT04316117|Procedure|Computed Tomography|Undergo PET/CT
16406953|NCT04313881|Drug|Azacitidine|Administered either subcutaneously (SB) or intravenously (IV) according to region-specific drug labeling
16406954|NCT04313881|Drug|Placebo|Placebo to match magrolimab administered intravenously
16406955|NCT04310592|Biological|CYNK-001|CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
16406958|NCT04305795|Biological|200 mg Pembrolizumab|IV on Day 1 of each 3-week cycle for up to 24 months
16406959|NCT04305795|Biological|Cemiplimab 350mg|Photoimmunotherapy Light Treatment
16406960|NCT04305795|Combination Product|ASP-1929|IV on Day 1 of each 3-week cycle for up to 24 months
16406961|NCT04304534|Drug|BAY2433334|Tablet, taken orally once a day.
16406962|NCT04304534|Other|BAY2433334 matching placebo|Tablet, taken orally once a day.
16406963|NCT04300244|Biological|UV1 vaccine + leukine|The mode of action of UV1 is to activate the immune system to induce T cells directed against telomerase (hTERT). UV1 vaccination amplifies the pool of hTERT specific tumor-reactive T cells from the naive repertoire and has the potential to increase the breadth and diversity of the tumor-reactive T cell response (epitope spreading). Vaccination with UV1 can thus provide the basis for increased efficacy of checkpoint inhibition therapy, by augmenting the pool of tumor specific T cells in patients with limited or insufficient numbers of T cell clones spontaneously primed by tumor antigens. Reciprocally, the efficacy of UV1 vaccination may be enhanced in combination with checkpoint inhibitors, since the clonal expansion and effector activity of UV1 induced T cells will otherwise be restricted by intrinsic immune regulatory and tumor induced suppressor mechanisms.
16406964|NCT04300244|Biological|ipilimumab|The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.
16406965|NCT04300244|Biological|nivolumab|The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.
16406966|NCT04298203|Drug|Phentermine-Topiramate|The study medication to be tested for this study is a combination of phentermine and topiramate.
16406967|NCT04298203|Dietary Supplement|Meal Replacement Therapy|The first six weeks of the study, subjects will receive meal replacement therapy in an effort to reduce their BMI by at least 5%.
16406968|NCT04298203|Other|Placebo|A pill that looks like Phentermine-Topiramate but has no active medication.
16406969|NCT04297917|Biological|ChAdOx1-HBV|chimpanzee adenovirus-vectored hepatitis B virus vaccine
16406970|NCT04289779|Drug|Cabozantinib|Cabozantinib 40 mg orally daily for 3 cycles
16406971|NCT04289779|Drug|Atezolizumab|Atezolizumab 1200 mg IV every 3 weeks for 3 cycles
16406972|NCT04289779|Procedure|Cystectomy|Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.
16406973|NCT04286139|Behavioral|SHAPE|The SHAPE intervention provides information for carers, and maintains the dignity and autonomy of the person with dementia, supporting them in planning for the future with their family. The person with dementia attends an online 10 week facilitator lead group based course. It is designed to develop self-management skills in areas including decision-making, symptom management and social interaction. It also provides information on the disease process and the development of healthy behaviors in a supportive learning environment to prevent problems that are common in the later stages of the disease. The adjunctive e-learning platform for carers provides the same information that the person with dementia receives plus additional material and signposting to support them in their role. This will empower the whole family to support and enable more effective self-management by the person with dementia, and enhance their ability to plan ahead together and make key decisions jointly.
16406974|NCT04281485|Genetic|PF-06939926|PF-06939926 will be administered as a single IV infusion at Year 1 for Cohort 1.
16406975|NCT04281485|Other|Placebo|Placebo will be administered as a single IV infusion at Year 1 for Cohort 2.
16406976|NCT04281485|Other|Placebo|Placebo will be administered as a single IV infusion at Year 2 for Cohort 1.
16406977|NCT04281485|Genetic|PF-06939926|PF-06939926 will be administered as a single IV infusion at Year 2 for Cohort 2
16406978|NCT04279522|Device|Relivion®DP- Active|Relivion®DP- Active stimulation device
16406979|NCT04279522|Device|Relivion®DP- Sham|Relivion®DP- Sham stimulation device
16406980|NCT04275999|Drug|ivermectin|Subjects will be given the ivermectin with an electronic monitoring device attached with a return appointment at month 3 for end of study visit. Subjects will be instructed to use the ivermectin once daily.
16406981|NCT04275999|Behavioral|digital interaction|Subjects will receive weekly digital interaction; an electronic survey asking about their use of the ivermectin which will have the electronic monitoring device attached. Subjects will be instructed to use the ivermectin once daily. They will have a 3 month return appointment for end of study visit.
16406982|NCT04275999|Device|GPSkin|Subjects in the GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin with the electronic monitoring device once daily. They will be scheduled for a 3 month end of study visit.
16406983|NCT04274751|Device|Transcatheter aortic valve implantation|Transcatheter aortic valve implantation
16406988|NCT04269889|Drug|Eltrombopag|150 mg/day starting dose (titration and adjustments for age and ethnicity)
16406989|NCT04267939|Drug|BAY1895344|BAY1895344 will be administered BID (twice daily) in a 28 day-cycle.
16406990|NCT04267939|Drug|Niraparib|Niraparib will be administered orally once daily continuously throughout the cycle.
16407004|NCT04256369|Combination Product|Parenteral Nutrition (PN) Premixed Olimel N9E|Parenteral nutrition
16407005|NCT04254107|Drug|SEA-TGT|Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
16407006|NCT04254107|Drug|sasanlimab|Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle
16407007|NCT04245475|Behavioral|Virtual Reality psychological pain reduction|attention distraction
16407008|NCT04242602|Device|Transcranial Doppler|Record flow velocity tracing of middle cerebral artery using a transcranial doppler.
16407009|NCT04235907|Other|Telerehabilitation|Internet-guided rehabilitation with weekly phone calls from a physical therapist.
16407010|NCT04235907|Other|Standard rehabilitation|Prescription for physical therapy and a printed list of exercises to complete.
16407011|NCT04228731|Procedure|Outpatient|Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty
16407012|NCT04228731|Procedure|Inpatient|Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty
16407013|NCT04214418|Drug|Cobimetinib|(40-60 mg) orally once daily (morning) on days 1-21 of each 28-day selective small molecule inhibitor for MEK1 and MEK2
16407014|NCT04214418|Drug|Hydroxychloroquine|(600mg) orally twice daily on days 1-28 of each 28-day cycle
16407015|NCT04214418|Drug|Atezolizumab|840 mg IV on Days 1 and 15 of each cycle humanized IgG1 monoclonal antibody (MAb)
16407016|NCT04214067|Radiation|Brachytherapy|Undergo vaginal brachytherapy
16407017|NCT04214067|Radiation|External Beam Radiation Therapy|Undergo EBRT
16407018|NCT04214067|Biological|Pembrolizumab|Given IV
16407019|NCT04214067|Other|Quality-of-Life Assessment|Ancillary studies
16407020|NCT04214067|Other|Questionnaire Administration|Ancillary studies
16407021|NCT04207931|Drug|Topical steroid class I-II|applied once daily - 18 month duration of the study
16407022|NCT04207931|Drug|Triamcinolone Acetonide|Intralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections.
16407023|NCT04207931|Drug|Doxycyline|oral antibiotic twice daily for 6 months
16407024|NCT04207931|Drug|Minoxidil|5% solution or foam started after month 8
16407025|NCT04204967|Drug|Fentanyl Transdermal System|in the experimental arm transdermal fentanyl will be administered with a starting dose of 50 mcg/hr simultaneously with the preexistent remifentanil continue infusion. Remifentanil infusion rate will be increased or decreased based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit. After randomization, the transdermal fentanyl dose can be modified every 24 hours according to the study protocol to achieve the desired effect in terms of PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected
16407026|NCT04204967|Drug|Remifentanil|"In the active comparator arm remifentanil infusion is administered alone, the infusion rate will be increased or decreased according to the study protocol based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit.
~In the experimental arm remifentanil is use together with transdermal fentanyl"
16407029|NCT04186871|Drug|branebrutinib|Specified dose on specified days
16407030|NCT04186871|Drug|abatacept|Specified dose on specified days
16407031|NCT04186871|Drug|branebrutinib placebo|Specified dose on specified days
16407032|NCT04183335|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
16407033|NCT04183335|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
16407034|NCT04183335|Drug|Moisturizers|"Pharmaceutical form:
~Route of administration: Topical"
16407035|NCT04183335|Drug|Low to medium potent topical corticosteroids|"Pharmaceutical form:
~Route of administration: Topical"
16407036|NCT04183335|Drug|Topical calcineurin inhibitors|"Pharmaceutical form:
~Route of administration: Topical"
16407037|NCT04182672|Drug|Zilretta|Subjects will be injected with the 5ml of FX006. This injection may be followed with up to 3ml of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.
16407038|NCT04180488|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
16407039|NCT04180488|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
16407040|NCT04180488|Drug|non sedating H1-antihistamine|Pharmaceutical form:Tablet Route of administration: oral administration
16407041|NCT04177394|Device|MitraClip G4 System|Percutaneous mitral valve repair using the MitraClip G4 system.
16407042|NCT04170985|Other|clinical Whole Genome Sequencing|Participants will receive cWGS as well as standard of care testing. The clinician/site PI will be blinded to the cWGS results until Day 180.
16407043|NCT04169373|Drug|Upadacitinib|Upadacitinib is administered as oral tablet
16407044|NCT04169373|Drug|Placebo|Placebo for upadacitinib is administered as oral tablet
16407045|NCT04167618|Drug|177Lu-DTPA-omburtamab|Biological, radiolabeled DPTA-omburtamab
16407046|NCT04166409|Drug|Carboplatin|Given IV
16407047|NCT04166409|Other|Quality-of-Life Assessment|Ancillary studies
16407048|NCT04166409|Other|Questionnaire Administration|Ancillary studies
16407049|NCT04166409|Drug|Selumetinib Sulfate|Given PO
16407050|NCT04166409|Drug|Vincristine Sulfate|Given IV
16407053|NCT04157088|Drug|Darolutamide(Nubeqa, BAY1841788)|600mg, twice daily
16407054|NCT04157088|Drug|Enzalutamide|160mg, once daily
16407055|NCT04143035|Other|No Intervention|No Intervention
16407056|NCT04142619|Biological|UCARTCS1A|Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor
16407677|NCT02339571|Biological|Ipilimumab|Given IV
16407057|NCT04132973|Behavioral|Compassion for Skin Conditions|Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
16407058|NCT04131439|Diagnostic Test|Computed Tomography and Magnetic resonance imaging|Preoperative imaging for patients undergoing cochlear implants
16407059|NCT04130919|Drug|Tilpisertib|Tablets administered orally once daily
16407060|NCT04130919|Drug|Placebo|Tablets administered orally once daily
16407061|NCT04113746|Behavioral|Better asthma self-management and incorporation of physical activity|Participants in the asthma and exercise lifestyle change arm will participate in 4 sessions focused on behavioral change and goal-setting education to teach them how to better incorporate exercise into their daily lives and better manage their asthma. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
16407062|NCT04113746|Behavioral|Asthma Education|General asthma education, but no discussion of the role of exercise and other lifestyle habits in asthma self-management. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
16407063|NCT04110613|Dietary Supplement|noFast: Start tube feeds within 1 hour of procedure|Earliest possible initiation of tube feeding after bedside PEG tube procedure.
16407064|NCT04101461|Drug|Iron|PharaFerro27; Devart Lab Company, Egypt
16407065|NCT04101461|Diagnostic Test|Complete blood count|to assess the anemia
16407066|NCT04101461|Diagnostic Test|Serum ferritin|to assess the anemia
16407067|NCT04098224|Device|smART+ System|Utilizing the smART+ System to provide feeding optimization to the patient
16407068|NCT04095364|Drug|Carboplatin|Given IV
16407069|NCT04095364|Drug|Letrozole|Given PO
16407070|NCT04095364|Drug|Paclitaxel|Given IV
16407071|NCT04094246|Procedure|Battlefield Acupuncture|Battlefield Acupuncture (BFA), an auricular acupuncture protocol developed in 2001 by Dr. Niemtzow (Ret. Colonel, USAF), is widely used among civilian and military medical providers to treat pain. Participants in the Experimental Group will receive BFA in addition to standard post-surgical rehabilitation up to four times following their shoulder surgery: 24-hours, 48-hours, 72-hours, and 1-week post-surgery.
16407072|NCT04094246|Procedure|Standard post-surgical rehabilitation|Participants will receive rehabilitation and will perform a home exercise program in accordance with the standard post-operative shoulder protocol. Participants will be asked to record compliance on an exercise log.
16407073|NCT04093323|Biological|Alpha-type-1 Polarized Dendritic Cells|Given ID
16407074|NCT04093323|Drug|Celecoxib|Given PO
16407075|NCT04093323|Drug|PD-1 Ligand Inhibitor|Given IV
16407076|NCT04093323|Drug|PD1 Inhibitor|Given IV
16407077|NCT04093323|Biological|Recombinant Interferon Alfa-2b|Given IV
16407078|NCT04093323|Drug|Rintatolimod|Given IV
16407079|NCT04089566|Drug|Nusinersen|Administered as specified in the treatment arm
16407084|NCT04085458|Drug|Damoctocog alfa pegol (Jivi, BAY94-9027)|The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion.
16407085|NCT04085445|Device|AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter|To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.
16407086|NCT04080804|Drug|Nivolumab|A fully human anti-programmed death 1 (PD-1) monoclonal antibody checkpoint inhibitor, that blocks a signal that prevents activated T cells from attacking the cancer cells.
16407087|NCT04080804|Drug|Relatlimab|A monoclonal antibody with anti-Lymphocyte-activation gene 3 (LAG-3) (immune checkpoint receptor protein found on the cell surface) activity.
16407088|NCT04080804|Drug|Ipilimumab|A monoclonal anitibody that targets CTLA-4, a protein receptor, that down regulates the immune system.
16407089|NCT04072588|Procedure|vaginal cuff prolapse surgery|Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes
16407090|NCT04069273|Drug|Pembrolizumab Monotherapy|Pembrolizumab 200 mg IV
16407091|NCT04069273|Drug|Ramucirumab|Ramucirumab 8 mg/kg IV
16407092|NCT04069273|Drug|Paclitaxel|Paclitaxel 80 mg/m2 IV
16407093|NCT04059393|Other|Internet-Based Intervention|Complete web-based legacy intervention
16407094|NCT04059393|Other|Best Practice|Receive standard of care
16407095|NCT04059393|Other|Quality-of-Life Assessment|Ancillary studies
16407096|NCT04059393|Other|Questionnaire Administration|Ancillary studies
16407097|NCT04058652|Device|transcutaneous electrical nerve stimulation (TENS) unit|The transcutaneous electrical nerve stimulation (TENS) unit is a noninvasive, inexpensive, battery-operated device that was originally designed to provide modulation of the afferent nervous system to relieve pain. By providing alternating current through cutaneous electrodes, TENS activates large-diameter afferent fibers of the nervous system (A-delta, A-beta, C fibers), whose ascending signals are subsequently relayed to the central nervous system.
16407101|NCT04052568|Drug|Psilocybin|Participants will undergo up to four moderate to high dose psilocybin sessions. Dosing at the first session will be 20 mg. For subsequent sessions participants will either remain at their previous dose, or increase by increments of 5 mg up to a maximum of 30 mg.
16407102|NCT04050436|Drug|Cemiplimab|Cemiplimab administered intravenously
16407103|NCT04050436|Biological|RP1|RP1 administered intratumorally
16407104|NCT04048876|Drug|CC-90001|oral
16407105|NCT04048876|Drug|Placebo|oral
16407106|NCT04048512|Procedure|Resection with intraoperative use of ECMO/CPB|Patients are operated with the use of intraoperative ECMO/CPB
16407107|NCT04048512|Procedure|Resection without intraoperative use of ECMO/CPB|Patients are operated without the use of intraoperative ECMO/CPB
16407108|NCT04046445|Drug|ATP128|5-6 SC injections
16407109|NCT04046445|Drug|BI 754091|≥ 7 IV infusions
16407110|NCT04046445|Drug|VSV-GP128|1 single IV injection
16407111|NCT04043507|Other|Sample Collection|Blood and urine samples will be collected for research purposes along with the routinely collected blood and urine samples that are collected as part of the standard of care.
16407112|NCT04031807|Procedure|Single-Incision Sling|The women with stress urinary incontinence underwent single-incision sling procedure.
16407113|NCT04017130|Drug|MT-0169|MT-0169 intravenous infusion.
16407114|NCT04015609|Behavioral|Meaning Centered Psychotherapy for Latinos|MCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span ot 7-14 weeks.
16407115|NCT04015609|Behavioral|Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale|Determines the degree of spiritual well-being
16407116|NCT04015609|Behavioral|Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients|Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.
16407117|NCT04015609|Behavioral|Pre-assessment questionnaire|Which includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.
16407118|NCT03995264|Procedure|Ultrasound -guided cannulation|radial artery cannulation using the ultrasound
16407119|NCT03995264|Procedure|Palpation -guided cannulation|radial artery cannulation using the palpation
16407120|NCT03990506|Procedure|Epi-on PiXL|Photorefractive intrastromal crosslinking (PiXL) After local anaesthetics, the keratoconus cornea is soaked in Riboflavin by repeated topical application during 10 minutes. For masking purposes, epithelial debridement is simulated by moving a scraping instrument in front of the cornea. A Riboflavin soaked sponge is used to lightly disrupt the epithelium tight junctions, without epithelium debridement. The cornea is illuminated with PiXL under 16:40 minutes during continuously delivery of humidified high oxygen via specific oxygen goggles. The UV-dosage is individually customized based upon Kmax; for < 45 Diopters (D) 7.2J/cm2 is used; for 45-50D 10J/cm2 is used; for > 50D 15 J/cm2 is used.
16407121|NCT03990506|Procedure|Epi-Off PiXL|Photorefractive intrastromal crosslinking (PiXL) After local anaesthetics, the corneal epithelium is debrided and the keratoconus cornea is soaked in Riboflavin by repeated topical application during 10 minutes. The cornea is then illuminated with individually customized PiXL under 16:40 minutes. The UV-dosage is individually customized based upon Kmax; for < 45D 7.2J/cm2 will be used; for 45-50D 10J/cm2 will be used; for > 50D 15 J/cm2 will be used.
16407122|NCT03985085|Other|Comprehensive package of sexual and reproductive health services|"Implementation of a comprehensive sexual and reproductive health care package for female sex workers in Côte d'Ivoire, combining an HIV PrEP offer (for HIV- FSW) with early treatment of HIV+ FSW, management of HBV infection (testing, vaccination and treatment), testing and treatment of sexually transmitted infections (STIs) and their consequences, a contraception offer, a quarterly screening of pregnancies, menstrual management counselling and identification of addiction.
~This healthcare package will be available both in mobile clinics organized for a quarterly follow-up (10 intervention sites, each site being visited every two weeks) and in the fixed clinic of the partner community-based NGO, at the discretion of each female participant."
16407123|NCT03976362|Biological|Pembrolizumab|IV infusion
16407124|NCT03976362|Drug|Carboplatin|IV infusion
16407125|NCT03976362|Drug|Paclitaxel|IV infusion
16407126|NCT03976362|Drug|Nab-paclitaxel|IV infusion
16407127|NCT03976362|Drug|Olaparib|Tablets
16407128|NCT03976362|Drug|Placebo|Placebo to olaparib, tablets
16407132|NCT03960645|Drug|B/F/TAF|50/200/25 mg FDC tablet administered orally once daily without regard to food
16407133|NCT03955198|Combination Product|Radiotherapy + durvalumab|Radiotherapy will be administered in combination with Durvalumab
16407134|NCT03952585|Drug|Cisplatin|Given IV
16407135|NCT03952585|Radiation|Image Guided Radiation Therapy|Undergo IGRT
16407136|NCT03952585|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16407137|NCT03952585|Biological|Nivolumab|Given IV
16407138|NCT03952585|Other|Quality-of-Life Assessment|Ancillary studies
16407139|NCT03952585|Other|Questionnaire Administration|Ancillary studies
16407140|NCT03949868|Behavioral|High Mindfulness|"Those in the high mindfulness group will also receive questions about their memory performance over the past 30 minutes in both the morning and evening for six days. In order to emphasize the variability in pain, participants will receive these text messages on a variable schedule. In addition, they will sent instructions every morning to pay attention to variability in their memory performance throughout the day and asked to report on how their memory performance is changing over time as a part of each text message prompt."
16407141|NCT03949868|Behavioral|Low Mindfulness|"Those in the low mindfulness group, who will receive receive two text messages per day (one at at 9am and one at 8pm) for six days, each prompting them to write about the activity they are currently engaged in. They will also be prompted with the 9am text to report on their memory performance over the past 30 minutes."
16407142|NCT03949868|Behavioral|Active control|"Participants in the active control group will receive 2 text messages per day for six days (one at 9am and one at 8pm) asking them to report on the activity they are currently engaged in."
16407143|NCT03949738|Diagnostic Test|Near-infrared spectroscopy-based assessement of cerebral autoregulation.|"Cerebral autoregulation is assessed using a software that calculates correlation coefficients based on the values of cerebral oxygenation (detected by near-infrared spectroscopy) and invasively measured arterial blood pressure.
~Correlation coefficients are calculated at 10-second intervals and averaged over a period of 300 seconds, resulting in an autoregulation index (cerebral oxygenation index, COx). The index can range between -1 and +1. It provides information about cerebral autoregulation capacity, with a value below 0.3 indicating intact cerebral autoregulation."
16407144|NCT03941860|Drug|Ixazomib Citrate|Given PO
16407145|NCT03941860|Drug|Lenalidomide|Given PO
16407146|NCT03941860|Other|Placebo Administration|Given PO
16407147|NCT03941860|Other|Quality-of-Life Assessment|Ancillary studies
16407148|NCT03941860|Other|Questionnaire Administration|Ancillary studies
16407149|NCT03939949|Behavioral|High Mindfulness|"Those in the high mindfulness group will also receive questions about their current pain intensity and unpleasantness in both the morning and evening for six days. In order to emphasize the variability in pain, participants will receive these text messages on a variable schedule. In addition, they will sent instructions every morning to pay attention to variability in their pain throughout the day and asked to report on how their pain is changing over time as a part of each text message prompt."
16407150|NCT03939949|Behavioral|Low Mindfulness|"Those in the low mindfulness group, who will receive receive two text messages per day (one at at 9am and one at 9pm) for six days, each prompting them to write about the activity they are currently engaged in. They will also be prompted with the 9pm text to report on their pain intensity and unpleasantness at that time."
16407151|NCT03939949|Behavioral|Active Control|"Participants in the active control group will receive 2 text messages per day for six days (one at 9am and one at 9pm) asking them to report on the activity they are currently engaged in."
16407152|NCT03937960|Other|Carbohydrate restricted group|Prescribed low carbohydrate diet with set recipes
16407153|NCT03937960|Other|Standard low fat diet|Diet with less than 20% total calorie intake from dietary fats
16407154|NCT03924947|Drug|Pancrelipase|Delayed release capsules
16407157|NCT03920267|Drug|BMS-986165|Specified dose on specified days
16407158|NCT03915496|Drug|PF-04965842 200 mg|PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
16407159|NCT03915496|Drug|PF-04965842 100 mg|PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
16407160|NCT03915496|Drug|Placebo|Placebo administered as two tablets to be taken orally once daily for 12 weeks
16407161|NCT03910660|Drug|BXCL701 plus Pembrolizumab|"BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration.
~BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set.
~BXCL701 should not be taken on an empty stomach.
~On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day.
~The PEMBRO dose will be 200 mg, administered as an IV infusion over 30 mins. on Day 1 of each 21-day cycle."
16407162|NCT03910660|Drug|BXCL701 monotherapy|"BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration.
~BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set.
~BXCL701 should not be taken on an empty stomach.
~On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day."
16407163|NCT03909971|Drug|Lorlatinib|ALK inhibitor-treated ALK-positive NSCL treatment
16407174|NCT03896581|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16407175|NCT03896581|Other|Placebo|Subjects will receive placebo at pre-specified time-points.
16407181|NCT03895203|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
16407182|NCT03895203|Drug|Adalimumab|Adalimumab will be administered according to the labeling recommendations.
16407183|NCT03895203|Other|Placebo|Subjects will receive placebo at pre-specified time-points.
16407184|NCT03888027|Behavioral|WalkMORE group|Hospitalized Internal Medicine patients will walk with trained volunteers twice daily until hospital discharge.
16407185|NCT03883542|Genetic|genomic mutations study|"Sequencing of the DNA samples extracted from the subgroups
~serous BOT tissue,
~serous BOT tissue with non-invasive implants and
~serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing
~Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)"
16407191|NCT03866382|Drug|Cabozantinib S-malate|Given PO
16407192|NCT03866382|Biological|Ipilimumab|Given IV
16407193|NCT03866382|Biological|Nivolumab|Given IV
16407198|NCT03855696|Biological|MG1113|MG1113
16407199|NCT03855696|Other|Placebo of MG1113|Placebo of MG1113
16407200|NCT03854747|Other|cervical spinal stabilization exercise|The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.
16407201|NCT03854032|Biological|Nivolumab|Given IV
16407202|NCT03854032|Biological|IDO1 Inhibitor BMS-986205|Given PO
16407203|NCT03854032|Procedure|Therapeutic Conventional Surgery|Undergo Surgery
16407204|NCT03854032|Other|Questionnaire Administration|Ancillary studies
16407205|NCT03850678|Device|Hearing Aid|Hearing Aid
16407206|NCT03844048|Drug|Venetoclax|oral; film-coated tablets or tablets for oral suspension
16407207|NCT03840967|Drug|Niraparib|Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
16407208|NCT03840837|Drug|Rivastigmine transdermal patch|Titration of transdermal rivastigmine, as per arm description.
16407209|NCT03818880|Device|Novel spectacle lens design|Spectacle lens to control progression of myopia
16407210|NCT03818763|Biological|Auto CD34+PBSC, transduced with a lentiviral vector encoding the B domain deleted from of human coagulation factor VIII|"Reduced intensity conditioning with melphalan and fludarabine, followed by a single infusion of autologous CD34+PBSC, transduced with a lentiviral vector (-889ITGA2B-BDDFVIII-WPTS(MUT6)(VSVg)) also known as (Pleightlet(MUT6)) encoding the B domain deleted from of human coagulation factor VIII (BDDFVIII) in up to five hemophilia A patients with a history of FVIII inhibitors (≥0.6BU).
~The infusion volume of transduced cells will not exceed 20 ml/kg body weight."
16407211|NCT03818659|Other|Self-Guided M.A.P. BP Improvement Program|Active Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group.
16407212|NCT03818659|Other|Full Support M.A.P. BP Improvement Program|"Active Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA Improvement Advisor, the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control."
16407213|NCT03816345|Biological|Nivolumab|Given IV
16407214|NCT03816163|Drug|zolbetuximab|Administered as an intravenous infusion.
16407215|NCT03816163|Drug|nab-paclitaxel|Administered as an intravenous infusion
16407216|NCT03816163|Drug|gemcitabine|Administered as an intravenous infusion
16407217|NCT03805932|Drug|Moxetumomab Pasudotox-tdfk|Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg iv over 30 min given on days 1, 3, 5 of each cycle.
16407218|NCT03805932|Biological|Rituximab|Rituximab will be administered at 375mg/m^2 iv, 50-400 mg/hr. On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
16407219|NCT03805204|Procedure|Open reduction and internal fixation (ORIF)|ORIF with a forearm plate
16407220|NCT03796689|Device|Smartphone-linked HBPM and associated app|Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publically available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
16407221|NCT03796689|Device|Standard HBPM|Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publically available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
16407225|NCT03789877|Other|Physical Activity|Participate in home-based walking program
16407226|NCT03789877|Other|Questionnaire Administration|Ancillary studies
16407227|NCT03789877|Procedure|Repetitive Transcranial Magnetic Stimulation|Undergo rTMS
16407228|NCT03789877|Procedure|Sham Intervention|Undergo sham rTMS
16407231|NCT03787628|Drug|Cannabidiol (CBD) 600 mg|CBD (300 mg) will be administered orally twice daily in the morning and again in the afternoon. The active ingredient in the Ananda investigational new drug, ATL5, is cannabidiol (CBD), extracted from hemp, at a 10% strength (softgel capsules with 100 mg/ml od CBD per capsule). The novel formulation is based on the principle that a water-free mixture of some concentrated inactive ingredients (excipients) self-assemble spontaneously into liquid nanodomains that contain the active component CBD. ATL5 Softgel Capsules will be manufactured by Baxco Pharmaceutical Inc., (California, USA) under cGMP conditions.
16407232|NCT03787628|Drug|CBD 1200 mg|CBD (600 mg) will be administered orally twice daily in the morning and again in the afternoon. The active ingredient in the Ananda investigational new drug, ATL5, is cannabidiol (CBD), extracted from hemp, at a 10% strength (softgel capsules with 100 mg/ml od CBD per capsule). ATL5 Softgel Capsules will be manufactured by Baxco Pharmaceutical Inc., (California, USA) under cGMP conditions.
16407233|NCT03787628|Drug|Placebo|The placebo softgel capsule formulation will have a composition with the same relative proportions as the CBD ATL5 Softgel Capsules. This formulation will be manufactured by Baxco Pharmaceutical Inc under cGMP conditions. Different amounts (numbers of softgel capsules) of placebo will be administered to match that of the active compound, daily in the morning and afternoon for each of 28 days.
16407234|NCT03786991|Other|No intervention|No intervention
16407235|NCT03781401|Device|Ambulatory blood pressure monitoring|
16407236|NCT03773471|Behavioral|Mobile Health App|ArthritisPower App
16407237|NCT03761537|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
16407238|NCT03761537|Other|Placebo|Placebo contains the same excipients in the same concentration only lacking tralokinumab.
16407239|NCT03760458|Drug|Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets|Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
16407240|NCT03760458|Drug|Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)|Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food
16407241|NCT03756792|Behavioral|Normal Education Material|Patients will receive standard educational material about Mohs micrographic surgery.
16407242|NCT03756792|Behavioral|Vignette|Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.
16407243|NCT03746301|Drug|Rivaroxaban(Xarelto,BAY 59-7939)|10mg, 15mg and 20 mg film-coated tablets
16407244|NCT03738904|Combination Product|ERAS|Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol
16407245|NCT03738904|Combination Product|Standard of care|Oxcodone PO Ketorolac IV only (intraop)
16407248|NCT03731260|Drug|Avapritinib|Avapritinib tablet
16407249|NCT03731260|Drug|Placebo|Placebo tablet
16407250|NCT03725202|Drug|Upadacitinib|It will be administered orally.
16407251|NCT03725202|Drug|Corticosteroid (CS)|It will be administered orally.
16407252|NCT03725202|Other|Placebo|It will be administered orally.
16407253|NCT03712982|Behavioral|Attention to Variability - Patient Only|In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.
16407254|NCT03712982|Behavioral|Attention to Variability - Partner Only|In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology in their partner that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.
16407255|NCT03712982|Behavioral|Attention to Variability - Patient & Partner|Same as patient and partner only conditions, just that in this condition both the patient and partner do their corresponding intervention rather than only one of them.
16407256|NCT03712982|Other|Infertility Stories - Reading|Reading Stories About Others' Infertility Experiences
16407257|NCT03710876|Biological|rAd-IFN|Adenovirus-Delivered Interferon Alpha-2b
16407258|NCT03710876|Drug|Celecoxib Oral Product|400 mg twice daily
16407259|NCT03710876|Drug|Gemcitabine|1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
16407260|NCT03707574|Procedure|Biospecimen Collection|Undergo collection of blood and tissue
16407264|NCT03688828|Drug|Saccharomyces boulardii|500mg bid
16407265|NCT03688828|Drug|Esomeprazole|20mg bid
16407266|NCT03688828|Drug|Amoxicillin|1.0g bid
16407267|NCT03688828|Drug|Clarithromycin|0.5g bid
16407268|NCT03688828|Drug|Bismuth potassium citrate|0.22g bid
16407269|NCT03688100|Behavioral|Behavioral Activation Therapy|The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.
16407270|NCT03688100|Drug|Medication Management|Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.
16407271|NCT03685344|Drug|Loncastuximab Tesirine and Durvalumab|intravenous infusion
16407272|NCT03670745|Behavioral|An electronic self-administered pre-visit planning tool.|An electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making during an office visit.
16407273|NCT03670745|Behavioral|Control group|No planning tool
16407274|NCT03662776|Behavioral|BASC-3 survey|A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
16407275|NCT03662776|Behavioral|PROMIS survey|A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
16407276|NCT03655236|Drug|K0706|low dose, orally, once-daily
16407277|NCT03655236|Drug|K0706|high dose, orally, once-daily
16407278|NCT03655236|Other|placebo|placebo, orally, once-daily
16407279|NCT03654547|Drug|TT-00420|"TT-00420 is an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor microenvironment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors.
~TT-00420 capsule will be administered once daily on a continuous schedule. A treatment cycle consists of 28 days.
~The proposed dosage form for early clinical research is powder filled hard gelatin capsule (PIC) with dosage strengths as of 1 mg, 5 mg and 20 mg."
16407280|NCT03646123|Drug|brentuximab vedotin|1.2 mg/kg by IV infusion
16407281|NCT03646123|Drug|doxorubicin|25 mg/m^2 by IV infusion
16407282|NCT03646123|Drug|vinblastine|6 mg/m^2 by IV infusion
16407283|NCT03646123|Drug|dacarbazine|375 mg/m^2 by IV infusion
16407284|NCT03646123|Drug|G-CSF|Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
16407285|NCT03646123|Drug|nivolumab|240 mg by IV infusion
16407286|NCT03644485|Drug|Tacrolimus immediate-release formulation|oral
16407287|NCT03644485|Drug|Tacrolimus prolonged-release formulation|oral
16407288|NCT03644485|Drug|Induction therapy|All participants will receive induction therapy. The dosage and administration of induction immunotherapy will be a single kind of drug determined by the investigator.
16407289|NCT03644485|Drug|Mycophenolic acid drugs|All participants will receive mycophenolic acid drugs in combination with corticosteroids. The dosage and administration of mycophenolic acid will be determined by the investigator.
16407290|NCT03644485|Drug|Corticosteroids|All participants will receive corticosteroids in combination with mycophenolic acid drugs. The dosage and administration of corticosteroids will be determined by the investigator.
16407291|NCT03643822|Drug|Dexamethasone 4mg|To guarantee rapid onset as well as effective postoperative analgesia, a 20 mL volume of local anesthetic has been selected for performing the ACB. The block solution will be a 20 ml volume for all groups, prepared by mixing 18 ml of ropivacaine 0.5% mixed with an additional 2 ml prepared according to the randomization.
16407292|NCT03643822|Drug|Dexmedetomidine|To guarantee rapid onset as well as effective postoperative analgesia, a 20 mL volume of local anesthetic has been selected for performing the ACB. The block solution will be a 20 ml volume for all groups, prepared by mixing 18 ml of ropivacaine 0.5% mixed with an additional 2 ml prepared according to the randomization.
16407293|NCT03643822|Other|Saline|Control/Placebo intervention
16407294|NCT03634150|Biological|Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.|Once weekly treatment, with IV doses of Nerofe (96mg\m2) and low dose (20 mg/m2) Doxorubicin 5 or 24 hours from one another) .
16407295|NCT03621735|Device|Burst-SCS/sham SCS|"The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.
~Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
~For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks."
16407423|NCT03206073|Drug|Durvalumab|1500 mg of durvalumab via intravenous (IV) infusion on Day 1 of each cycle until patients meet off treatment criteria
16407678|NCT02339571|Biological|Nivolumab|Given IV
16407296|NCT03621735|Device|Sham SCS/Burst-SCS|"Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
~The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.
~For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks."
16407297|NCT03616821|Drug|Brazikumab|Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
16407298|NCT03616821|Drug|Placebo|Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50.
16407299|NCT03604991|Drug|Carboplatin|Given IV
16407300|NCT03604991|Biological|Ipilimumab|Given IV
16407301|NCT03604991|Biological|Nivolumab|Given IV
16407302|NCT03604991|Drug|Paclitaxel|Given IV
16407303|NCT03604991|Radiation|Radiation Therapy|Undergo radiation therapy
16407306|NCT03596450|Drug|Semaglutide|Participants will be prescribed commercially available semaglutide and will be instructed to initiate treatment with semaglutide according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
16407307|NCT03596450|Drug|Standard of care|Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
16407308|NCT03593759|Drug|Prednisone or Prednisolone|Oral prednisone/prednisolone tablet
16407309|NCT03593759|Drug|Methotrexate|Oral, subcutaneous, or intramuscular methotrexate
16407310|NCT03581305|Drug|18F-FDOPA|High resolution positron emission tomography (PET) of the brain and radioligands targeted against the dopaminergic (18F-FDOPA) system.
16407311|NCT03581305|Drug|11C-DASB|High resolution positron emission tomography (PET) of the brain and radioligands targeted against the serotonergic (11C-DASB) system.
16407312|NCT03581084|Drug|N-acetylcysteine|Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart.
16407313|NCT03568656|Drug|CCS1477|Capsules, oral
16407314|NCT03568656|Drug|Abiraterone acetate|Abiraterone acetate 500mg tablets plus prednisone/prednisolone
16407315|NCT03568656|Drug|Enzalutamide|Enzalutamide 40mg capsules/tablets
16407316|NCT03567590|Procedure|Pulsed Radiofrequency treatment|The pulse treatment generator (PMF-21-100-5, Baylis Medical Inc., Montreal, Canada) with a length of 10 cm, 21-gauge, and an active tip length of 5 mm is inserted vertically into the puncture point. The pulse treatment generator is set to the pulsed radiofrequency automatic mode, with a temperature of 42 °C, pulse frequency of 2 Hz, pulse width of 20 ms, and treatment duration of 360s.
16407317|NCT03567590|Procedure|Nerve Block treatment|A mixture of 40 mg Triamcinolone + 2 ml of 1% Bupivacaine + 2 ml of 2% mepivacaine + 1:100000 epinephrine is injected for nerve block treatment using a puncture needle.
16407318|NCT03564821|Drug|Ivosidenib|Ivosidenib is an inhibitor of the protein IDH1
16407321|NCT03552393|Drug|Mircera|The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.
16407322|NCT03549507|Drug|Sulfur hexafluoride lipid-type A microspheres|Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed to evaluate for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.
16407323|NCT03540732|Other|Indirect Calorimetry directed feeding.|Indirect calorimetry directed feeding (use of indirect calorimetry to calculate daily caloric requirement)
16407324|NCT03540732|Procedure|Cycle Ergometry|Up to 60 minutes of cycle ergometry daily in addition to standard physiotherapy sessions.
16407327|NCT03528642|Other|Questionnaire Administration|Ancillary studies
16407328|NCT03528642|Radiation|Radiation Therapy|Undergo RT
16407329|NCT03528642|Drug|Telaglenastat Hydrochloride|Given PO
16407330|NCT03528642|Drug|Temozolomide|Given PO
16407333|NCT03518359|Behavioral|Enhanced Stress Resilience Training (ESRT)|ESRT involves six weekly 90-minute group classes and one 2 - 4 hour retreat. Classes focus on developing mindfulness skills (i.e. sustained attention, open monitoring, emotional regulation, meta-cognition) in the context of skills and concepts for managing stress, particularly in practicing medicine. Homework consists of 20 minutes per day of mindfulness exercises following guided meditation CDs or videos of movement-based practice, and practice will be reported periodically by text. A 3-hour outdoor retreat occurs at week six. The central exercises of ESRT are the body scan, sitting meditation, chi gong and yoga. For both arms, the weekly teaching sessions occur on a workday morning during protected time at Parnassus, Mission Bay or Zuckerberg San Francisco General Hospital campus.
16407424|NCT03206073|Drug|Tremelimumab|300 mg of tremelimumab via intravenous (IV) infusion on Day 1 of cycle 1
16407425|NCT03206073|Biological|Pexa-Vec|3 x 10E^8 plaque-forming unit (pfu) (Dose Level (DL) 1) via intravenous (IV) infusion for 4 doses: Day 12, Day 2, Day 16 of Cycle 1 and Day 2 of Cycle 2.
16407426|NCT03206073|Biological|Pexa-Vec|1 x 10E^9 pfu (DL 2) via intravenous (IV) infusion for 4 doses: Day 12, Day 2, Day 16 of Cycle 1 and Day 2 of Cycle 2.
16407334|NCT03518359|Behavioral|Active Control|Control group participants will meet for 6 weeks, 90 minutes each week, for classes focuses on stress management through rest and exercise, with equivalent protected time and small group bonding but without the use of contemplative practices. Topics will include the history of surgery, patient perspective, the physician personality, technical mastery, fallibility and limits, balancing compassion and detachment and knowing when not to operate. For daily practice, control participants will be asked to devote 20 min per day to stress management through rest and exercise again reported daily by text.
16407335|NCT03516877|Behavioral|Enhanced Stress Resilience Training for Faculty Physicians|Enhanced Stress Resilience Training (ESRT) is derived from Mindfulness-Based Stress Reduction with modifications to language, activities and contextualization to tailor the training to physicians involved in the operating room environment. ESRT consists of 5 weekly 1-hour group classes and 2-4 hour retreat. Classes focus on developing sustained attention and open monitoring in addition to training focused on stress and coping. Increasing duration (3-20 minutes per day) of guided mindfulness exercises are assigned each week. A 2-4 hour intensive retreat occurs at week 4 or 5. The central exercises of the training are the body scan, sitting meditation, qi gong and yoga. The weekly teaching sessions will be offered at various days and times each week in order to accommodate complicated physicians schedules that vary at each site. Participants can attend whichever session is most convenient. Daily practice will occur independently, with the duration reported weekly through text or email.
16407336|NCT03513614|Procedure|Tailored axillary surgery - both Arms|Axillary lymph node dissection - Arm A
16407337|NCT03513614|Radiation|Radiotherapy - Arm A|Regional nodal irradiation excluding the dissected axilla - Arm A
16407338|NCT03513614|Radiation|Radiotherapy - Arm B|Regional nodal irradiation including the full axilla - Arm B
16407341|NCT03485209|Drug|tisotumab vedotin|Given into the vein (IV; intravenously)
16407342|NCT03465722|Drug|avapritinib|Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
16407343|NCT03465722|Drug|regorafenib|Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
16407344|NCT03458728|Drug|BAY806946|Copanlisib will be dosed on Day 1, Day 8, and Day 15 of every 28-day cycle. Phase 1: 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Phase 2: RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
16407345|NCT03446053|Biological|N-Rephasin® SAL200|continuous intravenous infusion over 60 minutes
16407346|NCT03446053|Other|INT200-Placebo|Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes
16407347|NCT03422822|Drug|Abrocitinib 100 mg|In the initial treatment period, Abrocitinib 100 mg, administered as two tablets to be taken orally once daily.
16407348|NCT03422822|Drug|Abrocitinib 200 mg|In the initial treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
16407349|NCT03422822|Drug|Placebo|For subjects whose dose was changed from 100 mg Abrocitinib to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
16407350|NCT03422822|Drug|Abrocitinib 100 mg|For subjects whose dose was changed from 200 mg Abrocitinib to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
16407351|NCT03422822|Drug|Abrocitinib 100 mg|In the secondary treatment period, Abrocitinib 100 mg, administered as one tablet to be taken orally once daily.
16407352|NCT03422822|Drug|Abrocitinib 200 mg|In the secondary treatment period, Abrocitinib 200 mg, administered as two tablets to be taken orally once daily.
16407353|NCT03391479|Drug|Avelumab|Avelumab is a fully human monoclonal antibody (mAb) of the immunoglobulin (Ig) G1 isotype. Avelumab selectively binds to programmed death-ligand 1 (PD-L1) and competitively blocks its interaction with programmed death protein 1 (PD-1).
16407354|NCT03391479|Other|Best Supportive Care|As required.
16407355|NCT03389347|Procedure|Biospecimen Collection|Undergo collection of bone marrow aspirate and blood
16407356|NCT03389347|Device|High Throughput Screening|Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay
16407357|NCT03389347|Other|Laboratory Biomarker Analysis|Correlative studies
16407358|NCT03371030|Procedure|Pronatus quadratus reparation|Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.
16407359|NCT03369444|Biological|FLT180a|FLT180a is a replication-incompetent adeno- associated viral vector. The vector is composed of a DNA vector genome encapsidated in an adeno-associated virus derived protein capsid. The expression cassette contains DNA encoding Factor IX.
16407360|NCT03367741|Drug|Cabozantinib S-malate|Given PO
16407361|NCT03367741|Biological|Nivolumab|Given IV
16407362|NCT03364283|Procedure|Surgical position|
16407363|NCT03350815|Drug|150 mg open-label secukinumab|All patients in Treatment Period 1 will receive 150 mg open-label secukinumab.
16407364|NCT03350815|Drug|150 mg double-blinded secukinumab|Treatment Period 2
16407365|NCT03350815|Drug|300 mg double-blinded secukinumab|Treatment Period 2
16407366|NCT03344991|Other|Cardboard Cot Care|When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
16407427|NCT03206047|Drug|Atezolizumab|Given IV
16407428|NCT03206047|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given SC
16407367|NCT03344991|Other|Open Crib|When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
16407368|NCT03344978|Other|Cardboard Cot Care|Infant maintained in reflective film-lined cot for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. Infant may be moved to incubator or radiant warmer. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible.
16407369|NCT03344978|Other|Incubator Care|Infant maintained in standard incubator for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible.
16407370|NCT03344666|Behavioral|Step 1 Treatment BI+HC|Participants in the Brief intervention + Health Coach (BI+HC) will receive a BI in the ED, followed by weekly sessions with the Health Coach for 4 weeks, which will occur by phone or in person. During sessions, the HC will review the prior week's progress, and discuss goals and plans for the following week.
16407371|NCT03344666|Behavioral|Step 1 Treatment BI+TM|Participants in the Brief intervention + Text messages (BI+TM) will receive a BI in the ED, followed by daily TMs for 4 weeks. TM's are tailored based on weekly surveys and focus on motives for alcohol and violence and strategies to reduce involvement.
16407372|NCT03344666|Behavioral|Step 2 Treatment Responders|"Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC.
~Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM.
~Participants in the BI+HC or BI+TM assigned to stepped down control will receive a brochure containing community resources."
16407373|NCT03344666|Behavioral|Step 2 Treatment Non-Responders|"Participants in the BI+HC assigned to be stepped up will receive HC+, which will consist of weekly sessions as well as on daily TMs from the HC.
~Participants in the BI+HC assigned to stay the course (e.g., continue to receive the HC) will have 4 more weekly sessions with the HC.
~Participants in the BI+TM assigned to be stepped up will receive the HC, which consists of 4 weekly sessions with the HC.
~Participants in the BI+TM assigned to stay the course (e.g., continue to receive the TM) will receive 4 more weeks of TM."
16407374|NCT03331380|Device|MRI scan|For objective 1 (protocol optimization), healthy volunteers undergo imaging using an investigational low SAR CMR scanner for up to two hours, some without- and some with- administration of intravenous gadolinium based contrast agents (GBCAs).
16407375|NCT03331380|Device|MRI scans|For objective 2 (comparative scanning of normals), healthy volunteers undergo two CMR examinations on two different MRI scanners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with- administration of intravenous GBCA.
16407376|NCT03331380|Device|MRI scans|For objective 3 (comparative scanning of patients), subjects with known stable cardiovascular disease undergo two CMR examina-tions on two different MRI scanners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with- admin-istration of intravenous GBCA.
16407377|NCT03331380|Device|MRI scans|For objective 4 (comparative scanning of patients), subjects with known or suspected disease, including neurological, musculoskeletal disease, abdominal or lung disease, will undergo two MR examinations on two different MRI scanners (investigational low SAR CMR and conventional MR).
16407378|NCT03329378|Drug|Docetaxel|Docetaxel 75mg/m2 IV, day 1
16407379|NCT03329378|Drug|Carboplatin|Carboplatin AUC 6 IV, day 1
16407380|NCT03329378|Drug|Trastuzumab|Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
16407381|NCT03329378|Drug|Pertuzumab|Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
16407382|NCT03329378|Drug|Pegfilgrastim|Pegfilgrastim 6mg SC, day 2 Cycled as per arm
16407383|NCT03329378|Drug|Trastuzumab|Trastuzumab 6mg/kg every 21 days to complete 1 year
16407384|NCT03329378|Drug|Paclitaxel|Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
16407385|NCT03329378|Drug|Doxorubicin|Doxorubicin 60 mg/m2 IV day 1
16407386|NCT03329378|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 IV day 1
16407387|NCT03329378|Drug|Paclitaxel|80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
16407388|NCT03323801|Drug|13-cis retinoic acid|Accutane is used for the treatment of severe acne
16407389|NCT03318666|Behavioral|Supporting Our Valued Adolescents (SOVA)|"The SOVA intervention includes:
~a welcome email to the websites (adolescents also get a SOVA intro video and mobile app)
~adolescents will have access to the website specifically for adolescents: sova.pitt.edu
~parents will have access to the website specifically for parents: wisesova.pitt.edu
~These anonymous websites aim to: (1) challenge negative health beliefs and increase depression/anxiety knowledge through daily blog posts enhanced with peer commentary; (2) promote social support through online peer interactions; and (3) encourage parent-adolescent mental health communication through same day blog posts with questions for discussion. Parents and adolescents cannot log on to each other's sites. The sites are moderated by our research team.
~The SOVA websites include articles composed by SOVA Peer Ambassadors who are adolescents and young adults who have experienced symptoms of depression or anxiety and contribute monthly articles and regular comments."
16407429|NCT03206047|Drug|Guadecitabine|Given SC
16407430|NCT03206047|Other|Laboratory Biomarker Analysis|Correlative studies
16407431|NCT03206047|Drug|Poly ICLC|Given SC
16407432|NCT03190967|Drug|T-DM1|T-DM1 3.6 mg/kg IV every 21 days
16407433|NCT03190967|Drug|TMZ|Phase I: TMZ 30, 40 or 50 mg/m2 daily Phase II: TMZ at RP2D estimated in Phase I
16407679|NCT02339571|Biological|Sargramostim|Given SC
16407390|NCT03318666|Other|Enhanced Usual Care|A social worker at the Center for Adolescent and Young Adult Health (CAYAH) clinic helps to facilitate referrals from the adolescent healthcare provider (AHCP) and contacts patients who do not schedule for within-CAYAH appointments.The study will send an extra email to the parent and adolescent that contains the content of the depart summary as well as a list of psychoeducational materials, how to contact the AHCP, CAYAH social worker, and crisis resources and the AHCP's treatment recommendation which are obtained from the electronic health record. Also, each individual will receive a phone call from a research assistant who will communicate the information in the email and offer to inform the social worker or AHCP of questions the patient or parent may have.
16407391|NCT03318380|Procedure|Dynamic Contrast-Enhanced Ultrasound Imaging|Undergo CEUS
16407392|NCT03315910|Behavioral|Motivational Interviewing (MI)|two counseling sessions
16407393|NCT03315910|Drug|Nicotine Replacement Therapy (NRT)|receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
16407394|NCT03315910|Drug|Nicotine Lozenge|6 packs of NRT 2mg lozenge
16407395|NCT03315910|Behavioral|Message Framing|health communication literature and quitting messages
16407396|NCT03315910|Other|saliva sample|saliva samples from those reporting abstinence and analyze samples
16407397|NCT03289039|Drug|Neratinib|Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
16407398|NCT03289039|Drug|Fulvestrant|Fulvestrant, works in treating breast cancer that has spread to other parts of the body
16407399|NCT03284827|Drug|NOAC|edoxaban (60 mg once daily [OD]) for at least 6 months
16407400|NCT03284827|Drug|DAPT|clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
16407401|NCT03273855|Other|Fecal microbiota transplantation|The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.
16407402|NCT03273855|Other|Placebo: fecal microbiota transplantation|The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.
16407403|NCT03270059|Drug|Ferumoxytol|Given IV
16407404|NCT03270059|Drug|Gadolinium|Given IV
16407405|NCT03270059|Procedure|Magnetic Resonance Imaging|Undergo MRI
16407406|NCT03269032|Other|American Diet|"According to National Health and Nutritional Examination Survey (NHANES) data, the nutritional composition of the baseline typical American diet is 50%Carbohydrates, 15% Protein, 35% Fat, >11% Saturated Fatty Acids, <12% Monounsaturated Fatty Acids, and >8% Polyunsaturated Fatty Acids.
~Participants will receive 3 meals and 1 snack for each day during the study period."
16407407|NCT03269032|Other|Mediterranean-style Diet|"The nutritional composition of the baseline typical Mediterranean-style diet is 46% Carbohydrates/Alcohol (red wine will be included in the Mediterranean diet only), 17% Protein, 32% Fat, <7% Saturated Fatty Acids, >18% Monounsaturated Fatty Acids and <5% Polyunsaturated Fatty Acids.
~Participants will receive 3 meals and 1 snack for each day during the study period."
16407408|NCT03268083|Biological|EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)|Two vaccinations at 28 days apart
16407409|NCT03268083|Biological|EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)|Two vaccinations at 28 days apart
16407410|NCT03268083|Biological|EV71 vaccine ([1 μg total protein ] per dose)|Two vaccinations at 28 days apart
16407411|NCT03267277|Drug|Sodium Thiosulfate|Sodium thiosulfate is a calcium chelator
16407414|NCT03246568|Procedure|Renal Nerve Denervation|Bilateral renal denervation using a multi-polar radiofrequency ablation catheter (Symplicity™ Spyral Cather, Medtronic) in the right and left main, branch, and accessory renal arteries in vessels ranging in diameter between 3 and 8 mm.
16407415|NCT03246568|Procedure|Pulmonary vein isolation|PVI by cryo-balloon ablation without linear ablation
16407416|NCT03231735|Device|Mid frequency ventilation|Mechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
16407417|NCT03231735|Device|Standard frequency ventilation|Mechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
16407418|NCT03227757|Device|Tricuspid Valve Repair System|Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
16407419|NCT03216109|Behavioral|Weekly telephone symptom assessment|Each patient who is enrolled in the intervention will receive a weekly phone call from the Research Assistant for a total of 9 months to assess symptoms using the Edmonton Symptom Assessment Scale. Results of the symptom assessments will be provided to the clinic staff (RN and MD) for review each week. Care plans will be generated using an electronic management platform
16407434|NCT03174002|Drug|Oxygen|Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
16407435|NCT03174002|Drug|Oxygen|Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
16407436|NCT03170817|Diagnostic Test|Cardiac Perfusion Rest/Stress Digital PET/CT|"Patients with coronary artery disease undergo a N-13 ammonia rest/stress PET/CT scan.
~These patients are given:
~One 5-10 mCI N13-ammonia (13N-NH3) intravenously and undergo a rest digital PET/CT scan of ~20 minute duration.
~A dose of 0.4 mg regadenoson (Lexiscan) intravenously over 10 seconds to increase blood flow to the heart
~One 5-10 mCi N13-ammonia (13N-NH3) intravenously and undergo a stress digital PET/CT scan of ~20 minute duration
~Total patient time will take approximately up to 120 minutes."
16407437|NCT03170817|Drug|N-13 ammonia|5-10 mCi intravenous injection of N-13 ammonia radiopharmaceutical at rest and at stress
16407438|NCT03170817|Drug|Regadenoson|0.4 mg/5mL intravenous injection to induce pharmacologic stress (Astellas Pharma US, Inc.)
16407439|NCT03168347|Behavioral|Anecdotal Evidence|Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.
16407440|NCT03168347|Behavioral|Research Study Evidence|Communicate basic information on the therapeutic effect of a drug using only research study evidence.
16407441|NCT03168347|Behavioral|Anecdotal + Research Study Evidence|Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.
16407442|NCT03168347|Behavioral|No Evidence|Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.
16407443|NCT03158688|Drug|Dexamethasone|Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants > 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib.
16407444|NCT03158688|Drug|Daratumumab|Daratumumab was supplied as a concentrated solution for infusion in single-use vials.
16407445|NCT03158688|Drug|Carfilzomib|"Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes.
~Dose could be modified based on a >20% change in body weight or toxicity."
16407463|NCT03151798|Behavioral|Phase II: Lifestyle treatment|Subjects will undergo energy restriction and exercise training over a 9 month period.
16407464|NCT03151798|Behavioral|Phase II: Control treatment|Subjects will receive dietary advice and receive information on a stretching program.
16407465|NCT03151798|Other|Phase I: Observational studies|The liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat
16407466|NCT03150056|Drug|GSK525762|GSK525762 will be administered.
16407467|NCT03150056|Drug|Abiraterone|Abiraterone will be administered.
16407468|NCT03150056|Drug|Enzalutamide|Enzalutamide will be administered.
16407469|NCT03150056|Drug|Prednisone|Prednisone will be administered as a concomitant medication in combination with abiraterone
16407470|NCT03148275|Other|Questionnaire Administration|Ancillary studies
16407471|NCT03148275|Drug|Trametinib|Given PO
16407472|NCT03141736|Other|KMC & WHO protocol (0-1 hour)|WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling
16407473|NCT03141736|Other|KMC, WHO protocol & bag (0-1 hour)|In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost [3 cents per bag]
16407474|NCT03141736|Other|KMC & WHO protocol (1-24 hours)|WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling
16407475|NCT03141736|Other|KMC, WHO protocol & bag (1-24 hours)|In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost [3 cents per bag]
16407476|NCT03140696|Dietary Supplement|Egg Alone|A chicken egg will be offered for 2 days
16407477|NCT03140696|Dietary Supplement|Egg and ready to use supplementary food (RUSF)|A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days
16407478|NCT03140696|Dietary Supplement|Egg and breast milk|A chicken egg and breast milk will be offered for 2 days
16407479|NCT03131466|Device|High-voltage pulsed radiofrequency|The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.
16407575|NCT02817633|Drug|Cisplatin|
16407576|NCT02817633|Drug|Carboplatin|
16407577|NCT02805517|Device|Percuvance™ Percutaneous Surgical System|Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars.
16407480|NCT03131466|Drug|Nerve block|The radiofrequency generator will be set at the sensory stimulating mode, and the lowest frequency of 0.2 V will be used for 360s-sham PRF treatment, after which 1.4 mL of a mixture of 2 mg of dexamethasone sodium phosphate and 1 mL of 1% plain lidocaine will be slowly injected through the radiofrequency treatment cannula needle. Before the needle being removed, 0.5 mL of normal saline will be injected.
16407481|NCT03117309|Drug|Nivolumab 240 mg|PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment
16407482|NCT03117309|Drug|Ipilimumab 1mg/kg|Ipilimumab 1 mg/kg every 3 weeks x 4
16407483|NCT03117309|Drug|Nivolumab 3mg/kg|In combination with Ipilimumab
16407484|NCT03117309|Drug|Nivolumab 360mg|Continue Nivolumab 360 mg IV every 3 weeks
16407485|NCT03115788|Other|Heat induced pain|For the heat induced thermal pain, the research nurse will train the subject to estimate pain quantitatively using a 2 cm 2 Peltier controlled thermode (TSA®) applied to the skin of the arm. Typically, the subject is exposed to temperatures between 41° and 49° C using a random staircase method. After the volunteer learns to qualitatively estimate the thermal pain, pain will be established by heating the the leg with a 4 cm2 Peltier controlled thermode (TSA®) for 90 seconds with the probe clamped at a thermal intensity of 47°C.
16407486|NCT03115788|Other|Cold Induced Pain|Cold pain will be induced by placing a foot in a container of circulating water maintained at 10°C for 90 seconds (n=20). Half (n=20) of the subjects will have the foot placed in body temperature water of 38°C.
16407487|NCT03115788|Device|iPad|
16407488|NCT03115450|Device|Ultrasound|Type of imaging technology to look at organs and structures inside the body
16407489|NCT03115450|Device|Pupilometer|A device that measures pupil size and how it changes.
16407490|NCT03096808|Radiation|Adaptive Radiotherapy|ART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss.
16407491|NCT03094637|Drug|Azacitidine|Given IV
16407492|NCT03094637|Biological|Pembrolizumab|Given IV
16407493|NCT03090022|Procedure|Strattice|Intra-abdominally Fixation
16407494|NCT03090022|Procedure|Single running suture of abdominal fascia|Intra-abdominal suture
16407495|NCT03060174|Other|monitoring and non-medical prophylaxis of delirium|
16407496|NCT03060057|Device|U2 Knee™ System|The United U2 Knee™ System consists of several components and for this clinical evaluation it includes the (1) Femoral Component, (2) Tibial Insert, 3) Tibial Baseplate, and the 4) Patella.
16407497|NCT03038672|Biological|Nivolumab|Given IV
16407498|NCT03038672|Drug|Varlilumab|Given IV
16407499|NCT03032172|Drug|Risdiplam|Risdiplam will be administered orally once daily.
16407500|NCT03030378|Biological|Edodekin alfa|Given SC
16407501|NCT03030378|Biological|Pembrolizumab|Given IV
16407503|NCT03026764|Procedure|Outpatient|Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty
16407504|NCT03026764|Procedure|Inpatient|Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty
16407505|NCT03025425|Device|Trilogy 100 ® (Philips Respironics)|Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).
16407506|NCT03019939|Drug|Isavuconazole|Given PO or IV
16407507|NCT02998879|Drug|Velmanase Alfa (e.g. Lamazym)|iv infusion treatment
16407508|NCT02979873|Drug|Sirolimus|Sirolimus will be started on day 1 for subjects in the Sirolimus arm. A baseline CBC will be obtained within one week of randomization, or on Day 0. Thereafter, CBC will be monitored on a weekly basis for subjects in both arms. In the event of relapse (see definition of outcomes Section 6.7), the patient shall return to the NIH CRC for evaluation to include bone marrow biopsy and aspirate to exclude clonal evolution to MDS. Assessment will include flow cytometry phenotyping of peripheral blood mononuclear cells for regulatory T-cells (Tregs, e.g. CD4+ CD25high FOXP3+) and regulatory dendritic cells (DCregs) and proteomics assay (research labs).
16407509|NCT02979860|Behavioral|Sleep duration 90 min|Sleep duration: time in bed increased by 90 minutes
16407510|NCT02979860|Behavioral|Sleep duration 45 min|Sleep duration: time in bed increased by 45 minutes
16407511|NCT02979860|Behavioral|Sleep timing|Sleep timing: bed time kept consistent
16407512|NCT02973516|Drug|P03277 at 0.1 mmol/kg|P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
16407513|NCT02973516|Drug|P03277 at 0.05 mmol/kg|P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
16407514|NCT02960659|Drug|Metformin and Liraglutide|Randomized controlled trial of metformin + liraglutide vs. metformin alone over 3 months in youth with type 2 diabetes.
16407515|NCT02960659|Drug|Metformin|Paired study of metformin over 3 months in youth with type 2 diabetes compared to controls (youth with prediabetes or type 2 diabetes not treated with metformin).
16407516|NCT02951364|Drug|LDV/SOF|90/400 mg tablet administered orally once daily
16407517|NCT02926651|Drug|Conventional Oral TXA (Tranexamic Acid)|Three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1.
16407518|NCT02926651|Drug|Multi-Dose Oral TXA (Tranexamic Acid)|Three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1.
16407519|NCT02925338|Other|QOL questionaire|Health assessment questionnaire disability index for rheumatoide polyarthritis questionnair
16407675|NCT02356159|Drug|Palifermin|Escalating doses of palifermin given during transplant phase
16407526|NCT02905370|Behavioral|Progressive Multi-Component (PMC)|"Participants in the Progressive Multi-component intervention group will receive 1) high intensity physical therapy, 2) protein supplement, and 3) emphasis on functionally enhanced transitions of care following discharge from post-acute setting. High intensity physical therapy will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Functionally enhanced transitions of care protocol includes a personal health record with 5 domains that are addressed in an interdisciplinary manner with the patient. Participants will receive 12 intervention visits over 60 days. Participants will also receive a home exercise program."
16407527|NCT02905370|Behavioral|Usual Care (UC)|"Participants in the Usual Care group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 60 days. Participants will also receive a standardized home exercise program and standard nutritional education."
16407528|NCT02896335|Drug|Palbociclib|
16407529|NCT02885714|Procedure|Placebo surgery and supervised specific exercises|The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated. Nothing is to be removed or excised and the use of any vapour or shaver device is not allowed. The presence of a full-thickness rotator cuff tear is verified. Altogether 3 to 5 small stab wounds are made in typical locations resembling locations of typical rotator cuff repair. The time spent in the operating theatre with patients in placebo group should resemble the time spent with patients in the active treatment group and hence give an impression of a rotator cuff repair.
16407530|NCT02885714|Procedure|Rotator cuff repair and supervised specific exercises|The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated and the presence of a full-thickness rotator cuff tear is verified. The cuff tear is repaired to its anatomic location using suture anchors according to surgeon preference. . A biceps tenotomy or tenodesis may be performed according to surgeon preference if the biceps tendon is noted to be frayed, unstable or inflamed. An additional acromioplasty may be performed according to surgeon preference.
16407531|NCT02856490|Device|vSculpt|A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
16407532|NCT02856490|Device|InTone|A genital device using electric muscle stimulation to treat incontinence.
16407533|NCT02852213|Drug|AAV2-hAADC|"Subjects will be enrolled sequentially into 2 dose groups, Group 1 followed by Group 2. Initially, up to 3 subjects initially will be enrolled in Group 1 and treated with a single dose of AAV2 hAADC (1.3x10 11 vg, delivered as an infusate volume of up to 160 μL of vector at concentration of 8.3x10 11 vg/mL) on Day 0. Enrollment in Group 2 may commence after the last subject in Group 1 is treated and followed through Month 3 post-surgery, with the approval of the data safety monitoring board (DSMB).
~The final safety and clinical outcome assessments will be performed 1 year post-surgery. A follow-up analysis will be performed for 2 years post-surgery. Thereafter, subjects will be enrolled in a long-term follow-up study to assess safety and clinical status updates."
16407534|NCT02845323|Drug|Nivolumab in combination with Urelumab|Two cycles of Nivolumab Two cycles of Urelumab
16407535|NCT02845323|Drug|Nivolumab monotherapy|Two cycles of Nivolumab alone
16407536|NCT02843074|Drug|elotuzumab|Given intravenously (IV)
16407537|NCT02843074|Drug|Lenalidomide|Given by IV
16407538|NCT02843074|Drug|Dexamethasone|Given orally (PO) or by IV
16407539|NCT02843074|Procedure|autologous stem cell transplantation|
16407543|NCT02829918|Drug|Nivolumab|Participants will receive nivolumab at a dose of 240 mg intravenously (IV) every 2 weeks (Q 2W) for 16 weeks (16W) and then 480 every 4 weeks (Q4W) from 17 weeks to end of study.
16407544|NCT02829099|Drug|JNJ-64457107|JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle.
16407545|NCT02828358|Drug|Azacitidine|Given IV
16407546|NCT02828358|Drug|Cyclophosphamide|Given IV
16407547|NCT02828358|Drug|Cytarabine|Given IV, SC, IT
16407548|NCT02828358|Drug|Daunorubicin|Given IV
16407549|NCT02828358|Drug|Daunorubicin Hydrochloride|Given IV
16407550|NCT02828358|Drug|Dexamethasone|Given PO, NG, IV
16407551|NCT02828358|Drug|Hydrocortisone Sodium Succinate|Given IT
16407552|NCT02828358|Other|Laboratory Biomarker Analysis|Correlative studies
16407553|NCT02828358|Drug|Leucovorin|Given PO, IV
16407554|NCT02828358|Drug|Leucovorin Calcium|Given PO, IV
16407555|NCT02828358|Drug|Mercaptopurine|Given PO, NG
16407556|NCT02828358|Drug|Methotrexate|Given IT, IV, PO
16407557|NCT02828358|Drug|Pegaspargase|Given IV
16407558|NCT02828358|Other|Pharmacological Study|Correlative studies
16407559|NCT02828358|Drug|Prednisolone|Given PO, NG
16407560|NCT02828358|Drug|Thioguanine|Given PO, NG
16407561|NCT02828358|Drug|Vincristine|Given IV
16407562|NCT02828358|Drug|Vincristine Sulfate|Given IV
16407569|NCT02817633|Drug|TSR-022|TSR-022 will be administered.
16407570|NCT02817633|Drug|Nivolumab|Nivolumab will be administered.
16407571|NCT02817633|Drug|TSR-042|TSR-042 will be administered.
16407572|NCT02817633|Drug|TSR-033|TSR-033 will be administered.
16407573|NCT02817633|Drug|Docetaxel|Docetaxel will be administered.
16407574|NCT02817633|Drug|Pemetrexed|
16407578|NCT02805504|Drug|Exparel|This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
16407579|NCT02805504|Drug|Marcaine|This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
16407580|NCT02804087|Device|MobiusHD|The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
16407581|NCT02804087|Other|Sham Implantation|Sham Implantation
16407582|NCT02790723|Drug|sc-rAAV2.5IL-1Ra|Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
16407583|NCT02784210|Drug|Methylprednisolone|3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day
16407584|NCT02784210|Drug|Prednisone|3 days of corticosteroids (oral prednisone at 1250 mg/day
16407585|NCT02769962|Drug|EP0057|"EP0057 IV Q 2weeks Day 1 and Day 15, administered in 28 day cycles, until disease progression or development of intolerable side effects
~Plus olaparib (PO days 3-13* and days 17-26*) administered in 28 day cycles, until disease progression or development of intolerable side effects. P1: Dose Escalation P2: RP2D
~(* On days 13 and 26, only one dose of olaparib will be administered in the morning)"
16407586|NCT02769962|Drug|olaparib|olaparib (PO days 3-13* and days 17-26* administered in 28 day cycles, until disease progression or development of intolerable side effects Plus EP0057 (IV Q 2weeks, Day 1 and Day 15) administered in 28 day cycles, until disease progression or development of intolerable side effects P1: Dose Escalation P2: RP2D (* On days 13 and 26, only one dose of olaparib will be administered in the morning)
16407587|NCT02761499|Device|U-Motion II+ Acetabular System|U-Motion II+ Acetabular System (1) U-Motion II+ acetabular cup, (2) U-Motion II+ acetabular liner, (3) Cobalt-Chrome or BIOLOX delta ceramic femoral heads, and the 4) UTF Reduced Stem
16407588|NCT02749903|Drug|enzalutamide|oral
16407589|NCT02720445|Drug|Nicotine Transdermal Patch|21mg Nicotine transdermal patches worn during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 6 weeks of treatment, remain at 21mg for 22.5 months, and then taper down in the final month of treatment.
16407590|NCT02720445|Drug|Placebo Patch|Matching placebo patches worn during waking hours.
16407591|NCT02715609|Drug|Disulfiram|
16407592|NCT02715609|Drug|Copper Gluconate|
16407593|NCT02715609|Procedure|Surgery|
16407594|NCT02715609|Radiation|Radiation|
16407595|NCT02715609|Drug|Temozolomide|
16407596|NCT02704858|Drug|Perillyl alcohol|Intranasal administration
16407597|NCT02697487|Other|No treatment|This is an observational study with no intervention.
16407598|NCT02687451|Drug|Oxymorphone HCl|Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC).
16407599|NCT02687451|Drug|Placebo|Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.
16407601|NCT02661672|Device|Apollo Device|The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.
16407602|NCT02661672|Device|Artemis Device|The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
16407603|NCT02657928|Other|Laboratory Biomarker Analysis|Correlative studies
16407604|NCT02657928|Drug|Letrozole|Given PO
16407605|NCT02657928|Drug|Ribociclib|Given PO
16407606|NCT02654015|Device|Apollo MIES|Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
16407607|NCT02654015|Other|Medical Management|Subjects will receive best medical management for intracranial hemorrhage
16407610|NCT02629822|Drug|Doravirine/lamivudine/tenofovir disoproxil fumarate|FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.
16407611|NCT02618980|Other|endoscopic hemostasis|At endoscopy, stigmata of hemorrhage (SRH) will be treated by dual endoscopic local therapy (combining at least two of the following treatments: epinephrine injection, coaptive thermocoagulation, hemoclip therapy, argon plasma coagulation, bipolar coagulation).
16407612|NCT02608684|Drug|Pembrolizumab|Pembrolizumab IV solution
16407613|NCT02608684|Drug|Gemcitabine|Gemcitabine IV solution
16407614|NCT02608684|Drug|Cisplatin|Cisplatin IV solution
16407615|NCT02605148|Dietary Supplement|Gluten free diet|Gluten free diet during 18 months.
16407616|NCT02605148|Dietary Supplement|Omega 3 fatty acid|Omega 3 fatty acid
16407617|NCT02605148|Dietary Supplement|Vitamin D|Vitamin D 800 U/day
16407618|NCT02605148|Dietary Supplement|Probiotics|Probiotics
16407619|NCT02595944|Biological|Nivolumab|Given IV
16407620|NCT02554773|Drug|Fitusiran (SAR439774)|Pharmaceutical form: solution for injection Route of administration : subcutaneous (sc)
16407621|NCT02546921|Drug|MOv18 IgE|The allocated dose of MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for six weeks.
16407622|NCT02535702|Other|In vivo MRS|1H MR spectroscopy to assess brain metabolites.
16407623|NCT02535702|Other|fMRI|Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.
16407624|NCT02535702|Other|sMRI|High spatial resolution MRI and diffusion tensor imaging (DTI) to assess brain morphology and structural connectivity.
16407625|NCT02535702|Other|EEG/EOG|Electroencephalography or electrooculography (EEG/ EOG) sessions to record electrical activity of the brain or measure corneo-retinal standing potentials.
16407626|NCT02535702|Other|Stimulation tasks|To be used in the context of fMRI to study blood-oxygenation-level dependent responses in the brain to sensory stimulation.
16407627|NCT02535702|Other|NSPRD|To be used in conjunction with pupillometry in the context of fMRI to study blood-oxygenation-level-dependent responses to selective neurostimulation of pain fibers.
16407676|NCT02351284|Other|Measurement|Measurement of vitamin D, PTH, and BMD changes in HIV-infected patients
16407629|NCT02511028|Drug|Ferumoxytol|510mg (17mL) IV
16407630|NCT02505750|Radiation|3D conformal EBRT|External Beam Radiation Therapy
16407631|NCT02505750|Device|Contact X-ray brachytherapy 50 kV|
16407632|NCT02505750|Drug|Capecitabine|
16407633|NCT02493712|Drug|High dose|6 capsules of IBD98-M, twice a day
16407634|NCT02493712|Drug|Low dose|4 capsules of IBD98-M
16407635|NCT02493712|Drug|Placebo|Placebo
16407636|NCT02448485|Procedure|Aortic Valve Intervention (surgical or transcatheter)|Surgical or interventional aortic valve implantation
16407648|NCT02428985|Drug|Riociguat (ADEMPAS, BAY63-2521)|The treatment of Riociguat should comply with the local product information
16407649|NCT02427490|Behavioral|Problem-Solving Intervention|The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives. The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.
16407650|NCT02427490|Other|Unenhanced Monitoring|Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
16407651|NCT02423876|Drug|Epidural analgesia|"Receive epidural placement. Standard epidural medications and dosage are as follows:
~0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate
~3 mL/hr RN bolus, to be used as needed based on pain ratings
~3 mL/30 minutes patient bolus, which is available on patient demand."
16407652|NCT02423876|Other|Intraoperative Complication Management and Prevention|Undergo ERP
16407653|NCT02423876|Procedure|Pain Therapy|Undergo ERP
16407654|NCT02422550|Device|MRI|Participants enrolled on this protocol may undergo multiple MRI examinations periodically over the course of their treatment and follow-up if they are participating in a development project related to tumor response assessment. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility.
16407655|NCT02419378|Drug|Alemtuzumab|
16407656|NCT02401308|Procedure|Deep Brain Stimulation surgery|Deep Brain Stimulation surgery: awake vs. asleep
16407657|NCT02395640|Drug|Epirubicin|50mg/m2 ivgtt d1
16407658|NCT02395640|Drug|Oxaliplatin|
16407659|NCT02395640|Drug|Capecitabine|1000mg/m2 po d1-14
16407660|NCT02394275|Biological|Fecal Microbiota Transplant|All eligible patients will receive fecal microbiota transplant
16407661|NCT02381535|Drug|Cisplatin|Given IV
16407662|NCT02381535|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16407663|NCT02381535|Other|Laboratory Biomarker Analysis|Correlative studies
16407664|NCT02381535|Drug|Onalespib|Given IV
16407665|NCT02381535|Other|Pharmacological Study|Correlative studies
16407666|NCT02379611|Procedure|fNIRS (Functional Near Infrared Spectroscopy)|fNIRS is a non-invasive imaging method involving the quantification of chromophore concentration resolved from the measurement of near infrared (NIR) light attenuation, temporal or phasic changes. NIR spectrum light takes advantage of the optical window in which skin, tissue, and bone are mostly transparent to NIR light in the spectrum of 700-900 nm, while hemoglobin (Hb) and deoxygenated-hemoglobin (deoxy-Hb) are stronger absorbers of light. Differences in the absorption spectra of deoxy-Hb and oxy-Hb allow the measurement of relative changes in hemoglobin concentration through the use of light attenuation at multiple wavelengths.
16407667|NCT02374450|Procedure|Blood collection|For all hospitalised children suspected of having an AESI or meningitis, a sample of 5 ml of whole blood is collected and serum is stored.
16407668|NCT02363296|Device|TMS|Paired associative stimulation and single pulse TMS
16407669|NCT02356159|Biological|Rituximab|Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease
16407670|NCT02356159|Drug|Conditioning chemotherapy|Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3; Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3; Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3
16407671|NCT02356159|Drug|TMS|Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +60 if no acute GVHD then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 60, followed by a taper if GVHD does not develop.
16407672|NCT02356159|Drug|FLAG|Fludarabine: 25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
16407673|NCT02356159|Drug|EPOCH-F|Fludarabine: 25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4. Etoposide: 50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin: 10 mg/m2/day CIV, days 1-4. Vincristine: 0.4 mg/m2 per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide: 750 mg/m2 IV infusion over 30 minutes on day 5 Prednisone: 60 mg/m2 per day PO daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV.
16407674|NCT02356159|Procedure|Hematopoietic stem cell transplant|Hematopoietic stem cell transplant
16407680|NCT02312960|Other|Data Collection|No study treatment will be provided in this long term follow up study.
16407681|NCT02305303|Procedure|Diary|A diary written prospectively during the ICU stay by the staff and relatives
16407682|NCT02291432|Biological|autologous muscle-derived cells (AMDC)|Cell treatment
16407683|NCT02290951|Drug|Odronextamab multiple dose levels|Administered by intravenous (IV) infusion or subcutaneous (SC) injection
16407684|NCT02282371|Drug|Cetuximab|
16407685|NCT02282371|Drug|BYL719|
16407686|NCT02282371|Radiation|IMRT (Intensity-Modulated Radiation Therapy)|
16407687|NCT02281994|Device|Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD|Active devices emit PEMF signal; control devices do not emit PEMF signal.
16407688|NCT02266888|Biological|Rituximab (Rituxan®)|2 Doses: 375 mg/m^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).
16407689|NCT02266888|Biological|Placebo|Placebo for Rituximab (Rituxan®). 2 Doses: 375 mg/m^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).
16407690|NCT02239861|Biological|TAA-Specific CTLs|"Patients may be pre-medicated with Benadryl up to 1 mg/kg IV (max 50 mg) and Tylenol 10 mg/kg po (max 650 mg).
~Cell Administration: Tumor-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~Patients with stable disease or better will receive up to 6 further doses of CTLs, as long as they continue to show disease stabilization or improvement by RECIST criteria at their 8 week or subsequent evaluations. Each dose will consist of the same number as their second injection or less (if there is not enough product available for the subject's original dose).
~Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
16407694|NCT02233829|Drug|Brain Dopamine Reactivity|IV methylphenidate, used under IND #124, 912 is injected into the subject s bloodstream to be used in conjunction with PET imaging to show displacement of [11C]raclopride.
16407695|NCT02233829|Radiation|Brain Dopamine Receptor|The radiotracer [11C] raclopride is used for imaging dopamine receptors and dopamine release.
16407696|NCT02230410|Device|CryoBalloon Focal Ablation|
16407707|NCT02193425|Drug|F-18FDG|18F-Fluorodeoxyglucose (FDG)-PET session to assess the association between functional connectivity (FC) and glucose metabolism in the human brain.
16407708|NCT02193425|Device|MRI|Two MRI/MRS sessions to evaluate test-retest reliability of functional connectivity (FC) at rest as well as during task performance.
16407709|NCT02133196|Drug|Aldesleukin|Aldesleukin 720,000 (Arm 1) or 72,000 (Arm 2) IU/kg IV (based on total body weight) over 15 minutes every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to a maximum of 9 doses in Arm 1 and 12 doses in Arm 2.
16407710|NCT02133196|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
16407711|NCT02133196|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hour.
16407712|NCT02133196|Biological|Young TIL|Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
16407715|NCT02091882|Drug|Placebo|Oral placebo-embedded IEM tablet.
16407716|NCT02091882|Combination Product|Combination product of Aripiprazole + IEM + Sensor + MIND1 Application|Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone
16407717|NCT02068118|Device|Telecardiology program|"The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
~Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure."
16407795|NCT01059786|Drug|Pentostatin|28 patients to pentostatin 4 mg/m2 days 1 and 15 of each cycle.
16407796|NCT01059786|Drug|Rituximab|Rituximab 375 mg/m2 on day 1, 15 for 6 x 28-day cycles (all 72 patients)
16407718|NCT02020421|Device|rTMS|Low frequency (1Hz) repetitive transcranial magnetic stimulation (rTMS) over the center of the right Pars Triangularis for 15 minutes (900 pulses) prior to each Speech-Language therapy session. Stimulation intensity will be set at 90% of the resting motor threshold (RMT) of the left first dorsal interosseous (FDI) muscle.
16407719|NCT02020421|Device|tDCS|2mA cathodal transcranial direct current stimulation (tDCS) over the right Pars Triangularis. The anode will be placed on the forehead over the contralateral eye. tDCS will start immediately before the speech-language therapy session and last throughout the session.
16407720|NCT02020421|Device|Sham rTMS|Low frequency (1Hz) repetitive transcranial magnetic stimulation (rTMS) over the Vertex for 15 minutes (900 pulses) prior to each Speech-Language therapy session. Stimulation intensity will be set at 10% of the resting motor threshold (RMT) of the left first dorsal interosseous (FDI) muscle.
16407721|NCT02020421|Device|Sham tDCS|Sham cathodal transcranial direct current stimulation (tDCS) over the right Pars Triangularis. The anode will be placed on the forehead over the contralateral eye. To elicit the typical skin sensation of real tDCS (tingling sensation on the skin when tDCS is turned on and off), the current will be turned on for 30 seconds and then turned off for the duration of the speech-language therapy session. The same procedure will be done at the end of the session.
16407722|NCT02016924|Drug|ATV|Capsules administered once daily according to dosing recommendations per product monograph
16407723|NCT02016924|Drug|DRV|Tablets administered once daily according to dosing recommendations per product monograph
16407724|NCT02016924|Drug|Cobicistat|Tablets administered orally once daily with food
16407725|NCT02016924|Drug|BR|Prior to implementation protocol amendment 7, Background Regimen (BR) must include 2 nucleoside reverse transcriptase inhibitors (NRTI). After implementation of protocol amendment 7, BR must include 2 NRTIs and a third agent per local prescribing guidelines.
16407728|NCT01933958|Drug|Regorafenib (Stivarga, BAY73-4506)|The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
16407730|NCT01860183|Drug|Mycophenolate mofetil|Mycophenolate will be administered to all study patients at dose of 3 g daily for the first seven days posttransplant. Afterwards, study patients will continue, as randomized, on either 3 g, or 2 g MMF daily.
16407731|NCT01812694|Behavioral|Enhanced standard care|Standard prenatal care plus education
16407732|NCT01812694|Behavioral|Intensive lifestyle intervention|Intervention to limit excess gestational weight gain
16407733|NCT01799538|Drug|albuterol inhaler|2 puffs of Metered Dose inhaler for Bronchodilation
16407734|NCT01799538|Drug|albuterol nebulizer|Albuterol administered by nebulization will produce a greater increase in FEV1.
16407735|NCT01799538|Procedure|PFT|Breathing Test
16407736|NCT01687608|Biological|AskBio009|Single dose IV injection
16407737|NCT01665768|Drug|Everolimus|The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL.
16407738|NCT01665768|Biological|Rituximab|375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
16407739|NCT01615029|Drug|Part 1 (Dose Escalation): Daratumumab|Participants will receive intravenous (injection of a substance into a vein) infusion of daratumumab in an increased fashion from 2 milligram per kilogram (mg/kg) up to maximum dose of 16 mg/kg. Considering the safety and efficacy of dose in Part 1, recommended phase 2 dose (RP2D) for Part 2 of the study will be decided. A predose infusion of 10 percent (%) of the full dose of daratumumab will be administered a day before the first full infusion of the first cycle. Participants will receive 4 weekly infusions in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression.
16407740|NCT01615029|Drug|Part 2 (Dose Expansion): Daratumumab|Participants will receive RP2D as determined in Part 1 of the study. Participants will receive 4 weekly infusions of RP2D in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression.
16407741|NCT01615029|Drug|Lenalidomide|All participants (Part 1 and Part 2) will receive 25 mg lenalidomide orally (by mouth) from days 1 to 21 of each 28-day cycle until disease progression.
16407742|NCT01615029|Drug|Dexamethasone|All participants (Part 1 and Part 2) will receive 40 mg (20 mg intravenously [injection of a substance into a vein]) dexamethasone once weekly. Participants older than 75 years or underweight (body mass index [BMI] less than [<] 18.5), the dexamethasone dose will be administered at a dose of 20 mg once weekly until disease progression.
16407743|NCT01591590|Other|FDG PET-CT|All patients will undergo FDG PET-CT at inclusion and 2 weeks after
16407744|NCT01591590|Other|Diffusion MRI|All patients will undergo Diffusion MRI at inclusion and 2 weeks later
16407745|NCT01591590|Other|Blood samples (plasma preparation and CTC)|
16407746|NCT01581580|Procedure|Deep Brain Stimulation|standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor
16407748|NCT01508468|Drug|symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin)|Converting Enzyme inhibitor , Angiotensin II receptor antagonist, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin.
16407749|NCT01508468|Drug|experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)|NIST and IV infusion of Rituximab 375mg/m² at day (1) and day (8)
16407750|NCT01393821|Drug|menadione topical lotion|Given topically
16407751|NCT01393821|Other|placebo|Given topically
16407752|NCT01393821|Other|questionnaire administration|Ancillary studies
16407753|NCT01393821|Procedure|management of therapy complications|Given menadione topical lotion
16407797|NCT01059786|Drug|Bendamustine|28 patients to bendamustine 90 mg/m2/day, days 1 and 2 each cycle
16407755|NCT01351545|Drug|A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)|A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
16407756|NCT01321177|Behavioral|Integrated Treatment|"Integrated program of treatments and services delivered by a coordinated team of providers that includes:
~education about schizophrenia and its treatment for the participants and their family members
~medication for symptoms and preventing relapse that uses a computerized decision support system
~strategies for managing the illness and building personal resilience
~help getting back to school or work using a supported employment/education model"
16407757|NCT01321177|Behavioral|Community Care|"Standard mental health treatments and services offered at the local agency that may include :
~medication for symptoms and preventing relapse
~psychosocial therapy which may include a range of behavioral treatments and supportive services
~Case management"
16407768|NCT01263951|Drug|Everolimus|One 5 mg. tablet daily.
16407769|NCT01263951|Drug|Sorafenib|200 mg. twice daily.
16407770|NCT01261247|Drug|panobinostat|Given orally
16407771|NCT01261247|Other|laboratory biomarker analysis|Correlative studies
16407772|NCT01261247|Genetic|western blotting|Correlative studies
16407773|NCT01261247|Genetic|DNA analysis|Correlative studies
16407774|NCT01261247|Other|flow cytometry|Correlative studies
16407775|NCT01261247|Other|pharmacological study|Correlative studies
16407776|NCT01261247|Other|immunohistochemistry staining method|Optional correlative studies
16407777|NCT01224704|Other|Hypertonic saline infusion|Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.
16407778|NCT01224704|Other|Water deprivation|24 hour water deprivation
16407779|NCT01222754|Drug|Lenalidomide|"With radiation therapy five days per week, concurrent doses of lenalidomide daily in a standard Phase I dose escalation design.
~Maintenance dosing of lenalidomide, post-radiation, for 21 days of a 28 day course."
16407780|NCT01222754|Radiation|XRT, 54-59.4 Gy|Radiation therapy five days per week to a prescription dose of 54-59.4 Gy, with concurrent administration of lenalidomide
16407781|NCT01176006|Procedure|Reduced-intensity hematopoietic stem cell|stem cell transplant
16407782|NCT01176006|Drug|Fludarabine(Fludara, Berlex Laboratories)|40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
16407783|NCT01176006|Drug|Cyclophosphamide(CTX, Cytoxan)|14.5 mg/kg IV (in the vein) infusion over 30 min on days -6, and -5
16407784|NCT01176006|Procedure|Total Body Irradiation (TBI)|200 cGy on Day -1
16407785|NCT01176006|Drug|Busulfan (Busulfex)|3.2 mg/kg IV (in the vein) over 2 hours once daily on Days -6, -5, -4 and -3 (weight based dosing) or on days -4, -3 and -2
16407786|NCT01176006|Procedure|Donor peripheral blood stem cell mobiliation and collection|Donors undergo peripheral blood stem cell (PBSC) collection by apheresis will have their CD34 cells mobilized into the blood with filgrastim (Neupogen, Amgen)
16407787|NCT01176006|Procedure|Bone Marrow Harvest Procedure|Bone marrow from haploidentical related donors, and, in some cases, matched related donors will be harvested under routine conditions in the operating room. General or spinal anesthesia will be employed.
16407788|NCT01158885|Drug|Clofarabine|20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.
16407789|NCT01158885|Drug|Cytarabine intravenous|1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.
16407790|NCT01158885|Drug|Methotrexate|"Methotrexate to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age below:
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
16407791|NCT01158885|Drug|Intrathecal (IT) Cytarabine|"Intrathecal (IT) cytarabine is optional for acute myelogenous leukemia (AML) patients.
~If intrathecal cytarabine is to be given, it must be given at least 72 hours but not more than 7 days prior to the initiation of intravenous cytarabine.
~Dose should be given according to age as defined below:
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age"
16407792|NCT01111552|Drug|Escitalopram|Escitalopram oral capsules.
16407793|NCT01111552|Drug|Aripiprazole|Aripiprazole oral capsules.
16407794|NCT01111552|Drug|Placebo|Study drug matching placebo capsule.
16407923|NCT05096702|Drug|Tafenoquine|Tafenoquine 300 mg (2x150mg tablets)
16407800|NCT00983398|Drug|Carboplatin|Given IA
16407801|NCT00983398|Drug|Mannitol|Given IA
16407802|NCT00983398|Drug|Melphalan|Given IA
16407803|NCT00983398|Other|Quality-of-Life Assessment|Ancillary studies
16407804|NCT00983398|Other|Questionnaire Administration|Ancillary studies
16407805|NCT00983398|Drug|Sodium Thiosulfate|Given IV
16407808|NCT00887432|Dietary Supplement|Cholecalciferol|Given PO
16407809|NCT00887432|Other|Laboratory Biomarker Analysis|Correlative studies
16407810|NCT00887432|Other|Patient Observation|
16407811|NCT00887432|Drug|Placebo Administration|Given PO
16407812|NCT00887432|Other|Quality-of-Life Assessment|Ancillary studies
16407813|NCT00887432|Other|Questionnaire Administration|Ancillary studies
16407814|NCT00853502|Drug|testosterone cypionate|dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months
16407815|NCT00827151|Drug|Estrogen|Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication
16407818|NCT00795080|Procedure|Dynamic cervical MRI scans|Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)
16407821|NCT00720785|Drug|Bortezomib|Parenteral formulation. It is supplied as a 3.5 mg single use vial containing a sterile lyophilized powder that requires reconstitution.
16407822|NCT00720785|Biological|NK cells|NK Cell Infusion
16407823|NCT00674882|Other|Data Collection|Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study
16407824|NCT00669188|Other|Information absent|Information
16407825|NCT00669188|Other|Information|Information
16407826|NCT00663611|Drug|Norditropin|Norditropin (somatropin, rDNA origin) is a polypeptide hormone of recombinant DNA origin. The amino acid sequence of the product is identical to that of the human growth hormone of pituitary origin.
16407827|NCT00663611|Drug|Placebo|0.9% normal saline
16407828|NCT00612352|Drug|Ethanol High Dose, Ethanol Low Dose, and Placebo|Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.
16407829|NCT00592501|Radiation|Proton/Photon Radiotherapy|Given once a day, five days a week, for seven weeks.
16407830|NCT00592501|Drug|Cisplatin|Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
16407831|NCT00592501|Drug|Fluorouracil|Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.
16407832|NCT00522535|Procedure|Open surgical repair|Open surgical repair of abdominal aortic aneurysm
16407833|NCT00522535|Device|Stent Graft|Endovascular repair of abdominal aortic aneurysm (EVAR)
16407834|NCT00504582|Drug|Fibrin Sealant|Tisseel applied externally to the dissected axillary area.
16407835|NCT00381641|Other|Laboratory Biomarker Analysis|Optional correlative studies
16407836|NCT00381641|Other|Pharmacogenomic Study|Optional correlative studies
16407837|NCT00381641|Drug|Sunitinib|Given PO
16407838|NCT00381641|Drug|Sunitinib Malate|Given PO
16407839|NCT00334815|Biological|Bevacizumab|Given IV
16407840|NCT00334815|Drug|Cisplatin|Given IV
16407841|NCT00334815|Drug|Docetaxel|Given IV
16407842|NCT00334815|Drug|Etoposide|Given IV
16407843|NCT00334815|Biological|Filgrastim|Given SC
16407844|NCT00334815|Biological|Pegfilgrastim|Given SC
16407845|NCT00334815|Radiation|Radiation Therapy|Undergo thoracic radiotherapy
16407846|NCT00286234|Drug|omega-3 acid ethyl esters|4 q qd
16407847|NCT00286234|Drug|extended release niacin|2 g qpm
16407848|NCT00286234|Drug|placebo|omacor placebo plus niaspan placebo
16407849|NCT00286234|Drug|omega-3 acid ethyl esters|4 g qd
16407850|NCT00286234|Drug|combined treatment|omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
16407851|NCT00282685|Procedure|Intraarterial bone marrow progenitor cell transplantation|catheter delivery of stem cells
16407852|NCT00282646|Procedure|intraarterial stem cell therapy|catheter delivery of stem cells
16407853|NCT00282646|Other|Stem cells|intraarterial application of bone marrow mononuclear cells versus placebo
16407854|NCT00217737|Biological|Bevacizumab|Given IV
16407855|NCT00217737|Drug|Fluorouracil|Given IV
16407856|NCT00217737|Other|Laboratory Biomarker Analysis|Correlative studies
16407857|NCT00217737|Drug|Leucovorin Calcium|Given IV
16407858|NCT00217737|Drug|Oxaliplatin|Given IV
16407859|NCT00193050|Drug|Gemcitabine|Gemcitabine
16407860|NCT00193050|Drug|Epirubicin|Epirubicin
16407861|NCT00193050|Drug|Docetaxel|Docetaxel
16407862|NCT00109174|Device|3T and 7T device|3T and 7T device
16407865|NCT00055224|Device|Acoustic startle|Threat condition
16407866|NCT00055224|Device|Electric Shock|Threat condition
16407867|NCT00047853|Device|Shock device|Electric shock stimulus
16407868|NCT00047853|Device|Acoustic startle|Acoustic startle for MEG only
16407869|NCT00044304|Drug|Imatinib|The dosing regimen to be used initially (400 mg po qd in adults and 260 mg/m2/day in children with food and a glass of water) is identical to that recommended by the FDA for the treatment of the chronic phase of chronic myelogenous leukemia (CML) (Prod Info Gleevec ). In patients with ANC<1500/mm3, platelet counts < 75,000mm3 or abnormal liver function tests (ALT or AST > 2.5 or bilirubin > 3 times the upper limit of normal), the starting dose will be reduced to 300 mg poqD.
16407870|NCT00044304|Drug|Ruxolitinib|The dosing regimen to be used initially (15 mg po bid) is identical to that recommended by the FDA for the treatment of myelofibrosis with platelet counts of 100-200,000/mm3 (Prod Info ruxolitinib). In patients with platelet counts <100,000/mm3, moderate renal impairment (CrCl <60 ml/min) or abnormal liver function tests (AlT or AST > 2.5 or bilirubin > 3 times the upper limit of normal), the starting dose will be reduced to 10 mg bid. The recommended guidelines for dose adjustment during therapy and discontinuation of therapy in myelofibrosis will be followed.
16407875|NCT00001337|Drug|EPOCH|Combination chemotherapy given with Rituximab (EPOCH-R) IV every 3 weeks for 6 cycles.
16407876|NCT00001337|Biological|Rituximab|Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles.
16407878|NCT05097118|Drug|Ketamine Versus Bupivacaine|Drugs Ketamine versus Bupivacaine
16407879|NCT05097105|Device|MRI|MRI sequences: TI. T2 and diffusion weighted
16407880|NCT05097092|Procedure|Orthopedic immobilization|Orthopedic immobilization will be performed with a sling and swathe.
16407881|NCT05097092|Other|Unilateral resistance training|Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.
16407882|NCT05097092|Other|Bilateral resistance training|Bilateral resistance training will be performed by both arms in both groups during Phase 2.
16407883|NCT05097079|Drug|MYOBLOC Low Dose|Weight-based dose; 5.0 units/kg for submandibular gland and 25.0 units/kg for parotid gland
16407884|NCT05097079|Drug|MYOBLOC High Dose|Weight-based dose; 10.0 units/kg for submandibular gland and 40.0 units/kg for parotid gland
16407885|NCT05097079|Drug|Placebo|volume-matched placebo
16407886|NCT05097066|Procedure|Neurosurgical procedure|Any neurosurgical procedure in the National Neurosurgical Audit Programme (NNAP) Coding Framework of neurosurgical procedures.
16407887|NCT05097053|Biological|MVC-COV1901(3 Months)|MVC-COV1901 vaccine after a 3-month Interval
16407888|NCT05097053|Biological|MVC-COV1901(6 Months)|MVC-COV1901 vaccine after a 6-month Interval
16407889|NCT05097040|Behavioral|acceptance and commitment therapy (ACT)|The intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 6 weeks through Zoom videoconferencing. Also, a one-time 1-hour booster session will be provided at 1-month follow-up to facilitate the maintenance of treatment effects.
16407890|NCT05097027|Device|Blood flow restriction recovery|Soccer players included in experimental group I will carry out this program for 1 week using 160mmHg blood pressure. After a month they will carry out the program without restriction of blood flow. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.
16407891|NCT05097027|Other|Active recovery|Soccer players included in experimental group II will carry out this program for 1 week. After a month they will carry out the program with blood flow restriction. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.
16407892|NCT05097014|Drug|CHF5993|Pressurized metered dose inhaler (pMDI) 2 inhalations bid
16407893|NCT05097014|Drug|CHF1535|Pressurized metered dose inhaler (pMDI) 2 inhalations bid
16407894|NCT05097014|Other|Matched placebo|Pressurized metered dose inhaler (pMDI) 2 inhalations bid
16407895|NCT05097001|Other|DBS programming|DBS readjustment based on COMPUTER or CLINICAL program
16407924|NCT05096702|Drug|Primaquine|Daily primaquine adjusted by weight (0.5 mg/kg/day for 7 days)
16407925|NCT05096702|Drug|Primaquine|Weekly primaquine adjusted by weight (0.75mg/kg/week for 8 weeks)
16407926|NCT05096689|Other|MRI|Magnetic Resonance Imaging
16407927|NCT05096676|Drug|Oxytocin: Including placebo|Individual received age-dependent dosing of oxytocin and placebo. Participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU.
16407928|NCT05096663|Dietary Supplement|Cobalamin|Given intramuscularly
16407897|NCT05096975|Other|Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED|"The intervention involves the completion of two questionnaires by parents at child psychiatry unit of Montpellier University Hospital when children come to participate in a psychometric assessment or when parents or children participate in therapeutic group.
~All parents completed Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001), a 118-item questionnaire to measure emotional and behavior problems in 4 to 18-years-old children in the past six months and Hierarchical Personality Inventory for Children (HiPIC, Mervielde & De Fruyt, 1999, a 144-item questionnaire to obtain a profile of the personality of 6 to 12-year-old children."
16407898|NCT05096962|Diagnostic Test|Quantitative analysis of SARS-CoV-2 antibodies|The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).
16407899|NCT05096962|Diagnostic Test|Cellular immunity|Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
16407900|NCT05096949|Other|Home visit delivery strategy|A nurse will deliver and administer Cabenuva injection at patient's home
16407901|NCT05096936|Other|Pilates|"The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:
~20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front."
16407902|NCT05096936|Other|Photobiomodulation|Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.
16407903|NCT05096910|Procedure|Uterine Closure with monofilament or polyfilament suture materials|Postoperative 6th-month isthmocele rates
16407904|NCT05096897|Other|Self-administrated questionnaires|GOHAI, IBD-Q, IBD-disk
16407905|NCT05096884|Drug|Metoprolol Succinate|The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
16407906|NCT05096871|Genetic|Genotyping by Real Time PCR|"3 mL of blood will be withdrawn by venipuncture in EDTA tube. DNA extraction will be done after centrifugation and used for genotyping assay of ( BDNF ) gene with the Real- time polymerase chain reaction.
~BDNF level in serum will also be analyzed by Sandwich enzyme linked immunosorbant assay kit ( ELISA)."
16407907|NCT05096845|Biological|Recombinant SARS-CoV-2 fusion protein vaccine (V-01)|"Appearance: creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively.
~Storage condition: store at 2~8°C protected from light Expiry date: 24 months after production date"
16407908|NCT05096845|Other|Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)|The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.
16407911|NCT05096819|Other|App|Use of an App to measure 6MWT distance
16407912|NCT05096806|Other|Acupuncture|Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.
16407913|NCT05096806|Device|TENS|TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.
16407914|NCT05096793|Dietary Supplement|beta alanine|On day 1, all participants completed the 6-MRT corresponding to baseline. Then, on days 2 and 3, each participant performed the 6-MRT with 30 mg·kg-1 and 45 mg·kg-1 of BA (low and high-dose trials, respectively). BA was purchased in powder format from a factory specializing in sports supplements. BA was colorless when diluted in water and had a characteristic taste. This format of BA (powder) allowed personalized dosing for each participant. The research team performed the personalized dosing before the application of the treatment. Between the evaluation days, there was 72 hours difference. The 30 mg·kg-1 or 45 mg·kg-1 BA administration was done with a double-blind method. Thus, on day 2, 50% of the sample performed the 6-MRT supplemented with 30 mg·kg-1 BA, while the other 50% performed the 6-MRT with 45 mg·kg-1 BA. On day 3, those participants who completed the 6-MRT with 30 mg·kg-1 BA now performed with 45 mg·kg-1 BA and vice versa.
16407915|NCT05096780|Other|Flavored caffeinated beverage|16.9 oz (500 cc), carbonated, zero calorie
16407916|NCT05096767|Other|questionnaires and inventories|questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed
16407917|NCT05096754|Device|OCS Liver|Transplant with an OCS preserved liver.
16407918|NCT05096741|Device|OCS Liver|Transplanted with a OCS preserved liver
16407919|NCT05096728|Drug|Nifedipine XL|"Patients will be enrolled when the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. Participants will be randomized in to one of two groups
~Once daily Nifedipine XL 60mg Vs.
~Twice daily Nifedipine XL 30mg"
16407920|NCT05096715|Drug|Atezolizumab|Intravenous Infusion
16407921|NCT05096715|Drug|Bevacizumab|Intravenous Infusion
16407922|NCT05096715|Radiation|Stereotactic body radiation therapy (SBRT)|External Beam Radiation
16407929|NCT05096663|Drug|Dexamethasone|Given orally (PO)
16407930|NCT05096663|Drug|Docetaxel|Given IV
16407931|NCT05096663|Dietary Supplement|Folic Acid|Given PO
16407932|NCT05096663|Drug|Gemcitabine|Given IV
16407933|NCT05096663|Drug|Nogapendekin Alfa|Given SC
16407934|NCT05096663|Biological|Pembrolizumab|Given IV
16407935|NCT05096663|Drug|Pemetrexed|Given IV
16407936|NCT05096663|Biological|Ramucirumab|Given IV
16407937|NCT05096650|Procedure|mesotherapy of platelet rich plasma and platelet poor plasma|Each case will receive 3 sessions of injection therapies with one month interval. Each case will receive platelet rich plasma therapy on one side of the face. The other side of the face was treated with platelet poor plasma.
16407938|NCT05096637|Other|PreventiPlaque App|PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
16407939|NCT05096624|Other|DD-TENS system|Use of DD-TENS system
16407940|NCT05096624|Other|Gold Standard|Gold standard
16407941|NCT05096624|Other|Digital Denture system|Use of Digital Denture system
16407942|NCT05096611|Behavioral|Attachment and Biobehavioral Catch up|ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship.
16407943|NCT05096611|Behavioral|Attachment and Biobehavioral Catch up Plus Depression Treatment|ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood.
16407944|NCT05096598|Drug|ZP8396|Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.
16407945|NCT05096598|Drug|Placebo (ZP8396)|Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).
16407946|NCT05096585|Behavioral|Delayed bedtime sleep restriction|bedtime 2 hr later than their normal bedtime
16407947|NCT05096585|Behavioral|Early wake sleep restriction|wake time 2 hr earlier than their normal wake time
16407948|NCT05096572|Device|VIM Stimulation|Subjects will receive stimulation at VIM site only based on best settings ascertained during monopolar review.
16407949|NCT05096572|Device|PSA Stimulation|Subjects will receive stimulation at PSA site only based on best settings ascertained during monopolar review.
16407950|NCT05096572|Device|VIM+PSA Stimulation|Subjects will receive stimulation at VIM+PSA based on best settings ascertained during monopolar review.
16407951|NCT05096559|Device|Microcirculation cytocam|Visualization of tongue microcirculation
16407952|NCT05096546|Other|No intervention|No intervention will be applied for the observational study.
16407953|NCT05096520|Procedure|radiofrequency|the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the Baylis brand radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.
16407954|NCT05096520|Procedure|control|The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.
16407955|NCT05096520|Drug|2% lidocaine|2% lidocaine
16407956|NCT05096507|Procedure|Hip fracture Surgery (Primary)|Surgery for primary hip fracture requiring general or neuro-axial anaesthesia
16407957|NCT05096494|Drug|SP-103|SP-103 is worn daily for 12 hours per day, for 28 days
16407958|NCT05096494|Drug|Placebo|Placebo is worn daily for 12 hours per day, for 28 days
16407959|NCT05096481|Biological|PEP-CMV|The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.
16407960|NCT05096481|Drug|Temozolomide|Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1
16407961|NCT05096481|Biological|Tetanus Diphtheria Vaccine|Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.
16407962|NCT05096468|Drug|S-ketamine and pregabalin|"Drug: Pregabalin
~150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14)
~Drug: S-ketamine infusion
~0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h"
16407963|NCT05096468|Drug|Normal saline and placebo capsule|"Drug: Placebo capsules
~Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
~Drug: Normal saline
~0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours"
16407964|NCT05096442|Device|GENOSS® DCB|Drug Coated Balloon
16407965|NCT05096442|Device|SeQuent® Please NEO|Drug Coated Balloon
16407966|NCT05096429|Behavioral|PROVIDENT|Each of the state's 39 municipalities will be randomised to the intervention (PROVIDENT) or comparator condition. An interactive, web-based tool will be developed to visualize the PROVIDENT model predictions. Municipalities assigned to the treatment arm will receive neighborhood risk predictions from the PROVIDENT model, and state agencies and community-based organizations will direct resources to neighborhoods identified as high risk. Municipalities assigned to the control arm will continue to receive surveillance information and overdose prevention resources, but they will not receive neighborhood risk predictions from this study.
16408063|NCT05095584|Diagnostic Test|3 meter backward walk test|validity and reliability of 3-meter backward walk test in lower limb amputation group
16408535|NCT04884360|Drug|Olaparib|Olaparib tablets 300 mg oral twice daily
16407967|NCT05096416|Device|The three-dimensional (3D) printed hemodialysis vascular model|The three-dimensional (3D) printed hemodialysis vascular model will be used as a guide map to cannulate the patients for hemodialysis and to minimize the risk of vascular access complications
16407968|NCT05096403|Drug|Pegcetacoplan|Pegcetacoplan taken twice weekly as subcutaneous injection
16407969|NCT05096390|Drug|Axitinib Oral Tablet [Inlyta]|Axitinib 5 up to 10mg twice a day
16407970|NCT05096390|Drug|Pembrolizumab Injection [Keytruda]|Pembrolizumab intravenously over 30 min minutes at 200 mg every 3 weeks
16407971|NCT05096377|Other|ESP block|ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
16407972|NCT05096364|Biological|AK111/Placebo|After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
16407973|NCT05096351|Other|Blood test|Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies
16407974|NCT05096338|Other|Social Determinants of Health|We will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
16407975|NCT05096325|Device|YpsoPump® insulin pump system|The subjects will receive a CE-certified mylife™ YpsoPump® insulin pump system that allows detailed logging of pressure data. Data will then be analysed in silico comparing the new occlusion detection algorithm with the common occlusion detection algorithm.
16407976|NCT05096312|Dietary Supplement|Zinc gluconate|oral zinc gluconate 200mg
16407977|NCT05096312|Drug|Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]|Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
16407978|NCT05096312|Other|Placebo|contains cornstarch
16407979|NCT05096299|Device|OCS Heart|Transplanted with OCS preserved heart.
16407981|NCT05096273|Behavioral|ReACT|ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations
16407982|NCT05096260|Behavioral|Motivational Interviewing of SMS and web content|Our primary framework that will guide the web content is Self-Determination Theory (SDT). SDT differentiates between autonomous (conscious choice and are personally relevant) and controlled behavioral regulation (performed due to pressure or coercion by external or internal forces). Messages that enhance autonomy and perceived competence and are consistent with a person's values and goals will be more effective in changing behavior than messages focusing on external rewards. To link vaccination to broader values and goals, participants will select 3-4 goals from approximately 20 values/goals. Individually tailored messages will link each of these values to vaccination. We will also tailor testimonials based on member values and communication style preference.
16407983|NCT05096247|Device|TempSure|This device is an RF device.
16407984|NCT05096247|Device|Icon|This device works with IPL (Intense Pulsed Light) handpieces.
16407985|NCT05096234|Drug|[ 18F]F-AraG PET|Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)
16407986|NCT05096221|Genetic|SRP-9001|Single IV infusion of SRP-9001.
16407987|NCT05096221|Genetic|Placebo|Single IV infusion of matching placebo.
16407988|NCT05096208|Biological|RSVpreF (Group 1)|RSV vaccine (RSVpreF)
16407989|NCT05096208|Biological|RSVpreF (Group 2)|RSV vaccine (RSVpreF)
16407990|NCT05096208|Biological|RSVpreF (Group 3)|RSV vaccine (RSVpreF)
16407991|NCT05096208|Biological|Placebo|Placebo
16407992|NCT05096195|Drug|Denosumab 60 mg/ml [Prolia]|Denosumab 60 mg (Prolia) every 6 months
16407993|NCT05096195|Other|Calcium and vitamin D prophylaxis|Per protocol adjustment of calcium dialysate and intravenous (IV) calcitriol and replacement of 25 hydroxyvitamin D (if indicated)
16407994|NCT05096195|Diagnostic Test|Monitoring of calcium and phosphate|Serum calcium and phosphate for 4 weeks following each denosumab injection.
16407995|NCT05096169|Drug|Clomiphene Citrate 25mg|clomiphene citrate at a dose of 25mg daily
16407996|NCT05096169|Drug|Clomiphene Citrate 50mg|clomiphene citrate at a dose of 50mg every other day
16407997|NCT05096156|Device|Biofinity® Monthly Replacement Contact Lens|Soft, spherical contact lens used to correct distance vision.
16407998|NCT05096156|Device|Precision1® Daily Disposable Contact Lens|Soft, spherical contact lens used to correct distance vision.
16407999|NCT05096143|Drug|Sacubitril/valsartan|Participants who were prescribed with Sacubitril/valsartan
16408000|NCT05096143|Drug|ACEi/ARB|Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
16408001|NCT05096130|Behavioral|Lifestyle Medicine Strategies|"LM addresses health risk factors in primary, secondary, and tertiary prevention of developing disease rather than limiting resources and medical expenditures on acute care and reacting to illness, injury, and disease.
~The intervention will target the four pillars of the LM approach including physical activity, diet, stress, and sleep. Certified in LM strategies professionals will consult participants from the LM group in a biweekly base in order to improve their lifestyle habits."
16408002|NCT05096117|Drug|ASP8062|ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
16408003|NCT05096117|Drug|Placebo|1 x per day for 6 weeks
16408004|NCT05096078|Other|Diet|Special diet program for gestational diabetes
16408005|NCT05096078|Other|Exercise|The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.
16408006|NCT05096065|Drug|Leuprolide Oral Tablet - 120 mg - QD- Treatment A|"If the subject during Treatment A meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of the First Treatment Cycle), in the Second Treatment Cycle, she will be assigned Treatment B - 80 mg (2 x 40 mg tablets) (QD), with food-intake restrictions.
~If the subject during Treatment A fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the First Treatment Cycle), then she will be switched to the Second Treatment Cycle with Treatment D - 60 mg (BID) with food intake restrictions."
16408007|NCT05096065|Drug|Leuprolide Oral Tablet - 80 mg - QD - Treatment B|"If the subject on Treatment B meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment C - 60 mg (QD) with food-intake restrictions.
~If the subject on Treatment B does not meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment E - 40 mg (BID) with food intake restrictions."
16408008|NCT05096065|Drug|Leuprolide Oral Tablet - 60 mg - QD - Treatment C|For up to 29 consecutive days with food-intake restrictions
16408009|NCT05096065|Drug|Leuprolide Oral Tablet - 60 mg - BID - Treatment D|"If the subject on Treatment D fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), she will be discontinued from the study following completion of the Second Treatment Cycle.
~If the subject during Treatment D meets the pharmacodynamic success criterion (estradiol level <20 pg/mL on Treatment Day 29 of her Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment E - 40 mg (BID) with food intake restrictions."
16408010|NCT05096065|Drug|Leuprolide Oral Tablet - 40 mg - BID - Treatment E|For up to 29 consecutive days with food-intake restrictions
16408011|NCT05096052|Drug|Galactomannan|Precise chemistry based molecule that binds to galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
16408012|NCT05096052|Drug|PLACEBO|A blinded matching placebo containing inert chemistry not able to recognise and bind to the galectin like receptors on the N terminal of S1 subunit of the Sars-CoV2 virus
16408013|NCT05096039|Drug|Sacubitril/valsartan|Beneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan (from the PDE file) during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'
16408014|NCT05096039|Drug|ACEI or ARB and no sacubitril/valsartan|Beneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'
16408015|NCT05096026|Behavioral|Standard PCP Outreach|These patients were sent two study outreach messages. Study Outreach 1 was an electronic secure message sent on behalf of the PCP, encouraging COVID-19 vaccination and designed based on behavioral science principles. Letters were sent to patients who had not signed up for the electronic health record portal. Study Outreach 2 was a postcard sent to all patients who had not been vaccinated or made an appointment by four weeks after Study Outreach 1.
16408016|NCT05096026|Behavioral|Culturally Tailored PCP Outreach|These patients were sent messages similar to those in Standard PCP Outreach, but with additional culturally tailored content and photos.
16408017|NCT05096013|Other|individual nutritional therapy|Intervention arm: Usual care + individualized nutritional therapy. Patients at risk for malnutrition and sarcopenia will receive a counselling by the nutritional therapist twice a week. The therapists will assess the patient's energy and protein demand in order to develope appropriate individual measures (e.g additional meals or supplements) to increase patients' energy and protein intake. Individual nutritional therapy is already usual care in patients with high risk for malnutrition, but not for patients with only light to moderate risk of malnutrition and risk of sarcopenia.
16408018|NCT05096000|Behavioral|InterMob: a randomized controlled trial aimed at reducing car use in regular car users|Intermob is a theory- and evidence-based behavioral intervention that combines public transport/bicycle and motivational techniques (action planning, personalized transport advice, goal setting).
16408019|NCT05096000|Other|Active control: Air pollution information|The active control intervention is based on a discussion about air pollution, the effects of air pollution on health, the association between air pollution and transport.
16408020|NCT05095987|Procedure|Laparoscopic Appendectomy|Laparoscopic Appendectomy for acute uncomplicated appendicitis in children
16408021|NCT05095974|Device|ultrasonography|Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.
16408022|NCT05095974|Device|echocardiography|MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.
16408023|NCT05095974|Device|thoracic electrical bioimpedence|EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.
16408024|NCT05095961|Drug|Prednisone|5 day course of oral prednisone pre-operatively. 30mg per day.
16408025|NCT05095948|Procedure|Discussion|Undergo audio recording of clinic conversations
16408026|NCT05095948|Other|Electronic Health Record Review|Review of medical records
16408027|NCT05095948|Other|Questionnaire Administration|Complete questionnaires
16408028|NCT05095935|Other|N/A observational registry|N/A observational registry
16408029|NCT05095922|Drug|Heart-Protecting Musk Pill|Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months) Valsartan（capsule, 80mg, once a day, 3 months） Calcium Dobesilate (tablet, 500mg, three times a day, 3 months)
16408030|NCT05095909|Device|Cryo-compression|Programmable intermittent compression with integrated cryo-therapy.
16408031|NCT05095909|Other|Cryo-therapy|Subjects are fitted with gel ice packs and wraps.
16408032|NCT05095896|Other|ITP patients|ITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
16408033|NCT05095870|Other|No intervention|Pure observational study
16408172|NCT05085535|Other|Exercise|Exercises for body mobility and muscle toning, Sophrology
16408034|NCT05095857|Drug|S-ketamine|S-ketamines is an NMDA-receptor antagonist with sedative and analgesic properties. It will in the present trial be given in sedative doses (2-3 mg/kg/hour) in case of clustered SDs following a dosing algorithm according to SD occurrence.
16408035|NCT05095857|Other|Isotonic saline (placebo)|Isotonic saline has the same appearance as S-ketamine with both being clear liquids with no bubbles or other distinguishing features.
16408036|NCT05095844|Biological|vaccinated|Pfizer-BioNTech COVID-19 Vaccine, Moderna or J&J/Janssen COVID-19 Vaccine, Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) Hepatitis A (e.g., HAV) Hepatitis B (e.g., HBV) Human papillomavirus (e.g., HPV) Seasonal influenza (e.g., Flu) Measles (e.g., MMR) Mumps (e.g., MMR, MR, M) Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) Pertussis (e.g., DTP, DTaP, Tdap) Pneumococcal conjugate (e.g., PCV) Polio (e.g., OPV or IPV) Rotavirus (e.g., RV) Rubella (e.g., MMR, MR, R) Tetanus (e.g., Td) Varicella (e.g., VAR)
16408037|NCT05095831|Diagnostic Test|Pancreas EUS shear wave|"EUS Shear wave elastography (SWE) is a form of ultrasound elastography used in transabdominal ultrasonography. It measures tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI). The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals [kPa] or meters per second. Also, the dispersion slope or ultrasound shear wave dispersion (SWD) will be recorded. It is the measure of viscosity [(m/sec)/kHz] using SWE.
~A first endoscopist will perform EUS over pancreas tissue. Without any elastography assessment (strain ratio/histogram) , the endoscopist will take ten shear wave measurements of pancreas tissue elasticity by generating shear waves inside the pancreas using the ARFI."
16408038|NCT05095831|Diagnostic Test|Pancreas EUS-elastography and EUS-guided biopsy|"Pancreas EUS-elastography measures the pancreatic tissue stiffness through strain ratio (SR) and strain histogram (SH).
~A second endoscopist blind to pancreas tissue shear wave findings will perform EUS-elastography with corresponding SR and SH measurements. The SR/SH will be measured and documented. Finally, a pancreas tissue biopsy will be performed. The impossibility of biopsy is an exclusion criterion (except in control patients). Due to ethical purposes, a biopsy will not be performed on patients from the control group."
16408039|NCT05095818|Other|PrEP-RN|Patients randomized to the intervention arm will be counseled on HIV risk factors in general, their HIV risk factors in particular, and prevention methods, inclusive of PrEP (Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg).
16408040|NCT05095805|Behavioral|additional weight-bearing exercise|Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
16408041|NCT05095805|Behavioral|standard weight-bearing exercise|conventional training for fitting of initial prosthesis
16408042|NCT05095792|Other|Observational - no intervention|This is an observational study with no intervention.
16408043|NCT05095779|Behavioral|Standard Care + Financial Incentives|Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
16408044|NCT05095779|Other|Standard Care|Financial Incentives participants will receive standard care for completing counseling calls and for biochemically-verified smoking abstinence.
16408045|NCT05095753|Device|Earbud|In ear headphone with embedded infrasonic hemodynography technology
16408046|NCT05095740|Device|repetitive transcranial magnetic stimulation (rTMS)|Repetitive transcranial magnetic stimulation used to regulate the contribution of the laryngeal motor cortex to voice production and laryngeal motor muscle activation.
16408047|NCT05095740|Device|sham rTMS|Repetitive transcranial magnetic stimulation used to a cortical area not associated with change in outcomes at an intensity substantially lower than that of the established threshold.
16408048|NCT05095727|Drug|mRNA-3745|Sterile frozen liquid dispersion for injection
16408049|NCT05095714|Other|Liver ultrasound and fast-MRI|Half-yearly liver ultrasound and fast-MRI
16408050|NCT05095714|Other|Liver ultrasound|Half-yearly liver ultrasound
16408051|NCT05095701|Biological|Investigational Live Attenuated Varicella Vaccine|The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
16408052|NCT05095701|Biological|Placebo (Freeze Dired Dilution)|The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
16408053|NCT05095675|Behavioral|psychological questionnaires|Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment
16408054|NCT05095649|Biological|Regulatory T-cell enriched infusion|Enrichment of CD25hi regulatory T cells from cluster of differentiation antigen 8 and/or cluster of differentiation antigen19 pre-depleted leukapheresis products.
16408055|NCT05095636|Drug|Apatinib Mesylate|oral Apatinib once everyday
16408056|NCT05095636|Drug|Camrelizumab|intravenous camrelizumab 200mg once every two weeks
16408057|NCT05095623|Other|Natural History Observation|This is a natural history study.
16408058|NCT05095610|Device|Flash|Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.
16408059|NCT05095597|Procedure|Injection of hUC-PRP by hysteroscopy|PRP previously frozen at -80ºC (6±2 mL) will be defrozen after checking donor-receptor compatibility and viral safety study. PRP (4±2 mL) will be activated with 5% CaCl2 and immediately injected (4±2 mL) in the sub-endometrial wall via hysteroscopy.
16408060|NCT05095597|Drug|Oestraclin|Patients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days).
16408061|NCT05095597|Procedure|Umbilical cord blood collection|The SCU will be collected using a blood collection bag containing anticoagulant. This step will be performed by the medical and nursing staff of the obstetrics service of the HUP La Fe. The blood collection bags will be the following, or similar: Cord Blood Collection Bags from MACOPHARMA; CPD Umbilical Cord Bag from GRIFOLS.
16408062|NCT05095597|Procedure|Endometrial biopsy|Biopsies will be taken by specialized medical personnel by aspiration with an intrauterine cannula (pipelle or cornier). Samples will be collected in 15 mL tubes (or in a larger capacity container if needed) containing PBS or RNA later until frozen at -80ºC, at the IVI Foundation facilities. Prior to freezing (in a 1.8-2 mL cryotube) the PBS will be removed and the sample cleaned in a Petri dish if needed.
16408064|NCT05095571|Dietary Supplement|EH301 (Nicotinamide Riboside/Pterostilbene)|For this study EH301 is defined as Investigational Product(s) (IP). The ALS extension study is an open label study with active treatment of all patients thet have passed through the NO-ALS trial.
16408065|NCT05095558|Biological|microtransplantation, HLA-mismatched donor peripheral stem cell infusion|infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
16408066|NCT05095545|Drug|AV5080|Hard gelatin capsules with a white body
16408067|NCT05095545|Other|Placebo|Hard gelatin capsules with a white body
16408068|NCT05095532|Biological|Bone marrow-derived mesenchymal stem cells|MSC transplantation
16408069|NCT05095532|Other|Placebo|Standard of Care
16408070|NCT05095519|Drug|18F-DCFPyL|18F-DCFPyL will be administered with a single dose of 3.5 MBq per kg (2-4 MBq per kg), maximum 400 MBq), administered as a slow (over 30 seconds) intravenous injection
16408071|NCT05095506|Other|eHealth Intervention|The intervention platform is interactive, and uses multimedia-assisted components. The system uses three SCI-QOL computer-adaptive tests (CATs) to assess depression, anxiety, and resilience; cut scores are used to tailor multi-media content that specifically addresses users' emotional health concerns.
16408072|NCT05095506|Other|Active Control Condition|The active control condition is a static site that displays symptom assessments followed by one educational video each week. These videos, which play in a predetermined order, provide education about managing physical health in individuals with SCI.
16408073|NCT05095493|Dietary Supplement|Zinc Acetate|50 mg tablet
16408074|NCT05095493|Dietary Supplement|Placebo|Zinc Acetate matched placebo tablet
16408075|NCT05095480|Drug|Red Yeast Rice Pill|Taking Lesstat
16408076|NCT05095480|Drug|Placebo|Placebo receiving group
16408077|NCT05095467|Procedure|HIPEC|The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
16408078|NCT05095467|Drug|Paclitaxel-albumin|albumin paclitaxel D1, D8; S-1: D1-D14
16408079|NCT05095467|Drug|Tegafur-gimeracil-oteracil potassium|40mg bid(BSA<1.5 m2) ，60mg bid(BSA>=1.5 m2); D1-D14, po, bid.
16408080|NCT05095467|Procedure|Surgery+HIPEC|gastrectomy with D2 lymphadenectomy+HIPEC procedure
16408081|NCT05095454|Device|Percutaneous epidural electrical spinal stimulation|"Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
~Ripple Neuromed Nomad Neurostimulation System"
16408082|NCT05095454|Device|Transcutaneous electrical spinal stimulation|Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
16408083|NCT05095441|Biological|C5252|A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.
16408084|NCT05095428|Behavioral|PARTS Program|The PARTS Program is a 16-week group intervention model of Internal Family Systems (IFS), with 8 individual IFS clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.
16408085|NCT05095428|Behavioral|NBSR-T Program|The NBSR-T Program is a 16-week nature-based group intervention model, with 8 individual non-IFS clinical sessions on a biweekly basis, developed as an attention placebo control for individuals diagnosed with PTSD.
16408086|NCT05095415|Other|Occupational Therapy Pre-operative Consult|Preoperative education will be given by the treating orthopedic surgeon first and will then be followed by a consult with a final semester, occupational therapy student. The pre-operative education will include the importance of attending therapy, what to expect at therapy, typical duration of therapy for their specific diagnosis, and address any questions of ther participant. Participants will be given educational materials and access to education videos to watch if they so choose.
16408087|NCT05095415|Other|Typical Pre-Operative Education|Participants will receive all preoperative education from their orthopedic surgeon and will not be spoken to directly about the therapeutic process until their first scheduled therapy appointment.
16408088|NCT05095376|Drug|Lomustine|Given PO
16408089|NCT05095376|Radiation|Photon Beam Radiation Therapy|Undergo radiation therapy
16408090|NCT05095376|Other|Quality-of-Life Assessment|Ancillary studies
16408091|NCT05095376|Other|Questionnaire Administration|Ancillary studies
16408092|NCT05095376|Drug|Temozolomide|Given PO
16408093|NCT05095363|Behavioral|PCplanner|A mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants.
16408094|NCT05095350|Biological|Probiotic powder|Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.
16408095|NCT05095350|Biological|Placebo powder|Placebo powder containing maltodextrin and no probiotics.
16408096|NCT05095337|Drug|[14C]SHR1459|Patients will receive single dose of orally [14C]SHR1459 on Day 1.
16408097|NCT05095311|Drug|Nedocromil Sodium|Eight participants will be administered 4 mg of nedocromil sodium to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
16408098|NCT05095311|Drug|Cetirizine HCl|Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
16408099|NCT05095311|Other|Placebo|The placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline.
16408100|NCT05095298|Drug|Vaccine, COVID19|Multi-center randomized controlled clinical trial, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, or recombinant subunit protein vaccine and mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
16408173|NCT05085392|Behavioral|Trauma-Informed Yoga|6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
16408174|NCT05085314|Procedure|Ngenuity digital 3D microscope|Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX
16408175|NCT05085314|Procedure|Conventional microscope|Cataract surgery under topical anesthesia with a conventional microscope
16408101|NCT05095285|Other|Swaddling|"Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.
~Common procedure steps:
~Legal representatives of the infants will sign an informed consent form.
~İncubator cover and nesting
~Endotracheal suction(ES) was performed in the supine position.
~ES was done at the time of care the baby needed.
~No painful procedure was applied until 2 hours before ES and 15 minutes after ES.
~Aspiration was performed sterile at 80 mmHg pressure.
~A second nurse assisted in the suction process and the procedure took no more than 15 seconds.
~The amount of oxygen taken by the baby was increased by 10% 30 seconds before the suction procedure and returned to its original value 60 seconds after the procedure.
~Beginning 3 minutes before the ES procedure, during the procedure and until 15 minutes after the procedure, the infants' behaviors and bedside monitor indicators were video recorded."
16408102|NCT05095285|Other|Oropharyngeal colostrum|"Common procedure steps
~In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue."
16408104|NCT05095259|Drug|insulin human|Hyperinsulinemic glucose clamp studies require that insulin is administered at a steady continuous rate to achieve stable levels of hyperinsulinemia. To reach this, insulin needs to be infused intravenously using a standard intravenous pump system. The insulin dose will be adjusted according to the body surface area, aiming for insulin levels of ~170 mU/l, which is within the physiological range. Thus, for a subject with a bodyweight of 70 kg, body length of 180 cm and - consequently - a body surface area of 1.936 m2, the required insulin infusion can be calculated as: 1.936 x 60 x 60 ÷ 1000 = 7.0 units per hour
16408105|NCT05095259|Drug|Epinephrin|Epinephrine are prepared in 100 ml isotone saline solution according to weight and infused in 3 different infusion rates: 10 ng∙kg-1∙min-1, 25 ng∙kg-1∙min-1 and 50 ng∙kg-1∙min-1, for 20 minutes each. After each adrenaline infusion, substrate response will be measured by blood samples of glucose, lactate, free fatty acids, alanine, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such as pulse and blood pressure are monitored as well.
16408106|NCT05095259|Procedure|Muscle biopsy|With the study subject resting in the supine position, the skin is disinfected on the lateral side of the thigh around 15 cm above the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the muscle with a very thin needle. When the anaesthetic effect has set in after a couple of minutes an insertion is made in the skin and the subcutaneous tissue through which the biopsy cannula is inserted into the muscle. A small piece (around 150 mg) of the muscle is collected, which may be experienced as somewhat unpleasant, but will last for a very short while ( ~1-2 seconds). The needle is removed, a sterile Band-Aid is applied, and the study subject can leave the site after termination of the trial. The biopsy may cause some muscular tenderness for 2-3 days corresponding to minor muscular trauma.
16408107|NCT05095259|Procedure|Adipose tissue biopsy|With the study subject resting in the supine position, the skin is disinfected on one side of the abdomen around 5-10 cm lateral from the umbilicus to the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the adipose tissue with a very thin needle. When the anaesthetic effect has set in after a couple of minutes an insertion is made in the skin and the subcutaneous tissue through which the biopsy cannula is inserted into the adipose tissue. A small piece (around 1 gram) of the adipose tissue is collected, which may be experienced as somewhat unpleasant, but will last for a very short while ( ~1-2 seconds). The needle is removed, a sterile Band-Aid is applied, and the study subject can leave the site after termination of the trial. The biopsy may cause some tenderness for 2-3 days corresponding to minor trauma.
16408108|NCT05095259|Drug|Glucagon|Glucagon is prepared in doses of 10 µg, 25 µg, and 50 µg and intravenously injected with intervals of 2 hours. After each glucagon injection, blood samples will be drawn to measure plasma glucose, glucagon, lactate, free fatty acids, alanine, amino-acids, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such as pulse and blood pressure are monitored as well.
16408109|NCT05095259|Device|IPRO 2 Medtronic Minimed|All potential subjects will receive a blinded continuous glucose sensor at Visit 1. At the following visits, the CGM will be reviewed for hypoglycaemia episodes and replaced at the same time. At Visit 2 a final screening of the inclusion criteria will take place, which involves the CGM data of the first week. A blinded CGM will be installed a week before every visit.
16408110|NCT05095259|Procedure|7T Magnetic Resonance Imaging|Subjects will undergo a hyperinsulinemic euglycaemic glucose clamp, as mentioned above, in the MRI scanning room. After 30 minutes of stable normoglycaemia, subjects are taken into the MRI scanner (Philips Achieva 7.0 T) where brain, liver, thigh and calf muscle are scanned. After every anatomically different area, the subjects must be taken out of the scanner, while scanning coils are replaced. All subjects are advised to lie still and press the alarm button if necessary.
16408111|NCT05095259|Procedure|Indirect Caliometry using Jaeger Oxycon Champion|Resting metabolic rate will be estimated, after reaching stable plasma glucose level, via a hyperinsulinemic euglycaemic clamp, as mentioned above. This will be done by indirect calorimetry, using a ventilated hood system (Jaeger Oxycon Champion, software version 4.3, Jaeger, Mijnhardt). Subjects are instructed to lie down and rest for a period of 30 minutes. Subjects are also instructed not to move, talk or sleep unless necessary during the period of measurement. The recorded measurement after 5 minutes to 30 minutes will be used for analysis.
16408112|NCT05095259|Procedure|Core temperature and thermography using Thermovision SC645|Thermography (Thermovision SC645, FLIR Systems, Wilsonville, OR, USA) is used to determine cutaneous vascular perfusion. Data is analogue-digital converted and sampled at 100 Hz (Powerlab, ADInstruments, Colorado Springs, CO, USA).
16408113|NCT05095246|Biological|KB407 (Nebulization)|Nebulized solution of KB407, a replication-incompetent HSV-1 expressing full length human CFTR
16408114|NCT05095246|Biological|KB407 (Intradermal)|Intradermal injection of KB407, a replication-incompetent HSV-1 expressing full length human CFTR (Cohort 1 only)
16408785|NCT04586231|Drug|Lenvatinib|Capsule available in 4 mg and 10 mg dosages
16408115|NCT05095233|Behavioral|Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP)|"YA-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behavior Therapy (CBT), including 8-10 sessions delivered over three months.
~This intervention includes evaluation of the suicide risk, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking, relapse prevention strategies, training on interoceptive awareness, mood management and behavior."
16408116|NCT05095233|Device|CBT based Conversational Agent (Woebot) for Therapeutic Use|Woebot, an artificially intelligent chatbot and recently launched app that uses the principles of cognitive-behavioral therapy, or CBT-one of the most heavily researched clinical approaches to treating mental health problems.
16408117|NCT05095207|Drug|Abemaciclib|100 mg orally twice daily, day 1 to 28. If no toxicity in cycle 1 for the first 3 patients, increase dose to 150mg orally twice daily day 1-28 and enroll 3 patients. If excessive toxicity experienced at 100mg orally twice daily dose, decrease dose to 50mg orally twice daily day 1-28.
16408118|NCT05095207|Drug|Bicalutamide|150 mg orally daily, day 1 to 28.
16408119|NCT05095194|Procedure|Cataract surgery with IOL implantation and with/without capsular tension ring implatation|Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation
16408120|NCT05095181|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16408121|NCT05095168|Drug|CAN106|CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.
16408122|NCT05095168|Drug|Placebo|placebo
16408123|NCT05095155|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16408124|NCT05095142|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16408125|NCT05095129|Genetic|SNP analysis of the DNA|SNP analysis of the DNA obtained from peripheral blood sample
16408126|NCT05095116|Drug|APT-1011 3 mg HS|APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
16408127|NCT05095077|Drug|Tadalafil 40 MG|Single dose on study day 1/2
16408128|NCT05095077|Drug|Placebo|Identical to active IMP
16408129|NCT05095064|Drug|Onivyde® + 5-FULV|Nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV)
16408130|NCT05095051|Device|Paxman Cryocompression System (PCCS)|"Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression.
~The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes."
16408131|NCT05095051|Device|Paxman Cryocompression System (PCCS)|"The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles.
~Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours."
16408132|NCT05095038|Dietary Supplement|Appethyl®|Spinach extract, capsules, 5g/day, 26 weeks.
16408133|NCT05095038|Dietary Supplement|Placebo|Pea protein, capsules, 5g/day, 26 weeks.
16408134|NCT05095025|Drug|Bupivacaine Hydrochloride 20ml injectate|Sequential dosing, starting at 50mg with 5mg increments based on the outcome of the preceding participant
16408135|NCT05095012|Other|Pediatric Acute Care Concussion Clinical Pathway|MD assessment will be partially standardized to assess for patients at higher risk of becoming persistently symptomatic. These patients scoring as 'high risk' will be referred to one of three specialty clinics. High risk is defined as scoring 9 or higher out of 12 on the 5P score.
16408136|NCT05094999|Device|Proprioceptive stimulations|Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the intervention group will receive proprioceptive stimulations set to create illusions of movement.
16408137|NCT05094999|Device|Sham stimulations|Vibration treatment will last eight weeks for each patient, with 4 sessions per week, 30 minutes per session. Subjects of the control group will receive sham stimulations.
16408138|NCT05093179|Procedure|Deep tissue massage|Administered as a soft tissue mobilization performed by the therapist with fingertips, knuckles, elbows and/or fists on the tissues that manifest symptoms of fascial restrictions. The techniques were performed with individually adjusted force until the change (eg. increased mobility) in the tissue being treated was stated by the therapist.
16408139|NCT05093179|Procedure|Classic massage|The subject was lying supine on the table, with a roller placed under the knee joints, the upper limbs along the body. The following sequence of techniques was used in the longitudinal and transverse strands and in the intercostal spaces (excluding the breast in women): effleurage, friction, petrissage, pressures, tapotement and vibrations.
16408142|NCT05091619|Biological|Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed|Intramuscular injection
16408143|NCT05091619|Biological|Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed|Intramuscular injection
16408144|NCT05091619|Biological|Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine|Intramuscular injection
16408145|NCT05091307|Biological|Ad26.COV2.S|Ad26.COV2.S will be administered as an IM injection.
16408146|NCT05091307|Other|Placebo|Placebo will be administered as an IM injection.
16408147|NCT05091307|Biological|Influenza Vaccine|Influenza vaccine high and standard dose will be administered as IM injection.
16408148|NCT05091073|Drug|NNC0385-0434|All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
16408149|NCT05087992|Drug|BI 905711|BI 905711
16408150|NCT05087992|Drug|FOLFIRI|FOLFIRI
16408151|NCT05087992|Drug|Bevacizumab|Bevacizumab
16408152|NCT05087446|Behavioral|Early assessment team|Early assessment team (EAT):The patients receive their first assessment by an early clarification team within a few weeks after the team receiving the referral. The team then decides whether further assessment and/or treatment should be given in the general outpatient clinic, and/or whether any other follow-up may be appropriate. In the first meeting the patient preferably meets two therapists, who conduct a semi-structured interview with focus on health and level of functioning. If considered appropriate, the team may offer a short-term intervention.
16408153|NCT05087446|Behavioral|Admission to General psychiatric outpatient clinic|Ordinary procedures for admission to an outpatient clinic are followed in accordance with the Norwegian Directorate of Health's national prioritization guide. Referrals are assessed on the basis of severity and placed on a regular waiting list (usually a waiting period of 1-3 months). The patients receive their first personal assessment from a therapist in a general outpatient clinic who takes a position on what is to be initiated and, if necessary, offers further assessment / treatment in accordance with procedures in the outpatient clinics. This is not standardized beyond current practice.
16408154|NCT05087290|Other|Cases|"All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires
~Optional:
~Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor"
16408155|NCT05087290|Other|Controls|"All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires
~Optional:
~Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor"
16408156|NCT05086796|Behavioral|Substance Use Treatment and Recovery Team (START)|"START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid use disorder and to increase linkage to aftercare.
~The components of the START intervention are as follows:
~Triage
~Engage, Assess, and Plan
~Treat
~Communicate and Coordinate
~Follow up
~Monitor"
16408157|NCT05086770|Device|Spherical Gelfoam (Nexsphere™)|Spherical Gelfoam (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for spherical gel foam are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
16408158|NCT05086770|Device|Embosphere|Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
16408159|NCT05086692|Drug|MDNA11 Monotherapy|"MDNA11 will be administered by the IV route on a once every 2 weeks (Q2W) dosing schedule.
~Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the Recommended Phase 2 Dose (RP2D)"
16408160|NCT05086692|Drug|MDNA11 in combination with checkpoint inhibitor|MDNA11 in combination with checkpoint inhibitor Combination cohort is planned to evaluate the safety/ tolerability and anti-tumor activity of single agent MDNA11, or in combination with CPI in patients with solid tumors
16408161|NCT05086250|Drug|Ketamine|Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
16408162|NCT05086250|Drug|Placebo|Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
16408163|NCT05086250|Drug|Placebo|Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
16408164|NCT05086250|Drug|Ketamine|Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
16408165|NCT05086159|Behavioral|Pain Neuroscience Education|"Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks.
~Session 1: the nervous system is like an alarm to protect.
~Session 2: common ways the nervous system becomes sensitive.
~Session 3: importance of gradual conditioning and neuroplasticity.
~Session 4: common ways to decrease nervous system sensitivity."
16408166|NCT05086159|Behavioral|Exercise|"The exercise protocol for each group will be identical and modeled after the Back to Fitness program. This program will consist of a 5-10-minute cardiovascular warm-up of walking in place or riding an exercise bike. Next is a 15-minute circuit consisting of 10 different general exercises for 1-minute each. Finally, a 5-minute cool down will consist of light stretching and trunk range of motion exercises. Each exercise will be tailored as easy, medium, or hard depending on the individual patient's tolerance. This program has been shown to be equally as effective as motor control exercises for long-term outcomes in patients with non-specific LBP."
16408167|NCT05086159|Behavioral|Traditional Education|"Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks.
~Session 1 will include a basic overview of the anatomy of the spine.
~Session 2 will discuss an overview of stress symptoms to include hypervigilance, avoidance, and re-experiencing.
~Session 3 will cover common recommendations delivered in stress education: the do's and don'ts of stress management.
~Session 4: review and mindfulness."
16408168|NCT05086120|Other|eCARIBOU|A 16 week remote electronically deliver Integrated Care Pathway (ICP) for adolescents (13-18 years old) with Major Depressive Disorder (MDD).
16408169|NCT05085873|Drug|Sodium Oxybate injection|"Induction dosage : 60 mg/kg by direct intravenous injection.
~Continuous dosage : 45 mg/kg/h by continuous intravenous injection.
~Additional dosage if the Richmond Agitation Sedation Scale (RASS) score exceeds -4 : 1000 mg sodium oxybate by direct intravenous injection bolus every hour at most until RASS score reaches -4.
~Sedation maintained until patient death."
16408170|NCT05085873|Drug|Midazolam injection|"Induction dosage : 1 mg every 3 min by direct intravenous injection until RASS score reaches -4 (with a maximum of 30 min).
~Continuous dosage : Half of titration dosage every hour by continuous intravenous injection.
~Additional dosage if the RASS score exceeds -4 : 1 mg every 3 min by direct intravenous injection (without exceeding 10 mg/h).
~Sedation maintained until patient death."
16408171|NCT05085535|Other|Manual Therapy|Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy
16408176|NCT05085288|Device|Intermittent electrical stimulation system (IES) treatment and turning patient every two hours|The investigators propose to assess whether addition of the IES system and the use of the standard of care procedure of turning the patient every two hours reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 or stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population.
16408177|NCT05085288|Other|Turning population every two hours|The investigators propose to assess whether standard of care of turning the patient every two hours reduces the morbidity of sacral and ischial pressure injuries.
16408178|NCT05085223|Other|Daily urine collection for biochemical analysis|For every patient in ICU, a daily morning urine sample will be collected from the already collected urine via catheter.
16408179|NCT05085223|Other|Subanalysis for comparison of 24hour urine collection versus spot-check measurements|For a subgroup of 30 sedated patients, 24 hour urine collection will be collected. In addition, every 2 hours a 10ml urine sample will be collected.
16408180|NCT05084833|Behavioral|Control|Electronic educational materials
16408181|NCT05084833|Behavioral|Patient activation|Interactive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants
16408182|NCT05084833|Behavioral|Primary care provider activation|Faxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers
16408183|NCT05084534|Drug|Midodrine|"Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day)
~• Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age)"
16408184|NCT05084534|Other|Standard medical treatment|"Standard Medical Treatment will be continued in all, which includes,
~To continue restriction of sodium to < 2meq/kg/day
~To continue maximum tolerable dose of diuretics
~Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
~Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day)"
16408185|NCT05084248|Drug|Ergocalciferol Capsules|Capsules of ergocalciferol at 400 IU and 4000 IU
16408186|NCT05084027|Combination Product|venetoclax combining with fludarabine and melphalan|Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2
16408187|NCT05083988|Device|virtual reality glasses|a system composed of a head-mounted wide view display placed in front of the eyes and headphones placed in ears, it has the ability to block the real-world stimuli. This could distract the patient from the dental environment, which helps reduce anxiety
16408188|NCT05083988|Device|music|Music can be used to distract patients from the anxiety provoking stimulus. It helps the patient to escape from the stressful reality as it activates imaginary. Psychosocially music can offer peace and comfort to patients during dental treatment as it helps in making the environment less threatening.
16408189|NCT05083832|Procedure|Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block|Two different catheter techniques with same doses local anesthetic infusion
16408190|NCT05083663|Drug|Hyaluronidase|using hyaluronidase as an additive to bupivacaine
16408191|NCT05083598|Other|6 Minute walking test|The patient is asked to repetitively walk along a 15 m track, at their best speed, in six minutes. Before and after the exercise, blood arterial pressure and dyspnea level (via Borg scale) are assessed. Cardiac frequency and peripheral Oxygen saturation are assessed before the test, and every minute and in the two minutes following the exercise.
16408192|NCT05083598|Other|Frailty questionaires|Clinical Frailty Score, Metabolic Equivalent of Task, DUKE Activity Status Index
16408193|NCT05083390|Drug|norUrsodeoxycholic acid|500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
16408194|NCT05083312|Drug|APT-1011|APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
16408195|NCT05083312|Drug|Placebo oral tablet|Placebo orally disintegrating tablet
16408196|NCT05083286|Drug|OnabotulinumtoxinA|Injection of glabellar rhytids
16408197|NCT05082415|Drug|Brolucizumab|Participants received brolucizumab injection during the index period
16408198|NCT05082259|Drug|ASTX660|ASTX660 will be supplied as capsules. Each hydroxylpropyl methylcellulose (HPMC) capsule contains either 30 mg or 90 mg of ASTX600 free-base equivalents, suitable for oral administration. Bottles are labelled with the capsule strength (ie, 30 mg or 90 mg) and are further distinguished by different-colored labels. Each bottle contains 14 capsules and an oxygen-absorber (not to be consumed).
16408199|NCT05082259|Drug|Pembrolizumab|"Pembrolizumab Solution for Infusion 100 mg/vial is a liquid drug product supplied as a clear to opalescent solution, essentially free of visible particles, in Type I glass vials and manufactured using the fully formulated drug substance with L-histidine as buffering agent, polysorbate 80 as surfactant, and sucrose as stabilizer/tonicity modifier.
~Pembrolizumab Solution for Infusion can be further diluted with normal saline or 5% dextrose in the concentration range of 1 to 10 mg/mL in IV containers made of polyvinyl chloride (PVC) or non-PVC material."
16408200|NCT05082116|Drug|turoctocog alfa pegol (N8-GP)|N8-GP will be injected into a vein (intravenous injections) every 4 days in at least 28 weeks
16408201|NCT05081622|Behavioral|Interaction Competencies with Children - for Teachers (ICC-T)|Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting
16408202|NCT05079919|Drug|ISIS 678354|ISIS 678354 will be administered by SC injection.
16408203|NCT05079919|Drug|Placebo|ISIS 678354-matching placebo will be administered by SC injection.
16408204|NCT05079451|Drug|3BNC117-LS|3BNC117-LS will be administered by intravenous infusion (directly into the participants vein) over a period of 30 to 60 minutes. The total time needed to administer the study drug may be longer, based on factors such as participant tolerance. The participant's dose will be calculated using their most current weight on record.
16408229|NCT05073003|Drug|altSonflex Placebo|2 doses of altSonflex Placebo, administered intramuscularly, in the non-dominant arm, either at Day 1 and Day 85 or at Day 1 and Day 169 (depending on the vaccination schedule) to adults in the ST1_Adults_Placebo_GR1 and ST1_Adults_Placebo_GR2 groups in Stage 1 (Europe).
16408205|NCT05079451|Drug|10-1074-LS|10-1074-LS will be administered by intravenous infusion (directly into the participants vein) over a period of 30 to 60 minutes. The total time needed to administer the study drug may be longer, based on factors such as participant tolerance. The participant's dose will be calculated using their most current weight on record.
16408206|NCT05079295|Procedure|CSDH evacuation|Burr hole for chronic subdural hematomas
16408207|NCT05079074|Drug|Druggable ctDNA alteration-guided therapy|Case group
16408208|NCT05079074|Drug|Physician chosen treatment|Control group
16408209|NCT05078957|Other|Stool sampling|Stool samples will be collected from participants at baseline and annually during 5 years
16408210|NCT05078957|Other|Frailty phenotype|According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.
16408211|NCT05078957|Other|Blood plasma collection|Blood plasma collection to measure persistent inflammation and immune activation
16408213|NCT05077956|Diagnostic Test|Cerebrospinal and Blood Serum Semaphorin 4A Levels|Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.
16408214|NCT05077917|Drug|Cromolyn Sodium|Nebulized treatment for 4 days followed by intranasal treatment starting on day 5.
16408215|NCT05077917|Other|Placebo|Nebulized treatment for 4 days followed by intranasal treatment starting on day 5.
16408216|NCT05076409|Drug|BI 425809|Period 1 and period 2
16408217|NCT05076409|Drug|fluconazole|Period 2
16408218|NCT05075213|Behavioral|contingency management (deposit contract)|Participants will deposit $30 of their own money to play QuitBet. Participants will submit a CO test once per day between the hours of noon and midnight. Participants whose CO test is 6ppm or lower (indicating no smoking) on at least 25 of 26 days between day 3-28 of the game will be declared winners and split the pot of deposited money. Participants who submit at least 21 CO tests, regardless of the result, will be entered into a raffle to win a prize worth $75.
16408219|NCT05075213|Behavioral|leaderboard and social feed|Participants will have access to a discussion board on which participants can post and respond to messages to each other. Also, a game host will post educational information about smoking cessation and serve as a discussion moderator.
16408220|NCT05075213|Behavioral|smoking cessation resource list|Participants will have access to a list of smoking cessation resources
16408221|NCT05074745|Diagnostic Test|ELISA POCT vs RT-PCR|3 swabs taken, buccal for RT-PCR and ELISA POCT, nasopharyngeal for RT-PCR
16408222|NCT05073354|Device|Full SWOT Model|Bundle of care that includes devices such as X Series monitor/defibrillator, AutoPusle automated compression device, Z Vent ventilator, and IPR therapies as well as bedside monitoring and diagnostics and training on a standardized care process.
16408223|NCT05073354|Device|Partial SWOT Model|Historical control. Partial bundle of care that includes some bedside monitoring and diagnostics as well as training on a standardize care process
16408224|NCT05073354|Other|Standard of Care|Standard of Care treatment to patients before development of SWOT protocol.
16408225|NCT05073224|Diagnostic Test|Active Straight Leg Raise Test|The ASLR test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb.
16408226|NCT05073224|Other|Active Straight Leg Raise Fatigue Task|The protocol is similar to the ASLR test, except that the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff will be placed under the participant's lumbopelvic region to assess movement of the spine/pelvis. The cuff will be inflated to 40 mm Hg, and the participant instructed to keep the needle as close to 40 mm Hg as possible throughout the test; no information will be provided on how to affect cuff pressure, but visual feedback of cuff pressure will be provided throughout the task. Ratings of perceived exertion (RPE) and pain will be obtained from participants every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested, but in different sessions. The order of limb testing (dominant vs non-dominant) will be randomized and counter-balanced. Limb dominance will be self-reported.
16408227|NCT05073224|Other|Lower Extremity Strength Testing|"A straight leg raise maximal voluntary contraction (MVC) of each lower extremity an MVC of the hip extensors of the grounded limb will be performed in supine before and within 2 minutes of completing the ASLR fatigue task. The straight leg raise MVC will be performed with a custom-made load cell instrumented strength testing device, which consists of a rigid platform on which the participant will lie. At the foot of the device is a tower that houses 2 load cells connected to a lightly padded push plate.
~The hip extension MVC will be performed on a force plate. Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed for each muscle group, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per muscle group will be performed following the ASLR Fatigue Task."
16408228|NCT05073224|Diagnostic Test|Ultrasound imaging of abdominal wall|Real time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise. The Principle Investigator has training and experience in musculoskeletal ultrasound.
16408230|NCT05073003|Biological|altSonflex1-2-3 Dose C|2 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to adults in the ST1_Adults_Dose C_GR1 and ST2_Adults_Dose C groups in Stage 1 and 2 (Europe and Africa) and children in the ST2_Children_Dose C group in Stage 2 (Africa), and at Day 1 and Day 169 to adults in the ST1_Adults_Dose C_GR2 group in Stage 1 (Europe); 3 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2_Infants_Dose C_Safety and ST2_Infants_Dose C_Dose find groups in Stage 2 (Africa).
16408231|NCT05073003|Biological|altSonflex1-2-3 Dose B|2 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to children in the ST2_Children_Dose B group in Stage 2 (Africa); 3 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2_Infants_Dose B_Safety and ST2_Infants_Dose B_Dose find groups in Stage 2 (Africa).
16408232|NCT05073003|Biological|altSonflex1-2-3 Dose A|3 doses of altSonflex1-2-3 Dose A administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2_Infants_Dose A_Safety and ST2_Infants_Dose A_Dose find groups in Stage 2 (Africa).
16408233|NCT05073003|Biological|GSK's Meningococcal A, C, Y and W-135 conjugate vaccine|1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 to adults in the ST2_Adults_Control C group and children in the ST2_Children_Control B and ST2_Children_Control C groups in Stage 2 (Africa); 2 doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to infants in the ST2_Infants_Control A_Safety, ST2_Infants_Control B_Safety, ST2_Infants_Control C_Safety and ST2_Infants_Control_Dose find groups in Stage 2 (Africa).
16408234|NCT05073003|Combination Product|GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine|1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly, in the non-dominant arm, at Day 85 to adults in the ST2_Adults_Control C group in Stage 2 (Africa).
16408235|NCT05073003|Combination Product|GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine|1 dose of GSK's Poliomyelitis, diphtheria, tetanus and pertussis vaccine administered intramuscularly, in the non-dominant arm, at Day 253 to infants in the ST2_Infants_Control A_Safety, ST2_Infants_Control B_Safety, ST2_Infants_Control C_Safety and ST2_Infants_Control_Dose find groups in Stage 2 (Africa).
16408236|NCT05073003|Combination Product|Sanofi Pasteur's Typhoid Vi polysaccharide vaccine|1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, in the non-dominant arm, at Day 85 to children in the ST2_Children_Control B and ST2_Children_Control C groups in Stage 2 (Africa).
16408237|NCT05073003|Biological|Serum Institute of India's Measles and rubella vaccine|2 doses of Serum Institute of India's Measles and rubella vaccine administered subcutaneously, in the non-dominant arm, at Day 29 and Day 281 to infants in the safety groups, and at Day 1 and Day 253 to infants in the dose-finding groups, in Stage 2 (Africa).
16408238|NCT05070767|Device|Neurolens spectacle lens|spectacle lens
16408239|NCT05070767|Device|Placebo spectacle lens|spectacle lens for refractive error correction
16408240|NCT05069974|Drug|Linezolid|After randomized to the experimental arm, the patient will take 1 tablet of Linezolid every 24hours during 5 days.
16408241|NCT05069974|Drug|Benzathine Penicilllin G|After randomized to the control arm, the patient will receive a single dose of intramuscular BPG.
16408242|NCT05069844|Dietary Supplement|Gum chewing for 2 minutes|In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.
16408243|NCT05069844|Dietary Supplement|Gum chewing for 4 minutes|In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.
16408244|NCT05069389|Other|Data collection|"Some data will be collected for all patients included :
~specific treatment administered in COVID unit
~dosages of treatment
~inclusion in clinical trials
~Evolution of French recommendations and the publication of scientific articles"
16408245|NCT05065372|Drug|Metformin Hcl 1000Mg Tab|Agent used to modify insulin sensitivity
16408246|NCT05065372|Drug|Aminohippurate Sodium 20 % Injection|Diagnostic aid/agent used to measure renal plasma flow and calculate renal vascular resistance
16408247|NCT05065372|Drug|Iohexol 300 Mg/mL Injectable Solution|Diagnostic aid/agent used to measure glomerular filtration rate
16408248|NCT05065372|Drug|Placebo|Identical to Metformin Hcl 1000Mg Tab but without metabolic effects
16408249|NCT05064371|Drug|Eptinezumab|Concentrate for solution for IV infusion
16408251|NCT05062057|Device|Adhesive ambulatory ECG recording patches|All women in both groups will undergo sequential placement of two 14-day adhesive ambulatory ECG recording patches for a total of 28 days of ECG recording
16408252|NCT05062031|Device|Defocus Incorporated Multiple Segments® (DIMS®) lenses|Daily wear for 24 months. Lenses have a central monofocal optical zone correcting spherical or spherocylindrical ametropia, surrounded by a ring made up of 300 defocusing pellets. This lens geometry reduces the phenomenon of blurred image projected in the retinal periphery, encountered when myopic eyes are corrected with monofocal lenses.
16408253|NCT05062031|Drug|Atropine 0.05% eyedrops|One drop each evening in both eyes for 24 months.
16408254|NCT05062031|Device|Monofocal lenses|Daily wear for 24 months
16408255|NCT05061810|Behavioral|Smartphone application self-management programme|The intervention in this trial is a self-management programme via a smartphone app. This self-management programme measures lung function (FEV1), oxygen saturation (SP02), dyspnoea score (m MRC) and step count. It also provides educational videos such as recognising symptoms of an exacerbation and physical activity. The smartphone app self-management programme will provide real time data monitoring resulting in baseline trends in patient's disease pattern. Additionally, it also provides subjective data that will allow the clinician to develop an understanding of the patient's quality of life.
16408256|NCT05061693|Drug|INCB054707|Oral; Tablet
16408257|NCT05061693|Drug|Placebo|Oral; Tablet
16408258|NCT05061420|Drug|Pembrolizumab (Keytruda®)|Pharmaceutical Form: Concentration for solution for infusion Route of Administration: Intravenous Infusion
16408259|NCT05061420|Drug|SAR444245 (Thor-707)|Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion
16408877|NCT04516967|Drug|Placebo|Placebo comparator tablet
16408260|NCT05061420|Drug|Cetuximab (Erbitux®)|Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous Infusion
16408261|NCT05059236|Drug|Darolutamide (BAY1841788, Nubeqa)|300 mg per tablet, oral administration with food
16408262|NCT05059236|Other|ADT|LHRH agonist/antagonist or orchiectomy
16408263|NCT05058872|Drug|Levonorgestrel/ethinyl estradiol|Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
16408264|NCT05058872|Drug|Placebo|Placebo comparator
16408265|NCT05057481|Drug|Mycophenolate Mofetil 500mg|MMF 2gram/day orally for 12 weeks
16408266|NCT05057481|Drug|Rituximab|375 mg/m2 of rituximab given intravenously weekly for 4 weeks.
16408267|NCT05054309|Dietary Supplement|Bifidobacterium longum|A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
16408268|NCT05054153|Other|refined carbohydrate breakfast|After wearing CGM on Day 1, participants will be provided with breakfast A once daily on Day 2, Day 5 and Day 6. Breakfast A contains white bread (50g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
16408269|NCT05054153|Other|whole grain breakfast|After wearing CGM on Day 1, participants will be provided with Breakfast B once daily on Day 3, Day 4 and Day 7. Breakfast B contains plain oats (35g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
16408270|NCT05054153|Other|intermittent fasting|The period during Day 8 to Day 13 is intermittent fasting period. Participants will experience the moderate fasting on Day 9 and Day 12, which means their daily energy intake is expected to be controlled within 500-600 kcal limit. In these two days, participants will be provided with all three meals. Percentages of macronutrients of provided meals will follow the Recommended Dietary Health guidelines for Chinese residents. The oral glucose tolerance test (OGTT) will be conducted in the morning on Day 8 and Day 13, to test short-term impact of IF intervention on individuals' glucose tolerance. The breakfasts on Day 10 and Day 11 will be the same as that in fasting days. Other meals will be wash-out meals.
16408271|NCT05053867|Drug|tranexamic acid|Inhaled
16408272|NCT05053867|Other|Usual Care|Standard of Care
16408273|NCT05053139|Drug|NNC0365-3769 (Mim8)|Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.
16408276|NCT05050825|Other|Patient clinical management based on the CDSA strategy|The CDSA strategy is a combination of point of care tests (rapid diagnostic tests targeting malaria, dengue fever and streptococcus group a sore through) and a mHealth tool that provides patient management recommendations, including treatment, based on an algorithm integrating patient clinical signs and symptoms, history and diagnostic test results.
16408277|NCT05048875|Drug|JNJ-64281802 (sentinel high dose)|Group 1a, JNJ-64281802 (high dose: 600-mg loading dose/200-mg maintenance dose)
16408278|NCT05048875|Drug|JNJ-64281802 (remaining high dose)|Group 1b, JNJ-64281802 (high dose: 600-mg loading dose/200-mg maintenance dose)
16408279|NCT05048875|Drug|JNJ-64281802 (medium/low dose)|Group 2, JNJ-64281802 (low dose: 40-mg loading dose/10-mg maintenance dose) OR JNJ-64281802 (medium dose: 200-mg loading dose/50-mg maintenance dose)
16408280|NCT05048875|Drug|JNJ-64281802 (dosing regimen X)|"Group 3, JNJ-64281802 (dosing regimen X)
~Up to 3 dosing regimens can be selected for evaluation in Cohort 2 based on interim analysis data from Cohort 1. The number of participants in total and the number of participants on active and placebo per group will depend on the number of dosing regimens in Cohort 2."
16408281|NCT05048875|Drug|JNJ-64281802 (dosing regimen Y)|"Group 4, JNJ-64281802 (dosing regimen Y)
~Up to 3 dosing regimens can be selected for evaluation in Cohort 2 based on interim analysis data from Cohort 1. The number of participants in total and the number of participants on active and placebo per group will depend on the number of dosing regimens in Cohort 2."
16408282|NCT05048875|Drug|JNJ-64281802 (dosing regimen Z)|"Group 5, JNJ-64281802 (dosing regimen Z)
~Up to 3 dosing regimens can be selected for evaluation in Cohort 2 based on interim analysis data from Cohort 1. The number of participants in total and the number of participants on active and placebo per group will depend on the number of dosing regimens in Cohort 2."
16408283|NCT05048875|Drug|Placebo|No therapeutic effect, used as a control in testing new drugs
16408284|NCT05046873|Drug|Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL|Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
16408285|NCT05046873|Drug|semaglutide 1.34 mg/mL (placebo)|Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
16408286|NCT05046873|Drug|Semaglutide 1.34 mg/mL|The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
16408287|NCT05046873|Drug|NNC0480-0389 A 10 mg/mL|The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
16408288|NCT05044884|Other|Otago Exercise training|"Warm-up exercises. Chair March, Arm swings ( 30 second), Head movement, neck movement, back extension, trunk movement, ankle movement (repeat 5 times).
~Back of thigh stretch, calf stretch, (hold for 8 seconds).
~Strengthening exercises Front knee strengthening, back knee strengthening, side hip strengthening (2 or more sets of 10 reps) Calf raises, toe raises (repeat this exercises 10 to 20 times)
~Balance improvement exercises Knee bends, heel-toe standing, heel toes walking, one leg stand ( start with 5 sec move up to 10 sec) Side walk, heel walking, sit to stand, backwards walking, heel toes walking backwards, walking and turning around, stair walking (10 steps).
~Cool-down session Back of thigh stretch, calf stretches ( 10 to 20 sec hold, 1 to 3 reps)
~Pulmonary rehabilitation program
~Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
~Stretch exercise for major respiratory muscles."
16408289|NCT05044884|Other|Circuit training|"Functional strength exercises Heel raise, toe raise, walking on toes, step ups in all directions ( forward, backward and sideways) (2 sets and 8 reps)
~Stance exercises Tandem, narrow, one leg stance, and stand on uneven surfaces with open eyes (each exercise 30 seconds) Tandem, narrow, one leg stance, and stand on uneven surfaces with eyes closed (each exercise 15seconds).
~Transition exercises Sit to stand from chair with arms (10 reps) and then without arms support (5 reps).
~Sit on floor and stand up with assistance and then without assistance.
~Gait training Walking tandem, sideway and backward with arm support. Walking tandem, sideway and backward without arm support Walking tandem, sideway and backward over obstacles
~Pulmonary rehabilitation program
~Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
~Stretch exercise for major respiratory muscles"
16408290|NCT05044325|Drug|GSK3884464|GSK3884464 will be administered
16408291|NCT05044325|Drug|Placebo|Placebo to match GSK3884464 will be administered.
16408292|NCT05042583|Procedure|Stellate ganglion block|The probe direction was 30-45 degrees from the sagittal plane of the neck. The anterior nodules of the transverse process of the sixth cervical vertebra were displayed. The important anatomical structures were distinguished, and the internal carotid artery and longus cervical muscle were observed. A 25G, 6cm puncture needle was used with the tip beveled downward, and the needle path and tip were shown under ultrasound. The tip reached the high-echo sieve structure between the carotid artery and longus cervical muscle, and the drug solution was injected after withdrawal without blood and gas . The experimental group was injected with 6ml 0.5% ropivacaine.
16408293|NCT05039008|Other|Blood flow restriction|The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.
16408294|NCT05038020|Drug|AKST4290|Oral AKST4290
16408295|NCT05038020|Drug|Placebo|Oral Placebo
16408296|NCT05037630|Behavioral|Self-guided Digital Tool for Problematic Alcohol Use|See arm/group-description
16408307|NCT05035212|Biological|RSVpreF|RSV vaccine (RSVpreF)
16408308|NCT05035212|Biological|Placebo|Placebo
16408309|NCT05034159|Behavioral|Cognitive Behavioral Therapy for Insomnia|Same as is described previously.
16408310|NCT05033054|Dietary Supplement|EffCaMgCitrate 480 mg|Effervescent calcium magnesium citrate ( EffCaMgCitrate) is a powder mixture of calcium carbonate, trimagnesium dicitrate, and citric acid monohydrate, to be ingested orally after dissolving in water twice daily.
16408311|NCT05033054|Drug|Dapagliflozin 10 mg|Dapagliflozin tablets containing 10 mg will be administered orally with 8 oz water.
16408312|NCT05033054|Dietary Supplement|Placebo EffCaMgCitrate|Placebo Effervescent calcium magnesium citrate ( EffCaMgCitrate) (480mg) to be ingested orally after dissolving in water twice daily.
16408313|NCT05033054|Drug|Placebo Dapagliflozin|Placebo Dapagliflozin tablets (10 mg) will be administered orally with 8 oz water.
16408314|NCT05029882|Drug|ABBV-400|Intravenous (IV) Infusion
16408315|NCT05029466|Drug|Psilocybin|Participants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin.
16408329|NCT05026424|Other|Balance oral nutritional drink - control|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
16408330|NCT05026424|Other|Balance oral nutritional drink - test|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
16408331|NCT05026008|Drug|SR1375|The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water
16408332|NCT05026008|Drug|Matching placebo|The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water
16408333|NCT05025267|Other|Medical Food: Peptide-Based Enteral Formula|Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube
16408334|NCT05023707|Biological|anti-FLT3 CAR-T|Single intravenous infusion of anti-FLT3 CAR-T cells
16408335|NCT05023369|Drug|Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)|Dexamethasone will be administered as an injectable solution (4mg/ml). Every ml of this solution contains 4 mg of dexamethasone sodium phosphate, corresponding to 3 mg of dexamethasone. Thus 3 ml of solution will be injected peri-articularly (arm-A)
16408336|NCT05022342|Other|alpelisib plus fulvestrant|Prospective observational study. There is no treatment allocation. Patients administered alpelisib plus fulvestrant, that have started before inclusion of the patient into the study will be enrolled.
16408337|NCT05021835|Drug|Ziltivekimab|Administered subcutaneously (s.c., under skin) once-monthly and added to standard of care
16408338|NCT05021835|Drug|Placebo (ziltivekimab)|Administered subcutaneously (s.c., under skin) once-monthly and added to standard of care
16408339|NCT05019495|Behavioral|PrOMOTE|This is an opt-out, proactive approach to tobacco treatment by a clinical pharmacy specialist. The pharmacist will call patients and offer an individualized pharmacotherapy prescription. The patient must opt-out for it not to be sent to their pharmacy. The patient will also receive brief motivational interviewing and behavioral counseling from the pharmacist.
16408340|NCT05019066|Dietary Supplement|Herbal Supplementation|A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
16408343|NCT05014919|Drug|Vortioxetine|Tablets
16408344|NCT05014919|Drug|Placebo|Tablets
16408345|NCT05014815|Drug|Tislelizumab|Tislelizumab intravenous injection
16408346|NCT05014815|Drug|Ociperlimab|Ociperlimab intravenous injection
16408347|NCT05014815|Drug|histology-based chemotherapy|Administered intravenously
16408348|NCT05014815|Drug|Placebo|Administered as an intravenous injection
16408354|NCT05008224|Biological|Pembrolizumab|"200 mg IV administered on Day 1 of each 3-week cycle for 3 cycles during pembrolizumab monotherapy.
~400 mg IV administered on Day 1 of each 6-week cycle for 4 cycles as pembrolizumab consolidation."
16408355|NCT05008224|Drug|Doxorubicin|"25 mg/m^2 IV administered on Days 1 and 15 of each 4-week cycle for 2 cycles in all participants after PET2 and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age).
~35 mg/m^2 IV administered on Day 1 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve, <60 years of age)."
16408356|NCT05008224|Drug|Vinblastine|6 mg/m^2 IV administered on Days 1 and 15 of each 4-week cycle for 2 cycles after PET2 (all participants) and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age).
16408357|NCT05008224|Drug|Dacarbazine|375 mg/m^2 IV on Days 1 and 15 of each 4-week cycle for 2 cycles after PET2 (all participants) and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age).
16408358|NCT05008224|Drug|Bleomycin|10 units/m^2 IV administered on Day 8 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).
16408359|NCT05008224|Drug|Etoposide|200 mg/m^2 IV administered on Days 1-3 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).
16408360|NCT05008224|Drug|Cyclophosphamide|1250 mg/m^2 IV administered on Day 1 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).
16408361|NCT05008224|Drug|Vincristine|1.4 mg/m^2 IV on Day 8 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve &<60 years of age).
16408362|NCT05008224|Drug|Procarbazine|100 mg/m^2 orally (PO) administered on Days 1-7 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).
16408363|NCT05008224|Drug|Prednisone|40 mg/m^2 PO administered on Days 1-14 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).
16408364|NCT05008185|Procedure|Regenerative Peripheral Nerve Interface (RPNI) surgery|Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
16408365|NCT05008185|Procedure|Traction Neurectomy|Surgeons will perform neuroma resection and traction neurectomy,
16408366|NCT05006248|Device|Conventional robotic continuous passive movement training|The participants will be single-blinded and wear the M1 robotic device on their affected/weaker foot, and complete up to 30 minutes of continuous passive movement per training session. The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session.
16408367|NCT05006248|Device|Visual Feedback|The participants will be single-blinded and wear the M1 robotic device in transparency mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session. The transparency mode of the robotic device compensates for its weight and friction so that the participant does not feel weight while moving the device.
16408368|NCT05006248|Device|Haptic and Visual Feedback|The participants will be single-blinded and wear the M1 robotic device in assistance mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session. The assistance mode of the robotic device applies assistive/resistive torque based on muscle activity.
16408369|NCT05005312|Drug|PF-07321332|Tablet
16408370|NCT05005312|Drug|Ritonavir|PK Boosting agent
16408376|NCT05003401|Device|HabitAware Keen2|Participants will receive an awareness bracelet to be worn on the dominant wrist over a period of 4 weeks. The bracelet device will vibrate when the participant is engaging in hair pulling behaviors. As hair pulling behaviors may occur outside of awareness (i.e., automatic pulling behaviors), this vibration and detection is anticipated to increase the participants awareness of hair pulling behaviors.
16408377|NCT05001360|Drug|XBI-302 + Nivolumab|After gut preparation, a single dose of FMT will be performed via oral administration. Subsequently, nine combined treatment cycles that composed of anti-PD-1 infusions (Nivolumab at 240 mg, q2w) and additional FMT capsules, and 3 single treatment cycles of anti-PD-1 infusions will be administered.
16408378|NCT04999839|Drug|NDI-034858 study drug|Dosage Level - 1
16408379|NCT04999839|Drug|NDI-034858 study drug|Dosage Level - 2
16408380|NCT04999839|Drug|NDI-034858 study drug|Dosage Level - 3
16408381|NCT04999839|Drug|NDI-034858 study drug|Dosage Level - 4
16408382|NCT04999839|Other|Placebo|Placebo
16408383|NCT04996069|Device|Crest Whitening Emulsions|Subjects with Xerostomia will be asked to apply the study intervention product to their teeth up to 4 times per day for 1 week to investigate if the study intervention product increases saliva production in this dry mouth populaiton.
16408384|NCT04993911|Other|Experimental Group|"Assessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks. Each session will include a 5-min warm-up on a fitness bike or treadmill before commencement of the program and a 5-min cool period. Participants of this group will receive balance training with conventional treatment. Participants will perform between 2 sets of 5 and 7 repetitions of each exercise.
~Single leg balance
~Walking forward
~Walking backward
~Side stepping
~Walk heel to toe
~Static exercises with eyes close or open
~CONVENTIONAL EXERCISE PROGRAM :
~TENS for 15 minutes
~Hot pack for 15 minutes
~Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
~Quadriceps/hamstring isometric exercises.
~ROM and active stretching of the hamstring and quadriceps muscle.
~Active ankle pump.
~Squats,step-up, sit to stand, calf raises
~Straigh leg raising exercise in crook lying position"
16408385|NCT04993911|Other|Control Group|"Participants of this group will receive only conventional therapy which will include; before beginning the program, each session will feature a 5-minute warm-up on a fitness bike or treadmill, followed by a 5-minute cool-down. Participants of this group will receive only conventional therapy which will include.
~CONVENTIONAL EXERCISE PROGRAM :
~TENS for 15 minutes
~Hot pack for 15 minutes
~Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
~Quadriceps/hamstring isometric exercises.
~ROM and active stretching of the hamstring and quadriceps muscle.
~Active ankle pump.
~Squats,step-up, sit to stand, calf raises
~Straigh leg raising exercise in crook lying position"
16408386|NCT04992065|Drug|NNC0385-0434 A 15 mg|15 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
16408387|NCT04992065|Drug|NNC0385-0434 A 40 mg|40 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
16408388|NCT04992065|Other|Placebo I A (for NNC0385-0434 A 15 mg)|Placebo administered as 1 tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level
16408389|NCT04992065|Drug|NNC0385-0434 A 100 mg|"100 mg administered as one oral tablet once daily in the morning in a fasting state.
~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.
~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces)."
16408390|NCT04992065|Other|Placebo I A (for NNC0385-0434 A 40 mg)|"Placebo administered as one tablet once daily in the morning in a fasting state.
~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.
~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
~placebo tablets are sized match to the active arm within dose level"
16408391|NCT04992065|Other|Placebo II A (for NNC0385-0434 A 100 mg)|"Placebo administered as one tablet once daily in the morning in a fasting state.
~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.
~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
~placebo tablets are sized match to the active arm within dose level"
16408392|NCT04992065|Drug|Evolocumab 140 mg/mL, Repatha®|"Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick® autoinjector (single-use).
~Dose volume: 1 mL"
16408393|NCT04991753|Other|Placebo|Placebo infusion will be administered intravenously.
16408394|NCT04991753|Drug|Nipocalimab|Nipocalimab infusions will be administered intravenously.
16408395|NCT04990141|Procedure|Peripheral blood collection in cases group|Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in cases group
16408396|NCT04990141|Procedure|Peripheral blood collection in control group|Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in control group
16408397|NCT04986839|Drug|Paracetamol injection|Intravenous Paracetamol
16408398|NCT04986839|Drug|Ibuprofen injection|Intravenous Ibuprofen
16408399|NCT04986150|Other|Resistance exercise|Acute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines)
16408400|NCT04980833|Drug|Alpelisib|Participant's treatment plan has been established by the treating physician, within the global compassionate use framework. Doses permitted are 50, 125, 200 and 250 mg.
16408401|NCT04975100|Drug|Sarcosine and SSRI|Patients in the test group will get Sarcosine 500 mg capsules once daily as an add-on to ongoing SSRI treatment
16408402|NCT04975100|Drug|Placebo and SSRI|Patients in the control group will get identical-looking capsules containing placebo in addition to SSRI at an once daily dose
16408403|NCT04974645|Device|W-SUDs|Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
16408404|NCT04974645|Other|Education Only|The education only control intervention is a form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.
16408405|NCT04974528|Biological|Afrezza|"Pharmaceutical form: powder
~Route of administration: inhalation"
16408406|NCT04974528|Biological|Rapid-Acting Insulin Analog|"Pharmaceutical form: clear and colorless solution for injection
~Route of administration: subcutaneous"
16408407|NCT04974528|Biological|Basal Insulin|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16408408|NCT04973332|Device|Intracranial thrombectomy stent|Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
16408412|NCT04971226|Drug|Imatinib|Comes in 100 mg and 400 mg tablets and taken orally
16408413|NCT04971226|Drug|Nilotinib|Comes in 150 mg capsules and taken orally
16408414|NCT04971226|Drug|Bosutinib|Comes in 100 mg and 400 mg tablets and taken orally
16408415|NCT04971226|Drug|Dasatinib|Comes in 70 mg and 100 mg tablets and taken orally
16408416|NCT04971226|Drug|Asciminib|Comes in 40 mg tablets and taken orally
16408417|NCT04970654|Drug|somapacitan|Somapacitan (0.16 mg/kg/week) will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
16408418|NCT04970654|Drug|Norditropin®|Norditropin® (0.034 mg/kg/day) will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
16408419|NCT04968964|Device|DiviTum® TKa assay|-Determines serum enzymatic activity of TK1
16408420|NCT04968964|Other|Study Care Plans|-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value
16408421|NCT04968912|Other|Placebo|Placebo infusion will be administered intravenously.
16408422|NCT04968912|Drug|Nipocalimab|Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
16408423|NCT04968912|Drug|Standard of Care Treatment|Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
16408424|NCT04963751|Other|Enhanced Recovery After Surgery (ERAS) Counseling to Patients|In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
16408425|NCT04963751|Other|Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver|In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
16408426|NCT04963738|Drug|JNJ-73763989|JNJ-73763989 will be administered as a single SC injection.
16408427|NCT04963153|Drug|Enfortumab Vedotin|Given IV
16408428|NCT04963153|Drug|Erdafitinib|Given PO
16408429|NCT04962321|Behavioral|Wellness Education|Psychoeducation on relationships between mood, anxiety, eating, and exercise behaviors. One one-hour session each week for 8 weeks.
16408430|NCT04961996|Drug|Giredestrant|Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
16408431|NCT04961996|Drug|Endocrine Therapy of Physician's Choice|The endocrine therapy of physician's choice (TPC) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive TPC daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing TPC after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of TPC should be performed in accordance with the local prescribing information for the respective product.
16408432|NCT04961996|Drug|LHRH Agonist|A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
16408433|NCT04960228|Behavioral|Altruism Video|The video provides three vignettes about a diverse set of people who may be more vulnerable to serious health consequences from COVID-19. In each of the stories, high vaccine uptake of those around these vulnerable individuals serves to protect them. This communicates that getting the COVID-19 vaccine can be done for prosocial reasons and to foster a sense of community, as it provides protection not only to oneself, but also to others.
16408434|NCT04960228|Behavioral|COVID-19 Informational Text|The topics included in the text are how COVID-19 spreads, hygiene, physical distancing, and travel restrictions. Participants will complete three comprehension questions, one after each of the following sections: hygiene, physical distancing, and travel restrictions.
16408435|NCT04959916|Other|Group Metacognitive Therapy|Group Meta-Cognitive Therapy (Group-MCT) will consist of six weekly sessions delivered by two trained trainee clinical psychologists over 1-1.5 hours. The aims of the intervention are to help participants develop knowledge that can facilitate control of worry, rumination and attention, and to modify the metacognitive beliefs that maintain these unhelpful patterns of thinking. There are eight major treatment techniques that will be used across the six sessions, namely (1) formulation, (2) socialisation, (3) the Spatial Attentional Control Exercise, (4) detached mindfulness, (5) worry and rumination postponement, (6) modifying metacognitive beliefs about the uncontrollability and danger of worry and rumination, (7) a 'helpful behaviours prescription', and (8) individual treatment summaries. Sessions include group discussions, experiential learning and homework tasks that participants will be expected to complete between sessions.
16408436|NCT04952402|Biological|Moderna mRNA-1273 COVID-19 vaccine|100 µg (0.5 mL) to be administered intramuscularly (IM) at Day 0 and Day 28.
16408437|NCT04952402|Biological|Community-provided mRNA-based COVID-19 vaccine|Two dose series.
16408438|NCT04952402|Biological|Community-Provided Moderna mRNA-1273 COVID-19 Vaccine|Participants will receive (or have recently received) a community-provided Moderna mRNA-1273 COVID-19 vaccine at (or before) Day 0 and study-provided Moderna mRNA-1273 COVID-19 vaccine, 100 µg (0.5 mL) to be administered intramuscularly (IM) at at least 28 days apart.
16408439|NCT04950764|Drug|Seladelpar 10 mg|Seladelpar 10 mg single oral dose
16408440|NCT04950764|Drug|Seladelpar 10 mg or less|Seladelpar 10 mg or less, once daily for 28 days
16408443|NCT04946110|Device|Electromagnetic stimulation|Electromagnetic stimulation of the phrenic nerve
16408445|NCT04939987|Drug|Tramadol|Opioid Control Cohort (One treatment selected)
16408446|NCT04939987|Drug|Gabapentin|Experimental Cohort (Multimodal Approach)
16408447|NCT04939987|Drug|Hydrocodone-Acetaminophen|Opioid Control Cohort (One treatment selected)
16408448|NCT04939987|Drug|Oxycodone-Acetaminophen|Opioid Control Cohort (One treatment selected)
16408449|NCT04939987|Drug|Ketorolac|Experimental Cohort (Multimodal Approach)
16408450|NCT04939987|Drug|Acetaminophen|Experimental Cohort (Multimodal Approach)
16408451|NCT04939987|Drug|Ketorolac tromethamine|Experimental Cohort (Multimodal Approach)
16408452|NCT04939987|Drug|Ketamine|Experimental Cohort (Multimodal Approach)
16408453|NCT04935359|Drug|NIS793|Concentrate for solution infusion (Liquid in Vial)
16408454|NCT04935359|Drug|Nab-paclitaxel|Powder for solution for infusion
16408455|NCT04935359|Drug|Gemcitabine|Powder for solution for infusion
16408456|NCT04935359|Drug|Placebo|Dextrose 5% in water (D5W) solution ofr infusion
16408926|NCT04467879|Device|Zona Plus|Zona Plus
16408464|NCT04933552|Other|Siponimod|Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled.
16408468|NCT04932057|Other|Action observation Training|Action observation training is a relatively new rehabilitation approach in which the subject is asked to carefully observe the actions presented through a video clip or performed by an operator.
16408469|NCT04932057|Other|Action Practice|Participants perform an upper extremity functionality test a couple of times.
16408470|NCT04932057|Other|Observation|Participants will watch a slide show of landscape
16408471|NCT04929405|Behavioral|ADAPT|ADAPT, is multi-modal to promote a targeted approach to individual parental bereavement experiences and is not time or geographically limited. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. Our interdisciplinary team developed a web-based, multi-modal intervention, labeled ADAPT, that incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using a Quick Response (QR) bar code or weblink.
16408472|NCT04929223|Drug|Inavolisib|Inavolisib will be administered orally as per schedule specified in the respective arms.
16408473|NCT04929223|Drug|Bevacizumab|Bevacizumab IV will be administered as per specified in the respective arm.
16408474|NCT04929223|Drug|Cetuximab|Cetuximab IV will be administered as per specified in the respective arm.
16408476|NCT04927312|Drug|PF-06947386|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.
16408477|NCT04927312|Drug|Metronidazole|Metronidazole 0.5 g solution for injection.
16408478|NCT04923542|Radiation|Stereotactic Radiosurgery (SRS)|Patients will receive single session SRS to intact brain metastases and post-operative cavities. For intact brain metastases, this will be 15 Gy to lesions between 31-40 mm, 18 Gy to 21- 30 mm, and 24 Gy to lesions measuring ≤ 20 mm.
16408479|NCT04923542|Drug|Abemaciclib|Abemaciclib is an orally administered selective small-molecule inhibitor of CDK4 and CDK6 that is 14 times more potent against CDK4 than CDK6 in enzymatic assays that is approved for the treatment of advanced or metastatic breast cancers. Abemaciclib will be administered at a dose of 150 mg twice daily.
16408480|NCT04923542|Drug|Endocrine therapy|Abemaciclib will be administered with standard of care endocrine therapy. Endocrine therapy can consist of fulvestrant or an aromatase inhibitor. Dosing of concurrent endocrine therapy with abemaciclib should follow standard dosing and safety guidelines.
16408481|NCT04922697|Other|Educational Intervention|Watch educational videos and use wearable air pollution sensor
16408482|NCT04922697|Other|Questionnaire Administration|Complete questionnaires
16408483|NCT04916990|Behavioral|CARES Intervention|Nurse navigators and masters levels counselors will meet with participants up to 10 times each (10 navigation and 10 counseling) over a 6 month period. The number of sessions will be determined by the length of the patient's treatment. The timing of each session will be guided by a regular assessment to reduce the time from diagnosis to initiation of treatment and the time between subsequent treatments. Sessions will occur at key transition points during treatment to target the factors associated with treatment delays, reduced Quality of Care and poor Patient Reported Outcomes
16408484|NCT04916470|Drug|Semaglutide|Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.
16408485|NCT04916470|Drug|Placebo (Semaglutide)|Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.
16408488|NCT04914897|Drug|SAR444245|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
16408489|NCT04914897|Drug|Pembrolizumab|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
16408490|NCT04914897|Drug|Carboplatin|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
16408491|NCT04914897|Drug|Cisplatin|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
16408492|NCT04914897|Drug|Nab-paclitaxel|Pharmaceutical Form: powder for solution for infusion Route of Administration: intravenous infusion
16408493|NCT04914897|Drug|Pemetrexed|Pharmaceutical Form: powder for solution for infusion Route of Administration: intravenous infusion
16408533|NCT04886232|Device|VP1 Lido US|Hyaluronic acid dermal filler containing lidocaine
16408534|NCT04886232|Device|Restylane Lyft Lidocaine|Hyaluronic acid dermal filler containing lidocaine
16408494|NCT04913467|Other|Groningen Anti-Inflammatory Diet (GrAID)|Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions.
16408495|NCT04913467|Dietary Supplement|ColoVit capsule|Vitamin B2/B3/C supplement in a ColoPulse-coated capsule
16408496|NCT04913467|Other|ColoPulse-placebo capsule|A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit
16408497|NCT04912479|Device|connected watch|connected watch that provide to patients with information on their sleep quality and their performed activities
16408498|NCT04908722|Biological|Ad26.COV2.S|Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
16408499|NCT04908683|Biological|Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF|Participants will receive a single IM injection of an RSV vaccine.
16408500|NCT04908683|Biological|Placebo|Participants will receive a single IM injection of matching placebo.
16408501|NCT04903626|Drug|Glecaprevir/Pibrentasvir (GLE/PIB)|Oral tablets
16408504|NCT04901299|Drug|NERATINIB|Neratinib will be given orally once daily on a continuous daily dosing schedule i.e., no break in dosing. Dosage per protocol
16408505|NCT04901299|Drug|FULVESTRANT|Fulvestrant will be given via injection every two weeks for the first 28-day cycle and every four weeks thereafter, dosage per protocol
16408506|NCT04899336|Biological|ExPEC9V|ExPEC9V will be administered as an IM injection.
16408507|NCT04899336|Other|Placebo|Matching placebo will be administered as an IM injection.
16408508|NCT04897256|Behavioral|Turning Boot Camp exercise program|Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focus on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting, increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging.
16408509|NCT04897074|Device|AKL-T01|"AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor driving task."
16408511|NCT04895761|Biological|DPX-Survivac|"DPX is a novel formulation that when combined with target antigens acts to activate T cells. It is a lipid-based formulation that creates a long lasting depot at the site of injection, forcing an active uptake by antigen presenting cells (APCs). APCs traffic to regional lymph nodes where naïve T cells are activated, inducing strong and sustained immune responses. All arms will receive DPX-Survivac on weeks 2 and 5."
16408512|NCT04895761|Drug|Letrozole 2.5mg|Aromatase inhibitor all arms will receive
16408513|NCT04895761|Drug|Cyclophosphamide 50mg|oral chemotherapy used in the neoadjuvant setting for Arm C only
16408514|NCT04895761|Radiation|XRT 10Gy x2|Directed radiation at week 4 for Arm B only
16408515|NCT04895046|Drug|Niraparib|300 mg taken orally (all cycles)
16408516|NCT04895046|Drug|Dostarlimab|500 mg (cycles 1-4) intravenously
16408517|NCT04895046|Drug|Dostarlimab|1000 mg (cycle 5+) intravenously
16408518|NCT04894916|Other|My Diabetes Care Mobile (MDC-m)|My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.
16408519|NCT04894305|Biological|Ad26.COV2.S|Ad26.COV2.S will be administered as IM injection.
16408520|NCT04893759|Drug|Pelcitoclax|Multiple dose cohorts, 30 minute IV infusion, once a week, 28 days as a cycle
16408521|NCT04893486|Drug|PTX-022|QTORIN 3.9 % Sirolimus Topical Gel
16408522|NCT04893486|Drug|Vehicle comparator|Vehicle comparator topical gel
16408523|NCT04893226|Behavioral|Time-Restricted Feeding (TRF)|Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.
16408527|NCT04889937|Device|PointCheck|PointCheckTM is intended for use to aid in the assessment of severe neutropenia in the home or clinic setting in subjects receiving myelosuppressive chemotherapy with intermediate to high febrile neutropenia risk. The device non-invasively captures real-time videos of blood flow in the nailfold microcirculation and utilizes visible light, a microscope and a computer vision software to provide a qualitative result. The device is limited to use as a preliminary assessment tool in conjunction with standard of care, including temperature monitoring and clinical assessment. It is not to be used as a stand-alone determinant of severe neutropenia or for any other diagnostic purpose
16408528|NCT04887831|Drug|Trilaciclib|Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered.
16408529|NCT04887831|Drug|Gemcitabine|Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle
16408530|NCT04887831|Drug|Cisplatin|Cisplatin administered IV on Day 1 of each 21-day cycle
16408531|NCT04887831|Drug|Carboplatin|Carboplatin administered IV on Day 1 of each 21-day cycle
16408532|NCT04887831|Drug|Avelumab|Avelumab will be dosed on Day 1 of each 14-day maintenance cycle
16408536|NCT04884360|Other|Matching placebo|Matching placebo tablets taken orally at a dose of 300 mg twice daily
16408537|NCT04882878|Other|Placebo|Placebo will be administered intravenously.
16408538|NCT04882878|Drug|Nipocalimab|Nipocalimab dose 1 and dose 2 will be administered intravenously.
16408539|NCT04882878|Drug|Standard-of-care treatment|Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
16408542|NCT04881045|Biological|PF-07257876|CD47-PDL-1 bispecific antibody
16408543|NCT04880642|Drug|C21|C21
16408544|NCT04880642|Drug|Placebo|Placebo
16408545|NCT04877678|Drug|Bepotastine|10 mg Bepotastine, twice a day
16408546|NCT04877678|Drug|Placebo|Identical looking placebo, twice a day
16408547|NCT04877054|Behavioral|Adherence Treatment Program|4 telehealth sessions including a combination of psycho/medical education plus a motivational interviewing component.
16408548|NCT04877054|Behavioral|Education only|The control group will receive an education-only session. Education will include medication purpose and adherence strategy recommendations delivered in a single telehealth session.
16408549|NCT04874948|Drug|500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043|Single oral administration of 14C-labeled radioactive 500mg BTZ-043
16408552|NCT04865978|Drug|Apixaban|Patients randomized to apixaban will be started on a dose of 5 mg BID.
16408553|NCT04865978|Drug|Warfarin|Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.
16408554|NCT04865978|Device|LVAD implant|Subjects will undergo HeartMate 3 LVAD implant prior to randomization
16408555|NCT04865939|Procedure|sterile water irrigation|Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).
16408556|NCT04865939|Drug|Gemcitabine|Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).
16408557|NCT04863950|Drug|Lomustine|"For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced.
~For non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1.
~For both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks."
16408558|NCT04863950|Drug|Imipramine Hydrochloride|"For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days.
~For non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days."
16408559|NCT04863664|Device|Defibrillation|Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
16408560|NCT04858334|Drug|Olaparib|Given PO
16408561|NCT04858334|Drug|Placebo Administration|Given PO
16408562|NCT04853368|Drug|Galicaftor|Oral capsules
16408563|NCT04853368|Drug|Placebo|Oral capsules
16408564|NCT04853368|Drug|Navocaftor|Oral capsules
16408565|NCT04853368|Drug|ABBV-119|Oral capsules
16408566|NCT04848558|Drug|Nipocalimab|Participants will receive IV infusion or SC injection of nipocalimab.
16408567|NCT04848558|Other|Placebo|Participants will receive IV infusion or SC injection of placebo.
16408571|NCT04846439|Biological|CAR-T infusion|Sequential infusion of CD19 and BCMA autologous chimeric antigen receptor T cells, the infusion dose was determined according to the body weight of the subject and the effective content of cell preparation.
16408572|NCT04839042|Biological|SC-Ad6-1|SC-Ad6-1, I.M., single or multiple-dose
16408573|NCT04839042|Biological|SC-Ad6-1|SC-Ad6-1, I.N., single or multiple-dose
16408574|NCT04832971|Drug|ARO-ANG3|2 doses of ARO-ANG3 by subcutaneous (sc) injection
16408575|NCT04832971|Drug|Placebo|calculated volume to match active treatment by sc injection
16408576|NCT04831827|Other|IVR Reminder|Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
16408577|NCT04831827|Other|Phone call from research team|Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.
16408578|NCT04831827|Other|EHR Portal message|Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.
16408579|NCT04830137|Drug|NX-2127|Oral NX-2127
16408580|NCT04829383|Drug|Atezolizumab|1,200 mg
16408581|NCT04829383|Drug|Bevacizumab|15 mg/kg
16408582|NCT04828161|Drug|ensovibep|Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only
16408583|NCT04828161|Drug|Placebo|Phase 2/ Part A : 3 active treatment arms vs placebo, IV on day 1 only Phase 3/ Part B: 1 active treatment arm (selected dose from Part A) vs placebo, IV on day 1 only
16408927|NCT04467879|Device|Control Device|Control Device
16408584|NCT04820959|Biological|Biopsies|"Three endomyocardial intraoperative biopsies were performed on the left ventricle.
~Resection of the left atrium in the event of atrial fibrillation."
16408585|NCT04820959|Biological|Blood sampling|Pre-operative blood sampling
16408587|NCT04819100|Drug|Selpercatinib|Administered orally.
16408588|NCT04819100|Drug|Placebo|Administered orally.
16408589|NCT04818346|Drug|INCB054707|INCB054707 will be administered once daily
16408590|NCT04818346|Drug|Placebo|Placebo or INCB054707 will be administered once daily
16408596|NCT04814368|Biological|canakinumab|intra-articular injection (into the knee)
16408597|NCT04814368|Biological|LNA043|intra-articular injection (into the knee)
16408598|NCT04814368|Other|Placebo to canakinumab|intra-articular injection (into the knee)
16408599|NCT04811092|Drug|Sotatercept|Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
16408600|NCT04811092|Other|Placebo|Placebo
16408605|NCT04799275|Drug|Cyclophosphamide|Given IV
16408606|NCT04799275|Drug|Doxorubicin Hydrochloride|Given IV
16408607|NCT04799275|Drug|Oral Azacitidine|Given PO
16408608|NCT04799275|Drug|Prednisone|Given PO
16408609|NCT04799275|Other|Questionnaire Administration|Ancillary studies
16408610|NCT04799275|Biological|Rituximab|Given IV or SC
16408611|NCT04799275|Drug|Vincristine Sulfate|Given IV
16408612|NCT04799249|Drug|Trilaciclib|Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
16408613|NCT04799249|Drug|Placebo|Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
16408614|NCT04799249|Drug|Gemcitabine|Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
16408615|NCT04799249|Drug|Carboplatin|Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
16408616|NCT04795622|Device|Ultherapy treatment|Focused ultrasound energy delivered below the surface of the skin
16408617|NCT04795622|Device|Untreated-control / delayed-treatment|Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)
16408618|NCT04794075|Other|Therapeutic Education and Nursing Support Program for Supportive Care|"In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy.
~A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program."
16408619|NCT04793100|Other|Ophthalmologic exam at inclusion and 12 months after CRVO|"As part of routine care : OCT-B (Optical coherence tomography-B), OCT-angiography (Optical coherence tomography and fluorescein angiography after pupillary dilatation (at inclusion only)
~Added by the study :
~Assessment of best corrected visual acuity in letters read and validated using the ETDRS scale ;
~The shooting of a 10 second infrared movie by the Heidelberg Spectralis device centered on the head of the optic nerve (at inclusion only)
~A measurement of the eye tension with an air tonometer (at inclusion only)
~A blood pressure measurement (diastolic and systolic) and pulse measurement (at inclusion only)
~A color retinophotography (Optos) with autofluorescence images
~A color Doppler ultrasound of the optic nerve of both eyes will be performed, for patients treated at the Foundation A de Rothschild Hospital only."
16408620|NCT04793100|Drug|Treatment standardization with aflibercept|For patients requiring intravitreal injection
16408621|NCT04791371|Behavioral|Cardiovascular exercise|15 weeks of cardiovascular exercise 3x/week for 50 minutes/session
16408622|NCT04784715|Drug|Trastuzumab deruxtecan|Administered by intravenous infusion
16408623|NCT04784715|Drug|Placebo|Administered by intravenous infusion
16408624|NCT04784715|Drug|Taxane|Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
16408625|NCT04784715|Drug|Pertuzumab|Administered by intravenous infusion
16408626|NCT04784715|Drug|Trastuzumab|Administered by intravenous infusion
16408627|NCT04783389|Drug|CBP-201|CBP-201 subcutaneous (SC) injection.
16408628|NCT04783389|Drug|Placebo|Placebo subcutaneous (SC) injection.
16408629|NCT04782687|Drug|Selinexor|oral drug that comes in 20 mg tablets
16408786|NCT04586231|Drug|Cabozantinib|Tablet available in 20 mg, 40 mg and 60 mg dosages
16408630|NCT04782687|Drug|Dexamethasone Oral|For all patients, the weekly dose of dexamethasone (or equivalent) must total 40 mg. However, those of 65 years-old or older may be administered the weekly dose of 20 mg dexamethasone. Dexamethasone 40 mg on Days 1, 8, 15, 22 of each cycle.
16408631|NCT04782687|Drug|Daratumumab|"Patients will receive daratumumab subcutaneously (SC, or under the skin) as an injection. The recommended dosage of the SC formulation is 1,800 mg daratumumab and 30,000 units hyaluronidase administered SC into the abdomen over approximately 3 to 5 minutes according to recommended schedule.
~Daratumumab 1800 mg subcutaneously once weekly in Cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter."
16408632|NCT04782687|Drug|Lenalidomide|Patients will receive a 21-day supply of lenalidomide (25 mg) as oral capsules, as appropriate, for each 28-day treatment cycle
16408633|NCT04777409|Drug|Semaglutide|Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
16408634|NCT04777409|Drug|Placebo (semaglutide)|Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks
16408635|NCT04777396|Drug|Semagludtide|Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
16408636|NCT04777396|Drug|Placebo (semaglutide)|Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks
16408637|NCT04774146|Procedure|pars plana vitrectomy|silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange
16408638|NCT04774094|Drug|Zavicefta, Ceftazidime-Avibactam|Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.
16408639|NCT04766073|Procedure|Niche prevention suture|This group will have the uterus sutured in two layers using a new technique.
16408640|NCT04765384|Biological|Ad26.COV2.S|Participants will receive IM injection of Ad26.COV2.S.
16408641|NCT04764448|Drug|belcesiran|belcesiran will be administered subcutaneously (SC). Dose level to be determined upon review of data from DCR-A1AT-101.
16408642|NCT04764448|Other|Placebo|Placebo will be administered subcutaneously (SC). Sterile normal saline (0.9% NaCL) matching volume of belcesiran doses will be administered subcutaneously (SC).
16408643|NCT04762979|Drug|Alpelisib|Alpelisib 300mg, PO, days 1-28 of each cycle.
16408644|NCT04762979|Drug|Fulvestrant|Fulvestrant 500mg, IM, once monthly
16408645|NCT04762979|Drug|Aromatase inhibitor|Aromatase Inhibitor, administered per standard of care
16408646|NCT04762758|Drug|(RS)-baclofen, naltrexone hydrochloride and D-sorbitol|oral fixed dose combination
16408647|NCT04762758|Drug|Placebo|liquid oral solution
16408648|NCT04760028|Procedure|Adjusting the depth of anesthesia|After the main procedure, the depth of anesthesia can be adjusted as needed
16408649|NCT04757636|Biological|2.0 mg OPT-302|intravitreal injection
16408650|NCT04757636|Biological|2.0 aflibercept|intravitreal injection
16408651|NCT04757636|Procedure|Sham|intravitreal injection
16408652|NCT04757610|Biological|2.0 mg OPT-302|intravitreal injection
16408653|NCT04757610|Biological|0.5 mg ranibizumab|intravitreal injection
16408654|NCT04757610|Procedure|Sham|intravitreal injection
16408655|NCT04756505|Drug|Bintrafusp Alfa|Given IV
16408656|NCT04756505|Biological|Immunocytokine NHS-IL12|Given SC
16408657|NCT04756505|Radiation|Radiation Therapy|Undergo radiation therapy
16408658|NCT04753437|Drug|Clarithromycin|Clarithromycin tablets.
16408659|NCT04753437|Drug|Amoxicillin|Amoxicillin capsules.
16408660|NCT04753437|Drug|Bismuth potassium citrate|Bismuth potassium citrate tablets.
16408661|NCT04753437|Drug|Esomeprazole|Esomeprazole tablets.
16408662|NCT04753437|Drug|Vonoprazan|Vonoprazan tablets.
16408663|NCT04751942|Device|Non-compressive Bioactive Garment|patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
16408664|NCT04751942|Device|thrombo-embolic deterrent|patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
16408665|NCT04751370|Biological|Ipilimumab|Given IV
16408666|NCT04751370|Biological|Nivolumab|Given IV
16408667|NCT04751370|Radiation|Radiation Therapy|Undergo short-course radiation therapy
16408668|NCT04751370|Procedure|Total Mesorectal Excision|Undergo TME
16408670|NCT04750226|Drug|ABBV-951|Solution for continuous subcutaneous infusion (CSCI).
16408671|NCT04747275|Drug|Oral tablet levothyroxine (L-T4)|Investigation of tolerability, palatability, and adherence of maintained oral tablet levothyroxine (L-T4)
16408672|NCT04747275|Drug|Liquid stable levothyroxine (L-T4) Tirosint-SOL|Investigation of tolerability, palatability, and adherence of liquid levothyroxine (L-T4)
16408673|NCT04740346|Diagnostic Test|Computed tomography, Chest X-ray, and blood test|CT will be performed every 3 months after gastrectomy in the 3-months follow-up group. CT will be performed every 6 months after gastrectomy in the 6 months follow-up group.
16408674|NCT04737330|Drug|Secukinumab|Secukinumab 300 mg s.c. at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
16408675|NCT04737330|Drug|Placebo|Placebo s.c. at Baseline, Weeks 1, Week 2, Week 3, Week 4, Week 8, Week 12
16408676|NCT04737109|Drug|Ipatasertib|Ipatasertib
16408677|NCT04737109|Drug|Darolutamide|Darolutamide
16408678|NCT04737109|Drug|Androgen Deprivation Therapy|ADT per institutional standards
16408679|NCT04735354|Drug|sacubitril/valsartan|There is no treatment allocation. Patients administered sacubitril/valsartan by prescription that have started before inclusion of the patient into the study will be enrolled.
16408680|NCT04721197|Other|Egg vouchers|30-day egg vouchers will be provided monthly, in addition to standard of care.
16408681|NCT04721197|Other|Standard of Care|Participants will continue to receive the standard of care. No egg vouchers.
16408682|NCT04717453|Other|No Intervention|No Intervention
16408683|NCT04716231|Biological|Atacicept|Once weekly subcutaneous (SC) injections by prefilled syringe
16408684|NCT04716231|Other|Placebo to match Atacicept|Once weekly subcutaneous (SC) injections by prefilled syringe
16408829|NCT04535544|Drug|Entecavir (ETV) monohydrate|ETV monohydrate film coated tablet will be administered orally.
16408685|NCT04714372|Drug|Daratumumab/rHuPH20|Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
16408686|NCT04714372|Drug|FT538|FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
16408687|NCT04714372|Drug|Fludarabine|Fludarabine 25 mg/m^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days ((Day -4, and Day -3)
16408688|NCT04714372|Drug|Cyclophosphamide|Cyclophosphamide 300 mg/m^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given
16408689|NCT04711850|Drug|Imlifidase|Immunoglobulin G degrading enzyme of Streptococcus pyogenes
16408690|NCT04699838|Drug|Cisplatin|Cisplatin
16408691|NCT04699838|Drug|Carboplatin|Carboplatin
16408692|NCT04699838|Drug|Etoposide|Etoposide
16408693|NCT04699838|Drug|Durvalumab|Durvalumab
16408694|NCT04699838|Drug|Ceralasertib|Ceralasertib
16408695|NCT04697212|Behavioral|Healthcare team- + patient-directed intervention|"Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities, and will also complete a patient prompt list that elicits strategies that they prefer the healthcare team to use during their visit."
16408696|NCT04697212|Behavioral|Healthcare team-directed intervention|Participants will experience a clinical encounter with a healthcare team that has received training on evidence-based communication strategies for patients with communication disabilities.
16408698|NCT04684420|Drug|Glucophage® XR Test|Participants will receive a single oral dose of 500 mg of test Glucophage® XR tablet under fasting or fed conditions.
16408699|NCT04684420|Drug|Glucophage® XR Reference|Participants will receive a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.
16408700|NCT04677569|Drug|ALIS|Inhalation via nebulization over approximately 6 to 15 minutes
16408701|NCT04677569|Drug|Azithromycin|Oral tablet
16408702|NCT04677569|Drug|Ethambutol|Oral tablet
16408703|NCT04677569|Drug|ELC (matching placebo for ALIS)|Inhalation via nebulization over approximately 6 to 15 minutes
16408704|NCT04677504|Drug|Atezolizumab|Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
16408705|NCT04677504|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg intravenously on Day 1 of each 21-day cycle after atezolizumab.
16408706|NCT04677504|Other|Placebo|Placebo matching bevacizumab will be administered intravenously on Day 1 of each 21-day cycle after atezolizumab.
16408707|NCT04677504|Drug|Cisplatin|Cisplatin will be administered intravenously at a dose of 25 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
16408708|NCT04677504|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a dose of 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
16408709|NCT04676490|Other|RECORD-ED Card|Low-cost and low-tech recordable audio card containing language-concordant discharge instructions for families of children under age 10 presenting to the ED for asthma exacerbations with no or public insurance and a preference for English or Spanish. Recordable cards allow for multiple audio reviews of the instructions by multiple caregivers without dependence on access to the internet or smartphone technologies.
16408710|NCT04676490|Other|RECORD-ED Patient Portal|Audio recorded, language concordant discharge instructions via patient portal
16408711|NCT04675788|Drug|Progesterone|Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
16408712|NCT04675788|Drug|Ibutilide|Ibutilide 0.003 mg/kg administered to all subjects to modestly lengthen the QT interval
16408713|NCT04675788|Drug|Testosterone|Subjects will apply transdermal testosterone gel once daily every morning for 3 days
16408714|NCT04675788|Drug|Placebo|Lactose capsules
16408715|NCT04673058|Procedure|Spinal Manipulation|Intervention will be administered twice a week for 3 weeks. Each treatment session will be given in 20-minute sessions consisting of 10 minutes of manual examination and 10 minutes of manual treatment.
16408716|NCT04673058|Procedure|Sham Manipulation|The practitioner will primarily identify the areas where somatic dysfunction is detected and keep the application away from these areas. The patient will be positioned for treatment as in active therapy, but once in the lock position, a lower thrust will be given by releasing some back from the position.
16408717|NCT04672460|Drug|TALZENNA capsule|Current commercial talazoparib formulation 1 mg once daily given under fasting condition
16408718|NCT04672460|Drug|Talazoparib soft gel capsule|Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
16408719|NCT04672460|Drug|Talazoparib soft gel capsule|Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
16408720|NCT04670822|Behavioral|Breastfeeding promotion|The intervention group will receive multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).
16408721|NCT04670822|Behavioral|Attention placebo control|The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.
16408751|NCT04634344|Drug|DZD2269|A single dose of DZD2269 starting at 5 mg will be given on Cycle 0 and then followed by a wash-out period. Multiple doses of DZD2269 at the same dose level will be given once daily after the wash-out period.
16408830|NCT04535544|Drug|Tenofovir disoproxil|Tenofovir disoproxil film-coated tablet will be administered orally.
16408831|NCT04535544|Drug|Tenofovir alafenamide (TAF)|TAF film coated tablet will be administered orally.
16409304|NCT03885596|Drug|Acetaminophen Oral|1 g postoperative
16408723|NCT04668248|Other|Simulation|"The simulation will consist of a one-time, short immersive simulation session at the STRATUS Center for Medical Education at BWH. The session will be conducted for up to 4 interns at the same time, in accordance with social distancing practices at BWH. This simulation session will consist of 2 short, hands-on scenarios of simulated patient experiences with expert facilitators in the simulated hospital rooms to help providers identify when they are in the hot state and their reactions, and work on improving communication skills, differential diagnoses, and alternative therapeutic options. These scenarios are intended to simulate both in-person and virtual interactions that are common in the inpatient setting. During these trainings, we will use behavioral principles like time pressure and increasing cognitive load to simulate a hot state environment. After the scenarios, the facilitator will perform a debriefing session for the interns."
16408724|NCT04668248|Other|Online educational training|Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. This information will be in the form of electronically-delivered links to information already housed and available at BWH, including reviewing BWH guidelines and literature about transfusion reactions. The interns will be asked to answer several clinical questions about optimal prescribing. Albumin and related products are also high-risk medications often overprescribed on twilight shifts. Receiving education about another high-risk medication will reduce contamination and allow the ability to measure outcomes to other high-risk medications.
16408725|NCT04666259|Drug|ABL001|Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.
16408726|NCT04662632|Combination Product|VT-X7 Treatment System|Seven-day local antibiotic irrigation (alternating tobramycin sulfate and vancomycin HCl) via the VT-X7 Knee or Hip Spacer with alternating NPWT.
16408727|NCT04662632|Drug|SOC|Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per SOC. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines.
16408728|NCT04662632|Procedure|Two-stage exchange arthroplasty|Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
16408729|NCT04661033|Drug|Isatuximab SAR650984|Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
16408732|NCT04649359|Drug|Elranatamab (PF-06863135)|BCMA-CD3 bispecific antibody
16408733|NCT04647760|Behavioral|JOIN for ME|JOIN for ME is an empirically tested, effective weight management program for children ages 6-12 years.The curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are attended by the parent/caregiver and child, and occur at a location within their community setting (public housing or patient-centered medical home). Each session is 60 minutes and led by a certified Community Health Worker, with a private weigh-in for each dyad prior to the start of each session. Key behavioral targets include self-monitoring of dietary intake and physical activity, limiting LESS foods, limiting screen time, and weekly attendance. A family-based incentive structure is incorporated into the program such that parents/caregivers reinforce their children for achieving goals. Due to the COVID-19 pandemic, in-person sessions will be conducted virtually until it is safe to resume in-person group sessions.
16408734|NCT04647721|Device|Radiesse injectable implant (dermal filler)|Subdermal injection.
16408735|NCT04647721|Device|Restylane injectable implant (dermal filler)|Subdermal injection.
16408736|NCT04646044|Drug|Bempegaldesleukin|Administered as an intravenous infusion
16408737|NCT04646044|Drug|Standard of Care|Standard of Care Treatment for COVID-19 Infection
16408738|NCT04646044|Other|Placebo|Administered as an intravenous infusion
16408749|NCT04639713|Device|Tixel 2|Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.
16408750|NCT04639219|Drug|Trastuzumab deruxtecan|Trastuzumab deruxtecan (T-DXd) by intravenous infusion
16408752|NCT04632381|Drug|Zotatifin|Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR).
16408753|NCT04632381|Drug|Placebo|5% dextrose injection, USP
16408754|NCT04628949|Device|aScope™ Duodeno endoscope and aBox™ Duodeno|"The aScope™ Duodeno endoscope is a sterile single-use disposable duodenoscope indicated for endoscopic retrograde cholangiopancreatography (ERCP) procedures.The aScope™ Duodeno endoscope is designed to be used with aBox Duodeno, endoscopic accessories and other ancillary equipment for ERCP procedures.
~The aBox Duodeno is the console that is necessary for processing the endoscope camera´s video image, regarding the remote switches and output video and recorder data. The aBox Duodeno is designed to be used with the aScope™ Duodeno endoscope."
16408755|NCT04626505|Drug|Ziltivekimab|Administered subcutaneously (s.c., under skin) once every 4 weeks for 12 weeks
16408756|NCT04626505|Drug|Placebo (ziltivekimab)|Administered s.c. once every 4 weeks for 12 weeks
16408757|NCT04622254|Drug|NT 201|Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16408758|NCT04622254|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16408762|NCT04619472|Device|Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter|The conjunction of the pulmonary RFA system with the disposable pulmonary RFA catheter developed by Hangzhou Broncus Medical Co., Ltd. is aim to specifically target lung tumors. The ablation catheter is designed to reach the tumor through the bronchial pathway.
16408763|NCT04616560|Biological|Trastuzumab Deruxtecan|Given IV
16408764|NCT04616196|Drug|NKTR-255|After the loading dose of cetuximab, NKTR-255 IV, every 21 days with cetuximab weekly.
16408765|NCT04616196|Drug|NKTR-255|Cohort A will combine NKTR-255 and cetuximab in patients with R/R HNSCC and Cohort B will combine NKTR-255 and cetuximab in patients with R/R CRC. Each cycle of NKTR-255 will be 21 days, and cetuximab will be given weekly.
16408766|NCT04613596|Drug|MRTX849 Monotherapy|MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen (Cohort 1b).
16408767|NCT04613596|Drug|MRTX849 in Combination with Pembrolizumab|"MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen.
~Pembrolizumab is administered as an intravenous infusion once every 3 weeks (Cohort 2)."
16408768|NCT04613596|Drug|MRTX849 in Combination with Pembrolizumab|MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen. Pembrolizumab is administered as an intravenous infusion once every 3 weeks (Cohort 1a).
16408769|NCT04603365|Drug|Pamiparib|Given PO
16408770|NCT04603365|Drug|Temozolomide|Given PO
16408774|NCT04599556|Biological|anti-CD7 CAR-T|Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
16408775|NCT04596865|Procedure|Pancreaticoduodenectomy|Date of surgery 01/06/2010 - 31/05/2015
16408776|NCT04594239|Device|Belotero Balance (+) Lidocaine, needle|Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles
16408777|NCT04594239|Device|Belotero Balance (+) Lidocaine, cannula|Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas
16408778|NCT04594239|Device|Untreated-control / delayed-treatment, needle|Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)
16408779|NCT04594239|Device|Untreated-control / delayed-treatment, cannulas|Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)
16408780|NCT04594213|Drug|NT 201|Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16408781|NCT04594213|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16408782|NCT04593680|Drug|Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF)|The first full PK measurement of MHT will be performed starting at week 4 and end at week 6 to assess the steady-state plasma PK of testosterone in the absence of PrEP. The second PK measurement of MHT will be performed starting at week 12 and end at week 14 to assess plasma PK of testosterone in the presence of both MHT and PrEP. The first full PK measurement of PrEP will be performed at week 12 to assess the steady-state plasma PK of FTC, TFV, and TAF; and intracellular PBMC FTC-TP and TFV-DP in the presence of both MHT and PrEP. The second measurement of PrEP will be performed at week 16 to assess plasma PK of FTC, TFV, and TAF; and intracellular PBMC FTC-TP and TFV-DP in the absence of MHT.
16408783|NCT04590417|Drug|Estradiol valerate 2 mg, cyproterone acetate 25 mg|The entire study period will be approximately 1 year, which will include around 2 months of document preparation, 5 months of recruitment, 3 months of follow-up, and 2 months of data analysis.
16408784|NCT04586231|Drug|Belzutifan|Immediate-release 40 mg tablet
16408787|NCT04584892|Drug|Turoctocog alfa|Patients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
16408788|NCT04583787|Diagnostic Test|99mTc-sestamibi myocardial perfusion SPECT|82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1
16408789|NCT04583787|Diagnostic Test|82Rb-Chloride myocardial perfusion PET with CCTA|stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2
16408790|NCT04583280|Drug|Rilematovir|Participants of age group greater than or equal to (>=) 28 days to less than (<) 3 months (age group 1) or >= 3 months to < 6 months (age group 2) or >= 6 months to less than or equal to (<=) 5 years (age group 3) will receive rilematovir orally twice a day (BID) from Days 1 to Day 7 or Day 8.
16408791|NCT04583280|Drug|Rilematovir X mg/kg|Participants of age group birth at term (after at least 37 weeks of gestation) to < 28 days (age group 4) will receive rilematovir orally BID from Days 1 to Day 7 or Day 8. The dose is dependent on outcome of the substudy in neonates and following independent data monitoring (IDMC) review and recommendation.
16408792|NCT04583280|Drug|Placebo|Participant of age group 1, 2, 3 and 4 will receive matching placebo of rilematovir BID from Days 1 to Day 7 or Day 8 as per assigned age group.
16408793|NCT04582266|Drug|Remdesivir|RDV will not be provided as part of the study. Participants will be administered RDV intravenously once daily for up to 10 days per clinical care.
16408794|NCT04579666|Drug|Pegcetacoplan (APL-2)|Complement (C3) Inhibitor
16408795|NCT04579666|Other|Placebo|Sterile solution of equal volume to active arm
16408796|NCT04579224|Drug|Docetaxel|Given IV
16408797|NCT04579224|Drug|Eribulin Mesylate|Given IV
16408798|NCT04579224|Drug|Gemcitabine Hydrochloride|Given IV
16408799|NCT04579224|Drug|Paclitaxel|Given IV
16408800|NCT04574076|Drug|Turoctocog alfa pegol (N8-GP)|Patients will be treated with commercially available N8-GP for prophylaxis and treatment of bleeding episodes according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available N8-GP has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
16408801|NCT04571060|Drug|Zavegepant (BHV3500)|One dose of Zavegepant (BHV-3500)
16408802|NCT04571060|Drug|Placebo|One dose of matching placebo
16408803|NCT04570007|Procedure|Pars Plana Vitrectomy|removal of vitreous with vitreous cutter
16408805|NCT04567602|Drug|PAH medication|There will be no specific interventions.
16408806|NCT04567420|Drug|Palbociclib|4 week cycles
16408807|NCT04567420|Drug|Fulvestrant|4 week cycles
16408808|NCT04567420|Drug|Adjuvant Therapy|Standard of Care
16408811|NCT04565990|Drug|Selexipag|Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.
16408812|NCT04556526|Biological|Ad26.ZEBOV|Participants in Group A will receive 0.5 mL IM injection of Ad26.ZEBOV vaccine. Participants in Group B will receive Ad26.ZEBOV 6 weeks after delivery/termination of pregnancy.
16408813|NCT04556526|Biological|MVA-BN-Filo|Participants in Group A will receive 0.5 mL IM injection of MVA-BN-Filo vaccine. Participants in Group B will receive MVA-BN-Filo 6 weeks after delivery/termination of pregnancy.
16408814|NCT04555551|Biological|Infusion of MCARH109 T cells|Patients will be admitted to Memorial Hospital as inpatient prior to the infusion of CAR T cells. The T cell infusion will be planned to start at 2 days following the completion of the conditioning chemotherapy (up to 7 days is allowed if clinically indicated to delay).Cohorts of 3-6 patients each will be treated with escalating doses of modified T cells.
16408815|NCT04554212|Drug|Normal saline|A one time knee aspiration and saline injection will be performed at baseline visit.
16408816|NCT04554212|Device|Blood Flow Restriction Training|Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
16408817|NCT04554212|Other|Sham Injection|A one time sham knee aspiration with subcutaneous lidocaine will be performed at baseline visit.
16408818|NCT04554212|Device|Sham Blood Flow Restriction Training|Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
16408819|NCT04553068|Drug|EVO100|EVO100 vaginal gel
16408820|NCT04553068|Drug|Placebo|Placebo vaginal gel
16408821|NCT04549168|Drug|Lemborexant|Lemborexant 10 mg tablet.
16408822|NCT04549168|Drug|Placebo|Placebo tablet matched to lemborexant 10 mg tablet.
16408823|NCT04546087|Device|Ultrasound|Ultrasound scan of the cricothyroid membrane
16408824|NCT04540432|Other|Stool collection at the patient's home.|Stool samples will be taken from each patient to look for changes in intestinal microbiota. These collections will be made on Day 0 +24h, 24 hours before the 1st follow-up visit after 1 month of treatment with non-steroidal anti-inflammatory drugs, 24 hours after the second follow-up visit (between months 3 and 4) and finally, at the end of treatment.
16408825|NCT04540432|Diagnostic Test|Blood test|7 ml of blood will be taken from each patient before treatment i.e. at the inclusion visit and at the end of treatment.
16408826|NCT04537624|Drug|Oral Semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
16408827|NCT04535544|Drug|JNJ-73763989|JNJ-73763989 will be administered as a SC injection.
16408828|NCT04535544|Drug|Placebo|Matching placebo to JNJ-73763989 will be administered as a SC injection.
16408832|NCT04535453|Biological|Ad26.COV2.S|All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
16408833|NCT04535453|Other|Placebo|Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.
16408836|NCT04530565|Biological|Blinatumomab|Given IV
16408837|NCT04530565|Drug|Cyclophosphamide|Given IV
16408838|NCT04530565|Drug|Cytarabine|Given IV or IT
16408839|NCT04530565|Drug|Dasatinib|Given PO
16408840|NCT04530565|Drug|Dexamethasone|Given PO or IV
16408841|NCT04530565|Drug|Doxorubicin Hydrochloride|Given IV
16408842|NCT04530565|Drug|Mesna|Given IV
16408843|NCT04530565|Drug|Methotrexate|Given IV or IT
16408844|NCT04530565|Drug|Ponatinib Hydrochloride|Given PO
16408845|NCT04530565|Drug|Prednisone|Given PO
16408846|NCT04530565|Drug|Vincristine Sulfate|Given IV
16408847|NCT04530383|Drug|Metformin Hydrochloride|500-1000 mg twice daily
16408848|NCT04527991|Biological|Sacituzumab Govitecan-hziy|Administered intravenously
16408849|NCT04527991|Drug|Paclitaxel|Administered intravenously
16408850|NCT04527991|Drug|Docetaxel|Administered intravenously
16408851|NCT04527991|Drug|Vinflunine|Administered intravenously
16408852|NCT04526886|Other|Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy|Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy
16408853|NCT04524689|Drug|SAR408701 (Tusamitamab ravtansine)|Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
16408854|NCT04524689|Drug|Pembrolizumab|Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
16408855|NCT04524689|Drug|Cisplatin|Pharmaceutical form: Lyophilized powder for reconstitution in solution Route of administration: Intravenous
16408856|NCT04524689|Drug|Carboplatin|Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
16408857|NCT04524689|Drug|Pemetrexed|Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
16408862|NCT04519294|Device|SURE|The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.
16408863|NCT04519294|Device|Standard Ureteroscopy (Basketing)|This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.
16408864|NCT04518228|Drug|Bictegravir (BIC)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408865|NCT04518228|Drug|Tenofovir alafenamide (TAF)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408866|NCT04518228|Drug|Cabotegravir (CAB)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408867|NCT04518228|Drug|Dolutegravir (DTG)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408868|NCT04518228|Drug|Atazanavir/ritonavir (ATV/r)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408869|NCT04518228|Drug|Darunavir/ritonavir (DRV/r)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408870|NCT04518228|Drug|Lopinavir/ritonavir (LPV/r)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408871|NCT04518228|Drug|Cobicistat|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408872|NCT04518228|Drug|Ritonavir|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408873|NCT04518228|Drug|First-Line TB Treatment|"Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).
~Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants."
16408874|NCT04518228|Drug|Second-Line TB Treatment|"Participants will be receiving second-line TB treatment with at least one of the following second-line TB treatment drugs:
~Levofloxacin (LFX) 750mg - 1000mg q.d.
~Clofazimine (CFZ) 100mg q.d.
~Linezolid (LZD) 300mg - 600mg q.d.
~Bedaquiline (BDQ) 200mg three times per week (t.i.w.)
~Delamanid (DLM) 100mg b.i.d.
~Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
~Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants."
16408875|NCT04518228|Drug|Doravirine (DOR)|Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
16408876|NCT04516967|Drug|Avatrombopag|Oral avatrombopag Tablet
16408878|NCT04515771|Behavioral|PARTNER-MH|The study intervention consists of a peer navigation program developed by the study team. The navigation program focuses on navigating VA mental health services, as well as patient engagement in mental health services and patient-provider communication. The intervention will last for 6 months, during which the participant will commit to regularly meeting with their peer specialist (interventionist). Peer navigation sessions will be guided by the specific aims of the study program, but in a way that is tailored to the participants' specific needs.
16408879|NCT04515394|Drug|Tepotinib|Participants will receive Tepotinib initially at 500 milligrams (mg) once daily (QD) (2 film coated tablets of 250 mg QD). For potential dose de-escalation, the available 250 mg dose strength will be used (1 tablet once daily) until disease progression (according to Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1]), death, Adverse event (AE) leading to discontinuation, study withdrawal, or withdrawal of consent, whichever occurs first.
16408880|NCT04515394|Biological|Cetuximab|Cetuximab, is administered at an initial dose of 400 milligrams per square meter (mg/m^2) body surface area, over a recommended intravenous infusion period of 120 minutes and a maximum infusion rate of 5 milligrams per minute (5 mg/min), followed by or starting with weekly infusions at a dose of 250 mg/m^2 over a recommended infusion period of 60 minutes and a maximum infusion rate of 10 mg/min until disease progression, death, Adverse event (AE) leading to discontinuation of both study interventions, study withdrawal, or withdrawal of consent, whichever occurs first.
16408881|NCT04514302|Drug|Placebo|Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.
16408882|NCT04514302|Drug|Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)|INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
16408883|NCT04511052|Dietary Supplement|Probiotic|Daily intake of 10 x 10^9 CFU of a proprietary strain for a total duration of 10 weeks
16408884|NCT04511052|Other|Placebo|1 capsule daily containing the same carrier material that is similar in size, shape and taste to the probiotic, for a duration of 10 weeks
16408885|NCT04511052|Dietary Supplement|Carotenoid supplement|1 capsule daily containing ~20 mg of total carotenoids for a total duration of 10 weeks
16408886|NCT04509947|Biological|Ad26.COV2.S|Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
16408887|NCT04509947|Biological|Placebo|Placebo will be administered as IM injection.
16408888|NCT04508764|Other|Families Accelerating Cascade Testing Toolkit|-Online family history assessment, video of Siteman Cancer Center genetic counselors, physicians and patients highlighting the importance of cascade genetic testing, reviewing and receiving a family letter and gene information sheet, reviewing websites/online resources, and offering a family visit with a genetic counselor
16408889|NCT04508309|Biological|Cecolin®|Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine
16408890|NCT04508309|Biological|Gardasil®|Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine
16408891|NCT04507256|Combination Product|AZD7442|Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4.
16408892|NCT04507256|Other|Placebo|Participants randomised to placebo will receive the same volume of solution as participants on active treatment.
16408893|NCT04505722|Biological|Ad26.COV2.S|Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.
16408894|NCT04505722|Other|Placebo|Participants will receive Placebo.
16408895|NCT04492891|Drug|Cyclosporine|2.5 mg/kg PO BID 7 days
16408896|NCT04492891|Other|Standard of Care Treatment|Standard of Care Treatment, N= 25 Patients, 7 days
16408897|NCT04491942|Drug|Cisplatin|Given IV
16408898|NCT04491942|Drug|Elimusertib|Given PO
16408899|NCT04491942|Drug|Gemcitabine Hydrochloride|Given IV
16408900|NCT04484142|Drug|DS-1062a|DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks
16408901|NCT04482686|Drug|Ivermectin|Treatment days 1, 4, and 8
16408902|NCT04482686|Drug|Doxycycline Hcl|10 day treatment
16408903|NCT04482686|Dietary Supplement|Zinc|10 Day treatment
16408904|NCT04482686|Dietary Supplement|Vitamin D3|10 day treatment
16408905|NCT04482686|Dietary Supplement|Vitamin C|10 day treatment
16408906|NCT04481997|Other|Exposure to Anti-thrombotic treatment agents and glucose lowering therapy|Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
16408907|NCT04480736|Drug|Placebo|Matching placebo will be administered orally.
16408908|NCT04480736|Drug|JNJ-64281802 High dose|JNJ-64281802 high dose will be administered orally.
16408909|NCT04480736|Drug|JNJ-64281802 Medium dose|JNJ-64281802 medium dose will be administered orally.
16408910|NCT04480736|Drug|JNJ-64281802 Low dose|JNJ-64281802 low dose will be administered orally.
16408911|NCT04480736|Drug|JNJ-64281802 Dosing Regimen X|JNJ-64281802 dosing regimen X will be administered orally.
16408912|NCT04480736|Drug|JNJ-64281802 Dosing Regimen Y|JNJ-64281802 dosing regimen Y will be administered orally.
16408913|NCT04480736|Drug|JNJ-64281802 Dosing Regimen Z|JNJ-64281802 dosing regimen Z will be administered orally.
16408914|NCT04478734|Drug|Moderate doses of Thiamine y Biotin|Thiamine 600 mg every day + Biotin 150mg every day
16408915|NCT04478734|Drug|High doses of Thiamine y Biotin|Thiamine 1200 mg every day + Biotin 300mg every day
16408916|NCT04478071|Drug|vadadustat|Participants will receive vadadustat once daily for 14 days.
16408917|NCT04478071|Drug|placebo|Participants will receive matching placebo once daily for 14 days.
16408918|NCT04476043|Drug|INCB054707|Oral; Tablet
16408919|NCT04476043|Drug|Placebo|Oral; Tablet
16408920|NCT04472598|Drug|Navitoclax|Tablet; Oral
16408921|NCT04472598|Drug|Ruxolitinib|Tablet; Oral
16408922|NCT04472598|Drug|Placebo for Navitoclax|Tablet; Oral
16408923|NCT04468984|Drug|Navitoclax|Tablet; Oral
16408924|NCT04468984|Drug|Ruxolitinib|Tablet; Oral
16408925|NCT04468984|Drug|Best Available Therapy (BAT)|Tablet/Capsule; Oral or Solution for Subcutaneous Injection
16408928|NCT04462393|Other|Admission to ICU for COVID-19|All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020
16408929|NCT04460937|Drug|Adavosertib|Given PO
16408930|NCT04460937|Radiation|Radiation Therapy|Undergo radiation therapy
16408931|NCT04456023|Biological|Tisagenlecleucel|A single intravenous (i.v.) infusion of 0.6 - 6.0×10^8 CAR positive viable T cells.
16408932|NCT04455464|Drug|Midodrine Oral Tablet|Midodrine will be given 10 mg for one time only.
16408933|NCT04453007|Behavioral|e-checkup to go|The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
16408934|NCT04453007|Behavioral|Feedback booster|Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm.
16408935|NCT04452136|Drug|68GA PSMA-HBED-CC|Given IV
16408936|NCT04449913|Behavioral|10 days intensive meditation retreat|The intervention consists in a 10 days contemplative retreat, with 6 to 8 hours of sitting and walking meditation per day, and 1 or 2 hours of meditation teachings. The meditation practice will mainly train in mindfulness practice. Mindfulness meditation intends to train attention to detect and regulate afflictive cognitive and emotional patterns. Mindfulness practice requires skills involved in openness to experience, in monitoring the focus of attention and in detecting distraction, disengaging attention from the source of distraction, and flexibly (re)directing and engaging attention to the intended object. A brief introduction to loving-kindness and compassion meditation will also be present throughout the retreat.
16408937|NCT04449913|Behavioral|Waiting for a 10 days intensive meditation retreat|At the time of measure, participants in this group are waiting to participate to the same meditation retreat as the active group. They may perform their own daily meditation practices as usual.
16408938|NCT04449276|Biological|CVnCoV Vaccine|Participants will receive an intramuscular injection by needle in the deltoid area.
16408939|NCT04449276|Drug|Placebo|Participants will receive an intramuscular injection by needle in the deltoid area.
16408940|NCT04448301|Diagnostic Test|PointCheck|This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
16408941|NCT04446182|Drug|Itacitinib|All eligible patients will begin study therapy with approximately a week lead-in of itacitinib monotherapy at scheduled dose. Itacitinib will be taken daily at scheduled dose for a total of six cycles. itacitinib may be tapered as deemed appropriate by the treating investigator. Patients will remain on study therapy as long as treatment discontinuation criteria are not met.
16408942|NCT04446182|Device|Extracorporeal Photopheresis (ECP)|ECP will begin after itacitinib lead in period. ECP will be administered twice weekly on consecutive days for 8 weeks per institutional standards. At the end of 8 weeks of combination therapy, patients will start a standard ECP taper schedule.
16408946|NCT04442737|Drug|D/C/F/TAF FDC|A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
16408947|NCT04442737|Drug|TAF/FTC FDC|TAF/FTC ARV regimen will be administered once daily.
16408948|NCT04442737|Drug|INI Based Regimen|The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.
16408949|NCT04435782|Drug|JNJ-67896049|Participants will receive tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
16408950|NCT04435600|Drug|Risankizumab|Subcutaneous Injection
16408951|NCT04435600|Drug|Ustekinumab|Subcutaneous Injection
16408952|NCT04431635|Drug|Copanlisib|Copanlisib IV: day 1, 8, 15 every 28 days
16408953|NCT04431635|Drug|Nivolumab|Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only
16408954|NCT04431635|Drug|Rituximab|Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)
16408955|NCT04430985|Drug|Oxaliplatin|Day 1 in cycle 1-4: 100 mg/m2 intrahepatic administration Day 1 in cycle 5-8: oxaliplatin 85 mg/m2 i.v.
16408956|NCT04430985|Drug|5-Fluorouracil|Day 1 each cycle: 400 mg/m2 i.v. bolus, 2400 mg/m2 i.v.over 46 hrs
16408957|NCT04430985|Drug|Leucovorin|Day 1 each cycle: 400 mg/m2 i.v.
16408958|NCT04430985|Drug|Nivolumab|Day 3 in cycle 3 to 8: 3 mg/kg i.v.
16408959|NCT04430985|Device|Ipilimumab|Day 3 in cycle 3 and 6: 1 mg/kg i.v.
16408960|NCT04430348|Drug|PTX-35|Monoclonal antibody PTX-35
16408961|NCT04426825|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.
16408962|NCT04426825|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
16408963|NCT04425434|Other|OBSERVATIONAL|We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.
16408964|NCT04425421|Other|OBSERVATIONAL|OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE
16408965|NCT04424641|Biological|GEN1044 is an IgG1 bispecific antibody targeting CD3 and 5T4.|GEN1044 will be administered (intravenously) in cycles of 21 days. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.
16408966|NCT04424316|Biological|RSVpreF|RSV vaccine (RSVpreF)
16408967|NCT04424316|Biological|Placebo|Placebo
16408968|NCT04423796|Device|Robotic-assisted early mobilization|The early mobilization is done by robotic assistance devices.
16409467|NCT03557619|Drug|ethinyl estradiol/levonorgestrel|tablet; oral
16408969|NCT04423796|Other|Early mobilization|Early mobilization by health care professionals without robotic assistance.
16408970|NCT04423484|Other|Data collection|Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.
16408971|NCT04418765|Drug|Eptinezumab 100 mg|Eptinezumab 100 mg, concentrate for solution for infusion 100 mg/mL, intravenously
16408972|NCT04418765|Drug|Eptinezumab 300 mg|Eptinezumab 300 mg, concentrate for solution for infusion 100 mg/mL, intravenously
16408973|NCT04418765|Drug|Placebo|concentrate for solution for infusion, intravenously
16408974|NCT04417530|Drug|AU-011|AU-011 Via Suprachoroidal Administration with laser treatment
16408975|NCT04417530|Other|Sham Treatment|Sham treatment includes sham injection and sham laser
16408976|NCT04415086|Biological|convalescent plasma|The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.
16408977|NCT04413357|Other|Balanced Nutritional Drink|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
16408978|NCT04413357|Other|Diabetes Specific, Balanced Nutritional Drink (DMA)|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.
16408979|NCT04413357|Other|Diabetes Specific, Balanced Nutritional Drink DMB|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.
16408980|NCT04410796|Drug|Osimertinib|80mg orally daily
16408981|NCT04410796|Drug|Carboplatin|Carboplatin (AUC 5 IV q 3 weeks)
16408982|NCT04410796|Drug|Pemetrexed|Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles
16408983|NCT04410549|Diagnostic Test|Optical Coherence Tomography (OCT)|To perform OCT in pulmonary artery of patient with COVID-19
16408984|NCT04410523|Drug|CSJ117|CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
16408985|NCT04410523|Drug|Placebo|Placebo inhaled once daily for 16 weeks. Delivered via Concept1 device
16408986|NCT04410445|Biological|Bempegaldesleukin|Specified dose on specified days
16408987|NCT04410445|Biological|Nivolumab|Specified dose on specified days
16408989|NCT04401956|Other|bread|Different types of bread
16408990|NCT04400058|Biological|Octagam 10%|Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
16408991|NCT04400058|Other|Placebo|Placebo
16408996|NCT04396444|Combination Product|Aromastick|Vascular surgery patients will be randomized to either the intervention group and receive a lavender infused aromastick to use as an adjunct to their inpatient pain management plan, or to the control group, given a blank aromastick. Subjects will be blinded to their group.
16408997|NCT04394546|Device|WATCHMAN FLX LAAC Device|WATCHMAN FLX LAAC Device Implantation
16408998|NCT04394546|Drug|Non-Vitamin K Oral Anticoagulant|Initiation or continuation of a NOAC drug
16408999|NCT04390048|Device|Anodal tDCS|An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Anodal tDCS will deliver a low electrical current stimulation at 2 milliamps (mA). Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.
16409000|NCT04390048|Device|Sham tDCS|An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Sham tDCS will deliver a low electrical current stimulation at 2 mA and will be turned off 30 seconds following the application. Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.
16409001|NCT04390048|Other|BT|BT will be implemented 3 times a week over 4 weeks, each training session lasting about 20 minutes. BT will consist of the balance exercises with eyes open and closed.
16409002|NCT04387656|Procedure|Biospecimen Collection|Undergo collection of blood samples
16409003|NCT04387656|Other|Data Collection|Undergo collection of medical information and imaging
16409004|NCT04387656|Other|Quality-of-Life Assessment|Complete quality of life questionnaires
16409005|NCT04387656|Other|Questionnaire Administration|Complete quality of life questionnaires
16409006|NCT04381988|Drug|Hydroxychloroquine|400mg daily
16409007|NCT04381988|Other|Placebo|400mg daily
16409008|NCT04381988|Radiation|Radiation therapy|Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
16409015|NCT04368728|Biological|BNT162b1|Intramuscular injection
16409016|NCT04368728|Biological|BNT162b2|Intramuscular injection
16409017|NCT04368728|Other|Placebo|Intramuscular injection
16409018|NCT04368728|Biological|BNT162b2SA|Intramuscular injection
16409019|NCT04367311|Drug|Atezolizumab|Atezolizumab 1200 mg
16409020|NCT04367311|Drug|Docetaxel|Docetaxel 60-75 mg/m^2
16409021|NCT04367311|Drug|Cisplatin|60-75 mg/m^2
16409022|NCT04367311|Drug|Pemetrexed|Pemetrexed 500mg/m^2
16409023|NCT04357951|Drug|d-cycloserine|D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. It will be paired with 4 sessions of behavior therapy.
16409024|NCT04357951|Drug|Placebo pill|A pill placebo serves as an active comparator. It will be paired with 4 sessions of behavior therapy.
16409025|NCT04357951|Behavioral|Behavior Therapy|All participants will receive 4 sessions of behavior therapy for tics (e.g., habit reversal training, comprehensive behavioral intervention for tics).
16409026|NCT04357379|Behavioral|IQOS|Participants will try an IQOS product and then take home the IQOS to sample for one week.
16409027|NCT04340596|Biological|N-803 (IL-15 Superagonist)|Administered by subcutaneous (SQ) injection
16409028|NCT04340596|Biological|VRC07-523LS|Administered by intravenous (IV) infusion
16409029|NCT04340596|Biological|10-1074|Administered by intravenous (IV) infusion
16409031|NCT04336371|Diagnostic Test|Self-administered questionnaires|Self-administered questionnaires by the patient will be given during visits in the following order:the self-administered questionnaires concerning the announcement consultation will be completed by the patient after consultation waiting room; self-questionnaires will be given in just before the operation waiting room (D0) just before the suture removal points (J10) and just before the follow-up visit (M3).
16409034|NCT04334759|Drug|Durvalumab|Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
16409035|NCT04334759|Drug|Standard Chemotherapy|Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
16409036|NCT04330040|Drug|Olaparib|Tablet
16409037|NCT04323046|Biological|Ipilimumab|Given IV
16409038|NCT04323046|Biological|Nivolumab|Given IV
16409039|NCT04323046|Drug|Placebo Administration|Given IV
16409040|NCT04323046|Other|Quality-of-Life Assessment|Ancillary studies
16409041|NCT04323046|Other|Questionnaire Administration|Ancillary studies
16409042|NCT04317534|Drug|Pembrolizumab|Pembrolizumab 400mg IV
16409046|NCT04313712|Other|tabernanthe iboga exposure in other countries|Participants will be subject to MRI and mood/cognitive testing before and after exposure to tabernanthe iboga in other countries.
16409047|NCT04300556|Drug|MORAb-202|MORAb-202 intravenous infusion.
16409048|NCT04300556|Drug|Corticosteroid|Corticosteroid intravenous infusion.
16409049|NCT04300556|Drug|Corticosteroid|Corticosteroid orally.
16409050|NCT04299620|Device|Digital Image Analysis|Analysis of images
16409051|NCT04299620|Procedure|Radical Prostatectomy|Undergo standard of care radical prostatectomy
16409052|NCT04299620|Procedure|Transrectal Ultrasound|Undergo transrectal ultrasound
16409057|NCT04294654|Drug|Vortioxetine|Vortioxetine 5, 10 and 20 mg/day, tablets, orally Patients will receive 5 mg vortioxetine once daily for one week. At visit 3, the dose will be increased to 10 mg/day for all patients. Thereafter the dose may be adjusted to 5, 10 or 20 mg/day.
16409058|NCT04284605|Other|Aerobic exercise combined with strength training|30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.
16409059|NCT04284605|Other|Yoga|60 minute yoga intervention including different asanas, breath control and meditation
16409060|NCT04273945|Drug|Macitentan 10 mg|Participants will receive macitentan 10 mg film-coated tablets orally.
16409061|NCT04273945|Drug|Macitentan 37.5 mg|Participants will receive macitentan 37.5 mg film-coated tablets orally.
16409062|NCT04273945|Drug|Macitentan 75 mg|Participants will receive macitentan 75 mg film-coated tablets orally.
16409063|NCT04273945|Drug|Placebo|Participants will receive matching placebo film-coated tablets orally.
16409064|NCT04271683|Procedure|Pressure controlled ventilation with PEEP|The intervention consists of starting ventilation after apnoea during induction of general anesthesia with pressure controlled ventilation with PEEP instead of manually without PEEP.
16409172|NCT04064814|Drug|Flunarizine 5mg|Flunarizine 5mg once daily,orally for 12 weeks
16409065|NCT04271683|Procedure|Manual ventilation without PEEP|The intervention consists of starting ventilation after apnoea during induction of general anesthesia manually instead of with pressure controlled ventilation with PEEP.
16409066|NCT04271475|Drug|Macitentan|Participants will receive Macitentan film-coated tablets orally od.
16409067|NCT04271475|Drug|Placebo|Participant will receive matching placebo tablets orally od.
16409068|NCT04271254|Diagnostic Test|PET/MR|Patient will be scheduled for a pre-surgery PET/MR within four weeks of scheduled surgery.
16409069|NCT04267848|Drug|Carboplatin|Given IV
16409070|NCT04267848|Drug|Cisplatin|Given IV
16409071|NCT04267848|Drug|Gemcitabine Hydrochloride|Given IV
16409072|NCT04267848|Other|Observation|Undergo observation
16409073|NCT04267848|Drug|Paclitaxel|Given IV
16409074|NCT04267848|Biological|Pembrolizumab|Given IV
16409075|NCT04267848|Drug|Pemetrexed Disodium|Given IV
16409076|NCT04267848|Other|Quality-of-Life Assessment|Ancillary studies
16409077|NCT04267848|Other|Questionnaire Administration|Ancillary studies
16409078|NCT04262869|Drug|Carboplatin|Given IV
16409079|NCT04262869|Biological|Durvalumab|Given IV
16409080|NCT04262869|Drug|Paclitaxel|Given IV
16409081|NCT04262869|Drug|Pemetrexed|Given IV
16409082|NCT04259905|Behavioral|Active video game teleconference support group|12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device
16409083|NCT04259905|Behavioral|Standard support group + pedometer|3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
16409086|NCT04233398|Device|Device: Echopulse (HIFU ablation)|High-intensity focused ultrasound (HIFU) is a non-invasive, non-invasive treatment method. The principle is to focus high-intensity ultrasound on the target area. Energy is absorbed by the target tissue and converted into thermal energy. The local temperature quickly reaches a maximum of 85 ° C. It induces coagulative necrosis of focus tissue cells, but does not damage the tissues surrounding the treatment targ
16409087|NCT04231981|Drug|INCMGA0012|INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
16409088|NCT04230109|Drug|Sacituzumab Govitecan|Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
16409089|NCT04230109|Drug|Pembrolizumab|Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)
16409090|NCT04228783|Biological|Ad26.ZEBOV|Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
16409091|NCT04228783|Biological|MVA-BN-Filo|Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
16409092|NCT04228783|Biological|Placebo|Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
16409093|NCT04226352|Drug|Dextromethorphan|Dextromethorphan will be administered and its tolerability evaluated.
16409094|NCT04223960|Drug|EA1080|EA1080 Formulation A.
16409095|NCT04223960|Drug|EA1080|EA1080 Formulation B.
16409096|NCT04223960|Drug|EA1080|EA1080 Formulation C.
16409097|NCT04223960|Drug|EA1080|EA1080 Formulation D.
16409098|NCT04223960|Drug|EA1080-matching placebo|EA1080-matching placebo.
16409099|NCT04211909|Drug|SOF/VEL|400/100 mg FDC tablet orally once daily.
16409100|NCT04211909|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet orally once daily.
16409101|NCT04204408|Drug|NNC0365-3769 A (Mim8)|Mim8 administered subcutaneously (s.c., under the skin). The treatment period will consist of 12 once-weekly doses or 3 once-monthly doses
16409102|NCT04204408|Drug|Placebo (Mim8)|Mim8 placebo administered subcutaneously (s.c., under the skin)
16409103|NCT04200508|Other|Targeted gown and gloves use|Gown and glove use for high risk care activities in high risk residents
16409104|NCT04198922|Drug|Acalabrutinib|Given PO
16409105|NCT04198922|Other|Questionnaire Administration|Ancillary studies
16409106|NCT04197713|Drug|Adavosertib|Given PO
16409107|NCT04197713|Drug|Olaparib|Given PO
16409108|NCT04193046|Other|Blood Sample|Prevalent (existing) and incident (new) participants who are found to either have PH or not by RHC will provide blood sample for the establishment of a biomarker signature of PH.
16409109|NCT04189952|Drug|Acalabrutinib|Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
16409110|NCT04189952|Drug|Rituximab|Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
16409111|NCT04189952|Drug|Ifosfamide|Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
16409112|NCT04189952|Drug|Carboplatin|Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
16409113|NCT04189952|Drug|Etoposide|Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.
16409114|NCT04189614|Drug|Cofetuzumab Pelidotin|Intravenous (IV) infusion
16409115|NCT04188418|Drug|Fentanyl Citrate Buccal Tablet|Given transmucosally
16409116|NCT04188418|Drug|Morphine|Given PO
16409117|NCT04188418|Other|Physical Performance Testing|Complete shuttle walk test
16409118|NCT04188418|Other|Placebo Administration|Given PO
16409119|NCT04188418|Other|Quality-of-Life Assessment|Ancillary studies
16409120|NCT04188418|Other|Questionnaire Administration|Ancillary studies
16409121|NCT04182360|Drug|Carbetocin|Carbetocin administered intravenously, over 1 minute following delivery of the fetal head.
16409122|NCT04175600|Drug|Selexipag|Selexipag tablet will be administered orally.
16409123|NCT04175600|Drug|Placebo|Matching placebo tablets will be administered orally.
16409126|NCT04156659|Biological|Tisagenlecleucel|A single intravenous (i.v.) infusion of CAR-positive viable T cells.
16409127|NCT04151550|Device|Bilateral Laser Scleral Microporation procedure|"Device: Laser Scleral Microporation
~Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern."
16409128|NCT04151446|Device|Laser Scleral Microporation|Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.
16409129|NCT04147195|Drug|LYS006|Single treatment with LYS006
16409130|NCT04147195|Drug|LYS006 + Tropifexor (LJN452)|Combination treatment with LYS006 + Tropifexor (LJN452)
16409131|NCT04142398|Other|Cytology Specimen Collection Procedure|Undergo penile skin cell and anal swab collection
16409132|NCT04142398|Procedure|High Resolution Anoscopy with Biopsy|Undergo HRA with biopsy
16409133|NCT04142398|Other|Laboratory Biomarker Analysis|Correlative studies
16409134|NCT04142398|Procedure|Medical Examination|Undergo anal and penile clinical exam
16409135|NCT04142398|Procedure|Physical Examination|Undergo targeted physical exam
16409136|NCT04142398|Other|Questionnaire Administration|Ancillary studies
16409137|NCT04136756|Drug|NKTR-255|NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability
16409138|NCT04136756|Drug|NKTR-255 Q21|NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability
16409139|NCT04136756|Drug|Rituximab|Rituximab administered intravenously at specified dose on specified days
16409140|NCT04136756|Drug|Daratumumab|Daratumumab administered subcutaneously at specified dose on specified days
16409141|NCT04129554|Drug|JNJ-73763989|JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.
16409142|NCT04129554|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
16409143|NCT04129554|Drug|Placebo for JNJ-73763989|Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
16409144|NCT04129554|Drug|Placebo for JNJ-56136379|Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.
16409145|NCT04129554|Drug|Entecavir (ETV) monohydrate|ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
16409146|NCT04129554|Drug|Tenofovir disoproxil fumarate (TDF)|TDF will be administered orally once daily up to 48 weeks as NA treatment.
16409147|NCT04129554|Drug|Tenofovir alafenamide (TAF)|TAF will be administered orally once daily up to 48 weeks as NA treatment.
16409148|NCT04119050|Drug|M281|M281 injection administered as intravenous infusion
16409149|NCT04119050|Drug|Placebo|Placebo administered as intravenous infusion
16409150|NCT04118088|Biological|Darvadstrocel|Darvadstrocel suspension of human expanded adipose stem cells.
16409151|NCT04105062|Drug|LS301|-LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine
16409152|NCT04105062|Device|Cancer Vision Goggles|-Non-significant risk device
16409153|NCT04104451|Drug|Corlicyte|expanded umbilical cord lining mesenchymal stem cells
16409154|NCT04090918|Diagnostic Test|Cardiac examination programme 3 months after abdominal surgery|Blood- and urine sampling, electrocardiogram, wavECG (Myovista), transthoracic echocardiography, Finapres, cardiac magnetic resonance imaging
16409157|NCT04090411|Drug|50 mg|PF-06480605
16409158|NCT04090411|Drug|450 mg|PF-06480605
16409159|NCT04090411|Drug|150 mg|PF-06480605
16409160|NCT04090411|Other|0 mg|0 mg Placebo
16409161|NCT04088786|Drug|nanoliposomal irinotecan|The starting dose of nal-IRI will be 70 mg/m2 (cohort level 1) applied for 30 min using a closed HIPEC technique following completion of cytoreductive surgery. If there is dose limiting toxicity (DLT) in cohort level 1, then the dose will be reduced the dosage of the next cohort to 50 mg/m2 (cohort level 0). If there is no DLT, the dose of nal-IRI will be increased to 140 mg/m2, 210 mg/m2 and 280 mg/m2 . If one of the patients experiences DLT, then the cohort will expand to 6 patients and accrual to the current dose level and dose escalation will stop if 2 or more patients experience a DLT at a given dose level.
16409166|NCT04082429|Drug|Concizumab|When patients are randomised/allocated to concizumab prophylaxis, they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week (Wk) 0) (arm 2, 3 and 4) or visit 9a (Wk 24) (arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (Wk 6) or 9a.3 (Wk 30) and will be based on the concizumab exposure level measured at the previous visit 4a (Wk 6) or 9a.2 (Wk 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual replacement therapy until visit 9a (week 24; end of main part). In the extension part, patients in arm 1 will receive daily concizumab subcutaneous injections.
16409167|NCT04072887|Drug|QBW251|QBW251 b.i.d
16409168|NCT04072887|Drug|Placebo|Placebo b.i.d
16409169|NCT04070768|Drug|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 3mg/m^2, Days 1,4,7
16409170|NCT04070768|Drug|Venetoclax|Venetoclax, 100,200,400, or 600mg Daily Dose
16409171|NCT04067336|Drug|KO-539|Oral administration
16409173|NCT04064814|Drug|Alpha lipoic acid 300mg|Alpha lipoic acid 300mg ,once daily ,orally for 12 weeks
16409174|NCT04064346|Drug|Lixivaptan|Oral vasopressin 2 receptor antagonist
16409175|NCT04064346|Drug|Placebo|Matching placebo
16409176|NCT04058756|Drug|PDR001|PDR001
16409177|NCT04056611|Drug|JNJ-53718678 250 mg|JNJ-53718678 250 mg will be administered orally.
16409178|NCT04056611|Drug|Placebo|Matching placebo will be administered orally.
16409179|NCT04056611|Drug|JNJ-53718678 125 mg|JNJ-53718678 125 mg will be administered orally.
16409180|NCT04056520|Device|Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system|"The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
~Traumatic spinal fractures and/or traumatic dislocations.
~Instability or deformity.
~Failed previous fusions (e.g. pseudarthrosis).
~Tumors involving the cervical spine.
~Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/ or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability."
16409181|NCT04055103|Other|Monthly feedback, education and linking hospitals|- Give monthly feedback from LROI-data (revision rate & patient reported outcome measures) as well as other outcomes from the participating hospital (length-of-stay, readmission and complications), combined with education on how to use this information for improvement. This will be send monthly by email to the intervention group. Further, hospitals with worse performance for a certain outcome will be linked to hospitals with good performance for this outcome.
16409185|NCT04043143|Other|Arm 1 Prescription As Usual|At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.
16409186|NCT04043143|Other|Arm 2 Prescription Tool Intervention|The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
16409187|NCT04041583|Device|Cervical Interfacet Spacers|The use of Cervical Interfacet Spacers is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis [2]. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion [2].
16409188|NCT04039932|Behavioral|FLAME|The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.
16409189|NCT04039230|Drug|Talazoparib|Talazoparib belongs to a group of drugs called PARP inhibitors. PARP is a protein that is involved with repairing damaged DNA (the genetic material of cells). Talazoparib is believed to work by inhibiting (stopping) the PARP proteins from working in the cancer cells so that the cancer cannot fix its damaged DNA.
16409190|NCT04039230|Drug|Sacituzumab Govitecan|Sacituzumab govitecan is believed to work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent the cancer cells from growing/spreading.
16409191|NCT04033614|Device|Fasciotens-Abdomen|The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. A commercially available resorbable surgical mesh is sewn into the fascia margin. Commercial surgical sutures attached to this net are then attached to a height-adjustable suspension, which is connected to an external support on the thorax and pelvis. This ensures continuous traction to the two fascial edges. The remaining wound surface can then be treated with conventional dressing material.
16409192|NCT04013529|Behavioral|Regret lottery|Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
16409193|NCT04013529|Behavioral|Way to Health technology enhanced care|Subjects receive text reminders to reach activity goals.
16409194|NCT04012931|Drug|Rilpivirine|Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.
16409195|NCT04012931|Drug|ARV Background Regimen|The investigator-selected ARVs, including but not limited to N(t)RTIs (example, azidothymidine [AZT], abacavir [ABC], tenofovir alafenamide [TAF], or tenofovir disoproxil fumarate [TDF] in combination with emtricitabine [FTC] or lamivudine [3TC]), whichever are approved and marketed or considered local standard of care for children aged between 2 and < 12 years in a particular country are to be administered. Integrase inhibitors (for example, dolutegravir [DTG] or raltegravir) can also be administered in combination with RPV, as appropriate.
16409196|NCT04011358|Other|Sleeping Monitor|to evaluate obstructive sleep apnea
16409197|NCT04003779|Other|Room configuration|Adjust distance, handrails, degrees of turn for participant
16409198|NCT04000880|Behavioral|Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health|AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
16409199|NCT04000880|Other|Diet-Exercise|Diet-Exercise
16409200|NCT04000880|Other|Exercise-Diet|Exercise-Diet
16409201|NCT04000880|Other|Survivorship Topics - Combined Diet and Exercise|Survivorship Topics - Combined Diet and Exercise
16409202|NCT03998735|Drug|Herbal Snuff (Smokeless Tobacco)|4 levels of [D4]nornicotine in herbal snuff
16409203|NCT03989440|Drug|AXER-204|human NoGo Trap fusion protein
16409204|NCT03989440|Drug|Placebo|Phosphate buffered saline formulation
16409302|NCT03885596|Drug|Lidocaine HCl|1.5% 12 mL at the end of surgery
16409205|NCT03982199|Biological|RSV Vaccine|Participants will receive a single IM injection of an Ad26-based RSV vaccine at a single dose level on Day 1 and revaccination after either 1 year, 2 years, 3 years or 4 years.
16409206|NCT03982199|Biological|Placebo|Participants will receive a single IM injection of placebo control on Day 1.
16409207|NCT03982186|Drug|JNJ-73763989|JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.
16409208|NCT03982186|Drug|Placebo for JNJ-73763989|Placebo for JNJ-73763989 will be administered as subcutaneous injection.
16409209|NCT03982186|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally.
16409210|NCT03982186|Drug|Placebo for JNJ-56136379|Placebo for JNJ-56136379 tablets will be administered orally.
16409211|NCT03982186|Drug|Nucleos(t)ide Analog (NA)|NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
16409212|NCT03981952|Biological|Trivalent Invasive Salmonella Disease Vaccine (6.25 µg)|6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
16409213|NCT03981952|Biological|Trivalent Invasive Salmonella Disease Vaccine (12 µg)|12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
16409214|NCT03981952|Biological|Trivalent Invasive Salmonella Disease Vaccine (25 µg)|25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
16409215|NCT03981952|Biological|Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C)|The highest, well-tolerated dose of the conjugate vaccine among Cohorts A-C is administered via one or two intramuscular injection(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).
16409216|NCT03981952|Other|Placebo|0.5 mL of buffer and preservative is administered via one or two intramuscular injections(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).
16409217|NCT03979430|Other|Home spirometry|Patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth. Data will be transferred to a webpage, which team members have access to. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year. Patients will also conduct a survey to measure health related quality of life (K-BILD). This questionnaire, as well as a phone interview to record changes in medication and condition will be conducted at baseline and every 4 weeks. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and urine samples will be collected and analyzed.
16409218|NCT03975647|Drug|tucatinib|300mg given twice per day by mouth (orally)
16409219|NCT03975647|Drug|placebo|Given twice per day orally
16409220|NCT03975647|Drug|T-DM1|3.6 mg/kg given into the vein (IV; intravenously) every 21 days
16409221|NCT03969888|Drug|ABBV-3067|Tablet or capsule taken orally
16409222|NCT03969888|Drug|Placebo ABBV-3067|Tablet or capsule taken orally
16409223|NCT03969888|Drug|ABBV-2222|Capsule taken orally
16409224|NCT03969888|Drug|Placebo ABBV-2222|Capsule taken orally
16409225|NCT03968939|Drug|Diphenhydramine (Benadryl)|Oral Diphenhydramine (Benadryl), 25 mg
16409226|NCT03968939|Dietary Supplement|Melatonin|Oral Melatonin, 3 mg
16409227|NCT03968939|Behavioral|Sleep Hygiene Education|"Brochure containing information about getting a good night's sleep."
16409228|NCT03959891|Drug|Ipatasertib|Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt.
16409229|NCT03959891|Drug|Fulvestrant|Hormone therapies work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell.
16409230|NCT03959891|Drug|Aromatase Inhibitor|Letrozole is an aromatase inhibitor. This means it blocks the enzyme aromatase (found in the body's muscle, skin, breast and fat), which is used to convert androgens (hormones produced by the adrenal glands) into estrogen. In the absence of estrogen, tumors dependent on this hormone for growth will shrink.
16409231|NCT03959891|Drug|Palbociclib|Palbociclib (Ibrance®) is a drug that can be used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer. Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor. The drug blocks proteins in the cell called cyclin-dependent kinase (CDK) 4 and CDK 6. In hormone positive breast cancer cells, blocking these proteins helps stop the cells from dividing to make new cells. It helps prevent the cells from moving from G1 to S cell cycle phase in the division process. This slows cancer growth.
16409232|NCT03950609|Drug|Everolimus|Given PO
16409233|NCT03950609|Drug|Lenvatinib|Given PO
16409234|NCT03943875|Biological|9-valent HPV vaccine, 2 dose efficacy|Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
16409235|NCT03943875|Biological|9-valent HPV vaccine, 3 doses standard timing|Will be comparison group for 2 dose efficacy group.
16409236|NCT03942653|Drug|Goserelin Acetate|Goserelin Acetate, SQ, Q4W
16409237|NCT03942653|Drug|Pembrolizumab|Pembrolizumab, IV, Q3W
16409238|NCT03942627|Behavioral|Mindfulness Program|The intervention consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of mindfulness practices delivered via audio recordings to assist mothers in managing stress during the NICU stay and another series for the transition home.
16409239|NCT03942627|Behavioral|Infant Health Education Program|The active control condition consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of audio recordings providing information on infant health and development for mothers to use during the NICU stay and another series for the transition home.
16409240|NCT03942211|Drug|Selexipag|Oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 (200 µg) to 8 (1600 µg) tablets at each administration
16409241|NCT03942211|Drug|Placebo|Oral tablets without active compound. Participants can receive 1 to 8 tablets at each administration.
16409303|NCT03885596|Drug|Celecoxib|200 mg PO bid each day postoperative
16409242|NCT03938350|Behavioral|Dialectical Behavior Therapy (DBT) Skills Training|Standard DBT skills training is a comprehensive intervention for emotion dysregulation that includes four skills modules: (1) mindfulness skills; (2) emotion regulation skills; (3) interpersonal effectiveness skills; and (4) distress tolerance skills designed to target adaptive skills deficits that define emotion dysregulation. The sessions will be delivered virtually via a HIPAA-compliant video platform.
16409268|NCT03912350|Drug|Balovaptan|Participants will receive 1 tablet of balovaptan once daily (QD) on Days 1 through 14.
16409269|NCT03910621|Drug|Miglustat|capsule, oral use
16409270|NCT03910413|Diagnostic Test|Duel Energy CT|Enrolled subjects will complete a dual energy ct for evaluation of esophageal varices
16409271|NCT03907488|Drug|Brentuximab Vedotin|Given IV
16409272|NCT03907488|Drug|Dacarbazine|Given IV
16409273|NCT03907488|Drug|Doxorubicin Hydrochloride|Given IV
16409274|NCT03907488|Biological|Filgrastim|Given SC or IV
16409275|NCT03907488|Biological|Nivolumab|Given IV
16409276|NCT03907488|Biological|Pegfilgrastim|Given SC
16409277|NCT03907488|Other|Quality-of-Life Assessment|Ancillary studies
16409278|NCT03907488|Other|Questionnaire Administration|Ancillary studies
16409279|NCT03907488|Radiation|Radiation Therapy|Receive radiation therapy
16409280|NCT03907488|Drug|Vinblastine Sulfate|Given IV
16409281|NCT03904693|Drug|FDC macitentan/tadalafil|Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.
16409282|NCT03904693|Drug|Macitentan 10 mg|Film-coated tablet with 10 mg macitentan, to be administered orally once daily.
16409283|NCT03904693|Drug|Tadalafil 40 mg|Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.
16409284|NCT03904693|Drug|Placebo FDC|Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
16409285|NCT03904693|Drug|Placebo macitentan|Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
16409286|NCT03904693|Drug|Placebo tadalafil|Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
16409287|NCT03897348|Drug|Placebo|Oral medication
16409288|NCT03897348|Drug|Lacosamide 100 mg|Oral medication
16409289|NCT03897348|Drug|Lacosamide 200 mg|Oral medication
16409295|NCT03888560|Device|Micro-osteoperforations|MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites
16409297|NCT03885596|Drug|CA-008|Drug: CA-008 4.2 mg reconstituted in saline
16409298|NCT03885596|Drug|Ketorolac|30 mg IV at the onset of anesthesia
16409299|NCT03885596|Drug|Acetaminophen IV|1 g at the onset of anesthesia
16409300|NCT03885596|Drug|Fentanyl|100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
16409301|NCT03885596|Drug|Bupivacaine Hydrochloride|0.25% 30 mL (75 mg) prior to surgery
16409305|NCT03885596|Drug|Lidocaine Hydrochloride|2% 15 mL at the end of surgery
16409306|NCT03885596|Drug|Exparel|Bupivacaine liposome injection suspension
16409307|NCT03878823|Drug|ODM-209|co-administered with glucocorticoid and mineralocorticoid, orally daily
16409308|NCT03878316|Drug|Instranasal Oxytocin|Intranasal Oxytocin - concentrated formulation - 20U per pump
16409309|NCT03876483|Behavioral|Virtual peer support group|Intervention package will consist of a WhatsApp group setup and organized by the study. Participants will be divided into 1-3 WhatsApp groups, each with 10-55 youth. Each group will be facilitated by a study staff member trained as a counselor. The facilitator will send weekly messages to the group. Messages from the facilitator will not contain overtly HIV-related language. These messages are intended to spark unstructured discussion among study participants, or with the facilitator, at any time through the WhatsApp group or individually. Subsequent messages from the study will answer participant questions or correct misinformation. Standard operating procedures (SOPs) will be developed for standardizing responses to the questions received so that study staff follow national guidelines and local practice standards to respond.
16409310|NCT03871257|Drug|Carboplatin|Given IV
16409311|NCT03871257|Other|Quality-of-Life Assessment|Ancillary studies
16409312|NCT03871257|Other|Questionnaire Administration|Ancillary studies
16409313|NCT03871257|Drug|Selumetinib Sulfate|Given PO
16409314|NCT03871257|Drug|Vincristine Sulfate|Given IV or IV push
16409315|NCT03869190|Drug|Atezolizumab|"For the control, + EV, + Nira, + Tira, and + SG arms, + RO7122290, Atezolizumab will be administered intravenously (IV) at a fixed dose of 1200 mg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
~For the Atezo + Hu5F9-G4 and + TCZ arms, Atezo will be administered IV at a fixed dose of 840 mg every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle."
16409316|NCT03869190|Drug|Enfortumab Vedotin|Enfortumab vedotin will be administered at a dose of 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle.
16409317|NCT03869190|Drug|Niraparib|Niraparib will be administered at a dose of 200 mg once daily (QD) by mouth.
16409318|NCT03869190|Drug|Hu5F9-G4|Participants will receive an 1-mg/kg priming dose IV on Day 1 followed by three weekly IV doses of 30 mg/kg on Days 8, 15, and 22. During Cycle 2, participants will receive weekly IV doses of 30 mg/kg on Days 1, 8, 15, and 22. For all subsequent cycles, participants will receive 30 mg/kg on Days 1 and 15. Cycle = 28 days.
16409319|NCT03869190|Drug|Tiragolumab|Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21-day cycle.
16409320|NCT03869190|Drug|Sacituzumab Govitecan|Sacituzumab Govitecan will be administered at a dose of 10 mg/kg by IV on Day 1 and 8 of each 21-day cycle.
16409321|NCT03869190|Drug|Tocilizumab|Tocilizumab will be administered by IV infusion at a dose of 8 mg/kg every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
16409322|NCT03869190|Drug|RO7122290|RO7122290 will be administered by IV infusion at a dose of 250 mg on Day 1, 8, and 15 of each 21-day cycle.
16409323|NCT03869190|Drug|RO7121661|RO7121661 will be administered by IV infusion at a dose of 2100 mg on Day 1 and 15 of each 21-day cycle.
16409324|NCT03866538|Drug|Withdrawal of Oral Budesonide|The intervention arm will taper and stop budesonide therapy (withdrawal).
16409325|NCT03861702|Drug|FOLFOX regimen|FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)
16409326|NCT03861702|Drug|Liposomal Irinotecan|Liposomal Irinotecan
16409327|NCT03856619|Drug|TERIFLUNOMIDE HMR1726|"Pharmaceutical form: Tablet
~Route of administration: Oral"
16409328|NCT03852524|Drug|Methylnaltrexone|Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
16409329|NCT03852524|Other|Placebo|Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
16409330|NCT03851796|Behavioral|TEENS+Parents as Coaches|Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.
16409331|NCT03851796|Behavioral|TEENS+Parent Weight Loss|Parent Weight loss teaches core behavioral weight loss strategies and techniques for parent weight loss; adolescents are in a group based behavioral weight management treatment.
16409332|NCT03851133|Other|Blood Sample Collection|Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date) and at the time of follow-up (approximately 6 months and approximately 12 months after baseline).
16409333|NCT03851133|Other|Tumor Sample collection|At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.
16409334|NCT03851133|Other|Data Collection|Participants will be asked to complete a 3 page screening tool at the time of their in-person clinic visit, as well as questionnaires at baseline and at 6 and 12 months.
16409335|NCT03848845|Drug|belantamab mafodotin|belantamab mafodotin will be available as 20 milligrams per millilitre (mg/mL) solution for IV infusion, supplied as frozen liquid. belantamab mafodotin solution will be diluted in normal 0.9% saline to the appropriate concentration for the dose.
16409336|NCT03848845|Drug|Pembrolizumab|Pembrolizumab will be available as 100 mg/4 mL solution that should be stored under refrigeration at 2-8 degree Celsius. Pembrolizumab injection (solution) will be diluted prior to IV administration in 0.9% sodium chloride injection or 5% dextrose injection.
16409337|NCT03842982|Drug|HIPEC|"HIPEC protocol (ONLY Arm A) consisted in cisplatin 100mg/m2 intraperitoneally (IP), heated to 40°C for 90 minutes, along with an IV perfusion of sodium thiosulfate.
~Administration of the dose should be according the following schedule:
~50% of the dose at start of perfusion, 25% of the dose after 30 minutes from start of the perfusion and 25% of the dose after 60 minutes from start of the perfusion.
~The procedure takes 120 minutes with a 90-minute perfusion period. The IV perfusion of sodium thiosulfate is for renal protection. At the start of HIPEC procedure, 9 g/m2 in 200 ml of distilled water will be administered by IV over 15 to 30 minutes. It will be then followed by 12 g/m2 in 1 liter (1L) distilled water in a continuous IV for 6 hours."
16409338|NCT03842189|Drug|M281|Participants will receive once weekly intravenous (IV) infusions of M281
16409391|NCT03760627|Behavioral|Mindfulness Resiliency Training|The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
16409339|NCT03838120|Other|Procedure/Surgery: bupivakain % 0,5|In this study, 5 patients were included in each volume group and at least 3 applications out of 5 had to be successful to consider the volume to be sufficient. After a successful group, the volume was reduced by 2 ml's and the same procedure was followed until a final group with unsuccessful anesthesia was found (≤2 successful blockades). The study was ended at this point and MEV was determined as the volume used in the last successful group. The researcher which determined the success of blockade was blinded to the study protocol. BMI, ASA Score, Successful blockade onset time Regression time of sensorial blockade Regression time of motor blockade Time of first additional analgesic requirement
16409340|NCT03831360|Behavioral|Yoga|Hatha yoga for depressed adolescents
16409341|NCT03831360|Behavioral|Group CBT|Group cognitive behavioral therapy for depressed adolescents
16409342|NCT03829228|Dietary Supplement|Proglucamune|Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).
16409349|NCT03821272|Biological|PepCan|50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
16409350|NCT03821272|Biological|Placebo|0.9% Saline solution per dose administered intradermally in the extremities
16409351|NCT03821038|Biological|CYT107|IV twice a week at 10µg/kg for 3 weeks
16409352|NCT03821038|Drug|Placebos|IV twice a week at the same volume for 3 weeks
16409353|NCT03818360|Behavioral|an evidence-based smoking cessation intervention comprising brief advice plus active referrals|The trained healthcare professionals will be encouraged to deliver brief smoking cessation advice based on the AWARD model to smokers who attend emergency departments and are triaged as semi-urgent or non-urgent. The trained healthcare professionals will ask the smokers their smoking history, then deliver the warning message to the smokers. If the smokers refuse to quit immediately, the trained healthcare professionals will advise them to reduce the number of cigarettes smoked per day, with the goal of complete cessation within 6 months. The healthcare professionals will then actively refer smokers to the chosen service provider within 1 week of recruitment. Smokers will receive proactive telephone calls from the service providers, receive a leaflet about the health-related hazards of smoking and benefits of quitting, and a pocket-sized information card containing brief information about the existing smoking cessation services in Hong Kong.
16409354|NCT03816358|Biological|Anetumab Ravtansine|Given IV
16409355|NCT03816358|Drug|Gemcitabine Hydrochloride|Given IV
16409356|NCT03816358|Biological|Ipilimumab|Given IV
16409357|NCT03816358|Biological|Nivolumab|Given IV
16409358|NCT03812471|Device|3D volume acquisitions|2 abdominal volumes 2 thigh volumes 2 head volumes
16409359|NCT03812471|Device|2D standard measurements and 3D volumes acquisitions|"1 abdomen circumference measurement
~1 femur length measurement
~1 head circumference measurement
~1 bi-parietal diameter measurement
~1 abdominal volume
~1 thigh volume
~1 head volume"
16409360|NCT03812302|Diagnostic Test|68-Ga HA-DOTATATE PET/CT|See arm description.
16409369|NCT03806803|Biological|Lyophilized fecal microbiota transplant|15 capsules
16409370|NCT03806803|Biological|Lyophilized sterile fecal filtrate|15 capsules
16409371|NCT03806309|Drug|FOLFIRI|Intravenous (IV); folinic acid 400 mg/m^2, irinotecan 180 mg/m^2, 5-FU bolus 400 mg/m^2 and continuous infusion 2,400 mg/m^2
16409372|NCT03806309|Drug|OSE2101|subcutaneous injection on days 1 and 15, every 4 weeks for 6 doses then every 8 weeks until month 12 and then every 12 weeks for a maximum treatment duration of 24 months
16409378|NCT03785925|Biological|Bempegaldesleukin|Specified dose on specified days
16409379|NCT03785925|Biological|Nivolumab|Specified dose on specified days
16409380|NCT03782532|Drug|Dupilumab SAR231893|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
16409381|NCT03782532|Drug|Placebo|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
16409382|NCT03782532|Drug|Asthma Controller Therapies (include prednisone/prednisolone)|"Pharmaceutical form: Aerosol, capsules, tablets, oral solution
~Route of administration: Inhalation, oral"
16409383|NCT03782532|Drug|Asthma Reliever Therapies|"Pharmaceutical form: Nebulized, aerosol
~Route of administration: Inhaled"
16409384|NCT03775421|Drug|macitentan 10 mg|macitentan 10 mg, film-coated tablet, oral use
16409385|NCT03772873|Procedure|minimally invasive pilonidal excision|MIPE procedure with trephine excision of pits and sinuses
16409386|NCT03772587|Drug|M281|M281 administered as IV infusion
16409387|NCT03772587|Other|Placebo|Placebo administered as intravenous (IV) infusion
16409388|NCT03761849|Drug|RO7234292|Intrathecal injection
16409389|NCT03761849|Drug|Placebo|Intrathecal injection
16409390|NCT03760627|Behavioral|Refugees Mindfulness Resiliency Training|The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
16409509|NCT03444701|Drug|E7130|Starting dose of 25 μg/m^2 on Day 1 and Day 15 of Cycle 1.
16409392|NCT03745924|Drug|Nonacog beta pegol|Participants are treated with commercially available nonacog beta pegol (N9-GP) according to local clinical practice at the discretion of the treating physician
16409393|NCT03739931|Biological|mRNA-2752|Solution for intratumoral injection
16409394|NCT03739931|Biological|Durvalumab|Solution for infusion after dilution
16409397|NCT03718520|Other|no intervention, this is a purely observational study|No intervention
16409398|NCT03714815|Drug|macitentan 10 mg|macitentan 10 mg, film-coated tablet, oral use
16409399|NCT03714516|Behavioral|Psychological internet intervention|The intervention is a non-controlled unguided internet-based self-help intervention for adults who seek support for coping with prolonged grief symptoms after romantic bereavement or separation/ divorce. The self-help program consists of 10 text-based sessions based on cognitive-behavioral psychotherapy techniques.
16409400|NCT03713398|Behavioral|T4C-SMI|T4C-SMI entails a 25-session, manualized intervention that is delivered in a closed-group format at least twice a week over a three-month period. The intervention curriculum includes three modules: nine sessions on social skills training, five sessions on cognitive restructuring activities, and ten sessions on problem-solving methods. Participants assigned to T4C-SMI receive this intervention in addition to any other prison mental health services that they are otherwise eligible to receive during their incarceration.
16409406|NCT03680131|Drug|EB01 Cream Placebo|Vehicle Cream containing 0% EB w/w applied BID
16409407|NCT03680131|Drug|EB01 Cream 0.2%|EB01 Cream containing 0.2% EB01 w/w applied BID
16409408|NCT03680131|Drug|EB01 Cream 1.0%|EB01 Cream containing 1.0% EB01 w/w applied BID
16409409|NCT03680131|Drug|EB01 Cream 2.0%|EB01 Cream containing 2.0% EB01 w/w applied BID
16409410|NCT03664804|Other|No Study Drug was Administered in this Study|No study drug was administered in this study
16409416|NCT03656510|Drug|JNJ-53718678|Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.
16409417|NCT03656510|Drug|Placebo|Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.
16409418|NCT03636165|Drug|Methylprednisolone|The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.
16409419|NCT03636165|Drug|Ropivacaine|The local infiltration solution containing 2mg Ropivacaine per milliliter.
16409420|NCT03635151|Behavioral|Telephone Assessment and Skill-Building Kit (TASK III) Group|The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.
16409421|NCT03635151|Behavioral|Information Support and Referral (ISR) Group|The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
16409422|NCT03607994|Device|HIRREM-SOP|HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
16409423|NCT03607994|Device|NCC|Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
16409424|NCT03607695|Other|Gait training|Walking on a treadmill and receiving audio cues to improve gait
16409425|NCT03606512|Biological|Ad26.RSV.preF|Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
16409426|NCT03606512|Biological|Placebo|Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
16409427|NCT03606512|Biological|Nimenrix|Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
16409428|NCT03605667|Drug|troriluzole|Oral BHV-4157 will be given daily for up to 48 weeks
16409429|NCT03605667|Drug|Placebo oral capsule|Oral matching placebo will be given daily for up to 48 weeks
16409430|NCT03598257|Drug|Olaparib|Given PO
16409431|NCT03598257|Radiation|Radiation Therapy|Undergo radiation therapy
16409432|NCT03597347|Drug|Molgramostim nebulizer solution|300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
16409433|NCT03597347|Device|PARI eFlow nebulizer system|PARI eFlow nebulizer system
16409434|NCT03590041|Behavioral|Standardized SMA|Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.
16409463|NCT03560466|Drug|Dupilumab (SAR231893/REGN668)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous (sc)"
16409464|NCT03560466|Drug|Asthma controller therapies (incl. prednisone/prednisolone)|"Pharmaceutical form: powder, or solution, or pill
~Route of administration: inhaled, oral or parenteral"
16409465|NCT03560466|Drug|Asthma reliever therapies|"Pharmaceutical form: powder or solution
~Route of administration: inhaled"
16409435|NCT03590041|Behavioral|Patient-driven SMA|Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
16409436|NCT03589300|Device|Persona TM Tibia|Trabecular Metal tibia used in primary cementless total knee arthroplasty
16409437|NCT03583333|Drug|IMI/REL FDC|500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial
16409438|NCT03583333|Drug|PIP/TAZ FDC|4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial
16409439|NCT03583333|Drug|Linezolid|Open-label 600 mg Linezolid
16409443|NCT03580044|Combination Product|ATM-AVI|ATM-AVI doses (loading, extended loading and maintenance) and the dosing frequency of the maintenance dose are dependent on renal function. Subjects will be given a loading dose of 500 mg ATM plus 167 mg AVI or 675 mg ATM plus 225 mg AVI over a period of 30 minutes. This treatment will immediately be followed by an extended loading dose of 1500 mg ATM plus 500 mg AVI or 675 mg ATM plus 225 mg AVI over a period of 3 hours. Then there will be a 3 hour or 5 hour gap. Subjects will receive a maintenance dose of 1500 mg ATM plus 500 mg AVI every 6 hours or 750 mg ATM plus 250 mg AVI every 6 hours, or 675 mg ATM plus 225 mg AVI every 8 hours. Subjects with cIAI will also receive Metronidazole (MTZ) 500 mg IV q8h over 60 minutes. The first dose of MTZ will be started immediately after the extended loading dose of ATM-AVI has completed and treatment will be continued until the end of the treatment period.
16409444|NCT03580044|Drug|BAT|The comparator treatments in this study are to be the best available therapy (BAT) based upon site practice and local epidemiology. The choice of BAT for each subject must be recorded prior to randomization. Acceptable BAT may include but not limit to the following Aminoglycoside; Colistin (or polymixin B if colistin not available/accessible); Fosfomycin; Meropenem; Tigecycline. If the chosen BAT does not provide adequate anaerobic coverage for cIAI subjects MTZ is to be administered as a co therapy. BAT dose, frequency, dose adjustments with renal impairment will be based on per local package inserts.
16409445|NCT03579667|Behavioral|Diet intervention|12-week program of dietary behavior modification treatment (LEVA-method by Bertz et al, Am J Clin Nutr 2012;96:698.), leading to 6 kg weight loss (0.5 kg per week) and a healthier diet (less sugar, snacks, full fat products, more vegetables and fruit, smaller portion sizes). Weight is monitored by phone contact every second week. After 12 weeks, the women are followed up by e-mail contact for 9 additional months.
16409448|NCT03574571|Drug|Docetaxel 75 mg/m2|Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
16409449|NCT03574571|Drug|Docetaxel 60 mg/m2|Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
16409450|NCT03574571|Drug|Radium-223|Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
16409451|NCT03573856|Behavioral|Active Living|Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
16409452|NCT03573856|Other|Health and Safety|Participants will be provided with education related to general health and safety topics.
16409453|NCT03566043|Genetic|RGX-121|Recombinant adeno-associated virus serotype 9 capsid containing human iduronate-2-sulfatase expression cassette
16409454|NCT03565445|Drug|ASP1948|Intravenously (IV)
16409455|NCT03565445|Drug|nivolumab|Intravenously (IV)
16409456|NCT03565445|Drug|pembrolizumab|Intravenously (IV)
16409457|NCT03564873|Drug|Omacetaxine|Phase I is a dose escalation phase. Patients will be enrolled into one of three cohorts to receive omacetaxine subcutaneously (0.5, 0.75, 1.0, or 1.25 mg/m2) twice daily on days 1 to 7.
16409458|NCT03564873|Drug|Azacitidine|Azacitidine will be given at the standard dose and schedule, 75 mg/m2 once daily, on days 1 to 7. The patients will then be monitored for 21 more days ( to complete one 28 day cycle) but no more medication will be administered during those 21 days.
16409459|NCT03564873|Drug|Omacetaxine|Phase II is a maximum tolerated dose phase. Phase I will determine the maximum tolerated dose (highest amount that can be safely administered). Patients will receive omacetaxine subcutaneously at the maximum tolerated dose (0.5, 0.75, 1.0, or 1.25 mg/m2) twice daily on days 1 to 7.
16409460|NCT03564873|Drug|Azacitidine|Azacitidine will be given at the standard dose and schedule, 75 mg/m2 once daily, on days 1 to 7. The patients will then be monitored for 21 more days ( to complete one 28 day cycle) but no more medication will be administered during those 21 days.
16409461|NCT03563417|Procedure|Percuteneous Coronary Intervention|PCI of Chronic Total Occlusions
16409462|NCT03563417|Other|Optimal Medical Therapy|Initiation and titration of optimal medical therapy in the control arm.
16409466|NCT03557619|Drug|Venetoclax|tablet; oral
16409473|NCT03539822|Drug|Cabozantinib|by mouth
16409474|NCT03539822|Drug|Durvalumab|infusion
16409475|NCT03539822|Drug|Tremelimumab|infusion
16409479|NCT03539536|Drug|Telisotuzumab vedotin|Intravenous (IV) infusion
16409480|NCT03538899|Drug|AProArt|Participants will undergo infusion with autologous hematopoietic cells transduced with a lentiviral vector, AProArt, which contains the correct form of DCLRE1C complementary deoxyribonucleic acid DNA, after receiving sub-ablative, exposure-targeted busulfan conditioning.
16409481|NCT03538899|Device|CliniMACS® CD34 Reagent System cell sorter device|Processing of hematopoietic progenitor cells to select CD34 cells, using the CliniMACS® CD34 Reagent System, prior to infusion.
16409482|NCT03538899|Drug|Busulfan|Busulfan is a cell cycle non-specific alkylating antineoplastic agent, in the class of alkyl sulfonates. Patients will receive low-dose busulfan conditioning targeted over 2 days to achieve a cumulative area under the curve (AUC) of 20 mg*hr/L.
16409483|NCT03528408|Drug|Nivolumab|Nivolumab 240 mg IV over 30 minutes given Day 1, 15 and 29 of each Cycle
16409484|NCT03528408|Drug|Ipilimumab|Ipilimumab 1 mg/kg IV over 60 minutes given Day 1 of each Cycle
16409485|NCT03523312|Radiation|Hypofractionated ablative IMRT (HFA-IMRT)|total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions
16409486|NCT03523312|Drug|capecitabine|Oral capecitabine at 825 mg/m2 BID on the days of RT. 5 Fluorouracil (5FU) at 250mg/m2/day, 7 days per week by a continuous IV infusion via an outpatient infusion pump) may be used instead at the discretion of the treating physician.
16409487|NCT03521037|Drug|Rucaparib camsylate|In Part I, eligible patients will receive a single oral dose of 600 mg rucaparib followed by intensive plasma PK sampling up to Day 7 (hour 144). In Part II, patients may continue to receive continuous oral rucaparib in 28 day cycles.
16409488|NCT03509571|Other|Ketogenic Diet|Enteral feeding via nasogastric (NG) or nasojejunal (NJ) tubes with ketogenic diet will start within 72 hours of injury and solid feeding will start as soon as the patient is able to swallow. This diet is a high-fat, low-carbohydrate diet (lipid to carbohydrate + protein ratio of 3:1) that will include ≈75% total energy as fat, ≈20% as protein, and ≈5% as carbohydrate and fiber.
16409489|NCT03509571|Other|Standard Diet|Enteral feeding via nasogastric (NG) or nasojejunal (NJ) tubes with SD diet will start within 72 hours of injury and solid feeding will start as soon as the patient is able to swallow. This diet includes ≈35% total energy as fat, ≈27% as protein, and ≈44% as carbohydrate and fiber.
16409490|NCT03509467|Behavioral|Personalized Information|Personalized information about ways that participants can protect themselves and their child from developing melanoma.
16409491|NCT03509467|Behavioral|Standard Information|Standard information about ways that participants can protect themselves and their child from developing melanoma.
16409492|NCT03509467|Other|DNA Extraction Determination of MC1R Genotypes|After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
16409493|NCT03504917|Drug|Balovaptan|Participants will receive 10 mg of oral administration balovaptan once a day (QD).
16409494|NCT03504917|Drug|Placebo|Participants will receive matching placebo.
16409495|NCT03502707|Biological|Placebo|Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
16409496|NCT03502707|Biological|RSV preF Protein 50 mcg|RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
16409497|NCT03502707|Biological|RSV preF Protein 150 mcg|RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
16409498|NCT03502707|Biological|Ad26.RSV.preF 1*10^11 vp|Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
16409499|NCT03502707|Biological|Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg|Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
16409500|NCT03502707|Biological|Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg|Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
16409501|NCT03502707|Biological|Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg|Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
16409502|NCT03502707|Biological|Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg|Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
16409503|NCT03502707|Biological|Selected Regimen|A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
16409504|NCT03502265|Other|Otteroo|Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
16409505|NCT03492177|Drug|selexipag (Uptravi)|Film-coated tablets for oral administration
16409506|NCT03490838|Drug|177Lu-PSMA-R2|radio-ligand therapy
16409507|NCT03482557|Device|CESM|Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone
16409508|NCT03482557|Device|MRI|MRI uses magnets to create a detailed image of the tissues and bones inside of the body
16409510|NCT03444701|Drug|E7130|Starting dose is lower than one at which the first DLT was observed in the 2-week regimen administered on Day 1 of Cycle 1.
16409511|NCT03436485|Drug|ODM-208|co-administered with glucocorticoid and fludrocortisone, orally daily
16409512|NCT03423160|Other|None--observational|Observational study of behavior and electrical brain activity
16409513|NCT03422328|Drug|macitentan|macitentan 10 mg, film-coated tablet, oral use
16409514|NCT03422094|Biological|NeoVax|At each vaccination time point, patients will receive up to 20 synthetic long peptides co-administered with 1.5 mg of poly-ICLC divided into a maximum of four injections (pools). Each pool (of vaccine + poly IC:LC) will be administered to one of the four limbs (right axilla, left axilla, right inguina, left inguina) by subcutaneous injection.
16409515|NCT03422094|Biological|Nivolumab|Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
16409516|NCT03422094|Biological|Ipilimumab|Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)
16409517|NCT03422094|Procedure|Research blood draw|-Baseline, cycle 2 day 1, cycle 4 day 1, and time of progression or discontinuation of treatment
16409518|NCT03422094|Procedure|Leukapheresis for research|-Baseline, cycle 4 day 1, and time of progression or discontinuation of treatment
16409519|NCT03402659|Drug|neflamapimod|40 mg neflamapimod capsule
16409520|NCT03402659|Other|placebo|matching placebo capsule
16409521|NCT03398148|Drug|risankizumab IV|risankizumab intravenous (IV) infusion
16409522|NCT03398148|Drug|placebo for risankizumab|placebo for risankizumab
16409523|NCT03398148|Drug|risankizumab SC|risankizumab subcutaneous (SC) injection
16409524|NCT03396575|Biological|TTRNA-DC vaccines with GM-CSF|After chemoradiation subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. Monthly DC vaccines will be given during TMZ Cycles 2-5 for Groups A and B and 48-96 hours after completion of TMZ Cycle 6 Day 21 for Group A and 12-36 hours after HSCs for Group B. All subjects will receive an additional two bi-weekly vaccines during Cycle 6 for a total of 10 DC vaccines. All DC vaccines will be embedded with GM-CSF (150 µg per injection) and given intradermal.
16409525|NCT03396575|Biological|TTRNA-xALT|During TMZ Cycle 4 and with DC vaccine #6, an infusion of T-cells will be administered to all subjects.
16409526|NCT03396575|Drug|Cyclophosphamide + Fludarabine Lymphodepletive Conditioning|Subjects in Group B, however, will receive lymphodepletion with cyclophosphamide + fludarabine after DC vaccination and prior to the intravenous infusion of ex vivo expanded tumor-reactive lymphocytes.
16409527|NCT03396575|Drug|Dose-Intensified TMZ|After chemoradiation, subjects in Group A will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. All subjects will have an additional five cycles of dose-intensified TMZ (for a total of 6 Cycles) with concurrent monthly DC vaccinations.
16409528|NCT03396575|Drug|Td vaccine|A full Td booster vaccine will be administered IM at Vaccine #1 to all subjects, and vaccine site pretreatment will be administered to all subjects prior to Vaccine#3, #6, and #8.
16409529|NCT03396575|Biological|Autologous Hematopoietic Stem Cells (HSC)|During Cycle 4, all patients will receive HSCs prior to xALT infusion and DC vaccine #6.
16409530|NCT03395197|Drug|Talazoparib with enzalutamide|Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
16409531|NCT03395197|Drug|Placebo with enzalutamide|Placebo plus enzalutamide 160 mg/day
16409532|NCT03393845|Drug|Pembrolizumab|Pembrolizumab 200mg IV, 21 day cycles
16409533|NCT03393845|Drug|Fulvestrant|Fulvestrant, 500mg IM, 28 day cycles.
16409534|NCT03391869|Biological|Ipilimumab|Given IV
16409535|NCT03391869|Procedure|Local Consolidation Therapy|Undergo radiation and/or surgery
16409536|NCT03391869|Biological|Nivolumab|Given IV
16409537|NCT03391869|Other|Quality-of-Life Assessment|Ancillary studies
16409538|NCT03391869|Radiation|Radiation Therapy|Undergo radiation
16409539|NCT03391869|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16409543|NCT03387462|Drug|Emtricitabine / Tenofovir Disoproxil Oral Tablet|Open label daily emtricitabine/tenofovir disoproxil oral tablet
16409544|NCT03387462|Other|DOT Diary mobile app|DOT Diary mobile application for tracking medication adherence and sexual activities.
16409545|NCT03385005|Device|Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.|The study involves the administration of various electrical pulses being delivered to muscles of the forearm from a neuromuscular stimulator in order to evoke different hand and finger movements. The grip strength and evoked forces at the fingertips will also be measured using sensors.
16409546|NCT03384836|Other|Laboratory Biomarker Analysis|Correlative studies
16409547|NCT03384836|Biological|Pembrolizumab|Given IV
16409548|NCT03384836|Drug|Propranolol Hydrochloride|Given PO
16409553|NCT03363919|Device|NeuroStar TMS Therapy® System|The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with MDD who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.
16409554|NCT03363919|Device|NeuroStar XPLOR®|NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.
16409555|NCT03311555|Drug|Apalutamide|240mg tablet daily for 36 weeks
16409556|NCT03311555|Drug|Androgen deprivation|ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
16409557|NCT03311555|Radiation|Salvage radiation therapy|On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
16409558|NCT03311555|Drug|Docetaxel|About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
16409559|NCT03307915|Biological|Ad26.Mos4.HIV|Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
16409560|NCT03307915|Biological|MVA-Mosaic|Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.
16409561|NCT03307915|Biological|Clade C gp140 + Mosaic gp140|Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
16409562|NCT03307915|Drug|Placebo|Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
16409565|NCT03295721|Drug|HTX-011|HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
16409566|NCT03295721|Drug|Saline Placebo|Saline placebo by instillation
16409567|NCT03295721|Drug|Bupivacaine HCl|Bupivacaine HCl without epinephrine, 50 mg by injection
16409568|NCT03295721|Device|Luer-lock applicator|Applicator for instillation
16409569|NCT03295721|Device|Vial access device|Device for withdrawal of drug product
16409570|NCT03287245|Drug|Idasanutlin|All participants will receive 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation or end of study (up to 2 years). Intra-participant dose-escalation to 200 mg daily for 5 days may be permitted after Cycle 3 for those who demonstrate no hematocrit (Hct) control and/or for those with inadequately controlled leukocytosis and/or thrombocytosis in which the investigator judges that better control is important.
16409571|NCT03286088|Diagnostic Test|TransEsophageal Echocardiography and TransEsophageal Echocardiography|imaging as standard practice
16409572|NCT03286088|Diagnostic Test|Cardiac Magnetics Resonance|imaging as standard practice
16409573|NCT03286088|Diagnostic Test|MitraClip|imaging as standard practice
16409574|NCT03285412|Drug|Ribociclib|Ribociclib is a drug designed to block certain proteins called cyclin-dependent protein kinases 4 and 6 (CDK4/6). These proteins are needed for cells to divide and may also control the ability of certain cancers to grow.
16409575|NCT03285412|Other|Endocrine therapy|Hormone therapy
16409576|NCT03279718|Procedure|Periodontal Treatment|Scaling and root planing
16409577|NCT03278821|Behavioral|Self Match|Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
16409578|NCT03278821|Behavioral|Expert Match|Referral as usual to one of five possible treatment options. The referral is based on baseline data from the patient and by the means of an algorithm, used in daily clinical praxis.
16409579|NCT03272373|Device|NexGen TM Monoblock Tibia|Primary cementless tibia total knee arthroplasty
16409580|NCT03272373|Device|NexGen TM Modular Tibia|Primary cementless tibia total knee arthroplasty
16409581|NCT03264664|Drug|E7386|Oral immediate release tablets.
16409582|NCT03264404|Drug|Pembrolizumab|Pembrolizumab 200 mg IV every 3 weeks until progression
16409583|NCT03264404|Drug|Azacitidine|50 mg/m2 subcutaneous daily for 5 days every 28 days
16409584|NCT03246074|Drug|Fostamatinib and Paclitaxel|"Drug: Fostamatinib (oral; 100 mg, 150 mg, or 200 mg)
~Drug: Paclitaxel (60-80 mg/m2)"
16409585|NCT03238326|Drug|Brexpiprazole|Once daily, oral tablets
16409586|NCT03237780|Drug|Atezolizumab|Given IV
16409587|NCT03237780|Drug|Eribulin Mesylate|Given IV
16409588|NCT03237780|Other|Laboratory Biomarker Analysis|Correlative studies
16409589|NCT03237481|Drug|HTX-011|HTX 011 (bupivacaine/meloxicam), 300 mg/9 mg by instillation
16409590|NCT03237481|Drug|Bupivacaine HCl|Bupivacaine HCl without epinephrine, 75 mg by injection
16409591|NCT03237481|Drug|Saline placebo|Saline placebo by instillation
16409592|NCT03237481|Device|Luer-lock applicator|Applicator for instillation
16409593|NCT03237481|Device|Vial access device|Device for withdrawal of drug product
16409594|NCT03225378|Other|Fluid loading of 500 mL of crystalloid solution|Infusion of 500 mL of crystalloid solution in less than 15 minutes
16409595|NCT03225378|Other|Passive Leg Raising test|This intervention is done before the fluid loading in order to predict fluid responsiveness.
16409596|NCT03223298|Drug|Botulinum toxin type A|37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
16409597|NCT03223298|Drug|0.9% Sodium Chloride Injection|1cc syringe
16409598|NCT03216187|Drug|Pregabalin|pregabalin 150 mg capsules
16409599|NCT03216187|Drug|Placebos|capsules identical to pregabalin but without active drug
16409600|NCT03208907|Drug|CQ coadministered with PQ|115 subjects will be given 3-day regimen treatment with the schizonticidal drug Chloroquine concomitantly to 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day.
16409601|NCT03208907|Drug|DHA-PQP coadministered with PQ|In this treatment group, others 115 subjects will take DHA-PQP for three days and Primaquine for 14 days in the following dose: 0.50 mg/kg/day.
16409602|NCT03208907|Drug|CQ and PQ starting on Day 42|115 subjects will be given 3-day regimen treatment with Chloroquine with a 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day starting on Day 42 after first dose of the schizonticidal drug.
16409603|NCT03208907|Drug|DHA-PQP and PQ starting on Day 42|115 subjects will be given 3-day regimen treatment with DHA-PQP with a 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day starting on Day 42 after first dose of the schizonticidal drug.
16409604|NCT03207672|Drug|E7389-LF|intravenous infusion
16409612|NCT03198078|Drug|Brexpiprazole (OPC-34712)|Once-daily, tablets
16409613|NCT03198078|Drug|Aripiprazole|Once-daily, tablets
16409614|NCT03198078|Drug|Placebo|Once-daily, tablets
16409615|NCT03170882|Drug|Ixazomib|Ixazomib capsules
16409616|NCT03170882|Drug|Pomalidomide|Pomalidomide capsules
16409617|NCT03170882|Drug|Dexamethasone|Dexamethasone tablets
16409618|NCT03148327|Drug|Durvalumab (MEDI 4736)|Early studies has shown to possibly reduce the growth of certain types of lung cancer
16409619|NCT03148327|Radiation|Radiotherapy|Stereotactic Body Radiation Therapy (SABR)
16409629|NCT03133676|Drug|KA34|50 µg - 400 µg intra-articular injection (single or multiple doses)
16409630|NCT03133676|Drug|Placebo|50 µg - 400 µg intra-articular injection (single or multiple doses)
16409631|NCT03126851|Other|Label|Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
16409632|NCT03124875|Device|LimFlow Stent Graft System|Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
16409633|NCT03107897|Other|Pre-habilitation|Eight - Twelve visits to physical therapy prior to their TAVR procedure.
16409634|NCT03106779|Drug|ABL001|40 mg tablets will be taken orally twice a day (BID)
16409635|NCT03106779|Drug|Bosutinib|500 mg tablets will be taken orally once daily (QD)
16409636|NCT03099174|Drug|Xentuzumab|Once weekly administrated through one hour intravenous infusion
16409637|NCT03099174|Drug|Abemaciclib|Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort A) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours
16409638|NCT03099174|Drug|Letrozole|Once a day
16409639|NCT03099174|Drug|Anastrozole|Once a day
16409640|NCT03099174|Drug|Fulvestrant|Once a month, with an additional dose given two weeks after the first dose. Each dose is given as two slow injections lasting one to two minutes, with one injection being given into the muscle of each buttock
16409641|NCT03099174|Drug|Abemaciclib|Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort D) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours
16409642|NCT03083132|Drug|modafinil 50mg|1 capsule oral daily
16409643|NCT03083132|Drug|Placebo oral capsule|1 capsule oral daily
16409644|NCT03064126|Device|RANGER™ Paclitaxel Coated Balloon|"A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries."
16409645|NCT03064126|Drug|Paclitaxel|The RANGER™ Balloon is coated with the drug Paclitaxel.
16409646|NCT03064126|Procedure|Standard Balloon Angioplasty|"A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries."
16409647|NCT03060629|Biological|Ad26.Mos4.HIV|Participants will receive Ad26.Mos4.HIV 5x10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
16409648|NCT03060629|Biological|Clade C gp140|Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
16409649|NCT03060629|Biological|Placebo|Participants will receive matching placebo.
16409650|NCT03059173|Dietary Supplement|Myo-Inositol + Levomefolic acid|Dietary supplement Inofolic containing myo-inositol (4 g) and Levomefolic acid(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle.
16409651|NCT03059173|Drug|Clomiphene Citrate|Clomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary.
16409652|NCT03059173|Dietary Supplement|placebo|a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
16409653|NCT03051971|Device|Vibrating Mesh Nebulizer|short-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
16409654|NCT03051971|Device|Jet Nebulizer|short-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
16409655|NCT03046862|Drug|Durvalumab|Durvalumab 1.12 g iv on D1 every 3 weeks
16409656|NCT03046862|Drug|Tremelimumab|Tremelimumab 75mg iv on D1 every 3 weeks
16409657|NCT03046862|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 iv on D1& D8 every 3 weeks
16409658|NCT03046862|Drug|Cisplatin|Cisplatin 25 mg/m2 iv on D1& D8 every 3 weeks
16409659|NCT03025308|Drug|Filgotinib|Tablet(s) administered orally once daily
16409660|NCT03025308|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
16409661|NCT03015532|Drug|HTX-011|HTX-011 (bupivacaine/meloxicam), via instillation
16409662|NCT03015532|Drug|Saline Placebo|Saline placebo via injection
16409663|NCT03015532|Drug|Bupivicaine HCl|Bupivacaine HCl without epinephrine
16409664|NCT03015532|Drug|Ropivacaine|Ropivacaine, via injection
16409672|NCT02944136|Behavioral|enhanced usual care|usual care from health providers
16409673|NCT02944136|Behavioral|stepped collaborative care|Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
16409674|NCT02936596|Drug|Ursodeoxycholic acid combination of immunosuppressive agents|Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
16409675|NCT02936596|Drug|Ursodeoxycholic Acid|Ursodeoxycholic Acid
16409676|NCT02935686|Biological|Ad26.Mos4.HIV|Ad26.Mos4.HIV at a dose of 5*10^10 viral particles (vp), administered intramuscularly.
16409677|NCT02935686|Biological|Clade C gp140 plus adjuvant|Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection administered intramuscularly.
16409678|NCT02935686|Biological|Clade C gp140/Mosaic gp140 plus adjuvant|Clade C gp140 and Mosaic gp140 (each 125 mcg of total protein) mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection, administered intramuscularly.
16409679|NCT02935686|Other|Placebo|Placebo Containing 0.9 percent normal saline, administered intramuscularly.
16409680|NCT02935686|Biological|gp140 HIV Bivalent Vaccine|gp140 HIV Bivalent Vaccine is adjuvanted protein co-formulation with a dosage strength of 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant).
16409681|NCT02932410|Drug|Macitentan|Dispersible tablet; Oral use
16409682|NCT02932410|Other|Standard-of-care|Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and i.v./s.c. prostanoids.
16409683|NCT02930122|Drug|anakinra (150mg)|intraarticular administration
16409684|NCT02930122|Other|Saline intraarticularly|intraarticular administration
16409685|NCT02925234|Drug|Panitumumab|Panitumumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of panitumumab might be expected based on their molecular tumor profile.
16409686|NCT02925234|Drug|Olaparib|Olaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of olaparib might be expected based on their molecular tumor profile.
16409687|NCT02925234|Drug|Dabrafenib|Dabrafenib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dabrafenib might be expected based on their molecular tumor profile.
16409688|NCT02925234|Drug|Nilotinib|Nilotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nilotinib might be expected based on their molecular tumor profile.
16409689|NCT02925234|Drug|Trametinib|Trametinib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trametinib might be expected based on their molecular tumor profile.
16409690|NCT02925234|Drug|Erlotinib|Erlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erlotinib might be expected based on their molecular tumor profile.
16409691|NCT02925234|Drug|Trastuzumab and Pertuzumab (combination treatment)|Trastuzumab and Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trastuzumab + pertuzumab might be expected based on their molecular tumor profile.
16409692|NCT02925234|Drug|Vemurafenib and Cobimetinib (combination treatment)|Vemurafenib + Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib + Cobimetinib might be expected based on their molecular tumor profile.
16409693|NCT02925234|Drug|Vismodegib|Vismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.
16409694|NCT02925234|Drug|Regorafenib|Regorafenib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.
16409695|NCT02925234|Drug|Nivolumab|Nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nivolumab might be expected based on their molecular tumor profile.
16409696|NCT02925234|Drug|Afatinib|Afatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Afatinib might be expected based on their molecular tumor profile.
16409697|NCT02925234|Drug|Dabrafenib and trametinib|Dabrafenib + trametinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Dabrafenib + Trametinib might be expected based on their molecular tumor profile.
16409698|NCT02925234|Drug|Ribociclib|Ribociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Ribociclib might be expected based on their molecular tumor profile.
16409699|NCT02925234|Drug|Lenvatinib|Lenvatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Lenvatinib might be expected based on their molecular tumor profile.
16409700|NCT02925234|Drug|Pembrolizumab|Pembrolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Pembrolizumab might be expected based on their molecular tumor profile.
16409701|NCT02925234|Drug|Durvalumab|Durvalumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Durvalumab might be expected based on their molecular tumor profile.
16409702|NCT02925234|Drug|Rucaparib|Rucaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Rucaparib might be expected based on their molecular tumor profile.
16409703|NCT02925234|Drug|Axitinib|Axitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.
16409704|NCT02925234|Drug|Palbociclib|Palbociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Palbociclib might be expected based on their molecular tumor profile.
16409705|NCT02925234|Drug|Crizotinib|Crizotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Crizotinib might be expected based on their molecular tumor profile.
16409706|NCT02925234|Drug|Sunitinib|Sunitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Sunitinib might be expected based on their molecular tumor profile.
16409707|NCT02925234|Drug|Cabozantinib|Cabozantinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Cabozantinib might be expected based on their molecular tumor profile.
16409708|NCT02925234|Drug|Abemaciclib|Abemaciclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Abemaciclib might be expected based on their molecular tumor profile.
16409709|NCT02925234|Drug|Alectinib|Alectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.
16409710|NCT02925234|Drug|Atezolizumab and Bevacizumab|Atezolizumab + Bevacizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab + Bevacizumab might be expected based on their molecular tumor profile.
16409711|NCT02925234|Drug|Ipilimumab and nivolumab|Ipilimumab+nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of ipilimimab + nivolumab might be expected based on their molecular tumor profile.
16409712|NCT02925234|Drug|Entrectinib|Entrectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of entrectinib might be expected based on their molecular tumor profile.
16409713|NCT02925234|Drug|Talazoparib|Talazoparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of talazoparib might be expected based on their molecular tumor profile.
16409714|NCT02925234|Drug|Dacomitinib|Dacomitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dacomitinib might be expected based on their molecular tumor profile.
16409715|NCT02925234|Drug|Lorlatinib|Lorlatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of lorlatinib might be expected based on their molecular tumor profile.
16409716|NCT02925234|Drug|Erdafitinib|Erdafitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erdafitinib might be expected based on their molecular tumor profile.
16409887|NCT01668719|Drug|Dexamethasone|Given PO or IV
16409717|NCT02925234|Drug|Alpelisib|Alpelisib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of alpelisib might be expected based on their molecular tumor profile.
16409718|NCT02912559|Drug|Atezolizumab|Given IV
16409719|NCT02912559|Drug|Fluorouracil|Given IV
16409720|NCT02912559|Other|Laboratory Biomarker Analysis|Correlative studies
16409721|NCT02912559|Drug|Leucovorin Calcium|Given IV
16409722|NCT02912559|Drug|Oxaliplatin|Given IV
16409723|NCT02912559|Other|Quality-of-Life Assessment|Ancillary studies
16409724|NCT02893865|Device|Continuous positive airway pressure|Continuous positive airway pressure treatment during three months with adherence recording
16409725|NCT02893865|Device|Sham-continuous positive airway pressure|Sham-continuous positive airway pressure during three months with adherence recording
16409728|NCT02788045|Biological|Ad26.Mos.HIV|Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
16409729|NCT02788045|Biological|Ad26.Mos4.HIV|Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5mL injection administered intramuscularly.
16409730|NCT02788045|Biological|Clade C gp140|Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
16409731|NCT02788045|Drug|Placebo|Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
16409732|NCT02784288|Procedure|Neck Dissection|All patients will undergo neck dissection of the cervical lymph nodes
16409733|NCT02784288|Procedure|Standard-of-Care (SOC) Transoral Surgery of Primary Site|Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site.
16409734|NCT02784288|Radiation|SOC Radiation|Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.
16409735|NCT02784288|Drug|SOC Carboplatin|Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).
16409736|NCT02784288|Drug|SOC Paclitaxel|Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).
16409737|NCT02784288|Procedure|Videofluoroscopy|All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
16409738|NCT02779478|Procedure|Bronchoscopy|
16409739|NCT02763566|Drug|Abemaciclib|Administered orally
16409740|NCT02763566|Drug|Anastrozole|Administered orally
16409741|NCT02763566|Drug|Letrozole|Administered orally
16409742|NCT02763566|Drug|Placebo|Administered orally
16409743|NCT02763566|Drug|Fulvestrant|Administered intramuscularly
16409744|NCT02758431|Drug|Acyline|Acyline 300ug/kg injection will be administered on Day 0 and on day 14
16409745|NCT02758431|Drug|Placebo Gel|Placebo gel packet applied daily for 28 days.
16409746|NCT02758431|Drug|Placebo Tablet|Placebo oral tablet taken daily for 28 days.
16409747|NCT02758431|Drug|Testosterone Gel|Testosterone Gel applied daily for 28 days
16409748|NCT02758431|Drug|Arimidex|Arimidex Oral Tablet 1mg taken orally daily for 28 days
16409749|NCT02718131|Device|INFUSE Bone Graft (BMP-2)|The INFUSE bone graft, containing BMP-2 on a collagen sponge, will be wrapped around the tibia during the surgical process.
16409750|NCT02718131|Procedure|Control Group|The control group will receive the standard surgical protocol, without addition of the INFUSE device.
16409751|NCT02713386|Drug|Carboplatin|Given IV
16409752|NCT02713386|Drug|Paclitaxel|Given IV
16409753|NCT02713386|Drug|Ruxolitinib Phosphate|Given PO
16409754|NCT02713386|Procedure|Therapeutic Conventional Surgery|Undergo TRS
16409755|NCT02710240|Drug|Indocyanine Green (ICG)|
16409756|NCT02710240|Radiation|Intraoperative near-infrared (NIR)|
16409757|NCT02698293|Drug|Gliolan|orally, 40 mg/kg 4-6 hours prior to light application
16409758|NCT02698293|Drug|Vitamin D3 cholecalciferol)|Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.
16409759|NCT02698293|Other|Photodynamic Therpay|"Approximately 4-6 hours after photosensitizer administration, activating light will be applied.
~The target mucosal lesion will be identified based on the initial clinical evaluation. Treatment light will be generated using a Modulight ML7710-630-6K diode laser, This laser produces up to 6W total power, with a peak wavelength of 630nm and 90% of laser power within 630-633 nm.
~The light fluence (doses) will be 50 and 100 Joules per square centimeter."
16409760|NCT02690558|Drug|pembrolizumab, gemcitabine and cisplatin|neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
16409761|NCT02687464|Other|Non-operative treatment|"will receive a minimum of 12 hours intravenous antibiotics and then receive oral antibiotics once they have shown clinical improvement (a total course of 10 days of antibiotics (intravenous and oral). They will be discharged home once they meet a standardized set of criteria to be used in all centers.
~The choice of antibiotics will vary between centers and will be the antibiotic regimen that is current standard of care in that center allowing each center to maintain current protocols will improve study feasibility and increase generalization of the results."
16409762|NCT02687464|Procedure|Appendectomy|"will undergo laparoscopic appendectomy within 18 hours of randomization and will receive intravenous antibiotics per each site's standard care, from the time of randomization and post-operatively according to a defined and standardized treatment regimen based on consensus for this trial.
~Children with a visibly normal appendix or non-perforated acute appendicitis will receive no further antibiotics; children with perforated appendicitis will continue to receive intravenous antibiotics for a minimum of 3 days, and then per local practice. The type of antibiotics used in each center will be identical to those used in the non-operative treatment group and are not specified by the study."
16409763|NCT02686814|Device|17mm MDT-2215 aortic valve bioprosthesis|
16409764|NCT02661464|Biological|Ad26.ZEBOV|No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to Ad26.ZEBOV vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.
16409765|NCT02661464|Biological|MVA-BN-Filo|No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to MVA-BN-Filo vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.
16409766|NCT02659020|Drug|Olaratumab|Administered IV
16409767|NCT02659020|Drug|Gemcitabine|Administered IV
16409768|NCT02659020|Drug|Docetaxel|Administered IV
16409769|NCT02659020|Drug|Placebo|Administered IV
16409770|NCT02657889|Drug|niraparib|
16409771|NCT02657889|Biological|pembrolizumab|
16409772|NCT02654860|Drug|Paracetamol 3%|Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery
16409773|NCT02654860|Drug|Placebo injection containing Saline solution 0.9%|Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.
16409774|NCT02654860|Drug|Hyperbaric Bupivacaine HCl 0.5%|NIMP, spinal anaesthetic before the surgical procedure
16409775|NCT02653092|Drug|Insulin|
16409776|NCT02653092|Drug|Intralipid|
16409777|NCT02653092|Drug|Dextrose|
16409778|NCT02653092|Drug|Heparin|
16409779|NCT02653092|Drug|GnRH|
16409780|NCT02653092|Procedure|Hyperinsulinemic Euglycemic Clamp|
16409781|NCT02643056|Drug|Panitumumab|IV administration every 2 weeks
16409782|NCT02635672|Drug|VIP152 (BAY 1251152)|The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.
16409783|NCT02635672|Drug|VIP152 (BAY 1251152) 30 mg|30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
16409784|NCT02634307|Drug|ALKS 8700|Administered as specified in the treatment arm.
16409785|NCT02633527|Drug|Placebo|Placebo was administered once daily
16409786|NCT02633527|Drug|100mg SPN-812|100mg SPN-812 was administered once daily and compared to placebo
16409787|NCT02633527|Drug|200mg SPN-812|200mg SPN-812 was administered once daily and compared to placebo
16409788|NCT02633527|Drug|300mg SPN-812|300mg SPN-812 was administered once daily and compared to placebo
16409789|NCT02633527|Drug|400mg SPN-812|400mg SPN-812 was administered once daily and compared to placebo
16409790|NCT02631733|Drug|Ferumoxytol|Given IV
16409791|NCT02631733|Drug|Irinotecan Sucrosofate|Given IV
16409792|NCT02631733|Other|Laboratory Biomarker Analysis|Correlative studies
16409793|NCT02631733|Procedure|Magnetic Resonance Imaging|Undergo MRI
16409794|NCT02631733|Drug|Veliparib|Given PO
16409795|NCT02630316|Drug|Inhaled Treprostinil|Inhaled treprostinil (6 mcg/breath) administered four times daily
16409796|NCT02630316|Drug|Placebo|Placebo administered four times daily
16409797|NCT02611063|Drug|fostamatinib|100mg qd, 150mg qd, or 100mg bid
16409798|NCT02596412|Other|use the module with augmented reality (Mini-Docs) on tablet during TB injection|Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology
16409799|NCT02574481|Device|ELUVIA (Stent Implantation)|Drug-eluting self-expanding stent implantation during the index procedure.
16409800|NCT02574481|Device|Zilver PTX (Stent Implantation)|Drug-eluting self-expanding stent implantation during the index procedure.
16409801|NCT02563561|Drug|Apaziquone|One dose of apaziquone administered by intravesical administration
16409802|NCT02563561|Other|Placebo|Matching placebo (containing 12 mg FD&C red #40, 15 mg sodium chloride, and 10 mg mannitol was supplied in identical appearing vials) by intravesical administration.
16409803|NCT02513186|Drug|lenalidomide|Pharmaceutical form: tablet Route of administration: oral
16409804|NCT02513186|Drug|bortezomib|Pharmaceutical form: lyophilized powder for subcutaneous injection Route of administration: subcutaneous
16409805|NCT02513186|Drug|cyclophosphamide|Pharmaceutical form: tablet Route of administration: oral
16409806|NCT02513186|Drug|dexamethasone|Pharmaceutical form: tablet or solution for infusion Route of administration: oral or intravenous
16409807|NCT02513186|Drug|isatuximab SAR650984|Pharmaceutical form: solution for infusion Route of administration: intravenous
16409808|NCT02508493|Other|THINC-it Tool|"Digitalized cognitive test application administering the following cognitive test components:
~Digit Symbol Substitution Test (DSST)
~Choice Reaction Time (CRT)
~One-back working memory tool
~Trail Making Test B (TMT-B)
~Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
16409809|NCT02508493|Other|Pencil-and-paper Cognitive Tests|"Pencil-and-paper versions of the following cognitive tests:
~Digit Symbol Substitution Test (DSST)
~Trail Making Test B (TMT-B)
~Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)
~Variant of Choice Reaction Time (CRT)
~Variant of the One-back working memory tool"
16409810|NCT02501642|Behavioral|Concussion Coach|smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies
16409811|NCT02501642|Other|Treatment as usual|Treatment as usual
16409812|NCT02494986|Drug|Rilpivirine|Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected background regimen consisting of other ARVs.
16409813|NCT02492009|Behavioral|Standard Resource Sheet|Women allocated to the control intervention will login to the study website and receive a printable PDF containing references to standard published information on antidepressant use in pregnancy. This ensures women have access to accurate information on the benefits and risks of antidepressant medication in pregnancy (even though they will not receive the PDA).
16409814|NCT02492009|Behavioral|Patient Decision Aid|"The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:
~Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure;
~(a) Evidence-based information on the risks and benefits of both untreated depression and antidepressant treatment, (b) exercises to help women determine which risks and benefits are most important to them; and
~A summary section that outlines the information reviewed and which benefits and risks they deemed most important.
~At the end of the PDA, women allocated to this intervention will ALSO receive the standard resource sheet which is being used as the placebo comparator."
16409815|NCT02471118|Drug|Adalimumab 40 mg|Adalimumab will be self-administered via subcutaneous (SC) injection
16409816|NCT02471118|Drug|Placebo|Placebo will be self-administered via subcutaneous (SC) injection
16409824|NCT02453282|Biological|MEDI4736 (Durvalumab)|
16409825|NCT02453282|Biological|MEDI4736 (Durvalumab)+Tremelimumab|
16409826|NCT02453282|Drug|Paclitaxel + Carboplatin|Chemotherapy Agents
16409827|NCT02453282|Drug|Gemcitabine + Cisplatin|Chemotherapy Agents
16409828|NCT02453282|Drug|Gemcitabine + Carboplatin|Chemotherapy Agents
16409829|NCT02453282|Drug|Pemetrexed + Cisplatin|Chemotherapy Agents
16409830|NCT02453282|Drug|Pemetrexed + Carboplatin|Chemotherapy Agents
16409831|NCT02453282|Biological|Tremelimumab|
16409832|NCT02429791|Drug|DTG 50 mg|Participants will take one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet will contain 52.62 mg dolutegravir sodium salt, which is equivalent to 50 mg dolutegravir free acid.
16409833|NCT02429791|Drug|RPV 25 mg|Participants will take one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet will contain 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of RPV.
16409834|NCT02429791|Drug|CAR|CAR will include following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI
16409835|NCT02422797|Drug|DTG 50 mg|Participants will take one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet will contain 52.62 mg dolutegravir sodium salt, which is equivalent to 50 mg dolutegravir free acid.
16409836|NCT02422797|Drug|RPV 25 mg|Participants will take one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet will contain 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of RPV.
16409837|NCT02422797|Drug|CAR|CAR will include following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI.
16409838|NCT02417285|Drug|Obinutuzumab|1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8.
16409839|NCT02417285|Drug|CC-122|CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab).
16409840|NCT02408887|Procedure|Total Thyroidectomy (TT)|Total removal of thyroid
16409841|NCT02408887|Procedure|Prophylactic central neck lymph nodedissection (pCND)|Lymph node dissection
16409842|NCT02398773|Procedure|Computed Tomography|Undergo PET/CT
16409843|NCT02398773|Drug|F-18 16 Alpha-Fluoroestradiol|Given IV
16409844|NCT02398773|Other|Laboratory Biomarker Analysis|Correlative studies
16409845|NCT02398773|Procedure|Positron Emission Tomography|Undergo PET/CT
16409846|NCT02398396|Biological|4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics|4CMenB vaccine (Bexsero - Novartis Vaccines and Diagnostics) 0.5ml intra-muscularly; two doses, administered 2 months apart. Each dose of vaccine contains recombinant Neisseria meningitidis group B NHBA fusion protein (50 micrograms); recombinant Neisseria meningitidis group B NadA protein (50 micrograms); recombinant Neisseria meningitidis group B FHbp fusion protein (50 micrograms) and Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 (25 micrograms measured as amount of total protein containing the PorA P1.4)
16409847|NCT02390518|Radiation|Stereotactic Radiosurgery|"Patients with 1 to 5 brain metastases will be treated. Patients will be assigned to one of four cohorts based on the size of their brain lesions. For each patient, a single lesion will be treated at experimental dose level, other metastases (if present) will receive standard SRS doses.
~Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Cohort 1a and 1a Expansion (starting at Dose Level 3) Diameter: ≤ 10 mm Volume: ≤ 0.5236 cm3 26 Gy 28 Gy 30 Gy n/a Cohort 1b Diameter: 11-20 mm Volume: 0.5237-4.1888 cm3 26 Gy 28 Gy 30 Gy n/a Cohort 2 Diameter: 21-30 mm Volume: 4.1889-14.1372 cm3 20 Gy 22 Gy 24 Gy n/a Cohort 3 Diameter: 31-40 mm Volume: 14.1373-33.5103 cm3 17 Gy 19 Gy 21 Gy 23 Gy
~Dose Escalation A non-standard 5+4 design will be used for the dose escalation. For each cohort, an initial group of 5 patients will be accrued at dose level 1 and receive experimental treatment to one of their lesions."
16409848|NCT02359968|Drug|FOLFOX|radiochemotherapy before surgery
16409849|NCT02359968|Drug|CarboP-pacliT|radiochemotherapy before surgery
16409888|NCT01668719|Biological|Elotuzumab|Given IV
16409889|NCT01668719|Other|Laboratory Biomarker Analysis|Correlative studies
16409890|NCT01668719|Drug|Lenalidomide|Given PO
16409891|NCT01515748|Drug|Docetaxel (XRP6976)|Pharmaceutical form:solution for infusion Route of administration: intravenous
16409892|NCT01515748|Drug|Oxaliplatin (SR96669)|Pharmaceutical form:solution for infusion Route of administration: intravenous
16409943|NCT00000648|Drug|Penicillin G potassium|
16409944|NCT00000648|Drug|Ceftriaxone sodium|
16409945|NCT00000647|Drug|CD4-IgG|
16409850|NCT02354014|Drug|Bedaquiline (TMC207)|MC207 oral tablet adult formulation (containing 100 mg TMC207 per tablet) administered as 400 milligram (mg), once daily, for the first 2 weeks, followed by bedaquiline (TMC207) 200 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 1. Cohort 2, 3 and 4 will receive an age appropriate oral tablet formulation containing 20mg TMC207. Bedaquiline (TMC207) tablet administered orally as 200 mg, once daily, for the first 2 weeks, followed by bedaquiline (TMC207) 100 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 2. In Cohort 3, dose of TMC207 8 mg/kg qd for the first 2 weeks, followed by TMC207 4 mg/kg tiw with intakes at least 2 days (48 hours) apart for 22 weeks will be administered. In cohort 4, TMC207 dose will be selected based on the results from the previous cohorts 1, 2 and 3.
16409851|NCT02354014|Drug|Background Regimen (BR)|Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) medications will be dosed according to World Health Organization (WHO) guidelines, National Tuberculosis Program (NTP) guidelines and current standard of care at the site.
16409852|NCT02304289|Drug|Artesunate|Oral Artesunate once-daily for 14 days, dose-escalation
16409853|NCT02298751|Behavioral|Cue Exposure Treatment|
16409854|NCT02282059|Drug|sunitinib|subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice
16409855|NCT02265874|Drug|Habitrol|Patch used daily for 28 weeks
16409856|NCT02265874|Drug|Placebo to Habitrol|
16409857|NCT02172950|Biological|rVIII-SingleChain|Recombinant single-chain coagulation factor VIII
16409858|NCT02159755|Drug|Ibrutinib|Given PO
16409859|NCT02159755|Other|Laboratory Biomarker Analysis|Correlative studies
16409860|NCT02159755|Drug|Palbociclib|Given PO
16409861|NCT02159755|Other|Pharmacological Study|Correlative studies
16409862|NCT02137850|Drug|turoctocog alfa pegol|For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis
16409863|NCT02060721|Drug|Macitentan|Macitentan 10mg, oral tablet, once daily
16409864|NCT02022644|Drug|nanoliposomal irinotecan|The drug named here (nanoliposomal irinotecan) will be used in varying amounts, based on tumor volume.
16409865|NCT02020772|Other|coordinating primary health care|
16409866|NCT02020772|Other|usual primary health care|
16409867|NCT02017444|Drug|AZD4017|
16409868|NCT02017444|Other|Placebo|Matched placebo (matched to AZD4017 arm)
16409869|NCT01980771|Behavioral|BTWB intervention|Men work in groups to complete a intervention that takes approximately two hours to complete.
16409870|NCT01980771|Behavioral|Cancer prevention and screening|Men are provided health education about cancer screening and prevention
16409871|NCT01975090|Device|SENTRY IVC Filter|The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.
16409872|NCT01960023|Drug|Cetuximab|400 mg/m2 IV loading dose followed by weekly cetuximab 250 mg/m2 IV until disease progression
16409873|NCT01960023|Drug|Neratinib|"Phase I portion of the study:
~Dose level 1: 120 mg/day; Dose level 2: 160 mg/day; Dose level 3: 200 mg/day; Dose level 4: 240 mg/day
~Phase II portion of the study: The recommended dose determined in the Phase I portion of the study."
16409874|NCT01885949|Drug|Tivozanib|Oral
16409875|NCT01885949|Drug|Enzalutamide|oral
16409876|NCT01859130|Device|Zimmer Persona Total Knee System|
16409877|NCT01817192|Drug|Adjuvant Chemotherapy|Patients who have undergone complete resection of NSCLC that has been documented histologically to be non-squamous and that is pathological Stage I or IIA, will undergo testing with the 14-Gene Prognostic Assay. Patients determined to be intermediate or high risk and who meet all eligibility criteria will be randomized either to observation or to four cycles of adjuvant therapy with a standard NSCLC platinum-based doublet.
16409878|NCT01817192|Other|Radiographic surveillance|Serial radiographic surveillance is a current standard of care for Stage I or Stage IIA lung cancer. All intermediate or high risk patients randomized to observation or chemotherapy will have routine CT Scans at 6 month intervals until 5 years after enrollment and at yearly intervals thereafter until the end of the study period.
16409879|NCT01817192|Other|14-Gene Prognostic Assay|This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of Stage I or Stage IIA non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as intermediate or high-risk will be randomized to either adjuvant chemotherapy or observation.
16409880|NCT01724606|Radiation|Whole Brain Radiotherapy (WBRT)|WBRT (30 Gy) will be delivered in 10 fractions. Standard opposed lateral fields with multileaf collimation blocking will be used. Treatment will be administered on business days and delivered over an approximate 2 week period. Dexamethasone may be given at the discretion of the treating physician but the dose cannot exceed greater than 16mg daily as it is a strong CYP3A4 inducer. Patients will also receive a proton pump inhibitor with dexamethasone.
16409881|NCT01724606|Drug|Sorafenib|The proposed three dose levels of sorafenib during dose escalation are 200 mg, 400mg, and 600 mg administered daily orally. Patients will be enrolled in cohorts of 3.The first three subjects will take sorafenib 200 mg daily within a few hours after the first RT fraction. Sorafenib will be continued concurrently with WBRT (1 fraction /day x 10 fractions) without breaks and then continued after WBRTfor a total of 21 days. If no dose limiting toxicity (DLT) is observed in a cohort of 3 patients until two weeks after completion of WBRT, the next dose level will be evaluated.
16409882|NCT01675882|Biological|Viaskin Peanut 50 mcg|Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
16409883|NCT01675882|Biological|Viaskin Peanut 100 mcg|Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
16409884|NCT01675882|Biological|Viaskin Peanut 250 mcg|Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
16409885|NCT01675882|Biological|Viaskin Placebo|Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation
16409886|NCT01668719|Drug|Bortezomib|Given SC or IV
16409893|NCT01515748|Drug|S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)|Pharmaceutical form:Tablet Route of administration: Oral
16409894|NCT01492582|Biological|quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)|Given IM
16409895|NCT01492582|Other|laboratory biomarker analysis|Correlative studies
16409896|NCT01492582|Other|survey administration|Ancillary studies
16409897|NCT01492582|Other|medical chart review|Ancillary studies
16409898|NCT01491360|Procedure|LaserACE(R)|Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.
16409899|NCT01476956|Other|Observational study|RA patients on standard DMARD therapy
16409900|NCT01376505|Biological|HER-2 vaccine|Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified with nor-MDP in ISA 720 vehicle. Increasing doses of the combined vaccine preparation emulsified with nor-MDP (0.025) mg and Montanide ISA 720 will be administered in a final volume of 1.0 ml. Starting at dose level 1, 1.0mg of each peptide will be used for vaccination. In increasing dosing cohorts 1.5mg, 2.0mg and 2.5mg will be used. Patients may also receive 6 months booster shots.
16409901|NCT01376505|Biological|Extension HER-2 vaccine trial at OBD|Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified with nor-MDP in ISA 720 vehicle. The dose level has been determined to be cohort 2. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with nor-MDP (0.025) mg and Montanide ISA 720 will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.
16409902|NCT01272050|Radiation|radiation therapy|"RT in the standard arm A will be administered to a total dose of 64 Gy in 32 fractions of 2 Gy over 6.4 weeks. RT in the experimental arm B will be administered to a total dose of 70 Gy in 35 fractions of 2 Gy over 7 weeks.
~Megavoltage equipments with nominal photon energies ≥ 6 MV are required. Rotational techniques such as Tomotherapy®, Rapidarc®, intensity-modulated arc technique (IMAT) and volumetric-modulated arc therapy (VMAT) will also be eligible. The patient will be treated in an isocentric setting and all fields will be applied for 5 days per week for the total RT duration."
16409903|NCT01176916|Drug|Aromasin (exemestane)|the dosage, frequency and duration base on the LPD approved by SFDA.
16409904|NCT00995150|Drug|LNG20|levonorgestrel-releasing intrauterine system for contraception
16409905|NCT00995150|Drug|Mirena|Mirena intrauterine system
16409906|NCT00980538|Drug|Etravirine|Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.
16409907|NCT00855036|Other|Attenuated bedrest|Patients are allowed to ambulate the morning after admission and then can be discharged when eating well and pain is controlled on oral pain medication regardless of hematuria
16409908|NCT00804193|Drug|Ciclopirox Olamine Topical Suspension|topical suspension
16409909|NCT00804193|Drug|Ciclopirox Topical Suspension 0.77%-Reference Product|topical suspension
16409910|NCT00804193|Drug|Ciclopirox Olamine Topical Suspension-Placebo|topical suspension
16409911|NCT00799864|Drug|Rilpivirine|Patients will receive rilpivirine (RPV) tablet 25 milligram dose or an adjusted dose orally once daily in Cohort 1 (adolescents aged >=12 to <18 years) up to 240 weeks. Patients will receive RPV weight-adjusted dose orally once daily in Cohort 2 (children aged >=6 to <12 years) or 25 mg once daily for up to 48 weeks.
16409912|NCT00799864|Drug|Zidovudine|Type=exact, form= appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).
16409913|NCT00799864|Drug|Abacavir|Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).
16409914|NCT00799864|Drug|Tenofovir disoproxil fumarate|Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for 240 weeks (Cohort 1).
16409915|NCT00799864|Drug|Lamivudine|Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).
16409916|NCT00799864|Drug|Emtricitabine|Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).
16409919|NCT00324805|Biological|Bevacizumab|Given IV
16409920|NCT00324805|Drug|Cisplatin|Given IV
16409921|NCT00324805|Drug|Docetaxel|Given IV
16409922|NCT00324805|Drug|Gemcitabine Hydrochloride|Given IV
16409923|NCT00324805|Other|Laboratory Biomarker Analysis|Correlative studies
16409924|NCT00324805|Drug|Pemetrexed Disodium|Given IV
16409925|NCT00324805|Other|Questionnaire Administration|Ancillary studies
16409926|NCT00324805|Drug|Vinorelbine Tartrate|Given IV
16409927|NCT00278915|Drug|Fulvestrant|intramuscular injection
16409928|NCT00134056|Drug|atrasentan hydrochloride|Given orally
16409929|NCT00134056|Drug|docetaxel|Docetaxel given IV and prednisone given orally
16409930|NCT00134056|Drug|prednisone|Docetaxel given IV and prednisone given orally
16409931|NCT00134056|Other|placebo|Given orally
16409932|NCT00006669|Biological|rituximab|
16409933|NCT00006669|Biological|sargramostim|
16409934|NCT00006669|Drug|EPOCH regimen|
16409935|NCT00006669|Drug|cyclophosphamide|
16409936|NCT00006669|Drug|doxorubicin hydrochloride|
16409937|NCT00006669|Drug|etoposide|
16409938|NCT00006669|Drug|prednisone|
16409939|NCT00006669|Drug|vincristine sulfate|
16409940|NCT00000673|Drug|Ganciclovir|
16409941|NCT00000653|Drug|Zalcitabine|
16409942|NCT00000650|Drug|Ditiocarb sodium|
16409949|NCT00000647|Procedure|Bone marrow transplant|
16409950|NCT00000630|Biological|HIVAC-1e|
16409951|NCT00000630|Biological|gp160 Vaccine (MicroGeneSys)|
16409952|NCT00000626|Drug|Vinblastine sulfate|
16409953|NCT00000626|Drug|Dacarbazine|
16409954|NCT00000626|Drug|Filgrastim|
16409955|NCT00000626|Drug|Bleomycin sulfate|
16409956|NCT00000626|Drug|Doxorubicin hydrochloride|
16409957|NCT05098938|Drug|Acyclovir 50mg buccal tablet, BAYM008894/UI1614773|Oral (upper gum area), 50mg, 1 tablet.
16409958|NCT05098938|Drug|Placebo|Oral (upper gum area), 1 table.
16409959|NCT05098925|Other|Biological testing|Blood sampling, microcapillary sampling, temperature monitoring, saliva testing, EHI questionnaire
16409960|NCT05098912|Other|Manual acupuncture|Manual acupuncture using filiform needle
16409961|NCT05098912|Other|Thread embedding acupuncture|Thread Embedding acupuncture using Polydioxanone thread
16409962|NCT05098899|Genetic|MyGeneMyDiet® Recommendations for Weight Management|This group will receive Nutrition and Lifestyle recommendation based on SNPs known to have an impact to body weight and body composition, and responses to physical activity and dietary fat intake
16409963|NCT05098899|Other|Usual Standard of Care for Weight Management|This group will receive the conventional and standard nutrition lifestyle recommendation for weight management
16409964|NCT05098886|Drug|DA-5210 10/1000mg|single dose administration (one tablet once a day)
16409965|NCT05098886|Drug|DA-5210-R 10/1000mg|single dose administration (one tablet once a day)
16409966|NCT05098873|Other|psychodynamic|intervention with adolescents through the presentation of questions to be completed
16409967|NCT05098860|Other|Home Exercise Program|Educational training program includes active stretching, strengthening, and stabilization exercises of head and neck muscles as well as relaxation and breathing exercises.
16409968|NCT05098860|Other|Manual Therapy Combined with Home Exercise Program|Manual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae.
16409969|NCT05098860|Other|Tele-rehabilitation Assisted Program|Tele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.
16409970|NCT05098847|Drug|Sintilimab|Sintilimab plus lenvatinib will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks.
16409971|NCT05098847|Drug|Lenvatinib|Sintilimab plus lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) was given orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
16409972|NCT05098847|Drug|Cryoablation|Cryoablation treatment starts at day 0. Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
16409973|NCT05098834|Device|ENLIGHT 2100 ventilatory electrical impedance tomograph|The ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation.
16409974|NCT05098821|Other|not applicable, observational study|Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
16409975|NCT05098808|Other|Acoustic features (from signals obtained during phonation)|"Acoustic features will be obtained via phonation files.
~A voice recorder application provided by Apple was used, and the sampling frequency of the sound was 44,100 Hz. The digitized cough sound signals were band-pass-filtered between 20 to 16,000 Hz to use data from the whole frequency band gathered by the iPad. In each case, the smart device was positioned 20cm from the patient"
16409976|NCT05098795|Behavioral|Behavioral Activation (BA)|BA seeks to increase the positive reinforcement patients experience from their natural environment by promoting prosocial and valued experiences. BA has been found to improve substance use treatment retention and adherence, as well as medication adherence in low-income individuals with HIV/AIDS.
16409977|NCT05098756|Other|Art therapy|The art therapy in this study is once a week, 90 minutes each section for a total of 8-week, and using theme-oriented group art therapy. Each section has one theme, and the researcher guides the elderly to make artistic creations. Each section includes a warm-up phase is 15 minutes, the creative phase is 60 minutes, and sharing phase is 15 minutes.
16409980|NCT05098730|Behavioral|Strategy Training|Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.
16409981|NCT05098704|Drug|clopidogrel treatment|75 mg daily during 24 months
16409982|NCT05098704|Drug|Placebo|75 mg daily during 24 months
16409983|NCT05098691|Diagnostic Test|serum marker levels|two groups comparisons
16409984|NCT05098678|Dietary Supplement|Zinc gluconate|120 mg each tablet containing 30 mg elemental zinc
16409985|NCT05098678|Dietary Supplement|Placebo|Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
16409986|NCT05098665|Diagnostic Test|Telemonitoring|"A remote weight monitoring device (BodyTrace) will be delivered to the volunteers home and advice given where to place it ( on a hard surface) and how often to use it (daily, after waking and urination, but before breakfast).
~Arms 1 and 2a will receive the intervention."
16409987|NCT05098652|Behavioral|CuRB-IT|9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly
16409988|NCT05098639|Behavioral|BASICS|In the BASICS condition, individuals receive information about alcohol use on campus and discuss safe drinking practices. They also receive personalized normative feedback based on their alcohol use and their use of protective behavioral strategies.
16410018|NCT05098366|Drug|Normal saline|20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush
16410019|NCT05098353|Drug|Quetiapine|25-75 mg per day for 6 weeks
16409989|NCT05098639|Behavioral|Deviance Regulation Theory (DRT)|The Deviance Regulation Intervention comprises tailored intervention messages based on perceived norms. Participants complete an initial session that focuses on perceived norms of protective behavioral strategy (PBS) use and heavy drinking among peers. The therapist engages participants in a tailored discussion based on their perceived norms. If individuals believe PBS use is uncommon, the therapist discusses the positive social image that PBS use portrays. If the participant believes PBS is common, the therapist engages the participant in discussion of the negative aspects of non-PBS use. A similar strategy is taken for common and uncommon heavy alcohol use. Finally, the participant carries a mobile device which provide real-time adaptive positive or negative messages (consistent with the initial session) based on the perceived drinking and PBS norms of their current drinking environment.
16409990|NCT05098613|Drug|CD19x22 CAR T Cells|Autologous peripheral blood mononuclear cells transduced with CD19x22 CAR T lentiviral vector.
16409991|NCT05098600|Other|Exposure of interest|Common autoimmune and atopic conditions consist of atopic dermatitis, allergic rhinitis, asthma, Crohn's disease, ulcerative colitis, Celiac disease, Pernicious anaemia, Type 1 diabetes, Autoimmune thyroiditis (Hashimoto's thyroiditis, Grave's disease, atrophic, unspecified), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, Systemic lupus erythematosus, Sjogren syndrome, psoriasis, vitiligo, Multiple sclerosis
16409992|NCT05098574|Drug|Yaz|Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
16409993|NCT05098574|Drug|Placebo|Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
16409994|NCT05098561|Other|Music Treatment|The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.
16409995|NCT05098548|Procedure|angioplasty|using a balloon to stretch open a narrowed or blocked artery. However, most modern angioplasty procedures also involve inserting a short wire-mesh tube, called a stent, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely .
16409996|NCT05098535|Other|Visual Aid|"The visual aid will include a graphic display of 100 individuals with number of individuals anticipated to suffer a myocardial injury highlighted by being filled in in red. There will also be a textual description stating the anticipated risk.
~For example in a patient with an rCRI score = 2 the text will state 10 out of 100 patients will have a myocardial injury (MINS) and 90 out of 100 patients will have no myocardial injury and 10 of the patients will be shaded red on the visual aid. The patients in this intervention will also received the scripted discussion of perioperative risk of MINS."
16409997|NCT05098535|Other|Scripted Risk Discussion|The patients seen in PSS will have a standardized discussion of perioperative risk of myocardial injury read to them by the anesthesiologist in the PSS clinic.
16409998|NCT05098522|Drug|IRL201104|lyophilised powder for reconstitution for IV dosing
16409999|NCT05098522|Drug|Placebo|Matching placebo for IRL201104
16410000|NCT05098509|Drug|RAD011|Synthetic Cannabidiol Oral Solution
16410001|NCT05098509|Drug|Placebo|Placebo
16410002|NCT05098483|Procedure|Regeneration in primary molars by using MTA|Regenerative endodontic procedure in nonvital primary molars using MTA capping material
16410003|NCT05098483|Procedure|Regeneration in primary molars by using biodentine|Regenerative endodontic treatment in primary molars with biodentine as capping material
16410004|NCT05098483|Procedure|Conventional Root canal treatment in primary molars|Removal of pulp tissue from the canals of primary molars
16410005|NCT05098470|Drug|Metformin|1500-2000 mg per day for 8 weeks
16410006|NCT05098470|Drug|Insulin Glargine|Long-acting insulin for 8 weeks
16410007|NCT05098470|Drug|Dorzagliatin|Oral Glucokinase Activator 75 mg twice daily for 8 weeks
16410008|NCT05098457|Device|GP0112|Injectable gel
16410009|NCT05098457|Device|Restylane Lyft Lidocaine|Injectable gel
16410010|NCT05098444|Behavioral|Cognitive behavioral psychotherapy|Internet-based Cognitive Behavioural Therapy aims to reduce the impairment due to endometriosis by using cognitive behavioural intervention techniques. Furthermore, therapy should enable the patients in coping with symptoms in the future.
16410011|NCT05098444|Other|Waiting list|Participants of the waiting list receive no treatment for 5 months. Afterwards they receive the same treatment as the experimental group.
16410012|NCT05098431|Other|Quadriceps and Rectus Femoris MEP Recording|Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording
16410013|NCT05098418|Drug|Poison|standard of care and propre antidotes will be provided for each poisoned patients in addition to gastric lavage and activated charcoal administration when it is applicable
16410014|NCT05098405|Drug|MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate|"The study will start with dose-escalation cohorts to determine the recommended dose for expansion (RDE) or the maximum tolerated dose (MTD).
~Once the RDE (or MTD) has been determined, a safety expansion cohort will be opened and additional patients will be treated with MP0317 monotherapy at this dose to confirm safety in a larger population.
~Study treatment will be administered every 3 weeks (q3w) as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first. Treatment beyond PD will be allowed as per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)."
16410015|NCT05098392|Behavioral|Sibling-mediated intervention|Typically developing siblings will be trained to use an explicit instruction strategy (model-lead-test) and a checklist to self-monitor their teaching when working with their siblings with ASD on reading and social skills.
16410016|NCT05098379|Behavioral|Tele-Rehabilitation Home Exercise Program|"Participants will engage in 150 minutes of exercise per week (30 min/day for 5 days/week) for 8 weeks and will have weekly virtual Exercise Coaching sessions with a trained project team member. Customized home exercise programs will be reviewed weekly during the coaching sessions and will be modified as needed to ensure participants can complete their exercises safely and effectively. Exercise coaches will send weekly messages to 'check-in' with participants in order to motivate and remind participants to adhere to their tailored home exercise programs.
~During weekly exercise coaching sessions, exercises will be reviewed for form, safety, and progression. Exercises will be revised as needed to ensure that they are in line with participants' goals, needs, and preferences."
16410017|NCT05098366|Drug|Furosemide|0.1mg/kg (max 5mg) of IV furosemide
16410020|NCT05098340|Genetic|Quantitative Real-time polymerase chain reaction|Quantitative Real-time polymerase chain reaction of circular RNA (circRNA).
16410021|NCT05098327|Drug|Pioglitazone 30 mg|pioglitazone 30 mg dose 1 tab daily will be given for 12 weeks
16410022|NCT05098327|Drug|Placebo|placebo pills containing cellulose 1 pill daily will be given for 12 weeks
16410023|NCT05098314|Other|Personalized interventions regarding the Cicat-Occitanie network|"First of all, healthcare professionals from EHPAD in the intervention arm were invited by email to answer a closed questionnaire. It was built by the authors, on Google forms, and consisted of 11 questions divided into 2 sections.
~Section 1 collected data about the participants. In section 2, they were asked to score from 0 to 4 (ranging from not at all to a lot ) the various obstacles to teleconsultations reported by the literature."
16410024|NCT05098288|Behavioral|Multicentre Pain Monitor + Unified Protocol|The intervention will consist in a self-applied online transdiagnostic intervention for emotional problems together with an app-based EMA. In terms of monitoring, the Multicentre Pain Monitor is a mobile app whose contents have been adapted to conduct ecological momentary assessments in different health conditions. The app assesses important psychological variables, namely anxiety, depressive symptoms,etc. Participants respond daily to the questions in the app. In terms of the online self-applied intervention, the Unified Protocol is a transdiagnostic extension of CBT which works on regulate emotions in a more adaptive way through 5 core treatment modules: present-focused emotional awareness, cognitive flexibility, identification and prevention of emotional avoidance patterns, increasing awareness and tolerance to emotion-elicited physical sensations, and graded (interoceptive and situational) exposure procedures.
16410025|NCT05098275|Drug|DA-5210 10/500mg|single dose administration (one tablet once a day)
16410026|NCT05098275|Drug|DA-5210-R 10/500mg|single dose administration (one tablet once a day)
16410027|NCT05098262|Drug|DA-5210 10/500mg|single dose administration (one tablet once a day)
16410028|NCT05098262|Drug|DA-5210-R 10/500mg|single dose administration (one tablet once a day)
16410029|NCT05098249|Drug|Verum|The participant takes two capsules Phoscap® (3mmol/capsule) orally three times a day over 30 days beginning the day of Ferinject administration.
16410030|NCT05098249|Drug|Placebo|The participant takes wo capsules Placebo orally three times a day over 30 days beginning the day of Ferinject administration.
16410031|NCT05098236|Device|Training in the Blind Field|A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. Subjects will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 3 and up to 12 months at a time.
16410032|NCT05098236|Device|Training in the Sighted Field|This training will take place in lab at the University of Rochester Medical Center. Subject will perform one daily training session, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) located at a predetermined location in the visual field. The computer program will automatically create a record of patient performance during each training session. Subjects will train daily (about 30-40 minutes total), 5 to 7 days per week for at 7 - 14 days.
16410033|NCT05098223|Behavioral|Intervention to remove price promotions on unhealthy foods when online shopping|Removal of price promotions on unhealthy foods
16410034|NCT05098210|Biological|Neoantigen Peptide Vaccine|Given IM
16410035|NCT05098210|Biological|Nivolumab|Given IV
16410036|NCT05098210|Drug|Poly ICLC|Given IM
16410037|NCT05098197|Biological|Tumor Infiltrating Lymphocyte|Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.
16410038|NCT05098184|Biological|Tumor Infiltrating Lymphocyte|Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.
16410039|NCT05098171|Biological|Signal Switch Receptor Modified TIL|Adoptive transfer of 2x10^8-1x10^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes.
16410040|NCT05098158|Other|Non-pharmacological pain treatment|Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
16410041|NCT05098145|Biological|FCR001|Enriched hematopoietic stem cell infusion
16410042|NCT05098132|Drug|STK-012|pegylated alpha/beta-biased engineered interleukin-2
16410043|NCT05098132|Drug|Pembrolizumab|anti-PD-1 humanized monoclonal antibody
16410044|NCT05098119|Drug|Sintilimab, Nab-paclitaxel, Carboplatin|Neoadjuvant Therapy
16410045|NCT05098119|Procedure|Surgical resection|Standard of care
16410046|NCT05098119|Drug|Sintilimab|Adjuvant Therapy
16410047|NCT05098106|Diagnostic Test|Bronchoscopy, blood sampling; testing.|BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.
16410048|NCT05098093|Dietary Supplement|SBE|Hard-shell capsule
16410049|NCT05098093|Dietary Supplement|DBE|Hard-shell capsule
16410050|NCT05098093|Dietary Supplement|BP|Hard-shell capsule
16410051|NCT05098080|Biological|HutrukinTM|HutrukinTM that binds the human cytokine IL-1α with high affinity and is an effective blocker of IL-1α biological activity. HutrukinTM is a True Human™ therapeutic antibody. That is, the antibody was generated by a natural human immune response and was cloned directly from a human peripheral B lymphocyte. No in vitro affinity maturation or modifications have been made to improve its natural binding affinity. A true human antibody should be effectively non-immunogenic in humans and thus exhibit optimal activity and pharmacokinetics indistinguishable from native IgG1 immunoglobulin.
16410052|NCT05098067|Drug|Capsaicin Topical Cream|5g 0.075% applied once
16410053|NCT05098067|Drug|Metoclopramide|10mg IV once
16410054|NCT05098067|Drug|Ondansetron|8mg IV once if needed
16410055|NCT05098067|Drug|Lactated Ringers, Intravenous|1000cc once
16410056|NCT05098054|Drug|Soticlestat|Soticlestat tablets.
16410057|NCT05098041|Drug|Soticlestat|Soticlestat tablets.
16410058|NCT05098041|Drug|Rifampin|Rifampin capsules.
16410059|NCT05098028|Drug|Low Dose Rifaximin ER|Low Dose Rifaximin Extended Release Twice Daily
16410060|NCT05098028|Drug|Low Dose Rifaximin DER|Low Dose Rifaximin Delayed Extended Release Twice Daily
16410061|NCT05098028|Drug|High Dose Rifaximin ER|High Dose Rifaximin Extended Release Twice Daily
16410062|NCT05098028|Drug|High Dose Rifaximin DER|High Dose Rifaximin Delayed Extended Release Twice Daily
16410063|NCT05098028|Drug|Placebo|Placebo Twice Daily
16410064|NCT05098015|Behavioral|Game Changers|8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.
16410065|NCT05098002|Behavioral|Mindfulness program|6 week class designed to improve psychological well-being
16410066|NCT05097989|Drug|ALXN2050|Oral tablets
16410067|NCT05097989|Drug|Placebo|Oral tablets
16410068|NCT05097976|Drug|Methylprednisolone|21 x 4mg tablets beginning on POD 1
16410069|NCT05097976|Drug|Placebo|21 sugar tablets beginning on POD 1 with standard management
16410070|NCT05097963|Device|Endoscopic Ultrasound Shear Wave Elastography|Software to determine stiffness of liver for evaluating liver fibrosis.
16410071|NCT05097950|Drug|Administration of 1 gr paracetamol I.V|Administration of 1 gr paracetamol I.V
16410072|NCT05097937|Other|Sham intervention|The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.
16410073|NCT05097937|Other|Low intensity percutaneous electrolysis|A single impact of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 0.3 mA for 90 seconds.
16410074|NCT05097937|Other|High intensity percutaneous electrolysis|Three impacts of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 3 mA and a duration of 3 seconds each.
16410075|NCT05097924|Other|NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format|Post-market observational study with formula feeding administered via standard of care
16410076|NCT05097911|Drug|MTL-CEBPA|The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.
16410077|NCT05097911|Drug|Atezolizumab|The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.
16410078|NCT05097911|Drug|Bevacizumab|The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.
16410079|NCT05097898|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion (including the EVEREST score) will be performed during day hospitalization
16410080|NCT05097898|Procedure|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional
16410081|NCT05097898|Procedure|Blood sample retrieved for biological assessment and biobanking|Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization
16410082|NCT05097898|Other|Telephone follow-up|Telephone follow-up will be performed 3, 12 and 24
16410083|NCT05097885|Other|Sub Acute Whole Body Vibration Training|Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and/or reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and/or reduce the duration of rest.
16410084|NCT05097872|Other|Diet|Diet excluding either trigger and sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
16410085|NCT05097846|Drug|Group1 Vonoprazan Fumarate + amoxicillin + doxycycline|Vonoprazan Fumarate + amoxicillin + doxycycline
16410086|NCT05097846|Drug|Group2 Vonoprazan Fumarate + furazolidone + doxycycline|Vonoprazan Fumarate + furazolidone + doxycycline
16410087|NCT05097846|Drug|Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline|esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
16410088|NCT05097846|Drug|Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline|esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
16410089|NCT05097833|Behavioral|Enhanced Saint Francis Fatherhood FIRE Program|Fathers receive an enhanced series of pro-parenting, relationship, and economic stability workshops over 16 weeks. Workshop series are based on a diverse curricula including a combination of either 24/7 Dad or Parent Project and Connections to Success and the Nurturing Fathers enhancement program.
16410090|NCT05097833|Behavioral|Services as Usual Saint Francis Fatherhood FIRE Program|Fathers receive the services as usual approach which includes a series of pro-parenting, relationship, and economic stability workshops over 13 weeks. Workshop series are based on a diverse curricula including a combination of either 24/7 Dad or Parent Project and Connections to Success.
16410091|NCT05097820|Device|Placement of testicular prosthesis|The surgical implantation of one or two testicular prostheses on request of the patient
16410092|NCT05097807|Behavioral|smartphone related behaviors|Participants are required to watch specific contents on their own smartphones.
16410093|NCT05097794|Drug|BR1015-1|- Administration to the BR1015-1 group: 60 mg of BR1015-1 will be administered one tablet once a day, five-day repeated doses.
16410094|NCT05097794|Drug|BR1015-2|- Administration to the BR1015-2 group: 1.5 mg of BR1015-2 will be administered one tablet once a day, five-day repeated doses.
16410095|NCT05097794|Drug|BR1015-1 + BR1015-2|- Co-administration to the BR1015-1+BR1015-2 group: 60 mg of BR1015-1 one tablet and 1.5 mg of BR1015-2 one tablet will be co-administered once a day, five-day repeated doses.
16410096|NCT05097781|Drug|PD-1 blocking antibody|All patients with more than one distant metastatic lesions will accept at least one site of radiotherapy and PD-1 blockade at the same time.
16410097|NCT05097768|Drug|Dexamethasone 0.5mg|The patients will be randomly given the medication by mouth 60 min before administering IANB.
16410098|NCT05097768|Drug|Ketorolac 10 Mg Oral Tablet|The patients will be randomly given the medication by mouth 60 min before administering IANB.
16410099|NCT05097768|Drug|Meloxicam 7.5 mg|The patients will be randomly given the medication by mouth 60 min before administering IANB.
16410100|NCT05097768|Drug|Ibuprofen 600 mg|The patients will be randomly given the medication by mouth 60 min before administering IANB.
16410101|NCT05097768|Drug|Placebo|The patients will be randomly given the medication by mouth 60 min before administering IANB.
16410102|NCT05097729|Device|Transcranial Magnetic Stimulation|The brain stimulation can be delivery using different devices; in this project a MagPro X100 stimulator connected to a MagPro Cool-B65 liquid-cooled butterfly coil (MagVenture A/S, Farum, Denmark) will be used. Resting motor threshold (M1-rTMS) will be determined during the visit 1 or visit 2 and used along all visits. The rTMS pulse sequences and intensities used are all within the published safety guidelines
16410103|NCT05097716|Drug|Ritlecitinib|Ritlecitinib 200 mg provided as four 50 mg oral capsules
16410104|NCT05097716|Drug|Tolbutamide|Tolbutamide 500 mg provided as one 500 mg oral tablet
16410105|NCT05097703|Behavioral|Sleep Resource|The sleep resource is a card game to be played by children and caregivers as part of their bedtime routine. It includes exercised to help prepare the child for sleep, including deep breathing, mindfulness and light movement. Caregivers will be asked to use the resource for a minimum of three nights a week over a four week period, and complete pre and post outcome measures as well as sleep and resource use diaries for their children
16410106|NCT05097677|Other|Not applicable (observational study)|Not applicable (observational study)
16410107|NCT05097651|Drug|Cannabidiol oral solution|Cannabidiol 100mg/mL in a sesame seed oil, strawberry flavored solution, taken orally at bedtime in self-titrated dose between 50mg and 600mg. Once a dose that results in relief of symptoms is reached, it will remain as the maintenance dose, not to exceed 600mg.
16410108|NCT05097651|Drug|Inert sesame seed oil|Placebo will be identical strawberry flavored sesame seed oil-based solution without CBD.
16410109|NCT05097638|Diagnostic Test|spirometry|Patient do spirometry
16410110|NCT05097612|Device|Placebo LiftSuit Exoskeleton|The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). In this condition the EES are removed from the device to create a placebo device.
16410111|NCT05097612|Device|LiftSuit Exoskeleton (low support level)|The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.
16410112|NCT05097612|Device|LiftSuit Exoskeleton (medium support level)|The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.
16410113|NCT05097612|Device|LiftSuit Exoskeleton (high support level)|The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.
16410114|NCT05097599|Drug|Lorlatinib|This arm of the Strata PATH trial will assess the clinical benefit of lorlatinib in ALK and ROS1 gene fusion positive solid tumors with the exception of NSCLC.
16410115|NCT05097599|Drug|Encorafenib + Binimetinib|This arm of the Strata PATH trial will assess the clinical benefit of encorafenib plus binimetinib in BRAF p.v600X mutated solid tumors with the exception of melanoma and colorectal cancer.
16410116|NCT05097599|Drug|Talazoparib|This arm of the Strata PATH trial will assess the clinical benefit of talazoparib in patients with advanced solid tumors harboring deep deletions or deleterious mutations with LOH in BRCA1/2 and PALB2, excluding HER2 negative breast cancer.
16410117|NCT05097599|Drug|Enhertu|This arm of the Strata PATH trial will assess the clinical benefit of Enhertu in patients with advanced solid tumors harboring HER2 over-expression as detected by StrataEXP.
16410118|NCT05097599|Drug|PADCEV|This arm of the StrataPATH trial will assess the clinical benefit of enfortumab in patients with advanced solid tumors harboring Nectin-4 over-expression as detected by StrataEXP.
16410119|NCT05097586|Device|active tDCS|2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
16410120|NCT05097586|Other|workbook|Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
16410121|NCT05097586|Device|sham tDCS|Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks
16410122|NCT05097573|Device|Venus Viva|The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, stretch marks, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
16410123|NCT05097560|Device|high flow nasal cannula|HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.
16410124|NCT05097560|Device|Venturi mask|VM is commonly used by COPD patients during exercise training.
16410125|NCT05097547|Behavioral|Contingency Management|Contingency management involves receiving monetary prizes in exchange for negative urine drug screens.
16410126|NCT05097534|Other|iDSMES|Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
16410127|NCT05097534|Other|Standard of Care|Standard of Care for patients with type 2 diabetes
16410128|NCT05097521|Other|Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings|Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings
16410129|NCT05097521|Other|Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings|Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings
16410130|NCT05097521|Other|Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings|Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings
16410131|NCT05097508|Drug|Atracurium Besylate|Anesthesia will be induced by atracurium (dose 0.5 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Atracurium (dose 0.005-0.01 mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery. In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure. In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given
16410132|NCT05097508|Drug|Rocuronium Bromide|Anesthesia will be induced by rocuronium (dose 0.6 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Rocuronium (dose 0.01-0.012 mg/kg/min ) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery. In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure. In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given.
16410133|NCT05097508|Device|Entropy|No premedication will be given. After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system , starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
16410134|NCT05097508|Device|train of four|After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system, starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
16410135|NCT05097495|Procedure|Only NNS|"Before the procedure, the Premature Infant Comfort Scale shall be filled out.
~Procedure steps for the control group:
~Materials shall be prepared (napkins, non-sterile gloves, pacifier)
~Hands shall be washed; gloves shall be worn.
~The infant shall be given a NNS just before the procedure and continue until the 5th minute after the procedure.
~The diapers shall be changed.
~Hands shall be washed after the procedure.
~The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure."
16410136|NCT05097495|Procedure|NNS Combined with Breast Milk|"Before the procedure, the Premature Infant Comfort Scale shall be filled out.
~Materials shall be prepared (napkins, non-sterile gloves, pacifier, breast milk, cup)
~Hands shall be washed; gloves shall be worn.
~The cylindrical part of a pacifier shall be in touch with breast milk for 5 seconds. The infant shall be given the pacifier, combined with breast milk, just before the procedure and continue until the 5th minute after the procedure.
~The diapers shall be changed.
~Hands shall be washed after the procedure.
~The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure."
16410137|NCT05097469|Device|Carbon dioxide laser|3 consecutive sessions of carbon dioxide laser treatment
16410138|NCT05097469|Device|Sham laser treatment|3 consecutive sessions of sham laser treatment
16410139|NCT05097456|Device|carbon dioxide laser|carbon dioxide laser
16410140|NCT05097456|Device|sham laser|sham laser
16410141|NCT05097443|Drug|Orelabrutinib+R-CHOP; Orelabrutinib+R-DA-EPOCH; Orelabrutinib+R-HD MTX|"Orelabrutinib+R-CHOP Regimen： Orelabrutinib：150mg qd； R-CHOP：Rituximab 375mg/m2 d0, Cyclophosphamide 750mg /m2 d1, Doxorubicin 50mg /m2 or Doxorubicin liposome 30-40 mg /m2 d1, Vincristine 1.4mg /m2 or Vindesine 3mg /m2 d1, Prednisone 100mg d1-5. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy.
~Orelabrutinib+R-DA-EPOCH Regimen： Orelabrutinib：150mg qd； R-DA-EPOCH：Rituximab 375mg/m2 d0, Etoposide 50mg/ m2, Epirubicin 15mg/ m2, Vincristine 0.4mg/ m2, d1-4, Cyclophosphamide (CTX) 750mg/ m2 d5, Prednisone 60mg/ m2 d1-5. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy.
~Orelabrutinib+R-HD MTX Regimen： Orelabrutinib：150mg qd； R-HD MTX：Rituximab 375mg/m2 d0, Methotrexate 3.5g/ｍ2 d1. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy."
16410142|NCT05097443|Drug|R-CHOP; R-DA-EPOCH; R-HD MTX|"R-CHOP Regimen： Rituximab 375mg/m2 d0, Cyclophosphamide 750mg /m2 d1, Doxorubicin 50mg /m2 or Doxorubicin liposome 30-40 mg /m2 d1, Vincristine 1.4mg /m2 or Vindesine 3mg /m2 d1, Prednisone 100mg d1-5. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy.
~R-DA-EPOCH Regimen： Rituximab 375mg/m2 d0, Etoposide 50mg/ m2, Epirubicin 15mg/ m2, Vincristine 0.4mg/ m2, d1-4, Cyclophosphamide 750mg/ m2 d5, Prednisone 60mg/ m2 d1-5. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy.
~R-HD MTX Regimen： Rituximab 375mg/m2 d0, Methotrexate 3.5g/ｍ2 d1. Every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance to chemotherapy."
16410435|NCT04984616|Drug|Placebo|Oral administration of Placebo daily for 120 days
16410143|NCT05097430|Behavioral|Alcohol-focused brief intervention|The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns.
16410144|NCT05097417|Combination Product|traditional Chinese medicine and ablation in the primary tumor sites|Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites
16410145|NCT05097417|Procedure|ablation|Patients will be treated with ablation in the primary tumor sites
16410146|NCT05097391|Behavioral|Warm-up (5 minutes)|Participants will benefit from passive stretches of hamstrings, calf muscles including a range of motion (ROM) exercise to the lower limbs as mat exercises.
16410147|NCT05097391|Behavioral|Conventional physiotherapy exercise (15 minutes)|The conventional treatments will be active-assisted and free active exercises to the lower limbs on the mat for five (5) minutes. This will be followed by strength training such as sit-to-stand exercises for five (5) minutes and squatting exercises for five (5) minutes prior to the over-ground training.
16410148|NCT05097391|Behavioral|Over-ground training with lower limb loading (15-25 minutes)|"Participants will perform the over-ground training exercise with an external 1.5kg load on the paretic lower limb placed 2cm above the ankle joint. Before commencing the over-ground training, all the participants will observe a pre-exercise rest period of about two (2) minutes during which their heart rate and blood pressure measurements will be recorded.
~The over-ground training will involve the patients walking within a demarcated path. Each participant will be instructed to stand and walk 15meters to and fro for five (5) minutes after which they will be asked to stop and rest for two (2) minutes. The over ground training exercise will be repeated 3 times in the first 2 weeks of the training (15 minutes); 4 times in weeks 3-4 of the training (20 minutes); and 5 times in weeks 5-8 of the training (25 minutes)."
16410149|NCT05097378|Drug|Encorafenib + Binimetinib|"Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor, which suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K).
~Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity"
16410150|NCT05097378|Drug|Standard Adjuvant Treatment|Standard Adjuvant Treatment
16410151|NCT05097365|Dietary Supplement|Vitamin B12 + folic acid supplementation|A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a vitamin B12 and folic acid supplementation, in addition to the usual therapy. The dietary supplementation will be by capsules, which will content 400 mcg of folic acid and 2000 mcg of vitamin B12 each.
16410152|NCT05097365|Dietary Supplement|Placebo supplementation|A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a placebo supplementation.The placebo and vitamin B12 + folic acid supplement will be indistinguishable in terms of taste, smell, and appearance.
16410153|NCT05097352|Behavioral|High Intensity Interval Training (HIIT)|Twenty minutes of HIIT will be completed three days a week for six weeks.
16410154|NCT05097352|Other|Waitlist|Waitlist participants will be tested on the outcomes at the same time points as the treatment group.
16410155|NCT05097326|Drug|Mifepristone|Mifepristone 200mg taken orally
16410156|NCT05097326|Drug|Placebo|Placebo to match mifepristone taken orally
16410157|NCT05097313|Dietary Supplement|Yeast β-glucan fiber|The study is designed to determine if β-glucan is safe and if it presents an antioxidant and immunomodulatory response in healthy adults in Colombia.
16410158|NCT05097313|Other|Placebo|oral consumption of 200 mg (one capsule) or 400 mg (two capsules) of soy protein powder for 84 days.
16410159|NCT05097300|Other|Suboccipital inhibition|The therapist will place his hands under the patient's head, making contact with the suboccipital muscles in the region of the posterior arch of the atlas, applying progressive and deep pressure. This pressure will be maintained for 10 minutes
16410160|NCT05097300|Other|Ischemic pressure|"Pressures will be made on the temporal, superior trapezius, masseter and sternocleidomastoid muscles. Physical therapist will apply gradual sustained finger pressure to the muscle's active trigger points for 5-15 seconds. The therapist will begin with light firm pressure and gradually increase the pressure until the patient feels a moderate but bearable level of pain (corresponding to a level 7 on a pain scale of 1 to 10 levels where 1 indicates no pain and 10 is excruciating pain). Pressure will remain at this level until pain levels decrease to level 3. The therapist will repeat this procedure approximately 3-4 times over a 90 second period."
16410161|NCT05097300|Other|Passive stretching|Passive stretches will be applied to each muscle 2 times for 30 seconds, they will be performed slowly at the rate of the patient's normal breathing and checking that no compensations appear.
16410162|NCT05097300|Other|Diaphragmatic breathing exercice|To perform diaphragmatic breaths, there will first be an education on how to do them. The patient will lie supine, with the hips and knees semi-flexed. The therapist will ask you to place one hand on your chest and one on your abdomen. Successively, it will ask you to take a few deep breaths, inhaling through your nose for 2 seconds and exhaling through your mouth, with your lips pursed (almost closed) for 4 seconds, helping you to maintain the rhythm of your breath by counting out loud. The patient should note that during inspiration his hand on top of the chest does not rise (the chest remains still) and during expiration that his hand on top of the abdomen goes down (the abdomen sinks).
16410163|NCT05097287|Drug|Dupilumab|solution for injection subcutaneous
16410164|NCT05097287|Drug|Placebo|solution for injection subcutaneous
16410165|NCT05097274|Other|MRI pelvis or CT imaging|Individuals to undergo a MRI or CT scan of Pelvis
16410166|NCT05097274|Other|Whole body bone scan imaging|bone scan of the whole body.
16410167|NCT05097274|Other|FCH-PET-CT imaging|
16410168|NCT05097261|Drug|Ketamine|Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h.
16410169|NCT05097261|Drug|Placebo|Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).
16410170|NCT05097248|Drug|Camrelizumab|Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
16410171|NCT05097248|Drug|Liposomal Doxorubicin|Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.
16410172|NCT05097248|Drug|Losartan|Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy
16410173|NCT05097222|Device|BioFlex Dualport System|The device consists of a laptop computer preprogrammed with the Bioflex® Practitioner+ Software, the Bioflex® DUO 180+ array pad that has 180 bicolour Light Emitting Diodes (LED) that emit red and near infrared light, and two laser probes, the LD-R 100 that emits red light, and the LD-I 200 that emits near infrared light.
16410174|NCT05097222|Device|Sham device|Control
16410175|NCT05097209|Drug|Camrelizumab|Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.
16410176|NCT05097209|Drug|Gemcitabine|Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation
16410177|NCT05097209|Drug|Induction Cisplatin|Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
16410178|NCT05097209|Radiation|intensity-modulated radiotherapy|Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
16410179|NCT05097209|Drug|Concurrent cisplatin|Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
16410180|NCT05097196|Other|Moderate-intensity aerobic activities|The exercise intensity of the individual is planned at 50-60% heart rate reserve using the Karvonen method.
16410181|NCT05097183|Procedure|Accurate Commissural Alignment (ACA)|Software based, computed tomography analysis that allows planification of accurate commissural alignment of TAVR by inserting the delivery system in a patient-specific degree of rotation.
16410182|NCT05097170|Procedure|NIRS during ventricular tachycardia ablation|"NIRS: Near-infrared spectroscopy is a measurement technique that non-invasively and continuously monitors the balance between cerebral oxygen consumption and delivery.
~BIS: BIS is an electroencephalogram-derived parameter developed to monitor the hypnotic effects of anesthesia."
16410183|NCT05097157|Device|Potenza|Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.
16410184|NCT05097144|Device|Lens A (Test)|Test toric lens A
16410185|NCT05097144|Device|Lens B (control)|Control toric lens B
16410187|NCT05093842|Behavioral|Sedentary Behavior Reduction|Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
16410188|NCT05093842|Behavioral|Information on Physical Activity Recommendations during Pregnancy|Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
16410189|NCT05093816|Behavioral|Common Elements Toolbox|The Common Elements Toolbox (COMET) is an online single-session intervention. It is entirely self-guided and lasts about 60 minutes. Participants complete a series of reading and writing exercises focused on four modules: cognitive restructuring, behavioral activation, gratitude, and self-compassion. The intervention is entirely unguided and completed in a single sitting.
16410192|NCT05092269|Drug|Ustekinumab|Ustekinumab will be administered as a SC injection.
16410193|NCT05091645|Other|GFI|Two trained raters who will be blinded and will have no access to each other's evaluation, will administer the GFI questionnaire within 24 hours of patients' hospital admission.
16410194|NCT05090280|Drug|PF614 solution|PF614 solution is an oxycodone prodrug
16410195|NCT05090280|Drug|Naltrexone Hydrochloride|Naltrexone 50 mg has been selected to be administered on Day -1 (single dose), Day 1 (BID), and Day 2 (single-dose) to reduce opioid-related adverse effects.
16410196|NCT05090280|Drug|Nafamostat Mesylate|Maximum dose of 10 mg nafamostat co-administered with PF614 solution. Nafamostat will be dosed as an immediate-release (IR) solution or as prototype extended-release (ER) capsules.
16410197|NCT05089851|Procedure|Onabotulinumtoxin A|Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
16410198|NCT05089851|Combination Product|Facial Cleanser|Facial Cleanser to be used by participants twice daily
16410199|NCT05089851|Combination Product|Facial Moisturizer|Bland moisturizer to be used by study participants after serum twice daily.
16410200|NCT05089851|Combination Product|Sunscreen|Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.
16410224|NCT05085600|Other|Exercise|"Patients will begin performing the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
~In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
~The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side."
16410456|NCT04960202|Drug|Placebo|Placebo (tablet or capsule)
16410646|NCT04802811|Drug|SHR2150；Placebo|Single dose；SHR2150-dose 2 or Placebo-dose 2
16410201|NCT05089799|Behavioral|Exposure and interaction with a socially assistive robot|"Description of scenarios involving robot and users
~welcoming patients and family members l: the robot explains its own functionalities and answers persons 'questions.
~providing a reminder about sanitary gestures (prevention of virus transmission). In addition, it could mediate a conversation between two or more people so that they keep the appropriate physical distance between them.
~providing patients with an assistance to prepare the medical consultations : the robot helps patients to fill in paper forms for professionals. The robot also provides information on the course of consultations and the users 'rights in the hospital.
~providing orientation and guidance to the consultation rooms and the available services : the robot helps people to find their way around the hospital.
~Providing entertainment to patients and families during the waiting time: the robot offers activities to patients and caregivers"
16410202|NCT05089786|Device|Exablate Neuro Type 1.0 System with Echo Focusing|MR-Guided Focused Ultrasound
16410203|NCT05089370|Combination Product|Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab|Activation of the RIG-I innate immune pathway and increased expression of tumor antigens and pro-immune genes during Nivolumab treatment may enhance the frequency and activity of anti-tumor immune cells (CD4+ and CD8+ T-cells, NK cells) and reduce the frequency and activity of immunosuppressive cells (MDSCs, Tregs) (1-4), increasing the overall effectiveness and success of Nivolumab treatment. This pilot clinical trial will demonstrate whether combinatorial immunotherapeutic approaches that target epigenetic immune repression and RIG-I activity can favorably alter the tumor immune cell microenvironment and benefit mucosal melanoma patients.
16410204|NCT05089305|Drug|Ozone plasma|Patients will be provided with an ion-laden cold atmospheric plasma administration equipment from the company Fulgur Vitae Model 9000, they will also be given the necessary indications, as well as recommendations on the use of the equipment, which they must use for 5 minutes three consecutive times a day, every 6 hours, for two weeks. They will also be provided with an atmospheric oxygen meter, with the indication to keep the ppb below 0.07. You must record in your diary the start time, end and eventualities (in case of presenting them).
16410205|NCT05088395|Other|Blood sample|Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples taken per patient for up to 18 months.
16410206|NCT05088395|Other|Biopsy|If a specific tumor sample is required, it will be collected only once during the study
16410207|NCT05088109|Diagnostic Test|early mortality prediction using septic shock indices|The Shock Index (SI) is the ratio of pulse rate to systolic blood pressure calculated by dividing pulse rate (beat/min) by systolic blood pressure (mm Hg). The adjusted shock index (ASI) is SI calculated after adjusting the heart rate according to body temperature that 10 beats will be added to the heart rate for every 1.0 °C rise in the body temperature above 37.0 °C. The modified shock index (MSI) is a ratio of heart rate to mean blood pressure (MAP). The DSI is a ratio of heart rate to diastolic blood pressure (DAP).
16410208|NCT05087940|Drug|Add-on therapy|Add-on drugs prescribed by internal medicine specialists within the routine health care and independently from the study investigators - one of the following: an aldosterone receptor blocker, a loop diuretic, a thiazide in large daily dose, an alpha 1 selective blocker or a beta 1 selective blocker
16410209|NCT05087875|Behavioral|TRAC: Tracking and Reducing Alcohol Consumption|The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. Participants set goals for reducing their drinking and learn strategies to help them achieve those goals. It requires eight 30-minute sessions with a counselor using mobile phones.
16410210|NCT05087875|Other|No intervention|The comparison group will be evaluated based on daily self-monitoring data.
16410211|NCT05087576|Behavioral|Expressive Helping|Expressive helping integrates two distinct areas of research showing that emotional disclosure over writing and support giving improves psychological well-being among healthy and clinical populations. Participants write 4 brief structured writing sessions.
16410212|NCT05087576|Behavioral|Caregiving Fact writing|Factual Writing has been used with in other writing-based interventions (e.g., expressive writing). It is also completed in 4 brief structured writing sessions.
16410213|NCT05087524|Diagnostic Test|BinaxNOW Ag Card|A nasal swab specimen is collected from the participant, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The participant sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines.
16410214|NCT05087407|Procedure|Decomprssion and drainage seton|Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
16410215|NCT05087407|Procedure|Cutting seton|Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
16410216|NCT05086939|Drug|Autologous MSCs|Intra-articular injection 40 million/4 ml.
16410217|NCT05086939|Drug|Allogenic MSCs|Intra-articular injection 40 million/4 ml.
16410218|NCT05086939|Drug|Hyaluronic Acid|Intra-articular injection 60mg / 3 ml .
16410219|NCT05086562|Other|observation study|observation study
16410220|NCT05086198|Behavioral|Mindfulness-based intervention|An instructor trained in Mindfulness-based Stress Reduction (MBSR; Kabat-Zinn, 1990) will conduct meditations lasting 15 to 30 minutes. The participants will have a mobile application designed ad hoc with the practice of the week so they can do it individually at home.
16410221|NCT05086198|Behavioral|Physical exercise|An aerobic and fitness trainer will conduct aerobic exercise lasting 15 to 30 minutes. The participants will watch it in a video platform. They will not be able to do anaerobic exercise like weight lifting. The intensity of the chosen exercise will be moderate, maintaining between 120-140 beats per minute.
16410222|NCT05086003|Combination Product|Combined kidney and bone marrow transplantation|Combined kidney and bone marrow transplantation
16410223|NCT05085730|Device|InMode Morpheus8 System|The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.
16410283|NCT05062460|Other|1 hour Blood glucose monitoring|Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
16410225|NCT05085600|Other|Manual Therapy + Exercise|20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise
16410226|NCT05085366|Biological|mRNA-1647|Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
16410227|NCT05085366|Biological|Placebo|0.9% sodium chloride (normal saline) injection
16410228|NCT05084664|Device|electrical stimulation|premodulated current+ exercises
16410229|NCT05084664|Device|electrical stimulation|diadynamic current+ exercises
16410230|NCT05084131|Other|Use of an online questionnaire as follow-up after abdominal colorectal surgery|Patients were asked to complete a questionnaire via the institutional patient portal. Participants were also asked to upload a photo of their respective incisions. Participants then had an in-person follow-up visit.
16410231|NCT05083585|Biological|Ad26.RSV.preF-based vaccine|Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
16410232|NCT05083559|Device|MPC AP algorithm|The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM.
16410233|NCT05083559|Device|Robust R-AP algorithm|The R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system.
16410234|NCT05083325|Drug|Oseltamivir 75mg Test Drug capsules|Investigational Medicinal Product
16410235|NCT05083325|Drug|Oseltamivir 75mg capsules Reference Product capsules|Tamiflu (Roche Pharma (Switzerland) AG, Basel)
16410236|NCT05082766|Drug|enhanced DefenAge 8-in-1 BioSerum|DefenAge is a topical skincare brand containing a composition of biologically active natural molecules, named defensins, that repair skin damage associated with aging.
16410237|NCT05082285|Combination Product|MenABCWY-2Gen low dose vaccine|MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.
16410238|NCT05082285|Combination Product|MenABCWY-2Gen high dose vaccine|MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.
16410239|NCT05082285|Combination Product|MenABCWY-1Gen vaccine|MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.
16410240|NCT05082285|Combination Product|MenB vaccine|MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.
16410241|NCT05082285|Combination Product|MenACWY-TT vaccine|MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.
16410242|NCT05082090|Procedure|Spinal Surgery|Implanted with Orthofix Spinal Products (i.e. M6-C and M6-L disc, etc..)
16410243|NCT05081843|Behavioral|AD IT UP media literacy intervention|AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
16410244|NCT05081843|Behavioral|Usual health education curriculum|The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
16410245|NCT05081206|Drug|Propofol infusion via manually controlled pump.|Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.
16410246|NCT05081206|Drug|Propofol infusion via target controlled pump.|Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.
16410247|NCT05080504|Device|Eko DUO|"Each subject will take an Eko DUO device home and take DUO recordings immediately before or after their prescribed CardioMEMS measurements.
~The DUO recordings will be taken at 3 predefined chest locations: the right upper sternal border, left upper sternal border, and right anterolateral. Each DUO recording lasts about 15 seconds. The total time per recording session is expected to be 2-4 minutes, which allows for time between recordings and any potential repeat recordings. Study participation will last for 90 days."
16410248|NCT05079204|Other|Intra oral scan|Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions Intervention consists in an 3D intra oral representation of the oral cavity.
16410249|NCT05079204|Other|No intervention|No intervention
16410251|NCT05078034|Device|Helmet Non-Invasive Ventilation (HNIV)|HNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated.
16410252|NCT05078034|Device|High Flow Nasal Oxygen|HFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated.
16410253|NCT05077176|Biological|CoronaVac|One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
16410254|NCT05077176|Biological|Turkovac|One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
16410255|NCT05076214|Behavioral|Aerobic exercise in group|"The goal with every new week should be making every workout a little bit harder than the week before.
~Strength sessions
~Week 1- 6: 12-18 repetitions (reps) x 2 set per exercise and muscle 30 seconds (s) rest between exercise Week 7-12: 10-12 reps x 3 set per exercise and muscle 20 s rest between exercises Adding weight with gym equipment or changing body position in the exercises to succeed with the rep scheme and making it harder as the group develop their physical and mental ability.
~Conditioning sessions
~Week 1- 6: 75 seconds work time x 1 set per exercise 30 seconds of rest between exercises Week 7-12: 50 seconds work time x 2 set per exercise 20 seconds of rest between exercises Mixed sessions
~Week 1- 6: 35 s work time per exercise 25 s rest between exercises x 2 rounds Week 7-12: 45 s work time per exercise 15 s rest between exercises x 2 rounds"
16410256|NCT05076214|Behavioral|Leisure activities in group|The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or cards together
16410257|NCT05074758|Diagnostic Test|alveolar dead-space quantification|measurement of alveolar dead-space based on volumetric capnography
16410258|NCT05074758|Diagnostic Test|Coagulation activation and impaired fibrinolysis explorations|"blood sampling:
~Fibrinolytic components
~NETs components
~Elastase-derived fragments of proteins of interest"
16410259|NCT05074758|Diagnostic Test|Endothelial activation / endothelial senescence|circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )
16410260|NCT05074264|Procedure|Biopsy|Undergo biopsy
16410261|NCT05074264|Procedure|Biospecimen Collection - Anal|Undergo collection of anal swabs
16410262|NCT05074264|Procedure|Biospecimen Collection - Cervical|Undergo collection of cervical swabs
16410263|NCT05074264|Procedure|Colposcopy|Undergo colposcopy
16410264|NCT05074264|Procedure|High Resolution Anoscopy|Undergo high-resolution anoscopy
16410265|NCT05074264|Procedure|Imaging Technique|Undergo cervical imaging
16410266|NCT05073315|Drug|Adalimumab|Participants will receive subcutaneous (SC) injection of adalimumab
16410267|NCT05073315|Drug|ABP 501|Participants will receive SC injection of ABP 501
16410268|NCT05072743|Device|Photobiomodulation Therapy|PBMT will be applied to the cervical spine using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries.
16410269|NCT05072041|Device|Nexsphere™|Nexsphere™ is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for spherical gel foam are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
16410270|NCT05071313|Biological|Ad26.RSV.preF-based vaccine|Ad26.RSV.preF-based vaccine will be administered as single IM injection.
16410271|NCT05071313|Biological|Quadrivalent High-dose Influenza Vaccine|Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
16410272|NCT05071313|Biological|Placebo|Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
16410273|NCT05070546|Biological|Ad26.RSV.preF-based Vaccine|Participants will receive a single IM injection of an RSV vaccine.
16410274|NCT05070546|Other|Placebo|Participants will receive a single IM injection of matching placebo.
16410275|NCT05070117|Behavioral|Exercise training|Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.
16410276|NCT05069623|Biological|VB10.2129|0.3 mg, 1 mg or 3 mg on Day 0 and Day 21 or 3 mg on Day 0
16410277|NCT05069623|Biological|VB10.2210|3 doses (dose to be determined) on Day 0 and Day 21 or highest dose (TBD) on Day 0
16410278|NCT05069116|Other|Training in surgery|The study evaluates the training process of general surgery residents - in classic surgery, as well as laparoscopic surgery, from hospital activity to extracurricular activities.
16410279|NCT05065450|Device|Intracranial Stimulation|Electrodes localized to the BLA will be stimulated with either active-BLAES (0.5-3.5 mA, theta-modulated gamma burst) electrical stimulation for a 1-sec duration immediately following item image presentation or sham-BLAES (zero-amplitude). At later stages of the project, stimulation parameters and timing will be varied and triggered not at random, but by real-time closed-loop analysis of memory biomarkers in the medial temporal lobe.
16410280|NCT05065268|Device|Immersive Virtual-Reality Stimulation|IVR stimulation every 2 days (± 1 day) at any time during the day (delivery).
16410281|NCT05064657|Procedure|Bubble blowing method|"The investigators were used Bubble blowing method and ball squeezing method.
~To child were used a ball squeezing method during the blood collection process."
16410282|NCT05062473|Behavioral|Lifestyle Modification Webinars Focused on Hypertension Control|Participation in a 12-week health education telemedicine curriculum
16410284|NCT05062460|Other|2 hour blood glucose monitoring|Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring
16410286|NCT05061134|Drug|Ceralasertib|Ceralasertib (240 mg) will be administered orally twice daily.
16410287|NCT05061134|Biological|Durvalumab|Durvalumab (1500 mg) will be administered intravenously once every 28 days for participants who weight above > 30 kgs. For participants who weigh below ≤ 30 kgs, weight-based dosing equivalent to 20 mg/kg of durvalumab will be administered.
16410288|NCT05060484|Biological|SCT1000|HPV vaccine
16410289|NCT05060484|Biological|Gardasil®9|HPV vaccine
16410290|NCT05060484|Biological|Gardasil®|HPV vaccine
16410291|NCT05060484|Other|placebo|adjuvent
16410292|NCT05059834|Behavioral|online mindfulness resources|a free mindfulness resource online for patients with general anxiety disorder
16410293|NCT05059834|Behavioral|usual care|patient will continue to receive drug and advice from doctors and nurses for their anxiety disorder
16410294|NCT05057572|Drug|Carvedilol|- Arm A will receive carvedilol plus standard medical therpy,Carvedilol: will be started with initial dose of 3.125 mg BD then After 3 days, increase the dose to 6.25 mg BD, Maximum dose would be 12.5 mg BD, the same shall be switch to Maximum tollrated dose if SBP>90, HR >55.
16410295|NCT05057572|Drug|Standard Medical Treatment|"Arm B will receive standard medical therapy.SMT (as described) that is Grade II ascites - Lasilactone (20/50) OD then Change after 1 week as per response, monitor diuretic intolerance.
~Grade III ascites will undergo large volume paracentesis, lasilactone (20/50) OD Both groups will receive albumin as indicated (LT references as per protocol will be send for eligible patients)"
16410296|NCT05057546|Drug|GnRH antagonist|GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
16410297|NCT05055713|Procedure|Endoscopic therapy+ beta blockers|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
16410298|NCT05055713|Procedure|Endoscopic therapy+ PSE+beta blockers|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16410299|NCT05055713|Procedure|Beta blockers+Endoscopic therapy|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
16410300|NCT05055713|Procedure|Beta blockers+Endoscopic therapy+ PSE|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16410301|NCT05055713|Procedure|Endoscopic therapy+Somatostatin|The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
16410302|NCT05055713|Procedure|Endoscopic therapy+PSE+Somatostatin|The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16410303|NCT05055401|Procedure|Direct Laryngoscopy|The participant will perform a direct laryngoscopy on a Laerdal SimMan 3G under healthy conditions and under limited cervical range of motion.
16410304|NCT05055401|Procedure|Laryngeal Mask Airways|The participant will perform LMA placement on a Laerdal SimMan 3G under healthy conditions and under full tongue edema.
16410305|NCT05055401|Procedure|Video Laryngoscopy|The participant will perform video laryngoscopy on a Laerdal SimMan 3G under healthy conditions and under half tongue edema with pharyngeal obstruction.
16410306|NCT05053087|Drug|Ropivacaine Continuous Infusion|0.2% continuous infusion 6mL/hr
16410307|NCT05053087|Drug|Ropivacaine Intermittent Bolus|0.2% intermittent bolus infusion 8mL every 2 hours
16410308|NCT05053087|Drug|Placebo|Saline filled catheter
16410309|NCT05051527|Drug|Legalon® 140 mg|Legalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision
16410310|NCT05050942|Drug|CAM2029|CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
16410311|NCT05050942|Drug|Octreotide LAR|Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
16410312|NCT05050942|Drug|Lanreotide ATG|Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
16410315|NCT05049798|Drug|Guselkumab|Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with guselkumab, will be observed according to standard clinical practice.
16410316|NCT05049798|Drug|IL-17i|Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with IL-17i, will be observed according to standard clinical practice.
16410317|NCT05048979|Other|Exercise|Telehealth-facilitated supervised exercise program. Veterans with PAD will be enrolled in a 12-week, 3 day a week, aerobic training program in a self-selected location.
16410318|NCT05047705|Behavioral|Distress Tolerance Skills Training|Individuals with TS will receive distress tolerance skill training. Therapeutic skill training will consist of 4 weekly 1-hour sessions. Skill training will occur either in-person or remotely via videoconferencing software. Sessions will focus on building participants' distress tolerance skills with strategies drawn from third-wave CBT.
16410319|NCT05044793|Device|OMNI® Surgical System|The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
16410320|NCT05044507|Device|BQ 2.0|frequency and intensity parameters will be set to zero so that no stimulation is delivered
16410321|NCT05044507|Device|BQ 2.0|The BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery
16410322|NCT05041803|Drug|CTP-543|Twice daily dosing
16410323|NCT05038800|Biological|MK-0482|IV infusion
16410334|NCT05033912|Drug|CST-2032, matching placebo for CST-2032, CST-107|CST-2032 and matching placebo oral liquid; CST-107 white capsules
16410335|NCT05032690|Drug|Bosutinib capsule|Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast
16410336|NCT05032690|Drug|Bosutinib capsule|Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
16410337|NCT05032690|Drug|Bosutinib capsule|Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
16410338|NCT05032690|Drug|Bosutinib|Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours
16410339|NCT05029921|Drug|Ustekinumab|Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.
16410340|NCT05028816|Device|Side 1: Final layer closure with force modulating tissue bridges (FMTB)|Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
16410341|NCT05028816|Other|Side 1: Final layer dermal closure with poliglecaprone 25 suture|Current method of wound closure
16410342|NCT05028816|Device|Side 2: Final layer closure with force modulating tissue bridges (FMTB)|Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
16410343|NCT05028816|Other|Side 2: Final layer dermal closure with poliglecaprone 25 suture|Current method of wound closure
16410357|NCT05027919|Drug|Morphine|30mg subcutaneous injections of morphine 4 times daily on days 1 through 5.
16410358|NCT05027919|Drug|Naloxone + lofexidine pretreatment|0.4mg naloxone injection during the Naloxone challenge + pretreatment with oral lofexidine (25% of max daily dose scheduled during lofexidine taper)
16410359|NCT05027919|Drug|Naloxone + placebo pretreatment|0.4mg naloxone injection during the Naloxone challenge
16410360|NCT05027919|Drug|Lofexidine|Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.
16410361|NCT05027074|Drug|MK-2060|MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
16410362|NCT05027074|Drug|Placebo|Normal saline administered via IV infusion
16410363|NCT05026801|Drug|Azithromycin plus hydroxychloroquine|All patients will receive active comparator. One group will receive placebo on D1-3 followed by active comparator D4-9, while the other group will receive active comparator D1-6 followed by placebo D7-9.
16410364|NCT05025423|Drug|Venetoclax Oral Tablet [Venclexta]|Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
16410370|NCT05025085|Drug|AGEN1777|An immunoglobulin gamma (IgG1) antibody
16410371|NCT05025085|Drug|a PD-1 inhibitor|Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
16410372|NCT05023174|Procedure|Hiatal Hernia Repair with Platelet Rich Plasma|Platelet rich plasma will be injected into the crura of the diaphragm and coating the mesh placed during surgery.
16410373|NCT05023174|Procedure|Hiatal Hernia Repair without Platelet Rich Plasma|Surgery will be performed without the addition of platelet rich plasma injection
16410374|NCT05021185|Other|Interactive Mobile Doctor (iMD)|Video educational tool
16410375|NCT05020795|Procedure|Endovascular thrombectomy|Clot retrieval for large vessel occlusion in acute ischaemic stroke
16410376|NCT05019885|Drug|Ketamine Hydrochloride|Three times a week (M, W, F) for 2 consecutive weeks.
16410377|NCT05019872|Behavioral|(Components of) pasta meal|Samples will be provided one by one in cups labeled with an unique code.
16410378|NCT05019729|Drug|VRC-MALMAB0114-00-AB|VRC-MALMAB0114-00-AB is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozite protein.
16410379|NCT05019729|Other|CHMI|Negative control designed to test the infection ability of the CHMI.
16410380|NCT05017922|Procedure|transarterial chemoembolization combined with endoscopic therapy|TACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary.
16410383|NCT05017012|Biological|MK-3475A|MK-3475A is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and MK-5180 for SC administration. Participants will receive MK-3475A SC at Day 1 of Cycles 1 and 3.
16410384|NCT05017012|Biological|Pembrolizumab|Participants will receive pembrolizumab 400 mg IV on Day 1 of Cycles 2 and 4 to 18.
16410385|NCT05017012|Drug|Pemetrexed|Participants may receive 500 mg/m^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
16410386|NCT05017012|Drug|Carboplatin|Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
16410387|NCT05017012|Drug|Paclitaxel|Participants may receive 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
16410388|NCT05017012|Drug|Nab-paclitaxel|Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
16410389|NCT05017012|Drug|Axitinib|Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.
16410390|NCT05017012|Drug|Cisplatin|Participants may receive 75 mg/m^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
16410391|NCT05012267|Other|16-hour PP|PP according to previous study
16410392|NCT05012202|Device|Hemi device|A sample of vaginal blood will be collected following delivery and analyzed by the device to provide a hematocrit level, which will be masked to the clinical team.
16410394|NCT05011357|Drug|Phenylephrine|Phenylephrine will be administered as an infusion
16410395|NCT05011357|Drug|Saline Control|Saline infusion
16410433|NCT04984616|Drug|40 mg Atorvastatin/day for 120 days P.O.|Oral administration of Atorvastatin 40 mg/daily for 120 days
16410400|NCT05007756|Radiation|UVB Challenge|UVB challenge will be administered dermally through Lumera Phototherapy System.
16410401|NCT05007106|Biological|Pembrolizumab/Vibostolimab Co-Formulation|Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
16410402|NCT05007106|Biological|Pembrolizumab|Pembrolizumab 200 mg administered via IV infusion Q3W.
16410403|NCT05007106|Drug|Lenvatinib|Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
16410404|NCT05007106|Drug|5-Fluorouracil|5-FU 800 mg/m^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
16410405|NCT05007106|Drug|Cisplatin|Cisplatin 80 mg/m^2 administered via IV infusion Q3W up to 6 cycles
16410406|NCT05007106|Drug|Paclitaxel|Paclitaxel 90 mg/m^2 administered via IV infusion on days 1, 8, and 15 of every 28-day treatment cycle
16410407|NCT05005442|Biological|Pembrolizumab/vibostolimab coformuation|Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
16410411|NCT05003115|Behavioral|Motivational interviewing|In this trial, motivational interviewing (MI) is the intervention. The MI sessions will embody the spirit of MI (PACE - Partnership, Acceptance, Compassion and Evocation) and the use of MI strategies (OARS - Open-ended questions, Affirmations, Reflections and Summaries) and MI communication processes (engagement, focusing, evoking and planning).
16410412|NCT05000840|Behavioral|Enrollment in existing SDRI diabetes education programs|Education will be based on a modification of the existing Ocho Pasos education program provided by SDRI.
16410413|NCT05000515|Other|High-resistance inspiratory muscle strength training|Participants will perform inspiratory muscle strength training.
16410414|NCT05000515|Other|Aerobic exercise|Participants will perform brisk walking.
16410415|NCT04999631|Drug|Squaric Acid Dibutyl Ester|Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
16410416|NCT04999631|Drug|Ethanol Solution|Control
16410417|NCT04999111|Biological|Ad26.COV2.S|Participants will receive IM injection of Ad26.COV2.S.
16410418|NCT04998851|Drug|Ocrelizumab|Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.
16410419|NCT04997369|Device|Rezum|The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).
16410420|NCT04996719|Drug|Rapamune|We will start the dose at 0.5mg capsule every other day for 2 weeks. If participants tolerate this dose and trough blood levels are (≤4ng/mL), the dose of rapamycin will be increased to 0.5mg daily for the duration of the study. If necessary, dose can remain at 0.5 mg every other day, depending on the trough level. To avoid immunosuppression, we will target lower dose of rapamycin, maintain lower trough serum levels (≤4ng/mL).
16410421|NCT04994483|Drug|Simufilam|Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.
16410422|NCT04994483|Drug|Placebo|Matching placebo given b.i.d. for 52 weeks.
16410423|NCT04990440|Drug|Bermekimab|Participants will receive bermekimab IV.
16410424|NCT04990440|Drug|Placebo|Participants will receive placebo IV.
16410425|NCT04988308|Drug|Bermekimab|Bermekimab will be administered subcutaneously.
16410426|NCT04988308|Drug|Adalimumab|Adalimumab will be administered subcutaneously.
16410427|NCT04988308|Drug|Placebo|Placebo will be administered subcutaneously.
16410428|NCT04987138|Device|Zenflow Spring System|The Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary.
16410429|NCT04987138|Device|Sham Procedure|A18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure.
16410430|NCT04985955|Drug|Tofacitinib|Tofacitinib tablet will be administered orally.
16410431|NCT04985812|Drug|JNJ-67484703|Participants will receive JNJ-67484703.
16410432|NCT04985812|Drug|Placebo|Participants will receive placebo to JNJ-67484703.
16410434|NCT04984616|Drug|Atorvastatin 80|Oral administration of Atorvastatin 80 mg/daily for 120 days
16410436|NCT04984343|Radiation|Radiation Therapy|"Eligible subjects will be randomly assigned to 5 or 2 fraction treatment groups in a 1:1 ratio using a computer-generated randomization scheme.
~After consent and eligibility verification, patients will undergo CT/MRI simulation and radiotherapy planning. Patients will receive treatment to the prostate +/- seminal vesicles per treating physician's discretion in either 37.5 Gy in 5 fractions or 25 Gy in 2 fractions. SIB use is at treating physician's discretion and should be concordant with imaging and biopsy findings with no PTV expansion.
~Subjects on 5 fraction arm should be treated on non-consecutive days. Subjects on the 2 fraction arm must have >72 hours between beginning of each fraction."
16410437|NCT04984317|Drug|onabotulinumtoxin A|One-time injection of 100U BOTOX
16410438|NCT04981574|Other|Massage and stretching on neck area and thoracic thrust manipulation|"Twenty (20) minutes massage in the neck area. The volunteer will be in prone position during the massage.
~Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a V). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
~Ten (10) minutes specific stretching for the neck area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching will be made on the trapezius superior, musculus levator scapulae and sternocleidomastoideus holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times."
16410439|NCT04981574|Other|Massage and stretching on low back area and thoracic thrust manipulation|"Twenty (20) minutes massage in the low back area. The volunteer will be in prone position during the massage.
~Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a V). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
~Ten (10) minutes specific stretching for the low back area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching activities will be: cat-cow pose, lower back stretches and knee twist holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times."
16410440|NCT04978454|Biological|Influenza RG-A/Texas/71/2017 (H3N2) Challenge|RG-A/Texas/71/2017 (H3N2) is an infectious influenza virus and requires handling at BioSafety Level 2. The challenge virus will be administered intranasally in a volume of approximately 500 ?L per nostril. Intranasal challenge will be carried out using the Intranasal Mucosal Atomization ( MAD Nasa(TM)) Device attached to a 1 mL syringe.
16410441|NCT04978454|Other|Placebo|Sucrose phosphate glutamate (SPG) inoculum
16410442|NCT04976621|Behavioral|Behavioral Activation|BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. BA protocol components include: goal setting (especially for activities that promote social connectedness), creation of a plan (broken down into steps), strategies for implementation of steps, identification of potential barriers, tactics to overcome them, activity monitoring and scheduling, and emotion regulation strategies. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in an office at the VA rehabilitation clinic or the home, depending on the veteran's preference.
16410443|NCT04976621|Other|Treatment as Usual|Treatment as Usual refers to usual care provided by the VA medical center.
16410444|NCT04975399|Drug|CC-92328|CC-92328
16410445|NCT04969861|Drug|Bempegaldesleukin|Specified dose on specified days
16410446|NCT04969861|Drug|Pembrolizumab|Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
16410447|NCT04965844|Device|Oxygen close-loop|The Automatic FiO2 option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the Oxygen setting to keep the patient's SpO2 in the target range.
16410448|NCT04965844|Device|No intervention|Manual FiO2 adjustment according to SpO2 values
16410449|NCT04965727|Procedure|Device implantation|The intervention involves the insertion of lead electrodes (Medtronic SenSight Directional Lead) in the right and left lateral hypothalamus through craniotomy and an implantable pulse generator (Medtronic Model B35200 Percept™ PC) in the upper part of the pectoralis major (under the clavicle).
16410450|NCT04964765|Diagnostic Test|Mapping|CardioInsightTM Cardiac Mapping System is a non-invasive single beat cardiac mapping system that provides three-dimensional electroanatomic maps of the heart. The CIT vest is attached to the patient's torso for non-invasive mapping. To ensure correct and rapid mapping of the NOAF by the CIT device, it is essential to briefly slow down the patient's heart rate below 50bpm for a few seconds. Therefore 6mg adenosine as a rapid i.v. bolus will be administered. The adenosine application will slow down the patient's heart rate and allow for correct mapping by the CIT device. Medical therapy of atrial fibrillation is started immediately according to local protocol. Since non-invasive mapping is performed within a few minutes, the therapy of atrial fibrillation will not be critically delayed. Consecutively, a low-dose thoracic computed tomography (CT) scan (neck to upper abdomen) will be performed independent from the patient's rhythm.
16410451|NCT04964765|Diagnostic Test|Computed tomography scan|The CT scans will follow a standardised protocol as predefined by the manufacturer of the CIT vest, Medtronic (Dublin, Ireland). After the sensor array has been placed on the patient, the patient is ready to undergo a CT scan to register each electrode's locations with respect to the body surface. All CT scans cover a body region from neck to the upper abdomen, have no cardiac gating performed or any contrast agent given. The CT scans are acquired on 3 CT scanners manufactured by Siemens Corporation (Berlin, Germany) with a fixed tube voltage of 80 kVp and 250 effective mAs (=mAs/pitch). The reconstruction parameters are of 3 mm slice thickness and of 1.5 mm increment (slice overlap) The estimated effective dose (ED) is 3.2 mSv per patient.
16410452|NCT04964544|Combination Product|5 mg rosuvastatin calcium with a Web App (combination product)|The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.
16410453|NCT04963725|Drug|Ustekinumab|No intervention or treatment will be administered as part of this study. Data available per routine clinical practice at clinic visits as well as directly from participant using a smartphone/tablet application will be collected.
16410454|NCT04960202|Drug|PF-07321332|PF-07321332 (tablet)
16410455|NCT04960202|Drug|Ritonavir|Ritonavir (capsule)
16410457|NCT04957095|Drug|Inbrija|Inbrija will be administered to Parkinson's disease patients only. Patients will receive 2 capsules (84 mg) of medication.
16410458|NCT04957095|Other|Subcortical Stimulation|Subcortical simulation of the deep brain stimulation surgery target site will be applied by clinically placed deep brain stimulation electrodes at the previously determined therapeutic setting
16410459|NCT04956692|Biological|Pembrolizumab SC|SC injection
16410460|NCT04956692|Biological|Pembrolizumab IV|IV injection
16410461|NCT04956692|Drug|Paclitaxel|IV injection
16410462|NCT04956692|Drug|Nab-Paclitaxel|IV infusion
16410463|NCT04956692|Drug|Carboplatin|IV infusion
16410464|NCT04956692|Drug|Cisplatin|IV infusion
16410465|NCT04956692|Drug|Pemetrexed|IV infusion
16410466|NCT04956224|Biological|VLA2001|"whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide (Wuhan based)
~2 vaccinations 28 days apart"
16410467|NCT04956224|Biological|VLA2101|"whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide (variant based)
~2 vaccinations 28 days apart"
16410468|NCT04955626|Biological|BNT162b2|Intramuscular Injection
16410469|NCT04955626|Other|Placebo|Intramuscular Injection
16410470|NCT04954859|Drug|GSK3228836|No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.
16410471|NCT04950959|Device|Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T|The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.
16410472|NCT04950712|Procedure|Blood sampling|Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).
16410473|NCT04950712|Procedure|Anogenital lesion swab collection|Anogenital lesion swab of all lesions are collected at screening visit (only for newly infected HSV-2 patients) and at first genital HSV-2 recurrence during the study period.
16410474|NCT04950660|Drug|Caffeine Tablet|Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
16410475|NCT04950660|Drug|Placebo|Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
16410478|NCT04948645|Drug|ABBV-CLS-7262|Oral
16410479|NCT04948645|Drug|Placebo|Oral
16410480|NCT04945720|Procedure|Hepatic artery infusion chemotherapy（HAIC）|hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment
16410481|NCT04945720|Drug|Durvalumab|Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).
16410482|NCT04944992|Drug|Efinopegdutide 20 mg/mL|Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
16410483|NCT04944992|Drug|Semaglutide 1.34 mg/mL|Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
16410484|NCT04944862|Biological|CDX-0159|administered intravenously
16410485|NCT04944862|Drug|Normal saline|administered intravenously
16410486|NCT04941300|Other|Mailed FIT Outreach|We will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return.
16410487|NCT04941300|Other|Standardized navigation|"The standardized navigation includes, but is not limited to, the following key components:
~Identification of individuals with abnormal FIT
~Results review and colonoscopy order by provider
~Results reporting to patient
~Insurance approval for colonoscopy
~Colonoscopy scheduling
~Bowel preparation & colonoscopy completion
~Colonoscopy results provided to patient and CHC
~Referral-to-Care for patients with CRC (if necessary)"
16410488|NCT04940897|Other|Use of CareSens ketone meter|Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA
16410489|NCT04939545|Drug|Ropivacain|"Intercostal continuous loco-regional ropivacaine (2 mg/ml) administration over an elastomeric pump through a surgically placed intercostal catheter (ICC) for a maximum of 72h.
~As concomitant treatments a standardized anesthesia protocol including intravenous continuous application of propofol and remifentanil is used. Additionally, i.v. metamizol at a dose of 1 g will be administered at the end of surgery as a standard, if not contraindicated.
~In a standardized postoperative pain protocol the use of basic oral medication is documented as part of the postoperative follow-up and consists of:
~ibuprofen 3 x 400 mg p. o. for 3 days, metamizol 4 x 1 g p. o. for 3 days; if ibuprofen and/or metamizol contraindicated then paracetamol p. o. 3 x 1g for 3 days will be administered; morphine 10 mg p. o. 6 times daily will be given on a patient demand basis."
16410536|NCT04919031|Device|Inspiratory muscle trainer|POWER breathe IMT is a drug-free, hand-held breathing training device. The medical term for this type of breathing training is Inspiratory Muscle Training, or IMT. POWER breathe IMT exercises the main muscles you use to breathe in, primarily your diaphragm and intercostal
16410537|NCT04917861|Biological|mRNA-1893|Solution for injection
16410538|NCT04917861|Biological|Placebo|0.9% sodium chloride solution for injection
16410647|NCT04802811|Drug|SHR2150；Placebo|Single dose；SHR2150-dose 3 or Placebo-dose 3
16410490|NCT04939545|Drug|NaCl 0.9%|"Intercostal continuous loco-regional placebo solution (NaCl 0,9%) administration over an elastomeric pump through a surgically placed intercostal catheter (ICC) for a maximum of 72h. As concomitant treatments a standardized anesthesia protocol including intravenous continuous application of propofol and remifentanil is used. Additionally, i.v. metamizol at a dose of 1 g will be administered at the end of surgery as a standard, if not contraindicated.
~In a standardized postoperative pain protocol the use of basic oral medication is documented as part of the postoperative follow-up and consists of:
~ibuprofen 3 x 400 mg p. o. for 3 days, metamizol 4 x 1 g p. o. for 3 days; if ibuprofen and/or metamizol contraindicated then paracetamol p. o. 3 x 1g for 3 days will be administered; morphine 10 mg p. o. 6 times daily will be given on a patient demand basis."
16410491|NCT04938817|Biological|coformulation pembrolizumab/quavonlimab|Intravenous (IV) infusion
16410492|NCT04938817|Drug|lenvatinib|Oral administration
16410493|NCT04938817|Biological|MK-4830|IV infusion
16410494|NCT04938817|Biological|coformulation favezelimab/pembrolizumab|IV infusion
16410495|NCT04938791|Other|Isometric activity|Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.
16410496|NCT04937920|Biological|DBI-002 probiotic gel|Topical application on skin affected with tinea versicolor
16410497|NCT04937920|Biological|Aqueous gel|Topical application on skin affected with tinea versicolor
16410498|NCT04936490|Drug|Crocin|15 mg/d
16410499|NCT04936490|Drug|Placebo|15 mg/d
16410500|NCT04936113|Biological|FB-401|Topical
16410501|NCT04935710|Behavioral|Cope2Thrive|Cognitive Behavioral Therapy-based program to help teens deal with anxiety, stress and depression by showing them how to develop skills needed to stop negative thoughts and start thinking and behaving in more positive ways.
16410502|NCT04935710|Genetic|Usual care|Children at risk who are not randomized to Cope2Thrive at any point of time serve as the control group.
16410503|NCT04935177|Drug|Imlifidase|Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
16410504|NCT04935177|Procedure|PLEX|PLEX is performed according to the respective site's standard procedure for desensitization.
16410505|NCT04935177|Drug|IVIg|IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization.
16410506|NCT04935177|Drug|Anti-CD20 antibodies|Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
16410507|NCT04935177|Drug|Eculizumab|Eculizumab according to the respective site's standard procedure for desensitization.
16410508|NCT04935177|Other|Remain on wait list|Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
16410509|NCT04933747|Drug|Iberdomide|Administration of a single oral dose of 1mg iberdomide in participants
16410510|NCT04933747|Drug|Iberdomide|Administration of a single oral dose of 1mg iberdomide in participants on 2 occasions - once on a dialysis day and once on a non-dialysis day
16410521|NCT04927416|Drug|68-Gallium-DOTATATE-PET/CT|68Ga-DOTATATE is administered one-time via intravenous injection of 5 mCi in a volume of 3-5 ml containing up to 50 mcg [68Ga] DOTATATE.
16410522|NCT04925154|Behavioral|The only intervention will be the information brochure that will be given after the first questionnaire.|The information brochure will be given to both groups at the same time at 2-3 weeks after the first consultation (patients group) or after answering the first questionnaire (physicians group).
16410523|NCT04925024|Biological|Lomecel-B medicinal signaling cells|A single administration of Lomecel-B will be performed via 6-10 intramyocardial injections into the right ventricle during the participant's standard of care stage II palliation operation. Dosing is based on body weight. Each patient will be given 2.5 x 10^5 cells per kg of body weight. The entire dose of the cells will be roughly 600 microliters.
16410524|NCT04924101|Biological|Pembrolizumab|IV infusion
16410525|NCT04924101|Biological|MK-4830|IV infusion
16410526|NCT04924101|Biological|MK-5890|IV infusion
16410527|NCT04924101|Drug|Lenvatinib|Oral capsule
16410528|NCT04924101|Drug|Etoposide|IV infusion
16410529|NCT04924101|Drug|Cisplatin|IV infusion
16410530|NCT04924101|Drug|Carboplatin|IV infusion
16410531|NCT04924075|Drug|Belzutifan|Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
16410532|NCT04922021|Drug|LEO 138559|LEO 138559 is an antibody given by injection just under the skin.
16410533|NCT04922021|Drug|LEO 138559 placebo|LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559.
16410534|NCT04919369|Biological|Atezolizumab|Given IV
16410535|NCT04919369|Drug|Tretinoin|Given PO
16410645|NCT04802811|Drug|SHR2150；Placebo|Single dose；SHR2150-dose 1 or Placebo-dose 1
16410541|NCT04914429|Drug|Guselkumab|Guselkumab 100 mg will be administered as a SC injection.
16410542|NCT04914429|Drug|Placebo|Matching placebo will be administered as a SC injection.
16410543|NCT04912791|Procedure|Obstetric anesthesia and analgesia|All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor
16410544|NCT04908904|Dietary Supplement|Cafestol|Capsule with 12 mg cafestol
16410545|NCT04908904|Dietary Supplement|Placebo|Placebo capsule without cafestol
16410546|NCT04908475|Drug|Risankizumab|Subcutaneous injection
16410547|NCT04908475|Drug|Apremilast|Oral Tablets
16410548|NCT04908293|Other|Biorepair toothpaste|Use of New Biorepair Advanced Sensitive for home oral care.
16410549|NCT04908293|Other|Colgate toothpaste|Use of Colgate toothpaste for home oral care.
16410550|NCT04905173|Other|Squat-to-stand maneuver|Subjects will squat for 5 seconds and then stand. The squat-to-stand exercise will be done up to 10 times, and then immediately undergo echocardiographic imaging.
16410551|NCT04905173|Drug|Amyl nitrite inhalation|Subjects will inhale amyl nitrite prior to undergoing echocardiographic imaging. This is administered according to current laboratory protocol and is part of standard of care. This is an FDA-regulated drug that will be used as a control and will not be studied experimentally.
16410552|NCT04905173|Other|Valsalva|Subjects will undergo echocardiographic imaging while performing the Valsalva maneuver. This is according to current laboratory protocol and is part of standard of care.
16410553|NCT04903223|Drug|Rosuvastatin 10mg|Rosuvastatin will be administered to all participants on Study Day #2
16410556|NCT04901689|Drug|Leronlimab|Leronlimab 700 mg
16410557|NCT04901689|Drug|Placebo|Placebo
16410559|NCT04895982|Biological|BNT162b2|Intramuscular Injection
16410560|NCT04895358|Biological|pembrolizumab|Intravenous (IV) infusion
16410561|NCT04895358|Drug|paclitaxel|IV infusion
16410562|NCT04895358|Drug|nab-paclitaxel|IV infusion
16410563|NCT04895358|Drug|liposomal doxorubicin|IV infusion
16410564|NCT04895358|Drug|capecitabine|oral administration
16410565|NCT04895358|Drug|normal saline|IV infusion
16410566|NCT04895358|Drug|dextrose|IV infusion
16410567|NCT04891978|Behavioral|AIRQ|A validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.
16410568|NCT04891978|Behavioral|Asthma Checklist|A validated, 3-page tool, based on GINA and NAEPP guidelines to assist providers with recognition, evaluation, and optimization of all patients with asthma. In this study, healthcare providers will be required to complete the assess component (page 1) of the Asthma Checklist .
16410569|NCT04891978|Behavioral|PRECISION Program (Educational Resources)|Educational resources accessible to all providers in the study. There are provider-facing and patient-facing educational materials that can be accessed during the patient visit or as resources for before/after visits. Resources can be downloaded and sent to patients per the discretion of providers.
16410573|NCT04888039|Other|quality of life questionnaires (EORTC QLQ-C30 ; EORTC QLQMY20 ; EQ-5D-5L ; Cohen's stress scale)|"Excepted the delivery of quality of life questionnaires (a maximum of 5 times during the course of treatment) specific to this study, only the data available during the course of patient care will be collected.
~The quality of life questionnaires and the perceived stress questionnaire will be given to patients :
~At diagnosis (before starting 1st line of treatment),
~after the induction phase (before autologous transplantation for patients who will be transplanted),
~after the consolidation phase,
~after the maintenance phase : 1 year and 2 years after the start of the maintenance."
16410574|NCT04887506|Drug|TAVT-45|250 mg abiraterone acetate granules for oral suspension in a sachet, administered twice daily.
16410575|NCT04887506|Drug|Zytiga|500 mg tablet, administered twice daily.
16410576|NCT04887506|Drug|Prednisone|mCSPC patients will receive 5 mg orally once daily. mCRPC patients will receive 5 mg orally twice daily.
16410577|NCT04886154|Combination Product|MenABCWY-2Gen low dose vaccine|MenABCWY-2Gen low dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose_06 Group and ABCWY low dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose_01 Group in study Phase II (Sourcing).
16410578|NCT04886154|Combination Product|MenABCWY-2Gen high dose vaccine|MenABCWY-2Gen high dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose_06 Group and ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose_01 Group in study Phase II (Sourcing).
16410579|NCT04886154|Combination Product|Placebo|Placebo is administered intramuscularly in the deltoid region of the non-dominant arm as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose_06 Group, ABCWY low dose_02 Group, ABCWY high dose_06 Group, ABCWY high dose_02 Group and Control Group in study Phase II (Formulation and Schedule-finding).
16410580|NCT04886154|Combination Product|MenB vaccine|MenB vaccine is administered intramuscularly in the deltoid region of the non-dominant arm, whenever it's possible, as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
16410581|NCT04886154|Biological|MenACWY vaccine|MenACWY vaccine is administered intramuscularly in the deltoid region of the dominant arm as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
16410582|NCT04883619|Other|Placebo|Placebo will be administered intravenously.
16410583|NCT04883619|Drug|Nipocalimab|Nipocalimab dose 1 and dose 2 will be administered intravenously.
16410584|NCT04883619|Drug|Standard-of-care treatment|Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
16410585|NCT04882449|Device|Bodyport Scale|The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.
16410586|NCT04882098|Drug|Guselkumab|Participants will receive guselkumab as SC injection.
16410587|NCT04882098|Drug|Placebo|Participants will receive matching placebo as SC injection.
16410588|NCT04881123|Drug|SER150|Dosage Level(s): 30 mg (1 capsule of 15 mg twice a day - morning and evening)
16410589|NCT04881123|Drug|Placebo|Dosage Level(s): Matched placebo (1 capsule twice a day - morning and evening)
16410590|NCT04877015|Device|Active Vibrotactile Coordinated Reset (vCR)|Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.
16410591|NCT04877015|Device|Sham Vibrotactile Coordinated Reset (vCR)|Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.
16410592|NCT04874532|Other|Community Paramedic Program|Patients will be seen for a 1-hr in person evaluation and follow-up will be determined on an individual basis based on patient need. During each visit, CPs will perform health status and social determinants of health assessments, physical exam, medication review/counseling, and goal setting/review.
16410593|NCT04874532|Other|Education Material|Participants will be provided with a diabetes resource card, which will provide a list of clinic and community-based diabetes resources, along with a diabetes education packet, which will include information on diabetes self-management, healthy diet, physical activity, glucose self-monitoring, and hypoglycemia.
16410594|NCT04869644|Behavioral|Goal setting|Goal setting: set or agree on a goal defined in terms of behavior to be achieved.
16410595|NCT04869644|Behavioral|Action Planning|Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity.
16410596|NCT04869644|Behavioral|Self-monitoring of behavior|Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.
16410597|NCT04869644|Behavioral|Behavioral Practice/Rehearsal|Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.
16410598|NCT04869644|Behavioral|Habit Formation|Prompt rehearsal & repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.
16410599|NCT04869527|Device|BIOTRONIK ICDs with DX Technology|The BIOTRONIK DX system offers a single chamber ICD that enables sensing of atrial signals through floating atrial dipoles, using a single ventricular lead. This technology enables enhanced arrhythmia diagnosis based on atrial and ventricular electrograms and, in addition, early diagnosis and automatic transmission of AF and heart failure (HF) diagnostic data. The DX technology provides several features in a single chamber device that are usually only found in dual chamber devices, including atrial diagnostics and SVT discrimination - early detection of SAF, increased diagnostics accuracy, dual-chamber discrimination. Nevertheless, the benefits of a single chamber device are preserved: reduced lead complications, reduced procedure complexity, elimination of costs for atrial lead. The DX system also integrates with BIOTRONIK Home Monitoring, allowing physicians to remotely follow their patients' clinical and device statuses with daily updates.
16410602|NCT04865289|Drug|Lenvatinib|Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
16410603|NCT04865289|Biological|Pembrolizumab|Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
16410604|NCT04865289|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
16410605|NCT04865289|Drug|Carboplatin|Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.
16410606|NCT04858854|Other|Sulforaphane, administered as Broccoli sprout extract|Patients will randomized to BSE or Control Group. The group BSE will receive the sulforaphane, administered as broccoli sprout extract for 12 weeks. The dose will increase every four weeks if no side-effects are reported (50 µmmol/day; 100 µmmol/day and 150 µmmol/day, respectivelly). The Control group will receive a placebo (maltodextrin sprayed with copper-chlorophyllin) for the same period (12 weeks). The BSE/placebo will be administered as powder provided in 10 ml of water in the morning in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size.
16410607|NCT04857632|Drug|Statin|atorvastatin 20mg per day for 7 days
16410608|NCT04853004|Diagnostic Test|SARS-CoV2 antibody measurement|Blood samples for serology, collected immediately prior to and five to ten weeks after vaccination against SARS-CoV2, to be analyzed for the presence of SARS-CoV-2 antibodies.
16410609|NCT04850105|Other|Data Collection|"Data on each patient will be collected at study enrollment and at each follow-up visit.
~No mandatory visits, tests, or assessments are required for this study. All visits will be scheduled and conducted according to the clinical site's normal clinical practice."
16410610|NCT04848883|Behavioral|Advanced AMS program|"- Telephone acces to infectious disease experts to discuss patients' therpies during working days.
~- Biweeckly meetings with infectious diseases experts and antimicrobial stewardship group."
16410611|NCT04848883|Behavioral|Standard AMS program|"- Educational materials.
~- Updated local antibiotic guidelines.
~- Promotion of delayed antibiotic prescription.
~- Promotion of Streptococcus pyogenes antigen test (Streptotest) if bacterial tonsillitis is suspected.
~- Daily report to GP of multiresistant bacteria isolates in urinary samples.
~- Quarterly reports to prescribers of AMS outcomes at the centre-level."
16410612|NCT04848454|Drug|Camrelizumab with vinorelbine and cisplatin|Camrelizumab: 200mg iv., every 3 weeks(one cycle), for 1 year(17cycles in total); Vinorelbine: 25mg/m2 day 1, 8 iv. or 60-80 mg/m2 or. day1, 8, every 3 weeks(one cycle), for 6 cycles; Cisplatin: 75mg/m2 (divided into 2 days), every 3 weeks(onr cycle), for 6 cycles.
16410616|NCT04844463|Drug|JNJ-68179280|JNJ-68179280 will be administered as an oral capsule.
16410617|NCT04844463|Other|Placebo|Matching placebo will be administered as an oral capsule.
16410618|NCT04839185|Drug|Ferumoxytol infusion|"Ferumoxytol will be administered intravenously, by infusion, over 30 minutes. It will be used a contrast agent for MRI imaging to detect placental lesions in fetal growth restriction.
~Dose will be 255 mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Ferumoxytol/Feraheme will be administered only once, in one infusion of 255 mg to each subject."
16410619|NCT04839185|Procedure|MRI scan|The MRI scanning procedure will last for approximately 60 minutes.
16410620|NCT04829110|Other|ETOH|Participants will consume Vodka
16410621|NCT04829110|Other|Sucrose|Participants will consume sucrose in solution with water
16410622|NCT04827355|Device|External Upper Esophageal Sphincter (UES) Compression Device|External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
16410623|NCT04827355|Device|Sham Device|External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.
16410624|NCT04826458|Device|TreC-Onco|"At the baseline visit, each patient assigned to arm A will be provided with the electronic diary (installed on a smart phone or tablet), the oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the electronic diary, and the user manual will also be given. This app allows patients to record parameters related to their health state (e.g. medications, blood pressure, weight, fever, side effects or other symptoms) and through the alarm function, it reminds the patient to take the tablets, indicating the exact dosage. In addition, the patient can also indicate the dose reduction or the omission."
16410625|NCT04826458|Other|Paper diary|Patients assigned to arm B will be provided with a paper diary, oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the paper diary.
16410626|NCT04826003|Drug|RO7122290|RO7122290 will be administered using a QW (Part I) or Q3W (Part I or Part II) schedule in combination with 100 mg cibisatamab Q3W with obinutuzumab pre-treatment. The maximum dose of RO7122290 to be explored in combination with cibisatamab with obinutuzumab pre-treatment in this study is 500 mg for the QW dosing interval (Part I) or 1500 mg for the Q3W dosing interval (Part I or Part II).
16410627|NCT04826003|Drug|Cibisatamab|Cibisatamab will be administered to participants at a fixed dose of 100 mg Q3W (100 mg on Day 1 of each 21-day cycle).
16410628|NCT04826003|Drug|Obinutuzumab|Obinutuzumab will be administered as a split dose over two consecutive days (1000 mg on Day -13 and Day -12) or as a single dose given in 1 day (2000 mg on Day -13) at the Investigator's discretion.
16410629|NCT04819542|Device|Bandage|Bandage
16410630|NCT04819542|Device|No bandage|No bandage
16410635|NCT04816513|Drug|Ustekinumab|Ustekinumab will be administered as SC injection.
16410636|NCT04815876|Procedure|Transperineal MRI-guided prostate biopsy|Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
16410637|NCT04815876|Procedure|Transrectal MRI-guided prostate biopsy|Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
16410638|NCT04815876|Drug|Antibiotic (prophylaxis)|"For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).
~No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy."
16410640|NCT04814940|Other|MENOPUR Cohort|"Non-interventional
~All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study take place."
16410642|NCT04806100|Device|Malleo-Lok|The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.
16410643|NCT04805190|Behavioral|Cognitive-Behavioral Intervention|This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
16410644|NCT04805190|Behavioral|Pain Education|General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
16410648|NCT04802811|Drug|SHR2150；Placebo|Single dose；SHR2150-dose 4 or Placebo-dose 4
16410649|NCT04802811|Drug|SHR2150；Placebo|Single dose；SHR2150-dose 5 or Placebo-dose 5
16410650|NCT04801368|Procedure|Randomization of two local anesthetics.|Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
16410651|NCT04800523|Device|UroMonitor System|Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis
16410655|NCT04799067|Other|observational study|no study drug involved, observational study.
16410656|NCT04796636|Drug|Sodium Ascorbate|As previously described
16410657|NCT04791319|Drug|Placebo|Placebo will be administered subcutaneously.
16410658|NCT04791319|Drug|Bermekimab|Bermekimab will be administered subcutaneously.
16410659|NCT04791319|Drug|Dupilumab|Dupilumab will be administered subcutaneously.
16410660|NCT04786600|Device|Signatera ctDNA assay|Subjects will be tested with the Signatera ctDNA assay every 2 weeks.
16410661|NCT04786600|Drug|pre-specified sequence of FDA-approved drugs and drug combinations|Subjects will receive treatment with a pre-specified sequence of FDA-approved drugs and drug combinations
16410662|NCT04786457|Biological|Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)|one subcutaneous injection of Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at 0.5 mL of 6.5 x 10^3 PFU/mL
16410663|NCT04784559|Drug|Plitidepsin|"Plitidepsin 2 mg powder is provided as a sterile, preservative-free, and white to off-white lyophilised powder/cake comprising 2 mg plitidepsin and 100 mg mannitol in a single-dose, 10 mL clear type 1 glass vial.
~Solvent for plitidepsin is provided as a sterile, preservative-free, clear, slightly viscous aqueous liquid (4 mL) containing 0.15 mL macrogolglycerol ricinoleate and 0.15 mL/mL ethanol in a single-dose type 1 clear glass ampoule.
~For administration, vial contents are reconstituted by addition of 4 mL of solvent for plitidepsin to obtain a slightly yellowish solution containing 0.5 mg/mL plitidepsin with mannitol, macrogolglycerol ricinoleate and ethanol excipients. The required amount of plitidepsin reconstituted solution is added to an IV bag containing 0.9% sodium chloride injection or 5% glucose for injection and administered as an intravenous infusion over 60 minutes."
16410664|NCT04784559|Drug|Dexamethasone|Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
16410665|NCT04784559|Drug|Remdesivir|Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
16410666|NCT04784559|Drug|Favipiravir|Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
16410667|NCT04782661|Drug|JNJ-70075200|JNJ-70075200 solution or solid formulations will be administered orally.
16410668|NCT04782661|Drug|Placebo|Placebo solution will be administered orally.
16410669|NCT04778644|Drug|CBD|Oral gel capsule CBD
16410670|NCT04778644|Drug|Placebo|Oral gel capsule placebo
16410671|NCT04778046|Drug|Hyperpolarized 129Xe|Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
16410672|NCT04776746|Drug|trofinetide|Study drug is administered twice a day for up to approximately 32 months. Doses may be taken orally or administered by gastrostomy (G) tube. The subject's assigned dose for this study will be the final dose from the antecedent study (ACP-2566-004).
16410673|NCT04776252|Drug|MK-8591A|FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 48 weeks
16410674|NCT04773067|Biological|UB-612|Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.
16410675|NCT04773067|Biological|Placebo|Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.
16410676|NCT04768296|Drug|Berzosertib|Participants with advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed will receive Berzosertib at a dose of 105 milligrams per square meter (mg/m^2) intravenously on Day 2 and Day 5 of each 21-day cycle in DL1 of safety run-in part.
16410677|NCT04768296|Drug|Berzosertib|Participants with relapsed, platinum-resistant SCLC will receive Berzosertib at a dose of 210 mg/m^2 intravenously on Day 2 and Day 5 of each 21-day cycle in DL2 of safety run-in part and main part until disease progression or other criteria for study intervention discontinuation are met.
16410678|NCT04768296|Drug|Topotecan|Participants who have advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed or who have relapsed, platinum-resistant SCLC will receive Topotecan at a dose of 1.25 mg/m^2 intravenously on Days 1 through 5 of each 21-day cycle in DL1 and DL2 of safety run-in part and main part until disease progression or other criteria for study intervention discontinuation are met.
16410679|NCT04767854|Behavioral|OA school|Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
16410680|NCT04767854|Other|Virtual Training mobile health application|Individually tailored home exercise programs delivered through a mobile health application
16410681|NCT04767854|Other|Usual care|Individually tailored exercise programs conducted in weekly supervised individual or group sessions
16410682|NCT04766398|Drug|KHK7791|oral administration
16410683|NCT04766398|Drug|Placebo|oral administration
16410684|NCT04759274|Device|Diuretic Tuner|Mobile device application for diuretic dose titration
16410685|NCT04756271|Biological|SARS-Cov-2 neutralizing antibody titer|Quantitation of SARS-Cov-2 antibody titer at baseline after each dose of the vaccine
16410686|NCT04754594|Biological|BNT162b2|Intramuscular Injection
16410687|NCT04754594|Other|Placebo|Intramuscular Injection
16410688|NCT04753242|Other|Online survey questionnaire|Self-developed questionnaire based on relevant literature, own experience and consultation with participating professional societies. The survey contains 25 questions on structural and process variables regarding psychosocial care structures that psychosocial C&L services have established in acute hospitals in the context of the COVID-19 pandemic, the implementation and use of COVID-19-related services for patients, relatives and staff, special challenges, as well as needs and wishes for the future. Thereby the survey is aiming at the creation of a data basis for improving the structural and process quality of psychosocial care services through psychosocial C&L services in the context of pandemics, especially the COVID-19 pandemic.
16410689|NCT04752358|Genetic|Autologous genetically modified ADP-A2M4CD8 cells|Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
16410690|NCT04751162|Device|Actigraphy device (wearable) and mobile application|Participants will be asked to wear an actigraphy device (wearable) and to install a mobile application on their smartphones (cf. Broderick et al., 2019) for tracking PA, SQ and symptoms for 3 weeks
16410692|NCT04745897|Other|eTB Catalogue of Recommendations (eTB)|eTB Catalogue of Recommendations (eTB)
16410693|NCT04745897|Other|World Health Organization Tuberculosis Website (WHO TB)|World Health Organization Tuberculosis Website (WHO TB)
16410694|NCT04741802|Behavioral|TOPS|weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).
16410697|NCT04740307|Biological|Pembrolizumab/Quavonlimab|Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
16410698|NCT04740307|Drug|Lenvatinib|Lenvatinib 12 mg (body weight [BW] ≥60 kg) or 8 mg (BW <60 kg) administered orally every day (QD).
16410699|NCT04740307|Biological|Pembrolizumab|Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.
16410700|NCT04739800|Drug|Cediranib Maleate|Given PO
16410701|NCT04739800|Biological|Durvalumab|Given IV
16410702|NCT04739800|Drug|Olaparib|Given PO
16410703|NCT04739800|Drug|Paclitaxel|Given IV
16410704|NCT04739800|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16410705|NCT04739800|Drug|Topotecan Hydrochloride|Given IV
16410706|NCT04738487|Biological|Pembrolizumab/Vibostolimab|Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations.
16410707|NCT04738487|Biological|Pembrolizumab|Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations.
16410708|NCT04736706|Biological|Pembrolizumab|Pembrolizumab 400 mg administered Q6W via IV infusion
16410709|NCT04736706|Drug|Belzutifan|Belzutifan 120 mg administered QD via oral tablet
16410710|NCT04736706|Biological|Pembrolizumab/Quavonlimab|Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
16410711|NCT04736706|Drug|Lenvatinib|Lenvatinib 20 mg administered QD via oral capsule
16410712|NCT04736199|Drug|Darolutamide (Nubeqa, BAY1841788)|Coated tablet, oral administration
16410713|NCT04736199|Drug|Placebo|Coated tablet matching Darolutamide in appearance, oral administration
16410714|NCT04736199|Other|Androgen deprivation therapy (ADT)|Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy
16410716|NCT04732221|Drug|MK-5475|MK-5475 (soluble guanylate cyclase stimulator) 380 µg, 100 µg or 32 µg administered as dry powder inhalation
16410717|NCT04732221|Drug|Placebo to MK-5475|Placebo administered as dry powder inhalation
16410718|NCT04725188|Biological|Pembrolizumab/Vibostolimab coformuation|Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
16410719|NCT04725188|Drug|Docetaxel|Docetaxel 75 mg^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3.
16410720|NCT04725188|Drug|Placebo|Normal saline IV infusion Q3W up to approximately 2 years
16410721|NCT04721977|Drug|Tucatinib|Tucatinib 300 mg administered BID via oral tablet
16410722|NCT04721977|Biological|Trastuzumab|Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion
16410723|NCT04721977|Drug|Capecitabine|Capecitabine 1000 mg/m^2 administered BID via oral tablet
16410724|NCT04718636|Drug|Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent)|Daily
16410725|NCT04718636|Drug|CC-99677|Daily
16410726|NCT04716283|Other|Validated questionnaire : The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
~The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness .The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities."
16410727|NCT04710537|Other|AlloDerm|Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.
16410728|NCT04710537|Other|DermACELL|Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.
16410729|NCT04707391|Combination Product|MenABCWY vaccine|2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.
16410730|NCT04707391|Combination Product|Placebo|1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group
16410731|NCT04707391|Biological|MenACWY vaccine|1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group
16410732|NCT04707391|Combination Product|MenB vaccine|2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.
16410733|NCT04707261|Drug|Dapagliflozin|Participants will receive dapagliflozin 10 mg once daily
16410734|NCT04707261|Drug|Placebo|Participants will receive placebo once daily
16410735|NCT04704843|Drug|Guselkumab|Guselkumab will be administered as IV infusion (induction dose) and SC injection.
16410736|NCT04704843|Drug|Placebo|Matching placebo to guselkumab will be administered as IV infusion (induction dose) and SC injection.
16410737|NCT04700124|Biological|Pembrolizumab|200 mg of Pembrolizumab IV infusion, on Day 1 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 Q3W for 13 cycles in postoperative phase (up to approximately 9 months). The total duration of treatment is up to approximately 1 year.
16410738|NCT04700124|Biological|Enfortumab vedotin (EV)|1.25 mg/kg of EV IV infusion, on Day 1 and Day 8 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 and Day 8 Q3W for 5 cycles (each cycle length = 21 days) in postoperative phase (up to approximately 4 months). The total duration of treatment is up to approximately 7 months.
16410739|NCT04700124|Procedure|RC + PLND|Curative intent RC + PLND surgery will be administered to all participants randomized to Arm A and B after completion of preoperative systemic treatment (RC + PLND to be done approximately at 15 weeks from randomization).
16410740|NCT04700124|Drug|Gemcitabine|1000 mg/m^2 of Gemcitabine IV infusion, Day 1 and Day 8 Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
16410741|NCT04700124|Drug|Cisplatin|70 mg/m^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
16410742|NCT04700072|Biological|Pembrolizumab|Administered via IV infusion at a specified dose on specified days
16410743|NCT04700072|Biological|Pembrolizumab/Quavonlimab|Administered via IV infusion at a specified dose on specified days
16410744|NCT04700072|Drug|Lenvatinib|Administered via oral capsule at a specified dose on specified days
16410746|NCT04690595|Biological|BAFFR-CAR T cells|First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-ALL
16410747|NCT04689945|Drug|Morphine|"PREOPERATIVE ANALGESIA: None
~INTRAOPERATİVE ANALGESIA:
~Paracetamol 1000 mg IV
~Morphine 0,1 mg/kg IV
~POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol"
16410748|NCT04689945|Procedure|Erector Spinae Block|"PREOPERATIVE ANALGESIA:
~Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection
~INTRAOPERATİVE ANALGESIA:
~Paracetamol 1000 mg IV
~dexketoprofen 50 mg IV
~POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol"
16410749|NCT04689945|Drug|Control|"PREOPERATIVE ANALGESIA: none
~INTRAOPERATİVE ANALGESIA:
~Paracetamol 1000 mg IV
~Dexketoprofen 50 mg IV
~POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol"
16410750|NCT04686487|Procedure|stereotactic ablative radiotherapy|stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body
16410752|NCT04683692|Device|Magnetic Resonance Imaging (MRI)|Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
16410753|NCT04683692|Other|Laboratory Testing|Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation
16410754|NCT04680910|Drug|Phase I: Propofol infusion - moderate dose|Targeted propofol infusion at a moderate range dose in TRD patients will induce SWA during sedation and augment sleep SWA. Dosage of propofol is determined based upon EEG markers.
16410755|NCT04680910|Diagnostic Test|Electroencephalographic (EEG)|EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG
16410756|NCT04680910|Diagnostic Test|Slow-Wave Activity|Duration of slow waves during sedation will be evaluated using automated approaches. SWA during sedation will be calculated as the total power in the 1-4 Hz frequency band/total time in minutes. SWA during N2/N3 sleep will be calculated as the total power in the 1-4 Hz frequency band/total time in minutes in the N2 and N3 sleep stages. Delta sleep ratio will be computed from the SWA measured during the first and second N2/N3 cycles.
16410757|NCT04676646|Drug|Sodium zirconium cyclosilicate|Investigational medicinal product
16410758|NCT04676646|Drug|Placebo|Placebo comparator
16410759|NCT04676646|Other|Spironolactone|"Background intervention.
~During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained."
16410760|NCT04676633|Drug|STP705|Investigational Product
16410761|NCT04676412|Biological|Pembrolizumab|IV infusion
16410762|NCT04676412|Drug|Lenvatinib|oral capsule
16410763|NCT04676412|Drug|Placebo for lenvatinib|oral capsule
16410764|NCT04673357|Drug|Ustekinumab|Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
16410765|NCT04673357|Drug|Placebo|Matching placebo will be administered as SC injection.
16410766|NCT04671381|Behavioral|Hearing Evaluation|Behavioral thresholds for pure tones will be conducted along with speech perception measures.
16410811|NCT04626518|Biological|MK-4830|Administered via IV infusion at a dose of 800 mg Q3W
16410812|NCT04626518|Drug|Belzutifan|Administered via oral tablet at a dose of 120 mg QD
16410767|NCT04671381|Device|Personal Sound Amplification Product (PSAP) Fitting and Orientation|Study participants will be fitted with binaural PSAPs in addition to receiving information on how to use and care for their devices.
16410768|NCT04671381|Behavioral|Four Weeks of Aural Rehabilitation|Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.
16410769|NCT04671381|Device|Provision of Personal Sound Amplification Products (PSAPs)|Study participants will receive binaural PSAPs. Participants will fit their PSAPs based on manufacturer guidelines without the help of an audiologist.
16410770|NCT04668664|Device|EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)|Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS).
16410771|NCT04667234|Drug|AMG 510|Administered as an oral tablet.
16410772|NCT04662710|Biological|Pembrolizumab|400 mg Q6W by IV infusion
16410773|NCT04662710|Biological|Lenvatinib|Administered PO QD, 8 mg induction/20 mg consolidation.
16410774|NCT04662710|Drug|Oxaliplatin|130 mg/m^2 administered by IV infusion on Day 1 of Weeks 1 and 4 of each Q6W cycle as part of CAPOX chemotherapy, or 85 mg/m^2 administered by IV infusion on Day 1 and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
16410775|NCT04662710|Drug|Capecitabine|1000 mg/m^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy.
16410776|NCT04662710|Drug|Leucovorin (or Levoleucovorin)|Administered by IV infusion at 400 mg/m^2 (leucovorin) or 200 mg/m^2 (levoleucovorin) on Day 1, and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
16410777|NCT04662710|Drug|5-FU|400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous IV infusion administered on Day 1, and Week 1, 3, 5, of each Q2W cycle as part of mFOLFOX6 chemotherapy.
16410778|NCT04660539|Drug|satralizumab|Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
16410779|NCT04660539|Drug|azathioprine (AZA)|Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
16410780|NCT04660539|Drug|mycophenolate mofetil (MMF)|Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
16410781|NCT04660539|Drug|oral corticosteroids|Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
16410782|NCT04655755|Drug|Decitabine and Cedazuridine|Given PO
16410783|NCT04655755|Drug|Venetoclax|Given PO
16410784|NCT04654897|Drug|[14C]-NT-814|120 mg radioactive labeled elinzanetant ([14C]-NT-814) oral suspension containing NMT (not more than) 5.6 MBq (megabecquerel) [14C].
16410785|NCT04652700|Drug|ISL|ISL 60 mg tablet, QM, orally for up to 24 months
16410786|NCT04652700|Drug|FTC/TDF|Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
16410787|NCT04652700|Drug|FTC/TAF|Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
16410788|NCT04652700|Drug|Placebo to ISL|Placebo ISL 0 mg tablets QM, orally for up to 24 months.
16410789|NCT04652700|Drug|Placebo to FTC/TDF|Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months
16410790|NCT04652700|Drug|Placebo to FTC/TAF|Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months
16410794|NCT04644796|Drug|saline 0.9%|Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
16410795|NCT04644796|Drug|Liposomal bupivacaine|Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
16410796|NCT04643769|Drug|ORIN1001|Oral tablet - ORIN1001
16410797|NCT04643769|Drug|Placebo|Oral tablet - placebo
16410798|NCT04643418|Drug|MPB-1734|Administered once daily in a 21-day cycle
16410799|NCT04641962|Drug|Bocidelpar|Oral
16410800|NCT04641962|Drug|Placebo|Oral
16410805|NCT04636216|Behavioral|COPE parent training|Weekly 1.5 hour parent training meetings for eight weeks
16410806|NCT04633447|Drug|Guselkumab|Guselkumab Dose 1 and Dose 2 will be administered IV and SC.
16410807|NCT04633447|Drug|Placebo|Matching placebo will be administered IV and SC.
16410808|NCT04630028|Drug|Ustekinumab Dose Based on BSA and Body Weight|As per BSA and body weight Ustekinumab will be administered SC and IV.
16410809|NCT04630028|Drug|Matching Placebo|Placebo will be administered subcutaneously.
16410810|NCT04626518|Biological|Pembrolizumab|Administered via IV infusion at a dose of 200 mg Q3W or 400 mg Q6W
16410813|NCT04626518|Drug|Lenvatinib|Administered via oral capsule at a dose of 20 mg QD
16410814|NCT04626518|Biological|Pembrolizumab/Quavonlimab|Administered via IV infusion at a dose of 400 mg/25 mg Q6W
16410815|NCT04626518|Biological|Favezelimab/Pembrolizumab|Administered via IV infusion at a dose of 800 mg/200 mg Q3W
16410816|NCT04626479|Biological|Pembrolizumab|Administered via IV infusion at a dose of 400 mg Q6W
16410817|NCT04626479|Biological|Favezelimab/Pembrolizumab|Administered via IV infusion at a dose of 800 mg/200 mg Q3W
16410818|NCT04626479|Drug|Belzutifan|Administered via oral tablet at a dose of 120 mg QD
16410819|NCT04626479|Drug|Lenvatinib|Administered via oral capsule at a dose of 20 mg QD
16410820|NCT04626479|Biological|Pembrolizumab/Quavonlimab|Administered via IV infusion at a dose of 400 mg/25 mg Q6W
16410823|NCT04624243|Drug|MK-8189|MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.
16410824|NCT04624243|Drug|Risperidone|Risperidone administered QD at a dose of 6 mg via oral capsule.
16410825|NCT04624243|Drug|Placebo to MK-8189|MK-8189-matching placebo administered QD via oral tablet.
16410826|NCT04624243|Drug|Placebo to risperidone|Risperidone-matching placebo administered QD via oral capsule.
16410827|NCT04624230|Drug|tofacitinib|Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.
16410828|NCT04624204|Biological|Pembrolizumab 200 mg|Pembrolizumab 200 mg Q3W
16410829|NCT04624204|Biological|Pembrolizumab 400 mg|Pembrolizumab 400 mg Q6W
16410830|NCT04624204|Drug|Pembrolizumab placebo (saline)|Pembrolizumab placebo (saline) Q3W
16410831|NCT04624204|Drug|Pembrolizumab placebo (saline)|Pembrolizumab placebo (saline) Q6W
16410832|NCT04624204|Drug|Olaparib 300 mg BID|Olaparib 300 mg twice daily (BID)
16410833|NCT04624204|Drug|Olaparib matching placebo|Olaparib matching placebo BID
16410834|NCT04624204|Drug|Etoposide 100 mg/m^2|Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
16410835|NCT04624204|Drug|Platinum, investigator's choice|Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
16410836|NCT04624204|Radiation|Standard Thoracic Radiotherapy|Standard Thoracic Radiotherapy
16410837|NCT04624204|Radiation|Prophylactic Cranial Irradiation (PCI)|PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
16410838|NCT04623801|Procedure|Percutaneous Laser Ablation (PLA)|Percutaneous Laser Ablation / PLA will be carried out in a single session by advancing one 21-gauge spinal needle into the target lesions under real time US guidance.
16410839|NCT04620330|Drug|VS-6766|Monotherapy
16410840|NCT04620330|Drug|VS-6766 and Defactinib|Combination therapy
16410841|NCT04616924|Drug|RHB-204|RHB-204
16410842|NCT04616924|Drug|Placebo|Matching placebo to RHB-204
16410843|NCT04616456|Drug|[F-18]PBR06|PET radiopharmaceutical
16410844|NCT04616456|Drug|Verdiperstat|verdiperstat targets microglial inflammation in the brain
16410845|NCT04616274|Drug|Venetoclax|This prospective study will draw blood from every patient to measure the venetoclax blood concentration. After blood concentration analysis by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS), the investigator will report the concentration to clinicians.
16410846|NCT04615949|Drug|Cannabidiol, pharmaceutically produced with < 5 ppm THC|CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
16410847|NCT04615949|Drug|Placebo|Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
16410848|NCT04614337|Drug|LUM-201|Administered orally once daily
16410849|NCT04614337|Drug|rhGH Norditropin® pen (34 µg/kg)|Administered subcutaneously (s.c., under the skin) once daily.
16410850|NCT04613622|Drug|Venetoclax|This prospective study will draw blood from every patient to measure the venetoclax blood concentration. After blood concentration analysis by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS), the investigator will report the concentration to clinicians.
16410851|NCT04607421|Drug|Encorafenib|75 mg capsules
16410852|NCT04607421|Drug|Cetuximab|Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial
16410853|NCT04607421|Drug|Oxaliplatin|Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
16410854|NCT04607421|Drug|Irinotecan|Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial
16410855|NCT04607421|Drug|Leucovorin|Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial
16410856|NCT04607421|Drug|5-FU|Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial
16410857|NCT04607421|Drug|Capecitabine|150 mg or 500 mg Tablet
16410858|NCT04607421|Drug|Bevacizumab|Optional Injection for intravenous use 100 mg/vial or 400 mg/vial
16410859|NCT04604340|Procedure|transradial access for neuroangiography|The choice of right vs left radial artery approach would be determined by the vessels that require the highest quality of imaging (e.g. if the left vertebral artery is key to diagnosis, a left radial approach would be chosen, otherwise a right radial approach would be likely most appropriate) - this decision is at the discretion of the interventionist.
16410860|NCT04604340|Procedure|transfemoral access for neuroangiography|By convention, femoral access will be obtained on the right side, unless there is overlying disease or vessel abnormality detected by ultrasound/Doppler, as is usual clinical practice.
16410861|NCT04602104|Biological|low dose hMSC-Exos|basic treatment and 7 times aerosol inhalation of hMSC-Exos (2.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410862|NCT04602104|Biological|medium dose hMSC-Exos|basic treatment and 7 times aerosol inhalation of hMSC-Exos (8.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410863|NCT04602104|Biological|high dose hMSC-Exos|basic treatment and 7 times aerosol inhalation of hMSC-Exos (16.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410864|NCT04602104|Biological|Dosage 1of hMSC-Exos|basic treatment and 7 times aerosol inhalation of hMSC-Exos (a quarter of MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410865|NCT04602104|Biological|Dosage 2 of hMSC-Exos|basic treatment and 7 times aerosol inhalation of hMSC-Exos (MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410866|NCT04602104|Biological|No hMSC-derived exosomes|basic treatment and 7 times aerosol inhalation of normal saline (at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
16410870|NCT04596150|Drug|CX-2009|Intravenous administration of the CX-2009 of 7 mg/kg administered every 3 weeks (Q3W)
16410871|NCT04596150|Drug|CX-072|Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)
16410872|NCT04596033|Biological|GEN-011|Personalized neoantigen adoptive cell therapy (ACT)
16410873|NCT04596033|Drug|IL-2|Cytokine
16410874|NCT04596033|Drug|Fludarabine|Lymphodepletion drug
16410875|NCT04596033|Drug|Cyclophosphamide|Lymphodepletion drug
16410876|NCT04593940|Drug|Infliximab|study drug or matching placebo
16410877|NCT04593940|Drug|Abatacept|study drug or matching placebo
16410878|NCT04593940|Drug|Remdesivir|Standard of Care
16410879|NCT04593940|Drug|cenicriviroc (closed to enrollment as of 3-Sep-2021)|study drug or matching placebo
16410880|NCT04583735|Biological|TEPEZZA|TEPEZZA is a fully human anti-IGF-1R mAb.TEPEZZA will be provided in single-dose 20mL glass vials as a freeze-dried powder.Each vial of TEPEZZA must be reconstituted with 10 mL of sterile water for injection. Reconstituted TEPEZZA solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration.TEPEZZA will be administered in 100 mL or 250 mL infusion bags (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
16410881|NCT04583735|Drug|Placebo|Placebo (normal saline, 0.9% NaCl) solution will be administered in 100 mL or 250 mL infusion bags per weight based dosing volumes once every 3 weeks
16410882|NCT04583423|Drug|MK-3655|MK-3655 low, middle, or high dose for injection
16410883|NCT04583423|Drug|Placebo|Matching placebo to MK-3655
16410884|NCT04582409|Drug|HSY244|HSY244 concentrate solution for injection via intravenous infusion
16410885|NCT04582409|Other|Placebo|concentrate solution for injection via intravenous infusion
16410886|NCT04573140|Biological|Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)|The Phase I, Stratum 1 dose-escalation study will be performed in up to 28 adult participants using a Bayesian optimal interval (BOIN) design with an initial embedded accelerated titration design (ATD) to efficiently identify the maximally tolerated dose (MTD). For the initial ATD, patients will be enrolled and treated in cohorts of size 1 starting at dose level -4 to dose level -1, and will expand to a cohort size of 3 after the first DLT is observed or at dose level 0. There are 8 dose levels to potentially be assessed including the possibility of 4 dose levels for the ATD and 4 for the BOIN.
16410890|NCT04566003|Drug|[18F]GTP1|Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.
16410891|NCT04566003|Drug|[18F]PI-2620|Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer.
16410892|NCT04563715|Diagnostic Test|HIV counseling and testing|Receive HIV testing risk assessment and advice about risk reduction and future testing.
16410893|NCT04563715|Behavioral|Network intervention|Key individuals are trained to provide advice about regular testing and risk reduction.
16410894|NCT04562792|Drug|Daunorubicin|Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
16410895|NCT04560166|Drug|Naxitamab and GM-CSF in combination with irinotecan and temozolomide|"Irinotecan, solution for infusion (20 mg/mL)
~Temozolomide, capsules (5 mg, 20 mg and 100 mg)
~The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL)
~Sargramostim (GM-CSF), lyophilized 250 µg single use vial (250 µg/vial)"
16410896|NCT04559230|Drug|Sacituzumab Govitecan|Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.
16410897|NCT04558918|Drug|LNP023|Taken Orally b.i.d. Dosage Supplied: 200 mg Dosage form: Hard gelatin capsule Route of Administration: Oral
16410898|NCT04558918|Drug|Eculizumab|"Administered as intravenous infusion every 2 weeks as per the stable regimen, the maintenance dose is a fixed dose.
~Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion"
16410899|NCT04558918|Drug|Ravulizumab|"Administered as intravenous infusion every 8 weeks, the maintenance dose is based on body weight.
~Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion"
16410900|NCT04558840|Procedure|Macromastia|Patients with macromastia seeing the principle investigator (PI) (JMK) at his office at the Outpatient Building, which includes the Outpatient Surgery Center (OSC), in the Department of Plastic Surgery clinic at UT-Southwestern for their initial operative consultation for reduction mammaplasty will be offered enrollment in the trial if they are deemed appropriate surgical candidates, based on the PI's clinical judgement and expertise.
16410901|NCT04555044|Drug|Clinolipid|Lipid injectable emulsion, USP 20%
16410902|NCT04555044|Drug|Intralipid|Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)
16410903|NCT04554043|Drug|SHR7280|treatment
16410904|NCT04554043|Drug|Placebo oral tablet|blank control
16410905|NCT04552288|Drug|Benralizumab|All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
16410906|NCT04546620|Drug|R-CHOP|Arm A patients will receive R-CHOP alone.
16410907|NCT04546620|Drug|R-CHOP + acalabrutinib|Arm B patients will receive R-CHOP in combination with acalabrutinib.
16410908|NCT04546399|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16410909|NCT04546399|Biological|Blinatumomab|Given IV
16410910|NCT04546399|Drug|Cyclophosphamide|Given IV
16410911|NCT04546399|Drug|Cytarabine|Given IT
16410912|NCT04546399|Drug|Dexamethasone|Given PO or IV
16410913|NCT04546399|Drug|Etoposide|Given IV
16410914|NCT04546399|Drug|Hydrocortisone Sodium Succinate|Given IT
16410915|NCT04546399|Drug|Leucovorin Calcium|Given PO and IV
16410916|NCT04546399|Drug|Mercaptopurine|Given PO
16410917|NCT04546399|Drug|Methotrexate|Given IT, PO, and IV
16410918|NCT04546399|Biological|Nivolumab|Given IV
16410919|NCT04546399|Drug|Pegaspargase|Given IM or IV
16410920|NCT04546399|Drug|Thioguanine|Given PO
16410921|NCT04546399|Drug|Vincristine Sulfate|Given IV push or via infusion
16410922|NCT04546009|Drug|Giredestrant|Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
16410923|NCT04546009|Drug|Giredestrant-matched Placebo|Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
16410924|NCT04546009|Drug|Letrozole|Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
16410925|NCT04546009|Drug|Letrozole-matched Placebo|Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
16410926|NCT04546009|Drug|Palbociclib|Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
16410927|NCT04546009|Drug|LHRH Agonist|Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
16410928|NCT04544436|Drug|Ocrelizumab|The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.
16410929|NCT04544436|Drug|Ocrelizumab|Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
16410930|NCT04544436|Drug|Antihistamine|Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
16410931|NCT04544436|Drug|Methylprednisolone|Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
16410933|NCT04543071|Drug|Motixafortide|1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
16410934|NCT04543071|Drug|Cemiplimab|350 mg intravenous (IV) once every 21 days
16410935|NCT04543071|Drug|Gemcitabine|1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
16410936|NCT04543071|Drug|Nab paclitaxel|125 mg/m2 IV on days 1, 8, 14 (every 28 days)
16410939|NCT04527016|Procedure|Microbiota and eosinophils based therapy|"Blood eosinophils ≥3%+ mixed airway microbiota: 3 month course of FP 50 ug twice daily via spacer
~Blood eosinophils<3%+ Moraxella species>40% in airway microbiota: Azithromycin 10mg/kg per day for 3 consecutive days a week for 4 weeks;
~Blood eosinophils ≥3%+ Moraxella species>40% in airway microbiota: 3 month course of FP 50 ug twice daily via spacer and Azithromycin 10mg/kg per day for 3 consecutive days a week for 4 weeks;
~Blood eosinophils<3%+ mixed airway microbiota: intermittent budesonide inhalation suspension (1mg twice daily) and terbutaline inhalation suspension for 7 days during wheeze episode.
~The participants will be followed up for one year after the intervention."
16410940|NCT04527016|Drug|Clinical guidelines based therapy|"The children will be treated as directed by their paediatrician ( The clinical practice is based on the guideline for the diagnosis and optimal management of asthma in children of China 2016).The treatment protocols include:
~regular inhaled FP 50 ug twice daily via spacer for 3 months;
~montelukast(4mg od for 3 months)
~intermittent budesonide inhalation suspension (1mg twice daily for 7 days during wheeze episode).
~The participants will be followed up for one year after the intervention."
16410941|NCT04526574|Biological|Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)|Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
16410942|NCT04526574|Other|Saline|Normal saline for injection
16410943|NCT04526574|Biological|Influenza vaccine|Seasonal inactivated influenza vaccine (SIIV)
16410944|NCT04524611|Drug|Risankizumab|Intravenous (IV) Infusion
16410945|NCT04524611|Drug|Risankizumab|Subcutaneous (SC) Injection
16410946|NCT04524611|Drug|Ustekinumab|Intravenous (IV) infusion
16410947|NCT04524611|Drug|Ustekinumab|Subcutaneous (SC) injection
16410948|NCT04523935|Other|Placebo|Fructose powder identical with the drugs was used
16411892|NCT02135874|Drug|Clofarabine|Given IV
16410949|NCT04523935|Drug|Baclofen, Diazepam, Clonazepam, Trihexyphenidyl, Tetrabenazine, Gabapentin, Topiramate, Lamotrigine, Amitriptyline.|Drugs were used either singly or in combination guided by clinical findings and investigations.
16410950|NCT04515186|Drug|Meglumine Antimoniate|Vials of a 5mL solution. Each vial contains 405 mg of Sb5+ corresponding to 8.1% Sb5+ (81 mg/mL).
16410951|NCT04515186|Drug|Miltefosine|50 mg capsule
16410952|NCT04515186|Device|Thermotherapy machine|Localized Current Field radio-frequency generating device
16410953|NCT04514484|Drug|Cabozantinib S-malate|Given PO
16410954|NCT04514484|Biological|Nivolumab|Given IV
16410955|NCT04512066|Drug|RO6889450|Participants will receive oral RO6889450 QD.
16410956|NCT04512066|Drug|Placebo|Participants will receive oral placebo QD.
16410957|NCT04512066|Drug|Risperidone|Participants will receive oral risperidone QD.
16410958|NCT04507841|Drug|Niraparib|Niraparib was used as 100mg capsules once a day since cycle 1 / day 1. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors (the best in the morning). The patient must swallow all the capsules completely and do not chew the capsules. You may drink water or eat when taking medicine.
16410959|NCT04507763|Drug|Etanercept|Patients with ankylosing spondylitis as provided in real world practice
16410960|NCT04506463|Drug|MM-II dose I|Intra-articular injection
16410961|NCT04506463|Drug|MM-II dose II|Intra-articular injection
16410962|NCT04506463|Drug|MM-II dose III|Intra-articular injection
16410963|NCT04506463|Drug|Placebo|Intra-articular injection
16410964|NCT04506463|Drug|Placebo|Intra-articular injection
16410965|NCT04506463|Drug|Placebo|Intra-articular injection
16410966|NCT04504253|Dietary Supplement|Creatine monohydrate|Creatine monohydrate loose powder
16410967|NCT04504253|Drug|Placebo|Placebo control (dextrose 5mg) matched to creatine monohydrate loose powder
16410968|NCT04503772|Procedure|Preoperative SRS|Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days.
16410969|NCT04503551|Drug|PDS Implant Pre-Filled with 100 mg/mL Ranibizumab|Will be administered as per the schedule described in individual arm.
16410970|NCT04503551|Drug|Intravitreal Ranibizumab 0.5 mg Injection|Will be administered as per the schedule described in individual arm.
16410971|NCT04497324|Biological|Convalescent plasma|Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
16410972|NCT04489771|Drug|Belzutifan|Oral administration
16410973|NCT04489758|Diagnostic Test|X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis|Fluoroscopy will be performed for a complete tidal breath and full exhalation at 5 angles (AP, +/- 36 degrees from AP, and +/- 72 degrees from AP) while the patient's arms are raised overhead. 4Dx XV Ventilation Analysis software will be used to analyze these images. Both groups will also undergo pulmonary function testing and take a questionnaire regarding respiratory symptoms.
16410974|NCT04488419|Drug|ATH-1017|Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
16410975|NCT04488419|Drug|Placebo|Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
16410976|NCT04485260|Drug|KRT-232|administered by mouth
16410977|NCT04485260|Drug|Ruxolitinib|administered by mouth
16410978|NCT04484207|Other|A short video intervention|Three minutes video of a veteran that shares his personal story
16410979|NCT04484207|Other|A vignette intervention|A written description of the content of the video
16410980|NCT04482062|Device|Edwards EVOQUE System|Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
16410981|NCT04482062|Drug|Optimal Medical Therapy|Optimal Medical Therapy
16410982|NCT04468607|Drug|BLYG8824A|BLYG8824A will be administered at a flat dose independent of body weight.
16410983|NCT04459507|Other|No intervention|No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through participant charts and prospective data will be collected in accordance with clinical practice at the participant's clinic visits.
16410984|NCT04457960|Drug|JNJ-66525433|Participants will receive JNJ-66525433 oral capsules.
16410985|NCT04457960|Drug|Placebo|Participants will receive matching placebo oral capsules.
16410987|NCT04439526|Drug|Guselkumab|Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.
16410988|NCT04434469|Drug|RO7297089|RO7297089 will be given via intravenous (IV) infusion
16410989|NCT04433065|Device|Intrepid™ TTVR System|Device: Intrepid™ TTVR System
16410990|NCT04428567|Behavioral|Dual-Task Treadmill exercise + Cognitive Training|The dual-task regimen will include treadmill exercise of 5-10 min warm-up and cool-down, 30 minutes of running towards target heart rate, combined with respond demands with the addition of cognitive tasks. The level of duration and intensity of treadmill exercise will progressively increase over the duration of 6 weeks.
16410991|NCT04428151|Drug|Lenvatinib|20 mg once daily, taken as oral capsules
16410992|NCT04428151|Biological|Pembrolizumab|200 mg 30-minute IV infusion on day 1 of each 21-day cycle
16410993|NCT04428151|Drug|Docetaxel|75 mg/m^2 administered as an IV infusion on day 1 of each 21-day cycle
16410994|NCT04428151|Drug|Capecitabine|1250 mg/m^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
16410995|NCT04428151|Drug|Paclitaxel|80 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
16410996|NCT04428151|Drug|Cetuximab|400 mg/m^2 loading dose, followed by 250 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
16410997|NCT04428151|Drug|Lenvatinib|24 mg once daily, taken as oral capsules
16410998|NCT04424290|Drug|BI 764524|Powder for solution for intravitreal injection.
16410999|NCT04418947|Other|Communication type|Control letter vs. intervention letter
16411000|NCT04414241|Drug|Hydroxychloroquine|A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.
16411893|NCT02135874|Drug|Cytarabine|Given IV
16411001|NCT04409639|Drug|Cobimetinib|Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
16411003|NCT04399486|Other|Physical Therapy|Physical Therapy is a therapeutic exercise, education and functional activities provided on a one to one basis with a licensed Physical Therapist to meet functional goals.
16411004|NCT04399356|Drug|Niclosamide|Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.
16411005|NCT04399356|Drug|Placebo|The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.
16411006|NCT04399356|Other|Telehealth monitoring|In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.
16411007|NCT04398446|Drug|Hemp-based CBD|3x Daily dosing for 12 weeks
16411008|NCT04398446|Other|Placebo oral tablet|3x Daily dosing for 12 weeks
16411009|NCT04397263|Drug|Guselkumab|Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
16411010|NCT04396808|Device|Decipher|The Decipher test (GenomeDx Biosciences) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
16411011|NCT04396808|Device|Prolaris|The Prolaris test (Myriad Genetics, Inc.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
16411012|NCT04396808|Device|Oncotype Dx Genomic Prostate Score (GPS)|The Oncotype Dx GPS test (Exact Sciences corp.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
16411013|NCT04396808|Other|Standard of care (askMUSIC score)|AskMUSIC is a risk calculator based on standard clinical and pathologic variables (https://ask.musicurology.com/) and is generally included as part of routine clinical care.
16411014|NCT04395222|Drug|Tocilizumab|Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
16411015|NCT04395222|Drug|Fludarabine|Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
16411016|NCT04395222|Drug|Melphalan|Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
16411017|NCT04395222|Drug|Anti-thymocyte globulin (rabbit)|Anti-thymocyte globulin (ATG) 1.5 mg/kg
16411018|NCT04395222|Radiation|Total Body Irradiation|Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
16411019|NCT04394858|Drug|Olaparib|Given PO
16411020|NCT04394858|Other|Quality-of-Life Assessment|Ancillary studies
16411021|NCT04394858|Drug|Temozolomide|Given PO
16411022|NCT04389775|Drug|Cohort A|"Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of XW003 on Day 1 after overnight fasting by body weight range:
~Proposed XW003 Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg and 0.6mg respectively for Cohorts A1 to A6.
~Proposed XW003 Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.
~These doses are subject to change following SRC review of each cohort - XW003 dose level will not exceed 2.0 mg."
16411023|NCT04389775|Drug|Placebo A|"Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of volume-matching placebo on Day 1 after overnight fasting by body weight range:
~Proposed Placebo Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg, and 0.6mg respectively for Cohorts A1 to A6.
~Proposed Placebo Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.
~These doses are subject to change following SRC review of each cohort - dose level will not exceed 2.0 mg."
16411024|NCT04389775|Drug|Cohort B|"Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of XW003 (n=8) once weekly for 6 weeks following an overnight fast of at least 10 hours.
~Subject to change following SRC review of each cohort.
~Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.
~At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence."
16411025|NCT04389775|Drug|Placebo B|"Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of matching placebo (n=2) once weekly for 6 weeks following an overnight fast of at least 10 hours.
~Subject to change following SRC review of each cohort.
~Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.
~At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence."
16411067|NCT04355117|Drug|Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.|Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
16411068|NCT04352569|Device|transcranial direct current stimulation|transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic
16411069|NCT04347538|Other|Saline Nasal Irrigation|Saline nasal irrigation BID
16411026|NCT04384276|Other|The Weigh Easy System|By use of a small user-friendly luggage scale, the family can easily and safely obtain a weight within the comfort of their own home. Using the Weigh Easy eClipboard, a message will be sent to the family on a weekly basis via Cerner's Message Center that will include a link. The link will be used by parents to enter and submit the patient's current weight. Upon submission, the weight will be transmitted into the patient's EMR after it's reviewed and accepted by a member of the study team. When the weight is received in the system, an alert will be triggered that will notify the study team of its arrival. While the Weigh Easy eClipboard function does qualify as a device, as the investigators will be making clinical decisions based off of the data received through the form, the device is not being used investigationally on this study. The eClipboard function is a standard part of the Cerner framework and has been previously investigated and vetted by for safety and efficacy.
16411027|NCT04384276|Other|Retrospective Control|No interventions will be administered to the historical control group.
16411029|NCT04382898|Biological|W_pro1|Intravenous bolus injection
16411030|NCT04382898|Drug|Cemiplimab|Intravenous infusion
16411031|NCT04380636|Biological|Pembrolizumab|intravenous (IV) infusion
16411032|NCT04380636|Drug|Olaparib|oral tablets
16411033|NCT04380636|Drug|Placebo for olaparib|oral tablets
16411034|NCT04380636|Drug|Etoposide|IV infusion
16411035|NCT04380636|Drug|Carboplatin|IV infusion
16411036|NCT04380636|Drug|Cisplatin|IV infusion
16411037|NCT04380636|Drug|Paclitaxel|IV infusion
16411038|NCT04380636|Drug|Pemetrexed|IV infusion
16411039|NCT04380636|Radiation|Thoracic Radiotherapy|external beam radiation
16411040|NCT04380636|Drug|Durvalumab|IV infusion
16411041|NCT04378153|Other|Discontinuation of hypertonic saline (HS)|Discontinuation of current hypertonic saline (HS) therapy in Study A during 6-week study period.
16411042|NCT04378153|Other|Continuation of hypertonic saline (HS)|Continuation of current hypertonic saline (HS) therapy in Study A during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%.
16411043|NCT04378153|Other|Discontinuation of dornase alfa (dnase)|Discontinuation of current dornase alfa (dnase) therapy in Study B during 6-week study period.
16411044|NCT04378153|Other|Continuation of dornase alfa (dnase)|Continuation of current dornase alfa (dnase) therapy in Study B during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily).
16411046|NCT04376827|Drug|Guselkumab Dose 1|Participants will receive guselkumab Dose 1 via IV administration.
16411047|NCT04376827|Drug|Placebo|Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.
16411048|NCT04376827|Drug|Guselkumab Dose 2|Participants will receive guselkumab Dose 2 via SC route.
16411049|NCT04376827|Drug|Standard-of-care treatment|Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
16411050|NCT04376762|Drug|Fibrinogen|Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
16411051|NCT04376762|Drug|Cryoprecipitate|Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM).
16411052|NCT04372108|Drug|Ustekinumab|Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study.
16411053|NCT04372108|Drug|Other Biologic Therapies|Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.
16411054|NCT04371861|Device|Peripheral Artery Treatment|Peripheral lesions may be treated by any standard of care methods of treatment.
16411060|NCT04369885|Device|Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter|All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.
16411061|NCT04368455|Behavioral|Virtual Immersive Communication Training on Recommending Immunizations (VICTORI)|An intervention that includes a self-directed app based curriculum and virtual reality simulations, designed to increase the strength and consistency of HPV vaccine recommendations among clinicians.
16411062|NCT04368455|Behavioral|HPV Same Way Same Day App|An intervention that includes a self-directed app based curriculum
16411063|NCT04358068|Drug|Hydroxychloroquine (HCQ)|Administered orally
16411064|NCT04358068|Drug|Azithromycin (Azithro)|Administered orally
16411065|NCT04358068|Drug|Placebo for Hydroxychloroquine|Administered orally
16411066|NCT04358068|Drug|Placebo for Azithromycin|Administered orally
16411070|NCT04347538|Other|Saline with Baby Shampoo Nasal Irrigation|Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
16411071|NCT04345887|Drug|Spironolactone 100mg|2x100 mg spironolactone for 5 consecutive days
16411072|NCT04345887|Drug|Placebo oral tablet|2 x1 placebo tablet
16411079|NCT04339023|Drug|Open-Label Placebo|in addition to Treatment as usual, patients receive placebos without concealment (open-label placebo, OLP)
16411080|NCT04339023|Other|treatment as usual|usual medication intake following minimally invasive TLIF. TAU consists of 3 gram Paracetamol per os a day, a patient-controlled morphine pump (Maximum of 2 milligram (mg) every 12 minutes) and rescue medication (1000 mg of Metamizol, maximum every 6 hours)
16411081|NCT04336722|Drug|Odevixibat|Odevixibat is a small molecule and selective inhibitor of IBAT.
16411082|NCT04336722|Drug|Placebo|Placebo identical in appearance to experimental drug (odevixibat).
16411083|NCT04335214|Other|one to one interview|one to one interviews with older people from moroccon origin in Belgium
16411084|NCT04329702|Behavioral|Coping skills training mobile app with call from CST therapist|The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise.
16411085|NCT04329702|Behavioral|Coping skills training mobile app only|The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided.
16411086|NCT04319276|Drug|Gallium maltolate (500 mg)|This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily.
16411087|NCT04319276|Drug|Gallium maltolate (1,000 mg)|This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily.
16411088|NCT04319276|Drug|Gallium maltolate (1,500 mg)|This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily.
16411089|NCT04319276|Drug|Gallium maltolate (recommended phase 2 dose)|The maximum-tolerated dose (recommended phase 2 dose).
16411090|NCT04318548|Combination Product|Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)|rMenB+OMV will be administered intramuscularly as 1 dose each at day 1 and 61 to subjects in MenB+MenACWY group and MenB group and as 1 dose at day 91 to subjects in MenACWY group, to the deltoid region of the non-dominant arm.
16411091|NCT04318548|Biological|Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)|MenACWY will be administered intramuscularly as 1 dose at day 1 to subjects in MenB+MenACWY group, 1 dose at day 91 for MenB group and as 1 dose at day 1 to subjects in MenACWY group, to the deltoid region of the non-dominant arm.
16411092|NCT04318548|Combination Product|Placebo|Placebo will be administered intramuscularly as 1 dose at day 91 to subjects in MenB+MenACWY group, 1 dose at day 1 to subjects in MenB group and MenACWY group, to the deltoid region of the non-dominant arm.
16411093|NCT04317105|Drug|Copanlisib Hydrochloride|Given IV
16411094|NCT04317105|Biological|Ipilimumab|Given IV
16411095|NCT04317105|Biological|Nivolumab|Given IV
16411099|NCT04316169|Drug|Abemaciclib|150 mg b.i.d
16411100|NCT04316169|Drug|Hydroxychloroquine 200 mg|Dose level: 200 mg b.i.d.
16411101|NCT04316169|Drug|Faslodex|Cohort B will receive Faslodex.
16411102|NCT04316169|Drug|Anastrazole|Cohort A will receive anastrazole or letrozole.
16411103|NCT04316169|Drug|Letrozole|Cohort A will receive anastrazole or letrozole.
16411104|NCT04316169|Drug|Hydroxychloroquine 400 mg|Dose level: 400 mg. b.i.d.
16411105|NCT04316169|Drug|Hydroxychloroquine 600 mg|Dose level: 600 mg b.i.d.
16411106|NCT04312659|Drug|Infliximab|Participants will be observed who were treated with Infliximab.
16411107|NCT04305184|Drug|ASP0598|Topical Solution
16411108|NCT04305184|Drug|Matching Placebo|Placebo Topical Solution
16411109|NCT04305145|Drug|Infliximab|Infusion
16411110|NCT04305145|Drug|Methylprednisolone|Infusion
16411111|NCT04305145|Drug|Prednisone|Orally
16411112|NCT04303156|Drug|Islatravir|Single oral dose of 60 mg Islatravir administered in capsule form
16411113|NCT04300504|Other|observational study|observational study
16411114|NCT04296942|Biological|Brachyury-TRICOM|Every three weeks, until cycle 9, then every 12 weeks: *Recombinant MVA-BN-Brachyury (R2PD): 4 injections of vaccines with 1 given SC in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 108 infectious units (Inf.U). *Recombinant FPV-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 109 Inf.U.
16411115|NCT04296942|Drug|Entinostat|5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
16411116|NCT04296942|Biological|M7824|1800mg via IV infusion q3 weeks on Day 1 of each cycle.
16411117|NCT04296942|Biological|Ado-trastuzumab emtansine|3.6mg/kg via IV infusion q3 weeks on Day 1 of each cycle.
16411119|NCT04286529|Drug|Calcitriol capsules|0.25micrograms, taken daily for eight weeks, orally
16411120|NCT04286529|Drug|Oral Placebo|Placebo will be created to mimic the appearance of the study drug
16411121|NCT04281108|Drug|APT-1011|APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
16411122|NCT04281108|Drug|Placebo oral tablet|Placebo orally disintegrating tablet.
16411123|NCT04271735|Dietary Supplement|Niagen|Subjects will take two capsules of nicotinamide riboside by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.
16411124|NCT04271735|Other|Placebo|placebo capsule to match the active supplement
16411125|NCT04269512|Procedure|lymph node dissection|At least 10 lymph nodes must be removed.
16411128|NCT04249596|Drug|Tianeptine Sodium|At baseline, and following 8 weeks of treatment with tianeptine(12.5 mg, 3x daily), participants will be assessed in a number of procedures to evaluate their emotional and physical pain state and pain stimulus response and the relationship of such states/responses to endogenous opioid signaling. To further assess emotional pain, participants will also undergo fMRI while performing a validated social rejection and social acceptance paradigm known to induce endogenous opioid release in control subjects and blunted release in MDD. Examining both rejection and acceptance is important because the MOR system regulates both social distress and social reward in animals and humans, and tianeptine may also act on abnormal MOR-mediated responses to social acceptance in MDD. Likewise, a second fMRI scan will be used to explore physical pain response using an established thermal pain sensitivity task.
16411129|NCT04248673|Other|carbohydrate reduced bread|Consumption of carbohydrate reduced bread for three months.
16411130|NCT04248673|Other|carbohydrate rich bread|Consumption of carbohydrate rich bread for three months.
16411131|NCT04244552|Biological|ATRC-101|ATRC-101 is an engineered, fully-human IgG1 antibody derived from a naturally-occurring human antibody.
16411132|NCT04244552|Biological|Pembrolizumab|Pembrolizumab (Keytruda®) is a humanized immunoglobulin G4 monoclonal antibody with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
16411133|NCT04244552|Drug|Pegylated liposomal doxorubicin (PLD)|Pegylated liposomal doxorubicin (PLD) is doxorubicin hydrochloride (HCl), an anthracycline topoisomerase inhibitor that can bind DNA and inhibit nucleic acid synthesis. PLD is doxorubicin HCL encapsulated in liposomes formulated with surface-bound methoxypolyethylene glycol
16411134|NCT04242992|Behavioral|CETA|CETA is a modular, multi-problem, flexible psychotherapy approach that trains a lay provider in nine evidence-based CBT elements so providers can treat a variety of common problems, including violence, substance use, depression, anxiety, risky behaviors (sexual, non-adherence), and other trauma-related symptoms. Patients randomized to CETA will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include SMS reminders of their HIV care appointments, similar to the active control group.
16411135|NCT04242992|Other|Short Message Service (SMS) text reminders|Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.
16411136|NCT04241185|Drug|Pembrolizumab|400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
16411137|NCT04241185|Radiation|Conventional Radiotherapy (Bladder only)|64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
16411138|NCT04241185|Radiation|Conventional Radiotherapy (Bladder and pelvic nodes)|64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.
16411139|NCT04241185|Radiation|Hypofractionated Radiotherapy (Bladder only)|55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
16411140|NCT04241185|Drug|Cisplatin|35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
16411141|NCT04241185|Drug|Fluorouracil (5-FU)|5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.
16411142|NCT04241185|Drug|Mitomycin C (MMC)|MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
16411143|NCT04241185|Drug|Gemcitabine|Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
16411144|NCT04241185|Drug|Placebo to Pembrolizumab|Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
16411145|NCT04238091|Drug|Fecal material transfer therapy|"Fecal microbiota transplants will be performed as follows:
~FMP Retention Enema: (FMP 250 mL) Dosage Form: Screened human donor stool, suspended in diluent of 12.5% glycerol and sterile normal saline buffer (0.9% NaCl) standardized to a 5X concentration (1g stool : 5mL diluent ratio), homogenized, filtered to 330 microns and aliquoted to sterile 250mL vessels.
~Route of Administration: Fecal transplant will be performed under medical supervision. Lubricated enema tube will be inserted into rectum and contents expelled into the distal colon with the subject requested to retain material for a target dwell time of 3 to 24 hours with a mean target of 10 hours. Participants will lie in the left lateral decubitus position but if mobility permits will rotate to supine and right lateral decubitus position.
~One half of study subjects will receive a 3 day course of antibiotics prior to fecal transplant, while the other half will not."
16411146|NCT04238091|Procedure|4mm Punch Biopsy of Scalp|For the skin biopsy, the doctor will select an appropriate area on the scalp (or skin) as the biopsy site. The area will then be numbed (anesthetized). The study doctor or his/hers designee will then use a cylindrical instrument with a sharp edge (similar to a small cookie-cutter) to remove a 4mm cylinder of skin (smaller than the size of a pencil eraser). After the skin is removed, the biopsy site will be closed with absorbable stitches when appropriate. Approximately 2 to 4 stitches may be placed at the wound site to improve healing. Multiple skin punch biopsies may be taken throughout the entire length of the study
16411267|NCT04084314|Biological|Erenumab|pre-filled pen (auto-injector)
16411147|NCT04238091|Diagnostic Test|Blood draw|Blood will be collected by a standard venipuncture procedure. 60-80cc of blood will be drawn from a patient per blood draw occurrence. Blood samples will be transferred to the research facility. Samples will be used to either stained with cell surface antibodies for fluorescence acquisition cell sorting (FACS) analysis (FACS experiments will allow for assessment of the subset and activation status of immune cells involved in AA or other cutaneous disorder pathology) or to extract DNA for the purposes of exome or genomic sequencing or genotyping of disease associated genes
16411148|NCT04238091|Procedure|Skin Microbiome sampling|Skin microbiome will be collected using skin swabs at the time of recruitment according to established protocols outlined by the Human Microbiome Project. Sterile (germ-free) techniques will be used for collection of all specimens, with careful avoidance of contamination of collection area by gloved hands. The sites that will be sampled are (in sequence): Lesional AA skin, non-lesional scalp skin, retro-auricular crease, ante-cubital fossa, and anterior nares. Skin surface specimens will be collected with a Catch-All Sample Collection Swab swab that looks similar to a q-tip and is, moistened with sterile solution. Skin will be swabbed approximately 50 times along the scalp, behind your ear and on your arm, and twisted 2 times around the front of the nose.
16411149|NCT04238091|Procedure|Hair Microbiome Sampling|Hair follicle microbiome (bacteria that live in the hair follicle) will be collected as follows: several hairs will be plucked from the scalp at a time using tweezers, once plucked the bulbs of the hairs will be cut using sterile surgical scissors and processed. Approximately 10-15 hairs will be plucked for processing. The number of hairs plucked may be increased depending on the number of hairs containing bulbs. Up to 50 hairs may be plucked, as long as the subject is able to tolerate it. Only several hairs will be plucked at a time in order to minimize pain and discomfort of the procedure.
16411150|NCT04238091|Drug|Pre-FMT Antibiotic Cocktail|For three days prior to the transplant, one half (20) of the subjects enrolled will be treated with antibiotics to reduce the burden of the existing microbiome. The antibiotic regimen will consist of: oral vancomycin 250 mg qid, ciprofloxacin 500 mg bid, and metronidazole 500 mg tid. For subjects who have antibiotic allergies, appropriate antibiotic substitutions will be made. Subjects will stop the antibiotics 48 hours before the fecal transplant.
16411151|NCT04238091|Drug|Bowel Prep|The night before the transplant, all enrolled subjects will take 20 mg of bisacodyl and a large volume bowel preparation (GoLyteley 4000cc). Fecal transplant will be performed under medical supervision. After the transplant, subjects will take 4 mg of loperamide to increase transplant retention.
16411152|NCT04234360|Drug|5 days of systemic corticotherapy (prednisone)|Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
16411153|NCT04234360|Drug|5 days of placebo|Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
16411154|NCT04233879|Drug|DOR/ISL|100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
16411155|NCT04233879|Drug|BIC/FTC/TAF|BIC/FTC/TAF 50/200/25 mg FDC tablet taken once daily by mouth.
16411156|NCT04233879|Drug|Placebo to BIC/FTC/TAF|Placebo tablet matched to BIC/FTC/TAF taken by mouth.
16411157|NCT04233879|Drug|Placebo to DOR/ISL|Placebo tablet matched to DOR/ISL taken by mouth.
16411158|NCT04233216|Drug|ISL|ISL 0.75 mg capsule taken by mouth.
16411159|NCT04233216|Drug|DOR|DOR 100 mg tablet taken by mouth.
16411160|NCT04233216|Drug|DOR/ISL|100 mg DOR/0.75 mg ISL FDC taken by mouth.
16411161|NCT04233216|Drug|Placebo to ISL|Placebo capsule matched to ISL taken by mouth.
16411162|NCT04233216|Drug|Placebo to DOR|Placebo tablet matched to DOR taken by mouth.
16411163|NCT04232228|Other|No intervention|No intervention was used in this study.
16411164|NCT04232124|Behavioral|Hypertension Management Model|"Blood Pressure readings by barbers
~Clinical Pharmacist evaluation and counseling
~Blood pressure measurement
~Point of care basic metabolic panel measurement"
16411165|NCT04231825|Device|Transcranial alternating current stimulation|Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
16411166|NCT04227145|Behavioral|SexHealth Mobile|"It will integrate two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services, and SexHealth a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED). Using a menu of adaptive services, SexHealth Mobile will bring contraceptive care to women with SUD (including a subset of women with OUD), if they wish to receive it, at targeted recovery sites Swope currently partners with."
16411167|NCT04226677|Other|aerobic exercise|Treadmill training is include warming, cooling and training phase according to rating of perceived exertion for participants.
16411168|NCT04226677|Other|Video based exercise|Exergame training include virtual reality games by xbox kinect.
16411169|NCT04226677|Other|Control group|first and last evaluations will be made
16411170|NCT04221945|Biological|Pembrolizumab|IV infusion
16411171|NCT04221945|Drug|Placebo for pembrolizumab|IV infusion
16411172|NCT04221945|Drug|Cisplatin|IV infusion
16411173|NCT04221945|Radiation|External Beam Radiotherapy (EBRT)|Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
16411174|NCT04221945|Radiation|Brachytherapy|Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
16411175|NCT04216589|Drug|Semaglutide|Administered subcutaneously
16411176|NCT04210115|Biological|pembrolizumab|IV infusion
16411177|NCT04210115|Drug|placebo|IV infusion
16411178|NCT04210115|Drug|cisplatin|IV infusion
16411179|NCT04210115|Drug|5-FU|IV infusion
16411180|NCT04210115|Radiation|radiotherapy|external radiation
16411181|NCT04210115|Drug|leucovorin|IV infusion
16411182|NCT04210115|Drug|levoleucovorin|IV infusion
16411183|NCT04210115|Drug|oxaliplatin|IV infusion
16411184|NCT04200937|Device|Tactra Malleable|The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure.
16411499|NCT03632252|Device|Powered ankle prosthesis|This device is a custom designed ankle prosthesis. Motors control force on the device through cables but are not worn by the person.
16411185|NCT04200937|Device|Spectra Penile Prothesis|The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.
16411186|NCT04200937|Device|AMS Ambicor|The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery.
16411187|NCT04199104|Drug|Lenvatinib|Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
16411188|NCT04199104|Drug|Pembrolizumab|Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
16411189|NCT04199104|Drug|Placebo|Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
16411190|NCT04195750|Drug|Belzutifan|Oral tablets
16411191|NCT04195750|Drug|Everolimus|Oral tablets
16411192|NCT04191616|Drug|Carfilzomib|Carfilzomib will be administered intravenously over 30 ± 5 minutes, on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression. A dose of 20 mg/m^2 will be administered on day 1 of cycle 1. All subsequent doses will be 56 mg/m^2. The frequency of carfilzomib administration will be reduced to day 1 and 15 per cycle starting with cycle 13 and continued until progression or end of study.
16411193|NCT04191616|Drug|Dexamethasone|Dexamethasone will be administered at least 30 minutes, but no more than 4 hours prior to carfilzomib on days of carfilzomib administration. Dexamethasone will be administered at a dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle up to progression during cycles 1 to 12. Dexamethasone will be administered at a dose of 20 mg on days 1 and 15 of each 28-day cycle up to progression during cycles 13 onward. For subjects more than or equal to 75 years of age, the dose will be 20 mg during cycles 1 through 12 and 10 mg from cycles 13 onward.
16411194|NCT04191616|Drug|Pomalidomide|Pomalidomide dose will be 4 mg per day orally on days 1 to 21 of each cycle until progression.
16411195|NCT04188405|Drug|Decitabine|Given IV
16411196|NCT04188405|Drug|Ponatinib|Given PO
16411197|NCT04188405|Drug|Venetoclax|Given PO
16411198|NCT04188145|Drug|Fluoropyrimidine|"Option 1: Capecitabine 1250 mg/m2 twice daily (i.e. 2500 mg/m²/d) (D1 to D14, D1 = D22) For frail patients according to investigator evaluation capecitabine dose may be reduced to 1000 mg/m2 twice daily (2000 mg/m²/d).
~Or Option 2: Capecitabine 625 mg/m2 twice daily (i.e. 1250 mg/m²/d) (D1 to D21, D1 = D22) Or Option 3: LV5FU2 simplified (folinic acid 200 mg/m² (or Elvorin 400 mg/m²) IV during 2h followed by 5-FU bolus IV of 400 mg/m² during 10 min and IV continuous 5-FU at 2400 mg/m² during 46h). (D1=D15)."
16411199|NCT04188145|Drug|Bevacizumab|"Option 1 and Option 2 : D1 bevacizumab 7.5 mg/kg IV (D1=D21). See smPCs for infusion time of bevacizumab.
~Or Option 3: D1 bevacizumab 5 mg/kg IV (D1=D15). See smPCs for infusion time of bevacizumab"
16411200|NCT04186637|Drug|ALPN-202|Multiple dose levels and dose regimens of ALPN-202 will be administered
16411201|NCT04183166|Drug|TG4050|Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
16411202|NCT04181606|Drug|Esmolol infusion|The Esmolol loading dose will be 0.4 mg/kg body mass/min administered over the first 3 minutes, followed by a maintenance dose of 0.2 mg/kg body mass/min for the remainder of the protocol (maximum of 60 minutes).
16411203|NCT04181606|Drug|Saline infusion|The Saline loading dose will be 0.4 mg/kg body mass/min administered over the first 3 minutes, followed by a maintenance dose of 0.2 mg/kg body mass/min for the remainder of the protocol (maximum of 60 minutes).
16411204|NCT04181606|Other|Pre exercise baseline|Subject rests quietly while drug infusion begins (3 min loading dose followed by 10 min of maintenance dose) until heart rate and blood pressure stabilize.
16411205|NCT04181606|Other|Isometric handgrip exercise|The subject will grip at 40% of their maximum and maintain that grip until fatigue i.e. inability to maintain required force despite verbal encouragement from a member of the research team who is blinded to the infusion order.
16411206|NCT04181606|Other|Post exercise cuff occlusion|At the point of handgrip fatigue, the subject stops gripping as the cuff is inflated and keeps their arm relaxed for 3 minutes of occlusion.
16411207|NCT04181606|Other|Recovery|Cuff is released, monitoring continues until heart rate and blood pressure return to baseline.
16411208|NCT04177914|Procedure|Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)|Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.
16411209|NCT04177914|Device|Ventriculoperitoneal Shunt|The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.
16411210|NCT04170894|Other|Periods of Apnea|Periods of apnea throughout atrial fibrillation ablation.
16411211|NCT04170894|Other|Control Arm - No Periods of Apnea|Standard of care atrial fibrillation ablation.
16411212|NCT04165070|Biological|Pembrolizumab|IV infusion
16411213|NCT04165070|Drug|Carboplatin|IV infusion
16411214|NCT04165070|Drug|Paclitaxel|IV infusion
16411215|NCT04165070|Drug|Pemetrexed|IV infusion
16411216|NCT04165070|Biological|Vibostolimab|IV infusion
16411217|NCT04165070|Biological|MK-5890|IV infusion
16411218|NCT04165070|Biological|MK-4830|IV infusion
16411219|NCT04161534|Device|KT Tape|in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
16411220|NCT04161534|Device|Arm Sling|An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
16411303|NCT03943303|Radiation|Natural gamma radiation from the monazite sands|Patients selected for the study will have their knee (s) affected by osteoarthrose fully submerged in the monazite beach sand 2 (two) times per week for 30 (thirty) minutes each session at the same location and at the same time of day.
16411221|NCT04160065|Biological|IFx-Hu2.0|"The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
~Therapeutic Classification:
~Immunomodulatory Agent
~Route of Administration:
~Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)
~Mechanism of Action:
~Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.
~Physiological Effect:
~Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses."
16411222|NCT04152382|Drug|LY3462817 - IV|Administered IV
16411223|NCT04152382|Drug|LY3462817 - SC|Administered SC
16411224|NCT04152382|Drug|Placebo - IV|Administered IV
16411225|NCT04152382|Drug|Placebo - SC|Administered SC
16411226|NCT04152382|Drug|LY3509754|Administered orally.
16411227|NCT04152382|Drug|Placebo|Administered orally.
16411228|NCT04146896|Drug|NYX-2925 50 mg|NYX-2925 administered orally
16411229|NCT04146896|Drug|Placebo|Placebo administered orally
16411230|NCT04144140|Drug|E7766|E7766, solution, intratumorally
16411231|NCT04143594|Drug|Oral Lenacapavir|Tablets administered without regard to food
16411232|NCT04143594|Drug|F/TAF|Tablets administered without regard to food
16411233|NCT04143594|Drug|Subcutaneous Lenacapavir|Administered in the abdomen via subcutaneous injections
16411234|NCT04143594|Drug|TAF|Tablets administered without regard to food
16411235|NCT04143594|Drug|BIC|Tablets administered without regard to food
16411236|NCT04143594|Drug|B/F/TAF|Tablets administered without regard to food
16411237|NCT04138394|Drug|Ascorbic Acid|We will conduct a double-blind, randomized controlled pilot trial of 90 patients with severe burns randomly allocated to receive intravenous vitamin C (200 mg/kg/day for 96 hours) or placebo (45 per group). If feasibility is demonstrated in the pilot, a larger phase III component will be conducted and aimed at lowering morbidity and mortality and reducing health care costs in an otherwise very devastating and disabling injury worldwide.
16411238|NCT04138394|Drug|placebo|Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
16411239|NCT04128774|Drug|Dexamethasone|The case group receives dexamethasone based on the clinical indication.
16411240|NCT04124471|Behavioral|Open-ended semi-structured interviews|Semi-structured interviews will explore such key constructs as knowledge/belief about OSAS and PAP therapy, routines and resources that promote or limit PAP use, barriers, self-efficacy, and communication and attitudes about PAP. The interviews will be performed with the parent and that they will be audio-recorded.
16411241|NCT04123366|Drug|Olaparib|Oral tablet
16411242|NCT04123366|Biological|Pembrolizumab|Intravenous infusion
16411243|NCT04108156|Drug|PDS Implant Pre-Filled with 100 mg/mL Ranibizumab|Will be administered as per the schedule described in individual arm.
16411244|NCT04108156|Drug|Intravitreal Ranibizumab 0.5 mg Injection|Will be administered as per the schedule described in individual arm.
16411245|NCT04105868|Other|Neurofeedback|Participants will receive feedback during a computerized task that is based on their own visuocortical activity evoked by attention to negative distractors and task-relevant stimuli on the computer screen.
16411246|NCT04105660|Other|Training for EEG monitoring|Training for reading EEG curves during anaesthesia
16411247|NCT04105660|Other|Standard monitoring|Standard monitoring including clinical parameters and BIS index
16411248|NCT04104321|Drug|Aramchol|Aramchol 300 mg BID
16411249|NCT04104321|Drug|Placebo|Placebo BID
16411250|NCT04103892|Drug|CLE-100|1 tablet of CLE-100 administered once daily
16411251|NCT04103892|Drug|placebo|1 tablet of placebo administered once daily
16411252|NCT04102813|Behavioral|Functional Therapy|It consists in a group of body-mind techniques based on functional theory developed in Italy by prof. Luciano Rispoli. These techniques are oriented to stimulate a diaphragmatic breathing though a thoracic and abdominal manipulation, with the aim to activate the parasympathetic nervous system and therefore reducing inflammation
16411253|NCT04102111|Drug|JNJ-67864238|Participants will receive oral tablets of JNJ-67864238 twice daily.
16411254|NCT04102111|Drug|Placebo|Participants will receive oral tablets of matching placebo twice daily.
16411255|NCT04096820|Biological|Uromune|2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
16411256|NCT04093336|Biological|human umbilical cord mesenchymal stem cells|The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.
16411257|NCT04093336|Biological|Placebo|Placebo
16411258|NCT04093336|Other|standardized treatment|standardized treatment
16411259|NCT04090424|Device|NovoSorb BTM|NovoSorb BTM comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a nonbiodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
16411260|NCT04090424|Procedure|Standard of Care|Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.
16411261|NCT04090034|Procedure|Peptide Receptor Radionuclide Therapy|a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
16411262|NCT04088123|Drug|Ticagrelor Oral Tablet [Brilinta]|A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.
16411268|NCT04082689|Behavioral|Assisted Infant Toilet Training|"The parents learn to sensitively respond to the child's routines and signals of elimination needs.The child's ability to convey the need for bowel and bladder evacuation is enhanced through responsive interaction so that a kind of assisted dryness is developed. The infant is held squatting over a potty or basin, while older children sit on the potty."
16411269|NCT04075266|Drug|Ocrelizumab|"Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.
~Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg"
16411270|NCT04070534|Other|PALS|patient activated learning system
16411271|NCT04056247|Other|Plasma sample collection|Collect at least two plasma samples
16411275|NCT04034927|Drug|Olaparib|Given PO
16411276|NCT04034927|Biological|Tremelimumab|Given IV
16411277|NCT04033445|Drug|Placebo|Participants will receive matching placebo IV or SC.
16411278|NCT04033445|Drug|Guselkumab|Participants will receive guselkumab IV or SC.
16411279|NCT04031716|Behavioral|Meditation|Participants assigned to the Meditation intervention will receive focused attention meditation training preoperatively, and encouraged to meditate for 20 minutes per day before surgery. In the postoperative inpatient period, the participants will be offered standard holistic health care, reinforcement of meditation training, and encouragement to practice at least 20 minutes of guided focused-attention meditation with breath as their focus, utilizing the MUSETM headband for bio-feedback, every day during their hospital stay. They will be asked to continue using the MUSETM neurofeedback-assisted meditation after hospital discharge, until their visit to repeat pain testing, at which time they will return the MUSETM headband.
16411280|NCT04022213|Drug|131 I-omburtamab|Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
16411281|NCT04022213|Radiation|WAP-IMRT|Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks
16411282|NCT04002947|Drug|DA-EPOCH|Vincristine 1.4 mg /m2 (2 mg cap) IV on Day 1, Doxorubicin 10 mg/m2/day CIVI on Days 1-4, Etoposide 50 mg/m2 /day CIVI on Days 1-4, Cyclophosphamide 750 mg/m2 IV on Day 5. Prednisone 60 mg/m2 PO BID is administered daily on Days 1-5 of each cycle. Each cycle is 21 days and drugs will be given for 6 cycles.
16411283|NCT04002947|Biological|Rituximab|Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for 6 cycles.
16411284|NCT04002947|Drug|CHOP|Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg /m2 IV, Vincristine 1.4 mg/m2 (2 mg cap) IV are administered on Day 1 of each 21-day cycle for 6 cycles. Prednisone 40 mg/m2 PO is administered daily on Days 1-5 of each cycle.
16411285|NCT04002947|Drug|Acalabrutinib|Acalabrutinib is administered orally at 100 mg twice a day for 14 days during the window period. During combination therapy, acalabrutinib is administered 100 mg twice daily for the first 10 days for 6 cycles.
16411286|NCT03997240|Procedure|Chiropractic Applied Clinical Neuroscience|Chiropractic Applied Clinical Neuroscience makes use of chiropractic care in addition to application of therapies designed to stimulate multisensory reintegration and cerebellar coordination. The multisensory reintegration and cerebellar therapies make use of the body's own sensory receptors as a target, with the purpose of realigning the brain's interpretation of different afferent signals. Observation of motor and autonomic output patterns during and after sensory stimulation afford the clinician real-time feedback, providing for adaptation of the sensory based protocol.
16411287|NCT03981744|Drug|Ustekinumab 6 mg/kg|Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
16411288|NCT03981744|Drug|Ustekinumab 90 mg|Participants will receive ustekinumab 90 mg SC at Week 8 and every 8 Weeks (q8w) through Week 72 in Group 1 and q8w Week 32 through Week 72 in Group 2.
16411289|NCT03981744|Drug|Placebo IV|Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
16411290|NCT03981744|Drug|Placebo SC|Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
16411291|NCT03976375|Biological|Pembrolizumab|IV infusion of pembrolizumab at 200 mg
16411292|NCT03976375|Drug|Lenvatinib|Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.
16411293|NCT03976375|Drug|Docetaxel|IV infusion of docetaxel at 75 mg/m^2.
16411294|NCT03964415|Biological|Ad26.Mos4.HIV|Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.
16411295|NCT03964415|Biological|Clade C and Mosaic gp140 HIV bivalent vaccine|Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.
16411296|NCT03964415|Biological|Placebo|Participants will receive matching placebo.
16411297|NCT03959787|Other|Educational|Educational pamphlet will be given to intervention group.
16411298|NCT03953898|Drug|Olaparib|Given PO
16411299|NCT03947541|Other|Thoracolumbosacral (TLSO) brace|Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.
16411300|NCT03947541|Other|No Bracing|Participants will not wear a brace in the study.
16411301|NCT03945721|Drug|Niraparib|"Niraparib is a type of drug called a PARP inhibitor, which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring."
16411302|NCT03945721|Radiation|Radiation Therapy|radiation therapy
16411424|NCT03763877|Drug|PXL770|Oral capsule
16411425|NCT03763877|Drug|Placebo Oral Capsule|Oral capsule
16411894|NCT02135874|Drug|Dexamethasone|Given IV
16411304|NCT03943303|Radiation|Normal sands exposure patients|Patients selected for the study will have their knee (s) affected by osteoarthrose fully submerged in the no-monazite beach sand 2 (two) times per week for 30 (thirty) minutes each session at the same location and at the same time of day.
16411305|NCT03942120|Drug|Ustekinumab|Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.
16411306|NCT03941483|Drug|ASP1128|Intravenous
16411307|NCT03941483|Drug|Placebo|Intravenous
16411308|NCT03924895|Drug|Pembrolizumab|Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
16411309|NCT03924895|Procedure|Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])|Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
16411310|NCT03924895|Drug|Enfortumab Vedotin|Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
16411311|NCT03924869|Radiation|Stereotactic Body Radiotherapy (SBRT)|SBRT
16411312|NCT03924869|Biological|Pembrolizumab|IV infusion
16411313|NCT03924869|Drug|Placebo|IV infusion
16411314|NCT03924856|Drug|Pembrolizumab|Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
16411315|NCT03924856|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2, IV infusion on Days 1 and 8 of each 21-day cycle
16411316|NCT03924856|Drug|Cisplatin|Cisplatin 70 mg/m^2, IV infusion on Day 1 of each 21-day cycle
16411317|NCT03924856|Procedure|Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])|Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
16411318|NCT03924856|Drug|Placebo|Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
16411321|NCT03921242|Drug|Metformin|Newly Initiated and regular metformin dosage as prescribed by each patient's medical care provider
16411322|NCT03921242|Drug|Sulfonylurea|Newly initiated and regular sulfonylurea dosage as prescribed by each patient's medical care provider
16411323|NCT03921242|Drug|DPP-4 inhibitor|Newly initiated and regular DPP-4 inhibitor dosage as prescribed by each patient's medical care provider
16411324|NCT03921242|Drug|SGLT2 inhibitor|Newly initiated and regular SGLT2 inhibitor dosage as prescribed by each patient's medical care provider
16411325|NCT03921242|Drug|GLP1 receptor agonist|Newly initiated and regular GLP1 receptor agonist dosage as prescribed by each patient's medical care provider
16411332|NCT03898479|Drug|CTP-543|Twice daily dosing
16411333|NCT03897257|Drug|UHE-103A1 cream|Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
16411334|NCT03897257|Drug|UHE-103A2 cream|Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
16411335|NCT03897257|Drug|UHE-103B cream|Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
16411336|NCT03897257|Drug|UHE-103A1B cream|Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
16411337|NCT03897257|Drug|UHE-103A2B cream|Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).
16411338|NCT03896750|Drug|PA-824|PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
16411339|NCT03896711|Behavioral|MEMORI Corps program|Activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (8 hours per week, 2 or 3 days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide in-home supervision, peer-to-peer companionship, and a evidence-based individualized activity program that focuses on meaningful, engaging and enjoyable activities that match PWD abilities and interests.
16411340|NCT03896711|Other|Augmented Waitlist Control|"Persons with dementia/caregivers will continue any services and supports being used, will receive a free copy of A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom103), written educational materials on management of CG stress/well-being, and bi-weekly check-in calls to answer any questions about the materials. Volunteers randomized to waitlist control will continue with usual activities (volunteer or other), and will receive additional written educational materials on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to the Baltimore City Commission on Aging and Retirement Education for volunteering opportunities, and bi-monthly check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm."
16411426|NCT03756454|Biological|Bezlotoxumab|Patients receiving Bezlotoxumab post-operatively.
16411427|NCT03756454|Other|Normal Saline|Placebo
16411895|NCT02135874|Drug|Idarubicin|Given IV
16411343|NCT03896438|Device|Transcranial Direct Current Stimulation (tDCS)|Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.
16411344|NCT03896425|Device|Transcranial direct current stimulation (tDCS)|Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.
16411345|NCT03896152|Drug|LNP023|approximately 2 year of Treatment with LNP023
16411349|NCT03891706|Drug|tumor-specific TCR-T cells|On day 0 and day 14, 0.5-5x10^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.
16411350|NCT03891706|Drug|Interleukin-2|Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .
16411351|NCT03887533|Drug|VTS-270|Intravenous VTS-270 will be administered on a monthly dosing schedule for 12 months. Each participant will receive one of three doses (500, 1000 or 1500 mg/kg). Participants will have the option of receiving monthly 900 mg intrathecal VTS-270 therapy.
16411352|NCT03883607|Drug|Elafibranor 80mg|Once daily oral intake of elafibranor 80 mg during 3 months
16411353|NCT03883607|Drug|Elafibranor 120mg|Once daily oral intake of elafibranor 120 mg during 3 months
16411354|NCT03880019|Drug|Olaparib|Given orally (PO)
16411355|NCT03880019|Drug|Temozolomide|Given PO
16411356|NCT03878095|Drug|Ceralasertib|Given PO
16411357|NCT03878095|Drug|Olaparib|Given PO
16411358|NCT03867916|Behavioral|Patient Navigation Program|Use patient navigation program
16411359|NCT03867916|Other|Quality-of-Life Assessment|Ancillary studies
16411360|NCT03867916|Other|Survey Administration|Ancillary studies
16411361|NCT03867084|Biological|Pembrolizumab|IV infusion of Pembrolizumab 200 mg.
16411362|NCT03867084|Drug|Placebo|IV infusion of 0.9% normal saline.
16411363|NCT03866759|Behavioral|Determine the Incidence and Point Prevalence|Determine the Incidence and Point Prevalence of human immunodeficiency virus (HIV) Infection and the Most Common Sexually Transmitted Infections in Individuals With Sexual Risk Behavior.
16411364|NCT03865589|Diagnostic Test|Ultrasound Elastography|Ultrasound shear wave elastography
16411365|NCT03861117|Procedure|Assisted strategy|Daily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation.
16411366|NCT03861117|Procedure|Non assisted strategy|Daily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation.
16411367|NCT03859427|Drug|Carfilzomib|Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
16411368|NCT03859427|Drug|Carfilzomib|Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
16411369|NCT03859427|Drug|Lenalidomide|Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
16411370|NCT03859427|Drug|Dexamethasone|Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
16411371|NCT03855111|Other|Standard Acupuncture / Moxibustion|Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
16411372|NCT03855111|Other|Individualized (Tailored) Active Acupuncture / Moxibustion|Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
16411373|NCT03850782|Drug|Bimatoprost (SR)|"Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.
~Fellow Eye: Standard of care or Bimatoprost SR."
16411374|NCT03847428|Drug|Durvalumab|Durvalumab IV (intravenous)
16411375|NCT03847428|Drug|Bevacizumab|Bevacizumab IV (intravenous)
16411376|NCT03847428|Other|Placebo|Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking
16411377|NCT03847181|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban at a dose of 15 or 20 mg once daily
16411378|NCT03847181|Drug|Apixaban (Eliquis)|Apixaban at a dose of 2.5 or 5 mg twice daily
16411379|NCT03847181|Drug|Warfarin|Warfarin dose as prescribed by medical practitioner
16411568|NCT03419572|Other|Data collection|Only available evaluations as decided by the investigator based on local clinical practice will be collected.
16411380|NCT03836950|Device|MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)|The coil will be held tangentially to the skull at approximately 45� from the midline. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
16411381|NCT03836950|Device|MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)|The coil will be held tangentially to the skull at approximately 45� from the midline. The sham coil will not release any stimulation, but it will look, feel and sound like the real rTMS
16411382|NCT03833180|Drug|Zilovertamab vedotin|Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.
16411383|NCT03825796|Drug|Enasidenib Mesylate|Given PO
16411384|NCT03825796|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
16411385|NCT03825107|Other|patching|covering the fellow eye with an eyepatch to force use of the amblyopic eye
16411386|NCT03825107|Other|Dichoptic videos|watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
16411387|NCT03818035|Drug|Guselkumab|Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a, 2c, 2d and 3c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
16411388|NCT03818035|Drug|Placebo Injection|Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
16411389|NCT03817853|Drug|Obinutuzumab|Obinutuzumab 1000 mg IV infusion, administered on Day 1, 8 and 15 during Cycle 1, and on Day 1 of subsequent cycles, for 6-8 cycles. Each cycle is 21 or 28 days long depending on the chemotherapy regimen allocated. Maintenance obinutuzumab monotherapy in patients who achieve at least a partial response, after induction therapy will be administered a dose of 1000 mg once every 8 weeks for 2 years or until disease progression (whichever occurs first).
16411390|NCT03817853|Drug|Bendamustine|Bendamustine will be administered on Days 1 and 2 for Cycles 1-6 at a dose of 90 mg/m2/day, for six 28-day cycles.
16411391|NCT03817853|Drug|Cyclophosphamide|Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
16411392|NCT03817853|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle, for six cycles.
16411393|NCT03817853|Drug|Prednisone/Prednisolone/Methylprednisolone|Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
16411394|NCT03817853|Drug|Vincristine|Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
16411395|NCT03814187|Drug|Inclisiran Sodium|Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
16411396|NCT03803332|Behavioral|Exposure Therapy|Psychotherapy including imaginal and in vivo exposure for PTSD.
16411397|NCT03803332|Behavioral|Interpersonal Psychotherapy|Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
16411398|NCT03799289|Behavioral|Behavioral weight loss followed by yoga instruction|12-week standard behavioral weight loss program followed by a 12-week yoga intervention
16411399|NCT03799289|Behavioral|Behavioral weight loss followed by cooking/dietary education instruction|12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
16411400|NCT03797521|Drug|SXC-2023|SXC-2023 oral capsules
16411401|NCT03797521|Drug|Placebo|Matching Placebo oral capsules
16411402|NCT03797326|Biological|Pembrolizumab|Administered as an IV infusion on Day 1 Q3W.
16411403|NCT03797326|Drug|Lenvatinib|Administered orally once a day during each 21-day cycle.
16411404|NCT03793465|Dietary Supplement|tart cherry concentrate|Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
16411410|NCT03789240|Biological|Rituximab|Rituximab is administered at a dose of 375 mg/m2 via IV weekly for the first 4 weeks on Days 1, 8, 15, and 22 during cycle 1. With subsequent cycles (cycles 2-6), rituximab will be dosed only once on Day 1 of the cycle.
16411411|NCT03789240|Drug|Copanlisib|Copanlisib is administered at a fixed dose of 60 mg via IV weekly for the first 3 weeks on Days 1, 8, and 15 followed by a 1-week break (no infusion on Day 22)
16411412|NCT03785405|Drug|sacubitril/valsartan|"Target dose 3.1 mg/kg bid
~Formulations:
~Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)"
16411413|NCT03782376|Drug|Ustekinumab approximately 6 mg/kg (IV)|Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
16411414|NCT03782376|Drug|Placebo (SC)|Participants will receive SC injection of placebo at Week 0.
16411415|NCT03782376|Drug|Placebo (IV)|Participants will receive IV infusion of placebo at Week 0.
16411416|NCT03782376|Drug|Ustekinumab 90 mg (SC) Group 1|Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
16411417|NCT03782376|Drug|Ustekinumab 90 mg (SC) Group 2|Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
16411418|NCT03775408|Device|FAST|Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.
16411419|NCT03765918|Biological|Pembrolizumab 200 mg|200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
16411420|NCT03765918|Radiation|Radiotherapy 60 Gray/day|Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
16411421|NCT03765918|Radiation|Radiotherapy 66 Gray/day|High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
16411422|NCT03765918|Radiation|Radiotherapy 70 Gray/day|Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
16411423|NCT03765918|Drug|Cisplatin 100 mg/m^2|100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle
16411428|NCT03753204|Drug|Furosemide 40 mg|Blood pressure data from the monitors will be downloaded and the average of the systolic blood pressure of the day of salt loading, from 12 noon (end of the saline infusion) until 10 pm will be used as the BP for the salt-loading period of study. The average of the systolic blood pressure of the day of salt depletion, from 12 noon (second dose of furosemide) until 10 pm will be used as the BP for the salt-depleted period of study. A fall in systolic BP ≥10 mm Hg from the salt-loading to the salt-depletion periods will be used to classify a subject as salt sensitive.
16411429|NCT03745144|Drug|Cladribine|Participants will receive cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
16411430|NCT03745144|Drug|Placebo|Participants will receive placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
16411431|NCT03745144|Drug|Microgynon®|Participants will receive Microgynon® tablet once daily for 21 days in treatment period 1 and 2.
16411432|NCT03742895|Drug|Olaparib|Olaparib 300 mg administered BID as two, 150 mg oral tablets.
16411433|NCT03742102|Drug|Durvalumab|Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6 and Arm 7
16411434|NCT03742102|Drug|Capivasertib|Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
16411435|NCT03742102|Drug|Oleclumab|Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1
16411436|NCT03742102|Drug|Paclitaxel|Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
16411437|NCT03742102|Drug|Trastuzumab deruxtecan|Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
16411438|NCT03742102|Drug|Datopotamab deruxtecan|Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
16411439|NCT03733925|Drug|Golimumab|Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.
16411442|NCT03729349|Biological|Golimumab|Participants will receive golimumab as a part of clinical practice.
16411443|NCT03725332|Behavioral|Telemedicine|Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance abuse counselors, perinatal nurse educators, and/or Peer Health Specialists. Consultations will occur every two weeks until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
16411444|NCT03725332|Behavioral|Group Care|Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator and community-based peer support specialist. Small group care meetings will occur every two weeks until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1)Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
16411445|NCT03725059|Biological|Pembrolizumab (K)|IV infusion Q3W
16411446|NCT03725059|Drug|Placebo (P)|Normal saline or dextrose IV infusion Q3W
16411447|NCT03725059|Drug|Paclitaxel (X)|IV infusion QW
16411448|NCT03725059|Drug|Doxorubicin (A)|IV infusion Q3W
16411449|NCT03725059|Drug|Epirubicin (E)|IV infusion Q3W
16411450|NCT03725059|Drug|Cyclophosphamide (C)|IV infusion Q3W
16411451|NCT03725059|Drug|Endocrine therapy|Variable endocrine therapy for up 10 years
16411452|NCT03725059|Radiation|Radiation therapy|Variable radiation therapy per local standard of care
16411453|NCT03725059|Procedure|Surgery|Surgery for breast cancer
16411454|NCT03712943|Drug|Regorafenib|Regorafenib orally 80 mg daily for 21 days (3 weeks on, 1 week off).
16411455|NCT03712943|Drug|Nivolumab|Nivolumab 240 mg administered intravenously every 2 weeks.
16411456|NCT03712605|Other|Best Practice|Receive standard of care observation
16411457|NCT03712605|Biological|Pembrolizumab|Given IV
16411458|NCT03712605|Radiation|Radiation Therapy|Undergo radiation therapy
16411459|NCT03711032|Biological|Pembrolizumab|Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization
16411460|NCT03711032|Biological|BCG|BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
16411461|NCT03707925|Procedure|Cone-Beam Computed Tomography|Undergo CBCT
16411462|NCT03707925|Procedure|Conventional Surgery|Undergo standard resection
16411463|NCT03707925|Procedure|Laser Ablation|Undergo bronchoscopic laser ablation
16411464|NCT03695068|Behavioral|RISE Intervention|Described in Arms description.
16411465|NCT03679611|Drug|Sugammadex Sodium|Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
16411466|NCT03679611|Drug|Neostigmine|neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
16411498|NCT03635112|Drug|TD-1473|TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.
16411896|NCT02135874|Biological|Rituximab|Given IV
16411897|NCT02135874|Drug|Sorafenib|Given PO
16411467|NCT03677947|Behavioral|Exposure and response prevention|ERP is a treatment developed to help people confront their fears based on the rationale that exposure to feared objects, activities, or situations in a safe environment helps reduce fear and decrease avoidance. During the treatment, participants will engage in these exposures to feared stimuli within and between sessions according to hierarchies developed during the initial evaluation sessions, and refrain from engaging in compulsive behaviour until their anxiety subsides (i.e. ritual prevention). Exercises will consist of both exposure in vivo (i.e. exposure in real life situations) and/or imaginal exposure according to recommendations.
16411468|NCT03677947|Other|Inference-based cognitive therapy|The treatment primarily targets the dysfunctional reasoning that gives rise to obsessional doubts and overvalued ideas. IBCT does not include exposure in vivo, but instead, aims to bring resolution to the initial obsessional doubt or overvalued idea by showing the participant that the obsession is the result of incorrect reasoning.
16411469|NCT03677934|Drug|PDS Implant filled with 100 mg/mL Ranibizumab|Will be administered as per the schedule described in individual arm.
16411470|NCT03677934|Drug|Intravitreal Injections of 10 mg/mL Ranibizumab|Will be administered as per the schedule described in individual arm.
16411471|NCT03673774|Device|cardiac impedancemetry|The cardiac output is measured by impedance measurement at rest and during the walking test.
16411472|NCT03671434|Behavioral|Research-to-Policy Collaboration|The RPC is a behavioral intervention through which RPC Researchers and RPC Congressional Offices are prepared and matched for collaboration. Specifically, congressional offices are asked to identify opportunities for researcher engagement in policy efforts, researchers with expertise related to policy opportunities are identified and prepared to collaborate with congressional offices, researchers and congressional staff are matched for ongoing collaborative partnerships, and both researchers and congressional staff receive ongoing support to facilitate research translation.
16411473|NCT03671434|Behavioral|Light Touch Policy Training|Control Researchers are provided information on policy engagement via email.
16411474|NCT03662542|Drug|Guselkumab Dose 1|Guselkumab Dose 1 will be administered as IV infusion.
16411475|NCT03662542|Drug|Guselkumab Dose 2|Guselkumab Dose 2 will be administered as SC injection.
16411476|NCT03662542|Drug|Golimumab Dose 1|Golimumab Dose 1 will be administered as SC injection.
16411477|NCT03662542|Drug|Golimumab Dose 2|Golimumab Dose 2 will be administered as SC injection.
16411478|NCT03662542|Drug|Placebo|Placebo will be administered.
16411484|NCT03654079|Other|Simulation|Participants assigned to the intervention group will participate in the following simulations: 1) the process that may occur if a baby has a significant drop in heart rate during labor, 2) the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a woman needs a cesarean delivery, 3) the pushing process after a woman becomes completely dilated
16411485|NCT03653611|Other|On-site Practice Assessment|The assessment takes place in three parts; the pre-observation practice overview (conducted with the 2 practice clinicians - 60 minutes), the ½ day practice workflow observation (observation by one member of the Aim 2 research team of common and testing areas used for the respiratory patient). There is no patient engagement and no collection of patient-specific identification or health information), and the post-observation practice summary (conducted with the same 2 practice clinicians - 30 minutes).
16411486|NCT03653611|Other|Clinical Staff Questionnaires|"Written or on-line questionnaires are provided to participating and consented staff personnel at two practice levels -- Non-Prescribing clinical (also known as support) staff and Prescribing (PR) clinical (also known as provider) staff."
16411487|NCT03653611|Other|Patient Opinion Surveys|200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.
16411488|NCT03653611|Other|Modular online COPD Education|Access to free, COPD on-line, continuing education is provided for all clinical staff at each practice. Each module will take 20 minutes or less. Aim 2 clinician participant access and completion of COPD education modules is assessed by clinician questionnaires and focus group item response over 12 months (between months 2 and 14 of Aim 2 timeline).
16411489|NCT03653611|Other|COPD in Primary Care/CAPTURE Introduction Focus Groups|Two 45 to 60-minute focus group discussions occur at each Aim 2 practice. Focus groups are informed by practice demographics, practice assessment data, as well as patient opinion from CAPTURE surveys and past CAPTURE study. Focus group candidate themes and prompts are developed for non-prescribing clinical staff (NPR) and prescribing clinical staff (PR) and are presented at separate on-site focus group sessions to allow more detailed discussion of role responsibility in the context of daily practice workflow.
16411490|NCT03650725|Other|Mandatory Split bowel preparation|Intervention describes the standard of care patient split bowel preparation instructions as mandatory, instead of giving patient instructions with option of choice between split or day before bowel prep.
16411491|NCT03647267|Device|Pneumatic Vitreolysis (C3F8 injection)|Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.
16411492|NCT03647267|Other|Observation|No intervention; sham injection only
16411493|NCT03646383|Procedure|Radiofrequency ablation|The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously
16411494|NCT03642106|Behavioral|Unidos Se Puede|The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
16411495|NCT03640754|Biological|G-CSF|G-CSF injected subcutaneously 3 times (Days 0, 28, 56)
16411496|NCT03640754|Other|Placebo/Saline|Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
16411497|NCT03635112|Drug|Placebo|Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.
16411898|NCT02135874|Drug|Sorafenib Tosylate|Given PO
16411500|NCT03630289|Procedure|Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)|Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.
16411501|NCT03629470|Other|Standard Conservative Treatment|Range of motion exercises, medication and activity modification.
16411502|NCT03629470|Other|Nerve Gliding Exercises|Taught by occupational therapist. These exercises involve motions of the wrist, arm and neck. Subjects will be instructed to perform exercises regularly following the occupational therapists' protocol
16411503|NCT03629314|Other|Educational pamphlet arm|Educational pamphlets will be provided to review and questionnaire will be provided to complete before and after review of the pamphlet
16411504|NCT03609801|Behavioral|ACTV|"Achieving Change Through Values-Based Behavior (ACTV) - pronounced ACTIVE - is a new intervention program for domestic violence offenders. ACTV was developed as a collaboration between researchers, practitioners, and the criminal justice system in the state of Iowa (Zarling, Lawrence, Oregno, 2017). It is based on Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999), which is an evidence-based cognitive-behavioral psychotherapy. ACTV is innovative in two primary ways; first, ACTV applies the ACT model to the treatment of domestic violence, and second, ACTV is specifically designed for use in the correctional setting as part of criminal justice programming."
16411505|NCT03609801|Behavioral|The Duluth Model|The Duluth Model is based on the premise that domestic abuse happens when men believe they have the right to authority over women who are their intimate partners. The Duluth Model Men's Nonviolence Classes help men stop battering and explore the consequences of the violence for themselves, their partner and their children.
16411506|NCT03608436|Procedure|Low pressure pneumoperitoneum|Lowering intra-abdominal pressure during laparoscopic surgery
16411507|NCT03608436|Drug|Rocuronium Bromide|Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block
16411508|NCT03606499|Drug|Ustekinumab|No study treatment will be administered as a part of this study. Participants who are initiating the treatment with ustekinumab, will be observed according to standard clinical practice.
16411509|NCT03600883|Drug|AMG 510|Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation
16411510|NCT03600883|Drug|Anti PD-1/L1|Administered as an intravenous (IV) infusion
16411511|NCT03600883|Drug|Midazolam|Administered as an oral hydrochloride (HCI) syrup
16411512|NCT03599245|Drug|Ocrelizumab|Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
16411513|NCT03597464|Drug|Voclosporin|Calcineurin inhibitor, oral, 23.7 mg BID
16411514|NCT03597464|Drug|Placebo Oral Capsule|Voclosporin placebo, oral, 3 capsules BID
16411515|NCT03596645|Drug|Golimumab|Participants receive subcutaneous (SC) golimumab through Week 50, where doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study.
16411516|NCT03596645|Drug|Infliximab|Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.
16411517|NCT03593590|Drug|Ocrelizumab|Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
16411518|NCT03582371|Procedure|Stand-Up Paddle Rehabilitation|Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool.
16411519|NCT03582371|Procedure|Physiotherapy Rehabilitation|Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.
16411523|NCT03577990|Behavioral|ITEC|As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
16411524|NCT03577990|Behavioral|No ITEC|After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without ITEC. Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
16411525|NCT03557385|Drug|Iopamidol|"aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast
~Rate of 4 mL/sec, volume of 10 cc (left coronary system)
~Rate of 3 mL/sec, volume of 6 cc (right coronary system)."
16411526|NCT03557385|Drug|adenosine|FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes
16411527|NCT03557385|Device|Navvus® Catheter|the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
16411528|NCT03557385|Device|CVi® Contrast Delivery System|The CVi® Contrast Delivery System will be used to deliver the contrast medium
16411529|NCT03556904|Radiation|Ablative Radiation Therapy|Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions.
16411530|NCT03556904|Drug|Hormone therapy or chemotherapy|Current standard of care dosing with standard agents; hormone therapy or chemotherapy.
16411674|NCT03117816|Other|Surveillance|For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.
16411531|NCT03540758|Drug|Diazoxide|"Non-diabetic participants will receive diazoxide at a dose of 4-7 mg/kg (based upon weight) before undergoing the pancreatic clamp study.
~T2D participants will have their blood sugar levels normalized, and will then receive diazoxide at a dose of 4-7 mg/kg (based upon weight) before undergoing the pancreatic clamp study."
16411532|NCT03540758|Drug|Nicotinic acid|T2D participants will have their blood sugar levels normalized and will additionally receive nicotinic acid infusion based on weight (0.01 mg/kg/min) to lower free fatty acid levels before undergoing the pancreatic clamp study.
16411533|NCT03540758|Drug|Placebo|"Non-diabetic participants will receive placebo and undergo the pancreatic clamp study.
~T2D participants will have their blood sugar levels normalized, and will then receive a taste-matched placebo for diazoxide before undergoing the pancreatic clamp study."
16411534|NCT03539744|Drug|Pomalidomide|capsule, oral
16411535|NCT03539744|Drug|Dexamethasone|oral, locally available form
16411536|NCT03539744|Drug|Venetoclax|tablet; oral
16411537|NCT03523858|Drug|Ocrelizumab|Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)
16411538|NCT03523377|Other|prolonged overnight fasting|Adherence to fasting will be estimated by proportion of the 49 nights (7 weeks) with ≥12 hours of fasting as per text message data from the participant. If the participant neglects to text the fasting duration, that night will be considered not adherent (a conservative adherence estimate).
16411539|NCT03520920|Drug|Zanubrutinib|Administered zanubrutinib 160 mg orally (PO) BID continuously
16411540|NCT03520920|Drug|Rituximab|Administered rituximab 375 mg/m^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
16411541|NCT03500237|Behavioral|Team-Guided ICBT|An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. In addition to the online program, a guide from the Online Therapy Unit team will respond within one business day of the client's email. The team of guides consist of registered social workers, psychologists or supervised graduate students, with experience delivering ICBT. Amount of contact will be personalized to participants' needs.
16411542|NCT03500237|Behavioral|Self-Guided ICBT|An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) for persons with chronic conditions course will be delivered to participants. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no psychoeducational support will be provided. A team member from the Unit will contact the participant only if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms).
16411543|NCT03486873|Drug|Pembrolizumab|200 or 400 mg IV infusion
16411544|NCT03486873|Drug|Standard of Care (SOC)|IV infusion or oral tablets
16411545|NCT03486678|Drug|SHR-1210+GEMOX|28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
16411546|NCT03485053|Drug|IOP Injection / MPB-1514|Dilute with 5% Dextrose solution (D5W)
16411547|NCT03481634|Drug|Brolucizumab|Intravitreal injection
16411548|NCT03481634|Drug|Aflibercept|Intravitreal injection
16411549|NCT03478592|Other|reference technique|Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos. Embryon are frozen with a slow freezing.
16411550|NCT03478592|Other|vitrification technique|Vitrification is the new technique to freeze embryons. In this study, the GAVI system will be use for for embryos automatically vitrification
16411551|NCT03477851|Drug|Tramadol Hydrochloride|Tramadol i.m. simultaneous with sciatic nerve block
16411552|NCT03477851|Drug|Placebo|0,9%NaCl i.m. simultaneous with sciatic nerve block
16411553|NCT03476330|Drug|Quercetin (dietary supplement)|Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
16411554|NCT03473366|Device|Tao Mask|All anesthesiologists and CRNAs will view an instructional video on the use of the Tao Mask. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).
16411555|NCT03473366|Device|Standard Mask|Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).Mask ventilation will be scored before and after the standard administration of paralytic medication.
16411556|NCT03456856|Drug|Ivabradine|Film-coated tablets taken orally with food twice a day. Tablets supplied in strengths of 5.0 mg and 7.5 mg. 5.0 tablets were split into equal halves for dosages of 2.5 mg.
16411557|NCT03451851|Drug|Guselkumab|Participants will receive a weight-based dose of guselkumab subcutaneously.
16411558|NCT03451851|Drug|Placebo for guselkumab|Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
16411559|NCT03451851|Drug|Etanercept|Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
16411560|NCT03446573|Drug|DTG + 3TC|DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.
16411561|NCT03446573|Drug|TAF based regimen (TBR)|Subjects will continue to receive their TBR.
16411562|NCT03427619|Drug|OK432|OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total.
16411563|NCT03425643|Biological|Pembrolizumab|200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
16411564|NCT03425643|Drug|Placebo|Normal saline by IV infusion Q3W, given on cycle day 1.
16411565|NCT03425643|Drug|Cisplatin|75 mg/m^2 by IV infusion Q3W, given on cycle day 1.
16411566|NCT03425643|Drug|Gemcitabine|1000 mg/m^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
16411567|NCT03425643|Drug|Pemetrexed|500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
16411569|NCT03412188|Drug|Eltrombopag|Patients who showed no response (platelet count ≤ 20x109/L) initially for 3 months or relapse after 6 months after at least one prior ITP therapy will receive a total daily dose of eltrombopag of (25-50mg/d)
16411570|NCT03412188|Drug|conventional|Patients who are currently receiving conventional lines of treatment (steroids, IVIG, azathioprine, and rituximab, Mycophenolate mofetil) will continue on the same line of treatment
16411571|NCT03407144|Biological|pembrolizumab|2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W
16411572|NCT03407144|Drug|doxorubicin|"25 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
~40 mg/m^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
~25 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)"
16411573|NCT03407144|Drug|vinblastine|"6 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
~6 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)"
16411574|NCT03407144|Drug|dacarbazine|"375 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
~375 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)
~250 mg/m^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
16411575|NCT03407144|Drug|cyclophosphamide|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
16411576|NCT03407144|Drug|vincristine|"1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
~1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
16411577|NCT03407144|Drug|prednisone/prednisolone|"60 mg/m^2/day orally divided in 3 doses on Days 1 to 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
~40 mg/m^2/day orally divided in 3 doses on Days 1 to 15 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)"
16411578|NCT03407144|Drug|bleomycin|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
16411579|NCT03407144|Drug|etoposide|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
16411580|NCT03407144|Radiation|Radiotherapy (RT)|RT administered daily, dose dependent on randomization group and disease response.
16411581|NCT03406962|Drug|MGTA-456|Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.
16411582|NCT03402269|Other|Clavicle fracture injury- observation|The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
16411583|NCT03400943|Drug|Vilaprisan (BAY1002670)|2 mg of Vilaprisan once daily up to 2 x 12 weeks
16411584|NCT03400943|Drug|Placebo|Matching placebo was administered to group B1 and B2.
16411585|NCT03396445|Drug|MK-5890|IV infusion
16411586|NCT03396445|Biological|Pembrolizumab|IV infusion
16411587|NCT03396445|Drug|Pemetrexed|IV infusion
16411588|NCT03396445|Drug|Carboplatin|IV infusion
16411589|NCT03396445|Drug|Nab-paclitaxel|IV infusion
16411590|NCT03388632|Drug|rhIL-15|IL-15 is a stimulatory cytokine that activates the immune system, inducing proliferation of T lymphocytes and NK cells. Administration of recombinant human IL-15 (rhIL-15) has been shown to result in a dramatic increase of circulating CD8+T cells and NK cells; these changes in immune cell populations suggest potential for anti-tumor activity.
16411591|NCT03388632|Drug|Ipilimumab|Ipilimumab is a fully human monoclonal antibody against CTLA-4, a receptor present on the surface of activated T cells that functions as an immune checkpoint. Immune checkpoints pathways typically act to downregulate T cell activity and are co-opted by tumors to allow the malignant cells to evade the immune response. Blocking the engagement of CTLA-4 with ipilimumab allows infiltrating T cells to mount an anti-tumor response. Ipilimumab is approved by the FDA for the treatment of certain patients with melanoma and has shown clinical activity in other tumor types as well.
16411592|NCT03388632|Drug|Nivolumab|Nivolumab is a humanized monoclonal antibody against programmed death 1 (PD-1), a receptor present on the surface of activated T cells that functions as an immune checkpoint. One of the ligands for PD-1, PD-L1, is commonly expressed by tumor cells. Similar to inhibition of the CTLA-4 pathway by ipilimumab, blocking of PD-1/PD-L1 signaling by nivolumab allows infiltrating T cells to mount an an immune response against the tumor. Nivolumab is approved as a single agent for several cancer types, as well as for the treatment of advanced melanoma in combination with ipilimumab.
16411593|NCT03384641|Drug|Bedaquiline 200 mg|Participants will receive bedaquiline 200 mg (2*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses.
16411594|NCT03383016|Other|Lifestyle questionnaires|
16411595|NCT03383016|Diagnostic Test|Prostate Biopsy|Possible follow-up by an urologist at 1 year and 2 years after recruitment. After 2 years, proposal for a 2-year end-of-study prostate biopsy to assess the presence or absence of prostate cancer.
16411596|NCT03375307|Procedure|Biospecimen Collection|Undergo blood collection
16411597|NCT03375307|Drug|Olaparib|Given PO
16411598|NCT03374267|Other|Routine care as per site standard.|Physician's choice according to patient's needs.
16411599|NCT03363035|Drug|Rivaroxaban 2.5 mg|One 2.5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
16411600|NCT03363035|Drug|Rivaroxaban 5 mg|One 5 mg rivaroxaban tablet twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
16411601|NCT03363035|Drug|Enoxaparin|Enoxaparin 1mg/kg twice daily SC until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.
16411602|NCT03362177|Biological|Romiplostim|This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
16411603|NCT03362177|Other|Placebo|Placebo Comparator
16411604|NCT03358706|Drug|Ustekinumab IV Infusion|Participants will receive a single IV infusion dose of ustekinumab (dosage to be decided based on body weight) on Day 8.
16411675|NCT03115021|Device|Active tPCS|A current intensity of 2na and a stimulation frequency range of 6-10 Hz will be used with a peri-auricular ear-clip electrode montage for 20 minutes.
16411605|NCT03358706|Drug|Ustekinumab SC Injection|Participants will receive a Ustekinumab 90 mg SC maintenance dose on Day 64. A second optional maintenance dose may be administered on Day 120 based on participants clinical response assessed by investigator.
16411606|NCT03358706|Drug|Midazolam 2 mg|Participants will receive 2 milligram per milliliter (mg/ml) syrup of midazolam as a component of the Cytochrome P 450 probe cocktail orally.
16411607|NCT03358706|Drug|Warfarin 10 mg|Participants will receive 10 mg tablet of warfarin as a component of the Cytochrome P 450 probe cocktail orally.
16411608|NCT03358706|Drug|Vitamin K 10 mg|Participants will receive 10 mg tablet of vitamin K as a component of the Cytochrome P 450 probe cocktail orally.
16411609|NCT03358706|Drug|Omeprazole 20 mg|Participants will receive 20 mg capsule of omeprazole as a component of the Cytochrome P 450 probe cocktail orally.
16411610|NCT03358706|Drug|Dextromethorphan 30 mg|Participants will receive 30 mg capsule of dextromethorphan as a component of the Cytochrome P 450 probe cocktail orally.
16411611|NCT03358706|Drug|Caffeine 100 mg|Participants will receive 100 mg tablet of caffeine as a component of the Cytochrome P 450 probe cocktail orally.
16411612|NCT03334201|Other|Western Diet|high fat (40%), high sugar (25%) and low fiber (15g/day)
16411613|NCT03334201|Other|Non-Western Diet|low fat (25%), low sugar (15%), high fiber (30g/day)
16411614|NCT03317392|Other|Laboratory Biomarker Analysis|Correlative studies
16411615|NCT03317392|Drug|Olaparib|Given PO
16411616|NCT03317392|Other|Quality-of-Life Assessment|Ancillary studies
16411617|NCT03317392|Radiation|Radium Ra 223 Dichloride|Given IV
16411618|NCT03314155|Diagnostic Test|Cerebral neuroinflammation evaluation|Pet scan following an injection of the radiotracer ([18F]DPA-714), to evaluate the neuroinflammation. MRI to evaluate functional and structural integrities. Blood test to analyze various inflammation marker (IL-6, Tumor Necrosis Factor (TNF) alpha, CRPus, and TSPO). And psychological scales to assess the depressive symptoms.
16411619|NCT03310697|Other|Collection of blood and urine samples|For each child, a toxicological screening will be carried out on the blood and urine for the research of proconvulsive molecules by conventional technique on the one hand and by gas chromatography coupled with a mass spectrograph on the other hand.
16411620|NCT03310697|Other|Clinical examination|The other clinical data, any other biological samples or additional examinations are done under the opinion of the clinician or the neuropediatrics.
16411621|NCT03306615|Drug|Hyaluronidase|1200 units (8 vials) of HYLENEX recombinant, will be diluted with 8 ml of 0.9% Sodium Chloride Injection, USP - Preservative-Free, Diluent in a 1:1 ratio (total volume = 16 mL) and dispensed in two 10 ml syringes (8ml in each syringe) for intramuscular injection.
16411622|NCT03306615|Drug|Placebo|The placebo will consist of 16 ml of 0.9% Sodium Chloride Injection, USP - Preservative-Free, also dispensed in two 10 ml syringes for intramuscular injection. The label will include a statement that the product is limited to investigational use, and the original drug containers will be retained.
16411623|NCT03298945|Drug|Miralax-Gatorade Prep|2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
16411624|NCT03298945|Drug|Golytely|4-L split dose Golytely is the current standard prep at the VA
16411625|NCT03287414|Drug|VAY736|VAY736 administered subcutaneously (s.c.) every 4 weeks
16411626|NCT03287414|Drug|Placebo|Placebo administered s.c. every 4 weeks
16411627|NCT03283033|Behavioral|New salad bar|New salad bar placed in school
16411628|NCT03283033|Behavioral|Marketing|Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)
16411629|NCT03264508|Behavioral|Heat therapy|30 sessions (3-4x per week for 8-10 weeks) of hot water immersion in 40°C water, sufficient to raise body core temperature to 38.5°C.
16411630|NCT03264508|Behavioral|Thermoneutral water immersion|30 sessions (3-4x per week for 8-10 weeks) of hot water immersion in 36°C water to prevent changes in body core temperature >0.2°C.
16411631|NCT03259698|Drug|nPEP|Participants will receive Bictegravir/emtricitabine/tenofovir alafenamide 50/200/25mg (Biktarvy®) one tablet once daily as study drug to complete a 28 day course of PEP.
16411632|NCT03259698|Behavioral|Text Messaging Support|"Text messaging support service ('WelTel'): community-based counselors will provides standardized weekly 'check-in' messages during the participants 12-week course of nPEP follow-up. Participants in the text-message arm will also have the option of receiving generic non-specific automated text reminders of their upcoming appointments in the form of Don't forget about tomorrow."
16411633|NCT03259698|Other|Nurse-Led nPEP|nPEP follow-up is provided by nurse-led care at a local sexual health clinic instead of a hospital-based ID physician.
16411636|NCT03250975|Drug|Budesonide and Azithromycin|Participant with acute laryngeal injury will be randomized at discharge to either a non-drug placebo control group or a medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days.
16411637|NCT03250975|Other|Placebo control of budesonide and azithromycin|placebos of the medications will be given for 14 days in patients randomized to the control group
16411638|NCT03242642|Device|Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)|mitral valve replacement
16411639|NCT03242642|Device|Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)|Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
16411640|NCT03219268|Biological|tebotelimab|Anti-PD-1, anti-LAG-3 bispecific DART protein
16411641|NCT03219268|Biological|margetuximab|anti-HER2 monoclonal antibody
16411838|NCT02425787|Behavioral|Interview|The interview will be conducted by study team members and will center around legacy item-related questions.
16411899|NCT02135874|Drug|Vincristine|Given IV
16411642|NCT03218488|Drug|Ustekinumab|Participants will not receive any intervention as part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice (patients should either start therapy with ustekinumab within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study for the treatment of psoriasis) will be observed for the long-term safety of ustekinumab and the long-term effects of ustekinumab on growth and development.
16411643|NCT03218137|Drug|Adenosine|Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg
16411644|NCT03212274|Drug|Olaparib|Given PO
16411645|NCT03210571|Device|eyeWatch system|The eyeWatch device is composed of an AGDD, a control unit and a draining plate
16411646|NCT03207841|Other|LC/HP|Intervention group will receive 8 weeks of LC/HP diet. The daily LC-HP dietary intervention will include ~30% total energy as protein (1.6 g/kg per day) with a carbohydrate-to-protein ratio <1.5 and fat intake set at ~30% of the total energy intake.
16411647|NCT03204240|Other|Neuromuscular electrical stimulation|NMES-RE will involve concentric/eccentric contractions of the quadriceps from a seated position. Briefly, each session will include four sets of 10 actions evoked using 50 Hz trains of 450 µs biphasic pulses. The protocol will be implemented using surface NMES. Upon completion of the NMES-RE session, participants will be given a short break (10-15 minutes) for recovery before starting aerobic training. NMES aerobic exercise will involve twitch electrical stimulation (pulse duration/interval=200/50 µs) applied to the quadriceps muscle via surface NMES. The current amplitude will set to 175 mA. The training will start with 10 minutes of twitch stimulation at 2 Hz. After the first weeks, the duration of the session will progressively increase up to 60 minutes at 10 Hz.
16411648|NCT03190590|Device|tDCS-NeuroConn.|tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training.
16411649|NCT03190590|Device|TMS - Magstim.|TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability
16411650|NCT03190590|Device|Sham tDCS|delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation.
16411651|NCT03179436|Biological|Quavonlimab|Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.
16411652|NCT03179436|Biological|Pembrolizumab|Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).
16411653|NCT03179436|Drug|Pembrolizumab/Quavonlimab|Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).
16411654|NCT03173560|Drug|lenvatinib|lenvatinib capsules.
16411655|NCT03173560|Drug|everolimus|everolimus tablets.
16411656|NCT03151330|Other|Screened Arm|Woman who are identified as high risk will be advised of potential interventions which will include support through care link(nurse education), cervical surveillance, consider vaginal progesterone, low dose aspirin if not already taking.
16411657|NCT03138889|Drug|NKTR-214|NKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability.
16411658|NCT03138889|Drug|Pembrolizumab|Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
16411659|NCT03138889|Drug|NKTR-214|NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
16411660|NCT03138889|Drug|NKTR-214|NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
16411661|NCT03138889|Drug|Cisplatin|Cisplatin will be dosed per the pharmacy manual
16411662|NCT03138889|Drug|Carboplatin|Carboplatin will be dosed per the pharmacy manual
16411663|NCT03138889|Drug|Nab paclitaxel|Nab-paclitaxel will be dosed per local practice and label
16411664|NCT03138889|Drug|Paclitaxel|Paclitaxel will be dosed per local practice and label
16411665|NCT03138889|Drug|Pemetrexed|Pemetrexed will be dosed per the pharmacy manual
16411666|NCT03135535|Device|Avex Footbeat|Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion.
16411667|NCT03134781|Behavioral|DoIT workout|A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management. FFIT was performed 3 times/week with 48 hours recovery between sessions for 40 weeks.
16411668|NCT03134781|Behavioral|DoIT workout - Detraining|A hybrid small-group (5-10 women/session) training modality, that combines interval training, resistance exercise and functional training, performed according to a periodized model of exercise prescription for a 20-week period (3 times/week). Immediately after a 20-week detraining period (no training was performed) was followed.
16411669|NCT03134781|Behavioral|Control - No training|No training was performed during a 40-week period. Participation only in measurements.
16411670|NCT03125902|Drug|Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody|Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
16411671|NCT03125902|Drug|Atezolizumab Placebo|Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
16411672|NCT03125902|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
16411673|NCT03117816|Drug|AOP2014 / Pegylated-Proline-interferon alpha-2b|AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.
16411900|NCT02135874|Drug|Vincristine Sulfate|Given IV
16411676|NCT03115021|Device|Active tDCS|A current intensity of 2mA will be used for 20minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be place over the left prefrontal cortex and the cathode over the right supraorbitofrontal area.
16411677|NCT03115021|Device|Sham tPCS|Sham tPCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tPCS condition and the electrodes placement as well.
16411678|NCT03115021|Device|Sham tDCS|Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
16411679|NCT03095885|Other|Test Meal|
16411680|NCT03085810|Drug|Ocrelizumab|Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
16411681|NCT03085316|Device|Investigational device|Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.
16411682|NCT03079999|Drug|Aspirin|Twice daily aspirin
16411683|NCT03079999|Drug|Placebo|Twice daily placebo
16411684|NCT03076554|Drug|Avelumab|Avelumab will be administered at a dose of 10 mg/kg intravenously once every two weeks until disease progression or development of intolerable adverse events.
16411685|NCT03068390|Behavioral|RICHH Intervention|Whole health cardiovascular disease (CVD) self-care risk reduction intervention
16411686|NCT03068390|Behavioral|Usual care|Referral to primary care provider
16411687|NCT03056794|Other|No intervention|This is an observational study. The investigators will collect data about exposure to responses to dietary supplements, medications, and the ketogenic diet.
16411688|NCT03028480|Drug|NUCALA Injection|Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
16411689|NCT03023722|Drug|anetumab ravtansine|Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
16411690|NCT03016312|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
16411691|NCT03016312|Drug|Enzalutamide|Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
16411692|NCT02976714|Other|spontaneous sputum|"CF patients carry a spontaneous sputum that is made in the context of bronchial drainage sessions conducted as part of usual care (inclusion, 6 months, 12 months, 18 months).
~The collection of spontaneous sputum is carried out within the bronchial drainage sessions, which are routinely performed at each visit. The spontaneous sputum is collected in a sterile container. In order not to contaminate the sputum with buccal epithelial cells will be asked patients to rinse the mouth before expectorate."
16411693|NCT02968108|Drug|Ustekinumab|Subjects will receive a single IV administration of ustekinumab (3 mg/kg for subjects <40 kg or 130 mg for subjects >= 40 kg in Group 1 and 9 mg/kg for subjects < 40 kg or 390 mg for subjects >= 40 kg in group 2) at week 0 followed by SC administration of ustekinumab (2 mg/kg for subjects < 40 kg or 90 mg for subjects >= 40 kg at Week 8.
16411694|NCT02961205|Dietary Supplement|Oral Nutritional Supplementation|"Participants randomized to this arm will receive one bottle of Ensure Enlive 2 times per day, for 30 days prior to their cardiovascular surgery, plus continue their usual diet.
~After their CVS and throughout their hospitalization they will continue to receive 2 bottles of Ensure Enlive per day, plus the standard hospital menu (3 meals per day, plus snacks or as ordered by the medical team), ending at hospital discharge."
16411695|NCT02958709|Drug|High-dose: RIF, INH, PZA, EMB|high-dose rifampicin plus standard dose H,Z,E, given for 8 weeks in treatment Arms 1 and 2
16411696|NCT02958709|Drug|High dose: RIF, INH, PZA, LEVO|high-dose rifampicin plus standard dose H,Z, with levofloxacin substituted for ethambutol for 8 weeks in treatment Arm 2
16411697|NCT02958709|Drug|Standard of care: RIF, INH, PZA, EMB|standard doses of R,H,Z,E given for 8 weeks in treatment Arm 3, control arm.
16411698|NCT02957292|Drug|Levonorgestrel (13,5 mg) intrauterine device|
16411699|NCT02957292|Device|Cooper (380mm2) intrauterine device|
16411700|NCT02954224|Other|CPAP treatment|Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3
16411701|NCT02948777|Drug|Evolocumab|
16411702|NCT02947581|Drug|Albendazole and praziquantel|Intervention - PZQ (50 mg/k/d, up to 3600 mg/d, for 15 days), as an add-on to ABZ treatment (15 mg/k/d, up to 800 mg/d for days 1-20, up to 1200 mg/d for days 21-30). In order to maintain the double blind nature of the trial, ABZ placebo will be administered to individuals over 53 kg of weight until completing the equivalent doses in the comparison group.
16411703|NCT02947581|Drug|Albendazole and praziquantel placebo|PZQ placebo in similar doses, given during the initial 15 days of ABZ treatment at standard doses (15 mg/k/d up to 1200 mg/d for 30 days)
16411704|NCT02928406|Drug|Atezolizumab|Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.
16411705|NCT02927873|Biological|RSV (GSK3389245A) low dose formulation vaccine|2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
16411706|NCT02927873|Biological|RSV (GSK3389245A) middle dose formulation vaccine|2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
16411707|NCT02927873|Biological|RSV (GSK3389245A) high dose formulation vaccine|2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
16411708|NCT02927873|Drug|Placebo|2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
16411709|NCT02926144|Device|Laryngoscope with video|Intubation with video-laryngoscope McGrath with use of the video feature
16411710|NCT02926144|Device|Laryngoscope without video|Endotracheal intubation with video-laryngoscope McGrath without use of the video feature
16411839|NCT02407236|Drug|Placebo IV|Placebo will be administered as intravenous infusion.
16411711|NCT02911064|Behavioral|Questionnaires|Questionnaires completed before and after inpatient rehabilitation. Questionnaires ask about daily living activity performance, expectation of how well daily living activities will be performed after completion of inpatient rehabilitation, symptoms experienced in the past 24 hours, and physical, functional, social, and emotional well-being. These questionnaires should take about 15 minutes total to complete.
16411712|NCT02893917|Drug|Cediranib|Given PO
16411713|NCT02893917|Drug|Olaparib|Given PO
16411714|NCT02881320|Drug|B/F/TAF (Adult Strength)|50/200/25 mg FDC tablets administered orally once daily without regard to food
16411715|NCT02881320|Drug|B/F/TAF (Low Dose)|30/120/15 mg FDC tablets administered orally once daily without regard to food
16411716|NCT02881320|Drug|B/F/TAF (TOS)|2 x FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) (total dose 30/120/15 mg) administered orally as TOS, once daily without regard to food
16411717|NCT02881320|Drug|B/F/TAF (TOS)|FDC of bictegravir 15 mg/emtricitabine 60 mg/ tenofovir alafenamide 7.5 mg (B/F/TAF 15/60/7.5 mg) administered orally as TOS, once daily without regard to food
16411718|NCT02881320|Drug|B/F/TAF (TOS)|2 x FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) (total dose 7.5/30/3.75 mg) administered orally as TOS, once daily without regard to food
16411719|NCT02881320|Drug|B/F/TAF (TOS)|FDC of bictegravir 3.75 mg/emtricitabine 15 mg/ tenofovir alafenamide 1.88 mg (B/F/TAF 3.75/15/1.88 mg) administered orally as TOS, once daily without regard to food
16411720|NCT02877134|Drug|JNJ-64304500|Participants will receive JNJ-64304500 Subcutaneously.
16411721|NCT02877134|Drug|Placebo|Participants will receive placebo Subcutaneously.
16411722|NCT02877134|Drug|Ustekinumab|Participants will receive ustekinumab as per the dosing regimen.
16411723|NCT02870309|Biological|Alpha-1 MP|Alpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as α1-antitrypsin
16411724|NCT02869646|Procedure|Procedure: Acupuncture|Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
16411725|NCT02869646|Procedure|Procedure: Sham acupuncture|Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
16411726|NCT02861898|Drug|Intra-arterial Cetuximab|
16411727|NCT02861898|Drug|Intra-arterial Mannitol|
16411728|NCT02861573|Biological|Pembrolizumab 200 mg|IV Q3W
16411729|NCT02861573|Drug|Olaparib 400 mg|Eight 50-mg capsules PO BID
16411730|NCT02861573|Drug|Docetaxel 75 mg/m^2|IV Q3W
16411731|NCT02861573|Drug|Prednisone 5 mg|One 5-mg tablet PO BID
16411732|NCT02861573|Drug|Enzalutamide 160 mg|Four 40-mg capsules, four 40-mg tablets, or two 80-mg tablets PO QD
16411733|NCT02861573|Other|Dexamethasone 8 mg|Premedication for Cohort B given PO at 12, 3, and 1 hours prior to docetaxel infusion Q3W
16411734|NCT02861573|Drug|Olaparib 300 mg|Two 150-mg tablets PO BID
16411735|NCT02861573|Drug|Abiraterone acetate 1000 mg|Two 500-mg or four 250-mg tablets PO QD
16411736|NCT02861573|Drug|Lenvatinib|20 mg PO QD
16411737|NCT02861573|Biological|Pembrolizumab/Vibostolimab coformulation|IV Q3W
16411738|NCT02861573|Drug|Carboplatin|IV Q3W
16411739|NCT02861573|Drug|Etoposide|IV on Days 1, 2 and 3 of each cycle
16411740|NCT02858336|Behavioral|NEA|Neutral Energy Availability: 5-day outpatient intervention of prescribed diet and exercise to elicit an energy availability of 45 kcal/kg LBM day.
16411741|NCT02858336|Behavioral|DEA|Deficient Energy Availability: 5-day outpatient intervention of prescribed diet and exercise to elicit an energy availability of 20 kcal/kg LBM day.
16411742|NCT02849496|Drug|Atezolizumab|Given IV
16411743|NCT02849496|Drug|Olaparib|Given PO
16411744|NCT02849496|Other|Questionnaire Administration|Ancillary studies
16411745|NCT02834780|Drug|H3B-6527|H3B-6527 by mouth once or twice daily at specified doses.
16411746|NCT02831959|Device|NovoTTF-100M device|
16411747|NCT02831959|Other|Best Standard of Care|
16411748|NCT02813889|Device|SmarToyGym|"We aim to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.
~A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture."
16411749|NCT02811783|Drug|Naloxone Hydrochloride Lotion, 0.5%|Topical TID for 2 weeks
16411750|NCT02811783|Drug|Placebo Lotion|Topical TID for 2 weeks
16411751|NCT02806687|Drug|Gene Therapy product CYL-02|"Gene Therapy product CYL 02 = = plasmid DNA encoding SST2 + DCK::UMK genes pre-complexed to linear polyethylenimine.
~Intratumoral injection of the gene therapy product CYL-02 (2,5 ml within the primary tumor under endoscopic ultrasound guidance an under propofol anaesthesia). The intratumoral injection of CYL-02 is followed by three IV infusions of Gemcitabine (1000 mg/m2) at 48 hours and then every week. A second Intratumoral injection of the gene therapy product CYL-02 is performed at a same dosage and volume, 30 days after the first administration followed by three infusions of gemcitabine (1000 mg/m2) according the same rhythm (48 hours and every week) and dose. Patients have infusion of Gemcitabine 3 weeks/month during 6 months (or until progression)."
16411752|NCT02806687|Drug|Gemcitabine|Gemcitabine alone 3 weeks/month during 6 months (or until progression).
16411753|NCT02792192|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in respective arm.
16411754|NCT02792192|Biological|Bacille Calmette-Guérin|For Cohort 1B, BCG will be administered (intravesically) at de-escalated doses. De-escalation will be allowed for up to three dose levels of BCG: full dose (50 mg), 66% of full dose, and 33% of full dose. After the MTD or MAD is determined for Cohort 1B, MTD/MAD will be used for all subsequent participants enrolled into Cohorts 1B, 2, and 3 (provided MAD or MTD is determined to be either full dose or 66% of a full BCG dose).
16411840|NCT02407236|Drug|Placebo SC|Placebo will be administered Subcutaneously.
16411841|NCT02407236|Drug|Ustekinumab IV|Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
16411755|NCT02779855|Biological|Talimogene laherparepvec|Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).
16411756|NCT02779855|Drug|Paclitaxel|Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2.
16411757|NCT02722525|Procedure|Magnetic Resonance Imaging|Undergo treadmill stress CMR
16411758|NCT02722525|Behavioral|Exercise Intervention|Complete treadmill exercise
16411759|NCT02722525|Radiation|Gadopentetate Dimeglumine|Undergo gadopentetate dimeglumine perfusion MRI
16411760|NCT02722525|Procedure|Perfusion Magnetic Resonance Imaging|Undergo gadopentetate dimeglumine perfusion MRI
16411761|NCT02722525|Behavioral|Exercise Intervention|Complete resistive lower extremity exercise
16411762|NCT02722525|Procedure|Spectroscopy|Undergo skeletal muscle PMRS
16411763|NCT02722525|Other|Laboratory Biomarker Analysis|Correlative studies
16411764|NCT02717663|Behavioral|Adaptive Goals|Prescribed goals change daily based on participant's performance
16411765|NCT02717663|Behavioral|Static Goals|Prescribed goals remain the same throughout study
16411766|NCT02717663|Behavioral|Delayed (non-contingent) Incentives|Incentives are provided on bi-monthly basis for participation
16411767|NCT02717663|Behavioral|Immediate Micro-Incentives|Incentives are provided immediately for each goal attained
16411768|NCT02696031|Drug|Secukinumab|Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
16411769|NCT02696031|Drug|Placebo|Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
16411770|NCT02696031|Drug|Secukinumab|150 mg Secukinumab s.c. monthly
16411771|NCT02696031|Drug|Secukinumab|Dose escalation to 300mg at Year 2
16411772|NCT02690649|Other|Health Messaging (Non-Procedural)|Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.
16411773|NCT02688777|Behavioral|Backward Walking Training|Backward Walking Training will occur both on a treadmill and overground. In brief, BWTraining will consist of 20-30 minutes of step training with a Body Weight Support and Treadmill system (BWST), rest periods provided as warranted, with manual assistance provided by trainers, followed by 15 minutes of overground gait training. A 20-30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. Participants will be fitted with a harness around their hips and torso, which will be attached to an overhead support system directly above the treadmill. From a stationary position, the treadmill belt will gradually be increased in speed with intervention trainers assisting participant to step backward with their paretic leg, their non-paretic leg (if needed) and at the hips for weight-shift.
16411774|NCT02678312|Drug|LCZ696|LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), 50 mg, 100 mg, 200 mg dosage strengths
16411775|NCT02678312|Drug|Enalapril|Enalapril will be open label in Part 1 and double blind in Part 2
16411776|NCT02678312|Drug|Placebo of LCZ696|
16411777|NCT02678312|Drug|Placebo of Enalapril|
16411778|NCT02666118|Procedure|Preemptive Interscalene Block - Single Shot|Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
16411779|NCT02666118|Procedure|Postoperative Interscalene Block- Single Shot|Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
16411780|NCT02666118|Procedure|Preemptive Interscalene Block - Catheter|Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
16411781|NCT02666118|Procedure|Postoperative Interscalene Block - Catheter|Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
16411782|NCT02663336|Other|Comparison ABPM with OBPM|No interventions
16411783|NCT02646176|Behavioral|Inpatient rehabilitation|Inpatient rehabilitation includes activities and interventions provided by occupational, physical, therapeutic recreation and speech therapists, and psychologists.
16411784|NCT02632396|Drug|Ixazomib|Given PO
16411785|NCT02632396|Biological|Rituximab|Given IV
16411786|NCT02631577|Drug|Atezolizumab (MPDL3280A) [TECENTRIQ]|Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
16411842|NCT02407236|Drug|Ustekinumab SC|Ustekinumab will be administered as subcutaneously.
16411843|NCT02404155|Drug|Clozapine|
16411844|NCT02389075|Procedure|Pinch biopsies|Biopsies obtained during colonoscopy or flexible sigmoidoscopy.
16411787|NCT02631577|Drug|Lenalidomide|Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
16411788|NCT02631577|Drug|Obinutuzumab|Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.
16411789|NCT02595060|Drug|inhaled molgramostim (rhGM-CSF)|
16411790|NCT02595060|Drug|inhaled placebo|formulated as the active substance without molgramostim
16411791|NCT02576509|Drug|Nivolumab|
16411792|NCT02576509|Drug|Sorafenib|
16411793|NCT02569892|Device|Pascal Retinal Laser Photocoagulator|Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
16411794|NCT02568267|Drug|Entrectinib|TrkA/B/C, ROS1, and ALK inhibitor
16411795|NCT02566993|Drug|Lurbinectedin (PM01183)|
16411796|NCT02566993|Drug|Doxorubicin (DOX)|
16411797|NCT02566993|Drug|Cyclophosphamide (CTX)|
16411798|NCT02566993|Drug|Vincristine (VCR)|
16411799|NCT02566993|Drug|Topotecan|
16411800|NCT02545127|Drug|Merotocin|Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
16411801|NCT02545127|Drug|Placebo|Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
16411802|NCT02540616|Device|Transcranial Electrical Stimulation|A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.
16411803|NCT02536300|Drug|Idelalisib|Idelalisib tablet administered orally
16411804|NCT02525757|Drug|MPDL3280A|"1200 mg by vein every 3 weeks up to 1 year after completing consolidation chemotherapy.
~Group 1: MPDL3280A given after receiving standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period.
~Group 2: MPDL3280A given with standard chemotherapy, and radiation therapy for 6-7 weeks followed by a rest period of 3-4 weeks, during which time participants receive 1 dose of MPDL3280A but no chemotherapy or radiation."
16411805|NCT02525757|Drug|Carboplatin|AUC 2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Carboplatin given at AUC 6 by vein on Days 1 and 22 for 2 cycles.
16411806|NCT02525757|Drug|Paclitaxel|50 mg/m2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Paclitaxel given at 200 mg/m2 on Days 1 and 22 for 2 cycles.
16411807|NCT02525757|Radiation|Radiation Therapy|60-66 Gy in 30-33 fractions administered once-daily on Day 1, 5 days a week, for 6 to 7 weeks.
16411808|NCT02502266|Drug|Cediranib|Given PO
16411809|NCT02502266|Drug|Cediranib Maleate|Given PO
16411810|NCT02502266|Drug|Olaparib|Given PO
16411811|NCT02502266|Drug|Paclitaxel|Given IV
16411812|NCT02502266|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16411813|NCT02502266|Other|Questionnaire Administration|Ancillary studies
16411814|NCT02502266|Drug|Topotecan|Given IV
16411815|NCT02502266|Drug|Topotecan Hydrochloride|Given IV
16411816|NCT02481817|Procedure|Endoscopic dilation of subglottic stenosis|This is accomplished with rigid instruments or inflatable balloons.
16411817|NCT02481817|Procedure|Endoscopic resection of the stenosis|This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.
16411818|NCT02481817|Procedure|Tracheal Resection|Resection of the affected tracheal segment with end-to-end anastomosis
16411826|NCT02462330|Drug|Autologous MSC from bone marrow|After bone-marrow aspiration by an authorized person, MSCs were isolated and cultured during 17±2 days by the French Blood Establishment. Then, patients receive intramyocardial injections of MSCs using the electromechanical NOGA-XP system.
16411827|NCT02462330|Drug|Placebo comparator|injections of human albumin
16411828|NCT02451982|Drug|Cyclophosphamide|200 mg/m2 IV
16411829|NCT02451982|Biological|GVAX pancreatic cancer|5x10^8 cells intradermal injection
16411830|NCT02451982|Drug|Nivolumab|480 mg IV
16411831|NCT02451982|Drug|Urelumab|8 mg IV
16411832|NCT02451982|Drug|BMS-986253|2400 mg IV
16411833|NCT02436759|Drug|RVL-1201|RVL-1201 Ophthalmic Solution 0.1%
16411834|NCT02436759|Drug|RVL-1201 Vehicle Placebo|RVL-1201 Vehicle Placebo
16411835|NCT02436408|Drug|Vismodegib|
16411836|NCT02425787|Behavioral|Interview|"This is a prospective study with a semi-structured in-depth qualitative interview. Interviews will be conducted by the study PI or designee. However, in order to ensure that the interviews are conducted sensitively, the first 10 interviews will be observed and supervised by a clinically credentialed St. Jude faculty member, and an additional 10% of the interviews will be observed after that.
~In order to ensure that the interviewer does not lead the participant, or in turn, that the participant does not feel limited in regards to what they believe is an appropriate or desired response, the semi-structured interview questions are general and intended to produce broad responses in regards to participant experiences."
16411837|NCT02425787|Behavioral|Focus Group|"Focus groups will be conducted with a two-fold purpose in mind:
~With bereaved parents: to validate the findings of the preliminary analyses of the initial interviews &/or to suggest avenues of further inquiry to expand and more deeply define the grief journey of bereaved parents.
~With Hematology/Oncology Fellows: to receive input regarding the applicability and use of the findings during the training and future careers of these medical providers."
16411845|NCT02389075|Procedure|Flexible sigmoidoscopy|Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy
16411846|NCT02367456|Drug|PF-04449913 (Glasdegib)|Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles
16411847|NCT02367456|Drug|Azacitidine|75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
16411848|NCT02339922|Drug|Ixazomib Citrate|Given PO
16411849|NCT02339922|Other|Laboratory Biomarker Analysis|Correlative studies
16411850|NCT02339922|Biological|Rituximab|Given IV
16411851|NCT02315703|Biological|Ad26.Mos.HIV|Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
16411852|NCT02315703|Biological|MVA-Mosaic|Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
16411853|NCT02315703|Biological|gp140 DP Low-dose|The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.
16411854|NCT02315703|Biological|gp140 DP High-dose|The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
16411855|NCT02315703|Drug|Placebo|Normal saline, 0.5 mL injection administered intramuscularly.
16411856|NCT02311582|Biological|MK-3475|-Patients currently on pembrolizumab beyond the 2 year/35 cycle limit at the time of the approval of Amendment 13 (approved 07/28/2021) may continue to receive pembrolizumab unless there is progression, toxicity or agreement by the patient and PI to come off therapy. Participants who discontinue pembrolizumab after receiving 35 doses are eligible for retreatment with pembrolizumab if they progress during follow-up provided they meet the requirements. Participants may receive an additional 17 cycles (12 months) of pembrolizumab during the Second Course Phase (Retreatment).
16411857|NCT02311582|Device|MRI-guided laser ablation|
16411858|NCT02311582|Procedure|Surgical resection/debulking|"Optional
~Standard of care"
16411859|NCT02311582|Procedure|Biopsy|"If no surgical resection/debulking
~Phase II patients only"
16411860|NCT02311582|Procedure|Blood draw for research purposes|"Phase II patients only
~Drawn prior to MLA or biopsy/surgical resection procedure, and immediately prior to each the first dose of MK-3475. Subsequently, research blood will be drawn at doses 2, 4, 6, 9, 18, 36, and at the end of treatment"
16411861|NCT02311582|Procedure|Cervical lymph node fine needle aspiration|"Optional
~Time of surgical procedure and 6 weeks +/- 1 week after surgical procedure"
16411862|NCT02307942|Procedure|Gastric banding|The bariatric procedure is a gastric banding under general anesthesia with all the centres using the same surgical procedure (harmonized by group meetings). The laparoscopic surgical procedure has been described. The ERAS protocol will be applied in each centre. The inflation of the band will follow the procedures described by 0'Brien. The patients will attend a group education session before surgery, during which the eating behaviour with a band will be explained and practiced. Then after surgery, the routine procedure is applied.
16411863|NCT02277444|Drug|Golimumab|Golimumab 80 mg/m^2 IV infusion at Weeks 0, 4, and every 8 weeks through Week 244. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m^2 every 8 weeks after completion of the Week 252 assessments.
16411864|NCT02277444|Drug|Methotrexate|Methotrexate BSA-based dose (10 to 30 mg/m^2 per week for participants with BSA <1.67 m^2, or minimum of 15 mg/week for participants with BSA >=1.67 m^2) weekly at least through Week 28.
16411865|NCT02231749|Biological|Nivolumab|
16411866|NCT02231749|Biological|Ipilimumab|
16411867|NCT02231749|Drug|Sunitinib|
16411868|NCT02229344|Other|No Intervention|Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.
16411869|NCT02227238|Drug|DTG|DTG is supplied as 50 mg tablets
16411870|NCT02227238|Drug|LPV/RTV|LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV
16411871|NCT02227238|Drug|Two NRTIs|Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC
16411872|NCT02219815|Behavioral|Prehab Intervention|Pre-operative, structured exercise intervention.
16411873|NCT02195479|Drug|Velcade|Participants will receive velcade 1.3 mg/m^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9.
16411874|NCT02195479|Drug|Melphalan|Participants will receive melphalan 9 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.
16411875|NCT02195479|Drug|Prednisone|Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.
16411876|NCT02195479|Drug|Daratumumab IV|Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study .
16411877|NCT02195479|Drug|Dexamethasone|Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute.
16411878|NCT02195479|Drug|Daratumumab SC|Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC.
16411901|NCT02076009|Drug|Daratumumab|Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.
16411902|NCT02076009|Drug|Lenalidomide|Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
16411903|NCT02076009|Drug|Dexamethasone|Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 18.5).
16411904|NCT02064764|Device|Renal nerve denervation|
16411905|NCT02064764|Device|Cryoablation|
16411906|NCT02047474|Drug|oxaliplatin|Given IV
16411907|NCT02047474|Drug|leucovorin calcium|Given IV
16411908|NCT02047474|Drug|irinotecan hydrochloride|Given IV
16411909|NCT02047474|Drug|fluorouracil|Given IV
16411910|NCT02047474|Procedure|therapeutic conventional surgery|Undergo surgical resection
16411911|NCT02047474|Other|laboratory biomarker analysis|Correlative studies
16411912|NCT02031419|Drug|CC-122|2mg or 3 mg administered orally once daily
16411913|NCT02031419|Drug|CC-223|20mg or 30mg administered orally once daily.
16411914|NCT02031419|Drug|Rituximab|375 mg/m2 administered intravenously once every 28 days
16411915|NCT02031419|Drug|CC-122|2mg or 3mg administered orally once daily.
16411916|NCT02031419|Drug|CC-292|500 mg twice a day administered orally.
16411917|NCT02031419|Drug|Rituximab|375 mg/m2 administered intravenously once every 28 days
16411918|NCT02031419|Drug|CC-223|20mg or 30mg per day administered orally daily.
16411919|NCT02031419|Drug|CC-292|500 mg twice a day administered orally.
16411920|NCT02031419|Drug|Rituximab|375 mg/m2 administered intravenously once every 28 days
16411921|NCT01989897|Drug|saline with 1mg/ml Histamine base|
16411922|NCT01989897|Drug|diluent, saline with HSA--phenol|
16411923|NCT01987726|Other|cytology specimen collection procedure|Undergo collection of CTCs for NGS and FMI testing, respectively.The most recent tumor sample collected from the patient with enough tissue to perform NGS testing will be selected. Tumor from a metastatic or recurrent cancer lesion is preferred but not required. Tumor collection is for standard of care purposes and thus not detailed in this protocol.For each tissue specimen, a representative H&E stained section will be evaluated by a qualified pathologist to confirm the histopathological diagnosis of cancer and to make a quantitative estimate of the proportion of the specimen that is tumor-related cells and the proportion that is non-tumor cells.
16411924|NCT01987726|Other|laboratory biomarker analysis|2 tubes of 7.5 mL blood samples each will be collected at time tumor tissue is sent to FMI and sent to Cynvenio Biosystems, Inc for CTC isolation and analysis. Patient CTCs will be recovered using Cynvenio CTC flow cell technology (Cynvenio Biosystems, Inc.) and enumerated using a combination of CD45, DAPI and cytokeratin staining.1 DNA will be isolated from CTCs and amplified using Φ-29 whole genome amplification (GE Healthcare). Sequencing to be performed by FoundationOne™ protocol.
16411925|NCT01962636|Drug|Fludarabine|25 mg/m^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.
16411926|NCT01962636|Drug|Cyclophosphamide|60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.
16411927|NCT01962636|Radiation|Total Body Irradiation|165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.
16411928|NCT01962636|Drug|Cyclosporine A|Cyclosporine A (CSA) will start day -3 and will be administered PO/IV maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
16411929|NCT01962636|Drug|Mycophenylate mofetil|Mycophenylate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3.
16411930|NCT01962636|Biological|Umbilical cord blood|Pre-medications and UCB infusion will be per current institutional policies/guidelines. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. If 2 units are used, both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending or designee.
16411931|NCT01928394|Biological|Nivolumab|
16411932|NCT01928394|Biological|Ipilimumab|
16411933|NCT01928394|Drug|Cobimetinib|
16411934|NCT01907360|Drug|HLD200 (methylphenidate hydrochloride)|
16411935|NCT01900574|Drug|Golimumab|Golimumab will be administered subcutaneously. For participants weighing less than 45 kg, the dose of golimumab at Week 0 will be 90 mg/m2 (up to 200 mg) and 45 mg/m2 (up to 100 mg) at Weeks 2, 6, and 10. For participants weighing 45 kg or more, the dose of golimumab at Week 0 will be 200 mg and 100 mg at Weeks 2, 6, and 10. From Week 14, the dose of golimumab will be 45 mg/m2 and 100 mg, every 4 weeks for participants weighing less than 45 kg and 45 kg or more, respectively. From Week 18, participants weighing 45 kg or more have the option to administer golimumab at home after being properly trained. At Week 14 or at any time after, the participants have the option to decrease their dose of golimumab to 50 mg (weighing 45 kg or more) or 22.5 mg/square meter (less than 45 kg) at the discretion of the investigator. A single dose increase back to 100 mg or 45 mg/m2 is permitted based on the investigator's assessment of an increase in a participant's ulcerative colitis disease activity.
16411936|NCT01900132|Device|EIM testing|EIM device is placed on the muscle and a high frequency current is delivered to the skin.
16411937|NCT01900132|Device|Nerve &amp; muscle ultrasonography|Ultrasound waves to examine the muscles and nerves
16411938|NCT01900132|Device|Nerve conduction studies|Small metal disk electrodes attached to wires onto skin to measure how fast nerves conduct electrical impulses and the strength of the connection between nerves and muscles.
16411939|NCT01900132|Device|Electromyography (EMG)|Thin needle placed into muscles to record electrical activity-adults only
16411940|NCT01871727|Drug|E7777 9 mcg/kg|administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days
16412179|NCT00000750|Drug|Zidovudine|
16411941|NCT01839695|Device|Valiant Mona LSA Stent Graft System|All subjects will be implanted with this device
16411942|NCT01835054|Other|Blood biomarkers|Observational Study using Imaging and Biomarkers
16411943|NCT01835054|Genetic|DNA collection|Observational Study using Imaging and Biomarkers
16411944|NCT01835054|Other|Echocardiography|Observational Study using Imaging and Biomarkers
16411945|NCT01835054|Other|Cardiopulmonary exercise testing|Observational Study using Imaging and Biomarkers
16411946|NCT01835054|Other|Magnetic resonance imaging (MRI)|Observational Study using Imaging and Biomarkers
16411947|NCT01835054|Other|Exercise stress doppler echocardiography|Observational Study using Imaging and Biomarkers
16411948|NCT01835054|Other|Holter ECG|Observational Study using Imaging and Biomarkers
16411949|NCT01817751|Drug|sorafenib tosylate|Given by mouth
16411950|NCT01817751|Drug|valproic acid|Given by mouth
16411951|NCT01817751|Drug|sildenafil citrate|Given by mouth
16411952|NCT01794156|Behavioral|Cognitive behavior therapy|
16411953|NCT01794156|Behavioral|Mindfulness-based stress reduction|
16411954|NCT01794156|Behavioral|Inference-based therapy|
16411955|NCT01780662|Drug|Brentuximab Vedotin|Given IV
16411956|NCT01780662|Drug|Gemcitabine Hydrochloride|Given IV
16411957|NCT01757288|Drug|NAB-PACLITAXEL|nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
16411958|NCT01757288|Drug|PACLITAXEL|
16411959|NCT01757288|Drug|NAB-PACLITAXEL|nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
16411960|NCT01752920|Drug|Derazantinib low dose range|Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.
16411961|NCT01752920|Drug|Derazantinib middle dose range|Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.
16411962|NCT01752920|Drug|Derazantinib high dose range|Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.
16411963|NCT01752920|Drug|Derazantinib at recommended phase 2 dose (RP2D)|Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.
16411964|NCT01741272|Procedure|Sling|Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
16411965|NCT01741272|Procedure|No sling|Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
16411966|NCT01534299|Device|Medtronic Renal Denervation System|The Symplicity renal denervation system is comprised of a single-use, disposable catheter and a reusable radiofrequency (RF) generator. The Symplicity renal denervation system has CE Marking for the intended use of delivering low-level radiofrequency energy through the wall of the renal artery to denervate the human kidney.
16411967|NCT01512589|Radiation|Proton Beam Therapy (PBT)|1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
16411968|NCT01512589|Radiation|Intensity Modulated Radiation Therapy (IMRT)|1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
16411969|NCT01512589|Behavioral|Questionnaires|Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.
16411970|NCT01499810|Procedure|Bilateral radiofrequency sympathetic renal denervation|Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways
16411971|NCT01471106|Drug|Dasatinib|"Group 1: 40 mg by mouth once a day.
~Group 2: 80 mg by mouth once a day."
16411972|NCT01451736|Drug|paliperidone palmitate|long-acting injectable
16411973|NCT01451736|Drug|risperidone|oral
16411974|NCT01421186|Drug|MOR03087 phase 1 dose escalation|"Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.
~In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1."
16411975|NCT01421186|Drug|MOR03087|MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.
16411976|NCT01421186|Drug|Dexamethasone|Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.
16411977|NCT01421186|Drug|Pomalidomide|Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
16411978|NCT01421186|Drug|Lenalidomide|Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
16411979|NCT01410890|Biological|alglucosidase alfa|Intravenous (IV) infusion of 20mg/kg body weight every other week (qow)
16411980|NCT01386710|Drug|Bevacizumab and Carboplatin|"Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier
~Day 28: Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until disease progression on MRI scan.
~If progression occurs, repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until progression on MRI scan.
~Repeat Cycle"
16411981|NCT01386710|Drug|Bevacizumab and Carboplatin|"Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier
~Day 28: No biweekly IV Bevacizumab plus Carboplatin treatment
~If MRI shows progression then repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression Repeat Cycle"
16411982|NCT01365169|Behavioral|Exercise Intervention|Participate in walking and/or strengthening program
16411983|NCT01365169|Other|Health Telemonitoring|Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
16411984|NCT01365169|Other|Health Telemonitoring|Use accelerometers, blood pressure monitor, weight scale, and smart phone
16411985|NCT01365169|Other|Health Telemonitoring|Use smart phone
16411986|NCT01365169|Other|Health Telemonitoring|Use CO monitor and smart phone
16411987|NCT01365169|Other|Health Telemonitoring|Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
16411988|NCT01365169|Other|Quality-of-Life Assessment|Ancillary studies
16411989|NCT01365169|Other|Questionnaire Administration|Ancillary studies
16411990|NCT01365169|Other|Health Telemonitoring|Use Fitbit and Actigraph
16411991|NCT01358721|Drug|BMS-936558 (Anti-PD-1)|Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
16411992|NCT01358721|Drug|BMS-936558 (Anti-PD-1)|Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
16411993|NCT01358721|Drug|BMS-936558 (Anti-PD-1)|Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
16411994|NCT01342367|Drug|Bicalutamide|Bicalutamide 50 mg orally daily with either dutasteride or finasteride for 2 months. After two months of treatment bicalutamide with either dutasteride or finasteride will be taken along with radiation. After completion of radiation, bicalutamide will be stopped.
16411995|NCT01342367|Drug|Dutasteride|Dutasteride 0.5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment dutasteride and bicalutamide will be taken along with radiation. After completion of radiation, dutasteride will be taken alone for two years.
16411996|NCT01342367|Drug|Finasteride|Finasteride 5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment finasteride and bicalutamide will be taken along with radiation. After completion of radiation, finasteride will be taken alone for two years.
16411997|NCT01342367|Radiation|Radiation|7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
16411998|NCT01286272|Drug|Bendamustine Hydrochloride|Given IV
16411999|NCT01286272|Drug|Bortezomib|Given IV or SC
16412000|NCT01286272|Radiation|Fludeoxyglucose F-18|Undergo FDG-PET
16412001|NCT01286272|Other|Laboratory Biomarker Analysis|Correlative studies
16412002|NCT01286272|Biological|Ofatumumab|Given IV
16412003|NCT01286272|Procedure|Positron Emission Tomography with Radiolabeled Targeting Agent|Undergo FDG-PET
16412004|NCT01283997|Other|Placebo|One pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
16412005|NCT01283997|Drug|Minocycline|200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.
16412006|NCT01269853|Drug|Bevacizumab|"Experimental portion of this proposal:
~This trial will have two experimental arms that will be open labeled and non-randomized.
~ARM 1 (If the patient has multifocal disease or leptomeningeal disease)
~Day 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until disease progression on MRI scan.
~If progression occurs, repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until progression on MRI scan.
~Repeat Cycle"
16412007|NCT01269853|Drug|Bevacizumab|"ARM 2 (If the patient has no multifocal disease or leptomeningeal disease)
~Day 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: No biweekly IV Bevacizumab treatment
~If MRI shows progression then repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression Repeat Cycle"
16412008|NCT01266096|Drug|PET scan with 124I-cRGDY-PEG-dots|Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.
16412009|NCT01217931|Drug|Pazopanib|800 mg by mouth once daily for 28 days. A cycle consists of 4 weeks.
16412010|NCT01217931|Drug|Bevacizumab|10 mg/kg by vein every two weeks. A cycle consists of 4 weeks.
16412011|NCT01217931|Drug|Everolimus|10 mg by mouth once daily. A cycle consists of 4 weeks.
16412012|NCT01189266|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D conformal radiation therapy
16412013|NCT01189266|Radiation|Intensity-Modulated Radiation Therapy|Undergo intensity-modulated radiation therapy
16412014|NCT01189266|Other|Laboratory Biomarker Analysis|Correlative studies
16412015|NCT01189266|Drug|Vorinostat|Given PO
16412016|NCT01176981|Drug|High Dose Methotrexate|"Methotrexate will be given by IV at a dose of 12 gram/m2/dose.
~The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days)."
16412017|NCT01174108|Device|Miltenyi CD34 Reagent System|The CliniMACS CD34 Reagent System is a medical device that is used in vitro to select and enrich specific cell populations.
16412018|NCT01174108|Other|Donor derived G-CSF mobilized PBC|Cell Therapy
16412019|NCT01138761|Behavioral|Nurse instruction|"The dermatology nurse will give additional verbal and written instruction utilizing teach-back about skin care precautions and medication usage to the caregivers/parents in the treatment group."
16412020|NCT01091961|Procedure|Preoperative ACEi/ARB management|Patients will either hold their chronic ACEi/ARB medication for at least 24 hours prior to surgery, or continue to take the ACEi/ARB medication up to and including the day of surgery
16412021|NCT01035658|Drug|Pazopanib|All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
16412022|NCT01035658|Drug|Doxil|Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle
16412023|NCT00988338|Biological|Trinity Evolution|Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells
16412024|NCT00966979|Device|Triathlon PKR|Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.
16412025|NCT00916383|Drug|350 mg Donepezil Transdermal Patch|Active and placebo patches will be applied to opposite sides for 7 days.
16412026|NCT00916383|Drug|Placebo Patch|Active and placebo patches will be applied to opposite sides for 7 days.
16412027|NCT00900562|Drug|Zalypsis ( PM00104)|Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion
16412028|NCT00801489|Drug|Cytarabine|Given IV
16412029|NCT00801489|Drug|Decitabine|Given IV
16412030|NCT00801489|Biological|Filgrastim-sndz|Given SC
16412031|NCT00801489|Drug|Fludarabine Phosphate|Given IV
16412032|NCT00801489|Drug|Gemtuzumab Ozogamicin|Given IV
16412033|NCT00801489|Drug|Idarubicin|Given IV
16412034|NCT00801489|Other|Laboratory Biomarker Analysis|Correlative studies
16412035|NCT00792948|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic stem cell transplant
16412036|NCT00792948|Drug|Cyclophosphamide|Given IV
16412037|NCT00792948|Drug|Cytarabine|Given IT
16412038|NCT00792948|Drug|Dasatinib|Given PO
16412039|NCT00792948|Drug|Dexamethasone|Given IV or PO
16412040|NCT00792948|Drug|Doxorubicin Hydrochloride|Given IV
16412041|NCT00792948|Drug|Etoposide|Given IV
16412042|NCT00792948|Biological|Filgrastim|Given SC
16412043|NCT00792948|Other|Laboratory Biomarker Analysis|Correlative studies
16412044|NCT00792948|Drug|Leucovorin Calcium|Given IV
16412045|NCT00792948|Drug|Methotrexate|Given IV or IT
16412046|NCT00792948|Drug|Methylprednisolone|Given IV
16412047|NCT00792948|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic stem cell transplant
16412048|NCT00792948|Drug|Prednisone|Given PO
16412049|NCT00792948|Drug|Sirolimus|Given PO
16412050|NCT00792948|Drug|Tacrolimus|Given IV
16412051|NCT00792948|Radiation|Total-Body Irradiation|Undergo TBI
16412052|NCT00792948|Drug|Vincristine Sulfate|Given IV
16412053|NCT00792688|Drug|GLYC-101 Gel (0.1%)|Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
16412054|NCT00792688|Drug|GLYC-101 Gel (1.0%)|Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
16412055|NCT00792688|Drug|GLYC-101 Placebo|Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
16412056|NCT00791635|Other|Quality-of-Life Assessment|Ancillary studies
16412057|NCT00791635|Other|Questionnaire Administration|Complete questionnaires
16412058|NCT00762944|Device|Biomet TMJ Replacement System|Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System
16412061|NCT00713206|Device|Dental Implant (Osseotite)|Root form titanium dental implant
16412062|NCT00656474|Drug|Placebo gel|Administration of Placebo gel on Day 1, 3 and 5 post ablation.
16412063|NCT00656474|Drug|GLYC-101 gel (1.0 %)|Administration on Day 1, 3 and 5 post laser ablation.
16412064|NCT00648635|Behavioral|Questionnaire|Questionnaires taking 30-60 minutes to complete every 3 months.
16412065|NCT00606346|Biological|Anti TNF therapy including infliximab|Treatments will be prescribed according to investigator judgement.
16412066|NCT00606346|Drug|No Biologics|Treatments will be prescribed according to investigator judgement.
16412067|NCT00507572|Other|Medical Chart Review|Medical records are reviewed
16412068|NCT00436254|Biological|pNGVL3-hICD vaccine|Plasmid-based DNA vaccine, given intradermally
16412069|NCT00436254|Biological|sargramostim|Given intradermally
16412070|NCT00436254|Other|flow cytometry|Correlative studies
16412071|NCT00436254|Other|immunologic technique|Correlative studies
16412072|NCT00436254|Other|immunoenzyme technique|Undergo ELIspot (correlative studies)
16412073|NCT00436254|Genetic|protein expression analysis|Undergo ELISA (correlative studies)
16412074|NCT00436254|Procedure|biopsy|Undergo punch biopsy (correlative studies)
16412075|NCT00412360|Biological|Single Umbilical Cord Blood Unit Transplant|Unrelated donor, single umbilical cord blood unit; conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
16412076|NCT00412360|Biological|Double Umbilical Cord Blood Unit Transplant|Unrelated donor, double umbilical cord blood unit; Conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
16412077|NCT00412360|Radiation|Total Body Irradiation|The TBI will be delivered from either a linear accelerator or cobalt source at a dose rate of between 4 and 26 cGy/minute using energies of between 1 and 25 MV.
16412078|NCT00412360|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush on Days -3 and -2.
16412079|NCT00412360|Drug|Fludarabine|Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -10 through -8. Fludarabine will not be dose adjusted for body weight.
16412080|NCT00412360|Drug|Cyclosporine A|CSA will be administered beginning on Day -3 and doses will be adjusted to maintain a level of 200-400 ng/mL by TDX method (or 100-250 ng/mL by Tandem MS or equivalent level for other CSA testing methods). CSA can be administered per institutional practice.
16412081|NCT00412360|Drug|Mycophenolate Mofetil|MMF will be given at a dose of 1 gram IV q 8 hours if > 50 kg or 15 mg/kg IV q 8 hours if < 50 kg beginning the morning of Day -3.
16412082|NCT00390793|Drug|Cyclophosphamide|Given IV
16412083|NCT00390793|Drug|Cytarabine|Given IV or IT
16412084|NCT00390793|Drug|Dasatinib|Given PO
16412085|NCT00390793|Drug|Dexamethasone|Given IV or PO
16412086|NCT00390793|Drug|Doxorubicin|Given IV
16412087|NCT00390793|Drug|Methotrexate|Given IV or IT
16412088|NCT00390793|Drug|Prednisone|Given PO
16412089|NCT00390793|Drug|Vincristine|Given IV
16412090|NCT00326417|Drug|Fludarabine|Doses of 30 mg/m^2 IV will be given for no less than 30 minutes daily for 4 days (Days -5 to -2)
16412091|NCT00326417|Drug|Cyclophosphamide 150mg|A total dose of 150 mg/kg will be given as 50 mg/kg per day for 3 days (Days -4, -3, -2)
16412180|NCT00000743|Drug|Alvircept sudotox|
16412092|NCT00326417|Drug|Cyclophosphamide 100mg|A total dose of 100 mg/kg will be given as 50 mg/kg per day for 2 days (Days -3, -2)
16412093|NCT00326417|Drug|Cyclophosphamide 50mg|A total dose of 50 mg/kg will be given once at 50 mg/kg per day on Day -2
16412094|NCT00297596|Drug|Trastuzumab|Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
16412095|NCT00297596|Drug|Oxaliplatin|"Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.
~For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab"
16412096|NCT00210119|Drug|Glivec|
16412097|NCT00189540|Genetic|HGF plasmid|Intramuscular injections into the index leg on days 0, 14, and 28
16412098|NCT00189540|Genetic|Placebo|Intramuscular injections into the index leg on days 0, 14, and 28
16412099|NCT00114101|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSCT
16412100|NCT00114101|Other|Laboratory Biomarker Analysis|Correlative studies
16412101|NCT00114101|Drug|Lenalidomide|Given PO
16412102|NCT00114101|Drug|Melphalan|Given IV
16412103|NCT00114101|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSCT
16412104|NCT00114101|Other|Placebo Administration|Given PO
16412105|NCT00017953|Behavioral|Lifestyle Intervention|The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.
16412106|NCT00017953|Behavioral|Diabetes Support and Education|Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
16412107|NCT00000901|Drug|Indinavir sulfate|
16412108|NCT00000901|Drug|Lamivudine|
16412109|NCT00000901|Drug|Stavudine|
16412110|NCT00000885|Drug|Indinavir sulfate|
16412111|NCT00000885|Drug|Abacavir sulfate|
16412112|NCT00000885|Drug|Nelfinavir mesylate|
16412113|NCT00000885|Drug|Efavirenz|
16412114|NCT00000885|Drug|Levocarnitine|
16412115|NCT00000885|Drug|Adefovir dipivoxil|
16412116|NCT00000885|Drug|Lamivudine|
16412117|NCT00000885|Drug|Stavudine|
16412118|NCT00000885|Drug|Zidovudine|
16412119|NCT00000885|Drug|Didanosine|
16412120|NCT00000880|Drug|Cyclosporine|
16412121|NCT00000869|Drug|Nevirapine|
16412122|NCT00000868|Biological|Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203)|
16412123|NCT00000868|Biological|Aluminum hydroxide|
16412124|NCT00000868|Biological|MF59|
16412125|NCT00000868|Biological|rgp120/HIV-1MN|
16412126|NCT00000866|Biological|MN rgp120/HIV-1|
16412127|NCT00000866|Biological|TBC-3B Vaccine|
16412128|NCT00000865|Drug|Abacavir sulfate|
16412129|NCT00000865|Drug|Lamivudine|
16412130|NCT00000865|Drug|Stavudine|
16412131|NCT00000865|Drug|Zidovudine|
16412132|NCT00000865|Drug|Didanosine|
16412133|NCT00000864|Drug|Abacavir sulfate|
16412134|NCT00000864|Drug|Zidovudine|
16412135|NCT00000863|Drug|Sitamaquine|
16412136|NCT00000862|Drug|Zidovudine|
16412137|NCT00000861|Drug|Indinavir sulfate|
16412138|NCT00000855|Drug|Zidovudine|
16412139|NCT00000833|Drug|Ribavirin|
16412140|NCT00000833|Drug|Didanosine|
16412141|NCT00000829|Biological|Pneumococcal Vaccine, Polyvalent (23-valent)|Administered as an injection at 24 months of age
16412142|NCT00000829|Biological|Pneumococcal Conjugate Vaccine, Heptavalent|Administered as an injection at 0, 2, 4, and 15 months of age
16412143|NCT00000829|Biological|Placebo|Administered at 0, 2, 4, and 15 months of age
16412144|NCT00000823|Drug|Zidovudine|
16412145|NCT00000823|Drug|Didanosine|
16412146|NCT00000820|Drug|Aldesleukin|
16412147|NCT00000815|Biological|Attenuvax|Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
16412148|NCT00000815|Biological|M-M-R-II|Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
16412149|NCT00000814|Drug|Nevirapine|
16412150|NCT00000814|Drug|Zidovudine|
16412151|NCT00000814|Drug|Didanosine|
16412152|NCT00000812|Drug|Thalidomide|
16412153|NCT00000807|Drug|Etoposide|
16412154|NCT00000794|Drug|Sulfadiazine|
16412155|NCT00000794|Drug|Clarithromycin|
16412156|NCT00000794|Drug|Atovaquone|
16412157|NCT00000794|Drug|Pyrimethamine|
16412158|NCT00000794|Drug|Leucovorin calcium|
16412159|NCT00000791|Drug|Glycovir|
16412160|NCT00000791|Drug|Zidovudine|
16412161|NCT00000777|Biological|gp160 Vaccine (MicroGeneSys)|
16412162|NCT00000776|Drug|Flucytosine|
16412163|NCT00000776|Drug|Fluconazole|
16412164|NCT00000776|Drug|Amphotericin B|
16412165|NCT00000776|Drug|Dexamethasone|
16412166|NCT00000773|Drug|Atovaquone|
16412167|NCT00000772|Drug|Ribavirin|
16412168|NCT00000772|Drug|Didanosine|
16412169|NCT00000769|Drug|Interleukin-4|
16412170|NCT00000767|Biological|TBC-3B Vaccine|
16412171|NCT00000767|Biological|Smallpox Vaccine|
16412172|NCT00000765|Drug|Zidovudine|
16412173|NCT00000764|Drug|Isotretinoin|
16412174|NCT00000764|Drug|Interferon alfa-2a|
16412175|NCT00000752|Drug|Pseudoephedrine hydrochloride|
16412176|NCT00000752|Drug|Guaifenesin|
16412177|NCT00000752|Drug|Cefuroxime axetil|
16412178|NCT00000752|Drug|Beclomethasone dipropionate|
16412189|NCT05101031|Device|Starling SV|The Starling SV will monitor the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial fluid resuscitation in individuals with hypotension related to infection.
16412190|NCT05101018|Drug|Romosozumab|Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month
16412191|NCT05101018|Drug|Denosumab|Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months
16412192|NCT05101005|Device|Drug-Coated Balloon|Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.
16412193|NCT05101005|Device|Sirolimus-Eluting Stent|Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.
16412194|NCT05100992|Procedure|Percutaneous Coronary Interbention|Percutaneous Coronary Interbention
16412195|NCT05100979|Other|The Art of Medicine Series|The Art of Medicine Series is a smartphone-based educational tool focused on teaching communication strategies to clinicians and patients.
16412196|NCT05100966|Other|FitJoints Multi-modal Intervention|"Exercise: The study physiotherapist will prescribe an exercise program tailored to the participant's individual ability and preference with functional movements to mimic activities of daily living.
~Nutritional consultation and protein supplement: The site research assistant will coach participants to improve their nutrition, determine their daily protein target, and provide educational tools on how to achieve their target. Protein supplements will be provided to participants.
~Vitamin D: Participants will be provided with vitamin D3 (1000 IU) tablets to reduce the risk of falls and to preserve muscle strength and functional ability. They will be instructed to take one tablet daily for the duration of the intervention period.
~Medication optimization: The study pharmacist will conduct a medication review and provide, if required, recommendations for medication optimization."
16412197|NCT05100953|Behavioral|Physical Activity Counseling|Physical activity counseling will be provided under supervision by the researcher physiotherapist via video conference and an individual physical activity program will be organized weekly for two months.
16412198|NCT05100940|Procedure|Cardiac Catheterization|Cardiac Catheterization
16412199|NCT05100914|Other|Couple-based family nursing|Spouses were taught the following rehabilitation movements: hand squeeze, wrist, and elbow flexion and extension, pendulum exercise, finger wall-climbing exercise, hair combing, wall pushup, pulley exercise, and turning around exercise. Arm rehabilitation begins within 48 hours postoperatively, and each movement should be incrementally increased in terms of exertion and repetition until the patient reaches 10 repetitions, 2-3 times daily, for one month. Spouses must support patients' wrist and elbow joints and maintain the arms perpendicular to the body. Spouses were instructed that if women experience negative emotions during the rehabilitation movements, spouses can express support to his wife through body language, such as kissing, holding hands, touching, or hugging.
16412200|NCT05100901|Dietary Supplement|MAG oil oral nutritional supplement (ONS)|The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals.
16412201|NCT05100888|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|Theta-burst stimulation
16412202|NCT05100875|Behavioral|"Social Skills and Emotion Regulation Training SSERT"|The SSERT intervention will broadly consist of the following 10 modules: (1) Introducing the Participant to Treatment; (2-3) Emotional Awareness and Recognition; (4-5) Emotion Regulation and Understanding Emotions in the Context of Psychotic Experiences; (6) Living an Emotionally Engaged Life; (7) Understanding Relationship Patterns in the Context of Psychosis; (8) Changing Undesirable Relationship Patterns; (9) Learning to have agency in Relationships; and (10) Flexibility in Relationships and Transitioning to Trauma-Focused Therapy.
16412203|NCT05100862|Drug|Zanubrutinib|Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) continuously in repeated 28-day cycles.
16412204|NCT05100862|Drug|Rituximab|Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
16412205|NCT05100862|Drug|Lenalidomide|Lenalidomide will be administered orally as 20-mg capsules once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
16412206|NCT05100849|Procedure|Kinect-based cognitive training|The Kinect-based group will be involved in the standard treatment protocol and will perform a 14-sessions cognitive training program that consists of instrumental activities of daily living simulations. The cognitive training content will be projected onto a wall and patients will interact with the content, i.e., the selection of the appropriate response, through movement (kinect).
16412207|NCT05100849|Procedure|Tablet-based cognitive training|The Tablet-based group will be involved in the standard treatment protocol and will perform a 14-sessions cognitive training program that consists of instrumental activities of daily living simulations. Patients will interact with the cognitive training content through a tablet.
16412208|NCT05100836|Device|Impella 5.5|Impella 5.5 mechanical circulatory support
16412209|NCT05100823|Procedure|Nasal cells sampling|Nasal epithelium brushing in intermediate turbinate using a specific curette following a local anesthesia with Xylocaine 5% nebulizer.
16412210|NCT05100823|Procedure|Rectal biopsy sampling|Forceps Biopsy Procedure (Servidoni et al., 2013) Only for volunteer patients included in the Montpellier center.
16412211|NCT05100810|Other|Natural History Study|Longitudinal assessment of disease progression of Angelman syndrome in patients
16412212|NCT05100797|Device|Vyntus CPX|To study the validity, precision and accuracy of the Vyntus CPX metabolic cart using both, in-vitro and in-vivo (i.e., human study) measures.
16412213|NCT05100784|Biological|HSSA test|Human Sperm Survival Assay testing performed on different batches of different types of IVF consumables. In practice, 3 consumables from the same batch will be tested with 3 different sperms to ensure the repeatability of the result / test.
16412214|NCT05100771|Other|Pediatric brain MRI|Routine brain MRI with automated quantitative information (brain volumetry and T1 relaxometry)
16412215|NCT05100758|Dietary Supplement|Active Hexoses Correlated Compound|Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.
16412216|NCT05100745|Device|Therapeutic Device|This device delivers ultrasound energy to the targeted area of the lower limb.
16412217|NCT05100719|Drug|alverine-citrate + simethicone and lactase|Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
16412507|NCT05070585|Dietary Supplement|Placebo Juice|Sprout juice devoid of isothiocyanates for 1 week
16412218|NCT05100719|Drug|alverin-citrate + simethicone with placebo|Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
16412219|NCT05100706|Drug|Continuous adductor canal block (CACB)|Ropivacaine 0.2% infusion through adductor canal catheter
16412220|NCT05100706|Drug|Sham continuous adductor canal block (ShACB).|NaCl 0.9% infusion through adductor canal catheter
16412221|NCT05100693|Other|Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon|Fetal Endoscopic Tracheal Occlusion using the Smart-TO balloon and non-invasive balloon removal by the peripheral magnetic field of an magnetic resonance scanner.
16412222|NCT05100680|Other|Multicomp|Daily dietary supplementation over 12 weeks with test product: food supplement - 2 capsules / day containing together: 20 mg coenzyme Q10,500 mg methyl sulfonyl methane (MSM), 100 mg L-proline, 10 mg L-cysteine (as HCl monohydrate), 2 mg thiamine , 2.4 mg riboflavin, 19 mg niacin, 8.5 mg pantothenic acid, 2.3 mg vitamin B6, 0.15 mg, biotin, 0.0125 mg vitamin B12, 80 mg vitamin C, 5.5 mg vitamin A , 22 mg vitamin E, 10 mg zinc, 0.07 mg selenium, 1.1 mg copper.
16412223|NCT05100680|Other|Placebo|Daily dietary supplementation over 12 weeks with placebo product: dietary supplement - 2 capsules / day, containing only modified starch.
16412224|NCT05100667|Other|Hypoxia|altitude (3800m)
16412225|NCT05100667|Other|Normoxia|sea level
16412226|NCT05100654|Drug|Doxycycline|Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
16412227|NCT05100654|Drug|Ciprofloxacin|Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
16412228|NCT05100654|Drug|Augmentin|Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
16412229|NCT05100654|Drug|Bactrim|Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
16412230|NCT05100641|Biological|AV-GBM-1|Therapeutic autologous dendritic cell vaccine
16412231|NCT05100641|Biological|Autologous monocytes|Autologous monocyte control
16412232|NCT05100628|Drug|NOX66|"NOX66 800 mg (400 mg suppository twice daily [BID]).
~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."
16412233|NCT05100628|Drug|NOX66|"NOX66 1200 mg daily (600 mg suppository BID).
~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."
16412234|NCT05100628|Drug|NOX66|"NOX66 1800 mg daily (600 mg suppository thrice daily).
~Monotherapy: 7 days of NOX66 followed by 5 days washout. Combination therapy: 7 days of NOX66 followed by 14 days washout in a 21-day cycle, for up to 6 cycles."
16412235|NCT05100628|Drug|NOX66|MTD of the combination of NOX66 and doxorubicin will be determined in the dose-escalation cohort of the study. The selected dose will be administered in combination with Doxorubicin.
16412236|NCT05100628|Drug|Doxorubicin|Doxorubicin will be given at 75 mg/m^2 as an intravenous infusion on Day 2 of the 21-day cycle for up to 6 cycles.
16412237|NCT05100615|Procedure|surgery|applying the graft inside bony defect after surgery
16412238|NCT05100589|Dietary Supplement|PeakATP|Powder - 400mg Peak ATP, maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum
16412239|NCT05100589|Dietary Supplement|Placebo|Powder - maltodextrin, silica-colloidal anhydrous, citric acid anhydrous, sucralose, guar gum
16412240|NCT05100576|Device|Telemedicine system users|Telemonitoring by medical devices connected to a software system with a router.
16412241|NCT05100563|Drug|50 mg naltrexone|Medication combined with twice a week psychotherapy
16412242|NCT05100550|Dietary Supplement|Zinc|Zinc is given as written in the arm description, two hours after lunch
16412243|NCT05100550|Other|Control|This group will not receive zinc
16412244|NCT05100537|Behavioral|Mindfulness Based Stress Reduction|The intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of emotions, awareness of thoughts, awareness of sensations. It involves full awareness of daily activities, using the breath as an anchor for attention.In addition to mindfulness practices and experiential work, psychoeducation and participants' sharing will clarify the issues of stress, stress management and how mindfulness is applied in daily situations and interpersonal communication.
16412245|NCT05100537|Other|continuing a routine life|No intervention will be made in the control group.
16412246|NCT05100524|Other|Motivational interview|The motivational interviewing technique is a client-focused, directive form of counseling to create behavior change. Its main goal is to discover and solve ambivalence. This method is especially useful for people who are reluctant or ambivalent to change.
16412247|NCT05100524|Other|Ongoing treatment|Patients with total knee replacement receive standard nurse care. Treatment is applied. He does his own exercises at home.
16412248|NCT05100511|Device|ERG electrode tests for fundus image-guided focal ERG|Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.
16412249|NCT05100511|Device|Fundus image-guided focal ERG|Record focal ERG from a healthy retinal area and from an area with visible symptoms.
16412250|NCT05100498|Device|Web-based oncofertility support tool|The website structure was developed to satisfy the needs of reproductive-age women was investigated based on four domains of social support, as developed by Cohen and Syme (1985). The important needs of patients can be classified as emotional, informational, appraisal, and instrumental support.
16412251|NCT05100485|Diagnostic Test|Esophagogasrtoduodendoscopy|Esophagogasrtoduodendoscopy was used to detech the presence of varices.
16412252|NCT05100485|Diagnostic Test|Hepatic venous pressure gradient|A method used to eveluate the portal pressure
16412253|NCT05100472|Biological|Androgen deprivation therapy (ADT)|ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.
16412254|NCT05100472|Radiation|Brachytherapy|After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.
16412508|NCT05067972|Drug|PF-07260437|B7-H4 x CD3 bi-specific mAb
16412255|NCT05100472|Radiation|Hypofractionated pelvic External beam radiation|Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
16412256|NCT05100459|Dietary Supplement|Pasture-raised whey protein|25 grams of protein delivered 3 times daily
16412257|NCT05100459|Dietary Supplement|Conventional whey protein|25 grams of protein delivered 3 times daily
16412258|NCT05100459|Dietary Supplement|Placebo|Iso-caloric placebo taken 3 times daily like the protein supplementation
16412259|NCT05100446|Drug|Amoxicillin - high dose dual therapy|Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.
16412260|NCT05100446|Drug|Pylera|Eradication with Pylera, for 10 days.
16412261|NCT05100446|Drug|Esomeprazole 40mg|Esomeprazole 40mg, twice a day.
16412262|NCT05100433|Procedure|Ultrasonic irrigation|Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.
16412263|NCT05100394|Radiation|Laser Therapy|Therapeutic laser therapy was applied.
16412264|NCT05100394|Other|Ultrasound + Moist Heat pack + Exercises|Ultrasound therapy, a moist heat pack, and a home exercise program were given.
16412265|NCT05100381|Other|dry needling|The method of performing the dry needling technique will be based on the methods presented by Dommerholt and Fernandez-de-Las-Penas. In this method, the patients will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. Two lengths of sterile, disposable, 0.30 mm x 75 mm and 0.30 mm x 50 mm solid filament needle (Tony, China) will be used in this study. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted into the lumbar multifidus muscle, 1.5 - 2 cm lateral to the spinous process of two or three painful segments, perpendicular to lamina (after piercing the skin, needles are directed inferomedially). The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes.
16412266|NCT05100381|Other|sham (placebo) dry needling|The sham dry needling method includes the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes.
16412267|NCT05100368|Other|patients|Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis
16412268|NCT05100355|Procedure|Physiological serum injection|In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray
16412269|NCT05100355|Procedure|Contrast agent injection|In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray
16412270|NCT05100342|Diagnostic Test|Point score prediction tool for 30-day survival|"This tool requires laboratory data including white blood cell count, neutrophil-lymphocyte ratio, blood urea nitrogen, bilirubin, albumin, lactate dehydrogenase, and red cell distribution, as well as number of attendances to the emergency room in the past 100 days, the site receiving radiation therapy, and the primary cancer type. Each data point correlates with a point value, which are tallied to generate a final score.
~The scores range from 0-20, with 0 giving the highest chance for survival at 30 days and 20 giving the lowest chance for survival at 30 days"
16412271|NCT05100329|Drug|Mitoxantrone Hydrochloride Liposome injection|20 mg/m^2, IV, on day 1 of every 3 weeks (q3w, a cycle)
16412272|NCT05100316|Other|Screening Platform|Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.
16412273|NCT05100303|Drug|Mitoxantrone Hydrochloride liposome injection|Mitoxantrone hydrochloride liposome will be administered by intravenous (IV) injections.
16412274|NCT05100303|Drug|Cytarabine (LoDAC)|Low-dose or high-dose cytarabine (LoDAC) will be administered by intravenous (IV) injections.
16412275|NCT05100290|Diagnostic Test|Hyperventilation Provocation Test (HPTest)|"During the HPTest, the subject is comfortably seated in a chair with armrests and breathes in a mouthpiece with a salivary collector and a nasal clamp. Parameters of ventilation and gas exchange are analyzed via an Oxycon ProTM (SN808008) with TripleV-Volume Sensor digital(Jaeger).
~The HPTest begins with a 3-minutes adaptation phase during which the patient is asked to breathe normally. During the 3-minutes of voluntary hyperventilation phase, the patient is asked to increase his tidal volume and support a breath rate of at least 30/min in order to reduce his PETCO2 by at least 50%. During the recovery phase of the HPTest, the patient is invited to regain a natural breathing for 5 minutes, without guidance on tidal volume or breath rate."
16412276|NCT05100277|Genetic|Oncotype DX® Assay|After surgery, tumoral tissue was used to perform Oncotype Dx®. Patients were evaluated and therapy recommendations - adjuvant chemotherapy (CT) plus hormone therapy (HT) or HT alone - were captured before and after revealing the test results. Results from TAILORx10 were used to guide decisions for or against CT for individual patients. Changes in treatment recommendations were obtained.
16412277|NCT05100277|Other|Cost|Changes in treatment costs were estimated from Pérola Byington Hospital.
16412278|NCT05100264|Other|Vaginal washing with 5% acetic acid|Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
16412279|NCT05100264|Other|Vaginal washing with 0.9% NS|Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)
16412280|NCT05100251|Drug|WBC100|"The first stage: single dose escalation according to classic 3+3 dose escalation method. 6 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QD. The second dose group is 1mg QD. The third dose group is 1.5 mg QD. The fourth dose group is 2.0 mg QD. The fifth dose group is 2.5 mg QD. The sixth dose group is 3.0 mg QD. In each dose group, patients take WBC100 once on cycle 0. After a washout period of 2 days, patents start subsequent 4 weeks cycles until progression disease or intolerable toxicity. In each cycle, patient was on WBC100 every for 3 weeks and off for 1 week.
~The second stage: Two dose levels will be chosen according to data from the first stage. Each dose stage enroll 12 pancreatic patients with positive c-myc expression."
16412281|NCT05100225|Biological|PTP-001|Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
16412282|NCT05100225|Other|Placebo control|The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
16412509|NCT05067972|Diagnostic Test|B7-H4 IHC|B7-H4 expression
16412283|NCT05100212|Biological|cord blood-RBC concentrates|Patients in the experimental arm are candidates to receive CB-RBC units until the completion of 31 weeks of postmenstrual age (31+6). In case of unavailability of an ABO/Rh matched CB-RBC unit, patients receive adult -RBC (standard transfusions).
16412284|NCT05100212|Biological|adult donor RBC concentrates|Patients in the comparator arm are candidates to receive adult donor-RBC units
16412285|NCT05100199|Drug|OnabotulinumtoxinA X|Injection
16412286|NCT05100199|Drug|Placebo|Injection
16412287|NCT05100186|Drug|Dexamethasone 0.4 MG [Dextenza]|Dextenza
16412288|NCT05100160|Drug|Gabapentin|Given by PO
16412289|NCT05100160|Other|Placebo|Given by PO
16412290|NCT05100147|Procedure|Uterine closure during Cesarean section|The uterotomy is sutured after the delivery of the fetus and the placenta with an appropriate delayed absorbable suture (number 1 polyglactin 910)
16412291|NCT05100134|Drug|ceritinib|LDK378 will be administered orally once daily at a dose of 750 mg (fasting) or 450 mg (with food) on a continuous dosing schedule.
16412292|NCT05100121|Device|Interactive app|In the app, the patients will report frequency and distress on commons concerns regarding urine dysfunction, bowel dysfunction, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual dysfunction. Free text comments will also be possible to make to cover the patients' other potential needs. Questions regarding symptoms of acute character that might need to be treated quickly like severe pain, blood in stool and urine, and involuntary weight loss will also be asked for to timely detect and treat signs of for example cancer relapse. Information about the concerns will be included in the app containing; a) general information of why they have the side effect and what it means b) evidence-based advice about self-management; c) when they should contact health care providers, and d) further information linked to reliable documents and web pages.
16412293|NCT05100121|Other|Survivor-ship care|At coaching session with the district nurse, patient reported assessments will be used to discuss the individual's current situation and to plan eventual additional actions needed such as support from a physiotherapist, social worker, dietitian or if a visit to the physician if needed. This is documented in a survivorship care plan which contain e.g., risk of symptoms, late effects, healthy lifestyle information, prevention tips and support of psychosocial concerns. The intervention incorporates coaching encounters using motivational interviewing techniques to engage patients in the patient-owned survivor-ship care plan that include health goals and strategies related to cancer follow-up, surveillance, symptom management, and health behavior.
16412294|NCT05100108|Behavioral|Dog-assisted therapy|The program will involve 8 sessions, conducted once a week for 8 weeks. Each session will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to relaxation and say goodbye to the dogs.
16412295|NCT05100095|Drug|Radiation therapy|Hypofractionated radiation therapy to the primary tumor and/or lymph nodes
16412296|NCT05100082|Drug|Cabozantinib|Cabozantinib tablets
16412297|NCT05100069|Drug|Brigatinib|Brigatinib Tablets
16412298|NCT05100056|Other|No Intervention|This is a non-interventional study.
16412299|NCT05100043|Biological|IL-4 and IFN-γ measurements|Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants
16412300|NCT05100017|Drug|Methocarbamol|Patients will receive oral Methocarbamol 750mg every six hours as needed for pain post ureteroscopy in addition to the standard postoperative pain regimen.
16412301|NCT05100017|Drug|Oxybutynin|Patients will receive oral Oxybutynin XL 10mg daily for pain post ureteroscopy in addition to the standard postoperative pain regimen.
16412302|NCT05100004|Device|Accelerated Theta Burst Stimulation|"Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Magventure Magpro X100 TMS system."
16412303|NCT05100004|Device|Sham Stimulation|"Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.
~Sham stimulation will be delivered using the Magventure Magpro X100 TMS system."
16412304|NCT05099991|Device|Single Foley Balloon|Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure
16412305|NCT05099991|Device|Dilapan-S|Dilapan S will be placed through the cervix on the day prior to the procedure
16412306|NCT05099978|Genetic|NGS analysis of ctDNA|Diagnostic Test: plasma circulating tumor DNA
16412307|NCT05099965|Biological|CMV-MVA Triplex|5 x 108 plaque-forming unit (pfu) ±0.5 x 108 pfu of MVA Vaccine
16412308|NCT05099965|Biological|Placebo|7.5% Lactose in phosphate-buffered saline [PBS]
16412309|NCT05099952|Procedure|Biospecimen Collection|Undergo collection of cheek cell and blood samples
16412310|NCT05099952|Other|Counseling|Meet with therapist
16412311|NCT05099952|Other|Educational Intervention|Participate in BBT-CI sessions
16412312|NCT05099952|Other|Electronic Health Record Review|Medical records are reviewed
16412313|NCT05099952|Other|Medical Device Usage and Evaluation|Wear actigraphy watch
16412314|NCT05099952|Other|Questionnaire Administration|Ancillary studies
16412315|NCT05099926|Behavioral|Reducing Exercise Sensitivity with Exposure Training|"Participants complete 4, home-based intervention visits on a secure video visit platform. Video visits include psychoeducation, interoceptive exposure, and interoceptive counseling. For homework, participants are asked to document their weekly physical activity and exercise sensations in a journal.
~Psychoeducation: Participants are educated about the benefits and safety of exercise and cardiac rehabilitation, the role of fear and anxiety in exercise avoidance, and the concept of interoceptive exposure.
~Interoceptive Exposure: A gradual six-minute walk (G6MW) serves as a low-risk form of interoceptive exposure. Exercise sensations and ratings of perceived intensity and distress are collected before and after the G6MW.
~Interoceptive Counseling: Participants review and reflect upon their pre-walking and post-walking physical sensations and ratings (intensity and distress) with a research team member. Homework is also reviewed."
16412316|NCT05099913|Drug|Deanxit|Central neuromodulators was applied in refractory FD patients for different time
16412317|NCT05099887|Biological|Procenta conformable barrier|Wound care dressing biologic allograft
16412318|NCT05099874|Device|EndeavorRx|EndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level.
16412319|NCT05099861|Other|No intervention|this is an observational study
16412320|NCT05099848|Drug|Camrelizumab|"Procedure:
~Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication.
~On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks.
~On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times.
~The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear."
16412321|NCT05099835|Drug|Botox|injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)
16412322|NCT05099835|Drug|triamcinolonacetonide|triamcinolonacetonide stellate ganglion injection
16412323|NCT05099822|Drug|CC-97489|Specified dose on specified days
16412324|NCT05099822|Other|Placebo|Specified dose on specified days
16412325|NCT05099809|Other|Hyperthermia|Hyperthermia would be delivered once/twice a week for 60 to 90 minutes depending on patient's tolerance. A shortwave diathermy unit operating at 27.1 MHz would be used to deliver locoregional hyperthermia.
16412326|NCT05099796|Procedure|Transforaminal epidural steroid injection|
16412327|NCT05099796|Procedure|Caudal epidural steroid injection|
16412328|NCT05099783|Diagnostic Test|late gadolinium enhanced magnetic resonance imaging|Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and MRI were performed after cardioversion at least twice.
16412329|NCT05099770|Biological|Renal Autologous Cell Therapy|Participants will receive either 2 REACT injections or 2 Sham REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart.
16412330|NCT05099757|Biological|20 µg dose hepatitis B vaccine|one-dose, two-dose or three-dose, 20 µg per dose
16412331|NCT05099744|Behavioral|Electrostimulation Therapy|During 20 minutes participants are connected to the handles and receive electrostimulation therapy.
16412332|NCT05099744|Behavioral|Relaxation|During 20 minutes participants receive a session of relaxation with guided imagination. These sessions will be implemented by a trained therapist who will follow a script. The relaxation sessions are based on Schultz's autogenic relaxation training, a relaxation technique based on autosuggestion.
16412333|NCT05099744|Behavioral|Placebo|During 20 minutes participants will be connected to the handles but will not receive any frequency.
16412334|NCT05099718|Procedure|palatal soft tissue harvesting|A 6x2mm palatal soft tissue graft will be harvested.
16412335|NCT05099718|Device|Hyaluronic acid|application 3-times per day for 7 days
16412336|NCT05099718|Other|Saline solution (placebo)|application 3-times per day for 7 days
16412337|NCT05099705|Behavioral|Access to a Family Service Navigator and Treatment Support System|An RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system.
16412338|NCT05099692|Behavioral|filling out the questionnaire|all participants in our study are invited to choose at least 5 questions in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information
16412339|NCT05099679|Behavioral|Cognitive behavioral therapy (supportive counseling)|Providing patients with a 2-hour psychosocial counseling intake (and if appropriate as assessed by clinical social worker, up to 10 subsequent counseling sessions).
16412340|NCT05099679|Behavioral|Virtual Cardiac Rehabilitation|If eligible, patients will be referred to Moving Analytics Virtual Cardiac Rehabilitation to provide approximately 3 exercise sessions per week, with approximately eight coaching sessions over a 12 week period
16412341|NCT05099666|Drug|Lurbinectedin|Dosage per protocol, escalation per protocol, IV over 60 minutes (± 5 minute infusion window), schedule per protocol
16412342|NCT05099666|Drug|Doxorubicin|Dosage per protocol, IV per institutional standards of practice and the FDA package insert, schedule per protocol
16412343|NCT05099653|Other|physical activity|physical activity
16412344|NCT05099640|Drug|PTC923|PTC923 powder for oral use will be suspended in water or apple juice prior to administration.
16412345|NCT05099640|Drug|Placebo|Placebo matching to PTC923
16412346|NCT05099627|Other|"The questionnaire Cervical myelopathy treatment outcome questionnaire"|"Information gathered through clinical examination and questionnaires performed retrospectively over the phone, pre-operation and at 3- and 6-months post-operation. The questionnaire Cervical myelopathy treatment outcome questionnaire attached records information relating to co-morbidities and symptomology. The examination will be a thorough neurological examination in addition to a focused cardiovascular examination. Biochemical blood markers from existing blood markers or from GP records, which have been or would have been performed regardless of this trial. Radiological findings will be taken from routine MRI and cervical spine X-rays performed as part of the CSM diagnostic work-up"
16412347|NCT05099627|Other|"The retrospective questionnaire CSM early diagnosis questionnaire"|To identify early clinical predictors of cervical myelopathy diagnosis based on individual patient-reported symptoms by using a questionnaire and patient characteristics as well as co-morbities, as well as clinical examination findings provided by community musculoskeletal teams.
16412348|NCT05099627|Other|JOACMEQ questionnaire and mJOA|Used for prospective cohort via telephone at 3, 6 and 12-months post-operatively to assess treatment outcomes.
16412349|NCT05099614|Combination Product|Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system|1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.
16412350|NCT05099601|Combination Product|Silymarin|The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
16412351|NCT05099601|Procedure|Microneedling|Patients will be subjected to microneedling sessions on one side of the face. Three consecutive sessions, 4 weeks apart (0, 4, 8 weeks), will be performed by dermapen. Sessions will be done by well trained physician.
16412352|NCT05099588|Other|Other: observational study|Observational study
16412353|NCT05099575|Drug|Syntocinon, papal, misotac|Using different drugs to prevent atonic PPH during CD in high risk group
16412354|NCT05099562|Drug|Acupuncture|Patients received standardized acupuncture treatment. A blood sample of genomic DNA storage was taken from the back of the hand between the first and second metacarpals. Genotypes were obtained by oligonucleotide ligation/polymerase chain reaction and capillary electrophoresis of peripheral neuropathy-associated SNPs.
16412355|NCT05099549|Drug|AFM24|Tetravalent, bispecific EGFR- and CD16A-binding innate cell engager.
16412356|NCT05099549|Biological|SNK01|Patient-specific ex-vivo expanded autologous natural killer cells.
16412357|NCT05099536|Drug|3D011-08|participants will receive 15mg (starting dose)intravenous drop of 3D011-08,All subjects in each cohort will receive a single dose of 3D011-08 first, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive doses on 1,3,5day of each week (28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first.Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RPTD).
16412358|NCT05099523|Procedure|taking arterial blood sample through the injector|taking blood samples from patients applied with different oxygen concentrations
16412359|NCT05099510|Biological|NatrunixTM|The active ingredient in the drug product NatrunixTM is XB2001, a recombinant human IgG4 monoclonal antibody specific for human interleukin-1-alpha (IL-1-alpha). The entire XB2001 heavy and light chain sequences are identical to those found in naturally-occurring human IgG4-kappa, with the light and heavy chain variable regions being identical to those originally expressed by a peripheral blood B lymphocyte that was obtained from a healthy individual.
16412360|NCT05099510|Biological|Placebo|Placebo control for NatrunixTM subcutaneous injection.
16412361|NCT05099497|Other|Using Practice Facilitators to Support Physicians|Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.
16412362|NCT05099484|Drug|The MedMilk study|This observational, pragmatic PK study will enroll lactating women who are taking medications that were prescribed by their treating medical provider or as an over-the-counter medication.
16412363|NCT05099471|Drug|Venetoclax; Rituximab|Combination of venetoclax and rituximab
16412364|NCT05099471|Drug|DRC|Combination of Dexamethasone / Rituximab / Cyclophosphamide
16412365|NCT05099458|Biological|Additional blood sampling (100 ml)|only an additional blood volume will be collected at the same time of the standard blood collection for these patients
16412366|NCT05099445|Drug|INCB000928|INCB000928 200 mg will be administered on Day 1 of each treatment period.
16412367|NCT05099432|Procedure|CARMA technique|Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.
16412368|NCT05099419|Device|Repetitive Transcranial Magnetic Stimulation|"rTMS uses pulses of magnetic energy to non-invasively stimulate the brain. The rTMS device to be used in this study is the Magstim Rapid2 Plus1. The rTMS device is connected to an active figure-of-eight coil which rests against the scalp and delivers the magnetic energy to the brain. The rTMS protocol is specified by the parameters of pulse frequency, duration of continuous pulse delivery, intensity, and stimulation location.
~Each participant will receive two different standard rTMS protocols that have been used in past research studies for modulation of pelvic floor tone delivered over the motor cortex in an area that is known to control pelvic floor muscles."
16412369|NCT05099406|Device|Transcranial electrical stimulation|"By applying a low current over the cortex through the scalp, this technique can excite or inhibit the neural activity, thus modulating brain processes like pain perception and inducing relatively sustained changes in cortical excitability and neuroplasticity.
~Home-based transcranial electrical stimulation device consists of a custom headgear with fixed electrode sites and built-in cabling made for a simplistic setup for tDCS/tACS stimulation. Systems are equipped with strict dose control feature that provide reliable control over the intensity and timing of stimulation, turning these devices into a feasible and safe clinical alternative. The equipment is specifically designed for easy and simplistic self-setup and allows the researchers to remotely check the position of electrodes and also monitor the stimulation session."
16412370|NCT05099393|Dietary Supplement|Non Nutritive Sweeteners|"The 2 arms will participate in 3 periods and each of these periods will correspond to the intake of either sucralose, AceK or a placebo.
~The order will be defined randomly. There will be 3 periods and each period will last 4 weeks. 7 to 14 days of break will be respected between each period."
16412371|NCT05099367|Diagnostic Test|Microdialysis, current induced vasodilation|"CIV will be applied over all microdialysis fibers: one perfused with saline, one perfused with a preferential COX-1 blocker; and one perfused with a preferential COX-2 blocker.
~CIV will be applied over all fibers in the following conditions: one perfused with saline, one perfused with fluconazole and L-NMMA, and the last one perfused with lidocaine.Dialysate collection will be performed after each CIV: dermal PGI2 metabolite (6-ketoPGF1α) and other COX-dependent prostanoids or metabolite (e.g. 11-dehydroTXB2) will be collected in the dialysate fluid and quantified. One hour after the last condition, treprostinil will be perfused over all fibers."
16412372|NCT05099367|Diagnostic Test|Skin biopsy|Skin biopsy will be proposed. It will be performed on the internal superior calf (medial gastrocnemius), at a reasonable distance from the foot
16412373|NCT05099367|Diagnostic Test|peri-ulcerated skin biopsy|Non-ulcerated skin from the peri-wound area will be collected. These patient will not undergo all the procedures included in this protocol.
16412510|NCT05062083|Drug|11C-MCI|Injected IV followed by PET scanning
16412374|NCT05099354|Diagnostic Test|autonomic nervous system testing|"Autonomic tests, including heart rate variability (HRV) and baroreceptor sensitivity (BRS), are performed with a 10min ECG with non-invasive or invasive blood pressor measuring during rest. During the time at the stroke unit, this data will be calculated using the existing continuous monitoring.
~Valsalva maneuver during continuous ECG and blood pressure monitoring. The patient will be instructed to exhale against a mouthpiece with a defined resistance for 15 seconds.
~Assessment of the cerebrovascular reserve capacity will be done with continuous transcranial duplex sonography (TCD) and breath holding index (BHI). The patient will be instructed to hold his breath for 30 seconds, 4 times in a row with intervals of 4 minutes. This test will be performed only in responsive and compliant patients."
16412375|NCT05099341|Other|HDRS-17 depression scale|Measuring the severity of depression
16412376|NCT05099341|Biological|Blood sampling|3 tubes of 5 ml
16412377|NCT05099328|Behavioral|Recast Therapy|Recast therapy is when a interventionist uses the child's own productions as a platform for restating or recasting the child's speech with corrections or alterations to focus on a particular syntax target.
16412378|NCT05099328|Behavioral|Syntax Stories|Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
16412379|NCT05099315|Other|not applicable, observational study|Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
16412380|NCT05099302|Other|divert attention|In order to reduce the fears of the children who came to the waiting room before the operation, they watched cartoons and their attention was diverted to another point.
16412381|NCT05099289|Device|AtaCor EV-ICD Lead|Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
16412382|NCT05099276|Drug|Tranexamic Acid Pill|1950 mg tranexamic acid (three capsules) given in post-anesthesia room and three capsules for postop day one and three capsules for postop day two
16412383|NCT05099276|Drug|Placebo|Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two
16412384|NCT05099263|Device|Vivaer Arc Stylus|The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal airway in a single study session.
16412385|NCT05099250|Drug|Bupivacain|local anesthetic agent
16412386|NCT05099250|Drug|magnesium sulfate|In the central nervous system , it has depressant effects, by antagonism at NMDA receptors and through inhibition of release of catecholamines
16412387|NCT05099250|Other|saline|medical solution
16412388|NCT05099237|Device|OURA Ring|All participants will be asked to wear an OURA ring and WithingsScan Watch both at home and whilst in hospital. These devices can record activity, sleep type and duration, resting heart rate and heart rate variability along with a range of other vital signs.
16412389|NCT05099237|Device|WithingsScan Watch|All participants will be asked to wear an OURA ring and WithingsScan Watch both at home and whilst in hospital. These devices can record activity, sleep type and duration, resting heart rate and heart rate variability along with a range of other vital signs.
16412390|NCT05099237|Drug|Isansys Patient Status Engine|Participants in cohort 3 will also be asked to wear Isansys monitoring devices whilst they are in hospital. They will begin to wear the monitors prior to CAR T-cell therapy and continue for 28 days post infusion. Participants will be asked to wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days.
16412391|NCT05099237|Other|Quality of Life Surveys|On a weekly basis participants will be asked to complete satisfaction surveys for the devices they are wearing (ring and watch) and report on their quality of life through standardised questionnaires. These surveys will be delivered electronically to participants via their smartphone or tablet device. There will be an option for participants to report adhoc symptoms via an app on their smartphone or tablet device.
16412392|NCT05099237|Diagnostic Test|Blood Samples|"COHORT 3 ONLY
~Participants in Cohort 3 only will be asked to provide a series of blood samples to measure inflammatory molecules during the study. These will be requested at various intervals during face-to-face visits and whilst the patient is in hospital:
~Baseline blood sample during study enrolment
~Post-lymphodepletion and prior to CAR T-cell infusion (this may be on day -1 or day 0 as needed)
~Post CAR T-cell infusion:
~Day 1
~Day 3
~Day 6
~Day 9
~Day 14 (if the participant remains in hospital)
~A sample of blood will be taken at baseline and a further sample post lymphodepletion and prior to CAR T-cell infusion. Post CAR T-cell infusion, samples will be taken at two timepoints (morning and afternoon) on each of the sampling days."
16412393|NCT05099237|Other|Daily Weights|"COHORT 3 ONLY
~During their inpatient stay, up to a maximum of 28 days, participants in Cohort 3 will be supported to weigh themselves daily using a Withings Body Scale."
16412394|NCT05099224|Behavioral|Mindfulness meditation|similar to the information included in arm/group descriptions
16412395|NCT05099211|Procedure|Muscle biopsies|"Optional
~In pre-training:
~Biopsy performed during the digestive surgery procedure
~Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department."
16412396|NCT05099211|Other|Muscle Strengthening|3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions.
16412397|NCT05099211|Biological|Blood and urine samples|fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
16412398|NCT05099211|Other|Aerobic Training|"3 sessions per week for 18 weeks. Duration: 1 hour Training on a classic pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities."
16412399|NCT05099211|Other|Evaluation 1 pre-surgery|"Carried out at least 15 days before surgery
~st visit:
~Neuromuscular tests
~Nutritional assessment
~Body composition
~nd visit:
~VO2max
~Functional tests Home: Psychometric tests of quality of life + IPAQ Test"
16412400|NCT05099211|Other|Evaluation 2 post-surgery|"st visit:
~neuromuscular tests
~Nutritional assessment
~nd visit:
~Body composition
~Functional tests
~Familiarization with training equipment Home: Psychometric tests of quality of life"
16412541|NCT05036408|Other|Educational Intervention|Attend educational session
16412401|NCT05099211|Other|Intermediate Evaluation 3|performed 9 weeks after the beginning of training Identical tests to evaluation 1
16412402|NCT05099211|Other|Final post-training evaluation 4|Tests identical to evaluation 1
16412403|NCT05099198|Drug|Sitagliptin|Sitagliptin dispensing claim is used as the reference
16412404|NCT05099198|Drug|Glimepiride|Glimepiride dispensing claim is used as the reference
16412405|NCT05099185|Biological|Water-soluble vitamins and trace elements measures|We would like to measure water-soluble vitamins (B1, B6, B9, B12, C) and trace elements (zinc, selenium) in blood and dialysate for the patients treated by online post-dilution hemodiafiltration patients. There measures on blood are done systematically during the half-yearly report of our patients in our hemodialysis center. Only results are collect for the study.
16412406|NCT05099172|Drug|BAY2927088_formulation A|Oral administration
16412407|NCT05099172|Drug|BAY2927088_formulation B_1|Oral administration
16412408|NCT05099172|Drug|BAY2927088_formulation B_2|Oral administration
16412409|NCT05099159|Drug|Elinzanetant (BAY3427080)|120 mg elinzanetant orally once daily
16412410|NCT05099159|Drug|Placebo|Matching placebo orally once daily
16412411|NCT05099146|Behavioral|pictures|pictures with brushing technique demonstrated technique for proper brushing
16412412|NCT05099146|Behavioral|video|video of brushing technique demonstrated technique for proper brushing
16412413|NCT05099146|Behavioral|control|oral hygiene instructions provided
16412414|NCT05099133|Drug|LEO 138559|LEO 138559 is an antibody given by injection just under the skin.
16412415|NCT05099133|Drug|LEO 138559 Placebo|LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559.
16412416|NCT05099107|Drug|Salbutamol (as Salbutamol Sulfate) 2 Mg Oral Tablet|taken 3 times daily for 6 months
16412417|NCT05099107|Drug|Salbutamol Only Product in Oral Dose Form|taken 3 times daily for 6 months
16412418|NCT05099094|Genetic|BD311|Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody
16412419|NCT05099081|Procedure|diode laser application|Local anesthesia will be applied Lesion will be excised with diode laser (Medency, Italy) continuous wave mode 980 nm wave length with an output power 3 W in contact mode
16412420|NCT05099081|Procedure|intra-lesional injection of ethanolamine oleate|"Local anesthesia will be applied Injection of ethanolamine oleate (sclerosing gent) with concentration 5% diluted in distilled water to form 2.5% ethanolamine oleate According to lesion size range from 1.5 to 3 ml of solution will be injected slowly into lesion using gauge needle until leaked from lesion.
~Lesion will be compressed for 5 minutes. Lesion will be observed once a week after injection until it becomes necrotic and falls off spontaneously.
~Repeated injection may be needed."
16412421|NCT05099068|Biological|Blood and tumor samples|Longitudinal molecular profiling of tumor and liquid biopsies.
16412422|NCT05099055|Drug|Dexmedetomidine 0.004 MG/ML [Precedex]|Replacement of intrathecal morphine (100mcg) and fentanyl (15 mcg) for dexmedetomidine 3 mcg in spinal anesthesia
16412423|NCT05099042|Other|Recommendations and re-orientation towards appropriate physical, mental, and social health ressources|Resources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP.
16412424|NCT05099029|Biological|EV71 vaccine|Biological/Vaccine: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) Two vaccinations at 28 days apart
16412425|NCT05099016|Other|Joint Effort|The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and 14) in French language. It aims to support young adults in school who have used cannabis in the past month into taking action on their cannabis use.
16412426|NCT05099016|Other|Brief normative feedback and standard information|The brief normative feedback is based on the frequency of cannabis use use. Participants will also be offered basic reliable non personalized information on lower-risk cannabis use in the form of official public websites.
16412427|NCT05099003|Radiation|Radiation Therapy|Undergo radiation therapy
16412428|NCT05099003|Drug|Selinexor|Given orally
16412429|NCT05098990|Drug|Jinfukang oral liquid|Jinfukang koufuye is a Chinese herbal prescription, which is used in treatment for patients with NSCLC in clinical practice. It has been proved to be capable of preventing the occurrence of metastasis, stabilizing tumor lesions, improving the response rates when combined with chemotherapy, and prolonging the survival period of lung cancer patients.
16412430|NCT05098990|Drug|Platinum-based doublet chemotherapy|Platinum-based doublet chemotherapy as first line therapy has been shown to be efficacious against non-small cell lung cancer.
16412431|NCT05098977|Procedure|Heart rate variability measurement|HRV will be measured at the moment of patients' admission to the cardiac catheterization laboratory on the top of therapy guided by European guidelines. Both, time- and frequency-domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio) of the HRV will be obtained using a validated medical device during 5-minute segments before and after revascularization of the culprit artery. In addition, HRV will be evaluated in ambulatory setting, at 1 month and at 6 months after the index event. Obtained interbeat interval data will be further analysed using a dedicated software in order to derive specified HRV parameters.
16412432|NCT05098977|Procedure|Percutaneous coronary intervention|Coronary angiography and PCI will be performed using femoral or radial approach after local anesthetic infiltration with Lidocaine and arterial sheath placement. Following the culprit lesion detection and guidewire placement, thromboaspiration and glycoprotein IIb/IIIa inhibitors will be left to the operator decision. Also, the choice of coronary stenting technique and stent sizing will be performed according to the operator experience. Antiplatelet and anticoagulant drugs will be administered in concordance with latest European guidelines.
16412433|NCT05098964|Device|pedometer home based rehabilitation|Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan)
16412434|NCT05098964|Other|Exercise training|Hospital based exercise training for 6 weeks
16412435|NCT05098951|Device|Acupuncture|Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
16412436|NCT05098743|Behavioral|Medisafe smartphone mobile application|The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
16413232|NCT04092283|Drug|Paclitaxel|Given IV
16412437|NCT05098743|Behavioral|Printed medication list|Patients will receive a printed out medication list from their electronic medical record.
16412438|NCT05096988|Dietary Supplement|PKU sphere liquid|PKU sphere liquid will be prescribed by the study dietitian based on the patient's individual requirements.
16412439|NCT05096832|Biological|Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)|"Appearance: Creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5 mL) /vial Vaccination route: Intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg (0.5 mL) Immunization schedule: 1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).
~Storage condition: Store at 2-8 °C protected from light Expiry date: 24 months temporarily"
16412440|NCT05096832|Biological|Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)|The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.
16412441|NCT05096286|Device|Ethos Therapy|FDA-approved treatment planning system
16412442|NCT05095272|Biological|HMPBS02-Pv|The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
16412443|NCT05094505|Other|Exercise in normoxia|Exercise at sea level, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.
16412444|NCT05094505|Other|Control diet|Control diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 30% of energy from fat, 20% from protein and 50% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.
16412445|NCT05094505|Other|Exercise in hypoxia|Exercise at 3000m altitude, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.
16412446|NCT05094505|Other|Low carbohydrate diet|Low carbohydrate diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 50% of energy from fat, 20% from protein and 30% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.
16412447|NCT05093556|Behavioral|iCHART - Interactive CBT for Headache And Relaxation Training|IVR based cognitive behavioral therapy for headache
16412448|NCT05092971|Behavioral|Multi-arm bandit tasks|Part 1 to be completed in the clinic. Subject participation is for one part and is pseudo-randomly.
16412449|NCT05092971|Device|Multi-arm bandit tasks|Part 2 to be completed in the scanner. Subject participation is for one part and is pseudo-randomly.
16412450|NCT05092828|Drug|Intrathecal Morphine Injection|In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.
16412451|NCT05092828|Drug|Pain Relieving|Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine
16412452|NCT05092165|Drug|Methylene Blue|1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy
16412453|NCT05092165|Other|Control|Usual care during renal replacement therapy
16412454|NCT05092152|Drug|Esketamine hydrochloride|2 mg per kilogram of body weight
16412455|NCT05092152|Drug|Propofol|1.5 mg per kilogram of body weight
16412456|NCT05091944|Device|web-based birth decision aid|Women in the intervention group receive both usual care and decision support (an interactive web-based birth decision aid). The innovative interactive web-based birth decision aid comprised five components: Component 1-a communication aid video involves 2 expert's talk about how to participate in SDM and prepare self with choice talk, option talk and decision talk(10 minutes )and practice communication skills with clinician(10 minutes); Component 2-overall of the function and features of birth decision aid. Component 3-introduce the benefits and risk of vaginal birth after cesarean; Component 4- the benefits and risk of elective repeat cesarean section; Component 5 -a quit to confirm women's knowledge regarding the two choices and confirm women's values.
16412457|NCT05091905|Drug|Continuous Infusion of ropivacaine 0.2%|A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
16412458|NCT05091905|Drug|Titratable Automated Intermittent Boluses of ropivacaine 0.2%|"The pump will provide ropivacaine 0.2% as an automatic 8 mL bolus once every 2 hours and have a 4 mL patient-controlled bolus with a 30 minute lockout. In addition, for those in the titratable automated intermittent bolus group, the infusion pump will be set in a pause mode that delays initiation of the automated bolus doses by 5 hours (this can be over-ridden by patients if they would like to initiate their perineural infusion earlier than 5 hours). Lastly, subjects in the titratable automated intermittent bolus group will be able to titrate the volume of their automated bolus up or down within the range of 1-16 mL."
16412459|NCT05091294|Other|Local anesthetic injection rate in spinal anesthesia|Administering intrathecal local anesthetics for all patients according to height and weight.
16412460|NCT05090865|Dietary Supplement|Liberalized dietary potassium via fruits and vegetables|On the liberalized dietary potassium intervention, participants will receive groceries delivered to their houses that contain potassium rich fruit and vegetables, that contain more than 200 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 1500 mg of potassium a day from delivered fruit and vegetables, and a daily dietary potassium intake of 3500 mg.
16412461|NCT05090865|Dietary Supplement|Standard dietary potassium restriction|Participants will receive weekly supplementation of lower potassium fruit and vegetables, that deliver less than 125 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 500 mg of K a day from the box, and a daily dietary K intake < 2000 mg. Participants will receive counselling from a registered dietician (RD) to reinforce the potassium restriction.
16412462|NCT05090098|Other|None intervention|None intervention
16412463|NCT05088928|Drug|Apixaban|Direct Acting Oral Anti coagulant
16412464|NCT05088577|Dietary Supplement|Whole egg|Daily consumption of two whole eggs during 8 weeks
16412465|NCT05088577|Dietary Supplement|Annatto-enriched egg|Daily consumption of two whole eggs enriched with annatto during 8 weeks
16412466|NCT05088577|Dietary Supplement|Egg whites - Control|Daily consumption of two eggs whites during 8 weeks
16412467|NCT05088382|Device|LH Urine Test|Test for the qualitative measurement of LH in urine
16412468|NCT05088356|Drug|Purified regulatory T-cells (Treg) plus CD34+ HSPC|"Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells (CD34+ HSPC), Manufactured at SCTT Laboratory, dose 1x10^6 cells/kg to 3x10^6 cells/kg"
16412469|NCT05088356|Drug|Fludarabine|Fludarabine (160 mg/m2)
16412470|NCT05088356|Drug|Melphalan|Melphalan (50 mg/m2) in Arm A; Melphalan (100 mg/m2) in Arm B
16412471|NCT05088356|Device|CliniMACS CD34 Reagent System|The CliniMACS® CD34 Reagent System is a medical device that is used in vitro to select and enrich specific cell populations is manufactured by Miltenyi Biotec
16412472|NCT05088356|Drug|Tacrolimus|4-6ng/mL
16412473|NCT05088356|Drug|Cyclophosphamide|40mg/kg
16412474|NCT05088356|Drug|Plerixafor|Dose 0.24 mg/kg, manufactured by Genzyme
16412475|NCT05088356|Drug|Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent|Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
16412476|NCT05087615|Drug|Metoclopramide|This groups only received metoclopramide 0.2 mg/kg IV Bid as antiemetic in the postoperative period.
16412477|NCT05087615|Drug|Ondansetron|This groups only received ondansetron 8 mg IV Bid as antiemetic in the postoperative period.
16412478|NCT05087615|Drug|Metoclopramide and Ondanteron|This groups received both metoclopramide 0.2 mg IV Bid and ondansetron 8 mg IV/Bid as antiemetics in the postoperative period.
16412479|NCT05087615|Drug|Granisetron|This groups only received granisetron 2 mg IV Bid as antiemetic in the postoperative period.
16412480|NCT05087355|Diagnostic Test|PCR or antigen test for Covid 19 or Inluenza|PCR or antigen test for Covid 19 or Inluenza
16412481|NCT05086744|Drug|Iptacopan|Iptacopan 200 mg BID
16412482|NCT05085197|Drug|STSA-1005 injection|Intravenous injection
16412483|NCT05085197|Drug|Placebo|Intravenous injection
16412484|NCT05085197|Drug|STSA-1005 injection|Intravenous injection
16412485|NCT05085197|Drug|Placebo|Intravenous injection
16412486|NCT05085197|Drug|STSA-1005 injection|Intravenous injection
16412487|NCT05085197|Drug|Placebo|Intravenous injection
16412488|NCT05085197|Drug|STSA-1005 injection|Intravenous injection
16412489|NCT05085197|Drug|Placebo|Intravenous injection
16412490|NCT05083780|Drug|Chlorphenesin Carbamate, Hydroxychloroquine|In addition to the mFOLFIRINOX therapy(backbone therapy), chlorphenesin carbamate 250 mg, and hydroxychloroquine 200 mg will be administered orally twice daily for up to 48 weeks.
16412491|NCT05083078|Drug|Guselkumab|Guselkumab will be administered subcutaneously.
16412492|NCT05083078|Drug|Risankizumab|Risankizumab will be administered subcutaneously.
16412493|NCT05082948|Other|Suture fixation of stent|Esophageal stent will be placed in the standard of care fashion by the endoscopists using standard gastroscopes. Covered self-expanding metal stent will be placed as per endoscopist preference. After esophageal stent placement, endoscopic suturing will be performed in cases of patients randomized to suture fixation.
16412494|NCT05082948|Other|Non suture|Standard placement of stent without suture fixation
16412495|NCT05082155|Drug|Bupivacaine 0.25%|Bupivacaine 0.25% will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
16412496|NCT05082155|Drug|Normal Saline|Normal saline will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
16412497|NCT05081804|Dietary Supplement|Carbohydrate Preoperative Drink|Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery
16412498|NCT05081700|Drug|All patients in the study will be treated with ocrelizumab|300 mg of OCR IV infusion will be given on Day 0 followed by a second dose of 300 mg OCR 14 days later ± 2 days, and then 600 mg of OCR as a single infusion will be given every 24 weeks thereafter per standard medical care.
16412499|NCT05080244|Dietary Supplement|Probiotics|2 strains 10x10^9 UFC/capsule
16412500|NCT05080244|Dietary Supplement|Placebo|Potato starch and magnesium stearate
16412501|NCT05078879|Drug|Empagliflozin|This is an open-label pilot study to evaluate the efficacy, safety, and tolerability of empagliflozin as a treatment for severe congenital neutropenia (SCN) in patients with glucose-6-phosphatase 3 (G6PC3) deficiency. Participants will be on a 12-month daily regimen of empagliflozin at a starting dose of 10 mg (phase A), which may be increased after 2 months to 25 mg (phase B). Evaluate the safety and efficacy of the biomarker response (the change in absolute neutrophil count [ANC] after one year of empagliflozin treatment relative to baseline ANC prior to drug treatment) in patients with G6PC3 deficiency.
16412502|NCT05078502|Dietary Supplement|Vitamin D3|One capsule of vitamin D3(40000IU) weekly for 8 weeks
16412503|NCT05076396|Drug|PM14|PM14 drug product is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 5.0 mg of the active moiety. Patients will receive PM14 as an i.v. infusion in a total volume of 100 mL of 0.9% sodium chloride at the first three dose escalation levels. Thereafter, the volume of infusion can be increased to 250 mL.
16412504|NCT05073536|Device|mini-sized MCE|Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.
16412505|NCT05073536|Device|normal-sized MCE|Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.
16412506|NCT05070585|Dietary Supplement|Isothiocyanate rich sprouts|Isothiocyanate rich sprout juice consumption for 1 week
16412511|NCT05060835|Other|Virtual assistants offering medical recommendations to health care profesionals|the project will interconnect, following a federated approach, large, distributed cancer imaging repositories, currently used for AI tools training and validation, with patient registries and EHRs of cancer-related data and supports exploitation of relevant unstructured data through novel Natural Language Processing (NLP) tools
16412512|NCT05058664|Behavioral|A-F texting component|Over the course of the 6-week intervention parents in the A-F condition will receive 1 message each day.
16412513|NCT05058664|Behavioral|P-F texting component|Over the course of the 6 week intervention, parents will receive between 1-2 messages, depending on randomization (in addition to A-F component messages)
16412514|NCT05057949|Drug|Larotinib Itraconazole Rifampin|Larotinib Itraconazole Rifampin
16412515|NCT05054140|Drug|IMU-838|IMU-838 tablets
16412516|NCT05054140|Drug|Placebo matching IMU-838|Placebo matching IMU-838 tablets
16412517|NCT05052658|Procedure|Neuraxial block placement|The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.
16412518|NCT05050916|Other|Placebo|a capsule absent of active ingredient
16412519|NCT05050916|Dietary Supplement|Vitamin D|This is a Phase II randomized, dose-ranging clinical trial including 1) a within-woman comparison of hormones pre- and post-supplementation and 2) a comparison across women of two different dose levels. After recruitment, there will be two phases: Phase 1 will follow all women for one menstrual cycle prior to supplementation; blood will be assayed for 25OHD. Phase 2 includes only: 1) women with less than 20 ng/ml 25OHD ('deficient') OR 2) a small ~10% sample of women with >20 ng/ml 25OHD ('sufficient') as the placebo group. During Phase 2, deficient women will be randomized (2:3) to receive a blinded dose of either 4,200 IU or 50,000 IU of vitamin D supplementation per week and followed for three more menstrual cycles. Hormone levels will be compared between the pre-and post-supplementation cycles as the primary analysis. The primary aim will test: if mid-luteal progesterone, rate of estrogen rise and pre-ovulatory LH are higher in vitamin D supplemented cycles.
16412520|NCT05047250|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.
16412521|NCT05047250|Drug|Pemetrexed|Pemetrexed will be administered by IV infusion at a dose of 500 mg/m² on Day 1 of each 21-day cycle. Participants who do not experience disease progression per RECIST v1.1 after completing (four or six cycles of) induction treatment, will continue maintenance treatment with pemetrexed, given on Day 1 of each 21-day cycle until disease progression per RECIST v1.1.
16412522|NCT05047250|Drug|Carboplatin|Carboplatin will be administered by IV infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine or paclitaxel.
16412523|NCT05047250|Drug|Cisplatin|Cisplatin will be administered by IV infusion at a dose of 75 mg/m².
16412524|NCT05047250|Drug|Gemcitabine|Gemcitabine will be administered by IV infusion at a dose of 1,250 mg/m² (in combination with cisplatin) or 1,000 mg/m² (in combination with carboplatin) on Days 1 and 8 of each 21-day cycle.
16412525|NCT05047250|Drug|Paclitaxel|Paclitaxel will be administered by IV infusion at a dose of 175 mg/m2 on Days 1 of each 21-day cycle.
16412526|NCT05044195|Biological|aQIV|Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
16412527|NCT05044195|Biological|Comparator QIV|Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
16412528|NCT05039619|Drug|Obinutuzumab|Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
16412529|NCT05039619|Drug|Placebo|Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
16412530|NCT05039619|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
16412531|NCT05039619|Drug|Acetaminophen/paracetamol|Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
16412532|NCT05039619|Drug|Diphenhydramine hydrochloride (HCl)|Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
16412533|NCT05039619|Drug|Methylprednisolone|Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
16412534|NCT05039619|Drug|Prednisone|Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.
16412535|NCT05039554|Behavioral|Acceptance and commitment therapy|Intervention will be provided over 12 weeks with weekly 1-hour sessions using a group format with the overall goal to foster psychological flexibility. ACT will assist participants to notice their internal triggers; abandon their attempts to manage these triggers via active avoidance (suppression or other control-based strategies including opioid or other substance use) and to make commitments to engage in behaviors consistent with their chosen values or goals (rather than allowing negative thoughts, feelings, or pain symptoms to dictate behavior).
16412536|NCT05039554|Other|Valera Smartphone Application|For those randomized to a cohort with the Valera app, the app (and cellphones if necessary) will be provided. The app is HIPAA compliant and IRB approved. It consists of 2 components: a participant-facing Smartphone Application and a corresponding online Care Manager Dashboard. Smartphones and internet access will be provided as needed for the 12-week study duration.
16412537|NCT05039554|Other|Treatment as Usual|TAU for BUP treatment typically consists of regularly scheduled visits every 1-2 months with primary care physicians and/or nurse care managers in Montefiore primary care settings. During these 15-min follow up visits, providers typically inquire about opioid and other substance use, opioid craving, symptoms of opioid withdrawal, and risk of relapse. In addition, at each visit, urine toxicology tests are conducted and providers review results of prior urine toxicology tests with patients. If opioid or other substance use is ongoing, typically providers will intensify treatment, including increasing the frequency of visits, referring to social workers or mental health providers, recommending self-help groups, and/or recommending outpatient drug treatment programs (e.g., individual and group counseling).
16412538|NCT05037500|Drug|Decitabine and Cedazuridine|Given PO
16412539|NCT05037500|Drug|Enzalutamide|Given PO
16412540|NCT05036408|Other|Behavioral, Psychological or Informational Intervention|Participate in group psychological intervention
16412542|NCT05036408|Procedure|Manipulative and Body-Based Intervention Procedure|Undergo osteopathic manual treatments
16412543|NCT05036408|Behavioral|Occupational Therapy|Participate in occupational therapy
16412544|NCT05036408|Other|Physical Activity|Participate in physical activity
16412545|NCT05036408|Procedure|Physical Therapy|Participate in physical therapy
16412546|NCT05036408|Other|Questionnaire Administration|Ancillary studies
16412547|NCT05035615|Other|IUO Acute Leukemia Panel|This Investigational Panel , comprised of 6 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of immature hematopoietic cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell acute lymphoblastic leukemia or acute myeloid leukemia.
16412548|NCT05035420|Device|Fitbit|Performance of the NIRS biosensor will be explored in comparison to this commercial wearable.
16412549|NCT05035420|Device|Douglas Bag|The Douglas Bag will be used for inducing hypercapnia.
16412550|NCT05035420|Device|Periflux 6000 EPOS|Tissue oxygen saturation measured by the Periflux 6000 will be compared with peripheral tissue saturation measured with the NIRS biosensor both at rest and during the induced hypercapnia, paced breathing and breath holding.
16412551|NCT05035420|Device|BIOPAC|The BIOPAC system will be used to record the PPG signal, cardiovascular hemodynamics, and respiratory parameters in order to noninvasively monitor the heart rate, heart rate variability, respiratory rate, respiratory effort index, and arterial oxygen saturation.
16412552|NCT05035420|Device|Flowmet|Flowmet will be used for a measurement of arterial blood flow within the finger or toe. Flowmet outputs a PPG waveform that will be compared with the NIRS biosensor.
16412553|NCT05035420|Device|NIRS|a. Each subject will be monitored with the multimodal system for 10 minutes while sitting quiescent on a chair in resting position. All screening index parameters will be collected and recorded. b. Each subject will be studied for approximately 60-80 minutes while being exposed to a mild Hypercapnia (5% CO2), paced breathing and breath holding followed by a 10-minute recovery time after each task.
16412554|NCT05035407|Drug|IL-2 (Aldesleukin)|dose of 720,000 IU/kg (based on total body weight) as an intravenous bolus over a 15 minute period beginning within 24 hours of cell infusion and continuing for up to four days (maximum 12 doses).
16412555|NCT05035407|Drug|Cyclophosphamide|30 mg/kg IV infusion over 1 hour (+ 10 min) Once daily x 2 doses (Days -6 and -5)
16412556|NCT05035407|Biological|KK-LC-1 TCR|1 x 108 transduced KK-LC-1 TCR T cells
16412557|NCT05035407|Drug|Fludarabine|25 mg/m2 IV infusion over 30 minutes (+ 10 min) To be administered following completion of cyclophosphamide. Once daily x 5 doses (Days -6, -5, -4, -3, -2)
16412558|NCT05033041|Drug|Study drug metoclopramide|Intravenous administration of 4 mg metoclopramide
16412559|NCT05033041|Drug|Study drug placebo administration|Intravenous administration of placebo (sterile normal saline)
16412560|NCT05030038|Biological|Fecal swab collection|Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
16412561|NCT05030038|Biological|Blood samples|Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
16412562|NCT05027958|Drug|Tuberculin Purified Protein Derivative|PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU
16412563|NCT05027945|Drug|Post-Transplant Cyclophosphamide (PTCY)|Post-Transplant Cyclophosphamide: 50 mg/kg IV daily over 2 hours on days +3 and +4, dosed according to ideal body weight
16412564|NCT05027945|Drug|Cyclophosphamide (CY)|For 7/8 Matched Related or Unrelated or Haploidentical Donor, prior to transplant 14.5 mg/kg IV daily on days -6 and -5
16412565|NCT05027945|Drug|Fludarabine|40 mg/m2 IV over 30 mins daily For 8/8 Matched Related or Unrelated Donor Fludarabine dose will be on days -6, -5, -4, and -3 For 7/8 Matched Related or Unrelated or Haploidentical Donor Fludarabine dose will be on days -6, -5, -4, -3, and -2
16412566|NCT05027945|Radiation|Total Body Irradiation (TBI)|For 7/8 Matched Related or Unrelated or Haploidentical Donor, 200cGy on day -1
16412567|NCT05027945|Drug|Busulfan|AUC Targeted Dose based on busulfan test dose PKs, IV infusion over 3 hours once daily (3.2 mg/kg IV per day will be the default dose) per the below time frame: For 8/8 Matched Related or Unrelated Donor Busulfan dose will be on days -6, -5, and -4 For 7/8 Matched Related or Unrelated or Haploidentical Donor Busulfan dose will be on days -4 and -3
16412568|NCT05027945|Drug|Sirolimus|Sirolimus: on day +5 5mg PO loading dose q4h for 3 doses, then 5 mg PO q24h starting on day +6
16412569|NCT05027945|Drug|Mycophenolate mofetil (MMF)|Mycophenolate mofetil (MMF): 15 mg/kg IV over 2 hours BID starting on day +5 until approximately day +35 (+/-2 days)
16412570|NCT05027945|Drug|Busulfan test dose|0.8 mg/kg IV over 2 hours
16412571|NCT05027945|Procedure|Allogeneic HSCT|stem cell transplant on day 0
16412572|NCT05027932|Biological|BPL-1357|BPL-1357 contains 4 whole inactivated avian influenza viruses: A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9. It will be administered either IM or IN depending on the assigned treatment group.
16412573|NCT05027932|Other|IM Placebo|The placebo will be 1.2 mL normal saline in a syringe administered IM
16412574|NCT05027932|Other|IN Placebo|0.6 mL normal saline in two syringes administered IN, depending on the assigned treatment group.
16412575|NCT05027490|Other|CANUT support|CANUT support includes delivery of the CANUT guide (food guide developed by Paul Bocuse Institute from previous results) ; it will be given to patient with explanations about the use of the guide. This also includes 2 calls from a dietician, performed between the 1st and the 3rd chemotherapy cycle to help patient personally with their food side effects.
16412576|NCT05027490|Other|Anthropometric measures|These measures include weight, waist size, hip size and brachial circumference
16412577|NCT05027490|Other|Prehension strength measurement|Prehension strength will be assessed thanks to a hand grip device, that makes it possible to measure strength of all fingers, hands, wrists and forearms muscles
16412578|NCT05027490|Behavioral|QVA Questionnaire|Food quality of life questionnaire
16412579|NCT05027490|Behavioral|QLQ C30 Questionnaire|Quality of Life questionnaire Core 30
16412846|NCT04711252|Drug|Anastrozole|Dosage formulation: Anastrozole tablets will be administered orally.
16413233|NCT04092283|Drug|Pemetrexed Disodium|Given IV
16412580|NCT05027490|Behavioral|Scratch & Snif Test|The Scratch & Snif Test is used to assess olfactory capacities : patient has to scratch a box on a card, smell it and recognize the scent amongst a list of propositions
16412581|NCT05027490|Behavioral|Taste Strip Test|The Taste Strip Test is used to assess taste capacities : strips impregnated with different concentrations of the 5 basic taste qualities (sweet, sour, acid, bitter, umami) are successively placed on patient's tongue ; patient has to identify the taste bit by bit.
16412582|NCT05027490|Behavioral|24 H feed back questionnaire|This questionnaire describes patient's food and drink intakes during the last 24 ours
16412583|NCT05027490|Behavioral|Condiment questionnaire|This questionnaire used to assess condiments consumption
16412584|NCT05027490|Behavioral|Tobacco questionnaire|This questionnaire used to assess tobacco consumption
16412585|NCT05027490|Other|Nutrition interview|This interview will be conducted by a dietician
16412586|NCT05027230|Drug|STSP-0601 for Injection|A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
16412587|NCT05027230|Drug|STSP-0601 for Injection|A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
16412588|NCT05025397|Drug|Danavorexton|Danavorexton intravenous infusion.
16412589|NCT05025397|Drug|Danavorexton Placebo|Danavorexton placebo-matching intravenous infusion.
16412590|NCT05025397|Drug|Propofol|Propofol intravenous bolus.
16412591|NCT05025397|Drug|Sevoflurane|Sevoflurane inhalation.
16412592|NCT05025397|Drug|Propofol|Propofol intravenous infusion.
16412593|NCT05025384|Other|Acupressure|"Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours.
~At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 hours if there are no adverse effects such as skin irritation."
16412594|NCT05024214|Drug|Lenvatinib + Envafolimab|"Drug: Lenvatinib Lenvatinib will be administered with water orally once a day (with or without food) continuously in 28-day treatment cycle.
~Drug: Envafolimab Envafolimab will be administered as a dose of 400 mg Q4W, subcutaneous injection in 28-day treatment cycle."
16412595|NCT05024214|Drug|Sunitinib|Drug: Sunitinib Sunitinib will be administered with water orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) in 42-day treatment cycle.
16412596|NCT05023525|Drug|HSK31858, tablet|Starting dose in single ascending dose: 5 mg
16412597|NCT05023525|Drug|Placebo, tablet|Matching placebo
16412598|NCT05018091|Drug|Dexamethasone 4mg|4mg intravenous dexamethasone, administered shortly after induction of anesthesia
16412599|NCT05018091|Drug|Dexamethasone 8 Mg/mL Injectable Suspension|8mg intravenous dexamethasone, administered shortly after induction of anesthesia
16412600|NCT05018091|Drug|Dexamethasone 16mg|16mg intravenous dexamethasone, administered shortly after induction of anesthesia
16412601|NCT05017571|Drug|Colchicine|Colchicine 1 capsule (0.6 mg) per day
16412602|NCT05017571|Drug|Placebo|Placebo 1 capsule per day
16412603|NCT05016765|Device|Active, self-directed electrical stimulation of the right median nerve|Electrical stimulation of the right median nerve (12 Hz, pulse width 200µs), initially at the threshold needed to see movement of the right thumb with stimulation. After initial training with the device and education in the rationale for suprathreshold stimulation, participants will choose timing and intensity of stimulation based on their momentary symptom severity and their experience with the treatment since the beginning of the study.
16412604|NCT05013736|Device|Magnetic Resonance Imaging|3 Tesla Discovery MR750 MRI scanner (GE Healthcare, Waukesha, WI) will be used to perform structural imaging, diffusion MRI, relaxometry and microstructural imaging. The exact scan length and parameters of each scan type (T1, T2, DWI) will be set for this study to optimize the quality of data and decrease the length of scanning session for each type of scan. All of the imaging methods have been previously implemented at UW-Madison. Each sequence will take approximately 5-10 minutes.
16412605|NCT05013736|Behavioral|Behavioral Assessments|The behavioral assessments (GMA: General Movements Assessment; HINE: Hammersmith Infant Neurological Examination; Bayley-IV, Bayley Scales of Infant and Toddler Development 4th ed) are infant and age-specific and will be administered by trained pediatric occupational and physical therapists.
16412606|NCT05012098|Drug|Bintrafusp alfa / M7824|Participants will be treated with bintrafusp alfa 1200 mg every 2 weeks for 26 doses.
16412607|NCT05009979|Drug|F18-FDG|Within approximately 2 weeks of each 18F-DCFPyL PET/CT scan, participants will be scanned with a 18F-FDG PET/CT imaging at the NIH Clinical Center using standard procedures. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
16412608|NCT05009979|Device|MRI|A standard of care CT and/or MRI will be performed within 4 months of each 18F-DCFPyL PET/CT.
16412609|NCT05009979|Device|CT|A standard of care CT and/or MRI will be performed within 4 months of each 18F-DCFPyL PET/CT.
16412610|NCT05009979|Drug|F18-DCFPyL|Each subject will receive a single IV dose of 18F-DCFPyL by bolus injection at a rate of approximately 1 ml/3-5 sec. The maximum amount of injected active drug will be less than 4.02 ?g. The injection will be followed by a 10 ml saline flush (sodium chloride IV infusion 0.9% w/v) over ~10sec. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi. A static whole-body PET/CT (top of the head to mid-thighs) will be performed 2 hours post 18F-DCFPyL injection. Only a single injection of 18F-DCFPyL is required.
16412656|NCT04956809|Drug|Dapagliflozin 10Mg Tab|This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.
16412657|NCT04956809|Drug|Placebo|This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.
16412696|NCT04920643|Procedure|Ultrafiltration|Ultrafiltration is used during cardiac surgery with cardiopulmonary bypass to remove both fluid and small molecules such as inflammatory cytokines from the patient's circulation.
16413114|NCT04334941|Drug|Talazoparib|Given PO
16412611|NCT05009459|Behavioral|eVIS|To facilitate individualized physical activity levels within the Swedish IPRP setting, an eVISualisation (eVIS) of physical activity and pain intervention has been systematically developed. eVIS is designed to target facilitating mechanisms for behavior change, such as outcome expectations, self-monitoring, self-evaluation, and self-efficacy, which are theoretically framed by the Social Cognitive Theory by Bandura. In eVIS, objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities30-34 and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.
16412612|NCT05004831|Drug|fruquintinib plus TAS-102|fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W
16412613|NCT05004688|Biological|Biological/Vaccine: Bacillus Calmette-Guerin (BCG)|Two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
16412614|NCT05004688|Other|Placebo|Two injections of 0.1ml saline (diulent used for the vaccine) will be given 4 weeks apart.
16412615|NCT05003895|Drug|Cyclophosphamide|Daily x 3 doses on Day -3, -2, -1 300 mg/m2 IV infusion (200 mg/m2 in Dose Level -1)
16412616|NCT05003895|Biological|CAR-T cell|Single infusion on Day 0
16412617|NCT05003895|Drug|Fludarabine|Daily x 2 doses on Day -2 and -1 30 mg/m2 IV infusion administered following cyclophosphamide
16412618|NCT05002088|Device|Transcatheter Aortic Valve Replacement|Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
16412619|NCT05000216|Biological|Moderna mRNA-1273|Administration: One dose administered intramuscularly.
16412620|NCT05000216|Biological|BNT162b2|Administration: One dose administered intramuscularly.
16412621|NCT05000216|Biological|Ad26.COV2.S|Administration: One dose administered intramuscularly.
16412622|NCT05000216|Drug|IS (MMF or MPA)|Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
16412623|NCT05000216|Drug|IS (MTX)|Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
16412624|NCT05000216|Biological|IS (B cell depletion therapy)|Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
16412625|NCT04996641|Procedure|Root canal treatment and crown|Pre-radiation one day root canal treatment and CAD/CAM chair side fabricated crowns for head and neck cancer patients
16412626|NCT04992598|Other|Hypnosis session|Hypnosis session will precede therapeutic strategies and reduction
16412627|NCT04992598|Procedure|Reduction|All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.
16412628|NCT04992208|Biological|Experimental Group|SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
16412629|NCT04991506|Drug|ES102|The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)
16412630|NCT04991506|Drug|JS001|JS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.
16412631|NCT04989283|Biological|Atezolizumab|Given IV
16412632|NCT04989283|Drug|Carboplatin|Given IV
16412633|NCT04989283|Drug|Cisplatin|Given IV
16412634|NCT04989283|Drug|Etoposide|Given IV
16412635|NCT04989283|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16412636|NCT04989283|Drug|Paclitaxel|Given IV
16412637|NCT04989283|Drug|Pemetrexed|Given IV
16412638|NCT04989283|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16412639|NCT04987671|Drug|AMX0035|Fixed dose combination of Sodium Phenylbutyrate and taurursodiol.
16412640|NCT04985773|Device|Lacrosse NSE ALPHA coronary dilatation catheter|The Lacrosse NSE ALPHA is a rapid exchange percutaneous transluminal coronary angioplasty balloon catheter with non-slip element nylon threads that focus dilatation force to reduce balloon slippage during inflation.
16412641|NCT04985695|Drug|Epidural analgesia|All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.
16412642|NCT04985695|Drug|Bilateral rectus sheath block|Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump
16412643|NCT04985695|Procedure|Laparotomy|A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
16412644|NCT04972968|Drug|ABBV-154|Subcutaneous Injection
16412645|NCT04972968|Drug|Placebo|Subcutaneous Injection
16412646|NCT04972968|Drug|Glucocorticoid|Oral Tablet
16412647|NCT04971161|Biological|allo-APZ2-CVU|Suspension of ABCB5-positive dermal mesenchymal stromal cells. One topical application with a syringe.
16412648|NCT04971161|Drug|Placebo|One topical application with a syringe
16412649|NCT04969224|Drug|ELX/TEZ/IVA|FDC tablet for oral administration.
16412650|NCT04969224|Drug|IVA|Tablet for oral administration.
16412651|NCT04967443|Drug|Prazosin HCl 2mg|Prazosin HCL 1 X 2 mg capsule.
16412652|NCT04967443|Drug|Prazosin HCl 1 mg|Prazosin HCl 2 X 1 mg capsule.
16412653|NCT04967443|Drug|Prazosin HCl 5 mg|Prazosin HCL 1 X 5 mg capsule.
16412654|NCT04965909|Other|Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement.|Online group therapeutic program (small groups), applied for 3 months.
16412655|NCT04964895|Other|Questionnaires|"Patients will fill in multiple questionnaires for this study :
~EORTC quality of life questionnaire (QLQ) QLQ-C30, EORTC Shq22, Male Sexual Health Questionnaire (MSHQ) only for Men, FSFI (only for women)"
16412658|NCT04955405|Other|The seven visit telemedicine protocol|The transition of care team (pharmacist, advanced practice provider, social worker) will conduct an initial visit as a team with the patient using the telemedicine platform. During the visit, the team will assess the clinical, social, and pharmaceutical needs of the patient. The transition of care team will then meet to discuss the specific needs of the patient and to develop a care plan for the next 6 telemedicine visits. Either the social worker or the advanced practice provider will conduct the next 6 visits. The pharmacist will provide medication counseling as needed and recommended by the entire care team. The next 3 visits will occur weekly, the following 2 visits will occur biweekly, and the remaining 1 visit will occur at some point during the third month.
16412659|NCT04950998|Behavioral|Moving Up - A|Moving Up - A is a physical activity smartphone app for persons with mild cognitive impairment or mild forms of dementia. The app includes a personally tailored set of messages, tips, strategies, and tasks designed to increase physical activity levels and disrupt extended periods of sedentary time. Users also have the ability to track their steps and and sedentary behavior time as well as their progress towards activity goals.
16412660|NCT04950309|Device|SQUID MEG|MEG recordings acquired on a standard whole brain SQUID MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used.
16412661|NCT04950309|Device|OPM MEG|MEG recordings acquired on an investigational OPM MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used.
16412662|NCT04949594|Device|TENS|application on muscles where pain is situated (cervical)
16412663|NCT04946656|Procedure|sphenopalatine ganglion block|The sphenopalatine ganglion will be blocked with bupivacaine for this study
16412664|NCT04946318|Drug|CSJ117|CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) capsules for inhalation once daily delivered via Concept1 inhalation device for 12 or 24 weeks.
16412665|NCT04946318|Drug|Placebo|Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.
16412666|NCT04944784|Drug|Reldesemtiv|Reldesemtiv Oral Tablet
16412667|NCT04944784|Drug|Placebo|Placebo Oral Tablet
16412668|NCT04942327|Behavioral|Interview|This will be evaluated through a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phases.
16412669|NCT04940065|Other|Kesimpta|Prospective observational cohort study. There is no treatment allocation.
16412670|NCT04939467|Drug|Pirfenidone 267 mg Oral Tablet|Fixed sequence use of active product, TID
16412671|NCT04939467|Drug|Nintedanib 150 mg Oral Capsule|Fixed sequence use of active product, BID
16412672|NCT04939467|Drug|BLD-0409 750 mg Oral Tablet|Fixed sequence use of active product, QD
16412673|NCT04938271|Device|HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve|Using a bluetooth connected iPhone, subject activates the HEAL-122 electroceutical device that is docked onto an e-textile sports knee sleeve worn on the osteoarthritic knee
16412674|NCT04933617|Biological|Rituximab|Rituximab 375 mg/m2 IV per protocol on Day 1 of each cycle up to 6 cycles
16412675|NCT04933617|Drug|Etoposide|Etoposide 50 mg/m2/day CIVI on Days 1-4 of each cycle up to 6 cycles
16412676|NCT04933617|Biological|Copanlisib|Copanlisib IV is administered at a fixed dose (30 mg, 45 mg, or 60 mg) on days 1 and 5 of each 21-day cycle for up to 6 cycles
16412677|NCT04933617|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 IV on Day 5 of each cycle up to 6 cycles
16412678|NCT04933617|Drug|Doxorubicin|Doxorubicin 10 mg/m2/day CIVI on Days 1-4 of each cycle up to 6 cycles
16412679|NCT04933617|Drug|Vincristine|Vincristine 0.4 mg/m2/day (no cap) CIVI on Days 1-4 of each cycle up to 6 cycles
16412680|NCT04933617|Drug|Prednisone|Prednisone 60 mg/m2 PO BID Days 1-5 (total 120mg/m2/day)
16412681|NCT04933539|Drug|Dexamethasone|Dexamethasone PO/IV (for Cycles 1-4: Dexamethasone 40 mg IV/PO on days 1, 8, 15, 22; for Cycles =5: Dexamethasone 20 mg IV/PO on days 1, 8, 15, 22); for up to 12 cycles
16412682|NCT04933539|Drug|Carfilzomib|Carfilzomib IV (for Cycles 1-2: 20 mg/m2 IV on day 1, 56 mg/m2 IV on days 8, 15; Cycles =2: 56/m2 IV on days 1, 8, 15); for up to 12 cycles
16412683|NCT04933539|Biological|Daratumumab|Daratumumab SC 1800 mg (Cycles 1-2: Days 1, 8, 15, 22; Cycles 3-6: Days 1, 15; Cycles =7: Days 1 of the 28-day cycle); up to 36 cycles total
16412684|NCT04932447|Behavioral|Inspiratory Muscle Strength Training|30 breaths/ day, 5 days/week for 24 weeks.
16412685|NCT04931251|Behavioral|Financial Navigation|providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer
16412686|NCT04928287|Biological|HB-adMSCs|HB-adMSCs will be administered intravenously to study participants who qualify.
16412687|NCT04928287|Other|Placebo|Placebo will be administered intravenously to study participants who qualify.
16412688|NCT04926818|Drug|Fingolimod|Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
16412689|NCT04926818|Drug|Ofatumumab|Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight).
16412690|NCT04926818|Drug|Siponimod|Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight).
16412691|NCT04926818|Other|Fingolimod placebo|Fingolimod matching placebo capsule
16412692|NCT04926818|Other|Siponimod placebo|Siponimod matching placebo tablet
16412693|NCT04926818|Other|Ofatumumab placebo|Ofatumumab matching placebo autoinjector
16412694|NCT04925830|Behavioral|Heart rate variability biofeedback; haemoncephalography biofeedback|Ten 25-minute weekly heart rate variability biofeedback and 30 minute haemoencephalogrphy biofeedback sessions
16412695|NCT04925622|Diagnostic Test|Complex eye movement exam|"Subjects will undergo a complex eye exam which will capture fixation, optokinetic nystagmus, guided saccades, microsaccades, smooth pursuit, and pupillometry.
~Eye tracking equipment will be set and calibrated to the participant who will then perform the full 10 minute testing protocol with instructions from the investigator. After this, they will take a five minute break. The oculomotor testing protocol will be repeated twice."
16412794|NCT04807387|Device|Vaginal Stent|Vaginal stent chosen from A or B that is the most comfortable
16412697|NCT04920136|Procedure|Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)|A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
16412698|NCT04920136|Procedure|Free Gingival graft|Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.
16412699|NCT04916678|Other|R-TEP EMDR intervention|"During the intervention period, trained psychologists are available in the ER and will provide preferentially a short early 1-hour R-TEP EMDR intervention for patients selected with high risk of PCLS. Patient's selection will be conducted using a score developed in previous studies. If therapist considers R-TEP EMDR unsuitable, he could provide another type of intervention (such as reassurance) that will be recorded.
~When no high-risk patient is identified, the therapist could assess other patients and treat them if judged necessary. In this context, they could provide either a R-TEP EMDR or short intervention such as reassurance according to therapist assessment."
16412700|NCT04915183|Drug|Atorvastatin|For the interventional arm of the study, subjects will be provided with atorvastatin (20 mg) or placebo to be taken daily by mouth or by feeding tube. The tablets may be taken whole or crushed according to patient swallowing capabilities and preference.
16412701|NCT04915183|Other|Placebo|placebo will be formulated to also contain a white powder such that the atorvastatin and placebo are indistinguishable even if a capsule is opened.
16412702|NCT04914520|Biological|VN-0200|VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
16412703|NCT04914520|Biological|Placebo|Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
16412704|NCT04912115|Drug|Ketamine|Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug pharmacologically classified as an NMDA receptor antagonist (also noted to be a weak opioid receptor agonist).
16412705|NCT04912115|Drug|Midazolam|Midazolam is a benzodiazepine used for anesthesia, procedural sedation, trouble sleeping, and severe agitation.
16412706|NCT04911790|Biological|Experimental Group|SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
16412707|NCT04911660|Drug|Empagliflozin 25 MG|1 empagliflozin 25 mg capsule per day for 14 days
16412708|NCT04911660|Other|Placebo|1 placebo capsule per day for 14 days
16412709|NCT04910919|Dietary Supplement|Honey|Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.
16412710|NCT04910919|Other|Standard of Care|The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).
16412711|NCT04909723|Combination Product|NOV-001|NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
16412712|NCT04909723|Biological|NB1000S|A recombinant live biotherapeutic product.
16412713|NCT04909723|Drug|NB2000P|A botanically derived polysaccharide.
16412714|NCT04909723|Drug|Placebo|Placebo
16412715|NCT04902443|Drug|Pomalidomide|Pomalidomide will be administered as an oral planned starting dose of 3 mg daily. Pomalidomide will be given from day 1 to day 21 of each cycle
16412716|NCT04902443|Drug|Nivolumab|Nivolumab will be administered IV at a dose of 480 mg at day one of each cycle, except for cycle one when it will be administered on day 8. One cycle equals 28 days
16412717|NCT04900402|Other|Survey|International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL)
16412718|NCT04896593|Behavioral|Smartphone App|Smartphone app teaching suicide prevention skills.
16412719|NCT04896307|Other|Survey|Survey
16412720|NCT04896073|Drug|Minnelide|Administered orally (2 mg) once daily for 21 days of 28-day cycles for 12 cycles.
16412721|NCT04892914|Device|Embr thermal device|Participants use the Embr thermal device for 4 weeks
16412722|NCT04890093|Drug|PEN-866|PEN-866 will be given as an IV infusion once every week for the first two consecutive weeks out of every three-week (21 day) cycle.
16412723|NCT04890093|Drug|Vincristine|Vincristine will be given at a dose of 1.5 mg/m2 by IV on days 1 and 8 of each 21-day cycle.
16412724|NCT04890093|Drug|Temozolomide|and temozolomide will be given at a dose of 100 mg/m2, orally on days 1-5, of each 21 - day cycle
16412725|NCT04888585|Drug|ABBV-154|Subcutaneous Injection
16412726|NCT04888585|Drug|Placebo|Subcutaneous Injection
16412727|NCT04886258|Drug|DFV890|DFV890
16412728|NCT04886258|Drug|Placebo|Placebo
16412729|NCT04886219|Other|Eye examination|"Multimodal fundus imaging (color fundus photography, optical coherence tomography (OCT))
~orthoptic assessment (Visual acuity, Refraction, Cover test, Stereopsis evaluation
~ocular biometry
~corneal topography
~monocular photographs in photopic and scotopic condition"
16412730|NCT04884815|Genetic|UX701|nonreplicating, recombinant gene transfer vector
16412731|NCT04884815|Other|Placebo|normal saline
16412732|NCT04884815|Drug|oral corticosteroids|Participants who receive UX701 (at Baseline or during Stage 3) will receive prophylactic oral corticosteroids.
16412733|NCT04884815|Drug|Placebo for oral corticosteroids|Participants who receive placebo investigational product (IP) will receive placebo oral corticosteroids to maintain the study blind.
16412734|NCT04882124|Drug|CSJ117|CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.
16412735|NCT04882124|Drug|Placebo|Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
16412795|NCT04799301|Behavioral|Diet with no soda|Weight-maintaining diet without soda, with all carbohydrates originating from sources other than corn and sugar cane
16412736|NCT04878367|Behavioral|Five active practices of living rules for responding to fine dust.|"Check the fine dust weather forecast
~Check the operation time and filter of the air purifier
~Window ventilation
~Inhalant is used or not
~Bad fine dust: Refrain from going out"
16412737|NCT04877093|Drug|Clonidine Pill|The study will use a flexible-dose adjustment schedule to identify the minimum dose needed to alleviate symptoms while also ensuring acceptable adverse effects. In other words, all subjects will start at the minimum dose (0.1 mg/night). Near the end of every week, each subject will be assessed for symptom alleviation and adverse events by asking the patient two questions from the CAPS-5 (questions B2 and E6. At baseline, each patient will have scored a ≥3 on each of these questions. If one or both scores remain at ≥3 and if any reported adverse events are marked acceptable by both the clinician and subject, then the dosage for the following week will be increased one level according to the titration chart. However, if both scores for these questions are ≤2 and any current adverse events are acceptable, then the dosage will remain the same. Finally, if any adverse events are deemed unacceptable, the clonidine dosage will be reduced to the lowest acceptable daily dosage.
16412738|NCT04877093|Other|Placebo|Blinded placebo capsules will be provided to participants.
16412739|NCT04876365|Other|Non-Interventional|This is a Non-Interventional Study.
16412740|NCT04870606|Drug|Proxalutamide (GT0918)|Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
16412741|NCT04870606|Drug|Placebo|Placebo+Standard of care determined by PI and local regulatory
16412742|NCT04870281|Device|CRT-DX|Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
16412743|NCT04868292|Drug|SPR206|Three 100 mg SPR206 intravenous doses administered every 8 hours
16412744|NCT04866810|Behavioral|Intervention Arm|High fiber, plant based diet + exercise prescription with ACT sessions
16412745|NCT04866810|Behavioral|Control|Standard diet and exercise recommendations
16412746|NCT04864561|Biological|VLA2001|whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide 2 vaccinations 28 days apart
16412747|NCT04864561|Biological|AZD1222|2 vaccinations 28 days apart AZD1222 is a recombinant, replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 S surface glycoprotein.
16412748|NCT04864561|Biological|VLA2001 - adolescent part|whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxid 2 vaccinations 28 days apart and with a booster vaccination on day 208. Placebo group will receive VLA2001 on day 208 and following second vaccination 28 days later.
16412749|NCT04864561|Biological|Placebo|2 vaccinations 28 days apart with placebo (PBS buffer based on Dulbecco's PBS media formulation without Calcium and Magnesium )
16412750|NCT04863261|Other|Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App|The CHORUS App has been developed as a tool for clinicians to easily visualize important patient information from their smart phones. Relevant information is electronically distributed and placed within the corresponding module in the CHORUS HCP mobile app for iOS and Android.
16412751|NCT04861870|Behavioral|MenCare+/Bandebereho fathers'/couples' group education|MenCare+/Bandebereho was a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engaged men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focused on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
16412752|NCT04857931|Drug|Colchicine|Patients meeting all inclusion criteria and no exclusion criteria will be randomly assigned to receive either colchicine (0.5mg once daily), colchicine (0.5mg twice daily) or matched placebo (1:1:1 allocation ratio), in addition to standard of care.
16412753|NCT04857931|Drug|Placebo|Patients meeting all inclusion criteria and no exclusion criteria will be randomly assigned to receive either colchicine (0.5mg once daily), colchicine (0.5mg twice daily) or matched placebo (1:1:1 allocation ratio), in addition to standard of care.
16412754|NCT04856566|Drug|Low Marijuana, Hash, THC, or Grass|Cannabis with low amount of THC
16412755|NCT04856566|Drug|High Marijuana, Hash, THC, or Grass|Cannabis with high amount of THC
16412756|NCT04856566|Drug|Placebo|Placebo drug with no THC
16412757|NCT04856566|Drug|0.05 BAC Alcohol|Amount of alcohol when consumed leads to BAC of 0.05
16412758|NCT04856566|Drug|0.08 BAC Alcohol|Amount of alcohol when consumed leads to BAC of 0.08
16412759|NCT04853992|Drug|LEO 152020|LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
16412760|NCT04853992|Drug|LEO 152020 placebo|LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
16412761|NCT04852822|Procedure|Biospecimen Collection|Undergo collection of blood samples
16412762|NCT04852822|Other|Electronic Health Record Review|Medical records are reviewed
16412763|NCT04850794|Behavioral|Decision Support Tool|The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation.
16412764|NCT04847466|Drug|N-803|N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every 4 weeks (1 week after starting treatment with the PDL-1 CAR-NK cells).
16412765|NCT04847466|Drug|Pembrolizumab|Pembrolizumab 400 mg will be administered as a 30-minute IV infusion every 6 weeks. Pembrolizumab will be administered on the same day as the PD-L1 CAR-NK cells.
16412766|NCT04847466|Biological|PD-L1 t-haNK|PD-L1 CAR NK cells (2x109) will be administered by IV infusion over approximately 30 minutes every week. After the week 6 treatment, these cells will be given every 2 weeks.
16412796|NCT04799301|Behavioral|Diet with 50% of carb intake from soda|Weight-maintaining diet with 50% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane
16412767|NCT04846504|Behavioral|MMBFM program with clinician coach support|Clinician-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed.
16412768|NCT04846504|Behavioral|MMBFM program with peer coach support|Peer-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed. Peers will be women with lived experience of perinatal depression who are trained on the coaching protocol.
16412769|NCT04846504|Behavioral|Patient facing strategy intervention arm|Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.
16412770|NCT04846504|Behavioral|Patient facing plus clinic facing strategy intervention arm|Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams, plus recommendation of / referral to the Mindful Mood Balance for Moms study by OB clinicians at the 4 study sites. OB clinicians will choose from printed materials (e.g., flyers, posters in exam rooms and waiting rooms, prescription pads) and electronic medical record prompts (e.g., smart lists, dot phrases) to facilitate engagement in the Mindful Mood Balance for Moms course. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.
16412771|NCT04843319|Drug|VERU-100|GnRH antagonist
16412772|NCT04840147|Device|JointRep®|JointRep® is a medical device based on a thermogel polymer (Chitosan) for the treatment of chondral lesions, which consists of an injectable aqueous composition that forms a solid and sticky hydrogel in situ within cartilage defect(s). JointRep® is composed of an injectable thermo-gelling aqueous composition. It is used in conjunction with a Bone Marrow Stimulation type of procedure like Microfracture.
16412773|NCT04840147|Procedure|Microfracture|Microfracture is a bone marrow stimulation type of procedure where after debridement of the damaged chondral tissue within the lesion, obtention of stable vertical margins and curettage of the entire calcified layer, multiple holes are created with a variety of instruments (awls, picks, microdills, nanofracture) to establish a communication with the subchondral bone to create a blood clot to elicit the natural healing process
16412774|NCT04836832|Drug|Acalabrutinib|Given PO
16412775|NCT04836832|Drug|Duvelisib|Given PO
16412776|NCT04834414|Biological|Cold Stored Platelets|Platelets stored at 1-6 degree Celsius
16412777|NCT04834414|Biological|Room Temperature Platelets|Platelets stored at 20-24 degrees Celsius
16412778|NCT04826354|Drug|Rosuvastatin and Ezetimibe|Rosuvastatin Versus Rosuvastatin plus Ezetimibe
16412779|NCT04826354|Drug|Rosuvastatin|Rosuvastatin
16412780|NCT04825704|Drug|Bupivacaine|Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
16412781|NCT04825704|Drug|Sodium chloride|Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
16412782|NCT04825483|Other|Weight loss|"Participants will receive resources to support the weight loss program including a recipe book, activities book and how-to guide. The diet program comprises two phases: 1) intensive weight loss through a ketogenic Very Low Calorie Diet (VLCD), including meal replacements for two meals/day, and 2) transition from ketogenic VLCD onto a longer-term eating plan for weight maintenance. Meal replacements will be provided free of charge for up to 6 months. Participants will be encouraged to lose at least 10% body weight."
16412783|NCT04825483|Other|Exercise|"Participants will receive resources to facilitate the physiotherapy management plan, including information about the video-conference platform, osteoarthritis information, an exercise plan/log book and a booklet of possible exercises. The physiotherapist consultations include a structured, progressive exercise and physical activity plan. Participants will be given exercise resistance bands and a ankle weight for home exercises.
~Physiotherapists will choose from a list of exercises, aiming to prescribe 5-6 at once. Intensity is determined using a modified Rating of Perceived Exertion (RPE) scale, where it should feel hard to very hard to perform a full set of each exercises. Participants are encouraged to complete exercises three times per week. Physiotherapists encourage the participant to increase their general and incidental levels of physical/aerobic activity based on their individual needs and goals, as well as their current level of activity."
16412784|NCT04820309|Drug|Xanomeline and Trospium Chloride Capsules|Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
16412785|NCT04817254|Drug|TMZ|150 mg/m2 on days 1-5 of cycles 1-6
16412786|NCT04817254|Drug|ipilimumab 3mg/kg|3 mg/kg q 4 weeks for cycles 1-4
16412787|NCT04817254|Drug|Nivolumab|1 mg/kg IV q2weeks for cycles 1-4, then 480 mg q 4 weeks for cycles 5-16
16412788|NCT04817254|Drug|ipilimumab 1mg/kg|1 mg/kg q 4 weeks for cycles 1-4
16412789|NCT04815720|Drug|pepinemab + pembrolizumab|The Safety Run-in phase will begin at 20 mg/kg pepinemab with a fixed dose of 200 mg pembrolizumab. The dose of pepinemab may be reduced to 15 mg/kg or 10 mg/kg with a fixed dose of 200 mg pembrolizumab if the initial pepinemab dose of 20 mg/kg is found to not be well tolerated. Once a recommended phase II dose of pepinemab is determined it will be utilized in the Dose Expansion phase in combination with 200 mg pembrolizumab.
16412790|NCT04815356|Biological|CD22CART cell infusion|The treatment regimen will consist of lymphodepleting chemotherapy followed by CD22CART infusion: Days -4 to -2: fludarabine 25 mg/m2/dose Day -2: cyclophosphamide 900 mg/m2/dose Day 0: CD22CART infusion (starting at dose level 1 [DL1]: 1 x 105 transduced CAR-T cells/kg) on Day 0 Subjects will be evaluated for response at Day 28 post-CD22CART infusion.
16412791|NCT04808427|Device|TULSA-PRO|Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate
16412792|NCT04807387|Device|Vaginal Stent A|Ring stent
16412793|NCT04807387|Device|Vaginal Stent B|Flower stent
16412797|NCT04799301|Behavioral|Diet with 20% of carb intake from soda|Weight-maintaining diet with 20% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane
16412798|NCT04794699|Drug|IDE397|Small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A)
16412799|NCT04789174|Drug|Solriamfetol|Solriamfetol 75 mg/d Solriamfetol 150 mg/d
16412800|NCT04789174|Drug|Placebo|Placebo
16412801|NCT04787302|Drug|CVL-231|Cohort 1: 30mg dose of CVL-231
16412802|NCT04787302|Drug|CVL-231|Cohort 2: CVL-231 dose to be decided based on results of Cohort 1 or trial may be concluded
16412803|NCT04787302|Drug|CVL-231|Cohort 3: CVL-231 dose to be decided based on results of Cohorts 1 and/or 2
16412804|NCT04774523|Procedure|Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.|"Patients in the AutoAdapt group undergo the echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.
~Three steps must be followed:
~Standard AV programming: perform echo for AoVTI assessment.
~Echo-optimized AV programming: perform standard echo-based AV-optimization (Ritter method or iterative method, according to routine at investigational site); measure AoVTI at optimized setting.
~AutoAdapt optimized programming: The system allows different programming options for the parameter 'Adaptive AV reduction'. The nominal value is 0.7, but it can be modified to different values ranging from 0.5 to 0.9. The AoVTI shall be measured at three settings of the Adaptive Av reduction parameter: at standard setting, at 0.5 and at 0.9."
16412805|NCT04774523|Procedure|Echocardiography AV optimization|Patient in the control group undergo the routine echo based AV-optimization that is usually performed at the investigational site (Ritter method23 or iterative method23). Performance of an additional VV-delay optimization is left to the investigators discretion
16412806|NCT04774523|Procedure|Echocardiography|Echocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V)
16412807|NCT04774523|Other|Self Assessment Score|Patient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score
16412808|NCT04774497|Other|Oxygen inhalation treatment group|Oxygen inhalation group: oxygen inhalation was started on the first day of chemotherapy, and the oxygen inhalation volume was 2 L / min, 8 hours / day for 3 consecutive days.
16412809|NCT04774497|Other|Control group|The control group was not given oxygen inhalation.
16412810|NCT04770493|Drug|Lamotrigine|Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills).
16412811|NCT04770493|Drug|Placebo|Matching placebo (sugar pill)
16412812|NCT04770220|Drug|Experimental: ALZ-801|ALZ-801 tablet 265 mg BID
16412813|NCT04770220|Drug|Placebo Comparator: Placebo|Placebo tablet BID
16412814|NCT04765566|Device|Endovascular revascularization of peripheral arteries|Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments
16412815|NCT04763356|Other|Symptom Care at Home with NP follow up|In the SCH-NP group all participants will report their CIPN related symptoms daily via the app, website or phone tree. Any moderate to severe symptoms will trigger a call back from a nurse practitioner who will use a consensus and evidence based algorithm to prescribe therapies for the CIPN symptoms.
16412816|NCT04762069|Drug|Berubicin|Berubicin HCl is a novel synthetic anthracycline with a chemical structure similar to doxorubicin HCl, a cytotoxic anthracycline topoisomerase II inhibitor isolated from cultures of Streptomyces peucetius var. caesius.
16412817|NCT04762069|Drug|Lomustine|"Lomustine is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. This medication is classified as an alkylating agent."
16412818|NCT04759586|Drug|Cyclophosphamide|Given IV
16412819|NCT04759586|Drug|Doxorubicin Hydrochloride|Given IV
16412820|NCT04759586|Drug|Etoposide Phosphate|Given IV
16412821|NCT04759586|Biological|Filgrastim|Given SC
16412822|NCT04759586|Biological|Nivolumab|Given IV
16412823|NCT04759586|Biological|Pegfilgrastim|Given SC
16412824|NCT04759586|Drug|Prednisolone|Given PO
16412825|NCT04759586|Drug|Prednisone|Given PO
16412826|NCT04759586|Radiation|Radiation Therapy|Undergo radiation therapy
16412827|NCT04759586|Biological|Rituximab|Given IV
16412828|NCT04759586|Biological|Rituximab and Hyaluronidase Human|Given SC
16412829|NCT04759586|Drug|Vincristine Sulfate|Given IV
16412830|NCT04750928|Drug|Abemaciclib|Abemaciclib is to be administered orally on Days 1 through 28 of each 28-day cycle
16412831|NCT04742400|Drug|tolebrutinib|orally x 96 weeks
16412832|NCT04740827|Drug|Atogepant 60 mg|Tablets containing 60 mg of Atogepant
16412833|NCT04740827|Drug|Placebo|60mg tablets containing Atogepant matching placebo
16412834|NCT04739059|Biological|CSL312|Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
16412835|NCT04736121|Device|Resin microspheres containing yttrium-90 (Y-90)|Biocompatible resin microspheres are an injectable permanent implant and preferentially placed into the distal microvascular supply of tumors to provide direct irradiation of tissue and destruction of the microvascular bed. Spheres contain yttrium-90 (Y-90) and are a size between 20 and 60 microns in diameter.
16412836|NCT04733040|Drug|MOR202|5 or 2 doses of MOR202 will be administered as an intravenous infusion
16412837|NCT04732117|Drug|Secukinumab|Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4.
16412838|NCT04732117|Drug|Placebo|Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4.
16412839|NCT04731974|Drug|Melatonin 5 mg|Participants in the melatonin group will be instructed to take 1 5-mg melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.
16412840|NCT04730232|Drug|Tislelizumab|Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.
16412841|NCT04730232|Drug|Nab-paclitaxel|Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
16412842|NCT04721353|Drug|Prazosin Hydrochloride|prazosin hydrochloride oral 1-25 mg/day
16412843|NCT04711902|Drug|Secukinumab (AIN457)|Biological
16412844|NCT04711902|Other|Secukinumab Placebo|Matching placebo
16412845|NCT04711252|Drug|AZD9833|Dosage formulation: AZD9833 tablets will be administered orally
16412847|NCT04711252|Drug|Anastrozole placebo|Dosage formulation: anastrozole placebo tablets will be administrated orally.
16412848|NCT04711252|Drug|AZD9833 placebo|Dosage formulation: AZD9833 placebo tablets will be administrated orally.
16412849|NCT04711252|Drug|Palbociclib|Dosage formulation: palbociclib tablets/capsules will be administered orally
16412850|NCT04711252|Drug|Luteinizing hormone-releasing hormone (LHRH) agonist|Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
16412851|NCT04710576|Drug|axatilimab|Axatilimab (SNDX-6352) is a high-affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.
16412852|NCT04707885|Device|Electrocochleography|"The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component.
~For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions."
16412853|NCT04707300|Drug|Human T Lymphoid Progenitor (HTLP) injection|The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0
16412854|NCT04703166|Device|Samsung Galaxy Watch Active2|The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.
16412855|NCT04701918|Drug|Pembrolizumab|Intravenous injection through a vein (IV) every 3 weeks
16412856|NCT04701918|Procedure|Cryoablation|Needle inserted through the skin and into the tumor using CT guidance
16412857|NCT04699032|Drug|Apraglutide|Single dose of apraglutide 5 mg.
16412858|NCT04696055|Drug|Pembrolizumab|Pembrolizumab 400 mg to be administered as an intravenous (IV) infusion every 6 weeks (Q6W).
16412859|NCT04696055|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib will be given orally (p.o.) at a starting dose of 90 mg QD for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily is well tolerated the dose should be escalated to 120 mg starting after the first 4-week cycle of regorafenib.
16412860|NCT04692675|Diagnostic Test|mpMRI|3T endorectal coil MR imaging of the prostate gland
16412861|NCT04689828|Radiation|177Lu-PSMA-617|administered intravenously once every 6 weeks (1 cycle) for 6 cycles
16412862|NCT04689828|Radiation|68Ga-PSMA-11|single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi).
16412863|NCT04689828|Drug|ARDT|administered orally on a continuous basis, as per package insert and guidelines
16412864|NCT04689828|Other|Best supportive care|Best supportive/best standard of care as defined by the local investigator
16412865|NCT04686136|Drug|Atogepant 60 mg|Tablets containing 60 mg of Atogepant
16412866|NCT04683055|Procedure|Phacoemulsification combined with trabeculectomy|Patients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision
16412867|NCT04683055|Procedure|Phacoemulsificaiton combined with ab-externo trabeculotomy|Patients with chronic angle closure glaucoma assigned to this group will have Deep Sclerectomy with ab externo trabeculotomy at superior limbus and then phacoemulsification via temporal incision
16412868|NCT04681066|Drug|CM-4620 Injectable Emulsion or CM-4620-IE|Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
16412869|NCT04681066|Other|Placebo|Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.
16412870|NCT04679870|Drug|GB2064|GB2064 (formerly PAT-1251) is a high-affinity, selective, mechanism-based, small molecule inhibitor of LOXL2, administered twice a day
16412871|NCT04676854|Device|PRIMA Bionic Vision System|Implantation of PRIMA, Vision training, follow up
16412872|NCT04671017|Biological|VLA2001|whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide
16412873|NCT04668391|Procedure|Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament|Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.
16412874|NCT04668391|Procedure|Thoracic epidural analgesia|A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.
16412875|NCT04667481|Other|Aerobic Exercise Intervention|Participate in aerobic exercise intervention
16412876|NCT04667481|Other|Resistance Exercise Intervention|Participate in resistance exercise intervention
16412877|NCT04667481|Other|Exercise Intervention: Digital copies and outline of sessions|Receive digital copy of AE and RE sessions and an outline of sessions
16412878|NCT04667481|Other|Questionnaire Administration|Ancillary studies
16412879|NCT04667481|Other|Quality-of-Life Assessment|Ancillary studies
16412880|NCT04663282|Drug|INS068 injection|INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
16412881|NCT04663282|Drug|Insulin Degludec|Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
16412882|NCT04661150|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 3 cycles prior to surgery and 5 cycles after surgery.
16413148|NCT04269213|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
16412883|NCT04661150|Drug|Trastuzumab|Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.
16412884|NCT04661150|Drug|Capecitabine|Capecitabine 1000 mg/m^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.
16412885|NCT04661150|Drug|Oxaliplatin|Oxaliplatin 130 mg/m^2 will be administered by IV on Day 1 of a 21-day cycle.
16412886|NCT04660344|Drug|Atezolizumab|Participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
16412887|NCT04660344|Other|Placebo|Participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle
16412888|NCT04659174|Drug|Xanomeline and Trospium Chloride Capsules|Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
16412889|NCT04658277|Drug|Clarithromycin|Patients in the intervention arm will take Clarithromycin 250mg daily.
16412890|NCT04658277|Other|Usual care|Patients will receive usual medical care
16412891|NCT04658186|Drug|UCB0599|Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
16412892|NCT04658186|Drug|Placebo|Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.
16412893|NCT04652726|Drug|Inclisiran|Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection
16412894|NCT04652726|Drug|Placebo|Sterile normal saline (0.9% sodium chloride in water for subcutaneous injection)
16412895|NCT04650633|Drug|SHR-1701|Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
16412896|NCT04648085|Device|Transcutaneous Electric Stimulation|Applied to to the forehead using a self-adhesive electrode positioned bilaterally over the upper branches of the trigeminal nerve.The device generates electrical impulses allowing to stimulate the trigeminal nerve.
16412897|NCT04645953|Combination Product|3mg AZ-010|Subject will receive a single inhaled dose (3mg)
16412898|NCT04645953|Combination Product|1mg AZ010|Subject will receive a single inhaled dose (1mg)
16412899|NCT04645953|Combination Product|Staccato Placebo|Subject will receive a single inhaled dose (Staccato Placebo)
16412900|NCT04645160|Drug|Tivozanib|Oral tivozanib taken daily for Days 1-21 continuously (of each 28-day cycle) followed with 7 days off medication (except for patients in DL-1, with dosing every other day of the 28-day cycle). Phase I: The starting dose (DL1) is 0.89 mg taken once a day continuously for Days 1-21 with 1 week off medication (except for those patients assigned to DL-1, where tivozanib should be taken every other day, around 48 hours apart in 28-day cycle). Patients may escalate to 1.34 mg taken once a day (DL2) continuously for Days 1-21 with 1 week off medication for their second cycle if there are no dose-limiting toxicities. Phase II: Tivozanib dose level will be at the recommended Phase II dose (RP2D) established in Phase I.
16412901|NCT04645147|Biological|EBV gp350-Ferritin Vaccine|A 50 micrograms dose of EBV gp350-Ferritin vaccine will be administered intramuscularly for each vaccination at Days 0, 30, and 180 to all participants.
16412902|NCT04645147|Other|Matrix-M1|Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1.
16412903|NCT04640077|Other|No Intervention|No intervention
16412904|NCT04640077|Drug|donanemab|Administered IV
16412905|NCT04639843|Drug|CC-486 (5-azacitidine)|CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 8 cycles.
16412906|NCT04639843|Drug|Duvelisib|Duvelisib by oral intake at escalating doses of 25, 50 and 75 mg/BID on days -14 to 14 of the 1st cycle then days 1-14 of Cycles 2-8 of each 21- day cycle (max 8 cycles).
16412907|NCT04639843|Drug|Romidepsin|Romidepsin (12mg/m2) will be administered on days 1 and 8 of each cycle through a peripheral or central intravenous catheter for 8 cycles.
16412908|NCT04639843|Drug|Doxorubicin|Doxorubicin at 25 mg/ m2 by IV infusion on Day 1 of cycles 3-8.
16412909|NCT04637763|Genetic|CB-010|CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
16412910|NCT04637763|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
16412911|NCT04637763|Drug|Fludarabine|Chemotherapy for lymphodepletion
16412912|NCT04632992|Drug|Entrectinib|Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
16412913|NCT04632992|Drug|Inavolisib|Inavolisib will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.
16412914|NCT04632992|Drug|Alectinib|Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.
16412915|NCT04632992|Drug|Ipatasertib|Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.
16412916|NCT04632992|Drug|Atezolizumab|Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
16412917|NCT04632992|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
16413149|NCT04268823|Drug|QBW251|Capsule 450mg
16412918|NCT04632992|Drug|Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf|PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
16412919|NCT04632992|Drug|Tucatinib|Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
16412920|NCT04632992|Drug|Investigator's Choice of Chemotherapy|Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines.
16412921|NCT04632992|Drug|Paclitaxel|The dose of paclitaxel is 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. The paclitaxel infusion will be delivered over at least 60 minutes for each dose per institutional guidelines and administered after the oral dose of ipatasertib.
16412922|NCT04632992|Drug|Tiragolumab|Following the administration of atezolizumab and an observation period, participants will receive 600 mg tiragolumab at a fixed dose administered by IV infusion on Day 1 of each 21-day cycle.
16412923|NCT04632992|Drug|Pralsetinib|Pralsetinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg/day (four 100-mg capsules per day) once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
16412924|NCT04625270|Drug|VS-6766|VS-6766 Monotherapy
16412925|NCT04625270|Drug|VS-6766 and Defactinib|VS-6766 and Defactinib Combination
16412926|NCT04621071|Dietary Supplement|Probiotics (2 strains 10x10^9 UFC)|Probiotic vs Placebo (1:1)
16412927|NCT04621071|Dietary Supplement|Placebo (potato starch and magnesium stearate)|Probiotic vs Placebo (1:1)
16412928|NCT04620733|Drug|Seladelpar 10 mg|Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months
16412929|NCT04620733|Drug|Placebo|One capsule daily for double-blind period, for a duration of up to 12 months
16412930|NCT04620733|Drug|Seladelpar 5 mg|If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months
16412931|NCT04616417|Procedure|Investigational Oocyte Cryopreservation|Transvaginal oocyte retrieval under ultrasound guidance
16412932|NCT04613089|Other|Natural History|Natural History and Clinical Follow Up.
16412933|NCT04610346|Behavioral|Persons with Aphasia Training Dogs Program|Participants will learn and apply positive reinforcement training techniques for working with dogs to train them in basic obedience behaviors (e.g., SIT, STAY).
16412934|NCT04609046|Drug|Lenalidomide|Given PO
16412935|NCT04609046|Drug|Methotrexate|Given IV or PO
16412936|NCT04609046|Biological|Nivolumab|Given IV
16412937|NCT04609046|Biological|Rituximab|Given IV
16412938|NCT04603157|Behavioral|Hybrid Exercise Training|Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months
16412939|NCT04602117|Drug|Vic-trastuzumab duocarmazine (SYD985) + paclitaxel|"SYD985 ([vic-]trastuzumab duocarmazine) an antibody-drug conjugate or ADC being developed by Byondis B.V. (Nijmegen, The Netherlands), consists of the recombinant humanized anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab linked, via a cleavable linker, to the duocarmycin prodrug, seco-duocarmycin-hydroxybenzamide-azaindole or seco-DUBA, which has potent antineoplastic activity.
~Eligible patients will receive infusions of SYD985 every three weeks and of paclitaxel weekly."
16412940|NCT04601051|Biological|NTLA-2001|A clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 gene editing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
16412941|NCT04599634|Drug|Obinutuzumab|Administered intravenously, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase. For expansion phase, administered on Days 1, 2, 8 and 15 of Cycle 2 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg.
16412942|NCT04599634|Drug|Venetoclax|For FL patients in dose finding phase, administered orally at a dose of 600mg or 800mg depending on tolerance, daily, cycles 1-12. For MZL, MCL or CLL patients in dose finding phase administered at an escalating dose from 20mg-400mg Cycle 1 on days 1-35, and at a dose of 400mg per day for Cycles 2-12. Patients in expansion phase will receive target dose established from dose finding cohorts daily for all 12 cycles.
16412943|NCT04599634|Drug|Magrolimab|Administered intravenously, starting at 1 mg/kg on second day of first cycle then 30mg/kg on days 8, 15 and 22 of cycle 1 and days 1 and 15 of cycles 2-12 for patients in both the dose finding and expansion phases.
16412944|NCT04597918|Drug|Faricimab|A 6-milligram (mg) dose of faricimab will be administered intravitreally (IVT) in the study eye once every 4 weeks (Q4W).
16412945|NCT04594369|Drug|Brensocatib 10 mg|Oral tablet.
16412946|NCT04594369|Drug|Brensocatib 25 mg|Oral tablet.
16412947|NCT04594369|Drug|Placebo|Brensocatib-matching oral tablet.
16412948|NCT04593927|Drug|Mayzent|There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.
16412949|NCT04590963|Drug|Monalizumab|Monalizumab (intravenous)
16412950|NCT04590963|Drug|Cetuximab|Cetuximab (intravenous)
16412951|NCT04590872|Biological|Tolerogenic Dendritic Cell Vaccine|PIpepTolDCs
16412952|NCT04586049|Device|MRI|Participants will undergo an MRI scan while participating in a breathing test to measure brain blood flow.
16412953|NCT04586049|Device|Transcranial Doppler Ultrasound|Participants will undergo a TCD scan while participating in a breathing test to measure brain blood flow.
16412954|NCT04586049|Other|Sympathetic Nerve Activity|Participants will undergo sympathetic nerve activity testing while participating in a breathing test.
16412955|NCT04583878|Diagnostic Test|Blood draw (Visit 1)|Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
16412956|NCT04583878|Diagnostic Test|Blood draw (Visits 2 and 3)|Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.
16413150|NCT04268823|Drug|Placebo|Capsule 450mg
16413151|NCT04265911|Biological|ASP3772 (subcutaneous)|Subcutaneous injection
16413152|NCT04265911|Biological|ASP3772 (intramuscular)|Intramuscular injection
16412957|NCT04579367|Drug|Bempedoic acid and/or its fixed-dose combination with ezetimibe|This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.
16412958|NCT04576377|Biological|FluBlok|Recombinant HA quadrivalent influenza vaccine (0.5mL Flublok®, Sanofi Pasteur) containing 180μg antigen, 45μg for each influenza strain included.
16412959|NCT04576377|Other|Placebo|0.5mL saline placebo.
16412960|NCT04573322|Drug|Trans Sodium Crocetinate|TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
16412961|NCT04573322|Drug|Normal saline|Normal Saline, in an equivalent volume by participant body weight, administered via IV bolus every 6 hours for up to 15 days
16412962|NCT04569799|Drug|Lumason|2.4 mL per lesion
16412963|NCT04569591|Drug|Acthrel|Intravenous administration of ovine CRH (Acthrel (Registered Trademark) 1 mcg/kg up to a maximum dose of 100 mcg) results in selective increase in ACTH activity of pituitary adenomas within two minutes and peaks between 10-15 minutes.
16412964|NCT04569084|Drug|MT-1186|Oral edaravone
16412965|NCT04569084|Drug|Placebo|Oral
16412966|NCT04566133|Drug|Trametinib|orally 2 mg once a day
16412967|NCT04566133|Drug|Hydroxychloroquine|orally 600 mg twice a day - 1,200 mg total dose
16412968|NCT04565288|Drug|Atomoxetine|Participants randomized to receive the study medication, atomoxetine (brand name: Straterra) for 6-weeks (40 mg/day for 3 days then 80 mg/day thereafter). A comparator group will receive placebo (sugar pills).
16412969|NCT04565288|Drug|Placebo|Matching placebo (sugar pill)
16412970|NCT04564755|Drug|abrocitinib|Participants will receive abrocitinib 100 mg or 200 mg orally once a day as directed by the investigator's clinical judgement
16412971|NCT04562090|Drug|mirabegron|Mirabegron will be administered as single oral dose of 25 mg or 50 mg sustained-release tablet
16412972|NCT04561388|Procedure|Electrocochleography|"Electrocochleographic responses will be evoked using different pure tone sounds delivered through an insert placed in the external auditory duct. The responses will be recorded with the electrodes of the cochlear implant connected to a dedicated interface.
~Electrocochleographic responses will be collected continuously during the electrode-array insertion at the implantation surgery using 500Hz pure tone and after suturing with 250, 500, 750 and 1000Hz pure tones. Then, electrocochleographic responses to pure tones from 125 to 8000HZ (according to the subject residual hearing) will be recorded 2 weeks, 1 month, 2 months and 4 months after implantation."
16412973|NCT04561388|Other|Pure Tone Audiometry|"The perception thresholds to 125, 250, 500, 750, 1000, 2000, 4000 and 8000 Hz pure tones will be measured within the month preceding the implantation using the same insert t.
~Pure tone audiometry with the same frequencies will be done 2 weeks, 1, 2 and 4 months after the implantation."
16412974|NCT04561388|Other|Speech audiometry|The speech perception will be assessed in silence and in noise in free field 1 and 4 months after implantation. The speech perception in silence will be assessed using monosyllabic words 60 dB SPL. Speech in noise will be assessed using an adaptative test with fixed noise level (60 dB SPL).
16412975|NCT04559126|Drug|EDP-297|EDP-297 Oral solution
16412976|NCT04559126|Drug|Placebo|placebo to match EDP-297
16412977|NCT04550260|Drug|Durvalumab|Durvalumab intravenous infusion
16412978|NCT04550260|Drug|Placebo|Durvalumab matching placebo for intravenous infusion
16412979|NCT04550260|Drug|cisplatin + fluorouracil|cisplatin + fluorouracil, as per Standard of Care
16412980|NCT04550260|Drug|cisplatin + capecitabine|cisplatin + capecitabine, as per Standard of Care
16412981|NCT04550260|Radiation|Radiation|50-64Gy in total
16412982|NCT04549103|Other|Baduanjin exercise program|Baduanjin (BDJ), also known as Eight-Section Brocades, is one of the forms of traditional Chinese Qigong exercises, characterized by symmetrical physical posture, movements, mindfulness, and breathing. Its primary focus is on the release of 'Qi' or internal body energy with the intent of improving health outcomes. BDJ encompasses eight simple movements involving combinations of postures, meditation, slow relaxing movements, and breathing exercises. It is a low intensity exercise, which have been found to improve range of motion, strength and general health. The simplicity and low intensity level is ideal for older adults to practice at home using instructional videos.
16412983|NCT04548752|Drug|Olaparib|Given PO
16412984|NCT04548752|Biological|Pembrolizumab|Given IV
16412985|NCT04544410|Drug|Tildacerfont/Placebo|Tablet, administered daily
16412986|NCT04541212|Diagnostic Test|Cardiac Imaging|Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test
16412987|NCT04541212|Other|Data Collection|Collection of retrospective data
16412988|NCT04540848|Drug|Group A (Exparel plus supraclavicular block)|"Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket."
16412989|NCT04540848|Drug|Group B (Bupivacaine HCL plus supraclavicular block)|"Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket."
16412990|NCT04540848|Drug|Group C(supraclavicular block only)|"In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket."
16412991|NCT04539236|Drug|Lenalidomide|Administered daily by mouth on a 21 day cycle. Doses will be administered at 2.5 mg, 5 mg and 10 mg.
16412992|NCT04539236|Drug|Luspatercept|Administered subcutaneously in the upper arm, thigh and/or abdomen on Day 1 of a 21 day cycle. Starting dose will be at 1.0 mg/kg and can be titrated, dependent on participant response, to doses of 1.33 mg/kg, and 1.75 mg/kg.
16412993|NCT04535414|Device|Cellvizio (Registered trademark) 100 microscope|Subjects in Arm 2 will additionally undergo confocal imaging with contrast following the Cambridge method.
16412994|NCT04535414|Device|Olympus GIF 180 endoscope|Participants will undergo white light endoscopy. The mucosa of the stomach will be thoroughly washed before examination and inspection will include repeated inflation and deflation to check distensibility and any abnormal appearing areas will additionally be biopsied. Non-targeted biopsies will be obtained as indicated per the assigned Arm.
16412995|NCT04531592|Drug|Valproic acid|Valproate sodium in 5-ml single-dose vials containing 100 mg/ml of VPA. The appropriate dose of 140 mg/kg, based on the subject's weight at study entry, will be diluted in isotonic saline solution to a final volume of 300 ml for administration
16412996|NCT04531592|Drug|Isotonic saline solution|Isotonic saline solution consisting of 0.9% sodium chloride in the volume of 300 ml for administration
16412997|NCT04531579|Drug|Valproic Acid Solution|Valproate sodium in 5-ml single-dose vials containing 100 mg/ml of VPA. The appropriate dose of 140 mg/kg, based on the subject's weight at study entry, will be diluted in isotonic saline solution to a final volume of 300 ml for administration
16412998|NCT04531579|Drug|Isotonic saline solution|Isotonic saline solution consisting of 0.9% sodium chloride in the volume of 300 ml for administration
16412999|NCT04525599|Biological|ASP3772|Intramuscular (IM) injection
16413000|NCT04525599|Biological|PCV13|Intramuscular injection
16413001|NCT04517357|Drug|Fluzoparib+Apatinib|Fluzoparib-Apatinib combination
16413002|NCT04517357|Drug|Fluzoparib|Fluzoparib monotherapy
16413003|NCT04517357|Drug|Fluzoparib+Apatinib|Fluzoparib-Apatinib combination
16413004|NCT04515849|Drug|Cotadutide 100 micrograms|Cotadutide 100 micrograms administered subcutaneously
16413005|NCT04515849|Drug|Cotadutide 300 micrograms|Cotadutide 300 micrograms administered subcutaneously
16413006|NCT04515849|Drug|Cotadutide 600 micrograms|Cotadutide 600 micrograms administered subcutaneously
16413007|NCT04515849|Drug|Semaglutide|Semaglutide 1.0 miligrams administered subcutaneously
16413008|NCT04515849|Drug|Placebo|Placebo administered subcutaneously
16413009|NCT04510584|Drug|Atezolizumab|Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.
16413010|NCT04510584|Drug|Bevacizumab|Bevacizumab is a recombinant humanized IgG1 monoclonal antibody that binds VEGF, a secreted factor that stimulates angiogenesis. Bevacizumab prevents the interaction of VEGF with its receptors and neutralizes the biological activity of VEGF.
16413011|NCT04509427|Behavioral|Instructional handouts|Handouts will include written instructions for each aspect of the multifaceted exercise/posture training program
16413012|NCT04509427|Behavioral|Physical therapist instruction and monitoring via teleconferencing|The intervention physical therapist (PT) meets with them via Zoom for 60 minutes to help them start the program in the first week. This PT will meet with them again in week 2 to complete initial instructions. The PT will meet with them week 3 and then every other week for 15-minutes to help individuals safely progress the program.
16413013|NCT04509427|Behavioral|Web-based instructional videos|Instructional videos that will lead participants through every part of the intervention - like a commercial exercise video.
16413014|NCT04509427|Behavioral|Posture training|Participants will learn how to hold a neutral spine posture during sitting, forward leaning in sitting, sit-to-stand-to-sit, standing, forward leaning in standing, supine-to-sit-to-supine, supine-to-prone-to-supine, and lifting. Principles learned with these functional movement patterns will then be put to practice in common tasks like sweeping, washing dishes, dusting, and gardening. This will be taught over two sessions in the first two weeks of the program. To reinforce holding neutral spine with all activities, participants will perform a 5-minute posture warm-up routine prior to exercising.
16413015|NCT04509427|Behavioral|Marching in place|Participants will perform marching in place five times a week. Participants will be instructed to slowly progress to a goal of performing 30 minutes of marching in place per session. They will be instructed to lift their knees to a height that is between their waist and knee when marching. They will be instructed to march between a rating of 10 -14 on the 20-point Borg scale for rate of perceived exertion
16413016|NCT04505774|Drug|theraputic heparin|increased dose of heparin above standard of care.
16413017|NCT04505774|Drug|prophylactic heparin|standard of care dose of heparin
16413018|NCT04505774|Drug|P2Y12|added P2Y12 inhibitor
16413019|NCT04505774|Drug|Crizanlizumab Injection|crizanlizumab injection
16413020|NCT04505774|Drug|SGLT2 inhibitor|sglt2 inhibitor
16413021|NCT04501640|Drug|mirabegron|Oral adminstration
16413022|NCT04495751|Dietary Supplement|Muscadine grape extract|Four pills twice daily
16413023|NCT04495751|Drug|Placebo|Four pills twice daily.
16413024|NCT04495751|Other|Quality of Life Assessment|Ancillary studies
16413025|NCT04495751|Other|Questionnaires|Ancillary studies
16413026|NCT04494113|Procedure|Biospecimen Collection|Undergo tissue collection
16413027|NCT04494113|Procedure|Resection|Undergo surgical resection
16413028|NCT04494113|Drug|Triapine|Given IV
16413029|NCT04486859|Drug|LMWH/Rivaroxaban|combined prevention
16413030|NCT04486859|Device|IPC|mechanical prevention
16413031|NCT04484935|Drug|Nirsevimab|Single fixed IM dose of nirsevimab 50 mg if body weight < 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
16413032|NCT04483115|Drug|TPN171H|Tablets; Oral; Single dose
16413033|NCT04483115|Drug|Placebo|Tablets; Oral; Single dose
16413034|NCT04483115|Drug|Tadalafil|Tablets; Oral; Single dose
16413035|NCT04474795|Behavioral|Usual Care + Community health worker delivered patient education curriculum|Patient participants will receive usual care from trained health center staff. They will also receive 4 education sessions during pregnancy and 3 sessions postpartum with a trained community health worker.
16413036|NCT04474795|Behavioral|Usual Care|Patients receive usual care from trained health center staff. Note that his arm has changed and is not being actively recruited. Outcomes from eligible non-participants in the intervention will be compared to intervention participants from the same time period. Usual care group will be identified retrospectively via partial HIPAA waiver.
16413153|NCT04265911|Biological|PPSV23 (subcutaneous)|Subcutaneous injection
16413037|NCT04474795|Behavioral|Staff -Educational training|Nurses and community health workers will complete 4 hours of online modules on gestational diabetes - Module 1: GDM Disease, Diagnosis and Complications; Module 2: Nutrition and Physical Activity Management; Module 3: Monitoring, Medications, and Avoiding Hypoglycemia; Module 4: Future Diabetes Risk and Prevention. Effectiveness of the training will be evaluated with pre/post evaluation of diabetes knowledge, attitudes, and self efficacy.
16413038|NCT04472338|Procedure|Biospecimen Collection|Undergo collection of blood, urine, and/or tissue samples
16413039|NCT04472338|Other|Laboratory Biomarker Analysis|Correlative studies
16413040|NCT04472338|Other|Quality-of-Life Assessment|Ancillary studies
16413041|NCT04472338|Other|Questionnaire Administration|Ancillary studies
16413042|NCT04469764|Drug|Abemaciclib|Given PO
16413043|NCT04469764|Drug|Anastrozole|Given PO
16413044|NCT04469764|Drug|Letrozole|Given PO
16413045|NCT04469205|Other|Coaching sessions|There are 3 sessions : the first session will last 1h30 and will be in consultation within the Institut Curie. The second and third sessions will last respectively 1h30 and 1h and will be done remotely (by phone).
16413046|NCT04468360|Behavioral|3-day differential fear conditioning, extinction, and extinction retention testing paradigm|Day 1: Fear acquisition involving the pairing of a brief, noxious but not painful air blast to the neck (unconditioned stimulus; US) to a conditioned stimuli (CS) (Expts. 1 and 2). The CS will be different colored shapes appearing on a computer monitor. An auditory stimulus will serve as the startle probe. Day 2: Either extinction training (Expt. 1) or fear memory reactivation by a single CS+ with no US (Expt. 2) will occur followed by IV Allo vs. IV placebo administration. Day 3: The effects of IV Allo vs. IV placebo (administered on Day 2) on extinction retention (Expt. 1) or reconsolidation blockade (Expt. 2), as well as reinstatement of conditioned fear (Expts. 1 and 2) will be assessed.
16413047|NCT04468360|Drug|Allopregnanolone (Allo) with Dexolve in 0.9% saline for injection manufactured by University of California, Davis|Expt. 1 (extinction retention): On Day 2, a 1.7 ug/kg IV bolus of Allo will be administered over 5 minutes at the completion of extinction training and continued as a 5-hour drip to maintain resting plasma Allo levels at ~1500 pg/ml. Expt. 2 (reconsolidation blockade): On Day 2, a 28 ug/kg IV bolus of Allo will be infused over 30 minutes immediately following presentation of a single CS+.
16413048|NCT04468360|Other|Matching IV Placebo|Expt. 1 (extinction retention): On Day 2, a 1.7 ug/kg IV bolus of the matching placebo formulation will be administered over 5 minutes at the completion of extinction training and continued as a 5-hour drip to maintain resting plasma Allo levels at ~1500 pg/ml. Expt. 2 (reconsolidation blockade): On Day 2, a 28 ug/kg IV bolus of the matching placebo formulation will be infused over 30 minutes immediately following presentation of a single CS+.
16413049|NCT04464226|Drug|Darolutamide (Nubeqa, BAY1841788)|Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
16413050|NCT04462146|Behavioral|Internet-based Self Applied Treatment Program|"It is a self-applied treatment for PGD through the web psicologíaytecnología.labpsitec.es. There are 8 treatment modules. Each module lasts approximately 60 minutes. It contains written information, videos, audios, photos and interactive questionnaires. The total duration of treatment is up to 8-10 weeks. A weekly support call will be made (maximum 10 minutes) to answer questions and reinforce and motivate the patient. No additional clinical content or counselling will be provided. Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention"
16413051|NCT04462146|Behavioral|Videoconference treatment with a therapist|"It is a treatment for PGD applied by a therapist composed of 8-10 treatment sessions. Each session lasts approximately 60 minutes. No weekly support call will be provided.
~The sessions will take place by videoconference. Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention."
16413052|NCT04460573|Device|Boot|Smart boot in one of three configurations provided to participants
16413053|NCT04458623|Diagnostic Test|Air Test|.The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
16413054|NCT04458220|Other|photo and voice obtained|The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.
16413055|NCT04457336|Drug|Tildacerfont/Placebo|Tablet, administered daily
16413056|NCT04454658|Drug|ABBV-744|Tablet; Oral
16413057|NCT04454658|Drug|Navitoclax|Tablet; Oral
16413058|NCT04454658|Drug|Ruxolitinib|Tablet; Oral
16413059|NCT04444921|Drug|Carboplatin|Given IV
16413060|NCT04444921|Biological|Nivolumab|Given IV
16413061|NCT04444921|Drug|Paclitaxel|Given IV
16413062|NCT04433858|Drug|Psilocybin|open-label
16413063|NCT04431726|Drug|Emicizumab|"Initially, all participants will receive 4 loading doses of 3 milligrams per kilogram (mg/kg) emicizumab subcutaneously (SC) once every week (QW) for 4 weeks followed by the maintenance dosing regimen 3 mg/kg emicizumab SC once every 2 weeks (Q2W) for a total of 52 weeks. Starting from Week 17 of treatment, individual participants may have their dose up-titrated to 3 mg/kg SC QW if they experience suboptimal bleeding control.
~At the Week 53 clinic visit following consultation with the treating physician, parents/caregivers may elect for their child to continue with the maintenance 3-mg/kg SC Q2W dosing regimen or to switch to the maintenance 1.5-mg/kg SC QW or 6-mg/kg SC once every 4 weeks (Q4W) dosing regimen for the subsequent 7-year long-term follow-up period.
~During the study, participants will be treated with emicizumab until unacceptable toxicity, discontinuation from the study due to any cause, or other criteria specified in the protocol, whichever occurs first."
16413064|NCT04430387|Device|The saliva ejector|A thin suction tube that draws water, saliva, blood, and debris from the mouth to provide patient comfort, preventing patient from constantly having to sit up and spit while maintain a clear operative field. It is connected through the low-volume suction hose in the dental chair. It can be held by the dental assistant, the dental provider or by the patient. In practice, it can be also contoured and hang by the cheek of the patient due to its light weight.
16413154|NCT04265911|Biological|PPSV23 (intramuscular)|Intramuscular injection
16413065|NCT04430387|Device|The high-volume evacuator|The high-velocity air evacuation device. It is connected through the high-volume suction hose in the dental chair. It is operated by a dental assistant during the dental treatment, owing to the challenge posed by the rigid disposable attachment and bulky high-volume suction hose.
16413066|NCT04430387|Device|The DryShield|The device is attached to the high-volume suction hose to provide continuous suction of intraoral fluid and debris, and also simultaneous isolation to both maxillary and mandibular quadrants on the same side. Other advantages of these devices include retracting the tongue and cheek, and prevention of aspiration.
16413067|NCT04420624|Drug|Colchicine|1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month
16413068|NCT04417907|Drug|Perampanel 1 week titration|Healthy adults will take 2mg perampanel PO QD for one week followed 4mg perampanel PO QD for five weeks.
16413069|NCT04417907|Drug|Perampanel 2 week titration|Healthy adults will take 2mg perampanel PO QD for two weeks followed 4mg perampanel PO QD for four weeks.
16413070|NCT04417907|Drug|Perampanel 4mg|Healthy adults will take 4mg perampanel PO QD for six weeks
16413071|NCT04417907|Drug|Placebo|Healthy adults will take 2mg placebo PO QD for six weeks
16413072|NCT04408963|Biological|VRC-HIVMAB0102-00-AB|The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the Cterminus of the heavy chain constant region designed to improve antibody half-life in vivo.
16413073|NCT04403022|Device|Robotic Assisted Surgery|da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision
16413074|NCT04396535|Drug|Bintrafusp Alfa|Given IV
16413075|NCT04396535|Drug|Docetaxel|Given IV
16413076|NCT04392856|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)|The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
16413077|NCT04392856|Behavioral|Same than experimental condition (UP), after it finishes|The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Homeless Women. The protocol contains five modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) countering emotional behaviors, (4) recognizing and confronting physical sensations, and (5) emotion exposures. This adaptation of Unified Protocol is organized in twelve sessions: Emotional disorders and emotional regulation; Motivation for change; Understanding the role of emotions; Mindful emotion awareness, Cognitive flexibility, Understanding and confronting physical sensations, Countering emotional behaviors, Emotional avoidance, Emotion exposure; Achievement recognition and look to the future; and Relapse prevention and closure.
16413078|NCT04390750|Behavioral|Care Partner-Assisted Intervention|Tailored teaching and coaching
16413079|NCT04383210|Drug|Seribantumab|Anti-HER3 monoclonal antibody
16413080|NCT04381832|Drug|Etrumadenant|Etrumadenant is an A2aR and A2bR antagonist
16413081|NCT04381832|Drug|Zimberelimab|Zimberelimab is an anti-PD-1 antibody
16413082|NCT04381832|Drug|AB680|AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
16413083|NCT04381832|Drug|Enzalutamide|Enzalutamide is an androgen receptor inhibitor
16413084|NCT04381832|Drug|Docetaxel|Docetaxel is type of chemotherapy
16413085|NCT04381143|Drug|Aspirin 100 mg Oral Tablet|Aspirin 100 mg tablets daily
16413086|NCT04379024|Drug|DUAVEE 0.45Mg-20Mg Tablet|One capsule daily for 6 months (+/- 1 month)
16413087|NCT04377100|Behavioral|Computer task questionnaires|MH COVID-19 Adult, MASQ-SF, STAI, ACS, Hollingshead, DSM XC, PMHC, AUDIT, debriefing questionnaire, and finger-tapping task
16413088|NCT04376424|Diagnostic Test|Hand Held Ultrasound|Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
16413089|NCT04370795|Drug|Sirolimus|Post transplant immunosuppressant drug
16413090|NCT04370795|Drug|Busulfan|Conditioning drug
16413091|NCT04370795|Drug|Horse -Anti-thymocyte|Immune suppression conditioning drug
16413092|NCT04370795|Drug|G-CSF|Used to prevent infection and neutropenic fevers caused by chemotherapy
16413093|NCT04370795|Radiation|Total Body Irradiation (TBI)|Conditioning (only patients in Group 1 will receive TBI)
16413094|NCT04360850|Behavioral|online survey|A brief survey for therapists to fill out
16413095|NCT04353804|Other|Treatment Arm: Computerized Cognitive Rehabilitation|Treatment Arm: Computerized Cognitive Rehabilitation
16413096|NCT04353804|Other|Active Control computer games|Active Control computer games
16413097|NCT04351373|Drug|intravenous fluorescein sodium|Injection of IV FS during acoustic neuroma tumor removal
16413098|NCT04351373|Device|YELLOW 560 nm microscope filter (YE560)|The surgeon will utilize the microscope filter after the IV FS is administered
16413099|NCT04350177|Drug|IkT-148009|Oral administration gelatin capsule
16413100|NCT04350177|Drug|Placebo|Oral administration gelatin capsule
16413101|NCT04339751|Drug|Vorinostat|Administration of Vorinostat
16413102|NCT04339738|Drug|Cabozantinib S-malate|Given PO
16413103|NCT04339738|Biological|Nivolumab|Given IV
16413104|NCT04339738|Drug|Paclitaxel|Given IV
16413105|NCT04339738|Other|Quality-of-Life Assessment|Ancillary studies
16413106|NCT04339738|Other|Questionnaire Administration|Ancillary studies
16413107|NCT04338269|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
16413108|NCT04338269|Drug|Cabozantinib|Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
16413109|NCT04336982|Drug|CC-90009|Injection
16413110|NCT04336982|Drug|Venetoclax|Tablet
16413111|NCT04336982|Drug|Azacitidine|Injection
16413112|NCT04336982|Drug|Gilteritinib|Tablet
16413113|NCT04334941|Drug|Atezolizumab|Given IV
16413115|NCT04322084|Other|Wearable Sensors|To develop predictive algorithms that identify early onset of sepsis in children being treated for ALL. This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for the design of predictive models.
16413116|NCT04320888|Drug|Selpercatinib|Given PO
16413117|NCT04317417|Behavioral|EMPOWER|"Participants will receive weekly material for a total of 5 weeks consisting of 1-2 days of didactic content and several days of brief, real-life skills practice and reporting taking approximately 10-15 minutes to complete. Adolescents and young adults cannot skip ahead, but they can return to old lessons or exercises if they choose. Most exercises are done in a diary format in which past responses are displayed next to their new ones, so that every time they visit that exercise they see their growing list of past positive experiences. Participants will be permitted up to 8 weeks to complete this self-guided intervention."
16413118|NCT04316559|Drug|TRV734|biased agonist at mu opioid receptors
16413119|NCT04316559|Other|Placebo|Placebo capsule
16413120|NCT04316546|Drug|Miransertib (ARQ092)|ARQ 092 (miransertib) is a small molecule developed by ArQule Inc., a wholly owned subsidiary of Merck &amp; Co. that effectively inhibits AKT. Proteus syndrome is caused by mosaic activating mutations in AKT1. This is a Phase 2 trial investigating the efficacy of miransertib as a treatment for adult and pediatric patients with Proteus syndrome.
16413121|NCT04310020|Drug|Atezolizumab|Given IV
16413122|NCT04310020|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
16413123|NCT04308785|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.
16413124|NCT04308785|Drug|Tiragolumab|Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.
16413125|NCT04308785|Other|Placebo|Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.
16413126|NCT04304820|Drug|Eltrombopag|Between 12 and 17yo (adult dose of 150mg) Between 6 and 11yo (75 mg) Between 3 and 5 yo (2.5 mg/kg)
16413127|NCT04304820|Drug|Cyclosporine|Day 1 to start of h-ATG: 2mg/kg/day by mouth (All subjects) Start of h-ATG to Month 6: 3 mg/kg/dose by mouth administered every 12 hours (12yo and above) 6 mg/kg/dose by mouth administered every 12 hours (less than 12yo) Month 6 to Month 24: Dosing to be adjusted based on response
16413128|NCT04304820|Drug|Horse-Anti-thymocyte-Globulin|h-ATG at a dose of 40 mg/kg/day for 4 days (intravenously for approximately 4 hours daily) Note: Omitted in patients who have achieved a complete response at the initial NIH visit after initiating oral treatment remotely
16413129|NCT04301414|Drug|BMS-986218 and Degarelix|BMS-986218 20mg IV every 2 weeks x 2 doses starting 3 weeks prior to radical prostatectomy plus degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy.
16413130|NCT04301414|Drug|Degarelix|Degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy
16413131|NCT04300296|Drug|Cutaneous lichen planus secukinumab 300 mg Q4W|All cutaneous lichen planus patients assigned to active secukinumab will receive 2x 1ml PFS at randomization, Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 32.
16413132|NCT04300296|Drug|Cutaneous lichen planus placebo|All cutaneous LP patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontanoues remision) for weekly dosis until Week 20, then bi-weekly injection of secukinumab until Week 30
16413133|NCT04300296|Drug|Mucosal lichen planus placebo|All mucosal lichen planus patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontaneous remission) for weekly dosis until Week 20, then bi-weekly injection of secukinumab until Week 30
16413134|NCT04300296|Drug|Lichen planopilaris placebo|All lichen planopilaris patients assigned to placebo will receive 2x 1ml placebo PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will be switched to secukinumab (if no spontanoues remision) for weekly dosis until week 20, then bi-weekly injection of secukinumab until Week 30
16413135|NCT04300296|Drug|Mucosal lichen planus secukinumab 300 mg Q4W|All mucosal lichen planus patients assigned to active secukinumab will receive 2x 1ml PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 30.
16413136|NCT04300296|Drug|Lichen planopilaris secukinumab 300 mg Q4W|All lichen planopilaris LP patients assigned to active secukinumab will receive 2x 1ml PFS at randomization , Week 1, Week 2, Week 3, Week 4, Week 8 and Week 12. At Week 16, they will stay on the weekly placebo dosis and monthly secukinumab until Week 30.
16413137|NCT04296136|Other|Advance Care Planning Discussion|Goals of care discussion with patient, documentation with electronic health record note and advance care planning billing. This will also include: pharmacy review of medications, case management review, and coding specialist review.
16413138|NCT04289571|Diagnostic Test|VR Motility Tool|Participant wears VR goggles and interacts with a visual avatar via a control unit to navigate four courses. Derived parameters automatically recorded by the VR system include number and type of collisions, walking speed, task time, and distance walked.
16413139|NCT04289298|Behavioral|Engage-A|Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
16413140|NCT04289298|Other|Training and utilizing Engage-A therapy|Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.
16413141|NCT04284774|Drug|Tipifarnib|Given PO or via nasogastric or gastric tube
16413142|NCT04272008|Drug|Segesterone Acetate and Ethinyl Estradiol|Annovera taken alone
16413143|NCT04272008|Other|Tampon|Annovera with tampon use
16413144|NCT04269902|Biological|Obinutuzumab|Given IV
16413145|NCT04269902|Other|Quality-of-Life Assessment|Ancillary studies
16413146|NCT04269902|Other|Questionnaire Administration|Ancillary studies
16413147|NCT04269902|Drug|Venetoclax|Given PO
16413155|NCT04260126|Combination Product|Pembrolizumab and PDS0101|IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35.
16413156|NCT04258566|Device|Optical Molecular Imaging|Tracks and localizes intrahepatic lesions
16413157|NCT04258566|Radiation|Indocyanine Green|Fluorescent dye used for visualization of cells and tissue
16413158|NCT04257929|Drug|Pitolisant oral tablets|"Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
~Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant."
16413159|NCT04257929|Drug|Placebo oral tablet|Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
16413160|NCT04252040|Device|Active tDCS with guided imagery|The subject will be positioned in the sitting/reclining position in a quiet room with lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus active tDCS arm will have 20 minutes of stimulation with 25 minutes of guided imagery.
16413161|NCT04250662|Device|Active tDCS with guided imagery|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus active tDCS arm will have 20 minutes of stimulation with 25 minutes of guided imagery.
16413162|NCT04250662|Device|Active tDCS alone (no guided imagery)|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. Active tDCS arm alone without guided imagery, will have 20 minutes of tDCS stimulation without guided imagery.
16413163|NCT04250662|Device|Sham tDCS with guided imagery|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus sham tDCS arm will have 30 seconds of tDCS stimulation with 25 minutes of guided imagery.
16413164|NCT04250662|Device|Sham tDCS alone (no guided imagery)|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. Sham tDCS alone arm will have 30 seconds of tDCS stimulation without guided imagery.
16413165|NCT04248218|Behavioral|Active Rehabilitation Group/Case|If the patient is in the active rehabilitation group, the patient will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. In addition, they will also watch a two-minute video by the PI and research team reinforcing the active rehabilitation instructions.
16413166|NCT04243122|Drug|Apixaban 2.5 MG Oral Tablet [ELIQUIS]|2.5mg twice per day for 6 months Then treated & followed up as per standard of care
16413167|NCT04243122|Drug|Aspirin 81 mg|81mg once per day for 6 months Then treated & followed up as per standard of care
16413168|NCT04229095|Drug|Suvorexant 20 mg|Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit
16413169|NCT04229095|Drug|Placebo oral tablet|Single-dose administration of placebo given on an inpatient clinical research unit
16413170|NCT04225676|Biological|Tisagenlecleucel|"Tisagenlecleucel Cell Dispersion for Infusion given once during the study.
~The approved dose range for tisagenlecleucel is: 0.2 to 5.0×106 CAR positive viable T cells / kg for patients' ≤ 50 kg body weight or 0.1 to 2.5×108 CAR-positive viable T cells for patients > 50 kg body weight."
16413171|NCT04214262|Drug|Atezolizumab|Given IV
16413172|NCT04214262|Other|Quality-of-Life Assessment|Ancillary studies
16413173|NCT04214262|Other|Questionnaire Administration|Ancillary studies
16413174|NCT04214262|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16413175|NCT04210843|Drug|Ligelizumab|liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL
16413176|NCT04206319|Drug|Radium-223|an alpha particle-emitting drug, dose consists of 55 kBq/kg (1.49 microcurie/kg); administered every 4 days
16413177|NCT04206319|Drug|18F Sodium Fluoride|18F-NaF (Sodium Fluoride) is a radio-pharmaceutical used to image skeletal pathology with positron emission tomography (PET) imaging
16413178|NCT04196569|Device|Alcon Trifocal and Trifocal Toric Intraocular Lenses|"Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics:
~TFAT30, TFAT40, TFAT50, TFAT60"
16413179|NCT04195555|Drug|Ivosidenib|Given PO
16413180|NCT04191304|Biological|Benralizumab|Benralizumab solution for injection in an accessorised prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks
16413181|NCT04191304|Biological|Placebo|Matching placebo solution for injection in an APFS will be administered SC every 4 weeks
16413182|NCT04184895|Biological|ASP2390|Intradermal
16413183|NCT04184895|Biological|Placebo|Intradermal; normal saline solution
16413184|NCT04184882|Drug|Bocidelpar|Oral
16413185|NCT04184882|Drug|Placebo|Oral
16413186|NCT04183205|Diagnostic Test|LDAEP|This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.
16413187|NCT04183205|Drug|Placebo|placebo pills of the same size, color and taste as the active drug will be administered
16413188|NCT04183205|Drug|sertraline|Sertraline is an FDA approved SSRI for treatment of PTSD.
16413189|NCT04181762|Drug|secukinumab|STUDY DRUG
16413190|NCT04176718|Drug|Daratumumab|predetermined dose, intravenously, at predetermined times per cycle
16413191|NCT04176718|Drug|Carfilzomib|predetermined dose, intravenously, give 3 times per cycle
16413192|NCT04176718|Drug|Pomalidomide|predetermined dose, orally, daily per cycle
16413193|NCT04176718|Drug|Dexamethasone|predetermined dose, orally, given 8 times per cycle
16413194|NCT04176198|Drug|TP-3654|Oral PIM Inhibitor
16413195|NCT04164082|Drug|Gemcitabine Hydrochloride|Given intravesically
16413196|NCT04164082|Biological|Pembrolizumab|Given IV
16413197|NCT04163406|Dietary Supplement|ferrous fumarate|Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate
16413198|NCT04163406|Dietary Supplement|ferrous fumarate + GOS|Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and GOS (3g)
16413199|NCT04163406|Dietary Supplement|ferrous fumarate + HMOs|Maize-based porridge fortified with iron (5mg) in form of ferrous fumarate and HMOs (2'-FL (2g) + LNnT(1g))
16413200|NCT04154020|Procedure|Flexor tenotomy|Tenotomy(cutting) of flexor tendons is performed with needle
16413201|NCT04148911|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 840 mg via IV infusion
16413202|NCT04148911|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered at the 100 mg/m2 dose via IV infusion on Days 1, 8, and 15 of every 28-day cycle
16413203|NCT04147832|Other|Alert to provider|Provider will receive an alert of sub-optimal patient attendance using 4 rules.
16413204|NCT04145453|Behavioral|Intervention genotype personalized nutritional recommendations|Participants will receive personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the beginning of study
16413205|NCT04145453|Behavioral|Control Group 1 personalized nutritional recommendations|Participants will receive genotype personalized nutritional recommendations to increase fruit and vegetables consumption. Information about genotype will be given at the end of study
16413206|NCT04145453|Behavioral|Control Group 2 general nutritional recommendations|Participants will receive general nutritional recommendations to increase fruit and vegetables consumption
16413207|NCT04145115|Biological|Ipilimumab|Given IV
16413208|NCT04145115|Biological|Nivolumab|Given IV
16413209|NCT04132804|Behavioral|Tai Chi|Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness.
16413210|NCT04130932|Other|Ergonomic flooring|Specially designed flooring system to optimize ergonomics of participants
16413211|NCT04127539|Behavioral|Strong & Steady exercise program|The community-based group exercise program S&S, with strengthening and balance exercise as the main components. The participants will attend a once-weekly, one hour supervised session. The exercises that will be used can be found in the S&S handbook which includes different difficulty levels. All instructors are volunteers and have completed the S&S education. Each exercise session will consist of a warm-up (5-8 min.), endurance exercises (10-15 min.), strength exercises (15 min.), balance exercises (20 min.) and a cool down/stretching (5 min.). In addition to attending the group exercises, the participants will be taught and encouraged to do home exercises twice a week from hand out leaflets that can be found at www.sterkogstodig.no.
16413212|NCT04120246|Drug|Alpha-tocopheryloxyacetic Acid|Given PO
16413213|NCT04120246|Biological|Trastuzumab|Given IV
16413214|NCT04118764|Device|Neuronavigation-guided single-element focused ultrasound transducer|Non-invasive focused ultrasound-induced blood-brain barrier opening will be attempted using a single-element transducer, guided with a neuronavigation system.
16413215|NCT04118764|Drug|Definity|Definity microbubbles (10 μl/kg) will be used in conjunction with the ultrasound transducer to temporarily open the blood brain barrier.
16413216|NCT04118764|Other|Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents|MRI scans will be completed at baseline and immediately after the focused ultrasound treatment to confirm BBB opening and safety. A follow-up MRI will be performed three days after treatment to confirm BBB closure, only in the case of successful BBB opening.
16413217|NCT04118764|Other|Positron Emission Tomography (PET)|A follow-up PET scan will be performed three days after treatment to determine amyloid plaque load.
16413218|NCT04118764|Other|Amyvid|To be used during the PET scan to determine uptake of Amyvid within the treated area.
16413219|NCT04112199|Drug|BIV201 continuous infusion|BIV201 continuous infusion with terlipressin for a total of two 28 day cycles. Initiate treatment at 3 mg per 24 hour period and titrate stepwise up to a maximum of 8 mg per 24 hour period based on tolerability and response.
16413220|NCT04102098|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
16413221|NCT04102098|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
16413222|NCT04099355|Drug|Dronabinol 5mg Cap|PO QHS 14 days
16413223|NCT04099355|Drug|Non-active comparator|PO QHS 14 days
16413224|NCT04097236|Other|Qualitative and quantitative assessment of gastric content volume with bed elevation|Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).
16413225|NCT04097236|Other|Qualitative and quantitative assessment of gastric content volume without bed elevation|Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).
16413226|NCT04095273|Drug|Elimusertib (BAY1895344)|Study drugs will be administered as scheduled
16413227|NCT04095273|Drug|Pembrolizumab|Study drugs will be administered as scheduled
16413228|NCT04092283|Drug|Carboplatin|Given IV
16413229|NCT04092283|Drug|Cisplatin|Given IV
16413230|NCT04092283|Biological|Durvalumab|Given IV
16413231|NCT04092283|Drug|Etoposide|Given IV
16413234|NCT04086485|Drug|Lu-177-DOTATATE|Lu-177-DOTATATE will be given by IV every 8 (+/-2) weeks for a total of 4 administrations
16413235|NCT04086485|Drug|Olaparib|Olaparib is given as a pill taken orally and is to be taken twice a day, starting from 2 days before the first administration of Lu-177-DOTATATE until 4 weeks after the last administration
16413236|NCT04086485|Diagnostic Test|Ga dotatate scanning|Ga68-DOTATATE PET /CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
16413237|NCT04086485|Diagnostic Test|FDG-PET scanning|F18-FDG PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
16413238|NCT04083430|Drug|Yellow Fever Vaccine|"STAMARIL, powder and solvent for suspension for injection in pre-filled syringe.
~After reconstitution, 1 dose (0.5 ml) contains: Yellow fever virus1 17D-204 strain (live, attenuated) not less than 1000 IU.
~Powder and solvent for suspension for injection.
~Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a limpid solution."
16413239|NCT04077099|Drug|REGN5093|Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
16413240|NCT04075318|Biological|UB-312|A synthetic peptide-based vaccine
16413241|NCT04075318|Biological|Placebo|Matching placebo
16413242|NCT04066205|Behavioral|SLEEPSAMRT|SLEEPSMART will be designed to improve sleep by providing guidance and structure to assist JIA children and their parent in adhering to the intervention protocol. The intervention will be interactive and personalized; users will interface with three primary components:1) monitoring: daily records of sleep and symptoms; 2) skill building modules: sleep education, sleep skills training, relaxation techniques, positive coping skills, and reward systems for activity participation for reducing sleep deficiency; and 3) assignment review and personalized feedback via behavioral assignments for skill implementation and tailored feedback. Modules will take an estimated 30 minutes each week to complete and will include multimedia elements to enhance learning.
16413243|NCT04065984|Device|Microstim 2v2 Stimulator|Neuro-muscular electrical stimulator portable device (9v battery) connected to the skin participant over the muscle body of choice using self adhesive electro-gel pads. Treatment devices and placebo devices.
16413244|NCT04054752|Biological|Recombinant human IL-7-hyFc (NT-I7)|NT-I7 administered at escalating doses of 720, and 960g/kg to determine OBD of NT-I7
16413245|NCT04054752|Biological|Vaccine sequence 1|Day 1 Immunization Pre-NT-I7:Td and Polio Day 64, Immunization Post-NT-I7: Hep A#1, Hep B#1 Day 106: Hep B#2 (Optional) 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1
16413246|NCT04054752|Biological|Vaccine sequence 2|Day 1 Immunization Pre-NT-I7: Hep A#1, Hep B#1 Day 64, Immunization Post-NT-I7:Td and Polio, PCV13 Day 106: no Vaccine 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1
16413247|NCT04053881|Drug|Certolizumab pegol|Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection
16413248|NCT04049825|Drug|OPB-111077|OPB-111077+bendamustine
16413249|NCT04049825|Drug|OPB-111077|OPB-111077+rituximab+bendamustine
16413250|NCT04045210|Other|Psychological Support Based on Positive Suggestions|Eligible patients will be randomized at the earliest possible time after meeting inclusion criteria. Patients will be randomized 1:1:1 to intervention by either doulas or a psychiatrist or a non-intervention arms stratified by ICU location. Both intervention and controls will receive standard medical care at the discretion of the ICU team. The intervention arm will receive PSBPS as soon as feasible and continue on a daily basis. Doulas/psychiatrist will also liaise with family, the team, and with the nursing staff. Both intervention and standard of care arms will complete follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 6 months follow up by phone. All the patients randomized to the intervention arm will receive the same intervention.
16413251|NCT04042077|Drug|Delafloxacin|Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
16413252|NCT04042077|Drug|Vancomycin|Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
16413253|NCT04042077|Drug|Linezolid|Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
16413254|NCT04042077|Drug|Piperacillin/Tazobactam|Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
16413255|NCT04042077|Drug|Tigecycline|Powder for solution for infusion 50 mg, TID, for 5 to 14 days
16413256|NCT04040569|Radiation|Radiomics on MRI|"Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic Shell feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence."
16413257|NCT04026113|Drug|Linaclotide 72 μg (FC Participants)|Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)
16413258|NCT04026113|Drug|Placebo (FC Participants)|Matching placebo
16413259|NCT04026113|Drug|Linaclotide 145 μg (IBS-C Participants)|Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)
16413260|NCT04026113|Drug|Linaclotide 290 μg (IBS-C Participants)|Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)
16413261|NCT04025554|Drug|Anakinra|100 mg daily weeks 1-4, 200 mg daily weeks 5-8, 300 mg daily weeks 9-12.
16413262|NCT04020276|Radiation|SBRT|Participants will receive 5 fractions of radiation, which will be delivered 2-3 times per week. SBRT should be complete in a 1.5 to 2 week time frame. There should be a minimum of 12 hours between treatments. Each fraction will be escalated or de-escalated to meet the overall constraints in phase IA or both previously identified constraints in phase IB
16413263|NCT04008537|Device|Ring gantry kV-CBCT combined with linear accelerator|Each imaging session will be less than one hour, and is expected to take no more than 15 minutes.
16413264|NCT04007601|Device|Active tDCS|Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
16413537|NCT03341962|Drug|Placebo|Tablets manufactured to mimic IMU-838 tablets
16413265|NCT04007601|Device|Sham tDCS|Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
16413266|NCT04001504|Biological|Double Dose Quadrivalent Influenza Vaccine|Double Dose QIV (30µg Hemagglutinin)
16413267|NCT04001504|Biological|Standard Dose Quadrivalent Influenza Vaccine|Standard Dose QIV (15µg Hemagglutinin)
16413268|NCT03997409|Other|Dietary Intervention|The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
16413269|NCT03991169|Drug|Ferrous Sulfate|Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg/kg/day of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight >43 kg.
16413270|NCT03991156|Device|Audio-Visual Assisted Therapeutic Ambience in Radiotherapy|Audio Visual System
16413271|NCT03991156|Other|Quality of Life Survey, PedsQL3.0|Quality of life survey using the PedsQL 3.0 Cancer Module
16413272|NCT03991156|Other|Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)|Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).[24] is a survey to measure anxiety
16413273|NCT03987139|Other|Hypertension|"Hypertension is induced by an infusion of noradrenaline within acceptable limits Baseline recording (10 minutes) is performed. MAP gradually increases in steps of 5-10 mmHg during ongoing TCD. When the desired maximum MAP is reached, measurement is made at steady state (10 minutes).
~Noradrenaline infusion is stopped. When MAP is stabilized, new baseline is measured for 10 minutes."
16413274|NCT03987139|Other|Hyper- and hypoxia|The mechanical ventilator is adjusted to mild hypoxia, normoxia and mild hyperoxia. Measurements are made for 10 minutes at normoxia and after steady state is reached, respectively. hyperoxia and hypoxia. Oxygenation is controlled by arterial blood gas before and during steady state.
16413275|NCT03987139|Other|Hyper- and hypocapnia|The mechanical ventilator is adjusted to a delta PaCO2 on the ventilator for both hypocapnia and hypercapnia. Measurements are made for 10 minutes at normocapnia and after steady state is reached, respectively. hyper- and hypocapnia.
16413276|NCT03984058|Behavioral|Lifestyle Intervention|A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
16413277|NCT03965845|Drug|Telaglenestat (CB-839)|Teleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles.
16413278|NCT03965845|Drug|Palbociclib Oral Capsule or Tablet [Ibrance]|Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken.
16413279|NCT03953976|Radiation|Intensity modulated radiation therapy (IMRT)|Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
16413280|NCT03950232|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first
16413281|NCT03949140|Procedure|Laser hair removal|Those who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks.
16413282|NCT03946800|Biological|MEDI1191|Subjects will receive MEDI1191 (at least twice)
16413283|NCT03946800|Biological|Durvalumab|Subject will receive durvalumab every 4 weeks
16413284|NCT03943693|Device|Double shock|Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized. If the first attempt with this approach fails to terminate atrial fibrillation a second attempt will be made using the same approach. If the second attempt fails the dual shock approach will be considered to have failed and further treatment will be determined by the primary team/attending cardiologist.
16413285|NCT03943693|Device|Single shock|Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only. A repeat attempt will be made using the same approach if the initial shock fails. If the second attempt fails, the single shock approach will be considered to have failed. Patients will be crossed over to dual shock therapy while under the same sedation episode. For cross-over patients, two near-simultaneous 200-Joule shocks will be delivered through the two sets of pads already in position. If this fails further treatment will be determined by the primary team/attending cardiologist.
16413286|NCT03941600|Behavioral|Community-based Exercise Intervention group (CBE)|The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
16413529|NCT03347695|Procedure|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
16413287|NCT03941600|Behavioral|Exercise Education Control group (EEG)|The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
16413288|NCT03938246|Drug|TVB-2640|Oral dose, tablet, daily dosing
16413289|NCT03938246|Other|Placebo|Oral dose, tablet, daily dosing
16413290|NCT03926039|Behavioral|sharing decision-making program|Sharing decision-making talks and decision-making assistance tools used in the process
16413291|NCT03921515|Other|Blister induction|Blister induction involves creating 8 blisters on the forearm and removing the tops of the blisters for primary cell culture derivation. After blister induction, subjects may have an optional overnight admission to assess cell infiltration in response to autologous serum and/or sterile saline solution.
16413292|NCT03921515|Other|Skin Biopsies|The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, followed by a punch biopsy 3 (plus or minus 1) and 7 (plus or minus 2) days later using a 3 mm punch to encompass the initial biopsy sites, capturing the tissue at 3 and 7 days of healing.
16413293|NCT03914625|Drug|Asparaginase Erwinia chrysanthemi|Given IV or IM
16413294|NCT03914625|Biological|Blinatumomab|Given IV
16413295|NCT03914625|Drug|Cyclophosphamide|Given IV
16413296|NCT03914625|Drug|Cytarabine|Given IT or IV
16413297|NCT03914625|Drug|Dexamethasone|Given PO or IV
16413298|NCT03914625|Drug|Doxorubicin Hydrochloride|Given IV
16413299|NCT03914625|Drug|Leucovorin Calcium|Given PO or IV
16413300|NCT03914625|Drug|Mercaptopurine|Given PO
16413301|NCT03914625|Drug|Mercaptopurine Oral Suspension|Given PO
16413302|NCT03914625|Drug|Methotrexate|Given IT or IV
16413303|NCT03914625|Drug|Pegaspargase|Given IV or IM
16413304|NCT03914625|Drug|Prednisolone|Given PO or IV
16413305|NCT03914625|Drug|Prednisone|Given PO or IV
16413306|NCT03914625|Radiation|Radiation Therapy|Undergo cranial radiation therapy
16413307|NCT03914625|Radiation|Radiation Therapy|Undergo testicular radiation therapy
16413308|NCT03914625|Drug|Thioguanine|Given PO
16413309|NCT03914625|Drug|Vincristine Sulfate|Given IV
16413310|NCT03914612|Drug|Carboplatin|Given IV
16413311|NCT03914612|Drug|Paclitaxel|Given IV
16413312|NCT03914612|Biological|Pembrolizumab|Given IV
16413313|NCT03914612|Other|Placebo Administration|Given IV
16413314|NCT03914612|Other|Quality-of-Life Assessment|Ancillary studies
16413315|NCT03914612|Other|Questionnaire Administration|Ancillary studies
16413316|NCT03905707|Drug|glepaglutide|Glucagon-Like Peptide-2 (GLP-2) analog
16413317|NCT03905525|Drug|CFZ533|Biological
16413318|NCT03905525|Other|Placebo|liquid placebo for injections
16413319|NCT03896516|Other|Placebo|Participants will take GLWL-01 450 mg b.i.d. or matched placebo for up to 16 days
16413320|NCT03896516|Drug|GLWL-01|A within-subject, counterbalanced, double-blind, placebo-controlled study. Participants will take GLWL-01 450 mg b.i.d. or matched placebo for a minimum of 4 days (Stage I). After a wash-out window, Stage II will take place during which the counterbalanced study drug will be administered for a minimum of 4 days.
16413321|NCT03895658|Device|MRI|Structural and functional neuroimaging pre and post ECT treatment
16413322|NCT03895658|Device|MagPro TMS stimulator and coil|Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment
16413323|NCT03895658|Device|MECTA paired with the 4X1 HD-ECT|Multichannel Stimulation Interface (Model 4X1E1)
16413324|NCT03890614|Other|Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspirates|Bone marrow aspirates will be collected from participants with multiple myeloma being evaluated for relapsed disease to create three-dimensional constructs using a three-dimensional bioprinting methodology for automated organoid biofabrication.
16413325|NCT03870334|Drug|BT-11 1,000 mg|Subjects will be randomized to receive BT-11 1,000 mg once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
16413326|NCT03870334|Drug|Placebo|Subjects will be randomized to receive Placebo once daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
16413327|NCT03870243|Device|Bubble CPAP|To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
16413328|NCT03870243|Device|Low flow oxygen|To see the effectiveness of low flow oxygen in children with severe pneumonia
16413329|NCT03861221|Device|CBBCT|To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions.
16413330|NCT03857256|Drug|CP105F|Natural Health Product
16413331|NCT03857256|Drug|Placebo|tablet manufactured to mimic the CP105F beta-glucan
16413332|NCT03856684|Behavioral|Self-sampling kit sent at home|"Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
~When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16413333|NCT03856684|Behavioral|Self-sampling kit sent at home + SMS reminder|"Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
~After 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return :
~the receipt of the vaginal self-sample at the laboratory
~the performance of a pap smear
~Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16413538|NCT03324581|Drug|OPC-64005|OPC-64005 film coated tablets
16413334|NCT03856684|Behavioral|"Letter offering a self-sampling kit on request+ SMS reminder"|"Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (kit provided on request) or to perform a pap smear.
~Women are invited to ask the kit online, on our website.
~For the women who ask the kit, after 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return :
~the receipt of the vaginal self-sample at the laboratory
~the performance of a pap smear
~Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16413335|NCT03856684|Behavioral|"SMS offering a self-sampling kit on request+ SMS reminder"|"Selected women receive a SMS inviting them to ask a vaginal self sampling kit to perform a sample at home and send it to a laboratory (kit provided on request).
~Women are invited to ask the kit by answering 1 by SMS.
~For the women who ask the kit, after 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return :
~the receipt of the vaginal self-sample at the laboratory
~the performance of a pap smear
~Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16413336|NCT03851081|Biological|Inotuzumab Ozogamicin|Given IV
16413337|NCT03851081|Other|Quality-of-Life Assessment|Ancillary studies
16413338|NCT03851081|Drug|Vincristine Sulfate Liposome|Given IV
16413339|NCT03850795|Drug|HC-1119|oral once daily 80 mg
16413340|NCT03850795|Drug|Enzalutamide|oral once daily 160 mg
16413341|NCT03841669|Behavioral|Aerobic Exercise Group|Guidelines for exercise programming (ACSM, 2018) will be followed including a warm up and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, twice a week, for 12 months. They will also exercise on their own for 30 minutes, 1 time a week, for 12 months. This gives a total of 3 exercise sessions a week. The prescribed intensity will be based on their maximal fitness testing heart rate and then calculated per a research grade method. They will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps.
16413342|NCT03841669|Behavioral|Physical Activity & Health Information Group|This group will not partake in the aerobic fitness sessions but will be asked to wear a daily monitoring device every 6 weeks. They will also complete all baseline, 6-month (optional), and 12-month visits.
16413343|NCT03841448|Drug|Placebo|Normal saline (0.9% NaCl) matching volume of cemdisiran doses will be administered SC.
16413344|NCT03841448|Drug|Cemdisiran|Cemdisiran will be administered by subcutaneous (SC) injection.
16413345|NCT03834350|Other|BREATHES Program|Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal. A small device will be attached to track real-time medication use.
16413346|NCT03834350|Device|BREATHES SpiroPD or Propeller Health|At the time of their initial study visit, study participants may be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal. A small device will be attached to track real-time medication use.
16413347|NCT03827798|Drug|CFZ533|s.c.
16413348|NCT03827798|Drug|Placebo to CFZ533|s.c.
16413349|NCT03827798|Drug|LYS006|p.o.
16413350|NCT03827798|Drug|Placebo to LYS006|p.o.
16413351|NCT03827798|Drug|MAS825|s.c.
16413352|NCT03827798|Drug|Placebo to MAS825|s.c.
16413353|NCT03825289|Drug|Hydroxychloroquine|Given PO
16413354|NCT03825289|Drug|Trametinib|Given PO
16413355|NCT03811002|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16413356|NCT03811002|Drug|Atezolizumab|Given IV
16413357|NCT03811002|Drug|Carboplatin|Given IV
16413358|NCT03811002|Drug|Cisplatin|Given IV
16413359|NCT03811002|Drug|Etoposide|Given IV
16413360|NCT03811002|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16413361|NCT03811002|Other|Quality-of-Life Assessment|Ancillary studies
16413362|NCT03811002|Other|Questionnaire Administration|Ancillary studies
16413363|NCT03809533|Drug|sofosbuvir/velpatasvir|12-week, oral, fixed-dose
16413364|NCT03793179|Drug|Carboplatin|Given IV
16413365|NCT03793179|Biological|Pembrolizumab|Given IV
16413366|NCT03793179|Drug|Pemetrexed|Given IV
16413367|NCT03793166|Drug|Cabozantinib|Given PO
16413368|NCT03793166|Biological|Ipilimumab|Given IV
16413369|NCT03793166|Biological|Nivolumab|Given IV
16413370|NCT03793166|Other|Quality-of-Life Assessment|Ancillary studies
16413371|NCT03793166|Other|Questionnaire Administration|Ancillary studies
16413372|NCT03788993|Other|Blue-depleted evening light condition|"A 20-bedded ward with tunable light emitting diode (LED) lamps. At 18:00h the lighting undergoes a 30-minute transition during which the green and blue LEDs are dimmed to produce blue-depleted amber colored lighting. At 06:50h a new 10-minute transition changes the light color to ordinary indoor lighting. From 07:00h to 18:00h, there is ordinary indoor lighting (3000K colour temperature). The light intensity is dimmed to 20% of the maximum from 23:00h to 6:50h.
~Blue-blocking window filters are deployed also in the evening. All TV sets have permanent blue-blocking filters and individuals are provided with blue-blocking screens that can be attached to the front of personal electronic devices. If the patients leave the blue-depleted unit after 18:30 they are offered blue-blocking glasses to wear. The light spectrum in the ward was assessed prior to commencing the RCT and is well-matched to what has been shown in laboratory settings to minimally suppress melatonin."
16413530|NCT03347695|Procedure|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure|Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
16413531|NCT03347110|Drug|Bimekizumab|Bimekizumab at a prespecified dose.
16413373|NCT03788993|Other|Normal light condition|"The other half of the unit (20 patient rooms and their corresponding bathrooms and common areas) have ordinary indoor light installed (Glamox, Norway). This has a 3000K color temperature. The light is dimmed to 20% of max in the night, similar to the blue-depleted condition.
~The light in the normal light condition and the blue-depleted light condition have similar levels of photopic lux throughout the 24h cycle, but different levels of melanopic lux between 1830h and 0700h."
16413374|NCT03788980|Procedure|Carotid endarterectomy|Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)
16413375|NCT03788980|Diagnostic Test|Mini Mental Status Examination|Short questionnaire used to diagnose cognitive dysfunction
16413376|NCT03786640|Radiation|3T MRI scan|A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.
16413377|NCT03785574|Other|Follow up|the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
16413378|NCT03785574|Drug|chemotherapy|First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
16413379|NCT03783026|Drug|CC-10004|CC-10004
16413380|NCT03781986|Drug|APG-115|APG-115 at 150mg (or lower, if dose is reduced) is taken orally every other day through day 13 of each cycle. Cycle length 21 days.
16413381|NCT03781986|Drug|Carboplatin|Carboplatin is given IV at AUC=4.5 on day 1 of each cycle. Cycle length 21 days.
16413382|NCT03776071|Drug|Enzastaurin Hydrochloride|mg
16413383|NCT03776071|Other|Placebo|mg
16413384|NCT03776071|Drug|Temozolomide|mg/m^2
16413385|NCT03776071|Radiation|Radiotherapy|Gy
16413386|NCT03759808|Behavioral|Psychological Intervention|Psychological treatment protocol designed to treat anxiety and avoidance in an adolescent/young adult population. The focus of treatment will be to address cognitive and behavioral factors associated with prolonged symptoms. Cognitive factors that may be addressed include, but are not limited to, catastrophizing, black or white thinking, and false expectations. Behavior factors that may be addressed include, but are not limited to, avoidance, relaxation, and behavioral activation. The psychological intervention is also designed to help reduce psychophysiological arousal associated with anxiety and stress. Participants will also be taught controlled shallow breathing exercises designed to normalize the ratio of sympathetic/parasympathetic activity.
16413387|NCT03759366|Drug|Eculizumab|Eculizumab will be administered by IV infusion.
16413388|NCT03758274|Behavioral|CBT by Phone to Promote Treatment|Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
16413389|NCT03758274|Other|Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment|The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.
16413390|NCT03755934|Biological|MEDI7352|MEDI7352
16413391|NCT03755934|Other|Placebo|Placebo
16413392|NCT03755713|Drug|ASP0892|Intradermal
16413393|NCT03755713|Drug|Placebo|Intradermal; normal saline solution
16413394|NCT03739775|Procedure|Blood sampling|Patients will have a blood draw at each visit to the hospital and at least 6 months (+/- 1 month) intervals.
16413395|NCT03737981|Drug|Ibrutinib|Given PO
16413396|NCT03737981|Biological|Obinutuzumab|Given IV
16413397|NCT03737981|Other|Observation|Undergo observation
16413398|NCT03737981|Drug|Venetoclax|Given PO
16413399|NCT03733067|Drug|abatacept|Double-blind, placebo-controlled, intra-patient dose-escalation trial of abatacept for treating cytopenia in CTLA4 deficiency. Abatacept or placebo will be administered for 3 doses over 30 days, followed by 5 more months of administration at double the initial dose. If the participant s hematologic parameters normalize at Day 120 or onwards, the investigator may taper or discontinue concomitant medications aimed at treating cytopenia.
16413400|NCT03733067|Other|Placebo|Saline packaged identically to abatacept, with volume matching that of the abatacept dosing by weight, and will be administered via IV infusion identically to abatacept
16413401|NCT03732209|Behavioral|Episodic future thinking|Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
16413402|NCT03732209|Behavioral|Control Thinking|Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
16413403|NCT03713632|Drug|Secukinumab|Secukinumab 300mg every 2 or every 4 weeks
16413404|NCT03713632|Drug|Placebo|Placebo 300mg every 2 or every 4 weeks
16413405|NCT03701308|Drug|Cytarabine|Given IV
16413406|NCT03701308|Drug|Daunorubicin|Given IV
16413407|NCT03701308|Drug|Uproleselan|Given IV
16413408|NCT03698019|Biological|Pembrolizumab|Given IV
16413409|NCT03698019|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16413410|NCT03696797|Procedure|Blood Donation|Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed.
16413411|NCT03696797|Procedure|Sham Blood Donation|Participants will have a needle inserted their arm, however, no blood will be drawn.
16413412|NCT03690206|Drug|glepaglutide|Glucagon-Like Peptide-2 (GLP-2) analog
16413413|NCT03690206|Drug|Placebo|Placebo for glepaglutide
16413532|NCT03345784|Drug|Adavosertib|Given PO
16413533|NCT03345784|Drug|Cisplatin|Given IV
16413534|NCT03345784|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16413535|NCT03345160|Drug|Peanut Flour|open label oral immunotherapy
16413536|NCT03341962|Drug|IMU-838|IMU-838 tablet
16413414|NCT03689920|Device|Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System|The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
16413415|NCT03687957|Drug|rhIL-7-hyFc|-Given by intramuscular injection
16413416|NCT03687957|Drug|Placebo|-Given by intramuscular injection
16413417|NCT03687957|Drug|Temozolomide|-Standard of care
16413418|NCT03687957|Radiation|Radiation therapy|-Standard of care
16413419|NCT03687957|Procedure|Blood sample|"Week 1 (prior to the 1st dose of rhIL-7-hyFc)
~Week 2 (one week after rhIL-7-hyFc)
~Week 3 (two weeks after rhIL-7-hyFc)
~Week 4 (three weeks after rhIL-7-hyFc)
~Week 13 (prior to the 2nd dose of rhIL-7-hyFc)
~Week 14 (one week after rhIL-7-hyFc )
~At the time of tumor progression"
16413420|NCT03687710|Behavioral|Multidomain precision medicine intervention|Participants will receive individualized evidence-based multidomain interventions (education, pharmacologic, non-pharmacologic) in the setting of routine outpatient clinical care.
16413421|NCT03678545|Drug|Dupilumab (blinded)|Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.
16413422|NCT03678545|Drug|Placebo (blinded)|Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.
16413423|NCT03678545|Drug|Dupilumab (open-label)|After completing 6 doses of blinded study drug (dupilumab or placebo), participants can continue into the open-label portion of the study, in which all subjects will receive 12 doses (every 2 weeks for 24 weeks) of dupilumab.
16413424|NCT03662659|Biological|BMS-986213|Relatlimab + Nivolumab specified dose on specified days
16413425|NCT03662659|Biological|Nivolumab|Specified dose on specified days
16413426|NCT03662659|Drug|XELOX|Oxaliplatin + capecitabine
16413427|NCT03662659|Drug|FOLFOX|Oxaliplatin + leucovorin + fluorouracil
16413428|NCT03662659|Drug|SOX|Oxaliplatin + tegafur/gimeracil/oteracil potassium
16413429|NCT03660826|Drug|Capivasertib|Given PO
16413430|NCT03660826|Drug|Cediranib|Given PO
16413431|NCT03660826|Drug|Cediranib Maleate|Given PO
16413432|NCT03660826|Biological|Durvalumab|Given IV
16413433|NCT03660826|Drug|Olaparib|Given PO
16413434|NCT03658772|Drug|grapiprant|Cohort 1 will be treated for 1 week with oral grapiprant as a single agent, followed by 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab.
16413435|NCT03658772|Drug|grapiprant and pembrolizumab|Cohort 2 will be administered 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab.
16413436|NCT03649321|Drug|Bemcentinib|200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
16413437|NCT03649321|Drug|Nab-paclitaxel|25 mg/m^2 Day 1 /8 every 21 days or 28 days.
16413438|NCT03649321|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 Day 1 /8 every 21 days or 28 days
16413439|NCT03649321|Drug|Cisplatin|Cisplatin 25 mg/m^2 Day 1 /8 every 21 days
16413440|NCT03643224|Device|Radiofrequency Ablation|A procedure will be performed using a radiofrequency ablation catheter.
16413441|NCT03635424|Device|Medtronic TAVR Systems|Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
16413442|NCT03619551|Drug|Busulfan|Randomization between low and medium doses of busulfan for TCR αβ+/CD19+ depleted haploidentical related and unrelated donor HCT.
16413443|NCT03619551|Device|Cell processing for TCRαβ+/CD19+ depletion|T-cells and B-cells will be removed from the stem cells collected from the donor by an investigational process called alpha-beta CD3+/CD19+ t-cell depletion using a device called CliniMACS® prior to recipient infusion, hopefully minimizing the risk of significant graft vs. host disease (GVHD) or lymphoproliferative disorder.
16413444|NCT03616587|Drug|AZD9833|Part A: AZD9833 monotherapy dose escalation.
16413445|NCT03616587|Drug|AZD9833|Part B: AZD9833 monotherapy expansion.
16413446|NCT03616587|Drug|AZD9833 with palbociclib|Part C: AZD9833 in combination with palbociclib dose escalation
16413447|NCT03616587|Drug|AZD9833 with palbociclib|Part D: AZD9833 in combination with palbociclib expansion
16413448|NCT03616587|Drug|AZD9833 with everolimus|Part E: AZD9833 in combination with everolimus dose escalation
16413449|NCT03616587|Drug|AZD9833 with everolimus|Part F: AZD9833 in combination with everolimus dose expansion
16413450|NCT03616587|Drug|AZD9833 with abemaciclib|Part G: AZD9833 in combination with abemaciclib
16413451|NCT03616587|Drug|AZD9833 with abemaciclib|Part H: AZD9833 in combination with abemaciclib dose expansion
16413452|NCT03616587|Drug|AZD9833 with capivasertib|Part I: AZD9833 in combination with capivasertib dose escalation
16413453|NCT03616587|Drug|AZD9833 with capivasertib|Part J: AZD9833 in combination with capivasertib dose expansion
16413454|NCT03601442|Biological|CTL019|CTL019
16413455|NCT03599713|Drug|Retifanlimab|INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.
16413456|NCT03589846|Device|Grass S88 Muscle Stimulator|The Grass S88 nerve and muscle stimulator is a widely-used tool in electromyography and nerve conduction studies. Under anesthesia, fine-wire electrodes will be placed into the right genioglossus muscle (in the floor of the mouth) and the right palatoglossus muscle (in the anterior tonsillar pillar).
16413457|NCT03587493|Other|BLOOD SAMPLE ANALYSIS|Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry
16413458|NCT03581292|Radiation|Radiation Therapy|Undergo radiation therapy
16413459|NCT03581292|Drug|Temozolomide|Given PO
16413460|NCT03581292|Drug|Veliparib|Given PO
16413461|NCT03580369|Biological|Ligelizumab|Liquid in vial
16413462|NCT03580369|Biological|Omalizumab|Lyophilized powder for solution in vial
16413463|NCT03580369|Other|Placebo|Liquid in vial
16413464|NCT03580356|Biological|Ligelizumab|Liquid in vial
16413465|NCT03580356|Biological|Omalizumab|Lyophilized powder for solution in vial
16413466|NCT03580356|Other|Placebo|Liquid in vial
16413467|NCT03574545|Biological|ianalumab|Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
16413468|NCT03572530|Drug|5-Azacytidine (5-AZA) group 1|"5-AZA (12 mg) will be prepared in preservative-free normal saline to a total volume of 1.2ml. 5-AZA will be infused over a minimum of 30 seconds. 5-AZA will be followed by a 1 ml preservative-free normal saline flush over a minimum of 30 seconds.
~Patients will receive two, three, or four 5-AZA infusions per week depending on the dosing algorithm (see below). We refer to these dosing schedules as dose 1, 2, or 3.
~Patients assigned to dose 1 will receive two 5-AZA infusions per week (typically Monday and Thursday but may be given on other days based upon logistical considerations) for 8 consecutive weeks."
16413469|NCT03572530|Drug|5-Azacytidine (5-AZA) group 2|"5-AZA (12 mg) will be prepared in preservative-free normal saline to a total volume of 1.2ml. 5-AZA will be infused over a minimum of 30 seconds. 5-AZA will be followed by a 1 ml preservative-free normal saline flush over a minimum of 30 seconds.
~Patients will receive two, three, or four 5-AZA infusions per week depending on the dosing algorithm (see below). We refer to these dosing schedules as dose 1, 2, or 3.
~Patients assigned to dose 2 will receive three 5-AZA infusions per week (typically Monday, Wednesday, and Friday but may be given on other days based upon logistical considerations) for 8 consecutive weeks."
16413470|NCT03572530|Drug|5-Azacytidine (5-AZA) group 3|"5-AZA (12 mg) will be prepared in preservative-free normal saline to a total volume of 1.2ml. 5-AZA will be infused over a minimum of 30 seconds. 5-AZA will be followed by a 1 ml preservative-free normal saline flush over a minimum of 30 seconds.
~Patients will receive two, three, or four 5-AZA infusions per week depending on the dosing algorithm (see below). We refer to these dosing schedules as dose 1, 2, or 3.
~Patients assigned to dose 3 will receive four 5-AZA infusions per week (on any 4 weekdays based upon logistical considerations) for 8 consecutive weeks."
16413471|NCT03567980|Drug|Crisaborole|Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
16413472|NCT03549715|Drug|Durvalumab|1500 mg IV D1 every 28 days (2 doses for each patient)
16413473|NCT03549715|Drug|Tremelimumab|75 mg IV D1 every 28 days ((2 doses for each patient)
16413474|NCT03549715|Drug|MVAC Protocol|"Methotrexate 30 mg/m2 IV D1
~Vinblastine 3 mg/m2 IV D1
~Adriamycin (doxorubicin) 30 mg/m2 IV D1
~Cisplatin 70 mg/m2 IV D1"
16413475|NCT03539432|Drug|Gemfibrozil 600 MG|Gemfibrozil capsules (600 mg) taken twice per day
16413476|NCT03539432|Drug|Placebo oral capsule|Microcrystalline cellulose powder packaged in capsules identical to the experimental medication
16413477|NCT03538652|Behavioral|JITAI|Just-In-Time Adaptive Intervention delivered via smartphone app
16413478|NCT03538652|Other|Placebo|Placebo
16413479|NCT03532295|Drug|Epacadostat|-All BID doses will be taken in the morning and evening, approximately 12 hours apart
16413480|NCT03532295|Drug|Bevacizumab|-The first infusion will be over the course of 90 minutes; if tolerated, the second infusion will be over the course of 60 minutes; if tolerated, all subsequent infusions will be over 30 minutes
16413481|NCT03532295|Radiation|Radiation therapy|-The gross tumor maximum diameter (to be irradiated) to be </= 6 cm in the first 6 patients. If more than 1 target is irradiated, then the sum of all the target maximum diameters should be </= 6 cm. No more than 3 separate targets for RT is allowed.
16413482|NCT03532295|Procedure|Peripheral blood draw|"Baseline (prior to administration of any study treatment)
~Before initiation of RT (up to 7 days prior to start of RT; may be on the same day as RT before RT treatment)
~At the end of RT and/or Cycle 2 Day 1 prior to administration of INCMGA00012 with our without epacadostat
~Cycle 3 Day 1 prior to administration of INCMGA00012 with or without epacadostat (+/- 7 days)
~Cycle 5 Day 1 prior to administration of INCMGA00012 with our without epacadostat (+/- 7 days)
~Time of disease progression"
16413483|NCT03526861|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
16413484|NCT03526861|Drug|Placebos|Placebo contains the same excipients in the same concentration only lacking tralokinumab.
16413485|NCT03526250|Other|Laboratory Biomarker Analysis|Correlative studies
16413486|NCT03526250|Drug|Palbociclib|Given PO
16413487|NCT03526250|Other|Pharmacological Study|Correlative studies
16413488|NCT03510988|Diagnostic Test|Hybrid breast FDG PET/MRI|Hybrid breast FDG PET/MRI
16413489|NCT03507647|Behavioral|Mindfulness Based Cognitive Therapy|"MBCT is a manualised group skills-training program (Segal, Williams & Teasdale 2012) consisting of eight weekly sessions of 2.5 hours, plus one day of silent practice. The program includes both formal and informal meditation exercises. Cognitive techniques that are part of the program are education, monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention plan.
~The MBCT treatment will be adapted to address the needs of patients with a bipolar disorder. A few examples of these adaptations are: (more) psychoeducation about manic symptoms in addition to the psychoeduction about depression; introducing the 3-minute breathing space earlier in the programme and more often during sessions, especially when strong emotions are present; repeatedly bringing the focus to self-care; and making use of the mindful movement (yoga) exercises more frequently."
16413490|NCT03507647|Other|Usual Care|Usual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse). Usual care will not be restricted, except for proscribing high-frequency psychological interventions such as (group) cognitive behavioral therapy, for practical and methodological reasons.
16413491|NCT03494933|Procedure|CRT-P implantation|Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-P device.
16413492|NCT03494933|Procedure|CRT-D implantation|Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-D device.
16413493|NCT03493958|Other|SHUTi Control|The control group of the study will be standard insomnia education/monitor only (insomnia education web-based program that participants access and read at their own pace contains no customization of program based on sleep diary responses). Participants in the control group are given educational information (like they might see on WebMD or National Sleep Foundation websites), but are left to apply it themselves.
16413494|NCT03493958|Behavioral|SHUTi|The SHUTi program is an automated, interactive, internet- based intervention based on well-established face-to- face CBT-I components including sleep restriction, stimulus control, sleep hygiene, cognition
16413539|NCT03324581|Drug|Atomoxetine|Atomoxetine gelatin capsules
16413495|NCT03489382|Other|Smartphone Assisted PST|"Emergency Departments randomized to the study intervention will receive:
~Staff education incorporated into regular teaching rounds at least twice a year about the management of self-harm in the Emergency Department. This will include the dissemination of guidelines on how to ask questions about suicide, assessment of suicide risk, the creation of a management plan and how to refer patients to local mental health resources, including the study.
~Written materials developed by service users for men who self-harm that outline local resources, distress centre helplines, and follow-up arrangements.
~The option to refer men who self-harm to a service that will deliver smartphone-assisted PST specifically designed for men."
16413496|NCT03483246|Drug|Fecal Microbiota Transplantation (FMT)|"The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit.
~After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
~The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum."
16413497|NCT03483246|Drug|Sham-transplantation Placebo|"The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit.
~After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
~The patient will then sham transplantation (FMT vehicle) in the cecum."
16413498|NCT03481842|Biological|Linifanib|in a minimally sufficient therapeutic dose
16413499|NCT03481842|Drug|BIBW2992|in a minimally sufficient therapeutic dose
16413500|NCT03481842|Drug|Axitinib|in a minimally sufficient therapeutic dose
16413501|NCT03474107|Drug|Enfortumab Vedotin|Intravenous infusion
16413502|NCT03474107|Drug|Docetaxel|Intravenous infusion
16413503|NCT03474107|Drug|Vinflunine|Intravenous infusion
16413504|NCT03474107|Drug|Paclitaxel|Intravenous infusion
16413505|NCT03466346|Drug|Fluoxetine|Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.
16413506|NCT03466346|Behavioral|Interpersonal Psychotherapy|PT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.
16413507|NCT03458871|Device|4-week TTNS home-based protocol|"4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.
~In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
~Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used."
16413508|NCT03449706|Drug|Early combination anti-retroviral treatment|Patients are started on treatment to supress the HIV virus in the phase of acute seroconversion.
16413509|NCT03436745|Drug|Zolpidem|In men with prostate cancer, males (precastration, n=8-10) will receive oral zolpidem in the form of a 5 mg tablet. Blood samples will be collected for pharmacokinetic analysis at pre-dose and 0.5, 1, 2, 4, and 8-hours post-dose. This cohort of men will then undergo androgen deprivation therapy with standard doses of goserelin. When castrate testosterone levels reach <50 ng/dL (postcastration), they will receive another 5 mg single dose of zolpidem followed by 8-hr PK evaluation of zolpidem and its metabolites. Normal healthy females (n=5-8) will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hr PK evaluation of zolpidem and its metabolites. Blood samples will be collected for PK analysis at predose and 0.5, 1, 2, 4, and 8-hours post-dose.
16413510|NCT03425539|Drug|Lucerastat|Hard gelatin capsules containing 250 mg of lucerastat and inactive excipients; 1000 mg (4 capsules) b.i.d.; dose adjusted for renal function.
16413511|NCT03425539|Drug|Placebo|Placebo capsules are identical in appearance to the lucerastat capsules, and contain inactive excipients; 4 capsules b.i.d.; dose adjusted for renal function.
16413512|NCT03410017|Other|Functional Listening Index|Functional Listening Index questionnaire to assess acquisition of listening skills.
16413513|NCT03403634|Drug|Celecoxib|Given PO
16413514|NCT03403634|Other|Laboratory Biomarker Analysis|Correlative studies
16413515|NCT03403634|Biological|Recombinant Interferon Alfa-2b|Given IV
16413516|NCT03403634|Drug|Rintatolimod|Given IV
16413517|NCT03397719|Behavioral|Treatment Condition|This group will receive three hours of parent coaching per week, one hour per week will involve feedback on parent usage of coached strategies based on parent recorded interactions with their children.
16413518|NCT03397719|Behavioral|Control Group|This group will receive in-vivo parent coaching three hours per week.
16413519|NCT03394365|Biological|tabelecleucel|Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
16413520|NCT03388294|Behavioral|Parents and Infants Engaged|A novel in-home parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other NDs on the one hand, and parent responses to infant cues on the other hand, using live coaching and video feedback methods.
16413521|NCT03381274|Biological|MEDI9447|Subjects will receive MEDI9447 in combination with osimertinib or AZD4635 until disease progression
16413522|NCT03381274|Drug|Osimertinib|Subjects will receive osimertinib in combination with MEDI9447 until disease progression
16413523|NCT03381274|Drug|AZD4635|Subjects will receive AZD4635 in combination with MEDI9447 until disease progression
16413524|NCT03375320|Drug|Cabozantinib S-malate|Given PO
16413525|NCT03375320|Other|Laboratory Biomarker Analysis|Correlative studies
16413526|NCT03375320|Other|Placebo Administration|Given PO
16413527|NCT03375320|Other|Quality-of-Life Assessment|Ancillary studies
16413528|NCT03348995|Device|Bridge-Enhanced ACL Restoration (BEAR)|In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.
16413540|NCT03324581|Drug|Placebo|OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
16413541|NCT03298451|Drug|Durvalumab|Durvalumab IV (intravenous infusion).
16413542|NCT03298451|Drug|Tremelimumab (Regimen 1)|Tremelimumab IV (intravenous infusion).
16413543|NCT03298451|Drug|Tremelimumab (Regimen 2)|Tremelimumab IV (intravenous infusion).
16413544|NCT03298451|Drug|Sorafenib|Sorafenib, as per standard of care
16413545|NCT03298451|Drug|Durvalumab (Regimen 1)|Durvalumab IV (intravenous infusion).
16413546|NCT03298451|Drug|Durvalumab (Regimen 2)|Durvalumab IV (intravenous infusion).
16413547|NCT03293563|Procedure|Radical nephrectomy versus partial nephrectomy (according surgeon judgement)|
16413548|NCT03258593|Drug|Durvalumab|Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that patient is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost.
16413549|NCT03258593|Drug|Vicineum|Vicineum is administered in a 12 week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30mg in 50 mL of saline.
16413550|NCT03257969|Behavioral|The DROP program of pharmaceutical interventions|Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions.
16413551|NCT03257969|Behavioral|Standard of care|In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.
16413552|NCT03241030|Drug|Sucralfate|Will receive 20mg/kg/dose up to 1 gram.
16413553|NCT03241030|Other|Placebo|Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
16413554|NCT03241030|Drug|Acetaminophen|All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
16413555|NCT03241030|Drug|Ibuprofen|All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
16413556|NCT03237858|Device|HeartLogic ON|Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
16413557|NCT03237858|Device|HeartLogic OFF|Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
16413558|NCT03237819|Drug|Sulfate, Magnesium|"Magnesium sulphate will be administered at a dose of 6g over 20 min intravenously followed by a continuous infusion of 6g / 24h for 3 days.
~For each day of treatment, 4 ampoules of 10 ml will be distributed to the nurse in charge of the patient (4 ampoules of 1,5g of magnesium sulfate)"
16413559|NCT03237819|Drug|Placebo - Concentrate|For each day of treatment, 4 ampoules of 10 ml will be distributed to the nurse in charge of the patient (4 ampoules of glucose 5% as placebo)
16413560|NCT03236077|Behavioral|Fit and Fab|participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions
16413561|NCT03233204|Drug|Olaparib|Given PO
16413562|NCT03232073|Drug|Ponesimod|Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15
16413563|NCT03220035|Other|Laboratory Biomarker Analysis|Correlative studies
16413564|NCT03220035|Drug|Vemurafenib|Given PO
16413565|NCT03217422|Biological|VAY736|VAY736
16413566|NCT03217422|Other|Placebo|Placebo control with conversion to active VAY736
16413567|NCT03213704|Drug|Larotrectinib|Given PO or via nasogastric- or gastric-tube
16413568|NCT03213704|Drug|Larotrectinib Sulfate|Given PO or via nasogastric- or gastric-tube
16413569|NCT03213678|Other|Laboratory Biomarker Analysis|Correlative studies
16413570|NCT03213678|Other|Pharmacological Study|Correlative studies
16413571|NCT03213678|Drug|Samotolisib|Given PO
16413572|NCT03213652|Drug|Ensartinib|Given PO
16413573|NCT03213652|Other|Laboratory Biomarker Analysis|Correlative studies
16413574|NCT03213652|Other|Pharmacological Study|Correlative studies
16413575|NCT03210714|Drug|Erdafitinib|Given PO
16413576|NCT03210714|Other|Laboratory Biomarker Analysis|Correlative studies
16413577|NCT03210714|Other|Pharmacological Study|Correlative studies
16413578|NCT03207958|Drug|Belimumab|-Given over 1 hour
16413579|NCT03205956|Drug|Levodopa|"At least 1 hour after 200mg carbidopa p.o., each subject will receive an intravenous solution of levodopa in saline at a rate based on age and body mass according to the final dose described in Black et al 2003.The total dose for a 70-year-old, 70kg subject will be approximately 65mg.
~Subjects with untreated PD will then take 6 ± 1 weeks of clinically dosed oral carbidopa-levodopa tablets for clinical purposes and then repeat the carbidopa plus intravenous levodopa dose as above."
16413580|NCT03199885|Drug|Atezolizumab|Given IV
16413581|NCT03199885|Drug|Docetaxel|Given IV
16413582|NCT03199885|Drug|Paclitaxel|Given IV
16413583|NCT03199885|Biological|Pertuzumab|Given IV
16413584|NCT03199885|Other|Placebo Administration|Given IV
16413585|NCT03199885|Other|Quality-of-Life Assessment|Ancillary studies
16413586|NCT03199885|Biological|Trastuzumab|Given IV
16413587|NCT03198416|Device|High-resolution pharyngeal manometry catheter|The system is a widely-used tool in gastrointestinal medicine for high resolution mapping of pressures within tubular organs.The device will be deployed trans-nasally into the pharyngeal and esophageal lumen in exactly the same fashion as is done for motility studies.
16413588|NCT03186209|Biological|Benralizumab|Benralizumab subcutaneously on study week 0 until study week 40 inclusive.
16413589|NCT03186209|Biological|Placebo|Placebo subcutaneously on study week 0 until study week 40 inclusive.
16413590|NCT03183609|Other|Gluten Flour in Protein Shake|15 Grams Gluten Flour BID
16413591|NCT03183609|Other|Rice Flour in Protein Shake|15 Grams Rice Flour BID
16413592|NCT03181971|Behavioral|Water First|The Water First intervention consists of increased access to safe and appealing drinking water in schools, school-wide promotion to increase students' intake of water, and education directed to 4th grade students and their families to increase intake of water.
16413593|NCT03173937|Biological|CordIn|Stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic umbilical/unrelated cord blood (UCB) cells. CordIn(TM) comprises: 1) cord blood-derived ex vivo expanded CD133+ cells (CordIn(TM) cultured fraction (CF)); and 2) the non-cultured cell fraction (CD133-) of the same CBU (CordIn(TM) Non-cultured Fraction (NF)). Both fractions, i.e. CordIn(TM) CF and CordIn(TM) NF are kept frozen until they are infused on the day of transplantation.
16413594|NCT03167437|Drug|Vorinostat|It is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patient with cutaneous T-cell lymphoma (CTCL) who have progress, persistent or recurrent disease on or following two systemic therapies. We are using this drug off label for the purpose of this study
16413595|NCT03167437|Drug|Ustekinumab|Ustekinumab inhibits the bioactivity of human IL-12 and IL- 23 by preventing these cytokines from binding to the IL- 12Rbeta1 receptor protein expressed on the surface of immune cells. It is FDA approved for the treatment of adult patients with active psoriatic arthritis and more recently, in September 2016, ustekinumab has been approved for the treatment of patients with Crohn s disease.
16413596|NCT03164616|Drug|Durvalumab|IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
16413597|NCT03164616|Drug|Tremelimumab|IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
16413598|NCT03164616|Drug|Abraxane + carboplatin|Standard of care chemotherapy (squamous and non-squamous patients)
16413599|NCT03164616|Drug|Gemcitabine + cisplatin|Standard of care chemotherapy (squamous patients only)
16413600|NCT03164616|Drug|Gemcitabine + carboplatin|Standard of care chemotherapy (squamous patients only)
16413601|NCT03164616|Drug|Pemetrexed + carboplatin|Standard of care chemotherapy (non-squamous patients only)
16413602|NCT03164616|Drug|Pemetrexed + cisplatin|Standard of care chemotherapy (non-squamous patients only)
16413603|NCT03155620|Procedure|Biopsy|Undergo biopsy
16413604|NCT03155620|Procedure|Biospecimen Collection|Undergo collection of blood
16413605|NCT03155620|Drug|Ensartinib|Given PO
16413606|NCT03155620|Drug|Erdafitinib|Given PO
16413607|NCT03155620|Other|Laboratory Biomarker Analysis|Undergo molecular analysis
16413608|NCT03155620|Drug|Larotrectinib|Given PO or via nasogastric- or gastric-tube
16413609|NCT03155620|Procedure|Mutation Carrier Screening|Undergo tumor tissue mutation screening
16413610|NCT03155620|Drug|Olaparib|Given PO
16413611|NCT03155620|Drug|Palbociclib|Given PO
16413612|NCT03155620|Other|Pharmacological Study|Correlative studies
16413613|NCT03155620|Drug|Samotolisib|Given PO
16413614|NCT03155620|Drug|Selpercatinib|Given PO
16413615|NCT03155620|Drug|Selumetinib Sulfate|Given PO
16413616|NCT03155620|Drug|Tazemetostat|Given PO
16413617|NCT03155620|Drug|Tipifarnib|Given PO or via nasogastric or gastric tube
16413618|NCT03155620|Drug|Ulixertinib|Receive PO
16413619|NCT03155620|Drug|Vemurafenib|Given PO
16413620|NCT03151811|Drug|Melflufen|Intravenous infusion
16413621|NCT03151811|Drug|Pomalidomide|Oral capsules
16413622|NCT03151811|Drug|Dexamethasone|Oral tablets
16413623|NCT03149029|Drug|Pembrolizumab|Pembrolizumab is a type of antibody that inhibits the cancer cell growth
16413624|NCT03149029|Drug|Dabrafenib|Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating
16413625|NCT03149029|Drug|Trametinib|Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
16413626|NCT03139916|Drug|Temozolomide|Temozolomide causes cell death and shrinks and kills the cancer cells
16413627|NCT03139916|Drug|Bavituximab|Bavituximab may activate (cause) the immune system to attack the cancer cells
16413628|NCT03139916|Radiation|Radiation|Radiation causes cell death and shrinks and kills the cancer cells.
16413629|NCT03128957|Device|IVOS cerebral oximeter|Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.
16413630|NCT03128957|Device|Licox cerebral oxygenation monitor|Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.
16413631|NCT03128957|Other|Cerebral oxygenation|Measuring cerebral oxygenation with varying ventilation strategy
16413632|NCT03120949|Drug|Olokizumab 64 mg SC q4w|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
16413633|NCT03120949|Drug|Olokizumab 64 mg SC q2w|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
16413634|NCT03092518|Procedure|Surgery|Heated Intraperitonial Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate
16413635|NCT03092518|Drug|Cisplatin|Cisplatin (90 mg/m2) will be administered via circuit to the peritoneal cavity
16413636|NCT03092518|Drug|Mitomycin C|Mitomycin C 10 mg/m2 will be administered via circuit to the peritoneal cavity
16413637|NCT03092518|Drug|Sodium Thiosulfate|Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.
16413638|NCT03084471|Biological|MEDI4736 (Durvalumab)|A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC).
16413692|NCT02873338|Drug|Idarubicin|12 mg/m2/day by slow (10 to 15 minutes) IV injection daily on days 1, 2 and 3 of induction therapy, and on days 1 and 2 of re-induction therapy
16413639|NCT03084471|Biological|MEDI4736 (Durvalumab) + Tremelimumab|"Durvalumab: A human mAb of IgG 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on IC.
~Tremelimumab: A human Ig G2 mAb that completely blocks the interaction of human CTLA-4 (cluster of differentiation [CD]152) with CD80 and CD86 and increase release of cytokines (interleukin [IL]-2 and interferon [IFN]-γ) from human T cells, peripheral blood mononuclear cells and whole blood."
16413640|NCT03073603|Drug|Discontinuation of disease modifying therapy|Participants who will discontinue their current MS drug. No other changes to their treatment occur.
16413641|NCT03073603|Drug|Standard of Care|Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease.
16413642|NCT03069521|Device|EndoArt® Artificial Endothelial Layer|device is intended for use as an endothelial kearatoprosthesis
16413643|NCT03057431|Drug|Placebo oral capsule|Once daily for 3 years
16413644|NCT03057431|Drug|12.5 mg hydrochlorothiazide|Once daily for 3 years
16413645|NCT03057431|Drug|25.0 mg hydrochlorothiazide|Once daily for 3 years
16413646|NCT03057431|Drug|50.0 mg hydrochlorothiazide|Once daily for 3 years
16413647|NCT03034018|Drug|suvorexant|10-20 mg taken at bedtime for four weeks
16413648|NCT03034018|Drug|placebo|placebo taken at bedtime for four weeks
16413649|NCT03027388|Drug|LB-100|LB-100 will be infused over 2 hours via IV infusion 2 to 4 hours before surgery. The dose established from a Phase I study will be 2.33 mg/m2.
16413650|NCT03019497|Behavioral|Specific Modules|Educational session about a specific related problem
16413651|NCT03019497|Behavioral|Cognitive behavioral therapy|PTSD of participants in both conditions will be addressed with cognitive-behavioral intervention strategies. These strategies are: (a) psychoeducation on PTSD, (b) anxiety management training, (c) restructuring irrational thoughts, (d) imaginative and / or in vivo exposure to memories and situations avoided, and (e) strategies for the prevention of relapse.
16413652|NCT03019003|Drug|Oral Decitabine|Hypomethylating agent
16413653|NCT03019003|Drug|Durvalumab|anti-PD-L1
16413654|NCT03011333|Drug|HTX-011|HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.
16413655|NCT03011333|Drug|Bupivacaine HCl without epinephrine|Bupivacaine HCl without epinephrine, 50 mg via nerve block.
16413656|NCT03011333|Drug|Saline Placebo|Saline placebo via nerve block.
16413657|NCT03010527|Drug|Bimekizumab|Subjects will receive bimekizumab injections every four weeks (Q4W)
16413658|NCT03010527|Other|Placebo|Subjects will receive Placebo injections every four weeks (Q4W)
16413659|NCT03003962|Drug|Durvalumab (MEDI4736)|Anti-PD-L1 monoclonal Antibody monotherapy
16413660|NCT03003962|Drug|Paclitaxel + carboplatin|Chemotherapy Agents
16413661|NCT03003962|Drug|Gemcitabine + cisplatin|Chemotherapy Agents
16413662|NCT03003962|Drug|Gemcitabine + carboplatin|Chemotherapy Agents
16413663|NCT03003962|Drug|Pemetrexed + cisplatin|Chemotherapy Agent
16413664|NCT03003962|Drug|Pemetrexed + carboplatin|Chemotherapy Agent
16413665|NCT02997228|Drug|Atezolizumab|Given IV
16413666|NCT02997228|Biological|Bevacizumab|Given IV
16413667|NCT02997228|Drug|Fluorouracil|Given IV
16413668|NCT02997228|Drug|Leucovorin|Given IV
16413669|NCT02997228|Drug|Oxaliplatin|Given IV
16413670|NCT02997228|Other|Quality-of-Life Assessment|Ancillary studies
16413671|NCT02997228|Other|Questionnaire Administration|Ancillary studies
16413672|NCT02987803|Other|Data|The tool displays star ratings of hospitals on how labor-friendly they are. The star ratings (1 through 5) are based on hospital-level cesarean delivery rates. The data comes from The Leapfrog Group and is supplemented by publicly available state data. The data displayed will be customized to the users geographic location.
16413673|NCT02980341|Drug|U3-1402|U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)
16413674|NCT02960516|Device|MRI of 3.0T|Diffusion Tensor Testing for peripheral nerve monitoring
16413675|NCT02956603|Other|Fine wire EMG electrodes|Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate
16413676|NCT02951130|Drug|Milrinone|The study intervention is an intravenous infusion of milrinone or placebo
16413677|NCT02951130|Drug|Placebo (5% Dextrose)|The study intervention is an intravenous infusion of milrinone or placebo
16413678|NCT02950012|Dietary Supplement|OPTI-BIOME™ Bacillus subtilis MB40|
16413679|NCT02950012|Other|Placebo|
16413680|NCT02924129|Device|Evoke Spinal Cord Stimulator (SCS) System|Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
16413681|NCT02921893|Drug|Dexamethasone|Given PO
16413682|NCT02921893|Drug|Ixazomib Citrate|Given PO
16413683|NCT02921893|Drug|Lenalidomide|Given PO
16413684|NCT02921893|Other|Questionnaire Administration|Ancillary studies
16413685|NCT02906397|Drug|Galunisertib 150mg by mouth twice a day|on days 1-14 of 28 day cycles
16413686|NCT02906397|Radiation|Stereotactic Body Radiotherapy (SBRT)|18GY delivered in one fraction between C1D15 and C1D28
16413687|NCT02905110|Drug|Methotrexate|Methotrexate 4 mg into fourth ventricle of the brain via the Ommaya Reservoir 2 days a week for 6 weeks. Each patient will have 12 infusions.
16413688|NCT02905110|Drug|Etoposide|Etoposide 1 mg into fourth ventricle of the brain via the Ommaya Reservoir 5 days a week for weeks 1, 3, and 5. Each patient will have 15 infusions.
16413689|NCT02905110|Procedure|Ommaya Reservoir|Surgical catheter placement into the fourth ventricle of the brain
16413690|NCT02903992|Radiation|Dual-energy X-ray absorptiometry (DXA)|Patients with at least one Fried criteria will have a Dual-energy X-ray absorptiometry (DXA) to measure lean muscle mass adjusted for body mass index. As part of the usual care in the Frailty Clinic patients will also have a clinical examination, a standard biological sample (requiring 15 ml of blood); an evaluation of the cognitive and functional performances, of their medico-economic situation and lifestyle.
16413691|NCT02873338|Drug|CX-01|4 mg/kg IV bolus followed by doses of 0.125, or 0.25 mg/kg/hr given on days 1 through 7 with standard induction therapy, on days 1 through 5 or 7 with standard re-induction therapy, and on days 1, 3 and 5 with standard consolidation therapy
16413693|NCT02873338|Drug|Cytarabine|"100 mg/m2/day by continuous IV infusion on days 1 through 7 of induction therapy, and on days 1 through 5 of re-induction therapy
~1.0 g/m2 IV infusion given over 3 hours every 12 hours on days 1, 3, and 5 of consolidation therapy"
16413694|NCT02864290|Drug|ASP1235|intravenous (IV) infusion
16413695|NCT02861586|Biological|MV-CHIK low dose|recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
16413696|NCT02861586|Biological|MV-CHIK high dose|recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
16413697|NCT02861586|Biological|Priorix®|lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
16413698|NCT02861586|Biological|physiological saline solution|sterile physiological saline solution 0.9% used as placebo
16413699|NCT02853344|Biological|Pembrolizumab|IV infusion
16413700|NCT02848001|Drug|CC-90009|CC-90009
16413701|NCT02838836|Procedure|Study sample collection|Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
16413702|NCT02835157|Drug|Balanced crystalloid solution|Multiple electrolyte solution as boluses would be administered.
16413703|NCT02835157|Drug|0.9%sodium chloride|saline as boluses would be administered
16413704|NCT02834013|Procedure|Biospecimen Collection|Undergo optional collection of biopsy tissue and blood
16413705|NCT02834013|Biological|Ipilimumab|Given IV
16413706|NCT02834013|Biological|Nivolumab|Given IV
16413707|NCT02831049|Behavioral|Retrieval-extinction|Retrieval-extinction
16413708|NCT02831049|Behavioral|Extinction|extinction
16413709|NCT02831049|Behavioral|Retrieval|Retrieval
16413710|NCT02825420|Drug|trabectedin|
16413711|NCT02821832|Procedure|Saliva collection|For biomarker assessments
16413712|NCT02821832|Procedure|Urine collection|For biomarker assessments
16413713|NCT02821832|Procedure|Sputum collection|For primary endpoint assessments and other biomarker assessments
16413714|NCT02821832|Procedure|Blood Collection|For biomarker and eligibility assessments
16413715|NCT02821832|Radiation|PET/CT Scan|Imaging of the lungs to establish disease extent and severity
16413716|NCT02821832|Drug|Isoniazid, Rifampicin, Pyrazinamide and Ethambutol|Treatment-standard of care
16413717|NCT02813655|Drug|Tetracosactide (Synacthène®)|"Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®.
~All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15."
16413718|NCT02813655|Drug|placebo saline (0.9% NaCl)|"placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline.
~All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15."
16413719|NCT02773732|Drug|Ciprofloxacin|"Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
~Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg"
16413720|NCT02773732|Drug|Etoposide|Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
16413721|NCT02770820|Biological|Aldesleukin|Given SC
16413722|NCT02770820|Biological|Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes|Given IV
16413723|NCT02770820|Other|Laboratory Biomarker Analysis|Correlative studies
16413724|NCT02747407|Biological|Hepatitis A Vaccine|
16413725|NCT02747407|Other|Laboratory Biomarker Analysis|Correlative studies
16413726|NCT02747407|Biological|Tetanus Toxoid Vaccine|
16413727|NCT02747407|Biological|Trivalent Influenza Vaccine|
16413728|NCT02740699|Drug|Rosuvastatin|Participants will receive 20-40 mg once daily
16413729|NCT02740699|Drug|Atorvastatin|Participants will receive 40-80 mg once daily.
16413730|NCT02718833|Drug|Elotuzumab|
16413731|NCT02718833|Drug|Pomalidomide|
16413732|NCT02718833|Drug|Bortezomib|
16413733|NCT02718833|Drug|Dexamethasone|
16413734|NCT02718001|Device|Edwards EVOQUE Eos Mitral Valve Replacement System|Replacement of the mitral valve through a transcatheter approach
16413735|NCT02709226|Radiation|Radiation|Radiation therapy will be administered daily Monday-Friday at NCI, ROB unless the treatment schedule requires amendment in the event of inclement weather or federal holidays. Radiation therapy dose will be administered as per on consecutive treatment days, 5 fractions per week via a linear accelerator using 6 MV photons or greater. Dose escalation is as follows: dose level 1 (DL1) 3.5 Gy x 10; dose level 2 (DL2) 3.5 Gy x 12; dose level 3 (DL3) 3.5 Gy x 14. If 2 DLTs are observed in the second dose level a step down dose of 3.0 Gy x 14 fractions will be tested. If 2 DLTs are observed in the third dose level a step down dose of 3.0 Gy x 17 fractions will be tested. The study will have 3 planned re-irradiation dose levels, with 1 to 6 patients per dose level using the 3+3 design to define the MTD. The number of patients may be increased to 9 total patients at the MTD ( provided no DLT) with a maximum of 21 evaluable patients enrolled.
16413736|NCT02701283|Device|Medtronic Transcatheter Aortic Valve Replacement Systems|Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
16413737|NCT02701283|Device|Surgical Aortic Valve Replacement (SAVR)|Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis
16413738|NCT02700841|Drug|Melphalan|Given IV
16413739|NCT02700841|Procedure|Peripheral Blood Stem Cell Transplantation--CD34 HSCT|Undergo autologous CD34 HSCT
16413740|NCT02700841|Procedure|Peripheral Blood Stem Cell Transplantation--AHSCT|Undergo AHSCT
16413741|NCT02700841|Biological|T Cell-Depleted Hematopoietic Stem Cell Transplantation|Undergo autologous CD34 HSCT
16413742|NCT02700841|Biological|Tetanus Toxoid Vaccine|Given IM
16413743|NCT02696382|Behavioral|Progressive High Intensity Therapy (PHIT)|"Participants in the Progressive High Intensity Therapy (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program."
16413744|NCT02696382|Behavioral|Usual Care (UC)|"Participants in the Usual Care group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program."
16413745|NCT02688621|Behavioral|Internet Only|18 month behavioral weight loss intervention delivered online
16413746|NCT02688621|Behavioral|Internet + Incentives|18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing
16413747|NCT02687360|Device|Active rTMS treatment|In the active treatment, magnetic power output will be delivered to the participants through the coils.
16413748|NCT02687360|Device|Sham rTMS treatment|The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
16413749|NCT02683941|Drug|Lanreotide (Autogel formulation)|120mg every 28 days until disease progression, death, or unacceptable toxicity
16413750|NCT02683941|Drug|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days until disease progression.
16413751|NCT02683941|Drug|Best Supportive Care|Best Supportive Care is best available therapy at the choice of the investigator
16413752|NCT02674464|Behavioral|Provider Audit-Feedback, Stratified by Race and Ethnicity|Transparent and timely access to and review of clinical performance data are among the key elements of successful improvement activities. The RICH LIFE Project provides the health systems with the logic to build practice and provider level hypertension (HTN) dashboards, support in building the dashboard, and education in utilizing the dashboard. The practice dashboard provides a display of the percentage of patients achieving BP control, defined as <140/90 mm Hg for the overall practice, while the provider dashboard provides a display of the percentage of patients achieving BP control for each provider's patient panel. Both the practice and provider Dashboards stratify hypertension performance data by race (White, non-Hispanic; Black, non-Hispanic; and All Hispanic) to help practice administration and clinicians evaluate differences between races and ethnicities in BP control rates. New reports are generated at least quarterly and will display data from the previous 3 months.
16413753|NCT02674464|Behavioral|Blood Pressure Measurement Standardization|"All adult medicine staff at participating study practices receive standardized, evidence-based, best practices BP measurement training. Aspects of the training include proper patient preparation and positioning, how use of an automated BP measurement device, and executing a screen and confirm protocol when measuring patients' blood pressures."
16413754|NCT02674464|Behavioral|System Level Leadership Intervention|"This System-Level Leadership intervention aims to create a learning network through an inter-organizational approach to promote health equity and reduce CVD disparities. Elements of the system-level leadership intervention, then, include: 1) an introductory session during the kick-off event (baseline); 2) a quarterly 1 hour content call with a presentation on leading for equity and discussion among system-level leaders, community organization leaders, and interested practice champions in the CC/Stepped care arm conducted via conference call/webinar; and 3) monthly coaching calls for the system and practice level leaders, CMs, and CHWs in the CC/stepped care arm to discuss the interventions, while they are actively engaged in the intervention phase."
16413755|NCT02674464|Behavioral|Collaborative Care Team Intervention|The collaborative care intervention creates a collaborative care team that, at a minimum, consists of PCP, nurse, or social worker care manager, and community health worker. The collaborative care team develops the medical management plan in partnership with patients; 2) uses care coordination to maximize interaction of the patients' PCPs with other care providers addressing medication management, patient self-management, and psychosocial support on a regular, consistent basis; and 3) determines patient access to CHW support and subspecialty consultations.
16413756|NCT02674464|Behavioral|Community Health Worker Referral|"As a stepped up component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants"
16413757|NCT02674464|Behavioral|Specialist Care Consultation|"As a stepped up component of the Collaborative Care Team Intervention for patients with complex medical conditions and/or patients that may not typically have access to specialist care"
16413758|NCT02670408|Procedure|Endomyocardial biopsy|One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.
16413759|NCT02669251|Drug|MPH966|"Phase 1b Cycle= 14 days: Each dose level will increase by 60mg PO BID, up to a maximum of 240mg PO BID
~Phase 2 Cycle=28 days: MTD PO BID"
16413760|NCT02669225|Other|[18F]florbetaben|PET radiotracer to image Amyloid beta (AB) load in human brain.
16413761|NCT02653664|Behavioral|PsychoEducation|Condition #1
16413762|NCT02653664|Behavioral|Self-Hypnosis Training|Condition #2
16413763|NCT02653664|Behavioral|Mindfulness Meditation|Condition #3
16413764|NCT02639273|Drug|Nalmefene|Active Drug
16413765|NCT02639273|Other|Placebo|Single Dose Placebo
16413766|NCT02586857|Drug|ACP-196|Cohort 1: ACP-196 200 mg (PO) twice per day (BID) Cohort 2: ACP-196 400 mg (PO) once per day (QD).
16413767|NCT02579850|Drug|CHF 5993 + Ultibro matched placebo|Active medication treatment CHF 5993 and Ultibro matched placebo administered twice a day
16413768|NCT02579850|Drug|Ultibro + CHF 5993 matched placebo|Active medication treatment Ultibro and CHF 5993 matched placebo administered twice a day
16413769|NCT02579850|Procedure|Central spirometry|Central spirometry to assess forced expiratory volume at one second and forced vital capacity
16413770|NCT02579850|Other|COPD assessment test|COPD assessment test (CAT) at visit 1
16413771|NCT02579850|Procedure|Local laboratory Assessments|ECG + Standard Haematology and Biochemistry
16413772|NCT02579850|Other|Saint George's Respiratory Questionnaire|Saint George's Respiratory Questionnaire
16413773|NCT02579850|Other|EXACT-pro questionnaire|daily from randomization (Visit 2) to end of study (Visit 7)
16413774|NCT02557438|Procedure|Roux-en-Y Gastric Bypass|Determination of the kind of surgery will be made by the participant's providers and not by study staff
16413775|NCT02557438|Procedure|Vertical Sleeve Gastrectomy|Determination of the kind of surgery will be made by the participant's providers and not by study staff
16413776|NCT02552225|Drug|Amitriptyline|Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
16413777|NCT02552225|Other|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
16413778|NCT02550522|Device|Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton|
16413779|NCT02522611|Drug|Resiniferatoxin|Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone.
16413780|NCT02515916|Other|Not Interventional|This will be a prospective, non-randomized, uncontrolled study examining the effects of oncology treatments in women at risk for treatment induced ovarian failure.
16413781|NCT02498964|Other|Teaching,education,feedback and practice sessions to help improve as needed|Group discussion,individual attention and teaching as needed,more teaching using different modalities like powerpoint and hands on experience
16413782|NCT02467452|Drug|BDP/FF/GB|
16413783|NCT02467452|Drug|FlF/VI + Tiotropium|
16413784|NCT02466971|Radiation|Brachytherapy|Undergo brachytherapy
16413785|NCT02466971|Drug|Cisplatin|Given IV
16413786|NCT02466971|Radiation|External Beam Radiation Therapy|Undergo EBRT
16413787|NCT02466971|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16413788|NCT02466971|Other|Laboratory Biomarker Analysis|Correlative studies
16413789|NCT02466971|Radiation|Radiation Therapy|Undergo conventional RT
16413790|NCT02466971|Drug|Triapine|Given IV
16413791|NCT02451943|Drug|Olaratumab|Administered IV
16413792|NCT02451943|Drug|Doxorubicin|Administered IV
16413793|NCT02451943|Drug|Placebo|Administered IV
16413794|NCT02446626|Procedure|Skin biopsy|Optional 2-3mm skin punch biopsies will be performed.
16413795|NCT02446626|Procedure|Blood draw|Peripheral blood draws will be performed.
16413796|NCT02446626|Device|Xenodiagnosis|Larval ticks will be obtained from Dr. Sam Telford from a laboratory maintained tick colony at Tufts Veterinary School. These ticks are hatchedfrom eggs laid by ticks that have fed only on specific pathogen free laboratory animals that were purchased from established vendors. Between 25-30 larval ticks that have been aged and are known to be ready to attach will be placed on the study participant.
16413797|NCT02443077|Procedure|Autologous Bone Marrow Transplantation|Undergo autologous hematopoietic progenitor cells or bone marrow transplant
16413798|NCT02443077|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous hematopoietic progenitor cells or bone marrow transplant
16413799|NCT02443077|Drug|Carmustine|Given IV
16413800|NCT02443077|Drug|Cyclophosphamide|Given IV
16413801|NCT02443077|Drug|Cytarabine|Given IV
16413802|NCT02443077|Drug|Etoposide|Given IV
16413803|NCT02443077|Drug|Ibrutinib|Given PO
16413804|NCT02443077|Other|Laboratory Biomarker Analysis|Correlative studies
16413805|NCT02443077|Drug|Melphalan|Given IV
16413806|NCT02443077|Other|Pharmacogenomic Study|Correlative studies
16413807|NCT02443077|Other|Placebo Administration|Given PO
16413808|NCT02381522|Other|Remote Ischemic Pre-conditioning|
16413809|NCT02381522|Other|Sham RIPC|
16413810|NCT02371681|Drug|Treatment|Different Drug combinations
16413811|NCT02371681|Radiation|PET/CT Scan|PET/CT Scans
16413812|NCT02371681|Procedure|Sample Collection|Sample Collection
16413813|NCT02369575|Other|novel biomarkers of lung disease|we will be identifying molecular, genetic, and cellular markers of lung disease
16413814|NCT02369458|Drug|Mitomycin-C|
16413815|NCT02369458|Drug|Pegfilgrastim|
16413816|NCT02359864|Radiation|5 daily fractions of 2 Gy|Whole Brain Irradiation to treat Alzheimer's Disease
16413817|NCT02359864|Radiation|10 daily fractions of 2 Gy|Whole Brain Irradiation to treat Alzheimer's Disease
16413818|NCT02359825|Drug|Polyethylene glycol (PEG)|For the control groups, epineural repair or interposition grafting will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon. For the experimental group, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon.
16413819|NCT02356939|Device|intraductal removable stent custom-made segment (2 cm)|": In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube. The stent is inserted in the biliary duct without suture fixation.
~In order to minimize bias and to homogenize the technique, a short technical explanatory movie was realized by the promoter's team and edited on internet.
~In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1."
16413820|NCT02356939|Procedure|stent extraction by ERCP|stent extraction by endoscopic retrograde cholangio-pancreatography
16413965|NCT01407198|Radiation|Radiation therapy|External beam radiation will be delivered at 1.8 Gy per day, 5 days per week (excluding holidays)for a total of 28 fractions over a 6 weeks period.
16413821|NCT02311374|Other|Brain connectivity and physiology|Two MRI scanning session will be obtained for each participant both at the same time of day (9AM 12 PM). In one occasion they will be scanned after a night of rested sleep while awake and on another day they will be scanned after one night of sleep deprivation while sleeping in the scanner. In addition to the most sensitive technique selected in the development phase (either DWI or MT), each imaging MRI session will include (1) a resting- state functional connectivity (RSFC; 10 minutes) scan using single-shot T2*-weighted EPI; and (2) quantitative T1 relaxometry (T1) in a CSF voxel (1mL; cubic) using an inversion recovery experiment with increased interpulse intervals (TI = 200, 300, 400, 500, 700, 1000, 1500, 2000, 3000, 5000, 10000 ms) and a long TR (10000 ms; scan time 2 min) to assess the level of solutes in CSF.
16413822|NCT02311374|Other|Brain Wave|ECG will be used to monitor heart rate variability (HRV), which differ significantly between the waking state and the different sleep stages
16413823|NCT02287272|Drug|CHF 5993 pMDI|4 inhalations of CHF 5993 pMDI (BDP/FF/GB 100/6/25 micrograms per actuation) giving a total dose of 400, 24, 100 micrograms of BDP, FF, GB
16413824|NCT02287272|Drug|Cimetidine plus CHF5993 pMDI|Cimetidine 800 milligrams twice daily for 6 days. On the fourth day, in addition, 4 inhalations of CHF5993 pMDI (BDP/FF/GB total dose 400/24/100 micrograms)
16413825|NCT02273726|Drug|Epoetin Alfa|Epoetin alfa will be administered per dose and schedule specified in the arm.
16413826|NCT02273726|Drug|Roxadustat|Roxadustat will be administered per dose and schedule specified in the arm.
16413827|NCT02233868|Other|connectivity|Magnetic resonance imaging (MRI) scans will be done to assess brain structure, functional reactivity and functional connectivity.
16413828|NCT02233868|Other|neuroinflammation|The use of [11C]PBR28 will allow us to assess for the first time in vivo if there is neuroinflammation in the brain of alcoholics. It will also allow us to assess if it recovers with alcohol detoxification.
16413829|NCT02233868|Drug|neurofunction|To assess regional brain glucose metabolism.
16413830|NCT02211768|Procedure|MRI, FDG-PET/CT scans|Standard of care to be obtained as part of the study
16413831|NCT02211768|Drug|[18F]-FLT-PET/CT scans|FLT PET to be performed as a research imaging study as it is not considered standard imaging in NF1
16413832|NCT02203526|Drug|Isavuconazole|Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy (cycles 1-6)
16413833|NCT02203526|Drug|TEDDI|Temozolomide, etoposide, doxil, dexamthasone, ibrutinib (TEDDI) given every 21 days for cycles 2-6 (Arm 1-A); given every 21 days for cycles 1-6 (Arms 1-B, 2 and 3)
16413834|NCT02203526|Biological|Rituximab|Rituximab (R) given with TEDD and TEDDI every 3 weeks for cycles 1-6 (all arms)
16413835|NCT02203526|Drug|Cytarabine|Cytarabine given via Ommaya reservoir (IT therapy) on days 1 and day 5 of cycles 2-6 (all arms)
16413836|NCT02203526|Drug|TEDD|Temozolomide, etoposide, doxil, dexamthasone, (TEDD) given on first cycle (Arm 1-A)
16413837|NCT02203526|Drug|Ibrutinib (Arms 2 and 3)|Ibrutinib given on day -3 to day -1 on cycle 1 (Arms 2, 3 and 4)
16413838|NCT02203526|Drug|Ibrutinib (Arm 1 - Closed with Amendment G)|Ibrutinib given on day -14 to day -1 on cycle 1 (Arm 1)
16413839|NCT02203526|Drug|Ibrutinib (Arm 4)|Ibrutinib given on days 1-10 for cycles 1-6 (Arm 4)
16413840|NCT02201108|Drug|Teriflunomide|Pharmaceutical form:film-coated tablet, Route of administration: oral
16413841|NCT02201108|Drug|Placebo|Pharmaceutical form:tablet, Route of administration: oral
16413842|NCT02194738|Drug|Carboplatin|Given IV
16413843|NCT02194738|Drug|Cisplatin|Given IV
16413844|NCT02194738|Other|Clinical Observation|Undergo observation
16413845|NCT02194738|Drug|Crizotinib|Given PO
16413846|NCT02194738|Other|Cytology Specimen Collection Procedure|Undergo collection of blood and tissue
16413847|NCT02194738|Drug|Erlotinib|Given PO
16413848|NCT02194738|Drug|Gemcitabine Hydrochloride|Given IV
16413849|NCT02194738|Biological|Nivolumab|Given IV
16413850|NCT02194738|Drug|Paclitaxel|Given IV
16413851|NCT02194738|Biological|Pembrolizumab|Given IV
16413852|NCT02194738|Drug|Pemetrexed|Given IV
16413853|NCT02194738|Drug|Pemetrexed Disodium|Given IV
16413854|NCT02194738|Other|Placebo Administration|Given PO
16413855|NCT02189577|Drug|CHF 5259|Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
16413856|NCT02189577|Drug|Placebo|Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
16413857|NCT02168140|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16413858|NCT02168140|Drug|bendamustine hydrochloride|Given IV
16413859|NCT02160730|Drug|R-roscovitine|See Arm Description
16413860|NCT02153957|Behavioral|Physical Activity|12 weeks of enhanced physical activity with Zamzee monitor.
16413861|NCT02143050|Drug|Dabrafenib|
16413862|NCT02143050|Drug|Trametinib|
16413863|NCT02143050|Drug|Metformin|
16413864|NCT02125786|Radiation|Irradiation|Radiation therapy on this protocol will be based on extent of disease, extent of resection and location. The allowed treatment modalities include conformal or intensity-modulated radiation therapy using photons or proton therapy using double-scattering or spot-scanning methods. The general goal is to initiate radiation therapy within 12 weeks of last surgery performed at the time of recurrence.
16413865|NCT02125786|Procedure|Surgery|When applicable, surgery will be used to remove metastases. The goal of surgery is to achieve gross total resection of all imaging visible residual tumor.
16413866|NCT02125786|Drug|^1^8F-Fluorodeoxyglucose|This is a contrast media that will be given intravenously to aid in tumor visualization.
16413867|NCT02125786|Drug|^1^1C-methionine|This is a contrast media that will be given intravenously to aid in tumor visualization.
16413868|NCT02125786|Device|Photon therapy|Participants will receive one or both: Photon or proton therapy.
16413869|NCT02125786|Device|Proton therapy|Participants will receive one or both: Photon or proton therapy.
16413870|NCT02119234|Drug|Beclometasone/formoterol/glycopyrrolate|
16413871|NCT02119234|Drug|Placebo|
16414007|NCT01176747|Drug|BDP/formoterol NEXT DPI|Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
16413872|NCT02107989|Device|MRI|MRI of the brain is routinely used to identify abnormal areas of cortex in patients with medically refractory epilepsy. MRI evaluations of brain may be performed at field strengths of 1.5 T, 3T, and/or 7T, under conditions designated by the FDA as constituting nonsignificant risk.
16413873|NCT02107989|Device|MEG|"MEG/EEG:
~Magnetoencephalogra phy (MEG) is commonly used during epilepsy pre- surgical evaluations to help with localizing epileptic foci. MEG will be obtained as clinically indicated, usually in patients with unclear seizure focus localization who are undergoing presurgical evaluation, particularly when they have frequent interictal discharges on EEG. MEG records very small magnetic fields generated by the brain at rest, or in response to a task or to epileptic activity. Resting state MEG/EEG analysis will be used for research purposes only."
16413874|NCT02088554|Device|Model 400 aortic valve bioprosthesis|
16413875|NCT02040597|Drug|Beclometasone/Formoterol/Glycopyrrolate|
16413876|NCT02035566|Other|Telehome Care Monitoring|Telehome care monitoring over a 60-day period wherein patients transmit health measurements to their health care professional on a daily basis
16413877|NCT02020707|Biological|Bevacizumab|Given IV
16413878|NCT02020707|Other|Laboratory Biomarker Analysis|Correlative studies
16413879|NCT02020707|Drug|Nab-paclitaxel|Given IV
16413880|NCT02020707|Other|Pharmacological Study|Correlative studies
16413881|NCT02018549|Device|Inhalation through Chiesi NEXThaler DPI|Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
16413882|NCT02015013|Biological|Filgrastim|10 g/kg daily for 5 days, Subcutaneous injection
16413883|NCT02015013|Drug|Plerixafor|IV injection 0.24 mg/kg as a single dose, 11 hours prior to apheresis
16413884|NCT02000609|Drug|CHF 1535 NEXThaler 800/48|
16413885|NCT02000609|Drug|CHF 1535 NEXThaler 200/12|
16413886|NCT02000609|Drug|CHF 1535 NEXThaler PLACEBO|
16413887|NCT02000609|Drug|CHF 1535 pMDI 200/12|
16413888|NCT02000609|Drug|CHF1535 pMDI 800/48|
16413889|NCT01993719|Drug|Aldesleukin|720,000 IU/kg IV every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).
16413890|NCT01993719|Drug|Fludarabine|25 mg/m2/day IVPB daily for 5 days
16413891|NCT01993719|Drug|Cyclophosphamide|60 mg/kg/day X 2 days IV or 30 mg/kg/day X 2 days IV. Days -5 to -3 (low-dose arm-CLOSED): Cyclophosphamide 300 mg/m2 IV over 60 minutes.
16413892|NCT01993719|Biological|Young TIL|Day 0: Cells will be infused intravenously (IV)
16413893|NCT01993719|Drug|Pembrolizumab (Keytruda)|2 mg/kg IV on Days -2, 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days).
16413894|NCT01989585|Drug|Dabrafenib|Given PO
16413895|NCT01989585|Other|Laboratory Biomarker Analysis|Correlative studies
16413896|NCT01989585|Biological|Navitoclax|Given PO
16413897|NCT01989585|Other|Pharmacological Study|Correlative studies
16413898|NCT01989585|Drug|Trametinib|Given PO
16413899|NCT01917331|Drug|Beclometasone/Formoterol/Glycopyrrolate|Active drug tested
16413900|NCT01917331|Drug|Beclometasone/Formoterol|Active comparator
16413901|NCT01915212|Biological|HSV529|The vaccine was administered intramuscularly (deltoid muscle) as a 0.5 ml solution containing 1 x 10(7) plaque forming units on day 0, one month after the first dose (day 30) and then six months after the first dose (day 180).
16413902|NCT01915212|Other|Placebo|Sodium Chloride 0.9%
16413903|NCT01912807|Drug|Dextrose (D5NS)|Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight
16413904|NCT01912807|Drug|Ondansetron (Control)|Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
16413905|NCT01911364|Drug|BDP/FF/GB|Superiority over Tiotropium
16413906|NCT01911364|Drug|Tiotropium|Superiority of CHF5993 over Tiotropium
16413907|NCT01911364|Drug|BDP/FF + Tiotropium|non inferiority vs CHF5993
16413908|NCT01877655|Biological|ASP0113|Intramuscular injection
16413909|NCT01877655|Drug|Placebo|Intramuscular injection
16413910|NCT01861093|Biological|Cord Blood Units|cord blood units for transplants
16413911|NCT01858168|Drug|Olaparib|Tablets to be taken on an empty stomach twice a day.
16413912|NCT01858168|Drug|Temozolomide|Tablets to be taken on an empty stomach before bedtime.
16413913|NCT01858168|Drug|Irinotecan|Administered via IV
16413914|NCT01798407|Device|Activa Tremor Control Sys (DBS Implant)|DBS system consists of the Activa RC 37612 System (Implantable Pulse Generator with Model 37085 Extensions (40 to 95cm), Activa Patient Programmer, and Medtronic Model 3389 DBS Lead). This system is commercially approved for the treatment of chronic, intractable Parkinson's Disease. It will be used with the Model SP-10344 Memory Mod Software which enables the physician to program the Implantable Pulse Generator to a higher frequency.
16413915|NCT01798407|Other|Randomized, staggered withdrawal phase|For responders only: double blind discontinuation will be attempted on either the 12 or 13 month visit. Stimulation intensity will be decreased by 50% and then completely discontinued two weeks later. Subjects will be seen biweekly until 15 months post activation or escape criteria are met. These escape criteria include relapse at 2 visits, hospitalization, active suicidal ideation, or withdrawing consent. If any of these criteria are met, the blind will be broken and open treatment will be resumed.
16413916|NCT01766297|Radiation|Proton Radiotherapy|
16413917|NCT01758445|Radiation|Proton Radiotherapy|Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol & physician.
16413918|NCT01750918|Drug|Dabrafenib|Each capsule contains 50 mg or 75 mg of GSK2118436; 50 mg strength capsules are Swedish orange (dark red) opaque hypromellose size 2 capsules and 75 mg strength capsules are pink opaque hypromellose size 1 capsules. The initial dosing regimen will be twice daily (BID) continuous oral daily dosing.
16413919|NCT01750918|Drug|Trametinib|Each tablet contains 0.5mg or 2.0 mg GSK1120212; 0.5 mg is yellow modified oval biconvex film-coated tablets of size 4.8 mm X 8.9 mm and 2 mg as pink round biconvex film coated tablets;7.5 mm in diameter. The initial dosing regimen will be once daily continuous oral daily dosing.
16414184|NCT00000912|Drug|Adefovir dipivoxil|
16414185|NCT00000912|Drug|Saquinavir|
16414186|NCT00000909|Drug|Aldesleukin|
16414187|NCT00000902|Drug|Ritonavir|
16413920|NCT01750918|Drug|Panitumumab|Panitumumab is a sterile, colorless, translucent-to-white amorphous, proteinaceous powder available as 100 mg panitumumab in 5 mL (20 mg/mL) single-use vial; 200 mg panitumumab in 10 mL (20 mg/mL) single-use vial; 400 mg panitumumab in 20 mL (20 mg/mL) single-use vial; to be administered as an intravenous infusion over 60 minutes, every 14 days. Doses higher than 1000 mg should be administered over 90 minutes.
16413921|NCT01750918|Device|5-fluorouracil|5-fluorouracil-based chemotherapy
16413922|NCT01746238|Drug|Bevacizumab|Intravenous infusion, every 2 weeks, 3 doses total
16413923|NCT01746238|Drug|Doxorubicin|Intravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks
16413924|NCT01746238|Radiation|Radiation Therapy|Daily, Monday-Friday, for 6 weeks
16413925|NCT01738087|Drug|NEXThaler 100/6 mcg DPI|
16413926|NCT01738087|Drug|Flixotide Accuhaler 500 mcg|Active comparator
16413927|NCT01738087|Drug|NEXThaler 200/6 mcg DPI|
16413928|NCT01738087|Drug|NEXThaler placebo|Placebo comparator
16413929|NCT01638676|Drug|Vemurafenib|Vemurafenib (960 mg PO daily) in patients with unresectable BRAFV600E positive Stage IIIC and Stage IV melanoma
16413930|NCT01638676|Drug|Metformin|Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)
16413931|NCT01610843|Other|Survey|Longitudinal surveys
16413932|NCT01603225|Procedure|Transcranial Direct Current Stimulation (tDCS)|Delivery of transcranial direct current stimulation for 30-60 minutes or sham stimulation.This will be administered by two or more similar devices.
16413933|NCT01585103|Device|Cytosponge - Brushing|"Patients with eosinophilic esophagitis will be enrolled. Undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease.
~Two hours prior to endoscopy in the patients will be asked to swallow the Cytosponge. Briefly, the capsule and bunched up string are swallowed with water.
~The string is held without any tension to allow the capsule to move into the stomach. The patient holds onto the string for five minutes after ingestion to allow the capsule to dissolve in the proximal stomach, where a spherical mesh of 3 cm diameter is released.
~The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position.
~Following this, the clinically indicated endoscopy will be performed. Prior to biopsies we will do a brushing of the esophagus."
16413934|NCT01584505|Drug|CHF1535 + CHF5992 dose 1 BID|CHF1535 + CHF5992 dose 1 BID for 14 days
16413935|NCT01584505|Drug|CHF1535 + CHF5992 dose2 BID|CHF1535 + CHF5992 dose 2 BID for 14 days
16413936|NCT01584505|Drug|CHF1535 daily dose|CHF1535 daily dose for 14 days
16413937|NCT01577082|Drug|CHF1535 200/6 µg|CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks
16413938|NCT01577082|Drug|BDP 100 µg|Beclomethasone Dipropionate 800µg daily during 12 weeks
16413939|NCT01572506|Drug|Biotin RBC survival|
16413940|NCT01562405|Drug|ACE-011|Injection every 28 days, dose escalation levels from 15-45 mg
16413941|NCT01562405|Drug|Lenalidomide|15 to 25 mg days 1-21, given orally
16413942|NCT01562405|Drug|Dexamethasone|40 mg days 1,8,15,22; given orally
16413943|NCT01562405|Drug|Pomalidomide|Pomalidomide 4 mg daily on days 1-21
16413944|NCT01550003|Drug|Certolizumab Pegol (CZP)|"CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study.
~CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution.
~Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range.
~Reduced CZP regimen (after implementation of protocol amendments 4 and 5):
~10 to < 20 kg: Loading dose = 50 mg Q2W (1 x 0.25 mL sc); treatment dose = 50 mg Q4W (1 x 0.25 mL sc);
~20 to < 40 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc,); treatment dose = 50 mg Q2W (1 x 0.25 mL sc);
~≥ 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);"
16413945|NCT01550003|Drug|Certolizumab Pegol (CZP)|"CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study.
~CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution.
~Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range.
~Original CZP regimen (prior to implementation of protocol amendments 4 and 5 and after implementation of protocol amendment 9):
~10 to < 20 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc); treatment dose = 50 mg Q2W (1 x 0.25 mL sc);
~20 to < 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc,); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);
~≥ 40 kg: Loading dose = 400 mg Q2W (2 x 1.0 mL sc); treatment dose = 200 mg Q2W (1 x 1.0 mL sc);"
16413946|NCT01534481|Biological|Donor Milk|Donor milk provided by the Human Milk Banking Association of North America
16413947|NCT01534481|Dietary Supplement|Preterm Formula|Preterm Formula determined by center practice.
16413948|NCT01489189|Other|Prompt Panretinal Photocoagulation|Panretinal photocoagulation alone at baseline (full session completed within 56 days).
16413949|NCT01489189|Drug|0.5-mg Ranibizumab|Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
16413950|NCT01489189|Other|Deferred panretinal photocoagulation|PRP is deferred until failure/futility criteria for intravitreal injection are met.
16413951|NCT01476813|Drug|Glycopyrrolate|comparison of different dosages of drug
16413952|NCT01476813|Drug|Glycopyrrolate|comparison of different dosages of drug
16413953|NCT01476813|Drug|Glycopyrrolate|comparison of different dosages of drug
16413954|NCT01476813|Drug|Comparator|comparison of different dosages of drug versus comparator
16413955|NCT01412879|Biological|rituximab|Given IV
16413956|NCT01412879|Drug|bendamustine hydrochloride|Given IV
16413957|NCT01412879|Drug|cyclophosphamide|Given IV
16413958|NCT01412879|Drug|cytarabine|Given IV
16413959|NCT01412879|Drug|dexamethasone|Given PO or IV
16413960|NCT01412879|Drug|doxorubicin hydrochloride|Given IV
16413961|NCT01412879|Drug|leucovorin calcium|Given PO or IV
16413962|NCT01412879|Drug|methotrexate|Given IV
16413963|NCT01412879|Drug|vincristine sulfate|Given IV
16413964|NCT01407198|Drug|Nilotinib|Orally, daily 200 - 400 mg BID
16413966|NCT01402492|Drug|Buprenorphine + Naltrexone|Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
16413967|NCT01402492|Drug|Placebo + Naltrexone|Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
16413968|NCT01398111|Drug|Glycopyrrolate + Formoterol|glycopyrrolate pMDI + formoterol pMDI
16413969|NCT01398111|Drug|Glycopyrrolate|glycopyrrolate pMDI
16413970|NCT01398111|Drug|Formoterol|formoterol pMDI
16413971|NCT01398111|Drug|Placebo|placebo pMDI
16413972|NCT01379222|Device|Endurant Stent Graft System|The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
16413973|NCT01362803|Drug|AZD6244|AZD6244 orally (at recommended Ph2 dose) every 12 hours on continuous daily schedule for cycles of 28 days until unacceptable toxicity, patient withdrawal or PD
16413974|NCT01352962|Drug|Gemcitabine|1,000mg/m2 IVPB over 30 min x 1
16413975|NCT01352962|Drug|Carboplatin|AUC 5** IVPB over 30 min x 1
16413976|NCT01352962|Drug|Lenalidomide|Escalating Doses starting at 2.5 po daily up to 25 mg po daily until MTD is reached.
16413977|NCT01343745|Drug|BDP/formoterol|pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
16413978|NCT01343745|Drug|BDP/formoterol|pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
16413979|NCT01343745|Drug|Placebo|pressurised metered dose inhaler
16413980|NCT01326715|Drug|Mangafodipir (Teslascan)|gadolinium enhancement on contrast enhanced brain MRI.
16413981|NCT01319565|Drug|Aldesleukin|Arm 1 and Arm 2 - Days 1 to 4: Aldeskeukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
16413982|NCT01319565|Drug|Cyclophosphamide|Arm 1 and Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 mL D5W with Mesna 15 mg/kg /day X 2 days over 1 hr.
16413983|NCT01319565|Drug|Fludarabine|Arm 1 and Arm 2 - Days -7 to -3: Fludarabine 25 mg /m2/day IVPB daily over 15-30 minutes for 5 days.
16413984|NCT01319565|Biological|Young Tumor Infiltrating Lymphocytes|Arm 1 and Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
16413985|NCT01319565|Radiation|Total Body Irradiation (TBI)|Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg IV x 1 dose pre-TBI. Patients will then receive 2 Gy TBI twice a day for 3 days (total dose 12 Gy) using a linear accelerator in Radiation Oncology.
16413986|NCT01306019|Drug|Palifermin|Mucositis prophylaxis commenced- Infusion of keratinocyte growth factor (palifermin) at 60 mcg/kg/day before (Days -6 to Day -4) administration of busulfan
16413987|NCT01306019|Drug|Busulfan|3mg/kg per day with drug levels obtained on Day -3. Busulfan dose on day -2 will be adjusted (if busulfan AUC result is available) to achieve targeted busulfan AUC 4500 min*umol/L/day. If result is not available in time to make an adjustment, then proceed to give the standard 3mg/kg on the second day
16413988|NCT01306019|Biological|Ex vivo culture and transduction of the patient's autologous CD34+ HSC with lentivirus vector VSV-G pseudotyped CL20- 4i-EF1a-hyc-OPT vector|Transduced cell product administered intravenously over <30 minutes by a PI or designated Associate Investigator at the NIH Clinical Center.
16413989|NCT01266577|Other|NSR MAGNETOM 7T|The 7 Tesla scanner is a magnet system used to acquire magnetic resonance imaging and spectroscopy
16413990|NCT01266577|Other|1Tx x 32Rx Head Coil|Used to perform proton imaging and spectroscopy in the human heads.
16413991|NCT01246752|Biological|Human Stem Cell Transplantation|Human allogenic stem cells
16413992|NCT01246752|Drug|Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)|Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
16413993|NCT01236521|Drug|Pharmacological (MED)|"During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling.
~The Patients in the MED arm will be asked to sign an opioid treatment agreement at enrollment."
16413994|NCT01236521|Behavioral|Behavioral treatment (CBT)|There will be 8 sessions of pain self-management and coping skills.
16413995|NCT01230866|Radiation|Proton Radiation Hypofractionation|Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
16413996|NCT01230866|Radiation|Proton Radiation Standard Fractionation|Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
16413997|NCT01222767|Drug|Zalypsis|Zalypsis is provided as a lyophilized powder for concentrate for solution for infusion in a strength of 2.5 mg/vial.
16413998|NCT01212029|Behavioral|Behavioral measures|Behavioral tasks/questionnaires
16413999|NCT01212029|Device|fNIRS Devices &amp; Application|Device 1- fNIRSoft and Device 2- NIRScout
16414000|NCT01212029|Other|Physiological measures|A set of tasks
16414001|NCT01176903|Drug|Glycopyrrolate|pressurized metered dose inhaler
16414002|NCT01176903|Drug|Tiotropium|inhalation powder, hard capsule
16414003|NCT01176903|Drug|placebo|pressurized metered dose inhaler
16414004|NCT01176851|Drug|Glycopyrrolate|Single administration of Glyco pMDI 100 µg
16414005|NCT01176851|Drug|Glycopyrrolate|Single administration of Glyco pMDI 100 µg after charcoal ingestion
16414006|NCT01176851|Drug|Glycopyrrolate|Single intravenous injection of glycopyrrolate 100 µg
16414008|NCT01129609|Device|Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System|All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft
16414009|NCT01114724|Device|Valiant Thoracic Stent Graft with the Captivia Delivery System|All subjects will be implanted with this device
16414010|NCT01106521|Radiation|Permanent breast seeds implant|Patients are pre-planned using CT simulation. Implant is realised under light sedation and local freezing. Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle. Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
16414011|NCT01092767|Device|Valiant Thoracic Stent Graft with the Captivia Delivery System|All subjects will be implanted with this device
16414012|NCT01087346|Behavioral|Reading Information|Reading information about risk factors for obesity among children
16414013|NCT01086670|Other|Physical Exercise|Children will be assigned either an elliptical machine or cycle to take home. Each exercise will be performed for 20 minutes per day, 5 days per week for a period of 12 consecutive weeks, or 60 sessions in all. To avoid excessive fatigue or over-training effects, children are asked to adhere to this exact schedule and not to exercise more than this. Children are asked to complete as many of the sessions as they can. To allow for sick days or vacation during the program, the duration of the training can be extended up to 2 more weeks if needed to try to complete all 60 sessions. Compliance (percent sessions completed) will be correlated with outcomes in the statistical analyses.
16414014|NCT01036581|Device|MagPro X100 Magnetic Stimulator|Concurrent TMS-MRI acquisition allows us to investigate the acute effects of induced brain activity on BOLD signal and evaluate interference of the TMS pulse with the BOLD signal measurement.
16414015|NCT01036581|Device|Transcranial Rotating Magnetic Stimulator|Participants will undergo transcranial rapid rotating permanent magnetic stimulation (TRPMS), with the aim of evaluating the prolonged effect of TRPMS on motor cortex excitability. In another experiment, participants will undergo TRPMS with the aim of evaluating cortical excitability changes with TRPMS. These experiments will help interpret subsequent experiments investigating the effect of TRPMS on BOLD signal.
16414016|NCT00977977|Drug|Rituximab Infusion|Drug Rituximab Infusion 2 infusions (each 1000 mg) separated by 2 weeks; repeated after 6 months
16414017|NCT00977977|Drug|Oral Cyclosporine|Daily therapy for 6 months (3-5 mg/kg), then tapered and discontinued
16414018|NCT00948675|Drug|Pemetrexed|Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
16414019|NCT00948675|Drug|Carboplatin|Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.
16414020|NCT00948675|Drug|Paclitaxel|Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours
16414021|NCT00948675|Biological|Bevacizumab|Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
16414022|NCT00929851|Drug|CHF1535|Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
16414023|NCT00929851|Drug|Formoterol fumarate|Formoterol fumarate 12 µg per metered dose
16414024|NCT00924027|Radiation|HDR Brachytherapy|Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.
16414025|NCT00865969|Drug|Belinostat|
16414026|NCT00862433|Drug|Alpha tocopherol|intravenous deuterated vitamin E at doses of 2mg, 5mg, 7.5mg, 10mg and 30mg.
16414027|NCT00862433|Other|Vitamin E|Deuterated vitamin E, oral and intravenous, at doses of 2mg, 5mg, 7.5mg, 10mg and 30mg.
16414028|NCT00862433|Other|Vitamin C|Oral vitamin C, one gram daily.
16414029|NCT00816062|Device|Talent Abdominal Stent Graft|The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
16414030|NCT00798265|Biological|Gardasil|.5 mL dose injected IM at 0, 2 and 6 months
16414031|NCT00798265|Behavioral|Survey|Administration of online risk behavior and knowledge survey done at week 0.
16414032|NCT00743184|Drug|ozarelix|One single-dose vial contains 16.5 mg of ozarelix. The drug is reconstituted with 1.3 mL of diluent.
16414033|NCT00743184|Drug|Placebo|Identical placebo is also provided and reconstituted using diluent containing 0.1% saline solution.
16414034|NCT00739362|Device|Transcranial Direct Current Stimulation (TDCS)|Active tDCS (anodal left DLPFC)
16414035|NCT00739362|Other|Sham/no-stimulation|Sham tDCS
16414036|NCT00716586|Drug|2% dorzolamide|Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
16414037|NCT00705679|Drug|Emtricitabine/tenofovir disoproxil fumarate|200 mg/300 mg tablet
16414038|NCT00705679|Drug|Emtricitabine/tenofovir disoproxil fumarate placebo|placebo tablet
16414039|NCT00705679|Drug|Tenofovir disoproxil fumarate|300 mg tablet
16414040|NCT00705679|Drug|Tenofovir disoproxil fumarate placebo|placebo tablet
16414041|NCT00705679|Drug|Tenofovir 1% vaginal gel|1 gm/100 ml of 1% gel
16414042|NCT00705679|Drug|Tenofovir placebo|placebo gel
16414043|NCT00678821|Other|Aerobic exercise|Supervised aerobic exercise and educational lectures for 10 weeks
16414044|NCT00612742|Drug|testosterone gel|once daily transdermal testosterone gel, 300 mcg
16414045|NCT00612742|Drug|placebo gel|once daily transdermal placebo gel
16414046|NCT00604552|Device|AneuRx Stent Graft|Abdominal Aortic Aneurysm Repair
16414047|NCT00565851|Biological|Bevacizumab|Given IV
16414048|NCT00565851|Drug|Carboplatin|Given IV
16414049|NCT00565851|Drug|Docetaxel|Given IV
16414050|NCT00565851|Drug|Gemcitabine Hydrochloride|Given IV
16414051|NCT00565851|Other|Laboratory Biomarker Analysis|Correlative studies
16414052|NCT00565851|Drug|Paclitaxel|Given IV
16414053|NCT00565851|Other|Quality-of-Life Assessment|Ancillary studies
16414188|NCT00000902|Drug|Nelfinavir mesylate|
16414189|NCT00000902|Drug|Nevirapine|
16414054|NCT00553618|Drug|Proleukin and Dacarbazine|"IL-2 (Proleukin), injected just under the skin, at a dose of 12 million units on days 1-4 for each of the six months of therapy.
~Dacarbazine, administered as an IV infusion through a freely flowing IV, at a dose of 750 mg, repeated every four weeks."
16414055|NCT00521885|Drug|Arixtra (Fondaparinox) 2.5 mg SC Daily|Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
16414056|NCT00521885|Drug|Lovenox 40mg SC Daily|Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
16414057|NCT00507026|Drug|IV Diclofenac|IV Diclofenac q6h
16414058|NCT00507026|Drug|IV ketorolac|IV ketorolac q6h
16414059|NCT00507026|Drug|Placebo|Placebo q6h
16414060|NCT00500994|Device|MRI|The imaging study will use a block design to (i) optimize amygdala activation to emotionally balanced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/notask design. G. T2- sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three dimensional anatomical images will be taken for the co-registration of the functional images.
16414061|NCT00476099|Drug|Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI|Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
16414062|NCT00476099|Drug|Budesonide 200 µg plus formoterol 6 µg DPI|two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
16414063|NCT00476099|Drug|Formoterol 12 µg DPI|one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
16414064|NCT00400972|Device|GlideScope videolaryngoscope|
16414065|NCT00393250|Other|Hypnosis|Subjects receive hypnosis (experimental intervention) during 4 weeks of face-to-face encounters with a physician trained in hypnosis. For 6 weeks following the instruction period, the participants will perform daily self- hypnosis using customizable digital media.
16414066|NCT00393250|Other|Control|Subjects in the control arm of the study will receive face-to-face education regarding sickle cell disease for the same length and frequency as the treatment group hypnosis encounters before crossing over to the experimental intervention arm of the study
16414067|NCT00318643|Drug|Mitomycin C|intravesical administration
16414068|NCT00318643|Drug|Chemophase|intravesical administration
16414069|NCT00102544|Device|EM Tracking|Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.
16414070|NCT00098072|Procedure|Heart Catheterization|Heart Catheterization and collection of samples
16414071|NCT00097474|Drug|Hydrocortisone|Hydrocortisone will be given alone or in combination with Melatonin to see if symptoms of jet lag are alleviated
16414072|NCT00097474|Drug|Melatonin|Melatonin will be given alone or in combination with Hydrocortisone to see if symptoms of jet lag are alleviated
16414073|NCT00097474|Drug|Placebo|Placebo
16414074|NCT00092222|Drug|Etoposide|Etoposide 50 mg/m2 /day continuous intravenous infusion (CIVI) over 24 hours x 4 days (days 1-4) of 21 day cycle. A maximum of 6 cycles of R-EPOCH-R will be administered except in exceptional circumstances.
16414075|NCT00092222|Drug|Interferon-alpha|Ages 18 and over: Initial dose of 7.5 million units subcutaneous, three times weekly x 14 days; subsequent dosesincrease dose as tolerated each 14 days to a maximum of 45 million units subcutaneous three times weekly; Ages 12-17: Initial dose of 5 million units/m2 subcutaneous, three times weekly x 14 days Subsequent doses: Increase dose as tolerated each 14 days to a maximum of 30 million units/m2 subcutaneous, three times weekly
16414076|NCT00092222|Drug|Rituximab|Rituximab 375 mg/m2 IV day 1, shall be administered prior to Doxil injection. When combined with EPOCH chemotherapy, Rituximab will be given on days 1 and 5.
16414077|NCT00092222|Drug|Zidovudine|Cycle 1: Zidovudine 600 mg PO QID x 7-21 days in outpatient setting;600 mg PO q6hours x 7-21 (Intravenous zidovudine 300 mg q 6 hours may be substituted) days for inpatients; Cycle 2 and beyond: 600 mg PO QID x 7 days in outpatient setting; 600 mg PO q 6 hours x 7 days (300 mg q 6 hours may be substituted)
16414078|NCT00092222|Drug|Liposomal Doxorubicin|21 day cycle; 20 mg/m2 Liposomal Doxorubicin given on day 1 and shall be administered after completion of Rituximab infusion from 2 to 6 cycles.
16414079|NCT00092222|Drug|Bortezomib|1.3 mg/m2 IV days 1, 4, 8, and 11. Cycle length is 21 days.
16414080|NCT00092222|Drug|Valganciclovir|Cycle 1: Valganciclovir 900 mg PO BID x 7-21 days in outpatient setting; 900 mg PO q 12 hours x 7-21 days for inpatients; Cycle 2 and beyond: 900 mg PO BID x 7 days for outpatients; 900 mg PO q 12 hours x 7 days (Intravenous ganciclovir 5 mg/kg may be substituted) for inpatients
16414081|NCT00092222|Drug|Doxorubicin|10 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
16414082|NCT00092222|Drug|Vincristine|0.4 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.
16414083|NCT00092222|Drug|Cyclophosphamide|Cyclophosphamide: if CD4 < 100 cells/mm3, 187 mg/m2 IV (Day 5) if CD4 greater than or equal to 100 cells/mm3, 375 mg/m2 IV (Day 5) of 21 day cycle.
16414084|NCT00092222|Drug|Filgrastim (G-CSF)|Filgrastim 300 micrograms subcutaneous daily beginning day 6 until absolute neutrophil count recovery 5000 cells/mm3 (Pegfilgrastim may be substituted with PI approval, at the recommended dose of one 6mg syringe)
16414085|NCT00092222|Drug|Prednisone|Prednisone 60 mg/m2/day PO x 5 days (days 1-5)of 21 day cycle.
16414086|NCT00092222|Drug|Sirolimus|Maximum daily dose of 40 mg given as a single agent on 21 day cycle.
16414087|NCT00092222|Other|Observation Only|Observation of symptoms
16414088|NCT00085982|Drug|Metreleptin|Administered SQ twice/day to achieve physiological concentrations that will be effective in improving the severe state of insulin resistance seen in patients with genetic defects on their insulin receptor mutation
16414089|NCT00065676|Other|Quercetin|1 or 2 grams of quercetin or placebo will be given while patients undergo 6-hour OGTT
16414090|NCT00065676|Other|Placebo|
16414091|NCT00026559|Device|Shock Device|Shock Device
16414092|NCT00026559|Device|Auditory Startle Device|Auditory Startle Device
16414093|NCT00001563|Biological|Filgrastim|Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
16414094|NCT00001563|Biological|Rituximab|EPOCH-R every 3 weeks for up to 6 cycle
16414095|NCT00001563|Drug|EPOCH|EPOCH-R every 3 weeks for up to 6 cycle
16414190|NCT00000902|Drug|Lamivudine|
16414191|NCT00000902|Drug|Stavudine|
16414096|NCT00001521|Drug|Flutamide|Non steroidal anti-androgen that prevents the action of androgens by blocking receptor sites in target tissue. It may also produce changes in testosterone and estradiol
16414097|NCT00001521|Drug|Letrozole|Armomatase inhibitor.
16414098|NCT00001521|Drug|Hydrocortisone|reduced hydrocortisone dose can normalize the growth and adult stature of children with congenital adrenal hyperplasia
16414099|NCT00001521|Drug|Fludrocortisone|Since hydrocortisone dosage will be reduced , some patients may develop symptoms or signs of adrenal insufficiency. Patients will continue to receive an optimal fludrocortisone dose
16414100|NCT00001481|Drug|Estradiol|To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.
16414101|NCT00001481|Other|Placebo|To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.
16414102|NCT00001481|Drug|Progesterone|To determine whether it is abrupt withdrawal or prolonged exposure to gonadal steroids that is associated with PPD.
16414103|NCT00001379|Biological|Interferon|For LYG Grade 1 and 2: Interferon starting at 7.5 million Units subQ 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Patients continue taking interferon for 1 year beyond CR.
16414104|NCT00001379|Drug|Rituxan and EPOCH|For LYG Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituxan) every 3 weeks for 6 cycles.
16414105|NCT00001309|Other|Vitamin C|Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.
16414106|NCT00000967|Drug|Interferon alfa-2a|
16414107|NCT00000967|Drug|Zidovudine|
16414108|NCT00000964|Drug|Ranitidine hydrochloride|
16414109|NCT00000964|Drug|Foscarnet sodium|
16414110|NCT00000963|Drug|Didanosine|
16414111|NCT00000960|Drug|Zidovudine|
16414112|NCT00000954|Drug|Bleomycin sulfate|
16414113|NCT00000954|Drug|Vincristine sulfate|
16414114|NCT00000954|Drug|Doxorubicin hydrochloride|
16414115|NCT00000954|Drug|Zalcitabine|
16414116|NCT00000954|Drug|Didanosine|
16414117|NCT00000952|Drug|Ritonavir|
16414118|NCT00000952|Drug|Lamivudine|
16414119|NCT00000952|Drug|Zidovudine|
16414120|NCT00000951|Drug|Fluconazole|
16414121|NCT00000949|Drug|Aldesleukin|
16414122|NCT00000948|Drug|Aldesleukin|Il-2
16414123|NCT00000948|Drug|ART|antiretroviral therapy for the treatment of HIV
16414124|NCT00000946|Biological|HIV p24/MF59 Vaccine|
16414125|NCT00000946|Biological|ALVAC-HIV MN120TMG (vCP205)|
16414126|NCT00000946|Biological|ALVAC-RG Rabies Glycoprotein (vCP65)|
16414127|NCT00000946|Biological|rgp120/HIV-1 SF-2|
16414128|NCT00000945|Drug|Cidofovir|
16414129|NCT00000945|Drug|Probenecid|
16414130|NCT00000944|Drug|Indinavir sulfate|
16414131|NCT00000944|Drug|Lamivudine|
16414132|NCT00000944|Drug|Zidovudine|
16414133|NCT00000943|Biological|Tetanus Toxoid Vaccine|
16414134|NCT00000943|Biological|Hepatitis A Vaccine (Inactivated)|
16414135|NCT00000943|Biological|HIV-1 Immunogen|
16414136|NCT00000943|Biological|Hepatitis B Vaccine (Recombinant)|
16414137|NCT00000942|Drug|Nevirapine|
16414138|NCT00000941|Drug|Pravastatin sodium|
16414139|NCT00000941|Drug|Simvastatin|
16414140|NCT00000941|Drug|Atorvastatin calcium|
16414141|NCT00000941|Drug|Ritonavir|
16414142|NCT00000941|Drug|Nelfinavir mesylate|
16414143|NCT00000941|Drug|Saquinavir|
16414144|NCT00000940|Drug|Ritonavir|
16414145|NCT00000940|Drug|Abacavir sulfate|
16414146|NCT00000940|Drug|Amprenavir|
16414147|NCT00000940|Drug|Lamivudine|
16414148|NCT00000940|Drug|Stavudine|
16414149|NCT00000939|Drug|Hydroxyurea|
16414150|NCT00000939|Drug|Efavirenz|
16414151|NCT00000939|Drug|Stavudine|
16414152|NCT00000939|Drug|Didanosine|
16414153|NCT00000929|Drug|Nonoxynol-9|
16414154|NCT00000926|Drug|Nonoxynol-9|
16414155|NCT00000924|Drug|Ritonavir|
16414156|NCT00000924|Drug|Nelfinavir mesylate|
16414157|NCT00000924|Drug|Nevirapine|
16414158|NCT00000924|Drug|Stavudine|
16414159|NCT00000924|Drug|Didanosine|
16414160|NCT00000920|Drug|Ritonavir|
16414161|NCT00000920|Drug|Saquinavir|
16414162|NCT00000920|Drug|Lamivudine|
16414163|NCT00000920|Drug|Zidovudine|
16414164|NCT00000916|Drug|Indinavir sulfate|
16414165|NCT00000916|Drug|Lamivudine/Zidovudine|
16414166|NCT00000916|Drug|Hydroxyurea|
16414167|NCT00000916|Drug|Lamivudine|
16414168|NCT00000916|Drug|Stavudine|
16414169|NCT00000916|Drug|Zidovudine|
16414170|NCT00000916|Drug|Didanosine|
16414171|NCT00000914|Drug|Indinavir sulfate|
16414172|NCT00000914|Drug|Ritonavir|
16414173|NCT00000914|Drug|Nelfinavir mesylate|
16414174|NCT00000914|Drug|Efavirenz|
16414175|NCT00000913|Drug|Ritonavir|
16414176|NCT00000913|Drug|Nelfinavir mesylate|
16414177|NCT00000913|Drug|Saquinavir|
16414178|NCT00000912|Drug|Indinavir sulfate|
16414179|NCT00000912|Drug|Abacavir sulfate|
16414180|NCT00000912|Drug|Amprenavir|
16414181|NCT00000912|Drug|Nelfinavir mesylate|
16414182|NCT00000912|Drug|Efavirenz|
16414183|NCT00000912|Drug|Levocarnitine|
